The RAndomized Placebo Phase Study Of Rilonacept in the Treatment of Systemic Juvenile Idiopathic Arthritis (RAPPORT)

PubMed Central

Ilowite, Norman T.; Prather, Kristi; Lokhnygina, Yuliya; Schanberg, Laura E.; Elder, Melissa; Milojevic, Diana; Verbsky, James W.; Spalding, Steven J.; Kimura, Yukiko; Imundo, Lisa F.; Punaro, Marilynn G.; Sherry, David D.; Tarvin, Stacey E.; Zemel, Lawrence S.; Birmingham, James D.; Gottlieb, Beth S.; Miller, Michael L.; O'Neil, Kathleen; Ruth, Natasha M.; Wallace, Carol A.; Singer, Nora G.; Sandborg, Christy I.

2015-01-01

Background Interleukin-1 plays a pivotal role in in the pathogenesis of systemic juvenile idiopathic arthritis (sJIA). We assessed the efficacy and safety of rilonacept (IL-1 trap), an IL-1 inhibitor, in a randomized, double-blind, placebo-controlled trial. Methods An initial 4-week double-blind placebo phase was incorporated into a 24-week randomized multi-center design, followed by an open label phase. We randomized 71 children with at least 2 active joints 1:1 to 2 arms of the study. Patients in the rilonacept arm received rilonacept (4.4mg/kg loading dose followed by 2.2mg/kg weekly, subcutaneously) from day 0; patients in the placebo arm received placebo for 4 weeks followed by a loading dose of rilonacept at week 4 followed by weekly maintenance doses. The primary endpoint was time to response, using adapted JIA ACR30 response criteria coupled with absence of fever and taper of systemic corticosteroids using pre-specified criteria. Results Time to response was shorter in the rilonacept arm than in the placebo arm (Chi-square 7.235, P=.007). Secondary analysis showed 20/35 (57%) of patients in the rilonacept arm responded at week 4 compared to 9/33 (27%) in the placebo arm (P=.016) using the same response criteria. Exacerbation of sJIA (4) was the most common SAE. More patients in the rilonacept arm had elevated liver transaminases, including more than three times the upper limits of normal, as compared to those in the placebo arm. Adverse events were similar in the two arms of the study. Conclusions Rilonacept was generally well tolerated and demonstrated efficacy in active sJIA. PMID:24839206

Chinese herbal medicine (Ma Zi Ren Wan) for functional constipation: study protocol for a prospective, double-blinded, double-dummy, randomized controlled trial

PubMed Central

2013-01-01

Background Functional constipation is a common clinical complaint. Although the effectiveness of Ma Zi Ren Wan for alleviating functional constipation symptoms has been proven in a previous randomized placebo-controlled study, further evidence is needed to make clinical recommendations about Chinese herbal medicine. In particular, a comparison with conventional western medicine for functional constipation patients is needed. Methods/Design This is a prospective, double-blinded, double dummy, randomized, controlled trial. After a 2-week run-in period, eligible patients (Rome III) with excessive traditional Chinese medicine syndrome will randomly be assigned to the Chinese medicine arm (Ma Zi Ren Wan and western medicine placebo), western medicine arm (senna and Chinese medicine placebo) or placebo arm (Chinese medicine placebo and western medicine placebo). Patients will undergo an 8-week treatment and an 8-week follow-up. The primary outcome is the responder rate for complete spontaneous bowel movement (CSBM) during treatment. Patients with a mean increase of CSBM ≧1/week in comparison with their baselines are defined as responders. The secondary outcomes include responder rate during follow-up, changes of colonic transit as measured with radio-opaque markers, individual and global symptom assessments, and reported adverse effects. Discussion This study is the first study to compare a Chinese Herbal Medicine (Ma Zi Ren Wan) with a laxative that is commonly used in the clinical practice of western medicine, and with a placebo. This study will complete the investigation of Ma Zi Ren Wan for functional constipation, and should, therefore, suggest recommendations for clinical practice. Furthermore, the process of first conducting a systematic review, then implementing a dose determination study followed by a placebo-control trial, and finally, comparing traditional Chinese medicine with an active conventional medicine in a controlled trial can be a reference to other researches on Chinese medicine interventions in the future. Trial registration NCT01695850 PMID:24180235

Study protocol for a randomised controlled double-blinded trial of the dose-dependent efficacy and safety of primaquine for clearance of gametocytes in children with uncomplicated falciparum malaria in Uganda.

PubMed

Eziefula, Alice Chijioke; Staedke, Sarah G; Yeung, Shunmay; Webb, Emily; Kamya, Moses; White, Nicholas J; Bousema, Teun; Drakeley, Chris

2013-03-26

For the purpose of blocking transmission of Plasmodium falciparum malaria from humans to mosquitoes, a single dose of primaquine is recommended by the WHO as an addition to artemisinin combination therapy. Primaquine clears gametocytes but causes dose-dependent haemolysis in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Evidence is needed to inform the optimal dosing of primaquine for malaria elimination programmes and for the purpose of interrupting the spread of artemisinin-resistant malaria. This study investigates the efficacy and safety of reducing doses of primaquine for clearance of gametocytes in participants with normal G6PD status. In this prospective, four-armed randomised placebo-controlled double-blinded trial, children aged 1-10 years, weighing over 10 kg, with haemoglobin ≥8 g/dl and uncomplicated P falciparum malaria are treated with artemether lumefantrine and randomised to receive a dose of primaquine (0.1, 0.4 or 0.75 mg base/kg) or placebo on the third day of treatment. Participants are followed up for 28 days. Gametocytaemia is measured by quantitative nucleic acid sequence-based analysis on days 0, 2, 3, 7, 10 and 14 with a primary endpoint of the number of days to gametocyte clearance in each treatment arm and secondarily the area under the curve of gametocyte density over time. Analysis is for non-inferiority of efficacy compared to the reference dose, 0.75 mg base/kg. Safety is assessed by pair-wise comparisons of the arithmetic mean (±SD) change in haemoglobin concentration per treatment arm and analysed for superiority to placebo and incidence of adverse events. Ethics and dissemination Approval was obtained from the ethical committees of Makerere University School of Medicine, the Ugandan National Council of Science and Technology and the London School of Hygiene and Tropical Medicine. These will be disseminated to inform malaria elimination policy, through peer-reviewed publication and academic presentations.

Chinese herbal medicine (Ma Zi Ren Wan) for functional constipation: study protocol for a prospective, double-blinded, double-dummy, randomized controlled trial.

PubMed

Zhong, Linda L D; Cheng, Chung Wah; Chan, Yawen; Chan, King Hong; Lam, Ting Wa; Chen, Xiao Rui; Wong, Chi Tak; Wu, Justin C Y; Bian, Zhao Xiang

2013-11-04

Functional constipation is a common clinical complaint. Although the effectiveness of Ma Zi Ren Wan for alleviating functional constipation symptoms has been proven in a previous randomized placebo-controlled study, further evidence is needed to make clinical recommendations about Chinese herbal medicine. In particular, a comparison with conventional western medicine for functional constipation patients is needed. This is a prospective, double-blinded, double dummy, randomized, controlled trial. After a 2-week run-in period, eligible patients (Rome III) with excessive traditional Chinese medicine syndrome will randomly be assigned to the Chinese medicine arm (Ma Zi Ren Wan and western medicine placebo), western medicine arm (senna and Chinese medicine placebo) or placebo arm (Chinese medicine placebo and western medicine placebo). Patients will undergo an 8-week treatment and an 8-week follow-up. The primary outcome is the responder rate for complete spontaneous bowel movement (CSBM) during treatment. Patients with a mean increase of CSBM ≧1/week in comparison with their baselines are defined as responders. The secondary outcomes include responder rate during follow-up, changes of colonic transit as measured with radio-opaque markers, individual and global symptom assessments, and reported adverse effects. This study is the first study to compare a Chinese Herbal Medicine (Ma Zi Ren Wan) with a laxative that is commonly used in the clinical practice of western medicine, and with a placebo. This study will complete the investigation of Ma Zi Ren Wan for functional constipation, and should, therefore, suggest recommendations for clinical practice. Furthermore, the process of first conducting a systematic review, then implementing a dose determination study followed by a placebo-control trial, and finally, comparing traditional Chinese medicine with an active conventional medicine in a controlled trial can be a reference to other researches on Chinese medicine interventions in the future. NCT01695850.

Contact force sensing for ablation of persistent atrial fibrillation: A randomized, multicenter trial.

PubMed

Conti, Sergio; Weerasooriya, Rukshen; Novak, Paul; Champagne, Jean; Lim, Hong Euy; Macle, Laurent; Khaykin, Yaariv; Pantano, Alfredo; Verma, Atul

2018-02-01

Impact of contact force sensing (CFS) on ablation of persistent atrial fibrillation (PeAF) is unknown. The purpose of the TOUCH AF (Therapeutic Outcomes Using Contact force Handling during Ablation of Persistent Atrial Fibrillation) randomized trial was to compare CFS-guided ablation to a CFS-blinded strategy. Patients (n = 128) undergoing first-time ablation for persistent AF were randomized to a CFS-guided vs CFS-blinded strategy. In the CFS-guided procedure, operators visualized real-time force data. In the blinded procedure, force data were hidden. Wide antral pulmonary vein isolation plus a roof line were performed. Patients were followed at 3, 6, 9, and 12 months with clinical visit, ECG, and 48-hour Holter monitoring. The primary endpoint was cumulative radiofrequency (RF) time for all procedures. Atrial arrhythmia >30 seconds after 3 months was a recurrence. PeAF was continuous for 26 weeks (interquartile range [IQR] 13-52), and left atrial size was 45 ± 5 mm. Force in the CFS-blinded and CFS-guided arms was 12 g [IQR 6-20] and 14 g [IQR 9-20] (P = .10), respectively. Total RF time did not differ between CFS-guided and CFS-blinded groups (49 ± 14 min vs 50 ± 20 min, respectively; P = .70). Single procedure freedom from atrial arrhythmia was 60% in the CFS-guided arm and 63% in the CFS-blinded arm off drugs. Lesions with gaps were associated with significantly less force (11.4 g [IQR 6-19] vs 13.2 g [IQR 8-20], respectively; P = .0007) and less force-time integral (174 gs [IQR 91-330] vs 210 gs [IQR 113-388], respectively; P <.001). CFS-guided ablation resulted in no difference to RF time or 12-month outcome. Lower force/force-time integral was associated with significantly more gaps. Copyright © 2017 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

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

Impairment-oriented training or Bobath therapy for severe arm paresis after stroke: a single-blind, multicentre randomized controlled trial.

PubMed

Platz, T; Eickhof, C; van Kaick, S; Engel, U; Pinkowski, C; Kalok, S; Pause, M

2005-10-01

To study the effects of augmented exercise therapy time for arm rehabilitation as either Bobath therapy or the impairment-oriented training (Arm BASIS training) in stroke patients with arm severe paresis. Single blind, multicentre randomized control trial. Three inpatient neurorehabilitation centres. Sixty-two anterior circulation ischaemic stroke patients. Random assignment to three group: (A) no augmented exercise therapy time, (B) augmented exercise therapy time as Bobath therapy and (C) augmented exercise therapy time as Arm BASIS training. Fugl-Meyer arm motor score. Secondary measure: Action Research Arm Test (ARA). Ancillary measures: Fugl-Meyer arm sensation and joint motion/pain scores and the Ashworth Scale (elbow flexors). An overall effect of augmented exercise therapy time on Fugl-Meyer scores after four weeks was not corroborated (mean and 95% confidence interval (CI) of change scores: no augmented exercise therapy time (n=20) 8.8, 5.2-12.3; augmented exercise therapy time (n=40) 9.9, 6.8-13.9; p = 0.2657). The group who received the augmented exercise therapy time as Arm BASIS training (n=20) had, however, higher gains than the group receiving the augmented exercise therapy time as Bobath therapy (n=20) (mean and 95% CI of change scores: Bobath 7.2, 2.6-11.8; BASIS 12.6, 8.4-16.8; p = 0.0432). Passive joint motion/pain deteriorated less in the group who received BASIS training (mean and 95% CI of change scores: Bobath -3.2, -5.2 to -1.1; BASIS 0.1, -1.8-2.0; p = 0.0090). ARA, Fugl-Meyer arm sensation, and Ashworth Scale scores were not differentially affected. The augmented exercise therapy time as Arm BASIS training enhanced selective motor control. Type of training was more relevant for recovery of motor control than therapeutic time spent.

Memory systems in the rat: effects of reward probability, context, and congruency between working and reference memory.

PubMed

Roberts, William A; Guitar, Nicole A; Marsh, Heidi L; MacDonald, Hayden

2016-05-01

The interaction of working and reference memory was studied in rats on an eight-arm radial maze. In two experiments, rats were trained to perform working memory and reference memory tasks. On working memory trials, they were allowed to enter four randomly chosen arms for reward in a study phase and then had to choose the unentered arms for reward in a test phase. On reference memory trials, they had to learn to visit the same four arms on the maze on every trial for reward. Retention was tested on working memory trials in which the interval between the study and test phase was 15 s, 15 min, or 30 min. At each retention interval, tests were performed in which the correct WM arms were either congruent or incongruent with the correct RM arms. Both experiments showed that congruency interacted with retention interval, yielding more forgetting at 30 min on incongruent trials than on congruent trials. The effect of reference memory strength on the congruency effect was examined in Experiment 1, and the effect of associating different contexts with working and reference memory on the congruency effect was studied in Experiment 2.

Electrical stimulation for chronic non-specific low back pain in a working-age population: a 12-week double blinded randomized controlled trial.

PubMed

Thiese, Matthew S; Hughes, Matthew; Biggs, Jeremy

2013-03-28

Non-invasive electrotherapy is commonly used for treatment of chronic low back pain. Evidence for efficacy of most electrotherapy modalities is weak or lacking. This study aims to execute a high-quality, double-blinded randomized controlled clinical trial comparing 1) H-Wave(®) Device stimulation plus usual care with 2) transcutaneous electrical nerve stimulation (TENS) plus usual care, and 3) Sham electrotherapy plus usual care to determine comparative efficacy for treatment of chronic non-specific low back pain patients. Chronic non-specific low back pain patients between ages of 18-65 years, with pain of at least 3 months duration and minimal current 5/10 VAS pain. Patients will have no significant signs or symptoms of lumbosacral nerve impingement, malignancy, spinal stenosis, or mood disorders. Double blind RCT with 3 arms and 38 subjects per arm. Randomization by permuted blocks of random length, stratified by Workers Compensation claim (yes vs. no), and use of opioids. The null hypothesis of this study is that there are no statistically significant differences in functional improvement between treatment types during and at the end of a 12-week week treatment period. Subjective data will be collected using Filemaker Pro™ database management collection tools. Objective data will be obtained through functional assessments. Data will be collected at enrollment and at 1, 4, 8, and 12 weeks for each participant by a blinded assessor. H-Wave(®) device stimulation (Intervention A) plus usual care, transcutaneous electrical nerve stimulation (TENS) (Intervention B) plus usual care, and sham electrotherapy plus usual care (control). Each treatment arm will have identical numbers of visits (4) and researcher contact time (approximately 15 hours). Oswestry Disability Index. Secondary measures include: Rowland Morris Instrument, VAS pain score, functional evaluation including strength when pushing and pulling, pain free range of motion in flexion and extension. Outcome measures assessed at baseline, 1, 4, 8, and 12 weeks. Treatment failure will be defined if patient terminates assigned treatment arm for non-efficacy or undergoes invasive procedure or other excluded cointerventions. Data will be analyzed using intention-to-treat analysis and adjusted for covariates related to LBP (e.g. age) as needed. Study strengths include complex randomization, treatment group allocation concealment, double blinding, controlling for co-interventions, rigorous inclusion criteria, assessment of compliance, plans for limiting dropout, identical assessment methods and timing for each treatment arm, and planned intention-to-treat analyses.

Changes in the bilateral pulse transit time difference with a moving arm.

PubMed

Jiang, Xinge; Wei, Shoushui; Zheng, Dingchang; Huang, Peng; Liu, Chengyu

2018-04-20

Changes of pulse transit time (PTT) induced by arm position were studied for unilateral arm. However, consistency of the PTT changes was not validated for both arm sides. We aimed to quantify the PTT changes between horizontal and non-horizontal positions from right arm and left arm in order to explore the consistency of both arms. Twenty-four normal subjects aged between 21 and 50 (14 male and 10 female) years were enrolled. Left and right radial artery pulses were synchronously recorded from 24 healthy subjects with one arm (left or right) at five angles (90∘, 45∘, 0∘, -45∘ and -90∘) and the other arm at the horizontal level (0∘) for reference. The overall mean PTT changes at the five angles (from 90∘ to -90∘) in the left arm (right as reference) were 16.1, 12.3, -0.5, -2.5 and -2.6 ms, respectively, and in the right arm (left as reference) were 18.0, 12.6, 1.6, -1.6 and -2.0 ms, respectively. Obvious differences were not found in the PTT changes between the two arms (left arm moving or right arm moving) under each of the five different positions (all P> 0.05).

Effects of 6 months of resveratrol versus placebo on pentraxin 3 in patients with type 2 diabetes mellitus: a double-blind randomized controlled trial.

PubMed

Bo, S; Ponzo, V; Evangelista, A; Ciccone, G; Goitre, I; Saba, F; Procopio, M; Cassader, M; Gambino, R

2017-05-01

The anti-inflammatory effects of the polyphenol resveratrol in patients with type 2 diabetes mellitus (T2DM) are controversial. Its role on pentraxin 3 (PTX3) concentrations, a human acute phase protein, has never been evaluated. Our aim was to determine whether a two-dosage resveratrol supplementation (500 and 40 mg/day) has an impact on PTX3 values in T2DM patients from a double-blind randomized placebo-controlled trial. Variations in total antioxidant status (TAS) were evaluated too. A total of 192 T2DM patients were randomized to receive resveratrol 500 mg/day (Resv 500 arm), resveratrol 40 mg/day (Resv 40 arm) or placebo for 6 months. At baseline and at the trial end, PTX3 and TAS values were determined. A dose-dependent increase in PTX3 concentrations of 4.7% (Resv 40 arm) and 26.3% (Resv 500 arm), and 8.0% reduction after placebo were found. Adjusted mean differences of change versus placebo were 0.16 (95% CI 0.01-0.32) and 0.25 (0.09-0.42) in the Resv 40 and Resv 500 arms, respectively. At subgroup analyses, lower diabetes duration, aspirin, alcohol use, younger age, female gender, smoking (Resv 500 arm) and female gender and aspirin use (Resv 40 arm) were associated with higher PTX3 increments. A dose-dependent increment in TAS values in the resveratrol arms (1.4 and 6.4% for Resv 40 and Resv 500, respectively), and a reduction in placebo arm (-8.9%) were observed. Adjusted mean differences of change were 28.5 (95% CI 10.1-46.8) and 44.8 (25.4-64.1) in the Resv 40 and Resv 500 arms, respectively. Resveratrol supplementation increased PTX3 and TAS levels in a dose-dependent manner in T2DM patients. At present, potential clinical implications of these results remain unclear. CLINICALTRIALS. NCT02244879.

A Double-Blind Placebo-Controlled Randomized Clinical Trial With Magnesium Oxide to Reduce Intrafraction Prostate Motion for Prostate Cancer Radiotherapy

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

Lips, Irene M., E-mail: i.m.lips@umcutrecht.nl; Gils, Carla H. van; Kotte, Alexis N.T.J.

2012-06-01

Purpose: To investigate whether magnesium oxide during external-beam radiotherapy for prostate cancer reduces intrafraction prostate motion in a double-blind, placebo-controlled randomized trial. Methods and Materials: At the Department of Radiotherapy, prostate cancer patients scheduled for intensity-modulated radiotherapy (77 Gy in 35 fractions) using fiducial marker-based position verification were randomly assigned to receive magnesium oxide (500 mg twice a day) or placebo during radiotherapy. The primary outcome was the proportion of patients with clinically relevant intrafraction prostate motion, defined as the proportion of patients who demonstrated in {>=}50% of the fractions an intrafraction motion outside a range of 2 mm. Secondarymore » outcome measures included quality of life and acute toxicity. Results: In total, 46 patients per treatment arm were enrolled. The primary endpoint did not show a statistically significant difference between the treatment arms with a percentage of patients with clinically relevant intrafraction motion of 83% in the magnesium oxide arm as compared with 80% in the placebo arm (p = 1.00). Concerning the secondary endpoints, exploratory analyses demonstrated a trend towards worsened quality of life and slightly more toxicity in the magnesium oxide arm than in the placebo arm; however, these differences were not statistically significant. Conclusions: Magnesium oxide is not effective in reducing the intrafraction prostate motion during external-beam radiotherapy, and therefore there is no indication to use it in clinical practice for this purpose.« less

Achromatic self-referencing interferometer

DOEpatents

Feldman, Mark

1994-01-01

A self-referencing Mach-Zehnder interferometer for accurately measuring laser wavefronts over a broad wavelength range (for example, 600 nm to 900 nm). The apparatus directs a reference portion of an input beam to a reference arm and a measurement portion of the input beam to a measurement arm, recombines the output beams from the reference and measurement arms, and registers the resulting interference pattern ("first" interferogram) at a first detector. Optionally, subportions of the measurement portion are diverted to second and third detectors, which respectively register intensity and interferogram signals which can be processed to reduce the first interferogram's sensitivity to input noise. The reference arm includes a spatial filter producing a high quality spherical beam from the reference portion, a tilted wedge plate compensating for off-axis aberrations in the spatial filter output, and mirror collimating the radiation transmitted through the tilted wedge plate. The apparatus includes a thermally and mechanically stable baseplate which supports all reference arm optics, or at least the spatial filter, tilted wedge plate, and the collimator. The tilted wedge plate is mounted adjustably with respect to the spatial filter and collimator, so that it can be maintained in an orientation in which it does not introduce significant wave front errors into the beam propagating through the reference arm. The apparatus is polarization insensitive and has an equal path length configuration enabling measurement of radiation from broadband as well as closely spaced laser line sources.

Interaction between vibration-evoked proprioceptive illusions and mirror-evoked visual illusions in an arm-matching task.

PubMed

Tsuge, Mikio; Izumizaki, Masahiko; Kigawa, Kazuyoshi; Atsumi, Takashi; Homma, Ikuo

2012-12-01

We studied the influence of false proprioceptive information generated by arm vibration and false visual information provided by a mirror in which subjects saw a reflection of another arm on perception of arm position, in a forearm position-matching task in right-handed subjects (n = 17). The mirror was placed between left and right arms, and arranged so that the reflected left arm appeared to the subjects to be their unseen right (reference) arm. The felt position of the right arm, indicated with a paddle, was influenced by vision of the mirror image of the left arm. If the left arm appeared flexed in the mirror, subjects felt their right arm to be more flexed than it was. Conversely, if the left arm was extended, they felt their right arm to be more extended than it was. When reference elbow flexors were vibrated at 70-80 Hz, an illusion of extension of the vibrated arm was elicited. The illusion of a more flexed reference arm evoked by seeing a mirror image of the flexed left arm was reduced by vibration. However, the illusion of extension of the right arm evoked by seeing a mirror image of the extended left arm was increased by vibration. That is, when the mirror and vibration illusions were in the same direction, they reinforced each other. However, when they were in opposite directions, they tended to cancel one another. The present study shows the interaction between proprioceptive and visual information in perception of arm position.

40 CFR 1065.310 - Torque calibration.

Code of Federal Regulations, 2014 CFR

2014-07-01

... force is measured. The lever arm must be perpendicular to gravity (i.e., horizontal), and it must be... known distance along a lever arm. Make sure the weights' lever arm is perpendicular to gravity (i.e... Earth's gravity, as described in § 1065.630. Calculate the reference torque as the weights' reference...

A randomized, double-blind, placebo-controlled trial of infliximab in refractory polymyositis and dermatomyositis.

PubMed

Schiffenbauer, Adam; Garg, Megha; Castro, Christine; Pokrovnichka, Angelina; Joe, Galen; Shrader, Joseph; Cabalar, Imelda Victoria; Faghihi-Kashani, Sara; Harris-Love, Michael O; Plotz, Paul H; Miller, Frederick W; Gourley, Mark

2018-06-01

To investigate in a pilot study the safety and efficacy of infliximab in patients with refractory dermatomyositis (DM) and polymyositis (PM). A randomized, double-blind, placebo-controlled trial including subjects with active DM or PM. Participants had stable doses of immunosuppressive medication and prednisone (≤0.5mg/kg/day), and exhibited clinical signs of muscle weakness for at least 4 weeks prior to study entry. Participants received infusions of either placebo or infliximab 5mg/kg at 0, 2, 6, and 14 weeks in blinded manner. The primary outcome was a ≥15% manual muscle strength (MMT) improvement at week 16 compared to week 0. The secondary outcome measures were improvement defined by the International Myositis Assessment and Clinical Studies Group (IMACS) criteria. At week 16, responders in each arm had the option of either continuing the same treatment or changing to the non-responder treatment for that study arm. Non-responders in the 5mg/kg infliximab arm were increased to infliximab 7.5mg/kg for weeks 22, 30, and 38. Non-responders in the placebo arm at week 16 received infliximab 5mg/kg at weeks 16, 18, 22, 30, and 38. Outcomes were reassessed at week 40. Twelve subjects completed the study to week 16. Six of the 12 subjects received infliximab treatment at the dose of 5mg/kg with only one subject meeting the responder criteria at that dose. Of the remaining five subjects on infliximab, three crossed over to the infliximab 7.5mg/kg dose. One of those three subjects responded. All six patients in the placebo arm crossed over to the 5mg/kg dosing regimen after week 16, and two of those responded to infliximab. Infliximab therapy for patients with refractory PM and DM was well tolerated and may benefit a subset of patients. Published by Elsevier Inc.

Effectiveness of a multimodal standard nursing program on health-related quality of life in Chinese mainland female patients with breast cancer: protocol for a single-blind cluster randomized controlled trial.

PubMed

Zhou, Kaina; Wang, Duolao; He, Xiaole; Huo, Lanting; An, Jinghua; Li, Minjie; Wang, Wen; Li, Xiaomei

2016-08-31

Breast cancer and its treatment-related adverse effects are harmful to physical, psychological, and social functioning, leading to health-related quality of life (HRQoL) impairment in patients. Many programs have been used with this population for HRQoL improvement; however, few studies have considered the physical, psychological, and social health domains comprehensively, and few have constructed multimodal standard nursing interventions based on specific theories. The purpose of this trial is to examine the effect of a health belief model (HBM)-based multimodal standard nursing program (MSNP) on HRQoL in female patients with breast cancer. This is a two-arm single-blind cluster randomized controlled trial (cRCT) in clinical settings. Twelve tertiary hospitals will be randomly selected from the 24 tertiary hospitals in Xi'an, China, and allocated to the intervention arm and control arm using a computer-generated random numbers table. Inpatient female patients with breast cancer from each hospital will receive either MSNP plus routine nursing care immediately after recruitment (intervention arm), or only routine nursing care (control arm). The intervention will be conducted by trained nurses for 12 months. All recruited female patients with breast cancer, participating clinical staff, and trained data collectors from the 12 hospitals will be blind with respect to group allocation. Patients of the control arm will not be offered any information about the MSNP during the study period to prevent bias. The primary outcome is HRQoL measured through the Functional Assessment of Cancer Therapy-Breast version 4.0 at 12 months. Secondary outcomes include pain, fatigue, sleep, breast cancer-related lymphedema, and upper limb function, which are evaluated by a visual analogue scale, the circumference method, and the Constant-Murley Score. This trial will provide important evidence on the effectiveness of multimodal nursing interventions delivered by nurses in clinical settings. Study findings will inform strategies for scaling up comprehensive standard intervention programs on health management in the population of female patients with breast cancer. Chictr.org.cn ChiCTR-IOR-16008253 (April 9, 2016).

Double-Blind Controlled Comparison of Phlebitis Produced by Cephapirin and Cephalothin

PubMed Central

Carrizosa, Jaime; Levison, Matthew E.; Kaye, Donald

1973-01-01

In a double-blind study with each patient as his own control cephapirin and cephalothin were administered to 20 patients in opposite arms for a period of 48 hr each. Neither the incidence of phlebitis nor the degree of phlebitis was significantly different with the two drugs, and there was no difference in the time of onset of pain or phlebitis. PMID:4597719

A randomized, blinded, multicenter trial of a gentamicin vancomycin gel (DFA-02) in patients undergoing abdominal surgery.

PubMed

Bennett-Guerrero, Elliott; Berry, Scott M; Bergese, Sergio D; Fleshner, Phillip R; Minkowitz, Harold S; Segura-Vasi, Alvaro M; Itani, Kamal M F; Henderson, Karen W; Rackowski, Felicia P; Aberle, Laura H; Stryjewski, Martin E; Corey, G Ralph; Allenby, Kent S

2017-06-01

SI is a significant medical problem. DFA-02 is an investigational bioresorbable modified release gel consisting of both gentamicin (16.8 mg/mL) and vancomycin (18.8 mg/mL). A Phase 2a study, where the drug was applied during surgical incision closure, suggested safety and tolerability but was not designed to assess its efficacy. In a Phase 2b randomized, blinded trial patients undergoing abdominal, primarily colorectal, surgery were randomized (4:1:1) to one of three study arms: DFA-02, matching placebo gel, or standard of care (SOC) involving irrigation of the wound with normal saline. The DFA-02 and placebo gel groups received up to 20 mL of study drug inserted above the fascia during wound closure, and were treated in a double-blind manner; the SOC group was treated in a single-blind manner. The primary endpoint was SSI (adjudicated centrally by a blinded committee) through postoperative day 30. Overall, 445 subjects (intention-to-treat) were randomized at 35 centers with 425 subjects completing the study and being evaluable. There were 67 SSIs (15.8%): 64.2% superficial, 7.5% deep, and 28.4% organ space. The incidence of SSI was not statistically significantly different between the DFA-02 and the placebo gel/SOC arms combined, 42/287 = 14.6% vs 25/138 = 18.1% (p = 0.36), respectively. Rehospitalization within 30 days was also similar between study groups (DFA-02 28.6%, placebo gel 21.4%, SOC 27.3%). In this multicenter, blinded, randomized trial with central adjudication, the gentamicin/vancomycin gel was not associated with a significant reduction in SSI. Patients undergoing abdominal surgery were randomized to one of three study arms: DFA-02 gel consisting of both gentamicin and vancomycin, matching placebo gel, or standard of care (SOC). Of 425 patients completing the study at 35 sites the gentamicin/vancomycin gel was not associated with a significant reduction in SSI. Copyright © 2016 Elsevier Inc. All rights reserved.

Mechanical arm trainer for the treatment of the severely affected arm after a stroke: a single-blinded randomized trial in two centers.

PubMed

Hesse, S; Werner, C; Pohl, M; Mehrholz, J; Puzich, U; Krebs, H I

2008-10-01

To test whether training with a new mechanical arm trainer leads to better outcomes than electrical stimulation of the paretic wrist extensors in subacute stroke patients with severe upper limb paresis. Electrical stimulation is a standard and reimbursable form of therapy in Germany. Randomized controlled trial of 54 inpatients enrolled 4-8 wks from stroke onset, mean upper-extremity subsection of Fugl-Meyer assessment (0-66) at admission less than 18. In addition to standard care, all patients practiced 20-30 mins arm trainer or electrical stimulation every workday for 6 wks, totaling 30 sessions. Primary outcome was the Fugl-Meyer assessment, secondary outcomes were the Box and Block test, the Medical Research Council and the modified Ashworth scale, blindly assessed at enrollment, after 6 wks, and at 3-mo follow-up. Both groups were homogeneous at study onset. Shoulder pain occurred in two arm trainer patients. The primary Fugl-Meyer assessment outcome improved for both groups over time (P < 0.001), but this improvement did not differ between groups. The initial (terminal) mean Fugl-Meyer assessment scores were 8.8 +/- 4.8 (19.2 +/- 14.5) for the arm trainer and 8.6 +/- 3.5 (13.6 +/- 7.9) for the electrical stimulation group. No patient could transport a block initially, but at completion significantly more arm trainer patients were able to transport at least three blocks (five vs. zero, P = 0.023). No significant differences were observed between the groups on the secondary Box and Block outcome at follow-up (eight vs. four patients). All Box and Block responders had an initial Fugl-Meyer assessment > or =10. Arm trainer training did not lead to a superior primary outcome over electrical stimulation training. However, "good performers" on the secondary outcome seemed to benefit more from the arm trainer training.

Flexible kinesthetic distance perception: when do your arms tell you how far you have walked?

PubMed

Harrison, Steven J; Kuznetsov, Nikita; Breheim, Samuel

2013-01-01

Given the flexible organization of locomotion evidenced in the many ways the limbs can be coordinated, the authors explored the potentially correspondingly flexible organization of nonvisual (kinesthetic) distance perception. As kinesthetic distance perception is known to be affected by how the limbs are coordinated, the authors probed the potential perceptual contribution of the arms during locomotion by manipulating arm-leg coordination patterns in blind-walked distance-matching tasks. Whereas manipulation of arm-leg coordination for walking with free-swinging arms had no observable perceptual consequences, comparable manipulation for walking with hiking poles did affect distance matching. These results suggest that under conditions in which the arms act to propel the body (e.g., crawling or stair-climbing) a person's nonvisual sense of movement is conveyed in the coordinated actions of all four limbs.

Small studies may overestimate the effect sizes in critical care meta-analyses: a meta-epidemiological study

PubMed Central

2013-01-01

Introduction Small-study effects refer to the fact that trials with limited sample sizes are more likely to report larger beneficial effects than large trials. However, this has never been investigated in critical care medicine. Thus, the present study aimed to examine the presence and extent of small-study effects in critical care medicine. Methods Critical care meta-analyses involving randomized controlled trials and reported mortality as an outcome measure were considered eligible for the study. Component trials were classified as large (≥100 patients per arm) and small (<100 patients per arm) according to their sample sizes. Ratio of odds ratio (ROR) was calculated for each meta-analysis and then RORs were combined using a meta-analytic approach. ROR<1 indicated larger beneficial effect in small trials. Small and large trials were compared in methodological qualities including sequence generating, blinding, allocation concealment, intention to treat and sample size calculation. Results A total of 27 critical care meta-analyses involving 317 trials were included. Of them, five meta-analyses showed statistically significant RORs <1, and other meta-analyses did not reach a statistical significance. Overall, the pooled ROR was 0.60 (95% CI: 0.53 to 0.68); the heterogeneity was moderate with an I2 of 50.3% (chi-squared = 52.30; P = 0.002). Large trials showed significantly better reporting quality than small trials in terms of sequence generating, allocation concealment, blinding, intention to treat, sample size calculation and incomplete follow-up data. Conclusions Small trials are more likely to report larger beneficial effects than large trials in critical care medicine, which could be partly explained by the lower methodological quality in small trials. Caution should be practiced in the interpretation of meta-analyses involving small trials. PMID:23302257

Achromatic self-referencing interferometer

DOEpatents

Feldman, M.

1994-04-19

A self-referencing Mach-Zehnder interferometer is described for accurately measuring laser wavefronts over a broad wavelength range (for example, 600 nm to 900 nm). The apparatus directs a reference portion of an input beam to a reference arm and a measurement portion of the input beam to a measurement arm, recombines the output beams from the reference and measurement arms, and registers the resulting interference pattern ([open quotes]first[close quotes] interferogram) at a first detector. Optionally, subportions of the measurement portion are diverted to second and third detectors, which respectively register intensity and interferogram signals which can be processed to reduce the first interferogram's sensitivity to input noise. The reference arm includes a spatial filter producing a high quality spherical beam from the reference portion, a tilted wedge plate compensating for off-axis aberrations in the spatial filter output, and mirror collimating the radiation transmitted through the tilted wedge plate. The apparatus includes a thermally and mechanically stable baseplate which supports all reference arm optics, or at least the spatial filter, tilted wedge plate, and the collimator. The tilted wedge plate is mounted adjustably with respect to the spatial filter and collimator, so that it can be maintained in an orientation in which it does not introduce significant wave front errors into the beam propagating through the reference arm. The apparatus is polarization insensitive and has an equal path length configuration enabling measurement of radiation from broadband as well as closely spaced laser line sources. 3 figures.

Magnitude of blood pressure reduction in the placebo arms of modern hypertension trials: implications for trials of renal denervation.

PubMed

Patel, Hitesh C; Hayward, Carl; Ozdemir, Baris Ata; Rosen, Stuart D; Krum, Henry; Lyon, Alexander R; Francis, Darrel P; di Mario, Carlo

2015-02-01

Early phase studies of novel interventions for hypertension, such as renal sympathetic denervation, are sometimes single-armed (uncontrolled). We explored the wisdom of this by quantifying the blood pressure fall in the placebo arms of contemporary trials of hypertension. We searched Medline up to June 2014 and identified blinded, randomized trials of hypertension therapy in which the control arm received placebo medication or a sham (placebo) procedure. For nonresistant hypertension, we have identified all such trials of drugs licensed by the US Food and Drug Administration since 2000 (5 drugs). This US Food and Drug Administration-related restriction was not applied to resistant hypertension trials. This produced 7451 patients, who were allocated to a blinded control from 52 trials of nonresistant hypertension and 694 patients from 8 trials of resistant hypertension (3 drugs and 2 interventions). Systolic blood pressure fell by 5.92 mm Hg (95% confidence interval, 5.14-6.71; P<0.0001) in the nonresistant cohort and by 8.76 mm Hg (95% confidence interval, 4.83-12.70; P<0.0001) in the resistant cohort. Using metaregression, the falls were larger in trials that did not use ambulatory blood pressure monitoring as an inclusion criterion (z=2.84; P=0.0045), in those with higher baseline blood pressures (z=-0.3; P=0.0001), and in those where the patients were prescribed a continuous background of antihypertensives (z=-2.72; P=0.0065). The nontrivial magnitude of these apparent blood pressure reductions with perfectly ineffective intervention (placebo) illustrates that efficacy explorations of novel therapies for hypertension, once safety is established, should be performed with a randomized, appropriately controlled, and blinded design. © 2014 American Heart Association, Inc.

Double-Blind Comparison of Phlebitis Produced by Cephalothin Infusions with Buffered and Unbuffered Diluents

PubMed Central

Carrizosa, Jaime; Levison, Matthew E.; Kaye, Donald

1974-01-01

In a double-blind study with each patient as his own control, a buffered and an unbuffered cephalothin solution was administered to 13 patients in opposite arms for a period of 48 h each. Neither the incidence of phlebitis nor the degree of phlebitis was different with the two diluents, and there was no difference in the time of onset of phlebitis. PMID:4840431

Association of prenatal lipid-based nutritional supplementation with fetal growth in rural Gambia.

PubMed

Johnson, William; Darboe, Momodou K; Sosseh, Fatou; Nshe, Patrick; Prentice, Andrew M; Moore, Sophie E

2017-04-01

Prenatal supplementation with protein-energy (PE) and/or multiple-micronutrients (MMNs) may improve fetal growth, but trials of lipid-based nutritional supplements (LNSs) have reported inconsistent results. We conducted a post-hoc analysis of non-primary outcomes in a trial in Gambia, with the aim to test the associations of LNS with fetal growth and explore how efficacy varies depending on nutritional status. The sample comprised 620 pregnant women in an individually randomized, partially blinded trial with four arms: (a) iron and folic acid (FeFol) tablet (usual care, referent group), (b) MMN tablet, (c) PE LNS, and (d) PE + MMN LNS. Analysis of variance examined unadjusted differences in fetal biometry z-scores at 20 and 30 weeks and neonatal anthropometry z-scores, while regression tested for modification of intervention-outcome associations by season and maternal height, body mass index, and weight gain. Despite evidence of between-arm differences in some fetal biometry, z-scores at birth were not greater in the intervention arms than the FeFol arm (e.g., birth weight z-scores: FeFol -0.71, MMN -0.63, PE -0.64, PE + MMN -0.62; group-wise p = .796). In regression analyses, intervention associations with birth weight and head circumference were modified by maternal weight gain between booking and 30 weeks gestation (e.g., PE + MMN associations with birth weight were +0.462 z-scores (95% CI [0.097, 0.826]) in the highest quartile of weight gain but -0.099 z-scores (-0.459, 0.260) in the lowest). In conclusion, we found no strong evidence that a prenatal LNS intervention was associated with better fetal growth in the whole sample. © 2016 The Authors. Maternal & Child Nutrition published by John Wiley & Sons Ltd.

Ultrasonographic measurement of the acromiohumeral distance in spinal cord injury: Reliability and effects of shoulder positioning.

PubMed

Lin, Yen-Sheng; Boninger, Michael L; Day, Kevin A; Koontz, Alicia M

2015-11-01

To investigate the reliability of ultrasonographic measurement of acromiohumeral distance (AHD) and the effects of shoulder positioning on AHD among manual wheelchair users (MWUs) with spinal cord injury (SCI) and an able-bodied control group. Ten MWUs with SCI and 10 able-bodied subjects participated in this study. The ultrasonographic measurements of AHD from each subject were obtained by two raters during passive and active scapular plane arm elevation in neutral, 45°, 90° with and without resistance and in a weight relief raise position. The measurements were recorded again by each rater using the same procedures after a 30-minute time interval. All raters were blinded to each other's measurements. University Laboratories and Veteran Affairs Healthcare System. Intra-rater (intraclass correlation coefficient, ICC > 0.83) and inter-rater (ICC > 0.78) reliability was excellent for both the MWUs with SCI and able-bodied groups across all arm positions except for the 45° position in the control group for one of the raters (intra-rater: ICC < 0.40 and inter-rater: ICC < 0.60). AHD significantly reduced when the shoulder was in the 90° arm elevated positions with or without resistance. Findings from our study demonstrated that ultrasonography is a reliable means to evaluate AHD in both able bodied and individuals with SCI, who are known to have significant shoulder pathology. This technique could be used to develop reference measures and to identify changes in AHD caused by interventions.

Recovery in the Severely Impaired Arm Post-stroke after Mirror Therapy - a Randomized Controlled Study.

PubMed

Chan, Wing Chiu; Au-Yeung, Stephanie Suk Yin

2018-03-09

This study aimed to examine the effectiveness of mirror therapy (MT) on recovery in the severely impaired arm after stroke. Using single-blind randomized controlled design, patients with severely impaired arm within 1-month post-stroke were assigned to received MT (n=20) or control therapy (CT) (n=21), 30min. twice daily for 4 weeks in addition to conventional rehabilitation. During MT and CT, subjects practiced similar structured exercises in both arms, except that mirror reflection of the unaffected arm was the visual feedback for MT, but mirror was absent for CT so that subjects could watch both arms in exercise. Fugl-Meyer Assessment (FMA) and Wolf Motor Function Test (WMFT) were the outcome measurements. After the intervention, both MT and CT groups had significant arm recovery similarly in FMA (p=0.867), WMFT-Time (p=0.947) and WMFT-Functional Ability Scale (p=0.676). MT or CT which involved exercises concurrently for the paretic and unaffected arms during subacute stroke promoted similar motor recovery in the severely impaired arm.

Birefringence insensitive optical coherence domain reflectometry system

DOEpatents

Everett, Matthew J.; Davis, Joseph G.

2002-01-01

A birefringence insensitive fiber optic optical coherence domain reflectometry (OCDR) system is provided containing non-polarization maintaining (non-PM) fiber in the sample arm and the reference arm without suffering from signal degradation caused by birefringence. The use of non-PM fiber significantly reduces the cost of the OCDR system and provides a disposable or multiplexed section of the sample arm. The dispersion in the reference arm and sample arm of the OCDR system are matched to achieve high resolution imaging. This system is useful in medical applications or for non-medical in situ probes. The disposable section of non-PM fiber in the sample arm can be conveniently replaced when contaminated by a sample or a patient.

Moving Events in Time: Time-Referent Hand-Arm Movements Influence Perceived Temporal Distance to Past Events

ERIC Educational Resources Information Center

Blom, Stephanie S. A. H.; Semin, Gun R.

2013-01-01

We examine and find support for the hypothesis that time-referent hand-arm movements influence temporal judgments. In line with the concept of "left is associated with earlier times, and right is associated with later times," we show that performing left (right) hand-arm movements while thinking about a past event increases (decreases) the…

Brief Report: Dolutegravir Plus Abacavir/Lamivudine for the Treatment of HIV-1 Infection in Antiretroviral Therapy-Naive Patients: Week 96 and Week 144 Results From the SINGLE Randomized Clinical Trial.

PubMed

Walmsley, Sharon; Baumgarten, Axel; Berenguer, Juan; Felizarta, Franco; Florence, Eric; Khuong-Josses, Marie-Aude; Kilby, J Michael; Lutz, Thomas; Podzamczer, Daniel; Portilla, Joaquin; Roth, Norman; Wong, Deborah; Granier, Catherine; Wynne, Brian; Pappa, Keith

2015-12-15

The SINGLE study was a randomized, double-blind, noninferiority study that evaluated the safety and efficacy of 50 mg dolutegravir + abacavir/lamivudine versus efavirenz/tenofovir/emtricitabine in 833 ART-naive HIV-1 + participants. Of 833 randomized participants, 71% in the dolutegravir + abacavir/lamivudine arm and 63% in the efavirenz/tenofovir/emtricitabine arm maintained viral loads of <50 copies per milliliter through W144 (P = 0.01). Superior efficacy was primarily driven by fewer discontinuations due to adverse events in the dolutegravir + abacavir/lamivudine arm [dolutegravir + abacavir/lamivudine arm, 16 (4%); efavirenz/tenofovir/emtricitabine arm, 58 (14%)] through W144 [corrected]. No treatment-emergent integrase or nucleoside resistance was observed in dolutegravir + abacavir/lamivudine recipients through W144.

Virtual patients in the acquisition of clinical reasoning skills: does presentation mode matter? A quasi-randomized controlled trial.

PubMed

Schubach, Fabian; Goos, Matthias; Fabry, Götz; Vach, Werner; Boeker, Martin

2017-09-15

The objective of this study is to compare two different instructional methods in the curricular use of computerized virtual patients in undergraduate medical education. We aim to investigate whether using many short and focused cases - the key feature principle - is more effective for the learning of clinical reasoning skills than using few long and systematic cases. We conducted a quasi-randomized, non-blinded, controlled parallel-group intervention trial in a large medical school in Southwestern Germany. During two seminar sessions, fourth- and fifth-year medical students (n = 56) worked on the differential diagnosis of the acute abdomen. The educational tool - virtual patients - was the same, but the instructional method differed: In one trial arm, students worked on multiple short cases, with the instruction being focused only on important elements ("key feature arm", n = 30). In the other trial arm, students worked on few long cases, with the instruction being comprehensive and systematic ("systematic arm", n = 26). The overall training time was the same in both arms. The students' clinical reasoning capacity was measured by a specifically developed instrument, a script concordance test. Their motivation and the perceived effectiveness of the instruction were assessed using a structured evaluation questionnaire. Upon completion of the script concordance test with a reference score of 80 points and a standard deviation of 5 for experts, students in the key feature arm attained a mean of 57.4 points (95% confidence interval: 50.9-63.9), and in the systematic arm, 62.7 points (57.2-68.2), with Cohen's d at 0.337. The difference is statistically non-significant (p = 0.214). In the evaluation survey, students in the key feature arm indicated that they experienced more time pressure and perceived the material as more difficult. In this study powered for a medium effect, we could not provide empirical evidence for the hypothesis that a key feature-based instruction on multiple short cases is superior to a systematic instruction on few long cases in the curricular implementation of virtual patients. The results of the evaluation survey suggest that learners should be given enough time to work through case examples, and that caution should be taken to prevent cognitive overload.

TROPICS 1: a phase III, randomized, double-blind, placebo-controlled study of tenecteplase for restoration of function in dysfunctional central venous catheters.

PubMed

Gabrail, Nashat; Sandler, Eric; Charu, Veena; Anas, Nick; Lim, Eduardo; Blaney, Martha; Ashby, Mark; Gillespie, Barbara S; Begelman, Susan M

2010-12-01

To evaluate the efficacy and safety of the thrombolytic tenecteplase, a fibrin-specific recombinant tissue plasminogen activator, for restoring function to dysfunctional central venous catheters (CVCs). In this double-blind, placebo-controlled study, eligible patients with dysfunctional nonhemodialysis CVCs were randomly assigned to two treatment arms. In the first arm (TNK-TNK-PBO), patients received an initial dose of intraluminal tenecteplase (TNK) (up to 2 mg), a second dose of tenecteplase if indicated, and a third placebo (PBO) dose. In the PBO-TNK-TNK arm, placebo was instilled first followed by up to two doses of tenecteplase, if needed, for restoration of catheter function. After administration of each dose, CVC function was assessed at 15, 30, and 120 minutes. There were 97 patients who received either TNK-TNK-PBO (n = 50) or PBO-TNK-TNK (n = 47). Within 120 minutes of initial study drug instillation, catheter function was restored to 30 patients (60%) in the TNK-TNK-PBO arm and 11 patients (23%) in the PBO-TNK-TNK arm, for a treatment difference of 37 percentage points (95% confidence interval 18-55; P = .0002). Cumulative restoration rates for CVC function increased to 87% after the second dose of tenecteplase in both study arms combined. Two patients developed a deep vein thrombosis (DVT) after exposure to tenecteplase; one DVT was considered to be drug related. No cases of intracranial hemorrhage, major bleeding, embolic events, catheter-related bloodstream infections, or catheter-related complications were reported. Tenecteplase was efficacious for restoration of catheter function in these study patients with dysfunctional CVCs. Copyright © 2010 SIR. Published by Elsevier Inc. All rights reserved.

Genetics Home Reference: X-linked congenital stationary night blindness

MedlinePlus

... Health Conditions X-linked congenital stationary night blindness X-linked congenital stationary night blindness Printable PDF Open ... Javascript to view the expand/collapse boxes. Description X-linked congenital stationary night blindness is a disorder ...

Game Performance Evaluation in Male Goalball Players

PubMed Central

Molik, Bartosz; Morgulec-Adamowicz, Natalia; Kosmol, Andrzej; Perkowski, Krzysztof; Bednarczuk, Grzegorz; Skowroński, Waldemar; Gomez, Miguel Angel; Koc, Krzysztof; Rutkowska, Izabela; Szyman, Robert J

2015-01-01

Goalball is a Paralympic sport exclusively for athletes who are visually impaired and blind. The aims of this study were twofold: to describe game performance of elite male goalball players based upon the degree of visual impairment, and to determine if game performance was related to anthropometric characteristics of elite male goalball players. The study sample consisted of 44 male goalball athletes. A total of 38 games were recorded during the Summer Paralympic Games in London 2012. Observations were reported using the Game Efficiency Sheet for Goalball. Additional anthropometric measurements included body mass (kg), body height (cm), the arm span (cm) and length of the body in the defensive position (cm). The results differentiating both groups showed that the players with total blindness obtained higher means than the players with visual impairment for game indicators such as the sum of defense (p = 0.03) and the sum of good defense (p = 0.04). The players with visual impairment obtained higher results than those with total blindness for attack efficiency (p = 0.04), the sum of penalty defenses (p = 0.01), and fouls (p = 0.01). The study showed that athletes with blindness demonstrated higher game performance in defence. However, athletes with visual impairment presented higher efficiency in offensive actions. The analyses confirmed that body mass, body height, the arm span and length of the body in the defensive position did not differentiate players’ performance at the elite level. PMID:26834872

Blind operation of optical astronomical interferometers options and predicted performance

NASA Astrophysics Data System (ADS)

Beckers, Jacques M.

1991-01-01

Maximum sensitivity for optical interferometers is achieved only when the optical path lengths between the different arms can be equalized without using interference fringes on the research object itself. This is called 'blind operation' of the interferometer. This paper examines different options to achieve this, focusing on the application to the Very Large Telescope Interferometer (VLTI). It is proposed that blind operation should be done using a so-called coherence autoguider, working on an unresolved star of magnitude V = 11-13 within the isoplanatic patch for coherencing, which has a diameter of about 1 deg. Estimates of limiting magnitudes for the VLTI are also derived.

Validity of the Acti4 software using ActiGraph GT3X+accelerometer for recording of arm and upper body inclination in simulated work tasks.

PubMed

Korshøj, Mette; Skotte, Jørgen H; Christiansen, Caroline S; Mortensen, Pelle; Kristiansen, Jesper; Hanisch, Christiana; Ingebrigtsen, Jørgen; Holtermann, Andreas

2014-01-01

The validity of inclinometer measurements by ActiGraph GT3X+ (AG) accelerometer, when analysed with the Acti4 customised software, was examined by comparison of inclinometer measurements with a reference system (TrakStar) in a protocol with standardised arm movements and simulated working tasks. The sensors were placed at the upper arm (distal to the deltoid insertion) and at the spine (level of T1-T2) on eight participants. Root mean square errors (RMSEs) values of inclination between the two systems were low for the slow- and medium-speed standardised arm movements and in simulated working tasks. Fast arm movements caused the inclination estimated by the AG to deviate from the reference measurements (RMSE values up to ∼10°). Furthermore, it was found that AG positioned at the upper arm provided inclination data without bias compared to the reference system. These findings indicate that the AG provides valid estimates of arm and upper body inclination in working participants. Being inexpensive, small, water-resistant and without wires, ActiGraph GT3X+ seems to be a valid mean for direct long-term field measurements of arm and trunk inclinations when analysed by the Acti4 customised software.

The Last Meter: Blind Visual Guidance to a Target.

PubMed

Manduchi, Roberto; Coughlan, James M

2014-01-01

Smartphone apps can use object recognition software to provide information to blind or low vision users about objects in the visual environment. A crucial challenge for these users is aiming the camera properly to take a well-framed picture of the desired target object. We investigate the effects of two fundamental constraints of object recognition - frame rate and camera field of view - on a blind person's ability to use an object recognition smartphone app. The app was used by 18 blind participants to find visual targets beyond arm's reach and approach them to within 30 cm. While we expected that a faster frame rate or wider camera field of view should always improve search performance, our experimental results show that in many cases increasing the field of view does not help, and may even hurt, performance. These results have important implications for the design of object recognition systems for blind users.

Aprepitant as an add-on therapy in children receiving highly emetogenic chemotherapy: a randomized, double-blind, placebo-controlled trial.

PubMed

Bakhshi, Sameer; Batra, Atul; Biswas, Bivas; Dhawan, Deepa; Paul, Reeja; Sreenivas, Vishnubhatla

2015-11-01

Aprepitant, a neurokinin-1 receptor antagonist, in combination with 5 HT-3 antagonist and dexamethasone is recommended in adults receiving moderately and highly emetogenic chemotherapy to reduce chemotherapy-induced vomiting (CIV). Data for use of aprepitant in children is limited and hence aprepitant is not recommended by Pediatric Oncology Group of Ontario guidelines for prevention of CIV in children <12 years. A randomized, double-blind, placebo-controlled trial was conducted at a single center in chemotherapy naïve children (5-18 years) receiving highly emetogenic chemotherapy. All patients received intravenous ondansetron (0.15 mg/kg) and dexamethasone (0.15 mg/kg) prior to chemotherapy followed by oral ondansetron and dexamethasone. Patients randomly assigned to aprepitant arm received oral aprepitant (15-40 kg = days 1-3, 80 mg; 41-65 kg = day 1, 125 mg and days 2-3, 80 mg) 1 h before chemotherapy. Control group received placebo as add-on therapy. Primary outcome measure was the incidence of acute moderate to severe vomiting, which was defined as more than two vomiting episodes within 24 h after the administration of the first chemotherapy dose until 24 h after the last chemotherapy dose in the block. Complete response (CR) was defined as absence of vomiting and retching during the specified phase. Of the 96 randomized patients, three were excluded from analysis; 93 patients were analyzed (50 in aprepitant arm and 43 in placebo arm). Acute moderate and severe vomiting was reported in 72 % patients receiving placebo and 38 % patients receiving aprepitant (p = 0.001). Complete response rates during acute phase were significantly higher in aprepitant arm (48 vs. 12 %, p < 0.001). No major adverse effects were reported by patients/guardians. This double-blind, randomized, placebo-controlled trial shows that aprepitant significantly decreases the incidence of CIV during acute phase when used as an add-on drug with ondansetron and dexamethasone in children receiving highly emetogenic chemotherapy.

Ultrasonographic measurement of the acromiohumeral distance in spinal cord injury: Reliability and effects of shoulder positioning

PubMed Central

Lin, Yen-Sheng; Boninger, Michael L.; Day, Kevin A.

2015-01-01

Objective To investigate the reliability of ultrasonographic measurement of acromiohumeral distance (AHD) and the effects of shoulder positioning on AHD among manual wheelchair users (MWUs) with spinal cord injury (SCI) and an able-bodied control group. Methods Ten MWUs with SCI and 10 able-bodied subjects participated in this study. The ultrasonographic measurements of AHD from each subject were obtained by two raters during passive and active scapular plane arm elevation in neutral, 45°, 90° with and without resistance and in a weight relief raise position. The measurements were recorded again by each rater using the same procedures after a 30-minute time interval. All raters were blinded to each other's measurements. Setting University Laboratories and Veteran Affairs Healthcare System. Results Intra-rater (intraclass correlation coefficient, ICC > 0.83) and inter-rater (ICC > 0.78) reliability was excellent for both the MWUs with SCI and able-bodied groups across all arm positions except for the 45° position in the control group for one of the raters (intra-rater: ICC < 0.40 and inter-rater: ICC < 0.60). AHD significantly reduced when the shoulder was in the 90° arm elevated positions with or without resistance. Conclusion Findings from our study demonstrated that ultrasonography is a reliable means to evaluate AHD in both able bodied and individuals with SCI, who are known to have significant shoulder pathology. This technique could be used to develop reference measures and to identify changes in AHD caused by interventions. PMID:24968117

Double-Blind Comparison of Phlebitis Produced by Cefazolin Versus Cephalothin

PubMed Central

Shemonsky, Natalie K.; Carrizosa, Jaime; Kaye, Donald; Levison, Matthew E.

1975-01-01

In a double-blind study with each patient as his own control, 1 g of cefazolin and 2 g of cephalothin were administered intravenously every 6 h to 20 patients in opposite arms for a period of 48 h each. The degree of phlebitis was significantly more severe with cephalothin than with cefazolin (P < 0.05); however, neither the incidence of phlebitis nor the time of onset of phlebitis was significantly different between the two drugs. PMID:1147583

Proprioceptive Interaction between the Two Arms in a Single-Arm Pointing Task.

PubMed

Kigawa, Kazuyoshi; Izumizaki, Masahiko; Tsukada, Setsuro; Hakuta, Naoyuki

2015-01-01

Proprioceptive signals coming from both arms are used to determine the perceived position of one arm in a two-arm matching task. Here, we examined whether the perceived position of one arm is affected by proprioceptive signals from the other arm in a one-arm pointing task in which participants specified the perceived position of an unseen reference arm with an indicator paddle. Both arms were hidden from the participant's view throughout the study. In Experiment 1, with both arms placed in front of the body, the participants received 70-80 Hz vibration to the elbow flexors of the reference arm (= right arm) to induce the illusion of elbow extension. This extension illusion was compared with that when the left arm elbow flexors were vibrated or not. The degree of the vibration-induced extension illusion of the right arm was reduced in the presence of left arm vibration. In Experiment 2, we found that this kinesthetic interaction between the two arms did not occur when the left arm was vibrated in an abducted position. In Experiment 3, the vibration-induced extension illusion of one arm was fully developed when this arm was placed at an abducted position, indicating that the brain receives increased proprioceptive input from a vibrated arm even if the arm was abducted. Our results suggest that proprioceptive interaction between the two arms occurs in a one-arm pointing task when the two arms are aligned with one another. The position sense of one arm measured using a pointer appears to include the influences of incoming information from the other arm when both arms were placed in front of the body and parallel to one another.

Proprioceptive Interaction between the Two Arms in a Single-Arm Pointing Task

PubMed Central

Kigawa, Kazuyoshi; Izumizaki, Masahiko; Tsukada, Setsuro; Hakuta, Naoyuki

2015-01-01

Proprioceptive signals coming from both arms are used to determine the perceived position of one arm in a two-arm matching task. Here, we examined whether the perceived position of one arm is affected by proprioceptive signals from the other arm in a one-arm pointing task in which participants specified the perceived position of an unseen reference arm with an indicator paddle. Both arms were hidden from the participant’s view throughout the study. In Experiment 1, with both arms placed in front of the body, the participants received 70–80 Hz vibration to the elbow flexors of the reference arm (= right arm) to induce the illusion of elbow extension. This extension illusion was compared with that when the left arm elbow flexors were vibrated or not. The degree of the vibration-induced extension illusion of the right arm was reduced in the presence of left arm vibration. In Experiment 2, we found that this kinesthetic interaction between the two arms did not occur when the left arm was vibrated in an abducted position. In Experiment 3, the vibration-induced extension illusion of one arm was fully developed when this arm was placed at an abducted position, indicating that the brain receives increased proprioceptive input from a vibrated arm even if the arm was abducted. Our results suggest that proprioceptive interaction between the two arms occurs in a one-arm pointing task when the two arms are aligned with one another. The position sense of one arm measured using a pointer appears to include the influences of incoming information from the other arm when both arms were placed in front of the body and parallel to one another. PMID:26317518

Effects of telephone-delivered lifestyle support on the development of diabetes in participants at high risk of type 2 diabetes: J-DOIT1, a pragmatic cluster randomised trial.

PubMed

Sakane, Naoki; Kotani, Kazuhiko; Takahashi, Kaoru; Sano, Yoshiko; Tsuzaki, Kokoro; Okazaki, Kentaro; Sato, Juichi; Suzuki, Sadao; Morita, Satoshi; Oshima, Yoshitake; Izumi, Kazuo; Kato, Masayuki; Ishizuka, Naoki; Noda, Mitsuhiko; Kuzuya, Hideshi

2015-08-19

To examine the effects of telephone-delivered lifestyle coaching on preventing the development of type 2 diabetes mellitus (T2DM) in participants with impaired fasting glucose (IFG). Cluster randomised trial. 40 groups from 17 healthcare divisions in Japan: companies (31), communities (6) and mixed settings (3). Participants aged 20-65 years with fasting plasma glucose (FPG) of 5.6-6.9 mmol/L were invited from the 17 healthcare divisions. The groups were then randomly assigned to an intervention or a control arm by independent statisticians according to a computer-generated list. The intervention arm received a 1-year telephone-delivered intervention provided by three private lifestyle support centres (at different frequencies: low-frequency (3 times), middle-frequency (6 times) and high-frequency (10 times) support calls). The intervention and control arms both received self-help devices such as a weight scale and pedometer. Participants were followed up using data from annual health check-ups and a questionnaire regarding lifestyle. The primary outcome was the development of T2DM defined as FPG ≥ 7.0 mmol/L, the diagnosis of diabetes, or use of an antidiabetic drug, confirmed by referring to medical cards. Of 14,473 screened individuals, participants were enrolled in either the intervention (n = 1240) arm or control (n = 1367) arm. Overall, the HR for the development of T2DM in the intervention arm during 5.5 years was 1.00 (95% CI 0.74 to 1.34). In the subanalysis, the HR was 0.59 (95% CI 0.42 to 0.83) in the subgroup that received phone calls the most frequently, compared with the control arm. A limitation of the study includes a lack of blinding. High-frequency telephone-delivered lifestyle support could effectively prevent T2DM in participants with IFG in a primary healthcare setting, although low-frequency and middle-frequency phone calls did not. This trial has been registered with the University Hospital Medical Information Network (UMIN000000662). 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.

L-carnitine supplementation in patients with HIV/AIDS and fatigue: a double-blind, placebo-controlled pilot study.

PubMed

Cruciani, Ricardo A; Revuelta, Manuel; Dvorkin, Ella; Homel, Peter; Lesage, Pauline; Esteban-Cruciani, Nora

2015-01-01

The purpose of this study was to determine the effect of L-carnitine supplementation on fatigue in patients with terminal human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS). In this randomized, double-blind, placebo-controlled, parallel-group study, patients who had end-stage HIV/AIDS with carnitine deficiency and fatigue received 3 g of oral L-carnitine or placebo for 2 weeks, followed by a 2-week, open-label phase with the same amount of L-carnitine for all patients. The primary outcome was the degree of fatigue according to the Brief Fatigue Inventory. Secondary outcomes included serum carnitine and lactate levels, physical, emotional, social, and functional well-being, performance status, mood, and CD4 count. Eighteen patients in the treatment arm and 17 in the placebo arm completed the trial. At the end of the double-blind phase, total and free carnitine levels in the treatment arm rose from 28±9 to 48±17 nM/L (P<0.001) and from 24±8 to 40±13 nM/L (P<0.001) respectively, with no changes in the placebo arm. The primary outcome, ie, fatigue measured at the end of the blinded phase, did not improve. Secondary outcomes of function, quality of life, and mood did not show improvement either. The secondary outcome of serum lactate decreased from baseline in the treatment group (1.45±0.76 to 1.28±0.52 mmol/L) and increased in the placebo group (1.38±0.62 to 1.84±0.74 mmol/L; P<0.005). Our study suggests that 3 g of oral L-carnitine supplementation for 2 weeks in terminally ill HIV/AIDS patients does not improve fatigue. This study might help to determine the dose and duration of treatment used in future clinical trials, as higher doses and/or longer periods of supplementation might be needed in order to detect an improvement. The reduction in serum lactate levels suggests a potential role for L-carnitine supplementation in patients undergoing certain types of antiretroviral therapy. This study contributes evidence-based data to the field of alternative and complementary medicine, a multibillion dollar industry in which controlled studies are not the norm.

L-carnitine supplementation in patients with HIV/AIDS and fatigue: a double-blind, placebo-controlled pilot study

PubMed Central

Cruciani, Ricardo A; Revuelta, Manuel; Dvorkin, Ella; Homel, Peter; Lesage, Pauline; Esteban-Cruciani, Nora

2015-01-01

Background The purpose of this study was to determine the effect of L-carnitine supplementation on fatigue in patients with terminal human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS). Methods In this randomized, double-blind, placebo-controlled, parallel-group study, patients who had end-stage HIV/AIDS with carnitine deficiency and fatigue received 3 g of oral L-carnitine or placebo for 2 weeks, followed by a 2-week, open-label phase with the same amount of L-carnitine for all patients. The primary outcome was the degree of fatigue according to the Brief Fatigue Inventory. Secondary outcomes included serum carnitine and lactate levels, physical, emotional, social, and functional well-being, performance status, mood, and CD4 count. Results Eighteen patients in the treatment arm and 17 in the placebo arm completed the trial. At the end of the double-blind phase, total and free carnitine levels in the treatment arm rose from 28±9 to 48±17 nM/L (P<0.001) and from 24±8 to 40±13 nM/L (P<0.001) respectively, with no changes in the placebo arm. The primary outcome, ie, fatigue measured at the end of the blinded phase, did not improve. Secondary outcomes of function, quality of life, and mood did not show improvement either. The secondary outcome of serum lactate decreased from baseline in the treatment group (1.45±0.76 to 1.28±0.52 mmol/L) and increased in the placebo group (1.38±0.62 to 1.84±0.74 mmol/L; P<0.005). Conclusion Our study suggests that 3 g of oral L-carnitine supplementation for 2 weeks in terminally ill HIV/AIDS patients does not improve fatigue. This study might help to determine the dose and duration of treatment used in future clinical trials, as higher doses and/or longer periods of supplementation might be needed in order to detect an improvement. The reduction in serum lactate levels suggests a potential role for L-carnitine supplementation in patients undergoing certain types of antiretroviral therapy. This study contributes evidence-based data to the field of alternative and complementary medicine, a multibillion dollar industry in which controlled studies are not the norm. PMID:25733927

Prefrontal Cortical GABA Modulation of Spatial Reference and Working Memory

PubMed Central

Auger, Meagan L.

2015-01-01

Background: Dysfunction in prefrontal cortex (PFC) GABA transmission has been proposed to contribute to cognitive dysfunction in schizophrenia, yet how this system regulates different cognitive and mnemonic functions remains unclear. Methods: We assessed the effects of pharmacological reduction of GABAA signaling in the medial PFC of rats on spatial reference/working memory using different versions of the radial-arm maze task. We used a massed-trials procedure to probe how PFC GABA regulates susceptibility to proactive interference. Male rats were well-trained to retrieve food from the same 4 arms of an 8-arm maze, receiving 5 trials/day (1–2min intervals). Results: Infusions of the GABAA receptor antagonist bicuculline (12.5–50ng) markedly increased working and reference memory errors and response latencies. Similar treatments also impaired short-term memory on an 8-baited arm task. These effects did not appear to be due to increased susceptibility to proactive interference. In contrast, PFC inactivation via infusion of GABA agonists baclofen/muscimol did not affect reference/working memory. In comparison to the pronounced effects on the 8-arm maze tasks, PFC GABAA antagonism only causes a slight and transient decrease in accuracy on a 2-arm spatial discrimination. Conclusions: These findings demonstrate that prefrontal GABA hypofunction severely disrupts spatial reference and short-term memory and that disinhibition of the PFC can, in some instances, perturb memory processes not normally dependent on the frontal lobes. Moreover, these impairments closely resemble those observed in schizophrenic patients, suggesting that perturbation in PFC GABA signaling may contribute to these types of cognitive deficits associated with the disorder. PMID:25552433

Effects of repetitive transcranial magnetic stimulation combined with sensory cueing on unilateral neglect in subacute patients with right hemispheric stroke: a randomized controlled study.

PubMed

Yang, Nicole Yh; Fong, Kenneth Nk; Li-Tsang, Cecilia Wp; Zhou, D

2017-09-01

To compare the effects of rTMS combined with sensory cueing, rTMS alone, and conventional rehabilitation on unilateral neglect, hemiplegic arm functions and performance of activities of daily living. A single-blinded randomized controlled trial. A convalescent hospital. Sixty inpatients with left unilateral neglect after stroke. Patients were randomly assigned to three groups: rTMS combined with sensory cueing, rTMS, and conventional rehabilitation alone. rTMS at 1 Hz was applied over P5 of the contralesional hemisphere while vibration cueing was emitted using a wristwatch device on the hemiplegic arm, five days per week for two weeks. The first two groups received the same dosage of conventional rehabilitation on top of their experimental interventions. Blinded assessments were administered at baseline, 2 weeks postintervention, and 6 weeks follow-up. Neglect and arm motor performance. Both rTMS combined with sensory cueing (99.6±33.0) and rTMS alone (88.2±28.7) significantly reduced unilateral neglect than conventional rehabilitation (72.7±33.1) when measured using the conventional subtests of the Behavioural Inattention Test, but the combination was better than rTMS alone. Hemiplegic arm functions and activities of daily living improved in all patients across the three groups but no significant differences were found between the groups. The combination of inhibitory P5-rTMS with sensory cueing was better than either rTMS or conventional rehabilitation alone in producing a stronger and long-lasting improvement in unilateral neglect, but the improvement was not associated with improved arm function or independence in activities of daily living.

Quality assessment for color reproduction using a blind metric

NASA Astrophysics Data System (ADS)

Bringier, B.; Quintard, L.; Larabi, M.-C.

2007-01-01

This paper deals with image quality assessment. This field plays nowadays an important role in various image processing applications. Number of objective image quality metrics, that correlate or not, with the subjective quality have been developed during the last decade. Two categories of metrics can be distinguished, the first with full-reference and the second with no-reference. Full-reference metric tries to evaluate the distortion introduced to an image with regards to the reference. No-reference approach attempts to model the judgment of image quality in a blind way. Unfortunately, the universal image quality model is not on the horizon and empirical models established on psychophysical experimentation are generally used. In this paper, we focus only on the second category to evaluate the quality of color reproduction where a blind metric, based on human visual system modeling is introduced. The objective results are validated by single-media and cross-media subjective tests.

The effect of arm support combined with rehabilitation games on upper-extremity function in subacute stroke: a randomized controlled trial.

PubMed

Prange, Gerdienke B; Kottink, Anke I R; Buurke, Jaap H; Eckhardt, Martine M E M; van Keulen-Rouweler, Bianca J; Ribbers, Gerard M; Rietman, Johan S

2015-02-01

Use of rehabilitation technology, such as (electro)mechanical devices or robotics, could partly relieve the increasing strain on stroke rehabilitation caused by an increasing prevalence of stroke. Arm support (AS) training showed improvement of unsupported arm function in chronic stroke. To examine the effect of weight-supported arm training combined with computerized exercises on arm function and capacity, compared with dose-matched conventional reach training in subacute stroke patients. In a single-blind, multicenter, randomized controlled trial, 70 subacute stroke patients received 6 weeks of training with either an AS device combined with computerized exercises or dose-matched conventional training (CON). Arm function was evaluated pretraining and posttraining by Fugl-Meyer assessment (FM), maximal reach distance, Stroke Upper Limb Capacity Scale (SULCS), and arm pain via Visual Analogue Scale, in addition to perceived motivation by Intrinsic Motivation Inventory posttraining. FM and SULCS scores and reach distance improved significantly within both groups. These improvements and experienced pain did not differ between groups. The AS group reported higher interest/enjoyment during training than the CON group. AS training with computerized exercises is as effective as conventional therapy dedicated to the arm to improve arm function and activity in subacute stroke rehabilitation, when applied at the same dose. © The Author(s) 2014.

Randomized, Double-Blind, Phase III Trial of Ipilimumab Versus Placebo in Asymptomatic or Minimally Symptomatic Patients With Metastatic Chemotherapy-Naive Castration-Resistant Prostate Cancer.

PubMed

Beer, Tomasz M; Kwon, Eugene D; Drake, Charles G; Fizazi, Karim; Logothetis, Christopher; Gravis, Gwenaelle; Ganju, Vinod; Polikoff, Jonathan; Saad, Fred; Humanski, Piotr; Piulats, Josep M; Gonzalez Mella, Pablo; Ng, Siobhan S; Jaeger, Dirk; Parnis, Francis X; Franke, Fabio A; Puente, Javier; Carvajal, Roman; Sengeløv, Lisa; McHenry, M Brent; Varma, Arvind; van den Eertwegh, Alfonsus J; Gerritsen, Winald

2017-01-01

Purpose Ipilimumab increases antitumor T-cell responses by binding to cytotoxic T-lymphocyte antigen 4. We evaluated treatment with ipilimumab in asymptomatic or minimally symptomatic patients with chemotherapy-naive metastatic castration-resistant prostate cancer without visceral metastases. Patients and Methods In this multicenter, double-blind, phase III trial, patients were randomly assigned (2:1) to ipilimumab 10 mg/kg or placebo every 3 weeks for up to four doses. Ipilimumab 10 mg/kg or placebo maintenance therapy was administered to nonprogressing patients every 3 months. The primary end point was overall survival (OS). Results Four hundred patients were randomly assigned to ipilimumab and 202 to placebo; 399 were treated with ipilimumab and 199 with placebo. Median OS was 28.7 months (95% CI, 24.5 to 32.5 months) in the ipilimumab arm versus 29.7 months (95% CI, 26.1 to 34.2 months) in the placebo arm (hazard ratio, 1.11; 95.87% CI, 0.88 to 1.39; P = .3667). Median progression-free survival was 5.6 months in the ipilimumab arm versus 3.8 with placebo arm (hazard ratio, 0.67; 95.87% CI, 0.55 to 0.81). Exploratory analyses showed a higher prostate-specific antigen response rate with ipilimumab (23%) than with placebo (8%). Diarrhea (15%) was the only grade 3 to 4 treatment-related adverse event (AE) reported in ≥ 10% of ipilimumab-treated patients. Nine (2%) deaths occurred in the ipilimumab arm due to treatment-related AEs; no deaths occurred in the placebo arm. Immune-related grade 3 to 4 AEs occurred in 31% and 2% of patients, respectively. Conclusion Ipilimumab did not improve OS in patients with metastatic castration-resistant prostate cancer. The observed increases in progression-free survival and prostate-specific antigen response rates suggest antitumor activity in a patient subset.

CArbon dioxide surgical field flooding and aortic NO-touch off-pump coronary artery bypass grafting to reduce Neurological injuries after surgical coronary revascularisation (CANON): protocol for a randomised, controlled, investigator and patient blinded single-centre superiority trial with three parallel arms.

PubMed

Krzysztof, Szwed; Wojciech, Pawliszak; Zbigniew, Serafin; Mariusz, Kowalewski; Remigiusz, Tomczyk; Damian, Perlinski; Magdalena, Szwed; Marta, Tomaszewska; Lech, Anisimowicz; Alina, Borkowska

2017-07-10

Neurological injuries remain a major concern following coronary artery bypass grafting (CABG) that offsets survival benefit of CABG over percutaneous coronary interventions. Among numerous efforts to combat this issue is the development of off-pump CABG (OPCABG) that obviates the need for extracorporeal circulation and is associated with improved neurological outcomes. The objective of this study is to examine whether the neuroprotective effect of OPCABG can be further pronounced by the use of two state-of-the-art operating techniques. In this randomised, controlled, investigator and patient blinded single-centre superiority trial with three parallel arms, a total of 360 patients will be recruited. They will be allocated in a 1:1:1 ratio to two treatment arms and one control arm. Treatment arms undergoing either aortic no-touch OPCABG or OPCABG with partial clamp applying carbon dioxide surgical field flooding will be compared against control arm undergoing OPCABG with partial clamp. The primary endpoint will be the appearance of new lesions on control brain MRI 3 days after surgery. Secondary endpoints will include the prevalence of new focal neurological deficits in the first 7 days after surgery, the occurrence of postoperative cognitive dysfunction at either 1 week or 3 months after surgery and the incidence of delirium in the first 7 days after surgery. Data will be analysed on intention-to-treat principles and a per protocol basis. Ethical approval has been granted for this study. Results will be disseminated through peer-reviewed media. NCT03074604; Pre-results. 10-Mar-2017 Original. © 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.

[Rudolph Tegner: The blind from Marrakech (1949-1950)].

PubMed

Norn, M; Permin, H

1999-01-01

The Danish sculptor and painter Rudolph Tegner (1873-1950) has built his own Museum in Dronningmolle, where his sculptures enrich the unique landscape. His last and incomplete plaster on a simple, raw wooden scaffold sculpture The Blind from Marrakech (Fig. 1) show five persons moan about, carrying a dead body. All persons are missing their arms. Tegner had a number of years earlier been in Marrakech and had watched a funeral procession, where blind beggars had carried a dead old woman raised high above the bearers on a kind of pall. In a small version of the statue cast, later in bronze from 1963, showed 15 bearers, on both sides of the bier (Fig. 2 & 3). Nine and 15 bearers are looking up, two right in front, and the rest are looking down. Totally blind people can not see the light but can see up to the divine Heaven. Some blind have kept the gleam. The confusion with the eye direction shows that they really are blind. However 10 of the 15 blind people had hollow in the eye (excenteratio orbitae) in contrast to the dead woman. The dead woman had been the blinds' mistress. The last work The Blind in Marrakech may also be the despair of the artist.

76 FR 33999 - Spouse and Surviving Spouse; Technical Amendment

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-10

... procedure, Aged, Authority delegations, Blind, Buildings, Civil rights, Employment, Equal educational... Administrative practice and procedure, Armed forces, Civil rights, Claims, Colleges and universities, Conflict of...-ASSISTED PROGRAMS OF THE DEPARTMENT OF VETERANS AFFAIRS--EFFECTUATION OF TITLE VI OF THE CIVIL RIGHTS ACT...

20 CFR 416.934 - Impairments which may warrant a finding of presumptive disability or presumptive blindness.

Code of Federal Regulations, 2012 CFR

2012-04-01

...) Allegation of a stroke (cerebral vascular accident) more than 3 months in the past and continued marked difficulty in walking or using a hand or arm; (f) Allegation of cerebral palsy, muscular dystrophy or muscle...

