Reducing angiographic cystoid macular edema and blood-aqueous barrier disruption after small-incision phacoemulsification and foldable intraocular lens implantation: multicenter prospective randomized comparison of topical diclofenac 0.1% and betamethasone 0.1%.

PubMed

Asano, Sayaka; Miyake, Kensaku; Ota, Ichiro; Sugita, Gentaro; Kimura, Wataru; Sakka, Yuji; Yabe, Nobuyuki

2008-01-01

To compare the effectiveness of a topical nonsteroidal drug (diclofenac 0.1%) and a topical steroidal drug (betamethasone 0.1%) in preventing cystoid macular edema (CME) and blood-aqueous barrier (BAB) disruption after small-incision cataract surgery and foldable intraocular lens (IOL) implantation. Shohzankai Medical Foundation Miyake Eye Hospital, Tokyo, Japan. This multicenter interventional double-masked randomized study comprised 142 patients having phacoemulsification and foldable IOL implantation. Seventy-one patients were randomized to receive diclofenac eyedrops and 71, betamethasone eyedrops for 8 weeks postoperatively. The incidence and severity of CME were evaluated by fluorescein angiography. Blood-aqueous barrier disruption was determined by laser flare-cell photometry. Of the patients, 63 were men and 79 were women. Five weeks after surgery, the incidence of fluorescein angiographic CME was lower in the diclofenac group (18.8%) than in the betamethasone group (58.0%) (P<.001). At 1 and 2 weeks, the amount of anterior chamber flare was statistically significantly less in the diclofenac group than in the betamethasone group (P<.05). At 8 weeks, intraocular pressure was statistically significantly higher in the betamethasone group (P = .0003). Diclofenac was more effective than betamethasone in preventing angiographic CME and BAB disruption after small-incision cataract surgery. Thus, nonsteroidal antiinflammatory agents should be considered for routine treatment of eyes having cataract surgery.

Metacontrast masking and attention do not interact.

PubMed

Agaoglu, Sevda; Breitmeyer, Bruno; Ogmen, Haluk

2016-07-01

Visual masking and attention have been known to control the transfer of information from sensory memory to visual short-term memory. A natural question is whether these processes operate independently or interact. Recent evidence suggests that studies that reported interactions between masking and attention suffered from ceiling and/or floor effects. The objective of the present study was to investigate whether metacontrast masking and attention interact by using an experimental design in which saturation effects are avoided. We asked observers to report the orientation of a target bar randomly selected from a display containing either two or six bars. The mask was a ring that surrounded the target bar. Attentional load was controlled by set-size and masking strength by the stimulus onset asynchrony between the target bar and the mask ring. We investigated interactions between masking and attention by analyzing two different aspects of performance: (i) the mean absolute response errors and (ii) the distribution of signed response errors. Our results show that attention affects observers' performance without interacting with masking. Statistical modeling of response errors suggests that attention and metacontrast masking exert their effects by independently modulating the probability of "guessing" behavior. Implications of our findings for models of attention are discussed.

Clobetasol propionate shampoo 0.05% and calcipotriol solution 0.005%: a randomized comparison of efficacy and safety in subjects with scalp psoriasis.

PubMed

Reygagne, P; Mrowietz, U; Decroix, J; de Waard-van der Spek, F B; Acebes, L Olmos; Figueiredo, A; Caputo, R; Poncet, M; Arsonnaud, S

2005-02-01

Scalp involvement in psoriatic patients represents a common issue. Treatment of the hairy skin requires adequate pharmaceutical formulations; hence, a new specific shampoo formulation of clobetasol propionate 0.05% was developed by Galderma R&D, Inc. For this multicenter, randomized, investigator-masked, parallel group study, 151 subjects with moderate to severe scalp psoriasis were randomized to 4 weeks of treatment with clobetasol propionate shampoo or calcipotriol solution. Clobetasol propionate demonstrated significantly superior efficacy to calcipotriol solution (total severity score: mean difference 0.51, 95% CI 0.05-0.97, p = 0.028; global severity score: mean difference 0.43, 95% CI 0.08-0.78, p = 0.016). Adverse events were more common in the calcipotriol group than in the clobetasol propionate shampoo group. Telangiectasia and skin atrophy did not differ significantly between treatments; however, a burning sensation was significantly more common in the calcipotriol solution group. Short contact therapy of scalp psoriasis with this new shampoo formulation of clobetasol propionate was significantly more effective and better tolerated than calcipotriol solution for the treatment of scalp psoriasis.

Parametric and non-parametric masking of randomness in sequence alignments can be improved and leads to better resolved trees.

PubMed

Kück, Patrick; Meusemann, Karen; Dambach, Johannes; Thormann, Birthe; von Reumont, Björn M; Wägele, Johann W; Misof, Bernhard

2010-03-31

Methods of alignment masking, which refers to the technique of excluding alignment blocks prior to tree reconstructions, have been successful in improving the signal-to-noise ratio in sequence alignments. However, the lack of formally well defined methods to identify randomness in sequence alignments has prevented a routine application of alignment masking. In this study, we compared the effects on tree reconstructions of the most commonly used profiling method (GBLOCKS) which uses a predefined set of rules in combination with alignment masking, with a new profiling approach (ALISCORE) based on Monte Carlo resampling within a sliding window, using different data sets and alignment methods. While the GBLOCKS approach excludes variable sections above a certain threshold which choice is left arbitrary, the ALISCORE algorithm is free of a priori rating of parameter space and therefore more objective. ALISCORE was successfully extended to amino acids using a proportional model and empirical substitution matrices to score randomness in multiple sequence alignments. A complex bootstrap resampling leads to an even distribution of scores of randomly similar sequences to assess randomness of the observed sequence similarity. Testing performance on real data, both masking methods, GBLOCKS and ALISCORE, helped to improve tree resolution. The sliding window approach was less sensitive to different alignments of identical data sets and performed equally well on all data sets. Concurrently, ALISCORE is capable of dealing with different substitution patterns and heterogeneous base composition. ALISCORE and the most relaxed GBLOCKS gap parameter setting performed best on all data sets. Correspondingly, Neighbor-Net analyses showed the most decrease in conflict. Alignment masking improves signal-to-noise ratio in multiple sequence alignments prior to phylogenetic reconstruction. Given the robust performance of alignment profiling, alignment masking should routinely be used to improve tree reconstructions. Parametric methods of alignment profiling can be easily extended to more complex likelihood based models of sequence evolution which opens the possibility of further improvements.

Using a high-flow nasal cannula provides superior results to OxyMask delivery in moderate to severe bronchiolitis: a randomized controlled study.

PubMed

Ergul, Ayse Betul; Calıskan, Emrah; Samsa, Hasan; Gokcek, Ikbal; Kaya, Ali; Zararsiz, Gozde Erturk; Torun, Yasemin Altuner

2018-06-18

The effectiveness of using a face mask with a small diffuser for oxygen delivery (OxyMask) was compared to use of a high-flow nasal cannula (HFNC) in patients with moderate or severe bronchiolitis.The study population in this open, phase 4, randomized controlled trial consisted of 60 patients aged 1-24 months diagnosed with moderate or severe bronchiolitis and admitted to an intensive care unit (ICU) for oxygen therapy. The patients were randomized into two groups according to the method of oxygen delivery: a diffuser mask group and an HFNC group.There were seven failures in the mask group and none in the HFNC group. The survival probability differed significantly between the two treatment methods (p = 0.009).Time to weaning off oxygen therapy was 56 h in the HFNC group and 96 h in the mask group (p < 0.001). HFNC use decreased the treatment failure rate and the duration of both oxygen therapy and ICU treatment compared to the diffuser mask, which implies that an HFNC should be the first choice for treating patients admitted to the ICU with severe bronchiolitis. What is known: • A high-flow nasal cannula (HFNC) does not significantly reduce the time on oxygen compared to standard therapy in children with moderate to severe bronchiolitis. Observational studies show that, since the introduction of HFNC, fewer children with bronchiolitis need intubation. For children with moderate to severe bronchiolitis there is no proof of its benefit. What Is New: • In children with moderate to severe bronchiolitis, HFNC provides faster and more effective improvement than can be achieved with a diffuser mask.

Cone-Beam CT Assessment of Interfraction and Intrafraction Setup Error of Two Head-and-Neck Cancer Thermoplastic Masks

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

Velec, Michael; Waldron, John N.; O'Sullivan, Brian

2010-03-01

Purpose: To prospectively compare setup error in standard thermoplastic masks and skin-sparing masks (SSMs) modified with low neck cutouts for head-and-neck intensity-modulated radiation therapy (IMRT) patients. Methods and Materials: Twenty head-and-neck IMRT patients were randomized to be treated in a standard mask (SM) or SSM. Cone-beam computed tomography (CBCT) scans, acquired daily after both initial setup and any repositioning, were used for initial and residual interfraction evaluation, respectively. Weekly, post-IMRT CBCT scans were acquired for intrafraction setup evaluation. The population random (sigma) and systematic (SIGMA) errors were compared for SMs and SSMs. Skin toxicity was recorded weekly by use ofmore » Radiation Therapy Oncology Group criteria. Results: We evaluated 762 CBCT scans in 11 patients randomized to the SM and 9 to the SSM. Initial interfraction sigma was 1.6 mm or less or 1.1 deg. or less for SM and 2.0 mm or less and 0.8 deg. for SSM. Initial interfraction SIGMA was 1.0 mm or less or 1.4 deg. or less for SM and 1.1 mm or less or 0.9 deg. or less for SSM. These errors were reduced before IMRT with CBCT image guidance with no significant differences in residual interfraction or intrafraction uncertainties between SMs and SSMs. Intrafraction sigma and SIGMA were less than 1 mm and less than 1 deg. for both masks. Less severe skin reactions were observed in the cutout regions of the SSM compared with non-cutout regions. Conclusions: Interfraction and intrafraction setup error is not significantly different for SSMs and conventional masks in head-and-neck radiation therapy. Mask cutouts should be considered for these patients in an effort to reduce skin toxicity.« less

Associative and repetition priming with the repeated masked prime technique: no priming found.

PubMed

Avons, S E; Russo, Riccardo; Cinel, Caterina; Verolini, Veronica; Glynn, Kevin; McDonald, Rebecca; Cameron, Marie

2009-01-01

Wentura and Frings (2005) reported evidence of subliminal categorical priming on a lexical decision task, using a new method of visual masking in which the prime string consisted of the prime word flanked by random consonants and random letter masks alternated with the prime string on successive refresh cycles. We investigated associative and repetition priming on lexical decision, using the same method of visual masking. Three experiments failed to show any evidence of associative priming, (1) when the prime string was fixed at 10 characters (three to six flanking letters) and (2) when the number of flanking letters were reduced or absent. In all cases, prime detection was at chance level. Strong associative priming was observed with visible unmasked primes, but the addition of flanking letters restricted priming even though prime detection was still high. With repetition priming, no priming effects were found with the repeated masked technique, and prime detection was poor but just above chance levels. We conclude that with repeated masked primes, there is effective visual masking but that associative priming and repetition priming do not occur with experiment-unique prime-target pairs. Explanations for this apparent discrepancy across priming paradigms are discussed. The priming stimuli and prime-target pairs used in this study may be downloaded as supplemental materials from mc.psychonomic-journals.org/content/supplemental.

A randomized, masked comparison of topical ketorolac 0.4% plus steroid vs steroid alone in low-risk cataract surgery patients.

PubMed

Wittpenn, John R; Silverstein, Steven; Heier, Jeffrey; Kenyon, Kenneth R; Hunkeler, John D; Earl, Melissa

2008-10-01

To evaluate whether adding perioperative topical ketorolac tromethamine 0.4% improves cataract surgery outcomes relative to topical steroids alone in patients without known risk factors for cystoid macular edema (CME). Prospective, randomized, investigator-masked, multicenter clinical trial. Patients scheduled to undergo phacoemulsification and with no recognized CME risks (diabetic retinopathy, retinal vascular disease, or macular abnormality) were randomized to receive either prednisolone acetate 1% 4 times daily (QID) alone (steroid group; n = 278) or prednisolone 1% QID plus ketorolac 0.4% QID (ketorolac/steroid group; n = 268) for approximately four weeks postoperatively. In the ketorolac/steroid group, patients also received topical ketorolac 0.4% QID for three days preoperatively. In both groups, patients received four doses of ketorolac 0.4% one hour before surgery. Patients with capsular disruption or vitreous loss intraoperatively were exited from the study. Outcome measures included CME incidence, retinal thickness as measured by optical coherence tomography (OCT), best-corrected visual acuity, and contrast sensitivity. No patients in the ketorolac/steroid group and five patients in the steroid group had clinically apparent CME (P = .032). Based on OCT, no ketorolac/steroid patient had definite or probable CME, compared with six steroid patients (2.4%; P = .018). In the ketorolac/steroid group, mean retinal thickening was less (3.9 microm vs 9.6 microm; P = .003), and fewer patients had retinal thickening of more than 10 microm as compared with the steroid group (26% vs 51%; P < .001). This study suggests that adding perioperative ketorolac to postoperative prednisolone significantly reduces the incidences of CME and macular thickening in cataract surgery patients already at low risk for this condition.

Latanoprostene Bunod 0.024% in Subjects With Open-angle Glaucoma or Ocular Hypertension: Pooled Phase 3 Study Findings.

PubMed

Weinreb, Robert N; Liebmann, Jeffrey M; Martin, Keith R; Kaufman, Paul L; Vittitow, Jason L

2018-01-01

To compare the diurnal intraocular pressure (IOP)-lowering effect of latanoprostene bunod (LBN) 0.024% with timolol maleate 0.5% in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT). Pooled analysis of two phase 3, randomized, multicenter, double-masked, parallel-group, noninferiority trials (APOLLO and LUNAR), each with open-label safety extension phases. Adults with OAG or OHT were randomized 2:1 to double-masked treatment with LBN once daily (qd) or timolol twice daily (bid) for 3 months followed by open-label LBN treatment for 3 (LUNAR) or 9 (APOLLO) months. IOP was measured at 8 AM, 12 PM, and 4 PM at week 2, week 6, and months 3, 6, 9, and 12. Of the 840 subjects randomized, 774 (LBN, n=523; timolol crossover to LBN, n=251) completed the efficacy phase, and 738 completed the safety extension phase. Mean IOP was significantly lower with LBN versus timolol at all 9 evaluation timepoints during the efficacy phase (P<0.001). A significantly greater proportion of LBN-treated subjects attained a mean IOP ≤18 mm Hg and IOP reduction ≥25% from baseline versus timolol-treated subjects (P<0.001). The IOP reduction with LBN was sustained through the safety phase; subjects crossed over from timolol to LBN experienced additional significant IOP lowering (P≤0.009). Both treatments were well tolerated, and there were no safety concerns with long-term LBN treatment. In this pooled analysis of subjects with OAG and OHT, LBN 0.024% qd provided greater IOP-lowering compared with timolol 0.5% bid and maintained lowered IOP through 12 months. LBN demonstrated a safety profile comparable to that of prostaglandin analogs.

Tolerability of loteprednol/tobramycin versus dexamethasone/tobramycin in healthy volunteers: results of a 4-week, randomized, double-masked, parallel-group study.

PubMed

Bartlett, Jimmy D; Holland, Edward J; Usner, Dale W; Paterno, Michael R; Comstock, Timothy L

2008-08-01

To compare the ocular comfort and tolerability of loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T; Zylet) with dexamethasone 0.1%/tobramycin 0.3% (DM/T; TobraDex) in healthy volunteers. In this multicenter, randomized, double-masked, parallel-group study, healthy volunteers (n = 306) were randomized to receive LE/T or DM/T four times per day for 28 days. Subjects recorded subjective ratings for seven comfort/tolerability parameters using an electronic patient diary (EPD). The primary endpoint was the difference at week 4 from the ratings of an artificial tear at baseline in comfort/tolerability parameters between treatment groups, using a noninferiority paradigm. ClinicalTrials. gov, NCT 00532961. The 97.5% confidence intervals for the lower bound were within -10 for all of the seven comfort/ tolerability parameters evaluated (pain, stinging/burning, irritation, itchiness, foreign-body sensation, dryness, and light sensitivity). Secondary analysis revealed small but significant within-treatment differences in pain favoring LE/T over tears and in light sensitivity favoring tears over DM/T (p < 0.01). Small between-treatment differences in the changes from baseline tear ratings to individual study visits favored LE/T for pain, stinging/burning, irritation, itchiness, foreign-body sensation, and light sensitivity at visit 4 (p < or = 0.04); for pain, stinging/burning, and foreignbody sensation at visit 5 (p < or = 0.03), and for dryness and light sensitivity at visit 6 (p < or = 0.05). LE/T satisfied all conditions of noninferiority to DM/T in comfort and tolerability. Subjects receiving LE/T were more likely to report better ocular comfort/tolerability ratings relative to baseline artificial tears than subjects receiving DM/T. The study population consisted of healthy volunteers.

Oronasal mask may compromise the efficacy of continuous positive airway pressure on OSA treatment: is there evidence for avoiding the oronasal route?

PubMed

Andrade, Rafaela Garcia Santos; Madeiro, Fernanda; Genta, Pedro Rodrigues; Lorenzi-Filho, Geraldo

2016-11-01

Continuous positive airway pressure (CPAP) delivered by nasal mask is the gold standard treatment for obstructive sleep apnea (OSA). However, oral and oronasal masks are also available. We considered experimental evidence and reviewed clinical trials that evaluated the impact of oral and oronasal mask on OSA treatment. One recent study in 18 OSA patients that slept with a customized oronasal mask with two sealed compartments showed that the change of CPAP flow from nasal to oronasal and oral caused upper airway obstruction because of posterior displacement of the tongue demonstrated by nasoendoscopy. Oral masks use a mouthpiece that may stabilize the jaw and the tongue and have shown to be effective. However, oral masks are not widely used in clinical practice. Four out of five observational studies and all five reviewed randomized studies showed a worse performance of oronasal when compared with nasal masks. Oronasal masks were associated with higher residual apnea-hypopnea index, lower adherence, more leaks, and less satisfaction than nasal mask in the majority of the studies. Nasal CPAP must be the first choice to treat OSA. Patients on oronasal mask should be carefully followed. VIDEO ABSTRACT.

Comparison of Ventilation With One-Handed Mask Seal With an Intraoral Mask Versus Conventional Cuffed Face Mask in a Cadaver Model: A Randomized Crossover Trial.

PubMed

Amack, Andrew J; Barber, Gary A; Ng, Patrick C; Smith, Thomas B; April, Michael D

2017-01-01

We compare received minute volume with an intraoral mask versus conventional cuffed face mask among medics obtaining a 1-handed mask seal on a cadaver model. This study comprised a randomized crossover trial of adult US Army combat medic volunteers participating in a cadaver laboratory as part of their training. We randomized participants to obtain a 1-handed mask seal during ventilation of a fresh unembalmed cadaver, first using either an intraoral airway device or conventional cuffed face mask. Participants obtained a 1-handed mask seal while a ventilator delivered 10 standardized 750-mL breaths during 1 minute. After a 5-minute rest period, they repeated the study with the alternative mask. The primary outcome measure was received minute volume as measured by a respirometer. Of 27 recruited participants, all completed the study. Median received minute volume was higher with the intraoral mask compared with conventional cuffed mask by 1.7 L (95% confidence interval 1.0 to 1.9 L; P<.001). The intraoral mask resulted in greater received minute volume received compared with conventional cuffed face mask during ventilation with a 1-handed mask seal in a cadaver model. The intraoral mask may prove a useful airway adjunct for ventilation. Copyright © 2016 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

Flavored Anesthetic Masks for Inhalational Induction in Children.

PubMed

Gupta, Aakriti; Mathew, Preethy Joseph; Bhardwaj, Neerja

2017-10-01

To evaluate the clinical efficacy of masking the odor of inhalational agents using fruit flavors on the anxiety behavior and compliance of children for inhalational induction. A prospective randomized double blind, placebo controlled study was conducted on 60 unpremedicated children in the age group of 4-12 y. Thirty children received anesthetic masks smeared with a flavor of child's choice while the other 30 children were induced using masks without flavor. Anxiety was assessed using modified Yale Pre-operative Anxiety Scale (mYPAS) in the pre-op room and during inhalational induction. Mask acceptance was graded by Induction Compliance Checklist (ICC). The cost-effectiveness of flavored anesthetic masks was compared to that of commercially available pre-scented masks. The baseline anxiety in the two groups was comparable. The number of children demonstrating high levels of anxiety at anesthetic induction was similar in flavored and non-flavored mask groups (p 0.45). The compliance to mask induction was also equally good (p 0.99). The authors found significant difference in the cost of flavored mask (INR 56.45 per mask) as compared to commercially available pre-scented masks (INR 660 per mask). The authors observed a placebo effect that reduced the pre-op anxiety in the control group which probably made the quality of induction equivalent with flavored and non-flavored masks. Therefore, using a flavored anesthetic mask is cost-effective than using a commercially available pre-scented mask.

Tinnitus retraining therapy: mixing point and total masking are equally effective.

PubMed

Tyler, Richard S; Noble, William; Coelho, Claudia Barros; Ji, Haihong

2012-01-01

Habituation to tinnitus cannot occur with total masking, an argument made by proponents of "tinnitus retraining therapy." We also compared the effectiveness of retraining therapy with mixing-point masking, total masking, and with counseling alone. Forty-eight tinnitus patients were randomly assigned to one of three groups: counseling, counseling plus bilateral noise generators set to completely mask the tinnitus, or counseling plus bilateral noise generators with a focus on the mixing point (partial masking just below total masking). A picture-based counseling protocol was used to assist in providing similar counseling among all three groups. The Tinnitus Handicap Questionnaire was administered before and after about 12 months of treatment. After 12 months, in the counseling group, three of 18 patients benefited significantly, in the mixing-point group, six of 19 patients benefited, and in the total masking group, four of 11 patients benefited from the treatment. The average decrease in the questionnaire was 16.7% for the counseling group, 31.6% for the retraining group, and 36.4% for the total masking group. No significant average differences among groups were observed. One premise of retraining therapy is incorrect; a focus on mixing-point masking is not required for habituation.

A Randomized Trial Comparing Part-time Patching with Observation for Children 3–10 Years Old with Intermittent Exotropia

PubMed Central

Cotter, Susan A.; Mohney, Brian G.; Chandler, Danielle L.; Holmes, Jonathan M.; Repka, Michael X.; Melia, Michele; Wallace, David K.; Beck, Roy W.; Birch, Eileen E.; Kraker, Raymond T.; Tamkins, Susanna M.; Miller, Aaron M.; Sala, Nicholas A.; Glaser, Stephen R.

2014-01-01

Objective To determine the effectiveness of prescribed part-time patching for treatment of intermittent exotropia in children Design Multicenter, randomized clinical trial Participants Three hundred fifty-eight children aged 3 to < 11 years old with previously untreated (except for refractive correction) intermittent exotropia (IXT) and near stereoacuity of 400 arcsec or better were enrolled. Intermittent exotropia met the following criteria: 1) constant or intermittent exotropia at distance and either intermittent exotropia or exophoria at near; 2) exodeviation (tropia or phoria) of at least 15 prism diopters (Δ) at distance or near by prism and alternate cover test (PACT); and 3) exodeviation of at least 10Δ at distance by PACT. Methods Participants were randomly assigned to either observation (no treatment for 6 months) or patching for 3 hours per day for 5 months, with a 1-month washout period of no patching before the 6-month primary outcome exam. Main Outcome Measure The primary outcome was deterioration at either the 3-month or the 6-month follow-up visit, defined as: 1) constant exotropia measuring at least 10Δ at distance and near by simultaneous prism and cover test, and/or 2) near stereoacuity decreased by at least 2 octaves from baseline, both assessed by a masked examiner and confirmed by a retest. Participants who were prescribed any non-randomized treatment without first meeting either deterioration criteria were also counted as having deteriorated. Results Of the 324 (91%) participants completing the 6-month primary outcome exam, deterioration occurred in 10 (6.1%) of the 165 participants in the observation group (3 of these 10 started treatment without meeting deterioration criteria) and in 1 (0.6%) of the 159 participants in the part-time patching group (difference = 5.4%, lower limit of one-sided exact 95% confidence interval = 2.0%; p value from one-sided hypothesis test = 0.004). Conclusion Deterioration of previously untreated childhood IXT over a 6-month period is uncommon with or without patching treatment. Although there is a slightly lower deterioration rate with patching, both management approaches are reasonable for treating 3 to 10 year olds with IXT. PMID:25234012

Clinical Outcomes of Fixed Versus As-Needed Use of Artificial Tears in Dry Eye Disease: A 6-Week, Observer-Masked Phase 4 Clinical Trial.

PubMed

Asbell, Penny; Vingrys, Algis J; Tan, Jacqueline; Ogundele, Abayomi; Downie, Laura E; Jerkins, Gary; Shettle, Lee

2018-05-01

To evaluate the clinical effects of using fixed (four times daily [QID]) versus as-needed (PRN) dosing of an artificial tear product (polyethylene glycol/propylene glycol [PEG/PG]; Systane Ultra) in individuals with dry eye disease. In this prospective, multicenter, observer-masked, active-control, parallel-group trial, participants were randomized (1:2 allocation) to receive 1 drop of PEG/PG QID (n = 34) or PRN (n = 63) for 28 days. The primary endpoint was change from baseline in the total ocular surface staining (TOSS) score (according to the Oxford scale) at day 28. At day 28, the change from baseline in least squares mean (LSM) TOSS scores for QID and PRN groups were -1.19 and -0.94, respectively (treatment difference [TD]: -0.26; 95% confidence interval [CI]: -∞ to 0.21; P = 0.184); superiority of QID versus PRN dosing was not established, as the upper limit of one-sided 95% CI for TD was not <0 (prespecified limit). At day 28, for QID and PRN groups, the LSM change from baseline in Impact of Dry Eye on Everyday Life (IDEEL) scores was symptom-bother, -7.0 and -2.94 (TD: -4.06, P = 0.037); treatment effectiveness, 2.43 and 0.16 (TD: 2.28, P = 0.278); and treatment-related inconvenience, -11.56 and -2.77 (TD: -8.8, P = 0.996), respectively. Incidence of adverse events was low (≤3.2%) in both the groups; no serious adverse events were reported. QID dosing of PEG/PG was not superior to PRN dosing in terms of ocular staining. The IDEEL symptom-bother score favored QID dosing, suggesting that regular use of artificial tears may provide better symptomatic relief than PRN use. (ClinicalTrials.gov number, NCT02446015.).

Besifloxacin ophthalmic suspension 0.6% in patients with bacterial conjunctivitis: A multicenter, prospective, randomized, double-masked, vehicle-controlled, 5-day efficacy and safety study.

PubMed

Karpecki, Paul; Depaolis, Michael; Hunter, Judy A; White, Eric M; Rigel, Lee; Brunner, Lynne S; Usner, Dale W; Paterno, Michael R; Comstock, Timothy L

2009-03-01

Besifloxacin ophthalmic suspension 0.6% is a new topical fluoroquinolone for the treatment of bacterial conjunctivitis. Besifloxacin has potent in vitro activity against a broad spectrum of ocular pathogens, including drug-resistant strains. The primary objective of this study was to compare the clinical and microbiologic efficacy of besifloxacin ophthalmic suspension 0.6% with that of vehicle (the formulation without besifloxacin) in the treatment of bacterial conjunctivitis. This was a multicenter, prospective, randomized, double-masked, vehicle-controlled, parallel-group study in patients with acute bacterial conjunctivitis. Patients received either topical besifloxacin ophthalmic suspension or vehicle administered 3 times daily for 5 days. At study entry and on days 4 and 8 (visits 2 and 3), a clinical assessment of ocular signs and symptoms was performed in both eyes, as well as pinhole visual acuity testing, biomicroscopy, and culture of the infected eye(s). An ophthalmoscopic examination was performed at study entry and on day 8. The primary efficacy outcome measures were clinical resolution and eradication of the baseline bacterial infection on day 8 in culture-confirmed patients. The safety evaluation included adverse events, changes in visual acuity, and biomicroscopy and ophthalmoscopy findings in all patients who received at least 1 dose of active treatment or vehicle. The safety population consisted of 269 patients (mean [SD] age, 34.2 [22.3] years; 60.2% female; 82.5% white) with acute bacterial conjunctivitis. The culture-confirmed intent-to-treat population consisted of 118 patients (60 besifloxacin ophthalmic suspension, 58 vehicle). Significantly more patients receiving besifloxacin ophthalmic suspension than vehicle had clinical resolution of the baseline infection at visit 3 (44/60 [73.3%] vs 25/58 [43.1%], respectively; P < 0.001). Rates of bacterial eradication also were significantly greater with besifloxacin ophthalmic suspension compared with vehicle at visit 3 (53/60 [88.3%] vs35/58 [60.3%]; P < 0.001). The cumulative frequency of adverse events did not differ significantly between the 2 groups (69/137 [50.4%] and 70/132 [53.0%]). The most common ocular adverse events were eye pain (20/190 treated eyes [10.5%] and 13/188 [6.9%]), blurred vision (20/190 [10.5%] and 22/188 [11.7%]), and eye irritation (14/190 [7.4%] and 23/188 [12.2%]); these events were of mild or moderate severity. Changes in visual acuity and treatment-emergent events observed on biomicroscopy and direct ophthalmoscopy also were comparable between treatment groups. Besifloxacin ophthalmic suspension 0.6% given 3 times daily for 5 days was both efficacious and well tolerated compared with vehicle in the treatment of these patients with bacterial conjunctivitis. ClinicalTrials.gov Identifier: NCT00622908.

Mask ventilation with two different face masks in the delivery room for preterm infants: a randomized controlled trial.

PubMed

Cheung, D; Mian, Q; Cheung, P-Y; O'Reilly, M; Aziz, K; van Os, S; Pichler, G; Schmölzer, G M

2015-07-01

If an infant fails to initiate spontaneous breathing after birth, international guidelines recommend a positive pressure ventilation (PPV). However, PPV by face mask is frequently inadequate because of leak between the face and mask. Despite a variety of available face masks, none have been prospectively compared in a randomized fashion. We aimed to evaluate and compare leak between two commercially available round face masks (Fisher & Paykel (F&P) and Laerdal) in preterm infants <33 weeks gestational age in the delivery room. Infants born at the Royal Alexandra Hospital from April to September 2013 at <33 weeks gestational age who received mask PPV in the delivery room routinely had a flow sensor placed between the mask and T-piece resuscitator. Infants were randomly assigned to receive PPV with either a F&P or Laerdal face mask. All resuscitators were trained in the use of both face masks. We compared mask leak, airway pressures, tidal volume and ventilation rate between the two groups. Fifty-six preterm infants (n=28 in each group) were enrolled; mean±s.d. gestational age 28±3 weeks; birth weight 1210±448 g; and 30 (52%) were male. Apgar scores at 1 and 5 min were 5±3 and 7±2, respectively. Infants randomized to the F&P face mask and Laerdal face mask had similar mask leak (30 (25-38) versus 35 (24-46)%, median (interquartile range), respectively, P=0.40) and tidal volume (7.1 (4.9-8.9) versus 6.6 (5.2-8.9) ml kg(-1), P=0.69) during PPV. There were no significant differences in ventilation rate, inflation time or airway pressures between groups. The use of either face mask during PPV in the delivery room yields similar mask leak in preterm infants <33 weeks gestational age.

Recipient Risk Factors for Graft Failure in the Cornea Donor Study

PubMed Central

Sugar, Alan; Tanner, Jean Paul; Dontchev, Mariya; Tennant, Brad; Schultze, Robert L.; Dunn, Steven P.; Lindquist, Thomas D.; Gal, Robin L.; Beck, Roy W.; Kollman, Craig; Mannis, Mark J.; Holland, Edward J.

2009-01-01

Purpose Identify recipient factors which may be related to risk of corneal graft failure Design Multi-center prospective, double-masked, controlled clinical trial Participants 1090 subjects undergoing corneal transplantation for a moderate risk condition (principally Fuchs’ dystrophy or pseudophakic corneal edema) Methods Donor corneas were assigned using a random approach without respect to recipient factors, and surgeons were masked to information about the donor cornea including donor age. Surgery and post-operative care were performed according to the surgeons’ usual routines and subjects were followed for five years. Baseline factors were evaluated for their association with graft failure. Main Outcome Measures Graft failure, defined as a regraft or a cloudy cornea that was sufficiently opaque to compromise vision for a minimum of three consecutive months. Results Preoperative diagnosis of pseudophakic/aphakic corneal edema increased graft failure risk approximately 4-fold compared with Fuchs’ dystrophy (27% vs. 7%). Prior glaucoma surgery with preoperative glaucoma medication use substantially increased the graft failure rate. Factors not strongly associated with graft failure included age, gender, diabetes, smoking, and graft size. Conclusion The risk of graft failure is significantly increased in eyes with pseudophakic or aphakic corneal edema compared with Fuchs’ dystrophy, independent of lens status, and in eyes with a history of glaucoma. PMID:19395036

Phase 2 Randomized, Double-Masked, Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis.

PubMed

Bonini, Stefano; Lambiase, Alessandro; Rama, Paolo; Sinigaglia, Francesco; Allegretti, Marcello; Chao, Wendy; Mantelli, Flavio

2018-04-10

To evaluate the safety and efficacy of topical recombinant human nerve growth factor (rhNGF) for treating moderate-to-severe neurotrophic keratitis (NK), a rare degenerative corneal disease resulting from impaired corneal innervation. Phase 2 multicenter, randomized, double-masked, vehicle-controlled trial. Patients with stage 2 (moderate) or stage 3 (severe) NK in 1 eye. The REPARO phase 2 study assessed safety and efficacy in 156 patients randomized 1:1:1 to rhNGF 10 μg/ml, 20 μg/ml, or vehicle. Treatment was administered 6 drops per day for 8 weeks. Patients then entered a 48- or 56-week follow-up period. Safety was assessed in all patients who received study treatment, whereas efficacy was by intention to treat. Corneal healing (defined as <0.5-mm maximum diameter of fluorescein staining in the lesion area) was assessed by masked central readers at week 4 (primary efficacy end point) and week 8 (key secondary end point) of controlled treatment. Corneal healing was reassessed post hoc by masked central readers using a more conservative measure (0-mm staining in the lesion area and no other persistent staining). At week 4 (primary end point), 19.6% of vehicle-treated patients achieved corneal healing (<0.5-mm lesion staining) versus 54.9% receiving rhNGF 10 μg/ml (+35.3%; 97.06% confidence interval [CI], 15.88-54.71; P < 0.001) and 58.0% receiving rhNGF 20 μg/ml (+38.4%; 97.06% CI, 18.96-57.83; P < 0.001). At week 8 (key secondary end point), 43.1% of vehicle-treated patients achieved less than 0.5-mm lesion staining versus 74.5% receiving rhNGF 10 μg/ml (+31.4%; 97.06% CI, 11.25-51.49; P = 0.001) and 74.0% receiving rhNGF 20 μg/ml (+30.9%; 97.06% CI, 10.60-51.13; P = 0.002). Post hoc analysis of corneal healing by the more conservative measure (0-mm lesion staining and no other persistent staining) maintained statistically significant differences between rhNGF and vehicle at weeks 4 and 8. More than 96% of patients who healed after controlled rhNGF treatment remained recurrence free during follow-up. Treatment with rhNGF was well tolerated; adverse effects were mostly local, mild, and transient. Topical rhNGF is safe and more effective than vehicle in promoting healing of moderate-to-severe NK. Copyright © 2018 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Corticosteroids for Bacterial Keratitis

PubMed Central

Srinivasan, Muthiah; Mascarenhas, Jeena; Rajaraman, Revathi; Ravindran, Meenakshi; Lalitha, Prajna; Glidden, David V.; Ray, Kathryn J.; Hong, Kevin C.; Oldenburg, Catherine E.; Lee, Salena M.; Zegans, Michael E.; McLeod, Stephen D.; Lietman, Thomas M.; Acharya, Nisha R.

2013-01-01

Objective To determine whether there is a benefit in clinical outcomes with the use of topical corticosteroids as adjunctive therapy in the treatment of bacterial corneal ulcers. Methods Randomized, placebo-controlled, double-masked, multicenter clinical trial comparing prednisolone sodium phosphate, 1.0%, to placebo as adjunctive therapy for the treatment of bacterial corneal ulcers. Eligible patients had a culture-positive bacterial corneal ulcer and received topical moxifloxacin for at least 48 hours before randomization. Main Outcome Measures The primary outcome was best spectacle-corrected visual acuity (BSCVA) at 3 months from enrollment. Secondary outcomes included infiltrate/scar size, reepithelialization, and corneal perforation. Results Between September 1, 2006, and February 22, 2010, 1769 patients were screened for the trial and 500 patients were enrolled. No significant difference was observed in the 3-month BSCVA (−0.009 logarithm of the minimum angle of resolution [logMAR]; 95% CI, −0.085 to 0.068; P = .82), infiltrate/scar size (P = .40), time to reepithelialization (P = .44), or corneal perforation (P > .99). A significant effect of corticosteroids was observed in subgroups of baseline BSCVA (P = .03) and ulcer location (P = .04). At 3 months, patients with vision of counting fingers or worse at baseline had 0.17 logMAR better visual acuity with corticosteroids (95% CI, −0.31 to −0.02; P = .03) compared with placebo, and patients with ulcers that were completely central at baseline had 0.20 logMAR better visual acuity with corticosteroids (−0.37 to −0.04; P = .02). Conclusions We found no overall difference in 3-month BSCVA and no safety concerns with adjunctive corticosteroid therapy for bacterial corneal ulcers. Application to Clinical Practice Adjunctive topical corticosteroid use does not improve 3-month vision in patients with bacterial corneal ulcers. PMID:21987582

Corticosteroids for bacterial keratitis: the Steroids for Corneal Ulcers Trial (SCUT).

PubMed

Srinivasan, Muthiah; Mascarenhas, Jeena; Rajaraman, Revathi; Ravindran, Meenakshi; Lalitha, Prajna; Glidden, David V; Ray, Kathryn J; Hong, Kevin C; Oldenburg, Catherine E; Lee, Salena M; Zegans, Michael E; McLeod, Stephen D; Lietman, Thomas M; Acharya, Nisha R

2012-02-01

To determine whether there is a benefit in clinical outcomes with the use of topical corticosteroids as adjunctive therapy in the treatment of bacterial corneal ulcers. Randomized, placebo-controlled, double-masked, multicenter clinical trial comparing prednisolone sodium phosphate, 1.0%, to placebo as adjunctive therapy for the treatment of bacterial corneal ulcers. Eligible patients had a culture-positive bacterial corneal ulcer and received topical moxifloxacin for at least 48 hours before randomization. The primary outcome was best spectacle-corrected visual acuity (BSCVA) at 3 months from enrollment. Secondary outcomes included infiltrate/scar size, reepithelialization, and corneal perforation. Between September 1, 2006, and February 22, 2010, 1769 patients were screened for the trial and 500 patients were enrolled. No significant difference was observed in the 3-month BSCVA (-0.009 logarithm of the minimum angle of resolution [logMAR]; 95% CI, -0.085 to 0.068; P = .82), infiltrate/scar size (P = .40), time to reepithelialization (P = .44), or corneal perforation (P > .99). A significant effect of corticosteroids was observed in subgroups of baseline BSCVA (P = .03) and ulcer location (P = .04). At 3 months, patients with vision of counting fingers or worse at baseline had 0.17 logMAR better visual acuity with corticosteroids (95% CI, -0.31 to -0.02; P = .03) compared with placebo, and patients with ulcers that were completely central at baseline had 0.20 logMAR better visual acuity with corticosteroids (-0.37 to -0.04; P = .02). We found no overall difference in 3-month BSCVA and no safety concerns with adjunctive corticosteroid therapy for bacterial corneal ulcers. Adjunctive topical corticosteroid use does not improve 3-month vision in patients with bacterial corneal ulcers. clinicaltrials.gov Identifier: NCT00324168.

Clinical Efficacy and Safety of Ranibizumab Versus Dexamethasone for Central Retinal Vein Occlusion (COMRADE C): A European Label Study.

PubMed

Hoerauf, Hans; Feltgen, Nicolas; Weiss, Claudia; Paulus, Eva-Maria; Schmitz-Valckenberg, Steffen; Pielen, Amelie; Puri, Pankaj; Berk, Hüsnü; Eter, Nicole; Wiedemann, Peter; Lang, Gabriele E; Rehak, Matus; Wolf, Armin; Bertelmann, Thomas; Hattenbach, Lars-Olof

2016-09-01

To compare the efficacy and safety of the European labels of ranibizumab 0.5 mg vs dexamethasone 0.7 mg in patients with macular edema secondary to central retinal vein occlusion (CRVO). Phase IIIb, multicenter, double-masked, randomized clinical trial. Patients were randomized (1:1) to receive either monthly ranibizumab followed by pro re nata (PRN) treatment (n = 124) or 1 sustained-release dexamethasone implant followed by PRN sham injections (n = 119). Main outcomes were mean average change in best-corrected visual acuity (BCVA) from baseline to month 1 through month 6, mean change in BCVA, and adverse events (AEs). Of 243 patients, 185 (76.1%) completed the study. No difference was observed in BCVA between ranibizumab and dexamethasone at months 1 and 2. From month 3 to month 6, there was significant difference in BCVA gains in favor of ranibizumab. At month 6, mean average BCVA gain was significantly higher with ranibizumab than with dexamethasone (12.86 vs 2.96 letters; difference 9.91 letters, 95% confidence interval [6.51-13.30]; P < .0001). Mean injection number of ranibizumab was 4.52. Ocular AEs were reported in more patients in the dexamethasone than in the ranibizumab group (86.6% vs 55.6%). Using the European labels, similar efficacy was observed for ranibizumab and dexamethasone at months 1 and 2. However, ranibizumab maintained its efficacy throughout the study, whereas dexamethasone declined from month 3 onward. The main limitation of the study was that dexamethasone patients received only a single treatment during the 6-month study. In clinical practice, dexamethasone retreatment may be required earlier than 6 months. Safety findings were similar to those previously reported. Copyright © 2016 Elsevier Inc. All rights reserved.

Enhancement in Informational Masking

ERIC Educational Resources Information Center

Cao, Xiang; Richards, Virginia M.

2012-01-01

Purpose: The ability to detect a tone added to a random masker improves when a preview of the masker is provided. In 2 experiments, the authors explored the role that perceptual organization plays in this release from masking. Method: Detection thresholds were measured in informational masking studies. The maskers were drawn at random prior to…

The Dirichlet-Multinomial Model for Multivariate Randomized Response Data and Small Samples

ERIC Educational Resources Information Center

Avetisyan, Marianna; Fox, Jean-Paul

2012-01-01

In survey sampling the randomized response (RR) technique can be used to obtain truthful answers to sensitive questions. Although the individual answers are masked due to the RR technique, individual (sensitive) response rates can be estimated when observing multivariate response data. The beta-binomial model for binary RR data will be generalized…

Randomized, Controlled, Phase 2 Trial of Povidone-Iodine/Dexamethasone Ophthalmic Suspension for Treatment of Adenoviral Conjunctivitis.

PubMed

Pepose, Jay S; Ahuja, Arjun; Liu, Wenlei; Narvekar, Abhijit; Haque, Reza

2018-05-19

To evaluate the efficacy/safety of an ophthalmic suspension of povidone-iodine (PVP-I) 0.6% and dexamethasone 0.1% in patients with acute adenoviral conjunctivitis. Multicenter, randomized, vehicle-controlled, double-masked trial. Adults with a positive Rapid Pathogen Screening Adeno-Detector Plus TM test were randomized 1:1:1 to PVP-I 0.6%/dexamethasone 0.1%, PVP-I 0.6%, or vehicle, bilaterally 4 times daily for 5 days (days 1-5). Patients were evaluated on days 3, 6, and 12 (+1-day window). Efficacy measures included clinical resolution and adenoviral eradication. Overall, 144 patients were included in the efficacy analysis (PVP-I/dexamethasone, n = 48; PVP-I, n = 50; vehicle, n = 46). The proportion of patients with clinical resolution (primary study eye with last observation carried forward [LOCF]) at the day 6 visit was higher with PVP-I/dexamethasone (31.3%) than vehicle (10.9%; P = .0158) and PVP-I (18.0%; P = nonsignificant). The proportion with adenoviral eradication (primary study eye with LOCF) was higher with PVP-I/dexamethasone than vehicle at the day 3 (35.4% vs 8.7%; P = .0019) and day 6 (79.2% vs 56.5%; P = .0186) visits and versus PVP-I (day 3 visit, 32.0%; day 6 visit, 62.0%; each P = nonsignificant). Treatment-emergent adverse events (AEs) occurred in 69.0% (vehicle), 62.7% (PVP-I), and 53.4% (PVP-I/dexamethasone) of patients in the safety dataset. Discontinuation owing to AEs occurred in 37 patients (vehicle, n = 16; PVP-I, n = 12; PVP-I/dexamethasone, n = 9). PVP-I/dexamethasone appeared safe and well tolerated, and significantly improved clinical resolution and adenoviral eradication in patients with acute adenoviral conjunctivitis. Copyright © 2018. Published by Elsevier Inc.

Influence of face mask design on bag-valve-mask ventilation performance: a randomized simulation study.

PubMed

Na, J U; Han, S K; Choi, P C; Cho, J H; Shin, D H

2013-10-01

Different face mask designs can influence bag-valve-mask (BVM) ventilation performance during resuscitation. We compared a single-use, air-cushioned face mask (AM) with a reusable silicone face mask (SM) for quality of BVM ventilation on a manikin simulating cardiac arrest. Thirty-two physicians were recruited, and a prospective, randomized, crossover observational study was conducted after an American Heart Association-accredited basic life support provider course and standardized practice time were completed. Participants performed 12 cycles of BVM ventilation with both the AM and SM on a SmartMan lung simulator. Mean tidal volume was significantly higher in ventilations performed using the AM vs. the SM (548 ± 159 ml vs. 439 ± 163 ml, P < 0.01). In addition, the proportion of low-volume ventilation was significantly lower with the AM than the SM [6/12 (2-11) vs. 9/12 (5-12), P = 0.03]. Bag-valve-AM ventilation volume was not affected by the physical characteristics of the rescuers, except for sex. In contrast, bag-valve-SM ventilation volume was affected by most of the characteristics tested, including sex, height, weight, hand width, hand length, and grip power. The AM seems to be a more efficient face mask than the SM at delivering sufficient ventilation volumes. The performance of the AM did not seem to be associated with the physical characteristics of the rescuers, whereas that of the SM was affected by these factors. The SM may not be an appropriate face mask for performing one-person BVM ventilation during resuscitation for rescuers who are smaller in stature, have a smaller hand size, or have weaker grip power. © 2013 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

Validation of optical codes based on 3D nanostructures

NASA Astrophysics Data System (ADS)

Carnicer, Artur; Javidi, Bahram

2017-05-01

Image information encoding using random phase masks produce speckle-like noise distributions when the sample is propagated in the Fresnel domain. As a result, information cannot be accessed by simple visual inspection. Phase masks can be easily implemented in practice by attaching cello-tape to the plain-text message. Conventional 2D-phase masks can be generalized to 3D by combining glass and diffusers resulting in a more complex, physical unclonable function. In this communication, we model the behavior of a 3D phase mask using a simple approach: light is propagated trough glass using the angular spectrum of plane waves whereas the diffusor is described as a random phase mask and a blurring effect on the amplitude of the propagated wave. Using different designs for the 3D phase mask and multiple samples, we demonstrate that classification is possible using the k-nearest neighbors and random forests machine learning algorithms.

Hormonal regulators of muscle and metabolism in aging (HORMA): Design and conduct of a complex, double-masked, multicenter trial

USDA-ARS?s Scientific Manuscript database

BACKGROUND: Older persons often lose muscle mass, strength, and physical function. This report describes the challenges of conducting a complex clinical investigation assessing the effects of anabolic hormones on body composition, physical function, and metabolism during aging. METHODS: HORMA is a m...

Incidence, predictors, and outcome of difficult mask ventilation combined with difficult laryngoscopy: a report from the multicenter perioperative outcomes group.

PubMed

Kheterpal, Sachin; Healy, David; Aziz, Michael F; Shanks, Amy M; Freundlich, Robert E; Linton, Fiona; Martin, Lizabeth D; Linton, Jonathan; Epps, Jerry L; Fernandez-Bustamante, Ana; Jameson, Leslie C; Tremper, Tyler; Tremper, Kevin K

2013-12-01

Research regarding difficult mask ventilation (DMV) combined with difficult laryngoscopy (DL) is extremely limited even though each technique serves as a rescue for one another. Four tertiary care centers participating in the Multicenter Perioperative Outcomes Group used a consistent structured patient history and airway examination and airway outcome definition. DMV was defined as grade 3 or 4 mask ventilation, and DL was defined as grade 3 or 4 laryngoscopic view or four or more intubation attempts. The primary outcome was DMV combined with DL. Patients with the primary outcome were compared to those without the primary outcome to identify predictors of DMV combined with DL using a non-parsimonious logistic regression. Of 492,239 cases performed at four institutions among adult patients, 176,679 included a documented face mask ventilation and laryngoscopy attempt. Six hundred ninety-eight patients experienced the primary outcome, an overall incidence of 0.40%. One patient required an emergent cricothyrotomy, 177 were intubated using direct laryngoscopy, 284 using direct laryngoscopy with bougie introducer, 163 using videolaryngoscopy, and 73 using other techniques. Independent predictors of the primary outcome included age 46 yr or more, body mass index 30 or more, male sex, Mallampati III or IV, neck mass or radiation, limited thyromental distance, sleep apnea, presence of teeth, beard, thick neck, limited cervical spine mobility, and limited jaw protrusion (c-statistic 0.84 [95% CI, 0.82-0.87]). DMV combined with DL is an infrequent but not rare phenomenon. Most patients can be managed with the use of direct or videolaryngoscopy. An easy to use unweighted risk scale has robust discriminating capacity.

Overlay improvement by exposure map based mask registration optimization

NASA Astrophysics Data System (ADS)

Shi, Irene; Guo, Eric; Chen, Ming; Lu, Max; Li, Gordon; Li, Rivan; Tian, Eric

2015-03-01

Along with the increased miniaturization of semiconductor electronic devices, the design rules of advanced semiconductor devices shrink dramatically. [1] One of the main challenges of lithography step is the layer-to-layer overlay control. Furthermore, DPT (Double Patterning Technology) has been adapted for the advanced technology node like 28nm and 14nm, corresponding overlay budget becomes even tighter. [2][3] After the in-die mask registration (pattern placement) measurement is introduced, with the model analysis of a KLA SOV (sources of variation) tool, it's observed that registration difference between masks is a significant error source of wafer layer-to-layer overlay at 28nm process. [4][5] Mask registration optimization would highly improve wafer overlay performance accordingly. It was reported that a laser based registration control (RegC) process could be applied after the pattern generation or after pellicle mounting and allowed fine tuning of the mask registration. [6] In this paper we propose a novel method of mask registration correction, which can be applied before mask writing based on mask exposure map, considering the factors of mask chip layout, writing sequence, and pattern density distribution. Our experiment data show if pattern density on the mask keeps at a low level, in-die mask registration residue error in 3sigma could be always under 5nm whatever blank type and related writer POSCOR (position correction) file was applied; it proves random error induced by material or equipment would occupy relatively fixed error budget as an error source of mask registration. On the real production, comparing the mask registration difference through critical production layers, it could be revealed that registration residue error of line space layers with higher pattern density is always much larger than the one of contact hole layers with lower pattern density. Additionally, the mask registration difference between layers with similar pattern density could also achieve under 5nm performance. We assume mask registration excluding random error is mostly induced by charge accumulation during mask writing, which may be calculated from surrounding exposed pattern density. Multi-loading test mask registration result shows that with x direction writing sequence, mask registration behavior in x direction is mainly related to sequence direction, but mask registration in y direction would be highly impacted by pattern density distribution map. It proves part of mask registration error is due to charge issue from nearby environment. If exposure sequence is chip by chip for normal multi chip layout case, mask registration of both x and y direction would be impacted analogously, which has also been proved by real data. Therefore, we try to set up a simple model to predict the mask registration error based on mask exposure map, and correct it with the given POSCOR (position correction) file for advanced mask writing if needed.

Failure to preserve beta-cell function with mycophenolate mofetil and daclizumab combined therapy in patients with new- onset type 1 diabetes.

PubMed

Gottlieb, Peter A; Quinlan, Scott; Krause-Steinrauf, Heidi; Greenbaum, Carla J; Wilson, Darrell M; Rodriguez, Henry; Schatz, Desmond A; Moran, Antoinette M; Lachin, John M; Skyler, Jay S

2010-04-01

This trial tested whether mycophenolate mofetil (MMF) alone or with daclizumab (DZB) could arrest the loss of insulin-producing beta-cells in subjects with new-onset type 1 diabetes. A multi-center, randomized, placebo-controlled, double-masked trial was initiated by Type 1 Diabetes TrialNet at 13 sites in North America and Europe. Subjects diagnosed with type 1 diabetes and with sufficient C-peptide within 3 months of diagnosis were randomized to either MMF alone, MMF plus DZB, or placebo, and then followed for 2 years. The primary outcome was the geometric mean area under the curve (AUC) C-peptide from the 2-h mixed meal tolerance test. One hundred and twenty-six subjects were randomized and treated during the trial. The geometric mean C-peptide AUC at 2 years was unaffected by MMF alone or MMF plus DZB versus placebo. Adverse events were more frequent in the active therapy groups relative to the control group, but not significantly. Neither MMF alone nor MMF in combination with DZB had an effect on the loss of C-peptide in subjects with new-onset type 1 diabetes. Higher doses or more targeted immunotherapies may be needed to affect the autoimmune process.

Failure to Preserve β-Cell Function With Mycophenolate Mofetil and Daclizumab Combined Therapy in Patients With New- Onset Type 1 Diabetes

PubMed Central

Gottlieb, Peter A.; Quinlan, Scott; Krause-Steinrauf, Heidi; Greenbaum, Carla J.; Wilson, Darrell M.; Rodriguez, Henry; Schatz, Desmond A.; Moran, Antoinette M.; Lachin, John M.; Skyler, Jay S.

2010-01-01

OBJECTIVE This trial tested whether mycophenolate mofetil (MMF) alone or with daclizumab (DZB) could arrest the loss of insulin-producing β-cells in subjects with new-onset type 1 diabetes. RESEARCH DESIGN AND METHODS A multi-center, randomized, placebo-controlled, double-masked trial was initiated by Type 1 Diabetes TrialNet at 13 sites in North America and Europe. Subjects diagnosed with type 1 diabetes and with sufficient C-peptide within 3 months of diagnosis were randomized to either MMF alone, MMF plus DZB, or placebo, and then followed for 2 years. The primary outcome was the geometric mean area under the curve (AUC) C-peptide from the 2-h mixed meal tolerance test. RESULTS One hundred and twenty-six subjects were randomized and treated during the trial. The geometric mean C-peptide AUC at 2 years was unaffected by MMF alone or MMF plus DZB versus placebo. Adverse events were more frequent in the active therapy groups relative to the control group, but not significantly. CONCLUSIONS Neither MMF alone nor MMF in combination with DZB had an effect on the loss of C-peptide in subjects with new-onset type 1 diabetes. Higher doses or more targeted immunotherapies may be needed to affect the autoimmune process. PMID:20067954

Multicenter Randomized Controlled Trial on Duration of Therapy for Thrombosis in Children and Young Adults (Kids-DOTT): Pilot/Feasibility Phase Findings

PubMed Central

Goldenberg, N.A.; Abshire, T.; Blatchford, P.J.; Fenton, L.Z.; Halperin, J.L.; Hiatt, W.R.; Kessler, C.M.; Kittelson, J.M.; Manco-Johnson, M.J.; Spyropoulos, A.C.; Steg, P.G.; Stence, N.V.; Turpie, A.G.G.; Schulman, S.

2015-01-01

BACKGROUND Randomized controlled trials (RCTs) in pediatric venous thromboembolism (VTE) treatment have been challenged by unsubstantiated design assumptions and/or poor accrual. Pilot/feasibility (P/F) studies are critical to future RCT success. METHODS Kids-DOTT is a multicenter RCT investigating non-inferiority of a 6-week (shortened) vs. 3-month (conventional) duration of anticoagulation in patients <21 years old with provoked venous thrombosis. Primary efficacy and safety endpoints are symptomatic recurrent VTE at 1 year and anticoagulant-related, clinically-relevant bleeding. In the P/F phase, 100 participants were enrolled in an open, blinded endpoint, parallel-cohort RCT design. RESULTS No eligibility violations or randomization errors occurred. Of enrolled patients, 69% were randomized, 3% missed the randomization window, and 28% were followed in pre-specified observational cohorts for completely occlusive thrombosis or persistent antiphospholipid antibodies. Retention at 1 year was 82%. Inter-observer agreement between local vs. blinded central determination of venous occlusion by imaging at 6 weeks post-diagnosis was strong (κ-statistic=0.75; 95% confidence interval [CI] 0.48–1.0). Primary efficacy and safety event rates were 3.3% (95% CI 0.3–11.5%) and 1.4% (0.03–7.4%). CONCLUSIONS The P/F phase of Kids-DOTT has demonstrated validity of vascular imaging findings of occlusion as a randomization criterion, and defined randomization, retention, and endpoint rates to inform the fully-powered RCT. PMID:26118944

A multicenter randomized controlled fellow eye trial of pulse-dosed difluprednate 0.05% versus prednisolone acetate 1% in cataract surgery.

PubMed

Donnenfeld, Eric D; Holland, Edward J; Solomon, Kerry D; Fiore, Jay; Gobbo, Anthony; Prince, Jessica; Sandoval, Helga P; Shull, Emily R; Perry, Henry D

2011-10-01

To compare the effects of 2 corticosteroids on corneal thickness and visual acuity after cataract surgery. Multicenter, randomized, contralateral-eye, double-masked trial. Fifty-two patients (104 eyes) underwent bilateral phacoemulsification. The first eye randomly received difluprednate 0.05% or prednisolone acetate 1%; the fellow eye received the alternative. Before surgery, 7 doses were administered over 2 hours; 3 additional doses were given after surgery, before discharge. For the remainder of the day, corticosteroids were administered every 2 hours, then 4 times daily during week 1 and twice daily during week 2. Corneal pachymetry, visual acuity, and corneal edema were evaluated before surgery and at days 1, 15, and 30 after surgery. Endothelial cell counts were evaluated before surgery and at 30 days after surgery. Retinal thickness was evaluated before surgery and at 15 and 30 days after surgery. Corneal thickness at day 1 was 33 μm less in difluprednate-treated eyes (P = .026). More eyes were without corneal edema in the difluprednate group than in the prednisolone group at day 1 (62% vs 38%, respectively; P = .019). Uncorrected and best-corrected visual acuity at day 1 were significantly better with difluprednate than prednisolone by 0.093 logMAR lines (P = .041) and 0.134 logMAR lines (P < .001), respectively. Endothelial cell density was 195.52 cells/mm(2) higher in difluprednate-treated eyes at day 30 (P < .001). Retinal thickness at day 15 was 7.74 μm less in difluprednate-treated eyes (P = .011). In this high-dose pulsed-therapy regimen, difluprednate reduced inflammation more effectively than prednisolone acetate, resulting in more rapid return of vision. Difluprednate was superior at protecting the cornea and reducing macular thickening after cataract surgery. Copyright © 2011 Elsevier Inc. All rights reserved.

Cognitive-Behavioral and Psychodynamic Therapy in Adolescents with Social Anxiety Disorder: A Multicenter Randomized Controlled Trial.

PubMed

Salzer, Simone; Stefini, Annette; Kronmüller, Klaus-Thomas; Leibing, Eric; Leichsenring, Falk; Henningsen, Peter; Peseschkian, Hamid; Reich, Günter; Rosner, Rita; Ruhl, Uwe; Schopf, Yvonne; Steinert, Christiane; Vonderlin, Eva; Steil, Regina

2018-06-12

Although social anxiety disorder (SAD) has an early onset and is frequently found in adolescence, evidence for psychotherapeutic treatments of SAD in adolescents is rather scarce. Within the Social Phobia Psychotherapy Research Network (SOPHO-NET), we examined the efficacy of cognitive-behavioral (CBT) and psychodynamic therapy (PDT) compared to a waiting list (WL) in these patients. In a multicenter randomized controlled superiority trial, 107 patients, aged 14-20 years, were randomized to CBT (n = 34), PDT (n = 34), or WL (n = 39). Assessments were made at baseline, at the end of treatment, and 6 and 12 months after termination. The Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-CA) applied by raters masked to the treatment condition was used as the primary outcome. As secondary outcomes, rates of response and remission and the Social Phobia Anxiety Inventory (SPAI) were used. Both treatments were superior to WL in the LSAS-CA (CBT: p = 0.0112, d = 0.61, 95% CI 0.14-1.08; PDT: p = 0.0261, d = 0.53, 95% CI 0.06-1.00). At the end of treatment, response rates were 66, 54, and 20% for CBT, PDT, and WL. The corresponding remission rates were 47, 34, and 6%, respectively. CBT and PDT were significantly superior to WL regarding remission (CBT: p = 0.0009, h = 1.0; PDT: p = 0.0135, h = 0.74), response (CBT: p = 0.0004, h = 0.97; PDT: p = 0.0056, h = 0.72), and the SPAI (CBT: p = 0.0021, d = 0.75, 95% CI 0.27-1.22; PDT: p = 0.0060, d = 0.66, 95% CI 0.19-1.13). Treatment effects were stable at 6- and 12-month follow-ups. These results are comparable to the large SOPHO-NET trial in adults (n = 495). Early treatments for social anxiety are needed in order to prevent chronic manifestation of SAD. © 2018 S. Karger AG, Basel.

Effect of Oral Valproic Acid vs Placebo for Vision Loss in Patients With Autosomal Dominant Retinitis Pigmentosa: A Randomized Phase 2 Multicenter Placebo-Controlled Clinical Trial.

PubMed

Birch, David G; Bernstein, Paul S; Iannacone, Alessandro; Pennesi, Mark E; Lam, Byron L; Heckenlively, John; Csaky, Karl; Hartnett, Mary Elizabeth; Winthrop, Kevin L; Jayasundera, Thiran; Hughbanks-Wheaton, Dianna K; Warner, Judith; Yang, Paul; Fish, Gary Edd; Teske, Michael P; Sklaver, Neal L; Erker, Laura; Chegarnov, Elvira; Smith, Travis; Wahle, Aimee; VanVeldhuisen, Paul C; McCormack, Jennifer; Lindblad, Robert; Bramer, Steven; Rose, Stephen; Zilliox, Patricia; Francis, Peter J; Weleber, Richard G

2018-06-07

There are no approved drug treatments for autosomal dominant retinitis pigmentosa, a relentlessly progressive cause of adult and childhood blindness. To evaluate the potential efficacy and assess the safety of orally administered valproic acid (VPA) in the treatment of autosomal dominant retinitis pigmentosa. Multicenter, phase 2, prospective, interventional, placebo-controlled, double-masked randomized clinical trial. The study took place in 6 US academic retinal degeneration centers. Individuals with genetically characterized autosomal dominant retinitis pigmentosa were randomly assigned to receive treatment or placebo for 12 months. Analyses were intention-to-treat. Oral VPA 500 mg to 1000 mg daily for 12 months or placebo. The primary outcome measure was determined prior to study initiation as the change in visual field area (assessed by the III4e isopter, semiautomated kinetic perimetry) between baseline and month 12. The mean (SD) age of the 90 participants was 50.4 (11.6) years. Forty-four (48.9%) were women, 87 (96.7%) were white, and 79 (87.8%) were non-Hispanic. Seventy-nine participants (87.8%) completed the study (42 [95.5%] received placebo and 37 [80.4%] received VPA). Forty-two (46.7%) had a rhodopsin mutation. Most adverse events were mild, although 7 serious adverse events unrelated to VPA were reported. The difference between the VPA and placebo arms for mean change in the primary outcome was -150.43 degree2 (95% CI, -290.5 to -10.03; P = .035). This negative value indicates that the VPA arm had worse outcomes than the placebo group. This study brings to light the key methodological considerations that should be applied to the rigorous evaluation of treatments for these conditions. This study does not provide support for the use of VPA in the treatment of autosomal dominant retinitis pigmentosa. ClinicalTrials.gov Identifier: NCT01233609.

Efficacy and safety of two new formulations of artificial tears in subjects with dry eye disease: a 3-month, multicenter, active-controlled, randomized trial

PubMed Central

Simmons, Peter A; Liu, Haixia; Carlisle-Wilcox, Cindy; Vehige, Joseph G

2015-01-01

Purpose To evaluate and compare the efficacy and safety of two investigational artificial tear formulations (CHO-1 and CHO-2) containing carmellose sodium, hyaluronic acid at different concentrations, and osmoprotectants, with a standard carmellose sodium-containing formulation (Refresh Tears [RT]) in the treatment of dry eye disease. Subjects and methods In this 3-month, double-masked, multicenter study, subjects (n=305) were randomized 1:1:1 to receive CHO-1, CHO-2, or RT, used as needed but at least twice daily. The primary endpoint was change in ocular surface disease index (OSDI) score from baseline to day 90. Other key outcomes included symptoms evaluated on a visual analog scale, corneal and conjunctival staining, and adverse events. Results OSDI scores and dry eye symptoms showed a rapid and sustained reduction from baseline in each group. Both CHO-1 and CHO-2 met the primary efficacy endpoint of noninferiority to RT in day 90 OSDI score change from baseline. OSDI ocular symptoms subscale improved more with CHO-1 than CHO-2 (P=0.048). In subjects with clinically relevant baseline ocular surface staining (>14 total score of a maximum of 55), day 90 improvements were greater with CHO-1 and CHO-2 than RT (P≤0.044). Day 90 improvements in OSDI ocular symptoms subscale scores were also greater with CHO-1 than RT (P<0.007) in subjects with clinically relevant ocular staining. All treatments were well tolerated. Conclusion Both combination artificial tear formulations were efficacious and well tolerated in subjects with dry eye. CHO-1 demonstrated the best performance in improving ocular symptoms and reducing ocular staining in this heterogeneous study population. PMID:25931807

venice: Mask utility

NASA Astrophysics Data System (ADS)

Coupon, Jean

2018-02-01

venice reads a mask file (DS9 or fits type) and a catalogue of objects (ascii or fits type) to create a pixelized mask, find objects inside/outside a mask, or generate a random catalogue of objects inside/outside a mask. The program reads the mask file and checks if a point, giving its coordinates, is inside or outside the mask, i.e. inside or outside at least one polygon of the mask.

Single-Incision Multiport/Single Port Laparoscopic Abdominal Surgery (SILAP): A Prospective Multicenter Observational Quality Study.

PubMed

Mantke, Rene; Diener, Markus; Kropf, Siegfried; Otto, Ronny; Manger, Thomas; Vestweber, Boris; Mirow, Lutz; Winde, Günther; Lippert, Hans

2016-09-07

Increasing experience with minimally invasive surgery and the development of new instruments has resulted in a tendency toward reducing the number of abdominal skin incisions. Retrospective and randomized prospective studies could show the feasibility of single-incision surgery without any increased risk to the patient. However, large prospective multicenter observational datasets do not currently exist. This prospective multicenter observational quality study will provide a relevant dataset reflecting the feasibility and safety of single-incision surgery. This study focuses on external validity, clinical relevance, and the patients' perspective. Accordingly, the single-incision multiport/single port laparoscopic abdominal surgery (SILAP) study will supplement the existing evidence, which does not currently allow evidence-based surgical decision making. The SILAP study is an international prospective multicenter observational quality study. Mortality, morbidity, complications during surgery, complications postoperatively, patient characteristics, and technical aspects will be monitored. We expect more than 100 surgical centers to participate with 5000 patients with abdominal single-incision surgery during the study period. Funding was obtained in 2012. Enrollment began on January 01, 2013, and will be completed on December 31, 2018. As of January 2016, 2119 patients have been included, 106 German centers are registered, and 27 centers are very active (>5 patients per year). This prospective multicenter observational quality study will provide a relevant dataset reflecting the feasibility and safety of single-incision surgery. An international enlargement and recruitment of centers outside of Germany is meaningful. German Clinical Trials Register: DRKS00004594; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00004594 (Archived by WebCite at http://www.webcitation.org/6jK6ZVyUs).

Supreme Laryngeal Mask Airway versus Face Mask during Neonatal Resuscitation: A Randomized Controlled Trial.

PubMed

Trevisanuto, Daniele; Cavallin, Francesco; Nguyen, Loi Ngoc; Nguyen, Tien Viet; Tran, Linh Dieu; Tran, Chien Dinh; Doglioni, Nicoletta; Micaglio, Massimo; Moccia, Luciano

2015-08-01

To assess the effectiveness of supreme laryngeal mask airway (SLMA) over face mask ventilation for preventing need for endotracheal intubation at birth. We report a prospective, randomized, parallel 1:1, unblinded, controlled trial. After a short-term educational intervention on SLMA use, infants ≥34-week gestation and/or expected birth weight ≥1500 g requiring positive pressure ventilation (PPV) at birth were randomized to resuscitation by SLMA or face mask. The primary outcome was the success rate of the resuscitation devices (SLMA or face mask) defined as the achievement of an effective PPV preventing the need for endotracheal intubation. We enrolled 142 patients (71 in SLMA and 71 in face mask group, respectively). Successful resuscitation rate was significantly higher with the SLMA compared with face mask ventilation (91.5% vs 78.9%; P = .03). Apgar score at 5 minutes was significantly higher in SLMA than in face mask group (P = .02). Neonatal intensive care unit admission rate was significantly lower in SLMA than in face mask group (P = .02). No complications related to the procedure occurred. In newborns with gestational age ≥34 weeks and/or expected birth weight ≥1500 g needing PPV at birth, the SLMA is more effective than face mask to prevent endotracheal intubation. The SLMA is effective in clinical practice after a short-term educational intervention. Registered with ClinicalTrials.gov: NCT01963936. Copyright © 2015 Elsevier Inc. All rights reserved.

Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry.

PubMed

Allareddy, Veerasathpurush; Rampa, Sankeerth; Masoud, Mohamed I; Lee, Min Kyeong; Nalliah, Romesh; Allareddy, Veerajalandhar

2014-11-01

The Food and Drug Administration Modernization Act of 1997 made it mandatory for all phase II through IV trials regulated by this Act to be registered. After this, the National Institutes of Health created ClinicalTrials.gov, which is a registry of publicly and privately supported clinical studies of human participants. The objective of this study was to examine the characteristics of registered studies in orthodontics. The ClinicalTrials.gov Web site was used to query all registered orthodontic studies. The search term used was "orthodontics." No limitations were placed for the time period. All registered studies regardless of their recruitment status, study results, and study type were selected for analysis. A total of 64 orthodontic studies were registered as of January 1, 2014. Of these, 52 were interventional, and 12 were observational. Close to 60% of the interventional studies and 66.7% of the observational studies had sample sizes of 50 or fewer subjects. About 21.2% of the interventional studies and 16.7% of the observational studies had sample sizes greater than 100. Only 1 study was funded by the National Institutes of Health, and the rest were funded by "other" or "industry" sources. Close to 87.7% of the interventional studies were randomized. Interventional model assignments included factorial assignment (3.9%), parallel assignments (74.5%), crossover assignment (7.8%), and single-group assignment (13.7%). Most studies were treatment oriented (80.4%). The types of masking used by the interventional studies included open label (28.9%), single blind (44.2%), and double blind (26.9%). Outcome assessors were blinded in only 6 studies. Orthodontic studies registered in ClinicalTrials.gov are dominated by small single-center studies. There are wide variations with regard to treatment allocation approaches and randomization methods in the studies. These results also indicate the need for multicenter clinical studies in orthodontics. Copyright © 2014 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

Operating Room Performance Improves after Proficiency-Based Virtual Reality Cataract Surgery Training.

PubMed

Thomsen, Ann Sofia Skou; Bach-Holm, Daniella; Kjærbo, Hadi; Højgaard-Olsen, Klavs; Subhi, Yousif; Saleh, George M; Park, Yoon Soo; la Cour, Morten; Konge, Lars

2017-04-01

To investigate the effect of virtual reality proficiency-based training on actual cataract surgery performance. The secondary purpose of the study was to define which surgeons benefit from virtual reality training. Multicenter masked clinical trial. Eighteen cataract surgeons with different levels of experience. Cataract surgical training on a virtual reality simulator (EyeSi) until a proficiency-based test was passed. Technical performance in the operating room (OR) assessed by 3 independent, masked raters using a previously validated task-specific assessment tool for cataract surgery (Objective Structured Assessment of Cataract Surgical Skill). Three surgeries before and 3 surgeries after the virtual reality training were video-recorded, anonymized, and presented to the raters in random order. Novices (non-independently operating surgeons) and surgeons having performed fewer than 75 independent cataract surgeries showed significant improvements in the OR-32% and 38%, respectively-after virtual reality training (P = 0.008 and P = 0.018). More experienced cataract surgeons did not benefit from simulator training. The reliability of the assessments was high with a generalizability coefficient of 0.92 and 0.86 before and after the virtual reality training, respectively. Clinically relevant cataract surgical skills can be improved by proficiency-based training on a virtual reality simulator. Novices as well as surgeons with an intermediate level of experience showed improvement in OR performance score. Copyright © 2017 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Effectiveness of three just-in-time training modalities for N-95 mask fit testing.

PubMed

Jones, David; Stoler, Genevieve; Suyama, Joe

2013-01-01

To compare and contrast three different training modalities for fit testing N-95 respirator face masks. Block randomized interventional study. Urban university. Two hundred eighty-nine medical students. Students were randomly assigned to video, lecture, or slide show to evaluate the effectiveness of the methods for fit testing large groups of people. Ease of fit and success of fit for each instructional technique. Mask 1 was a Kimberly-Clark duckbill N-95 respirator mask, and mask 2 was a 3M™ carpenters N-95 respirator mask. "Ease of fit" was defined as the ability to successfully don a mask in less than 30 seconds. "Success of fit" was defined as the ability to correctly don a mask in one try. There were no statistical differences by training modality for either mask regarding ease of fit or success of fit. There were no differences among video presentation, small group demonstration, and self-directed slide show just-in-time training modalities for ease of fit or success of fit N-95 respirator mask fitting. Further study is needed to explore more effective fit training modalities.

Designing and conducting a randomized trial for pandemic critical illness: the 2009 H1N1 influenza pandemic.

PubMed

Annane, Djillali; Antona, Marion; Lehmann, Blandine; Kedzia, Cecile; Chevret, Sylvie

2012-01-01

To analyze the hurdles in implementing a randomized trial of corticosteroids for severe 2009 H1N1 influenza infections. This was an investigator-led, multicenter, randomized, placebo-controlled, double-blind trial of corticosteroids in ICU patients with 2009 H1N1 influenza pneumonia requiring mechanical ventilation. The feasibility of and hurdles in designing and initiating a phase III trial in a short-lived pandemic crisis were analyzed. The regulatory agency and ethics committee approved the study's scientific, financial, and ethical aspects within 4 weeks. Hydrocortisone and placebo were prepared centrally and shipped to participating hospitals within 6 weeks. The inclusion period started on November 9, 2009. From August 1, 2009 to March 8, 2010, only 205/224 ICU patients with H1N1 infections required mechanical ventilation. The peak of the wave was missed by 2-3 weeks and only 26 patients were randomized. The two main reasons for non-inclusion were patients' admission before the beginning of the trial and ICU personnel overwhelmed by clinical duties. Parallel rather than sequential regulatory and ethics approval, and preparation and masking of study drugs by local pharmacists would have allowed the study to start 1 month earlier and before the peak of the "flu" wave. A dedicated research team in each participating center would have increased the ratio of screened to randomized patients. This report highlights the main hurdles in implementing a randomized trial for a pandemic critical illness and proposes solutions for future trials.

Impact of different nasal masks on CPAP therapy for obstructive sleep apnea: a randomized comparative trial.

PubMed

Neuzeret, Pierre-Charles; Morin, Laurent

2017-11-01

Patient interface is important for the success of continuous positive airway pressure (CPAP), but few trials have examined the influence of mask choice on CPAP adherence. To compare the impact of different nasal masks on CPAP in patients with newly-diagnosed obstructive sleep apnea (OSA). OSA patients were randomized in a 2:3 ratio to receive CPAP via different first-line nasal masks: ResMed Mirage FX® (MFX) or control mask (Fisher & Paykel Zest ® , HC407 ® or Philips EasyLife ® ). Mask acceptance, CPAP compliance and Home Care Provider (HCP) interventions were compared between groups after 3 months of CPAP therapy using modified intent-to-treat (mITT; after exclusion of patients with mouth leaks during CPAP initiation) and on-treatment (OT; CPAP adherent) analyses. Of 285 randomized patients, 90 requiring a full-face mask were excluded, leaving 195 and 151 in the mITT and OT analyses, respectively. Mask acceptance rate was higher in the MFX versus control group (mITT: 79% vs 68%, P = 0.067; OT: 90% vs 76%, P = 0.022). CPAP compliance was higher (5.9 ± 1.8 vs 5.1 ± 1.6 h/night, P = 0.011) and nasal mask issue-related HCP visits lower (3% vs 17%, P = 0.006) in the MFX group. Nasal mask failures due to mask discomfort (5% vs 1%) or unintentional leakage (5% vs 0%) were higher in control vs MFX group. Mask acceptance was significantly associated with fewer mask leaks (P = 0.002) and higher pressure therapy (P = 0.042). This study highlights differences between nasal masks for CPAP delivery and shows that initial mask selection can influence adherence and healthcare utilization during CPAP. © 2016 ResMed Germany Inc. The Clinical Respiratory Journal published by John Wiley & Sons Ltd.

Video encryption using chaotic masks in joint transform correlator

NASA Astrophysics Data System (ADS)

Saini, Nirmala; Sinha, Aloka

2015-03-01

A real-time optical video encryption technique using a chaotic map has been reported. In the proposed technique, each frame of video is encrypted using two different chaotic random phase masks in the joint transform correlator architecture. The different chaotic random phase masks can be obtained either by using different iteration levels or by using different seed values of the chaotic map. The use of different chaotic random phase masks makes the decryption process very complex for an unauthorized person. Optical, as well as digital, methods can be used for video encryption but the decryption is possible only digitally. To further enhance the security of the system, the key parameters of the chaotic map are encoded using RSA (Rivest-Shamir-Adleman) public key encryption. Numerical simulations are carried out to validate the proposed technique.

Intraocular pressure decrease with preservative-free fixed and unfixed combination of tafluprost and timolol in pseudoexfoliative glaucoma.

PubMed

Holló, Gábor; Ropo, Auli

2015-01-01

We investigated the intraocular pressure (IOP) lowering efficacy of preservative-free fixed and non-fixed combination of tafluprost 0.0015% and timolol 0.5% in pseudoexfoliative glaucoma (XFG). A per protocol worse eye analysis was made on all XFG patients who participated in a recent 6 month, prospective, randomized, double-masked, parallel group, multicenter phase III study. The mean time-wise IOP decreased by 8.62 to 10.25 mmHg (31.8 to 36.7%) in the fixed dose combination arm (15 patients) and by 5.38 to 11.35 mmHg (21.3 to 41.2%) in the non-fixed combination arm (13 patients), respectively (p < 0.001 for all comparisons). The results show that a preservative-free fixed dose combination of tafluprost and timolol provides a clinically significant IOP reduction in XFG, and may offer an advantage for the XFG patients with dry eye, due to its preservative-free nature.

Randomized controlled trial on the effects of CCTV training on quality of life, depression, and adaptation to vision loss.

PubMed

Burggraaff, Marloes C; van Nispen, Ruth M A; Knol, Dirk L; Ringens, Peter J; van Rens, Ger H M B

2012-06-14

In addition to performance-based measures, vision-related quality of life (QOL) and other subjective measures of psychosocial functioning are considered important outcomes of training in the visually impaired. In a multicenter, masked, randomized controlled trial, subjective effects of training in the use of closed-circuit televisions (CCTV) were investigated. Patients (n = 122) were randomized either to a treatment group that received usual delivery instructions from the supplier combined with concise outpatient training, or to a control group that received delivery instructions only. Subjective outcomes were the low vision quality-of-life questionnaire (LVQOL), EuroQOL 5 dimensions, adaptation to age-related vision loss (AVL), and the Center of Epidemiologic Studies Depression scales. Linear mixed models were used to investigate treatment effects. Differential effects of patient characteristics were studied by implementing higher order interactions into the models. From baseline to follow-up, all patients perceived significantly less problems on the reading and fine work dimension (-28.8 points; P < 0.001) and the adaptation dimension (-4.67 points; P = 0.04) of the LVQOL. However, no treatment effect was found based on the intention-to-treat analysis. This study demonstrated the effect of receiving and using a CCTV on two vision-related QOL dimensions; however, outpatient training in the use of CCTVs had no additional value. (trialregister.nl number, NTR1031.).

Nasal versus oronasal continuous positive airway pressure masks for obstructive sleep apnea: a pilot investigation of pressure requirement, residual disease, and leak.

PubMed

Bakker, Jessie P; Neill, Alister M; Campbell, Angela J

2012-09-01

This single-blinded, randomized, controlled pilot study aimed to investigate whether there is a difference between nasal and oronasal masks in therapeutic continuous positive airway pressure (CPAP) requirement, residual disease, or leak when treating obstructive sleep apnea (OSA) and if differences were related to measures of upper airway size. Patients with severe OSA currently using CPAP at ≥4 h/night with a nasal mask were examined (including Mallampati scale, incisal relationship, and mandibular protrusion) and then randomized to receive auto-positive airway pressure (PAP) or fixed CPAP at a manually titrated pressure for 1 week each at home, with immediate crossover. Within each week, a nasal mask and two oronasal masks were to be used for two or three nights each in random order. Data were downloaded from the device. Twelve patients completed the trial (mean ± SD AHI 59.8 ± 28.6 events/h; CPAP 11.1 ± 3.2 cmH(2)O; BMI 37.7 ± 5.0 kg/m(2)). During auto-PAP, the median 95th percentile pressure delivered with all masks was within 0.5 cmH(2)O (p > 0.05). During CPAP, median residual AHI was 0.61 (IQR = 1.18) for the nasal mask, 1.70 (IQR = 4.04) for oronasal mask 1, and 2.48 (IQR = 3.74) for oronasal mask 2 (p = 0.03). The 95th percentile leak was lowest with the nasal mask during both CPAP and auto-PAP (both p < 0.01). Differences in pressure or residual disease were not related to measures of upper airway shape or body habitus. In obese OSA patients changing from a nasal to oronasal mask increased leak and residual AHI but did not affect the therapeutic pressure requirement. The findings of the current study highlight mask leak as the major difficulty in the use of oronasal masks.

A randomised crossover comparison of mouth-to-face-shield ventilation and mouth-to-pocket-mask ventilation by surf lifeguards in a manikin.

PubMed

Adelborg, K; Bjørnshave, K; Mortensen, M B; Espeseth, E; Wolff, A; Løfgren, B

2014-07-01

Thirty surf lifeguards (mean (SD) age: 25.1 (4.8) years; 21 male, 9 female) were randomly assigned to perform 2 × 3 min of cardiopulmonary resuscitation on a manikin using mouth-to-face-shield ventilation (AMBU LifeKey) and mouth-to-pocket-mask ventilation (Laerdal Pocket Mask). Interruptions in chest compressions, effective ventilation (visible chest rise) ratio, tidal volume and inspiratory time were recorded. Interruptions in chest compressions per cycle were increased with mouth-to-face-shield ventilation (mean (SD) 8.6 (1.7) s) compared with mouth-to-pocket-mask ventilation (6.9 (1.2) s, p < 0.0001). The proportion of effective ventilations was less using mouth-to-face-shield ventilation (199/242 (82%)) compared with mouth-to-pocket-mask ventilation (239/240 (100%), p = 0.0002). Tidal volume was lower using mouth-to-face-shield ventilation (mean (SD) 0.36 (0.20) l) compared with mouth-to-pocket-mask ventilation (0.45 (0.20) l, p = 0.006). No differences in inspiratory times were observed between mouth-to-face-shield ventilation and mouth-to-pocket-mask ventilation. In conclusion, mouth-to-face-shield ventilation increases interruptions in chest compressions, reduces the proportion of effective ventilations and decreases delivered tidal volumes compared with mouth-to-pocket-mask ventilation. © 2014 The Association of Anaesthetists of Great Britain and Ireland.

Masking of low-frequency signals by high-frequency, high-level narrow bands of noisea

PubMed Central

Patra, Harisadhan; Roup, Christina M.; Feth, Lawrence L.

2011-01-01

Low-frequency masking by intense high-frequency noise bands, referred to as remote masking (RM), was the first evidence to challenge energy-detection models of signal detection. Its underlying mechanisms remain unknown. RM was measured in five normal-hearing young-adults at 250, 350, 500, and 700 Hz using equal-power, spectrally matched random-phase noise (RPN) and low-noise noise (LNN) narrowband maskers. RM was also measured using equal-power, two-tone complex (TC2) and eight-tone complex (TC8). Maskers were centered at 3000 Hz with one or two equivalent rectangular bandwidths (ERBs). Masker levels varied from 80 to 95 dB sound pressure level in 5 dB steps. LNN produced negligible masking for all conditions. An increase in bandwidth in RPN yielded greater masking over a wider frequency region. Masking for TC2 was limited to 350 and 700 Hz for one ERB but shifted to only 700 Hz for two ERBs. A spread of masking to 500 and 700 Hz was observed for TC8 when the bandwidth was increased from one to two ERBs. Results suggest that high-frequency noise bands at high levels could generate significant low-frequency masking. It is possible that listeners experience significant RM due to the amplification of various competing noises that might have significant implications for speech perception in noise. PMID:21361445

Using automated texture features to determine the probability for masking of a tumor on mammography, but not ultrasound.

PubMed

Häberle, Lothar; Hack, Carolin C; Heusinger, Katharina; Wagner, Florian; Jud, Sebastian M; Uder, Michael; Beckmann, Matthias W; Schulz-Wendtland, Rüdiger; Wittenberg, Thomas; Fasching, Peter A

2017-08-30

Tumors in radiologically dense breast were overlooked on mammograms more often than tumors in low-density breasts. A fast reproducible and automated method of assessing percentage mammographic density (PMD) would be desirable to support decisions whether ultrasonography should be provided for women in addition to mammography in diagnostic mammography units. PMD assessment has still not been included in clinical routine work, as there are issues of interobserver variability and the procedure is quite time consuming. This study investigated whether fully automatically generated texture features of mammograms can replace time-consuming semi-automatic PMD assessment to predict a patient's risk of having an invasive breast tumor that is visible on ultrasound but masked on mammography (mammography failure). This observational study included 1334 women with invasive breast cancer treated at a hospital-based diagnostic mammography unit. Ultrasound was available for the entire cohort as part of routine diagnosis. Computer-based threshold PMD assessments ("observed PMD") were carried out and 363 texture features were obtained from each mammogram. Several variable selection and regression techniques (univariate selection, lasso, boosting, random forest) were applied to predict PMD from the texture features. The predicted PMD values were each used as new predictor for masking in logistic regression models together with clinical predictors. These four logistic regression models with predicted PMD were compared among themselves and with a logistic regression model with observed PMD. The most accurate masking prediction was determined by cross-validation. About 120 of the 363 texture features were selected for predicting PMD. Density predictions with boosting were the best substitute for observed PMD to predict masking. Overall, the corresponding logistic regression model performed better (cross-validated AUC, 0.747) than one without mammographic density (0.734), but less well than the one with the observed PMD (0.753). However, in patients with an assigned mammography failure risk >10%, covering about half of all masked tumors, the boosting-based model performed at least as accurately as the original PMD model. Automatically generated texture features can replace semi-automatically determined PMD in a prediction model for mammography failure, such that more than 50% of masked tumors could be discovered.

A Randomized Controlled Study of Art Observation Training to Improve Medical Student Ophthalmology Skills.

PubMed

Gurwin, Jaclyn; Revere, Karen E; Niepold, Suzannah; Bassett, Barbara; Mitchell, Rebecca; Davidson, Stephanie; DeLisser, Horace; Binenbaum, Gil

2018-01-01

Observation and description are critical to the practice of medicine, and to ophthalmology in particular. However, medical education does not provide explicit training in these areas, and medical students are often criticized for deficiencies in these skills. We sought to evaluate the effects of formal observation training in the visual arts on the general and ophthalmologic observational skills of medical students. Randomized, single-masked, controlled trial. Thirty-six first-year medical students, randomized 1:1 into art-training and control groups. Students in the art-training group were taught by professional art educators at the Philadelphia Museum of Art, during 6 custom-designed, 1.5-hour art observation sessions over a 3-month period. All subjects completed pre- and posttesting, in which they described works of art, retinal pathology images, and external photographs of eye diseases. Grading of written descriptions for observational and descriptive abilities by reviewers using an a priori rubric and masked to group assignment and pretesting/posttesting status. Observational skills, as measured by description testing, improved significantly in the training group (mean change +19.1 points) compared with the control group (mean change -13.5 points), P = 0.001. There were significant improvements in the training vs. control group for each of the test subscores. In a poststudy questionnaire, students reported applying the skills they learned in the museum in clinically meaningful ways at medical school. Art observation training for first-year medical students can improve clinical ophthalmology observational skills. Principles from the field of visual arts, which is reputed to excel in teaching observation and descriptive abilities, can be successfully applied to medical training. Further studies can examine the impact of such training on clinical care. Copyright © 2017 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Color image encryption based on gyrator transform and Arnold transform

NASA Astrophysics Data System (ADS)

Sui, Liansheng; Gao, Bo

2013-06-01

A color image encryption scheme using gyrator transform and Arnold transform is proposed, which has two security levels. In the first level, the color image is separated into three components: red, green and blue, which are normalized and scrambled using the Arnold transform. The green component is combined with the first random phase mask and transformed to an interim using the gyrator transform. The first random phase mask is generated with the sum of the blue component and a logistic map. Similarly, the red component is combined with the second random phase mask and transformed to three-channel-related data. The second random phase mask is generated with the sum of the phase of the interim and an asymmetrical tent map. In the second level, the three-channel-related data are scrambled again and combined with the third random phase mask generated with the sum of the previous chaotic maps, and then encrypted into a gray scale ciphertext. The encryption result has stationary white noise distribution and camouflage property to some extent. In the process of encryption and decryption, the rotation angle of gyrator transform, the iterative numbers of Arnold transform, the parameters of the chaotic map and generated accompanied phase function serve as encryption keys, and hence enhance the security of the system. Simulation results and security analysis are presented to confirm the security, validity and feasibility of the proposed scheme.

A consistent NPMLE of the joint distribution function with competing risks data under the dependent masking and right-censoring model.

PubMed

Li, Jiahui; Yu, Qiqing

2016-01-01

Dinse (Biometrics, 38:417-431, 1982) provides a special type of right-censored and masked competing risks data and proposes a non-parametric maximum likelihood estimator (NPMLE) and a pseudo MLE of the joint distribution function [Formula: see text] with such data. However, their asymptotic properties have not been studied so far. Under the extention of either the conditional masking probability (CMP) model or the random partition masking (RPM) model (Yu and Li, J Nonparametr Stat 24:753-764, 2012), we show that (1) Dinse's estimators are consistent if [Formula: see text] takes on finitely many values and each point in the support set of [Formula: see text] can be observed; (2) if the failure time is continuous, the NPMLE is not uniquely determined, and the standard approach (which puts weights only on one element in each observed set) leads to an inconsistent NPMLE; (3) in general, Dinse's estimators are not consistent even under the discrete assumption; (4) we construct a consistent NPMLE. The consistency is given under a new model called dependent masking and right-censoring model. The CMP model and the RPM model are indeed special cases of the new model. We compare our estimator to Dinse's estimators through simulation and real data. Simulation study indicates that the consistent NPMLE is a good approximation to the underlying distribution for moderate sample sizes.

Management of post-LASIK dry eye: a multicenter randomized comparison of a new multi-ingredient artificial tear to carboxymethylcellulose

PubMed Central

Wallerstein, Avi; Jackson, W Bruce; Chambers, Jeffrey; Moezzi, Amir M; Lin, Hugh; Simmons, Peter A

2018-01-01

Purpose To compare the efficacy and safety of a preservative-free, multi-ingredient formulation of carboxymethylcellulose 0.5%, hyaluronic acid 0.1%, and organic osmolytes (CMC-HA), to preservative-free carboxymethylcellulose 0.5% (CMC) in the management of postoperative signs and symptoms of dry eye following laser-assisted in situ keratomileusis (LASIK). Methods This was a double-masked, randomized, parallel-group study conducted in 14 clinical centers in Canada and Australia. Subjects with no more than mild dry eye instilled CMC-HA or CMC for 90 days post-LASIK. Ocular Surface Disease Index© (OSDI; primary efficacy measure), corneal staining, tear break-up time (TBUT), Schirmer’s test, acceptability/tolerability surveys, and visual acuity were assessed at screening and days 2, 10, 30, 60, and 90 post-surgery. Safety analyses included all enrolled. Results A total of 148 subjects (CMC-HA, n=75; CMC, n=73) were enrolled and assigned to receive treatment, and 126 subjects completed the study without any protocol violations. Post-LASIK, dry eye signs/symptoms peaked at 10 days. OSDI scores for both groups returned to normal with no differences between treatment groups at day 90 (P=0.775). Corneal staining, Schirmer’s test, TBUT, and survey results were comparable. Higher mean improvements in uncorrected visual acuity were observed in the CMC-HA group at all study visits, reaching statistical significance at day 30 (P=0.013). Both treatments were well tolerated. Conclusion CMC-HA-containing artificial tears relieved post-LASIK ocular dryness as well as CMC alone, and demonstrated incremental benefit in uncorrected vision, with a favorable safety profile. Results support use of CMC-HA eye drops to reduce signs and symptoms of ocular dryness post-LASIK. PMID:29765198

Effect of Oral Re-esterified Omega-3 Nutritional Supplementation on Dry Eyes.

