Protective effects of Tualang honey on bone structure in experimental postmenopausal rats

PubMed Central

Zaid, Siti Sarah Mohamad; Sulaiman, Siti Amrah; Othman, Nor Hayati; Soelaiman, Ima-Nirwana; Shuid, Ahmad Nazrun; Mohamad, Norazlina; Muhamad, Norliza

2012-01-01

OBJECTIVE: The objective of this study was to evaluate the effects of Tualang honey on trabecular structure and compare these effects with those of calcium supplementation in ovariectomized rats. METHODS: Forty female, Sprague-Dawley rats were randomly divided into five groups (n = 8): four controls and one test arm. The control arm comprised a baseline control, sham-operated control, ovariectomized control, and ovariectomized calcium-treated rats (receiving 1% calcium in drinking water ad libitum). The test arm was composed of ovariectomized, Tualang honey-treated rats (received 0.2 g/kg body weight of Tualang honey). Both the sham-operated control and ovariectomized control groups received vehicle treatment (deionized water), and the baseline control group was sacrificed without treatment. RESULTS: All rats were orally gavaged daily for six weeks after day one post-surgery. The bone structural analysis of rats in the test arm group showed a significant increase in the bone volume per tissue volume (BV/TV), trabecular thickness (Tb.Th) and trabecular number (Tb.N) and a significant decrease in inter-trabecular space (Tb.Sp) compared with the ovariectomized control group. The trabecular thickness (Tb.Th) in the test arm group was significantly higher compared with the ovariectomized-calcium treated group, and the inter-trabecular space (Tb.Sp) in the test arm group was significantly narrower compared with the ovariectomized-calcium treated group. CONCLUSION: In conclusion, ovariectomized rats that received Tualang honey showed more improvements in trabecular bone structure than the rats that received calcium. PMID:22892923

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

Load emphasizes muscle effort minimization during selection of arm movement direction

PubMed Central

2012-01-01

Background Directional preferences during center-out horizontal shoulder-elbow movements were previously established for both the dominant and non-dominant arm with the use of a free-stroke drawing task that required random selection of movement directions. While the preferred directions were mirror-symmetrical in both arms, they were attributed to a tendency specific for the dominant arm to simplify control of interaction torque by actively accelerating one joint and producing largely passive motion at the other joint. No conclusive evidence has been obtained in support of muscle effort minimization as a contributing factor to the directional preferences. Here, we tested whether distal load changes directional preferences, making the influence of muscle effort minimization on the selection of movement direction more apparent. Methods The free-stroke drawing task was performed by the dominant and non-dominant arm with no load and with 0.454 kg load at the wrist. Motion of each arm was limited to rotation of the shoulder and elbow in the horizontal plane. Directional histograms of strokes produced by the fingertip were calculated to assess directional preferences in each arm and load condition. Possible causes for directional preferences were further investigated by studying optimization across directions of a number of cost functions. Results Preferences in both arms to move in the diagonal directions were revealed. The previously suggested tendency to actively accelerate one joint and produce passive motion at the other joint was supported in both arms and load conditions. However, the load increased the tendency to produce strokes in the transverse diagonal directions (perpendicular to the forearm orientation) in both arms. Increases in required muscle effort caused by the load suggested that the higher frequency of movements in the transverse directions represented increased influence of muscle effort minimization on the selection of movement direction. This interpretation was supported by cost function optimization results. Conclusions While without load, the contribution of muscle effort minimization was minor, and therefore, not apparent, the load revealed this contribution by enhancing it. Unlike control of interaction torque, the revealed tendency to minimize muscle effort was independent of arm dominance. PMID:23035925

Randomized Phase III Clinical Trial of Five Different Arms of Treatment in 332 Patients with Cancer Cachexia

PubMed Central

Macciò, Antonio; Madeddu, Clelia; Serpe, Roberto; Massa, Elena; Dessì, Mariele; Panzone, Filomena; Contu, Paolo

2010-01-01

Purpose. A phase III, randomized study was carried out to establish the most effective and safest treatment to improve the primary endpoints of cancer cachexia—lean body mass (LBM), resting energy expenditure (REE), and fatigue—and relevant secondary endpoints: appetite, quality of life, grip strength, Glasgow Prognostic Score (GPS) and proinflammatory cytokines. Patients and Methods. Three hundred thirty-two assessable patients with cancer-related anorexia/cachexia syndrome were randomly assigned to one of five treatment arms: arm 1, medroxyprogesterone (500 mg/day) or megestrol acetate (320 mg/day); arm 2, oral supplementation with eicosapentaenoic acid; arm 3, L-carnitine (4 g/day); arm 4, thalidomide (200 mg/day); and arm 5, a combination of the above. Treatment duration was 4 months. Results. Analysis of variance showed a significant difference between treatment arms. A post hoc analysis showed the superiority of arm 5 over the others for all primary endpoints. An analysis of changes from baseline showed that LBM (by dual-energy X-ray absorptiometry and by L3 computed tomography) significantly increased in arm 5. REE decreased significantly and fatigue improved significantly in arm 5. Appetite increased significantly in arm 5; interleukin (IL)-6 decreased significantly in arm 5 and arm 4; GPS and Eastern Cooperative Oncology Group performance status (ECOG PS) score decreased significantly in arm 5, arm 4, and arm 3. Toxicity was quite negligible, and was comparable between arms. Conclusion. The most effective treatment in terms of all three primary efficacy endpoints and the secondary endpoints appetite, IL-6, GPS, and ECOG PS score was the combination regimen that included all selected agents. PMID:20156909

A method for removing arm backscatter from EPID images

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

King, Brian W.; Greer, Peter B.; School of Mathematical and Physical Sciences, University of Newcastle, Newcastle, New South Wales 2308

2013-07-15

Purpose: To develop a method for removing the support arm backscatter from images acquired using current Varian electronic portal imaging devices (EPIDs).Methods: The effect of arm backscatter on EPID images was modeled using a kernel convolution method. The parameters of the model were optimized by comparing on-arm images to off-arm images. The model was used to develop a method to remove the effect of backscatter from measured EPID images. The performance of the backscatter removal method was tested by comparing backscatter corrected on-arm images to measured off-arm images for 17 rectangular fields of different sizes and locations on the imager.more » The method was also tested using on- and off-arm images from 42 intensity modulated radiotherapy (IMRT) fields.Results: Images generated by the backscatter removal method gave consistently better agreement with off-arm images than images without backscatter correction. For the 17 rectangular fields studied, the root mean square difference of in-plane profiles compared to off-arm profiles was reduced from 1.19% (standard deviation 0.59%) on average without backscatter removal to 0.38% (standard deviation 0.18%) when using the backscatter removal method. When comparing to the off-arm images from the 42 IMRT fields, the mean {gamma} and percentage of pixels with {gamma} < 1 were improved by the backscatter removal method in all but one of the images studied. The mean {gamma} value (1%, 1 mm) for the IMRT fields studied was reduced from 0.80 to 0.57 by using the backscatter removal method, while the mean {gamma} pass rate was increased from 72.2% to 84.6%.Conclusions: A backscatter removal method has been developed to estimate the image acquired by the EPID without any arm backscatter from an image acquired in the presence of arm backscatter. The method has been shown to produce consistently reliable results for a wide range of field sizes and jaw configurations.« less

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

PubMed Central

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

2015-01-01

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

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

Inter-arm blood pressure difference in type 2 diabetes: a barrier to effective management?

PubMed Central

Clark, Christopher E; Greaves, Colin J; Evans, Philip H; Dickens, Andy; Campbell, John L

2009-01-01

Background Previous studies have identified a substantial prevalence of a blood pressure difference between arms in various populations, but not patients with type 2 diabetes. Recognition of such a difference would be important as a potential cause of underestimation of blood pressure. Aim To measure prevalence of an inter-arm blood pressure difference in patients with type 2 diabetes, and to estimate how frequently blood pressure measurements could be erroneously underestimated if an inter-arm difference is unrecognised. Design of study Cross-sectional study. Setting Five surgeries covered by three general practices, Devon, England. Method Patients with type 2 diabetes underwent bilateral simultaneous blood pressure measurements using a validated protocol. Mean blood pressures were calculated for each arm to derive mean systolic and diastolic differences, and to estimate point prevalence of predefined magnitudes of difference. Results A total of 101 participants were recruited. Mean age was 66 years (standard deviation [SD] = 13.9 years); 59% were male, and mean blood pressure was 138/79 mmHg (SD = 15/10 mmHg). Ten participants (10%; 95% confidence interval [CI] = 4 to 16) had a systolic inter-arm difference ≥10 mmHg; 29 (29%; 95% CI = 20 to 38) had a diastolic difference ≥5 mmHg; and three (3%; 95% CI = 0 to 6) a diastolic difference ≥10 mmHg. No confounding variable was observed to account for the magnitude of an inter-arm difference. Conclusion A systolic inter-arm difference ≥10 mmHg was observed in 10% of patients with diabetes. Failure to recognise this would misclassify half of these as normotensive rather than hypertensive using the lower-reading arm. New patients with type 2 diabetes should be screened for an inter-arm blood pressure difference. PMID:19520026

Local Jurisdictions and Active Shooters: Building Networks, Building Capacities

DTIC Science & Technology

2010-12-01

coordination will be the foundation for identifying relevant sources and materials on the armed active shooter assault. This research will also benefit...CONCLUSION In summary, the literature review identified relevant sources and materials on the importance of an armed attack. While an armed assault...armed with the following: dozens of explosive devices of varying potency, seven knives, two Savage-Stevens 12 gauge double- barrel shotguns with the

Comparison of intervention effects in split-mouth and parallel-arm randomized controlled trials: a meta-epidemiological study

PubMed Central

2014-01-01

Background Split-mouth randomized controlled trials (RCTs) are popular in oral health research. Meta-analyses frequently include trials of both split-mouth and parallel-arm designs to derive combined intervention effects. However, carry-over effects may induce bias in split- mouth RCTs. We aimed to assess whether intervention effect estimates differ between split- mouth and parallel-arm RCTs investigating the same questions. Methods We performed a meta-epidemiological study. We systematically reviewed meta- analyses including both split-mouth and parallel-arm RCTs with binary or continuous outcomes published up to February 2013. Two independent authors selected studies and extracted data. We used a two-step approach to quantify the differences between split-mouth and parallel-arm RCTs: for each meta-analysis. First, we derived ratios of odds ratios (ROR) for dichotomous data and differences in standardized mean differences (∆SMD) for continuous data; second, we pooled RORs or ∆SMDs across meta-analyses by random-effects meta-analysis models. Results We selected 18 systematic reviews, for 15 meta-analyses with binary outcomes (28 split-mouth and 28 parallel-arm RCTs) and 19 meta-analyses with continuous outcomes (28 split-mouth and 28 parallel-arm RCTs). Effect estimates did not differ between split-mouth and parallel-arm RCTs (mean ROR, 0.96, 95% confidence interval 0.52–1.80; mean ∆SMD, 0.08, -0.14–0.30). Conclusions Our study did not provide sufficient evidence for a difference in intervention effect estimates derived from split-mouth and parallel-arm RCTs. Authors should consider including split-mouth RCTs in their meta-analyses with suitable and appropriate analysis. PMID:24886043

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

Movement quality of conventional prostheses and the DEKA Arm during everyday tasks

PubMed Central

Cowley, Jeffrey; Resnik, Linda; Wilken, Jason; Walters, Lisa Smurr; Gates, Deanna

2017-01-01

Background Conventional prosthetic devices fail to restore the function and characteristic movement quality of the upper limb. The DEKA Arm is a new, advanced prosthesis featuring a compound, powered wrist and multiple grip configurations. Objectives The purpose of this study was to determine if the DEKA Arm improved the movement quality of upper limb prosthesis users compared to conventional prostheses. Study design Case series. Methods Three people with transradial amputation completed tasks of daily life with their conventional prosthesis and with the DEKA Arm. A total of 10 healthy controls completed the same tasks. The trajectory of the wrist joint center was analyzed to determine how different prostheses affected movement duration, speed, smoothness, and curvature compared to patients’ own intact limbs and controls. Results Movement quality decreased with the DEKA Arm for two participants, and increased for the third. Prosthesis users made slower, less smooth, more curved movements with the prosthetic limb compared to the intact limb and controls, particularly when grasping and manipulating objects. Conclusion The effects of one month of training with the DEKA Arm on movement quality varied with participants’ skill and experience with conventional prostheses. Future studies should examine changes in movement quality after long-term use of advanced prostheses. PMID:26932980

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

Muscle Hypertrophy in Prepubescent Tennis Players: A Segmentation MRI Study

PubMed Central

Sanchis-Moysi, Joaquin; Idoate, Fernando; Serrano-Sanchez, Jose A.; Dorado, Cecilia; Calbet, Jose A. L.

2012-01-01

Purpose To asses if tennis at prepubertal age elicits the hypertrophy of dominant arm muscles. Methods The volume of the muscles of both arms was determined using magnetic resonance imaging (MRI) in 7 male prepubertal tennis players (TP) and 7 non-active control subjects (CG) (mean age 11.0±0.8 years, Tanner 1–2). Results TP had 13% greater total muscle volume in the dominant than in the contralateral arm. The magnitude of inter-arm asymmetry was greater in TP than in CG (13 vs 3%, P<0.001). The dominant arm of TP was 16% greater than the dominant arm of CG (P<0.01), whilst non-dominant arms had similar total muscle volumes in both groups (P = 0.25), after accounting for height as covariate. In TP, dominant deltoid (11%), forearm supinator (55%) and forearm flexors (21%) and extensors (25%) were hypertrophied compared to the contralateral arm (P<0.05). In CG, the dominant supinator muscle was bigger than its contralateral homonimous (63%, P<0.05). Conclusions Tennis at prepubertal age is associated with marked hypertrophy of the dominant arm, leading to a marked level of asymmetry (+13%), much greater than observed in non-active controls (+3%). Therefore, tennis particpation at prepubertal age is associated with increased muscle volumes in dominant compared to the non-dominant arm, likely due to selectively hypertrophy of the loaded muscles. PMID:22428074

Inter-Arm Difference in Brachial Blood Pressure in the General Population of Koreans

PubMed Central

Song, Bo Mi; Shim, Jee-Seon; Lee, Myung Ha; Choi, Dong Phil

2016-01-01

Background and Objectives We investigated the inter-arm difference in blood pressure of the general Korean population to identify associated factors. Subjects and Methods A total of 806 participants aged 30 to 64 years without history of major cardiovascular disease were analyzed in this cross-sectional study. They participated in the Cardiovascular and Metabolic Disease Etiology Research Center cohort study that began in 2013. Brachial blood pressure was measured simultaneously for both arms using an automated oscillometric device equipped with two cuffs in seated position. After five minutes of rest, systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured three times. The average of the three measurements was used for analysis. Multivariate logistic regression models were used to identify factors associated with inter-arm differences in blood pressure. Results The mean inter-arm difference was 3.3 mmHg for SBP and 2.0 mmHg for DBP. Large inter-arm differences (≥10 mmHg) in SBP and in DBP were found in 3.7% and 0.9% of subjects, respectively. A large inter-arm difference in SBP was associated with mean SBP (p=0.002) and C-reactive protein (p=0.014) while a large inter-arm different in DBP was only associated with body mass index (p=0.015). Sex, age, and anti-hypertensive medication use were not associated with differences in inter-arm blood pressure. Conclusion Large inter-arm difference in blood pressure is only present in a small portion of healthy Korean adults. Our findings suggest that high SBP, chronic inflammation, and obesity may be associated with larger difference in inter-arm blood pressure. PMID:27275174

The effect of arm weight support on upper limb muscle synergies during reaching movements

PubMed Central

2014-01-01

Background Compensating for the effect of gravity by providing arm-weight support (WS) is a technique often utilized in the rehabilitation of patients with neurological conditions such as stroke to facilitate the performance of arm movements during therapy. Although it has been shown that, in healthy subjects as well as in stroke survivors, the use of arm WS during the performance of reaching movements leads to a general reduction, as expected, in the level of activation of upper limb muscles, the effects of different levels of WS on the characteristics of the kinematics of motion and of the activity of upper limb muscles have not been thoroughly investigated before. Methods In this study, we systematically assessed the characteristics of the kinematics of motion and of the activity of 14 upper limb muscles in a group of 9 healthy subjects who performed 3-D arm reaching movements while provided with different levels of arm WS. We studied the hand trajectory and the trunk, shoulder, and elbow joint angular displacement trajectories for different levels of arm WS. Besides, we analyzed the amplitude of the surface electromyographic (EMG) data collected from upper limb muscles and investigated patterns of coordination via the analysis of muscle synergies. Results The characteristics of the kinematics of motion varied across WS conditions but did not show distinct trends with the level of arm WS. The level of activation of upper limb muscles generally decreased, as expected, with the increase in arm WS. The same eight muscle synergies were identified in all WS conditions. Their level of activation depended on the provided level of arm WS. Conclusions The analysis of muscle synergies allowed us to identify a modular organization underlying the generation of arm reaching movements that appears to be invariant to the level of arm WS. The results of this study provide a normative dataset for the assessment of the effects of the level of arm WS on muscle synergies in stroke survivors and other patients who could benefit from upper limb rehabilitation with arm WS. PMID:24594139

Phase II, randomized study of concomitant chemoradiotherapy followed by surgery and adjuvant capecitabine plus oxaliplatin (CAPOX) compared with induction CAPOX followed by concomitant chemoradiotherapy and surgery in magnetic resonance imaging-defined, locally advanced rectal cancer: Grupo cancer de recto 3 study.

PubMed

Fernández-Martos, Carlos; Pericay, Carles; Aparicio, Jorge; Salud, Antonieta; Safont, Mariajose; Massuti, Bertomeu; Vera, Ruth; Escudero, Pilar; Maurel, Joan; Marcuello, Eugenio; Mengual, Jose Luis; Saigi, Eugenio; Estevan, Rafael; Mira, Moises; Polo, Sonia; Hernandez, Ana; Gallen, Manuel; Arias, Fernando; Serra, Javier; Alonso, Vicente

2010-02-10

PURPOSE The optimal therapeutic sequence of the adjuvant chemotherapy component of preoperative chemoradiotherapy (CRT) for patients with locally advanced rectal cancer is controversial. Induction chemotherapy before preoperative CRT may be associated with better efficacy and compliance. PATIENTS AND METHODS A total of 108 patients with locally advanced rectal cancer were randomly assigned to arm A-preoperative CRT with capecitabine, oxaliplatin, and concurrent radiation followed by surgery and four cycles of postoperative adjuvant capecitabine and oxaliplatin (CAPOX)-or arm B-induction CAPOX followed by CRT and surgery. The primary end point was pathologic complete response rate (pCR). Results On an intention-to-treat basis, the pCR for arms A and B were 13.5% (95% CI, 5.6% to 25.8%) and 14.3% (95% CI, 6.4% to 26.2%), respectively. There were no statistically significant differences in other end points, including downstaging, tumor regression, and R0 resection. Overall, chemotherapy treatment exposure was higher in arm B than in arm A for both oxaliplatin (P < .0001) and capecitabine (P < .0001). During CRT, grades 3 to 4 adverse events were similar in both arms but were significantly higher in arm A during postoperative adjuvant CT than with induction CT in arm B. There were three deaths in each arm during the treatment period. CONCLUSION Compared with postoperative adjuvant CAPOX, induction CAPOX before CRT had similar pCR and complete resection rates. It did achieve more favorable compliance and toxicity profiles. On the basis of these findings, a phase III study to definitively test the induction strategy is warranted.

Relationships between full-day arm movement characteristics and developmental status in infants with typical development as they learn to reach: An observational study

PubMed Central

Shida-Tokeshi, Joanne; Lane, Christianne J.; Trujillo-Priego, Ivan A.; Deng, Weiyang; Vanderbilt, Douglas L.; Loeb, Gerald E.; Smith, Beth A.

2018-01-01

Background: Advances in wearable sensor technology now allow us to quantify the number, type and kinematic characteristics of bouts of infant arm movement made across a full day in the natural environment. Our aim here was to determine whether the amount and kinematic characteristics of arm movements made across the day in the natural environment were related to developmental status in infants with typical development as they learned to reach for objects using their arms. Methods: We used wearable sensors to measure arm movement across days and months as infants developed arm reaching skills. In total, 22 infants with typical development participated, aged between 38 and 203 days. Of the participants, 2 infants were measured once and the other 20 infants were measured once per month for 3 to 6 visits. The Bayley Scales of Infant Development was used to measure developmental level. Results: Our main findings were: 1) infant arm movement characteristics as measured by full-day wearable sensor data were related to Bayley motor, cognitive and language scores, indicating a relationship between daily movement characteristics and developmental status; 2) infants who moved more had larger increases in language and cognitive scores across visits; and 3) larger changes in movement characteristics across visits were related to higher motor scores. Conclusions: This was a preliminary, exploratory, small study of the potential importance of infant arm movement characteristics as measured by full-day wearable sensor data. Our results support full-day arm movement activity as an area of interest for future study as a biomarker of neurodevelopmental status and as a target for early intervention. PMID:29708221

Prevalence of inter-arm blood pressure difference among clinical out-patients

PubMed Central

Sharma, Balkishan; Ramawat, Pramila

2016-01-01

Objectives An increased inter-arm blood pressure difference is an easily determined physical finding, may use as an indicator of cardio vascular event and other sever diseases. Authors evaluated 477 patients to determine the prevalence and significance of inter-arm blood pressure difference. Methodology 477 routine outdoor patients selected to observe the inter-arm blood pressure difference. Age, height, weight, body mass index, history of disease and blood pressure recorded. Results The prevalence of ≥10 mmHg systolic inter-arm blood pressure difference was 5.0% was more as compared to 3.8% had diastolic inter-arm blood pressure difference. The prevalence of systolic and diastolic inter-arm difference between 6 to 10 mmHg was 31.4% and 27.9% respectively. Mean systolic inter-arm blood pressure difference was significantly higher among those patients had a multisystem disorder (10.57±0.98 mmHg) and followed by patients with cardiovascular disease (10.22±0.67 mmHg) as compared to healthy patients (2.71±0.96 mmHg). Various diseases highly influenced the increase in blood pressure irrespective of systolic or diastolic was confirmed strongly significant (p<0.001) at different inter arm blood pressure difference levels. Conclusion This study supports the view of inter-arm blood pressure difference as an alarming stage of increased disease risk that incorporated to investigate potential problems at an early diagnostic stage. A significant mean difference between left and right arm blood pressure recorded for many diseases. PMID:27103905

Intraoperative brachial plexus injury during emergence following movement with arms restrained: a preventable complication?

PubMed Central

Chandler, Mark H; DiMatteo, Laura; Hasenboehler, Erik A; Temple, Michael

2007-01-01

Background Despite considerable analysis and preventive strategies, brachial plexus injuries remain fairly common in the perioperative setting. These injuries range from brief periods of numbness or discomfort in the immediate postoperative period to, in rare cases, profound, prolonged losses of sensation and function. We present a case of an orthopedic surgery patient who suffered a brachial plexus injury while under anesthesia after trying to sit upright with his arms restrained. Case presentation After the uneventful placement of an intramedullary tibial nail, an 18 year old patient tried to sit upright with his arms restrained while still under the influence of anesthesia. In the immediate postoperative period, the patient complained of a profound loss of sensation in his left arm and an inability to flex his left elbow, suppinate his arm, or abduct and rotate his shoulder. Neurological examination and subsequent studies revealed a C5-6 brachial plexus injury. The patient underwent range of motion physical therapy and, over the next three months, regained the full function and sensation of his left arm. Conclusion Restraining arms during general anesthesia to prevent injury remains a wise practice. However, to avoid injuring the brachial plexus while the arms are restrained, extra caution must be used to prevent unexpected patient movement and to ensure gentle emergence. PMID:18271944

Safety and efficacy of nivolumab and standard chemotherapy drug combination in patients with advanced non-small-cell lung cancer: a four arms phase Ib study

PubMed Central

Kanda, S.; Goto, K.; Shiraishi, H.; Kubo, E.; Tanaka, A.; Utsumi, H.; Sunami, K.; Kitazono, S.; Mizugaki, H.; Horinouchi, H.; Fujiwara, Y.; Nokihara, H.; Yamamoto, N.; Hozumi, H.; Tamura, T.

2016-01-01

Background The human IgG4 monoclonal antibody nivolumab targets programmed cell death-1 (PD-1) and promotes antitumor response by blocking the interaction of PD-1 with its ligands. This single-center phase Ib study investigated the tolerability, safety, and pharmacokinetics of nivolumab combined with standard chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC). Patients and methods Patients who had stage IIIB without indication for definitive radiotherapy, stage IV, or recurrent NSCLC were eligible. Regimens were nivolumab 10 mg/kg + gemcitabine/cisplatin (arm A), pemetrexed/cisplatin (arm B), paclitaxel/carboplatin/bevacizumab (arm C), or docetaxel (arm D). Regimens A, B, and D were repeated every 3 weeks for up to four cycles and regimen C was repeated for up to six cycles; nivolumab alone (arm A), with pemetrexed (arm B), bevacizumab (arm C), or docetaxel (arm D) was continued every 3 weeks as maintenance therapy until disease progression or unacceptable toxicity. Dose-limiting toxicity (DLT) was evaluated during the first treatment cycle. Results As of March 2014, six patients were enrolled in each arm. The combination of nivolumab 10 mg/kg and chemotherapy was well tolerated. DLT was observed in only one patient in arm A (alanine aminotransferase increased). Select adverse events (those with a potential immunologic cause) of any grade were observed in six, four, six, and five patients in arms A, B, C, and D, respectively. Three, three, six, and one patient achieved partial response while median progression-free survival was 6.28, 9.63 months, not reached, and 3.15 months in arms A, B, C, and D, respectively. Conclusions Combination of nivolumab 10 mg/kg and chemotherapy showed an acceptable toxicity profile and encouraging antitumor activity in patients with advanced NSCLC. Clinical trials number Japanese Pharmaceutical Information Center Clinical Trials Information (JapicCTI)-132071. PMID:27765756

Influence of the prosthetic arm length (palatal position) of zygomatic implants upon patient satisfaction

PubMed Central

Pellicer-Chover, Hilario; Cervera-Ballester, Juan; Peñarrocha-Oltra, David; Bagán, Leticia; Peñarrocha-Diago, María

2016-01-01

Background To assess the influence of the prosthetic arm length (palatal position) of zygomatic implants upon patient comfort and stability, speech, functionality and overall satisfaction. Material and Methods A retrospective clinical study was made of patients subjected to rehabilitation of atrophic maxilla with complete maxillary implant-supported fixed prostheses involving a minimum of two zygomatic implants (one on each side) in conjunction with premaxillary implants, and with 12 months of follow-up after implant loading. Subjects used a VAS to score general satisfaction, comfort and stability, speech and functionality, and the results were analyzed in relation to the prosthetic arm length of the zygomatic implants 12 months after prosthetic delivery. Results Twenty-two patients participated in the study, receiving 22 prostheses anchored on 148 implants (44 were zygomatic and 94 were conventional implants). The mean right and left prosthetic arm length was 5.9±2.4 mm and 6.1±2.7 mm, respectively, with no statistically significant differences between them (p=0.576). The mean scores referred to comfort/retention, speech, functionality and overall satisfaction were high - no correlation being found between prosthetic arm length and patient satisfaction (p=0.815). Conclusions No relationship could be identified between prosthetic arm length (palatal position) and patient satisfaction. Key words:Zygomatic implants, patient satisfaction, zygomatic prosthesis, prosthetic arm length. PMID:26946206

Nordic Balance: Sweden, a Case Study.

DTIC Science & Technology

A strategic appraisal of the Swedish Armed Forces is set against the background of other elements of national power. Although Sweden is a small country, the analysis leads to the conclusion that the strength of the Swedish Armed Forces contributes significantly to the military balance of the Scandinavian region. Situated between the major power blocs represented by NATO and the Warsaw Pact countries, Sweden pursues an alliance-free foreign policy which also enhances regional military/ political stability , termed ’Nordic Balance’. (Modified author abstract)

Subclavian Vein Versus Arm Vein for Totally Implantable Central Venous Port for Patients with Head and Neck Cancer: A Retrospective Comparative Analysis

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

Akahane, Akio, E-mail: a.akahane@gmail.com; Sone, Miyuki; Ehara, Shigeru

2011-12-15

Purpose: This study was designed to compare central venous ports (CVP) from two different routes of venous access-the subclavian vein and arm vein-in terms of safety for patients with head and neck cancer (HNC). Methods: Patients with HNC who underwent image-guided implantations of CVPs were retrospectively evaluated. All CVPs were implanted under local anesthesia. Primary outcome measurements were rates and types of adverse events (AEs). Secondary outcomes included technical success and rate and reason of CVP removal. Results: A total of 162 patients (subclavian port group, 47; arm port group, 115) were included in this study. Technical success was achievedmore » in all patients. The median follow-up period was 94 (range, 1-891) days. Two patients in the subclavian port group experienced periprocedural complications. Postprocedural AEs were observed in 8.5 and 22.6% of the subclavian port and arm port group patients, respectively (P = 0.044). Phlebitis and system occlusions were observed only in the arm port group. The rate of infection was not significantly different between the two groups. The CVP was removed in 34 and 39.1% of the subclavian port and arm port patients, respectively. Conclusions: Both subclavian and arm CVPs are feasible in patients with HNC. AEs were more frequent in the arm port group; thus, the arm port is not recommended as the first choice for patients with HNC. However, further experience is needed to improve the placement technique and the maintenance of CVPs and a prospective analysis is warranted.« less

Rifaximin has a Marginal Impact on Microbial Translocation, T-cell Activation and Inflammation in HIV-Positive Immune Non-responders to Antiretroviral Therapy – ACTG A5286

PubMed Central

Tenorio, Allan R.; Chan, Ellen S.; Bosch, Ronald J.; Macatangay, Bernard J. C.; Read, Sarah W.; Yesmin, Suria; Taiwo, Babafemi; Margolis, David M.; Jacobson, Jeffrey M.; Landay, Alan L.; Wilson, Cara C.; Mellors, John W.; Keshavarzian, Ali; Rodriguez, Benigno; Aziz, Mariam; Presti, Rachel; Deeks, Steven; Ebiasah, Ruth; Myers, Laurie; Borowski, LuAnn; Plants, Jill; Palm, David A.; Weibel, Derek; Putnam, Beverly; Lindsey, Elizabeth; Player, Amy; Albrecht, Mary; Kershaw, Andrea; Sax, Paul; Keenan, Cheryl; Walton, Patricia; Baum, Jane; Stroberg, Todd; Hughes, Valery; Coster, Laura; Kumar, Princy N.; Yin, Michael T.; Noel-Connor, Jolene; Tebas, Pablo; Thomas, Aleshia; Davis, Charles E.; Redfield, Robert R.; Sbrolla, Amy; Flynn, Teri; Davis, Traci; Whitely, Kim; Singh, Baljinder; Swaminathan, Shobha; McGregor, Donna; Palella, Frank; Aberg, Judith; Cavanagh, Karen; Santana Bagur, Jorge L.; Flores, Olga Méndez; Fritsche, Janice; Sha, Beverly; Slamowitz, Debbie; Valle, Sandra; Tashima, Karen; Patterson, Helen; Harber, Heather; Para, Michael; Eaton, Molly; Maddox, Dale; Currier, Judith; Cajahuaringa, Vanessa; Luetkemeyer, Annie; Dwyer, Jay; Fichtenbaum, Carl J.; Saemann, Michelle; Ray, Graham; Campbell, Thomas; Fischl, Margaret A.; Bolivar, Hector; Oakes, Jonathan; Chicurel-Bayard, Miriam; Tripoli, Christine; Weinman, D. Renee; Adams, Mary; Hurley, Christine; Dunaway, Shelia; Storey, Sheryl; Klebert, Michael; Royal, Michael

2015-01-01

Background. Rifaximin, a nonabsorbable antibiotic that decreases lipopolysaccharide (LPS) in cirrhotics, may decrease the elevated levels of microbial translocation, T-cell activation and inflammation in human immunodeficiency virus (HIV)-positive immune nonresponders to antiretroviral therapy (ART). Methods. HIV-positive adults receiving ART for ≥96 weeks with undetectable viremia for ≥48 weeks and CD4+ T-cell counts <350 cells/mm3 were randomized 2:1 to rifaximin versus no study treatment for 4 weeks. T-cell activation, LPS, and soluble CD14 were measured at baseline and at weeks 2, 4, and 8. Wilcoxon rank sum tests compared changes between arms. Results. Compared with no study treatment (n = 22), rifaximin (n = 43) use was associated with a significant difference between study arms in the change from baseline to week 4 for CD8+T-cell activation (median change, 0.0% with rifaximin vs +0.6% with no treatment; P = .03). This difference was driven by an increase in the no-study-treatment arm because there was no significant change within the rifaximin arm. Similarly, although there were significant differences between study arms in change from baseline to week 2 for LPS and soluble CD14, there were no significant changes within the rifaximin arm. Conclusions. In immune nonresponders to ART, rifaximin minimally affected microbial translocation and CD8+T-cell activation. Trial registration number. NCT01466595. PMID:25214516

French multicenter phase III randomized study testing concurrent twice-a-day radiotherapy and cisplatin/5-fluorouracil chemotherapy (BiRCF) in unresectable pharyngeal carcinoma: Results at 2 years (FNCLCC-GORTEC)

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

Bensadoun, Rene-Jean; Benezery, Karen; Dassonville, Olivier

Background: Unresectable carcinomas of the oropharynx and hypopharynx still have a poor long-term prognosis. Following a previous phase II study, this phase III multicenter trial was conducted between November 1997 and March 2002. Methods: Nontreated, strictly unresectable cases were eligible. Twice-daily radiation: two fractions of 1.2 Gy/day, 5 days per week, with no split (D1{sup {yields}}D46). Total tumor doses: 80.4 Gy/46 day (oropharynx), 75.6 Gy/44 day (hypopharynx). Chemotherapy (arm B): Cisplatin 100 mg/m{sup 2} (D1, D22, D43); 5FU, continuous infusion (D1{sup {yields}}D5), 750 mg/m{sup 2}/day cycle 1; 430 mg/m{sup 2}/day cycles 2 and 3. Results: A total of 163 evaluablemore » patients. Grade 3-4 acute mucositis 82.6% arm B/69.5% arm A (NS); Grade 3-4 neutropenia 33.3% arm B/2.4% arm A (p < 0.05). Enteral nutrition through gastrostomy tube was more frequent in arm B before treatment and at 6 months (p < 0.01). At 24 months, overall survival (OS), disease-free survival (DFS), and specific survival (SS) were significantly better in arm B. OS: 37.8% arm B vs. 20.1% arm A (p = 0.038); DFS: 48.2% vs. 25.2% (p = 0.002); SS: 44.5% vs. 30.2% (p 0.021). No significant difference between the two arms in the amount of side effects at 1 and 2 years. Conclusion: For these unresectable cases, chemoradiation provides better outcome than radiation alone, even with an 'aggressive' dose-intensity radiotherapy schedule.« less

[Arm rehabilitation : Current concepts and therapeutic options].

PubMed

Platz, T; Schmuck, L

2016-10-01

Arm paralysis after a stroke is a major cause of impairment. Presentation of therapeutic options and the efficacy in arm rehabilitation after stroke. Based on a systematic critical appraisal of randomized controlled trials (RCT) the therapeutic procedures for arm paralysis after stroke in the context of their effectiveness are introduced, including robotic therapy, mirror therapy, constraint-induced movement therapy (CIMT), arm basis training, arm ability training, neuromuscular electrical stimulation, bilateral and task-specific training, mental training and transcranial stimulation techniques, such as repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS). Several therapeutic procedures with proven efficacy are currently available for arm rehabilitation after stroke. Their differential indications are presented and associated with conclusions for clinical practice.

Correlations of Handgrip Strength with Selected Hand-Arm-Anthropometric Variables in Indian Inter-university Female Volleyball Players

PubMed Central

Koley, Shyamal; Pal Kaur, Satinder

2011-01-01

Purpose The purpose of this study was to estimate the dominant handgrip strength and its correlations with some hand and arm anthropometric variables in 101 randomly selected Indian inter-university female volleyball players aged 18-25 years (mean age 20.52±1.40) from six Indian universities. Methods Three anthropometric variables, i.e. height, weight, BMI, two hand anthropometric variables, viz. right and left hand width and length, four arm anthropometric variables, i.e. upper arm length, lower arm length, upper extremity length, upper arm circumference and dominant right and non-dominant handgrip strength were measured among Indian inter-university female volleyball players by standard anthropometric techniques. Results The findings of the present study indicated that Indian female volleyball players had higher mean values in eleven variables and lesser mean values in two variables than their control counterparts, showing significant differences (P<0.032-0.001) in height (t=2.63), weight (t=8.66), left hand width (t=2.10), left and right hand length (t=9.99 and 10.40 respectively), right upper arm length (t=8.48), right forearm length (t=5.41), dominant (right) and non-dominant (left) handgrip strength (t=9.37 and 6.76 respectively). In female volleyball players, dominant handgrip strength had significantly positive correlations (P=0.01) with all the variables studied. Conclusion It may be concluded that dominant handgrip strength had strong positive correlations with all the variables studied in Indian inter-university female volleyball players. PMID:22375242

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.

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.

Effect of Web-Based Versus Paper-Based Questionnaires and Follow-Up Strategies on Participation Rates of Dutch Childhood Cancer Survivors: A Randomized Controlled Trial

PubMed Central

van Dulmen-den Broeder, Eline; van der Pal, Helena J; Hollema, Nynke; Kremer, Leontien C; van den Heuvel-Eibrink, Marry M; van Leeuwen, Flora E

2015-01-01

Background Questionnaires are widely used in survey research, especially in cohort studies. However, participation in questionnaire studies has been declining over the past decades. Because high participation rates are needed to limit the risk of selection bias and produce valid results, it is important to investigate invitation strategies which may improve participation. Objectives The purpose of this study is to investigate the effect of Web-based versus paper-based questionnaires on participation rates in a questionnaire survey on late effects among childhood cancer survivors (CCSs). Methods A total of 750 CCSs were randomized across 3 study arms. The initial invitation in study arms 1 and 2 consisted of a Web-based questionnaire only, whereas in study arm 3 this invitation was complemented with a paper-based version of the questionnaire. The first postal reminder, sent to the nonresponding CCSs in all 3 study arms, consisted of either a reminder letter only (study arms 1 and 3) or a reminder letter complemented with a paper-based questionnaire (study arm 2). The second postal reminder was restricted to CCSs in study arms 1 and 2, with only those in study arm 1 also receiving a paper-based questionnaire. CCSs in study arm 3 received a second reminder by telephone instead of by mail. In contrast to CCSs in study arm 3, CCSs in study arms 1 and 2 received a third reminder, this time by telephone. Results: Overall, 58.1% (436/750) of the CCSs participated in the survey. Participation rates were equal in all 3 study arms with 57.4% (143/249) in arm 1, 60.6% (152/251) in arm 2, and 56.4% (141/250) in arm 3 (P=.09). Participation rates of CCSs who received an initial invitation for the Web-based questionnaire only and CCSs who received an invitation to complete either a paper-based or Web-based questionnaire did not differ (P=.55). After the first postal reminder, participation rates of CCSs invited for the Web-based questionnaire only also did not differ compared with CCSs invited for both the Web-based and paper-based questionnaires (P=.48). In general, CCSs preferred the paper-based over the Web-based questionnaire, and those completing the paper-based questionnaire were more often unemployed (P=.004) and lower educated (P<.001). Conclusion Invitation strategies offering a Web-based questionnaire without a paper-based alternative at first invitation can be used without compromising participation rates of CCS. Offering the choice between paper- and Web-based questionnaires seems to result in the highest accrual participation rate. Future research should look into the quality of the data delivered by both questionnaires filled in by respondents themselves. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 84711754; http://www.controlled-trials.com/ISRCTN84711754 (Archived by WebCite at http://www.webcitation.org/6c9ZB8paX) PMID:28410161

Brazilian Arms Production: Partial Dependence

DTIC Science & Technology

1988-09-01

neighbors, before the Great Depression Brazil relied upon the export of primary commodities such as coffee, sugar and cocoa for its hard currency...24 Conclusions 26 Appendix 29 - VII - TABLES A.l. Brazilian arms exports and imports, 1968-86 30 A.2. Destination of...Embracr aircraft delivered outside of Brazil, 1975- 83 31 FIGURE 1. Brazilian arms exports and imports, 1968-86 25 IX - ACKNOWLEDGMENTS

Cost-effectiveness of initiating antiretroviral therapy at different points in TB treatment in HIV-TB co-infected ambulatory patients in South Africa

PubMed Central

Naidoo, Kogieleum; Grobler, Anneke C; Deghaye, Nicola; Reddy, Tarylee; Gengiah, Santhanalakshmi; Gray, Andrew; Karim, Salim Abdool

2015-01-01

Objective Initiation of antiretroviral therapy (ART) during tuberculosis (TB) treatment improves survival in TB-HIV co-infected patients. In patients with CD4+ counts <50cells/mm3, there is a substantial clinical and survival benefit of early ART initiation. The purpose of this study was to assess the costs and cost effectiveness of starting ART at various time points during TB treatment in patients with CD4+ counts ≥50cells/mm3. Methods In the SAPiT trial, 642 HIV-TB co-infected patients were randomized to three arms, either receiving ART within 4 weeks of starting TB treatment (early treatment arm; Arm-1), after the intensive phase of TB treatment (late treatment arm; Arm-2), or after completing TB treatment (sequential arm; Arm-3). Direct healthcare costs were measured from a provider perspective using a micro-costing approach. The incremental cost per death averted was calculated using the trial outcomes. Results For patients with CD4+ count≥50cells/mm3, median monthly variable costs per patient were $116, $113 and $102 in Arms-1, -2 and -3, respectively. There were 12 deaths in 177 patients in Arm-1, 8 deaths in 180 patients in the Arm-2 and 19 deaths in 172 patients in Arm-3. While the costs were lower in Arm-3, it had a substantially higher mortality rate. The incremental cost per death averted associated with moving from Arm-3 to Arm-2 was $4199. There was no difference in mortality between Arm-1 and Arm-2, but Arm-1 was slightly more expensive. Conclusions Initiation of ART after the completion of the intensive phase of TB treatment is cost effective for patients with CD4+ counts≥50cells/mm3. PMID:26167618

Development, Resources and World Security

ERIC Educational Resources Information Center

Bulletin of the Atomic Scientists, 1976

1976-01-01

Summarizes the findings and conclusions of the 1976 Pugwash Conference. Issues discussed included limits on individual income or consumption, natural resource usage, arms influx into developing nations, nuclear arms control, transfer of peaceful nuclear technology, and rising military expenditures. (GS)

Toward attenuating the impact of arm positions on electromyography pattern-recognition based motion classification in transradial amputees

PubMed Central

2012-01-01

Background Electromyography (EMG) pattern-recognition based control strategies for multifunctional myoelectric prosthesis systems have been studied commonly in a controlled laboratory setting. Before these myoelectric prosthesis systems are clinically viable, it will be necessary to assess the effect of some disparities between the ideal laboratory setting and practical use on the control performance. One important obstacle is the impact of arm position variation that causes the changes of EMG pattern when performing identical motions in different arm positions. This study aimed to investigate the impacts of arm position variation on EMG pattern-recognition based motion classification in upper-limb amputees and the solutions for reducing these impacts. Methods With five unilateral transradial (TR) amputees, the EMG signals and tri-axial accelerometer mechanomyography (ACC-MMG) signals were simultaneously collected from both amputated and intact arms when performing six classes of arm and hand movements in each of five arm positions that were considered in the study. The effect of the arm position changes was estimated in terms of motion classification error and compared between amputated and intact arms. Then the performance of three proposed methods in attenuating the impact of arm positions was evaluated. Results With EMG signals, the average intra-position and inter-position classification errors across all five arm positions and five subjects were around 7.3% and 29.9% from amputated arms, respectively, about 1.0% and 10% low in comparison with those from intact arms. While ACC-MMG signals could yield a similar intra-position classification error (9.9%) as EMG, they had much higher inter-position classification error with an average value of 81.1% over the arm positions and the subjects. When the EMG data from all five arm positions were involved in the training set, the average classification error reached a value of around 10.8% for amputated arms. Using a two-stage cascade classifier, the average classification error was around 9.0% over all five arm positions. Reducing ACC-MMG channels from 8 to 2 only increased the average position classification error across all five arm positions from 0.7% to 1.0% in amputated arms. Conclusions The performance of EMG pattern-recognition based method in classifying movements strongly depends on arm positions. This dependency is a little stronger in intact arm than in amputated arm, which suggests that the investigations associated with practical use of a myoelectric prosthesis should use the limb amputees as subjects instead of using able-body subjects. The two-stage cascade classifier mode with ACC-MMG for limb position identification and EMG for limb motion classification may be a promising way to reduce the effect of limb position variation on classification performance. PMID:23036049

Are we drawing the right conclusions from randomised placebo-controlled trials? A post-hoc analysis of data from a randomised controlled trial

PubMed Central

2009-01-01

Background Assumptions underlying placebo controlled trials include that the placebo effect impacts on all study arms equally, and that treatment effects are additional to the placebo effect. However, these assumptions have recently been challenged, and different mechanisms may potentially be operating in the placebo and treatment arms. The objective of the current study was to explore the nature of placebo versus pharmacological effects by comparing predictors of the placebo response with predictors of the treatment response in a randomised, placebo-controlled trial of a phytotherapeutic combination for the treatment of menopausal symptoms. A substantial placebo response was observed but no significant difference in efficacy between the two arms. Methods A post hoc analysis was conducted on data from 93 participants who completed this previously published study. Variables at baseline were investigated as potential predictors of the response on any of the endpoints of flushing, overall menopausal symptoms and depression. Focused tests were conducted using hierarchical linear regression analyses. Based on these findings, analyses were conducted for both groups separately. These findings are discussed in relation to existing literature on placebo effects. Results Distinct differences in predictors were observed between the placebo and active groups. A significant difference was found for study entry anxiety, and Greene Climacteric Scale (GCS) scores, on all three endpoints. Attitude to menopause was found to differ significantly between the two groups for GCS scores. Examination of the individual arms found anxiety at study entry to predict placebo response on all three outcome measures individually. In contrast, low anxiety was significantly associated with improvement in the active treatment group. None of the variables found to predict the placebo response was relevant to the treatment arm. Conclusion This study was a post hoc analysis of predictors of the placebo versus treatment response. Whilst this study does not explore neurobiological mechanisms, these observations are consistent with the hypotheses that 'drug' effects and placebo effects are not necessarily additive, and that mutually exclusive mechanisms may be operating in the two arms. The need for more research in the area of mechanisms and mediators of placebo versus active responses is supported. Trial Registration International Clinical Trials Registry ISRCTN98972974. PMID:19549306

Phase 1 trial of the oral AKT inhibitor MK-2206 plus carboplatin/paclitaxel, docetaxel, or erlotinib in patients with advanced solid tumors

PubMed Central

2014-01-01

Background Inhibition of AKT with MK-2206 has demonstrated synergism with anticancer agents. This phase 1 study assessed the MTD, DLTs, PK, and efficacy of MK-2206 in combination with cytotoxic and targeted therapies. Methods Advanced solid tumor patients received oral MK-2206 45 or 60 mg (QOD) with either carboplatin (AUC 6.0) and paclitaxel 200 mg/m2 (arm 1), docetaxel 75 mg/m2 (arm 2), or erlotinib 100 or 150 mg daily (arm 3); alternative schedules of MK-2206 135-200 mg QW or 90-250 mg Q3W were also tested. Results MTD of MK-2206 (N = 72) was 45 mg QOD or 200 mg Q3W (arm 1); MAD was 200 mg Q3W (arm 2) and 135 mg QW (arm 3). DLTs included skin rash (arms 1, 3), febrile neutropenia (QOD, arms 1, 2), tinnitus (Q3W, arm 2), and stomatitis (QOD, arm 3). Common drug-related toxicities included fatigue (68%), nausea (49%), and rash (47%). Two patients with squamous cell carcinoma of the head and neck (arm 1; Q3W) demonstrated a complete and partial response (PR); additional PRs were observed in patients (1 each) with melanoma, endometrial, neuroendocrine prostate, NSCLC, and cervical cancers. Six patients had stable disease ≥6 months. Conclusion MK-2206 plus carboplatin and paclitaxel, docetaxel, or erlotinib was well-tolerated, with early evidence of antitumor activity. Trial registration ClinicalTrials.gov: NCT00848718. PMID:24387695

Management of Chemoradiation-Induced Mucositis in Head and Neck Cancers With Oral Glutamine

PubMed Central

Panda, Niharika; Dash, Manoj Kumar; Mohanty, Sumita; Samantaray, Sagarika

2016-01-01

Purpose Head and neck cancers are the third most common cancers worldwide. Oral mucositis is the most common toxicity seen in patients who receive chemoradiation to treat head and neck cancer. The aim of this study was to evaluate the efficacy and safety of oral glutamine supplementation in these patients. Materials and Methods From December 2013 to December 2014, we randomly assigned to two arms 162 patients who had squamous cell carcinoma of the head and neck. Patients in arm A were given oral glutamine once per day, whereas those in arm B served as negative control subjects. All patients received radiotherapy given as 70 Gy in 35 fractions over 7 weeks with an injection of cisplatin once per week. Patients were assessed once per week to evaluate for the onset and severity of mucositis, pain, use of analgesics, and for Ryle tube feeding. Results We observed that 53.1% of patients developed mucositis toward the fifth week in the glutamine arm compared with 55.5% of patients in the control arm at the third week. None in the glutamine arm compared with 92.35% of patients in the control arm developed G3 mucositis. Rates of adverse events like pain, dysphagia, nausea, edema, and cough, as well as use of analgesics and Ryle tube feeding, were significantly lower in the glutamine arm than in the control arm. Conclusion This study highlights that the onset as well as the severity of mucositis in patients receiving glutamine was significantly delayed. None of the patients receiving glutamine developed G3 mucositis. Hence, the findings emphasize the use of oral glutamine supplementation as a feasible and affordable treatment option for mucositis in patients with head and neck cancers who are receiving chemoradiation. PMID:28717702

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

PubMed Central

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

2017-01-01

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

Non-paretic arm force does not over-inhibit the paretic arm in chronic post-stroke hemiparesis

PubMed Central

Dimyan, Michael A.; Perez, Monica A.; Auh, Sungyoung; Tarula, Erick; Wilson, Matthew; Cohen, Leonardo G.

2014-01-01

Objective To determine whether non-paretic arm force over-inhibits the paretic arm in patients with chronic unilateral post-stroke hemiparesis. We hypothesized that interhemispheric inhibition would increase more in healthy controls than in hemiparetic patients. Design Case-control neurophysiologic and behavioral study of patients with chronic stroke. Setting Federal research institution, outpatient clinical research setting Participants Eighty-six referred patients were screened to enroll 9 participants with greater than 6 month history of one unilateral ischemic infarct that resulted in arm hemiparesis, with residual ability to produce 1Nm of wrist flexion torque, without contraindication to transcranial magnetic stimulation. 8 age- and handedness-matched healthy volunteers without neurologic diagnosis were studied for comparison. Interventions Not Applicable Main Outcome Measures Change in interhemispheric inhibition targeting the ipsilesional primary-motor-cortex (M1) during non-paretic arm force. Results Healthy age-matched controls had significantly greater increases in inhibition from their active to resting M1 than did stroke patients from their active contralesional to resting ipsilesional M1 in the same scenario (20% ±7 vs. −1% ±4, F1,12=6.61, p=0.0245). Patients with greater increases in contralesional to ipsilesional inhibition were better performers on the nine-hole-peg-test of paretic arm function. Conclusions Our findings reveal that producing force with the non-paretic arm does not necessarily over-inhibit the paretic arm. Though limited in generalizability by the small sample size, we found that greater active contralesional to resting ipsilesional M1 inhibition was related to better recovery in this subset of chronic post-stroke patients. PMID:24440364

Interlimb Differences in Coordination of Unsupported Reaching Movements

PubMed Central

Schaffer, Jacob E.; Sainburg, Robert L.

2017-01-01

Previous research suggests that interlimb differences in coordination associated with handedness might result from specialized control mechanisms that are subserved by different cerebral hemispheres. Based largely on the results of horizontal plane reaching studies, we have proposed that the hemisphere contralateral to the dominant arm is specialized for predictive control of limb dynamics, while the non-dominant hemisphere is specialized for controlling limb impedance. The current study explores interlimb differences in control of 3-D unsupported reaching movements. While the task was presented in the horizontal plane, participant’s arms were unsupported and free to move within a range of the vertical axis, which was redundant to the task plane. Results indicated significant dominant arm advantages for both initial direction accuracy and final position accuracy. The dominant arm showed greater excursion along a redundant axis that was perpendicular to the task, and parallel to gravitational forces. In contrast, the non-dominant arm better impeded motion out of the task-plane. Nevertheless, left arm task errors varied substantially more with shoulder rotation excursion than did dominant arm task errors. These findings suggest that the dominant arm controller was able to take advantage of the redundant degrees of freedom of the task, while non-dominant task errors appeared enslaved to motion along the redundant axis. These findings are consistent with a dominant controller that is specialized for intersegmental coordination, and a non-dominant controller that is specialized for impedance control. However, the findings are inconsistent with previously documented conclusions from planar tasks, in which non-dominant control leads to greater final position accuracy. PMID:28344068

The influence of goal-directed fluid therapy on the prognosis of elderly patients with hypertension and gastric cancer surgery

PubMed Central

Zeng, Kai; Li, Yanzhen; Liang, Min; Gao, Youguang; Cai, Hongda; Lin, Caizhu

2014-01-01

Purpose We aimed to investigate the influence of perioperative goal-directed fluid therapy (GDFT) on the prognosis of elderly patients with gastric cancer and hypertension. Methods Sixty elderly patients (>60 years old) with primary hypertension who received gastric cancer radical surgery and who were American Society of Anesthesiologists (ASA) class II or III were enrolled in the current study. Selected patients were divided randomly into two arms, comprising a conventional intraoperative fluid management arm (arm C, n=30) and a GDFT arm (arm G, n=30). Patients in arm C were infused with crystalloids or colloids according to the methods of Miller’s Anesthesia (6th edition), while those in arm G were infused with 200 mL hydroxyethyl starch over 15 minutes under the FloTrac/Vigileo monitoring system, with stroke volume variation between 8% and 13%. Hemodynamics and tissue perfusion laboratory indicators in patients were recorded continuously from 30 minutes before the operation to 24 hours after the operation. Results Compared with arm C, the average intraoperative intravenous infusion quantity in arm G was significantly reduced (2,732±488 mL versus 3,135±346 mL, P<0.05), whereas average colloid fluid volume was significantly increased (1,235±360 mL versus 760±280 mL, P<0.05). In addition, there were more patients exhibiting intraoperatively and postoperatively stable hemodynamics and less patients with low blood pressure in arm G. Postoperative complications were less frequent, and the time of postoperative hospital stay shorter, in arm G. No significant differences were observed in mortality between the two arms. Conclusion Our research showed that GDFT stabilized perioperative hemodynamics and reduced the occurrence of postoperative complications in elderly patients who underwent gastric cancer surgery. PMID:25378913

Estimation of Human Arm Joints Using Two Wireless Sensors in Robotic Rehabilitation Tasks.

PubMed

Bertomeu-Motos, Arturo; Lledó, Luis D; Díez, Jorge A; Catalan, Jose M; Ezquerro, Santiago; Badesa, Francisco J; Garcia-Aracil, Nicolas

2015-12-04

This paper presents a novel kinematic reconstruction of the human arm chain with five degrees of freedom and the estimation of the shoulder location during rehabilitation therapy assisted by end-effector robotic devices. This algorithm is based on the pseudoinverse of the Jacobian through the acceleration of the upper arm, measured using an accelerometer, and the orientation of the shoulder, estimated with a magnetic angular rate and gravity (MARG) device. The results show a high accuracy in terms of arm joints and shoulder movement with respect to the real arm measured through an optoelectronic system. Furthermore, the range of motion (ROM) of 50 healthy subjects is studied from two different trials, one trying to avoid shoulder movements and the second one forcing them. Moreover, the shoulder movement in the second trial is also estimated accurately. Besides the fact that the posture of the patient can be corrected during the exercise, the therapist could use the presented algorithm as an objective assessment tool. In conclusion, the joints' estimation enables a better adjustment of the therapy, taking into account the needs of the patient, and consequently, the arm motion improves faster.

A 3D musculoskeletal model of the western lowland gorilla hind limb: moment arms and torque of the hip, knee and ankle.

PubMed

Goh, Colleen; Blanchard, Mary L; Crompton, Robin H; Gunther, Michael M; Macaulay, Sophie; Bates, Karl T

2017-10-01

Three-dimensional musculoskeletal models have become increasingly common for investigating muscle moment arms in studies of vertebrate locomotion. In this study we present the first musculoskeletal model of a western lowland gorilla hind limb. Moment arms of individual muscles around the hip, knee and ankle were compared with previously published data derived from the experimental tendon travel method. Considerable differences were found which we attribute to the different methodologies in this specific case. In this instance, we argue that our 3D model provides more accurate and reliable moment arm data than previously published data on the gorilla because our model incorporates more detailed consideration of the 3D geometry of muscles and the geometric constraints that exist on their lines-of-action about limb joints. Our new data have led us to revaluate the previous conclusion that muscle moment arms in the gorilla hind limb are optimised for locomotion with crouched or flexed limb postures. Furthermore, we found that bipedalism and terrestrial quadrupedalism coincided more regularly with higher moment arms and torque around the hip, knee and ankle than did vertical climbing. This indicates that the ability of a gorilla to walk bipedally is not restricted by musculoskeletal adaptations for quadrupedalism and vertical climbing, at least in terms of moment arms and torque about hind limb joints. © 2017 The Authors. Journal of Anatomy published by John Wiley & Sons Ltd on behalf of Anatomical Society.

Efficacy of Topical Alpha Ointment (Containing Natural Henna) Compared to Topical Hydrocortisone (1%) in the Healing of Radiation-Induced Dermatitis in Patients with Breast Cancer: A Randomized Controlled Clinical Trial

PubMed Central

Ansari, Mansour; Dehsara, Farzin; Mosalaei, Ahmad; Omidvari, Shapour; Ahmadloo, Niloofar; Mohammadianpanah, Mohammad

2013-01-01

Background: This two-arm, randomized clinical study aimed to compare efficacy between topical Alpha ointment and topical hydrocortisone cream (1%) in the healing of radiation-induced dermatitis in breast cancer patients. Methods: The inclusion criteria comprised newly pathologically proven, locally advanced breast cancer (treated with modified radical mastectomy followed by sequential adjuvant treatments, including chest wall radiotherapy [45-50.4 Gy]) and grade 2 and/or 3 chest wall dermatitis. The exclusion criteria were comprised of any underlying disease or medications interfering with the wound healing process, previous history of chest wall radiotherapy, and concurrent use of chemotherapy. Sixty eligible patients were randomly assigned to use either topical Alpha ointment (study arm, n=30) or topical hydrocortisone cream (1%) (control arm, n=30) immediately after receiving a total dose of 45-50 Gy chest wall radiotherapy. Results: The mean radiation dose was 49.1 Gy in the control arm and 48.8 Gy in the study arm. The mean dermatitis area was 13.54 cm2 in the control arm and 17.02 cm2 in the study arm. Topical Alpha ointment was more effective on the healing of radiation-induced dermatitis than was topical hydrocortisone cream (1%) (P=0.001). This effect was significant in the second week (P=0.007). In addition, Alpha ointment decreased the patients’ complaints such as pain (P<0.001), pruritus (P=0.009), and discharge (P=0.010) effectively and meaningfully. Conclusion: Topical Alpha ointment was more effective on the healing of radiation-induced dermatitis than was topical hydrocortisone cream (1%) in our patients with breast cancer. Trial Registration Numbers: IRCT201206099979N1, ACTRN12612000837820 PMID:24293782

The Hydrodynamic Study of the Swimming Gliding: a Two-Dimensional Computational Fluid Dynamics (CFD) Analysis.

PubMed

Marinho, Daniel A; Barbosa, Tiago M; Rouboa, Abel I; Silva, António J

2011-09-01

Nowadays the underwater gliding after the starts and the turns plays a major role in the overall swimming performance. Hence, minimizing hydrodynamic drag during the underwater phases should be a main aim during swimming. Indeed, there are several postures that swimmers can assume during the underwater gliding, although experimental results were not conclusive concerning the best body position to accomplish this aim. Therefore, the purpose of this study was to analyse the effect in hydrodynamic drag forces of using different body positions during gliding through computational fluid dynamics (CFD) methodology. For this purpose, two-dimensional models of the human body in steady flow conditions were studied. Two-dimensional virtual models had been created: (i) a prone position with the arms extended at the front of the body; (ii) a prone position with the arms placed alongside the trunk; (iii) a lateral position with the arms extended at the front and; (iv) a dorsal position with the arms extended at the front. The drag forces were computed between speeds of 1.6 m/s and 2 m/s in a two-dimensional Fluent(®) analysis. The positions with the arms extended at the front presented lower drag values than the position with the arms aside the trunk. The lateral position was the one in which the drag was lower and seems to be the one that should be adopted during the gliding after starts and turns.

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

PubMed Central

Humphrey, Shannon; Rivers, Jason K.

2017-01-01

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

Comparing young people's experience of technology-delivered v. face-to-face mindfulness and relaxation: two-armed qualitative focus group study.

PubMed

Tunney, Conall; Cooney, Patricia; Coyle, David; O'Reilly, Gary

2017-04-01

Background The current popularity of mindfulness-based practices has coincided with the increase in access to mobile technology. This has led to many mindfulness apps and programs becoming available, some specifically for children. However, little is known about the experience of engaging with mindfulness through these mediums. Aims To explore children's experience of mindfulness delivered both face-to-face and through a computer game to highlight any differences or similarities. Method A two-armed qualitative focus groups design was used to explore children's experiences. The first arm offered mindfulness exercises in a traditional face-to-face setting with guided meditations. The second arm offered mindfulness exercises through a computer game avatar. Results Themes of relaxation, engagement, awareness, thinking, practice and directing attention emerged from both arms of focus groups. Subthematic codes highlight key differences as well as similarities in the experience of mindfulness. Conclusions These results indicate that mindfulness delivered via technology can offer a rich experience. © The Royal College of Psychiatrists 2017.

The BATTLE-2 Study: A Biomarker-Integrated Targeted Therapy Study in Previously Treated Patients With Advanced Non–Small-Cell Lung Cancer

PubMed Central

Lee, J. Jack; Wistuba, Ignacio I.; Tsao, Anne S.; Fossella, Frank V.; Kalhor, Neda; Gupta, Sanjay; Byers, Lauren Averett; Izzo, Julie G.; Gettinger, Scott N.; Goldberg, Sarah B.; Tang, Ximing; Miller, Vincent A.; Skoulidis, Ferdinandos; Gibbons, Don L.; Shen, Li; Wei, Caimiao; Diao, Lixia; Peng, S. Andrew; Wang, Jing; Tam, Alda L.; Coombes, Kevin R.; Koo, Ja Seok; Mauro, David J.; Rubin, Eric H.; Heymach, John V.; Hong, Waun Ki; Herbst, Roy S.

2016-01-01

Purpose By applying the principles of real-time biopsy, biomarker-based, adaptively randomized studies in non–small-cell lung cancer (NSCLC) established by the Biomarker-Integrated Approaches of Targeted Therapy for Lung Cancer Elimination (BATTLE) trial, we conducted BATTLE-2 (BATTLE-2 Program: A Biomarker-Integrated Targeted Therapy Study in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer), an umbrella study to evaluate the effects of targeted therapies focusing on KRAS-mutated cancers. Patients and Methods Patients with advanced NSCLC (excluding sensitizing EGFR mutations and ALK gene fusions) refractory to more than one prior therapy were randomly assigned, stratified by KRAS status, to four arms: (1) erlotinib, (2) erlotinib plus MK-2206, (3) MK-2206 plus AZD6244, or (4) sorafenib. Tumor gene expression profiling–targeted next-generation sequencing was performed to evaluate predictive and prognostic biomarkers. Results Two hundred patients, 27% with KRAS-mutated (KRAS mut+) tumors, were adaptively randomly assigned to erlotinib (n = 22), erlotinib plus MK-2206 (n = 42), MK-2206 plus AZD6244 (n = 75), or sorafenib (n = 61). In all, 186 patients were evaluable, and the primary end point of an 8-week disease control rate (DCR) was 48% (arm 1, 32%; arm 2, 50%; arm 3, 53%; and arm 4, 46%). For KRAS mut+ patients, DCR was 20%, 25%, 62%, and 44% whereas for KRAS wild-type patients, DCR was 36%, 57%, 49%, and 47% for arms 1, 2, 3, and 4, respectively. Median progression-free survival was 2.0 months, not different by KRAS status, 1.8 months for arm 1, and 2.5 months for arms 2 versus arms 3 and 4 in KRAS mut+ patients (P = .04). Median overall survival was 6.5 months, 9.0 and 5.1 months for arms 1 and 2 versus arms 3 and 4 in KRAS wild-type patients (P = .03). Median overall survival was 7.5 months in mesenchymal versus 5 months in epithelial tumors (P = .02). Conclusion Despite improved progression-free survival on therapy that did not contain erlotinib for KRAS mut+ patients and improved prognosis for mesenchymal tumors, better biomarker-driven treatment strategies are still needed. PMID:27480147

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

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

PubMed Central

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

2011-01-01

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

Prostate implant reconstruction from C-arm images with motion-compensated tomosynthesis

PubMed Central

Dehghan, Ehsan; Moradi, Mehdi; Wen, Xu; French, Danny; Lobo, Julio; Morris, W. James; Salcudean, Septimiu E.; Fichtinger, Gabor

2011-01-01

Purpose: Accurate localization of prostate implants from several C-arm images is necessary for ultrasound-fluoroscopy fusion and intraoperative dosimetry. The authors propose a computational motion compensation method for tomosynthesis-based reconstruction that enables 3D localization of prostate implants from C-arm images despite C-arm oscillation and sagging. Methods: Five C-arm images are captured by rotating the C-arm around its primary axis, while measuring its rotation angle using a protractor or the C-arm joint encoder. The C-arm images are processed to obtain binary seed-only images from which a volume of interest is reconstructed. The motion compensation algorithm, iteratively, compensates for 2D translational motion of the C-arm by maximizing the number of voxels that project on a seed projection in all of the images. This obviates the need for C-arm full pose tracking traditionally implemented using radio-opaque fiducials or external trackers. The proposed reconstruction method is tested in simulations, in a phantom study and on ten patient data sets. Results: In a phantom implanted with 136 dummy seeds, the seed detection rate was 100% with a localization error of 0.86 ± 0.44 mm (Mean ± STD) compared to CT. For patient data sets, a detection rate of 99.5% was achieved in approximately 1 min per patient. The reconstruction results for patient data sets were compared against an available matching-based reconstruction method and showed relative localization difference of 0.5 ± 0.4 mm. Conclusions: The motion compensation method can successfully compensate for large C-arm motion without using radio-opaque fiducial or external trackers. Considering the efficacy of the algorithm, its successful reconstruction rate and low computational burden, the algorithm is feasible for clinical use. PMID:21992346

Association of Inter-Arm Systolic Blood Pressure Difference with Coronary Atherosclerotic Disease Burden Using Calcium Scoring

PubMed Central

Her, Ae-Young; Cho, Kyoung-Im; Garg, Scot; Kim, Yong Hoon

2017-01-01

Purpose There are no sufficient data on the correlation between inter-arm blood pressure (BP) difference and coronary atherosclerosis found using coronary artery calcium score (CACS). We aimed to investigate if the increased difference in inter-arm BP is independently associated with severity of CACS. Materials and Methods Patients who had ≥3 cardiovascular risk factors or an intermediate Framingham Risk Score (FRS; ≥10) were enrolled. Inter-arm BP difference was defined as the absolute difference in BP in both arms. Quantitative CACS was measured by using coronary computed tomography angiography with the scoring system. Results A total of 261 patients were included in this study. Age (r=0.256, p<0.001), serum creatinine (r=0.139, p=0.030), mean of right arm systolic BP (SBP; r=0.172, p=0.005), mean of left arm SBP (r=0.190, p=0.002), inter-arm SBP difference (r=0.152, p=0.014), and the FRS (r=0.278, p<0.001) showed significant correlation with CACS. The increased inter-arm SBP difference (≥6 mm Hg) was significantly associated with CACS ≥300 [odds ratio (OR) 2.17, 95% confidence interval (CI) 1.12–4.22; p=0.022]. In multivariable analysis, the inter-arm SBP difference ≥6 mm Hg was also significantly associated with CACS ≥300 after adjusting for clinical risk factors (OR 2.34, 95 % CI 1.06–5.19; p=0.036). Conclusion An increased inter-arm SBP difference (≥6 mm Hg) is associated with coronary atherosclerotic disease burden using CACS, and provides additional information for predicting severe coronary calcification, compared to models based on traditional risk factors. PMID:28792138

Relationship between Arm Morbidity and Patient-Reported Outcomes Following Surgery in Women with Node-Negative Breast Cancer: NSABP Protocol B-32

PubMed Central

Kopec, Jacek A.; Colangelo, Linda H.; Land, Stephanie R.; Julian, Thomas B.; Brown, Ann M.; Anderson, Stewart J.; Krag, David N.; Ashikaga, Takamaru; Costantino, Joseph P.; Wolmark, Norman; Ganz, Patricia A.

2012-01-01

Background The impact of arm morbidity following breast cancer surgery on patient-observed changes in daily functioning and health-related quality of life (HRQoL) have not been well-studied. Objective To examine the association of objective measures such as range of motion (ROM) and lymphedema, with patient-reported outcomes (PROs) in the arm and breast, upper extremity function, activities, and HRQoL. Methods The National Surgical Adjuvant Breast and Bowel Project Protocol B-32 was a randomized trial comparing sentinel node resection (SNR) with axillary dissection (AD) in women with node-negative breast cancer. ROM and arm volume were measured objectively. PROs included symptoms; arm function; limitations in social, recreational, occupational, and other regular activities; and a global index of HRQoL. Statistical methods included cross-tabulations and multivariable linear regression models. Results In all, 744 women provided at least 1 postsurgery assessment. About one-third of the patients experienced arm mobility restrictions. A similar number of patients avoided the use of the arm 6 months after surgery. Limitations in work and other regular activities were reported by about a quarter of the patients. In this multivariable analysis, arm mobility and sensory neuropathy were predictors of patient-reported arm function and overall HRQoL. Predictors for activity limitations also included side of surgery (dominant vs nondominant). Edema was not significant after adjustment for sensory neuropathy and ROM. Limitations Arm mobility and edema were measured simultaneously only once during the follow-up (6 months). Conclusion Clinical measures of sensory neuropathy and restrictions in arm mobility following breast cancer surgery are associated with self-reported limitations in activity and reductions in overall HRQoL. PMID:22951047

Shoulder pain and concomitant hand oedema among stroke patients with pronounced arm paresis

PubMed Central

2013-01-01

Background The aim of this prospective study was to identify clinical factors associated with the development of shoulder pain in stroke patients with pronounced arm paresis. Methods At stroke onset, 485 patients were initially assessed in 2007–2009. Sixty-three patients with pronounced arm paresis completed the study, and 21 of these developed shoulder pain. Clinical findings were recorded fortnightly by the attending physiotherapist during hospital stay. Results Hand oedema on the paretic side was more common in patients developing shoulder pain compared with those who did not develop shoulder pain. The onset of shoulder pain was associated with concomitant hand oedema. High NIHSS score was associated with developing shoulder pain. Patients with a history of shoulder pain developed pain earlier than those without previous shoulder pain. Patients with haemorrhagic stroke were significantly more prone to developing shoulder pain. Conclusions One-third of the stroke patients with pronounced arm paresis developed shoulder pain. Concomitant hand oedema seems to be an additional symptom of shoulder injury. Patients with low general status are more vulnerable to develop post-stroke shoulder pain. PMID:24765589

Sex-Related Differences in Scapular Kinematics During Elevation of the Arm in Asymptomatic Children and Adults.

PubMed

Habechian, Fernanda Assis Paes; Rosa, Dayana Patricia; Haik, Melina Nevoeiro; Camargo, Paula Rezende

2016-10-01

Recently, it has been suggested that sex may influence scapular kinematics. A more comprehensive analysis of the scapular kinematics in children and adults, including sex as a factor, will help to understand if differences between sexes are present since childhood. The purpose of this study was to compare scapular kinematics between sex in children and adults during elevation of the arm. One-hundred and sixteen asymptomatic adults (58 men and 58 women) and 53 children (28 boys and 25 girls) participated in the study. Three-dimensional scapular kinematics during elevation of the arm were obtained using an electromagnetic tracking device. Women had a more upwardly rotated scapula in the nondominant side (P < .05), with large effects and a more anteriorly tilted position at 60°, 90°, and 120° of arm elevation in the dominant side, and at 90° and 120° in the nondominant side (P < .05) with moderate effects when compared with men. Differences between sexes were not found in the children (P > .05). In conclusion, sex seems to influence scapular kinematics in adulthood, but not in childhood.

A review of bilateral training for upper extremity hemiparesis.

PubMed

Stoykov, Mary Ellen; Corcos, Daniel M

2009-01-01

Upper extremity hemiparesis is the most common post-stroke disability. Longitudinal studies have indicated that 30-66% of stroke survivors do not have full arm function 6 months post-stroke. The current gold standard for treatment of mild post-stroke upper limb impairment is constraint-induced therapy but, because of the inclusion criteria, alternative treatments are needed which target more impaired subjects. Bilateral arm training has been investigated as a potential rehabilitation intervention. Bilateral arm training encompasses a number of methods including: (1) bilateral isokinematic training; (2) mirror therapy using bilateral training; (3) device-driven bilateral training; and (4) bilateral motor priming. Neural mechanisms mediating bilateral training are first reviewed. The key bilateral training studies that have demonstrated evidence of efficacy will then be discussed. Finally, conclusions are drawn concerning clinical implications based on the reviewed literature. (c) 2009 John Wiley & Sons, Ltd.

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

PubMed Central

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

2014-01-01

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

Alcohol Electronic Screening and Brief Intervention: A Community Guide Systematic Review

PubMed Central

Tansil, Kristin A.; Esser, Marissa B.; Sandhu, Paramjit; Reynolds, Jeffrey A.; Elder, Randy W.; Williamson, Rebecca S.; Chattopadhyay, Sajal K.; Bohm, Michele K.; Brewer, Robert D.; McKnight-Eily, Lela R.; Hungerford, Daniel W.; Toomey, Traci L.; Hingson, Ralph W.; Fielding, Jonathan E.

2016-01-01

Context Excessive drinking is responsible for 1 in 10 deaths among working-age adults in the U.S. annually. Alcohol screening and brief intervention (ASBI) is an effective, but underutilized, intervention for reducing excessive drinking among adults. Electronic screening and brief intervention (e-SBI) uses electronic devices to deliver key elements of ASBI, and has the potential to expand population reach. Evidence acquisition Using Community Guide methods, a systematic review of the scientific literature on the effectiveness of e-SBI for reducing excessive alcohol consumption and related harms was conducted. The search covered studies published from 1967 to October 2011. A total of 31 studies with 36 study arms met quality criteria, and were included in the review. Analyses were conducted in 2012. Evidence synthesis Twenty-four studies (28 study arms) provided results for excessive drinkers only and seven studies (eight study arms) reported results for all drinkers. Nearly all studies found that e-SBI reduced excessive alcohol consumption and related harms: nine study arms reported a median 23.9% reduction in binge drinking intensity (maximum drinks/binge episode) and nine study arms reported a median 16.5% reduction in binge drinking frequency. Reductions in drinking measures were sustained for up to 12 months. Conclusion According to Community Guide rules of evidence, e-SBI is an effective method for reducing excessive alcohol consumption and related harms among intervention participants. Implementation of e-SBI could complement population-level strategies previously recommended by the Community Preventive Services Task Force for reducing excessive drinking (e.g., increasing alcohol taxes and regulating alcohol outlet density). PMID:27745678

Reduced activation in the ventral striatum during probabilistic decision-making in patients in an at-risk mental state

PubMed Central

Rausch, Franziska; Mier, Daniela; Eifler, Sarah; Fenske, Sabrina; Schirmbeck, Frederike; Englisch, Susanne; Schilling, Claudia; Meyer-Lindenberg, Andreas; Kirsch, Peter; Zink, Mathias

2015-01-01

Background Patients with schizophrenia display metacognitive impairments, such as hasty decision-making during probabilistic reasoning — the “jumping to conclusion” bias (JTC). Our recent fMRI study revealed reduced activations in the right ventral striatum (VS) and the ventral tegmental area (VTA) to be associated with decision-making in patients with schizophrenia. It is unclear whether these functional alterations occur in the at-risk mental state (ARMS). Methods We administered the classical beads task and fMRI among ARMS patients and healthy controls matched for age, sex, education and premorbid verbal intelligence. None of the ARMS patients was treated with antipsychotics. Both tasks request probabilistic decisions after a variable amount of stimuli. We evaluated activation during decision-making under certainty versus uncertainty and the process of final decision-making. Results We included 24 AMRS patients and 24 controls in our study. Compared with controls, ARMS patients tended to draw fewer beads and showed significantly more JTC bias in the classical beads task, mirroring findings in patients with schizophrenia. During fMRI, ARMS patients did not demonstrate JTC bias on the behavioural level, but showed a significant hypoactivation in the right VS during the decision stage. Limitations Owing to the cross-sectional design of the study, results are constrained to a better insight into the neurobiology of risk constellations, but not pre-psychotic stages. Nine of the ARMS patients were treated with antidepressants and/or lorazepam. Conclusion As in patients with schizophrenia, a striatal hypoactivation was found in ARMS patients. Confounding effects of antipsychotic medication can be excluded. Our findings indicate that error prediction signalling and reward anticipation may be linked to striatal dysfunction during prodromal stages and should be examined for their utility in predicting transition risk. PMID:25622039

Reduced activation in the ventral striatum during probabilistic decision-making in patients in an at-risk mental state.

PubMed

Rausch, Franziska; Mier, Daniela; Eifler, Sarah; Fenske, Sabrina; Schirmbeck, Frederike; Englisch, Susanne; Schilling, Claudia; Meyer-Lindenberg, Andreas; Kirsch, Peter; Zink, Mathias

2015-05-01

Patients with schizophrenia display metacognitive impairments, such as hasty decision-making during probabilistic reasoning - the "jumping to conclusion" bias (JTC). Our recent fMRI study revealed reduced activations in the right ventral striatum (VS) and the ventral tegmental area (VTA) to be associated with decision-making in patients with schizophrenia. It is unclear whether these functional alterations occur in the at-risk mental state (ARMS). We administered the classical beads task and fMRI among ARMS patients and healthy controls matched for age, sex, education and premorbid verbal intelligence. None of the ARMS patients was treated with antipsychotics. Both tasks request probabilistic decisions after a variable amount of stimuli. We evaluated activation during decision-making under certainty versus uncertainty and the process of final decision-making. We included 24 AMRS patients and 24 controls in our study. Compared with controls, ARMS patients tended to draw fewer beads and showed significantly more JTC bias in the classical beads task, mirroring findings in patients with schizophrenia. During fMRI, ARMS patients did not demonstrate JTC bias on the behavioural level, but showed a significant hypoactivation in the right VS during the decision stage. Owing to the cross-sectional design of the study, results are constrained to a better insight into the neurobiology of risk constellations, but not prepsychotic stages. Nine of the ARMS patients were treated with antidepressants and/or lorazepam. As in patients with schizophrenia, a striatal hypoactivation was found in ARMS patients. Confounding effects of antipsychotic medication can be excluded. Our findings indicate that error prediction signalling and reward anticipation may be linked to striatal dysfunction during prodromal stages and should be examined for their utility in predicting transition risk.

Inflammation in benign prostate tissue and prostate cancer in the finasteride arm of the Prostate Cancer Prevention Trial*

PubMed Central

Murtola, Teemu J.; Gurel, Bora; Umbehr, Martin; Lucia, M. Scott; Thompson, Ian M.; Goodman, Phyllis J.; Kristal, Alan R.; Parnes, Howard L.; Lippman, Scott M.; Sutcliffe, Siobhan; Peskoe, Sarah B.; Barber, John R.; Drake, Charles G.; Nelson, William G.; De Marzo, Angelo M.; Platz, Elizabeth A.

2015-01-01

Background A previous analysis of the placebo arm of the Prostate Cancer Prevention Trial (PCPT) reported 82% overall prevalence of intraprostatic inflammation and identified a link between inflammation and higher-grade prostate cancer and serum PSA. Here we studied these associations in the PCPT finasteride arm. Methods Prostate cancer cases (N=197) detected either on a clinically indicated biopsy or on protocol-directed end-of-study biopsy, and frequency-matched controls (N=248) with no cancer on an end-of-study biopsy were sampled from the finasteride arm. Inflammation in benign prostate tissue was visually assessed using digital images of H&E stained sections. Logistic regression was used for statistical analysis. Results In the finasteride arm, 91.6% of prostate cancer cases and 92.4% of controls had at least one biopsy core with inflammation in benign areas; p < 0.001 for difference compared to placebo arm. Overall, the odds of prostate cancer did not differ by prevalence (OR=0.90, 95% CI 0.44-1.84) or extent (P-trend=0.68) of inflammation. Inflammation was not associated with higher-grade disease (prevalence: OR=1.07, 95% CI 0.43-2.69). Furthermore, mean PSA concentration did not differ by the prevalence or extent of inflammationin either cases or controls. Conclusion The prevalence of intraprostatic inflammation was higher in the finasteride than placebo arm of the PCPT, with no association with higher-grade prostate cancer. Impact Finasteride may attenuate the association between inflammation and higher-grade prostate cancer. Moreover, the missing link between intraprostatic inflammation and PSA suggests that finasteride may reduce inflammation-associated PSA elevation. PMID:26715424

Efficacy and Safety of Low-Dose-Rate Endorectal Brachytherapy as a Boost to Neoadjuvant Chemoradiation in the Treatment of Locally Advanced Distal Rectal Cancer: A Phase-II Clinical Trial

PubMed Central

Omidvari, Shapour; Zohourinia, Shadi; Ansari, Mansour; Ghahramani, Leila; Zare-Bandamiri, Mohammad; Mosalaei, Ahmad; Ahmadloo, Niloofar; Pourahmad, Saeedeh; Nasrolahi, Hamid; Hamedi, Sayed Hasan

2015-01-01

Purpose Despite advances in rectal cancer treatment over the last decade, local control and risk of late side effects due to external beam radiation therapy (EBRT) remain as concerns. The present study aimed to investigate the efficacy and the safety of low-dose-rate endorectal brachytherapy (LDRBT) as a boost to neoadjuvant chemoradiation for use in treating locally advanced distal rectal adenocarcinomas. Methods This phase-II clinical trial included 34 patients (as the study arm) with newly diagnosed, locally advanced (clinical T3-T4 and/or N1/N2, M0) lower rectal cancer. For comparative analysis, 102 matched patients (as the historical control arm) with rectal cancer were also selected. All the patients were treated with LDRBT (15 Gy in 3 fractions) and concurrent chemoradiation (45-50.4 Gy). Concurrent chemotherapy consisted of oxaliplatin 130 mg/m2 intravenously on day 1 plus oral capecitabine 825 mg/m2 twice daily during LDRBT and EBRT. Results The study results revealed a significant differences between the study arm and the control arm in terms in the pathologic tumor size (2.1 cm vs. 3.6 cm, P = 0.001), the pathologic tumor stage (35% T3-4 vs. 65% T3-4, P = 0.003), and the pathologic complete response (29.4% vs. 11.7%, P < 0.028). Moreover, a significantly higher dose of EBRT (P = 0.041) was found in the control arm, and a longer time to surgery was observed in the study arm (P < 0.001). The higher rate of treatment-related toxicities, such as mild proctitis and anemia, in the study arm was tolerable and easily manageable. Conclusion A boost of LDRBT can optimize the pathologic complete response, with acceptable toxicities, in patients with distal rectal cancer. PMID:26361613

Inter-arm blood pressure differences compared with ambulatory monitoring: a manifestation of the ‘white-coat’ effect?

PubMed Central

Martin, Una; Holder, Roger; Hodgkinson, James; McManus, Richard

2013-01-01

Background Inter-arm difference in blood pressure of >10 mmHg is associated with peripheral vascular disease, but it is unclear how much of the difference in sequential right and left arm blood pressure measurements might be due to a ‘white-coat’ effect. Aim To use ambulatory blood pressure monitoring (ABPM) to better understand the clinical significance of inter-arm differences in blood pressure. Design and setting Retrospective study in a teaching hospital in Birmingham. Method Anonymised clinical data collected from 784 patients attending a single hospital-based hypertension clinic were retrospectively analysed. Each participant had blood pressure measured sequentially in both arms, followed by ABPM over the subsequent 24 hours. Result Data were available for 710 (91%) patients, of whom 39.3% (279) had a blood pressure difference of 10 mmHg or more between each arm. Compared to daytime systolic ABPM, the difference was 25.1 mmHg using the arm with the highest reading, but only 15.5 mmHg if the lower reading was taken (mean difference 9.6 mmHg (95% confidence interval [CI] = 9.0 mmHg to 10.3 mmHg)). However, differences between mean right (20.7 mmHg) or left (19.9 mmHg) arm blood pressure and daytime systolic ABPM were very similar. Conclusion Compared with ABPM, use of the higher of the left and right arm readings measured sequentially appears to overestimate true mean blood pressure. As there is no significant difference in the extent of disparity with ABPM by left or right arm, this is unlikely to be due to arm dominance and may be due to the ‘white-coat’ effect reducing blood pressure on repeated measurement. Where a large inter-arm blood pressure difference is detected with sequential measurement, healthcare professionals should re-measure the blood pressure in the original arm. PMID:23561681

Dummy Run of Quality Assurance Program in a Phase 3 Randomized Trial Investigating the Role of Internal Mammary Lymph Node Irradiation in Breast Cancer Patients: Korean Radiation Oncology Group 08-06 Study

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

Chung, Yoonsun; Kim, Jun Won; Shin, Kyung Hwan

2015-02-01

Purpose: The Korean Radiation Oncology Group (KROG) 08-06 study protocol allowed radiation therapy (RT) technique to include or exclude breast cancer patients from receiving radiation therapy to the internal mammary lymph node (IMN). The purpose of this study was to assess dosimetric differences between the 2 groups and potential influence on clinical outcome by a dummy run procedure. Methods and Materials: All participating institutions were asked to produce RT plans without irradiation (Arm 1) and with irradiation to the IMN (Arm 2) for 1 breast-conservation treatment case (breast-conserving surgery [BCS]) and 1 mastectomy case (modified radical mastectomy [MRM]) whose computed tomographymore » images were provided. We assessed interinstitutional variations in IMN delineation and evaluated the dose-volume histograms of the IMN and normal organs. A reference IMN was delineated by an expert panel group based on the study guidelines. Also, we analyzed the potential influence of actual dose variation observed in this study on patient survival. Results: Although physicians intended to exclude the IMN within the RT field, the data showed almost 59.0% of the prescribed dose was delivered to the IMN in Arm 1. However, the mean doses covering the IMN in Arm 1 and Arm 2 were significantly different for both cases (P<.001). Due to the probability of overdose in Arm 1, the estimated gain in 7-year disease-free survival rate would be reduced from 10% to 7.9% for BCS cases and 7.1% for MRM cases. The radiation doses to the ipsilateral lung, heart, and coronary artery were lower in Arm 1 than in Arm 2. Conclusions: Although this dummy run study indicated that a substantial dose was delivered to the IMN, even in the nonirradiation group, the dose differences between the 2 groups were statistically significant. However, this dosimetric profile should be studied further with actual patient samples and be taken into consideration when analyzing clinical outcomes according to IMN irradiation.« less

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

PubMed Central

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

2012-01-01

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

Association of objectively measured arm inclination with shoulder pain: A 6-month follow-up prospective study of construction and health care workers

PubMed Central

Koch, Markus; Lunde, Lars-Kristian; Veiersted, Kaj Bo; Knardahl, Stein

2017-01-01

Objectives The aim was to determine the association of occupational arm inclination with shoulder pain in construction and health care workers. Methods Arm inclination relative to the vertical was measured with an accelerometer placed on the dominant upper arm for up to four full days at baseline in 62 construction workers and 63 health care workers. The pain intensity in the shoulder and mechanical and psychosocial work factors were measured by self-reports at baseline and prospectively after 6 months. The associations between exposures and shoulder pain were analyzed with multilevel mixed-effects linear regressions. Results For the total study population working with the dominant arm at inclinations > 30° and >120° was associated with lower levels of shoulder pain both cross-sectionally and after 6 months. Associations were attenuated when adjusting for individual and social factors, psychological state, and exposure during leisure time, especially for the high inclination levels. Analyses, only including subjects with no pain at baseline revealed no significant associations. While stratified analysis showed negative associations in the construction worker group, there were no significant association in health care workers. Compared to the number of hypotheses tested, the number of significant findings was low. Adjustment by Bonferroni-correction made almost all findings insignificant. Conclusions All analyses reflected a negative association between arm inclination and shoulder pain, but few analyses showed these associations to be statistically significant. If there is a relationship between arm inclination and shoulder pain, these findings could indicate that pain-avoidance may modify how workers perform their tasks. PMID:29176761

Economic evaluation of a task-shifting intervention for common mental disorders in India

PubMed Central

Buttorff, Christine; Hock, Rebecca S; Weiss, Helen A; Naik, Smita; Araya, Ricardo; Kirkwood, Betty R; Chisholm, Daniel

2012-01-01

Abstract Objective To carry out an economic evaluation of a task-shifting intervention for the treatment of depressive and anxiety disorders in primary-care settings in Goa, India. Methods Cost–utility and cost–effectiveness analyses based on generalized linear models were performed within a trial set in 24 public and private primary-care facilities. Subjects were randomly assigned to an intervention or a control arm. Eligible subjects in the intervention arm were given psycho-education, case management, interpersonal psychotherapy and/or antidepressants by lay health workers. Subjects in the control arm were treated by physicians. The use of health-care resources, the disability of each subject and degree of psychiatric morbidity, as measured by the Revised Clinical Interview Schedule, were determined at 2, 6 and 12 months. Findings Complete data, from all three follow-ups, were collected from 1243 (75.4%) and 938 (81.7%) of the subjects enrolled in the study facilities from the public and private sectors, respectively. Within the public facilities, subjects in the intervention arm showed greater improvement in all the health outcomes investigated than those in the control arm. Time costs were also significantly lower in the intervention arm than in the control arm, whereas health system costs in the two arms were similar. Within the private facilities, however, the effectiveness and costs recorded in the two arms were similar. Conclusion Within public primary-care facilities in Goa, the use of lay health workers in the care of subjects with common mental disorders was not only cost–effective but also cost-saving. PMID:23226893

Trial of Early Aggressive Therapy in Polyarticular Juvenile Idiopathic Arthritis

PubMed Central

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

2011-01-01

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

An Interlaminar Tensile Strength Specimen

NASA Technical Reports Server (NTRS)

Martin, Roderick H.; Jackson, Wade C.

1993-01-01

This paper describes a technique to determine interlaminar tensile strength, sigma(sub 3c), of a fiber reinforced composite material using a curved beam. The specimen was a unidirectional curved beam, bent 90 deg, with straight arms. Attached to each arm was a hinged loading mechanism that was held by the grips of a tension testing machine. Geometry effects of the specimen, including the effects of loading arm length, inner radius, thickness, and width, were studied. The data sets fell into two categories: low strength corresponding to a macroscopic flaw related failure and high strength corresponding to a microscopic flaw related failure. From the data available, the specimen width and loading arm length had little effect on sigma(sub 3c). The inner radius was not expected to have a significant effect on sigma(sub 3c), but this conclusion could not be confirmed because of differences in laminate quality for each curve geometry. The thicker specimens had the lowest value of sigma(sub 3c) because of poor laminate quality.

