Clinical trial of lutein in patients with retinitis pigmentosa receiving vitamin A treatment

USDA-ARS?s Scientific Manuscript database

We sought to determine whether lutein supplementation will slow visual function decline in patients with retinitis pigmentosa receiving vitamin A. DESIGN: Randomized, controlled, double-masked trial of 225 nonsmoking patients, aged 18 to 60 years, evaluated over a 4-year interval. Patients received ...

The hypocholesterolemic effect of an antacid containing aluminum hydroxide.

PubMed

Sperber, A D; Henkin, Y; Zuili, I; Bearman, J E; Shany, S

1991-12-01

To evaluate the efficacy, safety, and hypocholesterolemic effect of an aluminum hydroxide-containing antacid in hypercholesterolemic individuals. A prospective, randomized, double-masked, placebo-controlled phase of 2 months' duration, followed by an open-design treatment phase of 2 months' duration and a washout phase of 2 months' duration. Family practice clinics of two rural communities (kibbutzim) in Israel. Fifty-six men and women with hypercholesterolemia (type IIa or IIb). Fifty individuals completed the study. After 2 months of dietary modification (low-fat, low-cholesterol diet), the participants were randomized into two matched groups. Group 1 (28 participants) was treated for 2 months with a chewable antacid tablet containing simethicone, magnesium hydroxide, and 113 mg of aluminum hydroxide per tablet, at a dose of two tablets four times daily. Group 2 (22 participants) was given a similar number of placebo tablets for 2 months. During the following 2 months, both groups received the antacid at the above dose. Lipoprotein levels were evaluated at baseline and every 2 months thereafter for 6 months. Compared with pretreatment levels, Group 1 experienced a decrease in low-density lipoprotein cholesterol (LDL-C) of 9.8% after 2 months (p less than 0.001) and 18.5% after 4 months (p less than 0.001). Compared with Group 2, the decrease in LDL-C in Group 1 was 6.2% at the end of the 2-month double-masked, placebo phase. Although the high-density lipoprotein cholesterol (HDL-C) was also reduced in Group 1 at the end of 4 months of therapy (10.2%), the HDL-C/LDL-C ratio increased by 13% during the same interval (p less than 0.05). The treatment was well tolerated, with minimal side effects. An aluminum hydroxide-containing antacid reduces LDL-C in hypercholesterolemic individuals. Although HDL-C was also reduced to a lesser extent, the overall atherogenic index was improved. Further studies should be conducted to evaluate the long-term safety and efficacy of antacids containing aluminum hydroxide in hypercholesterolemic patients.

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

Agents for facilitation of laryngeal mask airway insertion: a comparative study between thiopentone sodium and propofol.

PubMed

Sengupta, Janmejoy; Sengupta, Mohua; Nag, Tulsi

2014-01-01

Development of endotracheal intubation to avoid deleterious effect on hemodynamic responses occurring during laryngoscopy and intubation compelled researchers to venture into alternative measures of airway management with subtle hemodynamic responses. This study was carried out to compare the conditions for laryngeal mask airways LMA insertion with widely used intravenous induction agents, thiopentone sodium and propofol, and also to compare the undesired responses occurring during LMA insertion with them. The study was prospective, randomized, and double blind. All patients selected were randomly allocated into two groups: Group 1 (propofol) and group II (thiopentone). Preinduction heart rate and blood pressure were recorded. Sixty healthy adult patients of either sex belonging to age group of 20-60 years and ASA grade I or II, to undergo surgery less than 1 h, were selected for the study-Patients were randomly allocated in two groups, 30 in each group. Premedication with midazolam 0.04 mg/kg and fentanyl 2 mg/kg done in both groups. Thereafter, group 1 was induced with 2 mg/kg of propofol and group 2 with 5 mg/kg of thiopentone sodium. The study revealed that, ease of insertion of LMA, was statistically significantly greater in group 1 when compared with group 2 (P 0.05). The time required for successful insertion of LMA was lesser in group 1 patients (53.8 ± 7.77 s) than in group 2 patients (84.7 ± 16.54 s) (P 0.001). Severity of undesired responses were more in group 2, as incremental boluses of respective induction agents were required in 20% patients in thiopentone group compared to only 6% patients in propofol group and 13% of patients in thiopentone group required rescue succinylcholine.

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.

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

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

ALOX5 gene variants affect eicosanoid production and response to fish oil supplementation

USDA-ARS?s Scientific Manuscript database

The objective of this study was to determine whether 5-lipoxygenase (ALOX5) gene variants associated with cardiovascular disease affect eicosanoid production by monocytes. The study was a randomized, double-masked, parallel intervention trial with fish oil (5.0 g of fish oil daily, containing 2.0 g ...

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

Devil's vortex Fresnel lens phase masks on an asymmetric cryptosystem based on phase-truncation in gyrator wavelet transform domain

NASA Astrophysics Data System (ADS)

Singh, Hukum

2016-06-01

An asymmetric scheme has been proposed for optical double images encryption in the gyrator wavelet transform (GWT) domain. Grayscale and binary images are encrypted separately using double random phase encoding (DRPE) in the GWT domain. Phase masks based on devil's vortex Fresnel Lens (DVFLs) and random phase masks (RPMs) are jointly used in spatial as well as in the Fourier plane. The images to be encrypted are first gyrator transformed and then single-level discrete wavelet transformed (DWT) to decompose LL , HL , LH and HH matrices of approximation, horizontal, vertical and diagonal coefficients. The resulting coefficients from the DWT are multiplied by other RPMs and the results are applied to inverse discrete wavelet transform (IDWT) for obtaining the encrypted images. The images are recovered from their corresponding encrypted images by using the correct parameters of the GWT, DVFL and its digital implementation has been performed using MATLAB 7.6.0 (R2008a). The mother wavelet family, DVFL and gyrator transform orders associated with the GWT are extra keys that cause difficulty to an attacker. Thus, the scheme is more secure as compared to conventional techniques. The efficacy of the proposed scheme is verified by computing mean-squared-error (MSE) between recovered and the original images. The sensitivity of the proposed scheme is verified with encryption parameters and noise attacks.

Information hiding based on double random-phase encoding and public-key cryptography.

PubMed

Sheng, Yuan; Xin, Zhou; Alam, Mohammed S; Xi, Lu; Xiao-Feng, Li

2009-03-02

A novel information hiding method based on double random-phase encoding (DRPE) and Rivest-Shamir-Adleman (RSA) public-key cryptosystem is proposed. In the proposed technique, the inherent diffusion property of DRPE is cleverly utilized to make up the diffusion insufficiency of RSA public-key cryptography, while the RSA cryptosystem is utilized for simultaneous transmission of the cipher text and the two phase-masks, which is not possible under the DRPE technique. This technique combines the complementary advantages of the DPRE and RSA encryption techniques and brings security and convenience for efficient information transmission. Extensive numerical simulation results are presented to verify the performance of the proposed technique.

Clinical outcomes of combined versus separate carbachol and brimonidine drops in correcting presbyopia.

PubMed

Abdelkader, Almamoun; Kaufman, Herbert E

2016-01-01

To test and compare in a masked fashion the efficacy of using a parasympathomimetic drug (3% carbachol) and an alpha-2 agonist (0.2% brimonidine) in both combined and separate forms to create optically beneficial miosis to pharmacologically improve vision in presbyopia. A prospective, double-masked, randomized, controlled clinical trial was conducted. Ten naturally emmetropic and presbyopic subjects between 42 and 58 years old with uncorrected distance visual acuity of at least 20/20 in both eyes without additional ocular pathology were eligible for inclusion. All subjects received 3% carbachol and 0.2% brimonidine in both combined and separate forms, 3% carbachol alone and 0.2% brimonidine (control) alone in their non-dominant eye in a crossover manner with one week washout between tests. The subjects' pupil sizes and both near and distance visual acuities will be evaluated pre- and post-treatment at 1, 2, 4, and 8 h, by a masked examiner at the same room illumination. Statistically significant improvement in mean near visual acuity (NVA) was achieved in all subjects who received combined 3% carbachol and 0.2% brimonidine in the same formula compared with those who received separate forms or carbachol alone or brimonidine alone ( P  < 0.0001). Based on the data, the combined solution demonstrated greater efficacy than the other solutions that were tested. Improving the depth of focus by making the pupil small caused statistically significant improvement in near visual acuity, with no change in binocular distance vision. ACTRN12616001565437. Registered 11 November 2016.

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.

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.

Improved decryption quality and security of a joint transform correlator-based encryption system

NASA Astrophysics Data System (ADS)

Vilardy, Juan M.; Millán, María S.; Pérez-Cabré, Elisabet

2013-02-01

Some image encryption systems based on modified double random phase encoding and joint transform correlator architecture produce low quality decrypted images and are vulnerable to a variety of attacks. In this work, we analyse the algorithm of some reported methods that optically implement the double random phase encryption in a joint transform correlator. We show that it is possible to significantly improve the quality of the decrypted image by introducing a simple nonlinear operation in the encrypted function that contains the joint power spectrum. This nonlinearity also makes the system more resistant to chosen-plaintext attacks. We additionally explore the system resistance against this type of attack when a variety of probability density functions are used to generate the two random phase masks of the encryption-decryption process. Numerical results are presented and discussed.

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

Molindone and haloperidol in tardive dyskinesia.

PubMed

Glazer, W M; Hafez, H M; Benarroche, C L

1985-08-01

Preliminary results are described from a study of 11 outpatients manifesting exacerbated tardive dyskinesia after tapering and withdrawal of neuroleptic medications. Patients were randomly assigned to molindone or haloperidol under double-blind placebo-controlled conditions to compare the masking effects of the two drugs. Haloperidol treatment masked withdrawal-exacerbated tardive dyskinesia more than molindone did; this difference (measured by percent change in AIMS scores) was significant (p = .04) when the dose was 200% but not 100% of the prestudy neuroleptic dose. Despite several limitations to the study, the results suggest that molindone may have less dyskinetogenic potential than haloperidol. Further research in the area of site-specificity of molindone is indicated.

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.

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.

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

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

Comparison of 2 cuff inflation methods of laryngeal mask airway Classic for safe use without cuff manometer in adults.

PubMed

Kim, Min-Soo; Lee, Jeong-Rim; Shin, Yang-Sik; Chung, Ji-Won; Lee, Kyu-Ho; Ahn, Ki Ryang

2014-03-01

This single-center, prospective, randomized, double-blind, 2-arm, parallel group comparison trial was performed to establish whether the adult-sized laryngeal mask airway (LMA) Classic (The Laryngeal Mask Company Ltd, Henley-on-Thames, UK) could be used safely without any consideration of cuff hyperinflation when a cuff of the LMA Classic was inflated using half the maximum inflation volume or the resting volume before insertion of device. Eighty patients aged 20 to 70 years scheduled for general anesthesia using the LMA Classic were included. Before insertion, the cuff was partially filled with half the maximum inflation volume in the half volume group or the resting volume created by opening the pilot balloon valve to equalize with atmospheric pressure in the resting volume group. Several parameters regarding insertion, intracuff pressure, airway leak pressure, and leakage volume/fraction were collected after LMA insertion. The LMA Classic with a partially inflated cuff was successfully inserted in all enrolled patients. Both groups had the same success rate of 95% at the first insertion attempt. The half volume group had a lower mean intracuff pressure compared with the resting volume group (54.5 ± 16.1 cm H2O vs 61.8 ± 16.1 cm H2O; P = .047). There was no difference in airway leak pressure or leakage volume/fraction between the 2 groups under mechanical ventilation. The partially inflated cuff method using half the maximum recommended inflation volume or the resting volume is feasible with the adult-sized LMA Classic, resulting in a high success rate of insertion and adequate range of intracuff pressures. Copyright © 2014 Elsevier Inc. All rights reserved.

Effects of specific alpha-1A/1D blocker on lower urinary tract symptoms due to double-J stent: a prospectively randomized study.

PubMed

Wang, Chung-Jing; Huang, Shi-Wei; Chang, Chien-Hsing

2009-06-01

The aim of our study was to evaluate the effect of tamsulosin in improving symptoms in patients with indwelling double-J ureteral stents. This prospective study lasted from April 2006 to March 2008. All the patients with symptomatic lower ureteral stones with <15 mm diameter were enrolled, and were prospectively randomized (random numbers table) into two groups. A total of 154 patients, with insertion of a double-J ureteral stent after ureteroscopic stone removal. In group 1, 75 patients were enrolled and received placebo for 2 weeks. Group 2 included 79 patients who received 0.4 mg of tamsulosin, once daily for 2 weeks. All patients completed the validated ureteral stent symptom questionnaire (USSQ) and quality of life of international prostate symptom scale (IPSS) for evaluating the symptoms of double-J stents and quality of life after double-J stent insertion and removal, respectively. The analysis of the questionnaire at W1 revealed a significant difference in the main score index of urinary symptoms, body pain and general health between groups 1 and 2. When comparing W1 evaluation with that of W4 after double-J removal, both groups showed significant worsening of urinary symptoms, body pain, general health and work performance, except sexual performance. The mean score of quality of life in IPSS was 4.21 in group 1 and 1.6 in group 2. Tamsulosin can improve a subset of stent-related urinary symptoms and quality of life effectively and may be applied in routine clinical practice.

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.

Travoprost 0.004%/timolol 0.5%-fixed combination with and without benzalkonium chloride: a prospective, randomized, doubled-masked comparison of safety and efficacy

PubMed Central

Kitazawa, Y; Smith, P; Sasaki, N; Kotake, S; Bae, K; Iwamoto, Y

2011-01-01

Purpose The purpose of this study is to compare the safety and intraocular pressure (IOP)-lowering efficacy of travoprost/timolol in a benzalkonium chloride (BAK)-free fixed combination preserved with polyquaternium-1 (TRA/TIM BAK-free), with travoprost/timolol-fixed combination preserved with BAK (TRA/TIM), in patients with open-angle glaucoma or ocular hypertension. Methods In this prospective randomized controlled trial, subjects with IOP of at least 22 mm Hg in one or both eyes at 0900 h, and IOP of at least 21 mm Hg in one or both eyes at 1100 h and 1600 h at two eligibility visits were randomly assigned to receive either TRA/TIM BAK-free (n=195) or TRA/TIM (n=193), dosed once daily in the morning (0900 h) for 6 weeks. IOP was assessed at 0900 h, 1100 h, and 1600 h at each scheduled visit (baseline, 2 and 6 weeks after randomization). Results Mean IOP reduction across all visits and time points was 8.0 mm Hg in the TRA/TIM BAK-free group and 8.4 mm Hg in the TRA/TIM group (P=0.0943). The difference in mean IOP between groups ranged from 0.2 to 0.7 mm Hg across visits and time points, with a mean pooled difference of 0.4 mm Hg (95% CI: −0.1 to 0.8), demonstrating equivalence of the two formulations. The most common drug-related adverse event was hyperemia of the eye (ocular hyperemia and conjunctival hyperemia combined), occurring in 11.8% of the TRA/TIM BAK-free group and 13.0% of the TRA/TIM group. Conclusion Travoprost/timolol BAK-free demonstrated equivalence to travoprost/timolol preserved with BAK in efficacy. No clinically relevant differences in the safety profiles of travoprost/timolol BAK-free and travoprost/timolol preserved with BAK were identified. PMID:21701528

Travoprost 0.004%/timolol 0.5%-fixed combination with and without benzalkonium chloride: a prospective, randomized, doubled-masked comparison of safety and efficacy.

PubMed

Kitazawa, Y; Smith, P; Sasaki, N; Kotake, S; Bae, K; Iwamoto, Y

2011-09-01

The purpose of this study is to compare the safety and intraocular pressure (IOP)-lowering efficacy of travoprost/timolol in a benzalkonium chloride (BAK)-free fixed combination preserved with polyquaternium-1 (TRA/TIM BAK-free), with travoprost/timolol-fixed combination preserved with BAK (TRA/TIM), in patients with open-angle glaucoma or ocular hypertension. In this prospective randomized controlled trial, subjects with IOP of at least 22  mm Hg in one or both eyes at 0900  h, and IOP of at least 21  mm Hg in one or both eyes at 1100  h and 1600  h at two eligibility visits were randomly assigned to receive either TRA/TIM BAK-free (n=195) or TRA/TIM (n=193), dosed once daily in the morning (0900  h) for 6 weeks. IOP was assessed at 0900  h, 1100  h, and 1600  h at each scheduled visit (baseline, 2 and 6 weeks after randomization). Mean IOP reduction across all visits and time points was 8.0  mm Hg in the TRA/TIM BAK-free group and 8.4  mm Hg in the TRA/TIM group (P=0.0943). The difference in mean IOP between groups ranged from 0.2 to 0.7  mm Hg across visits and time points, with a mean pooled difference of 0.4  mm Hg (95% CI: -0.1 to 0.8), demonstrating equivalence of the two formulations. The most common drug-related adverse event was hyperemia of the eye (ocular hyperemia and conjunctival hyperemia combined), occurring in 11.8% of the TRA/TIM BAK-free group and 13.0% of the TRA/TIM group. Travoprost/timolol BAK-free demonstrated equivalence to travoprost/timolol preserved with BAK in efficacy. No clinically relevant differences in the safety profiles of travoprost/timolol BAK-free and travoprost/timolol preserved with BAK were identified.

Emergence times and airway reactions in general laryngeal mask airway anesthesia: study protocol for a randomized controlled trial.

PubMed

Stevanovic, Ana; Rossaint, Rolf; Keszei, András P; Fritz, Harald; Fröba, Gebhard; Pühringer, Friedrich; Coburn, Mark

2015-07-26

The use of a laryngeal mask airway (LMA) in appropriate patients supports fast-track anesthesia with a lower incidence of postoperative airway-connected adverse events. Data on the most favorable anesthetic in this context, with the lowest rate of upper airway complications and fast emergence times, are controversial and limited. Desflurane seems to match these criteria best, but large randomized controlled trials (RCTs) with a standardized study protocol are lacking. Therefore, we aim to compare desflurane with other commonly used anesthetics, sevoflurane and propofol, in a sufficiently powered RCT. We hypothesize that desflurane is noninferior regarding the frequency of upper airway events and superior regarding the emergence times to sevoflurane and propofol. A total of 351 patients undergoing surgery with an LMA will be included in this prospective, randomized, double-blind controlled, multicenter clinical trial. The patients will be randomly assigned to the three treatment arms: desflurane (n = 117), sevoflurane (n = 117), and propofol (n = 117). The emergence time (time to state the date of birth) will be the primary endpoint of this study. The secondary endpoints include further emergence times, such as time to open eyes, to remove LMA, to respond to command and to state name. Additionally, we will determine the frequency of cough and laryngospasm, measured intraoperatively and at emergence. We will assess the postoperative recovery on the first postoperative day via the Postoperative Quality Recovery Scale. Despite increasing importance of cost-effective and safe anesthesia application, we lack proof for the most advantageous anesthetic agent, when an LMA is used. There are only a few RCTs comparing desflurane to other commonly used anesthetics (sevoflurane, propofol and isoflurane) in patients with LMA. These RCTs were conducted with small sample sizes, huge interstudy variability, and some also showed strong biases. The present multicenter RCT will provide results from a large sample size with a standardized study protocol and minimized bias, which is feasible in the clinical routine. Furthermore, we will expand our knowledge regarding the most favorable recovery on the first postoperative day, which impacts patients' comfort after surgery. EudraCT Identifier: 2014-003810-96, 5 September 2014 ClinicalTrials.gov: NCT02322502, December 2014.

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.

A Randomized Comparison of Aripiprazole and Risperidone for the Acute Treatment of First-Episode Schizophrenia and Related Disorders: 3-Month Outcomes

PubMed Central

Robinson, Delbert G.; Gallego, Juan A.; John, Majnu; Petrides, Georgios; Hassoun, Youssef; Zhang, Jian-Ping; Lopez, Leonardo; Braga, Raphael J.; Sevy, Serge M.; Addington, Jean; Kellner, Charles H.; Tohen, Mauricio; Naraine, Melissa; Bennett, Natasha; Greenberg, Jessica; Lencz, Todd; Correll, Christoph U.; Kane, John M.; Malhotra, Anil K.

2015-01-01

Research findings are particularly important for medication choice for first-episode patients as individual prior medication response to guide treatment decisions is unavailable. We describe the first large-scale double-masked randomized comparison with first-episode patients of aripiprazole and risperidone, 2 commonly used first-episode treatment agents. One hundred ninety-eight participants aged 15–40 years with schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder Not Otherwise Specified, and who had been treated in their lifetime with antipsychotics for 2 weeks or less were randomly assigned to double-masked aripiprazole (5–30mg/d) or risperidone (1–6mg/d) and followed for 12 weeks. Positive symptom response rates did not differ (62.8% vs 56.8%) nor did time to response. Aripiprazole-treated participants had better negative symptom outcomes but experienced more akathisia. Body mass index change did not differ between treatments but advantages were found for aripiprazole treatment for total and low-density lipoprotein cholesterol, fasting glucose, and prolactin levels. Post hoc analyses suggested advantages for aripiprazole on depressed mood. Overall, if the potential for akathisia is a concern, low-dose risperidone as used in this trial maybe a preferred choice over aripiprazole. Otherwise, aripiprazole would be the preferred choice over risperidone in most situations based upon metabolic outcome advantages and some symptom advantages within the context of similar positive symptom response between medications. PMID:26338693

Double image encryption in Fresnel domain using wavelet transform, gyrator transform and spiral phase masks

NASA Astrophysics Data System (ADS)

Kumar, Ravi; Bhaduri, Basanta

2017-06-01

In this paper, we propose a new technique for double image encryption in the Fresnel domain using wavelet transform (WT), gyrator transform (GT) and spiral phase masks (SPMs). The two input mages are first phase encoded and each of them are then multiplied with SPMs and Fresnel propagated with distances d1 and d2, respectively. The single-level discrete WT is applied to Fresnel propagated complex images to decompose each into sub-band matrices i.e. LL, HL, LH and HH. Further, the sub-band matrices of two complex images are interchanged after modulation with random phase masks (RPMs) and subjected to inverse discrete WT. The resulting images are then both added and subtracted to get intermediate images which are further Fresnel propagated with distances d3 and d4, respectively. These outputs are finally gyrator transformed with the same angle α to get the encrypted images. The proposed technique provides enhanced security in terms of a large set of security keys. The sensitivity of security keys such as SPM parameters, GT angle α, Fresnel propagation distances are investigated. The robustness of the proposed techniques against noise and occlusion attacks are also analysed. The numerical simulation results are shown in support of the validity and effectiveness of the proposed technique.

Effect of levodopa and carbidopa in human amblyopia.

PubMed

Pandey, P K; Chaudhuri, Zia; Kumar, Maneesh; Satyabala, K; Sharma, Pankaj

2002-01-01

To assess the role of continuous therapy for 3 weeks with levodopa and carbidopa in the management of human amblyopia in children and adults. There were 88 amblyopic eyes of 82 subjects included in this double masked randomized prospective clinical trial. Levodopa and carbidopa combination in 2 different dosage schedules were given to both adults and children. The response was monitored of the improvement in visual acuity, contrast sensitivity, and visually evoked potentials. Patients receiving higher dosages of levodopa and carbidopa in both adults and children showed a better response to treatment. However, the effect did not last beyond 9 weeks of stopping treatment. Though levodopa and carbidopa therapy may not be able to ameliorate amblyopia on its own on a long-term basis, it may be considered nonetheless to be an important adjunct to conventional therapy because it may improve patient compliance for occlusion by improving visual acuity in the amblyopic eye. Thus, it offers promise of improving the functional outcome in these cases. However, longer follow-up trials are needed to substantiate these conclusions.

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%.

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.

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.

Design architecture of double spiral interdigitated electrode with back gate electrode for biosensor application

NASA Astrophysics Data System (ADS)

Fathil, M. F. M.; Arshad, M. K. Md.; Hashim, U.; Ruslinda, A. R.; Gopinath, Subash C. B.; M. Nuzaihan M., N.; Ayub, R. M.; Adzhri, R.; Zaki, M.; Azman, A. H.

2016-07-01

This paper presents the preparation method of photolithography chrome mask design used in fabrication process of double spiral interdigitated electrode with back gate biasing based biosensor. By learning the fabrication process flow of the biosensor, the chrome masks are designed through drawing using the AutoCAD software. The overall width and length of the device is optimized at 7.0 mm and 10.0 mm, respectively. Fabrication processes of the biosensor required three chrome masks, which included back gate opening, spiral IDE formation, and passivation area formation. The complete chrome masks design will be sent for chrome mask fabrication and for future use in biosensor fabrication.

Buffered Lidocaine With Sodium Bicarbonate did not Increase Inferior Alveolar Nerve Block Success Rate in Patients Having Symptomatic Irreversible Pulpitis.

PubMed

Parirokh, Masoud

2016-03-01

Effect of buffered 4% lidocaine on the success of the inferior alveolar nerve block in patients with symptomatic irreversible pulpitis: a prospective, randomized, double-blind study. Schellenberg J, Drum M, Reader A, Nusstein J, Fowler S, Beck M. J Endod 2015;41(6):791-6. The study was supported by Meyers/Reader Graduate Endodontic Support Fund Double blinded randomized controlled trial. Copyright © 2016 Elsevier Inc. All rights reserved.

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.

Imposed Power of Breathing Associated With Use of an Impedance Threshold Device

DTIC Science & Technology

2007-02-01

threshold device and a sham impedance threshold device. DESIGN: Prospective randomized blinded protocol. SETTING: University medical center. PATIENTS...for males). METHODS: The volunteers completed 2 trials of breathing through a face mask fitted with an active impedance threshold device set to open...at -7cmH 2 O pressure, or with a sham impedance threshold device, which was identical to the active device except that it did not contain an

Optical double-image cryptography based on diffractive imaging with a laterally-translated phase grating.

PubMed

Chen, Wen; Chen, Xudong; Sheppard, Colin J R

2011-10-10

In this paper, we propose a method using structured-illumination-based diffractive imaging with a laterally-translated phase grating for optical double-image cryptography. An optical cryptosystem is designed, and multiple random phase-only masks are placed in the optical path. When a phase grating is laterally translated just before the plaintexts, several diffraction intensity patterns (i.e., ciphertexts) can be correspondingly obtained. During image decryption, an iterative retrieval algorithm is developed to extract plaintexts from the ciphertexts. In addition, security and advantages of the proposed method are analyzed. Feasibility and effectiveness of the proposed method are demonstrated by numerical simulation results. © 2011 Optical Society of America

Variability-aware double-patterning layout optimization for analog circuits

NASA Astrophysics Data System (ADS)

Li, Yongfu; Perez, Valerio; Tripathi, Vikas; Lee, Zhao Chuan; Tseng, I.-Lun; Ong, Jonathan Yoong Seang

2018-03-01

The semiconductor industry has adopted multi-patterning techniques to manage the delay in the extreme ultraviolet lithography technology. During the design process of double-patterning lithography layout masks, two polygons are assigned to different masks if their spacing is less than the minimum printable spacing. With these additional design constraints, it is very difficult to find experienced layout-design engineers who have a good understanding of the circuit to manually optimize the mask layers in order to minimize color-induced circuit variations. In this work, we investigate the impact of double-patterning lithography on analog circuits and provide quantitative analysis for our designers to select the optimal mask to minimize the circuit's mismatch. To overcome the problem and improve the turn-around time, we proposed our smart "anchoring" placement technique to optimize mask decomposition for analog circuits. We have developed a software prototype that is capable of providing anchoring markers in the layout, allowing industry standard tools to perform automated color decomposition process.

Phase-Image Encryption Based on 3D-Lorenz Chaotic System and Double Random Phase Encoding

NASA Astrophysics Data System (ADS)

Sharma, Neha; Saini, Indu; Yadav, AK; Singh, Phool

2017-12-01

In this paper, an encryption scheme for phase-images based on 3D-Lorenz chaotic system in Fourier domain under the 4f optical system is presented. The encryption scheme uses a random amplitude mask in the spatial domain and a random phase mask in the frequency domain. Its inputs are phase-images, which are relatively more secure as compared to the intensity images because of non-linearity. The proposed scheme further derives its strength from the use of 3D-Lorenz transform in the frequency domain. Although the experimental setup for optical realization of the proposed scheme has been provided, the results presented here are based on simulations on MATLAB. It has been validated for grayscale images, and is found to be sensitive to the encryption parameters of the Lorenz system. The attacks analysis shows that the key-space is large enough to resist brute-force attack, and the scheme is also resistant to the noise and occlusion attacks. Statistical analysis and the analysis based on correlation distribution of adjacent pixels have been performed to test the efficacy of the encryption scheme. The results have indicated that the proposed encryption scheme possesses a high level of security.

Double exposure using 193nm negative tone photoresist

NASA Astrophysics Data System (ADS)

Kim, Ryoung-han; Wallow, Tom; Kye, Jongwook; Levinson, Harry J.; White, Dave

2007-03-01

Double exposure is one of the promising methods for extending lithographic patterning into the low k I regime. In this paper, we demonstrate double patterning of k 1-effective=0.25 with improved process window using a negative resist. Negative resist (TOK N- series) in combination with a bright field mask is proven to provide a large process window in generating 1:3 = trench:line resist features. By incorporating two etch transfer steps into the hard mask material, frequency doubled patterns could be obtained.

Outcomes of the modified Brostrom procedure using suture anchors for chronic lateral ankle instability--a prospective, randomized comparison between single and double suture anchors.

PubMed

Cho, Byung-Ki; Kim, Yong-Min; Kim, Dong-Soo; Choi, Eui-Sung; Shon, Hyun-Chul; Park, Kyoung-Jin

2013-01-01

The present prospective, randomized study was conducted to compare the clinical outcomes of the modified Brostrom procedure using single and double suture anchors for chronic lateral ankle instability. A total of 50 patients were followed up for more than 2 years after undergoing the modified Brostrom procedure. Of the 50 procedures, 25 each were performed using single and double suture anchors by 1 surgeon. The Karlsson scale had improved significantly to 89.8 points and 90.6 points in the single and double anchor groups, respectively. Using the Sefton grading system, 23 cases (92%) in the single anchor group and 22 (88%) in the double anchor group achieved satisfactory results. The talar tilt angle and anterior talar translation on stress radiographs using the Telos device had improved significantly to an average of 5.7° and 4.6 mm in the single anchor group and 4.5° and 4.3 mm in the double anchor group, respectively. The double anchor technique was superior with respect to the postoperative talar tilt. The single and double suture anchor techniques produced similar clinical and functional outcomes, with the exception of talar tilt as a reference of mechanical stability. The modified Brostrom procedure using both single and double suture anchors appears to be an effective treatment method for chronic lateral ankle instability. Copyright © 2013 American College of Foot and Ankle Surgeons. Published by Elsevier Inc. All rights reserved.

65-nm full-chip implementation using double dipole lithography

NASA Astrophysics Data System (ADS)

Hsu, Stephen D.; Chen, J. Fung; Cororan, Noel; Knose, William T.; Van Den Broeke, Douglas J.; Laidig, Thomas L.; Wampler, Kurt E.; Shi, Xuelong; Hsu, Michael; Eurlings, Mark; Finders, Jo; Chiou, Tsann-Bim; Socha, Robert J.; Conley, Will; Hsieh, Yen W.; Tuan, Steve; Hsieh, Frank

2003-06-01

Double Dipole Lithography (DDL) has been demonstrated to be capable of patterning complex 2D patterns. Due to inherently high aerial imaging contrast, especially for dense features, we have found that it has a very good potential to meet manufacturing requirements for the 65nm node using ArF binary chrome masks. For patterning in the k1<0.35 regime without resorting to hard phase-shift masks (PSMs), DDL is one unique Resolution Enhancement Technique (RET) which can achieve an acceptable process window. To utilize DDL for printing actual IC devices, the original design data must be decomposed into "vertical (V)" and "horizontal (H)" masks for the respective X- and Y-dipole exposures. An improved two-pass, model-based, DDL mask data processing methodology has been established. It is capable of simultaneously converting complex logic and memory mask patterns into DDL compatible mask layout. To maximize the overlapped process window area, we have previously shown that the pattern-shielding algorithm must be intelligently applied together with both Scattering Bars (SBs) and model-based OPC (MOPC). Due to double exposures, stray light must be well-controlled to ensure uniform printing across the entire chip. One solution to minimize stray light is to apply large patches of solid chrome in open areas to reduce the background transmission during exposure. Unfortunately, this is not feasible for a typical clear-field poly gate masks to be patterned by a positive resist process. In this work, we report a production-worthy DDL mask pattern decomposition scheme for full-chip application. A new generation of DDL technology reticle set has been developed to verify the printing performance. Shielding is a critical part of the DDL. An innovative shielding scheme has been developed to protect the critical features and minimize the impact of stray light during double exposure.

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.

A Prospective, Randomized, Double-Blind Comparison of 2% Mepivacaine With 1 : 20,000 Levonordefrin Versus 2% Lidocaine With 1 : 100,000 Epinephrine for Maxillary Infiltrations

PubMed Central

Lawaty, Ingrid; Drum, Melissa; Reader, Al; Nusstein, John

2010-01-01

The purpose of this prospective, randomized, double-blind crossover study was to compare the anesthetic efficacy of 2% mepivacaine with 1 : 20,000 levonordefrin versus 2% lidocaine with 1 : 100,000 epinephrine in maxillary central incisors and first molars. Sixty subjects randomly received, in a double-blind manner, maxillary central incisor and first molar infiltrations of 1.8 mL of 2% mepivacaine with 1 : 20,000 levonordefrin and 1.8 mL of 2% lidocaine with 1 : 100,000 epinephrine at 2 separate appointments spaced at least 1 week apart. The teeth were electric pulp tested in 2-minute cycles for a total of 60 minutes. Anesthetic success (obtaining 2 consecutive 80 readings with the electric pulp tester within 10 minutes) was not significantly different between 2% mepivacaine with 1 : 20,000 levonordefrin and 2% lidocaine with 1 : 100,000 epinephrine for the central incisor and first molar. However, neither anesthetic agent provided an hour of pulpal anesthesia. PMID:21174567

Double-layer versus single-layer bone-patellar tendon-bone anterior cruciate ligament reconstruction: a prospective randomized study with 3-year follow-up.

PubMed

Mei, Xiaoliang; Zhang, Zhenxiang; Yang, Jingwen

2016-12-01

To evaluate the clinical results of a randomized controlled trial of single-layer versus double-layer bone-patellar tendon-bone (BPTB) anterior cruciate ligament (ACL) reconstruction. Fifty-eight subjects who underwent primary ACL reconstruction with a BPTB allograft were prospectively randomized into two groups: single-layer reconstruction (n = 31) and double-layer reconstruction (n = 27). The following evaluation methods were used: clinical examination, KT-1000 arthrometer measurement, muscle strength, Tegner activity score, Lysholm score, subjective rating scale regarding patient satisfaction and sports performance level, graft retear, contralateral ACL tear, and additional meniscus surgery. Forty-eight subjects (24 in single-layer group and 24 in double-layer group) who were followed up for 3 years were evaluated. Preoperatively, there were no differences between the groups. At 3-year follow-up, the Lachman and pivot-shift test results were better in the double-layer group (P = 0.019 and P < 0.0001, respectively). KT measurements were better in the double-layer group (mean 2.9 versus 1.5 mm; P = 0.0025). The Tegner score was also better in the double-layer group (P = 0.024). There were no significant differences in range of motion, muscle strength, Lysholm score, subjective rating scale, graft retear, and secondary meniscal tear. In ACL reconstruction, double-layer BPTB reconstruction was significantly better than single-layer reconstruction regarding anterior and rotational stability at 3-year follow-up. The results of KT measurements and the Lachman and pivot-shift tests were significantly better in the double-layer group, whereas there was no difference in the anterior drawer test results. The Tegner score was also better in the double-layer group; however, there were no differences in the other subjective findings.

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.

Sublingual misoprostol as an adjunct to oxytocin during cesarean delivery in women at risk of postpartum hemorrhage.

PubMed

Chaudhuri, Picklu; Majumdar, Arindam

2015-01-01

To evaluate whether a combination of misoprostol and oxytocin more effectively reduces blood loss during and after cesarean delivery than does oxytocin alone among women with known risk factors for postpartum hemorrhage (PPH). A prospective, randomized, double-blind, placebo-controlled trial was performed at a tertiary care center in Kolkata, India, between October 2012 and December 2013. Women were eligible if they were undergoing emergency cesarean under spinal anesthesia and were at high risk for PPH. Participants were randomly assigned (1:1) to receive 400 μg misoprostol or matched placebo sublingually after delivery of the newborn using a computer-generated random number sequence (block size eight). Participants and providers were masked to assignment. All participants received 20 IU oxytocin. The primary outcomes were intraoperative and postoperative blood loss. Both groups contained 198 women. Mean intraoperative blood loss was significantly lower in the misoprostol group (505.4±215.5 mL) than in the placebo group (587.3±201.5 mL; P<0.001). Mean postoperative blood loss was slightly lower in the misoprostol group (96.9±57.3 mL) than in the placebo group (103.4±58.4 mL; P=0.07). Shivering and pyrexia were more frequently associated with misoprostol (P<0.05 for both). Misoprostol as an adjunct to oxytocin seemed to more effectively reduce blood loss than did oxytocin alone. Clinical Trial Registry India:CTRI/2013/05/003645. Copyright © 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Reducing Dental Plaque and Gingivitis With 0.6% Cortex Ilicis Rotundae Toothpaste: A Randomized, Double-Masked Clinical Trial.

PubMed

Liu, Hongchun; Yin, Wei

2016-03-01

Cortex Ilicis Rotundae has antioxidant and anti-inflammatory properties. Few studies have evaluated the effects of toothpastes containing Cortex Ilicis Rotundae. This study evaluates the antiplaque and antigingivitis effects of a test toothpaste containing 0.6% Cortex Ilicis Rotundae extract in a calcium carbonate base compared with a control toothpaste without any active ingredient. One hundred adults with a mean plaque index (PI) ≥ 1.5 and a mean gingival index (GI) ≥ 1.0 were enrolled in this randomized, double-masked, placebo-controlled clinical trial. They were assigned randomly to use a test toothpaste or a control toothpaste. At baseline, 6 weeks, and 12 weeks, they received examinations of oral hard and soft tissues, using Löe-Silness GI for gingivitis and the Turesky modification of the Quigley-Hein PI for PI. Adverse events were monitored. When the study was completed, the test group reported lower mean GI than the control group (1.13 ± 0.22 versus 1.30 ± 0.23; P = 0.001) and lower mean PI than the control group (2.53 ± 0.5 versus 2.93 ± 0.44; P < 0.001). Compared to the baseline, the test group had reductions in GI and PI of 14.39% and 17.86%, respectively (both P < 0.001); the control group had reductions in GI and PI of 3.7% and 3.93%, respectively (both P < 0.001). No adverse events were reported during the course of the study. The toothpaste containing 0.6% Cortex Ilicis Rotundae was effective in reducing dental plaque and gingivitis after 12 weeks of use compared with a negative control toothpaste.

Saccharomyces boulardii to Prevent Antibiotic-Associated Diarrhea: A Randomized, Double-Masked, Placebo-Controlled Trial.

PubMed

Ehrhardt, Stephan; Guo, Nan; Hinz, Rebecca; Schoppen, Stefanie; May, Jürgen; Reiser, Markus; Schroeder, Maximilian Philipp; Schmiedel, Stefan; Keuchel, Martin; Reisinger, Emil C; Langeheinecke, Andreas; de Weerth, Andreas; Schuchmann, Marcus; Schaberg, Tom; Ligges, Sandra; Eveslage, Maria; Hagen, Ralf M; Burchard, Gerd D; Lohse, Ansgar W

2016-01-01

Background.  Antibiotic-associated diarrhea (AAD) and Clostridium difficile-associated diarrhea (CDAD) are common complications of antibiotic use. Data on the efficacy of probiotics to prevent AAD and CDAD are unclear. We aimed to evaluate the efficacy of Saccharomyces boulardii to prevent AAD and CDAD in hospitalized adult patients. Methods.  We conducted a multicenter, phase III, double-masked, randomized, placebo-controlled trial in hospitalized patients who received systemic antibiotic treatment in 15 hospitals in Germany between July 2010 and October 2012. Participants received Perenterol forte 250 mg capsules or matching placebo twice per day within 24 hours of initiating antibiotic treatment, continued treatment for 7 days after antibiotic discontinuation, and were then observed for 6 weeks. Results.  Two thousand four hundred forty-four patients were screened. The trial was stopped early for futility after inclusion of 477 participants. Two hundred forty-six patients aged 60.1 ± 16.5 years and 231 patients aged 56.5 ± 17.8 were randomized to the S boulardii group and the placebo group, respectively, with 21 and 19 AADs in the respective groups (P = .87). The hazard ratio of AAD in the S boulardii group compared with the placebo group was 1.02 (95% confidence interval, .55-1.90; P = .94). Clostridium difficile-associated diarrhea occurred in 0.8% of participants (4 of 477). Nine serious adverse events were recorded in the S boulardii group, and 3 serious adverse events were recorded in the placebo group. None were related to study participation. Conclusions.  We found no evidence for an effect of S boulardii in preventing AAD or CDAD in a population of hospitalized patients without particular risk factors apart from systemic antibiotic treatment. ClinicalTrials.gov Identifier.  NCT01143272.

Effects of a Lutein and Zeaxanthin Intervention on Cognitive Function: A Randomized, Double-Masked, Placebo-Controlled Trial of Younger Healthy Adults.

PubMed

Renzi-Hammond, Lisa M; Bovier, Emily R; Fletcher, Laura M; Miller, L Stephen; Mewborn, Catherine M; Lindbergh, Cutter A; Baxter, Jeffrey H; Hammond, Billy R

2017-11-14

Background: Past studies have suggested that higher lutein (L) and zeaxanthin (Z) levels in serum and in the central nervous system (as quantified by measuring macular pigment optical density, MPOD) are related to improved cognitive function in older adults. Very few studies have addressed the issue of xanthophylls and cognitive function in younger adults, and no controlled trials have been conducted to date to determine whether or not supplementation with L + Z can change cognitive function in this population. Objective: The purpose of this study was to determine whether or not supplementation with L + Z could improve cognitive function in young (age 18-30), healthy adults. Design: A randomized, double-masked, placebo-controlled trial design was used. Fifty-one young, healthy subjects were recruited as part of a larger study on xanthophylls and cognitive function. Subjects were randomized into active supplement ( n = 37) and placebo groups ( n = 14). MPOD was measured psychophysically using customized heterochromatic flicker photometry. Cognitive function was measured using the CNS Vital Signs testing platform. MPOD and cognitive function were measured every four months for a full year of supplementation. Results: Supplementation increased MPOD significantly over the course of the year, vs. placebo ( p < 0.001). Daily supplementation with L + Z and increases in MPOD resulted in significant improvements in spatial memory ( p < 0.04), reasoning ability ( p < 0.05) and complex attention ( p < 0.04), above and beyond improvements due to practice effects. Conclusions: Supplementation with L + Z improves CNS xanthophyll levels and cognitive function in young, healthy adults. Magnitudes of effects are similar to previous work reporting correlations between MPOD and cognition in other populations.

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.

Results of a Multicenter, Randomized, Double-Masked, Placebo-Controlled Clinical Study of the Efficacy and Safety of Visomitin Eye Drops in Patients with Dry Eye Syndrome.

PubMed

Brzheskiy, Vladimir V; Efimova, Elena L; Vorontsova, Tatiana N; Alekseev, Vladimir N; Gusarevich, Olga G; Shaidurova, Ksenia N; Ryabtseva, Alla A; Andryukhina, Olga M; Kamenskikh, Tatiana G; Sumarokova, Elena S; Miljudin, Eugeny S; Egorov, Eugeny A; Lebedev, Oleg I; Surov, Alexander V; Korol, Andrii R; Nasinnyk, Illia O; Bezditko, Pavel A; Muzhychuk, Olena P; Vygodin, Vladimir A; Yani, Elena V; Savchenko, Alla Y; Karger, Elena M; Fedorkin, Oleg N; Mironov, Alexander N; Ostapenko, Victoria; Popeko, Natalia A; Skulachev, Vladimir P; Skulachev, Maxim V

2015-12-01

This article presents the results of an international, multicenter, randomized, double-masked, placebo-controlled clinical study of Visomitin (Mitotech LLC, Moscow, Russian Federation) eye drops in patients with dry eye syndrome (DES). Visomitin is the first registered (in Russia) drug with a mitochondria-targeted antioxidant (SkQ1) as the active ingredient. In this multicenter (10 sites) study of 240 subjects with DES, study drug (Visomitin or placebo) was self-administered three times daily (TID) for 6 weeks, followed by a 6-week follow-up period. Seven in-office study visits occurred every 2 weeks during both the treatment and follow-up periods. Efficacy measures included Schirmer's test, tear break-up time, fluorescein staining, meniscus height, and visual acuity. Safety measures included adverse events, slit lamp biomicroscopy, tonometry, blood pressure, and heart rate. Tolerability was also evaluated. This clinical study showed the effectiveness of Visomitin eye drops in the treatment of signs and symptoms of DES compared with placebo. The study showed that a 6-week course of TID topical instillation of Visomitin significantly improved the functional state of the cornea; Visomitin increased tear film stability and reduced corneal damage. Significant reduction of dry eye symptoms (such as dryness, burning, grittiness, and blurred vision) was also observed. Based on the results of this study, Visomitin is effective and safe for use in eye patients with DES for protection from corneal damage. Mitotech LLC.

Airway difficulty in Mallampati 'class zero' patients: a prospective double-blind observational study.

PubMed

Hegde, Harihar V; Prasad, Kothegala C; Bhat, Manjunath T; Hegde, Jyothirmay S; Santhosh Mysore, C b; Yaliwal, Vijay G; Raghavendra Rao, P

2012-07-01

Assessment of Mallampati class is an integral part of preoperative airway evaluation. Increasing Mallampati class is known to be associated with greater difficulty with intubation, but some cases of airway difficulty in Mallampati 'class zero' patients have been reported. We undertook this study to evaluate intubation difficulty and to correlate this with indirect laryngoscopy findings in Mallampati class zero patients. The incidence of Mallampati class zero airway in Indian patients and the difficulty in mask ventilation were also evaluated. Prospective double-blind observational study. A tertiary care medical college hospital in Karnataka, India. September 2010 to April 2011. Patients of either sex, 18 years and older, presenting for preanaesthetic examination for elective surgery were evaluated. All patients with Mallampati class zero airway undergoing general anaesthesia with tracheal intubation were included. Exclusion criteria were upper airway disorder, unstable cervical spine, increased risk for aspiration, ischaemic heart disease, increased intracranial pressure, respiratory distress, those unable to sit upright, or infected with hepatitis B, hepatitis C, HIV or pulmonary tuberculosis, or requiring emergency surgery. All underwent indirect laryngoscopy performed by the otorhinolaryngologist and subsequently, direct laryngoscopy performed by the anaesthesiologist. Intubation difficulty was assessed by the Cormack & Lehane grades. Evaluation of intubation difficulty and correlation with indirect laryngoscopy findings in Mallampati class zero patients. Estimation of the incidence of Mallampati class zero airway in Indian patients and the difficulty in mask ventilation. Twenty women and thirteen men, aged 18-65 years, of Mallampati class zero were identified out of 1937 (incidence, 1.7%). The data of 27 patients were analysed. Two patients had 'difficult' mask ventilation. All had a 'predicted easy' airway on indirect laryngoscopy and 'easy' (Cormack & Lehane grade 1 or 2) tracheal intubation. Upon direct laryngoscopy, the epiglottis was described as 'large' in 10 (37%) patients. A Mallampati class zero per se is not associated with difficult airway unless other airway characteristics contribute to the difficulty. Even though the epiglottis may be large and overhanging, it rarely causes airway difficulty in Mallampati class zero airway.

Evaluation of intralesional injection of hyaluronic acid compared with verapamil in Peyronie's disease: preliminary results from a prospective, double-blinded, randomized study.

PubMed

Favilla, V; Russo, G I; Zucchi, A; Siracusa, G; Privitera, S; Cimino, S; Madonia, M; Cai, T; Cavallini, G; Liguori, G; D'Achille, G; Silvani, M; Franco, G; Verze, P; Palmieri, A; Torrisi, B; Mirone, V; Morgia, G

2017-07-01

Several intralesional therapeutic protocols have been proposed for the treatment of Peyronie's disease. Among all, hyaluronic acid (HA) and verapamil have been differently tested. We aimed to evaluate the efficacy of intralesional verapamil (ILVI) compared with intralesional HA in patients with early onset of Peyronie's disease (PD). This is a multi-centre prospective double-arm, randomized, double-blinded study comparing ILVI vs. intralesional HA after 12-weeks. Sexually active men, older than 18 years and affected by the acute phase of PD were eligible for this study. Patients have been double-blinded randomly divided into two groups (1 : 1 ratio): Group A received intralesional treatment with Verapamil (10 mg in 5 mL of normal saline water) weekly for 12 weeks, while group B received intralesional treatment with HA (0.8% highly purified sodium salt HA 16 mg/2 mL) weekly for 12 weeks. The primary efficacy outcome was the change from the baseline to the endpoint (12 weeks after therapy) for the penile curvature (degree). The secondary outcome was the change in the plaque size and in the International Index of erectile Function (IIEF-5) score. The difference between post- and pre-treatment plaque size was -1.36 mm (SD ± 1.27) for Group A and -1.80 mm (SD ± 2.47) for Group B (p-value = NS). IIEF-5 increased of 1.46 points (SD ± 2.18) in Group A and 1.78 (SD ± 2.48) in Group B (p-value ± NS). No difference in penile curvature was observed in Group A, while in Group B the penile curvature decreased of 4.60° (SD ± 5.63) from the baseline (p < 0.001) and vs. Group A. According to PGI-I results, we found significant difference as concerning patient global impression of improvement (PGI-I) (4.0 vs. 2.0; p < 0.05). This prospective, double-arm, randomized, double-blinded study comparing ILVI vs. HA as intralesional therapy showed greater efficacy of HA in terms of penile curvature and PGI-I. © 2017 American Society of Andrology and European Academy of Andrology.

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.

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.

Double-masked, randomized, dose-response study of AR-13324 versus latanoprost in patients with elevated intraocular pressure.

PubMed

Bacharach, Jason; Dubiner, Harvey B; Levy, Brian; Kopczynski, Casey C; Novack, Gary D

2015-02-01

AR-13324 is a small-molecule inhibitor of Rho kinase and a norepinephrine transporter. The objective of this 28-day study was to evaluate the ocular hypotensive efficacy and safety of AR-13324 ophthalmic solution compared with a positive control, latanoprost ophthalmic solution, in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Double-masked, randomized study in 22 private practice ophthalmology clinics. Participants were required to be adults with a diagnosis of OAG or OHT with unmedicated intraocular pressure (IOP) in the range of 22 to 36 mmHg. Patients were randomized to receive AR-13324 ophthalmic solution 0.01%, daily (pm), AR-13324 ophthalmic solution 0.02% daily (pm), or latanoprost 0.005% daily (pm) for 28 days. The primary efficacy endpoint was the mean diurnal IOP across subjects within the treatment group at day 28. Randomized and treated were 224 patients, 213 (95.1%) of whom completed the study. On day 28, mean diurnal IOP was 20.1, 20.0, and 18.7 mmHg in the AR-13324 0.01%, 0.02%, and latanoprost groups, respectively, representing a decrease from unmedicated baseline of 5.5, 5.7, and 6.8 mmHg (P<0.001). The 5.7-mmHg reduction in IOP by AR-13324 0.02% did not meet the criterion for noninferiority to latanoprost. The most frequently reported adverse event was conjunctival/ocular hyperemia, with a combined incidence of 52%, 57%, and 16%, respectively. On day 28 at 08:00 hours, the incidence of mild to moderate hyperemia by biomicroscopy was 18%, 24%, and 11%, respectively. AR-13324 0.02% was less effective than latanoprost by approximately 1 mmHg in patients with unmedicated IOPs of 22 to 35 mmHg. The major safety finding was ocular hyperemia, which was more common for both concentrations of AR-13324 than for latanoprost. Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

A Randomized, Placebo Controlled, Double Masked Phase IB Study Evaluating the Safety and Antiviral Activity of Aprepitant, a Neurokinin-1 Receptor Antagonist in HIV-1 Infected Adults

PubMed Central

Tebas, Pablo; Tuluc, Florin; Barrett, Jeffrey S.; Wagner, Wayne; Kim, Deborah; Zhao, Huaquing; Gonin, René; Korelitz, James; Douglas, Steven D.

2011-01-01

Background Neurokinin-1 receptor (NK1R) antagonists have anti-HIV activity in monocyte-derived macrophages, decrease CCR5 expression and improve natural killer cell function ex vivo. Aprepitant is a NK1R antagonist approved by FDA as an antiemetic. Methods We conducted a phase IB randomized, placebo controlled, double masked study to evaluate the safety, antiviral activity, pharmacokinetics and immune-modulatory effects of aprepitant in HIV-infected adults not receiving antiretroviral therapy, with CD4+ cell count ≥350 cells/mm3 and plasma viral load ≥2,000 copies/ml. Subjects were stratified by viral load (< vs. ≥20,000 copies/ml) and randomized within each stratum to receive aprepitant at 125 mg QD(Low), or 250 mg QD(High), or placebo(PL) for 14 days, and followed for 42 days. Results Thirty subjects were randomized and 27 completed treatment (9, 8, 10 subjects in 125 (Low), 250 (High), and PL groups). 63% were male; 37% white; mean (SD) age 43 (9.3) years. Geometric mean baseline viral load (copies/ml) for Low, High, and PL was 15,709, 33,013, and 19,450, respectively. Mean (95%CI) change in log10 viral load at day 14 for Low, High, and PL was −0.02(−0.24,+0.20), −0.05(−0.21,+0.10), and +0.04(−0.08,+0.16), respectively. The number of subjects with AEs was 4(44.4%), 5(62.5%), and 1(10%) for Low, High, and PL. No Grade 4 AEs occurred. Conclusions Adverse events of aprepitant were more common in the treated groups. At the dose used in this two-week phase IB study, aprepitant showed biological activity, but no significant antiviral activity. Trial Registration ClinicalTrials.gov NCT00428519 PMID:21931661

Triple-Loaded Single-Row Versus Suture-Bridge Double-Row Rotator Cuff Tendon Repair With Platelet-Rich Plasma Fibrin Membrane: A Randomized Controlled Trial.

PubMed

Barber, F Alan

2016-05-01

To compare the structural healing and clinical outcomes of triple-loaded single-row with suture-bridging double-row repairs of full-thickness rotator cuff tendons when both repair constructs are augmented with platelet-rich plasma fibrin membrane. A prospective, randomized, consecutive series of patients diagnosed with full-thickness rotator cuff tears no greater than 3 cm in anteroposterior length were treated with a triple-loaded single-row (20) or suture-bridging double-row (20) repair augmented with platelet-rich plasma fibrin membrane. The primary outcome measure was cuff integrity by magnetic resonance imaging (MRI) at 12 months postoperatively. Secondary clinical outcome measures were American Shoulder and Elbow Surgeons, Rowe, Simple Shoulder Test, Constant, and Single Assessment Numeric Evaluation scores. The mean MRI interval was 12.6 months (range, 12-17 months). A total of 3 of 20 single-row repairs and 3 of 20 double-row repairs (15%) had tears at follow-up MRI. The single-row group had re-tears in 1 single tendon repair and 2 double tendon repairs. All 3 tears failed at the original attachment site (Cho type 1). In the double-row group, re-tears were found in 3 double tendon repairs. All 3 tears failed medial to the medial row near the musculotendinous junction (Cho type 2). All clinical outcome measures were significantly improved from the preoperative level (P < .0001), but there was no statistical difference between groups postoperatively. There is no MRI difference in rotator cuff tendon re-tear rate at 12 months postsurgery between a triple-loaded single-row repair or a suture-bridging double-row repair when both are augmented with platelet-rich plasma fibrin membrane. No difference could be demonstrated between these repairs on clinical outcome scores. I, Prospective randomized study. Copyright © 2016 Arthroscopy Association of North America. All rights reserved.

A randomised controlled trial comparing ProSeal laryngeal mask airway, i-gel and Laryngeal Tube Suction-D under general anaesthesia for elective surgical patients requiring controlled ventilation.

PubMed

Das, Bikramjit; Varshney, Rahul; Mitra, Subhro

2017-12-01

The ProSeal™ laryngeal mask airway (PLMA), i-gel™ and Laryngeal Tube Suction-D (LTS-D™) have previously been evaluated alone or in pair-wise comparisons but differing study designs make it difficult to compare the results. The aim of this study was to compare the clinical performance of these three devices in terms of efficacy and safety in patients receiving mechanical ventilation during elective surgical procedures. This prospective, randomised, double-blind study was conducted on 150 American Society of Anesthesiologists physical status I-II patients, randomly allocated into 3 groups, undergoing elective surgical procedures under general anaesthesia. PLMA, i-gel™ or LTS-D™ appropriate for weight or/and height was inserted. Primary outcome measured was airway sealing pressure. Insertion time, ease of insertion, number of attempts, overall success rate and the incidence of airway trauma and complications were also recorded. Intergroup differences were compared using one-way analysis of variance with post hoc correction for continuous data and Chi-square test for categorical variables. Overall success rate was comparable between the three devices (i-gel™ 100%, LTS-D™ 94%, PLMA 96%). Airway sealing pressure was lower with i-gel™ (23.38 ± 2.06 cm H 2 O) compared to LTS-D™ (26.06 ± 2.11 cm H 2 O) and PLMA (28.5 ± 2.8 cm H 2 O; P < 0.0005). The mean insertion time was significantly more in PLMA (38.77 ± 3.2 s) compared to i-gel™ (27.9 ± 2.53 s) and LTS-D™ (21.66 ± 2.31 s; P < 0.0005). Airway sealing pressure and insertion time were significantly higher in PLMA compared to i-gel™ and LTS-D™.

EVALUATION OF FULL-FIELD ELECTRORETINOGRAM REDUCTIONS AFTER OCRIPLASMIN TREATMENT

PubMed Central

Benz, Matthew S.; Miller, Daniel M.; Antoszyk, Andrew N.; Markoff, Joseph; Kozma, Petra; Meunier, Esmeralda; Sergott, Robert C.

2018-01-01

Purpose: To explore a possible association between full-field electroretinograms with vitreomacular adhesion resolution and best-corrected visual acuity as part of the prospective, randomized, double-masked, sham-controlled Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS) trial studying ocriplasmin. Methods: The ERG substudy enrolled 62 of 220 OASIS subjects (randomized 2:1) and analyzed full-field electroretinograms and their association with both vitreomacular adhesion resolution and best-corrected visual acuity from baseline through Month 24. Electroretinogram reductions were defined as acute full-field electroretinogram reductions in amplitude of ≥40% from baseline occurring at postinjection Day 7 or Day 28. Results: In the ocriplasmin group, 16/40 (40%) subjects developed ERG reductions, compared to 1/21 (4.8%) in the sham group; 13/16 (81.3%) and 1/1 (100%) resolved by study end, respectively. A total of 11/16 (68.8%) ocriplasmin-treated subjects with ERG reductions achieved vitreomacular adhesion resolution, compared to those without (9/24, 37.5%). The ocriplasmin-treated subjects with ERG reductions also gained more letters on average (11.3 vs. 9.3 letters) from baseline and had a difference of 6.7 letters in mean best-corrected visual acuity by study end compared to those without ERG reductions. Conclusion: Ocriplasmin-treated subjects with ERG reductions had a higher rate of vitreomacular adhesion resolution and showed better visual improvement than their counterparts without ERG reductions or sham subjects by study end. PMID:28198785

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.

Cryptosystem based on two-step phase-shifting interferometry and the RSA public-key encryption algorithm

NASA Astrophysics Data System (ADS)

Meng, X. F.; Peng, X.; Cai, L. Z.; Li, A. M.; Gao, Z.; Wang, Y. R.

2009-08-01

A hybrid cryptosystem is proposed, in which one image is encrypted to two interferograms with the aid of double random-phase encoding (DRPE) and two-step phase-shifting interferometry (2-PSI), then three pairs of public-private keys are utilized to encode and decode the session keys (geometrical parameters, the second random-phase mask) and interferograms. In the stage of decryption, the ciphered image can be decrypted by wavefront reconstruction, inverse Fresnel diffraction, and real amplitude normalization. This approach can successfully solve the problem of key management and dispatch, resulting in increased security strength. The feasibility of the proposed cryptosystem and its robustness against some types of attack are verified and analyzed by computer simulations.

A randomized, double-blind, 24-week study of escitalopram (10 mg/day) versus citalopram (20 mg/day) in primary care patients with major depressive disorder.

PubMed

Colonna, Lucien; Andersen, Henning Friis; Reines, Elin Heldbo

2005-10-01

A randomized, double-blind, 24-week-fixed-dose study comparing the efficacy and safety of escitalopram to that of citalopram was safety was conducted in primary care patients with moderate to severe major depressive disorder (MDD). This was a randomized, double-blind, 24-week fixeddose study. Patients were randomly assigned to treatment with escitalopram 10 mg/day (n = 175) or citalopram 20 mg/day (n = 182). Clinical response was evaluated using the Montgomery-Asberg Depression Rating Scale (MADRS) and Clinical Global Impression-Severity (CGI-S) scale. The prospectively defined primary parameter of antidepressant efficacy was the change from baseline in the mean MADRS total score during the 24 weeks of double-blind treatment, using a repeated measures analysis of variance to compare the treatment groups over all assessment points simultaneously. Based on the primary parameter, escitalopram was at least as efficacious as citalopram. Based on the prospectively defined secondary parameter, mean change from baseline in the CGI-S score, escitalopram was statistically significantly superior to citalopram at Week 24. The importance of long-term treatment could be demonstrated, in that more than half (55% and 51%) of the patients who had not responded by Week 8 achieved remission by Week 24. Both escitalopram and citalopram were safe and well tolerated in acute and long-term treatment, and the overall adverse event profiles for the two drugs were similar. For the intent-to-treat population, there were statistically significantly fewer withdrawals in the escitalopram group than in the citalopram group, particularly after Week 8. Patients with MDD responded well to long-term treatment with either escitalopram or citalopram. This study demonstrated the importance of extending treatment of depression beyond 8 weeks.

Basic life support trained nurses ventilate more efficiently with laryngeal mask supreme than with facemask or laryngeal tube suction-disposable--a prospective, randomized clinical trial.

PubMed

Gruber, Elisabeth; Oberhammer, Rosmarie; Balkenhol, Karla; Strapazzon, Giacomo; Procter, Emily; Brugger, Hermann; Falk, Markus; Paal, Peter

2014-04-01

In some emergency situations resuscitation and ventilation may have to be performed by basic life support trained personnel, especially in rural areas where arrival of advanced life support teams can be delayed. The use of advanced airway devices such as endotracheal intubation has been deemphasized for basically-trained personnel, but it is unclear whether supraglottic airway devices are advisable over traditional mask-ventilation. In this prospective, randomized clinical single-centre trial we compared airway management and ventilation performed by nurses using facemask, laryngeal mask Supreme (LMA-S) and laryngeal tube suction-disposable (LTS-D). Basic life support trained nurses (n=20) received one-hour practical training with each device. ASA 1-2 patients scheduled for elective surgery were included (n=150). After induction of anaesthesia and neuromuscular block nurses had two 90-second attempts to manage the airway and ventilate the patient with volume-controlled ventilation. Ventilation failed in 34% of patients with facemask, 2% with LMA-S and 22% with LTS-D (P<0.001). In patients who could be ventilated successfully mean tidal volume was 240±210 ml with facemask, 470±120 ml with LMA-S and 470±140 ml with LTS-D (P<0.001). Leak pressure was lower with LMA-S (23.3±10.8 cm H2O, 95% CI 20.2-26.4) than with LTS-D (28.9±13.9 cm·H2O, 95% CI 24.4-33.4; P=0.047). After one hour of introductory training, nurses were able to use LMA-S more effectively than facemask and LTS-D. High ventilation failure rates with facemask and LTS-D may indicate that additional training is required to perform airway management adequately with these devices. High-level trials are needed to confirm these results in cardiac arrest patients. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Randomized Double Masked Trial of Zhi Byed 11, a Tibetan Traditional Medicine, Versus Misoprostol to Prevent Postpartum Hemorrhage in Lhasa, Tibet

PubMed Central

Miller, Suellen; Tudor, Carrie; Thorsten, Vanessa; Nyima; Kalyang; Sonam; Lhakpen; Droyoung; Quzong, Karma; Dekyi, Tsering; Hartwell, Ty; Wright, Linda L.; Varner, Michael W.

2009-01-01

The objective of this study was to compare a Tibetan traditional medicine (the uterotonic Zhi Byed 11 [ZB11]) to oral misoprostol for prophylaxis of postpartum hemorrhage (PPH). We conducted a double-blind randomized controlled trial at three hospitals in Lhasa, Tibet, People’s Republic of China. Women (N = 967) were randomized to either ZB11 or misoprostol groups. Postpartum blood loss was measured in a calibrated blood collection drape. The primary combined outcome was incidence of PPH, defined as measured blood loss (MBL) ≥ 500 mL, administration of open label uterotonics, or maternal death. We found that the rate of the combined outcome was lower among the misoprostol group (16.1% versus 21.8% for ZB11; P = .02). Frequency of PPH was lower with misoprostol (12.4% versus 17.4%; P = .02). There were no significant differences in MBL > 1000 mL or mean or median MBL. Fever was significantly more common in the misoprostol group (P = .03). The rate of combined outcome was significantly lower among women receiving misoprostol. However, other indices of obstetric hemorrhage were not significantly different. PMID:19249659

Timolol LA: a double-masked, active-controlled, randomized, crossover, comfort, ocular safety, and systemic bioavailability study in healthy volunteers.

PubMed

Mundorf, Thomas K; Ogawa, Takahiro; Inui, Noritsugu; Naka, Hiroaki; Novack, Gary D; Crockett, R Stephens

2005-03-01

A new formulation of timolol with sorbic acid, timolol-LA (TLA) (Istaloldagger), has been developed which increases its ocular bioavailability. In the present study, we desired to evaluate the ocular comfort and systemic bioavailability of TLA in healthy volunteers in comparison to standard timolol maleate ophthalmic solution (TIM). This study was a randomized, double-masked, active-controlled, crossover evaluation of 0.5% TLA and 0.5% TIM, bid, in 12 normal healthy volunteers. Visits were at Days 0, 1, 2, 4 and 8 in each period, and there was a minimum 7 day interperiod washout. At all three post-dosing evaluation times (Day 1: Peak, Day 8: Trough, and Day 8: Peak), the 95% confidence interval for the difference between TLA and TIM was not more than 0.37 ng/mL. After administration of TLA, there was a greater incidence of burning/stinging and tearing, but not foreign body sensation, relative to TIM. In general, most symptoms were mild in intensity, and no subject discontinued treatment due to ocular discomfort. Both treatments decreased IOP to a similar level. TLA was relatively comfortable, with a safety profile consistent with further clinical development, and, with bid dosing (exaggerated [2X] that anticipated for clinical use), had a systemic bioavailability similar to that of TIM 0.5%, bid. The incidence of burning and stinging was higher with TLA than with TIM, although reports were mild in severity and did not result in any patient discontin uations. Although the results are of interest, further evaluation in a larger trial may be warranted.

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 efficacy and resource utilization of remifentanil and fentanyl in fast-track coronary artery bypass graft surgery: a prospective randomized, double-blinded controlled, multi-center trial.

PubMed

Cheng, D C; Newman, M F; Duke, P; Wong, D T; Finegan, B; Howie, M; Fitch, J; Bowdle, T A; Hogue, C; Hillel, Z; Pierce, E; Bukenya, D

2001-05-01

We compared (a) the perioperative complications; (b) times to eligibility for, and actual time of the following: extubation, less intense monitoring, intensive care unit (ICU), and hospital discharge; and (c) resource utilization of nursing ratio for patients receiving either a typical fentanyl/isoflurane/propofol regimen or a remifentanil/isoflurane/propofol regimen for fast-track cardiac anesthesia in 304 adults by using a prospective randomized, double-blinded, double-dummy trial. There were no differences in demographic data, or perioperative mortality and morbidity between the two study groups. The mini-mental status examination at postoperative Days 1 to 3 were similar between the two groups. The eligible and actual times for extubation, less intense monitoring, ICU discharge, and hospital discharge were not significantly different. Further analyses revealed no differences in times for extubation and resource utilization after stratification by preoperative risk scores, age, and country. The nurse/patient ratio was similar between the remifentanil/isoflurane/propofol and fentanyl/isoflu-rane/propofol groups during the initial ICU phase and less intense monitoring phase. Increasing preoperative risk scores and older age (>70 yr) were associated with longer times until extubation (eligible), ICU discharge (eligible and actual), and hospital discharge (eligible and actual). Times until extubation (eligible and actual) and less intense monitoring (eligible) were significantly shorter in Canadian patients than United States' patients. However, there was no difference in hospital length of stay in Canadian and United States' patients. We conclude that both anesthesia techniques permit early and similar times until tracheal extubation, less intense monitoring, ICU and hospital discharge, and reduced resource utilization after coronary artery bypass graft surgery. An ultra-short opioid technique was compared with a standard fast-track small-dose opioid technique in coronary artery bypass graft patients in a prospective randomized, double-blinded controlled study. The postoperative recovery and resource utilization, including stratification of preoperative risk score, age, and country, were analyzed.

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.

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.

Effects of SofZia-preserved travoprost and benzalkonium chloride-preserved latanoprost on the ocular surface -- a multicentre randomized single-masked study.

PubMed

Aihara, Makoto; Oshima, Hiromi; Araie, Makoto

2013-02-01

To assess the effect of SofZia-preserved travoprost on ocular surface conditions in comparison with benzalkonium chloride (BAK)-preserved latanoprost. A prospective randomized multicentre single-masked comparative study. Patients with open-angle glaucoma or ocular hypertension who had been treated with BAK-preserved latanoprost 0.005% (Xalatan(®) ) monotherapy for at least 3 months. Patients were enrolled at 23 facilities. Patients were randomly divided into the X-X group, continuous use of Xalatan(®) , or the X-T group, switching from Xalatan(®) to SofZia-preserved travoprost 0.004% (TravatanZ(®) ), and followed for 3 months. The superficial punctate keratopathy (SPK), conjunctival epitheliopathy, hyperaemia, tear break-up time (TBUT) and intraocular pressure (IOP) were examined for each patient in a masked manner. Changes in the frequency of keratoconjunctival epitheliopathy were evaluated 3 months after study initiation. Intra- and intergroup comparisons of changes in SPK, conjunctival epitheliopathy, hyperaemia, TBUT and IOP were also carried out. Two hundred twenty patients participated and 215 completed the 3-month study. The frequency of keratoconjunctival epitheliopathy significantly decreased in the X-T group (p = 0.036) and the intergroup difference was also significant (p = 0.001). SPK scores and TBUT were significantly improved in the X-T group (p = 0.034, 0.049), also with significant intergroup differences in the cornea excluding the inferior area and TBUT. There were no significant intergroup differences in changes of the hyperaemia scores and the IOP reduction. Switching to SofZia-preserved travoprost after BAK-preserved latanoprost resulted in a lower incidence of keratoconjunctival epitheliopathy, especially in the cornea, with no clinically relevant changes in hyperaemia and IOP. © 2012 The Authors. Acta Ophthalmologica © 2012 Acta Ophthalmologica Scandinavica Foundation.

Racemic versus l-epinephrine aerosol in the treatment of postextubation laryngeal edema: results from a prospective, randomized, double-blind study.

PubMed

Nutman, J; Brooks, L J; Deakins, K M; Baldesare, K K; Witte, M K; Reed, M D

1994-10-01

To determine whether any advantage exists using racemic epinephrine instead of the more potent and less expensive levo(1)-epinephrine in the treatment of postextubation laryngeal edema. Prospective, double-blind, randomized study. Pediatric intensive care unit in a university teaching hospital. Twenty-eight patients with stridor during the immediate postextubation period. After extubation, patients demonstrating clinically important stridor were randomized in a double-blind fashion to receive an aerosol containing either 2.25% racemic or 1% l-epinephrine. Heart rate, respiratory rate, blood pressure, and stridor score were determined at 20, 40, and 60 mins and 4 and 8 hrs after the initial aerosol administration. Patients in both groups demonstrated significant (p < .01) reductions in stridor score after aerosol administration. No significant differences were observed between treatment groups in improvement in stridor score or the number of subsequent aerosols required. Respiratory rate decreased significantly 40 and 60 mins after l-epinephrine but not after racemic epinephrine. No significant change in heart rate or blood pressure occurred after aerosol administration in either group. These data suggest that aerosolized l-epinephrine is as effective as aerosolized racemic epinephrine in the treatment of postextubation laryngeal edema without additional adverse side effects. When dosed appropriately, l-epinephrine is a less expensive and more widely available alternative to racemic epinephrine for the treatment of postextubation laryngeal edema.

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.

