Comparative short-term effects of two thoracic spinal manipulation techniques in subjects with chronic mechanical neck pain: a randomized controlled trial.

Science.gov (United States)

Casanova-Méndez, Amaloha; Oliva-Pascual-Vaca, Angel; Rodriguez-Blanco, Cleofás; Heredia-Rizo, Alberto Marcos; Gogorza-Arroitaonandia, Kristobal; Almazán-Campos, Ginés

2014-08-01

Spinal Manipulation (SM) has been purported to decrease pain and improve function in subjects with non-specific neck pain. Previous research has investigated which individuals with non-specific neck pain will be more likely to benefit from SM. It has not yet been proven whether or not the effectiveness of thoracic SM depends on the specific technique being used. This double-blind randomized trial has compared the short-term effects of two thoracic SM maneuvers in subjects with chronic non-specific neck pain. Sixty participants were distributed randomly into two groups. One group received the Dog technique (n = 30), with the subject in supine position, and the other group underwent the Toggle-Recoil technique (n = 30), with the participant lying prone, T4 being the targeted area in both cases. Evaluations were made of self-reported neck pain (Visual Analogue Scale); neck mobility (Cervical Range of Motion); and pressure pain threshold at the cervical and thoracic levels (C4 and T4 spinous process) and over the site described for location of tense bands of the upper trapezius muscle. Measurements were taken before intervention, immediately afterward, and 20 min later. Both maneuvers improved neck mobility and mechanosensitivity and reduced pain in the short term. No major or clinical differences were found between the groups. In the between-groups comparison slightly better results were observed in the Toggle-Recoil group only for cervical extension (p = 0.009), right lateral flexion (p = 0.004) and left rotation (p < 0.05). Copyright © 2014 Elsevier Ltd. All rights reserved.

Blood glucose control in healthy subject and patients receiving intravenous glucose infusion or total parenteral nutrition using glucagon-like peptide 1

DEFF Research Database (Denmark)

Nauck, Michael A; Walberg, Jörg; Vethacke, Arndt

2004-01-01

It was the aim of the study to examine whether the insulinotropic gut hormone GLP-1 is able to control or even normalise glycaemia in healthy subjects receiving intravenous glucose infusions and in severely ill patients hyperglycaemic during total parenteral nutrition.......It was the aim of the study to examine whether the insulinotropic gut hormone GLP-1 is able to control or even normalise glycaemia in healthy subjects receiving intravenous glucose infusions and in severely ill patients hyperglycaemic during total parenteral nutrition....

Exact closed form expressions for outage probability of GSC receivers over Rayleigh fading channel subject to self-interference

KAUST Repository

Nam, Sungsik

2010-11-01

Previous work on performance analyses of generalized selection combining (GSC) RAKE receivers based on the signal to noise ratio focused on the development of methodologies to derive exact closed-form expressions for various performance measures. However, some open problems related to the performance evaluation of GSC RAKE receivers still remain to be solved such that an assessment of the impact of self-interference on the performance of GSC RAKE receivers. To have a full and exact understanding of the performance of GSC RAKE receivers, the outage probability of GSC RAKE receivers needs to be analyzed as closed-form expressions. The major difficulty in this problem is to derive some joint statistics of ordered exponential variates. With this motivation in mind, we capitalize in this paper on some new order statistics results to derive exact closed-form expressions for outage probability of GSC RAKE receivers subject to self-interference over independent and identically distributed Rayleigh fading channels. © 2010 IEEE.

Exact closed form expressions for outage probability of GSC receivers over Rayleigh fading channel subject to self-interference

KAUST Repository

Nam, Sungsik; Hasna, Mazen Omar; Alouini, Mohamed-Slim

2010-01-01

in mind, we capitalize in this paper on some new order statistics results to derive exact closed-form expressions for outage probability of GSC RAKE receivers subject to self-interference over independent and identically distributed Rayleigh fading

Drinking Water to Prevent Postvaccination Presyncope in Adolescents: A Randomized Trial.

Science.gov (United States)

Kemper, Alex R; Barnett, Elizabeth D; Walter, Emmanuel B; Hornik, Christoph; Pierre-Joseph, Natalie; Broder, Karen R; Silverstein, Michael; Harrington, Theresa

2017-11-01

Postvaccination syncope can cause injury. Drinking water prephlebotomy increases peripheral vascular tone, decreasing risk of blood-donation presyncope and syncope. This study evaluated whether drinking water prevaccination reduces postvaccination presyncope, a potential syncope precursor. We conducted a randomized trial of subjects aged 11 to 21 years receiving ≥1 intramuscular vaccine in primary care clinics. Intervention subjects were encouraged to drink 500 mL of water, with vaccination recommended 10 to 60 minutes later. Control subjects received usual care. Presyncope symptoms were assessed with a 12-item survey during the 20-minutes postvaccination. Symptoms were classified with a primary cutoff sensitive for presyncope, and a secondary, more restrictive cutoff requiring greater symptoms. Results were adjusted for clustering by recruitment center. There were 906 subjects randomly assigned to the control group and 901 subjects randomly assigned to the intervention group. None had syncope. Presyncope occurred in 36.2% of subjects by using the primary definition, and in 8.0% of subjects by using the restrictive definition. There were no significant differences in presyncope by intervention group for the primary (1-sided test, P = .24) or restrictive outcome (1-sided test, P = .17). Among intervention subjects vaccinated within 10 to 60 minutes after drinking all 500 mL of water ( n = 519), no reduction in presyncope was observed for the primary or restrictive outcome (1-sided tests, P = .13, P = .17). In multivariable regression analysis, presyncope was associated with younger age, history of passing out or nearly passing out after a shot or blood draw, prevaccination anxiety, receiving >1 injected vaccine, and greater postvaccination pain. Drinking water before vaccination did not prevent postvaccination presyncope. Predictors of postvaccination presyncope suggest opportunities for presyncope and syncope prevention interventions. Copyright © 2017 by the

Color Charts, Esthetics, and Subjective Randomness

Science.gov (United States)

Sanderson, Yasmine B.

2012-01-01

Color charts, or grids of evenly spaced multicolored dots or squares, appear in the work of modern artists and designers. Often the artist/designer distributes the many colors in a way that could be described as "random," that is, without an obvious pattern. We conduct a statistical analysis of 125 "random-looking" art and design color charts and…

A randomized phase II chemoprevention trial of 13-CIS retinoic acid with or without alpha tocopherol or observation in subjects at high risk for lung cancer.

Science.gov (United States)

Kelly, Karen; Kittelson, John; Franklin, Wilbur A; Kennedy, Timothy C; Klein, Catherine E; Keith, Robert L; Dempsey, Edward C; Lewis, Marina; Jackson, Mary K; Hirsch, Fred R; Bunn, Paul A; Miller, York E

2009-05-01

No chemoprevention strategies have been proven effective for lung cancer. We evaluated the effect of 13-cis retinoic acid (13-cis RA), with or without alpha tocopherol, as a lung cancer chemoprevention agent in a phase II randomized controlled clinical trial of adult subjects at high risk for lung cancer as defined by the presence of sputum atypia, history of smoking, and airflow obstruction, or a prior surgically cured nonsmall cell lung cancer (disease free, >3 years). Subjects were randomly assigned to receive either 13-cis RA, 13-cis RA plus alpha tocopherol (13-cis RA/alpha toco) or observation for 12 months. Outcome measures are derived from histologic evaluation of bronchial biopsy specimens obtained by bronchoscopy at baseline and follow-up. The primary outcome measure is treatment "failure" defined as histologic progression (any increase in the maximum histologic score) or failure to return for follow-up bronchoscopy. Seventy-five subjects were randomized (27/22/26 to observations/13-cis RA/13-cis RA/alpha toco); 59 completed the trial; 55 had both baseline and follow-up bronchoscopy. The risk of treatment failure was 55.6% (15 of 27) and 50% (24 of 48) in the observation and combined (13 cis RA plus 13 cis RA/alpha toco) treatment arms, respectively (odds ratio adjusted for baseline histology, 0.97; 95% confidence interval, 0.36-2.66; P = 0.95). Among subjects with complete histology data, maximum histology score in the observation arm increased by 0.37 units and by 0.03 units in the treated arms (difference adjusted for baseline, -0.18; 95% confidence interval, -1.16 to 0.81; P = 0.72). Similar (nonsignificant) results were observed for treatment effects on endobronchial proliferation as assessed by Ki-67 immunolabeling. Twelve-month treatment with 13-cis RA produced nonsignificant changes in bronchial histology, consistent with results in other trials. Agents advancing to phase III randomized trials should produce greater histologic changes. The

A Randomized Phase II Chemoprevention Trial of 13-CIS Retinoic Acid with Or without α Tocopherol or Observation in Subjects at High Risk for Lung Cancer

Science.gov (United States)

Kelly, Karen; Kittelson, John; Franklin, Wilbur A.; Kennedy, Timothy C.; Klein, Catherine E.; Keith, Robert L.; Dempsey, Edward C.; Lewis, Marina; Jackson, Mary K.; Hirsch, Fred R.; Bunn, Paul A.; Miller, York E.

2011-01-01

No chemoprevention strategies have been proven effective for lung cancer. We evaluated the effect of 13-cis retinoic acid (13-cis RA), with or without α tocopherol, as a lung cancer chemoprevention agent in a phase II randomized controlled clinical trial of adult subjects at high risk for lung cancer as defined by the presence of sputum atypia, history of smoking, and airflow obstruction, or a prior surgically cured nonsmall cell lung cancer (disease free, >3 years). Subjects were randomly assigned to receive either 13-cis RA, 13-cis RA plus α tocopherol (13-cis RA/α toco) or observation for 12 months. Outcome measures are derived from histologic evaluation of bronchial biopsy specimens obtained by bronchoscopy at baseline and follow-up. The primary outcome measure is treatment “failure” defined as histologic progression (any increase in the maximum histologic score) or failure to return for follow-up bronchoscopy. Seventy-five subjects were randomized (27/22/26 to obervations/13-cis RA/13-cis RA/α toco); 59 completed the trial; 55 had both baseline and follow-up bronchoscopy. The risk of treatment failure was 55.6% (15 of 27) and 50% (24 of 48) in the observation and combined (13 cis RA plus 13 cis RA/α toco) treatment arms, respectively (odds ratio adjusted for baseline histology, 0.97; 95% confidence interval, 0.36–2.66; P = 0.95). Among subjects with complete histology data, maximum histology score in the observation arm increased by 0.37 units and by 0.03 units in the treated arms (difference adjusted for baseline, −0.18; 95% confidence interval, −1.16 to 0.81; P = 0.72). Similar (nonsignificant) results were observed for treatment effects on endobronchial proliferation as assessed by Ki-67 immunolabeling. Twelve-month treatment with 13-cis RA produced nonsignificant changes in bronchial histology, consistent with results in other trials. Agents advancing to phase III randomized trials should produce greater histologic changes. The addition of �

45 CFR 2553.44 - May cost reimbursements received by a RSVP volunteer be subject to any tax or charge, treated as...

Science.gov (United States)

2010-10-01

... 45 Public Welfare 4 2010-10-01 2010-10-01 false May cost reimbursements received by a RSVP... benefit payments or minimum wage laws. Cost reimbursements are not subject to garnishment, do not reduce... receive assistance from other programs? 2553.44 Section 2553.44 Public Welfare Regulations Relating to...

Vascular effects of intravenous intralipid and dextrose infusions in obese subjects

OpenAIRE

Gosmanov, Aidar R.; Smiley, Dawn D.; Peng, Limin; Siquiera, Joselita; Robalino, Gonzalo; Newton, Christopher; Umpierrez, Guillermo E.

2012-01-01

Hyperglycemia and elevated free fatty acids (FFA) are implicated in the development of endothelial dysfunction. Infusion of soy-bean oil-based lipid emulsion (Intralipid®) increases FFA levels and results in elevation of blood pressure (BP) and endothelial dysfunction in obese healthy subjects. The effects of combined hyperglycemia and high FFA on BP, endothelial function and carbohydrate metabolism are not known. Twelve obese healthy subjects received four random, 8-h IV infusions of saline,...

Tolerability, pharmacokinetics and pharmacodynamics of TA-8995, a selective cholesteryl ester transfer protein (CETP) inhibitor, in healthy subjects

NARCIS (Netherlands)

Ford, John; Lawson, Matt; Fowler, David; Maruyama, Nobuko; Mito, Seiji; Tomiyasu, Koichi; Kinoshita, Shuji; Suzuki, Chisa; Kawaguchi, Atsuhiro; Round, Patrick; Boyce, Malcolm; Warrington, Steve; Weber, Werner; van Deventer, Sander; Kastelein, John J. P.

2014-01-01

Two double-blind, randomized studies were conducted to assess the tolerability, pharmacokinetics and pharmacodynamics of oral TA-8995, a new cholesteryl ester transfer protein (CETP) inhibitor, in healthy subjects. Study 1: Subjects received single doses of TA-8995 or placebo (fasted). Doses were 5,

A randomized nutrition counseling intervention in pediatric leukemia patients receiving steroids results in reduced caloric intake.

Science.gov (United States)

Li, Rhea; Donnella, Hayley; Knouse, Phillip; Raber, Margaret; Crawford, Karla; Swartz, Maria C; Wu, Jimin; Liu, Diane; Chandra, Joya

2017-02-01

Quality of life in survivors of pediatric acute lymphocytic leukemia (ALL) can be compromised by chronic diseases including increased risk of second cancers, cardiovascular disease, and diabetes. Overweight or obesity further increases these risks. Steroids are a component of chemotherapy for ALL, and weight gain is a common side effect. To impact behaviors associated with weight gain, we conducted a randomized nutrition counseling intervention in ALL patients on treatment. ALL patients on a steroid-based treatment regimen at the MD Anderson Children's Cancer Hospital were recruited and randomized into control or intervention groups. The control group received standard care and nutrition education materials. The intervention group received monthly one-on-one nutrition counseling sessions, consisting of a baseline and 12 follow-up visits. Anthropometrics, dietary intake (3-day 24-hr dietary recalls) and oxidative stress measures were collected at baseline, 6 months, and postintervention. Dietary recall data were analyzed using the Nutrition Data System for Research. Twenty-two patients (median age 11.5 years), all in the maintenance phase of treatment, were recruited. The intervention group (n = 12) reported significantly lower calorie intake from baseline to 12-month follow-up and significant changes in glutamic acid and selenium intake (P < 0.05). Waist circumference was significantly associated with calorie, vitamin E, glutamic acid, and selenium intake. A year-long dietary intervention was effective at reducing caloric intake in pediatric ALL patients receiving steroid-based chemotherapy, indicating that this is a modality that can be built upon for obesity prevention and management. © 2016 Wiley Periodicals, Inc.

Housing First improves subjective quality of life among homeless adults with mental illness: 12-month findings from a randomized controlled trial in Vancouver, British Columbia.

Science.gov (United States)

Patterson, Michelle; Moniruzzaman, Akm; Palepu, Anita; Zabkiewicz, Denise; Frankish, Charles J; Krausz, Michael; Somers, Julian M

2013-08-01

This study used an experimental design to examine longitudinal changes in subjective quality of life (QoL) among homeless adults with mental illness after assignment to different types of supported housing or to treatment as usual (TAU, no housing or supports through the study). We hypothesized that subjective QoL would improve over time among participants assigned to supported housing as compared to TAU, regardless of the type of supported housing received or participants' level of need. Participants (n = 497) were stratified by level of need ("high" or "moderate") and randomly assigned to Housing First (HF) in scattered-site apartments, HF in a congregate setting (high needs only), or TAU. Linear mixed-effects regression was used to model the association between study arm and self-reported QoL at baseline and at 6 and 12 months post-baseline by need level. Based on the adjusted overall score on the QoL measure, participants randomized to HF reported significantly greater overall QoL as compared to TAU, regardless of need level or type of supported housing at both 6 and 12 months post-baseline. Scores on the safety and living situation subscales were significantly greater for both high and moderate need participants assigned to supported housing regardless of type at both 6 and 12 months post-baseline as compared to TAU. Despite multiple health and social challenges faced by homeless individuals with mental illness, HF in both scattered-site and congregate models results in significantly greater perceived QoL as compared to individuals who do not receive HF even after a relatively short period of time.

The Agreement between the MMSE and IQCODE Tests in a Community-Based Sample of Subjects Aged 70 Years or Older Receiving In-Home Nursing: An Explorative Study

Directory of Open Access Journals (Sweden)

Øyvind Kirkevold

2015-02-01

Full Text Available Aim: It was the aim of this study to compare the Mini-Mental State Examination (MMSE with the Informant Questionnaire for Cognitive Decline in the Elderly (IQCODE and to explore the characteristics of subjects with possible dementia with only one of the two tools. Methods: We used a random sample of patients aged 70+ receiving social service or in-home nursing. The patients were tested with the MMSE, and the next of kin was interviewed using the following: the IQCODE, the Cornell Scale for Depression in Dementia (CSDD, the Neuropsychiatric Inventory (NPI, instrumental activities of daily living (IADL, personal ADL (PADL and the General Medical Health Rating (GMHR. Results: Subjects with dementia defined only according to the MMSE showed a pattern of scores on IADL, PADL, CSDD, NPI-10 and GMHR similar to the no-dementia group according to both the MMSE and the IQCODE. Those with dementia defined only according to the IQCODE showed a pattern of scores similar to the possible dementia group according to both the MMSE and the IQCODE.

Effects of Curcuminoids-Piperine Combination on Systemic Oxidative Stress, Clinical Symptoms and Quality of Life in Subjects with Chronic Pulmonary Complications Due to Sulfur Mustard: A Randomized Controlled Trial.

Science.gov (United States)

Panahi, Yunes; Ghanei, Mostafa; Hajhashemi, Ali; Sahebkar, Amirhossein

2016-01-01

Oxidative stress plays a key role in the development of chronic pulmonary complications of sulfur mustard (SM). Curcuminoids are polyphenols with documented safety and antioxidant activity. The present study aimed to investigate the efficacy of short-term supplementation with curcuminoids (co-administered with piperine to enhance the bioavailability of curcuminoids) in alleviating systemic oxidative stress and clinical symptoms, and improvement of health-related quality of life (HRQoL) in subjects suffering from chronic pulmonary complications due to SM exposure who are receiving standard respiratory treatments. Eighty-nine subjects were recruited to this randomized double-blind placebo-controlled trial, being randomly allocated to either curcuminoids (1500 mg/day) + piperine (15 mg/day) combination (n = 45) or placebo (n = 44) for a period of 4 weeks. High-resolution computed tomography suggested the diagnosis of bronchiolitis obliterans in all subjects. Efficacy measures were changes in serum levels of reduced glutathione (GSH) and malonedialdehyde (MDA). The severity and frequency of respiratory symptoms and HRQoL were also assessed using St. George respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT) indices. Serum levels of GSH were increased whilst those of MDA decreased by the end of trial in both groups. Likewise, there were significant improvements in the total as well as subscale (symptoms, activity and impact) SGRQ and CAT scores in both groups. However, comparison of magnitude of changes revealed a greater effect of curcuminoids-piperine combination compared to placebo in elevating GSH, reducing MDA and improving CAT and SGRQ (total and subscale) scores (p stress, clinical symptoms and HRQoL, these phytochemicals may be used as safe adjuvants in patients suffering from chronic SM-induced pulmonary complications who are receiving standard treatments.

A Randomized, Double-Blind Study Assessing Changes in Cognitive Function in Indian School Children Receiving a Combination of Bacopa monnieri and Micronutrient Supplementation vs. Placebo

Directory of Open Access Journals (Sweden)

Tora Mitra-Ganguli

2017-11-01

Full Text Available Several studies have indicated a chronic cognitive enhancing effect of Bacopa monnieri across different ages and cognitive impairment associated with vitamin and mineral deficiencies in children. Therefore, we investigated the effects of 4-month supplementation with a combination of B. monnieri extract and multiple micronutrients on cognitive functions in Indian school children aged 7–12 years. This was a randomized, double-blind, parallel design, single-center study in which 300 children were randomized to receive a beverage either fortified with B. monnieri and multiple micronutrients (“fortified” or a non-fortified isocaloric equivalent (“control” twice-daily for 4 months. Cognitive function was assessed by the Cambridge Neuropsychological Automated Test Battery (CANTAB administered at baseline, Day 60 and Day 121. The primary endpoint was change in short-term memory (working memory from baseline in subjects receiving “fortified” vs. “control” beverages after 4 months. Secondary endpoints included sustained attention, episodic memory, and executive function. The “fortified” beverage did not significantly improve short-term memory or any of the secondary outcomes tested relative to the “control” beverage. However, the spatial working memory “strategy” score showed significant improvement on Day 60 (difference between groups in change from baseline: −0.55; p < 0.05, but not on Day 121 due to the active intervention. Study products were well-tolerated. Reasons for these unexpected findings are discussed.

A Randomized Controlled Trial of Lorazepam to Reduce Liver Motion in Patients Receiving Upper Abdominal Radiation Therapy

Energy Technology Data Exchange (ETDEWEB)

Tsang, Derek S.; Voncken, Francine E.M.; Tse, Regina V. [Princess Margaret Cancer Centre, University Health Network, Department of Radiation Oncology, University of Toronto, Toronto (Canada); Sykes, Jenna [Department of Biostatistics, Princess Margaret Cancer Centre, University Health Network, Toronto (Canada); Wong, Rebecca K.S.; Dinniwell, Rob E.; Kim, John; Ringash, Jolie; Brierley, James D.; Cummings, Bernard J.; Brade, Anthony [Princess Margaret Cancer Centre, University Health Network, Department of Radiation Oncology, University of Toronto, Toronto (Canada); Dawson, Laura A., E-mail: laura.dawson@rmp.uhn.on.ca [Princess Margaret Cancer Centre, University Health Network, Department of Radiation Oncology, University of Toronto, Toronto (Canada)

2013-12-01

Purpose: Reduction of respiratory motion is desirable to reduce the volume of normal tissues irradiated, to improve concordance of planned and delivered doses, and to improve image guided radiation therapy (IGRT). We hypothesized that pretreatment lorazepam would lead to a measurable reduction of liver motion. Methods and Materials: Thirty-three patients receiving upper abdominal IGRT were recruited to a double-blinded randomized controlled crossover trial. Patients were randomized to 1 of 2 study arms: arm 1 received lorazepam 2 mg by mouth on day 1, followed by placebo 4 to 8 days later; arm 2 received placebo on day 1, followed by lorazepam 4 to 8 days later. After tablet ingestion and daily radiation therapy, amplitude of liver motion was measured on both study days. The primary outcomes were reduction in craniocaudal (CC) liver motion using 4-dimensional kV cone beam computed tomography (CBCT) and the proportion of patients with liver motion ≤5 mm. Secondary endpoints included motion measured with cine magnetic resonance imaging and kV fluoroscopy. Results: Mean relative and absolute reduction in CC amplitude with lorazepam was 21% and 2.5 mm respectively (95% confidence interval [CI] 1.1-3.9, P=.001), as assessed with CBCT. Reduction in CC amplitude to ≤5 mm residual liver motion was seen in 13% (95% CI 1%-25%) of patients receiving lorazepam (vs 10% receiving placebo, P=NS); 65% (95% CI 48%-81%) had reduction in residual CC liver motion to ≤10 mm (vs 52% with placebo, P=NS). Patients with large respiratory movement and patients who took lorazepam ≥60 minutes before imaging had greater reductions in liver CC motion. Mean reductions in liver CC amplitude on magnetic resonance imaging and fluoroscopy were nonsignificant. Conclusions: Lorazepam reduces liver motion in the CC direction; however, average magnitude of reduction is small, and most patients have residual motion >5 mm.

High Mortality without ESCAPE: The Registry of Heart Failure Patients Receiving Pulmonary Artery Catheters without Randomization

Science.gov (United States)

Allen, Larry A.; Rogers, Joseph G.; Warnica, J. Wayne; DiSalvo, Thomas G.; Tasissa, Gudaye; Binanay, Cynthia; O’Connor, Christopher M.; Califf, Robert M.; Leier, Carl V.; Shah, Monica R.; Stevenson, Lynne W.

2008-01-01

Background In ESCAPE, there was no difference in days alive and out of the hospital for patients with decompensated heart failure (HF) randomly assigned to therapy guided by pulmonary artery catheter (PAC) plus clinical assessment versus clinical assessment alone. The external validity of these findings is debated. Methods and Results ESCAPE sites enrolled 439 patients receiving PAC without randomization in a prospective registry. Baseline characteristics, pertinent trial exclusion criteria, reasons for PAC use, hemodynamics, and complications were collected. Survival was determined from the National Death Index and the Alberta Registry. On average, registry patients had lower blood pressure, worse renal function, less neurohormonal antagonist therapy, and higher use of intravenous inotropes as compared with trial patients. Although clinical assessment anticipated less volume overload and greater hypoperfusion among the registry population, measured filling pressures were similarly elevated in the registry and trial, while measured perfusion was slightly higher among registry patients. Registry patients had longer hospitalization (13 vs. 6 days, p <0.001) and higher 6-month mortality (34% vs. 20%, p < 0.001) than trial patients. Conclusions The decision to use PAC without randomization identified a population with higher disease severity and risk of mortality. This prospective registry highlights the complex context of patient selection for randomized trials. PMID:18926438

Size-dependent piezoelectric energy-harvesting analysis of micro/nano bridges subjected to random ambient excitations

Science.gov (United States)

Radgolchin, Moeen; Moeenfard, Hamid

2018-02-01

The construction of self-powered micro-electro-mechanical units by converting the mechanical energy of the systems into electrical power has attracted much attention in recent years. While power harvesting from deterministic external excitations is state of the art, it has been much more difficult to derive mathematical models for scavenging electrical energy from ambient random vibrations, due to the stochastic nature of the excitations. The current research concerns analytical modeling of micro-bridge energy harvesters based on random vibration theory. Since classical elasticity fails to accurately predict the mechanical behavior of micro-structures, strain gradient theory is employed as a powerful tool to increase the accuracy of the random vibration modeling of the micro-harvester. Equations of motion of the system in the time domain are derived using the Lagrange approach. These are then utilized to determine the frequency and impulse responses of the structure. Assuming the energy harvester to be subjected to a combination of broadband and limited-band random support motion and transverse loading, closed-form expressions for mean, mean square, correlation and spectral density of the output power are derived. The suggested formulation is further exploited to investigate the effect of the different design parameters, including the geometric properties of the structure as well as the properties of the electrical circuit on the resulting power. Furthermore, the effect of length scale parameters on the harvested energy is investigated in detail. It is observed that the predictions of classical and even simple size-dependent theories (such as couple stress) appreciably differ from the findings of strain gradient theory on the basis of random vibration. This study presents a first-time modeling of micro-scale harvesters under stochastic excitations using a size-dependent approach and can be considered as a reliable foundation for future research in the field of

Sequential mediating effects of provided and received social support on trait emotional intelligence and subjective happiness: A longitudinal examination in Hong Kong Chinese university students.

Science.gov (United States)

Ye, Jiawen; Yeung, Dannii Y; Liu, Elaine S C; Rochelle, Tina L

2018-04-03

Past research has often focused on the effects of emotional intelligence and received social support on subjective well-being yet paid limited attention to the effects of provided social support. This study adopted a longitudinal design to examine the sequential mediating effects of provided and received social support on the relationship between trait emotional intelligence and subjective happiness. A total of 214 Hong Kong Chinese undergraduates were asked to complete two assessments with a 6-month interval in between. The results of the sequential mediation analysis indicated that the trait emotional intelligence measured in Time 1 indirectly influenced the level of subjective happiness in Time 2 through a sequential pathway of social support provided for others in Time 1 and social support received from others in Time 2. These findings highlight the importance of trait emotional intelligence and the reciprocal exchanges of social support in the subjective well-being of university students. © 2018 International Union of Psychological Science.

Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects.

Science.gov (United States)

James, W Philip T; Caterson, Ian D; Coutinho, Walmir; Finer, Nick; Van Gaal, Luc F; Maggioni, Aldo P; Torp-Pedersen, Christian; Sharma, Arya M; Shepherd, Gillian M; Rode, Richard A; Renz, Cheryl L

2010-09-02

The long-term effects of sibutramine treatment on the rates of cardiovascular events and cardiovascular death among subjects at high cardiovascular risk have not been established. We enrolled in our study 10,744 overweight or obese subjects, 55 years of age or older, with preexisting cardiovascular disease, type 2 diabetes mellitus, or both to assess the cardiovascular consequences of weight management with and without sibutramine in subjects at high risk for cardiovascular events. All the subjects received sibutramine in addition to participating in a weight-management program during a 6-week, single-blind, lead-in period, after which 9804 subjects underwent random assignment in a double-blind fashion to sibutramine (4906 subjects) or placebo (4898 subjects). The primary end point was the time from randomization to the first occurrence of a primary outcome event (nonfatal myocardial infarction, nonfatal stroke, resuscitation after cardiac arrest, or cardiovascular death). The mean duration of treatment was 3.4 years. The mean weight loss during the lead-in period was 2.6 kg; after randomization, the subjects in the sibutramine group achieved and maintained further weight reduction (mean, 1.7 kg). The mean blood pressure decreased in both groups, with greater reductions in the placebo group than in the sibutramine group (mean difference, 1.2/1.4 mm Hg). The risk of a primary outcome event was 11.4% in the sibutramine group as compared with 10.0% in the placebo group (hazard ratio, 1.16; 95% confidence interval [CI], 1.03 to 1.31; P=0.02). The rates of nonfatal myocardial infarction and nonfatal stroke were 4.1% and 2.6% in the sibutramine group and 3.2% and 1.9% in the placebo group, respectively (hazard ratio for nonfatal myocardial infarction, 1.28; 95% CI, 1.04 to 1.57; P=0.02; hazard ratio for nonfatal stroke, 1.36; 95% CI, 1.04 to 1.77; P=0.03). The rates of cardiovascular death and death from any cause were not increased. Subjects with preexisting

Arm rehabilitation in post stroke subjects: A randomized controlled trial on the efficacy of myoelectrically driven FES applied in a task-oriented approach.

Science.gov (United States)

Jonsdottir, Johanna; Thorsen, Rune; Aprile, Irene; Galeri, Silvia; Spannocchi, Giovanna; Beghi, Ettore; Bianchi, Elisa; Montesano, Angelo; Ferrarin, Maurizio

2017-01-01

Motor recovery of persons after stroke may be enhanced by a novel approach where residual muscle activity is facilitated by patient-controlled electrical muscle activation. Myoelectric activity from hemiparetic muscles is then used for continuous control of functional electrical stimulation (MeCFES) of same or synergic muscles to promote restoration of movements during task-oriented therapy (TOT). Use of MeCFES during TOT may help to obtain a larger functional and neurological recovery than otherwise possible. Multicenter randomized controlled trial. Eighty two acute and chronic stroke victims were recruited through the collaborating facilities and after signing an informed consent were randomized to receive either the experimental (MeCFES assisted TOT (M-TOT) or conventional rehabilitation care including TOT (C-TOT). Both groups received 45 minutes of rehabilitation over 25 sessions. Outcomes were Action Research Arm Test (ARAT), Upper Extremity Fugl-Meyer Assessment (FMA-UE) scores and Disability of the Arm Shoulder and Hand questionnaire. Sixty eight subjects completed the protocol (Mean age 66.2, range 36.5-88.7, onset months 12.7, range 0.8-19.1) of which 45 were seen at follow up 5 weeks later. There were significant improvements in both groups on ARAT (median improvement: MeCFES TOT group 3.0; C-TOT group 2.0) and FMA-UE (median improvement: M-TOT 4.5; C-TOT 3.5). Considering subacute subjects (time since stroke rehabilitation (57.9%) than in the C-TOT group (33.2%) (difference in proportion improved 24.7%; 95% CI -4.0; 48.6), though the study did not meet the planned sample size. This is the first large multicentre RCT to compare MeCFES assisted TOT with conventional care TOT for the upper extremity. No adverse events or negative outcomes were encountered, thus we conclude that MeCFES can be a safe adjunct to rehabilitation that could promote recovery of upper limb function in persons after stroke, particularly when applied in the subacute phase.

Physiotherapy programme reduces fatigue in patients with advanced cancer receiving palliative care: randomized controlled trial.

Science.gov (United States)

Pyszora, Anna; Budzyński, Jacek; Wójcik, Agnieszka; Prokop, Anna; Krajnik, Małgorzata

2017-09-01

Cancer-related fatigue (CRF) is a common and relevant symptom in patients with advanced cancer that significantly decreases their quality of life. The aim of this study was to evaluate the effect of a physiotherapy programme on CRF and other symptoms in patients diagnosed with advanced cancer. The study was designed as a randomized controlled trial. Sixty patients diagnosed with advanced cancer receiving palliative care were randomized into two groups: the treatment group (n = 30) and the control group (n = 30). The therapy took place three times a week for 2 weeks. The 30-min physiotherapy session included active exercises, myofascial release and proprioceptive neuromuscular facilitation (PNF) techniques. The control group did not exercise. The outcomes included Brief Fatigue Inventory (BFI), Edmonton Symptom Assessment Scale (ESAS) and satisfaction scores. The exercise programme caused a significant reduction in fatigue scores (BFI) in terms of severity of fatigue and its impact on daily functioning. In the control group, no significant changes in the BFI were observed. Moreover, the physiotherapy programme improved patients' general well-being and reduced the intensity of coexisting symptoms such as pain, drowsiness, lack of appetite and depression. The analysis of satisfaction scores showed that it was also positively evaluated by patients. The physiotherapy programme, which included active exercises, myofascial release and PNF techniques, had beneficial effects on CRF and other symptoms in patients with advanced cancer who received palliative care. The results of the study suggest that physiotherapy is a safe and effective method of CRF management.

Selection bias and subject refusal in a cluster-randomized controlled trial

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Rochelle Yang

2017-07-01

Full Text Available Abstract Background Selection bias and non-participation bias are major methodological concerns which impact external validity. Cluster-randomized controlled trials are especially prone to selection bias as it is impractical to blind clusters to their allocation into intervention or control. This study assessed the impact of selection bias in a large cluster-randomized controlled trial. Methods The Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care (ICARE study examined the impact of a remote pharmacist-led intervention in twelve medical offices. To assess eligibility, a standardized form containing patient demographics and medical information was completed for each screened patient. Eligible patients were approached by the study coordinator for recruitment. Both the study coordinator and the patient were aware of the site’s allocation prior to consent. Patients who consented or declined to participate were compared across control and intervention arms for differing characteristics. Statistical significance was determined using a two-tailed, equal variance t-test and a chi-square test with adjusted Bonferroni p-values. Results were adjusted for random cluster variation. Results There were 2749 completed screening forms returned to research staff with 461 subjects who had either consented or declined participation. Patients with poorly controlled diabetes were found to be significantly more likely to decline participation in intervention sites compared to those in control sites. A higher mean diastolic blood pressure was seen in patients with uncontrolled hypertension who declined in the control sites compared to those who declined in the intervention sites. However, these findings were no longer significant after adjustment for random variation among the sites. After this adjustment, females were now found to be significantly more likely to consent than males (odds ratio = 1.41; 95% confidence interval = 1.03, 1

Potassium and magnesium distribution, ECG changes, and ventricular ectopic beats during beta 2-adrenergic stimulation with terbutaline in healthy subjects

DEFF Research Database (Denmark)

Tveskov, C; Djurhuus, M S; Klitgaard, N A

1994-01-01

OBJECTIVE: To study the effect of intravenous (i.v.) terbutaline on potassium (K) and magnesium (Mg) distribution, ECG changes, and prevalence of ventricular ectopic beats in healthy subjects. DESIGN: Randomized double-blind, placebo-controlled crossover. Subjects received either placebo or terbu......OBJECTIVE: To study the effect of intravenous (i.v.) terbutaline on potassium (K) and magnesium (Mg) distribution, ECG changes, and prevalence of ventricular ectopic beats in healthy subjects. DESIGN: Randomized double-blind, placebo-controlled crossover. Subjects received either placebo......-potassium pump number. Urinary excretion of potassium and magnesium. ECG changes (T-wave and QTC interval) and the number of ventricular ectopic beats. MAIN RESULTS: Terbutaline produced an immediate decrease in serum potassium level from 4.17 (4.04 to 4.30) mmol/L to a nadir of 3.32 (3.06 to 3.58) mmol/L (p ... of sodium-potassium pumps. Furthermore, terbutaline induced changes in ECG with a highly significant lengthening of the QTc interval but with an unchanged number of ventricular ectopic beats in healthy subjects....

Random excitation forces in tube bundles subjected to two-phase cross-flow

International Nuclear Information System (INIS)

Taylor, C.E.; Pettigrew, M.J.; Currie, I.G.

1996-01-01

Data from two experimental programs have been analyzed to determine the characteristics of the random excitation forces associated with two-phase cross-flow in tube bundles. Large-scale air-water flow loops in France and Canada were used to generate the data. Tests were carried out on cantilevered, clamped-pinned, and clamped-clamped tubes in normal-square, parallel-triangular, and normal-triangular configurations. Either strain gages or force transducers were used to measure the vibration response of a centrally located tube as the tue array was subjected to a wide range of void fractions and flow rates. Power spectra were analyzed to determine the effect of parameters such as tube diameter, frequency, flow rate, void fraction, and flow regime on the random excitation forces. Normalized expressions for the excitation force power spectra were found to be flow-regime dependent. In the churn flow regime, flow rate and void fraction had very little effect on the magnitude of the excitation forces. In the bubble-plug flow regime, the excitation forces increased rapidly with flow rate and void fraction

Effects of Whole Grain Wheat Bread on Visceral Fat Obesity in Japanese Subjects: A Randomized Double-Blind Study.

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Kikuchi, Yosuke; Nozaki, Satomi; Makita, Miki; Yokozuka, Shoji; Fukudome, Shin-Ichi; Yanagisawa, Takashi; Aoe, Seiichiro

2018-04-18

Metabolic syndrome is a risk factor for cardiovascular diseases and has become increasingly common in Japan. Epidemiological studies show inverse associations between intake of whole wheat grains and metabolic syndrome, but few dietary intervention trials have investigated the effect of whole wheat grain consumption. It was investigated whether a diet in which refined wheat bread (RW diet) was substituted by whole grain wheat bread (WW diet) would reduce visceral fat obesity in Japanese subjects. A randomized double-blind placebo-controlled intervention study was conducted in 50 Japanese subjects with body mass index (BMI) ≥ 23 kg/m 2 . Subjects were randomly assigned WW (WW group) or RW diets (RW group) for 12 weeks. Blood samples and computed tomography scans were obtained every 6th week. The WW group showed decrease (-4 cm 2 ) in visceral fat area (VFA) (p < 0.05), whereas the RW group showed no significant changes. These time-dependent changes were significantly different between the groups. WW diet led to significant and safe reductions in VFA in subjects with BMI ≥ 23 kg/m 2 . WW diet may contribute to preventing visceral fat obesity.

A general symplectic method for the response analysis of infinitely periodic structures subjected to random excitations

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You-Wei Zhang

Full Text Available A general symplectic method for the random response analysis of infinitely periodic structures subjected to stationary/non-stationary random excitations is developed using symplectic mathematics in conjunction with variable separation and the pseudo-excitation method (PEM. Starting from the equation of motion for a single loaded substructure, symplectic analysis is firstly used to eliminate the dependent degrees of the freedom through condensation. A Fourier expansion of the condensed equation of motion is then applied to separate the variables of time and wave number, thus enabling the necessary recurrence scheme to be developed. The random response is finally determined by implementing PEM. The proposed method is justified by comparison with results available in the literature and is then applied to a more complicated time-dependent coupled system.

Effects of Ganglioside on Working Memory and the Default Mode Network in Individuals with Subjective Cognitive Impairment: A Randomized Controlled Trial.

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Jeon, Yujin; Kim, Binna; Kim, Jieun E; Kim, Bori R; Ban, Soonhyun; Jeong, Jee Hyang; Kwon, Oran; Rhie, Sandy Jeong; Ahn, Chang-Won; Kim, Jong-Hoon; Jung, Sung Ug; Park, Soo-Hyun; Lyoo, In Kyoon; Yoon, Sujung

2016-01-01

This randomized, double-blind, placebo-controlled trial examined whether the administration of ganglioside, an active ingredient of deer bone extract, can improve working memory performance by increasing gray matter volume and functional connectivity in the default mode network (DMN) in individuals with subjective cognitive impairment. Seventy-five individuals with subjective cognitive impairment were chosen to receive either ganglioside (330[Formula: see text][Formula: see text]g/day or 660[Formula: see text][Formula: see text]g/day) or a placebo for 8 weeks. Changes in working memory performance with treatment of either ganglioside or placebo were assessed as cognitive outcome measures. Using voxel-based morphometry and functional connectivity analyses, changes in gray matter volume and functional connectivity in the DMN were also assessed as brain outcome measures. Improvement in working memory performance was greater in the ganglioside group than in the placebo group. The ganglioside group, relative to the placebo group, showed greater increases in gray matter volume and functional connectivity in the DMN. A significant relationship between increased functional connectivity of the precuneus and improved working memory performance was observed in the ganglioside group. The current findings suggest that ganglioside has cognitive-enhancing effects in individuals with subjective cognitive impairment. Ganglioside-induced increases in gray matter volume and functional connectivity in the DMN may partly be responsible for the potential nootropic effects of ganglioside. The clinical trial was registered with ClinicalTrials.gov (identifier: NCT02379481).

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

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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

The estimation of branching curves in the presence of subject-specific random effects.

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Elmi, Angelo; Ratcliffe, Sarah J; Guo, Wensheng

2014-12-20

Branching curves are a technique for modeling curves that change trajectory at a change (branching) point. Currently, the estimation framework is limited to independent data, and smoothing splines are used for estimation. This article aims to extend the branching curve framework to the longitudinal data setting where the branching point varies by subject. If the branching point is modeled as a random effect, then the longitudinal branching curve framework is a semiparametric nonlinear mixed effects model. Given existing issues with using random effects within a smoothing spline, we express the model as a B-spline based semiparametric nonlinear mixed effects model. Simple, clever smoothness constraints are enforced on the B-splines at the change point. The method is applied to Women's Health data where we model the shape of the labor curve (cervical dilation measured longitudinally) before and after treatment with oxytocin (a labor stimulant). Copyright © 2014 John Wiley & Sons, Ltd.

An open-label, randomized, controlled, multicenter study exploring two treatment strategies of rivaroxaban and a dose-adjusted oral vitamin K antagonist treatment strategy in subjects with atrial fibrillation who undergo percutaneous coronary intervention (PIONEER AF-PCI).

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Gibson, C Michael; Mehran, Roxana; Bode, Christoph; Halperin, Johnathan; Verheugt, Freek; Wildgoose, Peter; van Eickels, Martin; Lip, Gregory Y H; Cohen, Marc; Husted, Steen; Peterson, Eric; Fox, Keith

2015-04-01

Guidelines recommendations regarding anticoagulant therapy after percutaneous coronary intervention (PCI) among patients with atrial fibrillation (AF) rely on retrospective, nonrandomized observational data. Currently, patients are treated with triple-therapy (dual antiplatelet therapy [DAPT] + oral anticoagulation therapy), but neither the duration of DAPT nor the level of anticoagulation has been studied in a randomized fashion. Recent studies also suggest dual pathway therapy with clopidogrel plus oral anticoagulation therapy may be superior, and other studies suggest that novel oral anticoagulants such as rivaroxaban may further improve patient outcomes. PIONEER AF-PCI (ClinicalTrials.gov NCT01830543) is an exploratory, open-label, randomized, multicenter clinical study assessing the safety of 2 rivaroxaban treatment strategies and 1 vitamin K antagonist (VKA) treatment strategy in subjects who have paroxysmal, persistent, or permanent nonvalvular AF and have undergone PCI with stent placement. Approximately 2,100 subjects will be randomized in a 1:1:1 ratio to receive either rivaroxaban 15 mg once daily plus clopidogrel 75 mg daily for 12 months (a WOEST trial-like strategy), or rivaroxaban 2.5 mg twice daily (with stratification to a prespecified duration of DAPT 1, 6, or 12 months, an ATLAS trial-like strategy), or dose-adjusted VKA once daily (with stratification to a prespecified duration of DAPT 1, 6, or 12 months, traditional triple therapy). All patients will be followed up for 12 months for the primary composite end point of Thrombolysis in Myocardial Infarction major bleeding, bleeding requiring medical attention, and minor bleeding (collectively, clinically significant bleeding). The PIONEER AF-PCI study is the first randomized comparison of VKA vs novel oral anticoagulant therapy in patients with NVAF receiving antiplatelet therapy after PCI to assess the relative risks of bleeding complications. Copyright © 2014 Elsevier Inc. All rights reserved.

First-In-Human, Double-Blind, Placebo-Controlled, Randomized, Dose-Escalation Study of BG00010, a Glial Cell Line-Derived Neurotrophic Factor Family Member, in Subjects with Unilateral Sciatica.

Science.gov (United States)

Rolan, Paul E; O'Neill, Gilmore; Versage, Eve; Rana, Jitesh; Tang, Yongqiang; Galluppi, Gerald; Aycardi, Ernesto

2015-01-01

To evaluate the safety, tolerability, and pharmacokinetics of single doses of BG00010 (neublastin, artemin, enovin) in subjects with unilateral sciatica. This was a single-center, blinded, placebo-controlled, randomized Phase 1 sequential-cohort, dose-escalation study (ClinicalTrials.gov identifier NCT00961766; funded by Biogen Idec). Adults with unilateral sciatica were enrolled at The Royal Adelaide Hospital, Australia. Four subjects were assigned to each of eleven cohorts (intravenous BG00010 0.3, 1, 3, 10, 25, 50, 100, 200, 400, or 800 μg/kg, or subcutaneous BG00010 50 μg/kg) and were randomized 3:1 to receive a single dose of BG00010 or placebo. The primary safety and tolerability assessments were: adverse events; clinical laboratory parameters and vital signs; pain as measured by a Likert rating scale; intra-epidermal nerve fiber density; and longitudinal assessment of quantitative sensory test parameters. Blood, serum, and plasma samples were collected for pharmacokinetic and pharmacodynamic assessments. Subjects were blinded to treatment assignment throughout the study. The investigator was blinded to treatment assignment until the Data Safety Review Committee review of unblinded data, which occurred after day 28. Beyond the planned enrollment of 44 subjects, four additional subjects were enrolled into to the intravenous BG00010 200 μg/kg cohort after one original subject experienced mild generalized pruritus. Therefore, a total of 48 subjects were enrolled between August 2009 and December 2011; all were included in the safety analyses. BG00010 was generally well tolerated: in primary analyses, the most common treatment-emergent adverse events were changes in temperature perception, pruritus, rash, or headache; no trends were observed in clinical laboratory parameters, vital signs, intra-epidermal nerve fiber density, or quantitative sensory testing. BG00010 was not associated with any clear, dose-dependent trends in Likert pain scores. BG00010 was

Zinc monotherapy increases serum brain-derived neurotrophic factor (BDNF) levels and decreases depressive symptoms in overweight or obese subjects: a double-blind, randomized, placebo-controlled trial.

Science.gov (United States)

Solati, Zahra; Jazayeri, Shima; Tehrani-Doost, Mehdi; Mahmoodianfard, Salma; Gohari, Mahmood Reza

2015-05-01

Previous studies have shown a positive effect of zinc as an adjunctive therapy on reducing depressive symptoms. However, to our knowledge, no study has examined the effect of zinc monotherapy on mood. The aim of the present study was to determine the effects of zinc monotherapy on depressive symptoms and serum brain-derived neurotrophic factor (BDNF) levels in overweight or obese subjects. Fifty overweight or obese subjects were randomly assigned into two groups and received either 30 mg zinc or placebo daily for 12 weeks. At baseline and post-intervention, depression severity was assessed using Beck depression inventory II (BDI II), and serum BDNF and zinc levels were determined by enzyme-linked immunosorbent assay and atomic absorption spectrophotometry, respectively. The trial was completed with 46 subjects. After a 12-week supplementation, serum zinc and BDNF levels increased significantly in the zinc-supplemented group compared with the placebo group. BDI scores declined in both the groups at the end of the study, but reduction in the zinc-supplemented group was significantly higher than the placebo group. More analysis revealed that following supplementation, BDI scores decreased in subgroup of subjects with depressive symptoms (BDI ≥ 10) (n = 30), but did not change in the subgroup of non-depressed subjects (BDI BDNF levels and depression severity in all participants. Interestingly, a significant positive correlation was found between serum BDNF and zinc levels at baseline. Zinc monotherapy improves mood in overweight or obese subjects most likely through increasing BDNF levels.

A controlled, randomized, delayed-start study of rasagiline in early Parkinson disease.

Science.gov (United States)

2004-04-01

Treatment with rasagiline mesylate, an irreversible monoamine oxidase type B inhibitor, improves symptoms of early Parkinson disease (PD). Preclinical studies suggest that this compound may also modify the progression of PD. To compare the effects of early and later initiation of rasagiline on progression of disability in patients with PD. Double-blind, parallel-group, randomized, delayed-start clinical trial. Four hundred four subjects with early PD, not requiring dopaminergic therapy, enrolled at 32 sites in the United States and Canada. Subjects were randomized to receive rasagiline, 1 or 2 mg/d, for 1 year or placebo for 6 months followed by rasagiline, 2 mg/d, for 6 months. Change in total Unified Parkinson's Disease Rating Scale score from baseline to 12 months. Three hundred seventy-one subjects were included in the 1-year efficacy analysis. Subjects treated with rasagiline, 2 mg/d, for 1 year had a 2.29-unit smaller increase in mean adjusted total Unified Parkinson's Disease Rating Scale score compared with subjects treated with placebo for 6 months followed by rasagiline, 2 mg/d, for 6 months (P =.01). The mean adjusted difference between the placebo/rasagiline, 2 mg/d, group and those receiving rasagiline, 1 mg/d, for 1 year was -1.82 unit on the Unified Parkinson's Disease Rating Scale score (P =.05). Subjects treated with rasagiline, 2 and 1 mg/d, for 12 months showed less functional decline than subjects whose treatment was delayed for 6 months.

Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial

Science.gov (United States)

2011-01-01

Background Periodontal disease (PD) is an infectious clinical entity characterized by the destruction of supporting tissues of the teeth as the result of a chronic inflammatory response in a susceptible host. It has been proposed that PD as subclinical infection may contribute to the etiology and to the pathogenesis of several systemic diseases including Atherosclerosis. A number of epidemiological studies link periodontal disease/edentulism as independent risk factor for acute myocardial infarction, peripheral vascular disease, and cerebrovascular disease. Moreover, new randomized controlled clinical trials have shown an improvement on cardiovascular surrogate markers (endothelial function, sICAM, hsPCR level, fibrinogen) after periodontal treatment. Nonetheless, such trials are still limited in terms of external validity, periodontal treatment strategies, CONSORT-based design and results consistency/extrapolation. The current study is designed to evaluate if periodontal treatment with scaling and root planning plus local delivered chlorhexidine improves endothelial function and other biomarkers of cardiovascular disease in subjects with moderate to severe periodontitis. Methods/Design This randomized, single-blind clinical trial will be performed at two health centers and will include two periodontal treatment strategies. After medical/periodontal screening, a baseline endothelium-dependent brachial artery flow-mediated dilatation (FMD) and other systemic surrogate markers will be obtained from all recruited subjects. Patients then will be randomized to receive either supragingival/subgingival plaque cleaning and calculus removal plus chlorhexidine (treatment group) or supragingival plaque removal only (control group). A second and third FMD will be obtained after 24 hours and 12 weeks in both treatment arms. Each group will consist of 49 patients (n = 98) and all patients will be followed-up for secondary outcomes and will be monitored through a coordinating

Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial

Directory of Open Access Journals (Sweden)

Arce Roger M

2011-02-01

Full Text Available Abstract Background Periodontal disease (PD is an infectious clinical entity characterized by the destruction of supporting tissues of the teeth as the result of a chronic inflammatory response in a susceptible host. It has been proposed that PD as subclinical infection may contribute to the etiology and to the pathogenesis of several systemic diseases including Atherosclerosis. A number of epidemiological studies link periodontal disease/edentulism as independent risk factor for acute myocardial infarction, peripheral vascular disease, and cerebrovascular disease. Moreover, new randomized controlled clinical trials have shown an improvement on cardiovascular surrogate markers (endothelial function, sICAM, hsPCR level, fibrinogen after periodontal treatment. Nonetheless, such trials are still limited in terms of external validity, periodontal treatment strategies, CONSORT-based design and results consistency/extrapolation. The current study is designed to evaluate if periodontal treatment with scaling and root planning plus local delivered chlorhexidine improves endothelial function and other biomarkers of cardiovascular disease in subjects with moderate to severe periodontitis. Methods/Design This randomized, single-blind clinical trial will be performed at two health centers and will include two periodontal treatment strategies. After medical/periodontal screening, a baseline endothelium-dependent brachial artery flow-mediated dilatation (FMD and other systemic surrogate markers will be obtained from all recruited subjects. Patients then will be randomized to receive either supragingival/subgingival plaque cleaning and calculus removal plus chlorhexidine (treatment group or supragingival plaque removal only (control group. A second and third FMD will be obtained after 24 hours and 12 weeks in both treatment arms. Each group will consist of 49 patients (n = 98 and all patients will be followed-up for secondary outcomes and will be monitored

Effect of Etelcalcetide vs Cinacalcet on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: A Randomized Clinical Trial.

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Block, Geoffrey A; Bushinsky, David A; Cheng, Sunfa; Cunningham, John; Dehmel, Bastian; Drueke, Tilman B; Ketteler, Markus; Kewalramani, Reshma; Martin, Kevin J; Moe, Sharon M; Patel, Uptal D; Silver, Justin; Sun, Yan; Wang, Hao; Chertow, Glenn M

2017-01-10

Secondary hyperparathyroidism contributes to extraskeletal calcification and is associated with all-cause and cardiovascular mortality. Control is suboptimal in the majority of patients receiving hemodialysis. An intravenously (IV) administered calcimimetic could improve adherence and reduce adverse gastrointestinal effects. To evaluate the relative efficacy and safety of the IV calcimimetic etelcalcetide and the oral calcimimetic cinacalcet. A randomized, double-blind, double-dummy active clinical trial was conducted comparing IV etelcalcetide vs oral placebo and oral cinacalcet vs IV placebo in 683 patients receiving hemodialysis with serum parathyroid hormone (PTH) concentrations higher than 500 pg/mL on active therapy at 164 sites in the United States, Canada, Europe, Russia, and New Zealand. Patients were enrolled from August 2013 to May 2014, with end of follow-up in January 2015. Etelcalcetide intravenously and oral placebo (n = 340) or oral cinacalcet and IV placebo (n = 343) for 26 weeks. The IV study drug was administered 3 times weekly with hemodialysis; the oral study drug was administered daily. The primary efficacy end point was noninferiority of etelcalcetide at achieving more than a 30% reduction from baseline in mean predialysis PTH concentrations during weeks 20-27 (noninferiority margin, 12.0%). Secondary end points included superiority in achieving biochemical end points (>50% and >30% reduction in PTH) and self-reported nausea or vomiting. The mean (SD) age of the trial participants was 54.7 (14.1) years and 56.2% were men. Etelcalcetide was noninferior to cinacalcet on the primary end point. The estimated difference in proportions of patients achieving reduction in PTH concentrations of more than 30% between the 198 of 343 patients (57.7%) randomized to receive cinacalcet and the 232 of 340 patients (68.2%) randomized to receive etelcalcetide was -10.5% (95% CI, -17.5% to -3.5%, P for noninferiority, secondary hyperparathyroidism, the

Effect of Hydroxychloroquine Treatment on Dry Eyes in Subjects with Primary Sjögren's Syndrome: a Double-Blind Randomized Control Study.

Science.gov (United States)

Yoon, Chang Ho; Lee, Hyun Ju; Lee, Eun Young; Lee, Eun Bong; Lee, Won-Woo; Kim, Mee Kum; Wee, Won Ryang

2016-07-01

The effect of hydroxychloroquine (HCQ) on dry eye has not been fully determined. This study aimed to compare the 12-week efficacy of HCQ medication with that of a placebo in the management of dry eye in primary Sjögren's syndrome (pSS). A double-blind, randomized control study was conducted in 39 pSS subjects from May 2011 through August 2013. pSS was diagnosed based on the classification criteria of the American-European Consensus Group. Subjects received 300 mg of HCQ or placebo once daily for 12 weeks and were evaluated at baseline, 6, and 12 weeks, with a re-visit at 16 weeks after drug discontinuance. The fluorescein staining score, Schirmer test score, tear film break-up time (TBUT), and ocular surface disease index (OSDI) were measured, and tears and blood were collected for ESR, IL-6, IL-17, B-cell activating factor (BAFF), and Th17 cell analysis. Color testing was performed and the fundus was examined to monitor HCQ complications. Twenty-six subjects completed the follow-up. The fluorescein staining score and Schirmer test score did not differ significantly. The OSDI improved with medication in the HCQ group but was not significantly different between the groups. TBUT, serum IL-6, ESR, serum and tear BAFF, and the proportion of Th17 cells did not change in either group. HCQ at 300 mg daily for 12 weeks has no apparent clinical benefit for dry eye and systemic inflammation in pSS (ClinicalTrials.gov. NCT01601028).

Analysis of 2-Week Data from Two Randomized, Controlled Trials Conducted in Subjects with Frequent Heartburn Treated with Esomeprazole 20 mg.

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Katz, Philip O; Le Moigne, Anne; Pollack, Charles

2017-05-01

These secondary analyses used data from 2 similarly designed studies in subjects experiencing frequent heartburn to evaluate the efficacy of esomeprazole 20 mg once daily for 2 weeks, which reflects the approved over-the-counter dosage and duration. Subjects without endoscopically identified erosive esophagitis who were experiencing heartburn for ≥6 months and ≥4 of 7 days prior to baseline (study 1, N = 368; study 2, N = 349) were randomly assigned to receive double-blind treatment with esomeprazole 40 or 20 mg (administered as esomeprazole magnesium trihydrate 44.5 and 22.3 mg, respectively) or placebo once daily for 4 weeks. Subjects recorded the severity of heartburn in a daily diary, and investigators assessed subjects at each study visit. Two-week assessments were the primary end points of interest in these analyses and included the percentage of subjects with complete heartburn resolution (no episodes during 7 consecutive days), time to sustained complete heartburn resolution (the first of 7 consecutive episode-free days), and heartburn relief (no episodes other than ≤1 mild episode during 7 consecutive days). At week 2, the percentages of subjects who experienced complete heartburn resolution were significantly greater with esomeprazole 40 mg (study 1, 26.1%; study 2, 35.3%) and 20 mg (study 1, 25.2%; study 2, 35.7%) compared with placebo (study 1, 9.0%; study 2, 3.4%) (all, P ≤ 0.001). Beginning on day 1, the percentages of subjects who experienced sustained heartburn resolution was significantly greater in the groups treated with esomeprazole 40 mg (study 1, 19%; study 2, 19%; P heartburn relief were significantly greater with esomeprazole 40 mg (study 1, 35.3%; study 2, 40.5%) and 20 mg (study 1, 34.5%; study 2, 46.4%) compared with placebo (study 1, 16.5%; study 2, 8.6%) (all, P ≤ 0.001). The results of this study demonstrate that once-daily treatment with esomeprazole 20 mg for 2 weeks effectively resolved subjects׳ heartburn compared with

The subjective experience of patients who received electroconvulsive therapy.

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Koopowitz, Leslie Frank; Chur-Hansen, Anna; Reid, Sally; Blashki, Miriam

2003-02-01

Despite the vast amount of scientific literature available on electroconvulsive therapy (ECT), there is little qualitative focus upon the patients' subjective experience of this procedure. Using an exploratory descriptive methodology, this study aims to provide a more unique insight into what certain patients actually think of ECT. Semistructured interviews were conducted to explore eight patients' opinions and experiences of ECT. Interviews were subjected to analysis by a five-step framework approach that identified prominent themes in relation to five broad questions and in conjunction with issues raised by the subjects themselves. Eleven major themes were identified. Four of these were chosen for discussion, not only as the most prevalent themes (in terms of how frequently they were mentioned by the subjects), but also as the most striking (in regards to the intensity of emotions evoked, or their influence on their perception of ECT as a future treatment option). The four themes are fear of ECT, attribution of cognitive decline and memory loss to ECT, positive ECT experiences, and patients' suggestions. Using such a qualitative approach, the depth of the information obtained has revealed new perspectives on how patients perceive the experience of ECT. Fears reported by patients present an opportunity to address specific areas of the procedure that generate the most angst. These were closely associated with recommendations that many patients proposed throughout the interviews. Patients' perceptions of the cognitive effects of ECT do not necessarily correspond with those commonly reported in the literature on ECT. Positive experiences with ECT were more complex than simply its efficacy. There is a need for future research in order to explore and address patients' experiences of ECT.

Effect of Supportive Nursing Care on Self Esteem of Patients Receiving Electroconvulsive Therapy: A Randomized Controlled Clinical Trial

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Ebrahimi, Hossein; Navidian, Ali; Keykha, Roghaieh

2014-01-01

Introduction: Self-esteem is an important potential indicator in etiology, diagnosis and treatment of patients with severe mental illness. ECT is a popular treatment for these patients that can effect on their self-esteem and reinforce their problems. The purpose of this study is to determine the effect of supportive nursing care in increasing self esteem of patients receiving ECT. Methods: This clinical trial was conducted in the Baharan psychiatric hospital of Zahedan. A total of 70 cases of patients who received ECT were randomly allocated to control (n=35) and intervention (n=35) groups. The data were collected by demographic characteristics questionnaire and Rosenberg Self Esteem Scale (RSES). Intervention group received the supportive nursing care. The control group received only routine treatment. Self esteem level was measured and compared before and after intervention for two groups. The data was analyzed by SPSS using the χ2, t-test and ANCOVA. Results: Results showed that both groups were homogeneous on the socio- demographic characteristics. The mean self esteem in the intervention group compared with the control group was significantly increased. While controlling the effects of individual and social variables, the result shows significant differences between two groups in the mean scores of self esteem after the intervention. Conclusion: The results suggest that supportive nursing care can have positive effect on self esteem of patients receiving ECT. It is recommended to use this method for increasing self esteem of these patients. PMID:25276758

Effect of supportive nursing care on self esteem of patients receiving electroconvulsive therapy: a randomized controlled clinical trial.

Science.gov (United States)

Ebrahimi, Hossein; Navidian, Ali; Keykha, Roghaieh

2014-06-01

Self-esteem is an important potential indicator in etiology, diagnosis and treatment of patients with severe mental illness. ECT is a popular treatment for these patients that can effect on their self-esteem and reinforce their problems. The purpose of this study is to determine the effect of supportive nursing care in increasing self esteem of patients receiving ECT. This clinical trial was conducted in the Baharan psychiatric hospital of Zahedan. A total of 70 cases of patients who received ECT were randomly allocated to control (n=35) and intervention (n=35) groups. The data were collected by demographic characteristics questionnaire and Rosenberg Self Esteem Scale (RSES). Intervention group received the supportive nursing care. The control group received only routine treatment. Self esteem level was measured and compared before and after intervention for two groups. The data was analyzed by SPSS using the χ(2), t-test and ANCOVA. RESULTS showed that both groups were homogeneous on the socio- demographic characteristics. The mean self esteem in the intervention group compared with the control group was significantly increased. While controlling the effects of individual and social variables, the result shows significant differences between two groups in the mean scores of self esteem after the intervention. The results suggest that supportive nursing care can have positive effect on self esteem of patients receiving ECT. It is recommended to use this method for increasing self esteem of these patients.

Effect of Supportive Nursing Care on Self Esteem of Patients Receiving Electroconvulsive Therapy: A Randomized Controlled Clinical Trial

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Hossein Ebrahimi

2014-06-01

Full Text Available Introduction: Self-esteem is an important potential indicator in etiology, diagnosis and treatment of patients with severe mental illness. ECT is a popular treatment for these patients that can effect on their self-esteem and reinforce their problems. The purpose of this study is to determine the effect of supportive nursing care in increasing self esteem of patients receiving ECT. Methods: This clinical trial was conducted in the Baharan psychiatric hospital of Zahedan. A total of 70 cases of patients who received ECT were randomly allocated to control (n=35 and intervention (n=35 groups. The data were collected by demographic characteristics questionnaire and Rosenberg Self Esteem Scale (RSES. Intervention group received the supportive nursing care. The control group received only routine treatment. Self esteem level was measured and compared before and after intervention for two groups. The data was analyzed by SPSS using the χ2, t-test and ANCOVA. Results: Results showed that both groups were homogeneous on the socio- demographic characteristics. The mean self esteem in the intervention group compared with the control group was significantly increased. While controlling the effects of individual and social variables, the result shows significant differences between two groups in the mean scores of self esteem after the intervention.Conclusion: The results suggest that supportive nursing care can have positive effect on self esteem of patients receiving ECT. It is recommended to use this method for increasing self esteem of these patients.

Low-FODMAP formula improves diarrhea and nutritional status in hospitalized patients receiving enteral nutrition: a randomized, multicenter, double-blind clinical trial.

Science.gov (United States)

Yoon, So Ra; Lee, Jong Hwa; Lee, Jae Hyang; Na, Ga Yoon; Lee, Kyun-Hee; Lee, Yoon-Bok; Jung, Gu-Hun; Kim, Oh Yoen

2015-11-03

Fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) are poorly absorbed, short-chain carbohydrates that play an important role in inducing functional gut symptoms. A low-FODMAP diet improves abdominal symptoms in patients with inflammatory bowel disease and irritable bowel syndrome. However, there were no study for the effect of FODMAP content on gastrointestinal intolerance and nutritional status in patients receiving enteral nutrition (EN). In this randomized, multicenter, double-blind, 14-day clinical trial, eligible hospitalized patients receiving EN (n = 100) were randomly assigned to three groups; 84 patients completed the trial (low-FODMAP EN, n = 30; moderate-FODMAP EN, n = 28; high-FODMAP EN, n = 26). Anthropometric and biochemical parameters were measured; stool assessment was performed using the King's Stool Chart and clinical definition. Baseline values were not significantly different among the three groups. After the 14-day intervention, diarrhea significantly improved in the low-FODMAP group than in the moderate- and high-FODMAP groups (P nutritional status and facilitating prompt recovery from illness.

Pharmacokinetic comparison of controlled-release and immediate-release oral formulations of simvastatin in healthy Korean subjects: a randomized, open-label, parallel-group, single- and multiple-dose study.

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Jang, Seong Bok; Lee, Yoon Jung; Lim, Lay Ahyoung; Park, Kyung-Mi; Kwon, Bong-Ju; Woo, Jong Soo; Kim, Yong-Il; Park, Min Soo; Kim, Kyung Hwan; Park, Kyungsoo

2010-01-01

A controlled-release (CR) formulation of simvastatin was recently developed in Korea. The formulation is expected to yield a lower C(max) and similar AUC values compared with the immediate-release (IR) formulation. The goal of this study was to compare the pharmacokinetics of the new CR formulation and an IR formulation of simvastatin after single- and multiple-dose administration in healthy Korean subjects. This study was developed as part of a product development project at the request of the Korean regulatory agency. This was a randomized, open-label, parallelgroup, 2-part study. Eligible subjects were healthy male or female volunteers between the ages of 19 and 55 years and within 20% of their ideal weight. In part I, each subject received a single dose of the CR or IR formulation of simvastatin 40 mg orally (20 mg x 2 tablets) after fasting. In part II, each subject received the same dose of the CR or IR formulation for 8 consecutive days. Blood samples were obtained for 48 hours after the dose in part I and after the first and the last dose in part II. Pharmacokinetic parameters were determined for both simvastatin (the inactive prodrug) and simvastatin acid (the active moiety). An adverse event (AE) was defined as any unfavorable sign (including an abnormal laboratory finding) or symptom, regardless of whether it had a causal relationship with the study medication. Serious AEs were defined as any events that are considered life threatening, require hospitalization or prolongation of existing hospitalization, cause persistent or significant disability or incapacity, or result in congenital abnormality, birth defect, or death. AEs were determined based on patient interviews and physical examinations. Twenty-four healthy subjects (17 men, 7 women; mean [SD] age, 29 [7] years; age range, 22-50 years) were enrolled in part I, and 29 subjects (17 men, 12 women; mean age, 33 [9] years; age range, 19-55 years) were enrolled in part II. For simvastatin acid, C

Randomized controlled trial using bosentan to enhance the impact of exercise training in subjects with type 2 diabetes mellitus.

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Schreuder, Tim H A; Duncker, Dirk J; Hopman, Maria T E; Thijssen, Dick H J

2014-11-01

In type 2 diabetes patients, endothelin (ET) receptor blockade may enhance blood flow responses to exercise training. The combination of exercise training and ET receptor blockade may represent a more potent stimulus than training alone to improve vascular function, physical fitness and glucose homeostasis. We assessed the effect of an 8 week exercise training programme combined with either ET blockade or placebo on vasculature, fitness and glucose homeostasis in people with type 2 diabetes. In a double-blind randomized controlled trial, brachial endothelium-dependent and ‑independent dilatation (using flow-mediated dilatation and glyceryl trinitrate, respectively), glucose homeostasis (using Homeostasis Model Assessment for Insulin Resistance (HOMA-IR)) and physical fitness (maximal cycling test) were assessed in 18 men with type 2 diabetes (60 ± 6 years old). Subjects underwent an 8 week exercise training programme, with half of the subjects receiving ET receptor blockade (bosentan) and the other half a placebo, followed by reassessment of the tests above. Exercise training improved physical fitness to a similar extent in both groups, but we did not detect changes in vascular function in either group. This study suggests that there is no adaptation in brachial and femoral artery endothelial function after 8 weeks of training in type 2 diabetes patients. Endothelin receptor blockade combined with exercise training does not additionally alter conduit artery endothelial function or physical fitness in type 2 diabetes. © 2014 The Authors. Experimental Physiology © 2014 The Physiological Society.

A Follow-Up Study from a Multisite, Randomized Controlled Trial for Traumatized Children Receiving TF-CBT.

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Jensen, Tine K; Holt, Tonje; Ormhaug, Silje M

2017-11-01

Trauma-focused cognitive behavioral therapy (TF-CBT) is the treatment of choice for traumatized youth, however, follow-up studies are scarce, and treatment effects for co-occurring depression show mixed findings. The aims of this study were to examine whether treatment effects of TF-CBT are maintained at 18 month follow-up and whether degree of co-occurring depression influences treatment effects. As rapid improvement in psychological functioning is warranted for youth, we also investigated whether the symptom trajectory was different for TF-CBT compared to therapy as usual (TAU). The sample consisted of 156 youth (M age = 15.05, 79.50% girls) randomly assigned to TF-CBT or TAU. The youth were assessed for posttraumatic stress symptoms (PTSS), depression, anxiety and general mental health symptoms. Mixed effects analyses followed the symptom courses over 5 time points. Youth receiving TF-CBT maintained their symptom improvement at 18 months follow-up with scores below clinical cut-of on all symptom measures. The most depressed youth had also a significant decline in symptoms that were maintained at follow-up. Symptom trajectories differed as the TF-CBT group reported a more rapid symptom reduction compared to the TAU condition. In the TAU condition, participants received 1.5 times the number of treatment sessions compared to the TF-CBT participants. After 18 months the groups were significantly different on general mental health symptoms only. In conclusion, youth receiving TF-CBT experienced more efficient improvement in trauma related symptoms than youth receiving TAU and these improvements were maintained after 18 months. Also youth experiencing serious co-occurring depression benefitted from TF-CBT.