A cluster randomized trial to assess the effect of clinical pathways for patients with stroke: results of the clinical pathways for effective and appropriate care study

PubMed Central

2012-01-01

Background Clinical pathways (CPs) are used to improve the outcomes of acute stroke, but their use in stroke care is questionable, because the evidence on their effectiveness is still inconclusive. The objective of this study was to evaluate whether CPs improve the outcomes and the quality of care provided to patients after acute ischemic stroke. Methods This was a multicentre cluster-randomized trial, in which 14 hospitals were randomized to the CP arm or to the non intervention/usual care (UC) arm. Healthcare workers in the CP arm received 3 days of training in quality improvement of CPs and in use of a standardized package including information on evidence-based key interventions and indicators. Healthcare workers in the usual-care arm followed their standard procedures. The teams in the CP arm developed their CPs over a 6-month period. The primary end point was mortality. Secondary end points were: use of diagnostic and therapeutic procedures, implementation of organized care, length of stay, re-admission and institutionalization rates after discharge, dependency levels, and complication rates. Results Compared with the patients in the UC arm, the patients in the CP arm had a significantly lower risk of mortality at 7 days (OR = 0.10; 95% CI 0.01 to 0.95) and significantly lower rates of adverse functional outcomes, expressed as the odds of not returning to pre-stroke functioning in their daily life (OR = 0.42; 95 CI 0.18 to 0.98). There was no significant effect on 30-day mortality. Compared with the UC arm, the hospital diagnostic and therapeutic procedures were performed more appropriately in the CP arm, and the evidence-based key interventions and organized care were more applied in the CP arm. Conclusions CPs can significantly improve the outcomes of patients with ischemic patients with stroke, indicating better application of evidence-based key interventions and of diagnostic and therapeutic procedures. This study tested a new hypothesis and provided evidence on how CPs can work. Trial registration ClinicalTrials.gov ID: [NCT00673491]. PMID:22781160

Screened selection design for randomised phase II oncology trials: an example in chronic lymphocytic leukaemia

PubMed Central

2013-01-01

Background As there are limited patients for chronic lymphocytic leukaemia trials, it is important that statistical methodologies in Phase II efficiently select regimens for subsequent evaluation in larger-scale Phase III trials. Methods We propose the screened selection design (SSD), which is a practical multi-stage, randomised Phase II design for two experimental arms. Activity is first evaluated by applying Simon’s two-stage design (1989) on each arm. If both are active, the play-the-winner selection strategy proposed by Simon, Wittes and Ellenberg (SWE) (1985) is applied to select the superior arm. A variant of the design, Modified SSD, also allows the arm with the higher response rates to be recommended only if its activity rate is greater by a clinically-relevant value. The operating characteristics are explored via a simulation study and compared to a Bayesian Selection approach. Results Simulations showed that with the proposed SSD, it is possible to retain the sample size as required in SWE and obtain similar probabilities of selecting the correct superior arm of at least 90%; with the additional attractive benefit of reducing the probability of selecting ineffective arms. This approach is comparable to a Bayesian Selection Strategy. The Modified SSD performs substantially better than the other designs in selecting neither arm if the underlying rates for both arms are desirable but equivalent, allowing for other factors to be considered in the decision making process. Though its probability of correctly selecting a superior arm might be reduced, it still performs reasonably well. It also reduces the probability of selecting an inferior arm. Conclusions SSD provides an easy to implement randomised Phase II design that selects the most promising treatment that has shown sufficient evidence of activity, with available R codes to evaluate its operating characteristics. PMID:23819695

Clinical and MRI activity as determinants of sample size for pediatric multiple sclerosis trials

PubMed Central

Verhey, Leonard H.; Signori, Alessio; Arnold, Douglas L.; Bar-Or, Amit; Sadovnick, A. Dessa; Marrie, Ruth Ann; Banwell, Brenda

2013-01-01

Objective: To estimate sample sizes for pediatric multiple sclerosis (MS) trials using new T2 lesion count, annualized relapse rate (ARR), and time to first relapse (TTFR) endpoints. Methods: Poisson and negative binomial models were fit to new T2 lesion and relapse count data, and negative binomial time-to-event and exponential models were fit to TTFR data of 42 children with MS enrolled in a national prospective cohort study. Simulations were performed by resampling from the best-fitting model of new T2 lesion count, number of relapses, or TTFR, under various assumptions of the effect size, trial duration, and model parameters. Results: Assuming a 50% reduction in new T2 lesions over 6 months, 90 patients/arm are required, whereas 165 patients/arm are required for a 40% treatment effect. Sample sizes for 2-year trials using relapse-related endpoints are lower than that for 1-year trials. For 2-year trials and a conservative assumption of overdispersion (ϑ), sample sizes range from 70 patients/arm (using ARR) to 105 patients/arm (TTFR) for a 50% reduction in relapses, and 230 patients/arm (ARR) to 365 patients/arm (TTFR) for a 30% relapse reduction. Assuming a less conservative ϑ, 2-year trials using ARR require 45 patients/arm (60 patients/arm for TTFR) for a 50% reduction in relapses and 145 patients/arm (200 patients/arm for TTFR) for a 30% reduction. Conclusion: Six-month phase II trials using new T2 lesion count as an endpoint are feasible in the pediatric MS population; however, trials powered on ARR or TTFR will need to be 2 years in duration and will require multicentered collaboration. PMID:23966255

A Randomized Phase 2 Study Comparing 2 Stereotactic Body Radiation Therapy Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer: NRG Oncology RTOG 0915 (NCCTG N0927)

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

Videtic, Gregory M.M., E-mail: videtig@ccf.org; Hu, Chen; Johns Hopkins University School of Medicine, Baltimore, Maryland

Purpose: To compare 2 stereotactic body radiation therapy (SBRT) schedules for medically inoperable early-stage lung cancer to determine which produces the lowest rate of grade ≥3 protocol-specified adverse events (psAEs) at 1 year. Methods and Materials: Patients with biopsy-proven peripheral (≥2 cm from the central bronchial tree) T1 or T2, N0 (clinically node negative by positron emission tomography), M0 tumors were eligible. Patients were randomized to receive either 34 Gy in 1 fraction (arm 1) or 48 Gy in 4 consecutive daily fractions (arm 2). Rigorous central accreditation and quality assurance confirmed treatment per protocol guidelines. This study was designed to detect a psAEsmore » rate >17% at a 10% significance level (1-sided) and 90% power. Secondary endpoints included rates of primary tumor control (PC), overall survival (OS), and disease-free survival (DFS) at 1 year. Designating the better of the 2 regimens was based on prespecified rules of psAEs and PC for each arm. Results: Ninety-four patients were accrued between September 2009 and March 2011. The median follow-up time was 30.2 months. Of 84 analyzable patients, 39 were in arm 1 and 45 in arm 2. Patient and tumor characteristics were balanced between arms. Four (10.3%) patients on arm 1 (95% confidence interval [CI] 2.9%-24.2%) and 6 (13.3%) patients on arm 2 (95% CI 5.1%-26.8%) experienced psAEs. The 2-year OS rate was 61.3% (95% CI 44.2%-74.6%) for arm 1 patients and 77.7% (95% CI 62.5%-87.3%) for arm 2. The 2-year DFS was 56.4% (95% CI 39.6%-70.2%) for arm 1 and 71.1% (95% CI 55.5%-82.1%) for arm 2. The 1-year PC rate was 97.0% (95% CI 84.2%-99.9%) for arm 1 and 92.7% (95% CI 80.1%-98.5%) for arm 2. Conclusions: 34 Gy in 1 fraction met the prespecified criteria and, of the 2 schedules, warrants further clinical research.« less

A cluster randomised feasibility study of an adolescent incentive intervention to increase uptake of HPV vaccination

PubMed Central

Forster, Alice S; Cornelius, Victoria; Rockliffe, Lauren; Marlow, Laura AV; Bedford, Helen; Waller, Jo

2017-01-01

Background: Uptake of human papillomavirus (HPV) vaccination is suboptimal among some groups. We aimed to determine the feasibility of undertaking a cluster randomised controlled trial (RCT) of incentives to improve HPV vaccination uptake by increasing consent form return. Methods: An equal-allocation, two-arm cluster RCT design was used. We invited 60 London schools to participate. Those agreeing were randomised to either a standard invitation or incentive intervention arm, in which Year 8 girls had the chance to win a £50 shopping voucher if they returned a vaccination consent form, regardless of whether consent was provided. We collected data on school and parent participation rates and questionnaire response rates. Analyses were descriptive. Results: Six schools completed the trial and only 3% of parents opted out. The response rate was 70% for the girls’ questionnaire and 17% for the parents’. In the intervention arm, 87% of girls returned a consent form compared with 67% in the standard invitation arm. The proportion of girls whose parents gave consent for vaccination was higher in the intervention arm (76%) than the standard invitation arm (61%). Conclusions: An RCT of an incentive intervention is feasible. The intervention may improve vaccination uptake but a fully powered RCT is needed. PMID:28829766

Work related risk factors for musculoskeletal complaints in the spinning industry in Lithuania

PubMed Central

Gamperiene, M.; Stigum, H.

1999-01-01

OBJECTIVES: To describe the prevalence of self reported musculoskeletal complaints in the back, arms or neck, and legs among workers in the spinning industry, and to investigate the relations between these complaints and work related variables. METHODS: An interview based questionnaire survey was carried out in two spinning industry factories in Lithuania. RESULTS: The study group consisted of all workers in production (n = 363). Symptoms of the legs were the musculoskeletal symptom reported most often (61%). Many subjects had arms or neck (55%) or back problems (28%). 20% had experienced pain from all three sites. Almost 25% had had musculoskeletal pain every day and 16% had experienced constant pain during previous year. Packers had the highest risk of arms or neck problems whereas spinners had the highest risk of back or leg problems. Working in a strained posture (bending, work with arms raised up above shoulder level, and repetitive movements of the fingers) was associated with all three complaints. Only arms or neck complaints were associated with age. CONCLUSIONS: Musculoskeletal disorders are a common problem among workers producing gobelin or synthetic thread in Lithuania and working in a strained posture is a risk factor for developing musculoskeletal disorders in three body sites: legs, arms or neck, and back. To better understand the different aspects of physical load as risk factors, a more detailed study of the frequency of postural changes as well as an observation of individually adopted postures would be necessary. This applies to intervention studies in factories of the spinning industry to prevent complaints of the legs and shoulders.   PMID:10474538

Patient-Reported Outcomes in a Phase III Study of Everolimus Versus Placebo in Patients with Metastatic Carcinoma of the Kidney That Has Progressed on Vascular Endothelial Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy

PubMed Central

Butt, Zeeshan; Baladi, Jeanfrancois; Motzer, Robert J.; Haas, Tomas; Hollaender, Norbert; Kay, Andrea; Cella, David

2011-01-01

Purpose. A phase III, randomized, double-blind, placebo-controlled trial was conducted in patients with metastatic renal cell carcinoma. The focus of this paper is to evaluate the patient-reported outcomes. Methods. Patients were randomly assigned (2:1) to receive oral everolimus 10 mg once daily or placebo. The Functional Assessment of Cancer Therapy Kidney Symptom Index—Disease-Related Symptoms (FKSI-DRS) and European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 were administered before randomization and on day 1 of each cycle. The FKSI-DRS and the EORTC QLQ-C30 Physical Functioning and Global Quality of Life scores were the primary endpoints examined. Longitudinal models were used to compare treatment arms. Sensitivity analyses were conducted to explore the impact of missing data assumptions. Results. Longitudinal trends for FKSI-DRS scores did not differ by treatment arm. Taking nonignorable missing data into account, there were significant differences between treatment arms in the trend over time for physical functioning and global quality of life, with the everolimus arm exhibiting greater decreases. All three of these measures of health-related quality of life were significantly related to progression-free survival. Conclusions. There was no evidence of a difference between everolimus and placebo in longitudinal patterns of disease-related symptoms, and little difference between the arms in physical functioning or global quality of life trends. This supports the conclusion that delay in tumor progression demonstrated by everolimus is associated with minimal impact on symptoms, physical functioning, or quality of life, as reported by patients. PMID:21459902

Investigation of associations of ARMS2, CD14, and TLR4 gene polymorphisms with wet age-related macular degeneration in a Greek population

PubMed Central

Sarli, Antonia; Skalidakis, Iosif; Velissari, Aliki; Koutsandrea, Chryssanthi; Stefaniotou, Maria; Petersen, Michael B; Kroupis, Christos; Kitsos, George; Moschos, Marilita M

2017-01-01

Background Age-related macular degeneration (AMD) is a multifactorial degenerative ocular disease that leads to loss of central vision. Functional gene polymorphisms have already been associated with the disease (for example, ARMS2 A69S, rs10490924). Aim The goal of our study was to verify the correlation of the aforementioned ARMS2 variation with the disease, to examine, for the first time, the role of the CD14 C260T variation (rs2569190), and to investigate the association of two TLR4 polymorphisms (Asp299Gly or rs4986790 and Thr399Ile or rs4986791) in a Greek population with the wet form of AMD. Patients and methods Genomic DNAs were isolated from blood samples of 103 healthy controls and 120 Greek patients with wet AMD who were age- and sex-matched, and all of whom were clinically evaluated. For the genotyping of all selected polymorphisms, polymerase chain reaction–restriction fragment length polymorphism analysis was performed. Results and conclusions This study confirmed the association between the ARMS2 variation and AMD, detecting the T risk allele in a significantly higher frequency in the patient group, compared with the control subjects (45% vs 29.13%, P<0.001, odds ratio [OR] 1.99, confidence interval 1.34–2.95). For the CD14 polymorphism, no statistically significant correlation was observed. As for the TLR4 polymorphisms, the percentage of heterozygotes increased from 2.9% to 11.7% in the patient population for Asp299Gly and from 1.9% to 10% for the Thr399Ile polymorphism (ORs 4.40 [P=0.01] and 5.61 [P=0.0088], respectively). Although our ARMS2 and CD14 results provided definite conclusions, the role of innate immunity TLR4 gene awaits further investigation in larger AMD populations with more clinical data collected on past microbial infections. PMID:28794612

A systematic review of the etiopathogenesis of Kienböck's disease and a critical appraisal of its recognition as an occupational disease related to hand-arm vibration

PubMed Central

2012-01-01

Background We systematically reviewed etiological factors of Kienböck’s disease (osteonecrosis of the lunate) discussed in the literature in order to examine the justification for including Kienböck’s disease (KD) in the European Listing of Occupational Diseases. Methods We searched the Ovid/Medline and the Cochrane Library for articles discussing the etiology of osteonecrosis of the lunate published since the first description of KD in 1910 and up until July 2012 in English, French or German. Literature was classified by the level of evidence presented, the etiopathological hypothesis discussed, and the author's conclusion about the role of the etiopathological hypothesis. The causal relationship between KD and hand-arm vibration was elucidated by the Bradford Hill criteria. Results A total of 220 references was found. Of the included 152 articles, 140 (92%) reached the evidence level IV (case series). The four most frequently discussed factors were negative ulnar variance (n=72; 47%), primary arterial ischemia of the lunate (n=63; 41%), trauma (n=63; 41%) and hand-arm vibration (n=53; 35%). The quality of the cohort studies on hand-arm vibration did not permit a meta-analysis to evaluate the strength of an association to KD. Evidence for the lack of consistency, plausibility and coherence of the 4 most frequently discussed etiopathologies was found. No evidence was found to support any of the nine Bradford Hill criteria for a causal relationship between KD and hand-arm vibration. Conclusions A systematic review of 220 articles on the etiopathology of KD and the application of the Bradford Hill criteria does not provide sufficient scientific evidence to confirm or refute a causal relationship between KD and hand-arm vibration. This currently suggests that, KD does not comply with the criteria of the International Labour Organization determining occupational diseases. However, research with a higher level of evidence is required to further determine if hand-arm vibration is a risk factor for KD. PMID:23171057

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

Eich, Hans Theodor; Gossmann, Axel; Engert, Andreas

Purpose: The role of radiotherapy (RT) after intensive chemotherapy in patients with advanced stage Hodgkin's lymphoma (HL) is still unclear. The German Hodgkin Study Group (GHSG) randomized HD12 trial was designed to test whether consolidative RT in the region of initial bulky disease and of residual disease is necessary after effective chemotherapy. A quality control program based on a multidisciplinary panel of radiation oncologists, radiologists, and medical oncologists who reviewed all patients' staging and restaging imaging was initiated. Methods and Materials: A total of 1661 patients aged 16 to 65 years with HL in Stage IIB (large mediastinal mass and/ormore » E-lesions) or Stage III to IV were randomized from January 1999 to January 2003 according to a factorial design between: 8 esc.BEACOPP + RT (arm A), 8 esc.BEACOPP non-RT (arm B), 4+4BEACOPP + RT (arm C), 4+4BEACOPP non-RT (arm D). Results: In the fifth interim analysis, 1449 patients were eligible for the arm comparison with regard to RT. After a median observation time of 48 months the FFTF rate was 86% and the OS 92%. The FFTF was 95% in the RT arms A+C and 88% in the non-RT arms B+D: no sequential significant difference. One thousand and eighty four patients were evaluated by the panel. The panel defined initial bulky disease in 800 patients and residual disease in 600 patients. The panel recommended continuation of therapy according to the randomization for 934 of 1084 patients and additive RT independently from the randomization arm for 145 of 1084 patients. Conclusions: The study showed that RT can be reduced substantially after effective chemotherapy. However, because of the irradiation of 10% of patients in the non-RT arms, equivalent effectiveness of a non-RT strategy cannot be proved. A substantial limitation of consolidative RT according to expert panel recommendations appears to be possible without reducing effectiveness.« less

Neoadjuvant Chemoradiation for Distal Rectal Cancer: 5-Year Updated Results of a Randomized Phase 2 Study of Neoadjuvant Combined Modality Chemoradiation for Distal Rectal Cancer

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

Mohiuddin, Mohammed, E-mail: asemuddin@gmail.com; Paulus, Rebecca; Mitchell, Edith

2013-07-01

Purpose: To assess the efficacy of 2 different approaches to neoadjuvant chemoradiation for distal rectal cancers. Methods and Materials: One hundred six patients with T3/T4 distal rectal cancers were randomized in a phase 2 study. Patients received either continuous venous infusion (CVI) of 5-Fluorouracil (5-FU), 225 mg/m{sup 2} per day, 7 days per week plus pelvic hyperfractionated radiation (HRT), 45.6 Gy at 1.2 Gy twice daily plus a boost of 9.6 to 14.4 Gy for T3 or T4 cancers (Arm 1), or CVI of 5-FU, 225 mg/m{sup 2} per day, Monday to Friday, plus irinotecan, 50 mg/m{sup 2} once weeklymore » × 4, plus pelvic radiation therapy (RT), 45 Gy at 1.8 Gy per day and a boost of 5.4 Gy for T3 and 9 Gy for T4 cancers (Arm 2). Surgery was performed 4 to 10 weeks later. Results: All eligible patients (n=103) are included in this analysis; 2 ineligible patients were excluded, and 1 patient withdrew consent. Ninety-eight of 103 patients (95%) underwent resection. Four patients did not undergo surgery for either disease progression or patient refusal, and 1 patient died during induction chemotherapy. The median time of follow-up was 6.4 years in Arm 1 and 7.0 years in Arm 2. The pathological complete response (pCR) rates were 30% in Arm 1 and 26% in Arm 2. Locoregional recurrence rates were 16% in Arm 1 and 17% in Arm 2. Five-year survival rates were 61% and 75% and Disease-specific survival rates were 78% and 85% for Arm1 and Arm 2, respectively. Five second primaries occurred in patients on Arm 1, and 1 second primary occurred in Arm 2. Conclusions: High rates of disease-specific survival were seen in each arm. Overall survival appears affected by the development of unrelated second cancers. The high pCR rates with 5-FU and higher dose radiation in T4 cancers provide opportunity for increased R0 resections and improved survival.« less

Wrist muscle activity of khatrah approach in Mameluke technique using traditional bow archery

NASA Astrophysics Data System (ADS)

Ariffin, Muhammad Shahimi; Rambely, Azmin Sham; Ariff, Noratiqah Mohd

2018-04-01

An investigation of khatrah technique in archery was carried out. An electromyography (EMG) experiment was conducted towards six wrist muscles which are flexor carpi radialis, extensor carpi ulnaris and extensor digitorum communis for both arms. The maximum voluntary contraction (MVC) and activity data were recorded. The bow arm produced a higher muscle force compared to draw arm muscles during release phase. However, the muscle forces produced by bow arm had a consistency in term of pattern throughout the phases. In conclusion, the forces generated by the professional archer produced a force benchmark at the wrist joint to alleviate the risk of injury.

Evidence-based Narratives to Improve Recall of Opioid Prescribing Guidelines: A Randomized Experiment

PubMed Central

Kilaru, Austin S.; Perrone, Jeanmarie; Auriemma, Catherine L.; Shofer, Frances S.; Barg, Frances K.; Meisel, Zachary F.

2014-01-01

Objectives Physicians adopt evidence-based guidelines with variable consistency. Narratives, or stories, offer a novel dissemination strategy for clinical recommendations. The study objective was to compare whether evidence-based narrative versus traditional summary improved recall of opioid prescribing guidelines from the American College of Emergency Physicians (ACEP). Methods This was a prospective, randomized controlled experiment to compare whether narrative versus summary promoted short-term recall of six themes contained in the ACEP opioid guideline. The experiment was modeled after the free-recall test, an established technique in studies of memory. At a regional conference, emergency physicians were randomized to read either a summary of the guideline (control) or a narrative (intervention). The fictional narrative was constructed to match the summary in content and length. One hour after reading the text, participants listed all content that they could recall. Two reviewers independently scored the responses to assess recall of the six themes. The primary outcome was the total number of themes recalled per participant. Secondary outcomes included the proportion of responses in each study arm that recalled individual themes and the proportion of responses in each arm that contained falsely recalled or extraneous information. Results Ninety-five physicians were randomized. Eighty-two physicians completed the experiment, for a response rate of 86%. The mean of the total number of themes recalled per participant was 3.1 in the narrative arm versus 2.0 in the summary arm (difference = 1.1, 95% confidence interval [CI] = 0.6 to 1.7). For three themes, the proportion of responses that recalled the theme was significantly greater in the narrative arm compared to the summary arm, with the differences ranging from 20% to 51%. For one theme, recall was significantly greater in the summary arm. For two themes, there was no statistically significant difference in recall between the arms. In the summary arm, 54% of responses were found to contain falsely recalled or extraneous information versus 21% of responses in the narrative arm (difference = 33%, 95% CI = 14% to 53%). Conclusions Physicians exposed to a narrative about opioid guidelines were more likely to recall guideline content at 1 hour than those exposed to a summary of the guidelines. Future studies should examine whether the incorporation of narratives in dissemination campaigns improves guideline adoption and changes clinical practice. PMID:24761456

[Frequency and variables associated with perceived devaluation-discrimination in victims of the armed conflict in Colombia].

PubMed

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

2017-11-21

There is no information on frequency of perceived devaluation-discrimination in victims of the armed conflict in Colombia. The aim of this study was thus to determine the frequency of perceived devaluation-discrimination and associated variables among victims of the armed conflict in municipalities in the Department of Magdalena, Colombia. A cross-sectional study was conducted among victims enrolled in the Program for Psychosocial Care and Comprehensive Healthcare for Victims. Depressive symptoms were quantified with four dichotomous items (three or more were classified as high level of depressive symptoms), and perceived devaluation-discrimination was quantified with six dichotomous items (two or more were classified as high perceived devaluation-discrimination). A total of 943 adults participated (M = 47.9; SD = 14.2); 67.4%, women; 109 (11.6%) reported high level of depressive symptoms and 217 (23%) showed high perceived devaluation-discrimination. High perceived devaluation-discrimination was associated with high level of depressive symptoms (OR = 6.47; 95%CI: 4.23-9.88). In conclusion, one-fourth of the victims of the armed conflict in Magdalena reported high perceived devaluation-discrimination, which was significantly associated with high level of depressive symptoms.

“This is a kind of betrayal”: a qualitative study of disability after breast cancer

PubMed Central

Thomas–MacLean, R.; Towers, A.; Quinlan, E.; Hack, T.F.; Kwan, W.; Miedema, B.; Tilley, A.; Graham, P.

2009-01-01

Objective We proposed to document the effect of arm morbidity and disability in 40 Canadian women who were 12–24 months post breast cancer surgery. Methods We completed 40 qualitative interviews as one component of a multidisciplinary national longitudinal study of arm morbidity after breast cancer (n = 745) involving four research sites (Fredericton/Saint John, Montreal, Winnipeg, Surrey). During semi-structured interviews, participants who had reported arm morbidity and disability in earlier surveys were asked to discuss the effects of these conditions on everyday life. Results The interviewees reported making major adjustments to paid and unpaid work, which often involved the assistance of family members, thus demonstrating the effect of disability. Interview data resulted in the creation of a model that addresses arm morbidity and disability, and that holds implications for health care professionals. Conclusions Based on the interview findings, we conclude that a robust measure of disability after breast cancer should be developed. In the absence of a validated measure of the effect of disability, evaluating qualitative responses to questions about everyday activities could provide the impetus for provision of physical therapy and emotional support. PMID:19526082

The metabolic cost of human running: is swinging the arms worth it?

PubMed

Arellano, Christopher J; Kram, Rodger

2014-07-15

Although the mechanical function is quite clear, there is no consensus regarding the metabolic benefit of arm swing during human running. We compared the metabolic cost of running using normal arm swing with the metabolic cost of running while restricting the arms in three different ways: (1) holding the hands with the arms behind the back in a relaxed position (BACK), (2) holding the arms across the chest (CHEST) and (3) holding the hands on top of the head (HEAD). We hypothesized that running without arm swing would demand a greater metabolic cost than running with arm swing. Indeed, when compared with running using normal arm swing, we found that net metabolic power demand was 3, 9 and 13% greater for the BACK, CHEST and HEAD conditions, respectively (all P<0.05). We also found that when running without arm swing, subjects significantly increased the peak-to-peak amplitudes of both shoulder and pelvis rotation about the vertical axis, most likely a compensatory strategy to counterbalance the rotational angular momentum of the swinging legs. In conclusion, our findings support our general hypothesis that swinging the arms reduces the metabolic cost of human running. Our findings also demonstrate that arm swing minimizes torso rotation. We infer that actively swinging the arms provides both metabolic and biomechanical benefits during human running. © 2014. Published by The Company of Biologists Ltd.

Secreted frizzled related protein 3 (SFRP3) is required for tumorigenesis of PAX3-FOXO1-positive alveolar rhabdomyosarcoma

PubMed Central

Kephart, Julie J.G.; Tiller, Rosanne G.J.; Crose, Lisa E.S.; Slemmons, Katherine K.; Chen, Po-Han; Hinson, Ashley R.; Bentley, Rex C.; Chi, Jen-Tsan Ashley; Linardic, Corinne M.

2015-01-01

Purpose Rhabdomyosarcoma is a soft tissue sarcoma associated with the skeletal muscle lineage. Of the two predominant subtypes, known as embryonal (eRMS) and alveolar (aRMS), aRMS has the poorer prognosis, with a 5-year survival rate of <50%. The majority of aRMS tumors express the fusion protein PAX3-FOXO1. As PAX3-FOXO1 has proven chemically intractable, the current study aims to identify targetable proteins that are downstream from or cooperate with PAX3-FOXO1 to support tumorigenesis. Experimental Design Microarray analysis of the transcriptomes of human skeletal muscle myoblasts expressing PAX3-FOXO1 revealed alteration of several Wnt pathway gene members, including secreted frizzled related protein 3 (SFRP3), a secreted Wnt pathway inhibitor. Loss-of-function using shRNAs against SFRP3 were used to interrogate the role of SFRP3 in human aRMS cell lines in vitro and conditional murine xenograft systems in vivo. The combination of SFRP3 genetic suppression and the chemotherapeutic agent vincristine was also examined. Results In vitro, suppression of SFRP3 inhibited aRMS cell growth, reduced proliferation accompanied by a G1 arrest and induction of p21, and induced apoptosis. In vivo, doxycycline-inducible suppression of SFRP3 reduced aRMS tumor growth and weight by more than three-fold, in addition to increasing myogenic differentiation and β-catenin signaling. The combination of SFRP3 suppression and vincristine was more effective at reducing aRMS cell growth in vitro than either treatment alone, and ablated tumorigenesis in vivo. Conclusions SFRP3 is necessary for the growth of human aRMS cells both in vitro and in vivo and is a promising new target for investigation in aRMS. PMID:26071485

Circulating Tumor Cells and Response to Chemotherapy in Metastatic Breast Cancer: SWOG S0500

PubMed Central

Smerage, Jeffrey B.; Barlow, William E.; Hortobagyi, Gabriel N.; Winer, Eric P.; Leyland-Jones, Brian; Srkalovic, Gordan; Tejwani, Sheela; Schott, Anne F.; O'Rourke, Mark A.; Lew, Danika L.; Doyle, Gerald V.; Gralow, Julie R.; Livingston, Robert B.; Hayes, Daniel F.

2014-01-01

Purpose Increased circulating tumor cells (CTCs; five or more CTCs per 7.5 mL of whole blood) are associated with poor prognosis in metastatic breast cancer (MBC). A randomized trial of patients with persistent increase in CTCs tested whether changing chemotherapy after one cycle of first-line chemotherapy would improve the primary outcome of overall survival (OS). Patients and Methods Patients with MBC who did not have increased CTCs at baseline remained on initial therapy until progression (arm A). Patients with initially increased CTCs that decreased after 21 days of therapy remained on initial therapy (arm B). Patients with persistently increased CTCs after 21 days of therapy were randomly assigned to continue initial therapy (arm C1) or change to an alternative chemotherapy (arm C2). Results Of 595 eligible and evaluable patients, 276 (46%) did not have increased CTCs (arm A). Of those with initially increased CTCs, 31 (10%) were not retested, 165 were assigned to arm B, and 123 were randomly assigned to arm C1 or C2. No difference in median OS was observed between arm C1 and C2 (10.7 and 12.5 months, respectively; P = .98). CTCs were strongly prognostic. Median OS for arms A, B, and C (C1 and C2 combined) were 35 months, 23 months, and 13 months, respectively (P < .001). Conclusion This study confirms the prognostic significance of CTCs in patients with MBC receiving first-line chemotherapy. For patients with persistently increased CTCs after 21 days of first-line chemotherapy, early switching to an alternate cytotoxic therapy was not effective in prolonging OS. For this population, there is a need for more effective treatment than standard chemotherapy. PMID:24888818

Enabling image fusion for a CT guided needle placement robot

NASA Astrophysics Data System (ADS)

Seifabadi, Reza; Xu, Sheng; Aalamifar, Fereshteh; Velusamy, Gnanasekar; Puhazhendi, Kaliyappan; Wood, Bradford J.

2017-03-01

Purpose: This study presents development and integration of hardware and software that enables ultrasound (US) and computer tomography (CT) fusion for a FDA-approved CT-guided needle placement robot. Having real-time US image registered to a priori-taken intraoperative CT image provides more anatomic information during needle insertion, in order to target hard-to-see lesions or avoid critical structures invisible to CT, track target motion, and to better monitor ablation treatment zone in relation to the tumor location. Method: A passive encoded mechanical arm is developed for the robot in order to hold and track an abdominal US transducer. This 4 degrees of freedom (DOF) arm is designed to attach to the robot end-effector. The arm is locked by default and is released by a press of button. The arm is designed such that the needle is always in plane with US image. The articulated arm is calibrated to improve its accuracy. Custom designed software (OncoNav, NIH) was developed to fuse real-time US image to a priori-taken CT. Results: The accuracy of the end effector before and after passive arm calibration was 7.07mm +/- 4.14mm and 1.74mm +/-1.60mm, respectively. The accuracy of the US image to the arm calibration was 5mm. The feasibility of US-CT fusion using the proposed hardware and software was demonstrated in an abdominal commercial phantom. Conclusions: Calibration significantly improved the accuracy of the arm in US image tracking. Fusion of US to CT using the proposed hardware and software was feasible.

Arms production in Japan: The military applications of civilian technology

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

Drifte, R.

1986-01-01

The author examines both the domestic and international environments encouraging Japan's leaders not only to strengthen the country's defense, but to do so more independently. Until recently, the arms industry has been nurtured by U.S. weapons technology, but growing dependence on electronics dramatically increases Japan's contribution to modern weapons systems. The electronics revolution is creating more and more dual-purpose products, undermining the Japanese cabinet policy of prohibiting arms export. The discovery of wider applications for Japanese manufacturers' most advanced civilian technology is a strong motivation for entering the arms arena. The book illustrates that Japan's entry into the field ismore » a dynamic example of the success of Japanese industry as it enters new technological areas. The author discusses: Development and the Present Situation of Japan's Arms Production Capability; Research and Development; The Shipbuilding Industry; The Aircraft Industry; The Space and Missile Industry; and Arms Exports with conclusions.« less

A low arm and leg muscle mass to total body weight ratio is associated with an increased prevalence of metabolic syndrome: The Korea National Health and Nutrition Examination Survey 2010-2011.

PubMed

Kim, Yong Hwan; So, Wi-Young

2016-09-14

The aim of this study was to investigate the association between metabolic syndrome (MetS) and arm and leg muscle mass to total weight ratios in Korean adults. This was a randomized, controlled, cross-sectional study. Data from 2,383 adults (1,030 men and 1,353 women) were collected from the Korea National Health and Nutrition Examination Survey 2010-2011. Blood lipid profiles, blood pressure, and anthropometric characteristics, including weight, height, waist circumference, and muscle mass on dual energy X-ray absorptiometry (DXA), were evaluated in the participants. MetS was defined according to the criteria of the National Cholesterol Education Program Adult Treatment Panel III. The average mass of both arms and legs was determined using regional muscle analysis by DXA. Afterwards, the arm and leg muscle mass to total body weight ratio was determined and classified into 4 quartiles (i.e., quartile 1 [highest muscle ratio] to quartile 4 [lowest muscle ratio]). According to the arm muscle and leg muscle ratios, there was a higher prevalence of MetS in quartile 4 than in quartile 1 in both men and women. A low arm and leg muscle mass to body weight ratio was associated with a higher prevalence of MetS after adjusting for age, physical activity, frequency of smoking, and frequency of alcohol consumption. In conclusion, MetS patients demonstrated a lower arm and leg muscle mass to body weight ratio. Strength training for the lower and upper extremities is recommended because it can have a positive effect on MetS prevention.

Safety and efficacy of lactoferrin versus ferrous sulphate in curing iron deficiency and iron deficiency anaemia in hereditary thrombophilia pregnant women: an interventional study.

PubMed

Paesano, Rosalba; Pacifici, Enrica; Benedetti, Samanta; Berlutti, Francesca; Frioni, Alessandra; Polimeni, Antonella; Valenti, Piera

2014-10-01

Objective Evaluate the safety and efficacy of bovine lactoferrin (bLf) versus the ferrous sulphate standard intervention in curing iron deficiency (ID) and ID anaemia (IDA) in pregnant women affected by hereditary thrombophilia (HT). Design Interventional study. Setting Secondary-level hospital for complicated pregnancies in Rome, Italy. Population 295 HT pregnant women (≥18 years) suffering from ID/IDA. Methods Women were enrolled in Arm A or B in accordance with their personal choice. In Arm A, 156 women received oral administration of 100 mg of bLf twice a day; in Arm B, 139 women received 520 mg of ferrous sulphate once a day. Therapies lasted until delivery. Main outcome measures Red blood cells, haemoglobin, total serum iron, serum ferritin (haematological parameters) were assayed before and every 30 days during therapy until delivery. Serum IL-6, key factor in inflammatory and iron homeostasis disorders, was detected at enrolment and after therapy at delivery. Possible maternal, foetal, and neonatal adverse effects were assessed. Results Haematological parameters were significantly higher in Arm A than in Arm B pregnant women (P ≤ 0.0001). Serum IL-6 significantly decreased in bLf-treated women and increased in ferrous sulphate-treated women. BLf did not exert any adverse effect. Adverse effects in 16.5 % of ferrous sulphate-treated women were recorded. Arm A women experienced no miscarriage compared to five miscarriages in Arm B women. Conclusions Differently from ferrous sulphate, bLf is safe and effective in curing ID/IDA associated with a consistent decrease of serum IL-6. The absence of miscarriage among bLf-treated women provided an unexpected benefit. ClinicalTrials.gov Identifier NCT01221844.

An mHealth Model to Increase Clinic Attendance for Breast Symptoms in Rural Bangladesh: Can Bridging the Digital Divide Help Close the Cancer Divide?

PubMed Central

Chowdhury, Mridul; Wu, Wei; Chowdhury, Md Touhidul Imran; Pal, Bidhan Chandra; Hasan, Rifat; Khan, Zahid H.; Dutta, Dali; Saeem, Arif Abu; Al-Mansur, Raiyan; Mahmud, Sahin; Woods, James H.; Story, Heather H.; Salim, Reza

2014-01-01

Objective. To demonstrate proof of concept for a smart phone-empowered community health worker (CHW) model of care for breast health promotion, clinical breast examination (CBE), and patient navigation in rural Bangladesh. Methods. This study was a randomized controlled trial; July 1 to October 31, 2012, 30 CHWs conducted door-to-door interviews of women aged 25 and older in Khulna Division. Only women who disclosed a breast symptom were offered CBE. Arm A: smart phone with applications to guide interview, report data, show motivational video, and offer appointment for women with an abnormal CBE. Arm B: smart phone/applications identical to Arm A plus CHW had training in “patient navigation” to address potential barriers to seeking care. Arm C: control arm (no smart phone; same interview recorded on paper). Outcomes are presented as the “adherence” (to advice regarding a clinic appointment) for women with an abnormal CBE. This study was approved by Women’s College Hospital Research Ethics Board (Toronto, Ontario, Canada) and district government officials (Khulna, Bangladesh). Funded by Grand Challenges Canada. Results. In 4 months, 22,337 women were interviewed; <1% declined participation, and 556 women had an abnormal CBE. Control group CHWs completed fewer interviews, had inferior data quality, and identified significantly fewer women with abnormal breast exams compared with CHWs in arms A and B. Arm B had the highest adherence. Conclusion. CHWs guided by our smart phone applications were more efficient and effective in breast health promotion compared with the control group. CHW “navigators” were most effective in encouraging women with an abnormal breast examination to adhere to advice regarding clinic attendance. PMID:24396050

Contrast-Enhanced C-arm Computed Tomography Imaging of Myocardial Infarction in the Interventional Suite

PubMed Central

Girard, Erin E; Al-Ahmad, Amin; Rosenberg, Jarrett; Luong, Richard; Moore, Teri; Lauritsch, Günter; Chan, Frandics; Lee, David P.; Fahrig, Rebecca

2014-01-01

Objectives Cardiac C-arm CT uses a standard C-arm fluoroscopy system rotating around the patient to provide CT-like images during interventional procedures without moving the patient to a conventional CT scanner. We hypothesize that C-arm computed tomography (CT) can be used to visualize and quantify the size of perfusion defects and late enhancement resulting from a myocardial infarction (MI) using contrast enhanced techniques similar to previous CT and magnetic resonance imaging studies. Materials and Methods A balloon occlusion followed by reperfusion in a coronary artery was used to study acute and subacute MI in 12 swine. ECG-gated C-arm CT images were acquired the day of infarct creation (n=6) or 4 weeks after infarct creation (n = 6). Images were acquired immediately following contrast injection, then at 1 minute, and every 5 minutes up to 30 minutes with no additional contrast. The volume of the infarct as measured on C-arm CT was compared against pathology. Results The volume of acute MI, visualized as a combined region of hyperenhancement with a hypoenhanced core, correlated well with pathologic staining (concordance correlation = 0.89, p<0.0001, mean difference = 0.67±2.98 cm3). The volume of subacute MI, visualized as a region of hyperenhancement, correlated well with pathologic staining at imaging times 5–15 minutes following contrast injection (concordance correlation = 0.82, p<.001, mean difference = −0.64±1.94 cm3). Conclusions C-arm CT visualization of acute and subacute myocardial infarction is possible in a porcine model but improvement in the imaging technique is important before clinical use. Visualization of MI in the catheterization lab may be possible and could provide 3D images for guidance during interventional procedures. PMID:25635589

How good are GPs at adhering to a pragmatic trial protocol in primary care? Results from the ADDITION-Cambridge cluster-randomised pragmatic trial

PubMed Central

Boothby, Clare E; Griffin, Simon J

2018-01-01

Objective To assess the fidelity of general practitioners’ (GPs) adherence to a long-term pragmatic trial protocol. Design Retrospective analyses of electronic primary care records of participants in the pragmatic cluster-randomised ADDITION (Anglo-Danish-Dutch Study of Intensive Treatment In People with Screen Detected Diabetes in Primary Care)-Cambridge trial, comparing intensive multifactorial treatment (IT) versus routine care (RC). Data were collected from the date of diagnosis until December 2010. Setting Primary care surgeries in the East of England. Study sample/participants A subsample (n=189, RC arm: n=99, IT arm: n=90) of patients from the ADDITION-Cambridge cohort (867 patients), consisting of patients 40–69 years old with screen-detected diabetes mellitus. Interventions In the RC arm treatment was delivered according to concurrent treatment guidelines. Surgeries in the IT arm received funding for additional contacts between GPs/nurses and patients, and GPs were advised to follow more intensive treatment algorithms for the management of glucose, lipids and blood pressure and aspirin therapy than in the RC arm. Outcome measures The number of annual contacts between patients and GPs/nurses, the proportion of patients receiving prescriptions for cardiometabolic medication in years 1–5 after diabetes diagnosis and the adherence to prescription algorithms. Results The difference in the number of annual GP contacts (β=0.65) and nurse contacts (β=−0.15) between the study arms was small and insignificant. Patients in the IT arm were more likely to receive glucose-lowering (OR=3.27), ACE-inhibiting (OR=2.03) and lipid-lowering drugs (OR=2.42, all p values <0.01) than patients in the RC arm. The prescription adherence varied between medication classes, but improved in both trial arms over the 5-year follow-up. Conclusions The adherence of GPs to different aspects of the trial protocol was mixed. Background changes in healthcare policy need to be considered as they have the potential to dilute differences in treatment intensity and hence incremental effects. Trial registration number ISRCTN86769081. PMID:29903781

Vascular Accesses for Haemodialysis in the Upper Arm Cause Greater Reduction in the Carotid-Brachial Stiffness than Those in the Forearm: Study of Gender Differences

PubMed Central

Bia, Daniel; Cabrera-Fischer, Edmundo I.; Zócalo, Yanina; Galli, Cintia; Graf, Sebastián; Valtuille, Rodolfo; Pérez-Cámpos, Héctor; Saldías, María; Álvarez, Inés; Armentano, Ricardo L.

2012-01-01

Purpose. To evaluate in chronically haemodialysed patients (CHPs), if: (1) the vascular access (VA) position (upper arm or forearm) is associated with differential changes in upper limb arterial stiffness; (2) differences in arterial stiffness exist between genders associated with the VA; (3) the vascular substitute (VS) of choice, in biomechanical terms, depends on the previous VA location and CHP gender. Methods. 38 CHPs (18 males; VA in upper arm: 18) were studied. Left and right carotid-brachial pulse wave velocity (PWVc-b) was measured. In in vitro studies, PWV was obtained in ePTFE prostheses and in several arterial and venous homografts obtained from donors. The biomechanical mismatch (BM) between CHP native vessel (NV) and VS was calculated. Results/Conclusions. PWVc-b in upper limbs with VA was lower than in the intact contralateral limbs (P < 0.05), and differences were higher (P < 0.05) when the VA was performed in the upper arm. Differences between PWVc-b in upper limbs with VA (in the upper arm) with respect to intact upper limbs were higher (P < 0.05) in males. Independently of the region in which the VA was performed, the homograft that ensured the minimal BM was the brachial artery. The BM was highly dependent on gender and the location in the upper limb in which the VA was performed. PMID:22567282

Do stigma and other perceived barriers to mental health care differ across Armed Forces?

PubMed Central

Gould, Matthew; Adler, Amy; Zamorski, Mark; Castro, Carl; Hanily, Natalie; Steele, Nicole; Kearney, Steve; Greenberg, Neil

2010-01-01

Summary Objectives Military organizations are keen to address barriers to mental health care yet stigma and barriers to care remain little understood, especially potential cultural differences between Armed Forces. The aim of this study was to compare data collected by the US, UK, Australian, New Zealand and Canadian militaries using Hoge et al.'s perceived stigma and barriers to care measure (Combat duty in Iraq and Afghanistan, mental health problems and barriers to care. New Engl J Med 2004;351:13–22). Design Each member country identified data sources that had enquired about Hoge et al.'s perceived stigma and perceived barriers to care items in the re-deployment or immediate post-deployment period. Five relevant statements were included in the study. Setting US, UK Australian, New Zealand and Canadian Armed Forces. Results Concerns about stigma and barriers to care tended to be more prominent among personnel who met criteria for a mental health problem. The pattern of reported stigma and barriers to care was similar across the Armed Forces of all five nations. Conclusions Barriers to care continue to be a major issue for service personnel within Western military forces. Although there are policy, procedural and cultural differences between Armed Forces, the nations studied appear to share some similarities in terms of perceived stigma and barriers to psychological care. Further research to understand patterns of reporting and subgroup differences is required. PMID:20382906

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

The effects of spinal mobilization with arm movements on shoulder muscle strengthening

PubMed Central

Seo, Youngjoon; Lee, Jaeseok; Han, Dongwook

2015-01-01

[Purpose] This study was performed to examine the immediate effects of spinal mobilization with arm movements (SMWAMs) for strengthening the shoulder muscles. [Subjects] The subjects of this study were 12 healthy male students who were studying at S University, Busan City. They had no musculoskeletal disease, or upper congenital malformation, and had no history of surgery or neurological disease. [Methods] The SMWAMs were performed on the 4th cervical vertebra (C4). For stimulation of the 5th cervical nerve, the spinous process of the C4 was pushed to the left and held in place. Then the arm was abducted to the point where spinous process was felt, and the range of abduction was examined. Subsequently, the abduction movement was repeated 10 times to the same point, and the gliding of C4 was held until the arm returned to the starting position. During the treatment, the head and the trunk were held in the correct posture. [Results] After SMWAMs had been performed, the muscular strength of shoulder flexion, extension and adduction significantly increased. [Conclusion] In our opinion, the SMWAMs are a very useful method for correcting spinal malalignment, and for stimulating the joint mechanoreceptors without the risks of manipulation. SMWAM is a valuable therapy method that can complement the demerits of mobilization. PMID:25642026

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.

The Resonating Arm Exerciser: design and pilot testing of a mechanically passive rehabilitation device that mimics robotic active assistance

PubMed Central

2013-01-01

Background Robotic arm therapy devices that incorporate actuated assistance can enhance arm recovery, motivate patients to practice, and allow therapists to deliver semi-autonomous training. However, because such devices are often complex and actively apply forces, they have not achieved widespread use in rehabilitation clinics or at home. This paper describes the design and pilot testing of a simple, mechanically passive device that provides robot-like assistance for active arm training using the principle of mechanical resonance. Methods The Resonating Arm Exerciser (RAE) consists of a lever that attaches to the push rim of a wheelchair, a forearm support, and an elastic band that stores energy. Patients push and pull on the lever to roll the wheelchair back and forth by about 20 cm around a neutral position. We performed two separate pilot studies of the device. In the first, we tested whether the predicted resonant properties of RAE amplified a user’s arm mobility by comparing his or her active range of motion (AROM) in the device achieved during a single, sustained push and pull to the AROM achieved during rocking. In a second pilot study designed to test the therapeutic potential of the device, eight participants with chronic stroke (35 ± 24 months since injury) and a mean, stable, initial upper extremity Fugl-Meyer (FM) score of 17 ± 8 / 66 exercised with RAE for eight 45 minute sessions over three weeks. The primary outcome measure was the average AROM measured with a tilt sensor during a one minute test, and the secondary outcome measures were the FM score and the visual analog scale for arm pain. Results In the first pilot study, we found people with a severe motor impairment after stroke intuitively found the resonant frequency of the chair, and the mechanical resonance of RAE amplified their arm AROM by a factor of about 2. In the second pilot study, AROM increased by 66% ± 20% (p = 0.003). The mean FM score increase was 8.5 ± 4 pts (p = 0.009). Subjects did not report discomfort or an increase in arm pain with rocking. Improvements were sustained at three months. Conclusions These results demonstrate that a simple mechanical device that snaps onto a manual wheelchair can use resonance to assist arm training, and that such training shows potential for safely increasing arm movement ability for people with severe chronic hemiparetic stroke. PMID:23597303

Rural providers' access to online resources: a randomized controlled trial

PubMed Central

Hall, Laura J.; McElfresh, Karen R.; Warner, Teddy D.; Stromberg, Tiffany L.; Trost, Jaren; Jelinek, Devin A.

2016-01-01

Objective The research determined the usage and satisfaction levels with one of two point-of-care (PoC) resources among health care providers in a rural state. Methods In this randomized controlled trial, twenty-eight health care providers in rural areas were stratified by occupation and region, then randomized into either the DynaMed or the AccessMedicine study arm. Study participants were physicians, physician assistants, and nurses. A pre- and post-study survey measured participants' attitudes toward different information resources and their information-seeking activities. Medical student investigators provided training and technical support for participants. Data analyses consisted of analysis of variance (ANOVA), paired t tests, and Cohen's d statistic to compare pre- and post-study effects sizes. Results Participants in both the DynaMed and the AccessMedicine arms of the study reported increased satisfaction with their respective PoC resource, as expected. Participants in both arms also reported that they saved time in finding needed information. At baseline, both arms reported too little information available, which increased to “about right amounts of information” at the completion of the study. DynaMed users reported a Cohen's d increase of +1.50 compared to AccessMedicine users' reported use of 0.82. DynaMed users reported d2 satisfaction increases of 9.48 versus AccessMedicine satisfaction increases of 0.59 using a Cohen's d. Conclusion Participants in the DynaMed arm of the study used this clinically oriented PoC more heavily than the users of the textbook-based AccessMedicine. In terms of user satisfaction, DynaMed users reported higher levels of satisfaction than the users of AccessMedicine. PMID:26807050

Contrast-enhanced cardiac C-arm CT evaluation of radiofrequency ablation lesions in the left ventricle

PubMed Central

Girard, Erin E; Al-Ahmad, Amin A; Rosenberg, Jarrett; Luong, Richard; Moore, Teri; Lauritsch, Günter; Boese, Jan; Fahrig, Rebecca

2011-01-01

Objectives The purpose of this study was to evaluate use of cardiac C-arm computed tomography (CT) in the assessment of the dimensions and temporal characteristics of radiofrequency ablation (RFA) lesions. This imaging modality uses a standard C-arm fluoroscopy system rotating around the patient, providing CT-like images during the RFA procedure. Background Both magnetic resonance imaging (MRI) and CT can be used to assess myocardial necrotic tissue. Several studies have reported visualizing cardiac RF ablation lesions with MRI, however obtaining MR images during interventional procedures is not common practice. Direct visualization of RFA lesions using C-arm CT during the procedure may improve outcomes and circumvent complications associated with cardiac ablation procedures. Methods RFA lesions were created on the endocardial surface of the left ventricle of 9 swine using a 7-F RF ablation catheter. An ECG-gated C-arm CT imaging protocol was used to acquire projection images during iodine contrast injection and following the injection every 5 min for up to 30 min, with no additional contrast. Reconstructed images were analyzed offline. The mean and standard deviation of the signal intensity of the lesion and normal myocardium were measured in all images in each time series. Lesion dimensions and area were measured and compared in pathologic specimens and C-arm CT images. Results All ablation lesions (n=29) were visualized and lesion dimensions, as measured on C-arm CT, correlated well with postmortem tissue measurements (1D dimensions : concordance correlation = 0.87; area : concordance correlation = 0.90). Lesions were visualized as a perfusion defect on first-pass C-arm CT images with a signal intensity 95 HU lower than normal myocardium (95% confidence interval: -111 to -79 HU). Images acquired at 1 and 5 minutes exhibited an enhancing ring surrounding the perfusion defect in 24 (83%) lesions. Conclusions RFA lesion size, including transmurality, can be assessed using ECG-gated cardiac C-arm CT in the interventional suite. Visualization of RFA lesions using cardiac C-arm CT may facilitate the assessment of adequate lesion delivery and provide valuable feedback during cardiac ablation procedures. PMID:21414574

Loss of Productivity Due to Neck/Shoulder Symptoms and Hand/Arm Symptoms: Results from the PROMO-Study

PubMed Central

IJmker, Stefan; Blatter, Birgitte M.; de Korte, Elsbeth M.

2007-01-01

Introduction The objective of the present study is to describe the extent of productivity loss among computer workers with neck/shoulder symptoms and hand/arm symptoms, and to examine associations between pain intensity, various physical and psychosocial factors and productivity loss in computer workers with neck/shoulder and hand/arm symptoms. Methods A cross-sectional design was used. The study population consisted of 654 computer workers with neck/shoulder or hand/arm symptoms from five different companies. Descriptive statistics were used to describe the occurrence of self-reported productivity loss. Logistic regression analyses were used to examine the associations. Results In 26% of all the cases reporting symptoms, productivity loss was involved, the most often in cases reporting both symptoms (36%). Productivity loss involved sickness absence in 11% of the arm/hand cases, 32% of the neck/shoulder cases and 43% of the cases reporting both symptoms. The multivariate analyses showed statistically significant odds ratios for pain intensity (OR: 1.26; CI: 1.12–1.41), for high effort/no low reward (OR: 2.26; CI: 1.24–4.12), for high effort/low reward (OR: 1.95; CI: 1.09–3.50), and for low job satisfaction (OR: 3.10; CI: 1.44–6.67). Physical activity in leisure time, full-time work and overcommitment were not associated with productivity loss. Conclusion In most computer workers with neck/shoulder symptoms or hand/arm symptoms productivity loss derives from a decreased performance at work and not from sickness absence. Favorable psychosocial work characteristics might prevent productivity loss in symptomatic workers. PMID:17636455

Efficient high-throughput sequencing of a laser microdissected chromosome arm

PubMed Central

2013-01-01

Background Genomic sequence assemblies are key tools for a broad range of gene function and evolutionary studies. The diploid amphibian Xenopus tropicalis plays a pivotal role in these fields due to its combination of experimental flexibility, diploid genome, and early-branching tetrapod taxonomic position, having diverged from the amniote lineage ~360 million years ago. A genome assembly and a genetic linkage map have recently been made available. Unfortunately, large gaps in the linkage map attenuate long-range integrity of the genome assembly. Results We laser dissected the short arm of X. tropicalis chromosome 7 for next generation sequencing and computational mapping to the reference genome. This arm is of particular interest as it encodes the sex determination locus, but its genetic map contains large gaps which undermine available genome assemblies. Whole genome amplification of 15 laser-microdissected 7p arms followed by next generation sequencing yielded ~35 million reads, over four million of which uniquely mapped to the X. tropicalis genome. Our analysis placed more than 200 previously unmapped scaffolds on the analyzed chromosome arm, providing valuable low-resolution physical map information for de novo genome assembly. Conclusion We present a new approach for improving and validating genetic maps and sequence assemblies. Whole genome amplification of 15 microdissected chromosome arms provided sufficient high-quality material for localizing previously unmapped scaffolds and genes as well as recognizing mislocalized scaffolds. PMID:23714049

Community-randomised controlled trial embedded in the Anishinaabek Cervical Cancer Screening Study: human papillomavirus self-sampling versus Papanicolaou cytology

PubMed Central

Zehbe, Ingeborg; Jackson, Robert; Wood, Brianne; Weaver, Bruce; Escott, Nicholas; Severini, Alberto; Krajden, Mel; Bishop, Lisa; Morrisseau, Kyla; Ogilvie, Gina; Burchell, Ann N; Little, Julian

2016-01-01

Objectives The incidence of cervical cancer is up to 20-fold higher among First Nations women in Canada than the general population, probably due to lower participation in screening. Offering human papillomavirus (HPV) self-sampling in place of Papanicolaou (Pap) testing may eventually increase screening participation and reduce cervical cancer rates in this population. Design A community-randomised controlled screening trial. Setting First Nations communities in Northwest Ontario, Canada. Participants Women aged between 25 and 69, living in Robinson Superior Treaty First Nations. The community was the unit of randomisation. Interventions Women were asked to complete a questionnaire and have screening by HPV self-sampling (arm A) or Pap testing (arm B). Primary outcome measures The number of women who participated in cervical screening. Randomisation Community clusters were randomised to include approximately equivalent numbers of women in each arm. Results 6 communities were randomised to arm A and 5 to arm B. One community withdrew, leaving 5 communities in each group (834 eligible women). Participation was <25%. Using clustered intention-to-treat (ITT) analysis, initial and cumulative averaged uptakes in arm A were 1.4-fold (20% vs 14.3%, p=0.628) and 1.3-fold (20.6% vs 16%, p=0.694) higher compared to arm B, respectively. Corresponding per protocol (PP) analysis indicates 2.2-fold (22.9% vs 10.6%, p=0.305) and 1.6-fold (22.9% vs 14.1%, p=0.448) higher uptakes in arm A compared to arm B. Screening uptake varied between communities (range 0–62.1%). Among women who completed a questionnaire (18.3% in arm A, 21.7% in arm B), the screening uptake was 1.8-fold (ITT; p=0.1132) or 3-fold (PP; p<0.01) higher in arm A versus arm B. Conclusions Pap and HPV self-sampling were compared in a marginalised, Canadian population. Results indicated a preference for self-sampling. More research on how to reach underscreened Indigenous women is necessary. Trial registration number ISRCTN84617261. PMID:27855089

Randomized Phase II Study of Carboplatin and Paclitaxel With Either Linifanib or Placebo for Advanced Nonsquamous Non–Small-Cell Lung Cancer

PubMed Central

Ramalingam, Suresh S.; Shtivelband, Mikhail; Soo, Ross A.; Barrios, Carlos H.; Makhson, Anatoly; Segalla, José G.M.; Pittman, Kenneth B.; Kolman, Petr; Pereira, Jose R.; Srkalovic, Gordan; Belani, Chandra P.; Axelrod, Rita; Owonikoko, Taofeek K.; Qin, Qin; Qian, Jiang; McKeegan, Evelyn M.; Devanarayan, Viswanath; McKee, Mark D.; Ricker, Justin L.; Carlson, Dawn M.; Gorbunova, Vera A.

2015-01-01

Purpose Linifanib, a potent, selective inhibitor of vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF) receptors, has single-agent activity in non–small-cell lung cancer (NSCLC). We evaluated linifanib with carboplatin and paclitaxel as first-line therapy of advanced nonsquamous NSCLC. Patients and Methods Patients with stage IIIB/IV nonsquamous NSCLC were randomly assigned to 3-week cycles of carboplatin (area under the curve 6) and paclitaxel (200 mg/m2) with daily placebo (arm A), linifanib 7.5 mg (arm B), or linifanib 12.5 mg (arm C). The primary end point was progression-free survival (PFS); secondary efficacy end points included overall survival (OS) and objective response rate. Results One hundred thirty-eight patients were randomly assigned (median age, 61 years; 57% men; 84% smokers). Median PFS times were 5.4 months (95% CI, 4.2 to 5.7 months) in arm A (n = 47), 8.3 months (95% CI, 4.2 to 10.8 months) in arm B (n = 44), and 7.3 months (95% CI, 4.6 to 10.8 months) in arm C (n = 47). Hazard ratios (HRs) for PFS were 0.51 for arm B versus A (P = .022) and 0.64 for arm C versus A (P = .118). Median OS times were 11.3, 11.4, and 13.0 months in arms A, B, and C, respectively. HRs for OS were 1.08 for arm B versus A (P = .779) and 0.88 for arm C versus A (P = .650). Both linifanib doses were associated with increased toxicity, including a higher incidence of adverse events known to be associated with VEGF/PDGF inhibition. Baseline plasma carcinoembryonic antigen/cytokeratin 19 fragments biomarker signature was associated with PFS improvement and a trend toward OS improvement with linifanib 12.5 mg. Conclusion Addition of linifanib to chemotherapy significantly improved PFS (arm B), with a modest trend for survival benefit (arm C) and increased toxicity reflective of known VEGF/PDGF inhibitory effects. PMID:25559798

Targeted Muscle Reinnervation for Real-Time Myoelectric Control of Multifunction Artificial Arms

PubMed Central

Kuiken, Todd A.; Li, Guanglin; Lock, Blair A.; Lipschutz, Robert D.; Miller, Laura A.; Stubblefield, Kathy A.; Englehart, Kevin

2011-01-01

Context Improving the function of prosthetic arms remains a challenge, as access to the neural control information for the arm is lost during amputation. We have developed a surgical technique called targeted muscle reinnervation (TMR) which transfers residual arm nerves to alternative muscle sites. After reinnervation, these target muscles produce an electromyogram (EMG) on the surface of the skin that can be measured and used to control prosthetic arms. Objective Assess the performance of TMR upper-limb amputee patients using a pattern-recognition algorithm to decode EMG signals and control prosthetic arm motions. Design Surface EMG signals were recorded on participants and decoded using a pattern-recognition algorithm. The decoding program controlled the movement of a virtual prosthetic arm. Participants were instructed to perform various arm movements, and their abilities to control the virtual prosthetic arm were measured. In addition, TMR patients used the same control system to operate advanced arm prosthesis prototypes. Setting This study was conducted between January 2007 and January 2008 at the Rehabilitation Institute of Chicago. Participants This study included five patients with shoulder disarticulation or transhumeral amputations who received TMR surgery between February 2002 and October 2006. It also included five non-amputee (control) participants. Main Outcome Measure Performance metrics measured during virtual arm movements included motion-selection time, motion-completion time, and motion-completion (or `success') rate. Three of the TMR patients were also able to test advanced arm prostheses. Results TMR patients were able to repeatedly perform 10 different elbow, wrist and hand motions with the virtual prosthetic arm. For TMR patients, the average (standard deviation (SD)) motion-selection and motion-completion times for elbow and wrist movements were 0.22 s (0.06) and 1.29 s (0.15), respectively. These times were 0.06 s and 0.21 s longer than the average times of control participants. For TMR patients, the average (SD) motion-selection and motion-completion times for hand-grasp patterns were 0.38 s (0.12) and 1.54 s (0.27), respectively. TMR patients successfully completed an average (SD) of 96.3% (3.8) of elbow and wrist movements and 86.9% (13.9) of hand movements within 5 s, compared to 100% (0) and 96.7% (4.7) completed by controls. Three of the patients were able to demonstrate the use of this control system in advanced prostheses including motorized shoulders, elbows, wrists and hands. Conclusion These results suggest that reinnervated muscles can produce sufficient EMG information to control advanced artificial arms. PMID:19211469

Designing and Validation of One-Step T-ARMS-PCR for Genotyping the eNOS rs1799983 SNP

PubMed Central

Heidar, Mohammad Mehdi; Khatami, Mehri

2017-01-01

Background: The transversion of G to T (G894T) in human endothelial nitric oxide synthase (eNOS) gene has profound effects such as male infertility, recurrent miscarriage, multiple sclerosis and cardiovascular diseases. Objectives: Development of a new Multiplex Tetra-Primer Amplification Refractory Mutation System - Polymerase Chain Reaction (T-ARMS-PCR) for detection of rs1799983 (G894T) in the human eNOS was sought. Materials and Methods: A T-ARMS-PCR for rs1799983 polymorphism in a single-step PCR was carried out, and the results were confirmed by PCR-RFLP technique in 82 infertile men with varicocele. Results: The results showed that GG (varicocele infertile men), GT and TT genotypes appear to be 53.65%, 34.14%, and 12.19%, respectively. Full accordance between PCR-RFLP and T-ARMS-PCR methods for genotyping of rs1799983 polymorphism was found. Conclusions: This is the first work that describes a rapid, relatively cheap, high throughput detection of G894T polymorphism in eNOS that can be used in large scale clinical studies. PMID:29845071

Designing and Validation of One-Step T-ARMS-PCR for Genotyping the eNOS rs1799983 SNP.

PubMed

Heidar, Mohammad Mehdi; Khatami, Mehri

2017-01-01

Background: The transversion of G to T (G894T) in human endothelial nitric oxide synthase ( eNOS ) gene has profound effects such as male infertility, recurrent miscarriage, multiple sclerosis and cardiovascular diseases. Objectives: Development of a new Multiplex Tetra-Primer Amplification Refractory Mutation System - Polymerase Chain Reaction (T-ARMS-PCR) for detection of rs1799983 (G894T) in the human eNOS was sought. Materials and Methods: A T-ARMS-PCR for rs1799983 polymorphism in a single-step PCR was carried out, and the results were confirmed by PCR-RFLP technique in 82 infertile men with varicocele. Results: The results showed that GG (varicocele infertile men), GT and TT genotypes appear to be 53.65%, 34.14%, and 12.19%, respectively. Full accordance between PCR-RFLP and T-ARMS-PCR methods for genotyping of rs1799983 polymorphism was found. Conclusions: This is the first work that describes a rapid, relatively cheap, high throughput detection of G894T polymorphism in eNOS that can be used in large scale clinical studies.

Effectiveness of provider incentives for anaemia reduction in rural China: a cluster randomised trial

PubMed Central

Luo, Renfu; Zhang, Linxiu; Sylvia, Sean; Shi, Yaojiang; Foo, Patricia; Zhao, Qiran; Martorell, Reynaldo; Medina, Alexis; Rozelle, Scott

2012-01-01

Objectives To test the impact of provider performance pay for anaemia reduction in rural China. Design A cluster randomised trial of information, subsidies, and incentives for school principals to reduce anaemia among their students. Enumerators and study participants were not informed of study arm assignment. Setting 72 randomly selected rural primary schools across northwest China. Participants 3553 fourth and fifth grade students aged 9-11 years. All fourth and fifth grade students in sample schools participated in the study. Interventions Sample schools were randomly assigned to a control group, with no intervention, or one of three treatment arms: (a) an information arm, in which principals received information about anaemia; (b) a subsidy arm, in which principals received information and unconditional subsidies; and (c) an incentive arm, in which principals received information, subsidies, and financial incentives for reducing anaemia among students. Twenty seven schools were assigned to the control arm (1816 students at baseline, 1623 at end point), 15 were assigned to the information arm (659 students at baseline, 596 at end point), 15 to the subsidy arm (726 students at baseline, 667 at end point), and 15 to the incentive arm (743 students at baseline, 667 at end point). Main outcome measures Student haemoglobin concentrations. Results Mean student haemoglobin concentration rose by 1.5 g/L (95% CI –1.1 to 4.1) in information schools, 0.8 g/L (–1.8 to 3.3) in subsidy schools, and 2.4 g/L (0 to 4.9) in incentive schools compared with the control group. This increase in haemoglobin corresponded to a reduction in prevalence of anaemia (Hb <115 g/L) of 24% in incentive schools. Interactions with pre-existing incentives for principals to achieve good academic performance led to substantially larger gains in the information and incentive arms: when combined with incentives for good academic performance, associated effects on student haemoglobin concentration were 9.8 g/L (4.1 to 15.5) larger in information schools and 8.6 g/L (2.1 to 15.1) larger in incentive schools. Conclusions Financial incentives for health improvement were modestly effective. Understanding interactions with other motives and pre-existing incentives is critical. Trial registration number ISRCTN76158086. PMID:22842354

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

Sequential FOLFIRI.3 + Gemcitabine Improves Health-Related Quality of Life Deterioration-Free Survival of Patients with Metastatic Pancreatic Adenocarcinoma: A Randomized Phase II Trial

PubMed Central

Anota, Amélie; Mouillet, Guillaume; Trouilloud, Isabelle; Dupont-Gossart, Anne-Claire; Artru, Pascal; Lecomte, Thierry; Zaanan, Aziz; Gauthier, Mélanie; Fein, Francine; Dubreuil, Olivier; Paget-Bailly, Sophie; Taieb, Julien; Bonnetain, Franck

2015-01-01

Background A randomized multicenter phase II trial was conducted to assess the sequential treatment strategy using FOLFIRI.3 and gemcitabine alternately (Arm 2) compared to gemcitabine alone (Arm 1) in patients with metastatic non pre-treated pancreatic adenocarcinoma. The primary endpoint was the progression-free survival (PFS) rate at 6 months. It concludes that the sequential treatment strategy appears to be feasible and effective with a PFS rate of 43.5% in Arm 2 at 6 months (26.1% in Arm 1). This paper reports the results of the longitudinal analysis of the health-related quality of life (HRQoL) as a secondary endpoint of this study. Methods HRQoL was evaluated using the EORTC QLQ-C30 at baseline and every two months until the end of the study or death. HRQoL deterioration-free survival (QFS) was defined as the time from randomization to a first significant deterioration as compared to the baseline score with no further significant improvement, or death. A propensity score was estimated comparing characteristics of partial and complete responders. Analyses were repeated with inverse probability weighting method using the propensity score. Multivariate Cox regression analyses were performed to identify independent factors influencing QFS. Results 98 patients were included between 2007 and 2011. Adjusting on the propensity score, patients of Arm 2 presented a longer QFS of Global Health Status (Hazard Ratio: 0.52 [0.31-0.85]), emotional functioning (0.35 [0.21–0.59]) and pain (0.50 [0.31 – 0.81]) than those of Arm 1. Conclusion Patients of Arm 2 presented a better HRQoL with a longer QFS than those of Arm 1. Moreover, the propensity score method allows to take into account the missing data depending on patients’ characteristics. Trial registration information Eudract N° 2006-005703-34. (Name of the Trial: FIRGEM). PMID:26010884

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

[Surgical Correction of Scoliosis: Does Intraoperative CT Navigation Prolong Operative Time?

PubMed

Skála-Rosenbaum, J; Ježek, M; Džupa, V; Kadeřábek, R; Douša, P; Rusnák, R; Krbec, M

2016-01-01

PURPOSE OF THE STUDY The aim of the study was to compare the duration of corrective surgery for scoliosis in relation to the intra-operative use of either fluoroscopic or CT navigation. MATERIAL AND METHODS The indication for surgery was adolescent idiopathic scoliosis in younger patients and degenerative scoliosis in middleage or elderly patients. In a retrospective study, treatment outcomes in 43 consecutive patients operated on between April 2011 and April 2014 were compared. Only patients undergoing surgical correction of five or more spinal segments (fixation of six and more vertebrae) were included. RESULTS Transpedicular screw fixation of six to 13 vertebrae was performed under C-arm fluoroscopy guidance in 22 patients, and transpedicular screws were inserted in six to 14 vertebrae using the O-arm imaging system in 21 patients. A total of 246 screws were placed using the C-arm system and 340 screws were inserted using the O-arm system (p < 0.001). The procedures with use of the O-arm system were more complicated and required an average operative time longer by 48% (measured from the first skin incision to the completion of skin suture). However, the mean time needed for one screw placement (the sum of all surgical procedures with the use of a navigation technique divided by the number of screws placed using this technique) was the same in both techniques (19 min). DISCUSSION With good teamwork (surgeons, anaesthesiologists and a radiologist attending to the O-arm system), the time required to obtain one intra-operative CT scan is 3 to 5 minutes. The study showed that the mean time for placement of one screw was identical in both techniques although the average operative time was longer in surgery with O-arm navigation. The 19- minute interval was not the real placement time per screw. It was the sum of all operative times of surgical procedures (from first incision to suture completion including the whole approach within the range of planned stabilization) which used the same navigation technique divided by the number of all screws inserted during the procedures. The longer average operative time in procedures using O-arm navigation was not related to taking intra-operative O-arm scans. The authors consider surgery with an O-arm imaging system to be a safer procedure and use it currently in surgical correction of scoliosis. CONCLUSIONS The study focused on the length of surgery to correct scoliosis performed using either conventional fluoroscopy (C-arm) or intra-operative CT scanning (O-arm) showed that the mean placement time for one screw was identical in both imaging techniques when six or more vertebrae were stabilised. The use of intra-operative CT navigation did not make the surgery longer, and the higher number of inserted screws provides evidence that this technique is safer and allows us to achieve good stability of the correction procedure. Key words: virtual CT guidance, O-arm, scoliosis, transpedicular screw.

Use of the DEKA Arm for amputees with brachial plexus injury: A case series

PubMed Central

Fantini, Christopher; Latlief, Gail; Phillips, Samuel; Sasson, Nicole; Sepulveda, Eve

2017-01-01

Objective Patients with upper limb amputation and brachial plexus injuries have high rates of prosthesis rejection. Study purpose is to describe experiences of subjects with transhumeral amputation and brachial plexus injury, who were fit with, and trained to use, a DEKA Arm. Methods This was a mixed-methods study utilizing qualitative (e.g. interview, survey) and quantitative data (e.g. self-report and performance measures). Subject 1, a current prosthesis user, had a shoulder arthrodesis. Subject 2, not a prosthesis user, had a subluxed shoulder. Both were trained in laboratory and participated in a trial of home use. Descriptive analyses of processes and outcomes were conducted. Results Subject 1 was fitted with the transhumeral configuration (HC) DEKA Arm using a compression release stabilized socket. He had 12 hours of prosthetic training and participated in all home study activities. Subject 1 had improved dexterity and prosthetic satisfaction with the DEKA Arm and reported better quality of life (QOL) at the end of participation. Subject 2 was fit with the shoulder configuration (SC) DEKA Arm using a modified X-frame socket. He had 30 hours of training and participated in 3 weeks of home activities. He reported less functional disability at the end of training as compared to baseline, but encountered personal problems and exacerbation of PTSD symptoms and withdrew from home use portion at 3 weeks. Both subjects reported functional benefits from use, and expressed a desire to receive a DEKA Arm in the future. Discussion This paper reported on two different strategies for prosthetic fitting and their outcomes. The advantages and limitations of each approach were discussed. Conclusion Use of both the HC and SC DEKA Arm for patients with TH amputation and brachial plexus injury was reported. Lessons learned may be instructive to clinicians considering prosthetic choices for future cases. PMID:28628623

A randomized trial to study the comparative efficacy of phenylbutyrate and benzoate on nitrogen excretion and ureagenesis in healthy volunteers

PubMed Central

Nagamani, Sandesh C.S.; Agarwal, Umang; Tam, Allison; Azamian, Mahshid; McMeans, Ann; Didelija, Inka C.; Mohammad, Mahmoud A.; Marini, Juan C.

2017-01-01

Summary Purpose Benzoate and phenylbutyrate are widely used in the treatment of urea cycle disorders, but detailed studies on pharmacokinetics and comparative efficacy on nitrogen excretion are lacking. Methods We conducted a randomized, three arm, crossover trial in healthy volunteers to study pharmacokinetics and comparative efficacy of phenylbutyrate (NaPB; 7.15 g•m−2BSA•day−1), benzoate (NaBz; 5.5 g•m−2BSA•day−1), and a combination of two medications (MIX arm; 3.575 g NaPB and 2.75 g NaBz•m−2BSA•day−1) on nitrogen excretion. Stable isotopes were used to study effects on urea production and dietary nitrogen disposal. Results The conjugation efficacy for both phenylbutyrate and benzoate was 65%; conjugation was superior at the lower dose used in the MIX arm. Whereas NaPB and MIX treatments were more effective at excreting nitrogen than NaBz, nitrogen excretion as a drug conjugate was similar between phenylbutyrate and MIX arms. Nitrogen-excreted-per-USD was higher with combination therapy compared to NaPB. Conclusions Phenylbutyrate was more effective than benzoate at disposing nitrogen. Increasing phenylbutyrate dose may not result in higher nitrogen excretion due to decreased conjugation efficiency at higher doses. Combinatorial therapy with phenylbutyrate and benzoate has the potential to significantly decrease treatment cost without compromising the nitrogen disposal efficacy. PMID:29693650

Axillary nerve course and position in the fetal period

PubMed Central

Uluer, Tuğba; Aktekin, Mustafa; Kurtoğlu, Zeliha; Buluklu, Semih; Karşıyaka, Dilan; Can, Erdem

2015-01-01

Objectives: To examine the fetal axillary nerve to reveal and compare its morphometric features within the second and third trimester. Methods: This study was conducted at the Anatomy Department, School of Medicine, Mersin University, Mersin, Turkey. Thirty-five fetal shoulders were studied to provide anatomic data and to describe its position with regard to certain landmarks around the shoulder. Results: The shortest distance between the axillary nerve and the glenoid labrum was found 2.27 mm and 2.89 mm in the second and third trimester fetuses, respectively. The shortest distances between the anterior and posterior acromial tips and the axillary nerve were also measured and were used with arm length measurements to define the anterior and posterior indexes. Conclusion: The indexes show that the distance between the axillary nerve and the anterior/posterior acromial tips are approximately one-fourth of the arm length in both the second and third trimester fetuses. The data presented in this study will be of use to surgeons, particularly to pediatric and orthopedic surgeons who will undertake surgical procedures in the axilla and arm in the newborn or early childhood. PMID:26492124

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

The Addition of SPECT/CT Lymphoscintigraphy to Breast Cancer Radiation Planning Spares Lymph Nodes Critical for Arm Drainage

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

Cheville, Andrea L., E-mail: Cheville.andrea@mayo.edu; Brinkmann, Debra H.; Ward, Shelly B.

2013-03-15

Background: This prospective cohort study was designed to determine whether the amount of radiation delivered to the nonpathological lymph nodes (LNs) that drain the arm can be significantly reduced by integrating single-photon emission computed tomography (SPECT)/computed tomography (CT) scans into radiation treatment planning. Methods: SPECT-CT scans were acquired for the 28 patients with stage I or II breast cancer and fused with the routinely obtained radiation oncology planning CT scans. Arm-draining LNs were contoured with 0.5-cm margins automatically using a threshold of 50% maximum intensity. Two treatment plans were generated: 1 per routine clinical practice (standard; STD) and the secondmore » (modified; MOD) with treatment fields modified to minimize dose to the arm-draining LNs visible on SPECT/CT images without interfering with the dosage delivered to target tissues. Participants were treated per the MOD plans. Arm volumes were measured prior to radiation and thereafter at least three subsequent 6-month intervals. Results: Sixty-eight level I-III arm-draining LNs were identified, 57% of which were inside the STD plan fields but could be blocked in the MOD plan fields. Sixty-five percent of arm-draining LNs in the STD versus 16% in the MOD plans received a mean of ≥10 Gy, and 26% in the STD versus 4% in the MOD plans received a mean of ≥40 Gy. Mean LN radiation exposure was 23.6 Gy (standard deviation 18.2) with the STD and 7.7 Gy (standard deviation 11.3) with the MOD plans (P<.001). No participant developed lymphedema. Conclusions: The integration of SPECT/CT scans into breast cancer radiation treatment planning reduces unnecessary arm-draining LN radiation exposure and may lessen the risk of lymphedema.« less

PAX-FOXO1 Fusion Status Drives Unfavorable Outcome for Children With Rhabdomyosarcoma: A Children’s Oncology Group Report

PubMed Central

Skapek, Stephen X.; Anderson, James; Barr, Frederic G.; Bridge, Julia A.; Gastier-Foster, Julie M.; Parham, David M.; Rudzinski, Erin R.; Triche, Timothy; Hawkins, Douglas S.

2015-01-01

Background Rhabdomyosarcoma (RMS) is divided into two major histological subtypes: alveolar (ARMS) and embryonal (ERMS), with most ARMS expressing one of two oncogenic genes fusing PAX3 or PAX7 with FOXO1 (P3F and P7F, respectively). The Children’s Oncology Group (COG) carried out a multi-institutional clinical trial to evaluate the prognostic value of PAX-FOXO1 fusion status. Methods Study participants were treated on COG protocol D9803 for intermediate risk ARMS or ERMS using multi-agent chemotherapy, radiotherapy, and surgery. Central diagnostic pathology review and molecular testing for fusion genes were carried out on prospectively collected specimens. Event-free (EFS) and overall survival (OS) at 5 years were correlated with histological subtype and PAX-FOXO1 status. Results Of 616 eligible D9803 enrollees, 434 cases had adequate clinical, molecular, and pathology data for definitive classification as ERMS, ARMS P3F+ or P7F+, or ARMSn (without detectable fusion). EFS was worse for those with ARMS P3F+ (54%) and P7F+ (65%) than those with ERMS (77%; P < 0.001). EFS for ARMSn and ERMS were not statistically different (90% vs. 77%, P = 0.15). ARMS P3F+had poorer OS (64%) than ARMS P7F+ (87%), ARMSn (89%), and ERMS (82%; P = 0.006). Conclusions ARMSn has an outcome similar to ERMS and superior EFS compared to ARMS with either P3F or P7F, when given therapy designed for children with intermediate risk RMS. This prospective analysis supports incorporation of PAX-FOXO1 fusion status into risk stratification and treatment allocation. PMID:23526739

RANDOMIZED TRIAL OF PEGYLATED LIPOSOMAL DOXORUBICIN (PLD) PLUS CARBOPLATIN VERSUS CARBOPLATIN IN PLATINUM-SENSITIVE (PS) PATIENTS WITH RECURRENT EPITHELIAL OVARIAN OR PERITONEAL CARCINOMA AFTER FAILURE OF INITIAL PLATINUM-BASED CHEMOTHERAPY (SOUTH WEST ONCOLOGY GROUP PROTOCOL S0200)

PubMed Central

Alberts, David S.; Liu, P. Y.; Wilczynski, Sharon P.; Clouser, Mary C.; Lopez, Ana Maria; Michelin, David P.; Lanzotti, Victor J.; Markman, Maurie

2008-01-01

Objective Because debate continues over the role of combination, platinum-based chemotherapy for platinum sensitive (PS), recurrent ovarian cancer (OC), we compared overall survival (OS), progression-free survival (PFS), confirmed complete response rate and time to treatment failure in this population. Methods Patients with recurrent stage III or IV OC, a progression-free and platinum-free interval of 6- 24 months after first-line platinum-based chemotherapy and up to 12 courses of a non-platinum containing consolidation treatment were eligible. Patients were randomized to IV pegylated liposomal doxorubicin (PLD) (30 mg/m2) plus IV carboplatin (AUC=5 mg/mL × min) once every 4 weeks (PLD arm) or IV carboplatin alone (AUC=5mg/mL × min) once every 4 weeks. Results The PLD arm enrolled 31 patients and the carboplatin alone arm 30 for a total of 61 patients out of 900 planned. Response rates were 67% for the PLD arm and 32% for the carboplatin only arm (Fisher’s exact p=0.02). The estimated median PFS was 12 and 8 months for PLD versus carboplatin alone. The estimated median OS on the PLD arm was 26 months and 18 months on the carboplatin only arm (p=0.02). Twenty-six percent of the patients on the PLD arm reported grade 4 toxicities, all hematological in nature. Conclusion This study was closed early because of slow patient accrual. The response rate, median PFS and OS results are intriguing. These data suggest that there may be an advantage to the PLD plus carboplatin combination treatment in patients with PS, recurrent OC. The regimen should be further tested. PMID:17949799

Phase I Trial of Aflibercept (VEGF Trap) with Radiation Therapy and Concomitant and Adjuvant Temozolomide in Patients with High-Grade Gliomas

PubMed Central

Nayak, Lakshmi; de Groot, John; Wefel, Jeffrey S; Cloughesy, Timothy F; Lieberman, Frank; Chang, Susan M; Omuro, Antonio; Drappatz, Jan; Batchelor, Tracy T; DeAngelis, Lisa M; Gilbert, Mark R; Aldape, Kenneth D; Yung, Alfred WK; Fisher, Joy; Ye, Xiaobu; Chen, Alice; Grossman, Stuart; Prados, Michael; Wen, Patrick Y

2017-01-01

Background Anti-vascular endothelial growth factor (VEGF) therapy has shown promise in the treatment of high-grade gliomas (HGG). Aflibercept is a recombinant human fusion protein that acts as a soluble decoy receptor for VEGF-A, VEGF-B and placental growth factor (PlGF), depleting circulating levels of these growth factors. Methods The Adult Brain Tumor Consortium (ABTC) conducted a phase I trial of aflibercept and temozolomide (TMZ) in patients with newly diagnosed high-grade gliomas (HGG) with 2 dose levels and a 3+3 design. Three arms using aflibercept were examined; with radiation and concomitant temozolomide; with adjuvant temozolomide using the 5/28 regimen; and with adjuvant temozolomide using the 21/28 day regimen. Results Fifty-nine patients were enrolled, 21 in arm 1, 20 in arm 2 and 18 in arm 3. Median age was 56 years (24-69); median KPS 90 (60-100). The maximum tolerated dose (MTD) of aflibercept for all 3 arms was 4mg/kg every 2 weeks. Dose limiting toxicities (DLTs) at the MTD were: Arm 1: 0/21 patients; Arm 2: 2/20 patients (G3 deep vein thrombosis, G4 neutropenia; Arm 3: 3/18 patients (G4 biopsy-confirmed thrombotic microangiopathy, G3 rash, G4 thrombocytopenia). The median number of cycles of aflibercept was 5 (range, 1-16). All patients stopped treatment; 28 (47%) for disease progression, 21 (36%) for toxicities, 8 (14%) for other reasons, and 2 (3%) patients completed the full treatment course. Conclusions This study met its primary endpoint and the MTD of aflibercept with radiation and concomitant and adjuvant temozolomide is 4mg/kg every 2 weeks. PMID:28116649

Value of syndromic surveillance within the Armed Forces for early warning during a dengue fever outbreak in French Guiana in 2006

PubMed Central

Meynard, Jean-Baptiste; Chaudet, Hervé; Texier, Gaetan; Ardillon, Vanessa; Ravachol, Françoise; Deparis, Xavier; Jefferson, Henry; Dussart, Philippe; Morvan, Jacques; Boutin, Jean-Paul

2008-01-01

Background A dengue fever outbreak occured in French Guiana in 2006. The objectives were to study the value of a syndromic surveillance system set up within the armed forces, compared to the traditional clinical surveillance system during this outbreak, to highlight issues involved in comparing military and civilian surveillance systems and to discuss the interest of syndromic surveillance for public health response. Methods Military syndromic surveillance allows the surveillance of suspected dengue fever cases among the 3,000 armed forces personnel. Within the same population, clinical surveillance uses several definition criteria for dengue fever cases, depending on the epidemiological situation. Civilian laboratory surveillance allows the surveillance of biologically confirmed cases, within the 200,000 inhabitants. Results It was shown that syndromic surveillance detected the dengue fever outbreak several weeks before clinical surveillance, allowing quick and effective enhancement of vector control within the armed forces. Syndromic surveillance was also found to have detected the outbreak before civilian laboratory surveillance. Conclusion Military syndromic surveillance allowed an early warning for this outbreak to be issued, enabling a quicker public health response by the armed forces. Civilian surveillance system has since introduced syndromic surveillance as part of its surveillance strategy. This should enable quicker public health responses in the future. PMID:18597694

Militarized sexual violence in South Kivu, Democratic Republic of Congo.

PubMed

Bartels, Susan; Kelly, Jocelyn; Scott, Jennifer; Leaning, Jennifer; Mukwege, Denis; Joyce, Nina; VanRooyen, Michael

2013-01-01

Eastern DRC has been the site of a protracted conflict in which sexual violence has been a defining feature. The method used was a retrospective registry-based study of sexual violence survivors presenting to Panzi Hospital between 2004 and 2008. This analysis aimed to describe the patterns of sexual violence described by survivors and to analyze perpetrator profiles. As regards results, a total of 4,311 records were analyzed. Perpetrators in this data set were identified as follows: (a) 6% were civilians; (b) 52% were armed combatants; and (c) 42% were simply identified as "assailant(s)" with no further identifying information. Those identified simply as "assailants" perpetrated patterns of sexual violence that were similar to those of armed combatants, suggesting that this group included a large number of armed combatants. Civilian assailants perpetrated a pattern of sexual violence that was distinct from armed combatants. Conclusions are as follows: These data suggest that a high proportion of sexual assaults in South Kivu are perpetrated by armed combatants. Protection of women in South Kivu will require new strategies that take into account the unique nature of sexual violence in DRC. Engaging with local communities, the UN and other aid organizations is necessary to create new context-appropriate protection programs.

Iron-Magnesium Hydroxycarbonate (Fermagate): A Novel Non-Calcium-Containing Phosphate Binder for the Treatment of Hyperphosphatemia in Chronic Hemodialysis Patients

PubMed Central

McIntyre, Christopher W.; Pai, Pearl; Warwick, Graham; Wilkie, Martin; Toft, Alex J.; Hutchison, Alastair J.

2009-01-01

Background and objectives: This phase II study tested the safety and efficacy of fermagate, a calcium-free iron and magnesium hydroxycarbonate binder, for treating hyperphosphatemia in hemodialysis patients. Design, setting, participants, & measurements: A randomized, double-blind, three-arm, parallel-group study compared two doses of fermagate (1 g three times daily or 2 g three times daily with placebo). Sixty-three patients who had been on a stable hemodialysis regimen for ≥3 mo were randomized to the treatment phase. Study medication was administered three times daily just before meals for 21 d. The primary endpoint was reduction in serum phosphate over this period. Results: In the intention-to-treat analysis, mean baseline serum phosphate was 2.16 mmol/L. The fermagate 1- and 2-g three-times-daily treatment arms were associated with statistical reductions in mean serum phosphate to 1.71 and 1.47 mmol/L, respectively. Adverse event (AE) incidence in the 1-g fermagate arm was statistically comparable to the placebo group. The 2-g arm was associated with a statistically higher number of patients reporting AEs than the 1-g arm, particularly gastrointestinal AEs, as well as a higher number of discontinuations, complicating interpretation of this dose's efficacy. Both doses were associated with elevations of prehemodialysis serum magnesium levels. Conclusions: The efficacy and tolerability of fermagate were dose dependent. Fermagate showed promising efficacy in the treatment of hyperphosphatemia in chronic hemodialysis patients as compared with placebo in this initial phase II study. The optimal balance between efficacy and tolerability needs to be determined from future dose-titration studies, or fixed-dose comparisons of more doses. PMID:19158369

The Effect of Single or Repeated Home Visits on the Hanging and Use of Insecticide-Treated Mosquito Nets following a Mass Distribution Campaign - A Cluster Randomized, Controlled Trial

PubMed Central

Kilian, Albert; Balayo, Connie; Feldman, Mitra; Koenker, Hannah; Lokko, Kojo; Ashton, Ruth A.; Bruce, Jane; Lynch, Matthew; Boulay, Marc

2015-01-01

Background Study objective was to evaluate the effectiveness of commonly used post-campaign hang-up visits on the hanging and use of campaign nets. Methods A cluster-randomized trial was carried out in Uganda following an ITN distribution campaign. Five clusters (parishes, consisting of ∼11 villages each) were randomly selected for each of the three study arms with between 7,534 and 9,401 households per arm. Arm 1 received one hang-up visit, while Arm 2 received two visits by volunteers four and seven months after the campaign. Visits consisted of assistance hanging the net and education on net use. The control arm was only exposed to messages during the campaign itself. Three cross-sectional surveys with a two-stage cluster sampling design, representative of the study populations, were carried out to capture the two key outcome variables of net hanging and ITN use. Sample size was calculated to detect at least a 15 percentage-points change in net use, and was 1811 at endline. The analysis used an intention-to-treat approach. Findings Both hanging and use of ITN increased during follow-up in a similar way in all three study arms. The proportion of the population using an ITN the previous night was 64.0% (95% CI 60.8, 67.2), for one additional visit, 68.2% (63.8, 72.2) for two visits and 64.0% (59.4, 68.5) for the control. The proportion of households with all campaign nets hanging increased from 55.7% to 72.5% at endline (p<0.0005 for trend), with no difference between study arms. Financial cost per household visited was estimated as USD 2.33 for the first visit and USD 2.24 for the second. Conclusions Behavior change communication provided during the campaign or through other channels was sufficient to induce high levels of net hanging and use and additional “hang-up” activities were not cost-effective. PMID:25774676

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

PubMed Central

Holden, John

2016-01-01

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

Randomized, Phase II Study of the Insulin-Like Growth Factor-1 Receptor Inhibitor IMC-A12, With or Without Cetuximab, in Patients With Cetuximab- or Panitumumab-Refractory Metastatic Colorectal Cancer

PubMed Central

Reidy, Diane Lauren; Vakiani, Efsevia; Fakih, Marwan G.; Saif, Muhammad Wasif; Hecht, Joel Randolph; Goodman-Davis, Noah; Hollywood, Ellen; Shia, Jinru; Schwartz, Jonathan; Chandrawansa, Kumari; Dontabhaktuni, Aruna; Youssoufian, Hagop; Solit, David B.; Saltz, Leonard B.

2010-01-01

Purpose To evaluate the safety and efficacy of IMC-A12, a human monoclonal antibody (mAb) that blocks insulin-like growth factor receptor-1 (IGF-1R), as monotherapy or in combination with cetuximab in patients with metastatic refractory anti–epidermal growth factor receptor (EGFR) mAb colorectal cancer. Methods A randomized, phase II study was performed in which patients in arm A received IMC-A12 10 mg/kg intravenously (IV) every 2 weeks, while patients in arm B received this same dose of IMC-A12 plus cetuximab 500 mg/m2 IV every 2 weeks. Subsequently, arm C (same combination treatment as arm B) was added to include patients who had disease control on a prior anti-EGFR mAb and wild-type KRAS tumors. Archived pretreatment tumor tissue was obtained when possible for KRAS, PIK3CA, and BRAF genotyping, and immunohistochemistry was obtained for pAKT as well as IGF-1R. Results Overall, 64 patients were treated (median age, 61 years; range, 40 to 84 years): 23 patients in arm A, 21 in arm B, and 20 in arm C. No antitumor activity was seen in the 23 patients treated with IMC-A12 monotherapy. Of the 21 patients randomly assigned to IMC-A12 plus cetuximab, one patient (with KRAS wild type) achieved a partial response, with disease control lasting 6.5 months. Arm C (all patients with KRAS wild type), however, showed no additional antitumor activity. Serious adverse events thought possibly related to IMC-A12 included a grade 2 infusion-related reaction (2%; one of 64 patients), thrombocytopenia (2%; one of 64 patients), grade 3 hyperglycemia (2%; one of 64 patients), and grade 1 pyrexia (2%, one of 64 patients). Conclusion IMC-A12 alone or in combination with cetuximab was insufficient to warrant additional study in patients with colorectal cancer refractory to EGFR inhibitors. PMID:20713879

Feasibility of oral administration of S-1 as adjuvant chemotherapy in gastric cancer: 4-week S-1 administration followed by 2-week rest vs. 2-week administration followed by 1-week rest

PubMed Central

YAMATSUJI, TOMOKI; FUJIWARA, YASUHIRO; MATSUMOTO, HIDEO; HATO, SHINJI; NAMIKAWA, TSUTOMU; HANAZAKI, KAZUHIRO; TAKAOKA, MUNENORI; HAYASHI, JIRO; SHIGEMITSU, KAORI; YOSHIDA, KAZUHIRO; URAKAMI, ATSUSHI; UNO, FUTOSHI; NISHIZAKI, MASAHIKO; KAGAWA, SHUNSUKE; NINOMIYA, MOTOKI; FUJIWARA, TOSHIYOSHI; HIRAI, TOSHIHIRO; NAKAMURA, MASAFUMI; HAISA, MINORU; NAOMOTO, YOSHIO

2015-01-01

In 2006, the Adjuvant Chemotherapy Trial of S-1 for Gastric Cancer (ACTS-GC) demonstrated that S-1 is an effective adjuvant therapy for gastric cancer. Following that study, S-1 has been used as the standard adjuvant therapy for gastric cancer in Japan. However, the 1-year completion rate was only 65.8% in the ACTS-GC study and feasibility remains a critical issue. We conducted a study to evaluate the feasibility of 2 weekly administration regimens of S-1 as adjuvant chemotherapy in gastric cancer. The criteria for eligibility included histologically proven stage II (excluding T1), IIIA or IIIB gastric cancer with D2 lymph-node dissection. The patients were randomly assigned to either arm A (S-1 administration for 4 weeks followed by 2 weeks of rest) or arm B (S-1 administration for 2 weeks followed by 1 week of rest). In each arm, treatment was continued for 12 months unless recurrence or severe adverse events were observed. The primary endpoint was feasibility (protocol treatment completion rate). The secondary endpoints were safety, relapse-free survival and overall survival. A total of 47 patients were assigned to arms A or B between May, 2008 and February, 2010. During the first interim analysis, the protocol treatment completion rates in arms A and B were 83 and 100%, respectively at 6 months and 49 and 89%, respectively, at 12 months (P=0.0046). Therefore, S-1 administration for 2 weeks followed by 1 week rest was more feasible as adjuvant chemotherapy in gastric cancer. Grade 3 adverse events in arm A included fatigue (8.0%), anorexia (8.0%), nausea (4.0%), vomiting (4.0%) and hand-foot syndrome (4.0%), whereas none were observed in arm B. There were no reported grade 4 adverse events in either arm. In conclusion, the 2-week S-1 administration followed by 1-week rest regimen appears to be a more feasible oral administration regimen for S-1 as adjuvant chemotherapy in gastric cancer. PMID:26137261

Gaia DR1 Evidence of Disrupting the Perseus Arm

NASA Astrophysics Data System (ADS)

Baba, Junichi; Kawata, Daisuke; Matsunaga, Noriyuki; Grand, Robert J. J.; Hunt, Jason A. S.