Comparison of Olive Tipped and Conventional Steven's Cannula for Sub-Tenon Ophthalmic Anesthesia

PubMed Central

Al-Motowa, Saeed; Ahmad, Nauman; Khandekar, Rajiv; Zahoor, Abdul

2016-01-01

PURPOSE: To compare the efficacy of the olive tipped (OT) cannula to the conventional Steven's cannula for sub-Tenon block (STB) before cataract surgery. METHODS: This prospective, randomized, double-masked compared STB delivered in cataract surgery patients with an OT cannula or a conventional Steven's cannula (ST). Outcome variables included the akinesia score and lid movement scores at 5 and 10 min. The patient perception of pain during delivery of the STB and surgery were also compared between groups. Surgeon satisfaction with anesthesia was compared between groups. P <0.05 was statistically significant. RESULTS: There were sixty patients in each group. The age between groups was not statistically different (P = 0.4). The body mass index was higher in the ST group compared to the OT group (P < 0.001). The akinesia score at 5 and 10 min did not differ between groups (P = 0.07 and P = 0.6, respectively). The patient perception of pain during STB and surgery were similar between groups (P = 0.1 and P = 0.06, respectively). There were six patients with mild chemosis and redness in the OT group and 15 patients in the ST group. CONCLUSION: An OT cannula is equally effective as the conventional Steven's cannula for delivering STB anesthesia before cataract surgery. PMID:27994394

Comparison of Olive Tipped and Conventional Steven's Cannula for Sub-Tenon Ophthalmic Anesthesia.

PubMed

Al-Motowa, Saeed; Ahmad, Nauman; Khandekar, Rajiv; Zahoor, Abdul

2016-01-01

To compare the efficacy of the olive tipped (OT) cannula to the conventional Steven's cannula for sub-Tenon block (STB) before cataract surgery. This prospective, randomized, double-masked compared STB delivered in cataract surgery patients with an OT cannula or a conventional Steven's cannula (ST). Outcome variables included the akinesia score and lid movement scores at 5 and 10 min. The patient perception of pain during delivery of the STB and surgery were also compared between groups. Surgeon satisfaction with anesthesia was compared between groups. P <0.05 was statistically significant. There were sixty patients in each group. The age between groups was not statistically different ( P = 0.4). The body mass index was higher in the ST group compared to the OT group ( P < 0.001). The akinesia score at 5 and 10 min did not differ between groups ( P = 0.07 and P = 0.6, respectively). The patient perception of pain during STB and surgery were similar between groups ( P = 0.1 and P = 0.06, respectively). There were six patients with mild chemosis and redness in the OT group and 15 patients in the ST group. An OT cannula is equally effective as the conventional Steven's cannula for delivering STB anesthesia before cataract surgery.

NOTE: Calculating diffraction patterns

NASA Astrophysics Data System (ADS)

Rioux, Frank

2003-05-01

Following Marcella's approach to the double-slit experiment (Marcella T V 2002 Eur. J. Phys. 23 615-21), diffraction patterns for two-dimensional masks are calculated by Fourier transform of the Mask geometry into momentum space.

Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term non-steroidal anti-inflammatory drug (NSAID) therapy: results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial.

PubMed

Sugano, Kentaro; Kontani, Teiji; Katsuo, Shinichi; Takei, Yoshinori; Sakaki, Nobuhiro; Ashida, Kiyoshi; Mizokami, Yuji; Asaka, Masahiro; Matsui, Shigeyuki; Kanto, Tatsuya; Soen, Satoshi; Takeuchi, Tsutomu; Hiraishi, Hideyuki; Hiramatsu, Naoki

2012-05-01

Low-dose lansoprazole has not been intensively evaluated for its efficacy in the prevention of recurrent gastric or duodenal ulcers in patients receiving long-term non-steroidal anti-inflammatory drug (NSAID) therapy for pain relief in such diseases as rheumatoid arthritis, osteoarthritis, and low back pain. This multi-center, prospective, double-blind, randomized, active-controlled study involving 99 sites in Japan was designed to compare the efficacy of lansoprazole (15 mg daily) with gefarnate (50 mg twice daily). Patients with a history of gastric or duodenal ulcers who required long-term NSAID therapy were randomized to receive lansoprazole 15 mg daily (n = 185) or gefarnate 50 mg twice daily (n = 181) and followed up for 12 months or longer prospectively. The cumulative incidence of gastric or duodenal ulcer at days 91, 181, and 361 from the start of the study was calculated by the Kaplan-Meier method as 3.3, 5.9, and 12.7%, respectively, in the lansoprazole group versus 18.7, 28.5, and 36.9%, respectively, in the gefarnate group. The risk for ulcer development was significantly (log-rank test, P < 0.0001) lower in the lansoprazole group than in the gefarnate group, with the hazard ratio being 0.2510 (95% CI 0.1400-0.4499). A long-term follow-up study showed an acceptable safety profile for low-dose lansoprazole therapy, with diarrhea as the most frequent adverse event. Lansoprazole was superior to gefarnate in reducing the risk of gastric or duodenal ulcer recurrence in patients with a definite history of gastric or duodenal ulcers who required long-term NSAID therapy.

Physical activity after retinal detachment surgery.

PubMed

Bovino, J A; Marcus, D F

1984-08-15

A prospective, randomized, masked clinical trial to assess the value of limited physical activity after scleral buckling surgery included 108 consecutive patients with rhegmatogenous retinal detachment randomly divided into two groups. The first group was encouraged to resume full physical activity immediately after hospital discharge. In the second group, bending, lifting, straining at stool, driving, sexual activity, lawnmowing, gardening, athletics, and returning to work were strictly forbidden for six weeks. A thorough evaluation of patient compliance was performed after six weeks. Six months after surgery the rates of reoperation and final reattachment percentages of the active and inactive groups showed no statistically significant difference (P greater than .05). Final visual acuity, measured one year after surgery, also identified no statistically significant difference between the groups (P greater than .05).

The Respiratory Protection Effectiveness Clinical Trial (ResPECT): a cluster-randomized comparison of respirator and medical mask effectiveness against respiratory infections in healthcare personnel.

PubMed

Radonovich, Lewis J; Bessesen, Mary T; Cummings, Derek A; Eagan, Aaron; Gaydos, Charlotte; Gibert, Cynthia; Gorse, Geoffrey J; Nyquist, Ann-Christine; Reich, Nicholas G; Rodrigues-Barradas, Maria; Savor-Price, Connie; Shaffer, Ronald E; Simberkoff, Michael S; Perl, Trish M

2016-06-02

Although N95 filtering facepiece respirators and medical masks are commonly used for protection against respiratory infections in healthcare settings, more clinical evidence is needed to understand the optimal settings and exposure circumstances for healthcare personnel to use these devices. A lack of clinically germane research has led to equivocal, and occasionally conflicting, healthcare respiratory protection recommendations from public health organizations, professional societies, and experts. The Respiratory Protection Effectiveness Clinical Trial (ResPECT) is a prospective comparison of respiratory protective equipment to be conducted at multiple U.S. study sites. Healthcare personnel who work in outpatient settings will be cluster-randomized to wear N95 respirators or medical masks for protection against infections during respiratory virus season. Outcome measures will include laboratory-confirmed viral respiratory infections, acute respiratory illness, and influenza-like illness. Participant exposures to patients, coworkers, and others with symptoms and signs of respiratory infection, both within and beyond the workplace, will be recorded in daily diaries. Adherence to study protocols will be monitored by the study team. ResPECT is designed to better understand the extent to which N95s and MMs reduce clinical illness among healthcare personnel. A fully successful study would produce clinically relevant results that help clinician-leaders make reasoned decisions about protection of healthcare personnel against occupationally acquired respiratory infections and prevention of spread within healthcare systems. The trial is registered at clinicaltrials.gov, number NCT01249625 (11/29/2010).

Review and Analysis of Publication Trends over Three Decades in Three High Impact Medicine Journals.

PubMed

Ivanov, Alexander; Kaczkowska, Beata A; Khan, Saadat A; Ho, Jean; Tavakol, Morteza; Prasad, Ashok; Bhumireddy, Geetha; Beall, Allan F; Klem, Igor; Mehta, Parag; Briggs, William M; Sacchi, Terrence J; Heitner, John F

2017-01-01

Over the past three decades, industry sponsored research expanded in the United States. Financial incentives can lead to potential conflicts of interest (COI) resulting in underreporting of negative study results. We hypothesized that over the three decades, there would be an increase in: a) reporting of conflict of interest and source of funding; b) percentage of randomized control trials c) number of patients per study and d) industry funding. Original articles published in three calendar years (1988, 1998, and 2008) in The Lancet, New England Journal of Medicine and Journal of American Medical Association were collected. Studies were reviewed and investigational design categorized as prospective and retrospective clinical trials. Prospective trials were categorized into randomized or non-randomized and single-center or multi-center trials. Retrospective trials were categorized as registries, meta-analyses and other studies, mostly comprising of case reports or series. Study outcomes were categorized as positive or negative depending on whether the pre-specified hypothesis was met. Financial disclosures were researched for financial relationships and profit status, and accordingly categorized as government, non-profit or industry sponsored. Studies were assessed for reporting COI. 1,671 original articles were included in this analysis. Total number of published studies decreased by 17% from 1988 to 2008. Over 20 year period, the proportion of prospective randomized trials increased from 22 to 46% (p < 0.0001); whereas the proportion of prospective non-randomized trials decreased from 59% to 27% (p < 0.001). There was an increase in the percentage of prospective randomized multi-center trials from 11% to 41% (p < 0.001). Conversely, there was a reduction in non-randomized single-center trials from 47% to 10% (p < 0.001). Proportion of government funded studies remained constant, whereas industry funded studies more than doubled (17% to 40%; p < 0.0001). The number of studies with negative results more than doubled (10% to 22%; p<0.0001). While lack of funding disclosure decreased from 35% to 7%, COI reporting increased from 2% to 84% (p < 0.0001). Improved reporting of COI, clarity in financial sponsorship, increased publication of negative results in the setting of larger and better designed clinical trials represents a positive step forward in the scientific publications, despite the higher percentage of industry funded studies.

A multicentre, double-masked, randomized, controlled trial assessing the effect of oral supplementation of omega-3 and omega-6 fatty acids on a conjunctival inflammatory marker in dry eye patients.

PubMed

Brignole-Baudouin, Françoise; Baudouin, Christophe; Aragona, Pasquale; Rolando, Maurizio; Labetoulle, Marc; Pisella, Pierre Jean; Barabino, Stefano; Siou-Mermet, Raphaele; Creuzot-Garcher, Catherine

2011-11-01

To determine whether oral supplementation with omega-3 and omega-6 fatty acids can reduce conjunctival epithelium expression of the inflammatory marker human leucocyte antigen-DR (HLA-DR) in patients with dry eye syndrome (DES). This 3-month, double-masked, parallel-group, controlled study was conducted in nine centres, in France and Italy. Eligible adult patients with mild to moderate DES were randomized to receive a placebo containing medium-chain triglycerides or treatment supplement containing omega-3 and omega-6 fatty acids, vitamins and zinc. Treatment regimen was three capsules daily. Impression cytology (IC) was performed at baseline and at month 3 to assess the percentage of cells expressing HLA-DR and to evaluate fluorescence intensity, an alternate measure of HLA-DR. Dry eye symptoms and objective signs were also evaluated. Analyses were performed on the full analysis set (FAS) and per-protocol set (PPS). In total, 138 patients were randomized; 121 patients with available IC were included in the FAS, and of these, 106 patients had no major protocol deviations (PPS). In the PPS, there was a significant reduction in the percentage of HLA-DR-positive cells in the fatty acids group (p = 0.021). Expression of HLA-DR as measured by fluorescence intensity quantification was also significantly reduced in the fatty acids group [FAS (p = 0.041); PPS (p = 0.017)]. No significant difference was found for the signs and symptoms, but there was a tendency for improvement in patients receiving the fatty acids treatment. This study demonstrates that supplementation with omega-3 and omega-6 fatty acids can reduce expression of HLA-DR conjunctival inflammatory marker and may help improve DES symptoms. © 2011 The Authors. Acta Ophthalmologica © 2011 Acta Ophthalmologica Scandinavica Foundation.

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.

Evaluation of the muscle relaxant cyclobenzaprine after third-molar extraction.

PubMed

de Santana Santos, Thiago; Calazans, Anna Carla Maranhão; Martins-Filho, Paulo Ricardo Saquete; Silva, Luiz Carlos Ferreira da; de Oliveira E Silva, Emanuel Dias; Gomes, Ana Claudia Amorim

2011-10-01

Pain, swelling and trismus are undesirable effects of extraction of impacted mandibular third molars. The authors conducted a study to evaluate the effectiveness of the muscle relaxant cyclobenzaprine when used as a supplement to cryotherapeutic, antibiotic and steroidal anti-inflammatory treatment with the aim of reducing undesirable consequences after third-molar extraction. The authors conducted a prospective, randomized, double-masked, placebo-controlled clinical trial involving 50 participants aged 18 to 29 years randomly assigned to receive cyclobenzaprine or the placebo. The authors used a split-mouth design, so each participant acted as his or her own control. For each participant, the authors extracted one impacted mandibular third molar on each side of the mouth at different times. Participants received 10 milligrams of cyclobenzaprine or a placebo once per day the day before surgery, the day of surgery and the first day after surgery. The authors assessed the participants' postoperative pain by means of a visual analog scale at four, six, eight, 12, 24 and 48 hours. They measured the participants' swelling and maximal interincisor distance at 48 hours and seven days. The authors assessed both sides of each participant's mouth for differences in pain, swelling and trismus. They found no statistically significant differences between sides of the mouth regarding these three variables. The results of this trial indicate that the influence of cyclobenzaprine over pain, swelling and trismus does not justify prescribing additional medication for patients undergoing third-molar extraction. The muscle relaxant cyclobenzaprine was ineffective in reducing pain, swelling and trismus after third-molar extraction.

Fibrin adhesive is better than sutures in pterygium surgery.

PubMed

Ratnalingam, Vanitha; Eu, Andrew Lim Keat; Ng, Gim Leong; Taharin, Rohana; John, Elizabeth

2010-05-01

To evaluate the recurrence rate, surgical time, and postoperative pain between conjunctival autografting with sutures and with fibrin adhesive in pterygium surgery. A prospective, randomized, double-blind, clinical trial on the benefits of using fibrin adhesive in place of sutures in pterygium surgery. One hundred seventy-five eyes with primary pterygium were randomized to undergo pterygium surgery with conjunctival autograft transplantation using either fibrin adhesive or sutures. One hundred thirty-seven eyes of 113 patients that were operated on by a single surgeon (V.R.) completed the 1-year follow-up. Sixty-eight eyes were operated with fibrin adhesive and 69 eyes with sutures. Patients were followed up at 1 day, 1 week, 1 month, 6 months, and 1 year after surgery. Pterygium recurrence and postoperative pain was graded by an independent observer (A.L.) masked to the method of treatment. Surgical time was measured with a stopwatch. All patients were followed up for 1 year. There were 3 recurrences (4.41%) in the fibrin adhesive group and 11 recurrences (15.9%) in the suture group. The mean duration required to complete surgery in the fibrin adhesive group was 16.93 +/- 2.85 minutes, whereas that of the suture group was 29.84 +/- 5.65 minutes, which was statistically significant (P < 0.001). The immediate postoperative pain score and week 1 postoperative pain score were significantly lower in the fibrin adhesive group (P < 0.05). No major complications were observed in either group. The use of fibrin adhesive in primary pterygium surgery with conjunctival autografts reduces the recurrence rate, surgical time, and postoperative pain when compared with sutures.

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.

Corneal wound healing after superficial foreign body injury: vitamin A and dexpanthenol versus a calf blood extract. A randomized double-blind study.

PubMed

Egger, S F; Huber-Spitzy, V; Alzner, E; Scholda, C; Vecsei, V P

1999-01-01

A prospective randomized double-blind clinical study was performed to investigate corneal wound healing after treatment either with an eye gel containing calf blood extract or an eye ointment containing vitamin A and dexpanthenol. A total of 54 outpatients were included in this study, all treated for corneal foreign body injury. The size of the corneal lesions was measured by planimetry on days 0, 1, and on the following days until complete epithelial healing occurred. Results showed the calf blood extract eye gel to be statistically more effective in promoting corneal wound healing, especially in patients with wound areas larger than 6 mm(2).

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.

Are there specific benefits of amoxicillin plus metronidazole in Aggregatibacter actinomycetemcomitans-associated periodontitis? Double-masked, randomized clinical trial of efficacy and safety.

PubMed

Mombelli, Andrea; Cionca, Norbert; Almaghlouth, Adnan; Décaillet, Fabien; Courvoisier, Delphine S; Giannopoulou, Catherine

2013-06-01

It has been suggested that prescription of amoxicillin plus metronidazole in the context of periodontal therapy should be limited to patients with specific microbiologic profiles, especially those testing positive for Aggregatibacter actinomycetemcomitans. The main purpose of this analysis is to determine if patients positive for A. actinomycetemcomitans with moderate to advanced periodontitis benefit specifically from amoxicillin plus metronidazole given as an adjunct to full-mouth scaling and root planing. This is a double-masked, placebo-controlled, randomized longitudinal study including 41 participants who were positive for A. actinomycetemcomitans and 41 participants who were negative for A. actinomycetemcomitans. All 82 patients received full-mouth periodontal debridement performed within 48 hours. Patients then received either systemic antibiotics (375 mg amoxicillin and 500 mg metronidazole, three times daily) or placebo for 7 days. The primary outcome variable was persistence of sites with a probing depth (PD) >4 mm and bleeding on probing (BOP) at the 3-month reevaluation. Using multilevel logistic regression, the effect of the antibiotics was analyzed according to the following factors (interaction effect): A. actinomycetemcomitans-positive or -negative at baseline, sex, age, smoking, tooth being a molar, and interdental location. At reevaluation, participants in the test group had significantly fewer sites with a persisting PD >4 mm and BOP than control patients (P <0.01). Being A. actinomycetemcomitans-positive or -negative did not change the effect of the antibiotics. Patients benefited from the antibiotics irrespective of sex, age, or smoking status. Molars benefited significantly more from the antibiotics than non-molars (P for interaction effect = 0.03). Patients who were positive for A. actinomycetemcomitans had no specific benefit from amoxicillin plus metronidazole. Sites on molars benefited significantly more from the antibiotics than non-molar sites.

A Prospective, Randomized, Double-blind, Split-face Clinical Trial Comparing the Efficacy of Two Topical Human Growth Factors for the Rejuvenation of the Aging Face

PubMed Central

Goldman, Mitchel P.

2017-01-01

Background: Cosmeceutical products represent an increasingly important therapeutic option for anti-aging and rejuvenation, either used alone or in combination with dermatologic surgical procedures. Among this group of products, topical growth factors have demonstrated efficacy in randomized, controlled clinical trials. However, comparisons between different products remain uncommon. Objective: The objective of this randomized, double-blind, split-face clinical trial was to compare two different topical growth factor formulations derived from either human fibroblasts or human adipose tissue derived mesenchymal stem cells. Methods: This was an institutional review board-approved, randomized, double-blind, split-face clinical trial involving 20 healthy subjects with moderate-to-severe facial wrinkling secondary to photodamage. One half of the face was randomized to receive topical human fibroblast growth factors and the other topical human mesenchymal stem cell growth factors. Treatment was continued for three months, and evaluations were performed in a double-blind fashion. Results: Both growth factor formulations achieved significant improvement in facial wrinkling. Blinded investigator and subject evaluations did not detect any significant differences between the two formulations in terms of efficacy, safety, or tolerability. Conclusion: Both human fibroblast growth factors and human mesenchymal stem cell growth factors are effective at facial rejuvenation. Topical growth factors represent a useful therapeutic modality. PMID:28670356

A Prospective, Randomized, Double-blind, Split-face Clinical Trial Comparing the Efficacy of Two Topical Human Growth Factors for the Rejuvenation of the Aging Face.

PubMed

Wu, Douglas C; Goldman, Mitchel P

2017-05-01

Background: Cosmeceutical products represent an increasingly important therapeutic option for anti-aging and rejuvenation, either used alone or in combination with dermatologic surgical procedures. Among this group of products, topical growth factors have demonstrated efficacy in randomized, controlled clinical trials. However, comparisons between different products remain uncommon. Objective: The objective of this randomized, double-blind, split-face clinical trial was to compare two different topical growth factor formulations derived from either human fibroblasts or human adipose tissue derived mesenchymal stem cells. Methods: This was an institutional review board-approved, randomized, double-blind, split-face clinical trial involving 20 healthy subjects with moderate-to-severe facial wrinkling secondary to photodamage. One half of the face was randomized to receive topical human fibroblast growth factors and the other topical human mesenchymal stem cell growth factors. Treatment was continued for three months, and evaluations were performed in a double-blind fashion. Results: Both growth factor formulations achieved significant improvement in facial wrinkling. Blinded investigator and subject evaluations did not detect any significant differences between the two formulations in terms of efficacy, safety, or tolerability. Conclusion: Both human fibroblast growth factors and human mesenchymal stem cell growth factors are effective at facial rejuvenation. Topical growth factors represent a useful therapeutic modality.

Process variation challenges and resolution in the negative-tone develop double patterning for 20nm and below technology node

NASA Astrophysics Data System (ADS)

Mehta, Sohan S.; Ganta, Lakshmi K.; Chauhan, Vikrant; Wu, Yixu; Singh, Sunil; Ann, Chia; Subramany, Lokesh; Higgins, Craig; Erenturk, Burcin; Srivastava, Ravi; Singh, Paramjit; Koh, Hui Peng; Cho, David

2015-03-01

Immersion based 20nm technology node and below becoming very challenging to chip designers, process and integration due to multiple patterning to integrate one design layer . Negative tone development (NTD) processes have been well accepted by industry experts for enabling technologies 20 nm and below. 193i double patterning is the technology solution for pitch down to 80 nm. This imposes tight control in critical dimension(CD) variation in double patterning where design patterns are decomposed in two different masks such as in litho-etch-litho etch (LELE). CD bimodality has been widely studied in LELE double patterning. A portion of CD tolerance budget is significantly consumed by variations in CD in double patterning. The objective of this work is to study the process variation challenges and resolution in the Negative Tone Develop Process for 20 nm and Below Technology Node. This paper describes the effect of dose slope on CD variation in negative tone develop LELE process. This effect becomes even more challenging with standalone NTD developer process due to q-time driven CD variation. We studied impact of different stacks with combination of binary and attenuated phase shift mask and estimated dose slope contribution individually from stack and mask type. Mask 3D simulation was carried out to understand theoretical aspect. In order to meet the minimum insulator requirement for the worst case on wafer the overlay and critical dimension uniformity (CDU) budget margins have slimmed. Besides the litho process and tool control using enhanced metrology feedback, the variation control has other dependencies too. Color balancing between the two masks in LELE is helpful in countering effects such as iso-dense bias, and pattern shifting. Dummy insertion and the improved decomposition techniques [2] using multiple lower priority constraints can help to a great extent. Innovative color aware routing techniques [3] can also help with achieving more uniform density and color balanced layouts.

Model-based assist feature insertion for sub-40nm memory device

NASA Astrophysics Data System (ADS)

Suh, Sungsoo; Lee, Suk-joo; Choi, Seong-woon; Lee, Sung-Woo; Park, Chan-hoon

2009-04-01

Many issues need to be resolved for a production-worthy model based assist feature insertion flow for single and double exposure patterning process to extend low k1 process at 193 nm immersion technology. Model based assist feature insertion is not trivial to implement either for single and double exposure patterning compared to rule based methods. As shown in Fig. 1, pixel based mask inversion technology in itself has difficulties in mask writing and inspection although it presents as one of key technology to extend single exposure for contact layer. Thus far, inversion technology is tried as a cooptimization of target mask to simultaneously generate optimized main and sub-resolution assists features for a desired process window. Alternatively, its technology can also be used to optimize for a target feature after an assist feature types are inserted in order to simplify the mask complexity. Simplification of inversion mask is one of major issue with applying inversion technology to device development even if a smaller mask feature can be fabricated since the mask writing time is also a major factor. As shown in Figure 2, mask writing time may be a limiting factor in determining whether or not an inversion solution is viable. It can be reasoned that increased number of shot counts relates to increase in margin for inversion methodology. On the other hand, there is a limit on how complex a mask can be in order to be production worthy. There is also source and mask co-optimization which influences the final mask patterns and assist feature sizes and positions for a given target. In this study, we will discuss assist feature insertion methods for sub 40-nm technology.

A Randomized Crossover Trial Comparing Autotitrating and Continuous Positive Airway Pressure in Subjects With Symptoms of Aerophagia: Effects on Compliance and Subjective Symptoms.

PubMed

Shirlaw, Teresa; Hanssen, Kevin; Duce, Brett; Hukins, Craig

2017-07-15

To assess the benefit and tolerance of autotitrating positive airway pressure (APAP) versus continuous positive airway pressure (CPAP) in subjects who experience aerophagia. This is the report of a prospective, two-week, double-blinded, randomized crossover trial set in an Australian clinical sleep laboratory in a tertiary hospital. Fifty-six subjects who reported symptoms of aerophagia that they attributed to CPAP were recruited. Full face masks were used by 39 of the 56 subjects recruited. Subjects were randomly and blindly allocated to either CPAP at their treatment recommended pressure or APAP 6-20 cm H 2 O, in random order. Subjects spent two weeks on each therapy mode. Therapy usage hours, 95th centile pressure, maximum pressure, 95th centile leak, and residual apnea-hypopnea index (AHI) were reported at the end of each two-week treatment period. Functional Outcome of Sleepiness Questionnaire, Epworth Sleepiness Scale, and visual analog scale to measure symptoms of aerophagia were also completed at the end of each 2-week treatment arm. The median pressure ( P < .001) and 95th centile pressure ( P < .001) were reduced with APAP but no differences in compliance ( P = .120) and residual AHI were observed. APAP reduced the symptoms of bloating ( P = .011), worst episode of bloating ( P = .040), flatulence ( P = .010), and belching ( P = .001) compared to CPAP. There were no differences in Epworth Sleepiness Scale or Functional Outcome of Sleepiness Questionnaire outcomes between CPAP and APAP. APAP therapy reduces the symptoms of aerophagia while not affecting compliance when compared with CPAP therapy. Australian and New Zealand Clinical Trials Registry at https://www.anzctr.org.au, trial number ACTRN12611001250921. A commentary on this article appears in this issue on page 859. © 2017 American Academy of Sleep Medicine

LENS (lithography enhancement toward nano scale): a European project to support double exposure and double patterning technology development

NASA Astrophysics Data System (ADS)

Cantu, Pietro; Baldi, Livio; Piacentini, Paolo; Sytsma, Joost; Le Gratiet, Bertrand; Gaugiran, Stéphanie; Wong, Patrick; Miyashita, Hiroyuki; Atzei, Luisa R.; Buch, Xavier; Verkleij, Dick; Toublan, Olivier; Perez-Murano, Francesco; Mecerreyes, David

2010-04-01

In 2009 a new European initiative on Double Patterning and Double Exposure lithography process development was started in the framework of the ENIAC Joint Undertaking. The project, named LENS (Lithography Enhancement Towards Nano Scale), involves twelve companies from five different European Countries (Italy, Netherlands, France, Belgium Spain; includes: IC makers (Numonyx and STMicroelectronics), a group of equipment and materials companies (ASML, Lam Research srl, JSR, FEI), a mask maker (Dai Nippon Photomask Europe), an EDA company (Mentor Graphics) and four research and development institutes (CEA-Leti, IMEC, Centro Nacional de Microelectrónica, CIDETEC). The LENS project aims to develop and integrate the overall infrastructure required to reach patterning resolutions required by 32nm and 22nm technology nodes through the double patterning and pitch doubling technologies on existing conventional immersion exposure tools, with the purpose to allow the timely development of 32nm and 22nm technology nodes for memories and logic devices, providing a safe alternative to EUV, Higher Refraction Index Fluids Immersion Lithography and maskless lithography, which appear to be still far from maturity. The project will cover the whole lithography supply chain including design, masks, materials, exposure tools, process integration, metrology and its final objective is the demonstration of 22nm node patterning on available 1.35 NA immersion tools on high complexity mask set.

Evoked-potential recovery during double click stimulation in a beluga whale: implications for biosonar gain control.

PubMed

Supin, Alexander Ya; Popov, Vladimir V

2015-05-01

Auditory evoked potentials (AEPs) were recorded in a beluga whale Delphinapterus leucas using a double-pulse stimulation paradigm, specifically measuring the recovery (release from masking) of the second (test) response as a function of delay after the first (conditioning) pulse at various levels of the conditioning and test stimuli. The conditioning/test stimulus level ratio influenced the recovery time (the higher the ratio, the longer the recovery). This interrelation was used to evaluate the intensity/time trade in release from forward masking. Trade was evaluated as 32.2 dB per time decade. Data were considered as simulating interactions between the transmitted pulse and echo during echolocation, assuming that a transmitted sonar pulse produces forward masking of the echo response. With increased target distance, the attenuation of the echo may be compensated by the release from masking. According to the model, the compensation results in substantial stabilization of the echo response even if the intensity/time trade of release from masking is not precisely equal to the rate of echo attenuation with distance.

Effect of preoperative acetaminophen/hydrocodone on the efficacy of the inferior alveolar nerve block in patients with symptomatic irreversible pulpitis: a prospective, randomized, double-blind, placebo-controlled study.

PubMed

Fullmer, Spencer; Drum, Melissa; Reader, Al; Nusstein, John; Beck, Mike

2014-01-01

The purpose of this prospective, randomized, double-blind, placebo-controlled study was to determine the effect of the administration of the combination acetaminophen/hydrocodone on the anesthetic success of mandibular posterior teeth in patients experiencing symptomatic irreversible pulpitis. One hundred emergency patients in moderate to severe pain diagnosed with symptomatic irreversible pulpitis of a mandibular posterior tooth randomly received, in a double-blind manner, identical capsules of either a combination dose of 1000 mg acetaminophen/10 mg hydrocodone or placebo 60 minutes before the administration of a conventional inferior alveolar nerve (IAN) block. Endodontic access was begun 15 minutes after completion of the block, and all patients used for data analysis had profound lip numbness. Success was defined as no or mild pain (visual analog scale recordings) on pulpal access or instrumentation. The success rate for the IAN block was 32% for the combination dose of 1000 mg acetaminophen/10 hydrocodone and 28% for the placebo dose, with no statistically significant difference between the 2 groups (P = .662). A combination dose of 1000 mg acetaminophen/10 mg hydrocodone given 60 minutes before the administration of the IAN block did not result in a statistically significant increase in anesthetic success for mandibular posterior teeth in patients experiencing symptomatic irreversible pulpitis. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

TIRR regulates 53BP1 by masking its histone methyl-lysine binding function.

PubMed

Drané, Pascal; Brault, Marie-Eve; Cui, Gaofeng; Meghani, Khyati; Chaubey, Shweta; Detappe, Alexandre; Parnandi, Nishita; He, Yizhou; Zheng, Xiao-Feng; Botuyan, Maria Victoria; Kalousi, Alkmini; Yewdell, William T; Münch, Christian; Harper, J Wade; Chaudhuri, Jayanta; Soutoglou, Evi; Mer, Georges; Chowdhury, Dipanjan

2017-03-09

P53-binding protein 1 (53BP1) is a multi-functional double-strand break repair protein that is essential for class switch recombination in B lymphocytes and for sensitizing BRCA1-deficient tumours to poly-ADP-ribose polymerase-1 (PARP) inhibitors. Central to all 53BP1 activities is its recruitment to double-strand breaks via the interaction of the tandem Tudor domain with dimethylated lysine 20 of histone H4 (H4K20me2). Here we identify an uncharacterized protein, Tudor interacting repair regulator (TIRR), that directly binds the tandem Tudor domain and masks its H4K20me2 binding motif. Upon DNA damage, the protein kinase ataxia-telangiectasia mutated (ATM) phosphorylates 53BP1 and recruits RAP1-interacting factor 1 (RIF1) to dissociate the 53BP1-TIRR complex. However, overexpression of TIRR impedes 53BP1 function by blocking its localization to double-strand breaks. Depletion of TIRR destabilizes 53BP1 in the nuclear-soluble fraction and alters the double-strand break-induced protein complex centring 53BP1. These findings identify TIRR as a new factor that influences double-strand break repair using a unique mechanism of masking the histone methyl-lysine binding function of 53BP1.

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.

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

PubMed Central

2013-01-01

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

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

PubMed

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

2013-11-04

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

Image discrimination models predict detection in fixed but not random noise

NASA Technical Reports Server (NTRS)

Ahumada, A. J. Jr; Beard, B. L.; Watson, A. B. (Principal Investigator)

1997-01-01

By means of a two-interval forced-choice procedure, contrast detection thresholds for an aircraft positioned on a simulated airport runway scene were measured with fixed and random white-noise masks. The term fixed noise refers to a constant, or unchanging, noise pattern for each stimulus presentation. The random noise was either the same or different in the two intervals. Contrary to simple image discrimination model predictions, the same random noise condition produced greater masking than the fixed noise. This suggests that observers seem unable to hold a new noisy image for comparison. Also, performance appeared limited by internal process variability rather than by external noise variability, since similar masking was obtained for both random noise types.

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.

Prospective randomized assessment of single versus double-gloving for general surgical procedures.

PubMed

Na'aya, H U; Madziga, A G; Eni, U E

2009-01-01

There is increased tendency towards double-gloving by general surgeons in our practice, due probably to awareness of the risk of contamination with blood or other body fluids during surgery. The aim of the study was to compare the relative frequency of glove puncture in single-glove versus double glove sets in general surgical procedures, and to determine if duration of surgery affects perforation rate. Surgeons at random do single or double gloves at their discretion, for general surgical procedures. All the gloves used by the surgeons were assessed immediately after surgery for perforation. A total of 1120 gloves were tested, of which 880 were double-glove sets and 240 single-glove sets. There was no significant difference in the overall perforation rate between single and double glove sets (18.3% versus 20%). However, only 2.3% had perforations in both the outer and inner gloves in the double glove group. Therefore, there was significantly greater risk for blood-skin exposure in the single glove sets (p < 0.01). The perforation rate was also significantly greater during procedures lasting an hour or more compared to those lasting less than an hour (p < 0.01). Double-gloving reduces the risk of blood-skin contamination in all general surgical procedures, and especially so in procedures lasting an hour or more.

Delaying in vivo exposure to a tarantula with very brief exposure to phobic stimuli.

PubMed

Siegel, Paul; Gallagher, Kimberly Alyse

2015-03-01

Research has documented the very brief exposure (VBE) effect: the reduction of phobic fear by continuous presentation of masked phobic pictures. In prior studies, phobic participants approached a live tarantula immediately after the masked stimuli were presented. This study tested the hypothesis that VBE would reduce phobic avoidance of the tarantula 24 h later. 86 spider-phobic participants were identified with a fear questionnaire and Behavioral Avoidance Test (BAT) with a live tarantula indicative of a DSM-IV diagnosis of Specific Phobia. One week later, they were randomly assigned in double-blind fashion to presentation of a continuous series of 25 trials of masked images of either spiders or flowers (33-ms each), i.e., to VBE or control exposure. The participants gave subjective distress ratings just before and after these exposures. Then they engaged in the BAT again either immediately thereafter or 24 h later to measure changes in avoidance of the tarantula. Masked images of spiders reduced avoidance of the tarantula both immediately after exposure and 24 h later without causing subjective distress. The effect sizes at these two time points did not significantly differ from each other. We did not manipulate awareness of the spider images by presenting them unmasked to a third group. Conclusions about the effect of awareness of the stimuli cannot be drawn. VBE induces a process of fear reduction before phobic individuals engage in in vivo exposure, which is more distressing. Thus, VBE may help phobic-resistant individuals start treatment more gradually.

Comparative evaluation of effect of preoperative oral medication of ibuprofen and ketorolac on anesthetic efficacy of inferior alveolar nerve block with lidocaine in patients with irreversible pulpitis: a prospective, double-blind, randomized clinical trial.

PubMed

Aggarwal, Vivek; Singla, Mamta; Kabi, Debipada

2010-03-01

Anesthetic efficacy of inferior alveolar nerve block decreases in patients with irreversible pulpitis. It was hypothesized that premedication with nonsteroidal anti-inflammatory drugs might improve the success rates in patients with inflamed pulps. Sixty-nine adult volunteers who were actively experiencing pain participated in this prospective, randomized, double-blind study. The patients were divided into 3 groups on a random basis and were randomly given 1 of the 3 drugs including ibuprofen, ketorolac, and placebo 1 hour before anesthesia. All patients received standard inferior alveolar nerve block of 2% lidocaine with 1:200,000 epinephrine. Endodontic access preparation was initiated after 15 minutes of initial inferior alveolar nerve block. Pain during treatment was recorded by using a Heft Parker visual analog scale. Success was recorded as none or mild pain. Statistical analysis with nonparametric chi2 tests showed that placebo gave 29% success rate. Premedication with ibuprofen gave 27%, and premedication with ketorolac gave 39% success rate. There was no significant difference between the 3 groups. Preoperative administration of ibuprofen or ketorolac has no significant effect on success rate of inferior alveolar nerve block in patients with irreversible pulpitis. Copyright (c) 2010 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

In-die mask registration measurement on 28nm-node and beyond

NASA Astrophysics Data System (ADS)

Chen, Shen Hung; Cheng, Yung Feng; Chen, Ming Jui

2013-09-01

As semiconductor go to smaller node, the critical dimension (CD) of process become more and more small. For lithography, RET (Resolution Enhancement Technology) applications can be used for wafer printing of smaller CD/pitch on 28nm node and beyond. SMO (Source Mask Optimization), DPT (Double Patterning Technology) and SADP (Self-Align Double Patterning) can provide lower k1 value for lithography. In another way, image placement error and overlay control also become more and more important for smaller chip size (advanced node). Mask registration (image placement error) and mask overlay are important factors to affect wafer overlay control/performance especially for DPT or SADP. In traditional method, the designed registration marks (cross type, square type) with larger CD were put into scribe-line of mask frame for registration and overlay measurement. However, these patterns are far way from real patterns. It does not show the registration of real pattern directly and is not a convincing method. In this study, the in-die (in-chip) registration measurement is introduced. We extract the dummy patterns that are close to main pattern from post-OPC (Optical Proximity Correction) gds by our desired rule and choose the patterns that distribute over whole mask uniformly. The convergence test shows 100 points measurement has a reliable result.

Randomized trial of the effect of drug presentation on asthma outcomes: the American Lung Association Asthma Clinical Research Centers.

PubMed

Wise, Robert A; Bartlett, Susan J; Brown, Ellen D; Castro, Mario; Cohen, Rubin; Holbrook, Janet T; Irvin, Charles G; Rand, Cynthia S; Sockrider, Marianna M; Sugar, Elizabeth A

2009-09-01

Information that enhances expectations about drug effectiveness improves the response to placebos for pain. Although asthma symptoms often improve with placebo, it is not known whether the response to placebo or active treatment can be augmented by increasing expectation of benefit. The study objective was to determine whether response to placebo or a leukotriene antagonist (montelukast) can be augmented by messages that increase expectation of benefit. A randomized 20-center controlled trial enrolled 601 asthmatic patients with poor symptom control who were assigned to one of 5 study groups. Participants were randomly assigned to one of 4 treatment groups in a factorial design (ie, placebo with enhanced messages, placebo with neutral messages, montelukast with enhanced messages, or montelukast with neutral messages) or to usual care. Assignment to study drug was double masked, assignment to message content was single masked, and usual care was not masked. The enhanced message aimed to increase expectation of benefit from the drug. The primary outcome was mean change in daily peak flow over 4 weeks. Secondary outcomes included lung function and asthma symptom control. Peak flow and other lung function measures were not improved in participants assigned to the enhanced message groups versus the neutral messages groups for either montelukast or placebo; no differences were noted between the neutral placebo and usual care groups. Placebo-treated participants had improved asthma control with the enhanced message but not montelukast-treated participants; the neutral placebo group did have improved asthma control compared with the usual care group after adjusting for baseline difference. Headaches were more common in participants provided messages that mentioned headache as a montelukast side effect. Optimistic drug presentation augments the placebo effect for patient-reported outcomes (asthma control) but not lung function. However, the effect of montelukast was not enhanced by optimistic messages regarding treatment effectiveness.

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.

A Prospective, Randomized, Masked, Placebo-Controlled Multisite Clinical Study of Grapiprant, an EP4 Prostaglandin Receptor Antagonist (PRA), in Dogs with Osteoarthritis.

PubMed

Rausch-Derra, L; Huebner, M; Wofford, J; Rhodes, L

2016-05-01

This study evaluated the effectiveness and safety of grapiprant for treatment of pain in dogs with osteoarthritis (OA). Grapiprant will relieve pain as measured by the owner's and veterinarian's evaluation of pain in dogs with OA. Another objective was evaluation of the safety of grapiprant. Two hundred and eighty-five client-owned dogs with OA were enrolled and treated with grapiprant or placebo with 262 cases (N = 131 in each group) evaluable for the effectiveness analysis. In this prospective, randomized, masked, placebo-controlled study dogs were treated daily with grapiprant (2 mg/kg) per OS or placebo. Owners completed an evaluation using the Canine Brief Pain Inventory (CBPI) on days 0, 7, 14, 21, and 28. Success was defined as improvement in the CBPI. Veterinary assessments were made on screening and days 14 and 28. Safety was evaluated by physical examination, evaluation of clinical pathology results, and owner observations. Grapiprant treatment improved pain compared to placebo on day 28 (48.1 and 31.3% treatment successes respectively; P = .0315). The pain interference score (PIS) and pain severity score (PSS) improved in the grapiprant group compared to placebo (P = .0029 and 0.0022, respectively). Veterinary assessments were significantly better in the grapiprant-treated dogs (P = .0086). Grapiprant generally was well tolerated, but a higher percentage of treated dogs (17.02%) had occasional vomiting as compared to the placebo group (6.25%). Grapiprant is an effective treatment for alleviation of pain in dogs with OA, and represents a modality of treatment that may be better tolerated than current options. Copyright © 2016 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

A prospective, randomized, double-blind study, comparing unirradiated to irradiated white blood cell transfusions in acute leukemia patients

PubMed Central

Freireich, E J; Lichtiger, B; Mattiuzzi, G; Martinez, F; Reddy, V; Kyle Wathen, J

2013-01-01

A prospective, randomized double-blind study comparing the effects of irradiated and unirradiated white blood cells was conducted in 108 acute leukemia patients with life-threatening infections, refractory to antibiotics. The study demonstrated no significant improvement in 30-day survival or overall survival. Transfusion of unirradiated white cells did not compromise the patient's opportunity to undergo allogeneic stem cell transplant, nor the success rate or overall survival after allogeneic transplant. The important positive finding in this study was that the unirradiated white cells produced a significantly higher increment in circulating granulocytes and in a higher proportion of patients granulocyte count exceeded 1000 per microliter, approaching normal concentrations. The increase in the number and the improved survival of the unirradiated granulocytes suggest that this procedure might potentially be a method to improve the utility of granulocyte transfusions and merits further investigation. The study demonstrated non-inferiority for unirradiated white cells. There were no harmful effects such as graft-versus-host disease, indicating that such studies would be safe to conduct in the future. PMID:23072780

Effectiveness of Bupivacaine Liposome Injectable Suspension for Postoperative Pain Control in Total Knee Arthroplasty: A Prospective, Randomized, Double Blind, Controlled Study.

PubMed

DeClaire, Jeffrey H; Aiello, Paige M; Warritay, Olayinka K; Freeman, Dwight C

2017-09-01

We compared the effectiveness of liposomal bupivacaine to ropivacaine, each as part of multimodal pain management, in total knee arthroplasty (TKA) postoperative pain control. This prospective, double blind study randomized 96 TKA patients into a control group (periarticular injection of ropivacaine, ketorolac, morphine, and epinephrine in saline; 100cc) or an experimental group (periarticular injection of bupivacaine, ketorolac, morphine, and epinephrine in saline; 80cc plus 1.3% liposomal bupivacaine 20cc; total injection 100cc). The postoperative use of narcotics, visual analog pain scores, hours to ambulate 100 feet, and length of hospital stay were recorded. There was no significant difference between the two groups (control N = 49, experiment N = 47) in mean narcotic use per hour, total narcotic use during hospital stay, time to ambulate 100 feet, length of hospital stay, or visual analog score for pain postoperatively. There is no benefit in the use of liposomal bupivacaine compared with ropivacaine for postoperative pain control in TKA. Copyright © 2017 Elsevier Inc. All rights reserved.

Optical image encryption using chaos-based compressed sensing and phase-shifting interference in fractional wavelet domain

NASA Astrophysics Data System (ADS)

Liu, Qi; Wang, Ying; Wang, Jun; Wang, Qiong-Hua

2018-02-01

In this paper, a novel optical image encryption system combining compressed sensing with phase-shifting interference in fractional wavelet domain is proposed. To improve the encryption efficiency, the volume data of original image are decreased by compressed sensing. Then the compacted image is encoded through double random phase encoding in asymmetric fractional wavelet domain. In the encryption system, three pseudo-random sequences, generated by three-dimensional chaos map, are used as the measurement matrix of compressed sensing and two random-phase masks in the asymmetric fractional wavelet transform. It not only simplifies the keys to storage and transmission, but also enhances our cryptosystem nonlinearity to resist some common attacks. Further, holograms make our cryptosystem be immune to noises and occlusion attacks, which are obtained by two-step-only quadrature phase-shifting interference. And the compression and encryption can be achieved in the final result simultaneously. Numerical experiments have verified the security and validity of the proposed algorithm.

Clinical Efficacy of Intravenous Lidocaine for Thyroidectomy: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.

PubMed

Choi, Geun Joo; Kang, Hyun; Ahn, Eun Jin; Oh, Jong In; Baek, Chong Wha; Jung, Yong Hun; Kim, Jin Yun

2016-12-01

Systemic lidocaine has analgesic and anti-inflammatory effects. The purpose of this prospective, randomized, double-blind study was to evaluate the effects of intravenous lidocaine on pain following thyroidectomy. Fifty-eight adult patients scheduled for total thyroidectomy were randomly allocated to receive a 1.5 mg/kg lidocaine bolus followed by a 2 mg/kg/h infusion during surgery, or the same volume of normal saline (control). After thyroidectomy, we evaluated postoperative pain, nausea, fentanyl consumption, frequency of pushing the button (FPB) for patient-controlled analgesia (PCA), High-sensitivity C-reactive protein (hs-CRP) in serum, and patient satisfaction scores regarding the recovery process. Postoperative pain and nausea scores were significantly lower in the lidocaine group for the first 4 h following thyroidectomy, compared to the control group. Fentanyl consumption and FPB for the PCA were also significantly reduced in the lidocaine group for 4 h following thyroidectomy, and hs-CRP was significantly less in the lidocaine group at postoperative days 1 and 3. Furthermore, satisfaction scores were significantly higher in the lidocaine group compared to the control group. Intravenous lidocaine effectively reduced postoperative pain and nausea following thyroidectomy as well as improved the quality of recovery. Clinicaltrials.gov NCT01608360.

Phenobarbital for acute alcohol withdrawal: a prospective randomized double-blind placebo-controlled study.

PubMed

Rosenson, Jonathan; Clements, Carter; Simon, Barry; Vieaux, Jules; Graffman, Sarah; Vahidnia, Farnaz; Cisse, Bitou; Lam, Joseph; Alter, Harrison

2013-03-01

Acute alcohol withdrawal syndrome (AAWS) is encountered in patients presenting acutely to the Emergency Department (ED) and often requires pharmacologic management. We investigated whether a single dose of intravenous (i.v.) phenobarbital combined with a standardized lorazepam-based alcohol withdrawal protocol decreases intensive care unit (ICU) admission in ED patients with acute alcohol withdrawal. This was a prospective, randomized, double-blind, placebo-controlled study. Patients were randomized to receive either a single dose of i.v. phenobarbital (10 mg/kg in 100 mL normal saline) or placebo (100 mL normal saline). All patients were placed on the institutional symptom-guided lorazepam-based alcohol withdrawal protocol. The primary outcome was initial level of hospital admission (ICU vs. telemetry vs. floor ward). There were 198 patients enrolled in the study, and 102 met inclusion criteria for analysis. Fifty-one patients received phenobarbital and 51 received placebo. Baseline characteristics and severity were similar in both groups. Patients that received phenobarbital had fewer ICU admissions (8% vs. 25%, 95% confidence interval 4-32). There were no differences in adverse events. A single dose of i.v. phenobarbital combined with a symptom-guided lorazepam-based alcohol withdrawal protocol resulted in decreased ICU admission and did not cause increased adverse outcomes. Copyright © 2013 Elsevier Inc. All rights reserved.

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.

Transcutaneous electrical nerve stimulation for postoperative pain relief after arthroscopic rotator cuff repair: a prospective double-blinded randomized trial.

PubMed

Mahure, Siddharth A; Rokito, Andrew S; Kwon, Young W

2017-09-01

Arthroscopic rotator cuff repair (ARCR) can be associated with significant postoperative pain. Concern for opioid abuse has led surgeons to identify alternative, efficacious methods of postoperative analgesia. To determine whether transcutaneous electrical nerve stimulation (TENS) can have a similarly beneficial effect after shoulder procedures, we conducted a prospective double-blinded randomized trial in patients undergoing outpatient ARCR. All patients undergoing ARCR of a full-thickness rotator cuff tear by the senior authors were identified. Patients with a history of recent narcotic use or prior narcotic abuse and those under management of a pain control specialist were excluded. Patients were randomized into 2 groups, active or placebo TENS, and used the device for 4 sessions/day for 45 minutes/session for the first postoperative week. All patients received Percocet 5/325 mg (oxycodone/acetaminophen) for use as rescue pain pills. One-week narcotic consumption and visual analog scale pain scores were compared between groups. The final analysis included 37 patients (21 active,16 placebo). Baseline and procedural differences were not different between groups. At 1 week postoperatively, patients in the active group had significantly lower pain scores (3.6 ± 2.1 vs. 5.8 ± 1.2; P= .008). Postoperative Percocet consumption during the initial 48 hours (12.8 ± 4.7 vs. 17.2 ± 6.3; P = .020) and during the first week (25.2 ± 9.9 vs. 33.8 ± 14.3; P = .037) was also significantly lower in the active group. Results from this prospective double-blinded randomized trial demonstrate that compared with placebo TENS, active TENS can result in significantly less pain and reduced opioid use in the immediate postoperative period after ARCR, suggesting that TENS may be potentially useful in a multimodal approach to managing postoperative pain. Copyright © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Prospective, Randomized, Double-Blind, Phase III Clinical Trial of Anti-T-Lymphocyte Globulin to Assess Impact on Chronic Graft-Versus-Host Disease-Free Survival in Patients Undergoing HLA-Matched Unrelated Myeloablative Hematopoietic Cell Transplantation.

PubMed

Soiffer, Robert J; Kim, Haesook T; McGuirk, Joseph; Horwitz, Mitchell E; Johnston, Laura; Patnaik, Mrinal M; Rybka, Witold; Artz, Andrew; Porter, David L; Shea, Thomas C; Boyer, Michael W; Maziarz, Richard T; Shaughnessy, Paul J; Gergis, Usama; Safah, Hana; Reshef, Ran; DiPersio, John F; Stiff, Patrick J; Vusirikala, Madhuri; Szer, Jeff; Holter, Jennifer; Levine, James D; Martin, Paul J; Pidala, Joseph A; Lewis, Ian D; Ho, Vincent T; Alyea, Edwin P; Ritz, Jerome; Glavin, Frank; Westervelt, Peter; Jagasia, Madan H; Chen, Yi-Bin

2017-12-20

Purpose Several open-label randomized studies have suggested that in vivo T-cell depletion with anti-T-lymphocyte globulin (ATLG; formerly antithymocyte globulin-Fresenius) reduces chronic graft-versus-host disease (cGVHD) without compromising survival. We report a prospective, double-blind phase III trial to investigate the effect of ATLG (Neovii Biotech, Lexington, MA) on cGVHD-free survival. Patients and Methods Two hundred fifty-four patients 18 to 65 years of age with acute leukemia or myelodysplastic syndrome who underwent myeloablative HLA-matched unrelated hematopoietic cell transplantation (HCT) were randomly assigned one to one to placebo (n =128 placebo) or ATLG (n = 126) treatment at 27 sites. Patients received either ATLG or placebo 20 mg/kg per day on days -3, -2, -1 in addition to tacrolimus and methotrexate as GVHD prophylaxis. The primary study end point was moderate-severe cGVHD-free survival. Results Despite a reduction in grade 2 to 4 acute GVHD (23% v 40%; P = .004) and moderate-severe cGVHD (12% v 33%; P < .001) in ATLG recipients, no difference in moderate-severe cGVHD-free survival between ATLG and placebo was found (2-year estimate: 48% v 44%, respectively; P = .47). Both progression-free survival (PFS) and overall survival (OS) were lower with ATLG (2-year estimate: 47% v 65% [ P = .04] and 59% v 74% [ P = .034], respectively). Multivariable analysis confirmed that ATLG was associated with inferior PFS (hazard ratio, 1.55; 95% CI, 1.05 to 2.28; P = .026) and OS (hazard ratio, 1.74; 95% CI, 1.12 to 2.71; P = .01). Conclusion In this prospective, randomized, double-blind trial of ATLG in unrelated myeloablative HCT, the incorporation of ATLG did not improve moderate-severe cGVHD-free survival. Moderate-severe cGVHD was significantly lower with ATLG, but PFS and OS also were lower. Additional analyses are needed to understand the appropriate role for ATLG in HCT.

Effect of transversus abdominis plane block in combination with general anesthesia on perioperative opioid consumption, hemodynamics, and recovery in living liver donors: The prospective, double-blinded, randomized study.

PubMed

Erdogan, Mehmet A; Ozgul, Ulku; Uçar, Muharrem; Yalin, Mehmet R; Colak, Yusuf Z; Çolak, Cemil; Toprak, Huseyin I

2017-04-01

Transversus abdominis plane (TAP) block provides effective postoperative analgesia after abdominal surgeries. It can be also a useful strategy to reduce perioperative opioid consumption, support intraoperative hemodynamic stability, and promote early recovery from anesthesia. The aim of this prospective randomized double-blind study was to assess the effect of subcostal TAP blocks on perioperative opioid consumption, hemodynamic, and recovery time in living liver donors. The prospective, double-blinded, randomized controlled study was conducted with 49 living liver donors, aged 18-65 years, who were scheduled to undergo right hepatectomy. Patients who received subcostal TAP block in combination with general anesthesia were allocated into Group 1, and patients who received general anesthesia alone were allocated into Group 2. The TAP blocks were performed bilaterally by obtaining an image with real-time ultrasound guidance using 0.5% bupivacaine diluted with saline to reach a total volume of 40 mL. The primary outcome measure in our study was perioperative remifentanil consumption. Secondary outcomes were mean blood pressure (MBP), heart rate (HR), mean desflurane requirement, anesthesia recovery time, frequency of emergency vasopressor use, total morphine use, and length of hospital stay. Total remifentanil consumption and the anesthesia recovery time were significantly lower in Group 1 compared with Group 2. Postoperative total morphine use and length of hospital stay were also reduced. Changes in the MAP and HR were similar in the both groups. There were no significant differences in HR and MBP between groups at any time. Combining subcostal TAP blocks with general anesthesia significantly reduced perioperative and postoperative opioid consumption, provided shorter anesthesia recovery time, and length of hospital stay in living liver donors. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A Randomized Crossover Trial Comparing Autotitrating and Continuous Positive Airway Pressure in Subjects With Symptoms of Aerophagia: Effects on Compliance and Subjective Symptoms

PubMed Central

Shirlaw, Teresa; Hanssen, Kevin; Duce, Brett; Hukins, Craig

2017-01-01

Study Objectives: To assess the benefit and tolerance of autotitrating positive airway pressure (APAP) versus continuous positive airway pressure (CPAP) in subjects who experience aerophagia. Methods: This is the report of a prospective, two-week, double-blinded, randomized crossover trial set in an Australian clinical sleep laboratory in a tertiary hospital. Fifty-six subjects who reported symptoms of aerophagia that they attributed to CPAP were recruited. Full face masks were used by 39 of the 56 subjects recruited. Subjects were randomly and blindly allocated to either CPAP at their treatment recommended pressure or APAP 6–20 cm H2O, in random order. Subjects spent two weeks on each therapy mode. Therapy usage hours, 95th centile pressure, maximum pressure, 95th centile leak, and residual apnea-hypopnea index (AHI) were reported at the end of each two-week treatment period. Functional Outcome of Sleepiness Questionnaire, Epworth Sleepiness Scale, and visual analog scale to measure symptoms of aerophagia were also completed at the end of each 2-week treatment arm. Results: The median pressure (P < .001) and 95th centile pressure (P < .001) were reduced with APAP but no differences in compliance (P = .120) and residual AHI were observed. APAP reduced the symptoms of bloating (P = .011), worst episode of bloating (P = .040), flatulence (P = .010), and belching (P = .001) compared to CPAP. There were no differences in Epworth Sleepiness Scale or Functional Outcome of Sleepiness Questionnaire outcomes between CPAP and APAP. Conclusions: APAP therapy reduces the symptoms of aerophagia while not affecting compliance when compared with CPAP therapy. Clinical Trial Registration: Australian and New Zealand Clinical Trials Registry at https://www.anzctr.org.au, trial number ACTRN12611001250921. Commentary: A commentary on this article appears in this issue on page 859. Citation: Shirlaw T, Hanssen K, Duce B, Hukins C. A randomized crossover trial comparing autotitrating and continuous positive airway pressure in subjects with symptoms of aerophagia: effects on compliance and subjective symptoms. J Clin Sleep Med. 2017;13(7):881–888. PMID:28558864

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

Double-blind trial of recombinant gamma-interferon versus placebo in the treatment of rheumatoid arthritis. 1989.

PubMed

Cannon, Grant W; Pincus, Seth H; Emkey, Ronald D; Denes, Alex; Cohen, Selwyn A; Wolfe, Frederick; Saway, P Anthony; Jaffer, Adrian M; Weaver, Arthur L; Cogen, Lewis; Schindler, John D

2008-02-01

One hundred five patients were enrolled in a 12-week, randomized, prospective, double-blind, placebo-controlled trial of recombinant human gamma-interferon (rHu gamma-IFN) for the treatment of rheumatoid arthritis. Fifty-four patients received rHu gamma-IFN and 51 received placebo. Forty-two patients in each group completed the 12-week trial. Some clinical improvement occurred in both groups of patients. Although the improvement with rHu gamma-IFN was greater than that with placebo, the differences were generally not statistically significant.

Randomized trial of anesthetic methods for intravitreal injections.

PubMed

Blaha, Gregory R; Tilton, Elisha P; Barouch, Fina C; Marx, Jeffrey L

2011-03-01

To compare the effectiveness of four different anesthetic methods for intravitreal injection. Twenty-four patients each received four intravitreal injections using each of four types of anesthesia (proparacaine, tetracaine, lidocaine pledget, and subconjunctival injection of lidocaine) in a prospective, masked, randomized block design. Pain was graded by the patient on a 0 to 10 scale for both the anesthesia and the injection. The average combined pain scores for both the anesthesia and the intravitreal injection were 4.4 for the lidocaine pledget, 3.5 for topical proparacaine, 3.8 for the subconjunctival lidocaine injection, and 4.1 for topical tetracaine. The differences were not significant (P = 0.65). There were also no statistical differences in the individual anesthesia or injection pain scores. Subconjunctival lidocaine injection had the most side effects. Topical anesthesia is an effective method for limiting pain associated with intravitreal injections.

A Phase III Randomized Clinical Trial of a 0.5% Timolol + 0.2% Brimonidine + 2.0% Dorzolamide Fixed Combination, Preservative-Free Ophthalmic Solution vs. 0.5% Timolol + 0.2% Brimonidine + 2.0% Dorzolamide Fixed Combination in Patients with Controlled Primary Open-Angle Glaucoma.

PubMed

Gómez-Aguayo, Francisco; Paczka, José A; Leñero-Córdova, Rubén; Jiménez-Román, Jesús; Davila-Villarreal, Jaime; Hartleben, Curt; Baiza-Durán, Leopoldo; Olvera-Montaño, Oscar; García-Velez, Francisco; Muñoz-Villegas, Patricia

2018-06-01

The aim of this prospective crossover study was to evaluate the non-inferiority of PRO-122 (a preservative-free fixed combination) compared with 0.5% timolol + 0.2% brimonidine + 2.0% dorzolamide fixed combination (KOF) by evaluating its efficacy, tolerability and safety in subjects with controlled primary open-angle glaucoma (POAG) previously treated with KOF for at least 2 months. In a prospective, crossover, randomized, double-masked multicenter study, patients previously treated with KOF were randomly assigned to receive either PRO-122 or KOF for 30 days. On day 31, the A sequence changed to KOF, while the B sequence received PRO-122. All patients remained in the protocol for 30 additional days for a total of 60 days. The main efficacy endpoint was maintaining the controlled intraocular pressure (IOP). The safety and tolerability of both products were assessed by the presence of adverse events (AEs), ocular findings, a questionnaire on ocular comfort and the VF-14 index. A total of 51 patients participated. After application of PRO-122 twice a day, its efficacy was demonstrated through maintenance of the controlled IOP in patients previously controlled with KOF. The crossover between PRO-122 and KOF and vice versa, after 30 days of use, did not affect IOP control. PRO-122 was shown not to be inferior to KOF in maintaining IOP at control levels. The safety of both drugs is similar, as neither presented drug-related AEs or differences regarding safety issues. The tolerability of the two medications-evaluated by ocular findings, the questionnaire on ocular comfort and the VF-14 index-was also determined to be similar. The controlled IOP in patients with controlled POAG treated with PRO-122 was maintained both in relation to the initial controlled IOP of the study and when compared with KOF in the B sequence. Finally, the treatment with PRO-122 demonstrated similar safety and tolerability to KOF. Laboratorios Sophia, S.A. de C.V. (Zapopan, Jalisco, México). ClinicalTrials.gov identifier: NCT03257813 (registered retrospectively).

Effect of random phase mask on input plane in photorefractive authentic memory with two-wave encryption method

NASA Astrophysics Data System (ADS)

Mita, Akifumi; Okamoto, Atsushi; Funakoshi, Hisatoshi

2004-06-01

We have proposed an all-optical authentic memory with the two-wave encryption method. In the recording process, the image data are encrypted to a white noise by the random phase masks added on the input beam with the image data and the reference beam. Only reading beam with the phase-conjugated distribution of the reference beam can decrypt the encrypted data. If the encrypted data are read out with an incorrect phase distribution, the output data are transformed into a white noise. Moreover, during read out, reconstructions of the encrypted data interfere destructively resulting in zero intensity. Therefore our memory has a merit that we can detect unlawful accesses easily by measuring the output beam intensity. In our encryption method, the random phase mask on the input plane plays important roles in transforming the input image into a white noise and prohibiting to decrypt a white noise to the input image by the blind deconvolution method. Without this mask, when unauthorized users observe the output beam by using CCD in the readout with the plane wave, the completely same intensity distribution as that of Fourier transform of the input image is obtained. Therefore the encrypted image will be decrypted easily by using the blind deconvolution method. However in using this mask, even if unauthorized users observe the output beam using the same method, the encrypted image cannot be decrypted because the observed intensity distribution is dispersed at random by this mask. Thus it can be said the robustness is increased by this mask. In this report, we compare two correlation coefficients, which represents the degree of a white noise of the output image, between the output image and the input image in using this mask or not. We show that the robustness of this encryption method is increased as the correlation coefficient is improved from 0.3 to 0.1 by using this mask.

Hyperbaric Oxygen Environment Can Enhance Brain Activity and Multitasking Performance

PubMed Central

Vadas, Dor; Kalichman, Leonid; Hadanny, Amir; Efrati, Shai

2017-01-01

Background: The Brain uses 20% of the total oxygen supply consumed by the entire body. Even though, <10% of the brain is active at any given time, it utilizes almost all the oxygen delivered. In order to perform complex tasks or more than one task (multitasking), the oxygen supply is shifted from one brain region to another, via blood perfusion modulation. The aim of the present study was to evaluate whether a hyperbaric oxygen (HBO) environment, with increased oxygen supply to the brain, will enhance the performance of complex and/or multiple activities. Methods: A prospective, double-blind randomized control, crossover trial including 22 healthy volunteers. Participants were asked to perform a cognitive task, a motor task and a simultaneous cognitive-motor task (multitasking). Participants were randomized to perform the tasks in two environments: (a) normobaric air (1 ATA 21% oxygen) (b) HBO (2 ATA 100% oxygen). Two weeks later participants were crossed to the alternative environment. Blinding of the normobaric environment was achieved in the same chamber with masks on while hyperbaric sensation was simulated by increasing pressure in the first minute and gradually decreasing to normobaric environment prior to tasks performance. Results: Compared to the performance at normobaric conditions, both cognitive and motor single tasks scores were significantly enhanced by HBO environment (p < 0.001 for both). Multitasking performance was also significantly enhanced in HBO environment (p = 0.006 for the cognitive part and p = 0.02 for the motor part). Conclusions: The improvement in performance of both single and multi-tasking while in an HBO environment supports the hypothesis which according to, oxygen is indeed a rate limiting factor for brain activity. Hyperbaric oxygenation can serve as an environment for brain performance. Further studies are needed to evaluate the optimal oxygen levels for maximal brain performance. PMID:29021747

Safety and Tolerability of Lactobacillus reuteri DSM 17938 and Effects on Biomarkers in Healthy Adults: Results from a Randomized Masked Trial

PubMed Central

Fatheree, Nicole Y.; Ferris, Michael J.; Van Arsdall, Melissa R.; Chen, Zhongxue; Rahbar, Mohammad H.; Gleason, Wallace A.; Norori, Johana; Tran, Dat Q.; Rhoads, J. Marc

2012-01-01

Background There are few carefully-designed studies investigating the safety of individual probiotics approved under Investigational New Drug policies. Objectives The primary aim of this prospective, double-blind placebo-controlled trial was to investigate if daily treatment of adults with Lactobacillus reuteri DSM 17938 (LR) for 2 months is safe and well-tolerated. Our secondary aim was to determine if LR treatment has immune effects as determined by regulatory T cell percentages, expression of toll-like receptors (TLR)-2 and −4 on circulating peripheral blood mononuclear cells (PMBCs), cytokine expression by stimulated PBMC, and intestinal inflammation as measured by fecal calprotectin. Methods Forty healthy adults were randomized to a daily dose of 5×108 CFUs of LR (n = 30) or placebo (n = 10) for 2 months. Participants completed a daily diary card and had 7 clinic visits during treatment and observation. Results There were no severe adverse events (SAEs) and no significant differences in adverse events (AEs). There were no differences in PBMC subclasses, TLRs, or cytokine expression after treatment. The probiotic-treated group had a significantly higher fecal calprotectin level than the placebo group after 2 months of treatment: 50 µg/g (IQR 24–127 µg/g) vs. 17 µg/g (IQR 11–26 µg/g), p = 0.03, although values remained in the normal clinical range (0–162.9 µg/g). LR vials retained >108 CFUs viable organisms/ml. Conclusions LR is safe and well tolerated in adults, without significant changes in immunologic markers. There was a small but significant increase in fecal calprotectin, perhaps indicating some element of immune recognition at the intestinal level. Trial Registration Clinical Trials.gov NCT00922727 PMID:22970150

Effect of latanoprost/timolol and dorzolamide/tiomolol on intraocular pressure after phacoemulsification surgery

PubMed Central

Erdogan, Haydar; Ozec, Ayse Vural; Caner, Cengiz; Toker, Mustafa Ilker; Arici, Mustafa Kemal; Topalkara, Aysen

2011-01-01

AIM To evalaute the effect of fixed-combination latanoprost 0.005%/timolol maleate 0.5% and dorzolamide hydrochloride 2%/timolol maleate 0.5% on postoperative intraocular pressure after phacoemulsification cataract surgery. METHODS This study is a prospective, randomized, double-masked and placebo-controlled. The study included 90 eyes of 90 patients which were scheduled to have phacoemulsification surgery. Patients were randomly assigned preoperatively to 1 of 3 groups (30 eyes of 30 patients). Two hour before surgery, the patients received one drop latanoprost/timolol (group 1), dorzolamide/timolol (group 2) and placebo (group 3, control group). The IOPs were measured at preoperative and postoperative 4, 8, and 24 hours. RESULTS The preoperative mean intraocular pressure was not statistically significant between both drug groups and control group. In group 1 and 2, the postoperative mean IOP [group1: (14.03±3.15)mmHg and group 2: (14.16±4.43)mmHg] at 24 hours were significantly lower than the control group [(16.93±3.70)mmHg, (P<0.05)]. In addition, the postoperative mean IOP of group 1 [(14.90±3.69)mmHg] at 8 hours was significantly lower than the control group [(17.70±3.89)mmHg, (P<0.05)], but there was no significant difference between group 2 [(16.16±5.23)mmHg] and control group at 8 hours (P>0.05). CONCLUSION When compared with placebo, the use of preoperative fixed combination of latanoprost/timolol and dorzolamide/timolol is an effective method for preventing intraocular pressure elevation in 24 hours after phacoemulsification surgery, but did not completely prevent IOP spikes. PMID:22553640

Hyperbaric Oxygen Environment Can Enhance Brain Activity and Multitasking Performance.

PubMed

Vadas, Dor; Kalichman, Leonid; Hadanny, Amir; Efrati, Shai

2017-01-01

Background: The Brain uses 20% of the total oxygen supply consumed by the entire body. Even though, <10% of the brain is active at any given time, it utilizes almost all the oxygen delivered. In order to perform complex tasks or more than one task (multitasking), the oxygen supply is shifted from one brain region to another, via blood perfusion modulation. The aim of the present study was to evaluate whether a hyperbaric oxygen (HBO) environment, with increased oxygen supply to the brain, will enhance the performance of complex and/or multiple activities. Methods: A prospective, double-blind randomized control, crossover trial including 22 healthy volunteers. Participants were asked to perform a cognitive task, a motor task and a simultaneous cognitive-motor task (multitasking). Participants were randomized to perform the tasks in two environments: (a) normobaric air (1 ATA 21% oxygen) (b) HBO (2 ATA 100% oxygen). Two weeks later participants were crossed to the alternative environment. Blinding of the normobaric environment was achieved in the same chamber with masks on while hyperbaric sensation was simulated by increasing pressure in the first minute and gradually decreasing to normobaric environment prior to tasks performance. Results: Compared to the performance at normobaric conditions, both cognitive and motor single tasks scores were significantly enhanced by HBO environment ( p < 0.001 for both). Multitasking performance was also significantly enhanced in HBO environment ( p = 0.006 for the cognitive part and p = 0.02 for the motor part). Conclusions: The improvement in performance of both single and multi-tasking while in an HBO environment supports the hypothesis which according to, oxygen is indeed a rate limiting factor for brain activity. Hyperbaric oxygenation can serve as an environment for brain performance. Further studies are needed to evaluate the optimal oxygen levels for maximal brain performance.

Interactions of double patterning technology with wafer processing, OPC and design flows

NASA Astrophysics Data System (ADS)

Lucas, Kevin; Cork, Chris; Miloslavsky, Alex; Luk-Pat, Gerry; Barnes, Levi; Hapli, John; Lewellen, John; Rollins, Greg; Wiaux, Vincent; Verhaegen, Staf

2008-03-01

Double patterning technology (DPT) is one of the main options for printing logic devices with half-pitch less than 45nm; and flash and DRAM memory devices with half-pitch less than 40nm. DPT methods decompose the original design intent into two individual masking layers which are each patterned using single exposures and existing 193nm lithography tools. The results of the individual patterning layers combine to re-create the design intent pattern on the wafer. In this paper we study interactions of DPT with lithography, masks synthesis and physical design flows. Double exposure and etch patterning steps create complexity for both process and design flows. DPT decomposition is a critical software step which will be performed in physical design and also in mask synthesis. Decomposition includes cutting (splitting) of original design intent polygons into multiple polygons where required; and coloring of the resulting polygons. We evaluate the ability to meet key physical design goals such as: reduce circuit area; minimize rework; ensure DPT compliance; guarantee patterning robustness on individual layer targets; ensure symmetric wafer results; and create uniform wafer density for the individual patterning layers.

Randomized double-blind placebo-controlled trial of buccal misoprostol to reduce the need for additional uterotonic drugs during cesarean delivery.