Effect of Hydroxychloroquine Treatment on Dry Eyes in Subjects with Primary Sjögren’s Syndrome: a Double-Blind Randomized Control Study

Science.gov (United States)

2016-01-01

The effect of hydroxychloroquine (HCQ) on dry eye has not been fully determined. This study aimed to compare the 12-week efficacy of HCQ medication with that of a placebo in the management of dry eye in primary Sjögren's syndrome (pSS). A double-blind, randomized control study was conducted in 39 pSS subjects from May 2011 through August 2013. pSS was diagnosed based on the classification criteria of the American-European Consensus Group. Subjects received 300 mg of HCQ or placebo once daily for 12 weeks and were evaluated at baseline, 6, and 12 weeks, with a re-visit at 16 weeks after drug discontinuance. The fluorescein staining score, Schirmer test score, tear film break-up time (TBUT), and ocular surface disease index (OSDI) were measured, and tears and blood were collected for ESR, IL-6, IL-17, B-cell activating factor (BAFF), and Th17 cell analysis. Color testing was performed and the fundus was examined to monitor HCQ complications. Twenty-six subjects completed the follow-up. The fluorescein staining score and Schirmer test score did not differ significantly. The OSDI improved with medication in the HCQ group but was not significantly different between the groups. TBUT, serum IL-6, ESR, serum and tear BAFF, and the proportion of Th17 cells did not change in either group. HCQ at 300 mg daily for 12 weeks has no apparent clinical benefit for dry eye and systemic inflammation in pSS (ClinicalTrials.gov. NCT01601028). PMID:27366013

Clinical Evaluation of Acupuncture as Treatment for Complications of Cerebrovascular Accidents: A Randomized, Sham-Controlled, Subject- and Assessor-Blind Trial.

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Liao, Hsien-Yin; Ho, Wen-Chao; Chen, Chun-Chung; Lin, Jaung-Geng; Chang, Chia-Chi; Chen, Liang-Yu; Lee, De-Chih; Lee, Yu-Chen

2017-01-01

Background and Purpose . The effect of acupuncture as treatment for poststroke complications is questionable. We performed a randomized, sham-controlled double-blind study to investigate it. Methods . Patients with first-time acute stroke were randomized to receive 24 sessions of either real or sham acupuncture during an eight-week period. The primary outcome measure was change in National Institute of Health Stroke Scale (NIHSS) score. Secondary outcome measures included changes in Barthel Index (BI), Instrumental Activities of Daily Living (IADL), Hamilton Depression Rating Scale (HAM-D), and Visual Analogue Scale (VAS) for pain scores. Results . Of the 52 patients who were randomized to receive acupuncture ( n = 28) or placebo ( n = 24), 10 patients in the acupuncture group and 9 patients in the placebo group failed to complete the treatment. In total, 18 patients in the acupuncture group and 15 patients in the control group completed the treatment course. Reduction in pain was significantly greater in the acupuncture group than in the control group ( p value = 0.04). There were no significant differences in the other measures between the two groups. Conclusions . Acupuncture provided more effective poststroke pain relief than sham acupuncture treatment. However, acupuncture had no better effect on neurological, functional, and psychological improvement.

Clinical Evaluation of Acupuncture as Treatment for Complications of Cerebrovascular Accidents: A Randomized, Sham-Controlled, Subject- and Assessor-Blind Trial

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Hsien-Yin Liao

2017-01-01

Full Text Available Background and Purpose. The effect of acupuncture as treatment for poststroke complications is questionable. We performed a randomized, sham-controlled double-blind study to investigate it. Methods. Patients with first-time acute stroke were randomized to receive 24 sessions of either real or sham acupuncture during an eight-week period. The primary outcome measure was change in National Institute of Health Stroke Scale (NIHSS score. Secondary outcome measures included changes in Barthel Index (BI, Instrumental Activities of Daily Living (IADL, Hamilton Depression Rating Scale (HAM-D, and Visual Analogue Scale (VAS for pain scores. Results. Of the 52 patients who were randomized to receive acupuncture (n=28 or placebo (n=24, 10 patients in the acupuncture group and 9 patients in the placebo group failed to complete the treatment. In total, 18 patients in the acupuncture group and 15 patients in the control group completed the treatment course. Reduction in pain was significantly greater in the acupuncture group than in the control group (p value = 0.04. There were no significant differences in the other measures between the two groups. Conclusions. Acupuncture provided more effective poststroke pain relief than sham acupuncture treatment. However, acupuncture had no better effect on neurological, functional, and psychological improvement.

Changes of Insulin Resistance and Adipokines Following Supplementation with Glycyrrhiza Glabra L. Extract in Combination with a Low-Calorie Diet in Overweight and Obese Subjects: a Randomized Double Blind Clinical Trial

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Mohammad Alizadeh

2018-03-01

Full Text Available Purpose: Adipose tissue is a highly active endocrine organ which plays a key role in energy homeostasis. The aim of this study was to determine the effects of dried licorice extract along with a calorie restricted diet on body composition, insulin resistance and adipokines in overweight and obese subjects. Methods: Sixty-four overweight and obese volunteers (27 men, 37 women were recruited into this double-blind, placebo-controlled, randomized, clinical trial. Participants were randomly allocated to the Licorice (n=32 or the placebo group (n=32, and each group received a low-calorie diet with either 1.5 g/day of Licorice extract or placebo for 8 weeks. Biochemical parameters, anthropometric indices, body composition and dietary intake were measured at baseline and at the end of the study. Results: A total of 58 subjects completed the trial. No side effects were observed following licorice supplementation. At the end of the study, waist circumference, fat mass, serum levels of vaspin, zinc-α2 glycoprotein, insulin and HOMA-IR were significantly decreased in the intervention group, but only the reduction in serum vaspin levels in the licorice group was significant when compared to the placebo group (p<0.01. Conclusion: Supplementation with dried licorice extract plus a low-calorie diet can increase vaspin levels in obese subjects. However, the anti-obesity effects of the intervention were not stronger than a low-calorie diet alone in the management of obesity.

Characteristics of men with substance use disorder consequent to illicit drug use: comparison of a random sample and volunteers.

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Reynolds, Maureen D; Tarter, Ralph E; Kirisci, Levent

2004-09-06

Men qualifying for substance use disorder (SUD) consequent to consumption of an illicit drug were compared according to recruitment method. It was hypothesized that volunteers would be more self-disclosing and exhibit more severe disturbances compared to randomly recruited subjects. Personal, demographic, family, social, substance use, psychiatric, and SUD characteristics of volunteers (N = 146) were compared to randomly recruited (N = 102) subjects. Volunteers had lower socioceconomic status, were more likely to be African American, and had lower IQ than randomly recruited subjects. Volunteers also evidenced greater social and family maladjustment and more frequently had received treatment for substance abuse. In addition, lower social desirability response bias was observed in the volunteers. SUD was not more severe in the volunteers; however, they reported a higher lifetime rate of opiate, diet, depressant, and analgesic drug use. Volunteers and randomly recruited subjects qualifying for SUD consequent to illicit drug use are similar in SUD severity but differ in terms of severity of psychosocial disturbance and history of drug involvement. The factors discriminating volunteers and randomly recruited subjects are well known to impact on outcome, hence they need to be considered in research design, especially when selecting a sampling strategy in treatment research.

Aromatherapy Versus Oral Ondansetron for Antiemetic Therapy Among Adult Emergency Department Patients: A Randomized Controlled Trial.

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April, Michael D; Oliver, Joshua J; Davis, William T; Ong, David; Simon, Erica M; Ng, Patrick C; Hunter, Curtis J

2018-02-17

We compare aromatherapy with inhaled isopropyl alcohol versus oral ondansetron for treating nausea among emergency department (ED) patients not requiring immediate intravenous access. In a randomized, blinded, placebo-controlled trial, we enrolled a convenience sample of adults presenting to an urban tertiary care ED with chief complaints including nausea or vomiting. We randomized subjects to 1 of 3 arms: inhaled isopropyl alcohol and 4 mg oral ondansetron, inhaled isopropyl alcohol and oral placebo, and inhaled saline solution placebo and 4 mg oral ondansetron. The primary outcome was mean nausea reduction measured by a 0- to 100-mm visual analog scale from enrollment to 30 minutes postintervention. Secondary outcomes included receipt of rescue antiemetic medications and adverse events. We enrolled 122 subjects, of whom 120 (98.3%) completed the study. Of randomized subjects, 40 received inhaled isopropyl alcohol and oral ondansetron, 41 received inhaled isopropyl alcohol and oral placebo, and 41 received inhaled saline solution placebo and oral ondansetron. The mean decrease in nausea visual analog scale score in each arm was 30 mm (95% confidence interval [CI] 22 to 37 mm), 32 mm (95% CI 25 to 39 mm), and 9 mm (95% CI 5 to 14 mm), respectively. The proportions of subjects who received rescue antiemetic therapy in each arm were 27.5% (95% CI 14.6% to 43.9%), 25.0% (95% CI 12.7% to 41.2%), and 45.0% (95% CI 29.3% to 61.5%), respectively. There were no adverse events. Among ED patients with acute nausea and not requiring immediate intravenous access, aromatherapy with or without oral ondansetron provides greater nausea relief than oral ondansetron alone. Copyright © 2018 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

A comparison of low-dose risperidone to paroxetine in the treatment of panic attacks: a randomized, single-blind study

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Galynker Igor I

2009-05-01

Full Text Available Abstract Background Because a large proportion of patients with panic attacks receiving approved pharmacotherapy do not respond or respond poorly to medication, it is important to identify additional therapeutic strategies for the management of panic symptoms. This article describes a randomized, rater-blind study comparing low-dose risperidone to standard-of-care paroxetine for the treatment of panic attacks. Methods Fifty six subjects with a history of panic attacks were randomized to receive either risperidone or paroxetine. The subjects were then followed for eight weeks. Outcome measures included the Panic Disorder Severity Scale (PDSS, the Hamilton Anxiety Scale (Ham-A, the Hamilton Depression Rating Scale (Ham-D, the Sheehan Panic Anxiety Scale-Patient (SPAS-P, and the Clinical Global Impression scale (CGI. Results All subjects demonstrated a reduction in both the frequency and severity of panic attacks regardless of treatment received. Statistically significant improvements in rating scale scores for both groups were identified for the PDSS, the Ham-A, the Ham-D, and the CGI. There was no difference between treatment groups in the improvement in scores on the measures PDSS, Ham-A, Ham-D, and CGI. Post hoc tests suggest that subjects receiving risperidone may have a quicker clinical response than subjects receiving paroxetine. Conclusion We can identify no difference in the efficacy of paroxetine and low-dose risperidone in the treatment of panic attacks. Low-dose risperidone appears to be tolerated equally well as paroxetine. Low-dose risperidone may be an effective treatment for anxiety disorders in which panic attacks are a significant component. Trial Registration ClinicalTrials.gov Identifier: NCT100457106

Multi-regional local anesthetic infiltration during laparoscopic cholecystectomy in patients receiving prophylactic multi-modal analgesia: a randomized, double-blinded, placebo-controlled study

DEFF Research Database (Denmark)

Bisgaard, T; Klarskov, B; Kristiansen, V B

1999-01-01

undergoing elective laparoscopic cholecystectomy. In addition, all patients received multi-modal prophylactic analgesic treatment. Fifty-eight patients were randomized to receive a total of 286 mg (66 mL) ropivacaine or 66 mL saline via periportal and intraperitoneal infiltration. During the first 3...... postoperative h, the use of morphine and antiemetics was registered, and pain and nausea were rated hourly. Daily pain intensity, pain localization, and supplemental analgesic consumption were registered the first postoperative week. Ropivacaine reduced overall pain the first two hours and incisional pain...... for the first three postoperative hours (P ropivacaine group (P

A randomized, rater-blinded, crossover study of the effects of oxymorphone extended release, fed versus fasting, on cognitive performance as tested with CANTAB in opioid-tolerant subjects.

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Spierings, Egilius L H; Volkerts, Edmund R; Heitland, Ivo; Thomson, Heather

2014-02-01

The maximum plasma concentration (Cmax ) of oxymorphone extended release (ER) 20 mg and 40 mg is approximately 50% higher in fed than in fasted subjects, with most of the difference in area-under-the-curve (AUC) occurring in the first 4 hours post-dose. Hence, the US FDA recommends in the approved labeling that oxymorphone ER is taken at least 1 hour before or 2 hours after eating. In order to determine the potential impact on cognitive performance of the increased absorption of oxymorphone ER, fed versus fasting, we conducted a randomized, rater-blinded, crossover study in 30 opioid-tolerant subjects, using tests from the Cambridge Neuropsychological Test Automated Battery (CANTAB). The subjects randomly received 40 mg oxymorphone ER after a high-fat meal of approximately 1,010 kCal or after fasting for 8-12 hours, and were tested 1 hour and 3 hours post-dose. The CANTAB tests, Spatial Recognition Memory (SRM) and Spatial Working Memory (SWM), showed no statistically significant differences between the fed and fasting conditions. However, sustained attention, as measured by the Rapid Visual Information Processing (RVP) CANTAB test, showed a statistically significant interaction of fed versus fasting and post-dose time of testing (F[1,28] = 6.88, P = 0.01), suggesting that 40 mg oxymorphone ER after a high-fat meal versus fasting mitigates the learning effect in this particular cognition domain from 1 hour to 3 hours post-dose. Oxymorphone 40 mg ER affected cognitive performance similarly within 3 hours post-dose, whether given on an empty stomach or after a high-fat meal, suggesting that the effect of food on plasma concentration may not be relevant in the medication's impact on cognition. Wiley Periodicals, Inc.

Risk of Late Toxicity in Men Receiving Dose-Escalated Hypofractionated Intensity Modulated Prostate Radiation Therapy: Results From a Randomized Trial

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Hoffman, Karen E., E-mail: khoffman1@mdanderson.org; Voong, K. Ranh; Pugh, Thomas J.; Skinner, Heath; Levy, Lawrence B.; Takiar, Vinita; Choi, Seungtaek; Du, Weiliang; Frank, Steven J.; Johnson, Jennifer; Kanke, James; Kudchadker, Rajat J.; Lee, Andrew K.; Mahmood, Usama; McGuire, Sean E.; Kuban, Deborah A.

2014-04-01

Objective: To report late toxicity outcomes from a randomized trial comparing conventional and hypofractionated prostate radiation therapy and to identify dosimetric and clinical parameters associated with late toxicity after hypofractionated treatment. Methods and Materials: Men with localized prostate cancer were enrolled in a trial that randomized men to either conventionally fractionated intensity modulated radiation therapy (CIMRT, 75.6 Gy in 1.8-Gy fractions) or to dose-escalated hypofractionated IMRT (HIMRT, 72 Gy in 2.4-Gy fractions). Late (≥90 days after completion of radiation therapy) genitourinary (GU) and gastrointestinal (GI) toxicity were prospectively evaluated and scored according to modified Radiation Therapy Oncology Group criteria. Results: 101 men received CIMRT and 102 men received HIMRT. The median age was 68, and the median follow-up time was 6.0 years. Twenty-eight percent had low-risk, 71% had intermediate-risk, and 1% had high-risk disease. There was no difference in late GU toxicity in men treated with CIMRT and HIMRT. The actuarial 5-year grade ≥2 GU toxicity was 16.5% after CIMRT and 15.8% after HIMRT (P=.97). There was a nonsignificant numeric increase in late GI toxicity in men treated with HIMRT compared with men treated with CIMRT. The actuarial 5-year grade ≥2 GI toxicity was 5.1% after CIMRT and 10.0% after HIMRT (P=.11). In men receiving HIMRT, the proportion of rectum receiving 36.9 Gy, 46.2 Gy, 64.6 Gy, and 73.9 Gy was associated with the development of late GI toxicity (P<.05). The 5-year actuarial grade ≥2 GI toxicity was 27.3% in men with R64.6Gy ≥ 20% but only 6.0% in men with R64.6Gy < 20% (P=.016). Conclusions: Dose-escalated IMRT using a moderate hypofractionation regimen (72 Gy in 2.4-Gy fractions) can be delivered safely with limited grade 2 or 3 late toxicity. Minimizing the proportion of rectum that receives moderate and high dose decreases the risk of late rectal toxicity after this

Risk of Late Toxicity in Men Receiving Dose-Escalated Hypofractionated Intensity Modulated Prostate Radiation Therapy: Results From a Randomized Trial

International Nuclear Information System (INIS)

Hoffman, Karen E.; Voong, K. Ranh; Pugh, Thomas J.; Skinner, Heath; Levy, Lawrence B.; Takiar, Vinita; Choi, Seungtaek; Du, Weiliang; Frank, Steven J.; Johnson, Jennifer; Kanke, James; Kudchadker, Rajat J.; Lee, Andrew K.; Mahmood, Usama; McGuire, Sean E.; Kuban, Deborah A.

2014-01-01

Objective: To report late toxicity outcomes from a randomized trial comparing conventional and hypofractionated prostate radiation therapy and to identify dosimetric and clinical parameters associated with late toxicity after hypofractionated treatment. Methods and Materials: Men with localized prostate cancer were enrolled in a trial that randomized men to either conventionally fractionated intensity modulated radiation therapy (CIMRT, 75.6 Gy in 1.8-Gy fractions) or to dose-escalated hypofractionated IMRT (HIMRT, 72 Gy in 2.4-Gy fractions). Late (≥90 days after completion of radiation therapy) genitourinary (GU) and gastrointestinal (GI) toxicity were prospectively evaluated and scored according to modified Radiation Therapy Oncology Group criteria. Results: 101 men received CIMRT and 102 men received HIMRT. The median age was 68, and the median follow-up time was 6.0 years. Twenty-eight percent had low-risk, 71% had intermediate-risk, and 1% had high-risk disease. There was no difference in late GU toxicity in men treated with CIMRT and HIMRT. The actuarial 5-year grade ≥2 GU toxicity was 16.5% after CIMRT and 15.8% after HIMRT (P=.97). There was a nonsignificant numeric increase in late GI toxicity in men treated with HIMRT compared with men treated with CIMRT. The actuarial 5-year grade ≥2 GI toxicity was 5.1% after CIMRT and 10.0% after HIMRT (P=.11). In men receiving HIMRT, the proportion of rectum receiving 36.9 Gy, 46.2 Gy, 64.6 Gy, and 73.9 Gy was associated with the development of late GI toxicity (P<.05). The 5-year actuarial grade ≥2 GI toxicity was 27.3% in men with R64.6Gy ≥ 20% but only 6.0% in men with R64.6Gy < 20% (P=.016). Conclusions: Dose-escalated IMRT using a moderate hypofractionation regimen (72 Gy in 2.4-Gy fractions) can be delivered safely with limited grade 2 or 3 late toxicity. Minimizing the proportion of rectum that receives moderate and high dose decreases the risk of late rectal toxicity after this

Does providing prescription information or services improve medication adherence among patients discharged from the emergency department? A randomized controlled trial.

Science.gov (United States)

McCarthy, Melissa L; Ding, Ru; Roderer, Nancy K; Steinwachs, Donald M; Ortmann, Melinda J; Pham, Julius Cong; Bessman, Edward S; Kelen, Gabor D; Atha, Walter; Retezar, Rodica; Bessman, Sara C; Zeger, Scott L

2013-09-01

We determine whether prescription information or services improve the medication adherence of emergency department (ED) patients. Adult patients treated at one of 3 EDs between November 2010 and September 2011 and prescribed an antibiotic, central nervous system, gastrointestinal, cardiac, or respiratory drug at discharge were eligible. Subjects were randomly assigned to usual care or one of 3 prescription information or services intervention groups: (1) practical services to reduce barriers to prescription filling (practical prescription information or services); (2) consumer drug information from MedlinePlus (MedlinePlus prescription information or services); or (3) both services and information (combination prescription information or services). Self-reported medication adherence, measured by primary adherence (prescription filling) and persistence (receiving medicine as prescribed) rates, was determined during a telephone interview 1 week postdischarge. Of the 3,940 subjects enrolled and randomly allocated to treatment, 86% (N=3,386) completed the follow-up interview. Overall, primary adherence was 88% and persistence was 48%. Across the sites, primary adherence and persistence did not differ significantly between usual care and the prescription information or services groups. However, at site C, subjects who received the practical prescription information or services (odds ratio [OR]=2.4; 95% confidence interval [CI] 1.4 to 4.3) or combination prescription information or services (OR=1.8; 95% CI 1.1 to 3.1) were more likely to fill their prescription compared with usual care. Among subjects prescribed a drug that treats an underlying condition, subjects who received the practical prescription information or services were more likely to fill their prescription (OR=1.8; 95% CI 1.0 to 3.1) compared with subjects who received usual care. Prescription filling and receiving medications as prescribed was not meaningfully improved by offering patients patient

Glucosamine-containing supplement improves locomotor functions in subjects with knee pain: a randomized, double-blind, placebo-controlled study.

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Kanzaki, Noriyuki; Ono, Yoshiko; Shibata, Hiroshi; Moritani, Toshio

2015-01-01

The aim of this study was to investigate the ability of a glucosamine-containing supplement to improve locomotor functions in subjects with knee pain. A randomized, double-blind, placebo-controlled, parallel-group comparative study was conducted for 16 weeks in 100 Japanese subjects (age, 51.8±0.8 years) with knee pain. Subjects were randomly assigned to one of the two supplements containing 1) 1,200 mg of glucosamine hydrochloride, 60 mg of chondroitin sulfate, 45 mg of type II collagen peptides, 90 mg of quercetin glycosides, 10 mg of imidazole peptides, and 5 μg of vitamin D per day (GCQID group, n=50) or 2) a placebo (placebo group, n=50). Japanese Knee Osteoarthritis Measure, visual analog scale score, normal walking speed, and knee-extensor strength were measured to evaluate the effects of the supplement on knee-joint functions and locomotor functions. In subjects eligible for efficacy assessment, there was no significant group × time interaction, and there were improvements in knee-joint functions and locomotor functions in both groups, but there was no significant difference between the groups. In subjects with mild-to-severe knee pain at baseline, knee-extensor strength at week 8 (104.6±5.0% body weight vs 92.3±5.5% body weight, P=0.030) and the change in normal walking speed at week 16 (0.11±0.03 m/s vs 0.05±0.02 m/s, P=0.038) were significantly greater in the GCQID group than in the placebo group. Further subgroup analysis based on Kellgren-Lawrence (K-L) grade showed that normal walking speed at week 16 (1.36±0.05 m/s vs 1.21±0.02 m/s, Pknee pain, GCQID supplementation was effective for relieving knee pain and improving locomotor functions.

A prospective randomized evaluation of the prophylactic use of low-dose dopamine in cancer patients receiving interleukin-2.

Science.gov (United States)

Cormier, J N; Hurst, R; Vasselli, J; Lee, D; Kim, C J; McKee, M; Venzon, D; White, D; Marincola, F M; Rosenberg, S A

1997-07-01

The administration of high-dose interleukin-2 (IL-2) causes tumor regression in 17-25% of patients with metastatic melanoma or renal cell carcinoma. Renal dysfunction is a common dose-limiting toxicity of IL-2 administration, limiting 26% of treatment cycles. We have conducted a prospective randomized trial to evaluate whether the prophylactic administration of low-dose dopamine (2 mg/kg/min) can minimize renal toxicity and thus affect the amount of IL-2 administered. Forty-two patients were randomly assigned to receive systemic high-dose IL-2 with standard supportive measures (group A = 21 patients) or with the addition of prophylactic dopamine (group B = 21 patients) at 2 mg/kg/min. For patients in group B, dopamine was instituted 1 h before the initiation of IL-2 administration and was discontinued 6-12 h after the maximum number of doses of IL-2 were given. There was no difference in the amount of IL-2 administered for each course of therapy for groups A and B. Despite differences in urine flow (milliliters per kilogram per day), fluid balance (liters per day), and overall weight gain, prophylactic low-dose dopamine did not significantly alter maximum plasma urea or creatinine levels in group B when compared with the control group (group A). The overall toxicity profile considering all grade 3 and 4 toxicities for patients in groups A and B was comparable. Thus, there is no evidence to support the routine use of prophylactic low-dose dopamine in patients receiving high-dose IL-2.

A randomized, double-blind, placebo-controlled trial of a traditional herbal formula, Yukmijihwang-tang in elderly subjects with xerostomia.

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Han, Gajin; Ko, Seok-Jae; Kim, Juyeon; Oh, Ja-Young; Park, Jae-Woo; Kim, Jinsung

2016-04-22

Yukmijihwang-tang (YMJ) is a typical herbal formula to treat Yin-deficiency (YD) syndrome by enriching the fluid-humor of the body. YMJ has been used to treat dry mouth symptoms for hundreds of years in traditional East Asian medicine. Xerostomia, a subjective oral dryness, is common in the elderly and results in impaired quality of life. Many conventional treatments for xerostomia provide only temporary symptom relief, and have side effects. The aim of this study is to investigate the efficacy and safety of YMJ for the treatment of xerostomia in the elderly. This study was designed as a randomized, placebo-controlled, double-blinded, two center trial. Ninety-six subjects aged 60-80 years who had experienced xerostomia for at least 3 months and presented with score>40 on the visual analog scale (VAS) for subjective oral dryness were recruited and randomly allocated to YMJ and placebo groups. YMJ or placebo was administered to each group for 8 weeks (3g of YMJ or placebo, three times per day). The primary outcome was change of VAS for xerostomia from 0 to 8 weeks. VAS for xerostomia was decreased by 22.04±22.76 in the YMJ group and 23.58±23.04 in the placebo group. YMJ had no effect on xerostomia. However, participants with BMIs lower than 29.37kg/m(2) showed improvement of xerostomia after 8 weeks of treatment with YMJ compared to placebo. In addition, YMJ improved oral moisture, which is associated with subjective oral dryness in the YMJ group, and the relationship between VAS for xerostomia and YD was significant. A trend was observed in which YMJ improved oral moisture status and subjective oral dryness in elderly subjects with lower BMI and greater tendency toward YD. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Safety and pharmacokinetics of single and multiple intravenous bolus doses of diclofenac sodium compared with oral diclofenac potassium 50 mg: A randomized, parallel-group, single-center study in healthy subjects.

Science.gov (United States)

Munjal, Sagar; Gautam, Anirudh; Okumu, Franklin; McDowell, James; Allenby, Kent

2016-01-01

In a randomized, parallel-group, single-center study in 42 healthy adults, the safety and pharmacokinetic parameters of an intravenous formulation of 18.75 and 37.5 mg diclofenac sodium (DFP-08) following single- and multiple-dose bolus administration were compared with diclofenac potassium 50 mg oral tablets. Mean AUC0-inf values for a 50-mg oral tablet and an 18.75-mg intravenous formulation were similar (1308.9 [393.0]) vs 1232.4 [147.6]). As measured by the AUC, DFP-08 18.75 mg and 37.5 mg demonstrated dose proportionality for extent of exposure. One subject in each of the placebo and DFP-08 18.75-mg groups and 2 subjects in the DFP-08 37.5-mg group reported adverse events that were considered by the investigator to be related to the study drug. All were mild in intensity and did not require treatment. Two subjects in the placebo group and 1 subject in the DFP-08 18.75-mg group reported grade 1 thrombophlebitis; no subjects reported higher than grade 1 thrombophlebitis after receiving a single intravenous dose. The 18.75- and 37.5-mg doses of intravenous diclofenac (single and multiple) were well tolerated for 7 days. Additional efficacy and safety studies are required to fully characterize the product. © 2015, The American College of Clinical Pharmacology.

The Immediate Effects of Conventional Physical Therapy on the Knee Joint Load in Subjects with Moderate Knee Osteoarthritis; A Preliminary Single Blinded Randomized Control Trial

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Leila Fattahi

2015-12-01

Full Text Available Background: Subjects with knee osteoarthritis typically have higher knee adduction moment. Current research efforts are mainly focused on therapeutic procedures that potentially may modify disease progression. This preliminary study was designed as a single blind (examiner randomized control trial to investigate the impact of conventional physical therapy on pain, and knee joint load in subjects with moderate knee osteoarthritis. Methods: Twelve participants diagnosed with moderate knee OA were randomly assigned into control and intervention groups. Three-dimensional knee kinematic and kinetic data were recorded during the gait before and after 10 sessions of conventional physical therapy. In addition, pain intensity was evaluated by visual analog scale and pain subscale of KOOS questionnaire. The control group did not receive any intervention during the same period. Gait parameters were analyzed within and between groups using nonparametric tests. Results: There was a significant difference between groups in baseline KOOS-pain Score and ML knee force (P=0.048 and P=0.01. Immediately after ten sessions of physical therapy the initial (first peak of knee adduction moment was significantly (P=0.03 lower than that of the control group while the first and second peak of knee AP velocity were significantly (P=0.02, P=0.01 respectively higher. In the intervention group, the second peaks of vertical and anteroposterior (AP knee forces were strongly correlated with the pretest KOOS-pain Score (r=0.99 and r=0.98, P<0.001. Therefore a multivariate general linear model was adopted with adjustment to baseline KOOS-pain. By this adjustment, 51% alleviation of VAS pain score and 81% decrement of first peak of knee adduction moment in comparison to control group was statistically significant (P=0.02, P=0.03 respectively. Conclusion: It seems that ten sessions of conventional physical therapy may modify knee joint load in subjects with moderate knee

Effect of the cumin cyminum L. Intake on Weight Loss, Metabolic Profiles and Biomarkers of Oxidative Stress in Overweight Subjects: A Randomized Double-Blind Placebo-Controlled Clinical Trial.

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Taghizadeh, Mohsen; Memarzadeh, Mohammad Reza; Asemi, Zatollah; Esmaillzadeh, Ahmad

2015-01-01

The current study was performed to determine the effects of cumin cyminum L. intake on weight loss and metabolic profiles among overweight subjects. This randomized double-blind placebo-controlled clinical trial was conducted among 78 overweight subjects (male, n = 18; female, n = 60) aged 18-60 years old. Participants were randomly assigned into three groups to receive: (1) cumin cyminum L. capsule (n = 26); (2) orlistat120 capsule (n = 26) and (3) placebo (n = 26) three times a day for 8 weeks. Anthropometric measures and fasting blood samples were taken at baseline and after 8 weeks of intervention. Consumption of the Cuminum cyminum L. and orlistat120 resulted in a similar significant decrease in weight (-1.1 ± 1.2 and -0.9 ± 1.5 vs. 0.2 ± 1.5 kg, respectively, p = 0.002) and BMI (-0.4 ± 0.5 and -0.4 ± 0.6 vs. 0.1 ± 0.6 kg/m(2), respectively, p = 0.003) compared with placebo. In addition, taking Cuminum cyminum L., compared with orlistat and placebo, led to a significant reduction in serum insulin levels (-1.4 ± 4.5 vs. 1.3 ± 3.3 and 0.3 ± 2.2 µIU/ml, respectively, p = 0.02), HOMA-B (-5.4 ± 18.9 vs. 5.8 ± 13.3 and 1.0 ± 11.0, respectively, p = 0.02) and a significant rise in QUICKI (0.01 ± 0.01 vs. -0.005 ± 0.01 and -0.004 ± 0.01, respectively, p = 0.02). Taking cumin cyminum L. for eight weeks among overweight subjects had the same effects of orlistat120 on weight and BMI and beneficial effects on insulin metabolism compared with orlistat120 and placebo. © 2015 S. Karger AG, Basel.

Impact of chromium dinicocysteinate supplementation on inflammation, oxidative stress, and insulin resistance in type 2 diabetic subjects: an exploratory analysis of a randomized, double-blind, placebo-controlled study

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Zainulabedin M. Saiyed

2016-09-01

Full Text Available Background: Chromium dinicocysteinate (CDNC is a unique chromium complex consisting of chromium, niacin, and L-cysteine. Previous preclinical and clinical studies support the safety and efficacy of CDNC in modulating oxidative stress, vascular inflammation, and glycemia in type 2 diabetes. Objective: Herein, we report the results of several exploratory analyses conducted on type 2 diabetic subjects who previously participated in a 3-month randomized, double-blind, placebo-controlled trial and were treated with only metformin as standard diabetic care in addition to receiving the test supplementations. Design: Results from 43 metformin users, who were randomly assigned to receive either placebo (P, n=13, chromium picolinate (CP, 400 µg elemental Cr3+/day, n=12, or CDNC (400 µg elemental Cr3+/day, n=18, were analyzed for blood markers of vascular inflammation, insulin resistance, and oxidative stress at baseline and at 3 months of supplementation. Results: A statistically significant decrease in insulin resistance in the CDNC-supplemented cohort compared to placebo (p=0.01 was observed at 3 months. The CDNC group also demonstrated a significant reduction in insulin levels (p=0.03, protein carbonyl (p=0.02, and in TNF-α (p=0.03 compared to the placebo group. The CP group only showed a significant reduction in protein carbonyl levels (p=0.03 versus placebo. Conclusions: When controlling for diabetes medication, CDNC supplementation showed beneficial effects on blood markers of vascular inflammation, insulin resistance, and oxidative stress compared to placebo. The findings suggest that CDNC supplementation has potential as an adjunct therapy for individuals with type 2 diabetes.

The effect of Neuragen PN® on Neuropathic pain: A randomized, double blind, placebo controlled clinical trial

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Li Li

2010-05-01

Full Text Available Abstract Background A double blind, randomized, placebo controlled study to evaluate the safety and efficacy of the naturally derived topical oil, "Neuragen PN®" for the treatment of neuropathic pain. Methods Sixty participants with plantar cutaneous (foot sole pain due to all cause peripheral neuropathy were recruited from the community. Each subject was randomly assigned to receive one of two treatments (Neuragen PN® or placebo per week in a crossover design. The primary outcome measure was acute spontaneous pain level as reported on a visual analog scale. Results There was an overall pain reduction for both treatments from pre to post application. As compared to the placebo, Neuragen PN® led to significantly (p ® reported pain reduction within 30 minutes. This reduction within 30 minutes occurred in only twenty one of sixty (35.0% subjects receiving the placebo. In a break out analysis of the diabetic only subgroup, 94% of subjects in the Neuragen PN® group achieved pain reduction within 30 minutes vs 11.0% of the placebo group. No adverse events were observed. Conclusions This randomized, placebo controlled, clinical trial with crossover design revealed that the naturally derived oil, Neuragen PN®, provided significant relief from neuropathic pain in an all cause neuropathy group. Participants with diabetes within this group experienced similar pain relief. Trial registration ISRCTN registered: ISRCTN13226601

EFFECTIVENESS OF MEDIAL TO LATERAL TAPING WITH EXERCISE PROGRAMME IN SUBJECTS WITH LATERAL EPICONDYLITIS

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Bhavana Dattaram Desai

2014-06-01

Full Text Available Background: Medial to lateral tapping and exercise programme has been found to be effective in Lateral epicondylitis. The purpose to find the combined effect of Medial to lateral tapping with exercise programme for subjects with lateral epicondylitis on pain intensity and functional ability. Method: An experimental study design, selected 40 subjects with Lateral epicondylitis randomized 20 subjects each into Study and Control group. Control group received only exercise programme while study group received combined medial to lateral tapping with exercise programme thrice a week for 4 weeks. Pain intensity was measured using Visual analogue scale and functional ability was measured using Patient Rated Tennis Elbow Evaluation questionnaire before and after 4 weeks of treatment. Results: When the post-intervention means were compared between Study and Control group after 4 weeks of treatment found statistically significant difference in the improvement in outcomes measures in means of VAS and PRTEE before and after intervention within the groups. Conclusion: It is concluded that the Medial to lateral tapping with exercise programme is more effective than the exercise programme in reduction of pain and improve functional abilities for subjects with Lateral epicondylitis.

Phase 2, Dose-Ranging Study of Relebactam with Imipenem-Cilastatin in Subjects with Complicated Intra-abdominal Infection.

Science.gov (United States)

Lucasti, Christopher; Vasile, Liviu; Sandesc, Dorel; Venskutonis, Donatas; McLeroth, Patrick; Lala, Mallika; Rizk, Matthew L; Brown, Michelle L; Losada, Maria C; Pedley, Alison; Kartsonis, Nicholas A; Paschke, Amanda

2016-10-01

Relebactam (REL [MK-7655]) is a novel class A/C β-lactamase inhibitor intended for use with imipenem for the treatment of Gram-negative bacterial infections. REL restores imipenem activity against some resistant strains of Klebsiella and Pseudomonas In this multicenter, double-blind, controlled trial (NCT01506271), subjects who were ≥18 years of age with complicated intra-abdominal infection were randomly assigned (1:1:1) to receive 250 mg REL, 125 mg REL, or placebo, each given intravenously (i.v.) with 500 mg imipenem-cilastatin (IMI) every 6 h (q6h) for 4 to 14 days. The primary efficacy endpoint was the proportion of microbiologically evaluable (ME) subjects with a favorable clinical response at discontinuation of i.v. therapy (DCIV). A total of 351 subjects were randomized, 347 (99%) were treated, and 255 (73%) were ME at DCIV (55% male; mean age, 49 years). The most common diagnoses were complicated appendicitis (53%) and complicated cholecystitis (17%). Thirty-six subjects (13%) had imipenem-resistant Gram-negative infections at baseline. Both REL doses plus IMI were generally well tolerated and demonstrated safety profiles similar to that of IMI alone. Clinical response rates at DCIV were similar in subjects who received 250 mg REL plus IMI (96.3%) or 125 mg REL plus IMI (98.8%), and both were noninferior to IMI alone (95.2%; one-sided P imipenem exposure at the proposed dose of 500 mg IMI with 250 mg REL q6h provides coverage of >90% of carbapenem-resistant bacterial strains. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

A comparison of random walks in dependent random environments

NARCIS (Netherlands)

Scheinhardt, Willem R.W.; Kroese, Dirk

2015-01-01

Although the theoretical behavior of one-dimensional random walks in random environments is well understood, the actual evaluation of various characteristics of such processes has received relatively little attention. This paper develops new methodology for the exact computation of the drift in such

Mini-screw implant or transpalatal arch-mediated anchorage reinforcement during canine retraction: a randomized clinical trial.

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Sharma, Mohit; Sharma, Vineet; Khanna, Bharat

2012-06-01

To compare mesial movement of upper first molars during maxillary canine retraction using a pre-adjusted edgewise appliance provided by anchorage reinforcement and a transpalatal arch or mini-screw implant. Randomized clinical trial. Department of Orthodontics and Dentofacial Orthopedics, Armed Forces Medical College, Pune, India. From a cohort of subjects requiring the extraction of both upper first premolars and pre-adjusted edgewise appliances to correct their malocclusion, a total of 30 were randomly allocated to receive two different forms of anchorage reinforcement: group A--receiving mini-screw implant and group B--receiving a transpalatal arch Group A subjects received titanium mini-screw implants placed at the start of treatment between the maxillary second premolar and maxillary first molar. Maxillary second premolars were secured to the mini-screw implants using of 0.010-inch stainless steel ligature wire. Group B subjects received a custom-made transpalatal arch which was soldered to maxillary first molar bands. Active canine retraction was initiated in both groups on placement of a 0.019×0.025-inch stainless steel archwire using nickel titanium closed coil springs. Mesial movement of the upper first molars as measured on pre- (T1) and post-treatment (T2) lateral skull radiographs. The results showed that in group A the mean mesial movement of the first molars between T1 and T2 was 0.0 mm (SD 0.02; P = 0.90), whereas in Group B there was a mean forward movement of the first maolars of 2.48 mm (SD 0.71; Pimplants placed prior to levelling and aligning were able to provide absolute anchorage during maxillary canine retraction, in contrast to a transpalatal arch.

[Acupuncture therapy for the improvement of sleep quality of outpatients receiving methadone maintenance treatment: a randomized controlled trial].

Science.gov (United States)

Li, Yi; Liu, Xue-bing; Zhang, Yao

2012-08-01

To study the efficacy and safety of acupuncture therapy for the improvement of sleep quality of outpatients receiving methadone maintenance treatment (MMT). Using randomized double-blinded controlled design, seventy-five MMT outpatients with low sleep quality [score of Pittsburgh sleep quality index (PSQI) > or = 8], were randomly assigned to the acupuncture group (38 cases) and the sham-acupuncture group (37 cases). All patients maintained previous MMT. Acupuncture was applied to Baihui (GV20), Shenmen (bilateral, TF4), Shenting (GV24), Sanyinjiao (bilateral, SP6), and Sishencong (EX-HN1) in the acupuncture group. The same procedures were performed in the sham-acupuncture group, but not to the acupoints (5 mm lateral to the acupoints selected in the acupuncture group) with shallow needling technique. The treatment was performed 5 times each week for 8 successive weeks. The PSQI was assessed before treatment, at the end of the 2nd, 4th, 6th, and 8th week of the treatment. The detection ratio of low sleep quality and the incidence of adverse acupuncture reactions were compared between the two groups at the end of the 8th week. The overall PSQI score was obviously higher in the acupuncture group than in the sham-acupuncture group with statistical difference (P acupuncture group (60.53%, 23/38 cases) than in the sham-acupuncture group (83.78%, 31/37 cases) with statistical difference (P acupuncture reaction was 5.26% (2/38 cases) in the acupuncture group and 2.70% (1/37 cases) in the sham-acupuncture group respectively, showing no statistical difference (P > 0.05). Acupuncture therapy could effectively and safely improve the sleep quality of outpatients receiving MMT.

Task-Based Mirror Therapy Augmenting Motor Recovery in Poststroke Hemiparesis: A Randomized Controlled Trial.

Science.gov (United States)

Arya, Kamal Narayan; Pandian, Shanta; Kumar, Dharmendra; Puri, Vinod

2015-08-01

To establish the effect of the task-based mirror therapy (TBMT) on the upper limb recovery in stroke. A pilot, randomized, controlled, assessor-blinded trial was conducted in a rehabilitation institute. A convenience sample of 33 poststroke (mean duration, 12.5 months) hemiparetic subjects was randomized into 2 groups (experimental, 17; control, 16). The subjects were allocated to receive either TBMT or standard motor rehabilitation-40 sessions (5/week) for a period of 8 weeks. The TBMT group received movements using various goal-directed tasks and a mirror box. The movements were performed by the less-affected side superimposed on the affected side. The main outcome measures were Brunnstrom recovery stage (BRS) and Fugl-Meyer assessment (FMA)-FMA of upper extremity (FMA-UE), including upper arm (FMA-UA) and wrist-hand (FMA-WH). The TBMT group exhibited highly significant improvement on mean scores of FMA-WH (P hemiparesis. MT using tasks may be used as an adjunct in stroke rehabilitation. Copyright © 2015 National Stroke Association. Published by Elsevier Inc. All rights reserved.

No Acute Effects of Cannabidiol on the Sleep-Wake Cycle of Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study.

Science.gov (United States)

Linares, Ila M P; Guimaraes, Francisco S; Eckeli, Alan; Crippa, Ana C S; Zuardi, Antonio W; Souza, Jose D S; Hallak, Jaime E; Crippa, José A S

2018-01-01

Cannabidiol (CBD) is a component of Cannabis sativa that has a broad spectrum of potential therapeutic effects in neuropsychiatric and other disorders. However, few studies have investigated the possible interference of CBD on the sleep-wake cycle. The aim of the present study was to evaluate the effect of a clinically anxiolytic dose of CBD on the sleep-wake cycle of healthy subjects in a crossover, double-blind design. Twenty-seven healthy volunteers that fulfilled the eligibility criteria were selected and allocated to receive either CBD (300 mg) or placebo in the first night in a double-blind randomized design (one volunteer withdrew from the study). In the second night, the same procedure was performed using the substance that had not been administered in the previous occasion. CBD or placebo were administered 30 min before the start of polysomnography recordings that lasted 8 h. Cognitive and subjective measures were performed immediately after polysomnography to assess possible residual effects of CBD. The drug did not induce any significant effect ( p > 0.05). Different from anxiolytic and antidepressant drugs such as benzodiazepines and selective serotonin reuptake inhibitors, acute administration of an anxiolytic dose of CBD does not seem to interfere with the sleep cycle of healthy volunteers. The present findings support the proposal that CBD do not alter normal sleep architecture. Future studies should address the effects of CBD on the sleep-wake cycle of patient populations as well as in clinical trials with larger samples and chronic use of different doses of CBD. Such studies are desirable and opportune.

No Acute Effects of Cannabidiol on the Sleep-Wake Cycle of Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study

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Ila M. P. Linares

2018-04-01

Full Text Available Cannabidiol (CBD is a component of Cannabis sativa that has a broad spectrum of potential therapeutic effects in neuropsychiatric and other disorders. However, few studies have investigated the possible interference of CBD on the sleep-wake cycle. The aim of the present study was to evaluate the effect of a clinically anxiolytic dose of CBD on the sleep-wake cycle of healthy subjects in a crossover, double-blind design. Twenty-seven healthy volunteers that fulfilled the eligibility criteria were selected and allocated to receive either CBD (300 mg or placebo in the first night in a double-blind randomized design (one volunteer withdrew from the study. In the second night, the same procedure was performed using the substance that had not been administered in the previous occasion. CBD or placebo were administered 30 min before the start of polysomnography recordings that lasted 8 h. Cognitive and subjective measures were performed immediately after polysomnography to assess possible residual effects of CBD. The drug did not induce any significant effect (p > 0.05. Different from anxiolytic and antidepressant drugs such as benzodiazepines and selective serotonin reuptake inhibitors, acute administration of an anxiolytic dose of CBD does not seem to interfere with the sleep cycle of healthy volunteers. The present findings support the proposal that CBD do not alter normal sleep architecture. Future studies should address the effects of CBD on the sleep-wake cycle of patient populations as well as in clinical trials with larger samples and chronic use of different doses of CBD. Such studies are desirable and opportune.

Fast state estimation subject to random data loss in discrete-time nonlinear stochastic systems

Science.gov (United States)

Mahdi Alavi, S. M.; Saif, Mehrdad

2013-12-01

This paper focuses on the design of the standard observer in discrete-time nonlinear stochastic systems subject to random data loss. By the assumption that the system response is incrementally bounded, two sufficient conditions are subsequently derived that guarantee exponential mean-square stability and fast convergence of the estimation error for the problem at hand. An efficient algorithm is also presented to obtain the observer gain. Finally, the proposed methodology is employed for monitoring the Continuous Stirred Tank Reactor (CSTR) via a wireless communication network. The effectiveness of the designed observer is extensively assessed by using an experimental tested-bed that has been fabricated for performance evaluation of the over wireless-network estimation techniques under realistic radio channel conditions.

Time domain simulation of the response of geometrically nonlinear panels subjected to random loading

Science.gov (United States)

Moyer, E. Thomas, Jr.

1988-01-01

The response of composite panels subjected to random pressure loads large enough to cause geometrically nonlinear responses is studied. A time domain simulation is employed to solve the equations of motion. An adaptive time stepping algorithm is employed to minimize intermittent transients. A modified algorithm for the prediction of response spectral density is presented which predicts smooth spectral peaks for discrete time histories. Results are presented for a number of input pressure levels and damping coefficients. Response distributions are calculated and compared with the analytical solution of the Fokker-Planck equations. RMS response is reported as a function of input pressure level and damping coefficient. Spectral densities are calculated for a number of examples.

Effects of vitamin D supplementation and exercise training on physical performance in Chilean vitamin D deficient elderly subjects.

Science.gov (United States)

Bunout, Daniel; Barrera, Gladys; Leiva, Laura; Gattas, Vivien; de la Maza, María Pía; Avendaño, Marcelo; Hirsch, Sandra

2006-08-01

The aim was to assess the effects of resistance training and vitamin D supplementation on physical performance of healthy elderly subjects. Ninety-six subjects, aged 70 years or more with 25 OH vitamin D levels of 16 ng/ml or less, were randomized to a resistance training or control group. Trained and control groups were further randomized to receive in a double blind fashion, vitamin D 400 IU plus 800 mg of calcium per day or calcium alone. Subjects were followed for nine months. Serum 25 OH vitamin D increased from 12.4+/-2.2 to 25.8+/-6.5 ng/ml among subjects supplemented with vitamin D. Trained subjects had significant improvements in quadriceps muscle strength, the short physical performance test and timed up and go. The latter improved more in trained subjects supplemented with vitamin D. At the end of the follow up, gait speed was higher among subjects supplemented with vitamin (whether trained or not) than in non-supplemented subjects (838+/-147 and 768+/-127 m/12 min, respectively, p=0.02). Romberg ratio was lower among supplemented controls than non-supplemented trained subjects (128+/-40% and 144+/-37%, respectively, p=0.05). In conclusion, vitamin D supplementation improved gait speed and body sway, and training improved muscle strength.

A Solution Method for Linear and Geometrically Nonlinear MDOF Systems with Random Properties subject to Random Excitation

DEFF Research Database (Denmark)

Micaletti, R. C.; Cakmak, A. S.; Nielsen, Søren R. K.

structural properties. The resulting state-space formulation is a system of ordinary stochastic differential equations with random coefficient and deterministic initial conditions which are subsequently transformed into ordinary stochastic differential equations with deterministic coefficients and random......A method for computing the lower-order moments of randomly-excited multi-degree-of-freedom (MDOF) systems with random structural properties is proposed. The method is grounded in the techniques of stochastic calculus, utilizing a Markov diffusion process to model the structural system with random...... initial conditions. This transformation facilitates the derivation of differential equations which govern the evolution of the unconditional statistical moments of response. Primary consideration is given to linear systems and systems with odd polynomial nonlinearities, for in these cases...

Pharmacokinetic Effects of Antidrug Antibodies Occurring in Healthy Subjects After a Single Dose of Intravenous Infliximab.

Science.gov (United States)

Ehrenpreis, Eli D

2017-12-01

Infliximab pharmacokinetic studies have been performed in patients receiving chronic infliximab therapy. In these patients, infliximab antidrug antibodies (ADAs) increase infliximab clearance and decrease serum levels and drug efficacy. This study analyzed the pharmacokinetic effect of infliximab ADAs in healthy subjects receiving a single dose of intravenous infliximab. Data were obtained from a single-blind, parallel-group, single-dose study of healthy subjects receiving 5 mg/kg of intravenous SB2 (infliximab biosimilar), EU-sourced Remicade (EU-IFX) or US-sourced Remicade (US-IFX). Serum infliximab was measured at 1, 2, 3, 6, 12, 24, 48, and 72 h and at 5, 7, 14, 21, 28, 42, 56, and 70 days after administration. ADAs were measured pre-dose and at 29 and 71 days. Data from the first ten subjects randomized to each treatment arm were utilized for this study. A two-compartment model of the serum infliximab vs. time curve was developed using nonlinear regression. At 10 weeks, 11 subjects (37%) developed ADAs. ADAs were detected in four subjects after SB2, one subject after EU-IFX, and six subjects after US-IFX infusion. Of these, neutralizing antibodies occurred in one subject after SB2, in no subjects after EU-IFX, and in three subjects after US-IFX infusion. Infliximab clearance was increased in subjects with ADAs vs. those without ADAs (12.89 ± 2.69 vs. 9.90 ± 1.74 ml/h; p ADAs (282.4 ± 56.4 vs. 343.3 ± 61.9 h; p ADAs are common in healthy subjects after a single intravenous dose of infliximab and result in faster infliximab clearance, shorter elimination time, and lower serum infliximab levels. These data confirm that ADAs are common with biologic therapy and significantly impact the efficacy of these drugs.

The effect of baclofen and diazepam on motor skill acquisition in healthy subjects

DEFF Research Database (Denmark)

Willerslev-Olsen, Maria; Lundbye-Jensen, Jesper; Petersen, Tue Hvass

2011-01-01

investigated the influence of baclofen and diazepam on acquisition of a visuomotor skill. The study was designed as a semi-randomized, double-blinded, placebo-controlled, crossover study in 16 healthy human subjects. The motor skill task required the subjects to match a given force trajectory by increasing...... that diazepam and baclofen interfere with the acquisition of a motor skill by disrupting some of the neuroplastic changes that are involved in improved motor performance. This suggests that antispastic treatment should be used with caution in subjects receiving concomitant physiotherapy.......Antispastic medication is often used in the clinic together with physiotherapy. However, some of the antispastic drugs, e.g., baclofen and diazepam, may influence the plastic mechanisms that are necessary for motor learning and hence efficient physiotherapy. In the present study, we consequently...

Enhancing trunk stability in acute poststroke subjects using physioball exercise and proprioceptive neuromuscular facilitation technique: A pilot randomized controlled trial

Directory of Open Access Journals (Sweden)

Ravichandran Hariharasudhan

2016-01-01

Full Text Available Background: Stroke is one of the leading causes of death and disability worldwide. Poststroke, most survivors experience trunk control impairment and instability. Previous works on exercise on an unstable surface to improve trunk stability in nonstroke population had proven effective. Thus, physioball exercises (PBEs in poststroke subjects may be useful in the recovery of trunk stability and thereby reduce disability. We hypothesize that PBE is feasible and effective in enhancing trunk stability. Aims: To test the feasibility and successful implementation of conducting a randomized controlled study to assess the clinical effectiveness of PBE and proprioceptive neuromuscular facilitation (PNF technique to enhance trunk control in poststroke subjects. Methods: This study was conducted in a stroke unit of Global Hospitals and Health City, Chennai, India. Thirty patients with the first onset of stroke within 40 days of stroke duration, lesion to one side, and ability to sit independently with or without arm support for 15 days were recruited. All thirty poststroke subjects were randomized either into PBE group or PNF group, and outcome assessors involved in the trail were blinded to allocation. PBE group performed task-oriented activities on an unstable surface and PNF group were treated with PNF-specific trunk stability exercise program for 4 weeks (30 min/day, 5 times/week. Trunk impairment scale (TIS was used as a main outcome measure. Results: Data were analyzed using Wilcoxon signed rank sum test and Mann–Whitney U-test for intra- and inter-group comparison. The baseline characteristics between both groups were statistically nonsignificant. Within groups, there were significant improvements between baseline and at 4 weeks in the measure of TIS. In addition, PBE group showed a significant increase in trunk control (mean 2.33, 95% confidence interval 1.14-3.52, P = 0.002 than the PNF subject. Conclusion: This pilot randomized controlled trial

Efficacy of ankle control balance training on postural balance and gait ability in community-dwelling older adults: a single-blinded, randomized clinical trial

OpenAIRE

Lee, Kyeongjin; Lee, Yong Woo

2017-01-01

[Purpose] This study was conducted to investigate the effects of ankle control balance training (ACBT) on postural balance and gait ability in community-dwelling older adults. [Subjects and Methods] Fifty-four subjects were randomly divided into two groups, with 27 subjects in the ACBT group and 27 subjects in the control group. Subjects in the ACBT group received ACBT for 60 minutes, twice per week for 4 weeks, and all subjects had undergone fall prevention education for 60 minutes, once per...

Resveratrol does not influence metabolic risk markers related to cardiovascular health in overweight and slightly obese subjects: a randomized, placebo-controlled crossover trial.

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Sanne M van der Made

Full Text Available In vitro and animal studies have shown positive effects of resveratrol on lipid and lipoprotein metabolism, but human studies specifically designed to examine these effects are lacking.The primary outcome parameter of this study in overweight and slightly obese subjects was the effect of resveratrol on apoA-I concentrations. Secondary outcome parameters were effects on other markers of lipid and lipoprotein metabolism, glucose metabolism, and markers for inflammation and endothelial function.This randomized, placebo-controlled crossover study was conducted in 45 overweight and slightly obese men (n = 25 and women (n = 20 with a mean age of 61 ± 7 years. Subjects received in random order resveratrol (150 mg per day or placebo capsules for 4 weeks, separated by a 4-week wash-out period. Fasting blood samples were collected at baseline and at the end of each intervention period.Compliance was excellent as indicated by capsule count and changes in resveratrol and dihydroresveratrol concentrations. No difference between resveratrol and placebo was found in any of the fasting serum or plasma metabolic risk markers (mean ± SD for differences between day 28 values of resveratrol vs. placebo: apoA-I; 0.00 ± 0.12 g/L (P = 0.791, apoB100; -0.01 ± 0.11 g/L (P = 0.545, HDL cholesterol; 0.00 ± 0.09 mmol/L (P = 0.721, LDL cholesterol -0.03 ± 0.57 mmol/L (P = 0.718, triacylglycerol; 0.10 ± 0.54 mmol/L (P = 0.687, glucose; -0.08 ± 0.28 mmol/L (P = 0.064, insulin; -0.3 ± 2.5 mU/L (P = 0.516. Also, no effects on plasma markers for inflammation and endothelial function were observed. No adverse events related to resveratrol intake were observed.150 mg of daily resveratrol intake for 4 weeks does not change metabolic risk markers related to cardiovascular health in overweight and slightly obese men and women. Effects on glucose metabolism warrant further study.ClinicalTrials.gov NCT01364961.

The Effects of Curcumin and Curcumin-Phospholipid Complex on the Serum Pro-oxidant-Antioxidant Balance in Subjects with Metabolic Syndrome.

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Ghazimoradi, Maryam; Saberi-Karimian, Maryam; Mohammadi, Farzane; Sahebkar, Amirhossein; Tavallaie, Shima; Safarian, Hamideh; Ferns, Gordon A; Ghayour-Mobarhan, Majid; Moohebati, Mohsen; Esmaeili, Habibollah; Ahmadinejad, Malihe

2017-11-01

Metabolic syndrome (MetS) is defined by a clustering of metabolic and anthropometric abnormalities and is associated by an increased risk of cardiovascular disease. We have investigated the effect of curcumin supplementation on the serum pro-oxidant-antioxidant balance (PAB) in patients with MetS. This double-blind, randomized, placebo-controlled trial was conducted over 6 weeks. Subjects (n = 120) were randomly allocated to one of three groups (curcumin, phospholipidated curcumin, and placebo). The curcumin group received 1 g/day of simple curcumin, the phospholipidated curcumin group received 1 g/day of phospholipidated curcumin (containing 200 mg of pure curcumin), and the control group received 1 g/day of placebo. Serum PAB was measured before and after the intervention (at baseline and at 6 weeks). Data analyses were performed using spss software (version 16.0). Serum PAB increased significantly in the curcumin group (p curcumin group, elevation of PAB level was not significant (p = 0.053). The results of our study did not suggest any improvement of PAB following supplementation with curcumin in MetS subjects. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

[Research on Chinese orthodontic specialists' subjective evaluation of orthodontic treatment outcome].

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Song, Guang-ying; Zhao, Zhi-he; Ding, Yin; Bai, Yu-xing; Wang, Lin; He, Hong; Qian, Yu-fen; Li, Wei-ran; Xu, Tian-min

2012-03-01

To analyze the results of multiple Chinese orthodontic specialists' subjective evaluation of orthodontic treatment outcome, to investigate the relevance of different experiment items and to explore the weight of each monomial material. As a randomized clinical trial, with six orthodontic treatment centers and Angle's classification being regarded as two stratification factors, it contained 108 cases with integrity data, which was random extracted from 2383 cases that received orthodontic treatment in six orthodontic treatment centers during the past five years, gathering post-treatment study casts, cephalometrics and photographs of 48 cases as the research subject. Similarly taking Angle's classification as a stratification factor, 108 cases were randomly divided into 9 groups. The randomization of sampling and grouping were both generated by a pseudo-random number generator. According to the monomial and combined subjects, 69 orthodontic specialists were regarded as the raters to rank the 12 cases in each group, and to judge whether the case was qualified. Correlation analysis: the Spearman r between Post-M + C and Post-M + C + P and the Spearman r between Post-M + P and Post-M + C + P were both greater than 0.950. The Spearman r between Post-M and Post-P and the Spearman r between Post-M and Post-C were about 0.300. The Spearman r between Post-P and Post-C was 0.505. Regression analysis: the linear regression results: M + C = 0.782M + 0.308C - 0.150, M + P = 0.804M + 0.233P - 0.091, M + C + P = 0.764M + 0.243P + 0.131C - 0.291. The r(2) of above three models was greater than 0.9. It was applicable to use M + C and M + P instead of M + C + P. Study casts could not replace cephalometrics or photographs when doing subjective evaluation. Cephalometrics and photographs could not substitute for each other either. In the combined materials evaluation, model accounted for the largest percentage. Based on the regression model, for the greater part, the integration of

Effectiveness of low-dose doxycycline (LDD on clinical symptoms of Sjögren's Syndrome: a randomized, double-blind, placebo controlled cross-over study

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Vuotila Tuija

2007-12-01

Full Text Available Abstract Background Matrix metalloproteinases (MMPs are proteolytic enzymes that may contribute to tissue destruction in Sjögren's syndrome (SS. Low-dose doxycycline (LDD inhibits MMPs. We evaluated the efficacy of LDD for the subjective symptoms in primary SS patients. This was a randomized, double blind, placebo controlled cross-over study. 22 patients were randomly assigned to receive either 20 mg LDD or matching placebo twice a day for 10 weeks. The first medication period was followed by 10-week washout period, after which the patient received either LDD or placebo, depending on the first drug received, followed by the second washout period. Stimulated saliva flow rates and pH were measured before and after one and ten weeks of each medication and after washout periods. VAS scale was used to assess the effect of LDD and placebo on following six subjective symptoms: xerostomia; xerophtalmia; difficulty of swallowing; myalgia; arthralgia; and fatigue. The effect was evaluated for each medication and washout period separately. Results Overall, the effects of medications on subjective symptoms were minor. Wilcoxon test demonstrated increased fatigue with LDD during medication (p Conclusion LDD may not be useful in reducing the primary SS symptoms.

Facilitators and barriers influencing the readiness to receive dental implants in a geriatric institutionalised population-A randomized non-invasive interventional study.

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Merz, Miriam A; Terheyden, Hendrik; Huber, Christian G; Seixas, Azizi A; Schoetzau, Andreas; Schneeberger, Andres R

2017-09-01

Although elderly people have many serious dental issues and are in need of prosthesis, few opt for dental implants. The aim of this study was to investigate barriers that prevent elderly people from receiving dental implants. Specifically, we examined (i) whether the message was delivered before or after the interview had an impact, and (ii) whether it did matter who delivered the message. Sixty-six residents from seven residential homes in the Canton of Grisons, Switzerland were included. The sample was randomized to a treatment group that received comprehensive education about dental implants before the interview and a control group that received education after completing the questionnaire. The sample consisted of 54 women (81.8%) and 12 males (18.2%) with an average age of 86.2 years. Education before the interview did not show any impact on the attitude towards dental implants. Main reasons for a negative attitude towards implants were old age and high costs. Participants who received information about implants from their relatives and their own dentist and not from the study dentist were significantly more willing to receive implants. Providing an adequate education about benefits and risks of receiving dental implants does not change the attitude towards dental implants. The source of information/messenger does influence attitudes towards implants. If the person delivering the education and information is a relative or a known medical person, the person's attitude is more likely to change as compared to people receiving the information from an unrelated person. © 2017 John Wiley & Sons A/S and The Gerodontology Association. Published by John Wiley & Sons Ltd.

Cranberry juice concentrate does not significantly decrease the incidence of acquired bacteriuria in female hip fracture patients receiving urine catheter: a double-blind randomized trial

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Gunnarsson AK

2017-01-01

Full Text Available Anna-Karin Gunnarsson,1 Lena Gunningberg,2 Sune Larsson,1 Kenneth B Jonsson1 1Institution of Surgical Sciences, Uppsala University, Uppsala, Sweden; 2Institution of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden Background: Urinary tract infection (UTI is a common complication among patients with hip fractures. Receiving an indwelling urinary catheter is a risk factor for developing UTIs. Treatment of symptomatic UTIs with antibiotics is expensive and can result in the development of antimicrobial resistance. Cranberries are thought to prevent UTI. There is no previous research on this potential effect in patients with hip fracture who receive urinary catheters. Aim: The aim of this study is to investigate whether intake of cranberry juice concentrate preoperatively decreases the incidence of postoperative UTIs in hip fracture patients that received a urinary catheter. Design: This study employed a randomized, placebo-controlled double-blind trial. Method: Female patients, aged 60 years and older, with hip fracture (n=227 were randomized to receive cranberry or placebo capsules daily, from admission, until 5 days postoperatively. Urine cultures were obtained at admission, 5 and 14 days postoperatively. In addition, Euro Qual five Dimensions assessments were performed and patients were screened for UTI symptoms. Result: In the intention-to-treat analysis, there was no difference between the groups in the proportion of patients with hospital-acquired postoperative positive urine cultures at any time point. When limiting the analysis to patients that ingested at least 80% of the prescribed capsules, 13 of 33 (39% in the placebo group and 13 of 47 (28% in the cranberry group (P=0.270 had a positive urine culture at 5 days postoperatively. However, this difference was not statistically significant (P=0.270. Conclusion: Cranberry concentrate does not seem to effectively prevent UTIs in female patients with hip fracture and

Impact of Virgin Olive Oil and Phenol-Enriched Virgin Olive Oils on the HDL Proteome in Hypercholesterolemic Subjects: A Double Blind, Randomized, Controlled, Cross-Over Clinical Trial (VOHF Study.

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Anna Pedret

Full Text Available The effects of olive oil phenolic compounds (PCs on HDL proteome, with respect to new aspects of cardioprotective properties, are still unknown. The aim of this study was to assess the impact on the HDL protein cargo of the intake of virgin olive oil (VOO and two functional VOOs, enriched with their own PCs (FVOO or complemented with thyme PCs (FVOOT, in hypercholesterolemic subjects. Eligible volunteers were recruited from the IMIM-Hospital del Mar Medical Research Institute (Spain from April 2012 to September 2012. Thirty-three hypercholesterolemic participants (total cholesterol >200 mg/dL; 19 men and 14 women; aged 35 to 80 years were randomized in the double-blind, controlled, cross-over VOHF clinical trial. The subjects received for 3 weeks 25 mL/day of: VOO, FVOO, or FVOOT. Using a quantitative proteomics approach, 127 HDL-associated proteins were identified. Among these, 15 were commonly differently expressed after the three VOO interventions compared to baseline, with specific changes observed for each intervention. The 15 common proteins were mainly involved in the following pathways: LXR/RXR activation, acute phase response, and atherosclerosis. The three VOOs were well tolerated by all participants. Consumption of VOO, or phenol-enriched VOOs, has an impact on the HDL proteome in a cardioprotective mode by up-regulating proteins related to cholesterol homeostasis, protection against oxidation and blood coagulation while down-regulating proteins implicated in acute-phase response, lipid transport, and immune response. The common observed protein expression modifications after the three VOOs indicate a major matrix effect.International Standard Randomized Controlled Trials ISRCTN77500181.

Impact of Virgin Olive Oil and Phenol-Enriched Virgin Olive Oils on the HDL Proteome in Hypercholesterolemic Subjects: A Double Blind, Randomized, Controlled, Cross-Over Clinical Trial (VOHF Study).

Science.gov (United States)

Pedret, Anna; Catalán, Úrsula; Fernández-Castillejo, Sara; Farràs, Marta; Valls, Rosa-M; Rubió, Laura; Canela, Núria; Aragonés, Gerard; Romeu, Marta; Castañer, Olga; de la Torre, Rafael; Covas, Maria-Isabel; Fitó, Montse; Motilva, Maria-José; Solà, Rosa

2015-01-01

The effects of olive oil phenolic compounds (PCs) on HDL proteome, with respect to new aspects of cardioprotective properties, are still unknown. The aim of this study was to assess the impact on the HDL protein cargo of the intake of virgin olive oil (VOO) and two functional VOOs, enriched with their own PCs (FVOO) or complemented with thyme PCs (FVOOT), in hypercholesterolemic subjects. Eligible volunteers were recruited from the IMIM-Hospital del Mar Medical Research Institute (Spain) from April 2012 to September 2012. Thirty-three hypercholesterolemic participants (total cholesterol >200 mg/dL; 19 men and 14 women; aged 35 to 80 years) were randomized in the double-blind, controlled, cross-over VOHF clinical trial. The subjects received for 3 weeks 25 mL/day of: VOO, FVOO, or FVOOT. Using a quantitative proteomics approach, 127 HDL-associated proteins were identified. Among these, 15 were commonly differently expressed after the three VOO interventions compared to baseline, with specific changes observed for each intervention. The 15 common proteins were mainly involved in the following pathways: LXR/RXR activation, acute phase response, and atherosclerosis. The three VOOs were well tolerated by all participants. Consumption of VOO, or phenol-enriched VOOs, has an impact on the HDL proteome in a cardioprotective mode by up-regulating proteins related to cholesterol homeostasis, protection against oxidation and blood coagulation while down-regulating proteins implicated in acute-phase response, lipid transport, and immune response. The common observed protein expression modifications after the three VOOs indicate a major matrix effect. International Standard Randomized Controlled Trials ISRCTN77500181.

Single- and multiple-dose pharmacokinetics, pharmacodynamics, and safety of apixaban in healthy Chinese subjects

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Cui Y

2013-12-01

Full Text Available Yimin Cui,1 Yan Song,2 Jessie Wang,2 Zhigang Yu,2 Alan Schuster,2 Yu Chen Barrett,2 Charles Frost2 1Peking University First Hospital, Beijing, People's Republic of China; 2Bristol-Myers Squibb, Princeton, NJ, USA Background: The pharmacokinetics (PK, pharmacodynamics (PD, and safety of apixaban were assessed in healthy Chinese subjects in this randomized, placebo-controlled, double-blind, single-sequence, single- and multiple-dose study. Subjects and methods: Eighteen subjects 18–45 years of age were randomly assigned (2:1 ratio to receive apixaban or matched placebo. Subjects received a single 10 mg dose of apixaban or placebo on day 1, followed by 10 mg apixaban or placebo twice daily for 6 days (days 4–9. The PK and PD of apixaban were assessed by collecting plasma samples for 72 hours following the dose on day 1 and the morning dose on day 9, and measuring apixaban concentration and anti-Xa activity. Safety was assessed via physical examinations, vital sign measurements, electrocardiograms, and clinical laboratory evaluations. Results: PK analysis showed similar characteristics of apixaban after single and multiple doses, including a median time to maximum concentration of ~3 hours, mean elimination half-life of ~11 hours, and renal clearance of ~1.2 L/hour. The accumulation index was 1.7, consistent with twice-daily dosing and the observed elimination half-life. Single-dose data predict multiple-dose PK, therefore apixaban PK are time-independent. The relationship between anti-Xa activity and plasma apixaban concentrations appears to be linear. Apixaban was safe and well tolerated, with no bleeding-related adverse events reported. Conclusion: Apixaban was safe and well tolerated in healthy Chinese subjects. Apixaban PK and PD were predictable and consistent with findings from previous studies in Asian and non-Asian subjects. The administration of apixaban does not require any dose modification based on race. Keywords: apixaban, oral

Quantifying and Characterizing Tonic Thermal Pain Across Subjects From EEG Data Using Random Forest Models.

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Vijayakumar, Vishal; Case, Michelle; Shirinpour, Sina; He, Bin

2017-12-01

Effective pain assessment and management strategies are needed to better manage pain. In addition to self-report, an objective pain assessment system can provide a more complete picture of the neurophysiological basis for pain. In this study, a robust and accurate machine learning approach is developed to quantify tonic thermal pain across healthy subjects into a maximum of ten distinct classes. A random forest model was trained to predict pain scores using time-frequency wavelet representations of independent components obtained from electroencephalography (EEG) data, and the relative importance of each frequency band to pain quantification is assessed. The mean classification accuracy for predicting pain on an independent test subject for a range of 1-10 is 89.45%, highest among existing state of the art quantification algorithms for EEG. The gamma band is the most important to both intersubject and intrasubject classification accuracy. The robustness and generalizability of the classifier are demonstrated. Our results demonstrate the potential of this tool to be used clinically to help us to improve chronic pain treatment and establish spectral biomarkers for future pain-related studies using EEG.

Effect of baking process on postprandial metabolic consequences: randomized trials in normal and type 2 diabetic subjects.

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Rizkalla, S W; Laromiguiere, M; Champ, M; Bruzzo, F; Boillot, J; Slama, G

2007-02-01

To determine the impact of the form, fibre content, baking and processing on the glycaemic, insulinaemic and lipidaemic responses of different French breads. First study: Nine healthy subjects were randomized to consume in a crossover design one of six kinds of French bread (each containing 50 g available carbohydrate): classic baguette, traditional baguette, loaf of wholemeal bread (WM-B), loaf of bread fermented with yeast or with leaven, a sandwich and a glucose challenge as reference. The glycaemic index (GI) values ranged from 57+/-9% (mean+/-s.e.m.), for the traditional baguette, to 85+/-27% for the WM-B. No significant difference was found among the different tested bread. The insulinaemic index (II), however, of the traditional baguette and of the bread fermented with leaven were lower than the other breads (analysis of variance: Pvarieties of French bread (the TB) have lower II, in healthy subjects, and lower GI, in type 2 diabetic subjects, than that of the other varieties. These results might be due to bread processing difference rather than fibre content. Supported by grants from the National French Milling Association.