2018-02-01

We have discovered a clear sign of the disruption phase of the Perseus arm in the Milky Way using Cepheid variables, taking advantage of the accurately measured distances of Cepheids and the proper motions from Gaia Data Release 1. Both the Galactocentric radial and rotation velocities of 77 Cepheids within 1.5 kpc of the Perseus arm are correlated with their distances from the locus of the Perseus arm, as the trailing side is rotating faster and moving inward compared to the leading side. We also found a negative vertex deviation for the Cepheids on the trailing side, ‑27.°6 ± 2.°4, in contrast to the positive vertex deviation in the solar neighborhood. This is, to our knowledge, the first direct evidence that the vertex deviation around the Perseus arm is affected by the spiral arm. We compared these observational trends with our N-body/hydrodynamics simulations based on a static density-wave spiral scenario and with those based on a transient dynamic spiral scenario. Although our comparisons are limited to qualitative trends, they strongly favor the conclusion that the Perseus arm is in the disruption phase of a transient arm.

Salt II: Toward Security or Danger? A Balanced Account of the Key Issues in the Debate.

ERIC Educational Resources Information Center

Irwin, Wallace, Jr., Ed.; And Others

Facts and controversial issues concerning SALT II (Strategic Arms Limitations Talks) are examined. The intent of the document is to enable non-specialists in military/strategic matters to arrive at their own conclusions. Central questions explored are: Is it possible to arrive at an agreement that will stabilize strategic arms competition and…

First-Line Therapy for Human Cutaneous Leishmaniasis in Peru Using the TLR7 Agonist Imiquimod in Combination with Pentavalent Antimony

PubMed Central

Miranda-Verastegui, Cesar; Tulliano, GianFranco; Gyorkos, Theresa W.; Calderon, Wessmark; Rahme, Elham; Ward, Brian; Cruz, Maria; Llanos-Cuentas, Alejandro; Matlashewski, Greg

2009-01-01

Background Current therapies for cutaneous leishmaniasis are limited by poor efficacy, long-term course of treatment, and the development of resistance. We evaluated if pentavalent antimony (an anti-parasitic drug) combined with imiquimod (an immunomodulator) was more effective than pentavalent antimony alone in patients who had not previously been treated. Methods A randomized double-blind clinical trial involving 80 cutaneous leishmaniasis patients was conducted in Peru. The study subjects were recruited in Lima and Cusco (20 experimental and 20 control subjects at each site). Experimental arm: Standard dose of pentavalent antimony plus 5% imiquimod cream applied to each lesion three times per week for 20 days. Control arm: Standard dose of pentavalent antimony plus placebo (vehicle cream) applied as above. The primary outcome was cure defined as complete re-epithelization with no inflammation assessed during the 12 months post-treatment period. Results Of the 80 subjects enrolled, 75 completed the study. The overall cure rate at the 12-month follow-up for the intention-to-treat analysis was 75% (30/40) in the experimental arm and 58% (23/40) in the control arm (p = 0.098). Subgroup analyses suggested that combination treatment benefits were most often observed at the Cusco site, where L. braziliensis is the prevalent species. Over the study period, only one adverse event (rash) was recorded, in the experimental arm. Conclusion The combination treatment of imiquimod plus pentavalent antimony performed better than placebo plus pentavalent antimony, but the difference was not statistically significant. Trial Registration Clinical Trials.gov NCT00257530 PMID:19636365

Gender-Specific Intervention to Reduce Underage Drinking Among Early Adolescent Girls: A Test of a Computer-Mediated, Mother-Daughter Program*

PubMed Central

Schinke, Steven P.; Cole, Kristin C. A.; Fang, Lin

2009-01-01

Objective: This study evaluated a gender-specific, computer-mediated intervention program to prevent underage drinking among early adolescent girls. Method: Study participants were adolescent girls and their mothers from New York, New Jersey, and Connecticut. Participants completed pretests online and were randomly divided between intervention and control arms. Intervention-arm girls and their mothers interacted with a computer program aimed to enhance mother-daughter relationships and to teach girls skills for managing conflict, resisting media influences, refusing alcohol and drugs, and correcting peer norms about underage drinking, smoking, and drug use. After intervention, all participants (control and intervention) completed posttest and follow-up measurements. Results: Two months following program delivery and relative to control-arm participants, intervention-arm girls and mothers had improved their mother-daughter communication skills and their perceptions and applications of parental monitoring and rule-setting relative to girls' alcohol use. Also at follow-up, intervention-arm girls had improved their conflict management and alcohol use-refusal skills; reported healthier normative beliefs about underage drinking; demonstrated greater self-efficacy about their ability to avoid underage drinking; reported less alcohol consumption in the past 7 days, 30 days, and year; and expressed lower intentions to drink as adults. Conclusions: Study findings modestly support the viability of a mother-daughter, computer-mediated program to prevent underage drinking among adolescent girls. The data have implications for the further development of gender-specific approaches to combat increases in alcohol and other substance use among American girls. PMID:19118394

Local Treatment of Unresectable Colorectal Liver Metastases: Results of a Randomized Phase II Trial

PubMed Central

Van Coevorden, Frits; Punt, Cornelis J. A.; Pierie, Jean-Pierre E. N.; Borel-Rinkes, Inne; Ledermann, Jonathan A.; Poston, Graeme; Bechstein, Wolf; Lentz, Marie-Ange; Mauer, Murielle; Folprecht, Gunnar; Van Cutsem, Eric; Ducreux, Michel; Nordlinger, Bernard

2017-01-01

Background: Tumor ablation is often employed for unresectable colorectal liver metastases. However, no survival benefit has ever been demonstrated in prospective randomized studies. Here, we investigate the long-term benefits of such an aggressive approach. Methods: In this randomized phase II trial, 119 patients with unresectable colorectal liver metastases (n < 10 and no extrahepatic disease) received systemic treatment alone or systemic treatment plus aggressive local treatment by radiofrequency ablation ± resection. Previously, we reported that the primary end point (30-month overall survival [OS] > 38%) was met. We now report on long-term OS results. All statistical tests were two-sided. The analyses were according to intention to treat. Results: At a median follow up of 9.7 years, 92 of 119 (77.3%) patients had died: 39 of 60 (65.0%) in the combined modality arm and 53 of 59 (89.8%) in the systemic treatment arm. Almost all patients died of progressive disease (35 patients in the combined modality arm, 49 patients in the systemic treatment arm). There was a statistically significant difference in OS in favor of the combined modality arm (hazard ratio [HR] = 0.58, 95% confidence interval [CI] = 0.38 to 0.88, P = .01). Three-, five-, and eight-year OS were 56.9% (95% CI = 43.3% to 68.5%), 43.1% (95% CI = 30.3% to 55.3%), 35.9% (95% CI = 23.8% to 48.2%), respectively, in the combined modality arm and 55.2% (95% CI = 41.6% to 66.9%), 30.3% (95% CI = 19.0% to 42.4%), 8.9% (95% CI = 3.3% to 18.1%), respectively, in the systemic treatment arm. Median OS was 45.6 months (95% CI = 30.3 to 67.8 months) in the combined modality arm vs 40.5 months (95% CI = 27.5 to 47.7 months) in the systemic treatment arm. Conclusions: This phase II trial is the first randomized study demonstrating that aggressive local treatment can prolong OS in patients with unresectable colorectal liver metastases. PMID:28376151

Planning Evaluation of C-Arm Cone Beam CT Angiography for Target Delineation in Stereotactic Radiation Surgery of Brain Arteriovenous Malformations

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

Kang, Jun; Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland; Huang, Judy

Purpose: Stereotactic radiation surgery (SRS) is one of the therapeutic modalities currently available to treat cerebral arteriovenous malformations (AVM). Conventionally, magnetic resonance imaging (MRI) and MR angiography (MRA) and digital subtraction angiography (DSA) are used in combination to identify the target volume for SRS treatment. The purpose of this study was to evaluate the use of C-arm cone beam computed tomography (CBCT) in the treatment planning of SRS for cerebral AVMs. Methods and Materials: Sixteen consecutive patients treated for brain AVMs at our institution were included in this retrospective study. Prior to treatment, all patients underwent MRA, DSA, and C-arm CBCT.more » All images were coregistered using the GammaPlan planning system. AVM regions were delineated independently by 2 physicians using either C-arm CBCT or MRA, resulting in 2 volumes: a CBCT volume (VCBCT) and an MRA volume (V{sub MRA}). SRS plans were generated based on the delineated regions. Results: The average volume of treatment targets delineated using C-arm CBCT and MRA were similar, 6.40 cm{sup 3} and 6.98 cm{sup 3}, respectively (P=.82). However, significant regions of nonoverlap existed. On average, the overlap of the MRA with the C-arm CBCT was only 52.8% of the total volume. In most cases, radiation plans based on V{sub MRA} did not provide adequate dose to the region identified on C-arm CBCT; the mean minimum dose to V{sub CBCT} was 29.5%, whereas the intended goal was 45% (P<.001). The mean volume of normal brain receiving 12 Gy or more in C-arm CBCT-based plans was not greater than in the MRA-based plans. Conclusions: Use of C-arm CBCT images significantly alters the delineated regions of AVMs for SRS planning, compared to that of MRA/MRI images. CT-based planning can be accomplished without increasing the dose to normal brain and may represent a more accurate definition of the nidus, increasing the chances for successful obliteration.« less

The ARAMIS project: a concept robot and technical design.

PubMed

Colizzi, Lucio; Lidonnici, Antonio; Pignolo, Loris

2009-11-01

To describe the ARAMIS (Automatic Recovery Arm Motility Integrated System) project, a concept robot applicable in the neuro-rehabilitation of the paretic upper limb after stroke. Methods, results and conclusion: The rationale and engineering of a state-of-the-art, hardware/software integrated robot system, its mechanics, ergonomics, electric/electronics features providing control, safety and suitability of use are described. An ARAMIS prototype has been built and is now available for clinical tests. It allows the therapist to design neuro-rehabilitative (synchronous or asynchronous) training protocols in which sample exercises are generated by a single exoskeleton (operated by the patient's unaffected arm or by the therapist's arm) and mirrored in real-time or offline by the exoskeleton supporting the paretic arm.

Molecular identification of Gd A- and Gd B- G6PD deficient variants by ARMS-PCR in a Tunisian population.

PubMed

Haloui, Sabrine; Laouini, Naouel; Sahli, Chaima Abdelhafidh; Daboubi, Rim; Becher, Mariem; Jouini, Latifa; Kazdaghli, Kalthoum; Tinsa, Faten; Cherif, Semia; Khemiri, Monia; Fredj, Sondess Hadj; Othmani, Rim; Ouali, Faida; Siala, Hajer; Toumi, Nour El Houda; Barsaoui, Sihem; Bibi, Amina; Messaoud, Taieb

2016-01-01

Glucose-6-phosphate dehydrogenase (G6PD) deficiency is the most common enzymopathy. More than 200 mutations in the G6PD gene have been described. In Tunisia, the A-African and the B-Mediterranean mutations predominate the mutational spectrum. The purpose of this study was to apply the amplification refractory mutation system (ARMS-PCR) to the identification of Gd A+, Gd A- and Gd B- variants in a cohort of deficient individuals and to establish a phenotype/genotype association. 90 subjects were screened for enzymatic deficiency by spectrophotometric assay. The molecular analyses were performed in a group of 50 unrelated patients. Of the 54 altered chromosomes examined, 60% had the Gd A- mutation, 18% showed the Gd B- mutation and in 20% of cases, no mutations have been identified. The ARMS-PCR showed complete concordance with the endonuclease cleavage reference method and agreed perfectly with previous Tunisian studies where Gd A- and Gd B- were the most encountered. Also, similarities in spectrum mutations with North African and Mediterranean countries suggest gene migration from Africa to Europe through Spain. In conclusion, ARMS has been introduced in this study for common G6PD alleles identification in Tunisia. It gives some advantages compared to the traditional endonuclease digestion method since it is more convenient and timesaving and also offers the possibility to be applied in mass screening surveys.

Statistical Approaches to Adjusting Weights for Dependent Arms in Network Meta-analysis.

PubMed

Su, Yu-Xuan; Tu, Yu-Kang

2018-05-22

Network meta-analysis compares multiple treatments in terms of their efficacy and harm by including evidence from randomized controlled trials. Most clinical trials use parallel design, where patients are randomly allocated to different treatments and receive only one treatment. However, some trials use within person designs such as split-body, split-mouth and cross-over designs, where each patient may receive more than one treatment. Data from treatment arms within these trials are no longer independent, so the correlations between dependent arms need to be accounted for within the statistical analyses. Ignoring these correlations may result in incorrect conclusions. The main objective of this study is to develop statistical approaches to adjusting weights for dependent arms within special design trials. In this study, we demonstrate the following three approaches: the data augmentation approach, the adjusting variance approach, and the reducing weight approach. These three methods could be perfectly applied in current statistic tools such as R and STATA. An example of periodontal regeneration was used to demonstrate how these approaches could be undertaken and implemented within statistical software packages, and to compare results from different approaches. The adjusting variance approach can be implemented within the network package in STATA, while reducing weight approach requires computer software programming to set up the within-study variance-covariance matrix. This article is protected by copyright. All rights reserved.

Comparison Perioperative Factors During Minimally Invasive Pre-Psoas Lateral Interbody Fusion of the Lumbar Spine Using Either Navigation or Conventional Fluoroscopy

PubMed Central

Zhang, Yue-Hui; White, Ian; Potts, Eric; Mobasser, Jean-Pierre

2017-01-01

Study Design: Retrospective clinical study. Objectives: The aim of this study was to compare intraoperative conditions and clinical results of patients undergoing pre-psoas oblique lateral interbody fusion (OLIF) using navigation or conventional fluoroscopy (C-ARM) techniques. Methods: Forty-two patients (22 patients by navigation and 20 by fluoroscopy) underwent the OLIF procedure at 2 medical centers, and records were reviewed. Clinical data was collected and compared between the 2 groups. Patients were followed-up with a range of 6 to 24 months. Results: There were no significant differences on demographic data between groups. The navigation group had zero radiation exposure (RE) to the surgeon and radiation time compared to the C-ARM group, with total RE of 44.59 ± 26.65 mGy and radiation time of 88.30 ± 58.28 seconds (P < .05). The RE to the patient was significantly lower in the O-ARM group (9.38 mGy) compared to the C-ARM group (44.59 ± 26.65 mGy). Operating room time was slightly longer in the navigation group (2.49 ± 1.35 hours) compared to the C-ARM group (2.30 ± 1.17 hours; P > .05), although not statistically significant. No differences were found in estimated blood loss, length of hospitalization, surgery-related complications, and outcome scores with an average of 8-month follow-up. Conclusions: Compared with C-ARM techniques, using navigation can eliminate RE to surgeon and decrease RE to the patient, and it had no significant effect on operating time, estimated blood loss, length of hospitalization, or perioperative complications in the patients with OLIF procedure. This study shows that navigation is a safe alternative to fluoroscopy during the OLIF procedure in the treatment of degenerative lumbar conditions. PMID:28989845

Assessment of Body Composition Using Dual Energy X-Ray Absorptiometry in Patients with Liver Cirrhosis: Comparison with Anthropometry

PubMed Central

Jeong, Seong Han; Lee, Jeong A; Kim, Jin A; Lee, Mun Woo; Chae, Hee Bok; Choi, Won Jun; Shin, Hyoung Shik; Lee, Ki Hyeong; Youn, Sei Jin; Koong, Sung Soo; Park, Seon Mee

1999-01-01

Objectives The aim of this study was to evaluate changes of body composition in cirrhotic patients. Dual energy x-ray absorptiometry (DEXA) and anthropometry were used, and the values obtained were compared. Methods Mid-arm fat and muscle areas were calculated by anthropometry in 66 cirrhotic patients and 94 healthy controls. In 37 of the cirrhotic patients and 39 of the controls, fat mass, lean soft tissue mass and bone mineral contents were measured with DEXA. Results The number of cirrhotic patients with measured values below the fifth percentile of normal controls was 21 (31.8%) by mid-arm fat area, six (9.1%) by mid-arm muscle area, 15 (40.5%) by fat mass and 0 (0%) by lean soft tissue mass. The fat mass in cirrhotic patients was less than in controls, whereas lean soft tissue mass and bone mineral content were not different. Fat depletion was severe in Child-class C patients and with severe ascites. Mid-arm fat area and fat mass showed close correlation (r = 0.85, p<0.01), but mid-arm muscle area and lean soft tissue mass showed poor correlation (r = 0.32, p<0.05). Conclusion Cirrhotic patients showed lower fat component, with preserved lean soft tissue mass and bone mineral content. In clinical practice, the measurement of mid-arm fat area was useful for the assessment of fat mass. PMID:10461427

Protective effects of Tualang honey on bone structure in experimental postmenopausal rats.

PubMed

Zaid, Siti Sarah Mohamad; Sulaiman, Siti Amrah; Othman, Nor Hayati; Soelaiman, Ima-Nirwana; Shuid, Ahmad Nazrun; Mohamad, Norazlina; Muhamad, Norliza

2012-07-01

The objective of this study was to evaluate the effects of Tualang honey on trabecular structure and compare these effects with those of calcium supplementation in ovariectomized rats. Forty female, Sprague-Dawley rats were randomly divided into five groups (n =8): four controls and one test arm. The control arm comprised a baseline control, sham-operated control, ovariectomized control, and ovariectomized calcium-treated rats (receiving 1% calcium in drinking water ad libitum). The test arm was composed of ovariectomized, Tualang honey-treated rats (received 0.2 g/kg body weight of Tualang honey). Both the sham-operated control and ovariectomized control groups received vehicle treatment (deionized water), and the baseline control group was sacrificed without treatment. All rats were orally gavaged daily for six weeks after day one post-surgery. The bone structural analysis of rats in the test arm group showed a significant increase in the bone volume per tissue volume (BV/TV), trabecular thickness (Tb.Th) and trabecular number (Tb.N) and a significant decrease in inter-trabecular space (Tb.Sp) compared with the ovariectomized control group. The trabecular thickness (Tb.Th) in the test arm group was significantly higher compared with the ovariectomized-calcium treated group, and the inter-trabecular space (Tb.Sp) in the test arm group was significantly narrower compared with the ovariectomized-calcium treated group. In conclusion, ovariectomized rats that received Tualang honey showed more improvements in trabecular bone structure than the rats that received calcium.

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.

Dasatinib 100 mg Once Daily Minimizes the Occurrence of Pleural Effusion in Patients With Chronic Myeloid Leukemia in Chronic Phase and Efficacy Is Unaffected in Patients who Develop Pleural Effusion

PubMed Central

Porkka, Kimmo; Khoury, H. Jean; Paquette, Ronald L.; Matloub, Yousif; Sinha, Ritwik; Cortes, Jorge E.

2014-01-01

BACKGROUND Dasatinib, a highly potent BCR-ABL inhibitor, is an effective treatment for patients with chronic myeloid leukemia in chronic phase (CML CP) after resistance, suboptimal response, or intolerance to prior imatinib. In a phase 3 dose optimization trial in patients with CML CP (CA180-034), the occurrence of pleural effusion was significantly minimized with dasatinib 100 mg once daily (QD) compared with other treatment arms (70 mg twice daily [twice daily], 140 mg QD, or 50 mg twice daily). METHODS To investigate the occurrence and management of pleural effusion during dasatinib treatment, and efficacy in patients with or without pleural effusion, data from CA180-034 were analyzed. RESULTS With 24-month minimum follow-up, 14% of patients treated with dasatinib 100 mg QD incurred pleural effusion (grade 3: 2%; grade 4: 0%) compared with 23% to 26% in other study arms. The pleural effusion rate showed only a minimal increment from 12 to 24 months. In the 100 mg QD study arm, median time to pleural effusion (any grade) was 315 days, and after pleural effusion, 52% of patients had a transient dose interruption, 35% had a dose reduction, 57% received a diuretic, and 26% received a corticosteroid. Three patients in the 100 mg QD study arm discontinued treatment after pleural effusion. Across all study arms, patients with or without pleural effusion demonstrated similar progression-free and overall survival, and cytogenetic response rates were higher in patients with a pleural effusion. CONCLUSIONS Pleural effusion is minimized with dasatinib 100 mg QD dosing and its occurrence does not affect short- or long-term efficacy. PMID:19924787

Impact of diagnosis of diabetes on health-related quality of life among high risk individuals: the Diabetes Prevention Program outcomes study

PubMed Central

Pan, Q.; Barrett-Connor, E.; de Groot, M.; Zhang, P.; Percy, C.; Florez, H.; Ackermann, R.; Montez, M.; Rubin, R. R.

2013-01-01

Purpose The purpose of this study is to assess if diagnosis of type 2 diabetes affected health-related quality of life (HRQoL) among participants in the Diabetes Prevention Program/Diabetes Prevention Program Outcome Study and changes with treatment or diabetes duration. Methods 3,210 participants with pre-diabetes were randomized to metformin (MET), intensive lifestyle intervention (ILS), or placebo (PLB). HRQoL was assessed using the SF-36 including: (1) 8 SF-36 subscales; (2) the physical component (PCS) and mental component summary (MCS) scores; and (3) the SF-6D. The sample was categorized by diabetes free versus diagnosed. For diagnosed subgroup, mean scores in the diabetes-free period, at 6 months, 2, 4 and 6 years post-diagnosis, were compared. Results PCS and SF-6D scores declined in all participants in all treatment arms (P <.001). MCS scores did not change significantly in any treatment arm regardless of diagnosis. ILS participants reported a greater decrease in PCS scores at 6 months post-diagnosis (P <.001) and a more rapid decline immediately post-diagnosis in SF-6D scores (P = .003) than the MET or PLB arms. ILS participants reported a significant decrease in the social functioning subscale at 6 months (P <.001) and two years (P <.001) post-diagnosis. Conclusions Participants reported a decline in measures of overall health state (SF-6D) and overall physical HRQoL, whether or not they were diagnosed with diabetes during the study. There was no change in overall mental HRQoL. Participants in the ILS arm with diabetes reported a more significant decline in some HRQoL measures than those in the MET and PLB arms that developed diabetes. PMID:23709097

The effects of upper and lower limb position on symmetry of vertical ground reaction force during sit-to-stand in chronic stroke subjects

PubMed Central

Lee, Jae Hong; Min, Dong Ki; Choe, Han Seong; Lee, Jin Hwan; Shin, So Hong

2018-01-01

[Purpose] The purpose of this study was to evaluate the influence of arm and leg posture elements on symmetrical weight bearing during Sit to Stand tasks in chronic stroke patients. [Subjects and Methods] The subjects were diagnosed with stroke and 22 patients (15 males and 7 females) participated in this study. All participants performed Sit to Stand tasks on three foot postures and two arm postures. Two force plates were used to measure peak of vertical ground reaction force and symmetrical ratio to peak Fz. The data were analyzed using independent t-test and two-way repeated ANOVA. [Results] The results of this study are as follows: 1) Peak Fz placed more weight in non-paretic leg during Sit to Stand. 2) A symmetrical ratio to Peak Fz indicated significant difference between foot and arm posture, and had non-paretic limb supported on a step and paretic at ground level (STP) and grasped arm posture that lock fingers together with shoulder flexion by 90°(GA) (0.79 ± 0.09). [Conclusion] These results suggest that STP posture of the legs and GA posture of the arms should be able to increase the use of the paretic side during Sit to Stand behavior and induce normal Sit to Stand mechanism through the anterior tilt of the hip in clinical practices, by which loads onto the knee joint and the ankle joint can be reduced, and the trunk righting response can be promoted by making the back fully stretched. The outcome of this study is expected to be a reference for exercise or prognosis of Sit to Stand in stroke patients. PMID:29545686

Residual Upper Arm Motor Function Primes Innervation of Paretic Forearm Muscles in Chronic Stroke after Brain-Machine Interface (BMI) Training

PubMed Central

Curado, Marco Rocha; Cossio, Eliana Garcia; Broetz, Doris; Agostini, Manuel; Cho, Woosang; Brasil, Fabricio Lima; Yilmaz, Oezge; Liberati, Giulia; Lepski, Guilherme

2015-01-01

Background Abnormal upper arm-forearm muscle synergies after stroke are poorly understood. We investigated whether upper arm function primes paralyzed forearm muscles in chronic stroke patients after Brain-Machine Interface (BMI)-based rehabilitation. Shaping upper arm-forearm muscle synergies may support individualized motor rehabilitation strategies. Methods Thirty-two chronic stroke patients with no active finger extensions were randomly assigned to experimental or sham groups and underwent daily BMI training followed by physiotherapy during four weeks. BMI sessions included desynchronization of ipsilesional brain activity and a robotic orthosis to move the paretic limb (experimental group, n = 16). In the sham group (n = 16) orthosis movements were random. Motor function was evaluated with electromyography (EMG) of forearm extensors, and upper arm and hand Fugl-Meyer assessment (FMA) scores. Patients performed distinct upper arm (e.g., shoulder flexion) and hand movements (finger extensions). Forearm EMG activity significantly higher during upper arm movements as compared to finger extensions was considered facilitation of forearm EMG activity. Intraclass correlation coefficient (ICC) was used to test inter-session reliability of facilitation of forearm EMG activity. Results Facilitation of forearm EMG activity ICC ranges from 0.52 to 0.83, indicating fair to high reliability before intervention in both limbs. Facilitation of forearm muscles is higher in the paretic as compared to the healthy limb (p<0.001). Upper arm FMA scores predict facilitation of forearm muscles after intervention in both groups (significant correlations ranged from R = 0.752, p = 0.002 to R = 0.779, p = 0.001), but only in the experimental group upper arm FMA scores predict changes in facilitation of forearm muscles after intervention (R = 0.709, p = 0.002; R = 0.827, p<0.001). Conclusions Residual upper arm motor function primes recruitment of paralyzed forearm muscles in chronic stroke patients and predicts changes in their recruitment after BMI training. This study suggests that changes in upper arm-forearm synergies contribute to stroke motor recovery, and provides candidacy guidelines for similar BMI-based clinical practice. PMID:26495971

Incidence of Posttransplantation Diabetes Mellitus in De Novo Kidney Transplant Recipients Receiving Prolonged-Release Tacrolimus-Based Immunosuppression With 2 Different Corticosteroid Minimization Strategies: ADVANCE, A Randomized Controlled Trial

PubMed Central

Mourad, Georges; Glyda, Maciej; Albano, Laetitia; Viklický, Ondrej; Merville, Pierre; Tydén, Gunnar; Mourad, Michel; Lõhmus, Aleksander; Witzke, Oliver; Christiaans, Maarten H. L.; Brown, Malcolm W.; Undre, Nasrullah; Kazeem, Gbenga; Kuypers, Dirk R. J.

2017-01-01

Background ADVANCE (NCT01304836) was a phase 4, multicenter, prospectively randomized, open-label, 24-week study comparing the incidence of posttransplantation diabetes mellitus (PTDM) with 2 prolonged-release tacrolimus corticosteroid minimization regimens. Methods All patients received prolonged-release tacrolimus, basiliximab, mycophenolate mofetil and 1 bolus of intraoperative corticosteroids (0-1000 mg) as per center policy. Patients in arm 1 received tapered corticosteroids, stopped after day 10, whereas patients in arm 2 received no steroids after the intraoperative bolus. The primary efficacy variable was the diagnosis of PTDM as per American Diabetes Association criteria (2010) at any point up to 24 weeks postkidney transplantation. Secondary efficacy variables included incidence of composite efficacy failure (graft loss, biopsy-proven acute rejection or severe graft dysfunction: estimated glomerular filtration rate (Modification of Diet in Renal Disease-4) <30 mL/min per 1.73 m2), acute rejection and graft and patient survival. Results The full-analysis set included 1081 patients (arm 1: n = 528, arm 2: n = 553). Baseline characteristics and mean tacrolimus trough levels were comparable between arms. Week 24 Kaplan–Meier estimates of PTDM were similar for arm 1 versus arm 2 (17.4% vs 16.6%; P = 0.579). Incidence of composite efficacy failure, graft and patient survival, and mean estimated glomerular filtration rate were also comparable between arms. Biopsy-proven acute rejection and acute rejection were significantly higher in arm 2 versus arm 1 (13.6% vs 8.7%, P = 0.006 and 25.9% vs 18.2%, P = 0.001, respectively). Tolerability profiles were comparable between arms. Conclusions A prolonged-release tacrolimus, basiliximab, and mycophenolate mofetil immunosuppressive regimen is efficacious, with a low incidence of PTDM and a manageable tolerability profile over 24 weeks of treatment. A lower incidence of biopsy-proven acute rejection was seen in patients receiving corticosteroids tapered over 10 days plus an intraoperative corticosteroid bolus versus those receiving an intraoperative bolus only. PMID:27547871

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.

Different systolic blood pressure targets for people with history of stroke or transient ischaemic attack: PAST-BP (Prevention After Stroke—Blood Pressure) randomised controlled trial

PubMed Central

McManus, Richard J; Roalfe, Andrea; Fletcher, Kate; Taylor, Clare J; Martin, Una; Virdee, Satnam; Greenfield, Sheila; Hobbs, F D Richard

2016-01-01

Objective To assess whether using intensive blood pressure targets leads to lower blood pressure in a community population of people with prevalent cerebrovascular disease. Design Open label randomised controlled trial. Setting 99 general practices in England, with participants recruited in 2009-11. Participants People with a history of stroke or transient ischaemic attack whose systolic blood pressure was 125 mm Hg or above. Interventions Intensive systolic blood pressure target (<130 mm Hg or 10 mm Hg reduction from baseline if this was <140 mm Hg) or standard target (<140 mm Hg). Apart from the different target, patients in both arms were actively managed in the same way with regular reviews by the primary care team. Main outcome measure Change in systolic blood pressure between baseline and 12 months. Results 529 patients (mean age 72) were enrolled, 266 to the intensive target arm and 263 to the standard target arm, of whom 379 were included in the primary analysis (182 (68%) intensive arm; 197 (75%) standard arm). 84 patients withdrew from the study during the follow-up period (52 intensive arm; 32 standard arm). Mean systolic blood pressure dropped by 16.1 mm Hg to 127.4 mm Hg in the intensive target arm and by 12.8 mm Hg to 129.4 mm Hg in the standard arm (difference between groups 2.9 (95% confidence interval 0.2 to 5.7) mm Hg; P=0.03). Conclusions Aiming for target below 130 mm Hg rather than 140 mm Hg for systolic blood pressure in people with cerebrovascular disease in primary care led to a small additional reduction in blood pressure. Active management of systolic blood pressure in this population using a <140 mm Hg target led to a clinically important reduction in blood pressure. Trial registration Current Controlled Trials ISRCTN29062286. PMID:26919870

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.

The Systolic Blood Pressure Difference Between Arms and Cardiovascular Disease in the Framingham Heart Study

PubMed Central

Weinberg, Ido; Gona, Philimon; O’Donnell, Christopher J.; Jaff, Michael R.; Murabito, Joanne M.

2014-01-01

Background An increased inter-arm systolic blood pressure difference is an easily determined physical examination finding. The relationship between inter-arm systolic blood pressure difference and risk of future cardiovascular disease is uncertain. We described the prevalence and risk factor correlates of inter-arm systolic blood pressure difference in the Framingham Heart Study (FHS) original and offspring cohorts and examined the association between inter-arm systolic blood pressure difference and incident cardiovascular disease and all-cause mortality. Methods An increased inter-arm systolic blood pressure difference was defined as ≥10mmHg using the average of initial and repeat blood pressure measurements obtained in both arms. Participants were followed through 2010 for incident cardiovascular disease events. Multivariable Cox proportional hazards regression analyses were performed to investigate the effect of inter-arm systolic blood pressure difference on incident cardiovascular disease. Results We examined 3,390 (56.3% female) participants aged 40 years and older, free of cardiovascular disease at baseline, mean age of 61.1 years, who attended a FHS examination between 1991 and 1994 (original cohort) and from 1995 to 1998 (offspring cohort). The mean absolute inter-arm systolic blood pressure difference was 4.6 mmHg (range 0 to 78). Increased inter-arm systolic blood pressure difference was present in 317 (9.4%) participants. The median follow-up time was 13.3 years, during which time 598 participants (17.6%) experienced a first cardiovascular event including 83 (26.2%) participants with inter-arm systolic blood pressure difference ≥10 mmHg. Compared to those with normal inter-arm systolic blood pressure difference, participants with an elevated inter-arm systolic blood pressure difference were older (63.0 years vs. 60.9 years), had a greater prevalence of diabetes mellitus (13.3% vs. 7.5%,), higher systolic blood pressure (136.3 mmHg vs. 129.3 mmHg), and a higher total cholesterol level (212.1 mg/dL vs. 206.5 mg/dL). Inter-arm systolic blood pressure difference was associated with a significantly increased hazard of incident cardiovascular events in the multivariable adjusted model (hazard ratio 1.38, 95% CI, 1.09 to 1.75). For each 1-standard deviation unit increase in absolute interarm systolic blood pressure difference, the hazard ratio for incident cardiovascular events was 1.07 (CI, 1.00 to 1.14) in the fully-adjusted model. There was no such association with mortality (hazard ratio 1.02, 95% CI 0.76 to 1.38). Conclusions In this community-based cohort, an inter-arm systolic blood pressure difference is common and associated with a significant increased risk for future cardiovascular events, even when the absolute difference in arm systolic blood pressure is modest. These findings support research to expand clinical use of this simple measurement. PMID:24287007

SU-F-207-03: Dosimetric Effect of the Position of Arms in Torso CT Scan with Tube Current Modulation

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

Liu, H; Rensselaer Polytechnic Institute, Troy, NY; Gao, Y

Purpose: To evaluate the patient organ dose differences between the arms-raised and arms-lowered postures in Torso multidetector computed tomography (MDCT) scan protocols with tube current modulation (TCM). Methods: Patient CT organ doses were simulated using the Monte Carlo method with human phantoms and a validated CT scanner model. A set of adult human phantoms with arms raised and arms lowered postures were developed using advanced BREP-based mesh surface geometries. Organ doses from routine Torso scan protocols such as chest, abdomen-pelvis, and CAP scans were simulated. The organ doses differences caused by two different posutres were investigated when tube current modulationmore » (TCM) were applied during the CT scan. Results: With TCM applied, organ doses of all the listed organs of arms-lowered posture phantom are larger than those of arms raised phantom. The dose difference for most of the organs or tissues are larger than 50%, and the skin doses difference for abdomen-pelvis scan even reaches 112.03%. This is due to the fact that the tube current for patient with arms-lowered is much higher than for the arms raised posture. Conclusion: Considering CT scan with TCM, which is commonly applied clinically, patients who could not raise their arms will receive higher radiation dose than the arms raised patient, with dose differences for some tissues such as the skin being larger than 100%. This is due to the additional tube current necessary to penetrate the arms while maintaining consistent image quality. National Nature Science Foundation of China(No.11475047)« less

Weight Bearing through Lower Limbs in a Standing Frame with and without Arm Support and Low-Magnitude Whole Body Vibration in Men and Women with Complete Motor Paraplegia

PubMed Central

Bernhardt, Kathie A.; Beck, Lisa A.; Lamb, Jeffry L.; Kaufman, Kenton R.; Amin, Shreyasee; Wuermser, Lisa-Ann

2014-01-01

Objective To determine the proportion of body weight (BW) borne through the lower limbs in persons with complete, motor paraplegia using a standing frame, with and without support of their arms. We also examined the effect of low-magnitude whole body vibration on loads borne by the lower extremities. Design Vertical ground reaction forces (GRF) were measured in 11 participants (6 men and 5 women) with paraplegia of traumatic origin (injury level T3 to T12) standing on a low-magnitude vibrating plate using a standing frame. GRF were measured in four conditions: 1) no vibration with arms on standing frame tray; 2) no vibration with arms at side; 3) vibration with arms on tray; 4) vibration with arms at side. Results GRF with arms on tray, without vibration, was 0.76 ± 0.07 BW. With arms at the side, GRF increased to 0.85 ± 0.12 BW. With vibration, mean GRF did not significantly differ from no-vibration conditions for either arm positions. Oscillation of GRF with vibration was significantly different from no-vibration conditions (p<0.001) but similar in both arm positions. Conclusion Men and women with paraplegia using a standing frame bear the majority of their weight through their lower limbs. Supporting their arms on the tray reduces the GRF by ~10% BW. Low-magnitude vibration provided additional oscillation of the load-bearing forces and was proportionally similar regardless of arm position. PMID:22407161

Sequence Composition and Gene Content of the Short Arm of Rye (Secale cereale) Chromosome 1

PubMed Central

Fluch, Silvia; Kopecky, Dieter; Burg, Kornel; Šimková, Hana; Taudien, Stefan; Petzold, Andreas; Kubaláková, Marie; Platzer, Matthias; Berenyi, Maria; Krainer, Siegfried; Doležel, Jaroslav; Lelley, Tamas

2012-01-01

Background The purpose of the study is to elucidate the sequence composition of the short arm of rye chromosome 1 (Secale cereale) with special focus on its gene content, because this portion of the rye genome is an integrated part of several hundreds of bread wheat varieties worldwide. Methodology/Principal Findings Multiple Displacement Amplification of 1RS DNA, obtained from flow sorted 1RS chromosomes, using 1RS ditelosomic wheat-rye addition line, and subsequent Roche 454FLX sequencing of this DNA yielded 195,313,589 bp sequence information. This quantity of sequence information resulted in 0.43× sequence coverage of the 1RS chromosome arm, permitting the identification of genes with estimated probability of 95%. A detailed analysis revealed that more than 5% of the 1RS sequence consisted of gene space, identifying at least 3,121 gene loci representing 1,882 different gene functions. Repetitive elements comprised about 72% of the 1RS sequence, Gypsy/Sabrina (13.3%) being the most abundant. More than four thousand simple sequence repeat (SSR) sites mostly located in gene related sequence reads were identified for possible marker development. The existence of chloroplast insertions in 1RS has been verified by identifying chimeric chloroplast-genomic sequence reads. Synteny analysis of 1RS to the full genomes of Oryza sativa and Brachypodium distachyon revealed that about half of the genes of 1RS correspond to the distal end of the short arm of rice chromosome 5 and the proximal region of the long arm of Brachypodium distachyon chromosome 2. Comparison of the gene content of 1RS to 1HS barley chromosome arm revealed high conservation of genes related to chromosome 5 of rice. Conclusions The present study revealed the gene content and potential gene functions on this chromosome arm and demonstrated numerous sequence elements like SSRs and gene-related sequences, which can be utilised for future research as well as in breeding of wheat and rye. PMID:22328922

An interlaminar tension strength specimen

NASA Technical Reports Server (NTRS)

Jackson, Wade C.; Martin, Roderick H.

1992-01-01

This paper describes a technique to determine interlaminar tension strength, sigma(sub 3c) of a fiber reinforced composite material using a curved beam. The specimen was a unidirectional curved beam, bent 90 degrees, with straight arms. Attached to each arm was a hinged loading mechanism which was held by the grips of a tensile testing machine. Geometry effects of the specimen, including the effects of loading arm length, inner radius, thickness, and width, were studied. The data sets fell into two categories: low strength corresponding to a macroscopic flaw related failure and high strength corresponding to a microscopic flaw related failure. From the data available, the loading arm length had no effect on sigma(sub 3c). The inner radius was not expected to have a significant effect on sigma(sub 3c), but this conclusion could not be confirmed because of differences in laminate quality for each curve geometry. The thicker specimens had the lowest value of sigma(sub 3c) because of poor laminate quality. Width was found to affect the value of sigma(sub 3c) only slightly. The wider specimens generally had a slightly lower strength since more material was under high stress, and hence, had a larger probability of containing a significant flaw.

Site Scientist for the North Slope of Alaska Site

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

Verlinde, Johannes

2016-03-11

Under this grant our team contributed scientific support to the Department of Energy Atmospheric Radiation Program’s (DOE-ARM) Infrastructure team to maintain high quality research data at the DOE-ARM North Slope of Alaska with special emphasis on the radars. Under our guidance two major field campaigns focusing on mixed-phase Arctic clouds were conducted that greatly increased the community’s understanding of the many processes working together to control the evolution of single-layer cloud mixed-phase clouds. A series of modeling and observational studies revealed that the longevity of the radiatively important liquid phase is strongly dependent on how the ice phase develops inmore » mixed-phase clouds. A new ice microphysics parameterization was developed to capture better the natural evolution of ice particle growth in evolving environments. An ice particle scattering database was developed for all ARM radar frequencies. This database was used in a radar simulator (Doppler spectrum and polarimetric variables) to aid in the interpretation of the advanced ARM radars. At the conclusion of this project our team was poised to develop a complete radar simulator consistent with the new microphysical parameterization, taking advantage of parameterization’s advanced characterization of the ice shape and ice density.« less

Surgical Mask to Prevent Influenza Transmission in Households: A Cluster Randomized Trial

PubMed Central

Canini, Laetitia; Andréoletti, Laurent; Ferrari, Pascal; D'Angelo, Romina; Blanchon, Thierry; Lemaitre, Magali; Filleul, Laurent; Ferry, Jean-Pierre; Desmaizieres, Michel; Smadja, Serge; Valleron, Alain-Jacques; Carrat, Fabrice

2010-01-01

Background Facemasks and respirators have been stockpiled during pandemic preparedness. However, data on their effectiveness for limiting transmission are scarce. We evaluated the effectiveness of facemask use by index cases for limiting influenza transmission by large droplets produced during coughing in households. Methodology and Principal Findings A cluster randomized intervention trial was conducted in France during the 2008–2009 influenza season. Households were recruited during a medical visit of a household member with a positive rapid influenza A test and symptoms lasting less than 48 hours. Households were randomized either to the mask or control group for 7 days. In the intervention arm, the index case had to wear a surgical mask from the medical visit and for a period of 5 days. The trial was initially intended to include 372 households but was prematurely interrupted after the inclusion of 105 households (306 contacts) following the advice of an independent steering committee. We used generalized estimating equations to test the association between the intervention and the proportion of household contacts who developed an influenza-like illness during the 7 days following the inclusion. Influenza-like illness was reported in 24/148 (16.2%) of the contacts in the intervention arm and in 25/158 (15.8%) of the contacts in the control arm and the difference between arms was 0.40% (95%CI: −10% to 11%, P = 1.00). We observed a good adherence to the intervention. In various sensitivity analyses, we did not identify any trend in the results suggesting effectiveness of facemasks. Conclusion This study should be interpreted with caution since the lack of statistical power prevents us to draw formal conclusion regarding effectiveness of facemasks in the context of a seasonal epidemic. Trial Registration clinicaltrials.gov NCT00774774 PMID:21103330

Compensatory Versus Noncompensatory Shoulder Movements Used for Reaching in Stroke.

PubMed

Levin, Mindy F; Liebermann, Dario G; Parmet, Yisrael; Berman, Sigal

2016-08-01

Background The extent to which the upper-limb flexor synergy constrains or compensates for arm motor impairment during reaching is controversial. This synergy can be quantified with a minimal marker set describing movements of the arm-plane. Objectives To determine whether and how (a) upper-limb flexor synergy in patients with chronic stroke contributes to reaching movements to different arm workspace locations and (b) reaching deficits can be characterized by arm-plane motion. Methods Sixteen post-stroke and 8 healthy control subjects made unrestrained reaching movements to targets located in ipsilateral, central, and contralateral arm workspaces. Arm-plane, arm, and trunk motion, and their temporal and spatial linkages were analyzed. Results Individuals with moderate/severe stroke used greater arm-plane movement and compensatory trunk movement compared to those with mild stroke and control subjects. Arm-plane and trunk movements were more temporally coupled in stroke compared with controls. Reaching accuracy was related to different segment and joint combinations for each target and group: arm-plane movement in controls and mild stroke subjects, and trunk and elbow movements in moderate/severe stroke subjects. Arm-plane movement increased with time since stroke and when combined with trunk rotation, discriminated between different subject groups for reaching the central and contralateral targets. Trunk movement and arm-plane angle during target reaches predicted the subject group. Conclusions The upper-limb flexor synergy was used adaptively for reaching accuracy by patients with mild, but not moderate/severe stroke. The flexor synergy, as parameterized by the amount of arm-plane motion, can be used by clinicians to identify levels of motor recovery in patients with stroke. © The Author(s) 2015.

Development of a multiplex amplification refractory mutation system reverse transcription polymerase chain reaction assay for the differential diagnosis of Feline leukemia virus vaccine and wild strains.

PubMed

Ho, Chia-Fang; Chan, Kun-Wei; Yang, Wei-Cheng; Chiang, Yu-Chung; Chung, Yang-Tsung; Kuo, James; Wang, Chi-Young

2014-07-01

A multiplex amplification refractory mutation system reverse transcription polymerase chain reaction (ARMS RT-PCR) was developed for the differential diagnosis of Feline leukemia virus (FeLV) vaccine and wild-type strains based on a point mutation between the vaccine strain (S) and the wild-type strain (T) located in the p27 gene. This system was further upgraded to obtain a real-time ARMS RT-PCR (ARMS qRT-PCR) with a high-resolution melt analysis (HRMA) platform. The genotyping of various strains of FeLV was determined by comparing the HRMA curves with the defined wild-type FeLV (strain TW1), and the results were expressed as a percentage confidence. The detection limits of ARMS RT-PCR and ARMS qRT-PCR combined with HRMA were 100 and 1 copies of transcribed FeLV RNA per 0.5 ml of sample, respectively. No false-positive results were obtained with 6 unrelated pathogens and 1 feline cell line. Twelve FeLV Taiwan strains were correctly identified using ARMS qRT-PCR combined with HRMA. The genotypes of the strains matched the defined FeLV wild-type strain genotype with at least 91.17% confidence. A higher degree of sequence polymorphism was found throughout the p27 gene compared with the long terminal repeat region. In conclusion, the current study describes the phylogenetic relationship of the FeLV Taiwan strains and demonstrates that the developed ARMS RT-PCR assay is able to be used to detect the replication of a vaccine strain that has not been properly inactivated, thus acting as a safety check for the quality of FeLV vaccines.

Erlotinib 150 mg daily plus chemotherapy in advanced pancreatic cancer: an interim safety analysis of a multicenter, randomized, cross-over phase III trial of the 'Arbeitsgemeinschaft Internistische Onkologie'.

PubMed

Boeck, Stefan; Vehling-Kaiser, Ursula; Waldschmidt, Dirk; Kettner, Erika; Märten, Angela; Winkelmann, Cornelia; Klein, Stefan; Kojouharoff, Georgi; Gauler, Thomas; Fischer von Weikersthal, Ludwig; Clemens, Michael R; Geissler, Michael; Greten, Tim F; Hegewisch-Becker, Susanna; Neugebauer, Sascha; Heinemann, Volker

2010-01-01

To date, only limited toxicity data are available for the combination of erlotinib with either capecitabine or gemcitabine as front-line therapy for advanced pancreatic cancer. Within a randomized phase III trial, 281 treatment-naive patients were randomly assigned between capecitabine (2000 mg/m/day, for 14 days, once every 3 weeks) plus erlotinib (150 mg/day, arm A) and gemcitabine (1000 mg/m as a 30-min infusion) plus erlotinib (150 mg/day, arm B). In case of treatment failure, patients were crossed over to a second-line treatment with the comparator cytostatic drug without erlotinib. The primary study endpoint was the time to treatment failure of second-line therapy (TTF2). This interim analysis of toxicity contains safety data from the first 127 randomized patients. During first-line therapy, patients received a median number of three treatment cycles (range 0-13) in both the arms. Regarding chemotherapy, a treatment delay was observed in 12% of the cycles in arm A and in 22% of the cycles in arm B. Dose reductions of the cytostatic drug were performed in 18 and 27% of treatment cycles, respectively. Erlotinib dose reductions were performed in 6 and 11% of all cycles. Grade 3/4 hematological toxicity was <10% in both the arms; major grade 3/4 toxicities in arms A and B were diarrhea (9 vs. 7%), skin rash (4 vs. 12%), and hand-foot syndrome (7 vs. 0%). No treatment-related death was observed. In conclusion, this interim safety analysis suggests that treatment with erlotinib 150 mg/day is feasible in combination with capecitabine or gemcitabine.

Impact of the Absolute Difference in Diastolic Blood Pressure Between Arms in Patients With Coronary Artery Disease

PubMed Central

Hitaka, Yuka; Miura, Shin-ichiro; Koyoshi, Rie; Shiga, Yuhei; Miyase, Yuiko; Norimatsu, Kenji; Nakamura, Ayumi; Adachi, Sen; Kuwano, Takashi; Sugihara, Makoto; Ike, Amane; Nishikawa, Hiroaki; Saku, Keijiro

2015-01-01

Background We investigated the relationship between the severity and presence of coronary artery disease (CAD) and a difference in systolic and diastolic blood pressure (SBP and DBP) between arms or between lower limbs. Methods We enrolled 277 patients who underwent coronary angiography. We calculated the absolute (|right BP (rt. BP) - left BP (lt. BP)|) and relative (rt. BP - lt. BP) differences in SBP or DBP between arms or between lower limbs, and assessed the severity of CAD in terms of the Gensini score. Results The absolute difference in DBP between arms in the CAD group was significantly lower than that in the non-CAD group, whereas the absolute difference in DBP between lower limbs in the CAD group was significantly higher. There were no differences in the absolute or relative difference in SBP between arms or lower limbs between the groups. The absolute difference in DBP between arms decreased as the Gensini score increased. In a logistic regression analysis, the presence of CAD was independently associated with the absolute difference in DBP between arms, in addition to male, family history, dyslipidemia, diabetes mellitus and hypertension. Conclusion The absolute difference in DBP between arms in addition to traditional factors may be a critical risk factor for the presence of CAD. PMID:26491500

Integrative rehabilitation of elderly stroke survivors: The design and evaluation of the BrightArm™

PubMed Central

Rabin, Bryan A.; Burdea, Grigore C.; Roll, Doru T.; Hundal, Jasdeep S.; Damiani, Frank; Pollack, Simcha

2011-01-01

Purpose To describe the development of the BrightArm upper extremity rehabilitation system, and to determine its clinical feasibility with older hemiplegic patients. Method The BrightArm adjusted arm gravity loading through table tilting. Patients wore an arm support that sensed grasp strength and communicated wirelessly with a personal computer. Games were written to improve cognitive, psychosocial and the upper extremity motor function and adapted automatically to each patient. The system underwent feasibility trials spanning 6 weeks. Participants were evaluated pre-therapy, post-therapy, and at 6 weeks follow-up using standardized clinical measures. Computerized measures of supported arm reach and game performance were stored on a remote server. Results Five participants had clinically significant improvements in their active range of shoulder movement, shoulder strength, grasp strength, and their ability to focus. Several participants demonstrated substantially higher arm function (measured with the Fugl-Meyer test) and two were less-depressed (measured with the Becks Depression Inventory, Second Edition). The BrightArm technology was well-accepted by the participants, who gave it an overall subjective rating of 4.1 on a 5 point Likert scale. Conclusions Given these preliminary findings, it will be beneficial to evaluate the BrightArm through controlled clinical trials and to investigate its application to other clinical populations. PMID:22107353

The relation between magnetic and material arms in models for spiral galaxies

NASA Astrophysics Data System (ADS)

Moss, D.; Beck, R.; Sokoloff, D.; Stepanov, R.; Krause, M.; Arshakian, T. G.

2013-08-01

Context. Observations of polarized radio emission show that large-scale (regular) magnetic fields in spiral galaxies are not fully axisymmetric, but generally stronger in interarm regions. In some nearby galaxies such as NGC 6946 they are organized in narrow magnetic arms situated between the material spiral arms. Aims: The phenomenon of magnetic arms and their relation to the optical spiral arms (the material arms) calls for an explanation in the framework of galactic dynamo theory. Several possibilities have been suggested but are not completely satisfactory; here we attempt a consistent investigation. Methods: We use a 2D mean-field dynamo model in the no-z approximation and add injections of small-scale magnetic field, taken to result from supernova explosions, to represent the effects of dynamo action on smaller scales. This injection of small scale field is situated along the spiral arms, where star-formation mostly occurs. Results: A straightforward explanation of magnetic arms as a result of modulation of the dynamo mechanism by material arms struggles to produce pronounced magnetic arms, at least with realistic parameters, without introducing new effects such as a time lag between Coriolis force and α-effect. In contrast, by taking into account explicitly the small-scale magnetic field that is injected into the arms by the action of the star forming regions that are concentrated there, we can obtain dynamo models with magnetic structures of various forms that can be compared with magnetic arms. These are rather variable entities and their shape changes significantly on timescales of a few 100 Myr. Properties of magnetic arms can be controlled by changing the model parameters. In particular, a lower injection rate of small-scale field makes the magnetic configuration smoother and eliminates distinct magnetic arms. Conclusions: We conclude that magnetic arms can be considered as coherent magnetic structures generated by large-scale dynamo action, and associated with spatially modulated small-scale magnetic fluctuations, caused by enhanced star formation rates within the material arms.

Effects of Task-oriented Approach on Affected Arm Function in Children with Spastic Hemiplegia Due to Cerebral Palsy.

PubMed

Song, Chiang-Soon

2014-06-01

[Purpose] The purpose of the present study was to examine the effects of task-oriented approach on motor function of the affected arm in children with spastic hemiplegia due to cerebral palsy. [Subjects] Twelve children were recruited by convenience sampling from 2 local rehabilitation centers. The present study utilized a one-group pretest-posttest design. All of children received task-oriented training for 6 weeks (40 min/day, 5 days/week) and also underwent regular occupational therapy. Three clinical tests, Box and Block Test (BBT), Manual Ability Measure (MAM-16), and Wee Functional Independence Measure (WeeFIM) were performed 1 day before and after training to evaluate the effects of the training. [Results] Compared with the pretest scores, there was a significant increase in the BBT, MAM-16, and WeeFIM scores of the children after the 6-week practice period. [Conclusion] The results of this study suggest that a task-oriented approach to treatment of the affected arm improves functional activities, such as manual dexterity and fine motor performance, as well as basic daily activities of patients with spastic hemiplegia due to cerebral palsy.

Financial Incentives and Physician Commitment to Guideline-Recommended Hypertension Management: A Mixed Methods Approach

PubMed Central

Hysong, Sylvia J.; Simpson, Kate; Pietz, Kenneth; SoRelle, Richard; Broussard, Kristen; Petersen, Laura A.

2014-01-01

Objective To examine the impact of financial incentives on physician goal commitment to guideline-recommended hypertension care. Study design Clinic-level cluster-randomized controlled trial with four arms: control, individual-, group-, or combined incentives. Intervention arm participants received performance-based incentives every four months for five periods. All participants received guideline education at baseline and audit and feedback every four months. Methods 83 full-time primary care physicians at 12 VA Medical Centers completed web-based survey responses to Hollenbeck’s goal commitment scale every four months and telephone interviews at months 8 and 16. Results Physician goal commitment did not vary over time or across arms. Participants reported patient non-adherence and consistent follow-up as perceived barriers and facilitators to successful hypertension care, suggesting providers may perceive hypertension management as more of a patient responsibility (external locus of control). Conclusions Financial incentives may constitute an insufficiently strong intervention to influence goal commitment when providers attribute performance to external forces beyond their control. PMID:23145846

Lipoprotein Changes in HIV-Infected Antiretroviral-Naïve Individuals after Starting Antiretroviral Therapy: ACTG Study A5152s Stein: Lipoprotein Changes on Antiretroviral Therapy

PubMed Central

Stein, James H.; Komarow, Lauren; Cotter, Bruno R.; Currier, Judith S.; Dubé, Michael P.; Fichtenbaum, Carl J.; Gerschenson, Mariana; Mitchell, Carol K.C.; Murphy, Robert L.; Squires, Kathleen; Parker, Robert A.; Torriani, Francesca J.

2008-01-01

Background Dyslipidemia is a frequent complication of antiretroviral therapy (ART) for patients with human immunodeficiency virus infection (HIV). The effects of ART on lipoproteins are less well-understood, and have not been investigated in a prospective study where assignment to ART is randomized. Objective To evaluate the effects of three class-sparing ART regimens on lipids and lipoproteins. Methods This was a substudy of a prospective, multicenter study treatment-naïve HIV-infected individuals randomly assigned to receive a regimen of nucleoside reverse transcriptase inhibitors (NRTIs) + the non-nucleoside reverse transcriptase inhibitor efavirenz, NRTIs + the protease inhibitor lopinavir/ritonavir, or a NRTI-sparing regimen of efavirenz + lopinavir/ritonavir. Lipoproteins were measured by nuclear magnetic resonance spectroscopy. Results Among the 82 participants, total and small low-density lipoprotein concentrations increased (median, interquartile range) by 152 (-49 - +407, p<0.01) and 130 (-98 - +417, p<0.01) nmol/L, respectively, especially in the arms containing lopinavir/ritonavir (pKW<0.04). Very low-density lipoproteins also increased (p<0.01), with a larger increase in the arms that contained lopinavir/ritonavir (p=0.022). High-density lipoproteins increased by 6.0 nmol/L (2.8 - 10.4, p<0.01), but differences between arms were not significant (pKW=0.069). Changes were not related to changes in markers of insulin/glucose metabolism. Conclusions Total and small low-density lipoprotein concentrations increased, especially in the arms containing lopinavir/ritonavir, as did increases in total very low-density lipoproteins. Adverse changes were especially prominent in the arm with efavirenz + lopinavir/ritonavir. PMID:19956354

An explorative, cross-sectional study into abnormal muscular coupling during reach in chronic stroke patients

PubMed Central

2010-01-01

Background In many stroke patients arm function is limited, which can be related to an abnormal coupling between shoulder and elbow joints. The extent to which this can be translated to activities of daily life (ADL), in terms of muscle activation during ADL-like movements, is rather unknown. Therefore, the present study examined the occurrence of abnormal coupling on functional, ADL-like reaching movements of chronic stroke patients by comparison with healthy persons. Methods Upward multi-joint reaching movements (20 repetitions at a self-selected speed to resemble ADL) were compared in two conditions: once facilitated by arm weight compensation and once resisted to provoke a potential abnormal coupling. Changes in movement performance (joint angles) and muscle activation (amplitude of activity and co-activation) between conditions were compared between healthy persons and stroke patients using a repeated measures ANOVA. Results The present study showed slight changes in joint excursion and muscle activation of stroke patients due to shoulder elevation resistance during functional reach. Remarkably, in healthy persons similar changes were observed. Even the results of a sub-group of the more impaired stroke patients did not point to an abnormal coupling between shoulder elevation and elbow flexion during functional reach. Conclusions The present findings suggest that in mildly and moderately affected chronic stroke patients ADL-like arm movements are not substantially affected by abnormal synergistic coupling. In this case, it is implied that other major contributors to limitations in functional use of the arm should be identified and targeted individually in rehabilitation, to improve use of the arm in activities of daily living. PMID:20233402

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

A randomized phase II study of the MEK1/MEK2 inhibitor trametinib (GSK1120212) compared with docetaxel in KRAS-mutant advanced non-small-cell lung cancer (NSCLC)†

PubMed Central

Blumenschein, G. R.; Smit, E. F.; Planchard, D.; Kim, D.-W.; Cadranel, J.; De Pas, T.; Dunphy, F.; Udud, K.; Ahn, M.-J.; Hanna, N. H.; Kim, J.-H.; Mazieres, J.; Kim, S.-W.; Baas, P.; Rappold, E.; Redhu, S.; Puski, A.; Wu, F. S.; Jänne, P. A.

2015-01-01

Background KRAS mutations are detected in 25% of non-small-cell lung cancer (NSCLC) and no targeted therapies are approved for this subset population. Trametinib, a selective allosteric inhibitor of MEK1/MEK2, demonstrated preclinical and clinical activity in KRAS-mutant NSCLC. We report a phase II trial comparing trametinib with docetaxel in patients with advanced KRAS-mutant NSCLC. Patients and methods Eligible patients with histologically confirmed KRAS-mutant NSCLC previously treated with one prior platinum-based chemotherapy were randomly assigned in a ratio of 2 : 1 to trametinib (2 mg orally once daily) or docetaxel (75 mg/m2 i.v. every 3 weeks). Crossover to the other arm after disease progression was allowed. Primary end point was progression-free survival (PFS). The study was prematurely terminated after the interim analysis of 92 PFS events, which showed the comparison of trametinib versus docetaxel for PFS crossed the futility boundary. Results One hundred and twenty-nine patients with KRAS-mutant NSCLC were randomized; of which, 86 patients received trametinib and 43 received docetaxel. Median PFS was 12 weeks in the trametinib arm and 11 weeks in the docetaxel arm (hazard ratio [HR] 1.14; 95% CI 0.75–1.75; P = 0.5197). Median overall survival, while the data are immature, was 8 months in the trametinib arm and was not reached in the docetaxel arm (HR 0.97; 95% CI 0.52–1.83; P = 0.934). There were 10 (12%) partial responses (PRs) in the trametinib arm and 5 (12%) PRs in the docetaxel arm (P = 1.0000). The most frequent adverse events (AEs) in ≥20% of trametinib patients were rash, diarrhea, nausea, vomiting, and fatigue. The most frequent grade 3 treatment-related AEs in the trametinib arm were hypertension, rash, diarrhea, and asthenia. Conclusion Trametinib showed similar PFS and a response rate as docetaxel in patients with previously treated KRAS-mutant-positive NSCLC. Clinicaltrials.gov registration number NCT01362296. PMID:25722381

Armed and Dangerous? UAVs and U.S. Security

DTIC Science & Technology

2014-01-01

MEMS] as inertial navigation units [INUs]. This technology is widely used in commercial products, such as toy helicopters and Wii controllers. The...aircraft? In conclusion, both the MTCR and Wassenaar Arrange- ment provide the United States with the flexibility and controls to be able to balance its...security and nonproliferation goals with respect to armed UAVs. Perhaps more problematic is whether the government interagency can strike a balance

Morbidity after conventional dissection of axillary lymph nodes in breast cancer patients

PubMed Central

2014-01-01

Background Conventional axillary lymph node dissection (ALND) has recently become less radical. The treatment morbidity effects of reduced ALND aggressiveness are unknown. This article investigates the prevalence of the main complications of ALND: lymphedema, range-of-motion restriction, and arm paresthesia and pain. Methods This cross-sectional study included 200 women with invasive breast cancer who underwent breast-conserving surgery (82.5%, n = 165) or mastectomy (17.5%, n = 35) with ALND from 2007 to 2011. Arm perimetry was used to assess lymphedema, defined as a difference >2 cm in the upper arm circumference between the nonsurgical and surgical arms. Range-of-motion restriction was assessed by evaluating the degree of arm abduction. Paresthesia was measured in the inner and proximal arm regions. Arm pain was assessed by directly questioning the patients and defined as either present or absent. Results The average (±SD) time between ALND and morbidity evaluation was 35 ± 18 months (range, 7-60 months). The average dissected lymph node number per patient was 14 ± 4 (range, 6-30 lymph nodes). Only 3.5% (n = 7) of the patients presented with lymphedema. Single-incision approaches to breast tumor and ALND (P = 0.04) and the presence of a postoperative seroma (P = 0.02) were associated with lymphedema in univariate analysis. Paresthesia was the most frequent side effect observed (53% of patients, n = 106). This complication was associated with increased age (P < 0.0001) and a larger dissected lymph node number (P = 0.01) in univariate and multivariate analysis. Additionally, 24% (n = 48) of patients had noticeable limited arm abduction. Among the patients, 27.5% (n = 55) experienced sporadic arm pain corresponding to the surgically treated armpit. In multivariate analysis, the pain risk was 1.9-fold higher in patients who underwent ALND corresponding to their dominant arm (95% CI, 1.0-3.7, P = 0.04). Conclusion Conventional ALND in breast cancer patients can result in unwanted complications. However, the current lymphedema prevalence is lower than that of the other analyzed side effects. PMID:24670000

Internal porosity of cast titanium removable partial dentures: influence of sprue direction and diameter on porosity in simplified circumferential clasps.

PubMed

Baltag, Ioana; Watanabe, Kouichi; Miyakawa, Osamu

2005-06-01

The behavior of molten titanium in molds of complicated shape is still insufficiently understood; consequently, definite spruing criteria are not yet available for titanium RPD frameworks. This study investigated the influence of sprue design on porosity in pressure-cast titanium circumferential clasps. The patterns of 90 circumferential clasps were sprued with three directions (0, 30 and 60 degrees , as measured between the sprue and the symmetry plane of the clasp assembly) and three sprue diameters (1.5, 2.0 and 2.5mm). CPTi was cast in a one-chamber pressure casting machine. Pore number and size were assessed on radiographs of the castings. Statistical analysis was done by two-way analysis of variance (ANOVA), followed by Fisher's PLSD post hoc test. The porosity in lingual arms increased significantly with increase of sprue diameter and sprue angle, while the porosity in minor connectors had an inversely proportional distribution. Very low porosity, uninfluenced by sprue design, was found in buccal arms. In conclusion, internal porosity in titanium circumferential clasp arms can be minimized through sprue design: the 0 degrees sprue direction produced the least porosity, while for the 30 and 60 degrees directions, 1.5mm diameter sprues produced lower porosity than 2.0 and 2.5mm diameter sprues. In this study, the lowest porosity in titanium circumferential clasp arms was obtained with sprues attached perpendicularly to the minor connectors, regardless of sprue diameter. Conventional sprue directions produced significantly higher porosity in clasp lingual arms, the amount of porosity increasing with sprue diameter.

Knowing the ABCs: A Comparative Effectiveness Study of Two Methods of Diabetes Education

PubMed Central

Naik, Aanand D.; Teal, Cayla R.; Rodriguez, Elisa; Haidet, Paul

2011-01-01

Objective To test an active-learning, empowerment approach to teaching patients about the “diabetes ABCs” (hemoglobin A1C, systolic blood pressure, and low density lipoprotein cholesterol). Methods 84 (97%) diabetic patients who participated in a randomized effectiveness trial of two clinic-based group educational methods and completed a post-intervention assessment. The empowerment arm participated in a group session that incorporated two educational innovations (a conceptual metaphor to foster understanding, and team-based learning methods to foster active learning). The traditional diabetes education arm received a didactic group session focused on self-management and educational materials about the diabetes ABCs. Participants in both arms received individual review of their current ABC values. Results A questionnaire evaluated knowledge, understanding, and recall of the diabetes ABCs was administered three months after enrollment in the study. At three months, participants in the empowerment group demonstrated greater understanding of the diabetes ABCs (P<.0001), greater knowledge of their own values (P<.0001), and greater knowledge of guideline-derived target goals for the ABCs compared with participants in the traditional arm (P<.0001). Conclusion An active-learning, empowerment-based approach applied to diabetes education can lead to greater understanding and knowledge retention. Practice Implications An empowerment approach to education can facilitate informed, activated patients and increase performance of self-management behaviors. PMID:21300516

Upper limb joint kinetics of three sitting pivot wheelchair transfer techniques in individuals with spinal cord injury

PubMed Central

Kankipati, Padmaja; Boninger, Michael L.; Gagnon, Dany; Cooper, Rory A.; Koontz, Alicia M.

2015-01-01

Study design Repeated measures design. Objective This study compared the upper extremity (UE) joint kinetics between three transfer techniques. Setting Research laboratory. Methods Twenty individuals with spinal cord injury performed three transfer techniques from their wheelchair to a level tub bench. Two of the techniques involved a head–hips method with leading hand position close (HH-I) and far (HH-A) from the body, and the third technique with the trunk upright (TU) and hand far from body. Motion analysis equipment recorded upper body movements and force sensors recorded their hand and feet reaction forces during the transfers. Results Several significant differences were found between HH-A and HH-I and TU and HH-I transfers indicating that hand placement was a key factor influencing the UE joint kinetics. Peak resultant hand, elbow, and shoulder joint forces were significantly higher for the HH-A and TU techniques at the trailing arm (P < 0.036) and lower at the leading arm (P < 0.021), compared to the HH-I technique. Conclusion Always trailing with the same arm if using HH-A or TU could predispose that arm to overuse related pain and injuries. Technique training should focus on initial hand placement close to the body followed by the amount of trunk flexion needed to facilitate movement. PMID:25130053

The Effect of a Structural Intervention for Syphilis Control Among 3597 Female Sex Workers: A Demonstration Study in South China

PubMed Central

Wang, Baoxi; Wang, Qian-Qiu; Yin, Yue-Ping; Liang, Guo-Jun; Jiang, Ning; Gong, Xiang-Dong; Yang, Bin; Zhou, Yue-Jiao; Liu, Qiao; Huan, Xi-Ping; Yang, Li-Gang; Tan, Guang-Jie; Pei, Dong-Nu; Tucker, Joseph D.; Chen, Xiang-Sheng

2012-01-01

Background. Syphilis has made a rapid resurgence in China, especially among high-risk groups including female sex workers (FSWs). Methods. Two cities in each of 3 provinces in South China were chosen and allocated to intervention or control arms. The intervention consisted of enhancing community-based syphilis screening outreach intervention with comprehensive sexually transmitted infection services at designated clinics while the control maintained routine intervention activities. Generalized linear modeling was used to examine effect of the intervention on incident syphilis infection. Results. A total of 8275 women were eligible, and 3597 women enrolled (n = 2011 in control arm, n = 1586 in intervention arm) in the study. The median follow-up duration was 375 days (interquartile range, 267–475). Syphilis incidence density in the intervention group was reduced by 70% (95% confidence interval, 53%–81%) compared with the incidence in the control arm. The syphilis prevention intervention benefits were robust among FSWs at low-tier venues, individuals with less than high school education, migrants, and women who did not report condom use during the last episode of sex. Conclusions. Integrated sexually transmitted infection and human immunodeficiency virus prevention strategies substantially reduce syphilis incidence among FSWs, especially among those at low-tier venues. This intervention suggests the need for scaling up comprehensive FSW programs in China. PMID:22807520

Prospective Randomized Phase 2 Trial of Intensity Modulated Radiation Therapy With or Without Oncolytic Adenovirus-Mediated Cytotoxic Gene Therapy in Intermediate-Risk Prostate Cancer

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

Freytag, Svend O., E-mail: sfreyta1@hfhs.org; Stricker, Hans; Lu, Mei

Purpose: To assess the safety and efficacy of combining oncolytic adenovirus-mediated cytotoxic gene therapy (OAMCGT) with intensity modulated radiation therapy (IMRT) in intermediate-risk prostate cancer. Methods and Materials: Forty-four men with intermediate-risk prostate cancer were randomly assigned to receive either OAMCGT plus IMRT (arm 1; n=21) or IMRT only (arm 2; n=23). The primary phase 2 endpoint was acute (≤90 days) toxicity. Secondary endpoints included quality of life (QOL), prostate biopsy (12-core) positivity at 2 years, freedom from biochemical/clinical failure (FFF), freedom from metastases, and survival. Results: Men in arm 1 exhibited a greater incidence of low-grade influenza-like symptoms, transaminitis,more » neutropenia, and thrombocytopenia than men in arm 2. There were no significant differences in gastrointestinal or genitourinary events or QOL between the 2 arms. Two-year prostate biopsies were obtained from 37 men (84%). Thirty-three percent of men in arm 1 were biopsy-positive versus 58% in arm 2, representing a 42% relative reduction in biopsy positivity in the investigational arm (P=.13). There was a 60% relative reduction in biopsy positivity in the investigational arm in men with <50% positive biopsy cores at baseline (P=.07). To date, 1 patient in each arm exhibited biochemical failure (arm 1, 4.8%; arm 2, 4.3%). No patient developed hormone-refractory or metastatic disease, and none has died from prostate cancer. Conclusions: Combining OAMCGT with IMRT does not exacerbate the most common side effects of prostate radiation therapy and suggests a clinically meaningful reduction in positive biopsy results at 2 years in men with intermediate-risk prostate cancer.« less

Tinidazole versus Metronidazole for the Treatment of Bacterial Vaginosis

PubMed Central

SCHWEBKE, Jane R.; DESMOND, Renee A.

2010-01-01

Objective To compare the efficacy of two different doses of tinidazole with metronidazole for treatment of bacterial vaginosis and compare side effects of the drugs. Study design Women were randomized to metronidazole 500 mg BID, tinidazole 500 mg BID, or tinidazole 1 gm BID all for 7 days. Follow-up visits were conducted at day 14 and day 28. Results 593 women were enrolled. There were no significant differences between the treatment arms. Overall cure rates were 76.8% at 14 days and 64.5% at one month. Women who admitted to engaging in sexual intercourse during the study were significantly more likely to have BV at follow-up. There were no significant differences in adverse events across treatment arms. Conclusions There were no differences in cure rates between metronidazole and either of the tinidazole dosing regimens studied. In addition, there were no important differences in the side effect profiles of metronidazole and tinidazole. PMID:21167471

Enhancing Informed Choice to Undergo Health Screening: A Systematic Review

PubMed Central

Biesecker, Barbara Bowles; Schwartz, Marc D.; Marteau, Theresa M.

2012-01-01

Objective To assess the effectiveness of health screening interventions aimed at enhancing informed choice. Methods Studies were selected if (1) they were randomized controlled trials conducted between January 1, 2000, and March 30, 2010, (2) participants in one arm underwent a prescreening intervention aimed at improving informed choice, and (3) informed choice was the primary outcome. Results Eight studies that met the inclusion criteria involved screening for prostate, colorectal and breast cancer, and diabetes. Five of the 8 prescreening interventions led to greater informed choice. Conclusions With researchers mindful of the limited number of studies, findings were encouraging, but conclusions regarding the most effective ways of facilitating informed choice for screening are at best tentative. PMID:23985182

Accelerating clinical development of HIV vaccine strategies: methodological challenges and considerations in constructing an optimised multi-arm phase I/II trial design.

PubMed

Richert, Laura; Doussau, Adélaïde; Lelièvre, Jean-Daniel; Arnold, Vincent; Rieux, Véronique; Bouakane, Amel; Lévy, Yves; Chêne, Geneviève; Thiébaut, Rodolphe

2014-02-26

Many candidate vaccine strategies against human immunodeficiency virus (HIV) infection are under study, but their clinical development is lengthy and iterative. To accelerate HIV vaccine development optimised trial designs are needed. We propose a randomised multi-arm phase I/II design for early stage development of several vaccine strategies, aiming at rapidly discarding those that are unsafe or non-immunogenic. We explored early stage designs to evaluate both the safety and the immunogenicity of four heterologous prime-boost HIV vaccine strategies in parallel. One of the vaccines used as a prime and boost in the different strategies (vaccine 1) has yet to be tested in humans, thus requiring a phase I safety evaluation. However, its toxicity risk is considered minimal based on data from similar vaccines. We newly adapted a randomised phase II trial by integrating an early safety decision rule, emulating that of a phase I study. We evaluated the operating characteristics of the proposed design in simulation studies with either a fixed-sample frequentist or a continuous Bayesian safety decision rule and projected timelines for the trial. We propose a randomised four-arm phase I/II design with two independent binary endpoints for safety and immunogenicity. Immunogenicity evaluation at trial end is based on a single-stage Fleming design per arm, comparing the observed proportion of responders in an immunogenicity screening assay to an unacceptably low proportion, without direct comparisons between arms. Randomisation limits heterogeneity in volunteer characteristics between arms. To avoid exposure of additional participants to an unsafe vaccine during the vaccine boost phase, an early safety decision rule is imposed on the arm starting with vaccine 1 injections. In simulations of the design with either decision rule, the risks of erroneous conclusions were controlled <15%. Flexibility in trial conduct is greater with the continuous Bayesian rule. A 12-month gain in timelines is expected by this optimised design. Other existing designs such as bivariate or seamless phase I/II designs did not offer a clear-cut alternative. By combining phase I and phase II evaluations in a multi-arm trial, the proposed optimised design allows for accelerating early stage clinical development of HIV vaccine strategies.

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

Ambulatory Treatment of Fast Breathing in Young Infants Aged <60 Days: A Double-Blind, Randomized, Placebo-Controlled Equivalence Trial in Low-Income Settlements of Karachi

PubMed Central

Muhammad, Amber A.; Shafiq, Yasir; Shah, Saima; Kumar, Naresh; Ahmed, Imran; Azam, Iqbal; Pasha, Omrana; Zaidi, Anita K. M.

2017-01-01

Abstract Background. Integrated Management of Childhood Illness recommends that young infants with isolated fast breathing be referred to a hospital for antibiotic treatment, which is often impractical in resource-limited settings. Additionally, antibiotics may be unnecessary for physiologic tachypnea in otherwise well newborns. We tested the hypothesis that ambulatory treatment with oral amoxicillin for 7 days was equivalent (similarity margin of 3%) to placebo in young infants with isolated fast breathing in primary care settings where hospital referral is often unfeasible. Methods. This randomized equivalence trial was conducted in 4 primary health centers of Karachi, Pakistan. Infants presenting with isolated fast breathing and oxygen saturation ≥90% were randomly assigned to receive either oral amoxicillin or placebo twice daily for 7 days. Enrolled infants were followed on days 1–8, 11, and 14. The primary outcome was treatment failure by day 8, analyzed per protocol. The trial was stopped by the data safety monitoring board due to higher treatment failure rate and the occurrence of 2 deaths in the placebo arm in an interim analysis. Results. Four hundred twenty-three infants fulfilled per protocol criteria in the amoxicillin arm and 426 in the placebo arm. Twelve infants (2.8%) had treatment failure in the amoxicillin arm and 25 (5.9%) in the placebo arm (risk difference, 3.1; P value .04). Two infants in the placebo arm died, whereas no deaths occurred in the amoxicillin arm. Other adverse outcomes, as well as the proportions of relapse, were evenly distributed across both study arms. Conclusions. This trial failed to show equivalence of placebo to amoxicillin in the management of isolated fast breathing without hypoxemia or other clinical signs of illness in term young infants. Clinical Trials Registration. NCT01533818. PMID:27941119

Prevalence of and factors influencing posttraumatic stress disorder among mothers of children under five in Kabul, Afghanistan, after decades of armed conflicts

PubMed Central

Seino, Kaoruko; Takano, Takehito; Mashal, Taufiq; Hemat, Shafiqullah; Nakamura, Keiko

2008-01-01

Background In the period following wars and other forms of armed conflict, health and quality of life of mothers is a major concern as they have the closest contact with children. The present study was performed to examine the impact of exposure to events related to armed conflicts on post traumatic stress disorder (PTSD) among women raising children, and to identify factors that alleviate the negative consequences of exposure to traumatic events. Methods A structured interview survey was conducted in Kabul Province, Afghanistan, in 2006. The subjects were the mothers of children less than 5 years old randomly selected from 1400 households in Kabul Province, Afghanistan. Symptoms of PTSD were assessed according to the criteria of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). Exposure to traumatic events related to armed conflict, experience of hardship with regard to basic needs, resources that the subjects seek for mental health support, and socioeconomic variables were evaluated. Logistic regression analysis was performed to determine the association between PTSD symptoms and predictor variables. Results The prevalence rate of PTSD among 1172 women participated in this study was 29.8%. The most prevalent symptom was arousal (74.8%), followed by re-experiencing (54.9%) and avoidance (33.7%). The prevalence rate of PTSD symptoms among subjects who reported having experienced at least one event related to armed conflict (52.7%) was significantly higher than that among those who reported no such experiences (9.6%). Experience of food shortage was independently associated with PTSD. Seeking support for mental health was related to lower prevalence of PTSD symptoms among those who reported no direct experience of events related to armed conflict. However, no such relationship was observed with PTSD symptoms among those who reported having direct experience of events related to armed conflict. Conclusion Direct exposure to traumatic events was significantly associated with PTSD symptoms among women raising children. For those who had experienced armed conflict-related events, food security mitigated the occurrence of PTSD symptoms; however, support seeking behavior did not show a significant mitigating influence on PTSD. Means to alleviate the negative influence of exposure to armed conflicts on the quality of life of women should be developed from the viewpoint of quality of mental health support and avoidance of material hardship. PMID:18433474

TRUST-tPA trial: Telemedicine for remote collaboration with urgentists for stroke-tPA treatment.

PubMed

Mazighi, Mikael; Meseguer, Elena; Labreuche, Julien; Miroux, Patrick; Le Gall, Catherine; Roy, Patricia; Tubach, Florence; Amarenco, Pierre

2017-01-01

Background Previous observational studies have shown that telemedicine is feasible and safe to deliver intravenous (IV) recombinant tissue plasminogen activator (rt-PA). However, implementation of telemedicine may be challenging. To illustrate this fact, we report a study showing that telemedicine failed to improve clinical outcome and analyze the reasons for this shortcoming. Methods We established a tele-stroke network of 10 emergency rooms (ERs) of community hospitals connected to a stroke center to perform a randomized, open-label clinical trial with blinded outcome evaluation. Eligible patients were randomly assigned to either a usual care arm (i.e. immediate transfer to the stroke center and administration of IV rt-PA if indication was confirmed upon stroke arrival) or tele-thrombolysis arm (i.e. immediate administration of IV rt-PA in ER and transfer to the stroke center). The primary efficacy outcome was an excellent outcome (modified Rankin scale (mRS) 0-1 at 90 days). Secondary endpoints included favorable outcome (90-day mRS 0-2) and early neurological improvement (NIHSS score 0-1 at 24 hours or a decrease of ≥ 4 points within 24 hours). Safety outcomes included symptomatic intracerebral hemorrhage (ICH) per ECASS II definition, any ICH and all-cause mortality. Results During an accrual time of 48 months, because of a slow enrollment rate, only 49 of 270 patients initially planned for inclusion were randomized into usual care ( n = 23) and tele-thrombolysis ( n = 26). Despite random assignment, patients allocated to tele-thrombolysis were older and had more severe stroke than patients allocated to usual care. The median duration of video-conference was 23 minutes in the usual care arm and 73 minutes in the tele-thrombolysis arm. Eighty-four percent of patients in the tele-thrombolysis arm were treated by IV rt-PA in comparison to 18% in the usual care arm. In univariate analysis but not after adjustment for age and baseline NIHSS, patients allocated in the usual care arm had a higher rate of excellent or favorable outcome. There were no differences in safety outcomes, with only one symptomatic ICH occurring in the tele-thrombolysis arm. Conclusions Stroke patients included in the telemedicine arm of the TRUST-tPA trial increased their rt-PA eligibility five-fold. However, the efficacy and safety remains to be determined (ClinicalTrials.org, NCT00279149).

Effect of sexual intercourse on the absorption of levonorgestrel after vaginal administration of 0.75 mg in Carraguard® gel: a randomized, cross-over, pharmacokinetic study☆

PubMed Central

Brache, Vivian; Croxatto, Horacio; Kumar, Narender; Sitruk-Ware, Regine; Cochón, Leila; Schiappacasse, Veronica; Sivin, Irving; Muñoz, Carla; Maguire, Robin; Faundes, Anibal

2010-01-01

Background The Population Council studied a pre-coital contraceptive microbicide vaginal product containing levonorgestrel (LNG) as active component and Carraguard® gel as a vehicle (Carra/LNG gel) for couples who engage in occasional unplanned intercourse. The objective of this study was to evaluate the effect of sexual intercourse after vaginal application of Carra/LNG gel on serum levels of LNG in women and to assess LNG absorption by the male partner. Study Design This was a randomized, cross-over, pharmacokinetic study including an abstinence arm and an arm in which couples engaged in sexual intercourse between 2 and 4 h after gel application. In each study arm, each woman received a single application of Carra/LNG gel (0.75 mg in 4 mL gel) followed by serial blood samples taken at 0, 1, 2, 4, 8, 24 and 48 h after gel application for LNG measurements. In the intercourse arm, LNG was measured in blood samples taken from the male partner before intercourse and at 4, 8 and 24 h after gel application in the female partner. Results Time concentration curves for serum LNG levels showed a mean Cmax of 7.8±5.5 and 8.3±5.7 nmol/L, a mean Tmax of 6.2±5.9 and 7.5±5.7, and comparable area under the curve for the intercourse and abstinence arm, respectively. Pharmacokinetic parameters presented large variability between subjects, but excellent reproducibility within each subject. LNG was undetectable in 10 out of 12 male partners. Conclusion Sexual intercourse does not appear to interfere with vaginal absorption of LNG after application of a Carra/LNG gel. A vaginal pre-coital contraceptive gel is feasible. PMID:19135574

Automatic C-arm pose estimation via 2D/3D hybrid registration of a radiographic fiducial

NASA Astrophysics Data System (ADS)

Moult, E.; Burdette, E. C.; Song, D. Y.; Abolmaesumi, P.; Fichtinger, G.; Fallavollita, P.

2011-03-01

Motivation: In prostate brachytherapy, real-time dosimetry would be ideal to allow for rapid evaluation of the implant quality intra-operatively. However, such a mechanism requires an imaging system that is both real-time and which provides, via multiple C-arm fluoroscopy images, clear information describing the three-dimensional position of the seeds deposited within the prostate. Thus, accurate tracking of the C-arm poses proves to be of critical importance to the process. Methodology: We compute the pose of the C-arm relative to a stationary radiographic fiducial of known geometry by employing a hybrid registration framework. Firstly, by means of an ellipse segmentation algorithm and a 2D/3D feature based registration, we exploit known FTRAC geometry to recover an initial estimate of the C-arm pose. Using this estimate, we then initialize the intensity-based registration which serves to recover a refined and accurate estimation of the C-arm pose. Results: Ground-truth pose was established for each C-arm image through a published and clinically tested segmentation-based method. Using 169 clinical C-arm images and a +/-10° and +/-10 mm random perturbation of the ground-truth pose, the average rotation and translation errors were 0.68° (std = 0.06°) and 0.64 mm (std = 0.24 mm). Conclusion: Fully automated C-arm pose estimation using a 2D/3D hybrid registration scheme was found to be clinically robust based on human patient data.

Initial Design Study of Existing Flight Control System of RPH and Feasibility Study of Implementing HHC on the SH-60B

DTIC Science & Technology

1990-09-01

35 C. HYDRAULICS ............................................. 39 iv VII. CONCLUSIONS AND RECOMMENDATIONS...requirement can be calculated. The maximum RMS torque required was obtained using the following equation: TMAX = t MAr T ZSm (15) 14 IV. RESULTS A...with the addition to added weight on the pitch arm/link 35 assemblies all related components would have to be strengthened to take the centrifugal loads

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

Douillard, Jean-Yves; Rosell, Rafael; De Lena, Mario

Purpose: To study the impact of postoperative radiation therapy (PORT) on survival in the Adjuvant Navelbine International Trialist Association (ANITA) randomized study of adjuvant chemotherapy. Methods and Materials: ANITA is a randomized trial of adjuvant cisplatin and vinorelbine chemotherapy vs. observation in completely resected non-small-cell lung carcinoma (NSCLC) Stages IB to IIIA. Use of PORT was recommended for pN+ disease but was not randomized or mandatory. Each center decided whether to use PORT before initiation of the study. We describe here the survival of patients with and without PORT within each treatment group of ANITA. No statistical comparison of survivalmore » was performed because this was an unplanned subgroup analysis. Results: Overall, 232 of 840 patients received PORT (33.3% in the observation arm and 21.6% in the chemotherapy arm). In univariate analysis, PORT had a deleterious effect on the overall population survival. Patients with pN1 disease had an improved survival from PORT in the observation arm (median survival [MS] 25.9 vs. 50.2 months), whereas PORT had a detrimental effect in the chemotherapy group (MS 93.6 months and 46.6 months). In contrast, survival was improved in patients with pN2 disease who received PORT, both in the chemotherapy (MS 23.8 vs. 47.4 months) and observation arm (median 12.7 vs. 22.7 months). Conclusion: This retrospective evaluation suggests a positive effect of PORT in pN2 disease and a negative effect on pN1 disease when patients received adjuvant chemotherapy. The results support further evaluation of PORT in prospectively randomized studies in completely resected pN2 NSCLC.« less

Phase II trial of temozolomide and sorafenib in advanced melanoma patients with or without brain metastases

PubMed Central

Amaravadi, Ravi K.; Schuchter, Lynn M.; McDermott, David F.; Kramer, Amy; Giles, Lydia; Gramlich, Kristi; Carberry, Mary; Troxel, Andrea B.; Letrero, Richard; Nathanson, Katherine L.; Atkins, Michael B.; O’Dwyer, Peter J.; Flaherty, Keith T.

2009-01-01

Purpose The combination of the oral alkylating agent temozolomide and the oral multi-kinase inhibitor sorafenib was evaluated in advanced melanoma patients. Patients and Methods Patients with metastatic melanoma (N=167) were treated on four arms. All patients received sorafenib at 400 mg orally twice daily without interruption. Patients without brain metastases or prior temozolomide were randomized between Arm A: extended dosing of temozolomide (EDT; 75 mg/m2 temozolomide daily for 6/8 weeks) and Arm B: standard dosing (SDT; 150 mg/m2 temozolomide daily for 5/28 days). Patients previously treated with temozolomide were enrolled on Arm C: EDT. Patients with brain metastases and no prior temozolomide were assigned to Arm D: SDT. The primary endpoint was 6-month progression-free survival (PFS) rate. Secondary endpoints included response rate, toxicity rates, and the rates of BRAF or NRAS mutations. Results The 6-month PFS rate for arms A, B, C, and D were 50%, 40%, 11%, and 23%. The median PFS for patients on arm A, B, C, and D was 5.9, 4.2, 2.2, and 3.5 months, respectively. No significant differences were observed between Arms A and B in 6-month PFS rate, median PFS, or response rates. Treatment was well tolerated in all arms. No significant differences in toxicity were observed between arms A and B except for more grade 3–4 lymphopenia in arm A. Conclusion Temozolomide plus sorafenib was well tolerated and demonstrated activity in melanoma patients without prior history of temozolomide. The activity of this combination regimen warrants further investigation. PMID:19996224

Sequential Versus Concurrent Trastuzumab in Adjuvant Chemotherapy for Breast Cancer

PubMed Central

Perez, Edith A.; Suman, Vera J.; Davidson, Nancy E.; Gralow, Julie R.; Kaufman, Peter A.; Visscher, Daniel W.; Chen, Beiyun; Ingle, James N.; Dakhil, Shaker R.; Zujewski, JoAnne; Moreno-Aspitia, Alvaro; Pisansky, Thomas M.; Jenkins, Robert B.

2011-01-01

Purpose NCCTG (North Central Cancer Treatment Group) N9831 is the only randomized phase III trial evaluating trastuzumab added sequentially or used concurrently with chemotherapy in resected stages I to III invasive human epidermal growth factor receptor 2–positive breast cancer. Patients and Methods Patients received doxorubicin and cyclophosphamide every 3 weeks for four cycles, followed by paclitaxel weekly for 12 weeks (arm A), paclitaxel plus sequential trastuzumab weekly for 52 weeks (arm B), or paclitaxel plus concurrent trastuzumab for 12 weeks followed by trastuzumab for 40 weeks (arm C). The primary end point was disease-free survival (DFS). Results Comparison of arm A (n = 1,087) and arm B (n = 1,097), with 6-year median follow-up and 390 events, revealed 5-year DFS rates of 71.8% and 80.1%, respectively. DFS was significantly increased with trastuzumab added sequentially to paclitaxel (log-rank P < .001; arm B/arm A hazard ratio [HR], 0.69; 95% CI, 0.57 to 0.85). Comparison of arm B (n = 954) and arm C (n = 949), with 6-year median follow-up and 313 events, revealed 5-year DFS rates of 80.1% and 84.4%, respectively. There was an increase in DFS with concurrent trastuzumab and paclitaxel relative to sequential administration (arm C/arm B HR, 0.77; 99.9% CI, 0.53 to 1.11), but the P value (.02) did not cross the prespecified O'Brien-Fleming boundary (.00116) for the interim analysis. Conclusion DFS was significantly improved with 52 weeks of trastuzumab added to adjuvant chemotherapy. On the basis of a positive risk-benefit ratio, we recommend that trastuzumab be incorporated into a concurrent regimen with taxane chemotherapy as an important standard-of-care treatment alternative to a sequential regimen. PMID:22042958

Detachment of secondary dendrite arm in a directionally solidified Sn-Ni peritectic alloy under deceleration growth condition

PubMed Central

Peng, Peng; Li, Xinzhong; Li, Jiangong; Su, Yanqing; Guo, Jingjie; Fu, Hengzhi

2016-01-01

In order to better understand the detachment mechanism of secondary dendrite arm during peritectic solidification, the detachment of secondary dendrite arm from the primary dendrite arms in directionally solidified Sn-36at.%Ni peritectic alloys is investigated at different deceleration rates. Extensive detachment of secondary dendrite arms from primary stem is observed below peritectic reaction temperature TP. And an analytical model is established to characterize the detachment process in terms of the secondary dendrite arm spacing λ2, the root radius of detached arms and the specific surface area (SV) of dendrites. It is found that the detachment mechanism is caused by not only curvature difference between the tips and roots of secondary branches, but also that between the thicker secondary branches and the thinner ones. Besides, this detachment process is significantly accelerated by the temperature gradient zone melting (TGZM) effect during peritectic solidification. It is demonstrated that the reaction constant (f) which is used to characterize the kinetics of peritectic reaction is crucial for the determination of the detachment process. The value of f not only changes with growth rate but also with solidification time at a given deceleration rate. In conclusion, these findings help the better understanding of the detachment mechanism. PMID:27270334

Predicting SF-6D utility scores from the Neck Disability Index and Numeric Rating Scales for Neck and Arm Pain

PubMed Central

Carreon, Leah Y.; Anderson, Paul A.; McDonough, Christine M.; Djurasovic, Mladen; Glassman, Steven D.