PubMed

Hernández-Castro, Flavio; López-Serna, Norberto; Treviño-Salinas, Emilio M; Soria-López, Juan A; Sordia-Hernández, Luis H; Cárdenas-Estrada, Eloy

2016-02-01

To determine whether buccal misoprostol during cesarean delivery in conjunction with active management of the third stage of labor reduces the need for additional uterotonic drugs. A double-blind, randomized, placebo-controlled trial was performed in Monterrey, Mexico, between February 2008 and December 2013. Eligible women had risk factors for uterine atony and were to undergo cesarean delivery under epidural block. Using a computer-generated sequence and blocks of six, patients were randomly assigned to receive 400μg misoprostol or 800μg placebo buccally after cord clamping. Both groups received an intravenous oxytocin infusion. The primary outcome was the need for additional uterotonic drugs. Analyses were performed per protocol. Patients, investigators, and data analysts were masked to group assignment. A total of 120 women were included in analyses (60 in each group). At least one additional uterotonic drug was required in 24 (40%) women in the placebo group versus 6 (10%) women in the misoprostol group (relative risk 0.16; 95% confidence interval 0.06-0.44). No adverse effects due to misoprostol were recorded. Buccal misoprostol during cesarean delivery reduced the need for additional uterotonic drugs to treat uterine atony. ClinicalTrials.gov:NCT01733329. Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. 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.

Forward masking of frequency modulationa

PubMed Central

Byrne, Andrew J.; Wojtczak, Magdalena; Viemeister, Neal F.

2012-01-01

Forward masking of sinusoidal frequency modulation (FM) was measured with three types of maskers: FM, amplitude modulation (AM), and a masker created by combining the magnitude spectrum of an FM tone with random component phases. For the signal FM rates used (5, 20, and 40 Hz), an FM masker raised detection thresholds in terms of frequency deviation by a factor of about 5 relative to without a masker. The AM masker produced a much smaller effect, suggesting that FM-to-AM conversion did not contribute substantially to the FM forward masking. The modulation depth of an FM masker had a nonmonotonic effect, with maximal masking observed at an intermediate value within the range of possible depths, while the random-phase FM masker produced less masking, arguing against a spectrally-based explanation for FM forward masking. Broad FM-rate selectivity for forward masking was observed for both 4-kHz and 500-Hz carriers. Thresholds measured as a function of the masker-signal delay showed slow recovery from FM forward masking, with residual masking for delays up to 500 ms. The FM forward-masking effect resembles that observed for AM [Wojtczak and Viemeister (2005). J. Acoust. Soc. Am. 188, 3198–3210] and may reflect modulation-rate selective neural adaptation to FM. PMID:23145618

CARbon DIoxide for the treatment of Febrile seizures: rationale, feasibility, and design of the CARDIF-study

PubMed Central

2013-01-01

Background 2-8% of all children aged between 6 months and 5 years have febrile seizures. Often these seizures cease spontaneously, however depending on different national guidelines, 20-40% of the patients would need therapeutic intervention. For seizures longer than 3-5 minutes application of rectal diazepam, buccal midazolam or sublingual lorazepam is recommended. Benzodiazepines may be ineffective in some patients or cause prolonged sedation and fatigue. Preclinical investigations in a rat model provided evidence that febrile seizures may be triggered by respiratory alkalosis, which was subsequently confirmed by a retrospective clinical observation. Further, individual therapeutic interventions demonstrated that a pCO2-elevation via re-breathing or inhalation of 5% CO2 instantly stopped the febrile seizures. Here, we present the protocol for an interventional clinical trial to test the hypothesis that the application of 5% CO2 is effective and safe to suppress febrile seizures in children. Methods The CARDIF (CARbon DIoxide against Febrile seizures) trial is a monocentric, prospective, double-blind, placebo-controlled, randomized study. A total of 288 patients with a life history of at least one febrile seizure will be randomized to receive either carbogen (5% CO2 plus 95% O2) or placebo (100% O2). As recurrences of febrile seizures mainly occur at home, the study medication will be administered by the parents through a low-pressure can fitted with a respiratory mask. The primary outcome measure is the efficacy of carbogen to interrupt febrile seizures. As secondary outcome parameters we assess safety, practicability to use the can, quality of life, contentedness, anxiousness and mobility of the parents. Prospect The CARDIF trial has the potential to develop a new therapy for the suppression of febrile seizures by redressing the normal physiological state. This would offer an alternative to the currently suggested treatment with benzodiazepines. This study is an example of academic translational research from the study of animal physiology to a new therapy. Trial registration ClinicalTrials.gov identifier: NCT01370044 PMID:23806032

A Randomized Controlled Trial of Omega 3 Fatty Acids in Rosacea Patients with Dry Eye Symptoms.

PubMed

Bhargava, Rahul; Chandra, Mini; Bansal, Utsav; Singh, Divya; Ranjan, Somesh; Sharma, Shalini

2016-10-01

Objective or purpose: To evaluate the efficacy of dietary omega-3 fatty acids (O3FAs) in rosacea patients having dry eye symptoms. A prospective, interventional, randomized, double-masked, placebo-controlled, multi-centric study was done. Symptomatic patients with rosacea were recruited based on their response to (Dry Eye Scoring System, DESS©); a score of 0-3 was assigned to dry eye-related symptoms like ocular fatigue, blurring of vision, itching or burning, sandy or gritty sensation, and redness, respectively (DESS©). Subjects were (n = 130) were randomized to receive either O3FAs (n = 65) or placebo (n = 65) capsules (olive oil) twice daily for 6 months. Patients were evaluated at baseline, 1, 3, and 6 months. Change in subjective dry eye symptoms was the primary outcome measure. Change in meibomian gland score (MGS), Schirmer score, and tear film breakup time (TBUT) were the secondary outcome measures. Repeated-measures ANOVA revealed that there was a significant (p < 0.001) change in symptoms (F(1.506, 88.825 = 315.193), MGS (F(1.336, 78.796 = 84.438), Schirmer score (F(1.322, 78.022 = 86.559), and TBUT (F(1.354, 79.898 = 179.020.559) in O3FA group as compared to placebo group. Post-hoc test revealed that there was a significant change in dry eye symptoms at all points of time; there was a significant change in MGS, Schirmer score, and TBUT also, but only after 3 months of intervention. Linear regression established that symptom severity could significantly predict MGS, Schirmer score, and TBUT. There was a significant change in the slope (intercept) of the regression plots in O3FA group as compared to the placebo group. Rosacea patients with dry eye symptoms have significant improvement in symptoms, MGS, TBUT, and Schirmer score, following dietary intervention with O3FAs for 6 months.

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.

Two Phase 3 Clinical Trials Comparing the Safety and Efficacy of Netarsudil to Timolol in Patients With Elevated Intraocular Pressure: Rho Kinase Elevated IOP Treatment Trial 1 and 2 (ROCKET-1 and ROCKET-2).

PubMed

Serle, Janet B; Katz, L Jay; McLaurin, Eugene; Heah, Theresa; Ramirez-Davis, Nancy; Usner, Dale W; Novack, Gary D; Kopczynski, Casey C

2018-02-01

To evaluate the efficacy and ocular and systemic safety of netarsudil 0.02% ophthalmic solution, a rho-kinase inhibitor and norepinephrine transporter inhibitor, in patients with open-angle glaucoma and ocular hypertension. Double-masked, randomized noninferiority clinical trials: Rho Kinase Elevated IOP Treatment Trial 1 and 2 (ROCKET-1 and ROCKET-2). After a washout of all pre-study ocular hypotensive medications, eligible patients were randomized to receive netarsudil 0.02% once daily (q.d.), timolol 0.5% twice a day (b.i.d.), and (ROCKET-2 only) netarsudil 0.02% b.i.d. Data through 3 months from both studies are provided in this report. Enrolled into the 2 studies were 1167 patients. Treatment with netarsudil q.d. produced clinically and statistically significant reductions from baseline intraocular pressure (P < .001), and was noninferior to timolol in the per-protocol population with maximum baseline IOP < 25 mm Hg in both studies (ROCKET-2, primary outcome measure and population, ROCKET-1, post hoc outcome measure). Netarsudil b.i.d. was also noninferior to timolol (ROCKET-2). The most frequent adverse event was conjunctival hyperemia, the incidence of which ranged from 50% (126/251, ROCKET-2) to 53% (108/203, ROCKET-1) for netarsudil q.d., 59% (149/253, ROCKET-2) for netarsudil b.i.d., and 8% (17/208, ROCKET-1) to 11% (27/251, ROCKET-2) for timolol (P < .0001 for netarsudil vs timolol). In 2 large, randomized, double-masked trials reported here, once-daily dosing of netarsudil 0.02% was found to be effective and well tolerated for the treatment of patients with ocular hypertension and open-angle glaucoma. The novel pharmacology and aqueous humor dynamic effects of this molecule suggest it may be a useful addition to the armamentarium of ocular hypotensive medications. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

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.

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.

Universal Mask Usage for Reduction of Respiratory Viral Infections After Stem Cell Transplant: A Prospective Trial.

PubMed

Sung, Anthony D; Sung, Julia A M; Thomas, Samantha; Hyslop, Terry; Gasparetto, Cristina; Long, Gwynn; Rizzieri, David; Sullivan, Keith M; Corbet, Kelly; Broadwater, Gloria; Chao, Nelson J; Horwitz, Mitchell E

2016-10-15

Respiratory viral infections (RVIs) are frequent complications of hematopoietic stem cell transplant (HSCT). Surgical masks are a simple and inexpensive intervention that may reduce nosocomial spread. In this prospective single-center study, we instituted a universal surgical mask policy requiring all individuals with direct contact with HSCT patients to wear a surgical mask, regardless of symptoms or season. The primary endpoint was the incidence of RVIs in the mask period (2010-2014) compared with the premask period (2003-2009). RVIs decreased from 10.3% (95/920 patients) in the premask period to 4.4% (40/911) in the mask period (P < .001). Significant decreases occurred after both allogeneic (64/378 [16.9%] to 24/289 [8.3%], P = .001) and autologous (31/542 [5.7%] to 16/622 [2.6%], P = .007) transplants. After adjusting for multiple covariates including season and year in a segmented longitudinal analysis, the decrease in RVIs remained significant, with risk of RVI of 0.4 in patients in the mask group compared with the premask group (0.19-0.85, P = .02). In contrast, no decrease was observed during this same period in an adjacent hematologic malignancy unit, which followed the same infection control practices except for the mask policy. The majority of this decrease was in parainfluenza virus 3 (PIV3) (8.3% to 2.2%, P < .001). Requiring all individuals with direct patient contact to wear a surgical mask is associated with a reduction in RVIs, particularly PIV3, during the most vulnerable period following HSCT. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

Universal Mask Usage for Reduction of Respiratory Viral Infections After Stem Cell Transplant: A Prospective Trial

PubMed Central

Sung, Anthony D.; Sung, Julia A. M.; Thomas, Samantha; Hyslop, Terry; Gasparetto, Cristina; Long, Gwynn; Rizzieri, David; Sullivan, Keith M.; Corbet, Kelly; Broadwater, Gloria; Chao, Nelson J.; Horwitz, Mitchell E.

2016-01-01

Background. Respiratory viral infections (RVIs) are frequent complications of hematopoietic stem cell transplant (HSCT). Surgical masks are a simple and inexpensive intervention that may reduce nosocomial spread. Methods. In this prospective single-center study, we instituted a universal surgical mask policy requiring all individuals with direct contact with HSCT patients to wear a surgical mask, regardless of symptoms or season. The primary endpoint was the incidence of RVIs in the mask period (2010–2014) compared with the premask period (2003–2009). Results. RVIs decreased from 10.3% (95/920 patients) in the premask period to 4.4% (40/911) in the mask period (P < .001). Significant decreases occurred after both allogeneic (64/378 [16.9%] to 24/289 [8.3%], P = .001) and autologous (31/542 [5.7%] to 16/622 [2.6%], P = .007) transplants. After adjusting for multiple covariates including season and year in a segmented longitudinal analysis, the decrease in RVIs remained significant, with risk of RVI of 0.4 in patients in the mask group compared with the premask group (0.19–0.85, P = .02). In contrast, no decrease was observed during this same period in an adjacent hematologic malignancy unit, which followed the same infection control practices except for the mask policy. The majority of this decrease was in parainfluenza virus 3 (PIV3) (8.3% to 2.2%, P < .001). Conclusions. Requiring all individuals with direct patient contact to wear a surgical mask is associated with a reduction in RVIs, particularly PIV3, during the most vulnerable period following HSCT. PMID:27481873

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.

Concomitant or sequential administration of live attenuated Japanese encephalitis chimeric virus vaccine and yellow fever 17D vaccine: randomized double-blind phase II evaluation of safety and immunogenicity.

PubMed

Nasveld, Peter E; Marjason, Joanne; Bennett, Sonya; Aaskov, John; Elliott, Suzanne; McCarthy, Karen; Kanesa-Thasan, Niranjan; Feroldi, Emmanuel; Reid, Mark

2010-11-01

A randomized, double-blind, study was conducted to evaluate the safety, tolerability and immunogenicity of a live attenuated Japanese encephalitis chimeric virus vaccine (JE-CV) co-administered with live attenuated yellow fever vaccine (YF-17D strain; Stamaril®, Sanofi Pasteur) or administered successively. Participants (n = 108) were randomized to receive: YF followed by JE-CV 30 days later, JE followed by YF 30 days later, or the co-administration of JE and YF followed or preceded by placebo 30 days later or earlier. Placebo was used in a double-dummy fashion to ensure masking. Neutralizing antibody titers against JE-CV, YF-17D and selected wild-type JE strains was determined using a 50% serum-dilution plaque reduction neutralization test. Seroconversion was defined as the appearance of a neutralizing antibody titer above the assay cut-off post-immunization when not present pre-injection at day 0, or a least a four-fold rise in neutralizing antibody titer measured before the pre-injection day 0 and later post vaccination samples. There were no serious adverse events. Most adverse events (AEs) after JE vaccination were mild to moderate in intensity, and similar to those reported following YF vaccination. Seroconversion to JE-CV was 100% and 91% in the JE/YF and YF/JE sequential vaccination groups, respectively, compared with 96% in the co-administration group. All participants seroconverted to YF vaccine and retained neutralizing titers above the assay cut-off at month six. Neutralizing antibodies against JE vaccine were detected in 82-100% of participants at month six. These results suggest that both vaccines may be successfully co-administered simultaneously or 30 days apart.

Chuanhu Anti-Gout Mixture versus Colchicine for Acute Gouty Arthritis: A Randomized, Double-Blind, Double-Dummy, Non-Inferiority Trial

PubMed Central

Wang, YanGang; Wang, Luan; Li, EnZe; Li, Yang; Wang, ZhongChao; Sun, XiaoFang; Yu, XiaoLong; Ma, Lin; Wang, YunLong; Wang, YouXin

2014-01-01

Background The Chuanhu anti-gout mixture has been used for many years in the treatment of gout in Chinese Traditional Medicine, and current methods for treatments for acute gouty arthritis have been either less effective or have had serious side effects. Methods In this 12-week, double-blind, double-dummy, non-inferiority study, outpatient individuals with newly diagnosed acute gouty arthritis were randomly assigned to receive Chuanhu anti-gout mixture or colchicine. Both the study investigators and the participants were masked to the treatment assignments. The primary outcome was the recurrence rate of acute gouty arthritis, and the secondary outcomes were changes in white blood cells (WHC) and C-reactive protein (CRP). This trial is registered at ISRCTN.org as trial ISRCTN65219941. Results A total of 176 patients were randomly assigned to receive either the Chuanhu anti-gout mixture or Colchicine. The overall recurrence rates in the Chuanhu anti-gout mixture group (CH group) and the Colchicine group (Col group) were 12.50% vs 14.77% (difference -2.22%, 95% confidence interval (95% CI): -10.78%~6.23%), meeting the predefined non-inferiority criterion of 15%, as did the data for WHC and CRP. The incidence of adverse events (mainly diarrhea) was less in the Col group than in the CH group (2.27% vs 28.41%, 95% CI 0.01~0.26). In addition, changes in blood uric acid, alanine aminotransferase, aspartate aminotransferase and creatinine in the CH group were significantly larger compared to those in the Col group (P<0.05). Conclusions The Chuanhu anti-gout mixture was non-inferior to colchicine for the treatment of acute gouty arthritis. The study suggested that the Chuanhu anti-gout mixture can be considered an alternative choice for the treatment of acute gouty arthritis because of its lower incidence of adverse events and its protection of kidney and renal function. PMID:25013367

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.

Effect of warming bupivacaine 0.5% on ultrasound-guided axillary plexus block. Randomized prospective double-blind study.

PubMed

Trabelsi, W; Ben Gabsia, A; Lebbi, A; Sammoud, W; Labbène, I; Kchelfi, S; Ferjani, M

2017-02-01

To evaluate the effect of warming bupivacaine 0.5% on ultrasound-guided axillary brachial plexus block. Prospective, randomized, double-blind. Eighty patients undergoing elective or emergency surgery beyond the distal third of the upper limb were divided into two groups of 40 patients: the warm group received 15mL bupivacaine 0.5% heated to 37°C; the cold group received 15mL 0.5% bupivacaine stored for at least 24hours in the lower compartment of a refrigerator at 13-15°C. Onset and duration of sensory and motor blocks were evaluated every 5minutes for 40minutes. Postoperative pain was evaluated at 1, 3, 6, 12 and 24hours. Effective analgesia time was recorded as the interval between anesthetic injection and the first analgesia requirement (VAS>30mm). Time to onset of sensory and motor block was significantly shorter in the warm group, and mean duration of sensory and motor block and of postoperative analgesia significantly longer. Warming bupivacaine 0.5% to 37°C accelerated onset of sensory and motor block and extended action duration. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Comparison of Effect of Oral Premedication with Ibuprofen or Dexamethasone on Anesthetic Efficacy of Inferior Alveolar Nerve Block in Patients with Irreversible Pulpitis: A Prospective, Randomized, Controlled, Double-blind Study.

PubMed

Bidar, Maryam; Mortazavi, Soheil; Forghani, Maryam; Akhlaghi, Saeed

2017-01-01

The purpose of this prospective, randomized, double-blind, placebo-controlled study was to determine the effect of preoperative oral administration of ibuprofen or dexamethasone on the success rate of inferior alveolar nerve block (IANB) in patients with symptomatic irreversible pulpitis. Seventy-eight patients with irreversible pulpitis were randomly divided into 3 groups (26 per group) and given one of the following at 1 hr prior to performing local anesthesia: a placebo; 400 mg ibuprofen; or 4 mg dexamethasone. Each patient recorded their pain level on a visual analog scale before taking the medication or placebo, at 15 min after completion of IANB, and during treatment if pain occurred. The success of the anesthesia was defined as no or mild pain at any stage during the endodontic procedure. The success rate of the IANB was 38.5, 73.1, and 80.8% with the placebo, ibuprofen, and dexamethasone, respectively. Both ibuprofen and dexamethasone were significantly more effective than the placebo. No significant difference was observed, however, between the two experimental medications in terms of effectiveness. The results of the present study suggest that premedication with ibuprofen or dexamethasone increases the success rate of an IANB in patients with symptomatic irreversible pulpitis in the mandibular molars.

Combination of arginine, glutamine, and omega-3 fatty acid supplements for perioperative enteral nutrition in surgical patients with gastric adenocarcinoma or gastrointestinal stromal tumor (GIST): A prospective, randomized, double-blind study.

PubMed

Ma, C; Tsai, H; Su, W; Sun, L; Shih, Y; Wang, J

2018-05-31

Perioperative enteral nutrition (EN) enriched with immune-modulating substrates is preferable for patients undergoing major abdominal cancer surgery. In this study, perioperative EN enriched with immune-modulating nutrients such as arginine, glutamine, and omega-3 fatty acids was evaluated for its anti-inflammatory efficacy in patients with gastric adenocarcinoma or gastrointestinal stromal tumor (GIST) receiving curative surgery. This prospective, randomized, double-blind study recruited 34 patients with gastric adenocarcinoma or gastric GIST undergoing elective curative surgery. These patients were randomly assigned to the study group, receiving immune-modulating nutrient-enriched EN, or the control group, receiving standard EN from 3 days before surgery (preoperative day 3) to up to postoperative day 14 or discharge. Laboratory and inflammatory parameters were assessed on preoperative day 3 and postoperative day 14 or at discharge. Adverse events (AEs) and clinical outcomes were documented daily and compared between groups. No significant differences were observed between the two groups in selected laboratory and inflammatory parameters, or in their net change, before and after treatment. AEs and clinical outcomes, including infectious complications, overall complications, time to first bowel action, and length of hospital stay after surgery, were comparable between treatment groups (all P > 0.05). Immune-modulating nutrient-enriched EN had no prominent immunomodulation effect compared with that of standard EN.

Safety and efficacy of cocoa flavanol intake in healthy adults: a randomized, controlled, double-masked trial.

PubMed

Ottaviani, Javier I; Balz, Marion; Kimball, Jennifer; Ensunsa, Jodi L; Fong, Reedmond; Momma, Tony Y; Kwik-Uribe, Catherine; Schroeter, Hagen; Keen, Carl L

2015-12-01

Evidence from dietary intervention studies shows that the intake of flavanols and procyanidins can be beneficial for cardiovascular health. Nevertheless, there is a clear need for advancing our understanding with regard to safe amounts of intake for these bioactives. The aim was to investigate in healthy adults the effects of cocoa flavanol (CF) intake amount and intake duration on blood pressure, platelet function, metabolic variables, and potential adverse events (AEs). This investigation consisted of 2 parts. Part 1 was an open-label, intake-amount escalation study, in which 34 healthy adults (aged 35-55 y) consumed escalating amounts of CFs, ranging from 1000 to 2000 mg/d over 6 wk. Primary outcomes were blood pressure and platelet function, select metabolic variables, and the occurrence and severity of AEs. Secondary outcomes included plasma concentrations of CF-derived metabolites and methylxanthines. On the basis of the outcomes of study part 1, and assessing the same outcome measures, part 2 of this investigation was a controlled, randomized, double-masked, 2-parallel-arm dietary intervention study in which healthy participants (aged 35-55 y) were asked to consume for 12 consecutive weeks up to 2000 mg CFs/d (n = 46) or a CF-free control (n = 28). Daily intake of up to 2000 mg CFs/d for 12 wk was not associated with significant changes in blood pressure or platelet function compared with CF-free controls in normotensive, healthy individuals who exhibited a very low risk of cardiovascular disease. There were no clinically relevant changes in the metabolic variables assessed in either of the groups. AEs reported were classified as mild in severity and did not significantly differ between study arms. The consumption of CFs in amounts up to 2000 mg/d for 12 wk was well tolerated in healthy men and women. This trial was registered at clinicaltrials.gov as NCT02447770 (part 1) and NCT02447783 (part 2). © 2015 American Society for Nutrition.

Time-dependent effects of safflower oil to improve glycemia, inflammation and blood lipids in obese, post-menopausal women with type 2 diabetes: a randomized, double-masked, crossover study.

PubMed

Asp, Michelle L; Collene, Angela L; Norris, Leigh E; Cole, Rachel M; Stout, Michael B; Tang, Szu-Yu; Hsu, Jason C; Belury, Martha A

2011-08-01

Metabolic effects of dietary fat quality in people with type 2 diabetes are not well-understood. The study objective was to evaluate effects of conjugated linoleic acid (CLA) and safflower (SAF) oils on glycemia, blood lipids, and inflammation. The hypothesis we tested is that dietary oils improve glycemia, lipids, and inflammatory markers in a time-dependent way that follows accumulation of linoleic acid and CLA isomers in serum of subjects supplemented with dietary oils. Fifty-five post-menopausal, obese women with type 2 diabetes enrolled, and 35 completed this randomized, double-masked crossover study. Treatments were 8 g daily of CLA and SAF for 16 weeks each. We used a multiple testing procedure with pre-determined steps analysis to determine the earliest time that a significant effect was detected. CLA did not alter measured metabolic parameters. SAF decreased HbA1c (-0.64 ± 0.18%, p = 0.0007) and C-reactive protein (-13.6 ± 8.2 mg/L, p = 0.0472), increased QUICKI (0.0077 ± 0.0035, p = 0.0146) with a minimum time to effect observed 16 weeks after treatment. SAF increased HDL cholesterol (0.12 ± 0.05 mmol/L, p = 0.0228) with the minimum time to detect an effect of SAF at 12 weeks. The minimum time to detect an increase of c9t11-CLA, t10c12-CLA, and linoleic acid in serum of women supplemented CLA or SAF, respectively, was four weeks. We conclude that 8 g of SAF daily improved glycemia, inflammation, and blood lipids, indicating that small changes in dietary fat quality may augment diabetes treatments to improve risk factors for diabetes-related complications. Copyright © 2011 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Time-dependent effects of safflower oil to improve glycemia, inflammation and blood lipids in obese, post-menopausal women with type 2 diabetes: a randomized, double-masked, crossover study

PubMed Central

Asp, Michelle L.; Collene, Angela L.; Norris, Leigh E.; Cole, Rachel M.; Stout, Michael B.; Tang, Szu-Yu; Hsu, Jason C.; Belury, Martha A.

2011-01-01

Background & Aims Metabolic effects of dietary fat quality in people with type 2 diabetes are not well-understood. The study objective was to evaluate effects of conjugated linoleic acid (CLA) and safflower (SAF) oils on glycemia, blood lipids, and inflammation. The hypothesis we tested is SAF oil improves glycemic and inflammatory markers in a time dependent way that follows accumulation of linoleic acid and CLA isomers in serum of subjects supplemented with dietary oils. Methods Fifty-five post-menopausal, obese women with type 2 diabetes enrolled, and 35 completed this randomized, double-masked crossover study. Treatments were eight grams daily of CLA and SAF for 16 weeks each. We used a multiple testing procedure with predetermined step analysis to determine when the earliest time to effect was significant. Results CLA did not alter measured metabolic parameters. SAF decreased HbA1c (−0.64±0.18%, p<0.0007) and C-reactive protein (−13.6±8.2mg/L, p<0.0472), increased QUICKI (0.0077±0.0035, p<0.0146) with a minimum time to effect observed 16 weeks after treatment. SAF increased HDL cholesterol (0.12±0.05mmol/L, p<0.0228) with the minimum time to detect an effect of SAF at 12 weeks. The minimum time to detect an increase of c9t11-CLA, t10c12-CLA and linoleic acid in serum of women supplemented CLA or SAF respectively was four weeks. Conclusions We conclude that eight grams of SAF daily improved glycemia, inflammation, and blood lipids indicating that small changes in dietary fat quality may augment diabetes treatments to improve risk factors for diabetes-related complications. PMID:21295383

Methylxanthines enhance the effects of cocoa flavanols on cardiovascular function: randomized, double-masked controlled studies.

PubMed

Sansone, Roberto; Ottaviani, Javier I; Rodriguez-Mateos, Ana; Heinen, Yvonne; Noske, Dorina; Spencer, Jeremy P; Crozier, Alan; Merx, Marc W; Kelm, Malte; Schroeter, Hagen; Heiss, Christian

2017-02-01

Cocoa flavanol intake, especially that of (-)-epicatechin, has been linked to beneficial effects on human cardiovascular function. However, cocoa also contains the methylxanthines theobromine and caffeine, which may also affect vascular function. We sought to determine whether an interaction between cocoa flavanols and methylxanthines exists that influences cocoa flavanol-dependent vascular effects. Test drinks that contained various amounts of cocoa flavanols (0-820 mg) and methylxanthines (0-220 mg), either together or individually, were consumed by healthy volunteers (n = 47) in 4 different clinical studies-3 with a randomized, double-masked crossover design and 1 with 4 parallel crossover studies. Vascular status was assessed by measuring flow-mediated vasodilation (FMD), brachial pulse wave velocity (bPWV), circulating angiogenic cells (CACs), and blood pressure before and 2 h after the ingestion of test drinks. Although cocoa flavanol intake increased FMD 2 h after intake, the consumption of cocoa flavanols with methylxanthines resulted in a greater enhancement of FMD. Methylxanthine intake alone did not result in statistically significant changes in FMD. Cocoa flavanol ingestion alone decreased bPWV and diastolic blood pressure and increased CACs. Each of these changes was more pronounced when cocoa flavanols and methylxanthines were ingested together. It is important to note that the area under the curve of the plasma concentration of (-)-epicatechin metabolites over time was higher after the co-ingestion of cocoa flavanols and methylxanthines than after the intake of cocoa flavanols alone. Similar results were obtained when pure (-)-epicatechin and the methylxanthines theobromine and caffeine were consumed together. A substantial interaction between cocoa flavanols and methylxanthines exists at the level of absorption, in which the methylxanthines mediate an increased plasma concentration of (-)-epicatechin metabolites that coincides with enhanced vascular effects commonly ascribed to cocoa flavanol intake. This trial was registered at clinicaltrials.gov as NCT02149238. © 2017 American Society for Nutrition.

Effect of Sodium Bicarbonate Buccal Infiltration on the Success of Inferior Alveolar Nerve Block in Mandibular First Molars with Symptomatic Irreversible Pulpitis: A Prospective, Randomized Double-blind Study.

PubMed

Saatchi, Masoud; Farhad, Ali Reza; Shenasa, Naghmeh; Haghighi, Saeideh Karimi

2016-10-01

The purpose of this prospective, randomized, double-blind study was to evaluate the effect of a buccal infiltration of sodium bicarbonate on the anesthetic success of the inferior alveolar nerve block (IANB) for mandibular first molars in patients with symptomatic irreversible pulpitis. One hundred patients diagnosed with symptomatic irreversible pulpitis of a mandibular first molar were selected. The patients randomly received a buccal infiltration injection of either 0.7 mL 8.4% sodium bicarbonate with 0.3 mL 2% lidocaine containing 1:80,000 epinephrine or 0.7 mL sterile distilled water with 0.3 mL 2% lidocaine containing 1:80,000 epinephrine in a double-blind manner. After 15 minutes, all the patients received conventional IANB injection using 3.6 mL 2% lidocaine with 1:80,000 epinephrine. Access cavity preparation was initiated 15 minutes after the IANB injection. Lip numbness was a requisite for all the patients. Success was determined as no or mild pain on the basis of Heft-Parker visual analog scale recordings upon access cavity preparation or initial instrumentation. Data were analyzed using the t, chi-square and Mann-Whitney U tests. The success rate after the buccal infiltration of sodium bicarbonate was 78%, whereas without the buccal infiltration of sodium bicarbonate it was 44% (P < .001). A buccal infiltration of 0.7 mL 8.4% sodium bicarbonate increased the success rate of IANBs in mandibular first molars with symptomatic irreversible pulpitis. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Does acetaminophen/hydrocodone affect cold pulpal testing in patients with symptomatic irreversible pulpitis? A prospective, randomized, double-blind, placebo-controlled study.

PubMed

Fowler, Sara; Fullmer, Spencer; Drum, Melissa; Reader, Al

2014-12-01

The purpose of this prospective randomized, double-blind, placebo-controlled study was to determine the effects of a combination dose of 1000 mg acetaminophen/10 mg hydrocodone on cold pulpal testing in patients experiencing symptomatic irreversible pulpitis. One hundred emergency patients in moderate to severe pain diagnosed with symptomatic irreversible pulpitis of a mandibular posterior tooth randomly received, in a double-blind manner, identical capsules of either a combination of 1000 mg acetaminophen/10 hydrocodone or placebo. Cold testing with Endo-Ice (1,1,1,2 tetrafluoroethane; Hygenic Corp, Akron, OH) was performed at baseline and every 10 minutes for 60 minutes. Pain to cold testing was recorded by the patient using a Heft-Parker visual analog scale. Patients' reaction to the cold application was also rated. Cold testing at baseline and at 10 minutes resulted in severe pain for both the acetaminophen/hydrocodone and placebo groups. Although pain ratings decreased from 20-60 minutes, the ratings still resulted in moderate pain. Patient reaction to cold testing showed that 56%-62% had a severe reaction. Although the reactions decreased in severity over the 60 minutes, 20%-34% still had severe reactions at 60 minutes. Regarding pain and patients' reactions to cold testing, there were no significant differences between the combination acetaminophen/hydrocodone and placebo groups at any time period. A combination dose of 1000 mg of acetaminophen/10 mg of hydrocodone did not statistically affect cold pulpal testing in patients presenting with symptomatic irreversible pulpitis. Patients experienced moderate to severe pain and reactions to cold testing. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

A prospective randomized study for efficacy of an uncovered double bare metal stent compared to a single bare metal stent in malignant biliary obstruction.

PubMed

Lee, Hyun Jik; Chung, Moon Jae; Park, Jeong Yup; Park, Seung Woo; Nam, Chung Mo; Song, Si Young; Bang, Seungmin

2017-08-01

A biliary self-expandable metal stent (SEMS) is commonly used to relieve malignant biliary obstruction. The aim of this study was to compare the efficacy of a conventional uncovered SEMS with that of a newly developed uncovered double bare metal stent in reducing the risk of stent occlusion caused by tumor ingrowth. We performed a prospective, open-labeled, randomized trial in 71 patients at Severance Hospital, Yonsei University College of Medicine from June 2013 to June 2014. Patients with inoperable malignant biliary obstruction were included and randomized to receive an uncovered single bare metal stent (SBSs; S&G Biotech Inc.), an uncovered single bare metal stent (SBSt; Taewoong Medical), or an uncovered double bare metal stent (DBS; S&G Biotech Inc.). The mean age was 66.6 years (range, 35-83), and 42 (59.2%) were male. The mean duration of stent patency was 212 days (±152) in the DBS group (n = 24) compared with 124 days (±98) in the SBSs group (n = 23; P = 0.022 for noninferiority) and 116 days (±79) in the SBSt group (n = 24; P = 0.010 for noninferiority). There were no differences in the incidences of early and delayed complications or migration. The newly developed DBS is noninferior to the conventional uncovered SEMSs on duration of stent patency and tumor ingrowth occurred less frequently in the DBS group. This might decrease the need for reintervention and offer a better quality of life. The trial is registered with Clinicaltrials.gov no: NCT01869894.

A Prospective, Randomized, Double-Blind Comparison of 2% Lidocaine With 1 : 100,000 Epinephrine, 4% Prilocaine With 1 : 200,000 Epinephrine, and 4% Prilocaine for Maxillary Infiltrations

PubMed Central

Katz, Steven; Drum, Melissa; Reader, Al; Nusstein, John; Beck, Mike

2010-01-01

Abstract The purpose of this prospective, randomized, double-blind crossover study was to evaluate the anesthetic efficacy of 2% lidocaine with 1 : 100,000 epinephrine, 4% prilocaine with 1 : 200,000 epinephrine, and 4% prilocaine in maxillary lateral incisors and first molars. Sixty subjects randomly received, in a double-blind manner, maxillary lateral incisor and first molar infiltrations of 1.8 mL of 2% lidocaine with 1 : 100,000 epinephrine, 1.8 mL of 4% prilocaine with 1 : 200,000 epinephrine, and 1.8 mL of 4% prilocaine, at 3 separate appointments spaced at least 1 week apart. The teeth were pulp-tested in 3-minute cycles for a total of 60 minutes. Anesthetic success (ie, obtaining 2 consecutive 80 readings with the electric pulp tester) and onset of pulpal anesthesia were not significantly different between 2% lidocaine with 1 : 100,000 epinephrine, 4% prilocaine with 1 : 200,000 epinephrine, and 4% prilocaine for the lateral incisor and first molar. For both lateral incisor and first molar, 4% prilocaine with 1 : 200,000 epinephrine and 2% lidocaine with 1 : 100,000 epinephrine were equivalent for incidence of pulpal anesthesia. However, neither anesthetic agent provided an hour of pulpal anesthesia. For both lateral incisor and first molar, 4% prilocaine provided a significantly shorter duration of pulpal anesthesia compared with 2% lidocaine with 1 : 100,000 epinephrine and 4% prilocaine with 1 : 200,000 epinephrine. PMID:20553134

Power spectrum model of visual masking: simulations and empirical data.

PubMed

Serrano-Pedraza, Ignacio; Sierra-Vázquez, Vicente; Derrington, Andrew M

2013-06-01

In the study of the spatial characteristics of the visual channels, the power spectrum model of visual masking is one of the most widely used. When the task is to detect a signal masked by visual noise, this classical model assumes that the signal and the noise are previously processed by a bank of linear channels and that the power of the signal at threshold is proportional to the power of the noise passing through the visual channel that mediates detection. The model also assumes that this visual channel will have the highest ratio of signal power to noise power at its output. According to this, there are masking conditions where the highest signal-to-noise ratio (SNR) occurs in a channel centered in a spatial frequency different from the spatial frequency of the signal (off-frequency looking). Under these conditions the channel mediating detection could vary with the type of noise used in the masking experiment and this could affect the estimation of the shape and the bandwidth of the visual channels. It is generally believed that notched noise, white noise and double bandpass noise prevent off-frequency looking, and high-pass, low-pass and bandpass noises can promote it independently of the channel's shape. In this study, by means of a procedure that finds the channel that maximizes the SNR at its output, we performed numerical simulations using the power spectrum model to study the characteristics of masking caused by six types of one-dimensional noise (white, high-pass, low-pass, bandpass, notched, and double bandpass) for two types of channel's shape (symmetric and asymmetric). Our simulations confirm that (1) high-pass, low-pass, and bandpass noises do not prevent the off-frequency looking, (2) white noise satisfactorily prevents the off-frequency looking independently of the shape and bandwidth of the visual channel, and interestingly we proved for the first time that (3) notched and double bandpass noises prevent off-frequency looking only when the noise cutoffs around the spatial frequency of the signal match the shape of the visual channel (symmetric or asymmetric) involved in the detection. In order to test the explanatory power of the model with empirical data, we performed six visual masking experiments. We show that this model, with only two free parameters, fits the empirical masking data with high precision. Finally, we provide equations of the power spectrum model for six masking noises used in the simulations and in the experiments.

Herd protection effect of N95 respirators in healthcare workers.

PubMed

Chen, Xin; Chughtai, Abrar Ahmad; MacIntyre, Chandini Raina

2017-12-01

Objective To determine if there was herd protection conferred to unprotected healthcare workers (HCWs) by N95 respirators worn by colleagues. Methods Data were analysed from a prospective cluster randomized clinical trial conducted in Beijing, China between 1 December 2008 and 15 January 2009. A minimum compliance level (MCL) of N95 respirators for prevention of clinical respiratory illness (CRI) was set based on various compliance cut-offs. The CRI rates were compared between compliant (≥MCL) and non-compliant (

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.

Rocuronium versus vecuronium during fentanyl induction in patients undergoing coronary artery surgery.

PubMed

Smith, C E; Botero, C; Holbrook, C; Pinchak, A C; Hagen, J F

1999-10-01

To evaluate the neuromuscular, ventilatory, and cardiovascular effects of rocuronium and vecuronium. Randomized, prospective, blinded study. Tertiary care teaching center, single institution. Patients undergoing elective coronary artery bypass graft procedure. Patients received rocuronium, 1.0 mg/kg (n = 17), or vecuronium, 0.15 mg/kg (n = 15), during fentanyl induction of anesthesia. Measures consisted of time to visual loss of orbicularis oculi twitches in response to facial nerve stimulation, ease of mask ventilation, hemodynamics, need for vasoactive drugs, and tracheal intubating conditions. Median time to twitch loss was faster (p < 0.05) after rocuronium (60 s) than after vecuronium (>84 s). Within 45 seconds, only 3 of 17 patients in the rocuronium group had moderate-to-severe difficulty with mask ventilation versus 12 of 15 patients in the vecuronium group (p < 0.05). Tracheal intubating conditions were excellent in all patients after rocuronium. In the vecuronium group, intubating conditions were excellent in 46%, good in 27%, and poor in 27% (p < 0.05 vrocuronium). Patients receiving vecuronium were more likely to require ephedrine and phenylephrine for hypotension (10/15 patients v 5/17 patients for rocuronium, p < 0.05). There were no clinically important differences in hemodynamic variables, oxygen metabolism, or myocardial ischemia between groups. During narcotic induction of anesthesia, rocuronium was associated with lower requirement for vasopressors, faster onset of neuromuscular blockade, and better conditions for mask ventilation and tracheal intubation compared with vecuronium.

Evaluation of the Efficacy of Tranexamic Acid on the Surgical Field in Primary Cleft Palate Surgery on Children-A Prospective, Randomized Clinical Study.

PubMed

Durga, Padmaja; Raavula, Parvathi; Gurajala, Indira; Gunnam, Poojita; Veerabathula, Prardhana; Reddy, Mukund; Upputuri, Omkar; Ramachandran, Gopinath

2015-09-01

To assess the effect of tranexamic acid on the quality of the surgical field. Prospective, randomized, double-blind study. Institutional, tertiary referral hospital. American Society of Anesthesiologists physical status class I patients, aged 8 to 60 months with Group II or III (Balakrishnan's classification) clefts scheduled for cleft palate repair. Children were randomized into two groups. The control group received saline, and the tranexamic acid group received tranexamic acid 10 mg/kg as a bolus, 15 minutes before incision. Grade of surgical field on a 10-point scale, surgeon satisfaction, and primary hemorrhage. Significant improvements were noted in surgeon satisfaction and median grade of assessment of the surgical field (4 [interquartile range, 4 to 6] in the control group vs. 3 [interquartile range, 2 to 4] in the test group; P = .003) in the tranexamic acid group compared to the control group. Preincision administration of 10 mg/kg of tranexamic acid significantly improved the surgical field during cleft palate repair.

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.

Iris colour, ethnic origin and progression of age-related macular degeneration.

PubMed

Nicolas, Caroline M; Robman, Luba D; Tikellis, Gabriella; Dimitrov, Peter N; Dowrick, Adam; Guymer, Robyn H; McCarty, Catherine A

2003-12-01

To investigate the relationship between iris colour, ethnic origin and the progression of age-related macular degeneration (AMD). Participants were recruited from the population-based Melbourne Visual Impairment Project or the prospective, randomized, double-masked Vitamin E, Cataract and Age-Related Macular Degeneration study. From these two cohorts, 171 participants aged between 52 and 93 years who were identified as having early AMD features at their baseline examination (1992-1995) were followed for an average of 6.8 years (until 2001) to determine the progression rate of early AMD. The participants' iris colour was categorized as light, intermediate or dark. Ethnic origin was categorized as Anglo-Saxon or non-Anglo-Saxon, according to the participants' grandparents' country of birth. In total, 53 (31%) of the 171 participants showed signs of AMD progression. Participants with light iris colour had twofold the risk of AMD progression of those with dark or intermediate iris colours, although the age-adjusted and multivariate-adjusted associations were not significant (both P = 0.13). Age-adjusted and multivariate comparisons of Anglo-Saxon ethnic origin to non-Anglo-Saxon ethnic origin showed a noticeable but non-significant association with progression of AMD (P= 0.22 and P= 0.14, respectively). Individuals with light iris colour or of Anglo-Saxon ethnic origin had a strong tendency to greater progression of AMD. A larger sample is required to confirm these clinically important, but statistically non-significant, associations.

Hospital cost analysis of a prospective, randomized trial of early vs interval appendectomy for perforated appendicitis in children.

PubMed

Myers, Adrianne L; Williams, Regan F; Giles, Kim; Waters, Teresa M; Eubanks, James W; Hixson, S Douglas; Huang, Eunice Y; Langham, Max R; Blakely, Martin L

2012-04-01

The methods of surgical care for children with perforated appendicitis are controversial. Some surgeons prefer early appendectomy; others prefer initial nonoperative management followed by interval appendectomy. Determining which of these two therapies is most cost-effective was the goal of this study. We conducted a prospective, randomized trial in children with a preoperative diagnosis of perforated appendicitis. Patients were randomized to early or interval appendectomy. Overall hospital costs were extracted from the hospital's internal cost accounting system and the two treatment groups were compared using an intention-to-treat analysis. Nonparametric data were reported as median ± standard deviation (or range) and compared using a Wilcoxon rank sum test. One hundred thirty-one patients were randomized to either early (n = 64) or interval (n = 67) appendectomy. Hospital charges and costs were significantly lower in patients randomized to early appendectomy. Total median hospital costs were $17,450 (range $7,020 to $55,993) for patients treated with early appendectomy vs $22,518 (range $4,722 to $135,338) for those in the interval appendectomy group. Median hospital costs more than doubled in patients who experienced an adverse event ($15,245 vs $35,391, p < 0.0001). Unplanned readmissions also increased costs significantly and were more frequent in patients randomized to interval appendectomy. In a prospective randomized trial, hospital charges and costs were significantly lower for early appendectomy when compared with interval appendectomy. The increased costs were related primarily to the significant increase in adverse events, including unplanned readmissions, seen in the interval appendectomy group. Copyright © 2012. Published by Elsevier Inc.

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.

Complications and Adverse Events of a Randomized Clinical Trial Comparing 3 Graft Types for ACL Reconstruction.

PubMed

Mohtadi, Nicholas; Barber, Rhamona; Chan, Denise; Paolucci, Elizabeth Oddone

2016-05-01

Complications/adverse events of anterior cruciate ligament (ACL) surgery are underreported, despite pooled level 1 data in systematic reviews. All adverse events/complications occurring within a 2-year postoperative period after primary ACL reconstruction, as part of a large randomized clinical trial (RCT), were identified and described. Prospective, double-blind randomized clinical trial. Patients and the independent trained examiner were blinded to treatment allocation. University-based orthopedic referral practice. Three hundred thirty patients (14-50 years; 183 males) with isolated ACL deficiency were intraoperatively randomized to ACL reconstruction with 1 autograft type. Graft harvest and arthroscopic portal incisions were identical. Patients were equally distributed to patellar tendon (PT), quadruple-stranded hamstring tendon (HT), and double-bundle (DB) hamstring autograft ACL reconstruction. Adverse events/complications were patient reported, documented, and diagnoses confirmed. Two major complications occurred: pulmonary embolism and septic arthritis. Twenty-four patients (7.3%) required repeat surgery, including 25 separate operations: PT = 7 (6.4%), HT = 9 (8.2%), and DB = 8 (7.3%). Repeat surgery was performed for meniscal tears (3.6%; n = 12), intra-articular scarring (2.7%; n = 9), chondral pathology (0.6%; n = 2), and wound dehiscence (0.3%; n = 1). Other complications included wound problems, sensory nerve damage, muscle tendon injury, tibial periostitis, and suspected meniscal tears and chondral lesions. Overall, more complications occurred in the HT/DB groups (PT = 24; HT = 31; DB = 45), but more PT patients complained of moderate or severe kneeling pain (PT = 17; HT = 9; DB = 4) at 2 years. Overall, ACL reconstructive surgery is safe. Major complications were uncommon. Secondary surgery was necessary 7.3% of the time for complications/adverse events (excluding graft reinjury or revisions) within the first 2 years. Level 1 (therapeutic studies). This article reports on the complications/adverse events that were prospectively identified up to 2 years postoperatively, in a defined patient population participating in a large double-blind randomized clinical trial comparing PT, single-bundle hamstring, and DB hamstring reconstructions for ACL rupture.

Randomized crossover clinical trial of real and sham peripheral prism glasses for hemianopia

PubMed Central

Bowers, Alex R.; Keeney, Karen; Peli, Eli

2013-01-01

Objective To evaluate the efficacy of real relative to sham peripheral prism glasses for patients with complete homonymous hemianopia and without visual neglect. Methods Patients recruited at 13 clinics were allocated by minimization into a double-masked, crossover trial with two groups. One group received real (57Δ) oblique and sham (≤ 5Δ) horizontal prisms; the other received real horizontal and sham oblique, in counterbalanced order. A masked data collector at each clinic administered questionnaires after each 4-week crossover period. Main outcome measure The primary outcome was the overall difference, across the two periods of the crossover, between the proportion of participants who wanted to continue with (said “yes” to) real prisms and the proportion who said yes to sham prisms. The secondary outcome was the difference in perceived mobility improvement between real and sham prisms. Results Of 73 patients randomized, 61 completed the crossover. A significantly higher proportion said yes to real than sham prisms (64% vs. 36%; odds ratio 5.3, 95% CI 1.8 to 21.0). Participants who continued wear after 6 months reported greater improvement in mobility with real than sham prisms at crossover end (p=0.002); participants who discontinued wear reported no difference. Conclusion Real peripheral prism glasses were more helpful for obstacle avoidance when walking than sham glasses, with no differences between the horizontal and oblique designs. Applications to clinical practice Peripheral prism glasses provide a simple and inexpensive mobility rehabilitation intervention for hemianopia. PMID:24201760

Morinda citrifolia (Noni) as an Anti-Inflammatory Treatment in Women with Primary Dysmenorrhoea: A Randomised Double-Blind Placebo-Controlled Trial.

PubMed

Fletcher, H M; Dawkins, J; Rattray, C; Wharfe, G; Reid, M; Gordon-Strachan, G

2013-01-01

Introduction. Noni (Morinda citrifolia) has been used for many years as an anti-inflammatory agent. We tested the efficacy of Noni in women with dysmenorrhea. Method. We did a prospective randomized double-blind placebo-controlled trial in 100 university students of 18 years and older over three menstrual cycles. Patients were invited to participate and randomly assigned to receive 400 mg Noni capsules or placebo. They were assessed for baseline demographic variables such as age, parity, and BMI. They were also assessed before and after treatment, for pain, menstrual blood loss, and laboratory variables: ESR, hemoglobin, and packed cell volume. Results. Of the 1027 women screened, 100 eligible women were randomized. Of the women completing the study, 42 women were randomized to Noni and 38 to placebo. There were no significant differences in any of the variables at randomization. There were also no significant differences in mean bleeding score or pain score at randomization. Both bleeding and pain scores gradually improved in both groups as the women were observed over three menstrual cycles; however, the improvement was not significantly different in the Noni group when compared to the controls. Conclusion. Noni did not show a reduction in menstrual pain or bleeding when compared to placebo.

Morinda citrifolia (Noni) as an Anti-Inflammatory Treatment in Women with Primary Dysmenorrhoea: A Randomised Double-Blind Placebo-Controlled Trial

PubMed Central

Fletcher, H. M.; Dawkins, J.; Rattray, C.; Wharfe, G.; Reid, M.; Gordon-Strachan, G.

2013-01-01

Introduction. Noni (Morinda citrifolia) has been used for many years as an anti-inflammatory agent. We tested the efficacy of Noni in women with dysmenorrhea. Method. We did a prospective randomized double-blind placebo-controlled trial in 100 university students of 18 years and older over three menstrual cycles. Patients were invited to participate and randomly assigned to receive 400 mg Noni capsules or placebo. They were assessed for baseline demographic variables such as age, parity, and BMI. They were also assessed before and after treatment, for pain, menstrual blood loss, and laboratory variables: ESR, hemoglobin, and packed cell volume. Results. Of the 1027 women screened, 100 eligible women were randomized. Of the women completing the study, 42 women were randomized to Noni and 38 to placebo. There were no significant differences in any of the variables at randomization. There were also no significant differences in mean bleeding score or pain score at randomization. Both bleeding and pain scores gradually improved in both groups as the women were observed over three menstrual cycles; however, the improvement was not significantly different in the Noni group when compared to the controls. Conclusion. Noni did not show a reduction in menstrual pain or bleeding when compared to placebo. PMID:23431314

A Prospective, Randomized, Masked, Placebo-Controlled Clinical Study of Capromorelin in Dogs with Reduced Appetite.

PubMed

Zollers, B; Wofford, J A; Heinen, E; Huebner, M; Rhodes, L

2016-11-01

Reduced appetite is a common clinical sign in dogs. This study evaluated the effectiveness and safety of capromorelin oral solution, (ENTYCE ® , Aratana Therapeutics, Leawood, KS) a new drug that is a ghrelin receptor agonist, for stimulation of appetite in dogs with reduced appetite. Capromorelin will increase appetite, as measured by the owner's evaluation, over 4 days. An additional objective was to evaluate the safety of capromorelin at the labeled dose. A total of 244 client-owned dogs reported by owners to be inappetent for at least 2 days were enrolled, with 177 cases in the effectiveness analysis. In this prospective, randomized, masked, placebo-controlled study, dogs were treated daily with capromorelin (3 mg/kg) oral solution (n = 121) or placebo oral solution (n = 56). Owners completed an evaluation of appetite at days 0 and 3 ± 1. Success was defined as improvement in appetite at day 3. Safety was evaluated by physical examination, clinical pathology, and monitoring adverse events and owner observations. Capromorelin treatment improved appetite compared to placebo (68.6% and 44.6% treatment successes with 95% CI 59.7, 76.3 and 32.2, 57.8, respectively, P = .008). Mean body weight in capromorelin-treated dogs increased compared to placebo-treated dogs (1.8% with 95% CI 1.3, 2.3, and 0.1% with 95% CI 0.9, 1.1, respectively, P < .001). Adverse reactions occurring in >5% of either group were diarrhea and vomiting. Capromorelin oral solution is an effective treatment for stimulation of appetite in dogs and represents the first ghrelin receptor agonist shown to be effective for this indication. Copyright © 2016 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

Intravitreal Sirolimus for Noninfectious Uveitis: A Phase III Sirolimus Study Assessing Double-masKed Uveitis TReAtment (SAKURA).

PubMed

Nguyen, Quan Dong; Merrill, Pauline T; Clark, W Lloyd; Banker, Alay S; Fardeau, Christine; Franco, Pablo; LeHoang, Phuc; Ohno, Shigeaki; Rathinam, Sivakumar R; Thurau, Stephan; Abraham, Abu; Wilson, Laura; Yang, Yang; Shams, Naveed

2016-11-01

To evaluate the efficacy and safety of intravitreal sirolimus in the treatment of noninfectious uveitis (NIU) of the posterior segment (i.e., posterior, intermediate, or panuveitis). Phase III, randomized, double-masked, active-controlled, 6-month study with intravitreal sirolimus. Adults with active NIU of the posterior segment (intermediate, posterior, or panuveitis), defined as a vitreous haze (VH) score >1+. Subjects discontinued NIU medications before baseline, except for systemic corticosteroids, which were allowed only for those already receiving them at baseline and were rapidly tapered after baseline per protocol. Intravitreal sirolimus assigned 1:1:1 at doses of 44 (active control), 440, or 880 μg, administered on Days 1, 60, and 120. The primary efficacy outcome was the percentage of subjects with VH 0 response at Month 5 (study eye) without use of rescue therapy. Secondary outcomes at Month 5 were VH 0 or 0.5+ response rate, corticosteroid tapering success rate (i.e., tapering to a prednisone-equivalent dosage of ≤5 mg/day), and changes in best-corrected visual acuity (BCVA). Adverse events during the double-masked treatment period are presented. A total of 347 subjects were randomized. Higher proportions of subjects in the intravitreal sirolimus 440 μg (22.8%; P = 0.025) and 880 μg (16.4%; P = 0.182) groups met the primary end point than in the 44 μg group (10.3%). Likewise, higher proportions of subjects in the 440 μg (52.6%; P = 0.008) and 880 μg (43.1%; P = 0.228) groups achieved a VH score of 0 or 0.5+ than in the 44 μg group (35.0%). Mean BCVA was maintained throughout the study in each dose group, and the majority of subjects receiving corticosteroids at baseline successfully tapered off corticosteroids (44 μg [63.6%], 440 μg [76.9%], and 880 μg [66.7%]). Adverse events in the treatment and active control groups were similar in incidence, and all doses were well tolerated. Intravitreal sirolimus 440 μg demonstrated a significant improvement in ocular inflammation with preservation of BCVA in subjects with active NIU of the posterior segment. Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

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

Acute tryptophan depletion attenuates conscious appraisal of social emotional signals in healthy female volunteers.

PubMed

Beacher, Felix D C C; Gray, Marcus A; Minati, Ludovico; Whale, Richard; Harrison, Neil A; Critchley, Hugo D

2011-02-01

Acute tryptophan depletion (ATD) decreases levels of central serotonin. ATD thus enables the cognitive effects of serotonin to be studied, with implications for the understanding of psychiatric conditions, including depression. To determine the role of serotonin in conscious (explicit) and unconscious/incidental processing of emotional information. A randomized, double-blind, cross-over design was used with 15 healthy female participants. Subjective mood was recorded at baseline and after 4 h, when participants performed an explicit emotional face processing task, and a task eliciting unconscious processing of emotionally aversive and neutral images presented subliminally using backward masking. ATD was associated with a robust reduction in plasma tryptophan at 4 h but had no effect on mood or autonomic physiology. ATD was associated with significantly lower attractiveness ratings for happy faces and attenuation of intensity/arousal ratings of angry faces. ATD also reduced overall reaction times on the unconscious perception task, but there was no interaction with emotional content of masked stimuli. ATD did not affect breakthrough perception (accuracy in identification) of masked images. ATD attenuates the attractiveness of positive faces and the negative intensity of threatening faces, suggesting that serotonin contributes specifically to the appraisal of the social salience of both positive and negative salient social emotional cues. We found no evidence that serotonin affects unconscious processing of negative emotional stimuli. These novel findings implicate serotonin in conscious aspects of active social and behavioural engagement and extend knowledge regarding the effects of ATD on emotional perception.

The lithographer's dilemma: shrinking without breaking the bank

NASA Astrophysics Data System (ADS)

Levinson, Harry J.

2013-10-01

It can no longer be assumed that the lithographic scaling which has previously driven Moore's Law will lead in the future to reduced cost per transistor. Until recently, higher prices for lithography tools were offset by improvements in scanner productivity. The necessity of using double patterning to extend scaling beyond the single exposure resolution limit of optical lithography has resulted in a sharp increase in the cost of patterning a critical construction layer that has not been offset by improvements in exposure tool productivity. Double patterning has also substantially increased the cost of mask sets. EUV lithography represents a single patterning option, but the combination of very high exposure tools prices, moderate throughput, high maintenance costs, and expensive mask blanks makes this a solution more expensive than optical double patterning but less expensive than triple patterning. Directed self-assembly (DSA) could potentially improve wafer costs, but this technology currently is immature. There are also design layout and process integration issues associated with DSA that need to be solved in order to obtain full benefit from tighter pitches. There are many approaches for improving the cost effectiveness of lithography. Innovative double patterning schemes lead to smaller die. EUV lithography productivity can be improved with higher power light sources and improved reliability. There are many technical and business challenges for extending EUV lithography to higher numerical apertures. Efficient contact hole and cut mask solutions are needed, as well as very tight overlay control, regardless of lithographic solution.

Efficacy and safety of pimecrolimus cream 1% in mild-to-moderate chronic hand dermatitis: a randomized, double-blind trial.

PubMed

Hordinsky, Maria; Fleischer, Alan; Rivers, Jason K; Poulin, Yves; Belsito, Donald; Hultsch, Thomas

2010-08-01

Chronic hand dermatitis is common and difficult to treat. Our aim was to assess the efficacy of pimecrolimus cream 1% in mild-to-moderate chronic hand dermatitis. Adult patients (n = 652) were randomized to pimecrolimus 1% or vehicle cream twice daily with overnight occlusion for 6 weeks, followed by a 6-week open-label pimecrolimus treatment. Primary efficacy was 5-point Investigators' Global Assessment of prospectively selected 'target hand' as treatment success (Investigators' Global Assessment 0 or 1) and treatment failure. Pruritus relief was also assessed. Following double-blind phase treatment, target hand treatment success was achieved in 29.8 and 23.2% of the patients in the pimecrolimus and vehicle groups, respectively (p = 0.057). The proportion of patients experiencing pruritus relief was significantly higher in the pimecrolimus group compared to the vehicle group at all time points throughout the double-blind phase. The groups were comparable with respect to treating disease signs. Pruritus relief, however, was significantly greater in the pimecrolimus group. Copyright 2010 S. Karger AG, Basel.

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.

Influence of orthopedic reinforced gloves versus double standard gloves on contamination events during small animal orthopedic surgery.

PubMed

Hayes, Galina; Singh, Ameet; Gibson, Tom; Moens, Noel; Oblak, Michelle; Ogilvie, Adam; Reynolds, Debbie

2017-10-01

To determine the influence of orthopedic reinforced gloves on contamination events during small animal orthopedic surgery. Prospective randomized controlled trial SAMPLE POPULATION: Two hundred and thirty-seven pairs of orthopedic gloves (474 gloves) and 203 pairs of double standard gloves (812 gloves) worn during 193 orthopedic procedures. Primary and assistant surgeons were randomized to wear either orthopedic reinforced gloves or double gloves. Gloves were leak tested to identify perforations at the end of procedures. Perforations detected intraoperatively or postoperatively were recorded. A contamination event was defined as at least one perforation on either hand for orthopedic reinforced gloves, or a perforation of both the inner and outer glove on the same hand for double gloves. Baseline characteristics between the 2 intervention groups were similar. There was no difference in contamination events between the double-gloved and orthopedic gloved groups (OR = 0.95, 95% CI = 0.49-1.87, P = .89). The same percentage of contamination events (8% glove pairs used) occurred in the double gloved group (17 contamination events) and in the orthopedic gloved group (19 contamination events). The odds of a contamination event increased by 1.02 (95% CI 1.01-1.03, P < .001) with each additional minute of surgery. Orthopedic reinforced gloves and double standard gloving were equally effective at preventing contamination events in small animal orthopedic procedures. Surgeons reluctant to double glove due to perceptions of decreased dexterity and discomfort may safely opt for wearing orthopedic gloves, which may improve their compliance. © 2017 The American College of Veterinary Surgeons.

Rates of initial acceptance of PAP masks and outcomes of mask switching.

PubMed

Bachour, Adel; Vitikainen, Pirjo; Maasilta, Paula

2016-05-01

Recently, we noticed a considerable development in alleviating problems related to positive airway pressure (PAP) masks. In this study, we report on the initial PAP mask acceptance rates and the effects of mask switching on mask-related symptoms. We prospectively collected all cases of mask switching in our sleep unit for a period of 14 months. At the time of the study, we used ResMed™ CPAP devices and masks. Mask switching was defined as replacing a mask used for at least 1 day with another type of mask. Changing to a different size but keeping the same type of mask did not count as mask switching. Switching outcomes were considered failed if the initial problem persisted or reappeared during the year that followed switching. Our patient pool was 2768. We recorded 343 cases of mask switching among 267 patients. Of the 566 patients who began new PAP therapy, 108 (39 women) had switched masks, yielding an initial mask acceptance rate of 81 %. The reason for switching was poor-fit/uncomfortable mask in 39 %, leak-related in 30 %, outdated model in 25 %, and nasal stuffiness in 6 % of cases; mask switching resolved these problems in 61 %. Mask switching occurred significantly (p = 0.037) more often in women and in new PAP users. The odds ratio for abandoning PAP therapy within 1 year after mask switching was 7.2 times higher (interval 4.7-11.1) than not switching masks. The initial PAP mask acceptance rate was high. Patients who switched their masks are at greater risk for abandoning PAP therapy.

A Herbal Medicine, Gongjindan, in Subjects with Chronic Dizziness (GOODNESS Study): Study Protocol for a Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial for Effectiveness, Safety, and Cost-Effectiveness

PubMed Central

Kim, Jinyoung; Cho, Jae-Heung

2017-01-01

This study protocol aims to explore the effectiveness, safety, and cost-effectiveness of a herbal medication, Gongjindan (GJD), in patients with chronic dizziness. This will be a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, clinical trial. Seventy-eight patients diagnosed with Meniere's disease, psychogenic dizziness, or dizziness of unknown cause will be randomized and allocated to either a GJD or a placebo group in a 1 : 1 ratio. Participants will be orally given 3.75 g GJD or placebo in pill form once a day for 56 days. The primary outcome measure will be the Dizziness Handicap Inventory score. Secondary outcome measures will be as follows: severity (mean vertigo scale and visual analogue scale) and frequency of dizziness, balance function (Berg Balance Scale), fatigue (Fatigue Severity Scale) and deficiency pattern/syndrome (qi blood yin yang-deficiency questionnaire) levels, and depression (Korean version of Beck's Depression Inventory) and anxiety (State-Trait Anxiety Inventory) levels. To assess safety, adverse events, including laboratory test results, will be monitored. Further, the incremental cost-effectiveness ratio will be calculated based on quality-adjusted life years (from the EuroQoL five dimensions' questionnaire) and medical expenses. Data will be statistically analyzed at a significance level of 0.05 (two-sided). This trial is registered with ClinicalTrials.gov NCT03219515, in July 2017. PMID:29387128

Evaluation of the impact of preoperative education in ambulatory laparoscopic cholecystectomy. A prospective, double-blind randomized trial.

PubMed

Subirana Magdaleno, Helena; Caro Tarragó, Aleidis; Olona Casas, Carles; Díaz Padillo, Alba; Franco Chacón, Mario; Vadillo Bargalló, Jordi; Saludes Serra, Judit; Jorba Martín, Rosa

2018-02-01

Outpatient laparoscopic cholecystectomy is a safe procedure and provides a better use of health resources and perceived satisfaction without affecting quality of care. Preoperative education has shown less postoperative stress, pain and nausea in some interventions. The principal objective of this study is to assess the impact of preoperative education on postoperative pain in patients undergoing ambulatory laparoscopic cholecystectomy. Secondary objectives were: to evaluate presence of nausea, morbidity, hospital admissions, readmissions rate, quality of life and satisfaction. Prospective, randomized, and double blind study. Between April 2014 and May 2016, 62 patients underwent outpatient laparoscopic cholecystectomy. ASA I-II, age 18-75, outpatient surgery criteria, abdominal ultrasonography with cholelithiasis. Patient randomization in two groups, group A: intensified preoperative education and group B: control. Sixty-two patients included, 44 women (71%), 18 men (29%), mean age 46,8 years (20-69). Mean BMI 27,5. Outpatient rate 92%. Five cases required admission, two due to nausea. Pain scores obtained using a VAS was at 24-hour, 2,9 in group A and 2,7 in group B. There were no severe complications or readmissions. Results of satisfaction and quality of life scores were similar for both groups. We did not find differences due to intensive preoperative education. However, we think that a correct information protocol should be integrated into the patient's preoperative preparation. Registered in ISRCTN number ISRCTN83787412. Copyright © 2017 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

Topical Botulinum Toxin Type A Liposomal Cream for Primary Axillary Hyperhidrosis: A Double-Blind, Randomized, Split-Site, Vehicle-Controlled Study.

PubMed

Lueangarun, Suparuj; Sermsilp, Chairat; Tempark, Therdpong

2018-04-13

Despite its effectiveness in treating primary axillary hyperhidrosis (PAH), topical botulinum toxin type A (BTX-A) is highly resistant to transdermal absorption. Topical BTX-A liposomal cream is recommended as a novel, noninvasive modality to enhance skin penetration. To evaluate the efficacy and safety of topical BTX-A liposomal cream in comparison with liposomal vehicle cream alone in the treatment of PAH. A prospective, randomized, double-blinded, split-site study was conducted in 20 subjects, aged 18 to 50 years, all of whom had symmetrical axillary sweating with Hyperhidrosis Disease Severity Scale scores between 2 to 4. All subjects were double-blinded to treatment regimens and randomly given 2 bottles, one containing topical BTX-A liposomal cream and one containing the vehicle cream without BTX-A, to be applied consistently to the same axilla nightly for 7 consecutive days. Clinical improvement and adverse reactions were evaluated at every follow-up visit. Axillary skin treated with topical BTX-A demonstrated superior sweat reduction and patient satisfaction to vehicle cream-treated axillary skin, with clinical and statistical significance, at baseline, weeks 2, 4, 6, and 8 of follow-up, without adverse effects. Topical BTX-A liposomal cream pharmaceutically enhances drug delivery, is painless, cost-effective, and overall an innovative treatment of PAH.

Clinical review: Helmet and non-invasive mechanical ventilation in critically ill patients.

PubMed

Esquinas Rodriguez, Antonio M; Papadakos, Peter J; Carron, Michele; Cosentini, Roberto; Chiumello, Davide

2013-04-25

Non-invasive mechanical ventilation (NIV) has proved to be an excellent technique in selected critically ill patients with different forms of acute respiratory failure. However, NIV can fail on account of the severity of the disease and technical problems, particularly at the interface. The helmet could be an alternative interface compared to face mask to improve NIV success. We performed a clinical review to investigate the main physiological and clinical studies assessing the efficacy and related issues of NIV delivered with a helmet. A computerized search strategy of MEDLINE/PubMed (January 2000 to May 2012) and EMBASE (January 2000 to May 2012) was conducted limiting the search to retrospective, prospective, nonrandomized and randomized trials. We analyzed 152 studies from which 33 were selected, 12 physiological and 21 clinical (879 patients). The physiological studies showed that NIV with helmet could predispose to CO₂ rebreathing and increase the patients' ventilator asynchrony. The main indications for NIV were acute cardiogenic pulmonary edema, hypoxemic acute respiratory failure (community-acquired pneumonia, postoperative and immunocompromised patients) and hypercapnic acute respiratory failure. In 9 of the 21 studies the helmet was compared to a face mask during either continous positive airway pressure or pressure support ventilation. In eight studies oxygenation was similar in the two groups, while the intubation rate was similar in four and lower in three studies for the helmet group compared to face mask group. The outcome was similar in six studies. The tolerance was better with the helmet in six of the studies. Although these data are limited, NIV delivered by helmet could be a safe alternative to the face mask in patients with acute respiratory failure.

Efficacy of prophylactic droperidol, ondansetron or both in the prevention of postoperative nausea and vomiting in major gynaecological surgery. A prospective, randomized, double-blind clinical trial.

PubMed

Peixoto, A J; Peixoto Filho, A J; Leães, L F; Celich, M F; Barros, M A

2000-10-01

We conducted a prospective, randomized, double-blind clinical trial comparing droperidol 1.25 mg intravenously (i.v.) (group 1, n = 30), ondansetron 4 mg i.v. (group 2, n = 30), or both (group 3, n = 30) in the prevention of postoperative nausea and vomiting (PONV) in the first 24 h following major gynaecological procedures under combined general and epidural anaesthesia. PONV was analysed by a linear nausea/vomiting score, incidence of nausea and vomiting, and the need for antiemetic rescue. Our results showed a similar incidence of nausea and vomiting in all groups (G1 33%, G2 40%, G3 43%). However, when comparisons were made according to the time of assessment, combination therapy resulted in significantly lower PONV than droperidol in the first hour (0% vs. 13%, P < 0.05) and second hour (0% vs. 13%, P < 0.05), and than ondansetron on the first hour (0% vs. 13%, P < 0.05). A trend persisted up to the fourth hour but was not statistically significant in either group. In conclusion, droperidol and ondansetron are effective agents in the prevention of PONV, and their combination seems to provide slightly better results than either drug alone.

A prospective, randomized, double-blinded single-site control study comparing blood loss prevention of tranexamic acid (TXA) to epsilon aminocaproic acid (EACA) for corrective spinal surgery.

PubMed

Verma, Kushagra; Errico, Thomas J; Vaz, Kenneth M; Lonner, Baron S

2010-04-06

Multilevel spinal fusion surgery has typically been associated with significant blood loss. To limit both the need for transfusions and co-morbidities associated with blood loss, the use of anti-fibrinolytic agents has been proposed. While there is some literature comparing the effectiveness of tranexamic acid (TXA) to epsilon aminocaproic acid (EACA) in cardiac procedures, there is currently no literature directly comparing TXA to EACA in orthopedic surgery. Here we propose a prospective, randomized, double-blinded control study evaluating the effects of TXA, EACA, and placebo for treatment of adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis (NMS), and adult deformity (AD) via corrective spinal surgery. Efficacy will be determined by intraoperative and postoperative blood loss. Other clinical outcomes that will be compared include transfusion rates, preoperative and postoperative hemodynamic values, and length of hospital stay after the procedure. The primary goal of the study is to determine perioperative blood loss as a measure of the efficacy of TXA, EACA, and placebo. Based on current literature and the mechanism by which the medications act, we hypothesize that TXA will be more effective at reducing blood loss than EACA or placebo and result in improved patient outcomes. ClinicalTrials.gov ID: NCT00958581.

Comparing the effects of single shot sciatic nerve block versus posterior capsule local anesthetic infiltration on analgesia and functional outcome after total knee arthroplasty: a prospective, randomized, double-blinded, controlled trial.

PubMed

Safa, Ben; Gollish, Jeffrey; Haslam, Lynn; McCartney, Colin J L

2014-06-01

Peripheral nerve blocks appear to provide effective analgesia for patients undergoing total knee arthroplasty. Although the literature supports the use of femoral nerve block, addition of sciatic nerve block is controversial. In this study we investigated the value of sciatic nerve block and an alternative technique of posterior capsule local anesthetic infiltration analgesia. 100 patients were prospectively randomized into three groups. Group 1: sciatic nerve block; Group 2: posterior local anesthetic infiltration; Group 3: control. All patients received a femoral nerve block and spinal anesthesia. There were no differences in pain scores between groups. Sciatic nerve block provided a brief clinically insignificant opioid sparing effect. We conclude that sciatic nerve block and posterior local anesthetic infiltration do not provide significant analgesic benefits. Copyright © 2014 Elsevier Inc. All rights reserved.

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

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.

