The Effect of Patient Choice of Intervention on Health Outcomes

PubMed Central

Clark, Noreen M.; Janz, Nancy K.; Dodge, Julia A.; Mosca, Lori; Lin, Xihong; Long, Qi; Little, Roderick J; Wheeler, John R.C.; Keteyian, Steven; Liang, Jersey

2008-01-01

Background Patient preference may influence intervention effects, but has not been extensively studied. Randomized controlled design (N=1075) assessed outcomes when women (60 years +) were given a choice of two formats of a program to enhance heart disease management. Methods Randomization to "no choice" or "choice" study arms. Further randomization of "no choice” to: 1) Group intervention program format, 2) Self-Directed program format, 3) Control Group. "Choice" arm selected their preferred program format. Baseline, four, twelve, and eighteen month follow-up data collected. Two analyses: health outcomes for choice compared to being randomized; and preference effect on treatment efficacy. Results Women who chose a format compared to being assigned a format had better psychosocial functioning at four months (p=0.02) and tended toward better physical functioning at twelve months (p=0.07). At eighteen months women who chose versus being assigned a format had more symptoms measured as: number (p=0.004), frequency (p=0.006) and bother (p=0.004). At four months women who preferred the Group format had better psychosocial functioning when assigned the Group format than when they were assigned the Self Directed format (p=0.03). At eighteen months women preferring a Group format had more symptoms: number (p=0.001), frequency (p=0.001), bother (p=0.001) when assigned the Group format than when assigned the Self Directed format. Conclusions Choice and preference for the Group format each enhanced psychosocial and physical functioning up to one year. Despite the preference for Group format, over the longer term (eighteen months) cardiac symptoms were fewer when assigned the Self-Directed format. PMID:18515187

[Randomized controlled trial on the effectiveness of Corpitolinol 60 in the prevention of pressure sores in patients undergoing surgery].

PubMed

Chiari, Paolo; Giorgi, Sabina; Ugolini, Daniela; Montanari, Morena; Giudanella, Pietro; Gramantieri, Antonella; Collesi, Franca; Pau, Michelina; Smaldone, Maddalena; Matarasso, Maddalena; Mazzini, Cinzia; Russo, Francesca; Gazineo, Domenica; Fontana, Mirella; Taddia, Patrizia

2012-01-01

Randomized controlled trial on the effectiveness of Corpitolinol 60 in the prevention of pressure sores in surgical patients. The risk of pressure sores in surgical patients is widely recognised. The Corpitolinol 60 (Sanyréne®) applied on compressed areas seems to reduce the risk of pressure sores. To assess the efficacy of Corpitolinol 60 in preventing pressure sores in the operatory theatre. The open label randomized clinical trial was conducted in 5 operating theatres of Northen Italy. Patients were randomized to receive Corpitolinol 60 in areas undergoing compression. Experimental group and controls were treated with usual measures for preventing pressure sores. The lesions were staged according to NPUAP up to 24 hours after surgery. Three-hundred-one patients were randomized (155 in the Sanyréne® group and 143 controls). The main variables predictive of pressure sores risk (ASA class, sex, age, duration of the surgery, and BMI) were comparable across groups. At the end of the surgery 71 patients (23.8%) in the experimental group and 47 controls (30.8%) had a pressure sore (p 0.006; RR 1.81 IC95% 1.17-2.79). Twelve and 24 hours after surgery the differences between groups were not significant. The aim of reducing pressure sores was not reached for patients treated with Corpitolinol 60.

Effectiveness of short-term, enhanced, infection control support in improving compliance with infection control guidelines and practice in nursing homes: a cluster randomized trial.

PubMed

Gopal Rao, G; Jeanes, A; Russell, H; Wilson, D; Atere-Roberts, E; O'Sullivan, D; Donaldson, N

2009-10-01

In this prospective cluster randomized controlled trial we evaluated the impact of short-term provision of enhanced infection control support on infection control practice in nursing homes in South London. Twelve nursing homes were recruited, six each in intervention (300 residents) and control (265 residents) groups. Baseline observations of hand hygiene facilities, environmental cleanliness and safe disposal of clinical waste showed poor compliance in both groups. Post-intervention observations showed improvement in both groups. There was no statistical difference between the two groups in the compliance for hand hygiene facilities (P=0.69); environmental cleanliness (P=0.43) and safe disposal of clinical waste (P=0.96). In both groups, greatest improvement was in compliance with safe disposal of clinical waste and the least improvement was in hand hygiene facilities. Since infection control practice improved in intervention and control groups, we could not demonstrate that provision of short-term, enhanced, infection control support in nursing homes had a significant impact in infection control practice.

The effect of integration of HIV care and treatment into antenatal care clinics on mother-to-child HIV transmission and maternal outcomes in Nyanza, Kenya: results from the SHAIP cluster randomized controlled trial

PubMed Central

Washington, Sierra; Owuor, Kevin; Turan, Janet M.; Steinfeld, Rachel L.; Onono, Maricianah; Shade, Starley B.; Bukusi, Elizabeth A.; Ackers, Marta L.; Cohen, Craig R.