Restorations in abrasion/erosion cervical lesions: 8-year results of a triple blind randomized controlled trial.

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Dall'Orologio, Giovanni Dondi; Lorenzi, Roberta

2014-10-01

An equivalence randomized controlled trial within the subject was organized to evaluate the clinical long-term success of a new 2-step etch & rinse adhesive and a new nano-filled ormocer. 50 subjects, 21 males and 29 females aged between 21 and 65, were randomized to receive 150 restorations, 100 with the new restorative material, 50 with the composite as control, placed in non-carious cervical lesions with the same bonding system. The main outcome measure was the cause of failure at 8 years. Randomization was number table-generated, with allocation concealment by opaque sequentially numbered sealed and stapled envelopes. Subjects, examiner, and analyst were blinded to group assignment. Two interim analyses were performed. Data were analyzed by ANOVA and Cox test (P failures in the experimental group and four failures in the control group. The cumulative loss rate was 7% for both restorative materials, with the annual failure lower than 1%, without any statistically significant difference. There were two key elements of failure: the presence of sclerotic dentin and the relationship between lesion and gingival margin.

Effects of social approval bias on self-reported fruit and vegetable consumption: a randomized controlled trial

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Marcus Al C

2008-06-01

Full Text Available Abstract Background Self-reports of dietary intake in the context of nutrition intervention research can be biased by the tendency of respondents to answer consistent with expected norms (social approval bias. The objective of this study was to assess the potential influence of social approval bias on self-reports of fruit and vegetable intake obtained using both food frequency questionnaire (FFQ and 24-hour recall methods. Methods A randomized blinded trial compared reported fruit and vegetable intake among subjects exposed to a potentially biasing prompt to that from control subjects. Subjects included 163 women residing in Colorado between 35 and 65 years of age who were randomly selected and recruited by telephone to complete what they were told would be a future telephone survey about health. Randomly half of the subjects then received a letter prior to the interview describing this as a study of fruit and vegetable intake. The letter included a brief statement of the benefits of fruits and vegetables, a 5-A-Day sticker, and a 5-a-Day refrigerator magnet. The remainder received the same letter, but describing the study purpose only as a more general nutrition survey, with neither the fruit and vegetable message nor the 5-A-Day materials. Subjects were then interviewed on the telephone within 10 days following the letters using an eight-item FFQ and a limited 24-hour recall to estimate fruit and vegetable intake. All interviewers were blinded to the treatment condition. Results By the FFQ method, subjects who viewed the potentially biasing prompts reported consuming more fruits and vegetables than did control subjects (5.2 vs. 3.7 servings per day, p Conclusion Self-reports of fruit and vegetable intake using either a food frequency questionnaire or a limited 24-hour recall are both susceptible to substantial social approval bias. Valid assessments of intervention effects in nutritional intervention trials may require objective measures of

Pen needle design influences ease of insertion, pain, and skin trauma in subjects with type 2 diabetes

DEFF Research Database (Denmark)

Præstmark, Kezia A; Jensen, Morten L; Berg Madsen, Nils

2016-01-01

subject and in random order. Penetration force (PF) through the skin, pain perception on 100 mm visual analog scale, and change in skin blood perfusion (SBP) were quantified after the insertions. RESULTS: Needle diameter was positively related to PF and SBP (ptrend relation...... of insertion, pain and skin trauma. RESEARCH DESIGN AND METHODS: 30 subjects with injection-treated type 2 diabetes and body mass index 25-35 kg/m(2) were included in the single-blinded study. Each subject received abdominal insertions with 18 different types of needles. All needles were tested twice per....... Lack of needle lubrication and small 'needle hooks' increased PF and SBP (pskin and in polyurethane rubber were linearly related, and pain outcome...

Extubation process in bed-ridden elderly intensive care patients receiving inspiratory muscle training: a randomized clinical trial.

Science.gov (United States)

Cader, Samária Ali; de Souza Vale, Rodrigo Gomes; Zamora, Victor Emmanuel; Costa, Claudia Henrique; Dantas, Estélio Henrique Martin

2012-01-01

The purpose of this study was to evaluate the extubation process in bed-ridden elderly intensive care patients receiving inspiratory muscle training (IMT) and identify predictors of successful weaning. Twenty-eight elderly intubated patients in an intensive care unit were randomly assigned to an experimental group (n = 14) that received conventional physiotherapy plus IMT with a Threshold IMT(®) device or to a control group (n = 14) that received only conventional physiotherapy. The experimental protocol for muscle training consisted of an initial load of 30% maximum inspiratory pressure, which was increased by 10% daily. The training was administered for 5 minutes, twice daily, 7 days a week, with supplemental oxygen from the beginning of weaning until extubation. Successful extubation was defined by the ventilation time measurement with noninvasive positive pressure. A vacuum manometer was used for measurement of maximum inspiratory pressure, and the patients' Tobin index values were measured using a ventilometer. The maximum inspiratory pressure increased significantly (by 7 cm H(2)O, 95% confidence interval [CI] 4-10), and the Tobin index decreased significantly (by 16 breaths/ min/L, 95% CI -26 to 6) in the experimental group compared with the control group. The Chi-squared distribution did not indicate a significant difference in weaning success between the groups (χ(2) = 1.47; P = 0.20). However, a comparison of noninvasive positive pressure time dependence indicated a significantly lower value for the experimental group (P = 0.0001; 95% CI 13.08-18.06). The receiver-operating characteristic curve showed an area beneath the curve of 0.877 ± 0.06 for the Tobin index and 0.845 ± 0.07 for maximum inspiratory pressure. The IMT intervention significantly increased maximum inspiratory pressure and significantly reduced the Tobin index; both measures are considered to be good extubation indices. IMT was associated with a reduction in noninvasive positive

Efficacy of a Social Self-Value Empowerment Intervention to Improve Quality of Life of HIV Infected People Receiving Antiretroviral Treatment in Nepal: A Randomized Controlled Trial.

Science.gov (United States)

Bhatta, Dharma Nand; Liabsuetrakul, Tippawan

2017-06-01

We developed a comprehensive and culturally applicable empowerment intervention social self-value package with an aim to assess its efficacy in order to improve the quality of life (QoL) of HIV infected people receiving antiretroviral treatment. Participants were randomly allocated to receive either six weekly intervention sessions or standard care. Nonlinear mixed-effects models were performed to compare changes in empowerment scores over time. Between September and November 2014, 1447 individuals were screened, of whom 132 were randomly assigned to either the intervention or control group. The mean scores of empowerment, social support and quality of life increased and stigma scores were reduced in the intervention group at 3- and 6-months. An intervention effect on social support, stigma and QoL was significantly increased by time and group with low and high empowerment. No adverse events were reported. The empowerment intervention was efficacious in improving QoL of HIV infected people.

A randomized, controlled study of an educational intervention to improve recall of auxiliary medication labeling and adherence to antibiotics

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Jade A Pham

2013-06-01

Full Text Available Purpose: To evaluate whether medication counseling with emphasis on auxiliary labels improves recall of auxiliary label information and adherence to medication schedules. Methods: A prospective, randomized study of an educational intervention in community pharmacies near Baltimore, Maryland. Fifty literate, English-speaking adults receiving one of the 18 commonly dispensed antibiotics were randomized to receive a counseling session or no counseling. Five to seven days after medication pickup, a structured phone interview was conducted to capture data on recall of auxiliary labels and adherence. Results: A total of 39 subjects completed the phone interview (78%. The rate of correct recall was high: 77% correct recall for all three labels. Among those with incorrect recall, 7 out of 9 subjects received no counseling (p = 0.11. The auxiliary labels incorrectly recalled were all related to dietary restrictions. Conclusion: The findings from this study suggest that medication counseling emphasizing auxiliary label information may lead to improved recall and adherence to antibiotics. Additional studies are required to confirm the preliminary findings and determine whether they correspond to improved adherence. Information most commonly misunderstood were related to dietary restrictions. Additional research focusing on counseling related to dietary restrictions is recommended.

Acute and chronic effects of flavanol-rich cocoa on vascular function in subjects with coronary artery disease: a randomized double-blind placebo-controlled study.

Science.gov (United States)

Farouque, H M Omar; Leung, Michael; Hope, Sarah A; Baldi, Mauro; Schechter, Clyde; Cameron, James D; Meredith, Ian T

2006-07-01

Evidence suggests that flavonoid-containing diets reduce cardiovascular risk, but the mechanisms responsible are unclear. In the present study, we sought to determine the effect of flavanol-rich cocoa on vascular function in individuals with CAD (coronary artery disease). Forty subjects (61+/-8 years; 30 male) with CAD were recruited to a 6-week randomized double-blind placebo-controlled study. Subjects consumed either a flavanol-rich chocolate bar and cocoa beverage daily (total flavanols, 444 mg/day) or matching isocaloric placebos daily (total flavanols, 19.6 mg/day) for 6 weeks. Brachial artery FMD (flow-mediated dilation) and SAC (systemic arterial compliance) were assessed at baseline, 90 min following the first beverage and after 3 and 6 weeks of daily consumption. Soluble cellular adhesion molecules and FBF (forearm blood flow) responses to ACh (acetylcholine chloride; 3-30 microg/min) and SNP (sodium nitroprusside; 0.3-3 microg/min) infusions, forearm ischaemia and isotonic forearm exercise were assessed at baseline and after 6 weeks. FMD, SAC and FBF responses did not differ between groups at baseline. No acute or chronic changes in FMD or SAC were seen in either group. No difference in soluble cellular adhesion molecules, FBF responses to ischaemia, exercise, SNP or ACh was seen in the group receiving flavanol-rich cocoa between baseline and 6 weeks. These data suggest that over a 6-week period, flavanol-rich cocoa does not modify vascular function in patients with established CAD.

Laboratory measures of methylphenidate effects in cocaine-dependent patients receiving treatment.

Science.gov (United States)

Roache, J D; Grabowski, J; Schmitz, J M; Creson, D L; Rhoades, H M

2000-02-01

Two experiments examined the effects of methylphenidate in male and female patients enrolled in an outpatient treatment program for primary cocaine dependence. The first study was a component of a double-blind efficacy trial wherein 57 patients were first tested in a human laboratory for their initial responsiveness to medication. Patients were randomly assigned to receive either placebo or methylphenidate treatment and received their first dose in the human laboratory environment before continuing in outpatient treatment. Methylphenidate was given as a 20-mg sustained-release dose (twice daily) plus an additional 5-mg immediate-release dose combined with the morning dose. Methylphenidate increased heart rate and subjective ratings; however, the subjective effects were primarily of a "dysphoric" nature, and significant effects were limited to increases in anxiety, depression, and anger on the Profile of Mood States; shaky/jittery ratings on a visual analog scale; and dysphoria on the lysergic acid diethylamide (LSD) scale of the Addiction Research Center Inventory. Methylphenidate did not increase cocaine craving nor ratings suggesting abuse potential (i.e., Morphine-Benzedrine Group or drug-liking scores, etc.). None of the drug effects observed in the human laboratory was of clinical concern, and no subject was precluded from continuing in the outpatient study. After outpatient treatment completion, 12 patients were brought back into a second double-blind human laboratory study in which three doses (15, 30, and 60 mg) of immediate-release methylphenidate were administered in an ascending series preceded and followed by placebo. Methylphenidate produced dose-related increases in heart rate, subjective ratings of shaky/jittery, and LSD/dysphoria without significantly altering cocaine craving or stimulant euphoria ratings. These results suggest that stimulant substitution-type approaches to the treatment of cocaine dependence are not necessarily contraindicated

Coleus forskohlii Extract Supplementation in Conjunction with a Hypocaloric Diet Reduces the Risk Factors of Metabolic Syndrome in Overweight and Obese Subjects: A Randomized Controlled Trial

OpenAIRE

Loftus, Hayley L.; Astell, Katie J.; Mathai, Michael L.; Su, Xiao Q.

2015-01-01

Limited studies have shown that Coleus forskohlii extract may aid in weight management. This randomized, double blind placebo-controlled clinical study assessed the effects of supplementation with C. forskohlii extract on key markers of obesity and metabolic parameters in overweight and obese individuals. Thirty participants completed the trial and they were randomly assigned to receive either 250 mg of C. forskohlii extract (n = 15) or a placebo twice daily for 12 weeks. All participants wer...

A randomized, double‑blind clinical study to assess the antiplaque and antigingivitis efficacy of Aloe vera mouth rinse

Directory of Open Access Journals (Sweden)

Bathini Chandrahas

2012-01-01

Full Text Available Aims: To evaluate the efficacy of Aloe Vera mouth rinse on experimental plaque accumulation and gingivitis. Materials and Methods: In this randomized, controlled, and double-blind study, a total of 148 systemically healthy subjects were screened in the age group of 18-25 years. Finally, 120 subjects were requested to abstain from oral hygiene (tooth brushing for 14 days and used a specially fabricated plaque guard. Following cessation of tooth brushing in the specified area, the subjects were randomly divided into Group A (test group who received 100% Aloe vera, Group B (negative control group who received placebo (distilled water, and Group C (positive control group who received 0.2% chlorhexidine. The rinse regimen began on the 15 th day and continued for 7 days. Plaque accumulation was assessed by Plaque Index (PI and gingivitis was assessed by Modified Gingival Index (MGI and Bleeding Index (BI at baseline (0, 7 th , 14 th , and 22 nd days. Results: There was statistically significant decrease in PI, MGI, and BI scores after the rinse regimen began in both Group A (test group and Group C (chlorhexidine compared with Group B. Mouth wash containing Aloe vera showed significant reduction of plaque and gingivitis but when compared with chlorhexidine the effect was less significant. Conclusion: Aloe vera mouthwash can be an effective antiplaque agent and with appropriate refinements in taste and shelf life can be an affordable herbal substitute for chlorhexidine.

Effects of Oxytocin Administration on Receiving Help.

Science.gov (United States)

Human, Lauren J; Woolley, Joshua D; Mendes, Wendy Berry

2017-11-27

Receiving help can be a "mixed blessing." Despite the many psychosocial benefits it can carry, it sometimes has negative psychological consequences, such as loss in self-esteem or enhanced guilt. It is, therefore, important to understand the factors that modify responses to receiving help from others. We explored the role of the hormone oxytocin (OT) on affective and social responses to receiving help, given the putative role of OT in social bonding and attunement. To this end, we manipulated whether help was received from a same-sex interaction partner (confederate) versus a control condition, crossed with a double-blind administration of intranasal OT (vs. placebo), and examined subjective and observer-rated participant responses to help. We observed significant interactions between OT and the help manipulation. In the placebo condition, receiving help from the interaction partner compared with the control condition had negative consequences, such that participants reported greater negative affect and came to view themselves and their interaction partners more negatively after interacting together on several tasks. What is important, however, is that OT administration buffered against these negative subjective responses to receiving help. Further, outside observers rated participants who received OT administration as expressing greater happiness and gratitude in response to help, relative to those who received placebo. In sum, in the context of receiving help from a stranger, oxytocin administration fostered more positive affective and social responses. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Effect of time of administration on cholesterol-lowering by psyllium: a randomized cross-over study in normocholesterolemic or slightly hypercholesterolemic subjects

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Edwards Alun L

2004-09-01

Full Text Available Abstract Background Reports of the use of psyllium, largely in hypercholesterolemic men, have suggested that it lowers serum cholesterol as a result of the binding of bile acids in the intestinal lumen. Widespread advertisements have claimed an association between the use of soluble fibre from psyllium seed husk and a reduced risk of coronary heart disease. Given the purported mechanism of cholesterol-lowering by psyllium, we hypothesized that there would be a greater effect when psyllium is taken with breakfast than when taken at bedtime. Secondarily, we expected to confirm a cholesterol-lowering effect of psyllium in subjects with "average" cholesterol levels. Methods Sixteen men and 47 women ranging in age from 18 to 77 years [mean 53 +/- 13] with LDL cholesterol levels that were normal or slightly elevated but acceptable for subjects at low risk of coronary artery disease were recruited from general gastroenterology and low risk lipid clinics. Following a one month dietary stabilization period, they received an average daily dose of 12.7 g of psyllium hydrophilic mucilloid, in randomized order, for 8 weeks in the morning and 8 weeks in the evening. Change from baseline was determined for serum total cholesterol, LDL, HDL and triglycerides. Results Total cholesterol for the "AM first" group at baseline, 8 and 16 weeks was 5.76, 5.77 and 5.80 mmol/L and for the "PM first" group the corresponding values were 5.47, 5.61 and 5.57 mmol/L. No effect on any lipid parameter was demonstrated for the group as a whole or in any sub-group analysis. Conclusion The timing of psyllium administration had no effect on cholesterol-lowering and, in fact, no cholesterol-lowering was observed. Conclusions regarding the effectiveness of psyllium for the prevention of heart disease in the population at large may be premature.

Random walk of passive tracers among randomly moving obstacles

OpenAIRE

Gori, Matteo; Donato, Irene; Floriani, Elena; Nardecchia, Ilaria; Pettini, Marco

2016-01-01

Background: This study is mainly motivated by the need of understanding how the diffusion behaviour of a biomolecule (or even of a larger object) is affected by other moving macromolecules, organelles, and so on, inside a living cell, whence the possibility of understanding whether or not a randomly walking biomolecule is also subject to a long-range force field driving it to its target. Method: By means of the Continuous Time Random Walk (CTRW) technique the topic of random walk in random en...

Random number generation

International Nuclear Information System (INIS)

Coveyou, R.R.

1974-01-01

The subject of random number generation is currently controversial. Differing opinions on this subject seem to stem from implicit or explicit differences in philosophy; in particular, from differing ideas concerning the role of probability in the real world of physical processes, electronic computers, and Monte Carlo calculations. An attempt is made here to reconcile these views. The role of stochastic ideas in mathematical models is discussed. In illustration of these ideas, a mathematical model of the use of random number generators in Monte Carlo calculations is constructed. This model is used to set up criteria for the comparison and evaluation of random number generators. (U.S.)

In a randomized trial, the live attenuated tetravalent dengue vaccine TV003 is well-tolerated and highly immunogenic in subjects with flavivirus exposure prior to vaccination.

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Stephen S Whitehead

2017-05-01

Full Text Available Infection caused by the four serotypes of dengue virus (DENV-1-4 is a leading cause of mosquito-borne disease. Clinically-severe dengue disease is more common when secondary dengue infection occurs following prior infection with a heterologous dengue serotype. Other flaviviruses such as yellow fever virus, Japanese encephalitis virus, and Zika virus, can also elicit antibodies which are cross-reactive to DENV. As candidate dengue vaccines become available in endemic settings and for individuals who have received other flavivirus vaccines, it is important to examine vaccine safety and immunogenicity in these flavivirus-experienced populations. We performed a randomized, controlled trial of the National Institutes of Health live attenuated tetravalent dengue vaccine candidate (TV003 in fifty-eight individuals with prior exposure to flavivirus infection or vaccine. As in prior studies of this vaccine in flavivirus-naive volunteers, flavivirus-experienced subjects received two doses of vaccine six months apart and were followed closely for clinical events, laboratory changes, viremia, and neutralizing antibody titers. TV003 was well tolerated with few adverse events other than rash, which was predominately mild. Following one dose, 87% of vaccinees had an antibody response to all four serotypes (tetravalent response, suggesting a robust immune response. In addition, 76% of vaccinees were viremic; mean peak titers ranged from 0.68–1.1 log10 PFU/mL and did not differ by serotype. The second dose of TV003 was not associated with viremia, rash, or a sustained boost in antibody titers indicating that a single dose of the vaccine is likely sufficient to prevent viral replication and thus protect against disease. In comparison to the viremia and neutralizing antibody response elicited by TV003 in flavivirus-naïve subjects from prior studies, we found that subjects who were flavivirus-exposed prior to vaccination exhibited slightly higher DENV-3 viremia

Markov counting and reward processes for analysing the performance of a complex system subject to random inspections

International Nuclear Information System (INIS)

Ruiz-Castro, Juan Eloy

2016-01-01

In this paper, a discrete complex reliability system subject to internal failures and external shocks, is modelled algorithmically. Two types of internal failure are considered: repairable and non-repairable. When a repairable failure occurs, the unit goes to corrective repair. In addition, the unit is subject to external shocks that may produce an aggravation of the internal degradation level, cumulative damage or extreme failure. When a damage threshold is reached, the unit must be removed. When a non-repairable failure occurs, the device is replaced by a new, identical one. The internal performance and the external damage are partitioned in performance levels. Random inspections are carried out. When an inspection takes place, the internal performance of the system and the damage caused by external shocks are observed and if necessary the unit is sent to preventive maintenance. If the inspection observes minor state for the internal performance and/or external damage, then these states remain in memory when the unit goes to corrective or preventive maintenance. Transient and stationary analyses are performed. Markov counting and reward processes are developed in computational form to analyse the performance and profitability of the system with and without preventive maintenance. These aspects are implemented computationally with Matlab. - Highlights: • A multi-state device is modelled in an algorithmic and computational form. • The performance is partitioned in multi-states and degradation levels. • Several types of failures with repair times according to degradation levels. • Preventive maintenance as response to random inspection is introduced. • The performance-profitable is analysed through Markov counting and reward processes.

The effects of the Bali Yoga Program (BYP-BC) on reducing psychological symptoms in breast cancer patients receiving chemotherapy: results of a randomized, partially blinded, controlled trial.

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Lanctôt, Dominique; Dupuis, Gilles; Marcaurell, Roger; Anestin, Annélie S; Bali, Madan

2016-12-01

Background Several cognitive behavioral interventions have been reported to reduce psychological symptoms in breast cancer (BC) patients. The goal of this study was to evaluate the effects of a yoga intervention in reducing depression and anxiety symptoms in BC patients. Methods This study was a randomized, partially blinded, controlled trial comparing a standardized yoga intervention to standard care. It was conducted at three medical centers in Montreal, Canada. Eligible patients were women diagnosed with stage I-III BC receiving chemotherapy. Participants were randomly assigned to receive yoga intervention immediately (experimental group, n=58) or after a waiting period (n=43 control group). The Bali Yoga Program for Breast Cancer Patients (BYP-BC) consisted of 23 gentle Hatha asanas (poses), 2 prayanamas (breathing techniques), shavasanas (relaxation corpse poses) and psychoeducational themes. Participants attended eight weekly sessions lasting 90 min each and received a DVD for home practice with 20- and 40-min sessions. Participants in the wait list control group received standard care during the 8-week waiting period. Results A total of 101 participants took part in the final intention-to-treat analyses. The repeated measures analyses demonstrated that depression symptoms increased in the control group (p=0.007), while no change was reported in the BYP-BC group (p=0.29). Also, depression symptoms decreased in the WL control group after receiving the BYP-BC intervention (p=0.03). Finally, there was no statistical significance in terms of anxiety symptoms (p=0.10). Conclusions Results support the BYP-BC intervention as a beneficial means of reducing and preventing the worsening of depression symptoms during chemotherapy treatment.

Shoulder functionality after manual therapy in subjects with shoulder impingement syndrome: a case series.

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Heredia-Rizo, Alberto Marcos; López-Hervás, Antonia; Herrera-Monge, Patricia; Gutiérrez-Leonard, Ana; Piña-Pozo, Fernando

2013-04-01

The aim of the study was to identify the differences in functionality of the upper limb in subjects suffering from shoulder impingement syndrome after intervention by two manual therapy protocols. Randomized, single-blind study with a sample of 22 subjects (58 ± 10.86 years old) divided into two groups. The conventional-group (n = 11) received mobilizations of the shoulder and the experimental-group (n = 11) was treated with soft tissue techniques in the cervical and upper thoracic regions. These two groups received electrotherapy and postural advices. The treatment lasted three weeks (15 daily sessions of 1 h and 30 min). Both active and passive range of motion (ROM) and self-perceived functionality of the upper limb (DASH questionnaire) were measured. The experimental group showed a significant improvement in the DASH scores and both groups improved mobility in the intra-group comparison pre-intervention versus post-intervention (p .05). Our results suggest that a combined treatment with electrotherapy, postural hygiene and manual therapy, regardless of the protocol, improves shoulder mobility and functionality. Copyright © 2012 Elsevier Ltd. All rights reserved.

Shoe Orthotics for the Treatment of Chronic Low Back Pain: A Randomized Controlled Trial.

Science.gov (United States)

Cambron, Jerrilyn A; Dexheimer, Jennifer M; Duarte, Manuel; Freels, Sally

2017-09-01

To investigate the efficacy of shoe orthotics with and without chiropractic treatment for chronic low back pain compared with no treatment. Randomized controlled trial. Integrative medicine teaching clinic at a university. Adult subjects (N=225) with symptomatic low back pain of ≥3 months were recruited from a volunteer sample. Subjects were randomized into 1 of 3 treatment groups (shoe orthotic, plus, and waitlist groups). The shoe orthotic group received custom-made shoe orthotics. The plus group received custom-made orthotics plus chiropractic manipulation, hot or cold packs, and manual soft tissue massage. The waitlist group received no care. The primary outcome measures were change in perceived back pain (numerical pain rating scale) and functional health status (Oswestry Disability Index) after 6 weeks of study participation. Outcomes were also assessed after 12 weeks and then after an additional 3, 6, and 12 months. After 6 weeks, all 3 groups demonstrated significant within-group improvement in average back pain, but only the shoe orthotic and plus groups had significant within-group improvement in function. When compared with the waitlist group, the shoe orthotic group demonstrated significantly greater improvements in pain (Ppain (P=.3431). Group differences at 12 weeks and later were not significant. Six weeks of prescription shoe orthotics significantly improved back pain and dysfunction compared with no treatment. The addition of chiropractic care led to higher improvements in function. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Results of a prospective randomized controlled trial of early ambulation for patients with lower extremity autografts.

Science.gov (United States)

Lorello, David John; Peck, Michael; Albrecht, Marlene; Richey, Karen J; Pressman, Melissa A

2014-01-01

It is common practice to keep those patients with lower extremity autografts immobile until post-operative day (POD) 5. There is however inherent risks associated with even short periods of immobility. As of now there are no randomized controlled trials looking at early ambulation of patients with lower extremity autografts in the burn community.The objective of this study was to show that patients who begin ambulation within 24 hours of lower extremity autografting will have no increased risk of graft failure than those patients who remain immobile until POD 5. Thirty-one subjects who received autografts to the lower extremity were randomized after surgery into either the early ambulation group (EAG;17 subjects) or the standard treatment group (STG;14 subjects). Those subjects randomized to the EAG began ambulating with physical therapy on POD 1. Subjects in the STG maintained bed rest until POD 5. There was no difference in the number of patients with graft loss in either the EAG or STG on POD 5, and during any of the follow-up visits. No subjects required regrafting. There was a significant difference in the mean minutes of ambulation, with the EAG ambulating longer than the STG (EAG 23.4 minutes [SD 12.03], STG 14.1 [SD 9.00], P=.0235) on POD 5. Burn patients with lower extremity autografts can safely ambulate on POD 1 without fear of graft failure compared with those patients that remain on bed rest for 5 days.

Efficacy and Safety of IncobotulinumtoxinA in Subjects Previously Treated with Botulinum Toxin versus Toxin-Naïve Subjects with Cervical Dystonia

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Hubert Fernandez

2013-05-01

Full Text Available Background: To determine whether botulinum toxin treatment history affected the outcomes of a study comparing the safety and efficacy of incobotulinumtoxinA with placebo in subjects with cervical dystonia (CD.Methods: This was a prospective, double‐blind, randomized, placebo‐controlled, multicenter trial in botulinum toxin‐treated or toxin‐naïve CD subjects. Subjects received a fixed dose of either 120 U or 240 U of incobotulinumtoxinA or placebo. The primary outcome measure was change from baseline to Week 4 in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS total score. Treatment‐emergent adverse events (TEAEs were also evaluated. This report represents a subgroup analysis of botulinum toxin‐treated or toxin‐naïve subjects.Results: Participants (N = 233; 38.6% toxin‐naïve had a mean age of 52.8 years. IncobotulinumtoxinA significantly improved TWSTRS total scores from baseline to Week 4 in both dose groups versus placebo, and the improvement persisted through the end of the study (≤20 weeks. Both the previously toxin‐treated and toxin‐naïve subjects demonstrated significant improvements in TWSTRS total scores at Week 4 compared to baseline. The most frequent TEAEs in the incobotulinumtoxinA groups were dysphagia, neck pain, and muscular weakness, which were generally mild. TEAEs were more common in the 240 U group and toxin‐naïve subjects. Discussion: Overall, incobotulinumtoxinA was safe and effective in CD, regardless of toxin therapy history. A lower starting dose may be better tolerated among toxin‐naïve subjects without sacrificing efficacy.

A Walnut-Enriched Diet Reduces Lipids in Healthy Caucasian Subjects, Independent of Recommended Macronutrient Replacement and Time Point of Consumption: a Prospective, Randomized, Controlled Trial.

Science.gov (United States)

Bamberger, Charlotte; Rossmeier, Andreas; Lechner, Katharina; Wu, Liya; Waldmann, Elisa; Stark, Renée G; Altenhofer, Julia; Henze, Kerstin; Parhofer, Klaus G

2017-10-06

Studies indicate a positive association between walnut intake and improvements in plasma lipids. We evaluated the effect of an isocaloric replacement of macronutrients with walnuts and the time point of consumption on plasma lipids. We included 194 healthy subjects (134 females, age 63 ± 7 years, BMI 25.1 ± 4.0 kg/m²) in a randomized, controlled, prospective, cross-over study. Following a nut-free run-in period, subjects were randomized to two diet phases (8 weeks each). Ninety-six subjects first followed a walnut-enriched diet (43 g walnuts/day) and then switched to a nut-free diet. Ninety-eight subjects followed the diets in reverse order. Subjects were also randomized to either reduce carbohydrates ( n = 62), fat ( n = 65), or both ( n = 67) during the walnut diet, and instructed to consume walnuts either as a meal or as a snack. The walnut diet resulted in a significant reduction in fasting cholesterol (walnut vs. -8.5 ± 37.2 vs. -1.1 ± 35.4 mg/dL; p = 0.002), non-HDL cholesterol (-10.3 ± 35.5 vs. -1.4 ± 33.1 mg/dL; p ≤ 0.001), LDL-cholesterol (-7.4 ± 32.4 vs. -1.7 ± 29.7 mg/dL; p = 0.029), triglycerides (-5.0 ± 47.5 vs. 3.7 ± 48.5 mg/dL; p = 0.015) and apoB (-6.7 ± 22.4 vs. -0.5 ± 37.7; p ≤ 0.001), while HDL-cholesterol and lipoprotein (a) did not change significantly. Neither macronutrient replacement nor time point of consumption significantly affected the effect of walnuts on lipids. Thus, 43 g walnuts/d improved the lipid profile independent of the recommended macronutrient replacement and the time point of consumption.

A randomized controlled trial of nasolaryngoscopy training techniques.

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Smith, Matthew E; Leung, Billy C; Sharma, Rishi; Nazeer, Sammar; McFerran, Don J

2014-09-01

Flexible nasolaryngoscopy is an essential skill for otolaryngology trainees to develop, but there is a lack of standardized training for this procedure. The aim of this study was to assess whether using training on a realistic human mannequin together with structured video feedback improved trainees' performance at flexible nasolaryngoscopy. Three-armed, single-blinded, randomized controlled study. Thirty-six junior doctors and final-year medical students were randomly allocated to one of three groups. All received a lecture and video presentation on flexible nasolaryngoscopy. One group received additional tuition using a training mannequin. The last group received mannequin training and feedback on their performance using a video recording. The trainees then undertook flexible nasolaryngoscopy on volunteers with these endoscopies recorded. Blinded observers scored the trainees on a range of objective and subjective measures. The volunteers who were also blinded to the candidates' training scored the comfort of the procedure. Adding mannequin training showed a trend toward improvement of performance but did not reach statistical significance. Mannequin training together with video feedback produced significant performance improvement in patient comfort (P = .0065), time to reach the vocal folds (P = .017), and global ability (P = .0006). Inter-rater reliability was excellent with P training using an anatomically correct model of the upper airway together with formalized video-assisted feedback on that training is a simple and effective way to improve endoscopy skills prior to starting flexible nasolaryngoscopy on patients. © 2014 The American Laryngological, Rhinological and Otological Society, Inc.

Piezoelectric energy harvesting from broadband random vibrations

International Nuclear Information System (INIS)

Adhikari, S; Friswell, M I; Inman, D J

2009-01-01

Energy harvesting for the purpose of powering low power electronic sensor systems has received explosive attention in the last few years. Most works using deterministic approaches focusing on using the piezoelectric effect to harvest ambient vibration energy have concentrated on cantilever beams at resonance using harmonic excitation. Here, using a stochastic approach, we focus on using a stack configuration and harvesting broadband vibration energy, a more practically available ambient source. It is assumed that the ambient base excitation is stationary Gaussian white noise, which has a constant power-spectral density across the frequency range considered. The mean power acquired from a piezoelectric vibration-based energy harvester subjected to random base excitation is derived using the theory of random vibrations. Two cases, namely the harvesting circuit with and without an inductor, have been considered. Exact closed-form expressions involving non-dimensional parameters of the electromechanical system have been given and illustrated using numerical examples

Piezoelectric energy harvesting from broadband random vibrations

Science.gov (United States)

Adhikari, S.; Friswell, M. I.; Inman, D. J.

2009-11-01

Energy harvesting for the purpose of powering low power electronic sensor systems has received explosive attention in the last few years. Most works using deterministic approaches focusing on using the piezoelectric effect to harvest ambient vibration energy have concentrated on cantilever beams at resonance using harmonic excitation. Here, using a stochastic approach, we focus on using a stack configuration and harvesting broadband vibration energy, a more practically available ambient source. It is assumed that the ambient base excitation is stationary Gaussian white noise, which has a constant power-spectral density across the frequency range considered. The mean power acquired from a piezoelectric vibration-based energy harvester subjected to random base excitation is derived using the theory of random vibrations. Two cases, namely the harvesting circuit with and without an inductor, have been considered. Exact closed-form expressions involving non-dimensional parameters of the electromechanical system have been given and illustrated using numerical examples.

The Relieving Effects of BrainPower Advanced, a Dietary Supplement, in Older Adults with Subjective Memory Complaints: A Randomized, Double-Blind, Placebo-Controlled Trial

OpenAIRE

Zhu, Jingfen; Shi, Rong; Chen, Su; Dai, Lihua; Shen, Tian; Feng, Yi; Gu, Pingping; Shariff, Mina; Nguyen, Tuong; Ye, Yeats; Rao, Jianyu; Xing, Guoqiang

2016-01-01

Subjective memory complaints (SMCs) are common in older adults that can often predict further cognitive impairment. No proven effective agents are available for SMCs. The effect of BrainPower Advanced, a dietary supplement consisting of herbal extracts, nutrients, and vitamins, was evaluated in 98 volunteers with SMCs, averaging 67 years of age (47?88), in a randomized, double-blind, placebo-controlled trial. Subjective hypomnesis/memory loss (SML) and attention/concentration deficits (SAD) w...

Introducing taxes, subsidies or both: the effects of various food pricing strategies in a web-based supermarket randomized trial.

Science.gov (United States)

Waterlander, Wilma E; Steenhuis, Ingrid H M; de Boer, Michiel R; Schuit, Albertine J; Seidell, Jacob C

2012-05-01

Fiscal policies may form a solution in improving dietary intake. This study aimed to examine the effectiveness of varying taxing and subsiding schemes to stimulate healthier food purchases. A randomized controlled trial with three levels of price reduction on healthy foods (no; 25%; 50%)×three levels of price increase on unhealthy foods (5%; 10%; 25%) factorial design was used. 150 participants were randomized into one of nine conditions and were asked to purchase groceries at a web-based supermarket. Data were collected in the Netherlands in January-February 2010 and analyzed using analysis of covariance. Subjects receiving 50% discount purchased significantly more healthy foods than subjects receiving no (mean difference=6.62 items, pprice increases on unhealthy foods were found. Price decreases are effective in stimulating healthy food purchases, but the proportion of healthy foods remains unaffected. Price increases up to 25% on unhealthier products do not significantly affect food purchases. Future studies are important to validate these results in real supermarkets and across different countries. Copyright © 2012 Elsevier Inc. All rights reserved.

Effects of formulation on the bioavailability of lutein and zeaxanthin: a randomized, double-blind, cross-over, comparative, single-dose study in healthy subjects.

Science.gov (United States)

Evans, Malkanthi; Beck, Mareike; Elliott, James; Etheve, Stephane; Roberts, Richard; Schalch, Wolfgang

2013-06-01

Lutein and zeaxanthin are macular pigments with a protective function in the retina. These xanthophylls must be obtained from the diet or added to foods or supplements via easy-to-use, stable formulations. The technique employed to produce these formulations may affect the bioavailability of the xanthophylls. Forty-eight healthy volunteers were randomized into this double-blind, cross-over study investigating the plasma kinetics of lutein provided as two different beadlet formulations. Subjects (n = 48) received a single dose of 20 mg of lutein as either a starch-matrix ("SMB", FloraGLO® Lutein 5 %) or as a cross-linked alginate-matrix beadlet ("AMB", Lyc-O-Lutein 20 %) formulation. Plasma concentrations of lutein and zeaxanthin were measured at 0, 1, 3, 6, 9, 12, 14, 24, 26, 28, 32, 36, 48, 72, 168, and 672 h. The mean plasma AUC(0-72h), AUC(0-672h), and C(max) for total lutein and zeaxanthin and their all-E-isomers were significantly increased (p < 0.001) from pre-dose concentrations in response to SMB and AMB. There was no difference in lutein T max between the two test articles. However, by 14 h post-dose, total plasma lutein increased by 7 % with AMB and by 126 % with SMB. Total lutein AUC(0-72h) and AUC(0-672h) were 1.8-fold and 1.3-fold higher, respectively, for SMB compared to AMB. Both formulations were well tolerated by subjects in this study. These findings confirm that the bioavailability of lutein and zeaxanthin critically depends on the formulation used and document a superiority of the starch-based over the alginate-based product in this study.

Rapid, easy, and cheap randomization: prospective evaluation in a study cohort

Directory of Open Access Journals (Sweden)

Parker Melissa J

2012-06-01

Full Text Available Abstract Background When planning a randomized controlled trial (RCT, investigators must select randomization and allocation procedures based upon a variety of factors. While third party randomization is cited as being among the most desirable randomization processes, many third party randomization procedures are neither feasible nor cost-effective for small RCTs, including pilot RCTs. In this study we present our experience with a third party randomization and allocation procedure that utilizes current technology to achieve randomization in a rapid, reliable, and cost-effective manner. Methods This method was developed by the investigators for use in a small 48-participant parallel group RCT with four study arms. As a nested study, the reliability of this randomization procedure was prospectively evaluated in this cohort. The primary outcome of this nested study was the proportion of subjects for whom allocation information was obtained by the Research Assistant within 15 min of the initial participant randomization request. A secondary outcome was the average time for communicating participant group assignment back to the Research Assistant. Descriptive information regarding any failed attempts at participant randomization as well as costs attributable to use of this method were also recorded. Statistical analyses included the calculation of simple proportions and descriptive statistics. Results Forty-eight participants were successfully randomized and group allocation instruction was received for 46 (96% within 15 min of the Research Assistant placing the initial randomization request. Time elapsed in minutes until receipt of participant allocation instruction was Mean (SD 3.1 +/− 3.6; Median (IQR 2 (2,3; Range (1–20 for the entire cohort of 48. For the two participants for whom group allocation information was not received by the Research Assistant within the 15-min pass threshold, this information was obtained following a second

Effect of Etelcalcetide vs Placebo on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: Two Randomized Clinical Trials.

Science.gov (United States)

Block, Geoffrey A; Bushinsky, David A; Cunningham, John; Drueke, Tilman B; Ketteler, Markus; Kewalramani, Reshma; Martin, Kevin J; Mix, T Christian; Moe, Sharon M; Patel, Uptal D; Silver, Justin; Spiegel, David M; Sterling, Lulu; Walsh, Liron; Chertow, Glenn M

2017-01-10

Secondary hyperparathyroidism contributes to extraskeletal complications in chronic kidney disease. To evaluate the effect of the intravenous calcimimetic etelcalcetide on serum parathyroid hormone (PTH) concentrations in patients receiving hemodialysis. Two parallel, phase 3, randomized, placebo-controlled treatment trials were conducted in 1023 patients receiving hemodialysis with moderate to severe secondary hyperparathyroidism. Trial A was conducted in 508 patients at 111 sites in the United States, Canada, Europe, Israel, Russia, and Australia from March 12, 2013, to June 12, 2014; trial B was conducted in 515 patients at 97 sites in the same countries from March 12, 2013, to May 12, 2014. Intravenous administration of etelcalcetide (n = 503) or placebo (n = 513) after each hemodialysis session for 26 weeks. The primary efficacy end point was the proportion of patients achieving greater than 30% reduction from baseline in mean PTH during weeks 20-27. A secondary efficacy end point was the proportion of patients achieving mean PTH of 300 pg/mL or lower. The mean age of the 1023 patients was 58.2 (SD, 14.4) years and 60.4% were men. Mean PTH concentrations at baseline and during weeks 20-27 were 849 and 384 pg/mL vs 820 and 897 pg/mL in the etelcalcetide and placebo groups, respectively, in trial A; corresponding values were 845 and 363 pg/mL vs 852 and 960 pg/mL in trial B. Patients randomized to etelcalcetide were significantly more likely to achieve the primary efficacy end point: in trial A, 188 of 254 (74.0%) vs 21 of 254 (8.3%; P secondary hyperparathyroidism, use of etelcalcetide compared with placebo resulted in greater reduction in serum PTH over 26 weeks. Further studies are needed to assess clinical outcomes as well as longer-term efficacy and safety. clinicaltrials.gov Identifiers: NCT01788046.

The safety and efficacy of {+/-}3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study.

Science.gov (United States)

Mithoefer, Michael C; Wagner, Mark T; Mithoefer, Ann T; Jerome, Lisa; Doblin, Rick

2011-04-01

Case reports indicate that psychiatrists administered ±3,4-methylenedioxymethamphetamine (MDMA) as a catalyst to psychotherapy before recreational use of MDMA as 'Ecstasy' resulted in its criminalization in 1985. Over two decades later, this study is the first completed clinical trial evaluating MDMA as a therapeutic adjunct. Twenty patients with chronic posttraumatic stress disorder, refractory to both psychotherapy and psychopharmacology, were randomly assigned to psychotherapy with concomitant active drug (n = 12) or inactive placebo (n = 8) administered during two 8-h experimental psychotherapy sessions. Both groups received preparatory and follow-up non-drug psychotherapy. The primary outcome measure was the Clinician-Administered PTSD Scale, administered at baseline, 4 days after each experimental session, and 2 months after the second session. Neurocognitive testing, blood pressure, and temperature monitoring were performed. After 2-month follow-up, placebo subjects were offered the option to re-enroll in the experimental procedure with open-label MDMA. Decrease in Clinician-Administered PTSD Scale scores from baseline was significantly greater for the group that received MDMA than for the placebo group at all three time points after baseline. The rate of clinical response was 10/12 (83%) in the active treatment group versus 2/8 (25%) in the placebo group. There were no drug-related serious adverse events, adverse neurocognitive effects or clinically significant blood pressure increases. MDMA-assisted psychotherapy can be administered to posttraumatic stress disorder patients without evidence of harm, and it may be useful in patients refractory to other treatments.

Efficacy of Arthroscopic Teaching Methods: A Prospective Randomized Controlled Study.

Science.gov (United States)

Robinson, Luke; Spanyer, Jonathon; Yenna, Zachary; Burchell, Patrick; Garber, Andrew; Riehl, John

Arthroscopic education research recently has been focused on the use of skills labs to facilitate resident education and objective measure development to gauge technical skill. This study evaluates the effectiveness of three different teaching methods. Medical students were randomized into three groups. The first group received only classroom-based lecture. The second group received the same lecture and 28 minutes of lab-based hands-off arthroscopy instruction using a cadaver and arthroscopy setup. The final group received the same lecture and 7 minutes of hands-on arthroscopy instruction in the lab on a cadaver knee. The arthroscopic knee exam that followed simulated a diagnostic knee exam and subjects were measured on task completion and by the number of look downs. The number of look downs and the number of tasks completed did not achieve statistical significance between groups. Posttest survey results revealed that the hands-on group placed significantly more value on their educational experience as compared with the other two groups. (Journal of Surgical Orthopaedic Advances.

Comparison of Stimdate with Ritalin in Children and Adolescents with Attention Deficit Hyperactivity Disorder: a Double-Blind, Randomized Clinical Trial

Directory of Open Access Journals (Sweden)

Najmeh Khosrovan Mehr

2009-02-01

Full Text Available "nObjectives: The aim of this randomized clinical trial was to assess the efficacy of stimdate compared to ritalin in the treatment of children with attention deficit hyperactivity disorder (ADHD. "nMethod: Sixty four subjects (45 boys and 15 girls aged 5-13 who were diagnosed with ADHD based on (DSM-IV-TR criteria were selected for this study. The subjects were randomly assigned to two groups: one group with 30 subjects received stimdate and the other group of 30 subjects received ritalin for 6 weeks. Treatment outcomes were assessed using the Attention Deficit Hyperactivity Rating Scale administered at baseline and on weeks 2, 4 and 6 following the treatment. A two-way repeated measures analysis of variance (time- treatment interaction was used. "nResults: There were no significant differences between sex, age, weight, and ethnicity of the participants in the 2 groups. Both groups showed a significant improvement during the 6 weeks of the treatment period, and this improvement was due to the parents' ADHD Rating Scale during the treatment. "nConclusion: Based on the results of this study, no significant difference was observed between the two medications, and it seems both drugs behave[M1]  in a similar way. In addition, stimdate appears to be effective and well tolerated for ADHD in children and adolescents in Iran. "n 

Approximate Forward Difference Equations for the Lower Order Non-Stationary Statistics of Geometrically Non-Linear Systems subject to Random Excitation

DEFF Research Database (Denmark)

Köylüoglu, H. U.; Nielsen, Søren R. K.; Cakmak, A. S.

Geometrically non-linear multi-degree-of-freedom (MDOF) systems subject to random excitation are considered. New semi-analytical approximate forward difference equations for the lower order non-stationary statistical moments of the response are derived from the stochastic differential equations...... of motion, and, the accuracy of these equations is numerically investigated. For stationary excitations, the proposed method computes the stationary statistical moments of the response from the solution of non-linear algebraic equations....

Subcutaneously administered Menopur(R, a new highly purified human menopausal gonadotropin, causes significantly fewer injection site reactions than Repronex(R in subjects undergoing in vitro fertilization

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Somkuti Stephen

2005-11-01

Full Text Available Abstract Background The safety and tolerability of a new highly purified, urine-derived human menopausal gonadotropin (hMG preparation [Menopur(R] was compared with a currently available hMG [Repronex (R] in women undergoing in vitro fertilization (IVF. Methods This was a randomized, open-label, parallel-group, multicenter study conducted in subjects undergoing IVF. Women (N = 125, 18–39 years of age, underwent pituitary down-regulation with leuprolide acetate beginning 7 days prior to onset of menses and continuing up to the day before hCG administration. Subjects were randomized to receive subcutaneous (SC Menopur (R (n = 61 or Repronex (R SC (n = 64 for a maximum of 12 days. All adverse events (AEs were recorded and subject self-assessments of injection site reactions were recorded in a daily diary. Results Significantly fewer subjects in the Menopur (R group reported injection site reactions (P Conclusion Menopur (R SC offers a greater safety and tolerability profile compared to Repronex (R SC.

Autoshaping, random control, and omission training in the rat.

Science.gov (United States)

Locurto, C; Terrace, H S; Gibbon, J

1976-11-01

The role of the stimulus-reinforcer contingency in the development and maintenance of lever contact responding was studied in hooded rats. In Experiment I, three groups of experimentally naive rats were trained either on autoshaping, omission training, or a random-control procedure. Subjects trained by the autoshaping procedure responded more consistently than did either random-control or omission-trained subjects. The probability of at least one lever contact per trial was slightly higher in subjects trained by the omission procedure than by the random-control procedure. However, these differences were not maintained during extended training, nor were they evident in total lever-contact frequencies. When omission and random-control subjects were switched to the autoshaping condition, lever contacts increased in all animals, but a pronounced retardation was observed in omission subjects relative to the random-control subjects. In addition, subjects originally exposed to the random-control procedure, and later switched to autoshaping, acquired more rapidly than naive subjects that were exposed only on the autoshaping procedure. In Experiment II, subjects originally trained by an autoshaping procedure were exposed either to an omission, a random-control, or an extinction procedure. No differences were observed among the groups either in the rate at which lever contacts decreased or in the frequency of lever contacts at the end of training. These data implicate prior experience in the interpretation of omission-training effects and suggest limitations in the influence of stimulus-reinforcer relations in autoshaping.

Predictors of suicidal ideation in older individuals receiving home-care services.

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Park, Jong-Il; Han, Myeong-Il; Kim, Myung Sig; Yoon, Myeong-Sook; Ko, Sung-Hee; Cho, Hye-Chung; Chung, Young-Chul

2014-04-01

Despite the importance of tending to older individuals who are vulnerable to suicide, little is known about suicidal ideation in the portion of this population receiving home-care services in Asian countries. The objective of this cross-sectional study was to examine predictors of suicidal ideation in older individuals using home-care service. Participants were randomly selected from the individuals 50 years old and over using home-care services across Jeollabuk-do Province, Korea. A total of 697 subjects participated in this study. Each participant completed the short version of the Geriatric Depression Scale, the Scale for Suicidal Ideation, the Multidimensional Scale of Perceived Social Support, and the World Health Organization Disability Assessment Schedule II. Hierarchical regression analyses revealed that depression, perceived social support, and disability were significant predictors of suicidal ideation, whereas the roles of subjective health status and fish consumption remained ambiguous in this regard. In terms of social support, we also found that less perceived social support from family members was related to higher levels of suicidal ideation. The associations between various categories of disability and suicidal ideation disappeared after controlling for depression. Our investigation of the mediating effect of depression on the relationship between disability and suicidal ideation revealed that depression was either a complete (disability related to cognition, self-care, getting along with others, and life activities) or partial (disability related to participation) mediator. Preventive strategies focusing on depression, social support, and disability should be emphasized during encounters with older people receiving home-care services. Copyright © 2013 John Wiley & Sons, Ltd.

The short-term safety and efficacy of fluoxetine in depressed adolescents with alcohol and cannabis use disorders: a pilot randomized placebo-controlled trial

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Lingler Jacqui

2009-03-01

Full Text Available Abstract Background The objective of this study was to examine whether fluoxetine was superior to placebo in the acute amelioration of depressive symptomatology in adolescents with depressive illness and a comorbid substance use disorder. Methods Eligible subjects ages 12–17 years with either a current major depressive disorder (MDD or a depressive disorder that were also suffering from a comorbid substance-related disorder were randomized to receive either fluoxetine or placebo in this single site, 8-week double-blind, placebo-controlled study. The primary outcome analysis was a random effects mixed model for repeated measurements of Children's Depression Rating Scale-Revised (CDRS-R scores compared between treatment groups across time. Results An interim analysis was performed after 34 patients were randomized. Based on the results of a futility analysis, study enrollment was halted. Twenty-nine males and 5 females were randomized to receive fluoxetine (n = 18 or placebo (n = 16. Their mean age was 16.5 (1.1 years. Overall, patients who received fluoxetine and placebo had a reduction in CDRS-R scores. However, there was no significant difference in mean change in CDRS-R total score in those subjects treated with fluoxetine and those who received placebo (treatment difference = 0.19, S.E. = 0.58, F = 0.14, p = .74. Furthermore, there was not a significant difference in rates of positive urine drug toxicology results between treatment groups at any post-randomization visit (F = 0.22, df = 1, p = 0.65. The main limitation of this study is its modest sample size and resulting low statistical power. Other significant limitations to this study include, but are not limited to, the brevity of the trial, high placebo response rate, limited dose range of fluoxetine, and the inclusion of youth who met criteria for depressive disorders other than MDD. Conclusion Fluoxetine was not superior to placebo in alleviating depressive symptoms or in decreasing

Extubation process in bed-ridden elderly intensive care patients receiving inspiratory muscle training: a randomized clinical trial

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Cader SA

2012-10-01

Full Text Available Samária Ali Cader,1 Rodrigo Gomes de Souza Vale,1 Victor Emmanuel Zamora,2 Claudia Henrique Costa,2 Estélio Henrique Martin Dantas11Laboratory of Human Kinetics Bioscience, Federal University of Rio de Janeiro State, 2Pedro Ernesto University Hospital, School of Medicine, State University of Rio de Janeiro, Rio de Janeiro, BrazilBackground: The purpose of this study was to evaluate the extubation process in bed-ridden elderly intensive care patients receiving inspiratory muscle training (IMT and identify predictors of successful weaning.Methods: Twenty-eight elderly intubated patients in an intensive care unit were randomly assigned to an experimental group (n = 14 that received conventional physiotherapy plus IMT with a Threshold IMT® device or to a control group (n = 14 that received only conventional physiotherapy. The experimental protocol for muscle training consisted of an initial load of 30% maximum inspiratory pressure, which was increased by 10% daily. The training was administered for 5 minutes, twice daily, 7 days a week, with supplemental oxygen from the beginning of weaning until extubation. Successful extubation was defined by the ventilation time measurement with noninvasive positive pressure. A vacuum manometer was used for measurement of maximum inspiratory pressure, and the patients' Tobin index values were measured using a ventilometer.Results: The maximum inspiratory pressure increased significantly (by 7 cm H2O, 95% confidence interval [CI] 4–10, and the Tobin index decreased significantly (by 16 breaths/min/L, 95% CI −26 to 6 in the experimental group compared with the control group. The Chi-squared distribution did not indicate a significant difference in weaning success between the groups (Χ2 = 1.47; P = 0.20. However, a comparison of noninvasive positive pressure time dependence indicated a significantly lower value for the experimental group (P = 0.0001; 95% CI 13.08–18.06. The receiver

Effects of aerobic and resistance exercise in breast cancer patients receiving adjuvant chemotherapy: a multicenter randomized controlled trial.

Science.gov (United States)

Courneya, Kerry S; Segal, Roanne J; Mackey, John R; Gelmon, Karen; Reid, Robert D; Friedenreich, Christine M; Ladha, Aliya B; Proulx, Caroline; Vallance, Jeffrey K H; Lane, Kirstin; Yasui, Yutaka; McKenzie, Donald C

2007-10-01

Breast cancer chemotherapy may cause unfavorable changes in physical functioning, body composition, psychosocial functioning, and quality of life (QOL). We evaluated the relative merits of aerobic and resistance exercise in blunting these effects. We conducted a multicenter randomized controlled trial in Canada between 2003 and 2005 that randomly assigned 242 breast cancer patients initiating adjuvant chemotherapy to usual care (n = 82), supervised resistance exercise (n = 82), or supervised aerobic exercise (n = 78) for the duration of their chemotherapy (median, 17 weeks; 95% CI, 9 to 24 weeks). Our primary end point was cancer-specific QOL assessed by the Functional Assessment of Cancer Therapy-Anemia scale. Secondary end points were fatigue, psychosocial functioning, physical fitness, body composition, chemotherapy completion rate, and lymphedema. The follow-up assessment rate for our primary end point was 92.1%, and adherence to the supervised exercise was 70.2%. Unadjusted and adjusted mixed-model analyses indicated that aerobic exercise was superior to usual care for improving self-esteem (P = .015), aerobic fitness (P = .006), and percent body fat (adjusted P = .076). Resistance exercise was superior to usual care for improving self-esteem (P = .018), muscular strength (P exercise groups but did not reach statistical significance. Exercise did not cause lymphedema or adverse events. Neither aerobic nor resistance exercise significantly improved cancer-specific QOL in breast cancer patients receiving chemotherapy, but they did improve self-esteem, physical fitness, body composition, and chemotherapy completion rate without causing lymphedema or significant adverse events.

Performance of a nonlinear receiver for the ultrashort-pulse optical CDMA system

Science.gov (United States)

Ni, Bin; Lehnert, James S.

2005-09-01

At the receiver of an ultrashort-pulse optical code-division multiple-access (OCDMA) system, a nonlinear thresholder is needed to discriminate between the correctly decoded short pulse and the interference that appears to be a pseudorandom signal. It has been demonstrated that the self phase modulation (SPM) effect can be used to realize this nonlinear thresholder. The performance of a system that exploits this phenomenon is analyzed in this paper. If the spreading code is random, the electrical field of the interfering signal from the multiple users can be shown to be a complex Gaussian random process. The broadened power spectral density (PSD) function caused by the SPM effect can be calculated. When "1" is transmitted, the correctly decoded signal from the desired user, which is a deterministic waveform, is added to the Gaussian random process. Beating between the two signals causes random fluctuations in the power. Since the strength of the SPM effect is proportional to the variation rate of power, the broadened signal spectrum will appear random. The Monte Carlo method is used to obtain the properties of the decision statistic. Finally, the bit-error rate (BER) is calculated, and the simulation results are presented. The result reveals that the performance of the SPM-based nonlinear receiver can outperform the ideal linear receiver in some circumstances.

The safety and efficacy of ±3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study

Science.gov (United States)

Mithoefer, Michael C; Wagner, Mark T; Mithoefer, Ann T; Jerome, Lisa; Doblin, Rick

2011-01-01

Case reports indicate that psychiatrists administered ±3,4-methylenedioxymethamphetamine (MDMA) as a catalyst to psychotherapy before recreational use of MDMA as ‘Ecstasy’ resulted in its criminalization in 1985. Over two decades later, this study is the first completed clinical trial evaluating MDMA as a therapeutic adjunct. Twenty patients with chronic posttraumatic stress disorder, refractory to both psychotherapy and psychopharmacology, were randomly assigned to psychotherapy with concomitant active drug (n = 12) or inactive placebo (n = 8) administered during two 8-h experimental psychotherapy sessions. Both groups received preparatory and follow-up non-drug psychotherapy. The primary outcome measure was the Clinician-Administered PTSD Scale, administered at baseline, 4 days after each experimental session, and 2 months after the second session. Neurocognitive testing, blood pressure, and temperature monitoring were performed. After 2-month follow-up, placebo subjects were offered the option to re-enroll in the experimental procedure with open-label MDMA. Decrease in Clinician-Administered PTSD Scale scores from baseline was significantly greater for the group that received MDMA than for the placebo group at all three time points after baseline. The rate of clinical response was 10/12 (83%) in the active treatment group versus 2/8 (25%) in the placebo group. There were no drug-related serious adverse events, adverse neurocognitive effects or clinically significant blood pressure increases. MDMA-assisted psychotherapy can be administered to posttraumatic stress disorder patients without evidence of harm, and it may be useful in patients refractory to other treatments. PMID:20643699

Efficacy and safety of almorexant in adult chronic insomnia: a randomized placebo-controlled trial with an active reference.

Science.gov (United States)

Black, Jed; Pillar, Giora; Hedner, Jan; Polo, Olli; Berkani, Ouali; Mangialaio, Sara; Hmissi, Abdel; Zammit, Gary; Hajak, Goran

2017-08-01

The orally active dual OX 1 R and OX 2 R antagonist, almorexant, targets the orexin system for the treatment of primary insomnia. This clinical trial assessed the effect of almorexant on sleep maintenance and other sleep endpoints, and its safety and tolerability in adults. Prospective, randomized, double-blind, placebo-controlled, active referenced trial in male and female adults aged 18-64 years with chronic, primary insomnia. Patients were randomized 1:1:1:1 to receive placebo, almorexant 100 mg, almorexant 200 mg, or zolpidem 10 mg (active reference) for 16 days. Primary efficacy assessments were objective (polysomnography-measured) and subjective (patient-recorded) wake time after sleep onset (WASO). Further sleep variables were also evaluated. From 709 randomized patients, 707 (mean age 45.4 years; 61.7% female) received treatment and 663 (93.8%) completed the study. A significant decrease versus placebo in median objective WASO was observed with almorexant 200 mg at the start and end of randomized treatment (-26.8 min and -19.5 min, respectively; both p system in insomnia disorder. CLINICALTRIALS. NCT00608985. Copyright © 2017 Elsevier B.V. All rights reserved.

Disclosure of Personalized Rheumatoid Arthritis Risk Using Genetics, Biomarkers, and Lifestyle Factors to Motivate Health Behavior Improvements: A Randomized Controlled Trial.

Science.gov (United States)

Sparks, Jeffrey A; Iversen, Maura D; Yu, Zhi; Triedman, Nellie A; Prado, Maria G; Miller Kroouze, Rachel; Kalia, Sarah S; Atkinson, Michael L; Mody, Elinor A; Helfgott, Simon M; Todd, Derrick J; Dellaripa, Paul F; Bermas, Bonnie L; Costenbader, Karen H; Deane, Kevin D; Lu, Bing; Green, Robert C; Karlson, Elizabeth W

2017-10-12

To determine the effect of disclosure of rheumatoid arthritis (RA) risk personalized with genetics, biomarkers, and lifestyle factors on health behavior intentions. We performed a randomized controlled trial among first-degree relatives without RA. Subjects assigned to the Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) group received the web-based PRE-RA tool for RA risk factor education and disclosure of personalized RA risk estimates, including genotype/autoantibody results and behaviors (n = 158). Subjects assigned to the comparison arm received standard RA education (n = 80). The primary outcome was readiness for change based on the trans-theoretical model, using validated contemplation ladder scales. Increased motivation to improve RA risk-related behaviors (smoking, diet, exercise, or dental hygiene) was defined as an increase in any ladder score compared to baseline, assessed immediately, 6 weeks, and 6 months post-intervention. Subjects reported behavior change at each visit. We performed intent-to-treat analyses using generalized estimating equations for the binary outcome. Subjects randomized to PRE-RA were more likely to increase ladder scores over post-intervention assessments (relative risk 1.23, 95% confidence interval [95% CI] 1.01, 1.51) than those randomized to nonpersonalized education. At 6 months, 63.9% of PRE-RA subjects and 50.0% of comparison subjects increased motivation to improve behaviors (age-adjusted difference 15.8%; 95% CI 2.8%, 28.8%). Compared to nonpersonalized education, more PRE-RA subjects increased fish intake (45.0% versus 22.1%; P = 0.005), brushed more frequently (40.7% versus 22.9%; P = 0.01), flossed more frequently (55.7% versus 34.8%; P = 0.004), and quit smoking (62.5% versus 0.0% among 11 smokers; P = 0.18). Disclosure of RA risk personalized with genotype/biomarker results and behaviors increased motivation to improve RA risk-related behaviors. Personalized medicine approaches may motivate health

Extracorporeal shock wave therapy in patients with plantar fasciitis. A randomized, placebo-controlled trial with ultrasonographic and subjective outcome assessments

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Babak Vahdatpour

2012-01-01

Full Text Available Background and Aim: Results of previous studies have been conflicting on the efficacy of extracorporeal shock wave therapy (ESWT in the treatment of plantar fasciitis. We evaluated the effects of ESWT on plantar fasciitis in terms of ultrasonographic and subjective evaluations. Materials and Methods: In this randomized placebo-controlled trial, patients with plantar fasciitis were assigned to receive ESWT (4000 shock waves/session of 0.2 mJ/mm 2 in 3 sessions at weekly intervals or sham therapy (n = 20 in each group. Outcomes were documented by the ultrasonographic appearance of the aponeurosis and by patients′ pain scores, performed at baseline and 12 weeks after completion of the therapy. Results : The two groups were similar in baseline characteristics. Over the study period, plantar fascia thickness significantly reduced in the ESWT group (4.1 ± 1.3 to 3.6 ± 1.2 mm, P < 0.001, but slightly increased in the sham group (4.1 ± 0.8 to 4.5 ± 0.9 mm, P = 0.03. Both groups showed significant pain improvement over the course of the study (P < 0.001, though pain scores were significantly more reduced in the ESWT than the sham group (-4.2 ± 2.9 vs. -2.7 ± 1.8, P = 0.049. Conclusions: Extracorporeal shock wave therapy contributes to healing and pain reduction in plantar fasciitis and ultrasound imaging is able to depict the morphologic changes related to plantar fasciitis as a result of this therapy.

Evaluation of an ultra-low-dose oral contraceptive for dysmenorrhea: a placebo-controlled, double-blind, randomized trial.

Science.gov (United States)

Harada, Tasuku; Momoeda, Mikio

2016-12-01

To evaluate the efficacy and safety of an ultra-low-dose oral contraceptive (NPC-01; 0.02 mg ethinyl estradiol and 1 mg norethisterone) in subjects with dysmenorrhea. Placebo-controlled, double-blind, randomized trial. Clinical trial sites. Two hundred fifteen subjects with dysmenorrhea. Subjects were randomly assigned to receive NPC-01, placebo, or IKH-01 (0.035 mg ethinyl estradiol and 1 mg norethisterone) for four cycles. Total dysmenorrhea score (verbal rating scale) assessing pain on the basis of limited ability to work and need for analgesics. The reductions of total dysmenorrhea score and visual analog scale score after the treatment were significantly higher in the NPC-01 group than in the placebo group. Furthermore, the efficacy of NPC-01 was comparable to that of IKH-01. The overall incidence of side effects was significantly higher in the NPC-01 group than in the placebo group. All side effects that occurred in the NPC-01 group were previously reported in patients receiving IKH-01. No serious side effects occurred. The ultra-low-dose contraceptive NPC-01 relieved dysmenorrhea as effectively as IKH-01. Thus, NPC-01 could represent a new option for long-term treatment of dysmenorrhea. NCT01129102. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Efficacy and safety of lipegfilgrastim versus pegfilgrastim: a randomized, multicenter, active-control phase 3 trial in patients with breast cancer receiving doxorubicin/docetaxel chemotherapy

International Nuclear Information System (INIS)

Bondarenko, Igor; Gladkov, Oleg A; Elsaesser, Reiner; Buchner, Anton; Bias, Peter

2013-01-01

Lipegfilgrastim is a novel glyco-pegylated granulocyte-colony stimulating factor in development for neutropenia prophylaxis in cancer patients receiving chemotherapy. This phase III, double-blind, randomized, active-controlled, noninferiority trial compared the efficacy and safety of lipegfilgrastim versus pegfilgrastim in chemotherapy-naïve breast cancer patients receiving doxorubicin/docetaxel chemotherapy. Patients with high-risk stage II, III, or IV breast cancer and an absolute neutrophil count ≥1.5 × 10 9 cells/L were randomized to a single 6-mg subcutaneous injection of lipegfilgrastim (n = 101) or pegfilgrastim (n = 101) on day 2 of each 21-day chemotherapy cycle (4 cycles maximum). The primary efficacy endpoint was the duration of severe neutropenia during cycle 1. Cycle 1: The mean duration of severe neutropenia for the lipegfilgrastim and pegfilgrastim groups was 0.7 and 0.8 days, respectively (λ = −0.218 [95% confidence interval: –0.498%, 0.062%], p = 0.126), and no severe neutropenia was observed in 56% and 49% of patients in the lipegfilgrastim and pegfilgrastim groups, respectively. All cycles: In the efficacy population, febrile neutropenia occurred in three pegfilgrastim-treated patients (all in cycle 1) and zero lipegfilgrastim-treated patients. Drug-related adverse events in the safety population were reported in 28% and 26% of patients i006E the lipegfilgrastim and pegfilgrastim groups, respectively. This study demonstrates that lipegfilgrastim 6 mg is as effective as pegfilgrastim in reducing neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy. Eudra https://www.clinicaltrialsregister.eu/ctr-search/search?query The study protocol, two global amendments (Nos. 1 and 2), informed consent documents, and other appropriate study-related documents were reviewed and approved by the Ministry of Health of Ukraine Central Ethics Committee and local independent ethics committees (IECs)

Pharmacokinetics of a telmisartan/rosuvastatin fixed-dose combination: a single-dose, randomized, open-label, 2-period crossover study in healthy Korean subjects.

Science.gov (United States)

Chae, Dong Woo; Son, Mijeong; Kim, Yukyung; Son, Hankil; Jang, Seong Bok; Seo, Jeong Min; Nam, Su Youn; Park, Kyungsoo

2015-10-01

As hypertension and dyslipidemia are frequent comorbidities, antihypertensive drugs and lipid-lowering agents are often prescribed together for their treatment. Telmisartan and rosuvastatin are widely used together to treat hypertension and dyslipidemia. A combination formulation of these two drugs would improve patient compliance due to ease of dosing. The purpose of this study was to assess bioequivalence of single-dose administration of a newly-developed fixed-dose combination (FDC) tablet containing telmisartan/rosuvastatin 80/20 mg (test treatment) and coadministration of a telmisartan 80-mg tablet and a rosuvastatin 20-mg tablet (reference treatment) in healthy Korean male volunteers. This was a single-dose, randomized, open-label, 2-period crossover study enrolling healthy males aged 20 - 50 years with BMI between 18.5 and 25 kg/m2. Each subject received a single dose of the reference and test treatments with a 14-day washout period. Blood sampling was performed at prespecified intervals for up to 72 hours after dosing. Primary pharmacokinetic parameters were Cmax, AUClast, and AUC0-∞ of telmisartan, rosuvastatin, and N-desmethyl rosuvastatin. Bioequivalence was assessed by determining whether the 90% confidence intervals (CIs) of the geometric mean ratios (test treatment/reference treatment) of these parameters were within the standard range of 80% to 125%. Adverse events were monitored via regular interviews with the subjects and by physical examinations. 60 subjects were enrolled and 55 completed the study. The 90% CIs of the geometric mean ratios of Cmax, AUClast, and AUC00-∞ were 0.9262-1.1498, 0.9294-1.0313, and 0.9312-1.0320 for telmisartan, 0.9041-1.0428, 0.9262-1.0085, and 0.9307-1.0094 for rosuvastatin, and 0.8718-1.0022, 0.8901-0.9904, and 0.8872-0.9767 for N-desmethyl rosuvastatin, respectively. There was no statistical difference in the incidence of adverse events (AEs) (all of which were mild or moderate) between the reference and test

A randomized, placebo-controlled, preoperative trial of allopurinol in subjects with colorectal adenoma.

Science.gov (United States)

Puntoni, Matteo; Branchi, Daniela; Argusti, Alessandra; Zanardi, Silvia; Crosta, Cristiano; Meroni, Emanuele; Munizzi, Francesco; Michetti, Paolo; Coccia, Gianni; De Roberto, Giuseppe; Bandelloni, Roberto; Turbino, Laura; Minetti, Egle; Mori, Marco; Salvi, Sandra; Boccardo, Simona; Gatteschi, Beatrice; Benelli, Roberto; Sonzogni, Angelica; DeCensi, Andrea

2013-02-01

Inflammation and oxidative stress play a crucial role in the development of colorectal cancer (CRC) and interference with these mechanisms represents a strategy in CRC chemoprevention. Allopurinol, a safe molecular scavenger largely used as antigout agent, has been shown to increase survival of patients with advanced CRC and to reduce CRC incidence in long-term gout users in epidemiologic studies. We conducted a randomized, double-blind, placebo-controlled preoperative trial in subjects with colorectal adenomatous polyps to assess the activity of allopurinol on biomarkers of colorectal carcinogenesis. After complete colonoscopy and biopsy of the index polyp, 73 subjects with colorectal adenomas were assigned to either placebo or one of two doses of allopurinol (100 mg or 300 mg) and treated for four weeks before polyp removal. Change of Ki-67 labeling index in adenomatous tissue was the primary endpoint. Secondary endpoints were the immunohistochemical (IHC) expression of NF-κB, β-catenin, topoisomerase-II-α, and terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling (TUNEL) in adenomatous polyps and normal adjacent colonic tissue. Compared with placebo, Ki-67 levels were not significantly modulated by allopurinol, whereas β-catenin and NF-κB expression levels decreased significantly in adenomatous tissue, with a mean change from baseline of -10.6%, 95% confidence interval (CI), -20.5 to -0.7, and -8.1%, 95% CI, -22.7 to 6.5, respectively. NF-κB also decreased significantly in normal adjacent tissue (-16.4%; 95% CI, -29.0 to -3.8). No dose-response relationship was noted, except for NF-κB expression in normal tissue. Allopurinol can inhibit biomarkers of oxidative activation in colon adenomatous polyps and normal adjacent tissue. Further studies should define its potential chemopreventive activity.