X ray reflection masks: Manufacturing, characterization and first tests

NASA Astrophysics Data System (ADS)

Rahn, Stephen

1992-09-01

SXPL (Soft X-ray Projection Lithography) multilayer mirrors are characterized, laterally structured and then used as reflection masks in a projecting lithography procedure. Mo/Si-multilayer mirrors with a 2d in the region of 14 nm were characterized by Cu-k(alpha) grazing incidence as well as soft X-ray normal incidence reflectivity measurements. The multilayer mirrors were patterned by reactive ion etching with CF4 using a photoresist as etch mask, thus producing X-ray reflection masks. The masks were tested at the synchrotron radiation laboratory of the electron accelerator ELSA. A double crystal X-ray monochromator was modified so as to allow about 0.5 sq cm of the reflection mask to be illuminated by white synchrotron radiation. The reflected patterns were projected (with an energy of 100 eV) onto a resist and structure sizes down to 8 micrometers were nicely reproduced. Smaller structures were distorted by Fresnel-diffraction. The theoretically calculated diffraction images agree very well with the observed images.

Clinical evidence for individual animal therapy for papillomatous digital dermatitis (hairy heel wart) and infectious bovine pododermatitis (foot rot).

PubMed

Apley, Michael D

2015-03-01

Data supporting individual animal therapy for papillomatous digital dermatitis (PDD) and infectious pododermatitis (IP) in cattle are available for treatment with multiple drugs in the form of randomized, prospective clinical trials conducted in naturally occurring disease with negative controls and masked subjective evaluators. In the case of PDD, these trials support the use of topical tetracycline and oxytetracycline, lincomycin, a copper-containing preparation, and a nonantimicrobial cream. In individual therapy for IP, trial evidence is available to support systemic treatment with ceftiofur, florfenicol, tulathromycin, and oxytetracycline. However, it was not available for IP standards such as penicillin G, sulfadimethoxine, and tylosin. Copyright © 2015 Elsevier Inc. All rights reserved.

Efficacy and safety of sacubitril/valsartan (LCZ696) in Japanese patients with chronic heart failure and reduced ejection fraction: Rationale for and design of the randomized, double-blind PARALLEL-HF study.

PubMed

Tsutsui, Hiroyuki; Momomura, Shinichi; Saito, Yoshihiko; Ito, Hiroshi; Yamamoto, Kazuhiro; Ohishi, Tomomi; Okino, Naoko; Guo, Weinong

2017-09-01

The prognosis of heart failure patients with reduced ejection fraction (HFrEF) in Japan remains poor, although there is growing evidence for increasing use of evidence-based pharmacotherapies in Japanese real-world HF registries. Sacubitril/valsartan (LCZ696) is a first-in-class angiotensin receptor neprilysin inhibitor shown to reduce mortality and morbidity in the recently completed largest outcome trial in patients with HFrEF (PARADIGM-HF trial). The prospectively designed phase III PARALLEL-HF (Prospective comparison of ARNI with ACE inhibitor to determine the noveL beneficiaL trEatment vaLue in Japanese Heart Failure patients) study aims to assess the clinical efficacy and safety of LCZ696 in Japanese HFrEF patients, and show similar improvements in clinical outcomes as the PARADIGM-HF study enabling the registration of LCZ696 in Japan. This is a multicenter, randomized, double-blind, parallel-group, active controlled study of 220 Japanese HFrEF patients. Eligibility criteria include a diagnosis of chronic HF (New York Heart Association Class II-IV) and reduced ejection fraction (left ventricular ejection fraction ≤35%) and increased plasma concentrations of natriuretic peptides [N-terminal pro B-type natriuretic peptide (NT-proBNP) ≥600pg/mL, or NT-proBNP ≥400pg/mL for those who had a hospitalization for HF within the last 12 months] at the screening visit. The study consists of three phases: (i) screening, (ii) single-blind active LCZ696 run-in, and (iii) double-blind randomized treatment. Patients tolerating LCZ696 50mg bid during the treatment run-in are randomized (1:1) to receive LCZ696 100mg bid or enalapril 5mg bid for 4 weeks followed by up-titration to target doses of LCZ696 200mg bid or enalapril 10mg bid in a double-blind manner. The primary outcome is the composite of cardiovascular death or HF hospitalization and the study is an event-driven trial. The design of the PARALLEL-HF study is aligned with the PARADIGM-HF study and aims to assess the efficacy and safety of LCZ696 in Japanese HFrEF patients. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

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.

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.

Different effectiveness of closed embryo culture system with time-lapse imaging (EmbryoScope(TM)) in comparison to standard manual embryology in good and poor prognosis patients: a prospectively randomized pilot study.

PubMed

Wu, Yan-Guang; Lazzaroni-Tealdi, Emanuela; Wang, Qi; Zhang, Lin; Barad, David H; Kushnir, Vitaly A; Darmon, Sarah K; Albertini, David F; Gleicher, Norbert

2016-08-24

Previously manual human embryology in many in vitro fertilization (IVF) centers is rapidly being replaced by closed embryo incubation systems with time-lapse imaging. Whether such systems perform comparably to manual embryology in different IVF patient populations has, however, never before been investigated. We, therefore, prospectively compared embryo quality following closed system culture with time-lapse photography (EmbryoScope™) and standard embryology. We performed a two-part prospectively randomized study in IVF (clinical trial # NCT92256309). Part A involved 31 infertile poor prognosis patients prospectively randomized to EmbryoScope™ and standard embryology. Part B involved embryos from 17 egg donor-recipient cycles resulting in large egg/embryo numbers, thus permitting prospectively alternative embryo assignments to EmbryoScope™ and standard embryology. We then compared pregnancy rates and embryo quality on day-3 after fertilization and embryologist time utilized per processed embryo. Part A revealed in poor prognosis patients no differences in day-3 embryo scores, implantation and clinical pregnancy rates between EmbryoScope™ and standard embryology. The EmbryoScope™, however, more than doubled embryology staff time (P < 0.0001). In Part B, embryos grown in the EmbyoScope™ demonstrated significantly poorer day-3 quality (depending on embryo parameter between P = 0.005 and P = 0.01). Suspicion that conical culture dishes of the EmbryoScope™ (EmbryoSlide™) may be the cause was disproven when standard culture dishes demonstrated no outcome difference in standard incubation. Though due to small patient numbers preliminary, this study raises concerns about the mostly uncontrolled introduction of closed incubation systems with time lapse imaging into routine clinical embryology. Appropriately designed and powered prospectively randomized studies appear urgently needed in well-defined patient populations before the uncontrolled utilization of these instruments further expands. NCT02246309 Registered September 18, 2014.

Rebamipide (OPC-12759) in the treatment of dry eye: a randomized, double-masked, multicenter, placebo-controlled phase II study.

PubMed

Kinoshita, Shigeru; Awamura, Saki; Oshiden, Kazuhide; Nakamichi, Norihiro; Suzuki, Hiroyuki; Yokoi, Norihiko

2012-12-01

To investigate the dose response for efficacy of 1% and 2% rebamipide ophthalmic suspension compared with placebo in patients with dry eye. A randomized, double-masked, multicenter, placebo-controlled, parallel-group, dose-response phase II study. A total of 308 patients with dry eye. After a 2-week screening period, patients were randomized to receive placebo or 1% rebamipide or 2% rebamipide administered as 1 drop in each eye 4 times daily for 4 weeks. The primary objective end point was change in fluorescein corneal staining (FCS) score from baseline to last observation carried forward (LOCF). Secondary objective end points were lissamine green conjunctival staining (LGCS) score, tear film break-up time (TBUT), and the Schirmer's test. Secondary subjective end points included dry eye-related ocular symptoms (foreign body sensation, dryness, photophobia, eye pain, and blurred vision) score and patients' overall treatment impression score. Rebamipide dose response was observed in FCS, LGCS, and TBUT scores. Both 1% and 2% rebamipide were significantly more effective than the placebo in terms of the change from baseline to LOCF for FCS, LGCS, and TBUT scores. There was no significant difference between the rebamipide and placebo groups from baseline to LOCF in Schirmer's test values, and dose response was not observed. In the predefined dry eye subpopulation with a baseline FCS score of 10 to 15, the mean change from baseline in the 2% rebamipide group was larger than that in the 1% rebamipide group. Change from baseline to LOCF for all 5 dry eye-related ocular symptom scores and patients' overall treatment impression showed significant improvements in the 1% and 2% rebamipide groups compared with the placebo group, except for photophobia in the 1% rebamipide group. No deaths or drug-related serious adverse events occurred in any treatment group. The incidence of ocular abnormalities was similar across the rebamipide and placebo groups. Rebamipide was effective in treating both objective signs and subjective symptoms of dry eye and were well tolerated in this 4-week study. Although 1% and 2% rebamipide were both efficacious, 2% rebamipide may be more effective than 1% rebamipide in some measures. Proprietary or commercial disclosure may be found after the references. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Micronutrient Fortified Milk Improves Iron Status, Anemia and Growth among Children 1–4 Years: A Double Masked, Randomized, Controlled Trial

PubMed Central

Sazawal, Sunil; Dhingra, Usha; Dhingra, Pratibha; Hiremath, Girish; Sarkar, Archana; Dutta, Arup; Menon, Venugopal P.; Black, Robert E.

2010-01-01

Background Multiple micronutrient deficiencies are highly prevalent among preschool children and often lead to anemia and growth faltering. Given the limited success of supplementation and health education programs, fortification of foods could be a viable and sustainable option. We report results from a community based double-masked, randomized trial among children 1–4 years evaluating the effects of micronutrients (especially of zinc and iron) delivered through fortified milk on growth, anemia and iron status markers as part of a four group study design, running two studies simultaneously. Methods and Findings Enrolled children (n = 633) were randomly allocated to receive either micronutrients fortified milk (MN = 316) or control milk (Co = 317). Intervention of MN milk provided additional 7.8 mg zinc, 9.6 mg iron, 4.2 µg selenium, 0.27 mg copper, 156 µg vitamin A, 40.2 mg vitamin C, and 7.5 mg vitamin E per day (three serves) for one year. Anthropometry was recorded at baseline, mid- and end-study. Hematological parameters were estimated at baseline and end-study. Both groups were comparable at baseline. Compliance was over 85% and did not vary between groups. Compared to children consuming Co milk, children consuming MN milk showed significant improvement in weight gain (difference of mean: 0.21 kg/year; 95% confidence interval [CI] 0.12 to 0.31, p<0.001) and height gain (difference of mean: 0.51 cm/year; 95% CI 0.27 to 0.75, p<0.001). Mean hemoglobin (Hb) (difference of 13.6 g/L; 95% CI 11.1 to 16.0, p<0.001) and serum ferritin levels (difference of 7.9 µg/L; 95% CI 5.4 to 10.5, p<0.001) also improved. Children in MN group had 88% (odds ratio = 0.12, 95% CI 0.08 to 0.20, p<0.001) lower risk of iron deficiency anemia. Conclusions/Significance Milk provides an acceptable and effective vehicle for delivery of specific micronutrients, especially zinc and iron. Micronutrient bundle improved growth and iron status and reduced anemia in children 1–4 years old. Trial Registration ClinicalTrials.gov NCT00255385 PMID:20730057

The long-term efficacy of hydrocele treatment with aspiration and sclerotherapy with polidocanol compared to placebo: a prospective, double-blind, randomized study.

PubMed

Lund, L; Kloster, A; Cao, T

2014-05-01

We evaluate whether aspiration and sclerosing of hydrocele testis is an effective treatment. Men with symptomatic hydrocele testis were included in this prospective, double-blind, randomized study with polidocanol and placebo. Patients were randomized to active treatment or placebo at the first treatment. Depending on hydrocele testis size (less than 100, 100 to 200 and greater than 200 ml), the patients were treated with 1, 3 or 4 ml polidocanol after aspiration. Patients with recurrence at the 5-week followup received active treatment. A total of 77 patients were included in the study. In group 1 (active treatment) there were 36 patients with a median age of 63 years (range 34 to 92). In group 2, comprised of 41 patients, the median age was 59 years (range 26 to 82). Median followup was 72 months. A significant difference between the groups was observed after the first and second treatments. Recurrence after the first treatment was seen in 16 (44%) patients from group 1 and in 32 (78%) from group 2 (p <0.05). Recurrence after re-treatment with the active drug in both groups was seen in 4 (25%) patients in group 1 and in 14 (44%) in the former placebo group (p <0.05). The overall success rate of treatment in the active group was 89%. There was no difference between the 2 groups in terms of volume of fluid aspirated, symptoms or complications. This long-term efficacy randomized study with placebo showed that polidocanol is effective for the treatment of hydrocele testis with a low recurrence rate. Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Treatment of chronic antibody mediated rejection with intravenous immunoglobulins and rituximab: A multicenter, prospective, randomized, double-blind clinical trial.

PubMed

Moreso, Francesc; Crespo, Marta; Ruiz, Juan C; Torres, Armando; Gutierrez-Dalmau, Alex; Osuna, Antonio; Perelló, Manel; Pascual, Julio; Torres, Irina B; Redondo-Pachón, Dolores; Rodrigo, Emilio; Lopez-Hoyos, Marcos; Seron, Daniel

2018-04-01

There are no approved treatments for chronic antibody mediated rejection (ABMR). We conducted a multicenter, prospective, randomized, placebo-controlled, double-blind clinical trial to evaluate efficacy and safety of intravenous immunoglobulins (IVIG) combined with rituximab (RTX) (EudraCT 2010-023746-67). Patients with transplant glomerulopathy and anti-HLA donor-specific antibodies (DSA) were eligible. Patients with estimated glomerular filtration rate (eGFR) <20 mL/min per 1.73m 2 and/or severe interstitial fibrosis/tubular atrophy were excluded. Patients were randomized to receive IVIG (4 doses of 0.5 g/kg) and RTX (375 mg/m 2 ) or a wrapped isovolumetric saline infusion. Primary efficacy variable was the decline of eGFR at one year. Secondary efficacy variables included evolution of proteinuria, renal lesions, and DSA at 1 year. The planned sample size was 25 patients per group. During 2012-2015, 25 patients were randomized (13 to the treatment and 12 to the placebo group). The planned patient enrollment was not achieved because of budgetary constraints and slow patient recruitment. There were no differences between the treatment and placebo groups in eGFR decline (-4.2 ± 14.4 vs. -6.6 ± 12.0 mL/min per 1.73 m 2 , P-value = .475), increase of proteinuria (+0.9 ± 2.1 vs. +0.9 ± 2.1 g/day, P-value = .378), Banff scores at one year and MFI of the immunodominant DSA. Safety was similar between groups. These data suggest that the combination of IVIG and RTX is not useful in patients displaying transplant glomerulopathy and DSA. © 2017 The American Society of Transplantation and the American Society of Transplant Surgeons.

Hormone replacement therapy in women with epilepsy: a randomized, double-blind, placebo-controlled study.

PubMed

Harden, Cynthia L; Herzog, Andrew G; Nikolov, Blagovest G; Koppel, Barbara S; Christos, Paul J; Fowler, Kristen; Labar, Douglas R; Hauser, W Allen

2006-09-01

Previous reports have suggested that hormone replacement therapy (HRT) could increase seizure activity in women with epilepsy. We sought to determine whether adding HRT to the medication regimen of postmenopausal women with epilepsy was associated with an increase in seizure frequency. This was a randomized, double-blind, placebo-controlled trial of the effect of HRT on seizure frequency in postmenopausal women with epilepsy, taking stable doses of antiepileptic drugs (AEDs), and within 10 years of their last menses. After a 3-month prospective baseline, subjects were randomized to placebo, Prempro (0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone acetate or CEE/MPA) daily, or double-dose CEE/MPA daily for a 3-month treatment period. Twenty-one subjects were randomized after completing baseline. The subjects' ages ranged from 45 to 62 years (mean, 53 years; SD, +/-5), and the number of AEDs used ranged from none to three (median, one). Five (71%) of seven subjects taking double-dose CEE/MPA had a worsening seizure frequency of at least one seizure type, compared with four (50%) of eight taking single-dose CEE/MPA and one (17%) of six taking placebo (p = 0.05). An increase in seizure frequency of the subject's most severe seizure type was associated with increasing CEE/MPA dose (p = 0.008). An increase in complex partial seizure frequency also was associated with increasing CEE/MPA dose (p = 0.05). Two subjects taking lamotrigine had a decrease in lamotrigine levels of 25-30% while taking CEE/MPA. CEE/MPA is associated with a dose-related increase in seizure frequency in postmenopausal women with epilepsy. CEE/MPA may decrease lamotrigine levels.

Exploring the Effect of Lactium™ and Zizyphus Complex on Sleep Quality: A Double-Blind, Randomized Placebo-Controlled Trial

PubMed Central

Scholey, Andrew; Benson, Sarah; Gibbs, Amy; Perry, Naomi; Sarris, Jerome; Murray, Greg

2017-01-01

Acute, non-clinical insomnia is not uncommon. Sufferers commonly turn to short-term use of herbal supplements to alleviate the symptoms. This placebo-controlled, double-blind study investigated the efficacy of LZComplex3 (lactium™, Zizyphus, Humulus lupulus, magnesium and vitamin B6), in otherwise healthy adults with mild insomnia. After a 7-day single-blind placebo run-in, eligible volunteers (n = 171) were randomized (1:1) to receive daily treatment for 2 weeks with LZComplex3 or placebo. Results revealed that sleep quality measured by change in Pittsburgh Sleep Quality Index (PSQI) score improved in both the LZComplex3 and placebo groups. There were no significant between group differences between baseline and endpoint on the primary outcome. The majority of secondary outcomes, which included daytime functioning and physical fatigue, mood and anxiety, cognitive performance, and stress reactivity, showed similar improvements in the LZComplex3 and placebo groups. A similar proportion of participants reported adverse events (AEs) in both groups, with two of four treatment-related AEs in the LZComplex3 group resulting in permanent discontinuation. It currently cannot be concluded that administration of LZComplex3 for 2 weeks improves sleep quality, however, a marked placebo response (despite placebo run-in) and/or short duration of treatment may have masked a potential beneficial effect on sleep quality. PMID:28218661

Probing particle and nuclear physics models of neutrinoless double beta decay with different nuclei

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

Fogli, G. L.; Rotunno, A. M.; Istituto Nazionale di Fisica Nucleare, Sezione di Bari, Via Orabona 4, 70126 Bari

2009-07-01

Half-life estimates for neutrinoless double beta decay depend on particle physics models for lepton-flavor violation, as well as on nuclear physics models for the structure and transitions of candidate nuclei. Different models considered in the literature can be contrasted - via prospective data - with a 'standard' scenario characterized by light Majorana neutrino exchange and by the quasiparticle random phase approximation, for which the theoretical covariance matrix has been recently estimated. We show that, assuming future half-life data in four promising nuclei ({sup 76}Ge, {sup 82}Se, {sup 130}Te, and {sup 136}Xe), the standard scenario can be distinguished from a fewmore » nonstandard physics models, while being compatible with alternative state-of-the-art nuclear calculations (at 95% C.L.). Future signals in different nuclei may thus help to discriminate at least some decay mechanisms, without being spoiled by current nuclear uncertainties. Prospects for possible improvements are also discussed.« less

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.

Insertion of the endotracheal tube, laryngeal mask airway and oesophageal-tracheal Combitube. A 6-month comparative prospective study of acquisition and retention skills by medical students.

PubMed

Weksler, N; Tarnopolski, A; Klein, M; Schily, M; Rozentsveig, V; Shapira, A R; Gurman, G M

2005-05-01

To assess the ability of medical students to learn and retain skills of airway manipulation for insertion of the endotracheal tube, the laryngeal mask airway (Laryngeal Mask Company, Henley-on-Thames, UK) and the oesophageal-tracheal Combitube (Kendall-Sheridan Catheter Corp., Argyle, NY, USA). A 6-month prospective study was conducted among fifth-year medical students attending a 3-week clerkship in the Division of Anesthesiology and Critical Care Medicine in the Soroka Medical Center. All the students viewed a demonstration of insertion technique for the endotracheal tube, the laryngeal mask airway and the Combitube, followed by formal teaching in a mannikin. At the end of the program, the insertion skills were demonstrated in the mannikin, the success rate on the first attempt was registered and the students were requested to assess (by questionnaire) their ability to execute airway manipulation (phase 1). Six months later, the students were requested to repeat the insertion technique, and a similar re-evaluation applied (phase 2). The success rate, during the first phase, at first attempts was 100% for the laryngeal mask airway and the Combitube, compared to 57.4% for the endotracheal tube (P < 0.02), and 92.6%, 96.2% and 62.9% (P < 0.02) respectively for the second phase of the study. Learning and retention skills of medical students, in a mannikin, are more accentuated with the laryngeal mask airway and the Combitube than seen with an endotracheal tube.

Nasal mask ventilation is better than face mask ventilation in edentulous patients.

PubMed

Kapoor, Mukul Chandra; Rana, Sandeep; Singh, Arvind Kumar; Vishal, Vindhya; Sikdar, Indranil

2016-01-01

Face mask ventilation of the edentulous patient is often difficult as ineffective seating of the standard mask to the face prevents attainment of an adequate air seal. The efficacy of nasal ventilation in edentulous patients has been cited in case reports but has never been investigated. Consecutive edentulous adult patients scheduled for surgery under general anesthesia with endotracheal intubation, during a 17-month period, were prospectively evaluated. After induction of anesthesia and administration of neuromuscular blocker, lungs were ventilated with a standard anatomical face mask of appropriate size, using a volume controlled anesthesia ventilator with tidal volume set at 10 ml/kg. In case of inadequate ventilation, the mask position was adjusted to achieve best-fit. Inspired and expired tidal volumes were measured. Thereafter, the face mask was replaced by a nasal mask and after achieving best-fit, the inspired and expired tidal volumes were recorded. The difference in expired tidal volumes and airway pressures at best-fit with the use of the two masks and number of patients with inadequate ventilation with use of the masks were statistically analyzed. A total of 79 edentulous patients were recruited for the study. The difference in expiratory tidal volumes with the use of the two masks at best-fit was statistically significant (P = 0.0017). Despite the best-fit mask placement, adequacy of ventilation could not be achieved in 24.1% patients during face mask ventilation, and 12.7% patients during nasal mask ventilation and the difference was statistically significant. Nasal mask ventilation is more efficient than standard face mask ventilation in edentulous patients.

Prospective, multicentre, randomized, double-blind study of the efficacy of escitalopram versus citalopram in outpatient treatment of major depressive disorder.

PubMed

Moore, Nicholas; Verdoux, Hélène; Fantino, Bruno

2005-05-01

Pre-clinical studies, active-control clinical trials and meta-analyses indicate that escitalopram (S-citalopram) might be more effective than citalopram, the racemic mixture of S- and R-citalopram. The present study aimed to confirm the superior efficacy of escitalopram over citalopram. A double-blind, randomized clinical trial was performed in which general practitioners and psychiatrists compared fixed doses of escitalopram (20 mg/day) with citalopram (40 mg/day) over 8 weeks in outpatients with major depressive disorder (MDD) [baseline Montgomery-Asberg Depression Rating Scale (MADRS) score > or =30]. Primary efficacy parameter was change from baseline to last assessment in the MADRS total score. Out of 138 (aged 44.1+/-10.9 years; initial MADRS score 36.3+/-4.8) and 142 (aged 46.2+/-11.1 years; initial MADRS score 35.7+/-4.4) evaluable patients who were randomized to escitalopram and citalopram, respectively, six and 15 withdrew prematurely (P=0.05). The MADRS score decreased more in the escitalopram than in the citalopram arm (-22.4+/-12.9 versus -20.3+/-12.7; P<0.05). There were more treatment responders with escitalopram (76.1%) than with citalopram (61.3%, P<0.01). Adjusted remitter rates were 56.1% and 43.6%, respectively (P<0.05). Tolerability was similar in both groups. This randomized double-blind trial confirms that escitalopram has a superior effect to citalopram in MDD.

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.

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

DTIC Science & Technology

2001-10-01

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

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.

Immediate effects of blood donation on physical and cognitive performance-A randomized controlled double-blinded trial.

PubMed

Eliassen, Håkon S; Hervig, Tor; Backlund, Sebastian; Sivertsen, Joar; Iversen, Vegard Vereide; Kristoffersen, Morten; Wengaard, Eivind; Gramstad, Arne; Fosse, Theodor; Bjerkvig, Christopher K; Apelseth, Torunn; Doughty, Heidi; Strandenes, Geir

2018-06-01

The success of implementing damage control resuscitation principles pre-hospital has been at the expense of several logistic burdens including the requirements for resupply, and the question of donor safety during the development of whole blood programs. Previous studies have reported effects on physical performance after blood donation; however, none have investigated the effects of blood donation on cognitive performance. We describe a prospective double-blinded, randomized, controlled study comprised of a battery of tests: three cognitive tests, and VO2max testing on a cycle ergometer. Testing was performed 7 days before blinded donation (baseline day), immediately after donation (Day 0), and 7 days (Day 7) after donation. The inclusion criteria included being active blood donors at the Haukeland University Hospital blood bank, where eligibility requirements were met on the testing days, and providing informed consent. Participants were randomized to either the experimental (n = 26) or control group (n = 31). Control group participants underwent a 'mock donation" in which a phlebotomy needle was placed but blood was not withdrawn. In the experimental group, mean ± SEM VO2max declined 6% from 41.35 ± 1.7 mLO2/(min·kg) at baseline to 39.0 ± 1.6 mLO2/(min·kg) on Day 0 and increased to 40.51 ± 1.5 mLO2/(min·kg) on Day 7. Comparable values in the control group were 42.1 ± 1.8 mLO2/(min·kg) at baseline, 41.6 ± 1.8 mLO2/(min·kg)) on Day 1 (1% decline from baseline), and 41.8 ± 1.8 mLO2/(min·kg) on Day 7.Comparing scores of all three cognitive tests on Day 0 and Day 7 showed no significant differences (p > 0.05). Our main findings are that executive cognitive and physical performances were well maintained after whole blood donation in healthy blood donors. The findings inform postdonation guidance on when donors may be required to return to duty. Randomized, controlled, double-blinded prospective trial study, level 1.

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.

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.

Ebselen does not improve oxidative stress and vascular function in patients with diabetes: a randomized, crossover trial.

PubMed

Beckman, Joshua A; Goldfine, Allison B; Leopold, Jane A; Creager, Mark A

2016-12-01

Oxidative stress is a key driver of vascular dysfunction in diabetes mellitus. Ebselen is a glutathione peroxidase mimetic. A single-site, randomized, double-masked, placebo-controlled, crossover trial was carried out in 26 patients with type 1 or type 2 diabetes to evaluate effects of high-dose ebselen (150 mg po twice daily) administration on oxidative stress and endothelium-dependent vasodilation. Treatment periods were in random order of 4 wk duration, with a 4-wk washout between treatments. Measures of oxidative stress included nitrotyrosine, plasma 8-isoprostanes, and the ratio of reduced to oxidized glutathione. Vascular ultrasound of the brachial artery and plethysmographic measurement of blood flow were used to assess flow-mediated and methacholine-induced endothelium-dependent vasodilation of conduit and resistance vessels, respectively. Ebselen administration did not affect parameters of oxidative stress or conduit artery or forearm arteriolar vascular function compared with placebo treatment. There was no difference in outcome by diabetes type. Ebselen, at the dose and duration evaluated, does not improve the oxidative stress profile, nor does it affect endothelium-dependent vasodilation in patients with diabetes mellitus. Copyright © 2016 the American Physiological Society.

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.

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.

Prevalence of Gastroesophageal Reflux in Cats During Anesthesia and Effect of Omeprazole on Gastric pH.

PubMed

Garcia, R S; Belafsky, P C; Della Maggiore, A; Osborn, J M; Pypendop, B H; Pierce, T; Walker, V J; Fulton, A; Marks, S L

2017-05-01

Gastroesophageal reflux (GER) is poorly characterized in anesthetized cats, but can cause aspiration pneumonia, esophagitis, and esophageal stricture formation. To determine whether pre-anesthetic orally administered omeprazole increases gastric and esophageal pH and increases serum gastrin concentrations in anesthetized cats, and to determine the prevalence of GER using combined multichannel impedance and pH monitoring. Twenty-seven healthy cats undergoing elective dental procedures. Prospective, double-masked, placebo-controlled, randomized clinical trial. Cats were randomized to receive 2 PO doses of omeprazole (1.45-2.20 mg/kg) or an empty gelatin capsule placebo 18-24 hours and 4 hours before anesthetic induction. Blood for measurement of serum gastrin concentration was collected during anesthetic induction. An esophageal pH/impedance catheter was utilized to continuously measure esophageal pH and detect GER throughout anesthesia. Mean gastric pH in the cats that received omeprazole was 7.2 ± 0.4 (range, 6.6-7.8) and was significantly higher than the pH in cats that received the placebo 2.8 ± 1.0 (range, 1.3-4.1; P < .001). Omeprazole administration was not associated with a significant increase in serum gastrin concentration (P = .616). Nine of 27 cats (33.3%) had ≥1 episode of GER during anesthesia. Pre-anesthetic administration of 2 PO doses of omeprazole at a dosage of 1.45-2.20 mg/kg in cats was associated with a significant increase in gastric and esophageal pH within 24 hours, but was not associated with a significant increase in serum gastrin concentration. Prevalence of reflux events in cats during anesthesia was similar to that of dogs during anesthesia. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

Duration of IOP reduction with travoprost BAK-free solution.

PubMed

Gross, Ronald L; Peace, James H; Smith, Stephen E; Walters, Thomas R; Dubiner, Harvey B; Weiss, Mark J; Ochsner, Katherine I

2008-01-01

To compare the duration of action of travoprost ophthalmic solution 0.004% (Travatan Z) formulated without benzalkonium chloride (BAK) to travoprost ophthalmic solution 0.004% formulated with BAK (Travatan). This was a prospective, randomized, double-masked study. Patients with open-angle glaucoma or ocular hypertension were randomized to receive 2 weeks of once-daily therapy with travoprost BAK-free or travoprost with BAK. Patients received the last dose of medication on day 13 and then intraocular pressure (IOP) was assessed every 12 hours for 60 hours. Statistical analysis included change in IOP from baseline for each group and comparison of mean IOP between groups. Of the 109 patients enrolled, 106 patients completed the study. Untreated mean baseline IOP at 8 AM was 26.9 mm Hg in the travoprost BAK-free group and 27.1 mm Hg in the travoprost with BAK group. At 12, 24, 36, 48, and 60 hours after the last dose, mean IOP in the travoprost BAK-free group was 18.7, 17.2, 19.5, 18.7, and 20.8 mm Hg, respectively; whereas mean IOP in the travoprost with BAK group was 18.5, 16.8, 19.7, 18.0, and 20.8 mm Hg, respectively. Mean IOP at all time points after the last dose of medication was >6 mm Hg lower than the 8 AM baseline in both groups. Between-group differences were within +/-0.6 mm Hg at all postdose time points. There were no statistically significant differences between the 2 treatment groups at baseline or at any postdose time point. Drug-related side effects were uncommon, mild in intensity, and comparable between groups. Travoprost without BAK has similar IOP-lowering efficacy and safety compared with travoprost preserved with BAK. Both formulations of travoprost have a prolonged duration of action, with statistically and clinically significant reductions from baseline persisting up to 60 hours after the last dose.

Perioperative effects of oral midazolam premedication in children undergoing skin laser treatment. A double-blinded randomized placebo-controlled trial.

PubMed

Shoroghi, Mehrdad; Arbabi, Shahriyar; Farahbakhsh, Farshid; Sheikhvatan, Mehrdad; Abbasi, Ali

2011-08-01

To investigate and compare the efficacy of oral midazolam with two different dosages in orange juice on perioperative hemodynamics and behavioral changes in children who underwent skin laser treatment in an academic educational Hospital. Ninety children, candidates for skin laser treatment were randomly assigned to 1 of 3 groups of 30 each: the placebo group received 0.1 ml/kg orange flavored juice, group 2 and 3 receiving 0.5 and 1 mg/kg of injectable midazolam mixed with an equal volume of orange juice, respectively. The main outcome measures included the mask acceptance, patients' behavioral scales and postoperative events. There were no significant differences in heart rate, respiratory rate, and systolic blood pressure among the three groups. However, arterial oxygen saturation was significantly reduced in those given 1 mg.kg(-1) midazolam. The median scores of anxiety, separation from parent, preparing an intravenous line, acceptance of the oxygen mask, good sedation, crying reduction and consciousness level were better in midazolam group. Postoperative agitation and re-crying were also more frequent in placebo receivers. Those given 1 mg.kg(-1) midazolam were significantly more optimal for sedation, crying, consciousness, preparing an intravenous line, and postoperative re-crying compared with 0.5 mg.kg(-1) midazolam receivers. As a preanaesthetic medication, the 1 mg.kg(-1) dose of orally given midazolam especially in a volume of orange juice and can optimize the children's behavior during skin laser treatment with no serious adverse effects, enhancing their parents' satisfactions about the sedative protocol.

Randomized Crossover Trial of Silicone Hydrogel Presbyopic Contact Lenses.

PubMed

Sivardeen, Ahmed; Laughton, Deborah; Wolffsohn, James S

2016-02-01

To assess the performance of four commercially available silicone hydrogel multifocal monthly contact lens designs against monovision. A double-masked randomized crossover trial of Air Optix Aqua multifocal, PureVision 2 for Presbyopia, Acuvue OASYS for Presbyopia, Biofinity multifocal, and monovision with Biofinity contact lenses was conducted on 35 presbyopes (54.3 ± 6.2 years). After 4 weeks of wear, visual performance was quantified by high- and low-contrast visual acuity under photopic and mesopic conditions, reading speed, defocus curves, stereopsis, halometry, aberrometry, Near Activity Visual Questionnaire rating, and subjective quality of vision scoring. Bulbar, limbal, and palpebral hyperemia and corneal staining were graded to monitor the impact of each contact lens on ocular physiology. High-contrast photopic visual acuity (p = 0.102), reading speed (F = 1.082, p = 0.368), and aberrometry (F = 0.855, p = 0.493) were not significantly different between presbyopic lens options. Defocus curve profiles (p < 0.001), stereopsis (p < 0.001), halometry (F = 4.101, p = 0.004), Near Activity Visual Questionnaire (F = 3.730, p = 0.007), quality of vision (p = 0.002), bulbar hyperemia (p = 0.020), and palpebral hyperemia (p = 0.012) differed significantly between lens types, with the Biofinity multifocal lens design principal (center-distance lens was fitted to the dominant eye and a center-near lens to the nondominant eye) typically outperforming the other lenses. Although ocular aberration variation between individuals largely masks the differences in optics between current multifocal contact lens designs, certain design strategies can outperform monovision, even in early presbyopes.

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

Intraoperative Nerve Blocks Fail to Improve Quality of Recovery after Tissue Expander Breast Reconstruction: A Prospective, Double-Blinded, Randomized, Placebo-Controlled Clinical Trial.

PubMed

Lanier, Steven T; Lewis, Kevin C; Kendall, Mark C; Vieira, Brittany L; De Oliveira, Gildasio; Nader, Anthony; Kim, John Y S; Alghoul, Mohammed

2018-03-01

The authors' study represents the first level I evidence to assess whether intraoperative nerve blocks improve the quality of recovery from immediate tissue expander/implant breast reconstruction. A prospective, randomized, double-blinded, placebo-controlled clinical trial was conducted in which patients undergoing immediate tissue expander/implant breast reconstruction were randomized to either (1) intraoperative intercostal and pectoral nerve blocks with 0.25% bupivacaine with 1:200,000 epinephrine and 4 mg of dexamethasone or (2) sham nerve blocks with normal saline. The 40-item Quality of Recovery score, pain score, and opioid use in the postoperative period were compared statistically between groups. Power analysis ensured 80 percent power to detect a 10-point (clinically significant) difference in the 40-item Quality of Recovery score. Forty-seven patients were enrolled. Age, body mass index, laterality, mastectomy type, and lymph node dissection were similar between groups. There were no statistical differences in quality of recovery, pain burden as measured by visual analogue scale, opioid consumption, antiemetic use, or length of hospital stay between groups at 24 hours after surgery. Mean global 40-item Quality of Recovery scores were 169 (range, 155 to 182) for the treatment arm and 165 (range, 143 to 179) for the placebo arm (p = 0.36), indicating a high quality of recovery in both groups. Although intraoperative nerve blocks can be a safe adjunct to a comprehensive postsurgical recovery regimen, the authors' results indicate no effect on overall quality of recovery from tissue expander/implant breast reconstruction. Therapeutic, I.

Treatment of Sjögren's syndrome dry eye using 0.03% tacrolimus eye drop: Prospective double-blind randomized study.

PubMed

Moscovici, Bernardo Kaplan; Holzchuh, Ricardo; Sakassegawa-Naves, Fernando Eiji; Hoshino-Ruiz, Diego Ricardo; Albers, Marcos Bottene Villa; Santo, Ruth Miyuki; Hida, Richard Yudi

2015-10-01

To describe the clinical efficacy of the treatment of Sjögren's syndrome dry eye using 0.03% tacrolimus eye drop. Prospective double-blind randomized study. Institutional outpatient clinic. Forty-eight eyes of twenty-four patients with dry eye related to Sjögren syndrome were enrolled in this study. The patients were randomized in 2 groups: tacrolimus (n=14) and vehicle (n=10) group. The tacrolimus group received a vial containing tacrolimus 0.03% (almond oil as vehicle) and the other group received the almond oil vehicle. All patients were instructed to use the eye drops every 12h in the lower conjunctival sac. Schirmer I test, break-up-time (BUT), corneal fluorescein and Rose Bengal staining scores were evaluated in all patients one day before the treatment (baseline), 7, 14, 28 and 90 days after treatment with the eye drops. The average fluorescein and Rose Bengal scores improved statistically after 7 days of treatment and even more after 90 days. The average Schirmer I and BUT values were unchanged after 7, 14 and 21 days but did show an improvement relative to baseline after 28 days of treatment. Schirmer I, BUT, fluorescein and Rose Bengal did not show any statistical significance in the vehicle group. Topical 0.03% tacrolimus eye drop improved tear stability and ocular surface status in cases of inflammatory or SS-related dry eye. ClinicalTrials.gov Identifier: NCT01850979. Copyright © 2015 British Contact Lens Association. Published by Elsevier Ltd. All rights reserved.

A double-masked, placebo-controlled study of fluoxetine for hypochondriasis.

PubMed

Fallon, Brian A; Petkova, Eva; Skritskaya, Natalia; Sanchez-Lacay, Arturo; Schneier, Franklin; Vermes, Donna; Cheng, Jianfeng; Liebowitz, Michael R

2008-12-01

This study assessed the efficacy, durability, and tolerability of fluoxetine for hypochondriasis, a disorder for which controlled pharmacological trials are scarce. Fifty-seven patients with hypochondriasis were enrolled: 12 discontinued during the placebo run-in, and 45 were randomized to either fluoxetine or placebo for 12 weeks (acute treatment). Responder status was defined as a Clinical Global Impression rating for hypochondriasis of much or very much improved. Secondary outcome measures included severity of hypochondriasis, somatization, anxiety, and depression. Responders to acute treatment entered a 12-week maintenance phase to week 24. Sustained responders at week 24 entered a 12-week double-masked discontinuation phase. Primary analysis used the intent-to-treat sample. More patients responded with improvement in hypochondriasis when given fluoxetine compared with placebo, starting at week 8 (50.0% vs 19.0%, P = 0.03) and continuing to week 12 (62.5% vs 33.3%, P = 0.05). Mean dose at week 12 dose was 51.4 mg (SD, +/-23 mg). The acute treatment response was maintained to week 24 with more responders in the fluoxetine compared with the placebo group (54.2% vs 23.8%, P = 0.04). Significant improvement was not noted on the continuous secondary outcomes measures of hypochondriasis, with the exception of the Clinical Global Impression hypochondriasis severity scale at week 24. Likelihood of response was not associated with severity of psychiatric comorbidity. Durability of response after controlled drug discontinuation could not be reasonably assessed, given the small sample size of patients who entered the discontinuation phase (n = 10). Fluoxetine was well tolerated, with no significant differences in discontinuation due to side effects between treatment groups. Fluoxetine is a moderately effective and well-tolerated treatment for hypochondriasis.

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.

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.

Acute tryptophan depletion attenuates conscious appraisal of social emotional signals in healthy female volunteers

PubMed Central

Gray, Marcus A.; Minati, Ludovico; Whale, Richard; Harrison, Neil A.; Critchley, Hugo D.

2010-01-01

Rationale Acute tryptophan depletion (ATD) decreases levels of central serotonin. ATD thus enables the cognitive effects of serotonin to be studied, with implications for the understanding of psychiatric conditions, including depression. Objective To determine the role of serotonin in conscious (explicit) and unconscious/incidental processing of emotional information. Materials and methods A randomized, double-blind, cross-over design was used with 15 healthy female participants. Subjective mood was recorded at baseline and after 4 h, when participants performed an explicit emotional face processing task, and a task eliciting unconscious processing of emotionally aversive and neutral images presented subliminally using backward masking. Results ATD was associated with a robust reduction in plasma tryptophan at 4 h but had no effect on mood or autonomic physiology. ATD was associated with significantly lower attractiveness ratings for happy faces and attenuation of intensity/arousal ratings of angry faces. ATD also reduced overall reaction times on the unconscious perception task, but there was no interaction with emotional content of masked stimuli. ATD did not affect breakthrough perception (accuracy in identification) of masked images. Conclusions ATD attenuates the attractiveness of positive faces and the negative intensity of threatening faces, suggesting that serotonin contributes specifically to the appraisal of the social salience of both positive and negative salient social emotional cues. We found no evidence that serotonin affects unconscious processing of negative emotional stimuli. These novel findings implicate serotonin in conscious aspects of active social and behavioural engagement and extend knowledge regarding the effects of ATD on emotional perception. PMID:20596858

Enhanced light output from the nano-patterned InP semiconductor substrate through the nanoporous alumina mask.

PubMed

Jung, Mi; Kim, Jae Hun; Lee, Seok; Jang, Byung Jin; Lee, Woo Young; Oh, Yoo-Mi; Park, Sun-Woo; Woo, Deokha

2012-07-01

A significant enhancement in the light output from nano-patterned InP substrate covered with a nanoporous alumina mask was observed. A uniform nanohole array on an InP semiconductor substrate was fabricated by inductively coupled plasma reactive ion etching (ICP-RIE), using the nanoporous alumina mask as a shadow mask. The light output property of the semiconductor substrate was investigated via photoluminescence (PL) intensity measurement. The InP substrate with a nanohole array showed a more enhanced PL intensity compared with the raw InP substrate without a nanohole structure. After ICP-RIE etching, the light output from the nanoporous InP substrate covered with a nanoporous alumina mask showed fourfold enhanced PL intensity compared with the raw InP substrate. These results can be used as a prospective method for increasing the light output efficiency of optoelectronic devices.

Excitation-based and informational masking of a tonal signal in a four-tone masker.

PubMed

Leibold, Lori J; Hitchens, Jack J; Buss, Emily; Neff, Donna L

2010-04-01

This study examined contributions of peripheral excitation and informational masking to the variability in masking effectiveness observed across samples of multi-tonal maskers. Detection thresholds were measured for a 1000-Hz signal presented simultaneously with each of 25, four-tone masker samples. Using a two-interval, forced-choice adaptive task, thresholds were measured with each sample fixed throughout trial blocks for ten listeners. Average thresholds differed by as much as 26 dB across samples. An excitation-based model of partial loudness [Moore, B. C. J. et al. (1997). J. Audio Eng. Soc. 45, 224-237] was used to predict thresholds. These predictions accounted for a significant portion of variance in the data of several listeners, but no relation between the model and data was observed for many listeners. Moreover, substantial individual differences, on the order of 41 dB, were observed for some maskers. The largest individual differences were found for maskers predicted to produce minimal excitation-based masking. In subsequent conditions, one of five maskers was randomly presented in each interval. The difference in performance for samples with low versus high predicted thresholds was reduced in random compared to fixed conditions. These findings are consistent with a trading relation whereby informational masking is largest for conditions in which excitation-based masking is smallest.

Nasal mask ventilation is better than face mask ventilation in edentulous patients

PubMed Central

Kapoor, Mukul Chandra; Rana, Sandeep; Singh, Arvind Kumar; Vishal, Vindhya; Sikdar, Indranil

2016-01-01

Background and Aims: Face mask ventilation of the edentulous patient is often difficult as ineffective seating of the standard mask to the face prevents attainment of an adequate air seal. The efficacy of nasal ventilation in edentulous patients has been cited in case reports but has never been investigated. Material and Methods: Consecutive edentulous adult patients scheduled for surgery under general anesthesia with endotracheal intubation, during a 17-month period, were prospectively evaluated. After induction of anesthesia and administration of neuromuscular blocker, lungs were ventilated with a standard anatomical face mask of appropriate size, using a volume controlled anesthesia ventilator with tidal volume set at 10 ml/kg. In case of inadequate ventilation, the mask position was adjusted to achieve best-fit. Inspired and expired tidal volumes were measured. Thereafter, the face mask was replaced by a nasal mask and after achieving best-fit, the inspired and expired tidal volumes were recorded. The difference in expired tidal volumes and airway pressures at best-fit with the use of the two masks and number of patients with inadequate ventilation with use of the masks were statistically analyzed. Results: A total of 79 edentulous patients were recruited for the study. The difference in expiratory tidal volumes with the use of the two masks at best-fit was statistically significant (P = 0.0017). Despite the best-fit mask placement, adequacy of ventilation could not be achieved in 24.1% patients during face mask ventilation, and 12.7% patients during nasal mask ventilation and the difference was statistically significant. Conclusion: Nasal mask ventilation is more efficient than standard face mask ventilation in edentulous patients. PMID:27625477

Fast mask writers: technology options and considerations

NASA Astrophysics Data System (ADS)

Litt, Lloyd C.; Groves, Timothy; Hughes, Greg

2011-04-01

The semiconductor industry is under constant pressure to reduce production costs even as the complexity of technology increases. Lithography represents the most expensive process due to its high capital equipment costs and the implementation of low-k1 lithographic processes, which have added to the complexity of making masks because of the greater use of optical proximity correction, pixelated masks, and double or triple patterning. Each of these mask technologies allows the production of semiconductors at future nodes while extending the utility of current immersion tools. Low-k1 patterning complexity combined with increased data due to smaller feature sizes is driving extremely long mask write times. While a majority of the industry is willing to accept times of up to 24 hours, evidence suggests that the write times for many masks at the 22 nm node and beyond will be significantly longer. It has been estimated that funding on the order of 50M to 90M for non-recurring engineering (NRE) costs will be required to develop a multiple beam mask writer system, yet the business case to recover this kind of investment is not strong. Moreover, funding such a development poses a high risk for an individual supplier. The structure of the mask fabrication marketplace separates the mask writer equipment customer (the mask supplier) from the final customer (wafer manufacturer) that will be most effected by the increase in mask cost that will result if a high speed mask writer is not available. Since no individual company will likely risk entering this market, some type of industry-wide funding model will be needed.

Anesthetic Efficacy of Articaine and Ketamine for Inferior Alveolar Nerve Block in Symptomatic Irreversible Pulpitis: A Prospective Randomized Double-Blind Study.

PubMed

Sakhaeimanesh, Vahid; Khazaei, Saber; Kaviani, Naser; Saatchi, Masoud; Shafiei, Maryam; Khademi, Abbasali

2017-01-01

The aim of this prospective, randomized, double-blind study was to investigate the effect of articaine combined with ketamine on the success rate of inferior alveolar nerve block (IANB) in posterior mandible teeth with symptomatic irreversible pulpitis. Forty two adult patients with diagnosis of symptomatic irreversible pulpitis of a mandibular posterior tooth were selected. The patients received two cartridges of either containing 3.2 mL 4% articaine with epinephrine 1:200000 and 0.4 mL 50 mg/mL ketamine hydrochloride (A-ketamine group) or 3.2 mL 4% articaine with epinephrine 1:200000 and 0.4 mL normal saline (A-saline group) using conventional IANB injections. Access cavity preparation started 15 min after injection. Lip numbness was required for all the patients. Success was considered as no or mild pain on the basis of Heft-Parker visual analog scale recordings upon access cavity preparation or initial instrumentation. Data were analyzed by independent student t , Mann-Whitney and Chi -square tests. The success rates were 55% and 42.9% for A-ketamine and A-saline group, respectively, with no significant differences between the two groups ( P =0.437) . Adding 0.4 mL 50 mg/mL ketamine hydrochloride to the articaine local anesthetic did not increase the efficacy of IANB for posterior mandibular teeth with symptomatic irreversible pulpitis.

Placebo controlled, prospectively randomized, double-blinded study for the investigation of the effectiveness and safety of the acoustic wave therapy (AWT(®)) for cellulite treatment.

PubMed

Russe-Wilflingseder, Katharina; Russe-Wilfingsleder, Katharina; Russe, Elisabeth; Vester, Johannes C; Haller, Gerd; Novak, Pavel; Krotz, Alexander

2013-06-01

Placebo controlled double-blinded, prospectively randomized clinical trial with 17 patients (11 verum, 5 placebo) for evaluation of cellulite treatment with Acoustic Wave Therapy, (AWT(®)) was performed. The patients were treated once a week for 7 weeks, a total of 8 treatments with the D-ACTOR(®) 200 by Storz Medical AG. Data were collected at baseline, before 8th treatment, at 1 month (follow-up 1) and at 3 months (follow-up 2) after the last treatment with a patients' questionnaire, weight control, measurement of circumference and standardized photography. Treatment progress was further documented using a specially designed 3D imaging system (SkinSCAN(3D), 3D-Shape GmbH) providing an objective measure of cellulite (primary efficacy criteria). Patient's questionnaire in the verum group revealed an improvement in number and depth of dimples, skin firmness and texture, in shape and in reduction of circumference. The overall result (of skin waviness, Sq and Sz, surface and volume of depressions and elevations, Vvv and Vmp) at two follow-up visits indicates a more than medium sized superiority (MW = 0.6706) and is statistically significant (pWei-Lachin = 0.0106). The placebo group revealed no statistical significance. No side effects were seen. This indicates the efficacy and safety of AWT(®) for patients with cellulite.

Effect of Aloe vera topical gel combined with tretinoin in treatment of mild and moderate acne vulgaris: a randomized, double-blind, prospective trial.

PubMed

Hajheydari, Zohreh; Saeedi, Majid; Morteza-Semnani, Katayoun; Soltani, Aida

2014-04-01

Topical retinoids are considered first-line therapy in the treatment of acne vulgaris, yet can be associated with cutaneous irritations. Combination therapy with natural preparations could be effective in treatment and decreasing adverse events. The aim of this study was to compare the efficacy and safety of the combination of tretinoin (TR) cream (0.05%) and Aloe vera topical gel (50%) with TR and vehicle. The randomized, double-blind, prospective 8-week trial evaluated inflammatory and non-inflammatory lesion scores and tolerability in 60 subjects with mild to moderate acne vulgaris (global acne grading system scale). Several formulations of A. vera leaf gel were prepared and the most stable one was selected for clinical study based on physicochemical evaluations. The combination therapy showed superior efficacy to TR and placebo. TR/Aloe vera gel (AVG) was significantly more effective in reducing non-inflammatory (p = 0.001), inflammatory (p = 0.011) and total (p = 0.003) lesion scores than control group. The highest percentage of adverse cutaneous effect was reported for scaling. At the end of study, erythema in the TR/AVG-treated group was significantly less severe (p = 0.046). The combination TR/AVG was well tolerated and significantly more effective than TR and vehicle for the treatment of mild to moderate acne vulgaris.

A prospective, randomized, double-blinded single-site control study comparing blood loss prevention of tranexamic acid (TXA) to epsilon aminocaproic acid (EACA) for corrective spinal surgery

PubMed Central

2010-01-01

Background Multilevel spinal fusion surgery has typically been associated with significant blood loss. To limit both the need for transfusions and co-morbidities associated with blood loss, the use of anti-fibrinolytic agents has been proposed. While there is some literature comparing the effectiveness of tranexamic acid (TXA) to epsilon aminocaproic acid (EACA) in cardiac procedures, there is currently no literature directly comparing TXA to EACA in orthopedic surgery. Methods/Design Here we propose a prospective, randomized, double-blinded control study evaluating the effects of TXA, EACA, and placebo for treatment of adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis (NMS), and adult deformity (AD) via corrective spinal surgery. Efficacy will be determined by intraoperative and postoperative blood loss. Other clinical outcomes that will be compared include transfusion rates, preoperative and postoperative hemodynamic values, and length of hospital stay after the procedure. Discussion The primary goal of the study is to determine perioperative blood loss as a measure of the efficacy of TXA, EACA, and placebo. Based on current literature and the mechanism by which the medications act, we hypothesize that TXA will be more effective at reducing blood loss than EACA or placebo and result in improved patient outcomes. Trial Registration ClinicalTrials.gov ID: NCT00958581 PMID:20370916

Ketamine does not inhibit interleukin-6 synthesis in hepatic resections requiring a temporary porto-arterial occlusion (Pringle manoeuvre): a controlled, prospective, randomized, double-blinded study

PubMed Central

Bonofiglio, Francisco Carlos; Molmenti, Ernesto P; de Santibañes, Eduardo

2011-01-01

Introduction Previous studies have shown that interleukin-6 (IL-6) levels correlated with mortality in critically ill patients. Goal To determine the effect of ketamine on IL-6 levels in liver resections patients with a temporary porto-arterial occlusion (Pringle manoeuvre). Materials and methods Controlled, prospective, randomized, double-blinded study. One group (n = 21) received ketamine whereas the other group (n = 17) received placebo. IL-6 levels were obtained at baseline, 4, 12, 24 h, 3 and 5 days. Results There were no significant differences in IL-6 levels between the groups (basal P = 089, 4 h P = 0.83, 12 h P = 0.39, 24 h, P = 0.55, 3 days P = 0.80 and 5 days P = 0.45). Both groups had elevated IL-6 levels that became almost undetectable by day 5. There was no major morbidity and no mortality in either group. Conclusions Ketamine does not seem to have an effect on plasma levels of IL-6. This could be interpreted as a potential finding associated with outcome as we did not encounter any deaths or major complications. Further studies will likely be needed to determine the range of IL-6 levels associated with survival and mortality, and whether it could be a predictor of survival. PMID:21929671

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.

100-nm gate lithography for double-gate transistors

NASA Astrophysics Data System (ADS)

Krasnoperova, Azalia A.; Zhang, Ying; Babich, Inna V.; Treichler, John; Yoon, Jung H.; Guarini, Kathryn; Solomon, Paul M.

2001-09-01

The double gate field effect transistor (FET) is an exploratory device that promises certain performance advantages compared to traditional CMOS FETs. It can be scaled down further than the traditional devices because of the greater electrostatic control by the gates on the channel (about twice as short a channel length for the same gate oxide thickness), has steeper sub-threshold slope and about double the current for the same width. This paper presents lithographic results for double gate FET's developed at IBM's T. J. Watson Research Center. The device is built on bonded wafers with top and bottom gates self-aligned to each other. The channel is sandwiched between the top and bottom polysilicon gates and the gate length is defined using DUV lithography. An alternating phase shift mask was used to pattern gates with critical dimensions of 75 nm, 100 nm and 125 nm in photoresist. 50 nm gates in photoresist have also been patterned by 20% over-exposure of nominal 100 nm lines. No trim mask was needed because of a specific way the device was laid out. UV110 photoresist from Shipley on AR-3 antireflective layer were used. Process windows, developed and etched patterns are presented.

Joint seismic data denoising and interpolation with double-sparsity dictionary learning

NASA Astrophysics Data System (ADS)

Zhu, Lingchen; Liu, Entao; McClellan, James H.

2017-08-01

Seismic data quality is vital to geophysical applications, so that methods of data recovery, including denoising and interpolation, are common initial steps in the seismic data processing flow. We present a method to perform simultaneous interpolation and denoising, which is based on double-sparsity dictionary learning. This extends previous work that was for denoising only. The original double-sparsity dictionary learning algorithm is modified to track the traces with missing data by defining a masking operator that is integrated into the sparse representation of the dictionary. A weighted low-rank approximation algorithm is adopted to handle the dictionary updating as a sparse recovery optimization problem constrained by the masking operator. Compared to traditional sparse transforms with fixed dictionaries that lack the ability to adapt to complex data structures, the double-sparsity dictionary learning method learns the signal adaptively from selected patches of the corrupted seismic data, while preserving compact forward and inverse transform operators. Numerical experiments on synthetic seismic data indicate that this new method preserves more subtle features in the data set without introducing pseudo-Gibbs artifacts when compared to other directional multi-scale transform methods such as curvelets.

Effect of atorvastatin on progression of sensorineural hearing loss and tinnitus in the elderly: results of a prospective, randomized, double-blind clinical trial.

PubMed

Olzowy, Bernhard; Canis, Martin; Hempel, John-Martin; Mazurek, Birgit; Suckfüll, Markus

2007-06-01

To test whether the 3-hydroxy-3-methylglutaryl- coenzyme A reductase inhibitor atorvastatin can slow down the progression of presbycusis. Fifty patients 60- to 75-years-old with presbycusis and moderately elevated serum cholesterol. In a double-blind design, patients were randomly assigned to treatment with either atorvastatin (40 mg/d orally) or placebo. Pure-tone audiometry and tinnitus evaluation at enrolment and after 7 and 13 months. Development of hearing thresholds after 7 and 13 months showed no significant differences between the groups. Tinnitus score continuously improved in the atorvastatin group (34.8 at 7 and 27.6 at 13 mo), whereas it slightly deteriorated in the placebo group (24.8 at 7 and 26.8 at 13 mo). The effect on tinnitus was a tendency without statistic significance (p = 0.0833). Atorvastatin had no effect on the development of hearing thresholds, but resulted in a trend toward a relief of tinnitus.

A double-blind randomized placebo-controlled feasibility study evaluating individualized homeopathy in managing pain of knee osteoarthritis.

PubMed

Koley, Munmun; Saha, Subhranil; Ghosh, Shubhamoy

2015-07-01

Few homeopathic complexes seemed to produce significant effects in osteoarthritis; still, individualized homeopathy remained untested. We evaluated the feasibility of conducting an efficacy trial of individualized homeopathy in osteoarthritis. A prospective, parallel-arm, double-blind, randomized, placebo-controlled pilot study was conducted from January to October 2014 involving 60 patients (homeopathy, n = 30; placebo, n = 30) who were suffering from acute painful episodes of knee osteoarthritis and visiting the outpatient clinic of Mahesh Bhattacharyya Homeopathic Medical College and Hospital, West Bengal, India. Statistically significant reduction was achieved in 3 visual analog scales (measuring pain, stiffness, and loss of function) and Osteoarthritis Research Society International scores in both groups over 2 weeks (P < .05); however, group differences were not significant (P > .05). Overall, homeopathy did not appear to be superior to placebo; still, further rigorous evaluation in this design involving a larger sample size seems feasible in future. Clinical Trials Registry, India (CTRI/2014/05/004589). © The Author(s) 2015.

Clinical study on the therapeutic role of midodrine in non azotemic cirrhotic patients with tense ascites: a double-blind, placebo-controlled, randomized trial.

PubMed

Ali, Ahmed; Farid, Samar; Amin, Mona; Kassem, Mohamed; Al-Garem, Nouman

2014-10-01

Midodrine is an α-agonist prodrug of desglymidodrine used for the management of hypotension. Midodrine has demonstrated usefulness in hepatorenal syndrome. The objective of the present work was to study the role of midodrine in patients with non-azotemic cirrhosis with tense ascites. This prospective randomized double blind placebo-controlled study was conducted on 67 non azotemic inpatients with liver cirrhosis and tense ascites (52 men and 15 women; age range, 45-72). One patient declined to participate in the study, 33 patients were randomly assigned to take midodrine hydrochloride, and 33 patients were randomly assigned to take placebo. Out of 67 enrolled patients, 60 patients (30: in midodrine group; 30: in placebo group) completed the study and 6 patients lost to follow up. Patients were assessed for patients’ characteristics, history of tapping their ascetic fluid, laboratory values, and Doppler parameters before and after the study. Average 24-h urine volume was assessed before and after the start of the study. significant reduction in body weight and abdominal girth was observed after 2 weeks of midodrine therapy. Midodrine appeared to be effective in lowering body weights and abdominal girths of non azotemic cirrhotic patients with tense ascites.

Topical delta 9-tetrahydrocannabinol and aqueous dynamics in glaucoma.

PubMed

Merritt, J C; Perry, D D; Russell, D N; Jones, B F

1981-01-01

Systemic delta 9-tetrahydrocannabinol (THC), administered either by smoking marihuana or as synthetic THC in soft gelatin capsules, lowers ocular tension in various glaucomas, but at the expense of significant decreases in systolic blood pressure. Topical THC in light mineral oil vehicles, though effective in laboratory animals, was not shown effective in 0.05 and 0.1% topical solutions when administered to six subjects with primary open-angle glaucoma in a randomized, balanced, double-masked protocol. Light mineral oil, which has an affinity for corneal epithelium, is an optimum vehicle for administering drugs whose mechanisms of action are systemic rather than local within the eye. Further glaucoma research should therefore proceed with marihuanas containing insignificant levels of THC (less than 0.4%) and with various local delivery systems of the ocular-active cannabinoid found in Cannabis sativa.

Anesthetic effects from low concentrations of proparacaine and benoxinate.

PubMed

Jauregui, M J; Sanders, T J; Polse, K A

1980-01-01

Using double masking procedures, the response to McKay-Marg and Goldmann tonometry of 361 randomly selected patients was determined following the installation of a single dose of either 0.125, 0.25 or 0.5% proparacaine or 0.1, 0.2 or 0.4% benoxinate. Examiners graded the adequacy, patient tolerance and conjunctival hyperemia induced by the drop, while the subjects reported on the sting of the drop, awareness of the tonometer and discomfort after the procedure. The results indicate that 0.25% proparacaine is an effective anesthetic dose on all patients and that 0.2% benoxinate and 0.125% proparacaine would be effective on patients over age 40. The implication of these results is that significantly lower doses of anesthetic can be used which will result in less stinging, reduced hyperemia and shorter duration of action.

Formation of multiple focal spots using a high NA lens with a complex spiral phase mask

NASA Astrophysics Data System (ADS)

Lalithambigai, K.; Anbarasan, P. M.; Rajesh, K. B.

2014-07-01

The formation of a transversally polarized beam by transmitting a tightly focused double-ring-shaped azimuthally polarized beam through a complex spiral phase mask and high numerical aperture lens is presented based on vector diffraction theory. The generation of transversally polarized focal spot segment splitting and multiple focal spots is illustrated numerically. Moreover, we found that a properly designed complex spiral phase mask can move the focal spots along the optical axis in the z direction. Therefore, one can achieve a focal segment of two, three or multiple completely transversely polarized focal spots, which finds applications in optical trapping and in material processing technologies.

Continuous positive airway pressure with helmet versus mask in infants with bronchiolitis: an RCT.

PubMed

Chidini, Giovanna; Piastra, Marco; Marchesi, Tiziana; De Luca, Daniele; Napolitano, Luisa; Salvo, Ida; Wolfler, Andrea; Pelosi, Paolo; Damasco, Mirco; Conti, Giorgio; Calderini, Edoardo

2015-04-01

Noninvasive continuous positive airway pressure (CPAP) is usually applied with a nasal or facial mask to treat mild acute respiratory failure (ARF) in infants. A pediatric helmet has now been introduced in clinical practice to deliver CPAP. This study compared treatment failure rates during CPAP delivered by helmet or facial mask in infants with respiratory syncytial virus-induced ARF. In this multicenter randomized controlled trial, 30 infants with respiratory syncytial virus-induced ARF were randomized to receive CPAP by helmet (n = 17) or facial mask (n = 13). The primary endpoint was treatment failure rate (defined as due to intolerance or need for intubation). Secondary outcomes were CPAP application time, number of patients requiring sedation, and complications with each interface. Compared with the facial mask, CPAP by helmet had a lower treatment failure rate due to intolerance (3/17 [17%] vs 7/13 [54%], P = .009), and fewer infants required sedation (6/17 [35%] vs 13/13 [100%], P = .023); the intubation rates were similar. In successfully treated patients, CPAP resulted in better gas exchange and breathing pattern with both interfaces. No major complications due to the interfaces occurred, but CPAP by mask had higher rates of cutaneous sores and leaks. These findings confirm that CPAP delivered by helmet is better tolerated than CPAP delivered by facial mask and requires less sedation. In addition, it is safe to use and free from adverse events, even in a prolonged clinical setting. Copyright © 2015 by the American Academy of Pediatrics.

Prospective, randomized comparison of a prototype endoscope with deflecting working channels versus a conventional double-channel endoscope for rectal endoscopic submucosal dissection in an established experimental simulation model (with video).

PubMed

Jung, Yunho; Kato, Masayuki; Lee, Jongchan; Gromski, Mark A; Chuttani, Ram; Matthes, Kai

2013-11-01

A prototype endoscope was designed to improve visualization and dissection of tissue with the use of 2 working channels with different deflections. To evaluate the efficacy and operability of a prototype endoscope in comparison with a conventional double-channel endoscope for rectal endoscopic submucosal dissection (ESD). Randomized, prospective, controlled, ex vivo study. Academic medical center. A total of 80 standardized artificial lesions measuring 3 × 3 cm were created approximately 5 cm from the anal verge in fresh ex vivo porcine colorectal specimens. Two endoscopists each completed 20 cases with the prototype endoscope and 20 cases with the conventional endoscope. An independent observer recorded procedure time, specimen size, en bloc resection, and perforation rate. For the ESD novice, the mean submucosal dissection time (10.5 ± 3.8 vs 14.9 ± 7.3 minutes; P = .024) and total procedure time (18.1 ± 5.2 vs 23.6 ± 8.2 minutes; P = .015) were significantly shorter in the prototype group in comparison with the conventional group. For the ESD expert, there was no significant difference between the mean circumferential resection, submucosal dissection, and total procedure time (prototype group 14.2 ± 6.0 minutes, conventional group 14.2 ± 8.8 minutes; P = .992). The overall perforation and en bloc resection rates were not significantly different between groups. Ex vivo study. In this ex vivo prospective comparison study, there was a technical advantage for the ESD novice with the prototype endoscope that resulted in a shorter procedure time, which was not observed for cases performed by the ESD expert. Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

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 the effects of magnesium and ketamine on postoperative pain and morphine consumption. A double-blind randomized controlled clinical study.

PubMed

Arıkan, Müge; Aslan, Bilge; Arıkan, Osman; Horasanlı, Eyüp; But, Abdulkadir

2016-01-01

To compare the effects of magnesium sulfate and ketamine on postoperative pain and total morphine consumption in a placebo-controlled design. One hundred and twenty women scheduled for total abdominal hysterectomy were included in this prospective, randomized, double-blind study. Postoperatively, when the Numeric Pain Rating Scale (NPRS) was four or more, IV-PCA morphine was applied to all patients. The patients were randomized into three groups: Group K ketamine, Group M magnesium, and Group C saline received as infusion. Total morphine consumption for 48h, pain scores, adverse effects, and patients' satisfaction were evaluated. Total morphine consumption was significantly lower in Group K (32.6±9.2 mg) than in Group M (58.9±6.5 mg) and in Group C (65.7±8.2 mg). The satisfaction level of patients in Group K was higher than the other two groups (p<0.05). Pruritus and nausea were observed more frequently in Group C. CONCLUSİON: The addition of ketamine to IV-PCA morphine reduces the total consumption of morphine without psychotic effects; however, magnesium did not influence morphine consumption.

Efficacy of Trimetazidine Dihydrochloride for Relieving Chronic Tinnitus: A Randomized Double-Blind Study

PubMed Central

Kumral, Tolgar Lütfi; Yıldırım, Güven; Berkiten, Güler; Saltürk, Ziya; Ataç, Enes; Atar, Yavuz; Uyar, Yavuz

2016-01-01

Objectives. To evaluate the efficacy of trimetazidine dihydrochloride as a treatment for chronic tinnitus. Methods. A total of 97 chronic tinnitus patients were evaluated in this randomized, prospective, double-blind, placebo-controlled trial. After assessing for eligibility, 82 patients were randomly assigned into placebo or trimetazidine groups according to the medication. The trimetazidine group received 20×3 mg/day per oral trimetazidine dihydrochloride and the placebo group received 20×3 mg/day per oral placebo for 3 months. Tinnitus handicap inventory (THI), visual analogue scale (VAS) questionnaires and audiometric results were used to determine the effectiveness of trimetazidine treatment. Results. The study group comprised 82 tinnitus subjects, 42 (51%) of whom received trimetazidine dihydrochloride and 40 (49%) who received placebo. There was no significant difference between placebo and trimetazidine groups in THI grade and VAS (both pre- and posttreatment scores) (P>0.05) and no significant improvement was observed in subjective loudness score in either group (P>0.05). Additionally there was no significant difference between groups in pre- and posttreatment pure tone hearing thresholds at all measured frequencies (P>0.05). Conclusion. Trimetazidine dihydrochloride therapy was ineffective for relieving chronic tinnitus. PMID:27230273

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.

Effect of Noninvasive Ventilation Delivered by Helmet vs Face Mask on the Rate of Endotracheal Intubation in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial.

PubMed

Patel, Bhakti K; Wolfe, Krysta S; Pohlman, Anne S; Hall, Jesse B; Kress, John P

2016-06-14

Noninvasive ventilation (NIV) with a face mask is relatively ineffective at preventing endotracheal intubation in patients with acute respiratory distress syndrome (ARDS). Delivery of NIV with a helmet may be a superior strategy for these patients. To determine whether NIV delivered by helmet improves intubation rate among patients with ARDS. Single-center randomized clinical trial of 83 patients with ARDS requiring NIV delivered by face mask for at least 8 hours while in the medical intensive care unit at the University of Chicago between October 3, 2012, through September 21, 2015. Patients were randomly assigned to continue face mask NIV or switch to a helmet for NIV support for a planned enrollment of 206 patients (103 patients per group). The helmet is a transparent hood that covers the entire head of the patient and has a rubber collar neck seal. Early trial termination resulted in 44 patients randomized to the helmet group and 39 to the face mask group. The primary outcome was the proportion of patients who required endotracheal intubation. Secondary outcomes included 28-day invasive ventilator-free days (ie, days alive without mechanical ventilation), duration of ICU and hospital length of stay, and hospital and 90-day mortality. Eighty-three patients (45% women; median age, 59 years; median Acute Physiology and Chronic Health Evaluation [APACHE] II score, 26) were included in the analysis after the trial was stopped early based on predefined criteria for efficacy. The intubation rate was 61.5% (n = 24) for the face mask group and 18.2% (n = 8) for the helmet group (absolute difference, -43.3%; 95% CI, -62.4% to -24.3%; P < .001). The number of ventilator-free days was significantly higher in the helmet group (28 vs 12.5, P < .001). At 90 days, 15 patients (34.1%) in the helmet group died compared with 22 patients (56.4%) in the face mask group (absolute difference, -22.3%; 95% CI, -43.3 to -1.4; P = .02). Adverse events included 3 interface-related skin ulcers for each group (ie, 7.6% in the face mask group had nose ulcers and 6.8% in the helmet group had neck ulcers). Among patients with ARDS, treatment with helmet NIV resulted in a significant reduction of intubation rates. There was also a statistically significant reduction in 90-day mortality with helmet NIV. Multicenter studies are needed to replicate these findings. clinicaltrials.gov Identifier: NCT01680783.

Electrochemical Micromachining with Fiber Laser Masking for 304 Stainless Steel

NASA Astrophysics Data System (ADS)

Li, Xiaohai; Wang, Shuming; Wang, Dong; Tong, Han

2017-10-01

In order to fabricate micro structure, the combined machining of electrochemical micro machining (EMM) and laser masking for 304 stainless steel was studied. A device of composite machining of EMM with laser masking was developed, and the experiments of EMM with laser masking were carried out. First, by marking pattern with fiber laser on the surface of 304 stainless steel, the special masking layer can be formed. Through X ray photoelectron spectroscopy (XPS), the corrosion resistance of laser masking layer was analyzed. It is proved by XPS that the iron oxide and chromium oxide on the surface of stainless steel generates due to air oxidation when laser scanning heats. Second, the localization and precision of EMM are improved, since the marking patterns forming on the surface of stainless steel by laser masking play a protective role in the process of subsequent EMM when the appropriate parameters of EMM are selected. At last, the shape and the roughness of the machined samples were measured by SEM and optical profilometer and analyzed. The results show that the rapid fabrication of micro structures on the 304 stainless steel surface can be achieved by EMM with fiber laser masking, which has a good prospect in the field of micro machining.

Fabrication of Fiber-Optic Tilted Bragg Grating Filter in 40 nm Range with A Single Phase Mask

NASA Technical Reports Server (NTRS)

Grant, Joseph; Wang, Y.; Sharma, A.; Burdine, Robert V. (Technical Monitor)

2002-01-01

Fiber-optic Bragg grating filters are fabricated with a range of Bragg wavelength between 1296 and 1336 nm, using a single phase mask. 30 mW of continuous-wave light at 244 nm is used from a frequency-doubled argon-ion laser having an intracavity etalon. Gratings are fabricated by tilting the photosensitive fiber with respect to the phase mask up to an angle of 15 degrees. The variation of Bragg wavelength with the fiber-tilt is explained with a simple formula. High spatial coherence of 244 nm light makes it possible to displace the fiber as much as 6 mm in front of the phase mask and tilt the fiber by as much as 15 degrees. This results in nearly constant band-width and near 100% reflectively for all gratings throughout the 40 nm range.

