Transarterial chemoembolization plus or minus intravenous bevacizumab in the treatment of hepatocellular cancer: A pilot study

PubMed Central

2012-01-01

Background Stimulation of vascular endothelial growth factor (VEGF) has been observed following transarterial chemoembolization (TACE) in hepatocellular cancer (HCC) and may contribute to tumor regrowth. This pilot study examined whether intravenous (IV) bevacizumab, a monoclonal antibody against VEGF, could inhibit neovessel formation after TACE. Methods 30 subjects with HCC undergoing TACE at a single academic institution were randomized with a computer-generated allocation in a one to one ratio to either bevacizumab at a dose of 10 mg/kg IV every 14 days beginning 1 week prior to TACE (TACE-BEV arm) or observation (TACE-O arm). Angiography was performed with TACE at day 8, and again at weeks 10 and 14. Repeat TACE was performed at week 14 if indicated. TACE-BEV subjects were allowed to continue bevacizumab beyond week 16. TACE-O subjects were allowed to cross-over to bevacizumab at week 16 in the setting of progressive disease. The main outcome measure was a comparison of neovessel formation by serial angiography. Secondary outcome measures were progression free survival (PFS) at 16 weeks, overall survival (OS), bevacizumab safety, and an analysis of VEGF levels before and after TACE with and without bevacizumab. Results Among the 30 subjects enrolled, 9 of 15 randomized to the TACE-O arm and 14 of 15 randomized to the TACE-BEV arm completed all 3 angiograms. At week 14, 3 of 9 (33%) TACE-O subjects and 2 of 14 (14%) TACE-BEV subjects demonstrated neovascularity. The PFS at 16 weeks was 0.19 in the TACE-O arm and 0.79 in the TACE-BEV arm (p = 0.021). The median OS was 61 months in the TACE-O arm and 49 months in the TACE-BEV arm (p = 0.21). No life-threatening bevacizumab-related toxicities were observed. There were no substantial differences in bevacizumab pharmacokinetics compared to historical controls. Bevacizumab attenuated the increase in VEGF observed post-TACE. Conclusions IV bevacizumab was well tolerated in selected HCC subjects undergoing TACE, and appeared to diminish neovessel formation at week 14. Trial registration ClinicalTrials.gov NCT00049322. PMID:22244160

Effectiveness and cost-effectiveness of admissions to women's crisis houses compared with traditional psychiatric wards: pilot patient-preference randomised controlled trial.

PubMed

Howard, L; Flach, C; Leese, M; Byford, S; Killaspy, H; Cole, L; Lawlor, C; Betts, J; Sharac, J; Cutting, P; McNicholas, S; Johnson, S

2010-08-01

Women's crisis houses have been developed in the UK as a less stigmatising and less institutional alternative to traditional psychiatric wards. To examine the effectiveness and cost-effectiveness of women's crisis houses by first examining the feasibility of a pilot patient-preference randomised controlled trial (PP-RCT) design (ISRCTN20804014). We used a PP-RCT study design to investigate women presenting in crisis needing informal admission. The four study arms were the patient preference arms of women's crisis house or hospital admission, and randomised arms of women's crisis house or hospital admission. Forty-one women entered the randomised arms of the trial (crisis house n = 19, wards n = 22) and 61 entered the patient-preference arms (crisis house n = 37, ward n = 24). There was no significant difference in outcomes (symptoms, functioning, perceived coercion, stigma, unmet needs or quality of life) or costs for any of the groups (randomised or preference arms), but women who obtained their preferred intervention were more satisfied with treatment. Although the sample sizes were too small to allow definite conclusions, the results suggest that when services are able to provide interventions preferred by patients, those patients are more likely to be satisfied with treatment. This pilot study provides some evidence that women's crisis houses are as effective as traditional psychiatric wards, and may be more cost-effective.

Main outcomes of an RCT to pilot test reporting and feedback to foster research integrity climates in the VA.

PubMed

Martinson, Brian C; Mohr, David C; Charns, Martin P; Nelson, David; Hagel-Campbell, Emily; Bangerter, Ann; Bloomfield, Hanna E; Owen, Richard; Thrush, Carol R

2017-01-01

Assessing the integrity of research climates and sharing such information with research leaders may support research best practices. We report here results of a pilot trial testing the effectiveness of a reporting and feedback intervention using the Survey of Organizational Research Climate (SOuRCe). We randomized 41 Veterans Health Administration (VA) facilities to a phone-based intervention designed to help research leaders understand their survey results (enhanced arm) or to an intervention in which results were simply distributed to research leaders (basic arm). Primary outcomes were (1) whether leaders took action, (2) whether actions taken were consistent with the feedback received, and (3) whether responses differed by receptivity to quality improvement input. Research leaders from 25 of 42 (59%) VA facilities consented to participate in the study intervention and follow-up, of which 14 were at facilities randomized to the enhanced arm. We completed follow-up interviews with 21 of the 25 leaders (88%), 12 from enhanced arm facilities. While not statistically significant, the proportion of leaders reporting taking some action in response to the feedback was twice as high in the enhanced arm than in the basic arm (67% vs. 33%, p = .20). While also not statistically significant, a higher proportion of actions taken among facilities in the enhanced arm were responsive to the survey results than in the basic arm (42% vs. 22%, p = .64). Enhanced feedback of survey results appears to be a promising intervention that may increase the likelihood of responsive action to improve organizational climates. Due to the small sample size of this pilot study, even large percentage-point differences between study arms are not statistically distinguishable. This hypothesis should be tested in a larger trial.

Successful Completion of the Pilot Phase of a Randomized Controlled Trial Comparing Sentinel Lymph Node Biopsy to No Further Axillary Staging in Patients with Clinical T1-T2 N0 Breast Cancer and Normal Axillary Ultrasound

PubMed Central

Cyr, Amy E; Tucker, Natalia; Ademuyiwa, Foluso; Margenthaler, Julie A; Aft, Rebecca L; Eberlein, Timothy J; Appleton, Catherine M; Zoberi, Imran; Thomas, Maria A; Gao, Feng; Gillanders, William E

2016-01-01

Background Axillary surgery is not considered therapeutic in patients with clinical T1-T2 N0 breast cancer. The importance of axillary staging is eroding in an era where tumor biology, as defined by biomarker and gene expression profile, is increasingly important in medical decision making. We hypothesize that axillary ultrasound (AUS) is a noninvasive alternative to sentinel lymph node biopsy (SLNB), and AUS could replace SLNB without compromising patient care. Study Design Patients with clinical T1-T2 N0 breast cancer and normal AUS were eligible for enrollment. Subjects were randomized to no further axillary staging (Arm 1) versus SLNB (Arm 2). Descriptive statistics were used to describe the results of the pilot phase of the randomized controlled trial. Results 68 subjects were enrolled in the pilot phase of the trial (34 subjects in Arm 1, no further staging; 32 subjects in Arm 2, SLNB, and 2 subjects voluntarily withdrew from the trial). The median age was 61 years (range 40-80) in Arm 1 and 59 years (range 31-81) in Arm 2, and there were no significant clinical or pathologic differences between the arms. Median follow-up was 17 months (range 1-32). The negative predictive value (NPV) of AUS for identification of clinically significant axillary disease (> 2.0 mm) was 96.9%. No axillary recurrences have been observed in either arm. Conclusions Successful completion of the pilot phase of the randomized controlled trial confirms the feasibility of the study design, and provides prospective evidence supporting the ability of AUS to exclude clinically significant disease in the axilla. The results provide strong support for a phase 2 randomized controlled trial. PMID:27212005

Gaming and Conventional Exercises for Improvement of Arm Function After Stroke: A Randomized Controlled Pilot Study.

PubMed

Kottink, Anke I R; Prange, Gerdienke B; Krabben, Thijs; Rietman, Johan S; Buurke, Jaap H

2014-06-01

The use of new technologies in rehabilitation, such as virtual reality and/or computerized gaming exercises, may be useful to enable patients to practice intensively in a motivating way. The objective of the present randomized controlled pilot study was to compare the effect of reach training using a target group specific-designed rehabilitation game to time-matched standardized conventional reach training on arm function after stroke. Twenty chronic stroke patients were randomized to either the rehabilitation game group or the conventional training group. Both groups received three arm training sessions of 30 minutes each week, during a period of 6 weeks. Arm (the upper extremity part of Fugl-Meyer [FM] assessment) and hand (the Action Research Arm [ARA] test) functions were tested 1 week before (T0) and 1 week after (T1) training. A follow-up measurement was performed at 1 month after T1 (T2). ARA and FM scores improved significantly within both groups. Post hoc comparisons revealed significant increases in test scores between T0 and T1 and between T0 and T2 for both ARA and FM, but not for changes from T1 to T2. There were no significant differences between both groups for either clinical test. The present randomized controlled pilot study showed that both arm and hand function improved as much after training with a rehabilitation game as after time-matched conventional training.

A dietary intervention to elicit rapid and complex dietary changes for studies investigating the effects of diet on tissues collected during invasive surgical procedures.

PubMed

Schenk, Jeannette M; Neuhouser, Marian L; Lin, Daniel W; Kristal, Alan R

2009-03-01

Nutrition intervention trials in patients undergoing surgical treatment for cancer offer a unique opportunity to study the mechanisms and pathways that underlie diet and cancer associations in target tissues. However, due to the short time period between diagnosis and treatment, traditional dietary intervention methods are not feasible. This report describes a novel dietary intervention program designed to elicit rapid and complex dietary change during a condensed study period. The intervention, based on Consumer Information Processing, used standardized menus and exchange lists to guide food choices, and was delivered using a single, in-person session followed by telephone-based counseling. This intervention program was used in a small pilot study evaluating the short-term effects of dietary change in men with newly diagnosed prostate cancer. Eight men were randomly assigned to either a low-fat/low-glycemic load or standard American diet during the 4 weeks preceding prostate surgery. Participants completed 24-hour dietary recalls each week, and were weighed at baseline and at surgery. Compared to men in the standard American arm (n=4), men in the low-fat/low-glycemic arm (n=4) reported consuming less total fat (51.0+/-36.0 vs 93.5+/-8.4 g/day, P=0.06), and had a lower glycemic load (134.8+/-6.0 vs 266.3+/-36.8 units/day, P<0.001). Men in the low-fat/low-glycemic arm lost a mean of 5.3+/-1.7 kg and men in the standard American arm gained 0.8+/-4.5 kg (P=0.04). Results of this small pilot study suggest that a relatively simple and minimally burdensome dietary intervention can elicit rapid and complex dietary changes that are maintained over a 4-week study period. Further studies in larger and more diverse populations are needed to fully understand the potential of this novel intervention approach.

Recommendations for the Implementation of the LASSO Workflow

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

Gustafson, William I; Vogelmann, Andrew M; Cheng, Xiaoping

The U. S. Department of Energy (DOE) Atmospheric Radiation Measurement (ARM) Research Fa-cility began a pilot project in May 2015 to design a routine, high-resolution modeling capability to complement ARM’s extensive suite of measurements. This modeling capability, envisioned in the ARM Decadal Vision (U.S. Department of Energy 2014), subsequently has been named the Large-Eddy Simu-lation (LES) ARM Symbiotic Simulation and Observation (LASSO) project, and it has an initial focus of shallow convection at the ARM Southern Great Plains (SGP) atmospheric observatory. This report documents the recommendations resulting from the pilot project to be considered by ARM for imple-mentation into routinemore » operations. During the pilot phase, LASSO has evolved from the initial vision outlined in the pilot project white paper (Gustafson and Vogelmann 2015) to what is recommended in this report. Further details on the overall LASSO project are available at https://www.arm.gov/capabilities/modeling/lasso. Feedback regarding LASSO and the recommendations in this report can be directed to William Gustafson, the project principal investigator (PI), and Andrew Vogelmann, the co-principal investigator (Co-PI), via lasso@arm.gov.« less

Targeting Aging with Functional Food: Pasta with Opuntia Single-Arm Pilot Study.

PubMed

Aiello, Anna; Di Bona, Danilo; Candore, Giuseppina; Carru, Ciriaco; Zinellu, Angelo; Di Miceli, Giuseppe; Nicosia, Aldo; Gambino, Caterina Maria; Ruisi, Paolo; Caruso, Calogero; Vasto, Sonya; Accardi, Giulia

2018-06-01

Interventions to extend life span represent the new perspective in aging investigation. Healthy dietary habits are important modifiable factors that can favor a healthy aging phenotype. Many studies have demonstrated benefits for metabolic syndrome and type 2 diabetes mellitus resulting from the traditional Mediterranean foods. Opuntia Ficus Indica (OFI), widespread in the Mediterranean basin, belongs to the Cactaceae family. It is known for its antioxidant and anti-inflammatory properties. Moreover, products containing extracts from OFI fruits or cladodes have been used to control obesity and other metabolic parameters, such as glycemia and lipid profile. The aim of this study was to analyze the antioxidant and anti-inflammatory effect of pasta with 3% of OFI cladode extracts added to show its beneficial effect in human health. We performed a single arm longitudinal intervention study in 42 healthy volunteers, administrating 500 g/week of this functional pasta for 30 days. Our pasta had antioxidant and anti-inflammatory properties with putative effect on the aging process and related metabolic diseases. We also demonstrated a hypoglycemic effect. The results are preliminary, but it is possible to speculate that our pasta could be considered an effective food for the prevention of age-related metabolic disorders.

Pilot study of a robotic protocol to treat shoulder subluxation in patients with chronic stroke

PubMed Central

2013-01-01

Background Shoulder subluxation is a frequent complication of motor impairment after stroke, leading to soft tissue damage, stretching of the joint capsule, rotator cuff injury, and in some cases pain, thus limiting use of the affected extremity beyond weakness. In this pilot study, we determined whether robotic treatment of chronic shoulder subluxation can lead to functional improvement and whether any improvement was robust. Methods 18 patients with chronic stroke (3.9 ± 2.9 years from acute stroke), completed 6 weeks of robotic training using the linear shoulder robot. Training was performed 3 times per week on alternate days. Each session consisted of 3 sets of 320 repetitions of the affected arm, and the robotic protocol alternated between training vertical arm movements, shoulder flexion and extension, in an anti-gravity plane, and training horizontal arm movements, scapular protraction and retraction, in a gravity eliminated plane. Results Training with the linear robot improved shoulder stability, motor power, and resulted in improved functional outcomes that were robust 3 months after training. Conclusion In this uncontrolled pilot study, the robotic protocol effectively treated shoulder subluxation in chronic stroke patients. Treatment of subluxation can lead to improved functional use of the affected arm, likely by increasing motor power in the trained muscles. PMID:23914834

Pilot study of a robotic protocol to treat shoulder subluxation in patients with chronic stroke.

PubMed

Dohle, Carolin I; Rykman, Avrielle; Chang, Johanna; Volpe, Bruce T

2013-08-05

Shoulder subluxation is a frequent complication of motor impairment after stroke, leading to soft tissue damage, stretching of the joint capsule, rotator cuff injury, and in some cases pain, thus limiting use of the affected extremity beyond weakness. In this pilot study, we determined whether robotic treatment of chronic shoulder subluxation can lead to functional improvement and whether any improvement was robust. 18 patients with chronic stroke (3.9 ± 2.9 years from acute stroke), completed 6 weeks of robotic training using the linear shoulder robot. Training was performed 3 times per week on alternate days. Each session consisted of 3 sets of 320 repetitions of the affected arm, and the robotic protocol alternated between training vertical arm movements, shoulder flexion and extension, in an anti-gravity plane, and training horizontal arm movements, scapular protraction and retraction, in a gravity eliminated plane. Training with the linear robot improved shoulder stability, motor power, and resulted in improved functional outcomes that were robust 3 months after training. In this uncontrolled pilot study, the robotic protocol effectively treated shoulder subluxation in chronic stroke patients. Treatment of subluxation can lead to improved functional use of the affected arm, likely by increasing motor power in the trained muscles.

Smartphone-Enabled Health Coach Intervention for People With Diabetes From a Modest Socioeconomic Strata Community: Single-Arm Longitudinal Feasibility Study

PubMed Central

2014-01-01

Background Lower socioeconomic strata (SES) populations have higher chronic disease risks. Smartphone-based interventions can support adoption of health behaviors that may, in turn, reduce the risks of type 2 diabetes-related complications, overcoming the obstacles that some patients may have with regular clinical contact (eg, shiftwork, travel difficulties, miscommunication). Objective The intent of the study was to develop and test a smartphone-assisted intervention that improves behavioral management of type 2 diabetes in an ethnically diverse, lower SES population within an urban community health setting. Methods This single-arm pilot study assessed a smartphone application developed with investigator assistance and delivered by health coaches. Participants were recruited from the Black Creek Community Health Centre in Toronto and had minimal prior experience with smartphones. Results A total of 21 subjects consented and 19 participants completed the 6-month trial; 12 had baseline glycosylated hemoglobin (HbA1c) levels >7.0% and these subjects demonstrated a mean reduction of 0.43% (SD 0.63) (P<.05) with minimal changes in medication. Conclusions This project supported the feasibility of smartphone-based health coaching for individuals from lower SES with minimal prior smartphone experience. PMID:24907918

Feasibility of the Atlas Unicompartmental Knee System Load Absorber in Improving Pain Relief and Function in Patients Needing Unloading of the Medial Compartment of the Knee: 1-Year Follow-Up of a Prospective, Multicenter, Single-Arm Pilot Study (PHANTOM High Flex Trial).

PubMed

Slynarski, Konrad; Walawski, Jacek; Smigielski, Robert; van der Merwe, Willem

2017-01-01

In young patients with medial knee osteoarthritis (OA), surgical intervention may not be desirable due to preferences to avoid bone cutting procedures, return to high activity levels, and prolong implant survival. The Atlas Knee System was designed to fill the gap between ineffective conservative treatments and invasive surgery. This single-arm study included 26 patients, aged 25 to 65 years, who completed 12 months of follow-up. All dimensions of the Knee injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Knee Society Score significantly improved from baseline to 12 months. About 96.2% and 92.3% of patients experienced a ⩾20% improvement in their KOOS pain and WOMAC pain scores, respectively, at 12 months. This study highlights the potential benefit of a joint unloading device in the management of young patients with medial knee OA. The trial is still ongoing and another analysis is planned at 24 months.

Smartphone-enabled health coach intervention for people with diabetes from a modest socioeconomic strata community: single-arm longitudinal feasibility study.

PubMed

Wayne, Noah; Ritvo, Paul

2014-06-06

Lower socioeconomic strata (SES) populations have higher chronic disease risks. Smartphone-based interventions can support adoption of health behaviors that may, in turn, reduce the risks of type 2 diabetes-related complications, overcoming the obstacles that some patients may have with regular clinical contact (eg, shiftwork, travel difficulties, miscommunication). The intent of the study was to develop and test a smartphone-assisted intervention that improves behavioral management of type 2 diabetes in an ethnically diverse, lower SES population within an urban community health setting. This single-arm pilot study assessed a smartphone application developed with investigator assistance and delivered by health coaches. Participants were recruited from the Black Creek Community Health Centre in Toronto and had minimal prior experience with smartphones. A total of 21 subjects consented and 19 participants completed the 6-month trial; 12 had baseline glycosylated hemoglobin (HbA1c) levels >7.0% and these subjects demonstrated a mean reduction of 0.43% (SD 0.63) (P<.05) with minimal changes in medication. This project supported the feasibility of smartphone-based health coaching for individuals from lower SES with minimal prior smartphone experience.

Successful Completion of the Pilot Phase of a Randomized Controlled Trial Comparing Sentinel Lymph Node Biopsy to No Further Axillary Staging in Patients with Clinical T1-T2 N0 Breast Cancer and Normal Axillary Ultrasound.

PubMed

Cyr, Amy E; Tucker, Natalia; Ademuyiwa, Foluso; Margenthaler, Julie A; Aft, Rebecca L; Eberlein, Timothy J; Appleton, Catherine M; Zoberi, Imran; Thomas, Maria A; Gao, Feng; Gillanders, William E

2016-08-01

Axillary surgery is not considered therapeutic in patients with clinical T1-T2 N0 breast cancer. The importance of axillary staging is eroding in an era in which tumor biology, as defined by biomarker and gene expression profile, is increasingly important in medical decision making. We hypothesized that axillary ultrasound (AUS) is a noninvasive alternative to sentinel lymph node biopsy (SLNB), and AUS could replace SLNB without compromising patient care. Patients with clinical T1-T2 N0 breast cancer and normal AUS were eligible for enrollment. Subjects were randomized to no further axillary staging (arm 1) vs SLNB (arm 2). Descriptive statistics were used to describe the results of the pilot phase of the randomized controlled trial. Sixty-eight subjects were enrolled in the pilot phase of the trial (34 subjects in arm 1, no further staging; 32 subjects in arm 2, SLNB; and 2 subjects voluntarily withdrew from the trial). The median age was 61 years (range 40 to 80 years) in arm 1 and 59 years (range 31 to 81 years) in arm 2, and there were no significant clinical or pathologic differences between the arms. Median follow-up was 17 months (range 1 to 32 months). The negative predictive value (NPV) of AUS for identification of clinically significant axillary disease (>2.0 mm) was 96.9%. No axillary recurrences have been observed in either arm. Successful completion of the pilot phase of the randomized controlled trial confirms the feasibility of the study design, and provides prospective evidence supporting the ability of AUS to exclude clinically significant disease in the axilla. The results provide strong support for a phase 2 randomized controlled trial. Copyright © 2016 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

A randomized trial of enema versus polyethylene glycol 3350 for fecal disimpaction in children presenting to an emergency department.

PubMed

Miller, Melissa K; Dowd, Mary Denise; Friesen, Craig A; Walsh-Kelly, Christine M

2012-02-01

This study aimed to compare efficacy of enema versus polyethylene glycol (PEG) 3350 for pediatric fecal impaction treatment. We conducted a prospective, randomized comparison of treatments of fecal impaction in children in a pediatric emergency department (ED). Treatment arms were a single milk and molasses enema in the ED or PEG 3350 for 3 days outpatient. Telephone follow-up was done on days 1, 3, and 5. The primary outcome was main symptom improvement. Additional outcomes were stool frequency, consistency, and ease of stool passage. Treatment failures (home enema, ED return, or hospital admission) were tracked. Seventy-nine subjects participated (39 PEG; 40 enema). At day 1, PEG subjects were less likely to have improved main symptom (odds ratio [OR], 0.3; 95% confidence interval [CI], 0.1-0.8) but no difference in other outcomes. Half (54%) in enema arm were reported as upset by ED therapy, whereas no children in PEG arm were upset (P < 0.05). At day 3, more patients in enema arm reported ideal stool consistency (74% vs 38%; P < 0.05). At day 5, no difference between groups was noted. Most treatment failures were in PEG arm (83%; P = 0.08). This pilot study suggests that disimpaction by enema may be superior to PEG for immediate relief of symptoms. Larger trials are needed to assess any advantage.

Anthropometric considerations for a 4-axis side-arm flight controller

NASA Technical Reports Server (NTRS)

Debellis, W. B.

1986-01-01

A data base on multiaxis side-arm flight controls was generated. The rapid advances in fly-by-light technology, automatic stability systems, and onboard computers have combined to create flexible flight control systems which could reduce the workload imposed on the operator by complex new equipment. This side-arm flight controller combines four controls into one unit and should simplify the pilot's task. However, the use of a multiaxis side-arm flight controller without complete cockpit integration may tend to increase the pilot's workload.

Successful pharmacogenetics-based optimization of unboosted atazanavir plasma exposure in HIV-positive patients: a randomized, controlled, pilot study (the REYAGEN study).

PubMed

Bonora, S; Rusconi, S; Calcagno, A; Bracchi, M; Viganò, O; Cusato, J; Lanzafame, M; Trentalange, A; Marinaro, L; Siccardi, M; D'Avolio, A; Galli, M; Di Perri, G

2015-11-01

Atazanavir without ritonavir, despite efficacy and tolerability, shows low plasma concentrations that warrant optimization. In a randomized, controlled, pilot trial, stable HIV-positive patients on atazanavir/ritonavir (with tenofovir/emtricitabine) were switched to atazanavir. In the standard-dose arm, atazanavir was administered as 400 mg once daily, while according to patients' genetics (PXR, ABCB1 and SLCO1B1), in the pharmacogenetic arm: patients with unfavourable genotypes received 200 mg of atazanavir twice daily. EudraCT number: 2009-014216-35. Eighty patients were enrolled with balanced baseline characteristics. The average atazanavir exposure was 253 ng/mL (150-542) in the pharmacogenetic arm versus 111 ng/mL (64-190) in the standard-dose arm (P < 0.001); 28 patients in the pharmacogenetic arm (75.7%) had atazanavir exposure >150 ng/mL versus 14 patients (38.9%) in the standard-dose arm (P = 0.001). Immunovirological and laboratory parameters had a favourable outcome throughout the study with non-significant differences between study arms. Atazanavir plasma exposure is higher when the schedule is chosen according to the patient's genetic profile. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

A maintenance three-day-per-week schedule with the single tablet regimen efavirenz/emtricitabine/tenofovir disoproxil fumarate is effective and decreases sub-clinical toxicity: the A-TRI-WEEK pilot trial.

PubMed

Rojas, Jhon; Blanco, Jose L; Sanchez-Palomino, Sonsoles; Marcos, Maria A; Guardo, Alberto C; Gonzalez-Cordon, Ana; Lonca, Montserrat; Tricas, Amparo; Rodriguez, Ana; Romero, Anabel; Miro, Jose M; Mallolas, Josep; Gatell, Jose M; Plana, Montserrat; Martinez, Esteban

2018-05-09

Antiretroviral drugs contained in single tablet Atripla® have pharmacokinetic properties that could allow for longer than once-daily (OD) dosing. We hypothesized that simplifying Atripla® OD to 3-day per week would be feasible, able to maintain viral suppression and less toxic. Virologically suppressed (≥2 years) HIV+ adults on Atripla® OD, CD4 >350/mm at inclusion, and no prior documented virological failure or evidence of resistance mutations to efavirenz, tenofovir, or emtricitabine were randomized to maintain their OD regimen or to reduce it to 3 days (Mondays, Wednesdays, and Fridays) a week (3W). Primary end-point was the proportion of patients free of treatment failure (non-completer = failure) at 24 weeks. CD4 and CD8 cells, ultrasensitive HIV-1 RNA, Pittsburg Sleep Quality Index (PSQI), bone mineral density, plasma efavirenz levels, and fasting blood and urine chemistries were measured at baseline and 24 weeks. The study is registered at ClinicalTrials.gov, NCT01778413. Sixty-one patients were randomized. All patients in both arms remained free of treatment failure (estimated difference 0%; 95% confidence interval -14.1 to 14.1). Ultrasensitive plasma HIV-1 RNA below detection threshold showed no difference between arms (70% in the 3W arm vs. 71% in the OD arm, P = 0.933) at 24 weeks. Total cholesterol and femur T-score significantly increased, while PSQI, plasma efavirenz, albumin/creatinine and beta-2-microglobulin in urine significantly decreased in the 3W arm relative to OD arm. The A-TRI-WEEK study represents a proof of concept for the feasibility of three-day per week Atripla® maintenance that should be further confirmed in a larger, well-powered clinical trial.

Robot-Assisted Training of Arm and Hand Movement Shows Functional Improvements for Incomplete Cervical Spinal Cord Injury.

PubMed

Francisco, Gerard E; Yozbatiran, Nuray; Berliner, Jeffrey; OʼMalley, Marcia K; Pehlivan, Ali Utku; Kadivar, Zahra; Fitle, Kyle; Boake, Corwin

2017-10-01

The aim of the study was to demonstrate the feasibility, tolerability, and effectiveness of robotic-assisted arm training in incomplete chronic tetraplegia. Pretest/posttest/follow-up was conducted. Ten individuals with chronic cervical spinal cord injury were enrolled. Participants performed single degree-of-freedom exercise of upper limbs at an intensity of 3-hr per session for 3 times a week for 4 wks with MAHI Exo-II. Arm and hand function tests (Jebsen-Taylor Hand Function Test, Action Research Arm Test), strength of upper limb (upper limb motor score, grip, and pinch strength), and independence in daily living activities (Spinal Cord Independence Measure II) were performed at baseline, end of training, and 6 mos later. After 12 sessions of training, improvements in arm and hand functions were observed. Jebsen-Taylor Hand Function Test (0.14[0.04]-0.21[0.07] items/sec, P = 0.04), Action Research Arm Test (30.7[3.8]-34.3[4], P = 0.02), American Spinal Injury Association upper limb motor score (31.5[2.3]-34[2.3], P = 0.04) grip (9.7[3.8]-12[4.3] lb, P = 0.02), and pinch strength (4.5[1.1]-5.7[1.2] lb, P = 0.01) resulted in significant increases. Some gains were maintained at 6 mos. No change in Spinal Cord Independence Measure II scores and no adverse events were observed. Results from this pilot study suggest that repetitive training of arm movements with MAHI Exo-II exoskeleton is safe and has potential to be an adjunct treatment modality in rehabilitation of persons with spinal cord injury with mild to moderate impaired arm functions.

Automated Detection of Actinic Keratoses in Clinical Photographs

PubMed Central

Hames, Samuel C.; Sinnya, Sudipta; Tan, Jean-Marie; Morze, Conrad; Sahebian, Azadeh; Soyer, H. Peter; Prow, Tarl W.

2015-01-01

Background Clinical diagnosis of actinic keratosis is known to have intra- and inter-observer variability, and there is currently no non-invasive and objective measure to diagnose these lesions. Objective The aim of this pilot study was to determine if automatically detecting and circumscribing actinic keratoses in clinical photographs is feasible. Methods Photographs of the face and dorsal forearms were acquired in 20 volunteers from two groups: the first with at least on actinic keratosis present on the face and each arm, the second with no actinic keratoses. The photographs were automatically analysed using colour space transforms and morphological features to detect erythema. The automated output was compared with a senior consultant dermatologist’s assessment of the photographs, including the intra-observer variability. Performance was assessed by the correlation between total lesions detected by automated method and dermatologist, and whether the individual lesions detected were in the same location as the dermatologist identified lesions. Additionally, the ability to limit false positives was assessed by automatic assessment of the photographs from the no actinic keratosis group in comparison to the high actinic keratosis group. Results The correlation between the automatic and dermatologist counts was 0.62 on the face and 0.51 on the arms, compared to the dermatologist’s intra-observer variation of 0.83 and 0.93 for the same. Sensitivity of automatic detection was 39.5% on the face, 53.1% on the arms. Positive predictive values were 13.9% on the face and 39.8% on the arms. Significantly more lesions (p<0.0001) were detected in the high actinic keratosis group compared to the no actinic keratosis group. Conclusions The proposed method was inferior to assessment by the dermatologist in terms of sensitivity and positive predictive value. However, this pilot study used only a single simple feature and was still able to achieve sensitivity of detection of 53.1% on the arms.This suggests that image analysis is a feasible avenue of investigation for overcoming variability in clinical assessment. Future studies should focus on more sophisticated features to improve sensitivity for actinic keratoses without erythema and limit false positives associated with the anatomical structures on the face. PMID:25615930

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.

A prospective pilot study to evaluate an animated home-based physical exercise program as a treatment option for patients with rheumatoid arthritis.

PubMed

Zernicke, Jan; Kedor, Claudia; Müller, Angela; Burmester, Gerd-Rüdiger; Reißhauer, Anett; Feist, Eugen

2016-08-18

Physical exercises and physiotherapy are of great importance for maintenance of joint function in patients with rheumatoid arthritis (RA). However, many RA patients complain about problems to receive prescriptions or have a lack of access to physiotherapy. Recent reports have shown positive effects of the Wii game console on physical and psychosocial conditions of patients with other underlying diseases. The primary objectives of this prospective controlled pilot study were to investigate feasibility and patients' assessment using an animated home-based exercise program. This pilot study was conducted as a single-center, cross-over trial with two treatment arms over 24 weeks. Eligibility criteria included patients with RA reaching low disease activity under therapy with a biological disease modifying anti-rheumatic drug (bDMARD). After detailed instruction, 15 patients started with a conventional home-based physical exercise program and 15 patients began with a predefined animated exercise program by using the Wii game console for 12 weeks. Afterwards, patients were crossed-over to the other treatment arm for another period of 12 weeks. Multi-methodical assessments were performed by qualitative analysis of the interview-data as well as statistical analysis of functional tests and patient reported outcomes (PRO's). Evaluation of the interviews indicated feasibility and usefulness of the chosen animated home-based exercise program. Forefoot disabilities were identified as a main limiting factor for performing some of the animated exercises. After 12 weeks, both treatment arms showed improvement of functional tests without significant differences between groups: Overall muscle strength improved for a mean value of 10 Newton (+12 %) and the mean 6-min walk test (6-MWT) distance increased for 28 meters (+5 %). This study showed that an animated home-based exercise program by using a Wii game console was feasible and beneficial for RA patients. Compared to standard physical home exercises, similar effects were observed indicating that such an animated program might be an alternative supportive option for RA patients. ClinicalTrials.gov ID: NCT02658370 (19-Jan-2016).

Effects of low-intensity bench press training with restricted arm muscle blood flow on chest muscle hypertrophy: a pilot study.

PubMed

Yasuda, Tomohiro; Fujita, Satoshi; Ogasawara, Riki; Sato, Yoshiaki; Abe, Takashi

2010-09-01

Single-joint resistance training with blood flow restriction (BFR) results in significant increases in arm or leg muscle size and single-joint strength. However, the effect of multijoint BFR training on both blood flow restricted limb and non-restricted trunk muscles remain poorly understood. To examine the impact of BFR bench press training on hypertrophic response to non-restricted (chest) and restricted (upper-arm) muscles and multi-joint strength, 10 young men were randomly divided into either BFR training (BFR-T) or non-BFR training (CON-T) groups. They performed 30% of one repetition maximal (1-RM) bench press exercise (four sets, total 75 reps) twice daily, 6 days week(-1) for 2 weeks. During the exercise session, subjects in the BFR-T group placed elastic cuffs proximally on both arms, with incremental increases in external compression starting at 100 mmHg and ending at 160 mmHg. Before and after the training, triceps brachii and pectoralis major muscle thickness (MTH), bench press 1-RM and serum anabolic hormones were measured. Two weeks of training led to a significant increase (P<0.05) in 1-RM bench press strength in BFR-T (6%) but not in CON-T (-2%). Triceps and pectoralis major MTH increased 8% and 16% (P<0.01), respectively, in BFR-T, but not in CON-T (-1% and 2%, respectively). There were no changes in baseline concentrations of anabolic hormones in either group. These results suggest that BFR bench press training leads to significant increases in muscle size for upper arm and chest muscles and 1-RM strength.

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

PubMed Central

Dobkin, Bruce H.

2014-01-01

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

Exploring the costs and outcomes of sexually transmitted infection (STI) screening interventions targeting men in football club settings: preliminary cost-consequence analysis of the SPORTSMART pilot randomised controlled trial

PubMed Central

Jackson, Louise J; Roberts, Tracy E; Fuller, Sebastian S; Sutcliffe, Lorna J; Saunders, John M; Copas, Andrew J; Mercer, Catherine H; Cassell, Jackie A; Estcourt, Claudia S

2015-01-01

Background The objective of this study was to compare the costs and outcomes of two sexually transmitted infection (STI) screening interventions targeted at men in football club settings in England, including screening promoted by team captains. Methods A comparison of costs and outcomes was undertaken alongside a pilot cluster randomised control trial involving three trial arms: (1) captain-led and poster STI screening promotion; (2) sexual health advisor-led and poster STI screening promotion and (3) poster-only STI screening promotion (control/comparator). For all study arms, resource use and cost data were collected prospectively. Results There was considerable variation in uptake rates between clubs, but results were broadly comparable across study arms with 50% of men accepting the screening offer in the captain-led arm, 67% in the sexual health advisor-led arm and 61% in the poster-only control arm. The overall costs associated with the intervention arms were similar. The average cost per player tested was comparable, with the average cost per player tested for the captain-led promotion estimated to be £88.99 compared with £88.33 for the sexual health advisor-led promotion and £81.87 for the poster-only (control) arm. Conclusions Costs and outcomes were similar across intervention arms. The target sample size was not achieved, and we found a greater than anticipated variability between clubs in the acceptability of screening, which limited our ability to estimate acceptability for intervention arms. Further evidence is needed about the public health benefits associated with screening interventions in non-clinical settings so that their cost-effectiveness can be fully evaluated. PMID:25512670

[Sulphurous vaginal douching and vulvovaginal atrophy].

PubMed

Costantino, M; Conti, V; Marongiu, M B; Napolano, G; Filippelli, A

2017-01-01

During climacteric the reduction or interruption of estrogenic stimulus determines a gradual atrophy of the tissues of the urogenital tract.Vulvovaginal atrophy can be cause of dryness, itch, burning, and dyspareunia. Vulvovaginal atrophy is associated also with depression. Hence the importance of an appropriate treatment of the vulvovaginal atrophy. Between therapeutic options we can add, particularly for women who suffer only from vaginal symptoms, the spa therapy that uses mineral waters with benefic effects on vaginal tissue wellness and health. On the basis of considerations described above and on the insufficient literature data, the objective of our single-arm pilot study has been to evaluate, in women suffering from vulvovaginal atrophy, the effects and safety of a vaginal douching cycle with sulphurous mineral water and impact on depression disorder frequently observed. The study was conducted on 24 women affected by vulvovaginal atrophy; mean age:57±11 years; age range:42-81 years. The subjects were treated, for 2 weeks, with sulphurous vaginal douching from Terme of Telese S.p.A. (Benevento-Italy). At the beginning and at the end of the SPA treatment the following symptoms were evaluated: dryness, burning, itch, dyspareunia and leucorrhoea (using VAS scale); the impact on psychological distress (using S.D.S. Zung-test). At the end of the spa treatment, the mean values±SD, compared to baseline, have showed a significant (p<0.05) reduction in leucorrhoea (-88%), in vulvar itch (-79%), in vaginal burning (-71%), in vaginal dryness (-65%) with an improvement of psichological distress as demonstrated by S.D.S. Zung-test. The data of this single-arm pilot clinical trial show that the sulphurous vaginal douching cycle can be considered very useful in women suffering from vulvovaginal atrophy with improving of the quality of life and social relationship.

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

PubMed

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

2017-06-01

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

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

PubMed Central

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

2017-01-01

Introduction The purpose of this pilot study was to establish the feasibility of completing a future controlled trial of a multi-component cognitive behavioral therapy for insomnia program for military veterans with sleep disturbance. Method This was a single-arm feasibility and pilot study. Participants were United States post-9/11 veterans with service-connected injuries, university students, and had self-reported sleep disturbances. Restoring Effective Sleep Tranquility was a multi-component cognitive behavioral therapy for insomnia intervention consisting of seven sessions of group therapy and eight 1:1 sessions delivered by occupational therapists. Feasibility and pilot indicators were process, resources, management, and scientific, including pre–post-assessments of sleep difficulties, dysfunctional sleep beliefs, participation, and pain interference. Findings Indicators were supportive of feasibility, including reduced sleep difficulties (for example Medical Outcomes Study Sleep Measure [t = 3.29, p = .02]), reduced nightmares: t = 2.79, p = .03; fewer dysfunctional sleep beliefs: t = 3.63, p = .01, and greater ability to participate in social roles: t = –2.86, p = .03, along with trends towards improved satisfaction with participation and reduced pain interference. Conclusion The Restoring Effective Sleep Tranquility program may reduce sleep difficulties and improve participation in US veterans with service-connected injuries, and evidence indicates a controlled trial would be feasible to deliver. PMID:28626295

Pilot study of once-daily simplification therapy with abacavir/lamivudine/zidovudine and efavirenz for treatment of HIV-1 infection.

PubMed

Ruane, Peter; Lang, Joseph; DeJesus, Edwin; Berger, Daniel S; Dretler, Robin; Rodriguez, Allan; Ward, Douglas J; Lim, Michael L; Liao, Qiming; Reddy, Sunila; Clair, Marty St; Vila, Tania; Shaefer, Mark S

2006-01-01

The purpose of this pilot study was to explore the efficacy and safety of the abacavir/lamivudine/zidovudine fixed-dose combination tablet administered as two tablets once daily (qd) versus one tablet twice daily (bid) in combination with efavirenz (EFV). This was a prospective, randomized, open-label, multicenter study with a 24-week treatment period in 7 outpatient HIV clinics in the United States. Patients currently receiving an initial regimen of abacavir/lamivudine/zidovudine bid plus EFV qd for at least 6 months with HIV-1 RNA <50 copies/mL for at least 3 months and a screening CD4+ cell count > or = 200 cells/mm3 were eligible. Thirty-six patients enrolled, and 35 (97%) completed the study. Participants were randomized to switch to 2 tablets of abacavir/lamivudine/zidovudine qd plus EFV qd (QD arm) or continue current treatment (BID arm) for 24 weeks. Efficacy, safety, and adherence were evaluated. Median baseline CD4+ cell count was 521 cells/mm3. At week 24, HIV-1 RNA <50 copies/mL was achieved for 94% of participants in the QD arm and 89% in the BID arm by intent-to-treat, missing = failure analysis (95% confidence interval for difference: > or = 0.29 to +0.18, p = 1.000). At week 24, median CD4+ cell count change from baseline was +26 cells/mm3 for the QD arm and -39 cells/mm3 for BID arm. One patient randomized to the QD arm met virologic failure criteria (confirmed HIV-1 RNA >120 copies/mL) at week 20 and viral genotype showed M184V. After failure, this patient revealed he never took EFV throughout the entire study after randomization, effectively receiving only abacavir/lamivudine/zidovudine qd alone. Median adherence was slightly higher in the QD arm, although both arms had broad variability and overlapping interquartile ranges. Adverse events were infrequent and occurred with similar frequency between arms; treatment-related adverse events were abdominal pain, flatulence, nausea, headache, and abnormal dreams (1 patient [3%] for each adverse event). No patients withdrew due to adverse events, and no abacavir hypersensitivity reactions were reported. In this pilot study of patients suppressed on abacavir/lamivudine/zidovudine bid plus EFV, 94% of participants switching to abacavir/lamivudine/zidovudine qd plus EFV maintained virologic suppression, compared to 89% of participants continuing abacavir/lamivudine/zidovudine bid plus EFV.

Performance Evaluation of a Mobile Touchscreen Interface for Assistive Robotic Manipulators: A Pilot Study.

PubMed

Chung, Cheng-Shiu; Ka, Hyun W; Wang, Hongu; Ding, Dan; Kelleher, Annmarie; Cooper, Rory A

2017-01-01

Background: Assistive robotic manipulators (ARMs) have been developed to provide enhanced assistance and independence in performance of daily activities among people with spinal cord injury when a caregiver is not on site. However, the current commercial ARM user interfaces (UIs) may be difficult to learn and control. A touchscreen mobile UI was developed to overcome these challenges. Objective: The object of this study was to evaluate the performance between 2 ARM UIs, touchscreen and the original joystick, using an ARM evaluation tool (ARMET). Methods: This is a pilot study of people with upper extremity impairments ( N = 8). Participants were trained on 2 UIs, and then they chose one to use when performing 3 tasks on the ARMET: flipping a toggle switch, pushing down a door handle, and turning a knob. Task completion time, mean velocity, and open interviews were the main outcome measurements. Results: Among 8 novice participants, 7 chose the touchscreen UI and 1 chose the joystick UI. All participants could complete the ARMET tasks independently. Use of the touchscreen UI resulted in enhanced ARMET performance (higher mean moving speed and faster task completion). Conclusions: Mobile ARM UIs demonstrated easier learning experience, less physical effort, and better ARMET performance. The improved performance, the accessibility, and lower physical effort suggested that the touchscreen UI might be an efficient tool for the ARM users.

A Pilot Study: Comparison of Arm Versus Ankle Noninvasive Blood Pressure Measurement at 2 Different Levels of Backrest Elevation.

PubMed

Henley, Nicole; Quatrara, Beth D; Conaway, Mark

2015-01-01

Standard practice for obtaining noninvasive blood pressure includes arm blood pressure (BP) cuff placement at the level of the heart; however, some critical care patients cannot have BPs taken in their arm because of various conditions, and ankle BPs are frequently used as substitutes. The aim of this study was to determine if there was a significant variation between upper arm and ankle BP measurements at different backrest elevations with consideration of peripheral edema factors. After institutional review board approval was obtained, a pilot study was implemented to evaluate noninvasive BP measurements of the arm and ankle with backrest elevation at 0° and 30° in a population of medical intensive care unit patients. Participants served as their own controls and were randomly assigned to left- versus right-side BP readings. Data were also collected on presence of arm versus ankle edema. A total of 30 participants enrolled in the study and provided 120 BP measurements. Blood pressure readings were analyzed in terms of diastolic and systolic findings as well as backrest elevations and edema presence. Thirteen participants presented with either arm or ankle edema. There was a statistical difference between the systolic arm and ankle BP measurements in the 0° (P = .008) and 30° (P < .001) backrest elevation positions. The correlation between arm and ankle diastolic BP is greater for participants without ankle edema (P = .038, r = 0.54) than for participants with ankle edema (P = .650, r = 0.14), but it is not statistically significant (P = .47). Even though ankle BPs are often substituted for arm BPs when the arm is unable to be used, ankle BPs and arm BPs are not interchangeable. Adjustments in backrest elevation and considerations of edema do not normalize the differences. Blood pressures obtained from the ankle are significantly greater than those obtained from the arm. This information needs to be considered when arms are not available and legs are used as surrogates for the upper arm.

Pilot evaluation of hypnosis for the treatment of hot flashes in breast cancer survivors.

PubMed

Elkins, Gary; Marcus, Joel; Stearns, Vered; Hasan Rajab, M

2007-05-01

This single arm, pilot study investigated the use of hypnosis to reduce hot flashes in 16 breast cancer survivors. Each patient provided baseline data and received 4 weekly sessions of hypnosis that followed a standardized transcript. Patients were also instructed in self-hypnosis. Throughout the clinical care, patients completed daily diaries of the frequency and severity of their hot flashes. Patients also completed baseline and post-treatment ratings of the degree to which hot flashes interfered with daily activities and quality of life. Results indicated a 59% decrease in total daily hot flashes and a 70% decrease in weekly hot flash scores from their baselines. There was also a significant decrease in the degree to which hot flashes interfered with daily activities for all measures including work, social activities, leisure activities, sleep, mood, concentration, relations with others, sexuality, enjoyment of life, and overall quality of life. This pilot study suggests that clinical hypnosis may be an effective non-hormonal and non-pharmacological treatment for hot flashes. A randomized, controlled clinical trial is planned to more definitively elucidate the efficacy and applicability of hypnosis for reducing hot flashes.

Summary of compliant and multi-arm control at NASA. Langley Research Center

NASA Technical Reports Server (NTRS)

Harrison, Fenton W.

1992-01-01

The topics are presented in viewgraph form and include the: single arm system, single arm axis system, single arm control systems, single arm hand controller axis system, single arm position axis system, single arm vision axis system, single arm force axis system, multi-arm system, multi-arm axis system, and the dual arm hand control axis system with control signals.

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

PubMed

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

2016-03-01

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

Serious games for arm rehabilitation of persons with multiple sclerosis. A randomized controlled pilot study.

PubMed

Jonsdottir, Johanna; Bertoni, Rita; Lawo, Michael; Montesano, Angelo; Bowman, Thomas; Gabrielli, Silvia

2018-01-01

The feasibility and preliminary evidence for efficacy of a serious games platform compared to exergame using the Wii for arm rehabilitation in persons with multiple sclerosis (MS) was investigated. A pilot single-blind randomized (2:1) controlled in clinic trial was carried out. Sixteen persons with MS participated (age years 56.8 (SD 12.3), MS-onset years 19.4 (SD 12.3), EDSS 6.5). Ten participants used a serious games platform (Rehab@Home) while 6 participants played with the commercial Wii platform, for four weeks (40min, 12 sessions/4 weeks). Feasibility and user experience measures were collected. Primary outcomes were the 9 Hole Peg Test (9HPT) and the Box and Block test (BBT). Secondary outcomes were the EQ-5D visual analogue scale (EQ-VAS) and the SF-12. Nonparametric analysis was used to verify changes from pre to post rehabilitation within group and treatment effect was verified with Mann-Whitney U test. P value was set at 0.10 and clinical improvement was set at 20% improvement from baseline. Serious games were perceived positively in terms of user experience and motivation. There were clinically significant improvements in arm function in the serious games group as measured by 9HPT (38-29.5s, P = 0.046, > 20%) and BBT 32-42 cubes, P = 0.19, > 20%) following the 12 gaming sessions while the exergame group did not improve on either test (9HPT 34.5-41.5s, P = 0.34; BBT 38,5 to 42 cubes, P = 0.34). Only the exergame group perceived themselves as having improved their health. There was a significant between groups treatment effect only in perception of health (EQ-VAS) (Z = 1.93, P = 0.06) favouring the exergame group. Virtual reality in a serious gaming approach was feasible and beneficial to arm function of persons with MS but motivational aspects of the approach may need further attention. Copyright © 2017 Elsevier B.V. All rights reserved.

Unmanned Aerial Vehicles and Weapons of Mass Destruction: A Lethal Combination?

DTIC Science & Technology

1997-08-01

assessment ( BDA ), where they allow armed forces to avoid placing pilots at risk. They have also been used to gather nonmilitary information in... BDA purposes. In fact, the Pioneer UAV was praised as "the single most valuable intelligence collector" in the war against Iraq.6 They have proved to...carries half the weapon’s total energy. Finally, as the explosion takes on the familiar " mushroom " shape, winds suck back into the cloud, adding to the

Using the MEDiPORT humanoid robot to reduce procedural pain and distress in children with cancer: A pilot randomized controlled trial.

PubMed

Jibb, Lindsay A; Birnie, Kathryn A; Nathan, Paul C; Beran, Tanya N; Hum, Vanessa; Victor, J Charles; Stinson, Jennifer N

2018-06-12

Subcutaneous port needle insertions are painful and distressing for children with cancer. The interactive MEDiPORT robot has been programmed to implement psychological strategies to decrease pain and distress during this procedure. This study assessed the feasibility of a future MEDiPORT trial. The secondary aim was to determine the preliminary effectiveness of MEDiPORT in reducing child pain and distress during subcutaneous port accesses. This 5-month pilot randomized controlled trial used a web-based service to randomize 4- to 9-year-olds with cancer to the MEDiPORT cognitive-behavioral arm (robot using evidence-based cognitive-behavioral interventions) or active distraction arm (robot dancing and singing) while a nurse conducted a needle insertion. We assessed accrual and retention; technical difficulties; outcome measure completion by children, parents, and nurses; time taken to complete the study and clinical procedure; and child-, parent-, and nurse-rated acceptability. Descriptive analyses, with exploratory inferential testing of child pain and distress data, were used to address study aims. Forty children were randomized across study arms. Most (85%) eligible children participated and no children withdrew. Technical difficulties were more common in the cognitive-behavioral arm. Completion times for the study and needle insertion were acceptable and >96% of outcome measure items were completed. Overall, MEDiPORT and the study were acceptable to participants. There was no difference in pain between arms, but distress during the procedure was less pronounced in the active distraction arm. The MEDiPORT study appears feasible to implement as an adequately-powered effectiveness-assessing trial following modifications to the intervention and study protocol. ClinicalTrials.gov NCT02611739. © 2018 Wiley Periodicals, Inc.

VizieR Online Data Catalog: Southern H II Region Discovery Survey: pilot survey (Brown+, 2017)

NASA Astrophysics Data System (ADS)

Brown, C.; Jordan, C.; Dickey, J. M.; Anderson, L. D.; Armentrout, W. P.; Balser, D. S.; Bania, T. M.; Dawson, J. R.; Mc Clure-Griffiths, N. M.; Wenger, T. V.

2018-05-01

The Southern H II Region Discovery Survey (SHRDS) is a multi-year project using the Australia Telescope Compact Array (ATCA) to complement the GBT and Arecibo HRDS by extending the survey area into the southern sky (δ<-45°). This area includes the Southern end of the Galactic Bar, the Near and Far 3 kpc Arms, the Norma/Cygnus Arm, the Scutum/Crux Arm, the Sagitttarius/Carina Arm, and outside the solar circle, the Perseus Arm, and the Outer Arm. All pilot SHRDS observations used the ATCA in the five antenna H75 array configuration, giving a nominal maximum baseline of 75 m and a beam size of FWHM ~65" at 7.8 GHz depending on the declination and hour angles of the observations. The SHRDS pilot observations were done in two sessions. Epoch I, observed 2013 June 30, focused on candidates that were expected to show bright radio recombination line (RRL) detections, which they did. Epoch II, observed 2014 June 26 and 27, used a list of candidates with expected flux densities typical of the SHRDS catalog as a whole. The two epochs also used different longitude ranges in order to generate samples of H II regions with different Galactic radii. (3 data files).

The herbal medicine daikenchuto ameliorates an impaired anorectal motor activity in postoperative pediatric patients with an anorectal malformation--a pilot study.

PubMed

Takagi, Akiko; Yagi, Minoru; Tanaka, Yoshiaki; Asagiri, Kimio; Asakawa, Takahiro; Tanaka, Hiroaki; Ishii, Shinji; Egami, Hideaki; Akaiwa, Masao; Tsuru, Tomomitsu

2010-01-01

Fecoflowmetry (FFM) has been introduced to simulate natural anorectal evacuation. So far, few reports have described the effect of the herbal medicine Daikenchuto (DKT) on impaired anorectal motor function. The aim of this pilot study was to assess anorectal motor function by FFM in postoperatively impaired patients with an anorectal malformation (ARM) before and after administration of DKT. Six postoperative patients with ARM (mean age, 7.8 years) who complained of intractable constipation with soiling in spite of administration of magnesia as a laxative were assessed over an extended period. These patients received 0.3 g/kg/d of DKT for an average of 128 days. Evacuative rate and maximum fecal stream flow were seen to increase significantly after administration of DKT when compared with values before administration of DKT. In conclusion, DKT had a favorable clinical effect on anorectal motor function in postoperative patients with ARM.

Red blood cell transfusion triggers in acute leukemia: a randomized pilot study.

PubMed

DeZern, Amy E; Williams, Katherine; Zahurak, Marianna; Hand, Wesley; Stephens, R Scott; King, Karen E; Frank, Steven M; Ness, Paul M

2016-07-01

Red blood cell (RBC) transfusion thresholds have yet to be examined in large randomized trials in hematologic malignancies. This pilot study in acute leukemia uses a restrictive compared to a liberal transfusion strategy. A randomized (2:1) study was conducted of restrictive (LOW) hemoglobin (Hb) trigger (7 g/dL) compared to higher (HIGH) Hb trigger (8 g/dL). The primary outcome was feasibility of conducting a larger trial. The four requirements for success required that more than 50% of the eligible patients could be consented, more than 75% of the patients randomized to the LOW arm tolerated the transfusion trigger, fewer than 15% of patients crossed over from the LOW arm to the HIGH arm, and no indication for the need to pause the study for safety concerns. Secondary outcomes included fatigue, bleeding, and RBCs and platelets transfused. Ninety patients were consented and randomly assigned to LOW to HIGH. The four criteria for the primary objective of feasibility were met. When the number of units transfused was compared, adjusting for baseline Hb, the LOW arm was transfused on average 8.0 (95% confidence interval [CI], 6.9-9.1) units/patient while the HIGH arm received 11.7 (95% CI, 10.1-13.2) units (p = 0.0003). There was no significant difference in bleeding events or neutropenic fevers between study arms. This study establishes feasibility for trial of Hb thresholds in leukemia through demonstration of success in all primary outcome metrics and a favorable safety profile. This population requires further study to evaluate the equivalence of liberal and restrictive transfusion thresholds in this unique clinical setting. © 2016 AABB.

A randomized study of remote monitoring and fluid monitoring for the management of patients with implanted cardiac arrhythmia devices.

PubMed

Lüthje, Lars; Vollmann, Dirk; Seegers, Joachim; Sohns, Christian; Hasenfuß, Gerd; Zabel, Markus

2015-08-01

Only limited comparative data exist on the benefits of fluid monitoring (FM) combined with remote monitoring (RM) regarding morbidity and mortality of heart failure (HF) patients. This prospective single-centre randomized pilot study aimed to estimate the influence of RM in combination with FM on HF hospitalizations as well as ventricular tachyarrhythmias and mortality. Patients with standard indication for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy and defibrillator were implanted with devices capable of RM and FM, and were followed for 15 months. Subjects were randomly allocated to RM including OptiVol and predefined management of alerts (remote group), or standard in-office visits every 3 months (control group). A total of 176 patients (77% male; 66 ± 12 years; left ventricular ejection fraction (LVEF) 32 ± 11%; ischemic cardiomyopathy 50%; CRT device 50%; primary prevention 85%) were analysed. Cox proportional hazard analysis on the time to first HF-related hospitalization showed a hazard ratio of 1.23 [0.62-2.44] (P = 0.551) favouring the control group. In the remote group, 13 patients (15%) experienced ICD shocks vs. 10 patients (11%) in the control group (P = 0.512). The average time to first ICD shock was 212 ± 173 days in the remote arm and 212 ± 143 days in the control arm (P = 0.994). The Kaplan-Meier estimate of mortality after 1 year was 8.6% (eight deaths) in the remote group vs. 4.6% in the control group (six deaths; P = 0.502). In a single-centre randomized pilot study of RM in combination with FM, no significant influence on HF-related hospitalizations, ICD shocks, or mortality was found. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

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

PubMed

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

2014-05-01

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

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

PubMed

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

2017-10-01

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

Development and Piloting of a Home-Based Couples Intervention During Pregnancy and Postpartum in Southwestern Kenya.

PubMed

Turan, Janet M; Darbes, Lynae A; Musoke, Pamela L; Kwena, Zachary; Rogers, Anna Joy; Hatcher, Abigail M; Anderson, Jami L; Owino, George; Helova, Anna; Weke, Elly; Oyaro, Patrick; Bukusi, Elizabeth A

2018-03-01

Engaging both partners of a pregnant couple can enhance prevention of mother-to-child transmission of HIV and promote family health. We developed and piloted an intervention to promote couple collaboration in health during pregnancy and postpartum in southwestern Kenya. We utilized formative data and stakeholder input to inform development of a home-based couples intervention. Next, we randomized pregnant women to intervention (n = 64) or standard care (n = 63) arms, subsequently contacting their male partners for enrollment. In the intervention arm, lay health workers conducted couple home visits, including health education, couple relationship and communication skills, and offers of couple HIV testing and counseling (CHTC) services. Follow-up questionnaires were conducted 3 months postpartum (n = 114 women, 86 men). Baseline characteristics and health behaviors were examined by study arm using t-tests, chi-square tests, and regression analyses. Of the 127 women randomized, 96 of their partners participated in the study. Of 52 enrolled couples in the intervention arm, 94% completed at least one couple home visit. Over 93% of participants receiving couple home visits were satisfied and no adverse social consequences were reported. At follow-up, intervention couples had a 2.78 relative risk of having participated in CHTC during the study period compared with standard care couples (95% confidence interval: 1.63-4.75), and significant associations were observed in other key perinatal health behaviors. This pilot study revealed that a home-based couples intervention for pregnant women and male partners is acceptable, feasible, and has the potential to enhance CHTC and perinatal health behaviors, leading to improved health outcomes.

A mixed method pilot study: the researchers' experiences.

PubMed

Secomb, Jacinta M; Smith, Colleen

2011-08-01

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

Bristol girls dance project feasibility study: using a pilot economic evaluation to inform design of a full trial

PubMed Central

Powell, Jane E; Carroll, Fran E; Sebire, Simon J; Haase, Anne M; Jago, Russell

2013-01-01

Background There is currently little guidance for pilot trial economic evaluation where health outcomes and costs are influenced by a range of wider determinants and factors. Objectives This article presents the findings of a pilot economic evaluation study running alongside the Bristol Girls Dance Project (BGDP) feasibility study. Design 3-arm, cluster randomised, controlled pilot trial and economic evaluation. 7 schools (n=210) from the Bristol and greater Bristol area, UK were randomly allocated to the intervention arm 3 schools (n=90) and the control arm 4 schools (n=120). Intervention Girls aged 11–12 years with parental consent were provided with two, 90 min dance sessions per week for 9 weeks at school facilities. Economic outcome measures Programme costs and girls’ preferences for attributes of dance and preferences for competing leisure time activities were measured. Results The mainstream average cost of the BGDP programme (not including research, control and dance teacher training costs) per school was $2126.40, £1329 and €1555 and per participant was $70.90, £44.31 and €51.84 in 2010–2011 prices. Discrete choice experiment (DCE) methods are acceptable to girls of this age indicating time available for other leisure activities on dance class days is the attribute girls valued most and 2 h leisure time remaining preferred to 3 h. Conclusions This pilot study indicates that providing full cost data for a future trial of the BGDP programme is feasible and practical. There is no evidence from preference data to support adjustment to intervention design. A future economic evaluation is likely to be successful utilising the resource use checklist developed. The importance of categorising separately resources used to develop, prepare, deliver and maintain the programme to estimate mainstream costs accurately is demonstrated. PMID:24362013

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 ).

Developing and testing accelerated partner therapy for partner notification for people with genital Chlamydia trachomatis diagnosed in primary care: a pilot randomised controlled trial

PubMed Central

Estcourt, Claudia S; Sutcliffe, Lorna J; Copas, Andrew; Mercer, Catherine H; Roberts, Tracy E; Jackson, Louise J; Symonds, Merle; Tickle, Laura; Muniina, Pamela; Rait, Greta; Johnson, Anne M; Aderogba, Kazeem; Creighton, Sarah; Cassell, Jackie A

2015-01-01

Background Accelerated partner therapy (APT) is a promising partner notification (PN) intervention in specialist sexual health clinic attenders. To address its applicability in primary care, we undertook a pilot randomised controlled trial (RCT) of two APT models in community settings. Methods Three-arm pilot RCT of two adjunct APT interventions: APTHotline (telephone assessment of partner(s) plus standard PN) and APTPharmacy (community pharmacist assessment of partner(s) plus routine PN), versus standard PN alone (patient referral). Index patients were women diagnosed with genital chlamydia in 12 general practices and three community contraception and sexual health (CASH) services in London and south coast of England, randomised between 1 September 2011 and 31 July 2013. Results 199 women described 339 male partners, of whom 313 were reported by the index as contactable. The proportions of contactable partners considered treated within 6 weeks of index diagnosis were APTHotline 39/111 (35%), APTPharmacy 46/100 (46%), standard patient referral 46/102 (45%). Among treated partners, 8/39 (21%) in APTHotline arm were treated via hotline and 14/46 (30%) in APTPharmacy arm were treated via pharmacy. Conclusions The two novel primary care APT models were acceptable, feasible, compliant with regulations and capable of achieving acceptable outcomes within a pilot RCT but intervention uptake was low. Although addition of these interventions to standard PN did not result in a difference between arms, overall PN uptake was higher than previously reported in similar settings, probably as a result of introducing a formal evaluation. Recruitment to an individually randomised trial proved challenging and full evaluation will likely require service-level randomisation. Trial registration number Registered UK Clinical Research Network Study Portfolio id number 10123. PMID:26019232

Charter for the ARM Atmospheric Modeling Advisory Group

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

Advisory Group, ARM Atmospheric Modeling

The Atmospheric Modeling Advisory Group of the U.S. Department of Energy (DOE) Atmospheric Radiation Measurement (ARM) Climate Research Facility is guided by the following: 1. The group will provide feedback on the overall project plan including input on how to address priorities and trade-offs in the modeling and analysis workflow, making sure the modeling follows general best practices, and reviewing the recommendations provided to ARM for the workflow implementation. 2. The group will consist of approximately 6 members plus the PI and co-PI of the Large-Eddy Simulation (LES) ARM Symbiotic Simulation and Observation (LASSO) pilot project. The ARM Technical Director,more » or his designee, serves as an ex-officio member. This size is chosen based on the ability to efficiently conduct teleconferences and to span the general needs for input to the LASSO pilot project.« less

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

Rotating mobile launcher

NASA Technical Reports Server (NTRS)

Gregory, T. J.

1977-01-01

Apparatus holds remotely piloted arm that accelerates until launching speed is reached. Then vehicle and counterweight at other end of arm are released simultaneously to avoid structural damage from unbalanced rotating forces.

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 community health worker intervention to improve management of hypertension among Filipino Americans in New York and New Jersey: a pilot study.

PubMed

Ursua, Rhodora A; Aguilar, David E; Wyatt, Laura C; Katigbak, Carina; Islam, Nadia S; Tandon, S Darius; Nur, Potri Ranka Manis Queano; Van Devanter, Nancy; Rey, Mariano J; Trinh-Shevrin, Chau

2014-01-01

The purpose of the pilot study was to assess the feasibility and efficacy of a 4-month community health worker (CHW) intervention to improve hypertension management among Filipino immigrants in New York and New Jersey. Single-arm CHW pilot intervention using a pre-post design delivered by 5 CHWs. New York City, NY and Jersey City, NJ. Of 88 Filipino individuals recruited for the study, 39 received the full pilot intervention, 18 received a partial intervention, and 31 dropped out; 13 Filipino participants, 10 CHW Trainers, and 3 Filipino CHWs were interviewed for qualitative analysis. Individuals participated in 4 workshops related to hypertension management and cardiovascular disease (CVD) risk factors and received monthly in-person visits, and twice monthly phone calls individually from a CHW. Primary outcomes included blood pressure (BP) reduction and control, appointment keeping, and medication adherence; secondary outcomes included weight, body mass index (BMI), self-efficacy related to diet, exercise, and medication taking, CVD knowledge, and nutrition (salt/ sodium and cholesterol/fat). A mixed method analysis was used to assess the intervention, utilizing quantitative and qualitative methods. By the end of the intervention, significant changes were exhibited for systolic and diastolic BP, weight, and BMI (P<.01). Significant changes were not seen for medication adherence and appointment keeping, however, CVD knowledge and self-efficacy related to diet and weight management all improved significantly (P<.01). Qualitative findings provided additional information on the acceptability, feasibility, and efficacy of the intervention. This pilot CHW intervention showed evidence of feasibility, as well as efficacy, in improving hypertension management and reducing CVD factors in Filipino Americans.

COOL-ARREST: Results from a Pilot Multicenter, Prospective, Single-Arm Observational Trial to Assess Intravascular Temperature Management in the Treatment of Cardiac Arrest.

PubMed

Sawyer, Kelly N; Mooney, Michael; Norris, Gregory; Devlin, Thomas; Lundbye, Justin; Doshi, Pratik B; Hewett, Jonathan Kyle; Kono, Alan T; Jorgensen, Jesse P; O'Neil, Brian J

2018-06-08

Targeted temperature management (TTM) is recommended postcardiac arrest. The cooling method with the highest safety and efficacy is unknown. The COOL-ARREST pilot trial aimed to evaluate the safety and efficacy of the most contemporary ZOLL Thermogard XP Intravascular Temperature Management (IVTM) system for providing mild TTM postcardiac arrest. This multicenter, prospective, single-arm, observational pilot trial enrolled patients at eight U.S. hospitals between July 28, 2014, and July 24, 2015. Adult (≥18 years old), out-of-hospital cardiac arrest subjects of presumed cardiac etiology who achieved return of spontaneous circulation (ROSC) were considered for inclusion. Patients were excluded if (1) awake or consistently following commands after ROSC, (2) significant prearrest neurological dysfunction, (3) terminal illness or advanced directives precluding aggressive care, and (4) severe hemodynamic instability or shock. Patient temperature was maintained at 33.0°C ± 0.3°C for a total of 24 hours followed by controlled rewarming (0.1-0.2°C/h). Logistic regressions were used to assess association of good functional outcome (modified Rankin Scale ≤3) measured at the time of hospital discharge with shockable rhythm (yes/no), age, gender, race/ethnicity, lay-rescuer cardiopulmonary resuscitation, time to basic life support (minutes), time to ROSC (minutes), lactate (mg/dL), and pH on admission. The ZOLL IVTM system was effective at inducing TTM (median time to target temperature from initiation, 89 minutes [interquartile range 42-155]). Adverse events most often included electrolyte abnormalities and dysrhythmias. Of patients surviving to hospital discharge, 16/20 patients had a good functional outcome. A total of 18 patients survived through 90-day follow-up, at which time 94% (17/18) of patients had good functional outcome. The COOL-ARREST pilot trial demonstrates high safety and efficacy of the ZOLL Thermogard XP IVTM system in the application of mild TTM postcardiac arrest. This observational trial also revealed noteworthy variability in the management of postcardiac arrest patients, particularly with the use of early withdrawal of life-sustaining therapy.

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

NASA Technical Reports Server (NTRS)

Weislogel, G. S.

1983-01-01

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

Kelston Beverages Pilot Study: Rationale, design and implementation of a community and school based intervention to reduce sugary drink consumption among children and youth.

PubMed

Sundborn, G; Ni Mhurchu, C; Ness, C; Latu, H; Jackson, R

2014-03-01

The Kelston Beverages Study was designed to increase awareness of the sugar content of sugary drinks, the poor health consequences that high intake of these drinks have, and inform on ways to reduce intake of students. The aims of this pilot study were to refine interventions and processes designed to raise awareness of the harms that sugar sweetened beverages (SSBs) have on health, and to reduce their consumption among the youth of a small West Auckland suburb. There were three arms to this interventional study, one in schools, another in community organisations (churches, sports clubs and community groups), and the final arm is in the local retail sector. The school arm was the most extensive component and initially involved a survey of children's knowledge and consumption of sugar sweetened beverages (SSBs) using a brief questionnaire. The study evaluated any SSB policies in schools and for schools that did not have policies, opportunities were scoped to develop and implement them; a canteen AUDIT focussed particularly on beverages was carried out; and finally a student partnered social marketing exercise was undertaken that comprised 2 competitions, one to design a poster, and another to write and perform a rap. Children were re-surveyed at the completion of the intervention (7 months later) to determine change in knowledge and self-reported consumption of SSBs. Both the community organisations and retail arms of this study focussed on raising awareness into the harmful effects of SSBs and establishing healthy beverage policy in the respective organisations. Promising results with regards to acceptability, feasibility, and recruitment as well as valuable learnings with regard to process support the development of a proposal to conduct a cluster randomised trial of the interventions successfully tested in this pilot study.

Evaluation of Two Unique Side Stick Controllers in a Fixed-Base Flight Simulator

NASA Technical Reports Server (NTRS)

Mayer, Jann; Cox, Timothy H.

2003-01-01

A handling qualities analysis has been performed on two unique side stick controllers in a fixed-base F-18 flight simulator. Each stick, which uses a larger range of motion than is common for similar controllers, has a moving elbow cup that accommodates movement of the entire arm for control. The sticks are compared to the standard center stick in several typical fighter aircraft tasks. Several trends are visible in the time histories, pilot ratings, and pilot comments. The aggressive pilots preferred the center stick, because the side sticks are underdamped, causing overshoots and oscillations when large motions are executed. The less aggressive pilots preferred the side sticks, because of the smooth motion and low breakout forces. The aggressive pilots collectively gave the worst ratings, probably because of increased sensitivity of the simulator (compared to the actual F-18 aircraft), which can cause pilot-induced oscillations when aggressive inputs are made. Overall, the elbow cup is not a positive feature, because using the entire arm for control inhibits precision. Pilots had difficulty measuring their performance, particularly during the offset landing task, and tended to overestimate.

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

NASA Technical Reports Server (NTRS)

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

2013-01-01

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

Randomized controlled trial of a dose consolidation program.

PubMed

Delate, Thomas; Fairman, Kathleen A; Carey, Shelly M; Motheral, Brenda R

2004-01-01

To evaluate the effectiveness and financial impact of a drug dose consolidation (optimization) program using letter intervention. This pilot program in a large, mid-Atlantic health plan utilized a randomized controlled trial research design. A review of adjudicated pharmacy claims records was performed monthly for 3 consecutive months from November 2002 through February 2003 to identify inefficient (i.e., >once-daily) regimens for any one of 68 dosage strengths of 37 single-source maintenance drugs with once-daily dosing recommendations. Prescribers who had prescribed one or more inefficient regimens were identified and randomized to one of the 2 intervention arms or a control arm. Prescribers in both intervention arms were sent personalized letters with information on their patients. inefficient regimens and suggested dose consolidation options. Patients of prescribers in one intervention arm received a complementary, patient-oriented letter. Pharmacy claims for patients in all arms were examined at 180 days after the date of the letter mailing for conversion to an efficient (once-daily) regimen. Financial modeling analysis calculated net savings as changes in pharmacy expenditures minus administrative costs. A total of 2,614 inefficient regimens, representing 6.7% of claims for the targeted medications, were identified. The rate of consolidation to a suggested dosing option was lower for the Physician Letter arm (7.3%) than for the Physician/Member Letter arm (10.2%) (P = 0.046). Both intervention arms had higher consolidation rates than the Control arm (3.9%) (P = 0.018 and P = 0.000, respectively.). Approximately 30% of the regimens in each study arm were never refilled after being targeted. Financial modeling indicated that a dose consolidation intervention could save 0.03 dollars to 0.07 dollars per member per month (PMPM) in 2003 dollars with full medication compliance but only 0.02 dollars to 0.03 dollars PMPM when savings were calculated with realistic, partial compliance rates. Subanalyses performed at the drug therapy class level revealed few opportunities to justify implementing a dose consolidation program. After taking into consideration program administrative costs, high rates of refill discontinuation, and dose consolidation that occurs naturally without intervention, the results indicated that a letter-based dose consolidation program did not appreciably decrease pharmacy expenditures.

An arm wearable haptic interface for impact sensing on unmanned aerial vehicles

NASA Astrophysics Data System (ADS)

Choi, Yunshil; Hong, Seung-Chan; Lee, Jung-Ryul

2017-04-01

In this paper, an impact monitoring system using fiber Bragg grating (FBG) sensors and vibro-haptic actuators has been introduced. The system is suggested for structural health monitoring (SHM) for unmanned aerial vehicles (UAVs), by making a decision with human-robot interaction. The system is composed with two major subsystems; an on-board system equipped on UAV and an arm-wearable interface for ground pilot. The on-board system acquires impact-induced wavelength changes and performs localization process, which was developed based on arrival time calculation. The arm-wearable interface helps ground pilots to make decision about impact location themselves by stimulating their tactile-sense with motor vibration.

77 FR 40023 - 36(b)(1) Arms Sales Notification

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-06

... vision goggle compatible and sun light readable. The pilots and aircrew have common programmable keysets... pilots and aircrew have common programmable keysets, a mass memory unit, mission and flight management...

Does combined strength training and local vibration improve isometric maximum force? A pilot study.

PubMed

Goebel, Ruben; Haddad, Monoem; Kleinöder, Heinz; Yue, Zengyuan; Heinen, Thomas; Mester, Joachim

2017-01-01

The aim of the study was to determine whether a combination of strength training (ST) and local vibration (LV) improved the isometric maximum force of arm flexor muscles. ST was applied to the left arm of the subjects; LV was applied to the right arm of the same subjects. The main aim was to examine the effect of LV during a dumbbell biceps curl (Scott Curl) on isometric maximum force of the opposite muscle among the same subjects. It is hypothesized, that the intervention with LV produces a greater gain in isometric force of the arm flexors than ST. Twenty-seven collegiate students participated in the study. The training load was 70% of the individual 1 RM. Four sets with 12 repetitions were performed three times per week during four weeks. The right arm of all subjects represented the vibration trained body side (VS) and the left arm served as the traditional trained body side (TTS). A significant increase of isometric maximum force in both body sides (Arms) occurred. VS, however, significantly increased isometric maximum force about 43% in contrast to 22% of the TTS. The combined intervention of ST and LC improves isometric maximum force of arm flexor muscles. III.

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

PubMed

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

2017-08-01

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

A randomized controlled pilot study of VO2 max testing: a potential model for measuring relative in vivo efficacy of different red blood cell products.

PubMed

Bennett-Guerrero, Elliott; Lockhart, Evelyn L; Bandarenko, Nicholas; Campbell, Mary L; Natoli, Michael J; Jamnik, Veronika K; Carter, Timothy R; Moon, Richard E

2017-03-01

Randomized trials, for example, RECESS, comparing "young" (median, 7-day) versus "middle-aged" (median, 28-day) red blood cells (RBCs), showed no difference in outcome. These data are important; however, they do not inform us about the safety and effectiveness of the oldest RBCs, which some patients receive. It may not be feasible to conduct a clinical trial randomizing patients to receive the oldest blood. Therefore, we propose strenuous exercise (VO 2 max testing) as a model to study the relative efficacy to increase oxygen delivery to tissue of different RBC products, for example, extremes of storage duration. In this pilot study, eight healthy subjects had 2 units of leukoreduced RBCs collected by apheresis in AS-3 using standard methods. Subjects were randomized to receive both (2) units of their autologous RBCs at either 7 or 42 days after blood collection. VO 2 max testing on a cycle ergometer was performed 2 days before (Monday) and 2 days after (Friday) the transfusion visit (Wednesday). This design avoids confounding effects on intravascular volume from the 2-unit blood transfusion. The primary outcome was the difference in VO 2 max between Friday and Monday (delta VO 2 max). VO 2 max increased more in the 7-day RBC arm (8.7 ± 6.9% vs. 1.9 ± 6.5%, p = 0.202 for comparison between arms). Exercise duration (seconds) increased in the 7-day RBC arm (8.4 ± 1.7%) but actually decreased in the 42-day arm (-2.6 ± 3.6%, p = 0.002). This pilot study suggests that VO 2 max testing has potential as a rigorous and quantitative in vivo functional assay of RBC function. Our preliminary results suggest that 42-day RBCs are inferior to 7-day RBCs at delivering oxygen to tissues. © 2016 AABB.