Antioxidative Activity of Onion Peel Extract in Obese Women: A Randomized, Double-blind, Placebo Controlled Study.

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Kim, Kyung-Ah; Yim, Jung-Eun

2015-09-01

Quercetin, found abundantly in onion peel, has been known to have anticholesterol, antithrombotic and insulin-sensitizing properties. Here, we investigated the effect of quercetin-rich onion peel extract (OPE) on reactive oxygen species (ROS) production and antioxidative defense in obese woman. This study was randomized, double-blind, placebo controlled study. Thirty-seven healthy obese participants were randomly assigned that eighteen subjects received red soft capsuled OPE (100 mg/d, 50 mg bis in die), while the other nineteen subjects received same capsuled placebo for 12 weeks. ROS production and superoxide dismutase (SOD) activity in plasma were determined by using ROS and SOD assay kits, respectively. Baseline characteristics of anthropometric indicators and blood metabolic profiles were not significantly different between the two groups. Compared with baseline values, OPE consumption significantly reduced waist and hip circumference. Plasma ROS level and SOD activity were decreased in both placebo and OPE groups compared with baseline values. However, plasma ROS level in OPE group was significantly lower than in placebo group while plasma SOD activity in OPE group was significantly higher than in placebo group after 12 weeks of consumption. These findings indicate that OPE consumption may exert antioxidative effect by preventing the decrease of SOD activity as well as the production of ROS in obese women.

Fluid hydration to prevent post-ERCP pancreatitis in average- to high-risk patients receiving prophylactic rectal NSAIDs (FLUYT trial): study protocol for a randomized controlled trial.

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Smeets, Xavier J N M; da Costa, David W; Fockens, Paul; Mulder, Chris J J; Timmer, Robin; Kievit, Wietske; Zegers, Marieke; Bruno, Marco J; Besselink, Marc G H; Vleggaar, Frank P; van der Hulst, Rene W M; Poen, Alexander C; Heine, Gerbrand D N; Venneman, Niels G; Kolkman, Jeroen J; Baak, Lubbertus C; Römkens, Tessa E H; van Dijk, Sven M; Hallensleben, Nora D L; van de Vrie, Wim; Seerden, Tom C J; Tan, Adriaan C I T L; Voorburg, Annet M C J; Poley, Jan-Werner; Witteman, Ben J; Bhalla, Abha; Hadithi, Muhammed; Thijs, Willem J; Schwartz, Matthijs P; Vrolijk, Jan Maarten; Verdonk, Robert C; van Delft, Foke; Keulemans, Yolande; van Goor, Harry; Drenth, Joost P H; van Geenen, Erwin J M

2018-04-02

Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most common complication of ERCP and may run a severe course. Evidence suggests that vigorous periprocedural hydration can prevent PEP, but studies to date have significant methodological drawbacks. Importantly, evidence for its added value in patients already receiving prophylactic rectal non-steroidal anti-inflammatory drugs (NSAIDs) is lacking and the cost-effectiveness of the approach has not been investigated. We hypothesize that combination therapy of rectal NSAIDs and periprocedural hydration would significantly lower the incidence of post-ERCP pancreatitis compared to rectal NSAIDs alone in moderate- to high-risk patients undergoing ERCP. The FLUYT trial is a multicenter, parallel group, open label, superiority randomized controlled trial. A total of 826 moderate- to high-risk patients undergoing ERCP that receive prophylactic rectal NSAIDs will be randomized to a control group (no fluids or normal saline with a maximum of 1.5 mL/kg/h and 3 L/24 h) or intervention group (lactated Ringer's solution with 20 mL/kg over 60 min at start of ERCP, followed by 3 mL/kg/h for 8 h thereafter). The primary endpoint is the incidence of post-ERCP pancreatitis. Secondary endpoints include PEP severity, hydration-related complications, and cost-effectiveness. The FLUYT trial design, including hydration schedule, fluid type, and sample size, maximize its power of identifying a potential difference in post-ERCP pancreatitis incidence in patients receiving prophylactic rectal NSAIDs. EudraCT: 2015-000829-37 . Registered on 18 February 2015. 13659155 . Registered on 18 May 2015.

The Effect of Phytosterol on Serum Beta-Carotene Concentration of Hypercholesterolaemic Subjects

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S Dina-Keumala

2012-05-01

Full Text Available Objective: Treatment of optic neuritic as recommended by the Optic Neuritic Treatment Trial (ONTT was intravenous methylprednisolon followed by oral prednisone. This study aims to describe characteristics and response to intravenous methylprednisolone followed by oral prednisone treatment of optic neuritic patient in Sanglah General Hospital Denpasar. Method: The study was a parallel clinical trial, forty subjects with hipercholesterolaemia were selected using certain criteria. The subjects were divided into two groups using block randomization. Twenty subjects in phytosterol group received phytosterol 2x0.6 g/day and dietary counseling (P, while twenty subjects in counseling group received only dietary counseling (C. Serum total cholesterol and β-carotene concentration were assessed on day 0 and 42. Before and after treatment, dietary intake were assessed with 2x24 hour recall methods. Results: Seventeen subjects in P group and fourteen subjects in C group completed the study. There was no significant differences in baseline data both groups. After 42 days treatment, there was no significant differences in nutrients intakes in two groups except for β-carotene and phytosterol intakes in P group. There was a 9.17% significant reduction in serum total cholesterol concentration in P group while no change was observed in the C group (p<0.05. Serum β-carotene concentration was increased significantly in P group, 0.44±0.376 μmol/L to 0.536(0.21–1.95 μmol/L, while there was no significant increased in C group, 0.493±0.349 μmol/L to 0.56±0.33 μmol/L. There was a significant difference in serum β-carotene concentration after adjusted with serum total cholesterol concentration between two groups (p<0.05. Conclusions: Dietary advice to consume an additionally of high β-carotene sources when consuming phytosterol 2x0.6 g/day for 42 consecutive days maintains serum β-carotene concentration while lowering serum total cholesterol concentration

Gender differences in current received during transcranial electrical stimulation

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Michael eRussell

2014-08-01

Full Text Available Low current transcranial electrical stimulation is an effective but somewhat inconsistent tool for augmenting neuromodulation. In this study, we used 3D MRI guided electrical transcranial stimulation (GETS modeling to estimate the range of current intensities received at cortical brain tissues. Combined T1, T2, Proton Density MRIs from 24 adult subjects (12 male and 12 female were modeled with virtual electrodes placed at F3, F4, C3 and C4. Two sizes of electrodes 20 mm round and 50 x 45 mm square were examined at 0.5, 1 and 2 mA input currents. The intensity of current received was sampled in a one centimeter sphere placed at the cortex directly under each scalp electrode. There was a tenfold range in the current received by individuals. A large gender difference was observed with female subjects receiving significantly less current at targeted parietal cortex than male subjects when stimulated at identical current levels (P <0.05. Larger electrodes delivered somewhat larger amounts of current then the smaller ones (P <0.01. Electrodes in the frontal regions delivered less current than those in the parietal region (P<0.05. There were large individual differences in current levels the subjects received. Analysis of the cranial bone showed that the gender difference and the frontal parietal differences are due to differences in cranial bone. Males have more cancellous parietal bone and females more dense parietal bone (p<0.01. These differences should be considered when planning transcranial electrical stimulation studies and call into question earlier reports of gender differences due to hormonal influences.

The effects of physical training without equipment on pain perception and balance in the elderly: A randomized controlled trial

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Patti, Antonino; Bianco, Antonino; Karsten, Bettina; Montalto, Maria Alessandra; Battaglia, Giuseppe; Bellafiore, Marianna; Cassata, Daniela; Scoppa, Fabio; Paoli, Antonio; Iovane, Angelo; Messina, Giuseppe; Palma, Antonio

2017-01-01

BACKGROUND: Research supports a link between exercise and falls prevention in the older population. OBJECTIVES: Our aims were to evaluate pain perception and balance skills in a group of elderly subjects and to examine the consequences of a standardized equipment-free exercise program intervention on these variables. The study utilized a randomized controlled trial method. METHODS: 92 subjects were recruited from a rural Sicilian village (Resuttano, Sicily, Italy). Subjects were randomly split into two groups, an experimental group (EG; n = 49) and a control group (CG; n = 43). Qualified fitness instructors delivered the standardized physical exercise program for the EG whilst the CG did not receive this exercise intervention. The Berg Balance Scale and the Oswestry Disability Index were administered in both groups before (T0) and after the intervention (T1). RESULTS: At T1, the EG group significantly improvement in balance (p disability in elderly. PMID:28506013

Verapamil is Less Effective than Triamcinolone for Prevention of Keloid Scar Recurrence After Excision in a Randomized Controlled Trial

DEFF Research Database (Denmark)

Danielsen, Patricia L; Rea, Suzanne M; Wood, Fiona M

2016-01-01

per subject and each wound half randomized to receive intralesional injections of triamcinolone (10 mg/ml) or verapamil (2.5 mg/ml) at monthly intervals (4 doses). Interim analysis was performed after 14 subjects were completed. Survival analysis demonstrated significantly higher keloid recurrence...... with verapamil compared to triamcinolone 12 months post-surgery (log-rank test, p = 0.01) and higher overall risk of recurrence with verapamil (hazard ratio 8.44, 95% CI 1.62-44.05). The study was terminated early according to the stopping guideline (p safe but not as effective...

Autoshaping, random control, and omission training in the rat1

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Locurto, Charles; Terrace, H. S.; Gibbon, John

1976-01-01

The role of the stimulus-reinforcer contingency in the development and maintenance of lever contact responding was studied in hooded rats. In Experiment I, three groups of experimentally naive rats were trained either on autoshaping, omission training, or a random-control procedure. Subjects trained by the autoshaping procedure responded more consistently than did either random-control or omission-trained subjects. The probability of at least one lever contact per trial was slightly higher in subjects trained by the omission procedure than by the random-control procedure. However, these differences were not maintained during extended training, nor were they evident in total lever-contact frequencies. When omission and random-control subjects were switched to the autoshaping condition, lever contacts increased in all animals, but a pronounced retardation was observed in omission subjects relative to the random-control subjects. In addition, subjects originally exposed to the random-control procedure, and later switched to autoshaping, acquired more rapidly than naive subjects that were exposed only on the autoshaping procedure. In Experiment II, subjects originally trained by an autoshaping procedure were exposed either to an omission, a random-control, or an extinction procedure. No differences were observed among the groups either in the rate at which lever contacts decreased or in the frequency of lever contacts at the end of training. These data implicate prior experience in the interpretation of omission-training effects and suggest limitations in the influence of stimulus-reinforcer relations in autoshaping. PMID:16811960

Does robot-assisted gait training ameliorate gait abnormalities in multiple sclerosis? A pilot randomized-control trial.

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Straudi, S; Benedetti, M G; Venturini, E; Manca, M; Foti, C; Basaglia, N

2013-01-01

Gait disorders are common in multiple sclerosis (MS) and lead to a progressive reduction of function and quality of life. Test the effects of robot-assisted gait rehabilitation in MS subjects through a pilot randomized-controlled study. We enrolled MS subjects with Expanded Disability Status Scale scores within 4.5-6.5. The experimental group received 12 robot-assisted gait training sessions over 6 weeks. The control group received the same amount of conventional physiotherapy. Outcomes measures were both biomechanical assessment of gait, including kinematics and spatio-temporal parameters, and clinical test of walking endurance (six-minute walk test) and mobility (Up and Go Test). 16 subjects (n = 8 experimental group, n = 8 control group) were included in the final analysis. At baseline the two groups were similar in all variables, except for step length. Data showed walking endurance, as well as spatio-temporal gait parameters improvements after robot-assisted gait training. Pelvic antiversion and reduced hip extension during terminal stance ameliorated after aforementioned intervention. Robot-assisted gait training seems to be effective in increasing walking competency in MS subjects. Moreover, it could be helpful in restoring the kinematic of the hip and pelvis.

Comparative bioavailability and pharmacokinetics of two oral formulations of flurbiprofen: a single-dose, randomized, open-label, two-period, crossover study in Pakistani subjects.

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Qayyum, Aisha; Najmi, Muzammil Hasan; Abbas, Mateen

2013-11-01

Comparative bioavailability studies are conducted to establish the bioequivalence of generic formulation with that of branded reference formulation, providing confidence to clinicians to use these products interchangeably. This study was carried out to compare a locally manufactured formulation of flurbiprofen with that of a branded product. Twenty two healthy male adults received a single dose of flurbiprofen (100mg) either generic or branded product according to randomization scheme on each of 2 periods. Blood samples were collected and plasma flurbiprofen concentration was determined by a validated HPLC method. Pharmacokinetic parameters like AUC(0-t), AUC(0-oo), Cmax, Tmax, t½, Vd and clearance were determined. The 90% CI for the ratio of geometric means of test to reference product's pharmacokinetic variables was calculated. Pharmacokinetic parameters for two formulations were comparable. Ratio of means of AUC(0-24), AUC(0-oo) and Cmax for test to reference products and 90% CI for these ratios were within the acceptable range. The p-values calculated by TOST were much less than the specified value (p-0.05). ANOVA gave p-values which were more than the specified value (p-0.05) for sequence, subject, period and formulation. Test formulation of flurbiprofen (tablet Flurso) was found to meet the criteria for bioequivalence to branded product (tablet Ansaid) based on pharmacokinetic parameters.

Immediate effect of nonspecific mandibular mobilization on postural control in subjects with temporomandibular disorder: a single-blind, randomized, controlled clinical trial.

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Amaral, Ana P; Politti, Fabiano; Hage, Yasmin E; Arruda, Eric E C; Amorin, Cesar F; Biasotto-Gonzalez, Daniela A

2013-01-01

Temporomandibular disorder (TMD) is considered multifactorial and is defined as a group of pain conditions characterized by functional stomatognathic system alterations, which may be affected by or related disrupted postural control. Assess the immediate effect of nonspecific mandibular mobilization (NMM) on the postural control of subjects diagnosed or not with TMD. A simple-blind, randomized, controlled clinical trial was performed involving 50 subjects of both genders assigned to two groups: the TMD group and the control group. TMD was diagnosed according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). A stabilometric assessment was performed by testing subjects in a quiet stance on a dual force platform under two visual conditions (eyes open and eyes closed). The Center of Pressure (CoP)-related variables analyzed were displacement, amplitude, speed of anterior-posterior (AP) and medial-lateral (ML) displacements and CoP sway area. The mean values of each variable were compared, considering the accepted significance value of ppostural control in patients with TMD.

A whey-protein supplement increases fat loss and spares lean muscle in obese subjects: a randomized human clinical study

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Ward Loren S

2008-03-01

Full Text Available Abstract Background This study evaluated a specialized whey fraction (Prolibra™, high in leucine, bioactive peptides and milk calcium for use as a dietary supplement to enhance weight loss. Methods This was a randomized, double-blind, parallel-arm, 12-week study. Caloric intake was reduced 500 calories per day. Subjects consumed Prolibra or an isocaloric ready-to-mix beverage 20 minutes before breakfast and 20 minutes before dinner. Body fat and lean muscle tissue were measured by dual-energy x-ray absorptiometry (DEXA. Body weight and anthropometric measurements were recorded every 4 weeks. Blood samples were taken at the beginning and end of the study. Statistical analyses were performed on all subjects that completed (completer analysis and all subjects that lost at least 2.25 kg of body weight (responder analysis. Within group significance was determined at P Results Both groups lost a significant amount of weight and the Prolibra group tended to lose more weight than the control group; however the amount of weight loss was not significantly different between groups after 12 weeks. Prolibra subjects lost significantly more body fat compared to control subjects for both the completer (2.81 vs. 1.62 kg P = 0.03 and responder (3.63 vs. 2.11 kg, P = 0.01 groups. Prolibra subjects lost significantly less lean muscle mass in the responder group (1.07 vs. 2.41 kg, P = 0.02. The ratio of fat to lean loss (kg fat lost/kg lean lost was much larger for Prolibra subjects for both completer (3.75 vs. 1.05 and responder (3.39 vs. 0.88 groups. Conclusion Subjects in both the control and treatment group lost a significant amount of weight with a 500 calorie reduced diet. Subjects taking Prolibra lost significantly more body fat and showed a greater preservation of lean muscle compared to subjects consuming the control beverage. Because subjects taking Prolibra lost 6.1% of their body fat mass, and because a 5% reduction of body fat mass has been shown to

Geolocation of a Known Altitude Target Using TDOA and GROA in the Presence of Receiver Location Uncertainty

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Bing Deng

2016-01-01

Full Text Available This paper considers the problem of geolocating a target on the Earth surface using the target signal time difference of arrival (TDOA and gain ratio of arrival (GROA measurements when the receiver positions are subject to random errors. The geolocation Cramer-Rao lower bound (CRLB is derived and the performance improvement due to the use of target altitude information is quantified. An algebraic geolocation solution is developed and its approximate efficiency under small Gaussian noise is established analytically. Its sensitivity to the target altitude error is also studied. Simulations justify the validity of the theoretical developments and illustrate the good performance of the proposed geolocation method.

LONG TERM EFFECT OF CYRIAX PHYSIOTHERPY WITH SUPERVISED EXERCISE PROGRAM IN SUBJECTS WITH TENNIS ELBOW

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Pallavi Shridhar Thakare

2014-06-01

Full Text Available Background: The purpose is to find long term effect of Cyriax physiotherapy with supervised exercise program in the reduction of pain and improvement of functional ability for subjects with tennis elbow. Method: An experimental study design, 30 subjects with Tennis Elbow randomized 15 subjects each into Study and Control group. Control group received Supervised Exercise program while Study group received Cyriax Physiotherapy with Supervised exercises program thrice in a week for 4 weeks and post intervention follow up after 2 weeks. Outcome measurements were measured for pain using Visual analogue Scale (VAS and Patient Rated Tennis Elbow Evaluation (PRTEE for functional ability. Results: There is no statistically significant difference in pre- intervention means of VAS and PRTEE when compared between the groups using independent ‘t’ test as a parametric and Mann Whitney U test as a non-parametric test. When means of post intervention and follow-up measurements were compared there is a statistically significant (p<0.05 difference in VAS and PRTEE scores between the groups. However greater percentage of improvements was obtained in study group than control group. Conclusion: It is concluded that there is significant long term effect with greater percentage of improvement in pain and functional ability up to 2 weeks follow-up following 4 weeks of combined Cyriax physiotherapy with supervised exercise program than only supervised exercise program for subjects with tennis elbow.

Atomoxetine in abstinent cocaine users: Cognitive, subjective and cardiovascular effects.

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DeVito, Elise E; Herman, Aryeh I; Konkus, Noah S; Zhang, Huiping; Sofuoglu, Mehmet

2017-08-01

No pharmacotherapies are approved for the treatment of cocaine use disorders (CUD). Behavioral treatments for CUD are efficacious for some individuals, but recovery rates from CUD remain low. Cognitive impairments in CUD have been linked with poorer clinical outcomes. Cognitive enhancing pharmacotherapies have been proposed as promising treatments for CUD. Atomoxetine, a norepinephrine transporter inhibitor, shows potential as a treatment for CUD based on its efficacy as a cognitive enhancer in other clinical populations and impact on addictive processes in preclinical and human laboratory studies. In this randomized, double-blind, crossover study, abstinent individuals with CUD (N=39) received placebo, 40 and 80mg atomoxetine, over three sessions. Measures of attention, response inhibition and working memory; subjective medication effects and mood; and cardiovascular effects were collected. Analyses assessed acute, dose-dependent effects of atomoxetine. In addition, preliminary analyses investigating the modulation of atomoxetine dose effects by sex were performed. Atomoxetine increased heart rate and blood pressure, was rated as having positive and negative subjective drug effects, and had only modest effects on mood and cognitive enhancement. Copyright © 2017. Published by Elsevier Inc.

A randomized, controlled trial of aerobic exercise for treatment-related fatigue in men receiving radical external beam radiotherapy for localized prostate carcinoma.

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Windsor, Phyllis M; Nicol, Kathleen F; Potter, Joan

2004-08-01

Advice to rest and take things easy if patients become fatigued during radiotherapy may be detrimental. Aerobic walking improves physical functioning and has been an intervention for chemotherapy-related fatigue. A prospective, randomized, controlled trial was performed to determine whether aerobic exercise would reduce the incidence of fatigue and prevent deterioration in physical functioning during radiotherapy for localized prostate carcinoma. Sixty-six men were randomized before they received radical radiotherapy for localized prostate carcinoma, with 33 men randomized to an exercise group and 33 men randomized to a control group. Outcome measures were fatigue and distance walked in a modified shuttle test before and after radiotherapy. There were no significant between group differences noted with regard to fatigue scores at baseline (P = 0.55) or after 4 weeks of radiotherapy (P = 0.18). Men in the control group had significant increases in fatigue scores from baseline to the end of radiotherapy (P = 0.013), with no significant increases observed in the exercise group (P = 0.203). A nonsignificant reduction (2.4%) in shuttle test distance at the end of radiotherapy was observed in the control group; however, in the exercise group, there was a significant increase (13.2%) in distance walked (P = 0.0003). Men who followed advice to rest and take things easy if they became fatigued demonstrated a slight deterioration in physical functioning and a significant increase in fatigue at the end of radiotherapy. Home-based, moderate-intensity walking produced a significant improvement in physical functioning with no significant increase in fatigue. Improved physical functioning may be necessary to combat radiation fatigue.

Kinesio taping and manual pressure release: Short-term effects in subjects with myofasical trigger point.

Science.gov (United States)

Chao, Yu Wen; Lin, Jiu Jenq; Yang, Jing Lan; Wang, Wendy Tzyy-Jiuan

2016-01-01

Randomized controlled trial. Myofascial pain syndrome is characterized by myofascial trigger points (MTrPs) and fascia tenderness. We investigated the effects of manual pressure release (MPR) alone or in combination with taping (MPR/MKT) in subjects with MTrPs. Fifteen and 16 subjects received MPR and MPR/MKT respectively. Outcomes including Pressure pain threshold, muscle stiffness, mechanomyography were assessed at baseline, post-intervention and 7-days later. Pressure pain threshold improved significantly (d = 1.79, p < 0.005) in both groups. Significant improvement in muscle stiffness in the MPR/MKT group (0.27-0.49 mm) as compared to the MPR group (-0.02-0.23 mm). Mechanomyography amplitude in the MPR/MKT group was significantly higher than that of the MPR group (p < 0.05). MPR and MPR/MKT are effective in reducing pain in these subjects. MPR/MKT has a greater effect on muscle stiffness and contraction amplitude. IV. Copyright © 2016 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

Oral curcumin for Alzheimer's disease: tolerability and efficacy in a 24-week randomized, double blind, placebo-controlled study.

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Ringman, John M; Frautschy, Sally A; Teng, Edmond; Begum, Aynun N; Bardens, Jenny; Beigi, Maryam; Gylys, Karen H; Badmaev, Vladimir; Heath, Dennis D; Apostolova, Liana G; Porter, Verna; Vanek, Zeba; Marshall, Gad A; Hellemann, Gerhard; Sugar, Catherine; Masterman, Donna L; Montine, Thomas J; Cummings, Jeffrey L; Cole, Greg M

2012-01-01

Curcumin is a polyphenolic compound derived from the plant Curcuma Long Lin that has been demonstrated to have antioxidant and anti-inflammatory effects as well as effects on reducing beta-amyloid aggregation. It reduces pathology in transgenic models of Alzheimer's disease (AD) and is a promising candidate for treating human AD. The purpose of the current study is to generate tolerability and preliminary clinical and biomarker efficacy data on curcumin in persons with AD. We performed a 24-week randomized, double blind, placebo-controlled study of Curcumin C3 Complex(®) with an open-label extension to 48 weeks. Thirty-six persons with mild-to-moderate AD were randomized to receive placebo, 2 grams/day, or 4 grams/day of oral curcumin for 24 weeks. For weeks 24 through 48, subjects that were receiving curcumin continued with the same dose, while subjects previously receiving placebo were randomized in a 1:1 ratio to 2 grams/day or 4 grams/day. The primary outcome measures were incidence of adverse events, changes in clinical laboratory tests and the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) at 24 weeks in those completing the study. Secondary outcome measures included the Neuropsychiatric Inventory (NPI), the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) scale, levels of Aβ1-40 and Aβ1-42 in plasma and levels of Aβ1-42, t-tau, p-tau181 and F2-isoprostanes in cerebrospinal fluid. Plasma levels of curcumin and its metabolites up to four hours after drug administration were also measured. Mean age of completers (n = 30) was 73.5 years and mean Mini-Mental Status Examination (MMSE) score was 22.5. One subject withdrew in the placebo (8%, worsened memory) and 5/24 subjects withdrew in the curcumin group (21%, 3 due to gastrointestinal symptoms). Curcumin C3 Complex(®) was associated with lowered hematocrit and increased glucose levels that were clinically insignificant. There were no differences between

Effects of nattokinase on blood pressure: a randomized, controlled trial.

Science.gov (United States)

Kim, Ji Young; Gum, Si Nae; Paik, Jean Kyung; Lim, Hyo Hee; Kim, Kyong-Chol; Ogasawara, Kazuya; Inoue, Kenichi; Park, Sungha; Jang, Yangsoo; Lee, Jong Ho

2008-08-01

The objective of this study was to examine the effects of nattokinase supplementation on blood pressure in subjects with pre-hypertension or stage 1 hypertension. In a randomized, double-blind, placebo-controlled trial, 86 participants ranging from 20 to 80 years of age with an initial untreated systolic blood pressure (SBP) of 130 to 159 mmHg received nattokinase (2,000 FU/capsule) or a placebo capsule for 8 weeks. Seventy-three subjects completed the protocol. Compared with the control group, the net changes in SBP and diastolic blood pressure (DBP) were -5.55 mmHg (95% confidence interval [CI], -10.5 to -0.57 mmHg; pnattokinase group compared with the control group (pnattokinase supplementation resulted in a reduction in SBP and DBP. These findings suggest that increased intake of nattokinase may play an important role in preventing and treating hypertension.

Garcinia cambogia (hydroxycitric acid) as a potential antiobesity agent: a randomized controlled trial.

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Heymsfield, S B; Allison, D B; Vasselli, J R; Pietrobelli, A; Greenfield, D; Nunez, C

1998-11-11

Hydroxycitric acid, the active ingredient in the herbal compound Garcinia cambogia, competitively inhibits the extramitochondrial enzyme adenosine triphosphate-citrate (pro-3S)-lyase. As a citrate cleavage enzyme that may play an essential role in de novo lipogenesis inhibition, G cambogia is claimed to lower body weight and reduce fat mass in humans. To evaluate the efficacy of G cambogia for body weight and fat mass loss in overweight human subjects. Twelve-week randomized, double-blind, placebo-controlled trial. Outpatient weight control research unit. Overweight men and women subjects (mean body mass index [weight in kilograms divided by the square of height in meters], approximately 32 kg/m2). Subjects were randomized to receive either active herbal compound (1500 mg of hydroxycitric acid per day) or placebo, and both groups were prescribed a high-fiber, low-energy diet. The treatment period was 12 weeks. Body weight was evaluated every other week and fat mass was measured at weeks 0 and 12. Body weight change and fat mass change. A total of 135 subjects were randomized to either active hydroxycitric acid (n = 66) or placebo (n = 69); 42 (64%) in the active hydroxycitric acid group and 42 (61%) in the placebo group completed 12 weeks of treatment (P = .74). Patients in both groups lost a significant amount of weight during the 12-week treatment period (P<.001); however, between-group weight loss differences were not statistically significant (mean [SD], 3.2 [3.3] kg vs 4.1 [3.9] kg; P = .14). There were no significant differences in estimated percentage of body fat mass loss between treatment groups, and the fraction of subject weight loss as fat was not influenced by treatment group. Garcinia cambogia failed to produce significant weight loss and fat mass loss beyond that observed with placebo.

Advanced Signal Processing for MIMO-OFDM Receivers

DEFF Research Database (Denmark)

Manchón, Carles Navarro

This thesis deals with a wide range of topics within the research area of advanced baseband receiver design for wireless communication systems. In particular, the work focuses on signal processing algorithms for receivers in multiple-input multiple-output (MIMO) orthogonal frequency-division mult......This thesis deals with a wide range of topics within the research area of advanced baseband receiver design for wireless communication systems. In particular, the work focuses on signal processing algorithms for receivers in multiple-input multiple-output (MIMO) orthogonal frequency...... the structure of the receiver with the hope that the resulting heuristic architecture will exhibit the desired behavior and performance. On the other hand, one can employ analytical frameworks to pose the problem as the optimization of a global objective function subject to certain constraints. This work...

Is Subjective Status Influenced by Psychosocial Factors?

OpenAIRE

Lundberg, Johanna; Kristenson, Margareta

2008-01-01

Objective Associations between subjective status and health are still relatively unexplored. This study aimed at testing whether subjective status is uniquely confounded by psychosocial factors compared to objective status, and what factors that may predict subjective status. Design A cross-sectional analysis of a population-based, random sample of 795 middle-aged men and women from the southeast of Sweden. Questionnaires included subjective status, objective measures of socioeconomic status,...

Effect of Short-Term Fasting on Systemic Cytochrome P450-Mediated Drug Metabolism in Healthy Subjects: A Randomized, Controlled, Crossover Study Using a Cocktail Approach.

Science.gov (United States)

Lammers, Laureen A; Achterbergh, Roos; van Schaik, Ron H N; Romijn, Johannes A; Mathôt, Ron A A

2017-10-01

Short-term fasting can alter drug exposure but it is unknown whether this is an effect of altered oral bioavailability and/or systemic clearance. Therefore, the aim of our study was to assess the effect of short-term fasting on oral bioavailability and systemic clearance of different drugs. In a randomized, controlled, crossover trial, 12 healthy subjects received a single administration of a cytochrome P450 (CYP) probe cocktail, consisting of caffeine (CYP1A2), metoprolol (CYP2D6), midazolam (CYP3A4), omeprazole (CYP2C19) and warfarin (CYP2C9), on four occasions: an oral (1) and intravenous (2) administration after an overnight fast (control) and an oral (3) and intravenous (4) administration after 36 h of fasting. Pharmacokinetic parameters of the probe drugs were analyzed using the nonlinear mixed-effects modeling software NONMEM. Short-term fasting increased systemic caffeine clearance by 17% (p = 0.04) and metoprolol clearance by 13% (p < 0.01), whereas S-warfarin clearance decreased by 19% (p < 0.01). Fasting did not affect bioavailability. The study demonstrates that short-term fasting alters CYP-mediated drug metabolism in a non-uniform pattern without affecting oral bioavailability.

Oral sodium bicarbonate on the nutritional status of patients on chronic dialysis program: A randomized placebo controlled clinical trial

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Jaime Enríquez-Zarama

2013-06-01

Full Text Available Objective: To evaluate the therapeutic effect of oral sodium bicarbonate in improving the nutritional status of patients with chronic renal failure on chronic dialysis therapy (hemodialysis and peritoneal dialysis. Design: Randomized double blind placebo clinical trial. Setting: RTS Renal Units of Popayan, Colombia. Patients and Methods: 162 patients on chronic dialysis (hemodialysis and peritoneal dialysis were randomized to either placebo or bicarbonate. Patients received oral sodium bicarbonate, 1.0 g three times daily or placebo. Both groups received treatment for a 4-month period. Results: The study groups were comparable at the beginning of the study (study baseline and no significant differences were observed in any baseline parameters. At 4 months, the levels of albumin and Subjective Global Assessment (SGA improved with bicarbonate (p = 0.000, the malnutrition inflammation score and the score of malnutrition in dialysis with bicarbonate decreased significantly (p = 0.000. The PCR remained unchanged in both groups (p = 0,306. An increase of 20% or more from baseline serum albumin was observed in 6 (7.41% patients who received bicarbonate and 1 (1.23% of those receiving placebo (p = 0.02. At baseline albumin levels

Hormone therapy in menopausal women with cognitive complaints: a randomized, double-blind trial.

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Maki, P M; Gast, M J; Vieweg, A J; Burriss, S W; Yaffe, K

2007-09-25

To evaluate the effects of hormone therapy (HT) on cognition and subjective quality of life (QoL) in recently postmenopausal women with cognitive complaints. Cognitive Complaints in Early Menopause Trial (COGENT) was a randomized, double-blind, placebo-controlled, multicenter, pilot study of 180 healthy postmenopausal women aged 45 to 55 years, randomly assigned to receive either placebo or conjugated equine estrogen 0.625 mg/medroxyprogesterone acetate 2.5 mg for 4 months. Outcome measures included memory, subjective cognition, QoL, sexuality, and sleep, which were assessed at baseline and month 4. The study was terminated before the expected final sample size of 275 due to a decrease in enrollment coinciding with the publication of findings from the Women's Health Initiative. There were no differences between groups on any cognitive or QoL measures, except for an increase in sexual interest and thoughts with HT. Modest negative effects on short- and long-term verbal memory approached significance (p or=0.45, this study suggests potential modest negative effects on verbal memory that are consistent with previous hormone therapy trials in older women.

Evaluation of dentin hypersensitivity treatment with glass ionomer cements: A randomized clinical trial

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Marina de Matos MADRUGA

Full Text Available Abstract A randomized, double-blind, split-mouth clinical trial was performed compared the desensitizing efficacy of the resin-modified glass ionomer cement (GIC ClinproTM XT (3M ESPE, Minnesota, USA and the conventional GIC Vidrion R (SS White, Gloucester, UK in a 6-month follow-up. Subjects were required to have at least two teeth with dentin hypersensitivity. Teeth were divided at random into 2 groups, one group received Clinpro XT and the other conventional GIC Vidrion R. Treatments were assessed by tactile and air blast tests using Visual Analogue Scale (VAS at baseline, after 20 minutes, and at 7, 15, 21, 30, 90 and 180 days post-treatment. Twenty subjects (152 teeth were included. Both tests (tactile and air blast showed a significant reduction of dentin hypersensitivity immediately after the application of Vidrion R and Clinpro XT (20 min. VAS scores obtained along the 6-month follow-up were statistically lower when compared to initial rates (p 0.05. Both cements provided satisfactory results in long-term dental sensitivity reduction.

Randomized Caches Can Be Pretty Useful to Hard Real-Time Systems

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Enrico Mezzetti

2015-03-01

Full Text Available Cache randomization per se, and its viability for probabilistic timing analysis (PTA of critical real-time systems, are receiving increasingly close attention from the scientific community and the industrial practitioners. In fact, the very notion of introducing randomness and probabilities in time-critical systems has caused strenuous debates owing to the apparent clash that this idea has with the strictly deterministic view traditionally held for those systems. A paper recently appeared in LITES (Reineke, J. (2014. Randomized Caches Considered Harmful in Hard Real-Time Systems. LITES, 1(1, 03:1-03:13. provides a critical analysis of the weaknesses and risks entailed in using randomized caches in hard real-time systems. In order to provide the interested reader with a fuller, balanced appreciation of the subject matter, a critical analysis of the benefits brought about by that innovation should be provided also. This short paper addresses that need by revisiting the array of issues addressed in the cited work, in the light of the latest advances to the relevant state of the art. Accordingly, we show that the potential benefits of randomized caches do offset their limitations, causing them to be - when used in conjunction with PTA - a serious competitor to conventional designs.

IPP-rich milk protein hydrolysate lowers blood pressure in subjects with stage 1 hypertension, a randomized controlled trial

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Kloek Joris

2010-11-01

Full Text Available Abstract Background Milk derived peptides have been identified as potential antihypertensive agents. The primary objective was to investigate the effectiveness of IPP-rich milk protein hydrolysates (MPH on reducing blood pressure (BP as well as to investigate safety parameters and tolerability. The secondary objective was to confirm or falsify ACE inhibition as the mechanism underlying BP reductions by measuring plasma renin activity and angiotensin I and II. Methods We conducted a randomized, placebo-controlled, double blind, crossover study including 70 Caucasian subjects with prehypertension or stage 1 hypertension. Study treatments consisted of daily consumption of two capsules MPH1 (each containing 7.5 mg Isoleucine-Proline-Proline; IPP, MPH2 (each containing 6.6 mg Methionine-Alanine-Proline, 2.3 mg Leucine-Proline-Proline, 1.8 mg IPP, or placebo (containing cellulose for 4 weeks. Results In subjects with stage 1 hypertension, MPH1 lowered systolic BP by 3.8 mm Hg (P = 0.0080 and diastolic BP by 2.3 mm Hg (P = 0.0065 compared with placebo. In prehypertensive subjects, the differences in BP between MPH1 and placebo were not significant. MPH2 did not change BP significantly compared with placebo in stage I hypertensive or prehypertensive subjects. Intake of MPHs was well tolerated and safe. No treatment differences in hematology, clinical laboratory parameters or adverse effects were observed. No significant differences between MPHs and placebo were found in plasma renin activity, or angiotensin I and II. Conclusions MPH1, containing IPP and no minerals, exerts clinically relevant BP lowering effects in subjects with stage 1 hypertension. It may be included in lifestyle changes aiming to prevent or reduce high BP. Trial registration ClinicalTrials.gov NCT00471263

Intrinsic subtypes and benefit from postmastectomy radiotherapy in node-positive premenopausal breast cancer patients who received adjuvant chemotherapy - results from two independent randomized trials

DEFF Research Database (Denmark)

Laurberg, Tinne; Tramm, Trine; Nielsen, Torsten

2018-01-01

BACKGROUND: The study of the intrinsic molecular subtypes of breast cancer has revealed differences among them in terms of prognosis and response to chemotherapy and endocrine therapy. However, the ability of intrinsic subtypes to predict benefit from adjuvant radiotherapy has only been examined...... randomized to adjuvant radiotherapy or not. All patients received adjuvant chemotherapy and a subgroup of patients underwent ovarian ablation. Tumors were classified into intrinsic subtypes: Luminal A, Luminal B, HER2-enriched, Basal-like and Normal-like using the research-based PAM50 classifier. RESULTS...

SCRAED - Simple and Complex Random Assignment in Experimental Designs

OpenAIRE

Alferes, Valentim R.

2009-01-01

SCRAED is a package of 37 self-contained SPSS syntax files that performs simple and complex random assignment in experimental designs. For between-subjects designs, SCRAED includes simple random assignment (no restrictions, forced equal sizes, forced unequal sizes, and unequal probabilities), block random assignment (simple and generalized blocks), and stratified random assignment (no restrictions, forced equal sizes, forced unequal sizes, and unequal probabilities). For within-subject...

Analgesic Effect of Intraperitoneal Bupivacaine Hydrochloride After Laparoscopic Sleeve Gastrectomy: a Randomized Clinical Trial.

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Alamdari, Nasser Malekpour; Bakhtiyari, Mahmood; Gholizadeh, Barmak; Shariati, Catrine

2018-03-01

The indications for sleeve gastrectomy as a primary procedure for the surgical treatment of morbid obesity have increased worldwide. Pain is the most common complaint for patients on the first day after laparoscopic sleeve gastrectomy. There are various methods for decreasing pain after laparoscopic sleeve gastrectomy such as the use of intraperitoneal bupivacaine hydrochloride. This clinical trial was an attempt to discover the effects of intraperitoneal bupivacaine hydrochloride on alleviating postoperative pain after laparoscopic sleeve gastrectomy. In general, 120 patients meeting the inclusion criteria were enrolled. Patients were randomly allocated into two interventions and control groups using a balanced block randomization technique. One group received intraperitoneal bupivacaine hydrochloride (30 cm 3 ), and the other group served as the control one and did not receive bupivacaine hydrochloride. Diclofenac suppository and paracetamol injection were administered to both groups for postoperative pain management. The mean subjective postoperative pain score was significantly decreased in patients who received intraperitoneal bupivacaine hydrochloride within the first 24 h after the surgery; thus, the instillation of bupivacaine hydrochloride was beneficial in managing postoperative pain. The intraoperative peritoneal irrigation of bupivacaine hydrochloride (30 cm 3 , 0.25%) in sleeve gastrectomy patients was safe and effective in reducing postoperative pain, nausea, and vomiting (IRCT2016120329181N4).

Cluster randomization and political philosophy.

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Chwang, Eric

2012-11-01

In this paper, I will argue that, while the ethical issues raised by cluster randomization can be challenging, they are not new. My thesis divides neatly into two parts. In the first, easier part I argue that many of the ethical challenges posed by cluster randomized human subjects research are clearly present in other types of human subjects research, and so are not novel. In the second, more difficult part I discuss the thorniest ethical challenge for cluster randomized research--cases where consent is genuinely impractical to obtain. I argue that once again these cases require no new analytic insight; instead, we should look to political philosophy for guidance. In other words, the most serious ethical problem that arises in cluster randomized research also arises in political philosophy. © 2011 Blackwell Publishing Ltd.

Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

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Callahan Christopher M

2012-06-01

Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared

Internal Fat and Cardiometabolic Risk Factors Following a Meal-Replacement Regimen vs. Comprehensive Lifestyle Changes in Obese Subjects.

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König, Daniel; Zdzieblik, Denise; Deibert, Peter; Berg, Aloys; Gollhofer, Albert; Büchert, Martin

2015-12-01

The aim of the present study was to investigate the effect of a meal-replacement regimen vs. comprehensive lifestyle changes in overweight or obese subjects on intra-abdominal fat stores (Magnetic Resonance Imaging (MRI) measurements) and cardiometabolic risk factors. Forty-two obese men (n = 18) and women (n = 24) (age 49 ± 8 years; weight 96.3 ± 12.1 kg; BMI 32.7 ± 2.3 kg/m2) were selected for this randomized parallel-group design investigation. Subjects in the lifestyle group (LS-G; n = 22) received dietary counselling sessions and instructions how to increase physical activity. In the meal replacement group (MR-G; n = 20) meals were replaced by a low-calorie drink high in soy protein. After six months, subjects in the LS-G lost 8.88 ± 6.24 kg and subjects in the MR-G lost 7.1 ± 2.33 kg; p meal replacement group suggesting an additional effect of soy protein components.

Increased immunogenicity of the MF59-adjuvanted influenza vaccine compared to a conventional subunit vaccine in elderly subjects

International Nuclear Information System (INIS)

Gasparini, R.; Pozzi, T.; Montomoli, E.; Fragapane, E.; Senatore, F.; Minutello, M.; Podda, A.

2001-01-01

Three-hundred and eight outpatient elderly subjects (≥ 65 years) were randomly assigned to receive the MF59-adjuvanted influenza vaccine (FLUAD; n = 204) or a conventional subunit influenza vaccine (AGRIPPAL S1; n = 104) in order to compare the safety and immunogenicity of the two vaccines. Although mild pain at the injection site was reported more frequently by subjects immunised with the adjuvanted vaccine, both vaccines were shown to be safe and well tolerated. The adjuvanted vaccine was more immunogenic as indicated by higher post-immunisation geometric mean titres (GMTs) and by higher proportions of subjects with post-immunisation ≥ four fold increases of antibody titres or subjects with ≥ 1/160 post-immunisation HI titres. These differences, statistically significant for all three strains after immunisation, indicated that, by addition of the MF59 adjuvant emulsion, conventional subunit influenza antigens acquire an enhanced immunogenicity without any clinically significant increase of their reactogenicity

The effects of acupuncture versus sham acupuncture in the treatment of fibromyalgia: a randomized controlled clinical trial

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Fatma Gülçin Uğurlu

2017-01-01

Full Text Available Abstract OBJECTIVE: The aim of this manuscript is to determine and to compare the efficacy of real acupuncture with sham acupuncture on fibromyalgia (FM treatment. METHODS: 50 women with FM were randomized into 2 groups to receive either true acupuncture or sham acupuncture. Subjects were evaluated with VAS (at night, at rest, during activity, SF-36, Fibromyalgia Impact Questionnaire (FIQ, Beck Depression scale (BDI, Fatigue Severity Scale (FSS at baseline, 1 month and 2 months after the 1st session. Patients in both groups received 3 sessions in the 1st week, 2 sessions/week during 2 weeks and 1 session/week in the following 5 weeks (totally 12 sessions. RESULTS: 25 subjects with a mean age of 47,28±7,86 years were enrolled in true acupuncture group and 25 subjects with a mean age of 43,60±8,18 years were enrolled in sham acupuncture group. Both groups improved significantly in all parameters 1 month after the 1st session and this improvement persisted 2 months after the 1st session (p

A randomized comparison of patients' understanding of number needed to treat and other common risk reduction formats.

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Sheridan, Stacey L; Pignone, Michael P; Lewis, Carmen L

2003-11-01

Commentators have suggested that patients may understand quantitative information about treatment benefits better when they are presented as numbers needed to treat (NNT) rather than as absolute or relative risk reductions. To determine whether NNT helps patients interpret treatment benefits better than absolute risk reduction (ARR), relative risk reduction (RRR), or a combination of all three of these risk reduction presentations (COMBO). Randomized cross-sectional survey. University internal medicine clinic. Three hundred fifty-seven men and women, ages 50 to 80, who presented for health care. Subjects were given written information about the baseline risk of a hypothetical "disease Y" and were asked (1) to compare the benefits of two drug treatments for disease Y, stating which provided more benefit; and (2) to calculate the effect of one of those drug treatments on a given baseline risk of disease. Risk information was presented to each subject in one of four randomly allocated risk formats: NNT, ARR, RRR, or COMBO. When asked to state which of two treatments provided more benefit, subjects who received the RRR format responded correctly most often (60% correct vs 43% for COMBO, 42% for ARR, and 30% for NNT, P =.001). Most subjects were unable to calculate the effect of drug treatment on the given baseline risk of disease, although subjects receiving the RRR and ARR formats responded correctly more often (21% and 17% compared to 7% for COMBO and 6% for NNT, P =.004). Patients are best able to interpret the benefits of treatment when they are presented in an RRR format with a given baseline risk of disease. ARR also is easily interpreted. NNT is often misinterpreted by patients and should not be used alone to communicate risk to patients.

Mobile access to virtual randomization for investigator-initiated trials.

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Deserno, Thomas M; Keszei, András P

2017-08-01

Background/aims Randomization is indispensable in clinical trials in order to provide unbiased treatment allocation and a valid statistical inference. Improper handling of allocation lists can be avoided using central systems, for example, human-based services. However, central systems are unaffordable for investigator-initiated trials and might be inaccessible from some places, where study subjects need allocations. We propose mobile access to virtual randomization, where the randomization lists are non-existent and the appropriate allocation is computed on demand. Methods The core of the system architecture is an electronic data capture system or a clinical trial management system, which is extended by an R interface connecting the R server using the Java R Interface. Mobile devices communicate via the representational state transfer web services. Furthermore, a simple web-based setup allows configuring the appropriate statistics by non-statisticians. Our comprehensive R script supports simple randomization, restricted randomization using a random allocation rule, block randomization, and stratified randomization for un-blinded, single-blinded, and double-blinded trials. For each trial, the electronic data capture system or the clinical trial management system stores the randomization parameters and the subject assignments. Results Apps are provided for iOS and Android and subjects are randomized using smartphones. After logging onto the system, the user selects the trial and the subject, and the allocation number and treatment arm are displayed instantaneously and stored in the core system. So far, 156 subjects have been allocated from mobile devices serving five investigator-initiated trials. Conclusion Transforming pre-printed allocation lists into virtual ones ensures the correct conduct of trials and guarantees a strictly sequential processing in all trial sites. Covering 88% of all randomization models that are used in recent trials, virtual randomization

SHORT TERM EFFECT OF ACUPUNCTURE-TENS ON LUNG FUNCTIONS AND DYSPNEA FOR SUBJECTS WITH MODERATE COPD

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Vinod Babu. K

2015-10-01

Full Text Available Background: Acupuncture TENS is used to improve pain instead of invasive acupuncture. Acupuncture shown to improve dyspnoea and lung functions in COPD (Chronic Obstructive Pulmonary Disease patients. The purpose of the study is to determine Short term effectiveness of Acupuncture-TENS in reducing dyspnea and improving lung functions for subjects with moderate COPD. Method: An experimental study design, selected 30 geriatric subjects with COPD randomized 15 subjects into each Study and Control group. Study group received Acu-TENS for 45 minutes for total 5 sessions, while control group received placebo TENS. Outcome measurements such as breathlessness using Modified Borg Scale (MBS, Lung functions using Pulmonary Function Test (PFT was measured before and after intervention. Results: Analysis from pre-intervention to post-intervention within study group found that there is statistically significant change in means of MBS, FEV1, FEV1/FVC ratio and within control group there is a statistically significant change in means of MBS, but there is no statistically significant change in means of FEV1, FVC and FEV1/FVC ratio. When post-intervention means were compared between the groups there is no statistically significant difference in means of MBS and FEV1, FVC and FEV1/FVC ratio. Conclusion: It is concluded that one week of Acu-TENS on EXL1 point found no significant effect on improving dyspnea and lung functions in subjects with moderate COPD in geriatric populations.

Effect of aerobic exercises versus laser acupuncture in treatment of postmenopausal hot flushes: a randomized controlled trial.

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Elhosary, Eman Abdelfatah Mohamed; Ewidea, Mahmoud Mohamed; Ahmed, Hamada Ahmed Hamada; El Khatib, Ayman

2018-02-01

[Purpose] To compare the effect of aerobic exercises versus laser acupuncture in treatment of postmenopausal hot flushes. [Subjects and Methods] This study was designed as single blind randomized controlled trial. A total of 48 postmenopausal women complained of hot flushes. Their ages ranged between 45 to 55 years and were randomly assigned into 2 equal groups: group (A), which received an aerobic exercises, and group (B), which received laser acupuncture. Both groups recieved 3 sessions per week for two months. The level of follicular stimulating hormone, lutelizing hormone, and hot flushes dairy card were assessed the severity of hot flahes before and after treatment program. [Results] There were Significant reduction in FSH, LH, and menopausal daily hot flush scale in group A compared with group B at the post treatment. [Conclusion] Eight week program of an aerobic exercises yields improvement in FSH, LH, and decrease in severity of hot flushes assessed by hot flush dairy card than laser acupuncture in the treatment of postmenopausal hot flashes.

Comparing Relaxation Programs for Breast Cancer Patients Receiving Radiotherapy

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In this study, women with breast cancer who have had surgery and are scheduled to undergo radiation therapy will be randomly assigned to one of two different stretching and relaxation programs or to a control group that will receive usual care.

Pain in adolescent girls receiving human papillomavirus vaccine with concomitantly administered vaccines.

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Walter, Emmanuel B; Kemper, Alex R; Dolor, Rowena J; Dunne, Eileen F

2015-02-01

Using the Faces Pain Scale - Revised, we assessed injection site pain 10 minutes after vaccination in young females randomized to receive either quadrivalent human papillomavirus vaccine (HPV4) before or after concomitantly administered vaccines. Although pain was modestly more after HPV4 injection than after other vaccines, the pain intensity after HPV4 injection was significantly less in those who received HPV4 before receiving other concomitant vaccines.

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

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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 ...

Effect of nonsurgical periodontal therapy verses oral hygiene instructions on type 2 diabetes subjects with chronic periodontitis: a randomised clinical trial.

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Raman, Renukanth Patabi Cheta; Taiyeb-Ali, Tara Bai; Chan, Siew Pheng; Chinna, Karuthan; Vaithilingam, Rathna Devi

2014-06-25

40 subjects with type 2 diabetes and moderate to severe CP were randomly distributed to groups receiving either NSPT or OHI. Periodontal parameters, glycosylated haemoglobin (HbA1c) and high-sensitivity C-reactive protein (hs-CRP) were evaluated at baseline, 2- and 3-months intervals. 40 subjects with type 2 diabetes and moderate to severe CP were randomly distributed to groups receiving either NSPT or OHI. Periodontal parameters, glycosylated haemoglobin (HbA1c) and high-sensitivity C-reactive protein (hs-CRP) were evaluated at baseline, 2- and 3-months intervals. 15 subjects from NSPT group and 17 from OHI group completed the study. The difference in plaque index (PI) between NSPT and OHI groups were significant at 2 months recall (p = 0.013). There was no significant difference between NSPT and OHI group for all other clinical periodontal parameters, HbA1c and CRP levels. At 3 months post-therapy, periodontal parameters improved significantly in both groups with sites with probing pocket depth (PPD) c levels decreased in both groups with NSPT group recording statistically significant reduction (p = 0.038). Participants who demonstrated ≥ 50% reduction in PPD showed significant reductions of HbA1c and hs-CRP levels (p = 0.004 and p = 0.012). NSPT significantly reduced PI at 2 months post-therapy as compared to OHI. Both NSPT and OHI demonstrated improvements in other clinical parameters as well as HbA1c and CRP levels. ClinicalTrials.gov: NCT01951547.

Partial-thickness burn wounds healing by topical treatment: A randomized controlled comparison between silver sulfadiazine and centiderm.

Science.gov (United States)

Saeidinia, Amin; Keihanian, Faeze; Lashkari, Ardalan Pasdaran; Lahiji, Hossein Ghavvami; Mobayyen, Mohammadreza; Heidarzade, Abtin; Golchai, Javad

2017-03-01

Burns are common event and associated with a high incidence of death, disability, and high costs. Centella asiatica (L.) is a medicinal herb, commonly growing in humid areas in several tropical countries that improve wound healing. On the basis of previous studies, we compared the efficacy of Centiderm versus silver sulfadiazine (SSD) in partial thickness burning patients. Study population comprised burn victims referred to Velayat Burning Hospital at Rasht, Iran. The intervention group received Centiderm and control group SSD cream. Burn wounds were treated once daily at home. All of the wounds were evaluated till complete healing occurred and at the admission, days 3, 7, 14 objective signs; visual acuity score (VAS) and subjective signs were recorded. Re-epithelialization time and complete healing days were recorded. We used random fixed block for randomization. The randomization sequence was created using the computer. Patients and burning specialist physician were blinded. Seventy-five patients randomized into 2 groups; (40 patients: Centiderm group; 35 patients: SSD group). The mean age of them was 30.67 ± 9.91 years and 19 of them were male (31.7%). Thirty patients in Centiderm and 30 patients in SSD group were analyzed. All of objective and subjective signs and mean of re-epithelialization and complete healing were significantly better in Centiderm group rather than SSD group (P < 0.05). There was no infection in Centiderm group. We showed that use of Centiderm ointment not only improved the objective and subjective signs in less than 3 days, but also the re-epithelialization and complete healing rather than SSD without any infection in the subjects.

Meditation and Music Improve Memory and Cognitive Function in Adults with Subjective Cognitive Decline: A Pilot Randomized Controlled Trial.

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Innes, Kim E; Selfe, Terry Kit; Khalsa, Dharma Singh; Kandati, Sahiti

2017-01-01

While effective therapies for preventing or slowing cognitive decline in at-risk populations remain elusive, evidence suggests mind-body interventions may hold promise. In this study, we assessed the effects of Kirtan Kriya meditation (KK) and music listening (ML) on cognitive outcomes in adults experiencing subjective cognitive decline (SCD), a strong predictor of Alzheimer's disease. Sixty participants with SCD were randomized to a KK or ML program and asked to practice 12 minutes/day for 3 months, then at their discretion for the ensuing 3 months. At baseline, 3 months, and 6 months we measured memory and cognitive functioning [Memory Functioning Questionnaire (MFQ), Trail-making Test (TMT-A/B), and Digit-Symbol Substitution Test (DSST)]. The 6-month study was completed by 53 participants (88%). Participants performed an average of 93% (91% KK, 94% ML) of sessions in the first 3 months, and 71% (68% KK, 74% ML) during the 3-month, practice-optional, follow-up period. Both groups showed marked and significant improvements at 3 months in memory and cognitive performance (MFQ, DSST, TMT-A/B; p's≤0.04). At 6 months, overall gains were maintained or improved (p's≤0.006), with effect sizes ranging from medium (DSST, ML group) to large (DSST, KK group; TMT-A/B, MFQ). Changes were unrelated to treatment expectancies and did not differ by age, gender, baseline cognition scores, or other factors. Findings of this preliminary randomized controlled trial suggest practice of meditation or ML can significantly enhance both subjective memory function and objective cognitive performance in adults with SCD, and may offer promise for improving outcomes in this population.

Impact of preoperative information on anxiety and disease-related knowledge in women undergoing mastectomy for breast cancer: a randomized clinical trial.

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Wysocki, W M; Mituś, J; Komorowski, A L; Karolewski, K

2012-01-01

Despite the large number of clinical trials on breast cancer, patient-related factors such as perioperative anxiety and level of knowledge about the disease and treatment have not been included in mainstream research efforts. This randomized trial was performed to evaluate the impact of information, provided preoperatively, on anxiety and knowledge of women undergoing mastectomy for breast cancer. Sixty consecutive patients with breast cancer, admitted for a mastectomy, as primary treatment for breast cancer, with no previous cancer history, were randomized to receive structured information (short video about practical aspects of the hospital stay, surgical and adjuvant treatment) in addition to the routine informed consent procedure for surgery or the routine informed consent only. Anxiety and subjective knowledge levels were measured with the visual analogue scales; in addition, knowledge was assessed with a questionnaire. There was no significant effect of the additional information on perioperative anxiety or knowledge (subjective). Significantly more patients in the additional information group correctly listed all major available treatment options compared to the patients that received routine information (preoperatively 54% vs. 19%; p = 0.0101; 7 days postoperatively 50% vs.19%; p = 0.0367). Use of an informational video, preoperatively, did not significantly affect perioperative anxiety or subjective knowledge. Additional research is needed on effective delivery of disease- and treatment-specific information perioperatively.

Evaluation of a multi-herb supplement for erectile dysfunction: a randomized double-blind, placebo-controlled study

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Shah Gaurang R

2012-09-01

Full Text Available Abstract Background Evidence is lacking for multi-ingredient herbal supplements claiming therapeutic effect in sexual dysfunction in men. We examined the safety and efficacy of VigRX Plus (VXP – a proprietary polyherbal preparation for improving male sexual function, in a double blind, randomized placebo-controlled, parallel groups, multi-centre study. Methods 78 men aged 25–50 years of age; suffering from mild to moderate erectile dysfunction (ED, participated in this study. Subjects were randomized to receive VXP or placebo at a dose of two capsules twice daily for 12 weeks. The international index of erectile function (IIEF was the primary outcome measure of efficacy. Other efficacy measures were: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS, Serum testosterone, Semen analysis, Investigator’s Global assessment and Subjects’ opinion. Results In subjects receiving VXP, the IIEF-Erectile Function (EF scores improved significantly as compared to placebo. After 12 weeks of treatment, the mean (sd IIEF-EF score at baseline increased from 16.08 (2.87 to 25.08 (4.56 in the VXP group versus 15.86 (3.24 to 16.47 (4.25 in the placebo group (P P  Conclusions VigRX Plus was well tolerated and more effective than placebo in improving sexual function in men. Trial Registration Clinical Trial Registry India, CTRI/2009/091/000099, 31-03-2009

The Views Of Cancer Patients On Receiving Bad News

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Hatice Bostanoglu Fesci

2011-06-01

Full Text Available AIM: This study was performed in a descriptive matter to determine the views of inpatients at an oncology state hospital on receiving bad news. METHOD: The study sample consisted of 237 inpatients (155 females, 82 males at an oncology state hospital between October and November 2008 who were determined using the random sampling method and accepted participating in the study. The data collection tool used was a survey form that consisted of 24 questions related to the sociodemographic features and views on receiving bad news. RESULTS: The mean age of the study subjects was 53.1±13.9 (min.=18, max.=83. The patients were undergoing the treatment process in 84% and the diagnostic process in 16%. The bad news had been given by the physician in 87.8% and while in the physician's room in 74.8%. The patients had been told while receiving the bad news that 'there is a mass/problem/lesion/tumor and you will undergo surgery' in 47.7% while 24.9% had been told that they had cancer directly. The patients stated that they froze, fainted, were shocked, felt their life was shattered and experienced emotions such as sadness, fear, hopelessness, sorrow, disappointment, desperation, etc. at a rate of 93.7%. We found that 58.2% of the patients had not been given an opportunity to express their emotions when they received the bad news, 67.4% preferred to have a relative with them at the time, 40.9% felt that the bad news should be given in a special environment, 30% wanted the bad news to be given as soon as the diagnosis was known while 36.7% preferred being told everything about the disease when receiving the bad news CONCLUSION: Taking into account the information content, family participation, and the individual preferences of the patients regarding time and place when giving bad news and encouraging them to ask questions and express themselves may make it easier for the patients to cope with bad news. [TAF Prev Med Bull 2011; 10(3.000: 319-326

A randomized controlled trial to improve health among women receiving welfare in the US: the relationship between employment outcomes and the economic recession.

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Kneipp, Shawn M; Kairalla, John A; Sheely, Amanda L

2013-03-01

The high prevalence of health conditions among U.S. women receiving Temporary Assistance for Needy Families (TANF, or 'welfare') impedes the ability of many in this group to move from 'welfare-to-work', and the economic recession has likely exacerbated this problem. Despite this, few interventions have been developed to improve employment outcomes by addressing the health needs of women receiving TANF, and little is known about the impact of economic downturns on the employment trajectory of this group. Using data from a recent randomized controlled trial (RCT) that tested the efficacy of a public health nursing (PHN) intervention to address the chronic health condition needs of 432 American women receiving TANF, we examine the effect of the intervention and of recession exposure on employment. We further explore whether intervention effects were modified by select sociodemographic and health characteristics. Both marginal and more robust intervention effects were noted for employment-entry outcomes (any employment, p = 0.05 and time-to-employment, p = 0.01). There were significant effects for recession exposure on employment-entry (any employment, p = 0.002 and time-to-employment, p understanding of the health and employment dynamics among this group of disadvantaged women under variable macroeconomic conditions, and have implications for guiding health and TANF-related policy. Copyright © 2012 Elsevier Ltd. All rights reserved.

The effects of phytosterol in low fat milk on serum lipid levels among mild-moderately hypercholesterolemic subjects

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Sri Sukmaniah

2008-03-01

Full Text Available One of the most important risk factors for CHD is dyslipidemia, among others hypercholesterolemia or high LDL-cholesterol. Plant-sterols or phytosterols (PS are among dietary factors known to lower blood cholesterol as part of therapeutic life-style changes diet. This study was aimed to evaluate the effect of PS properly solubilized in a-partly vegetable oil-filled low fat milk, on serum lipid levels in mild-moderate hypercholesterolemic subjects. Randomized, two-arm parallel control group trial was conducted at Department of Nutrition-University of Indonesia in Jakarta from June to November 2006. Each subject was randomly assigned to receive dietary life-style changes counseling plus 1.2 g phytosterol/day in low-fat milk (PS-group or control group receiving the counseling alone for six weeks period. There were no significant changes of serum total and LDL-cholesterol of control group after a six week of dietary counseling (respectively 218.3 ± 18.6 mg/dL to 219.6 ± 24.3 mg/dL and 164.7±21.8 mg/dL to 160.0±26.4 mg/dL. There were a significant decreases of serum total and LDL-cholesterol (respectively p=0.01 and p=0.004 among subjects receiving PS after a six weeks observation period (respectively 233.5±24.6 mg/dL to 211.2±30.3 mg/dL and 176.9±24.7 mg/dL to 154.5±24.3 mg/dL. There was a significant difference in the LDL-lowering effects (p=0.024 among the PS-group after a six weeks (22.4±27.9 mg/dL as compared to the control group (4.7±17.2 mg/dL. No significant changes were found on serum HDL-cholesterol and triglyceride levels in both groups. Although there was no significant difference found in daily nutrients intake between the-2 groups, however, significant reductions in body weight, body mass index and waist circumference were found only in the PS group (p=0.000; 0.000; 0.003, respectively. It is concluded that the lowering of total and LDL-cholesterol in those receiving life-style changes counseling plus 1.2 g PS daily for six

Random number generation and creativity.

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Bains, William

2008-01-01

A previous paper suggested that humans can generate genuinely random numbers. I tested this hypothesis by repeating the experiment with a larger number of highly numerate subjects, asking them to call out a sequence of digits selected from 0 through 9. The resulting sequences were substantially non-random, with an excess of sequential pairs of numbers and a deficit of repeats of the same number, in line with previous literature. However, the previous literature suggests that humans generate random numbers with substantial conscious effort, and distractions which reduce that effort reduce the randomness of the numbers. I reduced my subjects' concentration by asking them to call out in another language, and with alcohol - neither affected the randomness of their responses. This suggests that the ability to generate random numbers is a 'basic' function of the human mind, even if those numbers are not mathematically 'random'. I hypothesise that there is a 'creativity' mechanism, while not truly random, provides novelty as part of the mind's defence against closed programming loops, and that testing for the effects seen here in people more or less familiar with numbers or with spontaneous creativity could identify more features of this process. It is possible that training to perform better at simple random generation tasks could help to increase creativity, through training people to reduce the conscious mind's suppression of the 'spontaneous', creative response to new questions.

Effect of Guava in Blood Glucose and Lipid Profile in Healthy Human Subjects: A Randomized Controlled Study

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Rakavi, R; Mangaraj, Manaswini

2016-01-01

Introduction The fruit of Psidium guajava (P.guajava) is known to contain free sugars yet the fruit juice showed hypoglycaemic effect. Hypoglycaemic activity of guava leaves has been well documented but not for guava fruit. Aim So we aimed to evaluate the effect of ripe guava (with peel and without peel) fruit supplementation on blood glucose and lipid profile in healthy human subjects. Materials and Methods Randomized Controlled study undertaken in: 1) Baseline; 2) 6 weeks supplementation phase. Forty five healthy MBBS students were included and randomly enrolled into Group A, Group B and Group C. In Baseline phase: Fasting Plasma Glucose (FPG) and serum lipid profile was done in all 3 groups. Group A were supplemented with 400g of ripe guava with peel and group B without peel, for 6 weeks. Rest 15 treated as control i.e., Group C. Result Supplementation of ripe guava fruit with peel reduced BMI as well as blood pressure (pguava pulp supplementation was not significant. Serum Total cholesterol, Triglycerides and Low Density Lipoprotein Cholesterol (LDLc) levels decreased significantly (pguava pulp without peel may have a favourable effect on lipid levels and blood sugar as well. Conclusion Guava fruit without peel is more effective in lowering blood sugar as well as serum total cholesterol, triglycerides and LDLc. It increases HDLc levels also. PMID:27790420

Effects of nanotechnologies-based devices on postural control in healthy subjects.

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Malchiodi Albedi, Giovanna; Corna, Stefano; Aspesi, Valentina; Clerici, Daniela; Parisio, Cinzia; Seitanidis, Jonathan; Cau, Nicola; Brugliera, Luigia; Capodaglio, Paolo

2017-09-05

The aim of the present preliminary randomized controlled study was to ascertain whether the use of newly developed nanotechnologies-based patches can influence posture control of healthy subjects. Thirty healthy female subjects (age 39.4 years, BMI 22.74 kg/m2) were randomly assigned to two groups: one with active patches and a control group with sham patches. Two patches were applied with a tape: one on the subject's sternum and the other on the C7 apophysis. Body sway during quiet upright stance was recorded with a dynamometric platform. Each subject was tested under two visual conditions, eyes open and closed. We used a blocked stratified randomization procedure conducted by a third party. Subjects wearing the sham patches showed a significant increase of the centre of pressure sway area after 4 hours when they performed the habitual moderate-intensity work activities. In the active patch group, a decrease of the sway path was evident, providing evidence of an enhanced balance control. Our preliminary findings on healthy subjects indicate that nanotechnological devices generating ultra-low electromagnetic fields can improve posture control.

Effects of Three Low-Doses of D-Tagatose on Glycemic Control Over Six Months in Subjects with Mild Type 2 Diabetes Mellitus Under Control with Diet and Exercise

OpenAIRE

Ensor, Mark; Williams, Jarrod; Smith, Rebecca; Banfield, Amy; Lodder, Robert A.

2014-01-01

The primary objective of this study was to evaluate the safety and the effect of D-tagatose on the glycemic control of subjects with type 2 diabetes as determined by HbA1c levels at the end of 6 months of therapy using the subject’s own baseline HbA1c level as a comparator. The determination of the minimal dose required to cause a statistically significant reduction in HbA1c was of particular interest. Eight weeks after screening, the qualifying subjects were randomized to receive one of thre...

Evaluation of a multi-herb supplement for erectile dysfunction: a randomized double-blind, placebo-controlled study.

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Shah, Gaurang R; Chaudhari, Manojkumar V; Patankar, Suresh B; Pensalwar, Shrikant V; Sabale, Vilas P; Sonawane, Navneet A

2012-09-15

Evidence is lacking for multi-ingredient herbal supplements claiming therapeutic effect in sexual dysfunction in men. We examined the safety and efficacy of VigRX Plus (VXP) - a proprietary polyherbal preparation for improving male sexual function, in a double blind, randomized placebo-controlled, parallel groups, multi-centre study. 78 men aged 25-50 years of age; suffering from mild to moderate erectile dysfunction (ED), participated in this study. Subjects were randomized to receive VXP or placebo at a dose of two capsules twice daily for 12 weeks. The international index of erectile function (IIEF) was the primary outcome measure of efficacy. Other efficacy measures were: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), Serum testosterone, Semen analysis, Investigator's Global assessment and Subjects' opinion. In subjects receiving VXP, the IIEF-Erectile Function (EF) scores improved significantly as compared to placebo. After 12 weeks of treatment, the mean (sd) IIEF-EF score at baseline increased from 16.08 (2.87) to 25.08 (4.56) in the VXP group versus 15.86 (3.24) to 16.47 (4.25) in the placebo group (P sexual desire, intercourse satisfaction, and overall satisfaction).There was a significant difference for VXP versus placebo comparison of mean (sd) EDITS scores of patients: 82.31(20.23) vs 36.78(22.53) and partners :(82.75(9.8) vs 18.50(9.44);P global assessment rated VXP therapy as very good to excellent in more than 50% patients and placebo therapy as fair to good in about 25% of patients. Incidence of side effects and subject's rating for tolerability of treatment was similar in both groups. VigRX Plus was well tolerated and more effective than placebo in improving sexual function in men. Clinical Trial Registry India, CTRI/2009/091/000099, 31-03-2009.

A randomized 3-month clinical comparison of a power toothbrush to a manual toothbrush in the reduction of gingivitis.

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Li, Zhen; He, Tao; Li, Chun; Sun, Lily; Chang, Jinlan; He, Yanyan; Zhao, Jizhi; Ji, Ning

2016-08-01

To compare the anti-gingivitis effect of a power toothbrush relative to a manual toothbrush control. This was a 3-month, randomized and controlled, single-center, parallel group, examiner-blinded clinical study. 123 Chinese adults in good general health and with at least 15 gingival bleeding sites, as measured by the Gingival Bleeding Index, were enrolled into the study. At baseline, pre-treatment gingivitis levels were assessed using the Mazza Bleeding Index. Subjects were then randomly assigned to receive either an oscillating-rotating power toothbrush [Oral-B Professional Care 7000 (D17u/EB17)] or a flat-trim manual toothbrush with tapered filaments (Lion Dentor Systema). Subjects brushed at home twice-daily with their assigned toothbrush and a marketed sodium fluoride dentifrice (Crest Cavity Protection dentifrice), and were reevaluated at Months 1, 2, and 3. 113 evaluable subjects completed the study. Both groups showed significant reductions in gingivitis from baseline for all time points measured (Pgingivitis reductions of 7.11%, 9.20% and 8.47%, respectively, than the manual toothbrush (Pgingivitis compared with a manual toothbrush at Months 1, 2 and 3.

Randomized controlled trial of a protein substitute with prolonged release on the protein status of children with phenylketonuria.

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Giovannini, Marcello; Riva, Enrica; Salvatici, Elisabetta; Cefalo, Graziella; Radaelli, Giovanni

2014-01-01

To examine whether a phenylalanine-free protein substitute with prolonged release may be beneficial to the protein status of children with phenylketonuria (PKU) compared to conventional substitutes. Sixty children with PKU, 7 to 16 years of age, were randomly allocated to receive either a prolonged-release (test) or the current conventional protein substitute for 30 days. Subjects were additionally sex and age matched with 60 subjects with mild hyperphenylalaninemia and 60 unaffected subjects. The protein status in children with PKU was assessed by albumin, transthyretin, and retinol-binding protein (RBP), and changes throughout the trial period were the primary outcome measures. Children with PKU did not differ in anthropometry from children with mild hyperphenylalaninemia or unaffected children but they ingested lower amounts of proteins (p phenylketonuria.