2015-01-01

Background Many HIV-infected pregnant women identified during antenatal care do not enroll in long-term HIV care, resulting in deterioration of maternal health and continued risk of HIV transmission to infants. Methods We performed a cluster-randomized trial to evaluate the effect of integrating HIV care into ANC clinics in rural Kenya. Twelve facilities were randomized to provide either integrated services (ANC, PMTCT, and HIV care delivered in the ANC clinic; n=6 intervention facilities), or standard ANC services (including PMTCT and referral to a separate clinic for HIV care; n=6 control facilities). Results There were high patient attrition rates over the course of this study. Among study participants who enrolled in HIV care, there was twelve month follow up data for 256/611 (41.8%) women, and postpartum data for only 325/1172 (28%) women. By 9 months of age, 382/568 (67.3%) infants at intervention sites and 338/594 (57.0%) at control sites had tested for HIV (OR 1.45, 95% CI 0.71-2.82); 7.3% of infants tested HIV-positive at intervention sites compared to 8.0% of infants at control sites (OR 0.89, 95% CI 0.56-1.43). The composite clinical/immunologic progression into AIDS was similar in both arms (4.9% vs. 5.1 %, OR 0.83, 95% CI 0.41 - 1.68). Conclusions Despite the provision of integrated services, patient attrition was substantial in both arms, suggesting barriers beyond lack of service integration. Integration of HIV services into the ANC clinic was not associated with a reduced risk HIV transmission to infants and did not appear to affect short-term maternal health outcomes. PMID:25886930

Effect of UV irradiation on cutaneous cicatrices: a randomized, controlled trial with clinical, skin reflectance, histological, immunohistochemical and biochemical evaluations.

PubMed

Due, Eva; Rossen, Kristian; Sorensen, Lars Tue; Kliem, Anette; Karlsmark, Tonny; Haedersdal, Merete

2007-01-01

The aim of this study was to examine the effect of ultraviolet (UV) irradiation on human cutaneous cicatrices. In this randomized, controlled study, dermal punch biopsy wounds served as a wound healing model. Wounds healed by primary or second intention and were randomized to postoperative solar UV irradiation or to no UV exposure. Evaluations after 5 and 12 weeks included blinded clinical assessments, skin reflectance measurements, histology, immunohistochemistry, and biochemical analyses of the N-terminal propeptide from procollagen-1, hydroxyproline, hydroxylysine, and proline. Twelve weeks postoperatively, UV-irradiated cicatrices healing by second intention: (i) were significantly pointed out as the most disfiguring; (ii) obtained significantly higher scores of colour, infiltration and cicatrix area; and (iii) showed significantly higher increase in skin-reflectance measurements of skin-pigmentation vs. non-irradiated cicatrices. No histological, immunohistochemical or biochemical differences were found. In conclusion, postoperative UV exposure aggravates the clinical appearance of cicatrices in humans.

Bench model surgical skill training improves novice ability to multitask: a randomized controlled study.

PubMed

Grierson, Lawrence; Melnyk, Megan; Jowlett, Nathan; Backstein, David; Dubrowski, Adam

2011-01-01

Skills training in simulation laboratories is becoming increasingly common. However, the educational benefit of these laboratories remains unclear. This study examined whether such training enables better performance on the simultaneous execution of technical skill and knowledge retention. Twenty-four novice trainees completed the elliptical excision on baseline testing. Following baseline testing twelve of the novices completed a technical practice (simulation training group) session, while the other twelve did not (control group). One week later, all participants returned for dual-task follow up testing in which they performed the excision while listening to a didactic lesson on the staging and treatment of cutaneous melanoma. The dual-tasking during the post test was standardized, whereby excision sutures 3 and 5 were performed alone (single), and sutures 4 and 6 were performed concurrently with the didactic lecture (dual). Seven additional trainees also participated as controls that were randomized to listen to the didactic lesson alone (knowledge retention alone group). Knowledge retention was assessed by a multiple choice questionnaire (MCQ). Technical performance was evaluated with computer and expert-based measures. Time to complete the performance improved among both groups completing the elliptical excision on follow-up testing (p<0.01). The simulation training group demonstrated superior hand motion performance on simultaneous didactic lesson testing (p<0.01). Novices from the no-training group performed statistically worse while suturing concurrently with the didactic lesson (p<0.01). The pretraining of novices in surgical skills laboratories leads to improved technical performance during periods of increased attention demands.

Single-blind randomized clinical trial to evaluate clinical and radiological outcomes after one year of immediate versus delayed implant placement supporting full-arch prostheses

PubMed Central

Pellicer-Chover, Hilario; Peñarrocha-Oltra, David; Bagán, Leticia; Fichy-Fernandez, Antonio J.; Canullo, Luigi