Exploring the contributions of the supplementary eye field to subliminal inhibition using double-pulse transcranial magnetic stimulation.

PubMed

Chiau, Hui-Yan; Muggleton, Neil G; Juan, Chi-Hung

2017-01-01

It is widely accepted that the supplementary eye fields (SEF) are involved in the control of voluntary eye movements. However, recent evidence suggests that SEF may also be important for unconscious and involuntary motor processes. Indeed, Sumner et al. ([2007]: Neuron 54:697-711) showed that patients with micro-lesions of the SEF demonstrated an absence of subliminal inhibition as evoked by masked-prime stimuli. Here, we used double-pulse transcranial magnetic stimulation (TMS) in healthy volunteers to investigate the role of SEF in subliminal priming. We applied double-pulse TMS at two time windows in a masked-prime task: the first during an early phase, 20-70 ms after the onset of the mask but before target presentation, during which subliminal inhibition is present; and the second during a late phase, 20-70 ms after target onset, during which the saccade is being prepared. We found no effect of TMS with the early time window of stimulation, whereas a reduction in the benefit of an incompatible subliminal prime stimulus was found when SEF TMS was applied at the late time window. These findings suggest that there is a role for SEF related to the effects of subliminal primes on eye movements, but the results do not support a role in inhibiting the primed tendency. Hum Brain Mapp 38:339-351, 2017. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

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.

In-die photomask registration and overlay metrology with PROVE using 2D correlation methods

NASA Astrophysics Data System (ADS)

Seidel, D.; Arnz, M.; Beyer, D.

2011-11-01

According to the ITRS roadmap, semiconductor industry drives the 193nm lithography to its limits, using techniques like double exposure, double patterning, mask-source optimization and inverse lithography. For photomask metrology this translates to full in-die measurement capability for registration and critical dimension together with challenging specifications for repeatability and accuracy. Especially, overlay becomes more and more critical and must be ensured on every die. For this, Carl Zeiss SMS has developed the next generation photomask registration and overlay metrology tool PROVE® which serves the 32nm node and below and which is already well established in the market. PROVE® features highly stable hardware components for the stage and environmental control. To ensure in-die measurement capability, sophisticated image analysis methods based on 2D correlations have been developed. In this paper we demonstrate the in-die capability of PROVE® and present corresponding measurement results for shortterm and long-term measurements as well as the attainable accuracy for feature sizes down to 85nm using different illumination modes and mask types. Standard measurement methods based on threshold criteria are compared with the new 2D correlation methods to demonstrate the performance gain of the latter. In addition, mask-to-mask overlay results of typical box-in-frame structures down to 200nm feature size are presented. It is shown, that from overlay measurements a reproducibility budget can be derived that takes into account stage, image analysis and global effects like mask loading and environmental control. The parts of the budget are quantified from measurement results to identify critical error contributions and to focus on the corresponding improvement strategies.

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.

Expanding the printable design space for lithography processes utilizing a cut mask

NASA Astrophysics Data System (ADS)

Wandell, Jerome; Salama, Mohamed; Wilkinson, William; Curtice, Mark; Feng, Jui-Hsuan; Gao, Shao Wen; Asthana, Abhishek

2016-03-01

The utilization of a cut-mask in semiconductor patterning processes has been in practice for logic devices since the inception of 32nm-node devices, notably with unidirectional gate level printing. However, the microprocessor applications where cut-mask patterning methods are used are expanding as Self-Aligned Double Patterning (SADP) processes become mainstream for 22/14nm fin diffusion, and sub-14nm metal levels. One common weakness for these types of lithography processes is that the initial pattern requiring the follow-up cut-mask typically uses an extreme off-axis imaging source such as dipole to enhance the resolution and line-width roughness (LWR) for critical dense patterns. This source condition suffers from poor process margin in the semi-dense (forbidden pitch) realm and wrong-way directional design spaces. Common pattern failures in these limited design regions include bridging and extra-printing defects that are difficult to resolve with traditional mask improvement means. This forces the device maker to limit the allowable geometries that a designer may use on a device layer. This paper will demonstrate methods to expand the usable design space on dipole-like processes such as unidirectional gate and SADP processes by utilizing the follow-up cut mask to improve the process window. Traditional mask enhancement means for improving the process window in this design realm will be compared to this new cut-mask approach. The unique advantages and disadvantages of the cut-mask solution will be discussed in contrast to those customary methods.

[Laparoscopic Proximal Gastrectomy as a Surgical Treatment for Upper Third Early Gastric Cancer].

PubMed

Park, Do Joong; Park, Young Suk; Ahn, Sang Hoon; Kim, Hyung Ho

2017-09-25

Recently, the incidence of upper third gastric cancer has increased, and with it the number of endoscopic submucosal dissection (ESD) procedures performed has been increasing. However, if ESD is not indicated or non-curable, surgical treatment may be necessary. In the case of lower third gastric cancer, it is possible to preserve the upper part of the stomach; however, in the case of upper third gastric cancer, total gastrectomy is still the standard treatment option, regardless of the stage. This is due to the complications associated with upper third gastric cancer, such as gastroesophageal reflux after proximal gastrectomy rather than oncologic problems. Recently, the introduction of the double tract reconstruction method after proximal gastrectomy has become one of the surgical treatment methods for upper third early gastric cancer. However, since there has not been a prospective comparative study evaluating its efficacy, the ongoing multicenter prospective randomized controlled trial (KLASS-05) comparing laparoscopic proximal gastrectomy with double tract reconstruction and laparoscopic total gastrectomy is expected to be important for determining the future of treatment of upper third early gastric cancer.

Clinical Evaluation of a Royal Jelly Supplementation for the Restoration of Dry Eye: A Prospective Randomized Double Blind Placebo Controlled Study and an Experimental Mouse Model

PubMed Central

Inoue, Sachiko; Kawashima, Motoko; Hisamura, Ryuji; Imada, Toshihiro; Izuta, Yusuke; Nakamura, Shigeru; Ito, Masataka; Tsubota, Kazuo

2017-01-01

Background Dry eye is a multifactorial disease characterized by ocular discomfort and visual impairment. Lacrimal gland function has been shown to decrease with aging, a known potent risk factor for dry eye. We have previously found that orally administrated royal jelly (RJ) restored tear secretion in a rat model of dry eye. Methods and Findings We examined the effects of RJ oral administration on dry eye in this prospective, randomized, double-blind, placebo-controlled study. Forty-three Japanese patients aged 20–60 years with subjective dry eye symptoms were randomized to an RJ group (1200 mg/tablet, six tablets daily) or a placebo group for 8 weeks. Keratoconjunctival epithelial damage, tear film break-up time, tear secretion volume, meibum grade, biochemical data, and subjective dry eye symptoms based on a questionnaire were investigated at baseline, and at 4 and 8 weeks after intervention. Adverse events were reported via medical interviews. In the RJ group, tear volume significantly increased after intervention (p = 0.0009). In particular, patients with a baseline Schirmer value of ≤10 mm showed a significant increase compared with baseline volume (p = 0.0005) and volume in the placebo group (p = 0.0051). No adverse events were reported. We also investigated the effect of RJ (300 mg/kg per day) administration using a mouse model of dry eye. Orally repeated administration of RJ preserved tear secretion, potentially through direct activation of the secretory function of the lacrimal glands. Conclusion Our results suggest that RJ improves tear volume in patients with dry eye. Trial Registration Registered NO. the University Hospital Medical Information Network in Japan (UMIN000014446) PMID:28060936

Effect of a Combination of Intranasal Ketorolac and Nitrous Oxide on the Success of the Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Randomized, Double-blind Study.

PubMed

Stentz, Daniel; Drum, Melissa; Reader, Al; Nusstein, John; Fowler, Sara; Beck, Mike

2018-01-01

Previous studies in patients with irreversible pulpitis have reported increased success of the inferior alveolar nerve block (IANB) using premedication with ketorolac. Preemptive nitrous oxide administration has also shown an increase in the success of the IANB. Recently, ketorolac has been made available for intranasal delivery. Perhaps combining ketorolac and nitrous oxide would increase success. Therefore, the purpose of this prospective, randomized, double-blind study was to determine the effect of a combination of intranasal ketorolac and nitrous oxide/oxygen on the anesthetic success of the IANB in patients presenting with symptomatic irreversible pulpitis. One hundred two patients experiencing spontaneous moderate to severe pain with symptomatic irreversible pulpitis in a mandibular posterior tooth participated. Patients were randomly divided into 2 groups and received either 31.5 mg intranasal ketorolac or intranasal saline placebo 20 minutes before the administration of nitrous oxide/oxygen. Ten minutes after the administration of nitrous oxide/oxygen, the IANB was given. After profound lip numbness, endodontic treatment was performed. Success was defined as the ability to perform endodontic access and instrumentation with no pain or mild pain. The odds of success for the IANB was 1.631 in the intranasal saline/nitrous oxide group versus the intranasal ketorolac/nitrous oxide group with no significant difference between the groups (P = .2523). Premedication with intranasal ketorolac did not significantly increase the odds of success for the IANB over the use of nitrous oxide/oxygen alone. Supplemental anesthesia will still be needed to achieve adequate anesthesia. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Early Removal of Double-J Stents Decreases Urinary Tract Infections in Living Donor Renal Transplantation: A Prospective, Randomized Clinical Trial.

PubMed

Liu, S; Luo, G; Sun, B; Lu, J; Zu, Q; Yang, S; Zhang, X; Dong, J

2017-03-01

The optimal timing for stent removal after renal transplantation remains controversial. This article describes an interim analysis of a randomized, prospective, double-blind trial aimed at detecting differences in urological complications between early ureteral stent removal at 1 week and routine ureteral stent removal at 4 weeks. Between October 2010 and March 2015, 103 patients who underwent living donor renal transplantation at a single center were pre-operatively randomly assigned to the early ureteral stent removal (at 1 week) group or the routine ureteral stent removal (at 4 weeks) group. Urinary symptoms, auxiliary examination results, and obstruction events were recorded during 3 months of follow-up. A cost analysis of both the hospitalization and postoperative periods was discussed. In total, 52 patients in the 1-week stent group and 51 patients in the 4-week stent group were analyzed. No serious adverse events were reported. Three episodes of urinary tract infections (UTIs) occurred in the 1-week stent group, and 18 such episodes were recorded in the 4-week stent group (5.8% vs 29.4%; P = .002). After adjusting for age, sex, ischemia time, renal artery number, body mass index, multiple arteries, and associated medical illness, regression analysis indicated that only stent duration was associated with UTI (OR, 8.791; 95% CI, 1.984-38.943; P = .004). The results of our study demonstrate that ureteral stent removal at 1 week reduces the risk of UTIs compared with routine removal at 4 weeks. Similar effects of ureteral stent removal on complication rates are observed for these two removal times. Copyright © 2016 Elsevier Inc. All rights reserved.

Effects of low-intensity pulsed ultrasound on radiographic healing of tibial plateau leveling osteotomies in dogs: a prospective, randomized, double-blinded study.

PubMed

Kieves, Nina R; Canapp, Sherman O; Lotsikas, Peter J; Christopher, Scott A; Leasure, Christopher S; Canapp, Debra; Gavin, Patrick R

2018-05-20

To determine the influence of low-intensity pulsed ultrasound (LIPUS) on radiographic healing and limb function after uncomplicated, stable osteotomies in dogs. In vivo, prospective, randomized, double-blinded, placebo-control study. Fifty client-owned dogs. Fifty client-owned dogs with naturally occurring unilateral cranial cruciate ligament rupture were enrolled prior to tibial plateau leveling osteotomy. Dogs were assigned to an active (LIPUS) treatment group or a placebo control (SHAM) treatment group via block randomization on the basis of age, weight, and affected limb. Dogs in the LIPUS treatment group underwent LIPUS treatments for 20 minutes daily: 1.5-MHZ ultrasound wave pulsed at 1 kHZ with a 20% duty cycle at an intensity of 30 mW/cm 2 for the duration of the study (12 weeks). Radiographic evaluation was performed at 4, 8, 10, and 12 weeks postoperatively to evaluate bone healing. Limb function was assessed with temporal-spatial gait analysis preoperatively and at 4, 8, and 12 weeks postoperatively by using a pressure-sensitive walkway system. Both groups had significant improvement in radiographic score and limb use over time. However, there was no significant difference in radiographic bone healing, or limb use as measured by objective gait analysis detected between the LIPUS treatment group and SHAM treatment group at any point in the study. LIPUS treatment did not improve healing in this stable osteotomy model. This study does not provide evidence to support the clinical application of LIPUS to stimulate the healing of stable, uncomplicated osteotomies to accelerate bone healing. © 2018 The American College of Veterinary Surgeons.

Clinical Evaluation of a Royal Jelly Supplementation for the Restoration of Dry Eye: A Prospective Randomized Double Blind Placebo Controlled Study and an Experimental Mouse Model.

PubMed

Inoue, Sachiko; Kawashima, Motoko; Hisamura, Ryuji; Imada, Toshihiro; Izuta, Yusuke; Nakamura, Shigeru; Ito, Masataka; Tsubota, Kazuo

2017-01-01

Dry eye is a multifactorial disease characterized by ocular discomfort and visual impairment. Lacrimal gland function has been shown to decrease with aging, a known potent risk factor for dry eye. We have previously found that orally administrated royal jelly (RJ) restored tear secretion in a rat model of dry eye. We examined the effects of RJ oral administration on dry eye in this prospective, randomized, double-blind, placebo-controlled study. Forty-three Japanese patients aged 20-60 years with subjective dry eye symptoms were randomized to an RJ group (1200 mg/tablet, six tablets daily) or a placebo group for 8 weeks. Keratoconjunctival epithelial damage, tear film break-up time, tear secretion volume, meibum grade, biochemical data, and subjective dry eye symptoms based on a questionnaire were investigated at baseline, and at 4 and 8 weeks after intervention. Adverse events were reported via medical interviews. In the RJ group, tear volume significantly increased after intervention (p = 0.0009). In particular, patients with a baseline Schirmer value of ≤10 mm showed a significant increase compared with baseline volume (p = 0.0005) and volume in the placebo group (p = 0.0051). No adverse events were reported. We also investigated the effect of RJ (300 mg/kg per day) administration using a mouse model of dry eye. Orally repeated administration of RJ preserved tear secretion, potentially through direct activation of the secretory function of the lacrimal glands. Our results suggest that RJ improves tear volume in patients with dry eye. Registered NO. the University Hospital Medical Information Network in Japan (UMIN000014446).

The EMPOWER study: randomized, prospective, double-blind, multicenter trial of vagal blockade to induce weight loss in morbid obesity.

PubMed

Sarr, Michael G; Billington, Charles J; Brancatisano, Roy; Brancatisano, Anthony; Toouli, James; Kow, Lilian; Nguyen, Ninh T; Blackstone, Robin; Maher, James W; Shikora, Scott; Reeds, Dominic N; Eagon, J Christopher; Wolfe, Bruce M; O'Rourke, Robert W; Fujioka, Ken; Takata, Mark; Swain, James M; Morton, John M; Ikramuddin, Sayeed; Schweitzer, Michael; Chand, Bipan; Rosenthal, Raul

2012-11-01

Intermittent, reversible intraabdominal vagal blockade (VBLOC® Therapy) demonstrated clinically important weight loss in feasibility trials. EMPOWER, a randomized, double-blind, prospective, controlled trial was conducted in USA and Australia. Five hundred three subjects were enrolled at 15 centers. After informed consent, 294 subjects were implanted with the vagal blocking system and randomized to the treated (n = 192) or control (n = 102) group. Main outcome measures were percent excess weight loss (percent EWL) at 12 months and serious adverse events. Subjects controlled duration of therapy using an external power source; therapy involved a programmed algorithm of electrical energy delivered to the subdiaphragmatic vagal nerves to inhibit afferent/efferent vagal transmission. Devices in both groups performed regular, low-energy safety checks. Data are mean ± SEM. Study subjects consisted of 90 % females, body mass index of 41 ± 1 kg/m(2), and age of 46 ± 1 years. Device-related complications occurred in 3 % of subjects. There was no mortality. 12-month percent EWL was 17 ± 2 % for the treated and 16 ± 2 % for the control group. Weight loss was related linearly to hours of device use; treated and controls with ≥ 12 h/day use achieved 30 ± 4 and 22 ± 8 % EWL, respectively. VBLOC® therapy to treat morbid obesity was safe, but weight loss was not greater in treated compared to controls; clinically important weight loss, however, was related to hours of device use. Post-study analysis suggested that the system electrical safety checks (low charge delivered via the system for electrical impedance, safety, and diagnostic checks) may have contributed to weight loss in the control group.

Effect of preemptive intra-articular morphine and ketamine on pain after arthroscopic rotator cuff repair: a prospective, double-blind, randomized controlled study.

PubMed

Khashan, M; Dolkart, O; Amar, E; Chechik, O; Sharfman, Z; Mozes, G; Maman, E; Weinbroum, A A

2016-02-01

Rotator cuff tear is a leading etiology of shoulder pain and disability. Surgical treatment is indicated in patients with persistent pain who fail a trial of non-surgical treatment. Pain reduction following rotator cuff repair, particularly within the first 24-48 h, is a major concern to both doctors and patients. This study aimed to compare the postoperative antinociceptive additive effects of pre-incisional intra-articular (IA) ketamine when combined with morphine with two times the dose of morphine or saline. In this prospective, randomized, double blind, controlled trial patients undergoing arthroscopic rotator cuff tear repair (ARCR) under general anesthesia were enrolled. Patients were randomly assigned to one of the three intervention groups. Twenty minutes prior to incision, morphine (20 mg/10 ml), ketamine (50 mg + morphine 10 mg/10 ml), or saline (0.9 % 10 ml) (n = 15/group), were administered to all patients. First 24 h postoperative analgesia consisted of intravenous patient controlled analgesia (IV-PCA) morphine and oral rescue paracetamol 1000 mg or oxycodone 5 mg. 24-h, 2-week and 3-month patient rated pain numeric rating scale (NRS) and analgesics consumption were documented. Patients' demographic and perioperative data were similar among all groups. The 24-h and the 2-week NRSs were significantly (p < 0.05) lower in both treatment groups compared to placebo, but were not significantly different between the two intervention groups. PCA-morphine and oral analgesics were consumed similarly among the groups throughout the study phases. Pre-incisional intra-articular morphine reduced pain in the first 2 weeks after arthroscopic rotator cuff repair. Further research is warranted to elucidate the optimal timing and dosing of IA ketamine and morphine for postoperative analgesic effects.

Intravenous parecoxib and continuous femoral block for postoperative analgesia after total knee arthroplasty. A randomized, double-blind, prospective trial.

PubMed

Sarridou, Despoina G; Chalmouki, Georgia; Braoudaki, Maria; Koutsoupaki, Anna; Mela, Argiro; Vadalouka, Athina

2015-01-01

Up until now, the optimal strategy for postoperative pain management after total knee arthroplasty (TKA) remains to be elucidated. The current investigation aimed to examine the analgesic efficacy and the opioid sparing effects of intravenous parecoxib in combination with continuous femoral blockade. Randomized, double-blind, prospective trial. University hospital in the United Kingdom. In total, 90 patients underwent TKA under subarachnoid anesthesia and received continuous femoral block initially as a bolus with 20 mL of ropivacaine 0.75%. Infusion of 0.2% on 10 mL/h followed. Patients were randomized into 2 groups. Group D and Group P received parecoxib and placebo, respectively at 12 hour time intervals. Visual analog scale (VAS) pain scores were obtained at different time intervals including 4, 8, 12, 24 and 36 hours. The pain scores were measured with patients in a resting position. Morphine could also be administered with a patient controlled analgesia (PCA) pump if the specified analgesia was deemed inadequate (VAS > 5). None of the patients were withdrawn from the study. Parecoxib provided greater relief than placebo following TKA. The VAS pain scores measured at rest were statistically significantly lower in parecoxib-treated patients compared to the placebo group (P = 0.007) at 4 (P = 0.044), 12 (P = 0.001), and 24 hours (P = 0.012), postoperatively. Patients receiving parecoxib consumed less morphine at all time intervals than patients receiving placebo, with borderline statistical significance (P = 0.054). In each time period, all patients receiving continuous femoral block irrespectively of the treatment group, required low morphine doses. Current protocol did not answer question as to functional recovery. According to our findings intravenous parecoxib in combination with continuous femoral block provided superior analgesic efficacy and opioid sparing effects in patients undergoing TKA.

Optimal intrathecal hyperbaric bupivacaine dose with opioids for cesarean delivery: a prospective double-blinded randomized trial.

PubMed

Onishi, Eiko; Murakami, Mamoru; Hashimoto, Keiji; Kaneko, Miho

2017-05-01

Single-shot spinal anesthesia is commonly used for cesarean delivery. Achieving adequate anesthesia throughout surgery needs to be balanced with associated complications. We investigated the optimal dose of intrathecal hyperbaric bupivacaine, co-administered with opioids, for anesthesia for cesarean delivery. This prospective, randomized, double-blinded, dose-ranging trial included parturients scheduled to undergo cesarean delivery under spinal anesthesia. An epidural catheter was first inserted at the T11-12 vertebral interspace, followed by spinal anesthesia at the L2-3 or L3-4 vertebral interspace. Subjects were randomly assigned to one of seven doses of intrathecal hyperbaric bupivacaine 0.5% (6, 7, 8, 9, 10, 11 or 12mg), with added 15μg fentanyl and 75μg morphine. Successful induction of anesthesia (success ind ) was defined as achievement of bilateral sensory loss to cold at the T6 dermatome or higher, within 10 minutes. Successful maintenance of anesthesia (success main ) was defined by no epidural supplementation within 60 minutes of intrathecal injection. The effective doses for 50% (ED 50 ) and 95% (ED 95 ) of patients were estimated using logistic regression analysis. The ED 50 and ED 95 for success main were 6.0mg (95% CI: 4.5 to 7.5mg) and 12.6mg (95% CI: 7.9 to 17.2mg), respectively. The incidence of respiratory discomfort and maternal satisfaction scores did not differ significantly between dose groups. Phenylephrine dose and nausea/vomiting incidence increased with increasing doses of bupivacaine. Under study conditions, our results suggest that 12.6mg of intrathecal bupivacaine, administered with fentanyl and morphine, is required to achieve adequate intraoperative analgesia without the need for epidural supplemention. Copyright © 2017 Elsevier Ltd. All rights reserved.

[A prospective, randomized, double-blinded control study on comparison of tramadol, clonidine and dexmedetomidine for post spinal anesthesia shivering].

PubMed

Venkatraman, Rajagopalan; Karthik, Krishnamoorthy; Pushparani, Anand; Mahalakshmi, Annadurai

Shivering, a common intraoperative problem under spinal anesthesia increases the oxygen consumption considerably and is uncomfortable and distressing to the patient, anesthesiologist as well as surgeon. The present study was designed to explore the effectiveness of tramadol, clonidine and dexmedetomidine in the treatment of post spinal anesthesia shivering and to look for their adverse effects. This prospective, randomized, double blinded control study was done on 90 patients who developed shivering under spinal anesthesia. They were randomly allocated into three groups with Group T receiving tramadol 1mg.kg -1 , Group C getting clonidine 1mcg.kg -1 and Group D patients receiving dexmedetomidine 0.5mcg.kg -1 . The time taken to control shivering, recurrence rate, hemodynamic variables, sedation score and adverse effects were observed. Dexmedetomidine was faster in the control of shivering in 5.7±0.79minutes (min) whereas tramadol took 6.76±0.93min and clonidine was slower with 9.43±0.93min. The recurrence rate was much lower in the dexmedetomidine group with 3.3% than for clonidine (10%) and tramadol (23.3%) group. The sedation achieved with dexmedetomidine was better than clonidine and tramadol. The tramadol group had more cases of vomiting (four) and dexmedetomidine group had six cases of hypotension and two cases of bradycardia. Two of the clonidine patients encountered bradycardia and hypotension. Dexmedetomidine is better than tramadol and clonidine in the control of shivering because of its faster onset and less recurrence rate. Though complications are encountered in the dexmedetomidine group, they are treatable. Copyright © 2016 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

Postoperative Analgesic Efficacy of Bilateral Transversus Abdominis Plane Block in Patients Undergoing Midline Colorectal Surgeries Using Ropivacaine: A Randomized, Double-blind, Placebo-controlled Trial.

PubMed

Qazi, Nahida; Bhat, Wasim Mohammad; Iqbal, Malik Zaffar; Wani, Anisur Rehman; Gurcoo, Showkat A; Rasool, Sahir

2017-01-01

Ultrasound-guided transversus abdominis plane (TAP) block is done as a part of multimodal analgesia for pain relief after abdominal surgeries. This prospective randomized, double-blind, placebo-controlled trial was conducted to evaluate the postoperative analgesic efficacy of bilateral TAP block in patients undergoing midline colorectal surgeries using ropivacaine. Eighty patients scheduled for elective colorectal surgeries involving midline abdominal wall incision under general anesthesia were enrolled in this prospective randomized controlled trial. Group A received TAP block with 20 ml of 0.2% ropivacaine on either side of the abdominal wall, and Group B received 20 ml of normal saline. The time to request for rescue analgesia, total analgesic consumption in 24 h, and satisfaction with the anesthetic technique were assessed. The mean visual analog scale scores at rest and on coughing were higher in control group ( P > 0.05). Time (min) to request for the first rescue analgesia was prolonged in study group compared to control group ( P < 0.001). The total tramadol consumption in 24 h postoperatively was significantly high in control group ( P < 0.001). Nausea/vomiting was more common in control group ( P > 0.05). The level of satisfaction concerning postoperative pain control/anesthetic technique was higher in study group ( P < 0.001). TAP block produces effective and prolonged postoperative analgesia in patients undergoing midline colorectal surgery. It is a technically simple block to perform with a high margin of safety. It produces a considerable reduction in mean intravenous postoperative tramadol requirements, reduction in postoperative pain scores, and increased time to first request for further analgesia, both at rest and on movement.

Umbilical cord mesenchyme stem cell local intramuscular injection for treatment of uterine niche: Protocol for a prospective, randomized, double-blinded, placebo-controlled clinical trial.

PubMed

Fan, Dazhi; Wu, Shuzhen; Ye, Shaoxin; Wang, Wen; Guo, Xiaoling; Liu, Zhengping

2017-11-01

Uterine niche is defined as a triangular anechoic structure at the site of the scar or a gap in the myometrium at the site of a previous caesarean section. The main clinical manifestations are postmenstrual spotting and intrauterine infection, which may seriously affect the daily life of nonpregnant women. Trials have shown an excellent safety and efficacy for the potential of mesenchymal stem cells (MSCs) as a therapeutic option for scar reconstruction. Therefore, this study is designed to investigate the safety and efficacy of using MSCs in the treatment for the uterine niche. This phase II clinical trial is a single-center, prospective, randomized, double-blind, placebo-controlled with 2 arms. One hundred twenty primiparous participants will be randomly (1:1 ratio) assigned to receive direct intramuscular injection of MSCs (a dose of 1*10 cells in 1 mL of 0.9% saline) (MSCs group) or an identical-appearing 1 mL of 0.9% saline (placebo-controlled group) near the uterine incision. The primary outcome of this trial is to evaluate the proportion of participants at 6 months who is found uterine niche in the uterus by transvaginal utrasonography. Adverse events will be documented in a case report form. The study will be conducted at the Department of Obstetric of Southern Medical University Affiliated Maternal & Child Health Hospital of Foshan. This trial is the first investigation of the potential for therapeutic use of MSCs for the management of uterine niche after cesarean delivery. This protocol will help to determine the efficacy and safety of MSCs treatment in uterine niche and bridge the gap with regards to the current preclinical and clinical evidence. NCT02968459 (Clinical Trials.gov: http://clinicaltrials.gov/).

Efficacy of articaine versus lidocaine as a supplemental buccal infiltration in mandibular molars with irreversible pulpitis: a prospective, randomized, double-blind study.

PubMed

Rogers, Brandon S; Botero, Tatiana M; McDonald, Neville J; Gardner, Richard J; Peters, Mathilde C

2014-06-01

Profound pulpal anesthesia in mandibular molars with irreversible pulpitis (IP) is often difficult to obtain and often requires supplemental injections after an ineffective inferior alveolar nerve block (IANB). The purpose of this prospective, randomized, double-blind study was to compare the efficacy of 4% articaine with 2% lidocaine for supplemental buccal infiltrations (BIs) after an ineffective IANB in mandibular molars with IP. In addition, the use of articaine for IANB and intraosseous injections was investigated. One hundred emergency patients diagnosed with IP of a mandibular molar were selected and received an IANB with 4% articaine. All injections were 1.7 mL with 1:100,000 epinephrine. All patients reported profound lip numbness after IANB. Patients with ineffective IANB (positive pulpal response to cold or pain on access) randomly received 4% articaine or 2% lidocaine as a supplemental BI. Endodontic access was initiated 5 minutes after deposition of the infiltration solution. Success was defined as no pain or no more than mild pain during endodontic access and instrumentation as measured on a visual analogue scale. Seventy-four patients failed to achieve pulpal anesthesia after IANB with 4% articaine, resulting in IANB success rate of 26%. Success rates for supplemental BIs were 62% for articaine and 37% for lidocaine (P < .05). This effect was most pronounced in second molars (P < .05). Supplemental BI with articaine was significantly more effective than lidocaine. The IANB success rate of 4% articaine confirmed published data. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Comparing parecoxib and ketorolac as preemptive analgesia in patients undergoing posterior lumbar spinal fusion: a prospective randomized double-blinded placebo-controlled trial.

PubMed

Siribumrungwong, Koopong; Cheewakidakarn, Julin; Tangtrakulwanich, Boonsin; Nimmaanrat, Sasikaan

2015-03-18

Poor postoperative pain control is frequently associated with complications and delayed discharge from a hospital. Preemptive analgesia is one of the methods suggested for reducing postoperative pain. Opioids are effective for pain control, but there known addictive properties make physicians cautious about using them. Parecoxib and ketorolac are potent non-opioid NSAIDs that are attractive alternative drugs to opioids to avoid opioid-related side effects. However, there are no good head-to-head comparisons between these two drugs in the aspect of preemptive analgesic effects in lumbar spinal fusion surgery. This study aimed to compare the efficacy in terms of postoperative pain control and safety of parecoxib with ketorolac as preemptive analgesia in posterior lumbar spinal fusion patients. A prospective, double-blinded randomized controlled trial was carried out in patients undergoing posterior lumbar spinal fusion, who were randomized into 3 groups (n = 32). Parecoxib, ketorolac or a placebo was given to each patient via injection around 30 minutes prior to incision. The efficacy of postoperative pain control was assessed by a verbal numerical rating score (0-10). And various postoperative things were monitored for analysis, such as total opioid consumption, complications, and estimated blood loss. Both the ketorolac and parecoxib groups showed significantly better early postoperative pain reduction at the postanesthesia care unit (PACU) than the control group (p < 0.05). There were no differences between the pain scores of ketorolac and parecoxib at any time points. Complications and bleeding were not significantly different between all three groups. Preemptive analgesia using both ketorolac and parecoxib showed a significantly better early postoperative pain control in the PACU than the control group in patients undergoing lumbar spinal fusion. ClinicalTrials.gov NCT01859585. Registered 15 May 2013.

A prospective, randomized, double blind, placebo-controlled evaluation of the effects of eicosapentaenoic acid and docosahexaenoic acid on the clinical signs and erythrocyte membrane polyunsaturated fatty acid concentrations in dogs with osteoarthritis.

PubMed

Mehler, Stephen J; May, Lauren R; King, Crystal; Harris, William S; Shah, Zubin

2016-06-01

Osteoarthritis (OA) in dogs is a prevalent and serious condition. The most common treatment for the clinical signs of OA in dogs is the administration of nonsteroidal antiiflammatory pharmaceuticals. Omega-3 (n-3) fatty acids have been shown to reduce the clinical signs of osteoarthritis in dogs. The primary goals of this study were 1) to determine the effects of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on the clinical signs of OA in dogs, 2) to evaluate the effects of supplementation on the arachadonic acid (ARA)/ (EPA+DHA) algorithm and 3) to correlate alterations in the ARA/(EPA+DHA) with changes in the clinical signs of canine OA. Seventy-eight client owned dogs were enrolled in a prospective, randomized, double-blind, placebo controlled clinical trial. Dogs were randomized to placebo oil or triglyceride n-3 oil (providing an average dose of 69mg EPA+DHA/kg/day). Orthopedic examinations and blood analyses were performed at baseline, day 42, and day 84. A single investigator confirmed a diagnosis of OA of the coxofemoral joints and/or stifle joints in all dogs. Seventy-four dogs completed the trial. All clinical outcomes for measuring discomfort, lameness, and joint severity at day 84 and all blood metrics at day 42 and day 84 significantly (p<0.05) improved compared with placebo. No major side effects were observed. This study demonstrated that the daily supplementation of a dogs diet with EPA and DHA shifts the blood fatty acid concentrations correlating to relief of clinical signs associated with OA in dogs. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Efficacy of a Buffered 4% Lidocaine Formulation for Incision and Drainage: A Prospective, Randomized, Double-blind Study.

PubMed

Harreld, Taryn Kratz; Fowler, Sara; Drum, Melissa; Reader, Al; Nusstein, John; Beck, Mike

2015-10-01

Incision and drainage of symptomatic emergency patients with facial swelling is painful even after local anesthetics are administered. The purpose of this prospective, randomized, double-blind study was to compare the pain of infiltration and the pain of an incision and drainage procedure of a buffered versus a nonbuffered 4% lidocaine formulation in symptomatic emergency patients presenting with a diagnosis of pulpal necrosis, associated periapical area, and an acute clinical swelling. Eighty-eight emergency patients were randomly divided into 2 groups to receive 2 intraoral infiltration injections (mesial and distal to the swelling) of either 4% lidocaine with 1:100,000 epinephrine buffered with 0.18 mL 8.4% sodium bicarbonate using the Onpharma (Los Gatos, CA) buffering system or 4% lidocaine with 1:100,000 epinephrine. Subjects rated the pain of needle insertion, needle placement, and solution deposition for each injection using a 170-mm visual analog scale. An incision and drainage procedure was performed, and subjects rated the pain of incision, drainage, and dissection on a 170-mm visual analog scale. No significant differences between the buffered and nonbuffered 4% lidocaine formulations were found for needle insertion, placement, and solution deposition of the infiltration injections or for the treatment phases of incision, drainage, and dissection. Buffering a 4% lidocaine formulation did not significantly decrease the pain of infiltrations or significantly decrease the pain of the incision and drainage procedure when compared with a nonbuffered 4% lidocaine formulation in symptomatic patients with a diagnosis of pulpal necrosis and associated acute swelling. Copyright © 2015 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Postoperative Analgesic Efficacy of Bilateral Transversus Abdominis Plane Block in Patients Undergoing Midline Colorectal Surgeries Using Ropivacaine: A Randomized, Double-blind, Placebo-controlled Trial

PubMed Central

Qazi, Nahida; Bhat, Wasim Mohammad; Iqbal, Malik Zaffar; Wani, Anisur Rehman; Gurcoo, Showkat A.; Rasool, Sahir

2017-01-01

Background: Ultrasound-guided transversus abdominis plane (TAP) block is done as a part of multimodal analgesia for pain relief after abdominal surgeries. This prospective randomized, double-blind, placebo-controlled trial was conducted to evaluate the postoperative analgesic efficacy of bilateral TAP block in patients undergoing midline colorectal surgeries using ropivacaine. Materials and Methods: Eighty patients scheduled for elective colorectal surgeries involving midline abdominal wall incision under general anesthesia were enrolled in this prospective randomized controlled trial. Group A received TAP block with 20 ml of 0.2% ropivacaine on either side of the abdominal wall, and Group B received 20 ml of normal saline. The time to request for rescue analgesia, total analgesic consumption in 24 h, and satisfaction with the anesthetic technique were assessed. Results: The mean visual analog scale scores at rest and on coughing were higher in control group (P > 0.05). Time (min) to request for the first rescue analgesia was prolonged in study group compared to control group (P < 0.001). The total tramadol consumption in 24 h postoperatively was significantly high in control group (P < 0.001). Nausea/vomiting was more common in control group (P > 0.05). The level of satisfaction concerning postoperative pain control/anesthetic technique was higher in study group (P < 0.001). Conclusion: TAP block produces effective and prolonged postoperative analgesia in patients undergoing midline colorectal surgery. It is a technically simple block to perform with a high margin of safety. It produces a considerable reduction in mean intravenous postoperative tramadol requirements, reduction in postoperative pain scores, and increased time to first request for further analgesia, both at rest and on movement. PMID:28928585

C2 Nerve Field Stimulation for the Treatment of Fibromyalgia: A Prospective, Double-blind, Randomized, Controlled Cross-over Study.

PubMed

Plazier, Mark; Ost, Jan; Stassijns, Gaëtane; De Ridder, Dirk; Vanneste, Sven

2015-01-01

Fibromyalgia is a condition characterized by widespread chronic pain. Due to the high prevalence and high costs, it has a substantial burden on society. Treatment results are diverse and only help a small subset of patients. C2 nerve field stimulation, aka occipital nerve stimulation, is helpful and a minimally invasive treatment for primary headache syndromes. Small C2 pilot studies seem to be beneficial in fibromyalgia. Forty patients were implanted with a subcutaneous electrode in the C2 dermatoma as part of a prospective, double-blind, randomized, controlled cross-over study followed by an open label follow up period of 6 months. The patients underwent 2 week periods of different doses of stimulation consisting of minimal (.1 mA), subthreshold, and suprathreshold (for paresthesias) in a randomized order. Twenty seven patients received a permanent implant and 25 completed the 6 month open label follow up period. During the 6 week trial phase of the study, patients had an overall decrease of 36% on the fibromyalgia impact questionnaire (FIQ), a decrease of 33% fibromyalgia pain and improvement of 42% on the impact on daily life activities and quality. These results imply an overall improvement in the disease burden, maintained at 6 months follow up, as well as an improvement in life quality of 50%. Seventy six percent of patients were satisfied or very satisfied with their treatment. There seems to be a dose-response curve, with increasing amplitudes leading to better clinical outcomes. Subcutaneous C2 nerve field stimulation seems to offer a safe and effective treatment option for selected medically intractable patients with fibromyalgia. Copyright © 2015 Elsevier Inc. All rights reserved.

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.

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.

Quantitative evaluation of manufacturability and performance for ILT produced mask shapes using a single-objective function

NASA Astrophysics Data System (ADS)

Choi, Heon; Wang, Wei-long; Kallingal, Chidam

2015-03-01

The continuous scaling of semiconductor devices is quickly outpacing the resolution improvements of lithographic exposure tools and processes. This one-sided progression has pushed optical lithography to its limits, resulting in the use of well-known techniques such as Sub-Resolution Assist Features (SRAF's), Source-Mask Optimization (SMO), and double-patterning, to name a few. These techniques, belonging to a larger category of Resolution Enhancement Techniques (RET), have extended the resolution capabilities of optical lithography at the cost of increasing mask complexity, and therefore cost. One such technique, called Inverse Lithography Technique (ILT), has attracted much attention for its ability to produce the best possible theoretical mask design. ILT treats the mask design process as an inverse problem, where the known transformation from mask to wafer is carried out backwards using a rigorous mathematical approach. One practical problem in the application of ILT is the resulting contour-like mask shapes that must be "Manhattanized" (composed of straight edges and 90-deg corners) in order to produce a manufacturable mask. This conversion process inherently degrades the mask quality as it is a departure from the "optimal mask" represented by the continuously curved shapes produced by ILT. However, simpler masks composed of longer straight edges reduce the mask cost as it lowers the shot count and saves mask writing time during mask fabrication, resulting in a conflict between manufacturability and performance for ILT produced masks1,2. In this study, various commonly used metrics will be combined into an objective function to produce a single number to quantitatively measure a particular ILT solution's ability to balance mask manufacturability and RET performance. Several metrics that relate to mask manufacturing costs (i.e. mask vertex count, ILT computation runtime) are appropriately weighted against metrics that represent RET capability (i.e. process-variation band, edge-placement-error) in order to reflect the desired practical balance. This well-defined scoring system allows direct comparison of several masks with varying degrees of complexities. Using this method, ILT masks produced with increasing mask constraints will be compared, and it will be demonstrated that using the smallest minimum width for mask shapes does not always produce the optimal solution.

[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.

A randomized controlled trial of nitrous oxide for intrauterine device insertion in nulliparous women.

PubMed

Singh, Rameet H; Thaxton, Lauren; Carr, Shannon; Leeman, Lawrence; Schneider, Emily; Espey, Eve

2016-11-01

To evaluate the effectiveness of inhaled nitrous oxide for pain management among nulliparous women undergoing intrauterine device (IUD) insertion. A double-blind, randomized controlled trial was conducted among nulliparous women aged 13-45years who underwent IUD insertion at a US center between October 1, 2013, and August 31, 2014. Using a computer-generated randomization sequence, participants were randomly assigned to inhale either oxygen (O 2 ) or a mixture of 50% nitrous oxide and 50% oxygen (N 2 O/O 2 ) through a nasal mask for 2minutes before insertion. Only the person administering the inhalation agent was aware of group assignment. The primary outcome was maximum pain assessed 2minutes after insertion via a 100-mm visual analog scale. Analyses were by intention to treat. Forty women were assigned to each group. Mean maximum pain score at the time of insertion was 54.3±24.8mm for the N 2 O/O 2 group and 55.3±20.9mm for the O 2 group (P=0.86). Adverse effects were reported for 6 (15%) women in the N 2 O/O 2 group and 7 (18%) in the O 2 group (P=0.32). N 2 O/O 2 did not reduce the pain of IUD insertion among nulliparous women. ClinicalTrials.gov: NCT02391714. Published by Elsevier Ireland Ltd.

Integrating nutrition and early child-development interventions among infants and preschoolers in rural India.

PubMed

Fernandez-Rao, Sylvia; Hurley, Kristen M; Nair, Krishnapillai Madhavan; Balakrishna, Nagalla; Radhakrishna, Kankipati V; Ravinder, Punjal; Tilton, Nicholas; Harding, Kimberly B; Reinhart, Greg A; Black, Maureen M

2014-01-01

This article describes the development, design, and implementation of an integrated randomized double-masked placebo-controlled trial (Project Grow Smart) that examines how home/preschool fortification with multiple micronutrient powder (MNP) combined with an early child-development intervention affects child development, growth, and micronutrient status among infants and preschoolers in rural India. The 1-year trial has an infant phase (enrollment age: 6-12 months) and a preschool phase (enrollment age: 36-48 months). Infants are individually randomized into one of four groups: placebo, placebo plus early learning, MNP alone, and MNP plus early learning (integrated intervention), conducted through home visits. The preschool phase is a cluster-randomized trial conducted in Anganwadi centers (AWCs), government-run preschools sponsored by the Integrated Child Development System of India. AWCs are randomized into MNP or placebo, with the MNP or placebo mixed into the children's food. The evaluation examines whether the effects of the MNP intervention vary by the quality of the early learning opportunities and communication within the AWCs. Study outcomes include child development, growth, and micronutrient status. Lessons learned during the development, design, and implementation of the integrated trial can be used to guide large-scale policy and programs designed to promote the developmental, educational, and economic potential of children in developing countries. © 2013 New York Academy of Sciences.

Evaluation of the effects of botulinum toxin A injections when used to improve ease of care and comfort in children with cerebral palsy whom are non-ambulant: a double blind randomized controlled trial

PubMed Central

2012-01-01

Background Children with cerebral palsy (CP) whom are non-ambulant are at risk of reduced quality of life and poor health status. Severe spasticity leads to discomfort and pain. Carer burden for families is significant. This study aims to determine whether intramuscular injections of botulinum toxin A (BoNT-A) combined with a regime of standard therapy has a positive effect on care and comfort for children with CP whom are non-ambulant (GMFCS IV/V), compared with standard therapy alone (cycle I), and whether repeated injections with the same regime of adjunctive therapy results in greater benefits compared with a single injecting episode (cycle II). The regime of therapy will include serial casting, splinting and/or provision of orthoses, as indicated, combined with four sessions of goal directed occupational therapy or physiotherapy. Method/design This study is a double blind randomized controlled trial. Forty participants will be recruited. In cycle I, participants will be randomized to either a treatment group who will receive BoNT-A injections into selected upper and/or lower limb muscles, or a control group who will undergo sham injections. Both groups will receive occupational therapy and /or physiotherapy following injections. Groups will be assessed at baseline then compared at 4 and 16 weeks following injections or sham control. Parents, treating clinicians and assessors will be masked to group allocation. In cycle II, all participants will undergo intramuscular BoNT-A injections to selected upper and/or lower limb muscles, followed by therapy. The primary outcome measure will be change in parent ratings in identified areas of concern for their child’s care and comfort, using the Canadian Occupational Performance Measure (COPM). Secondary measures will include the Care and Comfort Hypertonicity Scale (ease of care), the Cerebral Palsy Quality of Life Questionnaire (CP QoL–Child) (quality of life), the Caregiver Priorities and Child Health Index of Life with Disabilities Questionnaire (CPCHILD©) (health status) and the Paediatric Pain Profile (PPP) (pain). Adverse events will be carefully monitored by a clinician masked to group allocation. Discussion This paper outlines the theoretical basis, study hypotheses and outcome measures for a trial of BoNT-A injections and therapy for children with non-ambulant CP. Trial registration Australia New Zealand Clinical Trials Registry:N12609000360213 PMID:22873758

A Randomized Double-Blind, Double-Dummy, Multicenter Trial of Azasetron versus Ondansetron to Evaluate Efficacy and Safety in the Prevention of Delayed Nausea and Vomiting Induced by Chemotherapy

PubMed Central

Lee, Hee Yeon; Lee, Kyung Hee; Kim, Bong-Seog; Song, Hong Suk; Yang, Sung Hyun; Kim, Joon Hee; Kim, Yeul Hong; Kim, Jong Gwang; Kim, Sang-We; Kim, Dong-Wan; Kim, Si-Young; Park, Hee Sook

2014-01-01

Purpose This study was conducted to evaluate the efficacy and safety of azasetron compared to ondansetron in the prevention of delayed chemotherapy-induced nausea and vomiting. Materials and Methods This study was a multi-center, prospective, randomized, double-dummy, double-blind and parallel-group trial involving 12 institutions in Korea between May 2005 and December 2005. A total of 265 patients with moderately and highly emetogenic chemotherapy were included and randomly assigned to either the azasetron or ondansetron group. All patients received azasetron (10 mg intravenously) and dexamethasone (20 mg intravenously) on day 1 and dexamethasone (4 mg orally every 12 hours) on days 2-4. The azasetron group received azasetron (10 mg orally) with placebo of ondansetron (orally every 12 hours), and the ondansetron group received ondansetron (8 mg orally every 12 hours) with placebo of azasetron (orally) on days 2-6. Results Over days 2-6, the effective ratio of complete response in the azasetron and ondansetron groups was 45% and 54.5%, respectively (95% confidence interval, -21.4 to 2.5%). Thus, the non-inferiority of azasetron compared with ondansetron in delayed chemotherapy-induced nausea and vomiting was not proven in the present study. All treatments were well tolerated and no unexpected drug-related adverse events were reported. The most common adverse events related to the treatment were constipation and hiccups, and there were no differences in the overall incidence of adverse events. Conclusion In the present study, azasetron showed inferiority in the control of delayed chemotherapy-induced nausea and vomiting compared with ondansetron whereas safety profiles were similar between the two groups. PMID:24520219

Optimal mask characterization by Surrogate Wafer Print (SWaP) method

NASA Astrophysics Data System (ADS)

Kimmel, Kurt R.; Hoellein, Ingo; Peters, Jan Hendrick; Ackmann, Paul; Connolly, Brid; West, Craig

2008-10-01

Traditionally, definition of mask specifications is done completely by the mask user, while characterization of the mask relative to the specifications is done completely by the mask maker. As the challenges of low-k1 imaging continue to grow in scope of designs and in absolute complexity, the inevitable partnership between wafer lithographers and mask makers has strengthened as well. This is reflected in the jointly owned mask facilities and device manufacturers' continued maintenance of fully captive mask shops which foster the closer mask-litho relationships. However, while some device manufacturers have leveraged this to optimize mask specifications before the mask is built and, therefore, improve mask yield and cost, the opportunity for post-fabrication partnering on mask characterization is more apparent and compelling. The Advanced Mask Technology Center (AMTC) has been investigating the concept of assessing how a mask images, rather than the mask's physical attributes, as a technically superior and lower-cost method to characterize a mask. The idea of printing a mask under its intended imaging conditions, then characterizing the imaged wafer as a surrogate for traditional mask inspections and measurements represents the ultimate method to characterize a mask's performance, which is most meaningful to the user. Surrogate wafer print (SWaP) is already done as part of leading-edge wafer fab mask qualification to validate defect and dimensional performance. In the past, the prospect of executing this concept has generally been summarily discarded as technically untenable and logistically intractable. The AMTC published a paper at BACUS 2007 successfully demonstrating the performance of SWaP for the characterization of defects as an alternative to traditional mask inspection [1]. It showed that this concept is not only feasible, but, in some cases, desirable. This paper expands on last year's work at AMTC to assess the full implementation of SWaP as an enhancement to mask characterization quality including defectivity, dimensional control, pattern fidelity, and in-plane distortion. We present a thorough analysis of both the technical and logistical challenges coupled with an objective view of the advantages and disadvantages from both the technical and financial perspectives. The analysis and model used by the AMTC will serve to provoke other mask shops to prepare their own analyses then consider this new paradigm for mask characterization and qualification.

Evaluating practical vs. theoretical inspection system capability with a new programmed defect test mask designed for 3X and 4X technology nodes

NASA Astrophysics Data System (ADS)

Glasser, Joshua; Pratt, Tim

2008-10-01

Programmed defect test masks serve the useful purpose of evaluating inspection system sensitivity and capability. It is widely recognized that when evaluating inspection system capability, it is important to understand the actual sensitivity of the inspection system in production; yet unfortunately we have observed that many test masks are a more accurate judge of theoretical sensitivity rather than real-world usable capability. Use of ineffective test masks leave the purchaser of inspection equipment open to the risks of over-estimating the capability of their inspection solution and overspecifying defect sensitivity to their customers. This can result in catastrophic yield loss for device makers. In this paper we examine some of the lithography-related technology advances which place an increasing burden on mask inspection complexity, such as MEEF, defect printability estimation, aggressive OPC, double patterning, and OPC jogs. We evaluate the key inspection system component contributors to successful mask inspection, including what can "go wrong" with these components. We designed and fabricated a test mask which both (a) more faithfully represents actual production use cases; and (b) stresses the key components of the inspection system. This mask's patterns represent 32nm, 36nm, and 45nm logic and memory technology including metal and poly like background patterns with programmed defects. This test mask takes into consideration requirements of advanced lithography, such as MEEF, defect printability, assist features, nearly-repetitive patterns, and data preparation. This mask uses patterns representative of 32nm, 36nm, and 45nm logic, flash, and DRAM technology. It is specifically designed to have metal and poly like background patterns with programmed defects. The mask is complex tritone and was designed for annular immersion lithography.

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

Single dose systemic acetaminophen to improve patient reported quality of recovery after ambulatory segmental mastectomy: A prospective, randomized, double-blinded, placebo controlled, clinical trial.

PubMed

De Oliveira, Gildasio S; Rodes, Meghan E; Bialek, Jane; Kendall, Mark C; McCarthy, Robert J

2017-11-15

Few systemic drug interventions are efficacious to improve patient reported quality of recovery after ambulatory surgery. We aimed to evaluate whether a single dose systemic acetaminophen improve quality of recovery in female patients undergoing ambulatory breast surgery. We hypothesized that patients receiving a single dose systemic acetaminophen at the end of the surgical procedure would have a better global quality of postsurgical recovery compared to the ones receiving saline. The study was a prospective randomized double blinded, placebo controlled, clinical trial. Healthy female subjects were randomized to receive 1 g single dose systemic acetaminophen at the end of the surgery or the same volume of saline. The primary outcome was the Quality of Recovery 40 (QOR-40) questionnaire at 24 hours after surgery. Other data collected included opioid consumption and pain scores. Data were analyzed using group t tests and the Wilcoxon exact test. The association between opioid consumption and quality of recovery was evaluated using Spearman rho. P < .05 was used to reject the null hypothesis for the primary outcome. Seventy subjects were randomized and sixty-five completed the study. Patients' baseline characteristics and surgical factors were similar between the study groups. There was a clinically significant difference in the global QoR-40 scores between the acetaminophen and the saline groups, median (IQR) of 189 (183 to 194) and 183 (175 to 190), respectively, P = .01. In addition, there was an inverse relationship (Spearman's rho= -0.33) between oral opioid consumption at home (oral morphine equivalents) and 24 hour postoperative quality of recovery, P = .007. A single dose of systemic acetaminophen improves patient reported quality of recovery after ambulatory breast surgery. The use of systemic acetaminophen is an efficacious strategy to improve patient perceived quality of postsurgical recovery and analgesic outcomes after hospital discharge for ambulatory breast surgery. © 2017 Wiley Periodicals, Inc.

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.

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

Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial.

PubMed

Hannemann, Pascal; Göttgens, Kevin W A; van Wely, Bob J; Kolkman, Karel A; Werre, Andries J; Poeze, Martijn; Brink, Peter R G

2011-05-06

The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%), non-union (5-21%) and early osteo-arthritis (up to 32%) which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences.Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning).Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory.Study parameters are clinical consolidation, radiological consolidation evaluated by CT-scanning, functional status of the wrist, including assessment by means of the patient rated wrist evaluation (PRWE) questionnaire and quality of life using SF-36 health survey questionnaire.Primary endpoint is number of scaphoid unions at six weeks, secondary endpoints are time interval to clinical and radiological consolidation, number of non-unions, functional status at 52 weeks and non-adherence to the treatment protocol. Netherlands Trial Register (NTR): NTR2064. © 2011 Hannemann et al; licensee BioMed Central Ltd.

Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial

PubMed Central

2011-01-01

Background The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%), non-union (5-21%) and early osteo-arthritis (up to 32%) which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences. Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. Methods/Design This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning). Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory. Study parameters are clinical consolidation, radiological consolidation evaluated by CT-scanning, functional status of the wrist, including assessment by means of the patient rated wrist evaluation (PRWE) questionnaire and quality of life using SF-36 health survey questionnaire. Primary endpoint is number of scaphoid unions at six weeks, secondary endpoints are time interval to clinical and radiological consolidation, number of non-unions, functional status at 52 weeks and non-adherence to the treatment protocol. Trial registration Netherlands Trial Register (NTR): NTR2064 PMID:21548951

Effect of sodium bicarbonate-buffered lidocaine on the success of inferior alveolar nerve block for teeth with symptomatic irreversible pulpitis: a prospective, randomized double-blind study.

PubMed

Saatchi, Masoud; Khademi, Abbasali; Baghaei, Badri; Noormohammadi, Hamid

2015-01-01

The purpose of this prospective, randomized, double-blind study was to compare the anesthetic efficacy of buffered with nonbuffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve (IAN) block in patients with mandibular posterior teeth experiencing symptomatic irreversible pulpitis. Eighty adult patients diagnosed with symptomatic irreversible pulpitis of a mandibular posterior tooth were selected. The patients received 2 cartridges of either 2% lidocaine with 1:80,000 epinephrine buffered with 0.18 mL 8.4% sodium bicarbonate or 2% lidocaine with 1:80,000 epinephrine with 0.18 mL sterile distilled water using conventional IAN block injections. Endodontic access preparation was initiated 15 minutes after injection. Lip numbness was required for all the patients. Success was determined as no or mild pain on the basis of Heft-Parker visual analog scale recordings upon access cavity preparation or initial instrumentation. Data were analyzed by the t, Mann-Whitney, and chi-square tests. The success rates were 62.5% and 47.5% for buffered and nonbuffered groups, respectively, with no significant differences between the two groups (P = .381). Buffering the 2% lidocaine with 1:80,000 epinephrine with 8.4% sodium bicarbonate did not improve the success of the IAN block in mandibular molars in patients with symptomatic irreversible pulpitis. Copyright © 2015 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Anesthetic Efficacy of Articaine and Ketamine for Inferior Alveolar Nerve Block in Symptomatic Irreversible Pulpitis: A Prospective Randomized Double-Blind Study

PubMed Central

Sakhaeimanesh, Vahid; Khazaei, Saber; Kaviani, Naser; Saatchi, Masoud; Shafiei, Maryam; Khademi, Abbasali

2017-01-01

Introduction: The aim of this prospective, randomized, double-blind study was to investigate the effect of articaine combined with ketamine on the success rate of inferior alveolar nerve block (IANB) in posterior mandible teeth with symptomatic irreversible pulpitis. Methods and Materials: Forty two adult patients with diagnosis of symptomatic irreversible pulpitis of a mandibular posterior tooth were selected. The patients received two cartridges of either containing 3.2 mL 4% articaine with epinephrine 1:200000 and 0.4 mL 50 mg/mL ketamine hydrochloride (A-ketamine group) or 3.2 mL 4% articaine with epinephrine 1:200000 and 0.4 mL normal saline (A-saline group) using conventional IANB injections. Access cavity preparation started 15 min after injection. Lip numbness was required for all the patients. Success was considered as no or mild pain on the basis of Heft-Parker visual analog scale recordings upon access cavity preparation or initial instrumentation. Data were analyzed by independent student t, Mann-Whitney and Chi-square tests. Results: The success rates were 55% and 42.9% for A-ketamine and A-saline group, respectively, with no significant differences between the two groups (P=0.437). Conclusion: Adding 0.4 mL 50 mg/mL ketamine hydrochloride to the articaine local anesthetic did not increase the efficacy of IANB for posterior mandibular teeth with symptomatic irreversible pulpitis. PMID:29225640

Double-blind prospective randomized study comparing polyethylene glycol to lactulose for bowel preparation in colonoscopy.

PubMed

Menacho, Aline Moraes; Reimann, Adriano; Hirata, Lie Mara; Ganzerella, Caroline; Ivano, Flavio Heuta; Sugisawa, Ricardo

2014-01-01

Colonoscopy is the most frequent exam used to evaluate colonic mucosa, allowing the diagnosis and treatment of many diseases. The appropriate bowel preparation is indispensable for the realization of colonoscopy. Therefore, it is necessary the use of laxative medications, preferentially by oral administration. To compare two medications used in bowel preparation in adult patients going to ambulatory colonoscopy and to analyze the patients' profile. A double-blind prospective study with 200 patients, randomized in two groups: one that received polyethilene glycol and another that received lactulose. The patients answered to questionnaires to data compilation, as tolerance, symptoms and complications related to preparation. Besides, it was also evaluated the prepare efficacy related to the presence of fecal residue. Intestinal habit alterations and abdominal pain were the main reasons to realize the exams and hypertension was the most prevalent comorbidity. Ten percent of the ones who received lactulose didn't get to finish the preparation and 50% considered the taste "bad, but tolerable". The most common subjective symptom after the medication was nausea, especially after lactulose. During the exam, most of the patients who used lactulose had a "light discomfort" and the ones who used polyethilene glycol considered the discomfort as "tolerable". The quality of the preparation was good in 75%, undependable of the medication that was used. Polyethilene glycol was more tolerable when compared to lactulose, without difference on the quality of the preparation.

DOUBLE-BLIND PROSPECTIVE RANDOMIZED STUDY COMPARING POLYETHYLENE GLYCOL TO LACTULOSE FOR BOWEL PREPARATION IN COLONOSCOPY

PubMed Central

MENACHO, Aline Moraes; REIMANN, Adriano; HIRATA, Lie Mara; GANZERELLA, Caroline; IVANO, Flavio Heuta; SUGISAWA, Ricardo

2014-01-01

Background Colonoscopy is the most frequent exam used to evaluate colonic mucosa, allowing the diagnosis and treatment of many diseases. The appropriate bowel preparation is indispensable for the realization of colonoscopy. Therefore, it is necessary the use of laxative medications, preferentially by oral administration. Aim To compare two medications used in bowel preparation in adult patients going to ambulatory colonoscopy and to analyze the patients' profile. Methods A double-blind prospective study with 200 patients, randomized in two groups: one that received polyethilene glycol and another that received lactulose. The patients answered to questionnaires to data compilation, as tolerance, symptoms and complications related to preparation. Besides, it was also evaluated the prepare efficacy related to the presence of fecal residue. Results Intestinal habit alterations and abdominal pain were the main reasons to realize the exams and hypertension was the most prevalent comorbidity. Ten percent of the ones who received lactulose didn't get to finish the preparation and 50% considered the taste "bad, but tolerable". The most common subjective symptom after the medication was nausea, especially after lactulose. During the exam, most of the patients who used lactulose had a "light discomfort" and the ones who used polyethilene glycol considered the discomfort as "tolerable". The quality of the preparation was good in 75%, undependable of the medication that was used. Conclusion Polyethilene glycol was more tolerable when compared to lactulose, without difference on the quality of the preparation. PMID:24676290

Short-term effects of highly-bioavailable curcumin for treating knee osteoarthritis: a randomized, double-blind, placebo-controlled prospective study.

PubMed

Nakagawa, Yasuaki; Mukai, Shogo; Yamada, Shigeru; Matsuoka, Masayuki; Tarumi, Eri; Hashimoto, Tadashi; Tamura, Chieko; Imaizumi, Atsushi; Nishihira, Jun; Nakamura, Takashi

2014-11-01

We previously developed a surface-controlled water-dispersible form of curcumin and named it Theracurmin(®) (Theracurmin; Theravalues, Tokyo, Japan). The area under the blood concentration-time curve of Theracurmin in humans was 27-fold higher than that of curcumin powder. We determined the clinical effects of orally administered Theracurmin in patients with knee osteoarthritis during 8 weeks of treatment. Fifty patients with knee osteoarthritis of Kellgren-Lawrence grade II or III and who were aged more than 40 years were enrolled in this randomized, double-blind, placebo-controlled, prospective clinical study. Placebo or Theracurmin containing 180 mg/day of curcumin was administered orally every day for 8 weeks. To monitor adverse events, blood biochemistry analyses were performed before and after 8 weeks of each intervention. The patients' knee symptoms were evaluated at 0, 2, 4, 6, and 8 weeks by the Japanese Knee Osteoarthritis Measure, the knee pain visual analog scale (VAS), the knee scoring system of the Japanese Orthopedic Association, and the need for nonsteroidal anti-inflammatory drugs. At 8 weeks after treatment initiation, knee pain VAS scores were significantly lower in the Theracurmin group than in the placebo group, except in the patients with initial VAS scores of 0.15 or less. Theracurmin lowered the celecoxib dependence significantly more than placebo. No major side effects were observed with Theracurmin treatment. Theracurmin shows modest potential for the treatment of human knee osteoarthritis.

Conformable covered versus uncovered self-expandable metallic stents for palliation of malignant gastroduodenal obstruction: a randomized prospective study.

PubMed

Lim, Sun Gyo; Kim, Jin Hong; Lee, Kee Myung; Shin, Sung Jae; Kim, Chan Gyoo; Kim, Kyung Ho; Kim, Ho Gak; Yang, Chang Heon

2014-07-01

A conformable self-expandable metallic stent was developed to overcome the limitation of previous self-expandable metallic stents. The aim of this study was to evaluate outcomes after placement of conformable covered and uncovered self-expandable metallic stents for palliation of malignant gastroduodenal obstruction. A single-blind, randomized, parallel-group, prospective study were conducted in 4 medical centres between March 2009 and July 2012. 134 patients with unresectable malignant gastroduodenal obstruction were assigned to a covered double-layered (n=66) or uncovered unfixed-cell braided (n=68) stent placement group. Primary analysis was performed to compare re-intervention rates between two groups. 120 patients were analysed (59 in the covered group and 61 in the uncovered group). Overall rates of re-intervention were not significantly different between the two groups: 13/59 (22.0%) in the covered group vs. 13/61 (21.3%) in the uncovered group, p=0.999. Stent migration was more frequent in the covered group than in the uncovered group (p=0.003). The tumour ingrowth rate was higher in the uncovered group than in the covered group (p=0.016). The rates of re-intervention did not significantly differ between the two stents. Conformable covered double-layered and uncovered unfixed-cell braided stents were associated with different patterns of stent malfunction. Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating Meniscal Healing, Clinical Outcomes, and Safety in Patients Undergoing Meniscal Repair of Unstable, Complete Vertical Meniscal Tears (Bucket Handle) Augmented with Platelet-Rich Plasma.

PubMed

Kaminski, Rafal; Kulinski, Krzysztof; Kozar-Kaminska, Katarzyna; Wielgus, Monika; Langner, Maciej; Wasko, Marcin K; Kowalczewski, Jacek; Pomianowski, Stanislaw

2018-01-01

The present study aimed to investigate the effectiveness and safety of platelet-rich plasma (PRP) application in arthroscopic repair of complete vertical tear of meniscus located in the red-white zone. This single center, prospective, randomized, double-blind, placebo-controlled, parallel-arm study included 37 patients with complete vertical meniscus tears. Patients received an intrarepair site injection of either PRP or sterile 0.9% saline during an index arthroscopy. The primary endpoint was the rate of meniscus healing in the two groups. The secondary endpoints were changes in the International Knee Documentation Committee (IKDC) score, Knee Injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and analog scale (VAS) in the two groups at 42 months. After 18 weeks, the meniscus healing rate was significantly higher in the PRP-treated group than in the control group (85% versus 47%, P = 0.048). Functional outcomes were significantly better 42 months after treatment than at baseline in both groups. The IKDC score, WOMAC, and KOOS were significantly better in the PRP-treated group than in the control group. No adverse events were reported during the study period. The findings of this study indicate that PRP augmentation in meniscus repair results in improvements in both meniscus healing and functional outcome.

A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating Meniscal Healing, Clinical Outcomes, and Safety in Patients Undergoing Meniscal Repair of Unstable, Complete Vertical Meniscal Tears (Bucket Handle) Augmented with Platelet-Rich Plasma

PubMed Central

Kulinski, Krzysztof; Kozar-Kaminska, Katarzyna; Wielgus, Monika; Langner, Maciej; Wasko, Marcin K.; Kowalczewski, Jacek; Pomianowski, Stanislaw

2018-01-01

Objective The present study aimed to investigate the effectiveness and safety of platelet-rich plasma (PRP) application in arthroscopic repair of complete vertical tear of meniscus located in the red-white zone. Methods This single center, prospective, randomized, double-blind, placebo-controlled, parallel-arm study included 37 patients with complete vertical meniscus tears. Patients received an intrarepair site injection of either PRP or sterile 0.9% saline during an index arthroscopy. The primary endpoint was the rate of meniscus healing in the two groups. The secondary endpoints were changes in the International Knee Documentation Committee (IKDC) score, Knee Injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and analog scale (VAS) in the two groups at 42 months. Results After 18 weeks, the meniscus healing rate was significantly higher in the PRP-treated group than in the control group (85% versus 47%, P = 0.048). Functional outcomes were significantly better 42 months after treatment than at baseline in both groups. The IKDC score, WOMAC, and KOOS were significantly better in the PRP-treated group than in the control group. No adverse events were reported during the study period. Conclusions The findings of this study indicate that PRP augmentation in meniscus repair results in improvements in both meniscus healing and functional outcome. PMID:29713647

A Prospective Randomized Clinical Trial of Single vs. Double Layer Closure of Hysterotomy at the Time of Cesarean Delivery: The Effect on Uterine Scar Thickness.

PubMed

Bamberg, Christian; Dudenhausen, Joachim W; Bujak, Verena; Rodekamp, Elke; Brauer, Martin; Hinkson, Larry; Kalache, Karim; Henrich, Wolfgang

2018-06-01

 We undertook a randomized clinical trial to examine the outcome of a single vs. a double layer uterine closure using ultrasound to assess uterine scar thickness.  Participating women were allocated to one of three uterotomy suture techniques: continuous single layer unlocked suturing, continuous locked single layer suturing, or double layer suturing. Transvaginal ultrasound of uterine scar thickness was performed 6 weeks and 6 - 24 months after Cesarean delivery. Sonographers were blinded to the closure technique.  An "intent-to-treat" and "as treated" ANOVA analysis included 435 patients (n = 149 single layer unlocked suturing, n = 157 single layer locked suturing, and n = 129 double layer suturing). 6 weeks postpartum, the median scar thickness did not differ among the three groups: 10.0 (8.5 - 12.3 mm) single layer unlocked vs. 10.1 (8.2 - 12.7 mm) single layer locked vs. 10.8 (8.1 - 12.8 mm) double layer; (p = 0.84). At the time of the second follow-up, the uterine scar was not significantly (p = 0.06) thicker if the uterus had been closed with a double layer closure 7.3 (5.7 - 9.1 mm), compared to single layer unlocked 6.4 (5.0 - 8.8 mm) or locked suturing techniques 6.8 (5.2 - 8.7 mm). Women who underwent primary or elective Cesarean delivery showed a significantly (p = 0.03, p = 0.02, "as treated") increased median scar thickness after double layer closure vs. single layer unlocked suture.  A double layer closure of the hysterotomy is associated with a thicker myometrium scar only in primary or elective Cesarean delivery patients. © Georg Thieme Verlag KG Stuttgart · New York.

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/

Multiple beam mask writers: an industry solution to the write time crisis

NASA Astrophysics Data System (ADS)

Litt, Lloyd C.

2010-09-01

The semiconductor industry is under constant pressure to reduce production costs even as technology complexity increases. Lithography represents the most expensive process due to its high capital equipment costs and the implementation of low-k1 lithographic processes, which has added to the complexity of making masks through the greater use of optical proximity correction, pixelated masks, and double or triple patterning. Each of these mask technologies allows the production of semiconductors at future nodes while extending the utility of current immersion tools. Low k1 patterning complexity combined with increased data due to smaller feature sizes is driving extremely long mask write times. While a majority of the industry is willing to accept mask write times of up to 24 hours, evidence suggests that the write times for many masks at the 22 nm node and beyond will be significantly longer. It has been estimated that $50M+ in non-recurring engineering (NRE) costs will be required to develop a multiple beam mask writer system, yet the business case to recover this kind of investment is not strong. Moreover, funding such a development is a high risk for an individual supplier. The problem is compounded by a disconnect between the tool customer (the mask supplier) and the final mask customer that will bear the increased costs if a high speed writer is not available. Since no individual company will likely risk entering this market, some type of industry-wide funding model will be needed. Because SEMATECH's member companies strongly support a multiple beam technology for mask writers to reduce the write time and cost of 193 nm and EUV masks, SEMATECH plans to pursue an advanced mask writer program in 2011 and 2012. In 2010, efforts will focus on identifying a funding model to address the investment to develop such a technology.

[Clinical study of the effectiveness of a dexpanthenol containing artificial tears solution (Siccaprotect) in treatment of dry eyes].

PubMed

Göbbels, M; Gross, D

1996-01-01

In this controlled, randomized, double-masked study the effect of dexpanthenol-containing artificial tears (Siccaprotect) on patients with dry eyes was examined. 50 patients applied either dexpanthenol-containing artificial tears (Siccaprotect) or the identical, but free of dexpanthenol, eye drops five times daily into the conjunctival sac. No other ophthalmics were administered. The corneal epithelial permeability was measured by fluorophotometry and Schirmer-Test, Rose Bengal staining, tear film break-up time and the patients' subjective complaints were determined before and after 6 weeks of treatment. The dexpanthenol-containing artificial tears (Siccaprotect) improved disturbances of the corneal epithelial permeability significantly in comparison to the dexpanthenol-free eyes drops. The other parameters didn't show relevant differences. These data suggest that, in dry eyes, treatment with dexpanthenol-containing eye drops leads to a favorable and comparing with dexpanthenol-free eye drops superior improvement in disturbances of corneal epithelium permeability.

Community-based recruitment strategies for a longitudinal interventional study: the VECAT experience.

PubMed

Garrett, S K; Thomas, A P; Cicuttini, F; Silagy, C; Taylor, H R; McNeil, J J

2000-05-01

This article examines different recruitment strategies for the VECAT Study, a 4-year, double-masked, placebo-controlled, randomized clinical trial of vitamin E in the prevention of cataract and age-related maculopathy. Five recruitment methods were employed: newspaper advertising, radio advertising, approaches to community groups, approaches via general practices, and an electoral roll mail-out. Participants (1204) from the community in Melbourne, Australia were recruited and enrolled within 15 months (age range: 55-80 years, mean 66 years; gender ratio: 57% female, 43% male). The electoral roll mail-out and newspaper advertising were the most efficient methods of recruitment in terms of absolute numbers of participants recruited and cost per participant. Recruitment for the VECAT study was successfully completed within the planned period. Although the electoral roll mail-out and newspaper advertising were the most efficient for this study, other methods may be of value for studies with different subject selection criteria.