20 CFR 416.934 - Impairments which may warrant a finding of presumptive disability or presumptive blindness.

Code of Federal Regulations, 2013 CFR

2013-04-01

...) Allegation of a stroke (cerebral vascular accident) more than 3 months in the past and continued marked difficulty in walking or using a hand or arm; (f) Allegation of cerebral palsy, muscular dystrophy or muscle...

20 CFR 416.934 - Impairments which may warrant a finding of presumptive disability or presumptive blindness.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) Allegation of a stroke (cerebral vascular accident) more than 3 months in the past and continued marked difficulty in walking or using a hand or arm; (f) Allegation of cerebral palsy, muscular dystrophy or muscle...

20 CFR 416.934 - Impairments which may warrant a finding of presumptive disability or presumptive blindness.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) Allegation of a stroke (cerebral vascular accident) more than 3 months in the past and continued marked difficulty in walking or using a hand or arm; (f) Allegation of cerebral palsy, muscular dystrophy or muscle...

An elevated plus-maze in mixed reality for studying human anxiety-related behavior.

PubMed

Biedermann, Sarah V; Biedermann, Daniel G; Wenzlaff, Frederike; Kurjak, Tim; Nouri, Sawis; Auer, Matthias K; Wiedemann, Klaus; Briken, Peer; Haaker, Jan; Lonsdorf, Tina B; Fuss, Johannes

2017-12-21

A dearth of laboratory tests to study actual human approach-avoidance behavior has complicated translational research on anxiety. The elevated plus-maze (EPM) is the gold standard to assess approach-avoidance behavior in rodents. Here, we translated the EPM to humans using mixed reality through a combination of virtual and real-world elements. In two validation studies, we observed participants' anxiety on a behavioral, physiological, and subjective level. Participants reported higher anxiety on open arms, avoided open arms, and showed an activation of endogenous stress systems. Participants' with high anxiety exhibited higher avoidance. Moreover, open arm avoidance was moderately predicted by participants' acrophobia and sensation seeking, with opposing influences. In a randomized, double blind, placebo controlled experiment, GABAergic stimulation decreased avoidance of open arms while alpha-2-adrenergic antagonism increased avoidance. These findings demonstrate cross-species validity of open arm avoidance as a translational measure of anxiety. We thus introduce the first ecologically valid assay to track actual human approach-avoidance behavior under laboratory conditions.

Blinded sample size re-estimation in three-arm trials with 'gold standard' design.

PubMed

Mütze, Tobias; Friede, Tim

2017-10-15

In this article, we study blinded sample size re-estimation in the 'gold standard' design with internal pilot study for normally distributed outcomes. The 'gold standard' design is a three-arm clinical trial design that includes an active and a placebo control in addition to an experimental treatment. We focus on the absolute margin approach to hypothesis testing in three-arm trials at which the non-inferiority of the experimental treatment and the assay sensitivity are assessed by pairwise comparisons. We compare several blinded sample size re-estimation procedures in a simulation study assessing operating characteristics including power and type I error. We find that sample size re-estimation based on the popular one-sample variance estimator results in overpowered trials. Moreover, sample size re-estimation based on unbiased variance estimators such as the Xing-Ganju variance estimator results in underpowered trials, as it is expected because an overestimation of the variance and thus the sample size is in general required for the re-estimation procedure to eventually meet the target power. To overcome this problem, we propose an inflation factor for the sample size re-estimation with the Xing-Ganju variance estimator and show that this approach results in adequately powered trials. Because of favorable features of the Xing-Ganju variance estimator such as unbiasedness and a distribution independent of the group means, the inflation factor does not depend on the nuisance parameter and, therefore, can be calculated prior to a trial. Moreover, we prove that the sample size re-estimation based on the Xing-Ganju variance estimator does not bias the effect estimate. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

Prefrontal cortical GABA modulation of spatial reference and working memory.

PubMed

Auger, Meagan L; Floresco, Stan B

2014-10-31

Dysfunction in prefrontal cortex (PFC) GABA transmission has been proposed to contribute to cognitive dysfunction in schizophrenia, yet how this system regulates different cognitive and mnemonic functions remains unclear. We assessed the effects of pharmacological reduction of GABAA signaling in the medial PFC of rats on spatial reference/working memory using different versions of the radial-arm maze task. We used a massed-trials procedure to probe how PFC GABA regulates susceptibility to proactive interference. Male rats were well-trained to retrieve food from the same 4 arms of an 8-arm maze, receiving 5 trials/day (1-2 min intervals). Infusions of the GABAA receptor antagonist bicuculline (12.5-50 ng) markedly increased working and reference memory errors and response latencies. Similar treatments also impaired short-term memory on an 8-baited arm task. These effects did not appear to be due to increased susceptibility to proactive interference. In contrast, PFC inactivation via infusion of GABA agonists baclofen/muscimol did not affect reference/working memory. In comparison to the pronounced effects on the 8-arm maze tasks, PFC GABAA antagonism only causes a slight and transient decrease in accuracy on a 2-arm spatial discrimination. These findings demonstrate that prefrontal GABA hypofunction severely disrupts spatial reference and short-term memory and that disinhibition of the PFC can, in some instances, perturb memory processes not normally dependent on the frontal lobes. Moreover, these impairments closely resemble those observed in schizophrenic patients, suggesting that perturbation in PFC GABA signaling may contribute to these types of cognitive deficits associated with the disorder. © The Author 2014. Published by Oxford University Press on behalf of CINP.

Hyperbaric Oxygen Therapy in the Treatment of Chronic Mild-Moderate Blast-Induced Traumatic Brain Injury Post-Concussion Syndrome (PCS) and Post Traumatic Stress Disorder (PTSD)

DTIC Science & Technology

2017-10-01

a randomized sham- controlled double-blind design with the sham- control group receiving slightly pressurized air at the beginning and end of each... controlled ( non -treatment, non -sham) single-arm crossover single-blind study. The scope of the project is to recruit, enroll, test, treat, re-test and...the P.I. conducted a non - controlled pilot trial of hyperbaric oxygen therapy (HBOT 1.5 atmospheres absolute/60 minutes, twice/day, 40 treatments

A randomized trial of 7-day doripenem versus 10-day imipenem-cilastatin for ventilator-associated pneumonia.

PubMed

Kollef, Marin H; Chastre, Jean; Clavel, Marc; Restrepo, Marcos I; Michiels, Bart; Kaniga, Koné; Cirillo, Iolanda; Kimko, Holly; Redman, Rebecca

2012-11-13

The aim of this study was to compare a 7-day course of doripenem to a 10-day course of imipenem-cilastatin for ventilator-associated pneumonia (VAP) due to Gram-negative bacteria. This was a prospective, double-blinded, randomized trial comparing a fixed 7-day course of doripenem one gram as a four-hour infusion every eight hours with a fixed 10-day course of imipenem-cilastatin one gram as a one-hour infusion every eight hours (April 2008 through June 2011). The study was stopped prematurely at the recommendation of the Independent Data Monitoring Committee that was blinded to treatment arm assignment and performed a scheduled review of data which showed signals that were close to the pre-specified stopping limits. The final analyses included 274 randomized patients. The clinical cure rate at the end of therapy (EOT) in the microbiological intent-to-treat (MITT) population was numerically lower for patients in the doripenem arm compared to the imipenem-cilastatin arm (45.6% versus 56.8%; 95% CI, -26.3% to 3.8%). Similarly, the clinical cure rate at EOT was numerically lower for patients with Pseudomonas aeruginosa VAP, the most common Gram-negative pathogen, in the doripenem arm compared to the imipenem-cilastatin arm (41.2% versus 60.0%; 95% CI, -57.2 to 19.5). All cause 28-day mortality in the MITT group was numerically greater for patients in the doripenem arm compared to the imipenem-cilastatin arm (21.5% versus 14.8%; 95% CI, -5.0 to 18.5) and for patients with P. aeruginosa VAP (35.3% versus 0.0%; 95% CI, 12.6 to 58.0). Among patients with microbiologically confirmed late-onset VAP, a fixed 7-day course of doripenem was found to have non-significant higher rates of clinical failure and mortality compared to a fixed 10-day course of imipenem-cilastatin. Consideration should be given to treating patients with VAP for more than seven days to optimize clinical outcome. ClinicalTrials.gov: NCT00589693.

A randomized trial of 7-day doripenem versus 10-day imipenem-cilastatin for ventilator-associated pneumonia

PubMed Central

2012-01-01

Introduction The aim of this study was to compare a 7-day course of doripenem to a 10-day course of imipenem-cilastatin for ventilator-associated pneumonia (VAP) due to Gram-negative bacteria. Methods This was a prospective, double-blinded, randomized trial comparing a fixed 7-day course of doripenem one gram as a four-hour infusion every eight hours with a fixed 10-day course of imipenem-cilastatin one gram as a one-hour infusion every eight hours (April 2008 through June 2011). Results The study was stopped prematurely at the recommendation of the Independent Data Monitoring Committee that was blinded to treatment arm assignment and performed a scheduled review of data which showed signals that were close to the pre-specified stopping limits. The final analyses included 274 randomized patients. The clinical cure rate at the end of therapy (EOT) in the microbiological intent-to-treat (MITT) population was numerically lower for patients in the doripenem arm compared to the imipenem-cilastatin arm (45.6% versus 56.8%; 95% CI, -26.3% to 3.8%). Similarly, the clinical cure rate at EOT was numerically lower for patients with Pseudomonas aeruginosa VAP, the most common Gram-negative pathogen, in the doripenem arm compared to the imipenem-cilastatin arm (41.2% versus 60.0%; 95% CI, -57.2 to 19.5). All cause 28-day mortality in the MITT group was numerically greater for patients in the doripenem arm compared to the imipenem-cilastatin arm (21.5% versus 14.8%; 95% CI, -5.0 to 18.5) and for patients with P. aeruginosa VAP (35.3% versus 0.0%; 95% CI, 12.6 to 58.0). Conclusions Among patients with microbiologically confirmed late-onset VAP, a fixed 7-day course of doripenem was found to have non-significant higher rates of clinical failure and mortality compared to a fixed 10-day course of imipenem-cilastatin. Consideration should be given to treating patients with VAP for more than seven days to optimize clinical outcome. Trial Registration ClinicalTrials.gov: NCT00589693 PMID:23148736

Comparison of lorazepam and zopiclone for insomnia in patients with stroke and brain injury: a randomized, crossover, double-blinded trial.

PubMed

Li Pi Shan, Rodney S; Ashworth, Nigel L

2004-06-01

To determine if lorazepam or zopiclone is more effective in providing a restful night of sleep and to assess the effects of these medications on cognition. A randomized, double-blinded, crossover trial was performed at a tertiary care rehabilitation inpatient unit in a teaching hospital. A total of 18 brain-injured and stroke patients, aged 20-78 yrs, were administered lorazepam, 0.5-1.0 mg, orally at bedtime as needed for 7 days and zopiclone, 3.75-7.5 mg, orally at bedtime as needed for 7 days. Total sleep time and characteristics of sleep were measured. Effects on cognition were also measured using the Folstein Mini Mental Status Exam. There was no difference in average sleep duration or in subjective measures of sleep. Cognition as assessed by the Mini Mental Status Exam revealed no difference in the zopiclone arm compared with the lorazepam arm. Zopiclone is equally effective as lorazepam in the treatment of insomnia in stroke and brain-injured patients.

A Literature Review of Inattentional and Change Blindness in Transportation

DOT National Transportation Integrated Search

2009-12-01

Inattentional blindness refers to situations in which a person is unaware of a change that is occurring because attention is not currently focused on what is changing. Change blindness occurs when a change takes place during an eye movement or blink ...

76 FR 32969 - National Technical Assistance and Dissemination Center for Children Who Are Deaf-Blind; Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-07

... ``individuals who are deaf-blind'' refers to infants, toddlers, children, youth and young adults through age 21... grants funded under the Projects for Children and Young Adults who are Deaf-Blind program (CFDA Number 84...

The efficacy of SMART Arm training early after stroke for stroke survivors with severe upper limb disability: a protocol for a randomised controlled trial.

PubMed

Brauer, Sandra G; Hayward, Kathryn S; Carson, Richard G; Cresswell, Andrew G; Barker, Ruth N

2013-07-02

Recovery of upper limb function after stroke is poor. The acute to subacute phase after stroke is the optimal time window to promote the recovery of upper limb function. The dose and content of training provided conventionally during this phase is however, unlikely to be adequate to drive functional recovery, especially in the presence of severe motor disability. The current study concerns an approach to address this shortcoming, through evaluation of the SMART Arm, a non-robotic device that enables intensive and repetitive practice of reaching by stroke survivors with severe upper limb disability, with the aim of improving upper limb function. The outcomes of SMART Arm training with or without outcome-triggered electrical stimulation (OT-stim) to augment movement and usual therapy will be compared to usual therapy alone. A prospective, assessor-blinded parallel, three-group randomised controlled trial is being conducted. Seventy-five participants with a first-ever unilateral stroke less than 4 months previously, who present with severe arm disability (three or fewer out of a possible six points on the Motor Assessment Scale [MAS] Item 6), will be recruited from inpatient rehabilitation facilities. Participants will be randomly allocated to one of three dose-matched groups: SMART Arm training with OT-stim and usual therapy; SMART Arm training without OT-stim and usual therapy; or usual therapy alone. All participants will receive 20 hours of upper limb training over four weeks. Blinded assessors will conduct four assessments: pre intervention (0-weeks), post intervention (4-weeks), 26 weeks and 52 weeks follow-up. The primary outcome measure is MAS item 6. All analyses will be based on an intention-to-treat principle. By enabling intensive and repetitive practice of a functional upper limb task during inpatient rehabilitation, SMART Arm training with or without OT-stim in combination with usual therapy, has the potential to improve recovery of upper limb function in those with severe motor disability. The immediate and long-term effects of SMART Arm training on upper limb impairment, activity and participation will be explored, in addition to the benefit of training with or without OT-stim to augment movement when compared to usual therapy alone. ACTRN12608000457347.

The effect of standard dose multivitamin supplementation on disease progression in HIV-infected adults initiating HAART: a randomized double blind placebo-controlled trial in Uganda.

PubMed

Guwatudde, David; Wang, Molin; Ezeamama, Amara E; Bagenda, Danstan; Kyeyune, Rachel; Wamani, Henry; Manabe, Yukari C; Fawzi, Wafaie W

2015-08-19

Efficacy trials investigating the effect of multivitamin (MV) supplementations among patients on Highly Active Antiretroviral Therapy (HAART) have so far been inconclusive. We conducted a randomized, double blind, placebo controlled trial to determine the effect of one recommended daily allowance (RDA) of MV supplementation on disease progression in patients initiating HAART. Eligible subjects were randomized to receive placebo or MV supplementation including vitamins B-complex, C and E. Participants were followed for up to 18 months. Primary endpoints were: change in CD4 cell count, weight and quality of life (QoL). Secondary endpoints were: i) development of a new or recurrent HIV disease progression event, including all-cause mortality; ii) switching from first- to second-line antiretroviral therapy (ART); and iii) occurrence of an adverse event. Intent-to-treat analysis, using linear regression mixed effects models were used to compare changes over time in the primary endpoints between the study arms. Kaplan-Meier time-to-event analysis and the log-rank test was used to compare HIV disease progression events and all-cause mortality. Four hundred participants were randomized, 200 onto MV and 200 onto placebo. By month 18, the average change in CD4 cell count in the MV arm was 141 cells/uL compared to 147 cells/uL in the placebo arm, a mean difference of -6 · 17 [95 % CI -29 · 3, 16 · 9]. The average change in weight in the MV arm was 3 · 9 kg compared to 3 · 3 kg in the placebo arm, a mean difference of 0 · 54 [95 % CI -0 · 40, 1 · 48]; whereas average change in QoL scores in the MV arm was 6 · 8 compared to 8 · 8 in the placebo arm, a mean difference of -2.16 [95 % CI -4 · 59,0 · 27]. No significant differences were observed in these primary endpoints, or in occurrence of adverse events between the trial arms. One RDA of MV supplementation was safe but did not have an effect on indicators of disease progression among HIV infected adults initiating HAART. Clinical trials NCT01228578 , registered on 15th October 2010.

Emotional valence and contextual affordances flexibly shape approach-avoidance movements

PubMed Central

Saraiva, Ana Carolina; Schüür, Friederike; Bestmann, Sven

2013-01-01

Behavior is influenced by the emotional content—or valence—of stimuli in our environment. Positive stimuli facilitate approach, whereas negative stimuli facilitate defensive actions such as avoidance (flight) and attack (fight). Facilitation of approach or avoidance movements may also be influenced by whether it is the self that moves relative to a stimulus (self-reference) or the stimulus that moves relative to the self (object-reference), adding flexibility and context-dependence to behavior. Alternatively, facilitation of approach avoidance movements may happen in a pre-defined and muscle-specific way, whereby arm flexion is faster to approach positive (e.g., flexing the arm brings a stimulus closer) and arm extension faster to avoid negative stimuli (e.g., extending the arm moves the stimulus away). While this allows for relatively fast responses, it may compromise the flexibility offered by contextual influences. Here we asked under which conditions approach-avoidance actions are influenced by contextual factors (i.e., reference-frame). We manipulated the reference-frame in which actions occurred by asking participants to move a symbolic manikin (representing the self) toward or away from a positive or negative stimulus, and move a stimulus toward or away from the manikin. We also controlled for the type of movements used to approach or avoid in each reference. We show that the reference-frame influences approach-avoidance actions to emotional stimuli, but additionally we find muscle-specificity for negative stimuli in self-reference contexts. We speculate this muscle-specificity may be a fast and adaptive response to threatening stimuli. Our results confirm that approach-avoidance behavior is flexible and reference-frame dependent, but can be muscle-specific depending on the context and valence of the stimulus. Reference-frame and stimulus-evaluation are key factors in guiding approach-avoidance behavior toward emotional stimuli in our environment. PMID:24379794

Adaptive control of dual-arm robots

NASA Technical Reports Server (NTRS)

Seraji, H.

1987-01-01

Three strategies for adaptive control of cooperative dual-arm robots are described. In the position-position control strategy, the adaptive controllers ensure that the end-effector positions of both arms track desired trajectories in Cartesian space despite unknown time-varying interaction forces exerted through the load. In the position-hybrid control strategy, the adaptive controller of one arm controls end-effector motions in the free directions and applied forces in the constraint directions, while the adaptive controller of the other arm ensures that the end-effector tracks desired position trajectories. In the hybrid-hybrid control strategy, the adaptive controllers ensure that both end-effectors track reference position trajectories while simultaneously applying desired forces on the load. In all three control strategies, the cross-coupling effects between the arms are treated as disturbances which are rejected by the adaptive controllers while following desired commands in a common frame of reference. The adaptive controllers do not require the complex mathematical model of the arm dynamics or any knowledge of the arm dynamic parameters or the load parameters such as mass and stiffness. The controllers have simple structures and are computationally fast for on-line implementation with high sampling rates.

Dual-arm manipulators with adaptive control

NASA Technical Reports Server (NTRS)

Seraji, Homayoun (Inventor)

1991-01-01

The described and improved multi-arm invention of this application presents three strategies for adaptive control of cooperative multi-arm robots which coordinate control over a common load. In the position-position control strategy, the adaptive controllers ensure that the end-effector positions of both arms track desired trajectories in Cartesian space despite unknown time-varying interaction forces exerted through a load. In the position-hybrid control strategy, the adaptive controller of one arm controls end-effector motions in the free directions and applied forces in the constraint directions; while the adaptive controller of the other arm ensures that the end-effector tracks desired position trajectories. In the hybrid-hybrid control strategy, the adaptive controllers ensure that both end-effectors track reference position trajectories while simultaneously applying desired forces on the load. In all three control strategies, the cross-coupling effects between the arms are treated as disturbances which are compensated for by the adaptive controllers while following desired commands in a common frame of reference. The adaptive controllers do not require the complex mathematical model of the arm dynamics or any knowledge of the arm dynamic parameters or the load parameters such as mass and stiffness. Circuits in the adaptive feedback and feedforward controllers are varied by novel adaptation laws.

Time Domain Simulations of Arm Locking in LISA

NASA Technical Reports Server (NTRS)

Thorpe, J. I.; Maghami, P.; Livas, Jeff

2011-01-01

Arm locking is a technique that has been proposed for reducing laser frequency fluctuations in the Laser Interferometer Space Antenna (LISA). a gravitational-wave observatory sensitive' in the milliHertz frequency band. Arm locking takes advantage of the geometric stability of the triangular constellation of three spacecraft that comprise LISA to provide a frequency reference with a stability in the LISA measurement band that exceeds that available from a standard reference such as an optical cavity or molecular absorption line. We have implemented a time-domain simulation of arm locking including the expected limiting noise sources (shot noise, clock noise. spacecraft jitter noise. and residual laser frequency noise). The effect of imperfect a priori knowledge of the LISA heterodyne frequencies and associated "pulling" of an arm locked laser is included. We find that our implementation meets requirements both on the noise and dynamic range of the laser frequency.

Design of the Core Stage Inter-Tank Umbilical {CSITU) Compliance Mechanism

NASA Technical Reports Server (NTRS)

Smith, Kurt R.

2013-01-01

Project Goals: a) Design the compliance mechanism for the CSITU system to a 30% level -3D models completed in Pro/Engineer -Relevant design analysis b) Must meet all system requirements and establish basis for proceeding with detailed design. Tasks to be completed: A design that meets requirements for the 30% design review, 01/16/2013. Umbilical arms provide commodities to the launch vehicle prior to T-0. Commodities can range anywhere from hydraulics, pneumatics, cryogenic, electrical, ECS, etc ... Umbilicals commonly employ truss structures to deliver commodities to vehicle. Common configurations include: -Tilt-up -Swing Arm -Hose Drape -Drop Arm Umbilical arms will be mounted to Mobile Launch Platform. SLS currently has 9 T-0 umbilical arms. The compliance refers to the ability of the umbilical to adjust to minor changes in vehicle location. The compliance mechanism refers to the mechanism on the ground support equipment {GSE) that compensates for these changes. For the CSITU, these minor changes, or vehicle excursions, can be up to +4 in. Excursions refer to movements of the vehicle caused by wind loads and thermal expansion. It is ideal to have significant vertical compliance so a passive secondary release mechanism may be implemented.

Worldwide Report, Arms Control.

DTIC Science & Technology

1986-02-04

the other dide, and thus deliberately blind it, unexpectedly occupy it, and thus paralyze it, or completely deny it a retaliatory strike. Third ... space weapons 4,000-5,000 km away can be regarded as practically a universal weapon. Such a weapon can be used for fiülfilüing offensive tasks and

Teaching Controversial Materials: Teaching about the Nuclear Issue.

ERIC Educational Resources Information Center

Wall, Joseph

1986-01-01

Describes difficulties encountered in presenting a college course on nuclear weapons and disarmament. Maintains that such courses must strive for a fuller historical account of the arms race, in addition to stressing the humanistic and ethical questions involved. Warns that controversy will arise and concludes that even blind anger is preferable…

Individual Differences in Susceptibility to Inattentional Blindness

ERIC Educational Resources Information Center

Seegmiller, Janelle K.; Watson, Jason M.; Strayer, David L.

2011-01-01

Inattentional blindness refers to the finding that people do not always see what appears in their gaze. Though inattentional blindness affects large percentages of people, it is unclear if there are individual differences in susceptibility. The present study addressed whether individual differences in attentional control, as reflected by…

Establishment and rapid detection of a heterozygous missense mutation in the CACNA1F gene by ARMS technique with double-base mismatched primers.

PubMed

Yang, W C; Zhu, L; Zhou, B X; Tania, S; Zhou, Q; Khan, M A; Fu, X L; Cheng, J L; Lv, H B; Fu, J J

2015-09-25

Retinitis pigmentosa (RP) is a retinal degenerative disorder that often causes complete blindness. Mutations of more than 50 genes have been identified as associated with RP, including the CACNA1F gene. In a recent study, by employing next-generation sequencing, we identified a novel mutation in the CACNA1F gene. In this study, we used the amplification refractory mutation system (ARMS) and identified a single nucleotide change c.1555C>T in exon 13 of the CACNA1F gene, leading to the substitution of arginine by tryptophan (p.R519W) in a Chinese individual affected by RP. This study actually confirms this novel mutation, and establishes the ARMS technique for the detection of mutations in RP.

Reference ranges for midupper arm circumference, upper arm muscle area, and upper arm fat area in US children and adolescents aged 1-20 y.

PubMed

Addo, O Yaw; Himes, John H; Zemel, Babette S

2017-01-01

Midupper arm circumference (MUAC) has long been used in anthropometric assessments of nutritional status in field settings, especially in emergency situations, but percentile ranges for healthy, well-nourished children are currently unavailable. We developed reference curves for MUAC and derived measures of arm muscle area (AMA) and arm fat area (AFA) on the basis of the population used in the current CDC body mass index growth charts. We analyzed cross-sectional MUAC and triceps (triceps skinfold thickness) data from 32,952 US children aged 1-20 y. Generalized additive models for location, scale, and shape were used to calculate semiparametric smoothed percentiles and L, M, and S coefficients needed for z-score estimation by age and sex. Equations were developed with the use of the height-for-age z score (HAZ) to adjust for the associations of stature with upper arm measures. MUAC increased with age steadily throughout the growing period. For children <5 y old, lower percentile ranges varied markedly across age and sex such that the single cutoff (<11.5 or 12.5 cm) for field screening of acute malnutrition did not track along the same percentile. AFA and AMA growth patterns exhibited sex-specific trends including multiple distinct age-related inflections that were more pronounced in males for AFA-for-age than in females. HAZ and age were substantially and independently related with all arm measures. The new reference percentile ranges for midupper arm measures for healthy children provide a useful nutritional assessment tool in a wide variety of settings. Height status (HAZ) has complex independent associations with arm measures irrespective of the distributional ranking by age and sex. Prediction equations that account for these effects further extend the practical use of the new curves. © 2017 American Society for Nutrition.

40 CFR 1065.310 - Torque calibration.

Code of Federal Regulations, 2013 CFR

2013-07-01

... reference force is measured. The lever arm must be perpendicular to gravity (i.e., horizontal), and it must... known distance along a lever arm. Make sure the weights' lever arm is perpendicular to gravity (i.e... gravity (using this equation: force = mass · acceleration). The local acceleration of gravity, a g, at...

40 CFR 1065.310 - Torque calibration.

Code of Federal Regulations, 2012 CFR

2012-07-01

... reference force is measured. The lever arm must be perpendicular to gravity (i.e., horizontal), and it must... known distance along a lever arm. Make sure the weights' lever arm is perpendicular to gravity (i.e... gravity (using this equation: force = mass · acceleration). The local acceleration of gravity, a g, at...

Risk factors for age-related maculopathy.

PubMed

Connell, Paul P; Keane, Pearse A; O'Neill, Evelyn C; Altaie, Rasha W; Loane, Edward; Neelam, Kumari; Nolan, John M; Beatty, Stephen

2009-01-01

Age-related maculopathy (ARM) is the leading cause of blindness in the elderly. Although beneficial therapeutic strategies have recently begun to emerge, much remains unclear regarding the etiopathogenesis of this disorder. Epidemiologic studies have enhanced our understanding of ARM, but the data, often conflicting, has led to difficulties with drawing firm conclusions with respect to risk for this condition. As a consequence, we saw a need to assimilate the published findings with respect to risk factors for ARM, through a review of the literature appraising results from published cross-sectional studies, prospective cohort studies, case series, and case control studies investigating risk for this condition. Our review shows that, to date, and across a spectrum of epidemiologic study designs, only age, cigarette smoking, and family history of ARM have been consistently demonstrated to represent risk for this condition. In addition, genetic studies have recently implicated many genes in the pathogenesis of age-related maculopathy, including Complement Factor H, PLEKHA 1, and LOC387715/HTRA1, demonstrating that environmental and genetic factors are important for the development of ARM suggesting that gene-environment interaction plays an important role in the pathogenesis of this condition.

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

PubMed Central

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

2011-01-01

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

Postanesthesia patients with large upper arm circumference: is use of an "extra-long" adult cuff or forearm cuff placement accurate?

PubMed

Watson, Sheri; Aguas, Marita; Bienapfl, Tracy; Colegrove, Pat; Foisy, Nancy; Jondahl, Bonnie; Yosses, Mary Beth; Yu, Larissa; Anastas, Zoe

2011-06-01

The purpose of this study was to determine if blood pressure (BP) measured in the forearm or with an extra-long BP cuff in the upper arm accurately reflects BP measured in the upper arm with an appropriately sized BP cuff in patients with large upper arm circumference. A method-comparison design was used with a convenience sample of 49 PACU patients. Noninvasive blood pressures were obtained in two different locations (forearm; upper arm) and in the upper arm with an extra-long adult and recommended large adult cuff sizes. Data were analyzed by calculating bias and precision for the BP cuff size and location and Student's t-tests, with P < .0125 considered significant. Significantly higher forearm systolic (P < .0001) and diastolic (P < .0002) BP measurements were found compared to BP obtained in the upper arm with the reference standard BP cuff. Significantly higher systolic (t(48df) = 5.38, P < .0001), but not diastolic (t(48df) = 4.11, P < .019), BP differences were found for BP measured with the extra-long cuff at the upper arm site compared to the upper arm, reference standard BP. Findings suggest that the clinical practice of using the forearm or an extra-long cuff in the upper arm for BP measurement in post anesthesia patients with large upper arm circumferences may result in inaccurate BP values. Copyright © 2011 American Society of PeriAnesthesia Nurses. Published by Elsevier Inc. All rights reserved.

Bias was reduced in an open-label trial through the removal of subjective elements from the outcome definition.

PubMed

Kahan, Brennan C; Doré, Caroline J; Murphy, Michael F; Jairath, Vipul

2016-09-01

To determine whether modifying an outcome definition to remove subjective elements reduced bias in a trial that could not use blinded outcome assessment. Reanalysis of an open-label trial comparing a restrictive vs. liberal transfusion strategy for gastrointestinal bleeding. The usual definition of the primary outcome, further bleeding, allows subjective clinical symptoms to be used alone for diagnosis, whereas the definition used in the trial required more objective confirmation by endoscopy. We compared treatment effect estimates for these two definitions. Fewer subjective symptom-identified events were confirmed using more objective methods in the restrictive arm (18%) than in the liberal arm (56%), indicating differential assessment between arms. An analysis using all events (both subjective and more objective) led to an odds ratio of 0.83 (95% confidence interval [CI]: 0.50-1.37). When only events confirmed using more objective methods were included, the odds ratio was 0.50 (95% CI: 0.32-0.78). The ratio of the odds ratios was 1.66, indicating that including unconfirmed events in the definition biased the treatment effect upward by 66%. Modifying the outcome definition to exclude subjective elements substantially reduced bias. This may be a useful strategy for reducing bias in trials that cannot blind outcome assessment. Copyright © 2016 Elsevier Inc. All rights reserved.

ARM-based visual processing system for prosthetic vision.

PubMed

Matteucci, Paul B; Byrnes-Preston, Philip; Chen, Spencer C; Lovell, Nigel H; Suaning, Gregg J

2011-01-01

A growing number of prosthetic devices have been shown to provide visual perception to the profoundly blind through electrical neural stimulation. These first-generation devices offer promising outcomes to those affected by degenerative disorders such as retinitis pigmentosa. Although prosthetic approaches vary in their placement of the stimulating array (visual cortex, optic-nerve, epi-retinal surface, sub-retinal surface, supra-choroidal space, etc.), most of the solutions incorporate an externally-worn device to acquire and process video to provide the implant with instructions on how to deliver electrical stimulation to the patient, in order to elicit phosphenized vision. With the significant increase in availability and performance of low power-consumption smart phone and personal device processors, the authors investigated the use of a commercially available ARM (Advanced RISC Machine) device as an externally-worn processing unit for a prosthetic neural stimulator for the retina. A 400 MHz Samsung S3C2440A ARM920T single-board computer was programmed to extract 98 values from a 1.3 Megapixel OV9650 CMOS camera using impulse, regional averaging and Gaussian sampling algorithms. Power consumption and speed of video processing were compared to results obtained to similar reported devices. The results show that by using code optimization, the system is capable of driving a 98 channel implantable device for the restoration of visual percepts to the blind.

Rubella Deaf-Blind Child: Implications of Psychological Assessment. Proceedings.

ERIC Educational Resources Information Center

Rouin, Carole

Presented are proceedings of a conference involving authorities in testing and evaluating the blind, deaf, and deaf-blind. In a paper titled "Psychological Implications of Assessing the Deaf", C. Goetzinger discusses references used in audiology, anatomy and physiology of the ear, degrees of hearing impairment, and implications of the various…

Radial arm strike rail

DOEpatents

McKeown, Mark H.; Beason, Steven C.

1991-01-01

The radial arm strike rail assembly is a system for measurement of bearings, directions, and stereophotography for geologic mapping, particularly where magnetic compasses are not appropriate. The radial arm, pivoting around a shaft axis, provides a reference direction determination for geologic mapping and bearing or direction determination. The centerable and levelable pedestal provide a base for the radial arm strike rail and the telescoping camera pedestal. The telescoping feature of the radial arm strike rail allows positioning the end of the rail for strike direction or bearing measurement with a goniometer.

Polylactic acid vs. polyacrylamide hydrogel for treatment of facial lipoatrophy: a randomized controlled trial [Agence Nationale de Recherches sur le SIDA et les Hépatites Virales (ANRS) 132 SMILE].

PubMed

Lafaurie, M; Dolivo, M; Girard, P-M; May, T; Bouchaud, O; Carbonnel, E; Madelaine, I; Loze, B; Porcher, R; Molina, J-M

2013-08-01

The aim of the study was to demonstrate the noninferiority of polyacrylamide hydrogel (PH) vs. polylactic acid (PLA) for the treatment of facial lipoatrophy in HIV-infected adults. A randomized, blinded, multicentre, noninferiority 96-week study was carried out. Patients with facial lipoatrophy were randomly assigned to receive intradermal injections with PH or PLA, and were blinded to the filler. The primary efficacy endpoint was patient satisfaction at week 48 assessed using a visual analogue scale score (VAS). Secondary efficacy end-points included cheek thickness and skin-fold, lipoatrophy grading and quality of life. Safety was assessed by the reporting of adverse events. A total of 148 patients were included in the study; 93% were men, the median age was 47 years, the median CD4 count was 528 cells/μL, and the median duration of antiretroviral therapy was 12 years. Mean VAS increased from 2.8 at baseline to 7.1 and 7.5 in the PLA and PH arms, respectively, at week 48 (P=0.0002 for noninferiority) and was sustained at week 96 (6.7 and 7.9 in the PLA and PH arms, respectively; P=0.003 for noninferiority). Cheek thickness and skin-fold increases and lipoatrophy improvement were similar in the two arms. Quality of life remained unchanged or improved depending on the questionnaire used. In injected patients, subcutaneous nodules emerged in 28 (41%) and 26 (37%) patients in the PLA and PH arms, respectively (P=0.73). Four patients in the PH arm developed severe inflammatory nodules, a median of 17 months after the last injection. PH and PLA have similar efficacies in the treatment of facial lipoatrophy, but PH may be associated with more delayed inflammatory nodules. © 2013 British HIV Association.

Myofascial Induction Effects on Neck-Shoulder Pain in Breast Cancer Survivors: Randomized, Single-Blind, Placebo-Controlled Crossover Design.

PubMed

Castro-Martín, Eduardo; Ortiz-Comino, Lucía; Gallart-Aragón, Tania; Esteban-Moreno, Bernabé; Arroyo-Morales, Manuel; Galiano-Castillo, Noelia

2017-05-01

To (1) investigate the immediate effects of myofascial induction (MI), with placebo electrotherapy as a control, on perceived pain, cervical/shoulder range of motion (ROM), and mood state in breast cancer survivors (BCSs) with shoulder/arm morbidity; and (2) examine the relationships between pain modifications and cervical/shoulder ROM on the side affected by breast cancer. Randomized, single-blind, placebo-controlled crossover study. Physical therapy laboratory. BCSs (N=21) who had a diagnosis of stage I-IIIA breast cancer and had completed adjuvant therapy (except hormonal treatment). During each session, the BCSs received either an MI (fascial unwinding) intervention focused on the upper limb area following the Pilat approach or placebo pulsed shortwave therapy (control group). Each session lasted 30 minutes, and an adequate washout period of 4 weeks between sessions was established. The visual analog scale (VAS) for pain and anxiety, shoulder-cervical goniometry for ROM, the Profile of Mood States for psychological distress, and the Attitudes Towards Massage Scale were used. An analysis of covariance (ANCOVA) revealed significant time × group interactions for VAS affected arm (P=.031) but not for VAS cervical (P=.332), VAS nonaffected arm (P=.698), or VAS anxiety (P=.266). The ANCOVA also revealed significant interactions for affected shoulder flexion (P<.001), abduction (P<.001), external rotation (P=.004), and internal rotation (P=.001). Significant interactions for affected cervical rotation (P=.022) and affected cervical lateral flexion (P=.038) were also found. A significant negative correlation was found between changes in VAS affected arm and shoulder/arm internal rotation ROM (r=-.46; P=.03). A single MI session decreases pain intensity and improves neck-shoulder ROM to a greater degree than placebo electrotherapy for BCSs experiencing pain. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Multicenter, Double-Blind, Placebo-Controlled, Randomized Phase II Trial of Gemcitabine/Cisplatin Plus Bevacizumab or Placebo in Patients With Malignant Mesothelioma

PubMed Central

Kindler, Hedy L.; Karrison, Theodore G.; Gandara, David R.; Lu, Charles; Krug, Lee M.; Stevenson, James P.; Jänne, Pasi A.; Quinn, David I.; Koczywas, Marianna N.; Brahmer, Julie R.; Albain, Kathy S.; Taber, David A.; Armato, Samuel G.; Vogelzang, Nicholas J.; Chen, Helen X.; Stadler, Walter M.; Vokes, Everett E.

2012-01-01

Purpose Gemcitabine plus cisplatin is active in malignant mesothelioma (MM), although single-arm phase II trials have reported variable outcomes. Vascular endothelial growth factor (VEGF) inhibitors have activity against MM in preclinical models. We added the anti-VEGF antibody bevacizumab to gemcitabine/cisplatin in a multicenter, double-blind, placebo-controlled randomized phase II trial in patients with previously untreated, unresectable MM. Patients and Methods Eligible patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 and no thrombosis, bleeding, or major blood vessel invasion. The primary end point was progression-free survival (PFS). Patients were stratified by ECOG performance status (0 v 1) and histologic subtype (epithelial v other). Patients received gemcitabine 1,250 mg/m2 on days 1 and 8 every 21 days, cisplatin 75 mg/m2 every 21 days, and bevacizumab 15 mg/kg or placebo every 21 days for six cycles, and then bevacizumab or placebo every 21 days until progression. Results One hundred fifteen patients were enrolled at 11 sites; 108 patients were evaluable. Median PFS time was 6.9 months for the bevacizumab arm and 6.0 months for the placebo arm (P = .88). Median overall survival (OS) times were 15.6 and 14.7 months in the bevacizumab and placebo arms, respectively (P = .91). Partial response rates were similar (24.5% for bevacizumab v 21.8% for placebo; P = .74). A higher pretreatment plasma VEGF concentration (n = 56) was associated with shorter PFS (P = .02) and OS (P = .0066), independent of treatment arm. There were no statistically significant differences in toxicity of grade 3 or greater. Conclusion The addition of bevacizumab to gemcitabine/cisplatin in this trial did not significantly improve PFS or OS in patients with advanced MM. PMID:22665541

Efficacy of a Carrageenan gel Against Transmission of Cervical HPV (CATCH): Interim analysis of a randomized, double-blind, placebo-controlled, phase 2B trial.

PubMed

Magnan, Sindy; Tota, Joseph E; El-Zein, Mariam; Burchell, Ann N; Schiller, John T; Ferenczy, Alex; Tellier, Pierre-Paul; Coutlée, François; Franco, Eduardo L

2018-04-20

We evaluated the efficacy of a carrageenan-based lubricant gel in reducing the risk of genital human papillomavirus (HPV) infections in women. We conducted a planned interim analysis of a randomized, double-blind, placebo-controlled, phase 2B trial. Women aged 18 years and older were randomly assigned (1:1) to a carrageenan-based or a placebo gel to be self-applied every other day for the first month and prior to and following each intercourse during follow-up. Assessments were done at 0·5, 1, 3, 6, 9, and 12 months. The primary outcome was incidence of a new infection by an HPV type that was not present at baseline. Analyses were performed by intention-to-treat. Between January 2013 and June 2017, 280 participants were randomly assigned to the carrageenan (n=141) or the placebo (n=139) arm. All participants were included in safety analyses, but 3 (1%) were excluded from efficacy analyses (HPV results unavailable: carrageenan=2, placebo=1). The median follow-up time was 9·2 months (inter-quartile range: 1·9-13·2). 59 (42%) of 139 participants in the carrageenan arm and 78 (57%) of 138 participants in the placebo arm got infected by at least one new HPV type (hazard ratio=0·64, 95% confidence interval=0·45-0·89, p=0·009). 62 (44%) of 141 participants in the carrageenan arm versus 43 (31%) of 139 participants in the placebo arm reported an adverse event (p=0.02); none of which were deemed related to the gels. Our trial's interim analysis suggests that using a carrageenan-based lubricant gel can reduce the risk of genital HPV infections in women. Copyright © 2018 European Society of Clinical Microbiology and Infectious Diseases. All rights reserved.

Short-Term Effects of Thoracic Spine Manipulation on Shoulder Impingement Syndrome: A Randomized Controlled Trial.

PubMed

Haik, Melina N; Alburquerque-Sendín, Francisco; Camargo, Paula R

2017-08-01

To investigate the short-term effects of thoracic spine manipulation (TSM) on pain, function, scapular kinematics, and scapular muscle activity in individuals with shoulder impingement syndrome. Randomized controlled trial with blinded assessor and patient. Laboratory. Patients with shoulder impingement syndrome (N=61). Participants were randomly allocated to TSM group (n=30) or sham-TSM group (n=31) and attended 2 intervention sessions over a 1-week period. Scapular kinematics and muscle activity were measured at day 1 (baseline, before the first intervention), day 2 preintervention (before second intervention), day 2 postintervention (after the second intervention), and day 3 (follow-up). Shoulder pain and function were assessed by the Disability of the Arm, Shoulder and Hand questionnaire and Western Ontario Rotator Cuff Index at baseline, day 2 preintervention, and follow-up. An assessor blinded to group assignment measured all outcomes. Pain decreased by 0.7 points (95% confidence interval, 1.3-0.1 points) at day 2 preintervention and 0.9 points (95% confidence interval, 1.5-0.3 points) at day 2 postintervention in the TSM group. The Disability of the Arm, Shoulder and Hand questionnaire (P=.01) and Western Ontario Rotator Cuff Index (P=.02) scores improved in both groups. Scapular upward rotation increased during arm lowering (P<.01) at day 2 postintervention (5.3°) and follow-up (3.5°) in the TSM group. Upper trapezius activity increased (P<.05) in the sham-TSM group. Middle trapezius, lower trapezius, and serratus anterior decreased activities in both groups during elevation and lowering of the arm. TSM may increase scapular upward rotation during arm lowering. TSM does not seem to influence activity of the scapular muscles. The results concerning shoulder pain, function, scapular tilt, and internal rotation are not conclusive. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

HBOC-201 as an alternative to blood transfusion: efficacy and safety evaluation in a multicenter phase III trial in elective orthopedic surgery.

PubMed

Jahr, Jonathan S; Mackenzie, Colin; Pearce, L Bruce; Pitman, Arkadiy; Greenburg, A Gerson

2008-06-01

The ability of hemoglobin based oxygen carrier-201 (HBOC-201) to safely reduce and/or eliminate perioperative transfusion was studied in orthopedic surgery patients. A randomized, single-blind, packed red blood cell (PRBC)-controlled, parallel-group multicenter study was conducted. Six hundred eighty-eight patients were randomized to treatment with HBOC-201 (H, n = 350) or PRBC (R, n = 338) at the first transfusion decision. Primary endpoints were transfusion avoidance and blinded assessment [Mann-Whitney estimator (MW)] of safety noninferiority. Groups were compared directly and by paired/matching group analyses predicated on a prospectively defined dichotomy [treatment success (HH) vs. failure (HR)] in the H arm and an equivalently defined dichotomy [3 (R3+) units PRBC] in the R arm, based on need (moderate vs. high) for additional oxygen carrying capacity. A total of 59.4% of patients in the H arm avoided PRBC transfusion. Adverse events (8.47 vs. 5.88), and serious adverse events (SAEs) (0.35 vs. 0.25) per patient were higher in the H versus R arms (p < 0.001 and p < 0.01) with MW = 0.561 (95 CI 0.528-0.594). HH versus R3- had identical (0.14) serious adverse events/patient and a MW = 0.519 (95% confidence limit 0.481-0.558), whereas the incidence was higher (0.63 vs. 0.47) for HR versus R3+ with a MW = 0.605 (95% confidence limit 0.550-0.662). Age (>80 years), volume overload and undertreatment contributed to this imbalance. HBOC-201 eliminated transfusion in the majority of subjects. The between arms (H vs. R) safety analysis was unfavorable and likely related to patient age, volume overload, and undertreatment and was isolated to patients that could not be managed by HBOC-201 alone. However, patients <80 years old with moderate clinical need may safely avoid transfusion when treated with up to 10 units of HBOC-201.

Effects of Action Observational Training Plus Brain-Computer Interface-Based Functional Electrical Stimulation on Paretic Arm Motor Recovery in Patient with Stroke: A Randomized Controlled Trial.

PubMed

Kim, TaeHoon; Kim, SeongSik; Lee, ByoungHee

2016-03-01

The purpose of this study was to investigate whether action observational training (AOT) plus brain-computer interface-based functional electrical stimulation (BCI-FES) has a positive influence on motor recovery of paretic upper extremity in patients with stroke. This was a hospital-based, randomized controlled trial with a blinded assessor. Thirty patients with a first-time stroke were randomly allocated to one of two groups: the BCI-FES group (n = 15) and the control group (n = 15). The BCI-FES group administered to AOT plus BCI-FES on the paretic upper extremity five times per week during 4 weeks while both groups received conventional therapy. The primary outcomes were the Fugl-Meyer Assessment of the Upper Extremity, Motor Activity Log (MAL), Modified Barthel Index and range of motion of paretic arm. A blinded assessor evaluated the outcomes at baseline and 4 weeks. All baseline outcomes did not differ significantly between the two groups. After 4 weeks, the Fugl-Meyer Assessment of the Upper Extremity sub-items (total, shoulder and wrist), MAL (MAL-Activity of Use and Quality of Movement), Modified Barthel Index and wrist flexion range of motion were significantly higher in the BCI-FES group (p < 0.05). AOT plus BCI-based FES is effective in paretic arm rehabilitation by improving the upper extremity performance. The motor improvements suggest that AOT plus BCI-based FES can be used as a therapeutic tool for stroke rehabilitation. The limitations of the study are that subjects had a certain limited level of upper arm function, and the sample size was comparatively small; hence, it is recommended that future large-scale trials should consider stratified and lager populations according to upper arm function. Copyright © 2015 John Wiley & Sons, Ltd.

Slow infusion of low{\\hyphen}dose ketamine reduces bothersome side effects compared to IV push: a double{\\hyphen}blind, double dummy, randomized controlled trial.

PubMed

Clattenburg, Eben J; Hailozian, Christian; Haro, Daniel; Yoo, Tina; Flores, Stefan; Louie, Derex; Herring, Andrew A

2018-04-12

We compared the analgesic efficacy and incidence of side effects when low{\\hyphen}dose (0.3 mg{\\sol}kg) ketamine (LDK) is administered as a slow infusion (SI) over 15 minutes versus an intravenous push (IVP) over one minute. This was a prospective, randomized, double blind, double dummy, placebo{\\hyphen}controlled trial of adult ED patients presenting with moderate to severe pain (numerical rating score ≥ 5). Patients received ketamine 0.3mg{\\sol}kg administered either as a SI or IVP. Our primary outcome was the proportion of patients experiencing any psychoperceptual side effect over 60 minutes. A secondary outcome was incidence of moderate or greater psychoperceptual side effects. Additional outcomes included reduction in pain NRS scores at 60 minutes and percent maximum summed pain intensity difference ({\\percnt}SPID). Fifty{\\hyphen}nine participants completed the study. 86.2{\\percnt} of the IVP arm and 70.0{\\percnt} of the SI arm experienced any side effect (difference 16.2{\\percnt}, 95{\\percnt}CI {\\hyphen}5.4 - 37.8). We found a large reduction in moderate or greater psychoperceptual side effects with SI administration-75.9{\\percnt} reported moderate or greater side effects versus 43.4{\\percnt} in the SI arm (difference 32.5{\\percnt}, 95{\\percnt}CI 7.9 - 57.1). Additionally, the IVP arm experienced more hallucinations (n{\\equal}8, 27.6{\\percnt}) than the SI arm (SI n{\\equal}2, 6.7{\\percnt}; difference 20.9{\\percnt}, 95{\\percnt}CI 1.8 - 43.4). We found no significant differences in analgesic efficacy. At 60 minutes, the mean {\\percnt}SPID in the IVP and SI arms was 39.9{\\percnt} and 33.5{\\percnt}, respectively, with a difference of 6.5{\\percnt} (95{\\percnt}CI {\\hyphen}5.8 - 18.7). Most patients who are administered LDK experience a psychoperceptual side effect regardless of administration via SI or IVP. However, patients receiving LDK as a SI reported significantly fewer moderate or greater psychoperceptual side effects and hallucinations with equivalent analgesia. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Randomized, Controlled Trial of the Effect of Dietary Potassium Restriction on Nerve Function in CKD.

PubMed

Arnold, Ria; Pianta, Timothy J; Pussell, Bruce A; Kirby, Adrienne; O'Brien, Kate; Sullivan, Karen; Holyday, Margaret; Cormack, Christine; Kiernan, Matthew C; Krishnan, Arun V

2017-10-06

Neuromuscular complications are almost universal in CKD by the time that a patient commences dialysis. Recent studies have indicated that chronic hyperkalemia may contribute to the development of neuropathy in CKD. This study was undertaken to determine whether dietary restriction of potassium intake may be a neuroprotective factor in CKD. A 24-month prospective, single-blind, randomized, controlled trial was undertaken in 47 consecutively recruited patients with stages 3 and 4 CKD. The intervention arm ( n =23) was prescribed a diet focusing on potassium restriction to meet a monthly serum potassium level of ≤4.5 mEq/L, with oral sodium polystyrene sulfonate provided if dietary advice failed to achieve the target. The control arm ( n =24) received dietary advice regarding general nutrition. The primary outcome was the change in the total neuropathy score evaluated by a blinded observer. Secondary outcomes included electrolyte levels, gait speed, neurophysiologic parameters, and health-related quality of life scores. Five patients withdrew before initiation of treatment, and final analysis consisted of n =21 in each group. There was a greater increase in total neuropathy score from baseline to final assessment in the control arm compared with the intervention arm (6.1±6.2-8.6±7.9 controls; 7.8±7.4-8.2±7.5 intervention; change 2.8±3.3-0.4±2.2, respectively; P <0.01). The intervention significantly reduced mean serum potassium compared with controls (4.6±0.1-4.8±0.1 mEq/L mean recorded every 6 months over the trial duration; P =0.03). There were no adverse changes in other nutritional parameters. Improved gait speed was also noted in the intervention arm compared with the control arm, with a mean increase of 0.15±0.17 m/s in the intervention group versus 0.02±0.16 m/s in the control group ( P =0.01). Our results provide important preliminary evidence that dietary potassium restriction confers neuroprotection in CKD and should be confirmed in a larger multicenter trial. Copyright © 2017 by the American Society of Nephrology.

Recombinant human growth hormone and rosiglitazone for abdominal fat accumulation in HIV-infected patients with insulin resistance: a randomized, double-blind, placebo-controlled, factorial trial.

PubMed

Glesby, Marshall J; Albu, Jeanine; Chiu, Ya-Lin; Ham, Kirsis; Engelson, Ellen; He, Qing; Muthukrishnan, Varalakshmi; Ginsberg, Henry N; Donovan, Daniel; Ernst, Jerry; Lesser, Martin; Kotler, Donald P

2013-01-01

Recombinant human growth hormone (rhGH) reduces visceral adipose tissue (VAT) volume in HIV-infected patients but can worsen glucose homeostasis and lipoatrophy. We aimed to determine if adding rosiglitazone to rhGH would abrogate the adverse effects of rhGH on insulin sensitivity (SI) and subcutaneous adipose tissue (SAT) volume. Randomized, double-blind, placebo-controlled, multicenter trial using a 2×2 factorial design in which HIV-infected subjects with abdominal obesity and insulin resistance were randomized to rhGH 3 mg daily, rosiglitazone 4 mg twice daily, combination rhGH + rosiglitazone, or double placebo (control) for 12 weeks. The primary endpoint was change in SI by frequently sampled intravenous glucose tolerance test from entry to week 12. Body composition was assessed by whole body magnetic resonance imaging (MRI) and dual Xray absorptiometry (DEXA). Seventy-seven subjects were randomized of whom 72 initiated study drugs. Change in SI from entry to week 12 differed across the 4 arms by 1-way ANCOVA (P = 0.02); by pair-wise comparisons, only rhGH (decreasing SI; P = 0.03) differed significantly from control. Changes from entry to week 12 in fasting glucose and glucose area under the curve on 2-hour oral glucose tolerance test differed across arms (1-way ANCOVA P = 0.004), increasing in the rhGH arm relative to control. VAT decreased significantly in the rhGH arms (-17.5% in rhGH/rosiglitazone and -22.7% in rhGH) but not in the rosiglitazone alone (-2.5%) or control arms (-1.9%). SAT did not change significantly in any arm. DEXA results were consistent with the MRI data. There was no significant rhGH x rosiglitazone interaction for any body composition parameter. The addition of rosiglitazone abrogated the adverse effects of rhGH on insulin sensitivity and glucose tolerance while not significantly modifying the lowering effect of rhGH on VAT. Clinicaltrials.gov NCT00130286.

Recombinant Human Growth Hormone and Rosiglitazone for Abdominal Fat Accumulation in HIV-Infected Patients with Insulin Resistance: A Randomized, Double-Blind, Placebo-Controlled, Factorial Trial

PubMed Central

Glesby, Marshall J.; Albu, Jeanine; Chiu, Ya-Lin; Ham, Kirsis; Engelson, Ellen; He, Qing; Muthukrishnan, Varalakshmi; Ginsberg, Henry N.; Donovan, Daniel; Ernst, Jerry; Lesser, Martin; Kotler, Donald P.

2013-01-01

Background Recombinant human growth hormone (rhGH) reduces visceral adipose tissue (VAT) volume in HIV-infected patients but can worsen glucose homeostasis and lipoatrophy. We aimed to determine if adding rosiglitazone to rhGH would abrogate the adverse effects of rhGH on insulin sensitivity (SI) and subcutaneous adipose tissue (SAT) volume. Methodology/Principal Findings Randomized, double-blind, placebo-controlled, multicenter trial using a 2×2 factorial design in which HIV-infected subjects with abdominal obesity and insulin resistance were randomized to rhGH 3 mg daily, rosiglitazone 4 mg twice daily, combination rhGH + rosiglitazone, or double placebo (control) for 12 weeks. The primary endpoint was change in SI by frequently sampled intravenous glucose tolerance test from entry to week 12. Body composition was assessed by whole body magnetic resonance imaging (MRI) and dual Xray absorptiometry (DEXA). Seventy-seven subjects were randomized of whom 72 initiated study drugs. Change in SI from entry to week 12 differed across the 4 arms by 1-way ANCOVA (P = 0.02); by pair-wise comparisons, only rhGH (decreasing SI; P = 0.03) differed significantly from control. Changes from entry to week 12 in fasting glucose and glucose area under the curve on 2-hour oral glucose tolerance test differed across arms (1-way ANCOVA P = 0.004), increasing in the rhGH arm relative to control. VAT decreased significantly in the rhGH arms (−17.5% in rhGH/rosiglitazone and −22.7% in rhGH) but not in the rosiglitazone alone (−2.5%) or control arms (−1.9%). SAT did not change significantly in any arm. DEXA results were consistent with the MRI data. There was no significant rhGH x rosiglitazone interaction for any body composition parameter. Conclusions/Significance The addition of rosiglitazone abrogated the adverse effects of rhGH on insulin sensitivity and glucose tolerance while not significantly modifying the lowering effect of rhGH on VAT. Trial Registration Clinicaltrials.gov NCT00130286 PMID:23593417

Method and apparatus for adaptive force and position control of manipulators

NASA Technical Reports Server (NTRS)

Seraji, Homayoun (Inventor)

1995-01-01

The described and improved multi-arm invention of this application presents three strategies for adaptive control of cooperative multi-arm robots which coordinate control over a common load. In the position-position control strategy, the adaptive controllers ensure that the end-effector positions of both arms track desired trajectories in Cartesian space despite unknown time-varying interaction forces exerted through a load. In the position-hybrid control strategy, the adaptive controller of one arm controls end-effector motions in the free directions and applied forces in the constraint directions; while the adaptive controller of the other arm ensures that the end-effector tracks desired position trajectories. In the hybrid-hybrid control strategy, the adaptive controllers ensure that both end-effectors track reference position trajectories while simultaneously applying desired forces on the load. In all three control strategies, the cross-coupling effects between the arms are treated as disturbances which are compensated for by the adaptive controllers while following desired commands in a common frame of reference. The adaptive controllers do not require the complex mathematical model of the arm dynamics or any knowledge of the arm dynamic parameters or the load parameters such as mass and stiffness. Circuits in the adaptive feedback and feedforward controllers are varied by novel adaptation laws.

Assessment of volume measurement of breast cancer-related lymphedema by three methods: circumference measurement, water displacement, and dual energy X-ray absorptiometry.

PubMed

Gjorup, Caroline; Zerahn, Bo; Hendel, Helle W

2010-06-01

Following treatment for breast cancer 12%-60% develop breast cancer-related lymphedema (BCRL). There are several ways of assessing BCRL. Circumference measurement (CM) and water displacement (WD) for volume measurements (VM) are frequently used methods in practice and research, respectively. The aim of this study was to evaluate CM and WD for VM of the BCRL arm and the contralateral arm, comparing the results with regional dual energy X-ray absorptiometry (DXA). Twenty-four women with unilateral BCRL were included in the study. Blinded duplicate VM were obtained from both arms using the three methods mentioned above. CM and DXA were performed by two observers. WD was performed by a group of observers. Mean differences (d) in duplicated volumes, limits of agreement (LOA), and 95% confidence intervals (CI) were calculated for each method. The repeatability expressed as d (95% CI) between the duplicated VM of the BCRL arm and the contralateral arm was for DXA 3 ml (-6-11) and 3 ml (1-7), respectively. For CM and WD, the d (95% CI) of the BCRL arm were 107 ml (86-127) and 26 ml (-26-79), respectively and in the contralateral arm 100 ml (78-122) and -6 ml (-29-17), respectively. DXA is superior in repeatability when compared to CM and WD for VM, especially for the BCRL arm but also the contralateral arm.

Decontamination of stethoscope membranes with chlorhexidine: Should it be recommended?

PubMed

Álvarez, José A; Ruíz, Susana R; Mosqueda, Juan L; León, Ximena; Arreguín, Virginia; Macías, Alejandro E; Macias, Juan H

2016-11-01

To determine differences in the recontamination of stethoscope membranes after cleaning with chlorhexidine, triclosan, or alcohol. Experimental, controlled, blinded trial to determine differences in the bacterial load on stethoscope membranes. Membranes were cultured by direct imprint after disinfection with 70% isopropyl alcohol, 1% triclosan, or 1% chlorhexidine and normal use for 4 hours. As a baseline and an immediate effect control, bacterial load of membranes without disinfection and after 1 minute of disinfection with isopropyl alcohol was determined as well. Three hundred seventy cultures of in-use stethoscopes were taken, 74 from each arm. In the baseline arm the median growth was 10 CFU (interquartile range [IQR], 32-42 CFU); meanwhile, in the isopropyl alcohol immediate-effect arm it was 0 CFU (IQR, 0-0 CFU). In the arms cultured after 4 hours, a median growth of 8 CFU (IQR, 1-28 CFU) in the isopropyl alcohol arm, 4 CFU (IQR, 0-17 CFU) in the triclosan arm, and 0 CFU (IQR, 0-1 CFU) in the chlorhexidine arm were seen. No significant differences were observed between the bacterial load of the chlorhexidine arm (after 4 hours of use) and that of the isopropyl alcohol arm (after 1 minute without use) (Z= 2.41; P > .05). Chlorhexidine can inhibit recontamination of stethoscope membranes and its use could help avoid cross-infection. Copyright © 2016 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Group art therapy as an adjunctive treatment for people with schizophrenia: multicentre pragmatic randomised trial

PubMed Central

Killaspy, Helen; Barnes, Thomas R E; Barrett, Barbara; Byford, Sarah; Clayton, Katie; Dinsmore, John; Floyd, Siobhan; Hoadley, Angela; Johnson, Tony; Kalaitzaki, Eleftheria; King, Michael; Leurent, Baptiste; Maratos, Anna; O’Neill, Francis A; Osborn, David P; Patterson, Sue; Soteriou, Tony; Tyrer, Peter; Waller, Diane

2012-01-01

Objectives To evaluate the clinical effectiveness of group art therapy for people with schizophrenia and to test whether any benefits exceed those of an active control treatment. Design Three arm, rater blinded, pragmatic, randomised controlled trial. Setting Secondary care services across 15 sites in the United Kingdom. Participants 417 people aged 18 or over, who had a diagnosis of schizophrenia and provided written informed consent to take part in the study. Interventions Participants, stratified by site, were randomised to 12 months of weekly group art therapy plus standard care, 12 months of weekly activity groups plus standard care, or standard care alone. Art therapy and activity groups had up to eight members and lasted for 90 minutes. In art therapy, members were given access to a range of art materials and encouraged to use these to express themselves freely. Members of activity groups were offered various activities that did not involve use of art or craft materials and were encouraged to collectively select those they wanted to pursue. Main outcome measures The primary outcomes were global functioning, measured using the global assessment of functioning scale, and mental health symptoms, measured using the positive and negative syndrome scale, 24 months after randomisation. Main secondary outcomes were levels of group attendance, social functioning, and satisfaction with care at 12 and 24 months. Results 417 participants were assigned to either art therapy (n=140), activity groups (n=140), or standard care alone (n=137). Primary outcomes between the three study arms did not differ. The adjusted mean difference between art therapy and standard care at 24 months on the global assessment of functioning scale was −0.9 (95% confidence interval −3.8 to 2.1), and on the positive and negative syndrome scale was 0.7 (−3.1 to 4.6). Secondary outcomes did not differ between those referred to art therapy or those referred to standard care at 12 or 24 months. Conclusions Referring people with established schizophrenia to group art therapy as delivered in this trial did not improve global functioning, mental health, or other health related outcomes. Trial registration Current Controlled Trials ISRCTN46150447. PMID:22374932

Randomized, Double-Blind Study of Emtricitabine (FTC) plus Clevudine versus FTC Alone in Treatment of Chronic Hepatitis B

PubMed Central

Lim, Seng Gee; Krastev, Zahary; Ng, Tay Meng; Mechkov, Grigor; Kotzev, Iskren Andreev; Chan, Sing; Mondou, Elsa; Snow, Andrea; Sorbel, Jeff; Rousseau, Franck

2006-01-01

Emtricitabine (FTC) is approved for the treatment of human immunodeficiency virus. FTC and clevudine (CLV) have activity against hepatitis B virus (HBV). This report summarizes the results of a double-blind, multicenter study of patients with chronic hepatitis B who had completed a phase 3 study of FTC and were randomized 1:1 to 200 mg FTC once daily (QD) plus 10 mg CLV QD or 200 mg FTC QD plus placebo for 24 weeks with 24 weeks of follow-up. One hundred sixty-three patients were treated (82 with FTC plus CLV [FTC+CLV] and 81 with FTC); 72% were men, 53% were Asian, 47% were Caucasian, and 52% were hepatitis B e antigen positive, and the median baseline HBV DNA level was 6 log10 copies/ml. After 24 weeks of treatment, 74% (FTC+CLV) versus 65% (FTC alone) had serum HBV DNA levels of <4,700 copies/ml (P = 0.114) (Digene HBV Hybrid Capture II assay). Twenty-four weeks posttreatment, the mean change in serum HBV DNA levels from baseline was −1.25 log10 copies/ml (FTC+CLV), 40% had undetectable viremia (versus 23% for FTC alone), and 63% had normal alanine aminotransferase levels (versus 42% for FTC alone) (P ≤ 0.025 for all endpoints). The safety profile was similar between arms during treatment, with less posttreatment exacerbation of hepatitis B in the combination arm. In summary, after 24 weeks of treatment, no significant difference between arms was observed, but there was a significantly greater virologic and biochemical response 24 weeks posttreatment in the FTC+CLV arm. PMID:16641430

Tolerability of the capsaicin 8% patch following pretreatment with lidocaine or tramadol in patients with peripheral neuropathic pain: a multicentre, randomized, assessor-blinded study.

PubMed

Jensen, T S; Høye, K; Fricová, J; Vanelderen, P; Ernault, E; Siciliano, T; Marques, S

2014-10-01

Application of the capsaicin 8% patch is associated with treatment-related discomfort. Consequently, pretreatment for 60 min with anaesthetic cream is recommended; however, this may be uncomfortable and time consuming. We conducted a multicentre, randomized (1:1), assessor-blinded study in patients with peripheral neuropathic pain to assess tolerability of the capsaicin patch following topical lidocaine (4%) or oral tramadol (50 mg) pretreatment. The primary endpoint was the proportion of patients tolerating capsaicin patch application (ability to receive ≥90% of a 60-min application). Numeric Pain Rating Scale (NPRS) scores were assessed before, during and after treatment. Overall, 122 patients were included (61 per arm). The capsaicin patch was tolerated by 121 patients. Tolerability of the capsaicin patch was similar following pretreatment with lidocaine and tramadol. Following patch application, pain levels increased up to 55 min (change from baseline of 1.3 for lidocaine and 1.4 for tramadol). After patch removal, tramadol-treated patients experienced greater pain relief up to the end of day 1; in the evening, mean changes in NPRS scores from baseline were 0 for lidocaine and -1 for tramadol. Proportions of patients reporting increases of ≥2 NPRS points or >33% from baseline at one or more time point(s) on the day of treatment were similar between arms. Adverse event incidence was comparable between arms. Capsaicin 8% patch tolerability was similar in the two arms, with comparable results for most secondary endpoints. Tramadol given 30 min before patch application should be considered as an alternative pretreatment option in patients receiving capsaicin patch treatment. © 2014 The Authors. European Journal of Pain published by John Wiley & Sons Ltd on behalf of European Pain Federation - EFIC®.

Topical gentian violet compared with nystatin oral suspension for the treatment of oropharyngeal candidiasis in HIV-1-infected participants.

PubMed

Mukherjee, Pranab K; Chen, Huichao; Patton, Lauren L; Evans, Scott; Lee, Anthony; Kumwenda, Johnstone; Hakim, James; Masheto, Gaerolwe; Sawe, Frederick; Pho, Mai T; Freedberg, Kenneth A; Shiboski, Caroline H; Ghannoum, Mahmoud A; Salata, Robert A

2017-01-02

Compare the safety and efficacy of topical gentian violet with that of nystatin oral suspension (NYS) for the treatment of oropharyngeal candidiasis in HIV-1-infected adults in resource-limited settings. Multicenter, open-label, evaluator-blinded, randomized clinical trial at eight international sites, within the AIDS Clinical Trials Group. Adult HIV-infected participants with oropharyngeal candidiasis, stratified by CD4 cell counts and antiretroviral therapy status at study entry, were randomized to receive either gentian violet (0.00165%, BID) or NYS (500 000 units, QID) for 14 days. Cure or improvement after 14 days of treatment. Signs and symptoms of oropharyngeal candidiasis were evaluated in an evaluator-blinded manner. The study was closed early per Data Safety Monitoring Board after enrolling 221 participants (target = 494). Among the 182 participants eligible for efficacy analysis, 63 (68.5%) in the gentian violet arm had cure or improvement of oropharyngeal candidiasis versus 61 (67.8%) in the NYS arm, resulting in a nonsizable difference of 0.007 (95% confidence interval: -0.129, 0.143). There was no sizable difference in cure rates between the two arms (-0.0007; 95% confidence interval: -0.146, 0.131). No gentian violet-related adverse events were noted. No sizable differences were identified in tolerance, adherence, quality of life, or acceptability of study drugs. In gentian violet arm, 61 and 39% of participants reported 'no' and 'mild-to-moderate' staining, respectively. Cost for medication procurement was significantly lower for gentian violet versus NYS (median $2.51 and 19.42, respectively, P = 0.01). Efficacy of gentian violet was not statistically different than NYS, was well tolerated, and its procurement cost was substantially less than NYS.

Topical gentian violet compared to nystatin oral suspension for the treatment of oropharyngeal candidiasis in HIV-1 Infected participants

PubMed Central

Mukherjee, Pranab K; Chen, Huichao; Patton, Lauren L; Evans, Scott; Lee, Anthony; Kumwenda, Johnstone; Hakim, James; Masheto, Gaerolwe; Sawe, Frederick; Pho, Mai T; Freedberg, Kenneth A; Shiboski, Caroline H; Ghannoum, Mahmoud A; Salata, Robert A

2016-01-01

Objective Compare the safety and efficacy of topical gentian violet (GV) to that of nystatin oral suspension (NYS) for the treatment of oropharyngeal candidiasis (OC) in HIV-1 infected adults in resource-limited settings. Design Multicenter, open-label, evaluator-blinded, randomized clinical trial at 8 international sites, within the AIDS Clinical Trials Group. Study participants and Intervention Adult HIV-infected participants with OC, stratified by CD4 cell counts and antiretroviral therapy status at study entry, were randomized to receive either GV (0.00165%, BID) or NYS (500,000 units, QID) for 14 days. Main outcome measure(s) Cure or improvement after 14 days of treatment. Signs and symptoms of OC were evaluated in an evaluator-blinded manner. Results The study was closed early per DSMB after enrolling 221 participants (target = 494). Among the 182 participants eligible for efficacy analysis, 63 (68.5%) in the GV arm had cure or improvement of OC versus 61 (67.8%) in the NYS arm, resulting in a non-sizable difference of 0.007 (95% CI: -0.129, 0.143). There was no sizable difference in cure rates between the two arms (-0.0007; 95% CI: -0.146, 0.131). No GV-related adverse events were noted. No sizable differences were identified in tolerance, adherence, quality of life, or acceptability of study drugs. In GV arm, 61% and 39% of participants reported “no” and “mild-to-moderate” staining, respectively. Cost for medication procurement was significantly lower for GV versus NYS [Median $2.51 and $19.42, respectively, P = 0.01]. Conclusions Efficacy of GV was not statistically different than NYS, was well-tolerated, and its procurement cost was substantially less than NYS. PMID:27677161

Basal deposits and drusen in eyes with age-related maculopathy: evidence for solid lipid particles.

PubMed

Curcio, Christine A; Presley, J Brett; Millican, C Leigh; Medeiros, Nancy E

2005-06-01

Neutral lipid, including esterified cholesterol, and apolipoproteins B and E are abundant in basal deposits and drusen of aged and age-related maculopathy (ARM) eyes. The principal component of basal linear deposit (BlinD), a specific ARM lesion, is membranous debris, which if actually derived from membranes cannot account for extracellular neutral lipid. We therefore used a lipid-preserving ultrastructural method to obtain improved images of membranous debris. Maculas from 44 human donors (71-96 yr) were preserved <7.5 hr after death. Blocks were post-fixed in 2% osmium or osmium-tannic acid-paraphenylenediamine (OTAP) to preserve neutral lipid for thin-section transmission electron microscopic (TEM) examination. Solid particles identified by OTAP were considered closest to the in vivo state of extracellular lipids. Micrographs were examined for intermediate forms, with greatest weight given to comparable images from different preparations of same or fellow eyes. Twenty eyes of older adults (12 with ARM including fellows treated with photodynamic and radiation therapies) had adequately preserved extracellular lipid. The exterior surface of membranous debris was thicker and more electron-dense than basal infoldings of retinal pigment epithelium (RPE) cells. By OTAP, individual membranous debris profiles were solid (diameters, 80-200 nm) and formed tracks across or aggregations within basal laminar deposits. Solid particles and/or pools of neutral lipid were visible in BlinD and drusen. When processed to preserve lipid, membranous debris resembles neither membranes of surrounding cells nor vesicles possessing aqueous interiors but rather solid particles. These results are consistent with recent evidence implicating lipoprotein particles of intra-ocular origin as a potential source of neutral lipids, including esterified cholesterol, in the specific lesions of ARM.

The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial.

PubMed

Guétin, Stéphane; Giniès, Patrick; Siou, Didier Kong A; Picot, Marie-Christine; Pommié, Christelle; Guldner, Elisabeth; Gosp, Anne-Marie; Ostyn, Katelyne; Coudeyre, Emmanuel; Touchon, Jacques

2012-05-01

A music intervention method in the management of pain was recently developed while taking account of recommendations in the scientific literature. The objective of this study was to assess the usefulness of this music intervention to the management of patients with chronic pain. A controlled, single-blind, randomized trial was used. Eighty-seven patients presenting with lumbar pain, fibromyalgia, inflammatory disease, or neurological disease were included in the study. During their hospitalization, the intervention arm (n=44) received at least 2 daily sessions of music listening between D0 and D10, associated with their standard treatment, and then pursued the music intervention at home until D60 using a multimedia player in which the music listening software program had been installed. The control arm received standard treatment only (n=43). The end points measured at D0, D10, D60, and D90 were: pain (VAS), anxiety-depression (HAD) and the consumption of medication. At D60 in the music intervention arm, this technique enabled a more significant reduction (P<0.001) in pain (6.3 ± 1.7 at D0 vs. 3 ± 1.7 at D60) when compared with the arm without music intervention (6.2 ± 1.5 at D0 vs. 4.6 ± 1.7 at D60). In addition, music intervention contributed to significantly reducing both anxiety/depression and the consumption of anxiolytic agents. These results confirm the value of music intervention to the management of chronic pain and anxiety/depression. This music intervention method appears to be useful in managing chronic pain as it enables a significant reduction in the consumption of medication.

Isometric arm counter-pressure maneuvers to abort impending vasovagal syncope.

PubMed

Brignole, Michele; Croci, Francesco; Menozzi, Carlo; Solano, Alberto; Donateo, Paolo; Oddone, Daniele; Puggioni, Enrico; Lolli, Gino

2002-12-04

We hypothesized that isometric arm exercises were able to increase blood pressure (BP) during the phase of impending vasovagal syncope and allow the patient to avoid losing consciousness. Hypotension is always present during the prodromal phase of vasovagal syncope. We evaluated the effect of handgrip (HG) and arm-tensing in 19 patients affected by tilt-induced vasovagal syncope. The study consisted of an acute single-blind, placebo-controlled, randomized, cross-over tilt-table efficacy study and a clinical follow-up feasibility study. In the acute tilt study, HG was administered for 2 min, starting at the time of onset of symptoms of impending syncope. In the active arm, HG caused an increase in systolic blood pressure (SBP) from 92 +/- 10 mm Hg to 105 +/- 38 mm Hg, whereas in the placebo arm SBP decreased from 91 +/- 11 mm Hg to 73 +/- 21 mm Hg (p = 0.008). Heart rate behavior was similar in the two arms. In the active arm, 63% of patients became asymptomatic, versus 11% in the control arm (p = 0.02); conversely, only 5% of patients developed syncope, versus 47% in the control arm (p = 0.01). The patients were trained to self-administer arm-tensing treatment as soon as symptoms of impending syncope occurred. During 9 +/- 3 months of follow-up, the treatment was actually performed in 95/97 episodes of impending syncope (98%) and was successful in 94/95 (99%). No patients suffered injury or other adverse morbidity related to the relapses. Isometric arm contraction is able to abort impending vasovagal syncope by increasing systemic BP. Arm counter-pressure maneuvers can be proposed as a new, feasible, safe, and well accepted first-line treatment for vasovagal syncope.

Overview on Deaf-Blindness

ERIC Educational Resources Information Center

Miles, Barbara

2008-01-01

It may seem that deaf-blindness refers to a total inability to see or hear. However, in reality deaf-blindness is a condition in which the combination of hearing and visual losses in children cause "such severe communication and other develop mental and educational needs that they cannot be accommodated in special education programs solely for…

Attenuation of Change Blindness in Children with Autism Spectrum Disorders

ERIC Educational Resources Information Center

Fletcher-Watson, Sue; Leekam, Susan R.; Connolly, Brenda; Collis, Jess M.; Findlay, John M.; McConachie, Helen; Rodgers, Jacqui

2012-01-01

Change blindness refers to the difficulty most people find in detecting a difference between two pictures when these are presented successively, with a brief interruption between. Attention at the site of the change is required for detection. A number of studies have investigated change blindness in adults and children with autism spectrum…

Prevalence and causes of severe visual impairment and blindness among children in the lorestan province of iran, using the key informant method.

PubMed

Razavi, Hessom; Kuper, Hannah; Rezvan, Farhad; Amelie, Khatere; Mahboobi-Pur, Hassan; Oladi, Mohammad Reza; Muhit, Mohammad; Hashemi, Hassan

2010-03-01

To estimate the prevalence and causes of severe visual impairment and blindness among children in Lorestan province of Iran, and to assess the feasibility of the Key Informant Method in this setting. Potential cases were identified using the Key Informant Method, in 3 counties of Lorestan province during June through August 2008, and referred for examination. Causes of severe visual impairment/blindness were determined and categorized using standard World Health Organization methods. Of 123 children referred for examination, 27 children were confirmed to have severe visual impairment/blindness or blindness. The median age was11 years (interquartile range 6-13), and 59% were girls. After adjusting for non-attenders, the estimated prevalence of severe visual impairment/blindness was 0.04% (0.03-0.05). The main site of abnormality was retina (44%), followed by disorders of the whole eye (33%). The majority of causes had a hereditary etiology (70%), which was associated with a family history of blindness (P = 0.002). Potentially avoidable causes of severe visual impairment/blindness were found in 14 children (52%). Almost all children with severe visual impairment/blindness had a history of parental consanguinity (93%). Our findings suggest a moderate prevalence of childhood blindness in the Lorestan province of Iran, a high proportion of which may be avoidable, given improved access to ophthalmic and genetic counselling services in rural areas. The Key Informant Method is feasible in Iran; future research is discussed.

Color vision test

MedlinePlus

... present from birth) color vision problems: Achromatopsia -- complete color blindness , seeing only shades of gray Deuteranopia -- difficulty telling ... Vision test - color; Ishihara color vision test Images Color blindness tests References Bowling B. Hereditary fundus dystrophies. In: ...

Do open label blinded outcome studies of novel anticoagulants versus warfarin have equivalent validity to those carried out under double-blind conditions?