2014-01-01

Purpose: To evaluate and compare peri-implant health, marginal bone loss and success of immediate and delayed implant placement for rehabilitation with full-arch fixed prostheses. Material and Methods: The present study was a prospective, randomized, single-blind, clinical preliminary trial. Patients were randomized into two treatment groups. In Group A implants were placed immediately post-extraction and in Group B six months after extraction. The following control time-points were established: one week, six months and twelve months after loading. Measurements were taken of peri-implant crevicular fluid volume, plaque index, gingival retraction, keratinized mucosa, probing depth, modified gingival index and presence of mucositis. Implant success rates were evaluated for the two groups. The study sample included fifteen patients (nine women and six men) with a mean average age of 63.7 years. One hundred and forty-four implants were placed: 76 placed in healed sites and 68 placed immediately. Results: At the moment of prosthetic loading, keratinized mucosa width and probing depth were higher in immediate implants than delayed implants, with statistically significant differences. However, after six and twelve months, differences between groups had disappeared. Bone loss was 0.54 ± 0.39 mm for immediate implants and 0.66 ± 0.25 mm for delayed implants (p=0.201). No implants failed in either group. Conclusions: The present study with a short follow-up and a small sample yielded no statistically significant differences in implant success and peri-implant marginal bone loss between immediate and delayed implants with fixed full-arch prostheses. Peri-implant health showed no statistically significant differences for any of the studied parameters (crevicular fluid volume, plaque index, gingival retraction, keratinized mucosa, probing depth, modified gingival index and presence of mucositis) at the twelve-month follow-up. Key words:Immediate implants, delayed implants, peri-implant health, success rate. PMID:24316712

Open transinguinal preperitoneal mesh repair of inguinal hernia: a targeted systematic review and meta-analysis of published randomized controlled trials

PubMed Central

Sajid, Muhammad S.; Craciunas, L.; Singh, K.K.; Sains, P.; Baig, M.K.

2013-01-01

Objective: The objective of this article is to systematically analyse the randomized, controlled trials comparing transinguinal preperitoneal (TIPP) and Lichtenstein repair (LR) for inguinal hernia. Methods: Randomized, controlled trials comparing TIPP vs LR were analysed systematically using RevMan® and combined outcomes were expressed as risk ratio (RR) and standardized mean difference. Results: Twelve randomized trials evaluating 1437 patients were retrieved from the electronic databases. There were 714 patients in the TIPP repair group and 723 patients in the LR group. There was significant heterogeneity among trials (P < 0.0001). Therefore, in the random effects model, TIPP repair was associated with a reduced risk of developing chronic groin pain (RR, 0.48; 95% CI, 0.26, 0.89; z = 2.33; P < 0.02) without influencing the incidence of inguinal hernia recurrence (RR, 0.18; 95% CI, 0.36, 1.83; z = 0.51; P = 0.61). Risk of developing postoperative complications and moderate-to-severe postoperative pain was similar following TIPP repair and LR. In addition, duration of operation was statistically similar in both groups. Conclusion: TIPP repair for inguinal hernia is associated with lower risk of developing chronic groin pain. It is comparable with LR in terms of risk of hernia recurrence, postoperative complications, duration of operation and intensity of postoperative pain. PMID:24759818

Postcards in Persia: A Twelve to Twenty-four Month Follow-up of a Randomized Controlled Trial for Hospital-Treated Deliberate Self-Poisoning.

PubMed

Hassanian-Moghaddam, Hossein; Sarjami, Saeedeh; Kolahi, Ali-Asghar; Lewin, Terry; Carter, Gregory

2017-01-02

This study reports the outcomes, during follow-up, of a low-cost postcard intervention in a Randomized Control Trial of hospital-treated self-poisoning (n = 2300). The intervention was 9 postcards over 12 months (plus usual treatment) versus usual treatment. Three binary endpoints at 12-24 months (n = 2001) were: any suicidal ideation, suicide attempt, or self-cutting. There was a significant reduction in any suicidal ideation (RRR 0.20 CI 95% 0.13-0.27), (NNT 8, 6-13), and any suicide attempt (RRR 0.31, 0.06-0.50), (NNT 35, 19-195), in this non-western population. However, there was no effect on self-cutting (RRR -0.01, -1.05-0.51). Sustained, brief contact by mail may reduce some forms of suicidal behavior in self-poisoning patients during the post intervention phase.

Health and economic effects from linking bedside and outpatient tobacco cessation services for hospitalized smokers in two large hospitals: study protocol for a randomized controlled trial.

PubMed

Fellows, Jeffrey L; Mularski, Richard; Waiwaiole, Lisa; Funkhouser, Kim; Mitchell, Julie; Arnold, Kathleen; Luke, Sabrina