PubMed

Epitropoulos, Alice T; Donnenfeld, Eric D; Shah, Zubin A; Holland, Edward J; Gross, Michael; Faulkner, William J; Matossian, Cynthia; Lane, Stephen S; Toyos, Melissa; Bucci, Frank A; Perry, Henry D

2016-09-01

To assess the effect of oral re-esterified omega-3 fatty acids on tear osmolarity, matrix metalloproteinase-9 (MMP-9), tear break-up time (TBUT), Ocular Surface Disease Index (OSDI), fluorescein corneal staining, Schirmer score, meibomian gland dysfunction (MGD) stage and omega-3 index in subjects with dry eyes and confirmed MGD. This was a multicenter, prospective, interventional, placebo-controlled, double-masked study. Subjects were randomized to receive 4 softgels containing a total of 1680 mg of eicosapentaenoic acid/560 mg of docosahexaenoic acid or a control of 3136 mg of linoleic acid, daily for 12 weeks. Subjects were measured at baseline, week 6, and week 12 for tear osmolarity, TBUT, OSDI, fluorescein corneal staining, and Schirmer test with anesthesia. MMP-9 testing and omega-3 index were done at baseline and at 12 weeks. One hundred five subjects completed the study. They were randomized to omega-3 (n = 54) and control group (n = 51). Statistically significant reduction in tear osmolarity was observed in the omega-3 group versus control group at week 6 (-16.8 ± 2.6 vs. -9.0 ± 2.7 mOsm/L, P = 0.042) and week 12 (-19.4 ± 2.7 vs. -8.3 ± 2.8 mOsm/L, P = 0.004). At 12 weeks, a statistically significant increase in omega-3 index levels (P < 0.001) and TBUT (3.5 ± 0.5 s vs. 1.2 ± 0.5 s, P = 0.002) was also observed. Omega-3 group experienced a significant reduction in MMP-9 positivity versus control group (67.9% vs. 35.0%, P = 0.024) and OSDI scores decreased significantly in omega-3 (-17.0 ± 2.6) versus control group (-5.0 ± 2.7, P = 0.002). Oral consumption of re-esterified omega-3 fatty acids is associated with statistically significant improvement in tear osmolarity, omega-3 index levels, TBUT, MMP-9, and OSDI symptom scores.

Contextual influence on orientation discrimination of humans and responses of neurons in V1 of alert monkeys.

PubMed

Li, W; Thier, P; Wehrhahn, C

2000-02-01

We studied the effects of various patterns as contextual stimuli on human orientation discrimination, and on responses of neurons in V1 of alert monkeys. When a target line is presented along with various contextual stimuli (masks), human orientation discrimination is impaired. For most V1 neurons, responses elicited by a line in the receptive field (RF) center are suppressed by these contextual patterns. Orientation discrimination thresholds of human observers are elevated slightly when the target line is surrounded by orthogonal lines. For randomly oriented lines, thresholds are elevated further and even more so for lines parallel to the target. Correspondingly, responses of most V1 neurons to a line are suppressed. Although contextual lines inhibit the amplitude of orientation tuning functions of most V1 neurons, they do not systematically alter the tuning width. Elevation of human orientation discrimination thresholds decreases with increasing curvature of masking lines, so does the inhibition of V1 neuronal responses. A mask made of straight lines yields the strongest interference with human orientation discrimination and produces the strongest suppression of neuronal responses. Elevation of human orientation discrimination thresholds is highest when a mask covers only the immediate vicinity of the target line. Increasing the masking area results in less interference. On the contrary, suppression of neuronal responses in V1 increases with increasing mask size. Our data imply that contextual interference observed in human orientation discrimination is in part directly related to contextual inhibition of neuronal activity in V1. However, the finding that interference with orientation discrimination is weaker for larger masks suggests a figure-ground segregation process that is not located in V1.

LMA Supreme for neonatal resuscitation: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background The most important action in the resuscitation of a newborn in the delivery room is to establish effective assisted ventilation. The face mask and endotracheal tube are the devices used to achieve this goal. Laryngeal mask airways that fit over the laryngeal inlet have been shown to be effective for ventilating newborns at birth and should be considered as an alternative to facemask ventilation or endotracheal intubation among newborns weighing >2,000 g or delivered ≥34 weeks’ gestation. A recent systematic review and meta-analysis of supraglottic airways in neonatal resuscitation reported the results of four randomized controlled trials (RCTs) stating that fewer infants in the group using laryngeal mask airways required endotracheal intubation (1.5%) compared to the group using face masks (12.0%). However, there were methodological concerns over all the RCTs including the fact that the majority of the operators in the trials were anesthesiologists. Our hypothesis is based on the assumption that ventilating newborns needing positive pressure ventilation with a laryngeal mask airway will be more effective than ventilating with a face mask in a setting where neonatal resuscitation is performed by midwives, nurses, and pediatricians. The primary aim of this study will be to assess the effectiveness of the laryngeal mask airway over the face mask in preventing the need for endotracheal intubation. Methods/design This will be an open, prospective, randomized, single center, clinical trial. In this study, 142 newborns weighing >1,500 g or delivered ≥34 weeks gestation needing positive pressure ventilation at birth will be randomized to be ventilated with a laryngeal mask airway (LMA SupremeTM, LMA Company, UK - intervention group) or with a face mask (control group). Primary outcome: Proportion of newborns needing endotracheal intubation. Secondary outcomes: Apgar score at 5 minutes, time to first breath, onset of the first cry, duration of resuscitation, death or moderate to severe hypoxic-ischemic encephalopathy within 7 days of life. Trial registration ClinicalTrials.gov identifier: NCT01963936 (October 11, 2013). PMID:25027230

The steroids for corneal ulcers trial (SCUT): secondary 12-month clinical outcomes of a randomized controlled trial.

PubMed

Srinivasan, Muthiah; Mascarenhas, Jeena; Rajaraman, Revathi; Ravindran, Meenakshi; Lalitha, Prajna; O'Brien, Kieran S; Glidden, David V; Ray, Kathryn J; Oldenburg, Catherine E; Zegans, Michael E; Whitcher, John P; McLeod, Stephen D; Porco, Travis C; Lietman, Thomas M; Acharya, Nisha R

2014-02-01

To determine whether topical corticosteroids as adjunctive therapy for bacterial keratitis improves long-term clinical outcomes. Randomized, placebo-controlled, double-masked clinical trial. This multicenter trial compared 1.0% prednisolone sodium phosphate to placebo in the treatment of bacterial keratitis among 500 patients with culture-positive ulcers receiving 48 hours of moxifloxacin before randomization. The primary endpoint was 3 months from enrollment, and 399 patients were evaluated at 12 months. The outcomes examined were best spectacle-corrected visual acuity (BSCVA) and scar size at 12 months. Based on previous results, regression models with adjustments for baseline status and/or causative organism were used for analysis. No significant differences in clinical outcomes by treatment group were seen with the prespecified regression models (BSCVA: -0.04 logMAR, 95% CI, -0.12 to 0.05, P = .39; scar size: 0.03 mm, 95% CI, -0.12 to 0.18, P = .69). A regression model including a Nocardia-treatment arm interaction found corticosteroid use associated with a mean 1-line improvement in BSCVA at 12 months among patients with non-Nocardia ulcers (-0.10 logMAR, 95% CI, -0.19 to -0.02, P = .02). No significant difference was observed in 12-month BSCVA for Nocardia ulcers (0.18 logMAR, 95% CI, -0.04 to 0.41, P = .16). Corticosteroids were associated with larger mean scar size at 12 months among Nocardia ulcers (0.47 mm, 95% CI, 0.06-0.88, P = .02) and no significant difference was identified by treatment for scar size for non-Nocardia ulcers (-0.06 mm, 95% CI, -0.21 to 0.10, P = .46). Adjunctive topical corticosteroid therapy may be associated with improved long-term clinical outcomes in bacterial corneal ulcers not caused by Nocardia species. Copyright © 2014 Elsevier Inc. All rights reserved.

The Steroids for Corneal Ulcers Trial (SCUT): secondary 12-month clinical outcomes of a randomized controlled trial

PubMed Central

Srinivasan, Muthiah; Mascarenhas, Jeena; Rajaraman, Revathi; Ravindran, Meenakshi; Lalitha, Prajna; O’Brien, Kieran S.; Glidden, David V.; Ray, Kathryn J.; Oldenburg, Catherine E.; Zegans, Michael E.; Whitcher, John P.; McLeod, Stephen D.; Porco, Travis C.; Lietman, Thomas M.; Acharya, Nisha R.

2013-01-01

Purpose To determine whether topical corticosteroids as adjunctive therapy for bacterial keratitis improves long-term clinical outcomes. Design Randomized placebo-controlled double-masked clinical trial. Methods This multicenter trial compared 1.0% prednisolone sodium phosphate to placebo in the treatment of bacterial keratitis among 500 patients with culture-positive ulcers receiving 48 hours of moxifloxacin before randomization. The primary endpoint was 3 months from enrollment, and 399 patients were evaluated at 12 months. The outcomes examined were best spectacle-corrected visual acuity (BSCVA) and scar size at 12 months. Based on previous results, regression models with adjustments for baseline status and/or causative organism were used for analysis. Results No significant differences in clinical outcomes by treatment group were seen with the pre-specified regression models (BSCVA: −0.04 logMAR, 95%CI, −0.12 to 0.05, P=0.39; scar size: 0.03mm, 95% CI, −0.12 to 0.18, P=0.69). A regression model including a Nocardia-treatment arm interaction found corticosteroid use associated with a mean one-line improvement in BSCVA at 12 months among patients with non-Nocardia ulcers (−0.10 logMAR, 95%CI, −0.19 to −0.02, P=0.02). No significant difference was observed in 12-month BSCVA for Nocardia ulcers (0.18 logMAR, 95% CI, −0.04 to 0.41, P=0.16). Corticosteroids were associated with larger mean scar size at 12 months among Nocardia ulcers (0.47mm, 95% CI, 0.06 to 0.88, P=0.02) and no significant difference was identified by treatment for scar size for non-Nocardia ulcers (−0.06mm, 95%CI, −0.21 to 0.10, P=0.46). Conclusions Adjunctive topical corticosteroid therapy may be associated with improved long-term clinical outcomes in bacterial corneal ulcers not caused by Nocardia species. PMID:24315294

Dose of physical activity, physical functioning and disability risk in mobility-limited older adults: Results from the LIFE study randomized trial

PubMed Central

Guralnik, Jack M.; King, Abby C.; Pahor, Marco; McDermott, Mary M.; Tudor-Locke, Catrine; Manini, Todd M.; Glynn, Nancy W.; Marsh, Anthony P.; Axtell, Robert S.; Hsu, Fang-Chi; Rejeski, W. Jack

2017-01-01

Understanding the minimal dose of physical activity required to achieve improvement in physical functioning and reductions in disability risk is necessary to inform public health recommendations. To examine the effect of physical activity dose on changes in physical functioning and the onset of major mobility disability in The Lifestyle Interventions and Independence for Elders (LIFE) Study. We conducted a multicenter single masked randomized controlled trial that enrolled participants in 2010 and 2011 and followed them for an average of 2.6 years. 1,635 sedentary men and women aged 70–89 years who had functional limitations were randomized to a structured moderate intensity walking, resistance, and flexibility physical activity program or a health education program. Physical activity dose was assessed by 7-day accelerometry and self-report at baseline and 24 months. Outcomes included the 400 m walk gait speed, the Short Physical Performance Battery (SPPB), assessed at baseline, 6, 12, and 24 months, and onset of major mobility disability (objectively defined by loss of ability to walk 400 m in 15 min). When the physical activity arm or the entire sample were stratified by change in physical activity from baseline to 24 months, there was a dose-dependent increase in the change in gait speed and SPPB from baseline at 6, 12, and 24 months. In addition, the magnitude of change in physical activity over 24 months was related to the reduction in the onset of major mobility disability (overall P < 0.001) (highest versus the lowest quartile of physical activity change HR 0.23 ((95% CI:0.10–0.52) P = 0.001) in the physical activity arm. We observed a dose-dependent effect of objectively monitored physical activity on physical functioning and onset of major mobility disability. Relatively small increases (> 48 minutes per week) in regular physical activity participation had significant and clinically meaningful effects on these outcomes. Trial registration: ClinicalsTrials.gov NCT00116194 PMID:28820909

Dose of physical activity, physical functioning and disability risk in mobility-limited older adults: Results from the LIFE study randomized trial.

PubMed

Fielding, Roger A; Guralnik, Jack M; King, Abby C; Pahor, Marco; McDermott, Mary M; Tudor-Locke, Catrine; Manini, Todd M; Glynn, Nancy W; Marsh, Anthony P; Axtell, Robert S; Hsu, Fang-Chi; Rejeski, W Jack

2017-01-01

Understanding the minimal dose of physical activity required to achieve improvement in physical functioning and reductions in disability risk is necessary to inform public health recommendations. To examine the effect of physical activity dose on changes in physical functioning and the onset of major mobility disability in The Lifestyle Interventions and Independence for Elders (LIFE) Study. We conducted a multicenter single masked randomized controlled trial that enrolled participants in 2010 and 2011 and followed them for an average of 2.6 years. 1,635 sedentary men and women aged 70-89 years who had functional limitations were randomized to a structured moderate intensity walking, resistance, and flexibility physical activity program or a health education program. Physical activity dose was assessed by 7-day accelerometry and self-report at baseline and 24 months. Outcomes included the 400 m walk gait speed, the Short Physical Performance Battery (SPPB), assessed at baseline, 6, 12, and 24 months, and onset of major mobility disability (objectively defined by loss of ability to walk 400 m in 15 min). When the physical activity arm or the entire sample were stratified by change in physical activity from baseline to 24 months, there was a dose-dependent increase in the change in gait speed and SPPB from baseline at 6, 12, and 24 months. In addition, the magnitude of change in physical activity over 24 months was related to the reduction in the onset of major mobility disability (overall P < 0.001) (highest versus the lowest quartile of physical activity change HR 0.23 ((95% CI:0.10-0.52) P = 0.001) in the physical activity arm. We observed a dose-dependent effect of objectively monitored physical activity on physical functioning and onset of major mobility disability. Relatively small increases (> 48 minutes per week) in regular physical activity participation had significant and clinically meaningful effects on these outcomes. ClinicalsTrials.gov NCT00116194.

Asymmetric multiple information cryptosystem based on chaotic spiral phase mask and random spectrum decomposition

NASA Astrophysics Data System (ADS)

Rafiq Abuturab, Muhammad

2018-01-01

A new asymmetric multiple information cryptosystem based on chaotic spiral phase mask (CSPM) and random spectrum decomposition is put forwarded. In the proposed system, each channel of secret color image is first modulated with a CSPM and then gyrator transformed. The gyrator spectrum is randomly divided into two complex-valued masks. The same procedure is applied to multiple secret images to get their corresponding first and second complex-valued masks. Finally, first and second masks of each channel are independently added to produce first and second complex ciphertexts, respectively. The main feature of the proposed method is the different secret images encrypted by different CSPMs using different parameters as the sensitive decryption/private keys which are completely unknown to unauthorized users. Consequently, the proposed system would be resistant to potential attacks. Moreover, the CSPMs are easier to position in the decoding process owing to their own centering mark on axis focal ring. The retrieved secret images are free from cross-talk noise effects. The decryption process can be implemented by optical experiment. Numerical simulation results demonstrate the viability and security of the proposed method.

Nasal vs Oronasal CPAP for OSA Treatment: A Meta-Analysis.

PubMed

Andrade, Rafaela G S; Viana, Fernanda M; Nascimento, Juliana A; Drager, Luciano F; Moffa, Adriano; Brunoni, André R; Genta, Pedro R; Lorenzi-Filho, Geraldo

2018-03-01

Nasal CPAP is the "gold standard" treatment for OSA. However, oronasal masks are frequently used in clinical practice. The aim of this study was to perform a meta-analysis of all randomized and nonrandomized trials that compared nasal vs oronasal masks on CPAP level, residual apnea-hypopnea index (AHI), and CPAP adherence to treat OSA. The Cochrane Central Register of Controlled Trials, Medline, and Web of Science were searched for relevant studies in any language with the following terms: "sleep apnea" and "CPAP" or "sleep apnea" and "oronasal mask" or "OSA" and "oronasal CPAP" or "oronasal mask" and "adherence." Studies on CPAP treatment for OSA were included, based on the following criteria: (1) original article; (2) randomized or nonrandomized trials; and (3) comparison between nasal and oronasal CPAP including pressure level, and/or residual AHI, and/or CPAP adherence. We identified five randomized and eight nonrandomized trials (4,563 patients) that reported CPAP level and/or residual AHI and/or CPAP adherence. Overall, the random-effects meta-analysis revealed that as compared with nasal, oronasal masks were associated with a significantly higher CPAP level (Hedges' g, -0.59; 95% CI, -0.82 to -0.37; P < .001) (on average, +1.5 cm H 2 O), higher residual AHI (Hedges' g, -0.34; 95% CI, -0.52 to -0.17; P < .001) (+2.8 events/h), and a poorer adherence (Hedges' g, 0.50; 95% CI, 0.21-0.79; P = .001) (-48 min/night). Oronasal masks are associated with a higher CPAP level, higher residual AHI, and poorer adherence than nasal masks. PROSPERO database; No.: CRD42017064584; URL: https://www.crd.york.ac.uk/prospero/. Copyright © 2017 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

Neopuff T-piece resuscitator mask ventilation: Does mask leak vary with different peak inspiratory pressures in a manikin model?

PubMed

Maheshwari, Rajesh; Tracy, Mark; Hinder, Murray; Wright, Audrey

2017-08-01

The aim of this study was to compare mask leak with three different peak inspiratory pressure (PIP) settings during T-piece resuscitator (TPR; Neopuff) mask ventilation on a neonatal manikin model. Participants were neonatal unit staff members. They were instructed to provide mask ventilation with a TPR with three PIP settings (20, 30, 40 cm H 2 O) chosen in a random order. Each episode was for 2 min with 2-min rest period. Flow rate and positive end-expiratory pressure (PEEP) were kept constant. Airway pressure, inspiratory and expiratory tidal volumes, mask leak, respiratory rate and inspiratory time were recorded. Repeated measures analysis of variance was used for statistical analysis. A total of 12 749 inflations delivered by 40 participants were analysed. There were no statistically significant differences (P > 0.05) in the mask leak with the three PIP settings. No statistically significant differences were seen in respiratory rate and inspiratory time with the three PIP settings. There was a significant rise in PEEP as the PIP increased. Failure to achieve the desired PIP was observed especially at the higher settings. In a neonatal manikin model, the mask leak does not vary as a function of the PIP when the flow rate is constant. With a fixed rate and inspiratory time, there seems to be a rise in PEEP with increasing PIP. © 2017 Paediatrics and Child Health Division (The Royal Australasian College of Physicians).

Equivalence of nasal and oronasal masks during initial CPAP titration for obstructive sleep apnea syndrome.

PubMed

Teo, Ming; Amis, Terence; Lee, Sharon; Falland, Karina; Lambert, Stephen; Wheatley, John

2011-07-01

Continuous positive airway pressure (CPAP) titration studies are commonly performed using a nasal mask but some patients may prefer a full-face or oronasal mask. There is little evidence regarding the equivalence of different mask interfaces used to initiate treatment. We hypothesized that oronasal breathing when using an oronasal mask increases upper airway collapsibility and that a higher pressure may be required to maintain airway patency. We also assessed patient preferences for the 2 mask interfaces. Prospective, randomized, cross-over design with 2 consecutive CPAP titration nights. Accredited laboratory in a university hospital. Twenty-four treatment-naive subjects with obstructive sleep apnea syndrome and respiratory disturbance index of greater than 15 events per hour. CPAP titration was performed using an auto-titrating machine with randomization to a nasal or oronasal mask, followed by a second titration night using the alternate mask style. There was no significant difference in the mean pressures determined between nasal and oronasal masks, although 43% of subjects had nasal-to-oronasal mask-pressure differences of 2 cm H(2)O or more. Residual respiratory events, arousals, and measured leak were all greater with the oronasal mask. Seventy-nine percent of subjects preferred the nasal mask. Patients with obstructive sleep apnea syndrome can generally switch between nasal and oronasal masks without changing machine pressure, although there are individual differences that may be clinically significant. Measured leak is greater with the oronasal mask. Most patients with obstructive sleep apnea syndrome prefer a nasal mask as the interface for initiation of CPAP. Australian New Zealand Clinical Trials Registry (ANZCTR). ACTRN: ACTRN12611000243910. URL: http://www.ANZCTR.org.au/ACTRN12611000243910.aspx

Monaural informational masking release in children and adults

NASA Astrophysics Data System (ADS)

Buss, Emily; Hall, Joseph W.; Grose, John H.

2004-05-01

Informational masking refers to an elevation in signal threshold due to stimulus uncertainty, rather than to energetic masking. This study assessed informational masking and utilization of cues to reduce that masking in children aged 5-9 and adults. We used a manipulation introduced by Kidd et al. [J. Acoust. Soc. Am. 95, 3475-3480 (1994)] in which the signal was a train of eight consecutive tone bursts, each at 1 kHz and 60 ms in duration. Maskers were comprised of a pair of synchronous tone-burst trains whose frequencies were selected from the range spanning 0.2-5 kHz, with a protected region 851-1175 Hz. In the reference condition, where informational masking is pronounced, these maskers were eight bursts and had a fixed frequency within each interval, with new frequencies chosen randomly prior to each interval. Two conditions of masking release were tested: random frequency selection for each masker burst and a masker leading fringe of two additional 60-ms bursts. Both children and adults showed a significant informational masking effect, with children showing a larger effect. Both groups also showed significant release from masking, though initial results suggest that this may have been reduced in the youngest children. [Work supported by NIH, RO1 DC00397.

The Contrast Sensitivity of the Newborn Human Infant

PubMed Central

Brown, Angela M.; Lindsey, Delwin T.; Cammenga, Joanna G.; Giannone, Peter J.; Stenger, Michael R.

2015-01-01

Purpose. To measure the binocular contrast sensitivity (CS) of newborn infants using a fixation-and-following card procedure. Methods. The CS of 119 healthy newborn infants was measured using stimuli printed on cards under the descending method of limits (93 infants) and randomized/masked designs (26 infants). One experienced and one novice adult observer tested the infants using vertical square-wave gratings (0.06 and 0.10 cyc/deg; 20/10,000 and 20/6000 nominal Snellen equivalent); the experienced observer also tested using horizontal gratings (0.10 cyc/deg) and using the Method of Constant Stimuli while being kept unaware of the stimulus values. Results. The CS of the newborn infant was 2.0 (contrast threshold = 0.497; 95% confidence interval: 0.475–0.524) for vertically oriented gratings and 1.74 (threshold = 0.575; 95% confidence interval: 0.523–0.633) for horizontally oriented gratings (P < 0.0006). The standard deviation of infant CS was comparable to that obtained by others on adults using the Pelli-Robson chart. The two observers showed similar practice effects. Randomization of stimulus order and masking of the adult observer had no effect on CS. Conclusions. The CS of individual newborn human infants can be measured using a fixation-and-following card procedure. PMID:25564453

Prospective multicenter clinical trial to evaluate the safety and effectiveness of a new glistening-free one-piece acrylic toric intraocular lens.

PubMed

Packer, Mark; Williams, Jon I; Feinerman, Gregg; Hope, Richard S

2018-01-01

Glistening formation in the intraocular lens (IOL) optic has the potential to impact quality of vision. The enVista One-Piece Hydrophobic Acrylic Spherical IOL Model MX60 (MX60 IOL) is currently the only US Food and Drug Administration-approved IOL with a label of "no glistenings". The purpose of this prospective, multicenter, partially randomized, partially controlled, double-masked, pivotal study was to evaluate the safety and effectiveness of the enVista One-Piece Hydrophobic Acrylic MX60T Toric IOL (enVista MX60T Toric IOL). Subjects (n=191) were implanted with the enVista MX60T Toric IOL (cylinder powers 1.25, 2.00, or 2.75 D) or the parent MX60 IOL (control). Eyes within the lowest range of corneal astigmatism were randomized to receive either Toric 1.25 D IOL or control IOL in a 1:1 ratio. All subjects with corneal astigmatism requiring 2.00 or 2.75 D cylinder IOLs received toric IOLs. Rotational stability, cylinder reduction, and best-corrected distance visual acuity were primary effectiveness endpoints measured at Visit 4 (120-180 days postoperatively). Visit 4 mean absolute axis misalignment in the All Toric group was 4.68°±7.33°, and all subjects had ≤5° absolute rotation from Visit 3 to Visit 4. The 1.25 D group had significantly greater improvement in dioptric cylinder reduction ( P <0.001), percent cylinder reduction ( P <0.001), and mean uncorrected distance visual acuity ( P <0.001), compared to control at Visit 4. Most adverse events (AEs) were mild, with no serious AEs in the study eyes. The rates of cumulative AEs through Visit 4 were below International Organization for Standardization (ISO) standard 11979-7 AE rates. enVista MX60T Toric IOL is safe and effective for patients with preoperative corneal astigmatism undergoing IOL implantation.

A randomized trial comparing part-time patching with observation for children 3 to 10 years of age with intermittent exotropia.

PubMed

Cotter, Susan A; Mohney, Brian G; Chandler, Danielle L; Holmes, Jonathan M; Repka, Michael X; Melia, Michele; Wallace, David K; Beck, Roy W; Birch, Eileen E; Kraker, Raymond T; Tamkins, Susanna M; Miller, Aaron M; Sala, Nicholas A; Glaser, Stephen R

2014-12-01

To determine the effectiveness of prescribed part-time patching for treatment of intermittent exotropia (IXT) in children. Multicenter, randomized clinical trial. Three hundred fifty-eight children 3 to <11 years of age with previously untreated (except for refractive correction) IXT and near stereoacuity of 400 seconds of arc or better were enrolled. Intermittent exotropia met the following criteria: (1) IXT at distance OR constant exotropia at distance and either IXT or exophoria at near; (2) exodeviation (tropia or phoria) of at least 15 prism diopters (PD) at distance or near by prism and alternate cover test (PACT); and (3) exodeviation of at least 10 PD at distance by PACT. Participants were assigned randomly either to observation (no treatment for 6 months) or to patching for 3 hours daily for 5 months, with a 1-month washout period of no patching before the 6-month primary outcome examination. The primary outcome was deterioration at either the 3-month or the 6-month follow-up visit, defined as: (1) constant exotropia measuring at least 10 PD at distance and near by simultaneous prism and cover test, and/or (2) near stereoacuity decreased by at least 2 octaves from baseline, both assessed by a masked examiner and confirmed by a retest. Participants who were prescribed any nonrandomized treatment without first meeting either deterioration criteria also were counted as having deteriorated. Of the 324 participants (91%) completing the 6-month primary outcome examination, deterioration occurred in 10 of the 165 participants (6.1%) in the observation group (3 of these 10 started treatment without meeting deterioration criteria) and in 1 of the 159 participants (0.6%) in the part-time patching group (difference, 5.4%; lower limit of 1-sided exact 95% confidence interval, 2.0%; P = 0.004, 1-sided hypothesis test). Deterioration of previously untreated childhood IXT over a 6-month period is uncommon with or without patching treatment. Although there is a slightly lower deterioration rate with patching, both management approaches are reasonable for treating children 3 to 10 years of age with IXT. Copyright © 2014 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Cognitive outcomes of preterm infants randomized to darbepoetin, erythropoietin, or placebo.

PubMed

Ohls, Robin K; Kamath-Rayne, Beena D; Christensen, Robert D; Wiedmeier, Susan E; Rosenberg, Adam; Fuller, Janell; Lacy, Conra Backstrom; Roohi, Mahshid; Lambert, Diane K; Burnett, Jill J; Pruckler, Barbara; Peceny, Hannah; Cannon, Daniel C; Lowe, Jean R

2014-06-01

We previously reported decreased transfusions and donor exposures in preterm infants randomized to Darbepoetin (Darbe) or erythropoietin (Epo) compared with placebo. As these erythropoiesis-stimulating agents (ESAs) have shown promise as neuroprotective agents, we hypothesized improved neurodevelopmental outcomes at 18 to 22 months among infants randomized to receive ESAs. We performed a randomized, masked, multicenter study comparing Darbe (10 μg/kg, 1×/week subcutaneously), Epo (400 U/kg, 3×/week subcutaneously), and placebo (sham dosing 3×/week) given through 35 weeks' postconceptual age, with transfusions administered according to a standardized protocol. Surviving infants were evaluated at 18 to 22 months' corrected age using the Bayley Scales of Infant Development III. The primary outcome was composite cognitive score. Assessments of object permanence, anthropometrics, cerebral palsy, vision, and hearing were performed. Of the original 102 infants (946 ± 196 g, 27.7 ± 1.8 weeks' gestation), 80 (29 Epo, 27 Darbe, 24 placebo) returned for follow-up. The 3 groups were comparable for age at testing, birth weight, and gestational age. After adjustment for gender, analysis of covariance revealed significantly higher cognitive scores among Darbe (96.2 ± 7.3; mean ± SD) and Epo recipients (97.9 ± 14.3) compared with placebo recipients (88.7 ± 13.5; P = .01 vs ESA recipients) as was object permanence (P = .05). No ESA recipients had cerebral palsy, compared with 5 in the placebo group (P < .001). No differences among groups were found in visual or hearing impairment. Infants randomized to receive ESAs had better cognitive outcomes, compared with placebo recipients, at 18 to 22 months. Darbe and Epo may prove beneficial in improving long-term cognitive outcomes of preterm infants. Copyright © 2014 by the American Academy of Pediatrics.

Cognitive behavioral therapy positively affects fatigue in patients with multiple sclerosis: Results of a randomized controlled trial.

PubMed

van den Akker, Lizanne E; Beckerman, Heleen; Collette, Emma H; Twisk, Jos Wr; Bleijenberg, Gijs; Dekker, Joost; Knoop, Hans; de Groot, Vincent

2017-10-01

Fatigue is a common symptom in multiple sclerosis (MS) and often restricts societal participation. Cognitive behavioral therapy (CBT) may alleviate MS-related fatigue, but evidence in literature is inconclusive. To evaluate the effectiveness of CBT to improve MS-related fatigue and participation. In a multi-center, assessor-masked, randomized controlled trial, participants with severe MS-related fatigue were assigned to CBT or control treatment. CBT consisted of 12 individual sessions with a psychologist trained in CBT, the control treatment consisted of three consultations with a MS nurse, both delivered over 16 weeks. Assessments were at baseline, 8, 16 (i.e. post-intervention), 26, and 52 weeks post-baseline. Primary outcomes were the Checklist Individual Strength-fatigue subscale (CIS20r fatigue) and the Impact on Participation and Autonomy questionnaire (IPA). Data were analyzed according to the intention-to-treat principle, using mixed-model analysis. Between 2011 and 2014, 91 patients were randomized (CBT: n = 44; control: n = 47). Between-group analysis showed a positive post-intervention effect for CBT on CIS20r fatigue (T16: -6.7 (95% confidence interval (CI) = -10.7; -2.7) points) that diminished during follow-up (T52: 0.5 (95% CI = -3.6; 4.4)). No clinically relevant effects were found on societal participation. Severe MS-related fatigue can be reduced effectively with CBT in the short term. More research is needed on how to maintain this effect over the long term.

Hydrogel sealant versus sutures to prevent fluid egress after cataract surgery.

PubMed

Masket, Samuel; Hovanesian, John A; Levenson, Jeffrey; Tyson, Farrell; Flynn, William; Endl, Michael; Majmudar, Parag A; Modi, Satish; Chu, Ralph; Raizman, Michael B; Lane, Stephen S; Kim, Terry

2014-12-01

To evaluate the effectiveness of a hydrogel sealant versus a suture in preventing fluid egress after wound leakage in cataract surgery. Twenty-four ophthalmic clinical practices in the United States. Prospective randomized parallel-arm controlled multicenter subject-masked study. Healthy patients having uneventful clear corneal incision (CCI) cataract surgery were eligible for the study. Spontaneous and provoked fluid egress from wounds was evaluated at the time of surgery using a calibrated force gauge. Eyes with leakage were randomized to receive a hydrogel sealant (Resure) or a nylon suture at the main incision site. Incision leakage was reevaluated 1, 3, 7, and 28 days postoperatively. Of 500 eyes, 488 had leakage at the time of cataract surgery. The leak was spontaneous in 244 cases (48.8%), and 488 (97.6%) of all incisions leaked with 1.0 ounce or less of applied force. After randomization, 12 (4.1%) of 295 eyes in the sealant group and 60 (34.1%) of 176 eyes in the suture group had wound leakage with provocation (P<.0001). The overall incidence of adverse ocular events was statistically significantly lower in the sealant group than in the suture group (P<.05). In this study, 97.6% of CCIs leaked after cataract surgery. The hydrogel sealant was safe and effective and better than a suture for the intraoperative management of CCIs with leakage as seen on Seidel testing and for the prevention of postoperative fluid egress. Copyright © 2014 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

Patching vs Atropine to Treat Amblyopia in Children Aged 7 to 12 Years: A Randomized Trial

PubMed Central

2008-01-01

Objective To compare patching with atropine eye drops in the treatment of moderate amblyopia (20/40 -20/100) in children age 7 to 12 years. Methods In a randomized multi-center clinical trial, 193 children with amblyopia were randomized to weekend atropine or patching 2 hours per day of the sound eye. Main Outcome Measure Masked assessment of amblyopic eye visual acuity using the EETDRS testing protocol at 17 weeks. Results At 17 weeks, visual acuity had improved from baseline by an average of 7.6 letters in the atropine group and 8.6 letters in the patching group. The mean difference (patching minus atropine) between groups adjusted for baseline acuity was 1.2 letters (ends of complementary 1-sided 95% confidence intervals for noninferiority = -0.7 and +3.1 letters). Based on the confidence intervals this difference met the pre-specified definition for equivalence (ends of confidence intervals <5 letters). Amblyopic eye visual acuity was 20/25 or better in 15 subjects (17%) in the atropine group and 20 subjects (24%) in the patching group (difference = 7%, 95% confidence interval = -3% to 17%). Conclusions Treatment with atropine or patching leads to similar degrees of improvement in 7 to 12 year old children with moderate amblyopia. About 1 in 5 achieves 20/25 or better visual acuity in the amblyopic eye. Application to Clinical Practice Treatment of older children with unilateral amblyopia. PMID:19064841

Progressive-Addition Lenses versus Single-Vision Lenses for Slowing Progression of Myopia in Children with High Accommodative Lag and Near Esophoria

PubMed Central

2011-01-01

Purpose. To determine whether progressive-addition lenses (PALs) relative to single-vision lenses (SVLs) slow the progression of low myopia in children with high accommodative lag and near esophoria. Methods. One hundred eighteen children 8 to <12 years of age with spherical equivalent refraction (SER) from −0.75 to −2.50 D and near esophoria ≥2 PD were enrolled in this double-masked multicenter randomized trial. A key additional eligibility criterion was high accommodative lag, initially defined as at least 0.50 D (accommodative response less than 2.50 D for a 3.00-D demand) and later restricted further to at least 1.00 D. One hundred four subjects had accommodative lag of at least 1.00 D, and 14 had lag between 0.50 and 0.99 D. The children were randomized to receive either PALs with a +2.00-D addition or standard SVLs. The clinicians performing the outcome testing, as well as the children and their families, were masked to treatment group. Follow-up visits occurred every 6 months for 3 years. At annual visits, refractive error was assessed in each eye by using cycloplegic autorefraction. The main outcome measure was change from baseline to 3 years in SER by cycloplegic autorefraction. Results. The mean change in SER between baseline and the 3-year primary outcome visit was −0.87 D in the PAL group and −1.15 D in the SVL group, for a difference of 0.28 D (95% confidence interval [CI], 0.01–0.55D). Conclusions. The PALs used in this study were found to have a statistically but not clinically significant effect of slowing myopia progression in children with high accommodative lag and near esophoria. (ClinicalTrials.gov number, NCT00320593.) PMID:21282579

Facemasks, Hand Hygiene, and Influenza among Young Adults: A Randomized Intervention Trial

PubMed Central

Aiello, Allison E.; Perez, Vanessa; Coulborn, Rebecca M.; Davis, Brian M.; Uddin, Monica; Monto, Arnold S.

2012-01-01

Limited vaccine availability and the potential for resistance to antiviral medications have led to calls for establishing the efficacy of non-pharmaceutical measures for mitigating pandemic influenza. Our objective was to examine if the use of face masks and hand hygiene reduced rates of influenza-like illness (ILI) and laboratory-confirmed influenza in the natural setting. A cluster-randomized intervention trial was designed involving 1,178 young adults living in 37 residence houses in 5 university residence halls during the 2007–2008 influenza season. Participants were assigned to face mask and hand hygiene, face mask only, or control group during the study. Discrete-time survival models using generalized estimating equations to estimate intervention effects on ILI and confirmed influenza A/B infection over a 6-week study period were examined. A significant reduction in the rate of ILI was observed in weeks 3 through 6 of the study, with a maximum reduction of 75% during the final study week (rate ratio [RR] = 0.25, [95% CI, 0.07 to 0.87]). Both intervention groups compared to the control showed cumulative reductions in rates of influenza over the study period, although results did not reach statistical significance. Generalizability limited to similar settings and age groups. Face masks and hand hygiene combined may reduce the rate of ILI and confirmed influenza in community settings. These non-pharmaceutical measures should be recommended in crowded settings at the start of an influenza pandemic. Trail Registration Clinicaltrials.gov NCT00490633 PMID:22295066

Equivalence of Nasal and Oronasal Masks during Initial CPAP Titration for Obstructive Sleep Apnea Syndrome

PubMed Central

Teo, Ming; Amis, Terence; Lee, Sharon; Falland, Karina; Lambert, Stephen; Wheatley, John

2011-01-01

Study Objective: Continuous positive airway pressure (CPAP) titration studies are commonly performed using a nasal mask but some patients may prefer a full-face or oronasal mask. There is little evidence regarding the equivalence of different mask interfaces used to initiate treatment. We hypothesized that oronasal breathing when using an oronasal mask increases upper airway collapsibility and that a higher pressure may be required to maintain airway patency. We also assessed patient preferences for the 2 mask interfaces. Design: Prospective, randomized, cross-over design with 2 consecutive CPAP titration nights. Setting: Accredited laboratory in a university hospital. Patients or Participants: Twenty-four treatment-naive subjects with obstructive sleep apnea syndrome and respiratory disturbance index of greater than 15 events per hour. Interventions: CPAP titration was performed using an auto-titrating machine with randomization to a nasal or oronasal mask, followed by a second titration night using the alternate mask style. Measurements and Results: There was no significant difference in the mean pressures determined between nasal and oronasal masks, although 43% of subjects had nasal-to-oronasal mask-pressure differences of 2 cm H2O or more. Residual respiratory events, arousals, and measured leak were all greater with the oronasal mask. Seventy-nine percent of subjects preferred the nasal mask. Conclusions: Patients with obstructive sleep apnea syndrome can generally switch between nasal and oronasal masks without changing machine pressure, although there are individual differences that may be clinically significant. Measured leak is greater with the oronasal mask. Most patients with obstructive sleep apnea syndrome prefer a nasal mask as the interface for initiation of CPAP. Clinical Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR). ACTRN: ACTRN12611000243910. URL: http://www.ANZCTR.org.au/ACTRN12611000243910.aspx Citation: Teo M; Amis T; Lee S; Falland K; Lambert S; Wheatley J. Equivalence of nasal and oronasal masks during initial CPAP titration for obstructive sleep apnea syndrome. SLEEP 2011;34(7):951-955. PMID:21731145

Effectiveness of adjuvant radiotherapy in patients with oropharyngeal and floor of mouth squamous cell carcinoma and concomitant histological verification of singular ipsilateral cervical lymph node metastasis (pN1-state)--a prospective multicenter randomized controlled clinical trial using a comprehensive cohort design.

PubMed

Moergel, Maximilian; Jahn-Eimermacher, Antje; Krummenauer, Frank; Reichert, Torsten E; Wagner, Wilfried; Wendt, Thomas G; Werner, Jochen A; Al-Nawas, Bilal

2009-12-23

Modern radiotherapy plays an important role in therapy of advanced head and neck carcinomas. However, no clinical studies have been published addressing the effectiveness of postoperative radiotherapy in patients with small tumor (pT1, pT2) and concomitant ipsilateral metastasis of a single lymph node (pN1), which would provide a basis for a general treatment recommendation. The present study is a non-blinded, prospective, multi-center randomized controlled trial (RCT). As the primary clinical endpoint, overall-survival in patients receiving postoperative radiation therapy vs. patients without adjuvant therapy following curative intended surgery is compared. The aim of the study is to enroll 560 adult males and females for 1:1 randomization to one of the two treatment arms (irradiation/no irradiation). Since patients with small tumor (T1/T2) but singular lymph node metastasis are rare and the amount of patients consenting to randomization is not predictable in advance, all patients rejecting randomization will be treated as preferred and enrolled in a prospective observational study (comprehensive cohort design) after giving informed consent. This observational part of the trial will be performed with maximum consistency to the treatment and observation protocol of the RCT. Because the impact of patient preference for a certain treatment option is not calculable, parallel design of RCT and observational study may provide a maximum of evidence and efficacy for evaluation of treatment outcome. Secondary clinical endpoints are as follows: incidence and time to tumor relapse (locoregional relapse, lymph node involvement and distant metastatic spread), Quality of life as reported by EORTC (QLQ-C30 with H&N 35 module), and time from operation to orofacial rehabilitation. All tumors represent a homogeneous clinical state and therefore additional investigation of protein expression levels within resection specimen may serve for establishment of surrogate parameters of patient outcome. The inherent challenges of a rare clinical condition (pN1) and two substantially different therapy arms would limit the practicality of a classical randomized study. The concept of a Comprehensive Cohort Design combines the preference of a randomized study, with the option of careful data interpretation within an observational study. ClinicalTrials.gov: NCT00964977.

Use of face masks by non-scrubbed operating room staff: a randomized controlled trial.

PubMed

Webster, Joan; Croger, Sarah; Lister, Carolyn; Doidge, Michelle; Terry, Michael J; Jones, Ian

2010-03-01

Ambiguity remains about the effectiveness of wearing surgical face masks. The purpose of this study was to assess the impact on surgical site infections (SSIs) when non-scrubbed operating room staff did not wear surgical face masks. Eight hundred twenty-seven participants undergoing elective or emergency obstetric, gynecological, general, orthopaedic, breast or urological surgery in an Australian tertiary hospital were enrolled. Complete follow-up data were available for 811 patients (98.1%). Operating room lists were randomly allocated to a 'Mask group' (all non-scrubbed staff wore a mask) or 'No Mask group' (none of the non-scrubbed staff wore masks). The primary end point, SSI was identified using in-patient surveillance; post discharge follow-up and chart reviews. The patient was followed for up to six weeks. Overall, 83 (10.2%) surgical site infections were recorded; 46/401 (11.5%) in the Masked group and 37/410 (9.0%) in the No Mask group; odds ratio (OR) 0.77 (95% confidence interval (CI) 0.49 to 1.21), p = 0.151. Independent risk factors for surgical site infection included: any pre-operative stay (adjusted odds ratio [aOR], 0.43 (95% CI, 0.20; 0.95), high BMI aOR, 0.38 (95% CI, 0.17; 0.87), and any previous surgical site infection aOR, 0.40 (95% CI, 0.17; 0.89). Surgical site infection rates did not increase when non-scrubbed operating room personnel did not wear a face mask.

Many multicenter trials had few events per center, requiring analysis via random-effects models or GEEs.

PubMed

Kahan, Brennan C; Harhay, Michael O

2015-12-01

Adjustment for center in multicenter trials is recommended when there are between-center differences or when randomization has been stratified by center. However, common methods of analysis (such as fixed-effects, Mantel-Haenszel, or stratified Cox models) often require a large number of patients or events per center to perform well. We reviewed 206 multicenter randomized trials published in four general medical journals to assess the average number of patients and events per center and determine whether appropriate methods of analysis were used in trials with few patients or events per center. The median number of events per center/treatment arm combination for trials using a binary or survival outcome was 3 (interquartile range, 1-10). Sixteen percent of trials had less than 1 event per center/treatment combination, 50% fewer than 3, and 63% fewer than 5. Of the trials which adjusted for center using a method of analysis which requires a large number of events per center, 6% had less than 1 event per center-treatment combination, 25% fewer than 3, and 50% fewer than 5. Methods of analysis that allow for few events per center, such as random-effects models or generalized estimating equations (GEEs), were rarely used. Many multicenter trials contain few events per center. Adjustment for center using random-effects models or GEE with model-based (non-robust) standard errors may be beneficial in these scenarios. Copyright © 2015 Elsevier Inc. All rights reserved.

An Open Label, Randomized, Comparative, Parallel Group, Multicenter, Prospective, Interventional, Clinical Study to Evaluate Efficacy and Safety of "AHPL/AYTOP/0113" in Comparison with "Framycetin Sulphate Cream" in Acute Wounds.

PubMed

Nipanikar, Sanjay U; Gajare, Kamalakar V; Vaidya, Vidyadhar G; Kamthe, Amol B; Upasani, Sachin A; Kumbhar, Vidyadhar S

2017-01-01

The main objective of the present study was to assess efficacy and safety of AHPL/AYTOP/0113 cream, a polyherbal formulation in comparison with Framycetin sulphate cream in acute wounds. It was an open label, randomized, comparative, parallel group and multi-center clinical study. Total 47 subjects were randomly assigned to Group-A (AHPL/AYTOP/0113 cream) and 42 subjects were randomly assigned to Group-B (Framycetin sulphate cream). All the subjects were advised to apply study drug, thrice daily for 21 days or up to complete wound healing (whichever was earlier). All the subjects were called for follow up on days 2, 4, 7, 10, 14, 17 and 21 or up to the day of complete wound healing. Data describing quantitative measures are expressed as mean ± SD. Comparison of variables representing categorical data was performed using Chi-square test. Group-A subjects took significantly less ( P < 0.05) i.e., (mean) 7.77 days than (mean) 9.87 days of Group-B subjects for wound healing. At the end of the study, statistically significant better ( P < 0.05) results were observed in Group-A than Group-B in mean wound surface area, wound healing parameters and pain associated with wound. Excellent overall efficacy and tolerability was observed in subjects of both the groups. No adverse event or adverse drug reaction was noted in any subject of both the groups. AHPL/AYTOP/0113 cream proved to be superior to Framycetin sulphate cream in healing of acute wounds.

Forecasting Three-Month Outcomes in a Laboratory School Comparison of Mixed Amphetamine Salts Extended Release (Adderall XR) and Atomoxetine (Strattera) in School-Aged Children with ADHD

ERIC Educational Resources Information Center

Faraone, Stephen V.; Wigal, Sharon B.; Hodgkins, Paul

2007-01-01

Objective: Compare observed and forecasted efficacy of mixed amphetamine salts extended release (MAS-XR; Adderall) with atomoxetine (Strattera) in ADHD children. Method: The authors analyze data from a randomized, double-blind, multicenter, parallel-group, forced-dose-escalation laboratory school study of children ages 6 to 12 with ADHD combined…

Multicenter Safety and Immunogenicity Trial of an Attenuated Measles Vaccine for NHP

PubMed Central

Yee, JoAnn L; McChesney, Michael B; Christe, Kari L

2015-01-01

Measles is a highly contagious viral disease in NHP. The infection can range from asymptomatic to rapidly fatal, resulting in significant morbidity and mortality in captive populations. In addition to appropriate quarantine practices, restricted access, the immunization of all personnel in contact with NHP, and the wearing of protective clothing including face masks, measles immunization further reduces the infection risk. Commercially available measles vaccines are effective for use in NHP, but interruptions in their availability have prevented the implementation of ongoing, consistent vaccination programs. This need for a readily available vaccine led us to perform a broad, multicenter safety and immunogenicity study of another candidate vaccine, MVac (Serum Institute of India), a monovalent measles vaccine derived from live Edmonston–Zagreb strain virus that had been attenuated after 22 passages on human diploid cells. PMID:26473350

Comparison of the OxyMask and Venturi mask in the delivery of supplemental oxygen: Pilot study in oxygen-dependent patients

PubMed Central

Beecroft, Jaime M; Hanly, Patrick J

2006-01-01

BACKGROUND: The OxyMask (Southmedic Inc, Canada) is a new face mask for oxygen delivery that uses a small ‘diffuser’ to concentrate and direct oxygen toward the mouth and nose. The authors hypothesized that this unique design would enable the OxyMask to deliver oxygen more efficiently than a Venturi mask (Hudson RCI, USA) in patients with chronic hypoxemia. METHODS: Oxygen-dependent patients with chronic, stable respiratory disease were recruited to compare the OxyMask and Venturi mask in a randomized, single-blind, cross-over design. Baseline blood oxygen saturation (SaO2) was established breathing room air, followed in a random order by supplemental oxygen through the OxyMask or Venturi mask. Oxygen delivery was titrated to maintain SaO2 4% to 5% and 8% to 9% above baseline for two separate 30 min periods of stable breathing. Oxygen flow rate, partial pressure of inspired and expired oxygen (PO2) and carbon dioxide (PCO2), minute ventilation, heart rate, nasal and oral breathing, SaO2 and transcutaneous PCO2 were collected continuously. The study was repeated following alterations to the OxyMask design, which improved clearance of carbon dioxide. RESULTS: Thirteen patients, aged 28 to 79 years, were studied initially using the original OxyMask. Oxygen flow rate was lower, inspired PO2 was higher and expired PO2 was lower while using the OxyMask. Minute ventilation and inspired and expired PCO2 were significantly higher while using the OxyMask, whereas transcutaneous PCO2, heart rate and the ratio of nasal to oral breathing did not change significantly throughout the study. Following modification of the OxyMask, 13 additional patients, aged 18 to 79 years, were studied using the same protocol. The modified OxyMask provided a higher inspired PO2 at a lower flow rate, without evidence of carbon dioxide retention. CONCLUSIONS: Oxygen is delivered safely and more efficiently by the OxyMask than by the Venturi mask in stable oxygen-dependent patients. PMID:16896425

Psychometric functions for informational masking

NASA Astrophysics Data System (ADS)

Lutfi, Robert A.; Kistler, Doris J.; Callahan, Michael R.; Wightman, Frederic L.

2003-12-01

The term informational masking has traditionally been used to refer to elevations in signal threshold resulting from masker uncertainty. In the present study, the method of constant stimuli was used to obtain complete psychometric functions (PFs) from 44 normal-hearing listeners in conditions known to produce varying amounts of informational masking. The listener's task was to detect a pure-tone signal in the presence of a broadband noise masker (low masker uncertainty) and in the presence of multitone maskers with frequencies and amplitudes that varied at random from one presentation to the next (high masker uncertainty). Relative to the broadband noise condition, significant reductions were observed in both the slope and the upper asymptote of the PF for multitone maskers producing large amounts of informational masking. Slope was affected more for some listeners and conditions while asymptote was affected more for others; consequently, neither parameter alone was highly predictive of individual thresholds or the amount of informational masking. Mean slopes and asymptotes varied nonmonotonically with the number of masker components in a manner similar to mean thresholds, particularly when the estimated effect of energetic masking on thresholds was subtracted out. As in past studies, the threshold data were well described by a model in which trial-by-trial judgments are based on a weighted sum of levels in dB at the output of independent auditory filters. The psychometric data, however, complicated the model's interpretation in two ways: First, they suggested that, depending on the listener and condition, the weights can either reflect a fixed influence of masker components on each trial or the effect of occasionally mistaking a masker component for the signal from trial to trial. Second, they indicated that in either case the variance of the underlying decision variable as estimated from PF slope is not by itself great enough to account for the observed changes in informational masking.

Measuring and Modeling the Growth Dynamics of Self-Catalyzed GaP Nanowire Arrays.

PubMed

Oehler, Fabrice; Cattoni, Andrea; Scaccabarozzi, Andrea; Patriarche, Gilles; Glas, Frank; Harmand, Jean-Christophe

2018-02-14

The bottom-up fabrication of regular nanowire (NW) arrays on a masked substrate is technologically relevant, but the growth dynamic is rather complex due to the superposition of severe shadowing effects that vary with array pitch, NW diameter, NW height, and growth duration. By inserting GaAsP marker layers at a regular time interval during the growth of a self-catalyzed GaP NW array, we are able to retrieve precisely the time evolution of the diameter and height of a single NW. We then propose a simple numerical scheme which fully computes shadowing effects at play in infinite arrays of NWs. By confronting the simulated and experimental results, we infer that re-emission of Ga from the mask is necessary to sustain the NW growth while Ga migration on the mask must be negligible. When compared to random cosine or random uniform re-emission from the mask, the simple case of specular reflection on the mask gives the most accurate account of the Ga balance during the growth.

Face mask use and control of respiratory virus transmission in households.

PubMed

MacIntyre, C Raina; Cauchemez, Simon; Dwyer, Dominic E; Seale, Holly; Cheung, Pamela; Browne, Gary; Fasher, Michael; Wood, James; Gao, Zhanhai; Booy, Robert; Ferguson, Neil

2009-02-01

Many countries are stockpiling face masks for use as a nonpharmaceutical intervention to control virus transmission during an influenza pandemic. We conducted a prospective cluster-randomized trial comparing surgical masks, non-fit-tested P2 masks, and no masks in prevention of influenza-like illness (ILI) in households. Mask use adherence was self-reported. During the 2006 and 2007 winter seasons, 286 exposed adults from 143 households who had been exposed to a child with clinical respiratory illness were recruited. We found that adherence to mask use significantly reduced the risk for ILI-associated infection, but <50% of participants wore masks most of the time. We concluded that household use of face masks is associated with low adherence and is ineffective for controlling seasonal respiratory disease. However, during a severe pandemic when use of face masks might be greater, pandemic transmission in households could be reduced.

Evaluation Of Digital Unsharp-Mask Filtering For The Detection Of Subtle Mammographic Microcalcifications

NASA Astrophysics Data System (ADS)

Chan, Heang-Ping; Vyborny, Carl J.; MacMahon, Heber; Metz, Charles E.; Doi, Kunio; Sickles, Edward A.

1986-06-01

We have conducted a study to assess the effects of digitization and unsharp-mask filtering on the ability of observers to detect subtle microcalcifications in mammograms. Thirty-two conventional screen-film mammograms were selected from patient files by two experienced mammographers. Twelve of the mammograms contained a suspicious cluster of microcalcifications in patients who subsequently underwent biopsy. Twenty of the mammograms were normal cases which were initially interpreted as being free of clustered microcalcifications and did not demonstrate such on careful review. The mammograms were digitized with a high-quality Fuji image processing/simulation system. The system consists of two drum scanners with which an original radiograph can be digitized, processed by a minicomputer, and reconstituted on film. In this study, we employed a sampling aperture of 0.1 mm X 0.1 mm and a sampling distance of 0.1 mm. The density range from 0.2 to 2.75 was digitized to 1024 grey levels per pixel. The digitized images were printed on a single emulsion film with a display aperture having the same size as the sampling aperture. The system was carefully calibrated so that the density and contrast of a digitized image were closely matched to those of the original radiograph. Initially, we evaluated the effects of the weighting factor and the mask size of a unsharp-mask filter on the appearance of mammograms for various types of breasts. Subjective visual comparisons suggested that a mask size of 91 X 91 pixels (9.1 mm X 9.1 mm) enhances the visibility of microcalcifications without excessively increasing the high-frequency noise. Further, a density-dependent weighting factor that increases linearly from 1.5 to 3.0 in the density range of 0.2 to 2.5 enhances the contrast of microcalcifications without introducing many potentially confusing artifacts in the low-density areas. An unsharp-mask filter with these parameters was used to process the digitized mammograms. We conducted observer performance experiments to evaluate the detectability of micro-calcifications in three sets of mammograms: the original film images, unprocessed digitized images, and unsharp-masked images. Each set included the same 20 normal cases and 12 abnormal cases. A total of 5 board-certified radiologists and 4 senior radiology residents participated as observers. In the first experiment, the detectability of microcalcifications was measured for the original, unprocessed digitized, and unsharp-masked images. Each observer read all 96 films in one session with the cases arranged in a different random order. A maximum of 15 seconds was allowed to read each image. To facilitate receiver operating character-istic (ROC) analysis, each observer ranked his/her observation regarding the presence or absence of a cluster of 3 or more microcalcifications on a 5-point confidence rating scale (1=definitely no microcalcifications, 2=probably no microcalcifications; 3=microcalcifi-cations possibly present; 4=microcalcifications probably present; 5=microcalcifications definitely present). The observer identified the location of the suspected microcalci-fications when the confidence rating was 2 or greater. In the second experiment, we evaluated whether reading the unsharp-masked image and the unprocessed digitized image side by side for each case would reduce false-positive detection rates for microcalcifications and thus improve overall performance. The observer was again allowed a maximum of 15 seconds to read each pair of images and was instructed to use the unsharp-masked image for primary reading and the unprocessed digitized image for reference. The experimental setting and procedures were otherwise the same as those for the first experiment.

[Alcohol withdrawal syndrome dynamics during treatment with nooclerin (deanoli aceglumas)].

PubMed

Agibalova, T V; Buzik, O Zh; Rychkova, O V; Smyshlyaev, A V; Rumbesht, V V

2018-01-01

To study the efficacy of nooclerin (deanoli aceglumas) in alcohol withdrawal syndrome assessed by clinical and biochemical characteristics. A multicenter, open, randomized, comparative study of nooclerin in the complex treatment of alcohol withdrawal syndrome included 90 patients. The patients were randomized into nooclerin group (n=55) and control group (n=35). Nooclerin reduced alcohol withdrawal symptoms more significantly throughout the whole study period. There were significant between-group differences on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-Ar) and the Multidimensional Fatigue Inventory (МFI-20). However, patients exhibited no excessive activity. No adverse side-effects were observed.

Exploring the additivity of binaural and monaural masking release

PubMed Central

Hall, Joseph W.; Buss, Emily; Grose, John H.

2011-01-01

Experiment 1 examined comodulation masking release (CMR) for a 700-Hz tonal signal under conditions of NoSo (noise and signal interaurally in phase) and NoSπ (noise in phase, signal out of phase) stimulation. The baseline stimulus for CMR was either a single 24-Hz wide narrowband noise centered on the signal frequency [on-signal band (OSB)] or the OSB plus, a set of flanking noise bands having random envelopes. Masking noise was either gated or continuous. The CMR, defined with respect to either the OSB or the random noise baseline, was smaller for NoSπ than NoSo stimulation, particularly when the masker was continuous. Experiment 2 examined whether the same pattern of results would be obtained for a 2000-Hz signal frequency; the number of flanking bands was also manipulated (two versus eight). Results again showed smaller CMR for NoSπ than NoSo stimulation for both continuous and gated masking noise. The CMR was larger with eight than with two flanking bands, and this difference was greater for NoSo than NoSπ. The results of this study are compatible with serial mechanisms of binaural and monaural masking release, but they indicate that the combined masking release (binaural masking-level difference and CMR) falls short of being additive. PMID:21476663

Lensless digital holography with diffuse illumination through a pseudo-random phase mask.

PubMed

Bernet, Stefan; Harm, Walter; Jesacher, Alexander; Ritsch-Marte, Monika

2011-12-05

Microscopic imaging with a setup consisting of a pseudo-random phase mask, and an open CMOS camera, without an imaging objective, is demonstrated. The pseudo random phase mask acts as a diffuser for an incoming laser beam, scattering a speckle pattern to a CMOS chip, which is recorded once as a reference. A sample which is afterwards inserted somewhere in the optical beam path changes the speckle pattern. A single (non-iterative) image processing step, comparing the modified speckle pattern with the previously recorded one, generates a sharp image of the sample. After a first calibration the method works in real-time and allows quantitative imaging of complex (amplitude and phase) samples in an extended three-dimensional volume. Since no lenses are used, the method is free from lens abberations. Compared to standard inline holography the diffuse sample illumination improves the axial sectioning capability by increasing the effective numerical aperture in the illumination path, and it suppresses the undesired so-called twin images. For demonstration, a high resolution spatial light modulator (SLM) is programmed to act as the pseudo-random phase mask. We show experimental results, imaging microscopic biological samples, e.g. insects, within an extended volume at a distance of 15 cm with a transverse and longitudinal resolution of about 60 μm and 400 μm, respectively.

A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms.

PubMed

Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; Cozzolino, Vincenzo; D'Orazio, Marianna; Lupacchini, Mariacristina; Marinelli, Benedetta; Accorsi, Alessandro; Lucci, Chiara; Lancellotti, Jenny; Ballabio, Silvia; Castelli, Carola; Molteni, Daniela; Besana, Roberto; Tubaldi, Lucia; Perri, Francesco Paolo; Fusilli, Paola; D'Incecco, Carmine; Barlafante, Gina

2015-01-01

Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention. Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants.

Are orange lollies effective in preventing nausea and vomiting related to dimethyl sulfoxide? A multicenter randomized trial.

PubMed

Gonella, Silvia; Berchialla, Paola; Bruno, Benedetto; Di Giulio, Paola

2014-09-01

Nausea and vomiting (NV) related to DMSO affect patients undergoing auto-SCT despite antiemetic measures. Orange flavoring may reduce gastrointestinal symptoms. A multicenter, randomized, three-arm, open-label trial in four Italian large bone marrow transplant centers was conducted to assess the effectiveness of orange aroma in preventing NV related to DMSO. Patients were randomized to orange ice lollies, non-citrus ice lollies, and routine treatment (deep breaths) during reinfusion. Data on NV were collected up to 5 days after infusion; 69/98 patients were randomized: 23 to orange, 21 to non-citrus ice lollies, and 25 to routine treatment. Although 48 h after transplantation no differences were observed in controlled nausea (Numerical Rating Scale (NRS) 0-100, ≤25) or vomiting, significantly fewer patients had no episodes of vomiting, no antiemetic rescue therapy, and no nausea (NRS <5) in the deep breath vs lollies groups (P = 0.017). The intensity of nausea over time differed significantly between ice lollies vs routine care (P = 0.001) groups, but not between the orange and non-citrus groups (P = 0.428). The vasoconstrictive action of ice may prevent NV related to DMSO in the acute phase and reduce the need for rescue antiemetic therapy. Ice lollies offer a simple, noninvasive, and economic means for relieving nausea and vomiting related to this preservative.

Randomized crossover trial of a pressure sensing visual feedback system to improve mask fitting in noninvasive ventilation.

PubMed

Brill, Anne-Kathrin; Moghal, Mohammad; Morrell, Mary J; Simonds, Anita K

2017-10-01

A good mask fit, avoiding air leaks and pressure effects on the skin are key elements for a successful noninvasive ventilation (NIV). However, delivering practical training for NIV is challenging, and it takes time to build experience and competency. This study investigated whether a pressure sensing system with real-time visual feedback improved mask fitting. During an NIV training session, 30 healthcare professionals (14 trained in mask fitting and 16 untrained) performed two mask fittings on the same healthy volunteer in a randomized order: one using standard mask-fitting procedures and one with additional visual feedback on mask pressure on the nasal bridge. Participants were required to achieve a mask fit with low mask pressure and minimal air leak (<10 L/min). Pressure exerted on the nasal bridge, perceived comfort of mask fit and staff- confidence were measured. Compared with standard mask fitting, a lower pressure was exerted on the nasal bridge using the feedback system (71.1 ± 17.6 mm Hg vs 63.2 ± 14.6 mm Hg, P < 0.001). Both untrained and trained healthcare professionals were able to reduce the pressure on the nasal bridge (74.5 ± 21.2 mm Hg vs 66.1 ± 17.4 mm Hg, P = 0.023 and 67 ± 12.1 mm Hg vs 60 ± 10.6 mm Hg, P = 0.002, respectively) using the feedback system and self-rated confidence increased in the untrained group. Real-time visual feedback using pressure sensing technology supported healthcare professionals during mask-fitting training, resulted in a lower pressure on the skin and better mask fit for the volunteer, with increased staff confidence. © 2017 Asian Pacific Society of Respirology.

Exposure to noise during continuous positive airway pressure: influence of interfaces and delivery systems.

PubMed

Cavaliere, F; Conti, G; Costa, R; Spinazzola, G; Proietti, R; Sciuto, A; Masieri, S

2008-01-01

We measured noise intensity and perceived noisiness during continuous positive airway pressure (CPAP) performed with two interfaces (face-mask, helmet) and four delivery systems. Eight healthy volunteers received CPAP in random order with: two systems provided with a flow generator using the Venturi effect and a mechanical expiratory valve (A: Venturi, Starmed; B: Whisperflow-2, Caradyne Ltd); one 'free-flow' system provided with high flow O(2) and air flowmeters, an inspiratory gas reservoir, and a water valve (C: CF800, Drägerwerk, AG); and a standard mechanical ventilator (Servoventilator 300, Siemens-Elema). Systems A, B, and C were tested with a face-mask and a helmet at a CPAP value of 10 cm H(2)O; the mechanical ventilator was only tested with the face mask. Noise intensity was measured with a sound-level meter. After each test, participants scored noisiness on a visual analog scale (VAS). The noise levels measured ranged from 57+/-11 dBA (mechanical ventilator plus mask) to 93+/-1 and 94+/-2 dBA (systems A and B plus helmet) and were significantly affected by CPAP systems (A and B noisier than C and D) and interfaces (helmet CPAP noisier than mask CPAP). Subjective evaluation showed that systems A and B plus helmet were perceived as noisier than system C plus mask or helmet. Maximum noise levels observed in this study may potentially cause patient discomfort. Less noisy CPAP systems (not using Venturi effect) and interfaces (facial mask better than helmet) should be preferred, particularly for long or nocturnal treatments.

A cluster randomized clinical trial comparing fit‐tested and non‐fit‐tested N95 respirators to medical masks to prevent respiratory virus infection in health care workers

PubMed Central

MacIntyre, Chandini Raina; Wang, Quanyi; Cauchemez, Simon; Seale, Holly; Dwyer, Dominic E.; Yang, Peng; Shi, Weixian; Gao, Zhanhai; Pang, Xinghuo; Zhang, Yi; Wang, Xiaoli; Duan, Wei; Rahman, Bayzidur; Ferguson, Neil

2011-01-01

Please cite this paper as: MacIntyre et al. (2011) A cluster randomized clinical trial comparing fit‐tested and non‐fit‐tested N95 respirators to medical masks to prevent respiratory virus infection in health care workers. Influenza and Other Respiratory Viruses DOI: 10.1111/j.1750‐2659.2010.00198.x. Background  We compared the efficacy of medical masks, N95 respirators (fit tested and non fit tested), in health care workers (HCWs). Methods  A cluster randomized clinical trial (RCT) of 1441 HCWs in 15 Beijing hospitals was performed during the 2008/2009 winter. Participants wore masks or respirators during the entire work shift for 4 weeks. Outcomes included clinical respiratory illness (CRI), influenza‐like illness (ILI), laboratory‐confirmed respiratory virus infection and influenza. A convenience no‐mask/respirator group of 481 health workers from nine hospitals was compared. Findings  The rates of CRI (3·9% versus 6·7%), ILI (0·3% versus 0·6%), laboratory‐confirmed respiratory virus (1·4% versus 2·6%) and influenza (0·3% versus 1%) infection were consistently lower for the N95 group compared to medical masks. By intention‐to‐treat analysis, when P values were adjusted for clustering, non‐fit‐tested N95 respirators were significantly more protective than medical masks against CRI, but no other outcomes were significant. The rates of all outcomes were higher in the convenience no‐mask group compared to the intervention arms. There was no significant difference in outcomes between the N95 arms with and without fit testing. Rates of fit test failure were low. In a post hoc analysis adjusted for potential confounders, N95 masks and hospital level were significant, but medical masks, vaccination, handwashing and high‐risk procedures were not. Interpretation  Rates of infection in the medical mask group were double that in the N95 group. A benefit of respirators is suggested but would need to be confirmed by a larger trial, as this study may have been underpowered. The finding on fit testing is specific to the type of respirator used in the study and cannot be generalized to other respirators. Trial registration  Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN: ACTRN12609000257268 (http://www.anzctr.org.au). PMID:21477136

Comparing the Efficacy, Mask Leak, Patient Adherence, and Patient Preference of Three Different CPAP Interfaces to Treat Moderate-Severe Obstructive Sleep Apnea.

PubMed

Rowland, Sharn; Aiyappan, Vinod; Hennessy, Cathy; Catcheside, Peter; Chai-Coezter, Ching Li; McEvoy, R Doug; Antic, Nick A

2018-01-15

To determine if the type of continuous positive airway pressure (CPAP) mask interface influences CPAP treatment efficacy, adherence, side effects, comfort and sleep quality in patients with moderate-severe obstructive sleep apnea (OSA). This took place in a hospital-based tertiary sleep disorders unit. It is a prospective, randomized, crossover trial comparing three CPAP interfaces: nasal mask (NM), nasal mask plus chinstrap (NM-CS) and oronasal mask (ONM) each tried in random order, for 4 weeks. After each 4-week period, patient outcomes were assessed. Participants had a new diagnosis of obstructive sleep apneas. Forty-eight patients with moderate-severe OSA (32 males, mean ± standard deviation apnea-hypopnea index (AHI) 55.6 ± 21.1 events/h, age 54.9 ± 13.1 years, body mass index 35.8 ± 7.2 kg/m 2 ) were randomized. Thirty-five participants completed the full study, with complete data available for 34 patients. There was no statistically significant difference in CPAP adherence; however, residual AHI was higher with ONM than NM and NM-CS (residual AHI 7.1 ± 7.7, 4.0 ± 3.1, 4.2 ± 3.7 events/h respectively, main effect P = .001). Patient satisfaction and quality of sleep were higher with the NM and NM-CS than the ONM. Fewer leak and mask fit problems were reported with NM (all chi-square P < .05), which patients preferred over the NM-CS and ONM options (n = 22, 9 and 4 respectively, P = .001). The CPAP adherence did not differ between the three different mask interfaces but the residual AHI was lower with NM than ONM and patients reported greater mask comfort, better sleep, and overall preference for a NM. A nasal mask with or without chinstrap should be the first choice for patients with OSA referred for CPAP treatment. Registry: Australian and New Zealand Clinical Trials Registry, URL: https://www.anzctr.org.au, title: A comparison of continuous positive airway pressure (CPAP) interface in the control of leak, patient compliance and patient preference: nasal CPAP mask and chinstrap versus full face mask in patients with obstructive sleep apnoea (OSA), identifier: ACTRN12609000029291. © 2018 American Academy of Sleep Medicine

Randomized controlled trial on the effects of training in the use of closed-circuit television on reading performance.

PubMed

Burggraaff, Marloes C; van Nispen, Ruth M A; Hoeben, Frank P; Knol, Dirk L; van Rens, Ger H M B

2012-04-24

To investigate the effectiveness of training in the use of closed-circuit television (CCTV) on reading performance in visually impaired patients. In a multicenter masked randomized controlled trial, 122 patients were randomized either to a treatment group that received usual delivery instructions from the CCTV supplier combined with concise outpatient standardized training, or to a control group that received delivery instructions only. The main outcome measure was reading performance, which was obtained by measuring reading acuity, reading speed, reading errors, column-tracking time, and technical reading, approximately two weeks after patients had received their CCTV and 3 months later. Videotapes of all measurements were rated by two investigators. Training effects were analyzed with linear mixed modeling. There were no statistically significant differences in results between the treatment and control group. However, introducing a CCTV increased reading acuity (mean difference [MD] 0.93 logRAD; P < 0.01) and maximum reading speed (MD 15 wpm; P < 0.01), and decreased the number of errors (MD 0.33; P = 0.04), compared to reading without CCTV. Average reading speed (P = 0.05), number of errors (P = 0.04), and column-tracking time (P = 0.01) improved over time. Prescribing a CCTV and the delivery instructions by the supplier seemed sufficient to improve reading performance. Additional training in the use of this device did not result in further improvement. Based on these results, outpatient low-vision rehabilitation centers may consider reallocating part of the training resources into other evidence-based rehabilitation programs. (trialregister.nl number, NTR1031.).

Randomized controlled trial of the efficacy and safety of self-adhesive low-level light therapy in women with primary dysmenorrhea.

PubMed

Hong, Gi-Youn; Shin, Byung-Cheul; Park, Seong-Nam; Gu, Yun-Hee; Kim, Nam-Gyun; Park, Kyoung-Jun; Kim, Soo-Yeon; Shin, Yong-Il

2016-04-01

To evaluate the efficacy and safety of low-level light therapy in women with primary dysmenorrhea. A multicenter prospective, randomized, double-blind, placebo-controlled clinical trial including patients 18-35 years of age with primary dysmenorrhea was undertaken at two university hospitals in South Korea between October 2011 and September 2012. Patients were randomized using a computer-generated sequence to receive low-level light therapy using the Color DNA-WSF device or to receive placebo treatment with a dummy device. The severity of menstrual pain, assessed using a visual analog scale, was the primary outcome and was evaluated at baseline and during every menstrual cycle for 3 months following treatment. Patients who received more than one application of treatment (with a Color DNA-WSF or placebo device) were included in analyses. Patients and investigators were masked to the treatment assignments. Overall, 44 patients were assigned to each group. At the final study visit, the reduction in scores using a visual analog scale was significantly greater in patients who received low-level light therapy (n=41; 4.34±2.22) than among those in the control group (n=38; 1.79±1.73; P<0.001 when adjusted for age) No serious adverse events occurred. Low-level light therapy could be an effective, safe treatment modality for women with primary dysmenorrhea. Clinical Trials.gov: NCT02026206. Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study.

PubMed

Rahbar, Mohammad H; Fox, Erin E; del Junco, Deborah J; Cotton, Bryan A; Podbielski, Jeanette M; Matijevic, Nena; Cohen, Mitchell J; Schreiber, Martin A; Zhang, Jiajie; Mirhaji, Parsa; Duran, Sarah J; Reynolds, Robert J; Benjamin-Garner, Ruby; Holcomb, John B

2012-04-01

Early death due to hemorrhage is a major consequence of traumatic injury. Transfusion practices differ among hospitals and it is unknown which transfusion practices improve survival. This report describes the experience of the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study Data Coordination Center in designing and coordinating a study to examine transfusion practices at ten Level 1 trauma centers in the US. PROMMTT was a multisite prospective observational study of severely injured transfused trauma patients. The clinical sites collected real-time information on the timing and amounts of blood product infusions as well as colloids and crystalloids, vital signs, initial diagnostic and clinical laboratory tests, life saving interventions and other clinical care data. Between July 2009 and October 2010, PROMMTT screened 12,561 trauma admissions and enrolled 1245 patients who received one or more blood transfusions within 6h of Emergency Department (ED) admission. A total of 297 massive transfusions were observed over the course of the study at a combined rate of 5.0 massive transfusion patients/week. PROMMTT is the first multisite study to collect real-time prospective data on trauma patients requiring transfusion. Support from the Department of Defense and collaborative expertise from the ten participating centers helped to demonstrate the feasibility of prospective trauma transfusion studies. The observational data collected from this study will be an invaluable resource for research in trauma surgery and it will guide the design and conduct of future randomized trials. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study

PubMed Central

Rahbar, Mohammad H.; Fox, Erin E.; del Junco, Deborah J.; Cotton, Bryan A.; Podbielski, Jeanette M.; Matijevic, Nena; Cohen, Mitchell J.; Schreiber, Martin A.; Zhang, Jiajie; Mirhaji, Parsa; Duran, Sarah; Reynolds, Robert J.; Benjamin-Garner, Ruby; Holcomb, John B.

2011-01-01

Aim Early death due to hemorrhage is a major consequence of traumatic injury. Transfusion practices differ among hospitals and it is unknown which transfusion practices improve survival. This report describes the experience of the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study Data Coordination Center in designing and coordinating a study to examine transfusion practices at ten Level 1 trauma centers in the U.S. Methods PROMMTT was a multisite prospective observational study of severely injured transfused trauma patients. The clinical sites collected real-time information on the timing and amounts of blood product infusions as well as colloids and crystalloids, vital signs, initial diagnostic and clinical laboratory tests, life saving interventions and other clinical care data. Results Between July 2009 and October 2010, PROMMTT screened 12,561 trauma admissions and enrolled 1,245 patients who received one or more blood transfusions within 6 hours of ED admission. A total of 297 massive transfusions were observed over the course of the study at a combined rate of 5.0 massive transfusion patients/week. Conclusion PROMMTT is the first multisite study to collect real-time prospective data on trauma patients requiring transfusion. Support from the Department of Defense and collaborative expertise from the ten participating centers helped to demonstrate the feasibility of prospective trauma transfusion studies. The observational data collected from this study will be an invaluable resource for research in trauma surgery and it will guide the design and conduct of future randomized trials. PMID:22001613

Pseudo-orthogonalization of memory patterns for associative memory.

PubMed

Oku, Makito; Makino, Takaki; Aihara, Kazuyuki

2013-11-01

A new method for improving the storage capacity of associative memory models on a neural network is proposed. The storage capacity of the network increases in proportion to the network size in the case of random patterns, but, in general, the capacity suffers from correlation among memory patterns. Numerous solutions to this problem have been proposed so far, but their high computational cost limits their scalability. In this paper, we propose a novel and simple solution that is locally computable without any iteration. Our method involves XNOR masking of the original memory patterns with random patterns, and the masked patterns and masks are concatenated. The resulting decorrelated patterns allow higher storage capacity at the cost of the pattern length. Furthermore, the increase in the pattern length can be reduced through blockwise masking, which results in a small amount of capacity loss. Movie replay and image recognition are presented as examples to demonstrate the scalability of the proposed method.

Psychometric functions for informational masking

NASA Astrophysics Data System (ADS)

Lutfi, Robert A.; Kistler, Doris J.; Callahan, Michael R.; Wightman, Frederic L.

2003-04-01

The method of constant stimuli was used to obtain complete psychometric functions (PFs) from 44 normal-hearing listeners in conditions known to produce varying amounts of informational masking. The task was to detect a pure-tone signal in the presence of a broadband noise and in the presence of multitone maskers with frequencies and amplitudes that varied at random from one presentation to the next. Relative to the broadband noise condition, significant reductions were observed in both the slope and the upper asymptote of the PF for multitone maskers producing large amounts of informational masking. Slope was affected more for some listeners while asymptote was affected more for others. Mean slopes and asymptotes varied nonmonotonically with the number of masker components in much the same manner as mean thresholds. The results are consistent with a model that assumes trial-by-trial judgments are based on a weighted sum of dB levels at the output of independent auditory filters. For many listeners, however, the weights appear to reflect how often a nonsignal auditory filter is mistaken for the signal filter. For these listeners adaptive procedures may produce a significant bias in the estimates of threshold for conditions of informational masking. [Work supported by NIDCD.

Effect of topical application of dipyrone on dental sensitivity reduction after in-office dental bleaching: A randomized, triple-blind multicenter clinical trial.

PubMed

Rezende, Márcia; Chemin, Kaprice; Vaez, Savil Costa; Peixoto, Aline Carvalho; Rabelo, Jéssica de Freitas; Braga, Stella Sueli Lourenço; Faria-E-Silva, André Luis; Silva, Gisele Rodrigues da; Soares, Carlos José; Loguercio, Alessandro D; Reis, Alessandra

2018-05-01

Tooth sensitivity commonly occurs during and immediately after dental bleaching. The authors conducted a trial to compare tooth sensitivity after in-office bleaching after the use of either a topical dipyrone or placebo gel. A split-mouth, triple-blind, randomized, multicenter clinical trial was conducted among 120 healthy adults having teeth that were shade A2 or darker. The facial tooth surfaces of the right or left sides of the maxillary arch of each patient were randomly assigned to receive either topical dipyrone or placebo gel before 2 in-office bleaching sessions (35% hydrogen peroxide) separated by 2 weeks. Visual analog and numerical rating scales were used to record tooth sensitivity during and up to 48 hours after bleaching. Tooth color change from baseline to 1 month after bleaching was measured with shade guide and spectrophotometer measures. The primary outcome variable was absolute risk of tooth sensitivity. An intention-to-treat analysis was used to analyze data from all patients who were randomly assigned to receive the dipyrone and placebo gels. No statically significant difference was found in the absolute risk of tooth sensitivity between the dipyrone and placebo gels (83% and 90%, respectively, P = .09; relative risk, 0.92; 95% confidence interval, 0.8 to 1.0). A whitening effect was observed in both groups with no statistically significant difference (P > .05) between them. No adverse effects were observed. Topical use of dipyrone gel before tooth bleaching, at the levels used in this study, did not reduce the risk or intensity of bleaching-induced tooth sensitivity. Topical application of dipyrone gel does not reduce bleaching-induced tooth sensitivity. Copyright © 2018 American Dental Association. Published by Elsevier Inc. All rights reserved.

Randomly displaced phase distribution design and its advantage in page-data recording of Fourier transform holograms.

PubMed

Emoto, Akira; Fukuda, Takashi

2013-02-20

For Fourier transform holography, an effective random phase distribution with randomly displaced phase segments is proposed for obtaining a smooth finite optical intensity distribution in the Fourier transform plane. Since unitary phase segments are randomly distributed in-plane, the blanks give various spatial frequency components to an image, and thus smooth the spectrum. Moreover, by randomly changing the phase segment size, spike generation from the unitary phase segment size in the spectrum can be reduced significantly. As a result, a smooth spectrum including sidebands can be formed at a relatively narrow extent. The proposed phase distribution sustains the primary functions of a random phase mask for holographic-data recording and reconstruction. Therefore, this distribution is expected to find applications in high-density holographic memory systems, replacing conventional random phase mask patterns.

Effect of Kangfuxin Solution on Chemo/Radiotherapy-Induced Mucositis in Nasopharyngeal Carcinoma Patients: A Multicenter, Prospective Randomized Phase III Clinical Study

PubMed Central

Luo, Yangkun; Feng, Mei; Fan, Zixuan; Zhu, Xiaodong; Jin, Feng; Li, Rongqing; Wu, Jingbo; Yang, Xia; Jiang, Qinghua; Bai, Hongfang; Huang, Yecai; Lang, Jinyi

2016-01-01

Objective. To evaluate the efficacy and safety of Kangfuxin Solution, a pure Chinese herbal medicine, on mucositis induced by chemoradiotherapy in nasopharyngeal carcinoma patients. Methods. A randomized, parallel-group, multicenter clinical study was performed. A total of 240 patients were randomized to receive either Kangfuxin Solution (test group) or compound borax gargle (control group) during chemoradiotherapy. Oral mucositis, upper gastrointestinal mucositis, and oral pain were evaluated by Common Terminology Criteria for Adverse Events (CTCAE) v3.0 and the Verbal Rating Scale (VRS). Results. Of 240 patients enrolled, 215 were eligible for efficacy analysis. Compared with the control group, the incidence and severity of oral mucositis in the test group were significantly reduced (P = 0.01). The time to different grade of oral mucositis occurrence (grade 1, 2, or 3) was longer in test group (P < 0.01), and the accumulated radiation dose was also higher in test group comparing to the control group (P < 0.05). The test group showed lower incidence of oral pain and gastrointestinal mucositis than the control group (P < 0.01). No significant adverse events were observed. Conclusion. Kangfuxin Solution demonstrated its superiority to compound borax gargle on mucositis induced by chemoradiotherapy. Its safety is acceptable for clinical application. PMID:27375766

Comprehensive rehabilitation with integrative medicine for subacute stroke: A multicenter randomized controlled trial

PubMed Central

Fang, Jianqiao; Chen, Lifang; Ma, Ruijie; Keeler, Crystal Lynn; Shen, Laihua; Bao, Yehua; Xu, Shouyu

2016-01-01

To determine whether integrative medicine rehabilitation (IMR) that combines conventional rehabilitation (CR) with acupuncture and Chinese herbal medicine has better effects for subacute stroke than CR alone, we conducted a multicenter randomized controlled trial that involved three hospitals in China. Three hundred sixty patients with subacute stroke were randomized into IMR and CR groups. The primary outcome was the Modified Barthel Index (MBI). The secondary outcomes were the National Institutes of Health Stroke Scale (NIHSS), the Fugl-Meyer Assessment (FMA), the mini-mental state examination (MMSE), the Montreal Cognitive Assessment (MoCA), Hamilton’s Depression Scale (HAMD), and the Self-Rating Depression Scale (SDS). All variables were evaluated at week 0 (baseline), week 4 (half-way of intervention), week 8 (after treatment) and week 20 (follow-up). In comparison with the CR group, the IMR group had significantly better improvements (P < 0.01 or P < 0.05) in all the primary and secondary outcomes. There were also significantly better changes from baseline in theses outcomes in the IMR group than in the CR group (P < 0.01). A low incidence of adverse events with mild symptoms was observed in the IMR group. We conclude that conventional rehabilitation combined with integrative medicine is safe and more effective for subacute stroke rehabilitation. PMID:27174221

Phase 2a, randomized, double-blind, placebo-controlled, multicenter, parallel-group study of a H4 R-antagonist (JNJ-39758979) in Japanese adults with moderate atopic dermatitis.

PubMed

Murata, Yoko; Song, Michael; Kikuchi, Hisayuki; Hisamichi, Katsuya; Xu, Xie L; Greenspan, Andrew; Kato, Mai; Chiou, Chiun-Fang; Kato, Takeshi; Guzzo, Cynthia; Thurmond, Robin L; Ohtsuki, Mamitaro; Furue, Masutaka

2015-02-01

This trial was conducted to evaluate the safety and efficacy of the H4 R-antagonist JNJ-39758979 in adult Japanese patients with moderate atopic dermatitis (AD). Eligible patients were randomly assigned to JNJ-39758979 300 mg, 100 mg or placebo once daily for 6 weeks in this phase 2a, double-blind, multicenter, placebo-controlled study. Primary efficacy was assessed via week-6 Eczema Area and Severity Index (EASI) scores. Secondary efficacy assessments included Investigator's Global Assessment (IGA) and patient-reported outcome (PRO) pruritus assessments (Pruritus Categorical Response Scale [PCRS], Pruritus Numeric Rating Scales [PNRS], Pruritus Interference Numeric Rating Scale [PINRS] and Subject's Global Impressions of Change in Pruritus [SGICP]). Eighty-eight of 105 planned patients were randomized before the study was stopped and unblinded for safety reasons. The study did not meet the primary end-point. However, numerical improvements (i.e. decreases) in median EASI were observed with JNJ-39758979 100 mg (-3.7) and 300 mg (-3.0) versus placebo (-1.3) at week 6. Nominally significant improvements across PRO PCRS, PNRS and SGICP assessments were consistently observed, particularly with JNJ-39758979 300 mg. Safety, including adverse events (AE), was comparable between JNJ-39758979 and placebo with the exception of two patients (both receiving JNJ-39758979 300 mg) with serious AE of neutropenia, leading to premature study discontinuation. No deaths were reported. Except for neutropenia, no clinically relevant changes in laboratory values were observed. Although not conclusive, findings suggest H4 R-antagonism may be beneficial for AD, particularly in controlling pruritus. JNJ-39758979 appears to be associated with drug-induced agranulocytosis, likely an off-target effect. © 2014 Japanese Dermatological Association.

Masking of thresholds for the perception of fore-and-aft vibration of seat backrests.

PubMed

Morioka, Miyuki; Griffin, Michael J

2015-09-01

The detection of a vibration may be reduced by the presence of another vibration: a phenomenon known as 'masking'. This study investigated how the detection of one frequency of vibration is influenced by vibration at another frequency. With nine subjects, thresholds for detecting fore-and-aft backrest vibration were determined (for 4, 8, 16, and 31.5-Hz sinusoidal vibration) in the presence of a masker vibration (4-Hz random vibration, 1/3-octave bandwidth at six intensities). The masker vibration increased thresholds for perceiving vibration at each frequency by an amount that reduced with increasing difference between the frequency of the sinusoidal vibration and the frequency of the masker vibration. The 4-Hz random vibration almost completely masked 4-Hz sinusoidal vibration, partially masked 8- and 16-Hz vibration, and only slightly masked 31.5-Hz vibration. The findings might be explained by the involvement of different sensory systems and different body locations in the detection of different frequencies of vibration. Copyright © 2015 Elsevier Ltd and The Ergonomics Society. All rights reserved.

Effectiveness of adjuvant radiotherapy in patients with oropharyngeal and floor of mouth squamous cell carcinoma and concomitant histological verification of singular ipsilateral cervical lymph node metastasis (pN1-state) - A prospective multicenter randomized controlled clinical trial using a comprehensive cohort design

PubMed Central

2009-01-01

Background Modern radiotherapy plays an important role in therapy of advanced head and neck carcinomas. However, no clinical studies have been published addressing the effectiveness of postoperative radiotherapy in patients with small tumor (pT1, pT2) and concomitant ipsilateral metastasis of a single lymph node (pN1), which would provide a basis for a general treatment recommendation. Methods/Design The present study is a non-blinded, prospective, multi-center randomized controlled trial (RCT). As the primary clinical endpoint, overall-survival in patients receiving postoperative radiation therapy vs. patients without adjuvant therapy following curative intended surgery is compared. The aim of the study is to enroll 560 adult males and females for 1:1 randomization to one of the two treatment arms (irradiation/no irradiation). Since patients with small tumor (T1/T2) but singular lymph node metastasis are rare and the amount of patients consenting to randomization is not predictable in advance, all patients rejecting randomization will be treated as preferred and enrolled in a prospective observational study (comprehensive cohort design) after giving informed consent. This observational part of the trial will be performed with maximum consistency to the treatment and observation protocol of the RCT. Because the impact of patient preference for a certain treatment option is not calculable, parallel design of RCT and observational study may provide a maximum of evidence and efficacy for evaluation of treatment outcome. Secondary clinical endpoints are as follows: incidence and time to tumor relapse (locoregional relapse, lymph node involvement and distant metastatic spread), Quality of life as reported by EORTC (QLQ-C30 with H&N 35 module), and time from operation to orofacial rehabilitation. All tumors represent a homogeneous clinical state and therefore additional investigation of protein expression levels within resection specimen may serve for establishment of surrogate parameters of patient outcome. Conclusion The inherent challenges of a rare clinical condition (pN1) and two substantially different therapy arms would limit the practicality of a classical randomized study. The concept of a Comprehensive Cohort Design combines the preference of a randomized study, with the option of careful data interpretation within an observational study. Trial registration ClinicalTrials.gov: NCT00964977 PMID:20028566

Exploring the additivity of binaural and monaural masking release.

PubMed

Hall, Joseph W; Buss, Emily; Grose, John H

2011-04-01

Experiment 1 examined comodulation masking release (CMR) for a 700-Hz tonal signal under conditions of N(o)S(o) (noise and signal interaurally in phase) and N(o)S(π) (noise in phase, signal out of phase) stimulation. The baseline stimulus for CMR was either a single 24-Hz wide narrowband noise centered on the signal frequency [on-signal band (OSB)] or the OSB plus, a set of flanking noise bands having random envelopes. Masking noise was either gated or continuous. The CMR, defined with respect to either the OSB or the random noise baseline, was smaller for N(o)S(π) than N(o)S(o) stimulation, particularly when the masker was continuous. Experiment 2 examined whether the same pattern of results would be obtained for a 2000-Hz signal frequency; the number of flanking bands was also manipulated (two versus eight). Results again showed smaller CMR for N(o)S(π) than N(o)S(o) stimulation for both continuous and gated masking noise. The CMR was larger with eight than with two flanking bands, and this difference was greater for N(o)S(o) than N(o)S(π). The results of this study are compatible with serial mechanisms of binaural and monaural masking release, but they indicate that the combined masking release (binaural masking-level difference and CMR) falls short of being additive.

Factors Predicting Visual Acuity Outcome in Intermediate, Posterior, and Panuveitis: The Multicenter Uveitis Steroid Treatment (MUST) Trial.

PubMed

Kempen, John H; Van Natta, Mark L; Altaweel, Michael M; Dunn, James P; Jabs, Douglas A; Lightman, Susan L; Thorne, Jennifer E; Holbrook, Janet T

2015-12-01

To identify factors associated with best-corrected visual acuity (BCVA) presentation and 2-year outcome in 479 intermediate, posterior, and panuveitic eyes. Cohort study using randomized controlled trial data. Multicenter Uveitis Steroid Treatment (MUST) Trial masked BCVA measurements at baseline and at 2 years follow-up used gold-standard methods. Twenty-three clinical centers documented characteristics per protocol, which were evaluated as potential predictive factors for baseline BCVA and 2-year change in BCVA. Baseline factors significantly associated with reduced BCVA included age ≥50 vs <50 years; posterior vs intermediate uveitis; uveitis duration >10 vs <6 years; anterior chamber (AC) flare >grade 0; cataract; macular thickening; and exudative retinal detachment. Over 2 years, eyes better than 20/50 and 20/50 or worse at baseline improved, on average, by 1 letter (P = .52) and 10 letters (P < .001), respectively. Both treatment groups and all sites of uveitis improved similarly. Factors associated with improved BCVA included resolution of active AC cells, resolution of macular thickening, and cataract surgery in an initially cataractous eye. Factors associated with worsening BCVA included longer duration of uveitis (6-10 or >10 vs <6 years), incident AC flare, cataract at both baseline and follow-up, pseudophakia at baseline, persistence or incidence of vitreous haze, and incidence of macular thickening. Intermediate, posterior, and panuveitis have a similarly favorable prognosis with both systemic and fluocinolone acetonide implant treatment. Eyes with more prolonged/severe inflammatory damage and/or inflammatory findings initially or during follow-up have a worse visual acuity prognosis. The results indicate the value of implementing best practices in managing inflammation. Copyright © 2015 Elsevier Inc. All rights reserved.

Renal Replacement Therapy in Severe Burns: A Multicenter Observational Study.

PubMed

Chung, Kevin K; Coates, Elsa C; Hickerson, William L; Arnold-Ross, Angela L; Caruso, Daniel M; Albrecht, Marlene; Arnoldo, Brett D; Howard, Christina; Johnson, Laura S; McLawhorn, Melissa M; Friedman, Bruce; Sprague, Amy M; Mosier, Michael J; Conrad, Peggie F; Smith, David J; Karlnoski, Rachel A; Aden, James K; Mann-Salinas, Elizabeth A; Wolf, Steven E

2018-06-20

Acute kidney injury (AKI) after severe burns is historically associated with a high mortality. Over the past two decades, various modes of renal replacement therapy (RRT) have been utilized in this population. The purpose of this multicenter study was to evaluate demographic, treatment and outcomes data among severe burn patients treated with RRT collectively at various burn centers around the United States. After institutional review board approval, a multicenter observational study was conducted. All adult patients 18 or older, admitted with severe burns who were placed on RRT for acute indications but not randomized into a concurrently enrolling interventional trial were included. Across 8 participating burn centers, 171 subjects were enrolled during a 4 year period. Complete data was available in 170 subjects with a mean age of 51±17, percent total body surface area (TBSA) burn of 38±26% and Injury Severity Score of 27±21. 80% of subjects were male and 34% were diagnosed with smoke inhalation injury. The preferred mode of therapy was continuous venovenous hemofiltration at a mean delivered dose of 37±19 (mL/kg/hr) and a treatment duration of 13±24 days. Overall, in hospital mortality was 50%. Among survivors, 21% required RRT upon discharge from the hospital while 9% continued to require RRT 6 months after discharge. This is the first multi-center cohort of burn patients who underwent RRT reported to date. Overall mortality is comparable to other critically ill populations who undergo RRT. Most patients who survive to discharge eventually recover renal function.

The effect of physician and patient education when combined with vardenafil treatment in Canadian males with erectile dysfunction: an open-label, factorial-designed, cluster-randomized clinical trial.