The Effects of Continuous One-Arm Kettlebell Swing Training on Physiological Parameters in United States Air Force Personnel: A Pilot Study

DTIC Science & Technology

2016-11-01

collegiate soccer players . KB snatches were performed 3 days per week for 20 minutes with 15-second work-to-rest intervals, while the control group...10] used KB weights that were 18% of total body mass and reported a 6% improvement in aerobic capacity in women’s collegiate soccer players who...Force Personnel: A Pilot Study Molly Wade, MS; Reginald O’Hara, PhD; Lydia Caldwell, MS; Jason Ordway, MS; Darryn Bryant, MS

Integrating a Nurse-Midwife-Led Oral Health Intervention Into CenteringPregnancy Prenatal Care: Results of a Pilot Study.

PubMed

Adams, Sally H; Gregorich, Steven E; Rising, Sharon S; Hutchison, Margaret; Chung, Lisa H

2017-07-01

National and professional organizations recommend oral health promotion in prenatal care to improve women's oral health. However, few prenatal programs include education about oral health promotion. The objective of this study was to determine if women receiving a brief, low-cost, and sustainable educational intervention entitled CenteringPregnancy Oral Health Promotion had clinically improved oral health compared to women receiving standard CenteringPregnancy care. Women attending CenteringPregnancy, a group prenatal care model, at 4 health centers in the San Francisco Bay Area, participated in this nonrandomized controlled pilot study in 2010 to 2011. The intervention arm received the CenteringPregnancy Oral Health Promotion intervention consisting of two 15-minute skills-based educational modules addressing maternal and infant oral health, each module presented in a separate CenteringPregnancy prenatal care session. The present analysis focused on the maternal module that included facilitated discussions and skills-building activities including proper tooth brushing. The control arm received standard CenteringPregnancy prenatal care. Dental examinations and questionnaires were administered prior to and approximately 9 weeks postintervention. Primary outcomes included the Plaque Index, percent bleeding on probing, and percent of gingival pocket depths 4 mm or greater. Secondary outcomes were self-reported oral health knowledge, attitudes (importance and self-efficacy), and behaviors (tooth brushing and flossing). Regression models tested whether pre to post changes in outcomes differed between the intervention versus the control arms. One hundred and one women participated in the study; 49 were in the intervention arm, and 52 were in the control arm. The control and intervention arms did not vary significantly at baseline. Significant pre to post differences were noted between the arms with significant improvements in the intervention arm for the Plaque Index, bleeding on probing, and pocket depths 4 mm or greater. Providing brief oral health education and skills-building activities within prenatal care may be effective in improving women's oral health during pregnancy. These findings provide support for developing a full-scale randomized clinical trial of the CenteringPregnancy Oral Health Promotion intervention. © 2017 by the American College of Nurse-Midwives.

A pilot study of serotonergic modulation after long-term administration of oxytocin in autism spectrum disorder.

PubMed

Hirosawa, Tetsu; Kikuchi, Mitsuru; Ouchi, Yasuomi; Takahashi, Tetsuya; Yoshimura, Yuko; Kosaka, Hirotaka; Furutani, Naoki; Hiraishi, Hirotoshi; Fukai, Mina; Yokokura, Masamichi; Yoshikawa, Etsuji; Bunai, Tomoyasu; Minabe, Yoshio

2017-05-01

Oxytocin (OT) and the serotonergic system putatively play important roles in autism spectrum disorder (ASD) etiology and symptoms, but no direct neurobiological evidence exists for long-term OT administration effects on the brain's serotonergic system. This pilot study examined 10 male participants with ASD who were administered OT intranasally for 8-10 weeks in an open-label, single-arm, nonrandomized, and uncontrolled manner. Positron emission tomography (PET) with a radiotracer ( 11 C)-3-amino-4-(2-[(dimethylamino)methyl]phenylthio)benzonitrile ( 11 C-DASB) was used before and after OT treatment. The binding potential of serotonin transporter ( 11 C-DASB BP ND ) was then estimated. The main outcome measures were changes in 11 C-DASB BP ND and their correlation with changes in symptoms. ASD participants showed significantly elevated 11 C-DASB BP ND in the left inferior frontal gyrus extending to the left middle frontal gyrus. No significant correlation was found between the change in any clinical symptom and the change in 11 C-DASB BP ND . This report of a pilot study is the first describing long-term effects of OT on the brain's serotonin system in ASD. Additional randomized controlled studies must be conducted to confirm whether activation of the serotonergic system contributes to the prosocial effect of OT in people with ASD. Autism Res 2017, 10: 821-828. © 2017 International Society for Autism Research, Wiley Periodicals, Inc. © 2017 International Society for Autism Research, Wiley Periodicals, Inc.

Developing and testing accelerated partner therapy for partner notification for people with genital Chlamydia trachomatis diagnosed in primary care: a pilot randomised controlled trial.

PubMed

Estcourt, Claudia S; Sutcliffe, Lorna J; Copas, Andrew; Mercer, Catherine H; Roberts, Tracy E; Jackson, Louise J; Symonds, Merle; Tickle, Laura; Muniina, Pamela; Rait, Greta; Johnson, Anne M; Aderogba, Kazeem; Creighton, Sarah; Cassell, Jackie A

2015-12-01

Accelerated partner therapy (APT) is a promising partner notification (PN) intervention in specialist sexual health clinic attenders. To address its applicability in primary care, we undertook a pilot randomised controlled trial (RCT) of two APT models in community settings. Three-arm pilot RCT of two adjunct APT interventions: APTHotline (telephone assessment of partner(s) plus standard PN) and APTPharmacy (community pharmacist assessment of partner(s) plus routine PN), versus standard PN alone (patient referral). Index patients were women diagnosed with genital chlamydia in 12 general practices and three community contraception and sexual health (CASH) services in London and south coast of England, randomised between 1 September 2011 and 31 July 2013. 199 women described 339 male partners, of whom 313 were reported by the index as contactable. The proportions of contactable partners considered treated within 6 weeks of index diagnosis were APTHotline 39/111 (35%), APTPharmacy 46/100 (46%), standard patient referral 46/102 (45%). Among treated partners, 8/39 (21%) in APTHotline arm were treated via hotline and 14/46 (30%) in APTPharmacy arm were treated via pharmacy. The two novel primary care APT models were acceptable, feasible, compliant with regulations and capable of achieving acceptable outcomes within a pilot RCT but intervention uptake was low. Although addition of these interventions to standard PN did not result in a difference between arms, overall PN uptake was higher than previously reported in similar settings, probably as a result of introducing a formal evaluation. Recruitment to an individually randomised trial proved challenging and full evaluation will likely require service-level randomisation. Registered UK Clinical Research Network Study Portfolio id number 10123. 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/

Effectiveness of a Mindfulness-Based Childbirth Education pilot study on maternal self-efficacy and fear of childbirth.

PubMed

Byrne, Jean; Hauck, Yvonne; Fisher, Colleen; Bayes, Sara; Schutze, Robert

2014-01-01

This pilot study tested the feasibility and effectiveness of using Mindfulness-Based Childbirth Education (MBCE), a novel integration of mindfulness meditation and skills-based childbirth education, for mental health promotion with pregnant women. The MBCE protocol aimed to reduce fear of birth, anxiety, and stress and improve maternal self-efficacy. This pilot study also aimed to determine the acceptability and feasibility of the MBCE protocol. A single-arm pilot study of the MBCE intervention using a repeated-measures design was used to analyze data before and after the MBCE intervention to determine change trends with key outcome variables: mindfulness; depression, anxiety, and stress; childbirth self-efficacy; and fear of childbirth. Pregnant women (18-28 weeks' gestation) and their support companions attended weekly MBCE group sessions over 8 weeks in an Australian community setting. Of the 18 women who began and completed the intervention, missing data allowed for complete data from 12 participants to be analyzed. Statistically significant improvements and large effect sizes were observed for childbirth self-efficacy and fear of childbirth. Improvements in depression, mindfulness, and birth outcome expectations were underpowered. At postnatal follow-up significant improvements were found in anxiety, whereas improvements in mindfulness, stress, and fear of birth were significant at a less conservative alpha level. This pilot study demonstrated that a blended mindfulness and skills-based childbirth education intervention was acceptable to women and was associated with improvements in women's sense of control and confidence in giving birth. Previous findings that low self-efficacy and high childbirth fear are linked to greater labor pain, stress reactivity, and trauma suggest the observed improvements in these variables have important implications for improving maternal mental health and associated child health outcomes. Ways in which these outcomes can be achieved through improved childbirth education are discussed. © 2013 by the American College of Nurse-Midwives.

Randomized ablation strategies for the treatment of persistent atrial fibrillation: RASTA study.

PubMed

Dixit, Sanjay; Marchlinski, Francis E; Lin, David; Callans, David J; Bala, Rupa; Riley, Michael P; Garcia, Fermin C; Hutchinson, Mathew D; Ratcliffe, Sarah J; Cooper, Joshua M; Verdino, Ralph J; Patel, Vickas V; Zado, Erica S; Cash, Nancy R; Killian, Tony; Tomson, Todd T; Gerstenfeld, Edward P

2012-04-01

The single-procedure efficacy of pulmonary vein isolation (PVI) is less than optimal in patients with persistent atrial fibrillation (AF). Adjunctive techniques have been developed to enhance single-procedure efficacy in these patients. We conducted a study to compare 3 ablation strategies in patients with persistent AF. Subjects were randomized as follows: arm 1, PVI + ablation of non-PV triggers identified using a stimulation protocol (standard approach); arm 2, standard approach + empirical ablation at common non-PV AF trigger sites (mitral annulus, fossa ovalis, eustachian ridge, crista terminalis, and superior vena cava); or arm 3, standard approach + ablation of left atrial complex fractionated electrogram sites. Patients were seen at 6 weeks, 6 months, and 1 year; transtelephonic monitoring was performed at each visit. Antiarrhythmic drugs were discontinued at 3 to 6 months. The primary study end point was freedom from atrial arrhythmias off antiarrhythmic drugs at 1 year after a single-ablation procedure. A total of 156 patients (aged 59±9 years; 136 males; AF duration, 47±50 months) participated (arm 1, 55 patients; arm 2, 50 patients; arm 3, 51 patients). Procedural outcomes (procedure, fluoroscopy, and PVI times) were comparable between the 3 arms. More lesions were required to target non-PV trigger sites than a complex fractionated electrogram (33±9 versus 22±9; P<0.001). The primary end point was achieved in 71 patients and was worse in arm 3 (29%) compared with arm 1 (49%; P=0.04) and arm 2 (58%; P=0.004). These data suggest that additional substrate modification beyond PVI does not improve single-procedure efficacy in patients with persistent AF. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00379301.

Effectiveness of virtual reality using Wii gaming technology in stroke rehabilitation: a pilot randomized clinical trial and proof of principle.

PubMed

Saposnik, Gustavo; Teasell, Robert; Mamdani, Muhammad; Hall, Judith; McIlroy, William; Cheung, Donna; Thorpe, Kevin E; Cohen, Leonardo G; Bayley, Mark

2010-07-01

Hemiparesis resulting in functional limitation of an upper extremity is common among stroke survivors. Although existing evidence suggests that increasing intensity of stroke rehabilitation therapy results in better motor recovery, limited evidence is available on the efficacy of virtual reality for stroke rehabilitation. In this pilot, randomized, single-blinded clinical trial with 2 parallel groups involving stroke patients within 2 months, we compared the feasibility, safety, and efficacy of virtual reality using the Nintendo Wii gaming system (VRWii) versus recreational therapy (playing cards, bingo, or "Jenga") among those receiving standard rehabilitation to evaluate arm motor improvement. The primary feasibility outcome was the total time receiving the intervention. The primary safety outcome was the proportion of patients experiencing intervention-related adverse events during the study period. Efficacy, a secondary outcome measure, was evaluated with the Wolf Motor Function Test, Box and Block Test, and Stroke Impact Scale at 4 weeks after intervention. Overall, 22 of 110 (20%) of screened patients were randomized. The mean age (range) was 61.3 (41 to 83) years. Two participants dropped out after a training session. The interventions were successfully delivered in 9 of 10 participants in the VRWii and 8 of 10 in the recreational therapy arm. The mean total session time was 388 minutes in the recreational therapy group compared with 364 minutes in the VRWii group (P=0.75). There were no serious adverse events in any group. Relative to the recreational therapy group, participants in the VRWii arm had a significant improvement in mean motor function of 7 seconds (Wolf Motor Function Test, 7.4 seconds; 95% CI, -14.5, -0.2) after adjustment for age, baseline functional status (Wolf Motor Function Test), and stroke severity. VRWii gaming technology represents a safe, feasible, and potentially effective alternative to facilitate rehabilitation therapy and promote motor recovery after stroke.

Medication coaching program for patients with minor stroke or TIA: a pilot study.

PubMed

Sides, Elizabeth G; Zimmer, Louise O; Wilson, Leslie; Pan, Wenqin; Olson, Daiwai M; Peterson, Eric D; Bushnell, Cheryl

2012-07-25

Patients who are hospitalized with a first or recurrent stroke often are discharged with new medications or adjustment to the doses of pre-admission medications, which can be confusing and pose safety issues if misunderstood. The purpose of this pilot study was to assess the feasibility of medication coaching via telephone after discharge in patients with stroke. Two-arm pilot study of a medication coaching program with 30 patients (20 intervention, 10 control). Consecutive patients admitted with stroke or TIA with at least 2 medications changed between admission and discharge were included. The medication coach contacted intervention arm patients post-discharge via phone call to discuss risk factors, review medications and triage patients' questions to a stroke nurse and/or pharmacist. Intervention and control participants were contacted at 3 months for outcomes. The main outcomes were feasibility (appropriateness of script, ability to reach participants, and provide requested information) and participant evaluation of medication coaching. The median lengths of the coaching and follow-up calls with requested answers to these questions were 27 minutes and 12 minutes, respectively, and participant evaluations of the coaching were positive. The intervention participants were more likely to have seen their primary care provider than were control participants by 3 months post discharge. This medication coaching study executed early after discharge demonstrated feasibility of coaching and educating stroke patients with a trained coach. Results from our small pilot showed a possible trend towards improved appointment-keeping with primary care providers in those who received coaching.

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

DTIC Science & Technology

2016-08-30

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

Mobile phone text messaging intervention to improve alertness and reduce sleepiness and fatigue during shiftwork among emergency medicine clinicians: study protocol for the SleepTrackTXT pilot randomized controlled trial.

PubMed

Patterson, Paul Daniel; Moore, Charity G; Weaver, Matthew D; Buysse, Daniel J; Suffoletto, Brian P; Callaway, Clifton W; Yealy, Donald M

2014-06-21

Mental and physical fatigue while at work is common among emergency medical services (EMS) shift workers. Extended shifts (for example 24 hours) and excessive amounts of overtime work increase the likelihood of negative safety outcomes and pose a challenge for EMS fatigue-risk management. Text message-based interventions are a potentially high-impact, low-cost platform for sleep and fatigue assessment and distributing information to workers at risk of negative safety outcomes related to sleep behaviors and fatigue. We will conduct a pilot randomized trial with a convenience sample of adult EMS workers recruited from across the United States using a single study website. Participants will be allocated to one of two possible arms for a 90-day study period. The intervention arm will involve text message assessments of sleepiness, fatigue, and difficulty with concentration at the beginning, during, and end of scheduled shifts. Intervention subjects reporting high levels of sleepiness or fatigue will receive one of four randomly selected intervention messages promoting behavior change during shiftwork. Control subjects will receive assessment only text messages. We aim to determine the performance characteristics of a text messaging tool for the delivery of a sleep and fatigue intervention. We seek to determine if a text messaging program with tailored intervention messages is effective at reducing perceived sleepiness and/or fatigue among emergency medicine clinician shift workers. Additional aims include testing whether a theory-based behavioral intervention, delivered by text message, changes 'alertness behaviors'. The SleepTrackTXT pilot trial could provide evidence of compliance and effectiveness that would support rapid widespread expansion in one of two forms: 1) a stand-alone program in the form of a tailored/individualized sleep monitoring and fatigue reduction support service for EMS workers; or 2) an add-on to a multi-component fatigue risk management program led and maintained by employers or by safety and risk management services. Clinicaltrials.gov NCT02063737, Registered on 10 January 2014.

Mobile phone text messaging intervention to improve alertness and reduce sleepiness and fatigue during shiftwork among emergency medicine clinicians: study protocol for the SleepTrackTXT pilot randomized controlled trial

PubMed Central

2014-01-01

Background Mental and physical fatigue while at work is common among emergency medical services (EMS) shift workers. Extended shifts (for example 24 hours) and excessive amounts of overtime work increase the likelihood of negative safety outcomes and pose a challenge for EMS fatigue-risk management. Text message-based interventions are a potentially high-impact, low-cost platform for sleep and fatigue assessment and distributing information to workers at risk of negative safety outcomes related to sleep behaviors and fatigue. Methods/Design We will conduct a pilot randomized trial with a convenience sample of adult EMS workers recruited from across the United States using a single study website. Participants will be allocated to one of two possible arms for a 90-day study period. The intervention arm will involve text message assessments of sleepiness, fatigue, and difficulty with concentration at the beginning, during, and end of scheduled shifts. Intervention subjects reporting high levels of sleepiness or fatigue will receive one of four randomly selected intervention messages promoting behavior change during shiftwork. Control subjects will receive assessment only text messages. We aim to determine the performance characteristics of a text messaging tool for the delivery of a sleep and fatigue intervention. We seek to determine if a text messaging program with tailored intervention messages is effective at reducing perceived sleepiness and/or fatigue among emergency medicine clinician shift workers. Additional aims include testing whether a theory-based behavioral intervention, delivered by text message, changes ‘alertness behaviors’. Discussion The SleepTrackTXT pilot trial could provide evidence of compliance and effectiveness that would support rapid widespread expansion in one of two forms: 1) a stand-alone program in the form of a tailored/individualized sleep monitoring and fatigue reduction support service for EMS workers; or 2) an add-on to a multi-component fatigue risk management program led and maintained by employers or by safety and risk management services. Trial Registration Clinicaltrials.gov NCT02063737, Registered on 10 January 2014 PMID:24952387

The Effect of a Novel form of Extended-Release Gabapentin on Pain and Sleep in Fibromyalgia Subjects: An Open-Label Pilot Study.

PubMed

North, James M; Hong, Kyung-Soo J; Rauck, Richard L

2016-07-01

We assessed the efficacy and safety of extended-release gabapentin in a 15-week, open-label, single-arm, single-center study in patients with fibromyalgia (FM). Subjects with documented diagnosis of FM were allowed to participate in the study. We opened enrollment to those who have tried and failed gabapentinoids such as gabapentin or pregabalin due to side effects. Subjects with autoimmune conditions, and or taking opioids for management of their FM pain, were excluded from the study. Subjects were given an extended-release gabapentin starter pack and treated for total of 12 weeks. The primary study endpoint of pain relief was measured using Numeric Pain Rating System (NPRS) scores, and secondary study endpoints were measured with Fibromyalgia Impact Questionnaire (FIQ), Patient's Global Impression of Change (PGIC), and Medical Outcome Sleep questionnaires (MOS). A total of 34 subjects were enrolled and 29 subjects completed the starter pack (85%). Patients reported significant pain relief on NPRS by end of 4 weeks (P < 0.0001) on NPRS. Subjects also reported similar magnitude of improvements in FM and its impact on daily life by end of 4 weeks on FIQ (P < 0.0001). Survey of MOS showed our subjects reporting improved sleep quantity (on average, 1.2 hours over baseline) with gradual and statistically significant improvement in quality. Improvements in primary and secondary measurements were reflected in PGIC, with significant improvement in patient's impression of FM by week 8. Small sample size, geographical bias, relatively short duration of treatment, and single-arm study without control group. Extended-release gabapentin relieved FM pain symptoms and improved quality-of-life for the FM subjects studied. Subjects reported improvements in both quantity and quality of sleep. © 2015 World Institute of Pain.

Is home-based palliative care cost-effective? An economic evaluation of the Palliative Care Extended Packages at Home (PEACH) pilot.

PubMed

McCaffrey, Nikki; Agar, Meera; Harlum, Janeane; Karnon, Jonathon; Currow, David; Eckermann, Simon

2013-12-01

The aim of this study was to evaluate the cost-effectiveness of a home-based palliative care model relative to usual care in expediting discharge or enabling patients to remain at home. Economic evaluation of a pilot randomised controlled trial with 28 days follow-up. Mean costs and effectiveness were calculated for the Palliative Care Extended Packages at Home (PEACH) and usual care arms including: days at home; place of death; PEACH intervention costs; specialist palliative care service use; acute hospital and palliative care unit inpatient stays; and outpatient visits. PEACH mean intervention costs per patient ($3489) were largely offset by lower mean inpatient care costs ($2450) and in this arm, participants were at home for one additional day on average. Consequently, PEACH is cost-effective relative to usual care when the threshold value for one extra day at home exceeds $1068, or $2547 if only within-study days of hospital admission are costed. All estimates are high uncertainty. The results of this small pilot study point to the potential of PEACH as a cost-effective end-of-life care model relative to usual care. Findings support the feasibility of conducting a definitive, fully powered study with longer follow-up and comprehensive economic evaluation.

Hyperthermia and Radiation Therapy in Locoregional Recurrent Breast Cancers: A Systematic Review and Meta-analysis

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

Datta, Niloy R., E-mail: niloyranjan.datta@ksa.ch; Puric, Emsad; Klingbiel, Dirk

Purpose: To conduct a systematic review and meta-analysis to evaluate the outcome of hyperthermia (HT) and radiation therapy (RT) in locally recurrent breast cancers (LRBCs). Methods and Materials: A total of 708 abstracts were screened from 8 databases according to the PRISMA guidelines. Single-arm and 2-arm studies, treating LRBCs with HT and RT but without surgery (for local recurrence) or concurrent chemotherapy were considered. The evaluated endpoint was complete response (CR). Results: Thirty-one full text articles, pertaining to 34 studies, were shortlisted for the meta-analysis. Eight were 2-arm (randomized, n=5; nonrandomized, n=3), whereas 26 were single-arm studies. In all, 627more » patients were enrolled in 2-arm and 1483 in single-arm studies. Patients were treated with a median of 7 HT sessions, and an average temperature of 42.5°C was attained. Mean RT dose was 38.2 Gy (range, 26-60 Gy). Hyperthermia was most frequently applied after RT. In the 2-arm studies, a CR of 60.2% was achieved with RT + HT versus 38.1% with RT alone (odds ratio 2.64, 95% confidence interval [CI] 1.66-4.18, P<.0001). Risk ratio and risk difference were 1.57 (95% CI 1.25-1.96, P<.0001) and 0.22 (95% CI 0.11-0.33, P<.0001), respectively. In 26 single-arm studies, RT + HT attained a CR of 63.4% (event rate 0.62, 95% CI 0.57-0.66). Moreover, 779 patients had been previously irradiated (696 from single-arm and 83 from 2-arm studies). A CR of 66.6% (event rate 0.64, 95% CI 0.58-0.70) was achieved with HT and reirradiation (mean ± SD dose: 36.7 ± 7.7 Gy). Mean acute and late grade 3/4 toxicities with RT + HT were 14.4% and 5.2%, respectively. Conclusions: Thermoradiation therapy enhances the likelihood of CR rates in LRBCs over RT alone by 22% with minimal acute and late morbidities. For even those previously irradiated, reirradiation with HT provides locoregional control in two-thirds of the patients. Thermoradiation therapy could therefore be considered as an effective and safe palliative treatment option for LRBCs.« less

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

NASA Technical Reports Server (NTRS)

Weislogel, S.

1983-01-01

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

[The assessment of functional capacity in workers with the thoracic outlet syndrome. A pilot study].

PubMed

Capodaglio, P; Gibellini, R; Grilli, C; Bazzini, G

1997-01-01

Occupational specialists are well aware of the lack of objective measurements for the diagnosis and the functional evaluation of workers affected by thoracic outlet syndrome (TOS). Subjects affected by TOS refer pain, sensation of fatigue in the arm frequently aggravated by overhead work. A "stick-up" position tends to close the costoclavicular space and tense the neck and shoulder muscles to bring into play the abnormal compression mechanism that may affect the brachial plexus nerves and the subclavian vessels. In a previous study, we demonstrated the reliability of an isokinetic hand grip endurance test. In this pilot study we asked 7 industrial workers affected by TOS to perform a 30-second isokinetic endurance test for hand gripping with a Lido WorkSET dynamometer. Tests were performed in two positions (resting and "stick-up" position) before and after a 3-week intensive rehabilitation program. In addition, the subjects performed daily aerobic exercise with an arm crank ergometer. Objective indexes of posttreatment improvement were found. Subjects were able to generate higher grip forces during the isokinetic hand grip endurance test and to sustain higher mechanical workload with the arm ergometer at the same intensity level for longer duration after completion of the rehabilitation program.

Feasibility, safety and efficacy of transcutaneous vagus nerve stimulation in chronic tinnitus: an open pilot study.

PubMed

Kreuzer, Peter M; Landgrebe, Michael; Resch, Markus; Husser, Oliver; Schecklmann, Martin; Geisreiter, Florian; Poeppl, Timm B; Prasser, Sarah J; Hajak, Goeran; Rupprecht, Rainer; Langguth, Berthold

2014-01-01

Vagus nerve stimulation represents an established treatment strategy for epilepsy and affective disorders. Recently, positive effects were also shown in animals and humans with tinnitus. Here we report the results of an open pilot study exploring feasibility, safety and efficacy of tVNS in the treatment of chronic tinnitus. Fifty patients with chronic tinnitus underwent tVNS in an open single-armed pilot study which was conducted in two phases applying two different stimulating devices (Cerbomed CM02 and NEMOS). Clinical assessment was based on Tinnitus Questionnaire (TQ), Tinnitus Handicap Inventory (THI), Beck Depression Inventory (BDI), WHO Quality of Life, and various numeric rating scales. Primary outcome was defined as change in TQ (baseline vs. final visit in week 24). The study has been registered with clinicaltrials.gov (NCT01176734). Primary analysis indicated mean TQ reductions of 3.7 points (phase 1) and 2.8 points (phase 2) significant for the first study phase. Secondary analyses indicated a significant BDI reduction for phase 1 (uncorrected for multiple testing), but no further systematic or significant effects. Adverse events included twitching and pressure at electrode placement site. The occurrence of one hospitalization because of palpations and the development of a left bundle branch block were considered as unrelated to the intervention. Cognitive testing revealed no significant changes. Our data demonstrate the feasibility of tVNS over a period of 6 months. There was no clinically relevant improvement of tinnitus complaints. Our data suggest tVNS to be considered safe in patients without a history of cardiac disease. Copyright © 2014 Elsevier Inc. All rights reserved.

Feasibility, acceptability and preliminary psychological benefits of mindfulness meditation training in a sample of men diagnosed with prostate cancer on active surveillance: results from a randomized controlled pilot trial.

PubMed

Victorson, David; Hankin, Vered; Burns, James; Weiland, Rebecca; Maletich, Carly; Sufrin, Nathaniel; Schuette, Stephanie; Gutierrez, Bruriah; Brendler, Charles

2017-08-01

In a pilot randomized controlled trial, examine the feasibility and preliminary efficacy of an 8-week, mindfulness training program (Mindfulness Based Stress Reduction) in a sample of men on active surveillance on important psychological outcomes including prostate cancer anxiety, uncertainty intolerance and posttraumatic growth. Men were randomized to either mindfulness (n = 24) or an attention control arm (n = 19) and completed self-reported measures of prostate cancer anxiety, uncertainty intolerance, global quality of life, mindfulness and posttraumatic growth at baseline, 8 weeks, 6 months and 12 months. Participants in the mindfulness arm demonstrated significant decreases in prostate cancer anxiety and uncertainty intolerance, and significant increases in mindfulness, global mental health and posttraumatic growth. Participants in the control condition also demonstrated significant increases in mindfulness over time. Longitudinal increases in posttraumatic growth were significantly larger in the mindfulness arm than they were in the control arm. While mindfulness training was found to be generally feasible and acceptable among participants who enrolled in the 8-week intervention as determined by completion rates and open-ended survey responses, the response rate between initial enrollment and the total number of men approached was lower than desired (47%). While larger sample sizes are necessary to examine the efficacy of mindfulness training on important psychological outcomes, in this pilot study posttraumatic growth was shown to significantly increase over time for men in the treatment group. Mindfulness training has the potential to help men cope more effectively with some of the stressors and uncertainties associated with active surveillance. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Preventing recurrence of endometriosis by means of long-acting progestogen therapy (PRE-EMPT): report of an internal pilot, multi-arm, randomised controlled trial incorporating flexible entry design and adaption of design based on feasibility of recruitment.

PubMed

Middleton, Lee J; Daniels, Jane P; Weckesser, Annalise; Bhattacharya, Siladitya

2017-03-11

Endometriosis is associated with the growth of endometrium in ectopic sites mainly within the pelvis. This results in inflammation and scarring, causing pain and impaired quality of life. Endometriotic lesions can be excised or ablated surgically, but the risk of recurrence is high. A Heath Technology Assessment commissioning call in 2011 sought applications for trials aimed at evaluating long-term effectiveness of postoperative, long-acting, reversible contraceptives (LARCs) in preventing recurrence of endometriosis. A survey of gynaecologists indicated that there was no consensus about which LARC (Levonorgestrel Intrauterine System (LNG-IUS) or depot medroxyprogesterone acetate injection (DMPA)) or comparator (combined oral contraceptive pill (COCP) or no treatment) should be evaluated. Hence, we designed a 'flexible-entry' internal pilot to assess whether a four-arm trial was feasible including a possible design adaption based on pilot findings. In this pilot, women could be randomised to two, three or four treatment options provided that one was a LARC and one was a non-LARC. An assessment of feasibility based on recruitment to these options and a revised substantive trial design was considered by an independent oversight committee. The study ran for 1 year from April 2014 and 77 women were randomised. Only 5 (6%) women accepted randomisation to all groups, with 63 (82%) having a LARC preference and 55 (71%) a non-LARC preference. Four-way and three-way designs were ruled out with a two-way LARC versus COCP design, stratified by prerandomisation choice of LARC and optional subrandomisation to LNG-IUS versus DMPA considered a feasible substantive study. Multi-arm studies are potentially efficient as they can answer multiple questions simultaneously but are difficult to recruit to if there are strong patient or clinician preferences. A flexible approach to randomisation in a pilot phase can be used to assess feasibility of such studies and modify a trial design based on chosen recruitment options, but trialists should consider carefully any practical arrangements should groups need to be dropped during a study. International Standard Randomised Controlled Trial Number, ISRCTN97865475 . Registered on 20 March 2014.

Immediate effect of three different electroacupuncture protocols on fasting blood glucose in obese patients: a pilot study.

PubMed

Belivani, Maria; Lundeberg, Thomas; Cummings, Mike; Dimitroula, Charikleia; Belivani, Nicole; Vasilakos, Dimitris; Hatzitolios, Apostolos

2015-04-01

Obesity is an increasing global health problem, and current methods of management are limited. Preliminary research data suggest that acupuncture may have an influence on metabolic parameters related to obesity. To determine the electroacupuncture (EA) protocol to be used in a future clinical trial examining the effect of acupuncture on metabolic parameters related to obesity and to examine whether a single EA treatment can change fasting blood glucose in obese subjects. 16 obese women aged 30-52 years with body mass index >30 kg/m(2) were assigned consecutively into three groups and their fasting blood glucose was measured before and after administering a single session, lasting 30 min, of one of three EA treatment protocols. The Dorsal group received EA to dorsal segmental acupuncture points BL18-23 bilaterally (corresponding to the segmental levels innervating the pancreas); the Ear group received EA to ear points in the cavum conchae; and the Limb group received EA to points in the arms and legs (LI10-LI11, ST36-Zongping). After a single session of EA there was a statistically significant decrease in fasting blood glucose in the Dorsal and Limb groups, but there was no change and even a trend towards an increase in the glucose level in the Ear group. The findings of this small pilot study suggest that EA to either dorsal segmental points corresponding to the pancreas or to muscle points in all four limbs may exert a beneficial effect on glucose metabolism in obese women. 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.

Addressing sexual dysfunction after risk-reducing salpingo-oophorectomy: effects of a brief, psychosexual intervention.

PubMed

Bober, Sharon L; Recklitis, Christopher J; Bakan, Jennifer; Garber, Judy E; Patenaude, Andrea F

2015-01-01

Women at high risk for ovarian cancer due to BRCA1 or BRCA2 mutation or family history are recommended to undergo risk-reducing salpingo-oophorectomy (RRSO) after age 35 or completion of childbearing. This potentially life-saving surgery leads to premature menopause, frequently resulting in distressing and unaddressed sexual dysfunction. To pilot a novel sexual health intervention for women with BRCA1/2 mutations who previously underwent RRSO a using a single-arm trial. Feasibility and primary outcomes including sexual dysfunction and psychological distress were assessed. This single-arm trial included a one-time, half-day educational session comprised of targeted sexual health education, body awareness and relaxation training, and mindfulness-based cognitive therapy strategies, followed by two sessions of tailored telephone counseling. Assessments were completed at baseline and 2 months postintervention. Study end points include feasibility and effectiveness as reported by the participant. Thirty-seven women completed baseline and postintervention assessments. At baseline, participants had a mean age of 44.4 (standard deviation [SD] = 3.9) years and mean duration of 3.8 (SD = 2.7) years since RRSO. Overall sexual functioning (P = 0.018), as well as desire (P = 0.003), arousal (P = 0.003), satisfaction (P = 0.028), and pain (P = 0.018), improved significantly. There were significant reductions in somatization (P = 0.029) and anxiety scores (P < 0.001), and, overall, for the Global Severity Index (P < 0.001) of the Brief Symptom Inventory. Sexual self-efficacy and sexual knowledge also improved significantly from baseline to postintervention (both P < 0.001). Women were highly satisfied with the intervention content and reported utilizing new skills to manage sexual dysfunction. This intervention integrates elements of cognitive behavioral therapy with sexual health education to address a much-neglected problem after RRSO. Results from this promising single-arm study provide preliminary data to move toward conducting a randomized, controlled trial. © 2014 International Society for Sexual Medicine.

A cluster randomized pilot trial of a tailored worksite smoking cessation intervention targeting Hispanic/Latino construction workers: Intervention development and research design.

PubMed

Asfar, Taghrid; Caban-Martinez, Alberto J; McClure, Laura A; Ruano-Herreria, Estefania C; Sierra, Danielle; Gilford Clark, G; Samano, Daniel; Dietz, Noella A; Ward, Kenneth D; Arheart, Kristopher L; Lee, David J

2018-04-01

Construction workers have the highest smoking rate among all occupations (39%). Hispanic/Latino workers constitute a large and increasing group in the US construction industry (over 2.6 million; 23% of all workers). These minority workers have lower cessation rates compared to other groups due to their limited access to cessation services, and lack of smoking cessation interventions adapted to their culture and work/life circumstances. Formative research was conducted to create an intervention targeting Hispanic/Latino construction workers. This paper describes the intervention development and the design, methods, and data analysis plans for an ongoing cluster pilot two-arm randomized controlled trial comparing an Enhanced Care worksite cessation program to Standard Care. Fourteen construction sites will be randomized to either Enhanced Care or Standard Care and 126 participants (63/arm) will be recruited. In both arms, recruitment and intervention delivery occur around "food trucks" that regularly visit the construction sites. Participants at Enhanced Care sites will receive the developed intervention consisting of a single face-to-face group counseling session, 2 phone calls, and a fax referral to Florida tobacco quitline (QL). Participants at Standard Care sites will receive a fax referral to the QL. Both groups will receive eight weeks of nicotine replacement treatment and two follow-up assessments at three and six months. Feasibility outcomes are estimated recruitment yield, barriers to delivering the intervention onsite, and rates of adherence/compliance to the intervention, follow-ups, and QL enrollment. Efficacy outcomes are point-prevalence and prolonged abstinence rates at six month follow-up confirmed by saliva cotinine <15 ng/ml. Copyright © 2018. Published by Elsevier Inc.

A pilot study of gene expression analysis in workers with hand-arm vibration syndrome.

PubMed

Maeda, Setsuo; Yu, Xiaozhong; Wang, Rui-Sheng; Sakakibara, Hisataka

2008-04-01

The purpose of this pilot study was to examine differences in gene expressions by cDNA microarray analysis of hand-arm vibration syndrome (HAVS) patients. Vein blood samples were collected and total RNA was extracted. All blood samples were obtained in the morning in one visit after a standard light breakfast. We performed microarray analysis with the labeled cDNA prepared by reverse transcription from RNA samples, using the Human CHIP version 1 (DNA Chip Research Inc, Yokohama, Japan). There are 2,976 genes on the chip, and these genes were selected from a cDNA library prepared with human peripheral white blood cells (WBC). Different gene levels between the HAVS patients and controls, and between groups of HAVS with different levels of symptoms, were indicated by the randomized variance model. The most up-regulated genes were analyzed for their possible functions and association with the occurrence of HAVS. From the results of this pilot study, although the results were obtained a limited number of subjects, it would appear that cDNA microarray analysis of HAVS patients has potential as a new objective method of HAVS diagnosis. Further research is needed to examine the gene expression with increased numbers of patients at different stages of HAVS.

Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial.

PubMed

Platt, Jennica; Baxter, Nancy; Jones, Jennifer; Metcalfe, Kelly; Causarano, Natalie; Hofer, Stefan O P; O'Neill, Anne; Cheng, Terry; Starenkyj, Elizabeth; Zhong, Toni

2013-07-06

The Pre-Consultation Educational Group INTERVENTION pilot study seeks to assess the feasibility and inform the optimal design for a definitive randomized controlled trial that aims to improve the quality of decision-making in postmastectomy breast reconstruction patients. This is a mixed-methods pilot feasibility randomized controlled trial that will follow a single-center, 1:1 allocation, two-arm parallel group superiority design. The University Health Network, a tertiary care cancer center in Toronto, Canada. Adult women referred to one of three plastic and reconstructive surgeons for delayed breast reconstruction or prophylactic mastectomy with immediate breast reconstruction. We designed a multi-disciplinary educational group workshop that incorporates the key components of shared decision-making, decision-support, and psychosocial support for cancer survivors prior to the initial surgical consult. The intervention consists of didactic lectures by a plastic surgeon and nurse specialist on breast reconstruction choices, pre- and postoperative care; a value-clarification exercise led by a social worker; and discussions with a breast reconstruction patient. Usual care includes access to an informational booklet, website, and patient volunteer if desired. Expected pilot outcomes include feasibility, recruitment, and retention targets. Acceptability of intervention and full trial outcomes will be established through qualitative interviews. Trial outcomes will include decision-quality measures, patient-reported outcomes, and service outcomes, and the treatment effect estimate and variability will be used to inform the sample size calculation for a full trial. Our pilot study seeks to identify the (1) feasibility, acceptability, and design of a definitive RCT and (2) the optimal content and delivery of our proposed educational group intervention. Thirty patients have been recruited to date (8 April 2013), of whom 15 have been randomized to one of three decision support workshops. The trial will close as planned in May 2013. NCT01857882.

Assessing the feasibility of the Effectiveness of Discontinuing Bisphosphonates trial: a pilot study.

PubMed

Wright, N C; Foster, P J; Mudano, A S; Melnick, J A; Lewiecki, M E; Shergy, W J; Curtis, J R; Cutter, G R; Danila, M I; Kilgore, M L; Lewis, E C; Morgan, S L; Redden, D T; Warriner, A H; Saag, K G

2017-08-01

The Effectiveness of Discontinuing Bisphosphonates (EDGE) study is a planned pragmatic clinical trial to guide "drug holiday" clinical decision making. This pilot study assessed work flow and feasibility of such a study. While participant recruitment and treatment adherence were suboptimal, administrative procedures were generally feasible and minimally disrupted clinic flow. The comparative effectiveness of continuing or discontinuing long-term alendronate (ALN) on fractures is unknown. A large pragmatic ALN discontinuation study has potential to answer this question. We conducted a 6-month pilot study of the planned the EDGE study among current long-term ALN users (women aged ≥65 with ≥3 years of ALN use) to determine study work flow and feasibility including evaluating the administrative aspects of trial conduct (e.g., time to contract, institutional review board (IRB) approval), assessing rates of site and participant recruitment, and evaluating post-randomization outcomes, including adherence, bisphosphonate-associated adverse events, and participant and site satisfaction. We assessed outcomes 1 and 6 months after randomization. Nine sites participated, including seven community-based medical practices and two academic medical centers. On average (SD), contract execution took 3.4 (2.3) months and IRB approval took 13.9 (4.1) days. Sites recruited 27 participants (13 to continue ALN and 14 to discontinue ALN). Over follow-up, 22% of participants did not adhere to their randomization assignment: 30.8% in the continuation arm and 14.3% in the discontinuation arm. No fractures or adverse events were reported. Sites reported no issues regarding work flow, and participants were highly satisfied with the study. Administrative procedures of the EDGE study were generally feasible, with minimal disruption to clinic flow. In this convenience sample, participant recruitment was suboptimal across most practice sites. Accounting for low treatment arm adherence, a comprehensive recruitment approach will be needed to effectively achieve the scientific goals of the EDGE study.

A pilot study of durvalumab and tremelimumab and immunogenomic dynamics in metastatic breast cancer

PubMed Central

Santa-Maria, Cesar August; Kato, Taigo; Park, Jae-Hyun; Kiyotani, Kazuma; Rademaker, Alfred; Shah, Ami N.; Gross, Leeaht; Blanco, Luis Z.; Jain, Sarika; Flaum, Lisa; Tellez, Claudia; Stein, Regina; Uthe, Regina; Gradishar, William J.; Cristofanilli, Massimo; Nakamura, Yusuke; Giles, Francis J.

2018-01-01

Immune checkpoint inhibitors produce modest responses in metastatic breast cancer, however, combination approaches may improve responses. A single arm pilot study was designed to determine the overall response rate (ORR) of durvalumab and tremelimumab, and evaluate immunogenomic dynamics in metastatic endocrine receptor (ER) positive or triple negative breast cancer (TNBC). Simon two-stage design indicated at least four responses from the first 18 patients were needed to proceed with the second stage. T-cell receptor (TCR) sequencing and immune-gene expression profiling were conducted at baseline and two months, whole exome sequencing was conducted at baseline. Eighteen evaluable patients were accrued (11 ER-positive; seven TNBC). Only three patients had a response (ORR = 17%), thus the study did not proceed to the second stage. Responses were only observed in patients with TNBC (ORR = 43%). Responders versus non-responders had upregulation of CD8, granzyme A, and perforin 1 gene expression, and higher mutational and neoantigen burden. Patients with TNBC had an oligoclonal shift of the most abundant TCR-beta clonotypes compared to those with ER-positive disease, p = 0.004. We conclude responses are low in unselected metastatic breast cancer, however, higher rates of clinical benefit were observed in TNBC. Immunogenomic dynamics may help identify phenotypes most likely to respond to immunotherapy. PMID:29721177

Evaluation of inertial devices for the control of large, flexible, space-based telerobotic arms

NASA Technical Reports Server (NTRS)

Montgomery, Raymond C.; Kenny, Sean P.; Ghosh, Dave; Shenhar, Joram

1993-01-01

Inertial devices, including sensors and actuators, offer the potential of improving the tracking of telerobotic commands for space-based robots by smoothing payload motions and suppressing vibrations. In this paper, inertial actuators (specifically, torque-wheels and reaction-masses) are studied for that potential application. Batch simulation studies are presented which show that torque-wheels can reduce the overshoot in abrupt stop commands by 82 percent for a two-link arm. For man-in-the-loop evaluation, a real-time simulator has been developed which samples a hand-controller, solves the nonlinear equations of motion, and graphically displays the resulting motion on a computer workstation. Currently, two manipulator models, a two-link, rigid arm and a single-link, flexible arm, have been studied. Results are presented which show that, for a single-link arm, a reaction-mass/torque-wheel combination at the payload end can yield a settling time of 3 s for disturbances in the first flexible mode as opposed to 10 s using only a hub motor. A hardware apparatus, which consists of a single-link, highly flexible arm with a hub motor and a torque-wheel, has been assembled to evaluate the concept and is described herein.

Evaluation of inertial devices for the control of large, flexible, space-based telerobotic arms

NASA Astrophysics Data System (ADS)

Montgomery, Raymond C.; Kenny, Sean P.; Ghosh, Dave; Shenhar, Joram

1993-02-01

Inertial devices, including sensors and actuators, offer the potential of improving the tracking of telerobotic commands for space-based robots by smoothing payload motions and suppressing vibrations. In this paper, inertial actuators (specifically, torque-wheels and reaction-masses) are studied for that potential application. Batch simulation studies are presented which show that torque-wheels can reduce the overshoot in abrupt stop commands by 82 percent for a two-link arm. For man-in-the-loop evaluation, a real-time simulator has been developed which samples a hand-controller, solves the nonlinear equations of motion, and graphically displays the resulting motion on a computer workstation. Currently, two manipulator models, a two-link, rigid arm and a single-link, flexible arm, have been studied. Results are presented which show that, for a single-link arm, a reaction-mass/torque-wheel combination at the payload end can yield a settling time of 3 s for disturbances in the first flexible mode as opposed to 10 s using only a hub motor. A hardware apparatus, which consists of a single-link, highly flexible arm with a hub motor and a torque-wheel, has been assembled to evaluate the concept and is described herein.

The effects of yoga on shoulder and spinal actions for women with breast cancer-related lymphoedema of the arm: A randomised controlled pilot study.

PubMed

Loudon, Annette; Barnett, Tony; Piller, Neil; Immink, Maarten A; Visentin, Denis; Williams, Andrew D

2016-09-02

We aimed to evaluate the effect of an 8-week yoga intervention on the shoulder and spinal actions of women with breast cancer-related arm lymphoedema. A randomised controlled pilot trial. The intervention group (n = 12) completed eight weeks of daily yoga sessions while the control group (n = 11) continued with best current care including information on compression sleeves, skin care, risks of temperature variations and recommended safe use of affected arm. Lumbo-pelvic posture, range of motion (ROM) in the shoulder and spine, and strength in shoulder and pectoral major and minor, and serratus anterior were taken at baseline, week 8 and after a 4-week follow-up. Outcome assessors were blinded to allocation. At week eight the intervention group had an improvement in lumbo-pelvic posture, as indicated by a reduction in pelvic obliquity compared to the control group (mean difference = -8.39°, 95 % CI: -15.64 to -1.13°, p = 0.023). A secondary finding was that strength in shoulder abduction significantly increased following the yoga intervention in both the affected (9.5 kg; CI: 0.34 to 18.66, p = 0.042) and non-affected arm (11.58 kg; CI: 0.25 to 22.91; p = 0.045). There were no significant between group changes in any ROM measures as a result of the yoga intervention. This pilot study demonstrates that participation in yoga may provide benefits for posture and strength in women with Breast Cancer Related Lymphoedema. The improvements may be attributed to the focus of yoga on overall postural and functional movement patterns. Further trials with longer intervention that follow this methodology are warranted. The Australian New Zealand Clinical Trials Registry ACTRN12611000202965 .

Pilot Study to Show the Feasibility of a Multicenter Trial of Home-based Assessment of People Over 75 Years Old

PubMed Central

Sano, Mary; Egelko, Susan; Ferris, Steven; Kaye, Jeffrey; Hayes, Tamara L.; Mundt, James C.; Donohue, Michael; Walter, Sarah; Sun, Shelly; Sauceda-Cerda, Luis

2012-01-01

This report describes a pilot study to evaluate feasibility of new home-based assessment technologies applicable to clinical trials for prevention of cognitive loss and Alzheimer disease. Methods Community-dwelling nondemented individuals ≥ 75 years old were recruited and randomized to 1 of 3 assessment methodologies: (1) mail-in questionnaire/live telephone interviews (MIP); (2) automated telephone with interactive voice recognition (IVR); and (3) internet-based computer Kiosk (KIO). Brief versions of cognitive and noncognitive outcomes were adapted to the different methodologies and administered at baseline and 1-month. An Efficiency measure, consisting of direct staff-to-participant time required to complete assessments, was also compared across arms. Results Forty-eight out of 60 screened participants were randomized. The dropout rate across arms from randomization through 1-month was different: 33% for KIO, 25% for IVR, and 0% for MIP (Fisher Exact Test P = 0.04). Nearly all participants who completed baseline also completed 1-month assessment (38 out of 39). The 1-way ANOVA across arms for total staff-to-participant direct contact time (ie, training, baseline, and 1-month) was significant: F (2,33) = 4.588; P = 0.017, with lowest overall direct time in minutes for IVR (Mn = 44.4; SD = 21.5), followed by MIP (Mn = 74.9; SD = 29.9), followed by KIO (Mn = 129.4; SD = 117.0). Conclusions In this sample of older individuals, a higher dropout rate occurred in those assigned to the high-technology assessment techniques; however, once participants had completed baseline in all 3 arms, they continued participation through 1 month. High-technology home-based assessment methods, which do not require live testers, began to emerge as more time-efficient over the brief time of this pilot, despite initial time-intensive participant training. PMID:20592583

Throwing enhances humeral shaft cortical bone properties in pre-pubertal baseball players: a 12-month longitudinal pilot study.

PubMed

Weatherholt, Alyssa M; Warden, Stuart J

2018-06-01

To explore throwing athletes as a prospective, within-subject controlled model for studying the response of the skeleton to exercise. Male pre-pubertal throwing athletes (n=12; age=10.3±0.6 yrs) had distal humerus cortical volumetric bone mineral density (Ct.vBMD), cortical bone mineral content (Ct.BMC), total area (Tt.Ar), cortical area (Ct.Ar), medullary area (Me.Ar), cortical thickness (Ct.Th) and polar moment of inertia (IP) assessed within their throwing (exercised) and nonthrowing (control) arms by peripheral quantitative computed tomography at baseline and 12 months. Throwing-to-nonthrowing arm percent differences (i.e. bilateral asymmetry) were compared over time. Over 12 months, the throwing arm gained 4.3% (95% Cl=1.1% to 7.5%), 2.9% (95% Cl=0.3% to 5.4%), 3.9% (95% Cl=0.7% to 7.0%), and 8.2% (95% Cl=2.0% to 6.8%) more Ct.BMC, Ct.Ar, Tt.Ar, and I P than the nonthrowing arm, respectively (all p<0.05). There was no significant effect of throwing on Ct.vBMD, Ct.Th and Me.Ar (all p=0.18-0.82). Throwing induced surface-specific cortical bone adaptation at the distal humeral diaphysis that contributed to a gain in estimated strength. These longitudinal pilot data support the utility of throwing athletes as a within-subject controlled model to explore factors influencing exercise-induced bone adaptation during the critical growing years.

Design and pilot validation of A-gear: a novel wearable dynamic arm support.

PubMed

Kooren, Peter N; Dunning, Alje G; Janssen, Mariska M H P; Lobo-Prat, Joan; Koopman, Bart F J M; Paalman, Micha I; de Groot, Imelda J M; Herder, Just L

2015-09-18

Persons suffering from progressive muscular weakness, like those with Duchenne muscular dystrophy (DMD), gradually lose the ability to stand, walk and to use their arms. This hinders them from performing daily activities, social participation and being independent. Wheelchairs are used to overcome the loss of walking. However, there are currently few efficient functional substitutes to support the arms. Arm supports or robotic arms can be mounted to wheelchairs to aid in arm motion, but they are quite visible (stigmatizing), and limited in their possibilities due to their fixation to the wheelchair. The users prefer inconspicuous arm supports that are comfortable to wear and easy to control. In this paper the design, characterization, and pilot validation of a passive arm support prototype, which is worn on the body, is presented. The A-gear runs along the body from the contact surface between seat and upper legs via torso and upper arm to the forearm. Freedom of motion is accomplished by mechanical joints, which are nearly aligned with the human joints. The system compensates for the arm weight, using elastic bands for static balance, in every position of the arm. As opposed to existing devices, the proposed kinematic structure allows trunk motion and requires fewer links and less joint space without compromising balancing precision. The functional prototype has been validated in three DMD patients, using 3D motion analysis. Measurements have shown increased arm performance when the subjects were wearing the prototype. Upward and forward movements were easier to perform. The arm support is easy to put on and remove. Moreover, the device felt comfortable for the subjects. However, downward movements were more difficult, and the patients would prefer the device to be even more inconspicuous. The A-gear prototype is a step towards inconspicuousness and therefore well-received dynamic arm supports for people with muscular weakness.

Effect of vertical active vibration isolation on tracking performance and on ride qualities

NASA Technical Reports Server (NTRS)

Dimasi, F. P.; Allen, R. E.; Calcaterra, P. C.

1972-01-01

An investigation to determine the effect on pilot performance and comfort of an active vibration isolation system for a commercial transport pilot seat is reported. The test setup consisted of: a hydraulic shaker which produced random vertical vibration inputs; the active vibration isolation system; the pilot seat; the pilot control wheel and column; the side-arm controller; and a two-axis compensatory tracking task. The effects of various degrees of pilot isolation on short-term (two-minute) tracking performance and comfort were determined.

Pilot study of pharmacist-assisted delivery of pharmacogenetic testing in a primary care setting.

PubMed

Haga, Susanne B; LaPointe, Nancy M Allen; Cho, Alex; Reed, Shelby D; Mills, Rachel; Moaddeb, Jivan; Ginsburg, Geoffrey S

2014-09-01

To describe the rationale and design of a pilot program to implement and evaluate pharmacogenetic (PGx) testing in a primary care setting. Several factors have impeded the uptake of PGx testing, including lack of provider knowledge and challenges with operationalizing PGx testing in a clinical practice setting. We plan to compare two strategies for the implementation of PGx testing: a pharmacist-initiated testing arm compared with a physician-initiated PGx testing arm. Providers in both groups will be required to attend an introduction to PGx seminar. Anticipated results: We anticipate that providers in the pharmacist-initiated group will be more likely to order PGx testing than providers in the physician-initiated group. Overall, we aim to generate data that will inform an effective delivery model for PGx testing and to facilitate a seamless integration of PGx testing in primary care practices.

Legislated emergency locating transmitters and emergency position indicating radio beacons

NASA Technical Reports Server (NTRS)

Wade, William R. (Inventor)

1988-01-01

An emergency locating transmitting (ELT) system is disclosed which comprises a legislated ELT modified with an interface unit and connected by a multiwire cable to a remote control monitor (RCM), typically located at the pilot position. The RCM can remotely test the ELT by disabling the legislated swept tone and allowing transmission of a single tone, turn the ELT on for legislated ELT transmission, and reset the ELT to an armed condition. The RCM also provides visual and audio indications of transmitter operating condition as well as ELT battery condition. Removing the RCM or shorting or opening the interface input connections will not affect traditional ELT operation.

Efficacy of a biobehavioral intervention for hot flashes: a randomized controlled pilot study.

PubMed

Barton, Debra L; Schroeder, Kelliann C Fee; Banerjee, Tanima; Wolf, Sherry; Keith, Timothy Z; Elkins, Gary

2017-07-01

The need for effective nonhormonal treatments for hot flash management without unwanted side effects continues. The primary aim of this pilot study was to evaluate the effect of combining a nonhormonal pharmacologic agent with a behavioral treatment for hot flash reduction. Seventy-one postmenopausal women were randomized to one of four groups: venlafaxine 75 mg + hypnosis (VH) versus venlafaxine 75 mg + sham hypnosis (VSH) versus a placebo pill + hypnosis (PH) versus placebo pill + sham hypnosis (PSH). Women recorded hot flash severity and frequency in a daily diary, in real time. The intrapatient difference in hot flash score (frequency × severity) at 8 weeks was analyzed using a General Estimating Equation model, using VSH as the referent arm, controlling for baseline hot flashes. The active arms including PH or VH were not statistically significantly different than VSH (P = 0.34, P = 0.05, respectively). Women in each active arm reported hot flash reductions of about 50%, with the PSH group reporting a 25% reduction. Women receiving the PSH reported statistically significantly smaller reductions in hot flash score than women in the referent VSH arm (P = 0.001). There were no significant negative side effects during the course of the study. Hypnosis alone reduced hot flashes equal to venlafaxine alone, but the combination of hypnosis and venlafaxine did not reduce hot flashes more than either treatment alone. More research is needed to clarify whether combining hypnosis with a different antidepressant would provide synergistic benefits.

A randomized, placebo-controlled trial of repetitive spinal magnetic stimulation in lumbosacral spondylotic pain.

PubMed

Lo, Yew L; Fook-Chong, Stephanie; Huerto, Antonio P; George, Jane M

2011-07-01

Lumbar spondylosis is a degenerative disorder of the spine, whereby pain is a prominent feature that poses therapeutic challenges even after surgical intervention. There are no randomized, placebo-controlled studies utilizing repetitive spinal magnetic stimulation (SMS) in pain associated with lumbar spondylosis. In this study, we utilize SMS technique for patients with this condition in a pilot clinical trial. We randomized 20 patients into SMS treatment or placebo arms. All patients must have clinical and radiological evidence of lumbar spondylosis. Patients should present with pain in the lumbar region, localized or radiating down the lower limbs in a radicular distribution. SMS was delivered with a Medtronic R30 repetitive magnetic stimulator (Medtronic Corporation, Skovlunde, Denmark) connected to a C-B60 figure of eight coil capable of delivering a maximum output of 2 Tesla per pulse. The coil measured 90 mm in each wing and was centered over the surface landmark corresponding to the cauda equina region. The coil was placed flat over the back with the handle pointing cranially. Each patient on active treatment received 200 trains of five pulses delivered at 10 Hz, at an interval of 5 seconds between each train. "Sham" SMS was delivered with the coil angled vertically and one of the wing edges in contact with the stimulation point. All patients tolerated the procedure well and no side effects of SMS were reported. In the treatment arm, SMS had resulted in significant pain reduction immediately and at Day 4 after treatment (P < 0.05). In the placebo arm, however, no significant pain reduction was seen immediately and at Day 4 after SMS. SMS in the treatment arm had resulted in mean pain reduction of 62.3% postprocedure and 17.4% at Day 4. The placebo arm only achieved pain reduction of 6.1% postprocedure and 4.5% at Day 4. This is the first study to show that a single session of SMS resulted in significant improvement of pain associated with lumbar spondylosis in a randomized, double-blind, placebo-controlled setting. The novel findings support the potential of this technique for future studies pertaining to neuropathic pain. Wiley Periodicals, Inc.

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.

Shamba Maisha: Pilot agricultural intervention for food security and HIV health outcomes in Kenya: design, methods, baseline results and process evaluation of a cluster-randomized controlled trial.

PubMed

Cohen, Craig R; Steinfeld, Rachel L; Weke, Elly; Bukusi, Elizabeth A; Hatcher, Abigail M; Shiboski, Stephen; Rheingans, Richard; Scow, Kate M; Butler, Lisa M; Otieno, Phelgona; Dworkin, Shari L; Weiser, Sheri D

2015-01-01

Despite advances in treatment of people living with HIV, morbidity and mortality remains unacceptably high in sub-Saharan Africa, largely due to parallel epidemics of poverty and food insecurity. We conducted a pilot cluster randomized controlled trial (RCT) of a multisectoral agricultural and microfinance intervention (entitled Shamba Maisha) designed to improve food security, household wealth, HIV clinical outcomes and women's empowerment. The intervention was carried out at two HIV clinics in Kenya, one randomized to the intervention arm and one to the control arm. HIV-infected patients >18 years, on antiretroviral therapy, with moderate/severe food insecurity and/or body mass index (BMI) <18.5, and access to land and surface water were eligible for enrollment. The intervention included: 1) a microfinance loan (~$150) to purchase the farming commodities, 2) a micro-irrigation pump, seeds, and fertilizer, and 3) trainings in sustainable agricultural practices and financial literacy. Enrollment of 140 participants took four months, and the screening-to-enrollment ratio was similar between arms. We followed participants for 12 months and conducted structured questionnaires. We also conducted a process evaluation with participants and stakeholders 3-5 months after study start and at study end. Baseline results revealed that participants at the two sites were similar in age, gender and marital status. A greater proportion of participants at the intervention site had a low BMI in comparison to participants at the control site (18% vs. 7%, p = 0.054). While median CD4 count was similar between arms, a greater proportion of participants enrolled at the intervention arm had a detectable HIV viral load compared with control participants (49% vs. 28%, respectively, p < 0.010). Process evaluation findings suggested that Shamba Maisha had high acceptability in recruitment, delivered strong agricultural and financial training, and led to labor saving due to use of the water pump. Implementation challenges included participant concerns about repaying loans, agricultural challenges due to weather patterns, and a challenging partnership with the microfinance institution. We expect the results from this pilot study to provide useful data on the impacts of livelihood interventions and will help in the design of a definitive cluster RCT. This trial is registered at ClinicalTrials.gov, NCT01548599.

Development and validation of instrument for ergonomic evaluation of tablet arm chairs

PubMed Central

Tirloni, Adriana Seára; dos Reis, Diogo Cunha; Bornia, Antonio Cezar; de Andrade, Dalton Francisco; Borgatto, Adriano Ferreti; Moro, Antônio Renato Pereira

2016-01-01

The purpose of this study was to develop and validate an evaluation instrument for tablet arm chairs based on ergonomic requirements, focused on user perceptions and using Item Response Theory (IRT). This exploratory study involved 1,633 participants (university students and professors) in four steps: a pilot study (n=26), semantic validation (n=430), content validation (n=11) and construct validation (n=1,166). Samejima's graded response model was applied to validate the instrument. The results showed that all the steps (theoretical and practical) of the instrument's development and validation processes were successful and that the group of remaining items (n=45) had a high consistency (0.95). This instrument can be used in the furniture industry by engineers and product designers and in the purchasing process of tablet arm chairs for schools, universities and auditoriums. PMID:28337099

Embedding Sustainability in Education through Experiential Learning Using Innovation and Entrepreneurship

ERIC Educational Resources Information Center

Belkhir, Lotfi

2015-01-01

In this pedagogical study, we introduce the design and findings of a pilot study on the effectiveness of a new Engineering graduate course, "Total Sustainability Management", in teaching and learning sustainability, both at the cognitive and the management level. The design of an "arms-length" anonymized pre- and post-course…

Improving arm function in chronic stroke: a pilot study of sensory amplitude electrical stimulation via glove electrode during task-specific training.

PubMed

Sullivan, Jane; Girardi, Madeline; Hensley, Melissa; Rohaus, Jordan; Schewe, Clay; Whittey, Colby; Hansen, Piper; Muir, Kimberly

2015-06-01

To investigate the effects of sensory amplitude electrical stimulation (SES) delivered by glove electrode during task-specific exercise on arm movement, function, and sensation in chronic stroke. The design was an intervention pilot study, pre-test, post-test, follow-up design. The settings used were a university research laboratory and home-based intervention. Participants comprised of 11 individuals with chronic stroke (7.2 ± 4.1 years post onset) and moderate arm paresis, 10.82/20 ± 2.27 on the Stroke Rehabilitation Assessment of Movement (STREAM) - Arm Subscale. Participants were seven males and four females (mean age: 59 years). Participants were recruited from university-based database. Intervention- Participants engaged in task-specific training at home for 30 min, twice daily, for 5 weeks, while receiving SES via glove electrode. Participants received supervised task practice at least twice during intervention period for 1 hour. Main outcome measures- Jebsen-Taylor Hand Function Test (JTHFT), STREAM - Arm Subscale, Motor Activity Log-14 (MAL-14) - Amount and Quality Subscales, and Nottingham Stereognosis Assessment (NSA). Significant changes were found in group mean pre- and post-test comparisons on the NSA (P = 0.042), MAL amount subscale (P = 0.047), and JTHFT (with writing item 29 excluded) (P = 0.003) and in pre-test to follow-up comparisons on NSA (P = 0.027) and JTHFT (writing item excluded) (P = 0.009). There was no significant change on the STREAM (P = 1.0). Individuals with a greater baseline motor capacity determined by STREAM scores (P = 0.048) and more recent stroke (P = 0.014) had significantly greater improvements. Combining task-specific training with glove-based SES in chronic stroke resulted in changes in arm sensation and function that were maintained at 3-month follow-up.

The effect of an arm sling used for shoulder support on gait efficiency in hemiplegic patients with stroke using walking aids.

PubMed

Jeong, Yeon-Gyu; Jeong, Yeon-Jae; Koo, Jung-Wan

2017-06-01

The effects of an arm sling on the physiological costs of walking are not known. Even though a previous study reported that an arm sling can improve gait efficiency, its entrance criteria was only hemiparetic patients able to walk without walking aids independently. The aim of this study was to investigate the effect of shoulder support by an arm sling on gait efficiency in hemiplegic stroke patients using walking aids. Randomized crossover design. Rehabilitation department of a university hospital. A total of 57 hemiplegic patients with shoulder subluxation dependent on canes were grouped into single cane (N.=30) and quad cane groups (N.=27) as walking aids. All patients performed a walk with their own walking aid with and without an arm sling in randomized order, on the same day. We measured the energy cost and energy expenditure using a portable gas analyzer and heart rate during a 6-minutes Walk Test and a 10-m Walk Test. We analyzed all outcomes measures with and without an arm sling between the patients who were grouped according to their walking aids using 2-way repeated ANOVA. The energy cost (0.068±0.023 mL/kg/m) and oxygen expenditure (8.609±2.155 mL/kg/minutes) were lower with the arm sling (P<0.05) than without the arm sling (0.074±0.029 mL/kg/m, and 9.109±2.406 mL/kg/minutes, respectively), and the walking endurance (138.942±47.043 m) were longer (P<0.05) with the arm sling among the hemiplegic patients with single cane. Among the hemiplegic patients with a single cane, the walking endurance achieved with an arm sling significantly improved than those achieved without an arm sling, and the energy expenditure and energy cost was significantly lower. The hemiplegic arm support with an arm sling may be beneficial for gait efficiency in hemiplegic patients using a single cane, which lead to decreased oxygen use at a given speed.

Treatment of Lymphedema with Saam Acupuncture in Patients with Breast Cancer: A Pilot Study

PubMed Central

Jeong, Young Ju; Kwon, Hyo Jung; Park, Young Sun; Kwon, Oh Chang; Shin, Im Hee

2015-01-01

Abstract Background: Lymphedema is a troublesome complication affecting quality of life (QoL) in many women after breast-cancer treatment. Recent studies have suggested that acupuncture can reduce symptoms of lymphedema in breast-cancer survivors. Objectives: This was a pilot study. It was designed to assess the feasibility and the safety of acupuncture with the Saam acupuncture method for treating lymphedema in Korean patients after surgical therapy for breast cancer. Materials and Methods: This was a prospective, single-arm, observational pilot study using before and after measurements. The study was conducted at the East-West Medical Center at the Daegu Catholic University Medical Center, in Daegu, Korea. The subjects were 9 patients with breast cancer who presented with lymphedema of the upper limb ipsilateral to surgery. Saam acupuncture was administered 3 times per week for 6 consecutive weeks, for 30±5 minutes at each session.The primary outcome measure was severity of lymphedema as assessed by stages of lymphedema, a visual analogue scale (VAS), and by circumferential measurements of the upper extremity. The secondary outcome measure was QoL, which was assessed by a self-administered questionnaire using the Short Form–36 questionnaire. Results: Acupuncture reduced severity of lymphedema significantly, as assessed by the VAS (P<0.001) as well as by circumferential measurements of the upper extremity. Four weeks after the final treatment, symptoms were not aggravated. SF-36 scores remained significant for health status at the end of treatment. Conclusions: The Saam acupuncture method appeared to provide reduction of lymphedema among women after they had undergone surgery for breast cancer. A randomized, controlled prospective study with a larger sample size is required to clarify the role of acupuncture for managing lymphedema in patients with breast cancer. PMID:26155321

Educating restaurant owners and cooks to lower their own sodium intake is a potential strategy for reducing the sodium contents of restaurant foods: a small-scale pilot study in South Korea.

PubMed

Park, Sohyun; Lee, Heeseung; Seo, Dong-Il; Oh, Kwang-Hwan; Hwang, Taik Gun; Choi, Bo Youl

2016-12-01

This study was conducted to evaluate the feasibility of a sodium reduction program at local restaurants through nutrition education and examination of the health of restaurant owners and cooks. The study was a single-arm pilot intervention using a pre-post design in one business district with densely populated restaurants in Seoul, South Korea. The intervention focused on improving nutrition behaviors and psychosocial factors through education, health examination, and counseling of restaurant personnel. Forty-eight restaurant owners and cooks completed the baseline survey and participated in the intervention. Forty participants completed the post-intervention survey. The overweight and obesity prevalences were 25.6% and 39.5%, respectively, and 74.4% of participants had elevated blood pressure. After health examination, counseling, and nutrition education, several nutrition behaviors related to sodium intake showed improvement. In addition, those who consumed less salt in their baseline diet (measured with urine dipsticks) were more likely to agree that providing healthy foods to their customers is necessary. This study demonstrated the potential to reduce the sodium contents of restaurant foods by improving restaurant owners' and cooks' psychological factors and their own health behaviors. This small pilot study demonstrated that working with restaurant owners and cooks to improve their own health and sodium intake may have an effect on participation in restaurant-based sodium reduction initiatives. Future intervention studies with a larger sample size and comparison group can focus on improving the health and perceptions of restaurant personnel in order to increase the feasibility and efficacy of restaurant-based sodium reduction programs and policies.

Educating restaurant owners and cooks to lower their own sodium intake is a potential strategy for reducing the sodium contents of restaurant foods: a small-scale pilot study in South Korea

PubMed Central

Lee, Heeseung; Seo, Dong-il; Oh, Kwang-hwan; Hwang, Taik Gun; Choi, Bo Youl

2016-01-01

BACKGROUND/OBJECTIVES This study was conducted to evaluate the feasibility of a sodium reduction program at local restaurants through nutrition education and examination of the health of restaurant owners and cooks. SUBJECTS/METHODS The study was a single-arm pilot intervention using a pre-post design in one business district with densely populated restaurants in Seoul, South Korea. The intervention focused on improving nutrition behaviors and psychosocial factors through education, health examination, and counseling of restaurant personnel. Forty-eight restaurant owners and cooks completed the baseline survey and participated in the intervention. Forty participants completed the post-intervention survey. RESULTS The overweight and obesity prevalences were 25.6% and 39.5%, respectively, and 74.4% of participants had elevated blood pressure. After health examination, counseling, and nutrition education, several nutrition behaviors related to sodium intake showed improvement. In addition, those who consumed less salt in their baseline diet (measured with urine dipsticks) were more likely to agree that providing healthy foods to their customers is necessary. This study demonstrated the potential to reduce the sodium contents of restaurant foods by improving restaurant owners' and cooks' psychological factors and their own health behaviors. CONCLUSIONS This small pilot study demonstrated that working with restaurant owners and cooks to improve their own health and sodium intake may have an effect on participation in restaurant-based sodium reduction initiatives. Future intervention studies with a larger sample size and comparison group can focus on improving the health and perceptions of restaurant personnel in order to increase the feasibility and efficacy of restaurant-based sodium reduction programs and policies. PMID:27909562

A new progestogen-only medical therapy for outpatient management of acute, abnormal uterine bleeding: a pilot study.

PubMed

Ammerman, Stacy R; Nelson, Anita L

2013-06-01

The objective of this investigation was to study short-term efficacy and feasibility of a new progestogen-only treatment for outpatient management of acute abnormal uterine bleeding. This was a prospective, single-arm, pilot clinical trial of a progestogen-only bridging treatment for acute abnormal uterine bleeding in nonpregnant, premenopausal women in the Gynecologic Urgent Care Clinic at Harbor-UCLA Medical Center. Subjects were administered a depo-medroxyprogesterone acetate 150 mg intramuscular injection and given medroxyprogesterone acetate 20 mg to be taken orally every 8 hours for 3 days. The primary outcome measures included a percentage of women who stopped bleeding in 5 days, time to bleeding cessation, reduction in numbers of pads used, side effects, and patient satisfaction. All 48 women stopped bleeding within 5 days; 4 women had spotting only at the time of their last contact during the 5 day follow-up. Mean time to bleeding cessation was 2.6 days. Side effects were infrequent and patient satisfaction was high. Injection of depo-medroxyprogesterone acetate 150 mg intramuscularly combined with 3 days of oral medroxyprogesterone acetate 20 mg every 8 hours for 9 doses is an effective outpatient therapy for acute abnormal uterine bleeding. Copyright © 2013 Mosby, Inc. All rights reserved.

Unmanned Aerial Systems: Further Actions Needed to Fully Address Air Force and Army Pilot Workforce Challenges

DTIC Science & Technology

2016-03-16

UNMANNED AERIAL SYSTEMS Further Actions Needed to Fully Address Air Force and Army Pilot Workforce Challenges...Armed Services, U.S. Senate March 16, 2016 UNMANNED AERIAL SYSTEMS Further Actions Needed to Fully Address Air Force and Army Pilot Workforce ...High-performing organizations use complete and current data to inform their strategic human capital planning and remain open to reevaluating workforce

78 FR 11609 - Special Conditions: Embraer S.A., Model EMB-550 Airplane; Landing Pitchover Condition

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-19

... automatic braking system. The applicable airworthiness regulations do not contain adequate or appropriate... with an automatic braking system. This feature is a pilot-selectable function that allows earlier braking at landing without pilot pedal input. When the autobrake system is armed before landing, it...

14 CFR 25.735 - Brakes and braking systems.

Code of Federal Regulations, 2011 CFR

2011-01-01

... an automatic braking system is installed, means are provided to: (i) Arm and disarm the system, and (ii) Allow the pilot(s) to override the system by use of manual braking. (d) Parking brake. The airplane must have a parking brake control that, when selected on, will, without further attention, prevent...

14 CFR 25.735 - Brakes and braking systems.

Code of Federal Regulations, 2010 CFR

2010-01-01

... an automatic braking system is installed, means are provided to: (i) Arm and disarm the system, and (ii) Allow the pilot(s) to override the system by use of manual braking. (d) Parking brake. The airplane must have a parking brake control that, when selected on, will, without further attention, prevent...

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.

Bioelectric Control of a 757 Class High Fidelity Aircraft Simulation

NASA Technical Reports Server (NTRS)

Jorgensen, Charles; Wheeler, Kevin; Stepniewski, Slawomir; Norvig, Peter (Technical Monitor)

2000-01-01

This paper presents results of a recent experiment in fine grain Electromyographic (EMG) signal recognition, We demonstrate bioelectric flight control of 757 class simulation aircraft landing at San Francisco International Airport. The physical instrumentality of a pilot control stick is not used. A pilot closes a fist in empty air and performs control movements which are captured by a dry electrode array on the arm, analyzed and routed through a flight director permitting full pilot outer loop control of the simulation. A Vision Dome immersive display is used to create a VR world for the aircraft body mechanics and flight changes to pilot movements. Inner loop surfaces and differential aircraft thrust is controlled using a hybrid neural network architecture that combines a damage adaptive controller (Jorgensen 1998, Totah 1998) with a propulsion only based control system (Bull & Kaneshige 1997). Thus the 757 aircraft is not only being flown bioelectrically at the pilot level but also demonstrates damage adaptive neural network control permitting adaptation to severe changes in the physical flight characteristics of the aircraft at the inner loop level. To compensate for accident scenarios, the aircraft uses remaining control surface authority and differential thrust from the engines. To the best of our knowledge this is the first time real time bioelectric fine-grained control, differential thrust based control, and neural network damage adaptive control have been integrated into a single flight demonstration. The paper describes the EMG pattern recognition system and the bioelectric pattern recognition methodology.

A flow visualization study of single-arm sculling movement emulating cephalopod thrust generation

NASA Astrophysics Data System (ADS)

Kazakidi, Asimina; Gnanamanickam, Ebenezer P.; Tsakiris, Dimitris P.; Ekaterinaris, John A.