2012-08-01

Extended smoking cessation follow-up after hospital discharge significantly increases abstinence. Hospital smoke-free policies create a period of 'forced abstinence' for smokers, thus providing an opportunity to integrate tobacco dependence treatment, and to support post-discharge maintenance of hospital-acquired abstinence. This study is funded by the National Heart, Lung, and Blood Institute (1U01HL1053231). The Inpatient Technology-Supported Assisted Referral study is a multi-center, randomized clinical effectiveness trial being conducted at Kaiser Permanente Northwest (KPNW) and at Oregon Health & Science University (OHSU) hospitals in Portland, Oregon. The study assesses the effectiveness and cost-effectiveness of linking a practical inpatient assisted referral to outpatient cessation services plus interactive voice recognition (AR + IVR) follow-up calls, compared to usual care inpatient counseling (UC). In November 2011, we began recruiting 900 hospital patients age ≥18 years who smoked ≥1 cigarettes in the past 30 days, willing to remain abstinent postdischarge, have a working phone, live within 50 miles of the hospital, speak English, and have no health-related barriers to participation. Each site will randomize 450 patients to AR + IVR or UC using a 2:1 assignment strategy. Participants in the AR + IVR arm will receive a brief inpatient cessation consult plus a referral to available outpatient cessation programs and medications, and four IVR follow-up calls over seven weeks postdischarge. Participants do not have to accept the referral. At KPNW, UC participants will receive brief inpatient counseling and encouragement to self-enroll in available outpatient services. The primary outcome is self-reported thirty-day smoking abstinence at six months postrandomization for AR + IVR participants compared to usual care. Additional outcomes include self-reported and biochemically confirmed seven-day abstinence at six months, self-reported seven-day, thirty-day, and continuous abstinence at twelve months, intervention dose response at six and twelve months for AR + IVR recipients, incremental cost-effectiveness of AR + IVR intervention compared to usual care at six and twelve months, and health-care utilization and expenditures at twelve months for AR + IVR recipients compared to UC. This study will provide important evidence for the effectiveness and cost-effectiveness of linking hospital-based tobacco treatment specialists' services with discharge follow-up care. ClinicalTrials.gov: NCT01236079.

Aromatherapy for treatment of hypertension: a systematic review.

PubMed

Hur, Myung-Haeng; Lee, Myeong Soo; Kim, Chan; Ernst, Edzard

2012-02-01

The objective of this review is to systematically review the evidence for the effectiveness of aromatherapy in the treatment of high blood pressure. Twelve databases were searched from their inception through December 2009. Controlled trials testing aromatherapy in patients with hypertension of any origin that assessed blood pressure were considered. The selection of studies, data extraction and validations were performed independently by two reviewers. One randomized clinical trial (RCT) and four non-randomized controlled clinical trials (CCTs) met our inclusion criteria. The one RCT included tested the effects of aromatherapy as compared with placebo and showed significant reduction of systolic blood pressure and diastolic blood pressure. All of the four CCTs showed favourable effects of aromatherapy. However, all of the CCTs also had a high risk of bias. The existing trial evidence does not show convincingly that aromatherapy is effective for hypertension. Future studies should be of high quality with a particular emphasis on designing an adequate control intervention. © 2010 Blackwell Publishing Ltd.

Twelve-Week Exercise Influences Memory Complaint but not Memory Performance in Older Adults: A Randomized Controlled Study.

PubMed

Iuliano, Enzo; Fiorilli, Giovanni; Aquino, Giovanna; Di Costanzo, Alfonso; Calcagno, Giuseppe; di Cagno, Alessandra

2017-10-01

This study aimed to evaluate the effects of different types of exercise on memory performance and memory complaint after a 12-week intervention. Eighty community-dwelling volunteers, aged 66.96 ± 11.73 years, were randomly divided into four groups: resistance, cardiovascular, postural, and control groups (20 participants for each group). All participants were tested for their cognitive functions before and after their respective 12-week intervention using Rey memory words test, Prose memory test, and Memory Complaint Questionnaire (MAC-Q). Statistical analysis showed that the three experimental groups significantly improved MAC-Q scores in comparison with the control group (p < .05). The variation of MAC-Q scores and the variations of Rey and Prose memory tests scores were not correlated. These results indicate that the 12-week interventions exclusively influenced memory complaint but not memory performance. Further investigations are needed to understand the relation between memory complaint and memory performance, and the factors that can influence this relationship.

Chiasma failures and chromosome association in Rhoeo spathacea var. variegata.

PubMed

Lin, Y J

1982-01-01

In Rhoeo spathacea var. variegata (2n = 2x = 12), the most frequent meiotic configuration was the chain-of-12 chromosomes (36%) and the second most frequent was the ring-of-12 chromosomes (25.6%). All six possible two-chain situations and eleven of the twelve possible three-chain situations were observed. A maximum of five chains was observed in four cells. The size of chains ranged from on through twelve chromosomes. The mean number of chiasma failures was 1.36 +/- 0.07 per cell and 0.1133 per pair of chromosome arms. Because the observed frequencies of various configurations agree with the expected, which were calculated under the assumption that chiasma failure is equally likely at each of the twelve positions around the ring, it was concluded that chiasma failures occurred at random among the arm-positions. Due to the lengths of arm-pairs in the ring vary considerably, the randomness may mean that chiasma formation was restricted to small terminal regions on all chromosomes.

Randomized, single blind, controlled trial of inhaled glutathione vs placebo in patients with cystic fibrosis.

PubMed

Calabrese, C; Tosco, A; Abete, P; Carnovale, V; Basile, C; Magliocca, A; Quattrucci, S; De Sanctis, S; Alatri, F; Mazzarella, G; De Pietro, L; Turino, C; Melillo, E; Buonpensiero, P; Di Pasqua, A; Raia, V

2015-03-01

In cystic fibrosis (CF) the defective CF transmembrane conductance regulator protein may be responsible for the impaired transport of glutathione (GSH), the first line defense of the lung against oxidative stress. The aim of this single-blind, randomized, placebo-controlled trial was to evaluate the effect of inhaled GSH in patients with CF. 54 adult and 51 pediatric patients were randomized to receive inhaled GSH or placebo twice daily for 12 months. Twelve month treatment with inhaled GSH did not achieve our predetermined primary outcome measure of 15% improvement in FEV1%. Only in patients with moderate lung disease, 3, 6 and 9 months therapy with GSH resulted in a statistically significant increase of FEV1 values from the baseline. Moreover GSH therapy improved 6-minute walking test in pediatric population. GSH was well tolerated by all patients. Inhaled GSH has slight positive effects in CF patients with moderate lung disease warranting further study. ClinicalTrials.gov; No.: NCT01450267; URL: www.clinicaltrialsgov. Copyright © 2014 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

The Effects of Twelve Weeks of Tai Chi Practice on Anxiety in Stressed But Healthy People Compared to Exercise and Wait-List Groups-A Randomized Controlled Trial.