PubMed

Brock, Gerald; Carrier, Serge; Alarie, Pierre; Pommerville, Peter; Casey, Richard; Harris, Stewart; Ward, Richard

2008-03-01

Studies evaluating the effect of education on treatment success with phosphodiesterase type 5 (PDE5) inhibitor therapy in men with erectile dysfunction (ED) are limited. Additional education of the primary care physician (PCP) and the patient are thought to optimize the treatment of ED. To assess the impact of education of the PCP or of the patient in the treatment of ED with vardenafil relative to usual care. In this 12-week, open-label, multicenter, factorial-designed, cluster-randomized Canadian study, 1,029 patients with ED were enrolled into four different education groups: usual care, patient education, PCP education, and both PCP and patient education. All groups started on vardenafil 10 mg, with the option to titrate at weeks 4 and 8. The primary efficacy measure was the difference at week 4 last observation carried forward (LOCF) in the overall improvement in erectile function (EF) as measured by the Global Assessment Question (GAQ), while on background vardenafil, between those receiving education vs. those who did not. Other secondary assessments included responses to diary questions regarding penetration (sexual encounter profile, SEP2) and erection maintenance (SEP3), and to questionnaires regarding treatment satisfaction (Erectile Dysfunction Inventory of Treatment Satisfaction [EDITS]). A total of 956 patients were included in the intent-to-treat population. Mean baseline International Index of Erectile Function-EF domain score was 13. GAQ response rates at week 4 LOCF were high (>80%) for all groups, regardless of the education given. Mean per patient SEP2 and SEP3 rates at week 12 LOCF were 86-89% and 79-83%, respectively. In an exploratory analysis, a positive relationship between GAQ responses and EDITS scores was observed (P < or = 0.0007). Vardenafil was generally well tolerated. In men with moderate ED, vardenafil led to high success rates and satisfaction regardless of the education given. The benefits of education for PCP and patients in Canada were possibly masked by a ceiling effect in this study population.

Effects of a Clinician Referral and Exercise Program for Men Who Have Completed Active Treatment for Prostate Cancer: A Multicenter Cluster Randomized Controlled Trial (ENGAGE)

PubMed Central

Livingston, Patricia M; Craike, Melinda J; Salmon, Jo; Courneya, Kerry S; Gaskin, Cadeyrn J; Fraser, Steve F; Mohebbi, Mohammadreza; Broadbent, Suzanne; Botti, Mari; Kent, Bridie

2015-01-01

BACKGROUND The purpose of this study was to determine the efficacy of a clinician referral and exercise program in improving exercise levels and quality of life for men with prostate cancer. METHODS This was a multicenter cluster randomized controlled trial in Melbourne, Australia comprising 15 clinicians: 8 clinicians were randomized to refer eligible participants (n = 54) to a 12-week exercise program comprising 2 supervised gym sessions and 1 home-based session per week, and 7 clinicians were randomized to follow usual care (n = 93). The primary outcome was self-reported physical activity; the secondary outcomes were quality of life, anxiety, and symptoms of depression. RESULTS A significant intervention effect was observed for vigorous-intensity exercise (effect size: Cohen's d, 0.46; 95% confidence interval [CI], 0.09-0.82; P = .010) but not for combined moderate and vigorous exercise levels (effect size: d, 0.08; 95% CI, −0.28 to 0.45; P = .48). Significant intervention effects were also observed for meeting exercise guidelines (≥150 min/wk; odds ratio, 3.9; 95% CI, 1.9-7.8; P = .002); positive intervention effects were observed in the intervention group for cognitive functioning (effect size: d, 0.34; 95% CI, −0.02 to 0.70; P = .06) and depression symptoms (effect size: d, −0.35; 95% CI, −0.71 to 0.02; P = .06). Eighty percent of participants reported that the clinician's referral influenced their decision to participate in the exercise program. CONCLUSIONS The clinician referral and 12-week exercise program significantly improved vigorous exercise levels and had a positive impact on mental health outcomes for men living with prostate cancer. Further research is needed to determine the sustainability of the exercise program and its generalizability to other cancer populations. Cancer 2015;121:2646–2654. © 2015 American Cancer Society. PMID:25877784

A Multicenter, Prospective, Randomized Controlled Trial Evaluating the Efficacy of Rectal Diclofenac and Sublingual Nitroglycerin as a Combined Prophylactic Treatment for Post-ERCP Pancreatitis.

PubMed

Tomoda, Takeshi; Kato, Hironari; Mizukawa, Sho; Muro, Shinichiro; Akimoto, Yutaka; Uchida, Daisuke; Matsumoto, Kazuyuki; Yamamoto, Naoki; Horiguchi, Shigeru; Tsutsumi, Koichiro; Okada, Hiroyuki

2016-01-01

Acute pancreatitis is the major complication of endoscopic retrograde cholangiopancreatography (ERCP). A preliminary research suggested that the administration of nonsteroidal anti-inflammatory drugs (NSAIDs) with nitroglycerin might reduce the incidence of post-ERCP pancreatitis (PEP) more effectively than NSAIDs alone. We conduct a two-arm, multicenter, prospective, randomized, superiority trial to evaluate the additional effect of nitroglycerin for prevention of PEP. A total of 900 patients randomly receive 50 mg diclofenac suppository either alone or with 5 mg isosorbide dinitrate sublingual tablet. The primary endpoint is the occurrence of PEP. This study will clarify whether NSAIDs plus nitroglycerin can prevent PEP.

An ex vivo human aqueous humor-concentration comparison of two commercial bromfenac formulations

PubMed Central

Walters, Thomas R; Smyth-Medina, Robert J; Cockrum, Paul C

2018-01-01

Purpose The purpose of this study was to quantify the concentration of bromfenac in the aqueous humor utilizing high-performance liquid chromatography mass spectrometry between two commercial nonsteroidal anti-inflammatory drugs, using aqueous humor concentrations to characterize pharmacokinetic proportional differences between 0.075% bromfenac ophthalmic solution in DuraSite (BromSite®) and 0.09% bromfenac ophthalmic solution (Bromday®). Methods In this multicenter, randomized, double-masked, two-arm, parallel-group, comparative, Phase II clinical trial, subjects were assigned to receive bromfenac in DuraSite or bromfenac ophthalmic solution in a 1:1 ratio. One drop of the masked test article was instilled into the study eye once a day for 2 days prior to and 3 hours prior (last instillation) to the subject’s cataract surgery. Aqueous humor samples were collected upon initial cataract incision for analysis of bromfenac levels. The primary end point was aqueous humor concentration of bromfenac at Day 3, at the initiation of cataract surgery. Aqueous humor samples were collected and analyzed for bromfenac levels. Results A total of 60 subjects completed the study, 30 in each group. The mean bromfenac aqueous humor concentration in subjects who received bromfenac in DuraSite was more than twice (49.33±41.87 ng/mL, P=0.004) that of subjects who received bromfenac ophthalmic solution (23.65±16.31 ng/mL) after three doses. Conclusion Mean bromfenac aqueous humor concentration in subjects receiving the DuraSite-containing bromfenac in DuraSite (0.075%) was significantly higher compared to subjects receiving bromfenac ophthalmic solution (0.09%) after 3 days of dosing. PMID:29849449

Randomized Comparison of Systemic Anti-inflammatory Therapy Versus Fluocinolone Acetonide Implant for Intermediate, Posterior and Panuveitis: The Multicenter Uveitis Steroid Treatment Trial

PubMed Central

Kempen, John H.; Altaweel, Michael M.; Holbrook, Janet T.; Jabs, Douglas A.; Louis, Thomas A.; Sugar, Elizabeth A.; Thorne, Jennifer E.

2011-01-01

Objective To compare the relative effectiveness of systemic corticosteroids plus immunosuppression when indicated (systemic therapy) versus fluocinolone acetonide implant (implant therapy) for non-infectious intermediate, posterior or panuveitis (uveitis). Design Randomized controlled parallel superiority trial. Participants Patients with active/recently active uveitis. Methods Participants were randomized (allocation ratio 1:1) to systemic or implant therapy at 23 centers (three countries). Implant-assigned participants with bilateral uveitis were assigned to have each eye that warranted study treatment implanted. Treatment-outcome associations were analyzed by assigned treatment for all eyes with uveitis. Main Outcome Measures Masked examiners measured the primary outcome: change in best-corrected visual acuity from baseline. Secondary outcomes included patient-reported quality of life (QoL), ophthalmologist-graded uveitis activity, and local and systemic complications of uveitis or therapy. Reading Center graders and glaucoma specialists assessing ocular complications were masked. Participants, ophthalmologists, and coordinators were unmasked. Results Among 255 patients randomized to implant and systemic therapy (479 eyes with uveitis), evaluating changes from baseline to 24 months, the implant and systemic therapy groups respectively had +6.0 vs. +3.2 letters' improvement in visual acuity (p=0.16, 95% confidence interval on difference in improvement between groups: −1.2 to +6.7 letters, positive values favoring implant), +11.4 vs. +6.8 units' vision-related QoL improvement (p=0.043), +0.02 vs. −0.02 change in EuroQol-EQ5D health utility (p=0.060), and 12% vs. 29% had active uveitis (p=0.001). Over 24 months, implant-assigned eyes had a higher risk of cataract surgery (80%, hazard ratio (HR) = 3.3, p<0.0001), treatment for elevated intraocular pressure (61%, HR=4.2, p<0.0001), and glaucoma (17%, HR = 4.2, p=0.0008). Systemic-assigned patients had more prescription-requiring infections (0.60 vs. 0.36/person-year, p=0.034), without notable long-term consequences; systemic adverse outcomes otherwise were unusual in both groups, with minimal differences between groups. Conclusion In each treatment group, mean visual acuity improved over 24 months, with neither approach superior to a degree detectable with the study's power. Therefore, the specific advantages and disadvantages identified should dictate selection between the alternative treatments in consideration of individual patients' particular circumstances. Systemic therapy with aggressive use of corticosteroid-sparing immunosuppression was well-tolerated, suggesting that this approach is reasonably safe for local and systemic inflammatory disorders. PMID:21840602

[Impacts of different methods in laryngeal mask airway positioning on the airway management of elderly patients with general anesthesia].

PubMed

Yan, F; Li, J; Wang, H J; Yang, X; Yang, J B; Tu, X J

2018-05-15

Objective: By observing the clinical effect of ultrasound, fiberoptic bronchoscopy and traditional standard in positioning the general anesthesia of laryngeal mask ventilation in elderly patients, the superiority of laryngeal mask positioning with visualization technique of ultrasound and fiberoptic bronchoscope on airway management in elderly patients with general anesthesia was analyzed. Methods: One hundred and twenty cases of elderly patients with general anesthesia of laryngeal mask ventilation from the People's Hospital of Yuyao city from October 2016 to October 2017 were selected and randomly divided into 3 groups( n =40)according to American Society of Anesthesiologists (ASA) grading criteria Ⅰ-Ⅲ. Group A: traditional standard positioning laryngeal mask group. Group B: fiberoptic bronchoscope positioning laryngeal mask group. Group C: ultrasound positioning laryngeal mask group. The general information of sex ratio of male and female, mass, and height, and operation type, operation duration, anaesthesia duration, and modified Mallampati grade were observed and compared among the three groups. The number of successful laryngeal mask ventilation after laryngeal mask placement in 3 groups was observed, the laryngeal mask placement time (T(0)) and the normal ventilation time after adjustment (T(1)) in each group were recorded, and the first success rate of laryngeal mask placement, the success rate after adjusting the positioning, and the success rate of re-placement were calculated. Moreover, the mean peak airway pressure at 5 min after operation, the minimum intrathecal injection gas for minimum ventilation (V(min)), the minimum laryngeal mask intravesical pressure (ICP(min)), and the lowest air pressure for oral and pharyngeal leakage (OLP(min)) were recorded. The airway seal pressure (OLP(60)) and the volume of gas injection (V(60)) when the intravesical pressure was 60 cmH(2)O (1 cmH(2)O=0.098 kPa) were used to record the incidence of postoperative laryngeal mask bleeding, cough, nausea and vomiting, and the incidence of pharyngalgia, odynophagia, hoarseness and other related complications after 24 hours of the operation. Results: There was no significant difference in general information, airway evaluation and anesthesia operation among the three groups (all P >0.05). The incidence of intraoperative laryngeal mask bleeding in group B and C was 7.9% and 2.6% respectively, the incidence of odynophagia at 24 hours after operation was 5.3% and 0 respectively, and the incidence of pharyngalgia and hoarseness was 18.4% and 7.9% respectively, less than that in group A (24.2%, 12.1% and 36.3%). The difference was statistically significant (χ(2)=8.900, 6.880, 9.000, P <0.05). The success rate of adjustment and positioning after the placement of laryngeal mask was 84.2% and 94.7% respectively in group B and C, higher than that in group A of 72.7%, and the difference was statistically significant (χ(2)=6.500, P <0.05). The lowest laryngeal mask intralaryngeal pressure for ventilation in group B and C was (35.39±4.67) cmH(2)O and (32.61±3.22) cmH(2)O, lower than that in group A of (39.30 ± 5.93) cmH(2)O, the intralaryngeal pressure was 60 cmH(2)O, and the airway seal pressure was (25.82±4.48) cmH(2)O and (28.34±6.99) cmH(2)O, higher than that in group A of (22.45±4.98) cmH(2)O, which was significantly different ( F =18.200, 9.720, P <0.05). Conclusions: In elderly patients with general anesthesia, it is feasible to manage the airway by ultrasound or fiberoptic bronchoscopy with laryngeal mask. Ultrasound positioning laryngeal mask improves the accuracy of the intraoperative ventilation, and reduces the incidence of postoperative airway related complications.

The impact of written information and counseling (WOMAN-PRO II Program) on symptom outcomes in women with vulvar neoplasia: A multicenter randomized controlled phase II study.

PubMed

Raphaelis, Silvia; Mayer, Hanna; Ott, Stefan; Mueller, Michael D; Steiner, Enikö; Joura, Elmar; Senn, Beate

2017-07-01

To determine whether written information and/or counseling based on the WOMAN-PRO II Program decreases symptom prevalence in women with vulvar neoplasia by a clinically relevant degree, and to explore the differences between the 2 interventions in symptom prevalence, symptom distress prevalence, and symptom experience. A multicenter randomized controlled parallel-group phase II trial with 2 interventions provided to patients after the initial diagnosis was performed in Austria and Switzerland. Women randomized to written information received a predefined set of leaflets concerning wound care and available healthcare services. Women allocated to counseling were additionally provided with 5 consultations by an Advanced Practice Nurse (APN) between the initial diagnosis and 6months post-surgery that focused on symptom management, utilization of healthcare services, and health-related decision-making. Symptom outcomes were simultaneously measured 5 times to the counseling time points. A total of 49 women with vulvar neoplasia participated in the study. Symptom prevalence decreased in women with counseling by a clinically relevant degree, but not in women with written information. Sporadically, significant differences between the 2 interventions could be observed in individual items, but not in the total scales or subscales of the symptom outcomes. The results indicate that counseling may reduce symptom prevalence in women with vulvar neoplasia by a clinically relevant extent. The observed group differences between the 2 interventions slightly favor counseling over written information. The results justify testing the benefit of counseling thoroughly in a comparative phase III trial. Copyright © 2017 Elsevier Inc. All rights reserved.

The efficacy of three different mask styles on a PAP titration night.

PubMed

Ebben, Matthew R; Oyegbile, Temitayo; Pollak, Charles P

2012-06-01

This study compared the efficacy of three different masks, nasal pillows, nasal masks and full face (oronasal) masks, during a single night of titration with continuous positive airway pressure (CPAP). Fifty five subjects that included men (n=33) and women (n=22) were randomly assigned to one of three masks and underwent a routine titration with incremental CPAP applied through the different masks. CPAP applied through the nasal pillows and nasal mask was equally effective in treating mild, moderate, and severe sleep apnea. However, CPAP applied through the oronasal mask required a significantly higher pressure compared to nasal masks to treat moderately severe (2.8 cm of H(2)O ± 2.1 SD) and severe (6.0 cm of H(2)O ± 3.2 SD) obstructive sleep apnea. CPAP applied with either nasal mask was effective in treating mild, moderate, and severe sleep apnea. The oronasal mask required significantly higher pressures in subjects with moderate to severe disease. Therefore, when changing from a nasal to an oronasal mask, a repeat titration is required to ensure effective treatment of sleep apnea, especially in patients with moderate to severe disease. Copyright © 2012 Elsevier B.V. All rights reserved.

A Multicenter, Randomized, Controlled Trial of Osteopathic Manipulative Treatment on Preterms

PubMed Central

Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; Cozzolino, Vincenzo; D’Orazio, Marianna; Lupacchini, Mariacristina; Marinelli, Benedetta; Accorsi, Alessandro; Lucci, Chiara; Lancellotti, Jenny; Ballabio, Silvia; Castelli, Carola; Molteni, Daniela; Besana, Roberto; Tubaldi, Lucia; Perri, Francesco Paolo; Fusilli, Paola; D’Incecco, Carmine; Barlafante, Gina

2015-01-01

Background Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. Materials and Methods The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. Results A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention. Conclusions Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants. PMID:25974071

Safety and Efficacy of the ACE-Inhibitor Ramipril in Alport Syndrome: The Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase III EARLY PRO-TECT Alport Trial in Pediatric Patients.

PubMed

Gross, Oliver; Friede, Tim; Hilgers, Reinhard; Görlitz, Anke; Gavénis, Karsten; Ahmed, Raees; Dürr, Ulrike

2012-01-01

Introduction. Retrospective observational data show that ACE-inhibitor therapy delays renal failure and improves life expectancy in Alport patients with proteinuria. The EARLY PRO-TECT Alport trial assesses the safety and efficacy of early therapy onset with ramipril in pediatric Alport patients. Methods and analysis. This double-blind, randomized, placebo-controlled, multicenter phase III trial (NCT01485978; EudraCT-number 2010-024300-10) includes 120 pediatric patients aged 24 months to 18 years with early stages of Alport syndrome (isolated hematuria or microalbuminuria). From March 2012, up to 80 patients will be randomized 1:1 to ramipril or placebo. In the event of disease progression during 3-year treatment, patients are unblinded and ramipril is initiated, if applicable. Approximately 40 patients receive open-label ramipril contributing to the safety database. Primary end-points are "time to progression to next disease level" and "incidence of adverse drug events before disease progression." Treatment effect estimates from the randomized comparison and Alport registry data will be combined in supportive analyses to maximize evidence. Conclusion. Without this trial, ACE inhibitors may become standard off-label treatment in Alport syndrome without satisfactory evidence base. The results are expected to be of relevance for therapy of all pediatric patients with kidney disease, and the trial protocol might serve as a model for other rare pediatric glomerulopathies.

DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity (DUTCH PEERS): rationale and study design of a randomized multicenter trial in a Dutch all-comers population.

PubMed

Tandjung, Kenneth; Basalus, Mounir W Z; Sen, Hanim; Jessurun, Gillian A J; Danse, Peter W; Stoel, Martin; Linssen, Gerard C M; Derks, Anita; van Loenhout, Ton T; Nienhuis, Mark B; Hautvast, Raymond W M; von Birgelen, Clemens

2012-04-01

Drug-eluting stents (DES) are increasingly used for the treatment of coronary artery disease. An optimized DES performance is desirable to successfully treat various challenging coronary lesions in a broad population of patients. In response to this demand, third-generation DES with an improved deliverability were developed. Promus Element (Boston Scientific, Natick, MA) and Resolute Integrity (Medtronic Vascular, Santa Rosa, CA) are 2 novel third-generation DES for which limited clinical data are available. Accordingly, we designed the current multicenter study to investigate in an all-comers population whether the clinical outcome is similar after stenting with Promus Element versus Resolute Integrity. DUTCH PEERS is a multicenter, prospective, single-blinded, randomized trial in a Dutch all-comers population. Patients with all clinical syndromes who require percutaneous coronary interventions with DES implantation are eligible. In these patients, the type of DES implanted will be randomized in a 1:1 ratio between Resolute Integrity versus Promus Element. The trial is powered based on a noninferiority hypothesis. For each stent arm, 894 patients will be enrolled, resulting in a total study population of 1,788 patients. The primary end point is the incidence of target vessel failure at 1-year follow-up. DUTCH PEERS is the first randomized multicenter trial with a head-to-head comparison of Promus Element and Resolute Integrity to investigate the safety and efficacy of these third-generation DES. Copyright © 2012 Mosby, Inc. All rights reserved.

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

Safety and Tolerance Evaluation of Milk Fat Globule Membrane-Enriched Infant Formulas: A Randomized Controlled Multicenter Non-Inferiority Trial in Healthy Term Infants

PubMed Central

Billeaud, Claude; Puccio, Giuseppe; Saliba, Elie; Guillois, Bernard; Vaysse, Carole; Pecquet, Sophie; Steenhout, Philippe

2014-01-01

OBJECTIVE This multicenter non-inferiority study evaluated the safety of infant formulas enriched with bovine milk fat globule membrane (MFGM) fractions. METHODS Healthy, full-term infants (n = 119) age ≤14 days were randomized to standard infant formula (control), standard formula enriched with a lipid-rich MFGM fraction (MFGM-L), or standard formula enriched with a protein-rich MFGM fraction (MFGM-P). Primary outcome was mean weight gain per day from enrollment to age 4 months (non-inferiority margin: −3.0 g/day). Secondary (length, head circumference, tolerability, morbidity, adverse events) and exploratory (phospholipids, metabolic markers, immune markers) outcomes were also evaluated. RESULTS Weight gain was non-inferior in the MFGM-L and MFGM-P groups compared with the control group. Among secondary and exploratory outcomes, few between-group differences were observed. Formula tolerance rates were high (>94%) in all groups. Adverse event and morbidity rates were similar across groups except for a higher rate of eczema in the MFGM-P group (13.9% vs control [3.5%], MFGM-L [1.4%]). CONCLUSION Both MFGM-enriched formulas met the primary safety endpoint of non-inferiority in weight gain and were generally well tolerated, although a higher rate of eczema was observed in the MFGM-P group. PMID:25452707

[Effect of a surgical mask on six minute walking distance].

PubMed

Person, E; Lemercier, C; Royer, A; Reychler, G

2018-03-01

Six minutes walking test (6MWT) is regularly used in pulmonology. To minimize the risk of cross-infection, some patients must wear surgical mask at rest and sometimes during exercise. To evaluate the effect of wearing a surgical mask during 6MWT in healthy subjects. It is a prospective study on 44 healthy subjects. After a first 6MWT for training, they performed randomly two 6MWT: with or without a surgical mask. Distance and dyspnea, heart rate and saturation variations were recorded. Distance was not modified by the mask (P=0.99). Dyspnea variation was significantly higher with surgical mask (+5.6 vs. +4.6; P<0.001) and the difference was clinically relevant. No difference was found for the variation of other parameters. Wearing a surgical mask modifies significantly and clinically dyspnea without influencing walked distance. Copyright © 2017 SPLF. Published by Elsevier Masson SAS. All rights reserved.

Emixustat Hydrochloride for Geographic Atrophy Secondary to Age-Related Macular Degeneration: A Randomized Clinical Trial.

PubMed

Rosenfeld, Philip J; Dugel, Pravin U; Holz, Frank G; Heier, Jeffrey S; Pearlman, Joel A; Novack, Roger L; Csaky, Karl G; Koester, John M; Gregory, Jeffrey K; Kubota, Ryo

2018-04-28

To determine whether emixustat hydrochloride (emixustat) reduces the rate of enlargement of geographic atrophy (GA) compared with placebo in subjects with age-related macular degeneration (AMD) and to evaluate the safety and tolerability of emixustat over 24 months of treatment. Multicenter, randomized, double-masked, placebo-controlled, phase 2b/3 clinical trial. Patients with GA secondary to AMD, a visual acuity score of at least 35 letters, and GA with a total area of 1.25 to 18 mm 2 were enrolled. Subjects were randomized (1:1:1:1) to emixustat 2.5 mg, 5 mg, 10 mg, or placebo, administered orally once daily for 24 months. Visits included screening, baseline, and months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, and 25. The primary efficacy end point was the mean annual growth rate of total GA area in the study eye, as measured by a central reading center using fundus autofluorescence (FAF) images. The change from baseline in normal luminance best-corrected visual acuity (NL-BCVA) was a secondary efficacy end point. Of 508 randomized subjects, 320 completed the study. Demographics and baseline characteristics were comparable between treatment groups. On average, GA lesions in the study eye grew at a similar rate in each group (emixustat: 1.69 to 1.84 mm 2 /year; placebo: 1.69 mm 2 /year; P ≥ 0.81). Changes in NL-BCVA were also comparable between groups. Subjects with a larger low luminance deficit (LLD) at baseline (≥20 letters) demonstrated a more rapid growth of GA over 24 months. No relationship was observed between the risk-allele status of the AMD-associated single-nucleotide polymorphisms tested and the growth rate of GA. The most common adverse events in emixustat-treated subjects were delayed dark adaptation (55%), chromatopsia (18%), visual impairment (15%), and erythropsia (15%). Emixustat did not reduce the growth rate of GA in AMD. The most common adverse events were ocular in nature and likely related to the drug's mechanism of action. Data gained from this study over a 2-year period add to the understanding of the natural history of GA and the baseline characteristics affecting the growth rate of GA. Copyright © 2018 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

A randomized double-masked study to compare the ocular safety, tolerability, and efficacy of bromfenac 0.075% compared with vehicle in cataract surgery subjects

PubMed Central

Hosseini, Kamran; Walters, Thomas; DaVanzo, Robert; Lindstrom, Richard L

2016-01-01

Purpose The aim of this study was to evaluate the safety, tolerability, and efficacy of a low-dose version of bromfenac 0.075% in DuraSite® (bromfenac 0.075%) compared with DuraSite® vehicle (vehicle) alone for the treatment of postoperative inflammation and ocular pain after cataract surgery. Methods A multicenter, double-masked, vehicle-controlled, parallel-group clinical trial of 240 subjects randomized in a 2:1 ratio to bromfenac 0.075% or vehicle was conducted. Subjects were dosed BID beginning 1 day before the cataract surgery, the day of surgery, and 14 days after surgery. A slit lamp biomicroscopy examination was performed to evaluate the signs of inflammation, including anterior chamber cells (ACC) and anterior chamber flare (ACF). The primary efficacy variable was the proportion of subjects with an ACC grade of 0 at Day 15. Secondary efficacy endpoints included the proportion of subjects who achieved a pain score of 0 at each postsurgical visual analog scale (VAS) assessment and the proportion of subjects with an ACF grade of 0 at Day 15. Results At Day 15, proportionally more subjects in the bromfenac 0.075% group than in the vehicle group had an ACC grade of 0 (57.1% vs 18.8%, respectively; P<0.001). At each of the postsurgical time points (Days 1, 8, 15, and 29), proportionally more bromfenac 0.075%-treated subjects (76.8%, 90.5%, 92.9%, and 85.1%, respectively) had no pain (a VAS score of 0) compared with the vehicle-treated subjects (48.2%, 38.8%, 42.4%, and 47.1%, respectively), and at each time point, these differences in proportions were statistically significant (P<0.001). More subjects in the bromfenac 0.075% group had complete ACF resolution (151/167; 90.4%) compared to those in the vehicle group (54/85; 63.5%). There were no new safety signals reported. Conclusion Bromfenac 0.075% in DuraSite is safe, well tolerated, and effective at reducing inflammation and preventing pain associated with cataract surgery. PMID:27920490

Photographic Assessment of Baseline Fundus Morphology in the Comparison of Age-related Macular Degeneration Treatments Trials

PubMed Central

Grunwald, Juan E.; Daniel, Ebenezer; Ying, Gui-shuang; Pistilli, Maxwell; Maguire, Maureen G.; Alexander, Judith; Whittock-Martin, Revell; Parker, Candace R.; Sepielli, Krista; Blodi, Barbara A.; Martin, Daniel F.

2012-01-01

Objective To describe the methods used for assessment of baseline fundus characteristics from color photography and fluorescein angiography (FA) in the Comparison of the Age-Related Macular Degeneration Treatments Trials (CATT), and the relationship between these characteristics and visual acuity. Design Randomized, masked, multicenter trial. Participants This investigation included 1185 participants of the CATT study. Methods Baseline stereoscopic color fundus photographs and FAs of participants in the CATT study were assessed at a central fundus photograph reading center by masked readers. Replicate assessments of random samples of photographs were performed to assess intra- and inter-grader agreements. The association of the lesion characteristics with baseline visual acuity was assessed using analyses of variance and correlation coefficients. Main Outcome Measures Intra- and inter-grader reproducibility, visual acuity and lesion characteristics. Results Intra- and inter-grader reproducibility showed agreements ranging from 75% to 100% and weighted kappas ranging from 0.48 to 1.0 for qualitative determinations. The intra-class correlation coefficients were 0.96-0.97 for quantitative measurements of choroidal neovascularization (CNV) area and total area of CNV lesion. The mean visual acuity (SE) varied by the type of pathology in the foveal center: 64.5 (0.7) letters for fluid only, 59.0 (0.5) for CNV, and 58.7 (1.3) for hemorrhage (p<0.001). Fibrotic or atrophic scar present in the lesion, but not under the center of the fovea, was also associated with a markedly reduced visual acuity 48.4 (2.2), p<0.0001. Although total area of CNV lesion was weakly correlated with visual acuity when all participants were assessed (Spearman correlation coefficient ρ= −0.16, p<0.001), the correlation was stronger within patients with predominantly classic lesions (ρ=−0.42, p<0.001). Conclusions Our results show that the methodology used for grading CATT fundus images has good reproducibility. As expected, larger total CNV lesion area, and pathologic findings such as hemorrhage, fibrosis and atrophy at baseline are associated with decreased visual acuity. Financial Disclosures The authors have no proprietary or commercial interests in any materials discussed in this article. PMID:22512984

Layout decomposition of self-aligned double patterning for 2D random logic patterning

NASA Astrophysics Data System (ADS)

Ban, Yongchan; Miloslavsky, Alex; Lucas, Kevin; Choi, Soo-Han; Park, Chul-Hong; Pan, David Z.

2011-04-01

Self-aligned double pattering (SADP) has been adapted as a promising solution for sub-30nm technology nodes due to its lower overlay problem and better process tolerance. SADP is in production use for 1D dense patterns with good pitch control such as NAND Flash memory applications, but it is still challenging to apply SADP to 2D random logic patterns. The favored type of SADP for complex logic interconnects is a two mask approach using a core mask and a trim mask. In this paper, we first describe layout decomposition methods of spacer-type double patterning lithography, then report a type of SADP compliant layouts, and finally report SADP applications on Samsung 22nm SRAM layout. For SADP decomposition, we propose several SADP-aware layout coloring algorithms and a method of generating lithography-friendly core mask patterns. Experimental results on 22nm node designs show that our proposed layout decomposition for SADP effectively decomposes any given layouts.

Topical ketorolac tromethamine 0.5% ophthalmic solution in ocular inflammation after cataract surgery.

PubMed

Solomon, K D; Cheetham, J K; DeGryse, R; Brint, S F; Rosenthal, A

2001-02-01

To compare the efficacy and safety of ketorolac 0.5% ophthalmic solution with its vehicle in the treatment of ocular inflammation after cataract surgery and intraocular lens implantation. Multicenter clinical study. One hundred four patients were prospectively randomized, 52 patients in treatment group, 52 patients in control group. Patients received either ketorolac or vehicle four times daily in the operated eye for 14 days starting the day after surgery in a prospective, double-masked, randomized, parallel group study. Only patients with moderate or greater postoperative inflammation the day after surgery were enrolled. The main outcome measures include inflammation (cell, flare, ciliary flush), intraocular pressure and visual acuity. Ketorolac was significantly more effective than vehicle in reducing the manifestations of postoperative ocular inflammation, including: anterior chamber cells (P: = 0.002) and flare (P: = 0.009), conjunctival erythema (P: = 0.010), ciliary flush (P: = 0.022), photophobia (P: = 0.027), and pain (P: = 0.043). Five times as many patients were dropped from the study for lack of efficacy from the vehicle group (22/52) than from the ketorolac group (4/52; P: = 0.001). Ketorolac was found to be equally as safe as vehicle in terms of adverse events, changes in visual acuity, intraocular pressure, and biomicroscopic and ophthalmoscopic variables. Ketorolac tromethamine 0.5% ophthalmic solution was significantly more effective than vehicle in the treatment of moderate or greater ocular inflammation following routine cataract surgery, while being as safe as vehicle.

Pharmacologic Plus Optical Penalization Treatment for Amblyopia: Results of a Randomized Trial

PubMed Central

2008-01-01

Objective To compare weekend atropine augmented by a plano lens for the sound eye with weekend atropine alone for moderate amblyopia in children 3 to <7 years old. Methods In a multi-center clinical trial, 180 children with moderate amblyopia (20/40 to 20/100) were randomized to weekend atropine augmented by a plano lens or weekend atropine alone. Main Outcome Measure Masked assessment of amblyopic eye visual acuity using the Amblyopia Treatment Study HOTV testing protocol at 18 weeks. Results At 18 weeks, amblyopic eye improvement averaged 2.8 lines in the atropine plus plano lens group and 2.4 lines in the atropine alone group (mean difference between groups adjusted for baseline acuity 0.3 lines; 95% confidence interval, −0.2 to 0.8). Amblyopic eye acuity was 20/25 or better in 24 (29%) patients in the atropine-only group and 35 (40%) patients in the atropine plus plano lens group (P=0.03). More patients in the atropine plus plano lens group had reduced sound eye acuity at 18 weeks; however, there were no cases of persistent reverse amblyopia. Conclusions As an initial treatment for moderate amblyopia, the augmentation of weekend atropine with a plano lens does not substantially improve amblyopic eye acuity when compared with atropine alone. Application to Clinical Practice Treatment of children with unilateral amblyopia Trial Registry Name Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old PMID:19139333

The beta-carotene and retinol efficacy trial (CARET) for chemoprevention of lung cancer in high risk populations: smokers and asbestos-exposed workers.

PubMed

Omenn, G S; Goodman, G; Thornquist, M; Grizzle, J; Rosenstock, L; Barnhart, S; Balmes, J; Cherniack, M G; Cullen, M R; Glass, A

1994-04-01

CARET is a multicenter, two-armed, double-masked randomized chemoprevention trial in Seattle, Portland, San Francisco, Baltimore, Connecticut, and Irvine, to test whether oral administration of beta-carotene (30 mg/day) plus retinyl palmitate (25,000 IU/day) can decrease the incidence of lung cancer in high risk populations, namely, heavy smokers and asbestos-exposed workers. The intervention combines the antioxidant action of beta-carotene and the tumor suppressor mechanism of vitamin A. As of April 30, 1993, CARET had randomized 1,845 participants in the 1985-1988 pilot phase plus 13,260 "efficacy" participants since 1989; of these, 4,000 are asbestos-exposed males and 11,105 are smokers and former smokers (44% female). Accrual is complete everywhere except Irvine, which was the last center added (1991), and the safety profile of the regimen to date has been excellent. With 14,420 smokers, 4,010 asbestos-exposed participants, and 114,100 person-years through February 1998, we expect CARET to be capable of detecting a 23% reduction in lung cancer incidence in the two populations combined and 27, 49, 32, and 35% reductions in the smokers, female smokers, male smokers, and asbestos-exposed subgroups, respectively. CARET is highly complementary to the alpha-tocopherol-beta-carotene study in Finland and the Harvard Physicians Health Study (beta-carotene alone) in the National Cancer Institute portfolio of major cancer chemoprevention trials.

Sham radiation in clinical trials assessing radiotherapy for exudative age-related macular degeneration.

PubMed

Marcus, D M; Camp, M W; Sheils, W C; McIntosh, S B; Leibach, D B; Johnson, M H; Samy, C N

1999-01-01

To evaluate the effectiveness of sham radiation treatments in masking patients to their randomization group in the Radiation of Age-Related Macular Degeneration (ROARMD) Study. Patients with choroidal neovascularization complicating age-related macular degeneration were randomized to a treatment (RAD) group that received external beam irradiation (seven treatment sessions) or to a control (SHAM) group that received sham radiation (one sham treatment session). During a telephone survey, 62 of 73 randomized patients responded to the following questions: Do you think you received radiation? Why do you feel that way? Did the vision in your study eye worsen after enrollment? Eighty-one percent of the RAD group and 59% of the SHAM group thought that they had received radiation. In patients who thought that their vision had stabilized or improved, 82% thought that they had received radiation. In patients who thought that their vision was worse, only 39% thought that they had received radiation. In 54% of patients, subjective perception of vision influenced their guess as to whether they received radiation. Subjective patient perception of visual outcome was the most influential variable for masking. Variation between radiation treatment and sham session techniques, such as equipment used and duration of treatments, played a lesser role in the masking of patients. Seven treatment days correlated with a higher number of patients who thought that they had received radiation. Although our procedures do not strictly mask the two groups, one sham radiation session was effective in keeping patients guessing their randomization group.

Statistical analysis plan of the head position in acute ischemic stroke trial pilot (HEADPOST pilot).

PubMed

Olavarría, Verónica V; Arima, Hisatomi; Anderson, Craig S; Brunser, Alejandro; Muñoz-Venturelli, Paula; Billot, Laurent; Lavados, Pablo M

2017-02-01

Background The HEADPOST Pilot is a proof-of-concept, open, prospective, multicenter, international, cluster randomized, phase IIb controlled trial, with masked outcome assessment. The trial will test if lying flat head position initiated in patients within 12 h of onset of acute ischemic stroke involving the anterior circulation increases cerebral blood flow in the middle cerebral arteries, as measured by transcranial Doppler. The study will also assess the safety and feasibility of patients lying flat for ≥24 h. The trial was conducted in centers in three countries, with ability to perform early transcranial Doppler. A feature of this trial was that patients were randomized to a certain position according to the month of admission to hospital. Objective To outline in detail the predetermined statistical analysis plan for HEADPOST Pilot study. Methods All data collected by participating researchers will be reviewed and formally assessed. Information pertaining to the baseline characteristics of patients, their process of care, and the delivery of treatments will be classified, and for each item, appropriate descriptive statistical analyses are planned with comparisons made between randomized groups. For the outcomes, statistical comparisons to be made between groups are planned and described. Results This statistical analysis plan was developed for the analysis of the results of the HEADPOST Pilot study to be transparent, available, verifiable, and predetermined before data lock. Conclusions We have developed a statistical analysis plan for the HEADPOST Pilot study which is to be followed to avoid analysis bias arising from prior knowledge of the study findings. Trial registration The study is registered under HEADPOST-Pilot, ClinicalTrials.gov Identifier NCT01706094.

Depression in Visual Impairment Trial (DEPVIT): A Randomized Clinical Trial of Depression Treatments in People With Low Vision.

PubMed

Nollett, Claire L; Bray, Nathan; Bunce, Catey; Casten, Robin J; Edwards, Rhiannon T; Hegel, Mark T; Janikoun, Sarah; Jumbe, Sandra E; Ryan, Barbara; Shearn, Julia; Smith, Daniel J; Stanford, Miles; Xing, Wen; Margrain, Tom H

2016-08-01

The purpose of this study was to compare two interventions for depression, problem solving treatment (PST) and referral to the patient's physician, with a waiting-list control group in people with sight loss and depressive symptoms. This was an assessor-masked, exploratory, multicenter, randomized clinical trial, with concurrent economic analysis. Of 1008 consecutive attendees at 14 low-vision rehabilitation centers in Britain, 43% (n = 430) screened positive for depressive symptoms on the Geriatric Depression Scale and 85 of these attendees participated in the trial. Eligible participants were randomized in the ratio 1:1:1 to PST, referral to their physician, or a waiting-list control arm. PST is a manualized talking intervention delivered by a trained therapist who teaches people over six to eight sessions to implement a seven-step method for solving their problems. Referral to the physician involved sending a referral letter to the person's physician, encouraging him or her to consider treatment according to the stepped care protocol recommended by the U.K.'s National Institute of Health and Care Excellence. The primary outcome was change in depressive symptoms (6 months after baseline) as determined by the Beck Depression Inventory. At 6 months, Beck Depression Inventory scores reduced by 1.05 (SD 8.85), 2.11 (SD 7.60), and 2.68 (SD 7.93) in the waiting-list control, referral, and PST arms, respectively. The cost per patient of the PST intervention was £1176 in Wales and £1296 in London. Depressive symptoms improved most in the PST group and least in the control group. However, the change was small and the uncertainty of the measurements relatively large.

Reading a standing wave: figure-ground-alternation masking of primes in evaluative priming.

PubMed

Bermeitinger, Christina; Kuhlmann, Michael; Wentura, Dirk

2012-09-01

We propose a new masking technique for masking word stimuli. Drawing on the phenomena of metacontrast and paracontrast, we alternately presented two prime displays of the same word with the background color in one display matching the font color in the other display and vice versa. The sequence of twenty alterations (spanning approx. 267 ms) was sandwich-masked by structure masks. Using this masking technique, we conducted evaluative priming experiments with positive and negative target and prime words. Significant priming effects were found - for primes and targets drawn from the same as well as from different word sets. Priming effects were independent of prime discrimination performance in direct tests and they were still significant after the sample was restricted to those participants who showed random responding in the direct test. Copyright © 2012 Elsevier Inc. All rights reserved.

Effectiveness of a Binocular Video Game vs Placebo Video Game for Improving Visual Functions in Older Children, Teenagers, and Adults With Amblyopia: A Randomized Clinical Trial.

PubMed

Gao, Tina Y; Guo, Cindy X; Babu, Raiju J; Black, Joanna M; Bobier, William R; Chakraborty, Arijit; Dai, Shuan; Hess, Robert F; Jenkins, Michelle; Jiang, Yannan; Kearns, Lisa S; Kowal, Lionel; Lam, Carly S Y; Pang, Peter C K; Parag, Varsha; Pieri, Roberto; Raveendren, Rajkumar Nallour; South, Jayshree; Staffieri, Sandra Elfride; Wadham, Angela; Walker, Natalie; Thompson, Benjamin

2018-02-01

Binocular amblyopia treatment using contrast-rebalanced stimuli showed promise in laboratory studies and requires clinical trial investigation in a home-based setting. To compare the effectiveness of a binocular video game with a placebo video game for improving visual functions in older children and adults. The Binocular Treatment of Amblyopia Using Videogames clinical trial was a multicenter, double-masked, randomized clinical trial. Between March 2014 and June 2016, 115 participants 7 years and older with unilateral amblyopia (amblyopic eye visual acuity, 0.30-1.00 logMAR; Snellen equivalent, 20/40-20/200) due to anisometropia, strabismus, or both were recruited. Eligible participants were allocated with equal chance to receive either the active or the placebo video game, with minimization stratified by age group (child, age 7 to 12 years; teenager, age 13 to 17 years; and adult, 18 years and older). Falling-blocks video games played at home on an iPod Touch for 1 hour per day for 6 weeks. The active video game had game elements split between eyes with a dichoptic contrast offset (mean [SD] initial fellow eye contrast, 0.23 [0.14]). The placebo video game presented identical images to both eyes. Change in amblyopic eye visual acuity at 6 weeks. Secondary outcomes included compliance, stereoacuity, and interocular suppression. Participants and clinicians who measured outcomes were masked to treatment allocation. Of the 115 included participants, 65 (56.5%) were male and 83 (72.2%) were white, and the mean (SD) age at randomization was 21.5 (13.6) years. There were 89 participants (77.4%) who had prior occlusion. The mean (SD) amblyopic eye visual acuity improved 0.06 (0.12) logMAR from baseline in the active group (n = 56) and 0.07 (0.10) logMAR in the placebo group (n = 59). The mean treatment difference between groups, adjusted for baseline visual acuity and age group, was -0.02 logMAR (95% CI, -0.06 to 0.02; P = .25). Compliance with more than 25% of prescribed game play was achieved by 36 participants (64%) in the active group and by 49 (83%) in the placebo group. At 6 weeks, 36 participants (64%) in the active group achieved fellow eye contrast greater than 0.9 in the binocular video game. No group differences were observed for any secondary outcomes. Adverse effects included 3 reports of transient asthenopia. The specific home-based binocular falling-blocks video game used in this clinical trial did not improve visual outcomes more than the placebo video game despite increases in fellow eye contrast during game play. More engaging video games with considerations for compliance may improve effectiveness. anzctr.org.au Identifier: ACTRN12613001004752.

Temporal phase mask encrypted optical steganography carried by amplified spontaneous emission noise.

PubMed

Wu, Ben; Wang, Zhenxing; Shastri, Bhavin J; Chang, Matthew P; Frost, Nicholas A; Prucnal, Paul R

2014-01-13

A temporal phase mask encryption method is proposed and experimentally demonstrated to improve the security of the stealth channel in an optical steganography system. The stealth channel is protected in two levels. In the first level, the data is carried by amplified spontaneous emission (ASE) noise, which cannot be detected in either the time domain or spectral domain. In the second level, even if the eavesdropper suspects the existence of the stealth channel, each data bit is covered by a fast changing phase mask. The phase mask code is always combined with the wide band noise from ASE. Without knowing the right phase mask code to recover the stealth data, the eavesdropper can only receive the noise like signal with randomized phase.

[Intensive care unit profesionals's knowledge about non invasive ventilation comparative analysis].

PubMed

Raurell-Torredà, M; Argilaga-Molero, E; Colomer-Plana, M; Ruiz-García, T; Galvany-Ferrer, A; González-Pujol, A

2015-01-01

The literature highlights the lack of noninvasive ventilation (NIV) protocols and the variability of the knowledge of NIV between intensive care units (ICU) and hospitals, so we want to compare NIV nurses's Knowledge from 4 multipurpose ICU and one surgical ICU. Multicenter, crosscutting, descriptive study in three university hospitals. The survey instrument was validated in a pilot test, and the calculated Kappa index was 0.9. Returning a completed survey is an indication of informed consent. Analysis by Chi square test. 117 responded (65%) nurses, 11±9.7 years of experience in ICU and 9.2±7.2 in use of NIV. One of the multipurpose ICU, was initiated NIV an average of 6 years later than the others (95% CI [3.3 to 8.6], P<.001). Only 23.1% of nurses would place a non-vented mask (with no exhalation port) by conventional ventilator, the rest any kind of face mask. 12.7% believed that the mask must be adjusted to the "2-finger" fit while 29% would seal the mask to the patient's face and cover the mask opening where air escapes to facilitate patient/ventilator synchronization. In the surgical ICU agitation identifies mostly as a complication of NIV compared with multipurpose UCIs (31.6% vs 1.8%, P<.001). 56.4% of nurses do not consider respiratory physiotherapy as nursing care, with no difference between units. Knowledge about types of interface is very dependent on the material of the unit. More training for complications of NIV as agitation and handling secretions it is necessary. Copyright © 2014 Elsevier España, S.L.U. y SEEIUC. All rights reserved.

A Multicenter, Rater-Blinded, Randomized Controlled Study of Auditory Processing-Focused Cognitive Remediation Combined With Open-Label Lurasidone in Patients With Schizophrenia and Schizoaffective Disorder.

PubMed

Kantrowitz, Joshua T; Sharif, Zafar; Medalia, Alice; Keefe, Richard S E; Harvey, Philip; Bruder, Gerard; Barch, Deanna M; Choo, Tse; Lee, Seonjoo; Lieberman, Jeffrey A

2016-06-01

Small-scale studies of auditory processing cognitive remediation programs have demonstrated efficacy in schizophrenia. We describe a multicenter, rater-blinded, randomized, controlled study of auditory-focused cognitive remediation, conducted from June 24, 2010, to June 14, 2013, and approved by the local institutional review board at all sites. Prior to randomization, participants with schizophrenia (DSM-IV-TR) were stabilized on a standardized antipsychotic regimen (lurasidone [40-160 mg/d]), followed by randomization to adjunctive cognitive remediation: auditory focused (Brain Fitness) versus control (nonspecific video games), administered 1-2 times weekly for 30 sessions. Coprimary outcome measures included MATRICS Consensus Cognitive Battery (MCCB) and the University of California, San Diego, Performance-Based Skills Assessment-Brief scale. 120 participants were randomized and completed at least 1 auditory-focused cognitive remediation (n = 56) or video game control session (n = 64). 74 participants completed ≥ 25 sessions and postrandomization assessments. At study completion, the change from prestabilization was statistically significant for MCCB composite score (d = 0.42, P < .0001) across groups. Participants randomized to auditory-focused cognitive remediation had a trend-level higher mean MCCB composite score compared to participants randomized to control cognitive remediation (P = .08). After controlling for scores at the time of randomization, there were no significant between-treatment group differences at study completion. Auditory processing cognitive remediation combined with lurasidone did not lead to differential improvement over nonspecific video games. Across-group improvement from prestabilization baseline to study completion was observed, but since all participants were receiving lurasidone open label, it is difficult to interpret the source of these effects. Future studies comparing both pharmacologic and behavioral cognitive enhancers should consider a 2 × 2 design, using a control for both the medication and the cognitive remediation. ClinicalTrials.gov identifier: NCT01173874. © Copyright 2016 Physicians Postgraduate Press, Inc.

Tear cytokine profile as a noninvasive biomarker of inflammation for ocular surface diseases: standard operating procedures.

PubMed

Wei, Yi; Gadaria-Rathod, Neha; Epstein, Seth; Asbell, Penny

2013-12-23

To provide standard operating procedures (SOPs) for measuring tear inflammatory cytokine concentrations and to validate the resulting profile as a minimally invasive objective metric and biomarker of ocular surface inflammation for use in multicenter clinical trials on dry eye disease (DED). Standard operating procedures were established and then validated with cytokine standards, quality controls, and masked tear samples collected from local and distant clinical sites. The concentrations of the inflammatory cytokines in tears were quantified using a high-sensitivity human cytokine multiplex kit. A panel of inflammatory cytokines was initially investigated, from which four key inflammatory cytokines (IL-1β, IL-6, INF-γ, and TNF-α) were chosen. Results with cytokine standards statistically satisfied the manufacturer's quality control criteria. Results with pooled tear samples were highly reproducible and reliable with tear volumes ranging from 4 to 10 μL. Incorporation of the SOPs into clinical trials was subsequently validated. Tear samples were collected at a distant clinical site, stored, and shipped to our Biomarker Laboratory, where a masked analysis of the four tear cytokines was successfully performed. Tear samples were also collected from a feasibility study on DED. Inflammatory cytokine concentrations were decreased in tears of subjects who received anti-inflammatory treatment. Standard operating procedures for human tear cytokine assessment suitable for multicenter clinical trials were established. Tear cytokine profiling using these SOPs may provide objective metrics useful for diagnosing, classifying, and analyzing treatment efficacy in inflammatory conditions of the ocular surface, which may further elucidate the mechanisms involved in the pathogenesis of ocular surface disease.

Use of adjunctive mitomycin C in external dacryocystorhinostomy surgery compared with surgery alone in patients with nasolacrimal duct obstruction: A prospective, double-masked, randomized, controlled trial.

PubMed

Ari, Seyhmus; Gun, Ramazan; Surmeli, Serdar; Atay, Ahmet Engin; Caca, Ihsan

2009-08-01

The most common cause for the failure of external dacryocystorhinostomy (DCR) surgery is the formation of granulation tissue at the osteotomy site or common canaliculus. The aims of this study were to assess the efficacy of intraoperative adjunctive mitomycin C (MMC) treatment in external DCR surgery and to compare this procedure with the standard DCR procedure alone in the long term (1 year). In this prospective, double-masked, randomized, controlled trial, patients with primary acquired nasolacrimal duct obstruction were randomized (using a random number table) into 2 groups based on surgical procedure. In the MMC group, intraoperative adjunctive MMC 0.2 mg/mL was applied to the osteotomy site for 30 minutes. The control group underwent standard DCR procedure only. The results of the DCR surgeries were assessed using objective findings (eg, cessation of excessive tearing via nasolacrimal duct irrigation and the improvement in height of tear meniscus) and subjective symptoms (asking patients to describe the degree of tearing improvement). Both the patients and the researchers who were assessing the study outcomes were masked to treatment group. One hundred eyes of 100 Turkish patients were assessed and equally randomized to the MMC (27 women, 23 men; mean [SD] age, 47.0 [7.6] years) and control (26 women, 24 men; mean age, 46.6 [8.8] years) groups. The follow-up period was not significantly different between the MMC and the control groups (13.1 [1.1] vs 13.2 [1.4] months). Significantly more eyes in the MMC group than the control group remained symptom-free throughout the 1-year follow-up period (45/50 [90%] vs 33/50 [66%]; P=0.005). Significantly more patients in the control group than the MMC group had an improvement in symptoms at the 1-year follow-up (8/50 [16%] vs 2/50 [4%] eyes; P=0.005). Based on the patency of the drainage system, the success rate was significantly greater in the MMC group than the control group (48/50 [96%] vs 42/50 [84%]; P=0.005). Based on nasolacrimal duct irrigation, significantly fewer patients in the MMC group than the control group had an enclosed naso-lacrimal duct (2/50 [4%] vs 8/50 [16%]). No adverse effects (eg, abnormal nasal bleeding, mucosal necrosis, infection) or any other surgical adverse events were observed. In the management of these patients with primary acquired nasolacrimal duct obstruction, adjunctive intraoperative MMC application with standard DCR surgery had a significantly higher success rate than did standard DCR surgery alone. Further large, double-masked, randomized studies are needed to confirm these findings.

Use of adjunctive mitomycin C in external dacryocystorhinostomy surgery compared with surgery alone in patients with nasolacrimal duct obstruction: A prospective, double-masked, randomized, controlled trial

PubMed Central

Ari, Şeyhmus; Gun, Ramazan; Surmeli, Serdar; Atay, Ahmet Engin; Çaca, Îhsan

2009-01-01

Background: The most common cause for the failure of external dacryocystorhinostomy (DCR) surgery is the formation of granulation tissue at the osteotomy site or common canaliculus. Objectives: The aims of this study were to assess the efficacy of intraoperative adjunctive mitomycin C (MMC) treatment in external DCR surgery and to compare this procedure with the standard DCR procedure alone in the long term (1 year). Methods: In this prospective, double-masked, randomized, controlled trial, patients with primary acquired nasolacrimal duct obstruction were randomized (using a random number table) into 2 groups based on surgical procedure. In the MMC group, intraoperative adjunctive MMC 0.2 mg/mL was applied to the osteotomy site for 30 minutes. The control group underwent standard DCR procedure only. The results of the DCR surgeries were assessed using objective findings (eg, cessation of excessive tearing via nasolacrimal duct irrigation and the improvement in height of tear meniscus) and subjective symptoms (asking patients to describe the degree of tearing improvement). Both the patients and the researchers who were assessing the study outcomes were masked to treatment group. Results: One hundred eyes of 100 Turkish patients were assessed and equally randomized to the MMC (27 women, 23 men; mean [SD] age, 47.0 [7.6] years) and control (26 women, 24 men; mean age, 46.6 [8.8] years) groups. The follow-up period was not significantly different between the MMC and the control groups (13.1 [1.1] vs 13.2 [1.4] months). Significantly more eyes in the MMC group than the control group remained symptom-free throughout the 1-year follow-up period (45/50 [90%] vs 33/50 [66%]; P=0.005). Significantly more patients in the control group than the MMC group had an improvement in symptoms at the 1-year follow-up (8/50 [16%] vs 2/50 [4%] eyes; P=0.005). Based on the patency of the drainage system, the success rate was significantly greater in the MMC group than the control group (48/50 [96%] vs 42/50 [84%]; P=0.005). Based on nasolacrimal duct irrigation, significantly fewer patients in the MMC group than the control group had an enclosed naso-lacrimal duct (2/50 [4%] vs 8/50 [16%]). No adverse effects (eg, abnormal nasal bleeding, mucosal necrosis, infection) or any other surgical adverse events were observed. Conclusions: In the management of these patients with primary acquired nasolacrimal duct obstruction, adjunctive intraoperative MMC application with standard DCR surgery had a significantly higher success rate than did standard DCR surgery alone. Further large, double-masked, randomized studies are needed to confirm these findings. PMID:24683236

[Reduction of pressure sores during prone positioning of ventilated intensive care patients by the prone-head support system: a pilot study].

PubMed

Prebio, Michael; Katz-Papatheophilou, Elfriede; Heindl, Werner; Gelbmann, Herbert; Burghuber, Otto C

2005-02-01

Prone positioning in patients with adult respiratory distress syndrome is a well-known method to improve oxygenation. The aim of our study was to evaluate a new device for prone positioning, the prone-head support system (PHS system), with regard to reduction of cutaneous pressure sores. In a pilot study we randomized 8 patients with ARDS in two groups: 180 degrees standard prone positioning (group without mask) and prone positioning with the PHS system (group with mask). The PHS system consists of a facemask support, which is connected to an adapted air suspension bed. The patients of both groups were intermittently proned for several days. We evaluated the pressure sores on head and neck before turning the patients prone for the first time and after each period of prone positioning. We documented the quantity, the size, the type and the localization of the pressure sores. There was no significant difference in the mean duration of prone positioning (27.1+/-14.7 hours in the group with mask versus 24.5+/-18.7 h in the group without mask). In the group with mask there were 1.5+/-0.8 new pressure sores by each proning, whereas in the group without mask there were 2.37+/-1.6 new pressure sores, which was lower, but not significantly. The overall area of pressure sores (798 mm2 versus 3184 mm2, p=0.004), the area of pressure sores per patient (199.5+/-104.7 mm2 versus 796+/-478 mm2, p=0.03) and the increase of the area of pressure sores per proning (79.8+/-52.0 mm2 versus 398.0+/-214.3 mm2, p=0.004) were significantly lower in the group with mask in comparison to the group without mask. The lips were the most effected localization in both groups. The pressure sores in the group with mask were less severe and showed a homogenous distribution in comparison to the group without mask. Blisters dominated in the group with mask in comparison to erosions, necrosis and ulcers in the group without mask. The PHS system with its face mask is able to reduce the extent and the severity of pressure sores in patients ventilated in prone position. Controlled randomized studies with large study populations seem justified.

Factors Influencing Medical Student Attrition and Their Implications in a Large Multi-Center Randomized Education Trial

ERIC Educational Resources Information Center

Kalet, A.; Ellaway, R. H.; Song, H. S.; Nick, M.; Sarpel, U.; Hopkins, M. A.; Hill, J.; Plass, J. L.; Pusic, M. V.

2013-01-01

Participant attrition may be a significant threat to the generalizability of the results of educational research studies if participants who do not persist in a study differ from those who do in ways that can affect the experimental outcomes. A multi-center trial of the efficacy of different computer-based instructional strategies gave us the…

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

McMillan, Kyle; Marleau, Peter; Brubaker, Erik

In coded aperture imaging, one of the most important factors determining the quality of reconstructed images is the choice of mask/aperture pattern. In many applications, uniformly redundant arrays (URAs) are widely accepted as the optimal mask pattern. Under ideal conditions, thin and highly opaque masks, URA patterns are mathematically constructed to provide artifact-free reconstruction however, the number of URAs for a chosen number of mask elements is limited and when highly penetrating particles such as fast neutrons and high-energy gamma-rays are being imaged, the optimum is seldom achieved. In this case more robust mask patterns that provide better reconstructed imagemore » quality may exist. Through the use of heuristic optimization methods and maximum likelihood expectation maximization (MLEM) image reconstruction, we show that for both point and extended neutron sources a random mask pattern can be optimized to provide better image quality than that of a URA.« less

Fabrication of coronagraph masks and laboratory scale star-shade masks: characteristics, defects, and performance

NASA Astrophysics Data System (ADS)

Balasubramanian, Kunjithapatham; Riggs, A. J. Eldorado; Cady, Eric; White, Victor; Yee, Karl; Wilson, Daniel; Echternach, Pierre; Muller, Richard; Mejia Prada, Camilo; Seo, Byoung-Joon; Shi, Fang; Ryan, Daniel; Fregoso, Santos; Metzman, Jacob; Wilson, Robert Casey

2017-09-01

NASA WFIRST mission has planned to include a coronagraph instrument to find and characterize exoplanets. Masks are needed to suppress the host star light to better than 10-8 - 10-9 level contrast over a broad bandwidth to enable the coronagraph mission objectives. Such masks for high contrast coronagraphic imaging require various fabrication technologies to meet a wide range of specifications, including precise shapes, micron scale island features, ultra-low reflectivity regions, uniformity, wave front quality, etc. We present the technologies employed at JPL to produce these pupil plane and image plane coronagraph masks, and lab-scale external occulter masks, highlighting accomplishments from the high contrast imaging testbed (HCIT) at JPL and from the high contrast imaging lab (HCIL) at Princeton University. Inherent systematic and random errors in fabrication and their impact on coronagraph performance are discussed with model predictions and measurements.

A multi-center randomized controlled trial to compare a self-ligating bracket with a conventional bracket in a UK population: Part 1: Treatment efficiency.

PubMed

O'Dywer, Lian; Littlewood, Simon J; Rahman, Shahla; Spencer, R James; Barber, Sophy K; Russell, Joanne S

2016-01-01

To use a two-arm parallel trial to compare treatment efficiency between a self-ligating and a conventional preadjusted edgewise appliance system. A prospective multi-center randomized controlled clinical trial was conducted in three hospital orthodontic departments. Subjects were randomly allocated to receive treatment with either a self-ligating (3M SmartClip) or conventional (3M Victory) preadjusted edgewise appliance bracket system using a computer-generated random sequence concealed in opaque envelopes, with stratification for operator and center. Two operators followed a standardized protocol regarding bracket bonding procedure and archwire sequence. Efficiency of each ligation system was assessed by comparing the duration of treatment (months), total number of appointments (scheduled and emergency visits), and number of bracket bond failures. One hundred thirty-eight subjects (mean age 14 years 11 months) were enrolled in the study, of which 135 subjects (97.8%) completed treatment. The mean treatment time and number of visits were 25.12 months and 19.97 visits in the SmartClip group and 25.80 months and 20.37 visits in the Victory group. The overall bond failure rate was 6.6% for the SmartClip and 7.2% for Victory, with a similar debond distribution between the two appliances. No significant differences were found between the bracket systems in any of the outcome measures. No serious harm was observed from either bracket system. There was no clinically significant difference in treatment efficiency between treatment with a self-ligating bracket system and a conventional ligation system.

The Relationship between MOC Reflex and Masked Threshold

PubMed Central

Garinis, Angela; Werner, Lynne; Abdala, Carolina

2011-01-01

Otoacoustic emission (OAE) amplitude can be reduced by acoustic stimulation. This effect is produced by the medial olivocochlear (MOC) reflex. Past studies have shown that the MOC reflex is related to listening in noise and attention. In the present study, the relationship between strength of the contralateral MOC reflex and masked threshold was investigated in 19 adults. Detection thresholds were determined for a 1000-Hz, 300-ms tone presented simultaneously with one repetition of a 300-ms masker in an ongoing train of 300-ms masker bursts at 600-ms intervals. Three masking conditions were tested: 1) broadband noise 2) a fixed-frequency 4-tone complex masker and 3) a random-frequency 4-tone complex masker. Broadband noise was expected to produce energetic masking and the tonal maskers were expected to produce informational masking in some listeners. DPOAEs were recorded at fine frequency interval from 500 to 4000 Hz, with and without contralateral acoustic stimulation. MOC reflex strength was estimated as a reduction in baseline level and a shift in frequency of DPOAE fine-structure maxima near 1000-Hz. MOC reflex and psychophysical testing were completed in separate sessions. Individuals with poorer thresholds in broadband noise and in random-frequency maskers were found to have stronger MOC reflexes. PMID:21878379

A new suction mask to reduce leak during neonatal resuscitation: a manikin study.

PubMed

Lorenz, Laila; Maxfield, Dominic A; Dawson, Jennifer A; Kamlin, C Omar F; McGrory, Lorraine; Thio, Marta; Donath, Susan M; Davis, Peter G

2016-09-01

Leak around the face mask is a common problem during neonatal resuscitation. A newly designed face mask using a suction system to enhance contact between the mask and the infant's face might reduce leak and improve neonatal resuscitation. The aim of the study is to determine whether leak is reduced using the suction mask (Resusi-sure mask) compared with a conventional mask (Laerdal Silicone mask) in a manikin model. Sixty participants from different professional categories (neonatal consultants, fellows, registrars, nurses, midwives and students) used each face mask in a random order to deliver 2 min of positive pressure ventilation to a manikin. Delivered airway pressures were measured using a pressure line. Inspiratory and expiratory flows were measured using a flow sensor, and expiratory tidal volumes and mask leaks were derived from these values. A median (IQR) leak of 12.1 (0.6-39.0)% was found with the conventional mask compared with 0.7 (0.2-4.6)% using the suction mask (p=0.002). 50% of the participants preferred to use the suction mask and 38% preferred to use the conventional mask. There was no correlation between leak and operator experience. A new neonatal face mask based on the suction system reduced leak in a manikin model. Clinical studies to test the safety and effectiveness of this mask are needed. 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/

Defect reduction for semiconductor memory applications using jet and flash imprint lithography

NASA Astrophysics Data System (ADS)

Ye, Zhengmao; Luo, Kang; Lu, Xiaoming; Fletcher, Brian; Liu, Weijun; Xu, Frank; LaBrake, Dwayne; Resnick, Douglas J.; Sreenivasan, S. V.

2012-07-01

Acceptance of imprint lithography for manufacturing will require demonstration that it can attain defect levels commensurate with the defect specifications of high-end memory devices. Defects occurring during imprinting can generally be broken into two categories; random defects and repeating defects. Examples of random defects include fluid phase imprint defects, such as bubbles, and solid phase imprint defects, such as line collapse. Examples of repeater defects include mask fabrication defects and particle induced defects. Previous studies indicated that soft particles cause nonrepeating defects. Hard particles, on the other hand, can cause either permanent resist plugging or mask damage. In a previous study, two specific defect types were examined; random nonfill defects occurring during the resist filling process and repeater defects caused by interactions with particles on the substrate. We attempted to identify the different types of imprint defect types using a mask with line/space patterns at dimensions as small as 26 nm. An Imprio 500 twenty-wafer per hour development tool was used to study the various defect types. The imprint defect density was reduced nearly four orders of magnitude, down to ˜4/cm2 in a period of two years following the availability of low defect imprint masks at 26-nm half-pitch. This reduction was achieved by identifying the root cause of various defects and then taking the appropriate corrective action.

Tuning the cognitive environment: Sound masking with 'natural' sounds in open-plan offices

NASA Astrophysics Data System (ADS)

DeLoach, Alana

With the gain in popularity of open-plan office design and the engineering efforts to achieve acoustical comfort for building occupants, a majority of workers still report dissatisfaction in their workplace environment. Office acoustics influence organizational effectiveness, efficiency, and satisfaction through meeting appropriate requirements for speech privacy and ambient sound levels. Implementing a sound masking system is one tried-and-true method of achieving privacy goals. Although each sound masking system is tuned for its specific environment, the signal -- random steady state electronic noise, has remained the same for decades. This research work explores how `natural' sounds may be used as an alternative to this standard masking signal employed so ubiquitously in sound masking systems in the contemporary office environment. As an unobtrusive background sound, possessing the appropriate spectral characteristics, this proposed use of `natural' sounds for masking challenges the convention that masking sounds should be as meaningless as possible. Through the pilot study presented in this work, we hypothesize that `natural' sounds as sound maskers will be as effective at masking distracting background noise as the conventional masking sound, will enhance cognitive functioning, and increase participant (worker) satisfaction.

Inter- and intrafraction patient positioning uncertainties for intracranial radiotherapy: a study of four frameless, thermoplastic mask-based immobilization strategies using daily cone-beam CT.

PubMed

Tryggestad, Erik; Christian, Matthew; Ford, Eric; Kut, Carmen; Le, Yi; Sanguineti, Giuseppe; Song, Danny Y; Kleinberg, Lawrence

2011-05-01

To determine whether frameless thermoplastic mask-based immobilization is adequate for image-guided cranial radiosurgery. Cone-beam CT localization data from patients with intracranial tumors were studied using daily pre- and posttreatment scans. The systems studied were (1) Type-S IMRT (head only) mask (Civco) with head cushion; (2) Uni-Frame mask (Civco) with head cushion, coupled with a BlueBag body immobilizer (Medical Intelligence); (3) Type-S head and shoulder mask with head and shoulder cushion (Civco); (4) same as previous, coupled with a mouthpiece. The comparative metrics were translational shift magnitude and average rotation angle; systematic inter-, random inter-, and random intrafraction positioning error was computed. For strategies 1-4, respectively, the analysis for interfraction variability included data from 20, 9, 81, and 11 patients, whereas that for intrafraction variability included a subset of 7, 9, 16, and 8 patients. The results were compared for statistical significance using an analysis of variance test. Immobilization system 4 provided the best overall accuracy and stability. The mean interfraction translational shifts (± SD) were 2.3 (± 1.4), 2.2 (± 1.1), 2.7 (± 1.5), and 2.1 (± 1.0) mm whereas intrafraction motion was 1.1 (± 1.2), 1.1 (± 1.1), 0.7 (± 0.9), and 0.7 (± 0.8) mm for devices 1-4, respectively. No significant correlation between intrafraction motion and treatment time was evident, although intrafraction motion was not purely random. We find that all frameless thermoplastic mask systems studied are viable solutions for image-guided intracranial radiosurgery. With daily pretreatment corrections, symmetric PTV margins of 1 mm would likely be adequate if ideal radiation planning and targeting systems were available. Copyright © 2011 Elsevier Inc. All rights reserved.

Sparsely sampling the sky: Regular vs. random sampling

NASA Astrophysics Data System (ADS)

Paykari, P.; Pires, S.; Starck, J.-L.; Jaffe, A. H.

2015-09-01

Aims: The next generation of galaxy surveys, aiming to observe millions of galaxies, are expensive both in time and money. This raises questions regarding the optimal investment of this time and money for future surveys. In a previous work, we have shown that a sparse sampling strategy could be a powerful substitute for the - usually favoured - contiguous observation of the sky. In our previous paper, regular sparse sampling was investigated, where the sparse observed patches were regularly distributed on the sky. The regularity of the mask introduces a periodic pattern in the window function, which induces periodic correlations at specific scales. Methods: In this paper, we use a Bayesian experimental design to investigate a "random" sparse sampling approach, where the observed patches are randomly distributed over the total sparsely sampled area. Results: We find that in this setting, the induced correlation is evenly distributed amongst all scales as there is no preferred scale in the window function. Conclusions: This is desirable when we are interested in any specific scale in the galaxy power spectrum, such as the matter-radiation equality scale. As the figure of merit shows, however, there is no preference between regular and random sampling to constrain the overall galaxy power spectrum and the cosmological parameters.

Preventing central venous catheter-associated primary bloodstream infections: characteristics of practices among hospitals participating in the Evaluation of Processes and Indicators in Infection Control (EPIC) study.

PubMed

Braun, Barbara I; Kritchevsky, Stephen B; Wong, Edward S; Solomon, Steve L; Steele, Lynn; Richards, Cheryl L; Simmons, Bryan P

2003-12-01

To describe the conceptual framework and methodology of the Evaluation of Processes and Indicators in Infection Control (EPIC) study and present results of CVC insertion characteristics and organizational practices for preventing BSIs. The goal of the EPIC study was to evaluate relationships among processes of care, organizational characteristics, and the outcome of BSI. This was a multicenter prospective observational study of variation in hospital practices related to preventing CVC-associated BSIs. Process of care information (eg, barrier use during insertions and experience of the inserting practitioner) was collected for a random sample of approximately 5 CVC insertions per month per hospital during November 1998 to December 1999. Organization demographic and practice information (eg, surveillance activities and staff and ICU nurse staffing levels) was also collected. Medical, surgical, or medical-surgical ICUs from 55 hospitals (41 U.S. and 14 international sites). Process information was obtained for 3,320 CVC insertions with an average of 58.2 (+/- 16.1) insertions per hospital. Fifty-four hospitals provided policy and practice information. Staff spent an average of 13 hours per week in study ICU surveillance. Most patients received nontunneled, multiple lumen CVCs, of which fewer than 25% were coated with antimicrobial material. Regarding barriers, most clinicians wore masks (81.5%) and gowns (76.8%); 58.1% used large drapes. Few hospitals (18.1%) used an intravenous team to manage ICU CVCs. Substantial variation exists in CVC insertion practice and BSI prevention activities. Understanding which practices have the greatest impact on BSI rates can help hospitals better target improvement interventions.

Assessment of the methodological and ethical quality of clinical trials published in family medicine journals

PubMed

Castaño-García, Alberto; Guillén-Grima, Francisco; León-Sanz, Pilar

2018-01-01

To evaluate some methodological and ethical quality variables of clinical trials (CTs) published in 10 family medicine journals. Quality descriptive study of 10 family medicine journals including CTs in humans published since 2010 to 2013. We obtained 141 CT and 2447 were excluded. CTs parallels controlled in 92.9% (95% confidence interval [95% CI]: 92.0-93.9). Masked randomization in 72.3% (95% CI: 71.7-73.1), decentralized in 51.8% (95% CI: 51.4-52.4) and using as control an active treatment in 82.2% (95% CI: 81.5-83.1). Wrote informed consent in 48.9% (95% CI: 48.5-49.5) and it was not withdrawn in 56.0% of cases (95% CI: 55.5-56.7). Approval by clinical research ethics committee (CREC) in 134, and there was no conflict of interest in 117 CTs. Average κ was 0.96 (95% CI: 0.93-0.99). We observe an increase in some quality variables like masked randomization (19.6%) and approval by CREC (75%) post CONSORT, in CTs published in 10 family medicine journals (2010-2013). Copyright: © 2018 SecretarÍa de Salud

Psychotherapy Augmentation through Preconscious Priming

PubMed Central

Borgeat, François; O’Connor, Kieron; Amado, Danielle; St-Pierre-Delorme, Marie-Ève

2013-01-01

Objective: To test the hypothesis that repeated preconscious (masked) priming of personalized positive cognitions could augment cognitive change and facilitate achievement of patients’ goals following a therapy. Methods: Twenty social phobic patients (13 women) completed a 36-weeks study beginning by 12 weeks of group behavioral therapy. After the therapy, they received 6 weeks of preconscious priming and 6 weeks of a control procedure in a randomized cross-over design. The Priming condition involved listening twice daily with a passive attitude to a recording of individualized formulations of appropriate cognitions and attitudes masked by music. The Control condition involved listening to an indistinguishable recording where the formulations had been replaced by random numbers. Changes in social cognitions were measured by the Social Interaction Self Statements Test (SISST). Results: Patients improved following therapy. The Priming procedure was associated with increased positive cognitions and decreased negative cognitions on the SISST while the Control procedure was not. The Priming procedure induced more cognitive change when applied immediately after the group therapy. Conclusion: An effect of priming was observed on social phobia related cognitions in the expected direction. This self administered addition to a therapy could be seen as an augmentation strategy. PMID:23508724

Informational masking and musical training

NASA Astrophysics Data System (ADS)

Oxenham, Andrew J.; Fligor, Brian J.; Mason, Christine R.; Kidd, Gerald

2003-09-01

The relationship between musical training and informational masking was studied for 24 young adult listeners with normal hearing. The listeners were divided into two groups based on musical training. In one group, the listeners had little or no musical training; the other group was comprised of highly trained, currently active musicians. The hypothesis was that musicians may be less susceptible to informational masking, which is thought to reflect central, rather than peripheral, limitations on the processing of sound. Masked thresholds were measured in two conditions, similar to those used by Kidd et al. [J. Acoust. Soc. Am. 95, 3475-3480 (1994)]. In both conditions the signal was comprised of a series of repeated tone bursts at 1 kHz. The masker was comprised of a series of multitone bursts, gated with the signal. In one condition the frequencies of the masker were selected randomly for each burst; in the other condition the masker frequencies were selected randomly for the first burst of each interval and then remained constant throughout the interval. The difference in thresholds between the two conditions was taken as a measure of informational masking. Frequency selectivity, using the notched-noise method, was also estimated in the two groups. The results showed no difference in frequency selectivity between the two groups, but showed a large and significant difference in the amount of informational masking between musically trained and untrained listeners. This informational masking task, which requires no knowledge specific to musical training (such as note or interval names) and is generally not susceptible to systematic short- or medium-term training effects, may provide a basis for further studies of analytic listening abilities in different populations.

Oronasal Masks Require a Higher Pressure than Nasal and Nasal Pillow Masks for the Treatment of Obstructive Sleep Apnea.

PubMed

Deshpande, Sheetal; Joosten, Simon; Turton, Anthony; Edwards, Bradley A; Landry, Shane; Mansfield, Darren R; Hamilton, Garun S

2016-09-15

Oronasal masks are frequently used for continuous positive airway pressure (CPAP) treatment in patients with obstructive sleep apnea (OSA). The aim of this study was to (1) determine if CPAP requirements are higher for oronasal masks compared to nasal mask interfaces and (2) assess whether polysomnography and patient characteristics differed among mask preference groups. Retrospective analysis of all CPAP implementation polysomnograms between July 2013 and June 2014. Prescribed CPAP level, polysomnography results and patient data were compared according to mask type (n = 358). Oronasal masks were used in 46%, nasal masks in 35% and nasal pillow masks in 19%. There was no difference according to mask type for baseline apnea-hypopnea index (AHI), body mass index (BMI), waist or neck circumference. CPAP level was higher for oronasal masks, 12 (10-15.5) cm H2O compared to nasal pillow masks, 11 (8-12.5) cm H2O and nasal masks, 10 (8-12) cm H2O, p < 0.0001 (Median [interquartile range]). Oronasal mask type, AHI, age, and BMI were independent predictors of a higher CPAP pressure (p < 0.0005, adjusted R(2) = 0.26.). For patients with CPAP ≥ 15 cm H2O, there was an odds ratio of 4.5 (95% CI 2.5-8.0) for having an oronasal compared to a nasal or nasal pillow mask. Residual median AHI was higher for oronasal masks (11.3 events/h) than for nasal masks (6.4 events/h) and nasal pillows (6.7 events/h), p < 0.001. Compared to nasal mask types, oronasal masks are associated with higher CPAP pressures (particularly pressures ≥ 15 cm H2O) and a higher residual AHI. Further evaluation with a randomized control trial is required to definitively establish the effect of mask type on pressure requirements. A commentary on this article appears in this issue on page 1209. © 2016 American Academy of Sleep Medicine.

Effect of Masked Regions on Weak-lensing Statistics

NASA Astrophysics Data System (ADS)

Shirasaki, Masato; Yoshida, Naoki; Hamana, Takashi

2013-09-01

Sky masking is unavoidable in wide-field weak-lensing observations. We study how masks affect the measurement of statistics of matter distribution probed by weak gravitational lensing. We first use 1000 cosmological ray-tracing simulations to examine in detail the impact of masked regions on the weak-lensing Minkowski Functionals (MFs). We consider actual sky masks used for a Subaru Suprime-Cam imaging survey. The masks increase the variance of the convergence field and the expected values of the MFs are biased. The bias then compromises the non-Gaussian signals induced by the gravitational growth of structure. We then explore how masks affect cosmological parameter estimation. We calculate the cumulative signal-to-noise ratio (S/N) for masked maps to study the information content of lensing MFs. We show that the degradation of S/N for masked maps is mainly determined by the effective survey area. We also perform simple χ2 analysis to show the impact of lensing MF bias due to masked regions. Finally, we compare ray-tracing simulations with data from a Subaru 2 deg2 survey in order to address if the observed lensing MFs are consistent with those of the standard cosmology. The resulting χ2/n dof = 29.6/30 for three combined MFs, obtained with the mask effects taken into account, suggests that the observational data are indeed consistent with the standard ΛCDM model. We conclude that the lensing MFs are a powerful probe of cosmology only if mask effects are correctly taken into account.

Active mask segmentation of fluorescence microscope images.

PubMed

Srinivasa, Gowri; Fickus, Matthew C; Guo, Yusong; Linstedt, Adam D; Kovacević, Jelena

2009-08-01

We propose a new active mask algorithm for the segmentation of fluorescence microscope images of punctate patterns. It combines the (a) flexibility offered by active-contour methods, (b) speed offered by multiresolution methods, (c) smoothing offered by multiscale methods, and (d) statistical modeling offered by region-growing methods into a fast and accurate segmentation tool. The framework moves from the idea of the "contour" to that of "inside and outside," or masks, allowing for easy multidimensional segmentation. It adapts to the topology of the image through the use of multiple masks. The algorithm is almost invariant under initialization, allowing for random initialization, and uses a few easily tunable parameters. Experiments show that the active mask algorithm matches the ground truth well and outperforms the algorithm widely used in fluorescence microscopy, seeded watershed, both qualitatively, as well as quantitatively.

The dry eye assessment and management (DREAM©) study: Study design and baseline characteristics.

PubMed

Asbell, Penny A; Maguire, Maureen G; Peskin, Ellen; Bunya, Vatinee Y; Kuklinski, Eric J

2018-06-05

Describe trial design and baseline characteristics of participants in the DRy Eye Assessment and Management (DREAM©) Study. Prospective, multi-center, randomized, double-masked "real-world" clinical trial assessing efficacy and safety of oral omega-3 (ω3) supplementation for the treatment of dry eye disease (DED). RESULTS: Mean age of participants was 58.0 ± 13.2 years. Mean OSDI score at baseline was 44.4 ± 14.2. Mean conjunctival staining score (scale 0-6) was 3.0 ± 1.4, corneal staining score (scale 0-15) was 3.9 ± 2.7, tear break-up time was 3.1 ± 1.5 s, and Schirmer test was 9.6 ± 6.5 mm/5 min. DREAM© participants mirror real world patients who seek intervention for their DED-related symptoms despite their current treatments. Results regarding the efficacy of omega-3 supplementation will be helpful to clinicians and patients with moderate to severe DED who are considering omega-3 as a treatment. This trial design may be a model for future RCT's on nutritional supplements and DED treatments seeking to provide useful information for clinical practice. ClinicalTrials.gov number NCT02128763. Copyright © 2017. Published by Elsevier Inc.

Bimatoprost 0.03% for the Treatment of Eyebrow Hypotrichosis

PubMed Central

Beer, Kenneth; Carruthers, Alastair; Coleman, William P.; Draelos, Zoe Diana; Jones, Derek; Goldman, Mitchel P.; Pucci, Michael L.; VanDenburgh, Amanda; Weng, Emily; Whitcup, Scott M.

2016-01-01

BACKGROUND Eyebrow loss may have substantial negative functional and social consequences. OBJECTIVE Evaluate the safety and efficacy of bimatoprost 0.03% in subjects with eyebrow hypotrichosis. METHODS This multicenter, double-masked study randomized adult females or males with eyebrow hypotrichosis to receive bimatoprost 0.03% twice (BID) or once daily (QD) or vehicle BID for 7 months. Primary endpoint was overall eyebrow fullness at Month 7. Secondary endpoints included eyebrow fullness (mm2), darkness (intensity units), and subject satisfaction with treatment. Safety was also assessed. RESULTS At Month 7, the proportion of subjects with improvement was significantly higher in bimatoprost groups versus vehicle (both, p < .001). Improvements occurred in both bimatoprost groups versus vehicle after Month 1 and continued through follow-up; eyebrow fullness and darkness improved as early as Months 2 and 1, respectively (both, p < .001). Greater satisfaction was reported with bimatoprost versus vehicle at Month 2 and all subsequent time points. Overall, 38.1%, 42.4%, and 35.5% of subjects in the bimatoprost BID, QD, and vehicle groups, respectively, experienced ≥1 treatment-emergent adverse event (TEAE). Most frequent TEAEs were similar across groups. No skin or iris hyperpigmentation or conjunctival hyperemia occurred. CONCLUSION Bimatoprost 0.03% BID and QD is safe, well tolerated, and effective for eyebrow hypotrichosis. PMID:27124878

Further enhancement of facial appearance with a hydroquinone skin care system plus tretinoin in patients previously treated with botulinum toxin Type A.

PubMed

Schlessinger, Joel; Kenkel, Jeffrey; Werschler, Philip

2011-07-01

A hydroquinone (HQ) skin care system has been designed for use in conjunction with nonsurgical procedures. The authors evaluate the efficacy of this system plus tretinoin for improving facial appearance in comparison to a standard skin care regimen in users of botulinum toxin Type A (BoNT-A). In this multicenter, randomized, investigator-masked, parallel-group study, 61 patients who received upper facial treatment with BoNT-A at a plastic surgery or dermatology clinic were randomly assigned to apply either the HQ system (cleanser, toner, proprietary 4% hydroquinone, exfoliant, and sunscreen) plus 0.05% tretinoin cream or a standard skin care regimen (cleanser, moisturizer, and sunscreen) for 120 days. Outcomes were assessed by the investigators and through a patient questionnaire. Compared with standard skin care, the HQ system plus tretinoin resulted in significantly milder fine lines/wrinkles and hyperpigmentation at Days 30, 90, and 120 (p ≤ .05) and significantly superior overall ratings for each of nine patient assessments at Days 90 and 120 (p ≤ .05). A relatively greater proportion of patients using the HQ system plus tretinoin believed that their study treatment had further enhanced the improvements attained with BoNT-A (86% vs 8%). Both regimens were generally well tolerated. Adjunctive use of the HQ system plus tretinoin can further enhance the improvements in facial appearance attained with BoNT-A. Applying the HQ system plus tretinoin offers multiple clinical benefits over standard skin care, including significantly greater improvements in fine lines/wrinkles and hyperpigmentation.

Macular pigment density variation after supplementation of lutein and zeaxanthin using the Visucam® 200 pigment module: Impact of age-related macular degeneration and lens status.

PubMed

Azar, G; Quaranta-El Maftouhi, M; Masella, J-J; Mauget-Faÿsse, M

2017-04-01

To assess the evolution of macular pigment optical density (MPOD) following supplementation with various macular formulations obtained with the Visucam ® 200, and to study the factors affecting MPOD measurements. In this prospective, randomized, double-masked multicenter study, patients were divided into 2 groups: group A (patients without retinal pathology who underwent cataract surgery 1 month previously) and group B (patients with neovascular age-related macular degeneration [AMD] in one eye). In each group, half of the patients were randomly assigned to receive a food supplementation either with or without carotenoids (5mg of Lutein and 1mg of Zeaxanthin). Outcome measures included MPOD responses obtained with the Visucam ® 200 for one year. In total, 126 subjects (52 men, 74 women) with a mean age of 75.3±7.61 years were enrolled. Mean MPOD values at the time of inclusion were statistically lower in group A (0.088 density unit [DU]) compared to group B (0.163 DU, P<0.05). No statistically significant increase in MPOD was noted in either group, even after discontinuation of the supplementation. By multiple regression analysis, age, female gender, lens status and the presence of AMD seemed to significantly affect MPOD measurements. No significant improvement in MPOD seems to be detected with the Visucam ® 200 after carotenoid supplementation. The MPOD measurement seems to be highly affected by cataract extraction and the presence of AMD. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Clinical efficacy and safety of a light mask for prevention of dark adaptation in treating and preventing progression of early diabetic macular oedema at 24 months (CLEOPATRA): a multicentre, phase 3, randomised controlled trial.

PubMed

Sivaprasad, Sobha; Vasconcelos, Joana C; Prevost, A Toby; Holmes, Helen; Hykin, Philip; George, Sheena; Murphy, Caroline; Kelly, Joanna; Arden, Geoffrey B

2018-05-01

We aimed to assess 24-month outcomes of wearing an organic light-emitting sleep mask as an intervention to treat and prevent progression of non-central diabetic macular oedema. CLEOPATRA was a phase 3, single-blind, parallel-group, randomised controlled trial undertaken at 15 ophthalmic centres in the UK. Adults with non-centre-involving diabetic macular oedema were randomly assigned (1:1) to wearing either a light mask during sleep (Noctura 400 Sleep Mask, PolyPhotonix Medical, Sedgefield, UK) or a sham (non-light) mask, for 24 months. Randomisation was by minimisation generated by a central web-based computer system. Outcome assessors were masked technicians and optometrists. The primary outcome was the change in maximum retinal thickness on optical coherence tomography (OCT) at 24 months, analysed using a linear mixed-effects model incorporating 4-monthly measurements and baseline adjustment. Analysis was done using the intention-to-treat principle in all randomised patients with OCT data. Safety was assessed in all patients. This trial is registered with Controlled-Trials.com, number ISRCTN85596558. Between April 10, 2014, and June 15, 2015, 308 patients were randomly assigned to wearing the light mask (n=155) or a sham mask (n=153). 277 patients (144 assigned the light mask and 133 the sham mask) contributed to the mixed-effects model over time, including 246 patients with OCT data at 24 months. The change in maximum retinal thickness at 24 months did not differ between treatment groups (mean change -9·2 μm [SE 2·5] for the light mask vs -12·9 μm [SE 2·9] for the sham mask; adjusted mean difference -0·65 μm, 95% CI -6·90 to 5·59; p=0·84). Median compliance with wearing the light mask at 24 months was 19·5% (IQR 1·9-51·6). No serious adverse events were related to either mask. The most frequent adverse events related to the assigned treatment were discomfort on the eyes (14 with the light mask vs seven with the sham mask), painful, sticky, or watery eyes (14 vs six), and sleep disturbance (seven vs one). The light mask as used in this study did not confer long-term therapeutic benefit on non-centre-involving diabetic macular oedema and the study does not support its use for this indication. The Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research partnership. Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Protocol design and current status of CLIVIT: a randomized controlled multicenter relevance trial comparing clips versus ligatures in thyroid surgery

PubMed Central

Seiler, CM; Fröhlich, BE; Veit, JA; Gazyakan, E; Wente, MN; Wollermann, C; Deckert, A; Witte, S; Victor, N; Buchler, MW; Knaebel, HP

2006-01-01

Background Annually, more than 90000 surgical procedures of the thyroid gland are performed in Germany. Strategies aimed at reducing the duration of the surgical procedure are relevant to patients and the health care system especially in the context of reducing costs. However, new techniques for quick and safe hemostasis have to be tested in clinically relevance randomized controlled trials before a general recommendation can be given. The current standard for occlusion of blood vessels in thyroid surgery is ligatures. Vascular clips may be a safe alternative but have not been investigated in a large RCT. Methods/design CLIVIT (Clips versus Ligatures in Thyroid Surgery) is an investigator initiated, multicenter, patient-blinded, two-group parallel relevance randomized controlled trial designed by the Study Center of the German Surgical Society. Patients scheduled for elective resection of at least two third of the gland for benign thyroid disease are eligible for participation. After surgical exploration patients are randomized intraoperatively into either the conventional ligature group, or into the clip group. The primary objective is to test for a relevant reduction in operating time (at least 15 min) when using the clip technique. Since April 2004, 121 of the totally required 420 patients were randomized in five centers. Discussion As in all trials the different forms of bias have to be considered, and as in this case, a surgical trial, the role of surgical expertise plays a key role, and will be documented and analyzed separately. This is the first randomized controlled multicenter relevance trial to compare different vessel occlusion techniques in thyroid surgery with adequate power and other detailed information about the design as well as framework. If significant, the results might be generalized and may change the current surgical practice. PMID:16948853

Change in clinical indices following laser or scalpel treatment for periodontitis: A split-mouth, randomized, multi-center trial

NASA Astrophysics Data System (ADS)

Harris, David M.; Nicholson, Dawn M.; McCarthy, Delwin; Yukna, Raymond A.; Reynolds, Mark A.; Greenwell, Henry; Finley, James; McCawley, Thomas K.; Xenoudi, Pinelopi; Gregg, Robert H.

2014-02-01

Data are presented from a multi-center, prospective, longitudinal, clinical trial comparing four different treatments for periodontitis, (1) the LANAPTM protocol utilizing a FR pulsed-Nd:YAG laser; (2) flap surgery using the Modified Widman technique (MWF); (3) traditional scaling and root planing (SRP); and (4) coronal debridement (CD). Each treatment was randomized to a different quadrant. Fifty-one (54) subjects were recruited at five centers that included both private practice and university-based investigators. At 6-months and 12 months post-treatment the LANAPTM protocol and MWF yielded equivalent results based on changes in probing depths. The major difference observed between the two procedures was that patients reported significantly greater comfort following the LANAP™ procedure than following the MWF (P<0.001). There was greater reduction in bleeding in the LANAPTM quadrant than in the other three at both 6 and 12 months. Improvements following SRP were better than expected at 6 months and continued to improve, providing outcomes that were equivalent to both LANAPTM and MWF at 12 months. The improvement in the SRP quadrants suggests the hypothesis that an aspect of the LANAPTM protocol generated a significant, positive and unanticipated systemic (or trans-oral) effect on sub-gingival wound healing.

Calcium Hydroxylapatite Dermal Filler for Treatment of Dorsal Hand Volume Loss: Results From a 12-Month, Multicenter, Randomized, Blinded Trial.

PubMed

Goldman, Mitchel P; Moradi, Amir; Gold, Michael H; Friedmann, Daniel P; Alizadeh, Kaveh; Adelglass, Jeffrey M; Katz, Bruce E

2018-01-01

Calcium hydroxylapatite (CaHA) microspheres suspended in a carrier gel is an opaque dermal filler that has been used to provide immediate volume correction in the dorsal hands. To assess the safety and effectiveness of CaHA for the correction of volume loss in the hands up to 12 months. This multicenter, controlled, single-blind study (NCT01832090) included 114 subjects randomized 3:1 to CaHA treatment and untreated control groups. Effectiveness was assessed by blinded investigators using the validated Merz Hand Grading Scale (MHGS). Subject-reported improvement was assessed using the Global Aesthetic Improvement Scale. Effects of treatment on hand function were also assessed. A total of 75% of subjects achieved ≥1-point improvement on the MHGS (p < .0001) at 3 months (primary end point); this response was generally maintained through 12 months. Proportions of subjects reporting improvement ranged from 98% (3 months) to 86% (12 months). There were no clinically significant differences between control and CaHA-treated subjects in any hand function measure. Adverse events were generally expected, minor, short-lived, injection-related, and similar to those observed in previous CaHA clinical studies. Treatment with CaHA results in significant improvement in the appearance of the dorsal hand and is well tolerated.

Results of a Multicenter, Randomized, Controlled Trial of a Hydrogen Peroxide-based Kit versus a Benzoyl Peroxide-based Kit in Mild-to-moderate Acne

PubMed Central

Micali, Giuseppe; Berardesca, Enzo; Dall’Oglio, Federica; Sinagra, Jo Linda; Guanziroli, Elena

2016-01-01

Objective:To evaluate the efficacy and tolerability of a novel hydrogen peroxide-based regimen versus a benzoyl peroxide-based regimen in mild-to-moderate acne. Methods: In this eight-week multicenter study, patients were randomized to either a hydrogen peroxide-based or a benzoyl peroxide-based regimen.The primary outcome measure of clinical response was assessed using the Global Acne Grading System (GAGS) at baseline,four weeks, and eight weeks. At Week 8, a patient self-satisfaction questionnaire was administered. Investigators were also queried at that time regarding assessment of tolerability and cosmetic acceptability. Tolerability was also measured at each visit. Results: Both treatment regimens were associated with improvement of GAGS score at Week 8 compared to baseline (p<0.0001). GAGS score did not differ significantly between the two regimens over the same period (p=0.7765). No significant adverse events were reported or observed in either treatment arm. Both patients and investigators found both regimens to be similarly effective and cosmetically acceptable. Conclusion: A novel hydrogen peroxide-based regimen was shown to be comparable in efficacy, safety, and cosmetic acceptability to a benzoyl peroxide-based regimen in the treatment of mild-to-moderate acne. PMID:27847549

Cerebral Oximetry Monitoring to Maintain Normal Cerebral Oxygen Saturation during High-risk Cardiac Surgery: A Randomized Controlled Feasibility Trial.