PubMed

O'Neil, William M; Welner, Sharon A; Lip, Gregory Y H

2013-03-01

Recent anticoagulants for stroke prevention in AF have been tested in active comparator controlled studies versus warfarin using two designs: double-blind, double-dummy and prospective randomised, open blinded endpoint (PROBE). The former requires elaborate procedures to maintain blinding, while PROBE does not. Outcomes of double-blind and PROBE designed studies of novel anticoagulants for AF, focusing on warfarin controls, were explored. Major, Phase III warfarin-controlled trials for stroke prevention in AF were identified. Odds ratios (ORs) of key outcomes for active comparators versus VKA and event rates for VKA arms were compared between designs, in context of baseline demographics and inclusion criteria. Identified trials studied five novel anticoagulants in three each of PROBE and double-blind design. For ORs of results across studies and outcomes, there was little pattern differentiating the two designs. Among VKA-control subjects, event rates for the primary outcome (stroke or systemic embolism) in PROBE trials at 1.74 %/year (95% confidence interval: 1.54-1.95) was not significantly different from that in double-blind trials, at 1.88 (1.73-2.03). Among other outcomes, VKA-treated subjects in both trial designs had similar event rates, apart from higher all-cause mortality in ROCKET AF, and lower myocardial infarction rates among the PROBE study patients. Although there are differences in outcome between PROBE and double blind trials, they do not appear to be design-related. The exacting requirements of double-blinding in AF trials may not be necessary.

Control method and system for hydraulic machines employing a dynamic joint motion model

DOEpatents

Danko, George [Reno, NV

2011-11-22

A control method and system for controlling a hydraulically actuated mechanical arm to perform a task, the mechanical arm optionally being a hydraulically actuated excavator arm. The method can include determining a dynamic model of the motion of the hydraulic arm for each hydraulic arm link by relating the input signal vector for each respective link to the output signal vector for the same link. Also the method can include determining an error signal for each link as the weighted sum of the differences between a measured position and a reference position and between the time derivatives of the measured position and the time derivatives of the reference position for each respective link. The weights used in the determination of the error signal can be determined from the constant coefficients of the dynamic model. The error signal can be applied in a closed negative feedback control loop to diminish or eliminate the error signal for each respective link.

A cluster design controlled trial of arts-based observational skills training in primary care.

PubMed

Kirklin, Deborah; Duncan, Jane; McBride, Sandy; Hunt, Sam; Griffin, Mark

2007-04-01

To investigate whether the observational skills of doctors and nurses can be improved by arts-based observational skills training. We carried out a cluster design, controlled trial involving 42 general practitioners and 26 primary care nurses in 12 primary care practices in London. Six practices were allocated to the intervention arm and 6 to the control arm. The intervention group received 90 minutes of arts-based observational skills training. The control group received practical training in the management of psoriasis. Before and after this, control and intervention participants were asked to describe 3 dermatological photographs. Descriptions were scored blindly against a predetermined marking key. Participants completed a questionnaire about the intervention, and about their own confidence in diagnosing and referring suspicious pigmented skin lesions. Post-intervention scores were significantly higher in the intervention group compared with the control group (P < 0.001). The majority of participants judged the intervention relevant, enjoyable and valuable. A majority lacked confidence in their dermatological knowledge and skills. This study provides statistically significant evidence that arts-based observational skills training can improve the observational skills of doctors and nurses. It is important not to overstate the clinical significance of these findings, and to recognise that observational skills are just one of many complex and subtle factors affecting the quality of the clinical process. Further research is needed to assess the existence, nature and clinical significance of longer-term benefits, and to identify differences between professional groups.

Gd-EOB-DTPA-enhanced magnetic resonance imaging for focal liver lesions in Chinese patients: a multicenter, open-label, phase III study.

PubMed

Zeng, Meng-Su; Ye, Hui-Yi; Guo, Liang; Peng, Wei-Jun; Lu, Jian-Ping; Teng, Gao-Jun; Huan, Yi; Li, Ping; Xu, Jian-Rong; Liang, Chang-Hong; Breuer, Josy

2013-12-01

Contrast agents help to improve visibility in magnetic resonance (MR) imaging. However, owing to the large interstitial spaces of the liver, there is a reduction in the natural contrast gradient between lesions and healthy tissue. This study was undertaken to evaluate the efficacy and safety of the liver-specific MR imaging contrast agent gadoxetate disodium (Gd-EOB-DTPA) in Chinese patients. This was a single-arm, open-label, multicenter study in patients with known or suspected focal liver lesions referred for contrast-enhanced MR imaging. MR imaging was performed in 234 patients before and after a single intravenous bolus of Gd-EOB-DTPA (0.025 mmol/kg body weight). Images were evaluated by clinical study investigators and three independent, blinded radiologists. The primary efficacy endpoint was sensitivity in lesion detection. Gd-EOB-DTPA improved sensitivity in lesion detection by 9.46% compared with pre-contrast imaging for the average of the three blinded readers (94.78% vs 85.32% for Gd-EOB-DTPA vs pre-contrast, respectively). Improvements in detection were more pronounced in lesions less than 1 cm. Gd-EOB-DTPA improved diagnostic accuracy in lesion classification. This open-label study demonstrated that Gd-EOB-DTPA improves diagnostic sensitivity in liver lesions, particularly in those smaller than 1 cm. Gd-EOB-DTPA also significantly improves the diagnostic accuracy in lesion classification, and furthermore, Gd-EOB-DTPA is safe in Chinese patients with liver lesions.

The multiple personalities of Watson and Crick strands.

PubMed

Cartwright, Reed A; Graur, Dan

2011-02-08

In genetics it is customary to refer to double-stranded DNA as containing a "Watson strand" and a "Crick strand." However, there seems to be no consensus in the literature on the exact meaning of these two terms, and the many usages contradict one another as well as the original definition. Here, we review the history of the terminology and suggest retaining a single sense that is currently the most useful and consistent. The Saccharomyces Genome Database defines the Watson strand as the strand which has its 5'-end at the short-arm telomere and the Crick strand as its complement. The Watson strand is always used as the reference strand in their database. Using this as the basis of our standard, we recommend that Watson and Crick strand terminology only be used in the context of genomics. When possible, the centromere or other genomic feature should be used as a reference point, dividing the chromosome into two arms of unequal lengths. Under our proposal, the Watson strand is standardized as the strand whose 5'-end is on the short arm of the chromosome, and the Crick strand as the one whose 5'-end is on the long arm. Furthermore, the Watson strand should be retained as the reference (plus) strand in a genomic database. This usage not only makes the determination of Watson and Crick unambiguous, but also allows unambiguous selection of reference stands for genomics. This article was reviewed by John M. Logsdon, Igor B. Rogozin (nominated by Andrey Rzhetsky), and William Martin.

Effects of Bladder Training and Pelvic Floor Muscle Training in Female Patients with Overactive Bladder Syndrome: A Randomized Controlled Trial.

PubMed

Rizvi, Raheela Mohsin; Chughtai, Novera Ghayoor; Kapadia, Naheed

2018-01-01

The purpose of our study was to see the efficacy of 3 different modes of treatment for overactive bladder (OAB) in symptoms reduction and quality of life improvement. We conducted a 12-week single-blinded randomized controlled trial of women aged 22-65 years with clinical diagnosis of OAB. Arm A (n = 47) received bladder training, arm B (n = 50) received pelvic floor muscle training (PFMT), and arm C (n = 50) received PFMT with biofeedback. Bladder diary was used to assess the difference in urinary frequency, urgency, and leak accidents before and after treatment. Initial and final assessment was made using -validated urogenital distress inventory short form 6 (UDI-SF6) and incontinence impact questionnaire short form 7 (IIQ-SF7). UDI-SF6 scores showed significant improvement in all arms. There was a reduction in UDI-6 scores from 8.38 ± 4.3 to 4.77 ± 5.5 with a mean difference of 3.61 ± 7.4 in patients in arm A (p = 0.002), arm B (p = 0.01), and arm C (p = 0.016). All patients in arms A, B, and C reported significant improvement in quality of life as assessed by IIQ-SF7 scores with significant p values of 0.009, 0.051, and 0.001, respectively. Bladder diary results using paired t test showed the significant difference in day time urinary frequency in arm A after treatment, as well as the reduction in both leak accidents and urgency score in all 3 arms. All 3 arms of study showed significant results and can be used as the first line of management. © 2018 S. Karger AG, Basel.

Armed Forces and National Development in the Case of the Republic of Indonesia

DTIC Science & Technology

1990-03-01

DEVELOPMENT ........... 9 E. THE TARGETS OF NATIONAL DEVELOPMENT ............. 9 Ill. THE HISTORY OF THE INDONESIAN ARMED FORCES .......... 13 A. THE...stability in the economics and politics of Taiwan. Similarly, in the course of history of the nation’s struggle to uphold the proclamation of independence...common history , tradition and culture. Development refers to socio- demographic, structural, and value changes from traditional to modem. It also refers

Plasma trimethylamine-N-oxide following supplementation with vitamin D or D plus B vitamins.

PubMed

Obeid, Rima; Awwad, Hussain M; Kirsch, Susanne H; Waldura, Christiane; Herrmann, Wolfgang; Graeber, Stefan; Geisel, Juergen

2017-02-01

We compared the effect of supplementation with vitamin D + B or vitamin D on plasma trimethylamine N-oxide (TMAO) and choline metabolites. This is a randomized single-blinded nonplacebo-controlled study. Twenty-seven participants received 1200 IU vitamin D3 and 800 mg calcium, and 25 participants received additionally 0.5 mg folic acid, 50 mg B6, and 0.5 mg B12 for 1 year. Plasma homocysteine (Hcy), TMAO, and choline metabolites were measured at baseline and 12 months later. TMAO declined in the vitamin D arm by 0.5 versus 2.8 μmol/L in the D + B arm (p = 0.005). Hcy decreased and betaine increased in the D + B compared to the D arm. Within-subject levels of plasma choline and dimethylglycine and urine betaine increased in both arms and changes did not differ between the arms. TMAO reduction was predicted by higher baseline TMAO and lowering Hcy in stepwise regression analysis. The test-retest variations of TMAO were greater in the D + B arm compared to vitamin D arm. B vitamins plus vitamin D lowered plasma fasting TMAO compared to vitamin D. Vitamin D caused alterations in choline metabolism, which may reflect the metabolic flexibility of C1-metabolism. The molecular mechanisms and health implications of these changes are currently unknown. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

A high-dose preparation of lactobacilli and bifidobacteria in the prevention of antibiotic-associated and Clostridium difficile diarrhoea in older people admitted to hospital: a multicentre, randomised, double-blind, placebo-controlled, parallel arm trial (PLACIDE).

PubMed

Allen, S J; Wareham, K; Wang, D; Bradley, C; Sewell, B; Hutchings, H; Harris, W; Dhar, A; Brown, H; Foden, A; Gravenor, M B; Mack, D; Phillips, C J

2013-12-01

Antibiotic-associated diarrhoea (AAD) occurs most commonly in older people admitted to hospital and within 12 weeks of exposure to broad-spectrum antibiotics. Although usually a mild and self-limiting illness, the 15-39% of cases caused by Clostridium difficile infection [C. difficile diarrhoea (CDD)] may result in severe diarrhoea and death. Previous research has shown that probiotics, live microbial organisms that, when administered in adequate numbers, are beneficial to health, may be effective in preventing AAD and CDD. To determine the clinical effectiveness and cost-effectiveness of a high-dose, multistrain probiotic in the prevention of AAD and CDD in older people admitted to hospital. A multicentre, randomised, double-blind, placebo-controlled, parallel-arm trial. Medical, surgical and elderly care inpatient wards in five NHS hospitals in the UK. Eligible patients were aged ≥ 65 years, were exposed to one or more oral or parenteral antibiotics and were without pre-existing diarrhoeal disorders, recent CDD or at risk of probiotic adverse effects. Out of 17,420 patients screened, 2981 (17.1%) were recruited. Participants were allocated sequentially according to a computer-generated random allocation sequence; 1493 (50.1%) were allocated to the probiotic and 1488 (49.9%) to the placebo arm. Vegetarian capsules containing two strains of lactobacilli and two strains of bifidobacteria (a total of 6 × 10(10) organisms per day) were taken daily for 21 days. The placebo was inert maltodextrin powder in identical capsules. The occurrence of AAD within 8 weeks and CDD within 12 weeks of recruitment was determined by participant follow-up and checking hospital laboratory records by research nurses who were blind to arm allocation. Analysis based on the treatment allocated included 2941 (98.7%) participants. Potential risk factors for AAD at baseline were similar in the two study arms. Frequency of AAD (including CDD) was similar in the probiotic (159/1470, 10.8%) and placebo arms [153/1471, 10.4%; relative risk (RR) 1.04; 95% confidence interval (CI) 0.84 to 1.28; p = 0.71]. CDD was an uncommon cause of AAD and occurred in 12/1470 (0.8%) participants in the probiotic and 17/1471 (1.2%) in the placebo arm (RR 0.71; 95% CI 0.34 to 1.47; p = 0.35). Duration and severity of diarrhoea, common gastrointestinal symptoms, serious adverse events and quality of life measures were also similar in the two arms. Total health-care costs per patient did not differ significantly between the probiotic (£8020; 95% CI £7620 to £8420) and placebo (£8010; 95% CI £7600 to £8420) arms. We found no evidence that probiotic administration was effective in preventing AAD. Although there was a trend towards reduced CDD in the probiotic arm, on balance, the administration of this probiotic seems unlikely to benefit older patients exposed to antibiotics. A better understanding of the pathogenesis of AAD and CDD and the strain-specific effects of probiotics is needed before further clinical trials of specific microbial preparations are undertaken. Evaluation of the effectiveness of other probiotics will be difficult where other measures, such as antibiotic stewardship, have reduced CDD rates. This trial is registered as ISRCTN70017204. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 17, No. 57. See the NIHR Journals Library website for further project information.

Communication style and exercise compliance in physiotherapy (CONNECT): a cluster randomized controlled trial to test a theory-based intervention to increase chronic low back pain patients' adherence to physiotherapists' recommendations: study rationale, design, and methods.

PubMed

Lonsdale, Chris; Hall, Amanda M; Williams, Geoffrey C; McDonough, Suzanne M; Ntoumanis, Nikos; Murray, Aileen; Hurley, Deirdre A

2012-06-15

Physical activity and exercise therapy are among the accepted clinical rehabilitation guidelines and are recommended self-management strategies for chronic low back pain. However, many back pain sufferers do not adhere to their physiotherapist's recommendations. Poor patient adherence may decrease the effectiveness of advice and home-based rehabilitation exercises. According to self-determination theory, support from health care practitioners can promote patients' autonomous motivation and greater long-term behavioral persistence (e.g., adherence to physiotherapists' recommendations). The aim of this trial is to assess the effect of an intervention designed to increase physiotherapists' autonomy-supportive communication on low back pain patients' adherence to physical activity and exercise therapy recommendations. This study will be a single-blinded cluster randomized controlled trial. Outpatient physiotherapy centers (N =12) in Dublin, Ireland (population = 1.25 million) will be randomly assigned using a computer-generated algorithm to either the experimental or control arm. Physiotherapists in the experimental arm (two hospitals and four primary care clinics) will attend eight hours of communication skills training. Training will include handouts, workbooks, video examples, role-play, and discussion designed to teach physiotherapists how to communicate in a manner that promotes autonomous patient motivation. Physiotherapists in the waitlist control arm (two hospitals and four primary care clinics) will not receive this training. Participants (N = 292) with chronic low back pain will complete assessments at baseline, as well as 1 week, 4 weeks, 12 weeks, and 24 weeks after their first physiotherapy appointment. Primary outcomes will include adherence to physiotherapy recommendations, as well as low back pain, function, and well-being. Participants will be blinded to treatment allocation, as they will not be told if their physiotherapist has received the communication skills training. Outcome assessors will also be blinded.We will use linear mixed modeling to test between arm differences both in the mean levels and the rates of change of the outcome variables. We will employ structural equation modeling to examine the process of change, including hypothesized mediation effects. This trial will be the first to test the effect of a self-determination theory-based communication skills training program for physiotherapists on their low back pain patients' adherence to rehabilitation recommendations.

Novel retinopathy in related Gordon setters: a clinical, behavioral, electrophysiological, and genetic investigation.

PubMed

Good, Kathryn L; Komáromy, András M; Kass, Philip H; Ofri, Ron

2016-09-01

To conduct ophthalmic, behavioral, electrophysiological, and genetic testing on two related Gordon setters presented for day blindness and compare findings with those of nine related and unrelated Gordon setters. All dogs underwent comprehensive ophthalmic examination. Maze testing was conducted under different light intensities. Rod and cone function was assessed electroretinographically. DNA samples were screened for five canine retinal disease gene mutations. Ophthalmic examination was unremarkable in all dogs. There was no notable difference between day blind dogs and the reference population in scotopic and mesopic maze tests. Day blind dogs performed worse in the photopic maze with slower course completion time and more obstacle collisions. Electroretinography revealed extinguished cone function in day blind dogs and depressed rod responses in all but two reference dogs. One reference population dog presented with day blindness 1 year after initial examination. Mutations that cause achromatopsia (in CNGB3) and cone-rod dystrophies (in ADAM9 and IQCB1) were not detected in any dog tested, although five reference dogs were carriers of the mutation in C2orf71 that causes rod-cone degeneration 4 (rcd4) in Gordon setters and in polski owczarek nizinny dogs. This report describes a novel retinopathy in related Gordon setters that has clinical signs and vision testing results consistent with achromatopsia but electroretinographic results suggestive of cone-rod dystrophy. The majority of Gordon setters in this study had low rod responses on electroretinography but it is unclear whether this was indicative of rod dysfunction or normal for the breed. Longer-term observation of affected individuals is warranted. © 2015 American College of Veterinary Ophthalmologists.

Gas Sensors Based on Single-Arm Waveguide Interferometers

NASA Technical Reports Server (NTRS)

Sarkisov, Sergey; Curley, Michael; Diggs, Darnell; Adamovsky, Grigory

1998-01-01

Various optical technologies can be implemented in chemical sensing. Sensitive, rugged, and compact systems will be more likely built using interferometric waveguide sensors. Currently existing sensors comprise dual-arm systems with external reference arm, dual-arm devices with internal reference arm such as integrated Mach-Zehnder interferometer, and single-arm systems which employ the interference between different waveguide modes. These latter ones are the most compact and rugged but still sensitive enough to monitor volatile pollutants such as NH3 coming out of industrial refrigerators and fertilizer plants and stocks, NO, NO2, SO2, emitted by industrial burning processes. Single-arm devices in planar waveguide configuration most frequently use two orthogonally polarized modes TE (sub i) and TM (sub i) of the same order i. Sensing effect is based on the difference in propagation conditions for the modes caused by the environment. However, dual-mode single-order interferometers still have relatively low sensitivity with respect to the environment related changes in the waveguide core because of small difference between propagation constants of TE (sub i) and TM (sub i) modes of the same order. Substantial sensitivity improvement without significant complication can be achieved for planar waveguide interferometers using modes of different orders with much greater difference between propagation constants.

The South Asian Origins of the Global Network to Eradicate Blindness: WHO, NGOs, and Decentralization.

PubMed

Williams, Logan D A

2018-03-01

The global network to eradicate blindness emerged out of the work of Western and South Asian professionals to eradicate smallpox which was endemic in South Asia. The history of the emergence of the global network to eradicate blindness demonstrates a shift from vertical command and control public health programs directed by the WHO, to the decentralized public health services originating in non-profit, non-governmental organizations and coordinated by the WHO. The WHO constitution started with a federal regionalist structure that encouraged collaboration and coordination with NGOs. In South Asia in particular, epidemiologists and general medical practitioners moved from eradicating smallpox through the WHO to creating their own domestic and international NGOs based in various countries with a mission to control blindness in South Asia and Africa. In 1975, pushed by the WHO Director General, these new NGOs in turn joined with individual ophthalmologists and existing blind member associations to form the International Agency for the Prevention of Blindness. Thus, the WHO was shaped by, and shaping, international NGOs such as the IAPB. The IAPB pushed for the formation of the WHO Prevention of Blindness program. This was the earliest example of how the IAPB facilitates bottom-up agenda-setting in the WHO. In 1980, when the WHO officially closed the smallpox program, the Prevention of Blindness program first received independent funding. Presently, the IAPB acts as a decentralized arm of the WHO. Copyright © 2018 Elsevier Ltd. All rights reserved.

Accelerometry Measuring the Outcome of Robot-Supported Upper Limb Training in Chronic Stroke: A Randomized Controlled Trial

PubMed Central

Lemmens, Ryanne J. M.; Timmermans, Annick A. A.; Janssen-Potten, Yvonne J. M.; Pulles, Sanne A. N. T. D.; Geers, Richard P. J.; Bakx, Wilbert G. M.; Smeets, Rob J. E. M.; Seelen, Henk A. M.

2014-01-01

Purpose This study aims to assess the extent to which accelerometers can be used to determine the effect of robot-supported task-oriented arm-hand training, relative to task-oriented arm-hand training alone, on the actual amount of arm-hand use of chronic stroke patients in their home situation. Methods This single-blind randomized controlled trial included 16 chronic stroke patients, randomly allocated using blocked randomization (n = 2) to receive task-oriented robot-supported arm-hand training or task-oriented (unsupported) arm-hand training. Training lasted 8 weeks, 4 times/week, 2×30 min/day using the (T-)TOAT ((Technology-supported)-Task-Oriented-Arm-Training) method. The actual amount of arm-hand use, was assessed at baseline, after 8 weeks training and 6 months after training cessation. Duration of use and intensity of use of the affected arm-hand during unimanual and bimanual activities were calculated. Results Duration and intensity of use of the affected arm-hand did not change significantly during and after training, with or without robot-support (i.e. duration of use of unimanual use of the affected arm-hand: median difference of −0.17% in the robot-group and −0.08% in the control group between baseline and after training cessation; intensity of the affected arm-hand: median difference of 3.95% in the robot-group and 3.32% in the control group between baseline and after training cessation). No significant between-group differences were found. Conclusions Accelerometer data did not show significant changes in actual amount of arm-hand use after task-oriented training, with or without robot-support. Next to the amount of use, discrimination between activities performed and information about quality of use of the affected arm-hand are essential to determine actual arm-hand performance. Trial Registration Controlled-trials.com ISRCTN82787126 PMID:24823925

Telephone-Based Physical Activity Counseling for Major Depression in People with Multiple Sclerosis

ERIC Educational Resources Information Center

Bombardier, Charles H.; Ehde, Dawn M.; Gibbons, Laura E.; Wadhwani, Roini; Sullivan, Mark D.; Rosenberg, Dori E.; Kraft, George H.

2013-01-01

Objective: Physical activity represents a promising treatment for major depressive disorder (MDD) in people with multiple sclerosis (MS). We conducted a single-blind, two-arm randomized controlled trial comparing a 12-week physical activity counseling intervention delivered primarily by telephone (n = 44) to a wait-list control group (N = 48).…

Locally Learning Biomedical Data Using Diffusion Frames

DTIC Science & Technology

2012-01-01

age - related macular degeneration (AMD) patients. All eye- related data were collected by our collaborators at the...in Table 2. 6.2. Age - related macular degeneration Age - related macular degeneration is the most common cause of blindness among the elderly population...maculopathy and age - related macular degeneration . The international ARM epidemiological study group. Surv. Ophthalmol. 39, 367–374.

Next-generation sequencing analysis of the ARMS2 gene in Turkish exudative age-related macular degeneration patients.

PubMed

Bardak, H; Gunay, M; Ercalik, Y; Bardak, Y; Ozbas, H; Bagci, O

2017-01-23

Age-related macular degeneration (AMD) is the leading cause of blindness in developed countries. It is a complex disease with both genetic and environmental risk factors. To improve clinical management of this condition, it is important to develop risk assessment and prevention strategies for environmental influences, and establish a more effective treatment approach. The aim of the present study was to investigate age-related maculopathy susceptibility protein 2 (ARMS2) gene sequences among Turkish patients with exudative AMD. In addition to 39 advanced exudative AMD patients, 250 healthy individuals for whom exome sequencing data were available were included as a control group. Patients with a history of known environmental and systemic AMD risk factors were excluded. Genomic DNA was isolated from peripheral blood and analyzed using next-generation sequencing. All coding exons of the ARMS2 gene were assessed. Three different ARMS2 sequence variations (rs10490923, rs2736911, and rs10490924) were identified in both the patient and control group. Within the control group, two further ARMS2 gene variants (rs7088128 and rs36213074) were also detected. Logistic regression analysis revealed a relationship between the rs10490924 polymorphism and AMD in the Turkish population.

Trial of Early Aggressive Therapy in Polyarticular Juvenile Idiopathic Arthritis

PubMed Central

Wallace, Carol A.; Giannini, Edward H.; Spalding, Steven J.; Hashkes, Philip J.; O’Neil, Kathleen M.; Zeft, Andrew S.; Szer, Ilona S.; Ringold, Sarah; Brunner, Hermine I.; Schanberg, Laura E.; Sundel, Robert P.; Milojevic, Diana; Punaro, Marilynn G.; Chira, Peter; Gottlieb, Beth S.; Higgins, Gloria C.; Ilowite, Norman T.; Kimura, Yukiko; Hamilton, Stephanie; Johnson, Anne; Huang, Bin; Lovell, Daniel J.

2011-01-01

OBJECTIVES To determine if aggressive treatment initiated early in the course of rheumatoid factor positive or negative polyarticular juvenile idiopathic arthritis (poly-JIA) can induce clinical inactive disease (CID) within 6 months. METHODS Between May 2007 and October 2010 a multi-center, prospective, double blind, randomized, placebo controlled trial of two aggressive treatments was conducted in 85 children aged 2 to 16 years with polyarticular JIA of less than 12 months duration. Patients received either methotrexate 0.5 mg/kg/wk SQ (40 mg max), etanercept 0.8 mg/kg/wk (50 mg max), prednisolone 0.5 mg/kg/d (60 mg max) tapered to 0 by 17 weeks (Arm 1), or methotrexate (same dose as Arm 1), etanercept placebo, and prednisolone placebo (Arm 2). The primary outcome was CID at 6 months. An exploratory phase determined the rate of clinical remission on medication (6 months of continuous CID) at 12 months. RESULTS By 6 months, 17 of 42 (40%) of patients in Arm 1 and 10 of 43 (23%) in Arm 2 had achieved CID (X2 = 2.91; p = 0.088). After 12 months, 9 patients in Arm 1 and 3 in Arm 2 achieved clinical remission on medication (p = 0.0534). There were no significant inter-arm differences in adverse events. CONCLUSIONS Although this study did not meet its primary endpoint, early aggressive therapy in this cohort of children with recent onset polyarticular JIA resulted in substantial proportions of patients in both arms achieving CID by 6 months and clinical remission on medication within 12 months of treatment. PMID:22183975

A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II.

PubMed

Christiansen, Mark P; Klaff, Leslie J; Brazg, Ronald; Chang, Anna R; Levy, Carol J; Lam, David; Denham, Douglas S; Atiee, George; Bode, Bruce W; Walters, Steven J; Kelley, Lynne; Bailey, Timothy S

2018-03-01

Persistent use of real-time continuous glucose monitoring (CGM) improves diabetes control in individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D). PRECISE II was a nonrandomized, blinded, prospective, single-arm, multicenter study that evaluated the accuracy and safety of the implantable Eversense CGM system among adult participants with T1D and T2D (NCT02647905). The primary endpoint was the mean absolute relative difference (MARD) between paired Eversense and Yellow Springs Instrument (YSI) reference measurements through 90 days postinsertion for reference glucose values from 40 to 400 mg/dL. Additional endpoints included Clarke Error Grid analysis and sensor longevity. The primary safety endpoint was the incidence of device-related or sensor insertion/removal procedure-related serious adverse events (SAEs) through 90 days postinsertion. Ninety participants received the CGM system. The overall MARD value against reference glucose values was 8.8% (95% confidence interval: 8.1%-9.3%), which was significantly lower than the prespecified 20% performance goal for accuracy (P < 0.0001). Ninety-three percent of CGM values were within 20/20% of reference values over the total glucose range of 40-400 mg/dL. Clarke Error Grid analysis showed 99.3% of samples in the clinically acceptable error zones A (92.8%) and B (6.5%). Ninety-one percent of sensors were functional through day 90. One related SAE (1.1%) occurred during the study for removal of a sensor. The PRECISE II trial demonstrated that the Eversense CGM system provided accurate glucose readings through the intended 90-day sensor life with a favorable safety profile.

Position sense at the human elbow joint measured by arm matching or pointing.

PubMed

Tsay, Anthony; Allen, Trevor J; Proske, Uwe

2016-10-01

Position sense at the human elbow joint has traditionally been measured in blindfolded subjects using a forearm matching task. Here we compare position errors in a matching task with errors generated when the subject uses a pointer to indicate the position of a hidden arm. Evidence from muscle vibration during forearm matching supports a role for muscle spindles in position sense. We have recently shown using vibration, as well as muscle conditioning, which takes advantage of muscle's thixotropic property, that position errors generated in a forearm pointing task were not consistent with a role by muscle spindles. In the present study we have used a form of muscle conditioning, where elbow muscles are co-contracted at the test angle, to further explore differences in position sense measured by matching and pointing. For fourteen subjects, in a matching task where the reference arm had elbow flexor and extensor muscles contracted at the test angle and the indicator arm had its flexors conditioned at 90°, matching errors lay in the direction of flexion by 6.2°. After the same conditioning of the reference arm and extension conditioning of the indicator at 0°, matching errors lay in the direction of extension (5.7°). These errors were consistent with predictions based on a role by muscle spindles in determining forearm matching outcomes. In the pointing task subjects moved a pointer to align it with the perceived position of the hidden arm. After conditioning of the reference arm as before, pointing errors all lay in a more extended direction than the actual position of the arm by 2.9°-7.3°, a distribution not consistent with a role by muscle spindles. We propose that in pointing muscle spindles do not play the major role in signalling limb position that they do in matching, but that other sources of sensory input should be given consideration, including afferents from skin and joint.

Alcohol and Other Drug Abuse as Coexisting Disabilities: Considerations for Counselors Serving Individuals Who Are Blind or Visually Impaired.

ERIC Educational Resources Information Center

Koch, D. Shane; Nelipovich, Michael; Sneed, Zach

2002-01-01

This article identifies the potential affect of alcohol and other drug abuse (AODA) on people who are blind or visually impaired, the barriers to providing effective AODA services for those people, and strategies for improving services for people with coexisting blindness or visual impairments and AODA. (Contains references.) (CR)

Improvements to GOES Twilight Cloud Detection over the ARM SGP

NASA Technical Reports Server (NTRS)

Yost, c. R.; Trepte, Q.; Khaiyer, M. M.; Palikonda, R.; Nguyen, L.

2007-01-01

The current ARM satellite cloud products derived from Geostationary Operational Environmental Satellite (GOES) data provide continuous coverage of many cloud properties over the ARM Southern Great Plains domain. However, discontinuities occur during daylight near the terminator, a time period referred to here as twilight. This poster presentation will demonstrate the improvements in cloud detection provided by the improved cloud mask algorithm as well as validation of retrieved cloud properties using surface observations from the Atmospheric Radiation Measurement Southern Great Plains (ARM SGP) site.

Forming positive-negative images using conditioned partial measurements from reference arm in ghost imaging.

PubMed

Wen, Jianming

2012-09-01

A recent thermal ghost imaging experiment implemented in Wu's group [Chin. Phys. Lett. 279, 074216 (2012)] showed that both positive and negative images can be constructed by applying a novel algorithm. This algorithm allows us to form the images with the use of partial measurements from the reference arm (even which never passes through the object), conditioned on the object arm. In this paper, we present a simple theory that explains the experimental observation and provides an in-depth understanding of conventional ghost imaging. In particular, we theoretically show that the visibility of formed images through such an algorithm is not bounded by the standard value 1/3. In fact, it can ideally grow up to unity (with reduced imaging quality). Thus, the algorithm described here not only offers an alternative way to decode spatial correlation of thermal light, but also mimics a "bandpass filter" to remove the constant background such that the visibility or imaging contrast is improved. We further show that conditioned on one still object present in the test arm, it is possible to construct the object's image by sampling the available reference data.

The multiple personalities of Watson and Crick strands

PubMed Central

2011-01-01

Background In genetics it is customary to refer to double-stranded DNA as containing a "Watson strand" and a "Crick strand." However, there seems to be no consensus in the literature on the exact meaning of these two terms, and the many usages contradict one another as well as the original definition. Here, we review the history of the terminology and suggest retaining a single sense that is currently the most useful and consistent. Proposal The Saccharomyces Genome Database defines the Watson strand as the strand which has its 5'-end at the short-arm telomere and the Crick strand as its complement. The Watson strand is always used as the reference strand in their database. Using this as the basis of our standard, we recommend that Watson and Crick strand terminology only be used in the context of genomics. When possible, the centromere or other genomic feature should be used as a reference point, dividing the chromosome into two arms of unequal lengths. Under our proposal, the Watson strand is standardized as the strand whose 5'-end is on the short arm of the chromosome, and the Crick strand as the one whose 5'-end is on the long arm. Furthermore, the Watson strand should be retained as the reference (plus) strand in a genomic database. This usage not only makes the determination of Watson and Crick unambiguous, but also allows unambiguous selection of reference stands for genomics. Reviewers This article was reviewed by John M. Logsdon, Igor B. Rogozin (nominated by Andrey Rzhetsky), and William Martin. PMID:21303550

Which cuff should I use? Indirect blood pressure measurement for the diagnosis of hypertension in patients with obesity: a diagnostic accuracy review.

PubMed

Irving, Greg; Holden, John; Stevens, Richard; McManus, Richard J

2016-11-03

To determine the diagnostic accuracy of different methods of blood pressure (BP) measurement compared with reference standards for the diagnosis of hypertension in patients with obesity with a large arm circumference. Systematic review with meta-analysis with hierarchical summary receiver operating characteristic models. Bland-Altman analyses where individual patient data were available. Methodological quality appraised using Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS2) criteria. MEDLINE, EMBASE, Cochrane, DARE, Medion and Trip databases were searched. Cross-sectional, randomised and cohort studies of diagnostic test accuracy that compared any non-invasive BP tests (upper arm, forearm, wrist, finger) with an appropriate reference standard (invasive BP, correctly fitting upper arm cuff, ambulatory BP monitoring) in primary care were included. 4037 potentially relevant papers were identified. 20 studies involving 26 different comparisons met the inclusion criteria. Individual patient data were available from 4 studies. No studies satisfied all QUADAS2 criteria. Compared with the reference test of invasive BP, a correctly fitting upper arm BP cuff had a sensitivity of 0.87 (0.79 to 0.93) and a specificity of 0.85 (0.64 to 0.95); insufficient evidence was available for other comparisons to invasive BP. Compared with the reference test of a correctly fitting upper arm cuff, BP measurement at the wrist had a sensitivity of 0.92 (0.64 to 0.99) and a specificity of 0.92 (0.85 to 0.87). Measurement with an incorrectly fitting standard cuff had a sensitivity of 0.73 (0.67 to 0.78) and a specificity of 0.76 (0.69 to 0.82). Measurement at the forearm had a sensitivity of 0.84 (0.71 to 0.92) and a specificity 0.75 of (0.66 to 0.83). Bland-Altman analysis of individual patient data from 3 studies comparing wrist and upper arm BP showed a mean difference of 0.46 mm Hg for systolic BP measurement and 2.2 mm Hg for diastolic BP measurement. BP measurement with a correctly fitting upper arm cuff is sufficiently sensitive and specific to diagnose hypertension in patients with obesity with a large upper arm circumference. If a correctly fitting upper arm cuff cannot be applied, an incorrectly fitting standard size cuff should not be used and BP measurement at the wrist should be considered. 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/.

Which cuff should I use? Indirect blood pressure measurement for the diagnosis of hypertension in patients with obesity: a diagnostic accuracy review

PubMed Central

Holden, John

2016-01-01

Objective To determine the diagnostic accuracy of different methods of blood pressure (BP) measurement compared with reference standards for the diagnosis of hypertension in patients with obesity with a large arm circumference. Design Systematic review with meta-analysis with hierarchical summary receiver operating characteristic models. Bland-Altman analyses where individual patient data were available. Methodological quality appraised using Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS2) criteria. Data sources MEDLINE, EMBASE, Cochrane, DARE, Medion and Trip databases were searched. Eligibility criteria Cross-sectional, randomised and cohort studies of diagnostic test accuracy that compared any non-invasive BP tests (upper arm, forearm, wrist, finger) with an appropriate reference standard (invasive BP, correctly fitting upper arm cuff, ambulatory BP monitoring) in primary care were included. Results 4037 potentially relevant papers were identified. 20 studies involving 26 different comparisons met the inclusion criteria. Individual patient data were available from 4 studies. No studies satisfied all QUADAS2 criteria. Compared with the reference test of invasive BP, a correctly fitting upper arm BP cuff had a sensitivity of 0.87 (0.79 to 0.93) and a specificity of 0.85 (0.64 to 0.95); insufficient evidence was available for other comparisons to invasive BP. Compared with the reference test of a correctly fitting upper arm cuff, BP measurement at the wrist had a sensitivity of 0.92 (0.64 to 0.99) and a specificity of 0.92 (0.85 to 0.87). Measurement with an incorrectly fitting standard cuff had a sensitivity of 0.73 (0.67 to 0.78) and a specificity of 0.76 (0.69 to 0.82). Measurement at the forearm had a sensitivity of 0.84 (0.71 to 0.92) and a specificity 0.75 of (0.66 to 0.83). Bland-Altman analysis of individual patient data from 3 studies comparing wrist and upper arm BP showed a mean difference of 0.46 mm Hg for systolic BP measurement and 2.2 mm Hg for diastolic BP measurement. Conclusions BP measurement with a correctly fitting upper arm cuff is sufficiently sensitive and specific to diagnose hypertension in patients with obesity with a large upper arm circumference. If a correctly fitting upper arm cuff cannot be applied, an incorrectly fitting standard size cuff should not be used and BP measurement at the wrist should be considered. PMID:27810973

Reference Books in Special Media. Reference Circular No. 82-4.

ERIC Educational Resources Information Center

Library of Congress, Washington, DC. National Library Service for the Blind and Physically Handicapped.

Based on information contained in producers' catalogs and on responses to a survey conducted by the Reference Section of the Library of Congress National Library Service (NLS) for the Blind and Physically Handicapped, this publication lists reference materials produced in braille or in large type, and sound recordings of reference works available…

X-linked recessive primary retinal dysplasia is linked to the Norrie disease locus.

PubMed

Ravia, Y; Braier-Goldstein, O; Bat-Miriam, K M; Erlich, S; Barkai, G; Goldman, B

1993-08-01

X-linked primary retinal dysplasia (PRD) refers to an abnormal proliferation of retinal tissue causing either its neural elements or its glial tissue to form folds, giving rise to gliosis. A Jewish family of oriental origin was previously reported by Godel and Goodman, in which a total of five males suffer from different degrees of blindness. The authors postulated that the described findings are distinguished from Norrie disease, since in this case no clinical findings, other than those associated with the eyes, were noticed in the affected males. In addition, two of the carrier females exhibit minimal eye changes. We have performed linkage analysis of the family using the L1.28, p58-1 and m27 beta probes, and DXS426 and MAOB associated microsatellites. Our results map the gene responsible for the disorder between the MAOB and DXS426, m27 beta and p58-1 loci, on the short arm of the X chromosome at Xp11.3, which suggest the possibility that the same gene is responsible for both primary retinal dysplasia and Norrie disease.

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 ).

A blinded, randomized controlled trial of high-dose vitamin D supplementation to reduce recurrence of bacterial vaginosis.

PubMed

Turner, Abigail Norris; Carr Reese, Patricia; Fields, Karen S; Anderson, Julie; Ervin, Melissa; Davis, John A; Fichorova, Raina N; Roberts, Mysheika Williams; Klebanoff, Mark A; Jackson, Rebecca D

2014-11-01

Low serum vitamin D levels have been associated with increased prevalence of the reproductive tract condition bacterial vaginosis (BV). The objective of this trial was to evaluate the effect of high-dose vitamin D supplementation on BV recurrence. This randomized, placebo-controlled, double-blinded trial enrolled 118 women with symptomatic BV from an urban sexually transmitted disease clinic (clinicaltrials.gov registration NCT01450462). All participants received 500 mg of oral metronidazole twice daily for 7 days. Intervention participants (n = 59) also received 9 doses of 50,000 IU of cholecalciferol (vitamin D3) over 24 weeks; control women (n = 59) received matching placebo. Recurrent BV was assessed via Nugent scoring after 4, 12, and 24 weeks. We assessed the effect of the intervention using an intention-to-treat approach, fitting Cox proportional hazards models to evaluate recurrent BV over the follow-up period. Most participants (74%) were black, with a median age of 26 years. Median presupplementation serum 25-hydroxyvitamin D [25(OH)D] was similar across randomization arms: 16.6 ng/mL in the vitamin D arm and 15.8 ng/mL in the control arm. At trial completion, median 25(OH)D among women receiving vitamin D was 30.5 ng/mL, vs 17.8 ng/mL in control women; 16% of women receiving vitamin D and 57% receiving placebo remained vitamin D deficient (<20 ng/mL). BV prevalence among women randomized to vitamin D was very similar to those randomized to placebo at the 4- and 12-week visits, but by the 24-week visit, BV prevalence was 65% among women in the vitamin D arm and 48% among control women. BV recurrence was not reduced by vitamin D supplementation (intention-to-treat hazard ratio, 1.11; 95% confidence interval, 0.68-1.81). Among women experiencing recurrent BV, median time to recurrence was 13.7 weeks in the vitamin D arm and 14.3 weeks in the control arm. Women receiving vitamin D experienced significant increases in serum 25(OH)D, but this increase was not associated with decreased BV recurrence in this high-risk sexually transmitted disease clinic population. Copyright © 2014 Elsevier Inc. All rights reserved.

A blinded, randomized controlled trial of high-dose vitamin D supplementation to reduce recurrence of bacterial vaginosis

PubMed Central

TURNER, Abigail Norris; REESE, Patricia CARR; FIELDS, Karen S.; ANDERSON, Julie; ERVIN, Melissa; DAVIS, John A.; FICHOROVA, Raina N.; ROBERTS, Mysheika Williams; KLEBANOFF, Mark A.; JACKSON, Rebecca D.

2014-01-01

Objective Low serum vitamin D levels have been associated with increased prevalence of the reproductive tract condition bacterial vaginosis (BV). The objective of this trial was to evaluate the effect of high-dose vitamin D supplementation on BV recurrence. Study design This randomized, placebo-controlled, double-blinded trial enrolled 118 women with symptomatic BV from an urban STD clinic (clinicaltrials.gov registration NCT01450462). All participants received 500mg oral metronidazole twice daily for seven days. Intervention participants (n=59) also received nine doses of 50,000 international units of cholecalciferol (vitamin D3) over 24 weeks; control women (n=59) received matching placebo. Recurrent BV was assessed via Nugent scoring after 4, 12 and 24 weeks. We assessed the effect of the intervention using an intention-to-treat approach, fitting Cox proportional hazards models to evaluate recurrent BV over the follow-up period. Results Most participants (74%) were black, with a median age of 26 years. Median presupplementation serum 25-hydroxyvitamin D [25(OH)D] was similar across randomization arms: 16.6 ng/mL in the vitamin D arm and 15.8 ng/mL in the control arm. At trial completion, median 25(OH)D among women receiving vitamin D was 30.5 ng/mL, vs 17.8 ng/mL in control women; 16% of women receiving vitamin D and 57% receiving placebo remained vitamin D deficient (<20 ng/mL). BV prevalence among women randomized to vitamin D was very similar to those randomized to placebo at the 4- and 12-week visits, but by the 24-week visit, BV prevalence was 65% among women in the vitamin D arm and 48% among control women. BV recurrence was not reduced by vitamin D supplementation (intention-to-treat hazard ratio, 1.11; 95% confidence interval, 0.68-1.81). Among women experiencing recurrent BV, median time to recurrence was 13.7 weeks in the vitamin D arm and 14.3 weeks in the control arm. Conclusions Women receiving vitamin D experienced significant increases in serum 25(OH)D, but this increase was not associated with decreased BV recurrence in this high-risk STD clinic population. PMID:24949544

Carbon dioxide insufflation during colonoscopy in deeply sedated patients

PubMed Central

Singh, Rajvinder; Neo, Eu Nice; Nordeen, Nazree; Shanmuganathan, Ganesananthan; Ashby, Angelie; Drummond, Sharon; Nind, Garry; Murphy, Elizabeth; Luck, Andrew; Tucker, Graeme; Tam, William

2012-01-01

AIM: To compare the impact of carbon dioxide (CO2) and air insufflation on patient tolerance/safety in deeply sedated patients undergoing colonoscopy. METHODS: Patients referred for colonoscopy were randomized to receive either CO2 or air insufflation during the procedure. Both the colonoscopist and patient were blinded to the type of gas used. During the procedure, insertion and withdrawal times, caecal intubation rates, total sedation given and capnography readings were recorded. The level of sedation and magnitude of patient discomfort during the procedure was assessed by a nurse using a visual analogue scale (VAS) (0-3). Patients then graded their level of discomfort and abdominal bloating using a similar VAS. Complications during and after the procedure were recorded. RESULTS: A total of 142 patients were randomized with 72 in the air arm and 70 in the CO2 arm. Mean age between the two study groups were similar. Insertion time to the caecum was quicker in the CO2 group at 7.3 min vs 9.9 min with air (P = 0.0083). The average withdrawal times were not significantly different between the two groups. Caecal intubation rates were 94.4% and 100% in the air and CO2 groups respectively (P = 0.012). The level of discomfort assessed by the nurse was 0.69 (air) and 0.39 (CO2) (P = 0.0155) and by the patient 0.82 (air) and 0.46 (CO2) (P = 0.0228). The level of abdominal bloating was 0.97 (air) and 0.36 (CO2) (P = 0.001). Capnography readings trended to be higher in the CO2 group at the commencement, caecal intubation, and conclusion of the procedure, even though this was not significantly different when compared to readings obtained during air insufflation. There were no complications in both arms. CONCLUSION: CO2 insufflation during colonoscopy is more efficacious than air, allowing quicker and better cecal intubation rates. Abdominal discomfort and bloating were significantly less with CO2 insufflation. PMID:22783048

Carbon dioxide insufflation during colonoscopy in deeply sedated patients.

PubMed

Singh, Rajvinder; Neo, Eu Nice; Nordeen, Nazree; Shanmuganathan, Ganesananthan; Ashby, Angelie; Drummond, Sharon; Nind, Garry; Murphy, Elizabeth; Luck, Andrew; Tucker, Graeme; Tam, William

2012-07-07

To compare the impact of carbon dioxide (CO₂) and air insufflation on patient tolerance/safety in deeply sedated patients undergoing colonoscopy. Patients referred for colonoscopy were randomized to receive either CO₂ or air insufflation during the procedure. Both the colonoscopist and patient were blinded to the type of gas used. During the procedure, insertion and withdrawal times, caecal intubation rates, total sedation given and capnography readings were recorded. The level of sedation and magnitude of patient discomfort during the procedure was assessed by a nurse using a visual analogue scale (VAS) (0-3). Patients then graded their level of discomfort and abdominal bloating using a similar VAS. Complications during and after the procedure were recorded. A total of 142 patients were randomized with 72 in the air arm and 70 in the CO₂ arm. Mean age between the two study groups were similar. Insertion time to the caecum was quicker in the CO₂ group at 7.3 min vs 9.9 min with air (P = 0.0083). The average withdrawal times were not significantly different between the two groups. Caecal intubation rates were 94.4% and 100% in the air and CO₂ groups respectively (P = 0.012). The level of discomfort assessed by the nurse was 0.69 (air) and 0.39 (CO₂) (P = 0.0155) and by the patient 0.82 (air) and 0.46 (CO₂) (P = 0.0228). The level of abdominal bloating was 0.97 (air) and 0.36 (CO₂) (P = 0.001). Capnography readings trended to be higher in the CO₂ group at the commencement, caecal intubation, and conclusion of the procedure, even though this was not significantly different when compared to readings obtained during air insufflation. There were no complications in both arms. CO₂ insufflation during colonoscopy is more efficacious than air, allowing quicker and better cecal intubation rates. Abdominal discomfort and bloating were significantly less with CO₂ insufflation.

Chemical micro-sensor

DOEpatents

Ruggiero, Anthony J.

2005-05-03

An integrated optical capillary electrophoresis system for analyzing an analyte. A modulated optical pump beam impinges on an capillary containing the analyte/buffer solution which is separated by electrophoresis. The thermally-induced change in the index of refraction of light in said electrophoresis capillary is monitored using an integrated micro-interferometer. The interferometer includes a first interferometer arm intersecting the electrophoresis capillary proximate the excitation beam and a second, reference interferometer arm. Changes in index of refraction in the analyte measured by interrogating the interferometer state using white light interferometry and a phase-generated carrier demodulation technique. Background thermo-optical activity in the buffer solution is cancelled by splitting the pump beam and exciting pure buffer solution in a second section of capillary where it crosses the reference arm of the interferometer.

Utility and Cost-Effectiveness of Motivational Messaging to Increase Survey Response in Physicians: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Chan, Randolph C. H.; Mak, Winnie W. S.; Pang, Ingrid H. Y.; Wong, Samuel Y. S.; Tang, Wai Kwong; Lau, Joseph T. F.; Woo, Jean; Lee, Diana T. F.; Cheung, Fanny M.

2018-01-01

The present study examined whether, when, and how motivational messaging can boost the response rate of postal surveys for physicians based on Higgin's regulatory focus theory, accounting for its cost-effectiveness. A three-arm, blinded, randomized controlled design was used. A total of 3,270 doctors were randomly selected from the registration…

Efficacy of Atorvastatin in Prevention of Contrast-induced Nephropathy in High-risk Patients Undergoing Angiography: A Double-blind Randomized Controlled Trial.

PubMed

Syed, Maaz Hussain; Khandelwal, Prakash Narayan; Thawani, Vijay R; Katare, S S

2017-01-01

To evaluate the efficacy and safety of atorvastatin (ATN) 80 mg in the prevention of contrast medium- induced nephropathy (CIN) in high risk patients undergoing angiograph. This was a prospective, double-blind, two-arm, parallel group RCT. A total of 216 patients undergoing coronary angiography were screened, and 188 eligible patients were randomized to two treatment arms. Patients in Group A received tablet N-acetylcysteine (NAC) 1200 mg once daily, and patients in Group B received tablet atorvastatin 80 mg + NAC 1200 mg once daily, for 3 days before, and 2 days after angiography. A total of 160 patients completed the trial. Postprocedure, nine and two CIN cases were found in Group A and B, respectively. The mean change in serum creatinine was 0.086 ± 0.168 in Group A and 0.021 ± 0.083 in Group B, which was statistically significant ( P = 0.0289). Postprocedure, the estimated glomerular filteration rate was reduced by 19.52 in Group A and 13.55 in Group B ( P = 0.003). This trial indicates the positive role of statins in preventive strategy against CIN along with NAC.

Efficacy of Atorvastatin in Prevention of Contrast-induced Nephropathy in High-risk Patients Undergoing Angiography: A Double-blind Randomized Controlled Trial

PubMed Central

Syed, Maaz Hussain; Khandelwal, Prakash Narayan; Thawani, Vijay R.; Katare, S. S.

2017-01-01

Objective: To evaluate the efficacy and safety of atorvastatin (ATN) 80 mg in the prevention of contrast medium- induced nephropathy (CIN) in high risk patients undergoing angiograph. Materials and Methods: This was a prospective, double-blind, two-arm, parallel group RCT. A total of 216 patients undergoing coronary angiography were screened, and 188 eligible patients were randomized to two treatment arms. Patients in Group A received tablet N-acetylcysteine (NAC) 1200 mg once daily, and patients in Group B received tablet atorvastatin 80 mg + NAC 1200 mg once daily, for 3 days before, and 2 days after angiography. Results: A total of 160 patients completed the trial. Postprocedure, nine and two CIN cases were found in Group A and B, respectively. The mean change in serum creatinine was 0.086 ± 0.168 in Group A and 0.021 ± 0.083 in Group B, which was statistically significant (P = 0.0289). Postprocedure, the estimated glomerular filteration rate was reduced by 19.52 in Group A and 13.55 in Group B (P = 0.003). Conclusion: This trial indicates the positive role of statins in preventive strategy against CIN along with NAC. PMID:28706398

L-arginine and Vitamin D Adjunctive Therapies in Pulmonary Tuberculosis: A Randomised, Double-Blind, Placebo-Controlled Trial

PubMed Central

Ralph, Anna P.; Waramori, Govert; Pontororing, Gysje J.; Kenangalem, Enny; Wiguna, Andri; Tjitra, Emiliana; Sandjaja; Lolong, Dina B.; Yeo, Tsin W.; Chatfield, Mark D.; Soemanto, Retno K.; Bastian, Ivan; Lumb, Richard; Maguire, Graeme P.; Eisman, John; Price, Ric N.; Morris, Peter S.; Kelly, Paul M.; Anstey, Nicholas M.

2013-01-01

Background Vitamin D (vitD) and L-arginine have important antimycobacterial effects in humans. Adjunctive therapy with these agents has the potential to improve outcomes in active tuberculosis (TB). Methods In a 4-arm randomised, double-blind, placebo-controlled factorial trial in adults with smear-positive pulmonary tuberculosis (PTB) in Timika, Indonesia, we tested the effect of oral adjunctive vitD 50,000 IU 4-weekly or matching placebo, and L-arginine 6.0 g daily or matching placebo, for 8 weeks, on proportions of participants with negative 4-week sputum culture, and on an 8-week clinical score (weight, FEV1, cough, sputum, haemoptysis). All participants with available endpoints were included in analyses according to the study arm to which they were originally assigned. Adults with new smear-positive PTB were eligible. The trial was registered at ClinicalTrials.gov NCT00677339. Results 200 participants were enrolled, less than the intended sample size: 50 received L-arginine + active vitD, 49 received L-arginine + placebo vit D, 51 received placebo L-arginine + active vitD and 50 received placebo L-arginine + placebo vitD. According to the factorial model, 99 people received arginine, 101 placebo arginine, 101 vitamin D, 99 placebo vitamin D. Results for the primary endpoints were available in 155 (4-week culture) and 167 (clinical score) participants. Sputum culture conversion was achieved by week 4 in 48/76 (63%) participants in the active L-arginine versus 48/79 (61%) in placebo L-arginine arms (risk difference −3%, 95% CI −19 to 13%), and in 44/75 (59%) in the active vitD versus 52/80 (65%) in the placebo vitD arms (risk difference 7%, 95% CI −9 to 22%). The mean clinical outcome score also did not differ between study arms. There were no effects of the interventions on adverse event rates including hypercalcaemia, or other secondary outcomes. Conclusion Neither vitD nor L-arginine supplementation, at the doses administered and with the power attained, affected TB outcomes. Registry ClinicalTrials.gov. Registry number: NCT00677339 PMID:23967066

Effect of homeopathy on analgesic intake following knee ligament reconstruction: a phase III monocentre randomized placebo controlled study

PubMed Central

Paris, A; Gonnet, N; Chaussard, C; Belon, P; Rocourt, F; Saragaglia, D; Cracowski, J L

2008-01-01

Aims The efficacy of homeopathy is still under debate. The objective of this study was to assess the efficacy of homeopathic treatment (Arnica montana 5 CH, Bryonia alba 5 CH, Hypericum perforatum 5 CH and Ruta graveolens 3 DH) on cumulated morphine intake delivered by PCA over 24 h after knee ligament reconstruction. Methods This was an add-on randomized controlled study with three parallel groups: a double-blind homeopathic or placebo arm and an open-label noninterventional control arm. Eligible patients were 18–60 years old candidates for surgery of the anterior cruciate ligament. Treatment was administered the evening before surgery and continued for 3 days. The primary end-point was cumulated morphine intake delivered by PCA during the first 24 h inferior or superior/equal to 10 mg day−1. Results One hundred and fifty-eight patients were randomized (66 in the placebo arm, 67 in the homeopathic arm and 25 in the noninterventional group). There was no difference between the treated and the placebo group for primary end-point (mean (95% CI) 48% (35.8, 56.3), and 56% (43.7, 68.3), required less than 10 mg day−1 of morphine in each group, respectively). The homeopathy treatment had no effect on morphine intake between 24 and 72 h or on the visual analogue pain scale, or on quality of life assessed by the SF-36 questionnaire. In addition, these parameters were not different in patients enrolled in the open-label noninterventional control arm. Conclusions The complex of homeopathy tested in this study was not superior to placebo in reducing 24 h morphine consumption after knee ligament reconstruction. What is already known about this subject The efficacy of homeopathy is still under debate and a recent meta-analysis recommended further randomized double-blind clinical trials to identify any clinical situation in which homeopathy might be effective. What this study adds The complex of homeopathy tested in this study (Arnica montana 5 CH, Bryonia alba 5 CH, Hypericum perforatum 5 CH and Ruta graveolens 3 DH) is not superior to placebo in reducing 24 h morphine consumption after knee ligament reconstruction. PMID:18251757

Prospective randomized double-blind multicentre phase II study comparing gemcitabine and cisplatin plus sorafenib chemotherapy with gemcitabine and cisplatin plus placebo in locally advanced and/or metastasized urothelial cancer: SUSE (AUO-AB 31/05).

PubMed

Krege, Susanne; Rexer, Heidrun; vom Dorp, Frank; de Geeter, Patrick; Klotz, Theodor; Retz, Margitte; Heidenreich, Axel; Kühn, Michael; Kamradt, Joern; Feyerabend, Susan; Wülfing, Christian; Zastrow, Stefan; Albers, Peter; Hakenberg, Oliver; Roigas, Jan; Fenner, Martin; Heinzer, Hans; Schrader, Mark

2014-03-01

To evaluate the efficacy and safety of gemcitabine and cisplatin in combination with sorafenib, a tyrosine-kinase inhibitor, compared with chemotherapy alone as first-line treatment in advanced urothelial cancer. The study was a randomized phase II trial. Its primary aim was to show an improvement in progression-free survival (PFS) of 4.5 months by adding sorafenib to conventional chemotherapy. Secondary objectives were objective response rate (ORR), overall survival (OS) and toxicity. The patients included in the trial had histologically confirmed locally advanced and/or metastatic urothelial cancer of the bladder or upper urinary tract. Chemotherapy with gemcitabine (1250 mg/qm on days 1 and 8) and cisplatin (70 mg/qm on day 1) repeated every 21 days, was administered to all patients in a double-blind randomization of additional sorafenib (400 mg twice daily) vs placebo (two tablets twice daily) on days 3-21. Treatment continued until progression or unacceptable toxicity, the maximum number of cycles was limited to eight. The response assessment was repeated after every two cycles. Between October 2006 and October 2010, 98 of 132 planned patients were recruited. Nine patients were ineligible. The final analysis included 40 patients in the sorafenib and 49 patients in the placebo arm. There were no significant differences between the two arms concerning ORR (sorafenib: complete response [CR] 12.5%, partial response [PR] 40%; placebo: CR 12%, PR 35%), median PFS (sorafenib: 6.3 months, placebo: 6.1 months) or OS (sorafenib: 11.3 months, placebo: 10.6 months). Toxicity was moderately higher in the sorafenib arm. Diarrrhoea occurred significantly more often in the sorafenib arm and hand-foot syndrome occurred only in the sorafenib arm. The study was closed prematurely because of slow recruitment. Although the addition of sorafenib to standard chemotherapy showed acceptable toxicity, the trial failed to show a 4.5 months improvement in PFS. © 2013 The Authors. BJU International © 2013 BJU International.

L-arginine and vitamin D adjunctive therapies in pulmonary tuberculosis: a randomised, double-blind, placebo-controlled trial.

PubMed

Ralph, Anna P; Waramori, Govert; Pontororing, Gysje J; Kenangalem, Enny; Wiguna, Andri; Tjitra, Emiliana; Sandjaja; Lolong, Dina B; Yeo, Tsin W; Chatfield, Mark D; Soemanto, Retno K; Bastian, Ivan; Lumb, Richard; Maguire, Graeme P; Eisman, John; Price, Ric N; Morris, Peter S; Kelly, Paul M; Anstey, Nicholas M

2013-01-01

Vitamin D (vitD) and L-arginine have important antimycobacterial effects in humans. Adjunctive therapy with these agents has the potential to improve outcomes in active tuberculosis (TB). In a 4-arm randomised, double-blind, placebo-controlled factorial trial in adults with smear-positive pulmonary tuberculosis (PTB) in Timika, Indonesia, we tested the effect of oral adjunctive vitD 50,000 IU 4-weekly or matching placebo, and L-arginine 6.0 g daily or matching placebo, for 8 weeks, on proportions of participants with negative 4-week sputum culture, and on an 8-week clinical score (weight, FEV1, cough, sputum, haemoptysis). All participants with available endpoints were included in analyses according to the study arm to which they were originally assigned. Adults with new smear-positive PTB were eligible. The trial was registered at ClinicalTrials.gov NCT00677339. 200 participants were enrolled, less than the intended sample size: 50 received L-arginine + active vitD, 49 received L-arginine + placebo vit D, 51 received placebo L-arginine + active vitD and 50 received placebo L-arginine + placebo vitD. According to the factorial model, 99 people received arginine, 101 placebo arginine, 101 vitamin D, 99 placebo vitamin D. Results for the primary endpoints were available in 155 (4-week culture) and 167 (clinical score) participants. Sputum culture conversion was achieved by week 4 in 48/76 (63%) participants in the active L-arginine versus 48/79 (61%) in placebo L-arginine arms (risk difference -3%, 95% CI -19 to 13%), and in 44/75 (59%) in the active vitD versus 52/80 (65%) in the placebo vitD arms (risk difference 7%, 95% CI -9 to 22%). The mean clinical outcome score also did not differ between study arms. There were no effects of the interventions on adverse event rates including hypercalcaemia, or other secondary outcomes. Neither vitD nor L-arginine supplementation, at the doses administered and with the power attained, affected TB outcomes. ClinicalTrials.gov. Registry number: NCT00677339.

Genetics Home Reference: autosomal dominant congenital stationary night blindness

MedlinePlus

... collapse boxes. Description Autosomal dominant congenital stationary night blindness is a disorder of the retina , which is the specialized tissue at the back of the eye that detects light and color. People with this condition typically have difficulty seeing ...

The effects of a home-based arm ergometry exercise programme on physical fitness, fatigue and activity in Polio survivors: a randomised controlled trial.

PubMed

Murray, D; Hardiman, O; Campion, A; Vance, R; Horgan, F; Meldrum, D

2017-07-01

To investigate the effect of an eight-week home-based arm ergometry aerobic exercise programme on physical fitness, fatigue, activity and quality of life in Polio Survivors. An assessor blinded randomised controlled trial. Home-based exercise. Fifty-five Polio survivors randomised to exercise or control groups. Home-based arm ergometry at an intensity of 50%-70% maximum heart rate, compared with usual physiotherapy care. The Six-minute Arm Test, Fatigue Severity Scale, Physical Activity Scale for Individuals with Physical Disabilities and SF-36. Assessments were completed at baseline and at eight weeks. There was no significant difference in the primary outcome, exercising heart rate during the Six-minute Arm Test, between the groups at follow-up [97.6 (SD10.1) compared to 102.4 (SD13.7) beats per minute ( P=0.20)]. Blood pressure was significantly lower in the intervention group at follow-up [systolic blood pressure 132(18.6)mmHg compared to 144.1(14.6)mmHg ( P=0.002)]. There were no between group differences in the Fatigue Severity Scale ( P=0.25) or Physical Activity Scale for Individuals with Physical Disabilities ( P=0.49), with a small difference in SF-36 physical component score ( P=0.04). This home-based arm ergometry programme successfully facilitated aerobic exercise in Polio Survivors, but did not result in a significant change in physical fitness, measured by the Six-minute Arm Test.

Versatile optical coherence tomography for imaging the human eye

PubMed Central

Tao, Aizhu; Shao, Yilei; Zhong, Jianguang; Jiang, Hong; Shen, Meixiao; Wang, Jianhua

2013-01-01

We demonstrated the feasibility of a CMOS-based spectral domain OCT (SD-OCT) for versatile ophthalmic applications of imaging the corneal epithelium, limbus, ocular surface, contact lens, crystalline lens, retina, and full eye in vivo. The system was based on a single spectrometer and an alternating reference arm with four mirrors. A galvanometer scanner was used to switch the reference beam among the four mirrors, depending on the imaging application. An axial resolution of 7.7 μm in air, a scan depth of up to 37.7 mm in air, and a scan speed of up to 70,000 A-lines per second were achieved. The approach has the capability to provide high-resolution imaging of the corneal epithelium, contact lens, ocular surface, and tear meniscus. Using two reference mirrors, the zero delay lines were alternatively placed on the front cornea or on the back lens. The entire ocular anterior segment was imaged by registering and overlapping the two images. The full eye through the pupil was measured when the reference arm was switched among the four reference mirrors. After mounting a 60 D lens in the sample arm, this SD-OCT was used to image the retina, including the macula and optical nerve head. This system demonstrates versatility and simplicity for multi-purpose ophthalmic applications. PMID:23847729

Cryolipolysis for Reduction of Arm Fat: Safety and Efficacy of a Prototype CoolCup Applicator With Flat Contour

PubMed Central

Humphrey, Shannon; Rivers, Jason K.

2017-01-01

BACKGROUND Cryolipolysis of the arms has been shown to be an effective but somewhat time-consuming process. OBJECTIVE The study evaluated safety and efficacy of a contoured cup cryolipolysis applicator for reduction of arm fat. The prototype was designed to maximize tissue contact with the cooling surface to improve comfort, while reducing treatment time by 25 minutes. MATERIALS AND METHODS Both arms were treated using a prototype device that delivered treatment in 35 minutes at −11°C. Photographic and ultrasound documentation was captured at baseline and 12 weeks post-treatment. Efficacy was assessed by photo review and measurement of fat reduction in ultrasound images. Immediately after 1, 4, and 12 weeks post-treatment, clinical assessments were performed to evaluate treatment areas and sensory alterations. RESULTS Thirty women were enrolled and completed treatments to both arms. Ultrasound measurements found mean fat layer reduction of 3.2 mm with an SD of 2.7 mm. Blinded independent photo review found 85.2% correct identification of baseline photographs by at least 2/3 of reviewers. There were no unanticipated adverse device effects. Four study subjects experienced numbness in the treatment area beyond the 12-week visit that subsequently resolved without intervention. CONCLUSION These data suggest that the CoolCup prototype applicator provides rapid, safe, and effective arm treatment. PMID:28595246

Repetitive facilitative exercise under continuous electrical stimulation for severe arm impairment after sub-acute stroke: a randomized controlled pilot study.

PubMed

Shimodozono, Megumi; Noma, Tomokazu; Matsumoto, Shuji; Miyata, Ryuji; Etoh, Seiji; Kawahira, Kazumi

2014-01-01

To investigate the effectiveness of repetitive facilitative exercise (RFE) under surface neuromuscular electrical stimulation (NMES) in patients with post-stroke hemiplegia. This randomized, controlled, observer-blinded, pilot trial randomized 27 adults with severe arm impairment [Fugl-Meyer Arm scale (FMA) ≤ 20] due to stroke of 3-13 weeks duration into three groups and provided treatment on a 4-week, 40 minutes/day, 5 days/week schedule. The RFE-under-NMES group were given 100-150 repetitions of standardized movements of shoulder, elbow and wrist joints of their affected arm with concurrent low-amplitude NMES for each corresponding musculature. The RFE group was given the same exercise regimen but without NMES. The control group was treated with a conventional arm rehabilitation programme without NMES. FMA was assessed at baseline and 4 weeks. All 27 participants (nine in each group) completed the trial. At 4 weeks, the RFE-under-NMES group evidenced significantly greater improvement compared with the control group on the FMA (p = 0.003), but not with the RFE group (p = 0.092). The RFE group showed improvement compared with the control group, but it was not significant (p = 0.199). RFE under NMES is feasible in clinical settings and may be more effective than conventional rehabilitation in lessening arm impairment after sub-acute stroke.

A randomized controlled study of socioeconomic support to enhance tuberculosis prevention and treatment, Peru

PubMed Central

Tovar, Marco A; Huff, Doug; Boccia, Delia; Montoya, Rosario; Ramos, Eric; Datta, Sumona; Saunders, Matthew J; Lewis, James J; Gilman, Robert H; Evans, Carlton A

2017-01-01

Abstract Objective To evaluate the impact of socioeconomic support on tuberculosis preventive therapy initiation in household contacts of tuberculosis patients and on treatment success in patients. Methods A non-blinded, household-randomized, controlled study was performed between February 2014 and June 2015 in 32 shanty towns in Peru. It included patients being treated for tuberculosis and their household contacts. Households were randomly assigned to either the standard of care provided by Peru’s national tuberculosis programme (control arm) or the same standard of care plus socioeconomic support (intervention arm). Socioeconomic support comprised conditional cash transfers up to 230 United States dollars per household, community meetings and household visits. Rates of tuberculosis preventive therapy initiation and treatment success (i.e. cure or treatment completion) were compared in intervention and control arms. Findings Overall, 282 of 312 (90%) households agreed to participate: 135 in the intervention arm and 147 in the control arm. There were 410 contacts younger than 20 years: 43% in the intervention arm initiated tuberculosis preventive therapy versus 25% in the control arm (adjusted odds ratio, aOR: 2.2; 95% confidence interval, CI: 1.1–4.1). An intention-to-treat analysis showed that treatment was successful in 64% (87/135) of patients in the intervention arm versus 53% (78/147) in the control arm (unadjusted OR: 1.6; 95% CI: 1.0–2.6). These improvements were equitable, being independent of household poverty. Conclusion A tuberculosis-specific, socioeconomic support intervention increased uptake of tuberculosis preventive therapy and tuberculosis treatment success and is being evaluated in the Community Randomized Evaluation of a Socioeconomic Intervention to Prevent TB (CRESIPT) project. PMID:28479622

Effects of sling and voluntary constraint during constraint-induced movement therapy for the arm after stroke: a randomized, prospective, single-centre, blinded observer rated study.

PubMed

Krawczyk, Maciej; Sidaway, Marta; Radwanska, Anna; Zaborska, Joanna; Ujma, Renata; Czlonkowska, Anna

2012-11-01

To determine whether a combination of constraint-induced movement therapy and physiotherapy in stroke patients using different constraint regimens (sling versus voluntary constraint) changes or reduces motor deficits, the amount of functional use of the arm and whether the effects of treatment continue after 12 months. Forty-seven stroke patients were stratified and randomly divided into intensive physiotherapy programmes focused on regaining arm functions. Neurorehabilitation Unit of IInd Department of Neurology at Institute of Psychiatry and Neurology in Warsaw. Patients were randomly allocated to: the sling-constraint group (n = 24) or to the voluntary-constraint group (n = 23). Massed practice with the paretic arm (5 hours/day for 15 consecutive working days). Sling-constraint group had their arm immobilized in a hemi-sling during therapy. In addition, individual, 1-hour physiotherapy sessions were conducted in both groups. Rivermead Motor Assessment (RMA) Arm scale, (0-15), Motor Activity Log - Quality of Movement (MAL-QOM) (0-5 for 30 daily tasks). There was no significant difference between groups after therapy (MAL-QOM mean change for sling group 0.78, SD = 0.46 and for voluntary-constraint group 0.84, SD = 0.48; P = 0.687). All treated patients retained mean gains in real-world arm use (MAL-QOM) mean scores after 12 months follow-up compared with posttreatment values but there was no significant difference between groups (comparison of estimated mean change of MAL-QOM stated 0.23. 95% confidence interval = -0.04-0.50). Voluntary activity constraint in the intact arm is equivalent to sling, standard constraint during massed practice of paretic arm.

A randomized controlled study of socioeconomic support to enhance tuberculosis prevention and treatment, Peru.

PubMed

Wingfield, Tom; Tovar, Marco A; Huff, Doug; Boccia, Delia; Montoya, Rosario; Ramos, Eric; Datta, Sumona; Saunders, Matthew J; Lewis, James J; Gilman, Robert H; Evans, Carlton A

2017-04-01

To evaluate the impact of socioeconomic support on tuberculosis preventive therapy initiation in household contacts of tuberculosis patients and on treatment success in patients. A non-blinded, household-randomized, controlled study was performed between February 2014 and June 2015 in 32 shanty towns in Peru. It included patients being treated for tuberculosis and their household contacts. Households were randomly assigned to either the standard of care provided by Peru's national tuberculosis programme (control arm) or the same standard of care plus socioeconomic support (intervention arm). Socioeconomic support comprised conditional cash transfers up to 230 United States dollars per household, community meetings and household visits. Rates of tuberculosis preventive therapy initiation and treatment success (i.e. cure or treatment completion) were compared in intervention and control arms. Overall, 282 of 312 (90%) households agreed to participate: 135 in the intervention arm and 147 in the control arm. There were 410 contacts younger than 20 years: 43% in the intervention arm initiated tuberculosis preventive therapy versus 25% in the control arm (adjusted odds ratio, aOR: 2.2; 95% confidence interval, CI: 1.1-4.1). An intention-to-treat analysis showed that treatment was successful in 64% (87/135) of patients in the intervention arm versus 53% (78/147) in the control arm (unadjusted OR: 1.6; 95% CI: 1.0-2.6). These improvements were equitable, being independent of household poverty. A tuberculosis-specific, socioeconomic support intervention increased uptake of tuberculosis preventive therapy and tuberculosis treatment success and is being evaluated in the Community Randomized Evaluation of a Socioeconomic Intervention to Prevent TB (CRESIPT) project.

Idelalisib or Placebo in Combination with Bendamustine and Rituximab in Patients with Relapsed/Refractory CLL - Interim Results of a Phase 3 Randomized, Double-blind Placebo-Controlled Trial

PubMed Central

Zelenetz, Andrew D.; Barrientos, Jacqueline C.; Brown, Jennifer R.; Coiffier, Bertrand; Delgado, Julio; Egyed, Miklós; Ghia, Paolo; Illés, Árpád; Jurczak, Wojciech; Marlton, Paula; Montillo, Marco; Morschhauser, Franck; Pristupa, Alexander S.; Robak, Tadeusz; Sharman, Jeff P.; Simpson, David; Smolej, Lukáš; Tausch, Eugen; Adewoye, Adeboye H.; Dreiling, Lyndah K.; Kim, Yeonhee; Stilgenbauer, Stephan; Hillmen, Peter

2017-01-01

Summary Background Bendamustine and rituximab (BR) has been a standard of care for the management of patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). We evaluated the efficacy and safety of adding idelalisib, a first-in-class targeted PI3Kδ inhibitor, to BR in patients with R/R CLL Methods This trial was a global, multicenter, double-blind, placebo -controlled trial in adult patients (≥18 years) with R/R CLL requiring treatment for their disease. Patients had to have measurable lymphadenopathy (≥1 nodal lesion ≥2.0 cm in the longest diameter and ≥1.0 cm in the longest perpendicular diameter) by computer tomography or magnetic resonance imaging, disease progression within <36 months since last prior therapy, a Karnofsky Performance Status score ≥60 and adequate bone marrow, liver and kidney function. Key exclusion criteria included histological transformation to an aggressive lymphoma (eg, Richter transformation) or disease refractory to bendamustine. Patients were randomised 1:1 using a central interactive web response system that assigned a unique treatment code for each patient, to receive intravenous BR infusions for a maximum of 6 cycles in addition to blinded study drug matching the assigned treatment of either twice-daily oral idelalisib 150 mg or placebo administered continuously until disease progression or intolerable study drug-related toxicity. Randomisation was stratified based on high-risk features (IGHV, del(17p)/TP53 mutation) and refractory vs relapsed disease. The primary endpoint was progression-free survival (PFS) assessed by an independent review committee in the intent-to-treat population. Overall survival was a key secondary endpoint. Crossover was not permitted to the idelalisib arm at progression. The trial is ongoing (ClinicalTrials.gov # NCT01569295). Findings Between 26 June 2012 and 21 August 2014, 416 patients with R/R CLL were enrolled; 207 patients were randomised to the idelalisib and 209 to the placebo arm. After the prespecified interim analysis, the Independent Data Monitoring Committee (IDMC) recommended discontinuation and unblinding of the trial due to efficacy. Updated data are presented in this manuscript with a cutoff date of 07 October 2015. Median (95% CI) PFS was 20·8 (16·6, 26·4) and 11·1 (8·9, 11·1) months in the idelalisib and placebo arms, respectively (hazard ratio [HR], 0·33; 95% CI, 0·25, 0·44; P<0·0001) at a median (Q1, Q3) follow-up of 14 (7, 18) months. The most frequent grade 3 or greater AEs were neutropenia (124/207 [60%]) and febrile neutropenia (48/207 [23%]) in the idelalisib arm and neutropenia (99/209 [47%]) and thrombocytopenia (27/209 [13%]) in the placebo arm. Serious AEs included febrile neutropenia, pneumonia and pyrexia and were common in both treatment arms. An increased risk of infection was observed in the idelalisib vs placebo arm. Interpretation Idelalisib plus BR is superior to BR alone, improving PFS and OS. This regimen represents an important new treatment option for patients with R/R CLL. PMID:28139405

Allocentric and contra-aligned spatial representations of a town environment in blind people.

PubMed

Chiesa, Silvia; Schmidt, Susanna; Tinti, Carla; Cornoldi, Cesare

2017-10-01

Evidence concerning the representation of space by blind individuals is still unclear, as sometimes blind people behave like sighted people do, while other times they present difficulties. A better understanding of blind people's difficulties, especially with reference to the strategies used to form the representation of the environment, may help to enhance knowledge of the consequences of the absence of vision. The present study examined the representation of the locations of landmarks of a real town by using pointing tasks that entailed either allocentric points of reference with mental rotations of different degrees, or contra-aligned representations. Results showed that, in general, people met difficulties when they had to point from a different perspective to aligned landmarks or from the original perspective to contra-aligned landmarks, but this difficulty was particularly evident for the blind. The examination of the strategies adopted to perform the tasks showed that only a small group of blind participants used a survey strategy and that this group had a better performance with respect to people who adopted route or verbal strategies. Implications for the comprehension of the consequences on spatial cognition of the absence of visual experience are discussed, focusing in particular on conceivable interventions. Copyright © 2017 Elsevier B.V. All rights reserved.

Comparison of Murraya koenigii- and Tribulus terrestris-based oral formulation versus tamsulosin in the treatment of benign prostatic hyperplasia in men aged >50 years: a double-blind, double-dummy, randomized controlled trial.

PubMed

Sengupta, Gairik; Hazra, Avijit; Kundu, Anup; Ghosh, Anirban

2011-12-01

Drug treatment can defer surgical intervention in benign prostatic hyperplasia (BPH), a common disorder in elderly men, and is widely practiced. Various herbal formulations have been used for the treatment of BPH, but few have been compared with established modern medicines in head-to-head clinical trials. We compared the effectiveness and tolerability of an oral formulation, comprising standardized extracts of Murraya koenigii and Tribulus terrestris leaves being marketed in India under Ayurvedic license, versus tamsulosin in the treatment of symptomatic BPH. A double-blind, double-dummy, parallel-group, randomized controlled trial was conducted with treatment-naive ambulatory patients with BPH aged >50 years. Patients received either the plant drug in a dose of 2 capsules BID or tamsulosin 400 μg once daily for 12 weeks with 2 interim follow-up visits at the end of 4 and 8 weeks. The double-dummy technique was used to ensure double-blinding. The primary effectiveness measure was reduction in the International Prostate Symptom Score (IPSS). Proportion of patients becoming completely or relatively symptom free (IPSS <8), change in prostate volume (assessed by using ultrasonography conducted by a radiologist blinded to the nature or duration of treatment), and peak urinary flow rate (assessed by using uroflowmetry) were secondary measures. Treatment-emergent adverse events, changes in weight, vital signs, and routine laboratory safety parameters were recorded. Forty-six patients were randomized (23 per group); 19 completed all study visits in the plant drug group and 21 in the tamsulosin group. However, applying modified intention-to-treat criterion, 23 and 21 patients, respectively, were considered for effectiveness analysis. Mean (SD) age and baseline weight were 58.5 (14.0) years and 57.5 (10.5) kg in the plant drug arm, and 62.9 (6.3) years and 59.8 (9.9) kg in the tamsulosin arm, respectively. Median (interquartile range) symptom duration was 12.0 (12.0-24.0) months and 15.0 (12.0-24.0) months, respectively, in the 2 arms. These differences were not statistically significant. IPSS (median [interquartile range]) declined from 17.0 (12.0-19.0) to 9.0 (5.0-13.0) with the plant drug and from 14.0 (11.0-18.0) to 8.0 (6.0-13.0) with tamsulosin after 12 weeks of treatment. The decline was individually significant in both groups (both, P < 0.001), but intergroup values showed no statistically significant difference at any point of time. IPSS <8 at study end was achieved by 10 and 7 patients, respectively, in the 2 arms (P = 0.548). The plant drug reduced prostate volume from 33.5 (26.2-45.9) mL to 31.6 (26.1-37.5) mL (P = 0.040). The corresponding reduction with tamsulosin, from 41.3 (29.4-51.3) mL to 39.9 (32.6-52.3) mL, was not statistically significant. Peak urinary flow rate did not change appreciably. Mild joint pain was the most common adverse event in both arms. No serious events were encountered. Compliance was satisfactory. These findings suggest that the M koenigii- and T terrestris-based formulation significantly lowered IPSS scores in the initial treatment of symptomatic BPH. Further trials are needed to determine if the beneficial effect is sustained beyond the 12-week observation period of this trial. Copyright © 2011 Elsevier HS Journals, Inc. All rights reserved.