2014-11-01

In addition to jet propulsion, octopuses use arm-swimming motion as an effective means of generating bursts of thrust, for hunting, defense, or escape. The individual role of their arms, acting as thrust generators during this motion, is still under investigation, in view of an increasing robotic interest for alternative modes of propulsion, inspired by the octopus. Computational studies have revealed that thrust generation is associated with complex vortical flow patterns in the wake of the moving arm, however further experimental validation is required. Using the hydrogen bubble technique, we studied the flow disturbance around a single octopus-like robotic arm, undergoing two-stroke sculling movements in quiescent fluid. Although simplified, sculling profiles have been found to adequately capture the fundamental kinematics of the octopus arm-swimming behavior. In fact, variation of the sculling parameters alters considerably the generation of forward thrust. Flow visualization revealed the generation of complex vortical structures around both rigid and compliant arms. Increased disturbance was evident near the tip, particularly at the transitional phase between recovery and power strokes. These results are in good qualitative agreement with computational and robotic studies. Work funded by the ESF-GSRT HYDRO-ROB Project PE7(281).

Pilot randomised clinical trial of Pascal TargETEd Retinal versus variable fluence PANretinal 20 ms laser in diabetic retinopathy: PETER PAN study.

PubMed

Muqit, Mahiul M K; Young, Lorna B; McKenzie, Rod; John, Binu; Marcellino, George R; Henson, David B; Turner, George S; Stanga, Paulo E

2013-02-01

To investigate the short-term effects of high-density 20-ms laser on macular thickness using Pascal-targeted retinal photocoagulation (TRP) and reduced fluence/minimally-traumatic panretinal photocoagulation (MT-PRP) compared to standard-intensity PRP (SI-PRP) in proliferative diabetic retinopathy (PDR). Prospective randomised clinical trial. Treatment-naive PDR was treated with single-session 20-ms Pascal 2500 burns photocoagulation randomised to one of three treatment arms (TRP:MT-PRP:SI-PRP). Primary outcome measure was change in central retinal thickness (CRT) on OCT. Secondary outcomes at 4 and 12 weeks post-laser included: OCT peripapillary nerve fibre layer (NFL) thickness; PDR disease regression on Optos angiography; SITA-Std visual fields (VF); and, visual acuity (VA). 30 eyes of 24 patients were studied, ten eyes/arm. At 12 weeks, there were significant reductions in CRT after TRP (9.6 µm; 95% CI, 1.84 to 17.36; p=0.021) and MT-PRP (17.1 µm; 95% CI, 11 to 23.2; p=0.001), versus SI-PRP (+5.9 µm; 95% CI, -6.75 to 18.55; p=0.32). PDR regression was similar between groups (TRP 70%; MT-PRP 70%; SI-PRP 90%; κ=0.76). No significant changes in VA and NFL thickness developed between groups. The VF mean deviation scores increased significantly in all groups at 12 weeks ([TRP, +0.70dB; 95% CI, 0.07 to 1.48; p=0.07], [MT-PRP, +0.63dB; 95% CI, 0.12 to 1.15; p=0.02], [SI-PRP, +1.0dB; 95% CI, 0.19 to 1.74; p=0.02]). There were no laser-related ocular complications. This pilot study reports that high-density 20-ms Pascal TRP and MT-PRP using 2500 burns did not produce increased macular thickness or any ocular adverse events during the short-term.

Feasibility of a novel remote daily monitoring system for age-related macular degeneration using mobile handheld devices: results of a pilot study.

PubMed

Kaiser, Peter K; Wang, Yi-Zhong; He, Yu-Guang; Weisberger, Annemarie; Wolf, Stephane; Smith, Craig H

2013-10-01

This pilot study evaluated the feasibility of the Health Management Tool (HMT), a novel computing system using mobile handheld devices, to remotely monitor retinal visual function daily in patients with neovascular age-related macular degeneration treated with ranibizumab. Patients with neovascular age-related macular degeneration in at least 1 eye (newly diagnosed or successfully treated < 1 year) and eligible for ranibizumab therapy were enrolled in this 16-week, prospective, open-label, single-arm study. Patients performed a shape discrimination hyperacuity test (myVisionTrack [mVT]) daily on the HMT device (iPhone 3GS) remotely and at all clinic visits. Data entered into HMT devices were collected in the HMT database, which also sent reminders for patients to take mVT. Among 160 patients from 24 U.S. centers enrolled in the study (103 [64%] ≥ 75 years of age), 84.7% on average complied with daily mVT testing and ≈ 98.9% complied with at least weekly mVT testing. The HMT database successfully uploaded more than 17,000 mVT assessment values and sent more than 9,000 reminders. Elderly patients with neovascular age-related macular degeneration were willing and able to comply with daily self-testing of retinal visual function using mobile handheld devices in this novel system of remote vision monitoring.

Influence of gravity compensation training on synergistic movement patterns of the upper extremity after stroke, a pilot study

PubMed Central

2012-01-01

Background The majority of stroke patients have to cope with impaired arm function. Gravity compensation of the arm instantaneously affects abnormal synergistic movement patterns. The goal of the present study is to examine whether gravity compensated training improves unsupported arm function. Methods Seven chronic stroke patients received 18 half-hour sessions of gravity compensated reach training, in a period of six weeks. During training a motivating computer game was played. Before and after training arm function was assessed with the Fugl-Meyer assessment and a standardized, unsupported circle drawing task. Synergistic movement patterns were identified based on concurrent changes in shoulder elevation and elbow flexion/extension angles. Results Median increase of Fugl-Meyer scores was 3 points after training. The training led to significantly increased work area of the hemiparetic arm, as indicated by the normalized circle area. Roundness of the drawn circles and the occurrence of synergistic movement patterns remained similar after the training. Conclusions A decreased strength of involuntary coupling might contribute to the increased arm function after training. More research is needed to study working mechanisms involved in post stroke rehabilitation training. The used training setup is simple and affordable and is therefore suitable to use in clinical settings. PMID:22824488

Home-based Reach-to-Grasp training for people after stroke is feasible: a pilot randomised controlled trial.

PubMed

Turton, A J; Cunningham, P; van Wijck, F; Smartt, Hjm; Rogers, C A; Sackley, C M; Jowett, S; Wolf, S L; Wheatley, K; van Vliet, P

2017-07-01

To determine feasibility of a randomised controlled trial (RCT) of home-based Reach-to-Grasp training after stroke. single-blind parallel group RCT. Residual arm deficit less than 12 months post-stroke. Reach-to-Grasp training in 14 one-hour therapist's visits over 6 weeks, plus one hour self-practice per day (total 56 hours). Usual care. Action Research Arm Test (ARAT), Wolf Motor Function Test (WMFT), pre-randomisation, 7, 12, 24 weeks post-randomisation. Forty-seven participants (Reach-to-Grasp=24, usual care=23) were randomised over 17 months. Reach-to-Grasp participants received a median (IQR) 14 (13,14) visits, and performed 157 (96,211) repetitions per visit; plus 30 minutes (22,45) self-practice per day. Usual care participants received 10.5 (5,14) therapist visits, comprising 38.6 (30,45) minutes of arm therapy with 16 (6,24) repetitions of functional tasks per visit. Median ARAT scores in the reach-to-grasp group were 8.5 (3.0,24.0) at baseline and 14.5 (3.5,26.0) at 24 weeks compared to median of 4 at both time points (IQR: baseline (3.0,14.0), 24 weeks (3.0,30.0)) in the usual-care group. Median WMFT tasks completed at baseline and 24 weeks were 6 (3.0,11.5) and 8.5 (4.5,13.5) respectively in the reach-to-grasp group and 4 (3.0,10.0), 6 (3.0,14.0) in the usual care group. Incidence of arm pain was similar between groups. The study was stopped before 11 patients reached the 24 weeks assessment. An RCT of home-based Reach-to-Grasp training after stroke is feasible and safe. With ARAT being our preferred measure it is estimated that 240 participants will be needed for a future two armed trial.

HPTN 062: A Pilot Randomized Controlled Trial Exploring the Effect of a Motivational-Interviewing Intervention on Sexual Behavior among Individuals with Acute HIV Infection in Lilongwe, Malawi.

PubMed

Pettifor, Audrey; Corneli, Amy; Kamanga, Gift; McKenna, Kevin; Rosenberg, Nora E; Yu, Xuesong; Ou, San-San; Massa, Cecilia; Wiyo, Patricia; Lynn, Diana; Tharaldson, Jenae; Golin, Carol; Hoffman, Irving

2015-01-01

We pilot tested a Motivational Interviewing (MI) -based counseling intervention for individuals with Acute HIV Infection (AHI) to reduce risky sexual behavior in Lilongwe, Malawi. Twenty-eight individuals diagnosed with AHI were randomized to receive either brief education alone, or the brief education plus the MI-based intervention, called Uphungu Wanga. Participants in Uphungu Wanga received four sessions delivered on the day of diagnosis, three days later and at weeks 1 and 2 with a booster session at week 8; participants were followed for 24 weeks from diagnosis. An interviewer administered quantitative questionnaire was conducted at baseline and at weeks 2, 4, 8, 12, 16, 20 and 24. Semi-structured qualitative interviews (SSI) were conducted at weeks 2, 8, 12, and 24. The majority of participants in both arms reported rapid and sustained behavior change following diagnosis with AHI. Very few participants reported having sex without a condom after diagnosis. Participants reported a trend towards fewer sex partners and abstaining from sex during study follow-up. Participants in the MI-based arm provided concrete examples of risk reduction strategies in the SSIs while those in the brief education arm primarily described reducing risk behavior, suggesting that the MI-based group may have acquired more risk reduction skills. Individuals in both study arms reduced risky sexual behaviors after diagnosis with AHI. We found few major differences between study arms during the 6-month follow up period in self-reported sexual behaviors therefore a MI-based intervention may not be needed to trigger behavior change following AHI. However, comparing the MI-based intervention to repeated brief education sessions made it difficult to assess the potential benefit of an MI-based intervention in a setting where standard counseling often consists of one post-test session. Nevertheless, provision of counseling immediately following diagnosis with HIV to support behavior change should remain a priority. ClinicalTrials.gov NCT01197027.

Operational problems experienced by single pilots in instrument meteorological conditions

NASA Technical Reports Server (NTRS)

Weislogel, S.

1981-01-01

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

Pediatric Primary Care-Based Obesity Prevention for Parents of Preschool Children: A Pilot Study.

PubMed

Sherwood, Nancy E; JaKa, Meghan M; Crain, A Lauren; Martinson, Brian C; Hayes, Marcia G; Anderson, Julie D

2015-12-01

The Healthy Homes/Healthy Kids Preschool (HHHK-Preschool) pilot program is an obesity prevention intervention integrating pediatric care provider counseling and a phone-based program to prevent unhealthy weight gain among 2- to 4-year-old children at risk for obesity (BMI percentile between the 50th and 85th percentile and at least one overweight parent) or currently overweight (85th percentile ≤ BMI < 95th percentile). The aim of this randomized, controlled pilot study was to evaluate the feasibility, acceptability, and potential efficacy of the HHHK-Preschool intervention. Sixty parent-child dyads recruited from pediatric primary care clinics were randomized to: (1) the Busy Bodies/Better Bites Obesity Prevention Arm or the (2) Healthy Tots/Safe Spots safety/injury prevention Contact Control Arm. Baseline and 6-month data were collected, including measured height and weight, accelerometry, previous day dietary recalls, and parent surveys. Intervention process data (e.g., call completion) were also collected. High intervention completion and satisfaction rates were observed. Although a statistically significant time by treatment interaction was not observed for BMI percentile or BMI z-score, post-hoc examination of baseline weight status as a moderator of treatment outcome showed that the Busy Bodies/Better Bites obesity prevention intervention appeared to be effective among children who were in the overweight category at baseline relative to those who were categorized as at risk for obesity (p = 0.04). HHHK-Preschool pilot study results support the feasibility, acceptability, and potential efficacy in already overweight children of a pediatric primary care-based obesity prevention intervention integrating brief provider counseling and parent-targeted phone coaching. What's New: Implementing pediatric primary care-based obesity interventions is challenging. Previous interventions have primarily involved in-person sessions, a barrier to sustained parent involvement. HHHK-preschool pilot study results suggest that integrating brief provider counseling and parent-targeted phone coaching is a promising approach.

A Randomized Controlled Trial of a Cardiopulmonary Resuscitation Video in Advance Care Planning for Progressive Pancreas and Hepatobiliary Cancer Patients

PubMed Central

Volandes, Angelo E.; Chen, Ling Y.; Gary, Kristen A.; Li, Yuelin; Agre, Patricia; Levin, Tomer T.; Reidy, Diane L.; Meng, Raymond D.; Segal, Neil H.; Yu, Kenneth H.; Abou-Alfa, Ghassan K.; Janjigian, Yelena Y.; Kelsen, David P.; O'Reilly, Eileen M.

2013-01-01

Abstract Background Cardiopulmonary resuscitation (CPR) is an important advance directive (AD) topic in patients with progressive cancer; however such discussions are challenging. Objective This study investigates whether video educational information about CPR engenders broader advance care planning (ACP) discourse. Methods Patients with progressive pancreas or hepatobiliary cancer were randomized to an educational CPR video or a similar CPR narrative. The primary end-point was the difference in ACP documentation one month posttest between arms. Secondary end-points included study impressions; pre- and post-intervention knowledge of and preferences for CPR and mechanical ventilation; and longitudinal patient outcomes. Results Fifty-six subjects were consented and analyzed. Rates of ACP documentation (either formal ADs or documented discussions) were 40% in the video arm (12/30) compared to 15% in the narrative arm (4/26), OR=3.6 [95% CI: 0.9–18.0], p=0.07. Post-intervention knowledge was higher in both arms. Posttest, preferences for CPR had changed in the video arm but not in the narrative arm. Preferences regarding mechanical ventilation did not change in either arm. The majority of subjects in both arms reported the information as helpful and comfortable to discuss, and they recommended it to others. More deaths occurred in the video arm compared to the narrative arm, and more subjects died in hospice settings in the video arm. Conclusions This pilot randomized trial addressing downstream ACP effects of video versus narrative decision tools demonstrated a trend towards more ACP documentation in video subjects. This trend, as well as other video effects, is the subject of ongoing study. PMID:23725233

Hemodialysis Infection Prevention Protocols Ontario-Shower Technique (HIPPO-ST): A Pilot Randomized Trial.

PubMed

Kosa, S Daisy; Gafni, Amiram; House, Andrew A; Lawrence, JulieAnn; Moist, Louise; Nathoo, Bharat; Tam, Paul; Sarabia, Alicia; Thabane, Lehana; Wu, George; Lok, Charmaine E

2017-03-01

We developed the Hemodialysis Infection Prevention Protocols Ontario-Shower Technique (HIPPO-ST) to permit hemodialysis (HD) patients with central venous catheters (catheters) to shower without additional infection risk. Our primary objective was to determine the feasibility of conducting a parallel randomized controlled trial (RCT) to evaluate the impact of HIPPO-ST on catheter-related bacteremia (CRB) in adult HD patients. Adult HD patients using catheters were recruited from 11 HD units. Patients were randomized to receive HIPPO-ST or standard care and were followed up for 6 months. Only CRB-outcome assessors were blinded. For the study to be considered feasible, 4 of 5 feasibility outcomes, each with its own statistical threshold for success, must have been achieved. A total of 68 patients were randomized (33 HIPPO-ST and 35 control) and were followed up to 6 months. Of 5 measures of feasibility, 4 were achieved: (1) accurate CRB rate documented (threshold: κ level >0.80); (2) 97.8% (279/285) of satellite HD patients with catheters were screened (threshold: >95%); (3) 88% (23/26) in the HIPPO-ST arm were successfully educated by 6 months (threshold: >80%); and (4) 0% (0/29) patients in the control arm were "contaminated," that is, using HIPPO-ST (threshold: <5%). However, only 44.2% (72/163) of eligible patients consented to participate (threshold: >80%). The rate of CRB was similarly low in HIPPO-ST and control groups (0.68 vs. 0.88/1000 catheter days). This HIPPO-ST pilot study demonstrated the feasibility of the larger HIPPO-ST study, especially given the high levels of education success with the HIPPO-ST arm and the low levels of contamination in the control arm.

Intravitreal ranibizumab as an adjunct for Ahmed valve surgery in open-angle glaucoma: a pilot study.

PubMed

Desai, Rajen U; Singh, Kuldev; Lin, Shan C

2013-03-01

To determine the safety and efficacy of intravitreal ranibizumab therapy before and after Ahmed tube insertion for open-angle glaucoma as a means of optimizing postoperative intraocular pressure control. Randomized, controlled trial. Open-angle glaucoma patients scheduled for Ahmed tube insertion, randomized to ranibizumab or control groups. Ranibizumab (0.5 mg in 0.05 mL) was administered intravitreally at three time points: 9 days prior to surgery, 1 month post-surgery and 2 months post-surgery. Control patients underwent the same procedure without ranibizumab. Success at 6 months postoperatively was defined as intraocular pressure <18 mmHg with no adjunctive medications or intraocular pressure <15 mmHg with one adjunctive medication. The study and control arms included six and five subjects, respectively, with four in each arm undergoing combined cataract surgery. In the ranibizumab arm, the preoperative and postoperative intraocular pressure/medication usage was 21.0 ± 6.7 mmHg on 3.2 ± 1.5 medications and 14.7 ± 1.9 mmHg on 0.5 ± 0.8 medications, respectively. In the control arm, preoperative and postoperative intraocular pressure/medication usage was 18.8 ± 3.8 mmHg on 2.8 ± 1.3 medications and 16.2 ± 3.6 mmHg with 1.8 ± 1.6 medications, respectively. Success was achieved in 83% of subjects in the ranibizumab group compared with 40% in the control group (two-tailed Fisher's exact test, P = 0.24). The findings from this small pilot comparative study suggest that intravitreal ranibizumab use may be a safe and potentially effective adjunctive treatment modality in improving success after Ahmed tube placement. © 2012 The Authors. Clinical and Experimental Ophthalmology © 2012 Royal Australian and New Zealand College of Ophthalmologists.

A behavioral weight-loss intervention for persons with serious mental illness in psychiatric rehabilitation centers.

PubMed

Daumit, G L; Dalcin, A T; Jerome, G J; Young, D R; Charleston, J; Crum, R M; Anthony, C; Hayes, J H; McCarron, P B; Khaykin, E; Appel, L J

2011-08-01

Overweight and obesity are epidemic in populations with serious mental illnesses. We developed and pilot-tested a behavioral weight-loss intervention appropriately tailored for persons with serious mental disorders. We conducted a single-arm pilot study in two psychiatric rehabilitation day programs in Maryland, and enrolled 63 overweight or obese adults. The 6-month intervention provided group and individual weight management and group physical activity classes. The primary outcome was weight change from baseline to 6 months. A total of 64% of those potentially eligible enrolled at the centers. The mean age was 43.7 years; 56% were women; 49% were white; and over half had schizophrenia or a schizoaffective disorder. One-third had hypertension and one-fifth had diabetes. In total, 52 (82%) completed the study; others were discharged from psychiatric centers before completion of the study. Average attendance across all weight management sessions was 70% (87% on days participants attended the center) and 59% for physical activity classes (74% on days participants attended the center). From a baseline mean of 210.9 lbs (s.d. 43.9), average weight loss for 52 participants was 4.5 lb (s.d. 12.8) (P<0.014). On average, participants lost 1.9% of body weight. Mean waist circumference change was 3.1 cm (s.d. 5.6). Participants on average increased the distance on the 6-minute walk test by 8%. This pilot study documents the feasibility and preliminary efficacy of a behavioral weight-loss intervention in adults with serious mental illness who were attendees at psychiatric rehabilitation centers. The results may have implications for developing weight-loss interventions in other institutional settings such as schools or nursing homes.

Once-daily, oral levofloxacin monotherapy for low-risk neutropenic fever in cancer patients: a pilot study in China

PubMed Central

He, Lixian; Zhao, Su; Weng, Heng; Yang, Guowang

2015-01-01

This pilot study assesses the safety and efficacy of once-daily, oral levofloxacin monotherapy in Chinese patients with low-risk febrile neutropenia. In this prospective, single-arm, open-label, multicenter clinical trial, 46 adult Chinese patients with solid tumors and low-risk febrile neutropenia were included. Patients received oral levofloxacin monotherapy (500 mg orally/day) until day 12, followed by 7 days of follow-up (day 19). Body temperature was measured three times per day. On days 2, 3, 5–7, 9, 12, and 19, disease symptoms and vital signs were recorded, adverse drug reactions were assessed, and blood samples were collected to determine the whole-blood cell count and the absolute neutrophil count. Blood cultures and chest radiographs were performed simultaneously until negative results were found. Oral levofloxacin was effective and well tolerated in 97.6% of patients irrespective of the cancer type and cause of fever. Body temperature began to decline in 24.4, 68.3, and 90.2% of patients, respectively, at 12, 24, and 48 h after initiating levofloxacin therapy. On days 5 and 7, 95.1 and 97.6% of the patients had complete defervescence, respectively. The median time for absolute neutrophil count recovery to at least 1500/mm3 after initiation of treatment was 3 days. Only one patient reported mild diarrhea. This pilot study showed that oral levofloxacin quickly and effectively reduced fever, initiated neutrophil recovery, and was well tolerated in Chinese low-risk febrile neutropenic patients with solid tumors. Further study is needed to compare patient data of levofloxacin with the standard amoxicillin/ciprofloxacin protocol in this population for both safety and efficacy. PMID:25486597

Transforaminal lumbar interbody graft placement using an articulating delivery arm facilitates increased segmental lordosis with superior anterior and midline graft placement.

PubMed

Shau, David N; Parker, Scott L; Mendenhall, Stephen K; Zuckerman, Scott L; Godil, Saniya S; Devin, Clinton J; McGirt, Matthew J

2015-05-01

Transforaminal lumbar interbody fusion (TLIF) is a frequently performed method of lumbar arthrodesis in patients failing medical management of back and leg pain. Accurate placement of the interbody graft and restoration of lordosis has been shown to be crucial when performing lumbar fusion procedures. We performed a single-surgeon, prospective, randomized study to determine whether a novel articulating versus traditional straight graft delivery arm system allows for superior graft placement and increased lordosis for single-level TLIF. Thirty consecutive patients undergoing single-level TLIF were included and prospectively randomized to one of the 2 groups (articulated vs. straight delivery arm system). Three radiographic characteristics were evaluated at 6-week follow-up: (1) degree of segmental lumbar lordosis at the fused level; (2) the percent anterior location of the interbody graft in disk space; and (3) the distance (mm) off midline of the interbody graft placement. Randomization yielded 16 patients in the articulated delivery arm cohort and 14 in the straight delivery arm cohort. The articulating delivery arm system yielded an average of 14.7-degree segmental lordosis at fused level, 35% anterior location, and 3.6 mm off midline. The straight delivery arm system yielded an average of 10.7-degree segmental lordosis at fused level, 46% anterior location, and 7.0 mm off midline. All 3 comparisons were statistically significant (P<0.05). The study suggests that an articulating delivery arm system facilitates superior anterior and midline TLIF graft placement allowing for increased segmental lordosis compared with a traditional straight delivery arm system.

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.

Patient participation in cancer clinical trials: A pilot test of lay navigation.

PubMed

Cartmell, Kathleen B; Bonilha, Heather S; Matson, Terri; Bryant, Debbie C; Zapka, Jane G; Bentz, Tricia A; Ford, Marvella E; Hughes-Halbert, Chanita; Simpson, Kit N; Alberg, Anthony J

2016-08-15

Clinical trials (CT) represent an important treatment option for cancer patients. Unfortunately, patients face challenges to enrolling in CTs, such as logistical barriers, poor CT understanding and complex clinical regimens. Patient navigation is a strategy that may help to improve the delivery of CT education and support services. We examined the feasibility and initial effect of one navigation strategy, use of lay navigators. A lay CT navigation intervention was evaluated in a prospective cohort study among 40 lung and esophageal cancer patients. The intervention was delivered by a trained lay navigator who viewed a 17-minute CT educational video with each patient, assessed and answered their questions about CT participation and addressed reported barriers to care and trial participation. During this 12-month pilot project, 85% (95% CI: 72%-93%) of patients eligible for a therapeutic CT consented to participate in the CT navigation intervention. Among navigated patients, CT understanding improved between pre- and post-test (means 3.54 and 4.40, respectively; p-value 0.004), and 95% (95% CI: 82%-98%) of navigated patients consented to participate in a CT. Navigated patients reported being satisfied with patient navigation services and CT participation. In this formative single-arm pilot project, initial evidence was found for the potential effect of a lay navigation intervention on CT understanding and enrollment. A randomized controlled trial is needed to examine the efficacy of the intervention for improving CT education and enrollment.

Integrative exercise and lifestyle intervention increases leisure-time activity in breast cancer patients.

PubMed

Casla, Soraya; Hojman, Pernille; Cubedo, Ricardo; Calvo, Isabel; Sampedro, Javier; Barakat, Ruben

2014-11-01

Physical activity has been demonstrated to increase survival in breast cancer patients, but few breast cancer patients meet the general recommendations for physical activity. The aim of this pilot study was to investigate if a supervised integrated counseling and group-based exercise program could increase leisure-time activity in women with breast cancer. This pilot project, designed as a single-arm study with pre-post testing, consisted of 24 classes of combined aerobic and strength exercise training as well as classes on dietary and health behavior. A total of 48 women with breast cancer who were undergoing or had recently completed anticancer treatment completed the study. Leisure-time physical activity, grip strength, functional capacity, quality of life (QoL), and depression were assessed at baseline, after intervention, and at the 12-week follow-up after intervention. The breast cancer patients increased their leisure-time physical activity (P = .004), global strength (P = .004), functional capacity (P = .001), and QoL (P = .009), and their depression score (P = .004) significantly decreased. These improvements were independent of whether the patients were in ongoing therapy or had completed their treatment. This integrated intervention may produce lifestyle changes in breast cancer patients and survivors using the teachable moment to increase their leisure-time physical activity and, thereby, their QoL. © The Author(s) 2014.

A Prototype Robotic Arm for Use by Severely Orthopedically Handicapped Students. Final Report.

ERIC Educational Resources Information Center

Howell, Richard

This 18-month pilot project, which ran from October 1, 1987 to March 31, 1989, developed a prototype robotic arm for educational use by students with severe orthopedic disabilities in the Columbus (Ohio) Public Schools. The developmental effort was intended first, to provide direct access to currently available instructional materials and, second,…

GestationaL Obesity Weight management: Implementation of National Guidelines (GLOWING): a pilot cluster randomised controlled trial of a guideline implementation intervention for the management of maternal obesity by midwives.

PubMed

Heslehurst, Nicola; Rankin, Judith; McParlin, Catherine; Sniehotta, Falko F; Howel, Denise; Rice, Stephen; McColl, Elaine

2018-01-01

Weight management in pregnancy guidelines exist, although dissemination alone is an ineffective means of implementation. Midwives identify the need for support to overcome complex barriers to practice. An evaluation of an intervention to support midwives' guideline implementation would require a large-scale cluster randomised controlled trial. A pilot study is necessary to explore the feasibility of delivery and evaluation prior to a definitive trial. The GestationaL Obesity Weight management: Implementation of National Guidelines (GLOWING) trial aims to test whether it is feasible and acceptable to deliver a behaviour change intervention to support midwives' implementation of weight management guidelines. GLOWING is a multi-centre parallel group pilot cluster randomised controlled trial comparing the delivery of a behaviour change intervention for midwives versus usual practice. Four NHS Trusts (clusters) will be randomised to intervention and control arms, stratified by size of maternity services. The intervention uses social cognitive theory and consists of face-to-face midwifery training plus information resources for routine practice. The main outcomes are whether the intervention and trial procedures are feasible and acceptable to participants and the feasibility of recruitment and data collection for a definitive trial. Target recruitment involves all eligible midwives in the intervention arm recruited to receive the intervention, 30 midwives and pregnant women per arm for baseline and outcome questionnaire data collection and 20 midwives and women to provide qualitative data. All quantitative and qualitative analyses will be descriptive with the purpose of informing the development of the definitive trial. This pilot study has been developed to support community midwives' implementation of guidelines. Community midwives have been selected as they usually carry out the booking appointment which includes measuring and discussing maternal body mass index. A cluster design is the gold standard in implementation research as there would be a high risk of contamination if randomisation was at individual midwife level: community midwives usually work in locality-based teams, interact on a daily basis, and share care of pregnant women. The results of the pilot trial will be used to further develop and refine GLOWING prior to a definitive trial to evaluate effectiveness and cost-effectiveness. ISRCTN46869894; retrospectively registered 25th May 2016.

Development and Feasibility of a COPD Self-Management Intervention Delivered with Motivational Interviewing Strategies

PubMed Central

Benzo, Roberto; Vickers, Kristin; Ernst, Denise; Tucker, Sharon; McEvoy, Charlene; Lorig, Kate

2013-01-01

BACKGROUND Self-management (SM) is proposed as the standard of care in chronic obstructive pulmonary disease (COPD) but details of the process and training required to deliver effective SM are not widely available. In addition, recent data suggest that patient engagement and motivation are critical ingredients for effective self-management. This manuscript carefully describes a self-management intervention using Motivational Interviewing skills, aimed to increase engagement and commitment in severe COPD patients. METHODS The intervention was developed and pilot tested for fidelity to protocol, for patient and interventionist feedback (qualitative) and effect on quality of life. Engagement between patient and interventionists was measured by the Working Alliance Inventory. The intervention was refined based in the results of the pilot study and delivered in the active arm of a prospective randomized study. RESULTS The pilot study suggested improvements in quality of life, fidelity to theory and patient acceptability. The refined self-management intervention was delivered 540 times in the active arm of a randomized study. We observed a retention rate of 86% (patients missing or not available for only 14% the scheduled encounters). CONCLUSIONS A self-management intervention, that includes motivational interviewing as the way if guiding patient into behavior change, is feasible in severe COPD and may increase patient engagement and commitment to self-management. This provides a very detailed description of the SM process for (the specifics of training and delivering the intervention) that facilitates replicability in other settings and could be translated to cardiac rehabilitation. PMID:23434613

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

PubMed

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

2017-01-01

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

Single-camera visual odometry to track a surgical X-ray C-arm base.

PubMed

Esfandiari, Hooman; Lichti, Derek; Anglin, Carolyn

2017-12-01

This study provides a framework for a single-camera odometry system for localizing a surgical C-arm base. An application-specific monocular visual odometry system (a downward-looking consumer-grade camera rigidly attached to the C-arm base) is proposed in this research. The cumulative dead-reckoning estimation of the base is extracted based on frame-to-frame homography estimation. Optical-flow results are utilized to feed the odometry. Online positional and orientation parameters are then reported. Positional accuracy of better than 2% (of the total traveled distance) for most of the cases and 4% for all the cases studied and angular accuracy of better than 2% (of absolute cumulative changes in orientation) were achieved with this method. This study provides a robust and accurate tracking framework that not only can be integrated with the current C-arm joint-tracking system (i.e. TC-arm) but also is capable of being employed for similar applications in other fields (e.g. robotics).

The SPORTSMART study: a pilot randomised controlled trial of sexually transmitted infection screening interventions targeting men in football club settings

PubMed Central

Fuller, Sebastian S; Mercer, Catherine H; Copas, Andrew J; Saunders, John; Sutcliffe, Lorna J; Cassell, Jackie A; Hart, Graham; Johnson, Anne M; Roberts, Tracy E; Jackson, Louise J; Muniina, Pamela; Estcourt, Claudia S

2015-01-01

Background Uptake of chlamydia screening by men in England has been substantially lower than by women. Non-traditional settings such as sports clubs offer opportunities to widen access. Involving people who are not medically trained to promote screening could optimise acceptability. Methods We developed two interventions to explore the acceptability and feasibility of urine-based sexually transmitted infection (STI) screening interventions targeting men in football clubs. We tested these interventions in a pilot cluster randomised control trial. Six clubs were randomly allocated, two to each of three trial arms: team captain-led and poster STI screening promotion; sexual health adviser-led and poster STI screening promotion; and poster-only STI screening promotion (control/comparator). Primary outcome was test uptake. Results Across the three arms, 153 men participated in the trial and 90 accepted the offer of screening (59%, 95% CI 35% to 79%). Acceptance rates were broadly comparable across the arms: captain-led: 28/56 (50%); health professional-led: 31/46 (67%); and control: 31/51 (61%). However, rates varied appreciably by club, precluding formal comparison of arms. No infections were identified. Process evaluation confirmed that interventions were delivered in a standardised way but the control arm was unintentionally ‘enhanced’ by some team captains actively publicising screening events. Conclusions Compared with other UK-based community screening models, uptake was high but gaining access to clubs was not always easy. Use of sexual health advisers and team captains to promote screening did not appear to confer additional benefit over a poster-promoted approach. Although the interventions show potential, the broader implications of this strategy for UK male STI screening policy require further investigation. PMID:25512674

Changing eating behaviours to treat childhood obesity in the community using Mandolean: the Community Mandolean randomised controlled trial (ComMando)--a pilot study.

PubMed

Hamilton-Shield, Julian; Goodred, Joanna; Powell, Lesley; Thorn, Joanna; Banks, Jon; Hollinghurst, Sandra; Montgomery, Alan; Turner, Katrina; Sharp, Debbie

2014-07-01

Around one in five children in England is obese when they leave primary school. Thus far, it has not been demonstrated that primary care interventions to manage childhood obesity can achieve significant weight reduction. Training obese children to eat more slowly as an adjunct to other healthy lifestyle behaviour change has been shown to increase weight reduction in a hospital setting. This pilot study aimed to test recruitment strategies, treatment adherence, clinic attendance and participants' experiences of using a device [Mandolean® (previously Mandometer®, Mikrodidakt AB, Lund, Sweden)] to slow down speed of eating as an adjunct to dietary and activity advice in treating obesity in primary school-aged children. A two-arm, parallel, randomised controlled trial with a qualitative study embedded within the pilot. Randomisation occurred after informed consent and baseline measures were collected. Participants were randomised by the Bristol Randomised Trials Collaboration randomisation service with allocation stratified by hub and minimised by age of the child, gender, and baseline body mass index (BMI) standard deviation score (BMI z-value) of the child, and by BMI of the study parent (obese/not obese). General practices across Bristol, North Somerset and South Gloucestershire primary care trusts. Children (BMI ≥ 95th percentile) aged 5-11 years and their families. Standard care comprised dietary and activity advice by trained practice nurses. Adjunctive Mandolean training (the intervention) educated participants to eat meals more slowly and to rate levels of fullness (satiety). Mandolean is a small computer device attached to a weighing scale that provides visual and oral feedback during meals while generating a visual representation of levels of satiety during the meal. Participants were encouraged to eat their main meal each day from the Mandolean. One parent was also given a Mandolean to use when eating with the child. Outcomes for the pilot were recruitment of 36 families to the trial in the 9-month pilot phase, that meals would be eaten at least five times a week off a Mandolean by 90% of patients randomised to the intervention arm, that 80% of patients in both arms would attend the weight management clinic appointment 3 months post randomisation and that > 60% of children using Mandolean would demonstrate a reduction in speed of eating from baseline within 3 months of randomisation. None of the criteria for progression to the main trial were reached. Despite numerous pathways being available for referral, only 21 (13 to standard care, eight to intervention arm; 58%) of the target 36 families were recruited in the pilot phase. Less than 20% of those randomised to Mandolean used the device at least five times a week. The > 60% target for slowing down of eating speed by 3 months was unmet. Attendance at the weight management clinic in general practice hubs for both arms of the study at 3 months was 44% against a target of 80%. This pilot trial failed to meet its objectives in terms of recruitment, treatment adherence, demonstration of a reduction in speed of eating in sufficient numbers of children, and attendance at follow-up appointments. Despite a high prevalence of childhood obesity in the geographical area and practices signing up for the trial, this study, like many others, demonstrates a failure of families to engage with and respond to primary care weight management interventions. We need to understand why the target population seems inured to the health message that childhood obesity is a significant health-care issue and identify the barriers to seeking help and then acting on positive health behaviour retraining. Only when we have fully understood the general public's perceptions of childhood obesity and have identified ways of engaging target populations can we hope to develop interventions that can work in a primary or community-based setting. Current Controlled Trials ISRCTN90561114. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 47. See the NIHR Journals Library website for further project information.

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

NASA Technical Reports Server (NTRS)

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

2017-01-01

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

Effects of a parallel arm randomized controlled weight loss pilot study on biological and psychosocial parameters of overweight and obese breast cancer survivors

USDA-ARS?s Scientific Manuscript database

Background: Weight gain often occurs after breast cancer (BC) diagnosis, and obesity along with sedentary behavior, are associated with increased risk of BC recurrence and mortality. The purpose of this study was to examine effects of weight loss and exercise on body composition, fitness, cancer-rel...

Network meta-analysis combining individual patient and aggregate data from a mixture of study designs with an application to pulmonary arterial hypertension.

PubMed

Thom, Howard H Z; Capkun, Gorana; Cerulli, Annamaria; Nixon, Richard M; Howard, Luke S

2015-04-12

Network meta-analysis (NMA) is a methodology for indirectly comparing, and strengthening direct comparisons of two or more treatments for the management of disease by combining evidence from multiple studies. It is sometimes not possible to perform treatment comparisons as evidence networks restricted to randomized controlled trials (RCTs) may be disconnected. We propose a Bayesian NMA model that allows to include single-arm, before-and-after, observational studies to complete these disconnected networks. We illustrate the method with an indirect comparison of treatments for pulmonary arterial hypertension (PAH). Our method uses a random effects model for placebo improvements to include single-arm observational studies into a general NMA. Building on recent research for binary outcomes, we develop a covariate-adjusted continuous-outcome NMA model that combines individual patient data (IPD) and aggregate data from two-arm RCTs with the single-arm observational studies. We apply this model to a complex comparison of therapies for PAH combining IPD from a phase-III RCT of imatinib as add-on therapy for PAH and aggregate data from RCTs and single-arm observational studies, both identified by a systematic review. Through the inclusion of observational studies, our method allowed the comparison of imatinib as add-on therapy for PAH with other treatments. This comparison had not been previously possible due to the limited RCT evidence available. However, the credible intervals of our posterior estimates were wide so the overall results were inconclusive. The comparison should be treated as exploratory and should not be used to guide clinical practice. Our method for the inclusion of single-arm observational studies allows the performance of indirect comparisons that had previously not been possible due to incomplete networks composed solely of available RCTs. We also built on many recent innovations to enable researchers to use both aggregate data and IPD. This method could be used in similar situations where treatment comparisons have not been possible due to restrictions to RCT evidence and where a mixture of aggregate data and IPD are available.

SUGAR: spotting undiagnosed glucose abnormal results--a new protocol to increase postpartum testing among women with gestational diabetes mellitus.

PubMed

Carson, Michael P; Morgan, Benjamin; Gussman, Debra; Brown, Monica; Rothenberg, Karen; Wisner, Theresa A

2015-02-01

Over 70% of women with gestational diabetes mellitus (GDM) will develop diabetes mellitus (DM), but only 30% follow through with the recommended postpartum oral glucose tolerance testing (OGTT). HbA1c is approved to diagnose DM, and combined with a fasting plasma glucose it can identify 93% of patients with dysglycemia. We tested the hypothesis that a single blood draw to assess for dysglycemia at the postpartum visit could improve testing rates compared with those required to obtain an OGTT at an outside laboratory. Prospective cohort study of all women with GDM who delivered between July 2010 and December 2011. When insurance status required testing at an outside laboratory an OGTT was ordered, when insurance allowed testing at our center a random sugar and HbA1c were drawn at the postpartum visit (SUGAR Protocol). Of the 40 women, 36 attended a postpartum visit. In the SUGAR arm, 19 of 19 (100%) were tested versus 9 of 17 (53%) in the OGTT arm; relative risk of testing was 1.9 (95% confidence interval, 1.2-3.0). 36% were glucose intolerant. This pilot study found that an in-office testing model doubled the rate of postpartum testing in this clinic population, and was reasonably sensitive at detecting dysglycemia. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Using the Habit App for Weight Loss Problem Solving: Development and Feasibility Study.

PubMed

Pagoto, Sherry; Tulu, Bengisu; Agu, Emmanuel; Waring, Molly E; Oleski, Jessica L; Jake-Schoffman, Danielle E

2018-06-20

Reviews of weight loss mobile apps have revealed they include very few evidence-based features, relying mostly on self-monitoring. Unfortunately, adherence to self-monitoring is often low, especially among patients with motivational challenges. One behavioral strategy that is leveraged in virtually every visit of behavioral weight loss interventions and is specifically used to deal with adherence and motivational issues is problem solving. Problem solving has been successfully implemented in depression mobile apps, but not yet in weight loss apps. This study describes the development and feasibility testing of the Habit app, which was designed to automate problem-solving therapy for weight loss. Two iterative single-arm pilot studies were conducted to evaluate the feasibility and acceptability of the Habit app. In each pilot study, adults who were overweight or obese were enrolled in an 8-week intervention that included the Habit app plus support via a private Facebook group. Feasibility outcomes included retention, app usage, usability, and acceptability. Changes in problem-solving skills and weight over 8 weeks are described, as well as app usage and weight change at 16 weeks. Results from both pilots show acceptable use of the Habit app over 8 weeks with on average two to three uses per week, the recommended rate of use. Acceptability ratings were mixed such that 54% (13/24) and 73% (11/15) of participants found the diet solutions helpful and 71% (17/24) and 80% (12/15) found setting reminders for habits helpful in pilots 1 and 2, respectively. In both pilots, participants lost significant weight (P=.005 and P=.03, respectively). In neither pilot was an effect on problem-solving skills observed (P=.62 and P=.27, respectively). Problem-solving therapy for weight loss is feasible to implement in a mobile app environment; however, automated delivery may not impact problem-solving skills as has been observed previously via human delivery. ClinicalTrials.gov NCT02192905; https://clinicaltrials.gov/ct2/show/NCT02192905 (Archived by WebCite at http://www.webcitation.org/6zPQmvOF2). ©Sherry Pagoto, Bengisu Tulu, Emmanuel Agu, Molly E Waring, Jessica L Oleski, Danielle E Jake-Schoffman. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 20.06.2018.

Does treatment by a specialist physiotherapist change pain and function in young adults with symptoms from femoroacetabular impingement? A pilot project for a randomised controlled trial.

PubMed

Smeatham, Alison; Powell, Roy; Moore, Sarah; Chauhan, Rohan; Wilson, Matthew

2017-06-01

Femoroacetabular impingement (FAI) is recognised as a source of hip pain but the effect of conservative treatment remains untested. This pilot study aimed to inform and evaluate the methods required to conduct a substantive trial comparing the effect of treatment by a physiotherapist versus routine care on the symptoms of FAI. A parallel group, pilot randomised controlled trial (RCT). A single NHS acute hospital trust, Devon, England. 30 adults with symptomatic FAI were recruited. 23 (77%) completed the study. Intervention was 3 months of treatment by a specialist physiotherapist. The control group received routine care. Change in pain and function was measured using a Visual Analogue Scale, Non Arthritic Hip Score (NAHS), Lower Extremity Functional Score (LEFS) and Hip Outcome Score. Participants in the intervention arm undertook a personalised exercise programme to improve pelvic and femoral control plus advice on posture, activity pacing and pain relief. The mean change in NAHS for the intervention group was 12.7 (95% CI 4.7 to 20.7) and 1.8 (95% CI -5.3 to 9.0) in the control group; Median change in LEFS was 11.5 (95% CI 5.0 to 26.0) versus -1.0 (95% CI -7.0 to 4.0). This improvement in LEFS was beyond minimal clinically important difference in the intervention group. Pain scores improved marginally in both groups. Methodological strengths and weaknesses were successfully identified for a substantive study. Further research is needed to evaluate the relative influence of structural and neuromuscular features on symptoms of FAI and the role of conservative treatment. Copyright © 2016 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Antireflux Metal Stent as a First-Line Metal Stent for Distal Malignant Biliary Obstruction: A Pilot Study.

PubMed

Hamada, Tsuyoshi; Isayama, Hiroyuki; Nakai, Yousuke; Togawa, Osamu; Takahara, Naminatsu; Uchino, Rie; Mizuno, Suguru; Mohri, Dai; Yagioka, Hiroshi; Kogure, Hirofumi; Matsubara, Saburo; Yamamoto, Natsuyo; Ito, Yukiko; Tada, Minoru; Koike, Kazuhiko

2017-01-15

In distal malignant biliary obstruction, an antireflux metal stent (ARMS) with a funnel-shaped valve is effective as a reintervention for metal stent occlusion caused by reflux. This study sought to evaluate the feasibility of this ARMS as a first-line metal stent. Patients with nonresectable distal malignant biliary obstruction were identified between April and December 2014 at three Japanese tertiary centers. We retrospectively evaluated recurrent biliary obstruction and adverse events after ARMS placement. In total, 20 consecutive patients were included. The most common cause of biliary obstruction was pancreatic cancer (75%). Overall, recurrent biliary obstruction was observed in seven patients (35%), with a median time to recurrent biliary obstruction of 246 days (range, 11 to 246 days). Stent occlusion occurred in five patients (25%), the causes of which were sludge and food impaction in three and two patients, respectively. Stent migration occurred in two patients (10%). The rate of adverse events associated with ARMS was 25%: pancreatitis occurred in three patients, cholecystitis in one and liver abscess in one. No patients experienced nonocclusion cholangitis. The ARMS as a first-line biliary drainage procedure was feasible. Because the ARMS did not fully prevent stent dysfunction due to reflux, further investigation is warranted.

The feasibility and benefit of a brief psychosocial intervention in addition to early palliative care in patients with advanced cancer to reduce depressive symptoms: a pilot randomized controlled clinical trial.

PubMed

do Carmo, Thamires Monteiro; Paiva, Bianca Sakamoto Ribeiro; de Oliveira, Cleyton Zanardo; Nascimento, Maria Salete de Angelis; Paiva, Carlos Eduardo

2017-08-23

The aim of this study was to assess the feasibility and potential benefit of a brief psychosocial intervention based on cognitive-behavioral therapy performed in addition to early palliative care (PC) in the reduction of depressive symptoms among patients with advanced cancer. An open-label randomized phase II clinical trial with two intervention arms and one control group. Patients with advanced cancer starting palliative chemotherapy and who met the selection criteria were included. The participants were randomly allocated to three arms: arm A, five weekly sessions of psychosocial intervention combined with early PC; arm B, early PC only; and arm C, standard cancer treatment. Feasibility was investigated by calculating rates (%) of inclusion, attrition, and contamination (% of patients from Arm C that received PC). Scores of depression (primary aim), anxiety, and quality of life were measured at baseline and 45, 90, 120, and 180 days after randomization. From the total of 613 screened patients (10.3% inclusion rate), 19, 22, and 22 patients were allocated to arms A, B, and C, respectively. Contamination and attrition rates (180 days) were 31.8% and 38.0%, respectively. No interaction between the arms and treatments were found. Regarding effect sizes, there was a moderate benefit in arm A over arms B and C in emotional functioning (-0.66 and -0.61, respectively) but a negative effect of arm A over arm C in depression (-0.74). Future studies to be conducted with this population group need to revise the eligibility criteria and make them less restrictive. In addition, the need for arm C is questioned due to high contamination rate. The designed psychosocial intervention was not able to reduce depressive symptoms when combined with early PC. Further studies are warrant to evaluate the intervention on-demand and in subgroups of high risk of anxiety/depression. Clinical Trials identifier NCT02133274 . Registered May 6, 2014.

Combined Cognitive-Motor Rehabilitation in Virtual Reality Improves Motor Outcomes in Chronic Stroke - A Pilot Study.

PubMed

Faria, Ana L; Cameirão, Mónica S; Couras, Joana F; Aguiar, Joana R O; Costa, Gabriel M; Bermúdez I Badia, Sergi

2018-01-01

Stroke is one of the most common causes of acquired disability, leaving numerous adults with cognitive and motor impairments, and affecting patients' capability to live independently. Virtual Reality (VR) based methods for stroke rehabilitation have mainly focused on motor rehabilitation but there is increasing interest toward the integration of cognitive training for providing more effective solutions. Here we investigate the feasibility for stroke recovery of a virtual cognitive-motor task, the Reh@Task, which combines adapted arm reaching, and attention and memory training. 24 participants in the chronic stage of stroke, with cognitive and motor deficits, were allocated to one of two groups (VR, Control). Both groups were enrolled in conventional occupational therapy, which mostly involves motor training. Additionally, the VR group underwent training with the Reh@Task and the control group performed time-matched conventional occupational therapy. Motor and cognitive competences were assessed at baseline, end of treatment (1 month) and at a 1-month follow-up through the Montreal Cognitive Assessment, Single Letter Cancelation, Digit Cancelation, Bells Test, Fugl-Meyer Assessment Test, Chedoke Arm and Hand Activity Inventory, Modified Ashworth Scale, and Barthel Index. Our results show that both groups improved in motor function over time, but the Reh@Task group displayed significantly higher between-group outcomes in the arm subpart of the Fugl-Meyer Assessment Test. Improvements in cognitive function were significant and similar in both groups. Overall, these results are supportive of the viability of VR tools that combine motor and cognitive training, such as the Reh@Task. Trial Registration: This trial was not registered because it is a small clinical study that addresses the feasibility of a prototype device.

Combined Cognitive-Motor Rehabilitation in Virtual Reality Improves Motor Outcomes in Chronic Stroke – A Pilot Study

PubMed Central

Faria, Ana L.; Cameirão, Mónica S.; Couras, Joana F.; Aguiar, Joana R. O.; Costa, Gabriel M.; Bermúdez i Badia, Sergi

2018-01-01

Stroke is one of the most common causes of acquired disability, leaving numerous adults with cognitive and motor impairments, and affecting patients’ capability to live independently. Virtual Reality (VR) based methods for stroke rehabilitation have mainly focused on motor rehabilitation but there is increasing interest toward the integration of cognitive training for providing more effective solutions. Here we investigate the feasibility for stroke recovery of a virtual cognitive-motor task, the Reh@Task, which combines adapted arm reaching, and attention and memory training. 24 participants in the chronic stage of stroke, with cognitive and motor deficits, were allocated to one of two groups (VR, Control). Both groups were enrolled in conventional occupational therapy, which mostly involves motor training. Additionally, the VR group underwent training with the Reh@Task and the control group performed time-matched conventional occupational therapy. Motor and cognitive competences were assessed at baseline, end of treatment (1 month) and at a 1-month follow-up through the Montreal Cognitive Assessment, Single Letter Cancelation, Digit Cancelation, Bells Test, Fugl-Meyer Assessment Test, Chedoke Arm and Hand Activity Inventory, Modified Ashworth Scale, and Barthel Index. Our results show that both groups improved in motor function over time, but the Reh@Task group displayed significantly higher between-group outcomes in the arm subpart of the Fugl-Meyer Assessment Test. Improvements in cognitive function were significant and similar in both groups. Overall, these results are supportive of the viability of VR tools that combine motor and cognitive training, such as the Reh@Task. Trial Registration: This trial was not registered because it is a small clinical study that addresses the feasibility of a prototype device. PMID:29899719

Defense.gov - Congressional Gold Medal Presentation: Women Airforce Service

Science.gov Websites

, received the Congressional Gold Medal at a ceremony in the Capitol. Story Female World War II Pilots World War II Women Airforce Service Pilot corps remembered their sisters-in-arms during a wreath-laying homage to the achievements of the first women to fly military aircraft during World War II. Story Women

Simulation Study of Impact of Aeroelastic Characteristics on Flying Qualities of a High Speed Civil Transport

NASA Technical Reports Server (NTRS)

Raney, David L.; Jackson, E. Bruce; Buttrill, Carey S.

2002-01-01

A piloted simulation study conducted in NASA Langley Visual Motion Simulator addressed the impact of dynamic aero- servoelastic effects on flying qualities of a High Speed Civil Transport. The intent was to determine effectiveness of measures to reduce the impact of aircraft flexibility on piloting tasks. Potential solutions examined were increasing frequency of elastic modes through structural stiffening, increasing damping of elastic modes through active control, elimination of control effector excitation of the lowest frequency elastic modes, and elimination of visual cues associated with elastic modes. Six test pilots evaluated and performed simulated maneuver tasks, encountering incidents wherein cockpit vibrations due to elastic modes fed back into the control stick through involuntary vibrations of the pilots upper body and arm. Structural stiffening and compensation of the visual display were of little benefit in alleviating this impact, while increased damping and elimination of control effector excitation of the elastic modes both offered great improvements when applied in sufficient degree.

Mean diffusivity as a potential diffusion tensor biomarker of motor rehabilitation after electrical stimulation incorporating task specific exercise in stroke: a pilot study.

PubMed

Boespflug, Erin L; Storrs, Judd M; Allendorfer, Jane B; Lamy, Martine; Eliassen, James C; Page, Stephen

2014-09-01

Changes in diffusion tensor imaging (DTI) values co-occur with neurological and functional changes after stroke. However, quantitative DTI metrics have not been examined in response to participation in targeted rehabilitative interventions in chronic stroke. The primary purpose of this pilot study was to examine whether changes in DTI metrics co-occur with paretic arm movement changes among chronic stroke patients participating in a regimen of electrical stimulation targeting the paretic arm. Three subjects exhibiting stable arm hemiparesis were administered 30-minute (n = 1) or 120-minute (n = 2) therapy sessions emphasizing paretic arm use during valued, functional tasks and incorporating an electrical stimulation device. These sessions occurred every weekday for 8 weeks. A fourth subject served as a treatment control, participating in a 30-minute home exercise regimen without electrical stimulation every weekday for 8 weeks. DTI and behavioral outcome measures were acquired at baseline and after intervention. DTI data were analyzed using a region of interest (ROI) approach, with ROIs chosen based on tract involvement in sensorimotor function or as control regions. Behavioral outcome measures were the Fugl-Meyer Scale (FM) and the Action Research Arm Test (ARAT). The treatment control subject exhibited gains in pinch and grasp, as shown by a 5-point increase on the ARAT. The subject who participated in 30-minute therapy sessions exhibited no behavioral gains. Subjects participating in 120-minute therapy sessions displayed consistent impairment reductions and distal movement changes. DTI changes were largest in subjects two and three, with mean diffusivity (MD) decreases in the middle cerebellar peduncle and posterior limb of the internal capsule following treatment. No changes in fractional anisotropy (FA) were observed for sensorimotor tracts. Our preliminary results suggest that active rehabilitative therapies augmented by electrical stimulation may induce positive behavioral changes which are underscored by DTI changes indicative of increased white matter tract integrity in regions specific to sensory-motor function.

Korean Air Lines Flight 007: Lessons from the Past and Insights for the Future

NASA Technical Reports Server (NTRS)

Degani, Asaf; Shafto, M. (Technical Monitor)

2001-01-01

The majority of the problems pilot encounter when using automated systems center around two factors: (1) the pilot has an incomplete and inadequate model of how the autopilot works; and (2) the displays and flight manuals, provided to the pilot, are inadequate for the task. The tragic accident of Korean Air Lines Flight 007, a Boeing 747 that deviated from its intended flight path, provides a compelling case-study of problems related to pilots' use of automated systems. This paper describes what had happened and exposes two types of human-automation interaction problems: (1) The pilots of KAL were not provided with adequate information about the actual behavior of the autopilot and its mode transition logic; and (2) The autopilot onboard KAL 007 did not provide adequate information to the flight crew about its active and armed modes. Both factors, according to the International Civil Aviation Organization (1993) report on the accident, contributed to the aircraft's lethal navigation error.

Advanced helicopter cockpit and control configurations for helicopter combat missions

NASA Technical Reports Server (NTRS)

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

1987-01-01

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

Automating arm movement training following severe stroke: functional exercises with quantitative feedback in a gravity-reduced environment.

PubMed

Sanchez, Robert J; Liu, Jiayin; Rao, Sandhya; Shah, Punit; Smith, Robert; Rahman, Tariq; Cramer, Steven C; Bobrow, James E; Reinkensmeyer, David J

2006-09-01

An important goal in rehabilitation engineering is to develop technology that allows individuals with severe motor impairment to practice arm movement without continuous supervision from a rehabilitation therapist. This paper describes the development of such a system, called Therapy WREX or ("T-WREX"). The system consists of an orthosis that assists in arm movement across a large workspace, a grip sensor that detects hand grip pressure, and software that simulates functional activities. The arm orthosis is an instrumented, adult-sized version of the Wilmington Robotic Exoskeleton (WREX), which is a five degrees-of-freedom mechanism that passively counterbalances the weight of the arm using elastic bands. After providing a detailed design description of T-WREX, this paper describes two pilot studies of the system's capabilities. The first study demonstrated that individuals with chronic stroke whose arm function is compromised in a normal gravity environment can perform reaching and drawing movements while using T-WREX. The second study demonstrated that exercising the affected arm of five people with chronic stroke with T-WREX over an eight week period improved unassisted movement ability (mean change in Fugl-Meyer score was 5 points +/- 2 SD; mean change in range of motion of reaching was 10%, p < 0.001). These results demonstrate the feasibility of automating upper-extremity rehabilitation therapy for people with severe stroke using passive gravity assistance, a grip sensor, and simple virtual reality software.

In Vivo Orientation of Single Myosin Lever Arms in Zebrafish Skeletal Muscle

PubMed Central

Sun, Xiaojing; Ekker, Stephen C.; Shelden, Eric A.; Takubo, Naoko; Wang, Yihua; Burghardt, Thomas P.

2014-01-01

Cardiac and skeletal myosin assembled in the muscle lattice power contraction by transducing ATP free energy into the mechanical work of moving actin. Myosin catalytic/lever-arm domains comprise the transduction/mechanical coupling machinery that move actin by lever-arm rotation. In vivo, myosin is crowded and constrained by the fiber lattice as side chains are mutated and otherwise modified under normal, diseased, or aging conditions that collectively define the native myosin environment. Single-myosin detection uniquely defines bottom-up characterization of myosin functionality. The marriage of in vivo and single-myosin detection to study zebrafish embryo models of human muscle disease is a multiscaled technology that allows one-to-one registration of a selected myosin molecular alteration with muscle filament-sarcomere-cell-fiber-tissue-organ- and organism level phenotypes. In vivo single-myosin lever-arm orientation was observed at superresolution using a photoactivatable-green-fluorescent-protein (PAGFP)-tagged myosin light chain expressed in zebrafish skeletal muscle. By simultaneous observation of multiphoton excitation fluorescence emission and second harmonic generation from myosin, we demonstrated tag specificity for the lever arm. Single-molecule detection used highly inclined parallel beam illumination and was verified by quantized photoactivation and photobleaching. Single-molecule emission patterns from relaxed muscle in vivo provided extensive superresolved dipole orientation constraints that were modeled using docking scenarios generated for the myosin (S1) and GFP crystal structures. The dipole orientation data provided sufficient constraints to estimate S1/GFP coordination. The S1/GFP coordination in vivo is rigid and the lever-arm orientation distribution is well-ordered in relaxed muscle. For comparison, single myosins in relaxed permeabilized porcine papillary muscle fibers indicated slightly differently oriented lever arms and rigid S1/GFP coordination. Lever arms in both muscles indicated one preferred spherical polar orientation and widely distributed azimuthal orientations relative to the fiber symmetry axis. Cardiac myosin is more radially displaced from the fiber axis. Probe rigidity implies the PAGFP tag reliably indicates cross-bridge orientation in situ and in vivo. PMID:25229148

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

Gustafson, William I.; Vogelmann, Andrew M.; Cheng, Xiaoping

The Department of Energy (DOE) Atmospheric Radiation Measurement (ARM) Climate Research Facility began a pilot project in May 2015 to design a routine, high-resolution modeling capability to complement ARM’s extensive suite of measurements. This modeling capability has been named the Large-Eddy Simulation (LES) ARM Symbiotic Simulation and Observation (LASSO) project. The initial focus of LASSO is on shallow convection at the ARM Southern Great Plains (SGP) Climate Research Facility. The availability of LES simulations with concurrent observations will serve many purposes. LES helps bridge the scale gap between DOE ARM observations and models, and the use of routine LES addsmore » value to observations. It provides a self-consistent representation of the atmosphere and a dynamical context for the observations. Further, it elucidates unobservable processes and properties. LASSO will generate a simulation library for researchers that enables statistical approaches beyond a single-case mentality. It will also provide tools necessary for modelers to reproduce the LES and conduct their own sensitivity experiments. Many different uses are envisioned for the combined LASSO LES and observational library. For an observationalist, LASSO can help inform instrument remote sensing retrievals, conduct Observation System Simulation Experiments (OSSEs), and test implications of radar scan strategies or flight paths. For a theoretician, LASSO will help calculate estimates of fluxes and co-variability of values, and test relationships without having to run the model yourself. For a modeler, LASSO will help one know ahead of time which days have good forcing, have co-registered observations at high-resolution scales, and have simulation inputs and corresponding outputs to test parameterizations. Further details on the overall LASSO project are available at https://www.arm.gov/capabilities/modeling/lasso.« less

Primary reaction control system/remote manipulator system interaction with loaded arm. Space shuttle engineering and operations support

NASA Technical Reports Server (NTRS)

Taylor, E. C.; Davis, J. D.

1978-01-01

A study of the interaction between the orbiter primary reaction control system (PRCS) and the remote manipulator system (RMS) with a loaded arm is documented. This analysis was performed with the Payload Deployment and Retrieval Systems Simulation (PDRSS) program with the passive arm bending option. The passive-arm model simulates the arm as massless elastic links with locked joints. The study was divided into two parts. The first part was the evaluation of the response of the arm to step inputs (i.e. constant jet torques) about each of the orbiter body axes. The second part of the study was the evaluation of the response of the arm to minimum impulse primary RCS jet firings with both single pulse and pulse train inputs.

Self-Administered, Home-Based SMART (Sensorimotor Active Rehabilitation Training) Arm Training: A Single-Case Report.

PubMed

Hayward, Kathryn S; Neibling, Bridee A; Barker, Ruth N

2015-01-01

This single-case, mixed-method study explored the feasibility of self-administered, home-based SMART (sensorimotor active rehabilitation training) Arm training for a 57-yr-old man with severe upper-limb disability after a right frontoparietal hemorrhagic stroke 9 mo earlier. Over 4 wk of self-administered, home-based SMART Arm training, the participant completed 2,100 repetitions unassisted. His wife provided support for equipment set-up and training progressions. Clinically meaningful improvements in arm impairment (strength), activity (arm and hand tasks), and participation (use of arm in everyday tasks) occurred after training (at 4 wk) and at follow-up (at 16 wk). Areas for refinement of SMART Arm training derived from thematic analysis of the participant's and researchers' journals focused on enabling independence, ensuring home and user friendliness, maintaining the motivation to persevere, progressing toward everyday tasks, and integrating practice into daily routine. These findings suggest that further investigation of self-administered, home-based SMART Arm training is warranted for people with stroke who have severe upper-limb disability. Copyright © 2015 by the American Occupational Therapy Association, Inc.

My Team of Care Study: A Pilot Randomized Controlled Trial of a Web-Based Communication Tool for Collaborative Care in Patients With Advanced Cancer.

PubMed

Voruganti, Teja; Grunfeld, Eva; Jamieson, Trevor; Kurahashi, Allison M; Lokuge, Bhadra; Krzyzanowska, Monika K; Mamdani, Muhammad; Moineddin, Rahim; Husain, Amna

2017-07-18

The management of patients with complex care needs requires the expertise of health care providers from multiple settings and specialties. As such, there is a need for cross-setting, cross-disciplinary solutions that address deficits in communication and continuity of care. We have developed a Web-based tool for clinical collaboration, called Loop, which assembles the patient and care team in a virtual space for the purpose of facilitating communication around care management. The objectives of this pilot study were to evaluate the feasibility of integrating a tool like Loop into current care practices and to capture preliminary measures of the effect of Loop on continuity of care, quality of care, symptom distress, and health care utilization. We conducted an open-label pilot cluster randomized controlled trial allocating patients with advanced cancer (defined as stage III or IV disease) with ≥3 months prognosis, their participating health care team and caregivers to receive either the Loop intervention or usual care. Outcome data were collected from patients on a monthly basis for 3 months. Trial feasibility was measured with rate of uptake, as well as recruitment and system usage. The Picker Continuity of Care subscale, Palliative care Outcomes Scale, Edmonton Symptom Assessment Scale, and Ambulatory and Home Care Record were patient self-reported measures of continuity of care, quality of care, symptom distress, and health services utilization, respectively. We conducted a content analysis of messages posted on Loop to understand how the system was used. Nineteen physicians (oncologists or palliative care physicians) were randomized to the intervention or control arms. One hundred twenty-seven of their patients with advanced cancer were approached and 48 patients enrolled. Of 24 patients in the intervention arm, 20 (83.3%) registered onto Loop. In the intervention and control arms, 12 and 11 patients completed three months of follow-up, respectively. A mean of 1.2 (range: 0 to 4) additional healthcare providers with an average total of 3 healthcare providers participated per team. An unadjusted between-arm increase of +11.4 was observed on the Picker scale in favor of the intervention arm. Other measures showed negligible changes. Loop was primarily used for medical care management, symptom reporting, and appointment coordination. The results of this study show that implementation of Loop was feasible. It provides useful information for planning future studies further examining effectiveness and team collaboration. Numerically higher scores were observed for the Loop arm relative to the control arm with respect to continuity of care. Future work is required to understand the incentives and barriers to participation so that the implementation of tools like Loop can be optimized. ClinicalTrials.gov NCT02372994; https://clinicaltrials.gov/ct2/show/NCT02372994 (Archived by WebCite at http://www.webcitation.org/6r00L4Skb). ©Teja Voruganti, Eva Grunfeld, Trevor Jamieson, Allison M Kurahashi, Bhadra Lokuge, Monika K Krzyzanowska, Muhammad Mamdani, Rahim Moineddin, Amna Husain. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 18.07.2017.

Reinforcement of adherence to prescription recommendations in Asian Indian diabetes patients using short message service (SMS)--a pilot study.

PubMed

Shetty, Ananth Samith; Chamukuttan, Snehalatha; Nanditha, Arun; Raj, Roopesh Kumar Champat; Ramachandran, Ambady

2011-11-01

To investigate the acceptability and feasibility of using short message services (SMS) via cell phones to ensure adherence to management prescriptions by diabetic patients. Type 2 diabetic patients with 5 or more years of diabetes and having HbA1c between 7.0% to 10% were randomized to the control arm (n = 105) to receive standard care and to the intervention arm (SMS, n = 110). Messages in English on principles of diabetes management were sent once in 3 days, the contents and frequencies varied as per the patients' preferences. The study duration was 1 year. All participants were advised to report for quarterly clinic visits. A comparative assessment of the clinical, biochemical and anthropometric outcomes was made among the groups at the annual visit. Annual review was possible in 71% of intervention group and 63% of control group. SMS was acceptable to the patients and the median number requested was 2 per week. HbA1c and plasma lipids improved significantly in the SMS group. The pilot study showed that frequent communication via SMS was acceptable to diabetic patients and it helped to improve the health outcomes.

Short-term additional enfuvirtide therapy is associated with a greater immunological recovery in HIV very late presenters: a controlled pilot study.

PubMed

Bonora, S; Calcagno, A; Cometto, C; Fontana, S; Aguilar, D; D'Avolio, A; Gonzalez de Requena, D; Maiello, A; Dal Conte, I; Lucchini, A; Di Perri, G

2012-02-01

To evaluate whether the addition of enfuvirtide to standard highly active antiretroviral therapy (HAART) could confer immunovirological benefits in human immunodeficiency virus (HIV)-infected very late presenters. The current study is an open comparative therapeutic trial of standard protease inhibitor (PI)-based HAART ± additional enfuvirtide in treatment-naïve deeply immunologically impaired HIV-positive patients. Very late presenters (CD4 <50/mm(3)), without tuberculosis and neoplasms, were alternatively allocated to two nucleoside reverse transcriptase inhibitors (NRTIs) and lopinavir/ritonavir without (control arm, CO) or with (ENF arm) enfuvirtide 90 mg bid. Enfuvirtide was administered until the achievement of viral load <50 copies/ml and for at least 24 weeks. The primary objective was the magnitude of CD4+ cell recovery at 6 months. HIV RNA was intensively monitored in the first month, and, thereafter, monthly, as for CD4+ cell count and percentage, clinical data, and plasma drug concentrations. Of 22 enrolled patients (11 per arm), 19 completed the study (10 in the ENF arm). Baseline CD4+ cell counts and % were comparable, with 20 CD4+/mm(3) (12-37) and a percentage of 3.3 (1.7-7.1) in the ENF arm, and 16 CD4+/mm(3) (9-29) and a percentage of 3.1 (2.3-3.8) in the CO arm, respectively. The baseline viral load was also comparable between the two arms, with 5.77 log10 (5.42-6) and 5.39 log10 (5.06-6) in the ENF and CO arms, respectively. Enfuvirtide recipients had higher CD4+ percentage at week 8 (7.6 vs. 3.6%, p = 0.02) and at week 24 (10.7 vs. 5.9%, p = 0.02), and a greater CD4+ increase at week 24 (207 vs. 134 cells/mm(3), p = 0.04), with 70% of enfuvirtide intakers versus 12.5% of controls who achieved a CD4+ cell count >200/mm(3) (p = 0.01). At 48 weeks, patients in the ENF arm had CD4+ cell counts higher than controls (251 vs. 153cells/mm(3), p = 0.04) and were also found to be faster in reaching a CD4 cell count over 200/mm(3): 18 (8-24) versus 48 (36-108) weeks (p = 0.01). Viral load decay at week 4 was greater in the ENF arm (-3 vs. -2.2 log, p = 0.04), while the proportion of patients with viral load <50 copies/ml at week 24 was comparable. In this pilot study, the addition of enfuvirtide to a lopinavir-based HAART was shown to be associated with a significantly faster and greater immunological recovery in newly discovered HIV-positive patients with very low CD4+ cell counts. Induction strategies using an enfuvirtide-based approach in such subjects warrant further investigation.

A pilot study of activity-based therapy in the arm motor recovery post stroke: a randomized controlled trial.

PubMed

Rabadi, Mh; Galgano, M; Lynch, D; Akerman, M; Lesser, M; Volpe, Bt

2008-12-01

To determine the efficacy of activity-based therapies using arm ergometer or robotic or group occupational therapy for motor recovery of the paretic arm in patients with an acute stroke (< or =4 weeks) admitted to an inpatient rehabilitation facility, and to obtain information to plan a large randomized controlled trial. Prospective, randomized controlled study. Stroke unit in a rehabilitation hospital. Thirty patients with an acute stroke (< or =4 weeks) who had arm weakness (Medical Research Council grade 2 or less at the shoulder joint). Occupational therapy (OT) group (control) (n = 10), arm ergometer (n = 10) or robotic (n = 10) therapy group. All patients received standard, inpatient, post-stroke rehabilitation training for 3 hours a day, plus 12 additional 40-minute sessions of the activity-based therapy. The primary outcome measures were discharge scores in the Fugl-Meyer Assessment Scale for upper limb impairment, Motor Status Scale, total Functional Independence Measure (FIM) and FIM-motor and FIM-cognition subscores. The three groups (OT group versus arm ergometer versus robotic) were comparable on clinical demographic measures except the robotic group was significantly older and there were more haemorrhagic stroke patients in the arm ergometer group. After adjusting for age, stroke type and outcome measures at baseline, a similar degree of improvement in the discharge scores was found in all of the primary outcome measures. This study suggests that activity-based therapies using an arm ergometer or robot when used over shortened training periods have the same effect as OT group therapy in decreasing impairment and improving disability in the paretic arm of severely affected stroke patients in the subacute phase.

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

PubMed

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

2017-01-01

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

Pilot study to test effectiveness of video game on reaching performance in stroke.

PubMed

Acosta, Ana Maria; Dewald, Hendrik A; Dewald, Jules P A

2011-01-01

Robotic systems currently used in upper-limb rehabilitation following stroke rely on some form of visual feedback as part of the intervention program. We evaluated the effect of a video game environment (air hockey) on reaching in stroke with various levels of arm support. We used the Arm Coordination Training 3D system to provide variable arm support and to control the hockey stick. We instructed seven subjects to reach to one of three targets covering the workspace of the impaired arm during the reaching task and to reach as far as possible while playing the video game. The results from this study showed that across subjects, support levels, and targets, the reaching distances achieved with the reaching task were greater than those covered with the video game. This held even after further restricting the mapped workspace of the arm to the area most affected by the flexion synergy (effectively forcing subjects to fight the synergy to reach the hockey puck). The results from this study highlight the importance of designing video games that include specific reaching targets in the workspace compromised by the expression of the flexion synergy. Such video games would also adapt the target location online as a subject's success rate increases.

Pilot study to test effectiveness of video game on reaching performance in stroke

PubMed Central

Acosta, Ana Maria; Dewald, Hendrik A.; Dewald, Jules P. A.

2012-01-01

Robotic systems currently used in upper-limb rehabilitation following stroke rely on some form of visual feedback as part of the intervention program. We evaluated the effect of a video game environment (air hockey) on reaching in stroke with various levels of arm support. We used the Arm Coordination Training 3D system to provide variable arm support and to control the hockey stick. We instructed seven subjects to reach to one of three targets covering the workspace of the impaired arm during the reaching task and to reach as far as possible while playing the video game. The results from this study showed that across subjects, support levels, and targets, the reaching distances achieved with the reaching task were greater than those covered with the video game. This held even after further restricting the mapped workspace of the arm to the area most affected by the flexion synergy (effectively forcing subjects to fight the synergy to reach the hockey puck). The results from this study highlight the importance of designing video games that include specific reaching targets in the workspace compromised by the expression of the flexion synergy. Such video games would also adapt the target location online as a subject’s success rate increases. PMID:21674392

Exclusive breast-feeding promotion among HIV-infected women in South Africa: an Information-Motivation-Behavioural Skills model-based pilot intervention.

PubMed

Tuthill, Emily L; Butler, Lisa M; Pellowski, Jennifer A; McGrath, Jacqueline M; Cusson, Regina M; Gable, Robert K; Fisher, Jeffrey D

2017-06-01

Exclusive breast-feeding (EBF) provides optimal nutrition for infants and mothers. The practice of EBF while adhering to antiretroviral medication decreases the risk of mother-to-child transmission of HIV from approximately 25 % to less than 5 %. Thus the WHO recommends EBF for the first 6 months among HIV-infected women living in resource-limited settings; however, EBF rates remain low. In the present study our aim was to design and implement a pilot intervention promoting EBF among HIV-infected women. The Information-Motivation-Behavioural Skills (IMB) model was applied in a brief motivational interviewing counselling session that was tested in a small randomized controlled trial. Pietermaritzburg, South Africa, at two comparable rural public health service clinics. Sixty-eight HIV-infected women in their third trimester were enrolled and completed baseline interviews between June and August 2014. Those randomized to the intervention arm received the IMB-based pilot intervention directly following baseline interviews. Follow-up interviews occurred at 6 weeks postpartum. While not significantly different between trial arms, high rates of intention and practice of EBF at 6-week follow-up were reported. Findings showed high levels of self-efficacy being significantly predictive of breast-feeding initiation and duration regardless of intervention arm. Future research must account for breast-feeding self-efficacy on sustaining breast-feeding behaviour and leverage strategies to enhance self-efficacy in supportive interventions. Supporting breast-feeding behaviour through programmes that include both individual-level and multi-systems components targeting the role of health-care providers, family and community may create environments that value and support EBF behaviour.

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

Design and Implementation of a Physician Coaching Pilot to Promote Value-Based Referrals to Specialty Care.

PubMed

Tuzzio, Leah; Ludman, Evette J; Chang, Eva; Palazzo, Lorella; Abbott, Travis; Wagner, Edward H; Reid, Robert J

2017-01-01

Referral rates to specialty care from primary care physicians vary widely. To address this variability, we developed and pilot tested a peer-to-peer coaching program for primary care physicians. To assess the feasibility and acceptability of the coaching program, which gave physicians access to their individual-level referral data, strategies, and a forum to discuss referral decisions. The team designed the program using physician input and a synthesis of the literature on the determinants of referral. We conducted a single-arm observational pilot with eight physicians which made up four dyads, and conducted a qualitative evaluation. Primary reasons for making referrals were clinical uncertainty and patient request. Physicians perceived doctor-to-doctor dialogue enabled mutual learning and a pathway to return joy to the practice of primary care medicine. The program helped physicians become aware of their own referral data, reasons for making referrals, and new strategies to use in their practice. Time constraints caused by large workloads were cited as a barrier both to participating in the pilot and to practicing in ways that optimize referrals. Physicians reported that the program could be sustained and spread if time for mentoring conversations was provided and/or nonfinancial incentives or compensation was offered. This physician mentoring program aimed at reducing specialty referral rates is feasible and acceptable in primary care settings. Increasing the appropriateness of referrals has the potential to provide patient-centered care, reduce costs for the system, and improve physician satisfaction.

Individuals with chronic hemiparetic stroke can correctly match forearm positions within a single arm

PubMed Central

Gurari, Netta; Drogos, Justin M.; Dewald, Julius P.A.