PubMed

Zheng, Shuai; Kim, Christine; Lal, Sara; Meier, Peter; Sibbritt, David; Zaslawski, Chris

2018-01-01

This randomized controlled trial was undertaken to determine whether 12 weeks of Tai Chi (TC) practice can reduce anxiety in healthy but stressed people. Fifty participants were randomized into TC (n=17), exercise (n=17), and wait-list (WL) groups (n=16). Outcome measures used were State Trait Anxiety Inventory, Perceived Stress Scale 14 (PSS14), blood pressure and heart rate variability, visual analogue scale (VAS), and Short Form 36. Significant improvements were observed from baseline for both TC and exercise groups for both state (p <0.01) and trait (p <0.01) anxiety, PSS14 (p <0.01), VAS (p <0.01), mental health domain (p <0.01), and vitality domain (p <0.01). Superior outcomes were also observed for TC when compared with WL for state and trait anxiety (p <0.01) and mental health domain (p <0.05). TC reduces stress levels in healthy individuals and provides a safer, cost effective, and less physically vigorous alternative to exercise. © 2017 Wiley Periodicals, Inc.

Effect of health education combining diet and exercise supervision in Chinese women with perimenopausal symptoms: a randomized controlled trial.

PubMed

Xi, S; Mao, L; Chen, X; Bai, W

2017-04-01

This study aimed to evaluate the effect of health education combining diet and exercise supervision on menopausal symptoms and diet/exercise habits. The randomized controlled study enrolled 60 patients with perimenopausal syndrome (Kupperman Menopause Index (KMI) score ≥15). The participants were randomized into either an intervention group (n = 30) or a control group (n = 30). Women were interviewed with questionnaires about perimenopausal symptoms, diet pattern and exercise habit. Their height and weight were measured. Women in the intervention group received health education, diet supervision and exercise supervision twice a week while those in the control group continued as normal. The total KMI score, scores of individual symptoms, diet pattern and exercise habit were measured after intervention. The total KMI score, the individual KMI scores for paresthesia, irritability, depression/suspicious, fatigue, arthralgia/myalgia, and palpitations of the intervention group were significantly lower compared with the control group after intervention. The intake of cereal, meat, fats and oils of the intervention group were significantly lower at week 12 compared with baseline. The percentage of women with a regular exercise habit was significantly higher in the intervention group than in the control group after intervention. Twelve weeks intervention of health education combining diet and exercise supervision could improve perimenopausal symptoms and help the patients establish good living habits.

LA Sprouts: A 12-Week Gardening, Nutrition, and Cooking Randomized Control Trial Improves Determinants of Dietary Behaviors.

PubMed

Davis, Jaimie N; Martinez, Lauren C; Spruijt-Metz, Donna; Gatto, Nicole M

2016-01-01

To evaluate the effect of an exploratory 12-week nutrition, cooking, and gardening trial (LA Sprouts) on preference for fruit and vegetables (FV); willingness to try FV; identification of FV; self-efficacy to garden, eat, and cook FV; motivation to garden, eat, and cook FV; attitudes toward FV; nutrition and gardening knowledge; and home gardening habits. Randomized controlled trial. Four elementary schools. Three hundred four predominately Hispanic/Latino third- through fifth-grade students were randomized to either the LA Sprouts group (n = 167 students) or control group (n = 137 students). Twelve-week after-school nutrition, cooking, and gardening intervention. Determinants of dietary behavior as measured by questionnaire at baseline and postintervention. Analyses of covariance. After the 12-week program, compared with controls, LA Sprouts participants improved scores for identification of vegetables (+11% vs +5%; P = .001) and nutrition and gardening knowledge (+14.5% vs -5.0%; P = .003), and were more likely to garden at home (+7.5% vs -4.4%; P = .003). The LA Sprouts program positively affected a number of determinants of dietary behaviors that suggest possible mechanisms by which gardening and nutrition education act to improve dietary intake and health outcomes. Copyright © 2016 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

The effects of healing abutments of different size and anatomic shape placed immediately in extraction sockets on peri-implant hard and soft tissues. A pilot study in foxhound dogs.