Hypercaloric enteral nutrition in Amyotrophic Lateral Sclerosis: a randomized double-blind placebo-controlled trial

PubMed Central

Wills, Anne-Marie; Hubbard, Jane; Macklin, Eric A.; Glass, Jonathan; Tandan, Rup; Simpson, Ericka P; Brooks, Benjamin; Gelinas, Deborah; Mitsumoto, Hiroshi; Mozaffar, Tahseen; Hanes, Gregory P.; Ladha, Shafeeq S.; Heiman-Patterson, Terry; Katz, Jonathan; Lou, Jau-Shin; Mahoney, Katy; Grasso, Daniela; Lawson, Robert; Yu, Hong; Cudkowicz, Merit

2014-01-01

Background Amyotrophic Lateral Sclerosis (ALS) is a rapidly fatal neurodegenerative disease with few therapeutic options. Mild obesity is associated with greater survival in ALS patients and calorie-dense diets increase survival in an ALS mouse model. We therefore hypothesized that hypercaloric diets might lead to weight gain and slow ALS disease progression. Methods In this double-blind, placebo-controlled, multi-center clinical trial, we enrolled adults with ALS without a history of diabetes, significant liver or cardiovascular disease, who were already receiving percutaneous enteral nutrition. We randomly assigned participants to one of three dietary interventions: replacement calories using an isocaloric diet (controls) vs. a high-carbohydrate hypercaloric diet (HC/HC), vs. a high-fat hypercaloric diet (HF/HC). Participants received the intervention diets for four months and were followed for five months. The primary outcomes were safety and tolerability. Secondary outcomes included measures of disease progression, survival, and metabolism. This trial is registered with Clinicaltrials.gov, number NCT00983983. Findings A total of 24 participants were enrolled of whom 20 initiated study diet (six control, eight HC/HC, six HF/HC). Baseline demographics were similar among the three study arms. The HC/HC diet was better tolerated with fewer serious adverse events than the control diet (zero vs. nine, p<0·001) and fewer dose discontinuations due to adverse events (0% vs. 50%). There were no deaths in the HC/HC arm vs. three deaths (43%) in the control arm (logrank p = 0·03). The HF/HC arm was not statistically different from the controls in adverse events, tolerability, deaths or disease progression. Interpretation Our results suggest that hypercaloric enteral nutrition is safe and tolerable in ALS and support the study of nutritional interventions at earlier stages of the disease. Funding The Muscular Dystrophy Association with additional support from the National Center for Research Resources, the National Institutes of Health, and the Harvard NeuroDiscovery Center. PMID:24582471

Dopamine serotonin stabilizer RP5063: A randomized, double-blind, placebo-controlled multicenter trial of safety and efficacy in exacerbation of schizophrenia or schizoaffective disorder.

PubMed

Cantillon, Marc; Prakash, Arul; Alexander, Ajay; Ings, Robert; Sweitzer, Dennis; Bhat, Laxminarayan

2017-11-01

The study objectives were to evaluate the efficacy, safety, tolerability, and pharmacokinetics of RP5063 versus placebo. The study was conducted in adults with acute exacerbation of schizophrenia or schizoaffective disorder. This 28-day, multicenter, placebo-controlled, double-blind study randomized 234 subjects to RP5063 15, 30, or 50mg; aripiprazole; or placebo (3:3:3:1:2) once daily. The aripiprazole arm was included solely to show assay sensitivity and was not powered to show efficacy. The primary endpoint was change from baseline to Day 28/EOT (End-of-Treatment) in Positive and Negative Syndrome Scale (PANSS) total score; secondary endpoints included PANSS subscales, improvement ≥1 point on the Clinical Global Impressions-Severity (CGI-S), depression and cognition scales. The primary analysis of PANSS Total showed improvement by a mean (SE) of -20.23 (2.65), -15.42 (2.04), and -19.21 (2.39) in the RP5063 15, 30, and 50mg arms, versus -11.41 (3.45) in the placebo arm. The difference between treatment and placebo reached statistical significance for the 15mg (p=0.021) and 50mg (p=0.016) arms. Improvement with RP5063 was also seen for multiple secondary efficacy outcomes. Discontinuation for any reason was much lower for RP5063 (14%, 25%, 12%) versus placebo (26%) and aripiprazole (35%). The most common treatment-emergent adverse events (TEAE) in the RP5063 groups were insomnia and agitation. There were no significant changes in body weight, electrocardiogram, or incidence of orthostatic hypotension; there was a decrease in blood glucose, lipid profiles, and prolactin levels. In conclusion, the novel dopamine serotonin stabilizer, RP5063 is an efficacious and well-tolerated treatment for acute exacerbation of schizophrenia or schizoaffective disorder. Copyright © 2017. Published by Elsevier B.V.

Physiotherapy Rehabilitation for Osteoporotic Vertebral Fracture (PROVE): study protocol for a randomised controlled trial

PubMed Central

2014-01-01

Background Osteoporosis and vertebral fracture can have a considerable impact on an individual’s quality of life. There is increasing evidence that physiotherapy including manual techniques and exercise interventions may have an important treatment role. This pragmatic randomised controlled trial will investigate the clinical and cost-effectiveness of two different physiotherapy approaches for people with osteoporosis and vertebral fracture, in comparison to usual care. Methods/Design Six hundred people with osteoporosis and a clinically diagnosed vertebral fracture will be recruited and randomly allocated to one of three management strategies, usual care (control - A), an exercise-based physiotherapy intervention (B) or a manual therapy-based physiotherapy intervention (C). Those in the usual care arm will receive a single session of education and advice, those in the active treatment arms (B + C) will be offered seven individual physiotherapy sessions over 12 weeks. The trial is designed as a prospective, adaptive single-blinded randomised controlled trial. An interim analysis will be completed and if one intervention is clearly superior the trial will be adapted at this point to continue with just one intervention and the control. The primary outcomes are quality of life measured by the disease specific QUALLEFO 41 and the Timed Loaded Standing test measured at 1 year. Discussion There are a variety of different physiotherapy packages used to treat patients with osteoporotic vertebral fracture. At present, the indication for each different therapy is not well defined, and the effectiveness of different modalities is unknown. Trial registration Reference number ISRCTN49117867. PMID:24422876

Effect of study design on the reported effect of cardiac resynchronization therapy (CRT) on quantitative physiological measures: stratified meta-analysis in narrow-QRS heart failure and implications for planning future studies.

PubMed

Jabbour, Richard J; Shun-Shin, Matthew J; Finegold, Judith A; Afzal Sohaib, S M; Cook, Christopher; Nijjer, Sukhjinder S; Whinnett, Zachary I; Manisty, Charlotte H; Brugada, Josep; Francis, Darrel P

2015-01-06

Biventricular pacing (CRT) shows clear benefits in heart failure with wide QRS, but results in narrow QRS have appeared conflicting. We tested the hypothesis that study design might have influenced findings. We identified all reports of CRT-P/D therapy in subjects with narrow QRS reporting effects on continuous physiological variables. Twelve studies (2074 patients) met these criteria. Studies were stratified by presence of bias-resistance steps: the presence of a randomized control arm over a single arm, and blinded outcome measurement. Change in each endpoint was quantified using a standardized effect size (Cohen's d). We conducted separate meta-analyses for each variable in turn, stratified by trial quality. In non-randomized, non-blinded studies, the majority of variables (10 of 12, 83%) showed significant improvement, ranging from a standardized mean effect size of +1.57 (95%CI +0.43 to +2.7) for ejection fraction to +2.87 (+1.78 to +3.95) for NYHA class. In the randomized, non-blinded study, only 3 out of 6 variables (50%) showed improvement. For the randomized blinded studies, 0 out of 9 variables (0%) showed benefit, ranging from -0.04 (-0.31 to +0.22) for ejection fraction to -0.1 (-0.73 to +0.53) for 6-minute walk test. Differences in degrees of resistance to bias, rather than choice of endpoint, explain the variation between studies of CRT in narrow-QRS heart failure addressing physiological variables. When bias-resistance features are implemented, it becomes clear that these patients do not improve in any tested physiological variable. Guidance from studies without careful planning to resist bias may be far less useful than commonly perceived. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Contact Instrument Calibration Targets on Mars Rover Curiosity

NASA Image and Video Library

2012-02-07

Two instruments at the end of the robotic arm on NASA Mars rover Curiosity will use calibration targets attached to a shoulder joint of the arm. The penny is a size reference giving the public a familiar object for perceiving size on Mars easily.

JPRS Report, Arms Control. Reference Aid: Glossary of Arms Control Terms

DTIC Science & Technology

1989-03-20

BOMBA , ATOMHAfl ATOMIC BOMB [see BOMBA , HJEPHAfl] BOMBA , BOJOPOJHAH HYDROGEN BOMB BOMBA , HEHTPOHHAH NEUTRON BOMB BOMBA , HJEPHAfl NUCLEAR BOMB... BOMBA , HjJEPHAfl, «HMCTAfl» CLEAN NUCLEAR BOMB BOMBA , HJEPHAfl, ABMAlJMOHHAfl AIRCRAFT-DELIVERED NUCLEAR BOMB BOMBAP4MPOBKA, ATOMHAH ATOMIC BOMBING

Single-dose lubiprostone along with split-dose PEG solution without dietary restrictions for bowel cleansing prior to colonoscopy: a randomized, double-blind, placebo-controlled trial.

PubMed

Stengel, Joel Z; Jones, David P

2008-09-01

Proper colonic cleansing prior to colonoscopy is paramount to ensuring complete mucosal visualization and polyp identification. In a double-blind fashion, we compared single-dose lubiprostone (24 microg) versus placebo pretreatment prior to a split-dose polyethylene glycol electrolyte (PEG-E) bowel preparation without dietary restriction to determine the efficacy, safety, and patient tolerability. Two hundred patients referred for outpatient colorectal cancer screening were randomized to receive a single-dose of unlabeled lubiprostone (24 microg) or placebo prior to a split-dose PEG-E bowel preparation without dietary restriction. The patients were surveyed prior to the colonoscopy on the tolerability of the bowel preparation, and any adverse events were recorded. The cleanliness of the colon was graded by the endoscopist during the procedure utilizing the Ottawa bowel preparation scale. One hundred ninety-one patients completed the study (95%). Split-dose PEG-E with lubiprostone pretreatment was found to be more effective at bowel cleansing in each segment of the colon when compared with split-dose PEG-E with placebo (P < 0.001). Patients enrolled in the lubiprostone treatment arm rated the overall experience as more tolerable (P 0.003) and complained of less abdominal bloating (P 0.049). No differences were observed between the groups for treatment-emergent side effects or adverse events (P > 0.05). Single-dose lubiprostone prior to split-dose PEG-E without dietary restriction significantly improves colonic mucosa visualization during colonoscopy and is well tolerated by patients.

Current challenges for clinical trials of cardiovascular medical devices.

PubMed

Zannad, Faiez; Stough, Wendy Gattis; Piña, Ileana L; Mehran, Roxana; Abraham, William T; Anker, Stefan D; De Ferrari, Gaetano M; Farb, Andrew; Geller, Nancy L; Kieval, Robert S; Linde, Cecilia; Redberg, Rita F; Stein, Kenneth; Vincent, Alphons; Woehrle, Holger; Pocock, Stuart J

2014-07-15

Several features of cardiovascular devices raise considerations for clinical trial conduct. Prospective, randomized, controlled trials remain the highest quality evidence for safety and effectiveness assessments, but, for instance, blinding may be challenging. In order to avoid bias and not confound data interpretation, the use of objective endpoints and blinding patients, study staff, core labs, and clinical endpoint committees to treatment assignment are helpful approaches. Anticipation of potential bias should be considered and planned for prospectively in a cardiovascular device trial. Prospective, single-arm studies (often referred to as registry studies) can provide additional data in some cases. They are subject to selection bias even when carefully designed; thus, they are generally not acceptable as the sole basis for pre-market approval of high risk cardiovascular devices. However, they complement the evidence base and fill the gaps unanswered by randomized trials. Registry studies present device safety and effectiveness in day-to-day clinical practice settings and detect rare adverse events in the post-market period. No single research design will be appropriate for every cardiovascular device or target patient population. The type of trial, appropriate control group, and optimal length of follow-up will depend on the specific device, its potential clinical benefits, the target patient population and the existence (or lack) of effective therapies, and its anticipated risks. Continued efforts on the part of investigators, the device industry, and government regulators are needed to reach the optimal approach for evaluating the safety and performance of innovative devices for the treatment of cardiovascular disease. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Upper arm anthropometrics versus DXA scan in survivors of acute respiratory distress syndrome.

PubMed

Chan, Kitty S; Mourtzakis, Marina; Aronson Friedman, Lisa; Dinglas, Victor D; Hough, Catherine L; Ely, E Wesley; Morris, Peter E; Hopkins, Ramona O; Needham, Dale M

2018-04-01

Survivors of acute respiratory distress syndrome (ARDS) experience severe muscle wasting. Upper arm anthropometrics can provide a quick, non-invasive estimate of muscle status, but its accuracy is unknown. This study examines the accuracy of upper arm percent muscle area (UAMA) with reference measures of lean mass from dual energy X-ray absorptiometry (DXA). Data are from 120 ARDS survivors participating in a multicenter national study. Receiver operating characteristic (ROC) curves, by patient sex, demonstrated that UAMA did no better than chance in discriminating low appendicular skeletal muscle mass identified using DXA findings (c-statistics, 6 months: 0.50-0.59, 12 months: 0.54-0.57). Modest correlations of UAMA with DXA measures (whole-body: r = 0.46-0.49, arm-specific: r = 0.50-0.51, p < 0.001) and Bland-Altman plots indicate poor precision. UAMA is not an appropriate screening measure for estimating muscle mass when compared to a DXA reference standard. Alternate screening measures should be evaluated in ARDS survivors.

Robust training attenuates TBI-induced deficits in reference and working memory on the radial 8-arm maze

PubMed Central

Sebastian, Veronica; Diallo, Aissatou; Ling, Douglas S. F.; Serrano, Peter A.

2013-01-01

Globally, it is estimated that nearly 10 million people sustain severe brain injuries leading to hospitalization and/or death every year. Amongst survivors, traumatic brain injury (TBI) results in a wide variety of physical, emotional and cognitive deficits. The most common cognitive deficit associated with TBI is memory loss, involving impairments in spatial reference and working memory. However, the majority of research thus far has characterized the deficits associated with TBI on either reference or working memory systems separately, without investigating how they interact within a single task. Thus, we examined the effects of TBI on short-term working and long-term reference memory using the radial 8-arm maze (RAM) with a sequence of four baited and four unbaited arms. Subjects were given 10 daily trials for 6 days followed by a memory retrieval test 2 weeks after training. Multiple training trials not only provide robust training, but also test the subjects' ability to frequently update short-term memory while learning the reference rules of the task. Our results show that TBI significantly impaired short-term working memory function on previously acquired spatial information but has little effect on long-term reference memory. Additionally, TBI significantly increased working memory errors during acquisition and reference memory errors during retention testing 2 weeks later. With a longer recovery period after TBI, the robust RAM training mitigated the reference memory deficit in retention but not the short-term working memory deficit during acquisition. These results identify the resiliency and vulnerabilities of short-term working and long-term reference memory to TBI in the context of robust training. The data highlight the role of cognitive training and other behavioral remediation strategies implicated in attenuating deficits associated with TBI. PMID:23653600

A generic minimization random allocation and blinding system on web.

PubMed

Cai, Hongwei; Xia, Jielai; Xu, Dezhong; Gao, Donghuai; Yan, Yongping

2006-12-01

Minimization is a dynamic randomization method for clinical trials. Although recommended by many researchers, the utilization of minimization has been seldom reported in randomized trials mainly because of the controversy surrounding the validity of conventional analyses and its complexity in implementation. However, both the statistical and clinical validity of minimization were demonstrated in recent studies. Minimization random allocation system integrated with blinding function that could facilitate the implementation of this method in general clinical trials has not been reported. SYSTEM OVERVIEW: The system is a web-based random allocation system using Pocock and Simon minimization method. It also supports multiple treatment arms within a trial, multiple simultaneous trials, and blinding without further programming. This system was constructed with generic database schema design method, Pocock and Simon minimization method and blinding method. It was coded with Microsoft Visual Basic and Active Server Pages (ASP) programming languages. And all dataset were managed with a Microsoft SQL Server database. Some critical programming codes were also provided. SIMULATIONS AND RESULTS: Two clinical trials were simulated simultaneously to test the system's applicability. Not only balanced groups but also blinded allocation results were achieved in both trials. Practical considerations for minimization method, the benefits, general applicability and drawbacks of the technique implemented in this system are discussed. Promising features of the proposed system are also summarized.

Altering Effort Costs in Parkinson's Disease with Noninvasive Cortical Stimulation

PubMed Central

Salimpour, Yousef; Mari, Zoltan K.

2015-01-01

In Parkinson's disease (PD), the human brain is capable of producing motor commands, but appears to require greater than normal subjective effort, particularly for the more-affected side. What is the nature of this subjective effort and can it be altered? We used an isometric task in which patients produced a goal force by engaging both arms, but were free to assign any fraction of that force to each arm. The patients preferred their less-affected arm, but only in some directions. This preference was correlated with lateralization of signal-dependent noise: the direction of force for which the brain was less willing to assign effort to an arm was generally the direction for which that arm exhibited greater noise. Therefore, the direction-dependent noise in each arm acted as an implicit cost that discouraged use of that arm. To check for a causal relationship between noise and motor cost, we used bilateral transcranial direct current stimulation of the motor cortex, placing the cathode on the more-affected side and the anode on the less-affected side. This stimulation not only reduced the noise on the more-affected arm, it also increased the willingness of the patients to assign force to that arm. In a 3 d double-blind study and in a 10 d repeated stimulation study, bilateral stimulation of the two motor cortices with cathode on the more-affected side reduced noise and increased the willingness of the patients to exert effort. This stimulation also improved the clinical motor symptoms of the disease. SIGNIFICANCE STATEMENT In Parkinson's disease, patients are less willing to assign force to their affected arm. Here, we find that this pattern is direction dependent: directions for which the arm is noisier coincide with directions for which the brain is less willing to assign force. We hypothesized that if we could reduce the noise on the affected arm, then we may increase the willingness for the brain to assign force to that arm. We found a way to do this via noninvasive cortical stimulation. In addition to reducing effort costs associated with the affected arm, the cortical stimulation also improved clinical motor symptoms of the disease. PMID:26338339

An Estimate of the Number of Persons with Visual and Physical Handicaps Eligible for DBPH Services.

ERIC Educational Resources Information Center

Pollet, Dorothy, Comp.

It is estimated that 1,868,000 people are certainly eligible for the services of the Library of Congress Division for the Blind and Physically Handicapped. Between 5,781,500 and 11,384,500 are also possibly eligible. Handicapping conditions which are certainly eligible are severe visual impairment, absence of one or both arms or hands, cerebral…

A Compendium of the Physiological Demands of the 32 Critical Physically Demanding Tasks of Combat Arms Soldiers

DTIC Science & Technology

As part of the U.S. Army Physical Demands Study (which led to the development of the Occupational Physical Assessment Test (OPAT)), 32 physically ...demanding tasks were identified as being critical to combat arms soldiers. In order to identify the most physically demanding of those tests, data were...comprehensive reference of the physiological demands of the critical physically demanding tasks of combat arms Soldiers.

Accreditation for Armed Forces Educational Institutions.

ERIC Educational Resources Information Center

Tarquine, Robert Blaine

The report established the need for educational accreditation and consolidates the various means of achieving accreditation that are available to the Armed Forces, into one accessible reference. The scope of each accrediting method is presented in detail, allowing educational officials to evaluate the methods in respect to their individual…

False predictions about the detectability of visual changes: the role of beliefs about attention, memory, and the continuity of attended objects in causing change blindness blindness.

PubMed

Levin, Daniel T; Drivdahl, Sarah B; Momen, Nausheen; Beck, Melissa R

2002-12-01

Recently, a number of experiments have emphasized the degree to which subjects fail to detect large changes in visual scenes. This finding, referred to as "change blindness," is often considered surprising because many people have the intuition that such changes should be easy to detect. documented this intuition by showing that the majority of subjects believe they would notice changes that are actually very rarely detected. Thus subjects exhibit a metacognitive error we refer to as "change blindness blindness." Here, we test whether CBB is caused by a misestimation of the perceptual experience associated with visual changes and show that it persists even when the pre- and postchange views are separated by long delays. In addition, subjects overestimate their change detection ability both when the relevant changes are illustrated by still pictures, and when they are illustrated using videos showing the changes occurring in real time. We conclude that CBB is a robust phenomenon that cannot be accounted for by failure to understand the specific perceptual experience associated with a change. Copyright 2002 Elsevier Science (USA)

PHYSICAL EDUCATION FOR BLIND CHILDREN.

ERIC Educational Resources Information Center

BUELL, CHARLES E.

A PRACTICAL RATHER THAN A THEORETICAL REFERENCE GUIDE, THE BOOK DISCUSSES THE NEED OF THE BLIND OR VISUALLY IMPAIRED CHILD FOR PHYSICAL EDUCATION. PAST AND PRESENT PROGRAMS IN PUBLIC AND RESIDENTIAL SCHOOLS, RECREATION AND LEISURE TIME ACTIVITIES (A GUIDE FOR PARENTS), SPORTS AND INTERSCHOLASTIC COMPETITION, ACTIVE GAMES, CONTESTS, RELAYS, AND…

Further analysis of PREVAIL: enzalutamide use in chemotherapy-naïve men with metastatic castration-resistant prostate cancer

PubMed Central

Aragon-Ching, Jeanny B

2014-01-01

PREVAIL was a phase III multinational, double-blind, placebo-controlled trial that enrolled chemotherapy-naïve men with metastatic castration-resistant prostate cancer (mCRPC), which showed remarkable improvement in co-primary endpoints with an overall 81% reduction in the risk of radiographic progression, as well as 29% reduction in the risk of death in favor of the enzalutamide arm over placebo. All secondary endpoints including time to subsequent chemotherapy initiation and prostate specific antigen (PSA) progression were in favor of the enzalutamide arm. The results of PREVAIL shows the utility of enzalutamide that would likely soon expand the indication to asymptomatic or minimally symptomatic men with mCRPC not previously treated with chemotherapy. PMID:25080931

Further analysis of PREVAIL: enzalutamide use in chemotherapy-naïve men with metastatic castration-resistant prostate cancer.

PubMed

Aragon-Ching, Jeanny B

2014-01-01

PREVAIL was a phase III multinational, double-blind, placebo-controlled trial that enrolled chemotherapy-naïve men with metastatic castration-resistant prostate cancer (mCRPC), which showed remarkable improvement in co-primary endpoints with an overall 81% reduction in the risk of radiographic progression, as well as 29% reduction in the risk of death in favor of the enzalutamide arm over placebo. All secondary endpoints including time to subsequent chemotherapy initiation and prostate specific antigen (PSA) progression were in favor of the enzalutamide arm. The results of PREVAIL shows the utility of enzalutamide that would likely soon expand the indication to asymptomatic or minimally symptomatic men with mCRPC not previously treated with chemotherapy.

Trial of early aggressive therapy in polyarticular juvenile idiopathic arthritis.

PubMed

Wallace, Carol A; Giannini, Edward H; Spalding, Steven J; Hashkes, Philip J; O'Neil, Kathleen M; Zeft, Andrew S; Szer, Ilona S; Ringold, Sarah; Brunner, Hermine I; Schanberg, Laura E; Sundel, Robert P; Milojevic, Diana; Punaro, Marilynn G; Chira, Peter; Gottlieb, Beth S; Higgins, Gloria C; Ilowite, Norman T; Kimura, Yukiko; Hamilton, Stephanie; Johnson, Anne; Huang, Bin; Lovell, Daniel J

2012-06-01

To determine whether aggressive treatment initiated early in the course of rheumatoid factor (RF)-positive or RF-negative polyarticular juvenile idiopathic arthritis (JIA) can induce clinical inactive disease within 6 months. Between May 2007 and October 2010, a multicenter, prospective, randomized, double-blind, placebo-controlled trial of 2 aggressive treatments was conducted in 85 children ages 2-16 years with polyarticular JIA of <12 months' duration. Patients received either methotrexate (MTX) 0.5 mg/kg/week (maximum 40 mg) subcutaneously, etanercept 0.8 mg/kg/week (maximum 50 mg), and prednisolone 0.5 mg/kg/day (maximum 60 mg) tapered to 0 by 17 weeks (arm 1), or MTX (same dosage as arm 1), etanercept placebo, and prednisolone placebo (arm 2). The primary outcome measure was clinical inactive disease at 6 months. An exploratory phase determined the rate of clinical remission on medication (6 months of continuous clinical inactive disease) at 12 months. By 6 months, clinical inactive disease had been achieved in 17 (40%) of 42 patients in arm 1 and 10 (23%) of 43 patients in arm 2 (χ(2) = 2.91, P = 0.088). After 12 months, clinical remission on medication was achieved in 9 patients in arm 1 and 3 patients in arm 2 (P = 0.053). There were no significant interarm differences in adverse events. Although this study did not meet its primary end point, early aggressive therapy in this cohort of children with recent-onset polyarticular JIA resulted in clinical inactive disease by 6 months and clinical remission on medication within 12 months of treatment in substantial proportions of patients in both arms. Copyright © 2012 by the American College of Rheumatology.

Effect of the patient education - Learning and Coping strategies - in cardiac rehabilitation on return to work at one year: a randomised controlled trial show (LC-REHAB).

PubMed

Bitsch, Birgitte Laier; Nielsen, Claus Vinther; Stapelfeldt, Christina Malmose; Lynggaard, Vibeke

2018-05-21

Personal resources are identified as important for the ability to return to work (RTW) for patients with ischaemic heart disease (IHD) or heart failure (HF) undergoing cardiac rehabilitation (CR). The patient education 'Learning and Coping' (LC) addresses personal resources through a pedagogical approach. This trial aimed to assess effect of adding LC strategies in CR compared to standard CR measured on RTW status at one-year follow-up after CR. In an open parallel randomised controlled trial, patients with IHD or HF were block-randomised in a 1:1 ratio to the LC arm (LC plus CR) or the control arm (CR alone) across three Danish hospital units. Eligible patients were aged 18 to ≤60 and had not left the labour market. The intervention was developed from an inductive pedagogical approach consisting of individual interviews and group based teaching by health professionals with experienced patients as co-educators. The control arm consisted of deductive teaching (standard CR). RTW status was derived from the Danish Register for Evaluation of Marginalisation (DREAM). Blinding was not possible. The effect was evaluated by logistic regression analysis and reported as crude and adjusted odds ratios (OR) with 95% confidence interval (CI). The population for the present analysis was N = 244 (LC arm: n = 119 versus control arm: n = 125). No difference in RTW status was found at one year across arms (LC arm: 64.7% versus control arm: 68.8%, adjusted odds ratio OR: 0.76, 95% CI: 0.43-1.31). Addition of LC strategies in CR showed no improvement in RTW at one year follow-up. www.clinicaltrials.gov identifier NCT01668394. First Posted: August 20, 2012.

Beta-blocker therapy for tremor in Parkinson's disease.

PubMed

Crosby, N J; Deane, K H O; Clarke, C E

2003-01-01

The tremor of Parkinson's disease can cause considerable disability for the individual concerned. Traditional antiparkinsonian therapies such as levodopa have only a minor effect on tremor. Beta-blockers are used to attenuate other forms of tremor such as Essential Tremor or the tremor associated with anxiety. It is thought that beta-blockers may be of use in controlling the tremor of Parkinson's disease. To compare the efficacy and safety of adjuvant beta-blocker therapy against placebo for the treatment of tremor in patients with Parkinson's disease. Electronic searches of MEDLINE, EMBASE, SCISEARCH, BIOSIS, GEROLIT, OLDMEDLINE, LILACS, MedCarib, PASCAL, JICST-EPLUS, RUSSMED, DISSERTATION ABSTRACTS, SIGLE, ISI-ISTP, Aslib Index to Theses, The Cochrane Controlled Trials Register, Clinicaltrials.gov, metaRegister of Controlled Trials, NIDRR, NRR and CENTRAL were conducted. Grey literature was hand searched and the reference lists of identified studies and reviews examined. The manufacturers of beta-blockers were contacted. Randomised controlled trials of adjuvant beta-blocker therapy versus placebo in patients with a clinical diagnosis of idiopathic Parkinson's disease. Data was abstracted independently by two of the authors onto standardised forms and disagreements were resolved by discussion. Four randomised controlled trials were found comparing beta-blocker therapy with placebo in patients with idiopathic Parkinson's disease. These were double-blind cross-over studies involving a total of 72 patients. Three studies did not present data from the first arm, instead presenting results as combined data from both treatment arms and both placebo arms. The risk of a carry-over effect into the second arm meant that these results were not analysed. The fourth study presented data from each arm. This was in the form of a mean total score for tremor for each group. Details of the baseline scores, the numbers of patients in each group and standard deviations were not provided, meaning that the magnitude and significance of any changes due to therapy could not be calculated. One study reported a substantial fall in heart rate in 14 of the 22 patients, with one patient withdrawing after his heart rate dropped to 56 beats per minute (baseline heart rate was not reported). In view of this lack of evidence, it is impossible to determine whether beta-blocker therapy is effective and safe for the treatment of tremor in Parkinson's disease. The high frequency of bradycardia in one trial raises some concerns about the prescription of beta-blockers to normotensive elderly patients but the study was too small for the true degree of risk to be calculated.

Naproxen Sodium for Pain Control With Intrauterine Device Insertion: A Randomized Controlled Trial.

PubMed

Ngo, Lynn L; Braaten, Kari P; Eichen, Eva; Fortin, Jennifer; Maurer, Rie; Goldberg, Alisa B

2016-12-01

To evaluate whether 550 mg oral naproxen sodium given 1 hour before intrauterine device (IUD) insertion is effective for pain relief as compared with placebo. This was a randomized, double-blind, placebo-controlled trial. The primary outcome was pain with IUD insertion measured on a 100-mm visual analog scale (VAS). Our sample size was calculated to detect a 15-mm difference in VAS scores with 80% power (α=0.05). Secondary outcomes included pain with tenaculum placement, uterine sounding, and 5 and 15 minutes postinsertion. A total of 118 women were enrolled and analyzed (58 in the naproxen sodium arm, 60 in the placebo arm, 97% nulliparous) between May 11, 2015, and March 25, 2016. There were no differences in baseline demographics or reproductive characteristics between arms. There were no differences in median VAS pain scores for the primary outcome of pain with IUD insertion between the naproxen sodium arm compared with the placebo arm (69 compared with 66 mm, P=.89). There were no differences in the secondary outcomes of median VAS pain scores with tenaculum placement (37 compared with 32 mm, P=.97) or uterine sounding (60 compared with 58 mm, P=.66). However, median pain scores postprocedure were lower in the naproxen arm as compared with the placebo arm: 17 compared with 26 mm (P=.01) at 5 minutes and 13 compared with 24 mm (P=.01) at 15 minutes postinsertion. Oral naproxen sodium does not reduce pain with IUD insertion but does reduce pain after insertion and should be considered as a premedication. ClinicalTrials.gov, http://clinicaltrials.gov, NCT02388191.

49 CFR 572.17 - Neck.

Code of Federal Regulations, 2012 CFR

2012-10-01

... (c) of this section, the head shall rotate in reference to the pendulum's longitudinal centerline a... distance between (1) the position relative to the pendulum arm of the head center of gravity at time zero, and (2) the position relative to the pendulum arm of the head center of gravity at time T as...

49 CFR 572.7 - Neck.

Code of Federal Regulations, 2014 CFR

2014-10-01

... paragraph (c) of this section, the head shall rotate in reference to the pendulum's longitudinal centerline... the straight line distance between (1) the position relative to the pendulum arm of the head center of gravity at time zero, and (2) the position relative to the pendulum arm of the head center of gravity at...

49 CFR 572.17 - Neck.

Code of Federal Regulations, 2014 CFR

2014-10-01

... (c) of this section, the head shall rotate in reference to the pendulum's longitudinal centerline a... distance between (1) the position relative to the pendulum arm of the head center of gravity at time zero, and (2) the position relative to the pendulum arm of the head center of gravity at time T as...

49 CFR 572.17 - Neck.

Code of Federal Regulations, 2013 CFR

2013-10-01

... (c) of this section, the head shall rotate in reference to the pendulum's longitudinal centerline a... distance between (1) the position relative to the pendulum arm of the head center of gravity at time zero, and (2) the position relative to the pendulum arm of the head center of gravity at time T as...

49 CFR 572.17 - Neck.

Code of Federal Regulations, 2010 CFR

2010-10-01

... (c) of this section, the head shall rotate in reference to the pendulum's longitudinal centerline a... distance between (1) the position relative to the pendulum arm of the head center of gravity at time zero, and (2) the position relative to the pendulum arm of the head center of gravity at time T as...

49 CFR 572.17 - Neck.

Code of Federal Regulations, 2011 CFR

2011-10-01

... (c) of this section, the head shall rotate in reference to the pendulum's longitudinal centerline a... distance between (1) the position relative to the pendulum arm of the head center of gravity at time zero, and (2) the position relative to the pendulum arm of the head center of gravity at time T as...

49 CFR 572.7 - Neck.

Code of Federal Regulations, 2012 CFR

2012-10-01

... paragraph (c) of this section, the head shall rotate in reference to the pendulum's longitudinal centerline... the straight line distance between (1) the position relative to the pendulum arm of the head center of gravity at time zero, and (2) the position relative to the pendulum arm of the head center of gravity at...

49 CFR 572.7 - Neck.

Code of Federal Regulations, 2013 CFR

2013-10-01

... paragraph (c) of this section, the head shall rotate in reference to the pendulum's longitudinal centerline... the straight line distance between (1) the position relative to the pendulum arm of the head center of gravity at time zero, and (2) the position relative to the pendulum arm of the head center of gravity at...

49 CFR 572.7 - Neck.

Code of Federal Regulations, 2010 CFR

2010-10-01

... paragraph (c) of this section, the head shall rotate in reference to the pendulum's longitudinal centerline... the straight line distance between (1) the position relative to the pendulum arm of the head center of gravity at time zero, and (2) the position relative to the pendulum arm of the head center of gravity at...

49 CFR 572.7 - Neck.

Code of Federal Regulations, 2011 CFR

2011-10-01

... paragraph (c) of this section, the head shall rotate in reference to the pendulum's longitudinal centerline... the straight line distance between (1) the position relative to the pendulum arm of the head center of gravity at time zero, and (2) the position relative to the pendulum arm of the head center of gravity at...

22 CFR 126.1 - Prohibited exports and sales to certain countries.

Code of Federal Regulations, 2010 CFR

2010-04-01

...-case basis, for supplies of arms and related materials or technical training and assistance intended... Haiti, supplies of arms and related materials for technical training and assistance intended solely for..., defense services or technical data subject to this subchapter may be made to any country referred to in...

Reference Values for Body Composition and Anthropometric Measurements in Athletes

PubMed Central

Santos, Diana A.; Dawson, John A.; Matias, Catarina N.; Rocha, Paulo M.; Minderico, Cláudia S.; Allison, David B.; Sardinha, Luís B.; Silva, Analiza M.

2014-01-01

Background Despite the importance of body composition in athletes, reference sex- and sport-specific body composition data are lacking. We aim to develop reference values for body composition and anthropometric measurements in athletes. Methods Body weight and height were measured in 898 athletes (264 female, 634 male), anthropometric variables were assessed in 798 athletes (240 female and 558 male), and in 481 athletes (142 female and 339 male) with dual-energy X-ray absorptiometry (DXA). A total of 21 different sports were represented. Reference percentiles (5th, 25th, 50th, 75th, and 95th) were calculated for each measured value, stratified by sex and sport. Because sample sizes within a sport were often very low for some outcomes, the percentiles were estimated using a parametric, empirical Bayesian framework that allowed sharing information across sports. Results We derived sex- and sport-specific reference percentiles for the following DXA outcomes: total (whole body scan) and regional (subtotal, trunk, and appendicular) bone mineral content, bone mineral density, absolute and percentage fat mass, fat-free mass, and lean soft tissue. Additionally, we derived reference percentiles for height-normalized indexes by dividing fat mass, fat-free mass, and appendicular lean soft tissue by height squared. We also derived sex- and sport-specific reference percentiles for the following anthropometry outcomes: weight, height, body mass index, sum of skinfold thicknesses (7 skinfolds, appendicular skinfolds, trunk skinfolds, arm skinfolds, and leg skinfolds), circumferences (hip, arm, midthigh, calf, and abdominal circumferences), and muscle circumferences (arm, thigh, and calf muscle circumferences). Conclusions These reference percentiles will be a helpful tool for sports professionals, in both clinical and field settings, for body composition assessment in athletes. PMID:24830292

Reduction of measurement errors in OCT scanning

NASA Astrophysics Data System (ADS)

Morel, E. N.; Tabla, P. M.; Sallese, M.; Torga, J. R.

2018-03-01

Optical coherence tomography (OCT) is a non-destructive optical technique, which uses a light source with a wide band width that focuses on a point in the sample to determine the distance (strictly, the optical path difference, OPD) between this point and a reference surface. The point can be superficial or at an interior interface of the sample (transparent or semitransparent), allowing topographies and / or tomographies in different materials. The Michelson interferometer is the traditional experimental scheme for this technique, in which a beam of light is divided into two arms, one the reference and the other the sample. The overlap of reflected light in the sample and in the reference generates an interference signal that gives us information about the OPD between arms. In this work, we work on the experimental configuration in which the reference signal and the reflected signal in the sample travel on the same arm, improving the quality of the interference signal. Among the most important aspects of this improvement we can mention that the noise and errors produced by the relative reference-sample movement and by the dispersion of the refractive index are considerably reduced. It is thus possible to obtain 3D images of surfaces with a spatial resolution in the order of microns. Results obtained on the topography of metallic surfaces, glass and inks printed on paper are presented.

22 CFR 120.28 - Listing of forms referred to in this subchapter.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 22 Foreign Relations 1 2013-04-01 2013-04-01 false Listing of forms referred to in this subchapter. 120.28 Section 120.28 Foreign Relations DEPARTMENT OF STATE INTERNATIONAL TRAFFIC IN ARMS REGULATIONS PURPOSE AND DEFINITIONS § 120.28 Listing of forms referred to in this subchapter. The forms referred to in...

22 CFR 120.28 - Listing of forms referred to in this subchapter.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 22 Foreign Relations 1 2014-04-01 2014-04-01 false Listing of forms referred to in this subchapter. 120.28 Section 120.28 Foreign Relations DEPARTMENT OF STATE INTERNATIONAL TRAFFIC IN ARMS REGULATIONS PURPOSE AND DEFINITIONS § 120.28 Listing of forms referred to in this subchapter. The forms referred to in...

22 CFR 120.28 - Listing of forms referred to in this subchapter.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Listing of forms referred to in this subchapter. 120.28 Section 120.28 Foreign Relations DEPARTMENT OF STATE INTERNATIONAL TRAFFIC IN ARMS REGULATIONS PURPOSE AND DEFINITIONS § 120.28 Listing of forms referred to in this subchapter. The forms referred to in...

22 CFR 120.28 - Listing of forms referred to in this subchapter.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 22 Foreign Relations 1 2011-04-01 2011-04-01 false Listing of forms referred to in this subchapter. 120.28 Section 120.28 Foreign Relations DEPARTMENT OF STATE INTERNATIONAL TRAFFIC IN ARMS REGULATIONS PURPOSE AND DEFINITIONS § 120.28 Listing of forms referred to in this subchapter. The forms referred to in...

Characteristics of women with nausea and vomiting of pregnancy who chose to continue compassionate use of placebo after a randomised trial.

PubMed

Matok, I; Umans, J; Feghali, M N; Clark, S; Caritis, S; Miodovnik, M; Hankins, G; Mattison, D R; Nordeng, H; Koren, G

2013-08-01

The placebo effect has not been characterised in pregnant women suffering from nausea and vomiting of pregnancy (NVP). Our aim was to characterise determinants of the placebo effect in women treated with placebo for NVP. We analysed data from a multicentre, double blind randomised controlled trial of Diclectin (delayed release doxylamine and pyridoxine) vs placebo for the treatment of NVP. A total of 127 women in the placebo arm and 130 in the active arm provided evaluable data for this analysis. Women who chose to continue placebo on a compassionate basis (n = 41) had significantly better improvement in symptoms of NVP and higher Wellbeing scores than those who did not ask to continue compassionate use. Results were similar in the active drug arm. The request to continue compassionate use of either placebo or active drug could be predicted by greater improvement in symptoms of NVP during the trial period.

Referred pain from myofascial trigger points in head, neck, shoulder, and arm muscles reproduces pain symptoms in blue-collar (manual) and white-collar (office) workers.

PubMed

Fernández-de-las-Peñas, César; Gröbli, Christian; Ortega-Santiago, Ricardo; Fischer, Christine Stebler; Boesch, Daniel; Froidevaux, Philippe; Stocker, Lilian; Weissmann, Richard; González-Iglesias, Javier

2012-07-01

To describe the prevalence and referred pain area of trigger points (TrPs) in blue-collar (manual) and white-collar (office) workers, and to analyze if the referred pain pattern elicited from TrPs completely reproduces the overall spontaneous pain pattern. Sixteen (62% women) blue-collar and 19 (75% women) white-collar workers were included in this study. TrPs in the temporalis, masseter, upper trapezius, sternocleidomastoid, splenius capitis, oblique capitis inferior, levator scapulae, scalene, pectoralis major, deltoid, infraspinatus, extensor carpi radialis brevis and longus, extensor digitorum communis, and supinator muscles were examined bilaterally (hyper-sensible tender spot within a palpable taut band, local twitch response with snapping palpation, and elicited referred pain pattern with palpation) by experienced assessors blinded to the participants' condition. TrPs were considered active when the local and referred pain reproduced any symptom and the patient recognized the pain as familiar. The referred pain areas were drawn on anatomic maps, digitized, and measured. Blue-collar workers had a mean of 6 (SD: 3) active and 10 (SD: 5) latent TrPs, whereas white-collar workers had a mean of 6 (SD: 4) active and 11 (SD: 6) latent TrPs (P>0.548). No significant differences in the distribution of active and latent TrPs in the analyzed muscles between groups were found. Active TrPs in the upper trapezius, infraspinatus, levator scapulae, and extensor carpi radialis brevis muscles were the most prevalent in both groups. Significant differences in referred pain areas between muscles (P<0.001) were found; pectoralis major, infraspinatus, upper trapezius, and scalene muscles showed the largest referred pain areas (P<0.01), whereas the temporalis, masseter, and splenius capitis muscles showed the smallest (P<0.05). The combination of the referred pain from TrPs reproduced the overall clinical pain area in all participants. Blue-collar and white-collar workers exhibited a similar number of TrPs in the upper quadrant musculature. The referred pain elicited by active TrPs reproduced the overall pain pattern. The distribution of TrPs was not significantly different between groups. Clinicians should examine for the presence of muscle TrPs in blue-collar and white-collar workers.

Intensity of leg and arm training after primary middle-cerebral-artery stroke: a randomised trial.

PubMed

Kwakkel, G; Wagenaar, R C; Twisk, J W; Lankhorst, G J; Koetsier, J C

1999-07-17

We investigated the effects of different intensities of arm and leg rehabilitation training on the functional recovery of activities of daily living (ADL), walking ability, and dexterity of the paretic arm, in a single-blind randomised controlled trial. Within 14 days after stroke onset, 101 severely disabled patients with a primary middle-cerebral-artery stroke were randomly assigned to: a rehabilitation programme with emphasis on arm training; a rehabilitation programme with emphasis on leg training; or a control programme in which the arm and leg were immobilised with an inflatable pressure splint. Each treatment regimen was applied for 30 min, 5 days a week during the first 20 weeks after stroke. In addition, all patients underwent a basic rehabilitation programme. The main outcome measures were ability in ADL (Barthel index), walking ability (functional ambulation categories), and dexterity of the paretic arm (Action Research arm test) at 6, 12, 20, and 26 weeks. Analyses were by intention to treat. At week 20, the leg-training group (n=31) had higher scores than the control group (n=37) for ADL ability (median 19 [IQR 16-20] vs 16 [10-19], p<0.05), walking ability (4 [3-5] vs 3 [1-4], p<0.05), and dexterity (2 [0-56] vs 0 [0-2], p<0.01). The arm-training group (n=33) differed significantly from the control group only in dexterity (9 [0-39] vs 0 [0-2], p<0.01). There were no significant differences in these endpoints at 20 weeks between the arm-training and leg-training groups. Greater intensity of leg rehabilitation improves functional recovery and health-related functional status, whereas greater intensity of arm rehabilitation results in small improvements in dexterity, providing further evidence that exercise therapy primarily induces treatment effects on the abilities at which training is specifically aimed.

CD-ROM: A New Light for the Blind and Visually Impaired.

ERIC Educational Resources Information Center

Mates, Barbara T.

1990-01-01

Describes ways of using CD-ROM technology for the benefit of blind and visually impaired library patrons. Science, reference, and American historical documents that can be converted to braille, large print, or voice output from CD-ROMs are described, and hardware, software, and staff considerations are discussed. (LRW)

Information Technology and Disabilities, 1994.

ERIC Educational Resources Information Center

McNulty, Tom, Ed.

1994-01-01

Four issues of this newsletter on information technology and disabilities (ITD) contain the following articles: "Building an Accessible CD-ROM Reference Station" (Rochelle Wyatt and Charles Hamilton); "Development of an Accessible User Interface for People Who Are Blind or Vision Impaired as Part of the Re-Computerisation of Royal Blind Society…

20 CFR 416.938 - What we mean by approved institutions or facilities.

Code of Federal Regulations, 2013 CFR

2013-04-01

... INCOME FOR THE AGED, BLIND, AND DISABLED Determining Disability and Blindness Drug Addiction and... drug addiction or alcoholism in conformity with applicable Federal or State laws and regulations; (b... refer persons for treatment of drug addiction or alcoholism; (c) State licensed or certified care...

20 CFR 416.938 - What we mean by approved institutions or facilities.

Code of Federal Regulations, 2011 CFR

2011-04-01

... INCOME FOR THE AGED, BLIND, AND DISABLED Determining Disability and Blindness Drug Addiction and... drug addiction or alcoholism in conformity with applicable Federal or State laws and regulations; (b... refer persons for treatment of drug addiction or alcoholism; (c) State licensed or certified care...

20 CFR 416.938 - What we mean by approved institutions or facilities.

Code of Federal Regulations, 2012 CFR

2012-04-01

... INCOME FOR THE AGED, BLIND, AND DISABLED Determining Disability and Blindness Drug Addiction and... drug addiction or alcoholism in conformity with applicable Federal or State laws and regulations; (b... refer persons for treatment of drug addiction or alcoholism; (c) State licensed or certified care...

20 CFR 416.938 - What we mean by approved institutions or facilities.

Code of Federal Regulations, 2014 CFR

2014-04-01

... INCOME FOR THE AGED, BLIND, AND DISABLED Determining Disability and Blindness Drug Addiction and... drug addiction or alcoholism in conformity with applicable Federal or State laws and regulations; (b... refer persons for treatment of drug addiction or alcoholism; (c) State licensed or certified care...

Delivering Effective Instruction to Students with Deaf-Blindness and/or Other Severe Disabilities.

ERIC Educational Resources Information Center

North Carolina State Dept. of Public Instruction, Raleigh.

A guide to identifying, placing, and instructing children with severe disabilities, including deaf-blindness, is presented. Identification and placement information focuses on locating and referring children in need of special education services, the role of committees and staff members, the individualized education program, entrance and placement…

Deaf-Blindness: National Organizations and Resources. Reference Circular No. 93-1.

ERIC Educational Resources Information Center

Library of Congress, Washington, DC. National Library Service for the Blind and Physically Handicapped.

This circular lists national organizations and print and audiovisual resources on areas of service to persons with deaf blindness, including rehabilitation, education, information and referral, recreation, and sources for adaptive devices and products. Section I is an alphabetical list of 40 national organizations and resources, including…

On Praising Convergent Thinking: Creativity as Blind Variation and Selective Retention

ERIC Educational Resources Information Center

Simonton, Dean Keith

2015-01-01

Arthur Cropley (2006) emphasized the critical place that convergent thinking has in creativity. Although he briefly refers to the blind variation and selective retention (BVSR) theory of creativity, his discussion could not reflect the most recent theoretical and empirical developments in BVSR, especially the resulting combinatorial models.…

Sex Education for Deaf-Blind Youths and Adults.

ERIC Educational Resources Information Center

Ingraham, Cynthia L.; Vernon, McCay; Clemente, Brenda; Olney, Linda

2000-01-01

This article describes a model sex education program developed for youths and adults who are deafblind by the Helen Keller National Center for Deaf-Blind Youths and Adults. In addition, it also discusses major related issues and presents general recommendations and a resource for further information. (Contains 11 references.) (Author/CR)

Blind image quality assessment without training on human opinion scores

NASA Astrophysics Data System (ADS)

Mittal, Anish; Soundararajan, Rajiv; Muralidhar, Gautam S.; Bovik, Alan C.; Ghosh, Joydeep

2013-03-01

We propose a family of image quality assessment (IQA) models based on natural scene statistics (NSS), that can predict the subjective quality of a distorted image without reference to a corresponding distortionless image, and without any training results on human opinion scores of distorted images. These `completely blind' models compete well with standard non-blind image quality indices in terms of subjective predictive performance when tested on the large publicly available `LIVE' Image Quality database.

Clinical reinvestigation and linkage analysis in the family with Episkopi blindness (Norrie disease).

PubMed

Wolff, G; Mayerová, A; Wienker, T F; Atalianis, P; Ioannou, P; Warburg, M

1992-11-01

We present the results of a clinical and genetic reinvestigation of the Cypriot family affected by an X chromosomally inherited eye disease originally published by Taylor et al, who coined the term Episkopi blindness. The pedigree was extended to 160 members, including 16 affected males out of 48 males at risk for the disease, most of whom were seen by one of us (PA). Affected males are blind with no associated symptoms and apparently are not mentally retarded. Thirty-nine family members agreed to blood sampling for genetic investigations. RFLP analysis was performed using probes from the region known to be deleted in some Norrie patients and polymorphic markers (DXS77, DXS7, MAOA, DXS255) from the proximal short arm of the X chromosome. There was no deletion for any of the probes in the affected males. Linkage analysis yielded positive lod scores for all informative markers (Z (DXS255, theta = 0) = 6.54, Z (MAOA, theta = 0) = 2.23, Z (DXS7, theta = 0) = 2.13). Thus, the conclusion that Episkopi blindness and Norrie disease (NDP, MIM *310600) are the same entity based on clinical evidence is now reinforced by gene mapping.

Clinical reinvestigation and linkage analysis in the family with Episkopi blindness (Norrie disease).

PubMed Central

Wolff, G; Mayerová, A; Wienker, T F; Atalianis, P; Ioannou, P; Warburg, M

1992-01-01

We present the results of a clinical and genetic reinvestigation of the Cypriot family affected by an X chromosomally inherited eye disease originally published by Taylor et al, who coined the term Episkopi blindness. The pedigree was extended to 160 members, including 16 affected males out of 48 males at risk for the disease, most of whom were seen by one of us (PA). Affected males are blind with no associated symptoms and apparently are not mentally retarded. Thirty-nine family members agreed to blood sampling for genetic investigations. RFLP analysis was performed using probes from the region known to be deleted in some Norrie patients and polymorphic markers (DXS77, DXS7, MAOA, DXS255) from the proximal short arm of the X chromosome. There was no deletion for any of the probes in the affected males. Linkage analysis yielded positive lod scores for all informative markers (Z (DXS255, theta = 0) = 6.54, Z (MAOA, theta = 0) = 2.23, Z (DXS7, theta = 0) = 2.13). Thus, the conclusion that Episkopi blindness and Norrie disease (NDP, MIM *310600) are the same entity based on clinical evidence is now reinforced by gene mapping. Images PMID:1453434

Congenital blindness limits allocentric to egocentric switching ability.

PubMed

Ruggiero, Gennaro; Ruotolo, Francesco; Iachini, Tina

2018-03-01

Many everyday spatial activities require the cooperation or switching between egocentric (subject-to-object) and allocentric (object-to-object) spatial representations. The literature on blind people has reported that the lack of vision (congenital blindness) may limit the capacity to represent allocentric spatial information. However, research has mainly focused on the selective involvement of egocentric or allocentric representations, not the switching between them. Here we investigated the effect of visual deprivation on the ability to switch between spatial frames of reference. To this aim, congenitally blind (long-term visual deprivation), blindfolded sighted (temporary visual deprivation) and sighted (full visual availability) participants were compared on the Ego-Allo switching task. This task assessed the capacity to verbally judge the relative distances between memorized stimuli in switching (from egocentric-to-allocentric: Ego-Allo; from allocentric-to-egocentric: Allo-Ego) and non-switching (only-egocentric: Ego-Ego; only-allocentric: Allo-Allo) conditions. Results showed a difficulty in congenitally blind participants when switching from allocentric to egocentric representations, not when the first anchor point was egocentric. In line with previous results, a deficit in processing allocentric representations in non-switching conditions also emerged. These findings suggest that the allocentric deficit in congenital blindness may determine a difficulty in simultaneously maintaining and combining different spatial representations. This deficit alters the capacity to switch between reference frames specifically when the first anchor point is external and not body-centered.

NGC 4622:. A clear example of spiral density wave star formation unused in textbooks.

NASA Astrophysics Data System (ADS)

Byrd, Gene G.

2018-06-01

Refer to the poster HST images or to http://heritage.stsci.edu/2002/03/index.html. The top northeastern (NE) arm of NGC 4622 winds outward clockwise (CW) showing beautiful “ beads on a string” blue stellar associations on the CONCAVE SIDE of the arm. These are nicely offset CW in position from the density concentration of old yellow stars in the arms. The displacement would result from aggregation of gas clouds as they orbit CW into a more slowly turning stellar disk arm pattern. There is a time delay until the associations form and light up on the concave side. Farther inward along the top NE arm, the lit-up associations occur in the MIDDLE of the stellar arm. This is characteristic of the co-rotation (CR) radius where the CW orbital angular rate of the gas clouds and the arm CW pattern speeds match. Just within CR, the association displacement from the stellar arm is opposite (CCW) onto the CONVEX SIDE of the arm. A similar displacement sequence from concave (outside CR), middle (at CR) to convex (inside CR) is seen along the lower southwestern arm. Why isn’t NGC 4622 featured in textbooks? A rather puzzling single stellar arm winds outward CCW from the center, opposite to the outer pair. The eastern edge of the disk (marked by dust cloud silhouettes) is the nearer edge. The NE portion radial velocity is away relative to the nucleus so the disk orbital motion is CW. The outer pair of arms thus winds outward to LEAD in the same direction as the CW orbital motion, contrary to typical arm winding. Actually, the leading pair of arms and single inner arm would make NGC 4622 even better for use in introductory astronomy texts. Students can debate the origin of this galaxy's strange arm pattern which, ironically, matches density wave predictions so well. This is better than simply reading a textbook and thinking that all is explained. See G. G. Byrd; T. Freeman; S. Howard; R. J. Buta (2008). Astron. J., 135, p. 408–413 and references there for observations and hypotheses about NGC 4622’s arms. This work was supported by NSAS/STScI grant 8707 to the Univ. of Alabama and NSF grant AST 02-0177 to Bevill State College, Fayette, AL. Also see https://www.researchgate.net/profile/Gene_Byrd2

Standardisation of information submitted to an endpoint committee for cause of death assignment in a cancer screening trial – lessons learnt from CAP (Cluster randomised triAl of PSA testing for Prostate cancer).

PubMed

Williams, Naomi J; Hill, Elizabeth M; Ng, Siaw Yein; Martin, Richard M; Metcalfe, Chris; Donovan, Jenny L; Evans, Simon; Hughes, Laura J; Davies, Charlotte F; Hamdy, Freddie C; Neal, David E; Turner, Emma L

2015-01-23

In cancer screening trials where the primary outcome is target cancer-specific mortality, the unbiased determination of underlying cause of death (UCD) is crucial. To minimise bias, the UCD should be independently verified by expert reviewers, blinded to death certificate data and trial arm. We investigated whether standardising the information submitted for UCD assignment in a population-based randomised controlled trial of prostate-specific antigen (PSA) testing for prostate cancer reduced the reviewers' ability to correctly guess the trial arm. Over 550 General Practitioner (GP) practices (>415,000 men aged 50-69 years) were cluster-randomised to PSA testing (intervention arm) or the National Health Service (NHS) prostate cancer risk management programme (control arm) between 2001 and 2007. Assignment of UCD was by independent reviews of researcher-written clinical vignettes that masked trial arm and death certificate information. A period of time after the process began (the initial phase), we analysed whether the reviewers could correctly identify trial arm from the vignettes, and the reasons for their choice. This feedback led to further standardisation of information (second phase), after which we re-assessed the extent of correct identification of trial arm. 1099 assessments of 509 vignettes were completed by January 2014. In the initial phase (n = 510 assessments), reviewers were unsure of trial arm in 33% of intervention and 30% of control arm assessments and were influenced by symptoms at diagnosis, PSA test result and study-specific criteria. In the second phase (n = 589), the respective proportions of uncertainty were 45% and 48%. The percentage of cases whereby reviewers were unable to determine the trial arm was greater following the standardisation of information provided in the vignettes. The chances of a correct guess and an incorrect guess were equalised in each arm, following further standardisation. It is possible to mask trial arm from cause of death reviewers, by using their feedback to standardise the information submitted to them. ISRCTN92187251.

A pilot randomized controlled trial comparing effectiveness of prism glasses, visual search training and standard care in hemianopia.

PubMed

Rowe, F J; Conroy, E J; Bedson, E; Cwiklinski, E; Drummond, A; García-Fiñana, M; Howard, C; Pollock, A; Shipman, T; Dodridge, C; MacIntosh, C; Johnson, S; Noonan, C; Barton, G; Sackley, C

2017-10-01

Pilot trial to compare prism therapy and visual search training, for homonymous hemianopia, to standard care (information only). Prospective, multicentre, parallel, single-blind, three-arm RCT across fifteen UK acute stroke units. Stroke survivors with homonymous hemianopia. Arm a (Fresnel prisms) for minimum 2 hours, 5 days per week over 6 weeks. Arm b (visual search training) for minimum 30 minutes, 5 days per week over 6 weeks. Arm c (standard care-information only). Adult stroke survivors (>18 years), stable hemianopia, visual acuity better than 0.5 logMAR, refractive error within ±5 dioptres, ability to read/understand English and provide consent. Primary outcomes were change in visual field area from baseline to 26 weeks and calculation of sample size for a definitive trial. Secondary measures included Rivermead Mobility Index, Visual Function Questionnaire 25/10, Nottingham Extended Activities of Daily Living, Euro Qual, Short Form-12 questionnaires and Radner reading ability. Measures were post-randomization at baseline and 6, 12 and 26 weeks. Randomization block lists stratified by site and partial/complete hemianopia. Allocations disclosed to patients. Primary outcome assessor blind to treatment allocation. Eighty-seven patients were recruited: 27-Fresnel prisms, 30-visual search training and 30-standard care; 69% male; mean age 69 years (SD 12). At 26 weeks, full results for 24, 24 and 22 patients, respectively, were compared to baseline. Sample size calculation for a definitive trial determined as 269 participants per arm for a 200 degree 2 visual field area change at 90% power. Non-significant relative change in area of visual field was 5%, 8% and 3.5%, respectively, for the three groups. Visual Function Questionnaire responses improved significantly from baseline to 26 weeks with visual search training (60 [SD 19] to 68.4 [SD 20]) compared to Fresnel prisms (68.5 [SD 16.4] to 68.2 [18.4]: 7% difference) and standard care (63.7 [SD 19.4] to 59.8 [SD 22.7]: 10% difference), P=.05. Related adverse events were common with Fresnel prisms (69.2%; typically headaches). No significant change occurred for area of visual field area across arms over follow-up. Visual search training had significant improvement in vision-related quality of life. Prism therapy produced adverse events in 69%. Visual search training results warrant further investigation. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Video on Diet Before Outpatient Colonoscopy Does Not Improve Quality of Bowel Preparation: A Prospective, Randomized, Controlled Trial.

PubMed

Rice, Sean C; Higginbotham, Tina; Dean, Melanie J; Slaughter, James C; Yachimski, Patrick S; Obstein, Keith L

2016-11-01

Successful outpatient colonoscopy (CLS) depends on many factors including the quality of a patient's bowel preparation. Although education on consumption of the pre-CLS purgative can improve bowel preparation quality, no study has evaluated dietary education alone. We have created an educational video on pre-CLS dietary instructions to determine whether dietary education would improve outpatient bowel preparation quality. A prospective randomized, blinded, controlled study of patients undergoing outpatient CLS was performed. All patients received a 4 l polyethylene glycol-based split-dose bowel preparation and standard institutional pre-procedure instructions. Patients were then randomly assigned to an intervention arm or to a no intervention arm. A 4-min educational video detailing clear liquid diet restriction was made available to patients in the intervention arm, whereas those randomized to no intervention did not have access to the video. Patients randomized to the video were provided with the YouTube video link 48-72 h before CLS. An attending endoscopist blinded to randomization performed the CLS. Bowel preparation quality was scored using the Boston Bowel Preparation Scale (BBPS). Adequate preparation was defined as a BBPS total score of ≥6 with all segment scores ≥2. Wilcoxon rank-sum and Pearson's χ 2 -tests were performed to assess differences between groups. Ninety-two patients were randomized (video: n=42; control: n=50) with 47 total video views being tallied. There were no demographic differences between groups. There was no statistically significant difference in adequate preparation between groups (video=74%; control=68%; P=0.54). The availability of a supplementary patient educational video on clear liquid diet alone was insufficient to improve bowel preparation quality when compared with standard pre-procedure instruction at our institution.

Probiotic administration among free-living older adults: a double blinded, randomized, placebo-controlled clinical trial.

PubMed

Östlund-Lagerström, Lina; Kihlgren, Annica; Repsilber, Dirk; Björkstén, Bengt; Brummer, Robert J; Schoultz, Ida

2016-09-10

Diseases of the digestive system have been found to contribute to a higher symptom burden in older adults. Thus, therapeutic strategies able to treat gastrointestinal discomfort might impact the overall health status and help older adults to increase their overall health status and optimal functionality. The aim of this double-blinded, randomized, placebo-controlled clinical trial was to evaluate the effect of the probiotic strain Lactobacillus reuteri on digestive health and wellbeing in older adults. The study enrolled general older adults (>65 years). After eligibility screening qualified subjects (n = 290) participated in a 2-arm study design, with each arm consisting of 12 weeks of intervention of either active or placebo product. Primary outcome measure was set to changes in gastrointestinal symptoms and secondary outcome measures were changes in level of wellbeing, anxiety and stress. Follow up was performed at 8 and 12 weeks. No persistent significant effects were observed on the primary or secondary outcome parameters of the study. A modest effect was observed in the probiotic arm, were levels of stress decreased at week 8 and 12. Similarly, we found that subjects suffering from indigestion and abdominal pain, respectively, showed a significant decrease of anxiety at week 8 after probiotic treatment, but not at week 12. The RCT failed to show any improvement in digestive health after daily intake of a probiotic supplement containing L. reuteri. Neither was any significant improvement in wellbeing, stress or anxiety observed. Even though the RCT had a negative outcome, the study highlights issues important to take into consideration when designing trials among older adults. Clinicaltrials.gov/ NCT01837940 .

A preliminary placebo-controlled crossover trial of fludrocortisone for chronic fatigue syndrome.

PubMed

Peterson, P K; Pheley, A; Schroeppel, J; Schenck, C; Marshall, P; Kind, A; Haugland, J M; Lambrecht, L J; Swan, S; Goldsmith, S

1998-04-27

To provide a preliminary assessment of the efficacy and safety of fludrocortisone acetate treatment of chronic fatigue syndrome. A placebo-controlled, double-blind, random-allocation crossover trial of 6 weeks of fludrocortisone. An outpatient clinical trials unit. Twenty-five participants with chronic fatigue syndrome (mean age, 40 years; 19 [76%] women; mean duration of illness, 7.0 years) were recruited from a research and clinic registry. Five patients withdrew from the trial. All participants were scheduled to receive fludrocortisone acetate (0.1-0.2 mg) or a placebo for 6 weeks in each treatment. Self-administered questionnaires were completed at the beginning and end of each treatment arm that asked patients to rate the severity of their symptoms on a visual analogue scale. The Medical Outcomes Study 36-Item Short-Form Health Survey, a reaction time test, and a treadmill exercise test were used to assess functional status. Blood pressure, heart rate, and plasma norepinephrine levels were obtained at baseline. Blood pressure and heart rate were recorded at the end of the exercise test and monitored at all subsequent visits. At baseline, the study participants reported symptom severity greater than 5 for most symptoms, and all had evidence of marked functional impairments. No improvement was observed in the severity of any symptom or in any test of function for the 20 participants who completed both arms of the trial. Blood pressure and heart rate readings were unaffected by treatment, and plasma norepinephrine levels did not differ from those of a healthy control group. The incidence of adverse experiences was similar in the fludrocortisone and placebo arms of the trial. Low-dose fludrocortisone does not provide sufficient benefit to be evident in a preliminary blinded trial of unselected patients with chronic fatigue syndrome.

A Prospective, Randomized, Double-Blind Multicenter Study Comparing Continuous Diffusion of Oxygen Therapy to Sham Therapy in the Treatment of Diabetic Foot Ulcers.

PubMed

Niederauer, Mark Q; Michalek, Joel E; Armstrong, David G

2017-09-01

Over the past generation, preclinical data have suggested that there is a potential physiologic benefit to applying oxygen topically to wounds. However, we are unaware of any studies in the literature that have robustly assessed whether this would lead to a higher proportion of healing in similarly treated people without oxygen. Therefore, the purpose of this study was to assess this in people being treated for chronic diabetic foot ulcers (DFUs). We enrolled and randomized 100 subjects with DFUs (79% male, aged 58.3 ± 12.1 years) to receive either active continuous diffusion of oxygen (CDO) therapy using an active CDO device, or an otherwise fully operational sham device that provided moist wound therapy (MWT) without delivering oxygen. Patients were followed until closure or 12 weeks, whichever was sooner. Patients, treating physicians and independent evaluators were blinded to the study arm. All patients received identical offloading, dressings and follow-up. There were no significant differences in assessed descriptive characteristics between the treatment arms ( P > .05 for all). A significantly higher proportion of people healed in the active arm compared to sham (46% vs 22%, P = .02). This relative effect became greater in more chronic wounds (42.5% vs 13.5%, P = .006). Patients randomized to the active device experienced significantly faster rates of closure relative to the sham ( P < .001). The results of this study suggest that continuously diffused oxygen over a wound leads to significantly higher rates of closure, and faster time to closure, compared to similarly treated patients receiving standard therapy coupled with a sham device. Furthermore, the relative efficacy appears to improve the more the therapy may be needed (more chronic and larger wounds).

Diagnostic ultrasound imaging for lateral epicondylalgia: a case-control study.

PubMed

Heales, Luke James; Broadhurst, Nathan; Mellor, Rebecca; Hodges, Paul William; Vicenzino, Bill

2014-11-01

Lateral epicondylalgia (LE) is clinically diagnosed as pain over the lateral elbow that is provoked by gripping. Usually, LE responds well to conservative intervention; however, those who fail such treatment require further evaluation, including musculoskeletal ultrasound. Previous studies of musculoskeletal ultrasound have methodological flaws, such as lack of assessor blinding and failure to control for participant age, sex, and arm dominance. The purpose of this study was to assess the diagnostic use of blinded ultrasound imaging in people with clinically diagnosed LE compared with that in a control group matched for age, sex, and arm dominance. Participants (30 with LE and 30 controls) underwent clinical examination as the criterion standard test. Unilateral LE was defined as pain over the lateral epicondyle, which was provoked by palpation, resisted wrist and finger extension, and gripping. Controls without symptoms were matched for age, sex, and arm dominance. Ultrasound investigations were performed by two sonographers using a standardized protocol. Grayscale images were assessed for signs of tendon pathology and rated on a four-point ordinal scale. Power Doppler was used to assess neovascularity and rated on a five-point ordinal scale. The combination of grayscale and power Doppler imaging revealed an overall sensitivity of 90% and specificity of 47%. The positive and negative likelihood ratios for combined grayscale and power Doppler imaging were 1.69 and 0.21, respectively. Although ultrasound imaging helps confirm the absence of LE, when findings are negative for tendinopathic changes, the high prevalence of tendinopathic changes in pain-free controls challenges the specificity of the measure. The validity of ultrasound imaging to confirm tendon pathology in clinically diagnosed LE requires further study with strong methodology.

Effect of two contrasting interventions on upper limb chronic pain and disability: a randomized controlled trial.

PubMed

Sundstrup, Emil; Jakobsen, Markus D; Andersen, Christoffer H; Jay, Kenneth; Persson, Roger; Aagaard, Per; Andersen, Lars L

2014-01-01

Chronic pain and disability of the arm, shoulder, and hand severely affect labor market participation. Ergonomic training and education is the default strategy to reduce physical exposure and thereby prevent aggravation of pain. An alternative strategy could be to increase physical capacity of the worker by physical conditioning. To investigate the effect of 2 contrasting interventions, conventional ergonomic training (usual care) versus resistance training, on pain and disability in individuals with upper limb chronic pain exposed to highly repetitive and forceful manual work. Examiner-blinded, parallel-group randomized controlled trial with allocation concealment. Slaughterhouses located in Denmark, Europe. Sixty-six adults with chronic pain in the shoulder, elbow/forearm, or hand/wrist and work disability were randomly allocated to 10 weeks of specific resistance training for the shoulder, arm, and hand muscles for 3 x 10 minutes per week, or ergonomic training and education (usual care control group). Pain intensity (average of shoulder, arm, and hand, scale 0 - 10) was the primary outcome, and disability (Work module of DASH questionnaire) as well as isometric shoulder and wrist muscle strength were secondary outcomes. Pain intensity, disability, and muscle strength improved more following resistance training than usual care (P < 0.001, P = 0.05, P <0.0001, respectively [corrected]). Pain intensity decreased by 1.5 points (95% confidence interval -2.0 to -0.9) following resistance training compared with usual care, corresponding to an effect size of 0.91 (Cohen's d). Blinding of participants is not possible in behavioral interventions. However, at baseline outcome expectations of the 2 interventions were similar. Resistance training at the workplace results in clinical relevant improvements in pain, disability, and muscle strength in adults with upper limb chronic pain exposed to highly repetitive and forceful manual work. NCT01671267.

Tranexamic Acid versus Placebo to Prevent Blood Transfusion during Radical Cystectomy for Bladder Cancer (TACT): Study Protocol for a Randomized Controlled Trial.

PubMed

Breau, Rodney H; Lavallée, Luke T; Cnossen, Sonya; Witiuk, Kelsey; Cagiannos, Ilias; Momoli, Franco; Bryson, Gregory; Kanji, Salmaan; Morash, Christopher; Turgeon, Alexis; Zarychanski, Ryan; Mallick, Ranjeeta; Knoll, Greg; Fergusson, Dean A

2018-05-02

Radical cystectomy for bladder cancer is associated with a high risk of needing red blood cell transfusion. Tranexamic acid reduces blood loss during cardiac and orthopedic surgery, but no study has yet evaluated tranexamic acid use during cystectomy. A randomized, double-blind (surgeon-, anesthesiologist-, patient-, data-monitor-blinded), placebo-controlled trial of tranexamic acid during cystectomy was initiated in June 2013. Prior to incision, the intervention arm participants receive a 10 mg/kg loading dose of intravenously administered tranexamic acid, followed by a 5 mg/kg/h maintenance infusion. In the control arm, the patient receives an identical volume of normal saline that is indistinguishable from the intervention. The primary outcome is any blood transfusion from the start of surgery up to 30 days post operative. There are no strict criteria to mandate the transfusion of blood products. The decision to transfuse is entirely at the discretion of the treating physicians who are blinded to patient allocation. Physicians are allowed to utilize all resources to make transfusion decisions, including serum hemoglobin concentration and vital signs. To date, 147 patients of a planned 354 have been randomized to the study. This protocol reviews pertinent data relating to blood transfusion during radical cystectomy, highlighting the need to identify methods for reducing blood loss and preventing transfusion in patients receiving radical cystectomy. It explains the clinical rationale for using tranexamic acid to reduce blood loss during cystectomy, and outlines the study methods of our ongoing randomized controlled trial. Canadian Institute for Health Research (CIHR) Protocol: MOP-342559; ClinicalTrials.gov, ID: NCT01869413. Registered on 5 June 2013.

Randomized, multicenter, dose-ranging trial of retigabine for partial-onset seizures.

PubMed

Porter, R J; Partiot, A; Sachdeo, R; Nohria, V; Alves, W M

2007-04-10

To evaluate the efficacy and safety of retigabine 600, 900, and 1,200 mg/day administered three times daily as adjunctive therapy in patients with partial-onset seizures. A multicenter, randomized, double-blind, placebo-controlled trial was performed. After an 8-week baseline phase, patients were randomized to a 16-week double-blind treatment period (8-week forced titration and 8-week maintenance) followed by either tapering or entry into an open-label extension study. Primary efficacy was the percentage change from baseline in monthly seizure frequency and compared across treatment arms. Secondary efficacy comparisons included the proportion of patients experiencing >/=50% reduction in seizure frequency (responder rate), emergence of new seizure types, and physician assessment of global clinical improvement. Safety/tolerability assessments included adverse events (AEs), physical and neurologic examinations, and clinical laboratory evaluations. Efficacy analyses were performed on the intent-to-treat population. Of the 399 randomized patients, 279 (69.9%) completed the double-blind treatment period. The median percent change in monthly total partial seizure frequency from baseline was -23% for 600 mg/day, -29% for 900 mg/day, and -35% for 1,200 mg/day vs -13% for placebo (p < 0.001 for overall difference across all treatment arms). Responder rates for retigabine were 23% for 600 mg/day, 32% for 900 mg/day (p = 0.021), and 33% for 1,200 mg/day (p = 0.016), vs 16% for placebo. The most common treatment-emergent AEs were somnolence, dizziness, confusion, speech disorder, vertigo, tremor, amnesia, abnormal thinking, abnormal gait, paresthesia, and diplopia. Adjunctive therapy with retigabine is well tolerated and reduces the frequency of partial-onset seizures in a dose-dependent manner.

Posture and Movement

NASA Technical Reports Server (NTRS)

1997-01-01

Session TP3 includes short reports on: (1) Modification of Goal-Directed Arm Movements During Inflight Adaptation to Microgravity; (2) Quantitative Analysis of Motion control in Long Term Microgravity; (3) Does the Centre of Gravity Remain the Stabilised Reference during Complex Human Postural Equilibrium Tasks in Weightlessness?; and (4) Arm End-Point Trajectories Under Normal and Microgravity Environments.

Learning for a Bright Future: Schooling, Armed Conflict, and Children's Well-Being

ERIC Educational Resources Information Center

Winthrop, Rebecca; Kirk, Jackie

2008-01-01

During and after armed conflicts, policy makers and practitioners often advocate education to support the physical, psychological, and social well-being of children. In such advocacy they reference education's role in promoting children's welfare, although there is evidence that schooling in particular can jeopardize children's well-being. In this…

FDTD calculations of SAR for child voxel models in different postures between 10 MHz and 3 GHz.

PubMed

Findlay, R P; Lee, A-K; Dimbylow, P J

2009-08-01

Calculations of specific energy absorption rate (SAR) have been performed on the rescaled NORMAN 7-y-old voxel model and the Electronics and Telecommunications Research Institute (ETRI) child 7-y-old voxel model in the standing arms down, arms up and sitting postures. These calculations were for plane-wave exposure under isolated and grounded conditions between 10 MHz and 3 GHz. It was found that there was little difference at each resonant frequency between the whole-body averaged SAR values calculated for the NORMAN and ETRI 7-y-old models for each of the postures studied. However, when compared with the arms down posture, raising the arms increased the SAR by up to 25%. Electric field values required to produce the International Commission on Non-Ionizing Radiation Protection and Institute of Electrical and Electronic Engineers public basic restriction were calculated, and compared with reference levels for the different child models and postures. These showed that, under certain worst-case exposure conditions, the reference levels may not be conservative.

Limb position sense, proprioceptive drift and muscle thixotropy at the human elbow joint

PubMed Central

Tsay, A; Savage, G; Allen, T J; Proske, U

2014-01-01

These experiments on the human forearm are based on the hypothesis that drift in the perceived position of a limb over time can be explained by receptor adaptation. Limb position sense was measured in 39 blindfolded subjects using a forearm-matching task. A property of muscle, its thixotropy, a contraction history-dependent passive stiffness, was exploited to place muscle receptors of elbow muscles in a defined state. After the arm had been held flexed and elbow flexors contracted, we observed time-dependent changes in the perceived position of the reference arm by an average of 2.8° in the direction of elbow flexion over 30 s (Experiment 1). The direction of the drift reversed after the arm had been extended and elbow extensors contracted, with a mean shift of 3.5° over 30 s in the direction of elbow extension (Experiment 2). The time-dependent changes could be abolished by conditioning elbow flexors and extensors in the reference arm at the test angle, although this led to large position errors during matching (±10°), depending on how the indicator arm had been conditioned (Experiments 3 and 4). When slack was introduced in the elbow muscles of both arms, by shortening muscles after the conditioning contraction, matching errors became small and there was no drift in position sense (Experiments 5 and 6). These experiments argue for a receptor-based mechanism for proprioceptive drift and suggest that to align the two forearms, the brain monitors the difference between the afferent signals from the two arms. PMID:24665096

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.

Evaluation of amplification refractory mutation system (ARMS) technique for quick and accurate prenatal gene diagnosis of CHM variant in choroideremia.