2017-01-01

Objective Previous studies determined, using between arms position matching assessments, that at least one-half of individuals with stroke have an impaired position sense. We investigated whether individuals with chronic stroke who have impairments mirroring arm positions also have impairments identifying the location of each arm in space. Methods Participants with chronic hemiparetic stroke and age-matched participants without neurological impairments (controls) performed a between forearms position matching task based on a clinical assessment and a single forearm position matching task, using passive and active movements, based on a robotic assessment. Results 12 out of our 14 participants with stroke who had clinically determined between forearms position matching impairments had greater errors than the controls in both their paretic and non-paretic arm when matching positions during passive movements; yet stroke participants performed comparable to the controls during active movements. Conclusions Many individuals with chronic stroke may have impairments matching positions in both their paretic and non-paretic arm if their arm is moved for them, yet not within either arm if these individuals control their own movements. Significance The neural mechanisms governing arm location perception in the stroke population may differ depending on whether arm movements are made passively versus actively. PMID:27866116

A prospective, multicenter pilot study to investigate the feasibility and safety of a 1-year controlled exercise training after adjuvant chemotherapy in colorectal cancer patients.

PubMed

Piringer, Gudrun; Fridrik, Michael; Fridrik, Alfred; Leiherer, Andreas; Zabernigg, August; Greil, Richard; Eisterer, Wolfgang; Tschmelitsch, Jörg; Lang, Alois; Frantal, Sophie; Burgstaller, Sonja; Gnant, Michael; Thaler, Josef

2018-04-01

Despite advances in adjuvant chemotherapy, 20-30% of patients in stages II-III colorectal cancer will eventually relapse. Observational studies showed a reduction in relapse rate, colon cancer-specific mortality, and overall mortality by physical activity. Results from prospective randomized interventional studies to confirm these observational data are lacking. The aims of this prospective single-arm multicenter pilot study are to evaluate feasibility and safety of exercise training after adjuvant chemotherapy in colorectal cancer patients. The training was performed three times per week for 1 year and was increased gradually in three phases until reaching 18 metabolic equivalent task hours per week. Overall, 30 patients were included. The planned training intensity could be achieved in all three phases. Patients experienced a performance increase of median 35.5 watt, a weight-loss of a median of 3.0 kg, and a reduction in body fat content of median 1.0% during this exercise training. The analysis showed early study termination due to non-compliance in 10/30 patients (33.3%), disease progression in 4 patients (13.3%), and serious adverse events in 2 patients (6.7%). About half of patients (46.7%) completed the pilot study as planned. Biomarker analysis from 20 patients showed a non-significant reduction in insulin-like growth factor 1 (IGF-1), insulin-like growth factor 2 (IGF-2) and insulin-like growth factor binding protein 3 (IGF-BP3) levels, significant increases in adiponectin and leptin levels, and a non-significant increase in C-peptide levels. Exercise training is feasible in patients with colorectal cancer after completion of adjuvant chemotherapy. The main problem encountered during the study was compliance. To improve compliance of exercise training, several measures were adapted for the upcoming prospective randomized ABCSG C08 Exercise II study.

A pilot randomised trial to assess the methods and procedures for evaluating the clinical effectiveness and cost-effectiveness of Exercise Assisted Reduction then Stop (EARS) among disadvantaged smokers.

PubMed

Taylor, Adrian H; Thompson, Tom P; Greaves, Colin J; Taylor, Rod S; Green, Colin; Warren, Fiona C; Kandiyali, Rebecca; Aveyard, Paul; Ayres, Richard; Byng, Richard; Campbell, John L; Ussher, Michael H; Michie, Susan; West, Robert

2014-01-01

There have been few rigorous studies on the effects of behavioural support for helping smokers to reduce who do not immediately wish to quit. While reduction may not have the health benefits of quitting, it may lead smokers to want to quit. Physical activity (PA) helps to reduce cravings and withdrawal symptoms, and also reduces weight gain after quitting, but smokers may be less inclined to exercise. There is scope to develop and determine the effectiveness of interventions to support smoking reduction and increase physical activity, for those not ready to quit. To conduct a pilot randomised controlled trial (RCT) [Exercise Assisted Reduction then Stop (EARS) smoking study] to (1) design and evaluate the feasibility and acceptability of a PA and smoking-reduction counselling intervention [for disadvantaged smokers who do not wish to quit but do want to reduce their smoking (to increase the likelihood of quitting)], and (2) to inform the design of a large RCT to determine the clinical effectiveness and cost-effectiveness of the intervention. A single-centre, pragmatic, pilot trial with follow-up up to 16 weeks. A mixed methods approach assessed the acceptability and feasibility of the intervention and trial methods. Smokers were individually randomised to intervention or control arms. General practices, NHS buildings, community venues, and the Stop Smoking Service (SSS) within Plymouth, UK. Aged > 18 years, smoking ≥ 10 cigarettes per day (for ≥ 2 years) who wished to cut down. We excluded individuals who were contraindicated for moderate PA, posed a safety risk to the research team, wished to quit immediately or use Nicotine Replacement Therapy, not registered with a general practitioner, or did not converse in English. We designed a client-centred, counselling-based intervention designed to support smoking reduction and increases in PA. Support sessions were delivered by trained counsellors either face to face or by telephone. Both intervention and control arms were given information at baseline on specialist SSS support available should they have wished to quit. The primary outcome was 4-week post-quit expired air carbon monoxide (CO)-confirmed abstinence from smoking. Secondary outcomes included validated behavioural, cognitive and emotional/affective and health-related quality of life measures and treatment costs. The study randomised 99 participants, 49 to the intervention arm and 50 to the control arm, with a 62% follow-up rate at 16 weeks. In the intervention and control arms, 14% versus 4%, respectively [relative risk = 3.57; 95% confidence interval (CI) 0.78 to 16.35], had expired CO-confirmed abstinence at least 4 and up to 8 weeks after quit day; 22% versus 6% (relative risk = 3.74; 95% CI 1.11 to 12.60) made a quit attempt; 10% versus 4% (relative risk = 92.55; 95% CI 0.52 to 12.53) achieved point-prevalent abstinence at 16 weeks; and 39% versus 20% (relative risk = 1.94; 95% CI 1.01 to 3.74) achieved at least a 50% reduction in the number of cigarettes smoked daily. The percentage reporting using PA for controlling smoking in the intervention versus control arms was 55% versus 22%, respectively at 8 weeks and 37% versus 16%, respectively, at 16 weeks. The counsellors generally delivered the intervention as planned and participants responded with a variety of smoking reduction strategies, sometimes supported by changes in PA. The intervention costs were approximately £192 per participant. Exploratory cost-effectiveness modelling indicates that the intervention may be cost-effective. The study provided valuable information on the resources needed to improve study recruitment and retention. Offering support for smoking reduction and PA appears to have value in promoting reduction and cessation in disadvantaged smokers not currently motivated to quit. A large RCT is needed to assess the clinical effectiveness and cost-effectiveness of the intervention in this population. ISRCTN 13837944. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment, Vol. 18, No. 4. See the NIHR Journals Library website for further project information.

Cost analysis of cetuximab (Erbitux) plus radiotherapy (ERT) versus concomitant cisplatin plus radiotherapy (CRT) within an NHS oncology unit (single institution): a pilot study.

PubMed

Caroline, Brammer; Sundus, Yahya; Dawn, Dawson; Carol, Glaister; Susan, Merrick

2016-12-01

The aim of this feasibility study is to define the resource effectiveness of cetuximab vs cisplatin given concomitantly with radiotherapy for squamous cell carcinoma within a National Health Service clinical oncology unit. 20 patients with Stage 3 or 4 head and neck squamous cell cancers were randomized to receive either cetuximab with radiotherapy (ERT) or cisplatin with radiotherapy concurrent with external beam radiotherapy 70 Gy in 35 fractions on a 1 : 1 basis over a 12-month duration. The study compared the resource utilization of ERT vs cisplatin with radiotherapy taking into account drug costs, clinical management and the costs of managing treatment-related toxicity from first fraction of radiotherapy to 6 months after the completion of therapy. Outcome measures were quality of life (recorded at the entry, end of radiotherapy, 6 weeks post treatment and 6 months post treatment), admissions to hospital, delays to radiotherapy, locoregional control and survival. Total drug costs including cost of nutritional supplements for patients treated with cetuximab were £7407.45 compared with £3959.07 for patients treated with cisplatin. Unscheduled admissions for toxicity management were significantly more common in the ERT arm. Healthcare personnel spent significantly more time delivering unscheduled outpatient care for patients receiving cisplatin than for those receiving cetuximab (p = 0.01). No significant difference in the quality of life was suggested at baseline, 6 weeks and 6 months. The mean time to removal of percutaneous gastrostomy (PEG) after completion of radiotherapy was 49.7 weeks in the cisplatin arm and 18.5 weeks in the cetuximab arm (p = 0.04). There was a statistically significant difference in patient-reported use of PEG between the cisplatin and cetuximab arms at 6 months following completion of treatment (p = 0.04). At 21 months, overall survival was 80% in the cisplatin arm vs 50% in the cetuximab (p = 0.332), with disease-free survival being 80% in the cisplatin arm vs 40% in the cetuximab (p = 0.097). Cetuximab is still more expensive in simple drug cost terms than cisplatin when delivered with radiotherapy taking into account costs of drugs for toxicity management and nutritional supplements but other resource implications such as inpatient admission, time spent delivering unscheduled care and cost of additional investigations to manage toxicity for patients treated with cisplatin significantly reduce differential. The study suggested significant differences in patient-reported PEG use at 6 months and in time to PEG removal in favour of the cetuximab arm. Advances in knowledge: There is paucity of randomized data on cost analysis for cisplatin vs cetuximab radiotherapy; this trial informs on the cost analysis between the two approaches.

Sexual and gender-based violence in areas of armed conflict: a systematic review of mental health and psychosocial support interventions

PubMed Central

2013-01-01

Background Sexual and other forms of gender-based violence are common in conflict settings and are known risk factors for mental health and psychosocial wellbeing. We present findings from a systematic review of the academic and grey literature focused on the effectiveness of mental health and psychosocial support interventions for populations exposed to sexual and other forms of gender-based violence in the context of armed conflicts. Methods We searched the Cochrane Database of Systematic Reviews, Cochrane Controlled Trials Register, PubMed/ Medline, psycINFO, and PILOTS, as well as grey literature to search for evaluations of interventions, without date limitations. Results Out of 5,684 returned records 189 full text papers were assessed for eligibility. Seven studies met inclusion criteria: 1 non-randomized controlled study; 3 non-controlled pre- post-test designs; 1 retrospective cohort with a matched comparison group; and 2 case studies. Studies were conducted in West and Central Africa; Albania; UK and USA, included female participants, and focused on individual and group counseling; combined psychological, medical, social and economic interventions; and cognitive behavioral therapy (two single case studies). Conclusions The seven studies, while very limited, tentatively suggest beneficial effects of mental health and psychosocial interventions for this population, and show feasibility of evaluation and implementation of such interventions in real-life settings through partnerships with humanitarian organizations. Robust conclusions on the effectiveness of particular approaches are not possible on the basis of current evidence. More rigorous research is urgently needed. PMID:23915821

Experimental measure of arm stiffness during single reaching movements with a time-frequency analysis

PubMed Central

Pierobon, Alberto; DiZio, Paul; Lackner, James R.

2013-01-01

We tested an innovative method to estimate joint stiffness and damping during multijoint unfettered arm movements. The technique employs impulsive perturbations and a time-frequency analysis to estimate the arm's mechanical properties along a reaching trajectory. Each single impulsive perturbation provides a continuous estimation on a single-reach basis, making our method ideal to investigate motor adaptation in the presence of force fields and to study the control of movement in impaired individuals with limited kinematic repeatability. In contrast with previous dynamic stiffness studies, we found that stiffness varies during movement, achieving levels higher than during static postural control. High stiffness was associated with elevated reflexive activity. We observed a decrease in stiffness and a marked reduction in long-latency reflexes around the reaching movement velocity peak. This pattern could partly explain the difference between the high stiffness reported in postural studies and the low stiffness measured in dynamic estimation studies, where perturbations are typically applied near the peak velocity point. PMID:23945781

Spatiotemporal gait changes with use of an arm swing cueing device in people with Parkinson's disease.

PubMed

Thompson, Elizabeth; Agada, Peter; Wright, W Geoffrey; Reimann, Hendrik; Jeka, John

2017-10-01

Impaired arm swing is a common motor symptom of Parkinson's disease (PD), and correlates with other gait impairments and increased risk of falls. Studies suggest that arm swing is not merely a passive consequence of trunk rotation during walking, but an active component of gait. Thus, techniques to enhance arm swing may improve gait characteristics. There is currently no portable device to measure arm swing and deliver immediate cues for larger movement. Here we test report pilot testing of such a device, ArmSense (patented), using a crossover repeated-measures design. Twelve people with PD walked in a video-recorded gym space at self-selected comfortable and fast speeds. After baseline, cues were given either visually using taped targets on the floor to increase step length or through vibrations at the wrist using ArmSense to increase arm swing amplitude. Uncued walking then followed, to assess retention. Subjects successfully reached cueing targets on >95% of steps. At a comfortable pace, step length increased during both visual cueing and ArmSense cueing. However, we observed increased medial-lateral trunk sway with visual cueing, possibly suggesting decreased gait stability. In contrast, no statistically significant changes in trunk sway were observed with ArmSense cues compared to baseline walking. At a fast pace, changes in gait parameters were less systematic. Even though ArmSense cues only specified changes in arm swing amplitude, we observed changes in multiple gait parameters, reflecting the active role arm swing plays in gait and suggesting a new therapeutic path to improve mobility in people with PD. Copyright © 2017 Elsevier B.V. All rights reserved.

Fibromyalgia with Gabapentin and Osteopathic Manipulative Medicine: A Pilot Study.

PubMed

Marske, Cynthia; Bernard, Natasha; Palacios, Alison; Wheeler, Cary; Preiss, Ben; Brown, Mackenzie; Bhattacharya, Saveri; Klapstein, Gloria

2018-04-01

This pilot study compares the safety and efficacy of three treatments in reducing pain and improving fibromyalgia symptoms. This study was an 8-week prospective, single center feasibility study. Forty subjects were recruited from Solano, Sonoma, and Contra Costa counties of California in 2006-2009. Subjects were aged 18-65 and met the American College of Rheumatology (ACR) 1990 criteria for fibromyalgia. This study had three treatment arms: gabapentin only (900 mg/day), osteopathic manipulative medicine (OMM) only, and combined treatment of gabapentin plus OMM. OMM treatment was administered by advanced medical students for 30 min, once a week. The trial lasted for 8 weeks, which included 6 weeks of treatment plus initial and final visits. Key outcome measures included Wong-Baker FACES Pain Rating Scale (WBF), Clinical Global Impression of Health (CGI), Fibromyalgia Impact Questionnaire (FIQ), and number of tender points. Twenty-nine subjects completed the trial; 8 subjects received gabapentin only, 11 patients received OMM only, and 10 patients received gabapentin plus OMM. Subjects receiving OMM alone and subjects receiving the combined treatment of OMM and gabapentin displayed clinical improvements based on WBF (p < 0.01 and p = 0.03, respectively), while the change among the gabapentin-only group was nonsignificant. The OMM only group was the only group to experience a significant decline in CGI scale (p < 0.01). No statistically significant changes were observed with the FIQ or number of tender points. No differences across groups were statistically significant. This is to be expected in a feasibility study with a small sample size. This pilot study suggests that OMM treatment and gabapentin are safe and clinically efficacious treatment of pain and other constitutional and somatic symptoms associated with fibromyalgia. A larger trial using the new ACR 2010 Fibromyalgia criteria is needed to confirm these findings.

Single pilot scanning behavior in simulated instrument flight

NASA Technical Reports Server (NTRS)

Pennington, J. E.

1979-01-01

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

Description of the LASSO Alpha 1 Release

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

Gustafson, William I.; Vogelmann, Andrew M.; Cheng, Xiaoping

The Department of Energy (DOE) Atmospheric Radiation Measurement (ARM) Climate Research Facility began a pilot project in May 2015 to design a routine, high-resolution modeling capability to complement ARM’s extensive suite of measurements. This modeling capability has been named the Large-Eddy Simulation (LES) ARM Symbiotic Simulation and Observation (LASSO) project. The availability of LES simulations with concurrent observations will serve many purposes. LES helps bridge the scale gap between DOE ARM observations and models, and the use of routine LES adds value to observations. It provides a self-consistent representation of the atmosphere and a dynamical context for the observations. Further,more » it elucidates unobservable processes and properties. LASSO will generate a simulation library for researchers that enables statistical approaches beyond a single-case mentality. It will also provide tools necessary for modelers to reproduce the LES and conduct their own sensitivity experiments. Many different uses are envisioned for the combined LASSO LES and observational library. For an observationalist, LASSO can help inform instrument remote-sensing retrievals, conduct Observation System Simulation Experiments (OSSEs), and test implications of radar scan strategies or flight paths. For a theoretician, LASSO will help calculate estimates of fluxes and co-variability of values, and test relationships without having to run the model yourself. For a modeler, LASSO will help one know ahead of time which days have good forcing, have co-registered observations at high-resolution scales, and have simulation inputs and corresponding outputs to test parameterizations. Further details on the overall LASSO project are available at http://www.arm. gov/science/themes/lasso.« less

Muslim communities learning about second-hand smoke (MCLASS): study protocol for a pilot cluster randomised controlled trial.

PubMed

Ainsworth, Hannah; Shah, Sarwat; Ahmed, Faraz; Amos, Amanda; Cameron, Ian; Fairhurst, Caroline; King, Rebecca; Mir, Ghazala; Parrott, Steve; Sheikh, Aziz; Torgerson, David; Thomson, Heather; Siddiqi, Kamran

2013-09-13

In the UK, 40% of Bangladeshi and 29% of Pakistani men smoke cigarettes regularly compared to the national average of 24%. As a consequence, second-hand smoking is also widespread in their households which is a serious health hazard to non-smokers, especially children. Smoking restrictions in households can help reduce exposure to second-hand smoking. This is a pilot trial of 'Smoke Free Homes', an educational programme which has been adapted for use by Muslim faith leaders, in an attempt to find an innovative solution to encourage Pakistani- and Bangladeshi-origin communities to implement smoking restrictions in their homes. The primary objectives for this pilot trial are to establish the feasibility of conducting such an evaluation and provide information to inform the design of a future definitive study. This is a pilot cluster randomised controlled trial of 'Smoke Free Homes', with an embedded preliminary health economic evaluation and a qualitative analysis. The trial will be carried out in around 14 Islamic religious settings. Equal randomisation will be employed to allocate each cluster to a trial arm. The intervention group will be offered the Smoke Free Homes package (Smoke Free Homes: a resource for Muslim religious teachers), trained in its use, and will subsequently implement the package in their religious settings. The remaining clusters will not be offered the package until the completion of the study and will form the control group. At each cluster, we aim to recruit around 50 households with at least one adult resident who smokes tobacco and at least one child or a non-smoking adult. Households will complete a household survey and a non-smoking individual will provide a saliva sample which will be tested for cotinine. All participant outcomes will be measured before and after the intervention period in both arms of the trial. In addition, a purposive sample of participants and religious leaders/teachers will take part in interviews and focus groups. The results of this pilot study will inform the protocol for a definitive trial. Current Controlled Trials ISRCTN03035510.

Muslim communities learning about second-hand smoke (MCLASS): study protocol for a pilot cluster randomised controlled trial

PubMed Central

2013-01-01

Background In the UK, 40% of Bangladeshi and 29% of Pakistani men smoke cigarettes regularly compared to the national average of 24%. As a consequence, second-hand smoking is also widespread in their households which is a serious health hazard to non-smokers, especially children. Smoking restrictions in households can help reduce exposure to second-hand smoking. This is a pilot trial of ‘Smoke Free Homes’, an educational programme which has been adapted for use by Muslim faith leaders, in an attempt to find an innovative solution to encourage Pakistani- and Bangladeshi-origin communities to implement smoking restrictions in their homes. The primary objectives for this pilot trial are to establish the feasibility of conducting such an evaluation and provide information to inform the design of a future definitive study. Methods/Design This is a pilot cluster randomised controlled trial of ‘Smoke Free Homes’, with an embedded preliminary health economic evaluation and a qualitative analysis. The trial will be carried out in around 14 Islamic religious settings. Equal randomisation will be employed to allocate each cluster to a trial arm. The intervention group will be offered the Smoke Free Homes package (Smoke Free Homes: a resource for Muslim religious teachers), trained in its use, and will subsequently implement the package in their religious settings. The remaining clusters will not be offered the package until the completion of the study and will form the control group. At each cluster, we aim to recruit around 50 households with at least one adult resident who smokes tobacco and at least one child or a non-smoking adult. Households will complete a household survey and a non-smoking individual will provide a saliva sample which will be tested for cotinine. All participant outcomes will be measured before and after the intervention period in both arms of the trial. In addition, a purposive sample of participants and religious leaders/teachers will take part in interviews and focus groups. Discussion The results of this pilot study will inform the protocol for a definitive trial. Trial registration Current Controlled Trials ISRCTN03035510 PMID:24034853

Modeling of Prosthetic Limb Rotation Control by Sensing Rotation of Residual Arm Bone

PubMed Central

Kuiken, Todd A.

2011-01-01

We proposed a new approach to improve the control of prosthetic arm rotation in amputees. Arm rotation is sensed by implanting a small permanent magnet into the distal end of the residual bone, which produces a magnetic field. The position of the bone rotation can be derived from magnetic field distribution detected with magnetic sensors on the arm surface, and then conveyed to the prosthesis controller to manipulate the rotation of the prosthesis. Proprioception remains intact for residual limb skeletal structures; thus, this control system should be natural and easy-to-use. In this study, simulations have been conducted in an upper arm model to assess the feasibility and performance of sensing the voluntary rotation of residual humerus with an implanted magnet. A sensitivity analysis of the magnet size and arm size was presented. The influence of relative position of the magnet to the magnetic sensors, orientation of the magnet relative to the limb axis, and displacement of the magnetic sensors on the magnetic field was evaluated. The performance of shielding external magnetostatic interference was also investigated. The simulation results suggest that the direction and angle of rotation of residual humerus could be obtained by decoding the magnetic field signals with magnetic sensors built into a prosthetic socket. This pilot study provides important guidelines for developing a practical interface between the residual bone rotation and the prosthesis for control of prosthetic rotation. PMID:18713682

Nurse-delivered counselling intervention for parental HIV disclosure: results from a pilot randomized controlled trial in China.

PubMed

Simoni, Jane M; Yang, Joyce P; Shiu, Cheng-Shi; Chen, Wei-Ti; Udell, Wadiya; Bao, Meijuan; Zhang, Lin; Lu, Hongzhou

2015-06-01

The objective of this study was to design and conduct a preliminary evaluation of an intervention to assist parents in decision-making about disclosure of their HIV diagnosis to their children. This was a pilot randomized controlled trial (RCT) with blinded assessment. Participants were randomized to intervention or treatment-as-usual (TAU) arms. The study occurred at an outpatient HIV primary care centre in Shanghai, China. Participants were 20 HIV-positive outpatients with at least one child (13-25 years old) who was unaware of the parent's HIV diagnosis. The nurse-delivered intervention involved three, hour-long, individual sessions over 4 weeks. Intervention content comprised family assessment, discussion of advantages and disadvantages of disclosure, psycho-education about cognitive, social and emotional abilities of children at different developmental stages, and disclosure planning and practicing via role-plays. Primary study outcomes for intervention versus TAU arms were self-reported disclosure distress, self-efficacy, and behaviours along a continuum from no disclosure to full disclosure and open communication about HIV. In all cross-sectional (Wald tests) and longitudinal (general estimating equations) analyses, at both postintervention (4 weeks) and follow-up (13 weeks), effects were in the hypothesized directions. Despite the small sample size, most of these between-arm comparisons were statistically significant, with at least one result for each outcome indicating a 'large' effect size. Our results suggest that nurses are able to deliver a counselling intervention in a clinic setting with the potential to alleviate parental distress around HIV disclosure to their children. Findings warrant future trials powered for efficacy.

Design of a multi-arm randomized clinical trial with no control arm.

PubMed

Magaret, Amalia; Angus, Derek C; Adhikari, Neill K J; Banura, Patrick; Kissoon, Niranjan; Lawler, James V; Jacob, Shevin T

2016-01-01

Clinical trial designs that include multiple treatments are currently limited to those that perform pairwise comparisons of each investigational treatment to a single control. However, there are settings, such as the recent Ebola outbreak, in which no treatment has been demonstrated to be effective; and therefore, no standard of care exists which would serve as an appropriate control. For illustrative purposes, we focused on the care of patients presenting in austere settings with critically ill 'sepsis-like' syndromes. Our approach involves a novel algorithm for comparing mortality among arms without requiring a single fixed control. The algorithm allows poorly-performing arms to be dropped during interim analyses. Consequently, the study may be completed earlier than planned. We used simulation to determine operating characteristics for the trial and to estimate the required sample size. We present a potential study design targeting a minimal effect size of a 23% relative reduction in mortality between any pair of arms. Using estimated power and spurious significance rates from the simulated scenarios, we show that such a trial would require 2550 participants. Over a range of scenarios, our study has 80 to 99% power to select the optimal treatment. Using a fixed control design, if the control arm is least efficacious, 640 subjects would be enrolled into the least efficacious arm, while our algorithm would enroll between 170 and 430. This simulation method can be easily extended to other settings or other binary outcomes. Early dropping of arms is efficient and ethical when conducting clinical trials with multiple arms. Copyright © 2015 Elsevier Inc. All rights reserved.

Single-arm phase II trial design under parametric cure models.

PubMed

Wu, Jianrong

2015-01-01

The current practice of designing single-arm phase II survival trials is limited under the exponential model. Trial design under the exponential model may not be appropriate when a portion of patients are cured. There is no literature available for designing single-arm phase II trials under the parametric cure model. In this paper, a test statistic is proposed, and a sample size formula is derived for designing single-arm phase II trials under a class of parametric cure models. Extensive simulations showed that the proposed test and sample size formula perform very well under different scenarios. Copyright © 2015 John Wiley & Sons, Ltd.

Physical performance testing in mucopolysaccharidosis I: a pilot study.

PubMed

Dumas, Helene M; Fragala, Maria A; Haley, Stephen M; Skrinar, Alison M; Wraith, James E; Cox, Gerald F

2004-01-01

To develop and field-test a physical performance measure (MPS-PPM) for individuals with Mucopolysaccharidosis I (MPS I), a rare genetic disorder. Motor performance and endurance items were developed based on literature review, clinician feedback, feasibility, and equipment and training needs. A standardized testing protocol and scoring rules were created. The MPS-PPM includes: Arm Function (7 items), Leg Function (5 items), and Endurance (2 items). Pilot data were collected for 10 subjects (ages 5-29 years). We calculated Spearman's rho correlations between age, severity and summary z-scores on the MPS-PPM. Subjects had variable presentations, as correlations among the three sub-test scores were not significant. Increasing age was related to greater severity in physical performance (r = 0.72, p<0.05) and lower scores on the Leg Function (r = -0.67, p<0.05) and Endurance (r = -0.65, p<0.05) sub-tests. The MPS-PPM was sensitive to detecting physical performance deficits, as six subjects could not complete the full battery of Arm Function items and eight subjects were unable to complete all Leg Function items. Subjects walked more slowly and expended more energy than typically developing peers. Individuals with MPS I have difficulty with arm and leg function and reduced endurance. The MPS-PPM is a clinically feasible measure that detects limitations in physical performance and may have potential to quantify changes in function following intervention. Copyright 2004 Taylor and Francis Ltd.

Is Homeopathy Effective for Hot Flashes and Other Estrogen-Withdrawl Symptoms in Breast Cancer Survivors? A Preliminary Randomized Controlled Trial

DTIC Science & Technology

2001-09-01

symptoms for more than 100 years. To carry out a pilot study to determine whether there is evidence that homeopathy is an effective treatment to improve the...one month, with at least 3 hot flashes per day. Subjects have been randomized to one of three treatment arms: classical homeopathy , a combination

Exposure assessment in different occupational groups at a hospital using Quick Exposure Check (QEC) - a pilot study.

PubMed

Ericsson, Pernilla; Björklund, Martin; Wahlström, Jens

2012-01-01

In order to test the feasibility and sensitivity of the ergonomic exposure assessment tool Quick Exposure Check (QEC), a pilot-study was conducted. The aim was to test QEC in different occupational groups to compare the exposure in the most common work task with the exposure in the work task perceived as the most strenuous for the neck/shoulder region, and to test intra-observer reliability. One experienced ergonomist observed 23 workers. The mean observation time was 45 minutes, waiting time and time for complementary questions included. The exposure scores varied between the different occupational groups as well as between workers within the occupational groups. Eighteen workers rated their most common work task as also being the most strenuous for the neck/shoulder region. For the remaining five workers, the mean exposure score were higher both for the neck and shoulder/arm in the most common work task. Intra-observer reliability shows agreement in 86% of the exposure interactions in the neck and in 71% in the shoulder/arm. QEC seems to fulfill the expectations of being a quick, sensible and practical exposure assessment tool that covers physical risk factors in the neck, upper extremities and low back.

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

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

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

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

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

PubMed

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

2015-07-01

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

Large Scale Ice Water Path and 3-D Ice Water Content

DOE Data Explorer

Liu, Guosheng

2008-01-15

Cloud ice water concentration is one of the most important, yet poorly observed, cloud properties. Developing physical parameterizations used in general circulation models through single-column modeling is one of the key foci of the ARM program. In addition to the vertical profiles of temperature, water vapor and condensed water at the model grids, large-scale horizontal advective tendencies of these variables are also required as forcing terms in the single-column models. Observed horizontal advection of condensed water has not been available because the radar/lidar/radiometer observations at the ARM site are single-point measurement, therefore, do not provide horizontal distribution of condensed water. The intention of this product is to provide large-scale distribution of cloud ice water by merging available surface and satellite measurements. The satellite cloud ice water algorithm uses ARM ground-based measurements as baseline, produces datasets for 3-D cloud ice water distributions in a 10 deg x 10 deg area near ARM site. The approach of the study is to expand a (surface) point measurement to an (satellite) areal measurement. That is, this study takes the advantage of the high quality cloud measurements at the point of ARM site. We use the cloud characteristics derived from the point measurement to guide/constrain satellite retrieval, then use the satellite algorithm to derive the cloud ice water distributions within an area, i.e., 10 deg x 10 deg centered at ARM site.

Triple Therapy with Scopolamine, Ondansetron, and Dexamethasone for Prevention of Postoperative Nausea and Vomiting in Moderate to High-Risk Patients Undergoing Craniotomy Under General Anesthesia: A Pilot Study.

PubMed

Bergese, Sergio D; Antor, Maria A; Uribe, Alberto A; Yildiz, Vedat; Werner, Joseph

2015-01-01

Postoperative nausea and vomiting (PONV) is one of the most common complaints from patients and clinicians after a surgical procedure. According to the current Society of Ambulatory Anesthesia Consensus Guidelines, the general incidence of vomiting and nausea is around 30 and 50%, respectively; and up to 80% in high-risk patients. In previous studies, the reported incidence of PONV at 24 h after craniotomy was 43-70%. The transdermal scopolamine (TDS) delivery system contains a 1.5-mg drug reservoir, which is designed to deliver a continuous slow release of scopolamine through intact skin during the first 72 h of patch application. Therefore, we designed this single arm, non-randomized, pilot study to assess the efficacy and safety of triple therapy with scopolamine, ondansetron, and dexamethasone to prevent PONV. In the preoperative area, subjects received an active TDS 1.5 mg that was applied to a hairless patch of skin in the mastoid area approximately 2 h prior to the operation. Immediately after anesthesia induction, all patients received a single 4 mg dose of ondansetron IV and a single 10 mg dose of dexamethasone IV. Patients who experienced nausea and/or vomiting received ondansetron 4 mg IV as the initial rescue medication. Postoperative nausea and vomiting assessments were performed for up to 120 h after surgery. A total of 36 subjects were analyzed. The overall incidence of PONV during the first 24 h after neurological surgery was 33% (n = 12). The incidence of nausea and emesis during the first 24 h after surgery was recorded as 33% (n = 12) and 16% (n = 6), respectively. Our data showed that this triple therapy regimen may be an efficient alternative regimen for PONV prophylaxis in patients undergoing neurological surgery with general anesthesia. Further studies using regimens affecting different receptor pathways should be performed to better prove the efficacy and safety in the prevention or delay of PONV.

Single pilot IFR accident data analysis

NASA Technical Reports Server (NTRS)

Harris, D. F.

1983-01-01

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

Development of Hybrid Computer Programs for AAFSS/COBRA/COIN Weapons Effectiveness Studies. Volume I. Simulating Aircraft Maneuvers and Weapon Firing Runs.

DTIC Science & Technology

for the game. Subsequent duels , flown with single armed escorts, calculated reduction in losses and damage states. For the study, hybrid computer...6) a duel between a ground weapon, armed escort, and formation of lift aircraft. (Author)

Is there a role for physician involvement in introducing research to surrogate decision makers in the intensive care unit? (The Approach trial: a pilot mixed methods study).

PubMed

Burns, K E A; Rizvi, L; Smith, O M; Lee, Y; Lee, J; Wang, M; Brown, M; Parker, M; Premji, A; Leung, D; Hammond Mobilio, M; Gotlib-Conn, L; Nisenbaum, R; Santos, M; Li, Y; Mehta, S

2015-01-01

To assess the feasibility of conducting a randomized trial comparing two strategies [physician (MD) vs. non-physician (non-MD)] for approaching substitute decision makers (SDMs) for research and to evaluate SDMs' experiences in being approached for consent. A pilot mixed methods study of first encounters with SDMs. Of 137 SDMs (162 eligibility events), 67 and 70 were randomized to MD and non-MD introductions, respectively. Eighty SDMs (98 events) provided consent and 21 SDMs (24 events) declined consent for studies, including 2 SDMs who provided and declined consent. We identified few missed introductions [4/52 (7.7 %)] and protocol violations [6/117 (5.1 %)], high comfort, satisfaction and acceptance scores and similar consent rates in both arms. SDMs provided consent significantly more often when a patient update was provided in the MD arm. Most SDMs (85.7 %) felt that physician involvement was inconsequential and preferred physician time to be dedicated to patient care; however, SDM experiences were closely related to their recall of being approached and recall was poor. SDMs highlighted 7 themes of importance to them in research surrogate decision-making. SDMs prioritized the personal attributes of the person approaching them over professional designation and preferred physician time to be dedicated to patient care. A mixed methods design evaluated intervention fidelity and provided the rationale for not proceeding to a larger trial, despite achieving all feasibility metrics in the pilot trial. NCT01232621.

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

NASA Technical Reports Server (NTRS)

Musgrave, Jeffrey L.

1997-01-01

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

Application of System Identification Methods for Decoding Imagined Single-Joint Movements in an Individual with High Tetraplegia

PubMed Central

Ajiboye, A. Bolu; Hochberg, Leigh R.; Donoghue, John P.; Kirsch, Robert F.

2013-01-01

This study investigated the decoding of imagined arm movements from M1 in an individual with high level tetraplegia. The participant was instructed to imagine herself performing a series of single-joint arm movements, aided by the visual cue of an animate character performing these movements. System identification was used offline to predict the trajectories of the imagined movements and compare these predictions to the trajectories of the actual movements. We report rates of 25 – 50% for predicting completely imagined arm movements in the absence of a priori movements to aid in decoder building. PMID:21096197

A Pilot Study for Applying an Extravehicular Activity Exercise Prebreathe Protocol to the International Space Station

NASA Technical Reports Server (NTRS)

Woodruff, Kristin K.; Johnson, Anyika N.; Lee, Stuart M. C.; Gernhardt, Michael; Schneider, Suzanne M.; Foster, Philip P.

2000-01-01

Decompression sickness (DCS) is a serious risk to astronauts performing extravehicular activity (EVA). To reduce this risk, the addition of ten minutes of moderate exercise (75% VO2pk) during prebreathe has been shown to decrease the total prebreathe time from 4 to 2 hours and to decrease the incidence of DCS. The overall purpose of this pilot study was to develop an exercise protocol using flight hardware and an in-flight physical fitness cycle test to perform prebreathe exercise before an EVA. Eleven subjects volunteered to participate in this study. The first objective of this study was to compare the steady-state heart rate (HR) and oxygen consumption (VO2) from a submaximal arm and leg exercise (ALE) session with those predicted from a maximal ALE test. The second objective was to compare the steady-state HR and V02 from a submaximal elastic tube and leg exercise (TLE) session with those predicted from the maximal ALE test. The third objective involved a comparison of the maximal ALE test with a maximal leg-only (LE) test to conform to the in- flight fitness assessment test. The 75% VO2pk target HR from the LE test was significantly less than the target HR from the ALE test. Prescribing exercise using data from the maximal ALE test resulted in the measured submaximal values being higher than predicted VO2 and HR. The results of this pilot study suggest that elastic tubing is valid during EVA prebreathe as a method of arm exercise with the flight leg ergometer and it is recommended that prebreathe countermeasure exercise protocol incorporate this method.

Methodological challenges in evaluating the effectiveness of women's crisis houses compared with psychiatric wards: findings from a pilot patient preference RCT.

PubMed

Howard, Louise M; Leese, Morven; Byford, Sarah; Killaspy, Helen; Cole, Laura; Lawlor, Caroline; Johnson, Sonia

2009-10-01

There are several methodological difficulties to address when evaluating acute psychiatric services. This study explored potential methods in evaluating the effectiveness of women's crisis houses compared with psychiatric wards in a pilot patient preference randomized controlled trial. Women requiring voluntary admission to a psychiatric hospital or women's crisis house were asked to enter this pilot and different options for recruitment were explored, including different recruitment sites in the pathway to admission and methods for including women without capacity. Forty-one percent (n = 42) of women entering the study agreed to be randomized and 59% (n = 61) entered patient preference arms. Only 7% of women were recruited before admission and 1 woman without capacity entered the study, despite procedures to facilitate this. Recruitment of patients with acute psychiatric crises is therefore challenging; researchers evaluating acute services should establish a consensus on how ethically and practically to recruit patients in this setting.

Single-joint outcome measures: preliminary validation of patient-reported outcomes and physical examination.

PubMed

Heald, Alison E; Fudman, Edward J; Anklesaria, Pervin; Mease, Philip J

2010-05-01

To assess the validity, responsiveness, and reliability of single-joint outcome measures for determining target joint (TJ) response in patients with inflammatory arthritis. Patient-reported outcomes (PRO), consisting of responses to single questions about TJ global status on a 100-mm visual analog scale (VAS; TJ global score), function on a 100-mm VAS (TJ function score), and pain on a 5-point Likert scale (TJ pain score) were piloted in 66 inflammatory arthritis subjects in a phase 1/2 clinical study of an intraarticular gene transfer agent and compared to physical examination measures (TJ swelling, TJ tenderness) and validated function questionnaires (Disabilities of the Arm, Shoulder and Hand scale, Rheumatoid Arthritis Outcome Score, and the Health Assessment Questionnaire). Construct validity was assessed by evaluating the correlation between the single-joint outcome measures and validated function questionnaires using Spearman's rank correlation. Responsiveness or sensitivity to change was assessed through calculating effect size and standardized response means (SRM). Reliability of physical examination measures was assessed by determining interobserver agreement. The single-joint PRO were highly correlated with each other and correlated well with validated functional measures. The TJ global score exhibited modest effect size and modest SRM that correlated well with the patient's assessment of response on a 100-mm VAS. Physical examination measures exhibited high interrater reliability, but correlated less well with validated functional measures and the patient's assessment of response. Single-joint PRO, particularly the TJ global score, are simple to administer and demonstrate construct validity and responsiveness in patients with inflammatory arthritis. (ClinicalTrials.gov identifier NCT00126724).

Standard versus accelerated initiation of renal replacement therapy in acute kidney injury (STARRT-AKI): study protocol for a randomized controlled trial.

PubMed

Smith, Orla M; Wald, Ron; Adhikari, Neill K J; Pope, Karen; Weir, Matthew A; Bagshaw, Sean M

2013-10-05

Acute kidney injury is a common and devastating complication of critical illness, for which renal replacement therapy is frequently needed to manage severe cases. While a recent systematic review suggested that "earlier" initiation of renal replacement therapy improves survival, completed trials are limited due to small size, single-centre status, and use of variable definitions to define "early" renal replacement therapy initiation. This is an open-label pilot randomized controlled trial. One hundred critically ill patients with severe acute kidney injury will be randomly allocated 1:1 to receive "accelerated" initiation of renal replacement therapy or "standard" initiation at 12 centers across Canada. In the accelerated arm, participants will have a venous catheter placed and renal replacement therapy will be initiated within 12 hours of fulfilling eligibility. In the standard initiation arm, participants will be monitored over 7 days to identify indications for renal replacement therapy. For participants in the standard arm with persistent acute kidney injury, defined as a serum creatinine not declining >50% from the value at the time of eligibility, the initiation of RRT will be discouraged unless one or more of the following criteria are fulfilled: serum potassium ≥6.0 mmol/L; serum bicarbonate ≤10 mmol/L; severe respiratory failure (PaO₂/FiO₂<200) or persisting acute kidney injury for ≥72 hours after fulfilling eligibility. The inclusion criteria are designed to identify a population of critically ill adults with severe acute kidney injury who are likely to need renal replacement therapy during their hospitalization, but not immediately. The primary outcome is protocol adherence (>90%). Secondary outcomes include measures of feasibility (proportion of eligible patients enrolled in the trial, proportion of enrolled patients followed to 90 days for assessment of vital status and the need for renal replacement therapy) and safety (occurrence of adverse events). The optimal timing of renal replacement therapy initiation in patients with severe acute kidney injury remains uncertain, representing an important knowledge gap and a priority for high-quality research. This pilot trial is necessary to establish protocol feasibility, confirm the safety of participants and obtain estimated events rates for design of a large definitive trial. NCT01557361.

Apolipoprotein E genotyping by multiplex tetra-primer amplification refractory mutation system PCR in single reaction tube.

PubMed

Yang, Young Geun; Kim, Jong Yeol; Park, Su Jeong; Kim, Suhng Wook; Jeon, Ok-Hee; Kim, Doo-Sik

2007-08-31

Apolipoprotein E (APOE) plays a critical role in lipoprotein metabolism by binding to both low-density lipoprotein and APOE receptors. The APOE gene has three allelic forms, epsilon2, epsilon3, and epsilon4, which encode different isoforms of the APOE protein. In this study, we have developed a new genotyping method for APOE. Our multiplex tetra-primer amplification refractory mutation system (multiplex T-ARMS) polymerase chain reaction (PCR) was performed in a single reaction tube with six primers consisting of two common primers and two specific primers for each of two single nucleotide polymorphism (SNP) sites. We obtained definitive electropherograms that showed three (epsilon2/epsilon2, epsilon3/epsilon3, and epsilon4/epsilon4), four (epsilon2/epsilon3 and epsilon3/epsilon4), and five (epsilon2/epsilon4) amplicons by multiplex T-ARMS PCR in a single reaction tube. Multiplex T-ARMS PCR for APOE genotyping is a simple and accurate method that requires only a single PCR reaction, without any another treatments or expensive instrumentation, to simultaneously identify two sites of single nucleotide polymorphisms.

Prediction of Imagined Single-Joint Movements in a Person with High Level Tetraplegia

PubMed Central

Simeral, John D.; Donoghue, John P.; Hochberg, Leigh R.; Kirsch, Robert F.

2013-01-01

Cortical neuroprostheses for movement restoration require developing models for relating neural activity to desired movement. Previous studies have focused on correlating single-unit activities (SUA) in primary motor cortex to volitional arm movements in able-bodied primates. The extent of the cortical information relevant to arm movements remaining in severely paralyzed individuals is largely unknown. We record intracortical signals using a microelectrode array chronically implanted in the precentral gyrus of a person with tetraplegia, and estimate positions of imagined single-joint arm movements. Using visually guided motor imagery, the participant imagined performing eight distinct single-joint arm movements while SUA, multi-spike trains (MSP), multi-unit activity (MUA), and local field potential time (LFPrms) and frequency signals (LFPstft) were recorded. Using linear system identification, imagined joint trajectories were estimated with 20 – 60% variance explained, with wrist flexion/extension predicted the best and pronation/supination the poorest. Statistically, decoding of MSP and LFPstft yielded estimates that equaled those of SUA. Including multiple signal types in a decoder increased prediction accuracy in all cases. We conclude that signals recorded from a single restricted region of the precentral gyrus in this person with tetraplegia contained useful information regarding the intended movements of upper extremity joints. PMID:22851229

A prospective pilot study of Dilapan-S compared with Propess for induction of labour at 41+ weeks in nulliparous pregnancy.

PubMed

Crosby, David A; O'Reilly, Claire; McHale, Helen; McAuliffe, Fionnuala M; Mahony, Rhona

2017-12-21

The incidence of labour induction has risen worldwide over the past decade, and this may contribute to the rising caesarean delivery rate. The mechanisms for induction of labour are generally divided into two categories: mechanical and pharmacological. The objective of this study was to determine if mechanical induction with Dilapan-S is an acceptable, safe method of induction of labour in post-dates uncomplicated nulliparous pregnancy. This was a single-centre prospective observational pilot study trial. Fifty-two low-risk nulliparous women with an unfavourable cervix, scheduled for induction of labour for post-dates ≥ 41 weeks gestation, were offered induction of labour with Dilapan-S or Propess from May 2016 until November 2016. The primary outcomes measured were compliance to study protocol and maternal (infection, hyperstimulation) and neonatal outcomes (Apgar score at birth). The secondary outcome measures included change in Bishop's score and caesarean delivery rate. Compliance to study protocol was 25/26 (96%); it was possible to insert Dilapan-S in all but one woman. There were no differences in maternal and neonatal primary outcomes between the groups. There were no cases in either arm of hyperstimulation with either induction method. No difference between the groups was noted in the caesarean delivery rate nor in the mean change in Bishop's score. Dilapan-S is an acceptable, safe form of induction of labour in post-dates uncomplicated nulliparous pregnancy. No cases of hyperstimulation were found, and therefore, Dilapan-S may be a suitable option for outpatient induction of labour in low-risk post-dates nulliparas.

Acceptability of a microenterprise intervention among female sex workers in Chennai, India.

PubMed

Sherman, Susan G; Srikrishnan, A K; Rivett, Katharine A; Liu, Su-Hsun; Solomon, Suniti; Celentano, David D

2010-06-01

Female sex workers have been central in India's HIV epidemic since it was first diagnosed among them in 1989. Female sex workers' risk of HIV is primarily economically motivated. The Pi pilot study examined the feasibility and association of a microenterprise intervention, the tailoring of canvas bags, on sexual risk behaviors among female sex workers (N = 100) in Chennai. Women were randomized to an intervention or control arm. Between-group comparisons at baseline and at six-month follow-up were performed. Multivariate linear regression with bootstrapping was conducted to estimate the intervention effect. At baseline, women were a median of 35 years old, 61% were married and they had an average of two children. Intervention participants reported a significantly lower number of sex partners and significant increases in income at the 6-month follow-up compared to control participants. In a multivariate model, intervention participants had a significantly lower number of paying clients per month at follow-up compared to control participants. By graduation, 75% of intervention arm participants had made at least one sellable canvas bag and 6 months after the study's end, 60% have continued involvement in bag production. The pilot study demonstrated that microenterprise interventions are successful in both providing FSWs with licit income opportunities and was associated with reductions in HIV risk behaviors.

Use of Low-Literacy Decision Aid to Enhance Knowledge and Reduce Decisional Conflict Among a Diverse Population of Adults With Rheumatoid Arthritis: Results of a Pilot Study.

PubMed

Barton, Jennifer L; Trupin, Laura; Schillinger, Dean; Evans-Young, Gina; Imboden, John; Montori, Victor M; Yelin, Edward

2016-07-01

Despite innovations in treatment of rheumatoid arthritis (RA), adherence is poor and disparities persist. Shared decision making (SDM) promotes patient engagement and enhances adherence; however, few tools support SDM in RA. Our objective was to pilot a low-literacy medication guide and decision aid to facilitate patient-clinician conversations about RA medications. RA patients were consecutively enrolled into 1 of 3 arms: 1) control; patients received existing medication guide prior to clinic visit, 2) adapted guide prior to visit, and 3) adapted guide prior to plus decision aid during visit. Outcomes were collected immediately postvisit, at 1-week, and at 3- and 6-month interviews. Eligible adults had to have failed at least 1 disease-modifying antirheumatic drug and fulfill 1 of the following: age >65 years, immigrant, non-English speaker, less than high school education, limited health literacy, and racial/ethnic minority. Primary outcomes were knowledge of RA medications, decisional conflict, and acceptability of interventions. The majority of 166 patients were immigrants (66%), non-English speakers (54%), and had limited health literacy (71%). Adequate RA knowledge postvisit in arm 3 was higher (78%) than arm 1 (53%; adjusted odds ratio 2.7, 95% confidence interval 1.2, 6.1). Among patients with a medication change, there was lower (better) mean decisional conflict in arms 2 and 3 (P = 0.03). There were no significant differences in acceptability. A low-literacy medication guide and decision aid was acceptable, improved knowledge, and reduced decisional conflict among vulnerable RA patients. Enhancing knowledge and patient engagement with decision support tools may lead to medication choices better aligned with RA patients' values and preferences. © 2016, American College of Rheumatology.

Menstrual cups and sanitary pads to reduce school attrition, and sexually transmitted and reproductive tract infections: a cluster randomised controlled feasibility study in rural Western Kenya.

PubMed

Phillips-Howard, Penelope A; Nyothach, Elizabeth; Ter Kuile, Feiko O; Omoto, Jackton; Wang, Duolao; Zeh, Clement; Onyango, Clayton; Mason, Linda; Alexander, Kelly T; Odhiambo, Frank O; Eleveld, Alie; Mohammed, Aisha; van Eijk, Anna M; Edwards, Rhiannon Tudor; Vulule, John; Faragher, Brian; Laserson, Kayla F

2016-11-23

Conduct a feasibility study on the effect of menstrual hygiene on schoolgirls' school and health (reproductive/sexual) outcomes. 3-arm single-site open cluster randomised controlled pilot study. 30 primary schools in rural western Kenya, within a Health and Demographic Surveillance System. Primary schoolgirls 14-16 years, experienced 3 menses, no precluding disability, and resident in the study area. 1 insertable menstrual cup, or monthly sanitary pads, against 'usual practice' control. All participants received puberty education preintervention, and hand wash soap during intervention. Schools received hand wash soap. Primary: school attrition (drop-out, absence); secondary: sexually transmitted infection (STI) (Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoea), reproductive tract infection (RTI) (bacterial vaginosis, Candida albicans); safety: toxic shock syndrome, vaginal Staphylococcus aureus. Of 751 girls enrolled 644 were followed-up for a median of 10.9 months. Cups or pads did not reduce school dropout risk (control=8.0%, cups=11.2%, pads=10.2%). Self-reported absence was rarely reported and not assessable. Prevalence of STIs in the end-of-study survey among controls was 7.7% versus 4.2% in the cups arm (adjusted prevalence ratio (aPR) 0.48, 0.24 to 0.96, p=0.039), 4.5% with pads (aPR=0.62; 0.37 to 1.03, p=0.063), and 4.3% with cups and pads pooled (aPR=0.54, 0.34 to 0.87, p=0.012). RTI prevalence was 21.5%, 28.5% and 26.9% among cup, pad and control arms, 71% of which were bacterial vaginosis, with a prevalence of 14.6%, 19.8% and 20.5%, per arm, respectively. Bacterial vaginosis was less prevalent in the cups (12.9%) compared with pads (20.3%, aPR=0.65, 0.44 to 0.97, p=0.034) and control (19.2%, aPR=0.67, 0.43 to 1.04, p=0.075) arm girls enrolled for 9 months or longer. No adverse events were identified. Provision of menstrual cups and sanitary pads for ∼1 school-year was associated with a lower STI risk, and cups with a lower bacterial vaginosis risk, but there was no association with school dropout. A large-scale trial on menstrual cups is warranted. ISRCTN17486946; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Menstrual cups and sanitary pads to reduce school attrition, and sexually transmitted and reproductive tract infections: a cluster randomised controlled feasibility study in rural Western Kenya

PubMed Central

Phillips-Howard, Penelope A; Nyothach, Elizabeth; ter Kuile, Feiko O; Omoto, Jackton; Wang, Duolao; Zeh, Clement; Onyango, Clayton; Mason, Linda; Alexander, Kelly T; Odhiambo, Frank O; Eleveld, Alie; Mohammed, Aisha; van Eijk, Anna M; Edwards, Rhiannon Tudor; Vulule, John; Faragher, Brian; Laserson, Kayla F

2016-01-01

Objectives Conduct a feasibility study on the effect of menstrual hygiene on schoolgirls' school and health (reproductive/sexual) outcomes. Design 3-arm single-site open cluster randomised controlled pilot study. Setting 30 primary schools in rural western Kenya, within a Health and Demographic Surveillance System. Participants Primary schoolgirls 14–16 years, experienced 3 menses, no precluding disability, and resident in the study area. Interventions 1 insertable menstrual cup, or monthly sanitary pads, against ‘usual practice’ control. All participants received puberty education preintervention, and hand wash soap during intervention. Schools received hand wash soap. Primary and secondary outcome measures Primary: school attrition (drop-out, absence); secondary: sexually transmitted infection (STI) (Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoea), reproductive tract infection (RTI) (bacterial vaginosis, Candida albicans); safety: toxic shock syndrome, vaginal Staphylococcus aureus. Results Of 751 girls enrolled 644 were followed-up for a median of 10.9 months. Cups or pads did not reduce school dropout risk (control=8.0%, cups=11.2%, pads=10.2%). Self-reported absence was rarely reported and not assessable. Prevalence of STIs in the end-of-study survey among controls was 7.7% versus 4.2% in the cups arm (adjusted prevalence ratio (aPR) 0.48, 0.24 to 0.96, p=0.039), 4.5% with pads (aPR=0.62; 0.37 to 1.03, p=0.063), and 4.3% with cups and pads pooled (aPR=0.54, 0.34 to 0.87, p=0.012). RTI prevalence was 21.5%, 28.5% and 26.9% among cup, pad and control arms, 71% of which were bacterial vaginosis, with a prevalence of 14.6%, 19.8% and 20.5%, per arm, respectively. Bacterial vaginosis was less prevalent in the cups (12.9%) compared with pads (20.3%, aPR=0.65, 0.44 to 0.97, p=0.034) and control (19.2%, aPR=0.67, 0.43 to 1.04, p=0.075) arm girls enrolled for 9 months or longer. No adverse events were identified. Conclusions Provision of menstrual cups and sanitary pads for ∼1 school-year was associated with a lower STI risk, and cups with a lower bacterial vaginosis risk, but there was no association with school dropout. A large-scale trial on menstrual cups is warranted. Trial registration ISRCTN17486946; Results PMID:27881530

U-2 Pilot Post-Mission Fatigue Questionnaire

DTIC Science & Technology

2014-10-01

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

Mechanically Reconfigurable Single-Arm Spiral Antenna Array for Generation of Broadband Circularly Polarized Orbital Angular Momentum Vortex Waves.

PubMed

Li, Long; Zhou, Xiaoxiao

2018-03-23

In this paper, a mechanically reconfigurable circular array with single-arm spiral antennas (SASAs) is designed, fabricated, and experimentally demonstrated to generate broadband circularly polarized orbital angular momentum (OAM) vortex waves in radio frequency domain. With the symmetrical and broadband properties of single-arm spiral antennas, the vortex waves with different OAM modes can be mechanically reconfigurable generated in a wide band from 3.4 GHz to 4.7 GHz. The prototype of the circular array is proposed, conducted, and fabricated to validate the theoretical analysis. The simulated and experimental results verify that different OAM modes can be effectively generated by rotating the spiral arms of single-arm spiral antennas with corresponding degrees, which greatly simplify the feeding network. The proposed method paves a reconfigurable way to generate multiple OAM vortex waves with spin angular momentum (SAM) in radio and microwave satellite communication applications.

Comparison of VRX CT scanners geometries

NASA Astrophysics Data System (ADS)

DiBianca, Frank A.; Melnyk, Roman; Duckworth, Christopher N.; Russ, Stephan; Jordan, Lawrence M.; Laughter, Joseph S.

2001-06-01

A technique called Variable-Resolution X-ray (VRX) detection greatly increases the spatial resolution in computed tomography (CT) and digital radiography (DR) as the field size decreases. The technique is based on a principle called `projective compression' that allows both the resolution element and the sampling distance of a CT detector to scale with the subject or field size. For very large (40 - 50 cm) field sizes, resolution exceeding 2 cy/mm is possible and for very small fields, microscopy is attainable with resolution exceeding 100 cy/mm. This paper compares the benefits obtainable with two different VRX detector geometries: the single-arm geometry and the dual-arm geometry. The analysis is based on Monte Carlo simulations and direct calculations. The results of this study indicate that the dual-arm system appears to have more advantages than the single-arm technique.

Arms control and The President's Strategic Defense Initiative

NASA Astrophysics Data System (ADS)

Bon, J. J.

1985-04-01

The President's Strategic Defense Initiative (SDI) provides the hope for eliminating the threat from ballistic missiles. This study evaluates the impact of SDI on existing and future arms control agreements. Because new or modified space-related treaties are a probable result of the SDI, this study concludes that the best single strategy for arms control negotiations is to preserve overall US interests and maintain open technological options vice severely limiting any space technology that might some day become part of a space-based defensive system.

Viewing an educational video can improve phosphorus control in patients on hemodialysis: a pilot study.

PubMed

Baldwin, David M

2013-01-01

The objective of this single-arm interventional pilot study was to determine whether viewing an educational video about phosphorous and phosphorous control by patients on hemodialysis was associated with improved phosphorous values and improvement in knowledge and attitudes about the topics presented. An educational video was shown to 150 patients at 16 dialysis centers. The change in serum phosphate levels before and after the viewing of an educational video was evaluated. Mean phosphorous levels for patients were lower in the month after viewing the educational video compared to their values over the three months before the video was shown (6.35 versus 6.82 g/dL). This difference was statistically significant on a per patient basis (-0.47 g/dL, p = 0.0006). Of these patients, all with phosphorus levels outside of the normal range (3.5 to 5.5 mg/dL) before viewing the video, 28.4% had phosphorus levels within the normal range within a month after viewing the video. Patients on hemodialysis who watched an educational video had improved phosphorous levels in the month after viewing the video when compared to phosphorus levels over the three months before the video was shown. The video intervention has the advantages of being simple, low-cost, and easy to implement, and is associated with improved phosphorous levels in patients undergoing hemodialysis. The video increased patient compliance with recommended self-care regimens.

An Ecological Momentary Intervention to Reduce Alcohol Consumption in Young Adults Delivered During Drinking Events: Protocol for a Pilot Randomized Controlled Trial.

PubMed

Wright, Cassandra Jc; Dietze, Paul M; Agius, Paul A; Kuntsche, Emmanuel; Room, Robin; Livingston, Michael; Hellard, Margaret; Lim, Megan Sc

2017-05-25

Risky drinking is a significant public health issue in young Australian adults. Brief interventions are one of few effective methods of reducing risky drinking but are time and cost intensive; innovative methods of delivery are therefore of interest. Mobile phones offer new opportunities to collect data and intervene during risky drinking events. Mobile phones have successfully been used for delivery of alcohol-related brief interventions and data collection but not in combination with or during drinking events. This pilot study will investigate the efficacy of an ecological momentary intervention (EMI), with combined ecological momentary assessment (EMA) and brief intervention delivered by mobile phones to young adults during risky drinking events. We will use a 3-armed randomized controlled trial to investigate the efficacy of the intervention for reducing peak single occasion drinking. Our sample is recruited from an observational cohort study of young, risky drinkers. Participants will be randomized into 1 of 3 intervention arms. On 6 nights across a 12-week study period, EMI and EMA groups will complete hourly EMA surveys on their mobile phone. EMI participants will receive tailored feedback short message service (SMS) texts corresponding to their EMA survey responses. The EMI participants will not receive feedback SMS. A third group will have no contact (no-contact control). All groups will then be contacted for a follow-up interview within 4 weeks of the 12-week study period ending. The primary outcome is mean reduction in standard drinks consumed during their most recent heavy drinking occasion as measured at follow-up. Secondary outcomes include alcohol consumption over the previous 6 months, experiences of alcohol-related harms, attitudes toward drinking and drunkenness, hazardous drinking and use of tobacco and illicit drugs. A random effects mixed modelling approach using maximum likelihood estimation will be used to provide estimates of differences in mean drinking levels between those receiving the intervention and control participants. This study is novel in that, unlike previous work, it will intervene repeatedly during single occasion drinking events. Further, it extends previous research in this area, which has applied limited tailoring of message content for SMS-based brief interventions. The findings of this study will contribute to the growing body of evidence to inform the use of mobile health interventions for reducing alcohol consumption and harms. Australian New Zealand Clinical Trials ACTRN12616001323415; https://www.anzctr.org.au/ Trial/Registration/TrialReview.aspx?id=369534 (Archived by WebCite at http://www.webcitation.org/ 6qDqBZV9b). ©Cassandra JC Wright, Paul M Dietze, Paul A Agius, Emmanuel Kuntsche, Robin Room, Michael Livingston, Margaret Hellard, Megan SC Lim. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 25.05.2017.

An Ecological Momentary Intervention to Reduce Alcohol Consumption in Young Adults Delivered During Drinking Events: Protocol for a Pilot Randomized Controlled Trial

PubMed Central

Dietze, Paul M; Agius, Paul A; Kuntsche, Emmanuel; Room, Robin; Livingston, Michael; Hellard, Margaret; Lim, Megan SC

2017-01-01

Background Risky drinking is a significant public health issue in young Australian adults. Brief interventions are one of few effective methods of reducing risky drinking but are time and cost intensive; innovative methods of delivery are therefore of interest. Mobile phones offer new opportunities to collect data and intervene during risky drinking events. Mobile phones have successfully been used for delivery of alcohol-related brief interventions and data collection but not in combination with or during drinking events. Objective This pilot study will investigate the efficacy of an ecological momentary intervention (EMI), with combined ecological momentary assessment (EMA) and brief intervention delivered by mobile phones to young adults during risky drinking events. Methods We will use a 3-armed randomized controlled trial to investigate the efficacy of the intervention for reducing peak single occasion drinking. Our sample is recruited from an observational cohort study of young, risky drinkers. Participants will be randomized into 1 of 3 intervention arms. On 6 nights across a 12-week study period, EMI and EMA groups will complete hourly EMA surveys on their mobile phone. EMI participants will receive tailored feedback short message service (SMS) texts corresponding to their EMA survey responses. The EMI participants will not receive feedback SMS. A third group will have no contact (no-contact control). All groups will then be contacted for a follow-up interview within 4 weeks of the 12-week study period ending. Results The primary outcome is mean reduction in standard drinks consumed during their most recent heavy drinking occasion as measured at follow-up. Secondary outcomes include alcohol consumption over the previous 6 months, experiences of alcohol-related harms, attitudes toward drinking and drunkenness, hazardous drinking and use of tobacco and illicit drugs. A random effects mixed modelling approach using maximum likelihood estimation will be used to provide estimates of differences in mean drinking levels between those receiving the intervention and control participants. Conclusions This study is novel in that, unlike previous work, it will intervene repeatedly during single occasion drinking events. Further, it extends previous research in this area, which has applied limited tailoring of message content for SMS-based brief interventions. The findings of this study will contribute to the growing body of evidence to inform the use of mobile health interventions for reducing alcohol consumption and harms. Trial Registration Australian New Zealand Clinical Trials ACTRN12616001323415; https://www.anzctr.org.au/ Trial/Registration/TrialReview.aspx?id=369534 (Archived by WebCite at http://www.webcitation.org/ 6qDqBZV9b) PMID:28546136

Gaining information about home visits in primary care: methodological issues from a feasibility study

PubMed Central

2014-01-01

Background Home visits are part of general practice work in Germany. Within the context of an expanding elderly population and a decreasing number of general practitioner (GPs), open questions regarding the organisation and adequacy of GPs’ care in immobile patients remain. To answer these questions, we will conduct a representative primary data collection concerning contents and organisation of GPs’ home visits in 2014. Because this study will require considerable efforts for documentation and thus substantial involvement by participating GPs, we conducted a pilot study to see whether such a study design was feasible. Methods We used a mixed methods design with two study arms in a sample of teaching GPs of the University Halle. The quantitative arm evaluates participating GPs and documentation of home visits. The qualitative arm focuses on reasons for non-participation for GPs who declined to take part in the pilot study. Results Our study confirms previously observed reasons for non-response of GPs in the particular setting of home visits including lack of time and/or interest. In contrast to previous findings, monetary incentives were not crucial for GPs participation. Several factors influenced the documentation rate of home visits and resulted in a discrepancy between the numbers of home visits documented versus those actually conducted. The most frequently reported problem was related to obtaining patient consent, especially when patients were unable to provide informed consent due to cognitive deficits. Conclusions The results of our feasibility study provide evidence for improvement of the study design and study instruments to effectively conduct a documentation-intensive study of GPs doing home visits. Improvement of instructions and questionnaire regarding time variables and assessment of the need for home visits will be carried out to increase the reliability of future data. One particularly important methodological issue yet to be resolved is how to increase the representativeness of home visit care by including the homebound patient population that is unable to provide informed consent. PMID:24884460

Nurse-delivered counselling intervention for parental HIV disclosure: Results from a pilot randomized controlled trial in China

PubMed Central

Simoni, Jane M.; Yang, Joyce P.; Shiu, Cheng-Shi; Chen, Wei-ti; Udell, Wadiya; Bao, Meijuan; Zhang, Lin; Lu, Hongzhou

2016-01-01

Objective The objective of this study was to design and conduct a preliminary evaluation of an intervention to assist parents in decision-making about disclosure of their HIV diagnosis to their children. Design This was a pilot randomized controlled trial (RCT) with blinded assessment. Participants were randomized to intervention or treatment-as-usual (TAU) arms. Setting The study occurred at an outpatient HIV primary care centre in Shanghai, China. Participants Participants were 20 HIV-positive outpatients with at least one child (13–25 years old) who was unaware of the parent’s HIV diagnosis. Intervention The nurse-delivered intervention involved three, hour-long, individual sessions over 4 weeks. Intervention content comprised family assessment, discussion of advantages and disadvantages of disclosure, psycho-education about cognitive, social and emotional abilities of children at different developmental stages, and disclosure planning and practicing via role-plays. Main outcome measure(s) Primary study outcomes for intervention versus TAU arms were self-reported disclosure distress, self-efficacy and behaviours along a continuum from no disclosure to full disclosure and open communication about HIV. Results In all cross-sectional (Wald tests) and longitudinal (general estimating equations) analyses, at both postintervention (4 weeks) and follow-up (13 weeks), effects were in the hypothesized directions. Despite the small sample size, most of these between-arm comparisons were statistically significant, with at least one result for each outcome indicating a ‘large’ effect size. Conclusion Our results suggest that nurses are able to deliver a counselling intervention in a clinic setting with the potential to alleviate parental distress around HIV disclosure to their children. Findings warrant future trials powered for efficacy. PMID:26049544

Scented guide ropes as a method to enhance brown treesnake (Boiga irregularis) trap capture success on Guam

USGS Publications Warehouse

Mason, L.C.; Savidge, J.A.; Rodda, G.H.; Yackel Adams, A.A.

2011-01-01

Current methods for controlling the invasive Brown Treesnake (Boiga irregularis) on Guam include a modified minnow trap with a live mouse lure. We investigated the effects on capture success of augmenting these traps with scented guide ropes leading to trap entrances. Initial screening of scent preferences was based on time spent in scented and unscented arms of a Y-maze. Preferences of large and small snakes were scored for six different prey scents (live and carrion gecko, skink, and mouse). Large snakes spent more time in the maze arm scented with live gecko and carrion gecko, whereas small snakes spent more time in the arm scented with carrion mouse and carrion gecko. After the laboratory study, a pilot trapping session was conducted in the field using three treatments (live mouse-scented ropes, carrion gecko-scented ropes, and carrion mouse-scented ropes) and two controls (traps with unscented guide ropes and those with no ropes attached). Contrary to laboratory results, live mouse-scented ropes were most effective. We conducted a second trapping session using live mouse-scented ropes as well as the two controls used in the pilot study. For snakes of below-average to average condition, the number of captures for traps with live mouse-scented ropes was higher than for traps with no ropes. However, for snakes of above-average condition, there were no differences in capture rates between trap treatments. Overall, treatment effects were weaker than latent individual heterogeneity and the influence of snake body size, with large snakes trapped more readily. ?? 2011 Society for the Study of Amphibians and Reptiles.

The effect of differential training-based occupational therapy on hand and arm function in patients after stroke: Results of the pilot study.

PubMed

Repšaitė, Viktorija; Vainoras, Alfonsas; Berškienė, Kristina; Baltaduonienė, Daiva; Daunoravičienė, Algė; Sendžikaitė, Ernesta

2015-01-01

The aim of this study was to evaluate the effect of differential training-based occupational therapy on the recovery of arm function and to compare these data with the results obtained after conventional occupational therapy. A total of 27 patients who had suffered a cerebral infarction in the left brain hemisphere were recruited for the study. There were 9 men (33.33%) and 18 women (66.67%). All the patients had paresis of the right arm. The patients were divided into 2 groups: the control group comprised 15 patients who were given conventional occupational therapy (5 times per week) and the study group consisted of 12 patients who underwent conventional occupational therapy (3 times per week) along with occupational therapy based on differential training (2 times per week). In the control group, the mean performance time of only 2 tasks, i.e., flip cards and fold towel, improved significantly (P<0.05), while significant deterioration in the mean performance time of the task "lift can" was observed (P<0.05). In the study group, the mean performance time of all the tasks except for forearm to box (side), hand to box (front), and lift paperclip improved significantly (P<0.05), and no deterioration in arm function was observed. Both patients' groups improved arm function after occupational therapy sessions, but the patients who underwent conventional occupational therapy along with differential training-based occupational therapy recovered their arm function more effectively than their counterparts after conventional occupational therapy. Copyright © 2015 Polish Neurological Society. Published by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

INfluence of Successful Periodontal Intervention in REnal Disease (INSPIRED): study protocol for a randomised controlled pilot clinical trial.

PubMed

Sharma, Praveen; Cockwell, Paul; Dietrich, Thomas; Ferro, Charles; Ives, Natalie; Chapple, Iain L C

2017-11-13

Patients with chronic kidney disease (CKD) exhibit increased morbidity and mortality which is associated with an increased systemic inflammatory burden. Identifying and managing comorbid diseases that contribute to this load may inform novel care pathways that could have a beneficial impact on the morbidity/mortality associated with CKD. Periodontitis, a highly prevalent, chronic inflammatory disease affecting the supporting structures of teeth, is associated with an increased systemic inflammatory and oxidative stress burden and the successful treatment of periodontitis has been shown to reduce both. This pilot study aims to gather data to inform a definitive study into the impact of successful periodontal treatment on the cardio-renal health of patients with CKD. This pilot study will employ a randomised, controlled, parallel-group design. Sixty adult patients, with CKD with a high risk of progression and with periodontitis, from the Queen Elizabeth Hospital, Birmingham, will be randomised to receive either immediate, intensive periodontal treatment (n = 30) or treatment at a delay of 12 months (n = 30). Patients will be excluded if they have reached end-stage renal disease or have received specialist periodontal treatment in the previous year. Periodontal treatment will be delivered under local anaesthetic, on an outpatient basis, over several visits by a qualified dental hygienist at the Birmingham Dental Hospital, UK. Patients in the delayed-treatment arm will continue to receive the standard community level of periodontal care for a period of 12 months followed by the intensive periodontal treatment. Randomization will occur using a centralised telephone randomisation service, following baseline assessments. The assessor of periodontal health will be blinded to the patients' treatment allocation. Patients in either arm will be followed up at 3-monthly intervals for 18 months. Aside from the pilot outcomes to inform the practicalities of a larger trial later, data on cardio-renal function, periodontal health and patient-reported outcomes will be collected at each time point. This pilot randomised controlled trial will investigate the viability of undertaking a larger-scale study investigating the effect of treating periodontitis and maintaining periodontal health on cardio-renal outcomes in patients with CKD. National Institute of Health Research (NIHR) Clinical Research Network (UKCRN ID: 18458), ID: ISRCTN10227738 . Registered retrospectively to both registers on 23 April 2015.

Pilot clinical study of an endoscopic, removable duodenal-jejunal bypass liner for the treatment of type 2 diabetes.

PubMed

Rodriguez, Leonardo; Reyes, Eliana; Fagalde, Pilar; Oltra, Maria Soledad; Saba, Jorge; Aylwin, Carmen Gloria; Prieto, Carolina; Ramos, Almino; Galvao, Manoel; Gersin, Keith S; Sorli, Christopher

2009-11-01

Bariatric surgery is associated with the rapid improvement of type 2 diabetes (T2DM). Here we report an exploratory trial of a completely endoscopic, removable, duodenal-jejunal bypass liner (DJBL) intended to treat T2DM. Obese T2DM subjects were randomized to receive a DJBL (n = 12) or sham endoscopy (n = 6) in a 24-week study, extended up to 52 weeks. Measurements included weights, hemoglobin A1c (HbA(1c)), meal tolerance testing, fasting glucose, and seven-point glucose profiles. Subjects' diets were adjusted in the first 2 weeks to obtain similar weight loss during this period. Subjects had baseline HbA(1c) of 9.1 +/- 1.7% and body mass index of 38.9 +/- 6.1 kg/m(2) (+/- SD). In the completer population by week 1, change in fasting glucose in the DJBL arm was -55 +/- 21 mg/dL versus +42 +/- 30 mg/dL in the sham arm (P < or = 0.05; +/- SE); the seven-point glucose profiles were reduced in the DJBL arm but not in the sham arm. Mean postprandial glucose area under the curve was reduced in the DJBL arm by 20% and increased 17% in the sham arm (P = 0.016). At week 12, HbA(1c) change was -1.3 +/- 0.9% in the DJBL arm and -0.7 +/- 0.4% in the sham arm (P > 0.05), and at 24 weeks, values were -2.4 +/- 0.7% in the DJBL arm and -0.8 +/- 0.4% in the sham arm (P > 0.05). Device migrations required endoscopic removal prior to reaching 52 weeks. The DJBL rapidly normalized glycemic control in obese T2DM subjects, a promising development in the search for novel therapies less invasive than bariatric surgery.

Pharmacy-based interventions for initiating effective contraception following the use of emergency contraception: a pilot study.

PubMed

Michie, L; Cameron, S T; Glasier, A; Larke, N; Muir, A; Lorimer, A

2014-10-01

In Scotland most women get emergency contraception (EC) from pharmacies. Pharmacists currently cannot provide effective ongoing contraception after EC. In this pilot study, we aimed to determine the feasibility of a larger study designed to ascertain if pharmacy-based interventions can increase the uptake of effective contraception after EC. This is a pilot study of women presenting for levonorgestrel EC to community pharmacies in Edinburgh, UK, in 2012. Pharmacies were cluster randomized to provide either standard care or one of two interventions: (a) one packet of progestogen-only pills (POPs), giving women 1 month to arrange ongoing contraception; (b) invitation to present the empty EC packet to a family planning clinic (FPC) for contraceptive advice (rapid access). One hundred sixty-eight women were recruited from 11 pharmacies to POP (n=56), rapid access (n=58) and standard care (N=54) groups, respectively. Telephone follow-up was conducted successfully in 102 women (61%) 6-8 weeks later to determine current contraceptive use. In the POP arm, 35/39 (90%) women used the pills provided, and 9/28 women (32%) in the rapid access arm attended the FPC. The proportion of women using effective contraception at follow-up was significantly greater in both POP [56% (22/39), p=<0.001] and rapid access [52% (13/25), p=0.006] groups compared to standard care [16% (5/31)]. The relative probability of a woman using an effective method of contraception versus barrier/no method, after use of EC, was 3.13 [95% confidence interval (CI), 1.90-5.13] in the POP group and 2.57 (95% CI, 1.55-4.27) in the rapid access group. This promising pilot study suggests that simple pharmacy-based interventions may increase the uptake of effective contraception after EC. A larger study is required to provide further validation of these findings. For women obtaining EC from a pharmacy, simple interventions such as supplying 1 month of a POP, or offering rapid access to a FPC, hold promise as strategies to increase the uptake of effective contraception after EC. Copyright © 2014 Elsevier Inc. All rights reserved.

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.

A pilot study assessing pharmacokinetics and tolerability of oral and intravenous baclofen in healthy adult volunteers.