2010-01-01

Study Design Cross-sectional cohort Objective This study aims to provide an algorithm estimate SF-6D utilities using data from the NDI, neck pain and arm pain scores. Summary of Background Data Although cost-utility analysis is increasingly used to provide information about the relative value of alternative interventions, health state values or utilities are rarely available from clinical trial data. The Neck Disability Index (NDI) and numeric rating scales for neck and arm pain, are widely used disease-specific measures of symptoms, function and disability in patients with cervical degenerative disorders. The purpose of this study is to provide an algorithm to allow estimation of SF-6D utilities using data from the NDI, and numeric rating scales for neck and arm pain. Methods SF-36, NDI, neck and arm pain rating scale scores were prospectively collected pre-operatively, at 12 and 24 months post-operatively in 2080 patients undergoing cervical fusion for degenerative disorders. SF-6D utilities were computed and Spearman correlation coefficients were calculated for paired observations from multiple time points between NDI, neck and arm pain scores and SF-6D utility scores. SF-6D scores were estimated from the NDI, neck and arm pain scores using a linear regression model. Using a separate, independent dataset of 396 patients in which and NDI scores were available SF-6D was estimated for each subject and compared to their actual SF-6D. Results The mean age for those in the development sample, was 50.4 ± 11.0 years and 33% were male. In the validation sample the mean age was 53.1 ± 9.9 years and 35% were male. Correlations between the SF-6D and the NDI, neck and arm pain scores were statistically significant (p<0.0001) with correlation coefficients of 0.82, 0.62, and 0.50 respectively. The regression equation using NDI alone to predict SF-6D had an R2 of 0.66 and a root mean square error (RMSE) of 0.056. In the validation analysis, there was no statistically significant difference (p=0.961) between actual mean SF-6D (0.49 ± 0.08) and the estimated mean SF-6D score (0.49 ± 0.08) using the NDI regression model. Conclusion This regression-based algorithm may be a useful tool to predict SF-6D scores in studies of cervical degenerative disease that have collected NDI but not utility scores. PMID:20847713

Effectiveness of Functional Electrical Stimulation in Improving Clinical Outcomes in the Upper Arm following Stroke: A Systematic Review and Meta-Analysis

PubMed Central

Vafadar, Amir K.; Côté, Julie N.; Archambault, Philippe S.

2015-01-01

Background. Different therapeutic methods are being used to prevent or decrease long-term impairments of the upper arm in stroke patients. Functional electrical stimulation (FES) is one of these methods, which aims to stimulate the nerves of the weakened muscles so that the resulting muscle contractions resemble those of a functional task. Objectives. The objective of this study was to review the evidence for the effect of FES on (1) shoulder subluxation, (2) pain, and (3) upper arm motor function in stroke patients, when added to conventional therapy. Methods. From the 727 retrieved articles, 10 (9 RCTs, 1 quasi-RCT) were selected for final analysis and were rated based on the PEDro (Physiotherapy Evidence Database) scores and the Sackett's levels of evidence. A meta-analysis was performed for all three considered outcomes. Results. The results of the meta-analyses showed a significant difference in shoulder subluxation in experimental groups compared to control groups, only if FES was applied early after stroke. No effects were found on pain or motor function outcomes. Conclusion. FES can be used to prevent or reduce shoulder subluxation early after stroke. However, it should not be used to reduce pain or improve upper arm motor function after stroke. PMID:25685805

No Telescoping Effect with Dual Tendon Vibration

PubMed Central

Bellan, Valeria; Wallwork, Sarah B.; Stanton, Tasha R.; Reverberi, Carlo; Gallace, Alberto; Moseley, G. Lorimer

2016-01-01

The tendon vibration illusion has been extensively used to manipulate the perceived position of one’s own body part. However, findings from previous research do not seem conclusive sregarding the perceptual effect of the concurrent stimulation of both agonist and antagonist tendons over one joint. On the basis of recent data, it has been suggested that this paired stimulation generates an inconsistent signal about the limb position, which leads to a perceived shrinkage of the limb. However, this interesting effect has never been replicated. The aim of the present study was to clarify the effect of a simultaneous and equal vibration of the biceps and triceps tendons on the perceived location of the hand. Experiment 1 replicated and extended the previous findings. We compared a dual tendon stimulation condition with single tendon stimulation conditions and with a control condition (no vibration) on both ‘upward-downward’ and ‘towards-away from the elbow’ planes. Our results show a mislocalisation towards the elbow of the position of the vibrated arm during dual vibration, in line with previous results; however, this did not clarify whether the effect was due to arm representation contraction (i.e., a ‘telescoping’ effect). Therefore, in Experiment 2 we investigated explicitly and implicitly the perceived arm length during the same conditions. Our results clearly suggest that in all the vibration conditions there was a mislocalisation of the entire arm (including the elbow), but no evidence of a contraction of the perceived arm length. PMID:27305112

Real-Time Verification of a High-Dose-Rate Iridium 192 Source Position Using a Modified C-Arm Fluoroscope

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

Nose, Takayuki, E-mail: nose-takayuki@nms.ac.jp; Chatani, Masashi; Otani, Yuki

Purpose: High-dose-rate (HDR) brachytherapy misdeliveries can occur at any institution, and they can cause disastrous results. Even a patient's death has been reported. Misdeliveries could be avoided with real-time verification methods. In 1996, we developed a modified C-arm fluoroscopic verification of an HDR Iridium 192 source position prevent these misdeliveries. This method provided excellent image quality sufficient to detect errors, and it has been in clinical use at our institutions for 20 years. The purpose of the current study is to introduce the mechanisms and validity of our straightforward C-arm fluoroscopic verification method. Methods and Materials: Conventional X-ray fluoroscopic images aremore » degraded by spurious signals and quantum noise from Iridium 192 photons, which make source verification impractical. To improve image quality, we quadrupled the C-arm fluoroscopic X-ray dose per pulse. The pulse rate was reduced by a factor of 4 to keep the average exposure compliant with Japanese medical regulations. The images were then displayed with quarter-frame rates. Results: Sufficient quality was obtained to enable observation of the source position relative to both the applicators and the anatomy. With this method, 2 errors were detected among 2031 treatment sessions for 370 patients within a 6-year period. Conclusions: With the use of a modified C-arm fluoroscopic verification method, treatment errors that were otherwise overlooked were detected in real time. This method should be given consideration for widespread use.« less

The Duration of Intestinal Immunity After an Inactivated Poliovirus Vaccine Booster Dose in Children Immunized With Oral Vaccine: A Randomized Controlled Trial

PubMed Central

John, Jacob; Giri, Sidhartha; Karthikeyan, Arun S; Lata, Dipti; Jeyapaul, Shalini; Rajan, Anand K; Kumar, Nirmal; Dhanapal, Pavithra; Venkatesan, Jayalakshmi; Mani, Mohanraj; Hanusha, Janardhanan; Raman, Uma; Moses, Prabhakar D; Abraham, Asha; Bahl, Sunil; Bandyopadhyay, Ananda S; Ahmad, Mohammad; Grassly, Nicholas C; Kang, Gagandeep

2017-01-01

Abstract Background In 2014, 2 studies showed that inactivated poliovirus vaccine (IPV) boosts intestinal immunity in children previously immunized with oral poliovirus vaccine (OPV). As a result, IPV was introduced in mass campaigns to help achieve polio eradication. Methods We conducted an open-label, randomized, controlled trial to assess the duration of the boost in intestinal immunity following a dose of IPV given to OPV-immunized children. Nine hundred healthy children in Vellore, India, aged 1–4 years were randomized (1:1:1) to receive IPV at 5 months (arm A), at enrollment (arm B), or no vaccine (arm C). The primary outcome was poliovirus shedding in stool 7 days after bivalent OPV challenge at 11 months. Results For children in arms A, B, and C, 284 (94.7%), 297 (99.0%), and 296 (98.7%), respectively, were eligible for primary per-protocol analysis. Poliovirus shedding 7 days after challenge was less prevalent in arms A and B compared with C (24.6%, 25.6%, and 36.4%, respectively; risk ratio 0.68 [95% confidence interval: 0.53–0.87] for A versus C, and 0.70 [0.55–0.90] for B versus C). Conclusions Protection against poliovirus remained elevated 6 and 11 months after an IPV boost, although at a lower level than reported at 1 month. Clinical Trials Registration CTRI/2014/09/004979. PMID:28003352

No Telescoping Effect with Dual Tendon Vibration.

PubMed

Bellan, Valeria; Wallwork, Sarah B; Stanton, Tasha R; Reverberi, Carlo; Gallace, Alberto; Moseley, G Lorimer

2016-01-01

The tendon vibration illusion has been extensively used to manipulate the perceived position of one's own body part. However, findings from previous research do not seem conclusive sregarding the perceptual effect of the concurrent stimulation of both agonist and antagonist tendons over one joint. On the basis of recent data, it has been suggested that this paired stimulation generates an inconsistent signal about the limb position, which leads to a perceived shrinkage of the limb. However, this interesting effect has never been replicated. The aim of the present study was to clarify the effect of a simultaneous and equal vibration of the biceps and triceps tendons on the perceived location of the hand. Experiment 1 replicated and extended the previous findings. We compared a dual tendon stimulation condition with single tendon stimulation conditions and with a control condition (no vibration) on both 'upward-downward' and 'towards-away from the elbow' planes. Our results show a mislocalisation towards the elbow of the position of the vibrated arm during dual vibration, in line with previous results; however, this did not clarify whether the effect was due to arm representation contraction (i.e., a 'telescoping' effect). Therefore, in Experiment 2 we investigated explicitly and implicitly the perceived arm length during the same conditions. Our results clearly suggest that in all the vibration conditions there was a mislocalisation of the entire arm (including the elbow), but no evidence of a contraction of the perceived arm length.

How different terminology for ductal carcinoma in situ impacts women's concern and treatment preferences: a randomised comparison within a national community survey

PubMed Central

McCaffery, Kirsten; Nickel, Brooke; Moynihan, Ray; Hersch, Jolyn; Teixeira-Pinto, Armando; Irwig, Les; Barratt, Alexandra

2015-01-01

Objective There have been calls to remove ‘carcinoma’ from terminology for in situ cancers such as ductal carcinoma in situ (DCIS), to reduce overdiagnosis and overtreatment. We investigated the effect of describing DCIS as ‘abnormal cells’ versus ‘pre-invasive breast cancer cells’ on women's concern and treatment preferences. Setting and participants Community sample of Australian women (n=269) who spoke English as their main language at home. Design Randomised comparison within a community survey. Women considered a hypothetical scenario involving a diagnosis of DCIS described as either ‘abnormal cells’ (arm A) or ‘pre-invasive breast cancer cells’ (arm B). Within each arm, the initial description was followed by the alternative term and outcomes reassessed. Results Women in both arms indicated high concern, but still indicated strong initial preferences for watchful waiting (64%). There were no differences in initial concern or preferences by trial arm. However, more women in arm A (‘abnormal cells’ first term) indicated they would feel more concerned if given the alternative term (‘pre-invasive breast cancer cells’) compared to women in arm B who received the terms in the opposite order (67% arm A vs 52% arm B would feel more concerned, p=0.001). More women in arm A also changed their preference towards treatment when the terminology was switched from ‘abnormal cells’ to ‘pre-invasive breast cancer cells’ compared to arm B. In arm A, 18% of women changed their preference to treatment while only 6% changed to watchful waiting (p=0.008). In contrast, there were no significant changes in treatment preference in arm B when the terminology was switched (9% vs 8% changed their stated preference). Conclusions In a hypothetical scenario, interest in watchful waiting for DCIS was high, and changing terminology impacted women's concern and treatment preferences. Removal of the cancer term from DCIS may assist in efforts towards reducing overtreatment. PMID:26525720

A method of percutaneous vertebroplasty under the guidance of two C-arm fluoroscopes

PubMed Central

Xu, Ren-Jie; Yan, Yong-Qing; Chen, Guang-Xiang; Zou, Tian-Ming; Cai, Xiao-Qiang; Wang, Dong-Lai

2014-01-01

Objective: To compare the clinical application in the percutaneous vertebroplasty under the guidance of one or two C-arm fluoroscopes. Methods: One hundred forty three elderly patients with Osteoporotic vertebral compression fractures (OVCFs) underwent percutaneous vertebroplasty under the guidance of one or two C-arm fluoroscopes. The number of pulsed imagings, the time of operation and the incidence of cement leakage were recorded. Results: The average number of pulsed imagings was 16.00±1.58 vs 13.07±2.00 per patient under the guidance of one vs two C-arm fluoroscopes. The average time of operation was 48.42±5.00 minutes vs 39.70±7.42 minutes per patient under the guidance of one vs two C-arm fluoroscopes. The incidence of cement leakage was 20% vs 15.7% of the patients under the guidance of one vs two C-arm fluoroscopes. The differences in the number of pulsed imagings and the time of operation were statistically significant. The difference in incidence of cement leakage was not statistically significant. Conclusion: The two-fluoroscopic technique reduce the labor cost, the radiation, the time of operation and the operation risk. PMID:24772138

The Effect of High-Intensity Interval Cycling Sprints Subsequent to Arm-Curl Exercise on Upper-Body Muscle Strength and Hypertrophy.

PubMed

Kikuchi, Naoki; Yoshida, Shou; Okuyama, Mizuki; Nakazato, Koichi

2016-08-01

Kikuchi, N, Yoshida, S, Okuyama, M, and Nakazato, K. The effect of high-intensity interval cycling sprints subsequent to arm-curl exercise on upper-body muscle strength and hypertrophy. J Strength Cond Res 30(8): 2318-2323, 2016-The purpose of this study was to examine whether lower limb sprint interval training (SIT) after arm resistance training (RT) influences training response of arm muscle strength and hypertrophy. Twenty men participated in this study. We divided subjects into RT group (n = 6) and concurrent training group (CT, n = 6). The RT program was designed to induce muscular hypertrophy (3 sets × 10 repetitions [reps] at 80% 1 repetition maximum [1RM] of arm-curl exercise) and was performed in an 8-week training schedule performed 3 times per week on nonconsecutive days. Subjects assigned to the CT group performed identical protocols as strength training and modified SIT (4 sets of 30-s maximal effort, separated in 4 m 30-s rest intervals) on the same day. Pretest and posttest maximal oxygen consumption (V[Combining Dot Above]O2max), muscle cross-sectional area (CSA), and 1RM were measured. Significant increase in V[Combining Dot Above]O2max from pretest to posttest was observed in the CT group (p = 0.010, effect size [ES] = 1.84) but not in the RT group (p = 0.559, ES = 0.35). Significant increase in CSA from pretest to posttest was observed in the RT group (p = 0.030, ES = 1.49) but not in the CT group (p = 0.110, ES = 1.01). Significant increase in 1RM from pretest to posttest was observed in the RT group (p = 0.021, ES = 1.57) but not in the CT group (p = 0.065, ES = 1.19). In conclusion, our data indicate that concurrent lower limb SIT interferes with arm muscle hypertrophy and strength.

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

A phase I/pharmacokinetic study of sunitinib in combination with highly active antiretroviral therapy (HAART) in HIV-positive patients with cancer: AIDS Malignancy Consortium Trial AMC 061

PubMed Central

Rudek, Michelle A; Moore, Page C.; Mitsuyasu, Ronald T.; Dezube, Bruce J.; Aboulafia, David; Gerecitano, John; Sullivan, Ryan; Cianfrocca, Mary E.; Henry, David H.; Ratner, Lee; Haigentz, Missak; Dowlati, Afshin; Little, Richard F.; Ivy, S. Percy; Deeken, John F.

2014-01-01

Background Treatment of non-AIDS defining cancers (NADCs) may be complicated by drug interactions between highly active antiretroviral therapy (HAART) and chemotherapy. This trial is the first by the AIDS Malignancy Consortium assessing targeted therapies and HAART in HIV+ cancer patients (ClinicalTrials.gov NCT00890747). Methods Patients were stratified into two arms based on whether they were taking ritonavir, a potent CYP3A4 inhibitor, in a modified phase I study of sunitinib. Patients in arm 1 (non-ritonavir HAART) received standard sunitinib dosing (50mg/day). Arm 2 (ritonavir-based HAART) used a phase I, 3+3 dose escalation design (from 25 to 50mg/day). Cycles were with four weeks on treatment followed by a two week break (6 weeks total). Pharmacokinetics of sunitinib and its active metabolite (N-desethyl sunitinib) were assessed. Results Nineteen patients were enrolled and evaluable. Patients on Arm 1 tolerated treatment with one observed dose limiting toxicity (DLT). In Arm 2, a DLT was experienced at 37.5mg, and an additional 3 of 5 patients experienced grade 3 neutropenia, an uncommon toxicity of sunitinib. No patient had a response, but 10 had stable disease, including 8 with prolonged disease stability. Efavirenz, a potent inducer of CYP3A4, resulted in increased exposure of N-desethyl sunitinib, whereas ritonavir caused decreased exposure of the metabolite. Hand-foot syndrome was associated with higher steady-state trough concentrations of sunitinib. Conclusions Patients on non-ritonavir based HAART regimens tolerated standard dosing of sunitinib. Patients on ritonavir-based therapy treated with 37.5mg/day experienced higher toxicities. Dose reduction of sunitinib to 37.5mg may be warranted in patients on ritonavir. PMID:24474568

Psychologic Intervention Improves Survival for Breast Cancer Patients

PubMed Central

Andersen, Barbara L.; Yang, Hae-Chung; Farrar, William B.; Golden-Kreutz, Deanna M.; Emery, Charles F.; Thornton, Lisa M.; Young, Donn C.; Carson, William E.

2009-01-01

BACKGROUND The question of whether stress poses a risk for cancer progression has been difficult to answer. A randomized clinical trial tested the hypothesis that cancer patients coping with their recent diagnosis but receiving a psychologic intervention would have improved survival compared with patients who were only assessed. METHODS A total of 227 patients who were surgically treated for regional breast cancer participated. Before beginning adjuvant cancer therapies, patients were assessed with psychologic and behavioral measures and had a health evaluation, and a 60-mL blood sample was drawn. Patients were randomized to Psychologic Intervention plus assessment or Assessment only study arms. The intervention was psychologist led; conducted in small groups; and included strategies to reduce stress, improve mood, alter health behaviors, and maintain adherence to cancer treatment and care. Earlier articles demonstrated that, compared with the Assessment arm, the Intervention arm improved across all of the latter secondary outcomes. Immunity was also enhanced. RESULTS After a median of 11 years of follow-up, disease recurrence was reported to occur in 62 of 212 (29%) women and death was reported for 54 of 227 (24%) women. Using Cox proportional hazards analysis, multivariate comparison of survival was conducted. As predicted, patients in the Intervention arm were found to have a reduced risk of breast cancer recurrence (hazards ratio [HR] of 0.55; P=.034) and death from breast cancer (HR of 0.44; P=.016) compared with patients in the Assessment only arm. Follow-up analyses also demonstrated that Intervention patients had a reduced risk of death from all causes (HR of 0.51; P=.028). CONCLUSIONS Psychologic interventions as delivered and studied here can improve survival. PMID:19016270

FUNCTIONAL OUTCOMES AFTER DISTAL BICEPS BRACHII REPAIR: A CASE SERIES

PubMed Central

Morris, Tim; Otto, Charissa; Zerella, Tanisha; Semmler, John G; Human, Taaibos; Phadnis, Joideep; Bain, Gregory I

2016-01-01

Objectives To investigate outcomes after surgical repair of distal biceps tendon rupture and the influence of arm dominance on isokinetic flexion and supination results. Background/Purpose While relatively uncommon, rupture of the distal biceps tendon can result in significant strength deficits, for which surgical repair is recommended. The purpose of this study was to assess patient reported functional outcomes and muscle performance following surgery. Methods A sample of 23 participants (22 males, 1 female), who had previously undergone surgical repair of the distal biceps tendon, were re-examined at a minimum of one year after surgery. Biodex isokinetic elbow flexion and supination testing was performed to assess strength (as measured by peak torque) and endurance (as measured by total work and work fatigue). The Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) and Mayo Elbow Performance Scale (MEPS) were used to assess participants' subjectively reported functional recovery. Results At a mean of 7.6 years after surgical repair, there were no differences between the repaired and uninvolved elbows in peak torque (p = 0.47) or total work (p = 0.60) for flexion or supination. There was also no difference in elbow flexion work fatigue (p = 0.22). However, there was significantly less work fatigue in supination, which was likely influenced by arm dominance, as most repairs were to the dominant arm, F(1,22)=5.67, p = 0.03. Conclusion The long-term strength of the repaired elbow was similar to the uninvolved elbow after surgery to the distal biceps tendon. Endurance of the repaired elbow was similar in flexion but greater in supination, probably influenced by arm dominance. Study design Retrospective case series Level of Evidence Level 4 PMID:27904798

Efficacy and Safety of Lopinavir/ritonavir- versus Efavirenz-based Antiretroviral Therapy in HIV-Infected Pregnant Ugandan Women

PubMed Central

COHAN, Deborah; NATUREEBA, Paul; KOSS, Catherine A.; PLENTY, Albert; LUWEDDE, Flavia; MWESIGWA, Julia; ADES, Veronica; CHARLEBOIS, Edwin D.; GANDHI, Monica; CLARK, Tamara D.; NZARUBARA, Bridget; ACHAN, Jane; RUEL, Theodore; KAMYA, Moses R.; HAVLIR, Diane V.

2015-01-01

Objective Combination antiretroviral therapy (ART) is now the global standard for HIV-infected pregnant and breastfeeding women at all CD4 cell counts. We compared the efficacy and safety of an efavirenz versus lopinavir/ritonavir regimen for HIV-infected pregnant women initiating ART in rural Uganda. Design Randomized clinical trial. Methods We performed a planned secondary analysis comparing viral load suppression (HIV-1 RNA ≤400 copies/ml), safety, and HIV transmission to infants in a trial designed to test the hypothesis that lopinavir/ritonavir- versus efavirenz-based ART would reduce placental malaria (PROMOTE, ClinicalTrials.gov, NCT00993031). HIV-infected, ART-naïve pregnant women at 12–28 weeks gestation and any CD4 cell count were randomized. ART was provided and participants were counseled to breastfeed for one year postpartum. Results The median age of the 389 study participants was 29 years; median CD4 cell count was 370 cells/mm3. At delivery, virologic suppression was 97.6% in the efavirenz arm and 86.0% in the lopinavir/ritonavir arm, p <0.001. At 48 weeks postpartum, 91.0% of women on efavirenz and 88.4% on lopinavir/ritonavir had viral suppression, p = 0.49. Grade 1 or 2 gastrointestinal adverse events were higher among women on lopinavir/ritonavir versus efavirenz. Only two infants acquired HIV (both in the lopinavir/ritonavir arm) and HIV-free infant survival was similar between study arms: 92.9% (lopinavir/ritonavir) versus 97.2% (efavirenz), p = 0.10. Conclusions Virologic suppression at delivery was higher with an efavirenz- versus lopinavir/ritonavir-based regimen. However, women in both arms achieved high levels of virologic suppression through one year postpartum and the risk of transmission to infants was low. PMID:25426808

The Impact of Peer Support and mp3 Messaging on Adherence to Inhaled Corticosteroids in Minority Adolescents with Asthma: A Randomized Controlled Trial

PubMed Central

Mosnaim, Giselle; Li, Hong; Martin, Molly; Richardson, DeJuran; Belice, Paula Jo; Avery, Elizabeth; Ryan, Norman; Bender, Bruce; Powell, Lynda

2013-01-01

Background Poor adherence to inhaled corticosteroids (ICS) is a critical risk factor contributing to asthma morbidity among low-income minority adolescents. Objective This trial tested whether peer support group meetings and peer asthma messages delivered via mp3 players improved adherence to ICS. Methods Low-income African American and/or Hispanic adolescents, ages 11–16, with persistent asthma, and poor (≤ 48%) adherence to prescription ICS during the 3-week run-in were randomized to intervention or attention control groups (ATG) for the 10-week treatment. During treatment, the intervention arm participated in weekly coping peer group support sessions and received mp3 peer-recorded asthma messages promoting adherence. The ATG participated in weekly meetings with a research assistant and received an equivalent number of mp3 doctor-recorded asthma messages. Adherence was measured using self-report and the DoserCT, (Meditrac, Inc.), an electronic dose counter. The primary outcome was the difference in adherence at 10 weeks between the two arms. Results Thirty-four subjects were randomized to each arm. At 10 weeks, no statistical difference in objectively measured adherence could be detected between the two arms adjusting for baseline adherence (P = 0.929). Adherence declined in both groups over the course of the active treatment period. Participants’ in both study arms self-reported adherence was significantly higher than their objectively measured adherence at week 10 (P < 0.0001). Conclusion Improving medication adherence in longitudinal studies is challenging. Peer support and mp3-delivered peer asthma messages may not be of sufficient dose to improve outcomes. PMID:24565620

Impact of Precision Medicine in Diverse Cancers: A Meta-Analysis of Phase II Clinical Trials

PubMed Central

Schwaederle, Maria; Zhao, Melissa; Lee, J. Jack; Eggermont, Alexander M.; Schilsky, Richard L.; Mendelsohn, John; Lazar, Vladimir; Kurzrock, Razelle

2015-01-01

Purpose The impact of a personalized cancer treatment strategy (ie, matching patients with drugs based on specific biomarkers) is still a matter of debate. Methods We reviewed phase II single-agent studies (570 studies; 32,149 patients) published between January 1, 2010, and December 31, 2012 (PubMed search). Response rate (RR), progression-free survival (PFS), and overall survival (OS) were compared for arms that used a personalized strategy versus those that did not. Results Multivariable analysis (both weighted multiple linear regression and random effects meta-regression) demonstrated that the personalized approach, compared with a nonpersonalized approach, consistently and independently correlated with higher median RR (31% v 10.5%, respectively; P < .001) and prolonged median PFS (5.9 v 2.7 months, respectively; P < .001) and OS (13.7 v 8.9 months, respectively; P < .001). Nonpersonalized targeted arms had poorer outcomes compared with either personalized targeted therapy or cytotoxics, with median RR of 4%, 30%, and 11.9%, respectively; median PFS of 2.6, 6.9, and 3.3 months, respectively (all P < .001); and median OS of 8.7, 15.9, and 9.4 months, respectively (all P < .05). Personalized arms using a genomic biomarker had higher median RR and prolonged median PFS and OS (all P ≤ .05) compared with personalized arms using a protein biomarker. A personalized strategy was associated with a lower treatment-related death rate than a nonpersonalized strategy (median, 1.5% v 2.3%, respectively; P < .001). Conclusion Comprehensive analysis of phase II, single-agent arms revealed that, across malignancies, a personalized strategy was an independent predictor of better outcomes and fewer toxic deaths. In addition, nonpersonalized targeted therapies were associated with significantly poorer outcomes than cytotoxic agents, which in turn were worse than personalized targeted therapy. PMID:26304871

Risk Factors for the Development of Heterotopic Ossification in Seriously Burned Adults: A NIDRR Burn Model System Database Analysis

PubMed Central

Levi, Benjamin; Jayakumar, Prakash; Giladi, Avi; Jupiter, Jesse B.; Ring, David C.; Kowalske, Karen; Gibran, Nicole S.; Herndon, David; Schneider, Jeffrey C.; Ryan, Colleen M.

2015-01-01

Purpose Heterotopic ossification (HO) is a debilitating complication of burn injury; however, incidence and risk factors are poorly understood. In this study we utilize a multicenter database of adults with burn injuries to identify and analyze clinical factors that predict HO formation. Methods Data from 6 high-volume burn centers, in the Burn Injury Model System Database, were analyzed. Univariate logistic regression models were used for model selection. Cluster-adjusted multivariate logistic regression was then used to evaluate the relationship between clinical and demographic data and the development of HO. Results Of 2,979 patients in the database with information on HO that addressed risk factors for development of HO, 98 (3.5%) developed HO. Of these 98 patients, 97 had arm burns, and 96 had arm grafts. Controlling for age and sex in a multivariate model, patients with >30% total body surface area (TBSA) burn had 11.5x higher odds of developing HO (p<0.001), and those with arm burns that required skin grafting had 96.4x higher odds of developing HO (p=0.04). For each additional time a patient went to the operating room, odds of HO increased 30% (OR 1.32, p<0.001), and each additional ventilator day increase odds 3.5% (OR 1.035, p<0.001). Joint contracture, inhalation injury, and bone exposure did not significantly increase odds of HO. Conclusion Risk factors for HO development include >30% TBSA burn, arm burns, arm grafts, ventilator days, and number of trips to the operating room. Future studies can use these results to identify highest-risk patients to guide deployment of prophylactic and experimental treatments. PMID:26496115

[Radiative and hygienic certification in Armed Forces, problems of its implementation and ways of perfection].

PubMed

Rusakov, V N; Cherkashin, A V; Shishkanov, A P; Ian'shin, L A; Gracheva, T N

2010-12-01

Radiative and hygienic passportization is one of the most actual pattern of socio and hygienic monitoring in Armed Forces. Radiative and hygienic passport is the main document which characterizes the safety control in military unit and uses the sources of ionizing radiation. Sanitary and epidemiologic institutions were imputed to control the formation of radiative and hygienic passports, analysis and generalization of its data, formation of conclusions about the condition of radiation security in the military units. According to radiative and hygienic passportization, which took place in 2009, the radiation security in the Armed Forces and organizations is satisfactory, but there are some problems of providing of radiation security of personnel under the professional and medical radiation. The salvation of its problems requires the effective work of official functionary of radiac object and institutions of state sanitary and epidemiological supervision in Armed Forces of Russian Federation.

Reconciling the effects of screening on prostate cancer mortality in the ERSPC and PLCO trials

PubMed Central

Tsodikov, Alex; Gulati, Roman; Heijnsdijk, Eveline AM; Pinsky, Paul F; Moss, Sue M; Qiu, Sheng; de Carvalho, Tiago M; Hugosson, Jonas; Berg, Christine D; Auvinen, Anssi; Andriole, Gerald L; Roobol, Monique J; Crawford, E David; Nelen, Vera; Kwiatkowski, Maciej; Zappa, Marco; Luján, Marcos; Villers, Arnauld; Feuer, Eric J; de Koning, Harry J; Mariotto, Angela B; Etzioni, Ruth

2017-01-01

Background The European Randomized Study of Screening for Prostate Cancer (ERSPC) found screening reduced prostate cancer (PC) mortality, but the Prostate, Lung, Colorectal, and Ovarian trial (PLCO) found no reduction. Objective To evaluate whether effects of screening on PC mortality relative to no screening differed between the ERSPC and PLCO. Design Cox regression of PC death in each trial arm adjusted for age and trial, and extended analyses that accounted for increased incidence due to screening and diagnostic workup on each arm via mean lead times (MLTs). MLTs were estimated empirically and using analytic or microsimulation models. Setting Randomized controlled trials in Europe and the US. Participants Men aged 55–69 (ERSPC) or 55–74 (PLCO) at randomization. Intervention Prostate cancer screening. Measurements PC incidence and survival from randomization; PC incidence in the US before screening began. Results Estimated MLTs were similar in the ERSPC and PLCO intervention arms but were longer in the PLCO control arm than the ERSPC control arm. Extended analyses found no evidence that effects of screening differed between trials (P=0.37–0.47, range across MLT estimation approaches) but strong evidence that benefit increased with MLT (P=0.0027–0.0032). Screening was estimated to confer a 7–9% reduction in PC death per year of MLT. This translated into an estimated 25–31% and 27–32% lower risk of PC death under screening as performed in the ERSPC and PLCO intervention arms, respectively, relative to no screening. Limitations MLT is a simple metric of screening and diagnostic workup. Conclusion After accounting for differences in implementation and settings, the ERSPC and PLCO provide compatible evidence that screening reduces PC mortality. PMID:28869989

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

PubMed Central

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

2013-01-01

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

Inpatient versus Outpatient Management of TIA or Minor Stroke: Clinical Outcome

PubMed Central

Majidi, Shahram; Leon Guerrero, Christopher R.; Burger, Kathleen M.; Rothrock, John F.

2017-01-01

Background The management of patients with acute transient ischemic attack (TIA) or minor stroke is highly variable. Whether hospitalization of such patients significantly improves short-term clinical outcome is unknown. We assessed the short-term clinical outcome associated with inpatient versus outpatient management of patients with TIA or minor stroke. Methods We evaluated a consecutive series of patients with acute TIA or minor ischemic stroke (NIH Stroke Scale score ≤ 3) presenting to a single emergency department (ED). We randomized patients to either hospital-based or outpatient-based management. All patients underwent interview and examination 7–10 days following the index event. Results This study included 100 patients, 41 with TIA and 59 with minor stroke. Nineteen (46%) of the TIA patients and 29 (49%) of the minor stroke patients randomized to hospital management, and the remaining 22 TIA patients and 30 minor stroke patients randomized to outpatient-based management. In the patients with a minor stroke, neurologic worsening occurred in 6 out of 29 (21%) in the inpatient arm compared with 3 out of 30 (10%) in the outpatient arm (p = 0.3). In none of these cases was acute interventional therapy or need for urgent admission considered medically appropriate. In the patients with a TIA, recurrence of a TIA occurred in 2 out of 19 (11%) in the inpatient arm compared with 2 out of 22 (9%) in the outpatient arm (p = 1). None of the patients with a TIA randomized to the inpatient arm experienced a stroke compared with 1 out of 22 in the outpatient arm (p = 1). There were no deaths in either group. Conclusion Routine hospitalization of all patients with TIA or minor ischemic stroke may not positively affect short-term clinical outcome. PMID:28702120

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

PubMed

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

2017-11-10

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

Non-invasive assessment of vasospasm following aneurysmal SAH using C-arm FDCT parenchymal blood volume measurement in the neuro-interventional suite: Technical feasibility

PubMed Central

Downer, Jonathan; Corkill, Rufus; Byrne, James V

2015-01-01

Introduction Cerebral vasospasm is the leading cause of morbidity and mortality in patients with aneurysmal subarachnoid haemorrhage (SAH) surviving the initial ictus. Commonly used techniques for vasospasm assessment are digital subtraction angiography and transcranial Doppler sonography. These techniques can reliably identify only the major vessel spasm and fail to estimate its haemodynamic significance. To overcome these issues and to enable comprehensive non-invasive assessment of vasospasm inside the interventional suite, a novel protocol involving measurement of parenchymal blood volume (PBV) using C-arm flat detector computed tomography (FDCT) was implemented. Materials and methods Patients from the neuro-intensive treatment unit (ITU) with suspected vasospasm following aneurysmal SAH were scanned with a biplane C-arm angiography system using an intravenous contrast injection protocol. The PBV maps were generated using prototype software. Contemporaneous clinically indicated MR scan including the diffusion- and perfusion-weighted sequences was performed. C-arm PBV maps were compared against the MR perfusion maps. Results Distribution of haemodynamic impairment on C-arm PBV maps closely matched the pattern of abnormality on MR perfusion maps. On visual comparison between the two techniques, the extent of abnormality indicated PBV to be both cerebral blood flow and cerebral blood volume weighted. Conclusion C-arm FDCT PBV measurements allow an objective assessment of the severity and localisation of cerebral hypoperfusion resulting from vasospasm. The technique has proved feasible and useful in very sick patients after aneurysmal SAH. The promise shown in this early study indicates that it deserves further evaluation both for post-SAH vasospasm and in other relevant clinical settings. PMID:26017197

Time density curve analysis for C-arm FDCT PBV imaging

PubMed Central

Byrne, James V

2016-01-01

Introduction Parenchymal blood volume (PBV) estimation using C-arm flat detector computed tomography (FDCT) assumes a steady-state contrast concentration in cerebral vasculature for the scan duration. Using time density curve (TDC) analysis, we explored if the steady-state assumption is met for C-arm CT PBV scans, and how consistent the contrast-material dynamics in cerebral vasculature are across patients. Methods Thirty C-arm FDCT datasets of 26 patients with aneurysmal-SAH, acquired as part of a prospective study comparing C-arm CT PBV with MR-PWI, were analysed. TDCs were extracted from the 2D rotational projections. Goodness-of-fit of TDCs to a steady-state horizontal-line-model and the statistical similarity among the individual TDCs were tested. Influence of the differences in TDC characteristics on the agreement of resulting PBV measurements with MR-CBV was calculated. Results Despite identical scan parameters and contrast-injection-protocol, the individual TDCs were statistically non-identical (p < 0.01). Using Dunn's multiple comparisons test, of the total 435 individual comparisons among the 30 TDCs, 330 comparisons (62%) reached statistical significance for difference. All TDCs deviated significantly (p < 0.01) from the steady-state horizontal-line-model. PBV values of those datasets for which the TDCs showed largest deviations from the steady-state model demonstrated poor agreement and correlation with MR-CBV, compared with the PBV values of those datasets for which the TDCs were closer to steady-state. Conclusion For clinical C-arm CT PBV examinations, the administered contrast material does not reach the assumed ‘ideal steady-state’ for the duration of scan. Using a prolonged injection protocol, the degree to which the TDCs approximate the ideal steady-state influences the agreement of resulting PBV measurements with MR-CBV. PMID:26769736

A phase III randomized trial comparing adjuvant concomitant chemoradiotherapy versus standard adjuvant chemotherapy followed by radiotherapy in operable node-positive breast cancer: Final results

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

Rouesse, Jacques; Lande, Brigitte de la; Bertheault-Cvitkovic, Frederique

Purpose: To compare concomitant and sequential adjuvant chemoradiotherapy regimens in node-positive, operable breast cancer patients. Methods and Materials: This was a randomized, French, multicenter, phase III trial enrolling 638 eligible women with prior breast surgery and positive axillary dissection. Patients in Arm A received 500 mg/m{sup 2} 5-fluorouracil, 12 mg/m{sup 2} mitoxantrone, and 500 mg/m{sup 2} cyclophosphamide, with concomitant radiotherapy (50 Gy {+-} 10-20-Gy boost). Patients in Arm B received 500 mg/m{sup 2} 5-fluorouracil, 60 mg/m{sup 2} epirubicin, and 500 mg/m{sup 2} cyclophosphamide, with subsequent radiotherapy. Chemotherapy was administered on Day 1 every 21 days for 4 cycles. Results: Medianmore » treatment durations were 64 and 126 days (Arms A and B, respectively), with no significant difference in overall or disease-free survival. Five-year locoregional relapse-free survival favored patients with conservative surgery (two thirds of the population), with less local and/or regional recurrence in Arm A than in Arm B (3% vs. 9%; p 0.01). Multivariate analysis in this subgroup showed a 2.8-fold increased risk of locoregional recurrence with sequential chemoradiotherapy, independent of other prognostic factors (p = 0.027). Febrile neutropenia and Grade 3-4 leukopenia were significantly more frequent in Arm A. Subclinical left ventricular ejection fraction events at 1 year were more frequent with concomitant radiotherapy (p = 0.02). Conclusions: Concomitant radiotherapy with adjuvant fluorouracil, mitoxantrone, and cyclophosphamide has significantly better locoregional control in node-positive breast cancer after conservative surgery and 50% shorter treatment, albeit with slightly more acute toxicity. With mitoxantrone no longer available for adjuvant breast cancer treatment, alternative concomitant chemoradiotherapy studies are needed.« less

Understanding effects of armed conflict on health outcomes: the case of Nepal

PubMed Central

2010-01-01

Objective There is abundance of literature on adverse effects of conflict on the health of the population. In contrast to this, sporadic data in Nepal claim improvements in most of the health indicators during the decade-long armed conflict (1996-2006). However, systematic information to support or reject this claim is scant. This study reviews Nepal's key health indicators before and after the violent conflict and explores the possible factors facilitating the progress. Methods A secondary analysis has been conducted of two demographic health surveys-Nepal Family Health Survey (NFHS) 1996 and Nepal Demographic and Health Survey (NDHS) 2006; the latter was supplemented by a study carried out by the Nepal Health Research Council in 2006. Results The data show Nepal has made progress in 16 out of 19 health indicators which are part of the Millennium Development Goals whilst three indicators have remained static. Our analysis suggests a number of conflict and non-conflict factors which may have led to this success. Conclusion The lessons learnt from Nepal could be replicable elsewhere in conflict and post-conflict environments. A nationwide large-scale empirical study is needed to further assess the determinants of Nepal's success in the health sector at a time the country experienced a decade of armed conflict. PMID:21122098

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

PubMed Central

2012-01-01

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

Induction gemcitabine in standard dose or prolonged low-dose with cisplatin followed by concurrent radiochemotherapy in locally advanced non-small cell lung cancer: a randomized phase II clinical trial

PubMed Central

Vrankar, Martina; Zwitter, Matjaz; Bavcar, Tanja; Milic, Ana; Kovac, Viljem

2014-01-01

Background The optimal combination of chemotherapy with radiation therapy for treatment locally advanced non-small cell lung cancer (NSCLC) remains an open issue. This randomized phase II study compared gemcitabine in two different schedules and cisplatin - as induction chemotherapy, followed by radiation therapy concurrent with cisplatin and etoposid. Patients and methods. Eligible patients had microscopically confirmed inoperable non-metastatic non-small cell lung cancer; fulfilled the standard criteria for platin-based chemotherapy; and signed informed consent. Patients were treated with 3 cycles of induction chemotherapy with gemcitabine and cisplatin. Two different aplications of gemcitabine were compared: patients in arm A received gemcitabine at 1250 mg/m2 in a standard half hour i.v. infusion on days 1 and 8; patients in arm B received gemcitabine at 250 mg/m2 in prolonged 6-hours i.v. infusion on days 1 and 8. In both arms, cisplatin 75 mg/m2 on day 2 was administered. All patients continued treatment with radiation therapy with 60–66 Gy concurrent with cisplatin 50 mg/m2 on days 1, 8, 29 and 36 and etoposid 50 mg/m2 on days 1–5 and 29–33. The primary endpoint was response rate (RR) after induction chemotherapy; secondary endpoints were toxicity, progression-free survival (PFS) and overall survival (OS). Results From September 2005 to November 2010, 106 patients were recruited to this study. No statistically signifficant differences were found in RR after induction chemotherapy between the two arms (48.1% and 57.4%, p = 0.34). Toxicity profile was comparable and mild with grade 3/4 neutropenia as primary toxicity in both arms. One patient in arm B suffered from acute peripheral ischemia grade 4 and an amputation of lower limb was needed. With a median follow-up of 69.3 months, progression-free survival and median survival in arm A were 15.7 and 24.8 months compared to 18.9 and 28.6 months in arm B. The figures for 1- and 3-year overall survival were 73.1% and 30.8% in arm A, and 81.5 % and 44.4% in arm B, respectively. Conclusions Among the two cisplatin-based doublets of induction chemotherapy for inoperable NSCLC, both schedules of gemcitabine have a comparable toxicity profile. Figures for RR, PFS and OS are among the best reported in current literature. While there is a trend towards better efficacy of the treament with prolonged infusion of gemcitabine, the difference between the two arms did not reach statistical significance. PMID:25435850

Use of placebo controls in the evaluation of surgery: systematic review

PubMed Central

Judge, Andrew; Hopewell, Sally; Collins, Gary S; Dean, Benjamin J F; Rombach, Ines; Brindley, David; Savulescu, Julian; Beard, David J; Carr, Andrew J

2014-01-01

Objective To investigate whether placebo controls should be used in the evaluation of surgical interventions. Design Systematic review. Data sources We searched Medline, Embase, and the Cochrane Controlled Trials Register from their inception to November 2013. Study selection Randomised clinical trials comparing any surgical intervention with placebo. Surgery was defined as any procedure that both changes the anatomy and requires a skin incision or use of endoscopic techniques. Data extraction Three reviewers (KW, BJFD, IR) independently identified the relevant trials and extracted data on study details, outcomes, and harms from included studies. Results In 39 out of 53 (74%) trials there was improvement in the placebo arm and in 27 (51%) trials the effect of placebo did not differ from that of surgery. In 26 (49%) trials, surgery was superior to placebo but the magnitude of the effect of the surgical intervention over that of the placebo was generally small. Serious adverse events were reported in the placebo arm in 18 trials (34%) and in the surgical arm in 22 trials (41.5%); in four trials authors did not specify in which arm the events occurred. However, in many studies adverse events were unrelated to the intervention or associated with the severity of the condition. The existing placebo controlled trials investigated only less invasive procedures that did not involve laparotomy, thoracotomy, craniotomy, or extensive tissue dissection. Conclusions Placebo controlled trial is a powerful, feasible way of showing the efficacy of surgical procedures. The risks of adverse effects associated with the placebo are small. In half of the studies, the results provide evidence against continued use of the investigated surgical procedures. Without well designed placebo controlled trials of surgery, ineffective treatment may continue unchallenged. PMID:24850821

Relationship between isometric shoulder strength and arms-only swimming power among male collegiate swimmers: study of valid clinical assessment methods.

PubMed

Awatani, Takenori; Morikita, Ikuhiro; Mori, Seigo; Shinohara, Junji; Tatsumi, Yasutaka

2018-04-01

[Purpose] The purpose of the present study was to confirm the relationships between shoulder strength (extensor strength and internal rotator strength) of the abducted position and swimming power during arm-only swimming. [Subjects and Methods] Fourteen healthy male collegiate swimmers participated in the study. Main measures were shoulder strength (strength using torque that was calculated from the upper extremity length and the isometric force of the abducted position) and swimming power. [Results] Internal rotation torque of the dominant side in the abducted external rotated position (r=0.85) was significantly correlated with maximum swimming power. The rate of bilateral difference in extension torque in the maximum abducted position (r=-0.728) was significantly correlated with the swimming velocity-to-swimming power ratio. [Conclusion] The results of this study suggest that internal rotator strength measurement in the abducted external rotated position and extensor strength measurement in the maximum abducted position are valid assessment methods for swimmers.

Long-term effects of inhaled budesonide on screening-detected lung nodules

PubMed Central

Veronesi, G.; Lazzeroni, M.; Szabo, E.; Brown, P. H.; DeCensi, A.; Guerrieri-Gonzaga, A.; Bellomi, M.; Radice, D.; Grimaldi, M. C.; Spaggiari, L.; Bonanni, B.

2015-01-01

Background A previously carried out randomized phase IIb, placebo-controlled trial of 1 year of inhaled budesonide, which was nested in a lung cancer screening study, showed that non-solid and partially solid lung nodules detected by low-dose computed tomography (LDCT), and not immediately suspicious for lung cancer, tended to regress. Because some of these nodules may be slow-growing adenocarcinoma precursors, we evaluated long-term outcomes (after stopping the 1-year intervention) by annual LDCT. Patients and methods We analyzed the evolution of target and non-target trial nodules detected by LDCT in the budesonide and placebo arms up to 5 years after randomization. The numbers and characteristics of lung cancers diagnosed during follow-up were also analyzed. Results The mean maximum diameter of non-solid nodules reduced significantly (from 5.03 mm at baseline to 2.61 mm after 5 years) in the budesonide arm; there was no significant size change in the placebo arm. The mean diameter of partially solid lesions also decreased significantly, but only by 0.69 mm. The size of solid nodules did not change. Neither the number of new lesions nor the number of lung cancers differed in the two arms. Conclusions Inhaled budesonide given for 1 year significantly decreased the size of non-solid nodules detected by screening LDCT after 5 years. This is of potential importance since some of these nodules may progress slowly to adenocarcinoma. However, further studies are required to assess clinical implications. Clinical trial number NCT01540552. PMID:25672894

Motor impairment factors related to brain injury timing in early hemiparesis Part I: expression of upper extremity weakness

PubMed Central

Sukal-Moulton, Theresa; Krosschell, Kristin J.; Gaebler-Spira, Deborah J.; Dewald, Julius P.A.

2014-01-01

Background Extensive neuromotor development occurs early in human life, but the time that a brain injury occurs during development has not been rigorously studied when quantifying motor impairments. Objective This study investigated the impact of timing of brain injury on magnitude and distribution of weakness in the paretic arm of individuals with childhood-onset hemiparesis. Methods Twenty-four individuals with hemiparesis were divided into time periods of injury before birth (PRE-natal, n=8), around the time of birth (PERI-natal, n=8) or after 6 months of age (POST-natal, n=8). They, along with 8 typically developing peers, participated in maximal isometric shoulder, elbow, wrist, and finger torque generation tasks using a multiple degree-of-freedom load cell to quantify torques in 10 directions. A mixed model ANOVA was used to determine the effect of group and task on a calculated relative weakness ratio between arms. Results There was a significant effect of both time of injury group (p<0.001) and joint torque direction (p<0.001) on the relative weakness of the paretic arm. Distal joints were more affected compared to proximal joints, especially in the POST-natal group. Conclusions The distribution of weakness provides evidence for the relative preservation of ipsilateral corticospinal motor pathways to the paretic limb in those individuals injured earlier, while those who sustained later injury may rely more on indirect ipsilateral cortico-bulbospinal projections during the generation of torques with the paretic arm. PMID:24009182

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

Electromechanical analogs of human reflexes.

PubMed

Littman, M G; Liker, M; Stubbeman, W; Russakow, J; McGee, C; Gelfand, J; Call, B J

1989-01-01

The conclusion to be drawn from our modeling is that the combined stretch and tendon reflexes alone can endow artificial muscle with a springlike feel as well as give it a baseline tone. In response to questions that motor physiologists often ask as to what variables the system controls, the answer here is clear: the stretch and tendon reflexes act together to maintain both a tension set-point and a length set-point, but in so doing they also give the system a springlike feel because of the existence of a servo error. The main goal of our studies is to understand the integration of reflexes, and thus far we have only begun to explore the two lowest-level spinal reflexes. We are in the process of expanding this work by developing a much more refined arm explicitly modeled after the human arm. This new arm is to be activated by a minimum of 10 muscles, each of which is reflexively driven, and it will allow us to explore the integration of higher-level reflex action such as automatic inhibition of antagonists and facilitation of synergists.

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

PubMed Central

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

2013-01-01

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

Internet-Based Assessment of Oncology Health Care Professional Learning Style and Optimization of Materials for Web-Based Learning: Controlled Trial With Concealed Allocation

PubMed Central

Micheel, Christine M; Anderson, Ingrid A; Lee, Patricia; Chen, Sheau-Chiann; Justiss, Katy; Giuse, Nunzia B; Ye, Fei; Kusnoor, Sheila V

2017-01-01

Background Precision medicine has resulted in increasing complexity in the treatment of cancer. Web-based educational materials can help address the needs of oncology health care professionals seeking to understand up-to-date treatment strategies. Objective This study aimed to assess learning styles of oncology health care professionals and to determine whether learning style-tailored educational materials lead to enhanced learning. Methods In all, 21,465 oncology health care professionals were invited by email to participate in the fully automated, parallel group study. Enrollment and follow-up occurred between July 13 and September 7, 2015. Self-enrolled participants took a learning style survey and were assigned to the intervention or control arm using concealed alternating allocation. Participants in the intervention group viewed educational materials consistent with their preferences for learning (reading, listening, and/or watching); participants in the control group viewed educational materials typical of the My Cancer Genome website. Educational materials covered the topic of treatment of metastatic estrogen receptor-positive (ER+) breast cancer using cyclin-dependent kinases 4/6 (CDK4/6) inhibitors. Participant knowledge was assessed immediately before (pretest), immediately after (posttest), and 2 weeks after (follow-up test) review of the educational materials. Study statisticians were blinded to group assignment. Results A total of 751 participants enrolled in the study. Of these, 367 (48.9%) were allocated to the intervention arm and 384 (51.1%) were allocated to the control arm. Of those allocated to the intervention arm, 256 (69.8%) completed all assessments. Of those allocated to the control arm, 296 (77.1%) completed all assessments. An additional 12 participants were deemed ineligible and one withdrew. Of the 552 participants, 438 (79.3%) self-identified as multimodal learners. The intervention arm showed greater improvement in posttest score compared to the control group (0.4 points or 4.0% more improvement on average; P=.004) and a higher follow-up test score than the control group (0.3 points or 3.3% more improvement on average; P=.02). Conclusions Although the study demonstrated more learning with learning style-tailored educational materials, the magnitude of increased learning and the largely multimodal learning styles preferred by the study participants lead us to conclude that future content-creation efforts should focus on multimodal educational materials rather than learning style-tailored content. PMID:28743680

Reduction in PSA messenger-RNA expression and clinical recurrence in patients with prostatic cancer undergoing neoadjuvant therapy before radical prostatectomy

PubMed Central

Grasso, Marco; Lania, Caterina; Blanco, Salvatore; Baruffi, Marco; Mocellin, Simone

2004-01-01

Background We assessed the incidence of micro-metastases at surgical margins (SM) and pelvic lymph nodes (LN) in patients submitted to radical retropubic prostatectomy (RP) after neoadjuvant therapy (NT) or to RP alone. We compared traditional staging to molecular detection of PSA using Taqman-based quantitative real-time PCR (qrt-PCR) never used before for this purpose. Methods 29 patients were assigned to NT plus RP (arm A) or RP alone (arm B). Pelvic LN were dissected for qrt-PCR analysis, together with right and left lateral SM. Results 64,3% patients of arm B and 26.6% of arm A had evidence of PSA mRNA expression in LN and/or SM. 17,2% patients, all of arm B, had biochemical recurrence. Conclusions Qrt-PCR may be more sensitive, compared to conventional histology, in identifying presence of viable prostate carcinoma cells in SM and LN. Gene expression of PSA in surgical periprostatic samples might be considered as a novel and reliable indicator of minimal residual disease after NT. PMID:15104791

Evaluation of a solid matrix for collection and ambient storage of RNA from whole blood

PubMed Central

2014-01-01

Background Whole blood gene expression-based molecular diagnostic tests are becoming increasingly available. Conventional tube-based methods for obtaining RNA from whole blood can be limited by phlebotomy, volume requirements, and RNA stability during transport and storage. A dried blood spot matrix for collecting high-quality RNA, called RNA Stabilizing Matrix (RSM), was evaluated against PAXgene® blood collection tubes. Methods Whole blood was collected from 25 individuals and subjected to 3 sample storage conditions: 18 hours at either room temperature (baseline arm) or 37°C, and 6 days at room temperature. RNA was extracted and assessed for integrity by Agilent Bioanalyzer, and gene expression was compared by RT-qPCR across 23 mRNAs comprising a clinical test for obstructive coronary artery disease. Results RSM produced RNA of relatively high integrity across the various tested conditions (mean RIN ± 95% CI: baseline arm, 6.92 ± 0.24; 37°C arm, 5.98 ± 0.48; 6-day arm, 6.72 ± 0.23). PAXgene samples showed comparable RNA integrity in both baseline and 37°C arms (8.42 ± 0.17; 7.92 ± 0.1 respectively) however significant degradation was observed in the 6-day arm (3.19 ± 1.32). Gene expression scores on RSM were highly correlated between the baseline and 37°C and 6-day study arms (median r = 0.96, 0.95 respectively), as was the correlation to PAXgene tubes (median r = 0.95, p < 0.001). Conclusion RNA obtained from RSM shows little degradation and comparable RT-qPCR performance to PAXgene RNA for the 23 genes analyzed. Further development of this technology may provide a convenient method for collecting, shipping, and storing RNA for gene expression assays. PMID:24855452

Randomized Controlled Trial of a Video Decision Support Tool for Cardiopulmonary Resuscitation Decision Making in Advanced Cancer

PubMed Central

Volandes, Angelo E.; Paasche-Orlow, Michael K.; Mitchell, Susan L.; El-Jawahri, Areej; Davis, Aretha Delight; Barry, Michael J.; Hartshorn, Kevan L.; Jackson, Vicki Ann; Gillick, Muriel R.; Walker-Corkery, Elizabeth S.; Chang, Yuchiao; López, Lenny; Kemeny, Margaret; Bulone, Linda; Mann, Eileen; Misra, Sumi; Peachey, Matt; Abbo, Elmer D.; Eichler, April F.; Epstein, Andrew S.; Noy, Ariela; Levin, Tomer T.; Temel, Jennifer S.

2013-01-01

Purpose Decision making regarding cardiopulmonary resuscitation (CPR) is challenging. This study examined the effect of a video decision support tool on CPR preferences among patients with advanced cancer. Patients and Methods We performed a randomized controlled trial of 150 patients with advanced cancer from four oncology centers. Participants in the control arm (n = 80) listened to a verbal narrative describing CPR and the likelihood of successful resuscitation. Participants in the intervention arm (n = 70) listened to the identical narrative and viewed a 3-minute video depicting a patient on a ventilator and CPR being performed on a simulated patient. The primary outcome was participants' preference for or against CPR measured immediately after exposure to either modality. Secondary outcomes were participants' knowledge of CPR (score range of 0 to 4, with higher score indicating more knowledge) and comfort with video. Results The mean age of participants was 62 years (standard deviation, 11 years); 49% were women, 44% were African American or Latino, and 47% had lung or colon cancer. After the verbal narrative, in the control arm, 38 participants (48%) wanted CPR, 41 (51%) wanted no CPR, and one (1%) was uncertain. In contrast, in the intervention arm, 14 participants (20%) wanted CPR, 55 (79%) wanted no CPR, and 1 (1%) was uncertain (unadjusted odds ratio, 3.5; 95% CI, 1.7 to 7.2; P < .001). Mean knowledge scores were higher in the intervention arm than in the control arm (3.3 ± 1.0 v 2.6 ± 1.3, respectively; P < .001), and 65 participants (93%) in the intervention arm were comfortable watching the video. Conclusion Participants with advanced cancer who viewed a video of CPR were less likely to opt for CPR than those who listened to a verbal narrative. PMID:23233708

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

Le Blanche, Alain F.; Pautas, Eric; Gouin, Isabelle

Purpose. To evaluate routine use of access sites in the arm for percutaneous caval filter placement (PCFP) in elderly patients. Neck arthritis, patient anxiety, access site thrombosis or fecal/urinary incontinence complicating jugular or femoral access may require alternative access sites in this population. Methods. Access via the right arm was chosen for PCFP (VenaTech LP). The indication for PCFP was deep vein thrombosis, a history of pulmonary embolism, and a contraindication to anticoagulant therapy. Ultrasound-guided puncture was performed after diameter measurement of the arm veins (O{sub AV}). The filter was inserted with standard imaging procedures. Procedural difficulty was graded andmore » compared with O{sub AV} and the angle from the arm vein to the superior vena cava ({alpha}{sub AV/SVC}). Results. Over 2 years, 16 patients (14 women, 2 men) with an average age of 90 years (range 79-97 years) were included in the study. The average O{sub AV} value of the basilic or brachial veins was 4.2 mm (range 3.0-5.1 mm). The minimal O{sub AV} for successful access was determined after the first 15 patients. No hematoma occurred at the puncture sites. The average {alpha}{sub AV/SVC} value was 62 deg. (range 29 deg. - 90 deg.). Arm access was possible in 12 of 16 patients (75%) with O{sub AV} {>=} 3.5 mm and {alpha}{sub AV/SVC} {>=} 29 deg. Every procedure via the arm was graded 'easy' by the operator, regardless of angulation values. Femoral access was used in one case due to the impossibility of traversing the heart (patient no. 2), and jugular access was used in 3 of 16 (19%) patients due to puncture failure (patient no. 4), small O{sub AV} (3 mm) (patient no. 6), and stenosis of the distal right subclavian vein (patient no.16), respectively. Conclusion. PCFP via the arm can be routinely accomplished in patients older than 75 years, provided O{sub AV} {>=} 3.5 mm, and {alpha}{sub AV/SVC} {>=} 200119 d.« less

A systematic review of the etiopathogenesis of Kienböck's disease and a critical appraisal of its recognition as an occupational disease related to hand-arm vibration.

PubMed

Stahl, Stéphane; Stahl, Adelana Santos; Meisner, Christoph; Rahmanian-Schwarz, Afshin; Schaller, Hans-Eberhard; Lotter, Oliver

2012-11-21

We systematically reviewed etiological factors of Kienböck's disease (osteonecrosis of the lunate) discussed in the literature in order to examine the justification for including Kienböck's disease (KD) in the European Listing of Occupational Diseases. We searched the Ovid/Medline and the Cochrane Library for articles discussing the etiology of osteonecrosis of the lunate published since the first description of KD in 1910 and up until July 2012 in English, French or German. Literature was classified by the level of evidence presented, the etiopathological hypothesis discussed, and the author's conclusion about the role of the etiopathological hypothesis. The causal relationship between KD and hand-arm vibration was elucidated by the Bradford Hill criteria. A total of 220 references was found. Of the included 152 articles, 140 (92%) reached the evidence level IV (case series). The four most frequently discussed factors were negative ulnar variance (n=72; 47%), primary arterial ischemia of the lunate (n=63; 41%), trauma (n=63; 41%) and hand-arm vibration (n=53; 35%). The quality of the cohort studies on hand-arm vibration did not permit a meta-analysis to evaluate the strength of an association to KD. Evidence for the lack of consistency, plausibility and coherence of the 4 most frequently discussed etiopathologies was found. No evidence was found to support any of the nine Bradford Hill criteria for a causal relationship between KD and hand-arm vibration. A systematic review of 220 articles on the etiopathology of KD and the application of the Bradford Hill criteria does not provide sufficient scientific evidence to confirm or refute a causal relationship between KD and hand-arm vibration. This currently suggests that, KD does not comply with the criteria of the International Labour Organization determining occupational diseases. However, research with a higher level of evidence is required to further determine if hand-arm vibration is a risk factor for KD.

An Economic Evaluation of Home Versus Laboratory-Based Diagnosis of Obstructive Sleep Apnea

PubMed Central

Kim, Richard D.; Kapur, Vishesh K.; Redline-Bruch, Julie; Rueschman, Michael; Auckley, Dennis H.; Benca, Ruth M.; Foldvary-Schafer, Nancy R.; Iber, Conrad; Zee, Phyllis C.; Rosen, Carol L.; Redline, Susan; Ramsey, Scott D.

2015-01-01

Study Objectives: We conducted an economic analysis of the HomePAP study, a multicenter randomized clinical trial that compared home-based versus laboratory-based testing for the diagnosis and management of obstructive sleep apnea (OSA). Design: A cost-minimization analysis from the payer and provider perspectives was performed, given that 3-mo clinical outcomes were equivalent. Setting: Seven academic sleep centers. Participants: There were 373 subjects at high risk for moderate to severe OSA. Interventions: Subjects were randomized to either home-based limited channel portable monitoring followed by unattended autotitration with continuous positive airway pressure (CPAP), versus a traditional pathway of in-laboratory sleep study and CPAP titration. Measurements and Results: From the payer perspective, per subject costs for the laboratory-based pathway were $1,840 (95% confidence interval [CI] $1,660, $2,015) compared to $1,575 (95% CI $1,439, $1,716) for the home-based pathway under the base case. Costs were $264 (95% CI $39, $496, P = 0.02) in favor of the home arm. From the provider perspective, per subject costs for the laboratory arm were $1,697 (95% CI $1,566, $1,826) compared to $1,736 (95% CI $1,621, $1,857) in the home arm, for a difference of $40 (95% CI −$213, $142, P = 0.66) in favor of the laboratory arm under the base case. The provider operating margin was $142 (95% CI $85, $202,P < 0.01) in the laboratory arm, compared to a loss of −$161 (95% CI −$202, −$120, P < 0.01) in the home arm. Conclusions: For payers, a home-based diagnostic pathway for obstructive sleep apnea with robust patient support incurs fewer costs than a laboratory-based pathway. For providers, costs are comparable if not higher, resulting in a negative operating margin. Clinicaltrials.gov Identifier: NCT00642486. Citation: Kim RD, Kapur VK, Redline-Bruch J, Rueschman M, Auckley DH, Benca RM, Foldvary-Schafer NR, Iber C, Zee PC, Rosen CL, Redline S, Ramsey SD. An economic evaluation of home versus laboratory-based diagnosis of obstructive sleep apnea. SLEEP 2015;38(7):1027–1037. PMID:26118558

A comparison of QuantStudio™ 3D Digital PCR and ARMS-PCR for measuring plasma EGFR T790M mutations of NSCLC patients

PubMed Central

Sang, Yaxiong; Zhang, Jie; Wang, Ping; Wang, Yue; Liu, Bing; Lin, Dongmei; Yu, Yang; Fang, Jian

2018-01-01

Background The AURA3 clinical trial has shown that advanced non-small cell lung cancer (NSCLC) patients with EGFR T790M mutations in circulating tumor DNA (ctDNA) could benefit from osimertinib. Purpose The aim of this study was to assess the usefulness of QuantStudio™ 3D Digital PCR System platform for the detection of plasma EGFR T790M mutations in NSCLC patients, and compare the performances of 3D Digital PCR and ARMS-PCR. Patients and methods A total of 119 Chinese patients were enrolled in this study. Mutant allele frequency of plasma EGFR T790M was detected by 3D Digital PCR, then 25 selected samples were verified by ARMS-PCR and four of them were verified by next generation sequencing (NGS). Results In total, 52.94% (69/119) had EGFR T790M mutations detected by 3D Digital PCR. In 69 positive samples, the median mutant allele frequency (AF) was 1.09% and three cases presented low concentration (AF <0.1%). Limited by the amount of plasma DNA, 17 samples (AF <2.5%) and eight samples (T790M-) were selected for verification by ARMS-PCR. Four of those samples were verified by NGS as a third verification method. Among the selected 17 positive cases, ten samples presented mutant allele frequency <0.5%, and seven samples presented intermediate mutant allele frequency (0.5% AF 2.5%). However, only three samples (3/17) were identified as positive by ARMS-PCR, namely, P6 (AF =1.09%), P7 (AF =2.09%), and P8 (AF =2.21%). It is worth mentioning that sample P9 (AF =2.05%, analyzed by 3D Digital PCR) was identified as T790M- by ARMS-PCR. Four samples were identified as T790M+ by both NGS and 3D Digital PCR, and typically three samples (3/4) presented at a low ratio (AF <0.5%). Conclusion Our study demonstrated that 3D Digital PCR is a novel method with high sensitivity and specificity to detect EGFR T790M mutation in plasma. PMID:29403309

Efficacy of Ginger in Control of Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients Receiving Doxorubicin-Based Chemotherapy.

PubMed

Ansari, Mansour; Porouhan, Pezhman; Mohammadianpanah, Mohammad; Omidvari, Shapour; Mosalaei, Ahmad; Ahmadloo, Niloofar; Nasrollahi, Hamid; Hamedi, Seyed Hasan

2016-01-01

Nausea and vomiting are among the most serious side effects of chemotherapy, in some cases leading to treatment interruption or chemotherapy dose reduction. Ginger has long been known as an antiemetic drug, used for conditions such as motion sickness, nausea-vomiting in pregnancy, and post-operation side effects. One hundred and fifty female patients with breast cancer entered this prospective study and were randomized to receive ginger (500 mg ginger powder, twice a day for 3 days) or placebo. One hundred and nineteen patients completed the study: 57 of them received ginger and 62 received ginger for the frst 3 chemotherapy cycles. Mean age in all patients was 48.6 (25-79) years. After 1st chemotherapy, mean nausea in the ginger and control arms were 1.36 (±1.31) and 1.46 (±1.28) with no statistically significant difference. After the 2nd chemotherapy session, nausea score was slightly more in the ginger group (1.36 versus 1.32). After 3rd chemotherapy, mean nausea severity in control group was less than ginger group [1.37 (±1.14), versus 1.42 (±1.30)]. Considering all patients, nausea was slightly more severe in ginger arm. In ginger arm mean nausea score was 1.42 (±0.96) and in control arm it was 1.40 (±0.92). Mean vomiting scores after chemotherapy in ginger arm were 0.719 (±1.03), 0.68 (±1.00) and 0.77 (±1.18). In control arm, mean vomiting was 0.983 (±1.23), 1.03 (±1.22) and 1.15 (±1.27). In all sessions, ginger decreased vomiting severity from 1.4 (±1.04) to 0.71 (±0.86). None of the differences were significant. In those patients who received the AC regimen, vomiting was less severe (0.64±0.87) compared to those who received placebo (1.13±1.12), which was statistically significant (p-value <0.05). Further and larger studies are needed to draw conclusions.

Arm-specific dynamics of chromosome evolution in malaria mosquitoes

PubMed Central

2011-01-01

Background The malaria mosquito species of subgenus Cellia have rich inversion polymorphisms that correlate with environmental variables. Polymorphic inversions tend to cluster on the chromosomal arms 2R and 2L but not on X, 3R and 3L in Anopheles gambiae and homologous arms in other species. However, it is unknown whether polymorphic inversions on homologous chromosomal arms of distantly related species from subgenus Cellia nonrandomly share similar sets of genes. It is also unclear if the evolutionary breakage of inversion-poor chromosomal arms is under constraints. Results To gain a better understanding of the arm-specific differences in the rates of genome rearrangements, we compared gene orders and established syntenic relationships among Anopheles gambiae, Anopheles funestus, and Anopheles stephensi. We provided evidence that polymorphic inversions on the 2R arms in these three species nonrandomly captured similar sets of genes. This nonrandom distribution of genes was not only a result of preservation of ancestral gene order but also an outcome of extensive reshuffling of gene orders that created new combinations of homologous genes within independently originated polymorphic inversions. The statistical analysis of distribution of conserved gene orders demonstrated that the autosomal arms differ in their tolerance to generating evolutionary breakpoints. The fastest evolving 2R autosomal arm was enriched with gene blocks conserved between only a pair of species. In contrast, all identified syntenic blocks were preserved on the slowly evolving 3R arm of An. gambiae and on the homologous arms of An. funestus and An. stephensi. Conclusions Our results suggest that natural selection favors specific gene combinations within polymorphic inversions when distant species are exposed to similar environmental pressures. This knowledge could be useful for the discovery of genes responsible for an association of inversion polymorphisms with phenotypic variations in multiple species. Our data support the chromosomal arm specificity in rates of gene order disruption during mosquito evolution. We conclude that the distribution of breakpoint regions is evolutionary conserved on slowly evolving arms and tends to be lineage-specific on rapidly evolving arms. PMID:21473772

Do incentives undermine intrinsic motivation? Increases in intrinsic motivation within an incentive-based intervention for people living with HIV in Tanzania

PubMed Central

Dow, William H.; Njau, Prosper F.

2018-01-01

Background Cash and in-kind incentives can improve health outcomes in various settings; however, there is concern that incentives may ‘crowd out’ intrinsic motivation to engage in beneficial behaviors. We examined this hypothesis in a randomized trial of food and cash incentives for people living with HIV infection in Tanzania. Methods We analyzed data from 469 individuals randomized to one of three study arms: standard of care, short-term cash transfers, or short-term food assistance. Eligible participants were: 1) ≥18 years old; 2) HIV-infected; 3) food insecure; and 4) initiated antiretroviral therapy (ART) ≤90 days before the study. Food or cash transfers, valued at ~$11 per month and conditional on attending clinic visits, were provided for ≤6 months. Intrinsic motivation was measured at baseline, 6, and 12 months using the autonomous motivation section of the Treatment Self-Regulation Questionnaire (TSRQ). We compared the change in TSRQ score from baseline to 6 and 12 months and the change within study arms. Results The mean intrinsic motivation score was 2.79 at baseline (range: 1–3), 2.91 at 6 months (range: 1–3), and 2.95 at 12 months (range: 2–3), which was 6 months after the incentives had ended. Among all patients, the intrinsic motivation score increased by 0.13 points at 6 months (95% CI (0.09, 0.17), Cohen’s d = 0.29) and 0.19 points at 12 months (95% CI (0.14, 0.24), Cohen’s d = 0.49). Intrinsic motivation also increased within each study group at 6 months: 0.15 points in the food arm (95% CI (0.09, 0.21), Cohen’s d = 0.37), 0.11 points in the cash arm (95% CI (0.05, 0.18), Cohen’s d = 0.25), and 0.08 points in the comparison arm (95% CI (-0.03, 0.19), Cohen’s d = 0.21); findings were similar at 12 months. Increases in motivation were statistically similar between arms at 6 and 12 months. Conclusion Intrinsic motivation for ART adherence increased significantly both overall and within the food and cash incentive arms, even after the incentive period was over. Increases in motivation did not differ by study group. These results suggest that incentive interventions for treatment adherence should not be withheld due to concerns of crowding out intrinsic motivation. PMID:29902177

Effect of an environmental school-based obesity prevention program on changes in body fat and body weight: a randomized trial.

PubMed

Williamson, Donald A; Champagne, Catherine M; Harsha, David W; Han, Hongmei; Martin, Corby K; Newton, Robert L; Sothern, Melinda S; Stewart, Tiffany M; Webber, Larry S; Ryan, Donna H

2012-08-01

This study tested the efficacy of two school-based programs for prevention of body weight/fat gain in comparison to a control group, in all participants and in overweight children. The Louisiana (LA) Health study utilized a longitudinal, cluster randomized three-arm controlled design, with 28 months of follow-up. Children (N = 2,060; mean age = 10.5 years, SD = 1.2) from rural communities in grades 4-6 participated in the study. Seventeen school clusters (mean = 123 children/cluster) were randomly assigned to one of three prevention arms: (i) primary prevention (PP), an environmental modification (EM) program, (ii) primary + secondary prevention (PP+SP), the environmental program with an added classroom and internet education component, or (iii) control (C). Primary outcomes were changes in percent body fat and BMI z scores. Secondary outcomes were changes in behaviors related to energy balance. Comparisons of PP, PP+SP, and C on changes in body fat and BMI z scores found no differences. PP and PP+SP study arms were combined to create an EM arm. Relative to C, EM decreased body fat for boys (-1.7 ± 0.38% vs. -0.14 ± 0.69%) and attenuated fat gain for girls (2.9 ± 0.22% vs. 3.93 ± 0.37%), but standardized effect sizes were relatively small (<0.30). In conclusion, this school-based EM programs had modest beneficial effects on changes in percent body fat. Addition of a classroom/internet program to the environmental program did not enhance weight/fat gain prevention, but did impact physical activity and social support in overweight children.

Comparison of EP2006, a filgrastim biosimilar, to the reference: a phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy

PubMed Central

Blackwell, K.; Semiglazov, V.; Krasnozhon, D.; Davidenko, I.; Nelyubina, L.; Nakov, R.; Stiegler, G.; Singh, P.; Schwebig, A.; Kramer, S.; Harbeck, N.

2015-01-01

Background Biosimilars of filgrastim are in widespread clinical use in Europe. This phase III study compares biosimilar filgrastim (EP2006), with the US-licensed reference product, Neupogen®, in breast cancer patients receiving (neo)adjuvant myelosuppressive chemotherapy (TAC). Patients and methods A total of 218 patients receiving 5 µg/kg/day filgrastim over six chemotherapy cycles were randomized 1:1:1:1 into four arms. Two arms received only one product (nonalternating), biosimilar or reference, and two arms (alternating) received alternating treatments during each cycle (biosimilar then reference or vice versa). The primary end point was duration of severe neutropenia (DSN) during cycle 1. Results The baseline characteristics were balanced between the four treatment arms. Noninferiority of biosimilar versus the reference was demonstrated: DSN (days) in cycle 1 was 1.17 ± 1.11 (biosimilar, N = 101) and 1.20 ± 1.02 (reference, N = 103), 97.5% confidence interval lower boundary for the difference was −0.26 days (above the predefined limit of −1 day). No clinically meaningful differences were observed regarding any other efficacy parameter: incidence of febrile neutropenia (FN); hospitalization due to FN; incidence of infections; depth and time of absolute neutrophil count (ANC) nadir and time to ANC recovery during cycle 1 and across all cycles. The pattern and frequency of adverse events were similar across all treatments. Conclusion This study demonstrates that biosimilar and the reference filgrastim are similar with no clinically meaningful differences regarding efficacy and safety in prevention of severe neutropenia. Biosimilar filgrastim could represent an important alternative to the reference product, potentially benefiting public health by increasing access to filgrastim treatment. Study number NCT01519700. PMID:26122726

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

PubMed Central

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

2016-01-01

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

Effect of an Environmental School-based Obesity Prevention Program On Changes in Body Fat and Body Weight: A Randomized Trial

PubMed Central

Williamson, D.A.; Champagne, C.M.; Harsha, D.; Han, H.; Martin, C.K.; Newton, R.L.; Sothern, M.; Stewart, T.M.; Webber, L.S.; Ryan, D.

2012-01-01

This study tested the efficacy of two school-based programs for prevention of body weight/fat gain in comparison to a control group, in all participants and in overweight children. The Louisiana (LA) Health study utilized a longitudinal, cluster randomized 3-arm controlled design, with 28 months of follow-up. Children (N=2060; M age = 10.5 years, SD = 1.2) from rural communities in Grades 4 to 6 participated in the study. 17 school clusters (M = 123 children/cluster) were randomly assigned to one of three prevention arms: 1) Primary Prevention (PP), an environmental modification program, 2) Primary + Secondary Prevention (PP+SP), the environmental program with an added classroom and internet education component, or 3) Control (C). Primary outcomes were changes in percent body fat and body mass index z scores. Secondary outcomes were changes in behaviors related to energy balance. Comparisons of PP, PP+SP, and C on changes in body fat and BMI z scores found no differences. PP and PP+SP study arms were combined to create an environmental modification arm (EM). Relative to C, EM decreased body fat for boys (−1.7% ± 0.38% versus −0.14% ± 0.69%) and attenuated fat gain for girls (2.9% ± 0.22% versus 3.93% ± 0.37%), but standardized effect sizes were relatively small (< 0.30). In conclusion, this school-based environmental modification programs had modest beneficial effects on changes in percent body fat. Addition of a classroom/internet program to the environmental program did not enhance weight/fat gain prevention, but did impact physical activity and social support in overweight children. PMID:22402733

Case management reduces global vascular risk after stroke: secondary results from the The preventing recurrent vascular events and neurological worsening through intensive organized case-management randomized controlled trial.

PubMed

McAlister, Finlay A; Grover, Steven; Padwal, Raj S; Youngson, Erik; Fradette, Miriam; Thompson, Ann; Buck, Brian; Dean, Naeem; Tsuyuki, Ross T; Shuaib, Ashfaq; Majumdar, Sumit R

2014-12-01

Survivors of ischemic stroke/transient ischemic attack (TIA) are at high risk for other vascular events. We evaluated the impact of 2 types of case management (hard touch with pharmacist or soft touch with nurse) added to usual care on global vascular risk. This is a prespecified secondary analysis of a 6-month trial conducted in outpatients with recent stroke/TIA who received usual care and were randomized to additional monthly visits with either nurse case managers (who counseled patients, monitored risk factors, and communicated results to primary care physicians) or pharmacist case managers (who were also able to independently prescribe according to treatment algorithms). The Framingham Risk Score [FRS]) and the Cardiovascular Disease Life Expectancy Model (CDLEM) were used to estimate 10-year risk of any vascular event at baseline, 6 months (trial conclusion), and 12 months (6 months after last trial visit). Mean age of the 275 evaluable patients was 67.6 years. Both study arms were well balanced at baseline and exhibited reductions in absolute global vascular risk estimates at 6 months: median 4.8% (Interquartile range (IQR) 0.3%-11.3%) for the pharmacist arm versus 5.1% (IQR 1.9%-12.5%) for the nurse arm on the FRS (P = .44 between arms) and median 10.0% (0.1%-31.6%) versus 12.5% (2.1%-30.5%) on the CDLEM (P = .37). These reductions persisted at 12 months: median 6.4% (1.2%-11.6%) versus 5.5% (2.0%-12.0%) for the FRS (P = .83) and median 8.4% (0.1%-28.3%) versus 13.1% (1.6%-31.6%) on the CDLEM (P = .20). Case management by nonphysician providers is associated with improved global vascular risk in patients with recent stroke/TIA. Reductions achieved during the active phase of the trial persisted after trial conclusion. Copyright © 2014 Mosby, Inc. All rights reserved.

POLICY IMPLICATIONS OF ADJUSTING RANDOMIZED TRIAL DATA FOR ECONOMIC EVALUATIONS: A DEMONSTRATION FROM THE ASCUS-LSIL TRIAGE STUDY

PubMed Central

Campos, Nicole G.; Castle, Philip E.; Schiffman, Mark; Kim, Jane J.

2013-01-01

Background Although the randomized controlled trial (RCT) is widely considered the most reliable method for evaluation of health care interventions, challenges to both internal and external validity exist. Thus, the efficacy of an intervention in a trial setting does not necessarily represent the real-world performance that decision makers seek to inform comparative effectiveness studies and economic evaluations. Methods Using data from the ASCUS-LSIL Triage Study (ALTS), we performed a simplified economic evaluation of age-based management strategies to detect cervical intraepithelial neoplasia grade 3 (CIN3) among women who were referred to the study with low-grade squamous intraepithelial lesions (LSIL). We used data from the trial itself to adjust for 1) potential lead time bias and random error that led to variation in the observed prevalence of CIN3 by study arm, and 2) potential ascertainment bias among providers in the most aggressive management arm. Results We found that using unadjusted RCT data may result in counterintuitive cost-effectiveness results when random error and/or bias are present. Following adjustment, the rank order of management strategies changed for two of the three age groups we considered. Conclusion Decision analysts need to examine study design, available trial data and cost-effectiveness results closely in order to detect evidence of potential bias. Adjustment for random error and bias in RCTs may yield different policy conclusions relative to unadjusted trial data. PMID:22147881

HIV self-testing among female sex workers in Zambia: A cluster randomized controlled trial

PubMed Central

Chanda, Michael M.; Mwale, Magdalene; Chongo, Steven; Kanchele, Catherine; Kamungoma, Nyambe; Fullem, Andrew; Dunn, Caitlin; Barresi, Leah G.; Bärnighausen, Till

2017-01-01

Background HIV self-testing (HIVST) may play a role in addressing gaps in HIV testing coverage and as an entry point for HIV prevention services. We conducted a cluster randomized trial of 2 HIVST distribution mechanisms compared to the standard of care among female sex workers (FSWs) in Zambia. Methods and findings Trained peer educators in Kapiri Mposhi, Chirundu, and Livingstone, Zambia, each recruited 6 FSW participants. Peer educator–FSW groups were randomized to 1 of 3 arms: (1) delivery (direct distribution of an oral HIVST from the peer educator), (2) coupon (a coupon for collection of an oral HIVST from a health clinic/pharmacy), or (3) standard-of-care HIV testing. Participants in the 2 HIVST arms received 2 kits: 1 at baseline and 1 at 10 weeks. The primary outcome was any self-reported HIV testing in the past month at the 1- and 4-month visits, as HIVST can replace other types of HIV testing. Secondary outcomes included linkage to care, HIVST use in the HIVST arms, and adverse events. Participants completed questionnaires at 1 and 4 months following peer educator interventions. In all, 965 participants were enrolled between September 16 and October 12, 2016 (delivery, N = 316; coupon, N = 329; standard of care, N = 320); 20% had never tested for HIV. Overall HIV testing at 1 month was 94.9% in the delivery arm, 84.4% in the coupon arm, and 88.5% in the standard-of-care arm (delivery versus standard of care risk ratio [RR] = 1.07, 95% CI 0.99–1.15, P = 0.10; coupon versus standard of care RR = 0.95, 95% CI 0.86–1.05, P = 0.29; delivery versus coupon RR = 1.13, 95% CI 1.04–1.22, P = 0.005). Four-month rates were 84.1% for the delivery arm, 79.8% for the coupon arm, and 75.1% for the standard-of-care arm (delivery versus standard of care RR = 1.11, 95% CI 0.98–1.27, P = 0.11; coupon versus standard of care RR = 1.06, 95% CI 0.92–1.22, P = 0.42; delivery versus coupon RR = 1.05, 95% CI 0.94–1.18, P = 0.40). At 1 month, the majority of HIV tests were self-tests (88.4%). HIV self-test use was higher in the delivery arm compared to the coupon arm (RR = 1.14, 95% CI 1.05–1.23, P = 0.001) at 1 month, but there was no difference at 4 months. Among participants reporting a positive HIV test at 1 (N = 144) and 4 months (N = 235), linkage to care was non-significantly lower in the 2 HIVST arms compared to the standard-of-care arm. There were 4 instances of intimate partner violence related to study participation, 3 of which were related to HIV self-test use. Limitations include the self-reported nature of study outcomes and overall high uptake of HIV testing. Conclusions In this study among FSWs in Zambia, we found that HIVST was acceptable and accessible. However, HIVST may not substantially increase HIV cascade progression in contexts where overall testing and linkage are already high. Trial registration ClinicalTrials.gov NCT02827240 PMID:29161260

Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial

PubMed Central

2012-01-01

Background Systemic Therapy for Advanced or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) is a randomized controlled trial that follows a novel multi-arm, multi-stage (MAMS) design. We describe methodological and practical issues arising with (1) stopping recruitment to research arms following a pre-planned intermediate analysis and (2) adding a new research arm during the trial. Methods STAMPEDE recruits men who have locally advanced or metastatic prostate cancer who are starting standard long-term hormone therapy. Originally there were five research and one control arms, each undergoing a pilot stage (focus: safety, feasibility), three intermediate ‘activity’ stages (focus: failure-free survival), and a final ‘efficacy’ stage (focus: overall survival). Lack-of-sufficient-activity guidelines support the pairwise interim comparisons of each research arm against the control arm; these pre-defined activity cut-off becomes increasingly stringent over the stages. Accrual of further patients continues to the control arm and to those research arms showing activity and an acceptable safety profile. The design facilitates adding new research arms should sufficiently interesting agents emerge. These new arms are compared only to contemporaneously recruited control arm patients using the same intermediate guidelines in a time-delayed manner. The addition of new research arms is subject to adequate recruitment rates to support the overall trial aims. Results (1) Stopping Existing Therapy: After the second intermediate activity analysis, recruitment was discontinued to two research arms for lack-of-sufficient activity. Detailed preparations meant that changes were implemented swiftly at 100 international centers and recruitment continued seamlessly into Activity Stage III with 3 remaining research arms and the control arm. Further regulatory and ethical approvals were not required because this was already included in the initial trial design. (2) Adding New Therapy: An application to add a new research arm was approved by the funder, (who also organized peer review), industrial partner and regulatory and ethical bodies. This was all done in advance of any decision to stop current therapies. Conclusions The STAMPEDE experience shows that recruitment to a MAMS trial and mid-flow changes its design are achievable with good planning. This benefits patients and the scientific community as research treatments are evaluated in a more efficient and cost-effective manner. Trial registration ISRCTN78818544, NCT00268476 First patient into trial: 17 October 2005 First patient into abiraterone comparison: 15 November 2011 PMID:22978443

Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin

PubMed Central

Jensterle Sever, Mojca; Kocjan, Tomaz; Pfeifer, Marija; Kravos, Nika Aleksandra; Janez, Andrej

2014-01-01

Objective The effect of metformin on weight reduction in polycystic ovary syndrome (PCOS) is often unsatisfactory. In this study, we investigated the potential add-on effect of treatment with the glucagon-like peptide-1 receptor agonist liraglutide on weight loss in obese nondiabetic women with PCOS who had lost <5% body weight during pretreatment with metformin. Methods A total of 40 obese women with PCOS, who had been pretreated with metformin for at least 6 months, participated in a 12-week open-label, prospective study. They were randomized to one of three treatment arms: metformin (MET) arm 1000 mg BID, liraglutide (LIRA) arm 1.2 mg QD s.c., or combined MET 1000 mg BID and LIRA (COMBI) 1.2 mg QD s.c. Lifestyle intervention was not actively promoted. The primary outcome was change in body weight. Results Thirty six patients (aged 31.3±7.1 years, BMI 37.1±4.6 kg/m2) completed the study: 14 on MET, 11 on LIRA, and 11 on combined treatment. COMBI therapy was superior to LIRA and MET monotherapy in reducing weight, BMI, and waist circumference. Subjects treated with COMBI lost on average 6.5±2.8 kg compared with a 3.8±3.7 kg loss in the LIRA group and a 1.2±1.4 kg loss in the MET group (P<0.001). The extent of weight loss was stratified: a total of 38% of subjects were high responders who lost ≥5% body weight, 22% of them in the COMBI arm compared with 16 and 0% in the LIRA and MET arm respectively. BMI decreased by 2.4±1.0 in the COMBI arm compared with 1.3±1.3 in LIRA and 0.5±0.5 in the MET arm (P<0.001). Waist circumference also decreased by 5.5±3.8 cm in the COMBI arm compared with 3.2±2.9 cm in LIRA and 1.6±2.9 cm in the MET arm (P=0.029). Subjects treated with liraglutide experienced more nausea than those treated with metformin, but severity of nausea decreased over time and did not correlate with weight loss. Conclusions Short-term combined treatment with liraglutide and metformin was associated with significant weight loss and decrease in waist circumference in obese women with PCOS who had previously been poor responders regarding weight reduction on metformin monotherapy. PMID:24362411

Autofluorescence bronchoscopy with white light bronchoscopy compared with white light bronchoscopy alone for the detection of precancerous lesions: a European randomised controlled multicentre trial

PubMed Central

Haussinger, K; Becker, H; Stanzel, F; Kreuzer, A; Schmidt, B; Strausz, J; Cavaliere, S; Herth, F; Kohlhaufl, M; Muller, K; Huber, R; Pichlmeier, U; Bolliger, C.