PubMed

Yang, Lisha; Ijaz, Iqra; Cheng, Jingliang; Wei, Chunli; Tan, Xiaojun; Khan, Md Asaduzzaman; Fu, Xiaodong; Fu, Junjiang

2018-01-01

Choroideremia is a rare X-linked recessive inherited disorder that causes chorioretinal dystrophy leading to visual impairment in its early stages which finally causes total blindness in the affected person. It is caused due to mutations in the CHM gene. In this study, we have recruited a pedigree with choroideremia and detected a nonsense variant (c.C799T:p.R267X) in CHM of the proband (I:1). Different primer sets for amplification refractory mutation system (ARMS) were designed and PCR conditions were optimized. Then, we evaluated the sequence variant in the patient, carrier, and a fetus by using ARMS technique to identify if they inherited the pathogenic gene from parental generation; we used amniotic fluid DNA for the diagnosis of the gene in the fetus. The primer pairs, WT2+C and MT+C, amplified high specific products in different DNAs which were verified by Sanger sequencing. Based on our results, ARMS technique is fast, accurate, and reliable prenatal gene diagnostic tool to assess CHM variants. Taken together, our study indicates that ARMS technique can be used as a potential molecular tool in the diagnosis of prenatal mutation for choroideremia as well as other genetic diseases in undeveloped and developing countries, where there might be shortage of medical resources and supplies.

Individual differences in susceptibility to inattentional blindness.

PubMed

Seegmiller, Janelle K; Watson, Jason M; Strayer, David L

2011-05-01

Inattentional blindness refers to the finding that people do not always see what appears in their gaze. Though inattentional blindness affects large percentages of people, it is unclear if there are individual differences in susceptibility. The present study addressed whether individual differences in attentional control, as reflected by variability in working memory capacity, modulate susceptibility to inattentional blindness. Participants watched a classic inattentional blindness video (Simons & Chabris, 1999) and were instructed to count passes among basketball players, wherein 58% noticed the unexpected: a person wearing a gorilla suit. When participants were accurate with their pass counts, individuals with higher working memory capacity were more likely to report seeing the gorilla (67%) than those with lesser working memory capacity (36%). These results suggest that variability in attentional control is a potential mechanism underlying the apparent modulation of inattentional blindness across individuals.

Teaching Life Sciences to Blind and Visually Impaired Learners

ERIC Educational Resources Information Center

Fraser, William John; Maguvhe, Mbulaheni Obert

2008-01-01

This study reports on the teaching of life sciences (biology) to blind and visually impaired learners in South Africa at 11 special schools with specific reference to the development of science process skills in outcomes-based classrooms. Individual structured interviews were conducted with nine science educators teaching at the different special…

ICT in Portuguese Reference Schools for the Education of Blind and Partially Sighted Students

ERIC Educational Resources Information Center

Ramos, Sara Isabel Moca; de Andrade, António Manuel Valente

2016-01-01

Technology has become an essential component in our society and considering its impact in the educational system, Information and Communication Technologies (ICT) cannot be dissociated from the educational process and, in particular, from pedagogical practices adopted for students who are blind or partially sighted. This study focuses on…

Fixing methods for the use of optical fibers in interferometric arrangements

NASA Astrophysics Data System (ADS)

Cubik, Jakub; Kepak, Stanislav; Fajkus, Marcel; Zboril, Ondrej; Nedoma, Jan; Davidson, Alan; Vasinek, Vladimir

2016-12-01

Today interferometric sensors are among the most accurate available thanks to their inherent high sensitivity. These highly versatile sensors may be used to measure phenomena such as temperature, strain, fluid level, flow, vibration, stress, etc. This article concentrates on the composition of fiber-optic interferometers, in particular the Mach-Zehnder type. The Mach-Zehnder type is composed of two arms, one for measurement and a second serving as a reference. When light enters the interferometer, ideally the phase of the light is shifted only in the measurement arm while the phase in the second arm remains unchanged. Interference occurs when the light recombining at the output and the resulting light intensity is proportional to the measurand. A major issue in the application of fiber based sensors is laying and fixing the fibers effectively in real life environments. Different approaches are necessary for both arms. The reference arm should as far as possible be isolated from the measurand. In this paper, various isolating materials are considered, however there are almost unlimited materials that may be used for isolation purposes. Conventional construction methods and materials were used such as aluminum tubing, flexible PVC tubing, double sided tape, steel clinches, superglue, PVC strips and PVC strips filled by silicon.

Effects of visual information regarding allocentric processing in haptic parallelity matching.

PubMed

Van Mier, Hanneke I

2013-10-01

Research has revealed that haptic perception of parallelity deviates from physical reality. Large and systematic deviations have been found in haptic parallelity matching most likely due to the influence of the hand-centered egocentric reference frame. Providing information that increases the influence of allocentric processing has been shown to improve performance on haptic matching. In this study allocentric processing was stimulated by providing informative vision in haptic matching tasks that were performed using hand- and arm-centered reference frames. Twenty blindfolded participants (ten men, ten women) explored the orientation of a reference bar with the non-dominant hand and subsequently matched (task HP) or mirrored (task HM) its orientation on a test bar with the dominant hand. Visual information was provided by means of informative vision with participants having full view of the test bar, while the reference bar was blocked from their view (task VHP). To decrease the egocentric bias of the hands, participants also performed a visual haptic parallelity drawing task (task VHPD) using an arm-centered reference frame, by drawing the orientation of the reference bar. In all tasks, the distance between and orientation of the bars were manipulated. A significant effect of task was found; performance improved from task HP, to VHP to VHPD, and HM. Significant effects of distance were found in the first three tasks, whereas orientation and gender effects were only significant in tasks HP and VHP. The results showed that stimulating allocentric processing by means of informative vision and reducing the egocentric bias by using an arm-centered reference frame led to most accurate performance on parallelity matching. © 2013 Elsevier B.V. All rights reserved.

Decision Aid to Technologically Enhance Shared decision making (DATES): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Clinicians face challenges in promoting colorectal cancer screening due to multiple competing demands. A decision aid that clarifies patient preferences and improves decision quality can aid shared decision making and be effective at increasing colorectal cancer screening rates. However, exactly how such an intervention improves shared decision making is unclear. This study, funded by the National Cancer Institute, seeks to provide detailed understanding of how an interactive decision aid that elicits patient’s risks and preferences impacts patient-clinician communication and shared decision making, and ultimately colorectal cancer screening adherence. Methods/Design This is a two-armed single-blinded randomized controlled trial with the target of 300 patients per arm. The setting is eleven community and three academic primary care practices in Metro Detroit. Patients are men and women aged between 50 and 75 years who are not up to date on colorectal cancer screening. ColoDATES Web (intervention arm), a decision aid that incorporates interactive personal risk assessment and preference clarification tools, is compared to a non-interactive website that matches ColoDATES Web in content but does not contain interactive tools (control arm). Primary outcomes are patient uptake of colorectal cancer screening; patient decision quality (knowledge, preference clarification, intent); clinician’s degree of shared decision making; and patient-clinician concordance in the screening test chosen. Secondary outcome incorporates a Structural Equation Modeling approach to understand the mechanism of the causal pathway and test the validity of the proposed conceptual model based on Theory of Planned Behavior. Clinicians and those performing the analysis are blinded to arms. Discussion The central hypothesis is that ColoDATES Web will improve colorectal cancer screening adherence through improvement in patient behavioral factors, shared decision making between the patient and the clinician, and concordance between the patient’s and clinician’s preferred colorectal cancer screening test. The results of this study will be among the first to examine the effect of a real-time preference assessment exercise on colorectal cancer screening and mediators, and, in doing so, will shed light on the patient-clinician communication and shared decision making ‘black box’ that currently exists between the delivery of decision aids to patients and subsequent patient behavior. Trial Registration ClinicalTrials.gov ID NCT01514786 PMID:24216139

Slow-release L-Cysteine (Acetium®) Lozenge Is an Effective New Method in Smoking Cessation. A Randomized, Double-blind, Placebo-controlled Intervention.

PubMed

Syrjänen, Kari; Eronen, Katja; Hendolin, Panu; Paloheimo, Lea; Eklund, Carita; Bäckström, Anna; Suovaniemi, Osmo

2017-07-01

Because of the major health problems and annual economic burden caused by cigarette smoking, effective new tools for smoking intervention are urgently needed. Our previous randomized controlled trial (RCT) provided promising results on the efficacy of slow-release L-cysteine lozenge in smoking intervention, but the study was not adequately powered. To confirm in an adequately-powered study the results of the previous RCT implicating that effective elimination of acetaldehyde in saliva by slow-release L-cysteine (Acetium® lozenge, Biohit Oyj, Helsinki), would assist in smoking cessation by reducing acetaldehyde-enhanced nicotine addiction. On this matter, we undertook a double-blind, randomized, placebo-controlled trial comparing Acetium® lozenge and placebo in smoking intervention. A cohort of 1,998 cigarette smokers were randomly allocated to intervention (n=996) and placebo arms (n=1,002). At baseline, smoking history was recorded by a questionnaire, with nicotine dependence testing according to the Fagerström scale (FTND). The subjects used smoking diary recording the daily numbers of cigarettes, lozenges and subjective sensations of smoking. The data were analysed separately for point prevalence of abstinence (PPA) and prolonged abstinence (PA) endpoints. Altogether, 753 study subjects completed the trial per protocol (PP), 944 with violations (mITT), and the rest (n=301) were lost to follow-up (LTF). During the 6-month intervention, 331 subjects stopped smoking; 181 (18.2%) in the intervention arm and 150 (15.0%) in the placebo arm (OR=1.43; 95%CI=1.09-1.88); p=0.010). In the PP group, 170 (45.3%) quitted smoking in the intervention arm compared to 134 (35.4%) in the placebo arm (OR=1.51, 95%CI=1.12-2.02; p=0.006). In multivariate (Poisson regression) model, decreased level of smoking pleasure (p=0.010) and "smoking sensations changed" were powerful independent predictors of quit events (IRR=12.01; 95%CI=1.5-95.6). Acetium® lozenge, herein confirmed in an adequately powered study to be an effective means to aid smoking quit, represents a major breakthrough in the development of smoking intervention methods, because slow-release L-cysteine is non-toxic, with no side-effects or limitations of use. Copyright© 2017, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

Effects of Altering Levothyroxine (L-T4) Doses on Quality of Life, Mood, and Cognition in L-T4 Treated Subjects.

PubMed

Samuels, Mary H; Kolobova, Irina; Niederhausen, Meike; Janowsky, Jeri S; Schuff, Kathryn G

2018-05-01

The brain is a critical target organ for thyroid hormone, but it is unclear whether variations in thyroid function within and near the reference range affect quality of life, mood, or cognition. A total of 138 subjects with levothyroxine (L-T4)-treated hypothyroidism and normal thyrotropin (TSH) levels underwent measures of quality of life (36-Item Short Form Health Survey, Underactive Thyroid-Dependent Quality of Life Questionnaire), mood (Profile of Mood States, Affective Lability Scale), and cognition (executive function, memory). They were then randomly assigned to receive an unchanged, higher, or lower L-T4 dose in double-blind fashion, targeting one of three TSH ranges (0.34 to 2.50, 2.51 to 5.60, or 5.61 to 12.0 mU/L). Doses were adjusted every 6 weeks based on TSH levels. Baseline measures were reassessed at 6 months. At the end of the study, by intention to treat, mean L-T4 doses were 1.50 ± 0.07, 1.32 ± 0.07, and 0.78 ± 0.08 μg/kg (P < 0.001), and mean TSH levels were 1.85 ± 0.25, 3.93 ± 0.38, and 9.49 ± 0.80 mU/L (P < 0.001), respectively, in the three arms. There were minor differences in a few outcomes between the three arms, which were no longer significant after correction for multiple comparisons. Subjects could not ascertain how their L-T4 doses had been adjusted (P = 0.55) but preferred L-T4 doses they perceived to be higher (P < 0.001). Altering L-T4 doses in hypothyroid subjects to vary TSH levels in and near the reference range does not affect quality of life, mood, or cognition. L-T4-treated subjects prefer perceived higher L-T4 doses despite a lack of objective benefit. Adjusting L-T4 doses in hypothyroid patients based on symptoms in these areas may not result in significant clinical improvement.

Reliability and Usefulness of Intraoperative 3-Dimensional Imaging by Mobile C-Arm With Flat-Panel Detector.

PubMed

Fujimori, Takahito; Iwasaki, Motoki; Nagamoto, Yukitaka; Kashii, Masafumi; Takao, Masaki; Sugiura, Tsuyoshi; Yoshikawa, Hideki

2017-02-01

Reliability and agreement study. To assess the reliability of intraoperative 3-dimensional imaging with a mobile C-arm (3D C-arm) equipped with a flat-panel detector. Pedicle screws are widely used in spinal surgery. Postoperative computed tomography (CT) is the most reliable method to detect screw misplacement. Recent advances in imaging devices have enabled surgeons to acquire 3D images of the spine during surgery. However, the reliability of these imaging devices is not known. A total of 203 screws were used in 22 consecutive patients who underwent surgery for scoliosis. Screw position was read twice with a 3D C-arm and twice with CT in a blinded manner by 2 independent observers. Screw positions were classified into 4 categories at every 2 mm and then into 2 simpler categories of acceptable or unacceptable. The degree of agreement with respect to screw positions between the double readings was evaluated by κ value. With unanimous agreement between 2 observers regarding postoperative CT readings considered the gold standard, the sensitivity of the 3D C-arm for determining screw misplacement was calculated. A total 804 readings were performed. For the 4-category classification, the mean κ value for the 2 interobserver readings was 0.52 for the 3D C-arm and 0.46 for CT. For the 2-category classification, the mean κ value for the 2 interobserver readings was 0.80 for the 3D C-arm and 0.66 for CT. The sensitivity, specificity, positive predictive value, and negative predictive value of intraoperative imaging with the 3D C-arm were 70%, 95%, 44%, and 98%, respectively. With respect to screws with perforation ≥4 mm, the sensitivity was 83%. No revision surgery was performed. Intraoperative imaging with a 3D C-arm was reliable for detecting screw misplacement and helpful in decreasing the rate of revision surgery for screw misplacement.

Safety and Effectiveness of BufferGel and 0.5% PRO2000 Gel for the Prevention of HIV Infection in Women

PubMed Central

Karim, Salim S Abdool; Richardson, Barbra A; Ramjee, Gita; Hoffman, Irving F; Chirenje, Zvavahera M; Taha, Taha; Kapina, Muzala; Maslankowski, Lisa; Coletti, Anne; Profy, Albert; Moench, Thomas R.; Piwowar-Manning, Estelle; Mâsse, Benoît; Hillier, Sharon L.; Soto-Torres, Lydia

2011-01-01

Objective To determine the safety and effectiveness of BufferGel and 0.5% PRO2000 microbicide gels for the prevention of male to female HIV transmission Design Phase II/IIb, randomized, placebo-controlled trial with three double-blinded gel arms and an open label no gel arm. Methods Study participants from Malawi, South Africa, Zambia, Zimbabwe and USA were instructed to apply study gel ≤1 hour before each sex act and safety, sexual behavior, pregnancy, gel adherence, acceptability, and HIV serostatus were assessed during follow-up. Results The 3101 enrolled women were followed for an average of 20.4 months with 93.6% retention and 81.1% self-reported gel adherence. Adverse event rates were similar in all study arms. HIV incidence rates in the 0.5% PRO2000 Gel, BufferGel, Placebo Gel and No Gel arms were 2.70, 4.14, 3.91 and 4.02 per 100 women-years, respectively. HIV incidence in the 0.5% PRO2000 Gel arm was lower than the Placebo Gel arm (Hazard Ratio (HR)=0.7; p=0.10) and the No Gel arm (HR=0.67; p=0.06). HIV incidence rates were similar in the BufferGel and both Placebo Gel (HR=1.10; p=0.63) and No Gel control arms (HR=1.05; p=0.78). HIV incidence was similar in the Placebo Gel and No Gel arms (HR=0.97; p=0.89). Conclusions 0.5% PRO2000 Gel demonstrated a modest 30% reduction in HIV acquisition in women. However, these results were not statistically significant and subsequent findings from the MDP 301 trial have confirmed that 0.5% PRO2000 has little or no protective effect. BufferGel did not alter the risk of HIV infection. Both products were safe. PMID:21330907

The nuclear present. A guide to recent books on nuclear war, weapons, the peace movement, and related issues, with a chronology of nuclear events, 1789-1991

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

Burns, G.

The Nuclear Present brings the interested reader up-to-date on significant English-language books about nuclear weapons and related topics, identifying primarily important works of nuclear non-fiction that have come out since 1984. Each reference has a paragraph of comment about its subject and value. General organizational areas include the following: Reference Works; Nuclear weapons and Nuclear war (14 sub-headings including overviews, development, effects, tests, arms race, prospectives, legal considerations etc.); Strategy; proliferation; Stratigic Defense; Arms control and disarmament; ethical, pholosophical and religous perspectives; new paths to peace; periodic guide; the Chernobyl Disaster. An extensive Nuclear Chronology (1789-1991) written by the authormore » allows a fairly detailed sense of the historical record of nuclear weapons, including testing, manufacture, use and movements for arms control and disarmament.« less

A Validation Study of the Rank-Preserving Structural Failure Time Model: Confidence Intervals and Unique, Multiple, and Erroneous Solutions.

PubMed

Ouwens, Mario; Hauch, Ole; Franzén, Stefan

2018-05-01

The rank-preserving structural failure time model (RPSFTM) is used for health technology assessment submissions to adjust for switching patients from reference to investigational treatment in cancer trials. It uses counterfactual survival (survival when only reference treatment would have been used) and assumes that, at randomization, the counterfactual survival distribution for the investigational and reference arms is identical. Previous validation reports have assumed that patients in the investigational treatment arm stay on therapy throughout the study period. To evaluate the validity of the RPSFTM at various levels of crossover in situations in which patients are taken off the investigational drug in the investigational arm. The RPSFTM was applied to simulated datasets differing in percentage of patients switching, time of switching, underlying acceleration factor, and number of patients, using exponential distributions for the time on investigational and reference treatment. There were multiple scenarios in which two solutions were found: one corresponding to identical counterfactual distributions, and the other to two different crossing counterfactual distributions. The same was found for the hazard ratio (HR). Unique solutions were observed only when switching patients were on investigational treatment for <40% of the time that patients in the investigational arm were on treatment. Distributions other than exponential could have been used for time on treatment. An HR equal to 1 is a necessary but not always sufficient condition to indicate acceleration factors associated with equal counterfactual survival. Further assessment to distinguish crossing counterfactual curves from equal counterfactual curves is especially needed when the time that switchers stay on investigational treatment is relatively long compared to the time direct starters stay on investigational treatment.

49 CFR 572.73 - Neck assembly and test procedure.

Code of Federal Regulations, 2011 CFR

2011-10-01

... rotate, while translating in the direction of the pendulum preimpact flight, in reference to the pendulum... displacement at time “T” is defined as the straight line distance between the position relative to the pendulum arm of the head's center of gravity at time “zero;” and the position relative to the pendulum arm of...

49 CFR 572.73 - Neck assembly and test procedure.

Code of Federal Regulations, 2013 CFR

2013-10-01

... rotate, while translating in the direction of the pendulum preimpact flight, in reference to the pendulum... displacement at time “T” is defined as the straight line distance between the position relative to the pendulum arm of the head's center of gravity at time “zero;” and the position relative to the pendulum arm of...

49 CFR 572.73 - Neck assembly and test procedure.

Code of Federal Regulations, 2010 CFR

2010-10-01

... rotate, while translating in the direction of the pendulum preimpact flight, in reference to the pendulum... displacement at time “T” is defined as the straight line distance between the position relative to the pendulum arm of the head's center of gravity at time “zero;” and the position relative to the pendulum arm of...

49 CFR 572.73 - Neck assembly and test procedure.

Code of Federal Regulations, 2014 CFR

2014-10-01

... rotate, while translating in the direction of the pendulum preimpact flight, in reference to the pendulum... displacement at time “T” is defined as the straight line distance between the position relative to the pendulum arm of the head's center of gravity at time “zero;” and the position relative to the pendulum arm of...

49 CFR 572.73 - Neck assembly and test procedure.

Code of Federal Regulations, 2012 CFR

2012-10-01

... rotate, while translating in the direction of the pendulum preimpact flight, in reference to the pendulum... displacement at time “T” is defined as the straight line distance between the position relative to the pendulum arm of the head's center of gravity at time “zero;” and the position relative to the pendulum arm of...

Enzalutamide in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer: Extended Analysis of the Phase 3 PREVAIL Study

PubMed Central

Beer, Tomasz M.; Armstrong, Andrew J.; Rathkopf, Dana; Loriot, Yohann; Sternberg, Cora N.; Higano, Celestia S.; Iversen, Peter; Evans, Christopher P.; Kim, Choung-Soo; Kimura, Go; Miller, Kurt; Saad, Fred; Bjartell, Anders S.; Borre, Michael; Mulders, Peter; Tammela, Teuvo L.; Parli, Teresa; Sari, Suha; van Os, Steve; Theeuwes, Ad; Tombal, Bertrand

2017-01-01

Enzalutamide significantly improved radiographic progression-free survival (rPFS) and overall survival (OS) among men with chemotherapy-naïve metastatic castration-resistant prostate cancer at the prespecified interim analysis of PREVAIL, a phase 3, double-blind, randomized study. We evaluated the longer-term efficacy and safety of enzalutamide up to the prespecified number of deaths in the final analysis, which included an additional 20 mo of follow-up for investigator-assessed rPFS, 9 mo of follow-up for OS, and 4 mo of follow-up for safety. Enzalutamide reduced the risk of radiographic progression or death by 68% (hazard ratio [HR] 0.32, 95% confidence interval [CI] 0.28–0.37; p < 0.0001) and the risk of death by 23% (HR 0.77, 95% CI 0.67–0.88; p = 0.0002). Median investigator-assessed rPFS was 20.0 mo (95% CI 18.9–22.1) in the enzalutamide arm and 5.4 mo (95% CI 4.1–5.6) in the placebo arm. Median OS was 35.3 mo (95% CI 32.2–not yet reached) in the enzalutamide arm and 31.3 mo (95% CI 28.8–34.2) in the placebo arm. At the time of the OS analysis, 167 patients in the placebo arm had crossed over to receive enzalutamide. The most common adverse events in the enzalutamide arm were fatigue, back pain, constipation, and arthralgia. This final analysis of PREVAIL provides more complete assessment of the clinical benefit of enzalutamide. PMID:27477525

Metformin and/or clomiphene do not adversely affect liver or renal function in women with polycystic ovary syndrome.

PubMed

Aubuchon, Mira; Kunselman, Allen R; Schlaff, William D; Diamond, Michael P; Coutifaris, Christos; Carson, Sandra A; Steinkampf, Michael P; Carr, Bruce R; McGovern, Peter G; Cataldo, Nicholas A; Gosman, Gabriella G; Nestler, John E; Myers, Evan R; Legro, Richard S

2011-10-01

Nonalcoholic fatty liver disease is common to insulin-resistant states such as polycystic ovary syndrome (PCOS). Metformin (MET) is often used to treat PCOS but information is limited as to its effects on liver function. We sought to determine the effects of MET on serum hepatic parameters in PCOS patients. This was a secondary analysis of a randomized, doubled-blind trial from 2002-2004. This multi-center clinical trial was conducted in academic centers. Six hundred twenty-six infertile women with PCOS with serum liver function parameters less than twice the upper limit of normal were included. Clomiphene citrate (n = 209), MET (n = 208), or combined (n = 209) were given for up to 6 months. The percent change from baseline in renal and liver function between- and within-treatment arms was assessed. Renal function improved in all treatment arms with significant decreases in serum blood urea nitrogen levels (range, -14.7 to -21.3%) as well as creatinine (-4.2 to -6.9%). There were similar decreases in liver transaminase levels in the clomiphene citrate and combined arms (-10% in bilirubin, -9 to -11% in transaminases) without significant changes in the MET arm. When categorizing baseline bilirubin, aspartate aminotransferase, and alanine aminotransferase into tertiles, there were significant within-treatment arm differences between the tertiles with the highest tertile having the largest decrease from baseline regardless of treatment arm. Women with PCOS can safely use metformin and clomiphene even in the setting of mildly abnormal liver function parameters, and both result in improved renal function.

Training of reaching in stroke survivors with severe and chronic upper limb paresis using a novel nonrobotic device: a randomized clinical trial.

PubMed

Barker, Ruth N; Brauer, Sandra G; Carson, Richard G

2008-06-01

Severe upper limb paresis is a major contributor to disability after stroke. This study investigated the efficacy of a new nonrobotic training device, the Sensorimotor Active Rehabilitation Training (SMART) Arm, that was used with or without electromyography-triggered electrical stimulation of triceps brachii to augment elbow extension, permitting stroke survivors with severe paresis to practice a constrained reaching task. A single-blind, randomized clinical trial was conducted with 42 stroke survivors with severe and chronic paresis. Thirty-three participants completed the study, of whom 10 received training using the SMART Arm with electromyography-triggered electrical stimulation, 13 received training using the SMART Arm alone, and 10 received no intervention (control). Training consisted of 12 1-hour sessions over 4 weeks. The primary outcome measure was "upper arm function," item 6 of the Motor Assessment Scale. Secondary outcome measures included impairment measures; triceps muscle strength, reaching force, modified Ashworth scale; and activity measures: reaching distance and Motor Assessment Scale. Assessments were administered before (0 weeks) and after training (4 weeks) and at 2 months follow-up (12 weeks). Both SMART Arm groups demonstrated significant improvements in all impairment and activity measures after training and at follow-up. There was no significant difference between these 2 groups. There was no change in the control group. Our findings indicate that training of reaching using the SMART Arm can reduce impairment and improve activity in stroke survivors with severe and chronic upper limb paresis, highlighting the benefits of intensive task-oriented practice, even in the context of severe paresis.

Pituitary volume increase during emerging psychosis.

PubMed

Büschlen, Jeannine; Berger, Gregor E; Borgwardt, Stefan J; Aston, Jacqueline; Gschwandtner, Ute; Pflueger, Marlon O; Kuster, Pascal; Radü, Ernst Wilhem; Stieglitz, Rolf-Dieter; Riecher-Rössler, Anita

2011-01-01

Morphologic abnormalities of the pituitary gland volume (PV) have been reported in schizophrenia, but at what point in time they occur remains unclear. This study determines PV across different stages of emerging psychotic disorders compared to healthy controls. We compared PV of 36 individuals with an at-risk mental state (ARMS) for psychosis, 23 patients with a first episode psychosis (FEP) and 20 healthy controls (HC). Transition to psychosis was monitored using the BPRS transition criteria according to Yung et al. (Yung, A.R. et al., 1998. Prediction of psychosis. A step towards indicated prevention of schizophrenia. Br. J. Psychiatry Suppl. 172 (33), 14-20). Applying these transition criteria, 16 of the 36 ARMS individuals made the transition to psychosis (ARMS-T) and 20 did not (ARMS-NT). We traced PV manually on 1mm slices of magnetic resonance images in three dimensions (coronal, sagittal and axial) blind to group status. We used univariate analysis of covariance (ANCOVA) with PV as dependent variable, group and sex as between-subject factors and whole brain volume as covariate. PV increased from HC to ARMS-NT to ARMS-T/FEP. ANCOVA revealed a significant effect of group (F(3,78)=3.0; p=.036) and a sex × group interaction (F(3,78)=6.5; p=.001). Over all groups, women had considerably larger PV than men (F(1,78)=9.8; p=.003). Our findings provide further evidence that PV is increased in emerging psychotic disorders, and suggest that this is due to a stress-associated activation of the pituitary gland. Copyright © 2010 Elsevier B.V. All rights reserved.

Integral equation theory study on the phase separation in star polymer nanocomposite melts.

PubMed

Zhao, Lei; Li, Yi-Gui; Zhong, Chongli

2007-10-21

The polymer reference interaction site model theory is used to investigate phase separation in star polymer nanocomposite melts. Two kinds of spinodal curves were obtained: classic fluid phase boundary for relatively low nanoparticle-monomer attraction strength and network phase boundary for relatively high nanoparticle-monomer attraction strength. The network phase boundaries are much more sensitive with nanoparticle-monomer attraction strength than the fluid phase boundaries. The interference among the arm number, arm length, and nanoparticle-monomer attraction strength was systematically investigated. When the arm lengths are short, the network phase boundary shows a marked shift toward less miscibility with increasing arm number. When the arm lengths are long enough, the network phase boundaries show opposite trends. There exists a crossover arm number value for star polymer nanocomposite melts, below which the network phase separation is consistent with that of chain polymer nanocomposite melts. However, the network phase separation shows qualitatively different behaviors when the arm number is larger than this value.

Perceptual, not memorial, disruption underlies emotion-induced blindness.

PubMed

Kennedy, Briana L; Most, Steven B

2012-04-01

Emotion-induced blindness refers to impaired awareness of stimuli appearing in the temporal wake of an emotionally arousing stimulus (S. B. Most, Chun, Widders, & Zald, 2005). In previous emotion-induced blindness experiments, participants withheld target responses until the end of a rapid stream of stimuli, even though each target appeared in the middle of the stream. The resulting interval between the targets' offset and participants' initiation of a response leaves open the possibility that emotion-induced blindness reflects a failure to encode or maintain target information in memory rather than a failure of perception. In the present study, participants engaged in a typical emotion-induced blindness task but initiated a response immediately upon seeing each target. Emotion-induced blindness was nevertheless robust. This suggests that emotion-induced blindness is not attributable to the delay between awareness of a target and the initiation of a response, but rather reflects the disruptive impact of emotional distractors on mechanisms driving conscious perception. (PsycINFO Database Record (c) 2012 APA, all rights reserved).

Validity and inter-observer reliability of subjective hand-arm vibration assessments.

PubMed

Coenen, Pieter; Formanoy, Margriet; Douwes, Marjolein; Bosch, Tim; de Kraker, Heleen

2014-07-01

Exposure to mechanical vibrations at work (e.g., due to handling powered tools) is a potential occupational risk as it may cause upper extremity complaints. However, reliable and valid assessment methods for vibration exposure at work are lacking. Measuring hand-arm vibration objectively is often difficult and expensive, while often used information provided by manufacturers lacks detail. Therefore, a subjective hand-arm vibration assessment method was tested on validity and inter-observer reliability. In an experimental protocol, sixteen tasks handling powered tools were executed by two workers. Hand-arm vibration was assessed subjectively by 16 observers according to the proposed subjective assessment method. As a gold standard reference, hand-arm vibration was measured objectively using a vibration measurement device. Weighted κ's were calculated to assess validity, intra-class-correlation coefficients (ICCs) were calculated to assess inter-observer reliability. Inter-observer reliability of the subjective assessments depicting the agreement among observers can be expressed by an ICC of 0.708 (0.511-0.873). The validity of the subjective assessments as compared to the gold-standard reference can be expressed by a weighted κ of 0.535 (0.285-0.785). Besides, the percentage of exact agreement of the subjective assessment compared to the objective measurement was relatively low (i.e., 52% of all tasks). This study shows that subjectively assessed hand-arm vibrations are fairly reliable among observers and moderately valid. This assessment method is a first attempt to use subjective risk assessments of hand-arm vibration. Although, this assessment method can benefit from some future improvement, it can be of use in future studies and in field-based ergonomic assessments. Copyright © 2014 Elsevier Ltd and The Ergonomics Society. All rights reserved.

Evaluation of the immunogenicity and safety of different doses and formulations of a broad spectrum influenza vaccine (FLU-v) developed by SEEK: study protocol for a single-center, randomized, double-blind and placebo-controlled clinical phase IIb trial.

PubMed

van Doorn, Eva; Pleguezuelos, Olga; Liu, Heng; Fernandez, Ana; Bannister, Robin; Stoloff, Gregory; Oftung, Fredrik; Norley, Stephen; Huckriede, Anke; Frijlink, Henderik W; Hak, Eelko

2017-04-04

Current influenza vaccines, based on antibodies against surface antigens, are unable to provide protection against newly emerging virus strains which differ from the vaccine strains. Therefore the population has to be re-vaccinated annually. It is thus important to develop vaccines which induce protective immunity to a broad spectrum of influenza viruses. This trial is designed to evaluate the immunogenicity and safety of FLU-v, a vaccine composed of four synthetic peptides with conserved epitopes from influenza A and B strains expected to elicit both cell mediated immunity (CMI) and humoral immunity providing protection against a broad spectrum of influenza viruses. In a single-center, randomized, double-blind and placebo-controlled phase IIb trial, 222 healthy volunteers aged 18-60 years will be randomized (2:2:1:1) to receive two injections of a suspension of 500 μg FLU-v in saline (arm 1), one dose of emulsified 500 μg FLU-v in Montanide ISA-51 and water for injection (WFI) followed by one saline dose (arm 2), two saline doses (arm 3), or one dose of Montanide ISA-51 and WFI emulsion followed by one saline dose (arm 4). All injections will be given subcutaneously. Primary endpoints are safety and FLU-v induced CMI, evaluated by cytokine production by antigen specific T cell populations (flow-cytometry and ELISA). Secondary outcomes are measurements of antibody responses (ELISA and multiplex), whereas exploratory outcomes include clinical efficacy and additional CMI assays (ELISpot) to show cross-reactivity. Broadly protective influenza vaccines able to provide protection against multiple strains of influenza are urgently needed. FLU-v is a promising vaccine which has shown to trigger the cell-mediated immune response. The dosages and formulations tested in this current trial are also estimated to induce antibody response. Therefore, both cellular and humoral immune responses will be evaluated. EudraCT number 2015-001932-38 ; retrospectively registered clinicaltrials.gov NCT02962908 (November 7th 2016).

Effectiveness of a one-year multi-component day-camp intervention for overweight children: study protocol of the Odense overweight intervention study (OOIS).

PubMed

Larsen, Kristian Traberg; Huang, Tao; Møller, Niels Christian; Andersen, Lars Bo; Ried-Larsen, Mathias

2014-04-05

Childhood overweight has noticeable psychological and social consequences for the child and leads to an increased risk of mortality and morbidity later in life. With the high prevalence of overweight in children and adolescents, it is important to identify effective approaches for the prevention and treatment of overweight in children and young individuals. The primary aim of the study is to assess the effect of an intensive day-camp intervention on body mass index (BMI) in overweight children. The Odense Overweight Intervention Study is a semi-blinded randomized controlled trial. Overweight children from the Municipality of Odense, Denmark, were invited to participate in the trial. Based on power calculations 98 participants were found to be sufficient to randomize in order to find an effect of minimum 1.5 BMI points. Gender-stratified concealed block randomization with a ratio of 1:1 and random block sizes of two, four, and six ensured balance between study arms. The intervention consisted of a six-week multi-component day camp including increased physical activity, healthy diet and health education followed by 46 weeks of family-based habitual intervention. The standard care arm was offered two weekly hours of physical activity training for six weeks. The outcomes were measured at baseline and at six-week and 52-week follow-ups. Furthermore, BMI will be assessed again at 48-month follow-up. Test personnel were kept blinded. The intervention effect will be evaluated using mixed model analyses. During 2012 and 2013, 115 children were enrolled in the study. Fifty-nine children were randomized to the day-camp intervention arm and 56 to the standard intervention arm. This study will provide novel information about the long-term health effects of an intense day-camp intervention program on overweight children, due to the design and the follow-up period. Moreover, it will add to the knowledge on designing and implementing feasible camp settings for preventing overweight in children. NCT01574352 at http://clinicaltrials.gov on the 8th of March 2012.

Healthcare resource utilization with ixazomib or placebo plus lenalidomide-dexamethasone in the randomized, double-blind, phase 3 TOURMALINE-MM1 study in relapsed/refractory multiple myeloma.

PubMed

Hari, Parameswaran; Lin, Huamao Mark; Zhu, Yanyan; Berg, Deborah; Richardson, Paul G; Moreau, Philippe

2018-05-29

The aim of this analysis was to assess healthcare resource utilization in the pivotal phase 3 TOURMALINE-MM1 study of the oral proteasome inhibitor ixazomib or placebo plus lenalidomide and dexamethasone (Rd) in relapsed and/or refractory multiple myeloma (RRMM). In this double-blind, placebo-controlled, randomized study (NCT01564537), 722 patients with RRMM following 1-3 prior lines of therapy received Rd plus ixazomib (ixazomib-Rd; n = 360) or matching placebo (placebo-Rd; n = 362) until disease progression or unacceptable toxicity. Healthcare resource utilization data were captured on Day 1 of each 28-day cycle, every 4 weeks during follow-up for progression-free survival, and every 12 weeks during subsequent follow-up, and included medical encounters (length of stay, inpatient, outpatient, and reason) and number of missing days from work or other activities for patients and caregivers. Exposure-adjusted rates of hospitalization were similar between the ixazomib-Rd and placebo-Rd arms, at 0.530 and 0.564 per patient year (ppy), respectively, as were outpatient visit rates (3.305 and 3.355 ppy). Mean length of hospitalization per patient was 10.0 and 10.8 days, respectively. In both arms, hospitalization and outpatient visit rates were higher in patients with two or three prior lines of treatment (ixazomib-Rd: 0.632 and 3.909 ppy; placebo-Rd: 0.774 and 3.539 ppy) compared with patients with one prior line (ixazomib-Rd: 0.460 and 2.888 ppy; placebo-Rd: 0.436 and 3.243 ppy). Patients and their caregivers who missed any work or other activity missed a median of 7 and 5 days in the ixazomib-Rd arm, respectively, vs 8 and 4 days with placebo-Rd. The study was not powered for a statistical comparison of healthcare resource utilization between treatment arms, nor did it capture costs associated with utilization of the identified healthcare resources. This pre-specified analysis demonstrated that the all-oral triplet regimen of ixazomib added to Rd did not increase healthcare resource utilization compared with placebo-Rd.

20 CFR 416.1720 - Whom we refer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Treatment of Alcoholism Or Drug Addiction § 416.1720 Whom we refer. We will refer you to an approved facility for treatment of your alcoholism or drug addiction if— (a) You are disabled; (b) You are not blind; (c) You are not 65 years old or older; and (d) Alcoholism or drug addiction is a contributing factor...

20 CFR 416.1720 - Whom we refer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Treatment of Alcoholism Or Drug Addiction § 416.1720 Whom we refer. We will refer you to an approved facility for treatment of your alcoholism or drug addiction if— (a) You are disabled; (b) You are not blind; (c) You are not 65 years old or older; and (d) Alcoholism or drug addiction is a contributing factor...

20 CFR 416.1720 - Whom we refer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Treatment of Alcoholism Or Drug Addiction § 416.1720 Whom we refer. We will refer you to an approved facility for treatment of your alcoholism or drug addiction if— (a) You are disabled; (b) You are not blind; (c) You are not 65 years old or older; and (d) Alcoholism or drug addiction is a contributing factor...

20 CFR 416.1720 - Whom we refer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Treatment of Alcoholism Or Drug Addiction § 416.1720 Whom we refer. We will refer you to an approved facility for treatment of your alcoholism or drug addiction if— (a) You are disabled; (b) You are not blind; (c) You are not 65 years old or older; and (d) Alcoholism or drug addiction is a contributing factor...

A wide angle low coherence interferometry based eye length optometer

NASA Astrophysics Data System (ADS)

Meadway, Alexander; Siegwart, John; Wildsoet, Christine; Norton, Thomas; Zhang, Yuhua

2015-03-01

Interest in eye growth regulation has burgeoned with the rise in myopia prevalence world-wide. Eye length and eye shape are fundamental metrics for related research, but current in vivo measurement techniques are generally limited to the optical axis of the eye. We describe a high resolution, time domain low coherence interferometry based optometer for measuring the eye length of small animals over a wide field of view. The system is based upon a Michelson interferometer using a superluminescent diode as a source, including a sample arm and a reference arm. The sample arm is split into two paths by a polarisation beam splitter; one focuses the light on the cornea and the other focuses the light on the retina. This method has a high efficiency of detection for reflections from both surfaces. The reference arm contains a custom high speed linear motor with 25 mm stroke and equipped with a precision displacement encoder. Light reflected from the cornea and the retina is combined with the reference beam to generate low coherence interferograms. Two galvo scanners are employed to steer the light to different angles so that the eye length over a field of view of 20° × 20° can be measured. The system has an axial resolution of 6.8 μm (in air) and the motor provides accurate movement, allowing for precise and repeatable measurement of coherence peak positions. Example scans from a tree shrew are presented.

An Adaptation-Induced Repulsion Illusion in Tactile Spatial Perception

PubMed Central

Li, Lux; Chan, Arielle; Iqbal, Shah M.; Goldreich, Daniel

2017-01-01

Following focal sensory adaptation, the perceived separation between visual stimuli that straddle the adapted region is often exaggerated. For instance, in the tilt aftereffect illusion, adaptation to tilted lines causes subsequently viewed lines with nearby orientations to be perceptually repelled from the adapted orientation. Repulsion illusions in the nonvisual senses have been less studied. Here, we investigated whether adaptation induces a repulsion illusion in tactile spatial perception. In a two-interval forced-choice task, participants compared the perceived separation between two point-stimuli applied on the forearms successively. Separation distance was constant on one arm (the reference) and varied on the other arm (the comparison). In Experiment 1, we took three consecutive baseline measurements, verifying that in the absence of manipulation, participants’ distance perception was unbiased across arms and stable across experimental blocks. In Experiment 2, we vibrated a region of skin on the reference arm, verifying that this focally reduced tactile sensitivity, as indicated by elevated monofilament detection thresholds. In Experiment 3, we applied vibration between the two reference points in our distance perception protocol and discovered that this caused an illusory increase in the separation between the points. We conclude that focal adaptation induces a repulsion aftereffect illusion in tactile spatial perception. The illusion provides clues as to how the tactile system represents spatial information. The analogous repulsion aftereffects caused by adaptation in different stimulus domains and sensory systems may point to fundamentally similar strategies for dynamic sensory coding. PMID:28701936

Work ability in vibration-exposed workers.

PubMed

Gerhardsson, L; Hagberg, M

2014-12-01

Hand-arm vibration exposure may cause hand-arm vibration syndrome (HAVS) including sensorineural disturbances. To investigate which factors had the strongest impact on work ability in vibration-exposed workers. A cross-sectional study in which vibration-exposed workers referred to a department of occupational and environmental medicine were compared with a randomized sample of unexposed subjects from the general population of the city of Gothenburg. All participants underwent a structured interview, answered several questionnaires and had a physical examination including measurements of hand and finger muscle strength and vibrotactile and thermal perception thresholds. The vibration-exposed group (47 subjects) showed significantly reduced sensitivity to cold and warmth in digit 2 bilaterally (P < 0.01) and in digit 5 in the left hand (P < 0.05) and to warmth in digit 5 in the right hand (P < 0.01), compared with the 18 referents. Similarly, tactilometry showed significantly raised vibration perception thresholds among the workers (P < 0.05). A strong relationship was found for the following multiple regression model: estimated work ability = 11.4 - 0.1 × age - 2.3 × current stress level - 2.5 × current pain in hands/arms (multiple r = 0.68; P < 0.001). Vibration-exposed workers showed raised vibrotactile and thermal perception thresholds, compared with unexposed referents. Multiple regression analysis indicated that stress disorders and muscle pain in hands/arms must also be considered when evaluating work ability among subjects with HAVS. © The Author 2014. Published by Oxford University Press on behalf of the Society of Occupational Medicine.

Bacteriophages for treating urinary tract infections in patients undergoing transurethral resection of the prostate: a randomized, placebo-controlled, double-blind clinical trial.

PubMed

Leitner, Lorenz; Sybesma, Wilbert; Chanishvili, Nina; Goderdzishvili, Marina; Chkhotua, Archil; Ujmajuridze, Aleksandre; Schneider, Marc P; Sartori, Andrea; Mehnert, Ulrich; Bachmann, Lucas M; Kessler, Thomas M

2017-09-26

Urinary tract infections (UTI) are among the most prevalent microbial diseases and their financial burden on society is substantial. The continuing increase of antibiotic resistance worldwide is alarming. Thus, well-tolerated, highly effective therapeutic alternatives are urgently needed. Although there is evidence indicating that bacteriophage therapy may be effective and safe for treating UTIs, the number of investigated patients is low and there is a lack of randomized controlled trials. This study is the first randomized, placebo-controlled, double-blind trial investigating bacteriophages in UTI treatment. Patients planned for transurethral resection of the prostate are screened for UTIs and enrolled if in urine culture eligible microorganisms ≥10 4 colony forming units/mL are found. Patients are randomized in a double-blind fashion to the 3 study treatment arms in a 1:1:1 ratio to receive either: a) bacteriophage (i.e. commercially available Pyo bacteriophage) solution, b) placebo solution, or c) antibiotic treatment according to the antibiotic sensitivity pattern. All treatments are intended for 7 days. No antibiotic prophylaxes will be given to the double-blinded treatment arms a) and b). As common practice, the Pyo bacteriophage cocktail is subjected to periodic adaptation cycles during the study. Urinalysis, urine culture, bladder and pain diary, and IPSS questionnaire will be completed prior to and at the end of treatment (i.e. after 7 days) or at withdrawal/drop out from the study. Patients with persistent UTIs will undergo antibiotic treatment according to antibiotic sensitivity pattern. Based on the high lytic activity and the potential of resistance optimization by direct adaptation of bacteriophages, and considering the continuing increase of antibiotic resistance worldwide, bacteriophage therapy is a very promising treatment option for UTIs. Thus, our randomized controlled trial investigating bacteriophages for treating UTIs will provide essential insights into this potentially revolutionizing treatment option. This study has been registered at clinicaltrials.gov ( www.clinicaltrials.gov/ct2/show/NCT03140085 ). April 27, 2017.

Reference values of anthropometric measurements in Dutch children. The Oosterwolde Study.

PubMed

Gerver, W J; Drayer, N M; Schaafsma, W

1989-03-01

In the period 1979-1980 the following anthropometric measurements were recorded in 2351 healthy Dutch children from 0-17 years of age: height, weight, sitting height, arm span, lengths of upper-arm, lower-arm and hand, tibial length, foot length, biacromial diameter, biiliacal diameter, and head circumference. Corresponding percentile values were constructed on the basis of normality assumptions, the mean and standard deviation at age t being determined by a cubic spline approximation. The results are compared with other studies and given in the form of growth charts.

Lead accumulation in woodchucks (Marmota monax) at small arms and skeet ranges.

PubMed

Johnson, Mark S; Major, Michael A; Casteel, Stan W

2004-10-01

Increasing concern regarding the stewardship of US Army lands requires a proactive program to evaluate sites of potential risk. Small arms and upland skeet ranges are a potentially significant source of lead exposure for burrowing mammals. Woodchucks (Marmota monax) were evaluated for lead exposure in a previously used upland skeet range and a small arms range, respective to animals collected at two nearby reference locations. Soil lead concentrations collected at burrow entrances on the firing ranges were compared with blood, bone, kidney, liver, and fecal concentrations of woodchucks collected from the reference areas. No statistical differences were found in the lead concentrations in tissue between woodchucks in reference and firing ranges; concentrations of lead in liver and kidney were below detection limits. Levels in bone, blood, and feces suggest the bioavailability of lead at these various sites, although other factors (e.g., differences in foraging areas, age structure, habitat preferences, and environmental conditions) were also likely to influence exposure. Blood levels were below that which suggests toxicity. Further analysis of other ranges with higher lead concentrations and of small mammal species with smaller home ranges is recommended to further elucidate trends that could be extrapolated to other sites.

Accuracy of a Fourth-Generation Subcutaneous Continuous Glucose Sensor

PubMed Central

Garg, Satish K.; Brazg, Ronald; Bode, Bruce W.; Bailey, Timothy S.; Slover, Robert H.; Sullivan, Ashley; Huang, Suiying; Shin, John; Lee, Scott W.; Kaufman, Francine R.

2017-01-01

Abstract Background: This study evaluated the accuracy and performance of a fourth-generation subcutaneous glucose sensor (Guardian™ Sensor 3) in the abdomen and arm. Methods: Eighty-eight subjects (14–75 years of age, mean ± standard deviation [SD] of 42.0 ± 19.1 years) with type 1 or type 2 diabetes participated in the study. Subjects wore two sensors in the abdomen that were paired with either a MiniMed™ 640G insulin pump, or an iPhone® or iPod® touch® running a glucose monitoring mobile application (Guardian Connect system) and a third sensor in the arm, which was connected to a glucose sensor recorder (GSR). Subjects were also asked to undergo in-clinic visits of 12–14 h on study days 1, 3, and 7 for frequent blood glucose sample testing using a Yellow Springs Instrument (YSI) reference. Results: The overall mean absolute relative difference (MARD ± SD) between abdomen sensor glucose (SG) and YSI reference values was 9.6% ± 9.0% and 9.4% ± 9.8% for the MiniMed 640G insulin pump and Guardian Connect system, respectively; and 8.7% ± 8.0% between arm SG and YSI reference values. The percentage of SG values within 20% agreement of the YSI reference value (for YSI >80 mg/dL) was 90.7% with the MiniMed 640G insulin pump, 91.8% with the Guardian Connect system, and 93.1% for GSR-connected arm sensors. Mean functional sensor life, when calibrating 3–4 times/day, was 145.9 ± 39.3 h for sensors paired with the MiniMed 640G insulin pump, 146.1 ± 41.6 h for sensors paired with the Guardian Connect system, and 147.6 ± 40.4 h for sensors connected to the GSR. Responses to survey questions regarding sensor comfort and ease of use were favorable. Conclusions: The Guardian Sensor 3 glucose sensor, whether located in abdomen or the arm, provided accurate glucose readings when compared with the YSI reference and demonstrated functional life commensurate with the intended 7-day use. ClinicalTrials.gov: NCT02246582 PMID:28700272

Accuracy of a Fourth-Generation Subcutaneous Continuous Glucose Sensor.

PubMed

Christiansen, Mark P; Garg, Satish K; Brazg, Ronald; Bode, Bruce W; Bailey, Timothy S; Slover, Robert H; Sullivan, Ashley; Huang, Suiying; Shin, John; Lee, Scott W; Kaufman, Francine R

2017-08-01

This study evaluated the accuracy and performance of a fourth-generation subcutaneous glucose sensor (Guardian ™ Sensor 3) in the abdomen and arm. Eighty-eight subjects (14-75 years of age, mean ± standard deviation [SD] of 42.0 ± 19.1 years) with type 1 or type 2 diabetes participated in the study. Subjects wore two sensors in the abdomen that were paired with either a MiniMed ™ 640G insulin pump, or an iPhone ® or iPod ® touch ® running a glucose monitoring mobile application (Guardian Connect system) and a third sensor in the arm, which was connected to a glucose sensor recorder (GSR). Subjects were also asked to undergo in-clinic visits of 12-14 h on study days 1, 3, and 7 for frequent blood glucose sample testing using a Yellow Springs Instrument (YSI) reference. The overall mean absolute relative difference (MARD ± SD) between abdomen sensor glucose (SG) and YSI reference values was 9.6% ± 9.0% and 9.4% ± 9.8% for the MiniMed 640G insulin pump and Guardian Connect system, respectively; and 8.7% ± 8.0% between arm SG and YSI reference values. The percentage of SG values within 20% agreement of the YSI reference value (for YSI >80 mg/dL) was 90.7% with the MiniMed 640G insulin pump, 91.8% with the Guardian Connect system, and 93.1% for GSR-connected arm sensors. Mean functional sensor life, when calibrating 3-4 times/day, was 145.9 ± 39.3 h for sensors paired with the MiniMed 640G insulin pump, 146.1 ± 41.6 h for sensors paired with the Guardian Connect system, and 147.6 ± 40.4 h for sensors connected to the GSR. Responses to survey questions regarding sensor comfort and ease of use were favorable. The Guardian Sensor 3 glucose sensor, whether located in abdomen or the arm, provided accurate glucose readings when compared with the YSI reference and demonstrated functional life commensurate with the intended 7-day use. ClinicalTrials.gov : NCT02246582.

Bridging the gap between DeafBlind minds: interactional and social foundations of intention attribution in the Seattle DeafBlind community

PubMed Central

Edwards, Terra

2015-01-01

This article is concerned with social and interactional processes that simplify pragmatic acts of intention attribution. The empirical focus is a series of interactions among DeafBlind people in Seattle, Washington, where pointing signs are used to individuate objects of reference in the immediate environment. Most members of this community are born deaf and slowly become blind. They come to Seattle using Visual American Sign Language, which has emerged and developed in a field organized around visual modes of access. As vision deteriorates, however, links between deictic signs (such as pointing) and the present, remembered, or imagined environment erode in idiosyncratic ways across the community of language-users, and as a result, it becomes increasingly difficult for participants to converge on objects of reference. In the past, DeafBlind people addressed this problem by relying on sighted interpreters. Under the influence of the recent “pro-tactile” movement, they have turned instead to one another to find new solutions to these referential problems. Drawing on analyses of 120 h of videorecorded interaction and language-use, detailed fieldnotes collected during 12 months of sustained anthropological fieldwork, and more than 15 years of involvement in this community in a range of capacities, I argue that DeafBlind people are generating new and reciprocal modes of access to their environment, and this process is aligning language with context in novel ways. I discuss two mechanisms that can account for this process: embedding in the social field and deictic integration. I argue that together, these social and interactional processes yield a deictic system set to retrieve a restricted range of values from the extra-linguistic context, thereby attenuating the cognitive demands of intention attribution and narrowing the gap between DeafBlind minds. PMID:26500576

Bayesian selective response-adaptive design using the historical control.

PubMed

Kim, Mi-Ok; Harun, Nusrat; Liu, Chunyan; Khoury, Jane C; Broderick, Joseph P

2018-06-13

High quality historical control data, if incorporated, may reduce sample size, trial cost, and duration. A too optimistic use of the data, however, may result in bias under prior-data conflict. Motivated by well-publicized two-arm comparative trials in stroke, we propose a Bayesian design that both adaptively incorporates historical control data and selectively adapt the treatment allocation ratios within an ongoing trial responsively to the relative treatment effects. The proposed design differs from existing designs that borrow from historical controls. As opposed to reducing the number of subjects assigned to the control arm blindly, this design does so adaptively to the relative treatment effects only if evaluation of cumulated current trial data combined with the historical control suggests the superiority of the intervention arm. We used the effective historical sample size approach to quantify borrowed information on the control arm and modified the treatment allocation rules of the doubly adaptive biased coin design to incorporate the quantity. The modified allocation rules were then implemented under the Bayesian framework with commensurate priors addressing prior-data conflict. Trials were also more frequently concluded earlier in line with the underlying truth, reducing trial cost, and duration and yielded parameter estimates with smaller standard errors. © 2018 The Authors. Statistics in Medicine Published by John Wiley & Sons, Ltd.

Bilateral coupling facilitates recovery of rhythmical movements from perturbation in healthy and post-stroke subjects.

PubMed

Ustinova, Ksenia I; Feldman, Anatol G; Levin, Mindy F

2013-06-01

The paretic arm of subjects with stroke has a decreased ability to quickly adapt to and recover from perturbations during rhythmical arm swinging. We investigated whether bilateral coupling in the synchronous motion of two arms may facilitate the restoration of rhythmical movement of the paretic arm in subjects with chronic hemiparesis due to stroke. While standing, stroke and age-matched healthy (control) subjects swung one or both arms synchronously at ~0.8 Hz from the shoulder joints. In randomly selected cycles, one arm was transiently arrested by an electromagnetic device when moving forward or backward. In the control group, bilateral swinging resumed faster than unilateral swinging regardless of which arm was perturbed. In the stroke group, this effect was observed only when the perturbation was applied to the paretic arm, suggesting that the motion of the non-paretic arm accelerated the recovery from perturbation of the paretic arm. In addition, bilateral swinging resumed after reduced anterior-posterior excursions of both arms in stroke subjects. Results confirm previous findings that bilateral swinging is normally guided by central changes in the referent configuration of the two arms that function as a single unit. As a consequence, both arms cooperate in recovery from perturbation of motion applied to one arm. Results also suggest that stroke-related brain damage alters the symmetry of bilateral interaction, resulting in deficits of inter-manual cooperative action. The involvement of the non-paretic arm could be beneficial for the recovery of swinging of both arms and may also facilitate movements of the paretic arm in certain tasks.

Assessing Pharmacy Students’ Ability to Accurately Measure Blood Pressure Using a Blood Pressure Simulator Arm

PubMed Central

Bryant, Ginelle A.; Haack, Sally L.; North, Andrew M.

2013-01-01

Objective. To compare student accuracy in measuring normal and high blood pressures using a simulator arm. Methods. In this prospective, single-blind, study involving third-year pharmacy students, simulator arms were programmed with prespecified normal and high blood pressures. Students measured preset normal and high diastolic and systolic blood pressure using a crossover design. Results. One hundred sixteen students completed both blood pressure measurements. There was a significant difference between the accuracy of high systolic blood pressure (HSBP) measurement and normal systolic blood pressure (NSBP) measurement (mean HSBP difference 8.4 ± 10.9 mmHg vs NSBP 3.6 ± 6.4 mmHg; p<0.001). However, there was no difference between the accuracy of high diastolic blood pressure (HDBP) measurement and normal diastolic blood pressure (NDBP) measurement (mean HDBP difference 6.8 ± 9.6 mmHg vs. mean NDBP difference 4.6 ± 4.5 mmHg; p=0.089). Conclusions. Pharmacy students may need additional instruction and experience with taking high blood pressure measurements to ensure they are able to accurately assess this important vital sign. PMID:23788809

Assessing pharmacy students' ability to accurately measure blood pressure using a blood pressure simulator arm.

PubMed

Bottenberg, Michelle M; Bryant, Ginelle A; Haack, Sally L; North, Andrew M

2013-06-12

To compare student accuracy in measuring normal and high blood pressures using a simulator arm. In this prospective, single-blind, study involving third-year pharmacy students, simulator arms were programmed with prespecified normal and high blood pressures. Students measured preset normal and high diastolic and systolic blood pressure using a crossover design. One hundred sixteen students completed both blood pressure measurements. There was a significant difference between the accuracy of high systolic blood pressure (HSBP) measurement and normal systolic blood pressure (NSBP) measurement (mean HSBP difference 8.4 ± 10.9 mmHg vs NSBP 3.6 ± 6.4 mmHg; p<0.001). However, there was no difference between the accuracy of high diastolic blood pressure (HDBP) measurement and normal diastolic blood pressure (NDBP) measurement (mean HDBP difference 6.8 ± 9.6 mmHg vs. mean NDBP difference 4.6 ± 4.5 mmHg; p=0.089). Pharmacy students may need additional instruction and experience with taking high blood pressure measurements to ensure they are able to accurately assess this important vital sign.

Dynamic deformation inspection of a human arm by using a line-scan imaging system

NASA Astrophysics Data System (ADS)

Hu, Eryi

2009-11-01

A line-scan imaging system is used in the dynamic deformation measurement of a human arm when the muscle is contracting and relaxing. The measurement principle is based on the projection grating profilometry, and the measuring system is consisted of a line-scan CCD camera, a projector, optical lens and a personal computer. The detected human arm is put upon a reference plane, and a sinusoidal grating is projected onto the object surface and reference plane at an incidence angle, respectively. The deformed fringe pattern in the same line of the dynamic detected arm is captured by the line-scan CCD camera with free trigger model, and the deformed fringe pattern is recorded in the personal computer for processing. A fast Fourier transform combining with a filtering and spectrum shifting method is used to extract the phase information caused by the profile of the detected object. Thus, the object surface profile can be obtained following the geometric relationship between the fringe deformation and the object surface height. Furthermore, the deformation procedure can be obtained line by line. Some experimental results are presented to prove the feasibility of the inspection system.

Catch-up growth in children fed a macrobiotic diet in early childhood.

PubMed

Van Dusseldorp, M; Arts, I C; Bergsma, J S; De Jong, N; Dagnelie, P C; Van Staveren, W A

1996-12-01

To study the relationship between diet and growth, a longitudinal anthropometric study was conducted in a Dutch population consuming a macrobiotic diet. Measurements (anthropometry and food habit questionnaire) were taken in 1985 (0-7 y), 1987, and in 1993 (7-16 y, n = 209). Z-scores were calculated for anthropometric measures and changes expressed as the differences between 1993 and the mean of 1985 and 1987. Analysis indicated significant (P < 0.002) catch-up in height [(mean Z-score +/-sEM) +0.59 +/- 0.071 and arm circumference (+0.34 +/- 0.09) for age (boys and girls combined). In 1993, both girls and boys were still significantly (P < 0.05) below the reference for height and sum of four skinfolds for age, and girls were below reference for weight-for-height and arm circumference for age. In girls, multiple regression analyses showed a significant positive effect of the consumption frequency of dairy products on catch-up growth in height, weight and arm circumference, after adjustment for menarche, age, and baseline height, weight and arm circumference (P < 0.05). The addition of moderate amounts of dairy products to a vegan type of diet improved growth of children, especially girls.

The effect of vertical and horizontal symmetry on memory for tactile patterns in late blind individuals.

PubMed

Cattaneo, Zaira; Vecchi, Tomaso; Fantino, Micaela; Herbert, Andrew M; Merabet, Lotfi B

2013-02-01

Visual stimuli that exhibit vertical symmetry are easier to remember than stimuli symmetric along other axes, an advantage that extends to the haptic modality as well. Critically, the vertical symmetry memory advantage has not been found in early blind individuals, despite their overall superior memory, as compared with sighted individuals, and the presence of an overall advantage for identifying symmetric over asymmetric patterns. The absence of the vertical axis memory advantage in the early blind may depend on their total lack of visual experience or on the effect of prolonged visual deprivation. To disentangle this issue, in this study, we measured the ability of late blind individuals to remember tactile spatial patterns that were either vertically or horizontally symmetric or asymmetric. Late blind participants showed better memory performance for symmetric patterns. An additional advantage for the vertical axis of symmetry over the horizontal one was reported, but only for patterns presented in the frontal plane. In the horizontal plane, no difference was observed between vertical and horizontal symmetric patterns, due to the latter being recalled particularly well. These results are discussed in terms of the influence of the spatial reference frame adopted during exploration. Overall, our data suggest that prior visual experience is sufficient to drive the vertical symmetry memory advantage, at least when an external reference frame based on geocentric cues (i.e., gravity) is adopted.

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

PubMed

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

2014-10-01

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

A double-blind, randomized, multicenter phase 2 study of prasugrel versus placebo in adult patients with sickle cell disease

PubMed Central

2013-01-01

Background Platelet activation has been implicated in the pathogenesis of sickle cell disease (SCD) suggesting antiplatelet agents may be therapeutic. To evaluate the safety of prasugrel, a thienopyridine antiplatelet agent, in adult patients with SCD, we conducted a double-blind, randomized, placebo-controlled study. Methods The primary endpoint, safety, was measured by hemorrhagic events requiring medical intervention. Patients were randomized to prasugrel 5 mg daily (n = 41) or placebo (n = 21) for 30 days. Platelet function by VerifyNow® P2Y12 and vasodilator-stimulated phosphoprotein assays at days 10 and 30 were significantly inhibited in prasugrel- compared with placebo-treated SCD patients. Results There were no hemorrhagic events requiring medical intervention in either study arm. Mean pain rate (percentage of days with pain) and intensity in the prasugrel arm were decreased compared with placebo. However, these decreases did not reach statistical significance. Platelet surface P-selectin and plasma soluble P-selectin, biomarkers of in vivo platelet activation, were significantly reduced in SCD patients receiving prasugrel compared with placebo. In sum, prasugrel was well tolerated and not associated with serious hemorrhagic events. Conclusions Despite the small size and short duration of this study, there was a decrease in platelet activation biomarkers and a trend toward decreased pain. PMID:23414938

Effects of local microwave diathermy on shoulder pain and function in patients with rotator cuff tendinopathy in comparison to subacromial corticosteroid injections: a single-blind randomized trial.

PubMed

Rabini, Alessia; Piazzini, Diana B; Bertolini, Carlo; Deriu, Laura; Saccomanno, Maristella F; Santagada, Domenico A; Sgadari, Antonio; Bernabei, Roberto; Fabbriciani, Carlo; Marzetti, Emanuele; Milano, Giuseppe

2012-04-01

Single-blind randomized clinical trial, with a follow-up of 24 weeks. To determine the effects of hyperthermia via localized microwave diathermy on pain and disability in comparison to subacromial corticosteroid injections in patients with rotator cuff tendinopathy. Hyperthermia improves symptoms and function in several painful musculoskeletal disorders. However, the effects of microwave diathermy in rotator cuff tendinopathy have not yet been established. Ninety-two patients with rotator cuff tendinopathy and pain lasting for at least 3 months were recruited from the outpatient clinic of the Department of Orthopaedics and Traumatology, University Hospital, Rome, Italy. Participants were randomly allocated to either local microwave diathermy or subacromial corticosteroids. The primary outcome measure was the short form of the Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH). Secondary outcome measures were the Constant-Murley shoulder outcome score and a visual analog scale for pain assessment. At the end of treatment and at follow-up, both treatment groups experienced improvements in all outcome measures relative to baseline values. Changes over time in QuickDASH, Constant-Murley, and visual analog scale scores were not different between treatment arms. In patients with rotator cuff tendinopathy, the effects of localized microwave diathermy on disability, shoulder function, and pain are equivalent to those elicited by subacromial corticosteroid injections.

Randomized, double-blind, phase III trial of palonosetron versus granisetron in the triplet regimen for preventing chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy: TRIPLE study.

PubMed

Suzuki, K; Yamanaka, T; Hashimoto, H; Shimada, Y; Arata, K; Matsui, R; Goto, K; Takiguchi, T; Ohyanagi, F; Kogure, Y; Nogami, N; Nakao, M; Takeda, K; Azuma, K; Nagase, S; Hayashi, T; Fujiwara, K; Shimada, T; Seki, N; Yamamoto, N

2016-08-01

There has been no phase III study of comparing the efficacy of first- and second-generation 5-HT3 receptor antagonists in the triplet regimen with dexamethasone and aprepitant for preventing chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy (HEC). Patients with a malignant solid tumor who would receive HEC containing 50 mg/m(2) or more cisplatin were randomly assigned to either palonosetron (0.75 mg) arm (Arm P) or granisetron (1 mg) arm (Arm G), on day 1, both arms with dexamethasone (12 mg on day 1 and 8 mg on days 2-4) and aprepitant (125 mg on day 1 and 80 mg on days 2-3). The primary end point was complete response (CR; no vomiting/retching and no rescue medication) at the 0-120 h period and secondary end points included complete control (CC; no vomiting/retching, no rescue medication, and no more than mild nausea) and total control (TC; no vomiting/retching, no rescue medication, and no nausea). Between July 2011 and June 2012, 842 patients were enrolled. Of 827 evaluable, 272 of 414 patients (65.7%) in Arm P had a CR at the 0-120 h period when compared with 244 of 413 (59.1%) in Arm G (P = 0.0539). Both arms had the same CR rate of 91.8% at the acute (0-24 h) period, while at the delayed (24-120 h) period, Arm P had a significantly higher CR rate than Arm G (67.2% versus 59.1%; P = 0.0142). In secondary end points, Arm P had significantly higher rates than Arm G at the 0-120 h period (CC rate: 63.8% versus 55.9%, P = 0.0234; TC rate: 47.6% versus 40.7%, P = 0.0369) and delayed periods (CC rate: 65.2% versus 55.9%, P = 0.0053; TC rate: 48.6% versus 41.4%, P = 0.0369). The present study did not show the superiority of palonosetron when compared with granisetron in the triplet regimen regarding the primary end point. UMIN000004863. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Sublexical Processing in Visual Recognition of Chinese Characters: Evidence from Repetition Blindness for Subcharacter Components

ERIC Educational Resources Information Center

Yeh, Su-Ling; Li, Jing-Ling

2004-01-01

Repetition blindness (RB) refers to the failure to detect the second occurrence of a repeated item in rapid serial visual presentation (RSVP). In two experiments using RSVP, the ability to report two critical characters was found to be impaired when these two characters were identical (Experiment 1) or similar by sharing one repeated component…

34 CFR 367.32 - How does the Secretary reallot funds under section 752(j)(4) of the Act?

Code of Federal Regulations, 2013 CFR

2013-07-01

... States, as determined by the Secretary, whose population of older individuals who are blind has a... populations in other States of older individuals who are blind. (b) The amounts referred to in paragraph (a... year only. (Approved by the Office of Management and Budget under control number 1820-0018) (Authority...

34 CFR 367.32 - How does the Secretary reallot funds under section 752(j)(4) of the Act?

Code of Federal Regulations, 2014 CFR

2014-07-01

... States, as determined by the Secretary, whose population of older individuals who are blind has a... populations in other States of older individuals who are blind. (b) The amounts referred to in paragraph (a... year only. (Approved by the Office of Management and Budget under control number 1820-0018) (Authority...

Project Word-Back: Exploratory Follow-Up Study on Deaf-Blind (Rubella) Children in California.

ERIC Educational Resources Information Center

Scheffelin, Edward J.

Project Word-Back, an exploratory followup study of 21 young deaf-blind (Rubella) children (6 to 9 years old), was conducted to establish a tentative reference source of information, obtain teacher estimates on selected aspects of the current functioning level of a sample of children, and provide basic data from which hypotheses may be formulated…

Enhancing the Entertainment Experience of Blind and Low-Vision Theatregoers through Touch Tours

ERIC Educational Resources Information Center

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

2010-01-01

In this paper we demonstrate how universal design theory and the research available on museum-based touch tours can be used to develop a touch tour for blind and low-vision theatregoers. We discuss these theoretical and practical approaches with reference to data collected and experience gained from the creation and execution of a touch tour for…

A randomized phase 2 study comparing two doses of delafloxacin with tigecycline in adults with complicated skin and skin-structure infections.

PubMed

O'Riordan, William; Mehra, Purvi; Manos, Paul; Kingsley, Jeff; Lawrence, Laura; Cammarata, Sue

2015-01-01

A randomized, double-blind, multicenter trial was done to compare two doses of delafloxacin with tigecycline in patients with various complicated skin and skin-structure infections (wound infections following surgery, trauma, burns, or animal/insect bites, abscesses, and cellulitis). Patients were randomized 1:1:1 to receive delafloxacin 300mg intravenous (IV) every 12h, delafloxacin 450mg IV every 12h, or tigecycline 100mg IV×1, followed by 50mg IV every 12h; randomization was stratified by infection type. Duration of therapy was 5-14 days. The primary efficacy analysis, performed on the clinically evaluable (CE) population at the test-of-cure (TOC) visit (14-21 days after the final dose of study drug), compared clinical response rates in the delafloxacin and tigecycline arms. Clinical response rates in the two delafloxacin arms were also compared. Among CE patients, clinical cure rates at TOC visit were similar in the delafloxacin and tigecycline arms (94.3%, 92.5%, and 91.2%, respectively in delafloxacin 300-mg, delafloxacin 450-mg, and tigecycline arms). Overall, the most frequent adverse events were nausea, vomiting, and diarrhea; the 300-mg delafloxacin arm was the best-tolerated regimen. Delafloxacin was similarly effective as tigecycline for a variety of complicated skin and skin-structure infections and was well tolerated. (Clinicaltrials.gov NCT 0719810). Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

A new low-volume isosmotic polyethylene glycol solution plus bisacodyl versus split-dose 4 L polyethylene glycol for bowel cleansing prior to colonoscopy: a randomised controlled trial.

PubMed

Cesaro, Paola; Hassan, Cesare; Spada, Cristiano; Petruzziello, Lucio; Vitale, Giovanna; Costamagna, Guido

2013-01-01

4-L polyethylene glycol preparations are effective for colon cleansing before colonoscopy. However, large volume and unpleasant taste reduce tolerability and acceptability limiting patient compliance. A new isosmotic low-volume polyethylene glycol preparation with citrates and simethicone plus bisacodyl has been developed to improve patient compliance and tolerability. To compare the efficacy of 2 different regimens of preparation vs a split-dose of polyethylene glycol solution. In this randomised, blinded, comparative study, 153 patients were allocated to 3 arms. Arm 1 (n=52) received bisacodyl and 2-L polyethylene glycol with citrates and simethicone the day before the procedure. Arm 2 (n=50) received bisacodyl the day before and 2-L polyethylene glycol with citrates and simethicone on the day of colonoscopy. Control group (n=51) received a split-dose of 4-L polyethylene glycol. Cleansing was evaluated according to Ottawa scale. The mean Ottawa score was not different in the 3 groups. Excellent cleansing was observed more frequently in arm 2 (70%) than in controls (49%) (p<0.05). No serious adverse events were observed in the 3 regimens. The willingness to repeat the same bowel preparation was superior in arms 1 and 2 than in controls (p<0.001). New low-volume preparations seem to be as effective as the split 4-L polyethylene glycol regimen, showing a better tolerability and acceptability. Copyright © 2012. Published by Elsevier Ltd.

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.

105KE Basin Area Radiation Monitor System (ARMS) Acceptance Test Procedure

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

KINKEL, C.C.

1999-12-14

This procedure is intended for the Area Radiation Monitoring System, ARMS, that is replacing the existing Programmable Input-Output Processing System, PIOPS, radiation monitoring system in the 105KE basin. The new system will be referred to as the 105KE ARMS, 105KE Area Radiation Monitoring System. This ATP will ensure calibration integrity of the 105KE radiation detector loops. Also, this ATP will test and document the display, printing, alarm output, alarm acknowledgement, upscale check, and security functions. This ATP test is to be performed after completion of the 105KE ARMS installation. The alarm outputs of the 105KE ARMS will be connected tomore » the basin detector alarms, basin annunciator system, and security Alarm Monitoring System, AMS, located in the 200 area Central Alarm Station (CAS).« less

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

PubMed

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

2017-07-01

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

Definition of blindness under National Programme for Control of Blindness: Do we need to revise it?

PubMed Central

Vashist, Praveen; Senjam, Suraj Singh; Gupta, Vivek; Gupta, Noopur; Kumar, Atul

2017-01-01

A review appropriateness of the current definition of blindness under National Programme for Control of Blindness (NPCB), Government of India. Online search of peer-reviewed scientific published literature and guidelines using PubMed, the World Health Organization (WHO) IRIS, and Google Scholar with keywords, namely blindness and visual impairment, along with offline examination of reports of national and international organizations, as well as their cross-references was done until December 2016, to identify relevant documents on the definition of blindness. The evidence for the historical and currently adopted definition of blindness under the NPCB, the WHO, and other countries was reviewed. Differences in the NPCB and WHO definitions were analyzed to assess the impact on the epidemiological status of blindness and visual impairment in India. The differences in the criteria for blindness under the NPCB and the WHO definitions cause an overestimation of the prevalence of blindness in India. These variations are also associated with an over-representation of refractive errors as a cause of blindness and an under-representation of other causes under the NPCB definition. The targets for achieving elimination of blindness also become much more difficult to achieve under the NPCB definition. Ignoring differences in definitions when comparing the global and Indian prevalence of blindness will cause erroneous interpretations. We recommend that the appropriate modifications should be made in the NPCB definition of blindness to make it consistent with the WHO definition. PMID:28345562

Definition of blindness under National Programme for Control of Blindness: Do we need to revise it?

PubMed

Vashist, Praveen; Senjam, Suraj Singh; Gupta, Vivek; Gupta, Noopur; Kumar, Atul

2017-02-01

A review appropriateness of the current definition of blindness under National Programme for Control of Blindness (NPCB), Government of India. Online search of peer-reviewed scientific published literature and guidelines using PubMed, the World Health Organization (WHO) IRIS, and Google Scholar with keywords, namely blindness and visual impairment, along with offline examination of reports of national and international organizations, as well as their cross-references was done until December 2016, to identify relevant documents on the definition of blindness. The evidence for the historical and currently adopted definition of blindness under the NPCB, the WHO, and other countries was reviewed. Differences in the NPCB and WHO definitions were analyzed to assess the impact on the epidemiological status of blindness and visual impairment in India. The differences in the criteria for blindness under the NPCB and the WHO definitions cause an overestimation of the prevalence of blindness in India. These variations are also associated with an over-representation of refractive errors as a cause of blindness and an under-representation of other causes under the NPCB definition. The targets for achieving elimination of blindness also become much more difficult to achieve under the NPCB definition. Ignoring differences in definitions when comparing the global and Indian prevalence of blindness will cause erroneous interpretations. We recommend that the appropriate modifications should be made in the NPCB definition of blindness to make it consistent with the WHO definition.

The position of the arm during blood pressure measurement in sitting position.

PubMed

Adiyaman, Ahmet; Verhoeff, Rutger; Lenders, Jacques W M; Deinum, Jaap; Thien, Theo

2006-12-01

Determining the influence of the position of the arm on blood pressure measurement in the sitting position. Blood pressure of 128 individuals (the majority being treated hypertensive patients) visiting the outpatient clinic was measured simultaneously on both arms with arms in two different positions. First, both arms were placed at the chair support level and blood pressure was measured three times on both arms after 10 min of rest. Subsequently, while still remaining in the same sitting position, five blood pressure measurements were made simultaneously at both arms with one arm placed on the desk and one arm placed and supported at heart level (mid-sternal). The arm placed at heart level served as the reference arm. The choice of which arm was placed at desk level and which arm was placed at heart level was randomized. Both at desk level and at chair support level, mean (+/-SD) systolic and diastolic blood pressures were higher than blood pressure at heart level by 6.1/5.7+/-4.6/3.1 and 9.3/9.4+/-5.4/3.4 mmHg, respectively. The effect of the height differences between the arm positions on the blood pressure readings was smaller than predicted (0.49 mmHg/cm systolic and 0.47 mmHg/cm diastolic). No significant correlation was found between blood pressure difference in the different arm positions (desk and heart level) and age, sex, weight or baseline blood pressure. Different arm positions below heart level have significant effects on blood pressure readings. The leading guidelines about arm position during blood pressure measurement are not in accordance with the arm position used in the Framingham study, the most frequently used study for risk estimations.

Research on the measurement technology of effective arm length of swing arm profilometer

NASA Astrophysics Data System (ADS)

Chen, Lin; Jing, Hongwei; Wei, Zhongwei; Li, Jie; Cao, Xuedong

2014-09-01

When the swing arm profilometer(SAP) measuring the mirror, the effective arm length of SAP which haves an obvious influence on the measurement results of the mirror surface shape needs to be measured accurately. It requires the measurement uncertainty of the effective arm length to reach 10μm in order to meet the measurement requirements, in this paper, we present a kind of technology based on laser tracker to measure the effective arm length of SAP. When the swing arm rotates around the shaft axis of swing arm rotary stage, the probe and two laser tracker balls form three sections of circular arc around the shaft axis of swing arm rotary stage in space. Laser tracker tracks and measures the circular arcs of two laser tracker balls, the center coordinates of the circular plane of circular arc can be calculated by data processing. The linear equation that passes through the two center coordinates is the equation of the shaft axis of rotary stage, the vertical distance from the probe to the shaft axis of rotary stage which can be calculated refer to the equation from the point to the line is the effective arm length. After Matlab simulation, this measurement method can meet the measurement accuracy.

Effect of Telephone vs Video Interpretation on Parent Comprehension, Communication, and Utilization in the Pediatric Emergency Department: A Randomized Clinical Trial.