PubMed

Agarwal, Suresh K; Kriel, Robert L; Cloyd, James C; Coles, Lisa D; Scherkenbach, Lisa A; Tobin, Michael H; Krach, Linda E

2015-01-01

Our objective was to characterize baclofen pharmacokinetics and safety given orally and intravenously. Twelve healthy subjects were enrolled in a randomized, open-label, crossover study and received single doses of baclofen: 3 or 5 mg given intravenously and 5 or 10 mg taken orally with a 48-hour washout. Blood samples for baclofen analysis were collected pre-dose and at regular intervals up to 24 hours post-dose. Clinical response was assessed by sedation scores, ataxia, and nystagmus. Mean absolute bioavailability of oral baclofen was 74%. Dose-adjusted areas under the curve between the oral and intravenous arms were statistically different (P = .0024), whereas area under the curve variability was similar (coefficient of variation: 18%-24%). Adverse effects were mild in severity and not related to either dose or route of administration. Three- and 5-mg intravenous doses of baclofen were well tolerated. Seventy-four percent oral bioavailability indicates that smaller doses of intravenous baclofen are needed to attain comparable total drug exposures. © The Author(s) 2014.

A Randomized Trial of Displaying Paid Price Information on Imaging Study and Procedure Ordering Rates.

PubMed

Chien, Alyna T; Lehmann, Lisa Soleymani; Hatfield, Laura A; Koplan, Kate E; Petty, Carter R; Sinaiko, Anna D; Rosenthal, Meredith B; Sequist, Thomas D

2017-04-01

Prior studies have demonstrated how price transparency lowers the test-ordering rates of trainees in hospitals, and physician-targeted price transparency efforts have been viewed as a promising cost-controlling strategy. To examine the effect of displaying paid-price information on test-ordering rates for common imaging studies and procedures within an accountable care organization (ACO). Block randomized controlled trial for 1 year. A total of 1205 fully licensed clinicians (728 primary care, 477 specialists). Starting January 2014, clinicians in the Control arm received no price display; those in the intervention arms received Single or Paired Internal/External Median Prices in the test-ordering screen of their electronic health record. Internal prices were the amounts paid by insurers for the ACO's services; external paid prices were the amounts paid by insurers for the same services when delivered by unaffiliated providers. Ordering rates (orders per 100 face-to-face encounters with adult patients): overall, designated to be completed internally within the ACO, considered "inappropriate" (e.g., MRI for simple headache), and thought to be "appropriate" (e.g., screening colonoscopy). We found no significant difference in overall ordering rates across the Control, Single Median Price, or Paired Internal/External Median Prices study arms. For every 100 encounters, clinicians in the Control arm ordered 15.0 (SD 31.1) tests, those in the Single Median Price arm ordered 15.0 (SD 16.2) tests, and those in the Paired Prices arms ordered 15.7 (SD 20.5) tests (one-way ANOVA p-value 0.88). There was no difference in ordering rates for tests designated to be completed internally or considered to be inappropriate or appropriate. Displaying paid-price information did not alter how frequently primary care and specialist clinicians ordered imaging studies and procedures within an ACO. Those with a particular interest in removing waste from the health care system may want to consider a variety of contextual factors that can affect physician-targeted price transparency.

Cost analysis of cetuximab (Erbitux) plus radiotherapy (ERT) versus concomitant cisplatin plus radiotherapy (CRT) within an NHS oncology unit (single institution): a pilot study

PubMed Central

Sundus, Yahya; Dawn, Dawson; Carol, Glaister; Susan, Merrick

2016-01-01

Objective: The aim of this feasibility study is to define the resource effectiveness of cetuximab vs cisplatin given concomitantly with radiotherapy for squamous cell carcinoma within a National Health Service clinical oncology unit. Methods: 20 patients with Stage 3 or 4 head and neck squamous cell cancers were randomized to receive either cetuximab with radiotherapy (ERT) or cisplatin with radiotherapy concurrent with external beam radiotherapy 70 Gy in 35 fractions on a 1 : 1 basis over a 12-month duration. The study compared the resource utilization of ERT vs cisplatin with radiotherapy taking into account drug costs, clinical management and the costs of managing treatment-related toxicity from first fraction of radiotherapy to 6 months after the completion of therapy. Outcome measures were quality of life (recorded at the entry, end of radiotherapy, 6 weeks post treatment and 6 months post treatment), admissions to hospital, delays to radiotherapy, locoregional control and survival. Results: Total drug costs including cost of nutritional supplements for patients treated with cetuximab were £7407.45 compared with £3959.07 for patients treated with cisplatin. Unscheduled admissions for toxicity management were significantly more common in the ERT arm. Healthcare personnel spent significantly more time delivering unscheduled outpatient care for patients receiving cisplatin than for those receiving cetuximab (p = 0.01). No significant difference in the quality of life was suggested at baseline, 6 weeks and 6 months. The mean time to removal of percutaneous gastrostomy (PEG) after completion of radiotherapy was 49.7 weeks in the cisplatin arm and 18.5 weeks in the cetuximab arm (p = 0.04). There was a statistically significant difference in patient-reported use of PEG between the cisplatin and cetuximab arms at 6 months following completion of treatment (p = 0.04). At 21 months, overall survival was 80% in the cisplatin arm vs 50% in the cetuximab (p = 0.332), with disease-free survival being 80% in the cisplatin arm vs 40% in the cetuximab (p = 0.097). Conclusion: Cetuximab is still more expensive in simple drug cost terms than cisplatin when delivered with radiotherapy taking into account costs of drugs for toxicity management and nutritional supplements but other resource implications such as inpatient admission, time spent delivering unscheduled care and cost of additional investigations to manage toxicity for patients treated with cisplatin significantly reduce differential. The study suggested significant differences in patient-reported PEG use at 6 months and in time to PEG removal in favour of the cetuximab arm. Advances in knowledge: There is paucity of randomized data on cost analysis for cisplatin vs cetuximab radiotherapy; this trial informs on the cost analysis between the two approaches. PMID:27734748

Using Contingent Reinforcement to Augment Muscle Activation After Perinatal Brachial Plexus Injury: A Pilot Study.

PubMed

Duff, S V; Sargent, B; Kutch, J J; Berggren, J; Leiby, B E; Fetters, L

2017-10-20

Examine the feasibility of increasing muscle activation with electromyographically (EMG)-triggered musical-video as reinforcement for children with perinatal brachial plexus injury (PBPI). Six children with PBPI (9.3 ± 6.3 months; 5 female, 1 male) and 13 typically developing (TD) controls (7.8 ± 3.5 months; 4 female, 9 males) participated. The left arm was affected in 5/6 children with PBPI. We recorded the integral (Vs) of biceps activation with surface EMG during two conditions per arm in one session: (1) 100 second (s) baseline without reinforcement and (2) 300 s reinforcement (musical-video triggered to play with biceps activation above threshold [V]). We examined the relation between the mean integral with reinforcement and hand preference. Mean biceps activation significantly increased from baseline in the affected arm of the group with PBPI by the 2nd (p < .008) and 3rd (p < .0004) 100 s intervals of reinforcement. Six of 6 children with PBPI and 12/13 TD controls increased activation in at least one arm. A lower integral was linked with hand preference for the unaffected right side in the PBPI group. This study supports contingent reinforcement as a feasible method to increase muscle activation. Future work will examine training dose and intensity to increase arm function.

Goal-setting intervention in patients with active asthma: protocol for a pilot cluster-randomised controlled trial

PubMed Central

2013-01-01

Background Supporting self-management behaviours is recommended guidance for people with asthma. Preliminary work suggests that a brief, intensive, patient-centred intervention may be successful in supporting people with asthma to participate in life roles and activities they value. We seek to assess the feasibility of undertaking a cluster-randomised controlled trial (cRCT) of a brief, goal-setting intervention delivered in the context of an asthma review consultation. Methods/design A two armed, single-blinded, multi-centre, cluster-randomised controlled feasibility trial will be conducted in UK primary care. Randomisation will take place at the practice level. We aim to recruit a total of 80 primary care patients with active asthma from at least eight practices across two health boards in Scotland (10 patients per practice resulting in ~40 in each arm). Patients in the intervention arm will be asked to complete a novel goal-setting tool immediately prior to an asthma review consultation. This will be used to underpin a focussed discussion about their goals during the asthma review. A tailored management plan will then be negotiated to facilitate achieving their prioritised goals. Patients in the control arm will receive a usual care guideline-based review of asthma. Data on quality of life, asthma control and patient confidence will be collected from both arms at baseline and 3 and 6 months post-intervention. Data on health services resource use will be collected from all patient records 6 months pre- and post-intervention. Semi-structured interviews will be carried out with healthcare staff and a purposive sample of patients to elicit their views and experiences of the trial. The outcomes of interest in this feasibility trial are the ability to recruit patients and healthcare staff, the optimal method of delivering the intervention within routine clinical practice, and acceptability and perceived utility of the intervention among patients and staff. Trial registration ISRCTN18912042 PMID:24021033

Systematic Review of Integrative Health Care Research: Randomized Control Trials, Clinical Controlled Trials, and Meta-Analysis

DTIC Science & Technology

2010-01-01

to usual care (control). Also, in the pilot study of the 4 individual Noetic therapies, off-site prayer was associated with the lowest absolute...mortality in-hospital and at 6 months [16]. The parallel randomization to 4 different Noetic therapies across 5 study arms limited the assessment of...interventional cardiac care: the Monitoring and Actualisation of Noetic Trainings (MANTRA) II randomised study ,” Lancet, vol. 366, no. 9481, pp. 211–217, 2005. [18

Evaluation of the Risk for Work-Related Upper Extremity Musculoskeletal Symptoms in USAF Air Traffic Controllers: A Pilot Feasibility Study

DTIC Science & Technology

1997-07-11

interest to this study. One was suffering from (being diagnosed and in treatment for) medial epicondylitis , and the other had tenderness related to...rest forearms and hands, excessive lateral deviation of the hands operating the keyboard, and a pronounced inclination or turning of the head. Their...equal to or greater than 2.0. A similar relative risk was noted for neck, shoulder, arm and elbow disorders in 9 of 16 studies. The magnitude of the

Combined rTMS treatment targeting the Anterior Cingulate and the Temporal Cortex for the Treatment of Chronic Tinnitus

PubMed Central

Kreuzer, Peter M.; Lehner, Astrid; Schlee, Winfried; Vielsmeier, Veronika; Schecklmann, Martin; Poeppl, Timm B.; Landgrebe, Michael; Rupprecht, Rainer; Langguth, Berthold

2015-01-01

Repetitive transcranial magnetic stimulation (rTMS) has been proposed as a tinnitus treatment option. Promising results have been obtained by consecutive stimulation of lateral frontal and auditory brain regions. We investigated a combined stimulation paradigm targeting the anterior cingulate cortex (ACC) with double cone coil rTMS, followed by stimulation of the temporo-parietal junction area with a figure-of-eight coil. The study was conducted as a randomized, double-blind pilot trial in 40 patients suffering from chronic tinnitus. We compared mediofrontal stimulation with double-cone-coil, (2000 stimuli, 10 Hz) followed by left temporo-parietal stimulation with figure-of-eight-coil (2000 stimuli, 1 Hz) to left dorsolateral-prefrontal-cortex stimulation with figure-of-eight-coil (2000 stimuli, 10 Hz) followed by temporo-parietal stimulation with figure-of-eight-coil (2000 stimuli, 1 Hz). The stimulation was feasible with comparable dropout rates in both study arms; no severe adverse events were registered. Responder rates did not differ in both study arms. There was a significant main effect of time for the change in the TQ score, but no significant time x group interaction. This pilot study demonstrated the feasibility of combined mediofrontal/temporoparietal-rTMS-stimulation with double cone coil in tinnitus patients but failed to show better outcome compared to an actively rTMS treated control group. PMID:26667790

Special Features of the Structure of Single-Crystal Refractory Nickel Alloy Under Directed Crystallization

NASA Astrophysics Data System (ADS)

Bondarenko, Yu. A.; Echin, A. B.; Surova, V. A.; Kolodyazhnyi, M. Yu.

2017-05-01

The effect of the conditions of directed crystallization (the temperature gradient and the crystallization rate) on the dendrite spacing, on the size of the particles of the hardening γ'-phase in the arms and arm spaces of the dendrites, on the volume fraction and size of the pores, on the size of the particles of the eutectic γ/γ'-phase, and on the features of dendritic segregation in a single-crystal castable refractory alloy is studied.

ACTG A5353: A Pilot Study of Dolutegravir Plus Lamivudine for Initial Treatment of Human Immunodeficiency Virus-1 (HIV-1)-infected Participants With HIV-1 RNA <500000 Copies/mL.

PubMed

Taiwo, Babafemi O; Zheng, Lu; Stefanescu, Andrei; Nyaku, Amesika; Bezins, Baiba; Wallis, Carole L; Godfrey, Catherine; Sax, Paul E; Acosta, Edward; Haas, David; Smith, Kimberly Y; Sha, Beverly; Van Dam, Cornelius; Gulick, Roy M

2018-05-17

Limited data exist on initial human immunodeficiency virus type 1 (HIV-1) treatment with dolutegravir plus lamivudine. A5353 is a phase 2, single-arm, pilot study of once-daily dolutegravir (50 mg) plus lamivudine (300 mg) in treatment-naive participants with HIV-1 RNA ≥1000 and <500000 copies/mL. Exclusion criteria included active hepatitis B or major protease, reverse transcriptase, or integrase resistance. The primary efficacy measure was the proportion with HIV-1 RNA <50 copies/mL (FDA [US Food and Drug Administration] Snapshot) at week 24. Virologic failure (VF) was confirmed HIV-1 RNA >400 copies/mL at week 16/20 or >200 copies/mL at or after week 24. Dolutegravir levels and drug resistance testing were performed at VF. One hundred and twenty participants (87% male, median age 30 years, 37 (31%) HIV-1 RNA >100000 copies/mL) initiated study treatment. Median entry HIV-1 RNA and CD4 count were 4.61 log10 copies/mL and 387 cells/mm3. Virologic efficacy at week 24 was 108/120 (90%, confidence interval [83%, 95%]), with comparable results in the >100000 copies/mL and ≤100000 copies/mL strata, that is, 89% (75%, 97%) and 90% (82%, 96%), respectively. Three participants with VF, had undetected plasma dolutegravir at ≥1 time points; the M184V and R263R/K mutations developed in 1 participant. Two participants experienced grade 3 possible/probable treatment-related adverse events; none discontinued treatment due to adverse events. Dolutegravir plus lamivudine demonstrated efficacy in individuals with pretreatment HIV-1 RNA up to 500000 copies/mL in this pilot trial, but a participant developed resistance mutations. NCT02582684.

Radiotherapy Does Not Influence the Severe Pulmonary Toxicity Observed With the Administration of Gemcitabine and Bleomycin in Patients With Advanced-Stage Hodgkin's Lymphoma Treated With the BAGCOPP Regimen: A Report by the German Hodgkin's Lymphoma Study Group

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

Macann, Andrew; Bredenfeld, Henning; Mueller, Rolf-Peter

2008-01-01

Purpose: To evaluate the effect of radiotherapy on the severe pulmonary toxicity observed in the pilot study of BAGCOPP (bleomycin, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone, and gemcitabine) for advanced-stage Hodgkin's lymphoma. Methods and Materials: Patients with Stage III or IV Hodgkin's lymphoma or Stage IIB with risk factors participated in this single-arm, multicenter pilot study. Results: Twenty-seven patients were enrolled on the study before its premature closure as a result of the development of serious pulmonary toxicity in 8 patients. The pulmonary toxicity occurred either during or immediately after the BAGCOPP chemotherapy course. Pulmonary toxicity contributed to one early fatalitymore » but resolved in the other 7 patients after cessation of gemcitabine and bleomycin, allowing continuation of therapy. Fifteen patients received consolidative radiotherapy, including 4 who previously had pulmonary toxicity. There were no reported cases of radiation pneumonitis and no exacerbation of pulmonary symptoms in the 4 patients who had had previous pulmonary toxicity. Conclusions: The severe pulmonary toxicity observed in this study has been attributed to an interaction between gemcitabine and bleomycin. Gemcitabine (when administered without bleomycin) remains of interest in Hodgkin's lymphoma and is being incorporated into a new German Hodgkin's Lymphoma Study Group protocol that also includes consolidative radiotherapy. This study supports the concept of the integration of radiotherapy in gemcitabine-containing regimens in Hodgkin's lymphoma if there is an interval of at least 4 weeks between the two modalities and with a schedule whereby radiotherapy follows the chemotherapy.« less

Group vs. Individual Treatment for Acute Insomnia: A Pilot Study Evaluating a "One-Shot" Treatment Strategy.

PubMed

Boullin, Pam; Ellwood, Christina; Ellis, Jason G

2016-12-23

Despite undeniable evidence for the efficacy and effectiveness of Cognitive Behaviour Therapy for Insomnia (CBT-I), the potential for its widespread dissemination and implementation has yet to be realised. A suggested reason for this is that traditional CBT-I is considered too burdensome for deployment, in its current form, within the context of where it would be most beneficial-Primary Care. One strategy, aimed to address this, has been to develop briefer versions of CBT-I, whilst another has been to deliver CBT-I in a group format. An alternative has been to attempt to address insomnia during its acute phase with a view to circumventing its progression to chronic insomnia. The aim of the present study was to compare a brief version of CBT-I (one-shot) when delivered individually or in groups to those with acute insomnia. Twenty-eight individuals with acute insomnia (i.e., meeting full DSM-5 criteria for insomnia disorder for less than three months) self-assigned to either a group or individual treatment arm. Treatment consisted of a single one-hour session accompanied by a self-help pamphlet. Subjects completed measures of insomnia severity, anxiety and depression pre-treatment and at one-month post-treatment. Additionally, daily sleep diaries were compared between pre-treatment and at the one-month follow up. There were no significant between group differences in treatment outcome on any sleep or mood measures although those in the group treatment arm were less adherent than those who received individual treatment. Furthermore, the combined (group and individual treatment arms) pre-post test effect size on insomnia symptoms, using the Insomnia Severity Index, was large ( d = 2.27). It appears that group treatment is as efficacious as individual treatment within the context of a "one shot" intervention for individuals with acute insomnia. The results are discussed with a view to integrating one-shot CBT-I in Primary Care.

[Multiple-Victimisation due to Armed Conflict and Emotional Distress in the State of Magdalena, Colombia].

PubMed

Campo-Arias, Adalberto; Sanabria, Adriana R; Ospino, Anyelly; Guerra, Valeria M; Caamaño, Beatriz H

Emotional distress is common in Colombian armed conflict victims. Multiple-victimisation is associated with an increase in emotional distress than victimisation due a single event. However, the association between poly-victimisation and emotional distress among victims of the armed conflict in Colombia has not been documented. To study the association between multiple-victimisation and emotional distress in victims of armed conflict in the State of Magdalena, Colombia. A cross-sectional study was designed, with a secondary analysis of registration of the Psychosocial Care Program and Victim Integral Health (PAPSIVI) in the State of Magdalena, from 2013 to 2014. The profile formula grouped demographic variables, victimising events, and a set of symptoms of emotional distress (perceived discrimination, depressive and anxiety-stress). Odds ratio (OR, 95%CI) were established as measures of association. A total of 943 people were included, with 67.4% women, and ages between18 and 94 years (mean 47.9±14.2). A total of 109 (11.7%) suffered from multiple victimisation. Multiple victimisation events were associated with more emotional distress, depressive symptoms (OR=1.5; 95%CI, 1.3-1.8), perceived stigma (OR=1.3; 95%CI, 1.1-1.5), and anxiety-stress (OR=1.2; 95%CI 1.0-1.4) than a single event. There is more emotional distress in multiple victimisations than in a single victimisation event during armed conflict in this region of Colombia. Further studies are required on this topic. Copyright © 2016 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

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

ERIC Educational Resources Information Center

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

2016-01-01

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

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.

Efficacy and safety of oral alitretinoin in severe oral lichen planus--results of a prospective pilot study.

PubMed

Kunz, M; Urosevic-Maiwald, M; Goldinger, S M; Frauchiger, A L; Dreier, J; Belloni, B; Mangana, J; Jenni, D; Dippel, M; Cozzio, A; Guenova, E; Kamarachev, J; French, L E; Dummer, R

2016-02-01

Patients with severe oral lichen planus refractory to standard topical treatment currently have limited options of therapy suitable for long-term use. Oral alitretinoin (9-cis retinoic acid) was never systematically investigated in clinical trials, although case reports suggest its possible efficacy. To assess the efficacy and safety of oral alitretinoin taken at 30 mg once daily for up to 24 weeks in the treatment of severe oral lichen planus refractory to standard topical therapy. We conducted a prospective open-label single arm pilot study to test the efficacy and safety of 30 mg oral alitretinoin once daily for up to 24 weeks in severe oral lichen planus. Ten patients were included in the study. Primary end point was reduction in signs and symptoms measured by the Escudier severity score. Secondary parameters included pain and quality of life scores. Safety parameters were assessed during a follow-up period of 5 weeks. A substantial response at the end of treatment, i.e. >50% reduction in disease severity measured by the Escudier severity score, was apparent in 40% of patients. Therapy was well tolerated. Adverse events were mild and included headache, mucocutaneous dryness, musculoskeletal pain, increased thyroid-stimulating hormone and dyslipidaemia. Alitretinoin given at 30 mg daily reduced disease severity of severe oral lichen planus in a substantial proportion of patients refractory to standard treatment, was well tolerated and may thus represent one therapeutic option for this special group of patients. © 2015 European Academy of Dermatology and Venereology.

Pilot study: whole body manual subcutaneous adipose tissue (SAT) therapy improved pain and SAT structure in women with lipedema.

PubMed

Herbst, Karen L; Ussery, Christopher; Eekema, Alyna

2017-09-20

Background Lipedema is a common painful subcutaneous adipose tissue (SAT) disorder in women affecting the limbs. SAT therapy is a manual therapy to improve soft tissue quality. Objective Determine if SAT therapy improves pain and structure of lipedema SAT. Design Single arm prospective pilot study. Setting Academic medical center. Patients Seven women, 46 ± 5 years, weight 90 ± 19 kg, with lipedema. Intervention Twelve 90-min SAT therapy sessions over 4 weeks. Outcomes Dual X-ray absorptiometry (DXA) scans, SAT ultrasound (Vevo 2100), leg volumetrics, skin caliper assessment, tissue exam, weight, resting metabolic rate, pain assessment, lower extremity functional scale (LEFS) and body shape questionnaire (BSQ) at baseline and end of study. Results Weight, resting metabolic rate and BSQ did not change significantly. Limb fat over total body fat mass (p = 0.08) and trunk fat over total body mass trended down from baseline (p = 0.08) by DXA. Leg volume and caliper assessments in eight of nine areas (p < 0.007), LEFS (p = 0.002) and average pain (p = 0.007) significantly decreased from baseline. Fibrosis significantly decreased in the nodules, hips and groin. Ultrasound showed improved SAT structure in some subjects. Side effects included pain, bruising, itching, swelling and gastroesophageal reflux disease. All women said they would recommend SAT therapy to other women with lipedema. Limitations Small number of subjects. Conclusion SAT therapy in 4 weeks improved tissue structure, perceived leg function, and volume although shape was not affected. While side effects of SAT therapy were common, all women felt the therapy was beneficial.

Effect of task-based mirror therapy on motor recovery of the upper extremity in chronic stroke patients: a pilot study.

PubMed

Arya, Kamal Narayan; Pandian, Shanta

2013-01-01

Mirror therapy (MT) is an alternative therapeutic intervention that uses the interaction of visuomotor-proprioception inputs to enhance movement performance of the impaired limb. Despite strong evidence for task-specific training in stroke, MT has been investigated using nontask movements. The aim of this pilot study was to assess the effectiveness of task-based MT on motor recovery of the upper extremity in chronic stroke patients. In a pretest-posttest single-group design, a convenience sample of 13 chronic stroke patients at an occupational therapy department of a rehabilitation institute was assessed on a task-based MT intervention. Participants received a task-based MT program, performing various tasks by the less affected upper extremity and observing in the mirror box along with conventional management, 4 days per week for 4 weeks. Fugl-Meyer Assessment (FMA), which includes subsection upper extremity (FMA-UE) and subpart upper arm (FMA-UA) and hand (FMA-WH), was used as an outcome measure. Participants showed no significant improvement for FMA-UE and FMA-UA at postassessment. FMA-UE changed from 43% to 51%. Post FMA-UA score showed only 2% improvement. However, there was statistically significant improvement on mean scores of FMA-WH at postassessment (16.21 ± 3.06) as compared with the prescores (12.29 ± 3.1; P < .05). FMA-WH improved from 41% to 54%. The preliminary findings suggest that task-based MT is effective in improving wrist and hand motor recovery in chronic stroke patients. Further studies in the form of randomized trials are needed to validate its effectiveness.

Laboratory Performance of the Single-Sided E-A-R (registered trademark) Combat Arms Hearing Protective Earplug

DTIC Science & Technology

2010-01-01

mdividu a eté evalue sans protection auditive ctaye.c port. binaural du protecteur dans chacun des deux modes. Les seuils auditifs en champ hbre...which the ears were: unocciuded (Unocelud), fitted binaurally with the single- sided version of the Combat Arms earplug in the steady state noise mode...CAE SS), and fitted binaurally with the single-sided version of the Combat Arms earplug in the weapons fire mode (CAE WF). The unoccluded condition was

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

NASA Technical Reports Server (NTRS)

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

1988-01-01

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

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.

A limit-cycle self-organizing map architecture for stable arm control.

PubMed

Huang, Di-Wei; Gentili, Rodolphe J; Katz, Garrett E; Reggia, James A

2017-01-01

Inspired by the oscillatory nature of cerebral cortex activity, we recently proposed and studied self-organizing maps (SOMs) based on limit cycle neural activity in an attempt to improve the information efficiency and robustness of conventional single-node, single-pattern representations. Here we explore for the first time the use of limit cycle SOMs to build a neural architecture that controls a robotic arm by solving inverse kinematics in reach-and-hold tasks. This multi-map architecture integrates open-loop and closed-loop controls that learn to self-organize oscillatory neural representations and to harness non-fixed-point neural activity even for fixed-point arm reaching tasks. We show through computer simulations that our architecture generalizes well, achieves accurate, fast, and smooth arm movements, and is robust in the face of arm perturbations, map damage, and variations of internal timing parameters controlling the flow of activity. A robotic implementation is evaluated successfully without further training, demonstrating for the first time that limit cycle maps can control a physical robot arm. We conclude that architectures based on limit cycle maps can be organized to function effectively as neural controllers. Copyright © 2016 Elsevier Ltd. All rights reserved.

Flying Qualities Design Requirements for Sidestick Controllers

DTIC Science & Technology

1979-10-01

Harper vs wc - Fine Tracking 111 56. Cooper-Harper vs wc - Fine Tracking 111 57. Cooper-Harper ve wc - Landing 112 58. Cooper-Harper vs wc - Lending 112...c - Fine Tracking 119 62. Preference Rating vs wc - Fine Tracking 119 64. Preference Rating vs wc - Landing 120 65. Preference Rating vs w(c...a "fast airplane" to make up for the filtering effect of his arm and the stick. In fine tracking with a center stick the pilot will rest his arm

Development Test 1 Advanced Attack Helicopter Competitive Evaluation Hughes YAH-64 Helicopter

DTIC Science & Technology

1976-12-01

pilot or the copilot/gunner. The gun/rocket firing circuits were armed by selecting either guns or rockets on the armament panel (fig. 36, app B). The...number of 30mm rounds to be fired and gun barrel positions could only be set from the gunner position for DT I testing. Once the systems were armed ...fuselage is of a semimonocoque construction of primarily aluminum alloys. It consists of 10 major bulkheads and frames and 8 major longerons and

Can an electronic device with a single cuff be accurate in a wide range of arm size? Validation of the Visomat Comfort 20/40 device for home blood pressure monitoring.

PubMed

Stergiou, G S; Tzamouranis, D; Nasothimiou, E G; Protogerou, A D

2008-11-01

An appropriate cuff according to the individual's arm circumference is recommended with all blood pressure (BP) monitors. An electronic device for home monitoring has been developed (Visomat Comfort 20/40) that estimates the individual's arm circumference by measuring the cuff filing volume and makes an adjustment of measured BP taking into account the estimated arm circumference. Thus the manufacturer recommends the use of a single cuff for arm circumference 23-43 cm. The device accuracy was assessed using the European Society of Hypertension International Protocol. Simultaneous BP measurements were obtained in 33 adults by two observers (connected mercury sphygmomanometers) four times, sequentially with three measurements taken using the tested device. Absolute device-observer BP differences were classified into < or =5, < or =10 and < or =15 mm Hg zones. For each participant the number of measurements with a difference < or =5 mm Hg was calculated. The device produced 60/89/97 measurements within 5/10/15 mm Hg respectively for systolic BP, and 72/97/98 for diastolic. Twenty-three subjects had at least two of their systolic BP differences < or =5 mm Hg and three had no differences < or =5 mm Hg (for diastolic 27 and 1, respectively). Mean device-observer BP difference (systolic/diastolic) was 3.7 +/- 5.6/-1.5 +/- 4.7 mm Hg (4.7 +/- 4.9/ - 1.7 +/- 4.3 in arm circumference 23-29 cm [39 readings] and 3.1 +/- 5.9/-1.4 +/- 5.0 in arm 30-34 cm [60 readings], P=NS). In conclusion, the device fulfils the International Protocol requirements and can be recommended for clinical use. Interestingly, the device was accurate using a single cuff in a wide range of arm circumference (23-34 cm). This study provides no information about the device accuracy in larger arms.

Lean stability augmentation study. [on gas turbine combustion chambers

NASA Technical Reports Server (NTRS)

Mcvey, J. B.; Kennedy, J. B.

1979-01-01

An analytical conceptual design study and an experimental test program were conducted to investigate techniques and develop technology for improving the lean combustion limits of premixing, prevaporizing combustors applicable to gas turbine engine main burners. The use of hot gas pilots, catalyzed flameholder elements, and heat recirculation to augment lean stability limits was considered in the conceptual design study. Tests of flameholders embodying selected concepts were conducted at a pressure of 10 arm and over a range of entrance temperatures simulating conditions to be encountered during stratospheric cruise. The tests were performed using an axisymmetric flametube test rig having a nominal diameter of 10.2 cm. A total of sixteen test configurations were examined in which lean blowout limits, pollutant emission characteristics, and combustor performance were evaluated. The use of a piloted perforated plate flameholder employing a pilot fuel flow rate equivalent to 4 percent of the total fuel flow at a simulated cruise condition resulted in a lean blowout equivalence ratio of less than 0.25 with a design point (T sub zero = 600k, Phi = 0.6) NOx emission index of less than 1.0 g/kg.

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

NASA Technical Reports Server (NTRS)

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

2010-01-01

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

Ankle Training With a Robotic Device Improves Hemiparetic Gait After a Stroke

PubMed Central

Forrester, Larry W.; Roy, Anindo; Krebs, Hermano Igo; Macko, Richard F.

2013-01-01

Background Task-oriented therapies such as treadmill exercise can improve gait velocity after stroke, but slow velocities and abnormal gait patterns often persist, suggesting a need for additional strategies to improve walking. Objectives To determine the effects of a 6-week visually guided, impedance controlled, ankle robotics intervention on paretic ankle motor control and gait function in chronic stroke. Methods This was a single-arm pilot study with a convenience sample of 8 stroke survivors with chronic hemiparetic gait, trained and tested in a laboratory. Subjects trained in dorsiflexion–plantarflexion by playing video games with the robot during three 1-hour training sessions weekly, totaling 560 repetitions per session. Assessments included paretic ankle ranges of motion, strength, motor control, and overground gait function. Results Improved paretic ankle motor control was seen as increased target success, along with faster and smoother movements. Walking velocity also increased significantly, whereas durations of paretic single support increased and double support decreased. Conclusions Robotic feedback training improved paretic ankle motor control with improvements in floor walking. Increased walking speeds were comparable with reports from other task-oriented, locomotor training approaches used in stroke, suggesting that a focus on ankle motor control may provide a valuable adjunct to locomotor therapies. PMID:21115945

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 Doe Water Cycle Pilot Study.

NASA Astrophysics Data System (ADS)

Miller, N. L.; King, A. W.; Miller, M. A.; Springer, E. P.; Wesely, M. L.; Bashford, K. E.; Conrad, M. E.; Costigan, K.; Foster, P. N.; Gibbs, H. K.; Jin, J.; Klazura, J.; Lesht, B. M.; Machavaram, M. V.; Pan, F.; Song, J.; Troyan, D.; Washington-Allen, R. A.

2005-03-01

A Department of Energy (DOE) multilaboratory Water Cycle Pilot Study (WCPS) investigated components of the local water budget at the Walnut River watershed in Kansas to study the relative importance of various processes and to determine the feasibility of observational water budget closure. An extensive database of local meteorological time series and land surface characteristics was compiled. Numerical simulations of water budget components were generated and, to the extent possible, validated for three nested domains within the Southern Great Plains-the Department of Energy (DOE) Atmospheric Radiation Measurement (ARM) Cloud Atmospheric Radiation Testbed (CART), the Walnut River watershed (WRW), and the Whitewater watershed (WW), in Kansas.A 2-month intensive observation period (IOP) was conducted to gather extensive observations relevant to specific details of the water budget, including finescale precipitation, streamflow, and soil moisture measurements that were not made routinely by other programs. Event and seasonal water isotope (d18O, dD) sampling in rainwater, streams, soils, lakes, and wells provided a means of tracing sources and sinks within and external to the WW, WRW, and the ARM CART domains. The WCPS measured changes in the leaf area index for several vegetation types, deep groundwater variations at two wells, and meteorological variables at a number of sites in the WRW. Additional activities of the WCPS include code development toward a regional climate model that includes water isotope processes, soil moisture transect measurements, and water-level measurements in groundwater wells.

Constraint-Induced Therapy Combined with Conventional Neurorehabilitation Techniques in Chronic Stroke Patients with Plegic Hands: A Case Series

PubMed Central

Taub, Edward; Uswatte, Gitendra; Bowman, Mary H.; Mark, Victor W.; Delgado, Adriana; Bryson, Camille; Morris, David; Bishop-McKay, Staci

2012-01-01

Objective To determine in this pilot study whether the combination of CI therapy and conventional rehabilitation techniques can produce meaningful motor improvement in chronic stroke patients with initially fisted hands. In the past, limited success has been achieved using CI therapy alone for stroke patients with plegic hands. Design Case series Setting University hospital outpatient laboratory Participants Consecutive sample of 6 patients > 1 yr post-stroke with plegic hands Interventions Treatment consisted of an initial period of 3 weeks (Phase A) when adaptive equipment in the home, orthotics and splints were employed to improve ability to engage in activities of daily living. This was continued in Phase B, when CI therapy along with selected neurodevelopmental treatment techniques were added. Main Outcome Measures Motor Activity Log (MAL), accelerometry, Fugl-Meyer Motor Assessment (F-M) Results Patients exhibited a large improvement in spontaneous real-world use of the more-affected arm (mean lower-functioning MAL change = 1.3±0.4 points, P <0.001, d′ = 3.0), and a similar pattern of increase in an objective measure of real-world more-affected arm movement (mean change in ratio of more- to less-affected arm accelerometer recordings = 0.12±0.1 points, P = 0.016 d′ = 1.2). A large improvement in motor status was also recorded (mean F-M change = 5.3±3.3 points, P = 0.005, d′ = 1.6). Conclusions The findings of this pilot study suggest that stroke patients with plegic hands can benefit from CI therapy combined with some conventional rehabilitation techniques, even long after brain injury. More research is warranted. PMID:22922823

Robot training of upper limb in multiple sclerosis: comparing protocols with or without manipulative task components.

PubMed

Carpinella, Ilaria; Cattaneo, Davide; Bertoni, Rita; Ferrarin, Maurizio

2012-05-01

In this pilot study, we compared two protocols for robot-based rehabilitation of upper limb in multiple sclerosis (MS): a protocol involving reaching tasks (RT) requiring arm transport only and a protocol requiring both objects' reaching and manipulation (RMT). Twenty-two MS subjects were assigned to RT or RMT group. Both protocols consisted of eight sessions. During RT training, subjects moved the handle of a planar robotic manipulandum toward circular targets displayed on a screen. RMT protocol required patients to reach and manipulate real objects, by moving the robotic arm equipped with a handle which left the hand free for distal tasks. In both trainings, the robot generated resistive and perturbing forces. Subjects were evaluated with clinical and instrumental tests. The results confirmed that MS patients maintained the ability to adapt to the robot-generated forces and that the rate of motor learning increased across sessions. Robot-therapy significantly reduced arm tremor and improved arm kinematics and functional ability. Compared to RT, RMT protocol induced a significantly larger improvement in movements involving grasp (improvement in Grasp ARAT sub-score: RMT 77.4%, RT 29.5%, p=0.035) but not precision grip. Future studies are needed to evaluate if longer trainings and the use of robotic handles would significantly improve also fine manipulation.

Exercise effect with the wheelchair aerobic fitness trainer on conditioning and metabolic function in disabled persons: a pilot study.

PubMed

Midha, M; Schmitt, J K; Sclater, M

1999-03-01

To determine the effect of exercise with the wheelchair aerobic fitness trainer (WAFT) on anthropometric indices, conditioning, and endocrine and metabolic parameters in persons with lower extremity disability. Exercise sessions with the WAFT lasted 20 to 30 minutes for two to three sessions. Tertiary-care Veterans Administration medical center. Twelve subjects (3 with quadriplegia, 7 with paraplegia, 1 with cerebrovascular accident, 1 with bilateral above-knee amputation). Anthropometric indices (heart rate, blood pressure, weight, oxygen utilization, body mass index, upper arm and abdominal circumference, arm power) and endocrine and metabolic parameters (fasting serum glucose, lipids, and thyroid function) were determined before and after 10 weeks of exercise with the WAFT. All patients noted improved feelings of well-being after training. Mean resting heart rate, upper arm fat area, and fasting serum cholesterol level decreased significantly. Peak oxygen consumption, midarm circumference, and free thyroxine index increased significantly with training. WAFT improves quality of life, conditioning, and endocrine-metabolic parameters in disabled persons.

Atmospheric radiation measurement unmanned aerospace vehicle (ARM-UAV) program

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

Bolton, W.R.

1996-11-01

ARM-UAV is part of the multi-agency U.S. Global Change Research Program and is addressing the largest source of uncertainty in predicting climatic response: the interaction of clouds and the sun`s energy in the Earth`s atmosphere. An important aspect of the program is the use of unmanned aerospace vehicles (UAVs) as the primary airborne platform. The ARM-UAV Program has completed two major flight series: The first series conducted in April, 1994, using an existing UAV (the General Atomics Gnat 750) consisted of eight highly successful flights at the DOE climate site in Oklahoma. The second series conducted in September/October, 1995, usingmore » two piloted aircraft (Egrett and Twin Otter), featured simultaneous measurements above and below clouds and in clear sky. Additional flight series are planned to continue study of the cloudy and clear sky energy budget in the Spring and Fall of 1996 over the DOE climate site in Oklahoma. 3 refs., 4 figs., 1 tab.« less

Decoding complete reach and grasp actions from local primary motor cortex populations.

PubMed

Vargas-Irwin, Carlos E; Shakhnarovich, Gregory; Yadollahpour, Payman; Mislow, John M K; Black, Michael J; Donoghue, John P

2010-07-21

How the activity of populations of cortical neurons generates coordinated multijoint actions of the arm, wrist, and hand is poorly understood. This study combined multielectrode recording techniques with full arm motion capture to relate neural activity in primary motor cortex (M1) of macaques (Macaca mulatta) to arm, wrist, and hand postures during movement. We find that the firing rate of individual M1 neurons is typically modulated by the kinematics of multiple joints and that small, local ensembles of M1 neurons contain sufficient information to reconstruct 25 measured joint angles (representing an estimated 10 functionally independent degrees of freedom). Beyond showing that the spiking patterns of local M1 ensembles represent a rich set of naturalistic movements involving the entire upper limb, the results also suggest that achieving high-dimensional reach and grasp actions with neuroprosthetic devices may be possible using small intracortical arrays like those already being tested in human pilot clinical trials.

Quantitative assessment of arm tremor in people with neurological disorders.

PubMed

Jeonghee Kim; Parnell, Claire; Wichmann, Thomas; DeWeerth, Stephen P

2016-08-01

Abnormal oscillatory movement (i.e. tremor) is usually evaluated with qualitative assessment by clinicians, and quantified with subjective scoring methods. These methods are often inaccurate. We utilized a quantitative and standardized task based on the Fitts' law to assess the performance of arm movement with tremor by controlling a gyration mouse on a computer. The experiment included the center-out tapping (COT) and rectangular track navigation (RTN) tasks. We report the results of a pilot study in which we collected the performance for healthy participants in whom tremor was simulated by imposing oscillatory movements to the arm with a vibration motor. We compared their movement speed and accuracy with and without the artificial "tremor." We found that the artificial tremor significantly affected the path efficiency for both tasks (COT: 56.8 vs. 46.2%, p <; 0.05; RTN: 94.2 vs. 67.4%, p <; 0.05), and we were able to distinguish the presence of tremor. From this result, we expect to quantify severity of tremor and the effectiveness therapy for tremor patients.

The Development of a Web-Based Program to Reduce Dietary Salt Intake in Schoolchildren: Study Protocol.

PubMed

Grimes, Carley Ann; Booth, Alison; Khokhar, Durreajam; West, Madeline; Margerison, Claire; Campbell, Karen; Nowson, Caryl

2017-05-31

Salt intake of schoolchildren in the Australian state of Victoria is high. To protect future cardiovascular health, interventions that seek to reduce the amount of salt in children's diets are required. We sought to develop and pilot test a Web-based program (Digital Education to Limit Salt Intake in the Home [DELISH]) that aims to reduce dietary salt intake among schoolchildren and to improve child and parent knowledge, attitudes, and behaviors related to salt intake. This paper presents the DELISH study protocol, along with pilot findings used to inform the development of the program. The DELISH program is a 5-week Web-based intervention that targets schoolchildren aged 7-10 years and their parents. This is a single-arm study with a pretest and posttest design. We will assess change in salt intake through analysis of 24-hour urinary sodium excretion. Children and parents will complete online surveys assessing knowledge, attitudes, and behaviors related to salt intake. We will assess feasibility of the program via process measures, which include metrics to describe intervention uptake (eg, number of children who complete Web-based sessions and of parents who view online newsletters) and evaluation surveys and interviews conducted with children, parents, and schoolteachers. The first 2 Web sessions developed for children were pilot tested in 19 children aged 8-12 years. Findings from pilot testing indicated that most children (session 1: 18/19, 95%; and session 2: 19/19, 100%) enjoyed completing each session and liked the inclusion of comic strips and interactive games. Commonly reported areas of improvement related to sessions being text and content heavy. Based on these findings, we simplified sessions and developed 3 additional sessions for use in the DELISH program. The DELISH program was implemented during June-December 2016. We expect to have results from this study at the end of 2017. To our knowledge, this is the first Australian study to examine the effectiveness of a Web-based program to reduce salt intake among children in primary school. If shown to be acceptable and effective in lowering salt intake, the DELISH program could be tested using a more rigorous randomized controlled trial design. ©Carley Ann Grimes, Alison Booth, Durreajam Khokhar, Madeline West, Claire Margerison, Karen Campbell, Caryl Nowson. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 31.05.2017.

The Development of a Web-Based Program to Reduce Dietary Salt Intake in Schoolchildren: Study Protocol

PubMed Central

Booth, Alison; Khokhar, Durreajam; West, Madeline; Margerison, Claire; Campbell, Karen; Nowson, Caryl

2017-01-01

Background Salt intake of schoolchildren in the Australian state of Victoria is high. To protect future cardiovascular health, interventions that seek to reduce the amount of salt in children’s diets are required. Objective We sought to develop and pilot test a Web-based program (Digital Education to Limit Salt Intake in the Home [DELISH]) that aims to reduce dietary salt intake among schoolchildren and to improve child and parent knowledge, attitudes, and behaviors related to salt intake. This paper presents the DELISH study protocol, along with pilot findings used to inform the development of the program. Methods The DELISH program is a 5-week Web-based intervention that targets schoolchildren aged 7-10 years and their parents. This is a single-arm study with a pretest and posttest design. We will assess change in salt intake through analysis of 24-hour urinary sodium excretion. Children and parents will complete online surveys assessing knowledge, attitudes, and behaviors related to salt intake. We will assess feasibility of the program via process measures, which include metrics to describe intervention uptake (eg, number of children who complete Web-based sessions and of parents who view online newsletters) and evaluation surveys and interviews conducted with children, parents, and schoolteachers. The first 2 Web sessions developed for children were pilot tested in 19 children aged 8-12 years. Results Findings from pilot testing indicated that most children (session 1: 18/19, 95%; and session 2: 19/19, 100%) enjoyed completing each session and liked the inclusion of comic strips and interactive games. Commonly reported areas of improvement related to sessions being text and content heavy. Based on these findings, we simplified sessions and developed 3 additional sessions for use in the DELISH program. The DELISH program was implemented during June-December 2016. We expect to have results from this study at the end of 2017. Conclusions To our knowledge, this is the first Australian study to examine the effectiveness of a Web-based program to reduce salt intake among children in primary school. If shown to be acceptable and effective in lowering salt intake, the DELISH program could be tested using a more rigorous randomized controlled trial design. PMID:28566266

N-Acetylcysteine for Nonsuicidal Self-Injurious Behavior in Adolescents: An Open-Label Pilot Study.

PubMed

Cullen, Kathryn R; Klimes-Dougan, Bonnie; Westlund Schreiner, Melinda; Carstedt, Patricia; Marka, Nicholas; Nelson, Katharine; Miller, Michael J; Reigstad, Kristina; Westervelt, Ana; Gunlicks-Stoessel, Meredith; Eberly, Lynn E

2018-03-01

Nonsuicidal self-injury (NSSI) is common in adolescents and young adults, and few evidence-based treatments are available for this significant problem. N-acetylcysteine (NAC) is a widely available nutritional supplement that has been studied in some psychiatric disorders relevant to NSSI including mood and addictive disorders. This pilot study tested the use of NAC as a potential treatment for NSSI in youth. Thirty-five female adolescents and young adults with NSSI aged 13-21 years were enrolled in this study that had an open-label, single-arm study design. All participants were given oral NAC as follows: 600 mg twice daily (weeks 1-2), 1200 mg twice daily (weeks 3-4), and 1800 mg twice daily (weeks 5-8). Patients were seen every 2 weeks throughout the trial, at which time youth reported the frequency of NSSI episodes. Levels of depression, impulsivity, and global psychopathology were measured at baseline and at the end of the trial using the Beck Depression Inventory-II (BDI-II), Barratt Impulsivity Scale, and Symptoms Checklist-90 (SCL-90). About two-thirds of the enrolled female youth completed the trial (24/35). NAC was generally well tolerated in this sample. NAC treatment was associated with a significant decrease in NSSI frequency at visit 6 and visit 8 compared to baseline. We also found that depression scores and global psychopathology scores (but not impulsivity scores) decreased after NAC treatment. Decrease in NSSI was not correlated with decrease in BDI-II or SCL-90 scores, suggesting these might be independent effects. We provide preliminary evidence that NAC may have promise as a potential treatment option for adolescents with NSSI. The current results require follow-up with a randomized, placebo-controlled trial to confirm efficacy.

Surgical outcomes of robot-assisted rectal cancer surgery using the da Vinci Surgical System: a multi-center pilot Phase II study.

PubMed

Tsukamoto, Shunsuke; Nishizawa, Yuji; Ochiai, Hiroki; Tsukada, Yuichiro; Sasaki, Takeshi; Shida, Dai; Ito, Masaaki; Kanemitsu, Yukihide

2017-12-01

We conducted a multi-center pilot Phase II study to examine the safety of robotic rectal cancer surgery performed using the da Vinci Surgical System during the introduction period of robotic rectal surgery at two institutes based on surgical outcomes. This study was conducted with a prospective, multi-center, single-arm, open-label design to assess the safety and feasibility of robotic surgery for rectal cancer (da Vinci Surgical System). The primary endpoint was the rate of adverse events during and after robotic surgery. The secondary endpoint was the completion rate of robotic surgery. Between April 2014 and July 2016, 50 patients were enrolled in this study. Of these, 10 (20%) had rectosigmoid cancer, 17 (34%) had upper rectal cancer, and 23 (46%) had lower rectal cancer; six underwent high anterior resection, 32 underwent low anterior resection, 11 underwent intersphincteric resection, and one underwent abdominoperineal resection. Pathological stages were Stage 0 in 1 patient, Stage I in 28 patients, Stage II in 7 patients and Stage III in 14 patients. Pathologically complete resection was achieved in all patients. There was no intraoperative organ damage or postoperative mortality. Eight (16%) patients developed complications of all grades, of which 2 (4%) were Grade 3 or higher, including anastomotic leakage (2%) and conversion to open surgery (2%). The present study demonstrates the feasibility and safety of robotic rectal cancer surgery, as reflected by low morbidity and low conversion rates, during the introduction period. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

“Pre-schoolers in the playground” an outdoor physical activity intervention for children aged 18 months to 4 years old: study protocol for a pilot cluster randomised controlled trial

PubMed Central

2013-01-01

Background The pre-school years are considered critical for establishing healthy lifestyle behaviours such as physical activity. Levels of physical activity track through childhood into adulthood, thus establishing habitual physical activity early in life is vital. Time spent outdoors is associated with greater physical activity and playground interventions have been shown to increase physical activity in school aged children. There are few pre-school, playground-based interventions, and evaluations of these have found mixed results. A recent report published by the UK Chief Medical Officer (CMO) highlighted that new interventions to promote movement in the early years (0–5 years old) are needed. The aim of this study is to undertake a pilot cluster randomised controlled trial (RCT) of an outdoor playground-based physical activity intervention for parents and their children aged 18 months to 4 years old (“Pre-schoolers in the Playground”; PiP) and to assess the feasibility of conducting a full scale cluster RCT. The PiP intervention is grounded in behavioural theory (Social Cognitive Theory), and is in accordance with the CMO guidance for physical activity in the early years. It is informed by existing literature and data collected from focus groups with parents. Methods/Design One hundred and fifty pre-school children affiliated to 10 primary schools will be recruited. Schools will be randomised to either the PiP intervention arm or the control arm (usual practice). Children in the intervention arm will be invited to attend three 30 minute outdoor play sessions per week for 30 weeks (3 school terms) at the school. Feasibility will be assessed by examining recruitment rates, attendance, attrition, acceptability of the trial and of the PiP intervention to parents, fidelity of intervention implementation, capability and capacity for schools to deliver the intervention. Health outcomes and the feasibility of outcome measurement tools will be assessed. These include physical activity via triaxial, accelerometry (Actigraph GT3X+), anthropometry (height, body mass, BMI, waist and upper arm circumference), health related quality of life for child (PedsQL) and parent (EQ5D), parent wellbeing (ComQol-A5), injuries and health service use. A health economic evaluation will also be undertaken. Discussion It is anticipated that results of this pilot trial will be published in spring 2015. Trial registration Current controlled trials: ISRCTN54165860 PMID:24107473

CDI Sensitivity and Crosstrack Error on Nonprecision Approaches

DOT National Transportation Integrated Search

1991-01-01

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

Wide single-mode tuning in quantum cascade lasers with asymmetric Mach-Zehnder interferometer type cavities with separately biased arms

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

Zheng, Mei C., E-mail: meizheng@princeton.edu; Gmachl, Claire F.; Liu, Peter Q.

2013-11-18

We report on the experimental demonstration of a widely tunable single mode quantum cascade laser with Asymmetric Mach-Zehnder (AMZ) interferometer type cavities with separately biased arms. Current and, consequently, temperature tuning of the two arms of the AMZ type cavity resulted in a single mode tuning range of 20 cm{sup −1} at 80 K in continuous-wave mode operation, a ten-fold improvement from the lasers under a single bias current. In addition, we also observed a five fold increase in the tuning rate as compared to the AMZ cavities controlled by one bias current.

A pilot randomized controlled trial to decrease adaptation difficulties in chinese new immigrants to Hong Kong.

PubMed

Yu, Xiaonan; Stewart, Sunita M; Chui, Jolian P L; Ho, Joy L Y; Li, Anthony C H; Lam, Tai Hing

2014-01-01

Immigration occurs globally, and immigrants are vulnerable to the development of adaptation difficulties. Little evidence is available for effective programs to enhance immigrant adaptation outside of the West. This pilot randomized controlled trial tested the effectiveness of two interventions used to decrease adaptation difficulties by (a) providing knowledge of resources that are relevant to the Hong Kong context or (b) enhancing personal resilience in immigrants to Hong Kong from Mainland China. A total of 220 participants were randomly assigned to three conditions: information, resilience, or control arms. They completed measures on adaptation difficulties, knowledge, and personal resilience at baseline, immediately after the intervention (postintervention), and at a 3-month follow-up. The information intervention resulted in higher increases postintervention in knowledge than did the other two arms. The resilience intervention reported greater increases in personal resilience than did the control arm at both postintervention and 3 months later; it also reported greater increases than the information arm did at the 3-month follow-up. Although both interventions reported greater decreases in adaptation difficulties than the control arm did at postintervention and 3 months later, no significant differences were found when they were compared with each other at both time points. Both programs had high acceptability and were feasible to implement in the community. Change in knowledge had no significant mediation effect on adaption difficulties, but change in personal resilience from baseline to postintervention mediated the effect of the intervention on the outcome of adaptation difficulties at the 3-month follow-up. These findings indicate evidence for benefits of the information and resilience interventions, and they inform further development of our programs. Copyright © 2013. Published by Elsevier Ltd.

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

Acupuncture for post anaesthetic recovery and postoperative pain: study protocol for a randomised controlled trial.

PubMed

Fleckenstein, Johannes; Baeumler, Petra I; Gurschler, Caroline; Weissenbacher, Tobias; Simang, Michael; Annecke, Thorsten; Geisenberger, Thomas; Irnich, Dominik

2014-07-21

We report on the design and implementation of a study protocol entitled Acupuncture randomised trial for post anaesthetic recovery and postoperative pain - a pilot study (ACUARP) designed to investigate the effectiveness of acupuncture therapy performed in the perioperative period on post anaesthetic recovery and postoperative pain. The study is designed as a randomised controlled pilot trial with three arms and partial double blinding. We will compare (a) press needle acupuncture, (b) no treatment and (c) press plaster acupressure in a standardised anaesthetic setting. Seventy-five patients scheduled for laparoscopic surgery to the uterus or ovaries will be allocated randomly to one of the three trial arms. The total observation period will begin one day before surgery and end on the second postoperative day. Twelve press needles and press plasters are to be administered preoperatively at seven acupuncture points. The primary outcome measure will be time from extubation to 'ready for discharge' from the post anaesthesia care unit (in minutes). The 'ready for discharge' end point will be assessed using three different scores: the Aldrete score, the Post Anaesthetic Discharge Scoring System and an In-House score. Secondary outcome measures will comprise pre-, intra- and postoperative variables (which are anxiety, pain, nausea and vomiting, concomitant medication). The results of this study will provide information on whether acupuncture may improve patient post anaesthetic recovery. Comparing acupuncture with acupressure will provide insight into potential therapeutic differences between invasive and non-invasive acupuncture techniques. NCT01816386 (First received: 28 October 2012).

Prospective pilot trial of PerMIT versus standard anticoagulation service management of patients initiating oral anticoagulation.

PubMed

Borgman, Mark P; Pendleton, Robert C; McMillin, Gwendolyn A; Reynolds, Kristen K; Vazquez, Sara; Freeman, Andrew; Wilson, Andrew; Valdes, Roland; Linder, Mark W

2012-09-01

We performed a randomised pilot trial of PerMIT, a novel decision support tool for genotype-based warfarin initiation and maintenance dosing, to assess its efficacy for improving warfarin management. We prospectively studied 26 subjects to compare PerMIT-guided management with routine anticoagulation service management. CYP2C9 and VKORC1 genotype results for 13 subjects randomly assigned to the PerMIT arm were recorded within 24 hours of enrolment. To aid in INR interpretation, PerMIT calculates estimated loading and maintenance doses based on a patient's genetic and clinical characteristics and displays calculated S-warfarin plasma concentrations based on planned or administered dosages. In comparison to control subjects, patients in the PerMIT study arm demonstrated a 3.6-day decrease in the time to reach a stabilised INR within the target therapeutic range (4.7 vs. 8.3 days, p = 0.015); a 12.8% increase in time spent within the therapeutic interval over the first 25 days of therapy (64.3% vs. 55.3%, p = 0.180); and a 32.9% decrease in the frequency of warfarin dose adjustments per INR measurement (38.3% vs. 57.1%, p = 0.007). Serial measurements of plasma S-warfarin concentrations were also obtained to prospectively evaluate the accuracy of the pharmacokinetic model during induction therapy. The PerMIT S-warfarin plasma concentration model estimated 62.8% of concentrations within 0.15 mg/l. These pilot data suggest that the PerMIT method and its incorporation of genotype/phenotype information may help practitioners increase the safety, efficacy, and efficiency of warfarin therapeutic management.

Gender differences in navigational memory: pilots vs. nonpilots.

PubMed

Verde, Paola; Piccardi, Laura; Bianchini, Filippo; Guariglia, Cecilia; Carrozzo, Paolo; Morgagni, Fabio; Boccia, Maddalena; Di Fiore, Giacomo; Tomao, Enrico

2015-02-01

The coding of space as near and far is not only determined by arm-reaching distance, but is also dependent on how the brain represents the extension of the body space. Recent reports suggest that the dissociation between reaching and navigational space is not limited to perception and action but also involves memory systems. It has been reported that gender differences emerged only in adverse learning conditions that required strong spatial ability. In this study we investigated navigational versus reaching memory in air force pilots and a control group without flight experience. We took into account temporal duration (working memory and long-term memory) and focused on working memory, which is considered critical in the gender differences literature. We found no gender effects or flight hour effects in pilots but observed gender effects in working memory (but not in learning and delayed recall) in the nonpilot population (Women's mean = 5.33; SD= 0.90; Men's mean = 5.54; SD= 0.90). We also observed a difference between pilots and nonpilots in the maintenance of on-line reaching information: pilots (mean = 5.85; SD=0.76) were more efficient than nonpilots (mean = 5.21; SD=0.83) and managed this type of information similarly to that concerning navigational space. In the navigational learning phase they also showed better navigational memory (mean = 137.83; SD=5.81) than nonpilots (mean = 126.96; SD=15.81) and were significantly more proficient than the latter group. There is no gender difference in a population of pilots in terms of navigational abilities, while it emerges in a control group without flight experience. We found also that pilots performed better than nonpilots. This study suggests that once selected, male and female pilots do not differ from each other in visuo-spatial abilities and spatial navigation.

Winged Auxiliaries: Women Pilots in the UK and US during World War Two

NASA Astrophysics Data System (ADS)

Schrader, Helena P.

2006-05-01

During World War II women in the US and the UK were given the then unprecedented opportunity to fly military aircraft. Yet while the women flying in the UK soon gained the privileges and status enjoyed by their male colleagues, the American women pilots were expressly denied the same status, rank, pay, and benefits as USAAF pilots. In fact, after an ugly slander campaign against the women pilots' organisation, the US programme was discontinued and the women were sent home before their job was done. The American women pilots were not less dedicated or inherently less capable than the women flying in Britain. Rather, key environmental and organisational differences and above all a failure of leadership accounts for their fate. This paper summarises the differences and their impact. The complete findings of the comparative research on the experiences of women pilots in the US and the UK during WWII will be published by Pen & Sword Books Inc early in 2006 under the title Sisters in Arms.

Arm cranking versus wheelchair propulsion for testing aerobic fitness in children with spina bifida who are wheelchair dependent.

PubMed

Bloemen, Manon A T; de Groot, Janke F; Backx, Frank J G; Westerveld, Rosalyne A; Takken, Tim

2015-05-01

To determine the best test performance and feasibility using a Graded Arm Cranking Test vs a Graded Wheelchair Propulsion Test in young people with spina bifida who use a wheelchair, and to determine the reliability of the best test. Validity and reliability study. Young people with spina bifida who use a wheelchair. Physiological responses were measured during a Graded Arm Cranking Test and a Graded Wheelchair Propulsion Test using a heart rate monitor and calibrated mobile gas analysis system (Cortex Metamax). For validity, peak oxygen uptake (VO2peak) and peak heart rate (HRpeak) were compared using paired t-tests. For reliability, the intra-class correlation coefficients, standard error of measurement, and standard detectable change were calculated. VO2peak and HRpeak were higher during wheelchair propulsion compared with arm cranking (23.1 vs 19.5 ml/kg/min, p = 0.11; 165 vs 150 beats/min, p < 0.05). Reliability of wheelchair propulsion showed high intra-class correlation coefficients (ICCs) for both VO2peak (ICC = 0.93) and HRpeak (ICC = 0.90). This pilot study shows higher HRpeak and a tendency to higher VO2peak in young people with spina bifida who are using a wheelchair when tested during wheelchair propulsion compared with arm cranking. Wheelchair propulsion showed good reliability. We recommend performing a wheelchair propulsion test for aerobic fitness testing in this population.

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

PubMed Central

2017-01-01

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

The influence of polymer architecture on the assembly of poly(ethylene oxide) grafted C60 fullerene clusters in aqueous solution: a molecular dynamics simulation study.

PubMed

Hooper, Justin B; Bedrov, Dmitry; Smith, Grant D

2009-03-28

The effect of polymer architecture on the aggregation behavior of C60 fullerenes tethered with a single chain of poly(ethylene oxide) (PEO) in aqueous solution has been investigated using coarse-grained, implicit solvent molecular dynamics simulations. The PEO-grafted fullerenes were comprised of a single tether of 60 repeat units represented as a linear polymer, a three-arm star (20 repeat units/arm) or a six-arm star (10 repeat units/arm). Additionally, the influence of arm length on self-assembly of the PEO-fullerene conjugates was investigated for the three-arm stars. Self-assembly is driven by favorable fullerene-fullerene and fullerene-PEO interactions. Our simulations reveal that it should be possible to control the size and geometry of the self-assembled fullerene aggregates in water through variation of PEO architecture and PEO molecular weight. We found that aggregate size and shape could be understood qualitatively in terms of the packing parameter concept that has been employed for diblock polymer and surfactant self-assembly. Higher molecular weight PEO (longer arms) and more compact PEO (more arms for the same molecular weight) resulted in greater steric repulsion between fullerenes, engendering greater aggregate surface curvature and hence the formation of smaller, more spherically shaped aggregates. Finally, weak attractive interactions between PEO and the fullerenes were found to play an important role in determining aggregate shape, size and the dynamics of self-assembly.

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

NASA Astrophysics Data System (ADS)

Mandal, Tanmay Kumar

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

Mechanisms of Injury and Countermeasures for EVA Associated Upper Extremity Medical Issues: Extended Vent Tube Study

NASA Technical Reports Server (NTRS)

Jones, Jeff; Hoffman, Ron; Harvey, Craig; Bowen, C. K.; Hudy, C. E.; Tuxhorn, Jennifer; Gernhardt, Mike; Scheuring, Richard A.

2007-01-01

The goal of this study is to determine the role that moisture plays in the injury to the fingers and fingernails during EVA training operations in the Neutral Buoyancy Laboratory. Current Extravehicular Mobility Unit (EMU, with a PLSS) as configured in the NBL was used for all testing and a vent tube was extended down a single arm of the crewmember during the test; vent tube was moved between left and right arm to serve as experimental condition being investigated and the other arm served as control condition.

Single-Pilot Workload Management

NASA Technical Reports Server (NTRS)

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

2013-01-01

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

STS-95 Day 07 Highlights

NASA Technical Reports Server (NTRS)

1998-01-01

On this seventh day of the STS-95 mission, the flight crew, Cmdr. Curtis L. Brown, Pilot Steven W. Lindsey, Mission Specialists Scott E. Parazynski, Stephen K. Robinson, and Pedro Duque, and Payload Specialists Chiaki Mukai and John H. Glenn, again test the Orbiter Space Vision System. OSVS uses special markings on Spartan and the shuttle cargo bay to provide an alignment aid for the arm's operator using shuttle television images. It will be used extensively on the next Space Shuttle flight in December as an aid in using the arm to join together the first two modules of the International Space Station. Specialist John Glenn will complete a daily back-pain questionnaire by as part of a study of how the muscle, intervertebral discs and bone marrow change after exposure to microgravity.

Oral language supports early literacy: a pilot cluster randomized trial in disadvantaged schools.

PubMed

Snow, Pamela C; Eadie, Patricia A; Connell, Judy; Dalheim, Brenda; McCusker, Hugh J; Munro, John K

2014-10-01

This study examined the impact of teacher professional development aimed at improving the capacity of primary teachers in disadvantaged schools to strengthen children's expressive and receptive oral language skills and early literacy success in the first 2 years of school. Fourteen low-SES schools in Victoria, Australia were randomly allocated to a research (n = 8) or control arm (n = 6), resulting in an initial sample of 1254 students, (n = 602 in research arm and n = 652 in control arm). The intervention comprised 6 days of teacher and principal professional development (delivered by language and literacy experts), school-based continuing contact with the research team and completion by one staff member of each research school of a postgraduate unit on early language and literacy. Schools in the control arm received standard teaching according to state auspiced curriculum guidelines. Full data were available on 979 students at follow-up (time 2). Students in the research arm performed significantly better on Test of Language Development: Primary (Fourth Edition) sub-tests (p ≤ .002) and the Reading Progress Test (F = 10.4(1); p = .001) than students in the control arm at time 2. Narrative scores were not significantly different at time 2, although students in research schools showed greater gains. Findings provide "proof of concept" for this approach, and are discussed with respect to implications for teacher professional development and pre-service education concerning the psycholinguistic competencies that underpin the transition to literacy.

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

ERIC Educational Resources Information Center

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

2015-01-01

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

Results of a pilot randomised controlled trial to measure the clinical and cost effectiveness of peer support in increasing hope and quality of life in mental health patients discharged from hospital in the UK

PubMed Central

2014-01-01

Background Mental health patients can feel anxious about losing the support of staff and patients when discharged from hospital and often discontinue treatment, experience relapse and readmission to hospital, and sometimes attempt suicide. The benefits of peer support in mental health services have been identified in a number of studies with some suggesting clinical and economic gains in patients being discharged. Methods This pilot randomised controlled trial with economic evaluation aimed to explore whether peer support in addition to usual aftercare for patients during the transition from hospital to home would increase hope, reduce loneliness, improve quality of life and show cost effectiveness compared with patients receiving usual aftercare only, with follow-up at one and three-months post-discharge. Results A total of 46 service users were recruited to the study; 23 receiving peer support and 23 in the care-as-usual arm. While this pilot trial found no statistically significant benefits for peer support on the primary or secondary outcome measures, there is an indication that hope may be further increased in those in receipt of peer support. The total cost per case for the peer support arm of the study was £2154 compared to £1922 for the control arm. The mean difference between costs was minimal and not statistically significant. However, further analyses demonstrated that peer support has a reasonably high probability of being more cost effective for a modest positive change in the measure of hopelessness. Challenges faced in recruitment and follow-up are explored alongside limitations in the delivery of peer support. Conclusions The findings suggest there is merit in conducting further research on peer support in the transition from hospital to home consideration should be applied to the nature of the patient population to whom support is offered; the length and frequency of support provided; and the contact between peer supporters and mental health staff. There is no conclusive evidence to support the cost effectiveness of providing peer support, but neither was it proven a costly intervention to deliver. The findings support an argument for a larger scale trial of peer support as an adjunct to existing services. Trial registration Current Controlled Trials ISRCTN74852771 PMID:24495599

Results of a pilot randomised controlled trial to measure the clinical and cost effectiveness of peer support in increasing hope and quality of life in mental health patients discharged from hospital in the UK.

PubMed

Simpson, Alan; Flood, Chris; Rowe, Julie; Quigley, Jody; Henry, Susan; Hall, Cerdic; Evans, Richard; Sherman, Paul; Bowers, Len

2014-02-05

Mental health patients can feel anxious about losing the support of staff and patients when discharged from hospital and often discontinue treatment, experience relapse and readmission to hospital, and sometimes attempt suicide. The benefits of peer support in mental health services have been identified in a number of studies with some suggesting clinical and economic gains in patients being discharged. This pilot randomised controlled trial with economic evaluation aimed to explore whether peer support in addition to usual aftercare for patients during the transition from hospital to home would increase hope, reduce loneliness, improve quality of life and show cost effectiveness compared with patients receiving usual aftercare only, with follow-up at one and three-months post-discharge. A total of 46 service users were recruited to the study; 23 receiving peer support and 23 in the care-as-usual arm. While this pilot trial found no statistically significant benefits for peer support on the primary or secondary outcome measures, there is an indication that hope may be further increased in those in receipt of peer support. The total cost per case for the peer support arm of the study was £2154 compared to £1922 for the control arm. The mean difference between costs was minimal and not statistically significant. However, further analyses demonstrated that peer support has a reasonably high probability of being more cost effective for a modest positive change in the measure of hopelessness. Challenges faced in recruitment and follow-up are explored alongside limitations in the delivery of peer support. The findings suggest there is merit in conducting further research on peer support in the transition from hospital to home consideration should be applied to the nature of the patient population to whom support is offered; the length and frequency of support provided; and the contact between peer supporters and mental health staff. There is no conclusive evidence to support the cost effectiveness of providing peer support, but neither was it proven a costly intervention to deliver. The findings support an argument for a larger scale trial of peer support as an adjunct to existing services. Current Controlled Trials ISRCTN74852771.

Randomised controlled trial comparing hypnotherapy versus gabapentin for the treatment of hot flashes in breast cancer survivors: a pilot study

PubMed Central

MacLaughlan David, Shannon; Salzillo, Sandra; Bowe, Patrick; Scuncio, Sandra; Malit, Bridget; Raker, Christina; Gass, Jennifer S; Granai, C O; Dizon, Don S

2013-01-01

Objectives To compare the efficacy of hypnotherapy versus gabapentin for the treatment of hot flashes in breast cancer survivors, and to evaluate the feasibility of conducting a clinical trial comparing a drug with a complementary or alternative method (CAM). Design Prospective randomised trial. Setting Breast health centre of a tertiary care centre. Participants 15 women with a personal history of breast cancer or an increased risk of breast cancer who reported at least one daily hot flash. Interventions Gabapentin 900 mg daily in three divided doses (control) compared with standardised hypnotherapy. Participation lasted 8 weeks. Outcome measures The primary endpoints were the number of daily hot flashes and hot flash severity score (HFSS). The secondary endpoint was the Hot Flash Related Daily Interference Scale (HFRDIS). Results 27 women were randomised and 15 (56%) were considered evaluable for the primary endpoint (n=8 gabapentin, n=7 hypnotherapy). The median number of daily hot flashes at enrolment was 4.5 in the gabapentin arm and 5 in the hypnotherapy arm. HFSS scores were 7.5 in the gabapentin arm and 10 in the hypnotherapy arm. After 8 weeks, the median number of daily hot flashes was reduced by 33.3% in the gabapentin arm and by 80% in the hypnotherapy arm. The median HFSS was reduced by 33.3% in the gabapentin arm and by 85% in the hypnotherapy arm. HFRDIS scores improved by 51.6% in the gabapentin group and by 55.2% in the hypnotherapy group. There were no statistically significant differences between groups. Conclusions Hypnotherapy and gabapentin demonstrate efficacy in improving hot flashes. A definitive trial evaluating traditional interventions against CAM methods is feasible, but not without challenges. Further studies aimed at defining evidence-based recommendations for CAM are necessary. Trial registration clinicaltrials.gov (NCT00711529). PMID:24022390

Simultaneous Genotyping of the rs4762 and rs699 Polymorphisms in Angiotensinogen Gene and Correlation with Iranian CAD Patients with Novel Hexa-primer ARMS-PCR

PubMed Central

KHATAMI, Mehri; HEIDARI, Mohammad Mehdi; HADADZADEH, Mehdi; SCHEIBER-MOJDEHKAR, Barbara; BITARAF SANI, Morteza; HOUSHMAND, Massoud

2017-01-01

Background: A significant role of Renin-angiotensin system (RAS) genetic variants in the pathogenesis of essential hypertension and cardiovascular diseases has been proved. This study aimed to develop a new, fast and cheap method for the simultaneous detection of two missense single nucleotide polymorphisms (T207M or rs4762 and M268T orrs699) of angiotensinogen (AGT) in single-step Multiplex Hexa-Primer Amplification Refractory Mutation System - polymerase chain reaction (H-ARMS-PCR). Methods: In this case-control study, 148 patients with coronary artery disease (CAD) and 135 controls were included. The patients were referred to cardiac centers in Afshar Hospital (Yazd, Iran) from 2012 to 2015. Two sets of inner primer (for each SNP) and one set outer primer pairs were designed for genotyping of rs4762 and rs699 in single tube H-ARMS-PCR. Direct sequencing of all samples was also performed to assess the accuracy of this method. DNA sequencing method validated the results of single tube H-ARMS-PCR. Results: We found full accordance for genotype adscription by sequencing method. The frequency of the AGT T521 and C702 alleles was significantly higher in CAD patients than in the control group (OR: 0.551, 95% CI: 0.359–0.846, P=0.008 and OR: 0.629, 95% CI: 0.422–0.936, P=0.028, respectively). Conclusion: This is the first work describing a rapid, low-cost, high-throughput simultaneous detection of rs4762 and rs699 polymorphisms in AGT gene, used in large clinical studies. PMID:28828324

Uptake of community-based, self-collected HPV testing vs. visual inspection with acetic acid for cervical cancer screening in Kampala, Uganda: preliminary results of a randomised controlled trial.

PubMed

Moses, Erin; Pedersen, Heather N; Mitchell, Sheona M; Sekikubo, Musa; Mwesigwa, David; Singer, Joel; Biryabarema, Christine; Byamugisha, Josaphat K; Money, Deborah M; Ogilvie, Gina S

2015-10-01

To compare two cervical cancer screening methods: community-based self-collection of high-risk human papillomavirus (HR-HPV) testing and visual inspection with acetic acid (VIA). Pilot randomised controlled trial of 500 women aged 30-65 in the community of Kisenyi, Uganda. Women randomised to self-collection-based HR-HPV testing provided a cervico-vaginal swab for HR-HPV, and results were provided by phone after laboratory testing. Women who tested HPV positive were referred for VIA at the local health unit. Women randomised to VIA underwent screening at the local health unit, where women who tested positive with VIA were provided cryotherapy at time of screening, as per local standard of care. Women were referred for colposcopy when indicated. Outcome measures were uptake of screening, HR-HPV prevalence, VIA result and treatment rates. In the HR-HPV arm, 248 of 250 (p < 0.01) women provided samples, while in the VIA arm, 121 of 250 (48.4%) women attended screening. Among the 73 of 248 HR-HPV-positive women, 45.2% (N = 33) attended VIA screening for follow-up, 21.2% (N = 7) of whom screened positive; five received treatment and two were missing clinical follow-up records. Of the 121 women in the VIA arm who attended screening, 13.2% (N = 16) screened positive; seven received cryotherapy, three refused treatment, five were referred to colposcopy; and one woman had suspected cervical cancer and received treatment after confirmatory testing. This pilot study demonstrated trial feasibility and willingness of the women to participate and be randomised successfully into the two arms. Self-collection-based cervical cancer screening had a higher uptake than VIA. © 2015 John Wiley & Sons Ltd.

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

NASA Technical Reports Server (NTRS)

Hinton, David A.; Lohr, Gary W.

1988-01-01

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

32 CFR 47.3 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... use of military and civilian forces. (a) Examples of armed conflict are World Wars I and II, and the... Forces Service Pilots of World War II. ... 32 National Defense 1 2013-07-01 2013-07-01 false Definitions. 47.3 Section 47.3 National Defense...

32 CFR 47.3 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... use of military and civilian forces. (a) Examples of armed conflict are World Wars I and II, and the... Forces Service Pilots of World War II. ... 32 National Defense 1 2012-07-01 2012-07-01 false Definitions. 47.3 Section 47.3 National Defense...

32 CFR 47.3 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... use of military and civilian forces. (a) Examples of armed conflict are World Wars I and II, and the... Forces Service Pilots of World War II. ... 32 National Defense 1 2014-07-01 2014-07-01 false Definitions. 47.3 Section 47.3 National Defense...

STS-87 Day 03 Highlights

NASA Technical Reports Server (NTRS)

1997-01-01

On this third day of the STS-87 mission, the flight crew, Cmdr. Kevin R. Kregel, Pilot Steven W. Lindsey, Mission Specialists Winston E. Scott, Kalpana Chawla, and Takao Doi, and Payload Specialist Leonid K. Kadenyuk deploy the Spartan satellite with the shuttle's robot arm.

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

NASA Technical Reports Server (NTRS)

Chapman, G. C.

1983-01-01

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

Cognitive Analytic Therapy for Bipolar Disorder: A Pilot Randomized Controlled Trial.