PubMed

Deschamps, Alain; Hall, Richard; Grocott, Hilary; Mazer, C David; Choi, Peter T; Turgeon, Alexis F; de Medicis, Etienne; Bussières, Jean S; Hudson, Christopher; Syed, Summer; Seal, Doug; Herd, Stuart; Lambert, Jean; Denault, André; Deschamps, Alain; Mutch, Alan; Turgeon, Alexis; Denault, Andre; Todd, Andrea; Jerath, Angela; Fayad, Ashraf; Finnegan, Barry; Kent, Blaine; Kennedy, Brent; Cuthbertson, Brian H; Kavanagh, Brian; Warriner, Brian; MacAdams, Charles; Lehmann, Christian; Fudorow, Christine; Hudson, Christopher; McCartney, Colin; McIsaac, Dan; Dubois, Daniel; Campbell, David; Mazer, David; Neilpovitz, David; Rosen, David; Cheng, Davy; Drapeau, Dennis; Dillane, Derek; Tran, Diem; Mckeen, Dolores; Wijeysundera, Duminda; Jacobsohn, Eric; Couture, Etienne; de Medicis, Etienne; Alam, Fahad; Abdallah, Faraj; Ralley, Fiona E; Chung, Frances; Lellouche, Francois; Dobson, Gary; Germain, Genevieve; Djaiani, George; Gilron, Ian; Hare, Gregory; Bryson, Gregory; Clarke, Hance; McDonald, Heather; Roman-Smith, Helen; Grocott, Hilary; Yang, Homer; Douketis, James; Paul, James; Beaubien, Jean; Bussières, Jean; Pridham, Jeremy; Armstrong, J N; Parlow, Joel; Murkin, John; Gamble, Jonathan; Duttchen, Kaylene; Karkouti, Keyvan; Turner, Kim; Baghirzada, Leyla; Szabo, Linda; Lalu, Manoj; Wasowicz, Marcin; Bautista, Michael; Jacka, Michael; Murphy, Michael; Schmidt, Michael; Verret, Michaël; Perrault, Michel-Antoine; Beaudet, Nicolas; Buckley, Norman; Choi, Peter; MacDougall, Peter; Jones, Philip; Drolet, Pierre; Beaulieu, Pierre; Taneja, Ravi; Martin, Rene; Hall, Richard; George, Ronald; Chun, Rosa; McMullen, Sarah; Beattie, Scott; Sampson, Sonia; Choi, Stephen; Kowalski, Stephen; McCluskey, Stuart; Syed, Summer; Boet, Sylvain; Ramsay, Tim; Saha, Tarit; Mutter, Thomas; Chowdhury, Tumul; Uppal, Vishal; Mckay, William

2016-04-01

Cerebral oxygen desaturation during cardiac surgery has been associated with adverse perioperative outcomes. Before a large multicenter randomized controlled trial (RCT) on the impact of preventing desaturations on perioperative outcomes, the authors undertook a randomized prospective, parallel-arm, multicenter feasibility RCT to determine whether an intervention algorithm could prevent desaturations. Eight Canadian sites randomized 201 patients between April 2012 and October 2013. The primary outcome was the success rate of reversing cerebral desaturations below 10% relative to baseline in the intervention group. Anesthesiologists were blinded to the cerebral saturation values in the control group. Intensive care unit personnel were blinded to cerebral saturation values for both groups. Secondary outcomes included the area under the curve of cerebral desaturation load, enrolment rates, and a 30-day follow-up for adverse events. Cerebral desaturations occurred in 71 (70%) of the 102 intervention group patients and 56 (57%) of the 99 control group patients (P = 0.04). Reversal was successful in 69 (97%) of the intervention group patients. The mean cerebral desaturation load (SD) in the operating room was smaller for intervention group patients compared with control group patients (104 [217] %.min vs. 398 [869] %.min, mean difference, -294; 95% CI, -562 to -26; P = 0.03). This was also true in the intensive care unit (P = 0.02). There were no differences in adverse events between the groups. Study sites were successful in reversal of desaturation, patient recruitment, randomization, and follow-up in cardiac surgery, supporting the feasibility of conducting a large multicenter RCT.

The influence of facial masking and sex on older adults' impressions of individuals with Parkinson's disease.

PubMed

Hemmesch, Amanda R; Tickle-Degnen, Linda; Zebrowitz, Leslie A

2009-09-01

Parkinson's disease (PD) involves facial masking, which may impair social interaction. Older adult observers who viewed segments of videotaped interviews of individuals with PD expressed less interest in relationships with women with higher masking and judged them as less supportive. Masking did not affect ratings of men in these domains, possibly because higher masking violates gender norms for expressivity in women but not in men. Observers formed less accurate ratings of the social supportiveness and social strain of women than men, and higher masking decreased accuracy for ratings of strain. Results suggest that some of the problems with social relationships in PD may be due to inaccurate impressions and reduced desire to interact with individuals with higher masking, especially women. (c) 2009 APA, all rights reserved.

Ensuring Confidentiality of Geocoded Health Data: Assessing Geographic Masking Strategies for Individual-Level Data.

PubMed

Zandbergen, Paul A

2014-01-01

Public health datasets increasingly use geographic identifiers such as an individual's address. Geocoding these addresses often provides new insights since it becomes possible to examine spatial patterns and associations. Address information is typically considered confidential and is therefore not released or shared with others. Publishing maps with the locations of individuals, however, may also breach confidentiality since addresses and associated identities can be discovered through reverse geocoding. One commonly used technique to protect confidentiality when releasing individual-level geocoded data is geographic masking. This typically consists of applying a certain amount of random perturbation in a systematic manner to reduce the risk of reidentification. A number of geographic masking techniques have been developed as well as methods to quantity the risk of reidentification associated with a particular masking method. This paper presents a review of the current state-of-the-art in geographic masking, summarizing the various methods and their strengths and weaknesses. Despite recent progress, no universally accepted or endorsed geographic masking technique has emerged. Researchers on the other hand are publishing maps using geographic masking of confidential locations. Any researcher publishing such maps is advised to become familiar with the different masking techniques available and their associated reidentification risks.

Feasibility of retinoids for the treatment of emphysema study.

PubMed

Roth, Michael D; Connett, John E; D'Armiento, Jeanine M; Foronjy, Robert F; Friedman, Paul J; Goldin, Jonathan G; Louis, Thomas A; Mao, Jenny T; Muindi, Josephia R; O'Connor, George T; Ramsdell, Joe W; Ries, Andrew L; Scharf, Steven M; Schluger, Neil W; Sciurba, Frank C; Skeans, Melissa A; Walter, Robert E; Wendt, Christine H; Wise, Robert A

2006-11-01

Retinoids promote alveolar septation in the developing lung and stimulate alveolar repair in some animal models of emphysema. One hundred forty-eight subjects with moderate-to-severe COPD and a primary component of emphysema, defined by diffusing capacity of the lung for carbon monoxide (Dlco) [37.1 +/- 12.0% of predicted] and CT density mask (38.5 +/- 12.8% of voxels <- 910 Hounsfield units) [mean +/- SD] were enrolled into a randomized, double-blind, feasibility study at five university hospitals. Participants received all-trans retinoic acid (ATRA) at either a low dose (LD) [1 mg/kg/d] or high dose (HD) [2 mg/kg/d], 13-cis retinoic acid (13-cRA) [1 mg/kg/d], or placebo for 6 months followed by a 3-month crossover period. No treatment was associated with an overall improvement in pulmonary function, CT density mask score, or health-related quality of life (QOL) at the end of 6 months. However, time-dependent changes in Dlco (initial decrease with delayed recovery) and St. George Respiratory Questionnaire (delayed improvement) were observed in the HD-ATRA cohort and correlated with plasma drug levels. In addition, 5 of 25 participants in the HD-ATRA group had delayed improvements in their CT scores that also related to ATRA levels. Retinoid-related side effects were common but generally mild. No definitive clinical benefits related to the administration of retinoids were observed in this feasibility study. However, time- and dose-dependent changes in Dlco, CT density mask score, and health-related QOL were observed in subjects treated with ATRA, suggesting the possibility of exposure-related biological activity that warrants further investigation.

Multiresolution multiscale active mask segmentation of fluorescence microscope images

NASA Astrophysics Data System (ADS)

Srinivasa, Gowri; Fickus, Matthew; Kovačević, Jelena

2009-08-01

We propose an active mask segmentation framework that combines the advantages of statistical modeling, smoothing, speed and flexibility offered by the traditional methods of region-growing, multiscale, multiresolution and active contours respectively. At the crux of this framework is a paradigm shift from evolving contours in the continuous domain to evolving multiple masks in the discrete domain. Thus, the active mask framework is particularly suited to segment digital images. We demonstrate the use of the framework in practice through the segmentation of punctate patterns in fluorescence microscope images. Experiments reveal that statistical modeling helps the multiple masks converge from a random initial configuration to a meaningful one. This obviates the need for an involved initialization procedure germane to most of the traditional methods used to segment fluorescence microscope images. While we provide the mathematical details of the functions used to segment fluorescence microscope images, this is only an instantiation of the active mask framework. We suggest some other instantiations of the framework to segment different types of images.

Efficacy and safety of pentavalent rotavirus vaccine in Japan: a randomized, double-blind, placebo-controlled, multicenter trial.

PubMed

Iwata, Satoshi; Nakata, Shuji; Ukae, Susumu; Koizumi, Yoshitugu; Morita, Yasuyuki; Kuroki, Haruo; Tanaka, Yoshiyuki; Shizuya, Toshiyuki; Schödel, Florian; Brown, Michelle L; Lawrence, Jody

2013-08-01

Rotavirus is the most common cause of severe gastroenteritis in children under 5 y of age. Estimates of disease burden in Japan suggest that between 26,500 and 78,000 children in this age group need hospitalization each year, resulting in a direct medical cost of 10 to 24 billion Yen. Since being introduced in routine infant immunization schedules in the United States in 2006, the oral live pentavalent rotavirus vaccine RV5 (RotaTeq™) has contributed to dramatic reductions in the incidence of rotavirus gastroenteritis (RVGE) and in health care resource utilization. This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of a 3-dose regimen of RV5 in healthy infants, age 6 to 12 weeks, at 32 sites across Japan. The results indicate that RV5 was significantly efficacious in preventing any severity [74.5% (95% confidence interval [CI]: 39.9%, 90.6%; p<0.001)], moderate-to-severe [80.2% (95% CI: 47.4%, 94.1%)], and severe [100% (95% CI: 55.4%, 100%)] RVGE caused by viruses with serotypes contained in the vaccine. The observed cases of RVGE included rotavirus types G1 (n=19), G3 (n=9), G9 (n=5) and one unspecified G serotype with P1A[8]. No G2 or G4 RVGE cases were observed, and this study was not powered to evaluate efficacy against individual serotypes. RV5 was generally safe and well tolerated in Japanese infants. These results are comparable to those observed in clinical studies conducted in other developed countries. Introduction of the vaccine in Japan may reduce disease burden and associated health care costs.

Effects of a modified through-mask drinking system (MDS) on fluid intake during exercise in chemical protective gear. Report for January-May 1989

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

Szlyk, P.C.; Sils, I.V.; Tharion, W.J.

This study was designed to evaluate the effects of a modified through-mask drinking system (MDS) on voluntary fluid consumption. Eighteen male volunteers walked on a treadmill (4.02 km/hr, 0 deg. grade, 50 min/hr for 6 hr) in a climatic chamber (dry bulb=32.6 deg C, wet bulb=17.5 deg C, 20.4% relative humidity, and windspeed=8.05 km/hr, producing a WBGT of 22.1 deg C). Subjects wore chemical protective gear (trousers, jacket, boots, gloves, and M17A1 protective mask) and were randomly assigned one of two through-mask and were randomly assigned one of two through-mask drinking systems: CS (n=9), the current gravity fed system ormore » MDS (n=9), a prototype hand-pump drinking system. Because decontamination of the mask and drinking connections was performed prior to drinking, the overall use of the CS was rated significantly more difficult during both work and rest than the MDS. Failure to decontaminate connections prior to drinking was noted early in the trial in 2 soldiers using the CS suggesting an increase risk of accidental contamination associated with this system. Drinking with the MDS had no measurable adverse effect on hydration status of the test subjects: water intake rate, 0.36 L/hr (CS) and 0.42 L/hr (MDS); sweat rate, 0.63 L/hr (CS) and 0.67 L/hr (MDS); body weight loss, 0.32 %/hr (CS) and 0.31 %/hr (MDS).« less

Phase-retrieval attack free cryptosystem based on cylindrical asymmetric diffraction and double-random phase encoding

NASA Astrophysics Data System (ADS)

Wang, Jun; Li, Xiaowei; Hu, Yuhen; Wang, Qiong-Hua

2018-03-01

A phase-retrieval attack free cryptosystem based on the cylindrical asymmetric diffraction and double-random phase encoding (DRPE) is proposed. The plaintext is abstract as a cylinder, while the observed diffraction and holographic surfaces are concentric cylinders. Therefore, the plaintext can be encrypted through a two-step asymmetric diffraction process with double pseudo random phase masks located on the object surface and the first diffraction surface. After inverse diffraction from a holographic surface to an object surface, the plaintext can be reconstructed using a decryption process. Since the diffraction propagated from the inner cylinder to the outer cylinder is different from that of the reversed direction, the proposed cryptosystem is asymmetric and hence is free of phase-retrieval attack. Numerical simulation results demonstrate the flexibility and effectiveness of the proposed cryptosystem.

Effect of metronome rates on the quality of bag-mask ventilation during metronome-guided 30:2 cardiopulmonary resuscitation: A randomized simulation study.

PubMed

Na, Ji Ung; Han, Sang Kuk; Choi, Pil Cho; Shin, Dong Hyuk

2017-01-01

Metronome guidance is a feasible and effective feedback technique to improve the quality of cardiopulmonary resuscitation (CPR). The rate of the metronome should be set between 100 to 120 ticks/minute and the speed of ventilation may have crucial effect on the quality of ventilation. We compared three different metronome rates (100, 110, 120 ticks/minute) to investigate its effect on the quality of ventilation during metronome-guided 30:2 CPR. This is a prospective, randomized, crossover observational study using a RespiTrainer○ r . To simulate 30 chest compressions, one investigator counted from 1 to 30 in cadence with the metronome rate (1 count for every 1 tick), and the participant performed 2 consecutive ventilations immediately following the counting of 30. Thirty physicians performed 5 sets of 2 consecutive (total 10) bag-mask ventilations for each metronome rate. Participants were instructed to squeeze the bag over 2 ticks (1.0 to 1.2 seconds depending on the rate of metronome) and deflate the bag over 2 ticks. The sequence of three different metronome rates was randomized. Mean tidal volume significantly decreased as the metronome rate was increased from 110 ticks/minute to 120 ticks/minute (343±84 mL vs. 294±90 mL, P =0.004). Peak airway pressure significantly increased as metronome rate increased from 100 ticks/minute to 110 ticks/minute (18.7 vs. 21.6 mmHg, P =0.006). In metronome-guided 30:2 CPR, a higher metronome rate may adversely affect the quality of bag-mask ventilations. In cases of cardiac arrest where adequate ventilation support is necessary, 100 ticks/minute may be better than 110 or 120 ticks/minute to deliver adequate tidal volume during audio tone guided 30:2 CPR.

Effect of metronome rates on the quality of bag-mask ventilation during metronome-guided 30:2 cardiopulmonary resuscitation: A randomized simulation study

PubMed Central

Na, Ji Ung; Han, Sang Kuk; Choi, Pil Cho; Shin, Dong Hyuk

2017-01-01

BACKGROUND: Metronome guidance is a feasible and effective feedback technique to improve the quality of cardiopulmonary resuscitation (CPR). The rate of the metronome should be set between 100 to 120 ticks/minute and the speed of ventilation may have crucial effect on the quality of ventilation. We compared three different metronome rates (100, 110, 120 ticks/minute) to investigate its effect on the quality of ventilation during metronome-guided 30:2 CPR. METHODS: This is a prospective, randomized, crossover observational study using a RespiTrainer○r. To simulate 30 chest compressions, one investigator counted from 1 to 30 in cadence with the metronome rate (1 count for every 1 tick), and the participant performed 2 consecutive ventilations immediately following the counting of 30. Thirty physicians performed 5 sets of 2 consecutive (total 10) bag-mask ventilations for each metronome rate. Participants were instructed to squeeze the bag over 2 ticks (1.0 to 1.2 seconds depending on the rate of metronome) and deflate the bag over 2 ticks. The sequence of three different metronome rates was randomized. RESULTS: Mean tidal volume significantly decreased as the metronome rate was increased from 110 ticks/minute to 120 ticks/minute (343±84 mL vs. 294±90 mL, P=0.004). Peak airway pressure significantly increased as metronome rate increased from 100 ticks/minute to 110 ticks/minute (18.7 vs. 21.6 mmHg, P=0.006). CONCLUSION: In metronome-guided 30:2 CPR, a higher metronome rate may adversely affect the quality of bag-mask ventilations. In cases of cardiac arrest where adequate ventilation support is necessary, 100 ticks/minute may be better than 110 or 120 ticks/minute to deliver adequate tidal volume during audio tone guided 30:2 CPR. PMID:28458759

EFFECT OF MASKED REGIONS ON WEAK-LENSING STATISTICS

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

Shirasaki, Masato; Yoshida, Naoki; Hamana, Takashi, E-mail: masato.shirasaki@utap.phys.s.u-tokyo.ac.jp

2013-09-10

Sky masking is unavoidable in wide-field weak-lensing observations. We study how masks affect the measurement of statistics of matter distribution probed by weak gravitational lensing. We first use 1000 cosmological ray-tracing simulations to examine in detail the impact of masked regions on the weak-lensing Minkowski Functionals (MFs). We consider actual sky masks used for a Subaru Suprime-Cam imaging survey. The masks increase the variance of the convergence field and the expected values of the MFs are biased. The bias then compromises the non-Gaussian signals induced by the gravitational growth of structure. We then explore how masks affect cosmological parameter estimation.more » We calculate the cumulative signal-to-noise ratio (S/N) for masked maps to study the information content of lensing MFs. We show that the degradation of S/N for masked maps is mainly determined by the effective survey area. We also perform simple {chi}{sup 2} analysis to show the impact of lensing MF bias due to masked regions. Finally, we compare ray-tracing simulations with data from a Subaru 2 deg{sup 2} survey in order to address if the observed lensing MFs are consistent with those of the standard cosmology. The resulting {chi}{sup 2}/n{sub dof} = 29.6/30 for three combined MFs, obtained with the mask effects taken into account, suggests that the observational data are indeed consistent with the standard {Lambda}CDM model. We conclude that the lensing MFs are a powerful probe of cosmology only if mask effects are correctly taken into account.« less

Implant and prosthesis movement after enucleation: a randomized controlled trial.

PubMed

Shome, Debraj; Honavar, Santosh G; Raizada, Kuldeep; Raizada, Deepa

2010-08-01

To evaluate implant and prosthesis movement after myoconjunctival enucleation and subsequent polymethyl methacrylate (PMMA) implantation, compared with the traditional enucleation with muscle imbrication using a PMMA implant and with enucleation accompanied by porous polyethylene implantation. Randomized, controlled, observer-masked, interventional study. One hundred fifty patients, equally and randomly allocated to the 3 groups. Group 1 consisted of patients in whom a PMMA implant was used after enucleation with muscle imbrication (traditional PMMA group). Group 2 consisted of patients in whom a PMMA implant was used after enucleation with a myoconjunctival technique (myoconjunctival PMMA group). Group 3 consisted of patients in whom a porous polyethylene implant was used after enucleation by the scleral cap technique (porous polyethylene group). Fifty patients were included in each group. Patients were allocated to 1 of the 3 groups using stratified randomization. Informed consent was obtained. Acrylic prostheses custom made by a trained ocularist were fitted 6 weeks after surgery in all patients. A masked observer measured implant and prosthesis movement 6 weeks after surgery using a slit-lamp device with real-time video and still photographic documentation. Analysis of implant and prosthesis movement was carried out using the Mann-Whitney U test, and a P value of < or =0.03 was considered significant. Complications including implant displacement and exposure also were noted. Implant and prosthesis movement. Myoconjunctival PMMA implant movement was better than the traditional PMMA implant (P = 0.001), but was similar to that of the porous polyethylene implant. Prosthesis movement with the myoconjunctival PMMA implant was better than that of either the traditional PMMA (P = 0.001) or porous polyethylene (P = 0.002) implants. Myoconjunctival enucleation technique with a PMMA implant provides statistically and clinically significantly better implant and prosthesis movement than the traditional PMMA implant and better prosthesis movement than the porous polyethylene implant. Copyright 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Competing for Consciousness: Prolonged Mask Exposure Reduces Object Substitution Masking

ERIC Educational Resources Information Center

Goodhew, Stephanie C.; Visser, Troy A. W.; Lipp, Ottmar V.; Dux, Paul E.

2011-01-01

In object substitution masking (OSM) a sparse, temporally trailing 4-dot mask impairs target identification, even though it has different contours from, and does not spatially overlap with the target. Here, we demonstrate a previously unknown characteristic of OSM: Observers show reduced masking at prolonged (e.g., 640 ms) relative to intermediate…

Nonconscious Influence of Masked Stimuli on Response Selection Is Limited to Concrete Stimulus-Response Associations

ERIC Educational Resources Information Center

Klapp, Stuart T.; Haas, Brian W.

2005-01-01

A pattern-masked arrow negatively biased the "free choice" between 2 manual responses or between 2 vocal responses. This apparently nonconscious influence occurred only when the free-choice trials were intermixed randomly with other trials that terminated in fully visible arrows, which directed a response of the same modality (manual vs. vocal) as…

Efficacy of a new device to optimize positive pressure ventilation via face mask in edentulous patients: a randomized trial.

PubMed

Niño, Maria C; Pauwels, Andres; Raffan, Fernando; Arango, Enrique; Romero, David J; Benitez, Daniel

2017-04-01

Mask ventilation is routinely performed during anesthesia. Under some circumstances, it might be difficult to perform, such as in edentulous patients, due to inadequate mask seal. We developed a new device called NIPARA and studied its use For ventilation optimization in edentulous patients. This randomized controlled trial included edentulous adults who had no other predictors of difficult airway, scheduled to undergo general anesthesia. Patients were assigned either to the NIPARA device group or to the control group (oral airway only). The primary outcomes were peak inspiratory pressure and tidal volume values of the first 14 breaths. The secondary outcome was the incidence of complications. Data from 37 patients were collected during a one-year period (twenty in the NIPARA device group and 17 in the control group). The difference in mean PIP was not statistically significant. The tidal volume was 1.5 times greater in the NIPARA group than in the control group. One patient from the intervention group had minimal oral trauma. In the administration of face mask ventilation, NIPARA is an effective device that significantly improves the tidal volume administered in edentulous patients.

Rationale, challenges, and participants in a Phase II trial of a botanical product for chronic hepatitis C

PubMed Central

Belle, Steven H; Fried, Michael W; Afdhal, Nezam; Navarro, Victor J; Hawke, Roy L; Wahed, Abdus S; Doo, Edward; Meyers, Catherine M

2012-01-01

Background Chronic hepatitis C is associated with significant morbidity and mortality as a consequence of progression to cirrhosis, hepatocellular carcinoma, and liver failure. Current treatment for chronic hepatitis C with pegylated interferon (IFN) and ribavirin is associated with suboptimal responses and numerous adverse effects. A number of botanical products have been used to treat hepatic disorders. Silymarin, extracted from the milk thistle plant, Silybum marianum (L) Gaertn. (Asteraceae), has been most widely used for various liver disorders, including chronic hepatitis C, B, and alcoholic liver disease. However, the safety and efficacy of silymarin have not been studied systematically in chronic hepatitis C. Purpose We describe our strategy for a phased approach for studying the impact of silymarin in hepatitis C, in the context of the unique challenges of botanical product clinical trials and the development of specific and curative antiviral therapy. Methods This multicenter, randomized, double-masked, placebo-controlled trial was conducted with four clinical centers and a data-coordinating center in the United States, to assess the impact of silymarin therapy in patients with chronic hepatitis C who failed conventional antiviral therapy. Results Key aspects relevant to performing clinical trials of botanical products include early identification of an appropriate product with standard product chemistry, acquisition of pharmacokinetic and dosing information, selection of the appropriate study group, and choosing rigorous outcome variables. Potential limitations Trial participants were chronic hepatitis C patients who were nonsustained virologic responders to IFN-based therapy; therefore, the findings are not generalizable to all hepatitis C populations. Further, alanine aminotransferase, a biochemical liver test, rather than hepatitis viral RNA or liver histology was the primary end point. Conclusions The challenges identified and addressed during development of this United States multicenter Phase II trial to evaluate silymarin for treatment of patients with chronic hepatitis C infection who had failed to respond successfully to previous IFN-based therapy are common and must be addressed to conduct rigorous trials of botanical products. PMID:22058086

Rationale, challenges, and participants in a Phase II trial of a botanical product for chronic hepatitis C.

PubMed

Reddy, K Rajender; Belle, Steven H; Fried, Michael W; Afdhal, Nezam; Navarro, Victor J; Hawke, Roy L; Wahed, Abdus S; Doo, Edward; Meyers, Catherine M

2012-02-01

Chronic hepatitis C is associated with significant morbidity and mortality as a consequence of progression to cirrhosis, hepatocellular carcinoma, and liver failure. Current treatment for chronic hepatitis C with pegylated interferon (IFN) and ribavirin is associated with suboptimal responses and numerous adverse effects. A number of botanical products have been used to treat hepatic disorders. Silymarin, extracted from the milk thistle plant, Silybum marianum (L) Gaertn. (Asteraceae), has been most widely used for various liver disorders, including chronic hepatitis C, B, and alcoholic liver disease. However, the safety and efficacy of silymarin have not been studied systematically in chronic hepatitis C. We describe our strategy for a phased approach for studying the impact of silymarin in hepatitis C, in the context of the unique challenges of botanical product clinical trials and the development of specific and curative antiviral therapy. This multicenter, randomized, double-masked, placebo-controlled trial was conducted with four clinical centers and a data-coordinating center in the United States, to assess the impact of silymarin therapy in patients with chronic hepatitis C who failed conventional antiviral therapy. Key aspects relevant to performing clinical trials of botanical products include early identification of an appropriate product with standard product chemistry, acquisition of pharmacokinetic and dosing information, selection of the appropriate study group, and choosing rigorous outcome variables. POTENTIAL LIMITATIONS: Trial participants were chronic hepatitis C patients who were nonsustained virologic responders to IFN-based therapy; therefore, the findings are not generalizable to all hepatitis C populations. Further, alanine aminotransferase, a biochemical liver test, rather than hepatitis viral RNA or liver histology was the primary end point. The challenges identified and addressed during development of this United States multicenter Phase II trial to evaluate silymarin for treatment of patients with chronic hepatitis C infection who had failed to respond successfully to previous IFN-based therapy are common and must be addressed to conduct rigorous trials of botanical products.

Latent Subgroup Analysis of a Randomized Clinical Trial Through a Semiparametric Accelerated Failure Time Mixture Model

PubMed Central

Altstein, L.; Li, G.

2012-01-01

Summary This paper studies a semiparametric accelerated failure time mixture model for estimation of a biological treatment effect on a latent subgroup of interest with a time-to-event outcome in randomized clinical trials. Latency is induced because membership is observable in one arm of the trial and unidentified in the other. This method is useful in randomized clinical trials with all-or-none noncompliance when patients in the control arm have no access to active treatment and in, for example, oncology trials when a biopsy used to identify the latent subgroup is performed only on subjects randomized to active treatment. We derive a computational method to estimate model parameters by iterating between an expectation step and a weighted Buckley-James optimization step. The bootstrap method is used for variance estimation, and the performance of our method is corroborated in simulation. We illustrate our method through an analysis of a multicenter selective lymphadenectomy trial for melanoma. PMID:23383608

Imaging in laser spectroscopy by a single-pixel camera based on speckle patterns

NASA Astrophysics Data System (ADS)

Žídek, K.; Václavík, J.

2016-11-01

Compressed sensing (CS) is a branch of computational optics able to reconstruct an image (or any other information) from a reduced number of measurements - thus significantly saving measurement time. It relies on encoding the detected information by a random pattern and consequent mathematical reconstruction. CS can be the enabling step to carry out imaging in many time-consuming measurements. The critical step in CS experiments is the method to invoke encoding by a random mask. Complex devices and relay optics are commonly used for the purpose. We present a new approach of creating the random mask by using laser speckles from coherent laser light passing through a diffusor. This concept is especially powerful in laser spectroscopy, where it does not require any complicated modification of the current techniques. The main advantage consist in the unmatched simplicity of the random pattern generation and a versatility of the pattern resolution. Unlike in the case of commonly used random masks, here the pattern fineness can be adjusted by changing the laser spot size being diffused. We demonstrate the pattern tuning together with the connected changes in the pattern statistics. In particular, the issue of patterns orthogonality, which is important for the CS applications, is discussed. Finally, we demonstrate on a set of 200 acquired speckle patterns that the concept can be successfully employed for single-pixel camera imaging. We discuss requirements on detector noise for the image reconstruction.

Prevalence of masked uncontrolled hypertension according to the number of office blood pressure measurements.

PubMed

Vinyoles, E; Camafort, M; Domenech, M; Coca, A; Sobrino, J

2015-11-01

The reported prevalence of masked uncontrolled hypertension (MUCH) varies because many studies are not comparable as they use different measurement methodologies. To evaluate the influence of the number of office blood pressure readings on the prevalence of MUCH we conducted a cross-sectional, multicenter study in treated hypertensive patients. We carried out an observational, cross-sectional, multicenter study in 33 Spanish hospital-based hypertension units, involving 35 investigators and 12 Autonomous Communities. Six blood pressure readings and a 24-h ambulatory blood pressure monitoring were performed in treated hypertensive patients. The means of the first 3 readings (P123), the 2nd, 3rd and 4th readings (P234), the 3rd, 4th and 5th readings (P345) and the last 3 readings (P456) were compared with mean 24-h blood pressure. MUCH was defined as office blood pressure <140/90mmHg and 24-h blood pressure ≥130/80mmHg, considering the first 3 readings (MUCH123), the 2nd, 3rd and 4th readings (MUCH234), the 3rd, 4th and 5th readings (MUCH345) and the last 3 readings (MUCH456). We included 498 hypertensive patients. Mean (standard deviation) office blood pressure measurements were: (P123) 141(18)/82(11); (P234) 139(17)/81(11); (P345) 138(17)/81(11) and (P456) 137(16)/80(10) mmHg. Mean 24-h blood pressure was 127(13.8)/75(9.5) mmHg. The correlation coefficients between ambulatory and office systolic/diastolic blood pressure were (P123):0.48/0.50; (P234):0.50/0.52; (P345):0.50/0.54; and (P456):0.50/0.55 (p<0.001, all). The prevalences of MUCH123, MUCH234, MUCH345 and MUCH456 were 14.5%, 18.9%, 19.5% and 21.1%, respectively. The prevalence of MUCH diagnosis depends on the serial office blood pressure readings, being much higher for the last three blood pressure readings. Discarding the first and second office blood pressure measures seems to be the most accurate method for diagnosing MUCH. Copyright © 2015 Elsevier España, S.L.U. y Sociedad Española de Medicina Interna (SEMI). All rights reserved.

[Design of a multicenter study for assessing the effectiveness of extracorporeal shockwave therapy in epicondylitis humeri radialis].

PubMed

Haake, M; Jensen, K; Prinz, H; Willenberg, T

2000-01-01

Previously published studies concerning, extracorporeal shock-wave therapy (ESWT) in the treatment of lateral epicondylitis do not fulfil the biometric standards of modern clinical research. The objective of the trial is to show that ESWT is effective in the treatment of chronic LE. A prospective, randomized, placebo-controlled, single-blinded, multicenter trial with an independent blinded observer was designed. The effectiveness of ESWT is evaluated by comparison with a control group in which sham-ESWT is performed, both under local anaesthesia. Outcome is determined on the basis of the Roles/Maudsley-Score. Inclusion criteria are a history of at least 6 months of LE and failure of conventional treatment. The therapy includes 3 sessions of low energy ESWT with 2000 impulses (energy flux density 0.07-0.09 mJ/mm2). Sample size is 272 patients. Randomisation started in October 1998 and is planned over a period of two and a half years. Only a randomised clinical trial with adequate control of placebo effects and observer bias can provide the required evidence for the efficiency of ESWT in the treatment of lateral epicondylitis of the elbow.

Secure information display with limited viewing zone by use of multi-color visual cryptography.

PubMed

Yamamoto, Hirotsugu; Hayasaki, Yoshio; Nishida, Nobuo

2004-04-05

We propose a display technique that ensures security of visual information by use of visual cryptography. A displayed image appears as a completely random pattern unless viewed through a decoding mask. The display has a limited viewing zone with the decoding mask. We have developed a multi-color encryption code set. Eight colors are represented in combinations of a displayed image composed of red, green, blue, and black subpixels and a decoding mask composed of transparent and opaque subpixels. Furthermore, we have demonstrated secure information display by use of an LCD panel.

Procedures for dealing with certain types of noise and systematic errors common to many Hadamard transform optical systems

NASA Technical Reports Server (NTRS)

Harwit, M.

1977-01-01

Sources of noise and error correcting procedures characteristic of Hadamard transform optical systems were investigated. Reduction of spectral noise due to noise spikes in the data, the effect of random errors, the relative performance of Fourier and Hadamard transform spectrometers operated under identical detector-noise-limited conditions, and systematic means for dealing with mask defects are among the topics discussed. The distortion in Hadamard transform optical instruments caused by moving Masks, incorrect mask alignment, missing measurements, and diffraction is analyzed and techniques for reducing or eliminating this distortion are described.

Preference for a fixed combination of brinzolamide/timolol versus dorzolamide/timolol among patients with open-angle glaucoma or ocular hypertension.

PubMed

Sanseau, Ana; Sampaolesi, Juan; Suzuki, Emilio Rintaro; Lopes, Joao Franca; Borel, Hector

2013-01-01

To assess ocular discomfort upon instillation and patient preference for brinzolamide/timolol relative to dorzolamide/timolol, in patients with open-angle glaucoma or ocular hypertension. This was a multicenter, prospective, patient-masked, randomized, crossover study. On day 0, patients received one drop of brinzolamide/timolol in one eye and one drop of dorzolamide/timolol in the contralateral eye. On day 1, patients were randomly assigned to receive one drop of either brinzolamide/timolol or dorzolamide/timolol in both eyes; on day 2, patients received one drop of the alternate treatment in both eyes. Measures included a patient preference question on day 2 (primary) and mean ocular discomfort scale scores on days 1 and 2 (secondary). Safety assessments included adverse events, visual acuity, and slit-lamp examinations. Of 120 patients who enrolled, 115 completed the study. Of these, 112 patients instilled both medications and expressed a study medication preference on day 2. A significantly greater percentage preferred brinzolamide/timolol to dorzolamide/timolol (67.0% versus 30.4%; P < 0.001). The ocular discomfort (expressed as mean [standard deviation]) with brinzolamide/timolol was significantly lower than with dorzolamide/timolol (day 2:1.9 [2.3] versus 3.7 [2.8], respectively [P = 0.0003]; both days combined: 2.1 [2.5] versus 3.5 [2.9], respectively [P = 0.00014]). On day 1, five patients receiving brinzolamide/timolol reported five nonserious adverse events (AEs): flu (n = 1), bitter taste (n = 2), and headache (n = 2). Four events, bitter taste (two events) and headache (two events), were considered related to brinzolamide/timolol. Events were mild in intensity, except bitter taste of moderate intensity reported by one patient. No AEs were reported at day 2. All AEs resolved without additional treatment. No clinically relevant changes from baseline were observed in best-corrected visual acuity or slit-lamp examinations of ocular signs. Patients had less discomfort with brinzolamide/timolol than with dorzolamide/timolol, and more expressed a preference for brinzolamide/timolol. Both treatments were generally safe and well tolerated.

Non-invasive ventilation: evaluation of CO2 washout by intentional leaking in three recent oronasal masks. A pilot study.

PubMed

Medrinal, C; Prieur, G; Contal, O; Villiot-Danger, E; Doyle, C; Reychler, G; Quieffin, J

2015-05-01

Many types of interfaces with intentional leaks exist for Non Invasive Ventilation. The purpose of intentional leaks is to remove CO2 from the interface, however the calibration does not allow a sufficiently large flow and rebreathing of CO2 can occur. The aim of this study was to compare the CO2 rinsing capacities of three new generation oronasal masks with intentional leaks (A: Quattro®, [Resmed]; B: Amara® [Respironics]; C: Forma® [Fisher&Paykel]) in healthy subjects. Seventeen healthy volunteers were included in this prospective cross-sectional, randomized, double-blinded trial. Each subject underwent ventilation with a home ventilator (IPAP: 14 cmH2O; EPAP: 4 cmH2O) with each mask consecutively. Transcutaneous capnography (PtcCO2) recordings were carried out throughout the trial and ventilator data (tidal volume, respiratory rate, minute ventilation and unintentional leaks) were also analyzed. Mask comfort was assessed using a visual analog scale (0 to 10). The results showed no differences in PtcCO2 between masks (P=0.82). There were no significant differences in respiratory parameters (tidal volume, P=0.79; respiratory rate, P=0.65; minute ventilation, P=0.12) between masks. The rate of unintentional leaks were significantly lower for Mask A (P=0.016). Subjects rated Mask A and Mask C as more comfortable than Mask B (P=0.041). There was no effect of mask on PtcCO2 in healthy subjects. The mask with the highest comfort rating had not the lowest rate of unintentional leaks.

Efficacy and safety of intravenous secukinumab in noninfectious uveitis requiring steroid-sparing immunosuppressive therapy.

PubMed

Letko, Erik; Yeh, Steven; Foster, C Stephen; Pleyer, Uwe; Brigell, Mitchell; Grosskreutz, Cynthia L

2015-05-01

Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, exhibited promising activity in a proof-of-concept study when administered in intravenous (IV) doses to patients with active, chronic, noninfectious uveitis. This study compared the efficacy and safety of different IV and subcutaneous (SC) doses of secukinumab in patients with noninfectious uveitis. Multicenter, randomized, double-masked, dose-ranging, phase 2 clinical trial. Thirty-seven patients with active noninfectious intermediate uveitis, posterior uveitis, or panuveitis who required corticosteroid-sparing immunosuppressive therapy. Patients were randomized to secukinumab 300 mg SC every 2 weeks for 4 doses, secukinumab 10 mg/kg IV every 2 weeks for 4 doses, or secukinumab 30 mg/kg IV every 4 weeks for 2 doses. Intravenous or SC saline was administered to maintain masking. Efficacy was assessed on day 57 (2-4 weeks after last dose). Percentage of patients with treatment response, defined as (1) at least a 2-grade reduction in vitreous haze score or trace or absent vitreous haze in the study eye without an increase in corticosteroid dose and without uveitis worsening or (2) reduction in corticosteroid dosages to prespecified levels without uveitis worsening. Percentage of patients with remission, defined as anterior chamber cell and vitreous haze scores of 0 or 0.5+ in both eyes without corticosteroid therapy or uveitis worsening. Secukinumab 30 mg/kg IV and 10 mg/kg IV, compared with the 300 mg SC dose, produced higher responder rates (72.7% and 61.5% vs. 33.3%, respectively) and remission rates (27.3% and 38.5% vs. 16.7%, respectively). Statistical and clinical superiority for the 30 mg/kg IV dose compared with the 300 mg SC dose was established in a Bayesian probability model. Other measures, including time to response onset, change in visual acuity, and change in vitreous haze score, showed numeric trends favoring IV dosing. Secukinumab, administered in IV or SC formulations, appeared safe and was well tolerated. Intravenous secukinumab was effective and well tolerated in noninfectious uveitis requiring systemic corticosteroid-sparing immunosuppressive therapy. Greater activity with IV dosing suggests that patients may not receive sufficient drug with SC administration. High-dose IV secukinumab may be necessary to deliver secukinumab in therapeutic concentrations. Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

An Automatic Cloud Mask Algorithm Based on Time Series of MODIS Measurements

NASA Technical Reports Server (NTRS)

Lyapustin, Alexei; Wang, Yujie; Frey, R.

2008-01-01

Quality of aerosol retrievals and atmospheric correction depends strongly on accuracy of the cloud mask (CM) algorithm. The heritage CM algorithms developed for AVHRR and MODIS use the latest sensor measurements of spectral reflectance and brightness temperature and perform processing at the pixel level. The algorithms are threshold-based and empirically tuned. They don't explicitly address the classical problem of cloud search, wherein the baseline clear-skies scene is defined for comparison. Here, we report on a new CM algorithm which explicitly builds and maintains a reference clear-skies image of the surface (refcm) using a time series of MODIS measurements. The new algorithm, developed as part of the Multi-Angle Implementation of Atmospheric Correction (MAIAC) algorithm for MODIS, relies on fact that clear-skies images of the same surface area have a common textural pattern, defined by the surface topography, boundaries of rivers and lakes, distribution of soils and vegetation etc. This pattern changes slowly given the daily rate of global Earth observations, whereas clouds introduce high-frequency random disturbances. Under clear skies, consecutive gridded images of the same surface area have a high covariance, whereas in presence of clouds covariance is usually low. This idea is central to initialization of refcm which is used to derive cloud mask in combination with spectral and brightness temperature tests. The refcm is continuously updated with the latest clear-skies MODIS measurements, thus adapting to seasonal and rapid surface changes. The algorithm is enhanced by an internal dynamic land-water-snow classification coupled with a surface change mask. An initial comparison shows that the new algorithm offers the potential to perform better than the MODIS MOD35 cloud mask in situations where the land surface is changing rapidly, and over Earth regions covered by snow and ice.

21 CFR 343.80 - Professional labeling.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., randomized, multi-center, placebo-controlled trials of predominantly male post-MI subjects and one randomized... group on the aspirin molecule. This acetyl group is responsible for the inactivation of cyclo-oxygenase... event rate was reduced to 5 percent from the 10 percent rate in the placebo group. Chronic Stable Angina...

21 CFR 343.80 - Professional labeling.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., randomized, multi-center, placebo-controlled trials of predominantly male post-MI subjects and one randomized... group on the aspirin molecule. This acetyl group is responsible for the inactivation of cyclo-oxygenase... event rate was reduced to 5 percent from the 10 percent rate in the placebo group. Chronic Stable Angina...

21 CFR 343.80 - Professional labeling.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., randomized, multi-center, placebo-controlled trials of predominantly male post-MI subjects and one randomized... group on the aspirin molecule. This acetyl group is responsible for the inactivation of cyclo-oxygenase... event rate was reduced to 5 percent from the 10 percent rate in the placebo group. Chronic Stable Angina...

21 CFR 343.80 - Professional labeling.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., randomized, multi-center, placebo-controlled trials of predominantly male post-MI subjects and one randomized... group on the aspirin molecule. This acetyl group is responsible for the inactivation of cyclo-oxygenase... event rate was reduced to 5 percent from the 10 percent rate in the placebo group. Chronic Stable Angina...

21 CFR 343.80 - Professional labeling.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., randomized, multi-center, placebo-controlled trials of predominantly male post-MI subjects and one randomized... group on the aspirin molecule. This acetyl group is responsible for the inactivation of cyclo-oxygenase... event rate was reduced to 5 percent from the 10 percent rate in the placebo group. Chronic Stable Angina...

Social marketing-based communications to integrate and support the HEALTHY study intervention

USDA-ARS?s Scientific Manuscript database

The HEALTHY study was a randomized, controlled, multicenter, middle school-based, multifaceted intervention designed to reduce risk factors for the development of type 2 diabetes. The study randomized 42 middle schools to intervention or control, and followed students from the sixth to the eighth gr...

Computerized Training of Working Memory in Children with ADHD-A Randomized, Controlled Trial

ERIC Educational Resources Information Center

Klingberg, Torkel; Fernell, Elisabeth; Olesen, Pernille J.; Johnson, Mats; Gustafsson, Per; Dahlstrom, Kerstin; Gillberg, Christopher G.; Forssberg, Hans; Westerberg, Helena

2005-01-01

Objective: Deficits in executive functioning, including working memory (WM) deficits, have been suggested to be important in attention-deficit/hyperactivity disorder (ADHD). During 2002 to 2003, the authors conducted a multicenter, randomized, controlled, double-blind trial to investigate the effect of improving WM by computerized, systematic…

Organizational structure and communication strategies of the bypass angioplasty revascularization investigation: a multicenter clinical trial.

PubMed

Naydeck, B L; Sutton-Tyrrell, K; Burek, K; Sopko, G S

1996-06-01

Efficient communication is a challenge for the many operating components of a multicenter randomized clinical trial. Traditional management theory states that communications generally flow along a path established by a hierarchical organizational structure. A multicenter clinical trial does not fit traditional organizational models well and requires modification of traditional communication techniques. While the scientific community typically views a clinical trial as one large and cohesive enterprise, at each site the trial may actually be conducted as a small project related to the medical specialty of the investigator. Therefore overall trial management must be accomplished through collaboration rather than through direct management. In the Bypass Angioplasty Revascularization Investigation (BARI), the BARI clinical coordinating center has designed and utilized several mechanisms that facilitate effective communication and administrative control of a multicenter clinical trial. These mechanisms provide a framework of communication techniques that accommodate the specific needs of a complex organization.

Randomized Phase II Trial of Adjuvant WT-1 Analog Peptide Vaccine in Patients with Malignant Pleural Mesothelioma after Completion of Multimodality Therapy

DTIC Science & Technology

2015-09-01

multimodality therapy, but remain at exceedingly high risk for recurrence. The specific aim of this project is to conduct a multicenter, double...mskcc.org Table of Contents Page Introduction…………………………………………………………….………..….. 4 Body………………………………………………………………………………….. 4 Key Research...exceedingly high risk for recurrence. The specific aim of this project is to conduct a multicenter, double-blinded, randomized trial comparing treatment

Whether Visual Information Loss of Expression by Community Pharmacist Masks to Effect a Change in Feeling of Trust among Help-seeker?

PubMed

Kishimoto, Keiko; Hasaka, Akiko; Yamaura, Katsunori; Fukushima, Noriko

2016-01-01

Pharmacy is required to shift toward human service such as hearing the complaints of health. But the study about help-seeking behavior to pharmacist is not really investigated. We hypothesized that a decrease in expression visibility, due to pharmacists' typical masks, may negatively impact help-seeker' trust in pharmacist. The sample included 100 drugstore customers aged ≥18 years. Participants were stratified by gender and randomly assigned to two groups: evaluation of clear-masked and normal-masked pharmacists. After viewing a video with either male or female pharmacists wearing either clear or normal masks, participants completed a questionnaire. The primary outcome was trust in pharmacist measured by the Trust Scale and the secondary outcome was impression of the pharmacist measured by nineteen pairs of adjectives. There were no differences by gender on trust scores. Results revealed that both male and female pharmacists who wore clear masks were rated as more trustworthy than normal-masked pharmacists (p<0.001, d=0.903, and p=0.001, d=0.716, respectively). Sixteen of nineteen adjectives reported for pharmacists wearing normal masks indicated greater negative intention than those with clear masks (d=0.431-1.469). In most cases, among pharmacists wearing clear masks, results showed positive correlations between trust and each impression adjective (r=0.279-0.710). Our findings indicate that pharmacists wearing normal masks, which partially hide facial expressions, may decrease customer's trust in pharmacist. Further, normal masks were associated with negative impression. To avoid the inhibition of help-seek behavior, we recommend that pharmacists wear a clear mask and increase non-verbal communication.

The total face mask is more comfortable than the oronasal mask in noninvasive ventilation but is not associated with improved outcome.

PubMed

Chacur, Fernando Hauaji; Vilella Felipe, Luis Marcelo; Fernandes, Cintia Gonçalves; Lazzarini, Luiz Claudio Oliveira

2011-01-01

Noninvasive positive-pressure ventilation (NPPV) is commonly used to improve ventilation and oxygenation and avoid endotracheal intubation and mechanical ventilation. Although clinically indicated, most patients fail to use NPPV due to mask intolerance. A total face mask was designed to increase compliance, but whether this translates into better outcome (improvement in clinical and blood gas parameters and less intubation) is unknown. We compared the evolution of the clinical parameters, blood gases, levels of ventilatory support and rate of endotracheal intubation using the total face mask or the traditional oronasal mask during NPPV. A total of 60 patients were randomized to use either mask during NPPV. The clinical and laboratory parameters, as well as the level of ventilatory support were recorded at different intervals in both groups for up to 6 h. In addition, the tolerance for each mask and the need for endotracheal intubation were compared. Patients tolerated the total face mask significantly better (p = 0.0010) and used NPPV for a longer time (p = 0.0017) when compared with the oronasal mask. Just 1 patient switched to the total face mask because of intolerance. Although better tolerated, the rate of endotracheal intubation was similar in both groups (p = 0.4376), as was the clinical and laboratory evolution. The total face mask was more comfortable, allowing the patients to tolerate NPPV longer; however, these accomplishments did not translate into a better outcome. Due to its comfort, the total face mask should be available, at least as an option, in units where NPPVs are routinely applied. Copyright © 2011 S. Karger AG, Basel.

Delivery of helium–oxygen mixture during spontaneous breathing: evaluation of three high-concentration face masks.

PubMed

Roche-Campo, Ferran; Vignaux, Laurence; Galia, Fabrice; Lyazidi, Aissam; Vargas, Frédéric; Texereau, Joëlle; Apiou-Sbirlea, Gabriela; Jolliet, Philippe; Brochard, Laurent

2011-11-01

To evaluate the efficacy of delivering a mixture of helium and oxygen gas (He–O2) in spontaneous ventilation. Three high oxygen flow reservoir masks were tested: the Heliox21, specifically designed for helium; the Hi-Ox80 mask, with an inspiratory and an expiratory valve; and a standard high-concentration face mask. This prospective randomized crossover study was performed in six healthy volunteers in a laboratory setting. Volunteers breathed a mixture of 78% He/22% O2 through each of the masks under two different breathing conditions (rest and hyperventilation: minute ventilation of 14.9 ± 6.1 and 26.7 ± 8.7 L min(−1), respectively) and four different He–O2 flow rates (7, 10, 12, and 15 L min(−1)). A nasopharyngeal catheter was used to estimate He pharyngeal concentration (Fp [He]) in the airways in order to determine the percentage of contamination with room air (% air cont) at end-expiration. Under all testing conditions, the Hi-Ox80 mask presented a significantly lower % air cont. During resting breathing pattern, a Fp [He] higher than 50% was achieved in 54% of the tests performed with the Hi-Ox80 mask compared to 29% for the Heliox21 mask and only 17% for the standard mask. At hyperventilation, a Fp [He] higher than 50% was achieved in 17% of the tests performed with the Hi-Ox mask compared to 4% for the other two masks. He–O2 administration via the usual high-concentration reservoir masks results in significant dilution by room air. The Hi-Ox80 mask minimized room air contamination and much more frequently achieved a pharyngeal He concentration higher than 50%.

Oxygen therapy for cluster headache. A mask comparison trial. A single-blinded, placebo-controlled, crossover study.

PubMed

Petersen, Anja S; Barloese, Mads Cj; Lund, Nunu Lt; Jensen, Rigmor H

2017-03-01

Purpose The purpose of this article is to investigate possible differences in effect between three types of masks in the acute treatment of cluster headache (CH). Patients and methods Fifty-seven CH patients according to ICHD-II-criteria participated in a single-blinded, semi-randomized, placebo-controlled, crossover inpatient study, and 102 CH attacks were treated with 100% oxygen delivered by demand valve oxygen (DVO), O 2 ptimask or simple mask (15 liters/min) or placebo delivered by DVO for 15 minutes. Primary endpoint: Two-point decrease of pain on a five-point rating scale within 15 minutes. Results Only 10 CH patients had multiple attacks and reached the point of placebo. There were no significant differences between masks in the primary endpoints ( p = 0.412). After 15 minutes 48% had a two-point decrease using the DVO compared to 45% with placebo ( p = 0.867). After 30 minutes 68% were pain free or had pain relief using DVO and 45% by placebo ( p = 0.061). The DVO was preferred by 62% compared to 5% and 33% for simple mask ( p < 0.0001) and O 2 ptimask ( p = 0.061). In the first attack the DVO was significantly better at achieving pain relief at 15 minutes ( p = 0.018). Treatment with DVO or O 2 ptimask reduced the need for rescue medication compared to the simple mask (23%, 19%, 50%, respectively). No treatment-related adverse events were observed. Conclusion The primary endpoint with pain relief at 15 minutes was non-significant; however, a post hoc analysis of the first attack significantly favored DVO. Further, therapy by O 2 ptimask and DVO resulted in a decreased need for rescue medication. We recommend that CH patients be offered DVO or O 2 ptimask before oxygen therapy is abandoned.

The Efficacy and Safety of Chinese Herbal Medicine Jinlida as Add-On Medication in Type 2 Diabetes Patients Ineffectively Managed by Metformin Monotherapy: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial

PubMed Central

Lian, Fengmei; Tian, Jiaxing; Chen, Xinyan; Li, Zhibin; Piao, Chunli; Guo, Junjie; Ma, Licheng; Zhao, Lijuan; Xia, Chengdong; Wang, Chong-Zhi; Yuan, Chun-Su; Tong, Xiaolin

2015-01-01

Background Metformin plays an important role in diabetes treatment. Studies have shown that the combined use of oral hypoglycemic medications is more effective than metformin monotherapy. In this double-blind, randomized, placebo-controlled, multicenter trial, we evaluated whether Jinlida, a Chinese herbal medicine, enhances the glycemic control of metformin in type 2 diabetes patients whose HbA1c was ineffectively controlled with metformin alone. Methods A total of 186 diabetes patients were enrolled in this double-Blind, randomized, placebo-controlled, multicenter trial. Subjects were randomly allocated to receive either Jinlida (9 g) or the placebo TID for 12 consecutive weeks. All subjects in both groups also continuously received their metformin without any dose change. During this 12-week period, the HbA1c, FPG, 2h PG, body weight, BMI were assessed. HOMA insulin resistance (HOMA-IR) and β-cell function (HOMA- β) were also evaluated. Results At week 12, compared to the HbA1c level from week 0, the level of the Jinlida group was reduced by 0.92 ± 1.09% and that of the placebo group was reduced by 0.53 ± 0.94%. The 95% CI was 0.69 - 1.14 for the Jinlida group vs. 0.34 - 0.72 for the placebo group. There was a very significant HbA1c reduction between the two groups after 12 weeks (p < 0.01). Both FG and 2h PG levels of the Jinlida group and placebo group were reduced from week 0. There were a very significant FG and 2h PG level reductions between the two groups after 12 weeks (both p < 0.01). The Jinlida group also showed improved β-cell function with a HOMA-β increase (p < 0.05). No statistical significance was observed in the body weight and BMI changes. No serious adverse events were reported. Conclusion Jinlida significantly enhanced the hypoglycemic action of metformin when the drug was used alone. This Chinese herbal medicine may have a clinical value as an add-on medication to metformin monotherapy. Trial Registration Chinese Clinical Trial Register ChiCTR-TRC-13003159 PMID:26098833

The Efficacy and Safety of Chinese Herbal Medicine Jinlida as Add-On Medication in Type 2 Diabetes Patients Ineffectively Managed by Metformin Monotherapy: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial.

PubMed

Lian, Fengmei; Tian, Jiaxing; Chen, Xinyan; Li, Zhibin; Piao, Chunli; Guo, Junjie; Ma, Licheng; Zhao, Lijuan; Xia, Chengdong; Wang, Chong-Zhi; Yuan, Chun-Su; Tong, Xiaolin

2015-01-01

Metformin plays an important role in diabetes treatment. Studies have shown that the combined use of oral hypoglycemic medications is more effective than metformin monotherapy. In this double-blind, randomized, placebo-controlled, multicenter trial, we evaluated whether Jinlida, a Chinese herbal medicine, enhances the glycemic control of metformin in type 2 diabetes patients whose HbA1c was ineffectively controlled with metformin alone. A total of 186 diabetes patients were enrolled in this double-Blind, randomized, placebo-controlled, multicenter trial. Subjects were randomly allocated to receive either Jinlida (9 g) or the placebo TID for 12 consecutive weeks. All subjects in both groups also continuously received their metformin without any dose change. During this 12-week period, the HbA1c, FPG, 2 h PG, body weight, BMI were assessed. HOMA insulin resistance (HOMA-IR) and β-cell function (HOMA-β) were also evaluated. At week 12, compared to the HbA1c level from week 0, the level of the Jinlida group was reduced by 0.92 ± 1.09% and that of the placebo group was reduced by 0.53 ± 0.94%. The 95% CI was 0.69-1.14 for the Jinlida group vs. 0.34-0.72 for the placebo group. There was a very significant HbA1c reduction between the two groups after 12 weeks (p < 0.01). Both FG and 2 h PG levels of the Jinlida group and placebo group were reduced from week 0. There were a very significant FG and 2 h PG level reductions between the two groups after 12 weeks (both p < 0.01). The Jinlida group also showed improved β-cell function with a HOMA-β increase (p < 0.05). No statistical significance was observed in the body weight and BMI changes. No serious adverse events were reported. Jinlida significantly enhanced the hypoglycemic action of metformin when the drug was used alone. This Chinese herbal medicine may have a clinical value as an add-on medication to metformin monotherapy. Chinese Clinical Trial Register ChiCTR-TRC-13003159.

Ensuring Confidentiality of Geocoded Health Data: Assessing Geographic Masking Strategies for Individual-Level Data

PubMed Central

Zandbergen, Paul A.

2014-01-01

Public health datasets increasingly use geographic identifiers such as an individual's address. Geocoding these addresses often provides new insights since it becomes possible to examine spatial patterns and associations. Address information is typically considered confidential and is therefore not released or shared with others. Publishing maps with the locations of individuals, however, may also breach confidentiality since addresses and associated identities can be discovered through reverse geocoding. One commonly used technique to protect confidentiality when releasing individual-level geocoded data is geographic masking. This typically consists of applying a certain amount of random perturbation in a systematic manner to reduce the risk of reidentification. A number of geographic masking techniques have been developed as well as methods to quantity the risk of reidentification associated with a particular masking method. This paper presents a review of the current state-of-the-art in geographic masking, summarizing the various methods and their strengths and weaknesses. Despite recent progress, no universally accepted or endorsed geographic masking technique has emerged. Researchers on the other hand are publishing maps using geographic masking of confidential locations. Any researcher publishing such maps is advised to become familiar with the different masking techniques available and their associated reidentification risks. PMID:26556417

A Short-Term, Multicenter, Placebo-Controlled, Randomized Withdrawal Study of a Metabotropic Glutamate 2/3 Receptor Agonist Using an Electronic Patient-Reported Outcome Device in Patients With Schizophrenia

PubMed Central

Stauffer, Virginia L.; Baygani, Simin K.; Kinon, Bruce J.; Krikke-Workel, Judith O.

2014-01-01

Abstract This 6-week, multicenter, randomized withdrawal, placebo-controlled trial sought to determine whether symptoms of physical dependence occur after abrupt cessation of pomaglumetad methionil (LY2140023 monohydrate), a metabotropic glutamate 2/3 receptor agonist, in patients with schizophrenia. Eligible outpatients, 18 to 65 years old who required a modification or initiation of antipsychotic medication received 4 weeks of pomaglumetad methionil during open-label treatment and then were randomized, double-blind, to continue pomaglumetad methionil or receive placebo for 2 weeks. The primary outcome compared results of the 3-day moving mean of the total score on the Discontinuation Symptom Checklist-Modified Rickels for pomaglumetad methionil-treated patients with those on placebo during the randomized withdrawal phase. An electronic patient-reported outcome (ePRO) device was used daily to record these results. During the withdrawal phase, 103 patients were randomized, and 98 patients completed the trial. There was no statistically significant evidence of withdrawal symptoms associated with placebo compared with pomaglumetad methionil continuation as measured by Discontinuation Symptom Checklist-Modified Rickels (P = 0.170). The results are supported by secondary analyses with the clinician-rated, Clinical Institute Withdrawal Assessment of Alcohol Scale Revised, which showed no statistically significant differences between treatment groups. Using the ePRO device, 82.5% of the patients achieved 75% to 100% of compliance. No discontinuations due to worsening of schizophrenia, serious adverse events, deaths, or seizures were reported during either phase of the study. These findings suggest that there is no evidence of withdrawal symptoms associated with the abrupt discontinuation of pomaglumetad methionil and that an ePRO device can be successfully used in a multicenter schizophrenia trial. PMID:25006819

Particulate face masks for protection against airborne pathogens - one size does not fit all: an observational study.

PubMed

Winter, Susan; Thomas, Jane H; Stephens, Dianne P; Davis, Joshua S

2010-03-01

To determine the proportion of hospital staff who pass fit tests with each of three commonly used particulate face masks, and factors influencing preference and fit test results. Observational study. 50 healthy hospital staff volunteers in an 18-bed general intensive care unit in an Australian teaching hospital. Participants were administered a questionnaire about mask use and their preferred mask and underwent qualitative fit-testing with each of three different particulate masks: Kimberly-Clark Tecnol FluidShield N95 particulate filter respirator (KC), 3M Flat Fold 9320 particulate respirator and 3M 8822 particulate respirator with exhalation valve. Participants who failed fittesting were trained in correct mask donning, and fittesting was repeated. Proportion of participants who passed the fit test for each mask and the effect of training. The proportion of participants who passed a fit test was low for all three masks tested (KC, 16%; flat fold, 28%; and valved, 34%). Rates improved after training: the first mask tested fitted in 18% of participants pre-training and 40% post-training (P = 0.02). None of the masks fitted for 28% of participants. There were no significant predictors of fit-test results. A large proportion of individuals failed a fit test with any given mask, and we were not able to identify any factors that predicted mask fit in individuals. Training on mask use improved the rates of adequate fit. Hospitals should carry a range of P2 masks, and should conduct systematic P2 mask training and fit-testing programs for all staff potentially exposed to airborne pathogens.

Effectiveness of Placebo Therapy for Maintaining Masking in a Clinical Trial of Vergence/Accommodative Therapy

PubMed Central

Kulp, Marjean; Mitchell, G. Lynn; Borsting, Eric; Scheiman, Mitchell; Cotter, Susan; Rouse, Michael; Tamkins, Susanna; Mohney, Brian G.; Toole, Andrew; Reuter, Kathleen

2009-01-01

Purpose To evaluate the effectiveness of the Convergence Insufficiency Treatment Trial (CITT) placebo therapy program in maintaining masking of patients randomized to the office-based treatment arms, determine whether demographic variables affect masking, and determine whether perception of assigned treatment group was associated with treatment outcome or adherence to treatment. Methods Patients (n = 221, ages, 9–17 years) were randomized to one of four treatment groups, two of which were office-based and masked to treatment (n = 114). The placebo therapy program was designed to appear to be real vergence/accommodative therapy, without stimulating vergence, accommodation, or fine saccades (beyond levels of daily visual activities). After treatment, patients in the office-based groups were asked whether they thought they had received real or placebo therapy and how confident they were in their answers. Results Ninety-three percent of patients assigned to real therapy and 85% assigned to placebo therapy thought they were in the real therapy group (P = 0.17). No significant differences were found between the two groups in adherence to the therapy (P ≥ 0.22 for all comparisons). The percentage of patients who thought they were assigned to real therapy did not differ by age, sex, race, or ethnicity (P > 0.30 for all comparisons). No association was found between patients' perception of group assignment and symptoms or signs at outcome (P ≥ 0.38 for all comparisons). Conclusions The CITT placebo therapy program was effective in maintaining patient masking in this study and therefore may have potential for use in future clinical trials using vergence/accommodative therapy. Masking was not affected by demographic variables. Perception of group assignment was not related to symptoms or signs at outcome (ClinicalTrials.gov number, NCT00338611). PMID:19151384

Shadows alter facial expressions of Noh masks.

PubMed

Kawai, Nobuyuki; Miyata, Hiromitsu; Nishimura, Ritsuko; Okanoya, Kazuo

2013-01-01

A Noh mask, worn by expert actors during performance on the Japanese traditional Noh drama, conveys various emotional expressions despite its fixed physical properties. How does the mask change its expressions? Shadows change subtly during the actual Noh drama, which plays a key role in creating elusive artistic enchantment. We here describe evidence from two experiments regarding how attached shadows of the Noh masks influence the observers' recognition of the emotional expressions. In Experiment 1, neutral-faced Noh masks having the attached shadows of the happy/sad masks were recognized as bearing happy/sad expressions, respectively. This was true for all four types of masks each of which represented a character differing in sex and age, even though the original characteristics of the masks also greatly influenced the evaluation of emotions. Experiment 2 further revealed that frontal Noh mask images having shadows of upward/downward tilted masks were evaluated as sad/happy, respectively. This was consistent with outcomes from preceding studies using actually tilted Noh mask images. Results from the two experiments concur that purely manipulating attached shadows of the different types of Noh masks significantly alters the emotion recognition. These findings go in line with the mysterious facial expressions observed in Western paintings, such as the elusive qualities of Mona Lisa's smile. They also agree with the aesthetic principle of Japanese traditional art "yugen (profound grace and subtlety)", which highly appreciates subtle emotional expressions in the darkness.

Oronasal Masks Require a Higher Pressure than Nasal and Nasal Pillow Masks for the Treatment of Obstructive Sleep Apnea

PubMed Central

Deshpande, Sheetal; Joosten, Simon; Turton, Anthony; Edwards, Bradley A.; Landry, Shane; Mansfield, Darren R.; Hamilton, Garun S.

2016-01-01

Study Objectives: Oronasal masks are frequently used for continuous positive airway pressure (CPAP) treatment in patients with obstructive sleep apnea (OSA). The aim of this study was to (1) determine if CPAP requirements are higher for oronasal masks compared to nasal mask interfaces and (2) assess whether polysomnography and patient characteristics differed among mask preference groups. Methods: Retrospective analysis of all CPAP implementation polysomnograms between July 2013 and June 2014. Prescribed CPAP level, polysomnography results and patient data were compared according to mask type (n = 358). Results: Oronasal masks were used in 46%, nasal masks in 35% and nasal pillow masks in 19%. There was no difference according to mask type for baseline apnea-hypopnea index (AHI), body mass index (BMI), waist or neck circumference. CPAP level was higher for oronasal masks, 12 (10–15.5) cm H2O compared to nasal pillow masks, 11 (8–12.5) cm H2O and nasal masks, 10 (8–12) cm H2O, p < 0.0001 (Median [interquartile range]). Oronasal mask type, AHI, age, and BMI were independent predictors of a higher CPAP pressure (p < 0.0005, adjusted R2 = 0.26.). For patients with CPAP ≥ 15 cm H2O, there was an odds ratio of 4.5 (95% CI 2.5–8.0) for having an oronasal compared to a nasal or nasal pillow mask. Residual median AHI was higher for oronasal masks (11.3 events/h) than for nasal masks (6.4 events/h) and nasal pillows (6.7 events/h), p < 0.001. Conclusions: Compared to nasal mask types, oronasal masks are associated with higher CPAP pressures (particularly pressures ≥ 15 cm H2O) and a higher residual AHI. Further evaluation with a randomized control trial is required to definitively establish the effect of mask type on pressure requirements. Commentary: A commentary on this article appears in this issue on page 1209. Citation: Deshpande S, Joosten S, Turton A, Edwards BA, Landry S, Mansfield DR, Hamilton GS. Oronasal masks require a higher pressure than nasal and nasal pillow masks for the treatment of obstructive sleep apnea. J Clin Sleep Med 2016;12(9):1263–1268. PMID:27448430

Twelve-week, multicenter, placebo-controlled, randomized, double-blind, parallel-group, comparative phase II/III study of benzoyl peroxide gel in patients with acne vulgaris: A secondary publication.

PubMed

Kawashima, Makoto; Sato, Shinichi; Furukawa, Fukumi; Matsunaga, Kayoko; Akamatsu, Hirohiko; Igarashi, Atsuyuki; Tsunemi, Yuichiro; Hayashi, Nobukazu; Yamamoto, Yuki; Nagare, Toshitaka; Katsuramaki, Tsuneo

2017-07-01

A placebo-controlled, randomized, double-blind, parallel-group, comparative, multicenter study was conducted to investigate the efficacy and safety of benzoyl peroxide (BPO) gel, administrated once daily for 12 weeks to Japanese patients with acne vulgaris. Efficacy was evaluated by counting all inflammatory and non-inflammatory lesions. Safety was evaluated based on adverse events, local skin tolerability scores and laboratory test values. All 609 subjects were randomly assigned to receive the study products (2.5% and 5% BPO and placebo), and 607 subjects were included in the full analysis set, 544 in the per protocol set and 609 in the safety analyses. The median rates of reduction from baseline to the last evaluation of the inflammatory lesion counts, the primary end-point, in the 2.5% and 5% BPO groups were 72.7% and 75.0%, respectively, and were significantly higher than that in the placebo group (41.7%). No deaths or other serious adverse events were observed. The incidences of adverse events in the 2.5% and 5% BPO groups were 56.4% and 58.8%, respectively; a higher incidence than in the placebo group, but there was no obvious difference between the 2.5% and 5% BPO groups. All adverse events were mild or moderate in severity. Most adverse events did not lead to study product discontinuation. The results suggested that both 2.5% and 5% BPO are useful for the treatment of acne vulgaris. © 2017 The Authors. The Journal of Dermatology published by John Wiley & Sons Australia, Ltd.

An Intelligent Fingerprint-Biometric Image Scrambling Scheme

NASA Astrophysics Data System (ADS)

Khan, Muhammad Khurram; Zhang, Jiashu

To obstruct the attacks, and to hamper with the liveness and retransmission issues of biometrics images, we have researched on the challenge/response-based biometrics scrambled image transmission. We proposed an intelligent biometrics sensor, which has computational power to receive challenges from the authentication server and generate response against the challenge with the encrypted biometric image. We utilized the FRT for biometric image encryption and used its scaling factors and random phase mask as the additional secret keys. In addition, we chaotically generated the random phase masks by a chaotic map to further improve the encryption security. Experimental and simulation results have shown that the presented system is secure, robust, and deters the risks of attacks of biometrics image transmission.

Coherent diffractive imaging using randomly coded masks

DOE PAGES

Seaberg, Matthew H.; d'Aspremont, Alexandre; Turner, Joshua J.

2015-12-07

We experimentally demonstrate an extension to coherent diffractive imaging that encodes additional information through the use of a series of randomly coded masks, removing the need for typical object-domain constraints while guaranteeing a unique solution to the phase retrieval problem. Phase retrieval is performed using a numerical convex relaxation routine known as “PhaseCut,” an iterative algorithm known for its stability and for its ability to find the global solution, which can be found efficiently and which is robust to noise. As a result, the experiment is performed using a laser diode at 532.2 nm, enabling rapid prototyping for future X-raymore » synchrotron and even free electron laser experiments.« less

Coherent diffractive imaging using randomly coded masks

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

Seaberg, Matthew H., E-mail: seaberg@slac.stanford.edu; Linac Coherent Light Source, SLAC National Accelerator Laboratory, 2575 Sand Hill Road, Menlo Park, California 94025; D'Aspremont, Alexandre

2015-12-07

We experimentally demonstrate an extension to coherent diffractive imaging that encodes additional information through the use of a series of randomly coded masks, removing the need for typical object-domain constraints while guaranteeing a unique solution to the phase retrieval problem. Phase retrieval is performed using a numerical convex relaxation routine known as “PhaseCut,” an iterative algorithm known for its stability and for its ability to find the global solution, which can be found efficiently and which is robust to noise. The experiment is performed using a laser diode at 532.2 nm, enabling rapid prototyping for future X-ray synchrotron and even freemore » electron laser experiments.« less

Cervical pessary to prevent preterm birth in women with twin gestation and sonographic short cervix: a multicenter randomized controlled trial (PECEP-Twins).

PubMed

Goya, Maria; de la Calle, Maria; Pratcorona, Laia; Merced, Carme; Rodó, Carlota; Muñoz, Begoña; Juan, Miquel; Serrano, Ariana; Llurba, Elisa; Higueras, Teresa; Carreras, Elena; Cabero, Luis

2016-02-01

Spontaneous preterm birth (SPB) is the leading cause of perinatal morbidity and mortality. In twins, the rate of preterm birth is higher than in singletons; interventions to prevent preterm birth are needed in this high-risk population. We sought to test whether a cervical pessary reduces the preterm birth rate in twin pregnancies with sonographic short cervix. A prospective, open-label, multicenter, randomized clinical trial was conducted in 5 hospitals in Spain. The ethics committees of all participating hospitals approved the protocol. The trial was registered as ClinicalTrials.gov, number NCT01242410. Eligible women were scanned in Spain. The primary outcome was SPB <34 weeks of gestation. Neonatal morbidity and mortality were also evaluated. Cervical length was measured in 2287 women; 137 pregnant women with a sonographic cervical length ≤25 mm (of 154 detected with a short cervix) were randomly assigned to receive a cervical pessary or expectant management (1:1 ratio). SPB <34 weeks of gestation was significantly less frequent in the pessary group than in the expectant management group (11/68 [16.2%] vs 26/66 [39.4%]; relative risk, 0.41; 95% confidence interval, 0.22-0.76). Pessary use was associated with a significant reduction in the rate of birthweight <2500 g (P = .01). No significant differences were observed in composite neonatal morbidity outcome (8/136 [5.9%] vs 12/130 [9.1%]; relative risk, 0.64; 95% confidence interval, 0.27-1.50) or neonatal mortality (none) between the groups. No serious adverse effects associated with the use of a cervical pessary were observed. The insertion of a cervical pessary was associated with a significant reduction in the SPB rate. We propose the use of a cervical pessary for preventing preterm birth in twin pregnancies of mothers with a short cervix. Copyright © 2016 Elsevier Inc. All rights reserved.

Closed-Loop Control Better than Open-Loop Control of Profofol TCI Guided by BIS: A Randomized, Controlled, Multicenter Clinical Trial to Evaluate the CONCERT-CL Closed-Loop System

PubMed Central

Zhang, Xuena; Wu, Anshi; Yao, Shanglong; Xue, Zhanggang; Yue, Yun

2015-01-01

Background The CONCERT-CL closed-loop infusion system designed by VERYARK Technology Co., Ltd. (Guangxi, China) is an innovation using TCI combined with closed-loop controlled intravenous anesthesia under the guide of BIS. In this study we performed a randomized, controlled, multicenter study to compare closed-loop control and open-loop control of propofol by using the CONCERT-CL closed-loop infusion system. Methods 180 surgical patients from three medical centers undergone TCI intravenous anesthesia with propofol and remifentanil were randomly assigned to propofol closed-loop group and propofol opened-loop groups. Primary outcome was global score (GS, GS = (MDAPE+Wobble)/% of time of bispectral index (BIS) 40-60). Secondary outcomes were doses of the anesthetics and emergence time from anesthesia, such as, time to tracheal extubation. Results There were 89 and 86 patients in the closed-loop and opened-loop groups, respectively. GS in the closed-loop groups (22.21±8.50) were lower than that in the opened-loop group (27.19±15.26) (p=0.009). The higher proportion of time of BIS between 40 and 60 was also observed in the closed-loop group (84.11±9.50%), while that was 79.92±13.17% in the opened-loop group, (p=0.016). No significant differences in propofol dose and time of tracheal extubation were observed. The frequency of propofol regulation in the closed-loop group (31.55±9.46 times/hr) was obverse higher than that in the opened-loop group (6.84±6.21 times/hr) (p=0.000). Conclusion The CONCERT-CL closed-loop infusion system can automatically regulate the TCI of propofol, maintain the BIS value in an adequate range and reduce the workload of anesthesiologists better than open-loop system. Trial Registration ChiCTR ChiCTR-OOR-14005551 PMID:25886041

Cryptosystem for Securing Image Encryption Using Structured Phase Masks in Fresnel Wavelet Transform Domain

NASA Astrophysics Data System (ADS)

Singh, Hukum

2016-12-01

A cryptosystem for securing image encryption is considered by using double random phase encoding in Fresnel wavelet transform (FWT) domain. Random phase masks (RPMs) and structured phase masks (SPMs) based on devil's vortex toroidal lens (DVTL) are used in spatial as well as in Fourier planes. The images to be encrypted are first Fresnel transformed and then single-level discrete wavelet transform (DWT) is apply to decompose LL,HL, LH and HH matrices. The resulting matrices from the DWT are multiplied by additional RPMs and the resultants are subjected to inverse DWT for the encrypted images. The scheme is more secure because of many parameters used in the construction of SPM. The original images are recovered by using the correct parameters of FWT and SPM. Phase mask SPM based on DVTL increases security that enlarges the key space for encryption and decryption. The proposed encryption scheme is a lens-less optical system and its digital implementation has been performed using MATLAB 7.6.0 (R2008a). The computed value of mean-squared-error between the retrieved and the input images shows the efficacy of scheme. The sensitivity to encryption parameters, robustness against occlusion, entropy and multiplicative Gaussian noise attacks have been analysed.

Information on center characteristics as costs' determinants in multicenter clinical trials: is modeling center effect worth the effort?

PubMed

Petrinco, Michele; Pagano, Eva; Desideri, Alessandro; Bigi, Riccardo; Ghidina, Marco; Ferrando, Alberto; Cortigiani, Lauro; Merletti, Franco; Gregori, Dario

2009-01-01

Several methodological problems arise when health outcomes and resource utilization are collected at different sites. To avoid misleading conclusions in multi-center economic evaluations the center effect needs to be taken into adequate consideration. The aim of this article is to compare several models, which make use of a different amount of information about the enrolling center. To model the association of total medical costs with the levels of two sets of covariates, one at patient and one at center level, we considered four statistical models, based on the Gamma model in the class of the Generalized Linear Models with a log link, which use different amount of information on the enrolling centers. Models were applied to Cost of Strategies after Myocardial Infarction data, an international randomized trial on costs of uncomplicated acute myocardial infarction (AMI). The simple center effect adjustment based on a single random effect results in a more conservative estimation of the parameters as compared with approaches which make use of deeper information on the centers characteristics. This study shows, with reference to a real multicenter trial, that center information cannot be neglected and should be collected and inserted in the analysis, better in combination with one or more random effect, taking into account in this way also the heterogeneity among centers because of unobserved centers characteristics.

Effect of structured physical activity on prevention of serious fall injuries in adults aged 70-89: randomized clinical trial (LIFE Study)

USDA-ARS?s Scientific Manuscript database

OBJECTIVE: To test whether a long term, structured physical activity program compared with a health education program reduces the risk of serious fall injuries among sedentary older people with functional limitations. DESIGN: Multicenter, single blinded randomized trial (Lifestyle Interventions and ...

Enhancing HIV Communication between Parents and Children: Efficacy of the Parents Matter! Program

ERIC Educational Resources Information Center

Miller, Kim S.; Lin, Carol Y.; Poulsen, Melissa N.; Fasula, Amy; Wyckoff, Sarah C.; Forehand, Rex; Long, Nicholas; Armistead, Lisa

2011-01-01

We examine efficacy of the Parents Matter! Program (PMP), a program to teach African-American parents of preadolescents sexual communication and HIV-prevention skills, through a multicenter, randomized control trial. A total of 1115 parent-child participants were randomized to one of three intervention arms (enhanced, brief, control). Percentages…

Stable Atlas-based Mapped Prior (STAMP) machine-learning segmentation for multicenter large-scale MRI data.

PubMed

Kim, Eun Young; Magnotta, Vincent A; Liu, Dawei; Johnson, Hans J

2014-09-01

Machine learning (ML)-based segmentation methods are a common technique in the medical image processing field. In spite of numerous research groups that have investigated ML-based segmentation frameworks, there remains unanswered aspects of performance variability for the choice of two key components: ML algorithm and intensity normalization. This investigation reveals that the choice of those elements plays a major part in determining segmentation accuracy and generalizability. The approach we have used in this study aims to evaluate relative benefits of the two elements within a subcortical MRI segmentation framework. Experiments were conducted to contrast eight machine-learning algorithm configurations and 11 normalization strategies for our brain MR segmentation framework. For the intensity normalization, a Stable Atlas-based Mapped Prior (STAMP) was utilized to take better account of contrast along boundaries of structures. Comparing eight machine learning algorithms on down-sampled segmentation MR data, it was obvious that a significant improvement was obtained using ensemble-based ML algorithms (i.e., random forest) or ANN algorithms. Further investigation between these two algorithms also revealed that the random forest results provided exceptionally good agreement with manual delineations by experts. Additional experiments showed that the effect of STAMP-based intensity normalization also improved the robustness of segmentation for multicenter data sets. The constructed framework obtained good multicenter reliability and was successfully applied on a large multicenter MR data set (n>3000). Less than 10% of automated segmentations were recommended for minimal expert intervention. These results demonstrate the feasibility of using the ML-based segmentation tools for processing large amount of multicenter MR images. We demonstrated dramatically different result profiles in segmentation accuracy according to the choice of ML algorithm and intensity normalization chosen. Copyright © 2014 Elsevier Inc. All rights reserved.

Spine device clinical trials: design and sponsorship.

PubMed

Cher, Daniel J; Capobianco, Robyn A

2015-05-01

Multicenter prospective randomized clinical trials represent the best evidence to support the safety and effectiveness of medical devices. Industry sponsorship of multicenter clinical trials is purported to lead to bias. To determine what proportion of spine device-related trials are industry-sponsored and the effect of industry sponsorship on trial design. Analysis of data from a publicly available clinical trials database. Clinical trials of spine devices registered on ClinicalTrials.gov, a publicly accessible trial database, were evaluated in terms of design, number and location of study centers, and sample size. The relationship between trial design characteristics and study sponsorship was evaluated using logistic regression and general linear models. One thousand six hundred thrity-eight studies were retrieved from ClinicalTrials.gov using the search term "spine." Of the 367 trials that focused on spine surgery, 200 (54.5%) specifically studied devices for spine surgery and 167 (45.5%) focused on other issues related to spine surgery. Compared with nondevice trials, device trials were far more likely to be sponsored by the industry (74% vs. 22.2%, odds ratio (OR) 9.9 [95% confidence interval 6.1-16.3]). Industry-sponsored device trials were more likely multicenter (80% vs. 29%, OR 9.8 [4.8-21.1]) and had approximately four times as many participating study centers (p<.0001) and larger sample sizes. There were very few US-based multicenter randomized trials of spine devices not sponsored by the industry. Most device-related spine research is industry-sponsored. Multicenter trials are more likely to be industry-sponsored. These findings suggest that previously published studies showing larger effect sizes in industry-sponsored vs. nonindustry-sponsored studies may be biased as a result of failure to take into account the marked differences in design and purpose. Copyright © 2015 Elsevier Inc. All rights reserved.

Effects of a novel method for enteral nutrition infusion involving a viscosity-regulating pectin solution: A multicenter randomized controlled trial.

PubMed

Tabei, Isao; Tsuchida, Shigeru; Akashi, Tetsuro; Ookubo, Katsuichiro; Hosoda, Satoru; Furukawa, Yoshiyuki; Tanabe, Yoshiaki; Tamura, Yoshiko

2018-02-01

The initial complications associated with infusion of enteral nutrition (EN) for clinical and nutritional care are vomiting, aspiration pneumonia, and diarrhea. There are many recommendations to prevent these complications. A novel method involving a viscosity-regulating pectin solution has been demonstrated. In Japan, this method along with the other so-called "semi-solid EN" approaches has been widely used in practice. However, there has been no randomized clinical trial to prove the efficiency and safety of a viscosity-regulating pectin solution in EN management. Therefore, we planned and initiated a multicenter randomized controlled trial to determine the efficiency and safety. This study included 34 patients from 7 medical institutions who participated. Institutional review board (IRB) approval was obtained from all participating institutions. Patients who required EN management were enrolled and randomly assigned to the viscosity regulation of enteral feeding (VREF) group and control group. The VREF group (n = 15) was managed with the addition of a viscosity-regulating pectin solution. The control group (n = 12) was managed with conventional EN administration, usually in a gradual step-up method. Daily clinical symptoms of pneumonia, fever, vomiting, and diarrhea; defecation frequency; and stool form were observed in the 2 week trial period. The dose of EN and duration of infusion were also examined. A favorable trend for clinical symptoms was noticed in the VREF group. No significant differences were observed in episodes of pneumonia, fever, vomiting, and diarrhea between the 2 groups. An apparent reduction in infusion duration and hardening of stool form were noted in the VREF group. The novel method involving a viscosity-regulating pectin solution with EN administration can be clinically performed safely and efficiently, similar to the conventional method. Moreover, there were benefits, such as improvement in stool form, a short time for EN infusion, and a reduction in vomiting episodes, with the use of the novel method. This indicates some potential advantages in the quality of life among patients receiving this novel method. Copyright © 2017 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.

Multicenter Randomized Trial of Robot-Assisted Rehabilitation for Chronic Stroke: Methods and Entry Characteristics for VA ROBOTICS

PubMed Central

Lo, Albert C.; Guarino, Peter; Krebs, Hermano I.; Volpe, Bruce T.; Bever, Christopher T.; Duncan, Pamela W.; Ringer, Robert J.; Wagner, Todd H.; Richards, Lorie G.; Bravata, Dawn M.; Haselkorn, Jodie K.; Wittenberg, George F.; Federman, Daniel G.; Corn, Barbara H.; Maffucci, Alysia D.; Peduzzi, Peter

2017-01-01

Background Chronic upper extremity impairment due to stroke has significant medical, psychosocial, and financial consequences, but few studies have examined the effectiveness of rehabilitation therapy during the chronic stroke period. Objective To test the safety and efficacy of the MIT-Manus robotic device for chronic upper extremity impairment following stroke. Methods The VA Cooperative Studies Program initiated a multicenter, randomized, controlled trial in November 2006 (VA ROBOTICS). Participants with upper extremity impairment ≥6 months poststroke were randomized to robot-assisted therapy (RT), intensive comparison therapy (ICT), or usual care (UC). RT and ICT consisted of three 1-hour treatment sessions per week for 12 weeks. The primary outcome was change in the Fugl-Meyer Assessment upper extremity motor function score at 12 weeks relative to baseline. Secondary outcomes included the Wolf Motor Function Test and the Stroke Impact Scale. Results A total of 127 participants were randomized: 49 to RT, 50 to ICT, and 28 to UC. The majority of participants were male (96%), with a mean age of 65 years. The primary stroke type was ischemic (85%), and 58% of strokes occurred in the anterior circulation. Twenty percent of the participants reported a stroke in addition to their index stroke. The average time from the index stroke to enrollment was 56 months (range, 6 months to 24 years). The mean Fugl-Meyer score at entry was 18.9. Conclusions VA ROBOTICS demonstrates the feasibility of conducting multicenter clinical trials to rigorously test new rehabilitative devices before their introduction to clinical practice. The results are expected in early 2010. PMID:19541917

Comparison of 3 biodegradable polymer and durable polymer-based drug-eluting stents in all-comers (BIO-RESORT): rationale and study design of the randomized TWENTE III multicenter trial.

PubMed

Lam, Ming Kai; Sen, Hanim; Tandjung, Kenneth; van Houwelingen, K Gert; de Vries, Arie G; Danse, Peter W; Schotborgh, Carl E; Scholte, Martijn; Löwik, Marije M; Linssen, Gerard C M; Ijzerman, Maarten J; van der Palen, Job; Doggen, Carine J M; von Birgelen, Clemens

2014-04-01

To evaluate the safety and efficacy of 2 novel drug-eluting stents (DES) with biodegradable polymer-based coatings versus a durable coating DES. BIO-RESORT is an investigator-initiated, prospective, patient-blinded, randomized multicenter trial in 3540 Dutch all-comers with various clinical syndromes, requiring percutaneous coronary interventions (PCI) with DES implantation. Randomization (stratified for diabetes mellitus) is being performed in a 1:1:1 ratio between ORSIRO sirolimus-eluting stent with circumferential biodegradable coating, SYNERGY everolimus-eluting stent with abluminal biodegradable coating, and RESOLUTE INTEGRITY zotarolimus-eluting stent with durable coating. The primary endpoint is the incidence of the composite endpoint target vessel failure at 1 year, consisting of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. Power calculation assumes a target vessel failure rate of 8.5% with a 3.5% non-inferiority margin, giving the study a power of 85% (α level .025 adjusted for multiple testing). The impact of diabetes mellitus on post-PCI outcome will be evaluated. The first patient was enrolled on December 21, 2012. BIO-RESORT is a large, prospective, randomized, multicenter trial with three arms, comparing two DES with biodegradable coatings versus a reference DES with a durable coating in 3540 all-comers. The trial will provide novel insights into the clinical outcome of modern DES and will address the impact of known and so far undetected diabetes mellitus on post-PCI outcome. Copyright © 2014 The Authors. Published by Mosby, Inc. All rights reserved.

Clinical impact of 8 prospective, randomized, multicenter glaucoma trials.

PubMed

Panarelli, Joseph F; Banitt, Michael R; Sidoti, Paul A; Budenz, Donald L; Singh, Kuldev

2015-01-01

To determine the impact of 8 multicenter randomized clinical trials (RCTs) on glaucoma practice. An electronic survey was distributed to the members of the American Glaucoma Society (AGS). Each participant was asked 2 study-specific questions and 1 standard question common to all 8 RCTs assessing the study's impact on clinical practice. RCTs included in the survey were the Advanced Glaucoma Intervention Study (AGIS), Collaborative Initial Glaucoma Treatment Study (CIGTS), Collaborative Normal Tension Glaucoma (CNTG) Study, European Glaucoma Prevention Study (EGPS), Early Manifest Glaucoma Trial (EMGT), Glaucoma Laser Trial (GLT), Ocular Hypertension Treatment Study (OHTS), and Tube Versus Trabeculectomy (TVT) Study. A 5-point Likert scale was used for rating all responses. The practice setting and duration of glaucoma practice was determined for all AGS members who responded. A total of 206 (23.0%) of 894 AGS members participated in the survey. Among those who responded, 46.4% were self classified as academic practitioners and 53.6% worked in a private practice setting. Mean Likert scores for the standard question evaluating the overall impact of the RCT were OHTS 4.47, CNTG Study 4.13, AGIS 3.78, TVT Study 3.53, EMGT 3.48, CIGTS 3.44, GLT 3.39, and 2.69 EGPS. Substantial differences were observed in the clinical impact of several RCTs in glaucoma. The reported impact of each study likely reflects several factors including study timing, design, conduct, and interpretation of results.

Coronagraph Focal-Plane Phase Masks Based on Photonic Crystal Technology: Recent Progress and Observational Strategy

NASA Technical Reports Server (NTRS)

Murakami, Naoshi; Nishikawa, Jun; Sakamoto, Moritsugu; Ise, Akitoshi; Oka, Kazuhiko; Baba, Naoshi; Murakami, Hiroshi; Tamura, Motohide; Traub, Wesley A.; Mawet, Dimitri;

[BRAVO and CRUISE: ranibizumab for the treatment of macular edema secondary to retinal vein occlusion].

PubMed

Figueroa, M S; Ruiz Moreno, J M

2012-12-01

This article summarizes the results of the BRAVO and CRUISE trials, two randomized multicenter studies in patients with macular edema secondary to branch and central retinal vein occlusion, respectively. Randomization was 1:1:1 to 0.3 mg of ranibizumab, 0.5 mg of ranibizumab or placebo. Monthly injections were administered for 6 months followed by a 6-month observation period in which treatment on an on-demand (PRN) basis was applied with 0.5 mg ranibizumab. Patients in the control group were also eligible for 0.5 mg ranibizumab treatment in the observation period. The results showed a significant anatomical and visual improvement in both treatment groups 7 days after the intravitreal injection. PRN treatment with monthly follow-up maintained the visual improvements achieved after the first 6 months of treatment. Patients in the control group who received PRN treatment after the first 6 months showed an anatomical improvement similar to that in the treatment groups but less visual improvement.

Arterial Obstruction on Computed Tomographic or Magnetic Resonance Angiography and Response to Intravenous Thrombolytics in Ischemic Stroke

PubMed Central

Mair, Grant; von Kummer, Rüdiger; Adami, Alessandro; White, Philip M.; Adams, Matthew E.; Yan, Bernard; Demchuk, Andrew M.; Farrall, Andrew J.; Sellar, Robin J.; Sakka, Eleni; Palmer, Jeb; Perry, David; Lindley, Richard I.; Sandercock, Peter A.G.

2017-01-01

Background and Purpose— Computed tomographic angiography and magnetic resonance angiography are used increasingly to assess arterial patency in patients with ischemic stroke. We determined which baseline angiography features predict response to intravenous thrombolytics in ischemic stroke using randomized controlled trial data. Methods— We analyzed angiograms from the IST-3 (Third International Stroke Trial), an international, multicenter, prospective, randomized controlled trial of intravenous alteplase. Readers, masked to clinical, treatment, and outcome data, assessed prerandomization computed tomographic angiography and magnetic resonance angiography for presence, extent, location, and completeness of obstruction and collaterals. We compared angiography findings to 6-month functional outcome (Oxford Handicap Scale) and tested for interactions with alteplase, using ordinal regression in adjusted analyses. We also meta-analyzed all available angiography data from other randomized controlled trials of intravenous thrombolytics. Results— In IST-3, 300 patients had prerandomization angiography (computed tomographic angiography=271 and magnetic resonance angiography=29). On multivariable analysis, more extensive angiographic obstruction and poor collaterals independently predicted poor outcome (P<0.01). We identified no significant interaction between angiography findings and alteplase effect on Oxford Handicap Scale (P≥0.075) in IST-3. In meta-analysis (5 trials of alteplase or desmoteplase, including IST-3, n=591), there was a significantly increased benefit of thrombolytics on outcome (odds ratio>1 indicates benefit) in patients with (odds ratio, 2.07; 95% confidence interval, 1.18–3.64; P=0.011) versus without (odds ratio, 0.88; 95% confidence interval, 0.58–1.35; P=0.566) arterial obstruction (P for interaction 0.017). Conclusions— Intravenous thrombolytics provide benefit to stroke patients with computed tomographic angiography or magnetic resonance angiography evidence of arterial obstruction, but the sample was underpowered to demonstrate significant treatment benefit or harm among patients with apparently patent arteries. Clinical Trial Registration— URL: http://www.isrctn.com. Unique identifier: ISRCTN25765518. PMID:28008093

Arterial Obstruction on Computed Tomographic or Magnetic Resonance Angiography and Response to Intravenous Thrombolytics in Ischemic Stroke.