PubMed

Lion, K Casey; Brown, Julie C; Ebel, Beth E; Klein, Eileen J; Strelitz, Bonnie; Gutman, Colleen Kays; Hencz, Patty; Fernandez, Juan; Mangione-Smith, Rita

2015-12-01

Consistent professional interpretation improves communication with patients who have limited English proficiency. Remote modalities (telephone and video) have the potential for wide dissemination. To test the effect of telephone vs. video interpretation on communication during pediatric emergency care. Randomized trial of telephone vs. video interpretation at a free-standing, university-affiliated pediatric emergency department (ED). A convenience sample of 290 Spanish-speaking parents of pediatric ED patients with limited English proficiency were approached from February 24 through August 16, 2014, of whom 249 (85.9%) enrolled; of these, 208 (83.5%) completed the follow-up survey (91 parents in the telephone arm and 117 in the video arm). Groups did not differ significantly by consent or survey completion rate, ED factors (eg, ED crowding), child factors (eg, triage level, medical complexity), or parent factors (eg, birth country, income). Investigators were blinded to the interpretation modality during outcome ascertainment. Intention-to-treat data were analyzed August 25 to October 20, 2014. Telephone or video interpretation for the ED visit, randomized by day. Parents were surveyed 1 to 7 days after the ED visit to assess communication and interpretation quality, frequency of lapses in interpreter use, and ability to name the child's diagnosis. Two blinded reviewers compared parent-reported and medical record-abstracted diagnoses and classified parent-reported diagnoses as correct, incorrect, or vague. Among 208 parents who completed the survey, those in the video arm were more likely to name the child's diagnosis correctly than those in the telephone arm (85 of 114 [74.6%] vs. 52 of 87 [59.8%]; P = .03) and less likely to report frequent lapses in interpreter use (2 of 117 [1.7%] vs. 7 of 91 [7.7%]; P = .04). No differences were found between the video and telephone arms in parent-reported quality of communication (101 of 116 [87.1%] vs. 74 of 89 [83.1%]; P = .43) or interpretation (58 of 116 [50.0%] vs. 42 of 89 [47.2%]; P = .69). Video interpretation was more costly (per-patient mean [SD] cost, $61 [$36] vs. $31 [$20]; P < .001). Parent-reported adherence to the assigned modality was higher for the video arm (106 of 114 [93.0%] vs .68 of 86 [79.1%]; P = .004). Families with limited English proficiency who received video interpretation were more likely to correctly name the child's diagnosis and had fewer lapses in interpreter use. Use of video interpretation shows promise for improving communication and patient care in this population. clinicaltrials.gov Identifier: NCT01986179.

Lidar - DOE ARM StreamLine Doppler Lidar (Halo) - Raw Data

DOE Data Explorer

Newsom, Rob

2017-11-20

1. Evaluate performance of the Halo Photonics Streamline lidar against a calibrated reference (i.e. the BAO tower). 2. Provide measurements of vertical velocity for use with other scanning lidars to better constrain velocity retrievals. 3. Provide colocated reference for comparison with Vindicator lidars.

A simple integrated ratiometric wavelength monitor based on multimode interference structure

NASA Astrophysics Data System (ADS)

Hatta, Agus Muhamad; Farrell, Gerald; Wang, Qian

2008-09-01

Wavelength measurement or monitoring can be implemented using a ratiometric power measurement technique. A ratiometric wavelength monitor normally consists of a Y-branch splitter with two arms: an edge filter arm with a well defined spectral response and a reference arm or alternatively, two edge filters arms with opposite slope spectral responses. In this paper, a simple configuration for an integrated ratiometric wavelength monitor based on a single multimode interference structure is proposed. By optimizing the length of the MMI and the two output port positions, opposite spectral responses for the two output ports can be achieved. The designed structure demonstrates a spectral response suitable for wavelength measurement with potentially a 10 pm resolution over a 100 nm wavelength range.

Blindness and Severe Visual Impairment in Pupils at Schools for the Blind in Burundi

PubMed Central

Ruhagaze, Patrick; Njuguna, Kahaki Kimani Margaret; Kandeke, Lévi; Courtright, Paul

2013-01-01

Purpose: To determine the causes of childhood blindness and severe visual impairment in pupils attending schools for the blind in Burundi in order to assist planning for services in the country. Materials and Methods: All pupils attending three schools for the blind in Burundi were examined. A modified WHO/PBL eye examination record form for children with blindness and low vision was used to record the findings. Data was analyzed for those who became blind or severely visually impaired before the age of 16 years. Results: Overall, 117 pupils who became visually impaired before 16 years of age were examined. Of these, 109 (93.2%) were blind or severely visually impaired. The major anatomical cause of blindness or severe visual impairment was cornea pathology/phthisis (23.9%), followed by lens pathology (18.3%), uveal lesions (14.7%) and optic nerve lesions (11.9%). In the majority of pupils with blindness or severe visual impairment, the underlying etiology of visual loss was unknown (74.3%). More than half of the pupils with lens related blindness had not had surgery; among those who had surgery, outcomes were generally poor. Conclusion: The causes identified indicate the importance of continuing preventive public health strategies, as well as the development of specialist pediatric ophthalmic services in the management of childhood blindness in Burundi. The geographic distribution of pupils at the schools for the blind indicates a need for community-based programs to identify and refer children in need of services. PMID:23580854

Blindness and severe visual impairment in pupils at schools for the blind in Burundi.

PubMed

Ruhagaze, Patrick; Njuguna, Kahaki Kimani Margaret; Kandeke, Lévi; Courtright, Paul

2013-01-01

To determine the causes of childhood blindness and severe visual impairment in pupils attending schools for the blind in Burundi in order to assist planning for services in the country. All pupils attending three schools for the blind in Burundi were examined. A modified WHO/PBL eye examination record form for children with blindness and low vision was used to record the findings. Data was analyzed for those who became blind or severely visually impaired before the age of 16 years. Overall, 117 pupils who became visually impaired before 16 years of age were examined. Of these, 109 (93.2%) were blind or severely visually impaired. The major anatomical cause of blindness or severe visual impairment was cornea pathology/phthisis (23.9%), followed by lens pathology (18.3%), uveal lesions (14.7%) and optic nerve lesions (11.9%). In the majority of pupils with blindness or severe visual impairment, the underlying etiology of visual loss was unknown (74.3%). More than half of the pupils with lens related blindness had not had surgery; among those who had surgery, outcomes were generally poor. The causes identified indicate the importance of continuing preventive public health strategies, as well as the development of specialist pediatric ophthalmic services in the management of childhood blindness in Burundi. The geographic distribution of pupils at the schools for the blind indicates a need for community-based programs to identify and refer children in need of services.

A bill to require the Department of Defense to develop a plan to track and respond to incidents of hazing in the Armed Forces.

THOMAS, 112th Congress

Sen. Gillibrand, Kirsten E. [D-NY

2012-05-15

Senate - 05/15/2012 Read twice and referred to the Committee on Armed Services. (All Actions) Notes: For further action, see H.R.4310, which became Public Law 112-239 on 1/2/2013. Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Consequences for Russia's Arms Control Violations Act of 2014

THOMAS, 113th Congress

Rep. Rogers, Mike D. [R-AL-3

2014-07-30

House - 07/30/2014 Referred to the Committee on Foreign Affairs, and in addition to the Committees on Armed Services, and Oversight and Government Reform, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the... (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Research Review: Psychosocial Adjustment and Mental Health in Former Child Soldiers--A Systematic Review of the Literature and Recommendations for Future Research

ERIC Educational Resources Information Center

Betancourt, Theresa S.; Borisova, Ivelina; Williams, Timothy P.; Meyers-Ohki, Sarah E.; Rubin-Smith, Julia E.; Annan, Jeannie; Kohrt, Brandon A.

2013-01-01

Aims and scope: This article reviews the available quantitative research on psychosocial adjustment and mental health among children (age less than 18 years) associated with armed forces and armed groups (CAAFAG)--commonly referred to as child soldiers. Methods: PRISMA standards for systematic reviews were used to search PubMed, PsycInfo, JSTOR,…

Design and simulation of an articulated surgical arm for guiding stereotactic neurosurgery

NASA Astrophysics Data System (ADS)

Kadi, A. Majeed; Zamorano, Lucia J.; Frazer, Matthew P.; Lu, Yi

1992-03-01

In stereotactic surgery, the need exists for means of relating intraoperatively the position and orientation of the surgical instrument used by the neurosurgeon to a known frame of reference. An articulated arm is proposed which would provide the neurosurgeon with on-line information for position, and orientation of the surgical tools being moved by the neurosurgeon. The articulated arm has six degrees of freedom, with five revolute and one prismatic joints. The design features include no obstruction to the field of view, lightweight, good balance against gravity, an accuracy of 1 mm spherical error probability (SEP), and a solvable kinematic structure making it capable of fitting the operating room environment. The arm can be mounted on either the surgical table or the stereotactic frame. A graphical simulation of the arm was created using the IGRIP simulation package created by Deneb Robotics. The simulation demonstrates the use of the arm, mounted on several positions of the ring reaching various target points within the cranium.

Unilateral versus bilateral robot-assisted rehabilitation on arm-trunk control and functions post stroke: a randomized controlled trial.

PubMed

Wu, Ching-Yi; Yang, Chieh-Ling; Chen, Ming-de; Lin, Keh-Chung; Wu, Li-Ling

2013-04-12

Although the effects of robot-assisted arm training after stroke are promising, the relative effects of unilateral (URT) vs. bilateral (BRT) robot-assisted arm training remain uncertain. This study compared the effects of URT vs. BRT on upper extremity (UE) control, trunk compensation, and function in patients with chronic stroke. This was a single-blinded, randomized controlled trial. The intervention was implemented at 4 hospitals. Fifty-three patients with stroke were randomly assigned to URT, BRT, or control treatment (CT). Each group received UE training for 90 to 105 min/day, 5 days/week, for 4 weeks. The kinematic variables for arm motor control and trunk compensation included normalized movement time, normalized movement units, and the arm-trunk contribution slope in unilateral and bilateral tasks. Motor function and daily function were measured by the Wolf Motor Function Test (WMFT), Motor Activity Log (MAL), and ABILHAND Questionnaire. The BRT and CT groups elicited significantly larger slope values (i.e., less trunk compensation) at the start of bilateral reaching than the URT group. URT led to significantly better effects on WMFT-Time than BRT. Differences in arm control kinematics and performance on the MAL and ABILHAND among the 3 groups were not significant. BRT and URT resulted in differential improvements in specific UE/trunk performance in patients with stroke. BRT elicited larger benefits than URT on reducing compensatory trunk movements at the beginning of reaching. In contrast, URT produced better improvements in UE temporal efficiency. These relative effects on movement kinematics, however, did not translate into differential benefits in daily functions. ClinicalTrials.gov: NCT00917605.

Adding a PECS II block for proximal arm arteriovenous access - a randomised study.

PubMed

Quek, K H; Low, E Y; Tan, Y R; Ong, A S C; Tang, T Y; Kam, J W; Kiew, A S C

2018-05-01

Brachial plexus block is often utilised for proximal arm arteriovenous access creation. However, the medial upper arm and axilla are often inadequately anaesthetised, requiring repeated, intraoperative local anaesthetic supplementation, or conversion into general anaesthesia. We hypothesised that the addition of a PECS II block would improve anaesthesia and analgesia for proximal arm arteriovenous access surgery. In this prospective, double-blinded, randomised proof-of-concept study, 36 consenting adults with end-stage renal disease aged between 21 and 90 years received either a combined supraclavicular and PECS II block (Group PECS, n = 18), or combined supraclavicular and sham block (Group SCB, n = 18) for proximal arm arteriovenous access surgery. Primary outcome was whether patients required intraoperative local anaesthetic supplementation by the surgeon. In Group PECS, 33.3% (6/18) needed local anaesthetic supplementation vs. 100% (18/18) in Group SCB. Group SCB had three times (RR 3.0, 95% CI 1.6-5.8; P < 0.001) the risk of requiring intraoperative local anaesthetic supplementation. Group PECS required lower volume of supplemental local anaesthetic compared to Group SCB (0.0 ml, IQR 0.0-6.3 ml vs. 15.0 ml, IQR 7.4-17.8 ml; P < 0.001). Group SCB had twice [RR 2.2, 95% CI 1.1-4.4; (P = 0.019)] the risk of needing additional sedation or analgesia. There were no significant differences between the groups with respect to postoperative visual analogue scale pain scores, time to first rescue analgesia or patient satisfaction. The results suggest that adding a PECS II block to a supraclavicular block improves regional anaesthesia for patients with end-stage renal disease undergoing proximal arm arteriovenous access surgery. © 2018 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

Metformin and/or Clomiphene Do Not Adversely Affect Liver or Renal Function in Women with Polycystic Ovary Syndrome

PubMed Central

Aubuchon, Mira; Kunselman, Allen R.; Schlaff, William D.; Diamond, Michael P.; Coutifaris, Christos; Carson, Sandra A.; Steinkampf, Michael P.; Carr, Bruce R.; McGovern, Peter G.; Cataldo, Nicholas A.; Gosman, Gabriella G.; Nestler, John E.; Myers, Evan R.

2011-01-01

Context: Nonalcoholic fatty liver disease is common to insulin-resistant states such as polycystic ovary syndrome (PCOS). Metformin (MET) is often used to treat PCOS but information is limited as to its effects on liver function. Objective: We sought to determine the effects of MET on serum hepatic parameters in PCOS patients. Design: This was a secondary analysis of a randomized, doubled-blind trial from 2002–2004. Setting: This multi-center clinical trial was conducted in academic centers. Patients: Six hundred twenty-six infertile women with PCOS with serum liver function parameters less than twice the upper limit of normal were included. Interventions: Clomiphene citrate (n = 209), MET (n = 208), or combined (n = 209) were given for up to 6 months. Main Outcome Measure: The percent change from baseline in renal and liver function between- and within-treatment arms was assessed. Results: Renal function improved in all treatment arms with significant decreases in serum blood urea nitrogen levels (range, −14.7 to −21.3%) as well as creatinine (−4.2 to −6.9%). There were similar decreases in liver transaminase levels in the clomiphene citrate and combined arms (−10% in bilirubin, −9 to −11% in transaminases) without significant changes in the MET arm. When categorizing baseline bilirubin, aspartate aminotransferase, and alanine aminotransferase into tertiles, there were significant within-treatment arm differences between the tertiles with the highest tertile having the largest decrease from baseline regardless of treatment arm. Conclusion: Women with PCOS can safely use metformin and clomiphene even in the setting of mildly abnormal liver function parameters, and both result in improved renal function. PMID:21832111

Memantine for the prevention of cognitive dysfunction in patients receiving whole-brain radiotherapy: a randomized, double-blind, placebo-controlled trial

PubMed Central

Brown, Paul D.; Pugh, Stephanie; Laack, Nadia N.; Wefel, Jeffrey S.; Khuntia, Deepak; Meyers, Christina; Choucair, Ali; Fox, Sherry; Suh, John H.; Roberge, David; Kavadi, Vivek; Bentzen, Soren M.; Mehta, Minesh P.; Watkins-Bruner, Deborah

2013-01-01

Background To determine the protective effects of memantine on cognitive function in patients receiving whole-brain radiotherapy (WBRT). Methods Adult patients with brain metastases received WBRT and were randomized to receive placebo or memantine (20 mg/d), within 3 days of initiating radiotherapy for 24 weeks. Serial standardized tests of cognitive function were performed. Results Of 554 patients who were accrued, 508 were eligible. Grade 3 or 4 toxicities and study compliance were similar in the 2 arms. There was less decline in delayed recall in the memantine arm at 24 weeks (P = .059), but the difference was not statistically significant, possibly because there were only 149 analyzable patients at 24 weeks, resulting in only 35% statistical power. The memantine arm had significantly longer time to cognitive decline (hazard ratio 0.78, 95% confidence interval 0.62–0.99, P = .01); the probability of cognitive function failure at 24 weeks was 53.8% in the memantine arm and 64.9% in the placebo arm. Superior results were seen in the memantine arm for executive function at 8 (P = .008) and 16 weeks (P = .0041) and for processing speed (P = .0137) and delayed recognition (P = .0149) at 24 weeks. Conclusions Memantine was well tolerated and had a toxicity profile very similar to placebo. Although there was less decline in the primary endpoint of delayed recall at 24 weeks, this lacked statistical significance possibly due to significant patient loss. Overall, patients treated with memantine had better cognitive function over time; specifically, memantine delayed time to cognitive decline and reduced the rate of decline in memory, executive function, and processing speed in patients receiving WBRT. RTOG 0614, ClinicalTrials.gov number CT00566852. PMID:23956241

Memantine for the prevention of cognitive dysfunction in patients receiving whole-brain radiotherapy: a randomized, double-blind, placebo-controlled trial.

PubMed

Brown, Paul D; Pugh, Stephanie; Laack, Nadia N; Wefel, Jeffrey S; Khuntia, Deepak; Meyers, Christina; Choucair, Ali; Fox, Sherry; Suh, John H; Roberge, David; Kavadi, Vivek; Bentzen, Soren M; Mehta, Minesh P; Watkins-Bruner, Deborah

2013-10-01

To determine the protective effects of memantine on cognitive function in patients receiving whole-brain radiotherapy (WBRT). Adult patients with brain metastases received WBRT and were randomized to receive placebo or memantine (20 mg/d), within 3 days of initiating radiotherapy for 24 weeks. Serial standardized tests of cognitive function were performed. Of 554 patients who were accrued, 508 were eligible. Grade 3 or 4 toxicities and study compliance were similar in the 2 arms. There was less decline in delayed recall in the memantine arm at 24 weeks (P = .059), but the difference was not statistically significant, possibly because there were only 149 analyzable patients at 24 weeks, resulting in only 35% statistical power. The memantine arm had significantly longer time to cognitive decline (hazard ratio 0.78, 95% confidence interval 0.62-0.99, P = .01); the probability of cognitive function failure at 24 weeks was 53.8% in the memantine arm and 64.9% in the placebo arm. Superior results were seen in the memantine arm for executive function at 8 (P = .008) and 16 weeks (P = .0041) and for processing speed (P = .0137) and delayed recognition (P = .0149) at 24 weeks. Memantine was well tolerated and had a toxicity profile very similar to placebo. Although there was less decline in the primary endpoint of delayed recall at 24 weeks, this lacked statistical significance possibly due to significant patient loss. Overall, patients treated with memantine had better cognitive function over time; specifically, memantine delayed time to cognitive decline and reduced the rate of decline in memory, executive function, and processing speed in patients receiving WBRT. RTOG 0614, ClinicalTrials.gov number CT00566852.

MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer.

PubMed

Goetz, Matthew P; Toi, Masakazu; Campone, Mario; Sohn, Joohyuk; Paluch-Shimon, Shani; Huober, Jens; Park, In Hae; Trédan, Olivier; Chen, Shin-Cheh; Manso, Luis; Freedman, Orit C; Garnica Jaliffe, Georgina; Forrester, Tammy; Frenzel, Martin; Barriga, Susana; Smith, Ian C; Bourayou, Nawel; Di Leo, Angelo

2017-11-10

Purpose Abemaciclib, a cyclin-dependent kinase 4 and 6 inhibitor, demonstrated efficacy as monotherapy and in combination with fulvestrant in women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with endocrine therapy. Methods MONARCH 3 is a double-blind, randomized phase III study of abemaciclib or placebo plus a nonsteroidal aromatase inhibitor in 493 postmenopausal women with HR-positive, HER2-negative advanced breast cancer who had no prior systemic therapy in the advanced setting. Patients received abemaciclib or placebo (150 mg twice daily continuous schedule) plus either 1 mg anastrozole or 2.5 mg letrozole, daily. The primary objective was investigator-assessed progression-free survival. Secondary objectives included response evaluation and safety. A planned interim analysis occurred after 189 events. Results Median progression-free survival was significantly prolonged in the abemaciclib arm (hazard ratio, 0.54; 95% CI, 0.41 to 0.72; P = .000021; median: not reached in the abemaciclib arm, 14.7 months in the placebo arm). In patients with measurable disease, the objective response rate was 59% in the abemaciclib arm and 44% in the placebo arm ( P = .004). In the abemaciclib arm, diarrhea was the most frequent adverse effect (81.3%) but was mainly grade 1 (44.6%). Comparing abemaciclib and placebo, the most frequent grade 3 or 4 adverse events were neutropenia (21.1% v 1.2%), diarrhea (9.5% v 1.2%), and leukopenia (7.6% v 0.6%). Conclusion Abemaciclib plus a nonsteroidal aromatase inhibitor was effective as initial therapy, significantly improving progression-free survival and objective response rate and demonstrating a tolerable safety profile in women with HR-positive, HER2-negative advanced breast cancer.

Randomized trial for superiority of high field strength intra-operative magnetic resonance imaging guided resection in pituitary surgery.

PubMed

Tandon, Vivek; Raheja, Amol; Suri, Ashish; Chandra, P Sarat; Kale, Shashank S; Kumar, Rajinder; Garg, Ajay; Kalaivani, Mani; Pandey, Ravindra M; Sharma, Bhawani S

2017-03-01

Till date there are no randomized trials to suggest the superiority of intra-operative magnetic resonance imaging (IOMRI) guided trans-sphenoidal pituitary resection over two dimensional fluoroscopic (2D-F) guided resections. We conducted this trial to establish the superiority of IOMRI in pituitary surgery. Primary objective was to compare extent of tumor resection between the two study arms. It was a prospective, randomized, outcome assessor and statistician blinded, two arm (A: IOMRI, n=25 and B: 2D-F, n=25), parallel group clinical trial. 4 patients from IOMRI group cross-over to 2D-F group and were consequently analyzed in latter group, based on modified intent to treat method. A total of 50 patients were enrolled till completion of trial (n=25 in each study arm). Demographic profile and baseline parameters were comparable among the two arms (p>0.05) except for higher number of endoscopic procedures and experienced neurosurgeons (>10years) in arm B (p=0.02, 0.002 respectively). Extent of resection was similar in both study arms (A, 94.9% vs B, 93.6%; p=0.78), despite adjusting for experience of operating surgeon and use of microscope/endoscope for surgical resection. We observed that use of IOMRI helped optimize the extent of resection in 5/20 patients (25%) for pituitary tumor resection in-group A. Present study failed to observe superiorty of IOMRI over conventional 2D-F guided resection in pituitary macroadenoma surgery. By use of this technology, younger surgeons could validate their results intra-operatively and hence could increase EOR without causing any increase in complications. Copyright © 2016 Elsevier Ltd. All rights reserved.

Effect of Transcranial Direct Current Stimulation on Severely Affected Arm-Hand Motor Function in Patients After an Acute Ischemic Stroke: A Pilot Randomized Control Trial.

PubMed

Rabadi, Meheroz H; Aston, Christopher E

2017-10-01

The aim of this article was to determine whether cathodal transcranial direct current stimulation (c-tDCS) to unaffected primary motor cortex (PMC) plus conventional occupational therapy (OT) improves functional motor recovery of the affected arm hand in patients after an acute ischemic stroke compared with sham transcranial direct current stimulation plus conventional OT. In this prospective, randomized, double-blinded, sham-controlled trial of 16 severe, acute ischemic stroke patients with severe arm-hand weakness were randomly assigned to either experimental (c-tDCS plus OT; n = 8) or control (sham transcranial direct current stimulation plus OT; n = 8) groups. All patients received a standard 3-hr in-patient rehabilitation therapy, plus an additional ten 30-min sessions of tDCS. During each session, 1 mA of cathodal stimulation to the unaffected PMC is performed followed by the patient's scheduled OT. The primary outcome measure was change in Action Research Arm Test (ARAT) total and subscores on discharge. Application of c-tDCS to unaffected PMC resulted in a clinically relevant 10-point improvement in the affected arm-hand function based on ARAT total score compared with a 2-point improvement in the control group. Application of 30-min of c-tDCS to the unaffected PMC showed a 10-point improvement in the ARAT score. This corresponds to a large effect size in improvement of affected arm-hand function in patients with severe, acute ischemic stroke. Although not statistically significant, this suggests that larger studies, enrolling at least 25 patients in each group, and with a longer follow-up are warranted.

Bobath Concept versus constraint-induced movement therapy to improve arm functional recovery in stroke patients: a randomized controlled trial.

PubMed

Huseyinsinoglu, Burcu Ersoz; Ozdincler, Arzu Razak; Krespi, Yakup

2012-08-01

To compare the effects of the Bobath Concept and constraint-induced movement therapy on arm functional recovery among stroke patients with a high level of function on the affected side. A single-blinded, randomized controlled trial. Outpatient physiotherapy department of a stroke unit. A total of 24 patients were randomized to constraint-induced movement therapy or Bobath Concept group. The Bobath Concept group was treated for 1 hour whereas the constraint-induced movement therapy group received training for 3 hours per day during 10 consecutive weekdays. Main measures were the Motor Activity Log-28, the Wolf Motor Function Test, the Motor Evaluation Scale for Arm in Stroke Patients and the Functional Independence Measure. The two groups were found to be homogeneous based on demographic variables and baseline measurements. Significant improvements were seen after treatment only in the 'Amount of use' and 'Quality of movement' subscales of the Motor Activity Log-28 in the constraint-induced movement therapy group over the the Bobath Concept group (P = 0.003; P = 0.01 respectively). There were no significant differences in Wolf Motor Function Test 'Functional ability' (P = 0.137) and 'Performance time' (P = 0.922), Motor Evaluation Scale for Arm in Stroke Patients (P = 0.947) and Functional Independence Measure scores (P = 0.259) between the two intervention groups. Constraint-induced movement therapy and the Bobath Concept have similar efficiencies in improving functional ability, speed and quality of movement in the paretic arm among stroke patients with a high level of function. Constraint-induced movement therapy seems to be slightly more efficient than the Bobath Concept in improving the amount and quality of affected arm use.

Arm Locking for the Laser Interferometer Space Antenna

NASA Technical Reports Server (NTRS)

Maghami, P. G.; Thorpe, J. I.; Livas, J.

2009-01-01

The Laser Interferometer Space Antenna (LISA) mission is a planned gravitational wave detector consisting of three spacecraft in heliocentric orbit. Laser interferometry is used to measure distance fluctuations between test masses aboard each spacecraft to the picometer level over a 5 million kilometer separation. Laser frequency fluctuations must be suppressed in order to meet the measurement requirements. Arm-locking, a technique that uses the constellation of spacecraft as a frequency reference, is a proposed method for stabilizing the laser frequency. We consider the problem of arm-locking using classical optimal control theory and find that our designs satisfy the LISA requirements.

Greek mythology: the eye, ophthalmology, eye disease, and blindness.

PubMed

Trompoukis, Constantinos; Kourkoutas, Dimitrios

2007-06-01

In distant eras, mythology was a form of expression used by many peoples. A study of the Greek myths reveals concealed medical knowledge, in many cases relating to the eye. An analysis was made of the ancient Greek texts for mythological references relating to an understanding of vision, visual abilities, the eye, its congenital and acquired abnormalities, blindness, and eye injuries and their treatment. The Homeric epics contain anatomical descriptions of the eyes and the orbits, and an elementary knowledge of physiology is also apparent. The concept of the visual field can be seen in the myth of Argos Panoptes. Many myths describe external eye disease ("knyzosis"), visual disorders (amaurosis), and cases of blinding that, depending on the story, are ascribed to various causes. In addition, ocular motility abnormalities, congenital anomalies (cyclopia), injuries, and special treatments, such as the "licking" method, are mentioned. The study of mythological references to the eye reveals reliable medical observations of the ancient Greeks, which are concealed within the myths.

Research Report: Employment among Working-Age Members of the Royal New Zealand Foundation for the Blind.

ERIC Educational Resources Information Center

La Grow, Steven J.

2003-01-01

A survey of 150 working-age members of the Royal New Zealand Foundation for the Blind found just over a third were in paid employment, of whom nearly half were employed for less than 31 hours per week and 20-40% were underemployed. Of those employed, most had experienced breaks in employment averaging 5 years. (Contains 3 references.) (DB)

eLISA Telescope In-field Pointing and Scattered Light Study

NASA Astrophysics Data System (ADS)

Livas, J.; Sankar, S.; West, G.; Seals, L.; Howard, J.; Fitzsimons, E.

2017-05-01

The orbital motion of the three spacecraft that make up the eLISA Observatory constellation causes long-arm line of sight variations of approximately ± one degree over the course of a year. The baseline solution is to package the telescope, the optical bench, and the gravitational reference sensor (GRS) into an optical assembly at each end of the measurement arm, and then to articulate the assembly. An optical phase reference is exchanged between the moving optical benches with a single mode optical fiber (“backlink” fiber). An alternative solution, referred to as in-field pointing, embeds a steering mirror into the optical design, fixing the optical benches and eliminating the backlink fiber, but requiring the additional complication of a two-stage optical design for the telescope. We examine the impact of an in-field pointing design on the scattered light performance.

Assessing noninferiority in a three-arm trial using the Bayesian approach.

PubMed

Ghosh, Pulak; Nathoo, Farouk; Gönen, Mithat; Tiwari, Ram C

2011-07-10

Non-inferiority trials, which aim to demonstrate that a test product is not worse than a competitor by more than a pre-specified small amount, are of great importance to the pharmaceutical community. As a result, methodology for designing and analyzing such trials is required, and developing new methods for such analysis is an important area of statistical research. The three-arm trial consists of a placebo, a reference and an experimental treatment, and simultaneously tests the superiority of the reference over the placebo along with comparing this reference to an experimental treatment. In this paper, we consider the analysis of non-inferiority trials using Bayesian methods which incorporate both parametric as well as semi-parametric models. The resulting testing approach is both flexible and robust. The benefit of the proposed Bayesian methods is assessed via simulation, based on a study examining home-based blood pressure interventions. Copyright © 2011 John Wiley & Sons, Ltd.

A novel dNTP-limited PCR and HRM assay to detect Williams-Beuren syndrome.

PubMed

Zhang, Lichen; Zhang, Xiaoqing; You, Guoling; Yu, Yongguo; Fu, Qihua

2018-06-01

Williams-Beuren syndrome (WBS) is caused by a microdeletion of chromosome arm 7q11.23. A rapid and inexpensive genotyping method to detect microdeletion on 7q11.23 needs to be developed for the diagnosis of WBS. This study describes the development of a new type of molecular diagnosis method to detect microdeletion on 7q11.23 based upon high-resolution melting (HRM). Four genes on 7q11.23 were selected as the target genes for the deletion genotyping. dNTP-limited duplex PCR was used to amplify the reference gene, CFTR, and one of the four genes respectively on 7q11.23. An HRM assay was performed on the PCR products, and the height ratio of the negative derivative peaks between the target gene and reference gene was employed to analyze the copy number variation of the target region. A new genotyping method for detecting 7q11.23 deletion was developed based upon dNTP-limited PCR and HRM, which cost only 96 min. Samples from 15 WBS patients and 12 healthy individuals were genotyped by this method in a blinded fashion, and the sensitivity and specificity was 100% (95% CI, 0.80-1, and 95% CI, 0.75-1, respectively) which was proved by CytoScan HD array. The HRM assay we developed is an rapid, inexpensive, and highly accurate method for genotyping 7q11.23 deletion. It is potentially useful in the clinical diagnosis of WBS. Copyright © 2018 Elsevier B.V. All rights reserved.

Treatment of Vitamin D Insufficiency in Children and Adolescents with Inflammatory Bowel Disease: A Randomized Clinical Trial Comparing Three Regimens

PubMed Central

Mitchell, Paul D.; Jiang, Hongyu; Kassiff, Sivan; Filip-Dhima, Rajna; DiFabio, Diane; Quinn, Nicolle; Lawton, Rachel C.; Varvaris, Mark; Van Straaten, Stephanie; Gordon, Catherine M.

2012-01-01

Context: Vitamin D insufficiency [serum 25-hydroxyvitamin D (25OHD) concentration less than 20 ng/ml] is prevalent among children with inflammatory bowel disease (IBD), and its treatment has not been studied. Objective: The aim of this study was to compare the efficacy and safety of three vitamin D repletion regimens. Design and Setting: We conducted a randomized, controlled clinical trial from November 2007 to June 2010 at the Clinical and Translational Study Unit of Children's Hospital Boston. The study was not blinded to participants and investigators. Patients: Eligibility criteria included diagnosis of IBD, age 5–21, and serum 25OHD concentration below 20 ng/ml. Seventy-one patients enrolled, 61 completed the trial, and two withdrew due to adverse events. Intervention: Patients received orally for 6 wk: vitamin D2, 2,000 IU daily (arm A, control); vitamin D3, 2,000 IU daily (arm B); vitamin D2, 50,000 IU weekly (arm C); and an age-appropriate calcium supplement. Main Outcome Measure: We measured the change in serum 25OHD concentration (Δ25OHD) (ng/ml). Secondary outcomes included change in serum intact PTH concentration (ΔPTH) (pg/ml) and the adverse event occurrence rate. Results: After 6 wk, Δ25OHD ± se was: 9.3 ± 1.8 (arm A); 16.4 ± 2.0 (arm B); 25.4 ± 2.5 (arm C); P (A vs. C) = 0.0004; P (A vs. B) = 0.03. ΔPTH ± se was −5.6 ± 5.5 (arm A); −0.1 ± 4.2 (arm B); −4.4 ± 3.9 (arm C); P = 0.57. No participant experienced hypercalcemia or hyperphosphatemia, and the prevalence of hypercalciuria did not differ among arms at follow-up. Conclusions: Oral doses of 2,000 IU vitamin D3 daily and 50,000 IU vitamin D2 weekly for 6 wk are superior to 2,000 IU vitamin D2 daily for 6 wk in raising serum 25OHD concentration and are well-tolerated among children and adolescents with IBD. The change in serum PTH concentration did not differ among arms. PMID:22456619

Pharmacist-led management of chronic pain in primary care: results from a randomised controlled exploratory trial

PubMed Central

Bruhn, Hanne; Bond, Christine M; Elliott, Alison M; Hannaford, Philip C; Lee, Amanda J; McNamee, Paul; Smith, Blair H; Watson, Margaret C; Holland, Richard; Wright, David

2013-01-01

Objectives To compare the effectiveness of pharmacist medication review, with or without pharmacist prescribing, with standard care, for patients with chronic pain. Design An exploratory randomised controlled trial. Setting Six general practices with prescribing pharmacists in Grampian (3) and East Anglia (3). Participants Patients on repeat prescribed pain medication (4815) were screened by general practitioners (GPs), and mailed invitations (1397). 196 were randomised and 180 (92%) completed. Exclusion criteria included: severe mental illness, terminally ill, cancer related pain, history of addiction. Randomisation and intervention Patients were randomised using a remote telephone service to: (1) pharmacist medication review with face-to-face pharmacist prescribing; (2) pharmacist medication review with feedback to GP and no planned patient contact or (3) treatment as usual (TAU). Blinding was not possible. Outcome measures Outcomes were the SF-12v2, the Chronic Pain Grade (CPG), the Health Utilities Index 3 and the Hospital Anxiety and Depression Scale (HADS). Outcomes were collected at 0, 3 and 6 months. Results In the prescribing arm (n=70) two patients were excluded/nine withdrew. In the review arm (n=63) one was excluded/three withdrew. In the TAU arm (n=63) four withdrew. Compared with baseline, patients had an improved CPG in the prescribing arm, 47.7% (21/44; p=0.003) and in the review arm, 38.6% (17/44; p=0.001), but not the TAU group, 31.3% (15/48; ns). The SF-12 Physical Component Score showed no effect in the prescribing or review arms but improvement in TAU (p=0.02). The SF-12 Mental Component Score showed no effect for the prescribing or review arms and deterioration in the TAU arm (p=0.002). HADS scores improved within the prescribing arm for depression (p=0.022) and anxiety (p=0.007), between groups (p=0.022 and p=0.045, respectively). Conclusions This is the first randomised controlled trial of pharmacist prescribing in the UK, and suggests that there may be a benefit for patients with chronic pain. A larger trial is required. Trial registration: www.isrctn.org/ISRCTN06131530. Medical Research Council funding. PMID:23562814

Chemoprevention of Nonmelanoma Skin Cancer With Celecoxib: A Randomized, Double-Blind, Placebo-Controlled Trial

PubMed Central

Viner, Jaye L.; Pentland, Alice P.; Cantrell, Wendy; Bailey, Howard; Kang, Sewon; Linden, Kenneth G.; Heffernan, Michael; Duvic, Madeleine; Richmond, Ellen; Elewski, Boni E.; Umar, Asad; Bell, Walter; Gordon, Gary B.

2010-01-01

Background Preclinical studies indicate that the enzyme cyclooxygenase 2 plays an important role in ultraviolet-induced skin cancers. We evaluated the efficacy and safety of celecoxib, a cyclooxygenase 2 inhibitor, as a chemopreventive agent for actinic keratoses, the premalignant precursor of nonmelanoma skin cancers, and for nonmelanoma skin cancers, including cutaneous squamous cell carcinomas (SCCs) and basal cell carcinomas (BCCs). Methods A double-blind placebo-controlled randomized trial involving 240 subjects aged 37–87 years with 10–40 actinic keratoses was conducted at eight US academic medical centers. Patients were randomly assigned to receive 200 mg of celecoxib or placebo administered orally twice daily for 9 months. Subjects were evaluated at 3, 6, 9 (ie, completion of treatment), and 11 months after randomization. The primary endpoint was the number of new actinic keratoses at the 9-month visit as a percentage of the number at the time of randomization. In an intent-to-treat analysis, the incidence of actinic keratoses was compared between the two groups using t tests. In exploratory analyses, we evaluated the number of nonmelanoma skin cancers combined and SCCs and BCCs separately per patient at 11 months after randomization using Poisson regression, after adjustment for patient characteristics and time on study. The numbers of adverse events in the two treatment arms were compared using χ2 or Fisher exact tests. All statistical tests were two-sided. Results There was no difference in the incidence of actinic keratoses between the two groups at 9 months after randomization. However, at 11 months after randomization, there were fewer nonmelanoma skin cancers in the celecoxib arm than in the placebo arm (mean cumulative tumor number per patient 0.14 vs 0.35; rate ratio [RR] = .43, 95% confidence interval [CI] = 0.24 to 0.75; P = .003). After adjusting for age, sex, Fitzpatrick skin type, history of actinic keratosis at randomization, nonmelanoma skin cancer history, and patient time on study, the number of nonmelanoma skin cancers was lower in the celecoxib arm than in the placebo arm (RR = 0.41, 95% CI = 0.23 to 0.72, P = .002) as were the numbers of BCCs (RR = 0.40, 95% CI = 0.18 to 0.93, P = .032) and SCCs (RR = 0.42, 95% CI = 0.19 to 0.93, P = .032). Serious and cardiovascular adverse events were similar in the two groups. Conclusions Celecoxib may be effective for prevention of SCCs and BCCs in individuals who have extensive actinic damage and are at high risk for development of nonmelanoma skin cancers. PMID:21115882

A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans

DTIC Science & Technology

2015-10-01

female; mean age= 48). Three-month posttesting compliance is 82% (136 eligible for 3-month posttesting as of September 30, 2015 with 112 actually... posttested ). Task 6: Delivery of Treatments (on target) Through the end of September, 2015, 157 subjects have been randomized which meets our target...in the Appendices section. The data is presented by treatment arm in a blinded manner. Posttest data is not being analyzed or presented in any form

Robot-assisted thoracoscopic surgery with simple laparoscopy for diaphragm eventration.

PubMed

Ahn, Joong Hyun; Suh, Jong Hui; Jeong, Jin Yong

2013-09-01

Robot-assisted thoracoscopic surgery has been applied for general thoracic operations. Its advantages include not only those of minimally invasive surgery but also those of magnified three-dimensional vision and angulation of the robotic arm. However, there are no direct tactile sensation and force feedback, which can cause unwanted organ damage. We therefore used laparoscopy simultaneously to avoid a blind intraperitoneal area during robotic surgery for diaphragmatic eventration via transthoracic approach and describe the technique herein. Georg Thieme Verlag KG Stuttgart · New York.

Blindness prevention programmes: past, present, and future.

PubMed Central

Resnikoff, S.; Pararajasegaram, R.

2001-01-01

Blindness and visual impairment have far-reaching implications for society, the more so when it is realized that 80% of visual disability is avoidable. The marked increase in the size of the elderly population, with their greater propensity for visually disabling conditions, presents a further challenge in this respect. However, if available knowledge and skills were made accessible to those communities in greatest need, much of this needless blindness could be alleviated. Since its inception over 50 years ago, and beginning with trachoma control, WHO has spearheaded efforts to assist Member States to meet the challenge of needless blindness. Since the establishment of the WHO Programme for the Prevention of Blindness in 1978, vast strides have been made through various forms of technical support to establish national prevention of blindness programmes. A more recent initiative, "The Global Initiative for the Elimination of Avoidable Blindness" (referred to as "VISION 2020--The Right to Sight"), launched in 1999, is a collaborative effort between WHO and a number of international nongovernmental organizations and other interested partners. This effort is poised to take the steps necessary to achieve the goal of eliminating avoidable blindness worldwide by the year 2020. PMID:11285666

Technique for long and absolute distance measurement based on laser pulse repetition frequency sweeping

NASA Astrophysics Data System (ADS)

Castro Alves, D.; Abreu, Manuel; Cabral, A.; Jost, Michael; Rebordão, J. M.

2017-11-01

In this work we present a technique to perform long and absolute distance measurements based on mode-locked diode lasers. Using a Michelson interferometer, it is possible to produce an optical cross-correlation between laser pulses of the reference arm with the pulses from the measurement arm, adjusting externally their degree of overlap either changing the pulse repetition frequency (PRF) or the position of the reference arm mirror for two (or more) fixed frequencies. The correlation of the travelling pulses for precision distance measurements relies on ultra-short pulse durations, as the uncertainty associated to the method is dependent on the laser pulse width as well as on a highly stable PRF. Mode-locked Diode lasers are a very appealing technology for its inherent characteristics, associated to compactness, size and efficiency, constituting a positive trade-off with regard to other mode-locked laser sources. Nevertheless, main current drawback is the non-availability of frequency-stable laser diodes. The laser used is a monolithic mode-locked semiconductor quantum-dot (QD) laser. The laser PRF is locked to an external stabilized RF reference. In this work we will present some of the preliminary results and discuss the importance of the requirements related to laser PRF stability in the final metrology system accuracy.

Inconsistency between simultaneous blood pressure measurements in the arm, forearm, and leg in anesthetized children.

PubMed

Keidan, Ilan; Sidi, Avner; Ben-Menachem, Erez; Tene, Yael; Berkenstadt, Haim

2014-02-01

To determine the accuracy and precision of simultaneous noninvasive blood pressure (NIBP) measurement in the arm, forearm, and ankle in anesthetized children. Prospective, randomized study. University medical center. 101 ASA physical status 1 and 2 children (aged 1-8 yrs) scheduled for elective surgery with general anesthesia. Simultaneous NIBP measurements were recorded at the arm, forearm, and ankle at 5-minute intervals. The systolic blood pressure difference between the arm-forearm or the arm-ankle was within the ± 10% range in 63% and 29% of measurements, and within the ± 20% range in 85% and 67% of measurements, respectively. The diastolic blood pressure difference between the arm-forearm or the arm-ankle was within the ± 10% range in 42% and 44% and within the ± 20% range in 67% and 74% of measurements, respectively. In patients in whom the initial three NIBP measurements were within the ± 20% range between the forearm and arm, 86% of the subsequent measurements were also within that limit. Forearm and ankle NIBP measurements are unreliable and inconsistent with NIBP measured in the arm of anesthetized children. These alternative BP measurement sites are not reliable in accuracy (comparison with reference "gold" standard) and precision (reproducibility). Copyright © 2014 Elsevier Inc. All rights reserved.

Involving private practitioners in the Indian tuberculosis programme: a randomised trial.

PubMed

Yellappa, Vijayashree; Battaglioli, Tullia; Gurum, Sanath Kumar; Narayanan, Devadasan; Van der Stuyft, Patrick

2018-05-01

To assess a multicomponent intervention to improve private practitioners (PPs) involvement in referral of presumptive pulmonary TB (PTB) cases to the Revised National TB Control Programme (RNTCP) for sputum examination. Randomised controlled trial. We randomly allocated all 189 eligible PPs in Tumkur city, South India, to intervention or control arm. The intervention, implemented between December 2014 and January 2016, included two sets of activities, one targeted at health system strengthening (building RNTCP staff capacity to collaborate with PPs, provision of feedback on referrals through SMS) and one targeted at intervention PPs (training in RNTCP, provision of referral pads and education materials and monthly visits to PPs by RNTCP staff). Crude and adjusted referral and PTB case-finding rate ratios were calculated with negative binomial regression. PPs referred 836 individuals (548 from intervention and 169 from control arm PPs) of whom 176 were diagnosed with bacteriologically confirmed PTB. The proportion (95% confidence interval) of referring PPs [0.59 (0.49, 0.68) vs. 0.42 (0.32, 0.52) in the intervention and control arm, respectively], mean referral rate per PP-year [(5.7 (3.8, 8.7) vs. 1.8 (1.2, 2.8)] and smear-positive PTB case-finding rate per PP-year [(1.5 (0.9, 2.2) vs. 0.6 (0.3, 0.9)] were significantly higher in the intervention than the control arm. Stratifying by qualification, a statistically significant difference in the above indicators remained only among GPs and internists. Overall, surgeons, paediatricians and gynaecologists referred few patients. PP referrals contributed to 20% of the sputum smear positive PTB cases detected by RNTCP in Tumkur city (14% were from intervention arm PPs). We demonstrated the effectiveness of a health system-oriented intervention to improve PP's referrals of presumptive PTB cases to RNTCP. © 2018 John Wiley & Sons Ltd.

Model-Based Referenceless Quality Metric of 3D Synthesized Images Using Local Image Description.

PubMed

Gu, Ke; Jakhetiya, Vinit; Qiao, Jun-Fei; Li, Xiaoli; Lin, Weisi; Thalmann, Daniel

2017-07-28

New challenges have been brought out along with the emerging of 3D-related technologies such as virtual reality (VR), augmented reality (AR), and mixed reality (MR). Free viewpoint video (FVV), due to its applications in remote surveillance, remote education, etc, based on the flexible selection of direction and viewpoint, has been perceived as the development direction of next-generation video technologies and has drawn a wide range of researchers' attention. Since FVV images are synthesized via a depth image-based rendering (DIBR) procedure in the "blind" environment (without reference images), a reliable real-time blind quality evaluation and monitoring system is urgently required. But existing assessment metrics do not render human judgments faithfully mainly because geometric distortions are generated by DIBR. To this end, this paper proposes a novel referenceless quality metric of DIBR-synthesized images using the autoregression (AR)-based local image description. It was found that, after the AR prediction, the reconstructed error between a DIBR-synthesized image and its AR-predicted image can accurately capture the geometry distortion. The visual saliency is then leveraged to modify the proposed blind quality metric to a sizable margin. Experiments validate the superiority of our no-reference quality method as compared with prevailing full-, reduced- and no-reference models.

DoD Task Force to Improve Industrial Responsiveness.

DTIC Science & Technology

1982-03-01

more elements of the Improvement Triad. The directives and other documents revised or developed, and their relationship to the Improvement Triad, is...2010.6, reference (e)) 8. Although a proper arms-length business relationship with industry must be maintained in order to protect the public interest...and to foster competi- tion, a strong industrial base is necessary for a strong defense. The proper arms-length buyer-seller relationship should not

Mediterranean Security Into the Coming Millennium

DTIC Science & Technology

1999-01-01

forgery was the widespread forgery of the Deutschmark, the reference currency in the area, in order to finance the costs of the wars of Yugoslavia’ s...Basque Land and Freedom) FAZ Frankfurter Allgemeine Zeitung FT Financial Times FSU Former Soviet Union GIA Groupe Islamique Anne (Algeria, Armed...and inter-state conflict as well as terrorism start the vicious circles of drugs and displaced persons trafficking in order to finance arms transfers

Hand-arm vibration syndrome: What family physicians should know.

PubMed

Shen, Shixin Cindy; House, Ronald A

2017-03-01

To provide family physicians with an understanding of the epidemiology, pathogenesis, symptoms, diagnosis, and management of hand-arm vibration syndrome (HAVS), an important and common occupational disease in Canada. A MEDLINE search was conducted for research and review articles on HAVS. A Google search was conducted to obtain gray literature relevant to the Canadian context. Additional references were obtained from the articles identified. Hand-arm vibration syndrome is a prevalent occupational disease affecting workers in multiple industries in which vibrating tools are used. However, it is underdiagnosed in Canada. It has 3 components-vascular, in the form of secondary Raynaud phenomenon; sensorineural; and musculoskeletal. Hand-arm vibration syndrome in its more advanced stages contributes to substantial disability and poor quality of life. Its diagnosis requires careful history taking, in particular occupational history, physical examination, laboratory tests to rule out alternative diagnoses, and referral to an occupational medicine specialist for additional investigations. Management involves reduction of vibration exposure, avoidance of cold conditions, smoking cessation, and medication. To ensure timely diagnosis of HAVS and improve prognosis and quality of life, family physicians should be aware of this common occupational disease and be able to elicit the relevant occupational history, refer patients to occupational medicine clinics, and appropriately initiate compensation claims. Copyright© the College of Family Physicians of Canada.

Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial.

PubMed

Street, Alexander J; Magee, Wendy L; Bateman, Andrew; Parker, Michael; Odell-Miller, Helen; Fachner, Jorg

2018-01-01

To assess the feasibility of a randomized controlled trial to evaluate music therapy as a home-based intervention for arm hemiparesis in stroke. A pilot feasibility randomized controlled trial, with cross-over design. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes. Participants' homes across Cambridgeshire, UK. Eleven people with stroke and arm hemiparesis, 3-60 months post stroke, following discharge from community rehabilitation. Each participant engaged in therapeutic instrumental music performance in 12 individual clinical contacts, twice weekly for six weeks. Feasibility was estimated by recruitment from three community stroke teams over a 12-month period, attrition rates, completion of treatment and successful data collection. Structured interviews were conducted pre and post intervention to establish participant tolerance and preference. Action Research Arm Test and Nine-hole Peg Test data were collected at weeks 1, 6, 9, 15 and 18, pre and post intervention by a blinded assessor. A total of 11 of 14 invited participants were recruited (intervention n = 6, waitlist n = 5). In total, 10 completed treatment and data collection. It cannot be concluded whether a larger trial would be feasible due to unavailable data regarding a number of eligible patients screened. Adherence to treatment, retention and interview responses might suggest that the intervention was motivating for participants. ClinicalTrials.gov identifier NCT 02310438.

End-tidal concentration of sevoflurane for preventing rocuronium-induced withdrawal of the arm in pediatric patients.

PubMed

Yeom, Jong Hoon; Kim, Yong Oh; Lee, Jae Min; Jeon, Woo Jae

2014-04-01

During induction of general anesthesia, the intravenous injection of rocuronium is often associated with withdrawal movement of the arm due to pain, and this abrupt withdrawal may result in dislodgement of the venous catheter, injury, or inadequate injection of rocuronium. We performed this study to evaluate the 50 and 95% effective end-tidal concentrations of sevoflurane (ETsev) for preventing rocuronium-induced withdrawal of the arm. We conducted a prospective double-blind study in 31 pediatric patients. After free flow of lactated Ringer's IV fluid was confirmed, anesthesia was induced in the patients by using 2.5% thiopental sodium (4 mg/kg) and sevoflurane (4 vol%) with 6 L/min of oxygen. When the target ETsev was reached, preservative-free 1% lidocaine (1.5 mg/kg) was intravenously injected during manual venous occlusion and rocuronium (0.6 mg/kg) was injected after lidocaine injection under free-flow intravenous fluid. A nurse who was an investigator and was blinded to the ETsev injected the rocuronium. The nurse evaluated the response. Non-withdrawal movement was observed in 5 out of 11 patients with ETsev 3.0 vol% and in 5 out of 6 patients with ETsev 3.5 vol%. By Dixon's up-and-down method, the 50% effective concentration (EC50) of sevoflurane for non-withdrawal movement at rocuronium injection was 3.1 ± 0.4 vol%. A logistic regression curve of the probability of non-withdrawal movements showed that the 50% effective ETsev for abolishing withdrawal movement at rocuronium injection was 2.9 vol% (95% confidence interval [CI] 2.4-3.8 vol%) and the 95% effective ETsev was 4.3 vol% (95% CI 3.6-9.8 vol%). This study showed that the 50 and 95% effective ETsev that prevent withdrawal movement at rocuronium injection are 2.9 and 4.3 vol%, respectively.

Prospective randomized double-blinded trial comparing 2 anti-MRSA agents with supplemental coverage of cefazolin before lower extremity revascularization.

PubMed

Stone, Patrick A; AbuRahma, Ali F; Campbell, James R; Hass, Stephen M; Mousa, Albeir Y; Nanjundappa, Aravinda; Srivastiva, Mohit; Modak, Asmita; Emmett, Mary

2015-09-01

To compare with antibiotics with methicillin-resistant microbial coverage in a prospective fashion. Current antibiotic prophylaxis for vascular procedures includes a first generation cephalosporin. No changes in recommendations have occurred despite changes in reports of incidence of MRSA related surgical site infections. Does supplemental anti-MRSA prophylactic coverage provide a significant reduction in Gram-positive or MRSA infections? Single center prospective double blinded randomized study of patients undergoing lower extremity vascular procedures from 2011 to 2014. One hundred seventy-eight (178) patients were evaluated at 90 days for surgical site infection. Infections were categorized as early infections less than 30 days of the index procedure and late after 90 days. Early vascular surgical site infection occurred in 7(8.24%) of patients in the Vancomycin arm, and 11 (11.83%) in the Daptomycin arm (P = 0.43). Gram-positive related infections and MRSA infections occurred in 1(1.18%)/0(0%) of Vancomycin patients and 9 (9.68%)/1 (1.08%) of Daptomycin patients, respectively (P < 0.02 and P = 1.00). Readmissions related to surgical site infections occurred in 4(4.71%) in the Vancomycin group and 11 (11.8%) in the Daptomycin group (P = 0.11). Patients undergoing operative exploration occurred in 5 (5.88%) in the Vancomycin group and 10 (10.75%) of the Daptomycin group (P = 0.17). Late infections were reported in 3 patients, 2 of which were in the combined Daptomycin group. Median hospital charges related to readmissions due to a surgical site infection was $50,823 in the combination Vancomycin arm and $110,920 in the combination Daptomycin group; however, no statistical significance was appreciated (P = 0.11). Vancomycin supplemental prophylaxis seems to reduce the incidence of Gram-positive infection compared with adding supplemental Daptomycin prophylaxis. The Incidence of MRSA-related surgical site infections is low with the addition of either anti-MRSA agents compared with historical incidence of MRSA-related infection.

A Phenotyping Regimen for Genetically Modified Mice Used to Study Genes Implicated in Human Diseases of Aging.

PubMed

Patterson, Victoria L; Thompson, Brian S; Cherry, Catherine; Wang, Shao-Bin; Chen, Bo; Hoh, Josephine

2016-07-14

Age-related diseases are becoming increasingly prevalent and the burden continues to grow as our population ages. Effective treatments are necessary to lessen the impact of debilitating conditions but remain elusive in many cases. Only by understanding the causes and pathology of diseases associated with aging, can scientists begin to identify potential therapeutic targets and develop strategies for intervention. The most common age-related conditions are neurodegenerative disorders such as Parkinson's disease and blindness. Age-related macular degeneration (AMD) is the leading cause of blindness in the elderly. Genome wide association studies have previously identified loci that are associated with increased susceptibility to this disease and identified two regions of interest: complement factor H (CFH) and the 10q26 locus, where the age-related maculopathy susceptibility 2 (ARMS2) and high-temperature requirement factor A1 (HtrA1) genes are located. CFH acts as a negative regulator of the alternative pathway (AP) of the complement system while HtrA1 is an extracellular serine protease. ARMS2 is located upstream of HtrA1 in the primate genome, although the gene is absent in mice. To study the effects of these genes, humanized knock-in mouse lines of Cfh and ARMS2, knockouts of Cfh, HtrA1, HtrA2, HtrA3 and HtrA4 as well as a conditional neural deletion of HtrA2 were generated. Of all the genetically engineered mice produced only mice lacking HtrA2, either systemically or in neural tissues, displayed clear phenotypes. In order to examine these mice thoroughly and systematically, an initial phenotyping schedule was established, consisting of a series of tests related to two main diseases of interest: AMD and Parkinson's. Genetically modified mice can be subjected to appropriate experiments to identify phenotypes that may be related to the associated diseases in humans. A phenotyping regimen with a mitochondrial focus is presented here alongside representative results from the tests of interest.

Effect of single-dose Ginkgo biloba and Panax ginseng on driving performance.

PubMed

LaSala, Gregory S; McKeever, Rita G; Patel, Urvi; Okaneku, Jolene; Vearrier, David; Greenberg, Michael I

2015-02-01

Panax ginseng and Gingko biloba are commonly used herbal supplements in the United States that have been reported to increase alertness and cognitive function. The objective of this study was to investigate the effects of these specific herbals on driving performance. 30 volunteers were tested using the STISIM3® Driving Simulator (Systems Technology Inc., Hawthorne, CA, USA) in this double-blind, placebo-controlled study. The subjects were randomized into 3 groups of 10 subjects per group. After 10-min of simulated driving, subjects received either ginseng (1200 mg), Gingko (240 mg), or placebo administered orally. The test herbals and placebo were randomized and administered by a research assistant outside of the study to maintain blinding. One hour following administration of the herbals or placebo, the subjects completed an additional 10-min of simulated driving. Standard driving parameters were studied including reaction time, standard deviation of lateral positioning, and divided attention. Data collected for the divided attention parameter included time to response and number of correct responses. The data was analyzed with repeated-measures analysis of variance (ANOVA) and Kruskal-Wallis test using SPSS 22 (IBM, Armonk, NY, USA). There was no difference in reaction time or standard deviation of lateral positioning for both the ginseng and Ginkgo arms. For the divided attention parameter, the response time in the Ginkgo arm decreased from 2.9 to 2.5 s. The ginseng arm also decreased from 3.2 to 2.4 s. None of these values were statistically significant when between group differences were analyzed. The data suggests there was no statistically significant difference between ginseng, Ginkgo or placebo on driving performance. We postulate this is due to the relatively small numbers in our study. Further study with a larger sample size may be needed in order to elucidate more fully the effects of Ginkgo and ginseng on driving ability.

Efficacy and safety of a natural mineral water rich in magnesium and sulphate for bowel function: a double-blind, randomized, placebo-controlled study.

PubMed

Bothe, Gordana; Coh, Aljaz; Auinger, Annegret

2017-03-01

The present placebo-controlled, double-blind, randomized trial aimed to investigate whether a natural mineral water rich in magnesium sulphate and sodium sulphate (Donat Mg) may help to improve bowel function. A total of 106 otherwise healthy subjects with functional constipation were randomly assigned to consume 300 or 500 mL of a natural mineral water as compared to placebo water, over a course of 6 weeks. The 300-mL arms were terminated due to the results of a planned interim analysis. Subjects documented the complete spontaneous bowel movements, spontaneous and overall bowel movements/week, stool consistency, gastrointestinal symptoms and general well-being in a diary. Change in the number of complete spontaneous bowel movements was defined as the primary outcome. For the 75 subjects in the 500-mL arms, the change in the number of complete spontaneous bowel movements per week tended to be higher in the active group when compared to placebo after 6 weeks (T2 = 1.8; p value  = 0.036; one-sided). The mean number of spontaneous bowel movements significantly increased over the course of the study, with significant differences between study arms considering the whole study time (F test = 4.743; p time × group  = 0.010, 2-sided). Stool consistency of spontaneous bowel movements (p < 0.001) and the subjectively perceived symptoms concerning constipation (p = 0.005) improved significantly with the natural mineral water as compared to placebo. The daily consumption of a natural mineral water rich in magnesium sulphate and sodium sulphate improved bowel movement frequency and stool consistency in subjects with functional constipation. Moreover, the subjects' health-related quality of life improved. EudraCT No 2012-005130-11.

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of a Chemokine Receptor 5 (CCR5) Antagonist to Decrease the Occurrence of Immune Reconstitution Inflammatory Syndrome in HIV-Infection: The CADIRIS Study.

PubMed

Sierra-Madero, Juan G; Ellenberg, Susan; Rassool, Mohammed S; Tierney, Ann; Belaunzarán-Zamudio, Pablo F; López-Martínez, Alondra; Piñeirúa-Menéndez, Alicia; Montaner, Luis J; Azzoni, Livio; Benítez, César Rivera; Sereti, Irini; Andrade-Villanueva, Jaime; Mosqueda-Gómez, Juan L; Rodriguez, Benigno; Sanne, Ian; Lederman, Michael M

2014-11-01

Immune Reconstitution Inflammatory Syndrome (IRIS) is a common complication of antiretroviral therapy (ART) in HIV-infected patients. IRIS is associated with an increased risk of hospitalization and death. We ascertained whether CCR5 blockade using maraviroc reduces the risk of IRIS. The CADIRIS study was a randomized, double-blind, placebo-controlled, clinical trial that accrued subjects from five clinical sites in Mexico and one in South Africa between November 2009 and January 2012, and followed them for one year. The primary outcome was occurrence of IRIS by 24 weeks. HIV-infected adults, naïve to ART, with CD4 cells <100/μL, and HIVRNA >1,000 copies/mL were eligible. We screened 362 subjects; 279 met inclusion criteria, 3 refused participation, and 276 were randomized. Participants received maraviroc 600 mg twice daily or placebo added to an ART regimen that included tenofovir, emtricitabine, and efavirenz for 48 weeks. There were 276 patients randomized (140 received maraviroc and 136 placebo). There was no difference in the time to IRIS events between treatment arms (HR 1·08, 95% CI (0·66, 1·77), log-rank test p =0·743). In total, 64 (23%) patients had IRIS events, 33 (24%) in the maraviroc arm and 31 (23%) in the placebo arm ( p =0·88). Maraviroc had no significant effect on frequency, time or severity of IRIS events after ART initiation. Including a CCR5 inhibitor in an initial treatment regimen does not confer a meaningful protection from the occurrence of IRIS in persons with advanced HIV infection. The trial was funded as investigator initiated research by Pfizer Inc, New York, NY, USA. ClinicalTrials.gov . ID: NCT00988780 (http://clinicaltrials.gov/ct2/show/NCT00988780).

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of a Chemokine Receptor 5 (CCR5) Antagonist to Decrease the Occurrence of Immune Reconstitution Inflammatory Syndrome in HIV-Infection: The CADIRIS Study

PubMed Central

Sierra-Madero, Juan G.; Ellenberg, Susan; Rassool, Mohammed S.; Tierney, Ann; Belaunzarán-Zamudio, Pablo F.; López-Martínez, Alondra; Piñeirúa-Menéndez, Alicia; Montaner, Luis J.; Azzoni, Livio; Benítez, César Rivera; Sereti, Irini; Andrade-Villanueva, Jaime; Mosqueda-Gómez, Juan L.; Rodriguez, Benigno; Sanne, Ian; Lederman, Michael M.

2015-01-01

Background Immune Reconstitution Inflammatory Syndrome (IRIS) is a common complication of antiretroviral therapy (ART) in HIV-infected patients. IRIS is associated with an increased risk of hospitalization and death. We ascertained whether CCR5 blockade using maraviroc reduces the risk of IRIS. Methods The CADIRIS study was a randomized, double-blind, placebo-controlled, clinical trial that accrued subjects from five clinical sites in Mexico and one in South Africa between November 2009 and January 2012, and followed them for one year. The primary outcome was occurrence of IRIS by 24 weeks. HIV-infected adults, naïve to ART, with CD4 cells <100/μL, and HIVRNA >1,000 copies/mL were eligible. We screened 362 subjects; 279 met inclusion criteria, 3 refused participation, and 276 were randomized. Participants received maraviroc 600 mg twice daily or placebo added to an ART regimen that included tenofovir, emtricitabine, and efavirenz for 48 weeks. Findings There were 276 patients randomized (140 received maraviroc and 136 placebo). There was no difference in the time to IRIS events between treatment arms (HR 1·08, 95% CI (0·66, 1·77), log-rank test p=0·743). In total, 64 (23%) patients had IRIS events, 33 (24%) in the maraviroc arm and 31 (23%) in the placebo arm (p=0·88). Interpretation Maraviroc had no significant effect on frequency, time or severity of IRIS events after ART initiation. Including a CCR5 inhibitor in an initial treatment regimen does not confer a meaningful protection from the occurrence of IRIS in persons with advanced HIV infection. Funding The trial was funded as investigator initiated research by Pfizer Inc, New York, NY, USA. Trial Registration ClinicalTrials.gov. ID: NCT00988780 (http://clinicaltrials.gov/ct2/show/NCT00988780) PMID:26366430

QADATA user's manual; an interactive computer program for the retrieval and analysis of the results from the external blind sample quality- assurance project of the U.S. Geological Survey

USGS Publications Warehouse

Lucey, K.J.

1990-01-01

The U.S. Geological Survey conducts an external blind sample quality assurance project for its National Water Quality Laboratory in Denver, Colorado, based on the analysis of reference water samples. Reference samples containing selected inorganic and nutrient constituents are disguised as environmental samples at the Survey 's office in Ocala, Florida, and are sent periodically through other Survey offices to the laboratory. The results of this blind sample project indicate the quality of analytical data produced by the laboratory. This report provides instructions on the use of QADATA, an interactive, menu-driven program that allows users to retrieve the results of the blind sample quality- assurance project. The QADATA program, which is available on the U.S. Geological Survey 's national computer network, accesses a blind sample data base that contains more than 50,000 determinations from the last five water years for approximately 40 constituents at various concentrations. The data can be retrieved from the database for any user- defined time period and for any or all available constituents. After the user defines the retrieval, the program prepares statistical tables, control charts, and precision plots and generates a report which can be transferred to the user 's office through the computer network. A discussion of the interpretation of the program output is also included. This quality assurance information will permit users to document the quality of the analytical results received from the laboratory. The blind sample data is entered into the database within weeks after being produced by the laboratory and can be retrieved to meet the needs of specific projects or programs. (USGS)

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

Electroacupuncture for chemotherapy-induced peripheral neuropathy: study protocol for a pilot multicentre randomized, patient-assessor-blinded, controlled trial

PubMed Central

2013-01-01

Background Chemotherapy-induced peripheral neuropathy (CIPN) is the main dose-limiting side effect of neurotoxic chemotherapeutic agents. CIPN can lead not only to loss of physical function, difficulties in activities of daily living (ADLs), and decreased quality of life, but also to dose reduction, delay or even cessation of treatment. Currently, there are few proven effective treatments for CIPN. This randomized controlled clinical trial is designed to evaluate the effects and safety of electroacupuncture (EA) for patients with CIPN. Methods/design This is a multicenter, two-armed, parallel-design, patient-assessor-blinded, randomized, sham-controlled clinical trial. Forty eligible patients with CIPN will be randomized in a ratio of 1:1 to the EA or sham EA arms. During the treatment phase, patients will undergo eight sessions of verum EA or sham EA twice weekly for four weeks, and then will be followed-up for eight weeks. Electrical stimulation in the EA group will consist of a mixed frequency of 2/120 Hz and 80% of bearable intensity. Sham EA will be applied to non-acupoints, with shallow needle insertion and no current. All outcomes and analyses of results will be assessed by researchers blinded to treatment allocation. The effects of EA on CIPN will be evaluated according to both subjective and objective outcome measures. The primary outcome measure will be the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire to assess CIPN (QLQ-CIPN20). The secondary outcome measures will be the results on the numerical rating scale, the Semmes-Weinstein monofilament test, the nerve conduction study, and the EORTC QLQ-C30, as well as the patient’s global impression of change and adverse events. Safety will be assessed at each visit. Discussion The results of this on-going study will provide clinical evidence for the effects and safety of EA for CIPN compared with sham EA. Trial registration Clinical Research Information Service: KCT0000506 PMID:23945074

Treatment assignment guesses by study participants in a double-blind dose escalation clinical trial of saw palmetto.

PubMed

Lee, Jeannette Y; Moore, Page; Kusek, John; Barry, Michael

2014-01-01

This report assesses participant perception of treatment assignment in a randomized, double-blind, placebo-controlled trial of saw palmetto for the treatment of benign prostatic hyperplasia (BCM). Participants randomized to receive saw palmetto were instructed to take one 320 mg gelcap daily for the first 24 weeks, two 320 mg gelcaps daily for the second 24 weeks, and three 320 mg gelcaps daily for the third 24 weeks. Study participants assigned to placebo were instructed to take the same number of matching placebo gelcaps in each time period. At 24, 48, and 72 weeks postrandomization, the American Urological Association Symptom Index (AUA-SI) was administered and participants were asked to guess their treatment assignment. The study was conducted at 11 clinical centers in North America. Study participants were men, 45 years and older, with moderate to low severe BPH symptoms, randomized to saw palmetto (N=151) or placebo (N=155). Treatment arms were compared with respect to the distribution of participant guesses of treatment assignment. For participants assigned to saw palmetto, 22.5%, 24.7%, and 29.8% correctly thought they were taking saw palmetto, and 37.3%, 40.0%, and 44.4% incorrectly thought they were on placebo at 24, 48, and 72 weeks, respectively. For placebo participants, 21.8%, 27.4%, and 25.2% incorrectly thought they were on saw palmetto, and 41.6%, 39.9%, and 42.6% correctly thought they were on placebo at 24, 48, and 72 weeks, respectively. The treatment arms did not vary with respect to the distributions of participants who guessed they were on saw palmetto (p=0.823) or placebo (p=0.893). Participants who experienced an improvement in AUA-SI were 2.16 times more likely to think they were on saw palmetto. Blinding of treatment assignment was successful in this study. Improvement in BPH-related symptoms was associated with the perception that participants were taking saw palmetto.

Propranolol, clonidine, urapidil and trazodone infusion in essential tremor: a double-blind crossover trial.

PubMed

Caccia, M R; Osio, M; Galimberti, V; Cataldi, G; Mangoni, A

1989-05-01

Accelerometric tremorgrams were recorded from 25 subjects affected by essential tremor and analysed by a Berg-Fourier frequency analyser before and during venous infusion of the following drugs: propranolol (beta-blocker), clonidine (alpha-presynaptic adrenergic agonist), urapidil (alpha-postsynaptic blocker), trazodone (adrenolytic agent) and placebo. The washout interval between infusions was 3 days. Recordings and data analyses were performed in a double-blind crossover trial. Tremor was classified as: at rest; postural (arms hyperextended); and intention (finger-nose test). Analysis of the results showed that propranolol and clonidine reduced significantly (P = 0.01 and P = 0.009, respectively) the power spectrum of postural tremor, but left at rest and intention tremors unchanged. No significant effects on the tremor power spectrum were observed after placebo, urapidil or trazodone administration. None of the drugs had any effect on tremor frequency.

Accurate positioning of long, flexible ARM's (Articulated Robotic Manipulator)

NASA Technical Reports Server (NTRS)

Malachowski, Michael J.

1988-01-01

An articulated robotic manipulator (ARM) system is being designed for space applications. Work being done on a concept utilizing an infinitely stiff laser beam for position reference is summarized. The laser beam is projected along the segments of the ARM, and the position is sensed by the beam rider modules (BRM) mounted on the distal ends of the segments. The BRM concept is the heart of the system. It utilizes a combination of lateral displacements and rotational and distance measurement sensors. These determine the relative position of the two ends of the segments with respect to each other in six degrees of freedom. The BRM measurement devices contain microprocessor controlled data acquisition and active positioning components. An indirect adaptive controller is used to accurately control the position of the ARM.

A Completely Blind Video Integrity Oracle.

PubMed

Mittal, Anish; Saad, Michele A; Bovik, Alan C

2016-01-01

Considerable progress has been made toward developing still picture perceptual quality analyzers that do not require any reference picture and that are not trained on human opinion scores of distorted images. However, there do not yet exist any such completely blind video quality assessment (VQA) models. Here, we attempt to bridge this gap by developing a new VQA model called the video intrinsic integrity and distortion evaluation oracle (VIIDEO). The new model does not require the use of any additional information other than the video being quality evaluated. VIIDEO embodies models of intrinsic statistical regularities that are observed in natural vidoes, which are used to quantify disturbances introduced due to distortions. An algorithm derived from the VIIDEO model is thereby able to predict the quality of distorted videos without any external knowledge about the pristine source, anticipated distortions, or human judgments of video quality. Even with such a paucity of information, we are able to show that the VIIDEO algorithm performs much better than the legacy full reference quality measure MSE on the LIVE VQA database and delivers performance comparable with a leading human judgment trained blind VQA model. We believe that the VIIDEO algorithm is a significant step toward making real-time monitoring of completely blind video quality possible.

First-Line Therapy for Human Cutaneous Leishmaniasis in Peru Using the TLR7 Agonist Imiquimod in Combination with Pentavalent Antimony

PubMed Central

Miranda-Verastegui, Cesar; Tulliano, GianFranco; Gyorkos, Theresa W.; Calderon, Wessmark; Rahme, Elham; Ward, Brian; Cruz, Maria; Llanos-Cuentas, Alejandro; Matlashewski, Greg

2009-01-01

Background Current therapies for cutaneous leishmaniasis are limited by poor efficacy, long-term course of treatment, and the development of resistance. We evaluated if pentavalent antimony (an anti-parasitic drug) combined with imiquimod (an immunomodulator) was more effective than pentavalent antimony alone in patients who had not previously been treated. Methods A randomized double-blind clinical trial involving 80 cutaneous leishmaniasis patients was conducted in Peru. The study subjects were recruited in Lima and Cusco (20 experimental and 20 control subjects at each site). Experimental arm: Standard dose of pentavalent antimony plus 5% imiquimod cream applied to each lesion three times per week for 20 days. Control arm: Standard dose of pentavalent antimony plus placebo (vehicle cream) applied as above. The primary outcome was cure defined as complete re-epithelization with no inflammation assessed during the 12 months post-treatment period. Results Of the 80 subjects enrolled, 75 completed the study. The overall cure rate at the 12-month follow-up for the intention-to-treat analysis was 75% (30/40) in the experimental arm and 58% (23/40) in the control arm (p = 0.098). Subgroup analyses suggested that combination treatment benefits were most often observed at the Cusco site, where L. braziliensis is the prevalent species. Over the study period, only one adverse event (rash) was recorded, in the experimental arm. Conclusion The combination treatment of imiquimod plus pentavalent antimony performed better than placebo plus pentavalent antimony, but the difference was not statistically significant. Trial Registration Clinical Trials.gov NCT00257530 PMID:19636365

Effect of oseltamivir, zanamivir or oseltamivir-zanamivir combination treatments on transmission of influenza in households.

PubMed

Carrat, Fabrice; Duval, Xavier; Tubach, Florence; Mosnier, Anne; Van der Werf, Sylvie; Tibi, Annick; Blanchon, Thierry; Leport, Catherine; Flahault, Antoine; Mentré, France

2012-01-01

The effectiveness of neuraminidase inhibitors to reduce transmission when used as treatment in influenza-infected patients remains debated. In a prespecified analysis of a blinded randomized controlled trial on the efficacy of oseltamivir-zanamivir combination therapy versus oseltamivir and zanamivir monotherapy conducted during the 2008-2009 seasonal influenza epidemic, we compared the rate of secondary illness in household contacts of influenza-positive index patients between arms. Secondary illness was defined as occurrence in contacts of fever plus cough within 7 days from randomization of index patients. Analyses were conducted according to the delay between patients' onset of symptoms and intervention. A total of 543 household contacts of 267 index patients were included, of which 466 had follow-up assessment. A secondary illness was reported in 58 (12.5%) contacts with no significant difference between arms overall (P=0.07). When the analysis was limited to the 232 contacts of 136 index patients with first treatment intake within 24 h of onset of symptoms, a lower rate of secondary illness was reported in the combination therapy arm (2 of 56 [4%]) than in the oseltamivir arm (14 of 81 [17%]; P=0.014) and the zanamivir arm (14 of 95 [15%]; P=0.031). Multivariate analysis accounting for intra-household correlation confirmed these findings. Our analysis suggests a greater effectiveness of the combination therapy to reduce transmissibility when given to the index patient within 24 h of onset of symptoms. As the finding was obtained from a subgroup analysis, it should be interpreted with caution.

Moxifloxacin in Pediatric Patients with Complicated Intra-Abdominal Infections: Results of the MOXIPEDIA Randomized Controlled Study.

PubMed

Wirth, Stefan; Emil, Sherif G S; Engelis, Arnis; Digtyar, Valeri; Criollo, Margarita; DiCasoli, Carl; Stass, Heino; Willmann, Stefan; Nkulikiyinka, Richard; Grossmann, Ulrike

2018-01-18

This study was designed to evaluate primarily the safety and also the efficacy of moxifloxacin (MXF) in children with complicated intra-abdominal infections (cIAIs). In this multicenter, randomized, double-blind, controlled study, 451 pediatric patients aged 3 months to 17 years with cIAIs were treated with intravenous/oral MXF (N = 301) or comparator (COMP, intravenous ertapenem followed by oral amoxicillin/clavulanate; N = 150) for 5 to 14 days. Doses of MXF were selected based on the results of a Phase 1 study in pediatric patients (NCT01049022). The primary endpoint was safety, with particular focus on cardiac and musculoskeletal safety; clinical and bacteriological efficacy at test of cure were also investigated. The proportion of patients with adverse events (AEs) was comparable between the two treatment arms (MXF: 58.1% and COMP: 54.7%). The incidence of drug-related AEs was higher in the MXF arm than the COMP arm (14.3% and 6.7%, respectively). No cases of QTc interval prolongation-related morbidity or mortality were observed. The proportion of patients with musculoskeletal AEs was comparable between treatment arms; no drug-related events were reported. Clinical cure rates were 84.6% and 95.5% in the MXF and COMP arms, respectively, in patients with confirmed pathogen(s) at baseline. MXF treatment was well tolerated in children with cIAIs. However, a lower clinical cure rate was observed with MXF treatment compared with COMP. This study does not support a recommendation of MXF for children with cIAIs when alternative more efficacious antibiotics with better safety profile are available.

Effects of a Home-Based Upper Limb Training Program in Patients With Multiple Sclerosis: A Randomized Controlled Trial.

PubMed

Ortiz-Rubio, Araceli; Cabrera-Martos, Irene; Rodríguez-Torres, Janet; Fajardo-Contreras, Waldo; Díaz-Pelegrina, Ana; Valenza, Marie Carmen

2016-12-01

To evaluate the effects of a home-based upper limb training program on arm function in patients with multiple sclerosis (MS). Additionally, the effects of this program on manual dexterity, handgrip strength, and finger prehension force were analyzed. Randomized, single-blind controlled trial. Home based. Patients with a clinical diagnosis of MS acknowledging impaired manual ability (N=37) were randomized into 2 groups. Patients in the experimental group were included in a supervised home-based upper limb training program for 8 weeks twice a week. Patients in the control group received information in the form of a leaflet with a schedule of upper limb exercise training. The primary outcome measure was arm function (motor functioning assessed using the finger tapping test and a functional measure, the Action Research Arm Test). The secondary outcome measures were manual dexterity assessed with the Purdue Pegboard Test and handgrip strength and finger prehension force evaluated with a handgrip and a pinch dynamometer, respectively. After 8 weeks, a significant between-group improvement (P<.05) was found on the Action Research Arm Test bilaterally and the finger tapping test in the most affected upper limb. The secondary outcomes also improved in the most affected limb in the experimental group. An 8-week home-based intervention program focused on upper limbs twice a week improved arm function and physiologic variables with a primary focus on the more affected extremity in patients with MS compared with the control group. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Brief Report: Dapivirine Vaginal Ring Use Does Not Diminish the Effectiveness of Hormonal Contraception.