PubMed

López-López, Patricia J; Mareque-Bueno, Javier; Boquete-Castro, Ana; Aguilar-Salvatierra Raya, Antonio; Martínez-González, José M; Calvo-Guirado, José L

2016-01-01

The aim of this animal study was to compare the effects of narrow, concave-straight and wide anatomic healing abutments on changes to soft tissues and crestal bone levels around implants immediately placed into extraction sockets in foxhound dogs. Forty-eight titanium implants (Bredent Medical GMBH, Germany) of the same dimensions were placed in six foxhound dogs. They were divided into two groups (n = 24): test (implants with anatomic abutment) and control (implants with concave-straight abutment). The implants were inserted randomly in the post extraction sockets of P2 , P3 , P4, and M1 bilaterally in six dogs. After eight and twelve weeks, the animals were sacrificed and samples extracted containing the implants and the surrounding soft and hard tissues. Soft tissue and crestal bone loss (CBL) were evaluated by histology and histomorphometry. All implants were clinically and histologically osseointegrated. Healing patterns were examined microscopically at eight and twelve weeks. After eight and twelve weeks, for hard tissues, the distance from the implant shoulder to the first bone-to-implant contact (IS-C) was higher for control group in the lingual aspect with statistical significance (P < 0.05). For soft tissues (STL), the distance from the top of the peri-implant mucosa to the apical portion of the junction epithelium (PM-Je) was significantly less on the lingual aspect in the test group (with wider abutment) at eight and twelve weeks (P < 0.05). The distance from the top of the apical portion of the junction epithelium to the first bone-to-implant contact (Je-C) was significantly higher in the test group (wider abutment) in the lingual aspect at eight and twelve weeks (P < 0.05). There was no connective tissue contact with any abutment surface. Within the limitations of this animal study, anatomic healing abutments protect soft and hard tissues and reduce crestal bone resorption compared with concave-straight healing abutments. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A comparison of advanced overlay technologies

NASA Astrophysics Data System (ADS)

Dasari, Prasad; Smith, Nigel; Goelzer, Gary; Liu, Zhuan; Li, Jie; Tan, Asher; Koh, Chin Hwee

2010-03-01

The extension of optical lithography to 22nm and beyond by Double Patterning Technology is often challenged by CDU and overlay control. With reduced overlay measurement error budgets in the sub-nm range, relying on traditional Total Measurement Uncertainty (TMU) estimates alone is no longer sufficient. In this paper we will report scatterometry overlay measurements data from a set of twelve test wafers, using four different target designs. The TMU of these measurements is under 0.4nm, within the process control requirements for the 22nm node. Comparing the measurement differences between DBO targets (using empirical and model based analysis) and with image-based overlay data indicates the presence of systematic and random measurement errors that exceeds the TMU estimate.

Fundamental movement skills in preschoolers: a randomized controlled trial targeting object control proficiency.

PubMed

Donath, L; Faude, O; Hagmann, S; Roth, R; Zahner, L

2015-11-01

Adequately developed fundamental movement skills, particularly object control dimensions, are considered essential to learn more complex movement patterns and to increase the likelihood to successfully participate in organized and non-organized sports during later years. Thus, the present randomized controlled trial aimed at improving object control dimensions at an early state in a kindergarten setting. Catching, throwing, kicking, rolling and stationary dribbling were assessed via gross motor development 2 (TGMD-2) testing in 41 normally developed preschoolers. On a cluster-randomized basis [strata: age, sex and body mass index (BMI)], three kindergartens were randomly assigned to an intervention group (n = 22, INT, age: 4.6 ± 1.0 years; BMI: 16.2 ± 1.1 kg/m(2) ) and three to a control group (n = 19, CON: age: 4.5 ± 1.2 years; BMI: 16.8 ± 1.2 kg/m(2) ). Twelve structured training sessions were given within 6 weeks (12 sessions). The total training volume was 330 min. Moderate time × group interaction were observed for the total sum score (Δ+22%, P = 0.05) and dribbling (Δ+41%, P = 0.002). Adjusting for baseline differences analyses of covariance did not affect these results. Interestingly, likely to most likely practically worthwhile effects were detected for the total sum score, catching and dribbling. Object control dimensions such as dribbling and catching that apparently rely on rhythmical movement patterns and anticipatory eye-hand coordination seem to benefit from short-term object control training. These skills are considered important for successful team-sport participation and appropriate sportive motor development. © 2015 John Wiley & Sons Ltd.

Functional abnormalities in the cortical processing of sound complexity and musical consonance in schizophrenia: evidence from an evoked potential study

PubMed Central

2013-01-01

Background Previous studies have demonstrated functional and structural temporal lobe abnormalities located close to the auditory cortical regions in schizophrenia. The goal of this study was to determine whether functional abnormalities exist in the cortical processing of musical sound in schizophrenia. Methods Twelve schizophrenic patients and twelve age- and sex-matched healthy controls were recruited, and participants listened to a random sequence of two kinds of sonic entities, intervals (tritones and perfect fifths) and chords (atonal chords, diminished chords, and major triads), of varying degrees of complexity and consonance. The perception of musical sound was investigated by the auditory evoked potentials technique. Results Our results showed that schizophrenic patients exhibited significant reductions in the amplitudes of the N1 and P2 components elicited by musical stimuli, to which consonant sounds contributed more significantly than dissonant sounds. Schizophrenic patients could not perceive the dissimilarity between interval and chord stimuli based on the evoked potentials responses as compared with the healthy controls. Conclusion This study provided electrophysiological evidence of functional abnormalities in the cortical processing of sound complexity and music consonance in schizophrenia. The preliminary findings warrant further investigations for the underlying mechanisms. PMID:23721126

Effect of two laser photobiomodulation application protocols on the viability of random skin flap in rats

NASA Astrophysics Data System (ADS)

Martignago, C. C. S. M.; Tim, C. R.; Assis, L.; Neve, L. M. G.; Bossini, P. S.; Renno, A. C.; Avó, L. R. S.; Liebano, R. E.; Parizotto, N. A.