PubMed

Mair, Grant; von Kummer, Rüdiger; Adami, Alessandro; White, Philip M; Adams, Matthew E; Yan, Bernard; Demchuk, Andrew M; Farrall, Andrew J; Sellar, Robin J; Sakka, Eleni; Palmer, Jeb; Perry, David; Lindley, Richard I; Sandercock, Peter A G; Wardlaw, Joanna M

2017-02-01

Computed tomographic angiography and magnetic resonance angiography are used increasingly to assess arterial patency in patients with ischemic stroke. We determined which baseline angiography features predict response to intravenous thrombolytics in ischemic stroke using randomized controlled trial data. We analyzed angiograms from the IST-3 (Third International Stroke Trial), an international, multicenter, prospective, randomized controlled trial of intravenous alteplase. Readers, masked to clinical, treatment, and outcome data, assessed prerandomization computed tomographic angiography and magnetic resonance angiography for presence, extent, location, and completeness of obstruction and collaterals. We compared angiography findings to 6-month functional outcome (Oxford Handicap Scale) and tested for interactions with alteplase, using ordinal regression in adjusted analyses. We also meta-analyzed all available angiography data from other randomized controlled trials of intravenous thrombolytics. In IST-3, 300 patients had prerandomization angiography (computed tomographic angiography=271 and magnetic resonance angiography=29). On multivariable analysis, more extensive angiographic obstruction and poor collaterals independently predicted poor outcome (P<0.01). We identified no significant interaction between angiography findings and alteplase effect on Oxford Handicap Scale (P≥0.075) in IST-3. In meta-analysis (5 trials of alteplase or desmoteplase, including IST-3, n=591), there was a significantly increased benefit of thrombolytics on outcome (odds ratio>1 indicates benefit) in patients with (odds ratio, 2.07; 95% confidence interval, 1.18-3.64; P=0.011) versus without (odds ratio, 0.88; 95% confidence interval, 0.58-1.35; P=0.566) arterial obstruction (P for interaction 0.017). Intravenous thrombolytics provide benefit to stroke patients with computed tomographic angiography or magnetic resonance angiography evidence of arterial obstruction, but the sample was underpowered to demonstrate significant treatment benefit or harm among patients with apparently patent arteries. URL: http://www.isrctn.com. Unique identifier: ISRCTN25765518. © 2016 The Authors.

Suboxide/subnitride formation on Ta masks during magnetic material etching by reactive plasmas

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

Li, Hu; Muraki, Yu; Karahashi, Kazuhiro

2015-07-15

Etching characteristics of tantalum (Ta) masks used in magnetoresistive random-access memory etching processes by carbon monoxide and ammonium (CO/NH{sub 3}) or methanol (CH{sub 3}OH) plasmas have been examined by mass-selected ion beam experiments with in-situ surface analyses. It has been suggested in earlier studies that etching of magnetic materials, i.e., Fe, Ni, Co, and their alloys, by such plasmas is mostly due to physical sputtering and etch selectivity of the process arises from etch resistance (i.e., low-sputtering yield) of the hard mask materials such as Ta. In this study, it is shown that, during Ta etching by energetic CO{sup +}more » or N{sup +} ions, suboxides or subnitrides are formed on the Ta surface, which reduces the apparent sputtering yield of Ta. It is also shown that the sputtering yield of Ta by energetic CO{sup +} or N{sup +} ions has a strong dependence on the angle of ion incidence, which suggests a correlation between the sputtering yield and the oxidation states of Ta in the suboxide or subnitride; the higher the oxidation state of Ta, the lower is the sputtering yield. These data account for the observed etch selectivity by CO/NH{sub 3} and CH{sub 3}OH plasmas.« less

Masking with faces in central visual field under a variety of temporal schedules.

PubMed

Daar, Marwan; Wilson, Hugh R

2015-11-01

With a few exceptions, previous studies have explored masking using either a backward mask or a common onset trailing mask, but not both. In a series of experiments, we demonstrate the use of faces in central visual field as a viable method to study the relationship between these two types of mask schedule. We tested observers in a two alternative forced choice face identification task, where both target and mask comprised synthetic faces, and show that a simple model can successfully predict masking across a variety of masking schedules ranging from a backward mask to a common onset trailing mask and a number of intermediate variations. Our data are well accounted for by a window of sensitivity to mask interference that is centered at around 100 ms. Copyright © 2015 Elsevier Ltd. All rights reserved.

Are Masking-Based Models of Risk Useful?

PubMed

Gisiner, Robert C

2016-01-01

As our understanding of directly observable effects from anthropogenic sound exposure has improved, concern about "unobservable" effects such as stress and masking have received greater attention. Equal energy models of masking such as power spectrum models have the appeal of simplicity, but do they offer biologically realistic assessments of the risk of masking? Data relevant to masking such as critical ratios, critical bandwidths, temporal resolution, and directional resolution along with what is known about general mammalian antimasking mechanisms all argue for a much more complicated view of masking when making decisions about the risk of masking inherent in a given anthropogenic sound exposure scenario.

The mycotic ulcer treatment trial: a randomized trial comparing natamycin vs voriconazole.

PubMed

Prajna, N Venkatesh; Krishnan, Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Prajna, Lalitha; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E; Ray, Kathryn J; Zegans, Michael E; McLeod, Stephen D; Porco, Travis C; Acharya, Nisha R; Lietman, Thomas M

2013-04-01

To compare topical natamycin vs voriconazole in the treatment of filamentous fungal keratitis. This phase 3, double-masked, multicenter trial was designed to randomize 368 patients to voriconazole (1%) or natamycin (5%), applied topically every hour while awake until reepithelialization, then 4 times daily for at least 3 weeks. Eligibility included smear-positive filamentous fungal ulcer and visual acuity of 20/40 to 20/400. The primary outcome was best spectacle-corrected visual acuity at 3 months; secondary outcomes included corneal perforation and/or therapeutic penetrating keratoplasty. A total of 940 patients were screened and 323 were enrolled. Causative organisms included Fusarium (128 patients [40%]), Aspergillus (54 patients [17%]), and other filamentous fungi (141 patients [43%]). Natamycintreated cases had significantly better 3-month best spectacle-corrected visual acuity than voriconazole-treated cases (regression coefficient=0.18 logMAR; 95% CI, 0.30 to 0.05; P=.006). Natamycin-treated cases were less likely to have perforation or require therapeutic penetrating keratoplasty (odds ratio=0.42; 95% CI, 0.22 to 0.80; P=.009). Fusarium cases fared better with natamycin than with voriconazole (regression coefficient=0.41 logMAR; 95% CI,0.61 to 0.20; P<.001; odds ratio for perforation=0.06; 95% CI, 0.01 to 0.28; P<.001), while non-Fusarium cases fared similarly (regression coefficient=0.02 logMAR; 95% CI, 0.17 to 0.13; P=.81; odds ratio for perforation=1.08; 95% CI, 0.48 to 2.43; P=.86). Natamycin treatment was associated with significantly better clinical and microbiological outcomes than voriconazole treatment for smear-positive filamentous fungal keratitis, with much of the difference attributable to improved results in Fusarium cases. Voriconazole should not be used as monotherapy in filamentous keratitis. clinicaltrials.gov Identifier: NCT00996736

Control of spectral transmission enhancement properties of random anti-reflecting surface structures fabricated using gold masking

NASA Astrophysics Data System (ADS)

Peltier, Abigail; Sapkota, Gopal; Potter, Matthew; Busse, Lynda E.; Frantz, Jesse A.; Shaw, L. Brandon; Sanghera, Jasbinder S.; Aggarwal, Ishwar D.; Poutous, Menelaos K.

2017-02-01

Random anti-reflecting subwavelength surface structures (rARSS) have been shown to suppress Fresnel reflection and scatter from optical surfaces. The structures effectively function as a gradient-refractive-index at the substrate boundary, and the spectral transmission properties of the boundary have been shown to depend on the structure's statistical properties (diameter, height, and density.) We fabricated rARSS on fused silica substrates using gold masking. A thin layer of gold was deposited on the surface of the substrate and then subjected to a rapid thermal annealing (RTA) process at various temperatures. This RTA process resulted in the formation of gold "islands" on the surface of the substrate, which then acted as a mask while the substrate was dry etched in a reactive ion etching (RIE) process. The plasma etch yielded a fused silica surface covered with randomly arranged "rods" that act as the anti-reflective layer. We present data relating the physical characteristics of the gold "island" statistical populations, and the resulting rARSS "rod" population, as well as, optical scattering losses and spectral transmission properties of the final surfaces. We focus on comparing results between samples processed at different RTA temperatures, as well as samples fabricated without undergoing RTA, to relate fabrication process statistics to transmission enhancement values.

A prospective evaluation of open face masks for head and neck radiation therapy.

PubMed

Wiant, David; Squire, Sarah; Liu, Han; Maurer, Jacqueline; Lane Hayes, T; Sintay, Benjamin

Head and neck (HN) radiation therapy patients are typically immobilized with closed thermoplastic masks that cover the face and may cause discomfort. In this work, we examine the use of open masks for HN radiation therapy. Fifty HN patients were prospectively randomized into 2 groups (25 closed masks, 25 open masks). The open-mask group was monitored with surface imaging to evaluate intrafraction motion. Both groups underwent daily volumetric imaging. All daily images were rigidly registered to their respective planning images to evaluate spinal canal and mandible position as a check for interfraction posture change. Posture changes were determined by the amount the spinal canal and mandible contours from the planning images had to be expanded to cover the structures on each daily image set. The vector length (VL) of the intrafraction linear translations, spine, and mandible positions for each open-mask patient were checked for correlation with fraction number using the Pearson r value. All patients were given a weekly survey ranking anxiety and claustrophobia from 0 to 10 (0 = no issue, 10 = extreme issue). The mean VL for all open-mask patients was 0.9 ± 0.5 mm (1 standard deviation). Only 1 patient showed significant correlation between VL and fraction number. The mean contour expansions to cover the spine and mandible were 1.5 ± 0.9 mm and 1.8 ± 1.3 mm for the closed-mask group, and 1.6 ± 0.8 mm and 1.8 ± 1.1 mm for the open-mask group. Both groups showed similar behavior relative to fraction number. The mean anxiety and claustrophobia scores were 1.63 and 1.44 for the closed-mask group, and 0.81 and 0.63 for the open-mask group. The groups were not significantly different. Open masks provide comparable immobilization and posture preservation to closed masks for HN radiation therapy. Copyright © 2016 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.

Cluster randomised controlled trial to examine medical mask use as source control for people with respiratory illness.

PubMed

MacIntyre, Chandini Raina; Zhang, Yi; Chughtai, Abrar Ahmad; Seale, Holly; Zhang, Daitao; Chu, Yanhui; Zhang, Haiyan; Rahman, Bayzidur; Wang, Quanyi

2016-12-30

Medical masks are commonly used by sick individuals with influenza-like illness (ILI) to prevent spread of infections to others, but clinical efficacy data are absent. Determine whether medical mask use by sick individuals with ILI protects well contacts from related respiratory infections. 6 major hospitals in 2 districts of Beijing, China. Cluster randomised controlled trial. 245 index cases with ILI. Index cases with ILI were randomly allocated to medical mask (n=123) and control arms (n=122). Since 43 index cases in the control arm also used a mask during the study period, an as-treated post hoc analysis was performed by comparing outcomes among household members of index cases who used a mask (mask group) with household members of index cases who did not use a mask (no-mask group). Primary outcomes measured in household members were clinical respiratory illness, ILI and laboratory-confirmed viral respiratory infection. In an intention-to-treat analysis, rates of clinical respiratory illness (relative risk (RR) 0.61, 95% CI 0.18 to 2.13), ILI (RR 0.32, 95% CI 0.03 to 3.13) and laboratory-confirmed viral infections (RR 0.97, 95% CI 0.06 to 15.54) were consistently lower in the mask arm compared with control, although not statistically significant. A post hoc comparison between the mask versus no-mask groups showed a protective effect against clinical respiratory illness, but not against ILI and laboratory-confirmed viral respiratory infections. The study indicates a potential benefit of medical masks for source control, but is limited by small sample size and low secondary attack rates. Larger trials are needed to confirm efficacy of medical masks as source control. ACTRN12613000852752; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Cluster randomised controlled trial to examine medical mask use as source control for people with respiratory illness

PubMed Central

MacIntyre, Chandini Raina; Zhang, Yi; Chughtai, Abrar Ahmad; Seale, Holly; Zhang, Daitao; Chu, Yanhui; Zhang, Haiyan; Rahman, Bayzidur; Wang, Quanyi

2016-01-01

Rationale Medical masks are commonly used by sick individuals with influenza-like illness (ILI) to prevent spread of infections to others, but clinical efficacy data are absent. Objective Determine whether medical mask use by sick individuals with ILI protects well contacts from related respiratory infections. Setting 6 major hospitals in 2 districts of Beijing, China. Design Cluster randomised controlled trial. Participants 245 index cases with ILI. Intervention Index cases with ILI were randomly allocated to medical mask (n=123) and control arms (n=122). Since 43 index cases in the control arm also used a mask during the study period, an as-treated post hoc analysis was performed by comparing outcomes among household members of index cases who used a mask (mask group) with household members of index cases who did not use a mask (no-mask group). Main outcome measure Primary outcomes measured in household members were clinical respiratory illness, ILI and laboratory-confirmed viral respiratory infection. Results In an intention-to-treat analysis, rates of clinical respiratory illness (relative risk (RR) 0.61, 95% CI 0.18 to 2.13), ILI (RR 0.32, 95% CI 0.03 to 3.13) and laboratory-confirmed viral infections (RR 0.97, 95% CI 0.06 to 15.54) were consistently lower in the mask arm compared with control, although not statistically significant. A post hoc comparison between the mask versus no-mask groups showed a protective effect against clinical respiratory illness, but not against ILI and laboratory-confirmed viral respiratory infections. Conclusions The study indicates a potential benefit of medical masks for source control, but is limited by small sample size and low secondary attack rates. Larger trials are needed to confirm efficacy of medical masks as source control. Trial registration number ACTRN12613000852752; Results. PMID:28039289

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

Kalavagunta, C; Lin, M; Snider, J

Purpose: To quantify the factors leading to thermoplastic mask bolus-associated-increased skin dose in head and neck IMRT/VMAT using EBT2 film. Methods: EBT2 film placed beneath a dual layer 3-point ORFIT head, neck and shoulder mask was used to test the effect of mask thickness, beam modulation, air gap, and beam obliquity on bolus effect. Mask thickness was varied based on the distribution of 1.6mm Orfilight layer on top of 2 mm Efficast layer. Beam modulation was varied by irradiating the film with an open field (no beam modulation) and a step and shoot field (beam modulation). Air gap between maskmore » and film was varied from 0 to 5mm. Beam obliquity was varied by irradiating the film at gantry angles of 0°, 35°, and 70°.Finally, film strips placed on a Rando phantom under an Orfit mask, in regions of expected high dose, were irradiated using 5 IMRT and 5 VMAT plans with various modulation levels (modulation factor 2 to 5) and the results were compared with those obtained placing OSLDs at the same locations. Results: An 18–34% increase in mask bolus effect was observed for three factors where the effect of beam obliquity ≥ beam modulation > mask thickness. No increase in mask bolus effect was observed for change in air gap. A 6–13% increase in dose due to mask bolus effect was observed on film strips. Conclusion: This work underlines the role of beam obliquity and beam modulation combined with thermoplastic mask thickness in increasing mask bolus-associated skin dose in head and neck IMRT/VMAT. One possible method of dose reduction, based on knowledge gained from this work, is inclusion of skin as an avoidance structure in treatment planning. Another approach is to design a mask with the least amount of thermoplastic material necessary for immobilization.« less

Mask leak increases and minute ventilation decreases when chest compressions are added to bag ventilation in a neonatal manikin model.

PubMed

Tracy, Mark B; Shah, Dharmesh; Hinder, Murray; Klimek, Jan; Marceau, James; Wright, Audrey

2014-05-01

To determine changes in respiratory mechanics when chest compressions are added to mask ventilation, as recommended by the International Liaison Committee on Resuscitation (ILCOR) guidelines for newborn infants. Using a Laerdal Advanced Life Support leak-free baby manikin and a 240-mL self-inflating bag, 58 neonatal staff members were randomly paired to provide mask ventilation, followed by mask ventilation with chest compressions with a 1:3 ratio, for two minutes each. A Florian respiratory function monitor was used to measure respiratory mechanics, including mask leak. The addition of chest compressions to mask ventilation led to a significant reduction in inflation rate, from 63.9 to 32.9 breaths per minute (p < 0.0001), mean airway pressure reduced from 7.6 to 4.9 cm H2 O (p < 0.001), minute ventilation reduced from 770 to 451 mL/kg/min (p < 0.0001), and there was a significant increase in paired mask leak of 6.8% (p < 0.0001). Adding chest compressions to mask ventilation, in accordance with the ILCOR guidelines, in a manikin model is associated with a significant reduction in delivered ventilation and increase in mask leak. If similar findings occur in human infants needing an escalation in resuscitation, there is a potential risk of either delay in recovery or inadequate response to resuscitation. ©2014 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

An observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment.

PubMed

Jepson, Marcus; Elliott, Daisy; Conefrey, Carmel; Wade, Julia; Rooshenas, Leila; Wilson, Caroline; Beard, David; Blazeby, Jane M; Birtle, Alison; Halliday, Alison; Stein, Rob; Donovan, Jenny L

2018-07-01

To explore how the concept of randomization is described by clinicians and understood by patients in randomized controlled trials (RCTs) and how it contributes to patient understanding and recruitment. Qualitative analysis of 73 audio recordings of recruitment consultations from five, multicenter, UK-based RCTs with identified or anticipated recruitment difficulties. One in 10 appointments did not include any mention of randomization. Most included a description of the method or process of allocation. Descriptions often made reference to gambling-related metaphors or similes, or referred to allocation by a computer. Where reference was made to a computer, some patients assumed that they would receive the treatment that was "best for them". Descriptions of the rationale for randomization were rarely present and often only came about as a consequence of patients questioning the reason for a random allocation. The methods and processes of randomization were usually described by recruiters, but often without clarity, which could lead to patient misunderstanding. The rationale for randomization was rarely mentioned. Recruiters should avoid problematic gambling metaphors and illusions of agency in their explanations and instead focus on clearer descriptions of the rationale and method of randomization to ensure patients are better informed about randomization and RCT participation. Copyright © 2018 University of Bristol. Published by Elsevier Inc. All rights reserved.

Applying Triple-Matrix Masking for Privacy Preserving Data Collection and Sharing in HIV Studies.

PubMed

Pei, Qinglin; Chen, Shigang; Xiao, Yao; Wu, Samuel S

2016-01-01

Many HIV research projects are plagued by the high missing rate of selfreported information during data collection. Also, due to the sensitive nature of the HIV research data, privacy protection is always a concern for data sharing in HIV studies. This paper applies a data masking approach, called triple-matrix masking [1], to the context of HIV research for ensuring privacy protection during the process of data collection and data sharing. Using a set of generated HIV patient data, we show step by step how the data are randomly transformed (masked) before leaving the patients' individual data collection device (which ensures that nobody sees the actual data) and how the masked data are further transformed by a masking service provider and a data collector. We demonstrate that the masked data retain statistical utility of the original data, yielding the exactly same inference results in the planned logistic regression on the effect of age on the adherence to antiretroviral therapy and in the Cox proportional hazard model for the age effect on time to viral load suppression. Privacy-preserving data collection method may help resolve the privacy protection issue in HIV research. The individual sensitive data can be completely hidden while the same inference results can still be obtained from the masked data, with the use of common statistical analysis methods.

A Randomized Multicenter Clinical Trial of Ultrathin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) versus DSAEK.

PubMed

Dickman, Mor M; Kruit, Pieter J; Remeijer, Lies; van Rooij, Jeroen; Van der Lelij, Allegonda; Wijdh, Robert H J; van den Biggelaar, Frank J H M; Berendschot, Tos T J M; Nuijts, Rudy M M A

2016-11-01

To compare visual acuity, refraction, endothelial cell density (ECD), and complications after Descemet stripping automated endothelial keratoplasty (DSAEK) and ultrathin DSAEK (UT-DSAEK). A multicenter, prospective, double-masked, randomized, controlled clinical trial. From 66 patients with irreversible corneal endothelial dysfunction dues to Fuchs' dystrophy who enrolled from 4 tertiary medical centers in the Netherlands, 66 eyes were studied. Participants were centrally randomized to undergo either UT-DSAEK or DSAEK, based on preoperative best spectacle-corrected visual acuity (BSCVA), recipient central corneal thickness, patient age, and recruitment center. Donor corneas were precut by a single cornea bank. Participants underwent ophthalmic examinations preoperatively and 3, 6, and 12 months after the operation, including manifest refraction, BSCVA using an Early Treatment Diabetic Retinopathy Study chart, and endothelium imaging. BSCVA 12 months postoperatively. Preoperative BSCVA did not differ between patients undergoing DSAEK (0.35 logarithm of the minimum angle of resolution [logMAR] [95% confidence interval {CI} 0.27-0.43]; n = 32) and UT-DSAEK (0.37 logMAR [95% CI 0.31-0.43]; n = 34; P = 0.8). BSCVA was significantly better after UT-DSAEK compared with that after DSAEK at 3 months (0.17 logMAR [95% CI 0.13-0.21], n = 31 vs. 0.28 logMAR [95% CI 0.23-0.33], n = 31; P = 0.001), 6 months (0.14 logMAR [95% CI 0.10-0.18], n = 30 vs. 0.24 logMAR [95% CI 0.20-0.28], n = 30; P = 0.002), and 12 months (0.13 logMAR [95% CI 0.09-0.17], n = 33 vs. 0.20 logMAR [95% CI 0.15-0.25], n = 29; P = 0.03). Refraction, ECD loss (40% at 3 months; P < 0.001), donor loss (DSAEK n = 2 vs. UT-DSAEK n = 3 [relative risk {RR} 1.4 {95% CI 0.24-7.5}; P = 0.7]), and graft dislocation (DSAEK n = 5 vs. UT-DSAEK n = 5 [RR 1.0 {95% CI 0.34-3.33}; P = 0.9]) did not differ between UT-DSAEK and DSAEK. Donor thickness was significantly thinner for UT-DSAEK (101 μm [95% CI 93-110 μm]; range 50-145 μm) than for DSAEK (209 μm [95% CI 196-222 μm]; range 147-289 μm; P < 0.001). This study indicates that compared with DSAEK, UT-DSAEK results in faster and better recovery of BSCVA with similar refractive outcomes, endothelial cell loss, and incidence of complications. Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Effect of berberine on insulin resistance in women with polycystic ovary syndrome: study protocol for a randomized multicenter controlled trial.

PubMed

Li, Yan; Ma, Hongli; Zhang, Yuehui; Kuang, Hongying; Ng, Ernest Hung Yu; Hou, Lihui; Wu, Xiaoke

2013-07-18

Insulin resistance and hyperinsulinemia play a key role in the pathogenesis of polycystic ovary syndrome (PCOS), which is characterized by hyperandrogenism, ovulatory dysfunction, and presence of polycystic ovaries on pelvic scanning. Insulin resistance is significantly associated with the long-term risks of metabolic syndrome and cardiovascular disease. Berberine has effects on insulin resistance but its use in women with PCOS has not been fully investigated. In this paper, we present a research design evaluating the effects of berberine on insulin resistance in women with PCOS. This is a multicenter, randomized, placebo-controlled and double-blind trial. A total of 120 patients will be enrolled in this study and will be randomized into two groups. Berberine or placebo will be taken orally for 12 weeks. The primary outcome is the whole body insulin action assessed with the hyperinsulinemic-euglycemic clamp. We postulate that women with PCOS will have improved insulin resistance following berberine administration. This study is registered at ClinicalTrials.gov, NCT01138930.

Switching from usual brand cigarettes to a tobacco-heating cigarette or snus: Part 3. Biomarkers of biological effect

PubMed Central

Ogden, Michael W.; Marano, Kristin M.; Jones, Bobbette A.; Morgan, Walter T.; Stiles, Mitchell F.

2015-01-01

Abstract A randomized, multi-center study of adult cigarette smokers switched to tobacco-heating cigarettes, snus or ultra-low machine yield tobacco-burning cigarettes (50/group) for 24 weeks was conducted. Evaluation of biomarkers of biological effect (e.g. inflammation, lipids, hypercoaguable state) indicated that the majority of consistent and statistically significant improvements over time within each group were observed in markers of inflammation. Consistent and statistically significant differences in pairwise comparisons between product groups were not observed. These findings are relevant to the understanding of biomarkers of biological effect related to cigarette smoking as well as the risk continuum across various tobacco products (ClinicalTrials.gov Identifier: NCT02061917). PMID:26525962

Patient characteristics associated with improved outcomes with use of an inhaled corticosteroid in preschool children at risk for asthma.

PubMed

Bacharier, Leonard B; Guilbert, Theresa W; Zeiger, Robert S; Strunk, Robert C; Morgan, Wayne J; Lemanske, Robert F; Moss, Mark; Szefler, Stanley J; Krawiec, Marzena; Boehmer, Susan; Mauger, David; Taussig, Lynn M; Martinez, Fernando D

2009-05-01

Maintenance inhaled corticosteroid (ICS) therapy in preschool children with recurrent wheezing at high-risk for development of asthma produces multiple clinical benefits. However, determination of baseline features associated with ICS responsiveness may identify children most likely to benefit from ICS treatment. To determine if demographic and atopic features predict response to ICS in preschool children at high risk for asthma. Two years of treatment with an ICS, fluticasone propionate (88 microg twice daily), was compared with matching placebo in a double-masked, randomized, multicenter study of 285 children 2 and 3 years old at high risk for asthma development. Baseline demographic and atopic features were related to clinical outcomes in a post hoc subgroup analysis. Multivariate analysis demonstrated significantly greater improvement with fluticasone than placebo in terms of episode-free days among boys, white subjects, participants with an emergency department (ED) visit or hospitalization within the past year, and those who experienced more symptomatic days at baseline. Children with aeroallergen sensitization experienced greater benefits in terms of oral corticosteroid use, urgent care and ED visits, and use of supplemental controller medications. More favorable responses to ICS than placebo in high-risk preschool children over a 2-year period were more likely in those with a ED visit or hospitalization for asthma within the past year, children with aeroallergen sensitization, boys, and white subjects.

Effect of SPM-based cleaning POR on EUV mask performance

NASA Astrophysics Data System (ADS)

Choi, Jaehyuck; Lee, Han-shin; Yoon, Jinsang; Shimomura, Takeya; Friz, Alex; Montgomery, Cecilia; Ma, Andy; Goodwin, Frank; Kang, Daehyuk; Chung, Paul; Shin, Inkyun; Cho, H.

2011-11-01

EUV masks include many different layers of various materials rarely used in optical masks, and each layer of material has a particular role in enhancing the performance of EUV lithography. Therefore, it is crucial to understand how the mask quality and patterning performance can change during mask fabrication, EUV exposure, maintenance cleaning, shipping, or storage. The fact that a pellicle is not used to protect the mask surface in EUV lithography suggests that EUV masks may have to undergo more cleaning cycles during their lifetime. More frequent cleaning, combined with the adoption of new materials for EUV masks, necessitates that mask manufacturers closely examine the performance change of EUV masks during cleaning process. We have investigated EUV mask quality and patterning performance during 30 cycles of Samsung's EUV mask SPM-based cleaning and 20 cycles of SEMATECH ADT exposure. We have observed that the quality and patterning performance of EUV masks does not significantly change during these processes except mask pattern CD change. To resolve this issue, we have developed an acid-free cleaning POR and substantially improved EUV mask film loss compared to the SPM-based cleaning POR.

Influence of auditory fatigue on masked speech intelligibility

NASA Technical Reports Server (NTRS)

Parker, D. E.; Martens, W. L.; Johnston, P. A.

1980-01-01

Intelligibility of PB word lists embedded in simultaneous masking noise was evaluated before and after fatiguing-noise exposure, which was determined by observing the number of words correctly repeated during a shadowing task. Both the speech signal and the masking noise were filtered to a 2825-3185-Hz band. Masking-noise leves were varied from 0- to 90-dB SL. Fatigue was produced by a 1500-3000-Hz octave band of noise at 115 dB (re 20 micron-Pa) presented continuously for 5 min. The results of three experiments indicated that speed intelligibility was reduced when the speech was presented against a background of silence but that the fatiguing-noise exposure had no effect on intelligibility when the speech was made more intense and embedded in masking noise of 40-90-dB SL. These observations are interpreted by considering the recruitment produced by fatigue and masking noise.

Effect of Bag-Mask Ventilation vs Endotracheal Intubation During Cardiopulmonary Resuscitation on Neurological Outcome After Out-of-Hospital Cardiorespiratory Arrest: A Randomized Clinical Trial.

PubMed

Jabre, Patricia; Penaloza, Andrea; Pinero, David; Duchateau, Francois-Xavier; Borron, Stephen W; Javaudin, Francois; Richard, Olivier; de Longueville, Diane; Bouilleau, Guillem; Devaud, Marie-Laure; Heidet, Matthieu; Lejeune, Caroline; Fauroux, Sophie; Greingor, Jean-Luc; Manara, Alessandro; Hubert, Jean-Christophe; Guihard, Bertrand; Vermylen, Olivier; Lievens, Pascale; Auffret, Yannick; Maisondieu, Celine; Huet, Stephanie; Claessens, Benoît; Lapostolle, Frederic; Javaud, Nicolas; Reuter, Paul-Georges; Baker, Elinor; Vicaut, Eric; Adnet, Frédéric

2018-02-27

Bag-mask ventilation (BMV) is a less complex technique than endotracheal intubation (ETI) for airway management during the advanced cardiac life support phase of cardiopulmonary resuscitation of patients with out-of-hospital cardiorespiratory arrest. It has been reported as superior in terms of survival. To assess noninferiority of BMV vs ETI for advanced airway management with regard to survival with favorable neurological function at day 28. Multicenter randomized clinical trial comparing BMV with ETI in 2043 patients with out-of-hospital cardiorespiratory arrest in France and Belgium. Enrollment occurred from March 9, 2015, to January 2, 2017, and follow-up ended January 26, 2017. Participants were randomized to initial airway management with BMV (n = 1020) or ETI (n = 1023). The primary outcome was favorable neurological outcome at 28 days defined as cerebral performance category 1 or 2. A noninferiority margin of 1% was chosen. Secondary end points included rate of survival to hospital admission, rate of survival at day 28, rate of return of spontaneous circulation, and ETI and BMV difficulty or failure. Among 2043 patients who were randomized (mean age, 64.7 years; 665 women [32%]), 2040 (99.8%) completed the trial. In the intention-to-treat population, favorable functional survival at day 28 was 44 of 1018 patients (4.3%) in the BMV group and 43 of 1022 patients (4.2%) in the ETI group (difference, 0.11% [1-sided 97.5% CI, -1.64% to infinity]; P for noninferiority = .11). Survival to hospital admission (294/1018 [28.9%] in the BMV group vs 333/1022 [32.6%] in the ETI group; difference, -3.7% [95% CI, -7.7% to 0.3%]) and global survival at day 28 (55/1018 [5.4%] in the BMV group vs 54/1022 [5.3%] in the ETI group; difference, 0.1% [95% CI, -1.8% to 2.1%]) were not significantly different. Complications included difficult airway management (186/1027 [18.1%] in the BMV group vs 134/996 [13.4%] in the ETI group; difference, 4.7% [95% CI, 1.5% to 7.9%]; P = .004), failure (69/1028 [6.7%] in the BMV group vs 21/996 [2.1%] in the ETI group; difference, 4.6% [95% CI, 2.8% to 6.4%]; P < .001), and regurgitation of gastric content (156/1027 [15.2%] in the BMV group vs 75/999 [7.5%] in the ETI group; difference, 7.7% [95% CI, 4.9% to 10.4%]; P < .001). Among patients with out-of-hospital cardiorespiratory arrest, the use of BMV compared with ETI failed to demonstrate noninferiority or inferiority for survival with favorable 28-day neurological function, an inconclusive result. A determination of equivalence or superiority between these techniques requires further research. clinicaltrials.gov Identifier: NCT02327026.

Accounting for center in the Early External Cephalic Version trials: an empirical comparison of statistical methods to adjust for center in a multicenter trial with binary outcomes.

PubMed

Reitsma, Angela; Chu, Rong; Thorpe, Julia; McDonald, Sarah; Thabane, Lehana; Hutton, Eileen

2014-09-26

Clustering of outcomes at centers involved in multicenter trials is a type of center effect. The Consolidated Standards of Reporting Trials Statement recommends that multicenter randomized controlled trials (RCTs) should account for center effects in their analysis, however most do not. The Early External Cephalic Version (EECV) trials published in 2003 and 2011 stratified by center at randomization, but did not account for center in the analyses, and due to the nature of the intervention and number of centers, may have been prone to center effects. Using data from the EECV trials, we undertook an empirical study to compare various statistical approaches to account for center effect while estimating the impact of external cephalic version timing (early or delayed) on the outcomes of cesarean section, preterm birth, and non-cephalic presentation at the time of birth. The data from the EECV pilot trial and the EECV2 trial were merged into one dataset. Fisher's exact method was used to test the overall effect of external cephalic version timing unadjusted for center effects. Seven statistical models that accounted for center effects were applied to the data. The models included: i) the Mantel-Haenszel test, ii) logistic regression with fixed center effect and fixed treatment effect, iii) center-size weighted and iv) un-weighted logistic regression with fixed center effect and fixed treatment-by-center interaction, iv) logistic regression with random center effect and fixed treatment effect, v) logistic regression with random center effect and random treatment-by-center interaction, and vi) generalized estimating equations. For each of the three outcomes of interest approaches to account for center effect did not alter the overall findings of the trial. The results were similar for the majority of the methods used to adjust for center, illustrating the robustness of the findings. Despite literature that suggests center effect can change the estimate of effect in multicenter trials, this empirical study does not show a difference in the outcomes of the EECV trials when accounting for center effect. The EECV2 trial was registered on 30 July 30 2005 with Current Controlled Trials: ISRCTN 56498577.

Follow-up of colorectal cancer patients after resection with curative intent-the GILDA trial.

PubMed

Grossmann, Erik M; Johnson, Frank E; Virgo, Katherine S; Longo, Walter E; Fossati, Rolando

2004-01-01

Surgery remains the primary treatment of colorectal cancer. Data are lacking to delineate the optimal surveillance strategy following resection. A large-scale multi-center European study is underway to address this issue (Gruppo Italiano di Lavoro per la Diagnosi Anticipata-GILDA). Following primary surgery with curative intent, stratification, and randomization at GILDA headquarters, colon cancer patients are then assigned to a more intensive or less intensive surveillance regimen. Rectal cancer patients undergoing curative resection are similarly randomized, with their follow-up regimens placing more emphasis on detection of local recurrence. Target recruitment for the study will be 1500 patients to achieve a statistical power of 80% (assuming an alpha of 0.05 and a hazard-rate reduction of >24%). Since the trial opened in 1998, 985 patients have been randomized from 41 centers as of February 2004. There were 496 patients randomized to the less intensive regimens, and 489 randomized to the more intensive regimens. The mean duration of follow-up is 14 months. 75 relapses (15%) and 32 deaths (7%) had been observed in the two more intensive follow-up arms, while 64 relapses (13%) and 24 deaths (5%) had been observed in the two less intensive arms as of February 2004. This trial should provide the first evidence based on an adequately powered randomized trial to determine the optimal follow-up strategy for colorectal cancer patients. This trial is open to US centers, and recruitment continues.

[A multicenter, large-sample, randomized clinical trial on improving the median survival time of advanced non-small cell lung cancer by combination of Ginseng Rg3 and chemotherapy].

PubMed

Zhang, Y; Wang, X Q; Liu, H; Liu, J; Hou, W; Lin, H S

2018-04-23

Objective: To observe the efficacy of the combination of chemotherapy and Ginseng Rg3 on advanced non-small cell lung cancer(NSCLC). Methods: In the multi-center, large-sample, randomized, double blind trial, 414 patients with Ⅲ-Ⅳ NSCLC were enrolled.199 were in the experimental group and 215 the control group. The patients in the experimental group were treated with the standard first-line chemotherapy combined with Ginseng Rg3. The patients in the control group were treated with the same chemotherapy combined with placebo. Median overall survival (OS), Karnofsky performance scale (KPS), Traditional Chinese Medicine (TCM) symptoms score and side effects of two groups were observed as main indexes. Results: The median OS were 12.03 months in the experimental group, which was significantly better than that in the control group (8.46 months, P <0.05). Hemoglobin and white blood cells were decreased after the first and second cycle of treatment in both groups. Both adverse events were significantly milder in the treatment group ( P <0.05). In addition, after two courses of treatment, the KPS of patients was 78.95±9.14 in the experimental group and 76.77±9.15 in the control group, while the TCM symptoms score was 2.45±1.73 in the experimental group and 2.92±2.06 in the control group, with significant difference ( P <0.05). Conclusions: Combination of TCM with Western medicine such as chemotherapy could prolong the survival of patients with advanced NSCLC. The combined therapy improved patients' symptoms and reduced chemotherapy induced myelosuppression.

Performance of an Achromatic Focal Plane Mask for Exoplanet Imaging Coronagraphy

NASA Technical Reports Server (NTRS)

Newman, Kevin; Belikov, Ruslan; Pluzhnik, Eugene; Balasubramanian, Kunjithapatham; Wilson, Dan

2014-01-01

Coronagraph technology combined with wavefront control is close to achieving the contrast and inner working angle requirements in the lab necessary to observe the faint signal of an Earth-like exoplanet in monochromatic light. An important remaining technological challenge is to achieve high contrast in broadband light. Coronagraph bandwidth is largely limited by chromaticity of the focal plane mask, which is responsible for blocking the stellar PSF. The size of a stellar PSF scales linearly with wavelength; ideally, the size of the focal plane mask would also scale with wavelength. A conventional hard-edge focal plane mask has a fixed size, normally sized for the longest wavelength in the observational band to avoid starlight leakage. The conventional mask is oversized for shorter wavelengths and blocks useful discovery space. Recently we presented a solution to the size chromaticity challenge with a focal plane mask designed to scale its effective size with wavelength. In this paper, we analyze performance of the achromatic size-scaling focal plane mask within a Phase Induced Amplitude Apodization (PIAA) coronagraph. We present results from wavefront control around the achromatic focal plane mask, and demonstrate the size-scaling effect of the mask with wavelength. The edge of the dark zone, and therefore the inner working angle of the coronagraph, scale with wavelength. The achromatic mask enables operation in a wider band of wavelengths compared with a conventional hard-edge occulter.

The Effect of IV Amino Acid Supplementation on Mortality in ICU Patients May Be Dependent on Kidney Function: Post Hoc Subgroup Analyses of a Multicenter Randomized Trial.

PubMed

Zhu, Ran; Allingstrup, Matilde J; Perner, Anders; Doig, Gordon S

2018-05-15

We investigated whether preexisting kidney function determines if ICU patients may benefit from increased (2.0 g/kg/d) protein intake. Post hoc, hypothesis-generating, subgroup analysis of a multicenter, phase 2, randomized clinical trial. All analyses were conducted by intention to treat and maintained group allocation. Ninety-day mortality was the primary outcome. ICUs of 16 hospitals throughout Australia and New Zealand. Adult critically ill patients expected to remain in the study ICU for longer than 2 days. Random allocation to receive a daily supplement of up to 100 g of IV amino acids to achieve a total protein intake of 2.0 g/kg/d or standard nutrition care. A total of 474 patients were randomized: 235 to standard care and 239 to IV amino acid supplementation. There was a statistically significant interaction between baseline kidney function and supplementation with study amino acids (p value for interaction = 0.026). Within the subgroup of patients with normal kidney function at randomization, patients who were allocated to receive the study amino acid supplement were less likely to die before study day 90 (covariate-adjusted risk difference, -7.9%; 95% CI, -15.1 to -0.7; p = 0.034). Furthermore, amino acid supplementation significantly increased estimated glomerular filtration rate in these patients (repeated-measures treatment × time interaction p = 0.009). Within the subgroup of patients with baseline kidney dysfunction and/or risk of progression of acute kidney injury, a significant effect of the study intervention on mortality was not found (covariate-adjusted risk difference, -0.6%; 95% CI, -16.2 to 15.2; p = 0.95). In this post hoc, hypothesis-generating, subgroup analysis, we observed reduced mortality and improved estimated glomerular filtration rate in ICU patients with normal kidney function who were randomly allocated to receive increased protein intake (up to 2.0 g/kg/d). We strongly recommend confirmation of these results in trials with low risk of bias before this treatment is recommended for routine care.

Demonstration of holographic smart card system using the optical memory technology

NASA Astrophysics Data System (ADS)

Kim, JungHoi; Choi, JaeKwang; An, JunWon; Kim, Nam; Lee, KwonYeon; Jeon, SeckHee

2003-05-01

In this paper, we demonstrate the holographic smart card system using digital holographic memory technique that uses reference beam encrypted by the random phase mask to prevent unauthorized users from accessing the stored digital page. The input data that include document data, a picture of face, and a fingerprint for identification is encoded digitally and then coupled with the reference beam modulated by a random phase mask. Therefore, this proposed system can execute recording in the order of MB~GB and readout all personal information from just one card without any additional database system. Also, recorded digital holograms can't be reconstructed without a phase key and can't be copied by using computers, scanners, or photography.

Prediction and outcomes of impossible mask ventilation: a review of 50,000 anesthetics.

PubMed

Kheterpal, Sachin; Martin, Lizabeth; Shanks, Amy M; Tremper, Kevin K

2009-04-01

There are no existing data regarding risk factors for impossible mask ventilation and limited data regarding its incidence. The authors sought to determine the incidence, predictors, and outcomes associated with impossible mask ventilation. The authors performed an observational study over a 4-yr period. For each adult patient undergoing a general anesthetic, preoperative patient characteristics, detailed airway physical exam, and airway outcome data were collected. The primary outcome was impossible mask ventilation defined as the inability to exchange air during bag-mask ventilation attempts, despite multiple providers, airway adjuvants, or neuromuscular blockade. Secondary outcomes included the final, definitive airway management technique and direct laryngoscopy view. The incidence of impossible mask ventilation was calculated. Independent (P < 0.05) predictors of impossible mask ventilation were identified by performing a logistic regression full model fit. Over a 4-yr period from 2004 to 2008, 53,041 attempts at mask ventilation were recorded. A total of 77 cases of impossible mask ventilation (0.15%) were observed. Neck radiation changes, male sex, sleep apnea, Mallampati III or IV, and presence of beard were identified as independent predictors. The receiver-operating-characteristic area under the curve for this model was 0.80 +/- 0.03. Nineteen impossible mask ventilation patients (25%) also demonstrated difficult intubation, with 15 being intubated successfully. Twelve patients required an alternative intubation technique, including two surgical airways and two patients who were awakened and underwent successful fiberoptic intubation. Impossible mask ventilation is an infrequent airway event that is associated with difficult intubation. Neck radiation changes represent the most significant clinical predictor of impossible mask ventilation in the patient dataset.

Study and treatment of post Lyme disease (STOP-LD): a randomized double masked clinical trial.

PubMed

Krupp, L B; Hyman, L G; Grimson, R; Coyle, P K; Melville, P; Ahnn, S; Dattwyler, R; Chandler, B

2003-06-24

To determine whether post Lyme syndrome (PLS) is antibiotic responsive. The authors conducted a single-center randomized double-masked placebo-controlled trial on 55 patients with Lyme disease with persistent severe fatigue at least 6 or more months after antibiotic therapy. Patients were randomly assigned to receive 28 days of IV ceftriaxone or placebo. The primary clinical outcomes were improvement in fatigue, defined by a change of 0.7 points or more on an 11-item fatigue questionnaire, and improvement in cognitive function (mental speed), defined by a change of 25% or more on a test of reaction time. The primary laboratory outcome was an experimental measure of CSF infection, outer surface protein A (OspA). Outcome data were collected at the 6-month visit. Patients assigned to ceftriaxone showed improvement in disabling fatigue compared to the placebo group (rate ratio, 3.5; 95% CI, 1.50 to 8.03; p = 0.001). No beneficial treatment effect was observed for cognitive function or the laboratory measure of persistent infection. Four patients, three of whom were on placebo, had adverse events associated with treatment, which required hospitalization. Ceftriaxone therapy in patients with PLS with severe fatigue was associated with an improvement in fatigue but not with cognitive function or an experimental laboratory measure of infection in this study. Because fatigue (a nonspecific symptom) was the only outcome that improved and because treatment was associated with adverse events, this study does not support the use of additional antibiotic therapy with parenteral ceftriaxone in post-treatment, persistently fatigued patients with PLS.

Mask process correction (MPC) modeling and its application to EUV mask for electron beam mask writer EBM-7000

NASA Astrophysics Data System (ADS)

Kamikubo, Takashi; Ohnishi, Takayuki; Hara, Shigehiro; Anze, Hirohito; Hattori, Yoshiaki; Tamamushi, Shuichi; Bai, Shufeng; Wang, Jen-Shiang; Howell, Rafael; Chen, George; Li, Jiangwei; Tao, Jun; Wiley, Jim; Kurosawa, Terunobu; Saito, Yasuko; Takigawa, Tadahiro

2010-09-01

In electron beam writing on EUV mask, it has been reported that CD linearity does not show simple signatures as observed with conventional COG (Cr on Glass) masks because they are caused by scattered electrons form EUV mask itself which comprises stacked heavy metals and thick multi-layers. To resolve this issue, Mask Process Correction (MPC) will be ideally applicable. Every pattern is reshaped in MPC. Therefore, the number of shots would not increase and writing time will be kept within reasonable range. In this paper, MPC is extended to modeling for correction of CD linearity errors on EUV mask. And its effectiveness is verified with simulations and experiments through actual writing test.

Automatic alternative phase-shift mask CAD layout tool for gate shrinkage of embedded DRAM in logic below 0.18 μm

NASA Astrophysics Data System (ADS)

Ohnuma, Hidetoshi; Kawahira, Hiroichi

1998-09-01

An automatic alternative phase shift mask (PSM) pattern layout tool has been newly developed. This tool is dedicated for embedded DRAM in logic device to shrink gate line width with improving line width controllability in lithography process with a design rule below 0.18 micrometers by the KrF excimer laser exposure. The tool can crete Levenson type PSM used being coupled with a binary mask adopting a double exposure method for positive photo resist. By using graphs, this tool automatically creates alternative PSM patterns. Moreover, it does not give any phase conflicts. By adopting it to actual embedded DRAM in logic cells, we have provided 0.16 micrometers gate resist patterns at both random logic and DRAM areas. The patterns were fabricated using two masks with the double exposure method. Gate line width has been well controlled under a practical exposure-focus window.

Individual differences in metacontrast masking regarding sensitivity and response bias.

PubMed

Albrecht, Thorsten; Mattler, Uwe

2012-09-01

In metacontrast masking target visibility is modulated by the time until a masking stimulus appears. The effect of this temporal delay differs across participants in such a way that individual human observers' performance shows distinguishable types of masking functions which remain largely unchanged for months. Here we examined whether individual differences in masking functions depend on different response criteria in addition to differences in discrimination sensitivity. To this end we reanalyzed previously published data and conducted a new experiment for further data analyses. Our analyses demonstrate that a distinction of masking functions based on the type of masking stimulus is superior to a distinction based on the target-mask congruency. Individually different masking functions are based on individual differences in discrimination sensitivities and in response criteria. Results suggest that individual differences in metacontrast masking result from individually different criterion contents. Copyright © 2012 Elsevier Inc. All rights reserved.

What's in a mask? Information masking with forward and backward visual masks.

PubMed

Davis, Chris; Kim, Jeesun

2011-10-01

Three experiments tested how the physical format and information content of forward and backward masks affected the extent of visual pattern masking. This involved using different types of forward and backward masks with target discrimination measured by percentage correct in the first experiment (with a fixed target duration) and by an adaptive threshold procedure in the last two. The rationale behind the manipulation of the content of the masks stemmed from masking theories emphasizing attentional and/or conceptual factors rather than visual ones. Experiment 1 used word masks and showed that masking was reduced (a masking reduction effect) when the forward and backward masks were the same word (although in different case) compared to when the masks were different words. Experiment 2 tested the extent to which a reduction in masking might occur due to the physical similarity between the forward and backward masks by comparing the effect of the same content of the masks in the same versus different case. The result showed a significant reduction in masking for same content masks but no significant effect of case. The last experiment examined whether the reduction in masking effect would be observed with nonword masks--that is, having no high-level representation. No reduction in masking was found from same compared to different nonword masks (Experiment 3). These results support the view that the conscious perception of a rapidly displayed target stimulus is in part determined by high-level perceptual/cognitive factors concerned with masking stimulus grouping and attention.

Evaluation of a Teleform-based data collection system: a multi-center obesity research case study.

PubMed

Jenkins, Todd M; Wilson Boyce, Tawny; Akers, Rachel; Andringa, Jennifer; Liu, Yanhong; Miller, Rosemary; Powers, Carolyn; Ralph Buncher, C

2014-06-01

Utilizing electronic data capture (EDC) systems in data collection and management allows automated validation programs to preemptively identify and correct data errors. For our multi-center, prospective study we chose to use TeleForm, a paper-based data capture software that uses recognition technology to create case report forms (CRFs) with similar functionality to EDC, including custom scripts to identify entry errors. We quantified the accuracy of the optimized system through a data audit of CRFs and the study database, examining selected critical variables for all subjects in the study, as well as an audit of all variables for 25 randomly selected subjects. Overall we found 6.7 errors per 10,000 fields, with similar estimates for critical (6.9/10,000) and non-critical (6.5/10,000) variables-values that fall below the acceptable quality threshold of 50 errors per 10,000 established by the Society for Clinical Data Management. However, error rates were found to widely vary by type of data field, with the highest rate observed with open text fields. Copyright © 2014 Elsevier Ltd. All rights reserved.

Attentional capture by masked colour singletons.

PubMed

Ansorge, Ulrich; Horstmann, Gernot; Worschech, Franziska

2010-09-15

We tested under which conditions a colour singleton of which an observer is unaware captures attention. To prevent visual awareness of the colour singleton, we used backward masking. We find that a masked colour singleton cue captures attention if it matches the observer's goal to search for target colours but not if it is task-irrelevant. This is also reflected in event-related potentials to the visible target: the masked goal-matching cue elicits an attentional potential (N2pc) in a target search task. By contrast, a non-matching but equally strong masked colour singleton cue failed to elicit a capture effect and an N2pc. Results are discussed with regard to currently pertaining conceptions of attentional capture by colour singletons. Copyright 2010 Elsevier Ltd. All rights reserved.

Measurement Matrix Design for Phase Retrieval Based on Mutual Information

NASA Astrophysics Data System (ADS)

Shlezinger, Nir; Dabora, Ron; Eldar, Yonina C.

2018-01-01

In phase retrieval problems, a signal of interest (SOI) is reconstructed based on the magnitude of a linear transformation of the SOI observed with additive noise. The linear transform is typically referred to as a measurement matrix. Many works on phase retrieval assume that the measurement matrix is a random Gaussian matrix, which, in the noiseless scenario with sufficiently many measurements, guarantees invertability of the transformation between the SOI and the observations, up to an inherent phase ambiguity. However, in many practical applications, the measurement matrix corresponds to an underlying physical setup, and is therefore deterministic, possibly with structural constraints. In this work we study the design of deterministic measurement matrices, based on maximizing the mutual information between the SOI and the observations. We characterize necessary conditions for the optimality of a measurement matrix, and analytically obtain the optimal matrix in the low signal-to-noise ratio regime. Practical methods for designing general measurement matrices and masked Fourier measurements are proposed. Simulation tests demonstrate the performance gain achieved by the proposed techniques compared to random Gaussian measurements for various phase recovery algorithms.

Immunogenicity and safety of the new reduced-dose tetanus-diphtheria vaccine in healthy Korean adolescents: A comparative active control, double-blind, randomized, multicenter phase III study.

PubMed

Han, Seung Beom; Rhim, Jung-Woo; Shin, Hye Jo; Kim, Sang Yong; Kim, Jong-Hyun; Kim, Hyun-Hee; Lee, Kyung-Yil; Kim, Hwang Min; Choi, Young Youn; Ma, Sang Hyuk; Kim, Chun Soo; Kim, Dong Ho; Ahn, Dong Ho; Kang, Jin Han

2017-04-01

A new reduced-dose tetanus-diphtheria (Td) vaccine was developed in Korea, and phase I and II clinical trials were successfully undertaken. We conducted this double-blind, randomized, multicenter phase III clinical trial to assess the immunogenicity and safety of the new Td vaccine. Healthy adolescents 11-12 years of age were enrolled and randomized to receive the new Td vaccine (study group) or a commercially available Td vaccine (control group). Blood samples were collected prior to and 4 weeks after the vaccination. Between the study and control groups, seroprotection rate, booster response, and geometric mean titer of antibodies against diphtheria and tetanus toxoids were compared after the vaccination. All solicited and unsolicited adverse events and serious adverse events during the 6-week study period were monitored. A total of 164 adolescents received vaccination, and 156 of them were evaluated to assess immunogenicity. The seroprotection rate and geometric mean titer for antibodies against diphtheria were significantly higher in the study group, whereas those against tetanus were significantly higher in the control group. However, all seroprotection rates against diphtheria and tetanus in the study and control groups were high: 100% against diphtheria and tetanus in the study group, and 98.7% against diphtheria and 100% against tetanus in the control group. No significant differences in the frequency of solicited and unsolicited adverse events were observed between the two vaccine groups. The new Td vaccine is highly immunogenic and safe, and this new Td vaccine can be effectively used for preventing diphtheria and tetanus. Copyright © 2015. Published by Elsevier B.V.

Multicenter, randomized, open-label Phase II study comparing S-1 alternate-day oral therapy with the standard daily regimen as a first-line treatment in patients with unresectable advanced pancreatic cancer.

PubMed

Yamaue, Hiroki; Shimizu, Atsushi; Hagiwara, Yasuhiro; Sho, Masayuki; Yanagimoto, Hiroaki; Nakamori, Shoji; Ueno, Hideki; Ishii, Hiroshi; Kitano, Masayuki; Sugimori, Kazuya; Maguchi, Hiroyuki; Ohkawa, Shinichi; Imaoka, Hiroshi; Hashimoto, Daisuke; Ueda, Kazuki; Nebiki, Hiroko; Nagakawa, Tatsuya; Isayama, Hiroyuki; Yokota, Isao; Ohashi, Yasuo; Shirasaka, Tetsuhiko

2017-04-01

Non-inferiority for overall survival (OS) following alternate-day treatment with the oral anticancer drug S-1 compared with standard daily treatment was assessed in Japanese patients with unresectable advanced pancreatic cancer in a multicenter, randomized, phase II study. This trial was registered at the UMIN Clinical Trials Registry (no. 000008604). Chemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer were randomly assigned 2:1 to treatment with alternate-day (twice daily on alternate days from days 1 through 42 of a 42-day cycle) or daily (twice daily on days 1 through 28 of a 42-day cycle) treatment with S-1. The primary endpoint was OS. Secondary endpoints were progression-free survival (PFS), time to treatment failure, response rate, quality of life assessments, and safety. A total of 190 patients were enrolled, of which 185 were included in the final analysis (alternate-day: 121; daily: 64). Median OS was 9.4 for the alternate-day group and 10.4 months for the daily group [hazard ratio (HR), 1.19; 95% credible interval, 0.86 to 1.64], indicating that non-inferiority of alternate-day treatment to daily treatment was not demonstrated. Median PFS was 3.0 for the alternate-day group and 4.2 months for the daily group (HR, 1.65; 95% credible interval, 1.20-2.29). The incidence of anorexia, fatigue, neutrophils, pigmentation, and pneumonitis was lower in alternate-day treatment compared with daily treatment. S-1 for advanced pancreatic cancer should be taken daily as recommended, based on the decreased OS and PFS and marginal improvement in safety observed in the alternate-day group.

A randomized multicenter trial of Crotalidae polyvalent immune F(ab) antivenom for the treatment of rattlesnake envenomation in dogs.

PubMed

Peterson, Michael E; Matz, Michael; Seibold, Karen; Plunkett, Signe; Johnson, Scott; Fitzgerald, Kevin

2011-08-01

To determine clinical efficacy of the Crotalidae polyvalent immune F(ab) (ovine) antivenom (OPCA) against progressive crotalid envenomation in the dog as reflected in stabilization or improvement of snakebite severity scores (SSS). Additionally, due to the potential decreased half-life of the F(ab) antibodies in dogs we compared SSS between dogs receiving 2 different dosing regimes. Prospective, clinical trial. Five veterinary emergency and critical care facilities. One hundred and fifteen client-owned Crotalid (rattlesnake) snake bitten dogs in whom worsening of the envenomation syndrome was observed before OPCA treatment. In a multicenter randomized clinical trial a single dose (1 vial) of OPCA alone was compared with 2 doses (1/2 vial each) administered 6 hours apart. Standard supportive care was provided in all cases. Data were available for 115 patients, 9 of which were fatalities. All patients' clinical condition was documented with a standardized SSS system accounting for each major body system. Each fatality received maximum severity scores of 20. The mean severity score of the 115 patients decreased from 4.19 to 3.29 points and there was no difference between the 2 treatment groups. The mean severity score of the 107 patients without fatalities decreased from 4.16 to 2.15. Antivenin-related acute reactions occurred in 6 dogs (6%), and no serum sickness occurred within the 95 cases contacted at the 2-week posttreatment follow-up. In the first randomized trial in dogs of antivenin in the United States, OPCA effectively stabilized or terminated venom effects. There were no statistical differences detected between treatment groups within the study time frame. © Veterinary Emergency and Critical Care Society 2011.

The Norwegian Cervical Arthroplasty Trial (NORCAT): 2-year clinical outcome after single-level cervical arthroplasty versus fusion-a prospective, single-blinded, randomized, controlled multicenter study.

PubMed

Sundseth, Jarle; Fredriksli, Oddrun Anita; Kolstad, Frode; Johnsen, Lars Gunnar; Pripp, Are Hugo; Andresen, Hege; Myrseth, Erling; Müller, Kay; Nygaard, Øystein P; Zwart, John-Anker

2017-04-01

Standard surgical treatment for symptomatic cervical disc disease has been discectomy and fusion, but the use of arthroplasty, designed to preserve motion, has increased, and most studies report clinical outcome in its favor. Few of these trials, however, blinded the patients. We, therefore, conducted the Norwegian Cervical Arthroplasty Trial, and present 2-year clinical outcome after arthroplasty or fusion. This multicenter trial included 136 patients with single-level cervical disc disease. The patients were randomized to arthroplasty or fusion, and blinded to the treatment modality. The surgical team was blinded to randomization until nerve root decompression was completed. Primary outcome was the self-rated Neck Disability Index. Secondary outcomes were the numeric rating scale for pain and quality of life questionnaires Short Form-36 and EuroQol-5Dimension-3 Level. There was a significant improvement in the primary and all secondary outcomes from baseline to 2-year follow-up for both arthroplasty and fusion (P < 0.001), and no observed significant between-group differences at any follow-up times. However, linear mixed model analyses, correcting for baseline values, dropouts and missing data, revealed a difference in Neck Disability Index (P = 0.049), and arm pain (P = 0.027) in favor of fusion at 2 years. The duration of surgery was longer (P < 0.001), and the frequency of reoperations higher (P = 0.029) with arthroplasty. The present study showed excellent clinical results and no significant difference between treatments at any scheduled follow-up. However, the rate of index level reoperations was higher and the duration of surgery longer with arthroplasty. http://www.clinicaltrials.gov NCT 00735176.19.

Efficacy evaluation of a pollen blocker cream against dust-mite allergy: A multicenter, randomized, double-blind, placebo-controlled crossover trial.

PubMed

Li, Yanqing; Cheng, Lei; Chen, Xiaoning; Yang, Beibei; Wang, Dehui

2015-01-01

To further evaluate the efficacy and safety of a pollen blocker cream against dust-mite allergy. A multicenter, randomized, double-blind, placebo-controlled, crossover trial was conducted in a Chinese population. Patients diagnosed with perennial allergic rhinitis, sensitive to dust-mite allergy including Dermatophagoides farinae and Dermatophagoides pteronyssinus were randomly allocated to receive a pollen blocker cream or placebo, which was applied and spread evenly to the lower internal nose region three times daily for a total of 30 days. The primary outcome measurements for efficacy were total nasal symptom score (TNSS) and individual nasal symptom score (iNSS). Adverse events were also monitored. After application of a pollen blocker, the mean TNSS decreased from 23.1 to 13.8, the decrease of the pollen blocker group (9.3) was highly significant compared with the placebo group (5.2; p < 0.001). Similarly, the decreases in iNSSs (rhinorrhea, congestion, sneezing, and itching) between the pollen blocker group and the placebo group were also significant (p < 0.05). In addition, in adults, the pollen blocker led to a remarkably significant decrease in TNSS (9.5) compared with placebo (5.4; p < 0.001); in children, the pollen blocker led to a significant decrease in TNSS (8.6) compared with placebo (4.8; p < 0.05). No statistical difference was found in the incidence of adverse events between the two groups (p > 0.05), and no severe systematic reactions were observed. Pollen Blocker is a safe and effective alternative to the drugs for treatment of AR, especially for Chinese people allergic to dust-mite allergy.

Wing-shaped plastic stents vs. self-expandable metal stents for palliative drainage of malignant distal biliary obstruction: a randomized multicenter study.

PubMed

Schmidt, Arthur; Riecken, Bettina; Rische, Susanne; Klinger, Christoph; Jakobs, Ralf; Bechtler, Matthias; Kähler, Georg; Dormann, Arno; Caca, Karel

2015-05-01

Previous studies have shown superior patency rates for self-expandable metal stents (SEMS) compared with plastic stents in patients with malignant biliary obstruction. The aim of this study was to compare stent patency, patient survival, and complication rates between a newly designed, wing-shaped, plastic stent and SEMSs in patients with unresectable, malignant, distal, biliary obstruction. A randomized, multicenter trial was conducted at four tertiary care centers in Germany. A total of 37 patients underwent randomization between March 2010 and January 2013. Patients underwent endoscopic retrograde cholangiography with insertion of either a wing-shaped, plastic stent without lumen or an SEMS.  Stent failure occurred in 10/16 patients (62.5 %) in the winged-stent group vs. 4/18 patients (22.2 %) in the SEMS group (P = 0.034). The median time to stent failure was 51 days (range 2 - 92 days) for the winged stent and 80 days (range 28 - 266 days) for the SEMS (P = 0.002). Early stent failure (< 8 weeks after placement) occurred in 8 patients (50 %) vs. 2 patients (11.1 %), respectively (P = 0.022). After obtaining the results from this interim analysis, the study was discontinued because of safety concerns. The frequency of stent failure was significantly higher in the winged-stent group compared with the SEMS group. A high incidence of early stent failure within 8 weeks was observed in the winged-stent group. Thus, the winged, plastic stent without central lumen may not be appropriate for mid or long term drainage of malignant biliary obstruction. Study registration ClinicalTrials.gov (NCT01063634). © Georg Thieme Verlag KG Stuttgart · New York.

[The efficacy and safety of cefixime and amoxicillin/clavulanate in the treatment of asymptomatic bacteriuria in pregnant women: a randomized, prospective, multicenter study].

PubMed

Rafal'skiĭ, V V; Dovgan', E V; Kozyrev, Iu V; Gustovarova, T A; Khlybova, S V; Novoselova, A V; Filippenko, N G; Likhikh, D G

2013-01-01

The study was aimed to the evaluation of efficacy and safety of cefixime and amoxicillin/clavulanate in the treatment of asymptomatic bacteriuria in pregnant women. A prospective, multicenter, randomized study that included 112 pregnant women with asymptomatic bacteriuria was performed. 58 women were randomized in group 1 (cefixime [suprax solutab] 400 mg 1 time a day, 7 days), 54 women were included in group 2 (amoxicillin/clavulanate [amoksiklav] 625 mg 3 times a day, 7 days). The average age of the patients in group 1 was 25.2 +/- 6.6; in group 2--26.6 +/- 5.8 years. Physical examination, evaluation of complaints, collection of data on adverse reactions, and bacteriological analysis of urine were performed after enrollment in the study at visit 2 (day 10 +/- 1) and 3 (day 35 +/- 2). Comparable effectiveness of cefixime and amoxicillin/clavulanate in the treatment of asymptomatic bacteriuria in pregnant women was found. Eradication of the pathogen and sustained bacteriological response were observed in 94.8 and 92.7% of women treated with cefixime, and in 98.2 and 92.5% of women treated with amoxicillin/clavulanate, respectively (P > 0.05). At the same time, the use of amoxicillin/clavulanate compared with cefixime significantly higher was followed by the development of adverse reactions (13% and 1.7; respectively; P = 0.02). Seven-day courses of cefixime at a dose 400 mg 1 time a day and amoxicillin/clavulanate at a dose of 625 mg 3 times a day are high-effective treatment regimens for asymptomatic bacteriuria in pregnant women in Russia. The use of amoxicillin/clavulanate is significantly more often accompanied by the development of adverse reactions compared with cefixime.

Written pain neuroscience education in fibromyalgia: a multicenter randomized controlled trial.

PubMed

van Ittersum, Miriam W; van Wilgen, C Paul; van der Schans, Cees P; Lambrecht, Luc; Groothoff, Johan W; Nijs, Jo

2014-11-01

Mounting evidence supports the use of face-to-face pain neuroscience education for the treatment of chronic pain patients. This study aimed at examining whether written education about pain neuroscience improves illness perceptions, catastrophizing, and health status in patients with fibromyalgia. A double-blind, multicenter randomized controlled clinical trial with 6-month follow-up was conducted. Patients with FM (n = 114) that consented to participate were randomly allocated to receive either written pain neuroscience education or written relaxation training. Written pain neuroscience education comprised of a booklet with pain neuroscience education plus a telephone call to clarify any difficulties; the relaxation group received a booklet with relaxation education and a telephone call. The revised illness perception questionnaire, Pain Catastrophizing Scale, and fibromyalgia impact questionnaire were used as outcome measures. Both patients and assessors were blinded. Repeated-measures analyses with last observation carried forward principle were performed. Cohen's d effect sizes (ES) were calculated for all within-group changes and between-group differences. The results reveal that written pain neuroscience education does not change the impact of FM on daily life, catastrophizing, or perceived symptoms of patients with FM. Compared with written relaxation training, written pain neuroscience education improved beliefs in a chronic timeline of FM (P = 0.03; ES = 0.50), but it does not impact upon other domains of illness perceptions. Compared with written relaxation training, written pain neuroscience education slightly improved illness perceptions of patients with FM, but it did not impart clinically meaningful effects on pain, catastrophizing, or the impact of FM on daily life. Face-to-face sessions of pain neuroscience education are required to change inappropriate cognitions and perceived health in patients with FM. © 2013 World Institute of Pain.

Metacontrast masking is processed before grapheme-color synesthesia.

PubMed

Bacon, Michael Patrick; Bridgeman, Bruce; Ramachandran, Vilayanur S

2013-01-01

We investigated the physiological mechanism of grapheme-color synesthesia using metacontrast masking. A metacontrast target is rendered invisible by a mask that is delayed by about 60 ms; the target and mask do not overlap in space or time. Little masking occurs, however, if the target and mask are simultaneous. This effect must be cortical, because it can be obtained dichoptically. To compare the data for synesthetes and controls, we developed a metacontrast design in which nonsynesthete controls showed weaker dichromatic masking (i.e., the target and mask were in different colors) than monochromatic masking. We accomplished this with an equiluminant target, mask, and background for each observer. If synesthetic color affected metacontrast, synesthetes should show monochromatic masking more similar to the weak dichromatic masking among controls, because synesthetes could add their synesthetic color to the monochromatic condition. The target-mask pairs used for each synesthete were graphemes that elicited strong synesthetic colors. We found stronger monochromatic than dichromatic U-shaped metacontrast for both synesthetes and controls, with optimal masking at an asynchrony of 66 ms. The difference in performance between the monochromatic and dichromatic conditions in the synesthetes indicates that synesthesia occurs at a later processing stage than does metacontrast masking.

Design of the multicenter standardized supervised exercise training intervention for the claudication: exercise vs endoluminal revascularization (CLEVER) study.

PubMed

Bronas, Ulf G; Hirsch, Alan T; Murphy, Timothy; Badenhop, Dalynn; Collins, Tracie C; Ehrman, Jonathan K; Ershow, Abby G; Lewis, Beth; Treat-Jacobson, Diane J; Walsh, M Eileen; Oldenburg, Niki; Regensteiner, Judith G

2009-11-01

The CLaudication: Exercise Vs Endoluminal Revascularization (CLEVER) study is the first randomized, controlled, clinical, multicenter trial that is evaluating a supervised exercise program compared with revascularization procedures to treat claudication. In this report, the methods and dissemination techniques of the supervised exercise training intervention are described. A total of 217 participants are being recruited and randomized to one of three arms: (1) optimal medical care; (2) aortoiliac revascularization with stent; or (3) supervised exercise training. Of the enrolled patients, 84 will receive supervised exercise therapy. Supervised exercise will be administered according to a protocol designed by a central CLEVER exercise training committee based on validated methods previously used in single center randomized control trials. The protocol will be implemented at each site by an exercise committee member using training methods developed and standardized by the exercise training committee. The exercise training committee reviews progress and compliance with the protocol of each participant weekly. In conclusion, a multicenter approach to disseminate the supervised exercise training technique and to evaluate its efficacy, safety and cost-effectiveness for patients with claudication due to peripheral arterial disease (PAD) is being evaluated for the first time in CLEVER. The CLEVER study will further establish the role of supervised exercise training in the treatment of claudication resulting from PAD and provide standardized methods for use of supervised exercise training in future PAD clinical trials as well as in clinical practice.

Influence of total face, facial and nasal masks on short-term adverse effects during noninvasive ventilation.

PubMed

Holanda, Marcelo Alcantara; Reis, Ricardo Coelho; Winkeler, Georgia Freire Paiva; Fortaleza, Simone Castelo Branco; Lima, José Wellington de Oliveira; Pereira, Eanes Delgado Barros

2009-02-01

Failure of noninvasive ventilation (NIV) has been associated with short-term adverse effects related to the use of masks. The aim of this study was to compare the incidence, type and intensity of adverse effects, as well as the comfort, of total face masks (TFMs), facial masks (FMs) and nasal masks (NMs) during NIV. This was a randomized crossover trial involving 24 healthy volunteers submitted to six sessions of NIV in bilevel positive airway pressure mode using the TFM, FM and NM masks at low and moderate-to-high pressure levels. A written questionnaire was applied in order to evaluate eleven specific adverse effects related to the use of the masks. Comfort was assessed using a visual analog scale. The CO2 exhaled into the ventilator circuit was measured between the mask and the exhalation port. The performance of the TFM was similar to that of the NM and FM in terms of comfort scores. Higher pressure levels reduced comfort and increased adverse effects, regardless of the mask type. When the TFM was used, there were fewer air leaks and less pain at the nose bridge, although there was greater oronasal dryness and claustrophobia. Air leaks were most pronounced when the FM was used. The partial pressure of exhaled CO2 entering the ventilator circuit was zero for the TFM. The short-term adverse effects caused by NIV interfaces are related to mask type and pressure settings. The TFM is a reliable alternative to the NM and FM. Rebreathing of CO2 from the circuit is less likely to occur when a TFM is used.

What's in a title? An assessment of whether randomized controlled trial in a title means that it is one.

PubMed

Koletsi, Despina; Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

2012-06-01

In this study, we aimed to investigate whether studies published in orthodontic journals and titled as randomized clinical trials are truly randomized clinical trials. A second objective was to explore the association of journal type and other publication characteristics on correct classification. American Journal of Orthodontics and Dentofacial Orthopedics, European Journal of Orthodontics, Angle Orthodontist, Journal of Orthodontics, Orthodontics and Craniofacial Research, World Journal of Orthodontics, Australian Orthodontic Journal, and Journal of Orofacial Orthopedics were hand searched for clinical trials labeled in the title as randomized from 1979 to July 2011. The data were analyzed by using descriptive statistics, and univariable and multivariable examinations of statistical associations via ordinal logistic regression modeling (proportional odds model). One hundred twelve trials were identified. Of the included trials, 33 (29.5%) were randomized clinical trials, 52 (46.4%) had an unclear status, and 27 (24.1%) were not randomized clinical trials. In the multivariable analysis among the included journal types, year of publication, number of authors, multicenter trial, and involvement of statistician were significant predictors of correctly classifying a study as a randomized clinical trial vs unclear and not a randomized clinical trial. From 112 clinical trials in the orthodontic literature labeled as randomized clinical trials, only 29.5% were identified as randomized clinical trials based on clear descriptions of appropriate random number generation and allocation concealment. The type of journal, involvement of a statistician, multicenter trials, greater numbers of authors, and publication year were associated with correct clinical trial classification. This study indicates the need of clear and accurate reporting of clinical trials and the need for educating investigators on randomized clinical trial methodology. Copyright © 2012 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

Nasal versus face mask for multiple-breath washout technique in preterm infants.

PubMed

Schulzke, S M; Deeptha, K; Sinhal, S; Baldwin, D N; Pillow, J J

2008-09-01

The large dead space associated with face masks might impede the accuracy and feasibility of multiple-breath washout (MBW) measurements in small infants. We asked if a low dead space nasal mask would provide measurements of resting lung volume and ventilation inhomogeneity comparable to those obtained with a face mask, when using the MBW technique. Unsedated preterm infants breathing without mechanical assistance and weighing between 1.50 and 2.49 kg were studied. Paired MBW tests with nasal and face masks were obtained using sulphur hexafluoride (SF(6)) as the tracer gas. The order of mask application was quasi-randomized. Bland-Altman method and intraclass correlation coefficient were used to analyze outcomes. Measurements were obtained in 20 infants with a mean (SD) postmenstrual age of 36 (1.4) w and a test weight of 2.0 (0.3) kg. The mean difference (95% CI) for nasal vs. face mask was -3.2 breaths/min (-6.2, -0.1 breaths/min) for respiratory rate, -1.0 ml/kg (-2.3, 0.3 ml/kg) for lung volume, 0.6 (0.1, 1.1) for lung clearance index, 0.2 (0.1, 0.3) for first to zeroeth moment ratio and 1.33 (0.6, 2.4) for second to zeroeth moment ratio. Paired measurements of lung volume showed acceptable agreement and good correlation, but there was poor agreement and poor correlation between indices of ventilation inhomogeneity obtained with the two masks. Functional dead space of the nasal mask was similar to that of the face mask despite its smaller water displacement volume. During MBW in infants below 2.5 kg body weight, a nasal mask results in comparable lung volume measurements. Indices of ventilation inhomogeneity may not be directly comparable using masks with different dead space. (c) 2008 Wiley-Liss, Inc.

Efficacy of a heat exchanger mask in cold exercise-induced asthma.

PubMed

Beuther, David A; Martin, Richard J

2006-05-01

To determine the efficacy of a novel mask device in limiting cold air exercise-induced decline in lung function in subjects with a history of exercise-induced asthma (EIA). In spite of appropriate medical therapy, many asthma patients are limited in cold weather activities. In study 1, 13 asthmatic subjects performed two randomized, single-blind treadmill exercise tests while breathing cold air (- 25 to - 15 degrees C) through a placebo or active heat exchanger mask. In study 2, five subjects with EIA performed three treadmill exercise tests while breathing cold air: one test using the heat exchanger mask, one test without the mask but with albuterol pretreatment, and one test with neither the mask nor albuterol pretreatment (unprotected exercise). For all studies, spirometry was performed before and at 5, 15, and 30 min after exercise challenge. For both studies, a total of 15 subjects with a history of asthma symptoms during cold air exercise were recruited. In study 1, the mean decrease (+/- SE) in FEV1 was 19 +/- 4.9% with placebo, and 4.3 +/- 1.6% with the active device (p = 0.0002). The mean decrease in maximum mid-expiratory flow (FEF(25-75)) was 31 +/- 5.7% with placebo and 4.7 +/- 1.7% with the active device (p = 0.0002). In study 2, the mean decrease in FEV1 was 6.3 +/- 3.9%, 11 +/- 3.7%, and 28 +/- 10% for the heat exchanger mask, albuterol pretreatment, and unprotected exercises, respectively (p = 0.4375 for mask vs albuterol, p = 0.0625 for mask vs unprotected exercise). The mean decrease in FEF(25-75) was 10 +/- 4.8%, 23 +/- 6.0%, and 36 +/- 11%, respectively (p = 0.0625 for mask vs albuterol, p = 0.0625 for mask vs unprotected exercise). This heat exchanger mask blocks cold exercise-induced decline in lung function at least as effectively as albuterol pretreatment.

Inclusion and definition of acute renal dysfunction in critically ill patients in randomized controlled trials: a systematic review.

PubMed

da Hora Passos, Rogerio; Ramos, Joao Gabriel Rosa; Gobatto, André; Caldas, Juliana; Macedo, Etienne; Batista, Paulo Benigno

2018-04-24

In evidence-based medicine, multicenter, prospective, randomized controlled trials (RCTs) are the gold standard for evaluating treatment benefits and ensuring the effectiveness of interventions. Patient-centered outcomes, such as mortality, are most often the preferred evaluated outcomes. While there is currently agreement on how to classify renal dysfunction in critically ill patients , the application frequency of this new classification system in RCTs has not previously been evaluated. In this study, we aim to assess the definition of renal dysfunction in multicenter RCTs involving critically ill patients that included mortality as a primary endpoint. A comprehensive search was conducted for publications reporting multicenter randomized controlled trials (RCTs) involving adult patients in intensive care units (ICUs) that included mortality as a primary outcome. MEDLINE and PUBMED were queried for relevant articles in core clinical journals published between May 2004 and December 2017. Of 418 articles reviewed, 46 multicenter RCTs with a primary endpoint related to mortality were included. Thirty-six (78.3%) of the trial reports provided information on renal function in the participants. Only seven articles (15.2%) included mean or median serum creatinine levels, mean creatinine clearance or estimated glomerular filtration rates. Sequential organ failure assessment (SOFA) score was the most commonly used definition of renal dysfunction (20 studies; 43.5%). Risk, Injury, Failure, Loss, End-stage renal disease (RIFLE), Acute Kidney Injury Network (AKIN) and Kidney Disease Improving Global Outcomes (KDIGO) criteria were used in five (10.9%) trials. In thirteen trials (28.3%), no renal dysfunction criteria were reported. Only one trial excluded patients with renal dysfunction, and it used urinary output or need for renal replacement therapy (RRT) as criteria for this diagnosis. The presence of renal dysfunction was included as a baseline patient characteristic in most RCTs. The RIFLE, AKIN and KDIGO classification systems were infrequently used; renal dysfunction was generally defined using the SOFA score.

Continuous positive airway pressure and ventilation are more effective with a nasal mask than a full face mask in unconscious subjects: a randomized controlled trial.

PubMed

Oto, Jun; Li, Qian; Kimball, William R; Wang, Jingping; Sabouri, Abdolnabi S; Harrell, Priscilla G; Kacmarek, Robert M; Jiang, Yandong

2013-12-23

Upper airway obstruction (UAO) is a major problem in unconscious subjects, making full face mask ventilation difficult. The mechanism of UAO in unconscious subjects shares many similarities with that of obstructive sleep apnea (OSA), especially the hypotonic upper airway seen during rapid eye movement sleep. Continuous positive airway pressure (CPAP) via nasal mask is more effective at maintaining airway patency than a full face mask in patients with OSA. We hypothesized that CPAP via nasal mask and ventilation (nCPAP) would be more effective than full face mask CPAP and ventilation (FmCPAP) for unconscious subjects, and we tested our hypothesis during induction of general anesthesia for elective surgery. In total, 73 adult subjects requiring general anesthesia were randomly assigned to one of four groups: nCPAP P0, nCPAP P5, FmCPAP P0, and FmCPAP P5, where P0 and P5 represent positive end-expiratory pressure (PEEP) 0 and 5 cm H2O applied prior to induction. After apnea, ventilation was initiated with pressure control ventilation at a peak inspiratory pressure over PEEP (PIP/PEEP) of 20/0, then 20/5, and finally 20/10 cm H2O, each applied for 1 min. At each pressure setting, expired tidal volume (Vte) was calculated by using a plethysmograph device. The rate of effective tidal volume (Vte > estimated anatomical dead space) was higher (87.9% vs. 21.9%; P<0.01) and the median Vte was larger (6.9 vs. 0 mL/kg; P<0.01) with nCPAP than with FmCPAP. Application of CPAP prior to induction of general anesthesia did not affect Vte in either approach (nCPAP pre- vs. post-; 7.9 vs. 5.8 mL/kg, P = 0.07) (FmCPAP pre- vs. post-; 0 vs. 0 mL/kg, P = 0.11). nCPAP produced more effective tidal volume than FmCPAP in unconscious subjects. ClinicalTrials.gov identifier: NCT01524614.

A 12-week randomized, double-blind, placebo-controlled multicenter study of choline-stabilized orthosilicic acid in patients with symptomatic knee osteoarthritis.

PubMed

Geusens, Piet; Pavelka, Karel; Rovensky, Jozef; Vanhoof, Johan; Demeester, Nathalie; Calomme, Mario; Vanden Berghe, Dirk

2017-01-05

The aim of this study was to assess the efficacy of choline-stabilized orthosilicic acid (ch-OSA) in patients with symptomatic knee osteoarthritis (OA). In a multicenter, double-blind, placebo-controlled study, 211 patients with knee OA (Kellgren and Lawrence grade II or III) and moderate to moderately severe pain were randomly allocated to ch-OSA or placebo for 12 weeks. The primary outcome was the change in the WOMAC pain subscale from baseline to week 12. Secondary outcomes were changes from baseline to week 12 in WOMAC total, WOMAC stiffness, WOMAC physical function, Subject Global Assessment and levels of cartilage degradation biomarkers C-terminal telopeptide of collagen type II (CTX-II) and cartilage oligomeric matrix protein (COMP). Pre-specified subgroup analyses included the effect of gender. A total of 166 (120 women, 46 men) patients were included in the analysis (87 and 79 in the ch-OSA and placebo group, respectively). In the total study population, no differences were observed between the two treatment groups for the different outcomes but significant treatment x gender interactions were found. In men taking ch-OSA, a significant improvement in WOMAC total, WOMAC stiffness and WOMAC physical function as well as a lower increase in biomarker levels of cartilage degradation was observed, but not in women. The change in WOMAC pain showed a similar positive trend in men taking ch-OSA. After 12 weeks of treatment, no effect was found of ch-OSA in the total study population on clinical parameters and biomarkers, but a gender interaction was observed. In men, ch-OSA was found effective in reducing symptoms of knee OA, which was associated with a slight but significant reduction of biomarkers that are related to cartilage degradation. The study was registered retrospectively: ISRCTN88583133 . Registration date: 2015-10-07.

Application of a nanotechnology antimicrobial spray to prevent lower urinary tract infection: a multicenter urology trial

PubMed Central

2012-01-01

Background Catheter-associated urinary tract infection (CAUTI) is a common nosocomial device-associated infection. It is now recognized that the high infection rates were caused by the formation of biofilm on the surface of the catheters that decreases the susceptibility to antibiotics and results in anti-microbial resistance. In this study, we performed an in vitro test to explore the mechanism of biofilm formation and subsequently conducted a multi-center clinical trial to investigate the efficacy of CAUTI prevention with the application of JUC, a nanotechnology antimicrobial spray. Methods Siliconized latex urinary catheters were cut into fragments and sterilized by autoclaving. The sterilized sample fragments were randomly divided into the therapy and control group, whereby they were sprayed with JUC and distilled water respectively and dried before use. The experimental standard strains of Escherichia coli (E. coli) were isolated from the urine samples of patients. At 16 hours and 7 days of incubation, the samples were extracted for confocal laser scanning microscopy. A total of 1,150 patients were accrued in the clinical study. Patients were randomized according to the order of surgical treatment. The odd array of patients was assigned as the therapy group (JUC), and the even array of patients was assigned as the control group (normal saline). Results After 16 hours of culture, bacterial biofilm formed on the surface of sample fragments from the control group. In the therapy group, no bacterial biofilm formation was observed on the sample fragments. No significant increase in bacterial colony count was observed in the therapy group after 7 days of incubation. On the 7th day of catheterization, urine samples were collected for bacterial culture before extubation. Significant difference was observed in the incidence of bacteriuria between the therapy group and control group (4.52% vs. 13.04%, p < 0.001). Conclusions In this study, the effectiveness of JUC in preventing CAUTI in a hospital setting was demonstrated in both in vitro and clinical studies. PMID:23046566

Effects of a Psychological Intervention in a Primary Health Care Center for Caregivers of Dependent Relatives: A Randomized Trial

ERIC Educational Resources Information Center

Rodriguez-Sanchez, Emiliano; Patino-Alonso, Maria C.; Mora-Simon, Sara; Gomez-Marcos, Manuel A.; Perez-Penaranda, Anibal; Losada-Baltar, Andres; Garcia-Ortiz, Luis

2013-01-01

Purpose: To assess, in the context of Primary Health Care (PHC), the effect of a psychological intervention in mental health among caregivers (CGs) of dependent relatives. Design and Methods: Randomized multicenter, controlled clinical trial. The 125 CGs included in the trial were receiving health care in PHC. Inclusion criteria: Identifying…

A Multicenter, Randomized Clinical Trial of a Cognitive Remediation Program for Childhood Survivors of a Pediatric Malignancy

ERIC Educational Resources Information Center

Butler, Robert W.; Copeland, Donna R.; Fairclough, Diane L.; Mulhern, Raymond K.; Katz, Ernest R.; Kazak, Anne E.; Noll, Robert B.; Patel, Sunita K.; Sahler, Olle Jane Z.

2008-01-01

Survivors of childhood cancer whose malignancy and/or treatment involved the central nervous system may demonstrate a consistent pattern of neurocognitive deficits. The present study evaluated a randomized clinical trial of the Cognitive Remediation Program (CRP). Participants were 6- to 17-year-old survivors of childhood cancer (N = 161; 35%…

Safety and Efficacy of ABT-089 in Pediatric Attention-Deficit/Hyperactivity Disorder: Results from Two Randomized Placebo-Controlled Clinical Trials

ERIC Educational Resources Information Center

Wilens, Timothy E.; Gault, Laura M.; Childress, Ann; Kratochvil, Christopher J.; Bensman, Lindsey; Hall, Coleen M.; Olson, Evelyn; Robieson, Weining Z.; Garimella, Tushar S.; Abi-Saab, Walid M.; Apostol, George; Saltarelli, Mario D.

2011-01-01

Objective: To assess the safety and efficacy of ABT-089, a novel alpha[subscript 4]beta[subscript 2] neuronal nicotinic receptor partial agonist, vs. placebo in children with attention-deficit/hyperactivity disorder (ADHD). Method: Two multicenter, randomized, double-blind, placebo-controlled, parallel-group studies of children 6 through 12 years…

Effect of Levosimendan on Renal Outcome in Cardiac Surgery Patients With Chronic Kidney Disease and Perioperative Cardiovascular Dysfunction: A Substudy of a Multicenter Randomized Trial.

PubMed

Zangrillo, Alberto; Alvaro, Gabriele; Belletti, Alessandro; Pisano, Antonio; Brazzi, Luca; Calabrò, Maria G; Guarracino, Fabio; Bove, Tiziana; Grigoryev, Evgeny V; Monaco, Fabrizio; Boboshko, Vladimir A; Likhvantsev, Valery V; Scandroglio, Anna M; Paternoster, Gianluca; Lembo, Rosalba; Frassoni, Samuele; Comis, Marco; Pasyuga, Vadim V; Navalesi, Paolo; Lomivorotov, Vladimir V

2018-02-26

Acute kidney injury (AKI) occurs frequently after cardiac surgery. Levosimendan might reduce the incidence of AKI in patients undergoing cardiac surgery. The authors investigated whether levosimendan administration could reduce AKI incidence in a high-risk cardiac surgical population. Post hoc analysis of a multicenter randomized trial. Cardiac surgery operating rooms and intensive care units of 14 centers in 3 countries. The study comprised 90 patients who underwent mitral valve surgery with an estimated glomerular filtration rate <60 mL/min/1.73 m 2 and perioperative myocardial dysfunction. Patients were assigned randomly to receive levosimendan (0.025-0.2 μg/kg/min) or placebo in addition to standard inotropic treatment. Forty-six patients were assigned to receive levosimendan and 44 to receive placebo. Postoperative AKI occurred in 14 (30%) patients in the levosimendan group versus 23 (52%) in the placebo group (absolute difference -21.8; 95% confidence interval -41.7 to -1.97; p = 0.035). The incidence of major complications also was lower (18 [39%]) in the levosimendan group versus that in the placebo group (29 [66%]) (absolute difference -26.8 [-46.7 to -6.90]; p = 0.011). A trend toward lower serum creatinine at intensive care unit discharge was observed in the levosimendan group (1.18 [0.99-1.49] mg/dL) versus that in the placebo group (1.39 [1.05-1.76] mg/dL) (95% confidence interval -0.23 [-0.49 to 0.01]; p = 0.07). Levosimendan may improve renal outcome in cardiac surgery patients with chronic kidney disease undergoing mitral valve surgery who develop perioperative myocardial dysfunction. Results of this exploratory analysis should be investigated in future properly designed randomized controlled trials. Copyright © 2018 Elsevier Inc. All rights reserved.

The South Asian cataract management study: complications, vision outcomes, and corneal endothelial cell loss in a randomized multicenter clinical trial comparing intracapsular cataract extraction with and without anterior chamber intraocular lens implantation.

PubMed

Snellingen, T; Shrestha, J K; Huq, F; Husain, R; Koirala, S; Rao, G N; Pokhrel, R P; Kolstad, A; Upadhyay, M P; Apple, D J; Arnesen, E; Cheng, H; Olsen, E G; Vogel, M

2000-02-01

To determine clinical outcomes of primary intracapsular cataract surgery with and without implantation of anterior chamber lenses. A multicenter randomized clinical trial. One thousand two hundred twenty-nine male and female patients 40-75 years of age with senile cataract. Study patients were recruited from screening eye camps and outpatient clinics. Randomization to the two treatment groups was performed after screening for predetermined inclusion and exclusion criteria. Demographics, visual acuity, intraocular pressures, and corneal endothelial cell data were recorded before surgery and at 6 weeks, 12 months, and 24 months after surgery. Monitoring of the study was secured by a standardized image documentation procedure on all patients using the IMAGEnet digital imaging system. Analysis of corneal endothelial cell images was performed with the Cell Soft software (Topcon Corporation, Japan). Visual acuity and central corneal endothelial cell loss. The patients were randomized to intraocular lens (IOL; n = 616) and no IOL (n = 613) implantation. Surgical complications were reported in 177 (14.4%) patients (IOL = 14.8%; no IOL = 14.0%). The most frequent complication observed was vitreous loss which occurred in 10.3% of eyes (IOL = 11.2%; no IOL = 9.5%). At the final examination (2 years after surgery), 88% of the operated eyes had a best corrected vision of 6/18 or better (IOL = 88.8%; no IOL = 86.6%). Analysis of corneal endothelial cell data showed a small but significantly greater cell loss 6 weeks after surgery in eyes with IOL compared with those without IOL, but no overall difference was found between the treatment groups in the long term follow-up. The findings indicate that there is a rationale for the use of anterior chamber intraocular lenses in primary intracapsular cataract surgery.

Protocolized fluid therapy in brain-dead donors: The multi-center randomized MOnIToR trial

PubMed Central

Al-Khafaji, Ali; Elder, Michele; Lebovitz, Daniel J; Murugan, Raghavan; Souter, Michael; Stuart, Susan; Wahed, Abdus S.; Keebler, Ben; Dils, Dorrie; Mitchell, Stephanie; Shutterly, Kurt; Wilkerson, Dawn; Pearse, Rupert; Kellum, John A

2015-01-01

BACKGROUND Critical shortages of organs for transplantation jeopardize many lives. Observational data suggest that better fluid management for deceased organ donors could increase organ recovery. We conducted the first large multi-center randomized trial in brain-dead donors to determine whether protocolized fluid therapy increases organs transplanted. METHODS We randomly assigned donors to either protocolized or usual care in eight organ procurement organizations. A “protocol-guided fluid therapy” algorithm targeting cardiac index, mean arterial pressure and pulse pressure variation was used. Our primary outcome was the number of organs transplanted per donor and our primary analysis was intention-to-treat. Secondary analyses included: 1) modified intention-to-treat where only subjects able to receive the intervention were included, and 2) twelve-month survival in transplant recipients. The study was stopped early. RESULTS We enrolled 556 donors; 279 protocolized care, 277 usual care. Groups had similar characteristics at baseline. The study protocol could be implemented in 76% of subjects randomized to the intervention. There was no significant difference in mean number of organs transplanted per donor: 3.39 organs per donor, (95%CI: 3.14-3.63) with protocolized care, compared to usual care 3.29 (95%CI: 3.04-3.54) (mean difference, 0.1, 95%CI: -0.25 to 0.45; p=0.56). In modified intention-to-treat analysis the mean number of organs increased (3.52 organs per donor, 95%CI: 3.23-3.8) but was not statistically significant (mean difference, 0.23, 95%CI: -0.15-0.61; p=0.23). Among the 1430 recipients of organs from study subjects, with data available, 56 deaths (7.8%) occurred in the protocolized care arm and 56 (7.9%) in the usual care arm in the first year (Hazard Ratio: 0.97, p=0.86). CONCLUSIONS In brain-dead organ donors, protocol-guided fluid therapy compared to usual care may not increase the number of organs transplanted per donor. PMID:25583616

Creation of hybrid optoelectronic systems for document identification

NASA Astrophysics Data System (ADS)

Muravsky, Leonid I.; Voronyak, Taras I.; Kulynych, Yaroslav P.; Maksymenko, Olexander P.; Pogan, Ignat Y.

2001-06-01

Use of security devices based on a joint transform correlator (JTC) architecture for identification of credit cards and other products is very promising. The experimental demonstration of the random phase encoding technique for security verification shows that hybrid JTCs can be successfully utilized. The random phase encoding technique provides a very high protection level of products and things to be identified. However, the realization of this technique is connected with overcoming of the certain practical problems. To solve some of these problems and simultaneously to improve the security of documents and other products, we propose to use a transformed phase mask (TPM) as an input object in an optical correlator. This mask is synthesized from a random binary pattern (RBP), which is directly used to fabricate a reference phase mask (RPM). To obtain the TPM, we previously separate the RBP on a several parts (for example, K parts) of an arbitrary shape and further fabricate the TPM from this transformed RBP. The fabricated TPM can be bonded as the optical mark to any product or thing to be identified. If the RPM and the TPM are placed on the optical correlator input, the first diffracted order of the output correlation signal is containing the K narrow autocorrelation peaks. The distances between the peaks and the peak's intensities can be treated as the terms of the identification feature vector (FV) for the TPM identification.