PubMed

Balkus, Jennifer E; Palanee-Phillips, Thesla; Reddy, Krishnaveni; Siva, Samantha; Harkoo, Ishana; Nakabiito, Clemensia; Kintu, Kenneth; Nair, Gonasangrie; Chappell, Catherine; Kiweewa, Flavia Matovu; Kabwigu, Samuel; Naidoo, Logashvari; Jeenarain, Nitesha; Marzinke, Mark; Soto-Torres, Lydia; Brown, Elizabeth R; Baeten, Jared M

2017-10-01

To evaluate the potential for a clinically relevant drug-drug interaction with concomitant use of a dapivirine vaginal ring, a novel antiretroviral-based HIV-1 prevention strategy, and hormonal contraception by examining contraceptive efficacies with and without dapivirine ring use. A secondary analysis of women participating in MTN-020/ASPIRE, a randomized, double-blind, placebo-controlled trial of the dapivirine vaginal ring for HIV-1 prevention. Use of a highly effective method of contraception was an eligibility criterion for study participation. Urine pregnancy tests were performed monthly. Pregnancy incidence by arm was calculated separately for each hormonal contraceptive method and compared using an Andersen-Gill proportional hazards model stratified by site and censored at HIV-1 infection. Of 2629 women enrolled, 2310 women returned for follow-up and reported using a hormonal contraceptive method at any point during study participation (1139 in the dapivirine arm and 1171 in the placebo arm). Pregnancy incidence in the dapivirine arm versus placebo among women using injectable depot medroxyprogesterone acetate was 0.43% vs. 0.54%, among women using injectable norethisterone enanthate was 1.15% vs. 0%, among women using hormonal implants was 0.22% vs. 0.69%, and among women using oral contraceptive pills was 32.26% vs. 28.01%. Pregnancy incidence did not differ by study arm for any of the hormonal contraceptive methods. Use of the dapivirine ring does not reduce the effectiveness of hormonal contraceptives for pregnancy prevention. Oral contraceptive pill use was associated with high pregnancy incidence, potentially because of poor pill adherence. Injectable and implantable methods were highly effective in preventing pregnancy.

Fine localization of the locus for autosomal dominant retinitis pigmentosa on chromosome 17p

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

Goliath, R.; Janssens, P.; Beighton, P.

1995-10-01

The term {open_quotes}retintis pigmentosa{close_quotes} (RP) refers to a group of inherited retinal degenerative disorders. Clinical manifestations include night-blindness, with variable age of onset, followed by constriction of the visual field that may progress to total loss of sight in later life. Previous studies have shown that RP is caused by mutations within different genes and may be inherited as an X-linked recessive (XLRRP), autosomal recessive (ARRP), or autosomal dominant (ADRP) trait. The AD form of this group of conditions has been found to be caused by mutations within the rhodopsin gene in some families and the peripherin/RDS gene in others.more » In addition, some ADRP families have been found to be linked to anonymous markers on 8cen, 7p, 7q,19q, and, more recently, 17p. The ADRP gene locus on the short arm of chromosome 17 was identified in a large South African family (ADRP-SA) of British origin. The phenotypic expression of the disorder, which has been described elsewhere is consistent in the pedigree with an early onset of disease symptoms. In all affected subjects in the family, onset of symptoms commenced before the age of 10 years. 16 refs., 3 figs., 1 tab.« less

Inertial constraints on limb proprioception are independent of visual calibration.

PubMed

Riley, M A; Turvey, M T

2001-04-01

When the coincidence of a limb's spatial axes and inertial eigenvectors is broken, haptic proprioception of the limb's position conforms to the eigenvectors. Additionally, when prisms break the coincidence between an arm's visual and actual positions, haptic proprioception is shifted toward the visual-spatial direction. In 3 experiments, variation of the arm's mass distribution was combined with prism adaptation to investigate the hypothesis that the proprioceptive effects of inertial and visual manipulations are additive. This hypothesis was supported across manipulations of plane of motion, body posture, proprioceptive target, and proprioceptive experience during prism adaptation. Haptic proprioception seems to depend on local, physical reference frames that are relative to the physical reference frames for the body's environmental position and orientation.

Use of malaria rapid diagnostic tests by community health workers in Afghanistan: cluster randomised trial.

PubMed

Leslie, Toby; Rowland, Mark; Mikhail, Amy; Cundill, Bonnie; Willey, Barbara; Alokozai, Asif; Mayan, Ismail; Hasanzai, Anwar; Baktash, Sayed Habibullah; Mohammed, Nader; Wood, Molly; Rahimi, Habib-U-Rahman; Laurent, Baptiste; Buhler, Cyril; Whitty, Christopher J M

2017-07-07

The World Health Organisation (WHO) recommends parasitological diagnosis of malaria before treatment, but use of malaria rapid diagnostic tests (mRDTs) by community health workers (CHWs) has not been fully tested within health services in south and central Asia. mRDTs could allow CHWs to diagnose malaria accurately, improving treatment of febrile illness. A cluster randomised trial in community health services was undertaken in Afghanistan. The primary outcome was the proportion of suspected malaria cases correctly treated for polymerase chain reaction (PCR)-confirmed malaria and PCR negative cases receiving no antimalarial drugs measured at the level of the patient. CHWs from 22 clusters (clinics) received standard training on clinical diagnosis and treatment of malaria; 11 clusters randomised to the intervention arm received additional training and were provided with mRDTs. CHWs enrolled cases of suspected malaria, and the mRDT results and treatments were compared to blind-read PCR diagnosis. In total, 256 CHWs enrolled 2400 patients with 2154 (89.8%) evaluated. In the intervention arm, 75.3% (828/1099) were treated appropriately vs. 17.5% (185/1055) in the control arm (cluster adjusted risk ratio: 3.72, 95% confidence interval 2.40-5.77; p < 0.001). In the control arm, 85.9% (164/191) with confirmed Plasmodium vivax received chloroquine compared to 45.1% (70/155) in the intervention arm (p < 0.001). Overuse of chloroquine in the control arm resulted in 87.6% (813/928) of those with no malaria (PCR negative) being treated vs. 10.0% (95/947) in the intervention arm, p < 0.001. In the intervention arm, 71.4% (30/42) of patients with P. falciparum did not receive artemisinin-based combination therapy, partly because operational sensitivity of the RDTs was low (53.2%, 38.1-67.9). There was high concordance between recorded RDT result and CHW prescription decisions: 826/950 (87.0%) with a negative test were not prescribed an antimalarial. Co-trimoxazole was prescribed to 62.7% of malaria negative patients in the intervention arm and 15.0% in the control arm. While introducing mRDT reduced overuse of antimalarials, this action came with risks that need to be considered before use at scale: an appreciable proportion of malaria cases will be missed by those using current mRDTs. Higher sensitivity tests could be used to detect all cases. Overtreatment with antimalarial drugs in the control arm was replaced with increased antibiotic prescription in the intervention arm, resulting in a probable overuse of antibiotics. ClinicalTrials.gov, NCT01403350 . Prospectively registered.

Effects of task-oriented robot training on arm function, activity, and quality of life in chronic stroke patients: a randomized controlled trial.

PubMed

Timmermans, Annick A A; Lemmens, Ryanne J M; Monfrance, Maurice; Geers, Richard P J; Bakx, Wilbert; Smeets, Rob J E M; Seelen, Henk A M

2014-03-31

Over fifty percent of stroke patients experience chronic arm hand performance problems, compromising independence in daily life activities and quality of life. Task-oriented training may improve arm hand performance after stroke, whereby augmented therapy may lead to a better treatment outcome. Technology-supported training holds opportunities for increasing training intensity. However, the effects of robot-supported task-oriented training with real life objects in stroke patients are not known to date. The aim of the present study was to investigate the effectiveness and added value of the Haptic Master robot combined with task-oriented arm hand training in chronic stroke patients. In a single-blind randomized controlled trial, 22 chronic stroke patients were randomly allocated to receive either task-oriented robot-assisted arm-hand training (experimental group) or task-oriented non-robotic arm-hand training (control group). For training, the T-TOAT (Technology-supported Task-Oriented Arm Training) method was applied. Training was provided during 8 weeks, 4 times/week, 2 × 30 min/day. A significant improvement after training on the Action Research Arm Test (ARAT) was demonstrated in the experimental group (p = 0.008). Results were maintained until 6 months after cessation of the training. On the perceived performance measure (Motor Activity Log (MAL)), both, the experimental and control group improved significantly after training (control group p = 0.008; experimental group p = 0.013). The improvements on MAL in both groups were maintained until 6 months after cessation of the training. With regard to quality of life, only in the control group a significant improvement after training was found (EuroQol-5D p = 0.015, SF-36 physical p = 0.01). However, the improvement on SF-36 in the control group was not maintained (p = 0.012). No between-group differences could be demonstrated on any of the outcome measures. Arm hand performance improved in chronic stroke patients, after eight weeks of task oriented training. The use of a Haptic Master robot in support of task-oriented arm training did not show additional value over the video-instructed task-oriented exercises in highly functional stroke patients. Current Controlled Trials ISRCTN82787126.

Strategies for understanding and reducing the Plasmodium vivax and Plasmodium ovale hypnozoite reservoir in Papua New Guinean children: a randomised placebo-controlled trial and mathematical model.

PubMed

Robinson, Leanne J; Wampfler, Rahel; Betuela, Inoni; Karl, Stephan; White, Michael T; Li Wai Suen, Connie S N; Hofmann, Natalie E; Kinboro, Benson; Waltmann, Andreea; Brewster, Jessica; Lorry, Lina; Tarongka, Nandao; Samol, Lornah; Silkey, Mariabeth; Bassat, Quique; Siba, Peter M; Schofield, Louis; Felger, Ingrid; Mueller, Ivo

2015-10-01

The undetectable hypnozoite reservoir for relapsing Plasmodium vivax and P. ovale malarias presents a major challenge for malaria control and elimination in endemic countries. This study aims to directly determine the contribution of relapses to the burden of P. vivax and P. ovale infection, illness, and transmission in Papua New Guinean children. From 17 August 2009 to 20 May 2010, 524 children aged 5-10 y from East Sepik Province in Papua New Guinea (PNG) participated in a randomised double-blind placebo-controlled trial of blood- plus liver-stage drugs (chloroquine [CQ], 3 d; artemether-lumefantrine [AL], 3 d; and primaquine [PQ], 20 d, 10 mg/kg total dose) (261 children) or blood-stage drugs only (CQ, 3 d; AL, 3 d; and placebo [PL], 20 d) (263 children). Participants, study staff, and investigators were blinded to the treatment allocation. Twenty children were excluded during the treatment phase (PQ arm: 14, PL arm: 6), and 504 were followed actively for 9 mo. During the follow-up time, 18 children (PQ arm: 7, PL arm: 11) were lost to follow-up. Main primary and secondary outcome measures were time to first P. vivax infection (by qPCR), time to first clinical episode, force of infection, gametocyte positivity, and time to first P. ovale infection (by PCR). A basic stochastic transmission model was developed to estimate the potential effect of mass drug administration (MDA) for the prevention of recurrent P. vivax infections. Targeting hypnozoites through PQ treatment reduced the risk of having at least one qPCR-detectable P. vivax or P. ovale infection during 8 mo of follow-up (P. vivax: PQ arm 0.63/y versus PL arm 2.62/y, HR = 0.18 [95% CI 0.14, 0.25], p < 0.001; P. ovale: 0.06 versus 0.14, HR = 0.31 [95% CI 0.13, 0.77], p = 0.011) and the risk of having at least one clinical P. vivax episode (HR = 0.25 [95% CI 0.11, 0.61], p = 0.002). PQ also reduced the molecular force of P. vivax blood-stage infection in the first 3 mo of follow-up (PQ arm 1.90/y versus PL arm 7.75/y, incidence rate ratio [IRR] = 0.21 [95% CI 0.15, 0.28], p < 0.001). Children who received PQ were less likely to carry P. vivax gametocytes (IRR = 0.27 [95% CI 0.19, 0.38], p < 0.001). PQ had a comparable effect irrespective of the presence of P. vivax blood-stage infection at the time of treatment (p = 0.14). Modelling revealed that mass screening and treatment with highly sensitive quantitative real-time PCR, or MDA with blood-stage treatment alone, would have only a transient effect on P. vivax transmission levels, while MDA that includes liver-stage treatment is predicted to be a highly effective strategy for P. vivax elimination. The inclusion of a directly observed 20-d treatment regime maximises the efficiency of hypnozoite clearance but limits the generalisability of results to real-world MDA programmes. These results suggest that relapses cause approximately four of every five P. vivax infections and at least three of every five P. ovale infections in PNG children and are important in sustaining transmission. MDA campaigns combining blood- and liver-stage treatment are predicted to be a highly efficacious intervention for reducing P. vivax and P. ovale transmission. ClinicalTrials.gov NCT02143934.

20 CFR 416.1720 - Whom we refer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Whom we refer. 416.1720 Section 416.1720 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Referral of Persons Eligible for Supplemental Security Income to Other Agencies Referral for Treatment of Alcoholism Or Drug Addiction § 41...

20 CFR 416.1710 - Whom we refer and when.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Whom we refer and when. 416.1710 Section 416.1710 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Referral of Persons Eligible for Supplemental Security Income to Other Agencies Referral for Vocational Rehabilitation Services §...

Validation of the Medisana MTP Plus upper arm blood pressure monitor, for self-measurement, according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Erdem, Emre; Aydogdu, Türkan; Akpolat, Tekin

2011-02-01

Standard validation protocols are objective guides for healthcare providers, physicians, and patients. The purpose of this study was to test validation of the Medisana MTP Plus upper arm blood pressure (BP) measuring monitor for self-measurement according to the European Society of Hypertension International Protocol (ESH-IP2) in adults. The Medisana MTP Plus monitor is an automated and oscillometric upper arm device for home BP monitoring. Nine consecutive measurements were made according to the ESH-IP2. Overseen by an independent supervisor, measurements were recorded by two observers blinded from both each other's readings and from the device readings. The Medisana MTP Plus device fulfills the validation criteria of the ESH-IP2 for the general population. The mean (standard deviation) of the difference between the observers and the device measurements was 0.6 mmHg (5.1 mmHg) for systolic and 2.7 mmHg (3.4 mmHg) for diastolic pressures, respectively. As the Medisana MTP Plus device has achieved the required standards, it is recommended for home BP monitoring in an adult population.

Probiotics for standard triple Helicobacter pylori eradication: a randomized, double-blind, placebo-controlled trial.

PubMed

Hauser, Goran; Salkic, Nermin; Vukelic, Karina; JajacKnez, Alenka; Stimac, Davor

2015-05-01

The primary objective in the study is determination of efficacy of probiotic preparation as a supportive therapy in eradication of Helicobacter pylori.The study was multicenter, prospective, randomized, placebo controlled, and double-blind. The subjects first filled out a specially designed questionnaire to assess the severity of the 10 symptoms, which can be related to eradication therapy to be monitored during the trial. Each subject then received 28 capsules of probiotic preparation or matching placebo capsules, which they were supposed to take over the following 14 days, twice a day, at least 2 hours prior to or after the antibiotic therapy administration.A total of 804 patients were enrolled in the trial, of which 650 (80.85%) were included in the analysis. The results show a significantly larger share of cured subjects in the probiotic arm versus the placebo arm (87.38% vs 72.55%; P < 0.001). Additionally, presence and intensity of epigastric pain, bloating, flatulence, taste disturbance, loss of appetite, nausea, vomiting, heartburn, rash, and diarrhea were monitored over the study period. At 15 days postinclusion, probiotic treatment was found superior to placebo in 7 of 10 mentioned symptoms. Average intensity for symptoms potentially related to antibiotic therapy was significantly higher in the placebo group, 0.76 vs 0.55 (P < 0.001).Adding probiotics to the standard triple therapy for H pylori eradication significantly contributes to treatment efficacy and distinctly decreases the adverse effects of therapy and the symptoms of the underlying disease.

Virtual temporal bone dissection system: OSU virtual temporal bone system: development and testing.

PubMed

Wiet, Gregory J; Stredney, Don; Kerwin, Thomas; Hittle, Bradley; Fernandez, Soledad A; Abdel-Rasoul, Mahmoud; Welling, D Bradley

2012-03-01

The objective of this project was to develop a virtual temporal bone dissection system that would provide an enhanced educational experience for the training of otologic surgeons. A randomized, controlled, multi-institutional, single-blinded validation study. The project encompassed four areas of emphasis: structural data acquisition, integration of the system, dissemination of the system, and validation. Structural acquisition was performed on multiple imaging platforms. Integration achieved a cost-effective system. Dissemination was achieved on different levels including casual interest, downloading of software, and full involvement in development and validation studies. A validation study was performed at eight different training institutions across the country using a two-arm randomized trial where study subjects were randomized to a 2-week practice session using either the virtual temporal bone or standard cadaveric temporal bones. Eighty subjects were enrolled and randomized to one of the two treatment arms; 65 completed the study. There was no difference between the two groups using a blinded rating tool to assess performance after training. A virtual temporal bone dissection system has been developed and compared to cadaveric temporal bones for practice using a multicenter trial. There was no statistical difference between practice on the current simulator compared to practice on human cadaveric temporal bones. Further refinements in structural acquisition and interface design have been identified, which can be implemented prior to full incorporation into training programs and used for objective skills assessment. Copyright © 2012 The American Laryngological, Rhinological, and Otological Society, Inc.

Neurologic signs and symptoms in fibromyalgia.

PubMed

Watson, Nathaniel F; Buchwald, Dedra; Goldberg, Jack; Noonan, Carolyn; Ellenbogen, Richard G

2009-09-01

To determine the type and frequency of neurologic signs and symptoms in individuals with fibromyalgia (FM). Persons with FM (n = 166) and pain-free controls (n = 66) underwent systematic neurologic examination by a neurologist blinded to disease status. Neurologic symptoms lasting at least 3 months were assessed with a standard questionnaire. We used logistic regression to evaluate the association of neurologic symptoms and examination findings with FM status. Within the FM group we examined the correlation between self-reported symptoms and physical examination findings. Age- and sex-adjusted estimates revealed that compared with the control group, the FM group had significantly more neurologic abnormalities in multiple categories, including greater dysfunction in cranial nerves IX and X (42% versus 8%) and more sensory (65% versus 25%), motor (33% versus 3%), and gait (28% versus 7%) abnormalities. Similarly, the FM group had significantly more neurologic symptoms than the control group in 27 of 29 categories, with the greatest differences observed for photophobia (70% versus 6%), poor balance (63% versus 4%), and weakness (58% versus 2%) and tingling (54% versus 4%) in the arms or legs. Poor balance or coordination, tingling or weakness in the arms or legs, and numbness in any part of the body correlated with appropriate neurologic examination findings in the FM group. This blinded, controlled study demonstrated neurologic physical examination findings in persons with FM. The FM group had more neurologic symptoms than did the controls, with moderate correlation between symptoms and signs. These findings have implications for the medical evaluation of patients with FM.

Neurological Signs and Symptoms in Fibromyalgia

PubMed Central

Watson, Nathaniel F.; Buchwald, Dedra; Goldberg, Jack; Noonan, Carolyn; Ellenbogen, Richard G.

2009-01-01

Objective To determine the type and frequency of neurological signs and symptoms in individuals with fibromyalgia (FM). Methods Persons with FM (n=166) and pain-free controls (n=66) underwent systematic neurological examination by a neurologist blinded to disease status. Neurological symptoms present over the preceding 3 months were assessed with a standard questionnaire. We used logistic regression to evaluate the association of neurological symptoms and examination findings with FM status. Within the FM group we examined the correlation between self-reported symptoms and physical examination findings. Results Compared to the control group, age and gender adjusted estimates revealed the FM group had significantly more neurological abnormalities in multiple categories including: cranial nerves IX and X (42% vs. 8%), sensory (65% vs. 25%), motor (33% vs. 3%), and gait (28% vs. 7%). Similarly, the FM group endorsed significantly more neurological symptoms than the control group in 27 of 29 categories with the biggest differences observed for photophobia (70% vs. 6%), poor balance (63% vs. 4%), and weakness (58% vs. 2%) and tingling (54% vs. 4%) in the arms and legs. Poor balance, coordination, tingling, weakness in the arms and legs, and numbness in any part of body correlated with appropriate neurological exam findings in the FM group. Conclusions This blinded, controlled study demonstrated neurological physical examination findings in persons with FM. The FM group had more neurological symptoms than controls, with moderate correlation between symptoms and signs. These findings have implications for the medical work-up of patients with FM. PMID:19714636

Dual energy X-ray absorptiometry body composition reference values of limbs and trunk from NHANES 1999–2004 with additional visualization methods

PubMed Central

Fan, Bo; Ng, Bennett K.; Shepherd, John A.

2017-01-01

Body Mass Index has traditionally been used as a measure of health, but Fat Mass Index (FMI) and Lean Mass Index (LMI) have been shown to be more predictive of mortality and health risk. Total body FMI and LMI reference curves have particularly been useful in quantifying sarcopenia and sarcopenic obesity. Research has shown regional composition has significant associations to health outcomes. We derived FMI and LMI reference curves of the regions of the body (leg, arm, and trunk) for 15,908 individuals in the 1999–2004 National Health and Nutrition Examination Survey data for each sex and ethnicity using the Lambda-Mu-Sigma (LMS) method and developed software to visualize this regional composition. These reference curves displayed differentiation between males and females during puberty and sharper limb LMI declines during late adulthood for males. For adults ages 30–50, females had 39%, 83%, and 47% larger arm, leg, and trunk FMI values than males, respectively. Males had 49%, 20%, and 15% higher regional LMI values than females for the arms, legs, and trunk respectively. The leg FMI and LMI of black females were 14% and 15% higher respectively than those of Hispanic and white females. White and Hispanic males had 37% higher trunk FMI values than black males. Hispanic females had 20% higher trunk FMI than white and black females. These data underscore the importance of accounting for sex and ethnicity in studies of regional composition. This study is the first to produce regional LMI and FMI reference tables and curves from the NHANES dataset. These reference curves provide a framework useful in studies and research involving sarcopenia, obesity, sarcopenic obesity, and other studies of compositional phenotypes. Further, the software tool we provide for visualizing regional composition will prove useful in monitoring progress in physical therapy, diets, or other attempts to attain healthier compositions. PMID:28346492

Arms Transfers to the Irish Republican Army.

DTIC Science & Technology

1987-06-01

Land and Liberty Grupo de Resistencia Antifascista Primo de Octubre - First of October Anti-Facist Resistance Group Guerrilleros Del Cristo Rey...been freed by "inexplicable" court decisions to be placed on trial. This was seen here (Dublin] as a reference to the case of seven men, allegedly...members of the illegal Irish Republican Army, who appeared before a court at Dundalk on arms-smuggling charges last week. The charges were iismissei because

A bill to require a Comptroller General of the United States report on the impact of certain mental and physical trauma on the discharge of members of the Armed Forces for misconduct.

THOMAS, 113th Congress

Sen. Bennet, Michael F. [D-CO

2013-11-07

Senate - 11/07/2013 Read twice and referred to the Committee on Armed Services. (All Actions) Notes: For further action, see H.R.3979, which became Public Law 113-291 on 12/19/2014. Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Skylab rescue space vehicle flight readiness test

NASA Technical Reports Server (NTRS)

Jevitt, S. J.

1973-01-01

A Skylab Rescue Space Vehicle flight readiness test is described which ensures that space vehicle systems are in a state of flight readiness and are compatible with associated ground support equipment. The functions of propellant loading, umbilical ejection, ignition, holddown arm release, liftoff, and service arm and tail service mast retraction are simulated. The test outline is presented along with a list of references, intercommunications information, operations interface control chart, and flight test.

A double-blind, randomized clinical trial of dietary supplementation on cognitive and immune functioning in healthy older adults.

PubMed

Lewis, John E; Melillo, Angelica B; Tiozzo, Eduard; Chen, Lawrence; Leonard, Susanna; Howell, Mark; Diaz, Janelle; Gonzalez, Kathy; Woolger, Judi M; Konefal, Janet; Paterson, Elaine; Barnes, David

2014-02-04

Declining cognitive function is relatively common and increasingly prevalent. Studies have shown that different nutrients (e.g., Ginkgo biloba and vitamin E) appear to be effective at improving memory and concentration, while less is known about their effect on immunity. This study investigated the effect of Ginkgo Synergy(®) plus Choline (n = 33) and OPC Synergy(®) plus Catalyn(®) (n = 31) versus placebo (n = 33) in a 6-month, randomized, double-blind trial on cognitive and immune functioning among English-speaking, non-smoking, healthy older adults. The Stroop Color and Word Test, Trail Making Test A and B, Controlled Oral Word Association, Hopkins Verbal Learning, Mini-Mental State Exam, and Digit Symbol were administered at baseline and 3 and 6 months follow-up to assess cognitive functioning. Cytokines and growth factors were measured at baseline and 6 months to assess inflammation and immune functioning. Data were analyzed with linear mixed modeling. No serious adverse events were noted in this study. According to time on the Trail Making Test-B, the Ginkgo Synergy(®) plus Choline arm showed improvement from baseline to 3 months follow-up (mean difference = 24.2; SE = 6.4; 95% CI: 8.6, 39.7; p = 0.01). On the Controlled Oral Word Association Trial-S, the scores significantly increased for the Ginkgo Synergy(®) plus Choline arm from baseline to 6 months follow-up (mean difference = 2.1; SE = 0.8; 95% CI: 0.2, 3.9; p < 0.05) and for the OPC Synergy(®) plus Catalyn(®) arm from baseline to 3 months follow-up (mean difference = 2.1; SE = 0.8; 95% CI: 0.2, 4.0; p < 0.05). Epidermal growth factor significantly decreased from baseline to 6 months follow-up for the Ginkgo Synergy(®) plus Choline arm (mean difference = 120.7; SE = 28.4; 95% CI: 62.6, 178.8; p < 0.001). Our study showed isolated and modest effects of a Ginkgo biloba plus choline-based formula on cognitive and immune functioning among healthy older adults with no history of significant cognitive deficits. Our trial was registered with clinicaltrials.gov (ID: NCT01672359). This study was supported by a grant from Standard Process, Inc.

Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE): a randomized controlled trial protocol.

PubMed

Winstein, Carolee J; Wolf, Steven L; Dromerick, Alexander W; Lane, Christianne J; Nelsen, Monica A; Lewthwaite, Rebecca; Blanton, Sarah; Scott, Charro; Reiss, Aimee; Cen, Steven Yong; Holley, Rahsaan; Azen, Stanley P

2013-01-11

Residual disability after stroke is substantial; 65% of patients at 6 months are unable to incorporate the impaired upper extremity into daily activities. Task-oriented training programs are rapidly being adopted into clinical practice. In the absence of any consensus on the essential elements or dose of task-specific training, an urgent need exists for a well-designed trial to determine the effectiveness of a specific multidimensional task-based program governed by a comprehensive set of evidence-based principles. The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) Stroke Initiative is a parallel group, three-arm, single blind, superiority randomized controlled trial of a theoretically-defensible, upper extremity rehabilitation program provided in the outpatient setting.The primary objective of ICARE is to determine if there is a greater improvement in arm and hand recovery one year after randomization in participants receiving a structured training program termed Accelerated Skill Acquisition Program (ASAP), compared to participants receiving usual and customary therapy of an equivalent dose (DEUCC). Two secondary objectives are to compare ASAP to a true (active monitoring only) usual and customary (UCC) therapy group and to compare DEUCC and UCC. Following baseline assessment, participants are randomized by site, stratified for stroke duration and motor severity. 360 adults will be randomized, 14 to 106 days following ischemic or hemorrhagic stroke onset, with mild to moderate upper extremity impairment, recruited at sites in Atlanta, Los Angeles and Washington, D.C. The Wolf Motor Function Test (WMFT) time score is the primary outcome at 1 year post-randomization. The Stroke Impact Scale (SIS) hand domain is a secondary outcome measure.The design includes concealed allocation during recruitment, screening and baseline, blinded outcome assessment and intention to treat analyses. Our primary hypothesis is that the improvement in log-transformed WMFT time will be greater for the ASAP than the DEUCC group. This pre-planned hypothesis will be tested at a significance level of 0.05. ICARE will test whether ASAP is superior to the same number of hours of usual therapy. Pre-specified secondary analyses will test whether 30 hours of usual therapy is superior to current usual and customary therapy not controlled for dose. www.ClinicalTrials.gov Identifier: NCT00871715

DupuytrEn Treatment EffeCtiveness Trial (DETECT): a protocol for prospective, randomised, controlled, outcome assessor-blinded, three-armed parallel 1:1:1, multicentre trial comparing the effectiveness and cost of collagenase clostridium histolyticum, percutaneous needle fasciotomy and limited fasciectomy as short-term and long-term treatment strategies in Dupuytren's contracture.

PubMed

Räisänen, Mikko P; Karjalainen, Teemu; Göransson, Harry; Reito, Aleksi; Kautiainen, Hannu; Malmivaara, Antti; Leppänen, Olli V

2018-03-28

Dupuytren's contracture (DC) is a chronic fibroproliferative disorder of the palmar fascia which leads to flexion contracture in one or more fingers. There is no definitive cure for DC, and treatment aims at relieving symptoms by releasing the contracture using percutaneous or operative techniques. We planned a prospective, randomised, controlled, outcome assessor-blinded, three-armed parallel 1:1:1, multicentre trial comparing the effectiveness and cost of (1) collagenase clostridium histolyticum injection followed by limited fasciectomy in non-responsive cases, (2) percutaneous needle fasciotomy followed by limited fasciectomy in non-responsive cases and (3) primary limited fasciectomy during short-term and long-term follow-up for Tubiana I-III stages DC. We will recruit participants from seven national centres in Finland. Primary outcome is the rate of success in the treatment arm at 5 years after recruitment. Success is a composite outcome comprising (1) at least 50% contracture release from the date of recruitment and (2) participants in a patient-accepted symptom state (PASS). Secondary outcomes are (1) angle of contracture, (2) quick disabilities of the arm, a shoulder and hand outcome measure (QuickDASH), (3) perceived hand function, (4) EQ-5D-3L, (5) rate of major adverse events, (6) patient's trust of the treatment, (7) global rating, (8) rate of PASS, (9) rate of minimal clinically important improvement, (10) expenses, (11) progression of disease, (12) progression-free survival, (13) favoured treatment modality, (14) patients achieving full contracture release and >50% improvement and (15) patient satisfaction with the treatment effect. Predictive factors for achieving the PASS will also be analysed. The protocol was approved by the Tampere University Hospital Institutional Review Board and Finnish Medicine Agency. The study will be performed according to the principles of good clinical practice. The results of the trial will be disseminated as published articles in peer-reviewed journals. NCT03192020; 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.

A cluster randomised controlled trial evaluating the effectiveness of a structured pulmonary rehabilitation education programme for improving the health status of people with chronic obstructive pulmonary disease (COPD): The PRINCE Study protocol.

PubMed

Murphy, Kathy; Casey, Dympna; Devane, Declan; Cooney, Adeline; McCarthy, Bernard; Mee, Lorraine; Nichulain, Martina; Murphy, Andrew W; Newell, John; O' Shea, Eamon

2011-01-18

A key strategy in improving care for people with chronic obstructive pulmonary disease (COPD) is the provision of pulmonary rehabilitation programmes. Pulmonary rehabilitation programmes have been successful in improving patients' sense of dyspnoea and Health Related Quality of Life. However, the effectiveness of structured education pulmonary rehabilitation programmes delivered at the level of the general practice on the health status of people with COPD remains uncertain and there is a need for a robust and fair assessment of this. The PRINCE study will evaluate the effectiveness of a Structured Education Pulmonary Rehabilitation Programme (SEPRP), delivered at the level of the general practice, on the health status of people with COPD. The PRINCE Trial is a two-armed, single blind cluster randomised trial conducted in the primary care setting in Ireland. Randomisation to control and intervention is at the level of the General Practice. Participants in the intervention arm will receive a SEPRP and those allocated to the control arm will receive usual care. Delivery of the SEPRP will be by a practice nurse and physiotherapist in the General Practice (GP) site. The primary outcome measure of the study will be health status as measured by the Chronic Respiratory Questionnaire (CRQ). Blinded outcome assessment will be undertaken at baseline and at twelve-fourteen weeks after completion of the programme. A comparison of outcomes between the intervention and control sites will be made to examine if differences exist and, if so, to what extent between control and experimental groups. Sample size calculations estimate that 32 practices with a minimum of 10 participants per practice are required, in total, to be randomised to control and intervention arms for power of at least 80% with alpha levels of 0.05, to determine a clinically significant change of 0.5 units in the CRQ. A cost effectiveness analysis will also be conducted. The results of this trial are directly applicable to primary care settings in Ireland. Should a SEPRP delivered by practice nurses and physiotherapists in primary care be found to be effective in improving patients' sense of dyspnoea and HRQoL, then the findings would be applicable to many thousands of individuals in Ireland and beyond.

Comparison of two protocols for the management of asymptomatic postmenopausal women with adnexal tumours - a randomised controlled trial of RMI/RCOG vs Simple Rules.

PubMed

Nunes, Natalie; Ambler, Gareth; Foo, Xulin; Naftalin, Joel; Derdelis, Grigoris; Widschwendter, Martin; Jurkovic, Davor

2017-02-28

Adnexal tumours are frequently diagnosed in asymptomatic postmenopausal women due to more liberal use of modern high-resolution imaging. This study's objective was to determine if there would be a difference in the intervention rates when using the Simple Rules Management Protocol (SRMP) as compared to the Risk of Malignancy Index in the Royal College of Obstetricians and Gynaecologists guideline (RMI/RCOG). This was a prospective randomised controlled trial with the participants and the researchers non-blinded, and the surgeons and pathologists blinded. We recruited pain-free postmenopausal women who were diagnosed with an adnexal tumour on ultrasound scan. Women were randomised to either of the two protocols, which then determined if they were offered conservative or surgical management. An intention-to-treat analysis was performed. The primary outcome measure was rate of surgical interventions for ovarian cysts up to 12 months after randomisation. The secondary outcome measures were the number of staging surgical procedures, surgical complications and number of delayed diagnoses of ovarian cancer. A total of 148 women were randomised over 39 months with 73 in the RMI/RCOG arm and 75 in the SRMP arm with outcome data for 136 at 12 months. The two groups were balanced in terms of age, length of time since menopause and use of hormone replacement therapy. There were 18 out of 68 (28.1%) women in the RMI/RCOG arm who had surgery vs 7 out of 68 (10.3%) women in the SRMP arm (P=0.015, χ 2 -test). The difference in these proportions was 16.2% (95% confidence interval (CI): 3.4-28.9%) and the relative risk was 2.57 (95% CI: 1.15-5.76). There were no significant differences in the number of staging surgical procedures and the surgical complications between the two groups and there were no delayed diagnoses of ovarian cancer at 12 months. Surgical intervention rates in asymptomatic postmenopausal women with an ultrasound diagnosis of adnexal tumours are significantly lower when the novel SRMP protocol is used for triaging compared to the standard RMI/RCOG protocol without an increase in delayed malignant diagnoses.

Face transplantation for the blind: more than being blind in a sighted world.

PubMed

Lee, Joseph

2018-06-01

Face transplantation (FT) is a landmark in reconstructive surgery involving vascularised composite allotransplantation. A recent issue of FT for patients who are blind has arisen. Some bioethicists recommend not excluding a patient who is blind, as this may amount to discrimination. From an ethical standpoint, FT for those with blindness is appropriate in selected candidates. This article seeks to add to the clinical evidence supporting FT for those with blindness by detailing a complementary psychosocial perspective. Currently, there is little relevant research about the subjectivity of the blind. This is critical since the arguments against FT for the blind refer to their inability to see their face and to view the reaction of others to their disfigured faces. We begin with a brief look at examples of FT involving blindness and associated arguments. The next part is a multidisciplinary investigation of the experiences of the blind. These are gleaned from a close reading of the literature and drawing inferences, as direct studies are rare. The discussion analyses identity themes of the blind in relation to their faces: as they experience it; the face they wish to show to the world; and how others perceive and react to their face in a saturated environment of imagery and visual communication. Disability and the blind person's experience of faces are well-founded considerations for medical practitioners and ethics boards in the process of FT decision-making. © 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.

Evaluation of intralesional injection of hyaluronic acid compared with verapamil in Peyronie's disease: preliminary results from a prospective, double-blinded, randomized study.

PubMed

Favilla, V; Russo, G I; Zucchi, A; Siracusa, G; Privitera, S; Cimino, S; Madonia, M; Cai, T; Cavallini, G; Liguori, G; D'Achille, G; Silvani, M; Franco, G; Verze, P; Palmieri, A; Torrisi, B; Mirone, V; Morgia, G

2017-07-01

Several intralesional therapeutic protocols have been proposed for the treatment of Peyronie's disease. Among all, hyaluronic acid (HA) and verapamil have been differently tested. We aimed to evaluate the efficacy of intralesional verapamil (ILVI) compared with intralesional HA in patients with early onset of Peyronie's disease (PD). This is a multi-centre prospective double-arm, randomized, double-blinded study comparing ILVI vs. intralesional HA after 12-weeks. Sexually active men, older than 18 years and affected by the acute phase of PD were eligible for this study. Patients have been double-blinded randomly divided into two groups (1 : 1 ratio): Group A received intralesional treatment with Verapamil (10 mg in 5 mL of normal saline water) weekly for 12 weeks, while group B received intralesional treatment with HA (0.8% highly purified sodium salt HA 16 mg/2 mL) weekly for 12 weeks. The primary efficacy outcome was the change from the baseline to the endpoint (12 weeks after therapy) for the penile curvature (degree). The secondary outcome was the change in the plaque size and in the International Index of erectile Function (IIEF-5) score. The difference between post- and pre-treatment plaque size was -1.36 mm (SD ± 1.27) for Group A and -1.80 mm (SD ± 2.47) for Group B (p-value = NS). IIEF-5 increased of 1.46 points (SD ± 2.18) in Group A and 1.78 (SD ± 2.48) in Group B (p-value ± NS). No difference in penile curvature was observed in Group A, while in Group B the penile curvature decreased of 4.60° (SD ± 5.63) from the baseline (p < 0.001) and vs. Group A. According to PGI-I results, we found significant difference as concerning patient global impression of improvement (PGI-I) (4.0 vs. 2.0; p < 0.05). This prospective, double-arm, randomized, double-blinded study comparing ILVI vs. HA as intralesional therapy showed greater efficacy of HA in terms of penile curvature and PGI-I. © 2017 American Society of Andrology and European Academy of Andrology.

U.S. Food and Drug Administration Approval Summary: Enzalutamide for the Treatment of Patients With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer.

PubMed

Ning, Yang-Min; Brave, Michael; Maher, V Ellen; Zhang, Lijun; Tang, Shenghui; Sridhara, Rajeshwari; Kim, Geoffrey; Ibrahim, Amna; Pazdur, Richard

2015-08-01

The U.S. Food and Drug Administration approved enzalutamide for the treatment of patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC). At the prespecified interim analysis, a statistically significant improvement in overall survival was demonstrated for patients in the enzalutamide arm compared with patients in the placebo arm. The overall benefit-risk profile supports the expanded indication for enzalutamide. On September 10, 2014, the U.S. Food and Drug Administration approved enzalutamide for the treatment of patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC). Enzalutamide was initially approved in 2012 for use in patients with mCRPC who had previously received docetaxel. The current approval was based on the results of a randomized, placebo-controlled, double-blind trial conducted in 1,717 asymptomatic or minimally symptomatic patients with chemotherapy-naïve mCRPC. Patients were assigned to receive either enzalutamide 160 mg or placebo orally once daily. The coprimary endpoints were overall survival (OS) and radiographic progression-free survival (rPFS), which was assessed by independent central radiology review. At the prespecified interim analysis, a statistically significant improvement in OS was demonstrated for patients in the enzalutamide arm compared with patients in the placebo arm (hazard ratio [HR], 0.71; 95% confidence interval [CI], 0.60-0.84). The median OS was 32.4 and 30.2 months in the enzalutamide and placebo arms, respectively. A statistically significant prolongation of rPFS was observed in patients in the enzalutamide arm (HR, 0.17; 95% CI, 0.14-0.21). In addition, the time to initiation of cytotoxic chemotherapy was prolonged in the enzalutamide arm (HR, 0.35; 95% CI, 0.30-0.40), with median times of 28.0 and 10.8 months in the enzalutamide and placebo arms, respectively. The safety profile was similar to that previously reported for enzalutamide. Adverse reactions of interest included seizure, hypertension, and falls. Enzalutamide should be discontinued if a seizure occurs during treatment. The overall benefit-risk profile supports the expanded indication for enzalutamide. ©AlphaMed Press.

Reach-to-grasp movement as a minimization process.

PubMed

Yang, Fang; Feldman, Anatol G

2010-02-01

It is known that hand transport and grasping are functionally different but spatially coordinated components of reach-to-grasp (RTG) movements. As an extension of this notion, we suggested that body segments involved in RTG movements are controlled as a coherent ensemble by a global minimization process associated with the necessity for the hand to reach the motor goal. Different RTG components emerge following this process without pre-programming. Specifically, the minimization process may result from the tendency of neuromuscular elements to diminish the spatial gap between the actual arm-hand configuration and its virtual (referent) configuration specified by the brain. The referent configuration is specified depending on the object shape, localization, and orientation. Since the minimization process is gradual, it can be interrupted and resumed following mechanical perturbations, at any phase during RTG movements, including hand closure. To test this prediction of the minimization hypothesis, we asked subjects to reach and grasp a cube placed within the reach of the arm. Vision was prevented during movement until the hand returned to its initial position. As predicted, by arresting wrist motion at different points of hand transport in randomly selected trials, it was possible to halt changes in hand aperture at any phase, not only during hand opening but also during hand closure. Aperture changes resumed soon after the wrist was released. Another test of the minimization hypothesis was made in RTG movements to an object placed beyond the reach of the arm. It has previously been shown (Rossi et al. in J Physiol 538:659-671, 2002) that in such movements, the trunk motion begins to contribute to hand transport only after a critical phase when the shifts in the referent arm configuration have finished (at about the time when hand velocity is maximal). The minimization rule suggests that when the virtual contribution of the arm to hand transport is completed, guidance of hand aperture switches from the arm to the trunk control system. As a consequence, hand aperture changes can be halted by trunk arrests but only if they are prolonged beyond a critical phase. As predicted, hand transport and hand aperture in RTG movements beyond the reach of the arm were halted by trunk arrests only if they were prolonged beyond the time of peak hand velocity. Hand motion and aperture changes resumed only when the trunk was released. While supporting the minimization hypothesis, our findings imply that not only spatial but also temporal characteristics of each component, including the shortest, hand closure component of RTG movements, are controlled in a flexible, task-specific way.

Memory impairment is not sufficient for choice blindness to occur.

PubMed

Sagana, Anna; Sauerland, Melanie; Merckelbach, Harald

2014-01-01

Choice blindness refers to the phenomenon that people can be easily misled about the choices they made in the recent past. The aim of this study was to explore the cognitive mechanisms underlying choice blindness. Specifically, we tested whether memory impairment may account for choice blindness. A total of N = 88 participants provided sympathy ratings on 10-point scales for 20 female faces. Subsequently, participants motivated some of their ratings. However, on three trials, they were presented with sympathy ratings that deviated from their original ratings by three full scale points. On nearly 41% of the trials, participants failed to detect (i.e., were blind) the manipulation. After a short interval, participants were informed that some trials had been manipulated and were asked to recall their original ratings. Participants adopted the manipulated outcome in only 3% of the trials. Furthermore, the extent to which the original ratings were accurately remembered was not higher for detected as compared with non-detected trials. From a theoretical point of view our findings indicate that memory impairment does not fully account for blindness phenomena.

Memory impairment is not sufficient for choice blindness to occur

PubMed Central

Sagana, Anna; Sauerland, Melanie; Merckelbach, Harald

2014-01-01

Choice blindness refers to the phenomenon that people can be easily misled about the choices they made in the recent past. The aim of this study was to explore the cognitive mechanisms underlying choice blindness. Specifically, we tested whether memory impairment may account for choice blindness. A total of N = 88 participants provided sympathy ratings on 10-point scales for 20 female faces. Subsequently, participants motivated some of their ratings. However, on three trials, they were presented with sympathy ratings that deviated from their original ratings by three full scale points. On nearly 41% of the trials, participants failed to detect (i.e., were blind) the manipulation. After a short interval, participants were informed that some trials had been manipulated and were asked to recall their original ratings. Participants adopted the manipulated outcome in only 3% of the trials. Furthermore, the extent to which the original ratings were accurately remembered was not higher for detected as compared with non-detected trials. From a theoretical point of view our findings indicate that memory impairment does not fully account for blindness phenomena. PMID:24904467

Case of paracentric inversion 19p

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

Bettio, D.; Rizzi, N.; Giardino, D.

Paracentric inversions have been described less frequently than pericentric ones. It is not known whether this is due to their rarity or rather to difficulty in detecting intra-arm rearrangements. Paracentric inversions have been noted in all chromosomes except chromosome 19; the short arm was involved in 21 cases and the long arm in 87. We describe the first case of paracentric inversion in chromosome 19. The patient, a 29-year-old man, was referred for cytogenetic investigation because his wife had had 3 spontaneous abortions. No history of subfertility was recorded. Chromosome studies on peripheral blood lymphocytes demonstrated an abnormal QFQ bandingmore » pattern in the short arm of one chromosome 19. The comparison between QFQ, GTG and RBA banding led us to suspect a paracentric inversion involving the chromosome 19 short arm. CBG banding resulted in an apparently normal position of the centromere. Parental chromosome studies showed the same anomaly in the patient`s mother. 4 refs.« less

Cold Gas Content and Morphology: Scaling Relationships and Gas Deficiencies

NASA Astrophysics Data System (ADS)

Zhang, Helen; Crocker, Alison

2018-01-01

Spiral arms are a key feature of spiral galaxies. They are areas of higher gas density, and thus more stars are actively being formed in these regions. Two armed spirals are commonly referred to as ‘grand design’ spirals. In constrast, many armed spirals have three or more arms that are often less distinct. Here we present the cold gas mass per unit of stellar mass (cold gas fraction) in grand design spirals versus many armed spiral galaxies using Galaxy Zoo 2 for our morphological classifications. The masses of HI and H2 gas are taken from the COLDGASS survey, which included nondetections in the form of upper limits. Through our analysis, we found that grand design galaxies have a lower cold gas fraction of both HI and H2. This is a surprising result, given that earlier studies have shown that they have comparable rates of star formation. Combined with our result, this means that grand design galaxies must be more efficient at converting H2 gas to stars.

Developmental vision determines the reference frame for the multisensory control of action.

PubMed

Röder, Brigitte; Kusmierek, Anna; Spence, Charles; Schicke, Tobias

2007-03-13

Both animal and human studies suggest that action goals are defined in external coordinates regardless of their sensory modality. The present study used an auditory-manual task to test whether the default use of such an external reference frame is innately determined or instead acquired during development because of the increasing dominance of vision over manual control. In Experiment I, congenitally blind, late blind, and age-matched sighted adults had to press a left or right response key depending on the bandwidth of pink noise bursts presented from either the left or right loudspeaker. Although the spatial location of the sounds was entirely task-irrelevant, all groups responded more efficiently with uncrossed hands when the sound was presented from the same side as the responding hand ("Simon effect"). This effect reversed with crossed hands only in the congenitally blind: They responded faster with the hand that was located contralateral to the sound source. In Experiment II, the instruction to the participants was changed: They now had to respond with the hand located next to the sound source. In contrast to Experiment I ("Simon-task"), this task required an explicit matching of the sound's location with the position of the responding hand. In Experiment II, the congenitally blind participants showed a significantly larger crossing deficit than both the sighted and late blind adults. This pattern of results implies that developmental vision induces the default use of an external coordinate frame for multisensory action control; this facilitates not only visual but also auditory-manual control.

Evaluation of a spirituality informed e-mental health tool as an intervention for major depressive disorder in adolescents and young adults - a randomized controlled pilot trial.

PubMed

Rickhi, Badri; Kania-Richmond, Ania; Moritz, Sabine; Cohen, Jordan; Paccagnan, Patricia; Dennis, Charlotte; Liu, Mingfu; Malhotra, Sonya; Steele, Patricia; Toews, John

2015-12-24

Depression in adolescents and young adults is a major mental health condition that requires attention. Research suggests that approaches that include spiritual concepts and are delivered through an online platform are a potentially beneficial approach to treating/managing depression in this population. The purpose of this study was to evaluate the effectiveness of an 8-week online spirituality informed e-mental health intervention (the LEAP Project) on depression severity, and secondary outcomes of spiritual well-being and self-concept, in adolescents and young adults with major depressive disorder of mild to moderate severity. A parallel group, randomized, waitlist controlled, assessor-blinded clinical pilot trial was conducted in Calgary, Alberta, Canada. The sample of 62 participants with major depressive disorder (DSM-IV-TR) was defined by two age subgroups: adolescents (ages 13 to 18 years; n = 31) and young adults (ages 19 to 24 years; n = 31). Participants in each age subgroup were randomized into the study arm (intervention initiated upon enrolment) or the waitlist control arm (intervention initiated after an 8-week wait period). Comparisons were made between the study and waitlist control arms at week 8 (the point where study arm had completed the intervention and the waitlist control arm had not) and within each arm at four time points over 24-week follow-up period. At baseline, there was no statistical difference between study and waitlist participants for both age subgroups for all three outcomes of interest. After the intervention, depression severity was significantly reduced; comparison across arms at week 8 and over time within each arm and both age subgroups. Spiritual well-being changes were not significant, with the exception of an improvement over time for the younger participants in the study arm (p = 0.01 at week 16 and p = 0.0305 at week 24). Self-concept improved significantly for younger participants immediately after the intervention (p = 0.045 comparison across arms at week 8; p = 0.0175 in the waitlist control arm) and over time in the study arm (p = 0.0025 at week 16). In the older participants, change was minimal, with the exception of a significant improvement in one of six factors (vulnerability) in study arm over time (p = 0.025 at week 24). The results of the LEAP Project pilot trial suggest that it is an effective, online intervention for youth ages 13 to 24 with mild to moderate major depressive disorder with various life situations and in a limited way on spiritual well-being and self-concept. ClinicalTrials.gov NCT00985686. Registered 24 September 2009.

Ocular morbidity patterns among children in schools for the blind in Chennai.

PubMed

Prakash, M Vs; Sivakumar, S; Dayal, Ashutosh; Chitra, A; Subramaniam, Sudharshini

2017-08-01

To identify the morbidity patterns causing blindness in children attending schools for the blind in Chennai and comparing our data with similar studies done previously. A cross-sectional prevalence study was carried out in two schools for the blind in Chennai. Blind schools were visited by a team of ophthalmologists and optometrists. Students with best-corrected visual acuity (BCVA) worse than 3/60 in the better eye were included and relevant history was noted. Every student underwent anterior segment evaluation and detailed fundus examination. Morbidity of the better eye was taken as cause of blindness. Health records maintained by the school were referred to wherever available. The anatomical causes of blindness include optic nerve disorders in 75 (24.8%) cases, retinal disorders in 55 (18.2%), corneal disorders in 47 (15.6%), lens-related disorders in 39 (12.9%), congenital anomalies in 11 (3.6%), and congenital glaucoma in 20 (6.6%) cases. The whole globe was involved in six cases (1.99%). Among conditions causing blindness, optic atrophy seen in 73 (24.17%) cases was the most common, followed by retinal dystrophy in 44 (14.56%), corneal scarring in 35 (11.59%), cataract in 22 (7.28%), and congenital glaucoma in 20 (6.6%) cases. It was found that avoidable causes of blindness were seen in 31% of cases and incurable causes in 45%. Optic nerve atrophy and retinal dystrophy are the emerging causes of blindness, underlining the need for genetic counseling and low vision rehabilitation centers, along with a targeted approach for avoidable causes of blindness.

Ocular morbidity patterns among children in schools for the blind in Chennai

PubMed Central

Prakash, MVS; Sivakumar, S; Dayal, Ashutosh; Chitra, A; Subramaniam, Sudharshini

2017-01-01

Purpose: To identify the morbidity patterns causing blindness in children attending schools for the blind in Chennai and comparing our data with similar studies done previously. Methods: A cross-sectional prevalence study was carried out in two schools for the blind in Chennai. Blind schools were visited by a team of ophthalmologists and optometrists. Students with best-corrected visual acuity (BCVA) worse than 3/60 in the better eye were included and relevant history was noted. Every student underwent anterior segment evaluation and detailed fundus examination. Morbidity of the better eye was taken as cause of blindness. Health records maintained by the school were referred to wherever available. Results: The anatomical causes of blindness include optic nerve disorders in 75 (24.8%) cases, retinal disorders in 55 (18.2%), corneal disorders in 47 (15.6%), lens-related disorders in 39 (12.9%), congenital anomalies in 11 (3.6%), and congenital glaucoma in 20 (6.6%) cases. The whole globe was involved in six cases (1.99%). Among conditions causing blindness, optic atrophy seen in 73 (24.17%) cases was the most common, followed by retinal dystrophy in 44 (14.56%), corneal scarring in 35 (11.59%), cataract in 22 (7.28%), and congenital glaucoma in 20 (6.6%) cases. Conclusion: It was found that avoidable causes of blindness were seen in 31% of cases and incurable causes in 45%. Optic nerve atrophy and retinal dystrophy are the emerging causes of blindness, underlining the need for genetic counseling and low vision rehabilitation centers, along with a targeted approach for avoidable causes of blindness. PMID:28820161

A bill to amend title 10, United States Code, to require a plan to ensure the military leadership of the Armed Forces reflects the diversity of the population of the United States, and for other purposes.

THOMAS, 112th Congress

Sen. Gillibrand, Kirsten E. [D-NY

2012-05-15

Senate - 05/15/2012 Read twice and referred to the Committee on Armed Services. (All Actions) Notes: For further action, see H.R.4310, which became Public Law 112-239 on 1/2/2013. Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Understanding and Targeting Epigenetic Alterations in Acquired Bone Marrow Failure

DTIC Science & Technology

2015-05-01

Cre 1 2 P95H 3 Activated allele Neo Lox P Frt Long homology arm Short homology arm Neo cassette Probe primer P95H (GGC => GTG ) Reference: 297...right) (th indicates 95% confidence interval by bootstrapping. The schematic illustrates a p left to right, the features are the upstream exon ( gray box...and intron (black line), t (black line) and exon ( gray box). Horizontal axis, genomic coordinates defined with relative frequency of the indicated

Comparing non-invasive scapular tracking methods across elevation angles, planes of elevation and humeral axial rotations.

PubMed

Grewal, T-J; Cudlip, A C; Dickerson, C R

2017-12-01

Altered scapular motions premeditate shoulder impingement and other musculoskeletal disorders. Divergent experimental conditions in previous research precludes rigorous comparisons of non-invasive scapular tracking techniques. This study evaluated scapular orientation measurement methods across an expanded range of humeral postures. Scapular medial/lateral rotation, anterior/posterior tilt and protraction/retraction was measured using an acromion marker cluster (AMC), a scapular locator, and a reference stylus. Motion was captured using reflective markers on the upper body, as well as on the AMC, locator and stylus. A combination of 5 arm elevation angles, 3 arm elevation planes and 3 arm axial rotations was examined. Measurement method interacted with elevation angle and plane of elevation for all three scapular orientation directions (p < 0.01). Method of measurement interacted with axial rotation in anterior/posterior tilt and protraction/retraction (p < 0.01). The AMC had strong agreement with the reference stylus than the locator for the majority of humeral elevations, planes and axial rotations. The AMC underestimated lateral rotation, with the largest difference of ∼2° at 0° elevation. Both the locator and AMC overestimated posterior tilt at high arm elevation by up to 7.4°. Misestimations from using the locator could be enough to potentially obscure meaningful differences in scapular rotations. Copyright © 2017 Elsevier Ltd. All rights reserved.

Improving the efficiency of optical coherence tomography by using the non-ideal behaviour of a polarising beam splitter.

PubMed

Lippok, Norman; Nielsen, Poul; Vanholsbeeck, Frédérique

2011-04-11

We present a new way of improving the efficiency of optical coherence tomography by using the polarisation crosstalk of a polarising beam splitter to direct most of the available source optical power to the sample. The use of a quarter wave plate in both the reference and the sample arms allows most of the sample power to be directed to the detector while adjusting the reference arm to ensure noise optimised operation. As a result, the sensitivity of such a system can be improved by 6 dB, or alternatively the acquisition time can be improved by a factor of 4 for shot noise limited performance,compared to a traditional OCT configuration using a 50/50 beam splitter. © 2011 Optical Society of America

TRUST-tPA trial: Telemedicine for remote collaboration with urgentists for stroke-tPA treatment.

PubMed

Mazighi, Mikael; Meseguer, Elena; Labreuche, Julien; Miroux, Patrick; Le Gall, Catherine; Roy, Patricia; Tubach, Florence; Amarenco, Pierre

2017-01-01

Background Previous observational studies have shown that telemedicine is feasible and safe to deliver intravenous (IV) recombinant tissue plasminogen activator (rt-PA). However, implementation of telemedicine may be challenging. To illustrate this fact, we report a study showing that telemedicine failed to improve clinical outcome and analyze the reasons for this shortcoming. Methods We established a tele-stroke network of 10 emergency rooms (ERs) of community hospitals connected to a stroke center to perform a randomized, open-label clinical trial with blinded outcome evaluation. Eligible patients were randomly assigned to either a usual care arm (i.e. immediate transfer to the stroke center and administration of IV rt-PA if indication was confirmed upon stroke arrival) or tele-thrombolysis arm (i.e. immediate administration of IV rt-PA in ER and transfer to the stroke center). The primary efficacy outcome was an excellent outcome (modified Rankin scale (mRS) 0-1 at 90 days). Secondary endpoints included favorable outcome (90-day mRS 0-2) and early neurological improvement (NIHSS score 0-1 at 24 hours or a decrease of ≥ 4 points within 24 hours). Safety outcomes included symptomatic intracerebral hemorrhage (ICH) per ECASS II definition, any ICH and all-cause mortality. Results During an accrual time of 48 months, because of a slow enrollment rate, only 49 of 270 patients initially planned for inclusion were randomized into usual care ( n = 23) and tele-thrombolysis ( n = 26). Despite random assignment, patients allocated to tele-thrombolysis were older and had more severe stroke than patients allocated to usual care. The median duration of video-conference was 23 minutes in the usual care arm and 73 minutes in the tele-thrombolysis arm. Eighty-four percent of patients in the tele-thrombolysis arm were treated by IV rt-PA in comparison to 18% in the usual care arm. In univariate analysis but not after adjustment for age and baseline NIHSS, patients allocated in the usual care arm had a higher rate of excellent or favorable outcome. There were no differences in safety outcomes, with only one symptomatic ICH occurring in the tele-thrombolysis arm. Conclusions Stroke patients included in the telemedicine arm of the TRUST-tPA trial increased their rt-PA eligibility five-fold. However, the efficacy and safety remains to be determined (ClinicalTrials.org, NCT00279149).

Results of Clinicians Using a Therapeutic Robotic System in an Inpatient Stroke Rehabilitation Unit

PubMed Central

2011-01-01

Background Physical rehabilitation is an area where robotics could contribute significantly to improved motor return for individuals following a stroke. This paper presents the results of a preliminary randomized controlled trial (RCT) of a robot system used in the rehabilitation of the paretic arm following a stroke. Methods The study's objectives were to explore the efficacy of this new type of robotic therapy as compared to standard physiotherapy treatment in treating the post-stroke arm; to evaluate client satisfaction with the proposed robotic system; and to provide data for sample size calculations for a proposed larger multicenter RCT. Twenty clients admitted to an inpatient stroke rehabilitation unit were randomly allocated to one of two groups, an experimental (robotic arm therapy) group or a control group (conventional therapy). An occupational therapist blinded to patient allocation administered two reliable measures, the Chedoke Arm and Hand Activity Inventory (CAHAI-7) and the Chedoke McMaster Stroke Assessment of the Arm and Hand (CMSA) at admission and discharge. For both groups, at admission, the CMSA motor impairment stage of the affected arm was between 1 and 3. Results Data were compared to determine the effectiveness of robot-assisted versus conventional therapy treatments. At the functional level, both groups performed well, with improvement in scores on the CAHAI-7 showing clinical and statistical significance. The CAHAI-7 (range7-49) is a measure of motor performance using functional items. Individuals in the robotic therapy group, on average, improved by 62% (95% CI: 26% to 107%) while those in the conventional therapy group changed by 30% (95% CI: 4% to 61%). Although performance on this measure is influenced by hand recovery, our results showed that both groups had similar stages of motor impairment in the hand. Furthermore, the degree of shoulder pain, as measured by the CMSA pain inventory scale, did not worsen for either group over the course of treatment. Conclusion Our findings indicated that robotic arm therapy alone, without additional physical therapy interventions tailored to the paretic arm, was as effective as standard physiotherapy treatment for all responses and more effective than conventional treatment for the CMSA Arm (p = 0.04) and Hand (p = 0.04). At the functional level, both groups performed equally well. PMID:21871095

Results of clinicians using a therapeutic robotic system in an inpatient stroke rehabilitation unit.

PubMed

Abdullah, Hussein A; Tarry, Cole; Lambert, Cynthia; Barreca, Susan; Allen, Brian O

2011-08-26

Physical rehabilitation is an area where robotics could contribute significantly to improved motor return for individuals following a stroke. This paper presents the results of a preliminary randomized controlled trial (RCT) of a robot system used in the rehabilitation of the paretic arm following a stroke. The study's objectives were to explore the efficacy of this new type of robotic therapy as compared to standard physiotherapy treatment in treating the post-stroke arm; to evaluate client satisfaction with the proposed robotic system; and to provide data for sample size calculations for a proposed larger multicenter RCT. Twenty clients admitted to an inpatient stroke rehabilitation unit were randomly allocated to one of two groups, an experimental (robotic arm therapy) group or a control group (conventional therapy). An occupational therapist blinded to patient allocation administered two reliable measures, the Chedoke Arm and Hand Activity Inventory (CAHAI-7) and the Chedoke McMaster Stroke Assessment of the Arm and Hand (CMSA) at admission and discharge. For both groups, at admission, the CMSA motor impairment stage of the affected arm was between 1 and 3. Data were compared to determine the effectiveness of robot-assisted versus conventional therapy treatments. At the functional level, both groups performed well, with improvement in scores on the CAHAI-7 showing clinical and statistical significance. The CAHAI-7 (range7-49) is a measure of motor performance using functional items. Individuals in the robotic therapy group, on average, improved by 62% (95% CI: 26% to 107%) while those in the conventional therapy group changed by 30% (95% CI: 4% to 61%). Although performance on this measure is influenced by hand recovery, our results showed that both groups had similar stages of motor impairment in the hand. Furthermore, the degree of shoulder pain, as measured by the CMSA pain inventory scale, did not worsen for either group over the course of treatment. Our findings indicated that robotic arm therapy alone, without additional physical therapy interventions tailored to the paretic arm, was as effective as standard physiotherapy treatment for all responses and more effective than conventional treatment for the CMSA Arm (p = 0.04) and Hand (p = 0.04). At the functional level, both groups performed equally well.

Blind Demodulation of Pass Band OFDMA Signals and Jamming Battle Damage Assessment Utilizing Link Adaptation

DTIC Science & Technology

2014-03-27

Access (OFDMA) signal so that jamming effectiveness can be assessed; referred to in this research as Battle Damage Assessment ( BDA ). The research extends...the 802.16 Wireless Metropolitan Area Network (MAN) OFDMA standard, and presents a novel method for performing BDA via observation of Sub Carrier (SC...interferer is also evaluated where the blind demodulator’s performance is degraded. BDA is achieved via observing SC LA modulation behavior of the

Venous Thoracic Outlet Syndrome as a Cause of Intractable Migraines.

PubMed

Chahwala, Veer; Tashiro, Jun; Li, Xiaoyi; Baqai, Atif; Rey, Jorge; Robinson, Handel R

2017-02-01

Thoracic outlet syndrome (TOS) refers to the compression of the neurovascular bundle within the thoracic outlet. Cases are classified by primary etiology-arterial, neurogenic, or venous. In addition to the typical symptoms of arm swelling and paresthesias, headaches have been reported as a potential symptom of TOS. In this report, we describe a patient with debilitating migraines, which were consistently preceded by unilateral arm swelling. Resolution of symptoms occurred only after thoracic outlet decompression. Patients with migraines and concomitant swelling and/or paresthesias, especially related to provocative arm maneuvers, should be considered a possible atypical presentation of TOS and evaluated in more detail. Copyright © 2016 Elsevier Inc. All rights reserved.

Evaluation of the Environmental Instruments, Incorporated Series 200 Dual Component Wind Set.

DTIC Science & Technology

1980-09-01

elements is sensed to derive the sign (+ or -), which indicates the wind direction across the element pair. The reference arm of the Wheatstone bridge...Csine a for the crosswind axis, r and PF=a Vw Sine a for the headwind axis, r where Pa is the ambient air density, Pr is reference density at standard...pressure transducer is a hybrid linear silicon device which consists of a diaphragm and pressure reference , piezoresistive sensor, signal discriminator

Industry sponsorship bias in research findings: a network meta-analysis of LDL cholesterol reduction in randomised trials of statins

PubMed Central

Dias, Sofia; Ades, A E

2014-01-01

Objective To explore the risk of industry sponsorship bias in a systematically identified set of placebo controlled and active comparator trials of statins. Design Systematic review and network meta-analysis. Eligibility Open label and double blind randomised controlled trials comparing one statin with another at any dose or with control (placebo, diet, or usual care) for adults with, or at risk of developing, cardiovascular disease. Only trials that lasted longer than four weeks with more than 50 participants per trial arm were included. Two investigators assessed study eligibility. Data sources Bibliographic databases and reference lists of relevant articles published between 1 January 1985 and 10 March 2013. Data extraction One investigator extracted data and another confirmed accuracy. Main outcome measure Mean absolute change from baseline concentration of low density lipoprotein (LDL) cholesterol. Data synthesis Study level outcomes from randomised trials were combined using random effects network meta-analyses. Results We included 183 randomised controlled trials of statins, 103 of which were two-armed or multi-armed active comparator trials. When all of the existing randomised evidence was synthesised in network meta-analyses, there were clear differences in the LDL cholesterol lowering effects of individual statins at different doses. In general, higher doses resulted in higher reductions in baseline LDL cholesterol levels. Of a total of 146 industry sponsored trials, 64 were placebo controlled (43.8%). The corresponding number for the non-industry sponsored trials was 16 (43.2%). Of the 35 unique comparisons available in 37 non-industry sponsored trials, 31 were also available in industry sponsored trials. There were no systematic differences in magnitude between the LDL cholesterol lowering effects of individual statins observed in industry sponsored versus non-industry sponsored trials. In industry sponsored trials, the mean change from baseline LDL cholesterol level was on average 1.77 mg/dL (95% credible interval −11.12 to 7.66) lower than the change observed in non-industry sponsored trials. There was no detectable inconsistency in the evidence network. Conclusions Our analysis shows that the findings obtained from industry sponsored statin trials seem similar in magnitude as those in non-industry sources. There are actual differences in the effectiveness of individual statins at various doses that explain previously observed discrepancies between industry and non-industry sponsored trials. PMID:25281681

Six Months of Diazoxide Treatment at Bedtime in Newly Diagnosed Subjects With Type 1 Diabetes Does Not Influence Parameters of β-Cell Function and Autoimmunity but Improves Glycemic Control

PubMed Central

Radtke, Maria Anita; Nermoen, Ingrid; Kollind, Magnus; Skeie, Svein; Sørheim, Jan Inge; Svartberg, Johan; Hals, Ingrid; Moen, Torolf; Dørflinger, Gry Høst; Grill, Valdemar

2010-01-01

OBJECTIVE Continuous β-cell rest with diazoxide preserves residual endogenous insulin production in type 1 diabetes. However, side effects have hampered therapeutic usefulness. In a double-blind study, we tested whether lower, intermittent dosing of diazoxide had beneficial effects on insulin production, metabolic control, and autoimmunity markers in the absence of side effects. RESEARCH DESIGN AND METHODS Forty-one newly diagnosed type 1 diabetic patients were randomized to 6 months of treatment with placebo or 100 mg diazoxide at bedtime. A1C, C-peptide (fasting and glucagon stimulated), and FoxP3+ regulatory T-cells (Tregs) were measured. Patients were followed for 6 months after intervention. RESULTS Of six dropouts, three were due to perceived side effects; one subject in the diazoxide group experienced rash, another dizziness, and one in the placebo group sleep disturbance. Adverse effects in others were absent. Diazoxide treatment reduced A1C from 8.6% at baseline to 6.0% at 6 months and 6.5% at 12 months. Corresponding A1C value in the placebo arm were 8.3, 7.3, and 7.5% (P < 0.05 for stronger reduction in the diazoxide group). Fasting and stimulated C-peptide decreased during 12 months similarly in both arms (mean −0.30 and −0.18 nmol/l in the diazoxide arm and −0.08 and −0.09 nmol/l in the placebo arm). The proportion of Tregs was similar in both arms and remained stable during intervention but was significantly lower compared with nondiabetic subjects. CONCLUSIONS Six months of low-dose diazoxide was without side effects and did not measurably affect insulin production but was associated with improved metabolic control. PMID:20028939

Patient-reported outcomes in a phase iii study of everolimus versus placebo in patients with metastatic carcinoma of the kidney that has progressed on vascular endothelial growth factor receptor tyrosine kinase inhibitor therapy.

PubMed

Beaumont, Jennifer L; Butt, Zeeshan; Baladi, Jeanfrancois; Motzer, Robert J; Haas, Tomas; Hollaender, Norbert; Kay, Andrea; Cella, David

2011-01-01

A phase III, randomized, double-blind, placebo-controlled trial was conducted in patients with metastatic renal cell carcinoma. The focus of this paper is to evaluate the patient-reported outcomes. Patients were randomly assigned (2:1) to receive oral everolimus 10 mg once daily or placebo. The Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease-Related Symptoms (FKSI-DRS) and European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 were administered before randomization and on day 1 of each cycle. The FKSI-DRS and the EORTC QLQ-C30 Physical Functioning and Global Quality of Life scores were the primary endpoints examined. Longitudinal models were used to compare treatment arms. Sensitivity analyses were conducted to explore the impact of missing data assumptions. Longitudinal trends for FKSI-DRS scores did not differ by treatment arm. Taking nonignorable missing data into account, there were significant differences between treatment arms in the trend over time for physical functioning and global quality of life, with the everolimus arm exhibiting greater decreases. All three of these measures of health-related quality of life were significantly related to progression-free survival. There was no evidence of a difference between everolimus and placebo in longitudinal patterns of disease-related symptoms, and little difference between the arms in physical functioning or global quality of life trends. This supports the conclusion that delay in tumor progression demonstrated by everolimus is associated with minimal impact on symptoms, physical functioning, or quality of life, as reported by patients.

Patient-Reported Outcomes in a Phase III Study of Everolimus Versus Placebo in Patients with Metastatic Carcinoma of the Kidney That Has Progressed on Vascular Endothelial Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy

PubMed Central

Butt, Zeeshan; Baladi, Jeanfrancois; Motzer, Robert J.; Haas, Tomas; Hollaender, Norbert; Kay, Andrea; Cella, David

2011-01-01

Purpose. A phase III, randomized, double-blind, placebo-controlled trial was conducted in patients with metastatic renal cell carcinoma. The focus of this paper is to evaluate the patient-reported outcomes. Methods. Patients were randomly assigned (2:1) to receive oral everolimus 10 mg once daily or placebo. The Functional Assessment of Cancer Therapy Kidney Symptom Index—Disease-Related Symptoms (FKSI-DRS) and European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 were administered before randomization and on day 1 of each cycle. The FKSI-DRS and the EORTC QLQ-C30 Physical Functioning and Global Quality of Life scores were the primary endpoints examined. Longitudinal models were used to compare treatment arms. Sensitivity analyses were conducted to explore the impact of missing data assumptions. Results. Longitudinal trends for FKSI-DRS scores did not differ by treatment arm. Taking nonignorable missing data into account, there were significant differences between treatment arms in the trend over time for physical functioning and global quality of life, with the everolimus arm exhibiting greater decreases. All three of these measures of health-related quality of life were significantly related to progression-free survival. Conclusions. There was no evidence of a difference between everolimus and placebo in longitudinal patterns of disease-related symptoms, and little difference between the arms in physical functioning or global quality of life trends. This supports the conclusion that delay in tumor progression demonstrated by everolimus is associated with minimal impact on symptoms, physical functioning, or quality of life, as reported by patients. PMID:21459902

Iron-Magnesium Hydroxycarbonate (Fermagate): A Novel Non-Calcium-Containing Phosphate Binder for the Treatment of Hyperphosphatemia in Chronic Hemodialysis Patients

PubMed Central

McIntyre, Christopher W.; Pai, Pearl; Warwick, Graham; Wilkie, Martin; Toft, Alex J.; Hutchison, Alastair J.

2009-01-01

Background and objectives: This phase II study tested the safety and efficacy of fermagate, a calcium-free iron and magnesium hydroxycarbonate binder, for treating hyperphosphatemia in hemodialysis patients. Design, setting, participants, & measurements: A randomized, double-blind, three-arm, parallel-group study compared two doses of fermagate (1 g three times daily or 2 g three times daily with placebo). Sixty-three patients who had been on a stable hemodialysis regimen for ≥3 mo were randomized to the treatment phase. Study medication was administered three times daily just before meals for 21 d. The primary endpoint was reduction in serum phosphate over this period. Results: In the intention-to-treat analysis, mean baseline serum phosphate was 2.16 mmol/L. The fermagate 1- and 2-g three-times-daily treatment arms were associated with statistical reductions in mean serum phosphate to 1.71 and 1.47 mmol/L, respectively. Adverse event (AE) incidence in the 1-g fermagate arm was statistically comparable to the placebo group. The 2-g arm was associated with a statistically higher number of patients reporting AEs than the 1-g arm, particularly gastrointestinal AEs, as well as a higher number of discontinuations, complicating interpretation of this dose's efficacy. Both doses were associated with elevations of prehemodialysis serum magnesium levels. Conclusions: The efficacy and tolerability of fermagate were dose dependent. Fermagate showed promising efficacy in the treatment of hyperphosphatemia in chronic hemodialysis patients as compared with placebo in this initial phase II study. The optimal balance between efficacy and tolerability needs to be determined from future dose-titration studies, or fixed-dose comparisons of more doses. PMID:19158369

W.W. Morgan and the Discovery of the Spiral Arm Structure of our Galaxy

NASA Astrophysics Data System (ADS)

Sheehan, William

2008-03-01

William Wilson Morgan was one of the great astronomers of the twentieth century. He considered himself a morphologist, and was preoccupied throughout his career with matters of classification. Though, his early life was difficult, and his pursuit of astronomy as a career was opposed by his father, he took a position at Yerkes Observatory in 1926 and remained there for the rest of his working life. Thematically, his work was also a unified whole. Beginning with spectroscopic studies under Otto Struve at Yerkes Observatory, by the late 1930s he concentrated particularly on the young O and B stars. His work an stellar classification led to the Morgan-Keenan-Kellman [MKK] system of classification of stars, and later - as he grappled with the question of the intrinsic color and brightness of stars at great distances - to the Johnson-Morgan UBV system for measuring stellar colors. Eventually these concerns with classification and method led to his greatest single achievement - the recognition of the nearby spiral arms of our Galaxy by tracing the OB associations and HII regions that outline them. After years of intensive work on the problem of galactic structure, the discovery came in a blinding flash of Archimedean insight as he walked under the night sky between his office and his house in the autumn of 1951. His optical discovery of the spiral arms preceded the radio-mapping of the spiral arms by more than a year. Morgan suffered a nervous breakdown soon after he announced his discovery, however, and so was prevented from publishing a complete account of his work. As a result of that, and the announcement soon afterward of the first radio maps of the spiral arms, the uniqueness of his achievement was not fully appreciated at the time.

HIV salvage therapy does not require nucleoside reverse transcriptase inhibitors: a randomized trial

PubMed Central

Tashima, Karen T; Smeaton, Laura M; Fichtenbaum, Carl J; Andrade, Adriana; Eron, Joseph J; Gandhi, Rajesh T; Johnson, Victoria A; Klingman, Karin L; Ritz, Justin; Hodder, Sally; Santana, Jorge L; Wilkin, Timothy; Haubrich, Richard H

2015-01-01

Background Nucleoside reverse transcriptase inhibitors (NRTIs) are often included in antiretroviral (ARV) regimens in treatment-experienced patients in the absence of data from randomized trials. Objective To compare treatment success between participants who omit versus Add NRTIs to an optimized ARV regimen of three or more agents. Design Multisite, randomized, controlled trial. Setting Outpatient HIV clinics. Participants HIV-infected patients with three-class ARV experience and/or viral resistance. Intervention Open-label optimized regimens (not including NRTIs) were selected based upon treatment history and susceptibility testing. Participants were randomized to Omit or Add NRTIs. Measurements The primary efficacy outcome was regimen failure through week 48, using a non-inferiority margin of 15%. The primary safety outcome was time to initial episode of severe sign/symptom or laboratory abnormality prior to discontinuation of NRTI assignment. Results 360 participants were randomized and 93% completed a week 48 visit. The cumulative probability of regimen failure was 29.8% in the Omit NRTI arm versus 25.9% in the Add NRTI arm (difference= 3.2%: 95% CI, −6.1 to 12.5). There were no significant differences in the primary safety endpoints or the proportion of participants with HIV RNA <50 copies/mL between arms. No deaths occurred in the Omit NRTIs arm, compared with 7 deaths in the Add NRTIs arm. Limitations Non-blinded study design and may not be applicable to resource poor settings. Conclusion HIV-infected treatment-experienced patients starting a new optimized regimen can safely omit NRTIs without compromising virologic efficacy. Omitting NRTIs will reduce pill burden, cost, and toxicity in this patient population. PMID:26595748

Comparison of the oscillometric blood pressure monitor (BPM-100(Beta) ) with the auscultatory mercury sphygmomanometer.

PubMed

Mattu, G S; Perry, T L; Wright, J M

2001-06-01

To compare directly the accuracy of the BPM-100(Beta) monitor (an automated oscillometric blood pressure device) with standard auscultatory mercury sphygmomanometry. The BPM-100(Beta) was connected in parallel via a T-tube to a mercury sphygmomanometer. The BPM-100(Beta) and two trained observers (blinded from each other and from the BPM-100(Beta)) measured the sitting blood pressure simultaneously. Means, standard deviations and ranges were calculated for all the demographic data: age, arm size, heart rate and blood pressure. The agreement between the BPM-100(Beta) and the mean of two observers (the reference) was determined and expressed as the mean +/- SD, as well as the percentage of differences falling within 5, 10 and 15 mmHg. Of the 92 subjects recruited, 85 (92.4%) met the inclusion criteria, and 391 sets of sitting blood pressure and heart rate measurements were available for analysis. The mean difference between the BPM-100(Beta) monitor and the reference was -0.62 +/- 6.96 mmHg for systolic blood pressure, -1.48 +/- 4.80 mmHg for diastolic blood pressure and 0.14 +/- 1.86 beats/min for heart rate. The only limitation of the device was its tendency to underestimate higher systolic blood pressures. This problem has been addressed by a minor change in the algorithm (see the companion publication, Blood Press Monit, 6, 161-165, 2001). The BPM-100(Beta) is an accurate blood pressure monitor for the office setting, meeting all requirements of the Association for the Advancement of Medical Instrumentation and achieving an 'A' grade according to the British Hypertension Society protocol.

Tablet computers versus optical aids to support education and learning in children and young people with low vision: protocol for a pilot randomised controlled trial, CREATE (Children Reading with Electronic Assistance To Educate).

PubMed

Crossland, Michael D; Thomas, Rachel; Unwin, Hilary; Bharani, Seelam; Gothwal, Vijaya K; Quartilho, Ana; Bunce, Catey; Dahlmann-Noor, Annegret

2017-06-21

Low vision and blindness adversely affect education and independence of children and young people. New 'assistive' technologies such as tablet computers can display text in enlarged font, read text out to the user, allow speech input and conversion into typed text, offer document and spreadsheet processing and give access to wide sources of information such as the internet. Research on these devices in low vision has been limited to case series. We will carry out a pilot randomised controlled trial (RCT) to assess the feasibility of a full RCT of assistive technologies for children/young people with low vision. We will recruit 40 students age 10-18 years in India and the UK, whom we will randomise 1:1 into two parallel groups. The active intervention will be Apple iPads; the control arm will be the local standard low-vision aid care. Primary outcomes will be acceptance/usage, accessibility of the device and trial feasibility measures (time to recruit children, lost to follow-up). Exploratory outcomes will be validated measures of vision-related quality of life for children/young people as well as validated measures of reading and educational outcomes. In addition, we will carry out semistructured interviews with the participants and their teachers. NRES reference 15/NS/0068; dissemination is planned via healthcare and education sector conferences and publications, as well as via patient support organisations. NCT02798848; IRAS ID 179658, UCL reference 15/0570. © 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.