User's guide for MIRVAL: a computer code for comparing designs of heliostat-receiver optics for central receiver solar power plants

Energy Technology Data Exchange (ETDEWEB)

Leary, P L; Hankins, J D

1979-02-01

MIRVAL is a Monte Carlo program which simulates the heliostats and a portion of the receiver for solar energy central receiver power plants. Models for three receiver types and four kinds of heliostats are included in the code. The three receiver types modeled are an external cylinder, a cylindrical cavity with a downward-facing aperature, and a north-facing cavity. Three heliostats which track in elevation and azimuth are modeled, one of which is enclosed in a plastic dome. The fourth type consists of a rack of louvered reflective panels with the rack rotatable about a fixed horizontal axis. Phenomena whose effects are simulated are shadowing, blocking, mirror tracking, random errors in tracking and in the conformation of the reflective surface, optical figure of the reflective surface, insolation, angular distribution of incoming sun rays to account for limb darkening and scattering, attenuation of light between the mirrors and the receiver, reflectivity of the mirror surface, and mirror aiming strategy.

Randomized comparison of reduced fat and reduced carbohydrate hypocaloric diets on intrahepatic fat in overweight and obese human subjects.

Science.gov (United States)

Haufe, Sven; Engeli, Stefan; Kast, Petra; Böhnke, Jana; Utz, Wolfgang; Haas, Verena; Hermsdorf, Mario; Mähler, Anja; Wiesner, Susanne; Birkenfeld, Andreas L; Sell, Henrike; Otto, Christoph; Mehling, Heidrun; Luft, Friedrich C; Eckel, Juergen; Schulz-Menger, Jeanette; Boschmann, Michael; Jordan, Jens

2011-05-01

Obesity-related hepatic steatosis is a major risk factor for metabolic and cardiovascular disease. Fat reduced hypocaloric diets are able to relieve the liver from ectopically stored lipids. We hypothesized that the widely used low carbohydrate hypocaloric diets are similarly effective in this regard. A total of 170 overweight and obese, otherwise healthy subjects were randomized to either reduced carbohydrate (n = 84) or reduced fat (n = 86), total energy restricted diet (-30% of energy intake before diet) for 6 months. Body composition was estimated by bioimpedance analyses and abdominal fat distribution by magnetic resonance tomography. Subjects were also submitted to fat spectroscopy of liver and oral glucose tolerance testing. In all, 102 subjects completed the diet intervention with measurements of intrahepatic lipid content. Both hypocaloric diets decreased body weight, total body fat, visceral fat, and intrahepatic lipid content. Subjects with high baseline intrahepatic lipids (>5.56%) lost ≈7-fold more intrahepatic lipids compared with those with low baseline values (diet composition. In contrast, changes in visceral fat mass and insulin sensitivity were similar between subgroups, with low and high baseline intrahepatic lipids. A prolonged hypocaloric diet low in carbohydrates and high in fat has the same beneficial effects on intrahepatic lipid accumulation as the traditional low-fat hypocaloric diet. The decrease in intrahepatic lipids appears to be independent of visceral fat loss and is not tightly coupled with changes in whole body insulin sensitivity during 6 months of an energy restricted diet. Copyright © 2011 American Association for the Study of Liver Diseases.

Prenatal emotion management improves obstetric outcomes: a randomized control study.

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Huang, Jian; Li, He-Jiang; Wang, Jue; Mao, Hong-Jing; Jiang, Wen-Ying; Zhou, Hong; Chen, Shu-Lin

2015-01-01

Negative emotions can cause a number of prenatal problems and disturb obstetric outcomes. We determined the effectiveness of prenatal emotional management on obstetric outcomes in nulliparas. All participants completed the PHQ-9 at the baseline assessment. Then, the participants were randomly assigned to the emotional management (EM) and usual care (UC) groups. The baseline evaluation began at 31 weeks gestation and the participants were followed up to 42 days postpartum. Each subject in the EM group received an extra EM program while the participants in the UC groups received routine prenatal care and education only. The PHQ-9 and Edinburgh Postnatal Depression scale (EPDS) were used for assessment. The EM group had a lower PHQ-9 score at 36 weeks gestation, and 7 and 42 days after delivery (P Prenatal EM intervention could control anxiety and depressive feelings in nulliparas, and improve obstetric outcomes. It may serve as an innovative approach to reduce the cesarean section rate in China.

Regular consumption of vitamin D-fortified yogurt drink (Doogh improved endothelial biomarkers in subjects with type 2 diabetes: a randomized double-blind clinical trial

Directory of Open Access Journals (Sweden)

Shab-Bidar Sakineh

2011-11-01

Full Text Available Abstract Background Endothelial dysfunction has been proposed as the underlying cause of diabetic angiopathy that eventually leads to cardiovascular disease, the major cause of death in diabetes. We recently demonstrated the ameliorating effect of regular vitamin D intake on the glycemic status of patients with type 2 diabetes (T2D. In this study, the effects of improvement of vitamin D status on glycemic status, lipid profile and endothelial biomarkers in T2D subjects were investigated. Methods Subjects with T2D were randomly allocated to one of the two groups to receive either plain yogurt drink (PYD; containing 170 mg calcium and no vitamin D/250 mL, n1 = 50 or vitamin D3-fortified yogurt drink (FYD; containing 170 mg calcium and 500 IU/250 mL, n2 = 50 twice a day for 12 weeks. Anthropometric measures, glycemic status, lipid profile, body fat mass (FM and endothelial biomarkers including serum endothelin-1, E-selectin and matrix metalloproteinase (MMP-9 were evaluated at the beginning and after the 12-week intervention period. Results The intervention resulted in a significant improvement in fasting glucose, the Quantitative Insulin Check Index (QUICKI, glycated hemoglobin (HbA1c, triacylglycerols, high-density lipoprotein cholesterol (HDL-C, endothelin-1, E-selectin and MMP-9 in FYD compared to PYD (P P = 0.028; -3.8 ± 7.3 versus 0.95 ± 8.3, P = 0.003 and -2.3 ± 3.7 versus 0.44 ± 7.1 ng/mL, respectively, P P = 0.009 and P = 0.005, respectively but disappeared for E-selectin (P = 0.092. On the contrary, after controlling for serum 25(OHD, the differences disappeared for endothelin-1(P = 0.066 and MMP-9 (P = 0.277 but still remained significant for E-selectin (P = 0.011. Conclusions Ameliorated vitamin D status was accompanied by improved glycemic status, lipid profile and endothelial biomarkers in T2D subjects. Our findings suggest both direct and indirect ameliorating effects of vitamin D on the endothelial biomarkers. Trial registration

Full-mouth disinfection as a therapeutic protocol for type-2 diabetic subjects with chronic periodontitis: twelve-month clinical outcomes: a randomized controlled clinical trial.

Science.gov (United States)

Santos, Vanessa R; Lima, Jadson A; Miranda, Tamires S; Gonçalves, Tiago E D; Figueiredo, Luciene C; Faveri, Marcelo; Duarte, Poliana M

2013-02-01

The aim of this randomized controlled clinical trial was to evaluate the clinical effects of chlorhexidine (CHX) application in a full-mouth disinfection (FMD) protocol in poorly controlled type-2 diabetic subjects with generalized chronic periodontitis. Thirty-eight subjects were randomly assigned into FMD group (n=19): full-mouth scaling and root planing (FMSRP) within 24 h + local application of CHX gel + CHX rinses for 60 days or Control group (n = 19): FMSRP within 24 h + local application of placebo gel + placebo rinses for 60 days. Clinical parameters, glycated haemoglobin and fasting plasma glucose were assessed at baseline, 3, 6 and 12 months post-therapies. All clinical parameters improved significantly at 3, 6 and 12 months post-therapies for both groups (p clinical parameters, and glycemic condition at any time-point (p > 0.05). The treatments did not differ with respect to clinical parameters, including the primary outcome variable (i.e. changes in clinical attachment level in deep pockets), for up to 12 months post-treatments. © 2012 John Wiley & Sons A/S.

Effect of an Empowerment Program on Self-Efficacy of Epileptic Child's Mothers in Psychological Adaptation, Gaining Support and Receiving Information

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S. Gholami

2016-09-01

Full Text Available Aims: Epilepsy is one of the most prevalent childhood neurological disorders. As the primary caregivers, the mothers of epileptic children undergo different psychological pressures. The aim of the study was to investigate the effects of empowerment on the self-efficacy of the mothers of the epileptic children, concerning psychological adaptation, gaining support, and receiving information. Materials & Methods: In the controlled two-group random clinical trial with pretest and posttest steps, 100 mothers of epileptic children hospitalized in the Neurology Ward of Ghaem Hospital of Mashhad were studied in 2014. The subjects, selected via convenience sampling method, were randomly divided into two groups including experimental (n=50 and control (n=50 groups. Data was collected using the caregiver’s self-efficacy questionnaire. Only experimental group received the empowerment program, and no intervention was conducted in control group. The mothers’ self-efficacy was measured before and after the intervention in both groups. Data was analyzed by SPSS 11.5 software using independent T, paired T, Chi-square, Fisher’s exact, and covariance tests. Findings: The mean scores of self-efficacy, including psychological adjustment, gain a support, and receiving information, were not significantly different between the groups before the intervention (p>0.05. Nevertheless, the groups were significantly different after the intervention (p<0.001. In addition, the mean score after the intervention in experimental group was significantly higher than the score in the same group before the intervention (p<0.001. Conclusion: The empowerment program enhances the self-efficacy of the mothers of the epileptic children in psychological adjustment, gain a support, and receiving information.

Dolutegravir versus placebo in subjects harbouring HIV-1 with integrase inhibitor resistance associated substitutions: 48-week results from VIKING-4, a randomized study.

Science.gov (United States)

Akil, Bisher; Blick, Gary; Hagins, Debbie P; Ramgopal, Moti N; Richmond, Gary J; Samuel, Rafik M; Givens, Naomi; Vavro, Cindy; Song, Ivy H; Wynne, Brian; Ait-Khaled, Mounir

2015-01-01

The Phase III VIKING-3 study demonstrated that dolutegravir (DTG) 50 mg twice daily was efficacious in antiretroviral therapy (ART)-experienced subjects harbouring raltegravir- and/or elvitegravir-resistant HIV-1. VIKING-4 (ING116529) included a placebo-controlled 7-day monotherapy phase to demonstrate that short-term antiviral activity was attributable to DTG. VIKING-4 is a Phase III randomized, double-blind study in therapy-experienced adults with integrase inhibitor (INI)-resistant virus randomized to DTG 50 mg twice daily or placebo while continuing their failing regimen (without raltegravir or elvitegravir) for 7 days (clinicaltrials.gov identifier NCT01568892). At day 8, all subjects switched to open-label DTG 50 mg twice daily and optimized background therapy including ≥1 fully active drug. The primary end point was change from baseline in plasma HIV-1 RNA at day 8. The study population (n=30) was highly ART-experienced with advanced HIV disease. Patients had extensive baseline resistance to all approved antiretroviral classes. Adjusted mean change in HIV-1 RNA at day 8 was 
-1.06 log10 copies/ml for the DTG arm and 0.10 log10 copies/ml for the placebo arm (treatment difference -1.16 log10 copies/ml [-1.52, -0.80]; PVIKING-3 study.

Random glucose is useful for individual prediction of type 2 diabetes: results of the Study of Health in Pomerania (SHIP).

Science.gov (United States)

Kowall, Bernd; Rathmann, Wolfgang; Giani, Guido; Schipf, Sabine; Baumeister, Sebastian; Wallaschofski, Henri; Nauck, Matthias; Völzke, Henry

2013-04-01

Random glucose is widely used in routine clinical practice. We investigated whether this non-standardized glycemic measure is useful for individual diabetes prediction. The Study of Health in Pomerania (SHIP), a population-based cohort study in north-east Germany, included 3107 diabetes-free persons aged 31-81 years at baseline in 1997-2001. 2475 persons participated at 5-year follow-up and gave self-reports of incident diabetes. For the total sample and for subjects aged ≥50 years, statistical properties of prediction models with and without random glucose were compared. A basic model (including age, sex, diabetes of parents, hypertension and waist circumference) and a comprehensive model (additionally including various lifestyle variables and blood parameters, but not HbA1c) performed statistically significantly better after adding random glucose (e.g., the area under the receiver-operating curve (AROC) increased from 0.824 to 0.856 after adding random glucose to the comprehensive model in the total sample). Likewise, adding random glucose to prediction models which included HbA1c led to significant improvements of predictive ability (e.g., for subjects ≥50 years, AROC increased from 0.824 to 0.849 after adding random glucose to the comprehensive model+HbA1c). Random glucose is useful for individual diabetes prediction, and improves prediction models including HbA1c. Copyright © 2012 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

Rilonacept in the treatment of subacromial bursitis: A randomized, non-inferiority, unblinded study versus triamcinolone acetonide.

Science.gov (United States)

Carroll, Matthew B; Motley, Spencer A; Wohlford, Susanna; Ramsey, Bryan C

2015-12-01

Subacromial bursitis is caused by inflammation of the bursa that separates the superior surface of the supraspinatus tendon from the overlying coraco-acromial ligament and acromion. While multiple cytokines are implicated, interleukin-1 beta appears to play a prominent role. Rilonacept, an interleukin-1 trap, may be an alternative to corticosteroid injection for the management of this condition. This single center, randomized, non-inferiority, unblinded study recruited 33 subjects over 9 months. Twenty subjects received 160mg intrabursal injection of rilonacept and 13 received a 6mL mixture of lidocaine, bupivacaine, and 80mg triamcinolone acetonide. QuickDASH, subject reported pain, and adverse events were recorded at time of injection, 2 days later, 2 weeks later, and 4 weeks later. Primary outcome was improvement in QuickDASH 4 weeks post-injection. Secondary outcomes were improvement in subject reported pain and occurrence of adverse events at 4 weeks. Both study groups were equally matched for age, gender, ethnicity, and site of bursa injection. Both medications demonstrated a statistically significant improvement in QuickDASH 4 weeks post-injection, but triamcinolone acetonide injection offered greater improvement (P=0.004). Both medications demonstrated improvement in subject reported pain but between group comparison at 4 weeks showed that triamcinolone was superior (P=0.044). No statistically significant differences in adverse events were noted between groups, but subjects who received rilonacept experienced more episodes of diarrhea and headache. While improvement in QuickDASH and pain was noted with a single intrabursal injection of rilonacept at 4 weeks, injection with triamcinolone acetonide was more efficacious. This trial was registered with www.clinicaltrials.gov (NCT01830699). Copyright © 2015 Société française de rhumatologie. Published by Elsevier SAS. All rights reserved.

Effect of Low-Dose (Single-Dose Magnesium Sulfate on Postoperative Analgesia in Hysterectomy Patients Receiving Balanced General Anesthesia

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Arman Taheri

2015-01-01

Full Text Available Background and Aim. Aparallel, randomized, double blinded, placebo-controlled trial study was designed to assess the efficacy of single low dose of intravenous magnesium sulfate on post-total abdominal hysterectomy (TAH pain relief under balanced general anesthesia. Subject and Methods. Forty women undergoing TAH surgery were assigned to two magnesium sulfate (N=20 and normal saline (N=20 groups randomly. The magnesium group received magnesium sulfate 50 mg·kg−1 in 100 mL of normal saline solution i.v as single-dose, just 15 minutes before induction of anesthesia whereas patients in control group received 100 mL of 0.9% sodium chloride solution at the same time. The same balanced general anesthesia was induced for two groups. Pethidine consumption was recorded over 24 hours precisely as postoperative analgesic. Pain score was evaluated with Numeric Rating Scale (NRS at 0, 6, 12, and 24 hours after the surgeries. Results. Postoperative pain score was lower in magnesium group at 6, 12, and 24 hours after the operations significantly (P<0.05. Pethidine requirement was significantly lower in magnesium group throughout 24 hours after the surgeries (P=0.0001. Conclusion. Single dose of magnesium sulfate during balanced general anesthesia could be considered as effective and safe method to reduce postoperative pain and opioid consumption after TAH.

Effectiveness of a lifestyle exercise program for older people receiving a restorative home care service: a pragmatic randomized controlled trial.

Science.gov (United States)

Burton, Elissa; Lewin, Gill; Clemson, Lindy; Boldy, Duncan

2013-01-01

Restorative home care services are short-term and aimed at maximizing a person's ability to live independently. They are multidimensional and often include an exercise program to improve strength, mobility, and balance. The aim of this study was to determine whether a lifestyle exercise program would be undertaken more often and result in greater functional gains than the current structured exercise program delivered as part of a restorative home care service for older adults. A pragmatic randomized controlled trial was conducted in an organization with an established restorative home care service. Individuals who were to have an exercise program as part of their service were randomized to receive either a lifestyle and functional exercise program called LiFE (as this was a new program, the intervention) or the structured exercise program currently being used in the service (control). Exercise data collected by the individuals throughout and pre and post intervention testing was used to measure balance, strength, mobility, falls efficacy, vitality, function, and disability. There was no difference between the groups in the amounts of exercise undertaken during the 8-week intervention period. Outcome measurement indicated that the LiFE program was as effective, and on 40% of the measures, more effective, than the structured exercise program. Organizations delivering restorative home care services that include an exercise component should consider whether LiFE rather than the exercise program they are currently using could help their clients achieve better outcomes.

Improved healing response in delayed unions of the tibia with low-intensity pulsed ultrasound: results of a randomized sham-controlled trial

Directory of Open Access Journals (Sweden)

Aigner Julia

2010-10-01

Full Text Available Abstract Background We compared the healing response of tibial delayed unions between subjects treated with low-intensity pulsed ultrasound (LIPUS (n = 51 and subjects treated with a sham device (n = 50. Fracture age was ≥ 4 months in all cases. Study personnel and participants were blinded to random treatment assignment throughout the study. Methods This multi-center randomized sham-controlled trial was undertaken at six hospitals in Germany. Adult patients who had sustained a tibial shaft fracture that subsequently showed inadequate progress toward healing (i.e., delayed union were enrolled and randomized to receive either LIPUS (Exogen 2000/2000+, Smith & Nephew GmbH, Schenefeld, Germany or an identical nonoperative sham device. The daily treatment duration was 20 minutes, for a period of 16 weeks. Subjects randomly assigned to active treatment had the ultrasound pressure wave signal set at the following parameters: 1.5 MHz frequency, 1 kHz repetition rate, 200 μs pulse duration, 30 mW/cm2 spatial intensity. Progress toward healing was estimated from changes in bone mineral density (BMD and gap area as determined from computed tomography scans. Intention-to-treat analysis was conducted using a multiple imputation methodology. Results Based on log-transformed data, mean improvement in BMD was 1.34 (90% confidence interval (CI 1.14 to 1.57 times greater for LIPUS-treated subjects compared to sham (p = 0.002. A mean reduction in bone gap area also favored LIPUS treatment (p = 0.014. Conclusions These findings demonstrate significantly greater progress toward bone healing after LIPUS treatment compared to no LIPUS treatment in subjects with established delayed unions of the tibia.

Efficacy of aprepitant for the prevention of chemotherapy-induced nausea and vomiting with a moderately emetogenic chemotherapy regimen: a multicenter, placebo-controlled, double-blind, randomized study in patients with gynecologic cancer receiving paclitaxel and carboplatin.

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Yahata, Hideaki; Kobayashi, Hiroaki; Sonoda, Kenzo; Shimokawa, Mototsugu; Ohgami, Tatsuhiro; Saito, Toshiaki; Ogawa, Shinji; Sakai, Kunihiro; Ichinoe, Akimasa; Ueoka, Yousuke; Hasuo, Yasuyuki; Nishida, Makoto; Masuda, Satohiro; Kato, Kiyoko

2016-06-01

Substance P contributes to the hypersensitivity reaction (HSR) to paclitaxel in a rat model. Aprepitant acts as an inhibitor of the binding of substance P to the neurokinin-1 receptor and, consequently, may reduce the frequency of paclitaxel-induced HSR. While aprepitant has a prophylactic effect against vomiting caused by high-dose cisplatin, the benefits of aprepitant have not been clearly demonstrated in patients receiving paclitaxel and carboplatin (TC) combination chemotherapy. We conducted a multicenter, placebo-controlled, double-blind, randomized study in Japanese patients with gynecologic cancer who received TC combination chemotherapy. Patients received aprepitant or placebo together with both a 5-HT3 receptor antagonist and dexamethasone prior to chemotherapy. The primary endpoint was the proportion of patients with HSR, and the secondary endpoints were the proportion of patients with "no vomiting", "no significant nausea", and complete response, respectively. Of the 324 randomized patients, 297 (151 in the aprepitant group; 146 in the placebo group) were evaluated. The percentage of patients with HSR (9.2 vs. 7.5 %, respectively; P = 0.339) was not significantly different between the groups. The percentage of "no vomiting" patients (78.2 vs. 54.8 %; P gynecologic cancer patients receiving TC combination chemotherapy.

Random walk of passive tracers among randomly moving obstacles.

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Gori, Matteo; Donato, Irene; Floriani, Elena; Nardecchia, Ilaria; Pettini, Marco

2016-04-14

This study is mainly motivated by the need of understanding how the diffusion behavior of a biomolecule (or even of a larger object) is affected by other moving macromolecules, organelles, and so on, inside a living cell, whence the possibility of understanding whether or not a randomly walking biomolecule is also subject to a long-range force field driving it to its target. By means of the Continuous Time Random Walk (CTRW) technique the topic of random walk in random environment is here considered in the case of a passively diffusing particle among randomly moving and interacting obstacles. The relevant physical quantity which is worked out is the diffusion coefficient of the passive tracer which is computed as a function of the average inter-obstacles distance. The results reported here suggest that if a biomolecule, let us call it a test molecule, moves towards its target in the presence of other independently interacting molecules, its motion can be considerably slowed down.

Intense pulsed light, near infrared pulsed light, and fractional laser combination therapy for skin rejuvenation in Asian subjects: a prospective multi-center study in China.

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Tao, Li; Wu, Jiaqiang; Qian, Hui; Lu, Zhong; Li, Yuanhong; Wang, Weizhen; Zhao, Xiaozhong; Tu, Ping; Yin, Rui; Xiang, Leihong

2015-09-01

Ablative skin rejuvenation therapies have limitations for Asian people, including post-inflammatory hyperpigmentation and long down time. Non-ablative lasers are safer but have limited efficacy. This study is to investigate the safety and efficacy of a combination therapy consisting of intense pulsed light (IPL), near infrared (NIR) light, and fractional erbium YAG (Er:YAG) laser for skin rejuvenation in Asian people. This study recruited 113 subjects from six sites in China. Subjects were randomly assigned to a full-face group, who received combination therapy, and split-face groups, in which one half of the face received combination therapy and the other half received IPL monotherapy. Each subject received five treatment sessions during a period of 90 days. Subjects were followed up at 1 and 3 months post last treatment. Three months after last treatment, the full-face group (n = 57) had a global improvement rate of 29 % and 29 % for wrinkles, 32 % for skin texture, 33 % for pigment spots, 28 % for pore size, respectively. For patients in the split-face groups (n = 54), monotherapy side had a global improvement rate of 23 % and 20 % for wrinkles, 27 % for skin texture, 25 % for pigment spots, 25 % for pore size, respectively. Both combination therapy and monotherapy resulted in significant improvements at the follow-up visits compared to baseline (P < 0.001). Combination therapy showed significantly greater improvements compared to monotherapy at two follow-up visits (P < 0.05). Combination therapy is a safe and more effective strategy than IPL monotherapy for skin rejuvenation in Asian people.

Does clinical equipoise apply to cluster randomized trials in health research?

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2011-01-01

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, Weijer and colleagues set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the third of the questions posed, namely, does clinical equipoise apply to CRTs in health research? The ethical principle of beneficence is the moral obligation not to harm needlessly and, when possible, to promote the welfare of research subjects. Two related ethical problems have been discussed in the CRT literature. First, are control groups that receive only usual care unduly disadvantaged? Second, when accumulating data suggests the superiority of one intervention in a trial, is there an ethical obligation to act? In individually randomized trials involving patients, similar questions are addressed by the concept of clinical equipoise, that is, the ethical requirement that, at the start of a trial, there be a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. Since CRTs may not involve physician-researchers and patient-subjects, the applicability of clinical equipoise to CRTs is uncertain. Here we argue that clinical equipoise may be usefully grounded in a trust relationship between the state and research subjects, and, as a result, clinical equipoise is applicable to CRTs. Clinical equipoise is used to argue that control groups receiving only usual care are not disadvantaged so long as the evidence supporting the experimental and control interventions is such that experts would disagree as to which is preferred. Further, while data accumulating during the course of a CRT may favor one intervention over another, clinical equipoise supports continuing the trial until the results are likely to be broadly convincing, often coinciding with the planned completion of the trial

Transcranial Magnetic Stimulation in the Treatment of Chronic Widespread Pain: A Randomized, Controlled Study

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Avery, David H.; Zarkowski, Paul; Krashin, Daniel; Rho, Wang-ku; Wajdik, Chandra; Joesch, Jutta M.; Haynor, David R.; Buchwald, Dedra; Roy-Byrne, Peter

2014-01-01

Objective Our objective was to assess transcranial magnetic stimulation (TMS) in the treatment of chronic widespread pain (CWP). Methods Nineteen participants were randomized to two groups: one receiving active TMS (N=7) and another receiving sham stimulation (N=11) applied to the left dorsolateral prefrontal cortex. During sham stimulation, subjects heard a sound similar to the sound heard by those receiving the active treatment and received an active electrical stimulus to the scalp. The stimulation protocol consisted of 15 sessions completed within a 4-week period. Blind assessments were done at baseline and after each 5 sessions followed by blind assessments at 1 week, 1 month and 3 months after the last TMS sessions. The primary outcome variable was a pain measure, the Gracely Box Intensity Scale (BIRS). Results The percentage of subjects who guessed that they were receiving TMS was similar in the two groups. Both the TMS group and the sham group showed a statistically significant reduction in the BIRS scores from baseline during the acute phase of treatment and the follow-up phase. However, the TMS and sham groups did not differ in the change in the BIRS scores. Discussion Although some previous clinical studies and basic science studies of TMS in treating pain are promising, this study found no difference in the analgesic effect of TMS and sham stimulation. Future studies should utilize a sham condition that attempts to simulate the sound and sensation of the TMS stimulation. Stimulus location and other stimulus parameters should be explored in future studies. PMID:24755729

Transcranial magnetic stimulation in the treatment of chronic widespread pain: a randomized controlled study.

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Avery, David H; Zarkowski, Paul; Krashin, Daniel; Rho, Wang-Ku; Wajdik, Chandra; Joesch, Jutta M; Haynor, David R; Buchwald, Dedra; Roy-Byrne, Peter

2015-03-01

Our objective was to assess transcranial magnetic stimulation (TMS) in the treatment of chronic widespread pain. Nineteen participants were randomized into 2 groups: one group receiving active TMS (n = 7) and another group receiving sham stimulation (n = 11) applied to the left dorsolateral prefrontal cortex. During sham stimulation, subjects heard a sound similar to the sound heard by those receiving the active treatment and received an active electrical stimulus to the scalp. The stimulation protocol consisted of 15 sessions completed within a 4-week period. Blind assessments were done at baseline and after each 5 sessions followed by blind assessments at 1 week, 1 month, and 3 months after the last TMS sessions. The primary outcome variable was a pain measure, the Gracely Box Intensity Scale (BIRS). The percentage of subjects who guessed that they were receiving TMS was similar in the 2 groups. Both the TMS group and the sham group showed a statistically significant reduction in the BIRS scores from baseline during the acute phase of treatment and the follow-up phase. However, the TMS and sham groups did not differ in the change in the BIRS scores. Although some previous clinical studies and basic science studies of TMS in treating pain are promising, this study found no difference in the analgesic effect of TMS and sham stimulation. Future studies should use a sham condition that attempts to simulate the sound and sensation of the TMS stimulation. Stimulus location and other stimulus parameters should be explored in future studies.

A randomized controlled trial: the effect of inulin on weight management and ectopic fat in subjects with prediabetes.

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Guess, Nicola D; Dornhorst, Anne; Oliver, Nick; Bell, Jimmy D; Thomas, E Louise; Frost, Gary S

2015-01-01

Fat infiltration of the liver, muscle and pancreas is associated with insulin resistance and risk of diabetes. Weight loss reduces ectopic fat deposition and risk of diabetes, but is difficult to sustain to due to compensatory increases in appetite. Fermentable carbohydrates have been shown to decrease appetite and food intake, and promote weight loss in overweight subjects. In animal studies, fermentable carbohydrate reduces ectopic fat independent of weight loss. We aimed to investigate the effect of the fermentable carbohydrate inulin on weight maintenance, appetite and ectopic fat in subjects with prediabetes. Forty-four subjects with prediabetes were randomized to 18 weeks' inulin or cellulose supplementation. During weeks 1-9 (weight loss phase) all subjects had four visits with a dietitian to guide them towards a 5 % weight loss. During weeks 10-18 (weight maintenance phase) subjects continued taking their assigned supplementation and were asked to maintain the weight they had lost but were offered no further support. All subjects attended study sessions at baseline, 9 and 18 weeks for measurement of weight; assessment of adipose tissue and ectopic fat content by magnetic resonance imaging and magnetic resonance spectroscopy; glucose, insulin and GLP-1 levels following a meal tolerance test; and appetite by ad libitum meal test and visual analogue scales. Both groups lost approximately 5 % of their body weight by week nine (-5.3 ± 0.1 % vs -4.3 ± 0.4 %, p = 0.13, but the inulin group lost significantly more weight between 9 and 18 weeks (-2.3 ± 0.5 % vs -0.6 ± 0.4 %, p = 0.012). Subjects taking inulin had lower hepatic (p = 0.02) and soleus muscle (p fat content at 18 weeks compared to control even after controlling for weight loss and consumed less at the ad libitum meal test (p = 0.027). Fasting glucose significantly decreased at week nine only (p = 0.005), insulin concentrations did not change, and there

Subjective, behavioral, and physiological effects of acute caffeine in light, nondependent caffeine users.

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Childs, Emma; de Wit, Harriet

2006-05-01

Caffeine produces mild psychostimulant effects that are thought to underlie its widespread use. However, the direct effects of caffeine are difficult to evaluate in regular users of caffeine because of tolerance and withdrawal. Indeed, some researchers hypothesize that the psychostimulant effects of caffeine are due largely to the reversal of withdrawal and question whether there are direct effects of caffeine consumption upon mood, alertness, or mental performance in nondependent individuals. This study investigated the physiological, subjective, and behavioral effects of 0, 50, 150, and 450 mg caffeine in 102 light, nondependent caffeine users. Using a within-subjects design, subjects participated in four experimental sessions, in which they received each of the four drug conditions in random order under double blind conditions. Participants completed subjective effects questionnaires and vital signs were measured before and at repeated time points after drug administration. Forty minutes after the capsules were ingested, subjects completed behavioral tasks that included tests of sustained attention, short-term memory, psychomotor performance, and behavioral inhibition. Caffeine significantly increased blood pressure, and produced feelings of arousal, positive mood, and high. Caffeine increased the number of hits and decreased reaction times in a vigilance task, but impaired performance on a memory task. We confirm that acute doses of caffeine, at levels typically found in a cup of coffee, produce stimulant-like subjective effects and enhance performance in light, nondependent caffeine users. These findings support the idea that the drug has psychoactive effects even in the absence of withdrawal.

Spinal mobilization vs conventional physiotherapy in the management of chronic low back pain due to spinal disk degeneration: a randomized controlled trial.

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Krekoukias, Georgios; Gelalis, Ioannis D; Xenakis, Theodoros; Gioftsos, Georgios; Dimitriadis, Zacharias; Sakellari, Vasiliki

2017-05-01

The aim of the study was to examine the efficacy of spinal mobilization in subjects with low back pain (LBP) and associated spinal disk degeneration. Seventy-five subjects suffering from chronic LBP (>3 months) were randomly allocated into 3 groups of 25 subjects each. Each group received five treatment sessions with the first group receiving manual therapy (MT) (spinal mobilization), the second a sham treatment, and the third conventional physiotherapy (CP) (stretching exercises, transcutaneous electrical nerve stimulation, and massage). Subjects were assessed for their pain intensity using the numerical pain rating scale and for their self-reported disability using the Oswestry and Roland-Morris Questionnaire at baseline and after the completion of the five treatment sessions. Paired t -tests showed a significant improvement for all outcome measures in the MT and CP group ( p   0.05). MT is preferable to CP in order to reduce the pain intensity and disability in subjects with chronic LBP and associated disk degeneration. The findings of this study may lead to the establishment of spinal mobilization as one of the most preferable approaches for the management of LBP due to disk degeneration. 1b.

Polyethylene glycol 3350 in occasional constipation: A one-week, randomized, placebo-controlled, double-blind trial.

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McGraw, Thomas

2016-05-06

To evaluate the efficacy and safety of polyethylene glycol (PEG) 3350 in subjects with self-reported occasional constipation. Eligible subjects ≥ 17 years of age were randomized to receive either placebo or PEG 3350 17 g once daily in this multicenter, double-blind trial. Evaluations were conducted before (baseline) and after a 7-d treatment period. The primary efficacy variable was the proportion of subjects reporting complete resolution of straining and hard or lumpy stools. Secondary efficacy variables assessed the severity of the subjects' daily bowel movement (BM) symptoms, and preference of laxatives based on diary entries, visual analog scale scores, and questionnaires. Of the 203 subjects enrolled in the study, 11 had major protocol violations. Complete resolution was noted by 36/98 (36.7%) subjects in the PEG 3350 group and 23/94 (24.5%) in the placebo group (P = 0.0595). The number of complete BMs without straining or lumpy stools was similar between both groups. Subjects receiving PEG 3350 experienced significant relief in straining and reduction in hardness of stools over a 7-d period (P PEG 3350 had a better effect on their daily lives, provided better control over a BM, better relief from constipation, cramping, and bloating, and was their preferred laxative. Adverse events (AEs) were balanced between the PEG 3350 and the placebo groups. No deaths, serious AEs, or discontinuations due to AEs were reported. This trial is registered at clinicaltrials.gov as NCT00770432. Oral administration of 17 g PEG 3350 once daily for a week is effective, safe, and well tolerated in subjects with occasional constipation.

Different antibiotic protocols in the treatment of severe chronic periodontitis: A 1-year randomized trial.

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Borges, Ivan; Faveri, Marcelo; Figueiredo, Luciene Cristina; Duarte, Poliana Mendes; Retamal-Valdes, Belén; Montenegro, Sheyla Christinne Lira; Feres, Magda

2017-08-01

To evaluate the clinical effects of different dosages of metronidazole (MTZ) and durations of MTZ + amoxicillin (AMX) in the treatment of generalized chronic periodontitis (GChP). Subjects with severe GChP were randomly assigned to receive scaling and root planing (SRP)-only, or combined with 250 or 400 mg of MTZ + AMX (500 mg) thrice a day (TID), for 7 or 14 days. Subjects were monitored for 1 year. One hundred and nine subjects were enrolled. At 1 year, 61.9% and 63.6% of the subjects receiving AMX + 250 or 400 mg of MTZ for 14 days, respectively, reached the clinical endpoint for treatment (≤4 sites with probing depth ≥5 mm), against 31.8% of those taking 250 or 400 mg of MTZ for 7 days (p  .05). The adjunctive use of 400 or 250 mg of MTZ plus 500 mg of AMX/TID/14 days offers statistically significant and clinically relevant benefits over those achieved with SRP alone in the treatment of severe GChP. The added benefits of the 7-days regimen in this population were less evident. (ClinicalTrials.gov NCT02735395). © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A Triple-Masked, Randomized Controlled Trial Comparing Ultrasound-Guided Brachial Plexus and Distal Peripheral Nerve Block Anesthesia for Outpatient Hand Surgery

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Nicholas C. K. Lam

2014-01-01

Full Text Available Background. For hand surgery, brachial plexus blocks provide effective anesthesia but produce undesirable numbness. We hypothesized that distal peripheral nerve blocks will better preserve motor function while providing effective anesthesia. Methods. Adult subjects who were scheduled for elective ambulatory hand surgery under regional anesthesia and sedation were recruited and randomly assigned to receive ultrasound-guided supraclavicular brachial plexus block or distal block of the ulnar and median nerves. Each subject received 15 mL of 1.5% mepivacaine at the assigned location with 15 mL of normal saline injected in the alternate block location. The primary outcome (change in baseline grip strength measured by a hydraulic dynamometer was tested before the block and prior to discharge. Subject satisfaction data were collected the day after surgery. Results. Fourteen subjects were enrolled. Median (interquartile range [IQR] strength loss in the distal group was 21.4% (14.3, 47.8%, while all subjects in the supraclavicular group lost 100% of their preoperative strength, P = 0.001. Subjects in the distal group reported greater satisfaction with their block procedures on the day after surgery, P = 0.012. Conclusion. Distal nerve blocks better preserve motor function without negatively affecting quality of anesthesia, leading to increased patient satisfaction, when compared to brachial plexus block.

SMA CARNI-VAL trial part I: double-blind, randomized, placebo-controlled trial of L-carnitine and valproic acid in spinal muscular atrophy.

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Kathryn J Swoboda

2010-08-01

Full Text Available Valproic acid (VPA has demonstrated potential as a therapeutic candidate for spinal muscular atrophy (SMA in vitro and in vivo.Two cohorts of subjects were enrolled in the SMA CARNIVAL TRIAL, a non-ambulatory group of "sitters" (cohort 1 and an ambulatory group of "walkers" (cohort 2. Here, we present results for cohort 1: a multicenter phase II randomized double-blind intention-to-treat protocol in non-ambulatory SMA subjects 2-8 years of age. Sixty-one subjects were randomized 1:1 to placebo or treatment for the first six months; all received active treatment the subsequent six months. The primary outcome was change in the modified Hammersmith Functional Motor Scale (MHFMS score following six months of treatment. Secondary outcomes included safety and adverse event data, and change in MHFMS score for twelve versus six months of active treatment, body composition, quantitative SMN mRNA levels, maximum ulnar CMAP amplitudes, myometry and PFT measures.At 6 months, there was no difference in change from the baseline MHFMS score between treatment and placebo groups (difference = 0.643, 95% CI = -1.22-2.51. Adverse events occurred in >80% of subjects and were more common in the treatment group. Excessive weight gain was the most frequent drug-related adverse event, and increased fat mass was negatively related to change in MHFMS values (p = 0.0409. Post-hoc analysis found that children ages two to three years that received 12 months treatment, when adjusted for baseline weight, had significantly improved MHFMS scores (p = 0.03 compared to those who received placebo the first six months. A linear regression analysis limited to the influence of age demonstrates young age as a significant factor in improved MHFMS scores (p = 0.007.This study demonstrated no benefit from six months treatment with VPA and L-carnitine in a young non-ambulatory cohort of subjects with SMA. Weight gain, age and treatment duration were significant confounding variables that

Safety, pharmacokinetic, and functional effects of the nogo-a monoclonal antibody in amyotrophic lateral sclerosis: a randomized, first-in-human clinical trial.

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Vincent Meininger

Full Text Available The neurite outgrowth inhibitor, Nogo-A, has been shown to be overexpressed in skeletal muscle in amyotrophic lateral sclerosis (ALS; it is both a potential biomarker and therapeutic target. We performed a double-blind, two-part, dose-escalation study, in subjects with ALS, assessing safety, pharmacokinetics (PK and functional effects of ozanezumab, a humanized monoclonal antibody against Nogo-A. In Part 1, 40 subjects were randomized (3∶1 to receive single dose intravenous ozanezumab (0.01, 0.1, 1, 5, or 15 mg/kg or placebo. In Part 2, 36 subjects were randomized (3∶1 to receive two repeat doses of intravenous ozanezumab (0.5, 2.5, or 15 mg/kg or placebo, approximately 4 weeks apart. The primary endpoints were safety and tolerability (adverse events [AEs], vital signs, electrocardiogram (ECG, and clinical laboratory tests. Secondary endpoints included PK, immunogenicity, functional endpoints (clinical and electrophysiological, and biomarker parameters. Overall, ozanezumab treatment (0.01-15 mg/kg was well tolerated. The overall incidence of AEs in the repeat dose 2.5 mg/kg and 15 mg/kg ozanezumab groups was higher than in the repeat dose placebo group and repeat dose 0.5 mg/kg ozanezumab group. The majority were considered not related to study drug by the investigators. Six serious AEs were reported in three subjects receiving ozanezumab; none were considered related to study drug. No study drug-related patterns were identified for ECG, laboratory, or vital signs parameters. One subject (repeat dose 15 mg/kg ozanezumab showed a weak, positive anti-ozanezumab-antibody result. PK results were generally consistent with monoclonal antibody treatments. No apparent treatment effects were observed for functional endpoints or muscle biomarkers. Immunohistochemical staining showed dose-dependent co-localization of ozanezumab with Nogo-A in skeletal muscle. In conclusion, single and repeat dose ozanezumab treatment was well tolerated and demonstrated

The effectiveness of core stabilization exercise in adolescent idiopathic scoliosis: A randomized controlled trial.

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Gür, Gözde; Ayhan, Cigdem; Yakut, Yavuz

2017-06-01

Core stabilization training is used to improve postural balance in musculoskeletal problems. The purpose of this study was to investigate the effectiveness of stabilization training in adolescent idiopathic scoliosis. A randomized controlled trial, pretest-posttest design. In total, 25 subjects with adolescent idiopathic scoliosis were randomly divided into two groups: stabilization group ( n = 12) and control group ( n = 13). The stabilization group received core stabilization in addition to traditional rehabilitation, and the control group received traditional rehabilitation for 10 weeks. Assessment included Cobb's angle on radiograph, apical vertebral rotation in Adam's test, trunk asymmetry (Posterior Trunk Symmetry Index), cosmetic trunk deformity (Trunk Appearance Perception Scale), and quality of life (Scoliosis Research Society-22 questionnaire). Inter-group comparisons showed significantly greater improvements in the mean change in lumbar apical vertebral rotation degree and the pain domain of Scoliosis Research Society-22 in the stabilization group than those in the control group ( p adolescent idiopathic scoliosis. Clinical relevance Stabilization exercises are more effective in reducing rotation deformity and pain than traditional exercises in the conservative rehabilitation of adolescent idiopathic scoliosis. These improvements suggest that stabilization training should be added to rehabilitation programs in adolescent idiopathic scoliosis.

Pharmacokinetic comparison of sustained- and immediate-release oral formulations of cilostazol in healthy Korean subjects: a randomized, open-label, 3-part, sequential, 2-period, crossover, single-dose, food-effect, and multiple-dose study.

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Lee, Donghwan; Lim, Lay Ahyoung; Jang, Seong Bok; Lee, Yoon Jung; Chung, Jae Yong; Choi, Jong Rak; Kim, Kiyoon; Park, Jin Woo; Yoon, Hosang; Lee, Jaeyong; Park, Min Soo; Park, Kyungsoo

2011-12-01

A sustained-release (SR) formulation of cilostazol was recently developed in Korea and was expected to yield a lower C(max) and a similar AUC to the immediate-release (IR) formulation. The goal of the present study was to compare the pharmacokinetic profiles of a newly developed SR formulation and an IR formulation of cilostazol after single- and multiple-dose administration and to evaluate the influence of food in healthy Korean subjects. This study was developed as part of a product development project at the request of the Korean regulatory agency. This was a randomized, 3-part, sequential, open-label, 2-period crossover study. Each part consisted of different subjects between the ages of 19 and 55 years. In part 1, each subject received a single dose of SR (200 mg × 1 tablet, once daily) and IR (100 mg × 2 tablets, BID) formulations of cilostazol orally 7 days apart in a fasted state. In part 2, each subject received a single dose of the SR (200 mg × 1 tablet, once daily) formulation of cilostazol 7 days apart in a fasted and a fed state. In part 3, each subject received multiple doses of the 2 formulations for 8 consecutive days 21 days apart. Blood samples were taken for 72 hours after the dose. Cilostazol pharmacokinetics were determined for both the parent drug and its metabolites (OPC-13015 and OPC-13213). Adverse events were evaluated through interviews and physical examinations. Among the 92 enrolled subjects (66 men, 26 women; part 1, n = 26; part 2, n = 26; part 3, n = 40), 87 completed the study. In part 1, all the primary pharmacokinetic parameters satisfied the criterion for assumed bioequivalence both in cilostazol and its metabolites, yielding 90% CI ratios of 0.9624 to 1.2323, 0.8873 to 1.1208, and 0.8919 to 1.1283 for C(max) and 0.8370 to 1.0134, 0.8204 to 0.9807, and 0.8134 to 0.9699 for AUC(0-last) of cilostazol, OPC-13015, and OPC-13213, respectively. In part 2, food intake increased C(max) and AUC significantly (P food and 23 with a high

The effectiveness of fermented turmeric powder in subjects with elevated alanine transaminase levels: a randomised controlled study

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2013-01-01

Background Previous animal studies have shown that Curcuma longa (turmeric) improves liver function. Turmeric may thus be a promising ingredient in functional foods aimed at improving liver function. The purpose of the study is to investigate the hepatoprotective effect of fermented turmeric powder (FTP) on liver function in subjects with elevated alanine transaminase (ALT) levels. Methods A randomised, double-blind, placebo-controlled trial was conducted between November 2010 and April 2012 at the clinical trial center for functional foods of the Chonbuk National University Hospital. The trial included 60 subjects, 20 years old and above, who were diagnosed mild to moderate elevated ALT levels between 40 IU/L and 200 IU/L. Sixty subjects were randomised to receive FTP 3.0 g per day or placebo 3.0 g per day for 12 weeks. The treatment group received two capsules of FTP three times a day after meals, for 12 weeks. The primary efficacy endpoint was change in the ALT levels in the two groups. The secondary efficacy endpoints included its effect on aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), total bilirubin (TB), and lipid profiles. Safety was assessed throughout the study using ongoing laboratory tests. Adverse events (AEs) were also recorded. Results Sixty subjects were randomised in the study (30 into the FTP group, 30 into the placebo group), and among them, twelve subjects were excluded from the analysis for protocol violation, adverse events or consent withdrawal. The two groups did not differ in baseline characteristics. After 12 weeks of treatment, 48 subjects were evaluated. Of the 48 subjects, 26 randomly received FTP capsules and 22 received placebo. The FTP group showed a significant reduction in ALT levels after 12 weeks of treatment compared with the placebo group (p = 0.019). There was also observed that the serum AST levels were significantly reduce in the FTP group than placebo group (p = 0.02). The GGT levels

Study to assess the effectiveness of modified constraint-induced movement therapy in stroke subjects: A randomized controlled trial

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Priyanka Singh

2013-01-01

Full Text Available Background and Purpose: The purpose of this study was to assess the effectiveness of modified constraint induced movement therapy (m-CIMT in stroke subjects. Materials and Methods: A total of forty sub-acute stroke subjects were randomly assigned to either a m-CIMT (n = 20 or in a control group (n = 20. The m-CIMT group (14 men, 6 women; mean age = 55.2 years consisted of structured 2 h therapy sessions emphasizing affected arm use, occurring 5 times/week for 2 weeks. A mitt was used to restrain the unaffected arm for 10 h/day for 2 week. The control group (11 men, 9 women; mean age = 56.4 years consisted of conventional rehabilitation for time-matched exercise program. The outcome measures were evaluated at pre- and post-intervention by using the Wolf Motor Function Test (WMFT and Fugl-Meyer assessment (FMA of motor recovery after stroke. Results: After intervention significant effects were observed in m-CIMT group on WMFT (pre-test and post-test score was 28.04 ± 6.58, 13.59 ± 2.86; P =0.003. Similarly on FMA (pre- and post-test score was 31.15 ± 6.37, 55.7 ± 6.4; P = 0.00. Conclusion: There is a significant improvem ent in upper extremity function so it indicates that m-CIMT is effective in improving the motor function of the affected arm in stroke subjects. However, its long-term effect has not proved since there was no follow-up after intervention.

Random Decrement

DEFF Research Database (Denmark)

Asmussen, J.C.; Ibrahim, S.R.; Brincker, Rune

Abstraet Thispaper demansirates how to use the Random Decrement (RD) technique for identification o flinear structures subjected to ambient excitation. The theory behind the technique will be presented and guidelines how to choose the different variables will be given. This is done by introducing...

Efficacy and safety of a low-level laser device in the treatment of male and female pattern hair loss: a multicenter, randomized, sham device-controlled, double-blind study.

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Jimenez, Joaquin J; Wikramanayake, Tongyu C; Bergfeld, Wilma; Hordinsky, Maria; Hickman, Janet G; Hamblin, Michael R; Schachner, Lawrence A

2014-04-01

Male and female pattern hair loss are common, chronic dermatologic disorders with limited therapeutic options. In recent years, a number of commercial devices using low-level laser therapy have been promoted, but there have been little peer-reviewed data on their efficacy. To determine whether treatment with a low-level laser device, the US FDA-cleared HairMax Lasercomb®, increases terminal hair density in both men and women with pattern hair loss. Randomized, sham device-controlled, double-blind clinical trials were conducted at multiple institutional and private practices. A total of 146 male and 188 female subjects with pattern hair loss were screened. A total of 128 male and 141 female subjects were randomized to receive either a lasercomb (one of three models) or a sham device in concealed sealed packets, and were treated on the whole scalp three times a week for 26 weeks. Terminal hair density of the target area was evaluated at baseline and at 16- and 26-week follow-ups, and analyzed to determine whether the hypothesis formulated prior to data collection, that lasercomb treatment would increase terminal hair density, was correct. The site investigators and the subjects remained blinded to the type of device they dispensed/received throughout the study. The evaluator of masked digital photographs was blinded to which trial arm the subject belonged. Seventy-eight, 63, 49, and 79 subjects were randomized in four trials of 9-beam lasercomb treatment in female subjects, 12-beam lasercomb treatment in female subjects, 7-beam lasercomb treatment in male subjects, and 9- and 12-beam lasercomb treatment in male subjects, compared with the sham device, respectively. Nineteen female and 25 male subjects were lost to follow-up. Among the remaining 122 female and 103 male subjects in the efficacy analysis, the mean terminal hair count at 26 weeks increased from baseline by 20.2, 20.6, 18.4, 20.9, and 25.7 per cm2 in 9-beam lasercomb-treated female subjects, 12-beam

EFFECTIVENESS OF ROCABADO'S TECHNIQUE FOR SUBJECTS WITH TEMPOROMANDIBULAR JOINT DYSFUNCTION - A SINGLE BLIND STUDY

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Niha Siraj Mulla

2015-02-01

Full Text Available Background:A temporo-mandibular joint dysfunction or TMD is a group of conditions characterized by pain in the muscles of mastication, the temporo-mandiblar joint or both. Rocabado has described techniques includes the Rocabado’s manipulation and Rocabado’s exercises which have both been individually advocated for treatment of TMD. The purpose of study is to determine the effectiveness of Rocabado’s techniques on TMJ dysfunction symptoms, pain, TMJ Range of Motion (ROM and jaw functional limitation for subjects with temporo-mandibular joint dysfunction. Method: Pre to post test experimental study design, subjects with temporo-mandibular joint dysfunction randomized into two groups with 15 subjects into each group with total of 30 subjects in Study and control group, respectively. The study group received the Rocabado’s technique which consisted of Rocabado’s non-thrust TMJ manipulation and Rocabado’s exercises along with conventional TMJ exercises and the control group received only conventional TMJ exercises. The exercises were performed for 6 times per each session, six times in a day, one session under supervision and remaining five sessions by the subject at home for 6 days in a week for duration of 2 weeks. The outcome measurements such as VAS for pain, TMJ ROM, Fonseca’s questionnaire rating for TMJ dysfunction symptoms and jaw function limitation score (JFLS was measured before and after two weeks of intervention. Results: Comparative analysis, using Independent ‘t’ test and Mann Whitney U- test found that the means of VAS, TMJ ROM, Fonseca’s questionnaire and JFLS scores showed statistically significant difference (p <0.05 when the pre-intervention means and post-intervention means were compared between two groups. Conclusion: It is concluded that Rocabado’s technique found to have statistically and clinically significant added effect with conventional TMJ exercises shown greater percentage of improvements obtained

Influence of the Lactotripeptides Isoleucine-Proline-Proline and Valine-Proline-Proline on Systolic Blood Pressure in Japanese Subjects: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

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Aurelie Chanson-Rolle

Full Text Available The lactotripeptides isoleucine-proline-proline (IPP and valine-proline-proline (VPP have been shown to decrease systolic blood pressure (SBP in several populations, but the size of the effect varies among studies. We performed a meta-analysis including all published studies to evaluate the SBP-lowering effect of IPP/VPP in Japanese subjects more comprehensively.Eligible randomized controlled trials were searched for within four bibliographic databases, including two Japanese ones. Eighteen studies (including a total of 1194 subjects were included in the meta-analysis. A random effect model using the restricted maximum likelihood (REML estimator was used for the analysis. The analysis showed that consumption of IPP/VPP induced a significant reduction in SBP as compared with placebo in Japanese subjects, with an estimated effect of -5.63 mm Hg (95% CI, -6.87 to -4.39, P<0.0001 and no evidence of publication bias. A significant heterogeneity between series was evident, which could be explained by a significant influence of the baseline blood pressure status of the subjects, the effect of IPP/VPP on SBP being stronger in hypertensive subjects (-8.35 mm Hg, P<0.0001 than in non-hypertensive subjects (-3.42mm Hg, P<0.0001. Furthermore, the effect of IPP/VPP on SBP remained significant when limiting the analysis to series that tested the usual doses of IPP/VPP consumed daily (below 5 mg/d, with estimated effects of -6.01 mm Hg in the overall population and -3.32 mm Hg in non-hypertensive subjects.Results from this meta-analysis show that IPP/VPP lactotripeptides can significantly reduce office SBP in Japanese subjects with or without overt hypertension, and for doses that can potentially be consumed as an everyday supplement. This suggests that these peptides could play a role in controlling blood pressure in Japanese subjects. The systematic review protocol was published on the PROSPERO register (CRD42014014322.

Simultaneous radar and spaced receiver VHF scintillation observations of ESF irregularities

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D. Tiwari

2006-07-01

Full Text Available Simultaneous observations of equatorial spread F (ESF irregularities made on 10 nights during March-April 1998 and 1999, using an 18-MHz radar at Trivandrum (77° E, 8.5° N, dip 0.5° N and two spaced receivers recording scintillations on a 251-MHz signal at Tirunelveli (77.8° E, 8.7° N, dip 0.4° N, have been used to study the evolution of Equatorial Spread F (ESF irregularities. Case studies have been carried out on the day-to-day variability in ESF structure and dynamics, as observed by 18-MHz radar, and with spaced receiver measurements of average zonal drift Vo of the 251-MHz radio wave diffraction pattern on the ground, random velocity Vc, which is a measure of random changes in the characteristics of scintillation-producing irregularities, and maximum cross-correlation CI of the spaced receivers signals. Results show that in the initial phase of plasma bubble development, the greater the maximum height of ESF irregularities responsible for the radar backscatter, the greater the decorrelation is of the spaced receiver scintillation signals, indicating greater turbulence. The relationship of the maximum spectral width derived from the radar observations and CI also supports this result.

Effect of Play-based Therapy on Meta-cognitive and Behavioral Aspects of Executive Function: A Randomized, Controlled, Clinical Trial on the Students With Learning Disabilities.

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Karamali Esmaili, Samaneh; Shafaroodi, Narges; Hassani Mehraban, Afsoon; Parand, Akram; Zarei, Masoume; Akbari-Zardkhaneh, Saeed

2017-01-01

Although the effect of educational methods on executive function (EF) is well known, training this function by a playful method is debatable. The current study aimed at investigating if a play-based intervention is effective on metacognitive and behavioral skills of EF in students with specific learning disabilities. In the current randomized, clinical trial, 49 subjects within the age range of 7 to 11 years with specific learning disabilities were randomly assigned into the intervention (25 subjects; mean age 8.5±1.33 years) and control (24 subjects; mean age 8.7±1.03 years) groups. Subjects in the intervention group received EF group training based on playing activities; subjects in the control group received no intervention. The behavior rating inventory of executive function (BRIEF) was administered to evaluate the behavioral and cognitive aspects of EF. The duration of the intervention was 6 hours per week for 9 weeks. Multivariate analysis of covariance was used to compare mean changes (before and after) in the BRIEF scores between the groups. The assumptions of multivariate analysis of covariance were examined. After controlling pre-test conditions, the intervention and control groups scored significantly differently on both the metacognition (P=0.002; effect size=0.20) and behavior regulation indices (P=0.01; effect size=0.12) of BRIEF. Play-based therapy is effective on the metacognitive and behavioral aspects of EF in students with specific learning disabilities. Professionals can use play-based therapy rather than educational approaches in clinical practice to enhance EF skills.

A prospective randomized study of the effectiveness of aromatherapy for relief of postoperative nausea and vomiting.

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Hodge, Nancy S; McCarthy, Mary S; Pierce, Roslyn M

2014-02-01

Postoperative nausea and vomiting (PONV) is a major concern for patients having surgery under general anesthesia as it causes subjective distress along with increased complications and delays in discharge from the hospital. Aromatherapy represents a complementary and alternative therapy for the management of PONV. The objective of this study was to compare the effectiveness of aromatherapy (QueaseEase, Soothing Scents, Inc, Enterprise, AL) versus an unscented inhalant in relieving PONV. One hundred twenty-one patients with postoperative nausea were randomized into a treatment group receiving an aromatic inhaler and a control group receiving a placebo inhaler to evaluate the effectiveness of aromatherapy. Initial and follow-up nausea assessment scores in both treatment and placebo groups decreased significantly (P aromatherapy was significantly higher in the treatment group (P Aromatherapy was favorably received by most patients and represents an effective treatment option for postoperative nausea. Published by Elsevier Inc.

Language-specific strategy for programming hearing aids - A double-blind randomized controlled crossover study.

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Matsumoto, Nozomu; Suzuki, Nobuyoshi; Iwasaki, Satoshi; Ishikawa, Kazuha; Tsukiji, Hiroki; Higashino, Yoshie; Tabuki, Tomoko; Nakagawa, Takashi

2018-08-01

Voice-aligned compression (VAC) is a method used in Oticon's hearing aids to provide more comfortable hearing without sacrificing speech discrimination. The complex, non-linear compression curve for the VAC strategy is designed based on the frequency profile of certain spoken Western languages. We hypothesized that hearing aids could be further customized for Japanese-speaking users by modifying the compression curve using the frequency profile of spoken Japanese. A double-blind randomized controlled crossover study was performed to determine whether or not Oticon's modified amplification strategy (VAC-J) provides subjectively preferable hearing aids for Japanese-speaking hearing aid users compared to the same company's original amplification strategy (VAC). The participants were randomized to two groups. The VAC-first group received a pair of hearing aids programmed using the VAC strategy and wore them for three weeks, and then received a pair of hearing aids programmed using VAC-J strategy and wore them for three weeks. The VAC-J-first group underwent the same study, but they received hearing aids in the reverse sequence. A Speech, Spatial and Qualities (SSQ) questionnaire was administered before beginning to use the hearing aids, at the end of using the first pair of hearing aids, and at the end of using the second pair of hearing aids. Twenty-five participants that met the inclusion/exclusion criteria from January 1 to October 31, 2016, were randomized to two groups. Twenty-two participants completed the study. There were no statistically significant differences in the increment of SSQ scores between the participants when using the VAC- or the VAC-J-programmed hearing aids. However, participants preferred the VAC-J strategy to the VAC strategy at the end of the study, and this difference was statistically significant. Japanese-speaking hearing aid users preferred using hearing aids that were fitted with the VAC-J strategy. Our results show that the VAC strategy

Comparing Effects of Melatonin versus Trazodone on Sleep Quality in Major Depressed Patients Receiving Sertraline

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Zahra Mirsepassi

2018-02-01

Full Text Available Background_ Sleep disturbance is a common complaint in major depressive disorder (MDD including impairment of both subjective and objective parameters, Also SSRIs as antidepressant drugs can affect sleep architecture (SA.Aim _This randomized trial was designed to compare the effects of trazodone with melatonin on sleep quality (SQ of patients with MDD based on Diagnostic and Statistical Manual for Mental Disorders –5th edition (DSM-5 criteria.Method_ Sixty patients who have the study criteria were entered in this study and were divided into two groups receiving either trazodone or melatonin. They were evaluated for sleep quality and depression severity by using Pittsburgh Sleep Quality Index (PSQI and Hamilton Depression Rating Scale (HAM-D at baseline and after 4 and 8 weeks.Result_ Thirty two patients complete the study. Fourteen patients received 3mg of melatonin and eighteen patients received 50mg of trazodone before sleep time. After 4 and 8 weeks treatment with melatonin or Trazodone, significant improvements in SQ were showed in both groups. Additionally, a significant reduction in sleep latency (SL was showed after 4 weeks of treatment with melatonin but not with trazodone.Conclusion_ This study demonstrated that both Melatonin and Trazodone improved SQ in outpatients with MDD after 8 weeks of treatment but melatonin created greater reduction in SL than trazodone after 4 weeks.

The interblink interval in normal and dry eye subjects

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Johnston PR

2013-02-01

Full Text Available Patrick R Johnston,1 John Rodriguez,1 Keith J Lane,1 George Ousler,1 Mark B Abelson1,21Ora, Inc, Andover, MA, USA; 2Schepens Eye Research Institute and Harvard Medical School, Boston, MA, USAPurpose: Our aim was to extend the concept of blink patterns from average interblink interval (IBI to other aspects of the distribution of IBI. We hypothesized that this more comprehensive approach would better discriminate between normal and dry eye subjects.Methods: Blinks were captured over 10 minutes for ten normal and ten dry eye subjects while viewing a standardized televised documentary. Fifty-five blinks were analyzed for each of the 20 subjects. Means, standard deviations, and autocorrelation coefficients were calculated utilizing a single random effects model fit to all data points and a diagnostic model was subsequently fit to predict probability of a subject having dry eye based on these parameters.Results: Mean IBI was 5.97 seconds for normal versus 2.56 seconds for dry eye subjects (ratio: 2.33, P = 0.004. IBI variability was 1.56 times higher in normal subjects (P < 0.001, and the autocorrelation was 1.79 times higher in normal subjects (P = 0.044. With regard to the diagnostic power of these measures, mean IBI was the best dry eye versus normal classifier using receiver operating characteristics (0.85 area under curve (AUC, followed by the standard deviation (0.75 AUC, and lastly, the autocorrelation (0.63 AUC. All three predictors combined had an AUC of 0.89. Based on this analysis, cutoffs of ≤3.05 seconds for median IBI, and ≤0.73 for the coefficient of variation were chosen to classify dry eye subjects.Conclusion: (1 IBI was significantly shorter for dry eye patients performing a visual task compared to normals; (2 there was a greater variability of interblink intervals in normal subjects; and (3 these parameters were useful as diagnostic predictors of dry eye disease. The results of this pilot study merit investigation of IBI

Reiki for the treatment of fibromyalgia: a randomized controlled trial.

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Assefi, Nassim; Bogart, Andy; Goldberg, Jack; Buchwald, Dedra

2008-11-01

Fibromyalgia is a common, chronic pain condition for which patients frequently use complementary and alternative medicine, including Reiki. Our objective was to determine whether Reiki is beneficial as an adjunctive fibromyalgia treatment. This was a factorial designed, randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group. The study setting was private medical offices in the Seattle, Washington metropolitan area. The subjects were comprised 100 adults with fibromyalgia. Four (4) groups received twice-weekly treatment for 8 weeks by either a Reiki master or actor randomized to use direct touch or no touch (distant therapy). The primary outcome was subjective pain as measured by visual analog scale at weeks 4, 8, and 20 (3 months following end of treatment). Secondary outcomes were physical and mental functioning, medication use, and health provider visits. Participant blinding and adverse effects were ascertained by self-report. Improvement between groups was examined in an intention-to-treat analysis. Neither Reiki nor touch had any effect on pain or any of the secondary outcomes. All outcome measures were nearly identical among the 4 treatment groups during the course of the trial. Neither Reiki nor touch improved the symptoms of fibromyalgia. Energy medicine modalities such as Reiki should be rigorously studied before being recommended to patients with chronic pain symptoms.

Effectiveness of a nursing intervention during transfusion of packed red cells on the patient´s anxiety state receiver

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Jesús Fernando Martín Díaz

2012-05-01

Full Text Available The transfusion provokes anxiety and this one compromises the improvement of the patient. Objetive: The study aims to evaluate whether a nursing intervention protocol-through oral and written submissions previous to the transfusion of packed red blood cells decreases anxiety levels in pretransfusion and postransfusion recipient patients through a randomized clinical trial. Methodology: Be conducted in patients over 18 years admitted in the Hospitable complex of Toledo, prescription transfusion of packed red blood cells. For an alpha error 0.05, beta error of 0.90, with an expected effect of 10%, need 70 subjects in each group. The allocation to the intervention group and the control group was randomly made simple. The performance in the normal control group will be done in the hospital, patients receiving transfusion. As dependent variables evaluated:- The anxiety level pretransfusion and postransfusion. Using the questionnaire was validated by Spielberger (STAI. - The level of satisfaction perceived by the user on the information received prior to transfusion. By design developed for this study. Also recorded other control variables: sex, age, socio-cultural level, marital status, reason for transfusion, or no knowledge of the prescription of transfusion, incidents during transfusion.Scientific and sociosanitary relevancy of the study: The results will allow to know if the transfusion increases the anxiety and if an educational intervention nurse can diminish it; and to do the intervention before every transfusion.

Random Decrement

DEFF Research Database (Denmark)

Asmussen, J. C.; Ibrahim, S. R.; Brincker, Rune

This paper demonstrates how to use the Random Decrement (RD) technique for identification of linear structures subjected to ambient excitation. The theory behind the technique will be presented and guidelines how to choose the different variables will be given. This is done by introducing a new...

Random Decrement

DEFF Research Database (Denmark)

Asmussen, J. C.; Ibrahim, R.; Brincker, Rune

1998-01-01

This paper demonstrates how to use the Random Decrement (RD) technique for identification of linear structures subjected to ambient excitation. The theory behind the technique will be presented and guidelines how to choose the different variables will be given. This is done by introducing a new...

Electronic warfare receivers and receiving systems

CERN Document Server

Poisel, Richard A

2014-01-01

Receivers systems are considered the core of electronic warfare (EW) intercept systems. Without them, the fundamental purpose of such systems is null and void. This book considers the major elements that make up receiver systems and the receivers that go in them.This resource provides system design engineers with techniques for design and development of EW receivers for modern modulations (spread spectrum) in addition to receivers for older, common modulation formats. Each major module in these receivers is considered in detail. Design information is included as well as performance tradeoffs o

People's Intuitions about Randomness and Probability: An Empirical Study

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Lecoutre, Marie-Paule; Rovira, Katia; Lecoutre, Bruno; Poitevineau, Jacques

2006-01-01

What people mean by randomness should be taken into account when teaching statistical inference. This experiment explored subjective beliefs about randomness and probability through two successive tasks. Subjects were asked to categorize 16 familiar items: 8 real items from everyday life experiences, and 8 stochastic items involving a repeatable…

Randomized, double-blinded clinical trial for human norovirus inactivation in oysters by high hydrostatic pressure processing.

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Leon, Juan S; Kingsley, David H; Montes, Julia S; Richards, Gary P; Lyon, G Marshall; Abdulhafid, Gwen M; Seitz, Scot R; Fernandez, Marina L; Teunis, Peter F; Flick, George J; Moe, Christine L

2011-08-01

Contamination of oysters with human noroviruses (HuNoV) constitutes a human health risk and may lead to severe economic losses in the shellfish industry. There is a need to identify a technology that can inactivate HuNoV in oysters. In this study, we conducted a randomized, double-blinded clinical trial to assess the effect of high hydrostatic pressure processing (HPP) on Norwalk virus (HuNoV genogroup I.1) inactivation in virus-seeded oysters ingested by subjects. Forty-four healthy, positive-secretor adults were divided into three study phases. Subjects in each phase were randomized into control and intervention groups. Subjects received Norwalk virus (8FIIb, 1.0 × 10(4) genomic equivalent copies) in artificially seeded oysters with or without HPP treatment (400 MPa at 25°C, 600 MPa at 6°C, or 400 MPa at 6°C for 5 min). HPP at 600 MPa, but not 400 MPa (at 6° or 25°C), completely inactivated HuNoV in seeded oysters and resulted in no HuNoV infection among these subjects, as determined by reverse transcription-PCR detection of HuNoV RNA in subjects' stool or vomitus samples. Interestingly, a white blood cell (granulocyte) shift was identified in 92% of the infected subjects and was significantly associated with infection (P = 0.0014). In summary, these data suggest that HPP is effective at inactivating HuNoV in contaminated whole oysters and suggest a potential intervention to inactivate infectious HuNoV in oysters for the commercial shellfish industry.

Therapeutic effects of mosapride citrate and lansoprazole for prevention of aspiration pneumonia in patients receiving gastrostomy feeding.

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Takatori, Kento; Yoshida, Rihito; Horai, Aya; Satake, Shinya; Ose, Takayuki; Kitajima, Naoto; Yoneda, Shushi; Adachi, Kyoichi; Amano, Yuji; Kinoshita, Yoshikazu

2013-10-01

Aspiration pneumonia is an emerging problem in patients receiving gastrostomy feeding. This study is designed to clarify the therapeutic effects of mosapride citrate and lansoprazole for prevention of aspiration pneumonia in patients receiving gastrostomy feeding. The study subjects were 119 patients with dysphasia who required gastrostomy feeding. They were randomly assigned to the control (without medication), lansoprazole (15 mg, 1/day), and mosapride (5 mg, 3/day) groups. The number of days with fever (≥37.8 °C), vomiting, and antibiotics administration, as well as the occurrence of pneumonia were investigated during the 6-month observation period. The incidence of pneumonia during the observation period was significantly lower in the mosapride group as compared to the control (7/38 vs. 16/40, p = 0.038) and lansoprazole (vs. 20/41, p = 0.005) groups. The mosapride group also showed a significant decrease in days with fever and antibiotics administration as compared to the other groups. Multivariate analysis revealed that the presence of hiatal hernia was a significant risk factor and administration of mosapride was a significant preventive factor for pneumonia. Mosapride has a preventive effect on occurrence of pneumonia in patients receiving gastrostomy feeding.

Dissecting the circle, at random*

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Curien Nicolas

2014-01-01

Full Text Available Random laminations of the disk are the continuous limits of random non-crossing configurations of regular polygons. We provide an expository account on this subject. Initiated by the work of Aldous on the Brownian triangulation, this field now possesses many characters such as the random recursive triangulation, the stable laminations and the Markovian hyperbolic triangulation of the disk. We will review the properties and constructions of these objects as well as the close relationships they enjoy with the theory of continuous random trees. Some open questions are scattered along the text.

The effects of mindfulness-based stress reduction on objective and subjective sleep parameters in women with breast cancer: a randomized controlled trial.

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Lengacher, Cecile A; Reich, Richard R; Paterson, Carly L; Jim, Heather S; Ramesar, Sophia; Alinat, Carissa B; Budhrani, Pinky H; Farias, Jerrica R; Shelton, Melissa M; Moscoso, Manolete S; Park, Jong Y; Kip, Kevin E

2015-04-01

The purpose of this study was to investigate the effects of mindfulness-based stress reduction for breast cancer survivors (MBSR(BC)) on multiple measures of objective and subjective sleep parameters among breast cancer survivors (BCS). Data were collected using a two-armed randomized controlled design among BCS enrolled in either a 6-week MBSR(BC) program or a usual care (UC) group with a 12-week follow-up. The present analysis is a subset of the larger parent trial (ClinicalTrials.gov Identifier: NCT01177124). Seventy-nine BCS participants (mean age 57 years), stages 0-III, were randomly assigned to either the formal (in-class) 6-week MBSR(BC) program or UC. Subjective sleep parameters (SSP) (i.e., sleep diaries and the Pittsburgh Sleep Quality Index (PSQI)) and objective sleep parameters (OSP) (i.e., actigraphy) were measured at baseline, 6 weeks, and 12 weeks after completing the MBSR(BC) or UC program. Results showed indications of a positive effect of MBSR(BC) on OSP at 12 weeks on sleep efficiency (78.2% MBSR(BC) group versus 74.6% UC group, p = 0.04), percent of sleep time (81.0% MBSR(BC) group versus 77.4% UC group, p = 0.02), and less number waking bouts (93.5 in MBSR(BC) group versus 118.6 in the UC group, p sleep parameters in BCS. Copyright © 2014 John Wiley & Sons, Ltd.