2018-02-01

Objective: to identify the best low intensity laser photobiomodulation application site to increase the viability of the cutaneous flap in rats. Methods: 18 male rats (Rattus norvegicus: var. Albinus, Rodentia Mammalia) were randomly distributed into 3 groups (n = 6). Group I (GI) was submitted to simulated laser photobiomodulation, group II (GII) was submitted to the laser photobiomodulation at three points in the flap cranial base, and group III (GIII) was submitted to laser photobiomodulation at twelve points distributed along the flap. All groups were irradiated with an Indium, Galium, Aluminum and Phosphorus diode laser (InGaAlP), 660 nm, with power of 50 mW, total energy of 12 J in continuous emission mode. The treatment started immediately after performing the cranial base random skin flap (dimension of 10X4 cm2 ) and reapplied every 24 hours, with a total of 5 applications. The animals were euthanized after the evaluation of the percentage of necrosis area and the material was collected for histological analysis on the 7th postoperative day. Results: GII animals presented a statistically significant decrease for the necrosis area when compared to the other groups, and a statistically significant increase in the quantification of collagen when compared to the control. We did not observe a statistical difference between the TGFβ and FGF expression in the different groups evaluated. Conclusion: the application of laser photobiomodulation at three points of the flap cranial base was more effective than at twelve points regarding the reduction of necrosis area.

[Clinical study on the effect of anti-gingivitis IgY toothpaste in control of gingivitis and dental plaque].

PubMed

Zhang, Wei; Feng, Xi-Ping; Tao, Dan-Ying; Chen, Jian-Fen

2016-08-01

To observe the effect of anti-gingivitis IgY toothpaste in control of gingivitis and plaque. The study was a double-blind, randomized, parallel-controlled clinical trail with a total of 100 subjects who were divided into two groups, experimental group and control group. The subjects in experimental group used anti-gingivitis IgY toothpaste to brush twice daily for 3 minutes, and the subjects in control group used none anti-gingivitis IgY toothpaste. The examiner recorded GI, PI and BOP index of all subjects at the baseline, 6-weeks and 12-weeks. SPSS21.0 software package was used for statistical analysis. Twelve weeks later, there were significant differences in GI and BOP between the two groups. Yet no significant difference was found in PI. Anti-gingivitis IgY toothpaste is effective in control of gingivitis.

Web-based physiotherapy for people moderately affected with Multiple Sclerosis; quantitative and qualitative data from a randomized, controlled pilot study.

PubMed

Paul, Lorna; Coulter, Elaine H; Miller, Linda; McFadyen, Angus; Dorfman, Joe; Mattison, Paul George G

2014-09-01

To explore the effectiveness and participant experience of web-based physiotherapy for people moderately affected with Multiple Sclerosis (MS) and to provide data to establish the sample size required for a fully powered, definitive randomized controlled study. A randomized controlled pilot study. Rehabilitation centre and participants' homes. Thirty community dwelling adults moderately affected by MS (Expanded Disability Status Scale 5-6.5). Twelve weeks of individualised web-based physiotherapy completed twice per week or usual care (control). Online exercise diaries were monitored; participants were telephoned weekly by the physiotherapist and exercise programmes altered remotely by the physiotherapist as required. The following outcomes were completed at baseline and after 12 weeks; 25 Foot Walk, Berg Balance Scale, Timed Up and Go, Multiple Sclerosis Impact Scale, Leeds MS Quality of Life Scale, MS-Related Symptom Checklist and Hospital Anxiety and Depression Scale. The intervention group also completed a website evaluation questionnaire and interviews. Participants reported that website was easy to use, convenient, and motivating and would be happy to use in the future. There was no statistically significant difference in the primary outcome measure, the timed 25ft walk in the intervention group (P=0.170), or other secondary outcome measures, except the Multiple Sclerosis Impact Scale (P=0.048). Effect sizes were generally small to moderate. People with MS were very positive about web-based physiotherapy. The results suggested that 80 participants, 40 in each group, would be sufficient for a fully powered, definitive randomized controlled trial. © The Author(s) 2014.