PubMed

Evans, Mark; Kellett, Stephen; Heyland, Simon; Hall, Jo; Majid, Shazmin

2017-01-01

The evidence base for treatment of bipolar affective disorder (BD) demands the evaluation of new psychotherapies in order to broaden patient choice. This study reports on the feasibility, safety, helpfulness and effectiveness of cognitive analytic therapy (CAT). In a pilot randomized controlled trial, BD patients in remission were randomized to either receiving 24 sessions of CAT (n = 9) or treatment as usual (n = 9) and were assessed in terms of symptoms, functioning and service usage over time. In the CAT arm no adverse events occurred, 8/9 completed treatment, 5/8 attended all 24 sessions and 2/8 were categorized as recovered. The most common helpful event during CAT was recognition of patterns in mood variability, with helpfulness themes changing according to phase of therapy. No major differences were found when comparing the arms over time in terms of service usage or psychometric outcomes. The study suggests that conducting further research into the effectiveness of CAT in treating BD is warranted and guidance regarding future trials is provided. Copyright © 2016 John Wiley & Sons, Ltd. Treating BD with CAT appears feasible and safe. Retaining fidelity to the reformulation, recognition and revision structure of CAT appears useful. Participants stated that across the phases of CAT, focussing on patterns of mood variability was consistently helpful. Copyright © 2016 John Wiley & Sons, Ltd.

Three input concepts for flight crew interaction with information presented on a large-screen electronic cockpit display

NASA Technical Reports Server (NTRS)

Jones, Denise R.

1990-01-01

A piloted simulation study was conducted comparing three different input methods for interfacing to a large-screen, multiwindow, whole-flight-deck display for management of transport aircraft systems. The thumball concept utilized a miniature trackball embedded in a conventional side-arm controller. The touch screen concept provided data entry through a capacitive touch screen. The voice concept utilized a speech recognition system with input through a head-worn microphone. No single input concept emerged as the most desirable method of interacting with the display. Subjective results, however, indicate that the voice concept was the most preferred method of data entry and had the most potential for future applications. The objective results indicate that, overall, the touch screen concept was the most effective input method. There was also significant differences between the time required to perform specific tasks and the input concept employed, with each concept providing better performance relative to a specific task. These results suggest that a system combining all three input concepts might provide the most effective method of interaction.

Longitudinal wearable tremor measurement system with activity recognition algorithms for upper limb tremor.

PubMed

Jeonghee Kim; Parnell, Claire; Wichmann, Thomas; DeWeerth, Stephen P

2016-08-01

Assessments of tremor characteristics by movement disorder physicians are usually done at single time points in clinic settings, so that the description of the tremor does not take into account the dependence of the tremor on specific behavioral situations. Moreover, treatment-induced changes in tremor or behavior cannot be quantitatively tracked for extended periods of time. We developed a wearable tremor measurement system with tremor and activity recognition algorithms for long-term upper limb behavior tracking, to characterize tremor characteristics and treatment effects in their daily lives. In this pilot study, we collected sensor data of arm movement from three healthy participants using a wrist device that included a 3-axis accelerometer and a 3-axis gyroscope, and classified tremor and activities within scenario tasks which resembled real life situations. Our results show that the system was able to classify the tremor and activities with 89.71% and 74.48% accuracies during the scenario tasks. From this results, we expect to expand our tremor and activity measurement in longer time period.

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

NASA Technical Reports Server (NTRS)

Adams, J. J.

1976-01-01

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

Stratocumulus Precipitation and Entrainment Experiment (SPEE) Field Campaign Report

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

Albrecht, Bruce; Ghate, Virendra; CADeddu, Maria

2016-06-01

The scientific focus of this project was to examine precipitation and entrainment processes in marine stratocumulus clouds. The entrainment studies focused on characterizing cloud turbulence at cloud top using Doppler cloud radar observations. The precipitation studies focused on characterizing the precipitation and the macroscopic properties (cloud thickness, and liquid water path) of the clouds. This project will contribute to the U.S. Department of Energy (DOE) Atmospheric Radiation Measurement (ARM) Climate Research Facility’s overall objective of providing the remote-sensing observations needed to improve the representation of key cloud processes in climate models. It will be of direct relevance to the componentsmore » of ARM dealing with entrainment and precipitation processes in stratiform clouds. Further, the radar observing techniques that will be used in this study were developed using ARM Southern Great Plains (SGP) facility observations under Atmospheric System Research (ASR) support. The observing systems operating automatously from a site located just north of the Center for Interdisciplinary Remotely-Piloted Aircraft Studies (CIRPAS) aircraft hangar in Marina, California during the period of 1 May to 4 November 2015 included: 1. Microwave radiometer: ARM Microwave Radiometer, 3-Channel (MWR3C) with channels centered at 23.834, 30, and 89 GHz; supported by Dr. Maria Cadeddu. 2. Cloud Radar: CIRPAS 95 GHz Frequency Modulated Continuous Wave (FMCW) Cloud Radar (Centroid Frequency Chirp Rate [CFCR]); operations overseen by Drs. Ghate and Albrecht. 3. Ceilometer: Vaisala CK-14; operations overseen by Drs. Ghate and Albrecht.« less

A randomized open-label study of guideline-driven antiemetic therapy versus single agent antiemetic therapy in patients with advanced cancer and nausea not related to anticancer treatment.

PubMed

Hardy, Janet; Skerman, Helen; Glare, Paul; Philip, Jennifer; Hudson, Peter; Mitchell, Geoffrey; Martin, Peter; Spruyt, Odette; Currow, David; Yates, Patsy

2018-05-02

Nausea/vomiting (N/V) not related to anti-cancer treatment is common in patients with advanced cancer. The standard approach to management is to define a dominant cause, and treat with an antiemetic selected through pathophysiologic knowledge of emetic pathways. High rates of N/V control have been reported using both etiology-based guideline-driven antiemetic regimens and an empiric approach using single agents in uncontrolled studies. These different approaches had never been formally compared. This randomized, prospective, open label, dose-escalating study used readily available antiemetics in accordance with etiology-based guidelines or single agent therapy with haloperidol. Participants had a baseline average nausea score of ≥3/10. Response was defined as a ≥ 2/10 point reduction on a numerical rating scale of average nausea score with a final score < 3/10 at 72 h. Nausea scores and distress from nausea improved over time in the majority of the 185 patients randomized. For those who completed each treatment day, a greater response rate was seen in the guideline arm than the single agent arm at 24 h (49% vs 32%; p = 0.02), but not at 48 or 72 h. Response rates at 72 h in the intention to treat analysis were 49 and 53% respectively, with no significant difference between arms (0·04; 95% CI: -0·11, 0·19; p = 0·59). Over 80% of all participants reported an improved global impression of change. There were few adverse events worse than baseline in either arm. An etiology-based, guideline-directed approach to antiemetic therapy may offer more rapid benefit, but is no better than single agent treatment with haloperidol at 72 h. Australian New Zealand Clinical Trials Registry: ANZCTRN12610000481077 .

Central implementation strategies outperform local ones in improving HIV testing in Veterans Healthcare Administration facilities.

PubMed

Goetz, Matthew Bidwell; Hoang, Tuyen; Knapp, Herschel; Burgess, Jane; Fletcher, Michael D; Gifford, Allen L; Asch, Steven M

2013-10-01

Pilot data suggest that a multifaceted approach may increase HIV testing rates, but the scalability of this approach and the level of support needed for successful implementation remain unknown. To evaluate the effectiveness of a scaled-up multi-component intervention in increasing the rate of risk-based and routine HIV diagnostic testing in primary care clinics and the impact of differing levels of program support. Three arm, quasi-experimental implementation research study. Veterans Health Administration (VHA) facilities. Persons receiving primary care between June 2009 and September 2011 INTERVENTION: A multimodal program, including a real-time electronic clinical reminder to facilitate HIV testing, provider feedback reports and provider education, was implemented in Central and Local Arm Sites; sites in the Central Arm also received ongoing programmatic support. Control Arm sites had no intervention Frequency of performing HIV testing during the 6 months before and after implementation of a risk-based clinical reminder (phase I) or routine clinical reminder (phase II). The adjusted rate of risk-based testing increased by 0.4 %, 5.6 % and 10.1 % in the Control, Local and Central Arms, respectively (all comparisons, p < 0.01). During phase II, the adjusted rate of routine testing increased by 1.1 %, 6.3 % and 9.2 % in the Control, Local and Central Arms, respectively (all comparisons, p < 0.01). At study end, 70-80 % of patients had been offered an HIV test. Use of clinical reminders, provider feedback, education and social marketing significantly increased the frequency at which HIV testing is offered and performed in VHA facilities. These findings support a multimodal approach toward achieving the goal of having every American know their HIV status as a matter of routine clinical practice.

Use of a GnRH antagonist in controlled ovarian hyperstimulation for assisted conception in women with polycystic ovary disease: a randomized, prospective, pilot study.

PubMed

Bahçeci, Mustafa; Ulug, Ulun; Ben-Shlomo, Izhar; Erden, Halit Firat; Akman, Mehmet Ali

2005-02-01

To compare the outcome of using gonadotropin-releasing hormone (GnRH) antagonists versus agonists in women with polycystic ovary disease (PCOD) who underwent controlled ovarian hyperstimulation (COH) for assisted reproductive techniques (ART). A total of 129 patients with PCOD were randomly allocated to undergo COH with a GnRH antagonist (59 patients) and GnRH agonist (leuprolide acetate) (70 patients) to prevent a premature luteinizing hormone (LH) surge. Assisted fertilization following oocyte retrieval and embryo transfer was performed. None of the cycles were cancelled due to a premature LH surge. There was no significant difference between the antagonist and agonist arms in the number of gonadotropin ampules consumed per cycle. However, in the antagonist arm a shorter duration of ovarian stimulation was recorded as compared to the agonist arm. Although similar numbers of oocytes was retrieved from both groups of patients, the quality of the oocytes, as measured by metaphase 2/total oocyte ratio, was lower in the antagonist arm as compared to the agonist arm. Pregnancy rates were 57.6% and 58.5% in the antagonist and agonist arms, respectively (p > 0.05). Implantation rates were not different (34.0% and 34.6%, respectively). The frequency of ovarian hyperstimulation syndrome also did not differ between the treatment groups (5% and 7.1%, respectively). The size of our study, on a specific subgroup of patients, does not allow a reliable conclusion regarding ART outcomefollowing the use of a GnRH antagonist versus agonist. Nevertheless, the protocol with the antagonist gave results that were as good as those of the protocol with the agonist in this PCOD patient population.

Telerobotic control of a dextrous manipulator using master and six-DOF hand-controllers for space assembly and servicing tasks

NASA Technical Reports Server (NTRS)

O'Hara, John M.

1987-01-01

Two studies were conducted evaluating methods of controlling a telerobot; bilateral force reflecting master controllers and proportional rate six degrees of freedom (DOF) hand controllers. The first study compared the controllers on performance of single manipulator arm tasks, a peg-in-the-hole task, and simulated satellite orbital replacement unit changeout. The second study, a Space Station truss assembly task, required simultaneous operation of both manipulator arms (all 12 DOFs) and complex multiaxis slave arm movements. Task times were significantly longer and fewer errors were committed with the hand controllers. The hand controllers were also rated significantly higher in cognitive and manual control workload on the two-arm task. The master controllers were rated significantly higher in physical workload. There were no significant differences in ratings of manipulator control quality.

Effectiveness of Virtual Reality Using Wii Gaming Technology in Stroke Rehabilitation

PubMed Central

Saposnik, Gustavo; Teasell, Robert; Mamdani, Muhammad; Hall, Judith; McIlroy, William; Cheung, Donna; Thorpe, Kevin E.; Cohen, Leonardo G.; Bayley, Mark

2016-01-01

Background and Purpose Hemiparesis resulting in functional limitation of an upper extremity is common among stroke survivors. Although existing evidence suggests that increasing intensity of stroke rehabilitation therapy results in better motor recovery, limited evidence is available on the efficacy of virtual reality for stroke rehabilitation. Methods In this pilot, randomized, single-blinded clinical trial with 2 parallel groups involving stroke patients within 2 months, we compared the feasibility, safety, and efficacy of virtual reality using the Nintendo Wii gaming system (VRWii) versus recreational therapy (playing cards, bingo, or “Jenga”) among those receiving standard rehabilitation to evaluate arm motor improvement. The primary feasibility outcome was the total time receiving the intervention. The primary safety outcome was the proportion of patients experiencing intervention-related adverse events during the study period. Efficacy, a secondary outcome measure, was evaluated with the Wolf Motor Function Test, Box and Block Test, and Stroke Impact Scale at 4 weeks after intervention. Results Overall, 22 of 110 (20%) of screened patients were randomized. The mean age (range) was 61.3 (41 to 83) years. Two participants dropped out after a training session. The interventions were successfully delivered in 9 of 10 participants in the VRWii and 8 of 10 in the recreational therapy arm. The mean total session time was 388 minutes in the recreational therapy group compared with 364 minutes in the VRWii group (P=0.75). There were no serious adverse events in any group. Relative to the recreational therapy group, participants in the VRWii arm had a significant improvement in mean motor function of 7 seconds (Wolf Motor Function Test, 7.4 seconds; 95% CI, −14.5, −0.2) after adjustment for age, baseline functional status (Wolf Motor Function Test), and stroke severity. Conclusions VRWii gaming technology represents a safe, feasible, and potentially effective alternative to facilitate rehabilitation therapy and promote motor recovery after stroke. PMID:20508185

A Study of Longitudinal Control Problems at Low and Negative Damping and Stability with Emphasis on Effects of Motion Cues

NASA Technical Reports Server (NTRS)

Sadoff, Melvin; McFadden, Norman M.; Heinle, Donovan R.

1961-01-01

As part of a general investigation to determine the effects of simulator motions on pilot opinion and task performance over a wide range of vehicle longitudinal dynamics, a cooperative NASA-AMAL program was conducted on the centrifuge at Johnsville, Pennsylvania. The test parameters and measurements for this program duplicated those of earlier studies made at Ames Research Center with a variable-stability airplane and with a pitch-roll chair flight simulator. Particular emphasis was placed on the minimum basic damping and stability the pilots would accept and on the minimum dynamics they considered controllable in the event of stability-augmentation system failure. Results of the centrifuge-simulator program indicated that small positive damping was required by the pilots over most of the frequency range covered for configurations rated acceptable for emergency conditions only (e.g., failure of a pitch damper). It was shown that the pilot's tolerance for unstable dynamics was dependent primarily on the value of damping. For configurations rated acceptable for emergency operation only, the allowable instability and damping corresponded to a divergence time to double amplitude of about 1 second. Comparisons were made of centrifuge, pitch-chair and fixed-cockpit simulator tests with flight tests. Pilot ratings indicated that the effects of incomplete or spurious motion cues provided by these three modes of simulation were important only for high-frequency, lightly damped dynamics or unstable, moderately damped dynamics. The pitch- chair simulation, which provided accurate angular-acceleration cues to the pilot, compared most favorably with flight. For the centrifuge simulation, which furnished accurate normal accelerations but spurious pitching and longitudinal accelerations, there was a deterioration of pilots' opinion relative to flight results. Results of simulator studies with an analog pilot replacing the human pilot illustrated the adaptive capability of human pilots in coping with the wide range of vehicle dynamics and the control problems covered in this study. It was shown that pilot-response characteristics, deduced by the analog-pilot method, could be related to pilot opinion. Possible application of these results for predicting flight-control problems was illustrated by means of an example control-problem analysis. The results of a brief evaluation of a pencil-type side-arm controller in the centrifuge showed a considerable improvement in the pilots' ability to cope with high-frequency, low-damping dynamics, compared to results obtained with the center stick. This improvement with the pencil controller was attributed primarily to a marked reduction in the adverse effects of large and exaggerated pitching and longitudinal accelerations on pilot control precision.

STS-114: Discovery TCDT Flight Crew Test Media Event at Pad 39-B

NASA Technical Reports Server (NTRS)

2005-01-01

The STS-114 Space Shuttle Discovery Terminal Countdown Demonstration Test (TCDT) flight crew is shown at Pad 39-B. Eileen Collins, Commander introduces the astronauts. Andrew Thomas, mission specialist talks about his primary responsibility of performing boom inspections, Wendy Lawrence, Mission Specialist 4 (MS4) describes her role as the robotic arm operator supporting Extravehicular Activities (EVA), Stephen Robinson, Mission Specialist 3 (MS3) talks about his role as flight engineer, Charlie Camarda, Mission Specialist 5 (MS5) says that his duties are to perform boom operations, transfer operations from the space shuttle to the International Space Station and spacecraft rendezvous. Soichi Noguchi, Mission Specialist 1 (MS1) from JAXA, introduces himself as Extravehicular Activity 1 (EVA1), and Jim Kelley, Pilot will operate the robotic arm and perform pilot duties. Questions from the news media about the safety of the external tank, going to the International Space Station and returning, EVA training, and thoughts about the Space Shuttle Columbia crew are answered.

STS-92 Pilot Melroy gets suit checked in the White Room before launch

NASA Technical Reports Server (NTRS)

2000-01-01

STS-92 Pilot Pamela Ann Melroy has a final check on her launch and entry suit in the White Room before entering Discovery. The White Room is an environmentally controlled area at the end of the Orbiter Access Arm that provides entry to the orbiter as well as emergency egress if needed. The arm remains in the extended position until 7 minutes 24 seconds before launch. Melroy and the rest of the crew are undertaking the fifth flight to the International Space Station for construction. Discovery carries a payload that includes the Integrated Truss Structure Z-1, first of 10 trusses that will form the backbone of the Space Station, and the third Pressurized Mating Adapter that will provide a Shuttle docking port for solar array installation on the sixth Station flight and Lab installation on the seventh Station flight. The mission includes four spacewalks for the construction activities. Discovery's landing is expected Oct. 22 at 2:10 p.m. EDT.

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

ERIC Educational Resources Information Center

Taylor, Mark J.

2018-01-01

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

Mirror therapy in children with hemiplegia: a pilot study.

PubMed

Gygax, Marine Jequier; Schneider, Patrick; Newman, Christopher John

2011-05-01

Mirror therapy, which provides the visual illusion of a functional paretic limb by using the mirror reflection of the non-paretic arm, is used in the rehabilitation of hemiparesis after stroke in adults. We tested the effectiveness and feasibility of mirror therapy in children with hemiplegia by performing a pilot crossover study in ten participants (aged 6-14 y; five males, five females; Manual Ability Classification System levels: one at level I, two at level II, four at level III, three at level IV) randomly assigned to 15 minutes of daily bimanual training with and without a mirror for 3 weeks. Assessments of maximal grasp and pinch strengths, and upper limb function measured by the Shriner's Hospital Upper Extremity Evaluation were performed at weeks 0 (baseline), 3, 6 (intervention), and 9 (wash-out). Testing of grasp strength behind the mirror improved performance by 15% (p=0.004). Training with the mirror significantly improved grasp strength (with mirror +20.4%, p=0.033; without +5.9%, p>0.1) and upper limb dynamic position (with mirror +4.6%, p=0.044; without +1.2%, p>0.1), while training without a mirror significantly improved pinch strength (with mirror +6.9%, p>0.1; without +21.9%, p=0.026). This preliminary study demonstrates the feasibility of mirror therapy in children with hemiplegia and that it may improve strength and dynamic function of the paretic arm. © The Authors. Developmental Medicine & Child Neurology © 2011 Mac Keith Press.

Single-site access robot-assisted epicardial mapping with a snake robot: preparation and first clinical experience.

PubMed

Neuzil, Petr; Cerny, Stepan; Kralovec, Stepan; Svanidze, Oleg; Bohuslavek, Jan; Plasil, Petr; Jehlicka, Pavel; Holy, Frantisek; Petru, Jan; Kuenzler, Richard; Sediva, Lucie

2013-06-01

CardioARM, a highly flexible "snakelike" medical robotic system (Medrobotics, Raynham, MA), has been developed to allow physicians to view, access, and perform complex procedures intrapericardially on the beating heart through a single-access port. Transthoracic epicardial catheter mapping and ablation has emerged as a strategy to treat arrhythmias, particularly ventricular arrhythmias, originating from the epicardial surface. The aim of our investigation was to determine whether the CardioARM could be used to diagnose and treat ventricular tachycardia (VT) of epicardial origin. Animal and clinical studies of the CardioARM flexible robot were performed in hybrid surgical-electrophysiology settings. In a porcine model study, single-port pericardial access, navigation, mapping, and ablation were performed in nine animals. The device was then used in a small, single-center feasibility clinical study. Three patients, all with drug-refractory VT and multiple failed endocardial ablation attempts, underwent epicardial mapping with the flexible robot. In all nine animals, navigation, mapping, and ablation were successful without hemodynamic compromise. In the human study, all three patients demonstrated a favorable safety profile, with no major adverse events through a 30-day follow-up. Two cases achieved technical success, in which an electroanatomic map of the epicardial ventricle surface was created; in the third case, blood obscured visualization. These results, although based on a limited number of experimental animals and patients, show promise and suggest that further clinical investigation on the use of the flexible robot in patients requiring epicardial mapping of VT is warranted.

Combination Varenicline and Lorcaserin for Tobacco Dependence Treatment and Weight Gain Prevention in Overweight and Obese Smokers: A Pilot Study.

PubMed

Hurt, Ryan T; Croghan, Ivana T; Schroeder, Darrell R; Hays, J Taylor; Choi, Doo-Sup; Ebbert, Jon O

2017-08-01

Post-cessation weight gain (PCWG) is a major barrier to maintaining abstinence, especially in weight-concerned smokers. Varenicline is the most effective medication for smoking cessation but has minimal impact on PCWG. Lorcaserin is an FDA-approved medication for weight management in overweight or obese patients which also provides a noticeable benefit in treating drug dependence. We hypothesized that combining varenicline with lorcaserin may help prevent PCWG. We conducted an open-label, single arm, Phase II clinical pilot study to obtain preliminary data on the safety and effectiveness of combination varenicline and lorcaserin in preventing PCWG in overweight and obese smokers. Twenty overweight or obese (body mass index 27-40 kg/m2) cigarette smokers were enrolled. The primary outcomes were weight and waist circumference (WC) changes at 12 and 26 weeks in smokers meeting criteria for prolonged smoking abstinence. All participants received open-label varenicline (1 mg twice a day) and lorcaserin (10 mg twice a day) for 12 weeks with follow-up at 26 weeks. Ten subjects met criteria for prolonged smoking abstinence at 12 weeks (50%) and 6 at 26 weeks (30%). Among those achieving prolonged smoking abstinence at 12 weeks, WC was +0.2 ± 6.0 cm (90% CI; -2.9, +3.4) and weight gain was +1.1 ± 3.9 kg (90% CI; -0.9, +3.1). Weight gain and WC increases following prolonged smoking abstinence may be reduced among overweight and obese smokers using combination varenicline and lorcaserin. This combinatory treatment warrants further research in the obese and weight-concerned smoking population. This is the first published prospective pilot study to evaluate lorcaserin for use in reducing PCWG in overweight and obese smokers. When combined with varenicline, lorcaserin minimized PCWG and increases in WC. In addition to the benefit on PCWG reduction, lorcaserin may be a potential new pharmacological treatment for smoking cessation and warrants further larger studies. © The Author 2016. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Cuff Pressure Pain Detection Is Associated with Both Sex and Physical Activity Level in Nonathletic Healthy Subjects.

PubMed

Lemming, Dag; Börsbo, Björn; Sjörs, Anna; Lind, Eva-Britt; Arendt-Nielsen, Lars; Graven-Nielsen, Thomas; Gerdle, Björn

2017-08-01

The aim of this study was to evaluate pressure pain sensitivity on leg and arm in 98 healthy persons (50 women) using cuff algometry. Furthermore, associations with sex and physical activity level were investigated. Normal physical activity level was defined as Godin Leisure-Time Exercise Questionnaire (GLTEQ) score ≤ 45 and high activity level as GLTEQ > 45. A pneumatic double-chamber cuff was placed around the arm or leg where a single chamber was inflated. The cuff inflation rate (1 kPa/s) was constant, and pain intensity was registered continuously on a 10 cm electronic visual analogue scale (VAS). The pain detection threshold (PDT) was defined as when the pressure was perceived as painful, and pain tolerance (PTT) was when the subject terminated the cuff inflation. For PTT, the corresponding VAS score was recorded (VAS-PTT). The protocol was repeated with two chambers inflated. Only single cuff results are given. For women compared with men, the PDT was lower when assessed in the arm ( P = 0.002), PTTs were lower in the arm and leg ( P < 0.001), and the VAS-PTT was higher in the arm and leg ( P < 0.033). Highly active participants compared with less active had higher PDT ( P = 0.027) in the leg. Women showed facilitated spatial summation ( P < 0.014) in the arm and leg and a steeper VAS slope (i.e., the slope of the VAS pressure curve between PDT and PPT) in the arm and leg ( P < 0.003). This study indicates that reduced pressure pain sensitivity is associated both with male sex and physical activity level. © 2017 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Ribociclib plus letrozole in early breast cancer: A presurgical, window-of-opportunity study.

PubMed

Curigliano, G; Gómez Pardo, P; Meric-Bernstam, F; Conte, P; Lolkema, M P; Beck, J T; Bardia, A; Martínez García, M; Penault-Llorca, F; Dhuria, S; Tang, Z; Solovieff, N; Miller, M; Di Tomaso, E; Hurvitz, S A

2016-08-01

Cyclin D-cyclin-dependent kinase (CDK) 4/6-inhibitor of CDK4/6-retinoblastoma (Rb) pathway hyperactivation is associated with hormone receptor-positive (HR+) breast cancer (BC). This study assessed the biological activity of ribociclib (LEE011; CDK4/6 inhibitor) plus letrozole compared with single-agent letrozole in the presurgical setting. Postmenopausal women (N = 14) with resectable, HR+, human epidermal growth factor receptor 2-negative (HER2-) early BC were randomized 1:1:1 to receive 2.5 mg/day letrozole alone (Arm 1), or with 400 or 600 mg/day ribociclib (Arm 2 or 3). Circulating tumor DNA and tumor biopsies were collected at baseline and, following 14 days of treatment, prior to or during surgery. The primary objective was to assess antiproliferative response per Ki67 levels in Arms 2 and 3 compared with Arm 1. Additional assessments included safety, pharmacokinetics, and genetic profiling. Mean decreases in the Ki67-positive cell fraction from baseline were: Arm 1 69% (range 38-100%; n = 2), Arm 2 96% (range 78-100%; n = 6), Arm 3 92% (range 75-100%; n = 3). Decreased phosphorylated Rb levels and CDK4, CDK6, CCND2, CCND3, and CCNE1 gene expression were observed following ribociclib treatment. Ribociclib and letrozole pharmacokinetic parameters were consistent with single-agent data. The ribociclib plus letrozole combination was well tolerated, with no Grade 3/4 adverse events over the treatment. The results suggest absence of a drug-drug interaction between ribociclib and letrozole and indicate ribociclib plus letrozole may reduce Ki67 expression in HR+, HER2- BC (NCT01919229). Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Role of arm motion in feet-in-place balance recovery.

PubMed

Cheng, Kuangyou B; Wang, Kuan-Mao; Kuo, Shih-Yu

2015-09-18

Although considerable arm movements have been observed at loss of balance, research on standing balance focused primarily on the ankle and hip strategies. This study aimed to investigate the effect of arm motion on feet-in-place balance recovery. Participants stood on a single force plate and leaned forward with a straight body posture. They were then released from three forward-lean angles and regained balance without moving their forefeet under arm-swing (AS) and arm-constrained (AC) conditions. Higher success rates and shorter recovery times were found with arm motion under moderate balance perturbations. Recovery time was significantly correlated with peak linear momentum of the arms. Circumduction arm motion caused initial shoulder extension (backward arm movement) to generate reaction forces to pull the body forward, but later forward linear momentum of the arms helped move the whole body backward to avoid forward falling. However, greater lean angles increased difficulty in balance recovery, making the influences of the arms less significant. Since arm motions were observed in all participants with significantly enhanced performance under moderate balance perturbation, it was concluded that moving the arms should also be considered (together with the ankles and hips) as an effective strategy for balance recovery. Copyright © 2015 Elsevier Ltd. All rights reserved.

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-15

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

Antibody-ribosome-mRNA (ARM) complexes as efficient selection particles for in vitro display and evolution of antibody combining sites.

PubMed Central

He, M; Taussig, M J

1997-01-01

We describe a rapid, eukaryotic, in vitro method for selection and evolution of antibody combining sites using antibody-ribosome-mRNA (ARM) complexes as selection particles. ARMs carrying single-chain (VH/K) binding fragments specific for progesterone were selected using antigen-coupled magnetic beads; selection simultaneously captured the genetic information as mRNA, making it possible to generate and amplify cDNA by single-step RT-PCR on the ribosome-bound mRNA for further manipulation. Using mutant libraries, antigen-binding ARMs were enriched by a factor of 10(4)-10(5)-fold in a single cycle, with further enrichment in repeated cycles. While demonstrated here for antibodies, the method has the potential to be applied equally for selection of receptors or peptides from libraries. PMID:9396828

Antibody-ribosome-mRNA (ARM) complexes as efficient selection particles for in vitro display and evolution of antibody combining sites.

PubMed

He, M; Taussig, M J

1997-12-15

We describe a rapid, eukaryotic, in vitro method for selection and evolution of antibody combining sites using antibody-ribosome-mRNA (ARM) complexes as selection particles. ARMs carrying single-chain (VH/K) binding fragments specific for progesterone were selected using antigen-coupled magnetic beads; selection simultaneously captured the genetic information as mRNA, making it possible to generate and amplify cDNA by single-step RT-PCR on the ribosome-bound mRNA for further manipulation. Using mutant libraries, antigen-binding ARMs were enriched by a factor of 10(4)-10(5)-fold in a single cycle, with further enrichment in repeated cycles. While demonstrated here for antibodies, the method has the potential to be applied equally for selection of receptors or peptides from libraries.

A novel robotic platform for single-port abdominal surgery

NASA Astrophysics Data System (ADS)

Singh, Satwinder; Cheung, Jo L. K.; Sreedhar, Biji; Hoa, Xuyen Dai; Ng, Hoi Pang; Yeung, Chung Kwong

2018-03-01

In this paper, a novel robot-assisted platform for single-port minimally invasive surgery is presented. A miniaturized seven degrees of freedom (dof) fully internalized in-vivo actuated robotic arm is designed. Due to in-vivo actuation, the system has a smaller footprint and can generate 20 N of gripping force. The complete work envelop of the robotic arms is 252 mm × 192 mm × 322 m. With the assistance of the cannula-swivel system, the robotic arms can also be re-positioned and have multi-quadrant reachability without any additional incision. Surgical tasks, such as lifting, gripping suturing and knot tying that are commonly used in a standard surgical procedure, were performed to verify the dexterity of the robotic arms. A single-port trans-abdominal cholecystectomy in a porcine model was successfully performed to further validate its functionality.

Development of a Tailored HIV Prevention Intervention for Single Young Men Who Have Sex With Men Who Meet Partners Online: Protocol for the myDEx Project.

PubMed

Bauermeister, Jose Arturo; Tingler, Ryan C; Demers, Michele; Harper, Gary W

2017-07-19

New cases of human immunodeficiency virus (HIV) among young men who have sex with men (YMSM), aged 18 to 24, underscore the importance of developmentally-informed HIV programs for YMSM. We developed an online intervention focused on risk reduction strategies across different sexual partner types. Intervention activities focus on assisting YMSM reflect on their partner-seeking behaviors, develop sexual decision-making rules to reduce their HIV risks, and consider the adoption of HIV prevention behaviors. This pilot, randomized controlled trial (RCT) aims to examine the feasibility, acceptability, and preliminary efficacy of a tailored, Web-based HIV prevention intervention for single YMSM. We designed a prospective RCT of online-recruited cis-gender men (N=180) who reported recent unprotected anal intercourse, self-report as HIV negative or are unaware of their HIV status, and meet sexual partners through online dating apps. Individuals in the control arm receive an attention-control condition that includes HIV/sexually transmitted infection (STI) information currently available on sex education websites. Individuals in the intervention arm receive a 6-session Web-based program tailored on their demographic information, partner-seeking behaviors and relationship desires, and prior sexual attitudes and behaviors. This tailored content will match HIV prevention messages and safer sex skills with YMSM's outcome expectancies when meeting new partners and thereby help them consider how to integrate safer sex practices into different partner types. Study assessments are taken at baseline, 30-, 60-, and 90-day follow-ups. Intervention acceptability and preliminary efficacy will be explored in sexual risk behaviors and HIV/STI testing. The RCT launched in November 2016 and is ongoing. To date, 180 eligible individuals have been enrolled, consented, and randomized. Of the 120 individuals in the intervention arm, 51.7% (62/120) identify as non-Hispanic white and half of the control arm identifies as non-Hispanic white. There were no differences observed by arm for race and/or ethnicity, age, or sexual orientation. Although there are in-person evidence-based interventions with proven efficacy for YMSM, few HIV/STI prevention interventions delivered online exist. Online interventions may ease access to comprehensive HIV/STI education among YMSM and allow personalized content to be delivered. The online intervention that we developed, myDEx, aims to alleviate the gaps within HIV prevention for YMSM by utilizing tailored, Web-based content with the goal of developing skills for same-sex dating and relationship building, while reducing their risks for HIV/STI. ClinicalTrials.gov NCT02842060; https://clinicaltrials.gov/ct2/show/NCT02842060 (Archived by WebCite at http://www.webcitation.org/6rcJdxF9v). ©Jose Arturo Bauermeister, Ryan C Tingler, Michele Demers, Gary W Harper. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 19.07.2017.

Tolerability of the combination of ginger (Zingiber officinalis), gentian (Gentiana lutea) and turmeric (Curcuma longa) in patients with cancer-associated anorexia.

PubMed

Sanatani, Michael; Younus, Jawaid; Stitt, Larry; Malik, Nazish

2015-03-01

Anorexia is a common symptom for patients with advanced cancer. Gentian, ginger, and turmeric have traditionally been used to stimulate appetite. We tested these agents in combination, in a pilot study to assess tolerability in patients indicating 4/10 or worse anorexia on the Edmonton Symptom Assessment System, and who were not currently on chemotherapy. We collected exploratory data on the patient's appetite using a visual analogue scale. Between 2009 and 2012, 17 patients were enrolled in arm 1 (turmeric 1 g and ginger 1 g orally twice daily, and gentiana lutea tincture 1 mL three times a day, for 14 days). The three patients enrolled in arm 2 received the same doses of ginger and turmeric but no gentian. All patients completed a daily appetite diary and a weekly symptom assessment. In arm 1, seven patients (41%) completed treatment. Seven patients (41%) stopped early because of unacceptable toxicity or patient-initiated discontinuation, and 3 stopped because of other reasons. All patients in arm 2 stopped taking the study medication within few days of starting the treatment, leading the study committee to recommend stopping the trial. The most common adverse effects attributed to study drugs were nausea (6 patients), vomiting (3), fatigue (3), diarrhea (2) and bloating (2). There was no statistically significant effect seen on appetite. At the doses used in this study, the combination of ginger, turmeric, and gentian is not tolerated well in cancer patients. Future studies should use fewer agents or lower doses.

A prospective randomized phase II study comparing metronomic chemotherapy with chemotherapy (single agent cisplatin), in patients with metastatic, relapsed or inoperable squamous cell carcinoma of head and neck.

PubMed

Patil, Vijay Maruti; Noronha, Vanita; Joshi, Amit; Muddu, Vamshi Krishna; Dhumal, Sachin; Bhosale, Bharatsingh; Arya, Supreeta; Juvekar, Shashikant; Banavali, Shripad; D'Cruz, Anil; Bhattacharjee, Atanu; Prabhash, Kumar

2015-03-01

Cetuximab based treatment is the recommended chemotherapy for head and neck squamous cell cancers in the palliative setting. However, due to financial constraints, intravenous (IV) chemotherapy without cetuximab is commonly used in lesser developed countries. We believe that oral metronomic chemotherapy may be safer and more effective in this setting. We conducted an open label, superiority, parallel design, randomized phase II trial comparing oral MCT [daily celecoxib (200mg twice daily) and weekly methotrexate (15mg/m(2))] to intravenous single agent cisplatin (IP) (75mg/m(2)) given 3 weekly. Eligible patients had head and neck cancers requiring palliative chemotherapy with ECOG PS 0-2 and adequate organ functions who could not afford cetuximab. The primary end point was progression-free survival. 110 Patients were recruited between July 2011 to May 2013, 57 randomized to the MCT arm and 53 to the IP arm. Patients in the MCT arm had significantly longer PFS (median 101 days, 95% CI: 58.2-143.7 days) compared to the IP arm (median 66 days, 95% CI; 55.8-76.1 days) (p=0.014). The overall survival (OS) was also increased significantly in the MCT arm (median 249 days, 95% CI: 222.5-275.5 days) compared to the IP arm (median 152 days, 95% CI: 104.2-199.8 days) (p=0.02). There were fewer grade 3/4 adverse effects with MCT, which was not significant. (18.9% vs. 31.4%, P=0.14). Oral metronomic chemotherapy has significantly better PFS and OS than single agent platinum in the palliative setting. Copyright © 2014 Elsevier Ltd. All rights reserved.

[Anthropometric indices and nutritional status of low income school children in a municipality of the State of Rio de Janeiro (Brazil): a pilot study].

PubMed

dos Anjos, L A

1989-06-01

The growth and nutritional status of 185 school-aged children (97 boys and 88 girls) of low socio-economic level in Nova Iguaçú, State of Rio de Janeiro, Brazil, were studied. Nutritional anthropometry identified 3.52 and 6.25% of the children as suffering from wasting and stunting, respectively. These prevalences of malnutrition were comparable to those described in pre-school children living in a "favela" (shanty town) of Rio de Janeiro. In general, the median height fell below the 25th centile of the international standard of growth. The value of 10 year-old boys fell below the 10th centile. The mean values of weight and height of these children were comparable to those of children from the Northeastern region of Brazil ("Nordeste"), higher than those found for children in the State of Paraíba, Brazil, and lower than those for middle-class children of the State of S. Paulo. Skinfold thickness, arm circumference, and arm fat area data were higher in girls than boys. However, arm muscle are values in boys were superior in comparison to those of girls.

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

NASA Technical Reports Server (NTRS)

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

1983-01-01

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

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

Noninvasive lifting of arm, thigh, and knee skin with transcutaneous intense focused ultrasound.

PubMed

Alster, Tina S; Tanzi, Elizabeth L

2012-05-01

Transcutaneous intense focused ultrasound is a novel Food and Drug Administration-approved technology for noninvasive skin tightening of the face and neck. No studies have reported on its safety and effectiveness on nonfacial areas. Eighteen paired areas (6 each) on the upper arms, medial thighs, and extensor knees were randomly treated with two different transducers (4.0 MHz, 4.5-mm focal depth and 7.0 MHz, 3.0-mm focal depth). One side was randomly assigned to receive a single pass (single plane) of microthermal coagulation zones over the involved area with the 4.0 MHz, 4.5-mm-depth transducer, and the contralateral side was assigned to receive consecutive single passes (dual plane) using both transducers (4.0 MHz, 4.5-mm depth followed by 7.0 MHz, 3.0-mm depth). Two independent masked assessors determined clinical improvement scores using comparative standardized photographs obtained at baseline and 3 and 6 months after treatment. Subjective assessments of clinical improvement and side effects of treatment were obtained. Global assessment scores revealed significant improvement in all treated areas, with the upper arms and knees demonstrating more skin lifting and tightening than the thighs. Areas receiving dual-plane treatment had slightly better clinical scores than those receiving single-plane treatment in all three sites. Clinical scores from single-plane and dual-plane treated areas continued to improve between 3 and 6 months after treatment. Side effects were mild and transient and included erythema, warmth, and skin tenderness. Rare focal bruising was noted in two patients on the upper arms that resolved within 7 days. No other side effects were reported or observed. Transcutaneous intense focused ultrasound can be safely and effectively used to improve the clinical appearance (texture and contour) of the upper arms, extensor knees, and medial thighs. © 2012 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.

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.

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

PubMed

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

2016-01-01

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

Octopus vulgaris uses visual information to determine the location of its arm.

PubMed

Gutnick, Tamar; Byrne, Ruth A; Hochner, Binyamin; Kuba, Michael

2011-03-22

Octopuses are intelligent, soft-bodied animals with keen senses that perform reliably in a variety of visual and tactile learning tasks. However, researchers have found them disappointing in that they consistently fail in operant tasks that require them to combine central nervous system reward information with visual and peripheral knowledge of the location of their arms. Wells claimed that in order to filter and integrate an abundance of multisensory inputs that might inform the animal of the position of a single arm, octopuses would need an exceptional computing mechanism, and "There is no evidence that such a system exists in Octopus, or in any other soft bodied animal." Recent electrophysiological experiments, which found no clear somatotopic organization in the higher motor centers, support this claim. We developed a three-choice maze that required an octopus to use a single arm to reach a visually marked goal compartment. Using this operant task, we show for the first time that Octopus vulgaris is capable of guiding a single arm in a complex movement to a location. Thus, we claim that octopuses can combine peripheral arm location information with visual input to control goal-directed complex movements. Copyright © 2011 Elsevier Ltd. All rights reserved.

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

PubMed Central

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

2015-01-01

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

Organization of octopus arm movements: a model system for studying the control of flexible arms.

PubMed

Gutfreund, Y; Flash, T; Yarom, Y; Fiorito, G; Segev, I; Hochner, B

1996-11-15

Octopus arm movements provide an extreme example of controlled movements of a flexible arm with virtually unlimited degrees of freedom. This study aims to identify general principles in the organization of these movements. Video records of the movements of Octopus vulgaris performing the task of reaching toward a target were studied. The octopus extends its arm toward the target by a wave-like propagation of a bend that travels from the base of the arm toward the tip. Similar bend propagation is seen in other octopus arm movements, such as locomotion and searching. The kinematics (position and velocity) of the midpoint of the bend in three-dimensional space were extracted using the direct linear transformation algorithm. This showed that the bend tends to move within a single linear plane in a simple, slightly curved path connecting the center of the animal's body with the target location. Approximately 70% of the reaching movements demonstrated a stereotyped tangential velocity profile. An invariant profile was observed when movements were normalized for velocity and distance. Two arms, extended together in the same behavioral context, demonstrated identical velocity profiles. The stereotyped features of the movements were also observed in spontaneous arm extensions (not toward an external target). The simple and stereotypic appearance of the bend trajectory suggests that the position of the bend in space and time is the controlled variable. We propose that this strategy reduces the immense redundancy of the octopus arm movements and hence simplifies motor control.

C-arm positioning using virtual fluoroscopy for image-guided surgery

NASA Astrophysics Data System (ADS)

de Silva, T.; Punnoose, J.; Uneri, A.; Goerres, J.; Jacobson, M.; Ketcha, M. D.; Manbachi, A.; Vogt, S.; Kleinszig, G.; Khanna, A. J.; Wolinsky, J.-P.; Osgood, G.; Siewerdsen, J. H.

2017-03-01

Introduction: Fluoroscopically guided procedures often involve repeated acquisitions for C-arm positioning at the cost of radiation exposure and time in the operating room. A virtual fluoroscopy system is reported with the potential of reducing dose and time spent in C-arm positioning, utilizing three key advances: robust 3D-2D registration to a preoperative CT; real-time forward projection on GPU; and a motorized mobile C-arm with encoder feedback on C-arm orientation. Method: Geometric calibration of the C-arm was performed offline in two rotational directions (orbit α, orbit β). Patient registration was performed using image-based 3D-2D registration with an initially acquired radiograph of the patient. This approach for patient registration eliminated the requirement for external tracking devices inside the operating room, allowing virtual fluoroscopy using commonly available systems in fluoroscopically guided procedures within standard surgical workflow. Geometric accuracy was evaluated in terms of projection distance error (PDE) in anatomical fiducials. A pilot study was conducted to evaluate the utility of virtual fluoroscopy to aid C-arm positioning in image guided surgery, assessing potential improvements in time, dose, and agreement between the virtual and desired view. Results: The overall geometric accuracy of DRRs in comparison to the actual radiographs at various C-arm positions was PDE (mean ± std) = 1.6 ± 1.1 mm. The conventional approach required on average 8.0 ± 4.5 radiographs spent "fluoro hunting" to obtain the desired view. Positioning accuracy improved from 2.6o ± 2.3o (in α) and 4.1o ± 5.1o (in β) in the conventional approach to 1.5o ± 1.3o and 1.8o ± 1.7o, respectively, with the virtual fluoroscopy approach. Conclusion: Virtual fluoroscopy could improve accuracy of C-arm positioning and save time and radiation dose in the operating room. Such a system could be valuable to training of fluoroscopy technicians as well as intraoperative use in fluoroscopically guided procedures.

Are large clinical trials in orthopaedic trauma justified?

PubMed

Sprague, Sheila; Tornetta, Paul; Slobogean, Gerard P; O'Hara, Nathan N; McKay, Paula; Petrisor, Brad; Jeray, Kyle J; Schemitsch, Emil H; Sanders, David; Bhandari, Mohit

2018-04-20

The objective of this analysis is to evaluate the necessity of large clinical trials using FLOW trial data. The FLOW pilot study and definitive trial were factorial trials evaluating the effect of different irrigation solutions and pressures on re-operation. To explore treatment effects over time, we analyzed data from the pilot and definitive trial in increments of 250 patients until the final sample size of 2447 patients was reached. At each increment we calculated the relative risk (RR) and associated 95% confidence interval (CI) for the treatment effect, and compared the results that would have been reported at the smaller enrolments with those seen in the final, adequately powered study. The pilot study analysis of 89 patients and initial incremental enrolments in the FLOW definitive trial favored low pressure compared to high pressure (RR: 1.50, 95% CI: 0.75-3.04; RR: 1.39, 95% CI: 0.60-3.23, respectively), which is in contradiction to the final enrolment, which found no difference between high and low pressure (RR: 1.04, 95% CI: 0.81-1.33). In the soap versus saline comparison, the FLOW pilot study suggested that re-operation rate was similar in both the soap and saline groups (RR: 0.98, 95% CI: 0.50-1.92), whereas the FLOW definitive trial found that the re-operation rate was higher in the soap treatment arm (RR: 1.28, 95% CI: 1.04-1.57). Our findings suggest that studies with smaller sample sizes would have led to erroneous conclusions in the management of open fracture wounds. NCT01069315 (FLOW Pilot Study) Date of Registration: February 17, 2010, NCT00788398 (FLOW Definitive Trial) Date of Registration: November 10, 2008.

Acute Whiplash Injury Study (AWIS): a protocol for a cluster randomised pilot and feasibility trial of an Active Behavioural Physiotherapy Intervention in an insurance private setting

PubMed Central

Wiangkham, Taweewat; Duda, Joan; Haque, M Sayeed; Price, Jonathan; Rushton, Alison

2016-01-01

Introduction Whiplash-associated disorder (WAD) causes substantial social and economic burden internationally. Up to 60% of patients with WAD progress to chronicity. Research therefore needs to focus on effective management in the acute stage to prevent the development of chronicity. Approximately 93% of patients are classified as WADII (neck complaint and musculoskeletal sign(s)), and in the UK, most are managed in the private sector. In our recent systematic review, a combination of active and behavioural physiotherapy was identified as potentially effective in the acute stage. An Active Behavioural Physiotherapy Intervention (ABPI) was developed through combining empirical (modified Delphi study) and theoretical (social cognitive theory focusing on self-efficacy) evidence. This pilot and feasibility trial has been designed to inform the design of an adequately powered definitive randomised controlled trial. Methods and analysis Two parallel phases. (1) An external pilot and feasibility cluster randomised double-blind (assessor and participants), parallel two-arm (ABPI vs standard physiotherapy) clinical trial to evaluate procedures and feasibility. Six UK private physiotherapy clinics will be recruited and cluster randomised by a computer-generated randomisation sequence. Sixty participants (30 each arm) will be assessed at recruitment (baseline) and at 3 months postbaseline. The planned primary outcome measure is the neck disability index. (2) An embedded exploratory qualitative study using semistructured indepth interviews (n=3–4 physiotherapists) and a focus group (n=6–8 patients) and entailing the recruitment of purposive samples will explore perceptions of the ABPI. Quantitative data will be analysed descriptively. Qualitative data will be coded and analysed deductively (identify themes) and inductively (identify additional themes). Ethics and dissemination This trial is approved by the University of Birmingham Ethics Committee (ERN_15-0542). Trial registration number ISRCTN84528320. PMID:27412105

Acute Whiplash Injury Study (AWIS): a protocol for a cluster randomised pilot and feasibility trial of an Active Behavioural Physiotherapy Intervention in an insurance private setting.

PubMed

Wiangkham, Taweewat; Duda, Joan; Haque, M Sayeed; Price, Jonathan; Rushton, Alison

2016-07-13

Whiplash-associated disorder (WAD) causes substantial social and economic burden internationally. Up to 60% of patients with WAD progress to chronicity. Research therefore needs to focus on effective management in the acute stage to prevent the development of chronicity. Approximately 93% of patients are classified as WADII (neck complaint and musculoskeletal sign(s)), and in the UK, most are managed in the private sector. In our recent systematic review, a combination of active and behavioural physiotherapy was identified as potentially effective in the acute stage. An Active Behavioural Physiotherapy Intervention (ABPI) was developed through combining empirical (modified Delphi study) and theoretical (social cognitive theory focusing on self-efficacy) evidence. This pilot and feasibility trial has been designed to inform the design of an adequately powered definitive randomised controlled trial. Two parallel phases. (1) An external pilot and feasibility cluster randomised double-blind (assessor and participants), parallel two-arm (ABPI vs standard physiotherapy) clinical trial to evaluate procedures and feasibility. Six UK private physiotherapy clinics will be recruited and cluster randomised by a computer-generated randomisation sequence. Sixty participants (30 each arm) will be assessed at recruitment (baseline) and at 3 months postbaseline. The planned primary outcome measure is the neck disability index. (2) An embedded exploratory qualitative study using semistructured indepth interviews (n=3-4 physiotherapists) and a focus group (n=6-8 patients) and entailing the recruitment of purposive samples will explore perceptions of the ABPI. Quantitative data will be analysed descriptively. Qualitative data will be coded and analysed deductively (identify themes) and inductively (identify additional themes). This trial is approved by the University of Birmingham Ethics Committee (ERN_15-0542). ISRCTN84528320. 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/

PILOT-SCALE INCINERATION OF BALLISTIC MISSILE LIQUID PROPELLANT COMPONENTS

EPA Science Inventory

The U.S. Department of Defense (DOD) recently concluded agreements with the Ukraine and the Russian Federation under which the DOD is committed to providing both former Soviet Union (FSU) states with equipment and other aid for use in eliminating their strategic offensive arms in...

77 FR 27863 - Privacy Act of 1974; System of Records

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-11

... Therapy (CWT), HUD/VA Prevention pilot, and Supportive Services for Veterans and Families (SSVF). This... Veterans and their immediate family members, members of the armed services, current and former employees... Location Addiction Severity Index Veteran Affairs Medical Center, 7180 Highland Drive, Pittsburgh, PA 15206...

A novel Tetra-primer ARMS-PCR based assay for genotyping SNP rs12303764(G/T) of human Unc-51 like kinase 1 gene.

PubMed

Randhawa, Rohit; Duseja, Ajay; Changotra, Harish

2017-02-01

Various case-control studies have shown association of single nucleotide polymorphism rs12303764(G/T) in ULK1 with crohn's disease. The techniques used in these studies were time consuming, complicated and require sophisticated/expensive instruments. Therefore, in order to overcome these problems, we have developed a new, rapid and cost effective Tetra-primer ARMS-PCR assay to genotype single nucleotide polymorphism rs12303764(G/T) of ULK1 gene. We manually designed allele specific primers. DNA fragment amplified using outer primers was sequenced to obtain samples with known genotypes (GG, GT and TT) for further use in the development of T-ARMS-PCR assay. Amplification conditions were optimized for parameters; annealing temperature, Taq DNA polymerase and primers. The developed T-ARMS-PCR assay was applied to genotype one hundred samples from healthy individuals. Genotyping results of 10 DNA samples from healthy individuals for rs12303764(G/T) by T-ARMS-PCR assay and sequencing were concordant. The newly developed assay was further applied to genotype samples from 100 healthy individuals of North Indian origin. Genotype frequencies were 9, 34 and 57 % for GG, GT and TT, respectively. Allele frequencies were 0.26 and 0.74 for G and T, respectively. The allele frequencies were in Hardy-Weinberg's equilibrium (p = 0.2443). T-ARMS-PCR assay developed in our laboratory for genotyping rs12303764 (G/T) of ULK1 gene is time saving and cost-effective as compared to the available methods. Furthermore, this is the first study reporting allelic and genotype frequencies of ULK1 rs12303764 (G/T) variants in North Indian population.

Development and initial assessment of objective fatigue measures for apple harvest work.

PubMed

Earle-Richardson, Giulia; Jenkins, Paul L; Strogatz, David; Bell, Erin M; May, John J

2006-11-01

Previous research has shown that neck, back and shoulder musculoskeletal strain is a major occupational health problem affecting migrant orchard harvest workers. Researchers seek to measure the effect of an ergonomic modification to the apple picking bucket on muscle fatigue, however objective measures for use in the orchard are not yet available. The purpose of this study is to develop simple back, shoulder or arm strength measures, which detect statistically significant drops in strength over one workday. Candidate muscle strength measures were piloted in the laboratory, adapted for the orchard and evaluated (n=102). Data were analyzed for morning to afternoon fatigue, and for correlation between fatigue score and hours worked. In the laboratory, the timed arm hold (35.7% time reduction, 95% CI: 21.81-49.61), and the timed spinal extension (31.8% time reduction, 95% CI: 23.54-39.96) showed significant fatigue. In the orchard (n=102), only the timed arm hold showed significant (11.4%, p<.0001) fatigue. The potential effect of field conditions and subject motivation on these results needs further exploration.

Patient-Centered Tablet Application for Improving Medication Adherence after a Drug-Eluting Stent.

PubMed

Shah, Vicki; Dileep, Anandu; Dickens, Carolyn; Groo, Vicki; Welland, Betty; Field, Jerry; Baumann, Matthew; Flores, Jose D; Shroff, Adhir; Zhao, Zhongsheng; Yao, Yingwei; Wilkie, Diana J; Boyd, Andrew D

2016-01-01

This study's objective was to evaluate a patient-centered educational electronic tablet application, "My Interventional Drug-Eluting Stent Educational App" (MyIDEA) to see if there was an increase in patient knowledge about dual antiplatelet therapy (DAPT) and medication possession ratio (MPR) compared to treatment as usual. In a pilot project, 24 elderly (≥50 years old) research participants were recruited after a drug-eluting stent. Eleven were randomized to the control arm and 13 to the interventional arm. All the participants completed psychological and knowledge questionnaires. Adherence was assessed through MPR, which was calculated at 3 months for all participants who were scheduled for second and third follow-up visits. Relative to control, the interventional group had a 10% average increase in MPR. As compared to the interventional group, more patients in the control group had poor adherence (<80% MPR). The psychological data revealed a single imbalance in anxiety between the control and interventional groups. On average, interventional participants spent 21 min using MyIDEA. Consumer health informatics has enabled us to engage patients with their health data using novel methods. Consumer health technology needs to focus more on patient knowledge and engagement to improve long-term health. MyIDEA takes a unique approach in targeting DAPT from the onset. MyIDEA leverages patient-centered information with clinical care and the electronic health record highlighting the patients' role as a team member in their own health care. The patients think critically about adverse events and how to solve issues before leaving the hospital.

Changes in arm-hand function and arm-hand skill performance in patients after stroke during and after rehabilitation.

PubMed

Franck, Johan Anton; Smeets, Rob Johannes Elise Marie; Seelen, Henk Alexander Maria

2017-01-01

Arm-hand rehabilitation programs applied in stroke rehabilitation frequently target specific populations and thus are less applicable in heterogeneous patient populations. Besides, changes in arm-hand function (AHF) and arm-hand skill performance (AHSP) during and after a specific and well-described rehabilitation treatment are often not well evaluated. This single-armed prospective cohort study featured three subgroups of stroke patients with either a severely, moderately or mildly impaired AHF. Rehabilitation treatment consisted of a Concise_Arm_and_hand_ Rehabilitation_Approach_in_Stroke (CARAS). Measurements at function and activity level were performed at admission, clinical discharge, 3, 6, 9 and 12 months after clinical discharge. Eighty-nine stroke patients (M/F:63/23; mean age:57.6yr (+/-10.6); post-stroke time:29.8 days (+/-20.1)) participated. All patients improved on AHF and arm-hand capacity during and after rehabilitation, except on grip strength in the severely affected subgroup. Largest gains occurred in patients with a moderately affected AHF. As to self-perceived AHSP, on average, all subgroups improved over time. A small percentage of patients declined regarding self-perceived AHSP post-rehabilitation. A majority of stroke patients across the whole arm-hand impairment severity spectrum significantly improved on AHF, arm-hand capacity and self-perceived AHSP. These were maintained up to one year post-rehabilitation. Results may serve as a control condition in future studies.

Time course of upper limb function and return-to-work post-radiotherapy in young adults with breast cancer: a pilot randomized control trial on effects of targeted exercise program.

PubMed

Ibrahim, Marize; Muanza, Thierry; Smirnow, Nadia; Sateren, Warren; Fournier, Beatrice; Kavan, Petr; Palumbo, Michael; Dalfen, Richard; Dalzell, Mary-Ann

2017-12-01

Breast cancer (BC) diagnosis in young adults (YA) is rising, and both disease and treatments are aggressive in this population. Evidence supports the use of physical activity in reducing shoulder dysfunction, which is common among BC survivors. A pilot randomized clinical trial was performed to determine the effectiveness of a 12-week post-radiation exercise program in minimizing upper extremity dysfunction in YA with BC. Participants were randomized to either an exercise arm or a control arm receiving standard care. Data was collected over six time points using: the Disability of Arm, Shoulder, and Hand (DASH); the Metabolic Equivalent of Task-hours per week (MET-hours/week), and a post hoc questionnaire on return to work. In total, 59 young women participated in the study (n = 29 exercise; n = 30 control). No statistically significant differences were found in overall DASH results between groups; however, those who underwent total mastectomy had residual upper limb dysfunction (p < 0.05). Both groups returned to pre-diagnosis activity levels by 18 months. Final evaluation showed that 86% of the women returned to work, and 89% resumed prior work activities with a decrease of 8.5 h/week. Although the short-term targeted exercise program had no effect on long-term upper limb function post-radiation, timing and program specificity may require consideration of tissue healing post-radiation and surgery type. The majority of participants returned to work, however not returning to pre-diagnosis work hours. Exercise interventions alone may not reverse the long-term sequelae of breast cancer treatment and allow young adult patients to return to work.

Goal-directed arm movements in children with fetal alcohol syndrome: a kinematic approach.

PubMed

Domellöf, E; Fagard, J; Jacquet, A-Y; Rönnqvist, L

2011-02-01

Although many studies have documented deficits in general motor functioning in children with fetal alcohol syndrome (FAS), few have employed detailed measurements to explore the specific nature of such disabilities. This pilot study explores whether three-dimensional (3D) kinematic analysis may generate increased knowledge of the effect of intrauterine alcohol exposure on motor control processes by detecting atypical upper-limb movement pattern specificity in children with FAS relative to typically developing (TD) children. Left and right arm and head movements during a sequential unimanual goal-directed precision task in a sample of children with FAS and in TD children were registered by an optoelectronic tracking system (ProReflex, Qualisys Inc.). Children with FAS demonstrated evidently poorer task performance compared with TD children. Additionally, analyses of arm movement kinematics revealed atypical spatio-temporal organization in the children with FAS. In general, they exhibited longer arm movement trajectories at both the proximal and distal level, faster velocities at the proximal level but slower at the distal level, and more segmented distal movements. Children with FAS also showed atypically augmented and fast head movements during the task performance. Findings indicate neuromotor deficits and developmental delay in goal-directed arm movements because of prenatal alcohol exposure. It is suggested that 3D kinematic analysis is a valid technique for furthering the understanding of motor control processes in children with FAS/fetal alcohol spectrum disorders. A combination with relevant neuroimaging techniques in future studies would enable a more clear-cut interpretation of how atypical movement patterns relate to underlying brain abnormalities. © 2010 The Author(s). European Journal of Neurology © 2010 EFNS.

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

ERIC Educational Resources Information Center

Newbery, Natasha; McCambridge, Jim; Strang, John

2007-01-01

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

Pilot test of an emotional education intervention component for sexual risk reduction.

PubMed

Ferrer, Rebecca A; Fisher, Jeffrey D; Buck, Ross; Amico, K Rivet

2011-09-01

Emotions are key predictors of sexual risk behavior but have been largely ignored in theory-based intervention development. The present study aims to evaluate whether the addition of an emotional education intervention component to a traditional social-cognitive safer sex intervention increases intervention efficacy, compared with both a social-cognitive only intervention and a no intervention control condition. Young adults were randomized in small groups to receive the social-cognitive-emotional (SCE) intervention, the social-cognitive (SC) intervention, or standard of care. Analyses of data from 176 participants indicated that intervention arms reported similar increased condom use compared with the no intervention control arm at 3 months' postintervention (β = .06, p = .41, d = 0.08). However, at 6 months' postintervention, individuals in the SCE intervention arm reported increased condom use compared with both the SC intervention (β = .27, p = .04, d = 0.38) and control arms (β = .37, p < .01; d = 0.56), demonstrating preliminary evidence that the addition of an emotional education component may facilitate sustained behavior change. An emotional education intervention module has the potential to facilitate sustained behavior change at delayed follow-up. Additional research is necessary to replicate findings in a larger sample and to determine the mediators of emotional education intervention efficacy.

Can gossip change nutrition behaviour? Results of a mass media and community-based intervention trial in East Java, Indonesia.

PubMed

White, Sian; Schmidt, Wolf; Sahanggamu, Daniel; Fatmaningrum, Dewi; van Liere, Marti; Curtis, Val

2016-03-01

It is unclear how best to go about improving child feeding practices. We studied the effect of a novel behaviour change intervention, Gerakan Rumpi Sehat (the Healthy Gossip Movement), on infant and young child feeding practices in peri-urban Indonesia. The pilot intervention was designed based on the principles of a new behaviour change theory, Behaviour Centred Design (BCD). It avoided educational messaging in favour of employing emotional drivers of behaviour change, such as affiliation, nurture and disgust and used television commercials, community activations and house-to-house visits as delivery channels. The evaluation took the form of a 2-arm cluster randomised trial with a non-randomised control arm. One intervention arm received TV only, while the other received TV plus community activations. The intervention components were delivered over a 3-month period in 12 villages in each arm, each containing an average of 1300 households. There were two primary outcomes: dietary diversity of complementary food and the provision of unhealthy snacks to children aged 6-24 months. Dietary diversity scores increased by 0.8 points in the arm exposed to TV adverts only (95% CI: 0.4-1.2) and a further 0.2 points in the arm that received both intervention components (95% CI: 0.6-1.4). In both intervention arms, there were increases in the frequency of vegetable and fruit intake. We found inconsistent evidence of an effect on unhealthy snacking. The study suggests that novel theory-driven approaches which employ emotional motivators are capable of having an effect on improving dietary diversity and the regularity of vegetable and fruit intake among children aged 6-24 months. Mass media can have a measurable effect on nutrition-related behaviour, but these effects are likely to be enhanced through complementary community activations. Changing several behaviours at once remains a challenge. © 2016 The Authors. Tropical Medicine & International Health Published by John Wiley & Sons Ltd.

A Validated Task Analysis of the Single Pilot Operations Concept

NASA Technical Reports Server (NTRS)

Wolter, Cynthia A.; Gore, Brian F.

2015-01-01

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

A psychosocial intervention for the management of functional dysphonia: complex intervention development and pilot randomised trial.

PubMed

Deary, Vincent; McColl, Elaine; Carding, Paul; Miller, Tracy; Wilson, Janet

2018-01-01

Medically unexplained loss or alteration of voice-functional dysphonia-is the commonest presentation to speech and language therapists (SLTs). Besides the impact on personal and work life, functional dysphonia is also associated with increased levels of anxiety and depression and poor general health. Voice therapy delivered by SLTs improves voice but not these associated symptoms. The aims of this research were the systematic development of a complex intervention to improve the treatment of functional dysphonia, and the trialling of this intervention for feasibility and acceptability to SLTs and patients in a randomised pilot study. A theoretical model of medically unexplained symptoms (MUS) was elaborated through literature review and synthesis. This was initially applied as an assessment format in a series of patient interviews. Data from this stage and a small consecutive cohort study were used to design and refine a brief cognitive behavioural therapy (CBT) training intervention for a SLT. This was then implemented in an external pilot patient randomised trial where one SLT delivered standard voice therapy or voice therapy plus CBT to 74 patients. The primary outcomes were of the acceptability of the intervention to patients and the SLT, and the feasibility of changing the SLT's clinical practice through a brief training. This was measured through monitoring treatment flow and through structured analysis of the content of intervention for treatment fidelity and inter-treatment contamination. As measured by treatment flow, the intervention was as acceptable as standard voice therapy to patients. Analysis of treatment content showed that the SLT was able to conduct a complex CBT formulation and deliver novel treatment strategies for fatigue, sleep, anxiety and depression in the majority of patients. On pre-post measures of voice and quality of life, patients in both treatment arms improved. These interventions were acceptable to patients. Emotional and psychosocial issues presented routinely in the study patient group and CBT techniques were used, deliberately and inadvertently, in both treatment arms. This CBT "contamination" of the voice therapy only arm reflects the chief limitation of the study: one therapist delivered both treatments. Registered with the ISRCTN under the title: Training a Speech and Language Therapist in Cognitive Behavioural Therapy to treat Functional Dysphonia - A Randomised Controlled Trial .Trial Identifier: ISRCTN20582523 Registered 19/05/2010; retrospectively registered. http://www.isrctn.com/ISRCTN20582523.

Integrated optical XY coupler

DOEpatents

Vawter, G. Allen; Hadley, G. Ronald

1997-01-01

An integrated optical XY coupler having two converging input waveguide arms meeting in a central section and a central output waveguide arm and two diverging flanking output waveguide arms emanating from the central section. In-phase light from the input arms constructively interfers in the central section to produce a single mode output in the central output arm with the rest of the light being collected in the flanking output arms. Crosstalk between devices on a substrate is minimized by this collection of the out-of-phase light by the flanking output arms of the XY coupler.

Integrated optical XY coupler

DOEpatents

Vawter, G.A.; Hadley, G.R.

1997-05-06

An integrated optical XY coupler having two converging input waveguide arms meeting in a central section and a central output waveguide arm and two diverging flanking output waveguide arms emanating from the central section. In-phase light from the input arms constructively interferes in the central section to produce a single mode output in the central output arm with the rest of the light being collected in the flanking output arms. Crosstalk between devices on a substrate is minimized by this collection of the out-of-phase light by the flanking output arms of the XY coupler. 9 figs.

Bimonthly 24 h infusion of high-dose 5-fluorouracil vs EAP regimen in patients with advanced gastric cancer. A randomized phase II study.

PubMed

Popov, I P; Jelić, S B; Krivokapić, Z V; Jezdić, S D; Pesko, P M; Micev, M T; Babić, D R

2008-01-01

To investigate the activity and toxicity of high dose (HD) infusional 5-FU in comparison to EAP regimen as first-line chemotherapy in patients with advanced gastric cancer. Histologically confirmed measurable advanced gastric cancer, age < 72 yr, ECOG performance status 0-2, no prior chemo- and radiotherapy, adequate organ functions. EAP arm: doxorubicin (40 mg/m(2)), etoposide (360 mg/m(2)), and cisplatin (80 mg/m(2)) every 28 d; HD 5-FU arm: 5-FU 2.6 g/m(2) 24 h infusion, biweekly. Sixty patients were randomized. Patient characteristics (arms EAP/HD 5-FU): Median age 57/55 yr, median PS 1/1, LAD (patients) 3/8, M1 (patients) 27/22. Median number of cycles (range): EAP arm 4 (2-8), HD 5-FU arm 2 (1-8). Worst toxicity per cycle (grade 3 and 4 in%): Neutropenia 20/3, thrombocytopenia 9/0, anemia 9/13, diarrhea 3/10, nausea 17/7, vomiting 10/0 for EAP and HD 5-FU arms, respectively. All patients were eligible for response in both arms. Confirmed response rate (95%CI): EAP arm 34% [16-50%]/HD 5-FU arm 10% (0-21%), no change: 46/40%, progression of disease: 20/50, respectively. Overall survival (range): EAP arm A 7 mo [3-27], HD 5-FU arm 6 mo (4-25). Infusional HD 5-FU showed a low incidence of severe toxicity. But given the low efficacy of 5-FU in the dosage we applied in the study, it cannot be recommended as a single treatment for further studies. Assessment of higher dose intensity and/or dose density of 5-FU, with introduction of other active drugs in combination, could be an option for further studies.

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

ERIC Educational Resources Information Center

Rizvi, Shireen L.; Linehan, Marsha M.

2005-01-01

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

Tai Chi for People with Visual Impairments: A Pilot Study

ERIC Educational Resources Information Center

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

2004-01-01

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

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

ERIC Educational Resources Information Center

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

2013-01-01

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

Single Pilot Workload Management During Cruise in Entry Level Jets

NASA Technical Reports Server (NTRS)

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

2013-01-01

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

High resolution neutron Larmor diffraction using superconducting magnetic Wollaston prisms

DOE PAGES

Li, Fankang; Feng, Hao; Thaler, Alexander N.; ...

2017-04-13

The neutron Larmor diffraction technique has been implemented using superconducting magnetic Wollaston prisms in both single-arm and double-arm configurations. Successful measurements of the coefficient of thermal expansion of a single-crystal copper sample demonstrates that the method works as expected. Our experiment involves a new method of tuning by varying the magnetic field configurations in the device and the tuning results agree well with previous measurements. The difference between single-arm and double-arm configurations has been investigated experimentally. Here, we conclude that this measurement benchmarks the applications of magnetic Wollaston prisms in Larmor diffraction and shows in principle that the setup canmore » be used for inelastic phonon line-width measurements. The achievable resolution for Larmor diffraction is comparable to that using Neutron Resonance Spin Echo (NRSE) coils. Furthermore, the use of superconducting materials in the prisms allows high neutron polarization and transmission efficiency to be achieved.« less

Accounting for uncertainty in the historical response rate of the standard treatment in single-arm two-stage designs based on Bayesian power functions.

PubMed

Matano, Francesca; Sambucini, Valeria

2016-11-01

In phase II single-arm studies, the response rate of the experimental treatment is typically compared with a fixed target value that should ideally represent the true response rate for the standard of care therapy. Generally, this target value is estimated through previous data, but the inherent variability in the historical response rate is not taken into account. In this paper, we present a Bayesian procedure to construct single-arm two-stage designs that allows to incorporate uncertainty in the response rate of the standard treatment. In both stages, the sample size determination criterion is based on the concepts of conditional and predictive Bayesian power functions. Different kinds of prior distributions, which play different roles in the designs, are introduced, and some guidelines for their elicitation are described. Finally, some numerical results about the performance of the designs are provided and a real data example is illustrated. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Second-line single-agent versus doublet chemotherapy as salvage therapy for metastatic urothelial cancer: a systematic review and meta-analysis.

PubMed

Raggi, D; Miceli, R; Sonpavde, G; Giannatempo, P; Mariani, L; Galsky, M D; Bellmunt, J; Necchi, A

2016-01-01

The efficacy and safety of a combination of chemotherapeutic agent compared with single-agent chemotherapy in the second-line setting of advanced urothelial carcinoma (UC) are unclear. We aimed to study the survival impact of single-agent compared with doublet chemotherapy as second-line chemotherapy of advanced UC. Literature was searched for studies including single-agent or doublet chemotherapy in the second-line setting after platinum-based chemotherapy. Random-effects models were used to pool trial-level data according to treatment arm, including median progression-free survival (PFS), overall survival (OS), objective response rate (ORR) probability, and grade 3-4 toxicity. Univariable and multivariable analyses, including sensitivity analyses, were carried out, adjusting for the percent of patients with ECOG performance status ≥1 and hepatic metastases. Forty-six arms of trials including 1910 patients were selected: 22 arms with single agent (n = 1202) and 24 arms with doublets (n = 708). The pooled ORR with single agents was 14.2% [95% confidence interval (CI) 11.1-17.9] versus 31.9% [95% CI 27.3-36.9] with doublet chemotherapy. Pooled median PFS was 2.69 and 4.05 months, respectively. The pooled median OS was 6.98 and 8.50 months, respectively. Multivariably, the odds ratio for ORR and the pooled median difference of PFS were statistically significant (P < 0.001 and P = 0.002) whereas the median difference in OS was not (P = 0.284). When including single-agent vinflunine or taxanes only, differences were significant only for ORR (P < 0.001) favoring doublet chemotherapy. No statistically significant differences in grade 3-4 toxicity were seen between the two groups. Despite significant improvements in ORR and PFS, doublet regimens did not extend OS compared with single agents for the second-line chemotherapy of UC. Prospective trials are necessary to elucidate the role of combination chemotherapy, with or without targeted agents, in the salvage setting. Currently, improvements in this field should be pursued considering single-agent chemotherapy as the foundation for new more active combinations. © The Author 2015. 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.

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

PubMed Central

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

2017-01-01

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

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

PubMed

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

2017-06-01

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

78 FR 63848 - Special Conditions: Embraer S.A., Model EMB-550 Airplanes; Sidestick Controllers

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-25

..., freedom of arm movement, controller displacement, handgrip size and accommodations for a range of pilot... column controls. Pitch and roll control force and displacement sensitivity must be compatible so that... precision path control/tasks and turbulence. In addition, pitch and roll control force and displacement...

The feasibility and acceptability of a chaplain-led intervention for caregivers of seriously ill patients: A Caregiver Outlook pilot study.

PubMed

Steinhauser, Karen E; Olsen, Annette; Johnson, Kimberly S; Sanders, Linda L; Olsen, Maren; Ammarell, Natalie; Grossoehme, Daniel

2016-10-01

When caring for a loved one with a life-limiting illness, a caregiver's own physical, emotional, and spiritual suffering can be profound. While many interventions focus on physical and emotional well-being, few caregiver interventions address existential and spiritual needs and the meaning that caregivers ascribe to their role. To evaluate the feasibility and acceptability of the process and content of Caregiver Outlook, we employed a manualized chaplain-led intervention to improve well-being by exploring role-related meaning among caregivers of patients with a life-limiting illness. We conducted a single-arm pre-post pilot evaluation among caregivers of patients with advanced cancer or amyotrophic lateral sclerosis (ALS). Caregivers completed three chaplain-led intervention sessions focusing on (1) a relationship review, (2) forgiveness, and (3) legacy. Outcomes administered at baseline and at 1 and 2 weeks after the intervention included quality of life, anxiety, depression, spiritual well-being, religious coping, caregiver burden, and grief. The sample (N = 31) included a range of socioeconomic status groups, and the average age was approximately 60 years. A third of them worked full-time. Some 74% of our participants cared for a spouse or partner, and the other quarter of the sample cared for a parent (13%), child (10%), or other close family member (3%). At baseline, participants did not demonstrate clinical threshold levels of anxiety, depression, or other indicators of distress. Outcomes were stable over time. The qualitative results showed the ways in which Caregiver Outlook was assistive: stepping back from day-to-day tasks, the opportunity to process emotions, reflecting on support received, provoking thoughts and emotions between sessions, discussing role changes, stimulating communication with others, and the anonymity of a phone conversation. Both religious and nonreligious participants were pleased with administration of the chaplain intervention. The acceptability and feasibility of Caregiver Outlook were demonstrated among caregivers of patients with an advanced illness. Our pilot findings suggest minor modifications to study participant screening, interventionist guidance, and the study measures.

A pilot randomized study comparing extralevator with conventional abdominoperineal excision for low rectal cancer after neoadjuvant chemoradiation.