Brimonidine 0.2% vs unoprostone 0.15% both added to timolol maleate 0.5% given twice daily to patients with primary open-angle glaucoma or ocular hypertension.

PubMed

Sharpe, E D; Henry, C J; Mundorf, T K; Day, D G; Stewart, J A; Jenkins, J N; Stewart, W C

2005-01-01

To compare the efficacy and safety of brimonidine 0.2% vs unoprostone 0.15%, both added to timolol maleate 0.5% each given twice daily. In this prospective, multi-centred, double-masked, crossover comparison, patients were randomized to one treatment group for a 6-week treatment period, and then crossed over to the opposite treatment. Measurements were performed at 0800, 1000, 1600, 1800, and 2000 h at baseline and at the end of each treatment period. In all, 33 patients entered this trial and 29 completed. The baseline trough intraocular pressure (IOP) was 23.3+/-2.4 and the diurnal curve IOP was 22.0+/-1.3 mmHg. For the brimonidine and timolol maleate treatment group, the trough IOP was 21.6+/-3.3 and the diurnal curve IOP was 19.8+/-2.1 mmHg, while the timolol and unoprostone treatment showed a trough IOP of 20.9+/-3.8 and a diurnal curve IOP of 19.3+/-2.4 mmHg. There was no significant difference between treatment groups at any time point for the diurnal curve, or in the reduction from baseline (P>0.05). Both treatments failed to statistically reduce the IOP from baseline at 1800 h. There was no difference between treatment groups regarding ocular and systemic unsolicited adverse events, but patients admitted to more dryness (P=0.02) and burning upon instillation (P<0.0001) with unoprostone by survey. Brimonidine 0.2% or unoprostone 0.15% added to timolol maleate 0.5% provide similar efficacy and safety throughout the daytime diurnal curve.

Biocompatibility of antimicrobial melimine lenses: rabbit and human studies.

PubMed

Dutta, Debarun; Ozkan, Jerome; Willcox, Mark D P

2014-05-01

Covalent immobilization of antimicrobial peptide melimine onto contact lenses can produce broad-spectrum antimicrobial lenses. The purpose of this study was to investigate the performance of melimine-coated contact lenses in an animal model and human clinical trial. Melimine was covalently attached onto the surface of contact lenses via EDC (1-ethyl-3-[3-dimethylaminopropyl] carbodiimide hydrochloride) coupling. A rabbit model of daily contralateral wear of lenses for 22 days was conducted to assess the lens safety. A prospective, randomized, double-masked, one-day human clinical trial was used to evaluate subjective responses and ocular physiology during contralateral wear of melimine-coated (test) and uncoated (control) lenses. Delayed reactions were monitored during follow-up visits after 1 and 4 weeks. Ex vivo retention of antimicrobial activity of worn lenses was assessed by reduction in numbers of viable Pseudomonas aeruginosa and Staphylococcus aureus. Melimine-coated lenses produced no ocular signs or symptoms that would indicate cytotoxicity during the lens wear of rabbits. No histological changes were found in rabbit corneas. During the human trial, no differences were observed in wettability, surface deposition, lens-fitting centration, movement, tightness, and corneal coverage between test and control lenses (p > 0.05). There were no significant differences in bulbar, limbal, or palpebral redness or conjunctival staining (p > 0.05). Mean corneal (extent, depth, and type) staining was higher for test lenses compared with that for control lenses (p < 0.05). There was no significant difference in subjective responses for lens comfort, dryness, and awareness (p > 0.05). No delayed reactions were associated with the test lenses. Worn test lenses retained more than 1.5 log inhibition against both bacterial types. Melimine-coated contact lenses were worn safely by humans. However, they were associated with higher corneal staining. The melimine-coated lenses retained high antibacterial activity after wear.

Safety and efficacy of 0.1% clobetasone butyrate eyedrops in the treatment of dry eye in Sjögren syndrome.

PubMed

Aragona, Pasquale; Spinella, Rosaria; Rania, Laura; Postorino, Elisa; Sommario, Margherita S; Roszkowska, Anna M; Puzzolo, Domenico

2013-01-01

To study the effects of a low administration rate and low concentration (0.1%) of clobetasone butyrate eyedrops in patients with Sjögren syndrome (SS).
 This prospective, double-masked, randomized, placebo-controlled study included 40 subjects divided into 2 treatment groups: group 1 (2% polyvinylpyrrolidone eyedrops and placebo) and group 2 (2% polyvinylpyrrolidone and 0.1% clobetasone butyrate, 1 drop BID). The treatment lasted for 30 days, with visits at enrollment, baseline, day 15, day 30, and after 15 days of treatment discontinuation. At each visit, symptoms questionnaire, tear film break-up time, corneal fluorescein stain, lissamine green stain, conjunctival impression cytology for human leukocyte antigen-DR (HLA-DR) expression, intraocular pressure (IOP) measurement, and fundus examination were performed. 
 No changes in IOP or fundus examination were observed in either group at each time point. Group 1 patients showed at day 30 a statistically significant amelioration of symptoms and reduction of HLA-DR expression. No changes in other parameters were detected. Group 2 patients showed at day 15 a statistically significant improvement of corneal and conjunctival stain versus baseline values and group 1 at the same time; after 30 days the symptoms score was statistically significantly better than baseline values and group 1 at the same time. The HLA-DR expression and the epithelial cells area were statistically significantly reduced versus baseline and group 1 at the same time. 
 Anti-inflammatory therapy is critical for the treatment of SS dry eye. Clobetasone butyrate, at low dosage, proved to be safe and effective in treating this condition.

AcrySof Natural SN60AT versus AcrySof SA60AT intraocular lens in patients with color vision defects.

PubMed

Raj, Shetal M; Vasavada, Abhay R; Nanavaty, Mayank A

2005-12-01

To determine whether implantation of the AcrySof Natural intraocular lens (IOL) worsened the severity of existing color deficit in congenital partial red-green color deficient individuals (CPRG). A prospective controlled randomized double-masked analysis of 30 consecutive patients with CPRG defect and bilateral cataracts received a Natural IOL (test group) in 1 eye and a single-piece AcrySof IOL (control group) in the other eye. Patients were tested unilaterally to detect CPRG defect using Ishihara pseudoisochromatic plates and the Farnsworth D-15 test. Plates 1 to 21 measured the Ishihara error score; plates 22 to 25 indicated severity of defect based on clarity of both numerals as partial mild/moderate (both visible), partial severe defect (only 1 visible). The D-15 test is based on number of diametrical crossings on the circular diagram; severity is graded as mild (1 crossing), moderate (2 crossings), or severe (>2 crossings). Tests were performed before and after IOL implantation at 1, 3, and 6 months. At mean follow-up of 6.13 months +/- 1.2 (SD), analysis of variance test judged the difference in error scores and cross tabulation represented change in number of diametrical crossings. The mean age was 62.3 +/- 8.5 years. All patients were men. Before IOL implantation, all patients had moderate CPRG defect on both tests. The Ishihara error score in the test and control groups did not reveal statistically significant differences (P = .505 and P = .119, respectively). With D-15, none of the patients in the test or control group showed >2 crossings. The implantation of AcrySof Natural IOL did not worsen the preexisting severity of color defect in CPRG individuals.

Safety, tolerability, and bioavailability of topical SAR 1118, a novel antagonist of lymphocyte function-associated antigen-1: a phase 1b study.

PubMed

Paskowitz, D M; Nguyen, Q D; Gehlbach, P; Handa, J T; Solomon, S; Stark, W; Shaikh, O; Semba, C; Gadek, T R; Do, D V

2012-07-01

A growing body of evidence points to a role for inflammation mediated by lymphocyte function-associated antigen-1 (LFA-1) and its ligand intercellular adhesion molecule-1 in the pathogenesis of diabetic macular oedema. This phase 1b clinical trial assessed the safety, tolerability, and pharmacokinetics of topically administered SAR 1118, a novel LFA-1 antagonist, in human subjects. In this prospective, randomized, double-masked trial, 13 subjects scheduled for vitrectomy received one of three concentrations of topical SAR 1118 (0.1, 1.0, or 5.0%) twice daily for 1 week before surgery. Undiluted aqueous and vitreous samples were collected at surgery and analysed for the concentration of the medication. All subjects completed the entire course of medication. The only adverse events reported were instillation site irritation (4/13, 31%) and dysgeusia (3/13, 23%). These were mild and transient, occurring at the highest dose. Mean concentrations (ng/ml) of SAR 1118 in the aqueous humour were 0.25, 37.2, and 101.1 for the 0.1%, 1.0%, and 5.0% dose groups, respectively. SAR 1118 was below the level of detection (0.5 ng/ml) for all vitreous samples except in a single subject who had a history of prior vitrectomy and a dislocated intraocular lens. Topical SAR 1118 was safe and well tolerated, and dose-dependent levels of drug were detected in aqueous. However, vitreous levels were below the threshold of detection with the concentrations tested. Further investigation of this medication for posterior segment applications would require intravitreal delivery or chemical modification of the drug.

Evaluation of safety and efficacy of a new multipurpose disinfecting solution on silicone hydrogel contact lenses.

PubMed

Pinto-Fraga, José; Blázquez Arauzo, Francisco; Urbano Rodríguez, Rubén; González-García, María J

2015-01-01

To evaluate the safety and efficacy of a new multipurpose disinfecting solution (MPDS) with a formulation that includes aloe vera on its composition. This is a prospective, randomized, double-masked clinical trial with a crossover design that included seven examinations. Two different MPDSs, Avizor Alvera® (study solution) and All Clean Soft® (control solution), each were used for 1 month. Comfilcon A silicone hydrogel contact lenses were used during the trial. The main outcome variables were corneal staining and deposits on the surfaces of the contact lenses. Other parameters including ocular surface response, contact lens wettability, user satisfaction, and adverse events, were analyzed according to the International Organization for Standardization (ISO) 11980:2010 guidance for clinical investigation. Twenty subjects (10 women, 10 men) (mean age, 27.7±5.6 years; range, 20-41) were included. No differences between both MPDSs were found in the percentage of subjects with corneal staining >0 at day 30 (study: 35%, control: 50%; p=0.46); neither in the percentage of subjects with deposits on the surface of the contact lens >0 at day 30 (study: 26.32%, control: 52.63%; p=0.18). The study MPDS received higher rates in comfort (study: 8.14±1.09, control: 7.94±0.92; p=0.56) and satisfaction at day 30 (study: 8.63±0.91, control: 8.29±0.80; p=0.19), however the scores were not significantly different with the control MPDS. The clinical trial showed that the study MPDS is safe, efficient, and has acceptable physiologic tolerance, according to the ISO 11980:2010 guidance for clinical investigation. Copyright © 2014 Spanish General Council of Optometry. Published by Elsevier Espana. All rights reserved.

Quartz 9-inch size mask blanks for ArF PSM (Phase Shift Mask)

NASA Astrophysics Data System (ADS)

Harashima, Noriyuki; Isozaki, Tatsuya; Kawanishi, Arata; Kanai, Shuichiro; Kageyama, Kagehiro; Iso, Hiroyuki; Chishima, Tatsuya

2017-07-01

Semiconductor technology nodes are steadily miniaturizing. On the other hand, various efforts have been made to reduce costs, mass production lines have shifted from 200 mmφ of Si wafer to 300 mmφ, and technology development of Si wafer 450 mmφ is also in progress. As a photomask, 6-inch size binary Cr mask has been used for many years, but in recent years, the use of 9-inch binary Cr masks for Proximity Lithography Process in automotive applications, MEMS, packages, etc. has increased, and cost reduction has been taken. Since the miniaturization will progress in the above applications in the future, products corresponding to miniaturization are also desired in 9-inch photomasks. The high grade Cr - binary mask blanks used in proximity exposure process, there is a prospect of being able to use it by ULVAC COATING CORPORATION's tireless research. As further demands for miniaturization, KrF and ArF Lithography Process, which are used for steppers and scanners , there are also a demand for 9-inch size Mask Blanks. In ULVAC COATING CORPORATION, we developed a 9 - inch size KrF PSM mask Blanks prototype in 2016 and proposed a new high grade 9 - inch photomask. This time, we have further investigated and developed 9-inch size ArF PSM Mask Blanks corresponding to ArF Lithography Process, so we report it.

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.

Efficacy of fluoride varnish for preventing white spot lesions and gingivitis during orthodontic treatment with fixed appliances-a prospective randomized controlled trial.

PubMed

Kirschneck, Christian; Christl, Jan-Joachim; Reicheneder, Claudia; Proff, Peter

2016-12-01

The development of white spot lesions around orthodontic brackets and gingivitis is a common problem during orthodontic treatment with fixed appliances. This prospective randomized double-blind controlled clinical trial investigated the preventive efficacy of a one-time application of two commonly used fluoride varnishes in patients with low to moderate caries risk. Ninety adolescent orthodontic patients with a low to moderate caries risk were prospectively randomized to three groups of 30 patients each: (1) standardized dental hygiene with fluoride toothpaste and one-time application of placebo varnish (control) or (2) of elmex® fluid or (3) of Fluor Protector S on all dental surfaces at the start of fixed therapy. The extent of enamel demineralization and gingivitis was determined with the ICDAS and the gingivitis index (GI) at baseline and after 4, 12, and 20 weeks. Each treatment group showed a significant increase of the ICDAS index, but not of the GI over the course of time with no significant intergroup differences detectable. A one-time application of fluoride varnish at the start of orthodontic treatment did not provide any additional preventive advantage over sufficient dental hygiene with fluoride toothpaste with regard to formation of white spots and gingivitis in patients with a low to moderate caries risk. In dental practice, patients often receive an application of fluoride varnish at the start of orthodontic treatment with fixed appliances. However, the efficacy of this procedure is still unclear.

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;

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.

Numerical Generation of Double Star Images for Different Types of Telescopes

NASA Astrophysics Data System (ADS)

Xavier, Ademir

2015-11-01

This paper reviews the modeling of stellar images using diffraction theory applied to different types of telescope masks. The masks are projected by secondary mirror holder vanes (such as the spider type) or holes on the primary mirror which result in different configurations of single stellar images. Using Fast Fourier Transform, the image of binary stars with different magnitudes is calculated. Given the numerical results obtained, a discussion is presented on the best secondary vane configurations and on the effect of obstruction types for the separation of binary pairs with different magnitudes.

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.

Transverse vs torsional ultrasound: prospective randomized contralaterally controlled study comparing two phacoemulsification-system handpieces.

PubMed

Assil, Kerry K; Harris, Lindsay; Cecka, Jeannie

2015-01-01

To compare surgical efficiency and multiple early clinical outcome variables in eyes undergoing phacoemulsification using either transversal or torsional ultrasound systems. Assil Eye Institute, Beverly Hills, CA, USA. Prospective, randomized, clinician-masked, contralaterally controlled single-center evaluation. Patients seeking cataract removal in both eyes with implantation of multifocal intraocular lenses were randomly assigned to one of two treatment rooms for phacoemulsification with either a transverse ultrasound system or torsional handpiece system. The contralateral eye was treated at a later date with the alternate device. A total of 54 eyes of 27 patients having similar degrees of cataract, astigmatism, and visual potential were included. All operative data were collected for analysis, and patients were followed for 3 months after surgery. Similar visual acuity was reported at all postoperative visits between the two groups. Mean phacoemulsification time and total power required were both significantly lower with the transverse system than with the torsional technique (P<0.05 for both). Similarly, mean total balanced salt solution used was significantly less with the transverse system vs torsional (P<0.05). Postoperative safety demonstrated significantly lower endothelial cell loss at 1 day and 1 month (P<0.05) with transverse vs torsional. Macular swelling was less at 1 week, 1 month, and 3 months with transverse vs torsional, although the difference did not achieve significance (P=0.1) at any single time point. Clinically detectable corneal edema was reported less frequently at all postoperative time points with the transverse system. The transverse ultrasound system was found to be possibly associated with less balanced salt-solution use, less phacoemulsification time, and less power required than the torsional phaco system. Postoperative data suggested that improved phaco efficiency may translate to a better overall safety profile for the patient.

Type of mask may impact on continuous positive airway pressure adherence in apneic patients.

PubMed

Borel, Jean Christian; Tamisier, Renaud; Dias-Domingos, Sonia; Sapene, Marc; Martin, Francis; Stach, Bruno; Grillet, Yves; Muir, Jean François; Levy, Patrick; Series, Frederic; Pepin, Jean-Louis

2013-01-01

In obstructive sleep apnea patients (OSA), continuous positive airway pressure (CPAP) adherence is crucial to improve symptoms and cardiometabolic outcomes. The choice of mask may influence CPAP adherence but this issue has never been addressed properly. To evaluate the impact of nasal pillows, nasal and oronasal masks on CPAP adherence in a cohort of OSA. Newly CPAP treated OSA participating in "Observatoire Sommeil de la Fédération de Pneumologie", a French national prospective cohort, were included between March 2009 and December 2011. Anthropometric data, medical history, OSA severity, sleepiness, depressive status, treatment modalities (auto-CPAP versus fixed pressure, pressure level, interface type, use of humidifiers) and CPAP-related side effects were included in multivariate analysis to determine independent variables associated with CPAP adherence. 2311 OSA (age = 57(12) years, apnea+hypopnea index = 41(21)/h, 29% female) were included. Nasal masks, oronasal masks and nasal pillows were used by 62.4, 26.2 and 11.4% of the patients, respectively. In univariate analysis, oronasal masks and nasal pillows were associated with higher risk of CPAP non-adherence. CPAP non-adherence was also associated with younger age, female gender, mild OSA, gastroesophageal reflux, depression status, low effective pressure and CPAP-related side effects. In multivariate analysis, CPAP non-adherence was associated with the use of oronasal masks (OR = 2.0; 95%CI = 1.6; 2.5), depression, low effective pressure, and side effects. As oronasal masks negatively impact on CPAP adherence, a nasal mask should be preferred as the first option. Patients on oronasal masks should be carefully followed.

Undersampling strategies for compressed sensing accelerated MR spectroscopic imaging

NASA Astrophysics Data System (ADS)

Vidya Shankar, Rohini; Hu, Houchun Harry; Bikkamane Jayadev, Nutandev; Chang, John C.; Kodibagkar, Vikram D.

2017-03-01

Compressed sensing (CS) can accelerate magnetic resonance spectroscopic imaging (MRSI), facilitating its widespread clinical integration. The objective of this study was to assess the effect of different undersampling strategy on CS-MRSI reconstruction quality. Phantom data were acquired on a Philips 3 T Ingenia scanner. Four types of undersampling masks, corresponding to each strategy, namely, low resolution, variable density, iterative design, and a priori were simulated in Matlab and retrospectively applied to the test 1X MRSI data to generate undersampled datasets corresponding to the 2X - 5X, and 7X accelerations for each type of mask. Reconstruction parameters were kept the same in each case(all masks and accelerations) to ensure that any resulting differences can be attributed to the type of mask being employed. The reconstructed datasets from each mask were statistically compared with the reference 1X, and assessed using metrics like the root mean square error and metabolite ratios. Simulation results indicate that both the a priori and variable density undersampling masks maintain high fidelity with the 1X up to five-fold acceleration. The low resolution mask based reconstructions showed statistically significant differences from the 1X with the reconstruction failing at 3X, while the iterative design reconstructions maintained fidelity with the 1X till 4X acceleration. In summary, a pilot study was conducted to identify an optimal sampling mask in CS-MRSI. Simulation results demonstrate that the a priori and variable density masks can provide statistically similar results to the fully sampled reference. Future work would involve implementing these two masks prospectively on a clinical scanner.

Clay jojoba oil facial mask for lesioned skin and mild acne--results of a prospective, observational pilot study.

PubMed

Meier, Larissa; Stange, Rainer; Michalsen, Andreas; Uehleke, Bernhard

2012-01-01

External application of clay facial masks is a cosmetic procedure generally used to reduce skin lesions and to improve overall skin condition. Collecting pilot data about self-treatment with clay jojoba oil masks on participants with acne-prone, lesioned skin and acne. Open, prospective, observational pilot study: Participants received written information, instructions, and questionnaires without direct contact with the study physician. For 6 weeks, they applied the masks 2-3 times per week. The primary outcome is the difference of skin lesions: baseline vs. after 6 weeks. 194 participants (192 female, 2 male, mean age (± SE) (32.3 ± 0.7 years) returned questionnaires and diaries. 133 of these participants returned complete and precise lesion counts (per-protocol (PP) collective). A 54% mean reduction in total lesion count was observed after 6 weeks of treatment with clay facial mask. Both inflammatory and non-inflammatory skin lesions were reduced significantly after treatment compared to baseline: Median counts (MC) of pustules per affected participant were reduced from 7.0 ± 0.9 to 3.0 ± 0.5 (mean individual reduction (MIR) = 49.4%), the MC of the papules from 3.5 ± 2.2 to 1.0 ± 0.4 (MIR = 57.3%), the MC of cysts from 2.0 ± 0.8 to 0.5 ± 0.4 (MIR = 68.6%) and the MC of comedones from 26.5 ± 6.3 to 16.0 ± 4.0 (MIR = 39.1%). DLQI-average score decreased from 5.0 ± 4.5 (mean ± SE) before to 2.1 ± 2.8 after treatment. The present study gives preliminary evidence that healing clay jojoba oil facial masks can be effective treatment for lesioned skin and mild acne vulgaris. Copyright © 2012 S. Karger AG, Basel.

M&A For Lithography Of Sparse Arrays Of Sub-Micrometer Features

DOEpatents

Brueck, Steven R.J.; Chen, Xiaolan; Zaidi, Saleem; Devine, Daniel J.

1998-06-02

Methods and apparatuses are disclosed for the exposure of sparse hole and/or mesa arrays with line:space ratios of 1:3 or greater and sub-micrometer hole and/or mesa diameters in a layer of photosensitive material atop a layered material. Methods disclosed include: double exposure interferometric lithography pairs in which only those areas near the overlapping maxima of each single-period exposure pair receive a clearing exposure dose; double interferometric lithography exposure pairs with additional processing steps to transfer the array from a first single-period interferometric lithography exposure pair into an intermediate mask layer and a second single-period interferometric lithography exposure to further select a subset of the first array of holes; a double exposure of a single period interferometric lithography exposure pair to define a dense array of sub-micrometer holes and an optical lithography exposure in which only those holes near maxima of both exposures receive a clearing exposure dose; combination of a single-period interferometric exposure pair, processing to transfer resulting dense array of sub-micrometer holes into an intermediate etch mask, and an optical lithography exposure to select a subset of initial array to form a sparse array; combination of an optical exposure, transfer of exposure pattern into an intermediate mask layer, and a single-period interferometric lithography exposure pair; three-beam interferometric exposure pairs to form sparse arrays of sub-micrometer holes; five- and four-beam interferometric exposures to form a sparse array of sub-micrometer holes in a single exposure. Apparatuses disclosed include arrangements for the three-beam, five-beam and four-beam interferometric exposures.

Metronome improves compression and ventilation rates during CPR on a manikin in a randomized trial.

PubMed

Kern, Karl B; Stickney, Ronald E; Gallison, Leanne; Smith, Robert E

2010-02-01

We hypothesized that a unique tock and voice metronome could prevent both suboptimal chest compression rates and hyperventilation. A prospective, randomized, parallel design study involving 34 pairs of paid firefighter/emergency medical technicians (EMTs) performing two-rescuer CPR using a Laerdal SkillReporter Resusci Anne manikin with and without metronome guidance was performed. Each CPR session consisted of 2 min of 30:2 CPR with an unsecured airway, then 4 min of CPR with a secured airway (continuous compressions at 100 min(-1) with 8-10 ventilations/min), repeated after the rescuers switched roles. The metronome provided "tock" prompts for compressions, transition prompts between compressions and ventilations, and a spoken "ventilate" prompt. During CPR with a bag/valve/mask the target compression rate of 90-110 min(-1) was achieved in 5/34 CPR sessions (15%) for the control group and 34/34 sessions (100%) for the metronome group (p<0.001). An excessive ventilation rate was not observed in either the metronome or control group during CPR with a bag/valve/mask. During CPR with a bag/endotracheal tube, the target of both a compression rate of 90-110 min(-1) and a ventilation rate of 8-11 min(-1) was achieved in 3/34 CPR sessions (9%) for the control group and 33/34 sessions (97%) for the metronome group (p<0.001). Metronome use with the secured airway scenario significantly decreased the incidence of over-ventilation (11/34 EMT pairs vs. 0/34 EMT pairs; p<0.001). A unique combination tock and voice prompting metronome was effective at directing correct chest compression and ventilation rates both before and after intubation. Copyright 2009 Elsevier Ireland Ltd. All rights reserved.

Evaluation of orally administered robenacoxib versus ketoprofen for treatment of acute pain and inflammation associated with musculoskeletal disorders in cats.

PubMed

Giraudel, Jerome M; Gruet, Philippe; Alexander, Debbie G; Seewald, Wolfgang; King, Jonathan N

2010-07-01

To evaluate the efficacy and tolerability of oral administration of robenacoxib for treatment of acute pain and inflammation associated with musculoskeletal disorders in cats. 155 cats requiring relief of signs of pain and inflammation associated with acute musculoskeletal disorders. The study was a multicenter, prospective, randomized, masked, noninferiority field trial. Cats were allocated randomly to 1 of 3 treatment groups: group 1 (1.0 to 2.4 mg of robenacoxib/kg, q 24 h), group 2 (1.0 to 2.4 mg of robenacoxib/kg, q 12 h [daily dosage, 2.0 to 4.8 mg/kg]), and group 3 (ketoprofen [mean dosage, 1 mg/kg, q 24 h]). All cats were administered tablets PO for 5 or 6 days. The primary efficacy endpoint was the investigator global assessment score, which was the sum of scores of signs of pain, inflammation, and mobility assessed in a masked manner by veterinary investigators at baseline, day 2, and day 4 or 5. Cat owners monitored in a nonmasked manner secondary responses by observation of cats' activity, behavior, appetite, and interactions. Safety was assessed by monitoring adverse events, clinical signs, and hematologic and plasma biochemical variables (before and after treatment). No significant differences were detected among the 3 treatment groups for any primary or secondary efficacy endpoints or for tolerability variables. Robenacoxib tablets administered once daily were significantly more palatable than ketoprofen tablets. Robenacoxib tablets administered once daily had noninferior efficacy and tolerability, and superior palatability, compared with the active control drug, ketoprofen, for the treatment of signs of acute pain and inflammation associated with musculoskeletal disorders in cats.

Double-blind, placebo-controlled pilot study of adjunctive quetiapine SR in the treatment of PMS/PMDD.

PubMed

Jackson, Christine; Pearson, Brenda; Girdler, Susan; Johnson, Jacqueline; Hamer, Robert M; Killenberg, Susan; Meltzer-Brody, Samantha

2015-11-01

Premenstrual dysphoric disorder (PMDD), a more severe form of premenstrual syndrome (PMS), afflicts 5-8% of reproductive age women and results in significant functional impairment. We conducted a double-blind, placebo-controlled trial of adjunctive quetiapine in patients with PMS/PMDD who had inadequate response to selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor therapy for their symptoms. A PMS/PMDD diagnosis was confirmed by 2-month prospective diagnostic assessment of PMS/PMDD using the Prospective Record of the Impact and Severity of Premenstrual Symptoms (PRISM) calendar. Women were randomized equally to receive quetiapine sustained-release (SR) or placebo (25-mg starting dose) during the luteal phase for 3 months. Outcome variables included the Hamilton Depression and Anxiety Scales, Clinical Global Impression Scale, and PRISM. Twenty women were enrolled in the treatment phase. Although the study was underpowered, greater reductions in luteal phase mood ratings were observed in the quetiapine group on the 17-item Hamilton Depression Rating Scale, Clinical Global Impression improvement rating, and PRISM daily score. The quetiapine group showed most improvement in symptoms of mood lability, anxiety, and irritability. This small double-blind study suggests that adjunctive treatment with quetiapine SR may be a useful addition to selective serotonin reuptake inhibitor therapy in women with PMS/PMDD by reducing symptoms and improving quality of life. Copyright © 2015 John Wiley & Sons, Ltd.

Double-dose, new-generation proton pump inhibitors do not improve Helicobacter pylori eradication rate.

PubMed

Choi, Hyo Sun; Park, Dong Il; Hwang, Sang Jun; Park, Jung Sik; Kim, Hong Joo; Cho, Yong Kyun; Sohn, Chong Il; Jeon, Woo Kyu; Kim, Byung Ik

2007-12-01

Up to present, omeprazole plus two antibiotics are used for Helicobacter pylori eradication therapy . Few studies have compared double-dose new-generation, proton pump inhibitors (PPI) with omeprazole. Therefore, we conducted a randomized, prospective study to evaluate differences in H. pylori eradication rates by PPI type. Between January 2006 and December 2006, 576 consecutive patients with proven H. pylori infection were enrolled prospectively. Four different PPIs [omeprazole 20 mg b.i.d. (old generation), or pantoprazole 40 mg b.i.d., rabeprazole 20 mg b.i.d., or esomeprazole 40 mg b.i.d. (new generation)] were added to clarithromycin (500 mg b.i.d.) and amoxicillin (1 g b.i.d.) for 1 week. By intention-to-treat analysis, no difference was found between the eradication rates of these four PPIs: 64.9% (omeprazole, n = 148), 69.3% (pantoprazole, n = 140), 69.3% (rabeprazole, n = 140), and 72.9% (esomoprazole, n = 148). When eradication rates were analyzed according to whether patients had an ulcer or not on a per-protocol basis, no difference was found between the eradication rates of the four PPIs. However, side-effects were more common in the esomeprazole-based triple therapy group than in the other groups (p < .05). No convincing evidence was obtained that double-dose new-generation PPIs have better H. pylori eradication rates and tolerability than omeprazole.

Comparison through a prospective and randomized study of two replenishment methods at polyvalent hospitalization units with two-bin storage systems

PubMed

Bernal, José Luis; Mera-Flores, Ana María; Baena Lázaro, Pedro Pablo; Sebastián Viana, Tomás

2017-11-27

Two-bin storage systems increase nursing staff satisfaction and decrease inventories, but the implications that logistic staff would determine the needs of replenishment are unknown. This study aimed to evaluate whether entrust to logistics staff this responsibility at the polyvalent hospitalization units with two-bin storage is associated with higher risk of outstanding orders. This was a prospective randomized experiment whit masking. Outstanding orders were considered variable response, those corresponding to assessments of the logistics staff were included in the control group and those corresponding to the nursing staff in the control group. Concordance between observers was analyzed using the Bland-Altman method; the difference between groups, with the U of Mann-Whitney and the cumulative incidence of outstanding orders and their relative risk was calculated. The mean amount requested by the logistic and nursing staff was 29.9 (SD:167.4) and 36 (SD:190) units respectively, the mean difference between observers was 6.11 (SD:128.95) units and no significant differences were found between groups (p = 0.430). The incidence of outstanding orders was 0.64% in the intervention group and 0.15% in the control group; the relative risk, 2.31 (0.83 - 6.48) and the number of cases required for an outstanding order, 516. Outstanding order relative risk is not associated with the category of the staff that identifies the replenishment needs at the polyvalent hospitalization units.

Effects of vibration therapy on hormone response and stress in severely disabled patients: a double-blind randomized placebo-controlled clinical trial.

PubMed

Seco, J; Rodríguez-Pérez, V; López-Rodríguez, A F; Torres-Unda, J; Echevarria, E; Díez-Alegre, M I; Ortega, A; Morán, P; Mendoza-Laíz, N; Abecia Inchaurregui, L C

2015-01-01

To assess the effects of vibration therapy (VT) on quality of life and hormone response in severely disabled patients compared with placebo. A longitudinal prospective, double-blind, randomized placebo-controlled trial, with pre and postintervention assessments. A total of 20 severely disabled individuals were recruited from a National Reference Centre in Spain: 13 (65%) men and 7 (35%) women, 45.5 ± 9.32 years of age (range 41: 22-63). We evaluated their physical stress and state anxiety. No statistically significant changes were found in the socio-psychological variables studied, while in the experimental group state anxiety decreased significantly with p < 0.01 (Z = 2.38; one-tailed p = .009) and, among the biological variables, the level of cortisol fell (p = 0.03). Short periods of exposure to low-frequency and low-amplitude local vibration are a safe and effective mechanical stimulus that can have a positive effect in terms of hormone response. VT can be considered to have an anti-stress effect. © 2013 Association of Rehabilitation Nurses.

Evaluation of homeopathic Arnica montana for ecchymosis after upper blepharoplasty: a placebo-controlled, randomized, double-blind study.

PubMed

Kotlus, Brett S; Heringer, Dustin M; Dryden, Robert M

2010-01-01

Ecchymosis is commonly encountered after upper eyelid blepharoplasty. The use of homeopathic preparations of Arnica montana, a flowering herb, has been advocated by physicians, patients, and manufacturers for reduction of postsurgical ecchymosis. The authors evaluate its efficacy after upper eyelid blepharoplasty. A prospective, placebo-controlled, double-blind study was performed in which patients were randomly assigned to the administration of homeopathic A. montana or placebo concurrent with unilateral upper eyelid blepharoplasty followed by contralateral treatment at least 1 month later. Ecchymosis was evaluated at days 3 and 7 by rank order of severity and measurement of surface area of observable ecchymosis. There was no statistically significant difference in area of ecchymosis or rank order of ecchymosis severity for days 3 and 7 after treatment with A. montana versus placebo. Additionally, there was no difference in ease of recovery per patient report, and there was no difference in the rate of ecchymosis resolution. The authors find no evidence that homeopathic A. montana, as used in this study, is beneficial in the reduction or the resolution of ecchymosis after upper eyelid blepharoplasty.

Moisturizers are effective in the treatment of xerosis irrespectively from their particular formulation: results from a prospective, randomized, double-blind controlled trial.

PubMed

Shim, J H; Park, J H; Lee, J H; Lee, D Y; Lee, J H; Yang, J M

2016-02-01

Many companies claim that their moisturizers are superior to others based on their ingredients. To compare the efficacy and safety of the most popular moisturizers in the field. A randomized, double-blind, controlled study was performed on 80 patients with moderate to severe xerosis. The test agents included the newly developed cream containing topical recombinant human epidermal growth factor (EGF), its vehicle without EGF and four additional therapeutic moisturizers. The study subjects applied the test agents on designated skin areas twice daily for 4 weeks. All of the clinical assessments and non-invasive objective measurements were performed at baseline, and on days 14 and 28 of the study. All of the test agents significantly improved the clinical symptoms of xerosis. The biophysical parameters similarly improved from baseline (P < 0.05). None of the test agents performed significantly better than did another. In the treatment of xerosis, consistent and regular moisturizer use is much more important than the moisturizer's particular formulation. © 2015 European Academy of Dermatology and Venereology.

Anesthetic efficacy of articaine for inferior alveolar nerve blocks in patients with irreversible pulpitis.

PubMed

Claffey, Elizabeth; Reader, Al; Nusstein, John; Beck, Mike; Weaver, Joel

2004-08-01

The purpose of this prospective, randomized, double-blind study was to compare the anesthetic efficacy of 4% articaine with 1:100,000 epinephrine to 2% lidocaine with 1:100,000 epinephrine for inferior alveolar nerve blocks in patients experiencing irreversible pulpitis in mandibular posterior teeth. Seventy-two emergency patients diagnosed with irreversible pulpitis of a mandibular posterior tooth randomly received, in a double-blind manner, 2.2 ml of 4% articaine with 1:100,000 epinephrine or 2.2 ml of 2% lidocaine with 1:100,000 epinephrine using a conventional inferior alveolar nerve block. Endodontic access was begun 15 min after solution deposition, and all patients were required to have profound lip numbness. Success was defined as none or mild pain (Visual Analogue Scale recordings) on endodontic access or initial instrumentation. The success rate for the inferior alveolar nerve block using articaine was 24% and for the lidocaine solution success was 23%. There was no significant difference (p = 0.89) between the articaine and lidocaine solutions. Neither solution resulted in an acceptable rate of anesthetic success in patients with irreversible pulpitis.

Face mask ventilation in edentulous patients: a comparison of mandibular groove and lower lip placement.

PubMed

Racine, Stéphane X; Solis, Audrey; Hamou, Nora Ait; Letoumelin, Philippe; Hepner, David L; Beloucif, Sadek; Baillard, Christophe

2010-05-01

In edentulous patients, it may be difficult to perform face mask ventilation because of inadequate seal with air leaks. Our aim was to ascertain whether the "lower lip" face mask placement, as a new face mask ventilation method, is more effective at reducing air leaks than the standard face mask placement. Forty-nine edentulous patients with inadequate seal and air leak during two-hand positive-pressure ventilation using the ventilator circle system were prospectively evaluated. In the presence of air leaks, defined as a difference of at least 33% between inspired and expired tidal volumes, the mask was placed in a lower lip position by repositioning the caudal end of the mask above the lower lip while maintaining the head in extension. The results are expressed as mean +/- SD or median (25th-75th percentiles). Patient characteristics included age (71 +/- 11 yr) and body mass index (24 +/- 4 kg/m2). By using the standard method, the median inspired and expired tidal volumes were 450 ml (400-500 ml) and 0 ml (0-50 ml), respectively, and the median air leak was 400 ml (365-485 ml). After placing the mask in the lower lip position, the median expired tidal volume increased to 400 ml (380-490), and the median air leak decreased to 10 ml (0-20 ml) (P < 0.001 vs. standard method). The lower lip face mask placement with two hands reduced the air leak by 95% (80-100%). In edentulous patients with inadequate face mask ventilation, the lower lip face mask placement with two hands markedly reduced the air leak and improved ventilation.

Left ventricular mass of persistent masked hypertension in Hong Kong Chinese adolescents: a 4-year follow-up study.

PubMed

Yam, Man-Ching; So, Hung-Kwan; Kwok, Sit-Yee; Lo, Fung-Cheung; Mok, Chi-Fung; Leung, Chuk-Kwan; Yip, Wai-Kwok; Sung, Yn-Tz

2018-06-01

In our previous study, the prevalence of childhood masked hypertension was 11%. This study aims to assess the left ventricular mass index of persistent masked hypertension and determine the factors of elevated left ventricular mass index in Hong Kong Chinese adolescents from a community cohort. Community prospective cohort study, follow-up of a case-control study in community. Patients with masked hypertension at baseline were invited to recheck ambulatory blood pressure for the persistence of masked hypertension. A total of 144 out of 165 patients with masked hypertension in the 2011/2012 ambulatory blood pressure survey consented to participate in the study. In all, 48 patients were found to have persistent masked hypertension by ambulatory blood pressure rechecking and were matched with normotensive controls by sex, age, and body height. The left ventricular mass (117.3±39.9 g versus 87.0±28.2 g versus 102.0±28.2 g) and left ventricular mass index (30.1±8.4 g/m2.7 versus 23.9±6.3 g/m2.7 versus 25.1±5.7 g/m2.7) were significantly higher in the persistent masked hypertension group (p<0.0001) compared with the patients without persistent masked hypertension and controls. In multivariate linear regression analysis, left ventricular mass index was found to be higher in male gender (β=4.874, p<0.0001) and the patients with persistent masked hypertension (β=2.796, p=0.003). In addition, left ventricular mass index was positively associated with body mass index z-score (β=3.045, p<0.0001) and low-density lipoprotein cholesterol concentration (β=1.634, p=0.015). Persistent masked hypertension in adolescents is associated with elevated left ventricular mass index.

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.

The Effect of a Diving Mask on Intraocular Pressure in a Healthy Population.

PubMed

Goenadi, Catherina Josephine; Law, David Zhiwei; Lee, Jia Wen; Ong, Ee Lin; Chee, Wai Kitt; Cheng, Jason

2016-01-01

Swimming goggles increase the intraocular pressure (IOP) via the periorbital frame pressure and suction effect. In comparison, diving masks have a larger frame rim and incorporate the nose. The exact effect(s) of diving masks on IOP is unknown. This study evaluates the influence of diving masks on IOP in normal, healthy subjects. Tonometry was performed in both eyes of all subjects with an AVIA(®)Tono-Pen by a single investigator. Measurements were taken at baseline without the diving mask and with the subjects wearing a small-volume, double-window diving mask, but with the mask lenses removed. Two IOP readings in each eye were measured, and an additional reading was measured if the difference between the initial 2 was ≥2 mm Hg. Central corneal thickness (CCT) was also measured in each eye, using a contact pachymeter (OcuScan(®)Alcon). Forty eyes of 20 healthy volunteers (age 29.7 ± 9.3 years; range 21-52) were included. The mean CCT was 544.4 ± 43.5 µm. The mean IOP before the diving mask was worn had been 17.23 ± 2.18 mm Hg (n = 40). The IOP decreased by 0.43 mm Hg (p $1003c; 0.05) to 16.80 ± 2.57 mm Hg after the diving mask had been put on. There was no correlation between IOP change and age (r = 0.143, p = 0.337), gender (r = -0.174, p = 0.283) or CCT (r = -0.123, p = 0.445). There was no increase in IOP after the diving mask had been worn. A small but statistically significant decrease in IOP was observed. This study demonstrates that unlike swimming goggles, the strap tension and frame pressure on the periorbital tissue from a diving mask does not increase IOP. Diving masks may be a suitable alternative to swimming goggles for patients with advanced glaucoma or glaucoma filtration surgery.

The Effect of a Diving Mask on Intraocular Pressure in a Healthy Population

PubMed Central

Goenadi, Catherina Josephine; Law, David Zhiwei; Lee, Jia Wen; Ong, Ee Lin; Chee, Wai Kitt; Cheng, Jason

2016-01-01

Purpose Swimming goggles increase the intraocular pressure (IOP) via the periorbital frame pressure and suction effect. In comparison, diving masks have a larger frame rim and incorporate the nose. The exact effect(s) of diving masks on IOP is unknown. This study evaluates the influence of diving masks on IOP in normal, healthy subjects. Methods Tonometry was performed in both eyes of all subjects with an AVIA®Tono-Pen by a single investigator. Measurements were taken at baseline without the diving mask and with the subjects wearing a small-volume, double-window diving mask, but with the mask lenses removed. Two IOP readings in each eye were measured, and an additional reading was measured if the difference between the initial 2 was ≥2 mm Hg. Central corneal thickness (CCT) was also measured in each eye, using a contact pachymeter (OcuScan®Alcon). Results Forty eyes of 20 healthy volunteers (age 29.7 ± 9.3 years; range 21–52) were included. The mean CCT was 544.4 ± 43.5 µm. The mean IOP before the diving mask was worn had been 17.23 ± 2.18 mm Hg (n = 40). The IOP decreased by 0.43 mm Hg (p $1003c; 0.05) to 16.80 ± 2.57 mm Hg after the diving mask had been put on. There was no correlation between IOP change and age (r = 0.143, p = 0.337), gender (r = −0.174, p = 0.283) or CCT (r = −0.123, p = 0.445). Conclusion There was no increase in IOP after the diving mask had been worn. A small but statistically significant decrease in IOP was observed. This study demonstrates that unlike swimming goggles, the strap tension and frame pressure on the periorbital tissue from a diving mask does not increase IOP. Diving masks may be a suitable alternative to swimming goggles for patients with advanced glaucoma or glaucoma filtration surgery. PMID:27462262

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 Effect of Dextromethorphan Premedication on Cough and Patient Tolerance During Flexible Bronchoscopy: A Randomized, Double-blind, Placebo-controlled Trial.

PubMed

Amini, Shahideh; Peiman, Soheil; Khatuni, Mahdi; Ghalamkari, Marziyeh; Rahimi, Besharat

2017-10-01

Patients undergoing bronchoscopy can experience problems such as anxiety and cough, requiring various doses of sedatives and analgesics. The purposes of this study were to investigate the effect of premedication with dextromethorphan on patients' cough and anxiety, and the use of analgesics/sedatives during flexible bronchoscopy (FB). A randomized, double-blind, placebo-controlled, prospective study was performed to assess the effect of dextromethorphan premedication on patients who underwent diagnostic bronchoscopy. Seventy patients included in this study were randomly allocated into 2 groups: group A consisted of 35 patients who received dextromethorphan before FB; and group B consisted of 35 patients who received a placebo. A questionnaire was given to the patients and bronchoscopist about perception of cough, anxiety, and discomfort. The amount of sedative medication and lidocaine use during the procedure and the procedure time were recorded. The group that was premedicated with dextromethorphan had lower complaint scores, significantly less coughing, significantly less stress assessed by the patient and the physician evaluation, shorter total procedure time, and fewer midazolam requirements during FB (P-value <0.05). Considering its safety profile, dextromethorphan premedication is an effective approach to facilitate the performance of FB for the physician, and could improve patient comfort.

Intraoperative low-dose ketamine infusion reduces acute postoperative pain following total knee replacement surgery: a prospective, randomized double-blind placebo-controlled trial.

PubMed

Cengiz, Pelin; Gokcinar, Derya; Karabeyoglu, Isil; Topcu, Hulya; Cicek, Gizem Selen; Gogus, Nermin

2014-05-01

To evaluate the effect of intraoperative low-dose ketamine with general anesthesia on postoperative pain after total knee replacement surgery. A randomized, double-blind comparative study. Ankara Numune Training and Research Hospital, Turkey, from January and June 2011. Sixty adults undergoing total knee arthroplasty were enrolled in this study. The patients were randomly allocated into two groups of equal size to receive either racemic ketamine infusion (6 μg/kg/minute) or the same volume of saline. A visual analogue scale (VAS) was used to measure each patient's level of pain at 1, 3, 6, 12, and 24 hours after surgery. Time to first analgesic request, postoperative morphine consumption and the incidence of side effects were also recorded. Low-dose ketamine infusion prolonged the time to first analgesic request. It also reduced postoperative cumulative morphine consumption at 1, 3, 6, 12, and 24 hours postsurgery (p < 0.001). Postoperative VAS scores were also significantly lower in the ketamine group than placebo, at all observation times. Incidences of side effects were similar in both study groups. Intraoperative continuous low-dose ketamine infusion reduced pain and postoperative analgesic consumption without affecting the incidence of side effects.

Hyoscine N-Butylbromide for Preventing Propofol Injection Pain: A Randomized, Placebo-Controlled and Double-Blind Study

PubMed Central

Sargın, Mehmet; Uluer, Mehmet Selçuk; Aydoğan, Eyüp

2018-01-01

Objective In this study, the aim was to investigate the effect of hyoscine N-butylbromide (HnBB) pretreatment on pain during propofol injection. Subjects and Methods In this prospective, randomized, placebo-controlled and double-blind trial, 60 patients scheduled to undergo routine outpatient surgery under general anesthesia were randomly allocated to 2 groups, the HnBB (n = 30) and sodium chloride (n = 30) groups. Twenty seconds after the injection of 20 mg HnBB or 0.9 % sodium chloride, a 50-mg dose of propofol was injected in 2–3 s. Ten seconds later, the pain intensity was assessed using a 4-point scale: no pain (0), mild (1), moderate (2), and severe (3) pain. The Student t test was used for the analysis of parametric data and the Pearson χ2 test for categorical data. Results The occurrence of pain in the HnBB group (43.3%) was significantly lower than the control group (73.3%) (p < 0.018). Of the 30 patients in each group, 10 in the control group and 3 in the HnBB group experienced severe pain (p = 0.001). Conclusions Pretreatment with 20 mg HnBB significantly reduced propofol injection pain compared to placebo. PMID:29402789

Systematic review using meta-analyses to estimate dose-response relationships between iodine intake and biomarkers of iodine status in different population groups.

PubMed

Ristić-Medić, Danijela; Dullemeijer, Carla; Tepsić, Jasna; Petrović-Oggiano, Gordana; Popović, Tamara; Arsić, Aleksandra; Glibetić, Marija; Souverein, Olga W; Collings, Rachel; Cavelaars, Adriënne; de Groot, Lisette; van't Veer, Pieter; Gurinović, Mirjana

2014-03-01

The objective of this systematic review was to identify studies investigating iodine intake and biomarkers of iodine status, to assess the data of the selected studies, and to estimate dose-response relationships using meta-analysis. All randomized controlled trials, prospective cohort studies, nested case-control studies, and cross-sectional studies that supplied or measured dietary iodine and measured iodine biomarkers were included. The overall pooled regression coefficient (β) and the standard error of β were calculated by random-effects meta-analysis on a double-log scale, using the calculated intake-status regression coefficient (β) for each individual study. The results of pooled randomized controlled trials indicated that the doubling of dietary iodine intake increased urinary iodine concentrations by 14% in children and adolescents, by 57% in adults and the elderly, and by 81% in pregnant women. The dose-response relationship between iodine intake and biomarkers of iodine status indicated a 12% decrease in thyroid-stimulating hormone and a 31% decrease in thyroglobulin in pregnant women. The model of dose-response quantification used to describe the relationship between iodine intake and biomarkers of iodine status may be useful for providing complementary evidence to support recommendations for iodine intake in different population groups.

Double exposure technique for 45nm node and beyond

NASA Astrophysics Data System (ADS)

Hsu, Stephen; Park, Jungchul; Van Den Broeke, Douglas; Chen, J. Fung

2005-11-01

The technical challenges in using F2 lithography for the 45nm node, along with the insurmountable difficulties in EUV lithography, has driven the semiconductor chipmaker into the low k1 lithography era under the pressure of ever decreasing feature sizes. Extending lithography towards lower k1 puts heavy demand on the resolution enhancement technique (RET), exposure tool, and the need for litho friendly design. Hyper numerical aperture (NA) exposure tools, immersion, and double exposure techniques (DET's) are the promising methods to extend lithography manufacturing to the 45nm node at k1 factors below 0.3. Scattering bars (SB's) have become an integral part of the lithography process as chipmakers move to production at ever lower k1 factors. To achieve better critical dimension (CD) control, polarization is applied to enhance the image contrast in the preferential imaging orientation, which increases the risk of SB printability. The optimum SB width is approximately (0.20 ~ 0.25)*(λ/NA). When the SB width becomes less than the exposure wavelength on the 4X mask, Kirchhoff's scalar theory under predicts the SB intensity. The optical weighting factor of the SB increases (Figure 1b) and the SB's become more susceptible to printing. Meanwhile, under hyper NA conditions, the effectiveness of "subresolution" SB's is significantly diminished. A full-sized scattering bars (FSB) scheme becomes necessary. Double exposure methods, such as using ternary 6% attenuated PSM (attPSM) for DDL, are good imaging solutions that can reach and likely go beyond the 45nm node. Today DDL, using binary chrome masks, is capable of printing 65 nm device patterns. In this work, we investigate the use of DET with 6% attPSM masks to target 45nm node device. The SB scalability and printability issues can be taken cared of by using "mutual trimming", i.e., with the combined energy from the two exposures. In this study, we share our findings of using DET to pattern a 45nm node device design with polarization and immersion. We also explore other double patterning methods which in addition to having two exposures, incorporates double coat/developing/etch processing to break the 0.25 k1 barrier.

Prophylactic dexamethasone decreases the incidence of sore throat and hoarseness after tracheal extubation with a double-lumen endobronchial tube.

PubMed

Park, Sang-Hyun; Han, Sung-Hee; Do, Sang-Hwan; Kim, Jung-Won; Rhee, Ka-young; Kim, Jin-Hee

2008-12-01

Postoperative sore throat and hoarseness are common complications after tracheal intubation, particularly after using a double-lumen endobronchial tube (DLT). We conducted a prospective, randomized, double-blind, placebo-controlled study to evaluate the efficacy of dexamethasone for reducing the incidence and severity of postoperative sore throat and hoarseness. One hundred sixty-six patients (aged 18-75 yr) scheduled for thoracic surgery with a DLT were enrolled. Before induction of general anesthesia, 0.1 mg/kg dexamethasone (Group D1), 0.2 mg/kg dexamethasone (Group D2), or a placebo (Group P) were infused i.v. in a double-blind and prospectively randomized manner. Glottic exposure as defined by Cormack and Lehane score, resistance to DLT insertion, number of intubation attempts, time to achieve intubation, and the duration of tracheal intubation were recorded. At 1 h and 24 h after tracheal extubation, the patients were evaluated for sore throat and hoarseness using a visual analog scale (VAS; where 0 = no pain and 100 = worst pain imaginable). One hour after tracheal extubation, the incidence of postoperative sore throat and hoarseness, along with the severity of sore throat were lower in Group D1 (31%, P = 0.021; 11%, P = 0.003; and VAS 12.4, P < 0.001, respectively) and D2 (11%, P = 0.001; 4%, P = 0.001; and VAS 6.6, P < 0.001, respectively) compared with Group P (53%, 36% and VAS 30.9, respectively). Twenty-four hours after tracheal extubation, the incidence of postoperative sore throat, hoarseness, and the severity of sore throat were significantly lower in Group D2 (27%, P = 0.002; 15%, P = 0.001; and VAS 29.9, P < 0.002, respectively) compared with Group D1 (47%, 31%, and VAS = 43.9, respectively) and Group P (57%, 45%, and VAS = 51.3, respectively). There was no complication associated with the dexamethasone administration. The prophylactic use of 0.2 mg/kg of dexamethasone significantly decreases the incidence and severity of sore throat and hoarseness 1 h and 24 h after tracheal extubation of a DLT.

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.

Levetiracetam for the treatment of alcohol withdrawal syndrome: a multicenter, prospective, randomized, placebo-controlled trial.

PubMed

Richter, Christoph; Hinzpeter, Axel; Schmidt, Folkhard; Kienast, Thorsten; Preuss, Ulrich W; Plenge, Thomas; Heinz, Andreas; Schaefer, Martin

2010-12-01

Treatment of alcohol withdrawal syndrome (AWS) with benzodiazepines is limited by risk of abuse, intoxication, respiratory problems, and liver toxicity. Alternatives such as carbamazepine and valproate may also have safety problems, such as hepatotoxicity or central nervous adverse effects. We therefore investigated the safety and efficacy of levetiracetam (LV), a newer antiepileptic with a potentially favorable adverse-effect profile, for the treatment of AWS. One hundred six patients were enrolled in a prospective, randomized, double-blind, multicenter, placebo-controlled trial. Levetiracetam was administered in a fixed dose schedule over 6 days. Diazepam was added when symptom triggered as rescue medication. Severity of the AWS was measured with the AWS and Clinical Institute Withdrawal Assessment Scale. Although tolerability and safety data were similar in the LV group when compared with placebo, the total daily and weekly dose of diazepam as rescue medication and the severity of alcohol withdrawal symptoms did not differ significantly between groups. Our data so far do not support an additional effect of LV on the reduction of alcohol withdrawal symptoms.

Randomized, Double-Blinded, Double-Dummy, Active-Controlled, and Multiple-Dose Clinical Study Comparing the Efficacy and Safety of Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet and Acarbose in Individuals with Type 2 Diabetes Mellitus

PubMed Central

Chen, Yao

2016-01-01

Aims. To evaluate the efficacy and safety of mulberry twig alkaloid (SZ-A) tablet compared with acarbose in patients with type 2 diabetes. Methods. This clinical trial enrolled 38 patients who were randomized into two groups (SZ-A: 23; acarbose: 15) and were treated for 24 weeks. Patients and clinical trial staffs were masked to treatment assignment throughout the study. The primary outcome measures were glycated hemoglobin (HbA1c) and 1-hour and 2-hour postprandial and fasting plasma glucose levels from baseline to the end of treatment. Analysis included all patients who completed this study. Results. By the end of this study, HbA1c level in SZ-A group was decreased from baseline significantly (P < 0.001). No significant difference was found when compared with acarbose group (P = 0.652). Similarly, 1-hour and 2-hour postprandial plasma glucose levels in SZ-A group were decreased from baseline statistically (P < 0.05), without any significant differences compared with acarbose group (P = 0.748 and 0.558, resp.). The fasting plasma glucose levels were not significantly changed in both groups. One of 23 patients in SZ-A group (4.76%) and 5 of 15 patients in acarbose group (33.33%) suffered from gastrointestinal adverse events. Conclusions. Compared with acarbose, SZ-A tablet was effective and safe in glycemic control in patients with type 2 diabetes. PMID:27547230

Effectiveness of De Qi during acupuncture for the treatment of tinnitus: study protocol for a randomized controlled trial.

PubMed

Xie, Hui; Li, Xinrong; Lai, Jiaqin; Zhou, Yanan; Wang, Caiying; Liang, Jiao

2014-10-15

Acupuncture has been used in China to treat tinnitus for a long time. There is debate as to whether or not De Qi is a key factor in achieving the efficacy of acupuncture. However, there is no sufficient evidence obtained from randomized controlled trials to confirm the role of De Qi in the treatment of acupuncture for tinnitus. This study aims to identify the effect of De Qi for patients who receive acupuncture to alleviate tinnitus by a prospective, double-blind, randomized, sham-controlled trial. This study compares two acupuncture groups (with or without manipulation) in 292 patients with a history of subjective tinnitus. The trial will be conducted in the Teaching Hospital of Chengdu University of Traditional Chinese Medicine. In the study, the patients will be randomly assigned into two groups according to a computer-generated randomization list and assessed prior to treatment. Then, they will receive 5 daily sessions of 30 minutes each time for 4 consecutive weeks and undergo a 12-week follow-up phase. The administration of acupuncture follows the guidelines for clinical research on acupuncture (WHO Regional Publication, Western Pacific Series Number 15, 1995), and is performed double-blind by physicians well-trained in acupuncture. The measures of outcome include the subjective symptoms scores and quantitative sensations of De Qi evaluated by Visual Analog Scales (VAS) and the Chinese version of the 'modified' Massachusetts General Hospital Acupuncture Sensation Scale (C-MMASS). Furthermore, adverse events are recorded and analyzed. If any subjects are withdrawn from the trial, intention-to-treat analysis (ITT) and per-protocol (PP) analysis will be performed. The key features of this trial include the randomization procedures, large sample and the standardized protocol to evaluate De Qi qualitatively and quantitatively in the treatment of acupuncture for tinnitus. The trial will be the first study with a high evidence level in China to assess the efficacy of De Qi in the treatment of tinnitus in a randomized, double-blind, sham-controlled manner. Chinese Clinical Trial Registry: ChiCTR-TRC-14004720 (6 May 2014).

Study protocol and rationale for a randomized double-blinded crossover trial of phentermine-topiramate ER versus placebo to treat binge eating disorder and bulimia nervosa.

PubMed

Dalai, Shebani Sethi; Adler, Sarah; Najarian, Thomas; Safer, Debra Lynn

2018-01-01

Bulimia nervosa (BN) and binge eating disorder (BED) are associated with severe psychological and medical consequences. Current therapies are limited, leaving up to 50% of patients symptomatic despite treatment, underscoring the need for additional treatment options. Qsymia, an FDA-approved medication for obesity, combines phentermine and topiramate ER. Topiramate has demonstrated efficacy for both BED and BN, but limited tolerability. Phentermine is FDA-approved for weight loss. A rationale for combined phentermine/topiramate for BED and BN is improved tolerability and efficacy. While a prior case series exploring Qsymia for BED showed promise, randomized studies are needed to evaluate Qsymia's safety and efficacy when re-purposed in eating disorders. We present a study protocol for a Phase I/IIa single-center, prospective, double-blinded, randomized, crossover trial examining safety and preliminary efficacy of Qsymia for BED and BN. Adults with BED (n=15) or BN (n=15) are randomized 1:1 to receive 12weeks Qsymia (phentermine/topiramate ER, 3.75mg/23mg-15mg/92mg) or placebo, followed by 2-weeks washout and 12-weeks crossover, where those on Qsymia receive placebo and vice versa. Subsequently participants receive 8weeks follow-up off study medications. The primary outcome is the number of binge days/week measured by EDE. Secondary outcomes include average number of binge episodes, percentage abstinence from binge eating, and changes in weight/vitals, eating psychopathology, and mood. To our knowledge this is the first randomized, double-blind protocol investigating the safety and efficacy of phentermine/topiramate in BED and BN. We highlight the background and rationale for this study, including the advantages of a crossover design. Clinicaltrials.gov identifier NCT02553824 registered on 9/17/2015. https://clinicaltrials.gov/ct2/show/NCT02553824. Copyright © 2017 Elsevier Inc. 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.

Visual field protective effect of Erigeron breviscapus (vant.) Hand. Mazz. extract on glaucoma with controlled intraocular pressure: a randomized, double-blind, clinical trial.

PubMed

Zhong, Yisheng; Xiang, Minhong; Ye, Wen; Cheng, Yu; Jiang, Youqin

2010-01-01

To evaluate the visual field protective effect of Erigeron breviscapus (vant.) Hand. Mazz. (EBHM) extract on glaucoma with controlled intraocular pressure (IOP). Forty patients (40 eyes) with primary open-angle glaucoma, visual field defects and a postsurgical IOP of <18 mmHg were enrolled. The EBHM and placebo tablets were given orally according to the randomized and double-blind principle. Two tablets (of either EBHM or placebo) were taken three times a day for a period of 6 months. Patients were examined every 2 months after treatment commenced. At the end of the study, the results were given to the drug manufacturer. All patients completed the prospective, randomized, double-blind, clinical trial. No obvious adverse effects were found in patients during the treatment period. In the placebo group, no significant difference was found in mean defect (MD) or mean sensitivity (MS) between the values at pre-treatment and after 2, 4, and 6 months of treatment. After 6 months of EBHM treatment, the MD was significantly decreased and the MS was significantly increased compared with pre-treatment (p < 0.05). In the patients with moderate and late glaucoma, the MD was significantly decreased and the MS was significantly increased after 2, 4, and 6 months of EBHM treatment compared with pre-treatment. EBHM extract may have a partial protective effect on the visual field of glaucoma patients with controlled IOP. Further studies are needed to determine the safety and effectiveness of long-term EBHM treatment.

Emerging moxifloxacin resistance in Pseudomonas aeruginosa keratitis isolates in South India

PubMed Central

Oldenburg, Catherine E.; Lalitha, Prajna; Srinivasan, Muthiah; Rajaraman, Revathi; Ravindran, Meenakshi; Mascarenhas, Jeena; Borkar, Durga S.; Ray, Kathryn J; Zegans, Michael E.; McLeod, Stephen D.; Porco, Travis C.; Lietman, Thomas M.; Acharya, Nisha R.

2013-01-01

Purpose To describe temporal trends in Pseudomonas aeruginosa resistance to moxifloxacin in keratitis isolates from South India. Methods The Steroids for Corneal Ulcers Trial (SCUT) was a randomized, double-masked, placebo-controlled trial assessing outcomes in patients with culture positive bacterial corneal ulcers randomized to receive prednisolone phosphate or placebo. All patients received moxifloxacin, and susceptibility to moxifloxacin was measured at baseline using Etest. We investigated trends in moxifloxacin susceptibility of P. aeruginosa during 2007, 2008, and 2009 isolated in SCUT in South India. Results There were 89 P. aeruginosa isolates during 2007, 2008, and 2009 in SCUT that were eligible for this study. There was an increase in the proportion of resistant isolates from 19% in 2007 to 52% in 2009 (P=0.02, Chi-square test for trend). Logistic regression showed that there was a 2-fold increase in odds of resistance per one year increase during the study period (OR 2.16, 95% CI 1.09 to 4.26, P=0.027). Conclusions We found a sharp increase in the proportion of isolates that were resistant to moxifloxacin from 2007 to 2009. Further work needs to be done to characterize the nature of this increase. PMID:23662986

Emerging moxifloxacin resistance in Pseudomonas aeruginosa keratitis isolates in South India.

PubMed

Oldenburg, Catherine E; Lalitha, Prajna; Srinivasan, Muthiah; Rajaraman, Revathi; Ravindran, Meenakshi; Mascarenhas, Jeena; Borkar, Durga S; Ray, Kathryn J; Zegans, Michael E; McLeod, Stephen D; Porco, Travis C; Lietman, Thomas M; Acharya, Nisha R

2013-06-01

To describe temporal trends in Pseudomonas aeruginosa resistance to moxifloxacin in keratitis isolates from South India. The Steroids for Corneal Ulcers Trial (SCUT) was a randomized, double-masked, placebo-controlled trial assessing outcomes in patients with culture positive bacterial corneal ulcers randomized to receive prednisolone phosphate or placebo. All patients received moxifloxacin, and susceptibility to moxifloxacin was measured at baseline using Etest. We investigated trends in moxifloxacin susceptibility of P. aeruginosa during 2007, 2008, and 2009 isolated in SCUT in South India. There were 89 P. aeruginosa isolates during 2007, 2008, and 2009 in SCUT that were eligible for this study. There was an increase in the proportion of resistant isolates from 19% in 2007 to 52% in 2009 (p = 0.02, χ(2) test for trend). Logistic regression showed that there was a 2-fold increase in odds of resistance per 1 year increase during the study period (odds ratio 2.16, 95% confidence interval 1.09-4.26, p = 0.027). We found a sharp increase in the proportion of isolates that were resistant to moxifloxacin from 2007 to 2009. Further work needs to be done to characterize the nature of this increase.

Efficacy of etanercept in preventing relapse of uveitis controlled by methotrexate.

PubMed

Foster, C Stephen; Tufail, Fehma; Waheed, Nadia Khalida; Chu, David; Miserocchi, Elisabetta; Baltatzis, Stefanos; Vredeveld, Cindy M

2003-04-01

To evaluate the efficacy of etanercept vs placebo in preventing relapses of uveitis in patients taking methotrexate with control of uveitis and whose methotrexate dosage was being tapered. Patients with chronic or recurrent noninfectious uveitis with inflammation controlled by low-dose methotrexate were randomized to either the drug or placebo group in a double-masked manner, given a methotrexate taper schedule, and followed for 24 weeks. The main outcome measures were control of inflammation, visual acuity, and adverse reactions. Data were analyzed both as an attempt-to-treat analysis and an analysis only of those patients who completed the study. A total of 20 patients were randomized to the drug and placebo groups. Relapse of uveitis occurred in 3 of 10 patients in the treatment group and 5 of 10 patients in the control group. Two patients in the treatment group withdrew prematurely from the study due to adverse effects. There was no significant difference between the treatment and placebo groups with regard to the rate of relapse and the final visual acuity. No patient suffered from any irreversible, long-term morbidity or mortality. Etanercept has no significant efficacy over placebo in preventing relapses of uveitis in patients being tapered from methotrexate.

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.

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

Self-formation of polymer nanostructures in plasma etching: mechanisms and applications

NASA Astrophysics Data System (ADS)

Du, Ke; Jiang, Youhua; Huang, Po-Shun; Ding, Junjun; Gao, Tongchuan; Choi, Chang-Hwan

2018-01-01

In recent years, plasma-induced self-formation of polymer nanostructures has emerged as a simple, scalable and rapid nanomanufacturing technique to pattern sub-100 nm nanostructures. High-aspect-ratio nanostructures (>20:1) are fabricated on a variety of polymer surfaces such as poly(methylmethacrylate) (PMMA), polystyrene (PS), polydimethylsiloxane (PDMS), and fluorinated ethylene propylene (FEP). Sub-100 nm nanostructures (i.e. diameter  ⩽  50 nm) are fabricated in this one-step process without relying on slow and expensive nanolithography techniques. This review starts with discussion of the self-formation mechanisms including surface modulation, random masks, and materials impurities. Emphasis is put on the applications of polymer nanostructures in the fields of hierarchical nanostructures, liquid repellence, adhesion, lab-on-a-chip, surface enhanced Raman scattering (SERS), organic light emitting diode (OLED), and energy harvesting. The unique advantages of this nanomanufacturing technique are illustrated, followed by prospects.

On the benefit of high resolution and low aberrations for in-die mask registration metrology

NASA Astrophysics Data System (ADS)

Beyer, Dirk; Seidel, Dirk; Heisig, Sven; Steinert, Steffen; Töpfer, Susanne; Scherübl, Thomas; Hetzler, Jochen

2014-10-01

With the introduction of complex lithography schemes like double and multi - patterning and new design principles like gridded designs with cut masks the requirements for mask to mask overlay have increased dramatically. Still, there are some good news too for the mask industry since more mask are needed and qualified. Although always confronted with throughput demands, latest writing tool developments are able to keep pace with ever increasing pattern placement specs not only for global signatures but for in-die features within the active area. Placement specs less than 3nm (max. 3 Sigma) are expected and needed in all cases in order to keep the mask contribution to the overall overlay budget at an accepted level. The qualification of these masks relies on high precision metrology tools which have to fulfill stringent metrology as well as resolution constrains at the same time. Furthermore, multi-patterning and gridded designs with pinhole type cut masks are drivers for a paradigm shift in registration metrology from classical registration crosses to in-die registration metrology on production features. These requirements result in several challenges for registration metrology tools. The resolution of the system must be sufficiently high to resolve small production features. At the same time tighter repeatability is required. Furthermore, tool induced shift (TIS) limit the accuracy of in-die measurements. This paper discusses and demonstrates the importance of low illumination wavelength together with low aberrations for best contrast imaging for in-die registration metrology. Typical effects like tool induced shift are analyzed and evaluated using the ZEISS PROVE® registration metrology tool. Additionally, we will address performance gains when going to higher resolution. The direct impact on repeatability for small features by registration measurements will be discussed as well.

Type of Mask May Impact on Continuous Positive Airway Pressure Adherence in Apneic Patients

PubMed Central

Borel, Jean Christian; Tamisier, Renaud; Dias-Domingos, Sonia; Sapene, Marc; Martin, Francis; Stach, Bruno; Grillet, Yves; Muir, Jean François; Levy, Patrick; Series, Frederic; Pepin, Jean-Louis

2013-01-01

Rationale In obstructive sleep apnea patients (OSA), continuous positive airway pressure (CPAP) adherence is crucial to improve symptoms and cardiometabolic outcomes. The choice of mask may influence CPAP adherence but this issue has never been addressed properly. Objective To evaluate the impact of nasal pillows, nasal and oronasal masks on CPAP adherence in a cohort of OSA. Methods Newly CPAP treated OSA participating in “Observatoire Sommeil de la Fédération de Pneumologie”, a French national prospective cohort, were included between March 2009 and December 2011. Anthropometric data, medical history, OSA severity, sleepiness, depressive status, treatment modalities (auto-CPAP versus fixed pressure, pressure level, interface type, use of humidifiers) and CPAP-related side effects were included in multivariate analysis to determine independent variables associated with CPAP adherence. Results 2311 OSA (age = 57(12) years, apnea+hypopnea index = 41(21)/h, 29% female) were included. Nasal masks, oronasal masks and nasal pillows were used by 62.4, 26.2 and 11.4% of the patients, respectively. In univariate analysis, oronasal masks and nasal pillows were associated with higher risk of CPAP non-adherence. CPAP non-adherence was also associated with younger age, female gender, mild OSA, gastroesophageal reflux, depression status, low effective pressure and CPAP-related side effects. In multivariate analysis, CPAP non-adherence was associated with the use of oronasal masks (OR = 2.0; 95%CI = 1.6; 2.5), depression, low effective pressure, and side effects. Conclusion As oronasal masks negatively impact on CPAP adherence, a nasal mask should be preferred as the first option. Patients on oronasal masks should be carefully followed. PMID:23691209

Social learning spreads knowledge about dangerous humans among American crows.

PubMed

Cornell, Heather N; Marzluff, John M; Pecoraro, Shannon

2012-02-07

Individuals face evolutionary trade-offs between the acquisition of costly but accurate information gained firsthand and the use of inexpensive but possibly less reliable social information. American crows (Corvus brachyrhynchos) use both sources of information to learn the facial features of a dangerous person. We exposed wild crows to a novel 'dangerous face' by wearing a unique mask as we trapped, banded and released 7-15 birds at five study sites near Seattle, WA, USA. An immediate scolding response to the dangerous mask after trapping by previously captured crows demonstrates individual learning, while an immediate response by crows that were not captured probably represents conditioning to the trapping scene by the mob of birds that assembled during the capture. Later recognition of dangerous masks by lone crows that were never captured is consistent with horizontal social learning. Independent scolding by young crows, whose parents had conditioned them to scold the dangerous mask, demonstrates vertical social learning. Crows that directly experienced trapping later discriminated among dangerous and neutral masks more precisely than did crows that learned through social means. Learning enabled scolding to double in frequency and spread at least 1.2 km from the place of origin over a 5 year period at one site.

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.

Prospective double-blind clinical trial evaluating the effectiveness of Bromelain in the third molar extraction postoperative period.

PubMed

de la Barrera-Núñez, M-C; Yáñez-Vico, R-M; Batista-Cruzado, A; Heurtebise-Saavedra, J-M; Castillo-de Oyagüe, R; Torres-Lagares, D

2014-03-01

To evaluate the anti-inflammatory and analgesic effect of Bromelain (pineapple extract) administered orally in the postoperative after extraction of impacted lower molars. This is a prospective, placebo-controlled, unicentric, double-blind study; the sample size was 34 patients. The pre and postoperative outcomes, evaluated on the third (D3) and eighth day (D8), included inflamtion, pain and oral aperture, as well as the need for analgesics. One group received Bromelain 150mg per day for three days and 100mg on days 4 to 7. The other group received placebo in the same dosage. All outcomes werrecorded quantitatively and analyzed with the Mann-Whitney U test for independent samples. Although there were no statistically significant differences between the treatment groups, a trend towards less inflammation and improved oral aperture was observed in the group that received Bromelain, compared to the group that received placebo. This trend can be attributed completely to random reasons, since there is no statistical difference in the results. Further studies are necessary to analyze different administration patterns and doses of Bromelain for the use in the postoperative of impacted third molars.