2005-01-01

Background: The potential of autofluorescence bronchoscopy (AFB) to detect precancerous lesions in the central airways and its role in lung cancer screening is uncertain. A study was undertaken to evaluate the prevalence of moderate/severe dysplasia (dysplasia II–III) and carcinoma in situ (CIS) using a newly developed AFB system in comparison with conventional white light bronchoscopy (WLB) alone. Methods: In a prospective randomised multicentre trial, smokers ⩾40 years of age (⩾20 pack-years) were stratified into four different risk groups and investigated with either WLB+AFB (arm A) or WLB alone (arm B). Results: 1173 patients (916 men) of mean age 58.7 years were included. Overall (arms A and B), preinvasive lesions (dysplasia II–III and CIS) were detected in 3.9% of the patients. The prevalence of patients with preinvasive lesions in the WLB arm was 2.7% compared with 5.1% in the WLB+AFB arm (p = 0.037). For patients with dysplasia II–III, WLB+AFB increased the detection rate by a factor of 2.1 (p = 0.03), while for CIS the factor was only 1.24 (p = 0.75). The biopsy based sensitivity of WLB alone and WLB+AFB for detecting dysplasia II–III and CIS was 57.9% compared with 82.3% (1.42-fold increase). The corresponding specificity was 62.1% compared with 58.4% (0.94-fold decrease). Conclusions: This first randomised study of AFB showed that the combination of WLB+AFB was significantly superior to WLB alone in detecting preneoplastic lesions. Our findings do not support the general use of AFB as a screening tool for lung cancer, but suggest that it may be of use in certain groups. The precise indications await further study. PMID:15923251

Effect of the Uganda Newborn Study on care-seeking and care practices: a cluster-randomised controlled trial

PubMed Central

Waiswa, Peter; Pariyo, George; Kallander, Karin; Akuze, Joseph; Namazzi, Gertrude; Ekirapa-Kiracho, Elizabeth; Kerber, Kate; Sengendo, Hanifah; Aliganyira, Patrick; Lawn, Joy E.; Peterson, Stefan

2015-01-01

Background Care for women and babies before, during, and after the time of birth is a sensitive measure of the functionality of any health system. Engaging communities in preventing newborn deaths is a promising strategy to achieve further progress in child survival in sub-Saharan Africa. Objective To assess the effect of a home visit strategy combined with health facility strengthening on uptake of newborn care-seeking, practices and services, and to link the results to national policy and scale-up in Uganda. Design The Uganda Newborn Study (UNEST) was a two-arm cluster-randomised controlled trial in rural eastern Uganda. In intervention villages volunteer community health workers (CHWs) were trained to identify pregnant women and make five home visits (two during pregnancy and three in the first week after birth) to offer preventive and promotive care and counselling, with extra visits for sick and small newborns to assess and refer. Health facility strengthening was done in all facilities to improve quality of care. Primary outcomes were coverage of key essential newborn care behaviours (breastfeeding, thermal care, and cord care). Analyses were by intention to treat. This study is registered as a clinical trial, number ISRCTN50321130. Results The intervention significantly improved essential newborn care practices, although many interventions saw major increases in both arms over the study period. Immediate breastfeeding after birth and exclusive breastfeeding were significantly higher in the intervention arm compared to the control arm (72.6% vs. 66.0%; p=0.016 and 81.8% vs. 75.9%, p=0.042, respectively). Skin-to-skin care immediately after birth and cord cutting with a clean instrument were marginally higher in the intervention arm versus the control arm (80.7% vs. 72.2%; p=0.071 and 88.1% vs. 84.4%; p=0.023, respectively). Half (49.6%) of the mothers in the intervention arm waited more than 24 hours to bathe the baby, compared to 35.5% in the control arm (p<0.001). Dry umbilical cord care was also significantly higher in intervention areas (63.9% vs. 53.1%, p<0.001). There was no difference in care-seeking for newborn illness, which was high (around 95%) in both arms. Skilled attendance at delivery increased in both the intervention (by 21%) and control arms (by 19%) between baseline and endline, but there was no significant difference in coverage across arms at endline (79.6% vs. 78.9%; p=0.717). Home visits were pro-poor, with more women in the poorest quintile visited by a CHW compared to families in the least poor quintile, and more women who delivered at home visited by a CHW after birth (73.6%) compared to those who delivered in a hospital or health facility (59.7%) (p<0.001). CHWs visited 62.8% of women and newborns in the first week after birth, with 40.2% receiving a visit on the critical first day of life. Conclusion Consistent with results from other community newborn care studies, volunteer CHWs can be effective in changing long-standing practices around newborn care. The home visit strategy may provide greater benefit to poorer families. However, CHW strategies require strong linkages with and concurrent improvement of quality through health system strengthening, especially in settings with high and increasing demand for facility-based services. PMID:25843498

Impact and Costs of Incentives to Reduce Attrition in Online Trials: Two Randomized Controlled Trials

PubMed Central

Murray, Elizabeth; Kalaitzaki, Eleftheria; White, Ian R; McCambridge, Jim; Thompson, Simon G; Wallace, Paul; Godfrey, Christine

2011-01-01

Background Attrition from follow-up is a major methodological challenge in randomized trials. Incentives are known to improve response rates in cross-sectional postal and online surveys, yet few studies have investigated whether they can reduce attrition from follow-up in online trials, which are particularly vulnerable to low follow-up rates. Objectives Our objective was to determine the impact of incentives on follow-up rates in an online trial. Methods Two randomized controlled trials were embedded in a large online trial of a Web-based intervention to reduce alcohol consumption (the Down Your Drink randomized controlled trial, DYD-RCT). Participants were those in the DYD pilot trial eligible for 3-month follow-up (study 1) and those eligible for 12-month follow-up in the DYD main trial (study 2). Participants in both studies were randomly allocated to receive an offer of an incentive or to receive no offer of an incentive. In study 1, participants in the incentive arm were randomly offered a £5 Amazon.co.uk gift voucher, a £5 charity donation to Cancer Research UK, or entry in a prize draw for £250. In study 2, participants in the incentive arm were offered a £10 Amazon.co.uk gift voucher. The primary outcome was the proportion of participants who completed follow-up questionnaires in the incentive arm(s) compared with the no incentive arm. Results In study 1 (n = 1226), there was no significant difference in response rates between those participants offered an incentive (175/615, 29%) and those with no offer (162/611, 27%) (difference = 2%, 95% confidence interval [CI] –3% to 7%). There was no significant difference in response rates among the three different incentives offered. In study 2 (n = 2591), response rates were 9% higher in the group offered an incentive (476/1296, 37%) than in the group not offered an incentive (364/1295, 28%) (difference = 9%, 95% CI 5% to 12%, P < .001). The incremental cost per extra successful follow-up in the incentive arm was £110 in study 1 and £52 in study 2. Conclusion Whereas an offer of a £10 Amazon.co.uk gift voucher can increase follow-up rates in online trials, an offer of a lower incentive may not. The marginal costs involved require careful consideration. Trial registration ISRCTN31070347; http://www.controlled-trials.com/ISRCTN31070347 (Archived by WebCite at http://www.webcitation.org/5wgr5pl3s) PMID:21371988

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

PubMed Central

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

2008-01-01

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

Improving understanding of clinical trial procedures among low literacy populations: an intervention within a microbicide trial in Malawi

PubMed Central

2012-01-01

Background The intervention reported in this paper was a follow up to an empirical study conducted in Malawi with the aim of assessing trial participants’ understanding of randomisation, double-blinding and placebo use. In the empirical study, the majority of respondents (61.1%; n=124) obtained low scores (lower than 75%) on understanding of all three concepts under study. Based on these findings, an intervention based on a narrative which included all three concepts and their personal implications was designed. The narrative used daily examples from the field of Agriculture because Malawi has an agro-based economy. Methods The intervention was tested using a sample of 36 women who had been identified as low scorers during the empirical study. The 36 low scorers were randomly assigned to control (n=18) and intervention arms (n=18). The control arm went through a session in which they were provided with standard informed consent information for the microbicide trial. The intervention arm went through a session in which they were provided with a narrative in ChiChewa, the local language, with the assistance of a power point presentation which included pictures as well as discussions on justification and personal implications of the concepts under study. Results The findings on the efficacy of the intervention suggest that the 3 scientific concepts and their personal implications can be understood by low literacy populations using simple language and everyday local examples. The findings also suggest that the intervention positively impacted on understanding of trial procedures under study, as 13 of the 18 women in the intervention arm, obtained high scores (above 75%) during the post intervention assessment and none of the 18 in the control arm obtained a high score. Using Fischer’s exact test, it was confirmed that the effect of the intervention on understanding of the three procedures was statistically significant (p=0.0001). Conclusions Potential trial participants can be assisted to understand key clinical trial procedures, their justification and personal implications by using innovative tailored local narratives. PMID:23136958

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

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

Lin, Shinn-Yn; Department of Medical Imaging and Radiological Sciences, College of Medicine, Chang Gung University, Taiwan; Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taiwan

Purpose: This report is the second analysis of a prospective randomized trial to investigate the impact of {sup 18}F-fluorodeoxyglucose positron emission tomography (FDG-PET) on cervical cancer patients with enlarged pelvic lymph nodes identified by magnetic resonance imaging. Methods and Materials: Patients with newly diagnosed cervical cancer with enlarged pelvic lymph nodes but free of enlarged para-aortic lymph nodes (PALN) were eligible. Patients were randomized to receive either pretreatment FDG-PET (PET arm) or not (control arm). The whole pelvis was the standard irradiation field for all patients except those with FDG-avid extrapelvic findings. Results: In all, 129 patients were enrolled. Pretreatmentmore » PET detected extrapelvic metastases in 7 patients. No new patient experienced treatment failure during the additional 4-year follow-up period. There were no significant differences between the PET arm and the control arm regarding overall survival, disease-free survival, and freedom from extrapelvic metastasis. In the control arm, 8 of 10 patients with PALN relapse had limited extrapelvic nodal failures; their 5-year disease-specific survival was 34.3%. By contrast, only 1 of 5 patients with PALN relapse in the PET arm experienced such limited failures; their 5-year survival rate was 0%. Conclusions: Although the pretreatment detection of PALN did not translate into survival benefit, it indeed decreased the need for extended-field concurrent chemoradiation therapy.« less

Randomized Clinical Trial of Weekly vs. Triweekly Cisplatin-Based Chemotherapy Concurrent With Radiotherapy in the Treatment of Locally Advanced Cervical Cancer

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

Ryu, Sang-Young, E-mail: ryu@kcch.re.kr; Lee, Won-Moo; Kim, Kidong

Purpose: To compare compliance, toxicity, and outcome of weekly and triweekly cisplatin administration concurrent with radiotherapy in locally advanced cervical cancer. Methods and Materials: In this open-label, randomized trial, 104 patients with histologically proven Stage IIB-IVA cervical cancer were randomly assigned by a computer-generated procedure to weekly (weekly cisplatin 40 mg/m{sup 2}, six cycles) and triweekly (cisplatin 75 mg/m{sup 2} every 3 weeks, three cycles) chemotherapy arms during concurrent radiotherapy. The difference of compliance and the toxicity profiles between the two arms were investigated, and the overall survival rate was analyzed after 5 years. Results: All patients tolerated both treatmentsmore » very well, with a high completion rate of scheduled chemotherapy cycles. There was no statistically significant difference in compliance between the two arms (86.3% in the weekly arm, 92.5% in the triweekly arm, p > 0.05). Grade 3-4 neutropenia was more frequent in the weekly arm (39.2%) than in the triweekly arm (22.6%) (p = 0.03). The overall 5-year survival rate was significantly higher in the triweekly arm (88.7%) than in the weekly arm (66.5%) (hazard ratio 0.375; 95% confidence interval 0.154-0.914; p = 0.03). Conclusions: Triweekly cisplatin 75-mg/m{sup 2} chemotherapy concurrent with radiotherapy is more effective and feasible than the conventional weekly cisplatin 40-mg/m{sup 2} regimen and may be a strong candidate for the optimal cisplatin dose and dosing schedule in the treatment of locally advanced cervical cancer.« less

Does reducing spasticity translate into functional benefit? An exploratory meta-analysis

PubMed Central

Francis, H; Wade, D; Turner-Stokes, L; Kingswell, R; Dott, C; Coxon, E

2004-01-01

Background: Spasticity and loss of function in an affected arm are common after stroke. Although botulinum toxin is used to reduce spasticity, its functional benefits are less easily demonstrated. This paper reports an exploratory meta-analysis to investigate the relationship between reduced arm spasticity and improved arm function. Method: Individual data from stroke patients in two randomised controlled trials of intra-muscular botulinum toxin were pooled. The Modified Ashworth Scale (elbow, wrist, fingers) was used to calculate a "Composite Spasticity Index". Data from the arm section of the Barthel Activities of Daily Living Index (dressing, grooming, and feeding) and three subjective measures (putting arm through sleeve, cleaning palm, cutting fingernails) were summed to give a "Composite Functional Index". Change scores and the time of maximum change were also calculated. Results: Maximum changes in both composite measures occurred concurrently in 47 patients. In 26 patients the improvement in spasticity preceded the improvement in function with 18 showing the reverse. There was a definite relationship between the maximum change in spasticity and the maximum change in arm function, independent of treatment (ρ = –0.2822, p = 0.0008, n = 137). There was a clear relationship between the changes in spasticity and in arm function in patients treated with botulinum toxin (Dysport) at 500 or 1000 units (ρ = –0.5679, p = 0.0090, n = 22; ρ = –0.4430, p = 0.0018, n = 47), but not in those treated with placebo or 1500 units. Conclusions: Using a targeted meta-analytic approach, it is possible to demonstrate that reducing spasticity in the arm is associated with a significant improvement in arm function. PMID:15489384

[Current state and prospects of military personnel health monitoring].

PubMed

Rezvantsev, M V; Kuznetsov, S M; Ivanov, V V; Zakurdaev, V V

2014-01-01

The current article is dedicated to some features of the Russian Federation Armed Forces military personnel health monitoring such as legal and informational provision, methodological basis of functioning, historical aspect of formation and development of the social and hygienic monitoring in the Russian Federation Armed Forces. The term "military personnel health monitoring" is defined as an analytical system of constant and long-term observation, analysis, assessment, studying of factors determined the military personnel health, these factors correlations, health risk factors management in order to minimize them. The current state of the military personnel health monitoring allows coming to the conclusion that the military health system does have forces and resources for state policy of establishing the population health monitoring system implementation. The following directions of the militarily personnel health monitoring improvement are proposed: the Russian Federation Armed Forces medical service record and report system reorganization bringing it closer to the civilian one, implementation of the integrated approach to the medical service informatisation, namely, military personnel health status and medical service resources monitoring. The leading means in this direction are development and introduction of a military serviceman individual health status monitoring system on the basis of a serviceman electronic medical record card. Also it is proposed the current Russian Federation Armed Forces social and hygienic monitoring improvement at the expense of informational interaction between the two subsystems on the basis of unified military medical service space.

Changes of heart rate variability and prefrontal oxygenation during Tai Chi practice versus arm ergometer cycling.

PubMed

Lu, Xi; Hui-Chan, Christina Wan-Ying; Tsang, William Wai-Nam

2016-11-01

[Purpose] Exercise has been shown to improve cardiovascular fitness and cognitive function. Whether the inclusion of mind over exercise would increase parasympathetic control of the heart and brain activities more than general exercise at a similar intensity is not known. The aim of this study was to compare the effects of Tai Chi (mind-body exercise) versus arm ergometer cycling (body-focused exercise) on the heart rate variability and prefrontal oxygenation level. [Subjects and Methods] A Tai Chi master was invited to perform Tai Chi and arm ergometer cycling with similar exercise intensity on two separate days. Heart rate variability and prefrontal oxyhemoglobin levels were measured continuously by a RR recorder and near-infrared spectroscopy, respectively. [Results] During Tai Chi exercise, spectral analysis of heart rate variability demonstrated a higher high-frequency power as well as a lower low-frequency/high-frequency ratio than during ergometer cycling, suggesting increased parasympathetic and decreased sympathetic control of the heart. Also, prefrontal oxyhemoglobin and total hemoglobin levels were higher than those during arm ergometer exercise. [Conclusion] These findings suggest that increased parasympathetic control of the heart and prefrontal activities may be associated with Tai Chi practice. Having a "mind" component in Tai Chi could be more beneficial for older adults' cardiac health and cognitive function than body-focused ergometer cycling.

Prevention and treatment of exercise related leg pain in young soldiers; a review of the literature and current practice in the Dutch Armed Forces.

PubMed

Zimmermann, Wes O; Helmhout, P H; Beutler, A

2017-04-01

Overuse injuries of the leg are a common problem for young soldiers. This article reviews the literature concerning the prevention and treatment of exercise related leg pain in military settings and presents the latest developments in proposed mechanisms and treatments. Current practice and treatment protocols from the Dutch Armed Forces are reviewed, with an emphasis on the most prevalent conditions of medial tibial stress syndrome and chronic exertional compartment syndrome. The conclusion is that exercise related leg pain in the military is an occupational problem that deserves further study. 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/.

Efficacy Endpoints of Radiation Therapy Group Protocol 0247: A Randomized, Phase 2 Study of Neoadjuvant Radiation Therapy Plus Concurrent Capecitabine and Irinotecan or Capecitabine and Oxaliplatin for Patients With Locally Advanced Rectal Cancer

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

Wong, Stuart J.; Moughan, Jennifer; Meropol, Neal J., E-mail: Neal.Meropol@case.edu

Purpose: To report secondary efficacy endpoints of Radiation Therapy Oncology Group protocol 0247, primary endpoint analysis of which demonstrated that preoperative radiation therapy (RT) with capecitabine plus oxaliplatin achieved a pathologic complete remission prespecified threshold (21%) to merit further study, whereas RT with capecitabine plus irinotecan did not (10%). Methods and Materials: A randomized, phase 2 trial evaluated preoperative RT (50.4 Gy in 1.8-Gy fractions) with 2 concurrent chemotherapy regimens: (1) capecitabine (1200 mg/m{sup 2}/d Monday-Friday) plus irinotecan (50 mg/m{sup 2}/wk × 4); and (2) capecitabine (1650 mg/m{sup 2}/d Monday-Friday) plus oxaliplatin (50 mg/m{sup 2}/wk × 5) for clinical T3 or T4 rectal cancer. Surgery was performed 4 tomore » 8 weeks after chemoradiation, then 4 to 6 weeks later, adjuvant chemotherapy (oxaliplatin 85 mg/m{sup 2}; leucovorin 400 mg/m{sup 2}; 5-fluorouracil 400 mg/m{sup 2}; 5-fluorouracil 2400 mg/m{sup 2}) every 2 weeks × 9. Disease-free survival (DFS) and overall survival (OS) were estimated univariately by the Kaplan-Meier method. Local–regional failure (LRF), distant failure (DF), and second primary failure (SP) were estimated by the cumulative incidence method. No statistical comparisons were made between arms because each was evaluated individually. Results: A total of 104 patients (median age, 57 years) were treated; characteristics were similar for both arms. Median follow-up for RT with capecitabine/irinotecan arm was 3.77 years and for RT with capecitabine/oxaliplatin arm was 3.97 years. Four-year DFS, OS, LRF, DF, and SP estimates for capecitabine/irinotecan arm were 68%, 85%, 16%, 24%, and 2%, respectively. The 4-year DFS, OS, LRF, DF, and SP failure estimates for capecitabine/oxaliplatin arm were 62%, 75%, 18%, 30%, and 6%, respectively. Conclusions: Efficacy results for both arms are similar to other reported studies but suggest that pathologic complete remission is an unsuitable surrogate for traditional survival metrics of clinical outcome. Although it remains uncertain whether the addition of a second cytotoxic agent enhances the effectiveness of fluorouracil plus RT, these results suggest that further study of irinotecan may be warranted.« less

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.

Vitamin D and calcium supplementation for three years in postmenopausal osteoporosis significantly alters bone mineral and organic matrix quality.

PubMed

Paschalis, E P; Gamsjaeger, S; Hassler, N; Fahrleitner-Pammer, A; Dobnig, H; Stepan, J J; Pavo, I; Eriksen, E F; Klaushofer, K

2017-02-01

Prospective, controlled clinical trials in postmenopausal osteoporosis typically compare effects of an active drug with placebo in addition to vitamin D and calcium supplementation in both treatment arms. While clinical benefits are documented, the effect of this supplementation in the placebo arm and in clinical practice on bone material composition properties is unknown. The purpose of the present study was to evaluate these bone quality indices (specifically mineral/matrix, nanoporosity, glycosaminoglycan content, mineral maturity/crystallinity, and pyridinoline content) in patients that either received long-term vitamin D (400-1200IU) and calcium (1.0-1.5g) supplementation, or did not. We have analyzed by Raman microspectroscopy the bone forming trabecular surfaces of iliac crest in pre-treatment samples of a teriparatide study and the endpoint biopsies of the control arm obtained from the HORIZON trial. In general, the mineral/matrix ratio and the glycosaminoglycan (GAG) content was higher while nanoporosity, (a surrogate for tissue water content), the mineral maturity/crystallinity (MMC) and the pyridinoline (Pyd) content was lower in patients without long-term supplementation. Moreover, all indices were significantly dependent on tissue age. In conclusion, vitamin D and calcium supplementation is associated with altered mineral and organic matrix properties. Copyright © 2016 Elsevier Inc. All rights reserved.

Use of manual alveolar recruitment maneuvers to eliminate atelectasis artifacts identified during thoracic computed tomography of healthy neonatal foals.

PubMed

Lascola, Kara M; Clark-Price, Stuart C; Joslyn, Stephen K; Mitchell, Mark A; O'Brien, Robert T; Hartman, Susan K; Kline, Kevin H

2016-11-01

OBJECTIVE To evaluate use of single manual alveolar recruitment maneuvers (ARMs) to eliminate atelectasis during CT of anesthetized foals. ANIMALS 6 neonatal Standardbred foals. PROCEDURES Thoracic CT was performed on spontaneously breathing anesthetized foals positioned in sternal (n = 3) or dorsal (3) recumbency when foals were 24 to 36 hours old (time 1), 4 days old (time 2), 7 days old (time 3), and 10 days old (time 4). The CT images were collected without ARMs (all times) and during ARMs with an internal airway pressure of 10, 20, and 30 cm H 2 O (times 2 and 3). Quantitative analysis of CT images measured whole lung and regional changes in attenuation or volume with ARMs. RESULTS Increased attenuation and an alveolar pattern were most prominent in the dependent portion of the lungs. Subjectively, ARMs did not eliminate atelectasis; however, they did incrementally reduce attenuation, particularly in the nondependent portion of the lungs. Quantitative differences in lung attenuation attributable to position of foal were not identified. Lung attenuation decreased significantly (times 2 and 3) and lung volume increased significantly (times 2 and 3) after ARMs. Changes in attenuation and volume were most pronounced in the nondependent portion of the lungs and at ARMs of 20 and 30 cm H 2 O. CONCLUSIONS AND CLINICAL RELEVANCE Manual ARMs did not eliminate atelectasis but reduced attenuation in nondependent portions of the lungs. Positioning of foals in dorsal recumbency for CT may be appropriate when pathological changes in the ventral portion of the lungs are suspected.

Superior Patency of Upper Arm Arteriovenous Fistulae in High Risk Patients

PubMed Central

Chiulli, Larissa C; Vasilas, Penny; Dardik, Alan

2011-01-01

Background Despite an increased propensity to primary failure in forearm arteriovenous fistulae compared to upper arm fistulae, forearm fistulae remain the preferred primary access type for chronic hemodialysis patients. In a high risk patient population with multiple medical comorbidities associated with requirement for intravenous access we compared the rates of access failure in forearm and upper arm fistulae. Materials and Methods The records of all patients having primary native arteriovenous fistulae placed between 2004 and 2009 at the VA Connecticut Healthcare system were reviewed (n=118). Primary and secondary patency of upper arm and forearm fistulae were evaluated using Kaplan-Meier survival analysis. The effects of medical comorbidities on access patency were analyzed with Cox regression. Results The median time to primary failure of the vascular access was 0.288 years in the forearm group compared to 0.940 years in the upper arm group (p=0.028). Secondary patency was 52% at 4.9 years in upper arm fistulae compared to 52% at 1.1 years in the forearm group (p=0.036). There was no significant effect of patient comorbidities on fistula failure; however, there was a trend toward upper arm surgical site as a protective factor for primary fistula patency (Hazard Ratio=0.573, p=0.076). Conclusions In veterans needing hemodialysis, a high risk population with extensive comorbid factors often requiring intravascular access, upper arm fistulae are not only a viable option for primary vascular access, but are likely to be a superior option to classic forearm fistulae. PMID:21571318

Dynamic balance control in elders: gait initiation assessment as a screening tool

NASA Technical Reports Server (NTRS)

Chang, H.; Krebs, D. E.; Wall, C. C. (Principal Investigator)

1999-01-01

OBJECTIVE: To determine whether measurements of center of gravity-center of pressure separation (CG-CP moment arm) during gait initiation can differentiate healthy from disabled subjects with sufficient specificity and sensitivity to be useful as a screening test for dynamic balance in elderly patients. SUBJECTS: Three groups of elderly subjects (age, 74.97+/-6.56 yrs): healthy elders (HE, n = 21), disabled elders (DE, n = 20), and elders with vestibular hypofunction (VH, n = 18). DESIGN: Cross-sectional, intact-groups research design. Peak CG-CP moment arm measures how far the subject will tolerate the whole-body CG to deviate from the ground reaction force's CP; it represents dynamic balance control. Screening test cutoff points at 16 to 18 cm peak CG-CP moment arm predicted group membership. RESULTS: The magnitude of peak CG-CP moment arm was significantly greater in HE than in DE and VH subjects (p<.01) and was not different between the DE and VH groups. The peak CG-CP moment arm occurred at the end of single stance phase in all groups. As a screening test, the peak moment arm has greater than 50% sensitivity and specificity to discriminate the HE group from the DE and VH groups with peak CG-CP moment arm cutoff points between 16 and 18 cm. CONCLUSIONS: Examining dynamic balance through the use of the CG-CP moment arm during single stance in gait initiation discriminates between nondisabled and disabled older persons and warrants further investigation as a potential tool to identify people with balance dysfunction.

Success of nutrition-therapy interventions in persons with type 2 diabetes: challenges and future directions.

PubMed

Franz, Marion J; MacLeod, Janice

2018-01-01

A systematic review was conducted by the Academy of Nutrition and Dietetics to determine the evidence for the effectiveness of individualized nutrition therapy provided by a dietitian nutritionist and evidence-based (EB) nutrition-therapy interventions in adults with diabetes. This article briefly reviews the systematic process used and summarizes the effectiveness evidence and intervention recommendations. In persons with type 2 diabetes (T2D), 18 studies met study criteria for the effectiveness question. A 0.3%-2.0% decrease from baseline in glycated hemoglobin was reported at 3 months in 13 study arms, a 0.3%-1.8% decrease at 6 months in 12 study arms, a 0.3%-1.6% decrease at 12 months with ongoing support in six study arms, and a 0.6%-1.8% decrease at >12 months in four study arms. An initial series of encounters with follow-up visits and implementation of a variety of nutrition-therapy interventions, all of which reduced energy intake, were reported. Nutrition therapy also significantly decreased doses or number of glucose-lowering medications used and resulted in improvements in quality of life. Mixed effects on cardiovascular risk factors and body weight were reported. Fourteen questions were identified related to nutrition-therapy interventions. A total of 38 studies met study criteria for the nutrition-intervention questions, from which 30 conclusion statements and 19 nutrition-practice guideline recommendations for T2D were written. Three additional NPG recommendations for T2D were written based on evidence reviewed by the American Diabetes Association. The 22 nutrition-intervention recommendations for T2D are summarized. How to implement nutrition-practice guideline recommendations effectively by health care providers and individuals with T2D remains challenging. Of importance, it is recognized that identifying and integrating EB digital health-technology tools into clinical practice are major challenges for future management of diabetes, self-management education, and support.

Results of Clinicians Using a Therapeutic Robotic System in an Inpatient Stroke Rehabilitation Unit

PubMed Central

2011-01-01

Background Physical rehabilitation is an area where robotics could contribute significantly to improved motor return for individuals following a stroke. This paper presents the results of a preliminary randomized controlled trial (RCT) of a robot system used in the rehabilitation of the paretic arm following a stroke. Methods The study's objectives were to explore the efficacy of this new type of robotic therapy as compared to standard physiotherapy treatment in treating the post-stroke arm; to evaluate client satisfaction with the proposed robotic system; and to provide data for sample size calculations for a proposed larger multicenter RCT. Twenty clients admitted to an inpatient stroke rehabilitation unit were randomly allocated to one of two groups, an experimental (robotic arm therapy) group or a control group (conventional therapy). An occupational therapist blinded to patient allocation administered two reliable measures, the Chedoke Arm and Hand Activity Inventory (CAHAI-7) and the Chedoke McMaster Stroke Assessment of the Arm and Hand (CMSA) at admission and discharge. For both groups, at admission, the CMSA motor impairment stage of the affected arm was between 1 and 3. Results Data were compared to determine the effectiveness of robot-assisted versus conventional therapy treatments. At the functional level, both groups performed well, with improvement in scores on the CAHAI-7 showing clinical and statistical significance. The CAHAI-7 (range7-49) is a measure of motor performance using functional items. Individuals in the robotic therapy group, on average, improved by 62% (95% CI: 26% to 107%) while those in the conventional therapy group changed by 30% (95% CI: 4% to 61%). Although performance on this measure is influenced by hand recovery, our results showed that both groups had similar stages of motor impairment in the hand. Furthermore, the degree of shoulder pain, as measured by the CMSA pain inventory scale, did not worsen for either group over the course of treatment. Conclusion Our findings indicated that robotic arm therapy alone, without additional physical therapy interventions tailored to the paretic arm, was as effective as standard physiotherapy treatment for all responses and more effective than conventional treatment for the CMSA Arm (p = 0.04) and Hand (p = 0.04). At the functional level, both groups performed equally well. PMID:21871095

Text Messaging for Exercise Promotion in Older Adults From an Upper-Middle-Income Country: Randomized Controlled Trial

PubMed Central

Khoo, Selina; Morris, Tony

2016-01-01

Background Mobile technology to promote exercise is effective; however, most evidence is from studies of younger groups in high-income countries. Investigating if short message service (SMS) texting can affect exercise participation in older adults from an upper-middle-income country is important considering the proliferation of mobile phones in developing regions and the increased interest of older adults in using mobile phones. Objective The main objective was to examine the short- and long-term effects of SMS text messaging on exercise frequency in older adults. Secondary objectives were to investigate how SMS text messages impact study participants’ exercise frequency and the effects of the intervention on secondary outcomes. Methods The Malaysian Physical Activity for Health Study (myPAtHS) was a 24-week, 2-arm, parallel randomized controlled trial conducted in urban Malaysia. Participants were recruited via health talks in resident associations and religious facilities. Older Malaysians (aged 55-70 years) who used mobile phones and did not exercise regularly were eligible to participate in the study. Participants randomly allocated to the SMS texting arm received an exercise booklet and 5 weekly SMS text messages over 12 weeks. The content of the SMS text messages was derived from effective behavior change techniques. The non-SMS texting arm participants received only the exercise booklet. Home visits were conducted to collect outcome data: (1) exercise frequency at 12 and 24 weeks, (2) secondary outcome data (exercise self-efficacy, physical activity–related energy expenditure, sitting time, body mass index, grip and leg strength) at baseline and at 12 and 24 weeks. Intention-to-treat procedures were applied for data analysis. Semistructured interviews focusing primarily on the SMS text messages and their impact on exercise frequency were conducted at weeks 12 and 24. Results In total, 43 participants were randomized into the SMS texting arm (n=22) and the non-SMS texting arm (n=21). Study-unrelated injuries forced 4 participants to discontinue after a few weeks (they were not included in any analyses). Overall retention was 86% (37/43). After 12 weeks, SMS texting arm participants exercised significantly more than non-SMS texting arm participants (mean difference 1.21 times, bias-corrected and accelerated bootstrap [BCa] 95% CI 0.18-2.24). Interview analysis revealed that the SMS text messages positively influenced SMS texting arm participants who experienced exercise barriers. They described the SMS text messages as being encouraging, a push, and a reminder. After 24 weeks, there was no significant difference between the research arms (mean difference 0.74, BCa 95% CI –0.30 to 1.76). There were no significant effects for secondary outcomes. Conclusions This study provides evidence that SMS text messaging is effective in promoting exercise in older adults from an upper-middle-income country. Although the effects were not maintained when SMS text messaging ceased, the results are promising and warrant more research on behavioral mobile health interventions in other regions. Trial Registration Clinicaltrials.gov NCT02123342; http://clinicaltrials.gov/ct2/show/NCT02123342 (Archived by WebCite at http://www.webcitation.org/6eGSsu2EI). PMID:26742999

“Gunslinger’s gait”: a new cause of unilaterally reduced arm swing

PubMed Central

Araújo, Rui; Ferreira, Joaquim J; Antonini, Angelo

2015-01-01

Objective To postulate a new possible cause of a unilaterally reduced arm swing in addition to the known medical conditions such as shoulder pathology, Erb’s palsy, stroke, and Parkinson’s disease. Methods Analysis of YouTube videos depicting the gait of highly ranked Russian officials. Results We found a similar walking pattern in President Vladimir Putin, Prime Minister Dmitry Medvedev and three other highly ranked Russian officials, all presenting with a consistently reduced right arm swing in the absence of other overt neurological abnormalities. Conclusions We propose that this new gait pattern, which we term “gunslinger’s gait,” may result from a behavioural adaptation, possibly triggered by KGB or other forms of weapons training where trainees are taught to keep their right hand close to the chest while walking, allowing them to quickly draw a gun when faced with a foe. This should be included in the differential diagnosis of a unilaterally reduced arm swing. PMID:26666758

Changes in Hospital Competitive Strategy: A New Medical Arms Race?

PubMed Central

Devers, Kelly J; Brewster, Linda R; Casalino, Lawrence P

2003-01-01

Objective To describe changes in hospitals' competitive strategies, specifically the relative emphasis placed on strategies for competing along price and nonprice (i.e., service, amenities, perceived quality) dimensions, and the reasons for any observed shifts. Methods This study uses data gathered through the Community Tracking Study site visits, a longitudinal study of a nationally representative sample of 12 U.S. communities. Research teams visited each of these communities every two years since 1996 and conducted between 50 to 90 semistructured interviews. Additional information on hospital competition and strategy was gathered from secondary data. Principal Findings We found that hospitals' strategic emphasis changed significantly between 1996–1997 and 2000–2001. In the mid-1990s, hospitals primarily competed on price through “wholesale” strategies (i.e., providing services attractive to managed care plans). By 2000–2001, nonprice competition was becoming increasingly important and hospitals were reviving “retail” strategies (i.e., providing services attractive to individual physicians and the patients they serve). Three major factors explain this shift in hospital strategy: less than anticipated selective contracting and capitated payment; the freeing up of hospital resources previously devoted to horizontal and vertical integration strategies; and, the emergence and growth of new competitors. Conclusion Renewed emphasis on nonprice competition and retail strategies, and the service mimicking and one-upmanship that result, suggest that a new medical arms race is emerging. However, there are important differences between the medical arms race today and the one that occurred in the 1970s and early 1980s: the hospital market is more concentrated and price competition remains relatively important. The development of a new medical arms race has significant research and policy implications. PMID:12650375

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

Effects of intensive arm training with the rehabilitation robot ARMin II in chronic stroke patients: four single-cases

PubMed Central

2009-01-01

Background Robot-assisted therapy offers a promising approach to neurorehabilitation, particularly for severely to moderately impaired stroke patients. The objective of this study was to investigate the effects of intensive arm training on motor performance in four chronic stroke patients using the robot ARMin II. Methods ARMin II is an exoskeleton robot with six degrees of freedom (DOF) moving shoulder, elbow and wrist joints. Four volunteers with chronic (≥ 12 months post-stroke) left side hemi-paresis and different levels of motor severity were enrolled in the study. They received robot-assisted therapy over a period of eight weeks, three to four therapy sessions per week, each session of one hour. Patients 1 and 4 had four one-hour training sessions per week and patients 2 and 3 had three one-hour training sessions per week. Primary outcome variable was the Fugl-Meyer Score of the upper extremity Assessment (FMA), secondary outcomes were the Wolf Motor Function Test (WMFT), the Catherine Bergego Scale (CBS), the Maximal Voluntary Torques (MVTs) and a questionnaire about ADL-tasks, progress, changes, motivation etc. Results Three out of four patients showed significant improvements (p < 0.05) in the main outcome. The improvements in the FMA scores were aligned with the objective results of MVTs. Most improvements were maintained or even increased from discharge to the six-month follow-up. Conclusion Data clearly indicate that intensive arm therapy with the robot ARMin II can significantly improve motor function of the paretic arm in some stroke patients, even those in a chronic state. The findings of the study provide a basis for a subsequent controlled randomized clinical trial. PMID:20017939

Trastuzumab Emtansine With or Without Pertuzumab Versus Trastuzumab Plus Taxane for Human Epidermal Growth Factor Receptor 2-Positive, Advanced Breast Cancer: Primary Results From the Phase III MARIANNE Study.

PubMed

Perez, Edith A; Barrios, Carlos; Eiermann, Wolfgang; Toi, Masakazu; Im, Young-Hyuck; Conte, Pierfranco; Martin, Miguel; Pienkowski, Tadeusz; Pivot, Xavier; Burris, Howard; Petersen, Jennifer A; Stanzel, Sven; Strasak, Alexander; Patre, Monika; Ellis, Paul

2017-01-10

Purpose Trastuzumab and pertuzumab are human epidermal growth factor receptor 2 (HER2) -targeted monoclonal antibodies, and trastuzumab emtansine (T-DM1) is an antibody-drug conjugate that combines the properties of trastuzumab with the cytotoxic activity of DM1. T-DM1 demonstrated encouraging efficacy and safety in a phase II study of patients with previously untreated HER2-positive metastatic breast cancer. Combination T-DM1 and pertuzumab showed synergistic activity in cell culture models and had an acceptable safety profile in a phase Ib and II study. Methods In the MARIANNE study, 1,095 patients with centrally assessed, HER2-positive, advanced breast cancer and no prior therapy for advanced disease were randomly assigned 1:1:1 to control (trastuzumab plus taxane), T-DM1 plus placebo, hereafter T-DM1, or T-DM1 plus pertuzumab at standard doses. Primary end point was progression-free survival (PFS), as assessed by independent review. Results T-DM1 and T-DM1 plus pertuzumab showed noninferior PFS compared with trastuzumab plus taxane (median PFS: 13.7 months with trastuzumab plus taxane, 14.1 months with T-DM1, and 15.2 months with T-DM1 plus pertuzumab). Neither experimental arm showed PFS superiority to trastuzumab plus taxane. Response rate was 67.9% in patients who were treated with trastuzumab plus taxane, 59.7% with T-DM1, and 64.2% with T-DM1 plus pertuzumab; median response duration was 12.5 months, 20.7 months, and 21.2 months, respectively. The incidence of grade ≥ 3 adverse events was numerically higher in the control arm (54.1%) versus the T-DM1 arm (45.4%) and T-DM1 plus pertuzumab arm (46.2%). Numerically fewer patients discontinued treatment because of adverse events in the T-DM1 arms, and health-related quality of life was maintained for longer in the T-DM1 arms. Conclusion T-DM1 showed noninferior, but not superior, efficacy and better tolerability than did taxane plus trastuzumab for first-line treatment of HER2-positive, advanced breast cancer.

Trastuzumab Emtansine With or Without Pertuzumab Versus Trastuzumab Plus Taxane for Human Epidermal Growth Factor Receptor 2–Positive, Advanced Breast Cancer: Primary Results From the Phase III MARIANNE Study

PubMed Central

Perez, Edith A.; Barrios, Carlos; Eiermann, Wolfgang; Toi, Masakazu; Im, Young-Hyuck; Conte, Pierfranco; Martin, Miguel; Pienkowski, Tadeusz; Pivot, Xavier; Burris, Howard; Petersen, Jennifer A.; Stanzel, Sven; Strasak, Alexander; Patre, Monika; Ellis, Paul

2017-01-01

Purpose Trastuzumab and pertuzumab are human epidermal growth factor receptor 2 (HER2) –targeted monoclonal antibodies, and trastuzumab emtansine (T-DM1) is an antibody–drug conjugate that combines the properties of trastuzumab with the cytotoxic activity of DM1. T-DM1 demonstrated encouraging efficacy and safety in a phase II study of patients with previously untreated HER2-positive metastatic breast cancer. Combination T-DM1 and pertuzumab showed synergistic activity in cell culture models and had an acceptable safety profile in a phase Ib and II study. Methods In the MARIANNE study, 1,095 patients with centrally assessed, HER2-positive, advanced breast cancer and no prior therapy for advanced disease were randomly assigned 1:1:1 to control (trastuzumab plus taxane), T-DM1 plus placebo, hereafter T-DM1, or T-DM1 plus pertuzumab at standard doses. Primary end point was progression-free survival (PFS), as assessed by independent review. Results T-DM1 and T-DM1 plus pertuzumab showed noninferior PFS compared with trastuzumab plus taxane (median PFS: 13.7 months with trastuzumab plus taxane, 14.1 months with T-DM1, and 15.2 months with T-DM1 plus pertuzumab). Neither experimental arm showed PFS superiority to trastuzumab plus taxane. Response rate was 67.9% in patients who were treated with trastuzumab plus taxane, 59.7% with T-DM1, and 64.2% with T-DM1 plus pertuzumab; median response duration was 12.5 months, 20.7 months, and 21.2 months, respectively. The incidence of grade ≥ 3 adverse events was numerically higher in the control arm (54.1%) versus the T-DM1 arm (45.4%) and T-DM1 plus pertuzumab arm (46.2%). Numerically fewer patients discontinued treatment because of adverse events in the T-DM1 arms, and health-related quality of life was maintained for longer in the T-DM1 arms. Conclusion T-DM1 showed noninferior, but not superior, efficacy and better tolerability than did taxane plus trastuzumab for first-line treatment of HER2-positive, advanced breast cancer. PMID:28056202

Mental health consequences of overstretch in the UK armed forces: first phase of a cohort study

PubMed Central

Fear, Nicola T; Hull, Lisa; Greenberg, Neil; Earnshaw, Mark; Hotopf, Matthew; Wessely, Simon

2007-01-01

Objective To assess the relation between frequency and duration of deployment of UK armed forces personnel on mental health. Design First phase of a cohort study. Setting UK armed forces personnel. Participants Operational history in past three years of a randomly chosen stratified sample of 5547 regulars with experience of deployment. Main outcome measures Psychological distress (general health questionnaire-12), caseness for post-traumatic stress disorder, physical symptoms, and alcohol use (alcohol use disorders identification test). Results Personnel who were deployed for 13 months or more in the past three years were more likely to fulfil the criteria for post-traumatic stress disorder (odds ratio 1.55, 95% confidence interval 1.07 to 2.32), show caseness on the general health questionnaire (1.35, 1.10 to 1.63), and have multiple physical symptoms (1.49, 1.19 to 1.87). A significant association was found between duration of deployment and severe alcohol problems. Exposure to combat partly accounted for these associations. The associations between number of deployments in the past three years and mental disorders were less consistent than those related to duration of deployment. Post-traumatic stress disorder was also associated with a mismatch between expectations about the duration of deployment and the reality. Conclusions A clear and explicit policy on the duration of each deployment of armed forces personnel may reduce the risk of post-traumatic stress disorder. An association was found between deployment for more than a year in the past three years and mental health that might be explained by exposure to combat. PMID:17664192

Effect of a nurse-led psychoeducational intervention on healthcare service utilization among adults with advanced cancer

PubMed Central

Martinez, Kathryn A.; Friese, Christopher; Kershaw, Trace; Given, Charles W.; Fendrick, A. Mark; Northouse, Laurel

2015-01-01

Purpose/Objectives To examine differences in healthcare service utilization among patients with advanced cancer participating in a nurse-led psychoeducational intervention. Design Secondary analysis of trial data. Setting Four Michigan cancer centers. Sample 484 patients with advanced cancer. Methods Patients were randomized to three groups: brief intervention, extensive intervention, or control. Medical chart review took place at baseline, three months, and six months to measure patients’ healthcare service utilization, defined as emergency department (ED) visits or inpatient hospitalizations. Multivariable logistic regression was used to examine the odds, by study arm, of visiting the ED and being hospitalized, controlling for patient sociodemographic and health status factors, as well as baseline health-related quality of life (QOL). Main Research Variables Study arm (brief, extensive, or control), ED visitation (one or more times versus none), inpatient hospitalizations (one or more times versus none), and covariates. Findings No significant differences in ED visits or inpatient hospitalizations were observed among study arms. ED visits were more frequent for patients with lung or colorectal cancer, more comorbidities, and lower baseline QOL. Baseline QOL was associated with inpatient hospitalizations in the adjusted analysis. Conclusions The psychoeducational intervention, either in brief or extensive format, is unlikely to increase healthcare service utilization. Implications for Nursing Efficacious nurse-led psychoeducational interventions to improve QOL do not place undue burdens on the healthcare system and may improve care. PMID:26148327

Patterns of herpes simplex virus shedding over 1 month and the impact of acyclovir and HIV in HSV-2-seropositive women in Tanzania

PubMed Central

Weiss, Helen A; LeGoff, Jerome; Changalucha, John; Clayton, Tim C; Ross, David A; Belec, Laurent; Hayes, Richard J; Watson-Jones, Deborah

2011-01-01

Objectives Few studies have examined the frequency and duration of genital herpes simplex virus (HSV) shedding in sub-Saharan Africa. This study describes HSV shedding patterns among a sample of HSV-2-seropositive women enrolled in a placebo-controlled trial of HSV suppressive therapy (acyclovir 400 mg twice a day) in Tanzania. Methods Trial participants were invited to participate in a substudy involving 12 clinic visits over 4 weeks. At each visit, cervical, vaginal and external skin swabs were taken and analysed for HSV DNA using inhouse real-time PCR. Results HSV shedding was mainly subclinical (90%; 57/63 shedding days in the placebo arm). The most frequent shedding site was the external skin, but HSV DNA was detected from all three sites on 42% (27/63) of shedding days. In HIV-negative women, HSV DNA was detected on 3% (9/275) of days in the acyclovir versus 11% (33/309) in the placebo arm, while in HIV-positive women, detection was on 14% (23/160) versus 19% (30/155) of days, respectively. Conclusions HSV shedding was common, varying greatly by individual. Shedding rates were similar to studies in African and non-African settings. Among HIV-negative women, shedding rates were lower in the acyclovir arm; however, acyclovir did not substantially impact on HSV shedding in HIV-positive women. PMID:21653932

Spiral structure of M51: Streaming motions across the spiral arms

NASA Technical Reports Server (NTRS)

Tilanus, R. P. J.; Allen, R. J.

1990-01-01

The atomic hydrogen (HI) and the H alpha emission line in the grand-design spiral galaxy M51 have been observed with the Westerbork Synthesis Radio Telescope and the Taurus Fabry-Perot imaging spectrometer, respectively. Across the inner spiral arms significant tangential and radial velocity gradients are detected in the H alpha emission after subtraction of the axi-symmetric component of the velocity field. The shift is positive on the inside and negative on the outside of the northern arm. Across the southern arm this situation is reversed. The direction of the shifts is such that the material is moving inward and faster compared to circular rotation in both arms, consistent with the velocity perturbations predicted by spiral density wave models for gas downstream of a spiral shock. The observed shifts amount to 20 to 30 km (s-1), corresponding to streaming motions of 60 to 90 km (s-1) in the plane of the disk (inclination angle 20 degrees). Comparable velocity gradients have also been observed by Vogel et al. in the CO emission from the inner northern arm of M51. The streaming motions in M51 are about 2 to 3 times as large as the ones found in HI by Rots in M81, and successfully modelled by Visser with a self-consistent density wave model. Researchers have not been able to detect conclusively streaming motions in the HI emission from the arms, perhaps due to the relatively poor angular resolution (approx. 15 seconds) of the HI observations.

[The sanitary protection of Armed Forces employed abroad].

PubMed

Pasini, W

2006-01-01

After recalling the numerous peace expeditions of the Italian Armed Forces in foreign countries, the author underlines the several health risk factors that such missions imply. The assessment of the biological risk should be based on the knowledge of the local sanitary situation and on the analysis of the operative characteristics of the mission: prevention is based on vaccinations (with plans based on the operative tasks and destinations) and on antimalaric chemoprophylaxis, carried out following WHO indications. In conclusion, the current organization of military field hospitals is briefly described.

Plastid and mitochondrion genomic sequences from Arctic Chlorella sp. ArM0029B

PubMed Central

2014-01-01

Background Chorella is the representative taxon of Chlorellales in Trebouxiophyceae, and its chloroplast (cp) genomic information has been thought to depend only on studies concerning Chlorella vulgaris and GenBank information of C. variablis. Mitochondrial (mt) genomic information regarding Chlorella is currently unavailable. To elucidate the evolution of organelle genomes and genetic information of Chlorella, we have sequenced and characterized the cp and mt genomes of Arctic Chlorella sp. ArM0029B. Results The 119,989-bp cp genome lacking inverted repeats and 65,049-bp mt genome were sequenced. The ArM0029B cp genome contains 114 conserved genes, including 32 tRNA genes, 3 rRNA genes, and 79 genes encoding proteins. Chlorella cp genomes are highly rearranged except for a Chlorella-specific six-gene cluster, and the ArM0029B plastid resembles that of Chlorella variabilis except for a 15-kb gene cluster inversion. In the mt genome, 62 conserved genes, including 27 tRNA genes, 3 rRNA genes, and 32 genes encoding proteins were determined. The mt genome of ArM0029B is similar to that of the non-photosynthetic species Prototheca and Heicosporidium. The ArM0029B mt genome contains a group I intron, with an ORF containing two LAGLIDADG motifs, in cox1. The intronic ORF is shared by C. vulgaris and Prototheca. The phylogeny of the plastid genome reveals that ArM0029B showed a close relationship of Chlorella to Parachlorella and Oocystis within Chlorellales. The distribution of the cox1 intron at 721 support membership in the order Chlorellales. Mitochondrial phylogenomic analyses, however, indicated that ArM0029B shows a greater affinity to MX-AZ01 and Coccomyxa than to the Helicosporidium-Prototheca clade, although the detailed phylogenetic relationships among the three taxa remain to be resolved. Conclusions The plastid genome of ArM0029B is similar to that of C. variabilis. The mt sequence of ArM0029B is the first genome to be reported for Chlorella. Chloroplast genome phylogeny supports monophyly of the seven investigated members of Chlorellales. The presence of the cox1 intron at 721 in all four investigated Chlorellales taxa indicates that the cox1 intron had been introduced in early Chorellales as a cis-splice form and that the cis-splicing intron was inherited to recent Chlorellales and was recently trans-spliced in Helicosporidium. PMID:24735464

Randomized Phase 2 Trial of S1 and Oxaliplatin-Based Chemoradiotherapy With or Without Induction Chemotherapy for Esophageal Cancer

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

Yoon, Dok Hyun; Jang, Geundoo; Department of Internal Medicine, Hallym Medical Center, Hallym University College of Medicine, Seoul

2015-03-01

Purpose: To assess, in a randomized, phase 2 trial, the efficacy and safety of chemoradiotherapy with or without induction chemotherapy (ICT) of S1 and oxaliplatin for esophageal cancer. Patients and Methods: Patients with stage II, III, or IVA esophageal cancer were randomly allocated to either 2 cycles of ICT (oxaliplatin 130 mg/m{sup 2} on day 1 and S1 at 40 mg/m{sup 2} twice daily on days 1-14, every 3 weeks) followed by concurrent chemoradiotherapy (CCRT) (46 Gy, 2 Gy/d with oxaliplatin 130 mg/m{sup 2} on days 1 and 21 and S1 30 mg/m{sup 2} twice daily, 5 days per week during radiation therapy) and esophagectomy (arm A), ormore » the same CCRT followed by esophagectomy without ICT (arm B). The primary endpoint was the pathologic complete response (pCR) rate. Results: A total of 97 patients were randomized (arm A/B, 47/50), 70 of whom underwent esophagectomy (arm A/B, 34/36). The intention-to-treat pCR rate was 23.4% (95% confidence interval [CI] 11.2-35.6%) in arm A and 38% (95% CI 24.5% to 51.5%) in arm B. With a median follow-up duration of 30.3 months, the 2-year progression-free survival rate was 58.4% in arm A and 58.6% in arm B, whereas the 2-year overall survival rate was 60.7% and 63.7%, respectively. Grade 3 or 4 thrombocytopenia during CCRT was more common in arm A than in arm B (35.4% vs 4.1%). The relative dose intensity of S1 (89.5% ± 20.6% vs 98.3% ± 5.2%, P=.005) and oxaliplatin (91.4% ± 16.8% vs 99.0% ± 4.2%, P=.007) during CCRT was lower in arm A compared with arm B. Three patients in arm A, compared with none in arm B, died within 90 days after surgery. Conclusions: Combination chemotherapy of S1 and oxaliplatin is an effective chemoradiotherapy regimen to treat esophageal cancer. However, we failed to show that the addition of ICT to the regimen can improve the pCR rate.« less

Safety and Survival With GVAX Pancreas Prime and Listeria Monocytogenes–Expressing Mesothelin (CRS-207) Boost Vaccines for Metastatic Pancreatic Cancer

PubMed Central

Le, Dung T.; Wang-Gillam, Andrea; Picozzi, Vincent; Greten, Tim F.; Crocenzi, Todd; Springett, Gregory; Morse, Michael; Zeh, Herbert; Cohen, Deirdre; Fine, Robert L.; Onners, Beth; Uram, Jennifer N.; Laheru, Daniel A.; Lutz, Eric R.; Solt, Sara; Murphy, Aimee Luck; Skoble, Justin; Lemmens, Ed; Grous, John; Dubensky, Thomas; Brockstedt, Dirk G.; Jaffee, Elizabeth M.

2015-01-01

Purpose GVAX pancreas, granulocyte-macrophage colony-stimulating factor–secreting allogeneic pancreatic tumor cells, induces T-cell immunity to cancer antigens, including mesothelin. GVAX is administered with low-dose cyclophosphamide (Cy) to inhibit regulatory T cells. CRS-207, live-attenuated Listeria monocytogenes–expressing mesothelin, induces innate and adaptive immunity. On the basis of preclinical synergy, we tested prime/boost vaccination with GVAX and CRS-207 in pancreatic adenocarcinoma. Patients and Methods Previously treated patients with metastatic pancreatic adenocarcinoma were randomly assigned at a ratio of 2:1 to two doses of Cy/GVAX followed by four doses of CRS-207 (arm A) or six doses of Cy/GVAX (arm B) every 3 weeks. Stable patients were offered additional courses. The primary end point was overall survival (OS) between arms. Secondary end points were safety and clinical response. Results A total of 90 patients were treated (arm A, n = 61; arm B, n = 29); 97% had received prior chemotherapy; 51% had received ≥ two regimens for metastatic disease. Mean number of doses (± standard deviation) administered in arms A and B were 5.5 ± 4.5 and 3.7 ± 2.2, respectively. The most frequent grade 3 to 4 related toxicities were transient fevers, lymphopenia, elevated liver enzymes, and fatigue. OS was 6.1 months in arm A versus 3.9 months in arm B (hazard ratio [HR], 0.59; P = .02). In a prespecified per-protocol analysis of patients who received at least three doses (two doses of Cy/GVAX plus one of CRS-207 or three of Cy/GVAX), OS was 9.7 versus 4.6 months (arm A v B; HR, 0.53; P = .02). Enhanced mesothelin-specific CD8 T-cell responses were associated with longer OS, regardless of treatment arm. Conclusion Heterologous prime/boost with Cy/GVAX and CRS-207 extended survival for patients with pancreatic cancer, with minimal toxicity. PMID:25584002

Indoor Residual Spraying in Combination with Insecticide-Treated Nets Compared to Insecticide-Treated Nets Alone for Protection against Malaria: A Cluster Randomised Trial in Tanzania

PubMed Central

West, Philippa A.; Protopopoff, Natacha; Wright, Alexandra; Kivaju, Zuhura; Tigererwa, Robinson; Mosha, Franklin W.; Kisinza, William; Rowland, Mark; Kleinschmidt, Immo

2014-01-01

Background Insecticide-treated nets (ITNs) and indoor residual spraying (IRS) of houses provide effective malaria transmission control. There is conflicting evidence about whether it is more beneficial to provide both interventions in combination. A cluster randomised controlled trial was conducted to investigate whether the combination provides added protection compared to ITNs alone. Methods and Findings In northwest Tanzania, 50 clusters (village areas) were randomly allocated to ITNs only or ITNs and IRS. Dwellings in the ITN+IRS arm were sprayed with two rounds of bendiocarb in 2012. Plasmodium falciparum prevalence rate (PfPR) in children 0.5–14 y old (primary outcome) and anaemia in children <5 y old (secondary outcome) were compared between study arms using three cross-sectional household surveys in 2012. Entomological inoculation rate (secondary outcome) was compared between study arms. IRS coverage was approximately 90%. ITN use ranged from 36% to 50%. In intention-to-treat analysis, mean PfPR was 13% in the ITN+IRS arm and 26% in the ITN only arm, odds ratio = 0.43 (95% CI 0.19–0.97, n = 13,146). The strongest effect was observed in the peak transmission season, 6 mo after the first IRS. Subgroup analysis showed that ITN users were additionally protected if their houses were sprayed. Mean monthly entomological inoculation rate was non-significantly lower in the ITN+IRS arm than in the ITN only arm, rate ratio = 0.17 (95% CI 0.03–1.08). Conclusions This is the first randomised trial to our knowledge that reports significant added protection from combining IRS and ITNs compared to ITNs alone. The effect is likely to be attributable to IRS providing added protection to ITN users as well as compensating for inadequate ITN use. Policy makers should consider deploying IRS in combination with ITNs to control transmission if local ITN strategies on their own are insufficiently effective. Given the uncertain generalisability of these findings, it would be prudent for malaria control programmes to evaluate the cost-effectiveness of deploying the combination. Trial registration www.ClinicalTrials.gov NCT01697852 Please see later in the article for the Editors' Summary PMID:24736370

DIABEO App Software and Telemedicine Versus Usual Follow-Up in the Treatment of Diabetic Patients: Protocol for the TELESAGE Randomized Controlled Trial

PubMed Central

Chaillous, Lucy; Franc, Sylvia; Benhamou, Pierre-Yves; Schaepelynck, Pauline; Hanaire, Hélène; Catargi, Bogdan; Farret, Anne; Fontaine, Pierre; Guerci, Bruno; Reznik, Yves; Penfornis, Alfred; Borot, Sophie; Serusclat, Pierre; Kherbachi, Yacine; D'Orsay, Geneviève; Detournay, Bruno; Simon, Pierre; Charpentier, Guillaume

2018-01-01

Background Self-management of diabetes minimizes the risk of macrovascular and microvascular complications, but understanding and/or adherence to self-management recommendations is often suboptimal. DIABEO is a smartphone app (downloaded via the internet) used to calculate bolus insulin doses. A previous study (TELEDIAB 1) showed that the use of DIABEO was associated with a significant improvement in glycemic control in patients with poorly controlled type 1 diabetes mellitus, particularly when combined with teleconsultations with physicians. Objective Here, we present the protocol for a new study (Suivi A Grande Echelle d’une cohorte de diabétiques de type 1 et de type 2 sous schéma insulinique basal bolus par la TELEmédecine; abbreviated TELESAGE), conducted in a larger population of diabetic patients with poorly controlled basal-bolus insulin levels. Methods TELESAGE is a multicenter, double-randomized, open-label, three parallel–arms study, conducted in approximately 100 centers in France. The study will compare a control group (arm 1: usual follow-up) with two DIABEO telemedicine systems: (1) physician-assisted telemedicine (arm 2), and (2) nurse-assisted telemonitoring and teleconsultations by a diabetologist’s task delegation (arm 3). Initial randomization will allocate the study arms in 12 French regions. A second randomization will assign patients in the groups allocated to each studied region. The primary objective of TELESAGE will be to investigate the effect of the DIABEO telemedicine system versus usual follow-up, with respect to improvements in the glycated hemoglobin levels of approximately 696 diabetic patients with poorly controlled basal-bolus insulin levels. Results The TELESAGE study is sponsored by Sanofi (Gentilly, France). A primary completion date is expected in June 2018, and publication of results is expected within 6 months of work completion. Conclusions The TELESAGE study is expected to confirm the previous results of the TELEDIAB 1 study using a larger sample of diabetic patients. It is also expected to evaluate a nurse-assisted telemonitoring system. We will assess the potential of the DIABEO telemedicine service in terms of its utility and explore whether it can become an integral part of diabetes care for patients. Trial Registration ClinicalTrials.gov NCT02287532; https://clinicaltrials.gov/ct2/show/NCT02287532 (Archived by WebCite at http://www.webcitation.org/6ykajhJKd) PMID:29674306

Patterns of Cortical Synchronization in Isolated Dystonia Compared With Parkinson Disease

PubMed Central

Miocinovic, Svjetlana; de Hemptinne, Coralie; Qasim, Salman; Ostrem, Jill L.; Starr, Philip A.

2016-01-01

IMPORTANCE Isolated dystonia and Parkinson disease (PD) are disorders of the basal gangliothalamocortical network. They have largely distinct clinical profiles, but both disorders respond to deep brain stimulation (DBS) in the same subcortical targets using similar stimulation paradigms, suggesting pathophysiologic overlap. We hypothesized that, similar to PD, isolated dystonia is associated with elevated cortical neuronal synchronization. OBJECTIVE To investigate the electrophysiologic characteristics of the sensorimotor cortex arm-related area using a temporary subdural electrode strip in patients with isolated dystonia and PD undergoing DBS implantation in the awake state. DESIGN, SETTING, AND PARTICIPANTS An observational study recruited patients scheduled for DBS at the University of California, San Francisco and the San Francisco Veterans Affairs Medical Center. Data were collected from May 1, 2008, through April 1, 2015. Findings are reported for 22 patients with isolated cervical or segmental dystonia (8 with [DYST-ARM] and 14 without [DYST] arm symptoms] and 14 patients with akinetic rigid PD. Data were analyzed from November 1, 2014, through May 1, 2015. MAIN OUTCOMES AND MEASURES Cortical local field potentials, power spectral density, and phase-amplitude coupling (PAC). RESULTS Among our 3 groups that together included 36 patients, cortical PAC was present in primary motor and premotor arm-related areas for all groups, but the DYST group was less likely to exhibit increased PAC (P = .008). Similar to what has been shown for patients with PD, subthalamic DBS reversibly decreased PAC in a subset of patients with dystonia who were studied before and during intraoperative test stimulation (n = 4). At rest, broadband gamma (50–200 Hz) power in the primary motor cortex was greater in the DYST-ARM and PD groups compared with the DYST group, whereas alpha (8–13 Hz) and beta (13–30 Hz) power was comparable in all 3 groups. During movement, the DYST-ARM group had impaired beta and low gamma desynchronization in the primary motor cortex. CONCLUSIONS AND RELEVANCE Isolated dystonia and PD have physiologic overlap with respect to high levels of motor cortex synchronization and reduction of cortical synchronization by subthalamic DBS, providing an explanation for their similar therapeutic response to basal ganglia stimulation. PMID:26409266

Randomized, Multicenter Trial on the Effect of Radiation Therapy on Plantar Fasciitis (Painful Heel Spur) Comparing a Standard Dose With a Very Low Dose: Mature Results After 12 Months' Follow-Up

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

Niewald, Marcus, E-mail: marcus.niewald@uks.eu; Seegenschmiedt, M. Heinrich; Micke, Oliver

2012-11-15

Purpose: To conduct a randomized trial of radiation therapy for painful heel spur, comparing a standard dose with a very low dose. Methods and Materials: Sixty-six patients were randomized to receive radiation therapy either with a total dose of 6.0 Gy applied in 6 fractions of 1.0 Gy twice weekly (standard dose) or with a total dose of 0.6 Gy applied in 6 fractions of 0.1 Gy twice weekly (low dose). In all patients lateral opposing 4- to 6-MV photon beams were used. The results were measured using a visual analogue scale, the Calcaneodynia score, and the SF12 health survey.more » The fundamental phase of the study ended after 3 months, and the follow-up was continued up to 1 year. Patients with insufficient pain relief after 3 months were offered reirradiation with the standard dosage at any time afterward. Results: Of 66 patients, 4 were excluded because of withdrawal of consent or screening failures. After 3 months the results in the standard arm were highly significantly superior compared with those in the low-dose arm (visual analogue scale, P=.001; Calcaneodynia score, P=.027; SF12, P=.045). The accrual of patients was stopped at this point. Further evaluation after 12 months' follow-up showed the following results: (1) highly significant fewer patients were reirradiated in the standard arm compared with the low-dose arm (P<.001); (2) the results of patients in the low-dose arm who were reirradiated were identical to those in the standard arm not reirradiated (reirradiation as a salvage therapy if the lower dose was ineffective); (3) patients experiencing a favorable result after 3 months showed this even after 12 months, and some results even improved further between 3 and 12 months. Conclusions: This study confirms the superior analgesic effect of radiation therapy with 6-Gy doses on painful heel spur even for a longer time period of at least 1 year.« less

Mitochondrial DNA haplogroups confer differences in risk for age-related macular degeneration: a case control study

PubMed Central

2013-01-01

Background Age-related macular degeneration (AMD) is the leading cause of vision loss in elderly, Caucasian populations. There is strong evidence that mitochondrial dysfunction and oxidative stress play a role in the cell death found in AMD retinas. The purpose of this study was to examine the association of the Caucasian mitochondrial JTU haplogroup cluster with AMD. We also assessed for gender bias and additive risk with known high risk nuclear gene SNPs, ARMS2/LOC387715 (G > T; Ala69Ser, rs10490924) and CFH (T > C; Try402His, rs1061170). Methods Total DNA was isolated from 162 AMD subjects and 164 age-matched control subjects located in Los Angeles, California, USA. Polymerase chain reaction (PCR) and restriction enzyme digestion were used to identify the J, U, T, and H mitochondrial haplogroups and the ARMS2-rs10490924 and CFH-rs1061170 SNPs. PCR amplified products were sequenced to verify the nucleotide substitutions for the haplogroups and ARMS2 gene. Results The JTU haplogroup cluster occurred in 34% (55/162) of AMD subjects versus 15% (24/164) of normal (OR = 2.99; p = 0.0001). This association was slightly greater in males (OR = 3.98, p = 0.005) than the female population (OR = 3.02, p = 0.001). Assuming a dominant effect, the risk alleles for the ARMS2 (rs10490924; p = 0.00001) and CFH (rs1061170; p = 0.027) SNPs were significantly associated with total AMD populations. We found there was no additive risk for the ARMS2 (rs10490924) or CFH (rs1061170) SNPs on the JTU haplogroup background. Conclusions There is a strong association of the JTU haplogroup cluster with AMD. In our Southern California population, the ARMS2 (rs10490924) and CFH (rs1061170) genes were significantly but independently associated with AMD. SNPs defining the JTU mitochondrial haplogroup cluster may change the retinal bioenergetics and play a significant role in the pathogenesis of AMD. PMID:23302509

Multicentric GISCoR Study "intensive clinical follow-up versus surgical radicalization after complete endoscopic polypectomy of a malignant adenoma" (SEC-GISCoR).

PubMed

Andreoni, Bruno; Camellini, Lorenzo; Sonzogni, Angelica; Crosta, Cristiano; Pirola, Maria Elena; Corbellini, Carlo

2011-09-01

Colorectal cancer screening programs result in an early diagnosis of the disease. In 2007, 250 malignant polyps were identified in Lombardy, out of 1,329 screen-detected colorectal carcinomas. The Italian Group for Colorectal Cancer (GISCoR) promoted the multicentric study "Endoscopic Follow-up versus Surgical Radicalization of Malignant Polyps after Complete Endoscopic Polypectomy" (SEC-GISCoR). The protocol was a multicentric, prospective, observational, non-randomized study. It included patients diagnosed a colorectal malignant adenoma, after complete endoscopic removal. From November 2005 to September 2009, three participating centers enrolled 120 patients with malignant polyps after "complete" endoscopic polypectomy; malignant polyps were classified as "low risk" or "high risk". The study had two arms: "Intensive follow-up" (42 patients: 32 with low-risk and 10 with high-risk polyps) and "Surgical radicalization" (78 patients: 5 with low-risk and 73 with high-risk polyps). Data were collected using an online CRF. Overall, 37/120 polyps (30.8%) were low risk and 83/120 (69.2%) were high risk. 42 out of 120 patients (35%) were enrolled in the "clinical follow-up" arm, while 78/120 (65%) entered the surgery arm. In 15 cases, patients were not enrolled in the correct arm, according to the criteria agreed upon before starting the study. There still is a high incidence (11.5%) of pathological mismatches. No clinical event was reported in 2.9 years of follow-up. In conclusion, some differences emerged in the management of patients with malignant polyps among participating centers (p < 0.001), mismatches can be explained by high surgical risk or patient's choice. Only in 5 cases (4.2%), did data analysis not allow to exactly determine the reason for a choice different from protocol criteria. The availability of new risk factors and the evidence of pathological mismatches confirmed the need for future studies on this issue.

Polymorphisms in ARMS2/HTRA1 and Complement Genes and Age-Related Macular Degeneration in India: Findings from the INDEYE Study

PubMed Central

Sundaresan, Periasamy; Vashist, Praveen; Ravindran, Ravilla D.; Shanker, Ashwini; Nitsch, Dorothea; Nonyane, Bareng A. S.; Smeeth, Liam; Chakravarthy, Usha; Fletcher, Astrid E.

2012-01-01

Purpose. Association between genetic variants in complement factor H (CFH), factor B (CFB), component 2 (C2), and in the ARMS2/HTRA1 region with age-related macular degeneration (AMD) comes mainly from studies of European ancestry and case-control studies of late-stage disease. We investigated associations of both early and late AMD with these variants in a population-based study of people aged 60 years and older in India. Methods. Fundus images were graded using the Wisconsin Age-Related Maculopathy Grading System and participants assigned to one of four mutually exclusive stages based on the worse affected eye (0 = no AMD, 1–3 = early AMD, 4 = late AMD). Multinomial logistic regression was used to derive risk ratios (RR) accounting for sampling method and adjusting for age, sex, and study center. Results. Of 3569 participants, 53.2% had no signs of AMD, 45.6% had features of early AMD, and 1.2% had late AMD. CFH (rs1061170), C2 (rs547154), or CFB (rs438999) was not associated with early or late AMD. In the ARMS2 locus, rs10490924 was associated with both early (adjusted RR 1.22, 95% confidence interval [CI]: 1.13–1.33, P < 0.0001) and late AMD (adjusted RR 1.81, 95% CI: 1.15–2.86; P = 0.01); rs2672598 was associated only with early AMD (adjusted RR 1.12, 95% CI: 1.02–1.23; P = 0.02); rs10490923 was not associated with early or late AMD. Conclusions. Two variants in ARMS2/HTRA1 were associated with increased risk of early AMD, and for one of these, the increased risk was also evident for late AMD. The study provides new insights into the role of these variants in early stages of AMD in India. PMID:23060141

The role of the Data and Safety Monitoring Board in a clinical trial: The CRISIS Study

PubMed Central

Holubkov, Richard; Casper, T. Charles; Dean, J. Michael; Anand, K. J. S.; Zimmerman, Jerry; Meert, Kathleen L.; Newth, Christopher J. L.; Berger, John; Harrison, Rick; Willson, Douglas F.; Nicholson, Carol

2012-01-01

Objective Randomized clinical trials are commonly overseen by a data and safety monitoring board (DSMB) comprised of experts in medicine, ethics, and biostatistics. DSMB responsibilities include protocol approval, interim review of study enrollment, protocol compliance, safety, and efficacy data. DSMB decisions can affect study design and conduct, as well as reported findings. Researchers must incorporate DSMB oversight into the design, monitoring, and reporting of randomized trials. Design Case study, narrative review. Methods The DSMB’s role during the comparative pediatric Critical Illness Stress-Induced Immune Suppression (CRISIS) Prevention Trial is described. Findings The NIH-appointed CRISIS DSMB was charged with monitoring sample size adequacy and feasibility, safety with respect to adverse events and 28-day mortality, and efficacy with respect to the primary nosocomial infection/sepsis outcome. The Federal Drug Administration also requested DSMB interim review before opening CRISIS to children below one year of age. The first interim analysis found higher 28-day mortality in one treatment arm. The DSMB maintained trial closure to younger children, and requested a second interim data review six months later. At this second meeting, mortality was no longer of concern, while a weak efficacy trend of lower infection/sepsis rates in one study arm emerged. As over 40% of total patients had been enrolled, the DSMB elected to examine conditional power, and unmask treatment arm identities. Upon finding somewhat greater efficacy in the placebo arm, the DSMB recommended stopping CRISIS due to futility. Conclusions The design and operating procedures of a multicenter randomized trial must consider a pivotal DSMB role. Maximum study design flexibility must be allowed, and investigators must be prepared for protocol modifications due to interim findings. The DSMB must have sufficient clinical and statistical expertise to assess potential importance of interim treatment differences in the setting of multiple looks at accumulating data with numerous outcomes and subgroups. PMID:23392377

Vampire squid: detritivores in the oxygen minimum zone

PubMed Central

Hoving, Hendrik J. T.; Robison, Bruce H.

2012-01-01

Vampire squid (Vampyroteuthis infernalis) are considered phylogenetic relics with cephalopod features of both octopods and squids. They lack feeding tentacles, but in addition to their eight arms, they have two retractile filaments, the exact functions of which have puzzled scientists for years. We present the results of investigations on the feeding ecology and behaviour of Vampyroteuthis, which include extensive in situ, deep-sea video recordings from MBARI's remotely operated vehicles (ROVs), laboratory feeding experiments, diet studies and morphological examinations of the retractile filaments, the arm suckers and cirri. Vampire squid were found to feed on detrital matter of various sizes, from small particles to larger marine aggregates. Ingested items included the remains of gelatinous zooplankton, discarded larvacean houses, crustacean remains, diatoms and faecal pellets. Both ROV observations and laboratory experiments led to the conclusion that vampire squid use their retractile filaments for the capture of food, supporting the hypothesis that the filaments are homologous to cephalopod arms. Vampyroteuthis' feeding behaviour is unlike any other cephalopod, and reveals a unique adaptation that allows these animals to spend most of their life at depths where oxygen concentrations are very low, but where predators are few and typical cephalopod food is scarce. PMID:23015627

Vampire squid: detritivores in the oxygen minimum zone.

PubMed

Hoving, Hendrik J T; Robison, Bruce H

2012-11-22

Vampire squid (Vampyroteuthis infernalis) are considered phylogenetic relics with cephalopod features of both octopods and squids. They lack feeding tentacles, but in addition to their eight arms, they have two retractile filaments, the exact functions of which have puzzled scientists for years. We present the results of investigations on the feeding ecology and behaviour of Vampyroteuthis, which include extensive in situ, deep-sea video recordings from MBARI's remotely operated vehicles (ROVs), laboratory feeding experiments, diet studies and morphological examinations of the retractile filaments, the arm suckers and cirri. Vampire squid were found to feed on detrital matter of various sizes, from small particles to larger marine aggregates. Ingested items included the remains of gelatinous zooplankton, discarded larvacean houses, crustacean remains, diatoms and faecal pellets. Both ROV observations and laboratory experiments led to the conclusion that vampire squid use their retractile filaments for the capture of food, supporting the hypothesis that the filaments are homologous to cephalopod arms. Vampyroteuthis' feeding behaviour is unlike any other cephalopod, and reveals a unique adaptation that allows these animals to spend most of their life at depths where oxygen concentrations are very low, but where predators are few and typical cephalopod food is scarce.

The Effects of Inflammatory Tooth Pain on Anxiety in Adult Male Rats

PubMed Central

Raoof, Maryam; Ebrahimnejad, Hamed; Abbasnejad, Mehdi; Amirkhosravi, Ladan; Raoof, Ramin; Esmaeili Mahani, Saeed; Ramazani, Mohsen; Shokouhinejad, Noushin; Khoshkhounejad, Mehrfam

2016-01-01

Introduction: This study aimed to examine the effects of induced inflammatory tooth pain on anxiety level in adult male rats. Methods: The mandibular incisors of 56 adult male rats were cut off and prefabricated crowns were fixed on the teeth. Formalin and capsaicin were injected intradentally to induce inflammatory tooth pain. Diazepam treated group received diazepam 30 minutes before intradental injection. The anxiety-related behavior was evaluated with elevated plus maze test. Results: Intradental application of chemical noxious stimuli, capsaicin and formalin, significantly affected nociceptive behaviors (P<0.001). Capsaicin (P<0.001) and formalin (P<0.01) significantly increased the anxiety levels in rats by decrease in the duration of time spent in open arm and increase in the duration of time spent in closed arm. Rats that received capsaicin made fewer open arm entries compared to the control animals (P<0.05). Capsaicin (P<0.001) and formalin (P<0.01) treated rats showed more stretch attend postures compared to the control and sham operated animals. In diazepampretreated rats, capsaicin induced algesic effect was prevented (P<0.001). Conclusion: Inflammatory pulpal pain has anxiogenic effect on rats, whereas diazepam premedication showed both anxiolytic and pain reducing effects. PMID:27563419

The value of INnovative ICT guided disease management combined with Telemonitoring in OUtpatient clinics for Chronic Heart failure patients. Design and methodology of the IN TOUCH study: a multicenter randomised trial

PubMed Central

2011-01-01

Background Although the value of telemonitoring in heart failure patients is increasingly studied, little is known about the value of the separate components of telehealth: ICT guided disease management and telemonitoring. The aim of this study is to investigate the value of telemonitoring added to ICT guided disease management (DM) on the quality and efficiency of care in patients with chronic heart failure (CHF) after a hospitalisation. Methods/Design The study is divided in two arms; a control arm (DM) and an intervention arm (DM+TM) in 10 hospitals in the Netherlands. In total 220 patients will be included after worsening of CHF (DM: N = 90, DM+TM: N = 130). Total follow-up will be 9 months. Data will be collected at inclusion and then after 2 weeks, 4.5 and 9 months. The primary endpoint of this study is a composite score of: 1: death from any cause during the follow-up of the study, 2: first readmission for HF and 3: change in quality of life compared to baseline, assessed by the Minnesota Living with Heart failure Questionnaire. The study has started in December 2009 and results are expected in 2012. Conclusions The IN TOUCH study is the first to investigate the effect of telemonitoring on top of ICT guided DM on the quality and efficiency of care in patients with worsening HF and will use a composite score as its primary endpoint. Trial registration Netherlands Trial Register (NTR): NTR1898 PMID:21752280

SU-E-T-598: The Effects of Arm Speed for Quality Assurance and Commissioning Measurements in Rectangular and Cylindrical Scanners

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

Bakhtiari, M; Schmitt, J

2014-06-01

Purpose: Cylindrical and rectangular scanning water tanks are examined with different scanning speeds to investigate the TG-106 criteria and the errors induced in the measurements. Methods: Beam profiles were measured in a depth of R50 for a low-energy electron beam (6 MeV) using rectangular and cylindrical tanks. The speeds of the measurements (arm movement) were varied in different profile measurements. Each profile was measured with a certain speed to obtain the average and standard deviation as a parameter for investigating the reproducibility and errors. Results: At arm speeds of ∼0.8 mm/s the errors were as large as 2% and 1%more » with rectangular and cylindrical tanks, respectively. The errors for electron beams and for photon beams in other depths were within the TG-106 criteria of 1% for both tank shapes. Conclusion: The measurements of low-energy electron beams in a depth of R50, as an extreme case scenario, are sensitive to the speed of the measurement arms for both rectangular and cylindrical tanks. The measurements in other depths, for electron beams and photon beams, with arm speeds of less than 1 cm/s are within the TG-106 criteria. An arm speed of 5 mm/s appeared to be optimal for fast and accurate measurements for both cylindrical and rectangular tanks.« less

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

Zhang, P; Kuo, L; Yorke, E

Purpose: To develop a biological modeling strategy which incorporates the response observed on the mid-treatment PET/CT into a dose escalation design for adaptive radiotherapy of non-small-cell lung cancer. Method: FDG-PET/CT was acquired midway through standard fractionated treatment and registered to pre-treatment planning PET/CT to evaluate radiation response of lung cancer. Each mid-treatment PET voxel was assigned the median SUV inside a concentric 1cm-diameter sphere to account for registration and imaging uncertainties. For each voxel, the planned radiation dose, pre- and mid-treatment SUVs were used to parameterize the linear-quadratic model, which was then utilized to predict the SUV distribution after themore » full prescribed dose. Voxels with predicted post-treatment SUV≥2 were identified as the resistant target (response arm). An adaptive simultaneous integrated boost was designed to escalate dose to the resistant target as high as possible, while keeping prescription dose to the original target and lung toxicity intact. In contrast, an adaptive target volume was delineated based only on the intensity of mid-treatment PET/CT (intensity arm), and a similar adaptive boost plan was optimized. The dose escalation capability of the two approaches was compared. Result: Images of three patients were used in this planning study. For one patient, SUV prediction indicated complete response and no necessary dose escalation. For the other two, resistant targets defined in the response arm were multifocal, and on average accounted for 25% of the pre-treatment target, compared to 67% in the intensity arm. The smaller response arm targets led to a 6Gy higher mean target dose in the adaptive escalation design. Conclusion: This pilot study suggests that adaptive dose escalation to a biologically resistant target predicted from a pre- and mid-treatment PET/CT may be more effective than escalation based on the mid-treatment PET/CT alone. More plans and ultimately clinical protocols are needed to validate this approach. MSKCC has a research agreement with Varian Medical System.« less

Energy Expenditure Evaluation in Humans and Non-Human Primates by SenseWear Armband. Validation of Energy Expenditure Evaluation by SenseWear Armband by Direct Comparison with Indirect Calorimetry

PubMed Central

Casiraghi, Francesca; Chavez, Alberto O.; Davalli, Alberto M.; Naegelin, Terry; Comuzzie, Anthony G.; Frost, Patricia; Musi, Nicolas; Folli, Franco

2013-01-01

Introduction The purpose of this study was to compare and validate the use of SenseWear Armband (SWA) placed on the arm (SWA ARM) and on the back (SWA BACK) in healthy humans during resting and a cycle-ergometer exercise and to evaluate the SWA to estimate Resting Energy Expenditure (REE) and Total Energy Expenditure (TEE) in healthy baboons. Methods We studied 26 (15F/11M) human subjects wearing SWA in two different anatomical sites (arm and back) during resting and a cycle-ergometer test and directly compared these results with indirect calorimetry evaluation (IC), performed at the same time. We then inserted the SWA in a metabolic jacket for baboons and evaluated the TEE and REE in free living condition for 6 days in 21 (8F/13M) non-human primates. Results In humans we found a good correlation between SWA place on the ARM and on the BACK with IC during the resting experiment (1.1±0.3 SWAs, 1±0.2 IC kcal/min) and a slight underestimation in the SWAs data compared with IC during the cycle-ergometer exercise (5±1.9 SWA ARM, 4.5±1.5 SWA BACK and 5.4±2.1 IC kcal/min). In the non-human primate (baboons) experiment SWA estimated a TEE of 0.54±0.009 kcal/min during free living and a REE of 0.82±0.06 kcal/min. Conclusion SWA, an extremely simple and inexpensive apparatus, provides quite accurate measurements of energy expenditure in humans and in baboons. Energy expenditure data obtained with SWA are highly correlated with the data obtained with “gold standard”, IC, in humans. PMID:24069218

Effects of Source- versus Household Contamination of Tubewell Water on Child Diarrhea in Rural Bangladesh: A Randomized Controlled Trial

PubMed Central

Unicomb, Leanne; Arnold, Benjamin F.; Colford Jr., John M.; Luby, Stephen P.

2015-01-01

Background Shallow tubewells are the primary drinking water source for most rural Bangladeshis. Fecal contamination has been detected in tubewells, at low concentrations at the source and at higher levels at the point of use. We conducted a randomized controlled trial to assess whether improving the microbiological quality of tubewell drinking water by household water treatment and safe storage would reduce diarrhea in children <2 years in rural Bangladesh. Methods We randomly assigned 1800 households with a child aged 6-18 months (index child) into one of three arms: chlorine plus safe storage, safe storage and control. We followed households with monthly visits for one year to promote the interventions, track their uptake, test participants’ source and stored water for fecal contamination, and record caregiver-reported child diarrhea prevalence (primary outcome). To assess reporting bias, we also collected data on health outcomes that are not expected to be impacted by our interventions. Findings Both interventions had high uptake. Safe storage, alone or combined with chlorination, reduced heavy contamination of stored water. Compared to controls, diarrhea in index children was reduced by 36% in the chlorine plus safe storage arm (prevalence ratio, PR = 0.64, 0.55-0.73) and 31% in the safe storage arm (PR = 0.69, 0.60-0.80), with no difference between the two intervention arms. One limitation of the study was the non-blinded design with self-reported outcomes. However, the prevalence of health outcomes not expected to be impacted by water interventions did not differ between study arms, suggesting minimal reporting bias. Conclusions Safe storage significantly improved drinking water quality at the point of use and reduced child diarrhea in rural Bangladesh. There was no added benefit from combining safe storage with chlorination. Efforts should be undertaken to implement and evaluate long-term efforts for safe water storage in Bangladesh. Trial Registration ClinicalTrials.gov NCT01350063 PMID:25816342

Assessment and Implication of Prognostic Imbalance in Randomized Controlled Trials with a Binary Outcome – A Simulation Study

PubMed Central

Chu, Rong; Walter, Stephen D.; Guyatt, Gordon; Devereaux, P. J.; Walsh, Michael; Thorlund, Kristian; Thabane, Lehana

2012-01-01

Background Chance imbalance in baseline prognosis of a randomized controlled trial can lead to over or underestimation of treatment effects, particularly in trials with small sample sizes. Our study aimed to (1) evaluate the probability of imbalance in a binary prognostic factor (PF) between two treatment arms, (2) investigate the impact of prognostic imbalance on the estimation of a treatment effect, and (3) examine the effect of sample size (n) in relation to the first two objectives. Methods We simulated data from parallel-group trials evaluating a binary outcome by varying the risk of the outcome, effect of the treatment, power and prevalence of the PF, and n. Logistic regression models with and without adjustment for the PF were compared in terms of bias, standard error, coverage of confidence interval and statistical power. Results For a PF with a prevalence of 0.5, the probability of a difference in the frequency of the PF≥5% reaches 0.42 with 125/arm. Ignoring a strong PF (relative risk = 5) leads to underestimating the strength of a moderate treatment effect, and the underestimate is independent of n when n is >50/arm. Adjusting for such PF increases statistical power. If the PF is weak (RR = 2), adjustment makes little difference in statistical inference. Conditional on a 5% imbalance of a powerful PF, adjustment reduces the likelihood of large bias. If an absolute measure of imbalance ≥5% is deemed important, including 1000 patients/arm provides sufficient protection against such an imbalance. Two thousand patients/arm may provide an adequate control against large random deviations in treatment effect estimation in the presence of a powerful PF. Conclusions The probability of prognostic imbalance in small trials can be substantial. Covariate adjustment improves estimation accuracy and statistical power, and hence should be performed when strong PFs are observed. PMID:22629322

SIDE TO SIDE DIFFERENCES BETWEEN DOMINANT AND NON-DOMINANT ARM’S BONE DENSITY AND ISOMETRIC HANDGRIP STRENGTH IN MALES AND FEMALES AGED 40-65 YEARS OLD

PubMed Central

Krasniqi, Ermira; Koni, Mynyr; Kabashi, Antigona; Bahtiri, Abedin; Gjeli, Selda; Boshnjaku, Arben

2016-01-01

Objective: This observational, cross-sectional study, investigates and compares the differences of BMD, T-score, Z-score and isometric strength between dominant (D) versus non-dominant (ND) arms of 162 subjects aged 40-65 in a developing, low income country (Kosova). Material and Methods: Bone Mineral Density (BMD), T-score and Z-score at distal forearm regions of both arms (measured by DXA scan), together with the Handgrip Isometric Strength (HIS) (by handgrip) were evaluated in a total subjects (53 Males and 109 Females). Additionally, General Healthcare Status Questionnaire together with self-administrated International Physical Activity Questionnaire (IPAQ) were filled. Results: Significant differences (p<0.05) between arms were found in BMD, T-score, and Z-score in total subjects and in females, whereas not significant differences (p>0.05) were observed in Males BMD comparing to significantly higher results (p<0.05) in T-score and Z-score. Significant differences (p<0.05) were also found in total subjects and in females handgrip, but not (p>0.05) in males. When comparing the total subject’s BMD, T-score, Z-score and Handgrip based on the PA levels (1 to 3 according to IPAQ scoring) no significant differences (p>0.05) were found between PA1, as well as PA3 whereas significantly differences (p<0.05) were found in D arms of PA2 level. Conclusion: The study analyses side-to-side differences in bone density and muscular force between D and ND arms amongst a population which is frequently exposed to diagnostic screenings for age related osteomuscular conditions (aged 40-60), and demonstrates that these differences should be in consideration amongst clinicians, but not in the way it is done right now. PMID:27999479

Effectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: A randomized controlled trial

PubMed Central

Post, Erik; Brandsma, Wim; Bowers, Bob; Alam, Khorshed; Shetty, Vanaja; Pai, Vivek; Husain, Sajid; Sigit Prakoeswa, Cita Rosita; Astari, Linda; Hagge, Deanna; Shah, Mahesh; Neupane, Kapil; Tamang, Krishna Bahadur; Nicholls, Peter; Richardus, Jan Hendrik

2017-01-01

Background While prednisolone is commonly used to treat recent nerve function impairment (NFI) in leprosy patients, the optimal treatment duration has not yet been established. In this “Treatment of Early Neuropathy in Leprosy” (TENLEP) trial, we evaluated whether a 32-week prednisolone course is more effective than a 20-week course in restoring and improving nerve function. Methods In this multi-centre, triple-blind, randomized controlled trial, leprosy patients who had recently developed clinical NFI (<6 months) were allocated to a prednisolone treatment regimen of either 20 weeks or 32 weeks. Prednisolone was started at either 45 or 60 mg/day, depending on the patient’s body weight, and was then tapered. Throughout follow up, NFI was assessed by voluntary muscle testing and monofilament testing. The primary outcome was the proportion of patients with improved or restored nerve function at week 78. As secondary outcomes, we analysed improvements between baseline and week 78 on the Reaction Severity Scale, the SALSA Scale and the Participation Scale. Serious Adverse Events and the need for additional prednisolone treatment were monitored and reported. Results We included 868 patients in the study, 429 in the 20-week arm and 439 in the 32-week arm. At 78 weeks, the proportion of patients with improved or restored nerve function did not differ significantly between the groups: 78.1% in the 20-week arm and 77.5% in the 32-week arm (p = 0.821). Nor were there any differences in secondary outcomes, except for a significant higher proportion of Serious Adverse Events in the longer treatment arm. Conclusion In our study, a 20-week course of prednisolone was as effective as a 32-week course in improving and restoring recent clinical NFI in leprosy patients. Twenty weeks is therefore the preferred initial treatment duration for leprosy neuropathy, after which likely only a minority of patients require further individualized treatment. PMID:28976976

Review of the randomized clinical stroke rehabilitation trials in 2009

PubMed Central

Rabadi, Meheroz H.

2011-01-01

Summary Background Recent review of the available evidence on interventions for motor recovery after stroke, showed that improvements in recovery of arm function were seen for constraint-induced movement therapy, electromyographic biofeedback, mental practice with motor imagery, and robotics. Similar improvement in transfer ability or balance were seen with repetitive task training, biofeedback, and training with a moving platform. Walking speed was improved by physical fitness training, high-intensity physiotherapy and repetitive task training. However, most of these trials were small and had design limitations. Material/Methods In this article, randomized control trials (RCT’s) published in 2009 of rehabilitation therapies for acute (≤2 weeks), sub-acute (2 to 12 weeks) and chronic (≥12 weeks) stroke was reviewed. A Medline search was performed to identify all RCT’s in stroke rehabilitation in the year 2009. The search strategy that was used for PubMed is presented in the Appendix 1. The objective was to examine the effectiveness of these treatment modalities in stroke rehabilitation. Results This generated 35 RCT’s under 5 categories which were found and analyzed. The methodological quality was assessed by using the PEDro scale for external and internal validity. Conclusions These trials were primarily efficacy studies. Most of these studies enrolled small numbers of patient which precluded their clinical applicability (limited external validity). However, the constraint induced movement therapy (CIT), regularly used in chronic stroke patients did not improve affected arm-hand function when used in acute stroke patients at ≤4 weeks. Intensive CIT did not lead to motor improvement in arm-hand function. Robotic arm treatment helped decrease motor impairment and improved function in chronic stroke patients only. Therapist provided exercise programs (when self-administered by patients during their off-therapy time in a rehabilitation setting) did improve arm-hand function. Tai Chi exercises helped improve balance and weight bearing. Exercise programs for community dwelling stroke patient helped maintain and even improve their functional state. PMID:21278702

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

Safety data from the phase III Japanese ACHIEVE trial: part of an international, prospective, planned pooled analysis of six phase III trials comparing 3 versus 6 months of oxaliplatin-based adjuvant chemotherapy for stage III colon cancer

PubMed Central

Kotaka, Masahito; Yamanaka, Takeharu; Yoshino, Takayuki; Manaka, Dai; Eto, Tetsuya; Hasegawa, Junichi; Takagane, Akinori; Nakamura, Masato; Kato, Takeshi; Munemoto, Yoshinori; Nakamura, Fumitaka; Bando, Hiroyuki; Taniguchi, Hiroki; Gamoh, Makio; Shiozawa, Manabu; Saji, Shigetoyo; Maehara, Yoshihiko; Mizushima, Tsunekazu; Ohtsu, Atsushi; Mori, Masaki

2018-01-01

Background The International Duration Evaluation of Adjuvant chemotherapy project investigated whether a shorter duration of oxaliplatin-based adjuvant chemotherapy was as effective as 6 months of identical chemotherapy for resected stage III colon cancer. As part of this project, we report safety data from the Japanese ACHIEVE study (JFMC47-1202-C3). Patients and methods ACHIEVE was an open-label, multicentre trial randomising patients with stage III colon cancer to receive 3 m or 6 m of mFOLFOX6/CAPOX after surgery. Choice of regimen was declared before randomisation by a site investigator. Results Between August 2012 and June 2014, 1313 patients were enrolled and, of those, 1277 were analysed for the safety analysis, with 635 in arm 6 (mFOLFOX6, n=158; CAPOX, n=477) and 642 in arm 3 (mFOLFOX6, n=161; CAPOX, n=481). Grade 3 or worse peripheral sensory neuropathy (PSN) developed in 5%/0.6% of patients receiving mFOLFOX6 in arm 6/3 (p=0.019) and 6%/1% of those receiving CAPOX in arm 6/3 (p<0.001). Similarly, grade 2 or worse PSN developed in 36%/11% of patients receiving mFOLFOX6 in arm 6/3 (p<0.001) and 37%/14% of those receiving CAPOX in arm 6/3 (p<0.001). An association between baseline creatinine clearance (CCr) and adverse events (AEs) was found that patients with CAPOX were significantly more likely to develop AEs ≥grade 3 when they had a CCr ≤50 (OR 1.67; p=0.048). Conclusions We confirmed in the Japanese population that the shorter duration of adjuvant chemotherapy resulted in a significant reduction of PSN. In patients with CAPOX, renal function was significantly related to severe AEs. Trial registration number UMIN000008543, Results. PMID:29713499

Primary Analysis of a Phase II Randomized Trial Radiation Therapy Oncology Group (RTOG) 0212: Impact of Different Total Doses and Schedules of Prophylactic Cranial Irradiation on Chronic Neurotoxicity and Quality of Life for Patients With Limited-Disease Small-Cell Lung Cancer

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

Wolfson, Aaron H., E-mail: awolfson@med.miami.edu; Bae, Kyounghwa; Komaki, Ritsuko

2011-09-01

Purpose: To determine the effect of dose and fractionation schedule of prophylactic cranial irradiation (PCI) on the incidence of chronic neurotoxicity (CNt) and changes in quality of life for selected patients with limited-disease small-cell lung cancer (LD SCLC). Methods and Materials: Patients with LD SCLC who achieved a complete response after chemotherapy and thoracic irradiation were eligible for randomization to undergo PCI to a total dose of 25 Gy in 10 daily fractions (Arm 1) vs. the experimental cohort of 36 Gy. Those receiving 36 Gy underwent a secondary randomization between daily 18 fractions (Arm 2) and twice-daily 24 fractionsmore » (Arm 3). Enrolled patients participated in baseline and follow-up neuropsychological test batteries along with quality-of-life assessments. Results: A total of 265 patients were accrued, with 131 in Arm 1, 67 in Arm 2, and 66 in Arm 3 being eligible. There are 112 patients (42.2%) alive with 25.3 months of median follow-up. There were no significant baseline differences among groups regarding quality-of-life measures and one of the neuropsychological tests, namely the Hopkins Verbal Learning Test. However, at 12 months after PCI there was a significant increase in the occurrence of CNt in the 36-Gy cohort (p = 0.02). Logistic regression analysis revealed increasing age to be the most significant predictor of CNt (p = 0.005). Conclusions: Because of the increased risk of developing CNt in study patients with 36 Gy, a total PCI dose of 25 Gy remains the standard of care for patients with LD SCLC attaining a complete response to initial chemoradiation.« less

The Appropriateness of the Length of Insulin Needles Based on Determination of Skin and Subcutaneous Fat Thickness in the Abdomen and Upper Arm in Patients with Type 2 Diabetes

PubMed Central

Sim, Kang Hee; Kim, Sun Young; Lee, Hye Mi; Chang, Ji Yeun; Lee, Moon Kyu

2014-01-01

Background Longer needle and complicated insulin injection technique such as injecting at a 45-degree angle and making skinfolds may decrease patient compliance to insulin injection therapy. In this light, shorter insulin needles have been recently developed. However, it is necessary to ascertain that such shorter needles are appropriate for Korean patients with diabetes as well. Methods First, the diverse demographic and diabetic features of 156 Korean adults with diabetes were collected by a questionnaire and a device unit of body fat measurement. The skin and subcutaneous fat thicknesses of each subject were measured by Ultrasound device with a 7- to 12-MHz probe. Data were analyzed using analysis of variance and multiple linear regression. Results The mean skin thickness was 2.29±0.37 mm in the abdomen and 2.00±0.34 mm in the upper arms, and the mean subcutaneous fat thickness was to 10.15±6.54 mm in the abdomen and 5.50±2.68 mm in the upper arms. Our analysis showed that the factors affecting the skin thickness of the abdomen and upper arms were gender and body mass index (BMI), whereas the factors influencing the subcutaneous fat thickness in the abdomen were gender and BMI, and the factors influencing the subcutaneous fat thickness in the upper arms were gender, BMI, and age. Insulin fluids may not appear to be intradermally injected into the abdomen and upper arms at any needle lengths. The risk of intramuscular injection is likely to increase with longer insulin needles and lower BMI. Conclusion It is recommended to fully inform the patients about the lengths of needles for insulin injections. As for the recommended needle length, the findings of this study indicate that needles as short as 4 mm are sufficient to deliver insulin for Korean patients with diabetes. PMID:24851206

Dose-Dense Temozolomide for Newly Diagnosed Glioblastoma: A Randomized Phase III Clinical Trial

PubMed Central

Gilbert, Mark R.; Wang, Meihua; Aldape, Kenneth D.; Stupp, Roger; Hegi, Monika E.; Jaeckle, Kurt A.; Armstrong, Terri S.; Wefel, Jeffrey S.; Won, Minhee; Blumenthal, Deborah T.; Mahajan, Anita; Schultz, Christopher J.; Erridge, Sara; Baumert, Brigitta; Hopkins, Kristen I.; Tzuk-Shina, Tzahala; Brown, Paul D.; Chakravarti, Arnab; Curran, Walter J.; Mehta, Minesh P.