PubMed

Seshadri, R A; West, N P; Sundersingh, S

2017-07-01

The aims of this study were to assess the feasibility of performing an extralevator abdominoperineal excision (ELAPE) after neoadjuvant chemoradiation (NCRT), to compare the rates of circumferential resection margin (CRM) involvement and intra-operative perforation (IOP) of the specimen, and to assess the amount of tissue removed around the muscularis propria (MP)/internal sphincter (IS) of the lower rectum in patients with low rectal cancer undergoing ELAPE compared with conventional abdominoperineal excision (CAPE) after NCRT. This was an open-label, parallel-arm pilot randomized trial conducted in India. Twenty patients were randomized to one of the study arms. The surgical specimens were fixed, serially cross-sectioned and photographed. Using specialized morphometry software, the amount of tissue resected with each operation was measured. There was a nonsignificant trend towards more IOPs (30% vs 0%, P = 0.06) and a higher CRM involvement rate (40% vs 20%, P = 0.32) in the CAPE arm. ELAPE removed a significantly greater amount of tissue around the IS/MP when compared with CAPE (mean ± SD: 1911.39 ± 382 mm 2 vs 1132.03 ± 371 mm 2 , P < 0.001). The mean distance from the IS/MP to the CRM was significantly greater in the ELAPE arm both in the posterior (mean ± SD: 28.28 ± 3 mm vs 9.63 ± 3 mm, P < 0.001) and lateral (mean ± SD: 13.69 ± 3 mm vs 9.72 ± 3 mm, P = 0.009) parts of the rectum but not in the anterior part (mean ± SD: 6.74 ± 2 mm vs 6.10 ± 4 mm, P = 0.64). The short-term morbidity was not significantly different between the two procedures. ELAPE removed more tissue in the lower rectum and resulted in a lower rate of IOP and CRM involvement when compared with CAPE, even after NCRT. Colorectal Disease © 2017 The Association of Coloproctology of Great Britain and Ireland.

The impact of tailored text messages on health beliefs and medication adherence in adults with diabetes: A randomized pilot study.

PubMed

Gatwood, Justin; Balkrishnan, Rajesh; Erickson, Steven R; An, Lawrence C; Piette, John D; Farris, Karen B

2016-01-01

Inadequate medication adherence reduces optimal health outcomes and can lead to increased costs, particularly in patients with diabetes. Efforts to improve adherence have resulted in limited effects; approaches leveraging mobile technology have emerged, but their focus has mainly been limited to simple reminder messages. The purpose of this pilot study was to test the effectiveness of tailored text messages focusing on improving medication adherence and health beliefs in adults with diabetes. Adults aged 21-64, with uncontrolled diabetes, and taking at least one anti-diabetic medication were recruited and randomized into 2 study arms: daily tailored text messaging for 90 days or standard care. Comparing baseline and endpoint survey responses, changes in theory-driven health beliefs and attitudes were assessed. The impact on medication adherence was evaluated using pharmacy claims by calculating the percent of days covered (PDC). A total of 75 subjects were consented, and 48 were randomized. Mean PDC at baseline were comparable between cohorts (84.4% and 87.1%, respectively). Declines in adherence were observed in both groups over time but no significant differences were observed between groups or from baseline to the end of the active study period. Unadjusted tests suggested that perceived benefits and competence might have improved in the intervention arm. Tailoring mobile phone text messages is a novel way to address medication nonadherence and health beliefs; further investigation to this combined technique is needed to better understand its impact on behavior change in adults with diabetes. Copyright © 2016 Elsevier Inc. All rights reserved.

Patient-specific rehearsal prior to EVAR: a pilot study.

PubMed

Desender, L; Rancic, Z; Aggarwal, R; Duchateau, J; Glenck, M; Lachat, M; Vermassen, F; Van Herzeele, I

2013-06-01

This study aims to evaluate feasibility, face validity, influence on technical factors and subjective sense of utility of patient-specific rehearsal (PsR) prior to endovascular aortic aneurysm repair (EVAR). A prospective, multicentre pilot study. Patients suitable for EVAR were enrolled and a three-dimensional (3D) model of the patient's anatomy was generated. Less than 24 h prior to the real case, rehearsals were conducted in the laboratory or clinical angiosuite. Technical metrics were recorded during both procedures. A subjective questionnaire was used to evaluate realism, technical and human factor aspects (scale 1-5). Ten patients were enrolled. In one case, the treatment plan was altered based on PsR. In 7/9 patients, the rehearsal significantly altered the optimal C-arm position for the proximal landing zone and an identical fluoroscopy angle was chosen in the real procedure. All team members found the rehearsal useful for selecting the optimal fluoroscopy angle (median 4). The realism of the EVAR procedure simulation was rated highly (median 4). All team members found the PsR useful to prepare the individual team members and the entire team (median 4). PsR for EVAR permits creation of realistic case studies. Subjective evaluation indicates that it may influence optimal C-arm angles and be valuable to prepare the entire team. A randomised controlled trial (RCT) is planned to evaluate how this technology may influence technical and team performance, ultimately leading to improved patient safety. Copyright © 2013 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Single-arm trial of the second version of an acceptance & commitment therapy smartphone application for smoking cessation.

PubMed

Bricker, Jonathan B; Copeland, Wade; Mull, Kristin E; Zeng, Emily Y; Watson, Noreen L; Akioka, Katrina J; Heffner, Jaimee L

2017-01-01

The first randomized trial of a smartphone application (app) for adult smoking cessation (SmartQuit 1.0) revealed key features that predict cessation. These findings guided the revision of this Acceptance & Commitment Therapy (ACT)-based application (SmartQuit 2.0), which was primarily tested to examine participant receptivity, short-term cessation and reduction, and the relationship between program completion, smoking cessation and reduction. Secondarily, outcomes were descriptively compared with the SmartQuit1.0 trial. Adult participants (78% female, 25% with high school or less education, 30% unemployed) were recruited into the single-arm pilot trial (N=99) of SmartQuit 2.0 with a two-month follow-up (85% retention). Regarding receptivity, 84% of participants were satisfied with SmartQuit 2.0 (vs. 59% for SmartQuit1.0), 73% would recommend it to a friend (vs. 48% for SmartQuit1.0), 81% found the ACT exercises useful for quitting (vs. 44% for SmartQuit1.0). At the 2-month follow-up, the quit rates were 21% for 7-day point prevalence (vs. 23% for SmartQuit1.0), 11% for 30-day point prevalence (vs. 13% for SmartQuit1.0), and 75% of participants reduced their smoking frequency (vs. 57% for SmartQuit1.0). Among program completers (24% of total sample), the quit rates were 33% for 7-day point prevalence, 28% for 30-day point prevalence, and 88% of participants reduced their smoking frequency. The revised app had high user receptivity, modest quit rates, and high smoking reduction rates. Program completion may be key to boosting the app's effectiveness. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Development of a 3D immersive videogame to improve arm-postural coordination in patients with TBI

PubMed Central

2011-01-01

Background Traumatic brain injury (TBI) disrupts the central and executive mechanisms of arm(s) and postural (trunk and legs) coordination. To address these issues, we developed a 3D immersive videogame-- Octopus. The game was developed using the basic principles of videogame design and previous experience of using videogames for rehabilitation of patients with acquired brain injuries. Unlike many other custom-designed virtual environments, Octopus included an actual gaming component with a system of multiple rewards, making the game challenging, competitive, motivating and fun. Effect of a short-term practice with the Octopus game on arm-postural coordination in patients with TBI was tested. Methods The game was developed using WorldViz Vizard software, integrated with the Qualysis system for motion analysis. Avatars of the participant's hands precisely reproducing the real-time kinematic patterns were synchronized with the simulated environment, presented in the first person 3D view on an 82-inch DLP screen. 13 individuals with mild-to-moderate manifestations of TBI participated in the study. While standing in front of the screen, the participants interacted with a computer-generated environment by popping bubbles blown by the Octopus. The bubbles followed a specific trajectory. Interception of the bubbles with the left or right hand avatar allowed flexible use of the postural segments for balance maintenance and arm transport. All participants practiced ten 90-s gaming trials during a single session, followed by a retention test. Arm-postural coordination was analysed using principal component analysis. Results As a result of the short-term practice, the participants improved in game performance, arm movement time, and precision. Improvements were achieved mostly by adapting efficient arm-postural coordination strategies. Of the 13 participants, 10 showed an immediate increase in arm forward reach and single-leg stance time. Conclusion These results support the feasibility of using the custom-made 3D game for retraining of arm-postural coordination disrupted as a result of TBI. PMID:22040301

Development of a 3D immersive videogame to improve arm-postural coordination in patients with TBI.

PubMed

Ustinova, Ksenia I; Leonard, Wesley A; Cassavaugh, Nicholas D; Ingersoll, Christopher D

2011-10-31

Traumatic brain injury (TBI) disrupts the central and executive mechanisms of arm(s) and postural (trunk and legs) coordination. To address these issues, we developed a 3D immersive videogame--Octopus. The game was developed using the basic principles of videogame design and previous experience of using videogames for rehabilitation of patients with acquired brain injuries. Unlike many other custom-designed virtual environments, Octopus included an actual gaming component with a system of multiple rewards, making the game challenging, competitive, motivating and fun. Effect of a short-term practice with the Octopus game on arm-postural coordination in patients with TBI was tested. The game was developed using WorldViz Vizard software, integrated with the Qualysis system for motion analysis. Avatars of the participant's hands precisely reproducing the real-time kinematic patterns were synchronized with the simulated environment, presented in the first person 3D view on an 82-inch DLP screen. 13 individuals with mild-to-moderate manifestations of TBI participated in the study. While standing in front of the screen, the participants interacted with a computer-generated environment by popping bubbles blown by the Octopus. The bubbles followed a specific trajectory. Interception of the bubbles with the left or right hand avatar allowed flexible use of the postural segments for balance maintenance and arm transport. All participants practiced ten 90-s gaming trials during a single session, followed by a retention test. Arm-postural coordination was analysed using principal component analysis. As a result of the short-term practice, the participants improved in game performance, arm movement time, and precision. Improvements were achieved mostly by adapting efficient arm-postural coordination strategies. Of the 13 participants, 10 showed an immediate increase in arm forward reach and single-leg stance time. These results support the feasibility of using the custom-made 3D game for retraining of arm-postural coordination disrupted as a result of TBI.

Differences in physical workload between military helicopter pilots and cabin crew.

PubMed

Van den Oord, Marieke H A; Sluiter, Judith K; Frings-Dresen, Monique H W

2014-05-01

The 1-year prevalence of regular or continuous neck pain in military helicopter pilots of the Dutch Defense Helicopter Command (DHC) is 20%, and physical work exposures have been suggested as risk factors. Pilots and cabin crew perform different tasks when flying helicopters. The aims of the current study were to compare the exposures to physical work factors between these occupations and to estimate the 1-year prevalence of neck pain in military helicopter cabin crew members. A survey was completed by almost all available helicopter pilots (n = 113) and cabin crew members (n = 61) of the DHC. The outcome measures were self-reported neck pain and exposures to nine physical work factors. Differences in the proportions of helicopter pilots and cabin crew members reporting being often exposed to the particular physical factor were assessed with the χ(2) test. The 1-year prevalence of regular or continuous neck pain among cabin crew was 28%. Significantly more cabin crew members than pilots reported being often exposed to manual material handling, performing dynamic movements with their torsos, working in prolonged bent or twisted postures with their torsos and their necks, working with their arms raised and working in awkward postures. Often exposure to prolonged sitting and dynamic movements with the neck were equally reported by almost all the pilots and cabin crew members. Flight-related neck pain is prevalent in both military helicopter pilots and cabin crew members. The exposures to neck pain-related physical work factors differ between occupations, with the cabin crew members subjected to more factors. These results have implications for preventative strategies for flight-related neck pain.

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

PubMed

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

2005-01-01

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

Weight loss reduces breast ductal fluid estrogens in obese postmenopausal women: a single arm intervention pilot study.

PubMed

Carpenter, Catherine L; Duvall, Karen; Jardack, Patricia; Li, Luyi; Henning, Susanne M; Li, Zhaoping; Heber, David

2012-12-05

Accumulation of excess body fat increases breast cancer risk after menopause. Whether the localized breast is differently influenced by adipose tissue compared to the rest of the body, has not been well studied. Our purpose was to demonstrate feasibility and preliminarily evaluate serum-based and localized breast biomarker changes resulting from a weight loss intervention among obese postmenopausal women. We conducted a 12-week pilot controlled dietary and exercise intervention among healthy obese postmenopausal women, collected serum and breast ductal fluid before and after the intervention, and estimated the association with systemic and localized biomarker changes. We recruited 7 obese (mean body mass index = 33.6 kg/m2) postmenopausal women. We collected samples at baseline and the 12th week for: anthropometry; phlebotomy; dual-energy x-ray absorptiometry (lean and fat mass); exercise fitness (maximum oxygen consumption (VO2Max); 1-repetition strength maximum); and breast ductal lavage. Changes from baseline occurred in body composition and exercise performance including fat mass loss (14% average drop), VO2Max (+36% increase) and strength improvement (+26%). Breast ductal fluid markers declined from baseline with estradiol showing a 24% reduction and IL-6 a 20% reduction. We also observed serum biomarker reductions from baseline including leptin (36% decline), estrone sulfate (-10%), estradiol (-25%), and Il-6 (-33%). Conduct of the diet and exercise intervention, collection of ductal fluid, and measurement of hormones and cytokines contained in the ductal fluid were all feasible. We preliminarily demonstrated estradiol and IL-6 reductions from baseline in both serum and breast ductal fluid among obese postmenopausal women who participated in the 12-week weight loss diet and exercise intervention.

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

PubMed Central

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

2017-01-01

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

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

PubMed

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

2017-04-01

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

C1 Inhibitor in Acute Antibody-Mediated Rejection Nonresponsive to Conventional Therapy in Kidney Transplant Recipients: A Pilot Study.

PubMed

Viglietti, D; Gosset, C; Loupy, A; Deville, L; Verine, J; Zeevi, A; Glotz, D; Lefaucheur, C

2016-05-01

Complement inhibitors have not been thoroughly evaluated in the treatment of acute antibody-mediated rejection (ABMR). We performed a prospective, single-arm pilot study to investigate the potential effects and safety of C1 inhibitor (C1-INH) Berinert added to high-dose intravenous immunoglobulin (IVIG) for the treatment of acute ABMR that is nonresponsive to conventional therapy. Kidney recipients with nonresponsive active ABMR and acute allograft dysfunction were enrolled between April 2013 and July 2014 and received C1-INH and IVIG for 6 months (six patients). The primary end point was the change in eGFR at 6 months after inclusion (M+6). Secondary end points included the changes in histology and DSA characteristics and adverse events as evaluated at M+6. All patients showed an improvement in eGFR between inclusion and M+6: from 38.7 ± 17.9 to 45.2 ± 21.3 mL/min/1.73 m(2) (p = 0.0277). There was no change in histological features, except a decrease in the C4d deposition rate from 5/6 to 1/6 (p = 0.0455). There was a change in DSA C1q status from 6/6 to 1/6 positive (p = 0.0253). One deep venous thrombosis was observed. In a secondary analysis, C1-INH patients were compared with a similar historical control group (21 patients). C1-INH added to IVIG is safe and may improve allograft function in kidney recipients with nonresponsive acute ABMR. © Copyright 2015 The American Society of Transplantation and the American Society of Transplant Surgeons.

Phase shift in atom interferometry due to spacetime curvature

NASA Astrophysics Data System (ADS)

Overstreet, Chris; Asenbaum, Peter; Kovachy, Tim; Brown, Daniel; Hogan, Jason; Kasevich, Mark

2017-04-01

In previous matter wave interferometers, the interferometer arm separation was small enough that gravitational tidal forces across the arms can be neglected. Gravitationally-induced phase shifts in such experiments arise from the acceleration of the interfering particles with respect to the interferometer beam splitters and mirrors. By increasing the interferometer arm separation, we enter a new regime in which the arms experience resolvably different gravitational forces. Using a single-source gravity gradiometer, we measure a phase shift associated with the tidal forces induced by a nearby test mass. This is the first observation of spacetime curvature across the spatial extent of a single quantum system. CO acknowledges funding from the Stanford Graduate Fellowship.

Effect of multi-adhesive layering on retention of extraoral maxillofacial silicone prostheses in vivo.

PubMed

Kiat-Amnuay, Sudarat; Gettleman, Lawrence; Goldsmith, L Jane

2004-09-01

Loss of retention of maxillofacial prostheses often makes the margin visible or the prosthesis dislodge. Using several medical adhesives in combination may improve retention. The purpose of this study was to investigate the effect of single- and multi-adhesive layering of 2 adhesives on the retention of maxillofacial silicone elastomer strips adhered to the skin of human forearms using a peel test. Power analysis from a previous study and a pilot trial specified at least 20 subjects. Eight Silastic Adhesive A/MDX4-4210 silicone rubber strips (N=240) were applied in a predetermined random order to the left and right ventral forearms of 30 IRB-approved human subjects. Skin-Prep Protective Dressing was applied. Secure 2 Medical Adhesive (SMA) and Epithane-3 (E3) adhesive were used alone or as SMA/E3 or E3/SMA sandwiches (from skin to prosthesis) to adhere strips. Strips were peeled 6 hours later in a universal testing machine at 10 cm/min and data reported in N/m. Paired t tests were used to evaluate left and right arm differences. A Friedman test for nonparametric correlated data with within-subject design was performed, determining differences between both adhesives singly and in combination (alpha=.05). Tests of left-right differences were insignificant ( P =0.43), so the data from both arms were combined. Many strips with E3 did not adhere before testing and were counted as 0 adhesion. Median peel strengths (and 25th and 75th percentiles) in N/m were: SMA = 76.1 (47.1-107), E3 = 6.75 (0.0-25.9), SMA/E3 = 107 (78.0-132), and E3/SMA= 19.6 (6.99-42.4). All 4 variables were significantly different ( P <.0005). The multi-adhesive combination of SMA/E3 had the highest adhesion, followed, in order, by SMA alone, E3/ SMA, and E3 alone. Both E3 groups left a difficult-to-remove residue on the skin. SMA/E3 left a halo-like residue on the skin at the periphery of the strips from the E3 leaking around the SMA. SMA remained adherent to the prosthetic material.

Prospective single-arm interventional pilot study to assess a smartphone-based system for measuring and supporting adherence to medication.

PubMed

Molton, James S; Pang, Yan; Wang, Zhuochun; Qiu, Boqin; Wu, Pei; Rahman-Shepherd, Afifah; Ooi, Wei Tsang; Paton, Nicholas I

2016-12-20

Suboptimal medication adherence for infectious diseases such as tuberculosis (TB) results in poor clinical outcomes and ongoing infectivity. Directly observed therapy (DOT) is now standard of care for TB treatment monitoring but has a number of limitations. We aimed to develop and evaluate a smartphone-based system to facilitate remotely observed therapy via transmission of videos rather than in-person observation. We developed an integrated smartphone and web-based system (Mobile Interactive Supervised Therapy, MIST) to provide regular medication reminders and facilitate video recording of pill ingestion at predetermined timings each day, for upload and later review by a healthcare worker. We evaluated the system in a single arm, prospective study of adherence to a dietary supplement. Healthy volunteers were recruited through an online portal. Entry criteria included age ≥21 and owning an iOS or Android-based device. Participants took a dietary supplement pill once, twice or three-times a day for 2 months. We instructed them to video each pill taking episode using the system. Adherence as measured by the smartphone system and by pill count. 42 eligible participants were recruited (median age 24; 86% students). Videos were classified as received-confirmed pill intake (3475, 82.7% of the 4200 videos expected), received-uncertain pill intake (16, <1%), received-fake pill intake (31, <1%), not received-technical issues (223, 5.3%) or not received-assumed non-adherence (455, 10.8%). Overall median estimated participant adherence by MIST was 90.0%, similar to that obtained by pill count (93.8%). There was a good relationship between participant adherence as measured by MIST and by pill count (Spearmans r s 0.66, p<0.001). We have demonstrated the feasibility, acceptability and accuracy of a smartphone-based adherence support and monitoring system. The system has the potential to supplement and support the provision of DOT for TB and also to improve adherence in other conditions such as HIV and hepatitis C. 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/.

Daily text messaging for weight control among racial and ethnic minority women: randomized controlled pilot study.

PubMed

Steinberg, Dori M; Levine, Erica L; Askew, Sandy; Foley, Perry; Bennett, Gary G

2013-11-18

Daily self-monitoring of diet and physical activity behaviors is a strong predictor of weight loss success. Text messaging holds promise as a viable self-monitoring modality, particularly among racial/ethnic minority populations. This pilot study evaluated the feasibility of a text messaging intervention for weight loss among predominantly black women. Fifty obese women were randomized to either a 6-month intervention using a fully automated system that included daily text messages for self-monitoring tailored behavioral goals (eg, 10,000 steps per day, no sugary drinks) along with brief feedback and tips (n=26) or to an education control arm (n=24). Weight was objectively measured at baseline and at 6 months. Adherence was defined as the proportion of text messages received in response to self-monitoring prompts. The average daily text messaging adherence rate was 49% (SD 27.9) with 85% (22/26) texting self-monitored behavioral goals 2 or more days per week. Approximately 70% (16/23) strongly agreed that daily texting was easy and helpful and 76% (16/21) felt the frequency of texting was appropriate. At 6 months, the intervention arm lost a mean of 1.27 kg (SD 6.51), and the control arm gained a mean of 1.14 kg (SD 2.53; mean difference -2.41 kg, 95% CI -5.22 to 0.39; P=.09). There was a trend toward greater text messaging adherence being associated with greater percent weight loss (r=-.36; P=.08), but this did not reach statistical significance. There was no significant association between goal attainment and text messaging adherence and no significant predictors of adherence. Given the increasing penetration of mobile devices, text messaging may be a useful self-monitoring tool for weight control, particularly among populations most in need of intervention. Clinicaltrials.gov: NCT00939081; http://clinicaltrials.gov/show/NCT00939081 (Archived by WebCite at http://www.webcitation.org/6KiIIcnk1).

A phase II study of lapatinib in recurrent/metastatic squamous cell carcinoma of the head and neck.

PubMed

de Souza, Jonas A; Davis, Darren W; Zhang, Yujian; Khattri, Arun; Seiwert, Tanguy Y; Aktolga, Serdal; Wong, Stuart J; Kozloff, Mark F; Nattam, Sreenivasa; Lingen, Mark W; Kunnavakkam, Rangesh; Stenson, Kerstin M; Blair, Elizabeth A; Bozeman, Jeffrey; Dancey, Janet E; Vokes, Everett E; Cohen, Ezra E W

2012-04-15

This study sought to determine the efficacy and safety profile of lapatinib in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN). This phase II multiinstitutional study enrolled patients with recurrent/metastatic SCCHN into two cohorts: those without (arm A) and those with (arm B) before exposure to an epidermal growth factor receptor (EGFR) inhibitor. All subjects were treated with lapatinib 1,500 mg daily. Primary endpoints were response rate (arm A) and progression-free survival (PFS; arm B). The biologic effects of lapatinib on tumor growth and survival pathways were assessed in paired tumor biopsies obtained before and after therapy. Forty-five patients were enrolled, 27 in arm A and 18 in arm B. Diarrhea was the most frequent toxicity occurring in 49% of patients. Seven patients experienced related grade 3 toxicity (3 fatigue, 2 hyponatremia, 1 vomiting, and 1 diarrhea). In an intent-to-treat analysis, no complete or partial responses were observed, and stable disease was the best response observed in 41% of arm A (median duration, 50 days, range, 34-159) and 17% of arm B subjects (median, 163 days, range, 135-195). Median PFS was 52 days in both arms. Median OS was 288 (95% CI, 62-374) and 155 (95% CI, 75-242) days for arms A and B, respectively. Correlative analyses revealed an absence of EGFR inhibition in tumor tissue. Lapatinib as a single agent in recurrent/metastatic SCCHN, although well tolerated, appears to be inactive in either EGFR inhibitor naive or refractory subjects. ©2012 AACR.

A pilot study of magnetic therapy for hot flashes after breast cancer.

PubMed

Carpenter, Janet S; Wells, Nancy; Lambert, Beth; Watson, Peggy; Slayton, Tami; Chak, Bapsi; Hepworth, Joseph T; Worthington, W Bradley

2002-04-01

The purpose of this randomized placebo-controlled crossover pilot study was to evaluate the effectiveness and acceptability of magnetic therapy for hot flashes among breast cancer survivors. Participants completed a 24-hour baseline hot-flash monitoring session, wore the magnetic devices or placebo for 3 days, completed an after-treatment hot-flash monitoring session, experienced a 10-day washout period, and then crossed over to the opposite study arm. Magnetic devices and placebos were placed on 6 acupressure sites corresponding to hot-flash relief. Complete data were available from 11 survivors of breast cancer. Results indicated magnetic therapy was no more effective than placebo in decreasing hot-flash severity, and contrary to expectations, placebo was significantly more effective than magnets in decreasing hot-flash frequency, bother, interference with daily activities, and overall quality of life. Implications for clinical practice and future research include the need to explore alternative interventions aimed at alleviating hot flashes in this population.

Deliberate self-harm in 15-year-old adolescents: a pilot study with a modified version of the Deliberate Self-Harm Inventory.

PubMed

Lundh, Lars-Gunnar; Karim, Jessica; Quilisch, Eva

2007-02-01

The purpose of the present study was to investigate the rate of deliberate self-harm in 15-year-old Swedish adolescents, gender differences in this behavior, and possible associations with self-esteem and mindfulness. For this purpose, we developed a simplified version of Gratz's (2001) Deliberate Self-Harm Inventory (DSHI), and carried out a pilot study with 123 adolescents from three different schools in southern Sweden. The results showed that 65.9% of the adolescents reported having engaged in some kind of deliberate self-harm at least once; 41.5% reported at least one kind of self-harm more than once; and 13.8% reported at least one kind of deliberate self-harm behavior "many times". Although there were no overall gender differences in self-harm, the girls reported significantly more of cutting wrists, arms and other body areas than the boys. High rates of deliberate self-harm were associated with low self-esteem and low mindfulness.

Area Handbook Series: Soviet Union: A Country Study

DTIC Science & Technology

1989-05-01

War, edited by Harriet F. Scott and William F. Scott, is a judicious combination of the editors’ commentaries and of excerpts from translated writ...equipped the Soviet armed forces to capably fulfill their assigned missions. The single most complete work on the Soviet armed forces is Harriet F. Scott and...Hague: Martinus Nijhoff, 1969. _ _ Russian Intellectual History: An Anthology. New York: Hu- manities Press, 1978. Riasanovsky, Nicholas. A History of

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

ERIC Educational Resources Information Center

Tal-Atzili, Orit; Salls, Joyce

2017-01-01

This pilot study investigated the efficacy of Qigong Sensory Training, a parent-implemented tactile intervention, in improving sensory processing and self-regulation in children with or at-risk for autism who were enrolled in early intervention. A pretest-posttest, single-subject design was implemented with three families. After 5 months, atypical…

Oxytocin effects on emotional response to others' faces via serotonin system in autism: A pilot study.

PubMed

Fukai, Mina; Hirosawa, Tetsu; Kikuchi, Mitsuru; Ouchi, Yasuomi; Takahashi, Tetsuya; Yoshimura, Yuko; Miyagishi, Yoshiaki; Kosaka, Hirotaka; Yokokura, Masamichi; Yoshikawa, Etsuji; Bunai, Tomoyasu; Minabe, Yoshio

2017-09-30

The oxytocin (OT)-related serotonergic system is thought to play an important role in the etiology and social symptoms of autism spectrum disorder (ASD). However, no evidence exists for the relation between the prosocial effect of chronic OT administration and the brain serotonergic system. Ten male subjects with ASD were administered OT for 8-10 weeks in an open-label, single-arm, non-randomized, uncontrolled manner. Before and during the OT treatment, positron emission tomography was used with the ( 11 C)-3-amino-4-(2-[(demethylamino)methyl]phenylthio)benzonitrile( 11 C-DASB) radiotracer. Then binding of serotonin transporter ( 11 C-DASB BP ND ) was estimated. The main outcome measures were changes in 11 C-DASB BP ND and changes in the emotional response to others' faces. No significant change was found in the emotional response to others' faces after the 8-10 week OT treatment. However, the increased serotonin transporter (SERT) level in the striatum after treatment was correlated significantly with increased negative emotional response to human faces. This study revealed a relation between changes in the serotonergic system and in prosociality after chronic OT administration. Additional studies must be conducted to verify the chronic OT effects on social behavior via the serotonergic system. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

Use of 99mTc-Tilmanocept as a Single Agent for Sentinel Lymph Node Identification in Breast Cancer: A Retrospective Pilot Study.

PubMed

Unkart, Jonathan T; Wallace, Anne M

2017-09-01

99m Tc-tilmanocept received recent Food and Drug Administration approval for lymphatic mapping in 2013. However, to our knowledge, no prior studies have evaluated the use of 99m Tc-tilmanocept as a single agent in sentinel lymph node (SLN) biopsy in breast cancer. Methods: We executed this retrospective pilot study to assess the ability of 99m Tc-tilmanocept to identify sentinel nodes as a single agent in clinically node-negative breast cancer patients. Patients received a single intradermal injection overlying the tumor of either 18.5 MBq (0.5 mCi) of 99m Tc-tilmanocept on the day of surgery or 74.0 MBq (2.0 mCi) on the day before surgery by a radiologist. Immediate 3-view lymphoscintigraphy was performed. Intraoperatively, SLNs were identified with a portable γ-probe. A node was classified as hot if the count (per second) of the node was more than 3 times the background count. Descriptive statistics are reported. Results: Nineteen patients underwent SLN biopsy with single-agent 99m Tc-tilmanocept. Immediate lymphoscintigraphy identified at least 1 sentinel node in 13 of 17 patients (76.5%). Intraoperatively, at least 1 (mean, 1.7 ± 0.8; range, 1-3) hot node was identified in all patients. Three patients (15.8%) had 1 disease-positive SLN. Conclusion: In this small, retrospective pilot study, 99m Tc-tilmanocept performed well as a single agent for intraoperative sentinel node identification in breast cancer. A larger, randomized clinical trial is warranted to compare 99m Tc-tilmanocept as a single agent with other radiopharmaceuticals for sentinel node identification in breast cancer. © 2017 by the Society of Nuclear Medicine and Molecular Imaging.

Reaching the unreached through trained and skilled birth attendants in Ethiopia: a cluster randomized controlled trial study protocol.

PubMed

Zerfu, Taddese Alemu; Taddese, Henok; Nigatu, Tariku; Tenkolu, Girma; Vogel, Joshua P; Khan-Neelofur, Dina; Biadgilign, Sibhatu; Deribew, Amare

2017-01-26

Despite improvements since 1990 to 2014, maternal mortality ratio (MMR) remains high in Ethiopia. One of the key drivers of maternal mortality in Ethiopia is the very low coverage of Skilled Birth attendance (SBA) in rural Ethiopia. This cluster randomized trial piloted an innovative approach of deploying trained community reproductive nurses (CORN) to hard to reach/unreachable rural Ethiopia to improve the coverage of SBA. We used a three-arm cluster randomized trial to test the effect of deploying CORN in rural communities in South Ethiopia to improve SBA and other maternal health indicators. A total of 282 villages/clusters (94 from each arm) were randomly selected in the three districts of the zone for the study. The intervention was implemented in four consecutive phases that aimed at of provision of essential maternal, neonatal and child health (MNCH) services mainly focusing on SBA. The CORN were trained and deployed in health centres (arm 1) and in the community/health posts (arm2). A third arm (arm 3) consisting control villages without the intervention. A baseline and end line assessment was conducted to compare the difference in the proportion of SBA and other MNCH service uptake across the three arms Data was entered into computer, edited, cleaned, and analyzed using Epi-data statistical software. The presentation followed the Consolidated Standards of Reporting Trials (CONSORT) statement guidelines for cluster-randomized trials. This trial is designed to test the impact of an innovative and newly designed means of distribution for the national health extension program strategy with additional service package with no change to the target population. The focus is on effect of CORN in revitalizing the Health Extension Program (HEP) through improving SBA service uptake and other maternal health service uptake indicators. The study findings may guide national policy to strengthen and shape the already existing HEP that has certain limitations to improve maternal health indicators. The competency based training methodology could provide feedback for health science colleges to improve the national nursing or midwifery training curriculum. clinicaltrails.gov NCT02501252 dated on July 14, 2015.

Changes in arm-hand function and arm-hand skill performance in patients after stroke during and after rehabilitation

PubMed Central

Smeets, Rob Johannes Elise Marie; Seelen, Henk Alexander Maria

2017-01-01

Background Arm-hand rehabilitation programs applied in stroke rehabilitation frequently target specific populations and thus are less applicable in heterogeneous patient populations. Besides, changes in arm-hand function (AHF) and arm-hand skill performance (AHSP) during and after a specific and well-described rehabilitation treatment are often not well evaluated. Method This single-armed prospective cohort study featured three subgroups of stroke patients with either a severely, moderately or mildly impaired AHF. Rehabilitation treatment consisted of a Concise_Arm_and_hand_ Rehabilitation_Approach_in_Stroke (CARAS). Measurements at function and activity level were performed at admission, clinical discharge, 3, 6, 9 and 12 months after clinical discharge. Results Eighty-nine stroke patients (M/F:63/23; mean age:57.6yr (+/-10.6); post-stroke time:29.8 days (+/-20.1)) participated. All patients improved on AHF and arm-hand capacity during and after rehabilitation, except on grip strength in the severely affected subgroup. Largest gains occurred in patients with a moderately affected AHF. As to self-perceived AHSP, on average, all subgroups improved over time. A small percentage of patients declined regarding self-perceived AHSP post-rehabilitation. Conclusions A majority of stroke patients across the whole arm-hand impairment severity spectrum significantly improved on AHF, arm-hand capacity and self-perceived AHSP. These were maintained up to one year post-rehabilitation. Results may serve as a control condition in future studies. PMID:28614403

The effects of mirror therapy on arm and hand function in subacute stroke in patients.

PubMed

Radajewska, Alina; Opara, Józef A; Kucio, Cezary; Błaszczyszyn, Monika; Mehlich, Krzysztof; Szczygiel, Jarosław

2013-09-01

The aim of this study was to evaluate the effect of mirror therapy on arm and hand function in subacute stroke in patients. The study included 60 hemiparetic right-handed patients after ischemic stroke 8-10 weeks after onset. They underwent stationary comprehensive rehabilitation in the rehabilitation centre. They were divided into two randomly assigned groups: mirror (n=30) and control (n=30). For both groups, two subgroups were created: one that included patients with right arm paresis (n=15) and the other that included patients with left arm paresis (n=15). The mirror group received an additional intervention: training with a mirror for 5 days/week, 2 sessions/day, for 21 days. Each single session lasted for 15 min. The control group (n=30) underwent a conventional rehabilitation program without mirror therapy. To evaluate self-care in performing activities of daily living, the Functional Index 'Repty' was used. To evaluate hand and arm function, the Frenchay Arm Test and the Motor Status Score were used. Measurements were performed twice: before and after 21 days of applied rehabilitation. No significant improvement in hand and arm function in both subgroups in Frenchay Arm Test and Motor Status Score scales was observed. However, there was a significant improvement in self-care of activities of daily living in the right arm paresis subgroup in the mirror group measured using the Functional Index 'Repty'. Mirror therapy improves self-care of activities of daily living for patients with right arm paresis after stroke.

Effective seat-to-head transmissibility in whole-body vibration: Effects of posture and arm position

NASA Astrophysics Data System (ADS)

Rahmatalla, Salam; DeShaw, Jonathan

2011-12-01

Seat-to-head transmissibility is a biomechanical measure that has been widely used for many decades to evaluate seat dynamics and human response to vibration. Traditionally, transmissibility has been used to correlate single-input or multiple-input with single-output motion; it has not been effectively used for multiple-input and multiple-output scenarios due to the complexity of dealing with the coupled motions caused by the cross-axis effect. This work presents a novel approach to use transmissibility effectively for single- and multiple-input and multiple-output whole-body vibrations. In this regard, the full transmissibility matrix is transformed into a single graph, such as those for single-input and single-output motions. Singular value decomposition and maximum distortion energy theory were used to achieve the latter goal. Seat-to-head transmissibility matrices for single-input/multiple-output in the fore-aft direction, single-input/multiple-output in the vertical direction, and multiple-input/multiple-output directions are investigated in this work. A total of ten subjects participated in this study. Discrete frequencies of 0.5-16 Hz were used for the fore-aft direction using supported and unsupported back postures. Random ride files from a dozer machine were used for the vertical and multiple-axis scenarios considering two arm postures: using the armrests or grasping the steering wheel. For single-input/multiple-output, the results showed that the proposed method was very effective in showing the frequencies where the transmissibility is mostly sensitive for the two sitting postures and two arm positions. For multiple-input/multiple-output, the results showed that the proposed effective transmissibility indicated higher values for the armrest-supported posture than for the steering-wheel-supported posture.

Arm Activity During Daily Life in Individuals With Chronic Obstructive Pulmonary Disease.

PubMed

Janaudis-Ferreira, Tania; Mathur, Sunita; Romano, Julia Marie; Goldstein, Roger Samuel; Brooks, Dina

2016-01-01

To determine whether individuals with chronic obstructive pulmonary disease (COPD) have decreased arm activity during daily life compared with healthy controls and explore the relationships between arm activity during daily life and arm functional measures in individuals with COPD. This was a prospective cross-sectional study that included 30 people with COPD and 14 healthy controls. Subjects attended a single assessment session in which measurements of arm exercise capacity, arm functional performance, self-perception of performance during activities of daily living (ADL), shoulder and elbow flexion force and biceps and triceps thickness were performed. On completion of this session, participants were issued a wrist actigraph and asked to wear the device on the dominant arm for 24 hours for 7 consecutive days. Compared with healthy controls, patients with COPD presented decreased total activity level in daily life (P = .001). When corrected for walking, the level of arm activity did not differ between individuals with COPD and healthy controls (P = .62). No correlations were found between arm activity and arm exercise capacity, arm functional performance, upper limb muscle strength, and self-perception of performance during ADL (r =-0.20 to 0.14; all P ≥ .10). Arm activity intensity in individuals with COPD did not differ from that of healthy controls when measured by a wrist actigraph. Moreover, arm activity was not associated with other clinical outcomes of arm function. Disability during ADL is multifactorial, and only limited inferences of function can be made from accelerometer data.

Evaluation of the effectiveness of music therapy in improving the quality of life of palliative care patients: a randomised controlled pilot and feasibility study.

PubMed

McConnell, Tracey; Graham-Wisener, Lisa; Regan, Joan; McKeown, Miriam; Kirkwood, Jenny; Hughes, Naomi; Clarke, Mike; Leitch, Janet; McGrillen, Kerry; Porter, Sam

2016-01-01

Music therapy is frequently used as a palliative therapy. In consonance with the goals of palliative care, the primary aim of music therapy is to improve people's quality of life by addressing their psychological needs and facilitating communication. To date, primarily because of a paucity of robust research, the evidence for music therapy's effectiveness on patient reported outcomes is positive but weak. This pilot and feasibility study will test procedures, outcomes and validated tools; estimate recruitment and attrition rates; and calculate the sample size required for a phase III randomised trial to evaluate the effectiveness of music therapy in improving the quality of life of palliative care patients. A pilot randomised controlled trial supplemented with qualitative methods. The quantitative data collection will involve recruitment of >52 patients from an inpatient Marie Curie hospice setting over a 12-month period. Eligibility criteria include all patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 03- indicating they are medically fit to engage with music therapy and an Abbreviated Mental Test (AMT) score of ≥7 indicating they are capable of providing meaningful informed consent and accurate responses to outcome measures. Baseline data collection will include the McGill Quality of Life Questionnaire (MQOL); medical and socio-demographic data will be undertaken before randomisation to an intervention or control group. Participants in the intervention arm will be offered two 30-45 min sessions of music therapy per week for three consecutive weeks, in addition to care as usual. Participants in the control arm will receive care as usual. Follow-up measures will be administered in 1, 3 and 5 weeks. Qualitative data collection will involve focus group and individual interviews with HCPs and carers. This study will ensure a firm methodological grounding for the development of a robust phase III randomised trial of music therapy for improving quality of life in palliative care patients. By undertaking the pilot and feasibility trial under normal clinical conditions in a hospice setting, the trial will result in reliable procedures to overcome some of the difficulties in designing music therapy RCTs for palliative care settings. Clinicaltrials.gov Identifier: NCT02791048.

Study of Synthetic Vision Systems (SVS) and Velocity-vector Based Command Augmentation System (V-CAS) on Pilot Performance

NASA Technical Reports Server (NTRS)

Liu, Dahai; Goodrich, Ken; Peak, Bob

2006-01-01

This study investigated the effects of synthetic vision system (SVS) concepts and advanced flight controls on single pilot performance (SPP). Specifically, we evaluated the benefits and interactions of two levels of terrain portrayal, guidance symbology, and control-system response type on SPP in the context of lower-landing minima (LLM) approaches. Performance measures consisted of flight technical error (FTE) and pilot perceived workload. In this study, pilot rating, control type, and guidance symbology were not found to significantly affect FTE or workload. It is likely that transfer from prior experience, limited scope of the evaluation task, specific implementation limitations, and limited sample size were major factors in obtaining these results.

Healthy Beyond Pregnancy, a Web-Based Intervention to Improve Adherence to Postpartum Care: Randomized Controlled Feasibility Trial

PubMed Central

Donovan, Heidi; Wang, Stephanie; Weaver, Carrie; Grove, Jillian Rae; Facco, Francesca Lucia

2017-01-01

Background During the postpartum visit, health care providers address issues with short- and long-term implications for maternal and child health. Women with Medicaid insurance are less likely to return for a postpartum visit compared with women with private insurance. Behavioral economics acknowledges that people do not make exclusively rational choices, rather immediate gratification, cognitive and psychological biases, and social norms influence decision making. Drawing on insights from decision science, behavioral economists have examined how these biases can be modulated through carefully designed interventions. We have developed a Web-based tool, Healthy Beyond Pregnancy, that incorporates empirically derived concepts of behavioral economics to improve adherence rates to the postpartum visit. Objectives The primary objectives of this pilot study were to (1) refine and assess the usability of Healthy Beyond Pregnancy and (2) assess the feasibility of a randomized controlled trial (RCT) of the intervention. Methods We used a multistep process and multidisciplinary team of maternal-fetal medicine physicians, a behavioral economist, and researchers with expertise in behavioral interventions to design Healthy Beyond Pregnancy. We assessed the usability of the program with the Post-Study System Usability Questionnaire (PSSUQ), a validated 7-point scale, and semistructured interviews with postpartum women. We then conducted a feasibility trial to determine the proportion of eligible women who were willing to participate in an RCT of Healthy Beyond Pregnancy and the proportion of women willing to complete the Web-based program. Exploratory outcomes of the pilot trial included attendance at the postpartum visit, uptake of long-acting reversible contraception, and uptake of any contraception. Results The median PSSUQ score for Healthy Beyond Pregnancy was 6.5 (interquartile range: 6.1-7) demonstrating high usability. Semistructured interviews (n=10) provided in-depth comments about users’ experience and further improved the program. A total of 34 postpartum women with Medicaid insurance were approached for the pilot trial, and 30 (88%) were consented and randomized. All women randomized to Healthy Beyond Pregnancy completed the Web-based program, had text-enabled cell phones, and were willing to receive text messages from the study team. Women in the Healthy Beyond Pregnancy arm were more likely to return for a postpartum visit compared with women in the control arm with 85% of women in Healthy Beyond Pregnancy returning versus 53% in the control arm (odds ratio in the Healthy Beyond Pregnancy group: 5.3; 95% CI 0.9-32.0; P=.06). Conclusions We have developed a highly usable and acceptable Web-based program designed to increase attendance at the postpartum visit. Our pilot trial demonstrates that women are willing and able to participate in a randomized trial of a Web-based program and text messaging system. Trial Registration Clinicaltrials.gov NCT03296774; https://clinicaltrials.gov/ct2/show/NCT03296774 (Archived by WebCite at http://www.webcitation.org/6tpgXFzyk) PMID:29017990

Compensation for time delay in flight simulator visual-display systems

NASA Technical Reports Server (NTRS)

Crane, D. F.

1983-01-01

A piloted aircraft can be viewed as a closed-loop, man-machine control system. When a simulator pilot is performing a precision maneuver, a delay in the visual display of aircraft response to pilot-control input decreases the stability of the pilot-aircraft system. The less stable system is more difficult to control precisely. Pilot dynamic response and performance change as the pilot attempts to compensate for the decrease in system stability, and these changes bias the simulation results by influencing the pilot's rating of the handling qualities of the simulated aircraft. Delay compensation, designed to restore pilot-aircraft system stability, was evaluated in several studies which are reported here. The studies range from single-axis, tracking-task experiments (with sufficient subjects and trials to establish statistical significance of the results) to a brief evaluation of compensation of a computer-generated-imagery (CGI) visual display system in a full six-degree-of-freedom simulation. The compensation was effective - improvements in pilot performance and workload or aircraft handling-qualities rating (HQR) were observed. Results from recent aircraft handling-qualities research literature which support the compensation design approach are also reviewed.

HYDration and Bicarbonate to Prevent Acute Renal Injury After Endovascular Aneurysm Repair With Suprarenal Fixation: Pilot/Feasibility Randomised Controlled Study (HYDRA Pilot Trial).

PubMed

Saratzis, Athanasios; Chiocchia, Virginia; Jiffry, Ahmad; Hassanali, Neelam; Singh, Surjeet; Imray, Christopher H; Bown, Matthew J; Mahmood, Asif

2018-05-01

Up to 25% of patients undergoing elective endovascular aneurysm repair (EVAR) develop acute kidney injury (AKI), which is associated with short and long-term morbidity and mortality. There is no high quality randomised evidence regarding prevention of EVAR related AKI. A novel AKI prevention strategy for EVAR was devised, based on best evidence and an expert consensus group. This included a bolus of high dose sodium bicarbonate (NaHCO 3 ) immediately before EVAR (1 mL/kg of 8.4% NaHCO 3 ) and standardised crystalloid based hydration pre- and post-EVAR. A pilot/feasibility randomised controlled trial (RCT) was performed in two centres to assess the safety of the intervention, potential impact on AKI prevention, and feasibility of a national RCT; the primary end point was the proportion of eligible patients recruited into the study. AKI was defined using "Kidney Disease Improving Global Outcomes" and "Acute Kidney Injury Network" criteria based on National Institute for Health and Clinical Excellence AKI recommendations, using serum creatinine and hourly urine output. Fifty-eight patients (84% of those screened; median age 75 years [range 57-89 years], 10% female) were randomised to receive the standardised intravenous hydration with (intervention) or without (control) NaHCO 3 . Groups were comparable in terms of AKI risk factors; 56 of 58 participants had a device with suprarenal fixation. Overall, 33% of patients in the control arm developed AKI versus 7% in the intervention arm (as treated analysis). None of the patients receiving NaHCO 3 developed a serious intervention related adverse event; five patients did not attend their 30 day follow-up. Bolus high dose NaHCO 3 and hydration is a promising EVAR related AKI prevention method. This trial has confirmed the feasibility of delivering a definitive large RCT to confirm the efficacy of this novel intervention, in preventing EVAR related AKI. Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

Mixed response and time-to-event endpoints for multistage single-arm phase II design.

PubMed

Lai, Xin; Zee, Benny Chung-Ying

2015-06-04

The objective of phase II cancer clinical trials is to determine if a treatment has sufficient activity to warrant further study. The efficiency of a conventional phase II trial design has been the object of considerable debate, particularly when the study regimen is characteristically cytostatic. At the time of development of a phase II cancer trial, we accumulated clinical experience regarding the time to progression (TTP) for similar classes of drugs and for standard therapy. By considering the time to event (TTE) in addition to the tumor response endpoint, a mixed-endpoint phase II design may increase the efficiency and ability of selecting promising cytotoxic and cytostatic agents for further development. We proposed a single-arm phase II trial design by extending the Zee multinomial method to fully use mixed endpoints with tumor response and the TTE. In this design, the dependence between the probability of response and the TTE outcome is modeled through a Gaussian copula. Given the type I and type II errors and the hypothesis as defined by the response rate (RR) and median TTE, such as median TTP, the decision rules for a two-stage phase II trial design can be generated. We demonstrated through simulation that the proposed design has a smaller expected sample size and higher early stopping probability under the null hypothesis than designs based on a single-response endpoint or a single TTE endpoint. The proposed design is more efficient for screening new cytotoxic or cytostatic agents and less likely to miss an effective agent than the alternative single-arm design.

HIV risk behavior before and after HIV counseling and testing in jail: a pilot study.

PubMed

Beckwith, Curt G; Liu, Tao; Bazerman, Lauri B; DeLong, Allison K; Desjardins, Simon F; Poshkus, Michael M; Flanigan, Timothy P

2010-04-01

Jail incarceration represents an opportunity to deliver HIV counseling and testing (C&T) services to persons at increased risk of infection. However, jails can be chaotic with rapid turnover of detainees. We conducted a pilot study to investigate the feasibility of comparing the effect of different approaches to HIV C&T in jail on subsequent HIV risk behaviors among persons testing HIV negative. Consecutive cohorts of newly incarcerated jail detainees were recruited with 132 subjects completing standard HIV C&T as per jail protocol and 132 subjects completing rapid testing with an individualized counseling session. Risk behavior was assessed and compared at baseline and 6 weeks after jail release. Among the 264 male participants, preincarceration substance use and sexual risk were common. The follow-up visit was completed by 59% of eligible participants. There were no differences in postrelease HIV risk behavior between the 2 arms but there was an overall decrease in risk behavior after jail release for the cohort. In addition, all participants in the rapid arm received rapid HIV test results compared with participants receiving 28% of conventional test results. Jail incarceration represents an important public health opportunity to deliver HIV C&T. This study demonstrated (1) feasibility in delivering rapid HIV testing combined with individualized counseling to jail detainees, (2) improved test result delivery rates, and (3) success with evaluating risk behaviors during the transition from jail to the community. Further research is needed to determine the optimal approach to HIV C&T in jail with the goal of increasing awareness of HIV serostatus and decreasing HIV risk behavior.

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.

Effects of training with a passive hand orthosis and games at home in chronic stroke: a pilot randomised controlled trial.

PubMed

Nijenhuis, Sharon M; Prange-Lasonder, Gerdienke B; Stienen, Arno Ha; Rietman, Johan S; Buurke, Jaap H

2017-02-01

To compare user acceptance and arm and hand function changes after technology-supported training at home with conventional exercises in chronic stroke. Secondly, to investigate the relation between training duration and clinical changes. A randomised controlled trial. Training at home, evaluation at research institute. Twenty chronic stroke patients with severely to mildly impaired arm and hand function. Participants were randomly assigned to six weeks (30 minutes per day, six days a week) of self-administered home-based arm and hand training using either a passive dynamic wrist and hand orthosis combined with computerised gaming exercises (experimental group) or prescribed conventional exercises from an exercise book (control group). Main outcome measures are the training duration for user acceptance and the Action Research Arm Test for arm and hand function. Secondary outcomes are the Intrinsic Motivation Inventory, Fugl-Meyer assessment, Motor Activity Log, Stroke Impact Scale and grip strength. The control group reported a higher training duration (189 versus 118 minutes per week, P = 0.025). Perceived motivation was positive and equal between groups ( P = 0.935). No differences in clinical outcomes over training between groups were found (P ⩾ 0.165). Changes in Box and Block Test correlated positively with training duration ( P = 0.001). Both interventions were accepted. An additional benefit of technology-supported arm and hand training over conventional arm and hand exercises at home was not demonstrated. Training duration in itself is a major contributor to arm and hand function improvements.

The Effect of Lateral-Directional Control Coupling on Pilot Control of an Airplane as Determined in Flight and in a Fixed-Base Flight Simulator

NASA Technical Reports Server (NTRS)

Vomaske, Richard F.; Sadoff, Melvin; Drinkwater, Fred J., III

1961-01-01

A flight and fixed-base simulator study was made of the effects of aileron-induced yaw on pilot opinion of aircraft lateral-directional controllability characteristics. A wide range of adverse and favorable aileron-induced yaw was investigated in flight at several levels of Dutch-roll damping. The flight results indicated that the optimum values of aileron- induced yaw differed only slightly from zero for Dutch-roll damping from satisfactory to marginally controllable levels. It was also shown that each range of values of aileron-induced yawing moment considered satisfactory, acceptable, or controllable increased with an increase in the Dutch- roll damping. The increase was most marked for marginally controllable configurations exhibiting favorable aileron-induced yaw. Comparison of fixed-base flight simulator results with flight results showed agreement, indicating that absence of kinesthetic motion cues did not markedly affect the pilots' evaluation of the type of control problem considered in this study. The results of the flight study were recast in terms of several parameters which were considered to have an important effect on pilot opinion of lateral-directional handling qualities, including the effects of control coupling. Results of brief tests with a three-axis side-arm controller indicated that for control coupling problems associated with highly favorable yaw and cross-control techniques, use of the three-axis controller resulted in a deterioration of control relative to results obtained with the conventional center stick and rudder pedals.

Analysis of allelic expression patterns in clonal somatic cells by single-cell RNA-seq

PubMed Central

Ramsköld, Daniel; Deng, Qiaolin; Johnsson, Per; Michaëlsson, Jakob; Frisén, Jonas; Sandberg, Rickard

2016-01-01

Cellular heterogeneity can emerge from the expression of only one parental allele. However, it has remained controversial whether, or to what degree, random monoallelic expression of autosomal genes (aRME) is mitotically inherited (clonal) or stochastic (dynamic) in somatic cells, particularly in vivo. Here, we used allele-sensitive single-cell RNA-seq on clonal primary mouse fibroblasts and in vivo human CD8+ T-cells to dissect clonal and dynamic monoallelic expression patterns. Dynamic aRME affected a considerable portion of the cells’ transcriptomes, with levels dependent on the cells’ transcriptional activity. Importantly, clonal aRME was detected but was surprisingly scarce (<1% of genes) and affected mainly the most low-expressed genes. Consequently, the overwhelming portion of aRME occurs transiently within individual cells and patterns of aRME are thus primarily scattered throughout somatic cell populations rather than, as previously hypothesized, confined to patches of clonally related cells. PMID:27668657

Analysis of allelic expression patterns in clonal somatic cells by single-cell RNA-seq.

PubMed

Reinius, Björn; Mold, Jeff E; Ramsköld, Daniel; Deng, Qiaolin; Johnsson, Per; Michaëlsson, Jakob; Frisén, Jonas; Sandberg, Rickard

2016-11-01

Cellular heterogeneity can emerge from the expression of only one parental allele. However, it has remained controversial whether, or to what degree, random monoallelic expression of autosomal genes (aRME) is mitotically inherited (clonal) or stochastic (dynamic) in somatic cells, particularly in vivo. Here we used allele-sensitive single-cell RNA-seq on clonal primary mouse fibroblasts and freshly isolated human CD8 + T cells to dissect clonal and dynamic monoallelic expression patterns. Dynamic aRME affected a considerable portion of the cells' transcriptomes, with levels dependent on the cells' transcriptional activity. Notably, clonal aRME was detected, but it was surprisingly scarce (<1% of genes) and mainly affected the most weakly expressed genes. Consequently, the overwhelming majority of aRME occurs transiently within individual cells, and patterns of aRME are thus primarily scattered throughout somatic cell populations rather than, as previously hypothesized, confined to patches of clonally related cells.

An Investigation of the Ability to Recover from Transients Following Failures for Single-Pilot Rotorcraft

NASA Technical Reports Server (NTRS)

Mansur, M. Hossein; Schroeder, Jeffery A.

1988-01-01

A moving-base simulation was conducted to investigate a pilot's ability to recover from transients following single-axis hard-over failures of the flight-control system. The investigation was performed in conjunction with a host simulation that examined the influence of control modes on a single pilot's ability to perform various mission elements under high-workload conditions. The NASA Ames large-amplitude-motion Vertical Motion Simulator (VMS) was utilized, and the experimental variables were the failure axis, the severity of the failure, and the airspeed at which the failure occurred. Other factors, such as pilot workload and terrain and obstacle proximity at the time of failure, were kept as constant as possible within the framework of the host simulation task scenarios. No explicit failure warnings were presented to the pilot. Data from the experiment are shown, and pilot ratings are compared with the proposed handling-qualities requirements for military rotorcraft. Results indicate that the current proposed failure transient requirements may need revision.

Internet Mindfulness Meditation Intervention for the General Public: Pilot Randomized Controlled Trial

PubMed Central

2016-01-01

Background Mindfulness meditation interventions improve a variety of health conditions and quality of life, are inexpensive, easy to implement, have minimal if any side effects, and engage patients to take an active role in their treatment. However, the group format can be an obstacle for many to take structured meditation programs. Internet Mindfulness Meditation Intervention (IMMI) is a program that could make mindfulness meditation accessible to all people who want and need to receive it. However, the feasibility, acceptability, and ability of IMMI to increase meditation practice have yet to be evaluated. Objectives The primary objectives of this pilot randomized controlled study were to (1) evaluate the feasibility and acceptability of IMMIs in the general population and (2) to evaluate IMMI’s ability to change meditation practice behavior. The secondary objective was to collect preliminary data on health outcomes. Methods Potential participants were recruited from online and offline sources. In a randomized controlled trial, participants were allocated to IMMI or Access to Guided Meditation arm. IMMI included a 1-hour Web-based training session weekly for 6 weeks along with daily home practice guided meditations between sessions. The Access to Guided Meditation arm included a handout on mindfulness meditation and access to the same guided meditation practices that the IMMI participants received, but not the 1-hour Web-based training sessions. The study activities occurred through the participants’ own computer and Internet connection and with research-assistant telephone and email contact. Feasibility and acceptability were measured with enrollment and completion rates and participant satisfaction. The ability of IMMI to modify behavior and increase meditation practice was measured by objective adherence of daily meditation practice via Web-based forms. Self-report questionnaires of quality of life, self-efficacy, depression symptoms, sleep disturbance, perceived stress, and mindfulness were completed before and after the intervention period via Web-based surveys. Results We enrolled 44 adults were enrolled and 31 adults completed all study activities. There were no group differences on demographics or important variables at baseline. Participants rated the IMMI arm higher than the Access to Guided Meditation arm on Client Satisfaction Questionnaire. IMMI was able to increase home practice behavior significantly compared to the Access to Guided Meditation arm: days practiced (P=.05), total minutes (P=.01), and average minutes (P=.05). As expected, there were no significant differences on health outcomes. Conclusions In conclusion, IMMI was found to be feasible and acceptable. The IMMI arm had increased daily meditation practice compared with the Access to Guided Meditation control group. More interaction through staff and/or through built-in email or text reminders may increase daily practice even more. Future studies will examine IMMI’s efficacy at improving health outcomes in the general population and also compare it directly to the well-studied mindfulness-based group interventions to evaluate relative efficacy. Trial Registration Clinicaltrials.gov NCT02655835; http://clinicaltrials.gov/ct2/show/NCT02655835 (Archived by WebCite at http://www.webcitation/ 6jUDuQsG2) PMID:27502759

Front-Line Advocacy: Fighting Off a Voucher Measure

ERIC Educational Resources Information Center

Grimesey, Robert P., Jr.

2012-01-01

In September 2010, the U.S. Senate's Armed Services Committee approved an amendment to the proposed National Defense Authorization Act. The amendment, known as Section 583, authorized a Defense Department pilot voucher program to mitigate the cost of private school tuition for special-needs children of military parents. Sen. Jim Webb, a member of…

The Constitution by Cell

ERIC Educational Resources Information Center

Greenhut, Stephanie; Jones, Megan

2010-01-01

On their visit to the National Archives Experience in Washington, D.C., students in Jenni Ashley and Gay Brock's U.S. history classes at the Potomac School in McLean, Virginia, participated in a pilot program called "The Constitution by Cell." Armed with their cell phones, a basic understanding of the Constitution, and a willingness to…

Tuskegee Airman Lee Hayes

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

Hayes, Lee

2006-08-03

Hayes, a resident of Amagansett who worked at Brookhaven Lab as a custodian from 1958 to 1966, served in an all-black bomber squadron at Tuskegee Army Air Field in Alabama. He was among 994 precedent-breaking black soldiers at Tuskegee who passed rigorous tests between 1942 and 1946 to become pilots in the then-segregated armed forces.

76 FR 60459 - 36(b)(1) Arms Sales Notification

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-29

... Consideration for Purchase: continuation of a pilot training program and logistics support for F-16 aircraft at... program and logistics support for F-16 aircraft at Luke Air Force Base, Arizona to include flight training..., which will contribute to an acceptable military balance in the area. This proposed sale is consistent...

77 FR 42704 - 36(b)(1) Arms Sales Notification

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-20

... Vision Sensors, 12 AN/APG-78 Fire Control Radars (FCR) with Radar Electronics Unit (LONGBOW component... Target Acquisition and Designation Sight, 27 AN/AAR-11 Modernized Pilot Night Vision Sensors, 12 AN/APG... enhance the protection of key oil and gas infrastructure and platforms which are vital to U.S. and western...

Tuskegee Airman Lee Hayes

ScienceCinema

Hayes, Lee

2017-12-22

Hayes, a resident of Amagansett who worked at Brookhaven Lab as a custodian from 1958 to 1966, served in an all-black bomber squadron at Tuskegee Army Air Field in Alabama. He was among 994 precedent-breaking black soldiers at Tuskegee who passed rigorous tests between 1942 and 1946 to become pilots in the then-segregated armed forces.

Jim Crow, Uncle Sam, and the Formation of the Tuskegee Flying Units.

ERIC Educational Resources Information Center

Percy, William

1999-01-01

Delivers background information on the political origins and confrontations surrounding the "Tuskegee Experiment." States that the success of the Tuskegee pilots, in their role as strategic escort for the Fifteenth Air Force, paved the way for the overall desegregation of U.S. armed forces. Provides teaching ideas along with two…

The Pittsburgh Randomized Trial of Tacrolimus Compared to Cyclosporine for Hepatic Transplantation

PubMed Central

Fung, John J.; Eliasziw, Michael; Todo, Satoru; Jain, Ashok; Demetris, Anthony J.; McMichael, John P.; Starzl, Thomas E.; Meier, Paul; Donner, Allan

2009-01-01

Background Tacrolimus (formerly FK 506) was first used clinically in 1989 to successfully replace cyclosporine in hepatic transplant recipients who were experiencing intractable rejection or as the baseline drug from the time of operation. After extensive pilot experience, an institutional review board-mandated clinical trial comparing cyclosporine with tacrolimus was performed. Study Design From February 16, 1990 to December 26, 1991, 154 patients were recruited. The competing drugs were combined with equal induction doses of prednisone in both arms of the study for the first 81 patients and with subsequently higher doses of prednisone in the remaining 35 patients who received cyclosporine and were entered into the trial. Drug crossover was permitted for lack of efficacy or adverse events. End points were rejection confirmed by biopsy and treatment failure leading to retransplantation or death. Results Seventy-nine patients were randomized to the tacrolimus arm and 75 to the cyclosporine arm during 1990 and 1991. All patients were available for follow-up throughout the trial, which terminated on May 30, 1995. The mean duration of follow-up was four years. Patients randomized to the tacrolimus arm were less likely to experience acute rejection than were those receiving cyclosporine, with 36.2 percent of the patients receiving tacrolimus and 16.8 percent of the patients receiving cyclosporine showing freedom from rejection at one year (p=0.003, likelihood ratio test). Survival of patients over the course of the study was virtually the same in the two groups. Conclusions Tacrolimus was more effective than cyclosporine in preventing acute rejection. PMID:8696542

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.

Palliative radiotherapy in addition to self-expanding metal stent for improving dysphagia and survival in advanced oesophageal cancer (ROCS: Radiotherapy after Oesophageal Cancer Stenting): study protocol for a randomized controlled trial.

PubMed

Adamson, Douglas; Blazeby, Jane; Nelson, Annmarie; Hurt, Chris; Nixon, Lisette; Fitzgibbon, Jim; Crosby, Tom; Staffurth, John; Evans, Mim; Kelly, Noreen Hopewell; Cohen, David; Griffiths, Gareth; Byrne, Anthony

2014-10-22

The single most distressing symptom for patients with advanced esophageal cancer is dysphagia. Amongst the more effective treatments for relief of dysphagia is insertion of a self-expanding metal stent (SEMS). It is possible that the addition of a palliative dose of external beam radiotherapy may prolong the relief of dysphagia and provide additional survival benefit. The ROCS trial will assess the effect of adding palliative radiotherapy after esophageal stent insertion. The study is a randomized multicenter phase III trial, with an internal pilot phase, comparing stent alone versus stent plus palliative radiotherapy in patients with incurable esophageal cancer. Eligible participants are those with advanced esophageal cancer who are in need of stent insertion for primary management of dysphagia. Radiotherapy will be administered as 20 Gray (Gy) in five fractions over one week or 30 Gy in 10 fractions over two weeks, within four weeks of stent insertion. The internal pilot will assess rates and methods of recruitment; pre-agreed criteria will determine progression to the main trial. In total, 496 patients will be randomized in a 1:1 ratio with follow up until death. The primary outcome is time to progression of patient-reported dysphagia. Secondary outcomes include survival, toxicity, health resource utilization, and quality of life. An embedded qualitative study will explore the feasibility of patient recruitment by examining patients' motivations for involvement and their experiences of consent and recruitment, including reasons for not consenting. It will also explore patients' experiences of each trial arm. The ROCS study will be a challenging trial studying palliation in patients with a poor prognosis. The internal pilot design will optimize methods for recruitment and data collection to ensure that the main trial is completed on time. As a pragmatic trial, study strengths include collection of all follow-up data in the usual place of care, and a focus on patient-reported, rather than disease-orientated, outcomes. Exploration of patient experience and health economic analyses will be integral to the assessment of benefit for patients and the NHS. The trial was registered with Current Controlled Trials (registration number: ISRCTN12376468) on 10 July 2012.

Towards Rehabilitation Robotics: Off-the-Shelf BCI Control of Anthropomorphic Robotic Arms.

PubMed

Athanasiou, Alkinoos; Xygonakis, Ioannis; Pandria, Niki; Kartsidis, Panagiotis; Arfaras, George; Kavazidi, Kyriaki Rafailia; Foroglou, Nicolas; Astaras, Alexander; Bamidis, Panagiotis D

2017-01-01

Advances in neural interfaces have demonstrated remarkable results in the direction of replacing and restoring lost sensorimotor function in human patients. Noninvasive brain-computer interfaces (BCIs) are popular due to considerable advantages including simplicity, safety, and low cost, while recent advances aim at improving past technological and neurophysiological limitations. Taking into account the neurophysiological alterations of disabled individuals, investigating brain connectivity features for implementation of BCI control holds special importance. Off-the-shelf BCI systems are based on fast, reproducible detection of mental activity and can be implemented in neurorobotic applications. Moreover, social Human-Robot Interaction (HRI) is increasingly important in rehabilitation robotics development. In this paper, we present our progress and goals towards developing off-the-shelf BCI-controlled anthropomorphic robotic arms for assistive technologies and rehabilitation applications. We account for robotics development, BCI implementation, and qualitative assessment of HRI characteristics of the system. Furthermore, we present two illustrative experimental applications of the BCI-controlled arms, a study of motor imagery modalities on healthy individuals' BCI performance, and a pilot investigation on spinal cord injured patients' BCI control and brain connectivity. We discuss strengths and limitations of our design and propose further steps on development and neurophysiological study, including implementation of connectivity features as BCI modality.

Towards Rehabilitation Robotics: Off-the-Shelf BCI Control of Anthropomorphic Robotic Arms

PubMed Central

Xygonakis, Ioannis; Pandria, Niki; Kartsidis, Panagiotis; Arfaras, George; Kavazidi, Kyriaki Rafailia; Foroglou, Nicolas

2017-01-01

Advances in neural interfaces have demonstrated remarkable results in the direction of replacing and restoring lost sensorimotor function in human patients. Noninvasive brain-computer interfaces (BCIs) are popular due to considerable advantages including simplicity, safety, and low cost, while recent advances aim at improving past technological and neurophysiological limitations. Taking into account the neurophysiological alterations of disabled individuals, investigating brain connectivity features for implementation of BCI control holds special importance. Off-the-shelf BCI systems are based on fast, reproducible detection of mental activity and can be implemented in neurorobotic applications. Moreover, social Human-Robot Interaction (HRI) is increasingly important in rehabilitation robotics development. In this paper, we present our progress and goals towards developing off-the-shelf BCI-controlled anthropomorphic robotic arms for assistive technologies and rehabilitation applications. We account for robotics development, BCI implementation, and qualitative assessment of HRI characteristics of the system. Furthermore, we present two illustrative experimental applications of the BCI-controlled arms, a study of motor imagery modalities on healthy individuals' BCI performance, and a pilot investigation on spinal cord injured patients' BCI control and brain connectivity. We discuss strengths and limitations of our design and propose further steps on development and neurophysiological study, including implementation of connectivity features as BCI modality. PMID:28948168

Virtual reality games for rehabilitation of people with stroke: perspectives from the users.

PubMed

Lewis, Gwyn N; Woods, Claire; Rosie, Juliet A; McPherson, Kathryn M

2011-01-01

PURPOSE. The purpose of this study is to evaluate the feasibility and users' perspectives of a novel virtual reality (VR) game-based rehabilitation intervention for people with stroke. METHOD. Six people with upper limb hemiplegia participated in a 6-week intervention that involved VR games. A series of eight progressively complex games was developed that required participants to navigate a submarine in a virtual ocean environment. Movement of the submarine was directed by forces applied to an arm interface by the affected limb. Outcome measures included assessments of arm function, questionnaires evaluating the intervention and a semi-structured interview concerning the participants' opinion of the intervention. RESULTS. All participants improved their performance on the games, although there were limited changes in clinical measures of arm function. All participants reported that they enjoyed the intervention with a wide range of overall perceptions of the experience of using VR. Three themes emerging from the interview data were: stretching myself, purpose and expectations of the intervention and future improvements. CONCLUSIONS. Participants found that taking part in this pilot study was enjoyable and challenging. Participants' feedback suggested that the games may be motivating and engaging for future users and have provided a basis for further development of the intervention.

Identifying Issues and Concerns with the Use of Interval-Based Systems in Single Case Research Using a Pilot Simulation Study

ERIC Educational Resources Information Center

Ledford, Jennifer R.; Ayres, Kevin M.; Lane, Justin D.; Lam, Man Fung

2015-01-01

Momentary time sampling (MTS), whole interval recording (WIR), and partial interval recording (PIR) are commonly used in applied research. We discuss potential difficulties with analyzing data when these systems are used and present results from a pilot simulation study designed to determine the extent to which these issues are likely to be…

Video Modeling for Teaching Daily Living Skills to Children with Autism Spectrum Disorder: A Pilot Study

ERIC Educational Resources Information Center

Meister, Christine; Salls, Joyce

2015-01-01

This pilot study investigated the efficacy of point-of-view video modeling as an intervention strategy to improve self-help skills in children with autism spectrum disorder (ASD). A single-subject A-B design was implemented with eight school-aged children ages 7.5 years to 13.5 years. Six of the students participated in general education classes…

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.

The Faceted Discrete Growth and Phase Differentiation During the Directional Solidification of 20SiMnMo5 Steel

NASA Astrophysics Data System (ADS)

Ma, Xiaoping; Li, Dianzhong

2018-07-01

The microstructures, segregation and cooling curve were investigated in the directional solidification of 20SiMnMo5 steel. The typical characteristic of faceted growth is identified. The microstructures within the single cellular and within the single dendritic arm, together with the contradictive segregation distribution against the cooling curve, verify the discrete crystal growth in multi-scales. Not only the single cellular/dendritic arm but also the single martensite zone within the single cellular/dendritic arm is produced by the discrete growth. In the viewpoint of segregation, the basic domain following continuous growth has not been revealed. Along with the multi-scale faceted discrete growth, the phase differentiation happens for both the solid and liquid. The differentiated liquid phases appear and evolve with different sizes, positions, compositions and durations. The physical mechanism for the faceted discrete growth is qualitatively established based on the nucleation of new faceted steps induced by the composition gradient and temperature gradient.

The Faceted Discrete Growth and Phase Differentiation During the Directional Solidification of 20SiMnMo5 Steel

NASA Astrophysics Data System (ADS)

Ma, Xiaoping; Li, Dianzhong

2018-03-01

The microstructures, segregation and cooling curve were investigated in the directional solidification of 20SiMnMo5 steel. The typical characteristic of faceted growth is identified. The microstructures within the single cellular and within the single dendritic arm, together with the contradictive segregation distribution against the cooling curve, verify the discrete crystal growth in multi-scales. Not only the single cellular/dendritic arm but also the single martensite zone within the single cellular/dendritic arm is produced by the discrete growth. In the viewpoint of segregation, the basic domain following continuous growth has not been revealed. Along with the multi-scale faceted discrete growth, the phase differentiation happens for both the solid and liquid. The differentiated liquid phases appear and evolve with different sizes, positions, compositions and durations. The physical mechanism for the faceted discrete growth is qualitatively established based on the nucleation of new faceted steps induced by the composition gradient and temperature gradient.

Educational intervention for physicians to address the risk of opioid abuse.

PubMed

Pasquale, Margaret K; Sheer, Richard L; Mardekian, Jack; Masters, Elizabeth T; Patel, Nick C; Hurwitch, Amy R; Weber, Jennifer J; Jorga, Anamaria; Roland, Carl L

To evaluate the impact of a pilot intervention for physicians to support their treatment of patients at risk for opioid abuse. Patients at risk for opioid abuse enrolled in Medicare plans were identified from July 1, 2012 to April 30, 2014 (N = 2,391), based on a published predictive model, and linked to 4,353 opioid-prescribing physicians. Patient-physician clusters were randomly assigned to one of four interventions using factorial design. Physicians received one of the following: Arm 1, patient information; Arm 2, links to educational materials for diagnosis and management of pain; Arm 3, both patient information and links to educational materials; or Arm 4, no communication. Difference-in-difference analyses compared opioid and pain prescriptions, chronic high-dose opioid use, uncoordinated opioid use, and opioid-related emergency department (ED) visits. Logistic regression compared diagnosis of opioid abuse between cases and controls postindex. Mailings had no significant impact on numbers of opioid or pain medications filled, chronic high-dose opioid use, uncoordinated opioid use, ED visits, or rate of diagnosed opioid abuse. Relative to Arm 4, odds ratios (95% CI) for diagnosed opioid abuse were Arm 1, 0.95(0.63-1.42); Arm 2, 0.83(0.55-1.27); Arm 3, 0.72(0.46-1.13). While 84.7 percent had ≥1 psychiatric diagnoses during preindex (p = 0.89 between arms), only 9.5 percent had ≥1 visit with mental health specialists (p = 0.53 between arms). Although this intervention did not affect pain-related outcomes, future interventions involving care coordination across primary care and mental health may impact opioid abuse and improve quality of life of patients with pain.

A feasibility study to determine the benefits of upper extremity virtual rehabilitation therapy for coping with chronic pain post-cancer surgery

PubMed Central

House, Gregory; Burdea, Grigore; Grampurohit, Namrata; Polistico, Kevin; Roll, Doru; Damiani, Frank; Hundal, Jasdeep; Demesmin, Didier

2016-01-01

Background: Persistent pain in shoulder and arm following post-surgical breast cancer treatment can lead to cognitive and physical deficits. Depression is also common in breast cancer survivors. Virtual reality therapy with integrative cognitive and physical rehabilitation has not been clinically trialed for this population. The novel BrightArm Duo technology improved cognition and upper extremity (UE) function for other diagnoses and has great potential to benefit individuals coping with post-surgical breast cancer pain. Objectives: The aim of this study was to explore the feasibility of BrightArm Duo therapy for coping with post-surgical chronic pain and associated disability in breast cancer survivors with depression. Methods: BrightArm Duo is a robotic rehabilitation table modulating gravity loading on supported forearms. It tracks arm position and grasping strength while patients play three-dimensional (3D) custom integrative rehabilitation games. Community-dwelling women (N = 6) with post-surgical breast cancer pain in the upper arm trained on the system twice a week for 8 weeks. Training difficulty increased progressively in game complexity, table tilt and session length (20–50 minutes). Standardized assessments were performed before and after therapy for pain, cognition, emotion, UE function and activities of daily living. Results: Subjects averaged upwards of 1300 arm repetitions and 850 hand grasps per session. Pain intensity showed a 20% downward trend (p = 0.1) that was corroborated by therapist observations and participant feedback. A total of 10 out of 11 cognitive metrics improved post-training (p = 0.01) with a significant 8.3-point reduction in depression severity (p = 0.04). A total of 17 of 18 range of motion metrics increased (p < 0.01), with five affected-side shoulder improvements above the Minimal Clinically Important Difference (8°). In all, 13 out of 15 strength and function metrics improved (p = 0.02) with lateral deltoid strength increasing 7.4 N on the affected side (p = 0.05). Conclusion: This pilot study demonstrated feasibility of using the BrightArm Duo Rehabilitation System to treat cancer survivors coping with upper body chronic pain. Outcomes indicate improvement in cognition, shoulder range, strength, function and depression. PMID:27867508

A feasibility study to determine the benefits of upper extremity virtual rehabilitation therapy for coping with chronic pain post-cancer surgery.