Received social support and exercising: An intervention study to test the enabling hypothesis.

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Rackow, Pamela; Scholz, Urte; Hornung, Rainer

2015-11-01

Received social support is considered important for health-enhancing exercise participation. The enabling hypothesis of social support suggests an indirect association of social support and exercising via constructs of self-regulation, such as self-efficacy. This study aimed at examining an expanded enabling hypothesis by examining effects of different kinds of social support (i.e., emotional and instrumental) on exercising not only via self-efficacy but also via self-monitoring and action planning. An 8-week online study was conducted. Participants were randomly assigned to an intervention or a control group. The intervention comprised finding and then exercising regularly with a new exercise companion. Intervention and control group effects were compared by a manifest multigroup model. Received emotional social support predicted self-efficacy, self-monitoring, and action planning in the intervention group. Moreover, received emotional social support was indirectly connected with exercise via the examined mediators. The indirect effect from received emotional social support via self-efficacy mainly contributed to the total effect. No direct or indirect effect of received instrumental social support on exercise emerged. In the control group, neither emotional nor instrumental social support was associated with any of the self-regulation constructs nor with exercise. Actively looking for a new exercise companion and exercising together seems to be beneficial for the promotion of received emotional and instrumental social support. Emotional support in turn promotes exercise by enabling better self-regulation, in particular self-efficacy. Statement of contribution What is already known on this subject? With the 'enabling hypothesis', Benight and Bandura (2004, Behav. Res. Ther., 42, 1129) claimed that social support indirectly affects behaviour via self-efficacy. Research in the domain of physical exercise has provided evidence for this enabling hypothesis on a

Acute Consumption of Resistant Starch Reduces Food Intake but Has No Effect on Appetite Ratings in Healthy Subjects.

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Ble-Castillo, Jorge L; Juárez-Rojop, Isela E; Tovilla-Zárate, Carlos A; García-Vázquez, Carlos; Servin-Cruz, Magda Z; Rodríguez-Hernández, Arturo; Araiza-Saldaña, Claudia I; Nolasco-Coleman, Ana M; Díaz-Zagoya, Juan C

2017-07-04

Previous studies have shown the benefits of native banana starch (NBS) supplementation in improving glucose metabolism and reducing body weight (BW) in humans. However, the effect of this starch on appetite regulation is unknown. The aim of this study was to examine the effects of NBS rich resistant starch on subjective measurements of appetite, energy intake, and appetite hormones in healthy subjects. Postprandial glucose and insulin responses were also assessed. In a randomized, single-blind, crossover study, 28 healthy young subjects consumed a beverage containing either 40 g of NBS or 40 g of digestible corn starch (DCS) on two separate occasions. Effects on appetite were estimated using visual analogue scales (VAS) and satiety hormone responses. At the end of the intervention, participants were provided with a pre-weighed ad libitum homogeneous test meal. After a washout period of 1 week, subjects received the alternative treatment. NBS supplementation induced a reduction in food intake, glucose area under the curve (AUC)-180 min, and insulin AUC-180 min. However, there was no associated effect on the subjective appetite ratings or gut hormones. NBS supplementation may help to reduce meal size and control BW.

Social support and subjective burden in caregivers of adults and older adults: A meta-analysis.

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Del-Pino-Casado, Rafael; Frías-Osuna, Antonio; Palomino-Moral, Pedro A; Ruzafa-Martínez, María; Ramos-Morcillo, Antonio J

2018-01-01

Despite the generally accepted belief that social support improves caregiver adjustment in general and subjective burden in particular, the literature shows mixed findings, and a recent review concluded that the predictive strength of caregiver social support in determining caregiver burden is less evident, due to the conceptual diversity of this determinant. The purpose of this review is to analyse the relationship of perceived and received social support with subjective burden among informal caregivers of an adult or older adult. A systematic search was carried out up to September 2017 in the following databases: MEDLINE (PubMed), CINAHL, EMBASE, PsycINFO), Scopus and ISI Proceedings, and a meta-analysis was performed with the results of the selected and included studies. Fifty-six studies were included in the meta-analysis, which provided 46 independent comparisons for perceived support and 16 for received support. Most of these studies were cross-sectional. There was a moderate, negative association of perceived social support on subjective burden (r = -0.36; CI 95% = -0.40, -0.32) and a very small, negative association of received support on subjective burden (r = -0.05; CI 95% = -0.095, -0.001). 1) perceived and received support are not redundant constructs, 2) the relationships between social support and subjective burden depend on whether the social support is measured as perceived or received, 3) the relationship of perceived social support with subjective burden has a bigger effect size than that of received social support, the relation between received support and subjective burden being clinically irrelevant, 4) perceived social support may be a good predictor of subjective burden. Our findings broadly support interventions promoting social support in caregivers to prevent or alleviate subjective burden, and specifically, to intervene on the promotion of perceived social support more than on the promotion of received social support when preventing or

Beneficial effects of dark chocolate on exercise capacity in sedentary subjects: underlying mechanisms. A double blind, randomized, placebo controlled trial.

Science.gov (United States)

Taub, Pam R; Ramirez-Sanchez, Israel; Patel, Minal; Higginbotham, Erin; Moreno-Ulloa, Aldo; Román-Pintos, Luis Miguel; Phillips, Paul; Perkins, Guy; Ceballos, Guillermo; Villarreal, Francisco

2016-09-14

In heart failure patients the consumption of (-)-epicatechin ((-)-Epi)-rich cocoa can restore skeletal muscle (SkM) mitochondrial structure and decrease biomarkers of oxidative stress. However, nothing is known about its effects on exercise capacity and underlying mechanisms in normal, sedentary subjects. Twenty normal, sedentary subjects (∼50 years old) were randomized to placebo or dark chocolate (DC) groups and consumed 20 g of the products for 3 months. Subjects underwent before and after treatment, bicycle ergometry to assess VO2 max and work, SkM biopsy to assess changes in mitochondrial density, function and oxidative stress and blood sampling to assess metabolic endpoints. Seventeen subjects completed the trial. In the DC group (n = 9), VO2 max increased (17% increase, p = 0.056) as well as maximum work (watts) achieved (p = 0.026) with no changes with placebo (n = 8). The DC group evidenced increases in HDL levels (p = 0.005) and decreased triglycerides (p = 0.07). With DC, SkM evidenced significant increases in protein levels for LKB1, AMPK and PGC1α and in their active forms (phosphorylated AMPK and LKB1) as well as in citrate synthase activity while no changes were observed in mitochondrial density. With DC, significant increases in SkM reduced glutathione levels and decreases in protein carbonylation were observed. Improvements in maximum work achieved and VO2 max may be due to DC activation of upstream control systems and enhancement of SkM mitochondria efficiency. Larger clinical studies are warranted to confirm these observations.

A randomized, controlled comparison of home versus institutional rehabilitation of patients with hip fracture.

Science.gov (United States)

Kuisma, Raija

2002-08-01

To compare ambulation outcomes between home and institutional rehabilitation of patients with hip fracture. Randomized controlled clinical equivalence trial. The Queen Elizabeth Hospital in Hong Kong. Eighty-one patients with hip fracture. Study group patients (40) were discharged directly home from the acute hospital and visited by a physiotherapist an average of 4.6 times. The control group subjects (41) were discharged to a rehabilitation centre for further treatment lasting on average 36.2 days (SD 14.6) and they received physiotherapy daily. Ambulation ability measured on a categorical scale. The mean age of the subjects was 75 years (SD 8.3 years). Females comprised 60% of all the subjects and majority were retired or home makers. Both groups of patients improved in their ambulation ability during their rehabilitation period but neither group achieved their pre-ambulatory status by the time of completion of the study. The study group achieved significantly higher ambulation scores (p institution-based rehabilitation.

Infant and Young Child Feeding Practices in Infants Receiving Skin to Skin Care at Birth: Follow-up of Randomized Cohort.

Science.gov (United States)

Nimbalkar, Archana Somashekhar; Patel, Dipen Vasudev; Nimbalkar, Somashekhar Marutirao; Patel, Vijay Karshanbhai; Patel, Dhaval Nileshbhai; Phatak, Ajay Gajanan

2016-12-01

Skin to Skin Care (SSC) in neonatal period influences immediate breastfeeding outcomes in early childhood, especially the duration of exclusive breastfeeding. We investigated influence of 17 hours of SSC given from day one of life on Infant and Young Child Feeding (IYCF) practices through one year of life. Follow-up of a Superiority Randomized Control Trial (RCT) (CTRI/2013/06/003790) conducted in a teaching hospital located in central Gujarat. Mothers of 100 neonates (48 girls, 52 boys) from previous study cohort of RCT on SSC were followed. A survey on IYCF practices during the first year of life was administered after the end of infancy. In RCT, 50 neonates had received SSC beginning of 30 min- 1 hour after birth for average 17 hours on day 1 of life. In the control group, 50 newborn were placed next to the mother and conventional care was provided. There was a significant difference between hypothermia incidences in these groups in the first two days of life. There was no difference in the groups as far as the duration of exclusive breastfeeding, number of times breastfed per day, or stoppage of night feeds. No baby in either group received bottled feeds but about 53 received some form of extra lacteal feeds in the first 6 months without significant group difference. Fewer SSC mothers reported difficulties with breastfeeding or extra lacteal supplementation. All mothers who faced problems contacted physicians for advice and 20 were advised top milk and 6 given other foods. At one year of life 66% mothers were giving less than the recommended five food servings. There was no difference in practices related to hand washing, food preparation and storage, feeding habits of child and illness episodes in the children. IYCF practices in this small group were not as per guidelines. Few positive trends were seen with fewer SSC mothers facing problems related to breastfeeding. The study was underpowered to detect differences in IYCF practices in relation to SSC.

Single- and Multiple-Dose Study To Determine the Safety, Tolerability, Pharmacokinetics, and Food Effect of Oral MRX-I versus Linezolid in Healthy Adult Subjects.

Science.gov (United States)

Eckburg, Paul B; Ge, Yigong; Hafkin, Barry

2017-04-01

A multipart phase 1 study was conducted to determine the safety, tolerability, pharmacokinetics, and food effect of the novel oral oxazolidinone, MRX-I, in healthy adults, as well as the tolerability of longer-term exposure of both oral MRX-I and linezolid. Thirty subjects in part 1 received single ascending doses of MRX-I or placebo under fasting or fed condition in a double-blind crossover design. Twelve subjects in part 2 received MRX-I at 800 mg every 12 h (q12h) for 14 days in a double-blind, placebo-controlled design. In part 3, 24 subjects were randomized to receive 28 days of MRX-I at 800 mg q12h or oral linezolid at 600 mg q12h for 28 days in a double-blind, double-dummy design. Oral MRX-I was associated with a greater bioavailability and exposure when administered with food, and minimal accumulation of MRX-I occurred after multiple-dose administration. Oral MRX-I was well tolerated at single doses of up to 1,200 and 800 mg q12h for up to 28 days; all adverse events were mild to moderate in severity, and there was no drug discontinuation due to adverse events. These data support further clinical development of oral MRX-I in the treatment of resistant Gram-positive bacterial infections. Copyright © 2017 American Society for Microbiology.

An Efficient Rank Adaptation Algorithm for Cellular MIMO Systems with IRC Receivers

DEFF Research Database (Denmark)

Mahmood, Nurul Huda; Berardinelli, Gilberto; Tavares, Fernando Menezes Leitão

2014-01-01

Multiple transmit and receive antennas introduce additional degrees of freedom, which can be used to increase the number of spatial channels between a transmitter-receiver pair. Alternately, the additional degrees of freedom can be used to improve the interference resilience property with the help...... algorithm based on an estimate of the mean signal-to-interference-plus-noise ratio (SINR) at an IRC receiver; wherein, we use results from random matrix theory to derive the expression for the mean post-IRC SINR in the presence of interferers with unequal powers. The performance of the proposed algorithm...

Multicenter, randomized, controlled trial of virtual-reality simulator training in acquisition of competency in colonoscopy.

Science.gov (United States)

Cohen, Jonathan; Cohen, Seth A; Vora, Kinjal C; Xue, Xiaonan; Burdick, J Steven; Bank, Simmy; Bini, Edmund J; Bodenheimer, Henry; Cerulli, Maurice; Gerdes, Hans; Greenwald, David; Gress, Frank; Grosman, Irwin; Hawes, Robert; Mullin, Gerard; Mullen, Gerard; Schnoll-Sussman, Felice; Starpoli, Anthony; Stevens, Peter; Tenner, Scott; Villanueva, Gerald

2006-09-01

The GI Mentor is a virtual reality simulator that uses force feedback technology to create a realistic training experience. To define the benefit of training on the GI Mentor on competency acquisition in colonoscopy. Randomized, controlled, blinded, multicenter trial. Academic medical centers with accredited gastroenterology training programs. First-year GI fellows. Subjects were randomized to receive 10 hours of unsupervised training on the GI Mentor or no simulator experience during the first 8 weeks of fellowship. After this period, both groups began performing real colonoscopies. The first 200 colonoscopies performed by each fellow were graded by proctors to measure technical and cognitive success, and patient comfort level during the procedure. A mixed-effects model comparison between the 2 groups of objective and subjective competency scores and patient discomfort in the performance of real colonoscopies over time. Forty-five fellows were randomized from 16 hospitals over 2 years. Fellows in the simulator group had significantly higher objective competency rates during the first 100 cases. A mixed-effects model demonstrated a higher objective competence overall in the simulator group (P < .0001), with the difference between groups being significantly greater during the first 80 cases performed. The median number of cases needed to reach 90% competency was 160 in both groups. The patient comfort level was similar. Fellows who underwent GI Mentor training performed significantly better during the early phase of real colonoscopy training.

Randomized trial of a combination of natural products (cernitin, saw palmetto, B-sitosterol, vitamin E) on symptoms of benign prostatic hyperplasia (BPH).

Science.gov (United States)

Preuss, H G; Marcusen, C; Regan, J; Klimberg, I W; Welebir, T A; Jones, W A

2001-01-01

Because benign prostatic hyperplasia (BPH) is relatively common, it is important to discover safe and effective means to treat this often debilitating perturbation. Accordingly, we examined the effectiveness of a combination of natural products (cernitin, saw palmetto, B-sitosterol, vitamin E) in treating symptoms of BPH. We undertook a randomized, placebo-controlled, double-blind study. Patients were enrolled from 3 urological practices in the USA. 144 subjects were randomized for study. 17 subjects eventually withdrew, leaving 70 patients in the test group and 57 in the placebo group to complete the study. Inclusion criteria consisted of a diagnosis of BPH, no evidence of cancer, and a maximal urinary flow rate between 5 and 15 ml/second. Patients received either placebo or the combined natural products for 3 months. Evaluations were performed via the American Urological Association (AUA) Symptom Index score, urinary flow rate, PSA measurement, and residual bladder volume. Nocturia showed a markedly significant decrease in severity in patients receiving the combined natural products compared to those taking placebo (p saw palmetto, B-sitosterol, vitamin E) compared to placebo can significantly lessen nocturia and frequency and diminish overall symptomatology of BPH as indicated by an improvement in the total AUA Symptom Index score. The combination of natural products caused no significant adverse side effects.

The Effectiveness of Cupping Therapy on Relieving Chronic Neck and Shoulder Pain: A Randomized Controlled Trial.

Science.gov (United States)

Chi, Lee-Mei; Lin, Li-Mei; Chen, Chien-Lin; Wang, Shu-Fang; Lai, Hui-Ling; Peng, Tai-Chu

2016-01-01

The research aimed to investigate the effectiveness of cupping therapy (CT) in changes on skin surface temperature (SST) for relieving chronic neck and shoulder pain (NSP) among community residents. A single-blind experimental design constituted of sixty subjects with self-perceived NSP. The subjects were randomly allocated to two groups. The cupping group received CT at SI 15, GB 21, and LI 15 acupuncture points, and the control group received no intervention. Pain was assessed using the SST, visual analog scale (VAS), and blood pressure (BP). The main results were SST of GB 21 acupuncture point raised from 30.6°C to 32.7°C and from 30.7°C to 30.6°C in the control group. Neck pain intensity (NPI) severity scores were reduced from 9.7 to 3.6 in the cupping group and from 9.7 to 9.5 in the control group. The SST and NPI differences between the groups were statistically significant (P < 0.001). One treatment of CT is shown to increase SST. In conjunction with the physiological effect the subjective experience of NSP is reduced in intensity. Further studies are required to improve the understanding and potential long-term effects of CT.

The Effectiveness of Cupping Therapy on Relieving Chronic Neck and Shoulder Pain: A Randomized Controlled Trial

Directory of Open Access Journals (Sweden)

Lee-Mei Chi

2016-01-01

Full Text Available The research aimed to investigate the effectiveness of cupping therapy (CT in changes on skin surface temperature (SST for relieving chronic neck and shoulder pain (NSP among community residents. A single-blind experimental design constituted of sixty subjects with self-perceived NSP. The subjects were randomly allocated to two groups. The cupping group received CT at SI 15, GB 21, and LI 15 acupuncture points, and the control group received no intervention. Pain was assessed using the SST, visual analog scale (VAS, and blood pressure (BP. The main results were SST of GB 21 acupuncture point raised from 30.6°C to 32.7°C and from 30.7°C to 30.6°C in the control group. Neck pain intensity (NPI severity scores were reduced from 9.7 to 3.6 in the cupping group and from 9.7 to 9.5 in the control group. The SST and NPI differences between the groups were statistically significant (P < 0.001. One treatment of CT is shown to increase SST. In conjunction with the physiological effect the subjective experience of NSP is reduced in intensity. Further studies are required to improve the understanding and potential long-term effects of CT.

Kefir drink leads to a similar weight loss, compared with milk, in a dairy-rich non-energy-restricted diet in overweight or obese premenopausal women: a randomized controlled trial.

Science.gov (United States)

Fathi, Yasamin; Faghih, Shiva; Zibaeenezhad, Mohammad Javad; Tabatabaei, Sayed Hamid Reza

2016-02-01

Controversy exists regarding whether increasing dairy intake without energy restriction would lead to weight loss. We aimed to compare the potential weight-reducing effects of kefir drink (a probiotic dairy product) and milk in a dairy-rich non-energy-restricted diet in overweight or obese premenopausal women. One hundred and forty-four subjects were assessed for eligibility in this single-center, multi-arm, parallel-group, randomized controlled trial. Of these, seventy-five eligible women aged 25-45 years were randomly assigned to three groups, labeled as control, milk, and kefir, to receive an outpatient dietary regimen for 8 weeks. Subjects in the control group received a diet providing a maintenance level of energy intake, containing 2 servings/day of low-fat dairy products, while those in the milk and kefir groups received a weight maintenance diet, containing 2 additional servings/day (a total of 4 servings/day) of dairy products from low-fat milk or commercial kefir drink, respectively. Anthropometric outcomes including weight, body mass index (BMI), and waist circumference (WC) were measured every 2 weeks. Fifty-eight subjects completed the study. Using analysis of covariance models in the intention-to-treat population (n = 75), we found that at 8 weeks, subjects in the kefir and milk groups had significantly greater reductions in weight, BMI, and WC compared to those in the control group (all p < 0.01). However, no such significant differences were found between the kefir and milk groups. Kefir drink leads to a similar weight loss, compared with milk, in a dairy-rich non-energy-restricted diet in overweight or obese premenopausal women. However, further studies are warranted.

MR-based conductivity imaging using multiple receiver coils.

Science.gov (United States)

Lee, Joonsung; Shin, Jaewook; Kim, Dong-Hyun

2016-08-01

To propose a signal combination method for MR-based tissue conductivity mapping using a standard clinical scanner with multiple receiver coils. The theory of the proposed method is presented with two practical approaches, a coil-specific approach and a subject-specific approach. Conductivity maps were reconstructed using the transceive phase of the combined signal. The sensitivities of the coefficients used for signal combination were analyzed and the method was compared with other signal combination methods. For validation, multiple receiver brain coils and multiple receiver breast coils were used in phantom, in vivo brain, and in vivo breast studies. The variation among the conductivity estimates was conductivity estimates. MR-based tissue conductivity mapping is feasible when using a standard clinical MR scanner with multiple receiver coils. The proposed method reduces systematic errors in phase-based conductivity mapping that can occur due to the inhomogeneous magnitude of the combined receive profile. Magn Reson Med 76:530-539, 2016. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

System and method for acquisition management of subject position information

Science.gov (United States)

Carrender, Curt

2005-12-13

A system and method for acquisition management of subject position information that utilizes radio frequency identification (RF ID) to store position information in position tags. Tag programmers receive position information from external positioning systems, such as the Global Positioning System (GPS), from manual inputs, such as keypads, or other tag programmers. The tag programmers program each position tag with the received position information. Both the tag programmers and the position tags can be portable or fixed. Implementations include portable tag programmers and fixed position tags for subject position guidance, and portable tag programmers for collection sample labeling. Other implementations include fixed tag programmers and portable position tags for subject route recordation. Position tags can contain other associated information such as destination address of an affixed subject for subject routing.

System and method for acquisition management of subject position information

Energy Technology Data Exchange (ETDEWEB)

Carrender, Curt [Morgan Hill, CA

2007-01-23

A system and method for acquisition management of subject position information that utilizes radio frequency identification (RF ID) to store position information in position tags. Tag programmers receive position information from external positioning systems, such as the Global Positioning System (GPS), from manual inputs, such as keypads, or other tag programmers. The tag programmers program each position tag with the received position information. Both the tag programmers and the position tags can be portable or fixed. Implementations include portable tag programmers and fixed position tags for subject position guidance, and portable tag programmers for collection sample labeling. Other implementations include fixed tag programmers and portable position tags for subject route recordation. Position tags can contain other associated information such as destination address of an affixed subject for subject routing.

Psychotropic medication in a randomly selected group of citizens receiving residential or home care

DEFF Research Database (Denmark)

Futtrup, Tina Bergmann; Schultz, Hanne; Jensen, Margit Bak

2014-01-01

INTRODUCTION: Treatment with one or more psychotropic medications (PMs), especially in the elderly, is associated with risk, and the effects of treatment are poorly validated. The aim of this article was to describe the use of PM in a population of citizens receiving either residential care or home...... care with focus on the prevalence of drug use, the combination of different PMs and doses in relation to current recommendations. METHODS: The medication lists of 214 citizens receiving residential care (122) and home care (92) were collected together with information on age, gender and residential...

Effects of oral vitamin E on treatment of atopic dermatitis: A randomized controlled trial

Directory of Open Access Journals (Sweden)

Fariba Jaffary

2015-01-01

Full Text Available Background: The pathogenesis of atopic dermatitis (AD remains to be determined; recently a possible change in the immune system with production of immunoglobulins is proposed. As vitamin E is a potent antioxidant, with the ability to decrease the serum levels of immunoglobulin E (IgE in atopic patients, we aimed to evaluate the effect of oral vitamin E on treatment of AD. Materials and Methods: This randomized, double-blind, placebo-controlled trial comprised seventy participants with mild-to-moderate AD, based on the Hanifin and Rajka diagnostic criteria. The patients were randomly selected from teaching skin clinics in Isfahan, Iran. They were randomly assigned to two groups of equal number, receiving vitamin E (400 IU/day and placebo for four 4 months. Each month, the extent, severity, and subjective symptoms including itch and sleeplessness were measured by SCORAD index. Three months after the end of intervention, the recurrence rate was assessed. Results: The improvement in all symptoms, except sleeplessness, was significantly higher in the group receiving vitamin E than in controls (-1.5 vs. 0.218 in itching, -10.85 vs. -3.54 in extent of lesion, and -11.12 vs. -3.89 in SCORAD index, respectively, P 0.05. Conclusion: This study suggests that vitamin E can improve the symptoms and the quality of life in patients with AD. As vitamin E has no side effects with a dosage of 400 IU/day, it can be recommended for the treatment of AD.

Effect of cervical vs. thoracic spinal manipulation on peripheral neural features and grip strength in subjects with chronic mechanical neck pain: a randomized controlled trial.

Science.gov (United States)

Bautista-Aguirre, Francisco; Oliva-Pascual-Vaca, Ángel; Heredia-Rizo, Alberto M; Boscá-Gandía, Juan J; Ricard, François; Rodriguez-Blanco, Cleofás

2017-06-01

Cervical and thoracic spinal manipulative therapy has shown positive impact for relief of pain and improve function in non-specific mechanical neck pain. Several attempts have been made to compare their effectiveness although previous studies lacked a control group, assessed acute neck pain or combined thrust and non-thrust techniques. To compare the immediate effects of cervical and thoracic spinal thrust manipulations on mechanosensitivity of upper limb nerve trunks and grip strength in patients with chronic non-specific mechanical neck pain. Randomized, single-blinded, controlled clinical trial. Private physiotherapy clinical consultancy. Eighty-eight subjects (32.09±6.05 years; 72.7% females) suffering neck pain (grades I or II) of at least 12 weeks of duration. Participants were distributed into three groups: 1) cervical group (N.=28); 2) thoracic group (N.=30); and 3) control group (N.=30). One treatment session consisting of applying a high-velocity low-amplitude spinal thrust technique over the lower cervical spine (C7) or the upper thoracic spine (T3) was performed, while the control group received a sham-manual contact. Measurements were taken at baseline and after intervention of the pressure pain threshold over the median, ulnar and radial nerves. Secondary measures included assessing free-pain grip strength with a hydraulic dynamometer. No statistically significant differences were observed when comparing between-groups in any of the outcome measures (P>0.05). Those who received thrust techniques, regardless of the manipulated area, reported an immediate increase in mechanosensitivity over the radial (both sides) and left ulnar nerve trunks (Ppain perception over the radial nerve also improved (P≤0.025). Low-cervical and upper-thoracic thrust manipulation is no more effective than placebo to induce immediate changes on mechanosensitivity of upper limb nerve trunks and grip strength in patients with chronic non-specific mechanical neck pain. A single

Efficacy of Positive Thinking Training on the Family Process and Subjective Wellbeing of Female Heads of Household

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محمد خدایاری فرد

2017-03-01

Full Text Available The present study was designed to investigate the efficacy of positive thinking training on family process and subjective wellbeing of female heads of household. The method was a semi-experimental with pretest-posttest and control group; and the study population included all female heads of household residing in Chaharbagh, Alborz province, who have at least one primary school-kid.  Using available sampling method, 50 women were selected among school-students’ mothers, and were randomly assigned into two equal groups of experimental and control groups. Both groups filled Self-Report Family Process Scale (SFPS and Subjective Wellbeing Questionnaire (SWQ. The experimental group received positive thinking training for eight 2-hours-sessions. Then, all participants were assessed again as the posttest. The data were analyzed by covariance analysis method. Findings showed that after the intervention family process scores of experimental group had been significantly improved, while subjective wellbeing scores had not significantly enhanced. Therefore, it can be told that the present program was effective in increasing the family process, though it went ineffective in improving subjective wellbeing in these irritable individuals. Thus, altering and enriching the program and conducting further investigations seems necessary.

Random walks, random fields, and disordered systems

CERN Document Server

Černý, Jiří; Kotecký, Roman

2015-01-01

Focusing on the mathematics that lies at the intersection of probability theory, statistical physics, combinatorics and computer science, this volume collects together lecture notes on recent developments in the area. The common ground of these subjects is perhaps best described by the three terms in the title: Random Walks, Random Fields and Disordered Systems. The specific topics covered include a study of Branching Brownian Motion from the perspective of disordered (spin-glass) systems, a detailed analysis of weakly self-avoiding random walks in four spatial dimensions via methods of field theory and the renormalization group, a study of phase transitions in disordered discrete structures using a rigorous version of the cavity method, a survey of recent work on interacting polymers in the ballisticity regime and, finally, a treatise on two-dimensional loop-soup models and their connection to conformally invariant systems and the Gaussian Free Field. The notes are aimed at early graduate students with a mod...

Auditory detection of an increment in the rate of a random process

International Nuclear Information System (INIS)

Brown, W.S.; Emmerich, D.S.

1994-01-01

Recent experiments have presented listeners with complex tonal stimuli consisting of components with values (i.e., intensities or frequencies) randomly sampled from probability distributions [e.g., R. A. Lutfi, J. Acoust. Soc. Am. 86, 934--944 (1989)]. In the present experiment, brief tones were presented at intervals corresponding to the intensity of a random process. Specifically, the intervals between tones were randomly selected from exponential probability functions. Listeners were asked to decide whether tones presented during a defined observation interval represented a ''noise'' process alone or the ''noise'' with a ''signal'' process added to it. The number of tones occurring in any observation interval is a Poisson variable; receiver operating characteristics (ROCs) arising from Poisson processes have been considered by Egan [Signal Detection Theory and ROC Analysis (Academic, New York, 1975)]. Several sets of noise and signal intensities and observation interval durations were selected which were expected to yield equivalent performance. Rating ROCs were generated based on subjects' responses in a single-interval, yes--no task. The performance levels achieved by listeners and the effects of intensity and duration are compared to those predicted for an ideal observer

Randomized sham-controlled pilot trial of weekly electro-acupuncture for the prevention of taxane-induced peripheral neuropathy in women with early stage breast cancer.

Science.gov (United States)

Greenlee, Heather; Crew, Katherine D; Capodice, Jillian; Awad, Danielle; Buono, Donna; Shi, Zaixing; Jeffres, Anne; Wyse, Sharon; Whitman, Wendy; Trivedi, Meghna S; Kalinsky, Kevin; Hershman, Dawn L

2016-04-01

To investigate the effect of electro-acupuncture (EA) as a non-pharmacological intervention to prevent or reduce chemotherapy-induced peripheral neuropathy (CIPN) in breast cancer patients undergoing chemotherapy of taxane. Women with stage I-III breast cancer scheduled to receive taxane therapy were randomized to receive a standardized protocol of 12 true or sham EA (SEA) weekly treatments concurrent with taxane treatment. Subjects completed the Brief Pain Inventory-Short Form (BPI-SF), Functional Assessment of Cancer Therapy-Taxane neurotoxicity subscale (FACT-NTX), and other assessments at baseline and weeks 6, 12, and 16. A total of 180 subjects were screened, 63 enrolled and 48 completed week 16 assessments. Mean age was 50 with 25 % white, 25 % black, and 43 % Hispanic; 52 % had no prior chemotherapy. At week 12, both groups reported an increase in mean BPI-SF worst pain score, but no mean differences were found between groups (SEA 2.8 vs. EA 2.6, P = .86). By week 16, the SEA group returned to baseline, while the EA group continued to worsen (SEA 1.7 vs. EA 3.4, P = .03). The increase in BPI-SF worst pain score was 1.62 points higher in the EA group than in the SEA group at week 16 (P = .04). In a randomized, sham-controlled trial of EA for prevention of taxane-induced CIPN, there were no differences in pain or neuropathy between groups at week 12. Of concern, subjects on EA had a slower recovery than SEA subjects. Future studies should focus on EA for treatment as opposed to prevention of CIPN.

A single-dose, crossover, placebo- and moxifloxacin-controlled study to assess the effects of neratinib (HKI-272) on cardiac repolarization in healthy adult subjects.

Science.gov (United States)

Hug, Bruce; Abbas, Richat; Leister, Cathie; Burns, Jaime; Sonnichsen, Daryl

2010-08-01

Neratinib is an orally administered, small-molecule, irreversible pan-ErbB inhibitor in development for the treatment of ErbB2-positive breast cancer. This study assessed the effects of therapeutic and supratherapeutic neratinib concentrations on cardiac repolarization, in accordance with current regulatory guidance. This was a two-part study in healthy subjects. In part 1, subjects were randomized to receive placebo, 400 mg moxifloxacin, or 240 mg neratinib (therapeutic dose) following a high-fat meal. In part 2, after a washout period, subjects received placebo plus 400 mg ketoconazole or 240 mg neratinib plus ketoconazole (supratherapeutic dose). ANOVA was used to compare the baseline-adjusted QTc interval for neratinib with that of placebo (reference), and for neratinib plus ketoconazole with that of placebo plus ketoconazole (reference). Pharmacokinetic/pharmacodynamic analyses and categorical summaries of interval data were done. Assay sensitivity was evaluated by the effect of moxifloxacin on QTc compared with placebo. Sixty healthy subjects were enrolled in this study. The upper bounds of the 90% confidence interval for baseline-adjusted QTcN (population-specific corrected QT) were neratinib. Pharmacokinetic/pharmacodynamic analysis revealed no relationship between neratinib concentrations and QTc interval. No subjects had QTcI, QTcF, or QTcN intervals >450 milliseconds or change from baseline >30 milliseconds. Moxifloxacin produced a significant increase in QTcN compared with placebo (P neratinib do not prolong the QTc interval in healthy subjects. (c) 2010 AACR.

Joint Transmitter-Receiver Optimization in the Downlink CDMA Systems

Directory of Open Access Journals (Sweden)

Mohammad Saquib

2002-08-01

Full Text Available To maximize the downlink code-division multiple access (CDMA system capacity, we propose to minimize the total transmitted power of the system subject to users′ signal-to-interference ratio (SIR requirements via designing optimum transmitter sequences and utilizing linear optimum receivers (minimum mean square error (MMSE receiver. In our work on joint transmitter-receiver design for the downlink CDMA systems with multiple antennas and multipath channels, we develop several optimization algorithms by considering various system constraints and prove their convergence. We empirically observed that under the optimization algorithm with no constraint on the system, the optimum receiver structure matches the received transmitter sequences. A simulation study is performed to see how the different practical system constraints penalize the system with respect to the optimum algorithm with no constraint on the system.

Stepwise withdrawal of inhaled corticosteroids in COPD patients receiving dual bronchodilation

DEFF Research Database (Denmark)

Magnussen, Helgo; Watz, Henrik; Kirsten, Anne

2014-01-01

-controlled fashion, one group of patients continues to receive tiotropium, salmeterol and fluticasone, while the second group initiates stepwise withdrawal of fluticasone. The primary end point is time to first moderate or severe exacerbation following randomized treatment over 52 weeks. Lung function, symptoms...

Control of Lower Extremity Edema in Patients with Diabetes: Double Blind Randomized Controlled Trial Assessing the Efficacy of Mild Compression Diabetic Socks

Science.gov (United States)

Wu, Stephanie C.; Crews, Ryan T.; Skratsky, Melissa; Overstreet, Julia; Yalla, Sai V.; Winder, Michelle; Ortiz, Jacquelyn; Andersen, Charles A.

2017-01-01

Aims Persons with diabetes frequently present with lower extremity (LE) edema; however, compression therapy is generally avoided for fear of compromising arterial circulation in a population with a high prevalence of peripheral arterial disease. This double blind randomized controlled trial (RCT) assessed whether diabetic socks with mild compression could reduce LE edema in patients with diabetes without negatively impacting vascularity. Methods Eighty subjects with LE edema and diabetes were randomized to receive either mild-compression knee high diabetic socks (18–25mmHg) or non-compression knee high diabetic socks. Subjects were instructed to wear the socks during all waking hours. Follow-up visits occurred weekly for four consecutive weeks. Edema was quantified through midfoot, ankle, and calf circumferences and cutaneous fluid measurements. Vascular status was tracked via ankle brachial index (ABI), toe brachial index (TBI), and skin perfusion pressure (SPP). Results Seventy-seven subjects (39 controls and 38 mild-compression subjects) successfully completed the study. No statistical differences between the two groups in terms of age, body mass index, gender, and ethnicity. Repeated measures analysis of variance and Sidak corrections for multiple comparisons were used for data analyses. Subjects randomized to mild-compression diabetic socks demonstrated significant decreases in calf and ankle circumferences at the end of treatment as compared to baseline. LE circulation did not diminish throughout the study with no significant decreases in ABI, TBI or SPP for either group. Conclusions Results of this RCT suggest that mild compression diabetic sock may be effectively and safely used in patients with diabetes and LE edema. PMID:28315576

Small individual loans and mental health: a randomized controlled trial among South African adults.

Science.gov (United States)

Fernald, Lia C H; Hamad, Rita; Karlan, Dean; Ozer, Emily J; Zinman, Jonathan

2008-12-16

In the developing world, access to small, individual loans has been variously hailed as a poverty-alleviation tool - in the context of "microcredit" - but has also been criticized as "usury" and harmful to vulnerable borrowers. Prior studies have assessed effects of access to credit on traditional economic outcomes for poor borrowers, but effects on mental health have been largely ignored. Applicants who had previously been rejected (n = 257) for a loan (200% annual percentage rate - APR) from a lender in South Africa were randomly assigned to a "second-look" that encouraged loan officers to approve their applications. This randomized encouragement resulted in 53% of applicants receiving a loan they otherwise would not have received. All subjects were assessed 6-12 months later with questions about demographics, socio-economic status, and two indicators of mental health: the Center for Epidemiologic Studies - Depression Scale (CES-D) and Cohen's Perceived Stress scale. Intent-to-treat analyses were calculated using multinomial probit regressions. Randomization into receiving a "second look" for access to credit increased perceived stress in the combined sample of women and men; the findings were stronger among men. Credit access was associated with reduced depressive symptoms in men, but not women. Our findings suggest that a mechanism used to reduce the economic stress of extremely poor individuals can have mixed effects on their experiences of psychological stress and depressive symptomatology. Our data support the notion that mental health should be included as a measure of success (or failure) when examining potential tools for poverty alleviation. Further longitudinal research is needed in South Africa and other settings to understand how borrowing at high interest rates affects gender roles and daily life activities. CCT: ISRCTN 10734925.

Post-operative neuromuscular function of patients receiving non ...

African Journals Online (AJOL)

Objectives: To determine the number of patients whose non-depolarising muscle relaxation is adequately reversed. To define factors that contribute to reversal. Design: A cross sectional study. Setting: Universitas Hospital recovery room over a 2 month period. Subjects: Patients that received non-depolarising muscle ...

Ferulic Acid Supplementation Improves Lipid Profiles, Oxidative Stress, and Inflammatory Status in Hyperlipidemic Subjects: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Directory of Open Access Journals (Sweden)

Akkarach Bumrungpert

2018-06-01

Full Text Available Ferulic acid is the most abundant phenolic compound found in vegetables and cereal grains. In vitro and animal studies have shown ferulic acid has anti-hyperlipidemic, anti-oxidative, and anti-inflammatory effects. The objective of this study is to investigate the effects of ferulic acid supplementation on lipid profiles, oxidative stress, and inflammatory status in hyperlipidemia. The study design is a randomized, double-blind, placebo-controlled trial. Subjects with hyperlipidemia were randomly divided into two groups. The treatment group (n = 24 was given ferulic acid (1000 mg daily and the control group (n = 24 was provided with a placebo for six weeks. Lipid profiles, biomarkers of oxidative stress and inflammation were assessed before and after the intervention. Ferulic acid supplementation demonstrated a statistically significant decrease in total cholesterol (8.1%; p = 0.001, LDL-C (9.3%; p < 0.001, triglyceride (12.1%; p = 0.049, and increased HDL-C (4.3%; p = 0.045 compared with the placebo. Ferulic acid also significantly decreased the oxidative stress biomarker, MDA (24.5%; p < 0.001. Moreover, oxidized LDL-C was significantly decreased in the ferulic acid group (7.1%; p = 0.002 compared with the placebo group. In addition, ferulic acid supplementation demonstrated a statistically significant reduction in the inflammatory markers hs-CRP (32.66%; p < 0.001 and TNF-α (13.06%; p < 0.001. These data indicate ferulic acid supplementation can improve lipid profiles and oxidative stress, oxidized LDL-C, and inflammation in hyperlipidemic subjects. Therefore, ferulic acid has the potential to reduce cardiovascular disease risk factors.

The impact of health literacy, patient-centered communication and shared decision-making on patients' satisfaction with care received in German primary care practices.

Science.gov (United States)

Altin, Sibel Vildan; Stock, Stephanie

2016-08-30

Findings on the association between health literacy skills and patient-reported outcomes such as satisfaction with health care delivery are scarce. We explored the extent to which subjective health literacy skills and the perception of the application of patient-centered communication and shared decision-making are associated with patient's satisfaction with care received by their general practitioner (GP). A nationwide cross sectional survey was administered in a random sample of 1125 German adults. A binary logistic regression model controlling for demographics and health status was used to examine the independent contributions of predictor variables (i.e. subjective health literacy, shared decision-making, patient-centered communication) on satisfaction with care received by the GP. Respondents with sufficient health literacy skills were 2.06 times as likely (95 % [CI]: 1.002-4.264) and those who were involved in shared decision-making by their GP were 4.02 times as likely (95 % [CI]: 1.849-8.744) to be satisfied with care received by their GP. Respondents who experienced that their GP explained things in an easy to understand way (OR: 4.44; 95 % [CI]: 1.817-10.869), knew important things about their medical history (OR: 3.46; 95 % [CI]: 1.502-7.994) and spent enough time with them, also reported to be more satisfied (OR: 3.12; 95 % [CI]: 1.410-6.905). German adults having sufficient subjective health literacy skills and experiencing a more patient-centered relationship with their GP are more likely to be satisfied with care. These findings are important for health care organizations aiming to respond to health literacy needs of patients.

Comparison of glucosamine sulfate and a polyherbal supplement for the relief of osteoarthritis of the knee: a randomized controlled trial [ISRCTN25438351

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Modak Millind

2007-10-01

Full Text Available Abstract Background The efficacy and safety of a dietary supplement derived from South American botanicals was compared to glucosamine sulfate in osteoarthritis subjects in a Mumbai-based multi-center, randomized, double-blind study. Methods Subjects (n = 95 were screened and randomized to receive glucosamine sulfate (n = 47, 1500 mg/day or reparagen (n = 48, 1800 mg/day, a polyherbal consisting of 300 mg of vincaria (Uncaria guianensis and 1500 mg of RNI 249 (Lepidium meyenii administered orally, twice daily. Primary efficacy variable was response rate based on a 20% improvement in WOMAC pain scores. Additional outcomes were WOMAC scores for pain, stiffness and function, visual analog score (VAS for pain, with assessments at 1, 2, 4, 6 and 8 weeks. Tolerability, investigator and subject global assessments and rescue medication consumption (paracetamol were measured together with safety assessments including vital signs and laboratory based assays. Results Subject randomization was effective: age, gender and disease status distribution was similar in both groups. The response rates (20% reduction in WOMAC pain were substantial for both glucosamine (89% and reparagen (94% and supported by investigator and subject assessments. Using related criteria response rates to reparagen were favorable when compared to glucosamine. Compared to baseline both treatments showed significant benefits in WOMAC and VAS outcomes within one week (P Conclusion Both reparagen and glucosamine sulfate produced substantial improvements in pain, stiffness and function in subjects with osteoarthritis. Response rates were high and the safety profile was excellent, with significantly less rescue medication use with reparagen. Reparagen represents a new natural productive alternative in the management of joint health. Trial registration Current Controlled Trials ISRCTN25438351.

Random vibrations theory and practice

CERN Document Server

Wirsching, Paul H; Ortiz, Keith

1995-01-01

Random Vibrations: Theory and Practice covers the theory and analysis of mechanical and structural systems undergoing random oscillations due to any number of phenomena— from engine noise, turbulent flow, and acoustic noise to wind, ocean waves, earthquakes, and rough pavement. For systems operating in such environments, a random vibration analysis is essential to the safety and reliability of the system. By far the most comprehensive text available on random vibrations, Random Vibrations: Theory and Practice is designed for readers who are new to the subject as well as those who are familiar with the fundamentals and wish to study a particular topic or use the text as an authoritative reference. It is divided into three major sections: fundamental background, random vibration development and applications to design, and random signal analysis. Introductory chapters cover topics in probability, statistics, and random processes that prepare the reader for the development of the theory of random vibrations a...

Random queues and risk averse users

DEFF Research Database (Denmark)

de Palma, André; Fosgerau, Mogens

2013-01-01

We analyze Nash equilibrium in time of use of a congested facility. Users are risk averse with general concave utility. Queues are subject to varying degrees of random sorting, ranging from strict queue priority to a completely random queue. We define the key “no residual queue” property, which...

Performance on a probabilistic inference task in healthy subjects receiving ketamine compared with patients with schizophrenia

Science.gov (United States)

Almahdi, Basil; Sultan, Pervez; Sohanpal, Imrat; Brandner, Brigitta; Collier, Tracey; Shergill, Sukhi S; Cregg, Roman; Averbeck, Bruno B

2012-01-01

Evidence suggests that some aspects of schizophrenia can be induced in healthy volunteers through acute administration of the non-competitive NMDA-receptor antagonist, ketamine. In probabilistic inference tasks, patients with schizophrenia have been shown to ‘jump to conclusions’ (JTC) when asked to make a decision. We aimed to test whether healthy participants receiving ketamine would adopt a JTC response pattern resembling that of patients. The paradigmatic task used to investigate JTC has been the ‘urn’ task, where participants are shown a sequence of beads drawn from one of two ‘urns’, each containing coloured beads in different proportions. Participants make a decision when they think they know the urn from which beads are being drawn. We compared performance on the urn task between controls receiving acute ketamine or placebo with that of patients with schizophrenia and another group of controls matched to the patient group. Patients were shown to exhibit a JTC response pattern relative to their matched controls, whereas JTC was not evident in controls receiving ketamine relative to placebo. Ketamine does not appear to promote JTC in healthy controls, suggesting that ketamine does not affect probabilistic inferences. PMID:22389244

Prospective, randomized study of one, two, or three trabecular bypass stents in open-angle glaucoma subjects on topical hypotensive medication

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Katz LJ

2015-12-01

Full Text Available L Jay Katz,1 Carl Erb,2 Amadeu Carceller Guillamet,3 Antonio M Fea,4 Lilit Voskanyan,5 Jeffrey M Wells,6 Jane Ellen Giamporcaro6 1Wills Eye Hospital, Jefferson Medical College, Philadelphia, PA, USA; 2Eye Clinic Wittenbergplatz, Berlin, Germany; 3Department of Ophthalmology, Hospital d’Hebron, Barcelona, Spain; 4University Eye Clinic of the University of Turin, Turin, Italy; 5SV Malayan Opthalmology Centre, Yerevan, Armenia; 6Glaukos Corporation, Laguna Hills, CA, USA Purpose: To assess the safety and efficacy of one, two, or three trabecular microbypass stents in eyes with primary open-angle glaucoma (OAG not controlled on ocular hypotensive medication. A total of 119 subjects were followed for 18 months postoperatively.Materials and methods: Subjects with medicated intraocular pressure (IOP 18–30 mmHg and postmedication-washout baseline IOP 22–38 mmHg were randomized to implantation of one, two, or three stents. Ocular hypotensive medication was to be used if postoperative IOP exceeded 18 mmHg.Results: A total of 38 subjects were implanted with one stent, 41 subjects with two stents, and 40 subjects with three stents. Both month 12 IOP reduction ≥20% without ocular hypotensive medication vs baseline unmedicated IOP and month 12 unmedicated IOP ≤18 mmHg were achieved by 89.2%, 90.2%, and 92.1% of one-, two-, and three-stent eyes, respectively. Furthermore, 64.9%, 85.4%, and 92.1% of the three respective groups achieved unmedicated IOP ≤15 mmHg. Over the 18-month follow-up period, medication was required in seven one-stent subjects, four two-stent subjects, and three three-stent subjects. At 18 months, mean unmedicated IOP was 15.9±0.9 mmHg in one-stent subjects, 14.1±1.0 mmHg in two-stent subjects, and 12.2±1.1 mmHg in three-stent subjects. Month 18 IOP reduction was significantly greater (P<0.001 with implantation of each additional stent, with mean differences in reduction of 1.84 mmHg (95% confidence interval 0.96�

Effectiveness of acupuncture therapy as treatment for tinnitus: a randomized controlled trial

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Marcelo Yugi Doi

Full Text Available ABSTRACT INTRODUCTION: Tinnitus is a subjective sensation of hearing a sound in the absence of an external stimulus, which significantly worsens the quality of life in 15-25% of affected individuals. OBJECTIVE: To assess the effectiveness of acupuncture therapy for tinnitus. METHODS: Randomized clinical trial (REBEC: 2T9T7Q with 50 participants with tinnitus, divided into two groups: 25 participants in the acupuncture group and 25 participants in the control group. The acupuncture group received acupuncture treatment and the control group received no treatment. After a period of 5 weeks, they were called to perform the final evaluation and the control group received acupuncture treatment for ethical reasons. RESULTS: A statistically significant result was found for the primary outcome, reducing the intensity of tinnitus, with p = 0.0001 and the secondary endpoint, showing improvement in quality of life, with p = 0.0001. CONCLUSION: Chinese scalp acupuncture associated with bilateral electroacupuncture demonstrated, in the short term, a statistically significant improvement by reducing the level of tinnitus intensity, as well as improving the quality of life of individuals with tinnitus.

Effectiveness of acupuncture therapy as treatment for tinnitus: a randomized controlled trial.

Science.gov (United States)

Doi, Marcelo Yugi; Tano, Simone Sayomi; Schultz, Adriane Rocha; Borges, Ricardo; Marchiori, Luciana Lozza de Moraes

2016-01-01

Tinnitus is a subjective sensation of hearing a sound in the absence of an external stimulus, which significantly worsens the quality of life in 15-25% of affected individuals. To assess the effectiveness of acupuncture therapy for tinnitus. Randomized clinical trial ( 2T9T7Q) with 50 participants with tinnitus, divided into two groups: 25 participants in the acupuncture group and 25 participants in the control group. The acupuncture group received acupuncture treatment and the control group received no treatment. After a period of 5 weeks, they were called to perform the final evaluation and the control group received acupuncture treatment for ethical reasons. A statistically significant result was found for the primary outcome, reducing the intensity of tinnitus, with p=0.0001 and the secondary endpoint, showing improvement in quality of life, with p=0.0001. Chinese scalp acupuncture associated with bilateral electroacupuncture demonstrated, in the short term, a statistically significant improvement by reducing the level of tinnitus intensity, as well as improving the quality of life of individuals with tinnitus. Copyright © 2016 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

Absorbed doses received by infants subjected to panoramic dental and cephalic radiographs

International Nuclear Information System (INIS)

Carrizales, L.; Carreno, S.

1998-01-01

The IAEA Report No. 115 recommends that each country or region can establish levels of absorbed doses for each radiographic technique employed in diagnostic. assuming the extended and expensive of this purpose, we have been to begin in a first step with the dentistry area, in order to estimate the dose levels received at crystalline and thyroid level in infants that go to an important public institution in our country to realize panoramic and cephalic radiographs. This work will serve to justify and impel a quality assurance program in Venezuela on the dentistry area which includes aspects such as training for the medical lap referring the justification of the radiological practice, optimization of X-ray units to produce an adequate image quality that delivers to patient an absorbed dose as much lower as reasonably it can be reached without diagnostic detriment. (Author)

Dry eye, sleep quality, and mood status in glaucoma patients receiving prostaglandin monotherapy were comparable with those in non-glaucoma subjects.

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Shugyoku Ra

Full Text Available Prior studies suggested that glaucoma patients suffer worse dry eye and mood and sleep disorders than non-glaucoma subjects. Prostaglandin analogues are first-line therapy for glaucoma, inducing few instillation problems and sufficient pressure-reduction effects. This study compared dry eye, sleep quality, and mood status between glaucoma patients receiving prostaglandin monotherapy and non-glaucoma subjects.This cross-sectional study evaluated 1520 patients (579 males and 941 females for glaucoma status and dry eye-related symptoms (dryness, eye fatigue, photophobia, pain, blurring and signs (Schirmer test, tear break-up time, corneal staining scores. Of the total cohort, 93 patients were also evaluated by Pittsburgh sleep quality index (PSQI and hospital anxiety and depression score (HADS. Inclusion criteria were consecutive patients ≥ 51 years of age and best-corrected visual acuity ≥ 20/25. Glaucoma patients included those treated with prostaglandin or a fixed combination including prostaglandin. Exclusion criteria were history of ocular surgery within one month. Data were analyzed using the chi-square or Mann-Whitney U tests, at 5% significance.There were no significant differences in dry eye-related signs and symptoms between the control (n = 1431, mean age of 66.9 years and glaucoma groups (n = 89, 67.9 years. The psychiatric sub-analysis of the control (n = 61, 66.2 years and glaucoma groups (n = 32, 67.3 years revealed mean scores of 5.02 ± 3.10 and 5.16 ± 3.46 for PSQI (normal range ≤ 5, 9.47 ± 5.61 and 9.42 ± 7.36 for HADS (normal range ≤ 10, 4.84 ± 3.22 and 4.71 ± 3.45 for anxiety (normal range ≤ 5, and 4.63 ± 3.05 and 4.71 ± 4.40 for depression (normal range ≤ 5, respectively, without statistical significance.Our results were comparable between glaucoma patients on prostaglandin monotherapy and non-glaucoma subjects for dry eye-related clinical manifestations, sleep quality, and mood status.

The pharmacokinetics of artemisinin after administration of two different suppositories to healthy Vietnamese subjects

NARCIS (Netherlands)

Koopmans, R.; Ha, L. D.; Duc, D. D.; Dien, T. K.; Kager, P. A.; Khanh, N. X.; van Boxtel, C. J.; de Vries, P. J.

1999-01-01

Eight healthy Vietnamese male subjects received 400 mg artemisinin formulated into fatty suppositories (FS), and six different subjects received 500 mg of artemisinin formulated in polyethylene glycol suppositories (PEGS). Plasma concentrations were measured by high-performance liquid chromatography

EFFECTIVENESS OF A NEW BALANCE TRAINING PROGRAM ON ROCKER BOARD IN SITTING IN STROKE SUBJECTS A PILOT STUDY

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Sandesh Rayamajhi

2014-06-01

Full Text Available Background: Stroke has been considered to be the most common cause of neurological disability with very high prevalence rate. The recovery of independence following stroke is a complex process requiring the reacquisition of many skills. Since controlling the body’s position in space is essential part of functional skills, restoration of balance is a critical part of the recovery of ability after stroke. Most of the work done regarding balance training in stroke subjects has focused on task-oriented activities and training under varied sensory input and found them to be effective. Studies have also compared the effect of stable and unstable surfaces on balance in stroke subjects and found that balance training on unstable surfaces is more effective in improving static and dynamic balance. There has not been any study till date investigating the effectiveness of balance training program on rocker board which is specific for stroke subjects who have difficulty in standing. Since balance training on rocker board in sitting has proved to be effective in improving balance in subjects with spinal cord injury who have difficulty in standing, there is a need to find out if similar balance training program on rocker board in sitting is also effective for improving balance of stroke subjects. Method: A Pilot study was performed on 10 stroke subjects selected through purposive sampling. Subjects were divided into two groups by randomization as control (CG and experimental group (EG. EG received balance training on a rocker board along with conventional physiotherapy program. The CG received only conventional physiotherapy program. Results: Post-intervention Berg balance scale score of EG and the CG was statistically significant (p < 0.05 in both the groups as compared to pre-treatment depicted through Wilcoxon signed rank analysis within the groups. Greater improvement was observed in the EG compared to the CG post-treatment, analysed through Mann

A randomized double-blind study of testosterone replacement therapy or placebo in testicular cancer survivors with mild Leydig cell insufficiency (Einstein-intervention).

Science.gov (United States)

Bandak, Mikkel; Jørgensen, Niels; Juul, Anders; Lauritsen, Jakob; Kreiberg, Michael; Oturai, Peter Sandor; Helge, Jørn Wulff; Daugaard, Gedske

2017-07-03

Elevated serum levels of luteinizing hormone and slightly decreased serum levels of testosterone (mild Leydig cell insufficiency) is a common hormonal disturbance in testicular cancer (TC) survivors. A number of studies have shown that low serum levels of testosterone is associated with low grade inflammation and increased risk of metabolic syndrome. However, so far, no studies have evaluated whether testosterone substitution improves metabolic dysfunction in TC survivors with mild Leydig cell insufficiency. This is a single-center, randomized, double-blind, placebo-controlled study, designed to evaluate the effect of testosterone replacement therapy in TC survivors with mild Leydig cell insufficiency. Seventy subjects will be randomized to receive either testosterone replacement therapy or placebo. The subjects will be invited for an information meeting where informed consent will be obtained. Afterwards, a 52-weeks treatment period begins in which study participants will receive a daily dose of transdermal testosterone or placebo. Dose adjustment will be made three times during the initial 8 weeks of the study to a maximal daily dose of 40 mg of testosterone in the intervention arm. Evaluation of primary and secondary endpoints will be performed at baseline, 26 weeks post-randomization, at the end of treatment (52 weeks) and 3 months after completion of treatment (week 64). This study is the first to investigate the effect of testosterone substitution in testicular cancer survivors with mild Leydig cell insufficiency. If positive, it may change the clinical handling of testicular cancer survivors with borderline low levels of testosterone. ClinicalTrials.gov : NCT02991209 (November 25, 2016).

Subject-centered free-response ROC (FROC) analysis

OpenAIRE

Bandos, Andriy I.; Rockette, Howard E.; Gur, David

2013-01-01

Purpose: To develop an approach of estimating subject-centered free-response receiver operating characteristic (FROC) curve for providing patient-centered inferences regarding detection-localization characteristics of a diagnostic system.

THE EFFECTIVENESS OF EMG BIOFEEDBACK ON HAND FUNCTION IN SUBJECTS WITH STROKE

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S. Sethana

2014-10-01

Full Text Available Introduction: Stroke is an event caused by the interruption of the blood supply to the brain, usually because a blood vessel bursts or blocked by a clot. Biofeedback can be defined as the technique of using equipment usually electronic to reveal to human beings about some of their internal physiological events normal and abnormal in form of auditory and visual signals. Method: The stroke patients diagnosed by neurologist were recruited from physiotherapy department and inpatients from neurology and general wards of SVIMS hospital, Tirupathi Andhra Pradesh. In the present study 30 subjects were randomly assigned to 15 experimental and 15 control groups. The subject was made to sit comfortably and the Surfaces electrodes were placed on Extensor carpi radialis, Extensor digitorum communis muscle belly and for 30minutes patient voluntarily contracts until signals displayed on screen for which visually and auditory cues are given. In control group placebo EMG where machine is turned away & has no cues. Both groups received CONVENTIONAL PHYSIOTHERAPY; for 30 minutes at a Frequency: 1 hour per day for 5days in a week, for 6weeks. Results: There was statistically significant (p<0.05 improvement in both variables from baseline to 6thweek in experimental group compared to control group. Conclusion: Our study demonstrates the potential benefits of EMG BF in improving hand function in subjects with stroke.

Vapocoolant Anesthesia for Cosmetic Facial Rejuvenation Injections: A Randomized, Prospective, Split-Face Trial.

Science.gov (United States)

Zeiderman, Matthew R; Kelishadi, Shahrooz Sean; Tutela, John Paul; Rao, Arun; Chowdhry, Saeed; Brooks, Ronald M; Wilhelmi, Bradon J

2018-01-01

Background: Minimally invasive cosmetic procedures are the most commonly performed aesthetic techniques by plastic surgeons. Patients are interested in a pain-free experience. Surgeons desire patient satisfaction and time-efficient utilization of office staff and resources. Clinical evidence exists for use of vapocoolant technology to reduce pain associated with intravenous cannulation in the pediatric population and in hemodialysis patients. Applying vapocoolant technology to facial rejuvenation is a novel approach to decrease pain associated with neurotoxin or filler injection. Methods: A randomized, prospective study was conducted, testing 15 subjects receiving filler injections and another 15 patients receiving neurotoxin injections using a split-face model. The vapocoolant spray used was composed of a 95:5 ratio of 1,1,1,3,3-pentafluoropropane and 1,1,1,2-tetrafluoroethane. Within each group, individual patients randomly received injection (filler or neurotoxin) alone versus injection (filler or neurotoxin) plus vapocoolant on an equivalent half of his or her face. An independent examiner recorded from each patient on a scale of 1 to 10 perceived pain for injection alone versus injection plus vapocoolant spray. Results were calculated as a percentage change of pain scores experienced after injection for each person between the control (nonvapocoolant) and treatment (vapocoolant) sides of the face. Results: Vapocoolant spray at the time of cosmetic facial injections leads to a 59% decrease in perceived pain score with neurotoxin injections (range, 0%-100% change) and 64% decrease in perceived pain score with filler injections (range, 0%-100% change). These results were statistically significant with P reduces pain associated with facial rejuvenation procedures.

Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial

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Nuria eRuffini

2015-08-01

Full Text Available Context: Heart Rate Variability (HRV indicates how heart rate changes in response to inner and external stimuli. HRV is linked to health status and it is an indirect marker of the autonomic nervous system (ANS function. Objective: To investigate the influence of osteopathic manipulative treatment (OMT on ANS activity through changes of High Frequency, a heart rate variability index indicating the parasympathetic activity, in healthy subjects, compared with sham therapy and control group.Methods: Sixty-six healthy subjects, both male and female, were included in the present 3-armed randomized placebo controlled within subject cross-over single blinded study. Participants were asymptomatic adults, both smokers and non-smokers and not on medications. At enrollment subjects were randomized in 3 groups: A, B, C. Standardized structural evaluation followed by a patient need-based osteopathic treatment was performed in the first session of group A and in the second session of group B. Standardized evaluation followed by a protocoled sham treatment was provided in the second session of group A and in the first session of group B. No intervention was performed in the two sessions of group C, acting as a time-control. The trial was registered on clinicaltrials.gov identifier: NCT01908920.Main Outcomes Measures: HRV was calculated from electrocardiography before, during and after the intervention, for a total amount time of 25 minutes.Results: OMT engendered a statistically significant increase of parasympathetic activity, as shown by High Frequency rate (p<0.001, and decrease of sympathetic activity, as revealed by Low Frequency rate (p<0.01; results also showed a reduction of Low Frequency/High Frequency ratio (p<0.001 and Detrended fluctuation scaling exponent (p<0.05. Conclusions: Findings suggested that OMT can influence ANS activity increasing parasympathetic function and decreasing sympathetic activity, compared to sham therapy and control group.

Metabolic and Inflammatory Changes with Orlistat and Sibutramine Treatment in Obese Malaysian Subjects.

Science.gov (United States)

Al-Tahami, Belqes Abdullah Mohammad; Al-Safi Ismail, Ab Aziz; Sanip, Zulkefli; Yusoff, Zurkurnai; Shihabudin, Tg Muzaffar Tm; Singh, Taran Singh Pall; Rasool, Aida Hanum Ghulam

2017-01-01

Obesity is associated with numerous health problems, particularly metabolic and cardiovascular complications. This study aimed to assess the effects that, nine months of pharmacological intervention with orlistat or sibutramine, on obese Malaysians' body weight and compositions, metabolic profiles and inflammatory marker. Seventy-six obese subjects were randomly placed into two groups. The first group received three daily 120 mg dosages of orlistat for nine months (n=39), and the second group received a once daily 10 or 15 mg dosage of sibutramine for nine months (n=37). Baseline measurements for weight, body mass index (BMI), waist circumference (WC), body fat percentage (BF), visceral fat (VF), adiponectin, fasting plasma glucose (FPG), fasting insulin, pancreatic B cell secretory capacity (HOMA%B), insulin sensitivity (HOMA%S), insulin resistance (HOMA-IR) and serum high sensitivity C-reactive protein (hs-CRP) were performed and repeated during the sixth and ninth months of treatment. Twenty-four subjects completed the trial in both groups. For both groups, weight, BMI, WC, BF, VF, HOMA-IR and hs-CRP were significantly lower at the end of the nine month intervention. However, there were no significant differences between the two groups for these parameters with nine months treatment. There was a significant decrease in FPG in orlistat group; while fasting insulin and HOMA%B reduced in sibutramine group. For both groups, there were also significant increases in adiponectin levels and HOMA%S at the end of the nine month intervention. Nine months of treatment with orlistat and sibutramine not only reduced weight but also significantly improved BMI, WC, BF, VF, FPG, adiponectin, fasting insulin, HOMA%B, HOMA%S, HOMA-IR and hs-CRP. These improvements could prove useful in the reduction of metabolic and cardiovascular risks in obese subjects.

Switching from rivaroxaban to warfarin: an open label pharmacodynamic study in healthy subjects

Science.gov (United States)

Moore, Kenneth Todd; Byra, William; Vaidyanathan, Seema; Natarajan, Jaya; Ariyawansa, Jay; Salih, Hiba; Turner, Kenneth C

2015-01-01

Aims The primary objective was to explore the pharmacodynamic changes during transition from rivaroxaban to warfarin in healthy subjects. Safety, tolerability and pharmacokinetics were assessed as secondary objectives. Methods An open label, non-randomized, sequential two period study. In treatment period 1 (TP1), subjects received rivaroxaban 20 mg once daily (5 days), followed by co-administration with a warfarin loading dose regimen of 5 or 10 mg (for the 10 mg regimen, the dose could be uptitrated to attain target international normalized ratio [INR] ≥2.0) once daily (2–4 days). When trough INR values ≥2.0 were attained, rivaroxaban was discontinued and warfarin treatment continued as monotherapy (INR 2.0–3.0). During treatment period 2, subjects received the same warfarin regimen as in TP1, but without rivaroxaban. Results During co-administration, maximum INR and prothrombin time (PT) values were higher than with rivaroxaban or warfarin monotherapy. The mean maximum effect (Emax) for INR after co-administration was 2.79–4.15 (mean PT Emax 41.0–62.7 s), compared with 1.41–1.74 (mean PT Emax 20.1–25.2 s) for warfarin alone. However, rivaroxaban had the smallest effect on INR at trough rivaroxaban concentrations. Neither rivaroxaban nor warfarin significantly affected maximum plasma concentrations of the other drug. Conclusions The combined pharmacodynamic effects during co-administration of rivaroxaban and warfarin were greater than additive, but the pharmacokinetics of both drugs were unaffected. Co-administration was well tolerated. When transitioning from rivaroxaban to warfarin, INR monitoring during co-administration should be performed at the trough rivaroxaban concentration to minimize the effect of rivaroxaban on INR. PMID:25475601

Receiver gain function: the actual NMR receiver gain

OpenAIRE

Mo, Huaping; Harwood, John S.; Raftery, Daniel

2010-01-01

The observed NMR signal size depends on the receiver gain parameter. We propose a receiver gain function to characterize how much the raw FID is amplified by the receiver as a function of the receiver gain setting. Although the receiver is linear for a fixed gain setting, the actual gain of the receiver may differ from what the gain setting suggests. Nevertheless, for a given receiver, we demonstrate that the receiver gain function can be calibrated. Such a calibration enables accurate compar...

The effect of 5 intravenous lipid emulsions on plasma phytosterols in preterm infants receiving parenteral nutrition: a randomized clinical trial.

Science.gov (United States)

Savini, Sara; D'Ascenzo, Rita; Biagetti, Chiara; Serpentini, Giulia; Pompilio, Adriana; Bartoli, Alice; Cogo, Paola E; Carnielli, Virgilio P

2013-08-01

Elevated plasma phytosterol concentrations are an untoward effect of parenteral nutrition (PN) with vegetable oil-based lipid emulsions (LEs). Phytosterols are elevated in neonatal cholestasis, but the relation remains controversial. The objective was to study the effect of 5 LEs on plasma phytosterols in preterm infants. One hundred forty-four consecutive admitted preterm infants (birth weight: 500-1249 g) were studied. Patients were randomly assigned to receive 1 of 5 different LEs: S [100% soybean oil (SO)], MS [50% medium-chain triglycerides (MCTs) and 50% SO], MSF (50% MCTs, 40% SO, and 10% fish oil (FO)], OS (80% olive oil and 20% SO), or MOSF (30% MCTs, 25% olive oil, 30% SO, and 15% FO). Phytosterols in the LEs and in plasma (on postnatal day 7 and day 14) were measured by gas chromatography-mass spectrometry. Patients in the S group had significantly higher total phytosterol intakes than did the other study groups. On PN days 7 and 14, plasma phytosterol concentrations were highest in the S group and lowest in the MOSF group. Despite similar β-sitosterol intakes between the MS and MSF groups, plasma concentrations were significantly lower in the MSF than in the MS group. Only 3 patients (2.1%) developed cholestasis: 1 in the MS, 1 in the MSF, and 1 in the MOSF group. No cases of cholestasis were observed in the S and OS groups. In uncomplicated preterm infants receiving routine PN, we found a correlation between phytosterol intake and plasma phytosterol concentrations; however, cholestasis was rare and no difference in liver function at 6 wk was observed.

A Randomized Controlled Trial of Intravenous Haloperidol vs. Intravenous Metoclopramide for Acute Migraine Therapy in the Emergency Department.

Science.gov (United States)

Gaffigan, Matthew E; Bruner, David I; Wason, Courtney; Pritchard, Amy; Frumkin, Kenneth

2015-09-01

Emergency Department (ED) headache patients are commonly treated with neuroleptic antiemetics like metoclopramide. Haloperidol has been shown to be effective for migraine treatment. Our study compared the use of metoclopramide vs. haloperidol to treat ED migraine patients. A prospective, double-blinded, randomized control trial of 64 adults aged 18-50 years with migraine headache and no recognized risks for QT-prolongation. Haloperidol 5 mg or metoclopramide 10 mg was given intravenously after 25 mg diphenhydramine. Pain, nausea, restlessness (akathisia), and sedation were assessed with 100-mm visual analog scales (VAS) at baseline and every 20 min, to a maximum of 80 min. The need for rescue medications, side effects, and subject satisfaction were recorded. QTc intervals were measured prior to and after treatment. Follow-up calls after 48 h assessed satisfaction and recurrent or persistent symptoms. Thirty-one subjects received haloperidol, 33 metoclopramide. The groups were similar on all VAS measurements, side effects, and in their satisfaction with therapy. Pain relief averaged 53 mm VAS over both groups, with equal times to maximum improvement. Subjects receiving haloperidol required rescue medication significantly less often (3% vs. 24%, p haloperidol-treated subjects experiencing more restlessness (43% vs. 10%). Intravenous haloperidol is as safe and effective as metoclopramide for the ED treatment of migraine headaches, with less frequent need for rescue medications. Published by Elsevier Inc.

Acute effect of Clitoria ternatea flower beverage on glycemic response and antioxidant capacity in healthy subjects: a randomized crossover trial.

Science.gov (United States)

Chusak, Charoonsri; Thilavech, Thavaree; Henry, Christiani Jeyakumar; Adisakwattana, Sirichai

2018-01-08

Clitoria ternatea L., a natural food-colorant containing anthocyanin, demonstrated antioxidant and antihyperglycemic activity. The aim of this study was to determine the effects of Clitoria ternatea flower extract (CTE) on postprandial plasma glycemia response and antioxidant status in healthy men. In a randomized, crossover study, 15 healthy men (ages 22.53 ± 0.30 years; with body mass index of 21.57 ± 0.54 kg/m 2 ) consumed five beverages: (1) 50 g sucrose in 400 mL water; (2) 1 g CTE in 400 mL of water; (3) 2 g CTE in 400 mL of water; (4) 50 g sucrose and 1 g CTE in 400 mL of water; and (5) 50 g sucrose and 2 g CTE in 400 mL of water. Incremental postprandial plasma glucose, insulin, uric acid, antioxidant capacities and lipid peroxidation were measured during 3 h of administration. After 30 min ingestion, the postprandial plasma glucose and insulin levels were suppressed when consuming sucrose plus 1 g and 2 g CTE. In addition, consumption of CTE alone did not alter plasma glucose and insulin concentration in the fasting state. The significant increase in plasma antioxidant capacity (ferric reducing ability of plasma (FRAP), oxygen radical absorbance capacity (ORAC), trolox equivalent antioxidant capacity (TEAC), and protein thiol) and the decrease in malondialdehyde (MDA) level were observed in the subjects who received 1 g and 2 g CTE. Furthermore, consumption of CTE protected sucrose-induced reduction in ORAC and TEAC and increase in plasma MDA. These findings suggest that an acute ingestion of CTE increases plasma antioxidant capacity without hypoglycemia in the fasting state. It also improves postprandial glucose, insulin and antioxidant status when consumed with sucrose. Thai Clinical Trials Registry: TCTR20170609003 . Registered 09 September 2017. 'retrospectively registered'.