Coded aperture ptychography: uniqueness and reconstruction

NASA Astrophysics Data System (ADS)

Chen, Pengwen; Fannjiang, Albert

2018-02-01

Uniqueness of solution is proved for any ptychographic scheme with a random mask under a minimum overlap condition and local geometric convergence analysis is given for the alternating projection (AP) and Douglas-Rachford (DR) algorithms. DR is shown to possess a unique fixed point in the object domain and for AP a simple criterion for distinguishing the true solution among possibly many fixed points is given. A minimalist scheme, where the adjacent masks overlap 50% of the area and each pixel of the object is illuminated by exactly four illuminations, is conveniently parametrized by the number q of shifted masks in each direction. The lower bound 1  -  C/q 2 is proved for the geometric convergence rate of the minimalist scheme, predicting a poor performance with large q which is confirmed by numerical experiments. The twin-image ambiguity is shown to arise for certain Fresnel masks and degrade the performance of reconstruction. Extensive numerical experiments are performed to explore the general features of a well-performing mask, the optimal value of q and the robustness with respect to measurement noise.

A face versus non-face context influences amygdala responses to masked fearful eye whites.

PubMed

Kim, M Justin; Solomon, Kimberly M; Neta, Maital; Davis, F Caroline; Oler, Jonathan A; Mazzulla, Emily C; Whalen, Paul J

2016-12-01

The structure of the mask stimulus is crucial in backward masking studies and we recently demonstrated such an effect when masking faces. Specifically, we showed that activity of the amygdala is increased to fearful facial expressions masked with neutral faces and decreased to fearful expressions masked with a pattern mask-but critically both masked conditions discriminated fearful expressions from happy expressions. Given this finding, we sought to test whether masked fearful eye whites would produce a similar profile of amygdala response in a face vs non-face context. During functional magnetic resonance imaging scanning sessions, 30 participants viewed fearful or happy eye whites masked with either neutral faces or pattern images. Results indicated amygdala activity was increased to fearful vs happy eye whites in the face mask condition, but decreased to fearful vs happy eye whites in the pattern mask condition-effectively replicating and expanding our previous report. Our data support the idea that the amygdala is responsive to fearful eye whites, but that the nature of this activity observed in a backward masking design depends on the mask stimulus. © The Author (2016). Published by Oxford University Press.

Cuing effects for informational masking

NASA Astrophysics Data System (ADS)

Richards, Virginia M.; Neff, Donna L.

2004-01-01

The detection of a tone added to a random-frequency, multitone masker can be very poor even when the maskers have little energy in the frequency region of the signal. This paper examines the effects of adding a pretrial cue to reduce uncertainty for the masker or the signal. The first two experiments examined the effect of cuing a fixed-frequency signal as the number of masker components and presentation methods were manipulated. Cue effectiveness varied across observers, but could reduce thresholds by as much as 20 dB. Procedural comparisons indicated observers benefited more from having two masker samples to compare, with or without a signal cue, than having a single interval with one masker sample and a signal cue. The third experiment used random-frequency signals and compared no-cue, signal-cue, and masker-cue conditions, and also systematically varied the time interval between cue offset and trial onset. Thresholds with a cued random-frequency signal remained higher than for a cued fixed-frequency signal. For time intervals between the cue and trial of 50 ms or longer, thresholds were approximately the same with a signal or a masker cue and lower than when there was no cue. Without a cue or with a masker cue, analyses of possible decision strategies suggested observers attended to the potential signal frequencies, particularly the highest signal frequency. With a signal cue, observers appeared to attend to the frequency of the subsequent signal.

Treatment of dry eye syndrome with orally administered CF101: data from a phase 2 clinical trial.

PubMed

Avni, Isaac; Garzozi, Hanna J; Barequet, Irina S; Segev, Fanni; Varssano, David; Sartani, Gil; Chetrit, Noa; Bakshi, Erez; Zadok, David; Tomkins, Oren; Litvin, Gilad; Jacobson, Kenneth A; Fishman, Sari; Harpaz, Zivit; Farbstein, Motti; Yehuda, Sara Bar; Silverman, Michael H; Kerns, William D; Bristol, David R; Cohn, Ilan; Fishman, Pnina

2010-07-01

To explore the safety and efficacy of CF101, an A(3) adenosine receptor agonist, in patients with moderate to severe dry eye syndrome. Phase 2, multicenter, randomized, double-masked, placebo-controlled, parallel-group study. Sixty-eight patients completed the study, 35 patients in the placebo group and 33 patients in the CF101 group. Patients were treated orally with either 1 mg CF101 pills or matching vehicle-filled placebo pills, given twice daily for 12 weeks, followed by a 2-week posttreatment observation. An improvement of more than 25% over baseline at week 12 in one of the following parameters: (1) tear break-up time (BUT); (2) superficial punctate keratitis assessed by fluorescein staining results; and (3) Schirmer tear test 1 results. Clinical laboratory safety tests, ophthalmic examinations, intraocular pressure (IOP) measurements, electrocardiographic evaluations, vital sign measurements, and monitoring of adverse events. A statistically significant increase in the proportion of patients who achieved more than 25% improvement in the corneal staining and in the clearance of corneal staining was noted between the CF101-treated group and the placebo group. Treatment with CF101 resulted in a statistically significant improvement in the mean change from baseline at week 12 of the corneal staining, BUT, and tear meniscus (TM) height in the CF101-treated group. CF101 was well tolerated and exhibited an excellent safety profile with no serious adverse events. A statistically significant decrease from baseline was observed in the IOP of the CF101-treated group in comparison with the placebo group. CF101, given orally, induced a statistically significant improvement in the corneal staining and an improvement in the BUT and TM in patients with moderate to severe dry eye syndrome. The drug was very well tolerated. These data and the anti-inflammatory characteristic of CF101 support further study of the drug as a potential treatment for the signs and symptoms of dry eye syndrome. Proprietary or commercial disclosure may be found after the references. Copyright 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Treatment of Dry Eye Syndrome with Orally Administered CF101: Data from a Phase 2 Clinical Trial

PubMed Central

Avni, Isaac; Garzozi, Hanna J.; Barequet, Irina S.; Segev, Fanni; Varssano, David; Sartani, Gil; Chetrit, Noa; Bakshi, Erez; Zadok, David; Tomkins, Oren; Litvin, Gilad; Jacobson, Kenneth A.; Fishman, Sari; Harpaz, Zivit; Farbstein, Motti; Bar Yehuda, Sara; Silverman, Michael H.; Kerns, William D.; Bristol, David R.; Cohn, Ilan; Fishman, Pnina

2013-01-01

Objective To explore the safety and efficacy of CF101, an A3 adenosine receptor agonist, in patients with moderate-to-severe dry eye syndrome Design Phase 2, multicenter, randomized, double-masked, placebo-controlled, parallel-group study. Participants 68 patients completed the study, 35 patients in the placebo group and 33 patients in the CF101 group. Intervention Patients were orally treated with either 1 mg CF101 pills or matching vehicle-filled placebo pills, given twice daily for 12 weeks, followed by a 2-week post-treatment observation. Main Outcome Measures Efficacy an improvement of >25% over baseline at week 12 in one of the following parameters: (a) tear break-up time (BUT); (b) superficial punctate keratitis assessed by fluorescein staining (FS); (c) Schirmer tear test 1 (ST1). Safety clinical laboratory safety tests, ophthalmic examinations, intraocular pressure (IOP) measurements, electrocardiographic evaluations, vital sign measurements and monitoring of adverse events. Results A statistically significant increase in the proportion of patients who achieved more than 25% improvement in the corneal staining and in the clearance of corneal staining was noted between the CF101-treated group and the placebo group. Treatment with CF101 resulted in a statistically significant improvement in the mean change from baseline at week 12 of the corneal staining, BUT, and tear meniscus (TM) height in the CF101-treated group CF101 was well tolerated and exhibited an excellent safety profile with no serious adverse events. A statistically significant decrease from baseline was observed in the IOP of the CF101-treated group in comparison with the placebo group. Conclusions CF101, given orally, induced a statistically significant improvement in the corneal staining and an improvement in the BUT and TM in patients with moderate-to-severe dry eye syndrome. The drug was very well tolerated. These data and the anti-inflammatory characteristic of CF101 support further study of the drug as a potential treatment for the signs and symptoms of dry eye syndrome. PMID:20304499

The effectiveness of nasal mask vs face mask ventilation in anesthetized, apneic pediatric subjects over 2 years of age: a randomized controlled trial.

PubMed

Itagaki, Taiga; Gubin, Tatyana A; Sayal, Puneet; Jiang, Yandong; Kacmarek, Robert M; Anderson, Thomas Anthony

2016-02-01

We hypothesized that anesthetized, apneic children could be ventilated equivalently or more efficiently by nasal mask ventilation (NMV) than face mask ventilation (FMV). The aim of this randomized controlled study was to test this hypothesis by comparing the expiratory tidal volume (Vte) between NMV and FMV. After the induction of anesthesia, 41 subjects, 3-17 years of age without anticipated difficult mask ventilation, were randomly assigned to receive either NMV or FMV with neck extension. Both groups were ventilated with pressure control ventilation (PCV) at 20 cmH2 O of peak inspiratory pressure (PIP) with positive end-expiratory pressure (PEEP) levels of 0, 5, and 10 cmH2 O. An additional mouth closing maneuver (MCM) was applied for the NMV group. The Vte was higher in the FMV group compared with the NMV group (median difference [95% CI]: 8.4 [5.5-11.6] ml·kg(-1) ; P < 0.001) when MCM was not applied. NMV achieved less PEEP than FMV (median difference [95% CI]: 5.0 [4.3-5.3] cmH2 O at 10 cmH2 O; P < 0.001) though both groups achieved the set PIP level. In the NMV group, MCM markedly increased Vte (median increase [95% CI]: 5.9 [2.5-9.0] ml·kg(-1) ; P < 0.005) and PEEP (median increase [95% CI]: 5.0 [0.6-8.6] cmH2 O at 10 cmH2 O; P < 0.005); however, PEEP was highly variable and lower than that of FMV (median difference [95% CI]: 2.5 [0.8-8.5] cmH2 O at 10 cmH2 O; P < 0.05). In anesthetized, apneic children greater than 2 years of age ventilated with an anesthesia ventilator and neck extension, FMV established a greater Vte than NMV regardless of mouth status. NMV could not maintain the set PEEP level due to an air leak from the mouth. The MCM increased the Vte and PEEP. © 2016 John Wiley & Sons Ltd.

Voice Quality After a Semi-Occluded Vocal Tract Exercise With a Ventilation Mask in Contemporary Commercial Singers: Acoustic Analysis and Self-Assessments.

PubMed

Fantini, Marco; Succo, Giovanni; Crosetti, Erika; Borragán Torre, Alfonso; Demo, Roberto; Fussi, Franco

2017-05-01

The current study aimed at investigating the immediate effects of a semi-occluded vocal tract exercise with a ventilation mask in a group of contemporary commercial singers. A randomized controlled study was carried out. Thirty professional or semi-professional singers with no voice complaints were randomly divided into two groups on recruitment: an experimental group and a control group. The same warm-up exercise was performed by the experimental group with an occluded ventilation mask placed over the nose and the mouth and by the control group without the ventilation mask. Voice was recorded before and after the exercise. Acoustic and self-assessment analysis were accomplished. The acoustic parameters of the voice samples recorded before and after training were compared, as well as the parameters' variations between the experimental and the control group. Self-assessment results of the experimental and the control group were compared too. Significant changes after the warm-up exercise included jitter, shimmer, and singing power ratio (SPR) in the experimental group. No significant changes were recorded in the control group. Significant differences between the experimental and the control group were found for ΔShimmer and ΔSPR. Self-assessment analysis confirmed a significantly higher phonatory comfort and voice quality perception for the experimental group. The results of the present study support the immediate advantageous effects on singing voice of a semi-occluded vocal tract exercise with a ventilation mask in terms of acoustic quality, phonatory comfort, and voice quality perception in contemporary commercial singers. Long-term effects still remain to be studied. Copyright © 2017 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Evaluation of dexamethasone phosphate delivered by ocular iontophoresis for treating noninfectious anterior uveitis.

PubMed

Cohen, Amy E; Assang, Carol; Patane, Michael A; From, Stephen; Korenfeld, Michael

2012-01-01

Determine safe, effective, iontophoretic dose(s) of EGP-437 (dexamethasone phosphate formulated for iontophoresis) in patients with noninfectious anterior uveitis; evaluate systemic drug exposures. Prospective, phase I/II, multicenter, double-masked, parallel group, randomized clinical trial. Forty outpatients with anterior uveitis. Forty of 42 randomized patients received an iontophoresis treatment in 1 qualifying eye and completed the study. Patients were randomized into 1 of 4 iontophoresis dose groups (1.6, 4.8, 10.0, or 14.0 mA-min), treated with EGP-437 via the EyeGate II Delivery System (EGDS), and followed until day 28. The main outcome measures were anterior chamber cell (ACC) scores at days 14 and 28; time to ACC score of zero; proportion of patients with an ACC score reduction from baseline of ≥ 0.5 at day 28; mean change from baseline in ACC score at day 28; and the systemic exposures of dexamethasone and dexamethasone phosphate after EGP-437 treatment with the EGDS. After a single EGP-437 treatment, 19 of 40 patients (48%) achieved an ACC score of zero at day 14. By day 28, 24 of 40 patients (60%) achieved an ACC score of zero. A Kaplan-Meier analysis demonstrated that the 1.6 mA-min dose was the most effective and revealed an inverse dose response; median days to an ACC score of zero were 11.5 days in the 1.6 mA-min group versus 31 days in the 14.0 mA-min group. Twenty-six patients (65%) had an ACC score reduction from baseline of ≥ 0.5 at day 28. The mean change in ACC score from baseline to day 28 was -2.14 with a median of -2.00. Throughout the study, the mean intraocular pressure remained within normal range and mean best-corrected visual acuity at 4 meters remained relatively stable. Most adverse events were mild; no serious adverse events were reported. Pharmacokinetics results showed low short-term systemic exposure to dexamethasone after iontophoresis; no nonocular systemic corticosteroid-mediated effects were observed. Approximately two thirds of the patients reached an ACC score of zero within 28 days, after only receiving 1 iontophoresis treatment. The lower doses seemed to be the most effective, and treatments were well-tolerated. Proprietary or commercial disclosure may be found after the references. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Nepafenac 0.3% after Cataract Surgery in Patients with Diabetic Retinopathy: Results of 2 Randomized Phase 3 Studies.

PubMed

Singh, Rishi P; Lehmann, Robert; Martel, Joseph; Jong, Kevin; Pollack, Ayala; Tsorbatzoglou, Alexis; Staurenghi, Giovanni; Cervantes-Coste Cervantes, Guadalupe; Alpern, Louis; Modi, Satish; Svoboda, Liza; Adewale, Adeniyi; Jaffe, Glenn J

2017-06-01

To demonstrate the efficacy and safety of once-daily nepafenac 0.3% ophthalmic suspension versus vehicle, based on clinical outcomes, after cataract surgery in patients with diabetes. Two prospective, randomized, multicenter, double-masked, vehicle-controlled phase 3 studies. Total, 615 patients in study 1 and 605 patients in study 2. Patients were randomized (1:1) to topical nepafenac 0.3% or vehicle once-daily starting the day before surgery and continuing for 90 days thereafter. Key efficacy variables were: patients (%) in whom macular edema (ME) developed (≥30% increase from preoperative baseline central subfield macular thickness) within 90 days after cataract surgery and the patients (%) with a best-corrected visual acuity (BCVA) improvement of ≥15 letters from preoperative baseline through day 14 maintained through day 90. Secondary end points included: patients (%) with a BCVA improvement of ≥15 letters from preoperative baseline through days 90 and 60 and safety over 3 months. A significantly lower percentage of patients demonstrated ME within 90 days after surgery with nepafenac 0.3% versus vehicle (study 1: 2.3% vs. 17.3%; P < 0.001; study 2: 5.9% vs. 14.3%; P = 0.001; pooled: 4.1% vs. 15.9%; P < 0.001). The percentage of patients achieving a ≥15-letter improvement from baseline through day 14 maintained through day 90 with nepafenac 0.3% versus vehicle was 61.7% versus 43.0% (P < 0.001) in study 1, 48.8% versus 50.5% (P = 0.671) in study 2, and 55.4% versus 46.7% (P = 0.003) in the pooled analysis. A greater percentage of patients treated with nepafenac 0.3% versus vehicle in study 1 and similar percentage in study 2 had a BCVA improvement of ≥15 letters from preoperative baseline through day 90 (77.2% vs. 67.7% [P = 0.009] and 65.4% vs. 65.9% [P = 0.888]) and through day 60 (76.2% vs. 64.7% [P = 0.002] and 68.9% vs. 62.1% [P = 0.092]). No unanticipated adverse events were observed. These studies demonstrated the clinical benefits of nepafenac 0.3% over vehicle in reducing the risk of postoperative ME, with the integrated analysis showing improved BCVA after cataract surgery in patients with diabetic retinopathy, with no unanticipated safety events. Copyright © 2017 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Health status, resource consumption, and costs of dysthymia. A multi-center two-year longitudinal study.

PubMed

Barbui, Corrado; Motterlini, Nicola; Garattini, Livio

2006-02-01

In this study we estimated the health status, resource consumption and costs of a large cohort of patients with early and late-onset dysthymia. The DYSCO (DYSthymia COsts) project is a multi-center observational study which prospectively followed for two years a randomly chosen sample of patients with dysthymia in the Italian primary health care system. A total of 501 patients were followed for two years; 81% had early-onset dysthymic disorder. During the study, improvement was seen in most domains of the 36-Item Short Form Health Survey (SF-36) questionnaire. Comparison of the SF-36 scores for the two groups showed that only the physical health index significantly differed during the two years. The use of outpatient consultations, laboratory tests and diagnostic procedures was similar in the two groups, but patients with early-onset dysthymia were admitted significantly more than late-onset cases. Hospital admissions were almost entirely responsible for the higher total cost per patient per year of early-onset dysthymia. A first limitation of this study is that general practitioners were selected on the basis of their willingness to participate, not at random; secondly, no information was collected on concomitant psychiatric comorbidities. The present study provides the first prospective, long-term data on service use and costs in patients with dysthymia. Differently from patients with early-onset dysthymia, patients with late-onset dysthymia were admitted less and cost less.

Three-dimensional information hierarchical encryption based on computer-generated holograms

NASA Astrophysics Data System (ADS)

Kong, Dezhao; Shen, Xueju; Cao, Liangcai; Zhang, Hao; Zong, Song; Jin, Guofan

2016-12-01

A novel approach for encrypting three-dimensional (3-D) scene information hierarchically based on computer-generated holograms (CGHs) is proposed. The CGHs of the layer-oriented 3-D scene information are produced by angular-spectrum propagation algorithm at different depths. All the CGHs are then modulated by different chaotic random phase masks generated by the logistic map. Hierarchical encryption encoding is applied when all the CGHs are accumulated one by one, and the reconstructed volume of the 3-D scene information depends on permissions of different users. The chaotic random phase masks could be encoded into several parameters of the chaotic sequences to simplify the transmission and preservation of the keys. Optical experiments verify the proposed method and numerical simulations show the high key sensitivity, high security, and application flexibility of the method.

Place specificity of monopolar and tripolar stimuli in cochlear implants: the influence of residual masking.

PubMed

Fielden, Claire A; Kluk, Karolina; McKay, Colette M

2013-06-01

This experiment investigated whether place specificity of neural activity evoked by cochlear implant stimulation is improved in tripolar compared to monopolar mode using a forward masking protocol addressing some limitations of previous methods of measurement and analysis. The amount of residual masking (masking remaining at long masker-probe delays) was also measured, and its potential influence on the specificity measures was evaluated. The masker stimulus comprised equally loud interleaved mono- or tripolar stimulation on two electrodes equidistant from a central probe electrode in an apical and basal direction, reducing the influence of off-site listening. The effect of masker-probe distance on the threshold shift of the tripolar probe was analyzed to derive a measure of place specificity. On average, tripolar maskers were more place specific than monopolar maskers, although the mean effect was small. There was no significant effect of masker level on specificity or on the differences observed between modes. The mean influence of residual masking on normalized masking functions was similar for the two modes and, therefore, did not influence the comparison of specificity between the modes. However, variability in amount of residual masking was observed between subjects, and therefore should be considered in forward masking studies that compare place specificity across subjects.

Assessment of iron deficiency and anemia in pregnant women: an observational French study.

PubMed

Harvey, Thierry; Zkik, Asmaa; Auges, Marie; Clavel, Thierry

2016-01-01

We explored the prevalence and management of iron deficiency and anemia among pregnant women in France. In this prospective, observational, multicenter registry study, randomly selected investigators (gynecologists/obstetricians/midwives registered in the CEGEDIM(®) database) assessed pregnant women presenting for a consultation. Participants completed a questionnaire at study inclusion. A total of 1506 patients were enrolled by 95 investigators. Overall, investigators estimated a moderate or significant risk of iron deficiency in almost 60% of women. The overall prevalence of anemia (15.8%) increased with longer pregnancy duration. Medication (mainly iron-based) was prescribed to 57.3% of patients. In French clinical practice, the estimated risk of iron deficiency and prevalence of anemia during pregnancy align with expectations and are managed according to national/international recommendations.

Actinic inspection of EUV reticles with arbitrary pattern design

NASA Astrophysics Data System (ADS)

Mochi, Iacopo; Helfenstein, Patrick; Rajeev, Rajendran; Fernandez, Sara; Kazazis, Dimitrios; Yoshitake, Shusuke; Ekinci, Yasin

2017-10-01

The re ective-mode EUV mask scanning lensless imaging microscope (RESCAN) is being developed to provide actinic mask inspection capabilities for defects and patterns with high resolution and high throughput, for 7 nm node and beyond. Here we, will report on our progress and present the results on programmed defect detection on random, logic-like patterns. The defects we investigated range from 200 nm to 50 nm size on the mask. We demonstrated the ability of RESCAN to detect these defects in die-to-die and die-to-database mode with a high signal to noise ratio. We also describe future plans for the upgrades to increase the resolution, the sensitivity, and the inspection speed of the demo tool.

Bromfenac 0.09% bioavailability in aqueous humor, prophylactic effect on cystoid macular edema, and clinical signs of ocular inflammation after phacoemulsification in a Mexican population

PubMed Central

Palacio, Claudia; Fernández De Ortega, Lourdes; Bustos, Francisco R; Chávez, Eduardo; Oregon-Miranda, Aldo A; Mercado-Sesma, Arieh R

2016-01-01

Purpose The purpose of this study was to evaluate the aqueous humor bioavailability and clinical efficacy of bromfenac 0.09% vs nepafenac on the presence of cystoid macular edema (CME) after phacoemulsification. Material and methods A Phase II, double-blind, masked, active-controlled, multicenter, clinical trial of 139 subjects, randomized to either a bromfenac 0.09% ophthalmic solution (n=69) or nepafenac 0.1% (n=70). Subjects instilled a drop three times a day for a period of 30 days. Follow-up visits were on days 2, 7, 15, 30, and 60. Biomicroscopy, clinical ocular signs, and assessment of posterior segment were performed. The primary efficacy endpoints included the presence of CME evaluated by optical coherence tomography. Safety evaluation included intraocular pressure, transaminase enzymes, lissamine green, and fluorescein stain. Results The demographic and efficacy variables were similar between groups at baseline. The presence of pain, photophobia, conjunctival hyperemia, chemosis, cellularity, and corneal edema disappeared by day 30 in both groups. The central retinal thickness did not show significant changes after treatment when compared to baseline as follows: in the bromfenac group (247.2±32.9 vs 252.0±24.9 μm; P=0.958) and in nepafenac group (250.8±34 vs 264.0±34.1 μm; P=0.137), respectively. A statistically significant difference was observed between bromfenac and nepafenac group: (252.0±24.9 vs 264.0±34.1 μm; P=0.022), at day 30, respectively; even though there was no clinical relevance in the presentation of CME. There were no significant alterations in intraocular pressure, either lissamine green or fluorescein stains. The adverse events were not related to the interventions. Conclusion Bromfenac 0.09% ophthalmic solution showed similar clinical efficacy to reduce the presentation of CME after phacoemulsification compared to nepafenac 0.01%. PMID:26869758

Bromfenac 0.09% bioavailability in aqueous humor, prophylactic effect on cystoid macular edema, and clinical signs of ocular inflammation after phacoemulsification in a Mexican population.

PubMed

Palacio, Claudia; Fernández De Ortega, Lourdes; Bustos, Francisco R; Chávez, Eduardo; Oregon-Miranda, Aldo A; Mercado-Sesma, Arieh R

2016-01-01

The purpose of this study was to evaluate the aqueous humor bioavailability and clinical efficacy of bromfenac 0.09% vs nepafenac on the presence of cystoid macular edema (CME) after phacoemulsification. A Phase II, double-blind, masked, active-controlled, multicenter, clinical trial of 139 subjects, randomized to either a bromfenac 0.09% ophthalmic solution (n=69) or nepafenac 0.1% (n=70). Subjects instilled a drop three times a day for a period of 30 days. Follow-up visits were on days 2, 7, 15, 30, and 60. Biomicroscopy, clinical ocular signs, and assessment of posterior segment were performed. The primary efficacy endpoints included the presence of CME evaluated by optical coherence tomography. Safety evaluation included intraocular pressure, transaminase enzymes, lissamine green, and fluorescein stain. The demographic and efficacy variables were similar between groups at baseline. The presence of pain, photophobia, conjunctival hyperemia, chemosis, cellularity, and corneal edema disappeared by day 30 in both groups. The central retinal thickness did not show significant changes after treatment when compared to baseline as follows: in the bromfenac group (247.2±32.9 vs 252.0±24.9 μm; P=0.958) and in nepafenac group (250.8±34 vs 264.0±34.1 μm; P=0.137), respectively. A statistically significant difference was observed between bromfenac and nepafenac group: (252.0±24.9 vs 264.0±34.1 μm; P=0.022), at day 30, respectively; even though there was no clinical relevance in the presentation of CME. There were no significant alterations in intraocular pressure, either lissamine green or fluorescein stains. The adverse events were not related to the interventions. Bromfenac 0.09% ophthalmic solution showed similar clinical efficacy to reduce the presentation of CME after phacoemulsification compared to nepafenac 0.01%.

Efficacy and Safety of Topical Rapamycin in Patients With Facial Angiofibromas Secondary to Tuberous Sclerosis Complex: The TREATMENT Randomized Clinical Trial.

PubMed

Koenig, Mary Kay; Bell, Cynthia S; Hebert, Adelaide A; Roberson, Joan; Samuels, Joshua A; Slopis, John M; Tate, Patti; Northrup, Hope

2018-05-23

Facial angiofibromas occur in approximately 75% of individuals with tuberous sclerosis complex (TSC), causing substantial morbidity and disfigurement. Current therapies are partially effective, uncomfortable, produce scarring, and need repeating to treat recurrence. To evaluate the efficacy and safety of topical rapamycin for TSC-related facial angiofibromas. This prospective, multicenter, randomized, double-blind, vehicle-controlled trial with 6 monthly clinic visits enrolled 179 patients with TSC-related facial angiofibromas not treated within 6 months from May 2012 to March 2014 in 9 clinical sites in the United States and 1 in Australia. Patients were randomized (1:1:1) to topical formulation containing 0.3 g per 30 g (1%) rapamycin, 0.03 g per 30 g (0.1%) rapamycin, or vehicle alone. Participants applied 1.0 mL to designated areas daily at bedtime. Angiofibroma Grading Scale (AGS) change from baseline scored from photographs by independent masked dermatologists. Safety analyses included adverse events (AEs) and serum rapamycin levels. All 179 patients randomized (99 [55.3%] female) comprised the primary analysis population (59 in the 1% rapamycin group, 63 in the 0.1% rapamycin group, and 57 in the vehicle-only group). The mean age was 20.5 years (range 3-61 years). Clinically meaningful and statistically significant improvement in facial angiofibromas was observed for both 1% and 0.1% rapamycin relative to the vehicle-only control group, and for 1% vs 0.1% rapamycin, with most of the improvement realized within the first month. At 6 months, AGS mean improvement for 1% rapamycin was 16.7 points compared with 11.0 for 0.1% rapamycin and 2.1 points for vehicle only (P < .001 for 1% and 0.1% vs vehicle only). Compared with baseline, end-of-treatment photos were rated "better" for 81.8% of patients in the 1% rapamycin group, compared with 65.5% for those in the 0.1% rapamycin group and 25.5% for those in the vehicle-only group (P < .001, all 3 pairwise comparisons). Topical rapamycin was generally well-tolerated, with no measurable systemic absorption. Apparent drug-related adverse effects were limited to 10% or less incidence of application site discomfort and/or pain, pruritus, erythema, and irritation. Nearly all AEs were mild, with no drug-related moderate, severe, or serious events. Topical rapamycin appears effective and safe for treatment of TSC-related facial angiofibromas. In this trial, the preferred dose was 1% once daily. Future studies are needed to evaluate prophylactic, early, and long-term use of topical rapamycin, durability of response, and combination therapy with oral mammalian target of rapamycin (mTOR) inhibitors. ClinicalTrials.gov Identifier: NCT01526356.

Vision-Related Quality-of-Life Outcomes in the Mycotic Ulcer Treatment Trial I: A Randomized Clinical Trial.

PubMed

Rose-Nussbaumer, Jennifer; Prajna, N Venkatesh; Krishnan, K Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E; O'Brien, Kieran S; Ray, Kathryn J; McLeod, Stephen D; Porco, Travis C; Lietman, Thomas M; Acharya, Nisha R; Keenan, Jeremy D

2015-06-01

Given the limitations in health care resources, quality-of-life measures for interventions have gained importance. To determine whether vision-related quality-of-life outcomes were different between the natamycin and voriconazole treatment arms in the Mycotic Ulcer Treatment Trial I, as measured by an Indian Vision Function Questionnaire. Secondary analysis (performed October 11-25, 2014) of a double-masked, multicenter, randomized, active comparator-controlled, clinical trial at multiple locations of the Aravind Eye Care System in South India that enrolled patients with culture- or smear-positive filamentous fungal corneal ulcers who had a baseline visual acuity of 20/40 to 20/400 (logMAR of 0.3-1.3). Study participants were randomly assigned to topical voriconazole, 1%, or topical natamycin, 5%. Subscale score on the Indian Vision Function Questionnaire from each of the 4 subscales (mobility, activity limitation, psychosocial impact, and visual function) at 3 months. A total of 323 patients were enrolled in the trial, and 292 (90.4%) completed the Indian Vision Function Questionnaire at 3 months. The majority of study participants had subscale scores consistent with excellent function. After adjusting for baseline visual acuity and organism, we found that study participants in the natamycin-treated group scored, on average, 4.3 points (95% CI, 0.1-8.5) higher than study participants in the voriconazole-treated group (P = .046). In subgroup analyses looking at ulcers caused by Fusarium species and adjusting for baseline best spectacle-corrected visual acuity, the natamycin-treated group scored 8.4 points (95% CI, 1.9-14.9) higher than the voriconazole-treated group (P = .01). Differences in quality of life were not detected for patients with Aspergillus or other non-Fusarium species as the causative organism (1.5 points [95% CI, -3.9 to 6.9]; P = .52). We found evidence of improvement in vision-related quality of life among patients with fungal ulcers who were randomly assigned to natamycin compared with those randomly assigned to voriconazole, and especially among patients with Fusarium species as the causative organism. Incorporation of quality-of-life measures in clinical trials is important to fully evaluate the effect of the studied interventions. clinicaltrials.gov Identifier:NCT00996736.

Metformin in women with type 2 diabetes in pregnancy (MiTy): a multi-center randomized controlled trial.

PubMed

Feig, Denice S; Murphy, Kellie; Asztalos, Elizabeth; Tomlinson, George; Sanchez, Johanna; Zinman, Bernard; Ohlsson, Arne; Ryan, Edmond A; Fantus, I George; Armson, Anthony B; Lipscombe, Lorraine L; Barrett, Jon F R

2016-07-19

The incidence of type 2 diabetes in pregnancy is rising and rates of serious adverse maternal and fetal outcomes remain high. Metformin is a biguanide that is used as first-line treatment for non-pregnant patients with type 2 diabetes. We hypothesize that metformin use in pregnancy, as an adjunct to insulin, will decrease adverse outcomes by reducing maternal hyperglycemia, maternal insulin doses, maternal weight gain and gestational hypertension/pre-eclampsia. In addition, since metformin crosses the placenta, metformin treatment of the fetus may have a direct beneficial effect on neonatal outcomes. Our aim is to compare the effectiveness of the addition of metformin to insulin, to standard care (insulin plus placebo) in women with type 2 diabetes in pregnancy. The MiTy trial is a multi-centre randomized trial currently enrolling pregnant women with type 2 diabetes, who are on insulin, between the ages of 18-45, with a gestational age of 6 weeks 0 days to 22 weeks 6 days. In this randomized, double-masked, parallel placebo-controlled trial, after giving informed consent, women are randomized to receive either metformin 1,000 mg twice daily or placebo twice daily. A web-based block randomization system is used to assign women to metformin or placebo in a 1:1 ratio, stratified for site and body mass index. The primary outcome is a composite neonatal outcome of pregnancy loss, preterm birth, birth injury, moderate/severe respiratory distress, neonatal hypoglycemia, or neonatal intensive care unit admission longer than 24 h. Secondary outcomes are large for gestational age, cord blood gas pH < 7.0, congenital anomalies, hyperbilirubinemia, sepsis, hyperinsulinemia, shoulder dystocia, fetal fat mass, as well as maternal outcomes: maternal weight gain, maternal insulin doses, maternal glycemic control, maternal hypoglycemia, gestational hypertension, preeclampsia, cesarean section, number of hospitalizations during pregnancy, and duration of hospital stays. The trial aims to enroll 500 participants. The results of this trial will inform endocrinologists, obstetricians, family doctors, and other healthcare professionals caring for women with type 2 diabetes in pregnancy, as to the benefits of adding metformin to insulin in this high risk population. ClinicalTrials.gov Identifier: no. NCT01353391 . Registered February 6, 2009.

Calibration of a Spatial-Temporal Discrimination Model from Forward, Simultaneous, and Backward Masking

NASA Technical Reports Server (NTRS)

Ahumada, Albert J.; Beard, B. L.; Stone, Leland (Technical Monitor)

1997-01-01

We have been developing a simplified spatial-temporal discrimination model similar to our simplified spatial model in that masking is assumed to be a function of the local visible contrast energy. The overall spatial-temporal sensitivity of the model is calibrated to predict the detectability of targets on a uniform background. To calibrate the spatial-temporal integration functions that define local visible contrast energy, spatial-temporal masking data are required. Observer thresholds were measured (2IFC) for the detection of a 12 msec target stimulus in the presence of a 700 msec mask. Targets were 1, 3 or 9 c/deg sine wave gratings. Masks were either one of these gratings or two of them combined. The target was presented in 17 temporal positions with respect to the mask, including positions before, during and after the mask. Peak masking was found near mask onset and offset for 1 and 3 c/deg targets, while masking effects were more nearly uniform during the mask for the 9 c/deg target. As in the purely spatial case, the simplified model can not predict all the details of masking as a function of masking component spatial frequencies, but overall the prediction errors are small.

The detrimental effects of atypical nonverbal behavior on older adults' first impressions of individuals with Parkinson's disease.

PubMed

Hemmesch, Amanda R

2014-09-01

After viewing short video clips of individuals with Parkinson's disease (PD) who varied in the symptoms of facial masking (reduced expressivity) and abnormal bodily movement (ABM: including tremor and related movement disorders), older adult observers provided their first impressions of targets' social positivity. Impressions of targets with higher masking or ABM were more negative than impressions of targets with lower masking or ABM. Furthermore, masking was more detrimental for impressions of women and when observers considered emotional relationship goals, whereas ABM was more detrimental for instrumental relationship goals. This study demonstrated the stigmatizing effects of both reduced and excessive movement. PsycINFO Database Record (c) 2014 APA, all rights reserved.

Compliance with the Use of Medical and Cloth Masks Among Healthcare Workers in Vietnam.

PubMed

Chughtai, Abrar Ahmad; Seale, Holly; Dung, Tham Chi; Hayen, Andrew; Rahman, Bayzidur; Raina MacIntyre, C

2016-06-01

Masks are often worn in healthcare settings to prevent the spread of infection from healthcare workers (HCWs) to patients. Masks are also used to protect the employee from patient-generated infectious organisms but poor compliance can reduce efficacy. The aim of this study was to examine the factors influencing compliance with the use of medical and cloth masks amongst hospital HCWs. HCWs compliance with the use of medical and cloth masks was measured over a 4-week period in a randomized controlled trial in Vietnam. HCWs were instructed to record their daily activities in diary cards. Demographic, clinical, and diary card data were used to determine the predictors of compliance and the relationship of compliance with infection outcomes. Compliance rates for both medical and cloth masks decreased during the 4 weeks: medical mask use decreased from 77 to 68% (P < 0.001) and cloth masks from 78 to 69% (P < 0.001). The presence of adverse events (adjusted RR 0.90, 95% CI 0.85-0.95), and performing aerosol-generating procedures (adjusted RR 0.78, 95% CI 0.73-0.82) were negatively associated with compliance, while contact with febrile respiratory illness patients was positively associated (adjusted RR 1.14, 95% CI 1.07-1.20). Being compliant with medical or cloth masks use (average use ≥70% of working time) was not associated with clinical respiratory illness, influenza-like illness, and laboratory-confirmed viral infection. Understanding the factors that affect compliance is important for the occupational health and safety of HCWs. New strategies and tools should be developed to increase compliance of HCWs. The presence of adverse events such as discomfort and breathing problems may be the main reasons for the low compliance with mask use and further studies should be conducted to improve the design/material of masks to improve comfort for the wearer. © The Author 2016. Published by Oxford University Press on behalf of the British Occupational Hygiene Society.

Refinement of the CALIOP cloud mask algorithm

NASA Astrophysics Data System (ADS)

Katagiri, Shuichiro; Sato, Kaori; Ohta, Kohei; Okamoto, Hajime

2018-04-01

A modified cloud mask algorithm was applied to the CALIOP data to have more ability to detect the clouds in the lower atmosphere. In this algorithm, we also adopt the fully attenuation discrimination and the remain noise estimation using the data obtained at an altitude of 40 km to avoid contamination of stratospheric aerosols. The new cloud mask shows an increase in the lower cloud fraction. Comparison of the results to the data observed with a PML ground observation was also made.

Longitudinal comparison of outcomes after sub-Bowman keratomileusis and laser in situ keratomileusis: randomized, double-masked study.

PubMed

Wong, Rachel Chung Yin; Yu, Marco; Chan, Tommy C Y; Chong, Kelvin K L; Jhanji, Vishal

2015-05-01

To compare the outcomes of sub-Bowman keratomileusis (100-μm flap) and laser in situ keratomileusis (LASIK) (120-μm flap) using 150-kHz femtosecond laser. Randomized, double-masked, contralateral clinical trial. One hundred patients (200 eyes) with myopia or myopic astigmatism were included. Postoperative examinations were performed at week 1 and months 1, 3, 6, and 12. Main outcome measures included postoperative uncorrected (UCVA) and best-corrected distance visual acuity (BCVA); manifest refraction spherical equivalent; efficacy and safety indices; corneal thickness; and complications. The mean age of patients was 33.9 ± 7.9 years. Overall, the preoperative UCVA, BCVA, and manifest refraction spherical equivalent were 1.349 ± 0.332, -0.022 ± 0.033, and -5.81 ± 1.61 diopters, respectively. No significant difference was observed in preoperative (P ≥ .226) or intraoperative parameters (P ≥ .452) between both groups, except residual stromal thickness (P < .001). The UCVA, manifest refraction spherical equivalent, and central corneal thickness stabilized by 1 week, while the thinnest corneal thickness stabilized by 3 months postoperatively. There was no significant difference between both groups for any parameter during all follow-up visits (P ≥ .132) except the 3-month safety index, which was better in the sub-Bowman keratomileusis group (P = .007). Soft opaque bubble layer was noted intraoperatively in 12 cases (7, 100-μm group; 5, 120-μm group; P = .577). No postoperative complications were observed. Our study did not find any differences in the visual and refractive outcomes between femtosecond-assisted sub-Bowman keratomileusis and LASIK. Both surgeries resulted in quick visual recovery as early as 1 week postoperatively. Copyright © 2015 Elsevier Inc. All rights reserved.

Force-dependent static dead space of face masks used with holding chambers.

PubMed

Shah, Samir A; Berlinski, Ariel B; Rubin, Bruce K

2006-02-01

Pressurized metered-dose inhalers with valved holding chambers and masks are commonly used for aerosol delivery in children. Drug delivery can decrease when the dead-space volume (DSV) of the valved holding chamber is increased, but there are no published data evaluating force-dependent DSV among different masks. Seven masks were studied. Masks were sealed at the valved holding chamber end and filled with water to measure mask volume. To measure mask DSV we used a mannequin of 2-year-old-size face and we applied the mask with forces of 1.5, 3.5, and 7 pounds. Mask seal was determined by direct observation. Intra-brand analysis was done via analysis of variance. At 3.5 pounds of force, the DSV ranged from 29 mL to 100 mL, with 3 masks having DSV of < 50 mL. The remaining masks all had DSV > 60 mL. At 3.5 pounds of force, DSV percent of mask volume ranged from 33.7% (Aerochamber, p < 0.01 compared with other masks) to 100% (Pocket Chamber). DSV decreased with increasing force with most of the masks, and the slope of this line was inversely proportional to mask flexibility. Mask fit was 100% at 1.5 pounds of force only with the Aerochamber and Optichamber. Mask fit was poorest with the Vortex, Pocket Chamber, and BreatheRite masks. Rigid masks with large DSV might not be not suitable for use in children, especially if discomfort from the stiff mask makes its use less acceptable to the child.

Antibiotics-First Versus Surgery for Appendicitis: A US Pilot Randomized Controlled Trial Allowing Outpatient Antibiotic Management.

PubMed

Talan, David A; Saltzman, Darin J; Mower, William R; Krishnadasan, Anusha; Jude, Cecilia M; Amii, Ricky; DeUgarte, Daniel A; Wu, James X; Pathmarajah, Kavitha; Morim, Ashkan; Moran, Gregory J

2017-07-01

Randomized trials suggest that nonoperative treatment of uncomplicated appendicitis with antibiotics-first is safe. No trial has evaluated outpatient treatment and no US randomized trial has been conducted, to our knowledge. This pilot study assessed feasibility of a multicenter US study comparing antibiotics-first, including outpatient management, with appendectomy. Patients aged 5 years or older with uncomplicated appendicitis at 1 US hospital were randomized to appendectomy or intravenous ertapenem greater than or equal to 48 hours and oral cefdinir and metronidazole. Stable antibiotics-first-treated participants older than 13 years could be discharged after greater than or equal to 6-hour emergency department (ED) observation with next-day follow-up. Outcomes included 1-month major complication rate (primary) and hospital duration, pain, disability, quality of life, and hospital charges, and antibiotics-first appendectomy rate. Of 48 eligible patients, 30 (62.5%) consented, of whom 16 (53.3%) were randomized to antibiotics-first and 14 (46.7%) to appendectomy. Median age was 33 years (range 9 to 73 years), median WBC count was 15,000/μL (range 6,200 to 23,100/μL), and median computed tomography appendiceal diameter was 10 mm (range 7 to 18 mm). Of 15 antibiotic-treated adults, 14 (93.3%) were discharged from the ED and all had symptom resolution. At 1 month, major complications occurred in 2 appendectomy participants (14.3%; 95% confidence interval [CI] 1.8% to 42.8%) and 1 antibiotics-first participant (6.3%; 95% CI 0.2% to 30.2%). Antibiotics-first participants had less total hospital time than appendectomy participants, 16.2 versus 42.1 hours, respectively. Antibiotics-first-treated participants had less pain and disability. During median 12-month follow-up, 2 of 15 antibiotics-first-treated participants (13.3%; 95% CI 3.7% to 37.9%) developed appendicitis and 1 was treated successfully with antibiotics; 1 had appendectomy. No more major complications occurred in either group. A multicenter US trial comparing antibiotics-first to appendectomy, including outpatient management, is feasible to evaluate efficacy and safety. Copyright © 2016 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

Acute pancreatitis patient registry to examine novel therapies in clinical experience (APPRENTICE): an international, multicenter consortium for the study of acute pancreatitis.

PubMed

Papachristou, Georgios I; Machicado, Jorge D; Stevens, Tyler; Goenka, Mahesh Kumar; Ferreira, Miguel; Gutierrez, Silvia C; Singh, Vikesh K; Kamal, Ayesha; Gonzalez-Gonzalez, Jose A; Pelaez-Luna, Mario; Gulla, Aiste; Zarnescu, Narcis O; Triantafyllou, Konstantinos; Barbu, Sorin T; Easler, Jeffrey; Ocampo, Carlos; Capurso, Gabriele; Archibugi, Livia; Cote, Gregory A; Lambiase, Louis; Kochhar, Rakesh; Chua, Tiffany; Tiwari, Subhash Ch; Nawaz, Haq; Park, Walter G; de-Madaria, Enrique; Lee, Peter J; Wu, Bechien U; Greer, Phil J; Dugum, Mohannad; Koutroumpakis, Efstratios; Akshintala, Venkata; Gougol, Amir

2017-01-01

We have established a multicenter international consortium to better understand the natural history of acute pancreatitis (AP) worldwide and to develop a platform for future randomized clinical trials. The AP patient registry to examine novel therapies in clinical experience (APPRENTICE) was formed in July 2014. Detailed web-based questionnaires were then developed to prospectively capture information on demographics, etiology, pancreatitis history, comorbidities, risk factors, severity biomarkers, severity indices, health-care utilization, management strategies, and outcomes of AP patients. Between November 2015 and September 2016, a total of 20 sites (8 in the United States, 5 in Europe, 3 in South America, 2 in Mexico and 2 in India) prospectively enrolled 509 AP patients. All data were entered into the REDCap (Research Electronic Data Capture) database by participating centers and systematically reviewed by the coordinating site (University of Pittsburgh). The approaches and methodology are described in detail, along with an interim report on the demographic results. APPRENTICE, an international collaboration of tertiary AP centers throughout the world, has demonstrated the feasibility of building a large, prospective, multicenter patient registry to study AP. Analysis of the collected data may provide a greater understanding of AP and APPRENTICE will serve as a future platform for randomized clinical trials.

Pre-saccadic perception: Separate time courses for enhancement and spatial pooling at the saccade target

PubMed Central

Buonocore, Antimo; Fracasso, Alessio; Melcher, David

2017-01-01

We interact with complex scenes using eye movements to select targets of interest. Studies have shown that the future target of a saccadic eye movement is processed differently by the visual system. A number of effects have been reported, including a benefit for perceptual performance at the target (“enhancement”), reduced influences of backward masking (“un-masking”), reduced crowding (“un-crowding”) and spatial compression towards the saccade target. We investigated the time course of these effects by measuring orientation discrimination for targets that were spatially crowded or temporally masked. In four experiments, we varied the target-flanker distance, the presence of forward/backward masks, the orientation of the flankers and whether participants made a saccade. Masking and randomizing flanker orientation reduced performance in both fixation and saccade trials. We found a small improvement in performance on saccade trials, compared to fixation trials, with a time course that was consistent with a general enhancement at the saccade target. In addition, a decrement in performance (reporting the average flanker orientation, rather than the target) was found in the time bins nearest saccade onset when random oriented flankers were used, consistent with spatial pooling around the saccade target. We did not find strong evidence for un-crowding. Overall, our pattern of results was consistent with both an early, general enhancement at the saccade target and a later, peri-saccadic compression/pooling towards the saccade target. PMID:28614367

Single-channel 40 Gbit/s digital coherent QAM quantum noise stream cipher transmission over 480 km.

PubMed

Yoshida, Masato; Hirooka, Toshihiko; Kasai, Keisuke; Nakazawa, Masataka

2016-01-11

We demonstrate the first 40 Gbit/s single-channel polarization-multiplexed, 5 Gsymbol/s, 16 QAM quantum noise stream cipher (QNSC) transmission over 480 km by incorporating ASE quantum noise from EDFAs as well as the quantum shot noise of the coherent state with multiple photons for the random masking of data. By using a multi-bit encoded scheme and digital coherent transmission techniques, secure optical communication with a record data capacity and transmission distance has been successfully realized. In this system, the signal level received by Eve is hidden by both the amplitude and the phase noise. The highest number of masked signals, 7.5 x 10(4), was achieved by using a QAM scheme with FEC, which makes it possible to reduce the output power from the transmitter while maintaining an error free condition for Bob. We have newly measured the noise distribution around I and Q encrypted data and shown experimentally with a data size of as large as 2(25) that the noise has a Gaussian distribution with no correlations. This distribution is suitable for the random masking of data.

The Effectiveness of Parent Training as a Treatment for Preschool Attention-Deficit/Hyperactivity Disorder: Study Protocol for a Randomized Controlled, Multicenter Trial of the New Forest Parenting Program in Everyday Clinical Practice

PubMed Central

Daley, David; Frydenberg, Morten; Rask, Charlotte U; Sonuga-Barke, Edmund; Thomsen, Per H

2016-01-01

Background Parent training is recommended as the first-line treatment for attention-deficit/hyperactivity disorder (ADHD) in preschool children. The New Forest Parenting Programme (NFPP) is an evidence-based parenting program developed specifically to target preschool ADHD. Objective The objective of this trial is to investigate whether the NFPP can be effectively delivered for children referred through official community pathways in everyday clinical practice. Methods A multicenter randomized controlled parallel arm trial design is employed. There are two treatment arms, NFPP and treatment as usual. NFPP consists of eight individually delivered parenting sessions, where the child attends during three of the sessions. Outcomes are examined at three time points (T1, T2, T3): T1 (baseline), T2 (week 12, post intervention), and T3 (6 month follow/up). 140 children between the ages of 3-7, with a clinical diagnosis of ADHD, informed by the Development and Well Being Assessment, and recruited from three child and adolescent psychiatry departments in Denmark will take part. Randomization is on a 1:1 basis, stratified for age and gender. Results The primary endpoint is change in ADHD symptoms as measured by the Preschool ADHD-Rating Scale (ADHD-RS) by T2. Secondary outcome measures include: effects on this measure at T3 and T2 and T3 measures of teacher reported Preschool ADHD-RS scores, parent and teacher rated scores on the Strength & Difficulties Questionnaire, direct observation of ADHD behaviors during Child’s Solo Play, observation of parent-child interaction, parent sense of competence, and family stress. Results will be reported using the standards set out in the Consolidated Standards of Reporting Trials Statement for Randomized Controlled Trials of nonpharmacological treatments. Conclusions The trial will provide evidence as to whether NFPP is a more effective treatment for preschool ADHD than the treatment usually offered in everyday clinical practice. Trial Registration ClinicalTrials.gov NCT01684644; https://clinicaltrials.gov/ct2/show/NCT01684644?term= NCT01684644&rank=1 (Archived by WebCite at http://www.webcitation/6eOOAe8Qe) PMID:27076496

A Randomized, Multicenter, Double-blind, Phase III Study to Evaluate the Efficacy on Allergic Rhinitis and Safety of a Combination Therapy of Montelukast and Levocetirizine in Patients With Asthma and Allergic Rhinitis.

PubMed

Kim, Mi-Kyeong; Lee, Sook Young; Park, Hae-Sim; Yoon, Ho Joo; Kim, Sang-Ha; Cho, Young Joo; Yoo, Kwang-Ha; Lee, Soo-Keol; Kim, Hee-Kyoo; Park, Jung-Won; Park, Heung-Woo; Chung, Jin-Hong; Choi, Byoung Whui; Lee, Byung-Jae; Chang, Yoon-Seok; Jo, Eun-Jung; Lee, Sang-Yeub; Cho, You Sook; Jee, Young-Koo; Lee, Jong-Myung; Jung, Jina; Park, Choon-Sik

2018-06-24

The aim of this study was to evaluate the efficacy and safety of a fixed-dose combination of montelukast and levocetirizine in patients with perennial allergic rhinitis with mild to moderate asthma compared with the efficacy and safety of montelukast alone. This study was a 4-week, randomized, multicenter, double-blind, Phase III trial. After a 1-week placebo run-in period, the subjects were randomized to receive montelukast (10mg/day, n = 112) or montelukast (10 mg/day)/levocetirizine (5 mg/day) (n = 116) treatment for 4 weeks. The primary efficacy end point was mean daytime nasal symptom score. Other efficacy end points included mean nighttime nasal symptom score, mean composite symptom score, overall assessment of allergic rhinitis by both subjects and physicians, forced expiratory volume in 1 second (FEV 1 ), forced vital capacity (FVC), FEV 1 /FVC, asthma control test score, and the frequency of rescue medication used during the treatment period. Of 333 patients screened for this study, 228 eligible patients were randomized to treatment. The mean (SD) age of patients was 43.32 (15.02) years, and two thirds of subjects were female (66.67%). The demographic characteristics were similar between the treatment groups. Compared with the montelukast group, the montelukast/levocetirizine group reported significant reductions in mean daytime nasal symptom score (least squares mean [SE] of combination vs montelukast, -0.98 [0.06] vs -0.81 [0.06]; P = 0.045). For all other allergic rhinitis efficacy end points, the montelukast/levocetirizine group showed greater improvement than the montelukast group. Similar results were observed in overall assessment scores and in FEV 1 , FVC, FEV 1 /FVC, and asthma control test score changes from baseline for the 2 treatment groups. Montelukast/levocetirizine was well tolerated, and the safety profile was similar to that observed in the montelukast group. The fixed-dose combination of montelukast and levocetirizine was effective and safe in treating perennial allergic rhinitis in patients with asthma compared with montelukast alone. ClinicalTrials.gov identifier: NCT02552667. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

NHash: Randomized N-Gram Hashing for Distributed Generation of Validatable Unique Study Identifiers in Multicenter Research.

PubMed

Zhang, Guo-Qiang; Tao, Shiqiang; Xing, Guangming; Mozes, Jeno; Zonjy, Bilal; Lhatoo, Samden D; Cui, Licong

2015-11-10

A unique study identifier serves as a key for linking research data about a study subject without revealing protected health information in the identifier. While sufficient for single-site and limited-scale studies, the use of common unique study identifiers has several drawbacks for large multicenter studies, where thousands of research participants may be recruited from multiple sites. An important property of study identifiers is error tolerance (or validatable), in that inadvertent editing mistakes during their transmission and use will most likely result in invalid study identifiers. This paper introduces a novel method called "Randomized N-gram Hashing (NHash)," for generating unique study identifiers in a distributed and validatable fashion, in multicenter research. NHash has a unique set of properties: (1) it is a pseudonym serving the purpose of linking research data about a study participant for research purposes; (2) it can be generated automatically in a completely distributed fashion with virtually no risk for identifier collision; (3) it incorporates a set of cryptographic hash functions based on N-grams, with a combination of additional encryption techniques such as a shift cipher; (d) it is validatable (error tolerant) in the sense that inadvertent edit errors will mostly result in invalid identifiers. NHash consists of 2 phases. First, an intermediate string using randomized N-gram hashing is generated. This string consists of a collection of N-gram hashes f1, f2, ..., fk. The input for each function fi has 3 components: a random number r, an integer n, and input data m. The result, fi(r, n, m), is an n-gram of m with a starting position s, which is computed as (r mod |m|), where |m| represents the length of m. The output for Step 1 is the concatenation of the sequence f1(r1, n1, m1), f2(r2, n2, m2), ..., fk(rk, nk, mk). In the second phase, the intermediate string generated in Phase 1 is encrypted using techniques such as shift cipher. The result of the encryption, concatenated with the random number r, is the final NHash study identifier. We performed experiments using a large synthesized dataset comparing NHash with random strings, and demonstrated neglegible probability for collision. We implemented NHash for the Center for SUDEP Research (CSR), a National Institute for Neurological Disorders and Stroke-funded Center Without Walls for Collaborative Research in the Epilepsies. This multicenter collaboration involves 14 institutions across the United States and Europe, bringing together extensive and diverse expertise to understand sudden unexpected death in epilepsy patients (SUDEP). The CSR Data Repository has successfully used NHash to link deidentified multimodal clinical data collected in participating CSR institutions, meeting all desired objectives of NHash.

Efficacy and safety of oral robenacoxib (tablet) for the treatment of pain associated with soft tissue surgery in client-owned dogs.

PubMed

Friton, Gabriele; Thompson, Caryn Marie; Karadzovska, Daniela; King, Stephen; King, Jonathan N

2017-06-26

Non-steroidal anti-inflammatory drugs (NSAIDs) have been proven to be effective in controlling peri-operative pain in dogs. Robenacoxib is an NSAID with high selectivity for the cyclooxygenase (COX)-2 isoform. The objective of this study was to assess the efficacy and safety of an oral tablet formulation of robenacoxib in client-owned dogs undergoing soft tissue surgery. The study was a prospective, multi-center, randomized, masked, placebo-controlled, parallel-group clinical trial. A total of 239 dogs were included and randomly allocated in a 1:1 ratio to receive either robenacoxib or placebo. Each dog received an oral tablet administration of either robenacoxib, at a target dose of 2 mg/kg, or placebo once prior to surgery and for two additional days post-operatively. All dogs also received a pre-anesthetic dose of 0.2 mg/kg butorphanol (intravenous or intramuscular). Pain assessments were performed using the short form of the Glasgow Composite Measure Pain Scale. Robenacoxib was compared to the placebo group on a success/failure basis. Treatment failure was defined as the need for rescue therapy to control post-operative pain. Significantly (P = 0.019) more dogs administered robenacoxib were considered treatment successes (89 of 116, 76.72%) compared to dogs given placebo (74 of 115, 64.35%). The percentage of treatment failure was therefore 23.28% in the robenacoxib and 35.65% in the placebo group. The least squares mean total pain scores were significantly different between groups and in favor of robenacoxib at 3 and 5 hours (P < 0.05) and 8 hours post-extubation (P < 0.01). Pain at the surgery sites (response to touch) was also significantly improved at 3, 5 and 8 hours post-extubation in dogs receiving robenacoxib versus placebo (P < 0.01). In addition, a significant overall improvement in posture/activity was revealed with robenacoxib having lower scores versus placebo (P < 0.01). No significant differences between the robenacoxib and placebo groups in the frequency of reported adverse events were observed. Robenacoxib by oral (tablet) administration was effective and well tolerated in the control of peri-operative pain and inflammation associated with soft tissue surgery in dogs.

Randomized trial of brinzolamide/brimonidine versus brinzolamide plus brimonidine for open-angle glaucoma or ocular hypertension.

PubMed

Gandolfi, Stefano A; Lim, John; Sanseau, Ana Cristina; Parra Restrepo, Juan Camilo; Hamacher, Thomas

2014-12-01

Fixed-combination intraocular pressure (IOP)-lowering medications simplify treatment regimens for patients requiring 2 ocular hypotensive agents to maintain sufficiently low IOP. The aim of this study was to evaluate the safety and efficacy of fixed-combination brinzolamide 1%/brimonidine 0.2% (BBFC) versus concomitant administration of brinzolamide 1% plus brimonidine 0.2% (BRINZ + BRIM) in patients with open-angle glaucoma or ocular hypertension. This was a prospective, phase 3, multicenter, double-masked, 6-month trial. Patients who had insufficient IOP control with monotherapy or who were receiving 2 IOP-lowering medications were randomized 1:1 to receive twice-daily BBFC or BRINZ + BRIM. IOP was assessed at 9 a.m. and 11 a.m. during week 2, week 6, month 3, and month 6 visits. The primary efficacy endpoint was mean diurnal IOP change from baseline to month 3; noninferiority was concluded if the upper limit of the 95% CI of the between-group difference was <1.5 mmHg. Supportive endpoints included mean IOP, IOP change from baseline, and percentage of patients with IOP <18 mmHg. Adverse events were recorded. The mean diurnal IOP change from baseline with BBFC (least squares mean ± standard error -8.5 ± 0.16 mmHg) was noninferior to that with BRINZ + BRIM (-8.3 ± 0.16 mmHg; mean difference -0.1 mmHg; 95% CI -0.5 to 0.2 mmHg). The upper limits of the 95% CIs were <1.5 mmHg at all time points. Decreases from baseline >8 mmHg were observed for least squares mean diurnal IOP in both groups as early as week 2 and continued to the end of the study. The results of all other supportive endpoints were similar to the primary efficacy endpoint. The most common ocular adverse drug reactions were hyperemia of the eye (reported as ocular or conjunctival hyperemia), visual disturbances, ocular allergic reactions, and ocular discomfort. Common systemic adverse drug reactions included dysgeusia, oral dryness, and fatigue/drowsiness. Brinzolamide 1%/brimonidine 0.2% fixed combination was as well tolerated and effective as concomitant therapy with its components. BBFC reduces treatment burden in patients who require multiple IOP-lowering medications.

Efficacy and Safety of Ranibizumab 0.5 mg for the Treatment of Macular Edema Resulting from Uncommon Causes: Twelve-Month Findings from PROMETHEUS.

PubMed

Staurenghi, Giovanni; Lai, Timothy Y Y; Mitchell, Paul; Wolf, Sebastian; Wenzel, Andreas; Li, Jun; Bhaumik, Amitabha; Hykin, Philip G

2018-06-01

To evaluate the efficacy and safety of ranibizumab 0.5 mg in adult patients with macular edema (ME) resulting from any cause other than diabetes, retinal vein occlusion, or neovascular age-related macular degeneration. A phase 3, 12-month, double-masked, randomized, sham-controlled, multicenter study. One hundred seventy-eight eligible patients aged ≥18 years. Patients were randomized 2:1 to receive either ranibizumab 0.5 mg (n = 118) or sham (n = 60) at baseline and month 1. From month 2, patients in both arms received open-label individualized ranibizumab treatment based on disease activity. A preplanned subgroup analysis was conducted on the primary end point on 5 predefined baseline ME etiologies (inflammatory/post-uveitis, pseudophakic or aphakic, central serous chorioretinopathy, idiopathic, and miscellaneous). Changes in best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study letters) from baseline to month 2 (primary end point) and month 12 and safety over 12 months. Overall, 156 patients (87.6%) completed the study. The baseline characteristics were well balanced between the treatment arms. Overall, ranibizumab showed superior efficacy versus sham from baseline to month 2 (least squares mean BCVA, +5.7 letters vs. +2.9 letters; 1-sided P = 0.0111), that is, a treatment effect (TE) of +2.8 letters. The mean BCVA gain from baseline to month 12 was 9.6 letters with ranibizumab. The TE at month 2 was variable in the 5 predefined etiology subgroups, ranging from >5-letter gain to 0.5-letter loss. The safety findings were consistent with the well-established safety profile of ranibizumab. The primary end point was met and ranibizumab showed superiority in BCVA gain over sham in treating ME due to uncommon causes, with a TE of +2.8 letters versus sham at month 2. At month 12, the mean BCVA gain was high (9.6 letters) in the ranibizumab arm; however, the TE was observed to be variable across the different etiology subgroups, reaching a >1-line TE in BCVA in patients with ME resulting from inflammatory conditions/post-uveitis or after cataract surgery. Overall, ranibizumab was well tolerated with no new safety findings up to month 12. Copyright © 2018 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Three-dimensional polarization marked multiple-QR code encryption by optimizing a single vectorial beam

NASA Astrophysics Data System (ADS)

Lin, Chao; Shen, Xueju; Hua, Binbin; Wang, Zhisong

2015-10-01

We demonstrate the feasibility of three dimensional (3D) polarization multiplexing by optimizing a single vectorial beam using a multiple-signal window multiple-plane (MSW-MP) phase retrieval algorithm. Original messages represented with multiple quick response (QR) codes are first partitioned into a series of subblocks. Then, each subblock is marked with a specific polarization state and randomly distributed in 3D space with both longitudinal and transversal adjustable freedoms. A generalized 3D polarization mapping protocol is established to generate a 3D polarization key. Finally, multiple-QR code is encrypted into one phase only mask and one polarization only mask based on the modified Gerchberg-Saxton (GS) algorithm. We take the polarization mask as the cyphertext and the phase only mask as additional dimension of key. Only when both the phase key and 3D polarization key are correct, original messages can be recovered. We verify our proposal with both simulation and experiment evidences.

A prospective randomized multicenter trial comparing clinical outcomes of patients treated surgically with a static or dynamic implant for acute ankle syndesmosis rupture.

PubMed

Laflamme, Mélissa; Belzile, Etienne L; Bédard, Luc; van den Bekerom, Michel P J; Glazebrook, Mark; Pelet, Stéphane

2015-05-01

To compare the clinical and radiographic outcome after stabilization of an acute syndesmosis rupture with either a static implant (a 3.5-mm metallic screw through 4 cortices) or a dynamic device (TightRope; Arthrex). Multicenter randomized double-blind controlled trial. Study realized in 5 trauma centers (2 level 1 and 3 level 2) in 2 countries. Seventy subjects admitted for an acute ankle syndesmosis rupture entered the study and were randomized into 2 groups (dynamic fixation = 34 and static fixation = 36). The 2 groups were similar regarding demographic, social, and surgical data. Sixty-five patients (dynamic = 33 and static = 32) completed the study and were available for analysis. Syndesmosis fixation in the static group was realized with a 4 cortices 3.5-mm cortical screw (Synthes) and in the dynamic group with 1 TightRope (Arthrex). Standardized rehabilitation process for the 2 groups: no weight bearing in a cast for 6 weeks and then rehabilitation without protection. Olerud-Molander score. Subjects with dynamic fixation achieved better clinical performances as described with the Olerud-Molander scores at 3 (68.8 vs. 60.2, P = 0.067), 6 (84.2 vs. 76.8, P = 0.082), and 12 months (93.3 vs. 87.6, P = 0.046). We also observed higher American Orthopaedic Foot and Ankle Society scores at 3 months (78.6 vs. 70.6, P = 0.016), but these were not significant at 6 (87.1 vs. 83.8, P = 0.26) or 12 months (93.1 vs. 89.9, P = 0.26). Implant failure was higher in the screw group (36.1% vs. 0%, P < 0.05). Loss of reduction was observed in 4 cases in the static screw group (11.1% vs. 0%, P = 0.06). Dynamic fixation of acute ankle syndesmosis rupture with a dynamic device seems to result in better clinical and radiographic outcomes. The implant offers adequate syndesmotic stabilization without failure or loss of reduction, and the reoperation rate is significantly lower than with conventional screw fixation. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Development of Personalized Fitting Device With 3-Dimensional Solution for Prevention of NIV Oronasal Mask-Related Pressure Ulcers.

PubMed

Shikama, Maiko; Nakagami, Gojiro; Noguchi, Hiroshi; Mori, Taketoshi; Sanada, Hiromi

2018-05-22

Pressure ulcers related to oronasal masks used with noninvasive ventilation (NIV), along with patient discomfort, occur due to improper fit of the mask. We developed a personalized fitting device using a 3-dimensional (3D) scanning solution to prevent the formation of NIV mask-related pressure ulcers. This study aimed to evaluate the effectiveness of the proposed personalized fitting device. We conducted a randomized crossover experimental study of 20 healthy participants to study the use of this personalized fitting device between the face and an NIV mask designed with 3D solutions. The fitting device was not used under the NIV mask for the control. The outcome measures were the presence of blanchable erythema, standardized redness intensity, discomfort level, and contact pressure. The incidence of blanchable erythema and standardized redness intensity values were significantly lower for subjects who used the fitting device when worn for 30 min ( P < .001). The discomfort levels at the forehead, nasal bridge, and both cheeks, as well as leakage, were significantly reduced as well ( P = .008, P < .001, P = .001, P = .002, P = .001, P = .02, P < .001, P < .001, P < .001). Contact pressure at the nasal bridge, where pressure ulcers most frequently develop, was significantly decreased with the fitting device ( P < .001). Personalized fitting devices that incorporate 3D scanning solutions may contribute to the prevention of NIV mask-related pressure ulcers and the reduction of discomfort. Copyright © 2018 by Daedalus Enterprises.

Quantification of mammographic masking risk with volumetric breast density maps: how to select women for supplemental screening

NASA Astrophysics Data System (ADS)

Holland, Katharina; van Gils, Carla H.; Wanders, Johanna OP; Mann, Ritse M.; Karssemeijer, Nico

2016-03-01

The sensitivity of mammograms is low for women with dense breasts, since cancers may be masked by dense tissue. In this study, we investigated methods to identify women with density patterns associated with a high masking risk. Risk measures are derived from volumetric breast density maps. We used the last negative screening mammograms of 93 women who subsequently presented with an interval cancer (IC), and, as controls, 930 randomly selected normal screening exams from women without cancer. Volumetric breast density maps were computed from the mammograms, which provide the dense tissue thickness at each location. These were used to compute absolute and percentage glandular tissue volume. We modeled the masking risk for each pixel location using the absolute and percentage dense tissue thickness and we investigated the effect of taking the cancer location probability distribution (CLPD) into account. For each method, we selected cases with the highest masking measure (by thresholding) and computed the fraction of ICs as a function of the fraction of controls selected. The latter can be interpreted as the negative supplemental screening rate (NSSR). Between the models, when incorporating CLPD, no significant differences were found. In general, the methods performed better when CLPD was included. At higher NSSRs some of the investigated masking measures had a significantly higher performance than volumetric breast density. These measures may therefore serve as an alternative to identify women with a high risk for a masked cancer.

Do little interactions get lost in dark random forests?

PubMed

Wright, Marvin N; Ziegler, Andreas; König, Inke R

2016-03-31

Random forests have often been claimed to uncover interaction effects. However, if and how interaction effects can be differentiated from marginal effects remains unclear. In extensive simulation studies, we investigate whether random forest variable importance measures capture or detect gene-gene interactions. With capturing interactions, we define the ability to identify a variable that acts through an interaction with another one, while detection is the ability to identify an interaction effect as such. Of the single importance measures, the Gini importance captured interaction effects in most of the simulated scenarios, however, they were masked by marginal effects in other variables. With the permutation importance, the proportion of captured interactions was lower in all cases. Pairwise importance measures performed about equal, with a slight advantage for the joint variable importance method. However, the overall fraction of detected interactions was low. In almost all scenarios the detection fraction in a model with only marginal effects was larger than in a model with an interaction effect only. Random forests are generally capable of capturing gene-gene interactions, but current variable importance measures are unable to detect them as interactions. In most of the cases, interactions are masked by marginal effects and interactions cannot be differentiated from marginal effects. Consequently, caution is warranted when claiming that random forests uncover interactions.

Striking the balance: Privacy and spatial pattern preservation in masked GPS data

NASA Astrophysics Data System (ADS)

Seidl, Dara E.

Volunteered location and trajectory data are increasingly collected and applied in analysis for a variety of academic fields and recreational pursuits. As access to personal location data increases, issues of privacy arise as individuals become identifiable and linked to other repositories of information. While the quality and precision of data are essential to accurate analysis, there is a tradeoff between privacy and access to data. Obfuscation of point data is a solution that aims to protect privacy and maximize preservation of spatial pattern. This study explores two methods of location obfuscation for volunteered GPS data: grid masking and random perturbation. These methods are applied to travel survey GPS data in the greater metropolitan regions of Chicago and Atlanta in the first large-scale GPS masking study of its kind.

VizieR Online Data Catalog: Radial velocities of galaxies in A523 field (Girardi+, 2016)

NASA Astrophysics Data System (ADS)

Girardi, M.; Boschin, W.; Gastaldello, F.; Giovannini, G.; Govoni, F.; Murgia, M.; Barrena, R.; Ettori, S.; Trasatti, M.; Vacca, V.

2016-09-01

Multi-object spectroscopic observations of A523 were carried out at the TNG in 2012 December and 2014 January. We used the instrument DOLORES in MOS mode with the LR-B Grism. In summary, we observed six MOS masks for a total of 210 slits. The total exposure time was 3600s for three masks, 5400s for two masks and 7200s for the last one. Our photometric observations were carried out with the Wide Field Camera (WFC), mounted at the prime focus of the 2.5-m INT telescope. We observed A523 in g, r and i Sloan-Gunn filters in photometric conditions and a seeing of ~1.4arcsec. (1 data file).

PEEP-masks in patients with severe obstructive pulmonary disease: a negative report.

PubMed

Christensen, H R; Simonsen, K; Lange, P; Clementsen, P; Kampmann, J P; Viskum, K; Heideby, J; Koch, U

1990-03-01

Positive pressure during expiration by face masks applied by the patient has gained wide acceptance in the treatment of chronic bronchitis, but the efficacy is still unproven. The effect of 6 months of treatment with PEEP-masks (positive end-expiratory pressure) was therefore studied in 47 patients with severe irreversible obstructive pulmonary disease (forced expiratory volume in one second (FEV1) about 1 l), and mucus hypersecretion. Patients were double-blindly randomized to at least 45 min daily treatment with PEEP-masks with either 10 or 0 cm water pressure. After 6 months of treatment, no statistical difference was found between the two groups in change of median values (month 6 - month 0) of FEV1, forced vital capacity (FVC), arterial oxygen tension (PaO2), amount of sputum or dyspnoea. Median values of arterial carbon dioxide tension (PaCO2) decreased significantly (0.03 kPa) in the placebo group. Cough intensity and dyspnoea during walking on staircases improved significantly in the placebo group. No difference among groups was found in number of days bedridden, hospitalized, number of exacerbations or antibiotic consumption. We conclude, that the use of PEEP-masks in these patients is without clinical documentation and cannot be recommended.

Comparative habitat ecology of Texas and masked bobwhites

USGS Publications Warehouse

Guthery, F.S.; King, N.M.; Nolte, K.R.; Kuvlesky, W.P.; DeStefano, S.; Gall, S.A.; Silvy, N.J.

2000-01-01

The habitat ecology of masked bobwhites (Colinus virginianus ridgwayi) is poorly understood, which hampers recovery efforts for this endangered bird. During 1994-96, we analyzed the habitat ecology of masked bobwhites in Sonora, Mexico, and Arizona, and compared these findings with the habitat ecology of Texas bobwhites (C. v. texanus) in southern Texas. Mean values for the quantity of low screening cover (<50 cm aboveground), operative temperature (??C), and exposure to aerial predators were relatively constant across regions (CV <14.2%), indicating these variables are important in adaptive habitat-use decisions by bobwhites. Bobwhites exhibited preference in all regions for higher canopy coverage of woody vegetation, lower exposure to aerial predators, and lower operative temperatures in comparison with randomly available conditions. The major habitat deficiencies for masked bobwhites were lack of woody and herbaceous cover, which led to high exposure to aerial predators in Sonora and Arizona. High operative temperatures at quail level were associated with the loss of ???24% of potential habitat space-time in Texas, Sonora, and Arizona. Management to improve habitat for masked bobwhites includes any practice that increases canopy coverage of woody vegetation, and height and coverage of herbaceous vegetation.

Study of shape evaluation for mask and silicon using large field of view

NASA Astrophysics Data System (ADS)

Matsuoka, Ryoichi; Mito, Hiroaki; Shinoda, Shinichi; Toyoda, Yasutaka

2010-09-01

We have developed a highly integrated method of mask and silicon metrology. The aim of this integration is evaluating the performance of the silicon corresponding to Hotspot on a mask. It can use the mask shape of a large field, besides. The method adopts a metrology management system based on DBM (Design Based Metrology). This is the high accurate contouring created by an edge detection algorithm used in mask CD-SEM and silicon CD-SEM. Currently, as semiconductor manufacture moves towards even smaller feature size, this necessitates more aggressive optical proximity correction (OPC) to drive the super-resolution technology (RET). In other words, there is a trade-off between highly precise RET and mask manufacture, and this has a big impact on the semiconductor market that centers on the mask business. As an optimal solution to these issues, we provide a DFM solution that extracts 2-dimensional data for a more realistic and error-free simulation by reproducing accurately the contour of the actual mask, in addition to the simulation results from the mask data. On the other hand, there is roughness in the silicon form made from a mass-production line. Moreover, there is variation in the silicon form. For this reason, quantification of silicon form is important, in order to estimate the performance of a pattern. In order to quantify, the same form is equalized in two dimensions. And the method of evaluating based on the form is popular. In this study, we conducted experiments for averaging method of the pattern (Measurement Based Contouring) as two-dimensional mask and silicon evaluation technique. That is, observation of the identical position of a mask and a silicon was considered. The result proved its detection accuracy and reliability of variability on two-dimensional pattern (mask and silicon) and is adaptable to following fields of mask quality management. •Discrimination of nuisance defects for fine pattern. •Determination of two-dimensional variability of pattern. •Verification of the performance of the pattern of various kinds of Hotspots. In this report, we introduce the experimental results and the application. We expect that the mask measurement and the shape control on mask production will make a huge contribution to mask yield-enhancement and that the DFM solution for mask quality control process will become much more important technology than ever. It is very important to observe the form of the same location of Design, Mask, and Silicon in such a viewpoint. And we report it about algorithm of the image composition in Large Field.

[A comparison of various supraglottic airway devices for fiberoptical guided tracheal intubation].

PubMed

Metterlein, Thomas; Dintenfelder, Anna; Plank, Christoph; Graf, Bernhard; Roth, Gabriel

Fiberoptical assisted intubation via placed supraglottic airway devices has been described as safe and easy procedure to manage difficult airways. However visualization of the glottis aperture is essential for fiberoptical assisted intubation. Various different supraglottic airway devices are commercially available and might offer different conditions for fiberoptical assisted intubation. The aim of this study was to compare the best obtainable view of the glottic aperture using different supraglottic airway devices. With approval of the local ethics committee 52 adult patients undergoing elective anesthesia were randomly assigned to a supraglottic airway device (Laryngeal Tube, Laryngeal Mask Airway I-Gel, Laryngeal Mask Airway Unique, Laryngeal Mask Airway Supreme, Laryngeal Mask Airway Aura-once). After standardized induction of anaesthesia the supraglottic airway device was placed according to the manufacturers recommendations. After successful ventilation the position of the supraglottic airway device in regard to the glottic opening was examined with a flexible fiberscope. A fully or partially visible glottic aperture was considered as suitable for fiberoptical assisted intubation. Suitability for fiberoptical assisted intubation was compared between the groups (H-test, U-test; p<0.05). Demographic data was not different between the groups. Placement of the supraglottic airway device and adequate ventilation was successful in all attempts. Glottic view suitable for fiberoptical assisted intubation differed between the devices ranging from 40% for the laringeal tube (LT), 66% for the laryngeal mask airway Supreme, 70% for the Laryngeal Mask Airway I-Gel and 90% for both the Laryngeal Mask Airway Unique and the Laryngeal Mask Airway Aura-once. None of the used supraglottic airway devices offered a full or partial glottic view in all cases. However the Laryngeal Mask Airway Unique and the Laryngeal Mask Airway Aura-once seem to be more suitable for fiberoptical assisted intubation compared to other devices. Copyright © 2016 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

A comparison of various supraglottic airway devices for fiberoptical guided tracheal intubation.

PubMed

Metterlein, Thomas; Dintenfelder, Anna; Plank, Christoph; Graf, Bernhard; Roth, Gabriel

Fiberoptical assisted intubation via placed supraglottic airway devices has been described as safe and easy procedure to manage difficult airways. However visualization of the glottis aperture is essential for fiberoptical assisted intubation. Various different supraglottic airway devices are commercially available and might offer different conditions for fiberoptical assisted intubation. The aim of this study was to compare the best obtainable view of the glottic aperture using different supraglottic airway devices. With approval of the local ethics committee 52 adult patients undergoing elective anesthesia were randomly assigned to a supraglottic airway device (Laryngeal Tube, Laryngeal Mask Airway I-Gel, Laryngeal Mask Airway Unique, Laryngeal Mask Airway Supreme, Laryngeal Mask Airway Aura-once). After standardized induction of anesthesia the supraglottic airway device was placed according to the manufacturers recommendations. After successful ventilation the position of the supraglottic airway device in regard to the glottic opening was examined with a flexible fiberscope. A fully or partially visible glottic aperture was considered as suitable for fiberoptical assisted intubation. Suitability for fiberoptical assisted intubation was compared between the groups (H-test, U-test; p<0.05). Demographic data was not different between the groups. Placement of the supraglottic airway device and adequate ventilation was successful in all attempts. Glottic view suitable for fiberoptical assisted intubation differed between the devices ranging from 40% for the laringeal tube (LT), 66% for the laryngeal mask airway Supreme, 70% for the Laryngeal Mask Airway I-Gel and 90% for both the Laryngeal Mask Airway Unique and the Laryngeal Mask Airway Aura-once. None of the used supraglottic airway devices offered a full or partial glottic view in all cases. However the Laryngeal Mask Airway Unique and the Laryngeal Mask Airway Aura-once seem to be more suitable for fiberoptical assisted intubation compared to other devices. Copyright © 2016 Sociedade Brasileira de Anestesiologia. Published by Elsevier Editora Ltda. All rights reserved.

Oral mask ventilation is more effective than face mask ventilation after nasal surgery.

PubMed

Yazicioğlu, Dilek; Baran, Ilkay; Uzumcugil, Filiz; Ozturk, Ibrahim; Utebey, Gulten; Sayın, M Murat

2016-06-01

To evaluate and compare the face mask (FM) and oral mask (OM) ventilation techniques during anesthesia emergence regarding tidal volume, leak volume, and difficult mask ventilation (DMV) incidence. Prospective, randomized, crossover study. Operating room, training and research hospital. American Society of Anesthesiologists physical status I and II adult patients scheduled for nasal surgery. Patients in group FM-OM received FM ventilation first, followed by OM ventilation, and patients in group OM-FM received OM ventilation first, followed by FM ventilation, with spontaneous ventilation after deep extubation. The FM ventilation was applied with the 1-handed EC-clamp technique. The OM was placed only over the mouth, and the 1-handed EC-clamp technique was used again. A child's size FM was used for the OM ventilation technique, the mask was rotated, and the inferior part of the mask was placed toward the nose. The leak volume (MVleak), mean airway pressure (Pmean), and expired tidal volume (TVe) were assessed with each mask technique for 3 consecutive breaths. A mask ventilation grade ≥3 was considered DMV. DMV occurred more frequently during FM ventilation (75% with FM vs 8% with OM). In the FM-first sequence, the mean TVe was 249±61mL with the FM and 455±35mL with the OM (P=.0001), whereas in the OM-first sequence, it was 276±81mL with the FM and 409±37mL with the OM (P=.0001). Regardless of the order used, the OM technique significantly decreased the MVleak and increased the TVe when compared to the FM technique. During anesthesia emergence after nasal surgery the OM may offer an effective ventilation method as it decreases the incidence of DMV and the gas leak around the mask and provides higher tidal volume delivery compared with FM ventilation. Copyright © 2016 Elsevier Inc. All rights reserved.

A multicenter, randomized, controlled clinical trial evaluating the use of dehydrated human amnion/chorion membrane allografts and multilayer compression therapy vs. multilayer compression therapy alone in the treatment of venous leg ulcers.

PubMed

Serena, Thomas E; Carter, Marissa J; Le, Lam T; Sabo, Matthew J; DiMarco, Daniel T

2014-01-01

Venous leg ulcers produce significant clinical and economic burdens on society and often require advanced wound therapy. The purpose of this multicenter, randomized, controlled study is to evaluate the safety and efficacy of one or two applications of dehydrated human amnion/chorion membrane allograft and multilayer compression therapy vs. multilayer compression therapy alone in the treatment of venous leg ulcers. The primary study outcome was the proportion of patients achieving 40% wound closure at 4 weeks. Of the 84 participants enrolled, 53 were randomized to receive allograft and 31 were randomized to the control group of multilayer compression therapy alone. At 4 weeks, 62% in the allograft group and 32% in the control group showed a greater than 40% wound closure (p = 0.005), thus showing a significant difference between the allograft-treated groups and the multilayer compression therapy alone group at the 4-week surrogate endpoint. After 4 weeks, wounds treated with allograft had reduced in size a mean of 48.1% compared with 19.0% for controls. Venous leg ulcers treated with allograft had a significant improvement in healing at 4 weeks compared with multilayer compression therapy alone. © 2014 by the Wound Healing Society.

Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery.

PubMed

Hemmes, Sabrine N T; Severgnini, Paolo; Jaber, Samir; Canet, Jaume; Wrigge, Hermann; Hiesmayr, Michael; Tschernko, Edda M; Hollmann, Markus W; Binnekade, Jan M; Hedenstierna, Göran; Putensen, Christian; de Abreu, Marcelo Gama; Pelosi, Paolo; Schultz, Marcus J

2011-05-06

Post-operative pulmonary complications add to the morbidity and mortality of surgical patients, in particular after general anesthesia >2 hours for abdominal surgery. Whether a protective mechanical ventilation strategy with higher levels of positive end-expiratory pressure (PEEP) and repeated recruitment maneuvers; the "open lung strategy", protects against post-operative pulmonary complications is uncertain. The present study aims at comparing a protective mechanical ventilation strategy with a conventional mechanical ventilation strategy during general anesthesia for abdominal non-laparoscopic surgery. The PROtective Ventilation using HIgh versus LOw positive end-expiratory pressure ("PROVHILO") trial is a worldwide investigator-initiated multicenter randomized controlled two-arm study. Nine hundred patients scheduled for non-laparoscopic abdominal surgery at high or intermediate risk for post-operative pulmonary complications are randomized to mechanical ventilation with the level of PEEP at 12 cmH(2)O with recruitment maneuvers (the lung-protective strategy) or mechanical ventilation with the level of PEEP at maximum 2 cmH(2)O without recruitment maneuvers (the conventional strategy). The primary endpoint is any post-operative pulmonary complication. The PROVHILO trial is the first randomized controlled trial powered to investigate whether an open lung mechanical ventilation strategy in short-term mechanical ventilation prevents against postoperative pulmonary complications. ISRCTN: ISRCTN70332574.

Evaluating the use of fibrin glue for sealing low-output enterocutaneous fistulas: study protocol for a randomized controlled trial.

PubMed

Wu, Xiuwen; Ren, Jianan; Wang, Gefei; Wang, Jianzhong; Wang, Feng; Fan, Yueping; Li, Yuanxin; Han, Gang; Zhou, Yanbing; Song, Xiaofei; Quan, Bin; Yao, Min; Li, Jieshou

2015-10-07

The management of an enterocutaneous fistula poses a significant challenge to surgeons and is often associated with a costly hospital stay and long-term discomfort. The use of fibrin glue in the fistula tract has been shown to promote closure of low output enterocutaneous fistulas. Our previous nonrandomized study demonstrated that autologous platelet-rich fibrin glue treatment significantly decreased time to fistula closure and promoted closure rates. However, there are several limitations in the study, which may lead to bias in our conclusion. Thus, a multicenter, randomized, controlled clinical trial is required. The study is designed as a randomized, open-label, three-arm, multicenter study in nine Chinese academic hospitals for evaluating the efficacy and safety of fibrin glue for sealing low-output fistulas. An established number of 171 fistula patients will undergo prospective random assignment to autologous fibrin glue, commercial porcine fibrin sealants or drainage cessation (1:1:1). The primary endpoint is fistula closure time (defined as the interval between the day of enrollment and day of fistula closure) during the 14-day treatment period. To our knowledge, this is the first study to evaluate the safety and efficacy of both autologous and commercial fibrin glue sealing for patients with low-output volume fistulas. NCT01828892 . Registration date: April 2013.

Modelling exoplanet detection with the LUVOIR Coronagraph: aberration sensitivity and error tolerances

NASA Astrophysics Data System (ADS)

Juanola-Parramon, Roser; Zimmerman, Neil; Bolcar, Matthew R.; Rizzo, Maxime; Roberge, Aki

2018-01-01

The Coronagraph is a key instrument on the Large UV-Optical-Infrared (LUVOIR) Surveyor mission concept. The Apodized Pupil Lyot Coronagraph (APLC) is one of the baselined mask technologies to enable 1E10 contrast observations in the habitable zones of nearby stars. Both the LUVOIR architectures A and B present a segmented aperture as input pupil, introducing a set of random tip/tilt and piston errors, among others, that greatly affect the performance of the coronagraph instrument by increasing the wavefront errors hence reducing the instrument sensitivity. In this poster we present the latest results of the simulation of these effects for different working angle regions and discuss the achieved contrast for exoplanet detection and characterization, including simulated observations under these circumstances, setting boundaries for the tolerance of such errors.

My Other Half Manifested in Mask-Making

ERIC Educational Resources Information Center

Abel, Xanthippi

2010-01-01

Every fall season, each grade level of Rowland Hall St. Mark's Lower School in Salt Lake City, Utah, completes a mask-making project to be featured in a schoolwide parade. This sparked an opportunity to incorporate the fourth-grade unit of realistic and observational drawing with mask making. In this article, the author describes how her students…

Treatment in carbon monoxide poisoning patients with headache: a prospective, multicenter, double-blind, controlled clinical trial.

PubMed

Ocak, Tarik; Tekin, Erdal; Basturk, Mustafa; Duran, Arif; Serinken, Mustafa; Emet, Mucahit

2016-11-01

There is a lack of specificity of the analgesic agents used to treat headache and underlying acute carbon monoxide poisoning. To compare effectiveness of "oxygen alone" vs "metoclopramide plus oxygen" vs "metamizole plus oxygen" therapy in treating carbon monoxide-induced headache. A prospective, multicenter, double-blind, controlled trial. Three emergency departments in Turkey. Adult carbon monoxide poisoning patients with headache. A total of 117 carbon monoxide-intoxicated patients with headache were randomized into 3 groups and assessed at baseline, 30 minutes, 90 minutes, and 4 hours. The primary outcome was patient-reported improvement rates for headache. Secondary end points included nausea, need for rescue medication during treatment, and reduction in carboxyhemoglobin levels. During observation, there was no statistical difference between drug type and visual analog scale score change at 30 minutes, 90 minutes, or 4 hours, for either headache or nausea. No rescue medication was needed during the study period. The reduction in carboxyhemoglobin levels did not differ among the 3 groups. The use of "oxygen alone" is as efficacious as "oxygen plus metoclopramide" or "oxygen plus metamizole sodium" in the treatment of carbon monoxide-induced headache. Copyright © 2016 Elsevier Inc. All rights reserved.

Collinear masking effect in visual search is independent of perceptual salience.

PubMed

Jingling, Li; Lu, Yi-Hui; Cheng, Miao; Tseng, Chia-Huei

2017-07-01

Searching for a target in a salient region should be easier than looking for one in a nonsalient region. However, we previously discovered a contradictory phenomenon in which a local target in a salient structure was more difficult to find than one in the background. The salient structure was constructed of orientation singletons aligned to each other to form a collinear structure. In the present study, we undertake to determine whether such a masking effect was a result of salience competition between a global structure and the local target. In the first 3 experiments, we increased the salience value of the local target with the hope of adding to its competitive advantage and eventually eliminating the masking effect; nevertheless, the masking effect persisted. In an additional 2 experiments, we reduced salience of the global collinear structure by altering the orientation of the background bars and the masking effect still emerged. Our salience manipulations were validated by a controlled condition in which the global structure was grouped noncollinearly. In this case, local target salience increase (e.g., onset) or global distractor salience reduction (e.g., randomized flanking orientations) effectively removed the facilitation effect of the noncollinear structure. Our data suggest that salience competition is unlikely to explain the collinear masking effect, and other mechanisms such as contour integration, border formation, or the crowding effect may be prospective candidates for further investigation.

Adaptation to different noninvasive ventilation masks in critically ill patients*

PubMed Central

da Silva, Renata Matos; Timenetsky, Karina Tavares; Neves, Renata Cristina Miranda; Shigemichi, Liane Hirano; Kanda, Sandra Sayuri; Maekawa, Carla; Silva, Eliezer; Eid, Raquel Afonso Caserta

2013-01-01

OBJECTIVE: To identify which noninvasive ventilation (NIV) masks are most commonly used and the problems related to the adaptation to such masks in critically ill patients admitted to a hospital in the city of São Paulo, Brazil. METHODS: An observational study involving patients ≥ 18 years of age admitted to intensive care units and submitted to NIV. The reason for NIV use, type of mask, NIV regimen, adaptation to the mask, and reasons for non-adaptation to the mask were investigated. RESULTS: We evaluated 245 patients, with a median age of 82 years. Acute respiratory failure was the most common reason for NIV use (in 71.3%). Total face masks were the most commonly used (in 74.7%), followed by full face masks and near-total face masks (in 24.5% and 0.8%, respectively). Intermittent NIV was used in 82.4% of the patients. Adequate adaptation to the mask was found in 76% of the patients. Masks had to be replaced by another type of mask in 24% of the patients. Adequate adaptation to total face masks and full face masks was found in 75.5% and 80.0% of the patients, respectively. Non-adaptation occurred in the 2 patients using near-total facial masks. The most common reason for non-adaptation was the shape of the face, in 30.5% of the patients. CONCLUSIONS: In our sample, acute respiratory failure was the most common reason for NIV use, and total face masks were the most commonly used. The most common reason for non-adaptation to the mask was the shape of the face, which was resolved by changing the type of mask employed. PMID:24068269

Adaptation to different noninvasive ventilation masks in critically ill patients.

PubMed

Silva, Renata Matos da; Timenetsky, Karina Tavares; Neves, Renata Cristina Miranda; Shigemichi, Liane Hirano; Kanda, Sandra Sayuri; Maekawa, Carla; Silva, Eliezer; Eid, Raquel Afonso Caserta

2013-01-01

To identify which noninvasive ventilation (NIV) masks are most commonly used and the problems related to the adaptation to such masks in critically ill patients admitted to a hospital in the city of São Paulo, Brazil. An observational study involving patients ≥ 18 years of age admitted to intensive care units and submitted to NIV. The reason for NIV use, type of mask, NIV regimen, adaptation to the mask, and reasons for non-adaptation to the mask were investigated. We evaluated 245 patients, with a median age of 82 years. Acute respiratory failure was the most common reason for NIV use (in 71.3%). Total face masks were the most commonly used (in 74.7%), followed by full face masks and near-total face masks (in 24.5% and 0.8%, respectively). Intermittent NIV was used in 82.4% of the patients. Adequate adaptation to the mask was found in 76% of the patients. Masks had to be replaced by another type of mask in 24% of the patients. Adequate adaptation to total face masks and full face masks was found in 75.5% and 80.0% of the patients, respectively. Non-adaptation occurred in the 2 patients using near-total facial masks. The most common reason for non-adaptation was the shape of the face, in 30.5% of the patients. In our sample, acute respiratory failure was the most common reason for NIV use, and total face masks were the most commonly used. The most common reason for non-adaptation to the mask was the shape of the face, which was resolved by changing the type of mask employed.

Lateralization of kin recognition signals in the human face

PubMed Central

Dal Martello, Maria F.; Maloney, Laurence T.

2010-01-01

When human subjects view photographs of faces, their judgments of identity, gender, emotion, age, and attractiveness depend more on one side of the face than the other. We report an experiment testing whether allocentric kin recognition (the ability to judge the degree of kinship between individuals other than the observer) is also lateralized. One hundred and twenty-four observers judged whether or not pairs of children were biological siblings by looking at photographs of their faces. In three separate conditions, (1) the right hemi-face was masked, (2) the left hemi-face was masked, or (3) the face was fully visible. The d′ measures for the masked left hemi-face and masked right hemi-face were 1.024 and 1.004, respectively (no significant difference), and the d′ measure for the unmasked face was 1.079, not significantly greater than that for either of the masked conditions. We conclude, first, that there is no superiority of one or the other side of the observed face in kin recognition, second, that the information present in the left and right hemi-faces relevant to recognizing kin is completely redundant, and last that symmetry cues are not used for kin recognition. PMID:20884584

Modeling and Observations of Phase-Mask Trapezoidal Profiles with Grating-Fiber Image Reproduction

NASA Technical Reports Server (NTRS)

Lyons, Donald R.; Lindesay, James V.; Lee, Hyung R.; Ndlela, Zolili U.; Thompso, Erica J.