2013-01-01

Purpose Radiotherapy with concomitant and adjuvant temozolomide is the standard of care for newly diagnosed glioblastoma (GBM). O6-methylguanine-DNA methyltransferase (MGMT) methylation status may be an important determinant of treatment response. Dose-dense (DD) temozolomide results in prolonged depletion of MGMT in blood mononuclear cells and possibly in tumor. This trial tested whether DD temozolomide improves overall survival (OS) or progression-free survival (PFS) in patients with newly diagnosed GBM. Patients and Methods This phase III trial enrolled patients older than age 18 years with a Karnofsky performance score of ≥ 60 with adequate tissue. Stratification included clinical factors and tumor MGMT methylation status. Patients were randomly assigned to standard temozolomide (arm 1) or DD temozolomide (arm 2) for 6 to 12 cycles. The primary end point was OS. Secondary analyses evaluated the impact of MGMT status. Results A total of 833 patients were randomly assigned to either arm 1 or arm 2 (1,173 registered). No statistically significant difference was observed between arms for median OS (16.6 v 14.9 months, respectively; hazard ratio [HR], 1.03; P = .63) or median PFS (5.5 v 6.7 months; HR, 0.87; P = .06). Efficacy did not differ by methylation status. MGMT methylation was associated with improved OS (21.2 v 14 months; HR, 1.74; P < .001), PFS (8.7 v 5.7 months; HR, 1.63; P < .001), and response (P = .012). There was increased grade ≥ 3 toxicity in arm 2 (34% v 53%; P < .001), mostly lymphopenia and fatigue. Conclusion This study did not demonstrate improved efficacy for DD temozolomide for newly diagnosed GBM, regardless of methylation status. However, it did confirm the prognostic significance of MGMT methylation. Feasibility of large-scale accrual, prospective tumor collection, and molecular stratification was demonstrated. PMID:24101040

Inter-arm Differences in Simultaneous Blood Pressure Measurements in Ambulatory Patients without Cardiovascular Diseases

PubMed Central

Kim, Kyoung Bog; Kim, Haa Gyoung; Ki, Ji Hoon; Lee, Soo Hee; Kim, Su Min

2013-01-01

Background It has traditionally been known that there is normally a difference in blood pressure (BP) between the two arms; there is at least 20 mm Hg difference in the systolic blood pressure (SBP) and 10 mm Hg difference in the diastolic blood pressure (DBP). However, recent epidemiologic studies have shown that there are between-arm differences of < 5 mm Hg in simultaneous BP measurements. The purposes of this study is to examine whether there are between-arm differences in simultaneous BP measurements obtained from ambulatory patients without cardiovascular diseases and to identify the factors associated these differences. Methods We examined 464 patients who visited the outpatient clinic of Gangneung Asan Hospital clinical department. For the current analysis, we excluded patients with ischemic heart disease, stroke, arrhythmia, congestive heart failure, or hyperthyroidism. Simultaneous BP measurements were obtained using the Omron MX3 BP monitor in both arms. The inter-arm difference (IAD) in BP was expressed as the relative difference (right-arm BP [R] minus left-arm BP [L]: R - L) and the absolute difference (|R - L|). Results The mean absolute IAD in SBP and DBP were 3.19 ± 2.38 and 2.41 ± 1.59 mm Hg, respectively, in men and 2.61 ± 2.18 and 2.25 ± 2.01 mm Hg, respectively, in women. In men, there were 83.8% of patients with the IAD in SBP of ≤ 6 mm Hg, 98.1% with the IAD in SBP of ≤ 10 mm Hg, 96.5% with the IAD in DBP of ≤ 6 mm Hg and 0% with the IAD in DBP of > 10 mm Hg. In women, 89.6% of patients had IAD in SBP of ≤ 6 mm Hg, 92.1% with IAD in DBP of ≤ 6 mm Hg, and 0% with IAD in SBP of > 10 mm Hg or IAD in DBP of > 10 mm Hg. Gangneung Asan Hospital clinical series of patients showed that the absolute IAD in SBP had a significant correlation with cardiovascular risk factors such as the 10-year Framingham cardiac risk scores and higher BP in men and higher BP in women. However, the absolute IAD in SBP and DBP had no significant correlation with the age, obesity, smoking, drinking, hyperlipidemia, diabetes, metabolic syndrome, and renal function. Conclusion Our results showed that there were no significant between-arm differences in simultaneous BP measurements. It was also shown that most of the ambulatory patients without cardiovascular diseases had an IAD in SBP of < 10 mm Hg and an IAD in DBP of < 6 mm Hg. PMID:23560208

Six Months of Diazoxide Treatment at Bedtime in Newly Diagnosed Subjects With Type 1 Diabetes Does Not Influence Parameters of β-Cell Function and Autoimmunity but Improves Glycemic Control

PubMed Central

Radtke, Maria Anita; Nermoen, Ingrid; Kollind, Magnus; Skeie, Svein; Sørheim, Jan Inge; Svartberg, Johan; Hals, Ingrid; Moen, Torolf; Dørflinger, Gry Høst; Grill, Valdemar

2010-01-01

OBJECTIVE Continuous β-cell rest with diazoxide preserves residual endogenous insulin production in type 1 diabetes. However, side effects have hampered therapeutic usefulness. In a double-blind study, we tested whether lower, intermittent dosing of diazoxide had beneficial effects on insulin production, metabolic control, and autoimmunity markers in the absence of side effects. RESEARCH DESIGN AND METHODS Forty-one newly diagnosed type 1 diabetic patients were randomized to 6 months of treatment with placebo or 100 mg diazoxide at bedtime. A1C, C-peptide (fasting and glucagon stimulated), and FoxP3+ regulatory T-cells (Tregs) were measured. Patients were followed for 6 months after intervention. RESULTS Of six dropouts, three were due to perceived side effects; one subject in the diazoxide group experienced rash, another dizziness, and one in the placebo group sleep disturbance. Adverse effects in others were absent. Diazoxide treatment reduced A1C from 8.6% at baseline to 6.0% at 6 months and 6.5% at 12 months. Corresponding A1C value in the placebo arm were 8.3, 7.3, and 7.5% (P < 0.05 for stronger reduction in the diazoxide group). Fasting and stimulated C-peptide decreased during 12 months similarly in both arms (mean −0.30 and −0.18 nmol/l in the diazoxide arm and −0.08 and −0.09 nmol/l in the placebo arm). The proportion of Tregs was similar in both arms and remained stable during intervention but was significantly lower compared with nondiabetic subjects. CONCLUSIONS Six months of low-dose diazoxide was without side effects and did not measurably affect insulin production but was associated with improved metabolic control. PMID:20028939

Menstrual History and Quality-of-Life Outcomes in Women With Node-Positive Breast Cancer Treated With Adjuvant Therapy on the NSABP B-30 Trial

PubMed Central

Ganz, Patricia A.; Land, Stephanie R.; Geyer, Charles E.; Cecchini, Reena S.; Costantino, Joseph P.; Pajon, Eduardo R.; Fehrenbacher, Louis; Atkins, James N.; Polikoff, Jonathan A.; Vogel, Victor G.; Erban, John K.; Livingston, Robert B.; Perez, Edith A.; Mamounas, Eleftherios P.; Wolmark, Norman; Swain, Sandra M.

2011-01-01

Purpose Premenopausal women with breast cancer receiving adjuvant chemotherapy are at risk for amenorrhea. The National Surgical Adjuvant Breast and Bowel Project B-30 trial included menstrual history (MH) and quality-of-life (QOL) studies to compare treatments on these outcomes. Patients and Methods Patients were randomly assigned to sequential doxorubicin (A) and cyclophosphamide (C) followed by docetaxel (T; AC→T), concurrent TAC, or AT, which varied in duration (24, 12, 12 weeks, respectively), and use of C. Endocrine therapy was prescribed for women with hormone receptor–positive tumors. MH and QOL were assessed with standardized questionnaires at baseline; cycle 4, day 1; and every 6 months through 24 months. Prespecified analyses examined rates of amenorrhea by treatment arm, the relationship between amenorrhea and QOL, and QOL by treatment arm. Results Amenorrhea 12 months after random assignment was significantly different between treatment groups: 69.8% for AC→T, 57.7% for TAC, and 37.9% for AT (P < .001). The AT group without tamoxifen had the lowest rate of amenorrhea. QOL was poorer for patients receiving AC→T at 6 months but similar to others by 12 months. Post-treatment symptoms were increased above baseline for all treatments. Multivariable repeated measures modeling demonstrated that treatment arm, time point, age, and tamoxifen use were significantly associated with symptom severity (all P values < .002). Conclusion Amenorrhea rates differed significantly by treatment arm, with the AT arm having the lowest rate. Patients treated with longer duration therapy (AC→T) had greater symptom severity and poorer QOL at 6 months, but did not differ from shorter duration treatments at 12 months. PMID:21300930

Patient-Reported Outcomes in Sentinel Node–Negative Adjuvant Breast Cancer Patients Receiving Sentinel-Node Biopsy or Axillary Dissection: National Surgical Adjuvant Breast and Bowel Project Phase III Protocol B-32

PubMed Central

Land, Stephanie R.; Kopec, Jacek A.; Julian, Thomas B.; Brown, Ann M.; Anderson, Stewart J.; Krag, David N.; Christian, Nicholas J.; Costantino, Joseph P.; Wolmark, Norman; Ganz, Patricia A.

2010-01-01

Purpose Sentinel lymph node resection (SNR) may reduce morbidity while providing the same clinical utility as conventional axillary dissection (AD). National Surgical Adjuvant Breast and Bowel Project (NSABP) B-32 is a randomized phase III trial comparing SNR immediately followed by AD (SNAD) to SNR and subsequent AD if SN is positive. We report the definitive patient-reported outcomes (PRO) comparisons. Patients and Methods Eligible patients had clinically node-negative, operable invasive breast cancer. The PRO substudy included all SN-negative participants enrolled May 2001 to February 2004 at community institutions in the United States (n = 749; 78% age ≥ 50; 87% clinical tumor size ≤ 2.0 cm; 84% lumpectomy; 87% white). They completed questionnaires presurgery, 1 and 2 to 3 weeks postoperatively, and every 6 months through year 3. Arm symptoms, arm use avoidance, activity limitations, and quality of life (QOL) were compared with intent-to-treat two-sample t-tests and repeated measures analyses. Results Arm symptoms were significantly more bothersome for SNAD compared with SNR patients at 6 months (mean, 4.8 v 3.0; P < .001) and at 12 months (3.6 v 2.5; P = .006). Longitudinally, SNAD patients were more likely to experience ipsilateral arm and breast symptoms, restricted work and social activity, and impaired QOL (P ≤ .002 all items). From 12 to 36 months, fewer than 15% of either SNAD or SNR patients reported moderate or greater severity of any given symptom or activity limitation. Conclusion Arm morbidity was greater with SNAD than with SNR. Despite considerable fears about complications from AD for breast cancer, this study demonstrates that initial problems with either surgery resolve over time. PMID:20679600

Patient-reported outcomes in a phase iii study of everolimus versus placebo in patients with metastatic carcinoma of the kidney that has progressed on vascular endothelial growth factor receptor tyrosine kinase inhibitor therapy.

PubMed

Beaumont, Jennifer L; Butt, Zeeshan; Baladi, Jeanfrancois; Motzer, Robert J; Haas, Tomas; Hollaender, Norbert; Kay, Andrea; Cella, David

2011-01-01

A phase III, randomized, double-blind, placebo-controlled trial was conducted in patients with metastatic renal cell carcinoma. The focus of this paper is to evaluate the patient-reported outcomes. Patients were randomly assigned (2:1) to receive oral everolimus 10 mg once daily or placebo. The Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease-Related Symptoms (FKSI-DRS) and European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 were administered before randomization and on day 1 of each cycle. The FKSI-DRS and the EORTC QLQ-C30 Physical Functioning and Global Quality of Life scores were the primary endpoints examined. Longitudinal models were used to compare treatment arms. Sensitivity analyses were conducted to explore the impact of missing data assumptions. Longitudinal trends for FKSI-DRS scores did not differ by treatment arm. Taking nonignorable missing data into account, there were significant differences between treatment arms in the trend over time for physical functioning and global quality of life, with the everolimus arm exhibiting greater decreases. All three of these measures of health-related quality of life were significantly related to progression-free survival. There was no evidence of a difference between everolimus and placebo in longitudinal patterns of disease-related symptoms, and little difference between the arms in physical functioning or global quality of life trends. This supports the conclusion that delay in tumor progression demonstrated by everolimus is associated with minimal impact on symptoms, physical functioning, or quality of life, as reported by patients.

Effects of a Problem-Solving Intervention (COPE) on Quality of Life for Patients with Advanced Cancer on Clinical Trials and their Caregivers: Simultaneous Care Educational Intervention (SCEI): Linking Palliation and Clinical Trials

PubMed Central

Carducci, Michael; Loscalzo, Matthew J.; Linder, John; Greasby, Tamara; Beckett, Laurel A.

2011-01-01

Abstract Context Patients on investigational clinical trials and their caregivers experience poor quality of life (QOL), which declines as the disease progresses. Objective To examine the effect of a standardized cognitive–behavioral problem-solving educational intervention on the QOL of patients enrolled on investigational clinical trials and their caregivers. Design Prospective, multi-institution, randomized trial. QOL was measured repeatedly over 6 months. Participants Patients were simultaneously enrolled onto phase 1, 2, or 3 Institutional Review Board (IRB)-approved cancer clinical trials. Intervention Intervention arm dyads participated in three conjoint educational sessions during the first month, learning the COPE problem solving model. Nonintervention arm dyads received usual care. Outcome Measures Global QOL was measured by the City of Hope Quality of Life Instruments for Patients or Caregivers; problem solving skills were measured by the Social Problem Solving Inventory-Revised. Results The results are reported using the CONSORT statement. The analytic data set included 476 dyads including 1596 patient data points and 1576 care giver data points. Patient QOL showed no significant difference in the rate of change between the intervention and usual care arms (p = 0.70). Caregiver QOL scores in the intervention arm declined, but at less than half the rate in the control arm (p = 0.02). Conclusions The COPE intervention enabled the average caregiver to come much closer to stable QOL over the 6-month follow-up. Future studies should enroll subjects much earlier in the cancer illness trajectory, a common patient/caregiver theme. The maximum effect was seen in caregivers who completed the 6-month follow-up, suggesting that the impact may increase over time. PMID:21413846

3D model for Cancerous Inhibitor of Protein Phosphatase 2A armadillo domain unveils highly conserved protein-protein interaction characteristics.

PubMed

Dahlström, Käthe M; Salminen, Tiina A

2015-12-07

Cancerous Inhibitor of Protein Phosphatase 2A (CIP2A) is a human oncoprotein, which exerts its cancer-promoting function through interaction with other proteins, for example Protein Phosphatase 2A (PP2A) and MYC. The lack of structural information for CIP2A significantly prevents the design of anti-cancer therapeutics targeting this protein. In an attempt to counteract this fact, we modeled the three-dimensional structure of the N-terminal domain (CIP2A-ArmRP), analyzed key areas and amino acids, and coupled the results to the existing literature. The model reliably shows a stable armadillo repeat fold with a positively charged groove. The fact that this conserved groove highly likely binds peptides is corroborated by the presence of a conserved polar ladder, which is essential for the proper peptide-binding mode of armadillo repeat proteins and, according to our results, several known CIP2A interaction partners appropriately possess an ArmRP-binding consensus motif. Moreover, we show that Arg229Gln, which has been linked to the development of cancer, causes a significant change in charge and surface properties of CIP2A-ArmRP. In conclusion, our results reveal that CIP2A-ArmRP shares the typical fold, protein-protein interaction site and interaction patterns with other natural armadillo proteins and that, presumably, several interaction partners bind into the central groove of the modeled CIP2A-ArmRP. By providing essential structural characteristics of CIP2A, the present study significantly increases our knowledge on how CIP2A interacts with other proteins in cancer progression and how to develop new therapeutics targeting CIP2A. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

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

HIV salvage therapy does not require nucleoside reverse transcriptase inhibitors: a randomized trial

PubMed Central

Tashima, Karen T; Smeaton, Laura M; Fichtenbaum, Carl J; Andrade, Adriana; Eron, Joseph J; Gandhi, Rajesh T; Johnson, Victoria A; Klingman, Karin L; Ritz, Justin; Hodder, Sally; Santana, Jorge L; Wilkin, Timothy; Haubrich, Richard H

2015-01-01

Background Nucleoside reverse transcriptase inhibitors (NRTIs) are often included in antiretroviral (ARV) regimens in treatment-experienced patients in the absence of data from randomized trials. Objective To compare treatment success between participants who omit versus Add NRTIs to an optimized ARV regimen of three or more agents. Design Multisite, randomized, controlled trial. Setting Outpatient HIV clinics. Participants HIV-infected patients with three-class ARV experience and/or viral resistance. Intervention Open-label optimized regimens (not including NRTIs) were selected based upon treatment history and susceptibility testing. Participants were randomized to Omit or Add NRTIs. Measurements The primary efficacy outcome was regimen failure through week 48, using a non-inferiority margin of 15%. The primary safety outcome was time to initial episode of severe sign/symptom or laboratory abnormality prior to discontinuation of NRTI assignment. Results 360 participants were randomized and 93% completed a week 48 visit. The cumulative probability of regimen failure was 29.8% in the Omit NRTI arm versus 25.9% in the Add NRTI arm (difference= 3.2%: 95% CI, −6.1 to 12.5). There were no significant differences in the primary safety endpoints or the proportion of participants with HIV RNA <50 copies/mL between arms. No deaths occurred in the Omit NRTIs arm, compared with 7 deaths in the Add NRTIs arm. Limitations Non-blinded study design and may not be applicable to resource poor settings. Conclusion HIV-infected treatment-experienced patients starting a new optimized regimen can safely omit NRTIs without compromising virologic efficacy. Omitting NRTIs will reduce pill burden, cost, and toxicity in this patient population. PMID:26595748

Association of body flexibility and carotid atherosclerosis in Japanese middle-aged men: a cross-sectional study

PubMed Central

Imoto, Takayuki; Kida, Akira; Yokochi, Takashi; Iwase, Mitsunori; Kozawa, Kenji

2018-01-01

Objective This study examined the associations of body flexibility with carotid arterial remodelling, including intima–media thickness (IMT) and plaque formation in middle-aged men. Methods The subjects of this cross-sectional study included 1354 Japanese men aged 35–59 years without histories of stroke or cardiac diseases. The arm extensibility test, which can estimate flexibility of the upper extremity (composed of shoulder external rotation and forearm supination), and the sit-and-reach test were performed. Common carotid IMT and plaque formation (≥1.1 mm) were estimated by ultrasound. Results The proportion of subjects who fully completed the arm extensibility test was 55.0%, and who had plaques in the common carotid artery was 37.8%. IMT was associated with poor arm extensibility (β=–0.073, 95% CI –0.02224 to –0.00041, P=0.004), while plaque formation was associated with poor sit-and-reach (OR 0.98579, 95% CI 0.97257 to 0.99919, P=0.038) after adjustment by all covariates. Conclusions This study demonstrated that poor upper extremity and trunk flexibility were associated with characteristics of early onset of atherosclerosis. Furthermore, these associations were independent of covariates such as age, blood pressure, blood lipids glucose levels and abdominal fat accumulation, handgrip strength and lifestyle, including sleeping, drinking, exercise and smoking habits. Poor flexibility may reflect subclinical atherosclerosis in middle-aged men. PMID:29306892

Rb1 loss modifies but does not initiate alveolar rhabdomyosarcoma

PubMed Central

2013-01-01

Background Alveolar rhabdomyosarcoma (aRMS) is a myogenic childhood sarcoma frequently associated with a translocation-mediated fusion gene, Pax3:Foxo1a. Methods We investigated the complementary role of Rb1 loss in aRMS tumor initiation and progression using conditional mouse models. Results Rb1 loss was not a necessary and sufficient mutational event for rhabdomyosarcomagenesis, nor a strong cooperative initiating mutation. Instead, Rb1 loss was a modifier of progression and increased anaplasia and pleomorphism. Whereas Pax3:Foxo1a expression was unaltered, biomarkers of aRMS versus embryonal rhabdomyosarcoma were both increased, questioning whether these diagnostic markers are reliable in the context of Rb1 loss. Genome-wide gene expression in Pax3:Foxo1a,Rb1 tumors more closely approximated aRMS than embryonal rhabdomyosarcoma. Intrinsic loss of pRb function in aRMS was evidenced by insensitivity to a Cdk4/6 inhibitor regardless of whether Rb1 was intact or null. This loss of function could be attributed to low baseline Rb1, pRb and phospho-pRb expression in aRMS tumors for which the Rb1 locus was intact. Pax3:Foxo1a RNA interference did not increase pRb or improve Cdk inhibitor sensitivity. Human aRMS shared the feature of low and/or heterogeneous tumor cell pRb expression. Conclusions Rb1 loss from an already low pRb baseline is a significant disease modifier, raising the possibility that some cases of pleomorphic rhabdomyosarcoma may in fact be Pax3:Foxo1a-expressing aRMS with Rb1 or pRb loss of function. PMID:24274149

A relative difference in systolic blood pressure between arms by synchronal measurement and conventional cardiovascular risk factors are associated with the severity of coronary atherosclerosis.

PubMed

Yamamoto, Tomohiko; Miura, Shin-Ichiro; Suematsu, Yasunori; Kuwano, Takashi; Sugihara, Makoto; Ike, Amane; Iwata, Atsushi; Nishikawa, Hiroaki; Saku, Keijiro

2016-06-01

It is not known the relationships between a difference in systolic blood pressure (SBP) or diastolic BP (DBP) between arms by synchronal measurement and the presence of coronary artery disease (CAD), and between a difference in BP between arms and the severity of coronary atherosclerosis. We enrolled 425 consecutive patients (M/F = 286/139, 67 ± 13 year) who were admitted to our University Hospital and in whom we could measure the absolute (|rt. BP - lt. BP|) and relative (rt. BP - lt. BP) differences in SBP and DBP using a nico PS-501(®) (Parama-Tech). We divided all patients into those who did and did not have CAD. The relative differences in SBP between arms in patients with CAD were significantly lower than those in patients without CAD. However, the relative difference in SBP between arms was not a predictor of the presence of CAD. We also divided 267 patients who underwent coronary angiography into tertiles according to the Gensini score (low, middle, and high score groups). Interestingly, the middle + high score groups showed significantly lower relative differences in SBP between arms than the low score group. The mean Korotkoff sound graph in the middle + high Gensini score group was significantly higher than that in the low Gensini score group. Among conventional cardiovascular risk factors and nico parameters, the relative difference in SBP between arms in addition to the risk factors (age, gender, body mass index, hypertension, dyslipidemia, and diabetes mellitus) was associated with the score by a logistic regression analysis. In conclusion, the relative difference in SBP between arms as well as conventional risk factors may be associated with the severity of coronary arteriosclerosis.

Upper Arm Central Venous Port Implantation: A 6-Year Single Institutional Retrospective Analysis and Pictorial Essay of Procedures for Insertion

PubMed Central

Shiono, Masatoshi; Takahashi, Shin; Kakudo, Yuichi; Takahashi, Masanobu; Shimodaira, Hideki; Kato, Shunsuke; Ishioka, Chikashi

2014-01-01

Background The requirement of central venous (CV) port implantation is increasing with the increase in the number of cancer patients and advancement in chemotherapy. In our division, medical oncologists have implanted all CV ports to save time and consultation costs to other departments. Recently, upper arm implantation has become the first choice as a safe and comfortable method in our unit. Here we report our experience and discuss the procedure and its potential advantages. Methods All CV port implantations (n = 599) performed in our unit from January 2006 to December 2011 were analyzed. Procedural success and complication rates between subclavian and upper arm groups were compared. Results Both groups had similar patient characteristics. Upper arm CV port and subclavian implantations were equivalently successful and safe. Although we only retrospectively analyzed data from a single center, the upper arm group had a significantly lower overall postprocedural complication rate than the subclavian group. No pneumothorax risk, less risk of arterial puncture by ultrasound, feasibility of stopping potential arterial bleeding, and prevention of accidental arterial cannulation by targeting the characteristic solitary basilic vein were the identified advantages of upper arm CV port implantation. In addition to the aforementioned advantages, there is no risk of “pinch-off syndrome,” possibly less patient fear of manipulation, no scars on the neck and chest, easier accessibility, and compatibility with the “peripherally inserted central catheter” technique. Conclusions Upper arm implantation may benefit clinicians and patients with respect to safety and comfort. We also introduce our methods for upper arm CV port implantation with the videos. PMID:24614412

2D–3D radiograph to cone-beam computed tomography (CBCT) registration for C-arm image-guided robotic surgery

PubMed Central

Liu, Wen Pei; Otake, Yoshito; Azizian, Mahdi; Wagner, Oliver J.; Sorger, Jonathan M.; Armand, Mehran; Taylor, Russell H.

2015-01-01

Purpose C-arm radiographs are commonly used for intraoperative image guidance in surgical interventions. Fluoroscopy is a cost-effective real-time modality, although image quality can vary greatly depending on the target anatomy. Cone-beam computed tomography (CBCT) scans are sometimes available, so 2D–3D registration is needed for intra-procedural guidance. C-arm radiographs were registered to CBCT scans and used for 3D localization of peritumor fiducials during a minimally invasive thoracic intervention with a da Vinci Si robot. Methods Intensity-based 2D–3D registration of intraoperative radiographs to CBCT was performed. The feasible range of X-ray projections achievable by a C-arm positioned around a da Vinci Si surgical robot, configured for robotic wedge resection, was determined using phantom models. Experiments were conducted on synthetic phantoms and animals imaged with an OEC 9600 and a Siemens Artis zeego, representing the spectrum of different C-arm systems currently available for clinical use. Results The image guidance workflow was feasible using either an optically tracked OEC 9600 or a Siemens Artis zeego C-arm, resulting in an angular difference of Δθ : ~ 30°. The two C-arm systems provided TREmean ≤ 2.5 mm and TREmean ≤ 2.0 mm, respectively (i.e., comparable to standard clinical intraoperative navigation systems). Conclusions C-arm 3D localization from dual 2D–3D registered radiographs was feasible and applicable for intraoperative image guidance during da Vinci robotic thoracic interventions using the proposed workflow. Tissue deformation and in vivo experiments are required before clinical evaluation of this system. PMID:25503592

Effect of visual distraction and auditory feedback on patient effort during robot-assisted movement training after stroke

PubMed Central

2011-01-01

Background Practicing arm and gait movements with robotic assistance after neurologic injury can help patients improve their movement ability, but patients sometimes reduce their effort during training in response to the assistance. Reduced effort has been hypothesized to diminish clinical outcomes of robotic training. To better understand patient slacking, we studied the role of visual distraction and auditory feedback in modulating patient effort during a common robot-assisted tracking task. Methods Fourteen participants with chronic left hemiparesis from stroke, five control participants with chronic right hemiparesis and fourteen non-impaired healthy control participants, tracked a visual target with their arms while receiving adaptive assistance from a robotic arm exoskeleton. We compared four practice conditions: the baseline tracking task alone; tracking while also performing a visual distracter task; tracking with the visual distracter and sound feedback; and tracking with sound feedback. For the distracter task, symbols were randomly displayed in the corners of the computer screen, and the participants were instructed to click a mouse button when a target symbol appeared. The sound feedback consisted of a repeating beep, with the frequency of repetition made to increase with increasing tracking error. Results Participants with stroke halved their effort and doubled their tracking error when performing the visual distracter task with their left hemiparetic arm. With sound feedback, however, these participants increased their effort and decreased their tracking error close to their baseline levels, while also performing the distracter task successfully. These effects were significantly smaller for the participants who used their non-paretic arm and for the participants without stroke. Conclusions Visual distraction decreased participants effort during a standard robot-assisted movement training task. This effect was greater for the hemiparetic arm, suggesting that the increased demands associated with controlling an affected arm make the motor system more prone to slack when distracted. Providing an alternate sensory channel for feedback, i.e., auditory feedback of tracking error, enabled the participants to simultaneously perform the tracking task and distracter task effectively. Thus, incorporating real-time auditory feedback of performance errors might improve clinical outcomes of robotic therapy systems. PMID:21513561

Intra-operative 3D guidance and edema detection in prostate brachytherapy using a non-isocentric C-arm

PubMed Central

Jain, A.; Deguet, A.; Iordachita, I.; Chintalapani, G.; Vikal, S.; Blevins, J.; Le, Y.; Armour, E.; Burdette, C.; Song, D.; Fichtinger, G.

2015-01-01

Purpose Brachytherapy (radioactive seed insertion) has emerged as one of the most effective treatment options for patients with prostate cancer, with the added benefit of a convenient outpatient procedure. The main limitation in contemporary brachytherapy is faulty seed placement, predominantly due to the presence of intra-operative edema (tissue expansion). Though currently not available, the capability to intra-operatively monitor the seed distribution, can make a significant improvement in cancer control. We present such a system here. Methods Intra-operative measurement of edema in prostate brachytherapy requires localization of inserted radioactive seeds relative to the prostate. Seeds were reconstructed using a typical non-isocentric C-arm, and exported to a commercial brachytherapy treatment planning system. Technical obstacles for 3D reconstruction on a non-isocentric C-arm include pose-dependent C-arm calibration; distortion correction; pose estimation of C-arm images; seed reconstruction; and C-arm to TRUS registration. Results In precision-machined hard phantoms with 40–100 seeds and soft tissue phantoms with 45–87 seeds, we correctly reconstructed the seed implant shape with an average 3D precision of 0.35 mm and 0.24 mm, respectively. In a DoD Phase-1 clinical trial on six patients with 48–82 planned seeds, we achieved intra-operative monitoring of seed distribution and dosimetry, correcting for dose inhomogeneities by inserting an average of over four additional seeds in the six enrolled patients (minimum 1; maximum 9). Additionally, in each patient, the system automatically detected intra-operative seed migration induced due to edema (mean 3.84 mm, STD 2.13 mm, Max 16.19 mm). Conclusions The proposed system is the first of a kind that makes intra-operative detection of edema (and subsequent re-optimization) possible on any typical non-isocentric C-arm, at negligible additional cost to the existing clinical installation. It achieves a significantly more homogeneous seed distribution, and has the potential to affect a paradigm shift in clinical practice. Large scale studies and commercialization are currently underway. PMID:21168357

Randomized Phase II Study of Clofarabine-Based Consolidation for Younger Adults With Acute Myeloid Leukemia in First Remission.

PubMed

Thomas, Xavier; de Botton, Stéphane; Chevret, Sylvie; Caillot, Denis; Raffoux, Emmanuel; Lemasle, Emilie; Marolleau, Jean-Pierre; Berthon, Céline; Pigneux, Arnaud; Vey, Norbert; Reman, Oumedaly; Simon, Marc; Recher, Christian; Cahn, Jean-Yves; Hermine, Olivier; Castaigne, Sylvie; Celli-Lebras, Karine; Ifrah, Norbert; Preudhomme, Claude; Terré, Christine; Dombret, Hervé

2017-04-10

Purpose To evaluate the efficacy and safety of a clofarabine-based combination (CLARA) versus conventional high-dose cytarabine (HDAC) as postremission chemotherapy in younger patients with acute myeloid leukemia (AML). Patients and Methods Patients age 18 to 59 years old with intermediate- or unfavorable-risk AML in first remission and no identified donor for allogeneic stem-cell transplantation (SCT) were eligible. Two hundred twenty-one patients were randomly assigned to receive three CLARA or three HDAC consolidation cycles. The primary end point was relapse-free survival (RFS). To handle the confounding effect of SCT that could occur in patients with late donor identification, hazard ratios (HRs) of events were adjusted on the time-dependent treatment × SCT interaction term. Results At 2 years, RFS was 58.5% (95% CI, 49% to 67%) in the CLARA arm and 46.5% (95% CI, 37% to 55%) in the HDAC arm. Overall, 110 patients (55 in each arm) received SCT in first remission. On the basis of a multivariable Cox-adjusted treatment × SCT interaction, the HR of CLARA over HDAC before or in absence of SCT was 0.65 (95% CI, 0.43 to 0.98; P = .041). In a sensitivity analysis, when patients who received SCT in first remission were censored at SCT time, 2-year RFS was 53.3% (95% CI, 39% to 66%) in the CLARA arm and 31.0% (95% CI, 19% to 43%) in the HDAC arm (HR, 0.63; 95% CI, 0.41 to 0.98; P = .043). Gain in RFS could be related to the lower cumulative incidence of relapse observed in the CLARA arm versus the HDAC arm (33.9% v 46.4% at 2 years, respectively; cause-specific HR, 0.61; 95% CI, 0.40 to 0.94; P = .025). CLARA cycles were associated with higher hematologic and nonhematologic toxicity than HDAC cycles. Conclusion These results suggest that CLARA might be considered as a new chemotherapy option in younger patients with AML in first remission.

Randomized study of intensified anthracycline doses for induction and recombinant interleukin-2 for maintenance in patients with acute myeloid leukemia age 50 to 70 years: results of the ALFA-9801 study.

PubMed

Pautas, Cecile; Merabet, Fatiha; Thomas, Xavier; Raffoux, Emmanuel; Gardin, Claude; Corm, Selim; Bourhis, Jean-Henri; Reman, Oumedaly; Turlure, Pascal; Contentin, Nathalie; de Revel, Thierry; Rousselot, Philippe; Preudhomme, Claude; Bordessoule, Dominique; Fenaux, Pierre; Terré, Christine; Michallet, Mauricette; Dombret, Hervé; Chevret, Sylvie; Castaigne, Sylvie

2010-02-10

PURPOSE In patients with acute myeloid leukemia (AML), induction chemotherapy is based on standard doses of anthracyclines and cytarabine. High doses of cytarabine have been reported as being too toxic for patients older than age 50 years, but few studies have evaluated intensified doses of anthracyclines. PATIENTS AND METHODS In this randomized Acute Leukemia French Association 9801 (ALFA-9801) study, high doses of daunorubicin (DNR; 80 mg/m(2)/d x 3 days) or idarubicin (IDA4; 12 mg/m(2)/d x 4 days) were compared with standard doses of idarubicin (IDA3; 12 mg/m(2)/d x 3 days) for remission induction in patients age 50 to 70 years, with an event-free survival (EFS) end point. After two consolidation courses based on intermediate doses of cytarabine, patients in continuous remission were randomly assigned to receive or not receive maintenance therapy with recombinant interleukin-2 (rIL-2; 5 x 10(6) U/m(2) x 5 days each month) for a total duration of 12 months. A total of 468 patients entered the study (median age, 60 years). Results Overall complete remission rate was 77% with significant differences among the three randomization arms (83%, 78%, and 70% in the IDA3, IDA4, and DNR arms, respectively; P = .04). However, no significant differences were observed in relapse incidence, EFS, or overall survival among the three arms. In the 161 patients randomly assigned for maintenance therapy, no difference in outcome was observed between the rIL-2 and the no further treatment arms. CONCLUSION Neither intensification of anthracycline doses nor maintenance with rIL-2 showed a significant impact on AML course, at least as scheduled in this trial.

Comparison of patient comprehension of rapid HIV pre-test fundamentals by information delivery format in an emergency department setting

PubMed Central

Merchant, Roland C; Gee, Erin M; Clark, Melissa A; Mayer, Kenneth H; Seage, George R; DeGruttola, Victor G

2007-01-01

Background Two trials were conducted to compare emergency department patient comprehension of rapid HIV pre-test information using different methods to deliver this information. Methods Patients were enrolled for these two trials at a US emergency department between February 2005 and January 2006. In Trial One, patients were randomized to a no pre-test information or an in-person discussion arm. In Trial Two, a separate group of patients were randomized to an in-person discussion arm or a Tablet PC-based video arm. The video, "Do you know about rapid HIV testing?", and the in-person discussion contained identical Centers for Disease Control and Prevention-suggested pre-test information components as well as information on rapid HIV testing with OraQuick®. Participants were compared by information arm on their comprehension of the pre-test information by their score on a 26-item questionnaire using the Wilcoxon rank-sum test. Results In Trial One, 38 patients completed the no-information arm and 31 completed the in-person discussion arm. Of these 69 patients, 63.8% had twelve years or fewer of formal education and 66.7% had previously been tested for HIV. The mean score on the questionnaire for the in-person discussion arm was higher than for the no information arm (18.7 vs. 13.3, p ≤ 0.0001). In Trial Two, 59 patients completed the in-person discussion and 55 completed the video arms. Of these 114 patients, 50.9% had twelve years or fewer of formal education and 68.4% had previously been tested for HIV. The mean score on the questionnaire for the video arm was similar to the in-person discussion arm (20.0 vs. 19.2; p ≤ 0.33). Conclusion The video "Do you know about rapid HIV testing?" appears to be an acceptable substitute for an in-person pre-test discussion on rapid HIV testing with OraQuick®. In terms of adequately informing ED patients about rapid HIV testing, either form of pre-test information is preferable than for patients to receive no pre-test information. PMID:17850670

Spiral arms and disc stability in the Andromeda galaxy

NASA Astrophysics Data System (ADS)

Tenjes, P.; Tuvikene, T.; Tamm, A.; Kipper, R.; Tempel, E.

2017-04-01

Aims: Density waves are often considered as the triggering mechanism of star formation in spiral galaxies. Our aim is to study relations between different star formation tracers (stellar UV and near-IR radiation and emission from H I, CO, and cold dust) in the spiral arms of M 31, to calculate stability conditions in the galaxy disc, and to draw conclusions about possible star formation triggering mechanisms. Methods: We selected fourteen spiral arm segments from the de-projected data maps and compared emission distributions along the cross sections of the segments in different datasets to each other, in order to detect spatial offsets between young stellar populations and the star-forming medium. By using the disc stability condition as a function of perturbation wavelength and distance from the galaxy centre, we calculated the effective disc stability parameters and the least stable wavelengths at different distances. For this we used a mass distribution model of M 31 with four disc components (old and young stellar discs, cold and warm gaseous discs) embedded within the external potential of the bulge, the stellar halo, and the dark matter halo. Each component is considered to have a realistic finite thickness. Results: No systematic offsets between the observed UV and CO/far-IR emission across the spiral segments are detected. The calculated effective stability parameter has a lowest value of Qeff ≃ 1.8 at galactocentric distances of 12-13 kpc. The least stable wavelengths are rather long, with the lowest values starting from ≃ 3 kpc at distances R > 11 kpc. Conclusions: The classical density wave theory is not a realistic explanation for the spiral structure of M 31. Instead, external causes should be considered, such as interactions with massive gas clouds or dwarf companions of M 31.

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

Myers, R.K.

This paper examines the political and technical verification issues associated with proposals to place quantitative and/or qualitative limits on the deployment of nuclear-armed sea-launched cruise missiles (SLCMs). Overviews of the arms control relationship between the United States and the Soviet Union, the development of the SLCM, and Soviet and American concepts of verification are presented. The views of the American arms control and defense communities regarding the SLCM is discussed in depth, accompanied by a detailed examination of the various methods which have been proposed to verify a SLCM limitation agreement. The conclusion is that there are no technological barriers,more » per se, to SLCM verification, but as the decision on an agreement's verifiability is a political one, the U.S. Navy should concentrate its arguments against SLCM limitations on the weapon's operational utility rather than argue that such an agreement is unverifiable.« less

The therapeutic effect of balneotherapy: evaluation of the evidence from randomised controlled trials.

PubMed

Falagas, M E; Zarkadoulia, E; Rafailidis, P I

2009-07-01

Systematic review. There is widespread popular belief that balneotherapy is effective in the treatment of various ailments. We searched PubMed (1950-2006), Scopus and Cochrane library for randomised controlled trials (RCTs), examining the clinical effect of balneotherapy (both as a solitary approach and in the context of spa) on various diseases. A total of 203 potentially relevant articles were identified. In all, 29 RCTs were further evaluated; 22 of them (75.8%) investigated the use of balneotherapy in rheumatological diseases and eight osteoarthritis, six fibromyalgia, four ankylosing spondylitis, four rheumatoid arthritis and three RCTs (10.3%) in other musculoskeletal system diseases (chronic low back pain). In addition, three relevant studies focused on psoriasis and one on Parkinson's disease. A total of 1720 patients with rheumatological and other musculoskeletal diseases were evaluated in these studies. Balneotherapy did result in more pain improvement (statistically different) in patients with rheumatological diseases and chronic low back pain in comparison to the control group in 17 (68%) of the 25 RCTs examined. In the remaining eight studies, pain was improved in the balneotherapy treatment arm, but this improvement was statistically not different than that of the comparator treatment arm(s). This beneficial effect lasted for different periods of time: 10 days in one study, 2 weeks in one study, 3 weeks in one study, 12 weeks in 2 studies, 3 months in 11 studies, 16-20 weeks in one study, 24 weeks in three studies, 6 months in three studies, 40 weeks in one study and 1 year in one study. The available data suggest that balneotherapy may be truly associated with improvement in several rheumatological diseases. However, existing research is not sufficiently strong to draw firm conclusions.

Assessing the benefits of five years of different approaches to treatment of urogenital schistosomiasis: A SCORE project in Northern Mozambique

PubMed Central

Gazzinelli-Guimaraes, Pedro H.; Aurelio, Herminio O.; Ferro, Josefo; Nala, Rassul; Clements, Michelle; King, Charles H.; Fenwick, Alan; Fleming, Fiona M.; Dhanani, Neerav

2017-01-01

Background In Mozambique, schistosomiasis is highly endemic across the whole country. The Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) coordinates a five-year study that has been implemented in various African countries, including Mozambique. The overall goal of SCORE was to better understand how to best apply preventive chemotherapy with praziquantel (PZQ) for schistosomiasis control by evaluating the impact of alternative treatment approaches. Methods This was a cluster-randomised trial that compared the impact of different treatment strategies in study areas with prevalence among school children of ≥21% S. haematobium infection by urine dipstick. Each village was randomly allocated to one of six possible combinations of community-wide treatment (CWT), school-based treatment (SBT), and/or drug holidays over a period of four years, followed by final data collection in the fifth year. The most intense intervention arm involved four years of CWT, while the least intensive arm involved two years of SBT followed by two consecutive years of PZQ holiday. Each study arm included 25 villages randomly assigned to one of the six treatment arms. The primary outcome of interest was change in prevalence and intensity of S. haematobium among 100 children aged 9-to-12-years that were sampled each year in every village. In addition to children aged 9-to-12 years, 100 children aged 5–8 years in their first-year of school and 50 adults (aged 20–55 years) were tested in the first and final fifth year of the study. Prevalence and intensity of S. haematobium infection was evaluated by two filtrations, each of 10mL, from a single urine specimen. Principal findings In total, data was collected from 81,167 individuals across 149 villages in ten districts of Cabo Delgado province, Northern Mozambique. Overall PZQ treatment resulted in a significant reduction in the prevalence of S. haematobium infection from Year 1 to Year 5, where the average prevalence went from 60.5% to 38.8%, across all age groups and treatment arms. The proportion of those heavily infected also reduced from 17.6% to 11.9% over five years. There was a significantly higher likelihood of males being infected than females at baseline, but no significant difference between the sexes in their response to treatment. The only significant response based on a study arm was seen in both the 9-to-12-year-old and first-year cross sections, where two consecutive treatment holidays resulted in a significantly higher final prevalence of S. haematobium than no treatment holidays. When the arms were grouped together, four rounds of treatment (regardless of whether it was CWT or SBT), however, did result in a significantly greater reduction in S. haematobium prevalence than two rounds of treatment (i.e. with two intermittent or consecutive holiday years) over a five-year period. Conclusions Although PC was successful in reducing the burden of active infection, even among those heavily infected, annual CWT did not have a significantly greater impact on disease prevalence or intensity than less intense treatment arms. This may be due to extremely high starting prevalence and intensity in the study area, with frequent exposure to reinfection, or related to challenges in achieving high treatment coverage More frequent treatment had a greater impact on prevalence and intensity of infection when arms were grouped by number of treatments, however, cost efficiency was greater in arms only receiving two treatments. Finally, a significant reduction in prevalence of S. haematobium was seen in adults even in the SBT arms implying the rate of transmission in the community had been decreased, even where only school children have been treated, which has significant logistical and cost-saving implications for a national control programme in justifying CWT. PMID:29220347

Primary tumor sites in relation to ultraviolet radiation exposure and skin visibility correlate with survival in cutaneous melanoma.

PubMed

Gordon, Daniela; Hansson, Johan; Eloranta, Sandra; Gordon, Max; Gillgren, Peter; Smedby, Karin E

2017-10-01

The prognostic value of detailed anatomic site and ultraviolet radiation (UVR) exposure patterns has not been fully determined in cutaneous melanoma. Thus, we reviewed medical records for detailed site in a population-based retrospective Swedish patient cohort diagnosed with primary invasive melanoma 1976-2003 (n = 5,973). We followed the patients from date of diagnosis until death, emigration or December 31 st 2013, and evaluated melanoma-specific survival by subsite in a multivariable regression model adjusting for established prognostic factors. We found that melanoma on chronic UVR exposure sites (face, dorsum of hands; adjusted HR 0.6; CI 0.4-0.7) and moderately intermittent UVR sites (lateral arms, lower legs, dorsum of feet; HR 0.7; CI 0.6-0.8) were associated with a favorable prognosis compared with highly intermittent sites (chest, back, neck, shoulders and thighs). Further, melanoma on poorly visible skin sites upon self-examination (scalp, retroauricular area, back, posterior upper arms and thighs, buttocks, pubic area; HR 1.3; CI 1.1-1.5) had a worse prognosis than those on easily visible sites (face, chest, abdomen, anterior upper arms and thighs, lower arms and legs, dorsum of hands and feet, palms). In conclusion, highly intermittent UVR exposure sites and poor skin visibility presumably correlate with reduced melanoma survival, independent of established tumor characteristics. A limitation of the study was the lack of information on actual individual UVR exposure. © 2017 UICC.

Skin Response to Delayed Hypersensitivity Testing in Persons With Unilateral Stroke-related Paresis: Implications for People With Spinal Cord Injury

PubMed Central

Trautner, Barbara W; Zimmermann, Kuno P; Squyres, Sara A; Darouiche, Rabih O

2007-01-01

Background: Vaccination rates among individuals with spinal cord injury (SCI) could be improved if it can be shown that vaccination performed on insensate areas is effective. This would eliminate the the risk of discomfort and soreness at the injection site. Objective: To determine whether immune responsiveness varies between areas with intact and impaired innervation in patients with stroke-related paresis. Design: Prospective trial in which each subject served as his or her own control. Setting: Rehabilitation wards and long-term care units at a Veterans Affairs Medical Center. Patients: Individuals with a history of cerebrovascular accident (CVA) affecting 1 side of the body. Methods: The Multitest cell-mediated immunity (CMI) and purified protein derivative (PPD) of tuberculin were administered intradermally to each arm of each subject. Main Outcome Measures: Total millimeters of induration in response to either test and positive vs negative responses to either test were compared between the 2 arms of each subject. Results: Response to delayed hypersensitivity testing did not differ between the arms affected and unaffected by CVA in each subject, and the time since CVA also did not affect the magnitude of the skin response. Conclusions: Skin testing for delayed hypersensitivity can be effectively administered in the paretic arms of persons who have experienced CVA. Although this study was performed in patients with stroke-related impairment, it has implications for vaccine administration in individuals with SCI-related neurologic deficits. PMID:17853658

Anthropometric evaluation of pediatric patients with nonprogressive chronic encephalopathy according to different methods of classification☆

PubMed Central

Teixeira, Jéssica Socas; Gomes, Mirian Martins

2014-01-01

Objective: To perform anthropometric assessment of patients with quadriplegic, chronic non-progressive encephalopathy, comparing two distinct references of nutritional classification and to compare the estimated height to the length measured by stadiometer. Method: Cross-sectional study including 0-3-year children with quadriplegic chronic non-progressive encephalopathy in secondary public hospital. Length, weight, arm circumference, triceps skinfold and knee height were measured. The arm muscle circumference and estimated height were calculated. The following relations were evaluated: weight-for-age, length-for-age and weight-for-length, using as reference the charts of the World Health Organization (WHO) and those proposed by Krick et al. Results: Fourteen children with a mean age of 21 months were evaluated. Assessment of anthropometric indicators showed significant difference between the two classification methods to assess nutritional indicators length/age (p=0.014), weight/age (p=0.014) and weight/length (p=0.001). There was significant correlation between measured length and estimated height (r=0.796, p=0.001). Evaluation of arm circumference and triceps skinfold showed that most patients presented some degree of malnutrition. According to arm muscle circumference, most were eutrophic. Conclusions: Specific curves for children with chronic non-progressive encephalopathy appear to underestimate malnutrition when one takes into account indicators involving weight. Curves developed for healthy children can be a good option for clinical practice and weight-for-length indicator and body composition measurements should be considered as complementary tools. PMID:25479849

Impact of including or excluding both-armed zero-event studies on using standard meta-analysis methods for rare event outcome: a simulation study

PubMed Central

Cheng, Ji; Pullenayegum, Eleanor; Marshall, John K; Thabane, Lehana

2016-01-01

Objectives There is no consensus on whether studies with no observed events in the treatment and control arms, the so-called both-armed zero-event studies, should be included in a meta-analysis of randomised controlled trials (RCTs). Current analytic approaches handled them differently depending on the choice of effect measures and authors' discretion. Our objective is to evaluate the impact of including or excluding both-armed zero-event (BA0E) studies in meta-analysis of RCTs with rare outcome events through a simulation study. Method We simulated 2500 data sets for different scenarios varying the parameters of baseline event rate, treatment effect and number of patients in each trial, and between-study variance. We evaluated the performance of commonly used pooling methods in classical meta-analysis—namely, Peto, Mantel-Haenszel with fixed-effects and random-effects models, and inverse variance method with fixed-effects and random-effects models—using bias, root mean square error, length of 95% CI and coverage. Results The overall performance of the approaches of including or excluding BA0E studies in meta-analysis varied according to the magnitude of true treatment effect. Including BA0E studies introduced very little bias, decreased mean square error, narrowed the 95% CI and increased the coverage when no true treatment effect existed. However, when a true treatment effect existed, the estimates from the approach of excluding BA0E studies led to smaller bias than including them. Among all evaluated methods, the Peto method excluding BA0E studies gave the least biased results when a true treatment effect existed. Conclusions We recommend including BA0E studies when treatment effects are unlikely, but excluding them when there is a decisive treatment effect. Providing results of including and excluding BA0E studies to assess the robustness of the pooled estimated effect is a sensible way to communicate the results of a meta-analysis when the treatment effects are unclear. PMID:27531725

Dosing Strategies for Lithium Monotherapy in Children and Adolescents with Bipolar I Disorder

PubMed Central

Kafantaris, Vivian; Pavuluri, Mani; McNamara, Nora K.; McClellan, Jon; Frazier, Jean A.; Sikich, Linmarie; Kowatch, Robert; Lingler, Jacqui; Faber, Jon; Rowles, Brieana M.; Clemons, Traci E.; Taylor-Zapata, Perdita

2011-01-01

Abstract Objective The primary goal of this exploratory study was to obtain data that could lead to evidence-based dosing strategies for lithium in children and adolescents suffering from bipolar I disorder. Methods Outpatients aged 7–17 years meeting Diagnostic and Statistical Manual of Mental Disorders, 4th edition, diagnostic criteria for bipolar I disorder (manic or mixed) were eligible for 8 weeks of open label treatment with lithium in one of three dosing arms. In Arm I, participants began treatment at a dose of 300 mg of lithium twice daily. The starting dose of lithium in Arms II and III was 300 mg thrice daily. Patients in Arms I and II could have their dose increased by 300 mg/day, depending on clinical response, at weekly visits. Patients in Arm III also had mid-week telephone interviews after which they could also have their dose of lithium increased by 300 mg per day. Youths weighing <30 kg were automatically assigned to Arm I, whereas youths weighing ≥30 kg were randomly assigned to Arm I, II, or III. Randomization was balanced by age (7–11 years, 12–17 years) and sex in approximately equal numbers. A priori response criteria were defined as a Clinical Global Impressions-Improvement scale score of ≤2 and a 50% decrease from baseline on the Young Mania Rating Scale. Results Of the 61 youths [32 males (52.5%)] who received open-label lithium, 60 youths completed at least 1 week of treatment and returned for a postbaseline assessment. Most patients had a ≥50% improvement in Young Mania Rating Scale score, and more than half of the patients (58%) achieved response. Overall, lithium was well tolerated. All three treatment arms had similar effectiveness, side effect profiles, and tolerability of lithium. Conclusions On the basis of these results, a dosing strategy in which pediatric patients begin lithium at a dose of 300 mg thrice daily (with an additional 300 mg increase during the first week), followed by 300 mg weekly increases until a priori stopping criteria are met, will be used in an upcoming randomized, placebo-controlled trial. PMID:21663422

Exercise Preserves Lean Mass and Performance during Severe Energy Deficit: The Role of Exercise Volume and Dietary Protein Content.

PubMed

Calbet, Jose A L; Ponce-González, Jesús G; Calle-Herrero, Jaime de La; Perez-Suarez, Ismael; Martin-Rincon, Marcos; Santana, Alfredo; Morales-Alamo, David; Holmberg, Hans-Christer

2017-01-01

The loss of fat-free mass (FFM) caused by very-low-calorie diets (VLCD) can be attenuated by exercise. The aim of this study was to determine the role played by exercise and dietary protein content in preserving the lean mass and performance of exercised and non-exercised muscles, during a short period of extreme energy deficit (~23 MJ deficit/day). Fifteen overweight men underwent three consecutive experimental phases: baseline assessment (PRE), followed by 4 days of caloric restriction and exercise (CRE) and then 3 days on a control diet combined with reduced exercise (CD). During CRE, the participants ingested a VLCD and performed 45 min of one-arm cranking followed by 8 h walking each day. The VLCD consisted of 0.8 g/kg body weight/day of either whey protein (PRO, n = 8) or sucrose (SU, n = 7). FFM was reduced after CRE ( P < 0.001), with the legs and the exercised arm losing proportionally less FFM than the control arm [57% ( P < 0.05) and 29% ( P = 0.05), respectively]. Performance during leg pedaling, as reflected by the peak oxygen uptake and power output (Wpeak), was reduced after CRE by 15 and 12%, respectively ( P < 0.05), and recovered only partially after CD. The deterioration of cycling performance was more pronounced in the whey protein than sucrose group ( P < 0.05). Wpeak during arm cranking was unchanged in the control arm, but improved in the contralateral arm by arm cranking. There was a linear relationship between the reduction in whole-body FFM between PRE and CRE and the changes in the cortisol/free testosterone ratio (C/FT), serum isoleucine, leucine, tryptophan, valine, BCAA, and EAA ( r = -0.54 to -0.71, respectively, P < 0.05). C/FT tended to be higher in the PRO than the SU group following CRE ( P = 0.06). In conclusion, concomitant low-intensity exercise such as walking or arm cranking even during an extreme energy deficit results in remarkable preservation of lean mass. The intake of proteins alone may be associated with greater cortisol/free testosterone ratio and is not better than the ingestion of only carbohydrates for preserving FFM and muscle performance in interventions of short duration.

Exercise Preserves Lean Mass and Performance during Severe Energy Deficit: The Role of Exercise Volume and Dietary Protein Content

PubMed Central

Calbet, Jose A. L.; Ponce-González, Jesús G.; Calle-Herrero, Jaime de La; Perez-Suarez, Ismael; Martin-Rincon, Marcos; Santana, Alfredo; Morales-Alamo, David; Holmberg, Hans-Christer

2017-01-01

The loss of fat-free mass (FFM) caused by very-low-calorie diets (VLCD) can be attenuated by exercise. The aim of this study was to determine the role played by exercise and dietary protein content in preserving the lean mass and performance of exercised and non-exercised muscles, during a short period of extreme energy deficit (~23 MJ deficit/day). Fifteen overweight men underwent three consecutive experimental phases: baseline assessment (PRE), followed by 4 days of caloric restriction and exercise (CRE) and then 3 days on a control diet combined with reduced exercise (CD). During CRE, the participants ingested a VLCD and performed 45 min of one-arm cranking followed by 8 h walking each day. The VLCD consisted of 0.8 g/kg body weight/day of either whey protein (PRO, n = 8) or sucrose (SU, n = 7). FFM was reduced after CRE (P < 0.001), with the legs and the exercised arm losing proportionally less FFM than the control arm [57% (P < 0.05) and 29% (P = 0.05), respectively]. Performance during leg pedaling, as reflected by the peak oxygen uptake and power output (Wpeak), was reduced after CRE by 15 and 12%, respectively (P < 0.05), and recovered only partially after CD. The deterioration of cycling performance was more pronounced in the whey protein than sucrose group (P < 0.05). Wpeak during arm cranking was unchanged in the control arm, but improved in the contralateral arm by arm cranking. There was a linear relationship between the reduction in whole-body FFM between PRE and CRE and the changes in the cortisol/free testosterone ratio (C/FT), serum isoleucine, leucine, tryptophan, valine, BCAA, and EAA (r = −0.54 to −0.71, respectively, P < 0.05). C/FT tended to be higher in the PRO than the SU group following CRE (P = 0.06). In conclusion, concomitant low-intensity exercise such as walking or arm cranking even during an extreme energy deficit results in remarkable preservation of lean mass. The intake of proteins alone may be associated with greater cortisol/free testosterone ratio and is not better than the ingestion of only carbohydrates for preserving FFM and muscle performance in interventions of short duration. PMID:28790922

Three-Dimensional Scapular Kinematics in Patients with Reverse Total Shoulder Arthroplasty during Arm Motion

PubMed Central

Lee, Kwang Won; Kim, Ha Yong; Yang, Dae Suk; Lee, Gyu Sang; Choy, Won Sik

2016-01-01

Background There have been few reports on altered kinematics of the shoulder after reverse total shoulder arthroplasty (RTSA). We investigated differences in 3-dimensional (3D) scapular motions assessed using an optical tracking system between RTSA treated shoulders and asymptomatic contralateral shoulders during arm motion. Methods Thirteen patients who underwent RTSA were assessed for active arm elevation in 2 distinct elevation planes (sagittal plane flexion and scapular plane abduction). Their mean age was 72 years (range, 69 to 79 years) and the mean follow-up was 24.4 months (range, 13 to 48 months). The dominant side was the right side in all the 13 patients, and it was also the side treated with RTSA. Scapular kinematics was recorded with an optical tracking system. The scapular kinematics and the scapulohumeral rhythm (SHR) of the RTSA shoulders and asymptomatic contralateral shoulders were recorded and analyzed during arm elevation. Results There were no significant differences in internal/external rotation and anterior/posterior tilting of the scapula between shoulders during arm motion (p > 0.05). However, upward rotation of the scapula differed significantly during arm motion (p = 0.035 for sagittal plane flexion; p = 0.046 for scapular plane abduction). There were significant differences in the SHR between the two shoulders (p = 0.016 for sagittal plane flexion; p = 0.021 for scapular plane abduction). Conclusions The shoulder kinematics after RTSA showed significant differences from the contralateral asymptomatic shoulders. Increased upward rotation and decreased SHR after RTSA indicate that RTSA shoulders use more scapulothoracic motion and less glenohumeral motion to elevate the arm. PMID:27583116

Sustaining Mammography Screening Among the Medically Underserved: A Follow-Up Evaluation

PubMed Central

Arnold, Connie L.; Bennett, Charles L.; Wolf, Michael S.; Liu, Dachao; Rademaker, Alfred

2015-01-01

Abstract Background: Our previous three-arm comparative effectiveness intervention in community clinic patients who were not up-to-date with screening resulted in mammography rates over 50% in all arms. Objective: Our aim was to evaluate the effectiveness and cost-effectiveness of the three interventions on improving biennial screening rates among eligible patients. Methods: A three-arm quasi-experimental evaluation was conducted in eight community clinics from 2008 to 2011. Screening efforts included (1) enhanced care: Participants received an in-person recommendation from a research assistant (RA) in year 1, and clinics followed usual clinic protocol for scheduling screening mammograms; (2) education intervention: Participants received education and in-person recommendation from an RA in year 1, and clinics followed usual clinic protocol for scheduling mammograms; or (3) nurse support: A nurse manager provided in-person education and recommendation, scheduled mammograms, and followed up with phone support. In all arms, mammography was offered at no cost to uninsured patients. Results: Of 624 eligible women, biennial mammography within 24–30 months of their previous test was performed for 11.0% of women in the enhanced-care arm, 7.1% in the education- intervention arm, and 48.0% in the nurse-support arm (p<0.0001). The incremental cost was $1,232 per additional woman undergoing screening with nurse support vs. enhanced care and $1,092 with nurse support vs. education. Conclusions: Biennial mammography screening rates were improved by providing nurse support but not with enhanced care or education. However, this approach was not cost-effective. PMID:25692910

Contralesional arm preference depends on hemisphere of damage and target location in unilateral stroke patients

PubMed Central

Mani, Saandeep; Przybyla, Andrzej; Good, David C.; Haaland, Kathleen Y.; Sainburg, Robert L.

2014-01-01

Background Previous research has shown that during simulated activities of daily living right handed stroke patients use their contralesional arm more after left than right hemisphere stroke. These findings were attributed to a hand preference effect. However, these decisions about when to use the contralesional arm may be modulated by where in the work space the task is performed, a factor that could be used in physical rehabilitation to influence recovery by decreasing learned non-use. Objective To examine how target location and side of stroke influences arm selection choices for simple reaching movements. Methods Fourteen right-handed stroke patients (7 with left hemisphere damage, 7 with right hemisphere damage) with similar degree of hemiparesis (Fugl-Meyer motor score), and 16 right-handed control subjects participated in this experiment. Thirty-two targets were presented throughout the reachable horizontal plane workspace in a pseudo-random fashion, and the subjects were asked to select one hand to reach the target on each trial. Results The left hemisphere damaged group chose their contralesional arm significantly more often than the right hemisphere damaged group. Patients with right hemisphere damage also chose their left (contralesional) arm significantly less than the control group. However, these patterns of choice were most pronounced in the center of the workspace. Conclusion Both the side of hemisphere damage and workspace location played a significant role in the choice of whether to use the contralesional arm for reaching. These findings have implications for structuring rehabilitation for unilateral stroke patients. PMID:24523143

Preoperative mental health status may not be predictive of improvements in patient-reported outcomes following an anterior cervical discectomy and fusion.

PubMed

Mayo, Benjamin C; Massel, Dustin H; Bohl, Daniel D; Narain, Ankur S; Hijji, Fady Y; Long, William W; Modi, Krishna D; Basques, Bryce A; Yacob, Alem; Singh, Kern

2017-02-01

OBJECTIVE Prior studies have correlated preoperative depression and poor mental health status with inferior patient-reported outcomes following lumbar spinal procedures. However, literature regarding the effect of mental health on outcomes following cervical spinal surgery is limited. As such, the purpose of this study is to test for the association of preoperative SF-12 Mental Component Summary (MCS) scores with improvements in Neck Disability Index (NDI), SF-12 Physical Component Summary (PCS), and neck and arm pain following anterior cervical discectomy and fusion (ACDF). METHODS A prospectively maintained surgical database of patients who underwent a primary 1- or 2-level ACDF during 2014-2015 was reviewed. Patients were excluded if they did not have complete patient-reported outcome data for the preoperative or 6-week, 12-week, or 6-month postoperative visits. At baseline, preoperative SF-12 MCS score was assessed for association with preoperative NDI, neck visual analog scale (VAS) score, arm VAS score, and SF-12 PCS score. The preoperative MCS score was then tested for association with changes in NDI, neck VAS, arm VAS, and SF-12 PCS scores from the preoperative visit to postoperative visits. These tests were conducted using multivariate regression controlling for baseline characteristics as well as for the preoperative score for the patient-reported outcome being assessed. RESULTS A total of 52 patients were included in the analysis. At baseline, a higher preoperative MCS score was negatively associated with a lower preoperative NDI (coefficient: -0.74, p < 0.001) and preoperative arm VAS score (-0.06, p = 0.026), but not preoperative neck VAS score (-0.03, p = 0.325) or SF-12 PCS score (0.04, p = 0.664). Additionally, there was no association between preoperative MCS score and improvement in NDI, neck VAS, arm VAS, or SF-12 PCS score at any of the postoperative time points (6 weeks, 12 weeks, and 6 months, p > 0.05 for each). The percentage of patients achieving a minimum clinically important difference at 6 months did not differ between the bottom and top MCS score halves (p > 0.05 for each). CONCLUSIONS The results of this study suggest that better preoperative mental health status is associated with lower perceived preoperative disability but is not associated with severity of preoperative neck or arm pain. In contrast to other studies, the present study was unable to demonstrate that preoperative mental health is predictive of improvement in patient-reported outcomes at any postoperative time point following an ACDF.

Research Review: Psychosocial adjustment and mental health in former child soldiers – a systematic review of the literature and recommendations for future research

PubMed Central

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

2014-01-01

Aims and scope This article reviews the available quantitative research on psychosocial adjustment and mental health among children (age <18 years) associated with armed forces and armed groups (CAAFAG) – commonly referred to as child soldiers. Methods PRISMA standards for systematic reviews were used to search PubMed, PsycInfo, JSTOR, and Sociological Abstracts in February 2012 for all articles on former child soldiers and CAAFAG. Twenty-one quantitative studies from 10 countries were analyzed for author, year of publication, journal, objectives, design, selection population, setting, instruments, prevalence estimates, and associations with war experiences. Opinion pieces, editorials, and qualitative studies were deemed beyond the scope of this study. Quality of evidence was rated according to the Systematic Assessment of Quality in Observational Research (SAQOR). Findings According to SAQOR criteria, among the available published studies, eight studies were of high quality, four were of moderate quality, and the remaining nine were of low quality. Common limitations were lack of validated mental health measures, unclear methodology including undefined sampling approaches, and failure to report missing data. Only five studies included a comparison group of youth not involved with armed forces/armed groups, and only five studies assessed mental health at more than one point in time. Across studies, a number of risk and protective factors were associated with postconflict psychosocial adjustment and social reintegration in CAAFAG. Abduction, age of conscription, exposure to violence, gender, and community stigma were associated with increased internalizing and externalizing mental health problems. Family acceptance, social support, and educational/economic opportunities were associated with improved psychosocial adjustment. Conclusions Research on the social reintegration and psychosocial adjustment of former child soldiers is nascent. A number of gaps in the available literature warrant future study. Recommendations to bolster the evidence base on psychosocial adjustment in former child soldiers and other war-affected youth include more studies comprising longitudinal study designs, and validated cross-cultural instruments for assessing mental health, as well as more integrated community-based approaches to study design and research monitoring. PMID:23061830

Pituitary gland volume in at-risk mental state for psychosis: a longitudinal MRI analysis.

PubMed

Walter, Anna; Studerus, Erich; Smieskova, Renata; Tamagni, Corinne; Rapp, Charlotte; Borgwardt, Stefan J; Riecher-Rössler, Anita

2015-04-01

Pituitary enlargement has been reported in individuals with schizophrenic psychosis or an at-risk mental state for psychosis (ARMS). In a previous study, our group could show pituitary volume increase in first episode and ARMS patients with later transition to psychosis (ARMS-T). However, there are no longitudinal studies on this issue so far. We therefore examined longitudinally whether transition to psychosis would be accompanied by a further increase of pituitary volume in antipsychotic-naïve ARMS patients. Magnetic resonance imaging (MRI) data were acquired from 23 antipsychotic-naïve individuals with an ARMS. Ten subjects developed psychosis (ARMS-T) and 13 did not (ARMS-NT). ARMS-T were re-scanned after the onset of psychosis, and ARMS-NT were re-scanned at the end of the study period. There was no significant difference of the pituitary volume between ARMS-T and ARMS-NT in our sample, and there were no significant pituitary volume changes over time. Discussion Longitudinally, we could not detect any further volumetric changes in the pituitary volume with transition to psychosis. This, together with the result of our previous study, could indicate that the perceived level of stress in ARMS patients is constantly high from very early onward.

The effect of thalidomide on the pharmacokinetics of irinotecan and metabolites in advanced solid tumor patients

PubMed Central

Ramírez, Jacqueline; Wu, Kehua; Janisch, Linda; Karrison, Theodore; House, Larry K.; Innocenti, Federico; Cohen, Ezra E. W.; Ratain, Mark J.

2011-01-01

Purpose Irinotecan and thalidomide are commonly administered antineoplastic drugs. Combination treatment may potentiate their antitumor effect and protect against irinotecan's intestinal toxicity. We investigated whether thalidomide can modulate the pharmacokinetics of irinotecan and metabolites. Methods The study employed a crossover design in which advanced solid tumor patients were randomized to two arms and treated with irinotecan 350 mg/m2 intravenously (IV) every 3 weeks and thalidomide orally (p.o.) 400 mg daily. Pharmacokinetic data when irinotecan was administered as a single agent in each arm were compared to data when the two study agents were co-administered using paired t tests. Eighty percent and 90% confidence intervals for the true difference were also calculated. Results The differences in pharmacokinetic parameters and metabolic markers after thalidomide administration were small and unlikely to be clinically significant. With the exception of APC T1/2, none of the upper confidence limits exceeds a 50% increase. Conclusions This study did not find any clinically meaningful effects of thalidomide on the pharmacokinetics of irinotecan or its metabolites. PMID:21861128

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

Sherrett, R.R.

This study investigates the relationship between NATO's decision to approach the problem created by the intermediate-range nuclear force superiority of the Soviets and the eventual signing of the INF Treaty by the United States and the Soviet Union. The concept presented is that by adopting the dual track decision, (a track for negotiations and a simultaneous track for fielding U.S. INF missiles), the United States was eventually able to conduct arms negotiations from a position of strength. In this way a significant contribution to the INF Treaty negotiation process was made. The study examines the position of each principal priormore » to the dual track decision, examines the role each played in that decision, and looks at the actions taken following the implementation of the dual track decision. The study also presents the nuclear background of NATO, and also examines the INF negotiations in some detail. The conclusions provide the current status of the INF Treaty implementation and outlines some lessons which could be applied to future negotiations of this type. Intermediate-range Nuclear Forces, INF Treaty, GLCM, PIT, Pershing II missiles, Ground Launched Cruise Missiles, Dual Track Decision, Nuclear arms negotiations.« less

Surgery for limited-stage small-cell lung cancer.

PubMed

Barnes, Hayley; See, Katharine; Barnett, Stephen; Manser, Renée

2017-04-21

Current treatment guidelines for limited-stage small-cell lung cancer (SCLC) recommend concomitant platinum-based chemo-radiotherapy plus prophylactic cranial irradiation, based on the premise that SCLC disseminates early, and is chemosensitive. However, although there is usually a favourable initial response, relapse is common and the cure rate for limited-stage SCLC remains relatively poor. Some recent clinical practice guidelines have recommended surgery for stage 1 (limited) SCLC followed by adjuvant chemotherapy, but this recommendation is largely based on the findings of observational studies. To determine whether, in patients with limited-stage SCLC, surgical resection of cancer improves overall survival and treatment-related deaths compared with radiotherapy or chemotherapy, or a combination of radiotherapy and chemotherapy, or best supportive care. We performed searches on CENTRAL, MEDLINE, Embase, CINAHL, and Web of Science up to 11 January 2017. We handsearched review articles, clinical trial registries, and reference lists of retrieved articles. We included randomised controlled trials (RCTs) with adults diagnosed with limited-stage SCLC, confirmed by cytology or histology, and radiological assessment, considered medically suitable for resection and radical radiotherapy, which randomised participants to surgery versus any other intervention. We imported studies identified by the search into a reference manager database. We retrieved the full-text version of relevant studies, and two review authors independently extracted data. The primary outcome measures were overall survival and treatment-related deaths; and secondary outcome measures included loco-regional progression, quality of life, and adverse events. We included three trials with 330 participants. We judged the quality of the evidence as very low for all the outcomes. The quality of the data was limited by the lack of complete outcome reporting, unclear risk of bias in the methods in which the studies were conducted, and the age of the studies (> 20 years). The methods of cancer staging and types of surgical procedures, which do not reflect current practice, reduced our confidence in the estimation of the effect.Two studies compared surgery to radiation therapy, and in one study chemotherapy was administered to both arms. One study administered initial chemotherapy, then responders were randomised to surgery versus control; following, both groups underwent chest and whole brain irradiation.Due to the clinical heterogeneity of the trials, we were unable to pool results for meta-analysis.All three studies reported overall survival. One study reported a mean overall survival of 199 days in the surgical arm, compared to 300 days in the radiotherapy arm (P = 0.04). One study reported overall survival as 4% in the surgical arm, compared to 10% in the radiotherapy arm at two years. Conversely, one study reported overall survival at two years as 52% in the surgical arm, compared to 18% in the radiotherapy arm. However this difference was not statistically significant (P = 0.12).One study reported early postoperative mortality as 7% for the surgical arm, compared to 0% mortality in the radiotherapy arm. One study reported the difference in mean degree of dyspnoea as -1.2 comparing surgical intervention to radiotherapy, indicating that participants undergoing radiotherapy are likely to experience more dyspnoea. This was measured using a non-validated scale. Evidence from currently available RCTs does not support a role for surgical resection in the management of limited-stage small-cell lung cancer; however our conclusions are limited by the quality of the available evidence and the lack of contemporary data. The results of the trials included in this review may not be generalisable to patients with clinical stage 1 small-cell lung cancer carefully staged using contemporary staging methods. Although some guidelines currently recommend surgical resection in clinical stage 1 small-cell lung cancer, prospective randomised controlled trials are needed to determine if there is any benefit in terms of short- and long-term mortality and quality of life compared with chemo-radiotherapy alone.

18F-FDG micro-PET imaging for research investigations in the Octopus vulgaris: applications and future directions in invertebrate neuroscience and tissue regeneration.

PubMed

Zullo, Letizia; Buschiazzo, Ambra; Massollo, Michela; Riondato, Mattia; Democrito, Alessia; Marini, Cecilia; Benfenati, Fabio; Sambuceti, Gianmario

2018-03-09

This study aimed at developing a method for administration of 18 F-Fludeoxyglucose ( 18 F-FDG) in the common octopus and micro-positron emission tomography (micro-PET) bio-distribution assay for the characterization of glucose metabolism in body organs and regenerating tissues. Methods: Seven animals (two with one regenerating arm) were anesthetized with 3.7% MgCl 2 in artificial seawater. Each octopus was injected with 18-30 MBq of isosmotic 18 F-FDG by accessing the branchial heart or the anterior vena cava. After an uptake time of ~50 minutes, the animal was sacrificed, placed on a bed of a micro-PET scanner and submitted to 10 min static 3-4 bed acquisitions to visualize the entire body. To confirm the interpretation of images, internal organs of interest were collected. The level of radioactivity of each organ was counted with a γ-counter. Results: Micro-PET scanning documented a good 18 F-FDG full body distribution following vena cava administration. A high mantle mass radioactivity facing a relatively low tracer uptake in the arms was revealed. In particular, the following organs were clearly identified and measured for their uptake: brain (standardized uptake value, SUV max of 6.57±1.86), optic lobes (SUV max of 7.59±1.66) and arms (SUV max of 1.12±0.06). Interestingly, 18 F-FDG uptake was up to threefold higher in the regenerating arm stumps at the level of highly proliferating areas. Conclusion: This study represents a stepping-stone over the use of non-invasive functional techniques to address questions relevant to invertebrate neuroscience and regenerative medicine. Copyright © 2018 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

CO2-dependent metabolic modulation in red blood cells stored under anaerobic conditions

PubMed Central

Dumont, Larry J.; D'Alessandro, Angelo; Szczepiorkowski, Zbigniew M.; Yoshida, Tatsuro

2015-01-01

Background Anaerobic RBC storage reduces oxidative damage, maintains ATP & 2,3-diphosphoglycerate (DPG) levels and has superior 24hr recovery at 6weeks compared to standard storage. This study will determine if removal of CO2 during O2 depletion by gas exchange may affect RBC during anaerobic storage. Methods This is a matched 3 arm study (n=14): control, O2&CO2 depleted with Ar (AN), O2 depleted with 95%Ar/5%CO2 (AN[CO2]). RBC in additives AS-3 or OFAS3 were evenly divided into 3 bags, and anaerobic conditions were established by gas exchange. Bags were stored 1-6°C in closed chambers under anaerobic conditions or ambient air, sampled weekly for up to 9weeks for a panel of in vitro tests. A full metabolomics screening was conducted for the first 4 weeks of storage. Results Purging with Ar (AN) results in alkalization of the RBC and increased glucose consumption. The addition of 5%CO2 to the purging gas prevented CO2 loss with an equivalent starting and final pH and lactate to control bags (p>0.5, days0-21). ATP levels are higher in AN[CO2] (p<0.0001). DPG was maintained beyond 2 weeks in the AN arm (p<0.0001). Surprisingly, DPG was lost at the same rate in both control and AN[CO2] arms (p=0.6). Conclusion Maintenance of ATP in the AN[CO2] arm demonstrates that ATP production is not solely a function of the pH effect on glycolysis. CO2 in anaerobic storage prevented the maintenance of DPG, and DPG production appears to be pH dependent. CO2 as well as O2 depletion provides metabolic advantage for stored RBC. PMID:26477888

When community reintegration is not the best option: interethnic violence and the trauma of parental loss in South Sudan.

PubMed

Muller, Brigitte; Munslow, Barry; O'Dempsey, Tim

2017-01-01

The magnitude of violence and human loss in conflict settings often exceeds the caring capacity of traditional support systems for orphans. The aim of this study is to understand the developmental context for children experiencing armed conflict, parental loss, extreme poverty, violence and social exclusion in a setting affected by interethnic violence. This article challenges the received wisdom that community reintegration is always better than institutional provision. Using a case study employing interviews, focus groups, workshops and observations, we examined how children's experiences of armed violence and parental loss affected their mental well-being, and their relationships within their community. Emerging findings such as experienced violence and psychological distress were further investigated using a cross-sectional survey design to explore the generalisability or transferability of theories or conclusions drawn from qualitative data. Findings showed that parental loss had a major impact on children's lives in the context of armed violence. Four main outcomes of orphanhood emerged: (i) facing the situation and evading harm (feelings of rejection and stigmatisation); (ii) trauma exposure and mental health effects (associations of orphanhood with adverse mental health outcomes and the number and type of experienced trauma); (iii) dealing with psychological distress (seeking caring connections and decreased feelings of isolation); and (iv) education and acceptance (increasing knowledge, skills and attitude and being respected in their community). We discuss the role that contexts such as armed violence, parental loss and social exclusion play for children's mental well-being and their implications for psychosocial interventions and orphan care in humanitarian settings. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Delayed Psychological Morbidity Associated with Snakebite Envenoming

PubMed Central

Williams, Shehan S.; Wijesinghe, Chamara A.; Jayamanne, Shaluka F.; Buckley, Nicholas A.; Dawson, Andrew H.; Lalloo, David G.; de Silva, H. Janaka

2011-01-01

Introduction The psychological impact of snakebite on its victims, especially possible late effects, has not been systematically studied. Objectives To assess delayed somatic symptoms, depressive disorder, post-traumatic stress disorder (PTSD), and impairment in functioning, among snakebite victims. Methods The study had qualitative and quantitative arms. In the quantitative arm, 88 persons who had systemic envenoming following snakebite from the North Central Province of Sri Lanka were randomly identified from an established research database and interviewed 12 to 48 months (mean 30) after the incident. Persons with no history of snakebite, matched for age, sex, geograpical location and occupation, acted as controls. A modified version of the Beck Depression Inventory, Post-Traumatic Stress Symptom Scale, Hopkins Somatic Symptoms Checklist, Sheehan Disability Inventory and a structured questionnaire were administered. In the qualitative arm, focus group discussions among snakebite victims explored common somatic symptoms attributed to envenoming. Results Previous snakebite victims (cases) had more symptoms than controls as measured by the modified Beck Depression Scale (mean 19.1 Vs 14.4; p<0.001) and Hopkins Symptoms Checklist (38.9 vs. 28.2; p<0.001). 48 (54%) cases met criteria for depressive disorder compared to 13 (15%) controls. 19 (21.6%) cases also met criteria for PTSD. 24 (27%) claimed that the snakebite caused a negative change in their employment; nine (10.2%) had stopped working and 15 (17%) claimed residual physical disability. The themes identified in the qualitative arm included blindness, tooth decay, body aches, headaches, tiredness and weakness. Conclusions Snakebite causes significant ongoing psychological morbidity, a complication not previously documented. The economic and social impacts of this problem need further investigation. PMID:21829741

Aripiprazole for the treatment of methamphetamine dependence: A randomized, double-blind, placebo-controlled trial

PubMed Central

Santos, GM; Das, M; Santos, DM; Huffaker, S; Matheson, T; Gasper, J; Vittinghoff, E; Colfax, GN

2012-01-01

Aims To test aripiprazole for efficacy in decreasing use in methamphetamine-dependent adults, compared to placebo. Design Participants were randomized to receive 12 weeks of aripiprazole or placebo, with a 3 month follow-up and a platform of weekly 30-minute substance abuse counseling. Setting The trial was conducted from January 2009 to March 2012 at the San Francisco Department of Public Health. Participants Ninety actively-using, methamphetamine-dependent, sexually active, adults were recruited from community venues. Measurements The primary outcome was regression estimated reductions in weekly methamphetamine-positive urines. Secondary outcomes were study medication adherence (by self-report and medication event monitoring systems [MEMS]), sexual risk behavior, and abstinence from methamphetamine. Findings Participant mean age was 38.7 years, 87.8% were male, 50.0% white, 18.9% African-American, and 16.7% Latino. Eighty-three percent of follow-up visits and final visits were completed. By intent-to-treat, participants assigned to aripiprazole had similar reductions in methamphetamine-positive urines as participants assigned to placebo (RR 0.88, 95% CI 0.66–1.19, P=0.41). Urine positivity declined from 73%(33/45 participants) to 45%(18/40) in the placebo arm, and from 77% (34/44) to 44% (20/35) in the aripiprazole arm. Adherence by MEMS and self-report was 42% and 74%, respectively, with no significant difference between arms (MEMS P=0.31; self-report P=0.17). Most sexual risk behaviors declined similarly among participants in both arms (all P>0.05). There were no serious adverse events related to study drug, although participants randomized to aripiprazole reported more akathisia, fatigue, and drowsiness (P<0.05). Conclusion Compared with placebo, aripiprazole did not significantly reduce methamphetamine use among actively-using, dependent adults. PMID:23186131

Everolimus Is Associated With Less Weight Gain Than Tacrolimus 2 Years After Liver Transplantation: Results of a Randomized Multicenter Study

PubMed Central

Charlton, Michael; Rinella, Mary; Patel, Dharmesh; McCague, Kevin; Heimbach, Julie; Watt, Kymberly

2017-01-01

Background Weight gain early after transplant is a risk factor for posttransplant metabolic syndrome (PTMS), cardiovascular events, and renal insufficiency. The impact of mammalian target of rapamycin inhibition on posttransplant weight gain and the development of PTMS components postliver transplantation were examined in a randomized, controlled study. Methods After a run-in period, patients (N = 719) were randomized at 30 ± 5 days posttransplant in a 1:1:1 ratio to 3 treatment groups: (i) everolimus (EVR) + reduced tacrolimus (TAC) (n = 245); (ii) TAC control (n = 243) or (iii) TAC elimination (n = 231). In this post hoc analysis, weight change at 12 and 24 months was compared between groups. Vital signs, lipids, and laboratory parameters at 12 and 24 months and rates of PTMS were assessed. Results Mean increase in weight from baseline was higher at month 12 in the TAC control arm (8.15 ± 9.27 kg) than in the EVR + reduced TAC (5.88 ± 12.60 kg, P = 0.056) and the TAC elimination arms (4.76 ± 9.94 kg, P = 0.007). At month 24, the TAC control arm displayed a significantly greater weight increase (9.54 ± 10.21 kg) than either the EVR + reduced TAC (6.69 ± 8.37 kg, P = 0.011) or the TAC elimination groups (6.01 ± 9.98 kg, P = 0.024). Rates of PTMS were similar for the EVR + reduced TAC (71.8%), TAC elimination (70.3%) and TAC control (67.4%) arms (P = NS). Conclusions EVR with reduced-exposure TAC attenuated weight gain at 1 and 2 years posttransplant compared with a standard TAC immunosuppression regimen. Rates of PTMS were comparable between EVR-containing and TAC control regimens. PMID:28817434

Phase II Trial of Cetuximab With or Without Paclitaxel in Patients With Advanced Urothelial Tract Carcinoma

PubMed Central

Wong, Yu-Ning; Litwin, Samuel; Vaughn, David; Cohen, Seth; Plimack, Elizabeth R.; Lee, James; Song, Wei; Dabrow, Michael; Brody, Marion; Tuttle, Holly; Hudes, Gary

2012-01-01

Purpose The benefit of salvage chemotherapy is modest in metastatic urothelial cancer. We conducted a randomized, noncomparative phase II study to measure the efficacy of cetuximab with or without paclitaxel in patients with previously treated urothelial cancer. Patients and Methods Patients with metastatic urothelial cancer who received one line of chemotherapy in the perioperative or metastatic setting were randomly assigned to 4-week cycles of cetuximab 250 mg/m2 with or without paclitaxel 80 mg/m2 per week. We used early progression as an indicator of futility. Either arm would close if seven of the initial 15 patients in that arm progressed at the first disease evaluation at 8 weeks. Results We enrolled 39 evaluable patients. The single-agent cetuximab arm closed after nine of the first 11 patients progressed by 8 weeks. The combination arm completed the full accrual of 28 patients, of whom 22 patients (78.5%) had visceral disease. Twelve of 28 patients had progression-free survival greater than 16 weeks. The overall response rate was 25% (95% CI, 11% to 45%; three complete responses and four partial responses). The median progression-free survival was 16.4 weeks (95% CI, 12 to 25.1 weeks), and the median overall survival was 42 weeks (95% CI, 30.4 to 78 weeks). Treatment-related grade 3 and 4 adverse events that occurred in at least two patients were rash (six cases), fatigue (five cases), and low magnesium (three cases). Conclusion Although it had limited activity as a single agent, cetuximab appears to augment the antitumor activity of paclitaxel in previously treated urothelial cancers. The cetuximab and paclitaxel combination merits additional study to establish its role in the treatment of urothelial cancers. PMID:22927525

Effects of antenatal care and HIV treatment integration on elements of the PMTCT cascade: Results from the SHAIP cluster-randomized controlled trial in Kenya

PubMed Central

Turan, Janet M.; Onono, Maricianah; Steinfeld, Rachel L.; Shade, Starley B.; Owuor, Kevin; Washington, Sierra; Bukusi, Elizabeth A.; Ackers, Marta L.; Kioko, Jackson; Interis, Evelyn C.; Cohen, Craig R.

2015-01-01

Background Integrating antenatal care (ANC) and HIV care may improve uptake and retention in services along the prevention of mother-to-child transmission (PMTCT) cascade. The current study aimed to determine if integration of HIV services into ANC settings improves PMTCT service utilization outcomes. Methods ANC clinics in rural Kenya were randomized to integrated (6 clinics, 569 women) or non-integrated (6 clinics, 603 women) services. Intervention clinics provided all HIV services, including highly active antiretroviral therapy (HAART), while control clinics provided PMTCT services but referred women to HIV care clinics within the same facility. PMTCT utilization outcomes among HIV-infected women (maternal HIV care enrollment, HAART initiation, and 3-month infant HIV testing uptake) were compared using generalized estimating equations and Cox regression. Results HIV care enrollment was higher in intervention compared to control clinics (69% versus 36%, Odds Ratio (OR)=3.94, 95% Confidence Interval (CI): 1.14–13.63). Median time to enrollment was significantly shorter among intervention arm women (0 versus 8 days, Hazard Ratio (HR)=2.20, 95% CI: 1.62–3.01). Eligible women in the intervention arm were more likely to initiate HAART (40% versus 17%, OR=3.22, 95% CI: 1.81–5.72). Infant testing was more common in the intervention arm (25% versus 18%), however not statistically different. No significant differences were detected in postnatal service uptake or maternal retention. Conclusions Service integration increased maternal HIV care enrollment and HAART uptake. However, PMTCT utilization outcomes were still suboptimal, and postnatal service utilization remained poor in both study arms. Further improvements in the PMTCT cascade will require additional research and interventions. PMID:25967269

FemZone trial: a randomized phase II trial comparing neoadjuvant letrozole and zoledronic acid with letrozole in primary breast cancer patients

PubMed Central

2014-01-01

Background The objective of this prospectively randomized phase II trial (Trial registration: EUCTR2004-004007-37-DE) was to compare the clinical response of primary breast cancer patients to neoadjuvant therapy with letrozole alone (LET) or letrozole and zoledronic acid (LET + ZOL). Methods Patients were randomly assigned to receive either LET 2.5 mg/day (n = 79) or the combination of LET 2.5 mg/day and a total of seven infusions of ZOL 4 mg every 4 weeks (n = 89) for 6 months. Primary endpoint was clinical response rate as assessed by mammogram readings. The study was terminated prematurely due to insufficient recruitment. We report here on an exploratory analysis of this data. Results Central assessment of tumor sizes during the treatment period was available for 131 patients (66 LET, 65 LET + ZOL). Clinical responses (complete or partial) were seen in 54.5% (95% CI: 41.8-66.9) of the patients in the LET arm and 69.2% (95% CI: 56.6-80.1) of those in the LET + ZOL arm (P = 0.106). A multivariate model showed an OR of 1.72 (95% CI: 0.83-3.59) for the experimental arm. Conclusion No increase in the clinical response rate was observed with the addition of ZOL to a neoadjuvant treatment regimen with LET. However a trend towards a better reponse in the LET + ZOL arm could be observed. This trend is consistent with previous studies that have investigated the addition of ZOL to chemotherapy, and it may support the evidence for a direct antitumor action of zoledronic acid. PMID:24499441

Relationship between distal radius fracture malunion and arm-related disability: A prospective population-based cohort study with 1-year follow-up

PubMed Central

2011-01-01

Background Distal radius fracture is a common injury and may result in substantial dysfunction and pain. The purpose was to investigate the relationship between distal radius fracture malunion and arm-related disability. Methods The prospective population-based cohort study included 143 consecutive patients above 18 years with an acute distal radius fracture treated with closed reduction and either cast (55 patients) or external and/or percutaneous pin fixation (88 patients). The patients were evaluated with the disabilities of the arm, shoulder and hand (DASH) questionnaire at baseline (concerning disabilities before fracture) and one year after fracture. The 1-year follow-up included the SF-12 health status questionnaire and clinical and radiographic examinations. Patients were classified into three hypothesized severity categories based on fracture malunion; no malunion, malunion involving either dorsal tilt (>10 degrees) or ulnar variance (≥1 mm), and combined malunion involving both dorsal tilt and ulnar variance. Multivariate regression analyses were performed to determine the relationship between the 1-year DASH score and malunion and the relative risk (RR) of obtaining DASH score ≥15 and the number needed to harm (NNH) were calculated. Results The mean DASH score at one year after fracture was significantly higher by a minimum of 10 points with each malunion severity category. The RR for persistent disability was 2.5 if the fracture healed with malunion involving either dorsal tilt or ulnar variance and 3.7 if the fracture healed with combined malunion. The NNH was 2.5 (95% CI 1.8-5.4). Malunion had a statistically significant relationship with worse SF-12 score (physical health) and grip strength. Conclusion Malunion after distal radius fracture was associated with higher arm-related disability regardless of age. PMID:21232088

Integration of Gravitational Torques in Cerebellar Pathways Allows for the Dynamic Inverse Computation of Vertical Pointing Movements of a Robot Arm

PubMed Central

Gentili, Rodolphe J.; Papaxanthis, Charalambos; Ebadzadeh, Mehdi; Eskiizmirliler, Selim; Ouanezar, Sofiane; Darlot, Christian

2009-01-01

Background Several authors suggested that gravitational forces are centrally represented in the brain for planning, control and sensorimotor predictions of movements. Furthermore, some studies proposed that the cerebellum computes the inverse dynamics (internal inverse model) whereas others suggested that it computes sensorimotor predictions (internal forward model). Methodology/Principal Findings This study proposes a model of cerebellar pathways deduced from both biological and physical constraints. The model learns the dynamic inverse computation of the effect of gravitational torques from its sensorimotor predictions without calculating an explicit inverse computation. By using supervised learning, this model learns to control an anthropomorphic robot arm actuated by two antagonists McKibben artificial muscles. This was achieved by using internal parallel feedback loops containing neural networks which anticipate the sensorimotor consequences of the neural commands. The artificial neural networks architecture was similar to the large-scale connectivity of the cerebellar cortex. Movements in the sagittal plane were performed during three sessions combining different initial positions, amplitudes and directions of movements to vary the effects of the gravitational torques applied to the robotic arm. The results show that this model acquired an internal representation of the gravitational effects during vertical arm pointing movements. Conclusions/Significance This is consistent with the proposal that the cerebellar cortex contains an internal representation of gravitational torques which is encoded through a learning process. Furthermore, this model suggests that the cerebellum performs the inverse dynamics computation based on sensorimotor predictions. This highlights the importance of sensorimotor predictions of gravitational torques acting on upper limb movements performed in the gravitational field. PMID:19384420

Apnea after awake-regional and general anesthesia in infants: The General Anesthesia compared to Spinal anesthesia (GAS) study: comparing apnea and neurodevelopmental outcomes, a randomized controlled trial

PubMed Central

Davidson, Andrew J.; Morton, Neil S.; Arnup, Sarah J.; de Graaff, Jurgen C.; Disma, Nicola; Withington, Davinia E.; Frawley, Geoff; Hunt, Rodney W.; Hardy, Pollyanna; Khotcholava, Magda; von Ungern Sternberg, Britta S.; Wilton, Niall; Tuo, Pietro; Salvo, Ida; Ormond, Gillian; Stargatt, Robyn; Locatelli, Bruno Guido; McCann, Mary Ellen

2015-01-01

Background Post-operative apnea is a complication in young infants. Awake-regional anesthesia (RA) may reduce the risk; however the evidence is weak. The General Anesthesia compared to Spinal anesthesia (GAS) study is a randomized, controlled, trial designed to assess the influence of general anesthesia (GA) on neurodevelopment. A secondary aim is to compare rates of apnea after anesthesia. Methods Infants ≤ 60 weeks postmenstrual age scheduled for inguinal herniorraphy were randomized to RA or GA. Exclusion criteria included risk factors for adverse neurodevelopmental outcome and infants born < 26 weeks’ gestation. The primary outcome of this analysis was any observed apnea up to 12 hours post-operatively. Apnea assessment was unblinded. Results 363 patients were assigned to RA and 359 to GA. Overall the incidence of apnea (0 to 12 hours) was similar between arms (3% in RA and 4% in GA arms, Odds Ratio (OR) 0.63, 95% Confidence Intervals (CI): 0.31 to 1.30, P=0.2133), however the incidence of early apnea (0 to 30 minutes) was lower in the RA arm (1% versus 3%, OR 0.20, 95%CI: 0.05 to 0.91, P=0.0367). The incidence of late apnea (30 minutes to 12 hours) was 2% in both RA and GA arms (OR 1.17, 95%CI: 0.41 to 3.33, P=0.7688). The strongest predictor of apnea was prematurity (OR 21.87, 95% CI 4.38 to 109.24) and 96% of infants with apnea were premature. Conclusions RA in infants undergoing inguinal herniorraphy reduces apnea in the early post-operative period. Cardio-respiratory monitoring should be used for all ex-premature infants. PMID:26001033

Acute effects of bergamot oil on anxiety-related behaviour and corticosterone level in rats.