Tablet computers versus optical aids to support education and learning in children and young people with low vision: protocol for a pilot randomised controlled trial, CREATE (Children Reading with Electronic Assistance To Educate)

PubMed Central

Crossland, Michael D; Thomas, Rachel; Unwin, Hilary; Bharani, Seelam; Gothwal, Vijaya K; Quartilho, Ana; Bunce, Catey

2017-01-01

Introduction Low vision and blindness adversely affect education and independence of children and young people. New ‘assistive’ technologies such as tablet computers can display text in enlarged font, read text out to the user, allow speech input and conversion into typed text, offer document and spreadsheet processing and give access to wide sources of information such as the internet. Research on these devices in low vision has been limited to case series. Methods and analysis We will carry out a pilot randomised controlled trial (RCT) to assess the feasibility of a full RCT of assistive technologies for children/young people with low vision. We will recruit 40 students age 10–18 years in India and the UK, whom we will randomise 1:1 into two parallel groups. The active intervention will be Apple iPads; the control arm will be the local standard low-vision aid care. Primary outcomes will be acceptance/usage, accessibility of the device and trial feasibility measures (time to recruit children, lost to follow-up). Exploratory outcomes will be validated measures of vision-related quality of life for children/young people as well as validated measures of reading and educational outcomes. In addition, we will carry out semistructured interviews with the participants and their teachers. Ethics and dissemination NRES reference 15/NS/0068; dissemination is planned via healthcare and education sector conferences and publications, as well as via patient support organisations. Trial registration number NCT02798848; IRAS ID 179658, UCL reference 15/0570. PMID:28637740

The early use of botulinum toxin in post-stroke spasticity: study protocol for a randomised controlled trial.

PubMed

Lindsay, Cameron; Simpson, Julie; Ispoglou, Sissi; Sturman, Steve G; Pandyan, Anand D

2014-01-08

Patients surviving stroke but who have significant impairment of function in the affected arm are at more risk of developing pain, stiffness and contractures. The abnormal muscle activity, associated with post-stroke spasticity, is thought to be causally associated with the development of these complications. Treatment of spasticity is currently delayed until a patient develops signs of these complications. This protocol is for a phase II study that aims to identify whether using OnabotulinumtoxinA (BoNT-A) in combination with physiotherapy early post stroke when initial abnormal muscle activity is neurophysiologically identified can prevent loss of range at joints and improve functional outcomes.The trial uses a screening phase to identify which people are appropriate to be included in a double blind randomised placebo-controlled trial. All patients admitted to Sandwell and West Birmingham NHS Trust Hospitals with a diagnosis of stroke will be screened to identify functional activity in the arm. Those who have no function will be appropriate for further screening. Patients who are screened and have abnormal muscle activity identified on EMG will be given electrical stimulation to forearm extensors for 3 months and randomised to have either injections of BoNT-A or normal saline. The primary outcome measure is the action research arm test - a measure of arm function. Further measures include spasticity, stiffness, muscle strength and fatigue as well as measures of quality of life, participation and caregiver strain. ISRCTN57435427, EudraCT2010-021257-39, NCT01882556.

Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial

PubMed Central

Street, Alexander J; Magee, Wendy L; Bateman, Andrew; Parker, Michael; Odell-Miller, Helen; Fachner, Jorg

2017-01-01

Objective: To assess the feasibility of a randomized controlled trial to evaluate music therapy as a home-based intervention for arm hemiparesis in stroke. Design: A pilot feasibility randomized controlled trial, with cross-over design. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes. Setting: Participants’ homes across Cambridgeshire, UK. Subjects: Eleven people with stroke and arm hemiparesis, 3–60 months post stroke, following discharge from community rehabilitation. Interventions: Each participant engaged in therapeutic instrumental music performance in 12 individual clinical contacts, twice weekly for six weeks. Main measures: Feasibility was estimated by recruitment from three community stroke teams over a 12-month period, attrition rates, completion of treatment and successful data collection. Structured interviews were conducted pre and post intervention to establish participant tolerance and preference. Action Research Arm Test and Nine-hole Peg Test data were collected at weeks 1, 6, 9, 15 and 18, pre and post intervention by a blinded assessor. Results: A total of 11 of 14 invited participants were recruited (intervention n = 6, waitlist n = 5). In total, 10 completed treatment and data collection. Conclusion: It cannot be concluded whether a larger trial would be feasible due to unavailable data regarding a number of eligible patients screened. Adherence to treatment, retention and interview responses might suggest that the intervention was motivating for participants. Trial registration: ClinicalTrials.gov identifier NCT 02310438. PMID:28643570

A randomized, double-blind, placebo-controlled clinical trial on the treatment of vitamin D insufficiency in postmenopausal women

PubMed Central

Hansen, Karen E.; Johnson, R. Erin; Chambers, Kaitlin R.; Johnson, Michael G.; Lemon, Christina C.; Thuy Vo, Tien Nguyen; Marvdashti, Sheeva

2015-01-01

Importance Experts debate optimal 25(OH)D levels for musculoskeletal health. Objective To compare effects of placebo, low-dose and high-dose vitamin D on one-year changes in total fractional calcium absorption, bone mineral density, Timed-Up-and-Go and 5-sit-to-stand tests and muscle mass in postmenopausal women with vitamin D insufficiency. Design Randomized, double-blind, placebo-controlled, clinical trial conducted from May 2010 to August 2014. Setting Single-center trial conducted in Madison, Wisconsin. Participants 230 postmenopausal women ≤75 years old with baseline 25(OH)D levels 14-27 ng/mL and no osteoporosis. Intervention Three arms included daily white and twice monthly yellow placebo (n=76), daily 800 IU vitamin D3 and twice monthly yellow placebo (n=76), and daily white placebo and twice monthly 50,000 IU vitamin D3 (n=79). The high-dose vitamin D regimen achieved and maintained 25(OH)D levels ≥30 ng/mL. Main Outcome Measures One year change in total fractional calcium absorption using two stable isotopes, bone mineral density and muscle mass using dual energy x-ray absorptiometry, Timed-Up-and-Go and 5-Sit-to-Stand tests, functional status (Health Assessment Questionnaire) and physical activity (Physical Activity Scale for the Elderly), with Benjamini-Hochberg correction of p-values to control the false discovery rate. Results After controlling for baseline absorption, calcium absorption increased 1% (10 mg/day) in the high-dose arm, but decreased by 2% in low-dose (p=0.005 vs. high-dose) and by 1.3% placebo (p=0.03 vs. high-dose) arms. We found no between-arm changes in spine, mean total hip, mean femoral neck or total body bone mineral density, trabecular bone score, muscle mass, 5-sit-to-stand or Timed-Up-and-Go test scores. Likewise, we found no between-arm differences for numbers of falls, number of fallers, physical activity or functional status. Conclusion and Relevance High-dose vitamin D therapy increased calcium absorption, but the effect was small and did not translate into beneficial effects on bone mineral density, muscle function, muscle mass or falls. We found no data to support experts’ recommendations to maintain serum 25(OH)D levels ≥30 ng/mL in postmenopausal women. Instead, we found that low and high-dose vitamin D were equivalent to placebo, in their effects on bone and muscle outcomes in this cohort of postmenopausal women with 25(OH)D levels <30 ng/mL. ClinicalTrials.gov.Identifier:NCT00933244 PMID:26237520

Intervention randomized controlled trials involving wrist and shoulder arthroscopy: a systematic review

PubMed Central

2014-01-01

Background Although arthroscopy of upper extremity joints was initially a diagnostic tool, it is increasingly used for therapeutic interventions. Randomized controlled trials (RCTs) are considered the gold standard for assessing treatment efficacy. We aimed to review the literature for intervention RCTs involving wrist and shoulder arthroscopy. Methods We performed a systematic review for RCTs in which at least one arm was an intervention performed through wrist arthroscopy or shoulder arthroscopy. PubMed and Cochrane Library databases were searched up to December 2012. Two researchers reviewed each article and recorded the condition treated, randomization method, number of randomized participants, time of randomization, outcomes measures, blinding, and description of dropouts and withdrawals. We used the modified Jadad scale that considers the randomization method, blinding, and dropouts/withdrawals; score 0 (lowest quality) to 5 (highest quality). The scores for the wrist and shoulder RCTs were compared with the Mann–Whitney test. Results The first references to both wrist and shoulder arthroscopy appeared in the late 1970s. The search found 4 wrist arthroscopy intervention RCTs (Kienböck’s disease, dorsal wrist ganglia, volar wrist ganglia, and distal radius fracture; first 3 compared arthroscopic with open surgery). The median number of participants was 45. The search found 50 shoulder arthroscopy intervention RCTs (rotator cuff tears 22, instability 14, impingement 9, and other conditions 5). Of these, 31 compared different arthroscopic treatments, 12 compared arthroscopic with open treatment, and 7 compared arthroscopic with nonoperative treatment. The median number of participants was 60. The median modified Jadad score for the wrist RCTs was 0.5 (range 0–1) and for the shoulder RCTs 3.0 (range 0–5) (p = 0.012). Conclusion Despite the increasing use of wrist arthroscopy in the treatment of various wrist disorders the efficacy of arthroscopically performed wrist interventions has been studied in only 4 randomized studies compared to 50 randomized studies of significantly higher quality assessing interventions performed through shoulder arthroscopy. PMID:25059881

Design considerations for an astronaut monorail system for large space structures and the structural characterization of its positioning arm

NASA Astrophysics Data System (ADS)

Watson, Judith J.

1992-08-01

An astronaut monorail system (AMS) is presented as a vehicle to transport and position EVA astronauts along large space truss structures. The AMS is proposed specifically as an alternative to the crew and equipment transfer aid for Space Station Freedom. Design considerations for the AMS were discussed and a reference configuration was selected for the study. Equations were developed to characterize the stiffness and frequency behavior of the AMS positioning arm. Experimental data showed that these equations gave a fairly accurate representation of the stiffness and frequency behavior of the arm. A study was presented to show trends for the arm behavior based on varying parameters of the stiffness and frequency equations. An ergonomics study was conducted to provide boundary conditions for tolerable frequency and deflection to be used in developing a design concept for the positioning arm. The feasibility of the AMS positioning arm was examined using equations and working curves developed in this study. It was found that a positioning arm of a length to reach all interior points of the space station truss structure could not be designed to satisfy frequency and deflection constraints. By relaxing the design requirements and the ergonomic boundaries, an arm could be designed which would provide a stable work platform for the EVA astronaut and give him access to over 75 percent of the truss interior.

The inter-arm systolic blood pressure difference and risk of cardiovascular mortality: A meta-analysis of cohort studies.

PubMed

Zhou, Ming; Gao, Zhen; Chen, Fei; Xu, Haijun; Dong, Xiao; Ma, Li

2016-01-01

The inter-arm systolic blood pressure difference (SBPD) is recommended to be in relation to potential cardiovascular disease (CVD). Previous studies yielded controversial results about the association between an inter-arm SBPD ≥ 10 mmHg or ≥15 mmHg and the risk of cardiovascular mortality. Therefore, we conducted this meta-analysis to investigate this association. We searched PubMed and Embase databases through December 31, 2014, and examined the references of retrieved articles to identify relevant cohort studies. We utilized Newcastle-Ottawa scale to assess the quality of included studies and calculated the summary risk estimates in a fixed/random-effect model. All data analyses were conducted using STATA version 11.0. A total of seven studies were identified. Compared with participants with an inter-arm SBPD < 10 mmHg, the pooled hazard ratio (HR) of CVD mortality of those with an inter-arm SBPD ≥ 10 mmHg was 1.58 (95% CI: 1.3-1.93), and the pooled HR of cardiovascular mortality of participants with an inter-arm SBPD ≥ 15 mmHg versus those with an inter-arm SBPD < 15 mmHg was 1.88 (95% CI: 1.33-2.66). The findings from the present meta-analysis indicated that the detection of an inter-arm SBPD may define a subpopulation at high risk of CVD events.

Properties of intermodal transfer after dual visuo- and auditory-motor adaptation.

PubMed

Schmitz, Gerd; Bock, Otmar L

2017-10-01

Previous work documented that sensorimotor adaptation transfers between sensory modalities: When subjects adapt with one arm to a visuomotor distortion while responding to visual targets, they also appear to be adapted when they are subsequently tested with auditory targets. Vice versa, when they adapt to an auditory-motor distortion while pointing to auditory targets, they appear to be adapted when they are subsequently tested with visual targets. Therefore, it was concluded that visuomotor as well as auditory-motor adaptation use the same adaptation mechanism. Furthermore, it has been proposed that sensory information from the trained modality is weighted larger than sensory information from an untrained one, because transfer between sensory modalities is incomplete. The present study tested these hypotheses for dual arm adaptation. One arm adapted to an auditory-motor distortion and the other either to an opposite directed auditory-motor or visuomotor distortion. We found that both arms adapted significantly. However, compared to reference data on single arm adaptation, adaptation in the dominant arm was reduced indicating interference from the non-dominant to the dominant arm. We further found that arm-specific aftereffects of adaptation, which reflect recalibration of sensorimotor transformation rules, were stronger or equally strong when targets were presented in the previously adapted compared to the non-adapted sensory modality, even when one arm adapted visually and the other auditorily. The findings are discussed with respect to a recently published schematic model on sensorimotor adaptation. Copyright © 2017 Elsevier B.V. All rights reserved.

Sample size determinations for group-based randomized clinical trials with different levels of data hierarchy between experimental and control arms.

PubMed

Heo, Moonseong; Litwin, Alain H; Blackstock, Oni; Kim, Namhee; Arnsten, Julia H

2017-02-01

We derived sample size formulae for detecting main effects in group-based randomized clinical trials with different levels of data hierarchy between experimental and control arms. Such designs are necessary when experimental interventions need to be administered to groups of subjects whereas control conditions need to be administered to individual subjects. This type of trial, often referred to as a partially nested or partially clustered design, has been implemented for management of chronic diseases such as diabetes and is beginning to emerge more commonly in wider clinical settings. Depending on the research setting, the level of hierarchy of data structure for the experimental arm can be three or two, whereas that for the control arm is two or one. Such different levels of data hierarchy assume correlation structures of outcomes that are different between arms, regardless of whether research settings require two or three level data structure for the experimental arm. Therefore, the different correlations should be taken into account for statistical modeling and for sample size determinations. To this end, we considered mixed-effects linear models with different correlation structures between experimental and control arms to theoretically derive and empirically validate the sample size formulae with simulation studies.

Bayesian approach for assessing non-inferiority in a three-arm trial with pre-specified margin.

PubMed

Ghosh, Samiran; Ghosh, Santu; Tiwari, Ram C

2016-02-28

Non-inferiority trials are becoming increasingly popular for comparative effectiveness research. However, inclusion of the placebo arm, whenever possible, gives rise to a three-arm trial which has lesser burdensome assumptions than a standard two-arm non-inferiority trial. Most of the past developments in a three-arm trial consider defining a pre-specified fraction of unknown effect size of reference drug, that is, without directly specifying a fixed non-inferiority margin. However, in some recent developments, a more direct approach is being considered with pre-specified fixed margin albeit in the frequentist setup. Bayesian paradigm provides a natural path to integrate historical and current trials' information via sequential learning. In this paper, we propose a Bayesian approach for simultaneous testing of non-inferiority and assay sensitivity in a three-arm trial with normal responses. For the experimental arm, in absence of historical information, non-informative priors are assumed under two situations, namely when (i) variance is known and (ii) variance is unknown. A Bayesian decision criteria is derived and compared with the frequentist method using simulation studies. Finally, several published clinical trial examples are reanalyzed to demonstrate the benefit of the proposed procedure. Copyright © 2015 John Wiley & Sons, Ltd.

Enzalutamide in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer: Extended Analysis of the Phase 3 PREVAIL Study.

PubMed

Beer, Tomasz M; Armstrong, Andrew J; Rathkopf, Dana; Loriot, Yohann; Sternberg, Cora N; Higano, Celestia S; Iversen, Peter; Evans, Christopher P; Kim, Choung-Soo; Kimura, Go; Miller, Kurt; Saad, Fred; Bjartell, Anders S; Borre, Michael; Mulders, Peter; Tammela, Teuvo L; Parli, Teresa; Sari, Suha; van Os, Steve; Theeuwes, Ad; Tombal, Bertrand

2017-02-01

Enzalutamide significantly improved radiographic progression-free survival (rPFS) and overall survival (OS) among men with chemotherapy-naïve metastatic castration-resistant prostate cancer at the prespecified interim analysis of PREVAIL, a phase 3, double-blind, randomized study. We evaluated the longer-term efficacy and safety of enzalutamide up to the prespecified number of deaths in the final analysis, which included an additional 20 mo of follow-up for investigator-assessed rPFS, 9 mo of follow-up for OS, and 4 mo of follow-up for safety. Enzalutamide reduced the risk of radiographic progression or death by 68% (hazard ratio [HR] 0.32, 95% confidence interval [CI] 0.28-0.37; p<0.0001) and the risk of death by 23% (HR 0.77, 95% CI 0.67-0.88; p=0.0002). Median investigator-assessed rPFS was 20.0 mo (95% CI 18.9-22.1) in the enzalutamide arm and 5.4 mo (95% CI 4.1-5.6) in the placebo arm. Median OS was 35.3 mo (95% CI 32.2-not yet reached) in the enzalutamide arm and 31.3 mo (95% CI 28.8-34.2) in the placebo arm. At the time of the OS analysis, 167 patients in the placebo arm had crossed over to receive enzalutamide. The most common adverse events in the enzalutamide arm were fatigue, back pain, constipation, and arthralgia. This final analysis of PREVAIL provides more complete assessment of the clinical benefit of enzalutamide. PREVAIL is registered on ClinicalTrials.gov as NCT01212991. According to data from longer follow-up, enzalutamide continued to provide benefit over placebo in patients with metastatic castration-resistant prostate cancer. Copyright © 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Comparison of an additional early visit to routine postpartum care on initiation of long-acting reversible contraception: a randomized trial.

PubMed

Bernard, Caitlin; Wan, Leping; Peipert, Jeffrey F; Madden, Tessa

2018-05-17

To investigate whether an early 3-week postpartum visit in addition to the standard 6-week visit increases LARC initiation by 8weeks postpartum compared to the routine 6-week visit alone. We enrolled pregnant and immediate postpartum women into a prospective randomized, non-blinded trial comparing a single 6-week postpartum visit (routine care) to two visits at 3 and 6weeks postpartum (intervention), with initiation of contraception at the 3-week visit, if desired. All participants received structured contraceptive counseling. Participants completed surveys in-person at baseline and at the time of each postpartum visit. A sample size of 200 total participants was needed to detect a 2-fold difference in LARC initiation (20% vs. 40%). Between May 2016 and March 2017, 200 participants enrolled; outcome data are available for 188. The majority of LARC initiation occurred immediately postpartum (25% of the intervention arm and 27% of the routine care arm). By 8weeks postpartum,34% of participants in the intervention arm initiated LARC, compared to 41% in the routine care arm (p=.35). Overall contraceptive initiation by 8weeks was 83% and84% in the intervention and routine care arms, respectively (p=.79). There was no difference between the arms in the proportion of women who attended at least one postpartum visit (70% vs. 74%, p=.56). The addition of a 3-week postpartum visit to routine care does not increase LARC initiation by 8weeks postpartum. The majority of LARC users desired immediate rather than interval postpartum initiation. Clinicaltrials.govNCT02769676 Implications. The addition of a 3-week postpartum visit to routine care does not increase LARC or overall contraceptive initiation by 8weeks post-partum when the option of immediate postpartum placement is available. The majority of LARC users desired immediate rather than interval postpartum initiation. Copyright © 2018. Published by Elsevier Inc.

Transcranial direct current stimulation (tDCS) of the primary motor cortex and robot-assisted arm training in chronic incomplete cervical spinal cord injury: A proof of concept sham-randomized clinical study.

PubMed

Yozbatiran, Nuray; Keser, Zafer; Davis, Matthew; Stampas, Argyrios; O'Malley, Marcia K; Cooper-Hay, Catherine; Frontera, Joel; Fregni, Felipe; Francisco, Gerard E

2016-07-15

After cervical spinal cord injury, current options for treatment of upper extremity motor functions have been limited to traditional approaches. However, there is a substantial need to explore more rigorous alternative treatments to facilitate motor recovery. To demonstrate whether anodal-primary motor cortex (M1) excitability enhancement (with cathodal-supra orbital area) (atDCS) combined with robot-assisted arm training (R-AAT) will provide greater improvement in contralateral arm and hand motor functions compared to sham stimulation (stDCS) and R-AAT in patients with chronic, incomplete cervical spinal cord injury (iCSCI). In this parallel-group, double-blinded, randomized and sham-controlled trial, nine participants with chronic iCSCI (AIS C and D level) were randomized to receive 10 sessions of atDCS or stDSC combined with R-AAT. Feasibility and tolerability was assessed with attrition rate and occurrence of adverse events, Changes in arm and hand function were assessed with Jebson Taylor Hand Function Test (JTHFT). Amount of Use Scale of Motor Activity Log (AOU-MAL), American Spinal Injury Association Upper Extremity Motor Score and Modified Ashworth Scale (MAS) at baseline, after treatment, and at two-month follow-up. None of the participants missed a treatment session or dropped-out due to adverse events related to the treatment protocol. Participants tended to perform better in JTHFT and AOU-MAL after treatment. Active group at post-treatment and two-month follow-up demonstrated better arm and hand performance compared to sham group. These preliminary findings support that modulating excitatory input of the corticospinal tracts on spinal circuits may be a promising strategy in improving arm and hand functions in persons with incomplete tetraplegia. Further study is needed to explore the underlying mechanisms of recovery.

Armed Prohibited Persons Act of 2013

THOMAS, 113th Congress

Rep. Thompson, Mike [D-CA-5

2013-02-27

House - 04/08/2013 Referred to the Subcommittee on Crime, Terrorism, Homeland Security, And Investigations. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

The pattern of childhood blindness in Karnataka, South India.

PubMed

Gogate, Parikshit; Kishore, H; Dole, Kuldeep; Shetty, Jyoti; Gilbert, Clare; Ranade, Satish; Kumar, Mohan; Srihari; Deshpande, Madan

2009-01-01

To determine the causes of severe visual impairment and blindness in children in schools for the blind in southern Karnataka state of India. Children aged less than 16 years with a visual acuity of < 6/60 in the better eye, attending the residential schools for the blind were examined in 2005-2006, in the Karnataka state in the south of India. History taking, visual acuity estimation, external ocular examination, retinoscopy, and fundoscopy were done on all students. Refraction and low vision work-up done where indicated. The anatomical and etiological causes of severe visual impairment (< 6/60-3/60) and blindness (< 3/60 in the better eye) were classified using the World Health Organization's prevention of blindness programs' record system. A total of 1,179 students were examined, 891 of whom fulfilled the eligibility criteria. The major anatomical sites of visual loss were congenital anomalies (microphthalmos, anophthalmos) (321, 35.7%), corneal conditions (mainly scarring due to vitamin A deficiency, measles, trauma) (133, 14.9%), cataract or aphakia in 102 (11.4%), and retinal disorders (mainly dystrophies) in 177 children (19.9%). Nearly one-fourth of children were blind from conditions which could have been prevented or treated (27.8%), 87 of whom were referred for surgery. Low vision devices improved near acuity in 27 children (3%), and 43 (4.8%) benefited from refraction. Congenital anomalies, cataract, and retinal conditions account for most of the blindness in children.

Physiological Responses to Arm Activity in Individuals With Chronic Obstructive Pulmonary Disease Compared With Healthy Controls: A SYSTEMATIC REVIEW.

PubMed

Lima, Vanessa Pereira; Iamonti, Vinicius C; Velloso, Marcelo; Janaudis-Ferreira, Tania

The mechanisms underlying physiological limitations during arm activity in individuals with chronic obstructive pulmonary disease (COPD) are unknown. The objective of this systematic review was to describe cardiorespiratory responses, symptoms, chest wall kinematics, muscle activity, and lung volumes during arm activity in individuals with COPD relative to the responses of healthy controls. Original research articles that compared cardiorespiratory responses, symptoms, muscle activity, chest wall kinematics, and lung function during arm activity between individuals with COPD and healthy controls were identified after searches of 5 electronic databases and reference lists of pertinent articles. Two reviewers performed the electronic and manual searches with 1 screening title and abstracts. Two investigators screened the full texts to determine eligibility for inclusion. One reviewer performed the data extraction and tabulation using a standardized form with a second reviewer double-checking the data extracted. Of the 54 full-text articles assessed for eligibility, 6 met the inclusion criteria. Reduced cardiorespiratory responses during peak arm exercise in individuals with COPD compared with healthy controls were evident. Compared with healthy controls, individuals with COPD had increased dyspnea and hyperinflation during peak arm exercise. Increased effort of the trapezius muscle during arm activities was also found in persons with COPD compared with healthy controls. There is limited evidence describing physiological responses during arm activity in individuals with COPD. Findings of this systematic review suggest that individuals with COPD have decreased cardiorespiratory responses during peak arm exercise compared with controls but increased dyspnea, hyperinflation, and arm muscle effort.

Timing variability of reach trajectories in left versus right hemisphere stroke.

PubMed

Freitas, Sandra Maria Sbeghen Ferreira; Gera, Geetanjali; Scholz, John Peter

2011-10-24

This study investigated trajectory timing variability in right and left stroke survivors and healthy controls when reaching to a centrally located target under a fixed target condition or when the target could suddenly change position after reach onset. Trajectory timing variability was investigated with a novel method based on dynamic programming that identifies the steps required to time warp one trial's acceleration time series to match that of a reference trial. Greater trajectory timing variability of both hand and joint motions was found for the paretic arm of stroke survivors compared to their non-paretic arm or either arm of controls. Overall, the non-paretic left arm of the LCVA group and the left arm of controls had higher timing variability than the non-paretic right arm of the RCVA group and right arm of controls. The shoulder and elbow joint warping costs were consistent predictors of the hand's warping cost for both left and right arms only in the LCVA group, whereas the relationship between joint and hand warping costs was relatively weak in control subjects and less consistent across arms in the RCVA group. These results suggest that the left hemisphere may be more involved in trajectory timing, although the results may be confounded by skill differences between the arms in these right hand dominant participants. On the other hand, arm differences did not appear to be related to differences in targeting error. The paretic left arm of the RCVA exhibited greater trajectory timing variability than the paretic right arm of the LCVA group. This difference was highly correlated with the level of impairment of the arms. Generally, the effect of target uncertainty resulted in slightly greater trajectory timing variability for all participants. The results are discussed in light of previous studies of hemispheric differences in the control of reaching, in particular, left hemisphere specialization for temporal control of reaching movements. Copyright © 2011 Elsevier B.V. All rights reserved.

TIMING VARIABILITY OF REACH TRAJECTORIES IN LEFT VERSUS RIGHT HEMISPHERE STROKE

PubMed Central

Freitas, Sandra Maria Sbeghen Ferreira; Gera, Geetanjali; Scholz, John Peter

2011-01-01

This study investigated trajectory timing variability in right and left stroke survivors and healthy controls when reaching to a centrally located target under a fixed target condition or when the target could suddenly change position after reach onset. Trajectory timing variability was investigated with a novel method based on dynamic programming that identifies the steps required to time warp one trial’s acceleration time series to match that of a reference trial. Greater trajectory timing variability of both hand and joint motions was found for the paretic arm of stroke survivors compared to their non-paretic arm or either arm of controls. Overall, the non-paretic left arm of the LCVA group and the left arm of controls had higher timing variability than the non-paretic right arm of the RCVA group and right arm of controls. The shoulder and elbow joint warping costs were consistent predictors of the hand’s warping cost for both left and right arms only in the LCVA group, whereas the relationship between joint and hand warping costs was relatively weak in control subjects and less consistent across arms in the RCVA group. These results suggest that the left hemisphere may be more involved in trajectory timing, although the results may be confounded by skill differences between the arms in these right hand dominant participants. On the other hand, arm differences did not appear to be related to differences in targeting error. The paretic left arm of the RCVA exhibited greater trajectory timing variability than the paretic right arm of the LCVA group. This difference was highly correlated with the level of impairment of the arms. Generally, the effect of target uncertainty resulted in slightly greater trajectory timing variability for all participants. The results are discussed in light of previous studies of hemispheric differences in the control of reaching, in particular, left hemisphere specialization for temporal control of reaching movements. PMID:21920508

Unblinding the dark matter blind spots

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

Han, Tao; Kling, Felix; Su, Shufang

The dark matter (DM) blind spots in the Minimal Supersymmetric Standard Model (MSSM) refer to the parameter regions where the couplings of the DM particles to the $Z$-boson or the Higgs boson are almost zero, leading to vanishingly small signals for the DM direct detections. In this paper, we carry out comprehensive analyses for the DM searches under the blind-spot scenarios in MSSM. Guided by the requirement of acceptable DM relic abundance, we explore the complementary coverage for the theory parameters at the LHC, the projection for the future underground DM direct searches, and the indirect searches from the relicmore » DM annihilation into photons and neutrinos. We find that (i) the spin-independent (SI) blind spots may be rescued by the spin-dependent (SD) direct detection in the future underground experiments, and possibly by the indirect DM detections from IceCube and SuperK neutrino experiments; (ii) the detection of gamma rays from Fermi-LAT may not reach the desirable sensitivity for searching for the DM blind-spot regions; (iii) the SUSY searches at the LHC will substantially extend the discovery region for the blind-spot parameters. As a result, the dark matter blind spots thus may be unblinded with the collective efforts in future DM searches.« less

Unblinding the dark matter blind spots

DOE PAGES

Han, Tao; Kling, Felix; Su, Shufang; ...

2017-02-10

The dark matter (DM) blind spots in the Minimal Supersymmetric Standard Model (MSSM) refer to the parameter regions where the couplings of the DM particles to the $Z$-boson or the Higgs boson are almost zero, leading to vanishingly small signals for the DM direct detections. In this paper, we carry out comprehensive analyses for the DM searches under the blind-spot scenarios in MSSM. Guided by the requirement of acceptable DM relic abundance, we explore the complementary coverage for the theory parameters at the LHC, the projection for the future underground DM direct searches, and the indirect searches from the relicmore » DM annihilation into photons and neutrinos. We find that (i) the spin-independent (SI) blind spots may be rescued by the spin-dependent (SD) direct detection in the future underground experiments, and possibly by the indirect DM detections from IceCube and SuperK neutrino experiments; (ii) the detection of gamma rays from Fermi-LAT may not reach the desirable sensitivity for searching for the DM blind-spot regions; (iii) the SUSY searches at the LHC will substantially extend the discovery region for the blind-spot parameters. As a result, the dark matter blind spots thus may be unblinded with the collective efforts in future DM searches.« less

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.

Randomised Controlled Trial of a Parenting Intervention in the Voluntary Sector for Reducing Child Conduct Problems: Outcomes and Mechanisms of Change

ERIC Educational Resources Information Center

Gardner, Frances; Burton, Jennifer; Klimes, Ivana

2006-01-01

Background: To test effectiveness of a parenting intervention, delivered in a community-based voluntary-sector organisation, for reducing conduct problems in clinically-referred children. Methods: Randomised controlled trial, follow-up at 6, 18 months, assessors blind to treatment status. Participants--76 children referred for conduct problems,…

Prohibiting the use of funds available to any United States Government department or agency for the use of force in, or directed at, Syria by the United States Armed Forces.

THOMAS, 113th Congress

Rep. Poe, Ted [R-TX-2

2013-09-09

House - 09/09/2013 Referred to the Committee on Foreign Affairs, and in addition to the Committee on Armed Services, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Working and reference memory across the estrous cycle of rat: a long-term study in gonadally intact females.

PubMed

Pompili, Assunta; Tomaz, Carlos; Arnone, Benedetto; Tavares, Maria Clotilde; Gasbarri, Antonella

2010-11-12

The results of many studies conducted over the past two decades suggested a role of estrogen on mammal's ability to learn and remember. In the present paper, we analyzed the influence that the endogenous fluctuation of estrogen, naturally present across the different phases of estrous cycle of female rats, can exert over the performance of tasks utilized to assess memory. In particular, we analyzed the performances in an eight arms radial maze task, dependent upon working memory, and in a water maze (WM) task, dependent upon spatial reference memory. The water maze is aversively motivated by the desire to escape onto a safe platform, whereas the radial arm maze (RAM) is motivated by food reward. The difference in reinforcement may affect the speed of learning, the strategy adopted and the necessity for accurate navigation. Therefore, coherent results obtained through the two different tasks can be due to mnemonic factors. The study was conducted during a long period of time, 14 months, utilizing gonadally intact females, without pharmacological and surgical treatments. In order to evaluate the post-acquisition phase we first trained the animals to reach the criterion in performing tasks, and then we submitted them to experimental phase. Our results show that estrogen can have an effect on memory processes, and that this effect may be different in relation to different kinds of memory. In fact, in our study, estrogen selectively improved working memory, but not reference memory, during post-acquisition performance of a RAM task with four baited and four un-baited arms. Moreover, WM performances showed that estrogen have a negative effect on spatial reference memory. (c) 2010 Elsevier B.V. All rights reserved.

Action sounds update the mental representation of arm dimension: contributions of kinaesthesia and agency

PubMed Central

Tajadura-Jiménez, Ana; Tsakiris, Manos; Marquardt, Torsten; Bianchi-Berthouze, Nadia

2015-01-01

Auditory feedback accompanies almost all our actions, but its contribution to body-representation is understudied. Recently it has been shown that the auditory distance of action sounds recalibrates perceived tactile distances on one’s arm, suggesting that action sounds can change the mental representation of arm length. However, the question remains open of what factors play a role in this recalibration. In this study we investigate two of these factors, kinaesthesia, and sense of agency. Across two experiments, we asked participants to tap with their arm on a surface while extending their arm. We manipulated the tapping sounds to originate at double the distance to the tapping locations, as well as their synchrony to the action, which is known to affect feelings of agency over the sounds. Kinaesthetic cues were manipulated by having additional conditions in which participants did not displace their arm but kept tapping either close (Experiment 1) or far (Experiment 2) from their body torso. Results show that both the feelings of agency over the action sounds and kinaesthetic cues signaling arm displacement when displacement of the sound source occurs are necessary to observe changes in perceived tactile distance on the arm. In particular, these cues resulted in the perceived tactile distances on the arm being felt smaller, as compared to distances on a reference location. Moreover, our results provide the first evidence of consciously perceived changes in arm-representation evoked by action sounds and suggest that the observed changes in perceived tactile distance relate to experienced arm elongation. We discuss the observed effects in the context of forward internal models of sensorimotor integration. Our results add to these models by showing that predictions related to action sounds must fit with kinaesthetic cues in order for auditory inputs to change body-representation. PMID:26074843

Ethnicity and Deprivation are Associated With Blindness Among Adults With Primary Glaucoma in Nigeria: Results From the Nigeria National Blindness and Visual Impairment Survey.

PubMed

Kyari, Fatima; Wormald, Richard; Murthy, Gudlavalleti V S; Evans, Jennifer R; Gilbert, Clare E

2016-10-01

We explored the risk factors for glaucoma blindness among adults aged 40 years and above with primary glaucoma in Nigeria. A total of 13,591 participants aged 40 years and above were examined in the Nigeria Blindness Survey; 682 (5.02%; 95 CI, 4.60%-5.47%) had glaucoma by ISGEO's criteria. This was a case-control study (n=890 eyes of 629 persons): glaucoma blind persons were cases and glaucoma not-blind were controls. Education and occupation were used to determine socioeconomic status scores, which were divided into 3 tertiles (affluent, medium, deprived). We assessed sociodemographic, biophysical, and ocular factors by logistic regression analysis for association with glaucoma blindness. Multinomial regression analysis was also performed with nonglaucoma as the reference category. A total of 119/629 (18.9%; 95% CI, 15.9%-22.4%) persons were blind in both eyes; 510 were controls. There was interethnic variation in odds of blindness; age, male sex, socioeconomic status, prior diagnosis of glaucoma, hypertension, intraocular pressure, and lens opacity were associated with glaucoma blindness. Axial length, mean ocular perfusion pressure, and angle-closure glaucoma were associated with blind glaucoma eyes. In multivariate analysis, Igbo ethnicity (OR=2.79; 95% CI, 1.03-7.57) had higher risk as was being male (OR=4.59; 95% CI, 1.73-12.16) and unmarried (OR=2.50; 95% CI, 1.03-6.07). Deprivation (OR=3.57; 95% CI, 1.46-8.72), prior glaucoma diagnosis (OR=5.89; 95% CI, 1.79-19.40), and intraocular pressure (OR=1.07; 95% CI, 1.04-1.09) were also independent risk factors for glaucoma blindness. Approximately 1 in 5 people with primary glaucoma were blind. Male sex, ethnicity and deprivation were strongly associated with blindness. Services for glaucoma need to improve in Nigeria, focusing on poor communities and men.

Archimedes and the Magdeburg Hemispheres

ERIC Educational Resources Information Center

Hayn, Carl H.

1975-01-01

Weights suspended from a lever arm separate evacuated hemispheres allowing estimation of atmospheric pressure to within five percent of the barometric reading. An illustration and a reference to von Guericke's demonstration are provided. (GH)

Replantation (Finger, Hand, or Arm)

MedlinePlus

... is Replantation? Find a hand surgeon near you. Videos Figures Figure 1: Replantation refers to the surgical ... or "in." Also, avoid using media types like "video," "article," and "picture." Tip 4: Your results can ...

Boron neutron capture therapy for newly diagnosed glioblastoma multiforme: an assessment of clinical potential

PubMed Central

Sköld, K; Gorlia, T; Pellettieri, L; Giusti, V; H-Stenstam, B; Hopewell, J W

2010-01-01

The purpose of this study was to assess the potential of boron neutron capture therapy (BNCT), with a 6-h infusion of the boron carrier l-boronophenylalanine as a fructose preparation (BPA-f), as first-line radiotherapy for newly diagnosed glioblastoma multiforme (GBM). Patient survival data from a Phase II study using BNCT were compared with retrospective data from the two arms of a Phase III study using conventional radiotherapy (RT) in the reference arm and using RT plus concomitant and adjuvant medication with temozolomide (TMZ) in the experimental arm, and were also compared with small subgroups of these patients for whom the methylation status of the MGMT (O6-methylguanine–DNA methyltransferase) DNA repair gene was known. Differences in the baseline characteristics, salvage therapy after recurrence and levels of severe adverse events were also considered. The results indicate that BNCT offers a treatment that is at least as effective as conventional RT alone. For patients with an unmethylated MGMT DNA repair gene, a possible clinical advantage of BNCT over RT/TMZ was suggested. BNCT is a single-day treatment, which is of convenience to patients, with mild side effects, which would offer an initial 6 weeks of good-quality life during the time when patients would otherwise be undergoing daily treatments with RT and TMZ. It is suggested that the use of BNCT with a 6-h infusion of BPA-f should be explored in a stratified randomised Phase II trial in which patients with the unmethylated MGMT DNA repair gene are offered BNCT in the experimental arm and RT plus TMZ in the reference arm. PMID:20603410

Intraoperative Nerve Blocks Fail to Improve Quality of Recovery after Tissue Expander Breast Reconstruction: A Prospective, Double-Blinded, Randomized, Placebo-Controlled Clinical Trial.

PubMed

Lanier, Steven T; Lewis, Kevin C; Kendall, Mark C; Vieira, Brittany L; De Oliveira, Gildasio; Nader, Anthony; Kim, John Y S; Alghoul, Mohammed

2018-03-01

The authors' study represents the first level I evidence to assess whether intraoperative nerve blocks improve the quality of recovery from immediate tissue expander/implant breast reconstruction. A prospective, randomized, double-blinded, placebo-controlled clinical trial was conducted in which patients undergoing immediate tissue expander/implant breast reconstruction were randomized to either (1) intraoperative intercostal and pectoral nerve blocks with 0.25% bupivacaine with 1:200,000 epinephrine and 4 mg of dexamethasone or (2) sham nerve blocks with normal saline. The 40-item Quality of Recovery score, pain score, and opioid use in the postoperative period were compared statistically between groups. Power analysis ensured 80 percent power to detect a 10-point (clinically significant) difference in the 40-item Quality of Recovery score. Forty-seven patients were enrolled. Age, body mass index, laterality, mastectomy type, and lymph node dissection were similar between groups. There were no statistical differences in quality of recovery, pain burden as measured by visual analogue scale, opioid consumption, antiemetic use, or length of hospital stay between groups at 24 hours after surgery. Mean global 40-item Quality of Recovery scores were 169 (range, 155 to 182) for the treatment arm and 165 (range, 143 to 179) for the placebo arm (p = 0.36), indicating a high quality of recovery in both groups. Although intraoperative nerve blocks can be a safe adjunct to a comprehensive postsurgical recovery regimen, the authors' results indicate no effect on overall quality of recovery from tissue expander/implant breast reconstruction. Therapeutic, I.

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.

The 12-month analysis from Basal Cell Carcinoma Outcomes with LDE225 Treatment (BOLT): A phase II, randomized, double-blind study of sonidegib in patients with advanced basal cell carcinoma.

PubMed

Dummer, Reinhard; Guminski, Alexander; Gutzmer, Ralf; Dirix, Luc; Lewis, Karl D; Combemale, Patrick; Herd, Robert M; Kaatz, Martin; Loquai, Carmen; Stratigos, Alexander J; Schulze, Hans-Joachim; Plummer, Ruth; Gogov, Sven; Pallaud, Celine; Yi, Tingting; Mone, Manisha; Chang, Anne Lynn S; Cornélis, Frank; Kudchadkar, Ragini; Trefzer, Uwe; Lear, John T; Sellami, Dalila; Migden, Michael R

2016-07-01

The hedgehog pathway inhibitor sonidegib demonstrated meaningful tumor shrinkage in more than 90% of patients with locally advanced basal cell carcinoma (BCC) or metastatic BCC in the BCC Outcomes with LDE225 Treatment study. This report provides long-term follow-up data collected up to 12 months after the last patient was randomized. In this multicenter, randomized, double-blind phase II study, patients were randomized 1:2 to sonidegib 200 or 800 mg. The primary end point was objective response rate assessed by central review. Objective response rates in the 200- and 800-mg arms were 57.6% and 43.8% in locally advanced BCC and 7.7% and 17.4% in metastatic BCC, respectively. Among the 94 patients with locally advanced BCC who responded, only 18 progressed or died and more than 50% had responses lasting longer than 6 months. In addition, 4 of 5 responders with metastatic BCC maintained an objective response. Grade 3/4 adverse events and those leading to discontinuation were less frequent with sonidegib 200 versus 800 mg (38.0% vs 59.3%; 27.8% vs 37.3%, respectively). No placebo or comparator arms were used because sonidegib demonstrated efficacy in advanced BCC in a phase I study, and the hedgehog pathway inhibitor vismodegib was not yet approved. With longer follow-up, sonidegib demonstrated sustained tumor responses in patients with advanced BCC. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Randomized single-blind clinical trial of intradermal methylene blue on pain reduction after open diathermy haemorrhoidectomy.

PubMed

Sim, H-L; Tan, K-Y

2014-08-01

Open haemorrhoidectomy has been associated with considerable postoperative pain and discomfort. Perianal intradermal injection of methylene blue has been shown to ablate perianal nerve endings and may bring about temporary pain relief after haemorrhoidectomy. We hypothesized that the administration of intradermal methylene blue would reduce postoperative pain during the initial period after surgery. A randomized, prospective, single-blind placebo-controlled trial was conducted. Patients were randomized to intradermal injection at haemorrhoidectomy of either 4 ml 1% methylene blue and 16 ml 0.5% marcaine or of 16 ml 0.5% marcaine and 4 ml saline prior to surgical dissection. Patients were asked to fill in a pain diary with a visual analogue scale. The primary outcome measure was pain score and analgesic use. Secondary outcomes were complications. There were 37 patients in the methylene blue arm and 30 patients in the placebo arm. There were no statistically significant differences in the sex, type of haemorrhoid, number of haemorrhoids excised, duration of surgery or hospital stay. The mean pain scores were significantly lower and the use of paracetamol was also significantly less in the methylene blue group during the first three postoperative days. The risk ratio of acute urinary retention occurring when methylene blue was not used was 2.320 (95% CI 1.754-3.067). Other complication rates were not significantly different. Perianal intradermal injection of methylene blue was useful in reducing the initial postoperative pain of open haemorrhoidectomy. Colorectal Disease © 2014 The Association of Coloproctology of Great Britain and Ireland.

Study protocol of Prednisone in episodic Cluster Headache (PredCH): a randomized, double-blind, placebo-controlled parallel group trial to evaluate the efficacy and safety of oral prednisone as an add-on therapy in the prophylactic treatment of episodic cluster headache with verapamil

PubMed Central

2013-01-01

Background Episodic cluster headache (ECH) is a primary headache disorder that severely impairs patient’s quality of life. First-line therapy in the initiation of a prophylactic treatment is verapamil. Due to its delayed onset of efficacy and the necessary slow titration of dosage for tolerability reasons prednisone is frequently added by clinicians to the initial prophylactic treatment of a cluster episode. This treatment strategy is thought to effectively reduce the number and intensity of cluster attacks in the beginning of a cluster episode (before verapamil is effective). This study will assess the efficacy and safety of oral prednisone as an add-on therapy to verapamil and compare it to a monotherapy with verapamil in the initial prophylactic treatment of a cluster episode. Methods and design PredCH is a prospective, randomized, double-blind, placebo-controlled trial with parallel study arms. Eligible patients with episodic cluster headache will be randomized to a treatment intervention with prednisone or a placebo arm. The multi-center trial will be conducted in eight German headache clinics that specialize in the treatment of ECH. Discussion PredCH is designed to assess whether oral prednisone added to first-line agent verapamil helps reduce the number and intensity of cluster attacks in the beginning of a cluster episode as compared to monotherapy with verapamil. Trial registration German Clinical Trials Register DRKS00004716 PMID:23889923

Vitamin D as supplementary treatment for tuberculosis: a double-blind, randomized, placebo-controlled trial.

PubMed

Wejse, Christian; Gomes, Victor F; Rabna, Paulo; Gustafson, Per; Aaby, Peter; Lisse, Ida M; Andersen, Paul L; Glerup, Henning; Sodemann, Morten

2009-05-01

Vitamin D has been shown to be involved in the host immune response toward Mycobacterium tuberculosis. To test whether vitamin D supplementation of patients with tuberculosis (TB) improved clinical outcome and reduced mortality. We conducted a randomized, double-blind, placebo-controlled trial in TB clinics at a demographic surveillance site in Guinea-Bissau. We included 365 adult patients with TB starting antituberculosis treatment; 281 completed the 12-month follow-up. The intervention was 100,000 IU of cholecalciferol or placebo at inclusion and again 5 and 8 months after the start of treatment. The primary outcome was reduction in a clinical severity score (TBscore) for all patients with pulmonary TB. The secondary outcome was 12-month mortality. No serious adverse effects were reported; mild hypercalcemia was rare and present in both arms. Reduction in TBscore and sputum smear conversion rates did not differ among patients treated with vitamin D or placebo. Overall mortality was 15% (54 of 365) at 1 year of follow-up and similar in both arms (30 of 187 for vitamin D treated and 24 of 178 for placebo; relative risk, 1.19 [0.58-1.95]). HIV infection was seen in 36% (131 of 359): 21% (76 of 359) HIV-1, 10% (36 of 359) HIV-2, and 5% (19 of 357) HIV-1+2. Vitamin D does not improve clinical outcome among patients with TB and the trial showed no overall effect on mortality in patients with TB; it is possible that the dose used was insufficient. Clinical trial registered with www.controlled-trials.com/isrctn (ISRCTN35212132).

Mirror therapy in children with hemiparesis: a randomized observer-blinded trial.

PubMed

Bruchez, Roselyn; Jequier Gygax, Marine; Roches, Sylvie; Fluss, Joel; Jacquier, David; Ballabeni, Pierluigi; Grunt, Sebastian; Newman, Christopher J

2016-09-01

To determine the efficacy of mirror therapy in children with hemiparesis. The design was an observer-blinded parallel-group randomized controlled trial (International Standard Randomised Controlled Trial Number 48748291). Randomization was computer-generated, 1:1 allocation to mirror therapy or comparison groups. The settings were home-based intervention and tertiary centre assessments. Participants were 90 children with hemiparesis aged 7 to 17 years. Intervention was 15 minutes per day of simultaneous arm training, 5 days a week, for 5 weeks. The mirror therapy group used a mirror; those in the comparison group looked at their paretic limb. Assessments comprised measures of upper limb strength, function (Melbourne Assessment 2), daily performance (ABILHAND-Kids), and sensory function at weeks 0 (T0 ), 5 (T1 ), and 10 (T2 ). There were no significant differences in outcomes and their progression over time between the mirror therapy and comparison groups. Post-hoc intention-to-treat analyses showed significant improvements in both groups for grasp strength (T0 -T1 +12.6%), pinch strength (T0 -T2 +9.1%), upper limb function in terms of accuracy (T0 -T2 +2.7%) and fluency (T0 -T2 +5.0%), as well as daily performance (T0 -T2 +16.6%). Per protocol analyses showed additional improvements in dexterity (T0 -T2 +4.0%). The use of the mirror illusion during therapy had no significant effect on treatment outcomes. However, 5 weeks of daily simultaneous arm training significantly improved paretic upper limb strength, function, and daily use. © 2016 Mac Keith Press.

Using the STROBE statement to assess reporting in blindness prevalence surveys in low and middle income countries.

PubMed

Ramke, Jacqueline; Palagyi, Anna; Jordan, Vanessa; Petkovic, Jennifer; Gilbert, Clare E

2017-01-01

Cross-sectional blindness prevalence surveys are essential to plan and monitor eye care services. Incomplete or inaccurate reporting can prevent effective translation of research findings. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement is a 32 item checklist developed to improve reporting of observational studies. The aim of this study was to assess the completeness of reporting in blindness prevalence surveys in low and middle income countries (LMICs) using STROBE. MEDLINE, EMBASE and Web of Science databases were searched on April 8 2016 to identify cross-sectional blindness prevalence surveys undertaken in LMICs and published after STROBE was published in December 2007. The STROBE tool was applied to all included studies, and each STROBE item was categorized as 'yes' (met criteria), 'no' (did not meet criteria) or 'not applicable'. The 'Completeness of reporting (COR) score' for each manuscript was calculated: COR score = yes / [yes + no]. In journals with included studies the instructions to authors and reviewers were checked for reference to STROBE. The 89 included studies were undertaken in 32 countries and published in 37 journals. The mean COR score was 60.9% (95% confidence interval [CI] 58.1-63.7%; range 30.8-88.9%). The mean COR score did not differ between surveys published in journals with author instructions referring to STROBE (10/37 journals; 61.1%, 95%CI 56.4-65.8%) or in journals where STROBE was not mentioned (60.9%, 95%CI 57.4-64.3%; p = 0.93). While reporting in blindness prevalence surveys is strong in some areas, others need improvement. We recommend that more journals adopt the STROBE checklist and ensure it is used by authors and reviewers.

Oscillatory activity reflects differential use of spatial reference frames by sighted and blind individuals in tactile attention.

PubMed

Schubert, Jonathan T W; Buchholz, Verena N; Föcker, Julia; Engel, Andreas K; Röder, Brigitte; Heed, Tobias

2015-08-15

Touch can be localized either on the skin in anatomical coordinates, or, after integration with posture, in external space. Sighted individuals are thought to encode touch in both coordinate systems concurrently, whereas congenitally blind individuals exhibit a strong bias for using anatomical coordinates. We investigated the neural correlates of this differential dominance in the use of anatomical and external reference frames by assessing oscillatory brain activity during a tactile spatial attention task. The EEG was recorded while sighted and congenitally blind adults received tactile stimulation to uncrossed and crossed hands while detecting rare tactile targets at one cued hand only. In the sighted group, oscillatory alpha-band activity (8-12Hz) in the cue-target interval was reduced contralaterally and enhanced ipsilaterally with uncrossed hands. Hand crossing attenuated the degree of posterior parietal alpha-band lateralization, indicating that attention deployment was affected by external spatial coordinates. Beamforming suggested that this posture effect originated in the posterior parietal cortex. In contrast, cue-related lateralization of central alpha-band as well as of beta-band activity (16-24Hz) were unaffected by hand crossing, suggesting that these oscillations exclusively encode anatomical coordinates. In the blind group, central alpha-band activity was lateralized, but did not change across postures. The pattern of beta-band activity was indistinguishable between groups. Because the neural mechanisms for posterior alpha-band generation seem to be linked to developmental vision, we speculate that the lack of this neural mechanism in blind individuals is related to their preferred use of anatomical over external spatial codes in sensory processing. Copyright © 2015 Elsevier Inc. All rights reserved.

Clinical and radiological outcomes of 5-year drug-free remission-steered treatment in patients with early arthritis: IMPROVED study.

PubMed

Akdemir, Gülşah; Heimans, Lotte; Bergstra, Sytske Anne; Goekoop, Robbert J; van Oosterhout, Maikel; van Groenendael, Johannes H L M; Peeters, André J; Steup-Beekman, Gerda M; Lard, Leroy R; de Sonnaville, Peter B J; Grillet, Bernard A M; Huizinga, Tom W J; Allaart, Cornelia F

2018-01-01

To determine the 5-year outcomes of early remission induction therapy followed by targeted treatment aimed at drug-free remission (DFR) in patients with early arthritis. In 12 hospitals, 610 patients with early (<2 years) rheumatoid arthritis (RA) or undifferentiated arthritis (UA) started on methotrexate (MTX) 25 mg/week and prednisone (60 mg/day tapered to 7.5 mg/day). Patients not in early remission (Disease Activity Score <1.6 after 4 months) were randomised (single blind) to arm 1, adding hydroxychloroquine 400 mg/day and sulfasalazine 2000 mg/day, or arm 2, switching to MTX plus adalimumab 40 mg/2 weeks. Treatment adjustments over time aimed at DFR. Outcomes were remission percentages, functional ability, toxicity and radiological damage progression after 5 years. After 4 months, 387 patients were in early remission, 83 were randomised to arm 1 and 78 to arm 2. After 5 years, 295/610 (48%) patients were in remission, 26% in sustained DFR (SDFR) (≥1 year) (220/387 (57%) remission and 135/387 (35%) SDFR in the early remission group, 50% remission, 11% SDFR in the randomisation arms without differences between the arms). More patients with UA (37% vs 23% RA, p=0.001) and more anticitrullinated protein antibody (ACPA)-negative patients (37% vs 18% ACPA-positive, p<0.001) achieved SDFR.Overall, mean Health Assessment Questionnaire was 0.6 (0.5), and median (IQR) damage progression was 0.5 (0-2.7) Sharp/van der Heijde points, with only five patients showing progression >25 points in 5 years. Five years of DFR-steered treatment in patients with early RA resulted in almost normal functional ability without clinically relevant joint damage across treatment groups. Patients who achieved early remission had the best clinical outcomes. There were no differences between the randomisation arms. SDFR is a realistic treatment goal. © 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.

A randomized controlled trial of very early rehabilitation in speech after stroke.

PubMed

Godecke, Erin; Armstrong, Elizabeth A; Rai, Tapan; Middleton, Sandy; Ciccone, Natalie; Whitworth, Anne; Rose, Miranda; Holland, Audrey; Ellery, Fiona; Hankey, Graeme J; Cadilhac, Dominique A; Bernhardt, Julie

2016-07-01

The efficacy of rehabilitation therapy for aphasia caused by stroke is uncertain. The Very Early Rehabilitation of Speech (VERSE) trial aims to determine if intensive prescribed aphasia therapy (VERSE) is more effective and cost saving than non-prescribed, intensive (usual care-plus) and non-intensive usual care (UC) therapy when started within 15 days of stroke onset and continued daily over four weeks. We hypothesize that aphasia therapy when started very early after stroke and delivered daily could enhance recovery of communication compared with UC. A total of 246 participants (82 per arm) will provide 80% power to detect a 4.4% improvement on aphasia quotient between VERSE and UC plus at a significance level of α = 0.05. Acute-care hospitals and accompanying rehabilitation services throughout Australia, 2014-2017. Three-arm, prospective, randomized, parallel group, open-label, blinded endpoint assessment (PROBE) trial. Acute stroke in previous 14 days and aphasia diagnosed by aphasia quotient (AQ) of the Western Aphasia Battery (WAB). Computer-generated blocked randomization procedure stratified by aphasia severity according to Western Aphasia Battery, to one of three arms. All participants receive UC-usual ward-based aphasia therapy. Arm 1: UC-no additional therapy; Arm 2: UC-plus usual ward-based therapy; Arm 3: VERSE therapy-a prescribed and structured aphasia therapy program. Arms 2 and 3 receive a total of 20 additional sessions (45-60 min, provided daily) of aphasia therapy. The additional intervention must be provided before day 50 post stroke. The aphasia quotient of Western Aphasia Battery at 12 weeks post stroke. Secondary outcomes include discourse measures, the Stroke and Aphasia Quality of Life Scale-39 and the Aphasia Depression Rating Scale at 12 and 26 weeks. Incremental cost-effectiveness ratios at 26 weeks will be reported. This trial is designed to test whether the intensive and prescribed VERSE intervention is effective in promoting maximum recovery and preventing costly health complications in a vulnerable population of survivors of stroke. It will also provide novel, prospective, aphasia specific cost-effectiveness data to guide future policy development for this population. © 2016 World Stroke Organization.

Effects of rivastigmine on visual attention in subjects with amnestic mild cognitive impairment: A serial functional MRI activation pilot-study.

PubMed

Bokde, Arun L W; Cavedo, Enrica; Lopez-Bayo, Patricia; Lista, Simone; Meindl, Thomas; Born, Christine; Galluzzi, Samantha; Faltraco, Frank; Dubois, Bruno; Teipel, Stefan J; Reiser, Maximilian; Möller, Hans-Jürgen; Hampel, Harald

2016-03-30

A pilot study to investigate the effects of rivastigmine on the brain activation pattern due to visual attention tasks in a group of amnestic Mild Cognitive Impaired patients (aMCI). The design was an initial three-month double blind period with a rivastigmine and placebo arms, followed by a nine-month open-label period. All patients underwent serial functional magnetic resonance imaging (fMRI) at baseline, and after three and six months of follow-up. Primary endpoint was the effect of rivastigmine on functional brain changes during visual attention (face and location matching) tasks. There were five in the rivastigmine arm and two in the placebo arm. The face matching task showed higher activation of visual areas after three months of treatment but no differences compared to baseline at six months. The location matching task showed a higher activation along the dorsal visual pathway at both three and six months follow ups. Treatment with rivastigmine demonstrates a significant effect on brain activation of the dorsal visual pathway during a location matching task in patients with aMCI. Our data support the potential use of task fMRI to map specific treatment effects of cholinergic drugs during prodromal stages of Alzheimer's disease (AD). Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

The Cardiac Safety Research Consortium ECG database.

PubMed

Kligfield, Paul; Green, Cynthia L

2012-01-01

The Cardiac Safety Research Consortium (CSRC) ECG database was initiated to foster research using anonymized, XML-formatted, digitized ECGs with corresponding descriptive variables from placebo- and positive-control arms of thorough QT studies submitted to the US Food and Drug Administration (FDA) by pharmaceutical sponsors. The database can be expanded to other data that are submitted directly to CSRC from other sources, and currently includes digitized ECGs from patients with genotyped varieties of congenital long-QT syndrome; this congenital long-QT database is also linked to ambulatory electrocardiograms stored in the Telemetric and Holter ECG Warehouse (THEW). Thorough QT data sets are available from CSRC for unblinded development of algorithms for analysis of repolarization and for blinded comparative testing of algorithms developed for the identification of moxifloxacin, as used as a positive control in thorough QT studies. Policies and procedures for access to these data sets are available from CSRC, which has developed tools for statistical analysis of blinded new algorithm performance. A recently approved CSRC project will create a data set for blinded analysis of automated ECG interval measurements, whose initial focus will include comparison of four of the major manufacturers of automated electrocardiographs in the United States. CSRC welcomes application for use of the ECG database for clinical investigation. Copyright © 2012 Elsevier Inc. All rights reserved.

Genetics Home Reference: Buschke-Ollendorff syndrome

MedlinePlus

... example, a small percentage of affected individuals have melorheostosis , which is characterized by excess bone growth on ... bones in a pattern resembling dripping candle wax. Melorheostosis usually affects the bones in one arm or ...

Anthropometric sourcebook

NASA Technical Reports Server (NTRS)

Bond, R. L.; Jackson, J. T.; Louviere, A. J.; Thornton, W. E.

1979-01-01

Three-volume "Anthropometric Source Book' contains large body of anthropometric data, design information, and references. Subjects covered include variability in body size, mass distribution properties of human body, arm and leg reach, joint motion and numerous other materials.

Genetics Home Reference: facioscapulohumeral muscular dystrophy

MedlinePlus

... those of the face (facio-), around the shoulder blades (scapulo-), and in the upper arms (humeral). The ... Weak shoulder muscles tend to make the shoulder blades (scapulae) protrude from the back, a common sign ...

[Ethyl chloride aerosol spray for local anesthesia before arterial puncture: randomized placebo-controlled trial].

PubMed

Ballesteros-Peña, Sendoa; Fernández-Aedo, Irrintzi; Vallejo-De la Hoz, Gorka

2017-06-01

To compare the efficacy of an ethyl chloride aerosol spray to a placebo spray applied in the emergency department to the skin to reduce pain from arterial puncture for blood gas analysis. Single-blind, randomized placebo-controlled trial in an emergency department of Hospital de Basurto in Bilbao, Spain. We included 126 patients for whom arterial blood gas analysis had been ordered. They were randomly assigned to receive application of the experimental ethyl chloride spray (n=66) or a placebo aerosol spray of a solution of alcohol in water (n=60). The assigned spray was applied just before arterial puncture. The main outcome variable was pain intensity reported on an 11-point numeric rating scale. The median (interquartile range) pain level was 2 (1-5) in the experimental arm and 2 (1-4.5) in the placebo arm (P=.72). Topical application of an ethyl chloride spray did not reduce pain caused by arterial puncture.

Linkage analysis in a Dutch family with X-linked recessive congenital stationary night blindness (XL-CSNB).

PubMed

Berger, W; van Duijnhoven, G; Pinckers, A; Smits, A; Ropers, H H; Cremers, F

1995-01-01

Linkage analysis has been performed in a large Dutch pedigree with X-linked recessive congenital stationary night blindness (CSNB) by utilizing 16 DNA markers from the proximal short arm of the human X chromosome (Xp21.1-11.2). Thirteen polymorphic markers are at least partially informative and have enabled pairwise and multipoint linkage analysis. For three loci, i.e. DXS228, the monoamine oxidase B gene and the Norrie disease gene (NDG), multipoint linkage studies have yielded maximum lod scores of > 3.0 at a recombination fraction of zero. Analysis of recombination events has enabled us to rule out the possibility that the underlying defect in this family is allelic to RP3; the gene defect could also be excluded from the proximal part of the region known to carry RP2. Linkage data are consistent with a possible involvement of the NDG but mutations in the open reading frame of this gene have not been found.

Effects of amphetamine and/or L-dopa and physiotherapy after stroke - a blinded randomized study.

PubMed

Sonde, L; Lökk, J

2007-01-01

Major therapeutic advances in the rehabilitation of subacute stroke are lacking. A promising approach is treatment with facilitating drugs like amphetamine or levodopa in combination with physiotherapy. In a randomized, double-blind, placebo-controlled clinical trail, the effect of 10 sessions with either 20 mg of D-amphetamine, 100 mg of L-dopa or 10 mg of D-amphetamine + 50 mg of L-dopa combined with physiotherapy during a 2-week period was investigated in 25 patients admitted to a stroke rehabilitation unit. Motor function (Fugl-Meyer score) and activities of daily living (Barthel's index) were assessed. All patients improved significantly over the intervention period. Drug-treated patients did not show any additional increase in motor function or ADL. It is feasible and safe to perform larger clinical trials with this type of four-arm design. However, the lack of significant effects could be because of type, dosage, and time of drugs as well as the physical intervention strategy.

[Not Available].

PubMed

2004-06-01

St Dunstan's, the charity for blind ex-Service men and women, is commemorating this month's 60th anniversary of the D-Day landings with a spectacular rocket and light display linking all the towns and cities along the south coast that participated in the D-Day departures. Embarkation for the biggest military invasion of World War Two began on June 2 1944 on the beaches of Falmouth. Among the 'St Dunstaners' who took part were Fred Bentley (pictured left, with a guide) who, as a 20-year-old, was blinded when a German grenade exploded in front of him during the battle for Caen in northern France after the Allied invasion. Also pictured (inset) is Bob Osborne who was in the first wave of troops landing on the Normandy beaches. He, too, was 20 at the time and lost a leg, an arm and his sight under fire from enemy tanks. For many years he ran the newsagent at St Dunstan's main centre for training, rehabilitation and support near Brighton.

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.

Anthropometry of height, weight, arm, wrist, abdominal circumference and body mass index, for Bolivian adolescents 12 to 18 years: Bolivian adolescent percentile values from the MESA study.

PubMed

Baya Botti, A; Pérez-Cueto, F J A; Vasquez Monllor, P A; Kolsteren, P W

2009-01-01

Anthropometry is important as clinical tool for individual follow-up as well as for planning and health policy-making at population level. Recent references of Bolivian Adolescents are not available. The aim of this cross sectional study was to provide age and sex specific centile values and charts of Body Mass Index, height, weight, arm, wrist and abdominal circumference from Bolivian Adolescents. Data from the MEtabolic Syndrome in Adolescents (MESA) study was used. Thirty-two Bolivian clusters from urban and rural areas were selected randomly considering population proportions, 3445 school going adolescents, 12 to 18 y, 45% males; 55% females underwent anthropometric evaluation by trained personnel using standardized protocols for all interviews and examinations. Weight, height, wrist, arm and abdominal circumference data were collected. Body Mass Index was calculated. Smoothed age- and gender specific 3rd, 5th, 10th, 25th, 50th, 75th, 85th, 90th, 95th and 97th Bolivian adolescent percentiles(BAP) and Charts(BAC) where derived using LMS regression. Percentile-based reference data for the antropometrics of for Bolivian Adolescents are presented for the first time.

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

Thorpe, J. I.; Livas, J.; Maghami, P.

Arm locking is a proposed laser frequency stabilization technique for the Laser Interferometer Space Antenna (LISA), a gravitational-wave observatory sensitive in the milliHertz frequency band. Arm locking takes advantage of the geometric stability of the triangular constellation of three spacecraft that compose LISA to provide a frequency reference with a stability in the LISA measurement band that exceeds that available from a standard reference such as an optical cavity or molecular absorption line. We have implemented a time-domain simulation of a Kalman-filter-based arm-locking system that includes the expected limiting noise sources as well as the effects of imperfect a priorimore » knowledge of the constellation geometry on which the design is based. We use the simulation to study aspects of the system performance that are difficult to capture in a steady-state frequency-domain analysis such as frequency pulling of the master laser due to errors in estimates of heterodyne frequency. We find that our implementation meets requirements on both the noise and dynamic range of the laser frequency with acceptable tolerances and that the design is sufficiently insensitive to errors in the estimated constellation geometry that the required performance can be maintained for the longest continuous measurement intervals expected for the LISA mission.« less

Motor contingency learning and infants with Spina Bifida.

PubMed

Taylor, Heather B; Barnes, Marcia A; Landry, Susan H; Swank, Paul; Fletcher, Jack M; Huang, Furong

2013-02-01

Infants with Spina Bifida (SB) were compared to typically developing infants (TD) using a conjugate reinforcement paradigm at 6 months-of-age (n = 98) to evaluate learning, and retention of a sensory-motor contingency. Analyses evaluated infant arm-waving rates at baseline (wrist not tethered to mobile), during acquisition of the sensory-motor contingency (wrist tethered), and immediately after the acquisition phase and then after a delay (wrist not tethered), controlling for arm reaching ability, gestational age, and socioeconomic status. Although both groups responded to the contingency with increased arm-waving from baseline to acquisition, 15% to 29% fewer infants with SB than TD were found to learn the contingency depending on the criterion used to determine contingency learning. In addition, infants with SB who had learned the contingency had more difficulty retaining the contingency over time when sensory feedback was absent. The findings suggest that infants with SB do not learn motor contingencies as easily or at the same rate as TD infants, and are more likely to decrease motor responses when sensory feedback is absent. Results are discussed with reference to research on contingency learning in infants with and without neurodevelopmental disorders, and with reference to motor learning in school-age children with SB.

Genetics Home Reference: Lenz microphthalmia syndrome

MedlinePlus

... eyeballs that are abnormally small ( microphthalmia ) or absent (anophthalmia), leading to vision loss or blindness. Other eye ... Lenz dysplasia Lenz syndrome MAA MCOPS1 microphthalmia or anophthalmos with associated anomalies microphthalmia, syndromic 1 Related Information ...

Genetics Home Reference: Costeff syndrome

MedlinePlus

... Foundation for the Blind Jewish Genetic Disease Consortium Organic Acidemia Association Resource List from the University of ... 1016/j.ymgme.2010.03.005. Epub 2010 Mar 16. Citation on PubMed or Free article on ...

Genetics Home Reference: encephalocraniocutaneous lipomatosis

MedlinePlus

... PubMed or Free article on PubMed Central Hunter AG. Oculocerebrocutaneous and encephalocraniocutaneous lipomatosis syndromes: blind men and ... qualified healthcare professional . About Selection Criteria for Links Data Files & API Site Map Subscribe Customer Support USA. ...

Development and Feasibility Assessment of a Rotational Orthosis for Walking with Arm Swing.

PubMed

Fang, Juan; Xie, Qing; Yang, Guo-Yuan; Xie, Le

2017-01-01

Interlimb neural coupling might underlie human bipedal locomotion, which is reflected in the fact that people swing their arms synchronously with leg movement in normal gait. Therefore, arm swing should be included in gait training to provide coordinated interlimb performance. The present study aimed to develop a Rotational Orthosis for Walking with Arm Swing (ROWAS), and evaluate its feasibility from the perspectives of implementation, acceptability and responsiveness. We developed the mechanical structures of the ROWAS system in SolidWorks, and implemented the concept in a prototype. Normal gait data were used as the reference performance of the shoulder, hip, knee and ankle joints of the prototype. The ROWAS prototype was tested for function assessment and further evaluated using five able-bodied subjects for user feedback. The ROWAS prototype produced coordinated performance in the upper and lower limbs, with joint profiles similar to those occurring in normal gait. The subjects reported a stronger feeling of walking with arm swing than without. The ROWAS system was deemed feasible according to the formal assessment criteria.

Development and Feasibility Assessment of a Rotational Orthosis for Walking with Arm Swing

PubMed Central

Fang, Juan; Xie, Qing; Yang, Guo-Yuan; Xie, Le

2017-01-01

Interlimb neural coupling might underlie human bipedal locomotion, which is reflected in the fact that people swing their arms synchronously with leg movement in normal gait. Therefore, arm swing should be included in gait training to provide coordinated interlimb performance. The present study aimed to develop a Rotational Orthosis for Walking with Arm Swing (ROWAS), and evaluate its feasibility from the perspectives of implementation, acceptability and responsiveness. We developed the mechanical structures of the ROWAS system in SolidWorks, and implemented the concept in a prototype. Normal gait data were used as the reference performance of the shoulder, hip, knee and ankle joints of the prototype. The ROWAS prototype was tested for function assessment and further evaluated using five able-bodied subjects for user feedback. The ROWAS prototype produced coordinated performance in the upper and lower limbs, with joint profiles similar to those occurring in normal gait. The subjects reported a stronger feeling of walking with arm swing than without. The ROWAS system was deemed feasible according to the formal assessment criteria. PMID:28203142

An iPhone application for upper arm posture and movement measurements.

PubMed

Yang, Liyun; Grooten, Wilhelmus J A; Forsman, Mikael

2017-11-01

There is a need for objective methods for upper arm elevation measurements for accurate and convenient risk assessments. The aims of this study were (i) to compare a newly developed iOS application (iOS) for measuring upper arm elevation and angular velocity with a reference optical tracking system (OTS), and (ii) to compare the accuracy of the iOS incorporating a gyroscope and an accelerometer with using only an accelerometer, which is standard for inclinometry. The iOS-OTS limits of agreement for static postures (9 subjects) were -4.6° and 4.8°. All root mean square differences in arm swings and two simulated work tasks were <6.0°, and all mean correlation coefficients were >0.98. The mean absolute iOS-OTS difference of median angular velocity was <13.1°/s, which was significantly lower than only using an accelerometer (<43.5°/s). The accuracy of this iOS application compares well to that of today's research methods and it can be useful for practical upper arm measurements. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Large-aperture interferometer using local reference beam

NASA Technical Reports Server (NTRS)

Howes, W. L.

1982-01-01

A large-aperture interferometer was devised by adding a local-reference-beam-generating optical system to a schlieren system. Two versions of the interferometer are demonstrated, one employing 12.7 cm (5 in.) diameter schlieren optics, the other employing 30.48 cm (12 in.) diameter parabolic mirrors in an off-axis system. In the latter configuration a cylindrical lens is introduced near the light source to correct for astigmatism. A zone plate is a satisfactory decollimating element in the reference-beam arm of the interferometer. Attempts to increase the flux and uniformity of irradiance in the reference beam by using a diffuser are discussed.

Blind Source Parameters for Performance Evaluation of Despeckling Filters.

PubMed

Biradar, Nagashettappa; Dewal, M L; Rohit, ManojKumar; Gowre, Sanjaykumar; Gundge, Yogesh

2016-01-01

The speckle noise is inherent to transthoracic echocardiographic images. A standard noise-free reference echocardiographic image does not exist. The evaluation of filters based on the traditional parameters such as peak signal-to-noise ratio, mean square error, and structural similarity index may not reflect the true filter performance on echocardiographic images. Therefore, the performance of despeckling can be evaluated using blind assessment metrics like the speckle suppression index, speckle suppression and mean preservation index (SMPI), and beta metric. The need for noise-free reference image is overcome using these three parameters. This paper presents a comprehensive analysis and evaluation of eleven types of despeckling filters for echocardiographic images in terms of blind and traditional performance parameters along with clinical validation. The noise is effectively suppressed using the logarithmic neighborhood shrinkage (NeighShrink) embedded with Stein's unbiased risk estimation (SURE). The SMPI is three times more effective compared to the wavelet based generalized likelihood estimation approach. The quantitative evaluation and clinical validation reveal that the filters such as the nonlocal mean, posterior sampling based Bayesian estimation, hybrid median, and probabilistic patch based filters are acceptable whereas median, anisotropic diffusion, fuzzy, and Ripplet nonlinear approximation filters have limited applications for echocardiographic images.

Blind prediction of natural video quality.

PubMed

Saad, Michele A; Bovik, Alan C; Charrier, Christophe

2014-03-01

We propose a blind (no reference or NR) video quality evaluation model that is nondistortion specific. The approach relies on a spatio-temporal model of video scenes in the discrete cosine transform domain, and on a model that characterizes the type of motion occurring in the scenes, to predict video quality. We use the models to define video statistics and perceptual features that are the basis of a video quality assessment (VQA) algorithm that does not require the presence of a pristine video to compare against in order to predict a perceptual quality score. The contributions of this paper are threefold. 1) We propose a spatio-temporal natural scene statistics (NSS) model for videos. 2) We propose a motion model that quantifies motion coherency in video scenes. 3) We show that the proposed NSS and motion coherency models are appropriate for quality assessment of videos, and we utilize them to design a blind VQA algorithm that correlates highly with human judgments of quality. The proposed algorithm, called video BLIINDS, is tested on the LIVE VQA database and on the EPFL-PoliMi video database and shown to perform close to the level of top performing reduced and full reference VQA algorithms.

Blind Source Parameters for Performance Evaluation of Despeckling Filters

PubMed Central

Biradar, Nagashettappa; Dewal, M. L.; Rohit, ManojKumar; Gowre, Sanjaykumar; Gundge, Yogesh

2016-01-01

The speckle noise is inherent to transthoracic echocardiographic images. A standard noise-free reference echocardiographic image does not exist. The evaluation of filters based on the traditional parameters such as peak signal-to-noise ratio, mean square error, and structural similarity index may not reflect the true filter performance on echocardiographic images. Therefore, the performance of despeckling can be evaluated using blind assessment metrics like the speckle suppression index, speckle suppression and mean preservation index (SMPI), and beta metric. The need for noise-free reference image is overcome using these three parameters. This paper presents a comprehensive analysis and evaluation of eleven types of despeckling filters for echocardiographic images in terms of blind and traditional performance parameters along with clinical validation. The noise is effectively suppressed using the logarithmic neighborhood shrinkage (NeighShrink) embedded with Stein's unbiased risk estimation (SURE). The SMPI is three times more effective compared to the wavelet based generalized likelihood estimation approach. The quantitative evaluation and clinical validation reveal that the filters such as the nonlocal mean, posterior sampling based Bayesian estimation, hybrid median, and probabilistic patch based filters are acceptable whereas median, anisotropic diffusion, fuzzy, and Ripplet nonlinear approximation filters have limited applications for echocardiographic images. PMID:27298618

Underdetermined blind separation of three-way fluorescence spectra of PAHs in water

NASA Astrophysics Data System (ADS)

Yang, Ruifang; Zhao, Nanjing; Xiao, Xue; Zhu, Wei; Chen, Yunan; Yin, Gaofang; Liu, Jianguo; Liu, Wenqing

2018-06-01

In this work, underdetermined blind decomposition method is developed to recognize individual components from the three-way fluorescent spectra of their mixtures by using sparse component analysis (SCA). The mixing matrix is estimated from the mixtures using fuzzy data clustering algorithm together with the scatters corresponding to local energy maximum value in the time-frequency domain, and the spectra of object components are recovered by pseudo inverse technique. As an example, using this method three and four pure components spectra can be blindly extracted from two samples of their mixture, with similarities between resolved and reference spectra all above 0.80. This work opens a new and effective path to realize monitoring PAHs in water by three-way fluorescence spectroscopy technique.

Viewer-centered and body-centered frames of reference in direct visuomotor transformations.

PubMed

Carrozzo, M; McIntyre, J; Zago, M; Lacquaniti, F

1999-11-01

It has been hypothesized that the end-point position of reaching may be specified in an egocentric frame of reference. In most previous studies, however, reaching was toward a memorized target, rather than an actual target. Thus, the role played by sensorimotor transformation could not be disassociated from the role played by storage in short-term memory. In the present study the direct process of sensorimotor transformation was investigated in reaching toward continuously visible targets that need not be stored in memory. A virtual reality system was used to present visual targets in different three-dimensional (3D) locations in two different tasks, one with visual feedback of the hand and arm position (Seen Hand) and the other without such feedback (Unseen Hand). In the Seen Hand task, the axes of maximum variability and of maximum contraction converge toward the mid-point between the eyes. In the Unseen Hand task only the maximum contraction correlates with the sight-line and the axes of maximum variability are not viewer-centered but rotate anti-clockwise around the body and the effector arm during the move from the right to the left workspace. The bulk of findings from these and previous experiments support the hypothesis of a two-stage process, with a gradual transformation from viewer-centered to body-centered and arm-centered coordinates. Retinal, extra-retinal and arm-related signals appear to be progressively combined in superior and inferior parietal areas, giving rise to egocentric representations of the end-point position of reaching.