PubMed

House, Gregory; Burdea, Grigore; Grampurohit, Namrata; Polistico, Kevin; Roll, Doru; Damiani, Frank; Hundal, Jasdeep; Demesmin, Didier

2016-11-01

Persistent pain in shoulder and arm following post-surgical breast cancer treatment can lead to cognitive and physical deficits. Depression is also common in breast cancer survivors. Virtual reality therapy with integrative cognitive and physical rehabilitation has not been clinically trialed for this population. The novel BrightArm Duo technology improved cognition and upper extremity (UE) function for other diagnoses and has great potential to benefit individuals coping with post-surgical breast cancer pain. The aim of this study was to explore the feasibility of BrightArm Duo therapy for coping with post-surgical chronic pain and associated disability in breast cancer survivors with depression. BrightArm Duo is a robotic rehabilitation table modulating gravity loading on supported forearms. It tracks arm position and grasping strength while patients play three-dimensional (3D) custom integrative rehabilitation games. Community-dwelling women (N = 6) with post-surgical breast cancer pain in the upper arm trained on the system twice a week for 8 weeks. Training difficulty increased progressively in game complexity, table tilt and session length (20-50 minutes). Standardized assessments were performed before and after therapy for pain, cognition, emotion, UE function and activities of daily living. Subjects averaged upwards of 1300 arm repetitions and 850 hand grasps per session. Pain intensity showed a 20% downward trend (p = 0.1) that was corroborated by therapist observations and participant feedback. A total of 10 out of 11 cognitive metrics improved post-training (p = 0.01) with a significant 8.3-point reduction in depression severity (p = 0.04). A total of 17 of 18 range of motion metrics increased (p < 0.01), with five affected-side shoulder improvements above the Minimal Clinically Important Difference (8°). In all, 13 out of 15 strength and function metrics improved (p = 0.02) with lateral deltoid strength increasing 7.4 N on the affected side (p = 0.05). This pilot study demonstrated feasibility of using the BrightArm Duo Rehabilitation System to treat cancer survivors coping with upper body chronic pain. Outcomes indicate improvement in cognition, shoulder range, strength, function and depression.

Effects and effectiveness of dynamic arm supports: a technical review.

PubMed

van der Heide, Loek A; Gelderblom, Gert Jan; de Witte, Luc P

2015-01-01

Numerous dynamic arm supports have been developed in recent decades to increase independence in the performance of activities of daily living. Much effort and money have been spent on their development and prescription, yet insight into their effects and effectiveness is lacking. This article is a systematic review of evaluations of dynamic arm supports. The 8 technical evaluations, 12 usability evaluations, and 27 outcome studies together make 47 evaluations. Technical evaluations were often used as input for new developments and directed at balancing quality, forces and torques, and range of motion of prototypes. Usability studies were mostly single-measure designs that had varying results as to whether devices were usable for potential users. An increased ability to perform activities of daily living and user satisfaction were reported in outcome studies. However, the use of dynamic arm supports in the home situation was reported to be low. Gaining insight into why devices are not used when their developers believe them to be effective seems crucial for every new dynamic arm support developed. The methodological quality of the outcome studies was often low, so it is important that this is improved in the future.

The effects of display and autopilot functions on pilot workload for Single Pilot Instrument Flight Rule (SPIFR) operations

NASA Technical Reports Server (NTRS)

Hoh, Roger H.; Smith, James C.; Hinton, David A.

1987-01-01

An analytical and experimental research program was conducted to develop criteria for pilot interaction with advanced controls and displays in single pilot instrument flight rules (SPIFR) operations. The analytic phase reviewed fundamental considerations for pilot workload taking into account existing data, and using that data to develop a divided attention SPIFR pilot workload model. The pilot model was utilized to interpret the two experimental phases. The first experimental phase was a flight test program that evaluated pilot workload in the presence of current and near-term displays and autopilot functions. The second experiment was conducted on a King Air simulator, investigating the effects of co-pilot functions in the presence of very high SPIFR workload. The results indicate that the simplest displays tested were marginal for SPIFR operations. A moving map display aided the most in mental orientation, but had inherent deficiencies as a stand alone replacement for an HSI. Autopilot functions were highly effective for reducing pilot workload. The simulator tests showed that extremely high workload situations can be adequately handled when co-pilot functions are provided.

Home Based Care as an Approach to Improve the Efficiency of treatment for MDR Tuberculosis: A Quasi-Experimental Pilot Study

PubMed Central

Taneja, Neha; Daral, Shailaja; Adhikary, Mrinmoy; Das, Timiresh Kumar

2017-01-01

Introduction Multi Drug Resistant Tuberculosis (MDR TB) has emerged as a significant public health problem in India. The prolonged treatment duration in MDR TB is a challenge in achieving treatment completion and poses a threat to TB control in the country. Home based care is an approach accepted by patients because it helps in ameliorating their understanding of TB, improving the compliance and reducing stigma in the community. Aim To assess the outcome of Home-Based Care (HC) versus No Home-Based Care (NHC) on the treatment of MDR TB patients registered at two chest clinics in Eastern Delhi. Materials and Methods A quasi-experimental study was done among diagnosed MDR TB patients receiving Category IV regimen under Revised National Tuberculosis Control Programme (RNTCP) from two government chest clinics in Eastern Delhi during May 2014 to May 2016. In the control arm, 50 MDR TB patients at one of the chest clinics were offered the standard Category IV regimen under RNTCP; while in the intervention arm, 50 MDR TB patients at the second chest clinic were provided home based care (counselling, support for completion of treatment, rehabilitation, and nutritional support) along with the standard treatment. The primary outcome assessed was outcome of treatment, while secondary outcomes included stigma faced due to the disease, and impact of disease on family and community life. Results The primary outcome data was available for 32 (64%) participants in the intervention arm, and 38 (76%) participants in control arm. The treatment was significantly more successful in the intervention arm (p<0.03). The data on secondary outcomes was available for all participants. Stigma due to disease was significantly lower in the intervention arm (p<0.01); also rejection faced by participants from family and community due to disease was significantly lower among the HC group (p<0.05). Conclusion Home-based care in MDR TB treatment holds potential in improving treatment outcomes of patient. PMID:28969162

Home Based Care as an Approach to Improve the Efficiency of treatment for MDR Tuberculosis: A Quasi-Experimental Pilot Study.

PubMed

Taneja, Neha; Chellaiyan, Vinoth Gnana; Daral, Shailaja; Adhikary, Mrinmoy; Das, Timiresh Kumar

2017-08-01

Multi Drug Resistant Tuberculosis (MDR TB) has emerged as a significant public health problem in India. The prolonged treatment duration in MDR TB is a challenge in achieving treatment completion and poses a threat to TB control in the country. Home based care is an approach accepted by patients because it helps in ameliorating their understanding of TB, improving the compliance and reducing stigma in the community. To assess the outcome of Home-Based Care (HC) versus No Home-Based Care (NHC) on the treatment of MDR TB patients registered at two chest clinics in Eastern Delhi. A quasi-experimental study was done among diagnosed MDR TB patients receiving Category IV regimen under Revised National Tuberculosis Control Programme (RNTCP) from two government chest clinics in Eastern Delhi during May 2014 to May 2016. In the control arm, 50 MDR TB patients at one of the chest clinics were offered the standard Category IV regimen under RNTCP; while in the intervention arm, 50 MDR TB patients at the second chest clinic were provided home based care (counselling, support for completion of treatment, rehabilitation, and nutritional support) along with the standard treatment. The primary outcome assessed was outcome of treatment, while secondary outcomes included stigma faced due to the disease, and impact of disease on family and community life. The primary outcome data was available for 32 (64%) participants in the intervention arm, and 38 (76%) participants in control arm. The treatment was significantly more successful in the intervention arm (p<0.03). The data on secondary outcomes was available for all participants. Stigma due to disease was significantly lower in the intervention arm (p<0.01); also rejection faced by participants from family and community due to disease was significantly lower among the HC group (p<0.05). Home-based care in MDR TB treatment holds potential in improving treatment outcomes of patient.

Comparison of visual evoked potential monitoring during spine surgeries under total intravenous anesthesia versus balanced general anesthesia.

PubMed

Uribe, Alberto A; Mendel, Ehud; Peters, Zoe A; Shneker, Bassel F; Abdel-Rasoul, Mahmoud; Bergese, Sergio D

2017-10-01

To determine the comparison of its clinical utility and safety profile for visual evoked potential (VEP) monitoring during prone spine surgeries under total intravenous anesthesia (TIVA) versus balanced general anesthesia using the SightSaver™ visual stimulator. The protocol was designed asa pilot, single center, prospective, randomized, and double-arm study. Subjects were randomized to receive either TIVA or balanced general anesthesia. Following induction and intubation, 8 electrodes were placed subcutaneously to collect VEP recordings. The SightSaver™ visual stimulator was placed on the subject's scalp before prone positioning. VEP waveforms were recorded every 30min and assessed by a neurophysiologist throughout the length of surgery. A total of 19 subjects were evaluated and VEP waveforms were successfully collected. TIVA group showed higher amplitude and lower latency than balanced anesthesia. Our data suggested that TIVA is associated with higher VEP amplitude and shorter latencies than balanced general anesthesia; therefore, TIVA could be the most efficient anesthesia regimen for VEP monitoring. The findings help to better understand the effect of different anesthesia regimens on intra-operative VEP monitoring. Copyright © 2017 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.

Transdiagnostic and Transcultural: Pilot Study of Unified Protocol for Depressive and Anxiety Disorders in Japan.

PubMed

Ito, Masaya; Horikoshi, Masaru; Kato, Noriko; Oe, Yuki; Fujisato, Hiroko; Nakajima, Shun; Kanie, Ayako; Miyamae, Mitsuhiro; Takebayashi, Yoshitake; Horita, Ryo; Usuki, Masato; Nakagawa, Atsuo; Ono, Yutaka

2016-05-01

Unified protocol (UP) is a transdiagnostic cognitive behavior therapy for emotional disorders. It remains unknown whether UP is applicable for use in non-Western countries and for depressive disorders. We therefore examined its feasibility for a Japanese clinical population using this clinical trial design, which is multicentered, open-labeled, and single-armed (Clinical registry: UMIN000008322). The primary outcome was severity of anxiety symptoms, as assessed using Structured Interview Guide for the Hamilton Anxiety Rating Scale. Secondary outcomes were depressive symptoms, clinical global impression, functioning, quality of life, affectivity, emotion regulation, and adverse events. Of the 28 prospective participants, 17 were eligible and enrolled (depressive disorders=9, anxiety disorders=8). Severity of anxiety symptoms, which decreased significantly after the intervention, remained low for 3months (Hedges' g=1.29, 95% CI=0.56-2.06). Similar tendencies were observed for secondary outcome measures. No severe adverse event occurred. Two participants dropped out of the intervention. High treatment adherence and interrater reliability were confirmed. Results suggest the feasibility of UP in the Japanese context sufficient to warrant a larger clinical trial. Copyright © 2016. Published by Elsevier Ltd.

A RANDOMIZED TREATMENT TRIAL: SINGLE VERSUS 7 DAY DOSE OF METRONIDAZOLE FOR THE TREATMENT OF TRICHOMONAS VAGINALIS AMONG HIV-INFECTED WOMEN

PubMed Central

Kissinger, Patricia; Mena, Leandro; Levison, Judy; Clark, Rebecca A.; Gatski, Megan; Henderson, Harold; Schmidt, Norine; Rosenthal, Susan; Myers, Leann; Martin, David H.

2010-01-01

Objective To determine if the metronidazole (MTZ) 2 gm single dose (recommended) is as effective as the 7 day 500 mg BID dose (alternative) for treatment of Trichomonas vaginalis (TV) among HIV+ women. Methods Phase IV randomized clinical trial; HIV+ women with culture confirmed TV were randomized to treatment arm: MTZ 2 gm single dose or MTZ 500 mg BID 7 day dose. All women were given 2 gm MTZ doses to deliver to their sex partners. Women were re-cultured for TV at a test-of-cure (TOC) visit occurring 6-12 days after treatment completion. TV-negative women at TOC were again re-cultured at a 3 month visit. Repeat TV infection rates were compared between arms. Results 270 HIV+/TV+ women were enrolled (mean age = 40 years, ± 9.4; 92.2% African-American). Treatment arms were similar with respect to age, race, CD4 count, viral load, ART status, site, and loss-to-follow up. Women in the 7 day arm had: lower repeat TV infection rates at TOC [8.5% (11/130) versus 16.8% (21/125) (R.R. 0.50, 95% CI=0.25, 1.00; P<0.05)], and at 3 months [11.0% (8/73) versus 24.1% (19/79) (R.R. 0.46, 95% CI=0.21, 0.98; P=0.03)] compared to the single dose arm. Conclusions The 7 day MTZ dose was more effective than the single dose for the treatment of TV among HIV+ women. PMID:21423852

Analysis of nevirapine (NVP) resistance in Ugandan infants who were HIV infected despite receiving single-Dose (SD) NVP versus SD NVP plus daily NVP up to 6 weeks of age to prevent HIV vertical transmission.

PubMed

Church, Jessica D; Omer, Saad B; Guay, Laura A; Huang, Wei; Lidstrom, Jessica; Musoke, Philippa; Mmiro, Francis; Jackson, J Brooks; Eshleman, Susan H

2008-10-01

Single-dose nevirapine (SD NVP) at birth plus NVP prophylaxis for the infant up to 6 weeks of age is superior to SD NVP alone for prevention of vertical transmission of human immunodeficiency virus (HIV) through breastfeeding. We analyzed NVP resistance in HIV-infected Ugandan infants who received either SD NVP or extended NVP prophylaxis. We tested plasma HIV by using a genotyping assay (ViroSeq; Celera Diagnostics), a phenotypic resistance assay (PhenoSense; Monogram Biosciences), and sensitive point mutation assay (LigAmp, for K103N, Y181C, and G190A). When infants were 6 weeks old, ViroSeq detected NVP resistance in a higher proportion of infants in the extended NVP arm than in the SD NVP arm (21 of 25 [84%] vs. 12 of 24 [50%]; P = .01). Similar results were obtained with LigAmp and PhenoSense. In both study arms, infants who were HIV infected at birth frequently had NVP resistance detected. In contrast, infants in the extended NVP arm who were HIV infected after birth were more likely to have resistance detected at 6 weeks, compared with infants in the SD NVP arm. The use of extended NVP prophylaxis was also associated with detection of NVP resistance by ViroSeq at 6 months (7 of 7 [100%] infants in the extended NVP arm had resistance detected, compared with 1 of 6 [16.7%] infants in the SD NVP arm; P = .005). The use of extended NVP prophylaxis was associated with increased selection for and persistence of NVP resistance in HIV-infected Ugandan infants.

On-chip beamsplitter operation on single photons from quasi-resonantly excited quantum dots embedded in GaAs rib waveguides

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

Rengstl, U.; Schwartz, M.; Herzog, T.

2015-07-13

We present an on-chip beamsplitter operating on a single-photon level by means of a quasi-resonantly driven InGaAs/GaAs quantum dot. The single photons are guided by rib waveguides and split into two arms by an evanescent field coupler. Although the waveguides themselves support the fundamental TE and TM modes, the measured degree of polarization (∼90%) reveals the main excitation and propagation of the TE mode. We observe the preserved single-photon nature of a quasi-resonantly excited quantum dot by performing a cross-correlation measurement on the two output arms of the beamsplitter. Additionally, the same quantum dot is investigated under resonant excitation, wheremore » the same splitting ratio is observed. An autocorrelation measurement with an off-chip beamsplitter on a single output arm reveal the single-photon nature after evanescent coupling inside the on-chip splitter. Due to their robustness, adjustable splitting ratio, and their easy implementation, rib waveguide beamsplitters with embedded quantum dots provide a promising step towards fully integrated quantum circuits.« less

Acute effects of vibration from a chipping hammer and a grinder on the hand-arm system.

PubMed Central

Kihlberg, S; Attebrant, M; Gemne, G; Kjellberg, A

1995-01-01

OBJECTIVES--The purpose of this study was to compare various effects on the hand-arm system of vibration exposure from a chipping hammer and a grinder with the same frequency weighted acceleration. Grip and push forces were measured and monitored during the exposure. The various effects were: muscle activity (measured with surface electrodes), discomfort ratings for different parts of the hand-arm system (made during and after exposure), and vibration perception threshold (for 10 minutes before and 10 minutes after the exposure). RESULTS--No increase in muscle activity due to exposure to vibration was found in the hand muscle studied. In the forearm, conversely, there was an increase in both muscle studied. For the upper arm the muscle activity only increased when exposed to impact vibration. Subjective ratings in the hand and shift in vibration perception threshold were effected more by the grinder than the hammer exposure. CONCLUSION--These results show that the reaction of the hand-arm system to vibration varies with frequency quantitatively as well as qualitatively. They do not support the notion that one single frequency weighted curve would be valid for the different health effects of hand-arm vibration (vascular, musculoskeletal, neurological, and psychophysiological). PMID:8535492

Biomechanically Induced and Controller Coupled Oscillations Experienced on the F-16XL Aircraft During Rolling Maneuvers

NASA Technical Reports Server (NTRS)

Smith, John W.; Montgomery, Terry

1996-01-01

During rapid rolling maneuvers, the F-16 XL aircraft exhibits a 2.5 Hz lightly damped roll oscillation, perceived and described as 'roll ratcheting.' This phenomenon is common with fly-by-wire control systems, particularly when primary control is derived through a pedestal-mounted side-arm controller. Analytical studies have been conducted to model the nature of the integrated control characteristics. The analytical results complement the flight observations. A three-degree-of-freedom linearized set of aerodynamic matrices was assembled to simulate the aircraft plant. The lateral-directional control system was modeled as a linear system. A combination of two second-order transfer functions was derived to couple the lateral acceleration feed through effect of the operator's arm and controller to the roll stick force input. From the combined systems, open-loop frequency responses and a time history were derived, describing and predicting an analogous in-flight situation. This report describes the primary control, aircraft angular rate, and position time responses of the F-16 XL-2 aircraft during subsonic and high-dynamic-pressure rolling maneuvers. The analytical description of the pilot's arm and controller can be applied to other aircraft or simulations to assess roll ratcheting susceptibility.

Predicting the language proficiency of Chinese student pilots within American airspace: Single-task versus dual-task English-language assessment

NASA Astrophysics Data System (ADS)

Noble, Clifford Elliott, II

2002-09-01

The problem. The purpose of this study was to investigate the ability of three single-task instruments---(a) the Test of English as a Foreign Language, (b) the Aviation Test of Spoken English, and (c) the Single Manual-Tracking Test---and three dual-task instruments---(a) the Concurrent Manual-Tracking and Communication Test, (b) the Certified Flight Instructor's Test, and (c) the Simulation-Based English Test---to predict the language performance of 10 Chinese student pilots speaking English as a second language when operating single-engine and multiengine aircraft within American airspace. Method. This research implemented a correlational design to investigate the ability of the six described instruments to predict the mean score of the criterion evaluation, which was the Examiner's Test. This test assessed the oral communication skill of student pilots on the flight portion of the terminal checkride in the Piper Cadet, Piper Seminole, and Beechcraft King Air airplanes. Results. Data from the Single Manual-Tracking Test, as well as the Concurrent Manual-Tracking and Communication Test, were discarded due to performance ceiling effects. Hypothesis 1, which stated that the average correlation between the mean scores of the dual-task evaluations and that of the Examiner's Test would predict the mean score of the criterion evaluation with a greater degree of accuracy than that of single-task evaluations, was not supported. Hypothesis 2, which stated that the correlation between the mean scores of the participants on the Simulation-Based English Test and the Examiner's Test would predict the mean score of the criterion evaluation with a greater degree of accuracy than that of all single- and dual-task evaluations, was also not supported. The findings suggest that single- and dual-task assessments administered after initial flight training are equivalent predictors of language performance when piloting single-engine and multiengine aircraft.

Multicolour versus monocolour inking specimens after pancreaticoduodenectomy for periampullary cancer: A single centre prospective randomised clinical trial.

PubMed

Casadei, Riccardo; Ricci, Claudio; Taffurelli, Giovanni; Pacilio, Carlo Alberto; Santini, Donatella; Di Marco, Mariacristina; Minni, Francesco

2018-03-01

R status represents an important prognostic factors in periampullary cancers. Thus, it is useful to verify if it can be influenced by different techniques of margination. Single-centre, randomised clinical trial of patients affected by periampullary cancer who underwent pancreaticoduodenectomies which included two different types of margination: arm A (multicolour inking) and arm B (monocolour inking). The primary endpoint was the overall R1 resection rate and its difference between the two arms. The secondary endpoints were the R1 resection rate in each margin and its difference between the two arms, and the impact of margin status on survival. Fifty patients were randomised, 41 analysed: 22 in arm A, 19 arm B. The overall R1 status was 61%, without significant differences between the two arms. The margin most commonly involved was the superior mesenteric artery (SMA) (36.6%). A trend in favour of arm B was shown for the superior mesenteric artery margin (arm A = 22.7% versus arm B = 52.6%; P = 0.060). The anterior surface (P = 0.015), SMA (P = 0.047) and pancreatic remnant (P = 0.018) margins significantly influenced disease-free survival. The R status was not influenced by different techniques of margination using a standardised pathological protocol. The SMA margin seemed to be the most important margin for evaluating both R status and disease-free survival. Copyright © 2018. Published by Elsevier Ltd.

Cognitive rehabiliation for Parkinson's disease demantia: a study protocol for a pilot randomised controlled trial.

PubMed

Hindle, John V; Watermeyer, Tamlyn J; Roberts, Julie; Martyr, Anthony; Lloyd-Williams, Huw; Brand, Andrew; Gutting, Petra; Hoare, Zoe; Edwards, Rhiannon Tudor; Clare, Linda

2016-03-22

There is growing interest in developing non-pharmacological treatments to address the cognitive deficits apparent in Parkinson's disease dementia and dementia with Lewy bodies. Cognitive rehabilitation is a goal-oriented behavioural intervention which focuses on improving everyday functioning through management of cognitive difficulties; it has been shown to be effective in Alzheimer's disease. To date, no studies have assessed its potential efficacy for addressing the impact of cognitive impairment in people with Parkinson's disease or dementia with Lewy bodies. Participants (n = 45) will be recruited from movement disorders, care for the elderly and memory clinics. Inclusion criteria include: a diagnosis of Parkinson's disease, Parkinson's disease dementia or dementia with Lewy bodies according to consensus criteria and an Addenbrooke's Cognitive Examination - III score of ≤ 82. Exclusion criteria include: a diagnosis of any other significant neurological condition; major psychiatric disorder, including depression, which is not related to the patient's Parkinson's disease and unstable medication use for their physical or cognitive symptoms. A single-blind pilot randomised controlled trial, with concurrent economic evaluation, will compare the relative efficacy of cognitive rehabilitation with that of two control conditions. Following a goal-setting interview, the participants will be randomised to one of the three study arms: cognitive rehabilitation (eight weekly sessions), relaxation therapy (eight weekly sessions) or treatment as usual. Randomisation and treatment group allocation will be carried out by a clinical trials unit using a dynamic adaptive sequential randomisation algorithm. The primary outcomes are patients' perceived goal attainment at a 2-months post-intervention assessment and a 6-months follow-up. Secondary outcomes include patients' objective cognitive performance (on tests of memory and executive function) and satisfaction with goal attainment, carers' perception of patients' goal attainment and patients' and carers' health status and psychosocial well-being, measured at the same time points. Cost-effectiveness will be examined to explore the design of a larger cost-effectiveness analysis alongside a full trial. This pilot study will evaluate the application of cognitive rehabilitation for the management of cognitive difficulties associated with Parkinson's disease dementia and dementia with Lewy bodies. The results of the study will inform the design of a fully powered randomised controlled trial. ISRCTN16584442 DOI 10.1186/ISRCTN16584442 13 April 2015.

A pilot study on the effects of individually tailored education for MMR vaccine-hesitant parents on MMR vaccination intention

PubMed Central

Gowda, Charitha; Schaffer, Sarah E.; Kopec, Kristin; Markel, Arielle; Dempsey, Amanda F.

2013-01-01

Healthcare providers need strategies to better address the concerns of vaccine-hesitant parents. We studied whether individually tailored education was more effective than untailored education at improving vaccination intention among MMR vaccine-hesitant parents. In an intervention pilot study of parents (n = 77) of children < 6 y who screened as hesitant to vaccinate against MMR (first or second dose), parents were randomly assigned to receive either (1) educational web pages that were individually tailored to address their specific vaccine concerns; or (2) web pages similar in appearance to the intervention but containing untailored information. The main outcome, change in vaccination intention before and after the intervention, was assessed using an 11-pt scale (higher values indicated greater intent). We found that a greater proportion of parents in the tailored than untailored arm had positive vaccination intentions after viewing educational information (58% vs. 46%). Furthermore, parents in the tailored group had a greater magnitude of change in vaccination intention (1.08 vs. 0.49 points) than participants in the untailored group. However, neither of these results was statistically significant. From this pilot study we conclude message tailoring may be an effective way to improve vaccine compliance among vaccine hesitant parents. However, larger studies are warranted to further investigate the efficacy of providing tailored education for increasing vaccine acceptance among parents with diverse beliefs. PMID:23291937

Results of a Pilot Study to Ameliorate Psychological and Behavioral Outcomes of Minority Stress Among Young Gay and Bisexual Men.

PubMed

Smith, Nathan Grant; Hart, Trevor A; Kidwai, Ammaar; Vernon, Julia R G; Blais, Martin; Adam, Barry

2017-09-01

Project PRIDE (Promoting Resilience In Discriminatory Environments) is an 8-session small group intervention aimed at reducing negative mental and behavioral health outcomes resulting from minority stress. This study reports the results of a one-armed pilot test of Project PRIDE, which aimed to examine the feasibility and potential for efficacy of the intervention in a sample of 33 gay and bisexual men aged 18 to 25. The intervention appeared feasible to administer in two different sites and all participants who completed posttreatment (n = 22) or follow-up (n = 19) assessments reported high satisfaction with the intervention. Small to large effect sizes were observed for increases in self-esteem; small effect sizes were found for decreases in loneliness and decreases in minority stress variables; and small and medium effect sizes were found for reductions in alcohol use and number of sex partners, respectively. Overall, Project PRIDE appears to be a feasible intervention with promise of efficacy. Copyright © 2017. Published by Elsevier Ltd.

The Mobile Insulin Titration Intervention (MITI) for Insulin Adjustment in an Urban, Low-Income Population: Randomized Controlled Trial.

PubMed

Levy, Natalie; Moynihan, Victoria; Nilo, Annielyn; Singer, Karyn; Bernik, Lidia S; Etiebet, Mary-Ann; Fang, Yixin; Cho, James; Natarajan, Sundar

2015-07-17

Diabetes patients are usually started on a low dose of insulin and their dose is adjusted or "titrated" according to their blood glucose levels. Insulin titration administered through face-to-face visits with a clinician can be time consuming and logistically burdensome for patients, especially those of low socioeconomic status (SES). Given the wide use of mobile phones among this population, there is the potential to use short message service (SMS) text messaging and phone calls to perform insulin titration remotely. The goals of this pilot study were to (1) evaluate if our Mobile Insulin Titration Intervention (MITI) intervention using text messaging and phone calls was effective in helping patients reach their optimal insulin glargine dose within 12 weeks, (2) assess the feasibility of the intervention within our clinic setting and patient population, (3) collect data on the cost savings associated with the intervention, and (4) measure patient satisfaction with the intervention. This was a pilot study evaluating an intervention for patients requiring insulin glargine titration in the outpatient medical clinic of Bellevue Hospital Center in New York City. Patients in the intervention arm received weekday SMS text messages from a health management platform requesting their fasting blood glucose values. The clinic's diabetes nurse educator monitored the texted responses on the platform website each weekday for alarm values. Once a week, the nurse reviewed the glucose values, consulted the MITI titration algorithm, and called patients to adjust their insulin dose. Patients in the usual care arm continued to receive their standard clinic care for insulin titration. The primary outcome was whether a patient reached his/her optimal insulin glargine dose within 12 weeks. A total of 61 patients consented and were randomized into the study. A significantly greater proportion of patients in the intervention arm reached their optimal insulin glargine dose than patients in the usual care arm (88%, 29/33 vs 37%, 10/27; P<.001). Patients responded to 84.3% (420/498) of the SMS text messages requesting their blood glucose values. The nurse reached patients within 2 attempts or by voicemail 91% of the time (90/99 assigned calls). When patients traveled to the clinic, they spent a median of 45 minutes (IQR 30-60) on travel and 39 minutes (IQR 30-64) waiting prior to appointments. A total of 61% (37/61) of patients had appointment copays. After participating in the study, patients in the intervention arm reported higher treatment satisfaction than those in the usual care arm. MITI is an effective way to help low-SES patients reach their optimal insulin glargine dose using basic SMS text messaging and phone calls. The intervention was feasible and patients were highly satisfied with their treatment. The intervention was cost saving in terms of time for patients, who were able to have their insulin titrated without multiple clinic appointments. Similar interventions should be explored to improve care for low-SES patients managing chronic disease. Clinicaltrials.gov NCT01879579; https://clinicaltrials.gov/ct2/show/NCT01879579 (Archived by WebCite at http://www.webcitation.org/6YZik33L3).

Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST): rationale, design, and protocol of a pilot randomized clinical trial assessing the Wii gaming system.

PubMed

Saposnik, G; Mamdani, M; Bayley, M; Thorpe, K E; Hall, J; Cohen, L G; Teasell, R

2010-02-01

Evidence suggests that increasing intensity of rehabilitation results in better motor recovery. Limited evidence is available on the effectiveness of an interactive virtual reality gaming system for stroke rehabilitation. EVREST was designed to evaluate feasibility, safety and efficacy of using the Nintendo Wii gaming virtual reality (VRWii) technology to improve arm recovery in stroke patients. Pilot randomized study comparing, VRWii versus recreational therapy (RT) in patients receiving standard rehabilitation within six months of stroke with a motor deficit of > or =3 on the Chedoke-McMaster Scale (arm). In this study we expect to randomize 20 patients. All participants (age 18-85) will receive customary rehabilitative treatment consistent of a standardized protocol (eight sessions, 60 min each, over a two-week period). The primary feasibility outcome is the total time receiving the intervention. The primary safety outcome is the proportion of patients experiencing intervention-related adverse events during the study period. Efficacy, a secondary outcome measure, will be measured by the Wolf Motor Function Test, Box and Block Test, and Stroke Impact Scale at the four-week follow-up visit. From November, 2008 to September, 2009 21 patients were randomized to VRWii or RT. Mean age, 61 (range 41-83) years. Mean time from stroke onset 25 (range 10-56) days. EVREST is the first randomized parallel controlled trial assessing the feasibility, safety, and efficacy of virtual reality using Wii gaming technology in stroke rehabilitation. The results of this study will serve as the basis for a larger multicentre trial. ClinicalTrials.gov registration# NTC692523.

Combined Clinic-Home Approach for Upper Limb Robotic Therapy After Stroke: A Pilot Study.

PubMed

Kim, Grace J; Rivera, Lisa; Stein, Joel

2015-12-01

To investigate the feasibility of a combined clinic-home intervention using a robotic elbow brace and, secondarily, to collect preliminary data on the efficacy of this clinic-home intervention. Nonrandomized pre-/postinterventional study. Outpatient clinic and participants' homes. Individuals at least 6 months after stroke (N=11; 5 women and 6 men; mean age, 51.7y; mean time since stroke, 7.6y; mean Fugl-Meyer Assessment of the Upper Extremity [FMA-UE] score, 22 of 66) were enrolled from the community. Participants received training in an outpatient clinic from an experienced occupational therapist to gain independence with use of the device (3-9 sessions) followed by a 6-week home program using the device at home. Five instruments were administered before and after the study intervention: Modified Ashworth Scale, Box and Blocks test, FMA-UE, Arm Motor Ability Test, and Motor Activity Log-Amount of Use and Motor Activity Log-How Well subscales (MAL-AOU, MAL-HW). Nine participants completed the study. Participants used the device on average 42.9min/d, 5.3d/wk. The FMA-UE (t=3.32; P=.01), MAL-AOU (t=4.40; P=.002), and MAL-HW (t=4.02; P=.004) scores showed statistically significant improvement from baseline to discharge; the MAL-AOU (t=2.61; P=.035) and MAL-HW (t=2.47; P=.043) scores were also significantly improved from baseline to 3-month follow-up. This combined clinic-home intervention was feasible and effective. Participants demonstrated improvements in arm impairment and self-reported use of the arm from baseline to discharge; they continued to report significant improvement in actual use of the arm at 3-month follow-up. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Manned Systems Utilization Analysis. Study 2.1: Space Servicing Pilot Program Study. [for automated payloads

NASA Technical Reports Server (NTRS)

Wolfe, R. R.

1975-01-01

Space servicing automated payloads was studied for potential cost benefits for future payload operations. Background information is provided on space servicing in general, and on a pilot flight test program in particular. An fight test is recommended to demonstrate space servicing. An overall program plan is provided which builds upon the pilot program through an interim servicing capability. A multipayload servicing concept for the time when the full capability tug becomes operational is presented. The space test program is specifically designed to provide low-cost booster vehicles and a flight test platform for several experiments on a single flight.

Feasibility of tuberculosis treatment monitoring by video directly observed therapy: a binational pilot study.

PubMed

Garfein, R S; Collins, K; Muñoz, F; Moser, K; Cerecer-Callu, P; Raab, F; Rios, P; Flick, A; Zúñiga, M L; Cuevas-Mota, J; Liang, K; Rangel, G; Burgos, J L; Rodwell, T C; Patrick, K

2015-09-01

Although directly observed therapy (DOT) is recommended worldwide for monitoring anti-tuberculosis treatment, transportation and personnel requirements limit its use. To evaluate the feasibility and acceptability of 'video DOT' (VDOT), which allows patients to record and transmit medication ingestion via videos watched remotely by health care providers to document adherence. We conducted a single-arm trial among tuberculosis (TB) patients in San Diego, California, USA, (n = 43) and Tijuana, Mexico (n = 9) to represent high- and low-resource settings. Pre-/post-treatment interviews assessed participant characteristics and experiences. Adherence was defined as the proportion of observed doses to expected doses. The mean age was 37 years (range 18-86), 50% were male, and 88% were non-Caucasian. The mean duration of VDOT use was 5.5 months (range 1-11). Adherence was similar in San Diego (93%) and Tijuana (96%). Compared to time on in-person DOT, 92% preferred VDOT, 81% thought VDOT was more confidential, 89% never/rarely had problems recording videos, and 100% would recommend VDOT to others. Seven (13%) participants were returned to in-person DOT and six (12%) additional participants had their phones lost, broken or stolen. VDOT was feasible and acceptable, with high adherence in both high- and low-resource settings. Efficacy and cost-effectiveness studies are needed.

Pilot study of Internet-based early intervention for combat-related mental distress.

PubMed

Van Voorhees, Benjamin W; Gollan, Jackie; Fogel, Joshua

2012-01-01

This article evaluates an Internet-based early intervention combining online cognitive-behavioral therapy (CBT) with electronic peer-to-peer support intended to promote mental health and well-being among combat veterans. We conducted a phase 1 clinical trial of 50 Iraq and Afghanistan veterans using a pre and post single-arm design. We evaluated feasibility and changes in mental health symptoms (depression and posttraumatic stress disorder [PTSD]), functional status, and attitudes toward treatment seeking at baseline and weeks 4, 8, and 12. A diverse group of veterans was enrolled (26% ethnic minority, 90% male, 66% with income <$30,000/year, 88% with no prior treatment for depression). Participants completed a mean of 4 of 6 lessons (standard deviation = 2.54). From baseline to week 12, there were significant declines in the Center for Epidemiologic Studies-Depression scale score (effect size [ES] = 0.41) and PTSD Checklist-Military version score (ES = 0.53). There were significant improvements in willingness to accept diagnosis (ES = 1.08) and perceived social norms and stigma regarding friends (ES = 1.51). Although lack of a control group is a limitation, the Internet-based program combining CBT-based coping skills training and peer-to-peer support demonstrated potential feasibility and evidenced benefit in symptom remediation for depression and PTSD.

Use of virtual reality to promote hand therapy post-stroke

NASA Astrophysics Data System (ADS)

Tsoupikova, Daria; Stoykov, Nikolay; Vick, Randy; Li, Yu; Kamper, Derek; Listenberger, Molly

2013-03-01

A novel artistic virtual reality (VR) environment was developed and tested for use as a rehabilitation protocol for post-stroke hand rehabilitation therapy. The system was developed by an interdisciplinary team of engineers, art therapists, occupational therapists, and VR artists to improve patients' motivation and engagement. Specific exercises were developed to explicitly promote the practice of therapeutic tasks requiring hand and arm coordination for upper extremity rehabilitation. Here we describe system design, development, and user testing for efficiency, subject's satisfaction and clinical feasibility. We report results of the completed qualitative, pre-clinical pilot study of the system effectiveness for therapy. Fourteen stroke survivors with chronic hemiparesis participated in a single training session within the environment to gauge user response to the protocol through a custom survey. Results indicate that users found the system comfortable, enjoyable, tiring; instructions clear, and reported a high level of satisfaction with the VR environment and rehabilitation task variety and difficulty. Most patients reported very positive impressions of the VR environment and rated it highly, appreciating its engagement and motivation. We are currently conducting a longitudinal intervention study over 6 weeks in stroke survivors with chronic hemiparesis. Initial results following use of the system on the first subjects demonstrate that the system is operational and can facilitate therapy for post stroke patients with upper extremity impairment.

Single-pilot workload management in entry-level jets.

DOT National Transportation Integrated Search

2013-09-01

Researchers from the NASA Ames Flight Cognition Lab and the FAAs Flight Deck Human Factors Research Laboratory at the Civil Aerospace Medical Institute (CAMI) examined task and workload management by single pilots in Very Light Jets (VLJs), also c...

Arm and wrist surface potential mapping for wearable ECG rhythm recording devices: a pilot clinical study

NASA Astrophysics Data System (ADS)

Lynn, W. D.; Escalona, O. J.; McEneaney, D. J.

2013-06-01

This study addresses an important question in the development of a ECG device that enables long term monitoring of cardiac rhythm. This device would utilise edge sensor technologies for dry, non-irritant skin contact suitable for distal limb application and would be supported by embedded ECG denoising processes. Contemporary ECG databases including those provided by MIT-BIH and Physionet are focused on interpretation of cardiac disease and rhythm tracking. The data is recorded using chest leads as in standard clinical practise. For the development of a peripherally located heart rhythm monitor, such data would be of limited use. To provide a useful database adequate for the development of the above mentioned cardiac monitoring device a unipolar body surface potential map from the left arm and wrist was gathered in 37 volunteer patients and characterized in this study. For this, the reference electrode was placed at the wrist. Bipolar far-field electrogram leads were derived and analysed. Factors such as skin variability, 50Hz noise interference, electrode contact noise, motion artifacts and electromyographic noise, presented a challenge. The objective was quantify the signal-to-noise ratio (SNR) at the far-field locations. Preliminary results reveal that an electrogram indicative of the QRS complex can be recorded on the distal portion of the left arm when denoised using signal averaging techniques.

Is Single Gender Schooling Viable in the Public Sector? Lessons from Californias Pilot Program. Final Report.

ERIC Educational Resources Information Center

Datnow, Amanda; Hubbard, Lea; Woody, Elisabeth

In 1997, California became the first state to conduct large-scale experimentation with single gender public education. This longitudinal study examined the impact of single gender academies in six California districts, focusing on equity implications. Data from observations and interviews with educators, policymakers, and students indicated that…

Analysis of reaching movements of upper arm in robot assisted exercises. Kinematic assessment of robot assisted upper arm reaching single-joint movements.

PubMed

Iuppariello, Luigi; D'Addio, Giovanni; Romano, Maria; Bifulco, Paolo; Lanzillo, Bernardo; Pappone, Nicola; Cesarelli, Mario

2016-01-01

Robot-mediated therapy (RMT) has been a very dynamic area of research in recent years. Robotics devices are in fact capable to quantify the performances of a rehabilitation task in treatments of several disorders of the arm and the shoulder of various central and peripheral etiology. Different systems for robot-aided neuro-rehabilitation are available for upper limb rehabilitation but the biomechanical parameters proposed until today, to evaluate the quality of the movement, are related to the specific robot used and to the type of exercise performed. Besides, none study indicated a standardized quantitative evaluation of robot assisted upper arm reaching movements, so the RMT is still far to be considered a standardised tool. In this paper a quantitative kinematic assessment of robot assisted upper arm reaching movements, considering also the effect of gravity on the quality of the movements, is proposed. We studied a group of 10 healthy subjects and results indicate that our advised protocol can be useful for characterising normal pattern in reaching movements.

Assessing the Feasibility of a Social Media to Promote Weight Management Engagement in Adolescents with Severe Obesity: Pilot Study

PubMed Central

Moore, Reneé H; Li, Ziyi; Bishop-Gilyard, Chanelle T; Garrett, Andrew R; Hill, Douglas L; Bruton, Yasmeen P; Sarwer, David B

2018-01-01

Background Severe obesity in adolescents has deleterious physical and psychological complications necessitating frequent multi-disciplinary clinic visits. Greater treatment engagement has been equated with weight-loss. However, traditional medical weight-loss programs for adolescents have high attrition rates. Social media is widely used by adolescents and may enhance medical weight management engagement and success. Objective The first objective was to examine the acceptability and feasibility of using a private social media group as an adjunct to medical weight management in youth ages 14 to 20 years with severe obesity [body mass index (BMI) ≥ 35 kg/m2]. The second objective was to pilot test the use of social media to improve treatment engagement and decrease attrition rates. Methods In this single arm, 12 week pre-post study, participants attended individual clinic visits and participated in a moderated private social media group that received nutrition, exercise, and behavior change social media communications or “posts” 3 to 4 times/week. Youth commented and/or liked posts from the moderator and each other. Social media engagement was measured with the number of likes and comments on social media. Clinic attrition was compared, measuring clinic visit attendance 12 weeks prior, during, and after the intervention with mixed linear regression models. Correlations of social media engagement with changes from baseline for BMI, BMI-z score, and psychosocial measures were fit. Results All 13 enrolled youth completed the study and reported that the group was enjoyable, helpful, reinforced their weight management program, and would recommend using social media to support other youth. The pilot trial was acceptable and feasible. Youth mean weekly engagement (likes + comments) in social media was greater than once a day (8.6 ±3.6). Compared to 12 weeks prior to the intervention, there was no significant decrease in clinic visit attendance at the end of the intervention (M=.231, P=.69) or 12 weeks at the conclusion of the intervention (M=.589, P=.28). Increased social media comments correlated with weight change (r=–.633, P=.04). Conclusions This pilot trial demonstrated that the use of social media as an adjunct to medical weight management was feasible and acceptable to adolescents with severe obesity. Based upon these preliminary findings, social media may be an effective way to mitigate attrition from obesity treatment programs, and improve health outcomes in this high-risk population. PMID:29555623

Head and facial anthropometry of mixed-race US Army male soldiers for military design and sizing: a pilot study.

PubMed

Yokota, Miyo

2005-05-01

In the United States, the biologically admixed population is increasing. Such demographic changes may affect the distribution of anthropometric characteristics, which are incorporated into the design of equipment and clothing for the US Army and other large organizations. The purpose of this study was to examine multivariate craniofacial anthropometric distributions between biologically admixed male populations and single racial groups of Black and White males. Multivariate statistical results suggested that nose breadth and lip length were different between Blacks and Whites. Such differences may be considered for adjustments to respirators and chemical-biological protective masks. However, based on this pilot study, multivariate anthropometric distributions of admixed individuals were within the distributions of single racial groups. Based on the sample reported, sizing and designing for the admixed groups are not necessary if anthropometric distributions of single racial groups comprising admixed groups are known.

Gender Differences in Cardiovascular Tolerance to Short Arm Centrifugation

NASA Technical Reports Server (NTRS)

Fong, Kevin J.; Arya, Maneesh; Paloski, William H.

2007-01-01

In preparation for the NASA Artificial Gravity (AG) pilot study, the tolerability of the proposed AG parameters was tested in 11 ambulatory human subjects (6m, 5w) by exposing each to a short arm centrifuge trial. Subjects were oriented in the supine position (but inclined 6deg head down) on one arm of the centrifuge, and the rotation rate (30.6-33.4 rpm) and radial position of the feet were set to produce 2.5G of equivalent gravitational load at the force plate directly beneath the feet, 1G at the level of the mediastinum, and approximately 0.55G at the labyrinth. Amongst the 6 men participating in this preliminary study, 5 completed at least 60 minutes of the trial successfully with no adverse sequelae. However, amongst the female cohort the test was stopped by the medical monitor before 60 min in all but one case, with pre-syncope listed as the reason for termination in all cases. Mean time before abort of the centrifuge run amongst the women was 33.2 +/- 20.97 min. It is known that women have a greater predisposition to syncope during orthostatic stress, under normal tilt table conditions, during LBNP, and following space flight. The reasons for this difference are the subject of some debate, but anthropometric factors, the vasoactive effects of sex hormones, gender differences in susceptibility to motion sickness, catecholamine levels, ability to augment total peripheral resistance in response to orthostatic stress, and structural differences in cardiac anatomy and physiology have all been suggested. This finding led to the exclusion of women from the AG pilot study. Clearly if AG is to be employed as a multi-system countermeasure it must provide physiological protection at rotation rates within the tolerance limits of all potential astronauts. Further investigation of the responses of women to centrifugation will be necessary to determine how to adjust AG parameters for tolerance by female subjects before a more detailed investigation of the appropriate dose in terms of G load, rotation rate, exposure duration and frequency can be performed.

76 FR 17936 - Federal Housing Administration (FHA): Notice of FHA PowerSaver Home Energy Retrofit Loan Pilot...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-31

... Housing Administration (FHA): Notice of FHA PowerSaver Home Energy Retrofit Loan Pilot Program AGENCY...: Notice. SUMMARY: This notice announces HUD's FHA Home Energy Retrofit Loan Pilot Program (Retrofit Pilot... to conduct an Energy Efficient Mortgage Innovation pilot program targeted to the single family...

Classification of response-types for single-pilot NOE helicopter combat tasks

NASA Technical Reports Server (NTRS)

Mitchell, David G.; Hoh, Roger H.; Atencio, Adolph, Jr.

1987-01-01

Two piloted simulations have recently been conducted to evaluate both workload and handling qualities requirements for operation of a helicopter by a single pilot in a nap-of-the-earth combat environment. An advanced cockpit, including a moving-map display and an interactive touchpad screen, provided aircraft mission, status, and position information to the pilot. The results of the simulations are reviewed, and the impact of these results on the development of a revised helicopter handling qualities specification is discussed. Rate command is preferred over attitude command in pitch and roll, and attitude hold over groundspeed hold, for low-speed precision pointing tasks. Position hold is necessary for Level 1 handling qualities in hover when the pilot is required to perform secondary tasks. Addition of a second crew member improves pilot ratings.

Evaluation of a single column model at the Southern Great Plains climate research facility

NASA Astrophysics Data System (ADS)

Kennedy, Aaron D.

Despite recent advancements in global climate modeling, models produce a large range of climate sensitivities for the Earth. This range of sensitivities results in part from uncertainties in modeling clouds. To understand and to improve cloud parameterizations in Global Climate Models (GCMs), simulations should be evaluated using observations of clouds. Detailed studies can be conducted at Atmospheric Radiation Measurements (ARM) sites which provide adequate observations and forcing for Single Column Model (SCM) studies. Unfortunately, forcing for SCMs is sparse and not available for many locations or times. This study had two main goals: (1) evaluate clouds from the GISS Model E AR5 SCM at the ARM Southern Great Plains site and (2) determine whether reanalysis-based forcing was feasible at this location. To accomplish these goals, multiple model runs were conducted from 1999--2008 using forcing provided by ARM and forcing developed from the North American Regional Reanalysis (NARR). To better understand cloud biases and differences in the forcings, atmospheric states were classified using Self Organizing Maps (SOMs). Although model simulations had many similarities with the observations, there were several noticeable biases. Deep clouds had a negative bias year-round and this was attributed to clouds being too thin during frontal systems and a lack of convection during the spring and summer. These results were consistent regardless of the forcing used. During August, SCM simulations had a positive bias for low clouds. This bias varied with the forcing suggesting that part of the problem was tied to errors in the forcing. NARR forcing had many favorable characteristics when compared to ARM observations and forcing. In particular, temperature and wind information were more accurate than ARM when compared to balloon soundings. During the cool season, NARR forcing produced results similar to ARM with reasonable precipitation and a similar cloud field. Although NARR vertical velocities were weaker than ARM during the convective season, these simulations were able to capture the majority of convective events. The limiting factor for NARR was humidity biases in the upper troposphere during the summer months. Prior to releasing this forcing to the modeling community, this issue must be investigated further.

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.

Diversity Initiatives in Higher Education: Intergroup Dialogue as Pedagogy across the Curriculum

ERIC Educational Resources Information Center

Clark, Christine

2005-01-01

The idea for the Intergroup Dialogue as Pedagogy Across the Curriculum (INTERACT) Pilot Project emerged, quite organically, from the cross-pollination of two major initiatives of the Office of Human Relations Programs (OHRP), the equity compliance and multicultural education arm of the Office of the President at the University of Maryland, College…

Brain SPECT scans in students with specific learning disability: Preliminary results.

PubMed

Karande, S; Deshmukh, N; Rangarajan, V; Agrawal, A; Sholapurwala, R

2018-06-08

Brain single-photon emission computed tomography (SPECT) assesses brain function through measurement of regional cerebral blood flow. This study was conducted to assess whether students with newly diagnosed specific learning disability (SpLD) show any abnormalities in cerebral cortex perfusion. Cross-sectional single-arm pilot study in two tertiary care hospitals. Nine students with SpLD were enrolled. Brain SPECT scan was done twice in each student. For the first or "baseline" scan, the student was first made to sit with eyes open in a quiet, dimly lit room for a period of 30-40 min and then injected intravenously with 20 mCi of 99mTc-ECD. An hour later, "baseline scan" was conducted. After a minimum gap of 4 days, a second or "test scan" was conducted, wherein the student performed an age-appropriate curriculum-based test for a period of 30-40 min to activate the areas in central nervous system related to learning before being injected with 20 mCi of 99mTc-ECD. Cerebral cortex perfusion at rest and after activation in each student was compared qualitatively by visual analysis and quantitatively using NeuroGam TM software. Visual analysis showed reduction in regional blood flow in temporoparietal areas in both "baseline" and "test" scans. However, when normalization was attempted and comparison done by Talairach analysis using NeuroGam software, no statistically significant change in regional perfusion in temporoparietal areas was appreciated. Brain SPECT scan may serve as a robust tool to identify changes in regional brain perfusion in students with SpLD.

Providing Home-Based HIV Testing and Counseling for Transgender Youth (Project Moxie): Protocol for a Pilot Randomized Controlled Trial.

PubMed

Stephenson, Rob; Metheny, Nicholas; Sharma, Akshay; Sullivan, Stephen; Riley, Erin

2017-11-28

Transgender and gender nonconforming people experience some of the highest human immunodeficiency virus (HIV) rates in the United States, and experience many structural and behavioral barriers that may limit their engagement in HIV testing, prevention, and care. Evidence suggests that transgender and gender nonconforming youth (TY) are especially vulnerable to acquiring HIV, yet there is little research on TY and few services are targeted towards HIV testing, prevention, and care for this population. Telehealth presents an opportunity to mitigate some structural barriers that TY experience in accessing HIV testing, allowing TY to engage in HIV testing and counseling in a safe and nonjudgmental space of their choosing. Project Moxie is an HIV prevention intervention that pairs the use of HIV self-testing with remote video-based counseling and support from a trained, gender-affirming counselor. This study aims to offer a more positive HIV testing and counseling experience, with the goal of improving HIV testing frequency. Project Moxie involves a pilot randomized controlled trial (RCT) of 200 TY aged 15-24 years, who are randomized on a 1:1 basis to control or intervention arms. The aim is to examine whether the addition of counseling provided via telehealth, coupled with home-based HIV testing, can create gains in routine HIV testing among TY over a six-month follow-up period. This study implements a prospective pilot RCT of 200 TY recruited online. Participants in the control arm will receive one HIV self-testing kit and will be asked to report their results via the study's website. Participants in the experimental arm will receive one HIV self-testing kit and will test with a remotely-located counselor during a prescheduled video-counseling session. Participants are assessed at baseline, and at three and six months posttesting. Project Moxie was launched in June 2017 and recruitment is ongoing. As of August 21, 2017, the study had enrolled 130 eligible participants. Combining home-based HIV testing and video-based counseling allows TY, an often stigmatized and marginalized population, to test for HIV in a safe and nonjudgmental setting of their choosing. This approach creates an opportunity to reduce the high rate of HIV among TY through engagement in care, support, and linkage to the HIV treatment cascade for those who test positive. ClinicalTrials.gov NCT03185975; https://clinicaltrials.gov/ct2/show/NCT03185975 (Archived by WebCite at http://www.webcitation.org/6vIjHJ93s). ©Rob Stephenson, Nicholas Metheny, Akshay Sharma, Stephen Sullivan, Erin Riley. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 28.11.2017.

Single-pilot workload management in entry-level jets : appendices.

DOT National Transportation Integrated Search

2013-09-01

Researchers from the NASA Ames Flight Cognition Lab and the FAAs Flight Deck Human Factors Research Laboratory at the Civil Aerospace Medical Institute (CAMI) examined task and workload management by single pilots in Very Light Jets (VLJs), also c...

Association of N-acetyltransferase-2 and glutathione S-transferase polymorphisms with idiopathic male infertility in Vietnam male subjects.

PubMed

Trang, Nguyen Thi; Huyen, Vu Thi; Tuan, Nguyen Thanh; Phan, Tran Duc

2018-04-25

N-acetyltransferase-2 (NAT2) and Glutathione S-transferases (GSTs) are phase-II xenobiotic metabolizing enzymes participating in detoxification of toxic arylamines, aromatic amines, hydrazines and reactive oxygen species (ROS), which are produced under oxidative and electrophile stresses. The purpose of this research was to investigate whether two common single-nucleotide polymorphisms (SNP) of NAT2 (rs1799929, rs1799930) and GSTP1 (rs1138272, rs1695) associated with susceptibility to idiopathic male infertility. A total 300 DNA samples (150 infertile patients and 150 healthy control) were genotyped for the polymorphisms by ARMS - PCR. We revealed a significant association between the NAT2 variant genotypes (CT + TT (rs1799929), (OR: 3.74; p < 0.001)) and (GA + AA (rs1799930), (OR: 3.75; p < 0.001)) or GSTP1 variant genotypes (GA + AA (rs1695), (OR: 5.11; p < 0,001)) and (CT + TT (rs1138272), (OR: 7.42; p < 0,001) with idiopathic infertility risk. Our findings rate the effect of single-nucleotide polymorphisms of GSTP1 and/or NAT2 in modulation of the risk of male infertility in subjects from Vietnam. This pilot study is the first (as far as we know) to reveal that polymorphisms of NAT2 (rs1799929, rs1799930) and GSTP1 (rs1138272, rs1695) are some novel genetic markers for susceptibility to idiopathic male infertility. Copyright © 2018 Elsevier B.V. All rights reserved.

Rapid impact testing for quantitative assessment of large populations of bridges

NASA Astrophysics Data System (ADS)

Zhou, Yun; Prader, John; DeVitis, John; Deal, Adrienne; Zhang, Jian; Moon, Franklin; Aktan, A. Emin

2011-04-01

Although the widely acknowledged shortcomings of visual inspection have fueled significant advances in the areas of non-destructive evaluation and structural health monitoring (SHM) over the last several decades, the actual practice of bridge assessment has remained largely unchanged. The authors believe the lack of adoption, especially of SHM technologies, is related to the 'single structure' scenarios that drive most research. To overcome this, the authors have developed a concept for a rapid single-input, multiple-output (SIMO) impact testing device that will be capable of capturing modal parameters and estimating flexibility/deflection basins of common highway bridges during routine inspections. The device is composed of a trailer-mounted impact source (capable of delivering a 50 kip impact) and retractable sensor arms, and will be controlled by an automated data acquisition, processing and modal parameter estimation software. The research presented in this paper covers (a) the theoretical basis for SISO, SIMO and MIMO impact testing to estimate flexibility, (b) proof of concept numerical studies using a finite element model, and (c) a pilot implementation on an operating highway bridge. Results indicate that the proposed approach can estimate modal flexibility within a few percent of static flexibility; however, the estimated modal flexibility matrix is only reliable for the substructures associated with the various SIMO tests. To overcome this shortcoming, a modal 'stitching' approach for substructure integration to estimate the full Eigen vector matrix is developed, and preliminary results of these methods are also presented.

Safety of a single low-dose of primaquine in addition to standard artemether-lumefantrine regimen for treatment of acute uncomplicated Plasmodium falciparum malaria in Tanzania.

PubMed

Mwaiswelo, Richard; Ngasala, Billy E; Jovel, Irina; Gosling, Roland; Premji, Zul; Poirot, Eugenie; Mmbando, Bruno P; Björkman, Anders; Mårtensson, Andreas

2016-06-10

This study assessed the safety of the new World Health Organization (WHO) recommendation of adding a single low-dose of primaquine (PQ) to standard artemisinin-based combination therapy (ACT), regardless of individual glucose-6-phosphate dehydrogenase (G6PD) status, for treatment of acute uncomplicated Plasmodium falciparum malaria in Tanzania. Men and non-pregnant, non-lactating women aged ≥1 year with uncomplicated P. falciparum malaria were enrolled and randomized to either standard artemether-lumefantrine (AL) regimen alone or with a 0.25 mg/kg single-dose of PQ. PQ was administered concomitantly with the first AL dose. All drug doses were supervised. Safety was evaluated between days 0 and 28. G6PD status was assessed using rapid test (CareStart™) and molecular genotyping. The primary endpoint was mean percentage relative reduction in haemoglobin (Hb) concentration (g/dL) between days 0 and 7 by genotypic G6PD status and treatment arm. Overall, 220 patients, 110 per treatment arm, were enrolled, of whom 33/217 (15.2 %) were phenotypically G6PD deficient, whereas 15/110 (13.6 %) were genotypically hemizygous males, 5/110 (4.5 %) homozygous females and 22/110 (20 %) heterozygous females. Compared to genotypically G6PD wild-type/normal [6.8, 95 % confidence interval (CI) 4.67-8.96], only heterozygous patients in AL arm had significant reduction in day-7 mean relative Hb concentration (14.3, 95 % CI 7.02-21.55, p=0.045), however, none fulfilled the pre-defined haemolytic threshold value of ≥25 % Hb reduction. After adjustment for baseline parasitaemia, Hb, age and sex the mean relative Hb reduction was not statistically significant in both heterozygous and hemizygous/homozygous patients in both arms. A majority of the adverse events (AEs) were mild and unrelated to the study drugs. However, six (4.4 %) episodes, three per treatment arm, of acute haemolytic anaemia occurred between days 0 and 7. Three occurred in phenotypically G6PD deficient patients, two in AL and one in AL + PQ arm, but none in genotypically hemizygous/homozygous patients. All patients with acute haemolytic anaemia recovered without medical intervention. The findings support that the WHO recommendation of adding a single low-dose of PQ to standard AL regimen is safe for the treatment of acute uncomplicated P. falciparum malaria regardless of G6PD status in Tanzania. Trial registration number NCT02090036.

A comparison of Kneipp hydrotherapy with conventional physiotherapy in the treatment of osteoarthritis: a pilot trial.

PubMed

Schencking, Martin; Wilm, Stefan; Redaelli, Marcus

2013-01-01

An increasingly aging population implies an increasing prevalence of osteoarthritis (OA) of hip or knee. It has been ascertained that unspecific hydrotherapy of OA according to Sebastian Kneipp not only improves the range of mobility but also reduces pain significantly and increases the quality of life of the patients affected. The main aim of this pilot study was to determine the effects of hydrotherapy in comparison to conventional physiotherapy, and to analyze the feasibility of the study design under clinical circumstances. The study design is a prospective randomized controlled three-arm clinical pilot trial, carried out at a specialist clinic for integrative medicine. Thirty patients diagnosed with symptomatic OA of hip or knee and radiologic findings were randomly assigned to one of two intervention groups and a control group: hydrotherapy (group 1), physiotherapy (group 2), and both physiotherapy and hydrotherapy (group 3, control group) of the affected joint. pain intensity of the affected joint in the course of inpatient treatment; secondary outcome: health-related quality of life, joint-specific pain and mobility in the course of the study. Concerning the main outcome, intervention group 1 showed most beneficial effects in the course of inpatient treatment, followed by groups 3 and 2, and also the indirect flexion ability of hip or knee together with the general patient mobility through the "timed up and go" test were mainly improved within group 1 followed by groups 3 and 2. The results of this pilot study demonstrate beneficial effects of hydrotherapy. The study design is feasible. For statistically significant evidence and a robust conclusion of efficacy of Kneipp's hydrotherapy, a larger sample size is necessary. NCT 00950326.

Wii-Fit for Improving Gait and Balance in an Assisted Living Facility: A Pilot Study

PubMed Central

Padala, Kalpana P.; Padala, Prasad R.; Malloy, Timothy R.; Geske, Jenenne A.; Dubbert, Patricia M.; Dennis, Richard A.; Garner, Kimberly K.; Bopp, Melinda M.; Burke, William J.; Sullivan, Dennis H.

2012-01-01

Objectives. To determine the effects on balance and gait of a Wii-Fit program compared to a walking program in subjects with mild Alzheimer's dementia (AD). Methods. A prospective randomized (1 : 1) pilot study with two intervention arms was conducted in an assisted living facility with twenty-two mild AD subjects. In both groups the intervention occurred under supervision for 30 minutes daily, five times a week for eight weeks. Repeated measures ANOVA and paired t-tests were used to analyze changes. Results. Both groups showed improvement in Berg Balance Scale (BBS), Tinetti Test (TT) and Timed Up and Go (TUG) over 8 weeks. However, there was no statistically significant difference between the groups over time. Intragroup analysis in the Wii-Fit group showed significant improvement on BBS (P = 0.003), and TT (P = 0.013). The walking group showed a trend towards improvement on BBS (P = 0.06) and TUG (P = 0.07) and significant improvement in TT (P = 0.06). Conclusion. This pilot study demonstrates the safety and efficacy of Wii-Fit in an assisted living facility in subjects with mild AD. Use of Wii-Fit resulted in significant improvements in balance and gait comparable to those in the robust monitored walking program. These results need to be confirmed in a larger, methodologically sound study. PMID:22745909

Modeling human pilot cue utilization with applications to simulator fidelity assessment.

PubMed

Zeyada, Y; Hess, R A

2000-01-01

An analytical investigation to model the manner in which pilots perceive and utilize visual, proprioceptive, and vestibular cues in a ground-based flight simulator was undertaken. Data from a NASA Ames Research Center vertical motion simulator study of a simple, single-degree-of-freedom rotorcraft bob-up/down maneuver were employed in the investigation. The study was part of a larger research effort that has the creation of a methodology for determining flight simulator fidelity requirements as its ultimate goal. The study utilized a closed-loop feedback structure of the pilot/simulator system that included the pilot, the cockpit inceptor, the dynamics of the simulated vehicle, and the motion system. With the exception of time delays that accrued in visual scene production in the simulator, visual scene effects were not included in this study. Pilot/vehicle analysis and fuzzy-inference identification were employed to study the changes in fidelity that occurred as the characteristics of the motion system were varied over five configurations. The data from three of the five pilots who participated in the experimental study were analyzed in the fuzzy-inference identification. Results indicate that both the analytical pilot/vehicle analysis and the fuzzy-inference identification can be used to identify changes in simulator fidelity for the task examined.

Prospective Pilot Study of the Mastering Each New Direction Psychosocial Family Systems Program for Pediatric Chronic Illness.

PubMed

Distelberg, Brian; Tapanes, Daniel; Emerson, Natacha D; Brown, Whitney N; Vaswani, Deepti; Williams-Reade, Jackie; Anspikian, Ara M; Montgomery, Susanne

2018-03-01

Psychosocial interventions for pediatric chronic illness (CI) have been shown to support health management. Interventions that include a family systems approach offer potentially stronger and more sustainable improvements. This study explores the biopsychosocial benefits of a novel family systems psychosocial intervention (MEND: Mastering Each New Direction). Forty-five families participated in a 21-session intensive outpatient family systems-based program for pediatric CI. Within this single arm design, families were measured on five domains of Health-Related Quality of Life (HRQL) self-report measures; Stress, Cognitive Functioning, Mental Health, Child HRQL, Family Functioning. Both survey and biological measures (stress: catecholamine) were used in the study. Results from multivariate general linear models showed positive pre-, post-, and 3-month posteffects in all five domains. The program effects ranged from small to moderate (η 2  = .07-.64). The largest program effects were seen in the domains of cognitive functioning (η 2  = .64) and stress (η 2  = .27). Also, between disease groups, differences are noted and future implications for research and clinical practice are discussed. Conclusions suggest that the MEND program may be useful in helping families manage pediatric chronic illnesses. Study results also add to the growing body of literature suggesting that psychosocial interventions for pediatric chronic illness benefit from a family systems level of intervention. © 2017 Family Process Institute.

Interaction between Antagonist of Cannabinoid Receptor and Antagonist of Adrenergic Receptor on Anxiety in Male Rat.

PubMed

Komaki, Alireza; Abdollahzadeh, Fatemeh; Sarihi, Abdolrahman; Shahidi, Siamak; Salehi, Iraj

2014-01-01

Anxiety is among the most common and treatable mental disorders. Adrenergic and cannabinoid systems have an important role in the neurobiology of anxiety. The elevated plus-maze (EPM) has broadly been used to investigate anxiolytic and anxiogenic compounds. The present study investigated the effects of intraperitoneal (IP) injection of cannabinoid CB1 receptor antagonist (AM251) in the presence of alpha-1 adrenergic antagonist (Prazosin) on rat behavior in the EPM. In this study, the data were obtained from male Wistar rat, which weighing 200- 250 g. Animal behavior in EPM were videotaped and saved in computer for 10 min after IP injection of saline, AM251 (0.3 mg/kg), Prazosin (0.3 mg/kg) and AM251 + Prazosin, subsequently scored for conventional indices of anxiety. During the test period, the number of open and closed arms entries, the percentage of entries into the open arms of the EPM, and the spent time in open and closed arms were recorded. Diazepam was considered as a positive control drug with anxiolytic effect (0.3, 0.6, 1.2 mg/kg). Diazepam increased the number of open arm entries and the percentage of spent time on the open arms. IP injection of AM251 before EPM trial decreased open arms exploration and open arm entry. Whereas, Prazosin increased open arms exploration and open arm entry. This study showed that both substances in simultaneous injection have conflicting effects on the responses of each of these two compounds in a single injection. Injection of CB1 receptor antagonist may have an anxiogenic profile in rat, whereas adrenergic antagonist has an anxiolytic effect. Further investigations are essential for better understanding of anxiolytic and anxiogenic properties and neurobiological mechanisms of action and probable interactions of the two systems.

Single pilot IFR operating problems determined from accidental data analysis

NASA Technical Reports Server (NTRS)

Forsyth, D. L.; Shaughnessy, J. D.

1978-01-01

The accident reports examined were restricted to instrument rated pilots flying in IFR weather. A brief examination was made of accidents which occurred during all phases of flight and which were due to all causes. A detailed examination was made of those accidents which involved a single pilot which occurred during the landing phases of flight, and were due to pilot error. Problem areas found include: (1) landing phase operations especially final approach, (2) pilot weather briefings, (3) night approaches in low IFR weather, (4) below minimum approaches, (5) aircraft icing, (6) imprecise navigation, (7) descending below minimum IFR altitudes, (8) fuel mismanagement, (9) pilot overconfidence, and (10) high pilot workload especially in twins. Some suggested areas of research included: (1) low cost deicing systems, (2) standardized navigation displays, (3) low cost low-altitude warning systems, (4) improved fuel management systems, (5) improved ATC communications, (6) more effective pilot training and experience acquisition methods, and (7) better weather data dissemination techniques.

Using shape to turn off blinking for two-colour multiexciton emission in CdSe/CdS tetrapods

NASA Astrophysics Data System (ADS)

Mishra, Nimai; Orfield, Noah J.; Wang, Feng; Hu, Zhongjian; Krishnamurthy, Sachidananda; Malko, Anton V.; Casson, Joanna L.; Htoon, Han; Sykora, Milan; Hollingsworth, Jennifer A.

2017-05-01

Semiconductor nanostructures capable of emitting from two excited states and thereby of producing two photoluminescence colours are of fundamental and potential technological significance. In this limited class of nanocrystals, CdSe/CdS core/arm tetrapods exhibit the unusual trait of two-colour (red and green) multiexcitonic emission, with green emission from the CdS arms emerging only at high excitation fluences. Here we show that by synthetic shape-tuning, both this multi-colour emission process, and blinking and photobleaching behaviours of single tetrapods can be controlled. Specifically, we find that the properties of dual emission and single-nanostructure photostability depend on different structural parameters--arm length and arm diameter, respectively--but that both properties can be realized in the same nanostructure. Furthermore, based on results of correlated photoluminescence and transient absorption measurements, we conclude that hole-trap filling in the arms and partial state-filling in the core are necessary preconditions for the observation of multiexciton multi-colour emission.

Beam rider for an Articulated Robot Manipulator (ARM) accurate positioning of long flexible manipulators

NASA Technical Reports Server (NTRS)

Malachowski, M. J.

1990-01-01

Laser beam positioning and beam rider modules were incorporated into the long hollow flexible segment of an articulated robot manipulator (ARM). Using a single laser beam, the system determined the position of the distal ARM endtip, with millimetric precision, in six degrees of freedom, at distances of up to 10 meters. Preliminary designs, using space rated technology for the critical systems, of a two segmented physical ARM, with a single and a dual degree of freedom articulation, were developed, prototyped, and tested. To control the positioning of the physical ARM, an indirect adaptive controller, which used the mismatch between the position of the laser beam under static and dynamic conditions, was devised. To predict the behavior of the system and test the concept, a computer simulation model was constructed. A hierarchical artificially intelligent real time ADA operating system program structure was created. The software was designed for implementation on a dedicated VME bus based Intel 80386 administered parallel processing multi-tasking computer system.

Using shape to turn off blinking for two-colour multiexciton emission in CdSe/CdS tetrapods

PubMed Central

Mishra, Nimai; Orfield, Noah J.; Wang, Feng; Hu, Zhongjian; Krishnamurthy, Sachidananda; Malko, Anton V.; Casson, Joanna L.; Htoon, Han; Sykora, Milan; Hollingsworth, Jennifer A.

2017-01-01

Semiconductor nanostructures capable of emitting from two excited states and thereby of producing two photoluminescence colours are of fundamental and potential technological significance. In this limited class of nanocrystals, CdSe/CdS core/arm tetrapods exhibit the unusual trait of two-colour (red and green) multiexcitonic emission, with green emission from the CdS arms emerging only at high excitation fluences. Here we show that by synthetic shape-tuning, both this multi-colour emission process, and blinking and photobleaching behaviours of single tetrapods can be controlled. Specifically, we find that the properties of dual emission and single-nanostructure photostability depend on different structural parameters—arm length and arm diameter, respectively—but that both properties can be realized in the same nanostructure. Furthermore, based on results of correlated photoluminescence and transient absorption measurements, we conclude that hole-trap filling in the arms and partial state-filling in the core are necessary preconditions for the observation of multiexciton multi-colour emission. PMID:28497776

Identification and Expression of Acetylcholinesterase in Octopus vulgaris Arm Development and Regeneration: a Conserved Role for ACHE?

PubMed

Fossati, Sara Maria; Candiani, Simona; Nödl, Marie-Therese; Maragliano, Luca; Pennuto, Maria; Domingues, Pedro; Benfenati, Fabio; Pestarino, Mario; Zullo, Letizia

2015-08-01

Acetylcholinesterase (ACHE) is a glycoprotein with a key role in terminating synaptic transmission in cholinergic neurons of both vertebrates and invertebrates. ACHE is also involved in the regulation of cell growth and morphogenesis during embryogenesis and regeneration acting through its non-cholinergic sites. The mollusk Octopus vulgaris provides a powerful model for investigating the mechanisms underlying tissue morphogenesis due to its high regenerative power. Here, we performed a comparative investigation of arm morphogenesis during adult arm regeneration and embryonic arm development which may provide insights on the conserved ACHE pathways. In this study, we cloned and characterized O. vulgaris ACHE, finding a single highly conserved ACHE hydrophobic variant, characterized by prototypical catalytic sites and a putative consensus region for a glycosylphosphatidylinositol (GPI)-anchor attachment at the COOH-terminus. We then show that its expression level is correlated to the stage of morphogenesis in both adult and embryonic arm. In particular, ACHE is localized in typical neuronal sites when adult-like arm morphology is established and in differentiating cell locations during the early stages of arm morphogenesis. This possibility is also supported by the presence in the ACHE sequence and model structure of both cholinergic and non-cholinergic sites. This study provides insights into ACHE conserved roles during processes of arm morphogenesis. In addition, our modeling study offers a solid basis for predicting the interaction of the ACHE domains with pharmacological blockers for in vivo investigations. We therefore suggest ACHE as a target for the regulation of tissue morphogenesis.

The Influences of Arm Resist Motion on a CAR Crash Test Using Hybrid III Dummy with Human-Like Arm

NASA Astrophysics Data System (ADS)

Kim, Yongchul; Youm, Youngil; Bae, Hanil; Choi, Hyeonki

Safety of the occupant during the crash is very essential design element. Many researches have been investigated in reducing the fatal injury of occupant. They are focusing on the development of a dummy in order to obtain the real human-like motion. However, they have not considered the arm resist motion during the car accident. In this study, we would like to suggest the importance of the reactive force of the arm in a car crash. The influences of reactive force acting on the human upper extremity were investigated using the impedance experimental method with lumped mass model of hand system and a Hybrid III dummy with human-like arm. Impedance parameters (e.g. inertia, spring constant and damping coefficient) of the elbow joint in maximum activation level were measured by free oscillation test using single axis robot. The results showed that without seat belt, the reactive force of human arm reduced the head, chest, and femur injury, and the flexion moment of the neck is higher than that of the conventional dummy.

Physical ACtivity facilitation for Elders (PACE): study protocol for a randomised controlled trial.

PubMed

Morgan, Gemma S; Haase, Anne M; Campbell, Rona; Ben-Shlomo, Yoav

2015-03-13

As people live longer, their risk of disability increases. Disability affects quality of life and increases health and social care costs. Preventing or delaying disability is therefore an important objective, and identifying an effective intervention could improve the lives of many older people. Observational and interventional evidence suggests that physical activity may reduce the risk of age-related disability, as assessed by physical performance measures. However it is unclear what approach is the most cost-effective intervention in changing long-term physical activity behaviour in older adults. A new theory-driven behavioural intervention has been developed, with the aim of increasing physical activity in the everyday lives of older adults at risk of disability. This pilot study tests the feasibility and acceptability of delivering this intervention to older adults. A randomised controlled trial (RCT) design will be used in the pilot study. Sixty patients aged 65 years and older will be recruited from primary care practices. Patients will be eligible to participate if they are inactive, not disabled at baseline, are at risk of developing disability in the future (Short Physical Performance Battery score <10/12), and have no contraindications to physical activity. Following baseline measures, participants will be randomised in a 2:1 ratio to the intervention or to a control arm and all participants will be followed-up after 6 months. Those randomised to the intervention arm will receive sessions with a trained Physical Activity Facilitator, delivering an intervention based on self-determination theory. Control participants receive a booklet on healthy ageing. The main outcomes of interest are recruitment, adherence, retention and acceptability. Data will also be collected on: self-report and accelerometer-recorded physical activity; physical performance; depression; wellbeing; cognitive function; social support; quality of life, healthcare use, and attitudes to physical activity. A mixed-methods process evaluation will run alongside the RCT. The intervention, if effective, has the potential to reduce disability and improve quality of life in older adults. Before proceeding to a full-scale trial a pilot trial is necessary to ensure intervention feasibility and acceptability, and that the intervention shows evidence of promise. Current Controlled Trials ISRCTN80470273 . Registered 25 October 2013.

Combining destination diversion decisions and critical in-flight event diagnosis in computer aided testing of pilots

NASA Technical Reports Server (NTRS)

Rockwell, T. H.; Giffin, W. C.; Romer, D. J.

1984-01-01

Rockwell and Giffin (1982) and Giffin and Rockwell (1983) have discussed the use of computer aided testing (CAT) in the study of pilot response to critical in-flight events. The present investigation represents an extension of these earlier studies. In testing pilot responses to critical in-flight events, use is made of a Plato-touch CRT system operating on a menu based format. In connection with the typical diagnostic problem, the pilot was presented with symptoms within a flight scenario. In one problem, the pilot has four minutes for obtaining the information which is needed to make a diagnosis of the problem. In the reported research, the attempt has been made to combine both diagnosis and diversion scenario into a single computer aided test. Tests with nine subjects were conducted. The obtained results and their significance are discussed.