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…

Double-masked, placebo-controlled safety and efficacy trial of diquafosol tetrasodium (INS365) ophthalmic solution for the treatment of dry eye.

PubMed

Tauber, J; Davitt, W F; Bokosky, J E; Nichols, K K; Yerxa, B R; Schaberg, A E; LaVange, L M; Mills-Wilson, M C; Kellerman, D J

2004-11-01

To investigate the safety and efficacy of diquafosol tetrasodium, a P2Y2 receptor agonist that stimulates fluid and mucin secretion on the ocular surface, as a novel topical treatment of dry eye disease. Subjects with dry eye (n=527) were evaluated in a randomized, double-masked, parallel-group trial comparing 24 weeks of treatment with 2 concentrations of diquafosol (1% and 2%) versus placebo instilled 4 times daily. Corneal staining, conjunctival staining, Schirmer tests, and subjective symptoms of dry eye were evaluated. Use of artificial tears was permitted as necessary. Subjects treated with 2% diquafosol had significantly lower corneal staining scores compared with placebo at the 6-week, primary efficacy time point (P<0.001), and superiority continued throughout the 24-week study. Reductions in corneal staining were observed as early as after 2 weeks of treatment, were maintained throughout the 24-week study, and were observed to worsen slightly (toward baseline) when diquafosol treatment was discontinued (week 25). Results for conjunctival staining were consistent with those observed for corneal staining. Schirmer scores at week 6 were significantly higher with diquafosol treatment than with placebo (P

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.

Placement-aware decomposition of a digital standard cells library for double patterning lithography

NASA Astrophysics Data System (ADS)

Wassal, Amr G.; Sharaf, Heba; Hammouda, Sherif

2012-11-01

To continue scaling the circuit features down, Double Patterning (DP) technology is needed in 22nm technologies and lower. DP requires decomposing the layout features into two masks for pitch relaxation, such that the spacing between any two features on each mask is greater than the minimum allowed mask spacing. The relaxed pitches of each mask are then processed on two separate exposure steps. In many cases, post-layout decomposition fails to decompose the layout into two masks due to the presence of conflicts. Post-layout decomposition of a standard cells block can result in native conflicts inside the cells (internal conflict), or native conflicts on the boundary between two cells (boundary conflict). Resolving native conflicts requires a redesign and/or multiple iterations for the placement and routing phases to get a clean decomposition. Therefore, DP compliance must be considered in earlier phases, before getting the final placed cell block. The main focus of this paper is generating a library of decomposed standard cells to be used in a DP-aware placer. This library should contain all possible decompositions for each standard cell, i.e., these decompositions consider all possible combinations of boundary conditions. However, the large number of combinations of boundary conditions for each standard cell will significantly increase the processing time and effort required to obtain all possible decompositions. Therefore, an efficient methodology is required to reduce this large number of combinations. In this paper, three different reduction methodologies are proposed to reduce the number of different combinations processed to get the decomposed library. Experimental results show a significant reduction in the number of combinations and decompositions needed for the library processing. To generate and verify the proposed flow and methodologies, a prototype for a placement-aware DP-ready cell-library is developed with an optimized number of cell views.

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.

Masked Hypertension and Incident Clinic Hypertension Among Blacks in the Jackson Heart Study.

PubMed

Abdalla, Marwah; Booth, John N; Seals, Samantha R; Spruill, Tanya M; Viera, Anthony J; Diaz, Keith M; Sims, Mario; Muntner, Paul; Shimbo, Daichi

2016-07-01

Masked hypertension, defined as nonelevated clinic blood pressure (BP) and elevated out-of-clinic BP may be an intermediary stage in the progression from normotension to hypertension. We examined the associations of out-of-clinic BP and masked hypertension using ambulatory BP monitoring with incident clinic hypertension in the Jackson Heart Study, a prospective cohort of blacks. Analyses included 317 participants with clinic BP <140/90 mm Hg, complete ambulatory BP monitoring, who were not taking antihypertensive medication at baseline in 2000 to 2004. Masked daytime hypertension was defined as mean daytime blood pressure ≥135/85 mm Hg, masked night-time hypertension as mean night-time BP ≥120/70 mm Hg, and masked 24-hour hypertension as mean 24-hour BP ≥130/80 mm Hg. Incident clinic hypertension, assessed at study visits in 2005 to 2008 and 2009 to 2012, was defined as the first visit with clinic systolic/diastolic BP ≥140/90 mm Hg or antihypertensive medication use. During a median follow-up of 8.1 years, there were 187 (59.0%) incident cases of clinic hypertension. Clinic hypertension developed in 79.2% and 42.2% of participants with and without any masked hypertension, 85.7% and 50.4% with and without masked daytime hypertension, 79.9% and 43.7% with and without masked night-time hypertension, and 85.7% and 48.2% with and without masked 24-hour hypertension, respectively. Multivariable-adjusted hazard ratios (95% confidence interval) of incident clinic hypertension for any masked hypertension and masked daytime, night-time, and 24-hour hypertension were 2.13 (1.51-3.02), 1.79 (1.24-2.60), 2.22 (1.58-3.12), and 1.91 (1.32-2.75), respectively. These findings suggest that ambulatory BP monitoring can identify blacks at increased risk for developing clinic hypertension. © 2016 American Heart Association, Inc.

Masked Hypertension and Incident Clinic Hypertension among African Americans in the Jackson Heart Study

PubMed Central

Abdalla, Marwah; Booth, John N.; Seals, Samantha R.; Spruill, Tanya M.; Viera, Anthony J.; Diaz, Keith M.; Sims, Mario; Muntner, Paul; Shimbo, Daichi

2016-01-01

Masked hypertension, defined as non-elevated clinic blood pressure and elevated out-of-clinic blood pressure may be an intermediary stage in the progression from normotension to hypertension. We examined the associations of out-of-clinic blood pressure and masked hypertension using ambulatory blood pressure monitoring with incident clinic hypertension in the Jackson Heart Study, a prospective cohort of African Americans. Analyses included 317 participants with clinic blood pressure <140/90mmHg, complete ABPM, who were not taking antihypertensive medication at baseline in 2000–2004. Masked daytime hypertension was defined as mean daytime blood pressure ≥135/85mmHg; masked nighttime hypertension as mean nighttime blood pressure ≥120/70mmHg; and masked 24-hour hypertension as mean 24-hour blood pressure ≥130/80mmHg. Incident clinic hypertension, assessed at study visits in 2005–2008 and 2009–2012, was defined as the first visit with clinic systolic/diastolic blood pressure ≥140/90mmHg or antihypertensive medication use. During a median follow-up of 8.1 years, there were 187 (59.0%) incident cases of clinic hypertension. Clinic hypertension developed in 79.2% and 42.2% of participants with and without any masked hypertension, 85.7% and 50.4% with and without masked daytime hypertension, 79.9% and 43.7% with and without masked nighttime hypertension and 85.7% and 48.2% with and without masked 24-hour hypertension, respectively. Multivariable-adjusted hazard ratios (95% CI) of incident clinic hypertension for any masked hypertension and masked daytime, nighttime, and 24-hour hypertension were 2.13 (1.51–3.02), 1.79 (1.24–2.60), 2.22 (1.58–3.12), and 1.91 (1.32–2.75), respectively. These findings suggest that ambulatory blood pressure monitoring can identify African Americans at increased risk for developing clinic hypertension. PMID:27185746

Ocular surface disease in patients with glaucoma or ocular hypertension treated with either BAK-preserved latanoprost or BAK-free travoprost

PubMed Central

Katz, Gregory; Springs, Clark L; Craven, E Randy; Montecchi-Palmer, Michela

2010-01-01

Purpose The preservative benzalkonium chloride (BAK) may adversely affect ocular surface health. This study evaluated symptoms of ocular surface disease (OSD) in patients previously treated with a BAK-preserved therapy to lower their intraocular pressure, who either continued that therapy or switched to a BAK-free therapy. Methods Eligible adult patients with ocular hypertension or open-angle glaucoma that had been controlled with BAK-preserved latanoprost 0.005% monotherapy (Xalatan®) for at least one month and had a score of ≥ 13 (0 = none, 100 = most severe) on the Ocular Surface Disease Index (OSDI) questionnaire were entered into this prospective, double-masked, randomized, active-controlled, multicenter trial. By random assignment, patients either continued with BAK-preserved latanoprost 0.005% or transitioned to BAK-free travoprost 0.004% (Travatan Z® ophthalmic solution). OSDI scores were assessed again after six and 12 weeks. Results For the 678 evaluable patients, mean change in OSDI score from baseline to week 12 favored the travoprost 0.004% BAK-free group, but was not statistically different between groups (P = 0.10). When patients with mild OSD at baseline were assessed after 12 weeks, the mean OSDI score was significantly lower (P = 0.04) in the BAK-free travoprost 0.004% group (score = 11.6 ± 10.8 units) than in the BAK-preserved latanoprost 0.005% group (score = 14.4 ± 11.9 units), and a significantly larger percentage (P < 0.01) improved to normal OSDI scores in the BAK-free travoprost 0.004% group (62.9% of group) than in the BAK-preserved latanoprost 0.005% group (47.0% of group). Patients pretreated with BAK-preserved latanoprost 0.005% for >24 months were significantly more likely (P = 0.03) to improve to a normal OSDI score after 12 weeks if they were switched to BAK-free travoprost 0.004% (47.9% of group) than if they remained on BAK-preserved latanoprost 0.005% (33.9% of group). Conclusions Switching from BAK-preserved latanoprost 0.005% to BAK-free travoprost 0.004% yielded significant improvements in symptoms of OSD in patients with glaucoma or ocular hypertension. PMID:21151330

Age-related Cataract in a Randomized Trial of Vitamins E and C in Men

PubMed Central

Christen, William G.; Glynn, Robert J.; Sesso, Howard D.; Kurth, Tobias; MacFadyen, Jean; Bubes, Vadim; Buring, Julie E.; Manson, JoAnn E.; Michael Gaziano, J.

2010-01-01

Objective To test whether supplementation with alternate day vitamin E or daily vitamin C affects the incidence of age-related cataract in a large-scale randomized trial of men. Design Randomized, double-masked, placebo-controlled trial. Participants Eleven thousand five hundred forty-five apparently healthy US male physicians aged 50 years or older who were without a diagnosis of cataract at baseline. Intervention Participants were randomly assigned to receive 400 IU of vitamin E or placebo on alternate days, and 500 mg of vitamin C or placebo daily. Main Outcome Measure Incident cataract responsible for a reduction in best-corrected visual acuity to 20/30 or worse based on self-report confirmed by medical record review. Results After 8 years of treatment and follow-up, a total of 1,174 incident cataracts were confirmed. There were 579 cataracts in the vitamin E treated group and 595 in the vitamin E placebo group (hazard ratio [HR], 0.99; 95 percent confidence interval [CI], 0.88 to 1.11). For vitamin C, there were 593 cataracts in the treated group and 581 in the placebo group (HR, 1.02; CI, 0.91 to 1.14). Conclusions In a large-scale randomized trial of US male physicians, long-term alternate day use of 400 IU of vitamin E and/or daily use of 500 mg of vitamin C had no significant beneficial or harmful effect on the risk of cataract. Application to Clinical Practice Long-term use of vitamin E and/or vitamin C supplements has no appreciable effect on cataract. PMID:21060040

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

PubMed

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

2016-01-01

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

Prospective randomized double-blinded trial comparing 2 anti-MRSA agents with supplemental coverage of cefazolin before lower extremity revascularization.

PubMed

Stone, Patrick A; AbuRahma, Ali F; Campbell, James R; Hass, Stephen M; Mousa, Albeir Y; Nanjundappa, Aravinda; Srivastiva, Mohit; Modak, Asmita; Emmett, Mary

2015-09-01

To compare with antibiotics with methicillin-resistant microbial coverage in a prospective fashion. Current antibiotic prophylaxis for vascular procedures includes a first generation cephalosporin. No changes in recommendations have occurred despite changes in reports of incidence of MRSA related surgical site infections. Does supplemental anti-MRSA prophylactic coverage provide a significant reduction in Gram-positive or MRSA infections? Single center prospective double blinded randomized study of patients undergoing lower extremity vascular procedures from 2011 to 2014. One hundred seventy-eight (178) patients were evaluated at 90 days for surgical site infection. Infections were categorized as early infections less than 30 days of the index procedure and late after 90 days. Early vascular surgical site infection occurred in 7(8.24%) of patients in the Vancomycin arm, and 11 (11.83%) in the Daptomycin arm (P = 0.43). Gram-positive related infections and MRSA infections occurred in 1(1.18%)/0(0%) of Vancomycin patients and 9 (9.68%)/1 (1.08%) of Daptomycin patients, respectively (P < 0.02 and P = 1.00). Readmissions related to surgical site infections occurred in 4(4.71%) in the Vancomycin group and 11 (11.8%) in the Daptomycin group (P = 0.11). Patients undergoing operative exploration occurred in 5 (5.88%) in the Vancomycin group and 10 (10.75%) of the Daptomycin group (P = 0.17). Late infections were reported in 3 patients, 2 of which were in the combined Daptomycin group. Median hospital charges related to readmissions due to a surgical site infection was $50,823 in the combination Vancomycin arm and $110,920 in the combination Daptomycin group; however, no statistical significance was appreciated (P = 0.11). Vancomycin supplemental prophylaxis seems to reduce the incidence of Gram-positive infection compared with adding supplemental Daptomycin prophylaxis. The Incidence of MRSA-related surgical site infections is low with the addition of either anti-MRSA agents compared with historical incidence of MRSA-related infection.

Clinical outcome and patient satisfaction using biodegradable (NasoPore) and non-biodegradable packing, a double-blind, prospective, randomized study.

PubMed

Burduk, Pawel Krzysztof; Wierzchowska, Malgorzata; Grześkowiak, Blazej; Kaźmierczak, Wojciech; Wawrzyniak, Katarzyna

Nasal packing after endoscopic sinus surgery is used as a standard procedure. The optimum solution to minimize or eliminate all disadvantages of this procedure may be accomplished using biodegradable packs. The aim of this study was to compare patient satisfaction and clinical outcome associated with absorbable and non-absorbable packing after FESS. In total, 50 patients were included in a prospective, double-blind, randomized trial. One side was packed with polyurethane foam, while the opposite side was packed with gauze packing. On the 2nd, 10th, and 30th postoperative day, the patients were questioned with the aid of a visual analog scale. The standardized questionnaires for bleeding, nasal breathing, feeling of pressure, and headache were used. The presence of synechiae, infection, or granulation was noted and recorded with the video-endoscopy. A significant difference according to lower pressure was found in the NasoPore group compared to the controls on day ten after surgery. The NasoPore packing had lower scores with respect to postoperative nose blockage on the 2nd and 10th days. Mucosal healing was better for the NasoPore group, both at day ten and 30 compared with the control group. The overall patient comfort is higher when using NasoPore compared to non-resorbable traditional impregnated gauze packing. Intensive saline douches applied three to four times per day are mandatory after the operation to prevent synechiae formation and fluid resorption by the packing. Published by Elsevier Editora Ltda.

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.

Anatomical and functional evaluation of tympanoplasty using a transitory natural latex biomembrane implant from the rubber tree Hevea brasiliensis.

PubMed

Araujo, Marcos Miranda; Massuda, Eduardo Tanaka; Hyppolito, Miguel Angelo

2012-08-01

To compare the role of transitory latex and sylastic® implants in tympanoplasty on the closure of tympanic perforations. A randomized double-blind prospective study was conducted on 107 patients with chronic otitis media submitted to underlay tympanoplasty and divided at random into three groups: control with no transitory implant, latex membrane group, and sylastic® membrane group. Greater graft vascularization occurred in the latex membrane group (p<0.05). Good biocompatibility was obtained with the use of the latex and silicone implants, with no effect on the occurrence of infection, otorrhea or otorragy. The use of a transitory latex implant induced greater graft vascularization, with a biocompatible interaction with the tissue of the human tympanic membrane.

Substantiating In Vivo Magnetic Brain Tumor Targeting of Cationic Iron Oxide Nanocarriers via Adsorptive Surface Masking

PubMed Central

Chertok, Beata; David, Allan E.; Moffat, Bradford A.; Yang, Victor C.

2009-01-01

Cationic magnetic nanoparticles are attractive as potential vehicles for tumor drug delivery due to their favorable interactions with both the tumor milieu and the therapeutic cargo. However, systemic delivery of these nanoparticles to the tumor site is compromised by their rapid plasma clearance. We developed a simple method for in vivo protection of cationic nanocarriers, using non-covalent surface masking with a conjugate of low molecular weight heparin and polyethylene glycol. Surface masking resulted in an 11-fold increase in plasma AUC and a 2-fold increase in the magnetic capture of systemically injected nanoparticles in orthotopic rodent brain tumors. Overall, the described methodology could expand the prospective applications for cationic magnetic nanoparticles in magnetically-mediated gene/drug delivery. PMID:19782394

Analgesic Effect of Topical Sodium Diclofenac before Retinal Photocoagulation for Diabetic Retinopathy: A Randomized Double-masked Placebo-controlled Intraindividual Crossover Clinical Trial.

PubMed

Ramezani, Alireza; Entezari, Morteza; Shahbazi, Mohammad Mehdi; Semnani, Yosef; Nikkhah, Homayoun; Yaseri, Mehdi

2017-04-01

To evaluate the analgesic effect of topical sodium diclofenac 0.1% before retinal laser photocoagulation for diabetic retinopathy. Diabetic patients who were candidates for peripheral laser photocoagulation were included in a randomized, placebo-controlled, intraindividual, two-period, and crossover clinical trial. At the first session and based on randomization, one eye received topical sodium diclofenac 0.1% and the other eye received an artificial tear drop (as placebo) three times before laser treatment. At the second session, eyes were given the alternate drug. Patients scored their pain using visual analogue scale (max, 10 cm) at both sessions. Patients and the surgeon were blinded to the drops given. Difference of pain level was the main outcome measure. A total of 200 eyes of 100 patients were enrolled. Both treatments were matched regarding the applied laser. Pain sensation based on visual analogue scale was 5.6 ± 3.0 in the treated group and 5.5 ± 3.0 in the control group. The calculated treatment effect was 0.15 (95% confidence interval, -0.27 to 0.58; p = 0.486). The estimated period effect was 0.24 ( p = 0.530) and the carryover effect was not significant ( p = 0.283). Pretreatment with topical sodium diclofenac 0.1% does not have any analgesic effect during peripheral retinal laser photocoagulation in diabetic patients.

A Randomized Clinical Trial of Comparing Monophasic Monodensified and Biphasic Nonanimal Stabilized Hyaluronic Acid Dermal Fillers in Treatment of Asian Nasolabial Folds.

PubMed

Zhou, Shuang-Bai; Xie, Yun; Chiang, Cheng-An; Liu, Kai; Li, Qing-Feng

2016-09-01

Cross-linked hyaluronic acids (HAs) with varying characteristics and formulations are available. Despite the popularity of HA, limited studies compared the effectiveness of monophasic monodensified hyaluronic acid (MMHA) and biphasic nonanimal stabilized hyaluronic acid (BHA) products in correcting nasolabial folds (NLFs) in the Asian population. This double-blinded, randomized research aimed at evaluating the outcomes of MMHA and BHA products in treating Asian NLFs. Subjects aged between 18 and 65 years with moderate-to-severe NLFs were randomized to receive MMHA or BHA treatment. A touch-up treatment with the same product was performed at the 4-week follow-up, if needed. The effectiveness was evaluated for 24 weeks by masked investigators. All adverse events were recorded for safety evaluation. Twenty-five subjects in the MMHA Group and twenty-four subjects in the BHA Group finished 24-week follow-up. Results showed that subjects from both groups obtained satisfactory outcome in NLF correction. A lower amount of MMHA was required to achieve a similar result as that of BHA (p < .01). Both HA products maintained the effectiveness at the end of the 24-week follow-up. Both MMHA and BHA are effective for correcting NLF in Asian patients, producing satisfactory results. Monophasic monodensified hyaluronic acid provides similar satisfaction to BHA while requiring less injection volume.

Randomized, double-blind trial of CO2 versus air insufflation in children undergoing colonoscopy.

PubMed

Homan, Matjaž; Mahkovic, Dora; Orel, Rok; Mamula, Petar

2016-05-01

Studies in adults have shown that postprocedural abdominal pain is reduced with the use of carbon dioxide (CO(2)) instead of air for insufflation during colonoscopy. The aim of our study was to compare postprocedural abdominal pain and girth in children undergoing colonoscopy using CO(2) or air for insufflation. This was a prospective, randomized, double-blind study that included 76 consecutive pediatric patients undergoing colonoscopy for various indications. Patients were randomly assigned to either CO(2) or air insufflation. At 2, 4, and 24 hours after the examination, the patients' pain was assessed by using the 11-point numerical rating scale. The waist circumference was measured 10 minutes and 2 and 4 hours after colonoscopy. A significantly higher proportion of patients had no pain after colonoscopy in the CO(2) group compared with the air group (82 vs 37% at 2 hours and 95% vs. 63% at 4 hours, P < .001). Mean abdominal pain scores 2 and 4 hours after the procedure were statistically significantly lower in the CO(2) group compared with the control air group (0.5 vs 2.6 at 2 hours and 0.1 vs 1.2 at 4 hours, P < .001). There was no difference in waist circumference between the 2 groups at all time intervals. The results of this randomized trial show clear benefits of CO(2) insufflation for colonoscopy in reducing postprocedural discomfort. ( NCT02407639.). Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2015-02-01

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

Optical double-slit particle measuring system

DOEpatents

Tichenor, D.A.; Wang, J.C.F.; Hencken, K.R.

1982-03-25

A method for in situ measurement of particle size is described. The size information is obtained by scanning an image of the particle across a double-slit mask and observing the transmitted light. This method is useful when the particle size of primary interest is 3..mu..m and larger. The technique is well suited to applications in which the particles are non-spherical and have unknown refractive index. It is particularly well suited to high temperature environments in which the particle incandescence provides the light source.

Optical double-slit particle measuring system

DOEpatents

Hencken, Kenneth R.; Tichenor, Daniel A.; Wang, James C. F.

1984-01-01

A method for in situ measurement of particle size is described. The size information is obtained by scanning an image of the particle across a double-slit mask and observing the transmitted light. This method is useful when the particle size of primary interest is 3 .mu.m and larger. The technique is well suited to applications in which the particles are non-spherical and have unknown refractive index. It is particularly well suited to high temperature environments in which the particle incandescence provides the light source.

Clean induced feature CD shift of EUV mask

NASA Astrophysics Data System (ADS)

Nesládek, Pavel; Schedel, Thorsten; Bender, Markus

2016-05-01

EUV developed in the last decade to the most promising <7nm technology candidate. Defects are considered to be one of the most critical issues of the EUV mask. There are several contributors which make the EUV mask so different from the optical one. First one is the significantly more complicated mask stack consisting currently of 40 Mo/Si double layers, covered by Ru capping layer and TaN/TaO absorber/anti-reflective coating on top of the front face of the mask. Backside is in contrary to optical mask covered as well by conductive layer consisting of Cr or CrN. Second contributor is the fact that EUV mask is currently in contrary to optical mask not yet equipped with sealed pellicle, leading to much higher risk of mask contamination. Third reason is use of EUV mask in vacuum, possibly leading to deposition of vacuum contaminants on the EUV mask surface. Latter reason in combination with tight requirements on backside cleanliness lead to the request of frequent recleaning of the EUV mask, in order to sustain mask lifetime similar to that of optical mask. Mask cleaning process alters slightly the surface of any mask - binary COG mask, as well as phase shift mask of any type and naturally also of the EUV mask as well. In case of optical masks the changes are almost negligible, as the mask is exposed to max. 10-20 re-cleans within its life time. These modifications can be expressed in terms of different specified parameters, e.g. CD shift, phase/trans shift, change of the surface roughness etc. The CD shift, expressed as thinning (or exceptionally thickening) of the dark features on the mask is typically in order of magnitude 0.1nm per process run, which is completely acceptable for optical mask. Projected on the lifetime of EUV mask, assuming 100 clean process cycles, this will lead to CD change of about 10nm. For this reason the requirements for EUV mask cleaning are significantly tighter, << 0.1 nm per process run. This task will look even more challenging, when considering, that the tools for CD measurement at the EUV mask are identical as for optical mask. There is one aspect influencing the CD shift, which demands attention. The mask composition of the EUV mask is significantly different from the optical mask. More precisely there are 2 materials influencing the estimated CD in case of EUV mask, whereas there is one material only in case of optical masks, in first approximation. For optical masks, the CD changes can be attributed to modification of the absorber/ARC layer, as the quartz substrate can be hardly modified by the wet process. For EUV Masks chemical modification of the Ru capping layer - thinning, oxidization etc. are rather more probable and we need to take into account, how this effects can influence the CD measurement process. CD changes measured can be interpreted as either change in the feature size, or modification of the chemical nature of both absorber/ARC layer stack and the Ru capping layer. In our work we try to separate the effect of absorber and Ru/capping layer on the CD shift observed and propose independent way of estimation both parameters.

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.

Microfluidic approach for encapsulation via double emulsions.

PubMed

Wang, Wei; Zhang, Mao-Jie; Chu, Liang-Yin

2014-10-01

Double emulsions, with inner drops well protected by the outer shells, show great potential as compartmentalized systems to encapsulate multiple components for protecting actives, masking flavor, and targetedly delivering and controllably releasing drugs. Precise control of the encapsulation characteristics of each component is critical to achieve an optimal therapeutic efficacy for pharmaceutical applications. Such controllable encapsulation can be realized by using microfluidic approaches for producing monodisperse double emulsions with versatile and controllable structures as the encapsulation system. The size, number and composition of the emulsion drops can be accurately manipulated for optimizing the encapsulation of each component for pharmaceutical applications. In this review, we highlight the outstanding advantages of controllable microfluidic double emulsions for highly efficient and precisely controllable encapsulation. Copyright © 2014 Elsevier Ltd. All rights reserved.

An intensified dosing schedule of subcutaneous methotrexate in patients with moderate to severe plaque-type psoriasis (METOP): a 52 week, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.

PubMed

Warren, Richard B; Mrowietz, Ulrich; von Kiedrowski, Ralph; Niesmann, Johannes; Wilsmann-Theis, Dagmar; Ghoreschi, Kamran; Zschocke, Ina; Falk, Thomas M; Blödorn-Schlicht, Norbert; Reich, Kristian

2017-02-04

Methotrexate is one of the most commonly used systemic drugs for the treatment of moderate to severe psoriasis; however, high-quality evidence for its use is sparse and limited to use of oral dosing. We aimed to assess the effect of an intensified dosing schedule of subcutaneous methotrexate in patients with moderate to severe plaque-type psoriasis. We did this prospective, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial (METOP) at 16 sites in Germany, France, the Netherlands, and the UK. Eligible patients were aged 18 years or older, had a diagnosis of chronic plaque psoriasis for at least 6 months before baseline, had currently moderate to severe disease, and were methotrexate treatment-naive. Participants were randomly assigned (3:1), via a computer-generated random number sequence integrated into an electronic data capture system, to receive either methotrexate at a starting dose of 17·5 mg/week or placebo for the first 16 weeks, followed by methotrexate treatment of all patients up to 52 weeks (methotrexate-methotrexate vs placebo-methotrexate groups). Dose escalation to 22·5 mg/week was allowed after 8 weeks of methotrexate treatment if patients had not achieved at least a 50% reduction in baseline Psoriasis Area and Severity Index score (PASI), with corresponding volume increases in placebo injections. Treatment was combined with folic acid 5 mg/week. Group allocation was concealed from participants and investigators from the time of randomisation until an interim database lock at week 16, and was open label from week 16 onwards, with no masking of participants or investigators. The primary efficacy endpoint was a 75% reduction in PASI score (PASI 75) from baseline to week 16. We did analysis by modified intention to treat, with non-responder imputation. This study is registered with EudraCT, number 2012-002716-10. Between Feb 22, 2013, and May 13, 2015, we randomly assigned 120 patients to receive methotrexate (n=91) or placebo (n=29). At week 16, a PASI 75 response was achieved in 37 (41%) patients in the methotrexate group compared with three (10%) patients in the placebo group (relative risk 3·93, 95% CI 1·31-11·81; p=0·0026). Subcutaneous methotrexate was generally well tolerated; no patients died or had serious infections, malignancies, or major adverse cardiovascular events. Serious adverse events were recorded in three (3%) patients who received methotrexate for the full 52 week treatment period. Our findings show a favourable 52 week risk-benefit profile of subcutaneous methotrexate in patients with psoriasis. The route of administration and the intensified dosing schedule should be considered when methotrexate is used in this patient group. Medac. Copyright © 2017 Elsevier Ltd. All rights reserved.

A Randomized, Double-Masked, Placebo-Controlled Clinical Trial of Two Forms of Omega-3 Supplements for Treating Dry Eye Disease.

PubMed

Deinema, Laura A; Vingrys, Algis J; Wong, Chinn Yi; Jackson, David C; Chinnery, Holly R; Downie, Laura E

2017-01-01

To assess the efficacy of 2 forms of oral long-chain omega-3 (ω-3) essential fatty acid (EFA) supplements, phospholipid (krill oil) and triacylglyceride (fish oil), for treating dry eye disease (DED). Randomized, double-masked, placebo-controlled clinical trial. This study was conducted at a single site and involved 60 participants with mild to moderate DED who were randomized (1:1:1) to 1 of 3 groups: placebo (olive oil), krill oil, or fish oil supplements. Participants received 1 of the 3 interventions: placebo (olive oil 1500 mg/day), krill oil (945 mg/day eicosapentaenoic acid [EPA], + 510 mg/day docosahexaenoic acid [DHA]), or fish oil (1000 mg/day EPA + 500 mg/day DHA) for 90 days, with monthly study visits. Primary outcome measures were mean change in (1) tear osmolarity and (2) DED symptoms (Ocular Surface Disease Index [OSDI] score) between days 1 and 90. Secondary outcomes included mean change in key clinical signs (tear stability, tear production, ocular surface staining, bulbar and limbal redness, tear volume, anterior blepharitis, meibomian gland capping) and tear inflammatory cytokine levels. In total, 54 participants completed the study. At day 90, tear osmolarity was reduced from baseline with both krill oil (mean ± standard error of the mean: -18.6±4.5 mOsmol/l; n = 18; P < 0.001) and fish oil (-19.8±3.9 mOsmol/l; n = 19; P < 0.001) supplements, compared with placebo (-1.5±4.4 mOsmol/l; n = 17). OSDI score was significantly reduced at day 90 relative to baseline in the krill oil group only, compared with placebo (-18.6±2.4 vs. -10.5±3.3; P = 0.02). At day 90, there were also relative improvements in tear breakup time and ocular bulbar redness, compared with placebo, for both forms of ω-3 EFAs. Basal tear levels of the proinflammatory cytokine interleukin 17A were significantly reduced in the krill oil group, compared with placebo, at day 90 (-27.1±10.9 vs. 46.5±30.4 pg/ml; P = 0.02). A moderate daily dose of both forms of long-chain ω-3 EFAs, for 3 months, resulted in reduced tear osmolarity and increased tear stability in people with DED. Omega-3 EFAs in a predominantly phospholipid form (krill oil) may confer additional therapeutic benefit, with improvements in DED symptoms and lower basal tear levels of interleukin 17A, relative to placebo. Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Fluoroscopic Placement of Double-Pigtail Ureteral Stents

PubMed Central

Chen, Gregory L.

2001-01-01

Purpose: Double-pigtail ureteral stent is placed cystoscopically after ureteroscopy. We describe a technique for fluoroscopic placement of ureteral stents and demonstrate its use in a non-randomized prospective study. Materials and methods: Double-pigtail stents were placed either fluoroscopically or cystoscopically in 121 consecutive patients. In the fluoroscopic method, the stent was placed over a guide wire using a stent pusher without the use of cystoscopy. Conversely, stents were placed through the working channel of the cystoscope under vision. The procedure, stent length, width, type, method, ureteral dilation, and use of a retrieval string were noted. Results: A wide range of stent sizes were used. The success with fluoroscopic placement of double-pigtail ureteral stents was 100% (89 of 89 cases). No stents migrated or required replacement. Stents were placed after ureteroscopic laser lithotripsy (53/89) and ureteroscopic tumor treatment (22/89). Cystoscopic visualization was used in 32 additional procedures requiring precise control (15 ureteral strictures and nine retrograde endopyelotomy). Conclusions: The fluoroscopic placement of ureteral stents is a safe and simple technique with a very high success rate. We have used cystoscopic placement only after incisional procedures such as retrograde endopyelotomy, stricture or ureterotomy. PMID:18493562

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

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

Feasibility of aerosol drug delivery to sleeping infants: a prospective observational study.

PubMed

Amirav, Israel; Newhouse, Michael T; Luder, Anthony; Halamish, Asaf; Omar, Hamza; Gorenberg, Miguel

2014-03-26

Delivery of inhaled medications to infants is usually very demanding and is often associated with crying and mask rejection. It has been suggested that aerosol administration during sleep may be an attractive alternative. Previous studies in sleeping children were disappointing as most of the children awoke and rejected the treatment. The SootherMask (SM) is a new, gentle and innovative approach for delivering inhaled medication to infants and toddlers. The present pilot study describes the feasibility of administering inhaled medications during sleep using the SM. Prospective observational study. Out patients. 13 sleeping infants with recurrent wheezing who regularly used pacifiers and were <12 months old. Participants inhaled technetium99mDTPA-labelled normal saline aerosol delivered via a Respimat Soft Mist Inhaler (SMI) (Boehringer-Ingelheim, Germany) and SM + InspiraChamber (IC; InspiRx Inc, New Jersey, USA). The two major outcomes were the acceptability of the treatment and the lung deposition (per cent of emitted dose). All infants who fulfilled the inclusion criteria successfully received the SM treatment during sleep without difficulty. Mean lung deposition (±SD) averaged 1.6±0.5% in the right lung. This study demonstrated that the combination of Respimat, IC and SM was able to administer aerosol therapy to all the sleeping infants who were regular pacifier users with good lung deposition. Administration of aerosols during sleep is advantageous since all the sleeping children accepted the mask and ensuing aerosol therapy under these conditions, in contrast to previous studies in which there was frequent mask rejection using currently available devices. NCT01120938.

A mathematical framework to quantify the masking effect associated with the confidence intervals of measures of disproportionality

PubMed Central

Maignen, François; Hauben, Manfred; Dogné, Jean-Michel

2017-01-01

Background: The lower bound of the 95% confidence interval of measures of disproportionality (Lower95CI) is widely used in signal detection. Masking is a statistical issue by which true signals of disproportionate reporting are hidden by the presence of other medicines. The primary objective of our study is to develop and validate a mathematical framework for assessing the masking effect of Lower95CI. Methods: We have developed our new algorithm based on the masking ratio (MR) developed for the measures of disproportionality. A MR for the Lower95CI (MRCI) is proposed. A simulation study to validate this algorithm was also conducted. Results: We have established the existence of a very close mathematical relation between MR and MRCI. For a given drug–event pair, the same product will be responsible for the highest masking effect with the measure of disproportionality and its Lower95CI. The extent of masking is likely to be very similar across the two methods. An important proportion of identical drug–event associations affected by the presence of an important masking effect is revealed by the unmasking exercise, whether the proportional reporting ratio (PRR) or its confidence interval are used. Conclusion: The detection of the masking effect of Lower95CI can be automated. The real benefits of this unmasking in terms of new true-positive signals (rate of true-positive/false-positive) or time gained by the revealing of signals using this method have not been fully assessed. These benefits should be demonstrated in the context of prospective studies. PMID:28845231

Masking Treatment and its Effect on Tinnitus Parameters.

PubMed

Aytac, Ismail; Baysal, Elif; Gulsen, Secaattin; Tumuklu, Koray; Durucu, Cengiz; Mumbuc, Lütfi Semih; Kanlikama, MUzaffer

2017-12-01

Tinnitus is described as the perception of sound without any external acoustic stimulation. Any pathology of auditory pathways or any system of the human body may result with tinnitus. The pathophysiology of tinnitus accompanying the disorders of auditory system is not fully understood and there is not any particular effective treatment method has been specified. Tinnitus masking therapy has been reported as an effective treatment modality in the treatment of tinnitus. In this study, the results of tinnitus masking treatment on the parameters were evaluated prospectively. Patients with normal physical examination was enrolled in the study. Blood tests (complete blood count, biochemical analysis of lipid profile, and thyroid hormones), pure tone audiometry, tympanometric measurement of the middle ear pressure and stapedial reflexes were performed, Sixty six patients with normal results of blood tests and normal hearing thresholds with type A tympanogram were included. Tinnitus sufferers questionnaires (socio-demographics, clinical information, Tinnitus Handicap Inventory (THI), Beck Depression Inventory (BDI) was filled, audiological tests were performed, tinnitus parameters (frequency, intensity, minimal masking levels, residual inhibition) were measured. After four weeks of the treatment the questionnaires were repeated. Masking treatment for tinnitus patients resulted with significant decrease in Tinnitus Handicap Inventory and VAS scores. After four weeks of the masking treatment the questionnaire was repeated. Twenty patients did not respond to treatment. Masking therapy is one of the most effective methods of treatment for tinnitus patients. Masking therapy, that is not invasive and cost-effective has an important place in the treatment of tinnitus. Especially in a short time provides a significant reduction in tinnitus parameters.

Homeopathic Individualized Q-Potencies versus Fluoxetine for Moderate to Severe Depression: Double-Blind, Randomized Non-Inferiority Trial

PubMed Central

Adler, U. C.; Paiva, N. M. P.; Cesar, A. T.; Adler, M. S.; Molina, A.; Padula, A. E.; Calil, H. M.

2011-01-01

Homeopathy is a complementary and integrative medicine used in depression, The aim of this study is to investigate the non-inferiority and tolerability of individualized homeopathic medicines [Quinquagintamillesmial (Q-potencies)] in acute depression, using fluoxetine as active control. Ninety-one outpatients with moderate to severe depression were assigned to receive an individualized homeopathic medicine or fluoxetine 20 mg day−1 (up to 40 mg day−1) in a prospective, randomized, double-blind double-dummy 8-week, single-center trial. Primary efficacy measure was the analysis of the mean change in the Montgomery & Åsberg Depression Rating Scale (MADRS) depression scores, using a non-inferiority test with margin of 1.45. Secondary efficacy outcomes were response and remission rates. Tolerability was assessed with the side effect rating scale of the Scandinavian Society of Psychopharmacology. Mean MADRS scores differences were not significant at the 4th (P = .654) and 8th weeks (P = .965) of treatment. Non-inferiority of homeopathy was indicated because the upper limit of the confidence interval (CI) for mean difference in MADRS change was less than the non-inferiority margin: mean differences (homeopathy-fluoxetine) were −3.04 (95% CI −6.95, 0.86) and −2.4 (95% CI −6.05, 0.77) at 4th and 8th week, respectively. There were no significant differences between the percentages of response or remission rates in both groups. Tolerability: there were no significant differences between the side effects rates, although a higher percentage of patients treated with fluoxetine reported troublesome side effects and there was a trend toward greater treatment interruption for adverse effects in the fluoxetine group. This study illustrates the feasibility of randomized controlled double-blind trials of homeopathy in depression and indicates the non-inferiority of individualized homeopathic Q-potencies as compared to fluoxetine in acute treatment of outpatients with moderate to severe depression. PMID:19687192

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

Prospective double blind randomized placebo-controlled clinical trial of the pectoral nerves (Pecs) block type II.

PubMed

Versyck, Barbara; van Geffen, Geert-Jan; Van Houwe, Patrick

2017-08-01

The aim of this clinical trial was to test the hypothesis whether adding the pectoral nerves (Pecs) block type II to the anesthetic procedure reduces opioid consumption during and after breast surgery. A prospective randomized double blind placebo-controlled study. A secondary hospital. 140 breast cancer stage 1-3 patients undergoing mastectomy or tumorectomy with sentinel node or axillary node dissection. Patients were randomized to receive either a Pecs block with levobupivacaine 0.25% (n=70) or placebo block with saline (n=70). The pain levels were evaluated by Numeric Rating Scale (NRS) pain scores at 15-minute intervals during the post anesthesia care unit stay time (PACU), at 2-hour intervals for the first 24h on the ward and at 4-hour intervals for the next 24h. Intraoperative and postoperative opioid consumption were recorded during the full stay. Patient satisfaction was evaluated upon discharge using a 10-point scale. Intraoperative sufentanil requirements were comparable for the Pecs and placebo group (8.0±3.5μg and 7.8±3.0μg, P=0.730). Patients in the Pecs group experienced significantly less pain than patients in the control group (P=0.048) during their PACU stay. Furthermore, patients in the Pecs group required significant less postoperative opioids (9.16±10.15mg and 14.97±14.38mg morphine equivalent, P=0.037) and required significant fewer postsurgical opioid administration interventions than patients in the control group (P=0.045). Both patient-groups were very satisfied about their management (9.6±0.6 and 9.1±1.8 on a 10-point scale, P=0.211). The Pecs block reduces postsurgical opioid consumption during the PACU stay time for patients undergoing breast surgery. Copyright © 2017 Elsevier Inc. All rights reserved.

Comparison of Nerve Stimulation-guided Axillary Brachial Plexus Block, Single Injection versus Four Injections: A Prospective Randomized Double-blind Study.

PubMed

Badiger, Santoshi V; Desai, Sameer N

2017-01-01

A variety of techniques have been described for the axillary block using nerve stimulator, either with single injection, two, three, or four separate injections. Identification of all the four nerves is more difficult and time-consuming than other methods. Aim of the present study is to compare success rate, onset, and duration of sensory and motor anesthesia of axillary block using nerve stimulator, either with single injection after identification of any one of the four nerves or four separate injections following identification of each of nerve. Prospective, randomized, double-blind study. Patients undergoing forearm and hand surgeries under axillary block. One hundred patients, aged 18-75 years, were randomly allocated into two groups of 50 each. Axillary block was performed under the guidance of nerve stimulator with a mixture of 18 ml of 1.5% lignocaine and 18 ml of 0.5% bupivacaine. In the first group ( n = 50), all 36 ml of local anesthetic was injected after the identification of motor response to any one of the nerves and in Group 2, all the four nerves were identified by the motor response, and 9 ml of local anesthetic was injected at each of the nerves. The success rate of the block, onset, and duration of sensory and motor block was assessed. Categorical variables were compared using the Chi-square test, and continuous variables were compared using independent t -test. The success rate of the block with four injection technique was higher compared to single-injection technique (84% vs. 56%, P = 0.02). Four injection groups had a faster onset of sensory and motor block and prolonged duration of analgesia compared to single-injection group ( P < 0.001). There were no significant differences in the incidence of accidental arterial puncture and hemodynamic parameter between the groups. Identification of all the four nerves produced higher success rate and better quality of the block when compared to single-injection technique.

Plasma-Lyte 148 vs. Hartmann's solution for cardiopulmonary bypass pump prime: a prospective double-blind randomized trial.

PubMed

Weinberg, Laurence; Chiam, Elizabeth; Hooper, James; Liskaser, Frank; Hawkins, Angela Kim; Massie, Denise; Ellis, Andrew; Tan, Chong O; Story, David; Bellomo, Rinaldo

2018-05-01

The mechanisms of acid-base changes during cardiopulmonary bypass (CPB) remain unclear. We tested the hypothesis that, when used as CPB pump prime solutions, Plasma-Lyte 148 (PL) and Hartmann's solution (HS) have differential mechanisms of action in their contribution to acid-base changes. We performed a prospective, double-blind, randomized trial in adult patients undergoing elective cardiac surgery with CPB. Participants received a CPB prime solution of 2000 mL, with either PL or HS. The primary endpoint was the standard base excess (SBE) value measured at 60 minutes after full CPB flows (SBE60min). Secondary outcomes included changes in SBE, pH, chloride, sodium, lactate, gluconate, acetate, strong ion difference and strong ion gap at two (T2min), five (T5min), ten (T10min), thirty (T30min) and sixty (T60min) minutes on CPB. The primary outcome was measured using a two-tailed Welch's t-test. Repeated measures ANOVA was used to test for differences between time points. Twenty-five participants were randomized to PL and 25 to HS. Baseline characteristics, EURO and APACHE scores, biochemistry, hematology and volumes of cardioplegia were similar. Mean (SD) SBE at T60min was -1.3 (1.4) in the PL group and -0.1 (2.7) in the HS group; p=0.55. No significant differences in SBE between the groups was observed during the first 60 minutes (p=0.48). During CPB, there was hyperacetatemia and hypergluconatemia in the PL group and hyperlactatemia and hyperchloremia in the HS group. No significant difference between the groups in plasma bicarbonate levels and total weak acid levels were found. Complications and intensive care unit and hospital length of stays were similar. During CPB, PL and HS did not cause a significant metabolic acidosis. There was hyperacetatemia and hypergluconatemia with PL and hyperchloremia and hyperlactatemia with HS. These physiochemical effects appear clinically innocuous.

Acute rejection characteristics from a prospective, randomized, double-blind, placebo-controlled multicenter trial of early corticosteroid withdrawal.

PubMed

Gaber, A Osama; Moore, Linda W; Alloway, Rita R; Woodle, E Steve; Pirsch, John; Shihab, Fuad; Henning, Alice; Fitzsimmons, William; Holman, John; Reisfield, Robin; First, M Roy

2013-02-27

This report characterizes acute rejection and rejection outcomes in subjects randomized to continuous corticosteroid therapy (CCS) or early corticosteroid withdrawal (CSWD; 7 days after transplantation) in the Astellas Blinded CSWD Trial. The Astellas Blinded CSWD Trial was a 5-year, prospective, multicenter, randomized, double-blind trial of early CCS withdrawal in 386 kidney transplant recipients (195 CCS and 191 CSWD). Tacrolimus and mycophenolate mofetil were required as well as either rabbit antithymocyte globulin or interleukin-2 receptor antibody induction. Biopsy-confirmed acute rejection (BCAR) was grade 1A or higher by Banff criteria. This report also provides borderline changes (BL) that did not meet Banff grade 1A included with BCAR (BCAR+BL). BCAR+BL was 25 (12.8%) in CCS group and 42 (22.0%) in CSWD group (P=0.022). Early BCAR+BL (first 90 days after transplantation) was less frequent in CCS (n=5 [2.6%]) than in CSWD (n=22 [11.5%]; P<0.001). Among non-African-American subjects, early BCAR+BL occurred more often in CSWD (n=20 [12.7%]) versus CCS (n=2 [1.3%]; P<0.001). Late acute rejection (>2 years) occurred more often in African-American subjects in CCS (n=5 [13.9%]) than in CSWD (n=0; P=0.056). Risk factors were CSWD (hazard ratio [HR], 4.72; P<0.002) and human leukocyte antigen mismatch (HR, 1.48; P<0.005) for early BCAR+BL and CSWD (HR, 1.9; P<0.02), human leukocyte antigen mismatch (HR, 1.2; P<0.01), and age (HR, 0.97; P<0.002) for 5-year rejection. The HR for graft loss associated with BCAR+BL was 8.8. BCAR+BL may occur more frequently during the early period after transplantation under an early CSWD regimen with tacrolimus plus induction compared with CCS, particularly among non-African-Americans.

Lumbar Intradiskal Platelet-Rich Plasma (PRP) Injections: A Prospective, Double-Blind, Randomized Controlled Study.

PubMed

Tuakli-Wosornu, Yetsa A; Terry, Alon; Boachie-Adjei, Kwadwo; Harrison, Julian R; Gribbin, Caitlin K; LaSalle, Elizabeth E; Nguyen, Joseph T; Solomon, Jennifer L; Lutz, Gregory E

2016-01-01

To determine whether single injections of autologous platelet-rich plasma (PRP) into symptomatic degenerative intervertebral disks will improve participant-reported pain and function. Prospective, double-blind, randomized controlled study. Outpatient physiatric spine practice. Adults with chronic (≥6 months), moderate-to-severe lumbar diskogenic pain that was unresponsive to conservative treatment. Participants were randomized to receive intradiskal PRP or contrast agent after provocative diskography. Data on pain, physical function, and participant satisfaction were collected at 1 week, 4 weeks, 8 weeks, 6 months, and 1 year. Participants in the control group who did not improve at 8 weeks were offered the option to receive PRP and subsequently followed. Functional Rating Index (FRI), Numeric Rating Scale (NRS) for pain, the pain and physical function domains of the 36-item Short Form Health Survey, and the modified North American Spine Society (NASS) Outcome Questionnaire were used. Forty-seven participants (29 in the treatment group, 18 in the control group) were analyzed by an independent observer with a 92% follow-up rate. Over 8 weeks of follow-up, there were statistically significant improvements in participants who received intradiskal PRP with regards to pain (NRS Best Pain) (P = .02), function (FRI) (P = .03), and patient satisfaction (NASS Outcome Questionnaire) (P = .01) compared with controls. No adverse events of disk space infection, neurologic injury, or progressive herniation were reported following the injection of PRP. Participants who received intradiskal PRP showed significant improvements in FRI, NRS Best Pain, and NASS patient satisfaction scores over 8 weeks compared with controls. Those who received PRP maintained significant improvements in FRI scores through at least 1 year of follow-up. Although these results are promising, further studies are needed to define the subset of participants most likely to respond to biologic intradiskal treatment and the ideal cellular characteristics of the intradiskal PRP injectate. Copyright © 2016 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

Effectiveness of Liposomal Bupivacaine in Colorectal Surgery: A Pragmatic Nonsponsored Prospective Randomized Double Blinded Trial in a Community Hospital.

PubMed

Knudson, Rachel A; Dunlavy, Paul W; Franko, Jan; Raman, Shankar R; Kraemer, Soren R

2016-09-01

Prior industry conducted studies have shown that long acting liposomal bupivacaine injection improves pain control postoperatively. To evaluate whether liposomal bupivacaine reduced the use of postoperative opioid (http://links.lww.com/DCR/A253) pain medication as compared to standard bupivacaine following colorectal surgery. A double blinded, prospective, randomized controlled trial comparing liposomal bupivacaine versus standard bupivacaine in patients undergoing elective colon resection. Community hospital with general surgery residency program with all cases performed by colorectal surgeons. Fifty-seven patients were randomized and reported as intention-to-treat analysis with 6 protocol violations. Sensitivity analysis excluding these 6 patients demonstrated no change in study results or conclusion. Mean age was 67 ± 2 years and 56% were male. There were 36 patients who underwent minimally invasive surgery, and 21 patients had an open colon resection. Experimental arm received liposomal bupivacaine while control arm received standard bupivacaine. Primary outcome measure was intravenous hydromorphone equivalent used via PCA during first 48 hours after operation. There was no significant difference between the two groups in the amount of opioid used orally or intravenously in the postoperative period. The primary outcome measure was PCA hydromorphone consumption during first two postoperative days after operation (hydromorphone equivalent use in standard bupivacaine group 11.3 ± 8.9 mg versus 13.3 ± 11.9 mg in liposomal bupivacaine group, p = 0.58 Mann-Whitney test). Small pragmatic trials typically remain underpowered for secondary analyses. A larger study could help to further delineate other outcomes that are impacted by postoperative pain. Liposomal bupivacaine did not change the amount of opioid used postoperatively. Based on our study, liposomal bupivacaine does not provide any added benefit over conventional bupivacaine after colon resection. (ClinicalTrials.gov: NCT02052557).

Does the combination of 3% mepivacaine plain plus 2% lidocaine with epinephrine improve anesthesia and reduce the pain of anesthetic injection for the inferior alveolar nerve block? A prospective, randomized, double-blind study.

PubMed

Lammers, Emily; Nusstein, John; Reader, Al; Drum, Melissa; Beck, Mike; Fowler, Sara

2014-09-01

In theory, using 3% mepivacaine initially for an inferior alveolar nerve (IAN) block would decrease the pain of injection, provide faster onset, and increase anesthetic success. The purpose of this prospective, randomized, double-blind study was to compare the degree of pulpal anesthesia obtained with a combination of 3% mepivacaine/2% lidocaine (1:100,000 epinephrine) versus a combination of 2% lidocaine (1:100,000 epinephrine)/2% lidocaine (1:100,000 epinephrine) in IAN blocks. Injection pain was also studied. One hundred asymptomatic subjects were randomly given a combination of a 1-cartridge volume of 3% mepivacaine plus a 1-cartridge volume of 2% lidocaine with 1:100,000 epinephrine and a combination of a 1-cartridge volume of 2% lidocaine with 1:100,000 epinephrine plus a 1-cartridge volume of 2% lidocaine with 1:100,000 epinephrine for the IAN block at 2 separate appointments. Subjects rated the pain of injection. The molars, premolars, and incisors were tested with an electric pulp tester in 4-minute cycles for 60 minutes. Anesthetic success was defined as the subject achieving 2 consecutive 80 readings within 15 minutes after completion of the IAN blocks and sustaining the 80 reading for 60 minutes. Success was not significantly different (P > .05) between the 2 combinations. No statistical differences in injection pain or onset times were found. The combination of 3% mepivacaine plus 2% lidocaine with 1:100,000 epinephrine was equivalent to the combination of 2 cartridges of 2% lidocaine with 1:100,000 epinephrine in terms of injection pain, onset time, and pulpal anesthetic success for the IAN block. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Efficacy of Ketorolac Buccal Infiltrations and Inferior Alveolar Nerve Blocks in Patients with Irreversible Pulpitis: A Prospective, Double-blind, Randomized Clinical Trial.

PubMed

Akhlaghi, Nahid Mohammadzadeh; Hormozi, Behnoush; Abbott, Paul V; Khalilak, Zohreh

2016-05-01

The purpose of this prospective, randomized, double-blind, placebo-controlled study was to determine whether ketorolac buccal infiltrations (BIs) helped to improve the success of inferior alveolar nerve blocks (IANBs) in patients with acute irreversible pulpitis (AIP). Forty adult volunteers with AIP in a mandibular molar were included in this study. Patients were instructed to evaluate their pain by using a Heft-Parker visual analog scale. They were randomly divided into 2 groups (n = 20). All patients received standard IANB injection and after that a BI of 4% articaine with 1:100,000 epinephrine. After 5 minutes, 20 patients received a BI of 30 mg/mL ketorolac, and the other received a BI of normal saline (control group). Endodontic access cavity preparation (ACP) was initiated 15 minutes after the IANB when the patient reported lip numbness and had 2 electric pulp tests with no responses. The patient's pain during caries and dentin removal, ACP, and canal length measurements (CLM) was recorded by using Heft-Parker visual analog scale. Successful anesthesia was defined as no or mild pain during any of these steps, without the need for additional injection. Data were statistically analyzed by using Mann-Whitney U and χ(2) tests. Successful anesthesia after an IANB plus BI of articaine was obtained in 15% of patients in the control group at the end of CLM. Adding BI of ketorolac significantly increased the success rate to 40% (P < .05). Patient's pain during ACP and CLM was significantly lower in the ketorolac group (P < .05). Ketorolac BI can increase the success rate of anesthesia after IANB and BI with articaine in patients with AIP. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Effects of preoperative aspirin in coronary artery bypass grafting: a double-blind, placebo-controlled, randomized trial.

PubMed

Deja, Marek A; Kargul, Tomasz; Domaradzki, Wojciech; Stącel, Tomasz; Mazur, Witold; Wojakowski, Wojciech; Gocoł, Radosław; Gaszewska-Żurek, Ewa; Żurek, Paweł; Pytel, Agata; Woś, Stanisław

2012-07-01

This trial was undertaken to determine the safety and efficacy of preoperative aspirin administration in a contemporary cardiac surgical practice setting. This randomized, double-blind, parallel-group, single-center trial involved patients with stable coronary artery disease who were assigned to receive either 300 mg of aspirin or placebo the night before coronary bypass surgery. Using a random digit table, patients were allocated to receive the tablet from 1 of the 40 coded bottles containing either aspirin or placebo. Patients, surgeons, anesthetists, and investigators were all masked to treatment allocation. The primary safety end points were as follows: more than 750 mL of bleeding during the first postoperative 12 hours and more than 1000 mL of total discharge from the chest drains. The secondary efficacy end point was a composite of cardiovascular death, myocardial infarction, or repeat revascularization. A total of 390 patients were allocated to aspirin (387 analyzed) and 399 to placebo (396 analyzed). The follow-up median was 53 months. Fifty-four placebo recipients and 86 aspirin recipients bled more than 750 mL in the first 12 hours (odds ratio [OR], 1.81; 95% confidence interval [CI], 1.25-2.63), while total chest drain discharge was above 1000 mL in 96 placebo and 131 aspirin recipients (OR, 1.60; 95% CI, 1.17-2.18). Preoperative aspirin decreased the long-term hazard of nonfatal coronary event (infarction or repeat revascularization)-hazard ratio (HR), 0.58 (95% CI, 0.33-0.99)--and tended to decrease the hazard of a major cardiac event (cardiovascular death, infarction, or repeat revascularization--HR, 0.65 [95% CI, 0.41-1.03]). Performing coronary grafts on aspirin is associated with increased postoperative bleeding but may decrease the long-term hazard of coronary events. Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

Tribulus terrestris versus placebo in the treatment of erectile dysfunction: A prospective, randomized, double blind study.

PubMed

Santos, C A; Reis, L O; Destro-Saade, R; Luiza-Reis, A; Fregonesi, A

2014-05-01

To evaluate the possible effects of Tribulus terrestris herbal medicine in the erectile dysfunction treatment and to quantify its potential impact on serum testosterone levels. Prospective, randomized, double-blind and placebo-controlled study including thirty healthy men selected from 100 patients who presented themselves spontaneously complaining of erectile dysfunction, ≥ 40 years of age, nonsmokers, not undergoing treatment for prostate cancer or erectile dysfunction, no dyslipidemia, no phosphodiesterase inhibitor use, no hormonal manipulation and, if present hypertension and/or diabetes mellitus should be controlled. International Index of Erectile Function (IIEF-5) and serum testosterone were obtained before randomization and after 30 days of study. Patients were randomized into two groups of fifteen subjects each. The study group received 800 mg of Tribulus terrestris, divided into two doses per day for thirty days and the control group received placebo administered in the same way. The groups were statistically equivalent in all aspects evaluated. The mean (SD) age was 60 (9.4) and 62.9 (7.9), P = .36 for intervention and placebo groups, respectively. Before treatment, the intervention group showed mean IIEF-5 of 13.2 (5-21) and mean total testosterone 417.1 ng/dl (270.7-548.4 ng/dl); the placebo group showed mean IIEF-5 of 11.6 (6-21) and mean total testosterone 442.7 ng/dl (301-609.1 ng/dl). After treatment, the intervention group showed mean IIEF-5 of 15.3 (5-21) and mean total testosterone 409.3 ng/dl (216.9-760.8 ng/dl); the placebo group showed mean IIEF-5 of 13.7 (6-21) and mean total testosterone 466.3 ng/dl (264.3-934.3 ng/dl). The time factor caused statistically significant changes in both groups for IIEF-5 only (P = .0004), however, there was no difference between the two groups (P = .7914). At the dose and interval studied, Tribulus terrestris was not more effective than placebo on improving symptoms of erectile dysfunction or serum total testosterone. Copyright © 2013 AEU. Published by Elsevier Espana. All rights reserved.

A randomized trial of the efficacy and safety of sequential intravenous/oral moxifloxacin monotherapy versus intravenous piperacillin/tazobactam followed by oral amoxicillin/clavulanate for complicated skin and skin structure infections.

PubMed

Gyssens, Inge C; Dryden, Matthew; Kujath, Peter; Nathwani, Dilip; Schaper, Nicolaas; Hampel, Barbara; Reimnitz, Peter; Alder, Jeff; Arvis, Pierre

2011-11-01

The primary aim of the RELIEF study was to evaluate the efficacy and safety of two sequential intravenous (iv)/oral regimens: moxifloxacin iv/oral versus piperacillin/tazobactam (TZP) iv followed by oral amoxicillin/clavulanate (AMC). The study had a prospective, randomized, double-dummy, double-blind, multicentre design. Patients ≥18 years were prospectively stratified according to complicated skin and skin structure infection (cSSSI) subtype/diagnosis (major abscess, diabetic foot infection, wound infection or infected ischaemic ulcer), surgical intervention and severity of illness. Diagnoses and disease severity were based on predetermined criteria, documented by repeated photographs, and confirmed by an independent data review committee. Patients were randomized to receive either 400 mg of moxifloxacin iv once daily followed by 400 mg of moxifloxacin orally once daily or 4.0/0.5 g of TZP iv thrice daily followed by 875/125 mg of AMC orally twice daily for 7-21 days. The primary efficacy variable was clinical response at test of cure (TOC) for the per-protocol (PP) population. Clinical efficacy was assessed by the data review committee based on repeated photographs and case descriptions. Clinical trials registry number: NCT 00402727. A total of 813 patients were randomized. Clinical success rates at TOC were similar for moxifloxacin and TZP-AMC in the PP [320/361 (88.6%) versus 275/307 (89.6%), respectively; P = 0.758] and intent-to-treat (ITT) [350/426 (82.2%) versus 305/377 (80.9%), respectively; P = 0.632] populations. Thus, moxifloxacin was non-inferior to TZP-AMC. Bacteriological success rates were high in both treatment arms [moxifloxacin: 432/497 (86.9%) versus TZP-AMC: 370/429 (86.2%), microbiologically valid (MBV) population]. Moxifloxacin was non-inferior to TZP-AMC at TOC in both the MBV and the ITT populations. Both treatments were well tolerated. Once-daily iv/oral moxifloxacin monotherapy was clinically and bacteriologically non-inferior to iv TZP thrice daily followed by oral AMC twice daily in patients with cSSSIs.

A randomized trial of the efficacy and safety of sequential intravenous/oral moxifloxacin monotherapy versus intravenous piperacillin/tazobactam followed by oral amoxicillin/clavulanate for complicated skin and skin structure infections

PubMed Central

Gyssens, Inge C.; Dryden, Matthew; Kujath, Peter; Nathwani, Dilip; Schaper, Nicolaas; Hampel, Barbara; Reimnitz, Peter; Alder, Jeff; Arvis, Pierre

2011-01-01

Objectives The primary aim of the RELIEF study was to evaluate the efficacy and safety of two sequential intravenous (iv)/oral regimens: moxifloxacin iv/oral versus piperacillin/tazobactam (TZP) iv followed by oral amoxicillin/clavulanate (AMC). Patients and methods The study had a prospective, randomized, double-dummy, double-blind, multicentre design. Patients ≥18 years were prospectively stratified according to complicated skin and skin structure infection (cSSSI) subtype/diagnosis (major abscess, diabetic foot infection, wound infection or infected ischaemic ulcer), surgical intervention and severity of illness. Diagnoses and disease severity were based on predetermined criteria, documented by repeated photographs, and confirmed by an independent data review committee. Patients were randomized to receive either 400 mg of moxifloxacin iv once daily followed by 400 mg of moxifloxacin orally once daily or 4.0/0.5 g of TZP iv thrice daily followed by 875/125 mg of AMC orally twice daily for 7–21 days. The primary efficacy variable was clinical response at test of cure (TOC) for the per-protocol (PP) population. Clinical efficacy was assessed by the data review committee based on repeated photographs and case descriptions. Clinical trials registry number: NCT 00402727. Results A total of 813 patients were randomized. Clinical success rates at TOC were similar for moxifloxacin and TZP–AMC in the PP [320/361 (88.6%) versus 275/307 (89.6%), respectively; P = 0.758] and intent-to-treat (ITT) [350/426 (82.2%) versus 305/377 (80.9%), respectively; P = 0.632] populations. Thus, moxifloxacin was non-inferior to TZP–AMC. Bacteriological success rates were high in both treatment arms [moxifloxacin: 432/497 (86.9%) versus TZP–AMC: 370/429 (86.2%), microbiologically valid (MBV) population]. Moxifloxacin was non-inferior to TZP–AMC at TOC in both the MBV and the ITT populations. Both treatments were well tolerated. Conclusions Once-daily iv/oral moxifloxacin monotherapy was clinically and bacteriologically non-inferior to iv TZP thrice daily followed by oral AMC twice daily in patients with cSSSIs. PMID:21896561

Effect on Clinical Outcome and Growth Factor Synthesis With Adjunctive Use of Pulsed Electromagnetic Fields for Fifth Metatarsal Nonunion Fracture: A Double-Blind Randomized Study.

PubMed

Streit, Adam; Watson, B Collier; Granata, Jaymes D; Philbin, Terrence M; Lin, Hsuan-Ni; O'Connor, J Patrick; Lin, Sheldon

2016-09-01

Electromagnetic bone growth stimulators have been found to biologically enhance the bone healing environment, with upregulation of numerous growth factors. The purpose of the study was to quantify the effect, in vivo, of pulsed electromagnetic fields (PEMFs) on growth factor expression and healing time in fifth metatarsal nonunions. This was a prospective, randomized, double-blind trial of patients, cared for by 2 fellowship-trained orthopedic foot and ankle surgeons. Inclusion criteria consisted of patients between 18 and 75 years old who had been diagnosed with a fifth metatarsal delayed or nonunion, with no progressive signs of healing for a minimum of 3 months. Eight patients met inclusion criteria and were randomized to receive either an active stimulation or placebo PEMF device. Each patient then underwent an open biopsy of the fracture site and was fitted with the appropriate PEMF device. The biopsy was analyzed for messenger-ribonucleic acid (mRNA) levels using quantitative competitive reverse transcription polymerase chain reaction (QT-RT-PCR). Three weeks later, the patient underwent repeat biopsy and open reduction and internal fixation of the nonunion site. The patients were followed at 2- to 4-week intervals with serial radiographs and were graded by the number of cortices of healing. All fractures healed, with an average time to complete radiographic union of 14.7 weeks and 8.9 weeks for the inactive and active PEMF groups, respectively. A significant increase in placental growth factor (PIGF) level was found after active PEMF treatment (P = .043). Other factors trended higher following active PEMF including brain-derived neurotrophic factor (BDNF), bone morphogenetic protein (BMP) -7, and BMP-5. The adjunctive use of PEMF for fifth metatarsal fracture nonunions produced a significant increase in local placental growth factor. PEMF also produced trends toward higher levels of multiple other factors and faster average time to radiographic union compared to unstimulated controls. Level I, prospective randomized trial. © The Author(s) 2016.

Abelmoschus manihot - a traditional Chinese medicine versus losartan potassium for treating IgA nephropathy: study protocol for a randomized controlled trial.

PubMed

Li, Ping; Chen, Yi-Zhi; Lin, Hong-Li; Ni, Zhao-Hui; Zhan, Yong-Li; Wang, Rong; Yang, Hong-Tao; Fang, Jing-Ai; Wang, Nian-Song; Li, Wen-Ge; Sun, Xue-Feng; Chen, Xiang-Mei

2017-04-11

IgA nephropathy (IgAN) is one of the most common primary glomerular diseases worldwide, but effective therapy remains limited and many patients progress to end-stage renal disease (ESRD). Only angiotensin-converting enzyme inhibitors (ACE-I)/angiotensin-receptor blockers (ARB) show a high level of evidence (1B level) of being of value in the treatment for IgAN according to the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. However, traditional Chinese medicine has raised attention in kidney disease research. Abelmoschus manihot, a single medicament of traditional Chinese medicine has shown therapeutic effects in primary glomerular disease according to the randomized controlled clinical trial that we have completed. Here, we conduct a new study to assess the efficacy and safety of Abelmoschus manihot in IgAN. Also, this study is currently the largest double-blind, randomized controlled registered clinical research for the treatment of IgAN. We will conduct a multicenter, prospective, double-blind, double-dummy randomized controlled study. The study is designed as a noninferiority clinical trial. Approximately 1600 biopsy-proven IgAN patients will be enrolled at 100 centers in China and followed up for as long as 48 weeks. IgAN patients will be randomized assigned to the Abelmoschus manihot group (in the form of a huangkui capsule, 2.5 g, three times per day) and the losartan potassium group (losartan potassium, 100 mg/d). The primary outcome is the change in 24-h proteinuria from baseline after 48 weeks of treatment. Change in estimated glomerular filtration rate (eGFR) from baseline after 48 weeks of treatment, the incidence of endpoint events (proteinuria ≥3.5 g/24 h, the doubling of serum creatinine, or receiving blood purification treatment) are the secondary outcomes. Twenty-four-hour proteinuria and eGFR are measured at 0, 4, 12, 24, 36 and 48 weeks. This study will be of sufficient size and scope to evaluate the efficacy and safety of Abelmoschus manihot compared to losartan potassium in treating patients with IgAN. The results of this study may provide a new, effective and safe treatment strategy for IgAN. ClinicalTrials.gov, identifier: NCT02231125 . Registered on 30 August 2014.

Can we find the perfect oil to protect the perineum? A randomized-controlled double-blind trial.

PubMed

Harlev, Avi; Pariente, Gali; Kessous, Roy; Aricha-Tamir, Barak; Weintraub, Adi Y; Eshkoli, Tamar; Dukler, Doron; Ayun, Saviona Ben; Sheiner, Eyal

2013-09-01

To determine whether perineal massage during the second stage of labor using oil enriched with vitamins, increases the chances of delivering with an intact perineum as compared to perineal massage using pure liquid wax. A prospective, randomized, double-blind study was conducted. Women were assigned to liquid wax (jojoba oil) versus purified formula of almond and olive oil, enriched with vitamin B1, B2, B6, E and fatty acids. The caregivers used the oils during the second stage of labor. A total of 164 women undergoing vaginal delivery were recruited. No significant differences regarding perineal lacerations, number of sutures and length of suturing were noted between the two groups. Likewise, while analyzing separately nulliparous and multiparous women, no significant differences were noted. Controlling for birth weight >4000 g, using the Mantel-Haenszel technique, no association was noted between perineal lacerations and the type of oil used (weighted OR = 0.9, 95% CI 0.3-2.4; p = 0.818). The type of the oil used during the second stage of labor for prevention of perineal tears has no effect on the integrity of the perineum. Accordingly, it seems that there is no perfect oil.

Effect of prophylactic amoxicillin on endodontic flare-up in asymptomatic, necrotic teeth.

PubMed

Pickenpaugh, L; Reader, A; Beck, M; Meyers, W J; Peterson, L J

2001-01-01

The purpose of this prospective, randomized, double-blind, placebo-controlled study was to determine the effect of prophylactic amoxicillin on the occurrence of endodontic flare-up in asymptomatic, necrotic teeth. Seventy patients participated and had a clinical diagnosis of an asymptomatic, necrotic tooth with associated periapical radiolucency. One hour before endodontic treatment, patients randomly received either 3 g of amoxicillin or 3 g of a placebo control in a double-blind manner. After endodontic treatment, each patient received: ibuprofen; acetaminophen with codeine (30 mg); and a 5 1/2-day diary to record pain, swelling, percussion pain, and number and type of pain medication taken. The results demonstrated 10% of the 70 patients had a flare-up characterized by moderate-to-severe postoperative pain or swelling that began approximately 30 h after endodontic treatment and persisted for an average of 74 h. Of the seven patients who had flare-ups, 4 were in the amoxicillin group and 3 were not. Prophylactic amoxicillin did not significantly (p = 0.80) influence the endodontic flare-up. We concluded that a prophylactic dose of amoxicillin before endodontic treatment of asymptomatic, necrotic teeth had no effect on the endodontic flare-up.

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

PubMed

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

2017-01-01

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

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

PubMed Central

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

2017-01-01

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

Effect of an intraosseous injection of depo-medrol on pulpal concentrations of PGE2 and IL-8 in untreated irreversible pulpitis.

PubMed

Isett, James; Reader, Al; Gallatin, Eric; Beck, Mike; Padgett, David

2003-04-01

The purpose of this prospective, randomized, double-blind study was to evaluate the pulpal concentrations of prostaglandin E2 (PGE2) and interleukin-8 (IL-8) in untreated teeth with irreversible pulpitis after the administration of an intraosseous injection of Depo-Medrol. Forty emergency patients with a clinical diagnosis of irreversible pulpitis experiencing moderate to severe pain participated. After receiving local anesthesia, patients randomly received, in a double-blind manner, an intraosseous injection of either 1 ml of Depo-Medrol (40 mg) (20 patients) or 1 ml of sterile saline placebo (control) (20 patients). No endodontic treatment was initiated. At 1 or 3 days after the intraosseous injection, the teeth were extracted and the pulpal tissue harvested. Prostaglandin E2 and interleukin-8 concentrations were determined by enzyme immunoassay. Results demonstrated a significantly (p < 0.05) lower concentration of prostaglandin E2 compared to the saline group at day 1. There were no significant (p > 0.05) differences between the two groups at day 3. The pulpal concentrations of prostaglandin E2 were reduced at 1 day after the intraosseous injection of Depo-Medrol.