2000-01-01

We report on an investigation of the trapezoidal design and fabrication defects in phase masks used to produce Bragg reflection gratings in optical fibers. We used a direct visualization technique to examine the nonuniformity of the interference patterns generated by several phase masks. Fringe patterns from the phase masks are compared with the analogous patterns resulting from two-beam interference. Atomic force microscope imaging of the actual phase gratings that give rise to anomalous fringe patterns is used to determine input parameters for a general theoretical model. Phase masks with pitches of 0.566 and 1.059 microns are modeled and investigated.

How color, regularity, and good Gestalt determine backward masking.

PubMed

Sayim, Bilge; Manassi, Mauro; Herzog, Michael

2014-06-18

The strength of visual backward masking depends on the stimulus onset asynchrony (SOA) between target and mask. Recently, it was shown that the conjoint spatial layout of target and mask is as crucial as SOA. Particularly, masking strength depends on whether target and mask group with each other. The same is true in crowding where the global spatial layout of the flankers and target-flanker grouping determine crowding strength. Here, we presented a vernier target followed by different flanker configurations at varying SOAs. Similar to crowding, masking of a red vernier target was strongly reduced for arrays of 10 green compared with 10 red flanking lines. Unlike crowding, single green lines flanking the red vernier showed strong masking. Irregularly arranged flanking lines yielded stronger masking than did regularly arranged lines, again similar to crowding. While cuboid flankers reduced crowding compared with single lines, this was not the case in masking. We propose that, first, masking is reduced when the flankers are part of a larger spatial structure. Second, spatial factors counteract color differences between the target and the flankers. Third, complex Gestalts, such as cuboids, seem to need longer processing times to show ungrouping effects as observed in crowding. Strong parallels between masking and crowding suggest similar underlying mechanism; however, temporal factors in masking additionally modulate performance, acting as an additional grouping cue. © 2014 ARVO.

SatCam: A mobile application for coordinated ground/satellite observation of clouds and validation of satellite-derived cloud mask products.

NASA Astrophysics Data System (ADS)

Gumley, L.; Parker, D.; Flynn, B.; Holz, R.; Marais, W.

2011-12-01

SatCam is an application for iOS devices that allows users to collect observations of local cloud and surface conditions in coordination with an overpass of the Terra, Aqua, or NPP satellites. SatCam allows users to acquire images of sky conditions and ground conditions at their location anywhere in the world using the built-in iPhone or iPod Touch camera at the same time that the satellite is passing overhead and viewing their location. Immediately after the sky and ground observations are acquired, the application asks the user to rate the level of cloudiness in the sky (Completely Clear, Mostly Clear, Partly Cloudy, Overcast). For the ground observation, the user selects their assessment of the surface conditions (Urban, Green Vegetation, Brown Vegetation, Desert, Snow, Water). The sky condition and surface condition selections are stored along with the date, time, and geographic location for the images, and the images are uploaded to a central server. When the MODIS (Terra and Aqua) or VIIRS (NPP) imagery acquired over the user location becomes available, a MODIS or VIIRS true color image centered at the user's location is delivered back to the SatCam application on the user's iOS device. SSEC also proposes to develop a community driven SatCam website where users can share their observations and assessments of satellite cloud products in a collaborative environment. SSEC is developing a server side data analysis system to ingest the SatCam user observations, apply quality control, analyze the sky images for cloud cover, and collocate the observations with MODIS and VIIRS satellite products (e.g., cloud mask). For each observation that is collocated with a satellite observation, the server will determine whether the user scored a "hit", meaning their sky observation and sky assessment matched the automated cloud mask obtained from the satellite observation. The hit rate will be an objective assessment of the accuracy of the user's sky observations. Users with high hit rates will be identified automatically and their observations will be used globally to evaluate the performance of the MODIS cloud mask algorithm for Terra and Aqua and the VIIRS cloud mask algorithm for NPP. The user's assessment of the ground conditions will also be used to evaluate the cloud mask accuracy in selecting the correct surface type at the user's location, which is an important element in the decision path used internally by the cloud mask algorithm. This presentation will describe the SatCam application, how it is used, and show examples of SatCam observations.

Comparative effectiveness and cost-effectiveness of Chuna manual therapy versus conventional usual care for nonacute low back pain: study protocol for a pilot multicenter, pragmatic randomized controlled trial (pCRN study).

PubMed

Shin, Byung-Cheul; Kim, Me-Riong; Cho, Jae-Heung; Jung, Jae-Young; Kim, Koh-Woon; Lee, Jun-Hwan; Nam, Kibong; Lee, Min Ho; Hwang, Eui-Hyoung; Heo, Kwang-Ho; Kim, Namkwen; Ha, In-Hyuk

2017-01-17

While Chuna manual therapy is a Korean manual therapy widely used primarily for low back pain (LBP)-related disorders in Korea, well-designed studies on the comparative effectiveness of Chuna manual therapy are scarce. This study is the protocol for a three-armed, multicenter, pragmatic randomized controlled pilot trial. Sixty severe nonacute LBP patients (pain duration of at least 3 weeks, Numeric Rating Scale (NRS) ≥5) will be recruited at four Korean medicine hospitals. Participants will be randomly allocated to the Chuna group (n = 20), usual care group (n = 20), or Chuna plus usual care group (n = 20) for 6 weeks of treatment. Usual care will consist of orally administered conventional medicine, physical therapy, and back pain care education. The trial will be conducted with outcome assessor and statistician blinding. The primary endpoint will be NRS of LBP at week 7 post randomization. Secondary outcomes include NRS of leg pain, the Oswestry Disability Index (ODI), the Patient Global Impression of Change (PGIC), the Credibility and Expectancy Questionnaire, lumbar range of motion (ROM), the EuroQol-5 Dimension (EQ-5D) health survey, the Health Utility Index III (HUI-III), and economic evaluation and safety data. Post-treatment follow-ups will be conducted at 1, 4, and 10 weeks after conclusion of treatment. This study will assess the comparative effectiveness of Chuna manual therapy compared to conventional usual care. Costs and effectiveness (utility) data will be analyzed for exploratory cost-effectiveness analysis. If this pilot study does not reach a definite conclusion due to its small sample size, these results will be used as preliminary results to calculate sample size for future large-scale clinical trials and contribute in the assessment of feasibility of a full-scale multicenter trial. Clinical Research Information Service (CRIS), KCT0001850 . Registered on 17 March 2016.

Effects of structured patient education in adults with atopic dermatitis: Multicenter randomized controlled trial.

PubMed

Heratizadeh, Annice; Werfel, Thomas; Wollenberg, Andreas; Abraham, Susanne; Plank-Habibi, Sibylle; Schnopp, Christina; Sticherling, Michael; Apfelbacher, Christian; Biedermann, Tilo; Breuer, Kristine; Fell, Isabel; Fölster-Holst, Regina; Heine, Guido; Grimm, Jennifer; Hennighausen, Lars; Kugler, Claudia; Reese, Imke; Ring, Johannes; Schäkel, Knut; Schmitt, Jochen; Seikowski, Kurt; von Stebut, Esther; Wagner, Nicola; Waßmann-Otto, Anja; Wienke-Graul, Ute; Weisshaar, Elke; Worm, Margitta; Gieler, Uwe; Kupfer, Joerg

2017-09-01

Atopic dermatitis (AD) is a chronic relapsing skin disease prevalent in 1% to 3% of adults in Western industrialized countries. We sought to investigate the effectiveness of educational training in an outpatient setting on coping with the disease, quality of life, symptoms, and severity in adults with AD. In this German prospective, randomized controlled multicenter study, adult patients with moderate-to-severe AD were educated by referring to a comprehensive 12-hour training manual consented by a multiprofessional study group from different centers (Arbeitsgemeinschaft Neurodermitisschulung für Erwachsene [ARNE]). Patients were randomly allocated to the intervention or waiting control groups. Study visits were performed at baseline and after 1 year (1 year of follow-up). Primary outcomes were defined as a decrease in (1) "catastrophizing cognitions" with respect to itching (Juckreiz-Kognitions-Fragebogen questionnaire), (2) "social anxiety" (Marburger Hautfragebogen questionnaire), (3) subjective burden by symptoms of the disease (Skindex-29 questionnaire), and (4) improvement of disease signs and symptoms assessed by using the SCORAD index at 1 year of follow-up. Data were analyzed on an intention-to-treat basis. At 1 year of follow-up, patients from the intervention group (n = 168) showed a significantly better improvement compared with the waiting group (n = 147) in the following defined primary study outcomes: coping behavior with respect to itching (P < .001), quality of life assessed by using the Skindex-29 questionnaire (P < .001), and the SCORAD index (P < .001). This is the first randomized, controlled multicenter study on patient education in adult AD. The ARNE training program shows significant beneficial effects on a variety of psychosocial parameters, as well as AD severity. Copyright © 2017 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Inspection of imprint lithography patterns for semiconductor and patterned media

NASA Astrophysics Data System (ADS)

Resnick, Douglas J.; Haase, Gaddi; Singh, Lovejeet; Curran, David; Schmid, Gerard M.; Luo, Kang; Brooks, Cindy; Selinidis, Kosta; Fretwell, John; Sreenivasan, S. V.

2010-03-01

Imprint lithography has been shown to be an effective technique for replication of nano-scale features. Acceptance of imprint lithography for manufacturing will require demonstration that it can attain defect levels commensurate with the requirements of cost-effective device production. This work summarizes the results of defect inspections of semiconductor masks, wafers and hard disks patterned using Jet and Flash Imprint Lithography (J-FILTM). Inspections were performed with optical and e-beam based automated inspection tools. For the semiconductor market, a test mask was designed which included dense features (with half pitches ranging between 32 nm and 48 nm) containing an extensive array of programmed defects. For this work, both e-beam inspection and optical inspection were used to detect both random defects and the programmed defects. Analytical SEMs were then used to review the defects detected by the inspection. Defect trends over the course of many wafers were observed with another test mask using a KLA-T 2132 optical inspection tool. The primary source of defects over 2000 imprints were particle related. For the hard drive market, it is important to understand the defectivity of both the template and the imprinted disk. This work presents a methodology for automated pattern inspection and defect classification for imprint-patterned media. Candela CS20 and 6120 tools from KLA-Tencor map the optical properties of the disk surface, producing highresolution grayscale images of surface reflectivity, scattered light, phase shift, etc. Defects that have been identified in this manner are further characterized according to the morphology

2012 Mask Industry Survey

NASA Astrophysics Data System (ADS)

Malloy, Matt; Litt, Lloyd C.

2012-11-01

A survey supported by SEMATECH and administered by David Powell Consulting was sent to semiconductor industry leaders to gather information about the mask industry as an objective assessment of its overall condition. The survey was designed with the input of semiconductor company mask technologists and merchant mask suppliers. 2012 marks the 11th consecutive year for the mask industry survey. This year's survey and reporting structure are similar to those of the previous years with minor modifications based on feedback from past years and the need to collect additional data on key topics. Categories include general mask information, mask processing, data and write time, yield and yield loss, delivery times, and maintenance and returns. Within each category are multiple questions that result in a detailed profile of both the business and technical status of the mask industry. Results, initial observations, and key comparisons between the 2011 and 2012 survey responses are shown here, including multiple indications of a shift towards the manufacturing of higher end photomasks.

Is masked priming modulated by memory load? A test of the automaticity of masked identity priming in lexical decision.

PubMed

Perea, Manuel; Marcet, Ana; Lozano, Mario; Gomez, Pablo

2018-05-29

One of the key assumptions of the masked priming lexical decision task (LDT) is that primes are processed without requiring attentional resources. Here, we tested this assumption by presenting a dual-task manipulation to increase memory load and measure the change in masked identity priming on the targets in the LDT. If masked priming does not require attentional resources, increased memory load should have no influence on the magnitude of the observed identity priming effects. We conducted two LDT experiments, using a within-subjects design, to investigate the effect of memory load (via a concurrent matching task Experiment 1 and a concurrent search task in Experiment 2) on masked identity priming. Results showed that the magnitude of masked identity priming on word targets was remarkably similar under high and low memory load. Thus, these experiments provide empirical evidence for the automaticity assumption of masked identity priming in the LDT.

A Randomized Multicenter Clinical Trial of RPH With the Simplified Milligan-Morgan Hemorrhoidectomy in the Treatment of Mixed Hemorrhoids.

PubMed

He, Yong-Heng; Tang, Zhi-Jun; Xu, Xiang-Tong; Huang, De-Quan; Zhang, Li-Shun; Tang, Qing-Zhu; Fan, Zhi-Min; Zou, Xian-Jun; Zou, Guo-Jun; Zhang, Chong-Yang; Hu, Fan; Xie, Biao; Li, Yan-Hua; Tong, Yao; Liu, Hong-Chang; Li, Ke; Luo, Yu-Lian; Liu, Fei; Situ, Guang-Wei; Liu, Zuo-Long

2017-12-01

To explore the safety and efficacy of Ruiyun procedure for hemorrhoids (RPH) or RPH with the simplified Milligan-Morgan hemorrhoidectomy (sMMH) in the treatment of mixed hemorrhoids. This is a randomized, controlled, balanced, multicenter study of 3000 patients with mixed hemorrhoids. The outcomes and postoperative complications were compared between 5 types of surgeries. The efficacy rate was the highest in patients who received RPH+sMMH and decreased in the following order: patients who received RPH alone, MMH alone, procedure for prolapse and hemorrhoids (PPH) alone, and PPH+sMMH ( P < .05). The operation time was the shortest in patients who received RPH alone and increased in the following order: patients who received RPH+sMMH, PPH alone, MMH alone, and PPH+sMMH ( P < .01). The duration of postoperative hospitalization stay was the shortest in patients who received RPH alone and increased in the following order: PPH alone, RPH+sMMH, PPH+sMMH, and MMH alone ( P < .01). The incidence of postoperative hemorrhage, uroschesis, anal fissure, crissum hematoma or thrombosis, and anorectal stenosis was significantly lower in patients who received RPH+sMMH than in patients who received the other 4 types of surgical treatments ( P < .05, P < .01). No significant differences in postoperative rectovaginal fistula and anal incontinence were observed between the 5 groups of patients. RPH with or without simplified MMH can reduce the incidence of postoperative complications and improve the curative efficacy in the treatment of patients with mixed hemorrhoids.

A mask quality control tool for the OSIRIS multi-object spectrograph

NASA Astrophysics Data System (ADS)

López-Ruiz, J. C.; Vaz Cedillo, Jacinto Javier; Ederoclite, Alessandro; Bongiovanni, Ángel; González Escalera, Víctor

2012-09-01

OSIRIS multi object spectrograph uses a set of user-customised-masks, which are manufactured on-demand. The manufacturing process consists of drilling the specified slits on the mask with the required accuracy. Ensuring that slits are on the right place when observing is of vital importance. We present a tool for checking the quality of the process of manufacturing the masks which is based on analyzing the instrument images obtained with the manufactured masks on place. The tool extracts the slit information from these images, relates specifications with the extracted slit information, and finally communicates to the operator if the manufactured mask fulfills the expectations of the mask designer. The proposed tool has been built using scripting languages and using standard libraries such as opencv, pyraf and scipy. The software architecture, advantages and limits of this tool in the lifecycle of a multiobject acquisition are presented.

Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation: a randomized clinical trial.

PubMed

Indrio, Flavia; Di Mauro, Antonio; Riezzo, Giuseppe; Civardi, Elisa; Intini, Cristina; Corvaglia, Luigi; Ballardini, Elisa; Bisceglia, Massimo; Cinquetti, Mauro; Brazzoduro, Emanuela; Del Vecchio, Antonio; Tafuri, Silvio; Francavilla, Ruggiero

2014-03-01

Infantile colic, gastroesophageal reflux, and constipation are the most common functional gastrointestinal disorders that lead to referral to a pediatrician during the first 6 months of life and are often responsible for hospitalization, feeding changes, use of drugs, parental anxiety, and loss of parental working days with relevant social consequences. To investigate whether oral supplementation with Lactobacillus reuteri DSM 17938 during the first 3 months of life can reduce the onset of colic, gastroesophageal reflux, and constipation in term newborns and thereby reduce the socioeconomic impact of these conditions. A prospective, multicenter, double-masked, placebo-controlled randomized clinical trial was performed on term newborns (age <1 week) born at 9 different neonatal units in Italy between September 1, 2010, and October 30, 2012. Parents were asked to record in a structured diary the number of episodes of regurgitation, duration of inconsolable crying (minutes per day), number of evacuations per day, number of visits to pediatricians, feeding changes, hospitalizations, visits to a pediatric emergency department for a perceived health emergency, pharmacologic interventions, and loss of parental working days. In total, 589 infants were randomly allocated to receive L reuteri DSM 17938 or placebo daily for 90 days. Prophylactic use of probiotic. Reduction of daily crying time, regurgitation, and constipation during the first 3 months of life. Cost-benefit analysis of the probiotic supplementation. At 3 months of age, the mean duration of crying time (38 vs 71 minutes; P < .01), the mean number of regurgitations per day (2.9 vs 4.6; P < .01), and the mean number of evacuations per day (4.2 vs 3.6; P < .01) for the L reuteri DSM 17938 and placebo groups, respectively, were significantly different. The use of L reuteri DSM 17938 resulted in an estimated mean savings per patient of €88 (US $118.71) for the family and an additional €104 (US $140.30) for the community. Prophylactic use of L reuteri DSM 17938 during the first 3 months of life reduced the onset of functional gastrointestinal disorders and reduced private and public costs for the management of this condition. clinicaltrials.gov Identifier: NCT01235884.

The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2): study protocol for a randomized controlled trial.

PubMed

Scherer, Roberta W; Drye, Lea; Mintzer, Jacobo; Lanctôt, Krista; Rosenberg, Paul; Herrmann, Nathan; Padala, Prasad; Brawman-Mintzer, Olga; Burke, William; Craft, Suzanne; Lerner, Alan J; Levey, Allan; Porsteinsson, Anton; van Dyck, Christopher H

2018-01-18

Alzheimer's disease (AD) is characterized not only by cognitive and functional decline, but also often by the presence of neuropsychiatric symptoms. Apathy, which can be defined as a lack of motivation, is one of the most prevalent neuropsychiatric symptoms in AD and typically leads to a worse quality of life and greater burden for caregivers. Treatment options for apathy in AD are limited, but studies have examined the use of the amphetamine, methylphenidate. The Apathy in Dementia Methylphenidate Trial (ADMET) found that treatment of apathy in AD with methylphenidate was associated with significant improvement in apathy in two of three outcome measures, some evidence of improvement in global cognition, and minimal adverse events. However, the trial only enrolled 60 participants who were followed for only 6 weeks. A larger, longer-lasting trial is required to confirm these promising findings. The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2) is a phase III, placebo-controlled, masked, 6-month, multi-center, randomized clinical trial targeted to enroll 200 participants with AD and apathy. Participants are randomly assigned 1:1 to 20 mg methylphenidate per day prepared as four over-encapsulated tablets or to matching placebo. The primary outcomes include (1) the mean difference in the Neuropsychiatric Inventory Apathy subscale scores measured as change from baseline to 6 months, and (2) the odds of having a given rating or better on the modified AD Cooperative Study Clinical Global Impression of Change ratings at month 6 compared with the baseline rating. Other outcomes include change in cognition, safety, and cost-effectiveness measured at monthly follow-up visits up to 6 months. Given the prevalence of apathy in AD and its impact on both patients and caregivers, an intervention to alleviate apathy would be of great benefit to society. ADMET 2 follows on the promising results from the original ADMET to evaluate the efficacy of methylphenidate as a treatment for apathy in AD. With a larger sample size and longer follow up, ADMET 2 is poised to confirm or refute the original ADMET findings. ClinicalTrials.gov, NCT02346201 . Registered on 26 January 2015.

Brain imaging predictors and the international study to predict optimized treatment for depression: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Approximately 50% of patients with major depressive disorder (MDD) do not respond optimally to antidepressant treatments. Given this is a large proportion of the patient population, pretreatment tests that predict which patients will respond to which types of treatment could save time, money and patient burden. Brain imaging offers a means to identify treatment predictors that are grounded in the neurobiology of the treatment and the pathophysiology of MDD. Methods/Design The international Study to Predict Optimized Treatment in Depression is a multi-center, parallel model, randomized clinical trial with an embedded imaging sub-study to identify such predictors. We focus on brain circuits implicated in major depressive disorder and its treatment. In the full trial, depressed participants are randomized to receive escitalopram, sertraline or venlafaxine-XR (open-label). They are assessed using standardized multiple clinical, cognitive-emotional behavioral, electroencephalographic and genetic measures at baseline and at eight weeks post-treatment. Overall, 2,016 depressed participants (18 to 65 years old) will enter the study, of whom a target of 10% will be recruited into the brain imaging sub-study (approximately 67 participants in each treatment arm) and 67 controls. The imaging sub-study is conducted at the University of Sydney and at Stanford University. Structural studies include high-resolution three-dimensional T1-weighted, diffusion tensor and T2/Proton Density scans. Functional studies include standardized functional magnetic resonance imaging (MRI) with three cognitive tasks (auditory oddball, a continuous performance task, and Go-NoGo) and two emotion tasks (unmasked conscious and masked non-conscious emotion processing tasks). After eight weeks of treatment, the functional MRI is repeated with the above tasks. We will establish the methods in the first 30 patients. Then we will identify predictors in the first half (n = 102), test the findings in the second half, and then extend the analyses to the total sample. Trial registration International Study to Predict Optimized Treatment - in Depression (iSPOT-D). ClinicalTrials.gov, NCT00693849. PMID:23866851

Brain imaging predictors and the international study to predict optimized treatment for depression: study protocol for a randomized controlled trial.

PubMed

Grieve, Stuart M; Korgaonkar, Mayuresh S; Etkin, Amit; Harris, Anthony; Koslow, Stephen H; Wisniewski, Stephen; Schatzberg, Alan F; Nemeroff, Charles B; Gordon, Evian; Williams, Leanne M

2013-07-18

Approximately 50% of patients with major depressive disorder (MDD) do not respond optimally to antidepressant treatments. Given this is a large proportion of the patient population, pretreatment tests that predict which patients will respond to which types of treatment could save time, money and patient burden. Brain imaging offers a means to identify treatment predictors that are grounded in the neurobiology of the treatment and the pathophysiology of MDD. The international Study to Predict Optimized Treatment in Depression is a multi-center, parallel model, randomized clinical trial with an embedded imaging sub-study to identify such predictors. We focus on brain circuits implicated in major depressive disorder and its treatment. In the full trial, depressed participants are randomized to receive escitalopram, sertraline or venlafaxine-XR (open-label). They are assessed using standardized multiple clinical, cognitive-emotional behavioral, electroencephalographic and genetic measures at baseline and at eight weeks post-treatment. Overall, 2,016 depressed participants (18 to 65 years old) will enter the study, of whom a target of 10% will be recruited into the brain imaging sub-study (approximately 67 participants in each treatment arm) and 67 controls. The imaging sub-study is conducted at the University of Sydney and at Stanford University. Structural studies include high-resolution three-dimensional T1-weighted, diffusion tensor and T2/Proton Density scans. Functional studies include standardized functional magnetic resonance imaging (MRI) with three cognitive tasks (auditory oddball, a continuous performance task, and Go-NoGo) and two emotion tasks (unmasked conscious and masked non-conscious emotion processing tasks). After eight weeks of treatment, the functional MRI is repeated with the above tasks. We will establish the methods in the first 30 patients. Then we will identify predictors in the first half (n=102), test the findings in the second half, and then extend the analyses to the total sample. International Study to Predict Optimized Treatment--in Depression (iSPOT-D). ClinicalTrials.gov, NCT00693849.

Different effects of the two types of spatial pre-cueing: what precisely is "attention" in Di Lollo's and Enns' substitution masking theory?

PubMed

Luiga, I; Bachmann, T

2007-11-01

Enns and Di Lollo [Psychological Science, 8 (2), 135-139, 1997] have introduced the object substitution theory of visual masking. Object substitution masking occurs when focusing attention on the target is delayed. However, Posner (Quarterly Journal of Experimental Psychology, 32, 3-25, 1980) has already shown that attention can be directed to a target at least in two ways: intentionally (endogenously) and automatically (exogenously). We conducted two experiments to explore the effects of endogenous and exogenous cues on substitution masking. The results showed that when attention was shifted to the target location automatically (using a local peripheral pre-cue), masking was attenuated. A decrease in target identification dependent on a delay of mask offset, typical to substitution masking, was not observed. However, strong substitution masking occurred when the target location was not pre-cued or when attention was directed to the target location intentionally (using a symbolic pre-cue displayed centrally). The hypothesis of two different mechanisms of attentional control in substitution masking was confirmed.

Multiple groups of orientation-selective visual mechanisms underlying rapid orientated-line detection.

PubMed Central

Foster, D H; Westland, S

1998-01-01

Visual search for an edge or line element differing in orientation from a background of other edge or line elements can be performed rapidly and effortlessly. In this study, based on psychophysical measurements with ten human observers, threshold values of the angle between a target and background line elements were obtained as functions of background-element orientation, in brief masked displays. A repeated-loess analysis of the threshold functions suggested the existence of several groups of orientation-selective mechanisms contributing to rapid orientated-line detection; specifically, coarse, intermediate and fine mechanisms with preferred orientations spaced at angles of approximately 90 degrees, 35 degrees, and 10 degrees-25 degrees, respectively. The preferred orientations of coarse and some intermediate mechanisms coincided with the vertical or horizontal of the frontoparallel plane, but the preferred orientations of fine mechanisms varied randomly from observer to observer, possibly reflecting individual variations in neuronal sampling characteristics. PMID:9753784

Reduced OSM for Long Duration Targets: Individuation or Items Loaded into VSTM?

ERIC Educational Resources Information Center

Guest, Duncan; Gellatly, Angus; Pilling, Michael

2012-01-01

Typical studies of object substitution masking (OSM) employ a briefly presented search array. The target item is indicated by a cue/mask that surrounds but does not overlap the target and, compared to a common offset control condition, report of the target is reduced when the mask remains present after target offset. Given how little observers are…

Comparison of torsional and microburst longitudinal phacoemulsification: a prospective, randomized, masked clinical trial.

PubMed

Vasavada, Abhay R; Raj, Shetal M; Patel, Udayan; Vasavada, Vaishali; Vasavada, Viraj

2010-01-01

To compare intraoperative performance and postoperative outcome of three phacoemulsification technologies in patients undergoing microcoaxial phacoemulsification through 2.2-mm corneal incisions. The prospective, randomized, single-masked study included 360 eyes randomly assigned to torsional (Infiniti Vision System; Alcon Laboratories, Fort Worth, TX), microburst with longitudinal (Infiniti), or microburst with longitudinal (Legacy Everest, Alcon Laboratories) ultrasound. Assessments included surgical clock time, fluid volume, and intraoperative complications, central corneal thickness on day 1 and months 1 and 3 postoperatively, and endothelial cell density at 3 months postoperatively. Comparisons among groups were conducted. Torsional ultrasound required significantly less surgical clock time and fluid volume than the other groups. There were no intraoperative complications. Change in central corneal thickness and endothelial cell loss was significantly lower in the torsional ultrasound group at all postoperative visits (P < .001, Kruskal-Wallis test) compared to microburst longitudinal ultrasound modalities. Torsional ultrasound demonstrated quantitatively superior intraoperative performance and showed less increase in corneal thickness and less endothelial cell loss compared to microburst longitudinal ultrasound. Copyright 2010, SLACK Incorporated.

Estimating relative risks in multicenter studies with a small number of centers - which methods to use? A simulation study.

PubMed

Pedroza, Claudia; Truong, Van Thi Thanh

2017-11-02

Analyses of multicenter studies often need to account for center clustering to ensure valid inference. For binary outcomes, it is particularly challenging to properly adjust for center when the number of centers or total sample size is small, or when there are few events per center. Our objective was to evaluate the performance of generalized estimating equation (GEE) log-binomial and Poisson models, generalized linear mixed models (GLMMs) assuming binomial and Poisson distributions, and a Bayesian binomial GLMM to account for center effect in these scenarios. We conducted a simulation study with few centers (≤30) and 50 or fewer subjects per center, using both a randomized controlled trial and an observational study design to estimate relative risk. We compared the GEE and GLMM models with a log-binomial model without adjustment for clustering in terms of bias, root mean square error (RMSE), and coverage. For the Bayesian GLMM, we used informative neutral priors that are skeptical of large treatment effects that are almost never observed in studies of medical interventions. All frequentist methods exhibited little bias, and the RMSE was very similar across the models. The binomial GLMM had poor convergence rates, ranging from 27% to 85%, but performed well otherwise. The results show that both GEE models need to use small sample corrections for robust SEs to achieve proper coverage of 95% CIs. The Bayesian GLMM had similar convergence rates but resulted in slightly more biased estimates for the smallest sample sizes. However, it had the smallest RMSE and good coverage across all scenarios. These results were very similar for both study designs. For the analyses of multicenter studies with a binary outcome and few centers, we recommend adjustment for center with either a GEE log-binomial or Poisson model with appropriate small sample corrections or a Bayesian binomial GLMM with informative priors.

CERAMENT treatment of fracture defects (CERTiFy): protocol for a prospective, multicenter, randomized study investigating the use of CERAMENT™ BONE VOID FILLER in tibial plateau fractures

PubMed Central

2014-01-01

Background Bone graft substitutes are widely used for reconstruction of posttraumatic bone defects. However, their clinical significance in comparison to autologous bone grafting, the gold-standard in reconstruction of larger bone defects, still remains under debate. This prospective, randomized, controlled clinical study investigates the differences in pain, quality of life, and cost of care in the treatment of tibia plateau fractures-associated bone defects using either autologous bone grafting or bioresorbable hydroxyapatite/calcium sulphate cement (CERAMENT™|BONE VOID FILLER (CBVF)). Methods/Design CERTiFy (CERament™ Treatment of Fracture defects) is a prospective, multicenter, controlled, randomized trial. We plan to enroll 136 patients with fresh traumatic depression fractures of the proximal tibia (types AO 41-B2 and AO 41-B3) in 13 participating centers in Germany. Patients will be randomized to receive either autologous iliac crest bone graft or CBVF after reduction and osteosynthesis of the fracture to reconstruct the subchondral bone defect and prevent the subsidence of the articular surface. The primary outcome is the SF-12 Physical Component Summary at week 26. The co-primary endpoint is the pain level 26 weeks after surgery measured by a visual analog scale. The SF-12 Mental Component Summary after 26 weeks and costs of care will serve as key secondary endpoints. The study is designed to show non-inferiority of the CBVF treatment to the autologous iliac crest bone graft with respect to the physical component of quality of life. The pain level at 26 weeks after surgery is expected to be lower in the CERAMENT bone void filler treatment group. Discussion CERTiFy is the first randomized multicenter clinical trial designed to compare quality of life, pain, and cost of care in the use of the CBVF and the autologous iliac crest bone graft in the treatment of tibia plateau fractures. The results are expected to influence future treatment recommendations. Trial registration number ClinicalTrials.gov: NCT01828905 PMID:24606670

Effect of Armodafinil on Cortical Activity and Working Memory in Patients with Residual Excessive Sleepiness Associated with CPAP-Treated OSA: A Multicenter fMRI Study

PubMed Central

Greve, Douglas N.; Duntley, Stephen P.; Larson-Prior, Linda; Krystal, Andrew D.; Diaz, Michele T.; Drummond, Sean P. A.; Thein, Stephen G.; Kushida, Clete A.; Yang, Ronghua; Thomas, Robert J.

2014-01-01

Study Objective: To assess the effect of armodafinil on task-related prefrontal cortex activation using functional magnetic resonance imaging (fMRI) in patients with obstructive sleep apnea (OSA) and excessive sleepiness despite continuous positive airway pressure (CPAP) therapy. Methods: This 2-week, multicenter, prospective, randomized, double-blind, placebo-controlled, parallel-group study was conducted at five neuroimaging sites and four collaborating clinical study centers in the United States. Patients were 40 right-handed or ambidextrous men and women aged between 18 and 60 years, with OSA and persistent sleepiness, as determined by multiple sleep latency and Epworth Sleepiness Scale scores, despite effective, stable use of CPAP. Treatment was randomized (1:1) to once-daily armodafinil 200 mg or placebo. The primary efficacy outcome was a change from baseline at week 2 in the volume of activation meeting the predefined threshold in the dorsolateral prefrontal cortex during a 2-back working memory task. The key secondary measure was the change in task response latency. Results: No significant differences were observed between treatment groups in the primary or key secondary outcomes. Armodafinil was generally well tolerated. The most common adverse events (occurring in more than one patient [5%]) were headache (19%), nasopharyngitis (14%), and diarrhea (10%). Conclusions: Armodafinil did not improve fMRI-measured functional brain activation in CPAP-treated patients with OSA and excessive sleepiness. Study Registration: Double-Blind, Placebo-Controlled, Functional Neuroimaging Study of Armodafinil (200 mg/Day) on Prefrontal Cortical Activation in Patients With Residual Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea. ClinicalTrials.gov Identifier: NCT00711516. http://www.clinicaltrials.gov/ct2/show/study/NCT00711516 Citation: Greve DN; Duntley SP; Larson-Prior L; Krystal AD; Diaz MT; Drummond SP; Thein SG; Kushida CA; Yang R; Thomas RJ. Effect of armodafinil on cortical activity and working memory in patients with residual excessive sleepiness associated with CPAP-treated OSA: a multicenter fMRI study. J Clin Sleep Med 2014;10(2):143-153. PMID:24532997

Treatment benefit and the risk of suicidality in multicenter, randomized, controlled trials of sertraline in children and adolescents.

PubMed

March, John S; Klee, Brian J; Kremer, Charlotte M E

2006-01-01

The aim of this study was to examine the balance between the benefits of treatment and the risk of suicidality in children and adolescents in multicenter, randomized, controlled trials of sertraline versus placebo. The published literature was searched for multicenter, randomized, placebo-controlled trials of sertraline for pediatric mental disorders. Four trials were identified: Two (pooled) in pediatric major depressive disorder (MDD; Wagner 2003) and two in obsessive-compulsive disorder (OCD; March et al. 1998; POTS Team 2004). Using intent-to-treat (ITT) analysis populations, the authors calculated the number needed to treat (NNT) for response and remission and the number needed to harm (NNH) for suicidality, and their ratio, for each clinical trial. NNTs ranged from 2 to 10, indicating clinically meaningful benefits. Benefit was greater for OCD than for MDD, and for adolescents as compared with children in MDD. No age effect was apparent for OCD. Suicidality was reported in 8 patients (5 assigned to sertraline and 3 assigned to placebo). All but 1 (a placebo-treated patient in the Pfizer OCD trial) were enrolled in the sertraline MDD trial. The NNH for suicidality in MDD was 64. Treatment emergent suicidality was more common in children (NNH 28.7) than in adolescents (NNH 706.3). Because no patient developed suicidality in sertraline-treated OCD patients, the NNH for sertraline in OCD approaches infinity. With the stipulation that doctor and patient preferences necessarily play a critical role in the choice of treatment, NNT to NNH ratios indicate a positive benefit-to-risk ratio for sertraline in adolescents with MDD and in patients of all ages with OCD.

VizieR Online Data Catalog: Velocities in the A2345 cluster (Boschin+, 2010)

NASA Astrophysics Data System (ADS)

Boschin, W.; Barrena, R.; Girardi, M.

2011-08-01

Multi-object spectroscopic observations of A2345 were carried out at the TNG telescope in August 2008. We used DOLORES/MOS with the LR-B Grism 1, yielding a dispersion of 187Å/mm. We used the new E2V CCD, a matrix of 2048x2048 pixels with a pixel size of 13.5um. In total we observed four MOS masks for a total of 147 slits. Total exposure times were of 1h for three masks and 1.5h for the remaining mask. (1 data file).

High energy X-ray phase and dark-field imaging using a random absorption mask.

PubMed

Wang, Hongchang; Kashyap, Yogesh; Cai, Biao; Sawhney, Kawal

2016-07-28

High energy X-ray imaging has unique advantage over conventional X-ray imaging, since it enables higher penetration into materials with significantly reduced radiation damage. However, the absorption contrast in high energy region is considerably low due to the reduced X-ray absorption cross section for most materials. Even though the X-ray phase and dark-field imaging techniques can provide substantially increased contrast and complementary information, fabricating dedicated optics for high energies still remain a challenge. To address this issue, we present an alternative X-ray imaging approach to produce transmission, phase and scattering signals at high X-ray energies by using a random absorption mask. Importantly, in addition to the synchrotron radiation source, this approach has been demonstrated for practical imaging application with a laboratory-based microfocus X-ray source. This new imaging method could be potentially useful for studying thick samples or heavy materials for advanced research in materials science.

Optical image encryption using fresnel zone plate mask based on fast walsh hadamard transform

NASA Astrophysics Data System (ADS)

Khurana, Mehak; Singh, Hukum

2018-05-01

A new symmetric encryption technique using Fresnel Zone Plate (FZP) based on Fast Walsh Hadamard Transform (FWHT) is proposed for security enhancement. In this technique, bits of plain image is randomized by shuffling the bits randomly. The obtained scrambled image is then masked with FZP using symmetric encryption in FWHT domain to obtain final encrypted image. FWHT has been used in the cryptosystem so as to protect image data from the quantization error and for reconstructing the image perfectly. The FZP used in proposed scheme increases the key space and makes it robust to many traditional attacks. The effectiveness and robustness of the proposed cryptosystem has been analyzed on the basis of various parameters by simulating on MATLAB 8.1.0 (R2012b). The experimental results are provided to highlight suitability of the proposed cryptosystem and prove that the system is secure.

Acute pancreatitis patient registry to examine novel therapies in clinical experience (APPRENTICE): an international, multicenter consortium for the study of acute pancreatitis

PubMed Central

Papachristou, Georgios I.; Machicado, Jorge D.; Stevens, Tyler; Goenka, Mahesh Kumar; Ferreira, Miguel; Gutierrez, Silvia C.; Singh, Vikesh K.; Kamal, Ayesha; Gonzalez-Gonzalez, Jose A.; Pelaez-Luna, Mario; Gulla, Aiste; Zarnescu, Narcis O.; Triantafyllou, Konstantinos; Barbu, Sorin T.; Easler, Jeffrey; Ocampo, Carlos; Capurso, Gabriele; Archibugi, Livia; Cote, Gregory A.; Lambiase, Louis; Kochhar, Rakesh; Chua, Tiffany; Tiwari, Subhash Ch.; Nawaz, Haq; Park, Walter G.; de-Madaria, Enrique; Lee, Peter J.; Wu, Bechien U.; Greer, Phil J.; Dugum, Mohannad; Koutroumpakis, Efstratios; Akshintala, Venkata; Gougol, Amir

2017-01-01

Background We have established a multicenter international consortium to better understand the natural history of acute pancreatitis (AP) worldwide and to develop a platform for future randomized clinical trials. Methods The AP patient registry to examine novel therapies in clinical experience (APPRENTICE) was formed in July 2014. Detailed web-based questionnaires were then developed to prospectively capture information on demographics, etiology, pancreatitis history, comorbidities, risk factors, severity biomarkers, severity indices, health-care utilization, management strategies, and outcomes of AP patients. Results Between November 2015 and September 2016, a total of 20 sites (8 in the United States, 5 in Europe, 3 in South America, 2 in Mexico and 2 in India) prospectively enrolled 509 AP patients. All data were entered into the REDCap (Research Electronic Data Capture) database by participating centers and systematically reviewed by the coordinating site (University of Pittsburgh). The approaches and methodology are described in detail, along with an interim report on the demographic results. Conclusion APPRENTICE, an international collaboration of tertiary AP centers throughout the world, has demonstrated the feasibility of building a large, prospective, multicenter patient registry to study AP. Analysis of the collected data may provide a greater understanding of AP and APPRENTICE will serve as a future platform for randomized clinical trials. PMID:28042246

Transobturator TVT-O versus retropubic TVT: results of a multicenter randomized controlled trial at 24 months follow-up.

PubMed

Deffieux, Xavier; Daher, Nagib; Mansoor, Aslam; Debodinance, Philippe; Muhlstein, Joël; Fernandez, Hervé

2010-11-01

The purpose of this study is to compare the retropubic tension-free vaginal tape (TVT) procedure with the inside-out transobturator approach (TVT-O). Multicenter randomized controlled trial. One hundred forty-nine patients were randomly allocated to either TVT (n = 75) or TVT-O (n = 74). Interview, medical examination, pain scores, success rates, and quality of life assessment were recorded pre-operatively, and 2, 6, 12, and 24 months post-operatively. One hundred forty-nine patients underwent surgery, and 132 completed a 24-month follow-up. Bladder injury rate was 5% (4/75) in the TVT group and 2% (2/74) in the TVT-O group (p = 0.68). There was no significant difference between the two groups, concerning overall cure rate and the patients' satisfaction rate at 24 months follow-up. The range of mean pain scores was significantly higher after the TVT-O procedure post-operatively but not at 24 months follow-up. TVT and TVT-O procedures both have an outcome associated with an increase in quality of life with no significant differences in satisfaction rates at 2 years follow-up.

Randomized, Multicenter Study of Gefitinib Dose-escalation in Advanced Non-small-cell Lung Cancer Patients Achieved Stable Disease after One-month Gefitinib Treatment

PubMed Central

Xue, Cong; Hong, Shaodong; Li, Ning; Feng, Weineng; Jia, Jun; Peng, Jiewen; Lin, Daren; Cao, Xiaolong; Wang, Siyang; Zhang, Weimin; Zhang, Hongyu; Dong, Wei; Zhang, Li

2015-01-01

There is no consensus on the optimal treatment for patients with advanced non-small-cell lung cancer (NSCLC) and stable disease (SD) after gefitinib therapy. This randomized, open-label, multicenter study aimed to explore whether dose-escalation of gefitinib would improve response and survival in NSCLC patients who achieved SD after one-month of standard gefitinib dosage. Between May 2009 and January 2012, 466 patients were enrolled and 100 eligible patients were randomized (1:1) to receive either a higher dose (500 mg/d; H group) or to continue standard dose (250 mg/d; S group) of gefitinib. Objective response rate (ORR) was similar between the two groups (12.5% vs 12.5%, p = 1.000). There were no significant differences regarding progression-free survival (PFS) and overall survival (OS) between both arms (H group vs S group: median PFS, 5.30 months vs 6.23 months, p = 0.167; median OS, 13.70 months vs 18.87 months, p = 0.156). Therefore, dose-escalation of gefitinib does not confer a response or survival advantage in patients who achieve SD with one month of standard-dose gefitinib treatment. PMID:26216071

Postoperative therapy with infliximab for Crohn's disease: a 2-year prospective randomized multicenter study in Japan.

PubMed

Fukushima, Kouhei; Sugita, Akira; Futami, Kitaro; Takahashi, Ken-Ichi; Motoya, Satoshi; Kimura, Hideaki; Yoshikawa, Shusaku; Kinouchi, Yoshitaka; Iijima, Hideki; Endo, Katsuya; Hibi, Toshihumi; Watanabe, Mamoru; Sasaki, Iwao; Suzuki, Yasuo

2018-06-01

The prevention of postoperative recurrence is a critical issue in surgery for Crohn's disease. Prospective randomized trials in Western countries have shown that the postoperative use of anti-tumor necrosis factor α-antibodies was effective in reducing the recurrence rate. We investigated the efficacy of infliximab (IFX) for the prevention of postoperative Crohn's disease recurrence. We performed a prospective randomized multicenter study. Patients who underwent intestinal resection were assigned to groups treated with or without IFX. Immediately after surgery, patients in the IFX group received IFX at 5 mg/kg at 0, 2, and 6 weeks, followed by every 8 weeks for 2 years. The primary study outcome was the proportion of patients with endoscopic and/or clinical recurrence at 2 years after surgery. Thirty-eight eligible patients participated in this study: 19 in the IFX group and 19 in the non-IFX group. The disease recurrence rate in the IFX group was 52.6% (10/19), which was significantly lower than that in the non-IFX group (94.7% [18/19]). The postoperative use of IFX is effective in preventing Crohn's disease recurrence for 2 years.

A multi-center randomized trial of two different intravenous fluids during labor

PubMed Central

DAPUZZO-ARGIRIOU, Lisa M.; SMULIAN, John C.; ROCHON, Meredith L.; GALDI, Luisa; KISSLING, Jessika M.; SCHNATZ, Peter F.; RIOS, Angel GONZALEZ; AIROLDI, James; CARRILLO, Mary Anne; MAINES, Jaimie; KUNSELMAN, Allen R.; REPKE, John; LEGRO, Richard S.

2017-01-01

Objective To determine if the intrapartum use of a 5% glucose-containing intravenous solution decreases the chance of a cesarean delivery for women presenting in active labor. Methods This was a multi-center, prospective, single (patient) blind, randomized study design implemented at 4 obstetric residency programs in Pennsylvania. Singleton, term, consenting women presenting in active spontaneous labor with a cervical dilation of <6cm were randomized to lactated Ringer's with or without 5% glucose (LR versus D5LR) as their maintenance intravenous fluid. The primary outcome was the cesarean birth rate. Secondary outcomes included labor characteristics, as well as maternal or neonatal complications. Results There were 309 women analyzed. Demographic variables and admitting cervical dilation were similar among study groups. There was no significant difference in the cesarean delivery rate for the D5LR group (23/153 or 15.0%) versus the LR arm (18/156 or 11.5%), [RR (95%CI) of 1.32 (0.75, 2.35), P=0.34]. There were no differences in augmentation rates or intrapartum complications. Conclusions The use of intravenous fluid containing 5% dextrose does not lower the chance of cesarean delivery for women admitted in active labor. PMID:25758624

Efficacy of continuous positive airway pressure and incentive spirometry on respiratory functions during the postoperative period following supratentorial craniotomy: A prospective randomized controlled study.

PubMed

Sah, Hulya Kahraman; Akcil, Eren Fatma; Tunali, Yusuf; Vehid, Hayriye; Dilmen, Ozlem Korkmaz

2017-11-01

Volume controlled ventilation with low PEEP is used in neuro-anesthesia to provide constant PaCO 2 levels and prevent raised intracranial pressure. Therefore, neurosurgery patients prone to atelectasis formation, however, we could not find any study that evaluates prevention of postoperative pulmonary complications in neurosurgery. A prospective, randomized controlled study. Intensive care unit in a university hospital in Istanbul. Seventy-nine ASAI-II patients aged between 18 and 70years scheduled for elective supratentorial craniotomy were included in the study. Patients randomized into 3 groups after surgery. The Group IS (n=20) was treated with incentive spirometry 5 times in 1min and 5min per hour, the Group CPAP (n=20) with continuous positive airway pressure 10 cmH 2 O pressure and 0.4 F i O 2 via an oronasal mask 5min per hour, and the Group Control (n=20) 4L·min -1 O 2 via mask; all during the first 6h postoperatively. Respiratory functions tests and arterial blood gases analysis were performed before the induction of anesthesia (Baseline), 30min, 6h, 24h postoperatively. The IS and CPAP applications have similar effects with respect to FVC values. The postoperative 30min FEV 1 values were statistically significantly reduced compared to the Baseline in all groups (p<0.0001). FEV 1 values were statistically significantly increased at the postoperative 24h compared to the postoperative 30min in the Groups IS and CPAP (p<0.0001). This increase, however, was not observed in the Group Control, and the postoperative 24h FEV 1 values were statistically significantly lower in the Group Control compared to the Group IS (p=0.015). Although this study is underpowered to detect differences in FEV 1 values, the postoperative 24h FEV 1 values were significantly higher in the IS group than the Control group and this difference was not observed between the CPAP and Control groups. It might be evaluate a favorable effect of IS in neurosurgery patients. But larger studies are needed to make a certain conclusion. Copyright © 2017 Elsevier Inc. All rights reserved.

SU-E-T-65: A Prospective Trial of Open Face Masks for Head and Neck Radiotherapy

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

Wiant, D; Squire, S; Maurer, J

Purpose: Open face head and neck masks allow for active patient monitoring during treatment and may reduced claustrophobia and anxiety compared to closed masks. The ability of open masks to limit intrafraction motion and to preserve the patient shape/position from simulation over protracted treatments should be considered. Methods: Thirty-two head and neck patients were prospectively randomized to treatment in a closed mask or a novel open face mask. All patients received daily volumetric imaging. The daily images were automatically rigidly registered to the planning CT’s offline using a commercial image processing tool. The shifts needed to optimize the registration, themore » mutual information coefficient (MI), and the Pearson correlation (PC) coefficients were recorded to evaluate shape preservation. The open group was set-up and monitored with surface imaging at treatment. The real time surface imaging information was recorded to evaluate intrafraction motion. Results: Sixteen patients were included in each group. Evaluations were made over a total of 984 fractions. The mean MI and PC showed significantly higher shape preservation for the open group than for the closed group (p = 0). The mean rotations for the open group were smaller or < 0.15° larger versus the closed group. The mean intrafraction motion for the open group was 0.93 +/−0.99 mm (2 SD). The maximum single fraction displacement was 3.2 mm. Fourteen of 16 patients showed no significant correlation of motion with fraction number (p > 0.05). Conclusion: The open masks preserved shape as well as the closed masks, and they limited motion to < 2 mm for 95% of the treated fractions. These results are consistent over treatment courses of up to 35 fractions. The open mask is suitable for treatment with or without active monitoring. This work was partially supported by Qfix.« less

Long-term Outcomes of Laparoscopic Versus Open Surgery for Clinical Stage II/III Gastric Cancer: A Multicenter Cohort Study in Japan (LOC-A Study).

PubMed

Kinoshita, Takahiro; Uyama, Ichiro; Terashima, Masanori; Noshiro, Hirokazu; Nagai, Eishi; Obama, Kazutaka; Tamamori, Yutaka; Nabae, Toshinaga; Honda, Michitaka; Abe, Takayuki

2018-04-24

A large-scale multicenter historical cohort study was conducted to investigate the efficacy of laparoscopic gastrectomy (LG) in comparison to open gastrectomy (OG) for locally advanced gastric cancer. LG is now practiced widely, but its applicability for advanced gastric cancer is still controversial. As oncologic outcomes of randomized trials are still pending, there is an urgent need for information that would be relevant to current practice. Through a consensus meeting involving surgeons and biostatisticians, 30 preoperative variables possibly influencing the choice of surgical approach and associated with outcome were identified to enable rigorous estimation of propensity scores. A total of 1948 consecutive patients who underwent gastrectomy for clinical stage II/III gastric adenocarcinoma between 2008 and 2014 were identified, and their clinical data were collected from 8 participating hospitals. After propensity score matching, 610 cases (OG = 305, LG = 305) were finally selected for comparison of long-term outcomes. In the propensity-matched OG and LG populations, the mean observation period was 3.5 and 3.4 years, and the 5-year overall survival was 53.0% and 54.2%, respectively. The hazard ratio (LG/OG) for overall survival was 1.01 (95% confidence interval, 0.80-1.29), and noninferiority of LG was demonstrated statistically as the upper 95% confidence limit was less than the prespecified margin (1.33). The recurrence rate was 30.8% and 29.8% for OG and LG, respectively, and the hazard ratio for recurrence was 0.98 (95% confidence interval, 0.74-1.31). The patterns of recurrence in the 2 groups were similar. This observational study strictly adjusted for confounding factors has provided evidence to suggest that LG is oncologically comparable to OG for locally advanced gastric cancer. The validity of this result will be examined in ongoing randomized trials.

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

PubMed

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

2018-04-01

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

Factors responsible for remote-frequency masking in children and adultsa)

PubMed Central

Leibold, Lori J.; Buss, Emily

2016-01-01

Susceptibility to remote-frequency masking in children and adults was evaluated with respect to three stimulus features: (1) masker bandwidth, (2) spectral separation of the signal and masker, and (3) gated versus continuous masker presentation. Listeners were 4- to 6-year-olds, 7- to 10-year-olds, and adults. Detection thresholds for a 500-ms, 2000-Hz signal were estimated in quiet or presented with a band of noise in one of four frequency regions: 425–500 Hz, 4000–4075 Hz, 8000–8075 Hz, or 4000–10 000 Hz. In experiment 1, maskers were gated on in each 500-ms interval of a three-interval, forced-choice adaptive procedure. Masking was observed for all ages in all maskers, but the greatest masking was observed for the 4000–4075 Hz masker. These findings suggest that signal/masker spectral proximity plays an important role in remote-frequency masking, even when peripheral excitation associated with the signal and masker does not overlap. Younger children tended to have more masking than older children or adults, consistent with a reduced ability to segregate simultaneous sounds and/or listen in a frequency-selective manner. In experiment 2, detection thresholds were estimated in the same noises, but maskers were presented continuously. Masking was reduced for all ages relative to gated conditions, suggesting improved segregation and/or frequency-selective listening. PMID:28040030

Vision-Related Quality-of-Life Outcomes in the Mycotic Ulcer Treatment Trial I

PubMed Central

Rose-Nussbaumer, Jennifer; Prajna, N. Venkatesh; Krishnan, K. Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E.; O’Brien, Kieran S.; Ray, Kathryn J.; McLeod, Stephen D.; Porco, Travis C.; Lietman, Thomas M.; Acharya, Nisha R.; Keenan, Jeremy D.

2016-01-01

IMPORTANCE Given the limitations in health care resources, quality-of-life measures for interventions have gained importance. OBJECTIVE To determine whether vision-related quality-of-life outcomes were different between the natamycin and voriconazole treatment arms in the Mycotic Ulcer Treatment Trial I, as measured by an Indian Vision Function Questionnaire. DESIGN, SETTING, AND PARTICIPANTS Secondary analysis (performed October 11–25, 2014) of a double-masked, multicenter, randomized, active comparator–controlled, clinical trial at multiple locations of the Aravind Eye Care System in South India that enrolled patients with culture- or smear-positive filamentous fungal corneal ulcers who had a baseline visual acuity of 20/40 to 20/400 (logMAR of 0.3–1.3). INTERVENTIONS Study participants were randomly assigned to topical voriconazole, 1%, or topical natamycin, 5%. MAIN OUTCOMES AND MEASURES Subscale score on the Indian Vision Function Questionnaire from each of the 4 subscales (mobility, activity limitation, psychosocial impact, and visual function) at 3 months. RESULTS A total of 323 patients were enrolled in the trial, and 292 (90.4%) completed the Indian Vision Function Questionnaire at 3 months. The majority of study participants had subscale scores consistent with excellent function. After adjusting for baseline visual acuity and organism, we found that study participants in the natamycin-treated group scored, on average, 4.3 points (95% CI, 0.1–8.5) higher than study participants in the voriconazole-treated group (P = .046). In subgroup analyses looking at ulcers caused by Fusarium species and adjusting for baseline best spectacle–corrected visual acuity, the natamycin-treated group scored 8.4 points (95% CI, 1.9–14.9) higher than the voriconazole-treated group (P = .01). Differences in quality of life were not detected for patients with Aspergillus or other non-Fusarium species as the causative organism (1.5 points [95% CI, −3.9 to 6.9]; P = .52). CONCLUSIONS AND RELEVANCE We found evidence of improvement in vision-related quality of life among patients with fungal ulcers who were randomly assigned to natamycin compared with those randomly assigned to voriconazole, and especially among patients with Fusarium species as the causative organism. Incorporation of quality-of-life measures in clinical trials is important to fully evaluate the effect of the studied interventions. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00996736 PMID:25764482

The Effect Of Digital Unsharp Masking On The Detectability Of Interstitial Infiltrates And Pneumothoraces

NASA Astrophysics Data System (ADS)

MacMahon, Heber; Vyborny, Carl; Sabeti, Victoria; Metz, Charles; Doi, Kunio

1985-09-01

A potential advantage of digital radiographic systems is their ability to enhance images by various types of processing. Digital unsharp masking is one of the simplest and potentially most useful forms of enhancement. The efficacy of unsharp masking in clinical radiologic diagnosis has not been investigated systematically, however. The effect of digital unsharp masking on the detectability of two types of subtle abnormalities, pneumothorax and interstitial infiltrate, was studied in an observer performance test. An ROC analysis of this preliminary data suggests that unsharp masking may improve diagnostic accuracy for pneumothorax. Radiologists' performance in identifying interstitial infiltrates was degraded by the image processing, however, and false positive diagnoses tended to be more frequent.

Effect of structured physical activity on respiratory outcomes in sedentary elderly adults with mobility limitations

USDA-ARS?s Scientific Manuscript database

OBJECTIVES: To evaluate the effect of structured physical activity on respiratory outcomes in community dwelling elderly adults with mobility limitations. DESIGN: Multicenter, randomized trial of physical activity vs health education, with respiratory variables prespecified as tertiary outcomes over...

Lifestyle interventions and independence for elders study: Recruitment and baseline characteristics

USDA-ARS?s Scientific Manuscript database

Recruitment of older adults into long-term clinical trials involving behavioral interventions is a significant challenge. The Lifestyle Interventions and Independence for Elders (LIFE) Study is a Phase 3 multicenter randomized controlled multisite trial, designed to compare the effects of a moderate...

Randomized double-blind placebo-controlled multicenter evaluation of efficacy and dose finding of midodrine hydrochloride in women with mild to moderate stress urinary incontinence: a phase II study.

PubMed

Weil, E H; Eerdmans, P H; Dijkman, G A; Tamussino, K; Feyereisl, J; Vierhout, M E; Schmidbauer, C; Egarter, C; Kölle, D; Plasman, J E; Heidler, H; Abbühl, B E; Wein, W

1998-01-01

Midodrine is a potent and selective alpha1-receptor agonist and its potential to increase urethral closure pressure could be useful in the treatment of female stress incontinence. The aim of this randomized double-blind placebo-controlled multicenter study was to evaluate the efficacy and safety of midodrine for the treatment of stress urinary incontinence. The primary criterion of efficacy was the maximum urethral closure pressure at rest. Voiding diaries, symptom and incontinence questionnaires and patient/investigator global assessment were also used to evaluate its efficacy. After 4 weeks of treatment no significant changes in MUCP were found. The global assessment by the patient and investigator did indicate that patients on active treatment had a more positive assessment than the placebo group. In conclusion, midodrine did not cause significant improvements in urodynamic parameters, but there were subjective improvements in some of the patients in the treated groups. Furthermore midodrine was well tolerated.

A comparative multicenter study of two transdermal estradiol replacement therapies in the treatment of postmenopausal symptoms.

PubMed

Van Leusden, H A; Albertyn, G; Verlaine, C; Van Ruymbeke, J

1993-01-01

Comparison of the effects of treatment of two transdermal therapeutic systems for estrogen replacement therapy with regard to efficacy, tolerability, and acceptance. Open randomized. Multicenter. A study population of 104 postmenopausal women was randomized on a 1:1 basis to treatment with one of two estradiol patches, System (Cilag) and Estraderm (Ciba-Geigy). Systolic and diastolic BP, hot flushes, night sweating, fatigue, insomnia, depression, nervousness, headache, vaginal discomfort (efficacy variables); bleeding, dermatological symptoms, comfort and adhesiveness of patch, and other possible causes of discontinuation (tolerability); general evaluation by patient (acceptance). Considering all efficacy variables, 53% of Systen and 46% of Estraderm patients found the therapy satisfactory. Tolerability was somewhat higher in the Systen group. Adhesiveness of the patch was significantly better for Systen. Overall, 79% of Systen patients and 62% of Estraderm patients evaluated treatment as "good" or "very good." The majority of patients in both groups found the patch very comfortable or only slightly obtrusive.

Platelet-Derived Growth Factor Promotes Periodontal Regeneration in Localized Osseous Defects: 36-Month Extension Results From a Randomized, Controlled, Double-Masked Clinical Trial

PubMed Central

Nevins, Myron; Kao, Richard T.; McGuire, Michael K.; McClain, Pamela K.; Hinrichs, James E.; McAllister, Bradley S.; Reddy, Michael S.; Nevins, Marc L.; Genco, Robert J.; Lynch, Samuel E.; Giannobile, William V.

2017-01-01

Background Recombinant human platelet-derived growth factor (rhPDGF) is safe and effective for the treatment of periodontal defects in short-term studies up to 6 months in duration. We now provide results from a 36-month extension study of a multicenter, randomized, controlled clinical trial evaluating the effect and long-term stability of PDGF-BB treatment in patients with localized severe periodontal osseous defects. Methods A total of 135 participants were enrolled fromsix clinical centers for an extension trial. Eighty-three individuals completed the study at 36 months and were included in the analysis. The study investigated the local application of β-tricalcium phosphate scaffold matrix with or without two different dose levels of PDGF (0.3 or 1.0 mg/mL PDGF-BB) in patients possessing one localized periodontal osseous defect. Composite analysis for clinical and radiographic evidence of treatment success was defined as percentage of cases with clinical attachment level (CAL) ≥2.7mmand linear bone growth (LBG) ≥1.1 mm. Results The participants exceeding this composite outcome benchmark in the 0.3 mg/mL rhPDGF-BB group went from 62.2% at 12 months, 75.9% at 24 months, to 87.0% at 36 months compared with 39.5%, 48.3%, and 53.8%, respectively, in the scaffold control group at these same time points (P <0.05). Although there were no significant increases in CAL and LBG at 36 months among all groups, there were continued increases in CAL gain, LBG, and percentage bone fill over time, suggesting overall stability of the regenerative response. Conclusion PDGF-BB in a synthetic scaffold matrix promotes long-term stable clinical and radiographic improvements as measured by composite outcomes for CAL gain and LBG for patients possessing localized periodontal defects (ClinicalTrials.gov no. CT01530126). PMID:22612364

Teprotumumab for Thyroid-Associated Ophthalmopathy

PubMed Central

Smith, Terry J.; Kahaly, George J.; Ezra, Daniel G.; Fleming, James C.; Dailey, Roger A.; Tang, Rosa A.; Harris, Gerald J.; Antonelli, Alessandro; Salvi, Mario; Goldberg, Robert A.; Gigantelli, James W.; Couch, Steven M.; Shriver, Erin M.; Hayek, Brent R.; Hink, Eric M.; Woodward, Richard M.; Gabriel, Kathleen; Magni, Guido; Douglas, Raymond S.

2017-01-01

BACKGROUND Thyroid-associated ophthalmopathy, a condition commonly associated with Graves’ disease, remains inadequately treated. Current medical therapies, which primarily consist of glucocorticoids, have limited efficacy and present safety concerns. Inhibition of the insulin-like growth factor I receptor (IGF-IR) is a new therapeutic strategy to attenuate the underlying autoimmune pathogenesis of ophthalmopathy. METHODS We conducted a multicenter, double-masked, randomized, placebo-controlled trial to determine the efficacy and safety of teprotumumab, a human monoclonal antibody inhibitor of IGF-IR, in patients with active, moderate-to-severe ophthalmopathy. A total of 88 patients were randomly assigned to receive placebo or active drug administered intravenously once every 3 weeks for a total of eight infusions. The primary end point was the response in the study eye. This response was defined as a reduction of 2 points or more in the Clinical Activity Score (scores range from 0 to 7, with a score of ≥3 indicating active thyroid-associated ophthalmopathy) and a reduction of 2 mm or more in proptosis at week 24. Secondary end points, measured as continuous variables, included proptosis, the Clinical Activity Score, and results on the Graves’ ophthalmopathy–specific quality-of-life questionnaire. Adverse events were assessed. RESULTS In the intention-to-treat population, 29 of 42 patients who received teprotumumab (69%), as compared with 9 of 45 patients who received placebo (20%), had a response at week 24 (P<0.001). Therapeutic effects were rapid; at week 6, a total of 18 of 42 patients in the teprotumumab group (43%) and 2 of 45 patients in the placebo group (4%) had a response (P<0.001). Differences between the groups increased at subsequent time points. The only drug-related adverse event was hyperglycemia in patients with diabetes; this event was controlled by adjusting medication for diabetes. CONCLUSIONS In patients with active ophthalmopathy, teprotumumab was more effective than placebo in reducing proptosis and the Clinical Activity Score. (Funded by River Vision Development and others; ClinicalTrials.gov number, NCT01868997.) PMID:28467880

Polyquaternium-1-Preserved Travoprost 0.003% or Benzalkonium Chloride-Preserved Travoprost 0.004% for Glaucoma and Ocular Hypertension.

PubMed

Peace, James H; Ahlberg, Peter; Wagner, Mathias; Lim, John M; Wirta, David; Branch, James D

2015-08-01

To demonstrate equivalence of polyquaternium-1-preserved travoprost 0.003% with benzalkonium chloride-preserved travoprost 0.004% in patients with open-angle glaucoma or ocular hypertension. Double-masked, randomized, 2-treatment, equivalence clinical trial. setting: Multicenter clinical trial conducted in 60 centers in the United States and Europe. Adult patients with open-angle glaucoma or ocular hypertension. One eye per patient was analyzed. Patients were randomized 1:1 to receive polyquaternium-1-preserved travoprost 0.003% (n = 442) or benzalkonium chloride-preserved travoprost 0.004% (n = 422) once daily for 3 months. Mean intraocular pressure (IOP) was assessed at 8 AM, 10 AM, and 4 PM at week 2, week 6, and month 3. Supportive outcomes were mean and percent IOP change, percentage of patients achieving IOP <18 mm Hg or ≥30% IOP reduction, and adverse events. Mean IOP was similar between groups at all study visits (travoprost 0.003% range, 17.5-18.9 mm Hg; travoprost 0.004% range, 17.4-19.0 mm Hg). Mean change (least squares mean differences, -0.1 to 0.3 mm Hg; 95% confidence interval, -0.5 to 0.7 mm Hg) and percentage change (travoprost 0.003%, 28.4%-30.7%; travoprost 0.004%, 28.5%-31.0%) from baseline were comparable. The percentages of patients with IOP <18 mm Hg and ≥30% reduction of IOP were also similar. Hyperemia was the most frequent treatment-related adverse event with both formulations (travoprost 0.003%, 11.8%; travoprost 0.004%, 14.5%). In patients with open-angle glaucoma or ocular hypertension, polyquaternium-1-preserved travoprost 0.003% solution provided equivalent IOP-lowering efficacy to that of benzalkonium chloride-preserved travoprost 0.004%. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Effects of vitamin D supplementation on insulin resistance and cardiometabolic risk factors in children with metabolic syndrome: a triple-masked controlled trial.

PubMed

Kelishadi, Roya; Salek, Shadi; Salek, Mehdi; Hashemipour, Mahin; Movahedian, Mahsa

2014-01-01

This triple-masked controlled trial aimed to assess the effects of vitamin D supplementation on insulin resistance and cardiometabolic risk factors in obese children and adolescents. The study comprised 50 participants, aged 10 to 16 years, who were randomly assigned into two groups of equal number. In this 12-week trial, one group received oral vitamin D (300,000 IU) and the other group received placebo. Cardiometabolic risk factors, insulin resistance, and a continuous value of metabolic syndrome (cMetS) were determined. Statistical analysis was conducted after adjustment for covariate interactions. Overall, 21 patients in the vitamin D group and 22 in the placebo group completed the trial. No significant difference was observed in the baseline characteristics of the two groups. After the trial, in the vitamin D group, serum insulin and triglyceride concentrations, as well as HOM -IR and C-MetS decreased significantly, both when compared with the baseline and with the placebo group. No significant difference was observed when comparing total cholesterol, LDL-C, HDL-C, fasting blood glucose, and blood pressure. The present findings support the favorable effects of vitamin D supplementation on reducing insulin resistance and cardiometabolic risk factors in obese children. Copyright © 2013 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.

Comparison of postoperative complication between Laryngeal Mask Airway and endotracheal tube during low-flow anesthesia with controlled ventilation

PubMed Central

Peirovifar, Ali; Eydi, Mahmood; Mirinejhad, Mir Mousa; Mahmoodpoor, Ata; Mohammadi, Afsaneh; EJ Golzari, Samad

2013-01-01

Objective: To compare the postoperative complications between Laryngeal Mask Airway (LMA) and endotracheal tube (ETT) during low-flow anesthesia with controlled ventilation. Methodology: Eighty adult Patients with ASA class I or II were randomly allocated into two forty-patient groups (ETT or LMA). Cuff pressure was monitored during anesthesia. After high uptake period, fresh gas flow (FGF) was decreased to 1 lit/min and isoflurane set to 1%. Monitoring during anesthesia included non-invasive blood pressure, ECG, ETCO2 and pulse oximetry. System leakage (>100 ml/min), rebreathing and any attempt to increase FGF to overcome the leak were monitored during anesthesia. Later, patients were extubated and transferred to Post Anesthesia Care Unit (PACU). In PACU, the incidence of sore throat, cough, difficulty in swallowing and shivering was monitored for all patients. Results: Leakage was observed in two and three cases in ETT and LMA groups respectively (P>0.05). Postoperative cough, sore throat and difficulty in swallowing were significantly less in LMA than ETT group. No significant difference was observed regarding ETCo2 values between 2 groups. Conclusion: If careful measures regarding insertion techniques, correct LMA position and routine monitoring of LMA cuff pressure are taken, LMA can be used as a safe alternative with lower incidence of post operation complication compared with ETT during low-flow controlled anesthesia with modern anesthetic machines. PMID:24353586

Emergency face-mask removal effectiveness: a comparison of traditional and nontraditional football helmet face-mask attachment systems.

PubMed

Swartz, Erik E; Belmore, Keith; Decoster, Laura C; Armstrong, Charles W

2010-01-01

Football helmet face-mask attachment design changes might affect the effectiveness of face-mask removal. To compare the efficiency of face-mask removal between newly designed and traditional football helmets. Controlled laboratory study. Applied biomechanics laboratory. Twenty-five certified athletic trainers. The independent variable was face-mask attachment system on 5 levels: (1) Revolution IQ with Quick Release (QR), (2) Revolution IQ with Quick Release hardware altered (QRAlt), (3) traditional (Trad), (4) traditional with hardware altered (TradAlt), and (5) ION 4D (ION). Participants removed face masks using a cordless screwdriver with a back-up cutting tool or only the cutting tool for the ION. Investigators altered face-mask hardware to unexpectedly challenge participants during removal for traditional and Revolution IQ helmets. Participants completed each condition twice in random order and were blinded to hardware alteration. Removal success, removal time, helmet motion, and rating of perceived exertion (RPE). Time and 3-dimensional helmet motion were recorded. If the face mask remained attached at 3 minutes, the trial was categorized as unsuccessful. Participants rated each trial for level of difficulty (RPE). We used repeated-measures analyses of variance (α  =  .05) with follow-up comparisons to test for differences. Removal success was 100% (48 of 48) for QR, Trad, and ION; 97.9% (47 of 48) for TradAlt; and 72.9% (35 of 48) for QRAlt. Differences in time for face-mask removal were detected (F(4,20)  =  48.87, P  =  .001), with times ranging from 33.96 ± 14.14 seconds for QR to 99.22 ± 20.53 seconds for QRAlt. Differences were found in range of motion during face-mask removal (F(4,20)  =  16.25, P  =  .001), with range of motion from 10.10° ± 3.07° for QR to 16.91° ± 5.36° for TradAlt. Differences also were detected in RPE during face-mask removal (F(4,20)  =  43.20, P  =  .001), with participants reporting average perceived difficulty ranging from 1.44 ± 1.19 for QR to 3.68 ± 1.70 for TradAlt. The QR and Trad trials resulted in superior results. When trials required cutting loop straps, results deteriorated.

A randomized, multicenter phase 3 study comparing 2% rebamipide (OPC-12759) with 0.1% sodium hyaluronate in the treatment of dry eye.

PubMed

Kinoshita, Shigeru; Oshiden, Kazuhide; Awamura, Saki; Suzuki, Hiroyuki; Nakamichi, Norihiro; Yokoi, Norihiko

2013-06-01

To investigate the efficacy of 2% rebamipide ophthalmic suspension compared with 0.1% sodium hyaluronate ophthalmic solution for the treatment of patients with dry eye. Randomized, multicenter, active-controlled parallel-group study. One hundred eighty-eight patients with dry eye. Following a 2-week screening period, patients were allocated randomly to receive 2% rebamipide or 0.1% sodium hyaluronate, administered as 1 drop in each eye 4 or 6 times daily, respectively, for 4 weeks. There were 2 primary end points: changes in the fluorescein corneal staining (FCS) score to determine noninferiority of 2% rebamipide and changes in the lissamine green conjunctival staining (LGCS) score to determine superiority. Secondary objective end points were Schirmer's test results and tear film breakup time (TBUT). Secondary subjective end points were dry eye-related ocular symptoms (foreign body sensation, dryness, photophobia, eye pain, and blurred vision) score and the patients' overall treatment impression score. In the primary analysis, the mean change from baseline in FCS scores verified noninferiority, indicated significant improvement, and, in LGCS scores, verified the superiority of 2% rebamipide to 0.1% sodium hyaluronate. Values for the Schirmer's test and TBUT were comparable between the 2 groups. For 2 dry eye-related ocular symptoms--foreign body sensation and eye pain--2% rebamipide showed significant improvements over 0.1% sodium hyaluronate. Patients had a significantly more favorable impression of 2% rebamipide than of 0.1% sodium hyaluronate; 64.5% rated treatment as improved or markedly improved versus 34.7%, respectively. No serious adverse events were observed. Administration of 2% rebamipide was effective in improving both the objective signs and subjective symptoms of dry eye. Those findings, in addition to the well-tolerated profile of 2% rebamipide, clearly show that it is an effective therapeutic method for dry eye. Proprietary or commercial disclosure may be found after the references. Copyright © 2013 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Serenoa repens, lycopene and selenium versus tamsulosin for the treatment of LUTS/BPH. An Italian multicenter double-blinded randomized study between single or combination therapy (PROCOMB trial).

PubMed

Morgia, Giuseppe; Russo, Giorgio I; Voce, Salvatore; Palmieri, Fabiano; Gentile, Marcello; Giannantoni, Antonella; Blefari, Franco; Carini, Marco; Minervini, Andrea; Ginepri, Andrea; Salvia, Giuseppe; Vespasiani, Giuseppe; Santelli, Giorgio; Cimino, Sebastiano; Allegro, Rosalinda; Collura, Zaira; Fragalà, Eugenia; Arnone, Salvatore; Pareo, Rosaria M

2014-11-01

Phytotherapy has been used to treat patients with lower urinary tract symptoms (LUTS). We evaluated the efficacy and tolerability of combination therapy between Serenoa Repens (SeR), Lycopene (Ly), and Selenium (Se) + tamsulosin versus single therapies. PROCOMB trial (ISRCTN78639965) was a randomized double-blinded, double-dummy multicenter study of 225 patients between 55 and 80 years old, PSA ≤ 4 ng/ml, IPSS ≥12, prostate volume ≤60 cc, Qmax ≤15 ml/sec, postvoid residual urine (PVR) <150 ml. Participants were randomized group A (SeR-Se-Ly), group B (tamsulosin 0.4 mg), group C (SeR-Se-Ly + tamsulosin 0.4 mg). The primary endpoints of the study were the reduction of IPSS, PVR, and increase of Qmax in group C versus monotherapy groups. The decrease for combination therapy was significantly greater versus group A (P < 0.05) and group B (P < 0.01) for IPSS and versus group A (P < 0.01) for PVR from baseline to 6 months. A greater decrease in IPSS was observed for Group C versus group A (P < 0.01) and increase in Qmax versus group B (P < 0.01), from 6 months to 12 months. At one year, the changes of IPSS and Qmax were greater for Group C versus monotherapies (each comparison <0.05). The proportions of men with a decrease of at least three points (each comparison P < 0.05) and decrease of 25% for IPSS (each comparison P < 0.01) were greater for Group C. SeR-Se-Ly + tamsulosin therapy is more effective than single therapies in improving IPSS and increasing Qmax in patients with LUTS. © 2014 Wiley Periodicals, Inc.

Knowledge and attitudes of nurses on pressure ulcer prevention: a cross-sectional multicenter study in Belgian hospitals.

PubMed

Beeckman, Dimitri; Defloor, Tom; Schoonhoven, Lisette; Vanderwee, Katrien

2011-09-01

Evidence-based guidelines for pressure ulcer prevention have been developed and promoted by authoritative organizations. However, nonadherence to these guidelines is frequently reported. Negative attitudes and lack of knowledge may act as barriers to using guidelines in clinical practice. To study the knowledge and attitudes of nurses about pressure ulcer prevention in Belgian hospitals and to explore the correlation between knowledge, attitudes, and the application of adequate prevention. A cross-sectional multicenter study was performed in a random sample of 14 Belgian hospitals, representing 207 wards. Out of that group, 94 wards were randomly selected (2105 patients). Clinical observations were performed to assess the adequacy of pressure ulcer prevention and pressure ulcer prevalence. From each participating ward, a random selection of at least five nurses completed an extensively validated knowledge and attitude instrument. In total, 553 nurses participated. A logistic regression analysis was performed to evaluate the correlation between knowledge, attitudes, and the application of adequate prevention. Pressure ulcer prevalence (Category I-IV) was 13.5% (284/2105). Approximately 30% (625/2105) of the patients were at risk (Bradenscore <17 and/or presence of pressure ulcer). Only 13.9% (87/625) of these patients received fully adequate prevention whilst in bed and when seated. The mean knowledge and attitude scores were 49.7% and 71.3%, respectively. The application of adequate prevention on a nursing ward was significantly correlated with the attitudes of the nurses (OR = 3.07, p = .05). No independent correlation was found between knowledge and the application of adequate prevention (OR = 0.75, p = .71). Knowledge of nurses in Belgian hospitals about the prevention of pressure ulcers is inadequate. The attitudes of nurses toward pressure ulcers are significantly correlated with the application of adequate prevention. No correlation was found between knowledge and the application of adequate prevention. Copyright ©2011 Sigma Theta Tau International.

CONKO-005: Adjuvant Chemotherapy With Gemcitabine Plus Erlotinib Versus Gemcitabine Alone in Patients After R0 Resection of Pancreatic Cancer: A Multicenter Randomized Phase III Trial.

PubMed

Sinn, Marianne; Bahra, Marcus; Liersch, Torsten; Gellert, Klaus; Messmann, Helmut; Bechstein, Wolf; Waldschmidt, Dirk; Jacobasch, Lutz; Wilhelm, Martin; Rau, Bettina M; Grützmann, Robert; Weinmann, Arndt; Maschmeyer, Georg; Pelzer, Uwe; Stieler, Jens M; Striefler, Jana K; Ghadimi, Michael; Bischoff, Sven; Dörken, Bernd; Oettle, Helmut; Riess, Hanno

2017-10-10

Purpose Gemcitabine is standard of care in the adjuvant treatment of resectable pancreatic ductal adenocarcinoma (PDAC). The epidermal growth factor receptor tyrosine kinase inhibitor erlotinib in combination with gemcitabine has shown efficacy in the treatment of advanced PDAC and was considered to improve survival in patients with primarily resectable PDAC after R0 resection. Patients and Methods In an open-label, multicenter trial, patients were randomly assigned to one of two study arms: gemcitabine 1,000 mg/m 2 days 1, 8, 15, every 4 weeks plus erlotinib 100 mg once per day (GemErlo) or gemcitabine (Gem) alone for six cycles. The primary end point of the study was to improve disease-free survival (DFS) from 14 to 18 months by adding erlotinib to gemcitabine. Results In all, 436 patients were randomly assigned at 57 study centers between April 2008 and July 2013. A total of 361 instances (83%) of disease recurrence were observed after a median follow-up of 54 months. Median treatment duration was 22 weeks in both arms. There was no difference in median DFS (GemErlo 11.4 months; Gem 11.4 months) or median overall survival (GemErlo 24.5 months; Gem 26.5 months). There was a trend toward long-term survival in favor of GemErlo (estimated survival after 1, 2, and 5 years for GemErlo was 77%, 53%, and 25% v 79%, 54%, and 20% for Gem, respectively). The occurrence or the grade of rash was not associated with a better survival in the GemErlo arm. Conclusion To the best of our knowledge, CONKO-005 is the first study to investigate the combination of chemotherapy and a targeted therapy in the adjuvant treatment of PDAC. GemErlo for 24 weeks did not improve DFS or overall survival over Gem.

Efficacy and Safety of Trabectedin or Dacarbazine for Metastatic Liposarcoma or Leiomyosarcoma After Failure of Conventional Chemotherapy: Results of a Phase III Randomized Multicenter Clinical Trial.

PubMed

Demetri, George D; von Mehren, Margaret; Jones, Robin L; Hensley, Martee L; Schuetze, Scott M; Staddon, Arthur; Milhem, Mohammed; Elias, Anthony; Ganjoo, Kristen; Tawbi, Hussein; Van Tine, Brian A; Spira, Alexander; Dean, Andrew; Khokhar, Nushmia Z; Park, Youn Choi; Knoblauch, Roland E; Parekh, Trilok V; Maki, Robert G; Patel, Shreyaskumar R

2016-03-10

This multicenter study, to our knowledge, is the first phase III trial to compare trabectedin versus dacarbazine in patients with advanced liposarcoma or leiomyosarcoma after prior therapy with an anthracycline and at least one additional systemic regimen. Patients were randomly assigned in a 2:1 ratio to receive trabectedin or dacarbazine intravenously every 3 weeks. The primary end point was overall survival (OS), secondary end points were disease control-progression-free survival (PFS), time to progression, objective response rate, and duration of response-as well as safety and patient-reported symptom scoring. A total of 518 patients were enrolled and randomly assigned to either trabectedin (n = 345) or dacarbazine (n = 173). In the final analysis of PFS, trabectedin administration resulted in a 45% reduction in the risk of disease progression or death compared with dacarbazine (median PFS for trabectedin v dacarbazine, 4.2 v 1.5 months; hazard ratio, 0.55; P < .001); benefits were observed across all preplanned subgroup analyses. The interim analysis of OS (64% censored) demonstrated a 13% reduction in risk of death in the trabectedin arm compared with dacarbazine (median OS for trabectedin v dacarbazine, 12.4 v 12.9 months; hazard ratio, 0.87; P = .37). The safety profiles were consistent with the well-characterized toxicities of both agents, and the most common grade 3 to 4 adverse effects were myelosuppression and transient elevation of transaminases in the trabectedin arm. Trabectedin demonstrates superior disease control versus conventional dacarbazine in patients who have advanced liposarcoma and leiomyosarcoma after they experience failure of prior chemotherapy. Because disease control in advanced sarcomas is a clinically relevant end point, this study supports the activity of trabectedin for patients with these malignancies. © 2015 by American Society of Clinical Oncology.

Continuous wound infiltration or epidural analgesia for pain prevention after hepato-pancreato-biliary surgery within an enhanced recovery program (POP-UP trial): study protocol for a randomized controlled trial.

PubMed

Mungroop, Timothy H; Veelo, Denise P; Busch, Olivier R; van Dieren, Susan; van Gulik, Thomas M; Karsten, Tom M; de Castro, Steve M; Godfried, Marc B; Thiel, Bram; Hollmann, Markus W; Lirk, Philipp; Besselink, Marc G

2015-12-09

Postoperative pain prevention is essential for the recovery of surgical patients. Continuous (thoracic) epidural analgesia (CEA) is routinely practiced for major abdominal surgery, but evidence is conflicting on its benefits in this setting. Potential disadvantages of epidural analgesia are a) perioperative hypotension, frequently requiring additional intravenous fluid boluses or prolonged use of vasopressors; b) relatively high failure rates, with periods of inadequate analgesia; and c) the risk of rare but serious, at times persistent, neurologic complications (hematoma and abscess). In recent years, continuous (subfascial) wound infiltration (CWI) plus patient-controlled analgesia (PCA) has been suggested as a safe and reliable alternative, which does not have the previously mentioned disadvantages, but evidence from multicenter trials targeting a specific surgical population is lacking. We hypothesize that CWI+PCA is equally as effective as CEA, without the mentioned disadvantages. POP-UP is a randomized controlled noninferiority multicenter trial, recruiting adult patients scheduled for elective hepato-pancreato-biliary surgery via laparotomy in an enhanced recovery setting. A total of 102 patients are being randomly allocated to CWI+PCA or (P)CEA. Our primary endpoint is the Overall Benefit of Analgesic Score (OBAS), a composite endpoint of pain intensity, opioid-related adverse effects and patient satisfaction, during postoperative days 1 to 5. Secondary endpoints include length of the hospital stay, number of patients with severe pain, and the use of rescue medication. POP-UP is a pragmatic trial that will provide evidence of whether CWI+PCA is noninferior as compared to (P)CEA after elective hepato-pancreato-biliary surgery via laparotomy in an enhanced recovery setting. If this hypothesis is confirmed, this finding could contribute to more widespread implementation of this technique, especially when the described disadvantages of epidural analgesia are less often observed with CWI+PCA. Netherlands Trial Register NTR4948 (registry date 2 January 2015).

Magnetic resonance venography to assess thrombus resolution with edoxaban monotherapy versus parenteral anticoagulation/warfarin for symptomatic deep vein thrombosis: A multicenter feasibility study.

PubMed

Piazza, Gregory; Mani, Venkatesh; Goldhaber, Samuel Z; Grosso, Michael A; Mercuri, Michele; Lanz, Hans J; Schussler, Steven; Hsu, Ching; Chinigo, Amy; Ritchie, Bruce; Nadar, Venkatesh; Cannon, Kevin; Pullman, John; Concha, Mauricio; Schul, Marlin; Fayad, Zahi A

2016-08-01

The feasibility of magnetic resonance venography (MRV) for measuring change in thrombus volume with a novel anticoagulation regimen versus standard anticoagulation in patients with symptomatic deep vein thrombosis (DVT) has not been assessed. Our aim was to study the feasibility of MRV to measure change in thrombus volume in patients with acute symptomatic objectively confirmed proximal DVT in an open-label multicenter trial (edoxaban Thrombus Reduction Imaging Study, eTRIS). We randomized patients in a 2:1 allocation ratio to edoxaban 90 mg/day for 10 days followed by 60 mg/day versus parenteral anticoagulation bridging to warfarin for 3 months. The primary efficacy outcome was a surrogate end point of the relative change in MRV-quantified thrombus volume from baseline to Day 14-21. A total of 85 eligible patients from 26 study sites were randomized to edoxaban monotherapy (n=56) versus parenteral anticoagulation as a 'bridge' to warfarin (n=29). The mean relative change in MRV-quantified thrombus volume from baseline to Day 14-21 was similar in patients treated with edoxaban and parenteral anticoagulation as a 'bridge' to warfarin (-50.1% vs -58.9%; 95% confidence interval of treatment difference, -12.7%, 30.2%). However, thrombus extension was observed in eight patients in the edoxaban monotherapy group and in none in the warfarin group. Rates of recurrent venous thromboembolism (3.6% vs 3.6%, p=0.45) and clinically relevant non-major bleeding (5.4% vs 7.1%, p=0.34) were also similar. No major bleeds occurred in either on-treatment group during the study period. In conclusion, MRV can assess change in thrombus volume in patients with acute DVT randomized to two different anticoagulant regimens.ClinicalTrials.gov IDENTIFIER NCT01662908: INVESTIGATIONAL NEW DRUG IND APPLICATION EDOXABAN IND # 63266. © The Author(s) 2016.

Magnetic resonance venography to assess thrombus resolution with edoxaban monotherapy versus parenteral anticoagulation/warfarin for symptomatic deep vein thrombosis: A multicenter feasibility study

PubMed Central

Piazza, Gregory; Mani, Venkatesh; Goldhaber, Samuel Z; Grosso, Michael A; Mercuri, Michele; Lanz, Hans J; Schussler, Steven; Hsu, Ching; Chinigo, Amy; Ritchie, Bruce; Nadar, Venkatesh; Cannon, Kevin; Pullman, John; Concha, Mauricio; Schul, Marlin; Fayad, Zahi A

2016-01-01

The feasibility of magnetic resonance venography (MRV) for measuring change in thrombus volume with a novel anticoagulation regimen versus standard anticoagulation in patients with symptomatic deep vein thrombosis (DVT) has not been assessed. Our aim was to study the feasibility of MRV to measure change in thrombus volume in patients with acute symptomatic objectively confirmed proximal DVT in an open-label multicenter trial (edoxaban Thrombus Reduction Imaging Study, eTRIS). We randomized patients in a 2:1 allocation ratio to edoxaban 90 mg/day for 10 days followed by 60 mg/day versus parenteral anticoagulation bridging to warfarin for 3 months. The primary efficacy outcome was a surrogate end point of the relative change in MRV-quantified thrombus volume from baseline to Day 14–21. A total of 85 eligible patients from 26 study sites were randomized to edoxaban monotherapy (n=56) versus parenteral anticoagulation as a ‘bridge’ to warfarin (n=29). The mean relative change in MRV-quantified thrombus volume from baseline to Day 14–21 was similar in patients treated with edoxaban and parenteral anticoagulation as a ‘bridge’ to warfarin (−50.1% vs −58.9%; 95% confidence interval of treatment difference, −12.7%, 30.2%). However, thrombus extension was observed in eight patients in the edoxaban monotherapy group and in none in the warfarin group. Rates of recurrent venous thromboembolism (3.6% vs 3.6%, p=0.45) and clinically relevant non-major bleeding (5.4% vs 7.1%, p=0.34) were also similar. No major bleeds occurred in either on-treatment group during the study period. In conclusion, MRV can assess change in thrombus volume in patients with acute DVT randomized to two different anticoagulant regimens. ClinicalTrials.gov Identifier: NCT01662908 Investigational New Drug (IND) Application: Edoxaban IND # 63266 PMID:27165711

Laparoscopic versus hybrid approach for treatment of incisional ventral hernia: a prospective randomized multicenter study of 1-month follow-up results.

PubMed

Ahonen-Siirtola, M; Nevala, T; Vironen, J; Kössi, J; Pinta, T; Niemeläinen, S; Keränen, U; Ward, J; Vento, P; Karvonen, J; Ohtonen, P; Mäkelä, J; Rautio, T

2018-06-07

The seroma rate following laparoscopic incisional ventral hernia repair (LIVHR) is up to 78%. LIVHR is connected to a relatively rare but dangerous complication, enterotomy, especially in cases with complex adhesiolysis. Closure of the fascial defect and extirpation of the hernia sack may reduce the risk of seromas and other hernia-site events. Our aim was to evaluate whether hybrid operation has a lower rate of the early complications compared to the standard LIVHR. This is a multicenter randomized-controlled clinical trial. From November 2012 to May 2015, 193 patients undergoing LIVHR for primary incisional hernia with fascial defect size from 2 to 7 cm were recruited in 11 Finnish hospitals. Patients were randomized to either a laparoscopic (LG) or to a hybrid (HG) repair group. The outcome measures were the incidence of clinically and radiologically detected seromas and their extent 1 month after surgery, peri/postoperative complications, and pain. Bulging was observed by clinical evaluation in 46 (49%) LG patients and in 27 (31%) HG patients (p = 0.022). Ultrasound examination detected more seromas (67 vs. 45%, p = 0.004) and larger seromas (471 vs. 112 cm 3 , p = 0.025) after LG than after HG. In LG, there were 5 (5.3%) enterotomies compared to 1 (1.1%) in HG (p = 0.108). Adhesiolysis was more complex in LG than in HG (26.6 vs. 13.3%, p = 0.028). Patients in HG had higher pain scores on the first postoperative day (VAS 5.2 vs. 4.3, p = 0.019). Closure of the fascial defect and extirpation of the hernia sack reduce seroma formation. In hybrid operations, the risk of enterotomy seems to be lower than in laparoscopic repair, which should be considered in cases with complex adhesions. NCT02542085.

A randomized, multi-center, open-label, phase III study of once-per-cycle DA-3031, a pegylated G-CSF, in comparison with daily filgrastim in patients receiving TAC chemotherapy for breast cancer.

PubMed

Park, K H; Lee, S; Park, J H; Kang, S Y; Kim, H Y; Park, I H; Park, Y H; Im, Y H; Lee, H J; Park, S; Lee, S I; Jung, K H; Kim, Y S; Seo, Jae Hong

2017-02-01

This multi-center, randomized, phase III study was conducted to demonstrate the non-inferiority of DA-3031 compared with daily filgrastim in patients during the first cycle of chemotherapy for breast cancer in terms of the duration of severe neutropenia (DSN). Seventy-four patients with breast cancer who were receiving combination chemotherapy with docetaxel, doxorubicin, and cyclophosphamide (TAC) were enrolled. All participants were randomized to receive either daily subcutaneous injections of filgrastim 100 μg/m 2 /day for up to 10 days or a single subcutaneous injection of DA-3031 at fixed doses of 6 mg on day 2 of each chemotherapy cycle. The mean duration of grade 4 (G4) neutropenia in cycle 1 was 2.08 ± 0.85 days for the filgrastim group and 2.28 ± 1.14 days for the DA-3031 group. The difference between groups was 0.2 ± 1.10 days (95 % confidence interval (CI) = -0.26, 0.66), which supported non-inferiority. No statistically significant differences were observed in nadir absolute neutrophil count (ANC) (154.34/mm 3 and 161.75/mm 3 for the filgrastim and DA-3031 groups, respectively; P = 0.8414) or in time to ANC recovery (10.03 ± 0.75 and 9.83 ± 1.56 days in the filgrastim and DA-3031 groups, respectively; P = 0.0611) during cycle 1. Serious AEs occurred in six (15.8 %) patients receiving filgrastim and in ten (27.8 %) patients receiving DA-3031; however, none was determined to be related to the study drug. DA-3031 and daily filgrastim are similar in regard to DSN and safety in breast cancer patients receiving TAC chemotherapy.

Importance of methodology on (99m)technetium dimercapto-succinic acid scintigraphic image quality: imaging pilot study for RIVUR (Randomized Intervention for Children With Vesicoureteral Reflux) multicenter investigation.

PubMed

Ziessman, Harvey A; Majd, Massoud

2009-07-01

We reviewed our experience with (99m)technetium dimercapto-succinic acid scintigraphy obtained during an imaging pilot study for a multicenter investigation (Randomized Intervention for Children With Vesicoureteral Reflux) of the effectiveness of daily antimicrobial prophylaxis for preventing recurrent urinary tract infection and renal scarring. We analyzed imaging methodology and its relation to diagnostic image quality. (99m)Technetium dimercapto-succinic acid imaging guidelines were provided to participating sites. High-resolution planar imaging with parallel hole or pinhole collimation was required. Two core reviewers evaluated all submitted images. Analysis included appropriate views, presence or lack of patient motion, adequate magnification, sufficient counts and diagnostic image quality. Inter-reader agreement was evaluated. We evaluated 70, (99m)technetium dimercapto-succinic acid studies from 14 institutions. Variability was noted in methodology and image quality. Correlation (r value) between dose administered and patient age was 0.780. For parallel hole collimator imaging good correlation was noted between activity administered and counts (r = 0.800). For pinhole imaging the correlation was poor (r = 0.110). A total of 10 studies (17%) were rejected for quality issues of motion, kidney overlap, inadequate magnification, inadequate counts and poor quality images. The submitting institution was informed and provided with recommendations for improving quality, and resubmission of another study was required. Only 4 studies (6%) were judged differently by the 2 reviewers, and the differences were minor. Methodology and image quality for (99m)technetium dimercapto-succinic acid scintigraphy varied more than expected between institutions. The most common reason for poor image quality was inadequate count acquisition with insufficient attention to the tradeoff between administered dose, length of image acquisition, start time of imaging and resulting image quality. Inter-observer core reader agreement was high. The pilot study ensured good diagnostic quality standardized images for the Randomized Intervention for Children With Vesicoureteral Reflux investigation.