PubMed

Saiyudthong, Somrudee; Marsden, Charles A

2011-06-01

Bergamot essential oil (BEO), Citrus aurantium subsp. bergamia (Risso) Wright & Arn. (Rutaceae), is used widely in aromatherapy to reduce stress and anxiety despite limited scientific evidence. A previous study showed that BEO significantly increased gamma-aminobutyric acid levels in rat hippocampus, suggesting potential anxiolytic properties. The aim of this study was to investigate the effect of BEO (1.0%, 2.5% and 5.0% w/w) administered to rats on both anxiety-related behaviours (the elevated plus-maze (EPM) and hole-board tests) and stress-induced levels of plasma corticosterone in comparison with the effects of diazepam. Inhalation of BEO (1% and 2.5%) and injection of diazepam (1 mg/kg, i.p.) significantly increased the percentage of open arm entries on the EPM. The percentage time spent in the open arms was also significantly enhanced following administration of either BEO (2.5% and 5%) or diazepam. Total arm entries were significantly increased with the highest dose (5%), suggesting an increase in locomotor activity. In the hole-board test, 2.5% BEO and diazepam significantly increased the number of head dips. 2.5% BEO and diazepam attenuated the corticosterone response to acute stress caused by exposure to the EPM. In conclusion, both BEO and diazepam exhibited anxiolytic-like behaviours and attenuated HPA axis activity by reducing the corticosterone response to stress. Copyright © 2010 John Wiley & Sons, Ltd.

Haemoglobin and anaemia in the SMART study

PubMed Central

Mocroft, A; Lifson, AR; Touloumi, G; Neuhaus, J; Fox, Z; Palfreeman, A; Vjecha, M; Hodder, S; De Wit, S; Lundgren, JD; Phillips, AN

2014-01-01

Background Data from randomized trials on the development of anaemia after interruption of therapy is not well described. Methods 2248 patients from the SMART study were included. We used Cox proportional hazards models to investigate development of new (≤12 mg/dl for females, ≤14 mg/dl for males) or worsening (≤8 mg/dl if anaemic at randomization) anaemia and poisson regression analyses to explore the relationship between anaemia and the development of AIDS, death or non-AIDS events. Results 759 patients developed new or worsening anaemia; 420/1106 (38.0%) in the drug conservation (DC) arm and 339/1127 (30.1%) in the virologic suppression (VS) arm; p<0.0001. At 4 months after randomization, patients in the DC arm had a significantly increased risk of developing new or worsening anaemia (adjusted relative hazard 1.56, 95% CI 1.28–1.89). Currently anaemic patients had an increased incidence of AIDS (adjusted IRR 2.31; 95% CI 1.34–3.98), death (2.19; 95% CI 1.23–3.87) and non-AIDS events (2.98; 95% CI 2.01–4.40) compared to non-anaemic patients. Conclusions Patients who interrupted cART had a higher risk of new or worsening anaemia. Anaemic patients had a higher incidence of AIDS, non-AIDS defining events or deaths, possibly due to deteriorating health and subclinical disease. PMID:21555815

Quantification of Upper Limb Motor Recovery and EEG Power Changes after Robot-Assisted Bilateral Arm Training in Chronic Stroke Patients: A Prospective Pilot Study

PubMed Central

Geroin, Christian; Bortolami, Marta; Saltuari, Leopold; Manganotti, Paolo

2018-01-01

Background Bilateral arm training (BAT) has shown promise in expediting progress toward upper limb recovery in chronic stroke patients, but its neural correlates are poorly understood. Objective To evaluate changes in upper limb function and EEG power after a robot-assisted BAT in chronic stroke patients. Methods In a within-subject design, seven right-handed chronic stroke patients with upper limb paresis received 21 sessions (3 days/week) of the robot-assisted BAT. The outcomes were changes in score on the upper limb section of the Fugl-Meyer assessment (FM), Motricity Index (MI), and Modified Ashworth Scale (MAS) evaluated at the baseline (T0), posttraining (T1), and 1-month follow-up (T2). Event-related desynchronization/synchronization were calculated in the upper alpha and the beta frequency ranges. Results Significant improvement in all outcomes was measured over the course of the study. Changes in FM were significant at T2, and in MAS at T1 and T2. After training, desynchronization on the ipsilesional sensorimotor areas increased during passive and active movement, as compared with T0. Conclusions A repetitive robotic-assisted BAT program may improve upper limb motor function and reduce spasticity in the chronically impaired paretic arm. Effects on spasticity were associated with EEG changes over the ipsilesional sensorimotor network. PMID:29780410

Crippling Violence: Conflict and Incident Polio in Afghanistan

PubMed Central

Norris, Alison; Hachey, Kevin; Curtis, Andrew; Bourdeaux, Margaret

2016-01-01

Background Designing effective public health campaigns in areas of armed conflict requires a nuanced understanding of how violence impacts the epidemiology of the disease in question. Methods We examine the geographical relationship between violence (represented by the location of detonated Improvised Explosive Devices) and polio incidence by generating maps of IEDs and polio incidence during 2010, and by comparing the mean number of IED detonations in polio high-risk districts with non polio high-risk districts during 2004–2009. Results We demonstrate a geographic relationship between IED violence and incident polio. Districts that have high-risk for polio have highly statistically significantly greater mean numbers of IEDs than non polio high-risk districts (p-values 0.0010–0.0404). Conclusions The geographic relationship between armed conflict and polio incidence provides valuable insights as to how to plan a vaccination campaign in violent contexts, and allows us to anticipate incident polio in the regions of armed conflict. Such information permits vaccination planners to engage interested armed combatants to co-develop strategies to mitigate the effects of violence on polio. PMID:26958854

Kinematics of symmetric Galactic longitudes to probe the spiral arms of the Milky Way with Gaia

NASA Astrophysics Data System (ADS)

Antoja, T.; Roca-Fàbrega, S.; de Bruijne, J.; Prusti, T.

2016-05-01

Aims: We model the effects of the spiral arms of the Milky Way on the disk stellar kinematics in the Gaia observable space. We also estimate the Gaia capabilities of detecting the predicted signatures. Methods: We use both controlled orbital integrations in analytic potentials and self-consistent simulations. We introduce a new strategy to investigate the effects of spiral arms, which consists of comparing the stellar kinematics of symmetric Galactic longitudes (+l and -l), in particular the median transverse velocity as determined from parallaxes and proper motions. This approach does not require the assumption of an axisymmetric model because it involves an internal comparison of the data. Results: The typical differences between the transverse velocity in symmetric longitudes in the models are of the order of ~2 km s-1, but can be larger than 10 km s-1 for certain longitudes and distances. The longitudes close to the Galactic centre and to the anti-centre are those with larger and smaller differences, respectively. The differences between the kinematics for +l and -l show clear trends that depend strongly on the properties of spiral arms. Thus, this method can be used to quantify the importance of the effects of spiral arms on the orbits of stars in the different regions of the disk, and to constrain the location of the arms, main resonances and, thus, pattern speed. Moreover, the method allows us to test different origin scenarios of spiral arms and the dynamical nature of the spiral structure (e.g. grand design versus transient multiple arms). We estimate the number of stars of each spectral type that Gaia will observe in certain representative Galactic longitudes, their characteristic errors in distance and transverse velocity, and the error in computing the median velocity as a function of distance. We will be able to measure the median transverse velocity exclusively with Gaia data, with precision smaller than ~1 km s-1 up to distances of ~4-6 kpc for certain giant stars, and up to ~2-4 kpc and better kinematic precision (≲0.5 km s-1) for certain sub-giants and dwarfs. These are enough to measure the typical signatures seen in the models. Conclusions: The Gaia catalogue will allow us to use the presented approach successfully and improve significantly upon current studies of the dynamics of the spiral arms of our Galaxy. We also show that a similar strategy can be used with line-of-sight velocities, which could be applied to Gaia data and to upcoming spectroscopic surveys.

Neuropsychological Outcome of Children Treated for Standard Risk Medulloblastoma in the PNET4 European Randomized Controlled Trial of Hyperfractionated Versus Standard Radiation Therapy and Maintenance Chemotherapy

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

Câmara-Costa, Hugo, E-mail: hugocamaracosta@gmail.com; Resch, Anika; Kieffer, Virginie

Purpose: In the European HIT-SIOP PNET4 randomized controlled trial, children with standard risk medulloblastoma were allocated to hyperfractionated radiation therapy (HFRT arm, including a partially focused boost) or standard radiation therapy (STRT arm), followed, in both arms, by maintenance chemotherapy. Event-free survival was similar in both arms. Previous work showed that the HFRT arm was associated with worse growth and better questionnaire-based executive function, especially in children <8 years of age at diagnosis. Therefore, the aim of this study was to compare performance-based cognitive outcomes between treatment arms. Methods and Materials: Neuropsychological data were collected prospectively in 137 patients. Using themore » Wechsler Intelligence Scales, Kaufman Assessment Battery for Children, and Raven's Progressive Matrices, we estimated full-scale intelligence quotient (FSIQ) and, when available, verbal IQ (VIQ), performance IQ (PIQ), working memory index (WMI), and processing speed index (PSI). Results: Among the 137 participants (HFRT arm n=71, STRT arm n=66, 63.5% males), mean (±SD) ages at diagnosis and assessment respectively were 9.3 (±3.2) years of age (40.8% < 8 years of age at diagnosis) and 14.6 (±4.3) years of age. Mean (±SD) FSIQ was 88 (±19), and mean intergroup difference was 3.88 (95% confidence interval: −2.66 to 10.42, P=.24). No significant differences were found in children >8 years of age at diagnosis. In children <8 years of age at diagnosis, a marginally significant trend toward higher VIQ was found in those treated in the HFRT arm; a similar trend was found for PSI but not for PIQ, WMI, or FSIQ (mean intergroup differences were: 12.02 for VIQ [95% CI: 2.37-21.67; P=.02]; 3.77 for PIQ [95% CI: −5.19 to 12.74; P>.10]; 5.20 for WMI [95% CI: −2.07 to 12.47; P>.10]; 10.90 for PSI [95% CI: −1.54 to 23.36; P=.08]; and 5.28 for FSIQ [95% CI: −4.23 to 14.79; P>.10]). Conclusions: HFRT was associated with marginally higher VIQ in children <8 years of age at diagnosis, consistent with a previous report using questionnaire-based data. However, overall cognitive ability was not significantly different.« less

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

Whole brain C-arm computed tomography parenchymal blood volume measurements

PubMed Central

Byrne, James V

2016-01-01

Introduction C-arm flat detector computed tomography (FDCT) parenchymal blood volume (PBV) imaging in the neuro-interventional suite is a new technique for which detailed whole brain measurements have not been previously reported. This study aims to create a catalogue of PBV measurements for various anatomical regions encompassing the whole brain, using a three-dimensional volume-of-interest (3D-VOI) analysis. Methods We acquired and analysed 30 C-arm FDCT datasets from 26 patients with aneurysmal subarachnoid haemorrhage (SAH), as part of a prospective study comparing C-arm computed tomography (CT) PBV with magnetic resonance perfusion-weighted imaging (MR-PWI). We calculated the PBV values for various brain regions with an automated analysis, using 58 pre-defined atlas-based 3D-VOIs encompassing the whole brain. VOIs partially or completely overlapping regions of magnetic resonance diffusion weighted imaging (MR-DWI) abnormality or magnetic resonance cerebral blood flow (MR-CBF) asymmetry were excluded from the analysis. Results Of the 30 C-arm CT PBV datasets, 14 (54%; 12 patients) had areas of restricted diffusion, the majority of which were focal. The PBV values for the cerebral cortex and cerebral white matter were 4.01 ± 0.47 (mean ± SD) and 3.01 ± 0.39 ml per 100 ml. Lobar PBV values were: frontal lobe 4.2 ± 0.8, temporal lobe 4.2 ± 0.9, parietal lobe 3.9 ± 0.7 and occipital lobe 4.3 ± 0.8 ml/100 ml. The basal ganglia and brainstem PBV values were 3.4 ± 0.7 and 4.6 ± 0.6 ml/100 ml, respectively. Conclusions Compared with the typical reference cerebral blood volume (CBV) values reported in the literature for Positron Emission Tomography (PET), the PBV values were relatively high for the white matter and relatively low for the cortical grey matter. The reported catalogue of PBV values for various brain regions would be useful to inform future studies and could be used in clinical practice, when interpreting PBV maps. PMID:26769737

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

The effect of unilateral arm swing motion on lower extremity running mechanics associated with injury risk.

PubMed

Agresta, Cristine; Ward, Christian R; Wright, W Geoffrey; Tucker, Carole A

2018-06-01

Many field sports involve equipment that restricts one or both arms from moving while running. Arm swing during running has been examined from a biomechanical and physiologic perspective but not from an injury perspective. Moreover, only bilateral arm swing suppression has been studied with respect to running. The purpose of this study was to determine the influence of running with one arm restrained on lower extremity mechanics associated with running or sport-related injury. Fifteen healthy participants ran at a self-selected speed with typical arm swing, with one arm restrained and with both arms restrained. Lower extremity kinematics and spatiotemporal measures were analysed for all arm swing conditions. Running with one arm restrained resulted in increased frontal plane knee and hip angles, decreased foot strike angle, and decreased centre of mass vertical displacement compared to typical arm swing or bilateral arm swing restriction. Stride length was decreased and step frequency increased when running with one or both arms restrained. Unilateral arm swing restriction induces changes in lower extremity kinematics that are not similar to running with bilateral arm swing restriction or typical arm swing motion. Running with one arm restrained increases frontal plane mechanics associated with risk of knee injury.

Can widespread hypersensitivity in carpal tunnel syndrome be substantiated if neck and arm pain are absent?

PubMed

Schmid, A B; Soon, B T C; Wasner, G; Coppieters, M W

2012-02-01

Recent studies demonstrated that patients with carpal tunnel syndrome (CTS) have signs of thermal and mechanical hyperalgesia in extra-median territories suggesting an involvement of central pain mechanisms. As previous studies included patients with shoulder/arm symptoms or neck pain, a potential influence of these coexisting disorders cannot be excluded. This study therefore evaluated whether widespread sensory changes (hypoesthesia or hyperalgesia) are present in patients with unilateral CTS in the absence of coexisting disorders. Twenty-six patients with unilateral CTS with symptoms localised to their hand and 26 healthy controls participated in the study. A comprehensive quantitative sensory testing (QST) protocol including thermal and mechanical detection and pain thresholds was performed over the hands (median, ulnar and radial innervation area), lateral elbows, neck and tibialis anterior muscle. Patients with CTS demonstrated thermal and mechanical hypoesthesia in the hand but not at distant sites. Thermal or mechanical hyperalgesia was not identified at any location with traditional QST threshold testing. However, patients with CTS rated the pain during thermal pain testing significantly higher than healthy participants. This was especially apparent for heat pain ratings which were elevated not only in the affected hand but also in the neck and tibialis anterior muscle. In conclusion, CTS alone in the absence of coexisting neck and arm pain does not account for sensory changes outside the affected hand as determined by traditional QST threshold testing. Elevated pain ratings may however be an early indication of central pain mechanisms. © 2011 European Federation of International Association for the Study of Pain Chapters.

Aid-Assisted Decision-Making and Colorectal Cancer Screening

PubMed Central

Schroy, Paul C.; Emmons, Karen M.; Peters, Ellen; Glick, Julie T.; Robinson, Patricia A.; Lydotes, Maria A.; Mylvaganam, Shamini R.; Coe, Alison M.; Chen, Clara A.; Chaisson, Christine E.; Pignone, Michael P.; Prout, Marianne N.; Davidson, Peter K.; Heeren, Timothy C.

2014-01-01

Background Shared decision-making (SDM) is a widely recommended yet unproven strategy for increasing colorectal cancer (CRC) screening uptake. Previous trials of decision aids to increase SDM and CRC screening uptake have yielded mixed results. Purpose To assess the impact of decision aid–assisted SDM on CRC screening uptake. Design RCT. Setting/participants The study was conducted at an urban, academic safety-net hospital and community health center between 2005 and 2010. Participants were asymptomatic, average-risk patients aged 50–75 years due for CRC screening. Intervention Study participants (n=825) were randomized to one of two intervention arms (decision aid plus personalized risk assessment or decision aid alone) or control arm. The interventions took place just prior to a routine office visit with their primary care providers. Main outcome measures The primary outcome was completion of a CRC screening test within 12 months of the study visit. Logistic regression was used to identify predictors of test completion and mediators of the intervention effect. Analysis was completed in 2011. Results Patients in the decision-aid group were more likely to complete a screening test than control patients (43.1% vs 34.8%; p=0.046) within 12 months of the study visit; conversely, test uptake for the decision aid and decision aid plus personalized risk assessment arms was similar (43.1% vs 37.1%; p=0.15). Assignment to the decision-aid arm (AOR 1.48; 95% CI=1.04, 2.10), black race (AOR 1.52, 95% CI=1.12, 2.06) and a preference for a patient-dominant decisionmaking approach (AOR, 1.55; 95% CI=1.02, 2.35) were independent determinants of test completion. Activation of the screening discussion and enhanced screening intentions mediated the intervention effect. Conclusions Decision aid–assisted SDM has a modest impact on CRC screening uptake. A decision aid plus personalized risk assessment tool is no more effective than a decision aid alone. PMID:23159252

Structural Studies of Three-Arm Star Block Copolymers Exposed to Extreme Stretch Suggests a Persistent Polymer Tube

NASA Astrophysics Data System (ADS)

Mortensen, Kell; Borger, Anine L.; Kirkensgaard, Jacob J. K.; Garvey, Christopher J.; Almdal, Kristoffer; Dorokhin, Andriy; Huang, Qian; Hassager, Ole

2018-05-01

We present structural small-angle neutron scattering studies of a three-armed polystyrene star polymer with short deuterated segments at the end of each arm. We show that the form factor of the three-armed star molecules in the relaxed state agrees with that of the random phase approximation of Gaussian chains. Upon exposure to large extensional flow conditions, the star polymers change conformation resulting in a highly stretched structure that mimics a fully extended three-armed tube model. All three arms are parallel to the flow, one arm being either in positive or negative stretching direction, while the two other arms are oriented parallel, right next to each other in the direction opposite to the first arm.

Phase 3 Trial of Postoperative Chemotherapy Alone Versus Chemoradiation Therapy in Stage III-IV Gastric Cancer Treated With R0 Gastrectomy and D2 Lymph Node Dissection

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

Kim, Tae Hyun; Park, Sook Ryun; Ryu, Keun Won

2012-12-01

Purpose: To compare chemotherapy alone with chemoradiation therapy in stage III-IV(M0) gastric cancer treated with R0 gastrectomy and D2 lymph node dissection. Methods and Materials: The chemotherapy arm received 5 cycles of fluorouracil and leucovorin (FL), and the chemoradiation therapy arm received 1 cycle of FL, then radiation therapy of 45 Gy concurrently with 2 cycles of FL, followed by 2 cycles of FL. Intent-to-treat analysis and per-protocol analyses were performed. Results: Between May 6, 2002 and June 29, 2006, a total of 90 patients were enrolled. Forty-four were randomly assigned to the chemotherapy arm and 46 to the chemoradiationmore » therapy arm. Treatment was completed as planned by 93.2% of patients in the chemotherapy arm and 87.0% in the chemoradiation therapy arm. Overall intent-to-treat analysis showed that addition of radiation therapy to chemotherapy significantly improved locoregional recurrence-free survival (LRRFS) but not disease-free survival. In subgroup analysis for stage III, chemoradiation therapy significantly prolonged the 5-year LRRFS and disease-free survival rates compared with chemotherapy (93.2% vs 66.8%, P=.014; 73.5% vs 54.6%, P=.056, respectively). Conclusions: Addition of radiation therapy to chemotherapy could improve the LRRFS in stage III gastric cancer treated with R0 gastrectomy and D2 lymph node dissection.« less

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

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

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

2012-06-01

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

The Inter-Arm Diastolic Blood Pressure Difference Induced by One Arm Ischemia: A New Approach to Assess Vascular Endothelia Function

PubMed Central

Su, Hai; Wang, Jiwei; Xu, Jinsong; Liu, Yanna; Huang, Ming; Cheng, Xiaoshu

2014-01-01

Objectives To evaluate whether inter-arm diastolic blood pressure difference (DBPl-r) induced by one arm ischemia correlates with flow-mediated dilatation (FMD). Methods Bilateral arm BPs were simultaneously measured with two automatic devices and right brachial artery diameter (D) was measured by ultrasound technique in 108 subjects (56 hypertensives and 52 normotensives). Following baseline diameter (D0) and BP measurement, right brachial artery was occluded for 5 minutes. The diameter was measured at 1, 1.5 and 2 min, and bilateral BPs measured at 3, 4 and 5 min after occlusion release. Their averages were recorded as post-D and post-BP, respectively. The difference between post-D and D0 (ΔD) was calculated as the percentage increase of artery diameter (ΔD/D0). The BP difference between left and right arms was calculated as BPl-r, and the difference of post- BPl-r and baseline BPl-r was recorded as the net change of BPl-r (ΔBPl-r). Results At baseline, bilateral SBPs and DBPs were similar. Right arm ischemia induced significant DBP decline only in the right arm (68.8±12.7 vs 72.6±12.0 mmHg, P<0.05), which led to an increase of ΔDBPl-r (4.00±3.75 vs 0.78±4.47 mmHg, P<0.05). A positive correlation was seen between ΔD/D0 and ΔDBPl-r (r = 0.744, p<0.001). Furthermore, the correlation between age and ΔDBPl-r (r = −0.358, P<0.01) was similar to that between age and D/D0 (r = −0.398, P<0.01). Meanwhile, both ΔDBPl-r and ΔD/D0 were significantly lower in hypertensive patients than in normotensive patients. Conclusion The inter-arm DBP difference induced by one arm ischemia may be a potential index for clinical evaluation of vascular endothelial function. PMID:24454748

An observational study of Donor Ex Vivo Lung Perfusion in UK lung transplantation: DEVELOP-UK.

PubMed

Fisher, Andrew; Andreasson, Anders; Chrysos, Alexandros; Lally, Joanne; Mamasoula, Chrysovalanto; Exley, Catherine; Wilkinson, Jennifer; Qian, Jessica; Watson, Gillian; Lewington, Oli; Chadwick, Thomas; McColl, Elaine; Pearce, Mark; Mann, Kay; McMeekin, Nicola; Vale, Luke; Tsui, Steven; Yonan, Nizar; Simon, Andre; Marczin, Nandor; Mascaro, Jorge; Dark, John

2016-11-01

Many patients awaiting lung transplantation die before a donor organ becomes available. Ex vivo lung perfusion (EVLP) allows initially unusable donor lungs to be assessed and reconditioned for clinical use. The objective of the Donor Ex Vivo Lung Perfusion in UK lung transplantation study was to evaluate the clinical effectiveness and cost-effectiveness of EVLP in increasing UK lung transplant activity. A multicentre, unblinded, non-randomised, non-inferiority observational study to compare transplant outcomes between EVLP-assessed and standard donor lungs. Multicentre study involving all five UK officially designated NHS adult lung transplant centres. Patients aged ≥ 18 years with advanced lung disease accepted onto the lung transplant waiting list. The study intervention was EVLP assessment of donor lungs before determining suitability for transplantation. The primary outcome measure was survival during the first 12 months following lung transplantation. Secondary outcome measures were patient-centred outcomes that are influenced by the effectiveness of lung transplantation and that contribute to the health-care costs. Lungs from 53 donors unsuitable for standard transplant were assessed with EVLP, of which 18 (34%) were subsequently transplanted. A total of 184 participants received standard donor lungs. Owing to the early closure of the study, a non-inferiority analysis was not conducted. The Kaplan-Meier estimate of survival at 12 months was 0.67 [95% confidence interval (CI) 0.40 to 0.83] for the EVLP arm and 0.80 (95% CI 0.74 to 0.85) for the standard arm. The hazard ratio for overall 12-month survival in the EVLP arm relative to the standard arm was 1.96 (95% CI 0.83 to 4.67). Patients in the EVLP arm required ventilation for a longer period and stayed longer in an intensive therapy unit (ITU) than patients in the standard arm, but duration of overall hospital stay was similar in both groups. There was a higher rate of very early grade 3 primary graft dysfunction (PGD) in the EVLP arm, but rates of PGD did not differ between groups after 72 hours. The requirement for extracorporeal membrane oxygenation (ECMO) support was higher in the EVLP arm (7/18, 38.8%) than in the standard arm (6/184, 3.2%). There were no major differences in rates of chest radiograph abnormalities, infection, lung function or rejection by 12 months. The cost of EVLP transplants is approximately £35,000 higher than the cost of standard transplants, as a result of the cost of the EVLP procedure, and the increased ECMO use and ITU stay. Predictors of cost were quality of life on joining the waiting list, type of transplant and number of lungs transplanted. An exploratory model comparing a NHS lung transplant service that includes EVLP and standard lung transplants with one including only standard lung transplants resulted in an incremental cost-effectiveness ratio of £73,000. Interviews showed that patients had a good understanding of the need for, and the processes of, EVLP. If EVLP can increase the number of usable donor lungs and reduce waiting, it is likely to be acceptable to those waiting for lung transplantation. Study limitations include small numbers in the EVLP arm, limiting analysis to descriptive statistics and the EVLP protocol change during the study. Overall, one-third of donor lungs subjected to EVLP were deemed suitable for transplant. Estimated survival over 12 months was lower than in the standard group, but the data were also consistent with no difference in survival between groups. Patients receiving these additional transplants experience a higher rate of early graft injury and need for unplanned ECMO support, at increased cost. The small number of participants in the EVLP arm because of early study termination limits the robustness of these conclusions. The reason for the increased PGD rates, high ECMO requirement and possible differences in lung injury between EVLP protocols needs evaluation. Current Controlled Trials ISRCTN44922411. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 20, No. 85. See the NIHR Journals Library website for further project information.

Hand washing with soap and water together with behavioural recommendations prevents infections in common work environment: an open cluster-randomized trial

PubMed Central

2012-01-01

Background Hand hygiene is considered as an important means of infection control. We explored whether guided hand hygiene together with transmission-limiting behaviour reduces infection episodes and lost days of work in a common work environment in an open cluster-randomized 3-arm intervention trial. Methods A total of 21 clusters (683 persons) were randomized to implement hand hygiene with soap and water (257 persons), with alcohol-based hand rub (202 persons), or to serve as a control (224 persons). Participants in both intervention arms also received standardized instructions on how to limit the transmission of infections. The intervention period (16 months) included the emergence of the 2009 influenza pandemic and the subsequent national hand hygiene campaign influencing also the control arm. Results In the total follow-up period there was a 6.7% reduction of infection episodes in the soap-and water arm (p = 0.04). Before the onset of the anti-pandemic campaign, a statistically significant (p = 0.002) difference in the mean occurrence of infection episodes was observed between the control (6.0 per year) and the soap-and-water arm (5.0 per year) but not between the control and the alcohol-rub arm (5.6 per year). Neither intervention had a decreasing effect on absence from work. Conclusions We conclude that intensified hand hygiene using water and soap together with behavioural recommendations can reduce the occurrence of self-reported acute illnesses in common work environment. Surprisingly, the occurrence of reported sick leaves also increased in the soap-and water-arm. Trial Registration ClinicalTrials.gov: NCT00981877 Source of funding The Finnish Work Environment Fund and the National Institute for Health and Welfare. PMID:22243622

Virtual Hand Illusion Induced by Visuomotor Correlations

PubMed Central

Sanchez-Vives, Maria V.; Spanlang, Bernhard; Frisoli, Antonio; Bergamasco, Massimo; Slater, Mel

2010-01-01

Background Our body schema gives the subjective impression of being highly stable. However, a number of easily-evoked illusions illustrate its remarkable malleability. In the rubber-hand illusion, illusory ownership of a rubber-hand is evoked by synchronous visual and tactile stimulation on a visible rubber arm and on the hidden real arm. Ownership is concurrent with a proprioceptive illusion of displacement of the arm position towards the fake arm. We have previously shown that this illusion of ownership plus the proprioceptive displacement also occurs towards a virtual 3D projection of an arm when the appropriate synchronous visuotactile stimulation is provided. Our objective here was to explore whether these illusions (ownership and proprioceptive displacement) can be induced by only synchronous visuomotor stimulation, in the absence of tactile stimulation. Methodology/Principal Findings To achieve this we used a data-glove that uses sensors transmitting the positions of fingers to a virtually projected hand in the synchronous but not in the asynchronous condition. The illusion of ownership was measured by means of questionnaires. Questions related to ownership gave significantly larger values for the synchronous than for the asynchronous condition. Proprioceptive displacement provided an objective measure of the illusion and had a median value of 3.5 cm difference between the synchronous and asynchronous conditions. In addition, the correlation between the feeling of ownership of the virtual arm and the size of the drift was significant. Conclusions/Significance We conclude that synchrony between visual and proprioceptive information along with motor activity is able to induce an illusion of ownership over a virtual arm. This has implications regarding the brain mechanisms underlying body ownership as well as the use of virtual bodies in therapies and rehabilitation. PMID:20454463

Effect of HIV self-testing on the number of sexual partners among female sex workers in Zambia

PubMed Central

Oldenburg, Catherine E.; Chanda, Michael M.; Ortblad, Katrina F.; Mwale, Magdalene; Chongo, Steven; Kamungoma, Nyambe; Kanchele, Catherine; Fullem, Andrew; Moe, Caitlin; Barresi, Leah G.; Harling, Guy D.; Bärnighausen, Till

2018-01-01

Objectives: To assess the effect of two health system approaches to distribute HIV self-tests on the number of female sex workers’ client and nonclient sexual partners. Design: Cluster randomized controlled trial. Methods: Peer educators recruited 965 participants. Peer educator–participant groups were randomized 1 : 1 : 1 to one of three arms: delivery of HIV self-tests directly from a peer educator, free facility-based delivery of HIV self-tests in exchange for coupons, or referral to standard-of-care HIV testing. Participants in all three arms completed four peer educator intervention sessions, which included counseling and condom distribution. Participants were asked the average number of client partners they had per night at baseline, 1 and 4 months, and the number of nonclient partners they had in the past 12 months (at baseline) and in the past month (at 1 month and 4 months). Results: At 4 months, participants reported significantly fewer clients per night in the direct delivery arm (mean difference −0.78 clients, 95% CI −1.28 to −0.28, P = 0.002) and the coupon arm (−0.71, 95% CI −1.21 to −0.21, P = 0.005) compared with standard of care. Similarly, they reported fewer nonclient partners in the direct delivery arm (−3.19, 95% CI −5.18 to −1.21, P = 0.002) and in the coupon arm (−1.84, 95% CI −3.81 to 0.14, P = 0.07) arm compared with standard of care. Conclusion: Expansion of HIV self-testing may have positive behavioral effects enhancing other HIV prevention efforts among female sex workers in Zambia. Trial Registration: ClinicalTrials.gov NCT02827240. PMID:29494424

A randomized trial of enhanced HIV risk reduction and vaccine trial education interventions among HIV-negative, high-risk women who use non-injection drugs: The UNITY Study

PubMed Central

Koblin, Beryl A.; Bonner, Sebastian; Hoover, Donald R.; Xu, Guozhen; Lucy, Debbie; Fortin, Princess; Putnam, Sara; Latka, Mary H.

2014-01-01

Background Limited data are available on interventions to reduce sexual risk behaviors and increase knowledge of HIV vaccine trial concepts in high risk populations eligible to participate in HIV vaccine efficacy trials. Methods The UNITY Study was a two-arm randomized trial to determine the efficacy of enhanced HIV risk reduction and vaccine trial education interventions to reduce the occurrence of unprotected vaginal sex acts and increase HIV vaccine trial knowledge among 311 HIV-negative non-injection drug using women. The enhanced vaccine education intervention using pictures along with application vignettes and enhanced risk reduction counseling consisting of three one-on-one counseling sessions were compared to standard conditions. Follow-up visits at one week and one, six and twelve months after randomization included HIV testing and assessment of outcomes. Results During follow up, the percent of women reporting sexual risk behaviors declined significantly, but did not differ significantly by study arm. Knowledge of HIV vaccine trial concepts significantly increased but did not significantly differ by study arm. Concepts about HIV vaccine trials not adequately addressed by either condition included those related to testing a vaccine for both efficacy and safety, guarantees about participation in future vaccine trials, assurances of safety, medical care, and assumptions about any protective effect of a test vaccine. Conclusions Further research is needed to boost educational efforts and strengthen risk reduction counseling among high-risk non-injection drug using women. PMID:20190585

Overload and neovascularization of shoulder tendons in volleyball players

PubMed Central

2012-01-01

Background In overhead sports like volleyball, the onset of a rotator cuff tendinopathy due to functional overload is a common observation. An angiofibroblastic etiopathogenesis has been hypothesized, whereby a greater anaerobic metabolism occurs in critical zones of the tendon with a lower degree of vascularization; this would induce collagen and extracellular matrix degradation, that could then trigger a compensatory neovascularization response. We performed a clinical observational study of 80 elite volleyball players, monitoring the perfusion values of the supraspinatus tendons by oximetry. Results No statistically significant differences were found between the oximetry data and age, sex or years of sports activity, nor when comparing the right and left arm or the dominant and non-dominant arm. A statistically significant difference was found for the dominant arm values in relation to the competitive role, higher values being obtained in outside hitters (62.7%) than middle hitters (53.7%) (p = 0.01), opposite hitters (55.5%) (p = 0.02) and libero players (54.4%) (p = 0.008), whereas there were no differences in setters (56.2%) (p > 0.05). Conclusions The different tendon vascularization values found in players with different roles in the team may be attributed to a response to the specific biomechanical demands posed by the different overhead throwing roles. PMID:22853746

Auto-SCT improves survival in systemic light chain amyloidosis: a retrospective analysis with 14-year follow-up.

PubMed

Parmar, S; Kongtim, P; Champlin, R; Dinh, Y; Elgharably, Y; Wang, M; Bashir, Q; Shah, J J; Shah, N; Popat, U; Giralt, S A; Orlowski, R Z; Qazilbash, M H

2014-08-01

Optimal treatment approach continues to remain a challenge for systemic light chain amyloidosis (AL). So far, Auto-SCT is the only modality associated with long-term survival. However, failure to show survival benefit in randomized study raises questions regarding its efficacy. We present a comparative outcome analysis of Auto-SCT to conventional therapies (CTR) in AL patients treated over a 14-year period at our institution. Out of the 145 AL amyloidosis patients, Auto-SCT was performed in 80 patients with 1-year non-relapse mortality rate of 12.5%. Novel agents were used as part of induction therapy in 56% of transplant recipients vs 46% of CTR patients. Hematological and organ responses were seen in 74.6% and 39% in the Auto-SCT arm vs 53% and 12% in the CTR arm, respectively. The projected 5-year survival for Auto-SCT vs CTR was 63% vs 38%, respectively. Landmark analysis of patients alive at 1-year after diagnosis showed improved 5-year OS of 72% with Auto-SCT vs 65% in the CTR arm. In the multivariate analysis, age <60 years, induction therapy with novel agents, kidney only involvement and Auto-SCT were associated with improved survival. In conclusion, Auto-SCT is associated with long-term survival for patients with AL amyloidosis.

A Phase 2 Randomized Study of Ramucirumab (IMC-1121B) with or without Dacarbazine in Patients with Metastatic Melanoma

PubMed Central

Carvajal, Richard D.; Wong, Michael K.; Thompson, John A.; Gordon, Michael S.; Lewis, Karl D.; Pavlick, Anna C.; Wolchok, Jedd D.; Rojas, Patrick B.; Schwartz, Jonathan D.; Bedikian, Agop Y.

2017-01-01

SUMMARY Background To evaluate the efficacy and safety of ramucirumab (IMC-1121B; LY3009806), a fully human monoclonal antibody targeting the vascular endothelial growth factor receptor-2, alone and in combination with dacarbazine in chemotherapy-naïve patients with metastatic melanoma (MM). Methods Eligible patients received ramucirumab (10 mg/kg) + dacarbazine (1000 mg/m2) (Arm A) or ramucirumab only (10 mg/kg) (Arm B) every 3 weeks. The primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS), overall response, and safety. Findings Of 106 randomized patients, 102 received study treatment (Arm A, N = 52; Arm B, N = 50). Baseline characteristics were similar in both arms. Median PFS was 2·6 months (Arm A) and 1·7 months (Arm B); median 6-month PFS rates were 30·7% and 17·9% and 12-month PFS rates were 23·7% and 15·6%, respectively. In Arm A, 9 (17·3%) patients had partial response (PR) and 19 (36·5%), stable disease (SD); PR and SD in Arm B were 2 (4·0%) and 21 (42·0%), respectively. Median OS was 8·7 months in Arm A and 11·1 months in Arm B. Patients in both arms tolerated the treatment with limited grade 3/4 toxicities. Interpretation Ramucirumab alone or in combination with dacarbazine was associated with an acceptable safety profile in patients with MM. Although the study was not powered for comparison between treatment arms, PFS appeared greater with combination therapy. Sustained disease control was observed on both study arm Funding Funded by ImClone Systems LLC, a wholly-owned subsidiary of Eli Lilly and Company, Bridgewater, NJ PMID:24930625

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

PubMed

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

2012-12-01

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

Facilitating mental health help-seeking by young adults with a dedicated online program: a feasibility study of Link

PubMed Central

Kauer, Sylvia D; Buhagiar, Kerrie; Blake, Victoria; Cotton, Sue; Sanci, Lena

2017-01-01

Objective To explore the feasibility of a dedicated online youth mental health help-seeking intervention and to evaluate using a randomised controlled trial (RCT) study design in order to identify any modifications needed before commencement of the full-scale RCT. Design A pilot RCT with 1:1 randomisation to either the intervention or comparison arm. Setting An online study conducted Australia-wide. Participants 18–25 year olds living in Australia were recruited via social media. Intervention Link is a dedicated online mental health help-seeking navigation tool that matches user’s mental health issues, severity and service-type preferences (online, phone and face-to-face) with appropriate youth-friendly services. The comparison arm was usual help-seeking strategies with a link to Google.com. Main outcome measures The primary outcome was the number of acceptability and feasibility criteria successfully met. Intervention and study design acceptability and feasibility were assessed by nine criteria. Secondary outcomes, via online surveys (at baseline, 1 week and 1 month) measured service use, help-seeking intentions, psychological distress, barriers to help-seeking, attitudes towards mental health help-seeking, mental health literacy, satisfaction and trust. Results Fifty-one participants were randomised (intervention: n=24; comparison: n=27). Three out of four of the intervention and two out of five of the study design criteria were met. Unmet criteria could be addressed by modifications to the study design. Qualitative analysis demonstrated that Link was useful to participants and may have increased their positive experiences towards help-seeking. There were no observable differences between arms in any outcome measures and no harms were detected. Conclusion Generally, the Link intervention and study design were acceptable and feasible with modifications suggested for the four out of nine unmet criteria. The main trial will hence have shorter surveys and a simpler recruitment process, use positive affect as the primary outcome and will not link to Google.com for the comparison arm. Trial registration number Australian New Zealand Clinical Trials Registry, ACTRN12614000386639. PMID:28694345

Prostate-Specific Antigen Persistence After Radical Prostatectomy as a Predictive Factor of Clinical Relapse-Free Survival and Overall Survival: 10-Year Data of the ARO 96-02 Trial

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

Wiegel, Thomas, E-mail: thomas.wiegel@uniklinik-ulm.de; Bartkowiak, Detlef; Bottke, Dirk

2015-02-01

Objective: The ARO 96-02 trial primarily compared wait-and-see (WS, arm A) with adjuvant radiation therapy (ART, arm B) in prostate cancer patients who achieved an undetectable prostate-specific antigen (PSA) after radical prostatectomy (RP). Here, we report the outcome with up to 12 years of follow-up of patients who retained a post-RP detectable PSA and received salvage radiation therapy (SRT, arm C). Methods and Materials: For the study, 388 patients with pT3-4pN0 prostate cancer with positive or negative surgical margins were recruited. After RP, 307 men achieved an undetectable PSA (arms A + B). In 78 patients the PSA remained above thresholds (median 0.6,more » range 0.05-5.6 ng/mL). Of the latter, 74 consented to receive 66 Gy to the prostate bed, and SRT was applied at a median of 86 days after RP. Clinical relapse-free survival, metastasis-free survival, and overall survival were determined by the Kaplan-Meier method. Results: Patients with persisting PSA after RP had higher preoperative PSA values, higher tumor stages, higher Gleason scores, and more positive surgical margins than did patients in arms A + B. For the 74 patients, the 10-year clinical relapse-free survival rate was 63%. Forty-three men had hormone therapy; 12 experienced distant metastases; 23 patients died. Compared with men who did achieve an undetectable PSA, the arm-C patients fared significantly worse, with a 10-year metastasis-free survival of 67% versus 83% and overall survival of 68% versus 84%, respectively. In Cox regression analysis, Gleason score ≥8 (hazard ratio [HR] 2.8), pT ≥ 3c (HR 2.4), and extraprostatic extension ≥2 mm (HR 3.6) were unfavorable risk factors of progression. Conclusions: A persisting PSA after prostatectomy seems to be an important prognosticator of clinical progression for pT3 tumors. It correlates with a higher rate of distant metastases and with worse overall survival. A larger prospective study is required to determine which patient subgroups will benefit most from which treatment option.« less

Visual Display of 5p-arm and 3p-arm miRNA Expression with a Mobile Application.

PubMed

Pan, Chao-Yu; Kuo, Wei-Ting; Chiu, Chien-Yuan; Lin, Wen-Chang

2017-01-01

MicroRNAs (miRNAs) play important roles in human cancers. In previous studies, we have demonstrated that both 5p-arm and 3p-arm of mature miRNAs could be expressed from the same precursor and we further interrogated the 5p-arm and 3p-arm miRNA expression with a comprehensive arm feature annotation list. To assist biologists to visualize the differential 5p-arm and 3p-arm miRNA expression patterns, we utilized a user-friendly mobile App to display. The Cancer Genome Atlas (TCGA) miRNA-Seq expression information. We have collected over 4,500 miRNA-Seq datasets from 15 TCGA cancer types and further processed them with the 5p-arm and 3p-arm annotation analysis pipeline. In order to be displayed with the RNA-Seq Viewer App, annotated 5p-arm and 3p-arm miRNA expression information and miRNA gene loci information were converted into SQLite tables. In this distinct application, for any given miRNA gene, 5p-arm miRNA is illustrated on the top of chromosome ideogram and 3p-arm miRNA is illustrated on the bottom of chromosome ideogram. Users can then easily interrogate the differentially 5p-arm/3p-arm expressed miRNAs with their mobile devices. This study demonstrates the feasibility and utility of RNA-Seq Viewer App in addition to mRNA-Seq data visualization.

Predictors of Study Attrition in a Randomized Controlled Trial Evaluating a Perinatal Home-Visiting Program with Mothers with Psychosocial Vulnerabilities

PubMed Central

Foulon, Stéphanie; Greacen, Tim; Pasquet, Blandine; Dugravier, Romain; Saïas, Thomas; Guedeney, Nicole; Guedeney, Antoine; Tubach, Florence

2015-01-01

Objective Randomised controlled trials evaluating perinatal home-visiting programs are frequently confronted with the problem of high attrition rates. The aim of the present study is to identify predictors of study attrition in a trial evaluating a perinatal home-visiting program in France. Materials and Methods CAPEDP is a French randomized trial comparing a perinatal home-visiting program using psychologists versus usual care (N = 440). The first assessment was at inclusion into the trial at the 27th week of pregnancy and the final assessment when the child reached the age of two. Attrition rates were calculated at 3 and 24 months postpartum. Stepwise logistic regression was used to identify predictors of early (between inclusion and 3 months postpartum) and later (between 3 and 24 months postpartum) attrition among social, psychological and parenting factors. Results Attrition rates were 17% and 63% at 3 and 24 months respectively. At 24 months, there was significantly more attrition in the control arm (70.6%) compared to the intervention arm (55.2%). Five independent predictors of early attrition were identified: having already had an abortion; having greater attachment insecurity as measured with the Vulnerable Attachment Style Questionnaire (VASQ); having lower global severity of psychiatric symptoms as assessed with the Symptom Check-List (SCL-90) at inclusion, being neither currently employed nor studying; and declaring no tobacco consumption during pregnancy. Being randomized into the control arm, having undergone early parental loss before age 11 and having lower global severity of psychiatric symptoms (SCL-90) at 3 months postpartum were the only variables associated with later attrition. Conclusion This study provides key information for identifying mothers who may require specific support to avoid study attrition in trials evaluating a home-visiting program. PMID:26554839

Comparative Evaluation of Topical 10% Potassium Hydroxide and 30% Trichloroacetic Acid in the Treatment of Plane Warts

PubMed Central

Jayaprasad, Sandhaya; Subramaniyan, Radhakrishnan; Devgan, Shalini

2016-01-01

Background: Warts are benign proliferations of skin and mucosa caused by the human papillomavirus (HPV). Plane warts are caused by HPV types 3, 10, 28, and 41, occurring mostly in children and young adults. Among the treatment modalities, topical application of trichloroacetic acid (TCA) is age old. Potassium hydroxide (KOH) has a keratolytic effect on virus-infected cells. It is less irritating, less painful, less scar forming, and can be safely used in children too. Hence, it could be a better topical agent in the treatment of plane warts. Aims and Objectives: To compare the safety and efficacy of topical 10% KOH with 30% TCA in the treatment of plane warts. Materials and Methods: Sixty consecutive patients with plane warts were randomly assigned into two arms of thirty patients each; arm A received topical 10% KOH and arm B received topical 30% TCA as a once weekly application until the complete clearance of warts or a maximum period of 12 weeks. Results: Statistically no significant difference (P = 0.07) was found between the objective therapeutic response to 10% KOH and 30% TCA at the end of study (12 weeks). However, subjective response to 10% KOH was better and statistically significant (P = 0.03). There was no recurrence of warts seen on follow-up for 3 months of complete responders in both the arms. Conclusion: 10% KOH is found to be equally effective in the treatment of plane warts compared to 30% TCA with the advantage of faster onset of action and tendency of completely clearing warts with fewer side effects. PMID:27904181

The effect of micronutrient supplementation on active TB incidence early in HIV infection in Botswana

PubMed Central

Campa, Adriana; Baum, Marianna K; Bussmann, Hermann; Martinez, Sabrina Sales; Farahani, Mansour; van Widenfelt, Erik; Moyo, Sikhulile; Makhema, Joseph; Essex, Max; Marlink, Richard

2017-01-01

Background Coinfection with active tuberculosis (TB) is one of the leading causes of death in people living with HIV (PLWH) in Africa. This investigation explores the role of micronutrient supplementation in preventing active TB in PLWH. Methods A randomized trial of nutritional supplementation was conducted among antiretroviral- naïve (without previous antiretroviral treatment [ART]) HIV-infected people in Botswana between 2004 and 2009. The study had a factorial design with four arms: the selenium (Se) alone arm, the multivitamins (MVT) alone arm that contained vitamin B complex and vitamins C and E, the combined Se+MVT group and the placebo group. Those participants with prior or current active TB were excluded, as were participants with advanced HIV disease (CD4 <250 cells/μL) or who had already qualified for ART. HIV-positive adults (N=878) were followed monthly for study pill dispensation, every 3 months for CD4 cell count and every 6 months for viral load during 24 months or until they were started on ART. Results The participants' characteristics were not significantly different among the four groups at baseline. Supplementation with Se alone (hazard ratio =0.20, 95% confidence interval: 0.04, 0.95, P=0.043) and the two combined SE groups (Se and Se+MVT) had significantly lower risk of developing incident TB disease compared with placebo in multivariate adjusted models (hazard ratio=0.32, 95% confidence interval: 0.11, 0.93, P=0.036). Multivitamins alone did not affect the incidence of TB. Isoniazid preventive therapy was received by 12.2% of participants, a rate that was not significantly different among the four study arms (P=0.122) and the newly diagnosed cases. Conclusion Se supplementation, alone and with MVT, decreased the incidence of TB disease in PLWH who were ART-naïve. Supplementation with these micronutrients should be considered in HIV infection, prior to ART, in areas where TB and malnutrition are endemic. PMID:29187783

The effects of intermittent vitamin D3 supplementation on muscle strength and metabolic parameters in postmenopausal women with type 2 diabetes: a randomized controlled study

PubMed Central

Cavalcante, Roseane; Maia, Juliana; Henrique, Rafael; Griz, Luiz; Bandeira, Maria P.; Bandeira, Francisco

2015-01-01

Background: The aim of this study was to evaluate the effect of weekly vitamin D3 supplementation on metabolic parameters and muscle strength of postmenopausal women with type 2 diabetes. Methods: A total of 38 patients with serum 25-hydroxy vitamin D [25(OH)D] below 30 ng/ml and hand strength below 20 kg were randomly assigned to oral vitamin D3 (6600 IU/week in 2 cc oil preparation) or 2 cc olive oil weekly for 3 months. Results: There were nonsignificant increases in serum 25(OH)D in the intervention group to 22.98 ± 4.23 ng/ml and nonsignificant decreases in the control group to 22.84 ± 3.88 (26% of the intervention and 48% of the control groups had 25(OH)D < 20 ng/ml). Handgrip strength improved significantly in the intervention group (right arm 17.4 ± 2.68 to 19.9 ± 3.53 kg, p = 0.002; left arm 16.31 ± 2.6 to 18.46 ± 3.2 kg, p < 0.001) but not in the control group (right arm 16.87 ± 3.99 to 17.93 ± 4.91 kg, p = 0.1; left arm 16.13 ± 4.29 to 16.86 ± 4.79 kg, p < 0.2). More patients in the control group became obese at the end of the study period (p = 0.014). There were no significant changes in mean fasting glucose, glycated haemoglobin (HbA1c), serum triglycerides and blood pressure with vitamin D supplementation. Systolic blood pressure increased significantly in the control group from 136.6 ± 18.6 to 141.4 ± 17.6 mmHg, p = 0.04). Conclusions: Vitamin D3 supplementation in doses equivalent to 942 IU/day improved isometric handgrip strength, but had no effect on glycaemic control in postmenopausal women with longstanding type 2 diabetes. PMID:26301064

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

PubMed

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

2017-11-01

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

5-Fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) plus sunitinib or bevacizumab as first-line treatment for metastatic colorectal cancer: a randomized Phase IIb study

PubMed Central

Hecht, J Randolph; Mitchell, Edith P; Yoshino, Takayuki; Welslau, Manfred; Lin, Xun; Chow Maneval, Edna; Paolini, Jolanda; Lechuga, Maria Jose; Kretzschmar, Albrecht

2015-01-01

Background Sunitinib is an oral inhibitor of tyrosine kinase receptors implicated in tumor proliferation, angiogenesis, and metastasis. In this randomized, multicenter, open-label Phase IIb study, sunitinib plus mFOLFOX6 (oxaliplatin plus leucovorin plus 5-fluorouracil) was compared with bevacizumab plus mFOLFOX6 as first-line therapy in patients with metastatic colorectal cancer. Methods Patients were stratified by performance status, baseline lactate dehydrogenase level, and prior adjuvant treatment, and randomized 1:1 to receive sunitinib 37.5 mg/day for 4 weeks on and 2 weeks off plus mFOLFOX6 every 2 weeks or bevacizumab 5 mg/kg every 2 weeks plus mFOLFOX6 every 2 weeks. The primary endpoint was progression-free survival. Secondary endpoints included objective response rate, overall survival, safety, and quality of life. Results Enrollment was closed early following accrual of 191 patients, based on an interim analysis showing an inferior trend in the primary progression-free survival efficacy endpoint for sunitinib. Ninety-six patients were randomized to sunitinib plus mFOLFOX6 and 95 to bevacizumab plus mFOLFOX6. Median progression-free survival was 9.3 months and 15.4 months, respectively, but the objective response rate was similar between the study arms. Median overall survival was 23.7 months and 34.1 months, respectively. Dose reductions and interruptions were more common with sunitinib. Hematologic toxicity was more common in the sunitinib arm. Conclusion While the results of the sunitinib arm are comparable with those of previously reported FOLFOX combinations, the sunitinib-based combination was associated with more toxicity than that observed with bevacizumab and mFOLFOX6. The bevacizumab arm had an unexpectedly good outcome, and was much better than that seen in the Phase III trials. Combination therapy with sunitinib plus mFOLFOX6 is not recommended for patients with metastatic colorectal cancer. PMID:26109878

Patterns of failure in patients with locally advanced head and neck cancer treated postoperatively with irradiation or concomitant irradiation with Mitomycin C and Bleomycin

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

Zakotnik, Branko; Budihna, Marjan; Smid, Lojze

2007-03-01

Purpose: The long term results and patterns of failure in patients with squamous cell head and neck carcinoma (SCHNC) treated in a prospective randomized trial in which concomitant postoperative radiochemotherapy with Mitomycin C and Bleomycin (CRT) was compared with radiotherapy only (RT), were analyzed. Patients and Methods: Between March 1997 and December 2001, 114 eligible patients with Stage III or IV SCHNC were randomized. Primary surgical treatment was performed with curative intent in all patients. Patients in both groups were postoperatively irradiated to the total dose of 56-70 Gy. Chemotherapy included Mitomycin C 15 mg/m{sup 2} after 10 Gy andmore » 5 mg of Bleomycin twice weekly during irradiation. Median follow-up was 76 months (48-103 months). Results: At 5 years in the RT and CRT arms, the locoregional control was 65% and 88% (p = 0.026), disease-free survival 33% and 53% (p = 0.035), and overall survival 37% and 55% (p = 0.091) respectively. Patients who benefited from chemotherapy were those with high-risk factors. The probability of distant metastases was 22% in RT and 20% in CRT arm (p = 0.913), of grade III or higher late toxicity 19% in RT and 26% in CRT arm (p = 0.52) and of thyroid dysfunction 36% in RT and 56% in CRT arm (p = 0.24). The probability to develop a second primary malignancy (SPM) was 34% in the RT and 8% in the CRT arm (p = 0.023). One third of deaths were due to infection, but there was no difference between the 2 groups. Conclusion: With concomitant radiochemotherapy, locoregional control and disease free survival were significantly improved. Second primary malignancies in the CRT arm compared to RT arm were significantly less frequent. The high probability of post treatment hypothyroidism in both arms warrants regular laboratory evaluation.« less

WE-EF-207-02: The Rotate-Plus-Shift C-Arm Trajectory: Theory and First Clinical Results

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

Ritschl, L; Kachelriess, M; Kuntz, J

Purpose: The proposed method enables the acquisition of a complete dataset for 3D reconstruction of C-Arm data using less than 180° rotation. Methods: Typically a C–arm cone–beam CT scan is performed using a circle–like trajectory around a region of interest. Therefore an angular range of at least 180° plus fan–angle must be covered to ensure a completely sampled data set. This fact defines some constraints on the geometry and technical specifications of a C–arm system, for example a larger C radius or a smaller C opening respectively. This is even more important for mobile C-arm devices which are typically usedmore » in surgical applications.To overcome these limitations we propose a new trajectory which requires only 180° minusfan–angle of rotation for a complete data set. The trajectory consists of three parts: A rotation of the C around a defined iso–center and two translational movements parallel to the detector plane at the begin and at the end of the rotation (rotate plus shift trajectory). This enables the acquisition of a completely sampled dataset using only 180° minus fan–angle of rotation. Results: For the evaluation of the method we show simulated and measured data. The results show, that the rotate plus shift scan yields equivalent image quality compared to the short scan which is assumed to be the gold standard for C-arm CT today. Compared to the pure rotational scan over only 165°, the rotate plus shift scan shows strong improvements in image quality. Conclusion: The proposed method makes 3D imaging using C–arms with less than 180° rotation range possible. This enables integrating full 3D functionality into a C- arm device without any loss of handling and usability for 2D imaging.« 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.

Post Hoc Analyses of ApoE Genotype-Defined Subgroups in Clinical Trials.

PubMed

Kennedy, Richard E; Cutter, Gary R; Wang, Guoqiao; Schneider, Lon S

2016-01-01

Many post hoc analyses of clinical trials in Alzheimer's disease (AD) and mild cognitive impairment (MCI) are in small Phase 2 trials. Subject heterogeneity may lead to statistically significant post hoc results that cannot be replicated in larger follow-up studies. We investigated the extent of this problem using simulation studies mimicking current trial methods with post hoc analyses based on ApoE4 carrier status. We used a meta-database of 24 studies, including 3,574 subjects with mild AD and 1,171 subjects with MCI/prodromal AD, to simulate clinical trial scenarios. Post hoc analyses examined if rates of progression on the Alzheimer's Disease Assessment Scale-cognitive (ADAS-cog) differed between ApoE4 carriers and non-carriers. Across studies, ApoE4 carriers were younger and had lower baseline scores, greater rates of progression, and greater variability on the ADAS-cog. Up to 18% of post hoc analyses for 18-month trials in AD showed greater rates of progression for ApoE4 non-carriers that were statistically significant but unlikely to be confirmed in follow-up studies. The frequency of erroneous conclusions dropped below 3% with trials of 100 subjects per arm. In MCI, rates of statistically significant differences with greater progression in ApoE4 non-carriers remained below 3% unless sample sizes were below 25 subjects per arm. Statistically significant differences for ApoE4 in post hoc analyses often reflect heterogeneity among small samples rather than true differential effect among ApoE4 subtypes. Such analyses must be viewed cautiously. ApoE genotype should be incorporated into the design stage to minimize erroneous conclusions.

[Neoadjuvant chemotherapy of osteosarcoma. Results of the cooperative studies COSS-80 and COSS-82 after 7 and 5 years].

PubMed

Bielack, S; Beck, J; Delling, G; Gerein, V; Grümayer, R; Hiddemann, W; Jobke, A; Jürgens, H; Kornhuber, G; Kotz, R

1989-01-01

The analysis of the results of two German Pediatric Oncology (GPO) cooperative, neoadjuvant chemotherapy trials after a followup of 7 (COSS-80) and 5 years (COSS-82) allows several conclusions concerning both systemic and local treatment of patients suffering from osteosarcoma. A metastasis free survival rate (MFS) of 59% was reached in the reduced study group of the first study, COSS-80. In addition to size of the primary tumor, the extent of chemotherapy induced devitalisation was very closely related to the probability of survival without systemic recurrence. Following this observation, it was the aim of the next study, COSS-82, to improve the MFS of patients with poorly responding tumors by altering their postoperative chemotherapy regimen. However, this "salvage" approach failed. Moreover, an effort to reduce treatment related toxicity by sparing some patients from the side effects of two particularly toxic drugs, adriamycin (ADR) and cisplatinum (CDDP), by only giving these postoperatively and only after insufficient tumor response to preoperative therapy, failed (MFS of the study arm of COSS-82 45% at 5 years vs. 68% for the control arm with primary use of ADR and CDDP, p less than 0.05). The value of an effective primary chemotherapy is further enhanced by the observation, that en bloc resection of tumors which were poor responders to preoperative therapy was associated with an increased risk of distant metastases when compared with amputation and rotation plasty, while this was not the case for good responders. In conclusion, both systemic tumor control and optimal local therapy require that all effects drugs are to be used as early as possible in the primary treatment of osteosarcoma, in order to enforce maximum tumor cell destruction and hence an optimistic outlook for the individual patient.

Physicians' perception of alternative displays of clinical research evidence for clinical decision support - A study with case vignettes.

PubMed

Slager, Stacey L; Weir, Charlene R; Kim, Heejun; Mostafa, Javed; Del Fiol, Guilherme

2017-07-01

To design alternate information displays that present summaries of clinical trial results to clinicians to support decision-making; and to compare the displays according to efficacy and acceptability. A 6-between (information display presentation order) by 3-within (display type) factorial design. Two alternate displays were designed based on Information Foraging theory: a narrative summary that reduces the content to a few sentences; and a table format that structures the display according to the PICO (Population, Intervention, Comparison, Outcome) framework. The designs were compared with the summary display format available in PubMed. Physicians were asked to review five clinical studies retrieved for a case vignette; and were presented with the three display formats. Participants were asked to rate their experience with each of the information displays according to a Likert scale questionnaire. Twenty physicians completed the study. Overall, participants rated the table display more highly than either the text summary or PubMed's summary format (5.9vs. 5.4vs. 3.9 on a scale between 1 [strongly disagree] and 7 [strongly agree]). Usefulness ratings of seven pieces of information, i.e. patient population, patient age range, sample size, study arm, primary outcome, results of primary outcome, and conclusion, were high (average across all items=4.71 on a 1 to 5 scale, with 1=not at all useful and 5=very useful). Study arm, primary outcome, and conclusion scored the highest (4.9, 4.85, and 4.85 respectively). Participants suggested additional details such as rate of adverse effects. The table format reduced physicians' perceived cognitive effort when quickly reviewing clinical trial information and was more favorably received by physicians than the narrative summary or PubMed's summary format display. Copyright © 2017 Elsevier Inc. All rights reserved.

Home-based interventions for black patients with uncontrolled hypertension: a cluster randomized controlled trial

PubMed Central

Feldman, Penny H; McDonald, Margaret V; Barrón, Yolanda; Gerber, Linda M; Peng, Timothy R

2016-01-01

Aim: Assess the comparative effectiveness of two blood pressure (BP) control interventions for black patients with uncontrolled hypertension. Patients & methods: A total of 845 patients were enrolled in a three-arm cluster randomized trial. On admission of an eligible patient, field nurses were randomized to usual care, a basic or augmented intervention. Results: Across study arms there were no significant 12 months differences in BP control rates (primary outcome) (25% usual care, 26% basic intervention, 22% augmented intervention); systolic BP (143.8 millimeters of mercury [mmHg], 146.9 mmHG, 143.9 mmHG, respectively); medication intensification (47, 43, 54%, respectively); or self-management score (18.7, 18.7, 17.9, respectively). Adjusted systolic BP dropped more than 10 mmHg from baseline to 12 months (155.5–145.4 mmHg) among all study participants. Conclusion: Neither the augmented nor basic intervention was more effective than usual care in improving BP control, systolic BP, medication intensification or patient self-management. Usual home care yielded substantial improvements, creating a high comparative effectiveness threshold. Clinical Trial Registration: NCT00139490. PMID:26946952

Assessment of contamination and misclassification biases in a randomized controlled trial of a social network peer education intervention to reduce HIV risk behaviors among drug users and risk partners in Philadelphia, PA and Chiang Mai, Thailand

PubMed Central

Simmons, Nicole; Donnell, Deborah; Ou, San-san; Celentano, David D.; Aramrattana, Apinun; Davis-Vogel, Annet; Metzger, David; Latkin, Carl

2015-01-01

Context Controlled trials of educational interventions are susceptible to contamination. Objectives To test a contamination measure based on recall of terms. Main study A randomized controlled trial of a social network peer education intervention among 1,123 injection drug users and risk partners in Philadelphia, PA and Chiang Mai, Thailand. Methods We assessed the recall of test, negative and positive control terms by intervention and control arm participants and compared the relative odds (OR) of recall of test vs. negative control terms between study arms. Results The contamination measure showed good discriminant ability only among participants from Chiang Mai. In Philadelphia there was no evidence of contamination and little evidence of diffusion. In Chiang Mai there was evidence of diffusion and contamination of 4 of 5 terms tested. Conclusions Network structure and peer education in Chiang Mai likely led to contamination. Recall of intervention materials can be a useful method to detect contamination in trials of educational interventions. PMID:25935214

The effects of additional arm weights on arm-swing magnitude and gait patterns in Parkinson's disease.

PubMed

Yoon, Jiyeon; Park, Jinse; Park, Kunbo; Jo, Geunyeol; Kim, Haeyu; Jang, Wooyoung; Kim, Ji Sun; Youn, Jinyoung; Oh, Eung Seok; Kim, Hee-Tae; Youm, Chang Hong

2016-01-01

Recently, arm facilitation has been interested in gait rehabilitation. However, there have been few studies concerning arm facilitation in patients with Parkinson's disease (PD). The aim of our study was to investigate the effect of increasing arm weights on gait pattern in patients with PD. Twenty-seven patients with PD were enrolled, and they underwent gait analysis using a three-dimensional motion capture system. Sandbags were applied to the distal forearms in all participants. We compared gait parameters including arm swing, pelvic motion, spatiotemporal data, and relative rotational angle between the weighted and unweighted gaits. The total arm-swing amplitude and pelvic rotation were significantly higher when walking with additional arm weights than without arm weights. Cadence, walking speed, stride length, and swing phase were significantly higher, whereas stride time, double-support time, and stance phase were significantly lower, when walking with additional arm weights than without arm weights. We conclude that adding weights to the arm during walking may facilitate arm and pelvic movements, which results in changes to gait patterns. The therapeutic use of additional arm weights could be considered for gait rehabilitation in PD to improve gait impairment. Arm-swing facilitation using weight load improved gait in Parkinson's disease. Copyright © 2015 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Passive or simulated displacement of one arm (but not its mirror reflection) modulates the involuntary motor behavior of the other arm.

PubMed

Brun, C; Metral, M; Chancel, M; Kavounoudias, A; Luyat, M; Guerraz, M

2015-01-29

Recent studies of both healthy and patient populations have cast doubt on the mirror paradigm's beneficial effect on motor behavior. Indeed, the voluntary arm displacement that accompanies reflection in the mirror may be the determining factor in terms of the motor behavior of the contralateral arm. The objective of the present study was to assess the respective effects of mirror reflection and arm displacement (whether real or simulated) on involuntary motor behavior of the contralateral arm following sustained, isometric contraction (Kohnstamm phenomenon). Our results revealed that (i) passive displacement of one arm (displacement of the left arm via a motorized manipulandum moving at 4°/s) influenced the velocity of the Kohnstamm phenomenon (forearm flexion occurring shortly after the cessation of muscle contraction) in the contralateral arm and (ii) mirror vision had no effect. Indeed, the velocity of the Kohnstamm phenomenon tended to be adjusted to match the velocity of the passive displacement of the other arm. In a second experiment, arm displacement was simulated by vibrating the triceps at 25, 50 or 75 Hz. Results showed that the velocity of the Kohnstamm phenomenon in one arm increased with the vibration frequency applied to the other arm. Our results revealed the occurrence of bimanual coupling because involuntary displacement of one arm was regulated by muscle-related information generated by the actual or simulated displacement of the other arm. In line with the literature data on voluntary motor behavior, our study failed to evidence an additional impact of mirror vision on involuntary motor behavior. Copyright © 2014 IBRO. Published by Elsevier Ltd. All rights reserved.

[Improvement of the system of medical equipmet rationing for military units during the wartime].

PubMed

Miroshnichenko, Iu V; Goriachev, A B; Popov, A A; Morgunov, V A; Ryzhikov, M V; Merkulov, A V

2013-07-01

The authors analyze new legal regulatory document--Medical equipment and reserves supply rate for military units and organisations of the Armed Forces of the Russian Federation, developed in the process of modernization of the system of medical equipment rationing for military units. New legal regulatory document was developed with the aim to replace the similar document d.d 1996-1997. The authors came to conclusion that costs of new medical equipment and reserves supply rates are similar to previous rates. At the same time costs new medical equipment supply rates for medical service increased more than 25%. It is related to change of the role of medical service in the system of medical supply of the Armed Forces of the Russian Federation. Modernization of the system of medical equipment supply rates for military unit of the Armed Forces of the Russian Federation, performed for the purpose of medical supplement for military unit in accordance with new state of the Armed Forces of the Russian Federation, allowed to actualize the regulatory framework of medical supply by means of development and adoption of new Supply and reserves rates be the Ministry of defence. Use if these rates will increase effectiveness and quality of medical supply during the wartime, provide a commonality of reserves of medical equipment and maintenance of established level of combat readiness of medical service of the Armed Forces of the Russian Federation.

Effects of anti-obesity drugs, diet, and exercise on weight-loss maintenance after a very-low-calorie diet or low-calorie diet: a systematic review and meta-analysis of randomized controlled trials123

PubMed Central

Neovius, Martin; Hemmingsson, Erik

2014-01-01

Background: Weight-loss maintenance remains a major challenge in obesity treatment. Objective: The objective was to evaluate the effects of anti-obesity drugs, diet, or exercise on weight-loss maintenance after an initial very-low-calorie diet (VLCD)/low-calorie diet (LCD) period (<1000 kcal/d). Design: We conducted a systematic review by using MEDLINE, the Cochrane Controlled Trial Register, and EMBASE from January 1981 to February 2013. We included randomized controlled trials that evaluated weight-loss maintenance strategies after a VLCD/LCD period. Two authors performed independent data extraction by using a predefined data template. All pooled analyses were based on random-effects models. Results: Twenty studies with a total of 27 intervention arms and 3017 participants were included with the following treatment categories: anti-obesity drugs (3 arms; n = 658), meal replacements (4 arms; n = 322), high-protein diets (6 arms; n = 865), dietary supplements (6 arms; n = 261), other diets (3 arms; n = 564), and exercise (5 arms; n = 347). During the VLCD/LCD period, the pooled mean weight change was −12.3 kg (median duration: 8 wk; range 3–16 wk). Compared with controls, anti-obesity drugs improved weight-loss maintenance by 3.5 kg [95% CI: 1.5, 5.5 kg; median duration: 18 mo (12–36 mo)], meal replacements by 3.9 kg [95% CI: 2.8, 5.0 kg; median duration: 12 mo (10–26 mo)], and high-protein diets by 1.5 kg [95% CI: 0.8, 2.1 kg; median duration: 5 mo (3–12 mo)]. Exercise [0.8 kg; 95% CI: −1.2, 2.8 kg; median duration: 10 mo (6–12 mo)] and dietary supplements [0.0 kg; 95% CI: −1.4, 1.4 kg; median duration: 3 mo (3–14 mo)] did not significantly improve weight-loss maintenance compared with control. Conclusion: Anti-obesity drugs, meal replacements, and high-protein diets were associated with improved weight-loss maintenance after a VLCD/LCD period, whereas no significant improvements were seen for dietary supplements and exercise. PMID:24172297

Physician step prescription and monitoring to improve ARTERial health (SMARTER): A randomized controlled trial in patients with type 2 diabetes and hypertension.

PubMed

Dasgupta, Kaberi; Rosenberg, Ellen; Joseph, Lawrence; Cooke, Alexandra B; Trudeau, Luc; Bacon, Simon L; Chan, Deborah; Sherman, Mark; Rabasa-Lhoret, Rémi; Daskalopoulou, Stella S

2017-05-01

There are few proven strategies to enhance physical activity and cardiometabolic profiles in patients with type 2 diabetes and hypertension. We examined the effects of physician-delivered step count prescriptions and monitoring. Participants randomized to the active arm were provided with pedometers and they recorded step counts. Over a 1-year period, their physicians reviewed their records and provided a written step count prescription at each clinic visit. The overall goal was a 3000 steps/day increase over 1 year (individualized rate of increase). Control arm participants were advised to engage in physical activity 30 to 60 min/day. We evaluated effects on step counts, carotid femoral pulse wave velocity (cfPWV, primary) and other cardiometabolic indicators including haemoglobin A1c in diabetes (henceforth abbreviated as A1c) and Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) in participants not receiving insulin therapy. A total of 79% completed final evaluations (275/347; mean age, 60 years; SD, 11). Over 66% of participants had type 2 diabetes and over 90% had hypertension. There was a net 20% increase in steps/day in active vs control arm participants (1190; 95% CI, 550-1840). Changes in cfPWV were inconclusive; active vs control arm participants with type 2 diabetes experienced a decrease in A1c (-0.38%; 95% CI, -0.69 to -0.06). HOMA-IR also declined in the active arm vs the control arm (ie, assessed in all participants not treated with insulin; -0.96; 95% CI, -1.72 to -0.21). A simple physician-delivered step count prescription strategy incorporated into routine clinical practice led to a net 20% increase in step counts; however, this was below the 3000 steps/day targeted increment. While conclusive effects on cfPWV were not observed, there were improvements in both A1c and insulin sensitivity. Future studies will evaluate an amplified intervention to increase impact. © 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Anti-PD-1 Blockade and Stereotactic Radiation Produce Long-Term Survival in Mice With Intracranial Gliomas

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

Zeng, Jing; See, Alfred P.; Phallen, Jillian

2013-06-01

Purpose: Glioblastoma multiforme (GBM) is the most common primary brain tumor in adults, and radiation is one of the main treatment modalities. However, cure rates remain low despite best available therapies. Immunotherapy is a promising modality that could work synergistically with radiation, which has been shown to increase antigen presentation and promote a proinflammatory tumor microenvironment. Programmed-death-1 (PD-1) is a surface receptor expressed on activated and exhausted T cells, which mediate T cell inhibition upon binding with its ligand PD-L1, expressed on many tumor types including human GBMs. We tested the combination of anti-PD-1 immunotherapy with stereotactic radiosurgery in amore » mouse orthotopic GBM model. Methods and Materials: We performed intracranial implantation of mouse glioma cell line GL261 transfected with luciferase into C57BL/6 mice. Mice were stratified into 4 treatment groups: (1) control; (2) radiation only; (3) anti-PD-1 antibody only; and (4) radiation plus anti-PD-1 antibody. Overall survival was quantified. The mice were killed on day 21 after implantation to assess immunologic parameters in the brain/tumor, cervical lymph nodes, and spleen. Results: Improved survival was demonstrated with combination anti-PD-1 therapy plus radiation compared with either modality alone: median survival was 25 days in the control arm, 27 days in the anti-PD-1 antibody arm, 28 days in the radiation arm, and 53 days in the radiation plus anti-PD-1 therapy arm (P<.05 by log-rank Mantle-Cox). Long-term survival was seen only in the combined treatment arm, with a fraction (15%-40%) of animals alive at day 180+ after treatment. Immunologic data on day 21 after implantation showed increased tumor infiltration by cytotoxic T cells (CD8+/interferon-γ+/tumor necrosis factor-α+) and decreased regulatory T cells (CD4+/FOXP3) in the combined treatment group compared with the single modality arms. Conclusions: The combination of PD-1 blockade and localized radiation therapy results in long-term survival in mice with orthotopic brain tumors. These studies provide strong preclinical evidence to support combination trials in patients with GBM.« less

Improving Breast Cancer Surgical Treatment Decision Making: The iCanDecide Randomized Clinical Trial.

PubMed

Hawley, Sarah T; Li, Yun; An, Lawrence C; Resnicow, Kenneth; Janz, Nancy K; Sabel, Michael S; Ward, Kevin C; Fagerlin, Angela; Morrow, Monica; Jagsi, Reshma; Hofer, Timothy P; Katz, Steven J

2018-03-01

Purpose This study was conducted to determine the effect of iCanDecide, an interactive and tailored breast cancer treatment decision tool, on the rate of high-quality patient decisions-both informed and values concordant-regarding locoregional breast cancer treatment and on patient appraisal of decision making. Methods We conducted a randomized clinical trial of newly diagnosed patients with early-stage breast cancer making locoregional treatment decisions. From 22 surgical practices, 537 patients were recruited and randomly assigned online to the iCanDecide interactive and tailored Web site (intervention) or the iCanDecide static Web site (control). Participants completed a baseline survey and were mailed a follow-up survey 4 to 5 weeks after enrollment to assess the primary outcome of a high-quality decision, which consisted of two components, high knowledge and values-concordant treatment, and secondary outcomes (decision preparation, deliberation, and subjective decision quality). Results Patients in the intervention arm had higher odds of making a high-quality decision than did those in the control arm (odds ratio, 2.00; 95% CI, 1.37 to 2.92; P = .0004), which was driven primarily by differences in the rates of high knowledge between groups. The majority of patients in both arms made values-concordant treatment decisions (78.6% in the intervention arm and 81.4% in the control arm). More patients in the intervention arm had high decision preparation (estimate, 0.18; 95% CI, 0.02 to 0.34; P = .027), but there were no significant differences in the other decision appraisal outcomes. The effect of the intervention was similar for women who were leaning strongly toward a treatment option at enrollment compared with those who were not. Conclusion The tailored and interactive iCanDecide Web site, which focused on knowledge building and values clarification, positively affected high-quality decisions largely by improving knowledge compared with static online information. To be effective, future patient-facing decision tools should be integrated into the clinical workflow to improve decision making.

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

PubMed Central

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

2013-01-01

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

Association of baseline absolute neutrophil counts and survival in patients with metastatic colorectal cancer treated with second-line antiangiogenic therapies: exploratory analyses of the RAISE trial and validation in an electronic medical record data set

PubMed Central

Grothey, Axel; Yoshino, Takayuki; Bodoky, Gyorgy; Ciuleanu, Tudor; Garcia-Carbonero, Rocio; García-Alfonso, Pilar; Van Cutsem, Eric; Muro, Kei; Mytelka, Daniel S; Li, Li; Lipkovich, Olga; Hsu, Yanzhi; Sashegyi, Andreas; Ferry, David; Nasroulah, Federico; Tabernero, Josep

2018-01-01

Background In the RAISE trial, ramucirumab+leucovorin/fluorouracil/irinotecan (FOLFIRI) improved the median overall survival (mOS) of patients with previously treated metastatic colorectal cancer versus patients treated with placebo+FOLFIRI but had a higher incidence of neutropaenia, leading to more chemotherapy dose modifications and discontinuations. Thus, we conducted an exploratory post-hoc analysis of RAISE and a retrospective, observational analysis of electronic medical record (EMR) data to determine and verify the association of neutropaenia, baseline absolute neutrophil count (ANC) and survival. Methods The RAISE analysis used the study safety population (n=1057). IMS Health Oncology Database (IMS EMR) was the source for the real-world data set (n=617). Results RAISE patients with treatment-emergent neutropaenia had improved mOS compared with those without (ramucirumab arm: 16.1 vs 10.7 months, HR=0.57, p<0.0001; placebo arm: 12.7 vs 10.7 months, HR=0.76, p=0.0065). RAISE patients with low ANC versus high baseline ANC also had longer mOS (ramucirumab arm: 15.2 vs 8.9 months, HR=0.49, p<0.0001; placebo arm: 13.2 vs 7.3 months, HR=0.50, p<0.0001). The results were similar for IMS EMR low versus high baseline ANC (bevacizumab+FOLFIRI patients: 14.9 vs 7.7 months, HR=0.59, p<0.0001; FOLFIRI alone: 14.6 vs 5.4 months, HR=0.37, p<0.0001). Patients in the RAISE trial with low baseline ANC were more likely to develop neutropaenia (OR: ramucirumab arm=2.62, p<0.0001; placebo arm=2.16, p=0.0003). Conclusion Neutropaenia during treatment, and subsequent dose modifications or discontinuations, do not compromise treatment efficacy. Baseline ANC is a strong prognostic factor for survival and is associated with treatment-emergent neutropaenia in the analysed population. Trial registration number NCT01183780, Results. PMID:29713498

Role of Surgical Versus Clinical Staging in Chemoradiated FIGO Stage IIB-IVA Cervical Cancer Patients—Acute Toxicity and Treatment Quality of the Uterus-11 Multicenter Phase III Intergroup Trial of the German Radiation Oncology Group and the Gynecologic Cancer Group

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

Marnitz, Simone, E-mail: simone.marnitz-schulze@uk-koeln.de; Martus, Peter; Köhler, Christhardt

Purpose: The Uterus-11 trial was designed to evaluate the role of surgical staging in patients with cervical cancer before primary chemoradiation therapy (CRT). The present report provides the toxicity data stratified by the treatment arm and technique. Methods and Materials: A total of 255 patients with carcinoma of the uterine cervix (International Federation of Gynecology and Obstetrics stage IIB-IVA) were randomized to either surgical staging followed by CRT (arm A) or clinical staging followed by CRT (arm B). Patients with para-aortic metastases underwent extended field radiation therapy (RT). Brachytherapy was mandatory. The present report presents the acute therapy-related toxicities stratifiedmore » by treatment arm and radiation technique. Results: A total of 240 patients were eligible (n=121 in arm A; n=119 in arm B). Of the 240 patients, 236 (98.3%) underwent external beam RT with a median total dose of 50.4 Gy. The mean treatment duration was 53 days. Of the patients, 60% underwent intensity modulated RT (IMRT). A total of 234 patients (97.5%) underwent chemotherapy, and 231 (96.3%) underwent brachytherapy, with a median single dose of 6 Gy covering the tumor to a median nominal total dose of 28 Gy. Treatment was well tolerated, with 0% grade ≥3 genitourinary and gastrointestinal toxicity, 6% grade 3 nausea, 3% grade 3 vomiting, and <2% grade 3 diarrhea. More patients after surgical staging experienced grade 2 anemia (54.3% in arm A vs 45.3% in arm B; P=.074) and grade 2 leukocytopenia (41.4% vs 31.6%; P=.56). Of the patients who received IMRT versus a 3-dimensional technique, 65.3% versus 33.7% presented with grade 2 anemia. Grade 3 gastrointestinal and grade 2 bladder toxicity were significantly reduced with the use of IMRT. Conclusions: The incidence and severity of acute therapy-related toxicity compared favorably with those from other randomized trials. Excellent adherence to treatment and treatment quality was achieved compared with patterns of care analyses. Surgical staging led to a doubled number of patients treated with extended field RT. The question of whether surgical staging is beneficial in the context of primary CRT requires further study.« less

SU-E-T-209: Comparison of Plan Quality Between Arm Avoidance (AA) Vs. Non Arm Avoidance VMAT Planning Techniques for Breast Cancer Patients with Bilateral Implant Reconstructions Receiving Postmastectomy Radiation

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

Kuo, L; Ballangrud, A; Ho, A

Purpose: Breast cancer patients with bilateral implant reconstructions who require postmastectomy radiotherapy can pose unique treatment planning challenges. The use of VMAT may provide advantages over conventional tangent or multi-beam IMRT techniques. Moreover, daily setup uncertainly of the arm position, however, could have significant impact on accurate dose delivery. This study compares the plan qualities between non-AA and AA VMAT techniques. Methods: Three breast cancer patients receiving left chest wall and regional nodal irradiation with bilateral implant reconstructions were studied. PTV included chest wall and IMNs (PTV-CW), and supraclavicular and axillary lymph nodes (PTV-SCV). For each patient, one non-AA VMATmore » plan (VMAT-S) with 4 partial arcs encompassing the ipsilateral arm and three AA VMAT plans where no arcs were entering or existing through the ipsilateral arm were generated. VMAT-AA1 uses 2 arcs for PTV-CW and 2 arcs for PTV-SCV. VMAT-AA2 used two static fields for PTV-SCV with 2 arcs for PTV-CW. VMAT-AA3 used 2 narrow arcs for PTV-CW and 2 long arcs for all PTVs. Prescription dose (PD) was 50 Gy (25 fractions). All plans were normalized to have 95% of PD to 95 % of PTV. PTV dose inhomogeneity and dose to the heart, left lung, right thyroid dose and left humerus were evaluated. Results: For VMAT-S, VMAT-AA1, VMAT-AA2 and VMAT-AA3, respectively, the average and standard deviation (in Gy unless specified otherwise) of PTV D05 are 54.7±0.9, 55.9±0.4, 56.7±0.7 and 55.7±0.4; mean Heart dose: 7.1±0.7, 7.2±0.8, 7.3±0.9 and 6.9±1.0; left lung V20Gy (in %): 28.1±1.0, 28.8+2.2, 32.2±4.1 and 27.8±2.0; mean right thyroid dose: 8.1±0.6, 5.1±2.1, 2.1±0.4 and 5.0±2.0; mean left humerus dose: 20.0±4.4,15.6±4.4, 15.2±8.2 and 15.3±4.6. Conclusion: AA VMAT can produce acceptable clinical plans while eliminating dosimetric impact related to arm setup uncertainty. These data require validation in larger planning studies prior to routine clinical implantation.« less

Prefrontal Cortical GABA Modulation of Spatial Reference and Working Memory

PubMed Central

Auger, Meagan L.

2015-01-01

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

Innovative approaches to the rehabilitation of upper extremity hemiparesis using virtual environments

PubMed Central

MERIANS, A. S.; TUNIK, E.; FLUET, G. G.; QIU, Q.; ADAMOVICH, S. V.

2017-01-01

Aim Upper-extremity interventions for hemiparesis are a challenging aspect of stroke rehabilitation. Purpose of this paper is to report the feasibility of using virtual environments (VEs) in combination with robotics to assist recovery of hand-arm function and to present preliminary data demonstrating the potential of using sensory manipulations in VE to drive activation in targeted neural regions. Methods We trained 8 subjects for 8 three hour sessions using a library of complex VE’s integrated with robots, comparing training arm and hand separately to training arm and hand together. Instrumented gloves and hand exoskeleton were used for hand tracking and haptic effects. Haptic Master robotic arm was used for arm tracking and generating three-dimensional haptic VEs. To investigate the use of manipulations in VE to drive neural activations, we created a “virtual mirror” that subjects used while performing a unimanual task. Cortical activation was measured with functional MRI (fMRI) and transcranial magnetic stimulation. Results Both groups showed improvement in kinematics and measures of real-world function. The group trained using their arm and hand together showed greater improvement. In a stroke subject, fMRI data suggested virtual mirror feedback could activate the sensorimotor cortex contralateral to the reflected hand (ipsilateral to the moving hand) thus recruiting the lesioned hemisphere. Conclusion Gaming simulations interfaced with robotic devices provide a training medium that can modify movement patterns. In addition to showing that our VE therapies can optimize behavioral performance, we show preliminary evidence to support the potential of using specific sensory manipulations to selectively recruit targeted neural circuits. PMID:19158659

[Clinical application of three-dimensional O-arm navigation system in treating patients with dystrophic scoliosis secondary to neurofibromatosis type Ⅰ].

PubMed

Liu, Z; Qiu, Y; Li, Y; Zhao, Z H; Wang, B; Zhu, F; Yu, Y; Sun, X; Zhu, Z Z

2017-03-01

Objective: To investigate the clinical outcomes and the accuracy of O-arm-navigation system assisted pedicle screw insertion in dystrophic scoliosis secondary to neurofibromatosis type Ⅰ(NF-1). Methods: A retrospective study was conducted in 41 patients with dystrophic NF-1-associated thoracic scoliosis who were surgically treated at Department of Orthopaedics, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School between June 2012 and October 2014 with more than 18 months follow-up. The patients were then divided into two groups: 18 patients were under the assistance of O-arm-navigation-based pedicle screw insertion (O-arm group) and the remaining 23 patients' pedicle screws insertion were conducted by free-hand (free-hand group). The X-ray and CT were analyzed to investigate the correction rate and safety of pedicle insertion. t -test was used to analyze measurement data and χ(2) test was used to analyze accuracy of screw insertion between the two groups. Results: The mean coronal Cobb angle was 63.2°±8.7° in the O-arm group and 66.9°±7.4° in the free-hand group ( P >0.05), which was then corrected into 23.1°±6.8° and 30.2°±7.6°( t =2.231, P =0.031) after surgery respectively.Operation time was (265.0±70.3)minutes and estimated blood loss was (1 024±465)ml in the O-arm group. Operation time and estimated blood loss was (243.0±49.6)minutes and (1 228±521)ml respectively in the free-hand group, which had no significant difference between the two groups. However, the implant density was higher in the O-arm group than that in the free-hand group ((64.1±10.8)% vs .(44.3±15.3)%)( t =4.652, P =0.000). The O-arm group comprised 122 screws, of which 72.9% were excellent, 22.1% were good and 4.9% were bad. The free-hand group comprised 136 screws and 48.5% of them were excellent, 33.8% were good and 17.6% were bad.Accuracy of pedicle screw insertion was higher in the O-arm group than that in the free-hand group(χ(2)=10.140, P <0.05). By June 2016, the average follow-up period was (20.9±3.4)months(ranging from18 to 26 months), including (20.3±3.1)months in the O-arm group and (21.4±5.5)months in the free-hand group. At last follow-up point, coronal correction loss was significantly higher in the free-hand group than that in the O-arm group (6.3°±2.6° vs . 4.4°±1.6°)( t =2.719, P =0.009). Conclusions: Compared with free-hand technique, O-arm-navigation technique could enhance accuracy of pedicle insertion and implant density of dystrophic region in dystrophic NF-1-associated scoliosis patients, which result in a better correction rate and less correction loss. Besides, the advantage of O-arm-navigation do not increase operative time and estimate blood loss.

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

PubMed Central

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

2013-01-01

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

The effect of neonatal N-methyl-D-aspartate receptor blockade on exploratory and anxiety-like behaviors in adult BALB/c and C57BL/6 mice.

PubMed

Akillioglu, Kubra; Binokay, Secil; Kocahan, Sayad

2012-07-15

N-methyl-D-aspartate (NMDA) receptors play an important role in brain maturation and developmental processes. In our study, we evaluated the effects of neonatal NMDA receptor blockade on exploratory locomotion and anxiety-like behaviors of adult BALB/c and C57BL/6 mice. In this study, NMDA receptor hypofunction was induced 7-10 days after birth using MK-801 in BALB/c and C57BL/6 mice (0.25mg/kg twice a day for 4 days via intraperitoneal injection). The open-field (OF) and elevated plus maze (EPM) tests were used to evaluate exploratory locomotion and anxiety-like behaviors. In the OF, BALB/c mice spent less time in the center of the field (p<0.05) and had less vertical locomotor activity (p<0.01) compared to C57BL/6 mice. In BALB/c mice, MK-801 caused a decrease in vertical and horizontal locomotor activity in the OF test, compared to the control group (p<0.05). In C57BL/6 mice, MK-801 treatment increased horizontal locomotor activity and decreased time spent in the center in the OF test (p<0.05). In the EPM, the number of open-arm entries, the percentage of open-arm time (p<0.01) and total arm entries (p<0.05) were lower in BALB/c mice compared to C57BL/6 mice. In BALB/c mice, MK-801 caused an increase in the percentage of open-arm time compared to the control group (p<0.05). In C57BL/6 mice, MK-801 caused a decrease in the percentage of open-arm time compared to the control group (p<0.05). MK-801 decreased exploratory and anxiety-like behaviors in BALB/c mice. In contrast, MK-801 increased exploratory and anxiety-like behaviors in C57BL/6 mice. In conclusion, hereditary factors may play an important role in neonatal NMDA receptor blockade-induced responses. Copyright © 2012 Elsevier B.V. All rights reserved.