Adding Paracetamol to Ibuprofen for the Treatment of Patent Ductus Arteriosus in Preterm Infants: A Double-Blind, Randomized, Placebo-Controlled Pilot Study.

PubMed

Hochwald, Ori; Mainzer, Gur; Borenstein-Levin, Liron; Jubran, Huda; Dinur, Gil; Zucker, Meirav; Mor, Malka; Khoury, Asaad; Kugelman, Amir

2018-05-21

 The objective of this study was to compare the closure rate of hemodynamically significant patent ductus arteriosus (hsPDA) of intravenous ibuprofen + paracetamol (acetaminophen) versus ibuprofen + placebo, in preterm infants of 24 to 31 6/7 weeks postmenstrual age.  This is a single-center, double-blind, randomized controlled pilot study. Infants were assigned for treatment with either intravenous ibuprofen + paracetamol ( n  = 12) or ibuprofen + placebo ( n  = 12).  There was no statistical difference in baseline characteristics of the two groups. Echocardiography parameters were comparable before treatment in both groups. There was a trend toward higher hsPDA closure rate in the paracetamol group in comparison to the placebo group (83 vs. 42%, p  = 0.08). No adverse effects, clinical or laboratory, were associated with adding paracetamol.  Our pilot study was unable to detect a beneficial effect by adding intravenous paracetamol to ibuprofen for the treatment of hsPDA. Larger prospective studies are needed to explore the positive tendency suggested by our results and to assure safety. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Photobiomodulation with non-thermal lasers: Mechanisms of action and therapeutic uses in dermatology and aesthetic medicine.

PubMed

Nestor, Mark; Andriessen, Anneke; Berman, Brian; Katz, Bruce E; Gilbert, Dore; Goldberg, David J; Gold, Michael H; Kirsner, Robert S; Lorenc, Paul Z

2017-08-01

Non-thermal laser therapy in dermatology, is a growing field in medical technology by which therapeutic effects are achieved by exposing tissues to specific wavelengths of light. The purpose of this review was to gain a better understanding of the science behind non-thermal laser and the evidence supporting its use in dermatology. A group of dermatologists and surgeons recently convened to review the evidence supporting the use of non-thermal laser for body sculpting, improving the appearance of cellulite, and treating onychomycosis. The use of non-thermal laser for body sculpting is supported by three randomized, double-blind, sham-controlled studies (N = 161), one prospective open-label study (N = 54), and two retrospective studies (N = 775). Non-thermal laser application for improving the appearance of cellulite is supported by one randomized, double-blind, sham-controlled study (N = 38). The use of non-thermal laser for the treatment of onychomycosis is supported by an analysis of three non-randomized, open-label studies demonstrating clinical improvement of nails (N = 292). Non-thermal laser is steadily moving into mainstream medical practice, such as dermatology. Although present studies have demonstrated the safety and efficacy of non-thermal laser for body sculpting, cellulite reduction and onychomycosis treatment, studies demonstrating the efficacy of non-thermal laser as a stand-alone procedure are still inadequate.

A novel combination of the Arndt endobronchial blocker and the laryngeal mask airway ProSeal™ provides one-lung ventilation for thoracic surgery

PubMed Central

LI, QIONG; LI, PEIYING; XU, JIANGHUI; GU, HUAHUA; MA, QINYUN; PANG, LIEWEN; LIANG, WEIMIN

2014-01-01

In this study, the feasibility and performance of the combination of the Arndt endobronchial blocker and the laryngeal mask airway (LMA) ProSeal™ in airway establishment, ventilation, oxygenation and lung isolation was evaluated. Fifty-five patients undergoing general anesthesia for elective thoracic surgeries were randomly allocated to group Arndt (n=26) or group double-lumen tube (DLT; n=29). Data concerning post-operative airway morbidity, ease of insertion, hemodynamics, lung collapse, ventilators, oxygenation and ventilation were collected for analysis. Compared with group DLT, group Arndt showed a significantly attenuated hemodynamic response to intubation (blood pressure, 149±31 vs. 115±16 mmHg; heart rate, 86±15 vs. 68±15 bpm), less severe injuries to the bronchus (injury score, 1.4±0.2 vs. 0.4±0.1) and vocal cords (injury score, 1.3±0.2 vs. 0.6±0.1), and lower incidences of post-operative sore throat and hoarseness. Furthermore, the novel combination of the Arndt and the LMA ProSeal showed similar ease of airway establishment, comparable ventilation and oxygenation performance, and an analogous lung isolation effect to DLT. The novel combined use of the Arndt endobronchial blocker and the LMA ProSeal can serve as a promising alternative for thoracic procedures requiring one-lung ventilation. The less traumatic properties and equally ideal lung isolation are likely to promote its use in rapidly spreading minimally invasive thoracic surgeries. PMID:25289071

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

Ease of intubation: A randomized, double-blind study to compare two doses of rocuronium bromide for endotracheal intubation.

PubMed

Shukla, Aparna; Misra, Shilpi

2016-01-01

Clinical need for a nondepolarizing agent with a rapid onset time and a brief duration of action has led to the development of rocuronium bromide. The aim of this study was to evaluate optimal dose of rocuronium bromide for intubation and to compare the onset time, duration of action, intubating conditions, and hemodynamic effects of two doses of rocuronium bromide. A prospective, randomized, double-blind study. All the patients were divided in a randomized, double-blind fashion into two groups of twenty patients each. Group I patients received rocuronium bromide 0.6 mg/kg intravenously and intubated at 60 s, Group II patients received rocuronium bromide 0.9 mg/kg and intubated at 60 s. The neuromuscular block was assessed using single twitch stimulation of 0.1 Hz at adductor pollicis muscle of hand at every 10 s. The results were compiled and analyzed statistically using Chi-square test for qualitative data and Student's t -test for quantitative data. Time of onset was significantly shorter ( P < 0.01) and duration of action was prolonged ( P < 0.001) for Group II as compared to Group I. The intubating conditions were (excellent + good) in 100% patients of Group II and (excellent + good) in 80% of Group I. There was no significant change in pulse rate and mean arterial pressure from the baseline value after the administration of muscle relaxants in either of the two groups. Rocuronium bromide 0.9 mg/kg is a safer alternative to rocuronium bromide 0.6 mg/kg for endotracheal intubation with shorter time of onset and better intubating conditions.

Effect of local anesthetic dilution on the onset time and duration of double-injection sciatic nerve block: a prospective, randomized, blinded evaluation.

PubMed

Cappelleri, Gianluca; Ambrosoli, Andrea Luigi; Turconi, Stefania; Gemma, Marco; Ricci, Erika Basso; Cornaggia, Gabriele

2014-08-01

Among the various factors influencing the success rate, onset time, and duration of peripheral nerve blocks, the role of local anesthetics concentration remains uncertain. In this prospective, randomized, single-blinded study, we evaluated whether varying the dilution of a fixed dose of mepivacaine solution influenced onset time and duration of sciatic nerve block. Ninety ASA physical status I to II patients scheduled for foot surgery were randomly allocated to receive a double-injection Labat sciatic nerve block with 12 mL mepivacaine 2% (group concentration I = 45 patients) or 24 mL of mepivacaine 1% (group volume II = 45 patients). The nerve stimulator was initially set at 2 Hz, 0.1 millisecond, 1 mA. The total amount of local anesthetic (240 mg) was kept constant and equally divided between the peroneal and tibial nerves. All patients also received an ultrasound-guided popliteal sciatic nerve catheter for postoperative analgesia. Times to readiness for surgery, performance, and offset of local anesthetic were recorded. Our primary end point was to determine a possible difference in offset time between groups. Continuous variables were expressed as median (IQR) and compared with the Wilcoxon-Mann-Whitney U test; WMWodds are reported together with their 95% confidence interval. The overall success rate of sciatic nerve block was 99%. Time of performance was shorter in group I, 120 seconds (90-150 seconds), than that in group II, 150 seconds (120-180 seconds) (P = 0.0048; WMWodds 2.26 [1.35-4.34]). The onset time of sensory and motor sciatic nerve block was 4 minutes (2-9 minutes) in group I and 6 minutes (4-10 minutes) in group II (P = 0.41; WMWodds 1.21 [0.77-1.95]), while the duration of sensory block was 235 minutes (203-250 minutes) in group I, and 240 minutes (218-247 minutes) in group II respectively (P = 0.51; WMWodds 1.20 [0.69-2.16]). We found no evidence that varying volume and concentration while maintaining a fixed total dose of mepivacaine alters the onset time and duration of double-injection sciatic nerve block. Considering our WMWodds results, possible differences in onset time and duration comparable to differences in the performance time between groups cannot be excluded.

Specialization of the auditory processing in harbor porpoise, characterized by brain-stem potentials

NASA Astrophysics Data System (ADS)

Bibikov, Nikolay G.

2002-05-01

Brain-stem auditory evoked potentials (BAEPs) were recorded from the head surface of the three awaked harbor porpoises (Phocoena phocoena). Silver disk placed on the skin surface above the vertex bone was used as an active electrode. The experiments were performed at the Karadag biological station (the Crimea peninsula). Clicks and tone bursts were used as stimuli. The temporal and frequency selectivity of the auditory system was estimated using the methods of simultaneous and forward masking. An evident minimum of the BAEPs thresholds was observed in the range of 125-135 kHz, where the main spectral component of species-specific echolocation signal is located. In this frequency range the tonal forward masking demonstrated a strong frequency selectivity. Off-response to such tone bursts was a typical observation. An evident BAEP could be recorded up to the frequencies 190-200 kHz, however, outside the acoustical fovea the frequency selectivity was rather poor. Temporal resolution was estimated by measuring BAER recovery functions for double clicks, double tone bursts, and double noise bursts. The half-time of BAERs recovery was in the range of 0.1-0.2 ms. The data indicate that the porpoise auditory system is strongly adapted to detect ultrasonic closely spaced sounds like species-specific locating signals and echoes.

Social learning spreads knowledge about dangerous humans among American crows

PubMed Central

Cornell, Heather N.; Marzluff, John M.; Pecoraro, Shannon

2012-01-01

Individuals face evolutionary trade-offs between the acquisition of costly but accurate information gained firsthand and the use of inexpensive but possibly less reliable social information. American crows (Corvus brachyrhynchos) use both sources of information to learn the facial features of a dangerous person. We exposed wild crows to a novel ‘dangerous face’ by wearing a unique mask as we trapped, banded and released 7–15 birds at five study sites near Seattle, WA, USA. An immediate scolding response to the dangerous mask after trapping by previously captured crows demonstrates individual learning, while an immediate response by crows that were not captured probably represents conditioning to the trapping scene by the mob of birds that assembled during the capture. Later recognition of dangerous masks by lone crows that were never captured is consistent with horizontal social learning. Independent scolding by young crows, whose parents had conditioned them to scold the dangerous mask, demonstrates vertical social learning. Crows that directly experienced trapping later discriminated among dangerous and neutral masks more precisely than did crows that learned through social means. Learning enabled scolding to double in frequency and spread at least 1.2 km from the place of origin over a 5 year period at one site. PMID:21715408

Concomitant or sequential administration of live attenuated japanese encephalitis chimeric virus vaccine and yellow fever 17D vaccine

PubMed Central

Nasveld, Peter E; Marjason, Joanne; Bennett, Sonya; Aaskov, John; Elliott, Suzanne; McCarthy, Karen; Kanesa-thasan, Niranjan; Feroldi, Emmanuel

2010-01-01

A randomized, double-blind, study was conducted to evaluate the safety, tolerability and immunogenicity of a live attenuated Japanese encephalitis chimeric virus vaccine (JE-CV) co-administered with live attenuated yellow fever (YF) vaccine (YF-17D strain; Stamaril®, Sanofi Pasteur) or administered sequentially. Participants (n = 108) were randomized to receive: YF followed by JE-CV 30 days later, JE followed by YF 30 days later, or the co-administration of JE and YF followed or preceded by placebo 30 days later or earlier. Placebo was used in a double-dummy fashion to ensure masking. Neutralizing antibody titers against JE-CV, YF-17D and selected wild-type JE virus strains was determined using a 50% serum-dilution plaque reduction neutralization test (PRNT50). Seroconversion was defined as the appearance of a neutralizing antibody titer above the assay cut-off post-immunization when not present pre-injection at day 0, or a least a four-fold rise in neutralizing antibody titer measured before the pre-injection day 0 and later post vaccination samples. There were no serious adverse events. Most adverse events (AEs) after JE vaccination were mild to moderate in intensity, and similar to those reported following YF vaccination. Seroconversion to JE-CV was 100% and 91% in the JE/YF and YF/JE sequential vaccination groups, respectively, compared with 96% in the co-administration group. All participants seroconverted to YF vaccine and retained neutralizing titers above the assay cut-off at month six. Neutralizing antibodies against JE vaccine were detected in 82–100% of participants at month six. These results suggest that both vaccines may be successfully co-administered simultaneously or 30 days apart. PMID:20864814

Look before you leap: sensory memory improves decision making.

PubMed

Vlassova, Alexandra; Pearson, Joel

2013-09-01

Simple decisions require the processing and evaluation of perceptual and cognitive information, the formation of a decision, and often the execution of a motor response. This process involves the accumulation of evidence over time until a particular choice reaches a decision threshold. Using a random-dot-motion stimulus, we showed that simply delaying responses after the stimulus offset can almost double accuracy, even in the absence of new incoming visual information. However, under conditions in which the otherwise blank interval was filled with a sensory mask or concurrent working memory load was high, performance gains were lost. Further, memory and perception showed equivalent rates of evidence accumulation, suggesting a high-capacity memory store. We propose an account of continued evidence accumulation by sequential sampling from a simultaneously decaying memory trace. Memories typically decay with time, hence immediate inquiry trumps later recall from memory. However, the results we report here show the inverse: Inspecting a memory trumps viewing the actual object.

Clobetasol propionate shampoo 0.05%: a new option to treat patients with moderate to severe scalp psoriasis.

PubMed

Jarratt, Michael; Breneman, Debra; Gottlieb, Alice B; Poulin, Yves; Liu, Yin; Foley, Valerie

2004-01-01

Psoriasis is a chronic, papulosquamous condition that affects up to 2% of the U.S. population. Approximately 50% of patients with psoriasis have involvement of the scalp. This was a multicentre, randomized, vehicle-controlled, double-masked and parallel-group study. The aim was to evaluate the efficacy and safety of clobetasol propionate shampoo, 0.05% versus its corresponding vehicle in subjects aged 12 years and older with moderate to severe scalp psoriasis over a treatment period of 4 weeks. Recurrence of scalp psoriasis was assessed during a two week follow-up period. A total of 142 subjects were treated. Results after 4 weeks demonstrated that clobetasol propionate shampoo, 0.05% was with a similar safety profile significantly more effective than its vehicle. The novel short contact shampoo formulation of clobetasol propionate is convenient and efficacious and minimizes systemic exposure while being efficient, safe and well-tolerated in the treatment of moderate to severe scalp psoriasis.

Effect of trimetazidine on recurrent angina pectoris and left ventricular structure in elderly multivessel coronary heart disease patients with diabetes mellitus after drug-eluting stent implantation: a single-centre, prospective, randomized, double-blind study at 2-year follow-up.

PubMed

Xu, Xiaohan; Zhang, Weijun; Zhou, Yujie; Zhao, Yingxin; Liu, Yuyang; Shi, Dongmei; Zhou, Zhiming; Ma, Hanying; Wang, Zhijian; Yu, Miao; Ma, Qian; Gao, Fei; Shen, Hua; Zhang, Jianwei

2014-04-01

Trimetazidine has been shown to improve angina pectoris and left ventricular (LV) function in diabetic patients with ischaemic cardiomyopathy. The objective of this study was to evaluate the effects of trimetazidine on recurrent angina pectoris and LV structure after drug-eluting stent (DES) implantation in elderly multivessel coronary heart disease (CHD) patients with diabetes mellitus (DM) and a left ventricular ejection fraction (LVEF) of ≥ 50 %. This was a single-centre, prospective, randomized, double-blind evaluation study. Between January 2010 and September 2010, 700 CHD patients with DM who were aged ≥ 65 years and undergoing coronary angiography at An Zhen Hospital (Beijing, China) were recruited and prospectively randomized to receive trimetazidine (20 mg three times daily) or placebo after DES implantation as an addition to conventional CHD treatment. The primary end points were the incidence of recurrent angina pectoris and measures of various echocardiographic parameters, which included LVEF. At 2-year follow-up, patients in the trimetazidine group (n = 255) showed significant improvements in the incidence (P = 0.024) and severity of angina pectoris, compared with the control group, as well as silent myocardial ischaemia (P = 0.009) and angina pectoris-free survival (P = 0.011). LV function and structure in trimetazidine-treated patients were relatively stable at 2-year follow-up, while they deteriorated in the control group (n = 255) with a significant difference between groups (all P < 0.01). The E peak to A peak (E/A) ratio in trimetazidine-treated patients and in the control group decreased after 2 years; the E/A ratio in trimetazidine-treated patients was slightly better than that in the control group, without a significant difference (P = 0.170). There was no significant difference in event-free survival for the composite end point including death, myocardial infarction, cerebrovascular accident (P = 0.422) and subsequent revascularization (P = 0.073). Adjunctive therapy with trimetazidine after DES implantation can have a beneficial effect on recurrent angina pectoris as well as LV function and structure in elderly multivessel CHD patients with DM.

Comparison of preservative-free latanoprost and preservative-free bimatoprost in a multicenter, randomized, investigator-masked cross-over clinical trial, the SPORT trial.

PubMed

Stalmans, Ingeborg; Oddone, Francesco; Cordeiro, Maria Francesca; Hommer, Anton; Montesano, Giovanni; Ribeiro, Luisa; Sunaric-Mégevand, Gordana; Rossetti, Luca

2016-06-01

The aim of this study was to investigate the efficacy and safety of Bimatoprost Unit Dose Preservative Free (BUDPF) and Latanoprost Unit Dose Preservative Free (LUDPF). A prospective, randomized, investigator-masked, cross-over comparison was used. Inclusion criteria were ocular hypertension (OHT) or open-angle glaucoma (OAG) with a maximum intraocular pressure (IOP) of 21 mmHg on a preserved prostaglandin monotherapy. After 6 weeks washout, patients were randomized to BUDPF or LUDPF for 3 months and then switched to the other treatment for 3 months. IOP curves were performed at baseline and after each treatment period. Statistical analysis was performed in a R programming environment. Linear mixed modeling was used to account for repeated measures on the same subject and clustering of observations from the same center. Safety outcomes included visual acuity, adverse events, slit-lamp biomicroscopy, ocular tolerability, and optic nerve assessment. Analysis at 6 months (primary outcome) showed a 1.6 ± 0.5-mmHg difference in IOP values between LUDPF and BUDPF (p < 0.01). A mean intra-subject IOP difference of 0.9 ± 0.2 mmHg (LUDPF - BUDPF) was observed (p < 0.01).. Significant differences in IOP were observed for both drugs at 3 and at 6 months compared to baseline: -4,0 ± 0.5 mmHg for both BUDPF and LUDPF at 3 months (p < 0.01 for both drugs; p = 0.32 between the two drugs); -5.2 ± 0.5 and -3.4 ± 0.5 mmHg for BUDPF and LUDPF, respectively (both p < 0.01), at 6 months. Both drugs were tolerated well, the only statistically significant difference being lower hyperemia scores for LUDPF (albeit low for both drugs). This study demonstrates a superior efficacy of BUDPF over LUDPF in lowering IOP. The results are consistent both in the parallel comparison between the two treatment groups at 6 months as well as in the intra-subject pressure comparison.

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.

Update on the Methodological Quality of Research Published in The American Journal of Sports Medicine: Comparing 2011-2013 to 10 and 20 Years Prior.

PubMed

Brophy, Robert H; Kluck, Dylan; Marx, Robert G

2016-05-01

In recent years, the number of articles in The American Journal of Sports Medicine (AJSM) has risen dramatically, with an increasing emphasis on evidence-based medicine in orthopaedics and sports medicine. Despite the increase in the number of articles published in AJSM over the past decade, the methodological quality of articles in 2011-2013 has improved relative to those in 2001-2003 and 1991-1993. Meta-analysis. All articles published in AJSM during 2011-2013 were reviewed and classified by study design. For each article, the use of pertinent methodologies, such as prospective data collection, randomization, control groups, and blinding, was recorded. The frequency of each article type and the use of evidence-based techniques were compared relative to 1991-1993 and 2001-2003 by use of Pearson χ(2) testing. The number of research articles published in AJSM more than doubled from 402 in 1991-1993 and 423 in 2001-2003 to 953 in 2011-2013. Case reports decreased from 15.2% to 10.6% to 2.1% of articles published over the study period (P < .001). Cadaveric/human studies and meta-analysis/literature review studies increased from 5.7% to 7.1% to 12.4% (P < .001) and from 0.2% to 0.9% to 2.3% (P = .01), respectively. Randomized, prospective clinical trials increased from 2.7% to 5.9% to 7.4% (P = .007). Fewer studies used retrospective compared with prospective data collection (P < .001). More studies tested an explicit hypothesis (P < .001) and used controls (P < .001), randomization (P < .001), and blinding of those assessing outcomes (P < .001). Multi-investigator trials increased (P < .001), as did the proportion of articles citing a funding source (P < .001). Despite a dramatic increase in the number of published articles, the research published in AJSM shifted toward more prospective, randomized, controlled, and blinded designs during 2011-2013 compared with 2001-2003 and 1991-1993, demonstrating a continued improvement in methodological quality. © 2015 The Author(s).

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

Effects of fentanyl administration before induction of anesthesia and placement of the Laryngeal Mask Airway: a randomized, placebo-controlled trial.

PubMed

Joshi, Girish P; Kamali, Amin; Meng, Jin; Rosero, Eric; Gasanova, Irina

2014-03-01

To assess the effects of fentanyl administered before induction of anesthesia on movement and airway responses during desflurane anesthesia via the Laryngeal Mask Airway (LMA). Randomized, double-blinded, controlled trial. Tertiary-care academic center. 100 adult, ASA physical status 1, 2, and 3 patients undergoing ambulatory surgery. Patients were administered fentanyl 1 μg/kg (n=51) or saline (n=49) 3 to 5 minutes before induction with propofol 2-2.5 mg/kg intravenously (IV), followed by LMA placement. Anesthesia was maintained with desflurane titrated to a bispectral index (BIS) of 50-60 and 50% nitrous oxide in oxygen, and fentanyl 25 μg boluses were titrated to respiratory rate. Apnea occurrence and duration of manual ventilation, as well as frequency and severity of movement, coughing, breath holding, and laryngospasm were recorded. Two patients in each group were excluded from analysis. The fentanyl pretreatment group had a higher frequency of apnea (94% vs 64%; P=0.0003) and longer duration of manual ventilation (3 [interquartile range (IQR), 1.5-5] min vs 1 [0-1.5] min; P<0.0001) at induction. In contrast, the fentanyl pretreatment group had a lower frequency of movements (16% vs 51%;P=0.0001). The rates of intraoperative breath holding (6.1% vs 8.5%) and laryngospasm (2% vs 4.3%) in the two groups were similar. All subjects experiencing laryngospasm were smokers. Adjusting for smoking status did not affect the differences noted in apnea, duration of manual ventilation, or movement between groups; however, coughing occurrence was statistically higher in the placebo group (P=0.043). Preinduction fentanyl increased the frequency of apnea at induction and duration of manual ventilation, but reduced the frequency of movements. In addition, it reduced intraoperative coughing in smokers. Copyright © 2014 Elsevier Inc. All rights reserved.

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

Rescue therapy by switching to total face mask after failure of face mask-delivered noninvasive ventilation in do-not-intubate patients in acute respiratory failure.

PubMed

Lemyze, Malcolm; Mallat, Jihad; Nigeon, Olivier; Barrailler, Stéphanie; Pepy, Florent; Gasan, Gaëlle; Vangrunderbeeck, Nicolas; Grosset, Philippe; Tronchon, Laurent; Thevenin, Didier

2013-02-01

To evaluate the impact of switching to total face mask in cases where face mask-delivered noninvasive mechanical ventilation has already failed in do-not-intubate patients in acute respiratory failure. Prospective observational study in an ICU and a respiratory stepdown unit over a 12-month study period. Switching to total face mask, which covers the entire face, when noninvasive mechanical ventilation using facial mask (oronasal mask) failed to reverse acute respiratory failure. Seventy-four patients with a do-not-intubate order and treated by noninvasive mechanical ventilation for acute respiratory failure. Failure of face mask-delivered noninvasive mechanical ventilation was associated with a three-fold increase in in-hospital mortality (36% vs. 10.5%; p = 0.009). Nevertheless, 23 out of 36 patients (64%) in whom face mask-delivered noninvasive mechanical ventilation failed to reverse acute respiratory failure and, therefore, switched to total face mask survived hospital discharge. Reasons for switching from facial mask to total face mask included refractory hypercapnic acute respiratory failure (n = 24, 66.7%), painful skin breakdown or facial mask intolerance (n = 11, 30%), and refractory hypoxemia (n = 1, 2.7%). In the 24 patients switched from facial mask to total face mask because of refractory hypercapnia, encephalopathy score (3 [3-4] vs. 2 [2-3]; p < 0.0001), PaCO2 (87 ± 25 mm Hg vs. 70 ± 17 mm Hg; p < 0.0001), and pH (7.24 ± 0.1 vs. 7.32 ± 0.09; p < 0.0001) significantly improved after 2 hrs of total face mask-delivered noninvasive ventilation. Patients switched early to total face mask (in the first 12 hrs) developed less pressure sores (n = 5, 24% vs. n = 13, 87%; p = 0.0002), despite greater length of noninvasive mechanical ventilation within the first 48 hrs (44 hrs vs. 34 hrs; p = 0.05) and less protective dressings (n = 2, 9.5% vs. n = 8, 53.3%; p = 0.007). The optimal cutoff value for face mask-delivered noninvasive mechanical ventilation duration in predicting facial pressure sores was 11 hrs (area under the receiver operating characteristic curve, 0.86 ± 0.04; 95% confidence interval 0.76-0.93; p < 0.0001; sensitivity, 84%; specificity, 71%). In patients in hypercapnic acute respiratory failure, for whom escalation to intubation is deemed inappropriate, switching to total face mask can be proposed as a last resort therapy when face mask-delivered noninvasive mechanical ventilation has already failed to reverse acute respiratory failure. This strategy is particularly adapted to provide prolonged periods of continuous noninvasive mechanical ventilation while preventing facial pressure sores.

Parecoxib sodium pretreatment reduces myoclonus after etomidate: A prospective, double-blind, randomized clinical trial
.

PubMed

Li, Xiuze; Liu, Jun; Zhou, Mengjun; Zhou, Chaojing

2017-07-01

Myoclonus induced by etomidate during induction of general anesthesia is a common phenomenon. This prospective, randomized, saline-controlled clinical study was performed to evaluate the effect of parecoxib sodium pretreatment on the incidence and severity of etomidate-induced myoclonus. 60 patients, American Society of Anesthesiologists (ASA) physical status I or II, aged 20 to 60 years, who were scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia, were allocated randomly into one of two groups to receive parecoxib sodium 40 mg intravenous (group P, n = 30) or the same volume of saline (group S, n = 30) 30 minutes before administration of etomidate (0.3 mg/kg). Myoclonus was assessed on a scale of 0 - 3. Postoperative side effects were recorded. The two groups were comparable with regard to baseline characteristics. The incidence of myoclonus was significantly lower in the parecoxib sodium group (11/30; 37%) than in the saline group (21/30; 70%) (p < 0.05). The severity of myoclonic movements was also significantly reduced by parecoxib sodium (p < 0.05). There were no significant differences between the two groups with respect to postoperative side effects. Pretreatment with intravenous injection of parecoxib sodium 40 mg significantly reduced the incidence and severity of etomidate-induced myoclonus without significant side effects.
.

Efficacy of perioperative parecoxib injection on postoperative pain relief after laparoscopic cholecystectomy: A prospective, randomized study

PubMed Central

Akaraviputh, Thawatchai; Leelouhapong, Charay; Lohsiriwat, Varut; Aroonpruksakul, Somkiat

2009-01-01

AIM: To determine the efficacy of perioperative parecoxib injection on postoperative pain relief after laparoscopic cholecystectomy. METHODS: A prospective, double-blind, randomized, placebo-controlled study was conducted on 70 patients who underwent elective laparoscopic cholecystectomy under general anesthesia at Siriraj Hospital, Bangkok, from January 2006 to December 2007. Patients were randomized to receive either 20 mg parecoxib infusion 30 min before induction of anesthesia and at 12 h after the first dose (treatment group), or normal saline infusion, in the same schedule, as a placebo (control group). The degree of the postoperative pain was assessed every 3 h in the first 24 h after surgery, and then every 12 h the following day, using a visual analog scale. The consumption of analgesics was also recorded. RESULTS: There were 40 patients in the treatment group, and 30 patients in the control group. The pain scores at each time point, and analgesic consumption did not differ between the two groups. However, there were fewer patients in the treatment group than placebo group who required opioid infusion within the first 24 h (60% vs 37%, P = 0.053). CONCLUSION: Perioperative administration of parecoxib provided no significant effect on postoperative pain relief after laparoscopic cholecystectomy. However, preoperative infusion 20 mg parecoxib could significantly reduce the postoperative opioid consumption. PMID:19399934

Effects of moderate red wine consumption on liver fat and blood lipids: a prospective randomized study.

PubMed

Kechagias, Stergios; Zanjani, Sepehr; Gjellan, Solveig; Leinhard, Olof Dahlqvist; Kihlberg, Johan; Smedby, Orjan; Johansson, Lars; Kullberg, Joel; Ahlström, Håkan; Lindström, Torbjörn; Nystrom, Fredrik H

2011-11-01

There have been no human prospective randomized studies of the amount of alcohol that can induce hepatic steatosis. Thirty-two healthy women and twelve healthy men (34 ± 9 years of age) were randomized to consume 150 ml of red wine/day for women (16 g ethanol/day) or double that amount for men (33 g ethanol/day), or to alcohol abstention for 90 days. Participants underwent proton-nuclear magnetic-resonance spectroscopy for measurement of hepatic triglyceride content (HTGC). Blood samples for assessment of cardiovascular risk were drawn before and after the intervention. After exclusion of three subjects with steatosis at baseline a trend towards increased HTGC was apparent for red wine (before median: 1.1%, range 0.2-3.9%, after median: 1.1%, range 0.5-5.2 %, P = 0.059) a difference that was statistically significant compared with abstainers (p = 0.02). However, no subject developed hepatic steatosis. Low-density lipoprotein (LDL)-cholesterol was lowered by red wine (-0.3 mmol/l, SE -0.1, 95% CI -0.6 to -0.04). Moderate consumption of red wine during three months increased HTGC in subjects without steatosis at baseline. However, since not a single participant developed steatosis we suggest that the threshold of alcohol consumption to define nonalcoholic fatty liver disease should not be lower than the amount in our study.

Face Masks for Noninvasive Ventilation: Fit, Excess Skin Hydration, and Pressure Ulcers.

PubMed

Visscher, Marty O; White, Cynthia C; Jones, Jennifer M; Cahill, Thomas; Jones, Donna C; Pan, Brian S

2015-11-01

Pressure ulcers (stages III and IV) are serious safety events (ie, never events). Healthcare institutions are no longer reimbursed for costs to care for affected patients. Medical devices are the leading cause of pediatric pressure ulcers. Face masks for noninvasive ventilation were associated with a high percentage of pressure ulcers at our institution. A prospective cohort study investigated factors contributing to pressure ulcer development in 50 subjects using face masks for noninvasive ventilation. Color imaging, 3-dimensional surface imaging, and skin hydration measurements were used to identify early skin compromise and evaluate 3 interventions to reduce trauma: (1) a silicone foam dressing, (2) a water/polyethylene oxide hydrogel dressing, and (3) a flexible cloth mask. A novel mask fit technique was used to examine the impact of fit on the potential for skin compromise. Fifty subjects age 10.4 ± 9.1 y participated with color images for 22, hydration for 34, and mask fit analysis for 16. Of these, 69% had diagnoses associated with craniofacial anomalies. Stage I pressure ulcers were the most common injury. Skin hydration difference was 317 ± 29 for sites with erythema versus 75 ± 28 for sites without erythema (P < .05) and smallest for the cloth mask (P < .05). Fit distance metrics differed for the nasal, oronasal, and face shield interfaces, with threshold distances being higher for the oronasal mask than the others (P < .05). Areas of high contact were associated with skin erythema and pressure ulcers. This fit method is currently being utilized to select best-fit masks from available options, to identify the potential areas of increased tissue pressure, and to prevent skin injuries and their complications. Improvement of mask fit is an important priority for improving respiratory outcomes. Strategies to maintain normal skin hydration are important for protecting tissue integrity. Copyright © 2015 by Daedalus Enterprises.

Randomized controlled trial of benzocaine versus placebo spray for pain relief at hysterosalpingogram.

PubMed

Bachman, E A; Senapati, S; Sammel, M D; Kalra, S K

2014-06-01

Many women experience pain during hysterosalpingogram (HSG). This prospective, randomized, double-blinded, placebo-controlled study assessed whether the use of benzocaine spray during HSG is associated with reduced pain as compared with placebo. Thirty women presenting for HSG were enrolled and randomized to either benzocaine or saline spray. Treatment groups were similar in age, race, parity, pre-procedure oral analgesic use and history of dysmenorrhoea and/or chronic pelvic pain. Median change in pain score from baseline to procedure was 50.6mm (-7.4 to 98.8mm) in the benzocaine group and 70.4mm (19.8 to 100mm) in the placebo group. There was no difference between groups after adjusting for history of dysmenorrhoea. There was no difference in resolution of pain in benzocaine versus placebo groups at 5 min post procedure--median pain score difference -11.1 (-90.1 to 18.5) versus -37.0 (-100 to 1.2)--or at 30 min post procedure. Satisfaction scores did not differ by treatment and did not correlate with pain score during the procedure (rho=0.005). The use of benzocaine spray does not significantly improve pain relief during HSG nor does it hasten resolution of pain post HSG. Of interest, patient satisfaction was not correlated with pain. Many women experience pain during hysterosalpingogram (HSG), which is a test used to evaluate the uterine cavity and fallopian tube. We conducted a prospective, randomized, double-blinded, placebo-controlled study to assess whether the use of benzocaine spray during HSG is associated with reduced pain as compared with placebo. Thirty women presenting for HSG were enrolled and randomized to either benzocaine or saline spray. Treatment groups were similar in age, race, previous pregnancies, pre-procedure oral analgesic use and history of dysmenorrhoea (painful periods) and/or chronic pelvic pain. There was no difference in pain scores or resolution of pain between the two groups. Satisfaction scores did not differ by treatment group and did not correlate with the pain score during the procedure. We conclude that the use of benzocaine spray does not significantly improve pain relief during HSG nor does it hasten resolution of pain post HSG. Of interest, patient satisfaction was not correlated with pain. Copyright © 2014 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

The NuSTAR Mission: Implementation and Science Prospects

NASA Technical Reports Server (NTRS)

Zhang, William W.

2009-01-01

NuSTAR is NASA's next X-ray observatory scheduled to be launched in 2011. It will have two multi-layered X-ray mirror assemblies capable of focusing X-rays in the band of 5 to 80 keV, providing unprecedented detection and imaging sensitivity in a band that only coded-mask or collimated detection has been possible. In this talk I will describe the instrumentation and the prospects of using it to perform various kinds of astronomical studies.

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

PubMed

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

2012-10-01

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

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.

Line-frequency doubling of directed self-assembly patterns for single-digit bit pattern media lithography

NASA Astrophysics Data System (ADS)

Patel, K. C.; Ruiz, R.; Lille, J.; Wan, L.; Dobiz, E.; Gao, H.; Robertson, N.; Albrecht, T. R.

2012-03-01

Directed self-assembly is emerging as a promising technology to define sub-20nm features. However, a straightforward path to scale block copolymer lithography to single-digit fabrication remains challenging given the diverse material properties found in the wide spectrum of self-assembling materials. A vast amount of block copolymer research for industrial applications has been dedicated to polystyrene-b-methyl methacrylate (PS-b-PMMA), a model system that displays multiple properties making it ideal for lithography, but that is limited by a weak interaction parameter that prevents it from scaling to single-digit lithography. Other block copolymer materials have shown scalability to much smaller dimensions, but at the expense of other material properties that could delay their insertion into industrial lithographic processes. We report on a line doubling process applied to block copolymer patterns to double the frequency of PS-b-PMMA line/space features, demonstrating the potential of this technique to reach single-digit lithography. We demonstrate a line-doubling process that starts with directed self-assembly of PS-b-PMMA to define line/space features. This pattern is transferred into an underlying sacrificial hard-mask layer followed by a growth of self-aligned spacers which subsequently serve as hard-masks for transferring the 2x frequency doubled pattern to the underlying substrate. We applied this process to two different block copolymer materials to demonstrate line-space patterns with a half pitch of 11nm and 7nm underscoring the potential to reach single-digit critical dimensions. A subsequent patterning step with perpendicular lines can be used to cut the fine line patterns into a 2-D array of islands suitable for bit patterned media. Several integration challenges such as line width control and line roughness are addressed.

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

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.

Repeated tender point injections of granisetron alleviate chronic myofascial pain--a randomized, controlled, double-blinded trial.

PubMed

Christidis, Nikolaos; Omrani, Shahin; Fredriksson, Lars; Gjelset, Mattias; Louca, Sofia; Hedenberg-Magnusson, Britt; Ernberg, Malin

2015-01-01

Serotonin (5-HT) mediates pain by peripheral 5-HT3-receptors. Results from a few studies indicate that intramuscular injections of 5-HT3-antagonists may reduce musculoskeletal pain. The aim of this study was to investigate if repeated intramuscular tender-point injections of the 5-HT3-antagonist granisetron alleviate pain in patients with myofascial temporomandibular disorders (M-TMD). This prospective, randomized, controlled, double blind, parallel-arm trial (RCT) was carried out during at two centers in Stockholm, Sweden. The randomization was performed by a researcher who did not participate in data collection with an internet-based application ( www.randomization.com ). 40 patients with a diagnose of M-TMD according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) were randomized to receive repeated injections, one week apart, with either granisetron (GRA; 3 mg) or isotonic saline as control (CTR). The median weekly pain intensities decreased significantly at all follow-ups (1-, 2-, 6-months) in the GRA-group (Friedman test; P < 0.05), but not in the CTR-group (Friedman-test; P > 0.075). The numbers needed to treat (NNT) were 4 at the 1- and 6-month follow-ups, and 3.3 at the 2-month follow-up in favor of granisetron. Repeated intramuscular tender-point injections with granisetron provide a new pharmacological treatment possibility for myofascial pain patients with repeated intramuscular tender-point injections with the serotonin type 3 antagonist granisetron. It showed a clinically relevant pain reducing effect in the temporomandibular region, both in a short- and long-term aspect. European Clinical Trials Database 2005-006042-41 as well as at Clinical Trials NCT02230371 .

Comparative Efficacy and Durability of Continuation Phase Cognitive Therapy for Preventing Recurrent Depression: Design of a Double-Blinded, Fluoxetine- and Pill-Placebo–Controlled, Randomized Trial with 2-Year Follow-up

PubMed Central

Thase, Michael E.

2010-01-01

Background Major depressive disorder (MDD) is highly prevalent and associated with disability and chronicity. Although cognitive therapy (CT) is an effective short-term treatment for MDD, a significant proportion of responders subsequently suffer relapses or recurrences. Purpose This design prospectively evaluates: 1) a method to discriminate CT-treated responders at lower versus higher risk for relapse; and 2) the subsequent durability of 8-month continuation phase therapies in randomized higher risk responders followed for an additional 24-months. The primary prediction is: after protocol treatments are stopped, higher risk patients randomly assigned to continuation phase CT (C-CT) will have a lower risk of relapse/recurrence than those randomized to fluoxetine (FLX). Methods Outpatients, aged 18 to 70 years, with recurrent MDD received 12–14 weeks of CT provided by 15 experienced therapists from two sites. Responders (i.e., no MDD and 17-item Hamilton Rating Scale for Depression ≤ 12) were stratified into higher and lower risk groups based on stability of remission during the last 6 weeks of CT. The lower risk group entered follow-up for 32 months; the higher risk group was randomized to 8 months of continuation phase therapy with either C-CT or clinical management plus either double-blinded FLX or pill placebo. Following the continuation phase, higher risk patients were followed by blinded evaluators for 24 months. Results The trial began in 2000. Enrollment is complete (N=523). The follow-up continues. Conclusions The trial evaluates the preventive effects and durability of acute and continuation phase treatments in the largest known sample of CT responders collected worldwide. PMID:20451668

Prospective double-blind clinical trial evaluating the effectiveness of Bromelain in the third molar extraction postoperative period

PubMed Central

de la Barrera-Núñez, María C.; Yáñez-Vico, Rosa M.; Batista-Cruzado, Antonio; Heurtebise-Saavedra, Jean M.; Castillo-de Oyagüe, Raquel

2014-01-01

Objectives: To evaluate the anti-inflammatory and analgesic effect of Bromelain (pineapple extract) administered orally in the postoperative after extraction of impacted lower molars. Study Design: This is a prospective, placebo-controlled, unicentric, double-blind study; the sample size was 34 patients. The pre and postoperative outcomes, evaluated on the third (D3) and eighth day (D8), included inflamtion, pain and oral aperture, as well as the need for analgesics. One group received bromelain 150mg per day for three days and 100mg on days 4 to 7. The other group received placebo in the same dosage. All outcomes werrecorded quantitatively and analyzed with the Mann-Whitney U test for independent samples. Results: Although there were no statistically significant differences between the treatment groups, a trend towards less inflammation and improved oral aperture was observed in the group that received bromelain, compared to the group that received placebo. This trend can be attributed completely to random reasons, since there is no statistical difference in the results. Conclusions: Further studies are necessary to analyze different administration patterns and doses of bromelain for the use in the postoperative of impacted third molars. Key words:Tooth extraction, third molar, postoperative period, bromeline, clinical study. PMID:24316697

Multi-modal intervention to reduce cardiovascular risk among hypertensive older adults: Design of a randomized clinical trial

PubMed Central

Buford, Thomas W.; Anton, Stephen D.; Bavry, Anthony; Carter, Christy S.; Daniels, Michael J.; Pahor, Marco

2015-01-01

Persons aged over 65 years account for over 75% of healthcare expenditures and deaths attributable to cardiovascular disease (CVD). Accordingly, reducing CVD risk among older adults is an important public health priority. Functional status, determined by measures of physical performance, is an important predictor of cardiovascular outcomes in older adults and declines more rapidly in seniors with hypertension. To date, physical exercise is the primary strategy for attenuating declines in functional status. Yet despite the general benefits of training, exercise alone appears to be insufficient for preventing this decline. Thus, alternative or adjuvant strategies are needed to preserve functional status among seniors with hypertension. Prior data suggest that angiotensin converting enzyme inhibitors (ACEi) may be efficacious in enhancing exercise-derived improvements in functional status yet this hypothesis has not been tested in a randomized controlled trial. The objective of this randomized, double-masked pilot trial is to gather preliminary efficacy and safety data necessary for conducting a full-scale trial to test this hypothesis. Sedentary men and women ≥ 65 years of age with functional limitations and hypertension are being recruited into this 24 week intervention study. Participants are randomly assigned to one of three conditions: (1) ACEi plus exercise training, (2) thiazide diuretic plus exercise training, or (3) AT1 receptor antagonist plus exercise training. The primary outcome is change in walking speed and secondary outcomes consist of other indices of CV risk including exercise capacity, body composition, as well as circulating indices of metabolism, inflammation and oxidative stress. PMID:26115878

Computed Tomographic Window Setting for Bronchial Measurement to Guide Double-Lumen Tube Size.

PubMed

Seo, Jeong-Hwa; Bae, Jinyoung; Paik, Hyesun; Koo, Chang-Hoon; Bahk, Jae-Hyon

2018-04-01

The bronchial diameter measured on computed tomography (CT) can be used to guide double-lumen tube (DLT) sizes objectively. The bronchus is known to be measured most accurately in the so-called bronchial CT window. The authors investigated whether using the bronchial window results in the selection of more appropriately sized DLTs than using the other windows. CT image analysis and prospective randomized study. Tertiary hospital. Adults receiving left-sided DLTs. The authors simulated selection of DLT sizes based on the left bronchial diameters measured in the lung (width 1,500 Hounsfield unit [HU] and level -700 HU), bronchial (1,000 HU and -450 HU), and mediastinal (400 HU and 25 HU) CT windows. Furthermore, patients were randomly assigned to undergo imaging with either the bronchial or mediastinal window to guide DLT sizes. Using the underwater seal technique, the authors assessed whether the DLT was appropriately sized, undersized, or oversized for the patient. On 130 CT images, the bronchial diameter (9.9 ± 1.2 mm v 10.5 ± 1.3 mm v 11.7 ± 1.3 mm) and the selected DLT size were different in the lung, bronchial, and mediastinal windows, respectively (p < 0.001). In 13 patients (17%), the bronchial diameter measured in the lung window suggested too small DLTs (28 Fr) for adults. In the prospective study, oversized tubes were chosen less frequently in the bronchial window than in the mediastinal window (6/110 v 23/111; risk ratio 0.38; 95% CI 0.19-0.79; p = 0.003). No tubes were undersized after measurements in these two windows. The bronchial measurement in the bronchial window guided more appropriately sized DLTs compared with the lung or mediastinal windows. Copyright © 2017 Elsevier Inc. All rights reserved.

The efficacy of Labetalol versus Nitroglycerin for induction of controlled hypotension during sinus endoscopic surgery. A prospective, double-blind and randomized study.

PubMed

El-Shmaa, Nagat S; Ezz, Hoda Alsaid Ahmed; Younes, Ahmed

2017-06-01

To assess the efficacy of labetalol versus nitroglycerin for induction of controlled hypotension during sinus endoscopic surgery. A prospective, double-blind and randomized study. Carried out in operating room in university hospital. 60 patients of both sexes, American Society of Anesthesiologists (ASA) physical status I and II, age range from 20 to 60years; scheduled for elective sinus endoscopic surgery under general anesthesia (GA). Patients were divided into two groups (30 each). NTG group received nitroglycerin infusion at a dose of 2-5μg/kg/min, LAB group received labetalol infusion at a dose of 0.5-2mg/min. Surgical condition was assessed by surgeon using average category scale (ACS) of 0-5, a value of 2-3 being ideal. In both groups mean arterial blood pressure (MAP) was gradually reduced till the ideal ACS for assessment of surgical condition, the target of ACS was 2-3 or lower. Both studied drugs achieved desired hypotension and improved visualization of surgical field by decreasing bleeding in the surgical site, but ideal surgical conditions were created at mild hypotension (MAP 70-75) in LAB group while same conditions were created at MAP of 65-69mmHg in NTG group. Mean heart rate (HR) was significantly higher in NTG group as compared to LAB group. Blood loss decreased significantly in LAB group. Both labetalol and NTG are effective and safe drugs for induction of controlled hypotension during sinus endoscopic surgery. While, labetalol was better as it offered optimum operative condition with mild decrease in blood pressure, decreased surgical bleeding and less tachycardia during the surgery. Copyright © 2017 Elsevier Inc. All rights reserved.

Postoperative endodontic pain of three different instrumentation techniques in asymptomatic necrotic mandibular molars with periapical lesion: a prospective, randomized, double-blind clinical trial.

PubMed

Shokraneh, Ali; Ajami, Majid; Farhadi, Nastaran; Hosseini, Mohsen; Rohani, Bita

2017-01-01

The purpose of this prospective, randomized, double-blind study was to compare postoperative pain of root canal treatment in patients with asymptomatic mandibular molar teeth with necrotic pulp and periapical lesion using three different instrumentation techniques: hand, multi-file rotary (ProTaper Universal), and reciprocating single-file (Wave-One) instrumentation techniques. Ninety-six patients who fulfilled specific inclusion criteria were assigned to three groups according to the root canal instrumentation technique used: Hand (G1), ProTaper Universal (G2), and Wave-One (G3). One-visit root canal treatment was carried out, and the severity of the postoperative pain was assessed by the Heft-Parker visual analogue scale 6, 12, 18, 24, 48, and 72 h after treatment. Data were analyzed by Kruskal-Wallis, χ 2 , Cochrane Q, one-way ANOVA, and Spearman's correlation analyses (α = 0.05). The patients in group 3 reported significantly lower postoperative pain levels at 6, 12, and 18 h compared with the patients in the two other groups (P < .05). In addition, the patients in group 2 reported significantly lower postoperative pain levels at 6 and 12 h compared with the patients in group 1 (P < .05). There were no significant differences in postoperative pain between the three groups at other time intervals (P > .05). The analgesic consumption was significantly higher in group 1 (P < .05), but no difference was seen between the two other groups (P > .05). Postoperative pain was significantly lower in patients undergoing root canal instrumentation with the Wave-One file compared with the ProTaper Universal and hand files.

The 2012 Chitranjan Ranawat award: intraarticular analgesia after TKA reduces pain: a randomized, double-blinded, placebo-controlled, prospective study.

PubMed

Goyal, Nitin; McKenzie, James; Sharkey, Peter F; Parvizi, Javad; Hozack, William J; Austin, Matthew S

2013-01-01

Postoperative pain after total knee arthroplasty remains one of the most important challenges facing patients undergoing this surgery. Providing a balance of adequate analgesia while limiting the functional impact of regional anesthesia and minimizing opioid side effects is critical to minimize adverse events and improve patient satisfaction. We asked whether bupivacaine delivered through an elastomeric device decreases the (1) patients' perception of pain after TKA; (2) narcotic consumption; and (3) narcotic-related side effects as compared with a placebo. In this prospective, double-blind, placebo-controlled study, all patients received standardized regional anesthesia, a preemptive and multimodal analgesic protocol, and a continuous intraarticular infusion at 5 mL/hour through an elastomeric infusion pump. The patients were randomized to receive either an infusion pump filled with (1) 300 mL of 0.5% bupivacaine, the experimental group (n = 75); or (2) 300 mL of 0.9% normal saline solution, the control group (n = 75). Data concerning postoperative pain levels through a visual analog scale, postoperative opioid consumption, opioid-related side effects, and complications were collected and analyzed. Patients in the experimental group receiving the bupivacaine reported a reduction in pain levels in highest, lowest, and current visual analog scale scores compared with the placebo group on the first postoperative day and highest visual analog scale score on postoperative Day 2 along with a 33% reduction in opioid consumption on postoperative Day 2 and a 54% reduction on postoperative Day 3. In patients undergoing TKA, continuous intraarticular analgesia provided an effective adjunct for pain relief in the immediate postoperative period without the disadvantages encountered with other analgesic methods.

Prospective, randomized, double-blinded comparison of the effects of caudally administered levobupivacaine 0.25% and bupivacaine 0.25% on pain and motor block in children undergoing circumcision surgery.

PubMed

Kaya, Z; Süren, M; Arici, S; Karaman, S; Tapar, H; Erdemir, F

2012-12-01

Caudal anesthesia is widely used as intraoperative and postoperative analgesia in children's subumbilical surgeries such as on the urogenital system, lower extremities and lower abdomen to reduce the stress response to surgery and to facilitate the general anesthesia. The purpose of this study was to compare the effects of caudally administered bupivacaine and levobupivacaine of equal volume and concentration on motor block and postoperative pain in children undergoing circumcision surgery. The prospective, randomized, double-blind study included 60 patients with ages ranging from 1-10 years and ASA (American Society of Anesthesiologists) physical status of I-II who underwent elective circumcision surgery. The patients were divided into two groups: group B received 0.5 ml/kg of bupivacaine 0.25% caudally and group L received 0.5 ml/kg of levobupivacaine 0.25% caudally. Postoperative pain was assessed by children's and infant's postoperative pain scale and motor block was assessed by the Bromage scale. The mean children's and infant's postoperative pain scale of group B was significantly lower than that of group L (p < 0.001). Three patients in group B and seven patients in group L needed additional analgesia after the incision. There was no significant difference between groups in terms of Bromage scores and in both groups the residual motor block was found to be zero at the 150th minutes. According to these findings, bupivacaine has an adequate quality of analgesia than levobupivacaine. We suggest that bupivacaine for caudal block at the concentration of 0.25% (0.5 ml/kg) provides an adequate level of analgesia for outpatient circumcision surgery.

Real-time detection of gastric insufflation related to facemask pressure-controlled ventilation using ultrasonography of the antrum and epigastric auscultation in nonparalyzed patients: a prospective, randomized, double-blind study.

PubMed

Bouvet, Lionel; Albert, Marie-Laure; Augris, Caroline; Boselli, Emmanuel; Ecochard, René; Rabilloud, Muriel; Chassard, Dominique; Allaouchiche, Bernard

2014-02-01

The authors sought to determine the level of inspiratory pressure minimizing the risk of gastric insufflation while providing adequate pulmonary ventilation. The primary endpoint was the increase in incidence of gastric insufflation detected by ultrasonography of the antrum while inspiratory pressure for facemask pressure-controlled ventilation increased from 10 to 25 cm H2O. In this prospective, randomized, double-blind study, patients were allocated to one of the four groups (P10, P15, P20, and P25) defined by the inspiratory pressure applied during controlled-pressure ventilation: 10, 15, 20, and 25 cm H2O. Anesthesia was induced using propofol and remifentanil; no neuromuscular-blocking agent was administered. Once loss of eyelash reflex occurred, facemask ventilation was started for a 2-min period while gastric insufflation was detected by auscultation and by real-time ultrasonography of the antrum. The cross-sectional antral area was measured using ultrasonography before and after facemask ventilation. Respiratory parameters were recorded. Sixty-seven patients were analyzed. The authors registered statistically significant increases in incidences of gastric insufflation with inspiratory pressure, from 0% (group P10) to 41% (group P25) according to auscultation, and from 19 to 59% according to ultrasonography. In groups P20 and P25, detection of gastric insufflation by ultrasonography was associated with a statistically significant increase in the antral area. Lung ventilation was insufficient for group P10. Inspiratory pressure of 15 cm H2O allowed for reduced occurrence of gastric insufflation with proper lung ventilation during induction of anesthesia with remifentanil and propofol in nonparalyzed and nonobese patients. (Anesthesiology 2014; 120:326-34).

Ultrasound-guided transversus abdominis plane block for postoperative analgesia in living liver donors: A prospective, randomized, double-blinded clinical trial.

PubMed

Kıtlık, Arzu; Erdogan, Mehmet Ali; Ozgul, Ulku; Aydogan, Mustafa Said; Ucar, Muharrem; Toprak, Huseyin Ilksen; Colak, Cemil; Durmus, Mahmut

2017-02-01

Transversus abdominis plane (TAP) block is a peripheral nerve block that reduces postoperative pain, nausea, vomiting and the need for postoperative opioids following various types of abdominal surgery. The primary aim of the present study was to evaluate the effects of TAP block on postoperative analgesia and opioid consumption in living liver donors in whom a right "J" abdominal incision was used. This prospective, double-blinded, randomized controlled study was conducted with 50 living liver donors, aged 18-65years, who were scheduled to undergo right hepatectomy. Patients who received ultrasonography-guided subcostal TAP block were allocated into Group 1, and patients who did not receive TAP block were allocated into Group 2. The TAP blocks were performed bilaterally at the conclusion of surgery using 1.5mg∗kg -1 bupivacaine diluted with saline to reach a total volume of 40mL. For each patient, morphine consumption, pain scores at rest and movement, sedation scores, nausea, vomiting and the need for antiemetic medication were assessed at 0, 2, 4, 6, 12 and 24h postoperatively by researchers who were blinded to the study groups. Morphine consumption was significantly lower in Group 1 than in Group 2 at the 2nd, 6th and 24th hours (P<0.05). The mean total morphine consumption values after 24h were 40mg and 65mg in Groups 1 and 2, respectively. The TAP block significantly reduced postoperative visual analog scale pain scores both at rest and during movement at 0, 2, 4, 6, and 24h postoperatively (P<0.05). The TAP block reduced 24-h postoperative morphine consumption and contributed to analgesia in living liver donors who underwent upper abdominal wall incisions. Copyright © 2016 Elsevier Inc. All rights reserved.

Operative correction of abdominal rectus diastasis (ARD) reduces pain and improves abdominal wall muscle strength: A randomized, prospective trial comparing retromuscular mesh repair to double-row, self-retaining sutures.

PubMed

Emanuelsson, Peter; Gunnarsson, Ulf; Dahlstrand, Ursula; Strigård, Karin; Stark, Birgit

2016-11-01

The primary aim of this prospective, randomized, clinical, 2-armed trial was to evaluate the risk for recurrence using 2 different operative techniques for repair of abdominal rectus diastasis. Secondary aims were comparison of pain, abdominal muscle strength, and quality of life and to compare those outcomes to a control group receiving physical training only. Eighty-six patients were enrolled. Twenty-nine patients were allocated to retromuscular polypropylene mesh and 27 to double-row plication with Quill technology. Thirty-two patients participated in a 3-month training program. Diastasis was evaluated with computed tomography scan and clinically. Pain was assessed using the ventral hernia pain questionnaire, a quality-of-life survey, SF-36, and abdominal muscle strength using the Biodex System-4. One early recurrence occurred in the Quill group, 2 encapsulated seromas in the mesh group, and 3 in the suture group. Significant improvements in perceived pain, the ventral hernia pain questionnaire, and quality of life appeared at the 1-year follow-up with no difference between the 2 operative groups. Significant muscular improvement was obtained in all groups (Biodex System-4). Patient perceived gain in muscle strength assessed with a visual analog scale improved similarly in both operative groups. This improvement was significantly greater than that seen in the training group. Patients in the training group still experienced bodily pain at follow-up. There was no difference between the Quill technique and retromuscular mesh in the effect on abdominal wall stability, with a similar complication rate 1 year after operation. An operation improves functional ability and quality of life. Training strengthens the abdominal muscles, but patients still experience discomfort and pain. Copyright © 2016 Elsevier Inc. All rights reserved.

A prospective double-blinded randomized controlled trial comparing systemic stress response in Laparoascopic cholecystectomy between low-pressure and standard-pressure pneumoperitoneum.

PubMed

Shoar, Saeed; Naderan, Mohammad; Ebrahimpour, Hossein; Soroush, Ahmadreza; Nasiri, Shirzad; Movafegh, Ali; Khorgami, Zhamak

2016-04-01

Laparoscopic cholecystectomy (LC) has become the gold-standard treatment for gallstone diseases. However, despite huge reduction in operative injury, systemic stress response remains high. This randomized controlled trial (RCT) aimed to compare systemic stress response between 2 different techniques of CO2 pneumoperitoneum. Trough a prospective, double-blinded RCT, serum levels of cortisol, adrenaline, glucose, and C-reactive protein (CRP) were compared between the two groups consisted of 50 patients undergoing LC under low-pressure and standard-pressure CO2 pneimoperitoneum. A total of fifty patients undergoing LC were equally assigned to 2 groups of twenty five patients. Average age was 48 ± 13.8 years (range, 19-74 years). Operative time was similar between standard-pressure group (47.8 ± 16.8 min) and low-pressure group (53.6 ± 25.1). Moreover, intra-operative IV volume administration and urine output did not differ significantly between the 2 groups (p > 0.05). Although the average heart rate and mean arterial pressure were slightly higher in a standard-pressure group compared with a low-pressure group, serial measurements of these parameters were statistically similar between the 2 groups. Serial changes of serum levels of cortisol, glucose, adrenaline, and CRP were compared between surgery day, postoperative 6-h and 1st postoperative day, which did not differ significantly between the standard-pressure and the low-pressure groups (p > 0.05). Our study did not reveal any alteration in systemic stress response with reduction in intra-abdominal pressure of pneumoperitoneum in LC. RCT REGISTRATION: irct.ir ID: IRCT201110072982N5. Copyright © 2016 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

Effect of an orally formulated processed black cumin, from Iranian traditional medicine pharmacopoeia, in relieving symptoms of knee osteoarthritis: A prospective, randomized, double-blind and placebo-controlled clinical trial.

PubMed

Salimzadeh, Ahmad; Ghourchian, Anahita; Choopani, Rasool; Hajimehdipoor, Homa; Kamalinejad, Mohammad; Abolhasani, Maryam

2017-06-01

Osteoarthritis is a global health problem, especially for the elderly. A good replacement for non-surgical treatments is the use of traditional medicines. We selected a revere plant (Nigella sativa L.), a widely utilized medicinal herb for the treatment of inflammatory conditions, from the Iranian traditional medicine (ITM) pharmacopoeia with proven anti-inflammatory and analgesic actions. We performed a prospective, randomized, double-blind, and placebo-controlled clinical trial, in order to investigate whether the herb is useful in alleviating the symptoms of knee osteoarthritis. American College of Rheumatology clinical criteria were the basis of diagnosis, while the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire was considered as the main outcome measure. One hundred and ten eligible patients were assigned to receive a placebo or an active intervention (2 g/day of processed N. sativa seed powder in divided doses). Acetaminophen tablets were the rescue medicine. Finally, 40 patients in the placebo group and 37 patients in the active group completed the trial and were included in the statistical analysis. Both cohorts demonstrated statistically significant within-group differences (P < 0.05) in some subscales that were more prominent in the active group without any considerable adverse effects. Nevertheless, KOOS score results and the mean number of acetaminophen tablets used by patients showed no statistically significant between-group differences. It can be concluded that future programmed studies with larger sample sizes, longer follow-up periods, and other forms of N. sativa seeds as an active intervention is necessary to evaluate its efficacy in relieving the symptoms of knee osteoarthritis. © 2017 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.

Economic Impact of Ketorolac vs Corticosteroid Intra-Articular Knee Injections for Osteoarthritis: A Randomized, Double-Blind, Prospective Study.

PubMed

Bellamy, Jaime L; Goff, Brandon J; Sayeed, Siraj A

2016-09-01

Knee osteoarthritis is a disabling disease that costs billions of dollars to treat. Corticosteroid gives varying pain relief and costs $12 per injection, whereas ketorolac costs $2 per injection, per institutional costs. The aim of this study was to compare ketorolac with corticosteroid based on pain relief using patient outcome measures and cost data. A total of 35 patients were randomized to ketorolac or corticosteroid intra-articular knee injection in a double-blind, prospective study. Follow-up was 24 weeks. Osteoarthritis was evaluated using Kellgren-Lawrence grading. Visual analog scale (VAS) was the primary outcome measure. A query of the institutional database was performed for International Classification of Diseases, Ninth Revision codes 715.16 and 719.46, and procedure code 20610 over a 3-year period. Two-way, repeated measures analysis of variance and Spearman rank correlation were used for statistical analysis. Mean VAS for ketorolac and corticosteroid decreased significantly from baseline at 2 weeks, 6.3-4.6 and 5.2-3.6, respectively and remained decreased for 24 weeks. There was no correlation between VAS and demographics within treatments. There were 220, 602, and 405 injections performed on patients with the International Classification of Diseases, Ninth Revision codes 715.16 and 719.46 during 2013, 2014, and 2015, respectively. The cost savings per year using ketorolac instead of corticosteroid would be $2259.40, $6182.54, and $4159.35 for 2013, 2014, and 2015, respectively, with a total savings of $12,601.29 over this period. Pain relief was similar between ketorolac and corticosteroid injections. Ketorolac knee injection is safe and effective with a cost savings percentage difference of 143% when compared with corticosteroid. Copyright © 2016 Elsevier Inc. All rights reserved.

Automatic Masking for Robust 3D-2D Image Registration in Image-Guided Spine Surgery.

PubMed

Ketcha, M D; De Silva, T; Uneri, A; Kleinszig, G; Vogt, S; Wolinsky, J-P; Siewerdsen, J H

During spinal neurosurgery, patient-specific information, planning, and annotation such as vertebral labels can be mapped from preoperative 3D CT to intraoperative 2D radiographs via image-based 3D-2D registration. Such registration has been shown to provide a potentially valuable means of decision support in target localization as well as quality assurance of the surgical product. However, robust registration can be challenged by mismatch in image content between the preoperative CT and intraoperative radiographs, arising, for example, from anatomical deformation or the presence of surgical tools within the radiograph. In this work, we develop and evaluate methods for automatically mitigating the effect of content mismatch by leveraging the surgical planning data to assign greater weight to anatomical regions known to be reliable for registration and vital to the surgical task while removing problematic regions that are highly deformable or often occluded by surgical tools. We investigated two approaches to assigning variable weight (i.e., "masking") to image content and/or the similarity metric: (1) masking the preoperative 3D CT ("volumetric masking"); and (2) masking within the 2D similarity metric calculation ("projection masking"). The accuracy of registration was evaluated in terms of projection distance error (PDE) in 61 cases selected from an IRB-approved clinical study. The best performing of the masking techniques was found to reduce the rate of gross failure (PDE > 20 mm) from 11.48% to 5.57% in this challenging retrospective data set. These approaches provided robustness to content mismatch and eliminated distinct failure modes of registration. Such improvement was gained without additional workflow and has motivated incorporation of the masking methods within a system under development for prospective clinical studies.

Automatic masking for robust 3D-2D image registration in image-guided spine surgery

NASA Astrophysics Data System (ADS)

Ketcha, M. D.; De Silva, T.; Uneri, A.; Kleinszig, G.; Vogt, S.; Wolinsky, J.-P.; Siewerdsen, J. H.

2016-03-01

During spinal neurosurgery, patient-specific information, planning, and annotation such as vertebral labels can be mapped from preoperative 3D CT to intraoperative 2D radiographs via image-based 3D-2D registration. Such registration has been shown to provide a potentially valuable means of decision support in target localization as well as quality assurance of the surgical product. However, robust registration can be challenged by mismatch in image content between the preoperative CT and intraoperative radiographs, arising, for example, from anatomical deformation or the presence of surgical tools within the radiograph. In this work, we develop and evaluate methods for automatically mitigating the effect of content mismatch by leveraging the surgical planning data to assign greater weight to anatomical regions known to be reliable for registration and vital to the surgical task while removing problematic regions that are highly deformable or often occluded by surgical tools. We investigated two approaches to assigning variable weight (i.e., "masking") to image content and/or the similarity metric: (1) masking the preoperative 3D CT ("volumetric masking"); and (2) masking within the 2D similarity metric calculation ("projection masking"). The accuracy of registration was evaluated in terms of projection distance error (PDE) in 61 cases selected from an IRB-approved clinical study. The best performing of the masking techniques was found to reduce the rate of gross failure (PDE > 20 mm) from 11.48% to 5.57% in this challenging retrospective data set. These approaches provided robustness to content mismatch and eliminated distinct failure modes of registration. Such improvement was gained without additional workflow and has motivated incorporation of the masking methods within a system under development for prospective clinical studies.

Rule of Thumb Proposing the Size of Aperture Expected to be Sufficient to Resolve Double Stars with Given Parameters

NASA Astrophysics Data System (ADS)

Knapp, Wilfried

2018-01-01

Visual observation of double stars is an anachronistic passion especially attractive for amateurs looking for sky objects suitable for visual observation even in light polluted areas. Session planning then requires a basic idea which objects might be suitable for a given equipment—this question is a long term issue for visual double star observers and obviously not easy to answer, especially for unequal bright components. Based on a reasonably large database with limited aperture observations (done with variable aperture equipment iris diaphragm or aperture masks) a heuristic approach is used to derive a statistically well founded Rule of Thumb formula.

Efficacy of Tamsulosin, Oxybutynin, and their combination in the control of double-j stent-related lower urinary tract symptoms.

PubMed

Maldonado-Avila, Miguel; Garduno-Arteaga, Leopoldo; Jungfermann-Guzman, Rene; Manzanilla-Garcia, Hugo A; Rosas-Nava, Emmanuel; Procuna-Hernandez, Nestor; Vela-Mollinedo, Alejandro; Almazan-Trevino, Luis; Guzman-Esquivel, Jose

2016-01-01

Indwelling double J ureteral stents are used routinely in the resolution of ureteral obstruction caused by different etiologies. Evaluation of urinary symptoms related to double-J stent, indicate that these affect 73-90% of patients. We conducted a prospective, randomized study, to evaluate the efficacy of tamsulosin, oxybutinin and combination therapy in improving the urinary symptoms. Patients who underwent ureteral stent placement after ureterolithotripsy (total 51), were randomized into three groups: Group I: Tamsulosin 0.4 mg. Once per day(17 patients), Group II: Oxybutinin 5 mg. once per day (17 patients), Group III: Tamsulosin+ oxybutynin once per day (17 patients). All the groups received the drugs for three weeks and completed a Spanish validated Ureteral Stent Symptom Questionnaire (USSQ) at day 7 and 21. Repeated measures ANOVA showed mean urinary symptom index score was 22.3 vs. 15.5 in group three (p<0.001) at day 7 and 21 respectively. The mean work performance index was 6.6 vs 8.1 (p=0.049) favoring tamsulosin group, the mean sexual score was 0.5 vs 1.5 (p=0.03). Among additional problems the mean was 7.2 vs 6.2 (p=0.03). No significant difference was noted among pain and general health index. No side effects were reported. Combination therapy with tamsulosin and oxybutynin improved irritative symptoms and work performance as well as sexual matters. Combination therapy should be considered for patients who complained of stent related symptoms.

Optical noise-free image encryption based on quick response code and high dimension chaotic system in gyrator transform domain

NASA Astrophysics Data System (ADS)

Sui, Liansheng; Xu, Minjie; Tian, Ailing

2017-04-01

A novel optical image encryption scheme is proposed based on quick response code and high dimension chaotic system, where only the intensity distribution of encoded information is recorded as ciphertext. Initially, the quick response code is engendered from the plain image and placed in the input plane of the double random phase encoding architecture. Then, the code is encrypted to the ciphertext with noise-like distribution by using two cascaded gyrator transforms. In the process of encryption, the parameters such as rotation angles and random phase masks are generated as interim variables and functions based on Chen system. A new phase retrieval algorithm is designed to reconstruct the initial quick response code in the process of decryption, in which a priori information such as three position detection patterns is used as the support constraint. The original image can be obtained without any energy loss by scanning the decrypted code with mobile devices. The ciphertext image is the real-valued function which is more convenient for storing and transmitting. Meanwhile, the security of the proposed scheme is enhanced greatly due to high sensitivity of initial values of Chen system. Extensive cryptanalysis and simulation have performed to demonstrate the feasibility and effectiveness of the proposed scheme.

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

Goldman, Allen M.

The goal of this program was to study new physical phenomena that might be relevant to the performance of conductive devices and circuits of the smallest realizable feature sizes possible using physical rather than biological techniques. Although the initial scientific work supported involved the use of scanning tunneling microscopy and spectroscopy to ascertain the statistics of the energy level distribution of randomly sized and randomly shaped quantum dots, or nano-crystals, the main focus was on the investigation of selected properties, including superconductivity, of conducting and superconducting nanowires prepared using electron-beam-lithography. We discovered a magnetic-field-restoration of superconductivity in out-of-equilibrium nanowires drivenmore » resistive by current. This phenomenon was explained by the existence of a state in which dissipation coexisted with nonvanishing superconducting order. We also produced ultra-small superconducting loops to study a predicted anomalous fluxoid quantization, but instead, found a magnetic-field-dependent, high-resistance state, rather than superconductivity. Finally, we developed a simple and controllable nanowire in an induced charged layer near the surface of a masked single-crystal insulator, SrTiO 3. The layer was induced using an electric double layer transistor employing an ionic liquid (IL). The transport properties of the induced nanowire resembled those of collective electronic transport through an array of quantum dots.« less

Clinical evaluation of endometriosis and differential response to surgical therapy with and without application of Oxiplex/AP* adhesion barrier gel.

PubMed

diZerega, Gere S; Coad, James; Donnez, Jacques

2007-03-01

To correlate parameters of endometriosis obtained during routine clinical evaluation with the subsequent formation of adhesions following surgical treatment by laparoscopy. Randomized, controlled, double-blind, clinical trial. Tertiary referral centers for the treatment of endometriosis. Thirty-seven patients (65 with adnexa) with stage I-III endometriosis; endometrioma-only patients were excluded. Laparoscopic surgical treatment of endometriosis, followed by randomization to Oxiplex/AP (FzioMed, Inc., San Luis Obispo, California) gel treatment (treated group) of adnexa, or surgery alone (control group); follow-up laparoscopy 6-10 weeks later. Adnexal Americn Fertility Society score, correlated with color and location of endometriosis, as well as stage of disease determined by masked review of videotapes. Control patients with at least 50% red lesions had a greater increase in ipsilateral adnexal adhesion scores than patients with mostly black or white and/or clear lesions. Treated patients with red lesions had a greater decrease in adnexal adhesion scores than control patients. There was a correlation between baseline endometriosis stage and postoperative adhesion formation in control patients, but not treated patients. Patients with red endometriotic lesions had greater increases in their adhesion scores than patients with only black, white, and/or clear lesions. Oxiplex/AP gel was effective in reducing adhesions, compared to surgery alone, in all groups.