NHash: Randomized N-Gram Hashing for Distributed Generation of Validatable Unique Study Identifiers in Multicenter Research

PubMed Central

Zhang, Guo-Qiang; Tao, Shiqiang; Xing, Guangming; Mozes, Jeno; Zonjy, Bilal; Lhatoo, Samden D

2015-01-01

Background A unique study identifier serves as a key for linking research data about a study subject without revealing protected health information in the identifier. While sufficient for single-site and limited-scale studies, the use of common unique study identifiers has several drawbacks for large multicenter studies, where thousands of research participants may be recruited from multiple sites. An important property of study identifiers is error tolerance (or validatable), in that inadvertent editing mistakes during their transmission and use will most likely result in invalid study identifiers. Objective This paper introduces a novel method called "Randomized N-gram Hashing (NHash)," for generating unique study identifiers in a distributed and validatable fashion, in multicenter research. NHash has a unique set of properties: (1) it is a pseudonym serving the purpose of linking research data about a study participant for research purposes; (2) it can be generated automatically in a completely distributed fashion with virtually no risk for identifier collision; (3) it incorporates a set of cryptographic hash functions based on N-grams, with a combination of additional encryption techniques such as a shift cipher; (d) it is validatable (error tolerant) in the sense that inadvertent edit errors will mostly result in invalid identifiers. Methods NHash consists of 2 phases. First, an intermediate string using randomized N-gram hashing is generated. This string consists of a collection of N-gram hashes f 1, f 2, ..., f k. The input for each function f i has 3 components: a random number r, an integer n, and input data m. The result, f i(r, n, m), is an n-gram of m with a starting position s, which is computed as (r mod |m|), where |m| represents the length of m. The output for Step 1 is the concatenation of the sequence f 1(r 1, n 1, m 1), f 2(r 2, n 2, m 2), ..., f k(r k, n k, m k). In the second phase, the intermediate string generated in Phase 1 is encrypted using techniques such as shift cipher. The result of the encryption, concatenated with the random number r, is the final NHash study identifier. Results We performed experiments using a large synthesized dataset comparing NHash with random strings, and demonstrated neglegible probability for collision. We implemented NHash for the Center for SUDEP Research (CSR), a National Institute for Neurological Disorders and Stroke-funded Center Without Walls for Collaborative Research in the Epilepsies. This multicenter collaboration involves 14 institutions across the United States and Europe, bringing together extensive and diverse expertise to understand sudden unexpected death in epilepsy patients (SUDEP). Conclusions The CSR Data Repository has successfully used NHash to link deidentified multimodal clinical data collected in participating CSR institutions, meeting all desired objectives of NHash. PMID:26554419

Effects of hard mask etch on final topography of advanced phase shift masks

NASA Astrophysics Data System (ADS)

Hortenbach, Olga; Rolff, Haiko; Lajn, Alexander; Baessler, Martin

2017-07-01

Continuous shrinking of the semiconductor device dimensions demands steady improvements of the lithographic resolution on wafer level. These requirements challenge the photomask industry to further improve the mask quality in all relevant printing characteristics. In this paper topography of the Phase Shift Masks (PSM) was investigated. Effects of hard mask etch on phase shift uniformity and mask absorber profile were studied. Design of experiments method (DoE) was used for the process optimization, whereas gas composition, bias power of the hard mask main etch and bias power of the over-etch were varied. In addition, influence of the over-etch time was examined at the end of the experiment. Absorber depth uniformity, sidewall angle (SWA), reactive ion etch lag (RIE lag) and through pitch (TP) dependence were analyzed. Measurements were performed by means of Atomic-force microscopy (AFM) using critical dimension (CD) mode with a boot-shaped tip. Scanning electron microscope (SEM) cross-section images were prepared to verify the profile quality. Finally CD analysis was performed to confirm the optimal etch conditions. Significant dependence of the absorber SWA on hard mask (HM) etch conditions was observed revealing an improvement potential for the mask absorber profile. It was found that hard mask etch can leave a depth footprint in the absorber layer. Thus, the etch depth uniformity of hard mask etch is crucial for achieving a uniform phase shift over the active mask area. The optimized hard mask etch process results in significantly improved mask topography without deterioration of tight CD specifications.

Efficacy and safety of a very-low-protein diet when postponing dialysis in the elderly: a prospective randomized multicenter controlled study.

PubMed

Brunori, Giuliano; Viola, Battista F; Parrinello, Giovanni; De Biase, Vincenzo; Como, Giovanna; Franco, Vincenzo; Garibotto, Giacomo; Zubani, Roberto; Cancarini, Giovanni C

2007-05-01

A supplemented very-low-protein diet (sVLPD) seems to be safe when postponing dialysis therapy. Prospective multicenter randomized controlled study designed to assess the noninferiority of diet versus dialysis in 1-year mortality assessed by using intention-to-treat and per-protocol analysis. Italian uremic patients without diabetes older than 70 years with glomerular filtration rate of 5 to 7 mL/min (0.08 to 0.12 mL/s). Randomization to an sVLPD (diet group) or dialysis. The sVLPD is a vegan diet (35 kcal; proteins, 0.3 g/kg body weight daily) supplemented with keto-analogues, amino acids, and vitamins. Patients following an sVLPD started dialysis therapy in the case of malnutrition, intractable fluid overload, hyperkalemia, or appearance of uremic symptoms. Mortality, hospitalization, and metabolic markers. 56 patients were randomly assigned to each group, median follow-up was 26.5 months (interquartile range, 40), and patients in the diet group spent a median of 10.7 months (interquartile range, 11) following an sVLPD. Forty patients in the diet group started dialysis treatment because of either fluid overload or hyperkalemia. There were 31 deaths (55%) in the dialysis group and 28 deaths (50%) in the diet group. One-year observed survival rates at intention to treat were 83.7% (95% confidence interval [CI], 74.5 to 94.0) in the dialysis group versus 87.3% (95% CI, 78.9 to 96.5) in the diet group (log-rank test for noninferiority, P < 0.001; for superiority, P = 0.6): the difference in survival was -3.6% (95% CI, -17 to +10; P = 0.002). The hazard ratio for hospitalization was 1.50 for the dialysis group (95% CI, 1.11 to 2.01; P < 0.01). The unblinded nature of the study, exclusion of patients with diabetes, and incomplete enrollment. An sVLPD was effective and safe when postponing dialysis treatment in elderly patients without diabetes.

Protocolized fluid therapy in brain-dead donors: the multicenter randomized MOnIToR trial.

PubMed

Al-Khafaji, Ali; Elder, Michele; Lebovitz, Daniel J; Murugan, Raghavan; Souter, Michael; Stuart, Susan; Wahed, Abdus S; Keebler, Ben; Dils, Dorrie; Mitchell, Stephanie; Shutterly, Kurt; Wilkerson, Dawn; Pearse, Rupert; Kellum, John A

2015-03-01

Critical shortages of organs for transplantation jeopardize many lives. Observational data suggest that better fluid management for deceased organ donors could increase organ recovery. We conducted the first large multicenter randomized trial in brain-dead donors to determine whether protocolized fluid therapy increases the number of organs transplanted. We randomly assigned donors to either protocolized or usual care in eight organ procurement organizations. A "protocol-guided fluid therapy" algorithm targeting the cardiac index, mean arterial pressure and pulse pressure variation was used. Our primary outcome was the number of organs transplanted per donor, and our primary analysis was intention to treat. Secondary analyses included: (1) modified intention to treat where only subjects able to receive the intervention were included and (2) 12-month survival in transplant recipients. The study was stopped early. We enrolled 556 donors: 279 protocolized care and 277 usual care. Groups had similar characteristics at baseline. The study protocol could be implemented in 76 % of subjects randomized to the intervention. There was no significant difference in mean number of organs transplanted per donor: 3.39 organs per donor (95 % CI 3.14-3.63) with protocolized care compared to 3.29 usual care (95 % CI 3.04-3.54; mean difference, 0.1, 95 % CI -0.25 to 0.45; p = 0.56). In modified intention-to-treat analysis the mean number of organs increased (3.52 organs per donor, 95 % CI 3.23-3.8), but not statistically significantly (mean difference, 0.23, 95 % CI -0.15 to 0.61; p = 0.23). Among the 1,430 recipients of organs from study subjects with data available, 56 deaths (7.8 %) occurred in the protocolized care arm and 56 (7.9 %) in the usual care arm in the first year (hazard ratio: 0.97, p = 0.86). In brain-dead organ donors, protocol-guided fluid therapy compared to usual care may not increase the number of organs transplanted per donor.

Development for 2D pattern quantification method on mask and wafer

NASA Astrophysics Data System (ADS)

Matsuoka, Ryoichi; Mito, Hiroaki; Toyoda, Yasutaka; Wang, Zhigang

2010-03-01

We have developed the effective method of mask and silicon 2-dimensional metrology. The aim of this method is evaluating the performance of the silicon corresponding to Hotspot on a mask. The method adopts a metrology management system based on DBM (Design Based Metrology). This is the high accurate contouring created by an edge detection algorithm used in mask CD-SEM and silicon CD-SEM. Currently, as semiconductor manufacture moves towards even smaller feature size, this necessitates more aggressive optical proximity correction (OPC) to drive the super-resolution technology (RET). In other words, there is a trade-off between highly precise RET and mask manufacture, and this has a big impact on the semiconductor market that centers on the mask business. 2-dimensional Shape quantification is important as optimal solution over these problems. Although 1-dimensional shape measurement has been performed by the conventional technique, 2-dimensional shape management is needed in the mass production line under the influence of RET. We developed the technique of analyzing distribution of shape edge performance as the shape management technique. On the other hand, there is roughness in the silicon shape made from a mass-production line. Moreover, there is variation in the silicon shape. For this reason, quantification of silicon shape is important, in order to estimate the performance of a pattern. In order to quantify, the same shape is equalized in two dimensions. And the method of evaluating based on the shape is popular. In this study, we conducted experiments for averaging method of the pattern (Measurement Based Contouring) as two-dimensional mask and silicon evaluation technique. That is, observation of the identical position of a mask and a silicon was considered. It is possible to analyze variability of the edge of the same position with high precision. The result proved its detection accuracy and reliability of variability on two-dimensional pattern (mask and silicon) and is adaptable to following fields of mask quality management. - Estimate of the correlativity of shape variability and a process margin. - Determination of two-dimensional variability of pattern. - Verification of the performance of the pattern of various kinds of Hotspots. In this report, we introduce the experimental results and the application. We expect that the mask measurement and the shape control on mask production will make a huge contribution to mask yield-enhancement and that the DFM solution for mask quality control process will become much more important technology than ever. It is very important to observe the shape of the same location of Design, Mask, and Silicon in such a viewpoint.

Film loss-free cleaning chemicals for EUV mask lifetime elongation developed through combinatorial chemical screening

NASA Astrophysics Data System (ADS)

Choi, Jaehyuck; Kim, Jinsu; Lowe, Jeff; Dattilo, Davide; Koh, Soowan; Choi, Jun Yeol; Dietze, Uwe; Shoki, Tsutomu; Kim, Byung Gook; Jeon, Chan-Uk

2015-10-01

EUV masks include many different layers of various materials rarely used in optical masks, and each layer of material has a particular role in enhancing the performance of EUV lithography. Therefore, it is crucial to understand how the mask quality and patterning performance can change during mask fabrication, EUV exposure, maintenance cleaning, shipping, or storage. SPM (Sulfuric acid peroxide mixture) which has been extensively used for acid cleaning of photomask and wafer has serious drawback for EUV mask cleaning. It shows severe film loss of tantalum-based absorber layers and limited removal efficiency of EUV-generated carbon contaminants on EUV mask surface. Here, we introduce such novel cleaning chemicals developed for EUV mask as almost film loss free for various layers of the mask and superior carbon removal performance. Combinatorial chemical screening methods allowed us to screen several hundred combinations of various chemistries and additives under several different process conditions of temperature and time, eventually leading to development of the best chemistry selections for EUV mask cleaning. Recently, there have been many activities for the development of EUV pellicle, driven by ASML and core EUV scanner customer companies. It is still important to obtain film-loss free cleaning chemicals because cleaning cycle of EUV mask should be much faster than that of optic mask mainly due to EUV pellicle lifetime. More frequent cleaning, combined with the adoption of new materials for EUV masks, necessitates that mask manufacturers closely examine the performance change of EUV masks during cleaning process. We have investigated EUV mask quality changes and film losses during 50 cleaning cycles using new chemicals as well as particle and carbon contaminant removal characteristics. We have observed that the performance of new chemicals developed is superior to current SPM or relevant cleaning chemicals for EUV mask cleaning and EUV mask lifetime elongation.

The use of masks and respirators to prevent transmission of influenza: a systematic review of the scientific evidence

PubMed Central

bin‐Reza, Faisal; Lopez Chavarrias, Vicente; Nicoll, Angus; Chamberland, Mary E.

2011-01-01

Please cite this paper as: bin‐Reza et al. (2012) The use of masks and respirators to prevent transmission of influenza: a systematic review of the scientific evidence. Influenza and Other Respiratory Viruses 6(4), 257–267. There are limited data on the use of masks and respirators to reduce transmission of influenza. A systematic review was undertaken to help inform pandemic influenza guidance in the United Kingdom. The initial review was performed in November 2009 and updated in June 2010 and January 2011. Inclusion criteria included randomised controlled trials and quasi‐experimental and observational studies of humans published in English with an outcome of laboratory‐confirmed or clinically‐diagnosed influenza and other viral respiratory infections. There were 17 eligible studies. Six of eight randomised controlled trials found no significant differences between control and intervention groups (masks with or without hand hygiene; N95/P2 respirators). One household trial found that mask wearing coupled with hand sanitiser use reduced secondary transmission of upper respiratory infection/influenza‐like illness/laboratory‐confirmed influenza compared with education; hand sanitiser alone resulted in no reduction. One hospital‐based trial found a lower rate of clinical respiratory illness associated with non‐fit‐tested N95 respirator use compared with medical masks. Eight of nine retrospective observational studies found that mask and/or respirator use was independently associated with a reduced risk of severe acute respiratory syndrome (SARS). Findings, however, may not be applicable to influenza and many studies were suboptimal. None of the studies established a conclusive relationship between mask/respirator use and protection against influenza infection. Some evidence suggests that mask use is best undertaken as part of a package of personal protection especially hand hygiene. The effectiveness of masks and respirators is likely linked to early, consistent and correct usage. PMID:22188875

Reduction of shunt obstructions by using a peel-away sheath technique? A multicenter prospective randomized trial.

PubMed

Kehler, Uwe; Langer, Niels; Gliemroth, Jan; Meier, Ullrich; Lemcke, Johannes; Sprung, Christian; Schlosser, Hans-Georg; Kiefer, Michael; Eymann, Regina; Heese, Oliver

2012-05-01

Shunt obstructions may partly be caused by brain debris, which intrude into the ventricular catheter during ventricle puncture. Avoiding contact between the catheter and brain tissue, by using a peel-away sheath, should reduce the number of shunt failures caused by obstruction. To test this hypothesis, we conducted a randomized, prospective multicenter study. 201 patients from 6 different neurosurgical centers in Germany receiving a ventriculo-peritoneal shunt were included in this study. Of these, 177 patients completed a 1-year follow-up period. Surgery was randomized in a 1 to 1 fashion, such that out of 177 procedures, 91 were performed using a peel-away sheath and 86 were performed without. The rate of surgical re-interventions and shunt obstructions within a 12-month period was recorded. Within 1 year post-surgery, 17 shunt obstructions (9.6%) leading to shunt revisions were recorded. However, no difference was found between surgeries performed using a peel-away sheath (9.9%) or not (9.3%). The overall shunt infection rate was 2.8% and the shunt revision rate for overdrainage was 3.9%. The theoretical advantages attributed to the use of a peel-away sheath to introduce a ventricular catheter could not be confirmed in this randomized study, suggesting that the proposed role of brain debris in shunt obstructions may be overestimated. Copyright © 2011 Elsevier B.V. All rights reserved.

Multicenter, randomized, controlled trial of virtual-reality simulator training in acquisition of competency in colonoscopy.

PubMed

Cohen, Jonathan; Cohen, Seth A; Vora, Kinjal C; Xue, Xiaonan; Burdick, J Steven; Bank, Simmy; Bini, Edmund J; Bodenheimer, Henry; Cerulli, Maurice; Gerdes, Hans; Greenwald, David; Gress, Frank; Grosman, Irwin; Hawes, Robert; Mullin, Gerard; Mullen, Gerard; Schnoll-Sussman, Felice; Starpoli, Anthony; Stevens, Peter; Tenner, Scott; Villanueva, Gerald

2006-09-01

The GI Mentor is a virtual reality simulator that uses force feedback technology to create a realistic training experience. To define the benefit of training on the GI Mentor on competency acquisition in colonoscopy. Randomized, controlled, blinded, multicenter trial. Academic medical centers with accredited gastroenterology training programs. First-year GI fellows. Subjects were randomized to receive 10 hours of unsupervised training on the GI Mentor or no simulator experience during the first 8 weeks of fellowship. After this period, both groups began performing real colonoscopies. The first 200 colonoscopies performed by each fellow were graded by proctors to measure technical and cognitive success, and patient comfort level during the procedure. A mixed-effects model comparison between the 2 groups of objective and subjective competency scores and patient discomfort in the performance of real colonoscopies over time. Forty-five fellows were randomized from 16 hospitals over 2 years. Fellows in the simulator group had significantly higher objective competency rates during the first 100 cases. A mixed-effects model demonstrated a higher objective competence overall in the simulator group (P < .0001), with the difference between groups being significantly greater during the first 80 cases performed. The median number of cases needed to reach 90% competency was 160 in both groups. The patient comfort level was similar. Fellows who underwent GI Mentor training performed significantly better during the early phase of real colonoscopy training.

Masking Release in Children and Adults With Hearing Loss When Using Amplification

PubMed Central

McCreery, Ryan; Kopun, Judy; Lewis, Dawna; Alexander, Joshua; Stelmachowicz, Patricia

2016-01-01

Purpose This study compared masking release for adults and children with normal hearing and hearing loss. For the participants with hearing loss, masking release using simulated hearing aid amplification with 2 different compression speeds (slow, fast) was compared. Method Sentence recognition in unmodulated noise was compared with recognition in modulated noise (masking release). Recognition was measured for participants with hearing loss using individualized amplification via the hearing-aid simulator. Results Adults with hearing loss showed greater masking release than the children with hearing loss. Average masking release was small (1 dB) and did not depend on hearing status. Masking release was comparable for slow and fast compression. Conclusions The use of amplification in this study contrasts with previous studies that did not use amplification. The results suggest that when differences in audibility are reduced, participants with hearing loss may be able to take advantage of dips in the noise levels, similar to participants with normal hearing. Although children required a more favorable signal-to-noise ratio than adults for both unmodulated and modulated noise, masking release was not statistically different. However, the ability to detect a difference may have been limited by the small amount of masking release observed. PMID:26540194

Self-masking: Listening during vocalization. Normal hearing.

PubMed

Borg, Erik; Bergkvist, Christina; Gustafsson, Dan

2009-06-01

What underlying mechanisms are involved in the ability to talk and listen simultaneously and what role does self-masking play under conditions of hearing impairment? The purpose of the present series of studies is to describe a technique for assessment of masked thresholds during vocalization, to describe normative data for males and females, and to focus on hearing impairment. The masking effect of vocalized [a:] on narrow-band noise pulses (250-8000 Hz) was studied using the maximum vocalization method. An amplitude-modulated series of sound pulses, which sounded like a steam engine, was masked until the criterion of halving the perceived pulse rate was reached. For masking of continuous reading, a just-follow-conversation criterion was applied. Intra-session test-retest reproducibility and inter-session variability were calculated. The results showed that female voices were more efficient in masking high frequency noise bursts than male voices and more efficient in masking both a male and a female test reading. The male had to vocalize 4 dBA louder than the female to produce the same masking effect on the test reading. It is concluded that the method is relatively simple to apply and has small intra-session and fair inter-session variability. Interesting gender differences were observed.

Face mask use by patients in primary care.

PubMed

Tischendorf, Jessica S; Temte, Jonathan L

2012-02-01

Face masks are recommended for patients with respiratory symptoms to reduce influenza transmission. Little knowledge exists regarding actual utilization and acceptance of face masks in primary care. Compare distribution of face masks to clinic and community trends in respiratory infection (RI) and influenza-like illness (ILI); estimate the annual need for face masks in primary care. Retrospective observational study of practice data from a 31-week period starting in October 2009. Family practice clinic in Madison, Wis. Patients with fever, cough, or other respiratory symptoms as evaluated by reception staff. Age, sex, and weekly counts of individuals receiving a face mask, as well as counts of RI and ILI patients based on ICD-9 coding from 27 statewide clinics. Face mask counts were 80% of RI counts for the clinic and reflected the demographics of the clinic population. Distribution was correlated to prevalence of RI (R = 0.783, P < 0.001) and ILI (R = 0.632, P < 0.001). Annually, 8% of clinic visits were for RI. The high percentage of face mask use among RI patients reflects the feasibility of this intervention to help control influenza transmission in a primary care setting. Using the present data, clinics can estimate the annual need for face masks.

Auditory processing efficiency deficits in children with developmental language impairments

NASA Astrophysics Data System (ADS)

Hartley, Douglas E. H.; Moore, David R.

2002-12-01

The ``temporal processing hypothesis'' suggests that individuals with specific language impairments (SLIs) and dyslexia have severe deficits in processing rapidly presented or brief sensory information, both within the auditory and visual domains. This hypothesis has been supported through evidence that language-impaired individuals have excess auditory backward masking. This paper presents an analysis of masking results from several studies in terms of a model of temporal resolution. Results from this modeling suggest that the masking results can be better explained by an ``auditory efficiency'' hypothesis. If impaired or immature listeners have a normal temporal window, but require a higher signal-to-noise level (poor processing efficiency), this hypothesis predicts the observed small deficits in the simultaneous masking task, and the much larger deficits in backward and forward masking tasks amongst those listeners. The difference in performance on these masking tasks is predictable from the compressive nonlinearity of the basilar membrane. The model also correctly predicts that backward masking (i) is more prone to training effects, (ii) has greater inter- and intrasubject variability, and (iii) increases less with masker level than do other masking tasks. These findings provide a new perspective on the mechanisms underlying communication disorders and auditory masking.

Interim analysis of postoperative chemoradiotherapy with capecitabine and oxaliplatin versus capecitabine alone for pathological stage II and III rectal cancer: a randomized multicenter phase III trial.

PubMed

Feng, Yan-Ru; Zhu, Yuan; Liu, Lu-Ying; Wang, Wei-Hu; Wang, Shu-Lian; Song, Yong-Wen; Wang, Xin; Tang, Yuan; Liu, Yue-Ping; Ren, Hua; Fang, Hui; Zhang, Shi-Ping; Liu, Xin-Fan; Yu, Zi-Hao; Li, Ye-Xiong; Jin, Jing

2016-05-03

The aim of this study is to present an interim analysis of a phase III trial (NCT00714077) of postoperative concurrent capecitabine and radiotherapy with or without oxaliplatin for pathological stage II and III rectal cancer. Patients with pathologically confirmed stage II and III rectal cancer were randomized to either radiotherapy with concurrent capecitabine (Cap-RT group) or with capecitabine and oxaliplatin (Capox-RT group). The primary endpoint was 3-year disease-free survival rate (DFS). The 3-year DFS rate was 73.9% in the Capox-RT group and 71.6% in the Cap-RT group (HR 0.92, p = 0.647), respectively. No significant difference was observed in overall survival, cumulative incidence of local recurrence and distant metastasis between the two groups (p > 0.05). More grade 3-4 acute toxicity was observed in the Capox-RT group than in the Cap-RT group (38.1% vs. 29.2%, p = 0.041). Inclusion of oxaliplatin in the capecitabine-based postoperative regimen did not improve DFS but increased toxicities for pathological stage II and III rectal cancer in this interim analysis.

Determining the energetic and informational components of speech-on-speech masking

PubMed Central

Kidd, Gerald; Mason, Christine R.; Swaminathan, Jayaganesh; Roverud, Elin; Clayton, Kameron K.; Best, Virginia

2016-01-01

Identification of target speech was studied under masked conditions consisting of two or four independent speech maskers. In the reference conditions, the maskers were colocated with the target, the masker talkers were the same sex as the target, and the masker speech was intelligible. The comparison conditions, intended to provide release from masking, included different-sex target and masker talkers, time-reversal of the masker speech, and spatial separation of the maskers from the target. Significant release from masking was found for all comparison conditions. To determine whether these reductions in masking could be attributed to differences in energetic masking, ideal time-frequency segregation (ITFS) processing was applied so that the time-frequency units where the masker energy dominated the target energy were removed. The remaining target-dominated “glimpses” were reassembled as the stimulus. Speech reception thresholds measured using these resynthesized ITFS-processed stimuli were the same for the reference and comparison conditions supporting the conclusion that the amount of energetic masking across conditions was the same. These results indicated that the large release from masking found under all comparison conditions was due primarily to a reduction in informational masking. Furthermore, the large individual differences observed generally were correlated across the three masking release conditions. PMID:27475139

Masked polycythaemia vera: presenting features, response to treatment and clinical outcomes.

PubMed

Alvarez-Larrán, Alberto; Angona, Anna; Ancochea, Agueda; García-Pallarols, Francesc; Fernández, Concepción; Longarón, Raquel; Bellosillo, Beatriz; Besses, Carlos

2016-01-01

Masked polycythaemia vera (PV) has been proposed as a new entity with poorer outcome than overt PV. In this study, the initial clinical and laboratory characteristics, response to treatment and outcome of masked and overt PV were compared using red cell mass and haemoglobin or haematocrit levels for the distinction between both entities. Sixty-eight of 151 PV patients (45%) were classified as masked PV according to World Health Organisation diagnostic criteria, whereas 16 (11%) were classified as masked PV using the British Committee for Standards in Haematology (BCSH). In comparison with overt PV, a higher platelet count and a lower JAK2V617F allele burden at diagnosis were observed in masked PV. Patients with masked PV needed lower phlebotomies and responded faster to hydroxcarbamide than those with overt PV. Complete haematological response was more frequently achieved in masked than in overt PV (79% vs. 58%, P = 0.001). There were no significant differences in the duration of haematological response, the rate of resistance or intolerance to hydroxycarbamide and the probability of molecular response according to type of PV (masked vs. overt). Overall survival, rate of thrombosis and major bleeding, and probability of transformation was superimposable among patients with masked and overt PV. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A new predictive model for continuous positive airway pressure in the treatment of obstructive sleep apnea.

PubMed

Ebben, Matthew R; Narizhnaya, Mariya; Krieger, Ana C

2017-05-01

Numerous mathematical formulas have been developed to determine continuous positive airway pressure (CPAP) without an in-laboratory titration study. Recent studies have shown that style of CPAP mask can affect the optimal pressure requirement. However, none of the current models take mask style into account. Therefore, the goal of this study was to develop new predictive models of CPAP that take into account the style of mask interface. Data from 200 subjects with attended CPAP titrations during overnight polysomnograms using nasal masks and 132 subjects using oronasal masks were randomized and split into either a model development or validation group. Predictive models were then created in each model development group and the accuracy of the models was then tested in the model validation groups. The correlation between our new oronasal model and laboratory determined optimal CPAP was significant, r = 0.61, p < 0.001. Our nasal formula was also significantly related to laboratory determined optimal CPAP, r = 0.35, p < 0.001. The oronasal model created in our study significantly outperformed the original CPAP predictive model developed by Miljeteig and Hoffstein, z = 1.99, p < 0.05. The predictive performance of our new nasal model did not differ significantly from Miljeteig and Hoffstein's original model, z = -0.16, p < 0.90. The best predictors for the nasal mask group were AHI, lowest SaO2, and neck size, whereas the top predictors in the oronasal group were AHI and lowest SaO2. Our data show that predictive models of CPAP that take into account mask style can significantly improve the formula's accuracy. Most of the past models likely focused on model development with nasal masks (mask style used for model development was not typically reported in previous investigations) and are not well suited for patients using an oronasal interface. Our new oronasal CPAP prediction equation produced significantly improved performance compared to the well-known Miljeteig and Hoffstein formula in patients titrated on CPAP with an oronasal mask and was also significantly related to laboratory determined optimal CPAP.

Efficacy of electroacupuncture for symptoms of menopausal transition: study protocol for a randomized controlled trial.

PubMed

Liu, Zhishun; Wang, Yang; Xu, Huanfang; Wu, Jiani; He, Liyun; Jiang, John Yi; Yan, Shiyan; Du, Ruosang; Liu, Baoyan

2014-06-21

Previous studies have shown that acupuncture can alleviate postmenopausal symptoms, such as hot flashes, but few studies have assessed symptoms during the menopausal transition (MT) period. Thus, the effect of acupuncture upon MT symptoms is unclear. We designed a large-scale trial aimed at evaluating the efficacy of electroacupuncture for MT symptoms compared with sham electroacupuncture and at observing the safety of electroacupuncture. In this multicenter randomized controlled trial, 360 women will be randomized to either an electroacupuncture group or a sham electroacupuncture group. During the 8-week-long treatment, a menopause rating scale, average 24-hour hot flash score, Menopause-Specific Quality of Life Questionnaire score, and level of female hormones will be observed. Follow-ups at the 20th and 32nd week will be made. Though there is no completely inert placebo acupuncture and blinding is difficult in acupuncture trials, the placebo effect of EA can still be partially excluded in this study. For the placebo control, we use non-points and a tailor-made sham needle. This needle is different from a retractable needle, which is usually used for sham acupuncture. The needle in this trial is more simply constructed and more acceptable to Chinese people. We expect to evaluate the efficacy of electroacupuncture for MT symptoms and clarify its effect on these symptoms. ClinicalTrials.gov Identifier: NCT01849172 (Date of registration: 05/05/2013).

Effectiveness of the head CT choice decision aid in parents of children with minor head trauma: study protocol for a multicenter randomized trial

PubMed Central

2014-01-01

Background Blunt head trauma is a common cause of death and disability in children worldwide. Cranial computed tomography (CT), the reference standard for the diagnosis of traumatic brain injury (TBI), exposes children to ionizing radiation which has been linked to the development of brain tumors, leukemia, and other cancers. We describe the methods used to develop and test the effectiveness of a decision aid to facilitate shared decision-making with parents regarding whether to obtain a head CT scan or to further observe their child at home. Methods/Design This is a protocol for a multicenter clinician-level parallel randomized trial to compare an intervention group receiving a decision aid, ‘Head CT Choice’, to a control group receiving usual care. The trial will be conducted at five diverse emergency departments (EDs) in Minnesota and California. Clinicians will be randomized to decision aid or usual care. Parents visiting the ED with children who are less than 18-years-old, have experienced blunt head trauma within 24 hours, and have one or two risk factors for clinically-important TBI (ciTBI) from the Pediatric Emergency Care Applied Research Network head injury clinical prediction rules will be eligible for enrollment. We will measure the effect of Head CT Choice on: (1) parent knowledge regarding their child’s risk of ciTBI, the available diagnostic options, and the risks of radiation exposure associated with a cranial CT scan (primary outcome); (2) parent engagement in the decision-making process; (3) the degree of conflict parents experience related to feeling uninformed; (4) patient and clinician satisfaction with the decision made; (5) the rate of ciTBI at seven days; (6) the proportion of patients in whom a cranial CT scan is obtained; and (7) seven-day healthcare utilization. To capture these outcomes, we will administer parent and clinician surveys immediately after each clinical encounter, obtain video recordings of parent-clinician discussions, administer parent healthcare utilization diaries, analyze hospital billing records, review the electronic medical record, and conduct telephone follow-up. Discussion This multicenter trial will robustly assess the effectiveness of a decision aid on patient-centered outcomes, safety, and healthcare utilization in parents of children with minor head trauma in five diverse EDs. Trial registration ClinicalTrials.gov registration number: NCT02063087. Registration date February 13, 2014. PMID:24965659

Rationale, design and methods of the HEALTHY study behavior intervention component

USDA-ARS?s Scientific Manuscript database

HEALTHY was a multi-center primary prevention trial designed to reduce risk factors for type 2 diabetes in adolescents. Seven centers each recruited six middle schools that were randomized to either intervention or control. The HEALTHY intervention integrated multiple components in nutrition, physic...

Masking reduces orientation selectivity in rat visual cortex

PubMed Central

Alwis, Dasuni S.; Richards, Katrina L.

2016-01-01

In visual masking the perception of a target stimulus is impaired by a preceding (forward) or succeeding (backward) mask stimulus. The illusion is of interest because it allows uncoupling of the physical stimulus, its neuronal representation, and its perception. To understand the neuronal correlates of masking, we examined how masks affected the neuronal responses to oriented target stimuli in the primary visual cortex (V1) of anesthetized rats (n = 37). Target stimuli were circular gratings with 12 orientations; mask stimuli were plaids created as a binarized sum of all possible target orientations. Spatially, masks were presented either overlapping or surrounding the target. Temporally, targets and masks were presented for 33 ms, but the stimulus onset asynchrony (SOA) of their relative appearance was varied. For the first time, we examine how spatially overlapping and center-surround masking affect orientation discriminability (rather than visibility) in V1. Regardless of the spatial or temporal arrangement of stimuli, the greatest reductions in firing rate and orientation selectivity occurred for the shortest SOAs. Interestingly, analyses conducted separately for transient and sustained target response components showed that changes in orientation selectivity do not always coincide with changes in firing rate. Given the near-instantaneous reductions observed in orientation selectivity even when target and mask do not spatially overlap, we suggest that monotonic visual masking is explained by a combination of neural integration and lateral inhibition. PMID:27535373

Specific immunotherapy for rhinitis and asthma with a subcutaneous hypoallergenic high-dose house dust mite extract: results of a 9-month therapy.

PubMed

El-Qutob, David; Moreno, Francisco; Subtil-Rodríguez, Alicia

2016-07-01

Effectiveness of a 9-month specific immunotherapy with a subcutaneous hypoallergenic high-dose house dust mite extract to reduce allergic symptoms as perceived by patients and physicians was assessed. An observational, retrospective, multicenter study was carried out in patients diagnosed with asthma and/or rhinitis caused by house dust mites having started specific immunotherapy with Acaroid(®). Primary end point was perceived effectiveness. A total of 409 patients were included. According to physician-completed visual analogue scale, a 58.1% clinical improvement was observed. Patient-completed visual analogue scale showed a 69.8% clinical improvement. The need for unscheduled/emergency healthcare, as an indication of poor quality of life, showed a significant reduction. Our results confirm in a real-world setting the findings from randomized clinical trials of high-dose house dust mites allergoid immunotherapy with a subcutaneous hypoallergenic high-dose house dust mite extract.

[Therapy of rapid ejaculation using dietary supplement "NeyroDoz": results of a multicenter non-randomized clinical study].

PubMed

Kamalov, A A; Aboian, I A; Sitdykova, M É; Tsukanov, A Iu; Teodorovich, O V; Medvedev, V L; Komiakov, B K; Zhuravlev, V N; Novikov, A I; Erkovich, A A; Okhobotov, D A; Karpov, V K; Zubkov, A Iu

2013-01-01

The main aim of the study was to determine the effectiveness of a multicomponent dietary supplement NeyroDoz in patients with rapid ejaculation. We examined 50 patients with rapid ejaculation (premature ejaculation), who were recruited in 9 clinical centers in different regions of Russia. These patients received NeyroDoz, 2 capsules twice a day for one month, followed by a control observation for 1 month. In study group of patients, symptomatic improvement was achieved in 45 (90%) of 50 patients at 4-week observation target date. In assessing the impact of NeyroDoz on different groups of symptoms, it was found that it significantly increases the average time of sexual intercourse by 2 times, increases the orgasm brightness, reduces the severity of psychosomatic component and has a positive effect on all components of the copulative cycle. In assessing the afterimpression, this effect was maintained throughout the period of follow-up.

Shadows Alter Facial Expressions of Noh Masks

PubMed Central

Kawai, Nobuyuki; Miyata, Hiromitsu; Nishimura, Ritsuko; Okanoya, Kazuo

2013-01-01

Background A Noh mask, worn by expert actors during performance on the Japanese traditional Noh drama, conveys various emotional expressions despite its fixed physical properties. How does the mask change its expressions? Shadows change subtly during the actual Noh drama, which plays a key role in creating elusive artistic enchantment. We here describe evidence from two experiments regarding how attached shadows of the Noh masks influence the observers’ recognition of the emotional expressions. Methodology/Principal Findings In Experiment 1, neutral-faced Noh masks having the attached shadows of the happy/sad masks were recognized as bearing happy/sad expressions, respectively. This was true for all four types of masks each of which represented a character differing in sex and age, even though the original characteristics of the masks also greatly influenced the evaluation of emotions. Experiment 2 further revealed that frontal Noh mask images having shadows of upward/downward tilted masks were evaluated as sad/happy, respectively. This was consistent with outcomes from preceding studies using actually tilted Noh mask images. Conclusions/Significance Results from the two experiments concur that purely manipulating attached shadows of the different types of Noh masks significantly alters the emotion recognition. These findings go in line with the mysterious facial expressions observed in Western paintings, such as the elusive qualities of Mona Lisa’s smile. They also agree with the aesthetic principle of Japanese traditional art “yugen (profound grace and subtlety)”, which highly appreciates subtle emotional expressions in the darkness. PMID:23940748

A 24-Week, Randomized, Controlled Study to Evaluate the Tolerability, Safety and Efficacy of 2 Different Titration Schemes of the Rivastigmine Patch in Japanese Patients with Mild to Moderate Alzheimer's Disease.

PubMed

Nakamura, Yu; Strohmaier, Christine; Tamura, Kaoru; Kataoka, Naoko; Nakano, Masayuki; Oda, Shoichiro; Nishimura, Kazuma; Homma, Akira

2015-01-01

To investigate whether 1-step titration of the rivastigmine patch (initiated at 5 cm(2) and titrated to 10 cm(2) after 4 weeks) is well tolerated in Japanese patients with Alzheimer's disease (AD) as compared to 3-step titration (initiated at 2.5 cm(2) and titrated by 2.5 cm(2) every 4 weeks to 10 cm(2)). A 24-week, multicenter, randomized, double-blind study was conducted in Japan between July 2012 and May 2014. Patients with mild to moderate AD aged 50-85 years were randomized 1:1 to 1-step or 3-step titration of the rivastigmine once-daily patch. The primary endpoint was the proportion of patients with adverse events leading to discontinuation. Of 216 patients randomized, 215 (1-step, n = 107; 3-step, n = 108) were included in the safety analysis. The primary endpoint outcome was 15.0% in the 1-step group and 18.5% in the 3-step group. The observed treatment difference was -3.6% (95% confidence interval: -17.0, 9.6), falling within the prespecified acceptance range. The tolerability of two different titration schemes was similar in Japanese patients with AD.

A 24-Week, Randomized, Controlled Study to Evaluate the Tolerability, Safety and Efficacy of 2 Different Titration Schemes of the Rivastigmine Patch in Japanese Patients with Mild to Moderate Alzheimer's Disease

PubMed Central

Nakamura, Yu; Strohmaier, Christine; Tamura, Kaoru; Kataoka, Naoko; Nakano, Masayuki; Oda, Shoichiro; Nishimura, Kazuma; Homma, Akira

2015-01-01

Aim To investigate whether 1-step titration of the rivastigmine patch (initiated at 5 cm2 and titrated to 10 cm2 after 4 weeks) is well tolerated in Japanese patients with Alzheimer's disease (AD) as compared to 3-step titration (initiated at 2.5 cm2 and titrated by 2.5 cm2 every 4 weeks to 10 cm2). Methods A 24-week, multicenter, randomized, double-blind study was conducted in Japan between July 2012 and May 2014. Patients with mild to moderate AD aged 50-85 years were randomized 1:1 to 1-step or 3-step titration of the rivastigmine once-daily patch. The primary endpoint was the proportion of patients with adverse events leading to discontinuation. Results Of 216 patients randomized, 215 (1-step, n = 107; 3-step, n = 108) were included in the safety analysis. The primary endpoint outcome was 15.0% in the 1-step group and 18.5% in the 3-step group. The observed treatment difference was −3.6% (95% confidence interval: −17.0, 9.6), falling within the prespecified acceptance range. Conclusion The tolerability of two different titration schemes was similar in Japanese patients with AD. PMID:26557135

Observation of EUVL mask using coherent EUV scatterometry microscope with high-harmonic-generation EUV source

NASA Astrophysics Data System (ADS)

Mamezaki, Daiki; Harada, Tetsuo; Nagata, Yutaka; Watanabe, Takeo

2017-07-01

In extreme ultraviolet (EUV) lithography, development of review tools for EUV mask pattern and phase defect at working wavelength of 13.5 nm is required. The EUV mask is composed of an absorber pattern (50 - 70 nm thick) and Mo/Si multilayer (280 nm thick) on a glass substrate. This mask pattern seems three-dimensional (3D) structure. This 3D structure would modulate EUV reflection phase, which would cause focus and pattern shifts. Thus, EUV phase imaging is important to evaluate this phase modulation. We have developed coherent EUV scatterometry microscope (CSM), which is a simple microscope without objective optics. EUV phase and intensity image are reconstructed with diffraction images by ptychography with coherent EUV illumination. The high-harmonic-generation (HHG) EUV source was employed for standalone CSM system. In this study, we updated HHG system of pump-laser reduction and gas-pressure control. Two types of EUV mask absorber patterns were observed. An 88-nm lines-and-spaces and a cross-line patterns were clearly reconstructed by ptychography. In addition, a natural defect with 2-μm diameter on the cross-line was well reconstructed. This demonstrated the high capability of the standalone CSM, which system will be used in the factories, such as mask shops and semiconductor fabrication plants.

Agreement Between Magnetic Resonance Imaging Proton Density Fat Fraction Measurements and Pathologist-Assigned Steatosis Grades of Liver Biopsies From Adults With Nonalcoholic Steatohepatitis.

PubMed

Middleton, Michael S; Heba, Elhamy R; Hooker, Catherine A; Bashir, Mustafa R; Fowler, Kathryn J; Sandrasegaran, Kumar; Brunt, Elizabeth M; Kleiner, David E; Doo, Edward; Van Natta, Mark L; Lavine, Joel E; Neuschwander-Tetri, Brent A; Sanyal, Arun; Loomba, Rohit; Sirlin, Claude B

2017-09-01

We assessed the diagnostic performance of magnetic resonance imaging (MRI) proton density fat fraction (PDFF) in grading hepatic steatosis and change in hepatic steatosis in adults with nonalcoholic steatohepatitis (NASH) in a multi-center study, using central histology as reference. We collected data from 113 adults with NASH participating in a multi-center, randomized, double-masked, placebo-controlled, phase 2b trial to compare the efficacy cross-sectionally and longitudinally of obeticholic acid vs placebo. Hepatic steatosis was assessed at baseline and after 72 weeks of obeticholic acid or placebo by liver biopsy and MRI (scanners from different manufacturers, at 1.5T or 3T). We compared steatosis estimates by PDFF vs histology. Histologic steatosis grade was scored in consensus by a pathology committee. Cross-validated receiver operating characteristic (ROC) analyses were performed. At baseline, 34% of subjects had steatosis grade 0 or 1, 39% had steatosis grade 2, and 27% had steatosis grade 3; corresponding mean PDFF values were 9.8%±3.7%, 18.1%±4.3%, and 30.1%±8.1%. PDFF classified steatosis grade 0-1 vs 2-3 with an area under the ROC curve (AUROC) of 0.95 (95% CI, 0.91-0.98), and grade 0-2 vs grade 3 steatosis with an AUROC of 0.96 (95% CI, 0.93-0.99). PDFF cut-off values at 90% specificity were 16.3% for grades 2-3 and 21.7% for grade 3, with corresponding sensitivities of 83% and 84%. After 72 weeks' of obeticholic vs placebo, 42% of subjects had a reduced steatosis grade (mean reduction in PDFF from baseline of 7.4%±8.7%), 49% had no change in steatosis grade (mean increase in PDFF from baseline of 0.3%±6.3%), and 9% had an increased steatosis grade (mean increase in PDFF from baseline of 7.7%±6.0%). PDFF change identified subjects with reduced steatosis grade with an AUROC of 0.81 (95% CI, 0.71-0.91) and increased steatosis grade with an AUROC of 0.81 (95% CI, 0.63-0.99). A PDFF reduction of 5.15% identified subjects with reduced steatosis grade with 90% specificity and 58% sensitivity, whereas a PDFF increase of 5.6% identified those with increased steatosis grade with 90% specificity and 57% sensitivity. Based on data from a phase 2 randomized controlled trial of adults with NASH, PDFF estimated by MRI scanners of different field strength and at different sites, accurately classifies grades and changes in hepatic steatosis when histologic analysis of biopsies is used as a reference. Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

Consensus statement: patient safety, healthcare-associated infections and hospital environmental surfaces.

PubMed

Roques, Christine; Al Mousa, Haifaa; Duse, Adriano; Gallagher, Rose; Koburger, Torsten; Lingaas, Egil; Petrosillo, Nicola; Škrlin, Jasenka

2015-01-01

Healthcare-associated infections have serious implications for both patients and hospitals. Environmental surface contamination is the key to transmission of nosocomial pathogens. Routine manual cleaning and disinfection eliminates visible soil and reduces environmental bioburden and risk of transmission, but may not address some surface contamination. Automated area decontamination technologies achieve more consistent and pervasive disinfection than manual methods, but it is challenging to demonstrate their efficacy within a randomized trial of the multiple interventions required to reduce healthcare-associated infection rates. Until data from multicenter observational studies are available, automated area decontamination technologies should be an adjunct to manual cleaning and disinfection within a total, multi-layered system and risk-based approach designed to control environmental pathogens and promote patient safety.

[Azilsartan Medoxomil Capabilities in Arterial Hypertension and Obesity].

PubMed

Vasyuk, Y A; Shupenina, E Y; Nesvetov, V V; Nesterova, E A; Golubkova, E I

2016-12-01

Arterial hypertension (AH) is one of the most common cardiovascular disease. Angiotensin II (AT II), the hormone of renin-angiotensin-aldosterone system, realizes its negative effects through AT 1 receptors - application point of angiotensin receptor blockers (ARB). Due to different dissociation AT 1 receptors properties some ARBs are more effective than others. Multiply multicenter randomized and observational studies approve the effectiveness and safety of azilsartan medoxomil in patients with AH 1-2 grade. Several preclinical studies have shown the additional properties of azilsartan, including increase of insulin sensitivity, cardio- and nephron protection in obesity. In our clinical case we showed the positive influence of azilsartan medoxomil on clinic and ambulatory blood pressure, 24-hour aortic stiffness parameters, longitudinal left ventricular strain in patient with AH and obesity.

High-emulation mask recognition with high-resolution hyperspectral video capture system

NASA Astrophysics Data System (ADS)

Feng, Jiao; Fang, Xiaojing; Li, Shoufeng; Wang, Yongjin

2014-11-01

We present a method for distinguishing human face from high-emulation mask, which is increasingly used by criminals for activities such as stealing card numbers and passwords on ATM. Traditional facial recognition technique is difficult to detect such camouflaged criminals. In this paper, we use the high-resolution hyperspectral video capture system to detect high-emulation mask. A RGB camera is used for traditional facial recognition. A prism and a gray scale camera are used to capture spectral information of the observed face. Experiments show that mask made of silica gel has different spectral reflectance compared with the human skin. As multispectral image offers additional spectral information about physical characteristics, high-emulation mask can be easily recognized.

Interactive Videodisc Learning Systems.

ERIC Educational Resources Information Center

Currier, Richard L.

1983-01-01

Discussion of capabilities of interactive videodisc, which combines video images recorded on disc and random-access, highlights interactivity; teaching techniques with videodiscs (including masking, disassembly, movie maps, tactical maps, action code, and simulation); costs; and games. Illustrative material is provided. (High Technology, P. O. Box…

Speckle reduction in digital holography with resampling ring masks

NASA Astrophysics Data System (ADS)

Zhang, Wenhui; Cao, Liangcai; Jin, Guofan

2018-01-01

One-shot digital holographic imaging has the advantages of high stability and low temporal cost. However, the reconstruction is affected by the speckle noise. Resampling ring-mask method in spectrum domain is proposed for speckle reduction. The useful spectrum of one hologram is divided into several sub-spectra by ring masks. In the reconstruction, angular spectrum transform is applied to guarantee the calculation accuracy which has no approximation. N reconstructed amplitude images are calculated from the corresponding sub-spectra. Thanks to speckle's random distribution, superimposing these N uncorrelated amplitude images would lead to a final reconstructed image with lower speckle noise. Normalized relative standard deviation values of the reconstructed image are used to evaluate the reduction of speckle. Effect of the method on the spatial resolution of the reconstructed image is also quantitatively evaluated. Experimental and simulation results prove the feasibility and effectiveness of the proposed method.

Protecting Privacy of Shared Epidemiologic Data without Compromising Analysis Potential

DOE PAGES

Cologne, John; Grant, Eric J.; Nakashima, Eiji; ...

2012-01-01

Objective . Ensuring privacy of research subjects when epidemiologic data are shared with outside collaborators involves masking (modifying) the data, but overmasking can compromise utility (analysis potential). Methods of statistical disclosure control for protecting privacy may be impractical for individual researchers involved in small-scale collaborations. Methods . We investigated a simple approach based on measures of disclosure risk and analytical utility that are straightforward for epidemiologic researchers to derive. The method is illustrated using data from the Japanese Atomic-bomb Survivor population. Results . Masking by modest rounding did not adequately enhance security but rounding to remove several digits of relativemore » accuracy effectively reduced the risk of identification without substantially reducing utility. Grouping or adding random noise led to noticeable bias. Conclusions . When sharing epidemiologic data, it is recommended that masking be performed using rounding. Specific treatment should be determined separately in individual situations after consideration of the disclosure risks and analysis needs.« less

Protecting Privacy of Shared Epidemiologic Data without Compromising Analysis Potential

PubMed Central

Cologne, John; Grant, Eric J.; Nakashima, Eiji; Chen, Yun; Funamoto, Sachiyo; Katayama, Hiroaki

2012-01-01

Objective. Ensuring privacy of research subjects when epidemiologic data are shared with outside collaborators involves masking (modifying) the data, but overmasking can compromise utility (analysis potential). Methods of statistical disclosure control for protecting privacy may be impractical for individual researchers involved in small-scale collaborations. Methods. We investigated a simple approach based on measures of disclosure risk and analytical utility that are straightforward for epidemiologic researchers to derive. The method is illustrated using data from the Japanese Atomic-bomb Survivor population. Results. Masking by modest rounding did not adequately enhance security but rounding to remove several digits of relative accuracy effectively reduced the risk of identification without substantially reducing utility. Grouping or adding random noise led to noticeable bias. Conclusions. When sharing epidemiologic data, it is recommended that masking be performed using rounding. Specific treatment should be determined separately in individual situations after consideration of the disclosure risks and analysis needs. PMID:22505949

Optical image encryption system using nonlinear approach based on biometric authentication

NASA Astrophysics Data System (ADS)

Verma, Gaurav; Sinha, Aloka

2017-07-01

A nonlinear image encryption scheme using phase-truncated Fourier transform (PTFT) and natural logarithms is proposed in this paper. With the help of the PTFT, the input image is truncated into phase and amplitude parts at the Fourier plane. The phase-only information is kept as the secret key for the decryption, and the amplitude distribution is modulated by adding an undercover amplitude random mask in the encryption process. Furthermore, the encrypted data is kept hidden inside the face biometric-based phase mask key using the base changing rule of logarithms for secure transmission. This phase mask is generated through principal component analysis. Numerical experiments show the feasibility and the validity of the proposed nonlinear scheme. The performance of the proposed scheme has been studied against the brute force attacks and the amplitude-phase retrieval attack. Simulation results are presented to illustrate the enhanced system performance with desired advantages in comparison to the linear cryptosystem.

Protecting privacy of shared epidemiologic data without compromising analysis potential.

PubMed

Cologne, John; Grant, Eric J; Nakashima, Eiji; Chen, Yun; Funamoto, Sachiyo; Katayama, Hiroaki

2012-01-01

Ensuring privacy of research subjects when epidemiologic data are shared with outside collaborators involves masking (modifying) the data, but overmasking can compromise utility (analysis potential). Methods of statistical disclosure control for protecting privacy may be impractical for individual researchers involved in small-scale collaborations. We investigated a simple approach based on measures of disclosure risk and analytical utility that are straightforward for epidemiologic researchers to derive. The method is illustrated using data from the Japanese Atomic-bomb Survivor population. Masking by modest rounding did not adequately enhance security but rounding to remove several digits of relative accuracy effectively reduced the risk of identification without substantially reducing utility. Grouping or adding random noise led to noticeable bias. When sharing epidemiologic data, it is recommended that masking be performed using rounding. Specific treatment should be determined separately in individual situations after consideration of the disclosure risks and analysis needs.

The performances of standard and ResMed masks during bag-valve-mask ventilation.

PubMed

Lee, Hyoung Youn; Jeung, Kyung Woon; Lee, Byung Kook; Lee, Seung Joon; Jung, Yong Hun; Lee, Geo Sung; Min, Yong Il; Heo, Tag

2013-01-01

A tight mask seal is frequently difficult to obtain and maintain during single-rescuer bag-valve-mask (BVM) ventilation. The ResMed mask (Bella Vista, NSW, Australia) is a continuous-positive-airway-pressure mask (CM) designed for noninvasive ventilation. In this study, we compared the ventilation performances of a standard mask (SM) and a ResMed CM using a simulation manikin in an out-of-hospital single-rescuer BVM ventilation scenario. Thirty emergency medical technicians (EMTs) performed two 2-minute attempts to ventilate a simulation manikin using BVM ventilation, alternatively, with the SM or the ResMed CM in a randomized order. Ventilation parameters including tidal volume and peak airway pressure were measured using computer analysis software connected to the simulation manikin. Successful volume delivery was defined as delivery of 440-540 mL of tidal volume in accord with present cardiopulmonary resuscitation guidelines. BVM ventilation using the ResMed CM produced higher mean (± standard deviation) tidal volumes (452 ± 50 mL vs. 394 ± 113 mL, p = 0.014) and had a higher proportion of successful volume deliveries (65.3% vs. 26.7%, p < 0.001) than that using the SM. Peak airway pressure was higher in BVM ventilation using the ResMed CM (p = 0.035). Stomach insufflation did not occur during either method. Twenty-nine of the participants (96.7%) preferred BVM ventilation using the ResMed CM. BVM ventilations using ResMed CM resulted in a significantly higher proportion of successful volume deliveries meeting the currently recommended range of tidal volume. Clinical studies are needed to determine the value of the ResMed CM for BVM ventilation.

Comparison of binary mask defect printability analysis using virtual stepper system and aerial image microscope system

NASA Astrophysics Data System (ADS)

Phan, Khoi A.; Spence, Chris A.; Dakshina-Murthy, S.; Bala, Vidya; Williams, Alvina M.; Strener, Steve; Eandi, Richard D.; Li, Junling; Karklin, Linard

1999-12-01

As advanced process technologies in the wafer fabs push the patterning processes toward lower k1 factor for sub-wavelength resolution printing, reticles are required to use optical proximity correction (OPC) and phase-shifted mask (PSM) for resolution enhancement. For OPC/PSM mask technology, defect printability is one of the major concerns. Current reticle inspection tools available on the market sometimes are not capable of consistently differentiating between an OPC feature and a true random defect. Due to the process complexity and high cost associated with the making of OPC/PSM reticles, it is important for both mask shops and lithography engineers to understand the impact of different defect types and sizes to the printability. Aerial Image Measurement System (AIMS) has been used in the mask shops for a number of years for reticle applications such as aerial image simulation and transmission measurement of repaired defects. The Virtual Stepper System (VSS) provides an alternative method to do defect printability simulation and analysis using reticle images captured by an optical inspection or review system. In this paper, pre- programmed defects and repairs from a Defect Sensitivity Monitor (DSM) reticle with 200 nm minimum features (at 1x) will be studied for printability. The simulated resist lines by AIMS and VSS are both compared to SEM images of resist wafers qualitatively and quantitatively using CD verification.Process window comparison between unrepaired and repaired defects for both good and bad repair cases will be shown. The effect of mask repairs to resist pattern images for the binary mask case will be discussed. AIMS simulation was done at the International Sematech, Virtual stepper simulation at Zygo and resist wafers were processed at AMD-Submicron Development Center using a DUV lithographic process for 0.18 micrometer Logic process technology.

CONCEPTT: Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial: A multi-center, multi-national, randomized controlled trial - Study protocol.

PubMed

Feig, Denice S; Asztalos, Elizabeth; Corcoy, Rosa; De Leiva, Alberto; Donovan, Lois; Hod, Moshe; Jovanovic, Lois; Keely, Erin; Kollman, Craig; McManus, Ruth; Murphy, Kellie; Ruedy, Katrina; Sanchez, J Johanna; Tomlinson, George; Murphy, Helen R

2016-07-18

Women with type 1 diabetes strive for optimal glycemic control before and during pregnancy to avoid adverse obstetric and perinatal outcomes. For most women, optimal glycemic control is challenging to achieve and maintain. The aim of this study is to determine whether the use of real-time continuous glucose monitoring (RT-CGM) will improve glycemic control in women with type 1 diabetes who are pregnant or planning pregnancy. A multi-center, open label, randomized, controlled trial of women with type 1 diabetes who are either planning pregnancy with an HbA1c of 7.0 % to ≤10.0 % (53 to ≤ 86 mmol/mol) or are in early pregnancy (<13 weeks 6 days) with an HbA1c of 6.5 % to ≤10.0 % (48 to ≤ 86 mmol/mol). Participants will be randomized to either RT-CGM alongside conventional intermittent home glucose monitoring (HGM), or HGM alone. Eligible women will wear a CGM which does not display the glucose result for 6 days during the run-in phase. To be eligible for randomization, a minimum of 4 HGM measurements per day and a minimum of 96 hours total with 24 hours overnight (11 pm-7 am) of CGM glucose values are required. Those meeting these criteria are randomized to RT- CGM or HGM. A total of 324 women will be recruited (110 planning pregnancy, 214 pregnant). This takes into account 15 and 20 % attrition rates for the planning pregnancy and pregnant cohorts and will detect a clinically relevant 0.5 % difference between groups at 90 % power with 5 % significance. Randomization will stratify for type of insulin treatment (pump or multiple daily injections) and baseline HbA1c. Analyses will be performed according to intention to treat. The primary outcome is the change in glycemic control as measured by HbA1c from baseline to 24 weeks or conception in women planning pregnancy, and from baseline to 34 weeks gestation during pregnancy. Secondary outcomes include maternal hypoglycemia, CGM time in, above and below target (3.5-7.8 mmol/l), glucose variability measures, maternal and neonatal outcomes. This will be the first international multicenter randomized controlled trial to evaluate the impact of RT- CGM before and during pregnancy in women with type 1 diabetes. ClinicalTrials.gov Identifier: NCT01788527 Registration Date: December 19, 2012.

Retinopathy and chronic kidney disease in the Chronic Renal Insufficiency Cohort (CRIC) study.

PubMed

Grunwald, Juan E; Alexander, Judith; Ying, Gui-Shuang; Maguire, Maureen; Daniel, Ebenezer; Whittock-Martin, Revell; Parker, Candace; McWilliams, Kathleen; Lo, Joan C; Go, Alan; Townsend, Raymond; Gadegbeku, Crystal A; Lash, James P; Fink, Jeffrey C; Rahman, Mahboob; Feldman, Harold; Kusek, John W; Xie, Dawei; Jaar, Bernard G

2012-09-01

To investigate the association between retinopathy and chronic kidney disease. In this observational, cross-sectional study, 2605 patients of the Chronic Renal Insufficiency Cohort (CRIC) study, a multicenter study of chronic kidney disease, were offered participation. Nonmydriatic fundus photographs of the disc and macula in both eyes were obtained in 1936 of these subjects. The photographs were reviewed in a masked fashion at a central photograph reading center using standard protocols. Presence and severity of retinopathy (diabetic, hypertensive, or other) and vessel diameter caliber were assessed by trained graders and a retinal specialist using protocols developed for large epidemiologic studies. Kidney function measurements and information on traditional and nontraditional risk factors for decreased kidney function were obtained from the CRIC study. Greater severity of retinopathy was associated with lower estimated glomerular filtration rate after adjustment for traditional and nontraditional risk factors. The presence of vascular abnormalities usually associated with hypertension was also associated with lower estimated glomerular filtration rate. We found no strong direct relationship between estimated glomerular filtration rate and average arteriolar or venular calibers. Our findings show a strong association between severity of retinopathy and its features and level of kidney function after adjustment for traditional and nontraditional risk factors for chronic kidney disease, suggesting that retinovascular pathology reflects renal disease.

Socio-demographic and clinical profiles of paranoid and nonparanoid schizophrenia: a prospective, multicenter study in China.

PubMed

Xiang, Yu-Tao; Wang, Chuan-Yue; Chiu, Helen F K; Weng, Yong-Zhen; Bo, Qi-Jing; Chan, Sandra S M; Lee, Edwin H M; Ungvari, Gabor S

2011-07-01

This study aimed to explore the socio-demographic and clinical characteristics of paranoid and nonparanoid subtypes of schizophrenia. In a multicenter, randomized, controlled, longitudinal study, 374 clinically stable schizophrenia patients were interviewed at entry with standardized assessment instruments and followed for 12-26 months. In the multivariate analysis, male sex, married marital status, urban abode, and more frequent relapse over the study period were independently associated with paranoid schizophrenia. The socio-demographic and clinical characteristics of Chinese patients with the paranoid subtype of schizophrenia are different from those of their Caucasian counterparts who are more likely to be women and have a better outcome. © 2010 Wiley Periodicals, Inc.

Pupil dilation using a pledget sponge: a randomized controlled trial.

PubMed

McCormick, Austin; Srinivasan, Sathish; Harun, Shabbir; Watts, Mark

2006-08-01

To show that a pledget soaked in mydriatics and placed in the lower conjunctival fornix is as effective as drops in providing mydriasis for cataract surgery. A randomized, masked, controlled trial of 56 patients assigned to either a pledget group (n=25) or a control eye drops group (n=31) was carried out. Controls had the routine practice of repeated topical mydriatic drops: tropicamide, phenylepherine and atropine. The trial group had a 3-mm pledget trimmed, soaked in mydriatics and placed in the inferior fornix for 20 min. Pupil diameter was measured using a photographic technique with a standard scale shown in each picture. Two masked observers measured the pupils using the scale of the ruler in the developed photograph. All patients completed a 0-10 stinging score prior to surgery. There were no complications. The mean pupil diameter in the control group was 7.23 (6.91-7.94 95% confidence intervals [CI]) and 7.44 (6.96-7.92 95% CI) in the pledget group. There was no statistically significant difference in pupil diameter between the two groups: difference between means 0.21 (-0.32 to 0.75 95% CI) and Student's t-test of the difference between means (t=0.8 and two-tailed) probability P=0.43. There was no significant difference in the stinging scores: Mann-Whitney test P=0.69. The use of a pledget cellulose sponge to deliver mydriatics prior to cataract surgery is as effective as the conventional method of repeated drop administration and was not associated with any adverse effects.

Chinese herbal Pulian ointment in treating psoriasis vulgaris of blood-heat syndrome: a multi-center, double-blind, randomized, placebo-controlled trial.

PubMed

Li, Nuo; Zhao, Wenbin; Xing, Jianmin; Liu, Jianping; Zhang, Guangzhong; Zhang, Yunbi; Li, Yuanwen; Liu, Wali; Shi, Fei; Bai, Yanping

2017-05-15

Traditional Chinese medicine (TCM) has a long history in the treatment of psoriasis vulgaris. We aimed to evaluate the clinical efficacy and safety of Chinese herbal Pulian ointment in treating psoriasis vulgaris of blood-heat syndrome. A multicenter, randomized, double-blind, placebo-controlled trial was conducted. Participants with psoriasis vulgaris of blood-heat syndrome were blinded and randomized to receive Pulian ointment or placebo ointment twice daily for 4 weeks, with follow-up 8 weeks after treatment. Psoriasis Area Severity Index (PASI) scores, severity of each symptom and area of skin lesion and quality of life were assessed at baseline, 2 weeks, and 4 weeks. Adverse events were recorded during the study. SAS 9.4 software and SPSS 17.0 software was applied for data analysis. A total of 300 participants with psoriasis vulgaris of blood-heat syndrome were assessed for eligibility, and 294 were randomly assigned to the Pulian ointment and placebo group from six study centers. Full analysis set (FAS): after 4 weeks of treatment, there were significant differences between groups in PASI score and the separate score of skin lesion area, favoring Pulian ointment group (P < 0.05). However, no significant differences were observed in scores of scaling, erythema and induration/thickness (P > 0.05). Per protocol set (PPS): There was no statistically significant difference in PASI score and separate score of each symptom and area of skin lesion between two groups (P > 0.05). Quality of life measured by Hamilton Anxiety Rating Scale (HAMA) and 36-Item Short Form Health Survey (SF-36) improved after treatment in both groups, but there was no significant difference between the two groups (P > 0.05). After being followed up for 8 weeks, the total relapse rates of the Pulian Ointment group and placebo group were 5.88 and 8.45%, respectively, and the difference was not statistically significant between the two groups (P > 0.05). No adverse event was observed in both groups throughout the study. Pulian Ointment seems effective and well tolerated in improving the PASI score and separate score of skin lesion area for patients with psoriasis vulgaris of blood-heat syndrome. Further research could build on the current study to explore whether other preparation forms and greater intervention intensity are necessary for better therapeutic effects. Chictr.org.cn Identifier ChiCTR-TRC-12002054 .

Cardiac biomarkers in youth with type 2 diabetes mellitus: Results from the Today Study

USDA-ARS?s Scientific Manuscript database

To examine cardiac biomarkers over time in youth-onset type 2 diabetes, and relate serum concentrations to cardiovascular disease risk factors, and left ventricular structure and function. TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) was a multicenter randomized trial of 3 ...

Efficacy of chlorhexidine varnish for the prevention of adult caries: a randomized trial.

PubMed

Papas, A S; Vollmer, W M; Gullion, C M; Bader, J; Laws, R; Fellows, J; Hollis, J F; Maupomé, G; Singh, M L; Snyder, J; Blanchard, P

2012-02-01

The Prevention of Adult Caries Study, an NIDCR-funded multicenter, double-blind, randomized clinical trial, enrolled 983 adults (aged 18-80 yrs) at high risk for developing caries (20 or more intact teeth and 2 or more lesions at screening) to test the efficacy of a chlorhexidine diacetate 10% weight per volume (w/v) dental coating (CHX). We excluded participants for whom the study treatment was contraindicated or whose health might affect outcomes or ability to complete the study. Participants were randomly assigned to receive either the CHX coating (n = 490) or a placebo control (n = 493). Coatings were applied weekly for 4 weeks and a fifth time 6 months later. The primary outcome (total net D(1-2)FS increment) was the sum of weighted counts of changes in tooth surface status over 13 months. We observed no significant difference between the two treatment arms in either the intention-to-treat or per-protocol analyses. Analysis of 3 protocol-specified secondary outcomes produced similar findings. This trial failed to find that 10% (w/v) chlorhexidine diacetate coating was superior to placebo coating for the prevention of new caries (Clinicaltrials.gov registration number NCT00357877).

Are mammographic changes in the tumor bed more pronounced after intraoperative radiotherapy for breast cancer? Subgroup analysis from a randomized trial (TARGIT-A).

PubMed

Engel, Dorothee; Schnitzer, Andreas; Brade, Joachim; Blank, Elena; Wenz, Frederik; Suetterlin, Marc; Schoenberg, Stefan; Wasser, Klaus

2013-01-01

Intraoperative radiotherapy (IORT) with low-energy x-rays is increasingly used in breast-conserving therapy (BCT). Previous non-randomized studies have observed mammographic changes in the tumor bed to be more pronounced after IORT. The purpose of this study was to reassess the postoperative changes in a randomized single-center subgroup of patients from a multicenter trial (TARGIT-A). In this subgroup (n = 48) 27 patients received BCT with IORT, 21 patients had BCT with standard whole-breast radiotherapy serving as controls. Overall 258 postoperative mammograms (median follow-up 4.3 years, range 3-8) were retrospectively evaluated by two radiologists in consensus focusing on changes in the tumor bed. Fat necroses showed to be significantly more frequent (56% versus 24%) and larger (8.7 versus 1.6 sq cm, median) after IORT than those in controls. Scar calcifications were also significantly more frequent after IORT (63% versus 19%). The high incidence of large fat necroses in our study confirms previous study findings. However, the overall higher incidence of calcifications in the tumor bed after IORT represents a new finding, requiring further attention. © 2012 Wiley Periodicals, Inc.

Measuring the Effects of an Animal-Assisted Intervention for Pediatric Oncology Patients and Their Parents: A Multisite Randomized Controlled Trial [Formula: see text].

PubMed

McCullough, Amy; Ruehrdanz, Ashleigh; Jenkins, Molly A; Gilmer, Mary Jo; Olson, Janice; Pawar, Anjali; Holley, Leslie; Sierra-Rivera, Shirley; Linder, Deborah E; Pichette, Danielle; Grossman, Neil J; Hellman, Cynthia; Guérin, Noémi A; O'Haire, Marguerite E

2018-05-01

This multicenter, parallel-group, randomized trial examined the effects of an animal-assisted intervention on the stress, anxiety, and health-related quality of life for children diagnosed with cancer and their parents. Newly diagnosed patients, aged 3 to 17 years (n = 106), were randomized to receive either standard care plus regular visits from a therapy dog (intervention group), or standard care only (control group). Data were collected at set points over 4 months of the child's treatment. Measures included the State-Trait Anxiety Inventory™, Pediatric Quality of Life Inventory, Pediatric Inventory for Parents, and child blood pressure and heart rate. All instruments were completed by the child and/or his/her parent(s). Children in both groups experienced a significant reduction in state anxiety ( P < .001). Parents in the intervention group showed significantly decreased parenting stress ( P = .008), with no changes in stress among parents in the control group. However, no significant differences between groups over time on any measures were observed. Animal-assisted interventions may provide certain benefits for parents and families during the initial stages of pediatric cancer treatment.

The impact of privacy protections on recruitment in a multicenter stroke genetics study

PubMed Central

Chen, D.T.; Worrall, B.B.; Brown, R.D.; Brott, T.G.; Kissela, B.M.; Olson, T.S.; Rich, S.S.; Meschia, J.F.

2006-01-01

The authors reviewed the recruitment of stroke-affected sibling pairs using a letter-based, proband-initiated contact strategy. The authors randomly sampled 99 proband enrollment forms (Phase 1) and randomly sampled 50 sibling reply cards (Phase 2). The sibling response rate was 30.6%, for a pedigree response rate of 58%. Of the siblings who replied, 96% authorized further contact. Median time from proband enrollment to pedigree DNA banking, which required 3+ probands, was 134 days. PMID:15728301

Moving stimuli are less effectively masked using traditional continuous flash suppression (CFS) compared to a moving Mondrian mask (MMM): a test case for feature-selective suppression and retinotopic adaptation.

PubMed

Moors, Pieter; Wagemans, Johan; de-Wit, Lee

2014-01-01

Continuous flash suppression (CFS) is a powerful interocular suppression technique, which is often described as an effective means to reliably suppress stimuli from visual awareness. Suppression through CFS has been assumed to depend upon a reduction in (retinotopically specific) neural adaptation caused by the continual updating of the contents of the visual input to one eye. In this study, we started from the observation that suppressing a moving stimulus through CFS appeared to be more effective when using a mask that was actually more prone to retinotopically specific neural adaptation, but in which the properties of the mask were more similar to those of the to-be-suppressed stimulus. In two experiments, we find that using a moving Mondrian mask (i.e., one that includes motion) is more effective in suppressing a moving stimulus than a regular CFS mask. The observed pattern of results cannot be explained by a simple simulation that computes the degree of retinotopically specific neural adaptation over time, suggesting that this kind of neural adaptation does not play a large role in predicting the differences between conditions in this context. We also find some evidence consistent with the idea that the most effective CFS mask is the one that matches the properties (speed) of the suppressed stimulus. These results question the general importance of retinotopically specific neural adaptation in CFS, and potentially help to explain an implicit trend in the literature to adapt one's CFS mask to match one's to-be-suppressed stimuli. Finally, the results should help to guide the methodological development of future research where continuous suppression of moving stimuli is desired.

Nanotip Carpets as Antireflection Surfaces

NASA Technical Reports Server (NTRS)

Bae, Youngsam; Mobasser, Sohrab; Manohara, Harish; Lee, Choonsup

2008-01-01

Carpet-like random arrays of metal-coated silicon nanotips have been shown to be effective as antireflection surfaces. Now undergoing development for incorporation into Sun sensors that would provide guidance for robotic exploratory vehicles on Mars, nanotip carpets of this type could also have many uses on Earth as antireflection surfaces in instruments that handle or detect ultraviolet, visible, or infrared light. In the original Sun-sensor application, what is required is an array of 50-micron-diameter apertures on what is otherwise an opaque, minimally reflective surface, as needed to implement a miniature multiple-pinhole camera. The process for fabrication of an antireflection nanotip carpet for this application (see Figure 1) includes, and goes somewhat beyond, the process described in A New Process for Fabricating Random Silicon Nanotips (NPO-40123), NASA Tech Briefs, Vol. 28, No. 1 (November 2004), page 62. In the first step, which is not part of the previously reported process, photolithography is performed to deposit etch masks to define the 50-micron apertures on a silicon substrate. In the second step, which is part of the previously reported process, the non-masked silicon area between the apertures is subjected to reactive ion etching (RIE) under a special combination of conditions that results in the growth of fluorine-based compounds in randomly distributed formations, known in the art as "polymer RIE grass," that have dimensions of the order of microns. The polymer RIE grass formations serve as microscopic etch masks during the next step, in which deep reactive ion etching (DRIE) is performed. What remains after DRIE is the carpet of nano - tips, which are high-aspect-ratio peaks, the tips of which have radii of the order of nanometers. Next, the nanotip array is evaporatively coated with Cr/Au to enhance the absorption of light (more specifically, infrared light in the Sun-sensor application). The photoresist etch masks protecting the apertures are then removed by dipping the substrate into acetone. Finally, for the Sun-sensor application, the back surface of the substrate is coated with a 57-nm-thick layer of Cr for attenuation of sunlight.

Identifying and collecting pertinent medical records for centralized abstraction in a multi-center randomized clinical trial: the model used by the American College of Radiology arm of the National Lung Screening Trial.

PubMed

Gareen, Ilana F; Sicks, JoRean D; Jain, Amanda Adams; Moline, Denise; Coffman-Kadish, Nancy

2013-01-01

In clinical trials and epidemiologic studies, information on medical care utilization and health outcomes is often obtained from medical records. For multi-center studies, this information may be gathered by personnel at individual sites or by staff at a central coordinating center. We describe the process used to develop a HIPAA-compliant centralized process to collect medical record information for a large multi-center cancer screening trial. The framework used to select, request, and track medical records incorporated a participant questionnaire with unique identifiers for each medical provider. De-identified information from the questionnaires was sent to the coordinating center indexed by these identifiers. The central coordinating center selected specific medical providers for abstraction and notified sites using these identifiers. The site personnel then linked the identifiers with medical provider information. Staff at the sites collected medical records and provided them for central abstraction. Medical records were successfully obtained and abstracted to ascertain information on outcomes and health care utilization in a study with over 18,000 study participants. Collection of records required for outcomes related to positive screening examinations and lung cancer diagnosis exceeded 90%. Collection of records for all aims was 87.32%. We designed a successful centralized medical record abstraction process that may be generalized to other research settings, including observational studies. The coordinating center received no identifying data. The process satisfied requirements imposed by the Health Insurance Portability and Accountability Act and concerns of site institutional review boards with respect to protected health information. Copyright © 2012 Elsevier Inc. All rights reserved.

Identifying and collecting pertinent medical records for centralized abstraction in a multi-center randomized clinical trial: The model used by the American College of Radiology arm of the National Lung Screening Trial

PubMed Central

Gareen, Ilana F.; Sicks, JoRean; Adams, Amanda; Moline, Denise; Coffman-Kadish, Nancy

2012-01-01

Background In clinical trials and epidemiologic studies, information on medical care utilization and health outcomes is often obtained from medical records. For multi-center studies, this information may be gathered by personnel at individual sites or by staff at a central coordinating center. We describe the process used to develop a HIPAA-compliant centralized process to collect medical record information for a large multi-center cancer screening trial. Methods The framework used to select, request, and track medical records incorporated a participant questionnaire with unique identifiers for each medical provider. De-identified information from the questionnaires was sent to the coordinating center indexed by these identifiers. The central coordinating center selected specific medical providers for abstraction and notified sites using these identifiers. The site personnel then linked the identifiers with medical provider information. Staff at the sites collected medical records and provided them for central abstraction. Results Medical records were successfully obtained and abstracted to ascertain information on outcomes and health care utilization in a study with over 18,000 study participants. Collection of records required for outcomes related to positive screening examinations and lung cancer diagnosis exceeded 90%. Collection of records for all aims was 87.32%. Conclusions We designed a successful centralized medical record abstraction process that may be generalized to other research settings, including observational studies. The coordinating center received no identifying data. The process satisfied requirements imposed by the Health Insurance Portability and Accountability Act and concerns of site institutional review boards with respect to protected health information. PMID:22982342

Clinical outcomes of atherectomy prior to percutaneous coronary intervention: A comparison of outcomes following rotational versus orbital atherectomy (COAP-PCI study).

PubMed

Meraj, Perwaiz M; Shlofmitz, Evan; Kaplan, Barry; Jauhar, Rajiv; Doshi, Rajkumar

2018-04-29

Because of the challenges in treating calcified coronary artery disease (CAD), lesion preparation has become increasingly important prior to percutaneous coronary intervention (PCI). Despite growing data for both rotational atherectomy (RA) and orbital atherectomy (OA), there have been no multicenter studies comparing the safety and efficacy of both. We sought to examine the clinical outcomes of patients with calcified CAD who underwent atherectomy. A total of 39 870 patients from five tertiary care hospitals who had PCI from January 2011 to January 2017 were identified. 907 patients who had RA or OA were included. This multicenter, prospectively collected observational analysis compared OA and RA. The primary end-point was myocardial infarction and safety outcomes including significant dissection, perforation, cardiac tamponade, and vascular complications. Propensity score matching (1:1) was performed to reduce selection bias. After matching, 546 patients were included in the final analysis. The primary endpoint, myocardial infarction occurred less frequently with OA compared to RA (6.7% vs 13.8%, P ≤ 0.01) in propensity score matched cohorts. Procedural safety outcomes were comparable between the groups. The secondary outcome of death on discharge occurred less in the OA group as compared with RA (0% vs 2.2%, P = 0.01). Fluoroscopy time was less in patients who were treated with OA (21.9 vs 25.6 min, P ≤ 0.01). Additional secondary outcomes were comparable between groups. In this non-randomized, multicenter comparison of contemporary atherectomy devices, OA was associated with significantly decreased in-hospital myocardial infarction and mortality after propensity score matching with decreased fluoroscopy time. © 2018, Wiley Periodicals, Inc.

Impact of study oximeter masking algorithm on titration of oxygen therapy in the Canadian oxygen trial.

PubMed

Schmidt, Barbara; Roberts, Robin S; Whyte, Robin K; Asztalos, Elizabeth V; Poets, Christian; Rabi, Yacov; Solimano, Alfonso; Nelson, Harvey

2014-10-01

To compare oxygen saturations as displayed to caregivers on offset pulse oximeters in the 2 groups of the Canadian Oxygen Trial. In 5 double-blind randomized trials of oxygen saturation targeting, displayed saturations between 88% and 92% were offset by 3% above or below the true values but returned to true values below 84% and above 96%. During the transition, displayed values remained static at 96% in the lower and at 84% in the higher target group during a 3% change in true saturations. In contrast, displayed values changed rapidly from 88% to 84% in the lower and from 92% to 96% in the higher target group during a 1% change in true saturations. We plotted the distributions of median displayed saturations on days with >12 hours of supplemental oxygen in 1075 Canadian Oxygen Trial participants to reconstruct what caregivers observed at the bedside. The oximeter masking algorithm was associated with an increase in both stability and instability of displayed saturations that occurred during the transition between offset and true displayed values at opposite ends of the 2 target ranges. Caregivers maintained saturations at lower displayed values in the higher than in the lower target group. This differential management reduced the separation between the median true saturations in the 2 groups by approximately 3.5%. The design of the oximeter masking algorithm may have contributed to the smaller-than-expected separation between true saturations in the 2 study groups of recent saturation targeting trials in extremely preterm infants. Copyright © 2014 Elsevier Inc. All rights reserved.

Short-term Forecasting of the Prevalence of Trachoma: Expert Opinion, Statistical Regression, versus Transmission Models

PubMed Central

Liu, Fengchen; Porco, Travis C.; Amza, Abdou; Kadri, Boubacar; Nassirou, Baido; West, Sheila K.; Bailey, Robin L.; Keenan, Jeremy D.; Solomon, Anthony W.; Emerson, Paul M.; Gambhir, Manoj; Lietman, Thomas M.

2015-01-01

Background Trachoma programs rely on guidelines made in large part using expert opinion of what will happen with and without intervention. Large community-randomized trials offer an opportunity to actually compare forecasting methods in a masked fashion. Methods The Program for the Rapid Elimination of Trachoma trials estimated longitudinal prevalence of ocular chlamydial infection from 24 communities treated annually with mass azithromycin. Given antibiotic coverage and biannual assessments from baseline through 30 months, forecasts of the prevalence of infection in each of the 24 communities at 36 months were made by three methods: the sum of 15 experts’ opinion, statistical regression of the square-root-transformed prevalence, and a stochastic hidden Markov model of infection transmission (Susceptible-Infectious-Susceptible, or SIS model). All forecasters were masked to the 36-month results and to the other forecasts. Forecasts of the 24 communities were scored by the likelihood of the observed results and compared using Wilcoxon’s signed-rank statistic. Findings Regression and SIS hidden Markov models had significantly better likelihood than community expert opinion (p = 0.004 and p = 0.01, respectively). All forecasts scored better when perturbed to decrease Fisher’s information. Each individual expert’s forecast was poorer than the sum of experts. Interpretation Regression and SIS models performed significantly better than expert opinion, although all forecasts were overly confident. Further model refinements may score better, although would need to be tested and compared in new masked studies. Construction of guidelines that rely on forecasting future prevalence could consider use of mathematical and statistical models. PMID:26302380

Short-term Forecasting of the Prevalence of Trachoma: Expert Opinion, Statistical Regression, versus Transmission Models.

PubMed

Liu, Fengchen; Porco, Travis C; Amza, Abdou; Kadri, Boubacar; Nassirou, Baido; West, Sheila K; Bailey, Robin L; Keenan, Jeremy D; Solomon, Anthony W; Emerson, Paul M; Gambhir, Manoj; Lietman, Thomas M

2015-08-01

Trachoma programs rely on guidelines made in large part using expert opinion of what will happen with and without intervention. Large community-randomized trials offer an opportunity to actually compare forecasting methods in a masked fashion. The Program for the Rapid Elimination of Trachoma trials estimated longitudinal prevalence of ocular chlamydial infection from 24 communities treated annually with mass azithromycin. Given antibiotic coverage and biannual assessments from baseline through 30 months, forecasts of the prevalence of infection in each of the 24 communities at 36 months were made by three methods: the sum of 15 experts' opinion, statistical regression of the square-root-transformed prevalence, and a stochastic hidden Markov model of infection transmission (Susceptible-Infectious-Susceptible, or SIS model). All forecasters were masked to the 36-month results and to the other forecasts. Forecasts of the 24 communities were scored by the likelihood of the observed results and compared using Wilcoxon's signed-rank statistic. Regression and SIS hidden Markov models had significantly better likelihood than community expert opinion (p = 0.004 and p = 0.01, respectively). All forecasts scored better when perturbed to decrease Fisher's information. Each individual expert's forecast was poorer than the sum of experts. Regression and SIS models performed significantly better than expert opinion, although all forecasts were overly confident. Further model refinements may score better, although would need to be tested and compared in new masked studies. Construction of guidelines that rely on forecasting future prevalence could consider use of mathematical and statistical models. Clinicaltrials.gov NCT00792922.

Effect of Masking on Subjective Responses to Daily Disposable Contact Lenses.

PubMed

Keir, Nancy; Luensmann, Doerte; Woods, Craig A; Bergenske, Peter; Fahmy, Mary; Fonn, Desmond

2016-08-01

To explore the effect of masking on subjective responses when wearing daily disposable (DD) contact lenses. In an adaptation phase, habitual wearers of Manufacturer-A (MFA) (n = 43) and Manufacturer-B (MFB) (n = 53) wore MFA-brand 1 or MFB-brand 1 DDs, respectively, for 30 days, open-label. Subjects were then randomly assigned to one of two experiments. Each experiment included two, 3-day crossover phases. An enhanced version of MFA and MFB lenses (MFA-brand 2 and MFB-brand 2) were worn contralaterally to evaluate potential differences in masking result between manufacturers. Experiment 1: subjects were fully masked to lens and packaging (FM) then unmasked (UM). Experiment 2: subjects were FM then partially masked using an over-label (PM). Comfort ratings (0-100) were recorded for each lens daily and preference between lenses was recorded on day 3 for each crossover phase. The mean difference between 0-100 ratings or preference when FM or PM versus UM for the same lens was considered a measurement of the effect associated with masking. The purpose of the study was withheld from subjects to minimize bias. The effect associated with masking for habitual wearers of MFA and MFB lenses was less than 1 out of 100 (0 ± 2.5) in both experiments. Fifty-eight subjects (60%) expressed no preference when FM. This decreased to 29 (30%) when UM or PM (proportion test, p < 0.001). Approximately half the subjects had a change in lens preference when they were UM or PM, primarily in favor of their habitual lens manufacturer. Masking did not have a measurable impact on 0-100 ratings with the DD lenses used in this study but did have an impact on lens preference. Subjects were more likely to express a preference when they handled the lenses and were exposed to the lens packaging and, in some cases, able to read the lens brand and lens manufacturer.

Small incision lenticule extraction (SMILE) versus laser in-situ keratomileusis (LASIK): study protocol for a randomized, non-inferiority trial.

PubMed

Ang, Marcus; Tan, Donald; Mehta, Jodhbir S

2012-05-31

Small incision lenticule extraction or SMILE is a novel form of 'flapless' corneal refractive surgery that was adapted from refractive lenticule extraction (ReLEx). SMILE uses only one femtosecond laser to complete the refractive surgery, potentially reducing surgical time, side effects, and cost. If successful, SMILE could potentially replace the current, widely practiced laser in-situ keratomileusis or LASIK. The aim of this study is to evaluate whether SMILE is non-inferior to LASIK in terms of refractive outcomes at 3 months post-operatively. Single tertiary center, parallel group, single-masked, paired-eye design, non-inferiority, randomized controlled trial. Participants who are eligible for LASIK will be enrolled for study after informed consent. Each participant will be randomized to receive SMILE and LASIK in each eye. Our primary hypothesis (stated as null) in this non-inferiority trial would be that SMILE differs from LASIK in adults (>21 years old) with myopia (> -3.00 diopter (D)) at a tertiary eye center in terms of refractive predictability at 3 months post-operatively. Our secondary hypothesis (stated as null) in this non-inferiority trial would be that SMILE differs from LASIK in adults (>21 years old) with myopia (> -3.00 D) at a tertiary eye center in terms of other refractive outcomes (efficacy, safety, higher-order aberrations) at 3 months post-operatively. Our primary outcome is refractive predictability, which is one of several standard refractive outcomes, defined as the proportion of eyes achieving a postoperative spherical equivalent (SE) within ±0.50 D of the intended target. Randomization will be performed using random allocation sequence generated by a computer with no blocks or restrictions, and implemented by concealing the number-coded surgery within sealed envelopes until just before the procedure. In this single-masked trial, subjects and their caregivers will be masked to the assigned treatment in each eye. This novel trial will provide information on whether SMILE has comparable, if not superior, refractive outcomes compared to the established LASIK for myopia, thus providing evidence for translation into clinical practice. Clinicaltrials.gov NCT01216475.

Coherent pulse position modulation quantum cipher

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

Sohma, Masaki; Hirota, Osamu

2014-12-04

On the basis of fundamental idea of Yuen, we present a new type of quantum random cipher, where pulse position modulated signals are encrypted in the picture of quantum Gaussian wave form. We discuss the security of our proposed system with a phase mask encryption.

White fish reduces cardiovascular risk factors in patients with metabolic syndrome: the WISH-CARE study, a multicenter randomized clinical trial.

PubMed

Vázquez, C; Botella-Carretero, J I; Corella, D; Fiol, M; Lage, M; Lurbe, E; Richart, C; Fernández-Real, J M; Fuentes, F; Ordóñez, A; de Cos, A I; Salas-Salvadó, J; Burguera, B; Estruch, R; Ros, E; Pastor, O; Casanueva, F F

2014-03-01

Reduction of cardiovascular risk with high consumption of fish in diet is still a matter of debate, and concerns about heavy metal contamination have limited consumption of oily fish. We aimed to evaluate the effect of regular ingestion of white fish on cardiovascular risk factors in patients with metabolic syndrome. Multicenter randomized crossover clinical trial including 273 individuals with metabolic syndrome. An 8-week only-one dietary intervention: 100 g/d of white fish (Namibia hake) with advice on a healthy diet, compared with no fish or seafood with advice on a healthy diet. Outcomes were lipid profile, individual components of the metabolic syndrome, serum insulin concentrations, homeostasis model of insulin resistance, serum C-reactive protein and serum fatty acid levels. We found a significant lowering effect of the intervention with white fish on waist circumference (P < 0.001) and diastolic blood pressure (P = 0.014). A significant lowering effect was also shown after the dietary intervention with fish on serum LDL concentrations (P = 0.048), whereas no significant effects were found on serum HDL or triglyceride concentrations. A significant rise (P < 0.001) in serum EPA and DHA fatty acids was observed following white fish consumption. Overall adherence to the intervention was good and no adverse events were found. In individuals with metabolic syndrome, regular consumption of hake reduces LDL cholesterol concentrations, waist circumference and blood pressure components of the metabolic syndrome. White Fish for Cardiovascular Risk Factors in Patients with Metabolic Syndrome Study, Registered under ClinicalTrials.gov Identifier: NCT01758601. Copyright © 2013 Elsevier B.V. All rights reserved.

Efficacy of aripiprazole augmentation in Japanese patients with major depressive disorder: a subgroup analysis and Montgomery-Åsberg Depression Rating Scale and Hamilton Rating Scale for Depression item analyses of the Aripiprazole Depression Multicenter Efficacy study.

PubMed

Ozaki, Norio; Otsubo, Tempei; Kato, Masaki; Higuchi, Teruhiko; Ono, Hiroaki; Kamijima, Kunitoshi

2015-01-01

Results from this randomized, placebo-controlled study of aripiprazole augmentation to antidepressant therapy (ADT) in Japanese patients with major depressive disorder (MDD) (the Aripiprazole Depression Multicenter Efficacy [ADMIRE] study) revealed that aripiprazole augmentation was superior to ADT alone and was well tolerated. In subgroup analyses, we investigated the influence of demographic- and disease-related factors on the observed responses. We also examined how individual symptom improvement was related to overall improvement in MDD. Data from the ADMIRE study were analyzed. Subgroup analyses were performed on the primary outcome measures: the mean change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from the end of selective serotonin reuptake inhibitor (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI) treatment to the end of the randomized treatment. Changes in the MADRS total scores were consistently greater with aripiprazole than placebo in each of the subgroups. Efficacy was not related to sex, age, number of adequate ADT trials in the current episode, MDD diagnosis, number of depressive episodes, duration of the current episode, age at first depressive episode, time since the first depressive episode, type of SSRI/SNRI, or severity at the end of SSRI/SNRI treatment phase. Compared to placebo, aripiprazole resulted in significant and rapid improvement on seven of the 10 MADRS items, including sadness. These post-hoc analyses indicated that aripiprazole was effective for a variety of Japanese patients with MDD who had exhibited inadequate responses to ADT. Additionally, we suggest that aripiprazole significantly and rapidly improved the core depressive symptoms. © 2014 The Authors. Psychiatry and Clinical Neurosciences © 2014 Japanese Society of Psychiatry and Neurology.

Internet Program for Physical Activity and Exercise Capacity in Children With Juvenile Idiopathic Arthritis: A Multicenter Randomized Controlled Trial.

PubMed

Armbrust, Wineke; Bos, G J F Joyce; Wulffraat, Nico M; van Brussel, Marco; Cappon, Jeannette; Dijkstra, Pieter U; Geertzen, Jan H B; Legger, G Elizabeth; van Rossum, Marion A J; Sauer, Pieter J J; Lelieveld, Otto T H M

2017-07-01

To determine the effects of Rheumates@Work, an internet-based program supplemented with 4 group sessions, aimed at improving physical activity, exercise capacity, health-related quality of life (HRQoL), and participation in children with juvenile idiopathic arthritis. Patients were recruited from 3 pediatric rheumatology centers in The Netherlands for an observer-blinded, randomized controlled multicenter trial. Physical activity level, time spent in rest, light, and moderate-to-vigorous physical activity (MVPA) were recorded in a diary and with an accelerometer, before intervention, after intervention, and at followup after 3 and 12 months (intervention group only). Exercise capacity was assessed using the Bruce treadmill protocol, HRQoL was assessed with the Pediatric Quality of Life Inventory generic core scale, and participation in school and in physical education classes were assessed by questionnaire. The intervention group consisted of 28 children, and there were 21 children in the control group. MVPA , exercise capacity, and participating in school and physical education classes improved significantly in the intervention group. HRQoL improved in the control group. No significant differences were found between groups. The effect of Rheumates@Work on physical activity and exercise capacity lasted during the 12 months of followup. Improvements in physical activity were significantly better for the cohort starting in winter compared to the summer cohort. Rheumates@Work had a positive, albeit small, effect on physical activity, exercise capacity, and participation in school and physical education class in the intervention group. Improvements lasted for 12 months. Participants who started in winter showed the most improvement. Rheumates@Work had no effect on HRQoL. © 2016, American College of Rheumatology.