Is It Important to Adapt Neoadjuvant Chemotherapy to the Visible Clinical Response? An Open Randomized Phase II Study Comparing Response-Guided and Standard Treatments in HER2-Negative Operable Breast Cancer

PubMed Central

Mouret-Reynier, Marie-Ange; Savoye, Aude-Marie; Abrial, Catherine; Kwiatkowski, Fabrice; Garbar, Christian; DuBray-Longeras, Pascale; Eymard, Jean-Christophe; Lebouedec, Guillaume; Vanpraagh, Isabelle; Penault-Llorca, Frederique; Chollet, Philippe; Cure, Hervé

2015-01-01

Background. Neoadjuvant treatment provides a unique opportunity to evaluate individual tumor sensitivity. This study evaluated whether a response-guided strategy could improve clinical outcome compared with a standard treatment. Methods. Overall, 264 previously untreated stage II–III operable breast cancer patients were randomized to receive either standard treatment (arm A, n = 131), consisting of fluorouracil, epirubicin, and cyclophosphamide (FEC100: 500, 100, and 500 mg/m2, respectively, for 3 cycles) followed by docetaxel (100 mg/m2 for 3 cycles), or adapted treatment (arm B, n = 133), beginning with 2 cycles of FEC100 and switching to docetaxel if tumor size decreased by <30% after 2 cycles or <50% after 4 cycles of FEC100 (ultrasound assessments according to World Health Organization criteria). Otherwise, FEC100 was given for six cycles before surgery. Intent-to-treat analysis was performed. Results. Similar results were observed for clinical response (objective response was 54% vs 56%, p = .18), breast conservation surgery (BCS; 67% vs 68%, p = .97), and pathological complete response rate (Chevallier classification: 14% vs 11%, p = .68; Statloff classification: 16% vs 13%, p = .82) between arms A and B. Similar toxicities were observed, even with unbalanced numbers of FEC100 and docetaxel courses. Conclusion. Adapted and standard treatments had similar results in terms of tumor response, BCS rate, and tolerability. Further survival outcome data are expected. PMID:25637380

Effects of Periodontal Therapy on Rate of Preterm Delivery A Randomized Controlled Trial

PubMed Central

Offenbacher, Steven; Beck, James D.; Jared, Heather L.; Mauriello, Sally M.; Mendoza, Luisto C.; Couper, David J.; Stewart, Dawn D.; Murtha, Amy P.; Cochran, David L.; Dudley, Donald J.; Reddy, Michael S.; Geurs, Nicolaas C.; Hauth, John C.

2010-01-01

OBJECTIVE To test the effects of maternal periodontal disease treatment on the incidence of preterm birth (delivery before 37 weeks of gestation). METHODS The Maternal Oral Therapy to Reduce Obstetric Risk Study was a randomized, treatment-masked, controlled clinical trial of pregnant women with periodontal disease who were receiving standard obstetric care. Participants were assigned to either a periodontal treatment arm, consisting of scaling and root planing early in the second trimester, or a delayed treatment arm that provided periodontal care after delivery. Pregnancy and maternal periodontal status were followed to delivery and neonatal outcomes until discharge. The primary outcome (gestational age less than 37 weeks) and the secondary outcome (gestational age less than 35 weeks) were analyzed using a χ2 test of equality of two proportions. RESULTS The study randomized 1,806 patients at three performance sites and completed 1,760 evaluable patients. At baseline, there were no differences comparing the treatment and control arms for any of the periodontal or obstetric measures. The rate of preterm delivery for the treatment group was 13.1% and 11.5% for the control group (P=.316). There were no significant differences when comparing women in the treatment group with those in the control group with regard to the adverse event rate or the major obstetric and neonatal outcomes. CONCLUSION Periodontal therapy did not reduce the incidence of preterm delivery. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, www.clinicaltrials.gov, NCT00097656. LEVEL OF EVIDENCE I PMID:19701034

An ergonomic intervention to reduce musculoskeletal discomfort among semiconductor assembly workers.

PubMed

Aghilinejad, Mashallah; Azar, Neda Soleimanvandy; Ghasemi, Mohammad Sadegh; Dehghan, Naser; Mokamelkhah, Elahe Kabir

2016-06-14

Work-related musculoskeletal disorders (MSDs) and ergonomics-related injuries are the single largest category of workplace injuries and are responsible for almost 30% of all worker's compensation costs. Awkward working posture refers to positions of the body that deviate significantly from the neutral position while job tasks are being performed and it is the primary ergonomic risk factor for developing musculoskeletal discomfort. This study was conducted among assembly workers of a semiconductor in Tehran province with the objective of implementing an interventional ergonomic program to minimize musculoskeletal discomfort. This study that was conducted on 105 male assembly workers of a semiconductor industry based on a census method. The standardized Nordic Musculoskeletal Questionnaire (NMQ) was used to determine the prevalence of MSDs. Corlett and Bishop's body part discomfort scale (BPD) was applied to evaluate body discomfort before and after the intervention (using a magnifying loupes to improve visibility of the parts). The results of NMQ showed the highest rate of MSDs were in neck, shoulder, upper arm and lower back regions (more than 75%). After ergonomic intervention, significant decrements of discomfort was observed in neck, shoulder, upper arm, elbows, lower arm, lower back and whole body discomfort (p < 0.05). It can be concluded that using magnifying loupes reduced discomfort in different body regions and the whole body. A conclusion of this research is that ergonomic interventions can decrease MSDs of at risk body regions in the long term.

Prospective, Multi-Centre, Single-Arm Study of Mechanical Thrombectomy using Solitaire FR in Acute Ischemic Stroke-STAR

PubMed Central

Pereira, Vitor M; Gralla, Jan; Davalos, Antoni; Bonafé, Alain; Castaño, Carlos; Chapot, Rene; Liebeskind, David S; Nogueira, Raul G; Arnold, Marcel; Sztajzel, Roman; Liebig, Thomas; Goyal, Mayank; Besselmann, Michael; Moreno, Alfredo; Schroth, Gerhard

2013-01-01

Background and Purpose Mechanical thrombectomy using stent retriever devices have been advocated to increase revascularization in intracranial vessel occlusion. We present the results of a large prospective study on the use of the Solitaire FR in patients with acute ischemic stroke. Methods STAR was an international, multicenter, prospective, single-arm study of Solitaire FR thrombectomy in patients with large vessel anterior circulation strokes treated within 8 hours of symptom onset. Strict criteria for site selection were applied. The primary endpoint was the revascularization rate (3TICI 2b) of the occluded vessel as determined by an independent core lab. The secondary endpoint was the rate of good functional outcome (defined as 90-day modified Rankin scale (mRS) 0–2). Results A total of 202 patients were enrolled across 14 comprehensive stroke centers in Europe, Canada and Australia. The median age was 72 years, 60% were female patients. The median National Institute of Health Stroke Scale (NIHSS) was 17. Most proximal intracranial occlusion was the internal carotid artery in 18%, the middle cerebral artery in 82%. Successful revascularization was achieved in 79.2% of patients. Device and/or procedure related severe adverse events were found in 7.4%. Favorable neurological outcome was found in 57.9%. The mortality rate was 6.9%. Any intracranial hemorrhagic transformation was found in 18.8% of patients, 1.5% were symptomatic. Conclusions In this single arm study, treatment with the Solitaire™ FR device in intracranial anterior circulation occlusions results in high rates of revascularization, low risk of clinically relevant procedural complications, and good clinical outcomes in combination with low mortality at 90 days. Clinical Trial Registration This study is registered with ClinicalTrials.gov, number NCT01327989. PMID:23908066

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

PubMed Central

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

2013-01-01

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

Phase III Noninferiority Trial Comparing Irinotecan With Oxaliplatin, Fluorouracil, and Leucovorin in Patients With Advanced Colorectal Carcinoma Previously Treated With Fluorouracil: N9841

PubMed Central

Kim, George P.; Sargent, Daniel J.; Mahoney, Michelle R.; Rowland, Kendrith M.; Philip, Philip A.; Mitchell, Edith; Mathews, Abraham P.; Fitch, Tom R.; Goldberg, Richard M.; Alberts, Steven R.; Pitot, Henry C.

2009-01-01

Purpose The primary goal of this multicenter phase III trial was to determine whether overall survival (OS) of fluorouracil (FU) -refractory patients was noninferior when treated with second-line infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4; arm B) versus irinotecan (arm A). Cross-over to the other treatment on disease progression was mandated. Patients and Methods Patients who experienced treatment failure with one prior FU-based therapy and had not received prior irinotecan or oxaliplatin, either for metastatic disease or within 6 months of adjuvant FU therapy, were randomly assigned to arm A (irinotecan 350 or 300 mg/m2 every 3 weeks) or arm B (FOLFOX4). Results A total of 491 patients were randomly assigned (arm A, n = 245; arm B, n = 246); 288 (59%) had experienced treatment failure with FU for metastatic colorectal cancer. Two hundred twenty-seven patients (46%) received protocol-mandated third-line therapy (arm A, 43%; arm B, 57%). Median survival was 13.8 months (95% CI, 12.2 to 15.0 months) for initial treatment with FOLFOX4 and 14.3 months (95% CI, 12.0 to 15.9 months) for irinotecan (P = .38; hazard ratio = 0.92; 95% CI, 0.8 to 1.1). Response rates (RR; 28% v 15.5%; P = .0009) and time to progression (TTP; 6.2 v 4.4 months; P = .0009) were significantly superior with FOLFOX4. In the nonrandom subset of patients who crossed over, RR and TTP improvements with FOLFOX4 continued into third-line treatment. Irinotecan therapy was associated with more grade 3 nausea, vomiting, diarrhea, and febrile neutropenia; FOLFOX4 was associated with more neutropenia and paresthesias. Conclusion In patients who experienced treatment failure with front-line FU therapy, OS does not significantly differ whether second-line therapy begins with irinotecan or FOLFOX4. FOLFOX4 produces higher RR and longer TTP. Both arms had notable OS in patients who experienced treatment failure with first-line FU therapy. PMID:19380443

Modulation of corticospinal input to the legs by arm and leg cycling in people with incomplete spinal cord injury.

PubMed

Zhou, R; Alvarado, L; Kim, S; Chong, S L; Mushahwar, V K

2017-10-01

The spinal cervico-lumbar interaction during rhythmic movements in humans has recently been studied; however, the role of arm movements in modulating the corticospinal drive to the legs is not well understood. The goals of this study were to investigate the effect of active rhythmic arm movements on the corticospinal drive to the legs ( study 1 ) and assess the effect of simultaneous arm and leg training on the corticospinal pathway after incomplete spinal cord injury (iSCI) ( study 2). In study 1 , neurologically intact (NI) participants or participants with iSCI performed combinations of stationary and rhythmic cycling of the arms and legs while motor evoked potentials (MEPs) were recorded from the vastus lateralis (VL) muscle. In the NI group, arm cycling alone could facilitate the VL MEP amplitude, suggesting that dynamic arm movements strongly modulate the corticospinal pathway to the legs. No significant difference in VL MEP between conditions was found in participants with iSCI. In study 2 , participants with iSCI underwent 12 wk of electrical stimulation-assisted cycling training: one group performed simultaneous arm and leg (A&L) cycling and the other legs-only cycling. MEPs in the tibialis anterior (TA) muscle were compared before and after training. After training, only the A&L group had a significantly larger TA MEP, suggesting increased excitability in the corticospinal pathway. The findings demonstrate the importance of arm movements in modulating the corticospinal drive to the legs and suggest that active engagement of the arms in lower limb rehabilitation may produce better neural regulation and restoration of function. NEW & NOTEWORTHY This study aimed to demonstrate the importance of arm movements in modulating the corticospinal drive to the legs. It provides direct evidence in humans that active movement of the arms could facilitate corticospinal transmission to the legs and, for the first time, shows that facilitation is absent after spinal cord injury. Active engagement of the arms in lower limb rehabilitation increased the excitability of the corticospinal pathway and may produce more effective improvement in leg function. Copyright © 2017 the American Physiological Society.

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

PubMed

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

2006-12-01

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

A structural comparison of female-male and female-female mounting in Japanese macaques (Macaca fuscata).

PubMed

Ottenheimer Carrier, Lydia; Leca, Jean-Baptiste; Pellis, Sergio; Vasey, Paul L

2015-10-01

In certain populations, female Japanese macaques (Macaca fuscata) mount both males and females. Vasey (2007) proposed that female-female sexual mounting in Japanese macaques may be a neutral evolutionary by-product of a purported adaptation, namely, female-male mounting. In this study, we aim to further examine the proposed link between female-male and female-female mounting in Japanese macaques by comparing the structural characteristics that define both forms of mounting. We do so using Eshkol-Wachman Movement Notation (EWMN), a globographic reference system that can be used to describe the position of body segments. No significant differences were observed in the female mounters' positioning of eight different body segments (i.e., lower torso, mid-torso, upper torso, upper arm, lower arm, upper leg, lower leg, and foot) during female-male and female-female mounting. This finding lends support to the conclusion that female-female and female-male mounting are structurally, and thus, evolutionarily, related. Copyright © 2015 Elsevier B.V. All rights reserved.

'Pharyngocise': Randomized Controlled Trial of Preventative Exercises to Maintain Muscle Structure and Swallowing Function During Head-and-Neck Chemoradiotherapy

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

Carnaby-Mann, Giselle, E-mail: gmann@phhp.ufl.edu; Crary, Michael A.; Schmalfuss, Ilona

2012-05-01

Purpose: Dysphagia after chemoradiotherapy is common. The present randomized clinical trial studied the effectiveness of preventative behavioral intervention for dysphagia compared with the 'usual care.' Methods and Materials: A total of 58 head-and-neck cancer patients treated with chemoradiotherapy were randomly assigned to usual care, sham swallowing intervention, or active swallowing exercises (pharyngocise). The intervention arms were treated daily during chemoradiotherapy. The primary outcome measure was muscle size and composition (determined by T{sub 2}-weighted magnetic resonance imaging). The secondary outcomes included functional swallowing ability, dietary intake, chemosensory function, salivation, nutritional status, and the occurrence of dysphagia-related complications. Results: The swallowing musculaturemore » (genioglossus, hyoglossuss, and mylohyoid) demonstrated less structural deterioration in the active treatment arm. The functional swallowing, mouth opening, chemosensory acuity, and salivation rate deteriorated less in the pharyngocise group. Conclusion: Patients completing a program of swallowing exercises during cancer treatment demonstrated superior muscle maintenance and functional swallowing ability.« less

Hydrokinesitherapy program using the Halliwick method on strength endurance and flexibility in a person with poliomyelitis sequelae.

PubMed

Ochoa Martínez, Paulina Yesica; Hall Lopez, Javier Arturo; Mateos Valenzuela, Adriana Griselda

2014-09-12

This case study attempts to determine the effect of a hydrokinesitherapy program by means of the Halliwick method on physical fitness in a female aged 35 years with poliomyelitis sequelae. The intervention followed sixteen weeks of hydrokinesitherapy during 70 minutes, five times a week, where we carried out exercises from the Halliwick method. There was an assessment both before and after the application. Strength endurance and flexibility were determined according to a senior fitness test protocol. The results showed positive improvements when carrying out the exercises from the Halliwick method and the percentage change (Δ%) of strength endurance increase 361.5% in the right arm and 300% in the left arm. Flexibility increased 2 cm in the right shoulder and 10 cm in the left shoulder. In conclusion the subject was able to improve the performance of Halliwick exercises while showing an increase in strength endurance and flexibility. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

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

Randomized Phase II Trial Evaluating Two Paclitaxel and Cisplatin–Containing Chemoradiation Regimens As Adjuvant Therapy in Resected Gastric Cancer (RTOG-0114)

PubMed Central

Schwartz, Gary K.; Winter, Kathryn; Minsky, Bruce D.; Crane, Christopher; Thomson, P. John; Anne, Pramila; Gross, Howard; Willett, Christopher; Kelsen, David

2009-01-01

Purpose The investigational arm of INT0116, a fluorouracil (FU) and leucovorin–containing chemoradiotherapy regimen, is a standard treatment for patients with resected gastric cancer with a 2-year disease-free survival rate (DFS) of 52%. Toxicity is also significant. More beneficial and safer regimens are needed. Patients and Methods We performed a randomized phase II study among 39 cancer centers to evaluate two paclitaxel and cisplatin–containing regimens, one with FU (PCF) and the other without (PC) in patients with resected gastric cancer. Patients received two cycles of postoperative chemotherapy followed by 45 Gy of radiation with either concurrent FU and paclitaxel or paclitaxel and cisplatin. The primary objective was to show an improvement in 2-year DFS to 67% as compared with INT 0116. Results From May 2001 to February 2004 (study closure), 78 patients entered this study, and 73 were evaluable. At the planned interim analysis of 22 patients on PCF, grade 3 or higher GI toxicity was 59%. This was significantly worse than INT0116, and this arm was closed. Accrual continued on PC. The median DFS was 14.6 months for PCF and has not been reached for PC. For PC the 2-year DFS is 52% (95% CI, 36% to 68%). Conclusion Though PC appears to be safe and the median DFS favorable, the DFS failed to exceed the lower bound of 52.9% for the targeted 67% DFS at 2 years and can not be recommended as the adjuvant arm for future randomized trials. PMID:19273696

Menopause and risk of diabetes in the Diabetes Prevention Program

PubMed Central

Kim, Catherine; Edelstein, Sharon L.; Crandall, Jill P.; Dabelea, Dana; Kitabchi, Abbas E.; Hamman, Richard F.; Montez, Maria G.; Perreault, Leigh; Foulkes, Mary A.; Barrett-Connor, Elizabeth

2012-01-01

Objective The study objective was to examine the association between menopause status and diabetes risk among women with glucose intolerance and to determine if menopausal status modifies response to diabetes prevention interventions. Methods The study population included women in premenopause (n=708), natural postmenopause (n=328), and bilateral oophorectomy (n=201) in the Diabetes Prevention Program (DPP), a randomized placebo-controlled trial of lifestyle intervention and metformin among glucose intolerant adults. Associations between menopause and diabetes risk were evaluated using Cox proportional hazard models that adjusted for demographic variables (age, race/ethnicity, family history of diabetes, history of gestational diabetes mellitus), waist circumference, insulin resistance and corrected insulin response. Similar models were constructed after stratification by menopause type and hormone therapy (HT) use. Results After adjustment for age, there was no association between natural menopause or bilateral oophorectomy and diabetes risk. Differences by study arm were observed in women who reported bilateral oophorectomy. In the lifestyle arm, women with bilateral oophorectomy had a lower adjusted hazard for diabetes (HR 0.19, 95% CI 0.04, 0.94), although observations were too few to determine if this was independent of HT use. No significant differences were seen in the metformin (HR 1.29, 95% CI 0.63, 2.64) or placebo arms (HR 1.37, 95% CI 0.74, 2.55). Conclusions Among women at high-risk for diabetes, natural menopause was not associated with diabetes risk and did not affect response to diabetes prevention interventions. In the lifestyle intervention, bilateral oophorectomy was associated with decreased diabetes risk. PMID:21709591

Strategies and Opportunities to STOP Colon Cancer in Priority Populations: Design of a Cluster-Randomized Pragmatic Trial

PubMed Central

Coronado, Gloria D.; Vollmer, William M.; Petrik, Amanda; Taplin, Stephen H.; Burdick, Timothy E.; Meenan, Richard T.; Green, Beverly

2014-01-01

Background Colorectal cancer is the second-leading cause of cancer deaths in the United States. The Strategies and Opportunities to Stop Colorectal Cancer (STOP CRC) in Priority Populations study is a pragmatic trial and a collaboration between two research institutions and a network of more than 200 safety net clinics. The study will assess effectiveness of a systems-based intervention designed to improve rates of colorectal-cancer screening using fecal immunochemical testing (FIT) in federally qualified health centers in Oregon and Northern California. Material and Methods STOP CRC is a cluster-randomized comparative-effectiveness pragmatic trial enrolling 26 clinics. Clinics will be randomized to one of two arms. Clinics in the intervention arm (1) will use an automated, data-driven, electronic health record-embedded program to identify patients due for colorectal screening and mail FIT kits (with pictographic instructions) to them; (2) will conduct an improvement process (e.g. Plan-Do-Study-Act) to enhance the adoption, reach, and effectiveness of the program. Clinics in the control arm will provide opportunistic colorectal-cancer screening to patients at clinic visits. The primary outcomes are: proportion of age– and screening-eligible patients completing a FIT within 12 months; and cost, cost-effectiveness, and return on investment of the intervention. Conclusions This large-scale pragmatic trial will leverage electronic health record information and existing clinic staff to enroll a broad range of patients, including many with historically low colorectal-cancer screening rates. If successful, the program will provide a model for a cost-effective and scalable method to raise colorectal-cancer screening rates. PMID:24937017

The Black Community Perspective: Recruiting Blacks into Combat Arms

DTIC Science & Technology

2013-03-01

relevant data and discusses reasons for the racial imbalance in Combat Arms branches. It also summarizes a qualitative research study involving interviews...racial imbalance in Combat Arms branches. It also summarizes a qualitative research study involving interviews of ten African-American leaders in...representation among general officers, as more than 59% of the Army’s generals are selected from the combat arms. This research study reviews

Improved Outcomes With Retinoic Acid and Arsenic Trioxide Compared With Retinoic Acid and Chemotherapy in Non-High-Risk Acute Promyelocytic Leukemia: Final Results of the Randomized Italian-German APL0406 Trial.

PubMed

Platzbecker, Uwe; Avvisati, Giuseppe; Cicconi, Laura; Thiede, Christian; Paoloni, Francesca; Vignetti, Marco; Ferrara, Felicetto; Divona, Mariadomenica; Albano, Francesco; Efficace, Fabio; Fazi, Paola; Sborgia, Marco; Di Bona, Eros; Breccia, Massimo; Borlenghi, Erika; Cairoli, Roberto; Rambaldi, Alessandro; Melillo, Lorella; La Nasa, Giorgio; Fiedler, Walter; Brossart, Peter; Hertenstein, Bernd; Salih, Helmut R; Wattad, Mohammed; Lübbert, Michael; Brandts, Christian H; Hänel, Mathias; Röllig, Christoph; Schmitz, Norbert; Link, Hartmut; Frairia, Chiara; Pogliani, Enrico Maria; Fozza, Claudio; D'Arco, Alfonso Maria; Di Renzo, Nicola; Cortelezzi, Agostino; Fabbiano, Francesco; Döhner, Konstanze; Ganser, Arnold; Döhner, Hartmut; Amadori, Sergio; Mandelli, Franco; Ehninger, Gerhard; Schlenk, Richard F; Lo-Coco, Francesco

2017-02-20

Purpose The initial results of the APL0406 trial showed that the combination of all- trans-retinoic acid (ATRA) and arsenic trioxide (ATO) is at least not inferior to standard ATRA and chemotherapy (CHT) in first-line therapy of low- or intermediate-risk acute promyelocytic leukemia (APL). We herein report the final analysis on the complete series of patients enrolled onto this trial. Patients and Methods The APL0406 study was a prospective, randomized, multicenter, open-label, phase III noninferiority trial. Eligible patients were adults between 18 and 71 years of age with newly diagnosed, low- or intermediate-risk APL (WBC at diagnosis ≤ 10 × 10 9 /L). Overall, 276 patients were randomly assigned to receive ATRA-ATO or ATRA-CHT between October 2007 and January 2013. Results Of 263 patients evaluable for response to induction, 127 (100%) of 127 patients and 132 (97%) of 136 patients achieved complete remission (CR) in the ATRA-ATO and ATRA-CHT arms, respectively ( P = .12). After a median follow-up of 40.6 months, the event-free survival, cumulative incidence of relapse, and overall survival at 50 months for patients in the ATRA-ATO versus ATRA-CHT arms were 97.3% v 80%, 1.9% v 13.9%, and 99.2% v 92.6%, respectively ( P < .001, P = .0013, and P = .0073, respectively). Postinduction events included two relapses and one death in CR in the ATRA-ATO arm and two instances of molecular resistance after third consolidation, 15 relapses, and five deaths in CR in the ATRA-CHT arm. Two patients in the ATRA-CHT arm developed a therapy-related myeloid neoplasm. Conclusion These results show that the advantages of ATRA-ATO over ATRA-CHT increase over time and that there is significantly greater and more sustained antileukemic efficacy of ATO-ATRA compared with ATRA-CHT in low- and intermediate-risk APL.

Three methods of delivering clinic-based training on syndromic management of sexually transmitted diseases in South Africa: a pilot study

PubMed Central

Weaver, Marcia R; Pillay, Erushka; Jed, Suzanne L; de Kadt, Julia; Galagan, Sean; Gilvydis, Jennifer; Marumo, Eva; Mawandia, Shreshth; Naidoo, Evasen; Owens, Tamara; Prongay, Vickery; O'Malley, Gabrielle

2016-01-01

Introduction The South African National Department of Health sought to improve syndromic management of sexually transmitted infections (STIs). Continuing medical education on STIs was delivered at primary healthcare (PHC) clinics using one of three training methods: (1) lecture, (2) computer and (3) paper-based. Clinics with training were compared with control clinics. Methods Ten PHC clinics were randomly assigned to control and 10 to each training method arm. Clinicians participated in on-site training on six modules; two per week for three weeks. Each clinic was visited by three or four unannounced standardised patient (SP) actors pre-training and post-training. Male SPs reported symptoms of male urethritis syndrome and female SPs reported symptoms of vaginal discharge syndrome. Quality of healthcare was measured by whether or not clinicians completed five tasks: HIV test, genital exam, correct medications, condoms and partner notification. Results An average of 31% of clinicians from each PHC attended each module. Quality of STI care was low. Pre-training (n=128) clinicians completed an average of 1.63 tasks. Post-training (n=114) they completed 1.73. There was no change in the number of STI tasks completed in the control arm and an 11% increase overall in the training arms relative to the control (ratio of relative risk (RRR)=1.11, 95% CI 0.67 to 1.84). Across training arms, there was a 26% increase (RRR=1.26, 95% CI 0.77 to 2.06) associated with lecture, 17% increase (RRR=1.17, 95% CI 0.59 to 2.28) with paper-based and 13% decrease (RRR=0.87, 95% CI 0.40 to 1.90) with computer arm relative to the control. Conclusions Future interventions should address increasing training attendance and computer-based training effectiveness. Trial registration number AEARCTR-0000668. PMID:26430128

Phase III Randomized Trial of Induction Chemotherapy in Patients With N2 or N3 Locally Advanced Head and Neck Cancer

PubMed Central

Cohen, Ezra E.W.; Karrison, Theodore G.; Kocherginsky, Masha; Mueller, Jeffrey; Egan, Robyn; Huang, Chao H.; Brockstein, Bruce E.; Agulnik, Mark B.; Mittal, Bharat B.; Yunus, Furhan; Samant, Sandeep; Raez, Luis E.; Mehra, Ranee; Kumar, Priya; Ondrey, Frank; Marchand, Patrice; Braegas, Bettina; Seiwert, Tanguy Y.; Villaflor, Victoria M.; Haraf, Daniel J.; Vokes, Everett E.

2014-01-01

Purpose Induction chemotherapy (IC) before radiotherapy lowers distant failure (DF) rates in locally advanced squamous cell carcinoma of the head and neck (SCCHN). The goal of this phase III trial was to determine whether IC before chemoradiotherapy (CRT) further improves survival compared with CRT alone in patients with N2 or N3 disease. Patients and Methods Treatment-naive patients with nonmetastatic N2 or N3 SCCHN were randomly assigned to CRT alone (CRT arm; docetaxel, fluorouracil, and hydroxyurea plus radiotherapy 0.15 Gy twice per day every other week) versus two 21-day cycles of IC (docetaxel 75 mg/m2 on day 1, cisplatin 75 mg/m2 on day 1, and fluorouracil 750 mg/m2 on days 1 to 5) followed by the same CRT regimen (IC + CRT arm). The primary end point was overall survival (OS). Secondary end points included DF-free survival, failure pattern, and recurrence-free survival (RFS). Results A total of 285 patients were randomly assigned. The most common grade 3 to 4 toxicities during IC were febrile neutropenia (11%) and mucositis (9%); during CRT (both arms combined), they were mucositis (49%), dermatitis (21%), and leukopenia (18%). Serious adverse events were more common in the IC arm (47% v 28%; P = .002). With a minimum follow-up of 30 months, there were no statistically significant differences in OS (hazard ratio, 0.91; 95% CI, 0.59 to 1.41), RFS, or DF-free survival. Conclusion IC did not translate into improved OS compared with CRT alone. However, the study was underpowered because it did not meet the planned accrual target, and OS was higher than predicted in both arms. IC cannot be recommended routinely in patients with N2 or N3 locally advanced SCCHN. PMID:25049329

Anxiety and Health-Related Quality of Life Among Patients With Low–Tumor Burden Non-Hodgkin Lymphoma Randomly Assigned to Two Different Rituximab Dosing Regimens: Results From ECOG Trial E4402 (RESORT)

PubMed Central

Wagner, Lynne I.; Zhao, Fengmin; Hong, Fangxin; Williams, Michael E.; Gascoyne, Randy D.; Krauss, John C.; Advani, Ranjana H.; Go, Ronald S.; Habermann, Thomas M.; Leach, Joseph W.; O'Connor, Brian; Schuster, Stephen J.; Cella, David; Horning, Sandra J.; Kahl, Brad S.

2015-01-01

Purpose The purpose of this study was to compare illness-related anxiety among participants in the Rituximab Extended Schedule or Retreatment Trial (RESORT) randomly assigned to maintenance rituximab (MR) versus rituximab re-treatment (RR). A secondary objective was to examine whether the superiority of MR versus RR on anxiety depended on illness-related coping style. Patients and Methods Patients (N = 253) completed patient-reported outcome (PRO) measures at random assignment to MR or RR (baseline); at 3, 6, 12, 24, 36, and 48 months after random assignment; and at rituximab failure. PRO measures assessed illness-related anxiety and coping style, and secondary end points including general anxiety, worry and interference with emotional well-being, depression, and health-related quality of life (HRQoL). Patients were classified as using an active or avoidant illness-related coping style. Independent sample t tests and linear mixed-effects models were used to identify treatment arm differences on PRO end points and differences based on coping style. Results Illness-related anxiety was comparable between treatment arms at all time points (P > .05), regardless of coping style (active or avoidant). Illness-related anxiety and general anxiety significantly decreased over time on both arms. HRQoL scores were relatively stable and did not change significantly from baseline for both arms. An avoidant coping style was associated with significantly higher anxiety (18% and 13% exceeded clinical cutoff points at baseline and 6 months, respectively) and poorer HRQoL compared with an active coping style (P < .001), regardless of treatment arm assignment. Conclusion Surveillance until RR at progression was not associated with increased anxiety compared with MR, regardless of coping style. Avoidant coping was associated with higher anxiety and poorer HRQoL. PMID:25605841

Inter-arm blood pressure difference and mortality: a cohort study in an asymptomatic primary care population at elevated cardiovascular risk

PubMed Central

Clark, Christopher E; Taylor, Rod S; Butcher, Isabella; Stewart, Marlene CW; Price, Jackie; Fowkes, F Gerald R; Shore, Angela C; Campbell, John L

2016-01-01

Background Differences in blood pressure between arms are associated with increased cardiovascular mortality in cohorts with established vascular disease or substantially elevated cardiovascular risk. Aim To explore the association of inter-arm difference (IAD) with mortality in a community-dwelling cohort that is free of cardiovascular disease. Design and setting Cohort analysis of a randomised controlled trial in central Scotland, from April 1998 to October 2008. Method Volunteers from Lanarkshire, Glasgow, and Edinburgh, free of pre-existing vascular disease and with an ankle-brachial index ≤0.95, had systolic blood pressure measured in both arms at recruitment. Inter-arm blood pressure differences were calculated and examined for cross-sectional associations and differences in prospective survival. Outcome measures were cardiovascular events and all-cause mortality during mean follow-up of 8.2 years. Results Based on a single pair of measurements, 60% of 3350 participants had a systolic IAD ≥5 mmHg and 38% ≥10 mmHg. An IAD ≥5 mmHg was associated with increased cardiovascular mortality (adjusted hazard ratio [HR] 1.91, 95% confidence interval [CI] = 1.19 to 3.07) and all-cause mortality (adjusted HR 1.44, 95% CI = 1.15 to 1.79). Within the subgroup of 764 participants who had hypertension, IADs of ≥5 mmHg or ≥10 mmHg were associated with both cardiovascular mortality (adjusted HR 2.63, 95% CI = 0.97 to 7.02, and adjusted HR 2.96, 95% CI = 1.27 to 6.88, respectively) and all-cause mortality (adjusted HR 1.67, 95% CI = 1.05 to 2.66, and adjusted HR 1.63, 95% CI = 1.06 to 2.50, respectively). IADs ≥15 mmHg were not associated with survival differences in this population. Conclusion Systolic IADs in blood pressure are associated with increased risk of cardiovascular events, including mortality, in a large cohort of people free of pre-existing vascular disease. PMID:27080315

Safety and Efficacy of HIV Hyperimmune Globulin (HIVIGLOB) for Prevention of Mother-to-Child HIV Transmission in HIV-1 infected Pregnant Women and their Infants in Kampala, Uganda (HIVIGLOB/NVP STUDY)

PubMed Central

Onyango-Makumbi, Carolyne; Omer, Saad B.; Mubiru, Michael; Moulton, Lawrence H.; Nakabiito, Clemensia; Musoke, Philippa; Mmiro, Francis; Zwerski, Sheryl; Wigzell, Hans; Falksveden, Lars; Wahren, Britta; Antelman, Gretchen; Fowler, Mary Glenn; Guay, Laura; Jackson, J. Brooks

2011-01-01

Background This phase III randomized clinical trial compared single dose nevirapine (sdNVP) plus HIV immunoglobulin (HIVIGLOB) to sdNVP alone for preventing maternal-to-child transmission (PMTCT) of HIV. Primary objectives were to determine rates of HIV infection among infants, and to assess the safety of HIVIGLOB in combination with sdNVP in HIV-infected Ugandan pregnant women and their infants. Methods Mother-infant pairs were randomized to receive 200mg of NVP to women in labor and 2mg/kg NVP to newborns within 72 hours after birth (sdNVP arm) or to receive sdNVP plus a single intravenous 240ml dose of HIVIGLOB given to women at 36-38 weeks gestation and a single intravenous 24ml dose to newborns within 18 hours of birth (HIVIGLOB/sdNVP arm). Risk of HIV infection was determined using Kaplan-Meier and risk ratio estimates at birth, 2, 6, 14 weeks, 6 and 12 months of age. Results Intent-to-treat analysis included 198 HIVIGLOB/sdNVP and 294 sdNVP mother-infant pairs. At 6 months of age, the primary endpoint, there was no statistically significant difference in HIV transmission in the HIVIGLOB/sdNVP arm versus the sdNVP arm (18.7% vs.15.0%; RR =1.240 [95% CI: 0.833-1.846]; p= 0.290). Similarly, the proportion of serious adverse events in the HIVIGLOB/sdNVP and sdNVP arms, respectively for mothers (18.9% vs. 19.3%; p= 0.91) and infants (62.6% vs. 59.5%; p=0.51), were not significantly different. Conclusion Giving mother-infant pairs an infusion of peripartum HIV hyperimmunoglobulin in addition to sdNVP for PMTCT was as safe as sdNVP alone, but was no more effective than sdNVP alone in preventing HIV transmission. PMID:21826009

Cortical Plasticity Following Motor Skill Learning During Mental Practice in Stroke1

PubMed Central

Page, Stephen J.; Szaflarski, Jerzy P.; Eliassen, James C.; Pan, Hai; Cramer, Steven C

2012-01-01

Background and Purpose Mental practice (MP), which involves cognitive rehearsal of physical movements, is a non-invasive, inexpensive method of enabling repetitive, task specific practice (RTP). Recent, randomized controlled data suggest that MP, when combined with a RTP therapy program, increases affected arm use and function significantly more than RTP only. As a next step, this 10-subject case series examined the possibility that cortical plasticity is a mechanism underlying the treatment effect of MP when combined with RTP. Method 10 chronic stroke patients (mean = 36.7 months) exhibiting stable, moderate motor deficits received ½ hour therapy sessions for their affected arms, occurring 3 days/week for 10 weeks, and emphasizing valued activities of daily living (ADLs). Directly after therapy, subjects received 30-minute MP sessions, which required MP of the ADLs performed during therapy. Behavioral outcomes were blindly evaluated using the Action Research Arm Test (ARAT) and the Fugl-Meyer Assessment (FM). Functional magnetic resonance imaging (fMRI) was administered before and after intervention to assess cortical changes. Results Before intervention, subjects exhibited stable motor deficits. After intervention, subjects exhibited marked ARAT and FM score increases (+ 5.3 and + 4.2, respectively), and clinically significant, new abilities to perform valued ADLs. Post-intervention fMRI revealed significant increases in activation to wrist flexion and extension of the affected hand in the premotor area and primary motor cortex ipsi- and contralaterally to the affected hand, and superior parietal cortex ipsilateral to the affected hand. Decreased activations were noted in parietal cortex of the hemisphere ipsilateral to the affected hand. These changes correlated with anatomical regions in which behavioral changes were observed via the ARAT and FM. Conclusions MP is an easy to use, cost effective strategy that was again shown to improve affected arm outcomes after stroke. This is the first study suggesting alteration in the cortical map as a possible MP mechanism for the affected arm. PMID:19155350

Disclosing Pleiotropic Effects during Genetic Risk Assessment for Alzheimer’s Disease: A Randomized, Controlled Trial

PubMed Central

Christensen, Kurt D.; Roberts, J. Scott; Whitehouse, Peter J.; Royal, Charmaine D. M.; Obisesan, Thomas O.; Cupples, L. Adrienne; Vernarelli, Jacqueline A.; Bhatt, Deepak L.; Linnenbringer, Erin; Butson, Melissa B.; Fasaye, Grace-Ann; Uhlmann, Wendy R.; Hiraki, Susan; Wang, Na; Cook-Deegan, Robert; Green, Robert C.

2016-01-01

Background Increasing use of genetic testing raises questions about disclosing secondary findings, including pleiotropic information. Objective To determine the safety and behavioral impact of disclosing modest associations between APOE genotype and coronary artery disease (CAD) risk during APOE-based genetic risk assessments for Alzheimer’s disease (AD). Design Randomized, multicenter equivalence clinical trial Setting Four teaching hospitals Participants 257 asymptomatic adults enrolled, 69% with one AD-affected first degree relative Intervention Disclosing AD and CAD genetic risk information (AD+CAD) versus disclosing only AD genetic risk (AD-only) Measurements Co-primary outcomes were Beck Anxiety Index (BAI) and Center for Epidemiologic Studies Depression Scale (CES-D) scores at 12 months. Secondary outcomes included test-related distress at 12 months, all measures at 6 weeks and 6 months, and health behavior changes at 12 months. Results 12 months after disclosure, mean BAI scores were 3.5 and 3.5 in AD-only and AD+CAD arms (Δ=0.0, 95%CI: −1.0 to 1.0), and mean CES-D scores were 6.4 and 7.1 in AD-only and AD+CAD arms (Δ=0.7, 95%CI: −1.0 to 2.4). Both confidence bounds fell within the equivalence margin of +/−5 points. Among ε4-positive participants, distress was lower in AD+CAD arms than AD-only arms (Δ=−4.8, 95%CI: −8.6 to −1.0) (p=0.031 for disclosure arm x APOE genotype). AD+CAD participants also reported more health behavior changes, regardless of APOE genotype. Limitations Outcomes were self-reported from volunteers without severe anxiety, severe depression, or cognitive problems. Analyses omitted 33 randomized participants. Conclusion Disclosing pleiotropic information did not increase anxiety or depression, and may have decreased distress among those at increased risk for two conditions. Providing risk modification information regarding CAD improved health behaviors. Findings highlight potential benefits of secondary genetic findings disclosure when options exist for decreasing risk. PMID:26810768

Induction Speed Is Not a Determinant of Propofol Pharmacodynamics

PubMed Central

Doufas, Anthony G.; Bakhshandeh, Maryam; Bjorksten, Andrew R.; Shafer, Steven L.; Sessler, Daniel I.

2005-01-01

Summary We used individual pharmacodynamic modeling to demonstrate that different sedation endpoints occur at the same effect site propofol concentration, independent of the infusion rate of propofol. Background Evidence suggests that the rate at which they are infused may influence plasma-effect site equilibration of intravenous anesthetics. We used 5 different rates of propofol administration to test the hypothesis that different sedation endpoints occur at the same effect site propofol concentration, independent of the infusion rate. We concurrently evaluated the automated responsiveness monitor (ARM) against other sedation measures and the propofol effect site concentration. Methods With Human Studies Committee approval, 18 healthy volunteers received 5 consecutive target-controlled propofol infusions. During each infusion the effect site concentration was increased by a rate of 0.1, 0.3, 0.5, 0.7, or 0.9 μg·ml−1·min−1. Bispectral index and ARM were recorded at frequent intervals. The times of syringe drop and loss and recovery of responsiveness were noted. Pharmacokinetic and pharmacodynamic modeling was performed using NONMEM. Results Once the correct rate of plasma-effect site equilibration (ke0) was determined for each individual (ke0 = 0.17 min−1, time-to-peak effect = 2.7 min), the effect site concentrations associated with each clinical measure were not affected by the rate of rise of effect site propofol concentration. ARM correlated with all clinical measures of drug effect. Subjects invariably stopped responding to ARM at lower effect site propofol concentrations than those associated with loss of responsiveness. Conclusions Population-based pharmacokinetics, combined with real-time electroencephalographic measures of drug effect, may provide a means to individualize pharmacodynamic modeling during target-controlled drug delivery. ARM appears useful as an automated measure of sedation and may provide the basis for automated monitoring and titration of sedation for a propofol delivery system. PMID:15505446

Arm pain in youth baseball players: a survey of healthy players.

PubMed

Makhni, Eric C; Morrow, Zachary S; Luchetti, Timothy J; Mishra-Kalyani, Pallavi S; Gualtieri, Anthony P; Lee, Randall W; Ahmad, Christopher S

2015-01-01

Overuse injury in youth baseball players is increasing in prevalence, and these injuries have been correlated to pitching mechanics and pitch counts/types. Prior studies regarding arm pain in these athletes have focused simply on presence or absence of pain during the season rather than on detailed factors related to arm pain with respect to frequency, severity, and associated performance and psychosocial effect. The goal of this study was to investigate frequency, quality, and effect of arm pain in healthy youth baseball players. The hypothesis was that arm pain will affect a majority of healthy baseball players and will be associated with adverse psychosocial effects. Descriptive epidemiological study. A novel survey focusing on arm pain in youth baseball players was developed for the purpose of this study. Survey questions were formulated by a consortium of trainers, clinicians, and coaches. Surveys were administered to healthy youth baseball players throughout the states of New Jersey and New York. A total of 203 healthy players completed the survey; 23% of players (n=47) reported a prior overuse injury. Only 26% and 20% of players reported that their arm never hurt when throwing or the day after throwing, respectively; 30% of players reported that arm pain at least sometimes caused them to have less fun playing; and 46% of players reported at least once being encouraged to keep playing despite having arm pain. Pitchers were more likely to report arm pain while throwing and the day after throwing and to indicate that arm pain held them back from being a better player (all P<.05). Those with prior overuse injury were more likely to have arm pain while throwing, to have arm fatigue during a game or practice, and to be encouraged to keep playing despite having pain (all P<.05). A majority of healthy (actively competing) youth baseball players report at least some baseline arm pain and fatigue, and many players suffer adverse psychosocial effects from this pain. © 2014 The Author(s).

Effect of Neoadjuvant Chemotherapy Followed by Surgical Resection on Survival in Patients With Limited Metastatic Gastric or Gastroesophageal Junction Cancer

PubMed Central

Homann, Nils; Pauligk, Claudia; Illerhaus, Gerald; Martens, Uwe M.; Stoehlmacher, Jan; Schmalenberg, Harald; Luley, Kim B.; Prasnikar, Nicole; Egger, Matthias; Probst, Stephan; Messmann, Helmut; Moehler, Markus; Fischbach, Wolfgang; Hartmann, Jörg T.; Mayer, Frank; Höffkes, Heinz-Gert; Koenigsmann, Michael; Arnold, Dirk; Kraus, Thomas W.; Grimm, Kersten; Berkhoff, Stefan; Post, Stefan; Jäger, Elke; Bechstein, Wolf; Ronellenfitsch, Ulrich; Mönig, Stefan; Hofheinz, Ralf D.

2017-01-01

Importance Surgical resection has a potential benefit for patients with metastatic adenocarcinoma of the stomach and gastroesophageal junction. Objective To evaluate outcome in patients with limited metastatic disease who receive chemotherapy first and proceed to surgical resection. Design, Setting, and Participants The AIO-FLOT3 (Arbeitsgemeinschaft Internistische Onkologie–fluorouracil, leucovorin, oxaliplatin, and docetaxel) trial is a prospective, phase 2 trial of 252 patients with resectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Patients were enrolled from 52 cancer care centers in Germany between February 1, 2009, and January 31, 2010, and stratified to 1 of 3 groups: resectable (arm A), limited metastatic (arm B), or extensive metastatic (arm C). Data cutoff was January 2012, and the analysis was performed in March 2013. Interventions Patients in arm A received 4 preoperative cycles of fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) followed by surgery and 4 postoperative cycles. Patients in arm B received at least 4 cycles of neoadjuvant FLOT and proceeded to surgical resection if restaging (using computed tomography and magnetic resonance imaging) showed a chance of margin-free (R0) resection of the primary tumor and at least a macroscopic complete resection of the metastatic lesions. Patients in arm C were offered FLOT chemotherapy and surgery only if required for palliation. Patients received a median (range) of 8 (1-15) cycles of FLOT. Main Outcomes and Measures The primary end point was overall survival. Results In total, 238 of 252 patients (94.4%) were eligible to participate. The median (range) age of participants was 66 (36-79) years in arm A (n = 51), 63 (28-79) years in arm B (n = 60), and 65 (23-83) years in arm C (n = 127). Patients in arm B (n = 60) had only retroperitoneal lymph node involvement (27 patients [45%]), liver involvement (11 [18.3%]), lung involvement (10 [16.7%]), localized peritoneal involvement (4 [6.7%]), or other (8 [13.3%]) incurable sites. Median overall survival was 22.9 months (95% CI, 16.5 to upper level not achieved) for arm B, compared with 10.7 months (95% CI, 9.1-12.8) for arm C (hazard ratio, 0.37; 95% CI, 0.25-0.55) (P < .001). The response rate for arm B was 60% (complete, 10%; partial, 50%), which is higher than the 43.3% for arm C. In arm B, 36 of 60 patients (60%) proceeded to surgery. The median overall survival was 31.3 months (95% CI, 18.9-upper level not achieved) for patients who proceeded to surgery and 15.9 months (95% CI, 7.1-22.9) for the other patients. Conclusions and Relevance Patients with limited metastatic disease who received neoadjuvant chemotherapy and proceeded to surgery showed a favorable survival. The AIO-FLOT3 trial provides a rationale for further randomized clinical trials. Trial Registration clinicaltrials.gov identifier: NCT00849615 PMID:28448662

Characterization of chromosomal architecture in Arabidopsis by chromosome conformation capture

PubMed Central

2013-01-01

Background The packaging of long chromatin fibers in the nucleus poses a major challenge, as it must fulfill both physical and functional requirements. Until recently, insights into the chromosomal architecture of plants were mainly provided by cytogenetic studies. Complementary to these analyses, chromosome conformation capture technologies promise to refine and improve our view on chromosomal architecture and to provide a more generalized description of nuclear organization. Results Employing circular chromosome conformation capture, this study describes chromosomal architecture in Arabidopsis nuclei from a genome-wide perspective. Surprisingly, the linear organization of chromosomes is reflected in the genome-wide interactome. In addition, we study the interplay of the interactome and epigenetic marks and report that the heterochromatic knob on the short arm of chromosome 4 maintains a pericentromere-like interaction profile and interactome despite its euchromatic surrounding. Conclusion Despite the extreme condensation that is necessary to pack the chromosomes into the nucleus, the Arabidopsis genome appears to be packed in a predictive manner, according to the following criteria: heterochromatin and euchromatin represent two distinct interactomes; interactions between chromosomes correlate with the linear position on the chromosome arm; and distal chromosome regions have a higher potential to interact with other chromosomes. PMID:24267747

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

The impact of a disease management program (COACH) on the attainment of better cardiovascular risk control in dyslipidaemic patients at primary care centres (The DISSEMINATE Study): a randomised controlled trial

PubMed Central

2012-01-01

Background To evaluate the efficacy of Counselling and Advisory Care for Health (COACH) programme in managing dyslipidaemia among primary care practices in Malaysia. This open-label, parallel, randomised controlled trial compared the COACH programme delivered by primary care physicians alone (PCP arm) and primary care physicians assisted by nurse educators (PCP-NE arm). Methods This was a multi-centre, open label, randomised trial of a disease management programme (COACH) among dyslipidaemic patients in 21 Malaysia primary care practices. The participating centres enrolled 297 treatment naïve subjects who had the primary diagnosis of dyslipidaemia; 149 were randomised to the COACH programme delivered by primary care physicians assisted by nurse educators (PCP-NE) and 148 to care provided by primary care physicians (PCP) alone. The primary efficacy endpoint was the mean percentage change from baseline LDL-C at week 24 between the 2 study arms. Secondary endpoints included mean percentage change from baseline of lipid profile (TC, LDL-C, HDL-C, TG, TC: HDL ratio), Framingham Cardiovascular Health Risk Score and absolute risk change from baseline in blood pressure parameters at week 24. The study also assessed the sustainability of programme efficacy at week 36. Results Both study arms demonstrated improvement in LDL-C from baseline. The least squares (LS) mean change from baseline LDL-C were −30.09% and −27.54% for PCP-NE and PCP respectively. The difference in mean change between groups was 2.55% (p=0.288), with a greater change seen in the PCP-NE arm. Similar observations were made between the study groups in relation to total cholesterol change at week 24. Significant difference in percentage change from baseline of HDL-C were observed between the PCP-NE and PCP groups, 3.01%, 95% CI 0.12-5.90, p=0.041, at week 24. There was no significant difference in lipid outcomes between 2 study groups at week 36 (12 weeks after the programme had ended). Conclusion Patients who received coaching and advice from primary care physicians (with or without the assistance by nurse educators) showed improvement in LDL-cholesterol. Disease management services delivered by PCP-NE demonstrated a trend towards add-on improvements in cholesterol control compared to care delivered by physicians alone; however, the improvements were not maintained when the services were withdrawn. Trial registration National Medical Research Registration (NMRR) Number: NMRR-08-287-1442 Trial Registration Number (ClinicalTrials.gov Identifier): NCT00708370 PMID:23046818

Relationship between weight loss and parameters of skeletal muscle function in patients with advanced cancer and fatigue.

PubMed

Morgado, P Cresta; Giorlando, A; Castro, M; Navigante, A

2016-09-01

This study aims to determine the influence of significant weight loss on parameters of skeletal muscle function in a population of advanced cancer patients with fatigue. A cross-sectional and comparative study was designed between two arms of advanced cancer patients with fatigue (fatigue numeral scale (FNS) ≥4). A arm (n = 27) with ≥5 % weight loss in the last 6 months, and B arm (n = 22) without weight loss. Muscle strength was examined by hand grip technique and measurements of body composition by bioimpedance analysis (BIA), values of hemoglobin, albumin, lactic dehydrogenase (LDH), c-reactive protein (CRP), urine creatinine, and FNS. These variables were compared between both groups and correlated within each group. here were no differences concerning parameters of muscle strength between both arms. A arm had values of CRP ≥10 ug/dl in 77 % compared with 38.5 % of B arm (p = 0.004). A arm showed a higher percentage of body cell mass (%BCM) than B arm (p = 0.005). The A arm also showed a lower percentage of fat mass (%FM) (p = 0.014) when compared to the B arm. FNS was higher in A arm (median 7 vs 5; p = 0.047). All the variables of muscle strength had a significant positive correlation. In A arm, BCM had a negative significant correlation with CRP (p = 0.021). In this study, significant weight loss and high CRP did not have influence on parameters of skeletal muscular function. We consider that further studies should be necessary, preferably with longitudinal designs to evaluate these findings.

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.

The Effect of Restricted Arm Swing on Energy Expenditure in Healthy Men

ERIC Educational Resources Information Center

Yizhar, Ziva; Boulos, Spiro; Inbar, Omri; Carmeli, Eli

2009-01-01

Arm swing in human walking is an active natural motion involving the upper extremities. Earlier studies have described the interrelationship between arms and legs during walking, but the effect of arm swing on energy expenditure and dynamic parameters during normal gait, is inconclusive. The aim of this study was to investigate the effect of…

The rotate-plus-shift C-arm trajectory. Part I. Complete data with less than 180° rotation

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

Ritschl, Ludwig; Fleischmann, Christof; Kuntz, Jan, E-mail: j.kuntz@dkfz.de

Purpose: In the last decade, C-arm-based cone-beam CT became a widely used modality for intraoperative imaging. Typically a C-arm CT scan is performed using a circular or elliptical trajectory around a region of interest. Therefore, an angular range of at least 180° plus fan angle must be covered to ensure a completely sampled data set. However, mobile C-arms designed with a focus on classical 2D applications like fluoroscopy may be limited to a mechanical rotation range of less than 180° to improve handling and usability. The method proposed in this paper allows for the acquisition of a fully sampled datamore » set with a system limited to a mechanical rotation range of at least 180° minus fan angle using a new trajectory design. This enables CT like 3D imaging with a wide range of C-arm devices which are mainly designed for 2D imaging. Methods: The proposed trajectory extends the mechanical rotation range of the C-arm system with two additional linear shifts. Due to the divergent character of the fan-beam geometry, these two shifts lead to an additional angular range of half of the fan angle. Combining one shift at the beginning of the scan followed by a rotation and a second shift, the resulting rotate-plus-shift trajectory enables the acquisition of a completely sampled data set using only 180° minus fan angle of rotation. The shifts can be performed using, e.g., the two orthogonal positioning axes of a fully motorized C-arm system. The trajectory was evaluated in phantom and cadaver examinations using two prototype C-arm systems. Results: The proposed trajectory leads to reconstructions without limited angle artifacts. Compared to the limited angle reconstructions of 180° minus fan angle, image quality increased dramatically. Details in the rotate-plus-shift reconstructions were clearly depicted, whereas they are dominated by artifacts in the limited angle scan. Conclusions: The method proposed here employs 3D imaging using C-arms with less than 180° rotation range adding full 3D functionality to a C-arm device retaining both handling comfort and the usability of 2D imaging. This method has a clear potential for clinical use especially to meet the increasing demand for an intraoperative 3D imaging.« less

Effects of dominant and non-dominant passive arm manoeuvres on the neurovascular coupling response.

PubMed

Llwyd, Osian; Panerai, Ronney B; Robinson, Thompson G

2017-11-01

Models designed to study neurovascular coupling (NVC) describe a possible cerebral hemisphere dominance dependent on task completed and preference in handedness. We investigated whether passive arm manoeuvre performed with dominant (Dom-Arm) or non-dominant arm (ND-Arm) stimulated haemodynamic differences in either contralateral (Cont-H) or ipsilateral (Ipsil-H) cerebral hemisphere. Healthy individuals lying in supine position, had measurements of beat-to-beat blood pressure (BP, mmHg), electrocardiogram (HR, bpm), end-tidal CO 2 (etCO 2 , mmHg), and bilateral insonation of the middle cerebral arteries (MCA, cm s -1 ). Arm movement was performed for 60 s with passive flexion and extension of the elbow (1 Hz), before manoeuvre was repeated on other arm. Data were normalised and effect of treatment was analysed for differences between manoeuvres and within each time period. Seventeen (eight males) healthy volunteers, aged 56 ± 7 years, were studied. Dom-Arm and ND-Arm manoeuvres stimulated a comparable temporal response in peripheral and cerebral haemodynamic parameters between Cont-H and Ipsil-H. Both manoeuvres can be used to evoke similar bilateral MCA responses in assessing NVC. This finding should lead to more efficient protocols when using passive arm movement for NVC studies in healthy subjects.

Arm span as a proxy measure for height and estimation of nutritional status: a study among Dhimals of Darjeeling in West Bengal India.

PubMed

Datta Banik, Sudip

2011-11-01

This study aimed to understand the interrelationship between height and arm span and also to estimate nutritional status from arm span. In an anthropometric survey conducted among the Dhimals (227 males and 223 females, total = 450) of Naxalbari in West Bengal, India, measurements were recorded in age groups ranging between 10-59 years. Males were taller and had longer arm spans than females. The height-arm span ratio was 0.98-0.99, indicating height to be slightly less than arm span in both sexes. High correlation between these two dimensions was also observed. Regression equations provided a good model for estimating height from arm span (predictor). In all age groups of both sexes, values of standardized coefficient beta exhibited high significance (p ( 0.001). Residuals showed no pattern and were random. No significant difference between height-based body mass index or BMI (body weight/height(2)) and estimated arm span-based BMI (body weight/arm span(2)) was observed in any age group. Arm span was found to be an effective surrogate measure for BMI.

The Relationship of Throwing Arm Mechanics and Elbow Varus Torque: Within-Subject Variation for Professional Baseball Pitchers Across 82,000 Throws.

PubMed

Camp, Christopher L; Tubbs, Travis G; Fleisig, Glenn S; Dines, Joshua S; Dines, David M; Altchek, David W; Dowling, Brittany

2017-11-01

Likely due to the high level of strain exerted across the elbow during the throwing motion, elbow injuries are on the rise in baseball. To identify at-risk athletes and guide postinjury return-to-throw programs, a better understanding of the variables that influence elbow varus torque is desired. To describe the within-subject relationship between elbow varus torque and arm slot and arm rotation in professional baseball pitchers. Descriptive laboratory study. A total of 81 professional pitchers performed 82,000 throws while wearing a motusBASEBALL sensor and sleeve. These throws represented a combination of throw types, such as warm-up/catch, structured long-toss, bullpen throwing from a mound, and live game activity. Variables recorded for each throw included arm slot (angle of the forearm relative to the ground at ball release), arm speed (maximal rotational velocity of the forearm), arm rotation (maximal external rotation of the throwing arm relative to the ground), and elbow varus torque. Linear mixed-effects models and likelihood ratio tests were used to estimate the relationship between elbow varus torque and arm slot, arm speed, and arm rotation within individual pitchers. All 3 metrics-arm slot (χ 2 = 428, P < .001), arm speed (χ 2 = 57,683, P < .001), and arm rotation (χ 2 = 1392, P < .001)-were found to have a significant relationship with elbow varus torque. Within individual athletes, a 1-N.m increase in elbow varus torque was associated with a 13° decrease in arm slot, a 116 deg/s increase in arm speed, and an 8° increase in arm rotation. Elbow varus torque increased significantly as pitchers increased their arm rotation during the arm cocking phase, increased the rotational velocity of their arm during the arm acceleration phase of throwing, and decreased arm slot at ball release. Thus, shoulder flexibility, arm speed, and elbow varus torque (and likely injury risk) are interrelated and should be considered collectively when treating pitchers. It is well established that elbow varus torque is related to ulnar collateral ligament injuries in overhead throwers. This study describes the relationship of arm slot, arm speed, and arm rotation to elbow varus torque in an attempt to identify modifiable risk factors for injury.

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

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.

Direct provision versus facility collection of HIV self-tests among female sex workers in Uganda: A cluster-randomized controlled health systems trial

PubMed Central

Kibuuka Musoke, Daniel; Ngabirano, Thomson; Nakitende, Aidah; Magoola, Jonathan; Kayiira, Prossy; Taasi, Geoffrey; Barresi, Leah G.; McConnell, Margaret A.; Bärnighausen, Till

2017-01-01

Background HIV self-testing allows HIV testing at any place and time and without health workers. HIV self-testing may thus be particularly useful for female sex workers (FSWs), who should test frequently but face stigma and financial and time barriers when accessing healthcare facilities. Methods and findings We conducted a cluster-randomized controlled health systems trial among FSWs in Kampala, Uganda, to measure the effect of 2 HIV self-testing delivery models on HIV testing and linkage to care outcomes. FSW peer educator groups (1 peer educator and 8 participants) were randomized to either (1) direct provision of HIV self-tests, (2) provision of coupons for free collection of HIV self-tests in a healthcare facility, or (3) standard of care HIV testing. We randomized 960 participants in 120 peer educator groups from October 18, 2016, to November 16, 2016. Participants’ median age was 28 years (IQR 24–32). Our prespecified primary outcomes were self-report of any HIV testing at 1 month and at 4 months; our prespecified secondary outcomes were self-report of HIV self-test use, seeking HIV-related medical care and ART initiation. In addition, we analyzed 2 secondary outcomes that were not prespecified: self-report of repeat HIV testing—to understand the intervention effects on frequent testing—and self-reported facility-based testing—to quantify substitution effects. Participants in the direct provision arm were significantly more likely to have tested for HIV than those in the standard of care arm, both at 1 month (risk ratio [RR] 1.33, 95% CI 1.17–1.51, p < 0.001) and at 4 months (RR 1.14, 95% CI 1.07–1.22, p < 0.001). Participants in the direct provision arm were also significantly more likely to have tested for HIV than those in the facility collection arm, both at 1 month (RR 1.18, 95% CI 1.07–1.31, p = 0.001) and at 4 months (RR 1.03, 95% CI 1.01–1.05, p = 0.02). At 1 month, fewer participants in the intervention arms had sought medical care for HIV than in the standard of care arm, but these differences were not significant and were reduced in magnitude at 4 months. There were no statistically significant differences in ART initiation across study arms. At 4 months, participants in the direct provision arm were significantly more likely to have tested twice for HIV than those in the standard of care arm (RR 1.51, 95% CI 1.29–1.77, p < 0.001) and those in the facility collection arm (RR 1.22, 95% CI 1.08–1.37, p = 0.001). Participants in the HIV self-testing arms almost completely replaced facility-based testing with self-testing. Two adverse events related to HIV self-testing were reported: interpersonal violence and mental distress. Study limitations included self-reported outcomes and limited generalizability beyond FSWs in similar settings. Conclusions In this study, HIV self-testing appeared to be safe and increased recent and repeat HIV testing among FSWs. We found that direct provision of HIV self-tests was significantly more effective in increasing HIV testing among FSWs than passively offering HIV self-tests for collection in healthcare facilities. HIV self-testing could play an important role in supporting HIV interventions that require frequent HIV testing, such as HIV treatment as prevention, behavior change for transmission reduction, and pre-exposure prophylaxis. Trial registration ClinicalTrials.gov NCT02846402 PMID:29182634

32 CFR 11.3 - General.

Code of Federal Regulations, 2010 CFR

2010-07-01

... crimes and elements derive from the law of armed conflict, a body of law that is sometimes referred to as... with that body of law, are triable by military commission. Because this document is declarative of... of other laws. No conclusion regarding the applicability or persuasive authority of other bodies of...

32 CFR 11.3 - General.

Code of Federal Regulations, 2014 CFR

2014-07-01

... crimes and elements derive from the law of armed conflict, a body of law that is sometimes referred to as... with that body of law, are triable by military commission. Because this document is declarative of... of other laws. No conclusion regarding the applicability or persuasive authority of other bodies of...

32 CFR 11.3 - General.

Code of Federal Regulations, 2013 CFR

2013-07-01

... crimes and elements derive from the law of armed conflict, a body of law that is sometimes referred to as... with that body of law, are triable by military commission. Because this document is declarative of... of other laws. No conclusion regarding the applicability or persuasive authority of other bodies of...

32 CFR 11.3 - General.

Code of Federal Regulations, 2011 CFR

2011-07-01

... crimes and elements derive from the law of armed conflict, a body of law that is sometimes referred to as... with that body of law, are triable by military commission. Because this document is declarative of... of other laws. No conclusion regarding the applicability or persuasive authority of other bodies of...

32 CFR 11.3 - General.

Code of Federal Regulations, 2012 CFR

2012-07-01

... crimes and elements derive from the law of armed conflict, a body of law that is sometimes referred to as... with that body of law, are triable by military commission. Because this document is declarative of... of other laws. No conclusion regarding the applicability or persuasive authority of other bodies of...

Armed with Information: Evolving Public Affairs to Deliver Operational Effects

DTIC Science & Technology

2009-04-01

Recommendations and Conclusions The epitome of skill is to defeat your enemy without physically engaging him in battle. —Sun Szu Evolving existing PA...Applied Warfare Course coursebook , edited by Sharon McBride, 19-36. Maxwell AFB, AL: Air University Press, October 2008. Krepinevich, Andrew F

Accuracy of a Fourth-Generation Subcutaneous Continuous Glucose Sensor

PubMed Central

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

2017-01-01

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

Prevalence and clinical implications of the inter-arm blood pressure difference: A systematic review.

PubMed

Clark, C E; Campbell, J L; Evans, P H; Millward, A

2006-12-01

A blood pressure (BP) difference between arms was first reported over 100 years ago. Knowledge of its prevalence and relevance to the accurate measurement of BP remains poor. Current hypertension guidelines do not emphasise it. The objectives of this study were to establish the best estimate of prevalence of the inter-arm difference (IAD) in the population, to consider its implications for accurate BP measurement and treatment, and to discuss its aetiology and potential as a risk marker for cardiovascular disease. Systematic literature review was carried out. The data sources were Medline EMBASE and CINAHL databases, and Index of Theses. Studies reporting prevalence rates of IAD were retrieved and considered for inclusion against explicit methodological criteria. Point prevalence rates were extracted and weighted mean prevalence rates calculated. The main outcome measures were weighted mean prevalences of systolic IAD > or =10 and > or =20 mm Hg and of diastolic IAD > or =10 mm Hg. Thirty-one studies were identified. Most had methodological weaknesses; only four met the inclusion criteria. Pooled prevalences of the IAD from these four studies were 19.6% systolic > or =10 mm Hg (95% CI 18.0-21.3%), 4.2% systolic > or =20 mm Hg (95% CI 3.4-5.1%) and 8.1% diastolic > or =10 mm Hg (95%CI 6.9-9.2%). In conclusion, an IAD is present in a substantial number of patients and should be looked for whenever diagnosis and treatment depend on accurate measurements of BP. The importance of an IAD should be better emphasised in current hypertension management guidelines. There is evidence associating an IAD with peripheral vascular disease, raising the possibility that its presence may predict cardiovascular events.

Another face of placebo: The lessebo effect in Parkinson disease

PubMed Central

Mestre, Tiago A.; Shah, Prakesh; Marras, Connie; Tomlinson, George

2014-01-01

Objective: To study the impact of negative expectation related to receiving a placebo (the “lessebo effect”) on efficacy outcome measures of symptomatic treatments in Parkinson disease (PD). Methods: We conducted meta-analyses of double-blind randomized controlled trials (RCTs) of dopamine agonists in PD and compared the pooled mean score change of the motor section of the Unified Parkinson's Disease Rating Scale (mUPDRS) across active treatment arms according to the presence of a placebo arm or the probability of placebo assignment (0%, <50%, and 50%) of the original RCT. A mixed-effects model was used. Heterogeneity was assessed by subgroup analyses and meta-regression modeling. Results: A total of 28 study arms were extracted from active-controlled trials (3,277 patients) and 42 from placebo-controlled trials (4,554 patients). The overall difference between groups in the pooled mean score change in the mUPDRS was 1.6 units (95% confidence interval [CI] 0.2, 3.0; p = 0.023), in favor of the active-controlled group. In subgroup analyses, this difference was of higher magnitude in the early PD group without motor fluctuations (3.3 mUPDRS units, 95% CI 1.1, 5.4; p = 0.003) and for study duration ≤12 weeks (4.1 mUPDRS units, 95% CI 1.0, 7.2; p = 0.009). There was no between-group difference using probability of placebo assignment as criterion. Conclusions: This study shows that the use of a placebo can be associated with a clinically significant reduction in the magnitude of change of the mUPDRS after an active treatment in RCTs for PD. These new findings have potential implications in the development of new treatments and appraisal of current treatment options for PD and possibly for other neurologic disorders. PMID:24658930

Sometimes two arms are enough--an unusual life-stage in brittle stars (Echinodermata: Ophiuroidea).

PubMed

Stöhr, Sabine; Alme, Øydis

2015-08-03

Off West Africa (Angola-Morocco), benthos samples were collected in the years 2005-2012. These contained 124 specimens of brittle stars with two long arms and three extremely short or absent arms and an elongated, narrow disc. These unusual brittle stars, as well as 33 specimens with five fully developed arms, were identified as Amphiura ungulata. The specimens with unequal arms were juvenile stages, whereas adults had five equal arms. The large number of specimens with unequal arms suggests that this condition is not the result of damage and regeneration, but a normal growth pattern in this species. This study documents the morphology by SEM, amends the species description, and discusses possible explanations for the evolution of this condition. Although brittle star species with unequal arm growth have been reported, this is an extreme case that was unknown before this study.

A Unified Approach for Reporting ARM Measurement Uncertainties Technical Report

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

Campos, E; Sisterson, Douglas

The U.S. Department of Energy (DOE) Atmospheric Radiation Measurement (ARM) Climate Research Facility is observationally based, and quantifying the uncertainty of its measurements is critically important. With over 300 widely differing instruments providing over 2,500 datastreams, concise expression of measurement uncertainty is quite challenging. The ARM Facility currently provides data and supporting metadata (information about the data or data quality) to its users through a number of sources. Because the continued success of the ARM Facility depends on the known quality of its measurements, the Facility relies on instrument mentors and the ARM Data Quality Office (DQO) to ensure, assess,more » and report measurement quality. Therefore, an easily accessible, well-articulated estimate of ARM measurement uncertainty is needed. Note that some of the instrument observations require mathematical algorithms (retrievals) to convert a measured engineering variable into a useful geophysical measurement. While those types of retrieval measurements are identified, this study does not address particular methods for retrieval uncertainty. As well, the ARM Facility also provides engineered data products, or value-added products (VAPs), based on multiple instrument measurements. This study does not include uncertainty estimates for those data products. We propose here that a total measurement uncertainty should be calculated as a function of the instrument uncertainty (calibration factors), the field uncertainty (environmental factors), and the retrieval uncertainty (algorithm factors). The study will not expand on methods for computing these uncertainties. Instead, it will focus on the practical identification, characterization, and inventory of the measurement uncertainties already available in the ARM community through the ARM instrument mentors and their ARM instrument handbooks. As a result, this study will address the first steps towards reporting ARM measurement uncertainty: 1) identifying how the uncertainty of individual ARM measurements is currently expressed, 2) identifying a consistent approach to measurement uncertainty, and then 3) reclassifying ARM instrument measurement uncertainties in a common framework.« less

A randomized clinical trial of adjuvant chemotherapy with doxorubicin, ifosfamide, and cisplatin followed by radiotherapy versus radiotherapy alone in patients with localized uterine sarcomas (SARCGYN study). A study of the French Sarcoma Group.

PubMed

Pautier, P; Floquet, A; Gladieff, L; Bompas, E; Ray-Coquard, I; Piperno-Neumann, S; Selle, F; Guillemet, C; Weber, B; Largillier, R; Bertucci, F; Opinel, P; Duffaud, F; Reynaud-Bougnoux, A; Delcambre, C; Isambert, N; Kerbrat, P; Netter-Pinon, G; Pinto, N; Duvillard, P; Haie-Meder, C; Lhommé, C; Rey, A

2013-04-01

There is no proven benefit of adjuvant treatment of uterine sarcoma (US). SARCGYN phase III study compared adjuvant polychemotherapy followed by pelvic radiotherapy (RT) (arm A) versus RT alone (arm B) conducted to detect an increase ≥ 20% of 3-year PFS. Patients with FIGO stage ≤ III US, physiological age ≤ 65 years; chemotherapy: four cycles of doxorubicin 50 mg/m² d1, ifosfamide 3 g/m²/day d1-2, cisplatin 75 mg/m² d3, (API) + G-CSF q 3 weeks. Study was stopped because of lack of recruitment. Eighty-one patients were included: 39 in arm A and 42 in arm B; 52 stage I, 16 stage II, 13 stage III; 53 leiomyosarcomas, 9 undifferenciated sarcomas, 19 carcinosarcomas. Gr 3-4 toxicity during API (/37 patients): thrombopenia (76%), febrile neutropenia (22%) with two toxic deaths; renal gr 3 (1 patient). After a median follow-up of 4.3 years, 41/81 patients recurred, 15 in arm A, 26 in arm B. The 3 years DFS is 55% in arm A, 41% in arm B (P = 0.048). The 3-year overall survival (OS) is 81% in arm A and 69% in arm B (P = 0.41). API adjuvant CT statistically increases the 3 year-DFS of patients with US.

Possibility of star (pyramid) dune development in the area of bimodal wind regime

NASA Astrophysics Data System (ADS)

Biejat, K.

2012-04-01

Star (pyramid) dunes are the largest aeolian landforms. They can occur in three types - simple, complex and compound. Development of this type of dunes is usually connected with multidirectional or complex wind regimes. The aim of this study was to verify a hypothesis that the star dunes can also develop by a bimodal wind regime and by local modifications of nearsurface wind flow directions. Field study was performed on Erg Chebbi, in southern Morocco. Several star and transverse dunes were selected for the study of their shape. The star dunes were analysed concerning their type and position in the dune field. This erg contains all of three types of star dunes together with transverse dunes. The regional wind data show that there are two dominant wind directions - NE (Chergui) and SW (Saheli). To determine the difference in shape of star dunes, we performed topographic surveying by GPS RTK. The results allowed to create 3D models of star dunes. The models were used to determine metric characteristics of star dunes, including area of dune basis, volume, and slope angles. On the basis of 3D models, primary, secondary and, on the compound dunes, tertiary arms were determined. Primary arms on each type of star dunes, as well as crestlines of transverse dunes, have dominant orientation NW-SE, perpendicular to two dominant wind directions. This clearly confirms that star dunes of Erg Chebbi develop by a bimodal wind regime In contrast to primary arms, subsidiary (secondary and tertiary) arms are not connected to general wind regime. The secondary arms of star dunes occur to be differentially developer. There are more subsidiary arms on SW sides in comparison to the E sides of the dunes where inclination of slopes is constant. It can be therefore inferred that sand has been supplied predominantly from SW direction. This is supported by distribution of the dunes on the erg. Most compound star dunes compose a chain along the E margin of the erg. Comparison of compound star dunes located in E and W parts of the erg allow inferring that there must have been differences in supply of the aeolian sand. Eastern slopes of compound star dunes developed in the W part of the erg are inclined 10-15°. This shows that significant delivery of the sand must have occurred also from NE. Eastern slopes of compound star dunes located in the E part of the erg are inclined 20-30°. It can be therefore inferred that they have functioned mainly as lee slopes and the sand was delivery from SW. This proves that location of the dunes within the erg plays a significant role in shaping wind directions responsible for delivery of the sand. Orientation of subsidiary arms does not show any relationship with general wind regime, which leads to conclusion that the subsidiary arms develop due to local diversified regime of nearsurface wind flow. This is governed by barriers such as the star dunes themselves and not by other topographic obstacles.

A prospective randomized multicenter trial of amnioreduction versus selective fetoscopic laser photocoagulation for the treatment of severe twin–twin transfusion syndrome

PubMed Central

Crombleholme, Timothy M.; Shera, David; Lee, Hanmin; Johnson, Mark; D’Alton, Mary; Porter, Flint; Chyu, Jacquelyn; Silver, Richard; Abuhamad, Alfred; Saade, George; Shields, Laurence; Kauffman, David; Stone, Joanne; Albanese, Craig T.; Bahado-Singh, Ray; Ball, Robert H.; Bilaniuk, Larissa; Coleman, Beverly; Farmer, Diana; Feldstein, Vickie; Harrison, Michael R.; Hedrick, Holly; Livingston, Jeffrey; Lorenz, Robert P.; Miller, David A.; Norton, Mary E.; Polzin, William J.; Robinson, Julian N.; Rychik, Jack; Sandberg, Per L.; Seri, Istvan; Simon, Erin; Simpson, Lynn L.; Yedigarova, Larisa; Wilson, R. Douglas; Young, Bruce

2009-01-01

Objective To examine the effect of selective fetoscopic laser photocoagulation (SFLP) versus serial amnioreduction (AR) on perinatal mortality in severe twin-twin transfusion syndrome (TTTS). Study Design 5-year multicenter prospective randomized controlled trial. The primary outcome variable was 30-day postnatal survival of donors and recipients. Results There is no statistically significant difference in 30-day postnatal survival between SFLP or AR treatment for donors at 55% (11/20) vs 55% (11/20) (p=1, OR=1, 95%CI=0.242 to 4.14) or recipients at 30% (6/20) vs 45% (9/20) (p=0.51, OR=1.88, 95%CI=0.44 to 8.64). There is no difference in 30-day survival of one or both twins on a per pregnancy basis between AR at 75% (15/20) and SFLP at 65% (13/20) (p=0.73, OR=1.62, 95%CI=0.34 to 8.09). Overall survival (newborns divided by the number of fetuses treated) is not statistically significant for AR at 60% (24/40) vs SFLP 45% (18/40) (p=0.18, OR=2.01, 95%CI=0.76 to 5.44). There is a statistically significant increase in fetal recipient mortality in the SFLP arm at 70% (14/20) versus the AR arm at 35% (7/20) (p=0.25, OR=5.31, 95%CI=1.19 to 27.6). This is offset by increased recipient neonatal mortality of 30% (6/20) in the AR arm. Echocardiographic abnormality in recipient twin Cardiovascular Profile Score is the most significant predictor of recipient mortality (p=0.055, OR=3.025/point) by logistic regression analysis. Conclusions The outcome of the trial does not conclusively determine whether AR or SFLP is a superior treatment modality. TTTS cardiomyopathy appears to be an important factor in recipient survival in TTTS. PMID:17904975

Carbon dioxide insufflation during colonoscopy in deeply sedated patients

PubMed Central

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

2012-01-01

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

mRNA Levels of Placental Iron and Zinc Transporter Genes Are Upregulated in Gambian Women with Low Iron and Zinc Status.

PubMed

Jobarteh, Modou Lamin; McArdle, Harry J; Holtrop, Grietje; Sise, Ebrima A; Prentice, Andrew M; Moore, Sophie E

2017-07-01

Background: The role of the placenta in regulating micronutrient transport in response to maternal status is poorly understood. Objective: We investigated the effect of prenatal nutritional supplementation on the regulation of placental iron and zinc transport. Methods: In a randomized trial in rural Gambia [ENID (Early Nutrition and Immune Development)], pregnant women were allocated to 1 of 4 nutritional intervention arms: 1 ) iron and folic acid (FeFol) tablets (FeFol group); 2 ) multiple micronutrient (MMN) tablets (MMN group); 3 ) protein energy (PE) as a lipid-based nutrient supplement (LNS; PE group); and 4 ) PE and MMN (PE+MMN group) as LNS. All arms included iron (60 mg/d) and folic acid (400 μg/d). The MMN and PE+MMN arms included 30 mg supplemental Zn/d. In a subgroup of ∼300 mother-infant pairs, we measured maternal iron status, mRNA levels of genes encoding for placental iron and zinc transport proteins, and cord blood iron levels. Results: Maternal plasma iron concentration in late pregnancy was 45% and 78% lower in the PE and PE+MMN groups compared to the FeFol and MMN groups, respectively ( P < 0.001). The mRNA levels of the placental iron uptake protein transferrin receptor 1 were 30-49% higher in the PE and PE+MMN arms than in the FeFol arm ( P < 0.031), and also higher in the PE+MMN arm (29%; P = 0.042) than in the MMN arm. Ferritin in infant cord blood was 18-22% lower in the LNS groups ( P < 0.024). Zinc supplementation in the MMN arm was associated with higher maternal plasma zinc concentrations (10% increase; P < 0.001) than in other intervention arms. mRNA levels for intracellular zinc-uptake proteins, in this case zrt, irt-like protein (ZIP) 4 and ZIP8, were 96-205% lower in the PE+MMN arm than in the intervention arms without added zinc ( P < 0.025). Furthermore, mRNA expression of ZIP1 was 85% lower in the PE+MMN group than in the PE group ( P = 0.003). Conclusion: In conditions of low maternal iron and in the absence of supplemental zinc, the placenta upregulates the gene expression of iron and zinc uptake proteins, presumably in order to meet fetal demands in the face of low maternal supply. The ENID trial was registered at www.controlled-trials.com as ISRCTN49285450.

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

Multi-Parametric Spinal Cord MRI as Potential Progression Marker in Amyotrophic Lateral Sclerosis

PubMed Central

El Mendili, Mohamed-Mounir; Cohen-Adad, Julien; Pelegrini-Issac, Mélanie; Rossignol, Serge; Morizot-Koutlidis, Régine; Marchand-Pauvert, Véronique; Iglesias, Caroline; Sangari, Sina; Katz, Rose; Lehericy, Stéphane; Benali, Habib; Pradat, Pierre-François

2014-01-01

Objective To evaluate multimodal MRI of the spinal cord in predicting disease progression and one-year clinical status in amyotrophic lateral sclerosis (ALS) patients. Materials and Methods After a first MRI (MRI1), 29 ALS patients were clinically followed during 12 months; 14/29 patients underwent a second MRI (MRI2) at 11±3 months. Cross-sectional area (CSA) that has been shown to be a marker of lower motor neuron degeneration was measured in cervical and upper thoracic spinal cord from T2-weighted images. Fractional anisotropy (FA), axial/radial/mean diffusivities (λ⊥, λ//, MD) and magnetization transfer ratio (MTR) were measured within the lateral corticospinal tract in the cervical region. Imaging metrics were compared with clinical scales: Revised ALS Functional Rating Scale (ALSFRS-R) and manual muscle testing (MMT) score. Results At MRI1, CSA correlated significantly (P<0.05) with MMT and arm ALSFRS-R scores. FA correlated significantly with leg ALFSRS-R scores. One year after MRI1, CSA predicted (P<0.01) arm ALSFSR-R subscore and FA predicted (P<0.01) leg ALSFRS-R subscore. From MRI1 to MRI2, significant changes (P<0.01) were detected for CSA and MTR. CSA rate of change (i.e. atrophy) highly correlated (P<0.01) with arm ALSFRS-R and arm MMT subscores rate of change. Conclusion Atrophy and DTI metrics predicted ALS disease progression. Cord atrophy was a better biomarker of disease progression than diffusion and MTR. Our study suggests that multimodal MRI could provide surrogate markers of ALS that may help monitoring the effect of disease-modifying drugs. PMID:24755826

Cost-effectiveness of parenteral artesunate for treating children with severe malaria in sub-Saharan Africa

PubMed Central

Riewpaiboon, Arthorn; Dondorp, Arjen M; von Seidlein, Lorenz; Mokuolu, Olugbenga A; Nansumba, Margaret; Gesase, Samwel; Kent, Alison; Mtove, George; Olaosebikan, Rasaq; Ngum, Wirichada Pan; Fanello, Caterina I; Hendriksen, Ilse; Day, Nicholas PJ; White, Nicholas J; Yeung, Shunmay

2011-01-01

Abstract Objective To explore the cost-effectiveness of parenteral artesunate for the treatment of severe malaria in children and its potential impact on hospital budgets. Methods The costs of inpatient care of children with severe malaria were assessed in four of the 11 sites included in the African Quinine Artesunate Malaria Treatment trial, conducted with over 5400 children. The drugs, laboratory tests and intravenous fluids provided to 2300 patients from admission to discharge were recorded, as was the length of inpatient stay, to calculate the cost of inpatient care. The data were matched with pooled clinical outcomes and entered into a decision model to calculate the cost per disability-adjusted life year (DALY) averted and the cost per death averted. Findings The mean cost of treating severe malaria patients was similar in the two study groups: 63.5 United States dollars (US$) (95% confidence interval, CI: 61.7–65.2) in the quinine arm and US$ 66.5 (95% CI: 63.7–69.2) in the artesunate arm. Children treated with artesunate had 22.5% lower mortality than those treated with quinine and the same rate of neurological sequelae: (artesunate arm: 2.3 DALYs per patient; quinine arm: 3.0 DALYs per patient). Compared with quinine as a baseline, artesunate showed an incremental cost per DALY averted and an incremental cost per death averted of US$ 3.8 and US$ 123, respectively. Conclusion Artesunate is a highly cost-effective and affordable alternative to quinine for treating children with severe malaria. The budgetary implications of adopting artesunate for routine use in hospital-based care are negligible. PMID:21734764

Use of C-Arm Cone Beam CT During Hepatic Radioembolization: Protocol Optimization for Extrahepatic Shunting and Parenchymal Enhancement

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

Hoven, Andor F. van den, E-mail: a.f.vandenhoven@umcutrecht.nl; Prince, Jip F.; Keizer, Bart de

PurposeTo optimize a C-arm computed tomography (CT) protocol for radioembolization (RE), specifically for extrahepatic shunting and parenchymal enhancement.Materials and MethodsA prospective development study was performed per IDEAL recommendations. A literature-based protocol was applied in patients with unresectable and chemorefractory liver malignancies undergoing an angiography before radioembolization. Contrast and scan settings were adjusted stepwise and repeatedly reviewed in a consensus meeting. Afterwards, two independent raters analyzed all scans. A third rater evaluated the SPECT/CT scans as a reference standard for extrahepatic shunting and lack of target segment perfusion.ResultsFifty scans were obtained in 29 procedures. The first protocol, using a 6 s delaymore » and 10 s scan, showed insufficient parenchymal enhancement. In the second protocol, the delay was determined by timing parenchymal enhancement on DSA power injection (median 8 s, range 4–10 s): enhancement improved, but breathing artifacts increased (from 0 to 27 %). Since the third protocol with a 5 s scan decremented subjective image quality, the second protocol was deemed optimal. Median CNR (range) was 1.7 (0.6–3.2), 2.2 (−1.4–4.0), and 2.1 (−0.3–3.0) for protocol 1, 2, and 3 (p = 0.80). Delineation of perfused segments was possible in 57, 73, and 44 % of scans (p = 0.13). In all C-arm CTs combined, the negative predictive value was 95 % for extrahepatic shunting and 83 % for lack of target segment perfusion.ConclusionAn optimized C-arm CT protocol was developed that can be used to detect extrahepatic shunts and non-perfusion of target segments during RE.« less

Bioefficacy of Mentha piperita essential oil against dengue fever mosquito Aedes aegypti L

PubMed Central

Kumar, Sarita; Wahab, Naim; Warikoo, Radhika

2011-01-01

Objective To assess the larvicidal and repellent potential of the essential oil extracted from the leaves of peppermint plant, Mentha piperita (M. piperita) against the larval and adult stages of Aedes aegypti (Ae. Aegypti). Methods The larvicidal potential of peppermint oil was evaluated against early fourth instar larvae of Ae. aegypti using WHO protocol. The mortality counts were made after 24 and 48 h, and LC50 and LC90 values were calculated. The efficacy of peppermint oil as mosquito repellent was assessed using the human-bait technique. The measured area of one arm of a human volunteer was applied with the oil and the other arm was applied with ethanol. The mosquito bites on both the arms were recorded for 3 min after every 15 min. The experiment continued for 3 h and the percent protection was calculated. Results The essential oil extracted from M. piperita possessed excellent larvicidal efficiency against dengue vector. The bioassays showed an LC50 and LC90 value of 111.9 and 295.18 ppm, respectively after 24 h of exposure. The toxicity of the oil increased 11.8% when the larvae were exposed to the oil for 48 h. The remarkable repellent properties of M. piperita essential oil were established against adults Ae. aegypti. The application of oil resulted in 100% protection till 150 min. After next 30 min, only 1-2 bites were recorded as compared with 8-9 bites on the control arm. Conclusions The peppermint essential oil is proved to be efficient larvicide and repellent against dengue vector. Further studies are needed to identify the possible role of oil as adulticide, oviposition deterrent and ovicidal agent. The isolation of active ingredient from the oil could help in formulating strategies for mosquito control. PMID:23569733

Remote Ischemic Postconditioning (RIPC) of the Upper Arm Results in Protection from Cardiac Ischemia-Reperfusion Injury Following Primary Percutaneous Coronary Intervention (PCI) for Acute ST-Segment Elevation Myocardial Infarction (STEMI)

PubMed Central

Cao, Bangming; Wang, Haipeng; Zhang, Chi; Xia, Ming

2018-01-01

Background The aim of this study was to evaluate the role of remote ischemic postconditioning (RIPC) of the upper arm on protection from cardiac ischemia-reperfusion injury following primary percutaneous coronary intervention (PCI) in patients with acute ST-segment elevation myocardial infarction (STEMI). Material/Methods Eighty patients with STEMI were randomized into two groups: primary PCI (N=44) and primary PCI+RIPC (N=36). RIPC consisted of four cycles of 5 minutes of occlusion and five minutes of reperfusion by cuff inflation and deflation of the upper arm, commencing within one minute of the first PCI balloon dilatation. Peripheral venous blood samples were collected before PCI and at 0.5, 8, 24, 48, and 72 hours after PCI. Levels of creatine kinase-MB (CK-MB), serum creatinine (Cr), nitric oxide (NO), and stromal cell-derived factor-1α (SDF-1α) were measured. The rates of acute kidney injury (AKI) and the estimated glomerular filtration rate (eGFR) were calculated. Results Patients in the primary PCI+RIPC group, compared with the primary PCI group, had significantly lower peak CK-MB concentrations (P<0.01), a significantly increased left ventricular ejection fraction (LVEF) (P=0.01), a significantly lower rate of AKI (P<0.01) a significantly increased eGFR (P<0.01), and decreased area under the curve (AUC) of CK-MB, NO and SDF-1α. Conclusions RIPC of the upper arm following primary PCI in patients with acute STEMI might provide cardiac and renal protection from ischemia-reperfusion injury via the actions of SDF-1α, and NO. PMID:29456238

Remote Ischemic Postconditioning (RIPC) of the Upper Arm Results in Protection from Cardiac Ischemia-Reperfusion Injury Following Primary Percutaneous Coronary Intervention (PCI) for Acute ST-Segment Elevation Myocardial Infarction (STEMI).

PubMed

Cao, Bangming; Wang, Haipeng; Zhang, Chi; Xia, Ming; Yang, Xiangjun

2018-02-19

BACKGROUND The aim of this study was to evaluate the role of remote ischemic postconditioning (RIPC) of the upper arm on protection from cardiac ischemia-reperfusion injury following primary percutaneous coronary intervention (PCI) in patients with acute ST-segment elevation myocardial infarction (STEMI). MATERIAL AND METHODS Eighty patients with STEMI were randomized into two groups: primary PCI (N=44) and primary PCI+RIPC (N=36). RIPC consisted of four cycles of 5 minutes of occlusion and five minutes of reperfusion by cuff inflation and deflation of the upper arm, commencing within one minute of the first PCI balloon dilatation. Peripheral venous blood samples were collected before PCI and at 0.5, 8, 24, 48, and 72 hours after PCI. Levels of creatine kinase-MB (CK-MB), serum creatinine (Cr), nitric oxide (NO), and stromal cell-derived factor-1α (SDF-1α) were measured. The rates of acute kidney injury (AKI) and the estimated glomerular filtration rate (eGFR) were calculated. RESULTS Patients in the primary PCI+RIPC group, compared with the primary PCI group, had significantly lower peak CK-MB concentrations (P<0.01), a significantly increased left ventricular ejection fraction (LVEF) (P=0.01), a significantly lower rate of AKI (P<0.01) a significantly increased eGFR (P<0.01), and decreased area under the curve (AUC) of CK-MB, NO and SDF-1α. CONCLUSIONS RIPC of the upper arm following primary PCI in patients with acute STEMI might provide cardiac and renal protection from ischemia-reperfusion injury via the actions of SDF-1α, and NO.

Long-Term Follow-up of Participants with Heart Failure in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)

PubMed Central

Piller, Linda B.; Baraniuk, Sarah; Simpson, Lara M.; Cushman, William C.; Massie, Barry M.; Einhorn, Paula T.; Oparil, Suzanne; Ford, Charles E.; Graumlich, James F.; Dart, Richard A.; Parish, David C.; Retta, Tamrat M.; Cuyjet, Aloysius B.; Jafri, Syed Z.; Furberg, Curt D.; Saklayen, Mohammad G.; Thadani, Udho; Probstfield, Jeffrey L.; Davis, Barry R.

2011-01-01

Background In the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), a randomized, double-blind, practice-based, active-control, comparative effectiveness trial in high-risk hypertensive participants, risk of new-onset heart failure (HF) was higher in the amlodipine (2.5-10 mg/day) and lisinopril (10-40 mg/day) arms compared with the chlorthalidone (12.5-25 mg/day) arm . Similar to other studies, mortality rates following new-onset HF were very high (≥50% at 5 years), and were similar across randomized treatment arms. After the randomized phase of the trial ended in 2002, outcomes were determined from administrative databases. Methods and Results Using national databases, post-trial follow-up mortality through 2006 was obtained on participants who developed new-onset HF during the randomized (in-trial) phase of ALLHAT. Mean follow-up for the entire period was 8.9 years. Of 1761 participants with incident HF in-trial, 1348 died. Post-HF all-cause mortality was similar across treatment groups with adjusted hazard ratios (95% confidence intervals) of 0.95 (0.81-1.12) and 1.05 (0.89-1.25), respectively, for amlodipine and lisinopril compared with chlorthalidone, and 10-year adjusted rates of 86%, 87%, and 83%, respectively. All-cause mortality rates were also similar among those with reduced ejection fractions (84%) and preserved ejection fractions (81%) with no significant differences by randomized treatment arm. Conclusions Once HF develops, risk of death is high and consistent across randomized treatment groups. Measures to prevent the development of HF, especially blood pressure control, must be a priority if mortality associated with development of HF is to be addressed. PMID:21969009