Random maintenance policies

CERN Document Server

Nakagawa, Toshio

2014-01-01

Exploring random maintenance models, this book provides an introduction to the implementation of random maintenance, and it is one of the first books to be written on this subject.  It aims to help readers learn new techniques for applying random policies to actual reliability models, and it provides new theoretical analyses of various models including classical replacement, preventive maintenance and inspection policies. These policies are applied to scheduling problems, backup policies of database systems, maintenance policies of cumulative damage models, and reliability of random redundant systems. Reliability theory is a major concern for engineers and managers, and in light of Japan’s recent earthquake, the reliability of large-scale systems has increased in importance. This also highlights the need for a new notion of maintenance and reliability theory, and how this can practically be applied to systems. Providing an essential guide for engineers and managers specializing in reliability maintenance a...

Compressed Sensing-Based Direct Conversion Receiver

DEFF Research Database (Denmark)

Pierzchlewski, Jacek; Arildsen, Thomas; Larsen, Torben

2012-01-01

Due to the continuously increasing computational power of modern data receivers it is possible to move more and more processing from the analog to the digital domain. This paper presents a compressed sensing approach to relaxing the analog filtering requirements prior to the ADCs in a direct......-converted radio signals. As shown in an experiment presented in the article, when the proposed method is used, it is possible to relax the requirements for the quadrature down-converter filters. A random sampling device and an additional digital signal processing module is the price to pay for these relaxed...

Chromium supplementation alters the performance, metabolism, and immune response of feedlot cattle during the receiving period

Science.gov (United States)

Crossbreed steers (n = 180; 507 +/- 13 lb) were fed during a 56-d receiving period to determine if supplementing chromium (Cr; KemTRACEbrandChromiumPropionate 0.04%, Kemin Industries) would improve feedlot performance and health of newly received cattle. A completely randomized block design (36 pens...

Exercises focusing on rotator cuff and scapular muscles do not improve shoulder joint position sense in healthy subjects.

Science.gov (United States)

Lin, Yin-Liang; Karduna, Andrew

2016-10-01

Proprioception is essential for shoulder neuromuscular control and shoulder stability. Exercise of the rotator cuff and scapulothoracic muscles is an important part of shoulder rehabilitation. The purpose of this study was to investigate the effect of rotator cuff and scapulothoracic muscle exercises on shoulder joint position sense. Thirty-six healthy subjects were recruited and randomly assigned into either a control or training group. The subjects in the training group received closed-chain and open-chain exercises focusing on rotator cuff and scapulothoracic muscles for four weeks. Shoulder joint position sense errors in elevation, including the humerothoracic, glenohumeral and scapulothoracic joints, was measured. After four weeks of exercise training, strength increased overall in the training group, which demonstrated the effect of exercise on the muscular system. However, the changes in shoulder joint position sense errors in any individual joint of the subjects in the training group were not different from those of the control subjects. Therefore, exercises specifically targeting individual muscles with low intensity may not be sufficient to improve shoulder joint position sense in healthy subjects. Future work is needed to further investigate which types of exercise are more effective in improving joint position sense, and the mechanisms associated with those changes. Copyright © 2016 Elsevier B.V. All rights reserved.

Simultaneous radar and spaced receiver VHF scintillation observations of ESF irregularities

Directory of Open Access Journals (Sweden)

D. Tiwari

2006-07-01

Full Text Available Simultaneous observations of equatorial spread F (ESF irregularities made on 10 nights during March-April 1998 and 1999, using an 18-MHz radar at Trivandrum (77° E, 8.5° N, dip 0.5° N and two spaced receivers recording scintillations on a 251-MHz signal at Tirunelveli (77.8° E, 8.7° N, dip 0.4° N, have been used to study the evolution of Equatorial Spread F (ESF irregularities. Case studies have been carried out on the day-to-day variability in ESF structure and dynamics, as observed by 18-MHz radar, and with spaced receiver measurements of average zonal drift V_o of the 251-MHz radio wave diffraction pattern on the ground, random velocity V_c, which is a measure of random changes in the characteristics of scintillation-producing irregularities, and maximum cross-correlation C_I of the spaced receivers signals. Results show that in the initial phase of plasma bubble development, the greater the maximum height of ESF irregularities responsible for the radar backscatter, the greater the decorrelation is of the spaced receiver scintillation signals, indicating greater turbulence. The relationship of the maximum spectral width derived from the radar observations and C_I also supports this result.

Randomized, double-blind, placebo-controlled study of Malarone for malaria prophylaxis in non-immune Colombian soldiers.

Science.gov (United States)

Soto, Jaime; Toledo, Julia; Luzz, Magda; Gutierrez, Patricia; Berman, Jonathan; Duparc, Stephane

2006-09-01

Malarone was compared with placebo in a double-blind, randomized, placebo-controlled trial of prophylaxis of malaria in predominately Plasmodium vivax areas of Colombia. The study population consisted of 180 completely non-immune Colombian soldiers, male, average age 19 years, and average weight 63 kg. Twenty-four subjects were considered unevaluable because of compliance issues, including one Malarone subject (with no detectable drug levels) who became infected with P. vivax. Of the 97 evaluable subjects who received Malarone (250 mg atovaquone plus 100 mg proguanil hydrochloride) daily from 1 day before entering the endemic area to 7 days after leaving the endemic area, none became parasitemic. Of the 46 evaluable placebo subjects, 11 became infected with P. vivax and 2 became infected with Plasmodium falciparum. The protective efficacy of Malarone for all malaria and for P. vivax malaria was 100% (LL 95% CI = 63%) and 100% (LL 95% CI = 58%), respectively, and was 96% if the one case with undetectable blood levels was included. Malarone has high protective efficacy for P. vivax in Colombia.

Overall Survival in Patients With Advanced Melanoma Who Received Nivolumab Versus Investigator's Choice Chemotherapy in CheckMate 037: A Randomized, Controlled, Open-Label Phase III Trial.

Science.gov (United States)

Larkin, James; Minor, David; D'Angelo, Sandra; Neyns, Bart; Smylie, Michael; Miller, Wilson H; Gutzmer, Ralf; Linette, Gerald; Chmielowski, Bartosz; Lao, Christopher D; Lorigan, Paul; Grossmann, Kenneth; Hassel, Jessica C; Sznol, Mario; Daud, Adil; Sosman, Jeffrey; Khushalani, Nikhil; Schadendorf, Dirk; Hoeller, Christoph; Walker, Dana; Kong, George; Horak, Christine; Weber, Jeffrey

2018-02-01

Purpose Until recently, limited options existed for patients with advanced melanoma who experienced disease progression while receiving treatment with ipilimumab. Here, we report the coprimary overall survival (OS) end point of CheckMate 037, which has previously shown that nivolumab resulted in more patients achieving an objective response compared with chemotherapy regimens in ipilimumab-refractory patients with advanced melanoma. Patients and Methods Patients were stratified by programmed death-ligand 1 expression, BRAF status, and best prior cytotoxic T-lymphocyte antigen-4 therapy response, then randomly assigned 2:1 to nivolumab 3 mg/kg intravenously every 2 weeks or investigator's choice chemotherapy (ICC; dacarbazine 1,000 mg/m 2 every 3 weeks or carboplatin area under the curve 6 plus paclitaxel 175 mg/m 2 every 3 weeks). Patients were treated until they experienced progression or unacceptable toxicity, with follow-up of approximately 2 years. Results Two hundred seventy-two patients were randomly assigned to nivolumab (99% treated) and 133 to ICC (77% treated). More nivolumab-treated patients had brain metastases (20% v 14%) and increased lactate dehydrogenase levels (52% v 38%) at baseline; 41% of patients treated with ICC versus 11% of patients treated with nivolumab received anti-programmed death 1 agents after randomly assigned therapy. Median OS was 16 months for nivolumab versus 14 months for ICC (hazard ratio, 0.95; 95.54% CI, 0.73 to 1.24); median progression-free survival was 3.1 months versus 3.7 months, respectively (hazard ratio, 1.0; 95.1% CI, 0.78 to 1.436). Overall response rate (27% v 10%) and median duration of response (32 months v 13 months) were notably higher for nivolumab versus ICC. Fewer grade 3 and 4 treatment-related adverse events were observed in patients on nivolumab (14% v 34%). Conclusion Nivolumab demonstrated higher, more durable responses but no difference in survival compared with ICC. OS should be interpreted with

Controlled breathing with or without peppermint aromatherapy for postoperative nausea and/or vomiting symptom relief: a randomized controlled trial.

Science.gov (United States)

Sites, Debra S; Johnson, Nancy T; Miller, Jacqueline A; Torbush, Pauline H; Hardin, Janis S; Knowles, Susan S; Nance, Jennifer; Fox, Tara H; Tart, Rebecca Creech

2014-02-01

With little scientific evidence to support use of aromatherapy for postoperative nausea and/or vomiting (PONV) symptoms, this study evaluated controlled breathing with peppermint aromatherapy (AR) and controlled breathing alone (CB) for PONV relief. A single blind randomized control trial design was used. On initial PONV complaint, symptomatic subjects received either CB (n = 16) or AR (n = 26) intervention based on randomization at enrollment. A second treatment was repeated at 5 minutes if indicated. Final assessment occurred 10 minutes post initial treatment. Rescue medication was offered for persistent symptoms. Among eligible subjects, PONV incidence was 21.4% (42/196). Gender was the only risk factor contributing to PONV symptoms (P = .0024). Though not statistically significant, CB was more efficacious than AR, 62.5% versus 57.7%, respectively. CB can be initiated without delay as an alternative to prescribed antiemetics. Data also support use of peppermint AR in conjunction with CB for PONV relief. Copyright © 2014 American Society of PeriAnesthesia Nurses. Published by Elsevier Inc. All rights reserved.

EFFECTIVENESS OF INSTUMENTAL ASSISTED SOFT TISSUE MOBILIZATION TECHNIQUE WITH STATIC STRETCHING IN SUBJECTS WITH PLANTAR FASCIITIS

Directory of Open Access Journals (Sweden)

Vinod Babu. K

2014-08-01

Full Text Available Background: Instrumental assisted soft tissue mobilization and static stretching found to be effective in plantar fasciitis, however the combined effectiveness of these techniques were unknown. The purpose of this study is to find the effect of Instrumental assisted soft tissue mobilization technique for plantar fascia combined with static stretching of triceps surae for subjects with chronic stage of Plantar Fasciitis on pain intensity, ankle dorsiflexion range of motion and functional disability. Methods: An experimental study design, selected subjects with chronic Plantar Fasciitis randomized subjects into each Study and Control group. Total of 40 subject’s data who completed study, 20 in each group, was used for analysis. Control group received conventional exercise while Study group received conventional exercises with Instrumental assisted soft tissue mobilization combined with static stretching of triceps surae muscle. Outcome measurements such as Intensity of pain using Numerical Pain Rating Scale-101 (NPRS-101, function disability using Foot Function Index Pain Subscale (FFI and ankle dorsiflexion active range of motion using Goniometer was measured before and after 2 weeks of intervention. Results: There is statistically significant improvement in means of NRS-101, ankle dorsiflexion active range of motion and Foot Function Index Pain Subscale after intervention in both groups. When the post-intervention means were compared between Study and Control group after 2 weeks of treatment there is statistically significant difference in means between the groups whereas study group showed greater percentage of improvement than control group. Conclusion: It is concluded that Instrumental assisted soft tissue mobilization technique combined with static stretching of triceps surae muscle is significantly effective than conventional exercises on reducing pain, improving ankle dorsiflexion range of motion and functional disability for subjects

Effect of thoracic mobilization on respiratory parameters in chronic non-specific low back pain: A randomized controlled trial.

Science.gov (United States)

Babina, R; Mohanty, P P; Pattnaik, M

2016-02-19

Altered respiratory function has been found to be associated with back pain. Limited chest excursion in subjects with chronic low back pain (CLBP) may be due to co-contraction or bracing of erector spinae and abdominal muscles; their flexed spinal posture; and/or their compromised spinal stability resulting from dysfunctional transversus abdominis. To check for the effects of thoracic mobilization on respiratory parameters in subjects with chronic non-specific low back pain. Sixty-two subjects (excluding 11 dropouts) with CLBP of age group 30-60 were randomly allocated to two groups. Both groups received individualized treatment for low back pain (LBP) and HEP (home exercise program) regime of breathing exercises. In addition, group 1 received Maitland's Central postero-anterior vertebral pressure for thoracic spine (T1-T8). Total treatment duration was 10 sessions in 2 weeks (5 sessions/week). Results showed significant improvement in respiratory parameters viz. Forced Vital Capacity (FVC), Sustained Maximal Inspiratory Pressure (SMIP) and Chest Wall Expansion (CWE) and Oswestry Disability Index (ODI) in both groups (pchronic low back pain with or without radiation to lower limbs when treated with thoracic central PA mobilization, in addition to LBP specific treatment and breathing exercises, show an improvement in respiratory parameters and reduction in disability.

How balance task-specific training contributes to improving physical function in older subjects undergoing rehabilitation following hip fracture: a randomized controlled trial.

Science.gov (United States)

Monticone, Marco; Ambrosini, Emilia; Brunati, Roberto; Capone, Antonio; Pagliari, Giulia; Secci, Claudio; Zatti, Giovanni; Ferrante, Simona

2018-03-01

To evaluate the efficacy of a rehabilitation programme including balance task-specific training in improving physical function, pain, activities of daily living (ADL), balance and quality of life in subjects after a hip fracture. Randomized controlled trial. A total of 52 older subjects selected for internal fixation due to extra-capsular hip fracture were randomized to be included in an experimental ( n = 26) and control group ( n = 26). The experimental group underwent a rehabilitation programme based on balance task-specific training. The control group underwent general physiotherapy, including open kinetic chain exercises and walking training. Both groups individually followed programmes of 90-minute sessions five times/week for three weeks. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a Pain Numerical Rating Scale, the Berg Balance Scale, the Functional Independence Measure and the 36-item Short-Form Health Survey. The participants were evaluated before and after training, and after 12 months. Significant effects of time, group and time × group were found for all outcome measures in favour of the experimental group. A clinically important between-group difference of 25 points was achieved after training and at follow-up in terms of the primary outcome (WOMAC function before treatment, after treatment and at follow-up was 84.8 (3.7), 39.8 (4.9) and 35.7 (6.2) for the experimental group and 80.9 (5.7), 65.2 (7.1) and 61.0 (11.1) for the control group). An inpatient rehabilitation programme based on balance task-specific training is useful in improving physical function, pain, ADL and quality of life in older patients after hip fracture.

Measles virus antibody responses in children randomly assigned to receive standard-titer edmonston-zagreb measles vaccine at 4.5 and 9 months of age, 9 months of age, or 9 and 18 months of age

DEFF Research Database (Denmark)

Martins, Cesario; Garly, May-Lill; Bale, Carlitos

2014-01-01

The World Health Organization recommends administration of measles vaccine (MV) at age 9 months in low-income countries. We tested the measles virus antibody response at 4.5, 9, 18, and 24 months of age for children randomly assigned to receive standard-titer Edmonston-Zagreb MV at 4.5 and 9 months...

Randomized trial of electrodynamic microneedle combined with 5% minoxidil topical solution for the treatment of Chinese male Androgenetic alopecia.

Science.gov (United States)

Bao, Linlin; Gong, Lin; Guo, Menger; Liu, Taoming; Shi, Anyu; Zong, Haifeng; Xu, Xuegang; Chen, Hongduo; Gao, Xinghua; Li, Yuanhong

2017-10-13

In treating androgenetic alopecia, 5% minoxidil is a commonly used topical drug. By using electrodynamic microneedle at the same time may increase absorption of minoxidil and further stimulate hair growth. A 24-week, randomized, evaluator blinded, comparative study was performed to evaluate the efficacy of treating Chinese male androgenetic alopecia using microneedle combined with 5% minoxidil topical solution. Randomized subjects received topical 5% minoxidil (group 1, n = 20), local electrodynamic microneedle treatments (group 2, n = 20), or local electrodynamic microneedle treatments plus topical 5% minoxidil (group 3, n = 20). A total of 12 microneedle treatments were performed every 2 weeks with 2ml 5% minoxidil delivery in group 3 during each microneedle treatment. Patient receiving topical 5% minoxidil applied 1 ml of the solution twice daily over the course of the study. A total of 60 Chinese male subjects with Norwood-Hamilton type III-VI androgenetic alopecia were treated. The mean improvement in total hair density from baseline to 24 weeks was 18.8/cm 2 in group 1, 23.4/cm 2 in group 2, and 38.3/cm 2 in group 3. The hair growth in the 3 groups was significantly different (P = 0.002), but there were no significant differences in toxicity found between the 3 groups. Treatment with microneedle plus topical 5% minoxidil was associated with the best hair growth.

Effectiveness of a lifestyle exercise program for older people receiving a restorative home care service: a pragmatic randomized controlled trial

Directory of Open Access Journals (Sweden)

Burton E

2013-12-01

Full Text Available Elissa Burton,1,2 Gill Lewin,1,2 Lindy Clemson,3 Duncan Boldy41Faculty of Health Sciences, Curtin University, Perth, WA, Australia; 2Research Department, Silver Chain, Perth, WA, Australia; 3Health and Work Research Unit, The University of Sydney, Sydney, NSW, Australia; 4School of Nursing and Midwifery, Curtin University, Perth, WA, AustraliaBackground: Restorative home care services are short-term and aimed at maximizing a person’s ability to live independently. They are multidimensional and often include an exercise program to improve strength, mobility, and balance. The aim of this study was to determine whether a lifestyle exercise program would be undertaken more often and result in greater functional gains than the current structured exercise program delivered as part of a restorative home care service for older adults.Methods: A pragmatic randomized controlled trial was conducted in an organization with an established restorative home care service. Individuals who were to have an exercise program as part of their service were randomized to receive either a lifestyle and functional exercise program called LiFE (as this was a new program, the intervention or the structured exercise program currently being used in the service (control. Exercise data collected by the individuals throughout and pre and post intervention testing was used to measure balance, strength, mobility, falls efficacy, vitality, function, and disability.Results: There was no difference between the groups in the amounts of exercise undertaken during the 8-week intervention period. Outcome measurement indicated that the LiFE program was as effective, and on 40% of the measures, more effective, than the structured exercise program.Conclusion: Organizations delivering restorative home care services that include an exercise component should consider whether LiFE rather than the exercise program they are currently using could help their clients achieve better outcomes

Effects of oral vitamin E on treatment of atopic dermatitis: A randomized controlled trial.

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Jaffary, Fariba; Faghihi, Gita; Mokhtarian, Arghavan; Hosseini, Sayed Mohsen

2015-11-01

The pathogenesis of atopic dermatitis (AD) remains to be determined; recently a possible change in the immune system with production of immunoglobulins is proposed. As vitamin E is a potent antioxidant, with the ability to decrease the serum levels of immunoglobulin E (IgE) in atopic patients, we aimed to evaluate the effect of oral vitamin E on treatment of AD. This randomized, double-blind, placebo-controlled trial comprised seventy participants with mild-to-moderate AD, based on the Hanifin and Rajka diagnostic criteria. The patients were randomly selected from teaching skin clinics in Isfahan, Iran. They were randomly assigned to two groups of equal number, receiving vitamin E (400 IU/day) and placebo for four 4 months. Each month, the extent, severity, and subjective symptoms including itch and sleeplessness were measured by SCORAD index. Three months after the end of intervention, the recurrence rate was assessed. The improvement in all symptoms, except sleeplessness, was significantly higher in the group receiving vitamin E than in controls (-1.5 vs. 0.218 in itching, -10.85 vs. -3.54 in extent of lesion, and -11.12 vs. -3.89 in SCORAD index, respectively, P vitamin E compared to the placebo group was 1.17, without significant differences between the two groups (P > 0.05). This study suggests that vitamin E can improve the symptoms and the quality of life in patients with AD. As vitamin E has no side effects with a dosage of 400 IU/day, it can be recommended for the treatment of AD.

Customized Versus Noncustomized Sound Therapy for Treatment of Tinnitus: A Randomized Crossover Clinical Trial.

Science.gov (United States)

Mahboubi, Hossein; Haidar, Yarah M; Kiumehr, Saman; Ziai, Kasra; Djalilian, Hamid R

2017-10-01

To determine the effectiveness of a customized sound therapy and compare its effectiveness to that of masking with broadband noise. Subjects were randomized to receive either customized sound therapy or broadband noise for 2 hours per day for 3 months and then switched to the other treatment after a washout period. The outcome variables were tinnitus loudness (scored 0-10), Tinnitus Handicap Inventory (THI), Beck Anxiety Inventory (BAI), minimum masking levels (MML), and residual inhibition (RI). Eighteen subjects completed the study. Mean age was 53 ± 11 years, and mean tinnitus duration was 118 ± 99 months. With customized sound therapy, mean loudness decreased from 6.4 ± 2.0 to 4.9 ± 1.9 ( P = .001), mean THI decreased from 42.8 ± 21.6 to 31.5 ± 20.3 ( P tinnitus patients, and the results may be superior to broadband noise.

A Panel Data Model for Subjective Information on Household Income Growth

NARCIS (Netherlands)

Das, J.W.M.; van Soest, A.H.O.

1996-01-01

Subjective expectations about future income changes are analyzed, using household panel data.The models used are extensions of existing binary choice panel data models to the case of ordered response.We consider both random and fixed individual effects.The random effects model is estimated by

rTMS of the prefrontal cortex has analgesic effects on neuropathic pain in subjects with spinal cord injury.

Science.gov (United States)

Nardone, R; Höller, Y; Langthaler, P B; Lochner, P; Golaszewski, S; Schwenker, K; Brigo, F; Trinka, E

2017-01-01

Repetitive transcranial magnetic stimulation study. The analgesic effects of repetitive transcranial magnetic stimulation (rTMS) in chronic pain have been the focus of several studies. In particular, rTMS of the premotor cortex/dorsolateral prefrontal cortex (PMC/DLPFC) changes pain perception in healthy subjects and has analgesic effects in acute postoperative pain, as well as in fibromyalgia patients. However, its effect on neuropathic pain in patients with traumatic spinal cord injury (SCI) has not been assessed. Merano (Italy) and Salzburg (Austria). In this study, we performed PMC/DLPFC rTMS in subjects with SCI and neuropathic pain. Twelve subjects with chronic cervical or thoracic SCI were randomized to receive 1250 pulses at 10 Hz rTMS (n=6) or sham rTMS (n=6) treatment for 10 sessions over 2 weeks. The visual analog scale, the sensory and affective pain rating indices of the McGill Pain Questionnaire (MPQ), the Hamilton Depression Rating Scale and the Hamilton Anxiety Rating Scale were used to assed pain and mood at baseline (T0), 1 day after the first week of treatment (T1), 1 day (T2), 1 week (T3) and 1 month (T4) after the last intervention. Subjects who received active rTMS had a statistically significant reduction in pain symptoms in comparison with their baseline pain, whereas sham rTMS participants had a non-significant change in daily pain from their baseline pain. The findings of this preliminary study in a small patient sample suggest that rTMS of the PMC/DLPFC may be effective in relieving neuropathic pain in SCI patients.

The effect of geriatric intervention in frail elderly patients receiving chemotherapy for colorectal cancer

DEFF Research Database (Denmark)

Lund, C M; Vistisen, K K; Dehlendorff, C

2017-01-01

patients are offered inclusion and are then randomized to two groups (the intervention group and the control group). Patients in the intervention group receive a full geriatric assessment of comorbidity, medication, psycho-cognitive function, physical, functional and nutrition status, and interventions......BACKGROUND: Better surgical techniques, chemotherapy and biological therapy have improved survival in patients with colorectal cancer (CRC), most markedly in younger patients. About half of patients over 70 years receive dose reductions or early treatment discontinuation of the planned adjuvant...... or first-line treatment due to side effects. The Comprehensive Geriatric Assessment (CGA) is a multidisciplinary evaluation of an elderly individual's health status. This assessment in older patients with cancer can predict survival, chemotherapy toxicity and morbidity. METHODS: This randomized phase II...

No Randomization? No Problem: Experimental Control and Random Assignment in Single Case Research

Science.gov (United States)

Ledford, Jennifer R.

2018-01-01

Randomization of large number of participants to different treatment groups is often not a feasible or preferable way to answer questions of immediate interest to professional practice. Single case designs (SCDs) are a class of research designs that are experimental in nature but require only a few participants, all of whom receive the…

Effect of multi axis vibration and subject postures on sketching ...

African Journals Online (AJOL)

Sedentary activities such as reading, writing, sketching, etc. are affected due to the train vibrations. Therefore, the present study investigates the extent of perceived difficulty and distortion in a sketching task by seated subjects in two postures under low frequency, multi axial random vibrations. Thirty male voluntary subjects ...

Perceptual Computing Aiding People in Making Subjective Judgments

CERN Document Server

Mendel, Jerry

2010-01-01

Explains for the first time how "computing with words" can aid in making subjective judgments. Lotfi Zadeh, the father of fuzzy logic, coined the phrase "computing with words" (CWW) to describe a methodology in which the objects of computation are words and propositions drawn from a natural language. Perceptual Computing explains how to implement CWW to aid in the important area of making subjective judgments, using a methodology that leads to an interactive device—a "Perceptual Computer"—that propagates random and linguistic uncertainties into the subjective judg

Safety, tolerability, and immunogenicity of the novel antituberculous vaccine RUTI: randomized, placebo-controlled phase II clinical trial in patients with latent tuberculosis infection.

Science.gov (United States)

Nell, Andre S; D'lom, Eva; Bouic, Patrick; Sabaté, Montserrat; Bosser, Ramon; Picas, Jordi; Amat, Mercè; Churchyard, Gavin; Cardona, Pere-Joan

2014-01-01

To evaluate the safety, tolerability and immunogenicity of three different doses (5, 25 and 50 µg) of the novel antituberculous vaccine RUTI compared to placebo in subjects with latent tuberculosis infection. Double-blind, randomized, placebo-controlled Phase II Clinical Trial (95 patients randomized). Three different RUTI doses and placebo were tested, randomized both in HIV-positive (n = 47) and HIV-negative subjects (n = 48), after completion of one month isoniazid (INH) pre-vaccination. Each subject received two vaccine administrations, 28 Days apart. Five patients withdrew and 90 patients completed the study. Assessment of safety showed no deaths during study. Two subjects had serious adverse events one had a retinal detachment while taking INH and was not randomized and the other had a severe local injection site abscess on each arm and was hospitalized; causality was assessed as very likely and by the end of the study the outcome had resolved. All the patients except 5 (21%) patients of the placebo group (3 HIV+ and 2 HIV-) reported at least one adverse event (AE) during the study. The most frequently occurring AEs among RUTI recipients were (% in HIV+/-): injection site reactions [erythema (91/92), induration (94/92), local nodules (46/25), local pain (66/75), sterile abscess (6/6), swelling (74/83), ulcer (20/11), headache (17/22) and nasopharyngitis (20/5)]. These events were mostly mild and well tolerated. Overall, a polyantigenic response was observed, which differed by HIV- status. The best polyantigenic response was obtained when administrating 25 µg RUTI, especially in HIV-positive subjects which was not increased after the second inoculation. This Phase II clinical trial demonstrates reasonable tolerability of RUTI. The immunogenicity profile of RUTI vaccine in LTBI subjects, even being variable among groups, allows us considering one single injection of one of the highest doses in future trials, preceded by an extended safety clinical

Weight loss maintenance in overweight subjects on ad libitum diets with high or low protein content and glycemic index

DEFF Research Database (Denmark)

Aller, E E J G; Larsen, Thomas Meinert; Holst, Claus

2014-01-01

Background:A high dietary protein (P) content and low glycemic index (GI) have been suggested to be beneficial for weight management, but long-term studies are scarce.Objective:The DIOGENES randomized clinical trial investigated the effect of P and GI on weight loss maintenance in overweight...... or obese adults in 8 centers across Europe. This study reports the 1-year results in 2 of the centers that extended the intervention to 1 year.Method:After an 8-week low calorie diet (LCD), 256 adults (BMI>27 kg/m(2)) were randomized to 5 ad libitum diets for 12 months: high P/low GI (HP/LGI), high P/high...... GI (HP/HGI), low P/low GI (LP/LGI), low P/high GI (LP/HGI) and a control diet. During the first 6 months foods were provided for free through a shop system, during the whole 12-month period subjects received guidance by a dietician. Primary outcome variable was the change in body weight over the 12...

The effect of neurofeedback on a brain wave and visual perception in stroke: a randomized control trial.

Science.gov (United States)

Cho, Hwi-Young; Kim, Kitae; Lee, Byounghee; Jung, Jinhwa

2015-03-01

[Purpose] This study investigated a brain wave and visual perception changes in stroke subjects using neurofeedback (NFB) training. [Subjects] Twenty-seven stroke subjects were randomly allocated to the NFB (n = 13) group and the control group (n=14). [Methods] Two expert therapists provided the NFB and CON groups with traditional rehabilitation therapy in 30 thirst-minute sessions over the course of 6 weeks. NFB training was provided only to the NFB group. The CON group received traditional rehabilitation therapy only. Before and after the 6-week intervention, a brain wave test and motor free visual perception test (MVPT) were performed. [Results] Both groups showed significant differences in their relative beta wave values and attention concentration quotients. Moreover, the NFB group showed a significant difference in MVPT visual discrimination, form constancy, visual memory, visual closure, spatial relation, raw score, and processing time. [Conclusion] This study demonstrated that NFB training is more effective for increasing concentration and visual perception changes than traditional rehabilitation. In further studies, detailed and diverse investigations should be performed considering the number and characteristics of subjects, and the NFB training period.

Performance Analysis of Receive Diversity in Wireless Sensor Networks over GBSBE Models

Science.gov (United States)

Goel, Shivali; Abawajy, Jemal H.; Kim, Tai-hoon

2010-01-01

Wireless sensor networks have attracted a lot of attention recently. In this paper, we develop a channel model based on the elliptical model for multipath components involving randomly placed scatterers in the scattering region with sensors deployed on a field. We verify that in a sensor network, the use of receive diversity techniques improves the performance of the system. Extensive performance analysis of the system is carried out for both single and multiple antennas with the applied receive diversity techniques. Performance analyses based on variations in receiver height, maximum multipath delay and transmit power have been performed considering different numbers of antenna elements present in the receiver array, Our results show that increasing the number of antenna elements for a wireless sensor network does indeed improve the BER rates that can be obtained. PMID:22163510

Intravenous dextrose for children with gastroenteritis and dehydration: a double-blind randomized controlled trial.

Science.gov (United States)

Levy, Jason A; Bachur, Richard G; Monuteaux, Michael C; Waltzman, Mark

2013-03-01

We seek to determine whether an initial intravenous bolus of 5% dextrose in normal saline solution compared with normal saline solution will lead to a lower proportion of hospitalized patients and a greater reduction in serum ketone levels in children with gastroenteritis and dehydration. We enrolled children aged 6 months to 6 years in a double-blind, randomized controlled trial of patients presenting to a pediatric emergency department. Subjects were randomized to receive a 20 mL/kg infusion of either 5% dextrose in normal saline solution or normal saline solution. Serum ketone levels were measured before and at 1- and 2-hour intervals after the initial study fluid bolus administration. Primary outcome was the proportion of children hospitalized. Secondary outcome was change in serum ketone levels over time. One hundred eighty-eight children were enrolled. The proportion of children hospitalized did not differ between groups (35% in the 5% dextrose in normal saline solution group versus 44% in the normal saline solution group; risk difference 9%; 95% confidence interval [CI] -5% to 22%). Compared with children who received normal saline solution, those who received 5% dextrose in normal saline solution had a greater reduction in mean serum ketone levels at both 1 hour (mean Δ 1.2 versus 0.1 mmol/L; mean difference 1.1 mmol/L; 95% CI 0.4 to 1.9 mmol/L) and 2 hours (mean Δ 1.9 versus 0.3 mmol/L; mean difference 1.6 mmol/L; 95% CI 0.9 to 2.3 mmol/L). Administration of a dextrose-containing bolus compared with normal saline did not lead to a lower rate of hospitalization for children with gastroenteritis and dehydration. There was, however, a greater reduction in serum ketone levels in patients who received 5% dextrose in normal saline solution. Copyright © 2012. Published by Mosby, Inc.

Tezosentan reduces the microvascular filtration coefficient in isolated lungs from rats subjected to cecum ligation and puncture.

Science.gov (United States)

Kuklin, Vladimir; Sovershaev, Mikhail; Andreasen, Thomas; Skogen, Vegard; Ytrehus, Kirsti; Bjertnaes, Lars

2005-01-01

We recently demonstrated that the non-selective endothelin-1 (ET-1) receptor blocker tezosentan antagonizes ovine acute lung injury (ALI) following infusion of endotoxin or ET-1 by reducing the enhanced lung microvascular pressure, although we could not exclude the possibility of a simultaneous decline in microvascular permeability. In the present study, our aim was to find out if tezosentan reverses the rise in microvascular filtration coefficient (Kfc) in rat lungs that have been isolated and perfused 12 h after cecum ligation and puncture (CLP) or infusion of ET-1. Wistar rats (n = 42) were subjected to CLP. Postoperatively, rats were randomized to a CLP group (n = 7) and a CLP + tezosentan group (n = 7); the latter received tezosentan 30 mg/kg. A sham-operated group (n = 5) underwent laparotomy without CLP. Twelve hours postoperatively, the lungs were isolated and perfused with blood from similarly treated rats that also were used to assess plasma concentration of ET-1 and protein kinase Calpha (PKCalpha) in lung tissue. Additionally, isolated blood perfused lungs from healthy rats were randomized to a control group (n = 8), an ET-1 group (n = 7) subjected to pulmonary arterial injection of ET-1 10 nM, and an ET-1 + tezosentan group (n = 7) that received tezosentan 30 mg/kg. All lung preparations received papaverine 0.1 microg/kg added to the perfusate for vasoplegia. Pulmonary hemodynamic variables, Kfc and lung compliance (CL) were assessed. After CLP, the plasma concentration of ET-1 increased. Papaverine abolished the vasoconstrictor response to ET-1 and the pulmonary vascular pressures remained close to baseline throughout the experiments. Both CLP and injection of ET-1 caused significant changes in Kfc and CL that were prevented in tezosentan-treated rats. Compared to sham-operated animals, CLP increased the content of PKCalpha by 50% and 70% in the cytosolic and the membrane fractions of lung tissue homogenates, respectively. Tezosentan prevented the

Family Support and Subjective Well-Being

DEFF Research Database (Denmark)

Schnettler, Berta; Denegri, Marianela; Miranda, Horacio

2015-01-01

In order to distinguish typologies of university students based on family support received in the form of tangible and intangible resources, their level of satisfaction with life and food-related life as well as subjective happiness, a survey was applied to a non-probabilistic sample of 347...... in the place of residence during the period of studies, socioeconomic level, need to work while studying, frequency and time available for having lunch in the place of residence, and body mass index. The family support students receive as tangible or economic resources is positively related to life...

Ketamine as an Adjunct to Opioids for Acute Pain in the Emergency Department: A Randomized Controlled Trial.

Science.gov (United States)

Bowers, Karen J; McAllister, Kelly B; Ray, Meredith; Heitz, Corey

2017-06-01

This study had five objectives: 1) to measure and compare total opioid use and number of opioid doses in patients treated with opioids versus ketamine in conjunction with opioids; 2) to measure pain scores up to 2 hours after presentation in the ED patient with pain, comparing standard opioid pain control to ketamine in conjunction with opioids; 3) to compare patient satisfaction with pain control using opioids alone versus ketamine in conjunction with opioids; 4) to monitor and compare side effects in patients treated with opioids versus ketamine in conjunction with opioids; and 5) to identify effect variation between different subgroups of patients, with the purpose of focusing future research. We hypothesized that low-dose ketamine, compared to placebo, as an adjunctive treatment to opioids would result in better pain control over 2 hours and greater patient satisfaction with pain control; further, this protocol will result in a lower opioid dosage over 2 hours. This was a randomized, double-blinded, placebo-controlled trial at a single academic emergency department evaluating the use of ketamine versus placebo in conjunction with opioids for moderate to severe pain. Subjects with a continued high level of pain after an initial dose of opioid analgesia were randomized to receive either 0.1 mg/kg ketamine or placebo prior to protocol-based dosing of additional opioid analgesia, if required. Over 120 minutes, subjects were assessed for pain level (0-10), satisfaction with pain control (0-4), side effects, sedation level, and need for additional pain medication. Total opioid dose, including the initial dose, was compared between groups. Sixty-three subjects were randomized to the placebo group and 53 to the ketamine group. No significant differences were found in demographics between the groups. Patients receiving ketamine reported lower pain scores over 120 minutes than patients receiving placebo (p = 0.015). Total opioid dose was lower in the ketamine group

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

Science.gov (United States)

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

Exenatide has a Pronounced Effect on Energy Intake but not Energy Expenditure in Non-Diabetic Subjects with Obesity: A Randomized, Double-blind, Placebo-Controlled Trial.

Science.gov (United States)

Basolo, Alessio; Burkholder, Joshua; Osgood, Kristy; Graham, Alexis; Bundrick, Sarah; Frankl, Joseph; Piaggi, Paolo; Thearle, Marie S; Krakoff, Jonathan

2018-03-26

Exenatide is a glucagon-like peptide 1 (GLP-1) mimetic which induces weight loss predominantly, it is presumed, via decreased food intake. However, circulating GLP-1 is also a determinant of energy expenditure. We sought to quantify the effect of exenatide on energy expenditure (EE) and energy intake. In this single-center, randomized double-blind placebo controlled trial, we randomized 80 healthy, non-diabetic volunteers with obesity (46 women, age: 34.4±8.7 y, body fat by DXA: 44.2±7.8%) to subcutaneous exenatide 10 μg twice daily or placebo. Subjects were admitted to our clinical research unit for measurement of 24h-EE in a whole-room indirect calorimeter and ad libitum food intake using an automated vending machine paradigm before and after randomization. Furthermore, energy expenditure and ad libitum food intake measures were repeated at 24-week after readmission for 7-day inpatient stay. Body weight was obtained weekly for up to 5 weeks and was recorded at each monthly follow up visit up to 24 weeks. Prior to randomization, participants over ate during the 3-day vending machine period in the whole study group (114.6±35.2 %), expressed as percentage of weight maintaining energy needs (WMEN) with those who were eventually randomized to exenatide overeating more (121.6±37.7 %) compared to placebo group (107.6±31.5 %). In the exenatide group, ad libitum absolute energy intake decreased by 1016.1±724.5 kcal/day (95% CI: -1250.9 to -781.2) versus a 245.1±710.5 kcal/day (95% CI: -475.4 to -14.7) decrease in placebo (Δ= -624.8 Kcal/day, p energy intake between exenatide group and placebo group and the treatment group decreased 24-h EE more compared to placebo (β = -160.6 Kcal/day, 95% CI: -307.6 to 13.6, p = 0.03) compared to their pre-randomization measurement. However, this reduction was not present after adjustment for changes in FM and FFM (β = -87 kcal/day, p = 0.14). No difference was observed in body weight (Δ = -1.72 kg, 95% CI: -5.77 to 2.30, p

The Effect of Foot Exercises on Wound Healing in Type 2 Diabetic Patients With a Foot Ulcer: A Randomized Control Study.

Science.gov (United States)

Eraydin, Şahizer; Avşar, Gülçin

The purpose of this study was to investigate the effect of foot exercises on wound healing in type 2 diabetic patients with a diabetic foot ulcer. Prospective, randomized controlled study. Sixty-five patients from an outpatient clinic with grade 1 or 2 ulcers (Wagner classification) who met study criteria agreed to participate; 60 patients completed the study and were included in the final analysis. Subjects were followed up between February 2014 and June 2015. Subjects were recruited by the researchers in the clinics where they received treatment. Subjects were randomly allocated to either the control or intervention group. Data were collected using investigator-developed forms: patient information form and the diabetic foot exercises log. Patients in the intervention group received standard wound care and performed daily foot exercises for 12 weeks; the control group received standard wound care but no exercises. The ulcers of the patients in both the intervention and control groups were examined and measured at the 4th, 8th, and 12th weeks. The groups were compared in terms of the ulcer size and depth. To analyze and compare the data, frequency distribution, mean (standard deviation), variance analysis, and the independent samples t test and the χ test were used. The mean ulcer areas were 12.63 (14.43), 6.91 (5.44), 4.30 (3.70), and 3.29 (3.80) cm (P diabetic foot ulcer sizes in the study intervention group in the 4th and 12th weeks compared to beginning baseline (P ≤ .05). However, only the 12th week was different from the beginning in the control group (P = .000). The mean depths of the ulcers were 0.56 (0.85), 0.42 (0.68), 0.36 (0.50), and 0.28 (0.38) cm in the study intervention group (P foot exercises should be included in the treatment plan when managing patients with diabetic foot ulcers.

Energy and nitrogen balances in 24 severely burned patients receiving 4 isocaloric diets of about 10 MJ/m2/day (2392 Kcalories/m2/day).

Science.gov (United States)

Serog, P; Baigts, F; Apfelbaum, M; Guilbaud, J; Chauvin, B; Pecqueur, M L

1983-07-01

Twenty-four subjects with burns ranging from 25-70 per cent received for 12 days exclusively per os a series of 4 isocaloric diets of about 4000 Kcal--'normal', or hyperproteic, or hyperlipidic, or hyperglucidic according to a randomized schedule. Oxygen consumptions were measured at the end of each diet and nitrogen balance was determined every day. Though patients were not massively overfed there remained a positive energy gap. The nitrogen balance was found to be equilibrated on the whole but clearly positive with the hyperproteic diet and clearly negative with the hyperlipidic-normoproteic diet. Thus there is no rationale for the huge energy overfeeding classically used.

Effects of Horticulture on Frail and Prefrail Nursing Home Residents: A Randomized Controlled Trial.

Science.gov (United States)

Lai, Claudia K Y; Kwan, Rick Y C; Lo, Shirley K L; Fung, Connie Y Y; Lau, Jordan K H; Tse, Mimi M Y

2018-05-24

Frail nursing home residents face multiple health challenges as a result of their frail status. The aim of this study was to examine the effects of HT on the psychosocial well-being of frail and prefrail nursing home residents. Randomized controlled trial. Nursing homes. One hundred eleven participants were randomly allocated into the intervention [horticultural therapy (HT)] and control (social activities) conditions. HT group participants attended a weekly 60-minute session for 8 consecutive weeks. Control group activities were social in nature, without any horticulture components. The outcome measures include happiness, depressive symptoms, self-efficacy, well-being, social network, and social engagement. The time points of measurement were at baseline (T 0 ), immediately postintervention (T 1 ), and 12 weeks postintervention (T 2 ). A modified intention-to-treat approach was adopted. A multivariate general estimating equation was used to analyze the data. Forty-six and 50 participants received at least 1 session of the intervention and control condition protocol, respectively. A significant interaction effect between group and time was observed only on the happiness scale (β = 1.457, P = .036), but not on other outcome variables. In a follow-up cluster analysis of those who received HT, a greater effect on subjective happiness (mean difference = 6.23, P < .001) was observed for participants who were happier at baseline. HT was found to be effective in promoting subjective happiness for frail and prefrail nursing home residents. Its favorable effect suggests that HT should be used to promote the psychosocial well-being of those who are frail. Copyright © 2018 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

Efficacy of amoxicillin with and without decongestant-antihistamine for otitis media with effusion in children. Results of a double-blind, randomized trial.

Science.gov (United States)

Mandel, E M; Rockette, H E; Bluestone, C D; Paradise, J L; Nozza, R J

1987-02-19

In a randomized, double-blind, placebo-controlled trial involving 518 infants and children who had otitis media with effusion ("secretory" otitis media), we evaluated the efficacy of a two-week course of amoxicillin (40 mg per kilogram of body weight per day) with and without a four-week course of an oral decongestant-antihistamine combination. Among the 474 subjects who were evaluated at the four-week end point, the rate of resolution of middle-ear effusion was twice as high in those treated with amoxicillin, either with or without the decongestant-antihistamine, as in those who received placebo (P less than 0.001), but 69.8 percent of the amoxicillin-treated subjects still had effusion. Among both the amoxicillin-treated subjects and the placebo-treated subjects, resolution was more likely in those with initially unilateral effusion, in those who had had effusion for eight weeks or less, and in those without an upper respiratory tract infection at the four-week end point. Side effects were reported more often in subjects who received decongestant-antihistamine than in those who did not. Among the subjects without effusion at the four-week end point, recurrent effusion developed in approximately half those in both the amoxicillin and placebo groups during the subsequent three months. We conclude that in infants and children with otitis media with effusion, amoxicillin treatment increases to some extent the likelihood of resolution.

Wii Fit® training vs. Adapted Physical Activities: which one is the most appropriate to improve the balance of independent senior subjects? A randomized controlled study.

Science.gov (United States)

Toulotte, Claire; Toursel, Cindy; Olivier, Nicolas

2012-09-01

To compare the effectiveness of three protocols (Adapted Physical Activities, Wii Fit(®), Adapted Physical Activities + Wii Fit(®)) on the balance of independent senior subjects. Case comparison study. Healthy elderly subjects living in independent community dwellings. Thirty-six subjects, average age 75.09 ± 10.26 years, took part in this study, and were randomly assigned to one of the four experimental groups: G1 followed an Adapted Physical Activities training programme, while the second group (G2) participated in Wii Fit(®) training and the third one (G3) combined both methods. There was no training for the fourth group (G4). All subjects trained once a week (1 hour) for 20 weeks and were assessed before and after treatment. The Tinetti test, unipedal tests and the Wii Fit(®) tests. After training, the scores in the Tinetti test decreased significantly (P Wii Fit(®)) and G3 (Adapted Physical Activities and Wii Fit(®)) improved their balance. In addition, G1 and G3 increased their dynamic balance. The findings suggest that Adapted Physical Activities training limits the decline in sensorial functions in the elderly.

Improved Adherence to Vision Self-monitoring with the Vision and Memory Stimulating (VMS) Journal for Non-neovascular Age-related Macular Degeneration during a Randomized Controlled Trial

OpenAIRE

Bittner, Ava K; Torr-Brown, Sheryl; Arnold, Ellen; Nwankwo, Antonia; Beaton, Patricia; Rampat, Radhika; Dagnelie, Gislin; Roser, Mark

2014-01-01

Objective An educational, interactive journal [Vision and Memory Stimulating (VMS) journal] was developed to boost patient confidence and promote long-term adherence with weekly vision self-monitoring in age-related macular degeneration (AMD) patients at risk for vision loss from new-onset neovascularization. Methods In a multicenter randomized controlled trial, 198 subjects with intermediate stage, non-neovascular AMD received the VMS journal or followed usual care (e.g. their doctor’s instr...

Impact of intermittent hypoxia and exercise on blood pressure and metabolic features from obese subjects suffering sleep apnea-hypopnea syndrome.

Science.gov (United States)

González-Muniesa, P; Lopez-Pascual, A; de Andrés, J; Lasa, A; Portillo, M P; Arós, F; Durán, J; Egea, C J; Martinez, J A

2015-09-01

Strategies designed to reduce adiposity and cardiovascular-accompanying manifestations have been based on nutritional interventions conjointly with physical activity programs. The aim of this 13-week study was to investigate the putative benefits associated to hypoxia plus exercise on weight loss and relevant metabolic and cardiorespiratory variables, when prescribed to obese subjects with sleep apnea syndrome following dietary advice. The participants were randomly distributed in the following three groups: control, normoxia, and hypoxia. All the subjects received dietary advice while, additionally, normoxia group was trained under normal oxygen concentration and Hypoxia group under hypoxic conditions. There was a statistically significant decrease in fat-free mass (Kg) and water (%) on the control compared to normoxia group (p hypoxia compared to control group (p hypoxia group showed some specific benefits concerning appetite and cardiometabolic-related measurements as exertion time and diastolic blood pressure, with a therapeutical potential.

The efficacy of a brief motivational enhancement education program on CPAP adherence in OSA: a randomized controlled trial.

Science.gov (United States)

Lai, Agnes Y K; Fong, Daniel Y T; Lam, Jamie C M; Weaver, Terri E; Ip, Mary S M

2014-09-01

Poor adherence to CPAP treatment in OSA adversely affects the effectiveness of this therapy. This randomized controlled trial (RCT) examined the efficacy of a brief motivational enhancement education program in improving adherence to CPAP treatment in subjects with OSA. Subjects with newly diagnosed OSA were recruited into this RCT. The control group received usual advice on the importance of CPAP therapy and its care. The intervention group received usual care plus a brief motivational enhancement education program directed at enhancing the subjects' knowledge, motivation, and self-efficacy to use CPAP through the use of a 25-min video, a 20-min patient-centered interview, and a 10-min telephone follow-up. Self-reported daytime sleepiness adherence-related cognitions and quality of life were assessed at 1 month and 3 months. CPAP usage data were downloaded at the completion of this 3-month study. One hundred subjects with OSA (mean ± SD, age 52 ± 10 years; Epworth Sleepiness Scales [ESS], 9 ± 5; median [interquartile range] apnea-hypopnea index, 29 [20, 53] events/h) prescribed CPAP treatment were recruited. The intervention group had better CPAP use (higher daily CPAP usage by 2 h/d [Cohen d = 1.33, P motivational enhancement education in addition to usual care were more likely to show better adherence to CPAP treatment, with greater improvements in treatment self-efficacy and daytime sleepiness. ClinicalTrials.gov; No.: NCT01173406; URL: www.clinicaltrials.gov.

Renal effects of hyperinsulinaemia in subjects with two hypertensive parents

DEFF Research Database (Denmark)

Andersen, U B; Skøtt, P; Bruun, N E

1999-01-01

aged 18-35 years whose parents both had essential hypertension, and 22 age- and sex-matched subjects whose parents were both normotensive. Diabetes or morbid obesity in any subject or parent excluded the family. The 24-h blood pressure was measured. The subjects received an isocaloric diet with a fixed...... the sodium-retaining effect of insulin was more pronounced in subjects with a strong genetic predisposition to essential hypertension than in subjects with normotensive parents. This effect may contribute to the development of hypertension in subjects with a genetic predisposition to hypertension....

Effects of lifestyle intervention and meal replacement on glycaemic and body-weight control in Chinese subjects with impaired glucose regulation: a 1-year randomised controlled trial.

Science.gov (United States)

Xu, Dan-Feng; Sun, Jian-Qin; Chen, Min; Chen, Yan-Qiu; Xie, Hua; Sun, Wei-Jia; Lin, Yi-Fan; Jiang, Jing-Jing; Sun, Wei; Chen, Ai-Fang; Tang, Qian-Ru

2013-02-14

The purpose of the present study was to evaluate the impact of a lifestyle intervention programme, combined with a daily low-glycaemic index meal replacement, on body-weight and glycaemic control in subjects with impaired glucose regulation (IGR). Subjects with IGR were randomly assigned to an intervention group (n 46) and a control group (n 42). Both groups received health counselling at baseline. The intervention group also received a daily meal replacement and intensive lifestyle intervention to promote healthy eating habits during the first 3 months of the study, and follow-up visits performed monthly until the end of the 1-year study. Outcome measurements included changes in plasma glucose, glycated Hb (HbA1c), plasma lipids, body weight, blood pressure and body composition (such as body fat mass and visceral fat area). The results showed that body-weight loss after 1 year was significant in the intervention group compared with the control group (-1·8 (SEM 0·35) v. -0·6 (SEM 0·40) 2·5 kg, Pmeal replacement is beneficial in promoting IGR to NGR.

The Effect of Choosing versus Receiving Feedback on College Students' Performance

Science.gov (United States)

Cutumisu, Maria; Schwartz, Daniel L.

2016-01-01

This study examines the effect of choosing versus receiving feedback on the learning performance of n = 98 post-secondary students from California on a digital poster design task. The study employs a yoked experimental design where college students are randomly assigned to play a choice-based assessment game, Posterlet, in one of two conditions,…

Continuous Femoral Nerve Block versus Intravenous Patient Controlled Analgesia for Knee Mobility and Long-Term Pain in Patients Receiving Total Knee Replacement: A Randomized Controlled Trial

Directory of Open Access Journals (Sweden)

Lihua Peng

2014-01-01

Full Text Available Objectives. To evaluate the comparative analgesia effectiveness and safety of postoperative continuous femoral nerve block (CFNB with patient controlled intravenous analgesia (PCIA and their impact on knee function and chronic postoperative pain. Methods. Participants were randomly allocated to receive postoperative continuous femoral nerve block (group CFNB or intravenous patient controlled analgesia (group PCIA. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC scores for knee and incidence of chronic postoperative pain at 3, 6, and 12 months postoperatively were compared. postoperative pain and salvage medication at rest or during mobilization 24 hours, 48 hours, and 7 days postoperatively were also recorded. Results. After discharge from the hospital and rehabilitation of joint function, patients in group CFNB reported significantly improved knee flexion and less incidence of chronic postoperative pain at 3 months and 6 months postoperatively (P<0.05. Analgesic rescue medications were significantly reduced in patients receiving CFNB (P<0.001 and P=0.031, resp.. Conclusion. With standardized rehabilitation therapy, continuous femoral nerve block analgesia reduced the incidence of chronic postoperative pain, improved motility of replaced joints, and reduced the dosages of rescue analgesic medications, suggesting a recovery-enhancing effect of peripheral nerve block analgesia.

Reduction of seizure occurrence from exposure to auditory stimulation in individuals with neurological handicaps: a randomized controlled trial.

Directory of Open Access Journals (Sweden)

Mark Bodner

Full Text Available The purpose of this work was to determine in a clinical trial the efficacy of reducing or preventing seizures in patients with neurological handicaps through sustained cortical activation evoked by passive exposure to a specific auditory stimulus (particular music. The specific type of stimulation had been determined in previous studies to evoke anti-epileptiform/anti-seizure brain activity.The study was conducted at the Thad E. Saleeby Center in Harstville, South Carolina, which is a permanent residence for individuals with heterogeneous neurological impairments, many with epilepsy. We investigated the ability to reduce or prevent seizures in subjects through cortical stimulation from sustained passive nightly exposure to a specific auditory stimulus (music in a three-year randomized controlled study. In year 1, baseline seizure rates were established. In year 2, subjects were randomly assigned to treatment and control groups. Treatment group subjects were exposed during sleeping hours to specific music at regular intervals. Control subjects received no music exposure and were maintained on regular anti-seizure medication. In year 3, music treatment was terminated and seizure rates followed. We found a significant treatment effect (p = 0.024 during the treatment phase persisting through the follow-up phase (p = 0.002. Subjects exposed to treatment exhibited a significant 24% decrease in seizures during the treatment phase, and a 33% decrease persisting through the follow-up phase. Twenty-four percent of treatment subjects exhibited a complete absence of seizures during treatment.Exposure to specific auditory stimuli (i.e. music can significantly reduce seizures in subjects with a range of epilepsy and seizure types, in some cases achieving a complete cessation of seizures. These results are consistent with previous work showing reductions in epileptiform activity from particular music exposure and offers potential for achieving a non

Books Received

Indian Academy of Sciences (India)

Home; Journals; Resonance – Journal of Science Education. Books Received. Articles in Resonance – Journal of Science Education. Volume 1 Issue 1 January 1996 pp 118-118 Books Received. Books Received · More Details Fulltext PDF. Volume 1 Issue 2 February 1996 pp 120-120 Books Received. Books Received.

Long-pulsed dye laser versus intense pulsed light for photodamaged skin: A randomized split-face trial with blinded response evaluation

DEFF Research Database (Denmark)

Jorgensen, G.F.; Hedelund, L.; Haedersdal, M.

2008-01-01

Objective: In a randomized controlled split-face trial to evaluate efficacy and adverse effects from rejuvenation with long-pulsed dye laser (LPDL) versus intense pulsed light (IPL). Materials and Methods: Twenty female volunteers with Fitzpatrick skin types I-III, classes I-II rhytids......, and symmetrical split-face photodamage were included in the study. Subjects received a series of three treatments at 3-week intervals with half-face LPDL (V-beam Perfecta, 595 nm, Candela Laser Corporation) and half-face IPL (Ellipse Flex, Danish Dermatologic Development); the interventions being randomly...... assigned to left and right sides. Primary end-points were telangiectasias, irregular pigmentation and preferred treatment. Secondary end-points were skin texture, rhytids, pain, and adverse effects. Efficacy was evaluated by patient self-assessments and by blinded clinical on-site and photographic...

A randomized cross-over trial to detect differences in arm volume after low- and heavy-load resistance exercise among patients receiving adjuvant chemotherapy for breast cancer at risk for arm lymphedema

DEFF Research Database (Denmark)

Bloomquist, Kira; Hayes, Sandi; Adamsen, Lis

2016-01-01

changes after resistance exercise with heavy loads in this population. The purpose of this study is to determine acute changes in arm volume after a session of low- and heavy-load resistance exercise among women undergoing adjuvant chemotherapy for breast cancer at risk for arm lymphedema. METHODS....../DESIGN: This is a randomized cross-over trial. PARTICIPANTS: Women receiving adjuvant chemotherapy for breast cancer who have undergone axillary lymph node dissection will be recruited from rehabilitation centers in the Copenhagen area. INTERVENTION: Participants will be randomly assigned to engage in a low- (two sets of 15...... was calculated based on changes in L-Dex scores between baseline and 72-hours post exercise sessions. DISCUSSION: Findings from this study are relevant for exercise prescription guidelines, as well as recommendations regarding participating in activities of daily living for women following surgery for breast...

Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial

Science.gov (United States)

2013-01-01

Background Psychological stress occurs when an individual perceives that environmental demands tax or exceed his or her adaptive capacity. Its association with severe health and emotional diseases, points out the necessity to find new efficient strategies to treat it. Moreover, psychological stress is a very personal problem and requires training focused on the specific needs of individuals. To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new paradigm for e-health - Interreality - that integrates contextualized assessment and treatment within a hybrid environment, bridging the physical and the virtual worlds. According to this premise, the aim of this study is to investigate the advantages of using advanced technologies, in combination with cognitive behavioral therapy (CBT), based on a protocol for reducing psychological stress. Methods/Design The study is designed as a randomized controlled trial. It includes three groups of approximately 50 subjects each who suffer from psychological stress: (1) the experimental group, (2) the control group, (3) the waiting list group. Participants included in the experimental group will receive a treatment based on cognitive behavioral techniques combined with virtual reality, biofeedback and mobile phone, while the control group will receive traditional stress management CBT-based training, without the use of new technologies. The wait-list group will be reassessed and compared with the two other groups five weeks after the initial evaluation. After the reassessment, the wait-list patients will randomly receive one of the two other treatments. Psychometric and physiological outcomes will serve as quantitative dependent variables, while subjective reports of participants will be used as the qualitative dependent variable. Discussion What we would like to show with the present trial is that bridging virtual experiences, used to learn coping skills and emotional regulation, with real

Intermittent preventive treatment of malaria in pregnancy with mefloquine in HIV-infected women receiving cotrimoxazole prophylaxis: a multicenter randomized placebo-controlled trial.

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Raquel González

2014-09-01

Full Text Available BACKGROUND: Intermittent preventive treatment in pregnancy (IPTp with sulfadoxine-pyrimethamine (SP is recommended for malaria prevention in HIV-negative pregnant women, but it is contraindicated in HIV-infected women taking daily cotrimoxazole prophylaxis (CTXp because of potential added risk of adverse effects associated with taking two antifolate drugs simultaneously. We studied the safety and efficacy of mefloquine (MQ in women receiving CTXp and long-lasting insecticide treated nets (LLITNs. METHODS AND FINDINGS: A total of 1,071 HIV-infected women from Kenya, Mozambique, and Tanzania were randomized to receive either three doses of IPTp-MQ (15 mg/kg or placebo given at least one month apart; all received CTXp and a LLITN. IPTp-MQ was associated with reduced rates of maternal parasitemia (risk ratio [RR], 0.47 [95% CI 0.27-0.82]; p=0.008, placental malaria (RR, 0.52 [95% CI 0.29-0.90]; p=0.021, and reduced incidence of non-obstetric hospital admissions (RR, 0.59 [95% CI 0.37-0.95]; p=0.031 in the intention to treat (ITT analysis. There were no differences in the prevalence of adverse pregnancy outcomes between groups. Drug tolerability was poorer in the MQ group compared to the control group (29.6% referred dizziness and 23.9% vomiting after the first IPTp-MQ administration. HIV viral load at delivery was higher in the MQ group compared to the control group (p=0.048 in the ATP analysis. The frequency of perinatal mother to child transmission of HIV was increased in women who received MQ (RR, 1.95 [95% CI 1.14-3.33]; p=0.015. The main limitation of the latter finding relates to the exploratory nature of this part of the analysis. CONCLUSIONS: An effective antimalarial added to CTXp and LLITNs in HIV-infected pregnant women can improve malaria prevention, as well as maternal health through reduction in hospital admissions. However, MQ was not well tolerated, limiting its potential for IPTp and indicating the need to find alternatives with

Effect of Heated Humidification on CPAP Therapy Adherence in Subjects With Obstructive Sleep Apnea With Nasopharyngeal Symptoms.

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Soudorn, Chuleekorn; Muntham, Dittapol; Reutrakul, Sirimon; Chirakalwasan, Naricha

2016-09-01

The addition of heated humidification to CPAP has been shown to improve nasal adverse effects in subjects with obstructive sleep apnea (OSA). However, current data regarding improvement in CPAP adherence is conflicting. Furthermore, there are no data from a tropical climate area with a high humidity level. In this prospective randomized crossover study conducted in Thailand, subjects with moderate to severe OSA with nasopharyngeal symptoms post-split-night study were enrolled in the study. Subjects were randomly assigned to receive CPAP with or without heated humidification for 4 weeks and then crossed over. Information on CPAP adherence, quality of life assessed by the Functional Outcomes of Sleep Questionnaire, nasopharyngeal symptoms assessed by a modified XERO questionnaire, and bedroom ambient humidity and temperature data were obtained. Data were collected on 20 subjects with OSA during the period of January to December 2014. Although the addition of heated humidification appeared to improve average hours of use for all days when compared with conventional CPAP, the difference was not statistically significant (CPAP with heated humidification = 4.6 ± 1.7 h/night; conventional CPAP = 4.0 ± 1.7 h/night, P = .1). However, the addition of heated humidification improved CPAP adherence on the days of use (5.5 ± 1.5 h/night) compared with conventional CPAP (5.2 ± 1.4 h/night), P = .033. Quality of life was also improved according to the Functional Outcomes of Sleep Questionnaire score (median 17.6 [interquartile range 3.5]) in the heated humidification group compared with conventional CPAP group (median 17.6 [interquartile range 4.5]), P = .046. Significant reduction in the dry throat/sore throat symptom was noted only when CPAP with heated humidification was used. Even in a tropical climate area, CPAP adherence and quality of life appeared to improve when heated humidification was employed in subjects with moderate to severe OSA with nasopharyngeal symptoms

Performance Analysis of Receive Diversity in Wireless Sensor Networks over GBSBE Models

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Tai-hoon Kim

2010-12-01

Full Text Available Wireless sensor networks have attracted a lot of attention recently. In this paper, we develop a channel model based on the elliptical model for multipath components involving randomly placed scatterers in the scattering region with sensors deployed on a field. We verify that in a sensor network, the use of receive diversity techniques improves the performance of the system. Extensive performance analysis of the system is carried out for both single and multiple antennas with the applied receive diversity techniques. Performance analyses based on variations in receiver height, maximum multipath delay and transmit power have been performed considering different numbers of antenna elements present in the receiver array, Our results show that increasing the number of antenna elements for a wireless sensor network does indeed improve the BER rates that can be obtained.

Clinical Evaluation of Commiphora Mukul, a Botanical resin, in the Management of Hemorrhoids: A randomized controlled trial

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Yousefi, Mahdi; Mahdavi, Mohammad Reza Vaez; Hosseini, Seyed Mousalreza; Bahrami, Abdollah; Davati, Ali; Kamalinejad, Mohammad; Faghihzadeh, Sograt

2013-01-01

Background: Hemorrhoids complaint is one of the most common problems in most society, especially in Asian countries. Current drug treatment protocols cannot cure the disease, and they are palliative. According to Persian traditional medicine, Commiphora Mukul (CM) resin is a medication choice. Aim: This randomized study was undertaken to evaluate the efficacy and safety of crude CM resin compared to a combination of lactolose and anti-hemorrhoid (LandA) in patients with uncomplicated hemorrhoids grade 1 and 2. Materials and Methods: This trial was carried out on 99 patients with hemorrhoids, in Ghaem and Imam Reaza Hospitals of the Mashhad University of Medical Sciences, Iran. They randomly received CM 3 g/d for 4 weeks (as study group) or LandA (Lactolose syrup in laxative dose for 1 month and anti-hemorrhoid suppository daily for 10 days) as control group. Subjective and objectives variables including painful defecation, flatulence, constipation, gastro-esophageal reflux (GER), dyspepsia, proctorrhagia, anal protrusion, and colonoscopic grading were assessed before, immediately after, and 4 weeks after the treatment period. An intent-to-treat analysis was used. Safety was assessed with evaluation of clinical adverse effects by common toxicity criteria version 4.0. Forty-nine patients were assigned randomly to receive LandA and 50 to receive CM. After 4 weeks, flatulence, dyspepsia, GER, and colonoscopic grading scores significantly decreased in study group, whereas in control group constipation, painful defecation, and proctorrhagia showed better but not significant improvement. After 4-weak follow-up, the rate of constipation, and proctorrhagia also showed significantly improvement in study group. Constipation and proctorrhagia in control group recurred significantly in 4-week follow-up than after the treatment, whereas this recurrence in test group was not seen. Conclusion: CM was more effective than LandA in 4-week treatment of patients with uncomplicated

Patient-Provider Interactions Affect Symptoms in Gastroesophageal Reflux Disease: A Pilot Randomized, Double-Blind, Placebo-Controlled Trial.

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Michelle L Dossett

Full Text Available It is unclear whether the benefits that some patients derive from complementary and integrative medicine (CIM are related to the therapies recommended or to the consultation process as some CIM provider visits are more involved than conventional medical visits. Many patients with gastrointestinal conditions seek out CIM therapies, and prior work has demonstrated that the quality of the patient-provider interaction can improve health outcomes in irritable bowel syndrome, however, the impact of this interaction on gastroesophageal reflux disease (GERD is unknown. We aimed to assess the safety and feasibility of conducting a 2 x 2 factorial design study preliminarily exploring the impact of the patient-provider interaction, and the effect of an over-the-counter homeopathic product, Acidil, on symptoms and health-related quality of life in subjects with GERD.24 subjects with GERD-related symptoms were randomized in a 2 x 2 factorial design to receive 1 either a standard visit based on an empathic conventional primary care evaluation or an expanded visit with questions modeled after a CIM consultation and 2 either Acidil or placebo for two weeks. Subjects completed a daily GERD symptom diary and additional measures of symptom severity and health-related quality of life.There was no significant difference in GERD symptom severity between the Acidil and placebo groups from baseline to follow-up (p = 0.41, however, subjects who received the expanded visit were significantly more likely to report a 50% or greater improvement in symptom severity compared to subjects who received the standard visit (p = 0.01. Total consultation length, perceived empathy, and baseline beliefs in CIM were not associated with treatment outcomes.An expanded patient-provider visit resulted in greater GERD symptom improvement than a standard empathic medical visit. CIM consultations may have enhanced placebo effects, and further studies to assess the active components of this

Two-dimensional random arrays for real time volumetric imaging

DEFF Research Database (Denmark)

Davidsen, Richard E.; Jensen, Jørgen Arendt; Smith, Stephen W.

1994-01-01

real time volumetric imaging system, which employs a wide transmit beam and receive mode parallel processing to increase image frame rate. Depth-of-field comparisons were made from simulated on-axis and off-axis beamplots at ranges from 30 to 160 mm for both coaxial and offset transmit and receive......Two-dimensional arrays are necessary for a variety of ultrasonic imaging techniques, including elevation focusing, 2-D phase aberration correction, and real time volumetric imaging. In order to reduce system cost and complexity, sparse 2-D arrays have been considered with element geometries...... selected ad hoc, by algorithm, or by random process. Two random sparse array geometries and a sparse array with a Mills cross receive pattern were simulated and compared to a fully sampled aperture with the same overall dimensions. The sparse arrays were designed to the constraints of the Duke University...

Effect of the omega-3 fatty acid plus vitamin E supplementation on subjective global assessment score, glucose metabolism, and lipid concentrations in chronic hemodialysis patients.

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Asemi, Zatollah; Soleimani, Alireza; Bahmani, Fereshteh; Shakeri, Hossein; Mazroii, Navid; Abedi, Fatemeh; Fallah, Melika; Mohammadi, Ali Akbar; Esmaillzadeh, Ahmad

2016-02-01

This study was conducted to determine the effects of omega-3 fatty acid plus vitamin E supplementation on subjective global assessment (SGA) score and metabolic profiles in chronic hemodialysis (HD) patients. This randomized double-blind placebo-controlled clinical trial was conducted among 120 chronic HD patients. Participants were randomly divided into four groups to receive: (i) 1250 mg/day omega-3 fatty acid containing 600 mg eicosapentaenoic acid and 300 mg docosahexaenoic acid + vitamin E placebo (n = 30), (ii) 400 IU/day vitamin E + omega-3 fatty acids placebo (n = 30), (iii) 1250 mg omega-3 fatty acids/day + 400 IU/day vitamin E (n = 30), and (iv) omega-3 fatty acids placebo + vitamin E placebo (n = 30) for 12 wk. Fasting blood samples were taken at baseline and after 12-wk intervention to measure metabolic profiles. Patients who received combined omega-3 fatty acids and vitamin E supplements compared with vitamin E, omega-3 fatty acids, and placebo had significantly decreased SGA score (p acids plus vitamin E supplementation for 12 wk among HD patients had beneficial effects on SGA score and metabolic profiles. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

[Deep needling and shallow needling at three acupoints around ear for subjective tinnitus: a randomized controlled trial].

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Yin, Tao; Ni, Jinxia; Zhu, Wenzeng

2015-10-01

To compare the effective differences between deep needling and shallow needling at three acupoints around ear for subjective tinnitus. Fifty patients with subjective tinnitus were randomized divided into a deep needling group and a shallow needling group, 25 cases in each group. Twenty-two patients in the deep needling group and 20 patients in the shallow needling group were brought into statistic in the end. In the two groups, the three acupoints around ear and distal acupoints were both selected. The acupoints of the affected side such as Yifeng (TE 17), Tinghui (GB 2), Ermen (TE 21), Zhigou (TE 6), Zhongzhu (TE 3) and Hegu (LI 4) were adopted. Yifeng (TE 17), Tinghui (GB 2) and Ermen (TE 21) were acupunctured 30-38 mm in the deep needling group and 15-20 mm in the shallow needling group. The other acupoints were conventionally acupunctured in the two groups. The needles were retained for 30 min,once a day and five times a week for all patients. The treatment was continuously for 4 weeks in the two groups. Tinnitus handicap inventory (THI) scores, tinnitus grades and visual analogue scale (VAS) for tinnitus sound levels were observed before and after treatment, and the effects of the two groups were compared. The total effective rate in the deep needling group was 59.1% (13/22), and it was better than 20.0% (4/20) in the shallow needling group (P deep needling, group, the THI score, tinnitus grade and the VAS score were improved than those before treatment (all P shallow needling group, the three above indices before and after treatment were not different in statistical significance (all P > 0.05). After treatment, all the three indices in the deep needling group were superior to those in the shallow needling group (all P shallow needling at the three acupoints.

Comparison of 3 Different Teaching Methods for a Behavioral Therapy Program for Female Overactive Bladder: A Randomized Controlled Trial.

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Gezginci, Elif; Iyigun, Emine; Yilmaz, Sercan

The purpose of this study was to compare the effect of 3 instructional methods for behavioral therapy on lower urinary tract symptom (LUTS) severity and health-related quality of life (HRQOL) in women with overactive bladder. Single-center, parallel-group, randomized, clinical trial. The sample comprised 60 women diagnosed with overactive bladder. The study setting was a university-based female urology clinic in Ankara, Turkey; data were collected from November 2012 to May 2013. Eligible participants were ambulatory women 18 years or older with predominant overactive bladder and urge urinary incontinence (UI) symptoms, with or without stress UI symptoms. Subjects were randomized into 4 groups based on educational intervention; group 1 received structured verbal instruction plus a leaflet, group 2 received structured verbal instruction, group 3 received a leaflet alone, and group 4 received usual care that included unstructured verbal counseling about continence care. The primary outcome measures were Incontinence Impact Questionnaire-7 (IIQ-7) and Urinary Distress Inventory-6 (UDI-6) scores. We also measured changes in UI-specific HRQOL scores via the Urinary Incontinence Quality of Life Instrument (I-QOL). All outcomes were measured before and 6 to 8 weeks after the interventions. The Wilcoxon test was used to identify differences in LUTS severity and HRQOL before and after the educational intervention. The Kruskall-Wallis test was used to compare differences among the groups. The severity of LUTS and UI-specific quality of life assessed by the IIQ-7, UDI-6, and I-QOL scores significantly improved after training in all 4 groups (P women with overactive bladder and urge UI.

Clinical Efficacy of Traditional Chinese Medicine, Suan Zao Ren Tang, for Sleep Disturbance during Methadone Maintenance: A Randomized, Double-Blind, Placebo-Controlled Trial

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Chan, Yuan-Yu; Chen, Yi-Hung; Yang, Szu-Nian; Lo, Wan-Yu; Lin, Jaung-Geng

2015-01-01

Methadone maintenance therapy is an effective treatment for opiate dependence, but more than three-quarters of persons receiving the treatment report sleep quality disturbances. In this double-blind, randomized, controlled trial, we recruited 90 individuals receiving methadone for at least one month who reported sleep disturbances and had Pittsburgh Sleep Quality Index (PSQI) scores > 5. The purpose of this study was to determine whether Suan Zao Ren Tang, one of the most commonly prescribed traditional Chinese medications for treatment of insomnia, improves subjective sleep among methadone-maintained persons with disturbed sleep quality. Ninety patients were randomly assigned to intervention group (n = 45) and placebo group (n = 45), and all participants were analyzed. Compared with placebo treatment, Suan Zao Ren Tang treatment for four weeks produced a statistically significant improvement in the mean total PSQI scores (P = 0.007) and average sleep efficiency (P = 0.017). All adverse events (e.g., lethargy, diarrhea, and dizziness) were mild in severity. Suan Zao Ren Tang is effective for improving sleep quality and sleep efficiency among methadone-maintained patients with sleep complaints. PMID:26346534

Clinical Efficacy of Traditional Chinese Medicine, Suan Zao Ren Tang, for Sleep Disturbance during Methadone Maintenance: A Randomized, Double-Blind, Placebo-Controlled Trial

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Yuan-Yu Chan

2015-01-01

Full Text Available Methadone maintenance therapy is an effective treatment for opiate dependence, but more than three-quarters of persons receiving the treatment report sleep quality disturbances. In this double-blind, randomized, controlled trial, we recruited 90 individuals receiving methadone for at least one month who reported sleep disturbances and had Pittsburgh Sleep Quality Index (PSQI scores > 5. The purpose of this study was to determine whether Suan Zao Ren Tang, one of the most commonly prescribed traditional Chinese medications for treatment of insomnia, improves subjective sleep among methadone-maintained persons with disturbed sleep quality. Ninety patients were randomly assigned to intervention group (n=45 and placebo group (n=45, and all participants were analyzed. Compared with placebo treatment, Suan Zao Ren Tang treatment for four weeks produced a statistically significant improvement in the mean total PSQI scores (P=0.007 and average sleep efficiency (P=0.017. All adverse events (e.g., lethargy, diarrhea, and dizziness were mild in severity. Suan Zao Ren Tang is effective for improving sleep quality and sleep efficiency among methadone-maintained patients with sleep complaints.

Orofacial manual therapy improves cervical movement impairment associated with headache and features of temporomandibular dysfunction: a randomized controlled trial.

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von Piekartz, Harry; Hall, Toby

2013-08-01

There is evidence that temporomandibular disorder (TMD) may be a contributing factor to cervicogenic headache (CGH), in part because of the influence of dysfunction of the temporomandibular joint on the cervical spine. The purpose of this randomized controlled trial was to determine whether orofacial treatment in addition to cervical manual therapy, was more effective than cervical manual therapy alone on measures of cervical movement impairment in patients with features of CGH and signs of TMD. In this study, 43 patients (27 women) with headache for more than 3-months and with some features of CGH and signs of TMD were randomly assigned to receive either cervical manual therapy (usual care) or orofacial manual therapy to address TMD in addition to usual care. Subjects were assessed at baseline, after 6 treatment sessions (3-months), and at 6-months follow-up. 38 subjects (25 female) completed all analysis at 6-months follow-up. The outcome criteria were: cervical range of movement (including the C1-2 flexion-rotation test) and manual examination of the upper 3 cervical vertebra. The group that received orofacial treatment in addition to usual care showed significant reduction in all aspects of cervical impairment after the treatment period. These improvements persisted to the 6-month follow-up, but were not observed in the usual care group at any point. These observations together with previous reports indicate that manual therapists should look for features of TMD when examining patients with headache, particularly if treatment fails when directed to the cervical spine. Copyright © 2013. Published by Elsevier Ltd.

Ultrasound-Guided Hyaluronic Acid Injections for Trigger Finger: A Double-Blinded, Randomized Controlled Trial.

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Liu, Ding-Hao; Tsai, Mei-Wun; Lin, Shan-Hui; Chou, Chen-Liang; Chiu, Jan-Wei; Chiang, Chao-Ching; Kao, Chung-Lan

2015-12-01

To investigate the effects of ultrasound-guided injections of hyaluronic acid (HA) versus steroid for trigger fingers in adults. Prospective, double-blinded, randomized controlled study. Tertiary care center. Subjects with a diagnosis of trigger finger (N=36; 39 affected digits) received treatment and were evaluated. Subjects were randomly assigned to HA and steroid injection groups. Both study medications were injected separately via ultrasound guidance with 1 injection. The classification of trigger grading, pain, functional disability, and patient satisfaction were evaluated before the injection and 3 weeks and 3 months after the injection. At 3 months, 12 patients (66.7%) in the HA group and 17 patients (89.5%) in the steroid group exhibited no triggering of the affected fingers (P=.124). The treatment results at 3 weeks and 3 months showed similar changes in the Quinnell scale (P=.057 and .931, respectively). A statistically significant interaction effect between group and time was found for visual analog scale (VAS) and Michigan Hand Outcome Questionnaire (MHQ) evaluation (Pinjection (steroid 0.5±1.1 vs HA 2.7±2.4; Pinjection of HA demonstrated promising results for the treatment of trigger fingers. The optimal frequency, dosage, and molecular weight of HA injections for trigger fingers deserve further investigation for future clinical applications. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Alternative outcomes create biased expectations regarding the received outcome: Evidence from event-related potentials.

Science.gov (United States)

Marciano, Déborah; Bentin, Shlomo; Deouell, Leon Y

2018-05-01

After choosing between uncertain options, one might get feedback on both the outcome of the chosen option and the outcome of the unchosen option (the alternative). Behavioral research has shown that in such cases people engage in outcome comparison, and that the alternative outcome influences the way one evaluates his own received outcome. Moreover, this influence differs whether one was responsible or not for the choice made. In two studies, we looked for the electrophysiological correlates of outcome comparison. Subjects chose one of two boxes shown on the screen, each box contained a gain or a loss. The alternative outcome was always revealed first, followed by the received outcome. In half of the trials the software picked one box instead of subjects. We tested whether the feedback-related negativity (FRN) and the P3 elicited by the received reflect outcome comparison. As expected, we found that the FRN and P3 were more positive when the received outcome was a gain (vs. a loss). The FRN and P3 were also sensitive to the value of the alternative outcome, but contrary to our predictions, they were more positive when the alternative outcome was a gain (vs. a loss). As the FRN and P3 are sensitive to expectations, we hypothesized that our findings might result from subjects' biased expectations: subjects might have wrongly believed that a good (bad) alternative outcome signaled a bad (good) received outcome. This hypothesis, coined as the Alternative Omen Effect, was confirmed in parallel in a series of behavioral experiments: people see an illusory negative correlation between the uncorrelated outcomes of choice options (reported in Marciano-Romm et al. (2016)). A challenge for future research will be to disentangle the effects of expectation from those of outcome comparison. Copyright © 2018 Elsevier Ltd. All rights reserved.

Effects of astrogaloside on the inflammation and immunity of renal failure patients receiving maintenance dialysis.

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Sun, Renlian; Ren, Haiwei; Wei, Jianxin

2018-03-01

Chronic renal failure is a type of clinical syndrome originating from chronic renal diseases. The aim of the study was to investigate the effect of astrogaloside on the inflammation and immunity of renal failure patients receiving maintenance dialysis. We randomly selected 92 renal failure patients receiving maintenance dialysis who were admitted to hospital for treatment between May, 2015 and April, 2016. Patients were randomly divided into the control (n=46) and observation (n=46) groups. Patients in the control group received the regular dialysis plus the basic treatment in Western medicine, while in the observation group, patients additionally received astrogaloside via intravenous injection as treatment. We compared the clinical efficacy of patients between the two groups, residual renal function (RRF), changes in urine volume, variations in inflammatory indicators [C-reaction protein (CRP), interleukin-6 (IL-6), IL-17, and tumor necrosis factor-α (TNF-α)] before and after treatment, and the levels of the thymus-dependent lymphocyte (T cells) subgroup (CD3 + , CD4 + , CD8 + and CD4 + /CD8 + ) in the immune system of patients after treatment. In the observation group, the total effective rate was significantly higher than that in the control group (Prenal failure patients receiving the maintenance dialysis, ameliorate the inflammatory responses, and enhance the immune function, thereby increasing the disease resistance of patients and improving the clinical symptoms.

Vascular effects of intravenous intralipid and dextrose infusions in obese subjects.

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Gosmanov, Aidar R; Smiley, Dawn D; Peng, Limin; Siquiera, Joselita; Robalino, Gonzalo; Newton, Christopher; Umpierrez, Guillermo E

2012-10-01

Hyperglycemia and elevated free fatty acids (FFA) are implicated in the development of endothelial dysfunction. Infusion of soy-bean oil-based lipid emulsion (Intralipid®) increases FFA levels and results in elevation of blood pressure (BP) and endothelial dysfunction in obese healthy subjects. The effects of combined hyperglycemia and high FFA on BP, endothelial function and carbohydrate metabolism are not known. Twelve obese healthy subjects received four random, 8-h IV infusions of saline, Intralipid 40 mL/h, Dextrose 10% 40 mL/h, or combined Intralipid and dextrose. Plasma levels of FFA increased by 1.03±0.34 mmol/L (p=0.009) after Intralipid, but FFAs remained unchanged during saline, dextrose, and combined Intralipid and dextrose infusion. Plasma glucose and insulin concentrations significantly increased after dextrose and combined Intralipid and dextrose (all, pdextrose infusion had neutral effects on BP and FMD. The co-administration of lipid and dextrose decreased FMD by 2.4%±2.1% (p=0.002) from baseline, but did not significantly increase systolic or diastolic BP. Short-term Intralipid infusion significantly increased FFA and BP; in contrast, FFA and BP were unchanged during combined infusion of Intralipid and dextrose. Combined Intralipid and dextrose infusion resulted in endothelial dysfunction similar to Intralipid alone. Copyright © 2012 Elsevier Inc. All rights reserved.

Effect of Vitamin D supplementation on glycemic parameters and progression of prediabetes to diabetes: A 1-year, open-label randomized study

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Mohammad Shafi Kuchay

2015-01-01

Full Text Available Background: Whether Vitamin D supplementation in prediabetes subjects prevents the development of diabetes is a matter of debate, and the results are inconsistent. This open-label, randomized study in subjects with prediabetes evaluated the effect of 12 months of Vitamin D supplementation on glycemic parameters and progression of prediabetes to diabetes in an ethnically homogeneous Kashmiri population. Materials and Methods: A total of 147 subjects were diagnosed as prediabetes out of which 137 subjects were randomized to receive in addition to standard lifestyle measures, either Vitamin D 60,000 IU weekly for 4 weeks and then 60,000 IU monthly (n = 69 or no Vitamin D (n = 68. Fasting plasma glucose (FPG, 2-h plasma glucose and A1C levels were estimated at 0, 6 and 12 months. Changes in FPG, 2-h plasma glucose, A1C level and the proportion of subjects developing diabetes were assessed among 129 subjects. Results: At 12 months, A1C levels were significantly lesser (5.7% ± 0.4% in the Vitamin D supplemented group when compared with non-Vitamin D supplemented (6.0% ± 0.3%. Similarly, FPG (97 ± 7 and 2-h plasma glucose (132 ± 16 were significantly less in Vitamin D supplemented group as compared with non-Vitamin D supplemented group (FPG = 116 ± 6 and 2-h plasma glucose = 157 ± 25 at 12 months. Nine out of 65 in non-Vitamin D supplemented and seven out of 64 in the Vitamin D supplemented group developed diabetes. Conclusions: Vitamin D supplementation in prediabetes subjects significantly lowered FPG, 2-h plasma glucose and A1C levels.

QT-interval effects of methadone, levomethadyl, and buprenorphine in a randomized trial.

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Wedam, Erich F; Bigelow, George E; Johnson, Rolley E; Nuzzo, Paul A; Haigney, Mark C P

2007-12-10

Levomethadyl acetate, methadone hydrochloride, and buprenorphine hydrochloride are equally effective treatments for opioid dependence. Each blocks the human ether-a-go-go-related gene (hERG)-associated channel in vitro and represents a risk for QT prolongation. To compare the effects of 3 known hERG-associated channel blockers on the corrected QT (QTc), we conducted a randomized, controlled trial of opioid-addicted subjects. We analyzed 12-lead electrocardiograms collected at baseline and every 4 weeks from 165 opioid-addicted participants in a 17-week randomized double-blind clinical trial of equally effective doses of levomethadyl, methadone, and buprenorphine at a major referral center. Analyses were limited to the 154 patients with a normal baseline QTc = (QT/ radical R-R) who had at least 1 subsequent in-treatment electrocardiogram. Patients were randomized to receive treatment with levomethadyl, methadone, or buprenorphine (hereinafter, levomethadyl, methadone, and buprenorphine groups, respectively). The prespecified end points were a QTc greater than 470 milliseconds in men (or >490 milliseconds in women), or an increase from baseline in QTc greater than 60 milliseconds. Baseline QTc was similar in the 3 groups. The levomethadyl and methadone groups were significantly more likely to manifest a QTc greater than 470 or 490 milliseconds (28% for the levomethadyl group vs 23% for the methadone group vs 0% for the buprenorphine group; P methadone group [odds ratio, 8.4; 95% confidence interval, 1.9-36.4]) compared with the buprenorphine group (2% of subjects; P methadone remained fixed over at least 8 weeks, the QTc continued to increase progressively over time (P = .08 for the levomethadyl group, P = .01 for the methadone group). Buprenorphine is associated with less QTc prolongation than levomethadyl or methadone and may be a safe alternative.

Tinnitus control by dopamine agonist pramipexole in presbycusis patients: a randomized, placebo-controlled, double-blind study.

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Sziklai, István; Szilvássy, Judit; Szilvássy, Zoltán

2011-04-01

Since the concept of tinnitus dopaminergic pathway emerged, studies have been proposed to investigate if dopaminergic agents influence tinnitus. We hypothesized that pramipexole, an agonist on D2/D3 receptors, may antagonize tinnitus in the presbycusis patients (in the frequency range of 250 to 8,000 Hz) in a dose schedule accepted for the treatment of Parkinson's disease in elderly people. We designed a randomized, prospective, placebo-controlled and double-blind trial. Forty presbycusis patients aged 50 years or older with subjective tinnitus were randomized to two groups (20 patients in both). Patients in the drug group took pramipexole over a period of 4 weeks according to a treatment schedule as follows: week 1, 0.088 mg t.i.d.; week 2, 0.18 mg t.i.d.; week 3, 0.7 mg t.i.d.; week 4, 0.18 mg t.i.d. over 3 days and 0.088 mg t.i.d. the rest of the week. Patients in the second group received placebo. Determination of subjective grading of tinnitus perception, the tinnitus handicap inventory (THI) questionnaire and electrocochleography (ECOG) examinations served as the end points. Subjective audiometry was used to produce secondary data. A significant improvement in tinnitus annoyance is found in the group treated with pramipexole versus placebo with respect to inhibition of tinnitus and a decrease of tinnitus loudness greater than 30 dB. However, neither ECOG nor subjective pure-tone threshold audiometry revealed any change in hearing threshold in response to either pramipexole or placebo. Pramipexole is an effective agent against subjective tinnitus associated with presbycusis at a dose schedule used for the treatment of Parkinson's disease. The drug did not change hearing threshold. Copyright © 2011 The American Laryngological, Rhinological, and Otological Society, Inc.

Comparison of two approaches in achieving smoking abstinence among patients in an outpatient clinic: a phase 2 randomized controlled trial

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Ka Yan Ho

2018-03-01

Full Text Available Background Having a disease and requiring medical attention present an excellent 'teachable moment' for smoking cessation interventions. However, nicotine is addictive and quitting is difficult, with a high rate of relapse, particularly among chronic smokers. Our previous smoking cessation projects in the community have revealed that many smokers who are reluctant to quit are interested in reducing the number of cigarettes they smoke per day. Therefore, smoking reduction may be an important alternative strategy for promoting smoking cessation. This Phase 2 randomized controlled trial of smokers who had medical follow-ups in an outpatient clinic compared the effectiveness of two approaches to smoking cessation: quitting immediately and cutting down to quit. Methods A total of 100 subjects were randomized into two groups, 50 in the quit immediately group, who received an intervention on abruptly quitting, and 50 in the cut down to quit group, who received an intervention on gradual reduction. All subjects were followed up at 6 and 12 months via telephone, and their smoking status was assessed. The primary outcomes were self-reported 7-day point prevalence of abstinence at 6 and 12 months. Intention-to-treat analysis was employed. Results On average, subjects had smoked 11.31 cigarettes per day over 37 years and 96% had mild nicotine dependence. At the 6-month follow-up, the self-reported quit rate of subjects in the quit immediately group was significantly higher than in the cut down to quit group (18.0% vs. 4.0%, p = 0.04. However, this difference was not significant at the 12-month follow-up (12.0% vs. 4.0%, p = 0.16. Conclusions These data suggest that quitting immediately might be more effective than cutting down to quit in smokers who need to quit sooner, such as those with diseases requiring medical attention. Nevertheless, the effectiveness of the cut down to quit approach requires further testing.

A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of neramexane in patients with moderate to severe subjective tinnitus

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Jastreboff Pawel J

2011-01-01

Full Text Available Abstract Background Neramexane is a new substance that exhibits antagonistic properties at α9α10 cholinergic nicotinic receptors and N-methyl-D-aspartate receptors, suggesting potential efficacy in the treatment of tinnitus. Methods A total of 431 outpatients with moderate to severe subjective tinnitus (onset 3-18 months before screening were assigned randomly to receive either placebo or neramexane mesylate (25 mg/day, 50 mg/day and 75 mg/day for 16 weeks, with assessment at 4-week intervals. The primary (intention-to-treat efficacy analysis was based on the change from baseline in Week 16 in the total score of the adapted German short version of the validated Tinnitus Handicap Inventory questionnaire (THI-12. Results Compared with placebo, the largest improvement was achieved in the 50 mg/d neramexane group, followed by the 75 mg/d neramexane group. This treatment difference did not reach statistical significance at the pre-defined endpoint in Week 16 (p = 0.098 for 50 mg/d; p = 0.289 for 75 mg/d neramexane, but consistent numerical superiority of both neramexane groups compared with placebo was observed. Four weeks after the end of treatment, THI-12 scores in the 50 mg/d group were significantly better than those of the controls. Secondary efficacy variables supported this trend, with p values of Conclusions This study demonstrated the safety and tolerability of neramexane treatment in patients with moderate to severe tinnitus. The primary efficacy variable showed a trend towards improvement of tinnitus suffering in the medium- and high-dose neramexane groups. This finding is in line with consistent beneficial effects observed in secondary assessment variables. These results allow appropriate dose selection for further studies. Trial Registration ClinicalTrials.gov NCT00405886

A randomized controlled trial of sucrose and/or pacifier as analgesia for infants receiving venipuncture in a pediatric emergency department

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Vandermeer Ben

2007-07-01

Full Text Available Abstract Background Although sucrose has been accepted as an effective analgesic agent for procedural pain in neonates, previous studies are largely in the NICU population using the procedure of heel lance. This is the first report of the effect of sucrose, pacifier or the combination thereof for the procedural pain of venipuncture in infants in the pediatric emergency department population. Methods The study design was a double (sucrose and single blind (pacifier, placebo-controlled randomized trial – factorial design carried out in a pediatric emergency department. The study population was infants, aged 0 – 6 months. Eighty-four patients were randomly assigned to one of four groups: a sucrose b sucrose & pacifier c control d control & pacifier. Each child received 2 ml of either 44% sucrose or sterile water, by mouth. The primary outcome measure: FLACC pain scale score change from baseline. Secondary outcome measures: crying time and heart rate change from baseline. Results Sucrose did not significantly reduce the FLACC score, crying time or heart rate. However sub-group analysis revealed that sucrose had a much greater effect in the younger groups. Pacifier use reduced FLACC score (not statistically significant, crying times (statistically significant but not heart rate. Subgroup analysis revealed a mean crying time difference of 76.52 seconds (p 3 months pacifier did not have any significant effect on crying time. Age adjusted regression analysis revealed that both sucrose and pacifier had significant effects on crying time. Crying time increased with both increasing age and increasing gestational age. Conclusion Pacifiers are inexpensive, effective analgesics and are easy to use in the PED for venipuncture in infants aged 0–3 months. The benefits of sucrose alone as an analgesic require further investigation in the older infant, but sucrose does appear to provide additional benefit when used with a pacifier in this age group. Trial

A randomized placebo-controlled trial of the efficacy of denosumab in Indian postmenopausal women with osteoporosis.

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Pitale, Shailesh; Thomas, Mathew; Rathi, Gaurav; Deshmukh, Vaishali; Kumar, Prasanna; Reddy, Sanjay; Shetty, Naresh; Kakar, Atul; Babhulkar, Sushrut; Mody, Bharat; Chacko, Jacob; Acharya, Sudeep; Joglekar, Sadhna; Halbe, Vipul; Kravitz, Barbara G; Waterhouse, Brian; Nino, Antonio J; Fitzpatrick, Lorraine A

2015-01-01

Osteoporosis is a serious condition affecting up to 50% of Indian postmenopausal women. Denosumab reduces bone resorption by targeting the receptor activator of nuclear factor-κB ligand. This study assessed the efficacy and safety of denosumab in Indian postmenopausal women with osteoporosis. In this double-blind, multicenter, phase 3 study, 250 Indian postmenopausal women aged 55 to 75 years (T-score -4.0 at the lumbar spine or total hip; serum 25(OH) D levels ≥20 ng/mL) were randomized to receive one subcutaneous dose of denosumab 60 mg or placebo. All subjects received oral calcium ≥1000 mg and vitamin D3 ≥ 400 IU daily. The primary end point was mean percent change in bone mineral density (BMD) at the lumbar spine from baseline to Month 6. Secondary end points included mean percent change from baseline in BMD at total hip, femoral neck, and trochanter at Month 6 and median percent change from baseline in bone turnover markers at Months 1, 3, and 6. Total 225 subjects (denosumab = 111, placebo = 114) completed the six-month study. Baseline demographics were similar between groups. A 3.1% (95% confidence interval, 1.9%, 4.2%) increase favoring denosumab versus placebo was seen for the primary end point (P Indian postmenopausal women.

Double-blind, randomized placebo-controlled clinical trial of benfotiamine for severe alcohol dependence.

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Manzardo, Ann M; He, Jianghua; Poje, Albert; Penick, Elizabeth C; Campbell, Jan; Butler, Merlin G

2013-12-01

Alcohol dependence is associated with severe nutritional and vitamin deficiency. Vitamin B1 (thiamine) deficiency erodes neurological pathways that may influence the ability to drink in moderation. The present study examines tolerability of supplementation using the high-potency thiamine analog, benfotiamine (BF), and BF's effects on alcohol consumption in severely affected, self-identified, alcohol dependent subjects. A randomized, double-blind, placebo-controlled trial was conducted on 120 non-treatment seeking, actively drinking, alcohol dependent men and women volunteers (mean age=47 years) from the Kansas City area who met DSM-IV-TR criteria for current alcohol dependence. Subjects were randomized to receive 600 mg benfotiamine or placebo (PL) once daily by mouth for 24 weeks with 6 follow-up assessments scheduled at 4 week intervals. Side effects and daily alcohol consumption were recorded. Seventy (58%) subjects completed 24 weeks of study (N=21 women; N=49 men) with overall completion rates of 55% (N=33) for PL and 63% (N=37) for BF groups. No significant adverse events were noted and alcohol consumption decreased significantly for both treatment groups. Alcohol consumption decreased from baseline levels for 9 of 10 BF treated women after 1 month of treatment compared with 2 of 11 on PL. Reductions in total alcohol consumption over 6 months were significantly greater for BF treated women (BF: N=10, -611 ± 380 standard drinks; PL: N=11, -159 ± 562 standard drinks, p-value=0.02). BF supplementation of actively drinking alcohol dependent men and women was well-tolerated and may discourage alcohol consumption among women. The results do support expanded studies of BF treatment in alcoholism. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Single-dose FTY720 pharmacokinetics, food effect, and pharmacological responses in healthy subjects

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Kovarik, John M; Schmouder, Robert; Barilla, Denise; Wang, Yibin; Kraus, Gerolf

2004-01-01

Aims FTY720 is a sphingosine-1-phosphate receptor agonist that redirects lymphocytes from the circulation to lymph nodes without impairing lymphocyte function. It is being developed as an immunomodulator for the prevention of acute rejection after organ transplantation. This study was performed to provide guidance on administration with respect to meals and to measure pharmacologic responses in healthy subjects. Methods In this randomized, two-period, crossover study, 14 healthy subjects received placebo on day −1 of each period with baseline circadian measurements of lymphocyte count and heart rate. Subjects subsequently received a single 1 mg oral dose of FTY720 on day 1 under fasting conditions and after a high fat meal. Blood FTY720 concentrations, lymphocyte count, and supine heart rate were assessed over an 8 day period after each FTY720 dose. The effect of food on FTY720 pharmacokinetics was assessed by standard bioequivalence testing. Results Both the peak concentration (0.65 ± 0.17 vs 0.64 ± 0.18 ng ml−1) and total exposure (AUC 149 ± 65 vs 139 ± 43 ng ml−1 h) did not differ significantly between fasting and fed states, respectively. The corresponding fed/fasting ratios and 90% confidence intervals were 1.00 (0.86, 1.17) for Cmax and 0.98 (0.86, 1.11) for AUC. Under both treatment conditions peripheral blood lymphocyte count decreased from baseline by 38 ± 9% over the first 2 days postdose and then increased towards predose values over the subsequent week. Whereas a circadian rhythm in supine heart rate was preserved in the presence of FTY720, the heart rate vs time curve was shifted downwards by 10% over the first day postdose and then recovered to prestudy values by days 3–5 postdose. These changes were asymptomatic. Conclusions Single 1 mg doses of FTY720 were well tolerated in healthy subjects and elicited a moderate decrease in peripheral blood lymphocyte count and a transient decrease in heart rate consistent with its pharmacological

Coping with missing data in phase III pivotal registration trials: Tolvaptan in subjects with kidney disease, a case study.

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Ouyang, John; Carroll, Kevin J; Koch, Gary; Li, Junfang

2017-07-01

Missing data cause challenging issues, particularly in phase III registration trials, as highlighted by the European Medicines Agency (EMA) and the US National Research Council. We explore, as a case study, how the issues from missing data were tackled in a double-blind phase III trial in subjects with autosomal dominant polycystic kidney disease. A total of 1445 subjects were randomized in a 2:1 ratio to receive active treatment (tolvaptan), or placebo. The primary outcome, the rate of change in total kidney volume, favored tolvaptan (P outline the analyses undertaken to address the issue of missing data thoroughly. "Tipping point analyses" were performed to explore how extreme and detrimental outcomes among subjects with missing data must be to overturn the positive treatment effect attained in those subjects who had complete data. Nonparametric rank-based analyses were also performed accounting for missing data. In conclusion, straightforward and transparent analyses directly taking into account missing data convincingly support the robustness of the preplanned analyses on the primary and secondary endpoints. Tolvaptan was confirmed to be effective in slowing total kidney volume growth, which is considered an efficacy endpoint by EMA, and in lessening the decline in renal function in patients with autosomal dominant polycystic kidney disease. Copyright © 2017 John Wiley & Sons, Ltd.

Efficacy of Traditional Chinese Medicine in Treatment and Prophylaxis of Radiation-Induced Oral Mucositis in Patients Receiving Radiotherapy: A Randomized Controlled Trial.

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Wang, Cong; Wang, Peiguo; Ouyang, Huaqiang; Wang, Jing; Sun, Lining; Li, Yanwei; Liu, Dongying; Jiang, Zhansheng; Wang, Bin; Pan, Zhanyu

2018-06-01

To estimate the efficacy of traditional Chinese medicine (Chining decoction, CHIN) for radiation-induced oral mucositis in patients with head and neck cancer. From May 2014 to December 2015, 70 consecutive patients were randomly assigned to receive CHIN (treatment group) or recombinant human epidermal growth factor (rhEGF) spray (control group) at a 1:1 ratio. CHIN was administered to treatment group from the first day of radiotherapy until the completion of radiotherapy. Simultaneously, the rhEGF spray was administered to control group on the oral mucosa of irradiated area. The clinical benefit was determined by gradation of mucositis (Common Terminology Criteria for Adverse Events v4.0), oral pain, and xerostomia (visual analysis scale) for each week during radiotherapy. Body mass index was evaluated before and after radiotherapy. Patients in the treatment group had prominent remission of oral pain and grade of mucositis on each observing point compared with those in control group ( P .05). CHIN presented an obvious advantage in preventing radiation-induced oral mucositis compared with rhEGF spray.

INvestigational Vertebroplasty Efficacy and Safety Trial (INVEST: a randomized controlled trial of percutaneous vertebroplasty

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Stout Lydia

2007-12-01

Full Text Available Abstract Background The treatment of painful osteoporotic vertebral compression fractures has historically been limited to several weeks of bed rest, anti-inflammatory and analgesic medications, calcitonin injections, or external bracing. Percutaneous vertebroplasty (the injection of bone cement into the fractured vertebral body is a relatively new procedure used to treat these fractures. There is increasing interest to examine the efficacy and safety of percutaneous vertebroplasty and to study the possibility of a placebo effect or whether the pain relief is from local anesthetics placed directly on the bone during the vertebroplasty procedure. Methods/Designs Our goal is to test the hypothesis that patients with painful osteoporotic vertebral compression fractures who undergo vertebroplasty have less disability and pain at 1 month than patients who undergo a control intervention. The control intervention is placement of local anesthesia near the fracture, without placement of cement. One hundred sixty-six patients with painful osteoporotic vertebral compression fractures will be recruited over 5 years from US and foreign sites performing the vertebroplasty procedure. We will exclude patients with malignant tumor deposit (multiple myeloma, tumor mass or tumor extension into the epidural space at the level of the fracture. We will randomly assign participants to receive either vertebroplasty or the control intervention. Subjects will complete a battery of validated, standardized measures of pain, functional disability, and health related quality of life at baseline and at post-randomization time points (days 1, 2, 3, and 14, and months 1, 3, 6, and 12. Both subjects and research interviewers performing the follow-up assessments will be blinded to the randomization assignment. Subjects will have a clinic visit at months 1 and 12. Spine X-rays will be obtained at the end of the study (month 12 to determine subsequent fracture rates. Our co

Risk of fatigue in cancer patients receiving anti-EGFR monoclonal antibodies: results from a systematic review and meta-analysis of randomized controlled trial.

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Zhu, Jianhong; Zhao, Wenxia; Liang, Dan; Li, Guocheng; Qiu, Kaifeng; Wu, Junyan; Li, Jianfang

2018-04-01

To evaluate the association between fatigue and anti-epidermal growth factor receptor monoclonal antibodies (anti-EGFR MAbs), we conducted the first meta-analysis to access the incidence and risk of fatigue associated with anti-EGFR MAbs. Electronic databases were searched for randomized controlled trials (RCTs) published up to February 2017. Eligible studies were selected according to PRISMA statement. Incidence rates, risk ratio (RRs), and 95% confidence intervals (CIs) were calculated using fixed-effects or random-effects models. Outcomes of quality were summarized in accordance with the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) methodology. Thirty-five RCTs (including 15,622 patients) were included; median follow-up ranged from 8.1 to 71.4 months, and the fatigue events were recorded and graded according to the Common Toxicity Criteria for Adverse Events version 2.0 or 3.0 in most of the included trials. For patients receiving anti-EGFR MAbs, the overall incidence of all-grade and high-grade fatigue was 54.1% and 10.5%, respectively. Compared with control, anti-EGFR MAbs significantly increased the risk of all-grade fatigue (RR 1.10, 95% CI, 1.05-1.14, moderate-quality evidence) and high-grade fatigue (RR 1.31, 95% CI, 1.19-1.45, moderate-quality evidence). No significant differences among subgroup analyses (anti-EGFR MAbs, tumor type, and median follow-up) on high-grade fatigue were observed. No evidence of publication bias was observed. The present study suggested that anti-EGFR MAbs may increase the risk of fatigue in cancer patients.

Interceptive treatment of palatal impaction of maxillary canines with rapid maxillary expansion: a randomized clinical trial.

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Baccetti, Tiziano; Mucedero, Manuela; Leonardi, Maria; Cozza, Paola

2009-11-01

Our aim in this prospective randomized clinical study was to assess the prevalence rate of eruption of palatally displaced canines, diagnosed at an early developmental stage with posteroanterior radiographs and consequently treated by rapid maxillary expansion. A sample of 60 subjects in the early mixed dentition with palatally displaced canines diagnosed on posteroanterior radiographs was enrolled in the trial. Their age range at the first observation (T1) was 7.6 to 9.6 years, with a prepubertal stage of skeletal maturity (CS1 or CS2). The 60 subjects were randomly allocated to the treatment group (TG, 35 subjects) or the no-treatment group (NTG, 25 subjects). The TG was treated with a banded rapid maxillary expander; after expansion, all patients were retained with the expander in place for 6 months. Thereafter, the expander was removed, and the patients wore a retention plate at night for a year. The NTG received no treatment. All subjects were reevaluated in the early permanent dentition (T2) (postpubertal CS4). The number of dropouts was recorded. The main outcome recorded at T2 was successful or unsuccessful eruption of the maxillary permanent canines. The starting forms at T1 for measurements on posteroanterior and panoramic films were compared in the 2 groups with the Mann-Whitney U test (P <0.05). The prevalence rates of successful and unsuccessful treatments in the TG were compared with those in NTG with chi-square tests (P <0.05). From T1 to T2, there were 3 dropouts in each group. The final sample comprised 32 subjects in the TG and 22 subjects in the NTG. No statistically significant differences were found for any variable at T1. The prevalence rates of successful eruption of the maxillary canines were 65.7% (21 subjects) in the TG and 13.6% (3 subjects) in the NTG. The comparison was statistically significant (chi-square = 12.4; P <0.001). Subjects with palatally displaced canines in the early mixed dentition do not have transverse deficiency of the

Hydrogen peroxide release kinetics into saliva from different whitening products: a double-blind, randomized clinical trial.

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Marques, Duarte Nuno da Silva; da Mata, António Duarte Sola Pereira; Silveira, João Miguel Lourenço; Marques, Joana Rita Oliveira Faria; Amaral, João Pedro de Almeida Rato; Guilherme, Nuno Filipe Rito Parada Marques

2012-02-01

The objective of this study is to compare salivary hydrogen peroxide (HP) release kinetics and potential toxicity of systemic exposure of four different whitening products. A double-blind, randomized controlled trial was conducted in a Portuguese dental faculty clinic. Two hundred forty volunteers were randomized to eight intervention groups. Participants were randomly assigned to receive active or placebo applications of one of four different products: Opalescence 10% PF™ (OPL), Vivastyle® 10%™ (VS10%), Vivadent Paint On Plus™ (PO+), and Trés White Supreme™ (TWS). Saliva collection was obtained by established methods at different times. The HP salivary content was determined by a photometric method. Salivary HP variations, total amount of salivary HP, and counts of subjects above the safe daily HP dose were the main outcome measures. All whitening systems significantly released HP to the saliva when compared to placebo, and all showed different release kinetics. The adaptable tray system (TWS) presented a risk increase of 37% [20-54%, 95% confidence interval] when compared to the other systems. The use of an adaptable tray whitening system with higher concentration of HP increases the toxicity potential.

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

Science.gov (United States)

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 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.

Olsalazine is contraindicated during pelvic radiation therapy: results of a double-blind, randomized clinical trial

International Nuclear Information System (INIS)

Martenson, James A.; Hyland, Glenn; Moertel, Charles G.; Mailliard, James A.; O'Fallon, Judith R.; Collins, Roger T.; Morton, Roscoe F.; Tewfik, Hamed H.; Moore, Randy L.; Frank, Albert R.; Urias, Rodolfo E.; Deming, Richard L.

1996-01-01

Purpose: A randomized clinical trial from Great Britain suggested a possible beneficial effect of acetylsalicylate in the prevention of radiation-induced bowel toxicity. Olsalazine is an orally administered drug designed to deliver 5-aminosalicylate to the large bowel with minimal systemic absorption. A randomized clinical trial was undertaken to assess the effectiveness of olsalazine in preventing acute diarrhea in patients receiving pelvic radiation therapy. Methods and Materials: Patients receiving pelvic radiation therapy were randomized, in double-blind fashion, to olsalazine 250 mg, two capsules twice daily, or an identical appearing placebo, two capsules twice daily. Patients were then evaluated weekly during radiation therapy for the primary study endpoint, diarrhea, as well as rectal bleeding, abdominal cramping, and tenesmus. Results: The study was closed early, after entry of 58 evaluable patients, when a preliminary analysis showed excessive diarrhea in patients randomized to olsalazine. The incidence and severity of diarrhea were worse in patients randomized to olsalazine (p 0.0036). Sixty percent of the patients randomized to olsalazine experienced Grade 3 or 4 diarrhea compared to only 14% randomized to placebo. There was also a trend toward higher incidence and greater severity of abdominal cramping in patients who were randomized to olsalazine (p = 0.084). Conclusion: Administration of olsalazine during pelvic radiation therapy resulted in an increased incidence and severity of diarrhea. Olsalazine is contraindicated in patients receiving pelvic radiation therapy

Sign Compute Resolve for Random Access

DEFF Research Database (Denmark)

Goseling, Jasper; Stefanovic, Cedomir; Popovski, Petar

2014-01-01

users collide. We measure the performance of the proposed method in terms of user resolution rate as well as overall throughput of the system. The results show that our approach significantly increases the performance of the system even compared to coded random access, where collisions are not wasted......We present an approach to random access that is based on three elements: physical-layer network coding, signature codes and tree splitting. Upon occurrence of a collision, physical-layer network coding enables the receiver to decode the sum of the information that was transmitted by the individual...

n-3 PUFA Esterified to Glycerol or as Ethyl Esters Reduce Non-Fasting Plasma Triacylglycerol in Subjects with Hypertriglyceridemia

DEFF Research Database (Denmark)

Hedengran, Anne; Szecsi, Pal B; Dyerberg, Jørn

2015-01-01

To date, treatment of hypertriglyceridemia with long-chain n-3 polyunsaturated fatty acids (n-3 PUFA) has been investigated solely in fasting and postprandial subjects. However, non-fasting triacylglycerols are more strongly associated with risk of cardiovascular disease. The objective of this st......To date, treatment of hypertriglyceridemia with long-chain n-3 polyunsaturated fatty acids (n-3 PUFA) has been investigated solely in fasting and postprandial subjects. However, non-fasting triacylglycerols are more strongly associated with risk of cardiovascular disease. The objective...... of this study was to investigate the effect of long-chain n-3 PUFA on non-fasting triacylglycerol levels and to compare the effects of n-3 PUFA formulated as acylglycerol (AG-PUFA) or ethyl esters (EE-PUFA). The study was a double-blinded randomized placebo-controlled interventional trial, and included 120...... subjects with non-fasting plasma triacylglycerol levels of 1.7-5.65 mmol/L (150-500 mg/dL). The participants received approximately 3 g/day of AG-PUFA, EE-PUFA, or placebo for a period of eight weeks. The levels of non-fasting plasma triacylglycerols decreased 28 % in the AG-PUFA group and 22 % in the EE...

Effects of Vitex agnus and Flaxseed on cyclic mastalgia: A randomized controlled trial.

Science.gov (United States)

Mirghafourvand, Mojgan; Mohammad-Alizadeh-Charandabi, Sakineh; Ahmadpour, Parivash; Javadzadeh, Yousef

2016-02-01

Evidence on the effect of Vitex agnus and Flaxseed on cyclical mastalgia is not enough. This study aimed to assess the efficacy of V. agnus and Flaxseed on cyclical mastalgia. This randomized controlled trial was conducted on 159 women referred to health centers of Tabriz, Iran. Subjects were allocated into three groups (n=53 per group) using block randomization. Group I received 25g daily Flaxseed powder and placebo of V. agnus; group II received daily 3.2-4.8mg V. agnus tablet and placebo of Flaxseed and control group received both placebo. Nominal day breast pain was applied at baseline, first, and second month after the intervention. Data was analyzed using general linear model. There was no statistical significant difference between the three groups in terms of socio-demographic characteristics and baseline values. The breast pain improved significantly in both intervention groups during the first and second month after intervention. Mean NDBP score was significantly lower than that in the control group at the first month after the intervention in the Flaxseed [adjusted mean difference: -3.1 (95% CI: -4.2 to -2.0)] and V. agnus groups [-3.3 (-4.3 to -2.2)] and the second month after the intervention in Flaxseed [-7.0 (-8.1 to -5.9)] and V. agnus groups [-6.4 (-7.5 to -5.3)]. Flaxseed and V. agnus are effective in short-term period in decreasing cyclical mastalgia. However, further studies are needed to examine the long-term effectiveness and sustainability of the effects after stopping the treatment in order to decide whether these alternative treatments are suitable to treat mastalgia or not. Copyright © 2015 Elsevier Ltd. All rights reserved.

Subject-driven titration of biphasic insulin aspart 30 twice daily is non-inferior to investigator-driven titration in Chinese patients with type 2 diabetes inadequately controlled with premixed human insulin: A randomized, open-label, parallel-group, multicenter trial.

Science.gov (United States)

Yang, Wenying; Zhu, Lvyun; Meng, Bangzhu; Liu, Yu; Wang, Wenhui; Ye, Shandong; Sun, Li; Miao, Heng; Guo, Lian; Wang, Zhanjian; Lv, Xiaofeng; Li, Quanmin; Ji, Qiuhe; Zhao, Weigang; Yang, Gangyi

2016-01-01

The present study was to compare the efficacy and safety of subject-driven and investigator-driven titration of biphasic insulin aspart 30 (BIAsp 30) twice daily (BID). In this 20-week, randomized, open-label, two-group parallel, multicenter trial, Chinese patients with type 2 diabetes inadequately controlled by premixed/self-mixed human insulin were randomized 1:1 to subject-driven or investigator-driven titration of BIAsp 30 BID, in combination with metformin and/or α-glucosidase inhibitors. Dose adjustment was decided by patients in the subject-driven group after training, and by investigators in the investigator-driven group. Eligible adults (n = 344) were randomized in the study. The estimated glycated hemoglobin (HbA1c) reduction was 14.5 mmol/mol (1.33%) in the subject-driven group and 14.3 mmol/mol (1.31%) in the investigator-driven group. Non-inferiority of subject-titration vs investigator-titration in reducing HbA1c was confirmed, with estimated treatment difference -0.26 mmol/mol (95% confidence interval -2.05, 1.53) (-0.02%, 95% confidence interval -0.19, 0.14). Fasting plasma glucose, postprandial glucose increment and self-measured plasma glucose were improved in both groups without statistically significant differences. One severe hypoglycemic event was experienced by one subject in each group. A similar rate of nocturnal hypoglycemia (events/patient-year) was reported in the subject-driven (1.10) and investigator-driven (1.32) groups. There were 64.5 and 58.1% patients achieving HbA1c titration of BIAsp 30 BID was as efficacious and well-tolerated as investigator-titration. The present study supported patients to self-titrate BIAsp 30 BID under physicians' supervision.

Fatigue life prediction of Ni-base thermal solar receiver tubes

Energy Technology Data Exchange (ETDEWEB)

Hartrott, Philipp von; Schlesinger, Michael [Fraunhofer-Institut fuer Werkstoffmechanik (IWM), Freiburg im Breisgau (Germany); Uhlig, Ralf; Jedamski, Jens [DLR Deutsches Zentrum fuer Luft- und Raumfahrt e.V., Stuttgart (Germany)

2010-07-01

Solar receivers for tower type Solar Thermal Power Plants are subjected to complex thermo-mechanical loads including fast and severe thermo-mechanical cycles. The material temperatures can reach more than 800 C and fall to room temperature very quickly. In order to predict the fatigue life of a receiver design, receiver tubes made of Alloy 625 with a wall thickness of 0.5 mm were tested in isothermal and thermo-cyclic experiments. The number of cycles to failure was in the range of 100 to 100,000. A thermo-mechanical fatigue life prediction model was set up. The model is based on the cyclic deformation of the material and the damage caused by the growth of fatigue micro cracks. The model reasonably predicts the experimental results. (orig.)

Generating equilateral random polygons in confinement III

International Nuclear Information System (INIS)

Diao, Y; Ernst, C; Montemayor, A; Ziegler, U

2012-01-01

In this paper we continue our earlier studies (Diao et al 2011 J. Phys. A: Math. Theor. 44 405202, Diao et al J. Phys. A: Math. Theor. 45 275203) on the generation methods of random equilateral polygons confined in a sphere. The first half of this paper is concerned with the generation of confined equilateral random walks. We show that if the selection of a vertex is uniform subject to the position of its previous vertex and the confining condition, then the distributions of the vertices are not uniform, although there exists a distribution such that if the initial vertex is selected following this distribution, then all vertices of the random walk follow this same distribution. Thus in order to generate a confined equilateral random walk, the selection of a vertex cannot be uniform subject to the position of its previous vertex and the confining condition. We provide a simple algorithm capable of generating confined equilateral random walks whose vertex distribution is almost uniform in the confinement sphere. In the second half of this paper we show that any process generating confined equilateral random walks can be turned into a process generating confined equilateral random polygons with the property that the vertex distribution of the polygons approaches the vertex distribution of the walks as the polygons get longer and longer. In our earlier studies, the starting point of the confined polygon is fixed at the center of the sphere. The new approach here allows us to move the starting point of the confined polygon off the center of the sphere. (paper)

The effect of counseling on anxiety after traumatic childbirth in nulliparous women; a single blind randomized clinical trial

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Mahnaz Azizi

2010-09-01

Full Text Available Background: Traumatic birthing mothers may expose more susceptible to experiences posttraumatic mental disorder such as anxiety. This study aimed to determine the effect of midwifery counseling intervention on the anxiety level after traumatic childbirth of primiparous women.Methods: In a randomized control trial 180 woman who had experienced traumatic childbirth based on DSM-IV criteria have been selected. The subjects were randomly divided into an intervention (n=90 and control (n=90 groups. The intervention group received midwifery counseling during two sessions and control group just received routin health care after childbirth. Both groups were followed up with partial – blind technique and compared 4-6 weeks and 3 months post partum. The data were analyzed using descriptive statistics by SPSS software. Results: Demographic characteristics, pregnancy complications and social support level were the same in both groups. In addition, there was no significant difference between two groups according to stress, depression and anxiety level before intervention (P>0.05. There was significant difference between two groups in anxiety level after 4-6 weeks and 3 months followup (P<0.001.Conclusion: Findings of this research shows that performing midwifery-counseling program may have significant effect on decreasing of anxiety level after traumatic childbirth.

Randomized Comparison of Dry Dressings Versus Hydrogel in Management of Radiation-Induced Moist Desquamation

International Nuclear Information System (INIS)

Macmillan, Maureen S.; Wells, Mary; MacBride, Sheila; Raab, Gillian M.; Munro, Alastair; MacDougall, Hugh

2007-01-01

Purpose: We present the results of a randomized controlled clinical trial that evaluated the effect of a hydrogel or dry dressing on the time to healing of moist desquamation after radiotherapy to the head-and-neck, breast, or anorectal areas. Methods and Materials: A total of 357 patients were randomized before radiotherapy to receive simple dry dressings (Tricotex) or a hydrogel (Intrasite), with Tricotex as a secondary dressing. Patients were instructed to use their dressings from the onset of moist desquamation, if it occurred. Results: Of the 357 patients, 100 (28%) developed moist desquamation. The time to healing was significantly prolonged (hazard ratio, 0.64; 95% confidence interval, 0.42-0.99), in patients assigned to gel dressings. No evidence was found that gel dressings had a significant impact on subjectively reported skin symptoms. Conclusion: The results of this study have not supported the routine use of hydrogels in the care of patients with moist desquamation and suggests that the healing times are prolonged, without any improvement in patient comfort

Evaluation of pregnancy rates of Bos indicus cows subjected to different synchronization ovulation protocols using injectable progesterone or an intravaginal device

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Jefferson Tadeu Campos

2016-12-01

Full Text Available This study evaluated the pregnancy rate in Nelore cows (Bos indicus that were subjected to fixed-time artificial insemination (FTAI using different protocols consisting of injectable progesterone (P4 or an intravaginal device (impregnated with P4. Multiparous cows 72-84 months in age, 30-45 days postpartum, were selected on the basis of the absence of a corpus luteum (CL and follicles < 8 mm after transrectal palpation and ultrasound examinations. On a random day of the estrus cycle (D0, the selected animals (n = 135 were randomly assigned to one of three experimental groups (n = 45 each. Group I (injectable P4/FTAI 36 hours received 250 mg of injectable P4 and 2 mg EB on D0; on D7, they received 500 µg of cloprostenol; on D8, 300 IU of eCG and 1 mg of EB were administered; and finally, FTAI was performed 36 hours after the application of EB. Group II (injectable P4/FTAI 48 hours received the same protocol as Group I, except that the FTAI was performed 48 hours after ovulation induction. The animals of Group III (Control/CIDR received a conventional protocol for FTAI using an intravaginal device (D0: P4 and 2 mg EB; D8: device removal, 500 µg cloprostenol, 300 IU eCG, 1 mg EB; and FTAI performed 48 hours after removal of the device. The results showed that cows synchronized with the conventional protocol for FTAI (Control/CIDR had a higher pregnancy rate (60 %, 27/45 than those synchronized with an injectable P4/FTAI 36 hours (33.33 %; 15/45, P = 0.010. However, the group receiving injectable P4 group/FTAI 48 hours had a similar pregnancy rate (48.9 %; 22/45; P = 0.290 when compared to both the group receiving the conventional protocol and that receiving injectable P4/FTAI 36 hours (P = 0.134. Although the injectable P4 may affect pregnancy rate with the FTAI performed in 36 hours, we found similar pregnancy rates from cows inseminated 48 hours after induction ovulation, considering injectable or intravaginal P4. Therefore, we suggest that

Bromocriptine and insulin sensitivity in lean and obese subjects

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L Bahler

2016-11-01

Full Text Available Bromocriptine is a glucose-lowering drug, which was shown to be effective in obese subjects with insulin resistance. It is usually administered in the morning. The exact working mechanism of bromocriptine still has to be elucidated. Therefore, in this open-label randomized prospective cross-over mechanistic study, we assessed whether the timing of bromocriptine administration (morning vs evening results in different effects and whether these effects differ between lean and obese subjects. We studied the effect of bromocriptine on insulin sensitivity in 8 lean and 8 overweight subjects using an oral glucose tolerance test. The subjects used bromocriptine in randomized cross-over order for 2 weeks in the morning and 2 weeks in the evening. We found that in lean subjects, bromocriptine administration in the evening resulted in a significantly higher post-prandial insulin sensitivity as compared with the pre-exposure visit (glucose area under the curve (AUC 742 mmol/L * 120 min (695–818 vs 641 (504–750, P = 0.036, AUC for insulin did not change, P = 0.575. In obese subjects, both morning and evening administration of bromocriptine resulted in a significantly higher insulin sensitivity: morning administration in obese: insulin AUC (55,900 mmol/L * 120 min (43,236–96,831 vs 36,448 (25,213–57,711, P = 0.012 and glucose AUC P = 0.069; evening administration in obese: glucose AUC (735 mmol/L * 120 min (614–988 vs 644 (568–829, P = 0.017 and insulin AUC, P = 0.208. In conclusion, bromocriptine increases insulin sensitivity in both lean and obese subjects. In lean subjects, this effect only occurred when bromocriptine was administrated in the evening, whereas in the obese, insulin sensitivity increased independent of the timing of bromocriptine administration.

Pen needle design influences ease of insertion, pain, and skin trauma in subjects with type 2 diabetes.

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Præstmark, Kezia A; Jensen, Morten L; Madsen, Nils B; Kildegaard, Jonas; Stallknecht, Bente M

2016-01-01

Pen needles used for subcutaneous injections have gradually become shorter, thinner and more thin walled, and thereby less robust to patient reuse. Thus, different needle sizes, alternative tip designs and needles resembling reuse were tested to explore how needle design influences ease of insertion, pain and skin trauma. 30 subjects with injection-treated type 2 diabetes and body mass index 25-35 kg/m 2 were included in the single-blinded study. Each subject received abdominal insertions with 18 different types of needles. All needles were tested twice per subject and in random order. Penetration force (PF) through the skin, pain perception on 100 mm visual analog scale, and change in skin blood perfusion (SBP) were quantified after the insertions. Needle diameter was positively related to PF and SBP (ptrend relation. Lack of needle lubrication and small 'needle hooks' increased PF and SBP (pskin and in polyurethane rubber were linearly related, and pain outcome was dependent of SBP increase. The shape and design of a needle and the needle tip affect ease of insertion, pain and skin trauma. Relations are seen across different data acquisition methods and across species, enabling needle performance testing outside of clinical trials. NCT02531776; results.

Lansoprazole 15 mg once daily for 14 days is effective for treatment of frequent heartburn: results of 2 randomized, placebo-controlled, double-blind studies.

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Kushner, Pamela R; Snoddy, Andrew M; Gilderman, Larry; Peura, David A

2009-07-01

To investigate the efficacy and safety of a 14-day treatment period with lansoprazole 15 mg for frequent heartburn in patients who are likely to select a nonprescription medication before consulting a prescriber. Adults with untreated frequent heartburn > or = 2 days a week over the past month were recruited for 2 identical multicenter, double-blind studies conducted with a 1-week screening and heartburn medication washout, a 1-week placebo run-in, a 2-week placebo-controlled treatment, and a 1-week placebo follow-up. After the washout and placebo run-in, subjects were randomly assigned to receive lansoprazole 15 mg or placebo once daily for 14 days in a double-blind fashion. Antacid tablets were permitted as rescue medication. Endpoints included percentage of 24-hour days without heartburn (primary), percentage of night-times without heartburn, and percentage of subjects without heartburn during day 1 of treatment (secondary endpoints). Data were collected daily via an interactive voice response system. In studies 1 and 2, 282 and 288 subjects, respectively, were randomly assigned to lansoprazole, and 282 in each study received placebo. The mean percentage of days without heartburn was greater among lansoprazole recipients compared with placebo recipients (P heartburn and no heartburn during day 1 of the 14-day treatment. Adverse events were infrequent and were similar for lansoprazole and placebo groups. During the 14-day treatment period in a population with frequent heartburn who were likely to select a medication without consulting a prescriber, lansoprazole 15 mg once daily showed rapid and sustained effectiveness throughout a 24-hour period and was well tolerated.

Evaluation of silodosin in comparison to tamsulosin in benign prostatic hyperplasia: a randomized controlled trial.

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Pande, Satabdi; Hazra, Avijit; Kundu, Anup Kumar

2014-01-01

Benign prostatic hyperplasia (BPH) is the most common cause of lower urinary tract symptoms in elderly men. Selective alfa1-adrenergic antagonists are now first-line drugs in the medical management of BPH. We conducted a single-blind, parallel group, randomized, controlled trial to compare the effectiveness and safety of the new alfa1-blocker silodosin versus the established drug tamsulosin in symptomatic BPH. Ambulatory male BPH patients, aged above 50 years, were recruited on the basis of International Prostate Symptom Score (IPSS). Subjects were randomized in 1:1 ratio to receive either tamsulosin 0.4 mg controlled release or silodosin 8 mg once daily after dinner for 12 weeks. Primary outcome measure was reduction in IPSS. Proportion of subjects who achieved IPSS tamsulosin were analyzed. Final IPSS at 12-week was significantly less than baseline for both groups. However, groups remained comparable in terms of IPSS at all visits. There was a significant impact on sexual function (assessed by IPSS sexual function score) in silodosin arm compared with tamsulosin. Prostate size and uroflowmetry parameters did not change. Both treatments were well-tolerated. Retrograde ejaculation was encountered only with silodosin and postural hypotension only with tamsulosin. Silodosin is comparable to tamsulosin in the treatment of BPH in Indian men. However, retrograde ejaculation may be troublesome for sexually active patients.

Influence of Isometric Exercise Training on Quadriceps Muscle Architecture and Strength in Obese Subjects with Knee Osteoarthritis

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Waleed S Mahmoud

2017-03-01

Full Text Available Obese individuals have reduced quadriceps muscle strength relative to body mass that may increase the rate of progression of knee osteoarthritis (OA. The purpose of this study was to evaluate the effects of isometric exercise training on quadriceps muscle architecture and strength in obese subjects with knee osteoarthritis. Methods: Fortyfour obese male subjects aged 40–65 years diagnosed with knee osteoarthritis were randomly assigned into group A (n=32 and group B (n=12. Group A subjects performed a 12-week isometric exercise program. Group B subjects did not participate in any exercise program and maintained their ordinary activities for the same period. Both groups received the same conventional physical therapy program including hot packs and therapeutic ultrasonic. Muscle thickness, pennation angles and fascicle length of the vastus lateralis (VL muscle of the affected knee were measured at rest by B-mode ultrasonography. Maximal voluntary isometric knee extension torque (MVIC of the affected knee was measured using an isokinetic dynamometer. Knee pain and function were evaluated using visual analogue pain scale (VAS and Western Ontario and McMaster Universities Arthritis Index (WOMAC. All variables were evaluated before and the end of the intervention period for both groups. Results: at the end of the program, group A subjects showed significant improvements compared with group B subjects regarding MVIC and muscle architecture parameters (p<0.05. Also, there was significant improvement in post-test VAS and WOMAC scores in group A subjects compared to group B subjects (p<0.05. Conclusion: A 12-week quadriceps isometric training program improves knee pain and quadriceps muscle strength and architecture in obese subjects with knee OA. These results indicate that isometric training should be regarded as a proper exercise intervention for obese patients with knee OA.

Pre-Meal Effect of Whey Proteins on Metabolic Parameters in Subjects with and without Type 2 Diabetes: A Randomized, Crossover Trial

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Ann Bjørnshave

2018-01-01

Full Text Available Diabetic dyslipidemia with elevated postprandial triglyceride (TG responses is characteristic in type 2 diabetes (T2D. Diet and meal timing can modify postprandial lipemia (PPL. The impact of a pre-meal of whey proteins (WP on lipid metabolism is unidentified. We determined whether a WP pre-meal prior to a fat-rich meal influences TG and apolipoprotein B-48 (ApoB-48 responses differentially in patients with and without T2D. Two matched groups of 12 subjects with and without T2D accomplished an acute, randomized, cross-over trial. A pre-meal of WP (20 g or water (control was consumed 15 min before a fat-rich meal (supplemented with 20 g WP in case of water pre-meal. Postprandial responses were examined during a 360-min period. A WP pre-meal significantly increased postprandial concentrations of insulin (P < 0.0001, glucagon (P < 0.0001 and glucose-dependent insulinotropic peptide (GIP (P < 0.0001 in subjects with and without T2D. We detected no effects of the WP pre-meal on TG, ApoB-48, or non-esterified fatty acids (NEFA responses to the fat-rich meal in either group. Paracetamol absorption i.e. gastric emptying was delayed by the WP pre-meal (P = 0.039. In conclusion, the WP pre-meal induced similar hormone and lipid responses in subjects with and without T2D. Thus, the WP pre-meal enhanced insulin, glucagon and GIP responses but did not influence lipid or glucose responses. In addition, we demonstrated that a WP pre-meal reduced gastric emptying in both groups.

Efficacy of Water Resistance Therapy in Subjects Diagnosed With Behavioral Dysphonia: A Randomized Controlled Trial.

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Guzman, Marco; Jara, Rodrigo; Olavarria, Christian; Caceres, Paloma; Escuti, Geordette; Medina, Fernanda; Medina, Laura; Madrid, Sofia; Muñoz, Daniel; Laukkanen, Anne-Maria

2017-05-01

The purpose of the present study was to determine the efficacy of water resistance therapy (WRT) in a long-term period of voice treatment in subjects diagnosed with voice disorders. Twenty participants, with behavioral dysphonia, were randomly assigned to one of two treatment groups: (1) voice treatment with WRT, and (2) voice treatment with tube phonation with the distal end in air (TPA). Before and after voice therapy, participants underwent aerodynamic, electroglottographic, acoustic, and auditory-perceptual assessments. The Voice Handicap Index and self-assessment of resonant voice quality were also performed. The treatment included eight voice therapy sessions. For the WRT group, the exercises consisted of a sequence of five phonatory tasks performed with a drinking straw submerged 5 cm into water. For the TPA, the exercises consisted of the same phonatory tasks, and all of them were performed into the same straw but the distal end was in air. Wilcoxon test showed significant improvements for both groups for Voice Handicap Index (decrease), subglottic pressure (decrease), phonation threshold pressure (decrease), and self-perception of resonant voice quality (increase). Improvement in auditory-perceptual assessment was found only for the TPA group. No significant differences were found for any acoustic or electroglottographic variables. No significant differences were found between WRT and TPA groups for any variable. WRT and TPA may improve voice function and self-perceived voice quality in individuals with behavioral dysphonia. No differences between these therapy protocols should be expected. Copyright © 2017 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Liposomal bupivacaine decreases pain following retropubic sling placement: a randomized placebo-controlled trial.

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Mazloomdoost, Donna; Pauls, Rachel N; Hennen, Erin N; Yeung, Jennifer Y; Smith, Benjamin C; Kleeman, Steven D; Crisp, Catrina C

2017-11-01

Midurethral slings are commonly used to treat stress urinary incontinence. Pain control, however, may be a concern. Liposomal bupivacaine is a local anesthetic with slow release over 72 hours, demonstrated to lower pain scores and decrease narcotic use postoperatively. The purpose of this study was to examine the impact of liposomal bupivacaine on pain scores and narcotic consumption following retropubic midurethral sling placement. This randomized, placebo-controlled trial enrolled women undergoing retropubic midurethral sling procedures with or without concomitant anterior or urethrocele repair. Subjects were allocated to receive liposomal bupivacaine (intervention) or normal saline placebo injected into the trocar paths and vaginal incision at the conclusion of the procedure. At the time of drug administration, surgeons became unblinded, but did not collect outcome data. Participants remained blinded to treatment. Surgical procedures and perioperative care were standardized. The primary outcome was the visual analog scale pain score 4 hours after discharge home. Secondary outcomes included narcotic consumption, time to first bowel movement, and pain scores collected in the mornings and evenings until postoperative day 6. The morning pain item assessed "current level of pain"; the evening items queried "current level of pain," "most intense pain today," "average pain today with activity," and "average pain today with rest." Likert scales were used to measure satisfaction with pain control at 1- and 2-week postoperative intervals. Sample size calculation deemed 52 subjects per arm necessary to detect a mean difference of 10 mm on a 100-mm visual analog scale. To account for 10% drop out, 114 participants were needed. One hundred fourteen women were enrolled. After 5 exclusions, 109 cases were analyzed: 54 women received intervention, and 55 women received placebo. Mean participant age was 52 years, and mean body mass index was 30.4 kg/m 2 . Surgical and

A Receiver-Initiated Collision-Avoidance Protocol for Multi-Channel Networks

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2001-01-01

00-00-2001 to 00-00-2001 4. TITLE AND SUBTITLE A Receiver-Initiated Collision-Avoidance Protocol for Multi-Channel Netowrks 5a. CONTRACT NUMBER...images. 14. ABSTRACT 15. SUBJECT TERMS 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF ABSTRACT 18. NUMBER OF PAGES 10 19a. NAME OF RESPONSIBLE

Bioequivalence of eslicarbazepine acetate from two different sources of its active product ingredient in healthy subjects.

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Falcão, Amílcar; Lima, Ricardo; Sousa, Rui; Nunes, Teresa; Soares-da-Silva, Patrício

2013-06-01

To compare the bioavailability (BA) and pharmacokinetic (PK) properties and to demonstrate the bioequivalence (BE) between two active product ingredient (API) sources of eslicarbazepine acetate (ESL) in healthy volunteers. Forty healthy male and female subjects aged 18-40 years were randomized to treatment with 400 or 800 mg ESL marketed (MF) formulation [current active pharmaceutical ingredient (API) source] and 400 or 800 mg ESL to-be-marketed (TBM) formulation (new API source) under a gender-balanced, two-period, two-sequence crossover open-label study design. Subjects were assigned to receive either 400 or 800 mg ESL dose strengths, and each was randomly administered on two occasions--either a single oral tablet of MF or a single oral tablet of TBM--separated by a washout period of at least 7 days. Formulations were to be considered bioequivalent if, for both 400 or 800 mg ESL dosage strengths, the test (TBM)/reference (MF) geometric mean ratios (GMR) and 90% confidence intervals (90% CI) of the area under the plasma concentration-time curve (AUC) and peak plasma concentration (Cmax) were within the predetermined range of 80-125%. Test/reference GMR (90% CI) for the Cmax and AUC was respectively 100% (94-109%) and 96% (94-98%) following 400 mg ESL and 100% (95-105%) and 100% (97-103%) following 800 mg ESL. Oral tablet formulations of either 400 or 800 mg ESL from the new API source were found to be bioequivalent to the corresponding marketed Zebinix® formulation according to the regulatory definition of bioequivalence.

Effects of extra virgin olive oil supplementation at two different low doses on lipid profile in mild hypercholesterolemic subjects: a randomised clinical trial.

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Violante, B; Gerbaudo, L; Borretta, G; Tassone, F

2009-11-01

Olive oil, the principal fat of Mediterranean Diet, is known to improve several cardiovascular risk factors at relatively high doses together with intensive modifications of dietary habits. Since this is hard to obtain in the long term, an intervention with encapsulated oil supplements might be more feasible. Aim of this preliminary study was to investigate the effects of the supplementation of a moderate amount of encapsulated extra virgin olive oil vs a lower dose in mildly hypercholesterolemic subjects, as part of their established diet, on blood lipid profile. A prospective randomized study was performed. Thirty-four mildly hypercholesterolemic subjects [age, mean+/-SD: 46+/-7 yr; total cholesterol (TC): 235+/-28 mg/dl] were randomly assigned to receive 2 g (group A) or 4 g (group B) per os of extra-virgin olive oil for 3 months. TC, triglycerides (TG), LDL cholesterol, HDL cholesterol, apolipoprotein A1 (Apo-AI), apolipoprotein B (Apo-B), and atherogenic index of plasma (AIP) were evaluated at the beginning and at the end of the study. In group B, but not in group A, a significant reduction of Apo-B values (7%) was observed; TG concentrations showed a trend towards reduction and Apo-A1 values a trend towards increase (9%). A significant decrease in Apo-B/Apo-A1 ratio (pgroup B. Extra virgin olive oil supplementation significantly decreased AIP from baseline in group B (pvirgin olive oil, in mildly hypercholesterolemic subjects, is associated to favorable modifications of the plasmatic lipid profile.

Adjunctive Systemic Antimicrobial Therapy vs Asepsis in Conjunction with Guided Tissue Regeneration: A Randomized, Controlled Clinical Trial.

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Abu-Ta'a, Mahmoud

2016-01-01

This randomized clinical trial compares the usefulness of adjunctive antibiotics, while strict asepsis was followed during periodontal surgery involving guided tissue regeneration. Two groups of 20 consecutive patients each with advanced periodontal disease were randomly assigned to treatment. They displayed one angular defect each with an intrabony component ≥3 mm, probing pocket depth and probing attachment level (PAL) ≥7 mm. Test group included 13 males, mean age 60 years, treated with enamel matrix derivative (EMD) and demineralized freeze-dried bone allograft with modified papilla preservation technique, received oral amoxicillin 1 gm, 1 hour preoperatively and 2 gm for 2 days postoperatively. Control group included 10 males, mean age 57 years, treated with EMD and demineralized freeze-dried bone allograft with modified papilla preservation technique, received no antibiotics. Outcome measures were clinical attachment level (CAL) gain, residual periodontal pocket depth (res. PD), gingival recession (GR), bleeding on probing (BOP), adverse events and postoperative complications. Patients were followed up to 12 months after periodontal surgery involving guided tissue regeneration. There were no significant differences between both groups for CAL gain, res. PD, GR, BOP nor other clinical parameters, though patients' subjective perception of postoperative discomfort was significantly smaller in the group receiving antibiotics. Antibiotics do not provide significant advantages concerning clinical periodontal parameters nor concerning postoperative infections in case of proper asepsis. It does, on the contrary, reduce postoperative discomfort. Regarding the results of this study, adjunc-tive systemic antibiotics in combination with guided tissue regeneration may be useful in reducing postoperative discomfort but may not be helpful for improving periodontal regeneration outcomes.

A cluster randomized trial of provider-initiated (Opt-out) HIV counseling and testing of tuberculosis patients in South Africa

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Pope, Diana S.; DeLuca, Andrea N.; Kali, Paula; Hausler, Harry; Sheard, Carol; Hoosain, Ebrahim; Chaudhary, Mohammed A.; Celentano, David D.; Chaisson, Richard E.

2008-01-01

Objective To determine whether implementation of provider-initiated HIV counseling would increase the proportion of tuberculosis patients that received HIV counseling and testing. Design Cluster-randomized trial with clinic as unit of randomization Setting Twenty, medium-sized primary care TB clinics in the Nelson Mandela Metropolitan Municipality, Port Elizabeth, Eastern Cape Province, South Africa Subjects A total of 754 adults (≥ 18 years) newly registered as tuberculosis patients the twenty study clinics Intervention Implementation of provider-initiated HIV counseling and testing. Main outcome measures Percentage of TB patients HIV counseled and tested. Secondary Percentage of patients HIV test positive and percentage of those that received cotrimoxazole and who were referred for HIV care. Results A total of 754 adults newly registered as tuberculosis patients were enrolled. In clinics randomly assigned to implement provider-initiated HIV counseling and testing, 20.7% (73/352) patients were counseled versus 7.7% (31/402) in the control clinics (p = 0.011), and 20.2 % (n = 71) versus 6.5% (n = 26) underwent HIV testing (p = 0.009). Of those patients counseled, 97% in the intervention clinics accepted testing versus 79% in control clinics (p =0.12). The proportion of patients identified as HIV-infected in intervention clinics was 8.5% versus 2.5% in control clinics (p=0.044). Fewer than 40% of patients with a positive HIV test were prescribed cotrimoxazole or referred for HIV care in either study arm. Conclusions Provider-initiated HIV counseling significantly increased the proportion of adult TB patients that received HIV counseling and testing, but the magnitude of the effect was small. Additional interventions to optimize HIV testing for TB patients urgently need to be evaluated. PMID:18520677