Effects of a mindfulness-based intervention on mindful eating, sweets consumption, and fasting glucose levels in obese adults: data from the SHINE randomized controlled trial

PubMed Central

Epel, Elissa S.; Kristeller, Jean; Moran, Patricia J.; Dallman, Mary; Lustig, Robert H.; Acree, Michael; Bacchetti, Peter; Laraia, Barbara A.; Hecht, Frederick M.; Daubenmier, Jennifer

2016-01-01

We evaluated changes in mindful eating as a potential mechanism underlying the effects of a mindfulness-based intervention for weight loss on eating of sweet foods and fasting glucose levels. We randomized 194 obese individuals (M age = 47.0 ± 12.7 years; BMI = 35.5 ± 3.6; 78 % women) to a 5.5-month diet-exercise program with or without mindfulness training. The mindfulness group, relative to the active control group, evidenced increases in mindful eating and maintenance of fasting glucose from baseline to 12-month assessment. Increases in mindful eating were associated with decreased eating of sweets and fasting glucose levels among mindfulness group participants, but this association was not statistically significant among active control group participants. Twelve-month increases in mindful eating partially mediated the effect of intervention arm on changes in fasting glucose levels from baseline to 12-month assessment. Increases in mindful eating may contribute to the effects of mindfulness-based weight loss interventions on eating of sweets and fasting glucose levels. PMID:26563148

Effects of a mindfulness-based intervention on mindful eating, sweets consumption, and fasting glucose levels in obese adults: data from the SHINE randomized controlled trial.

PubMed

Mason, Ashley E; Epel, Elissa S; Kristeller, Jean; Moran, Patricia J; Dallman, Mary; Lustig, Robert H; Acree, Michael; Bacchetti, Peter; Laraia, Barbara A; Hecht, Frederick M; Daubenmier, Jennifer

2016-04-01

We evaluated changes in mindful eating as a potential mechanism underlying the effects of a mindfulness-based intervention for weight loss on eating of sweet foods and fasting glucose levels. We randomized 194 obese individuals (M age = 47.0 ± 12.7 years; BMI = 35.5 ± 3.6; 78% women) to a 5.5-month diet-exercise program with or without mindfulness training. The mindfulness group, relative to the active control group, evidenced increases in mindful eating and maintenance of fasting glucose from baseline to 12-month assessment. Increases in mindful eating were associated with decreased eating of sweets and fasting glucose levels among mindfulness group participants, but this association was not statistically significant among active control group participants. Twelve-month increases in mindful eating partially mediated the effect of intervention arm on changes in fasting glucose levels from baseline to 12-month assessment. Increases in mindful eating may contribute to the effects of mindfulness-based weight loss interventions on eating of sweets and fasting glucose levels.

[Cost]effectiveness of withdrawal of fall-risk increasing drugs versus conservative treatment in older fallers: design of a multicenter randomized controlled trial (IMPROveFALL-study)

PubMed Central

2011-01-01

Background Fall incidents represent an increasing public health problem in aging societies worldwide. A major risk factor for falls is the use of fall-risk increasing drugs. The primary aim of the study is to compare the effect of a structured medication assessment including the withdrawal of fall-risk increasing drugs on the number of new falls versus 'care as usual' in older adults presenting at the Emergency Department after a fall. Methods/Design A prospective, multi-center, randomized controlled trial will be conducted in hospitals in the Netherlands. Persons aged ≥65 years who visit the Emergency Department due to a fall are invited to participate in this trial. All patients receive a full geriatric assessment at the research outpatient clinic. Patients are randomized between a structured medication assessment including withdrawal of fall-risk increasing drugs and 'care as usual'. A 3-monthly falls calendar is used for assessing the number of falls, fallers and associated injuries over a one-year follow-up period. Measurements will be at three, six, nine, and twelve months and include functional outcome, healthcare consumption, socio-demographic characteristics, and clinical information. After twelve months a second visit to the research outpatient clinic will be performed, and adherence to the new medication regimen in the intervention group will be measured. The primary outcome will be the incidence of new falls. Secondary outcome measurements are possible health effects of medication withdrawal, health-related quality of life (Short Form-12 and EuroQol-5D), costs, and cost-effectiveness of the intervention. Data will be analyzed using an intention-to-treat analysis. Discussion The successful completion of this trial will provide evidence on the effectiveness of withdrawal of fall-risk increasing drugs in older patients as a method for falls reduction. Trial Registration The trial is registered in the Netherlands Trial Register (NTR1593) PMID:21854643

Repetition-lag training to improve recollection memory in older people with amnestic mild cognitive impairment. A randomized controlled trial.

PubMed

Finn, Maurice; McDonald, Skye

2015-01-01

The results of a randomized controlled trial of repetition-lag training in older adults with amnestic mild cognitive impairment (aMCI) are reported. A modified repetition-lag training procedure with extended encoding time and strategy choice was used. The training required discriminating studied words from non-studied lures that were repeated at varying intervals during the test phase. Participants were assessed pre/post using untrained measures of cognition and self-report questionnaires. Primary outcome measures were recall of unrelated word pairs both immediately following presentation and following a delay. Secondary outcomes were a measure of attention, cognitive flexibility, and visual working memory. Participants were also asked to report on the frequency of cognitive failures and mood before and after training. Participants (N = 31) were randomized into either the treatment or a no-contact control group and attended the clinic twice per week over a four week period. Twenty-four participants completed the study (twelve in each group). Results indicated that the training group improved at recalling unrelated word pairs after a delay. There were no significant effects of training on other outcomes, self-reported cognitive failures or mood. The results are discussed along with suggestions for future research.

Preventing Childhood Bullying: Findings and Lessons from the Denver Public Schools Trial

ERIC Educational Resources Information Center

Jenson, Jeffrey M.; Dieterich, William A.; Brisson, Daniel; Bender, Kimberly A.; Powell, Anne

2010-01-01

Twelve-month follow-up outcomes from a group-randomized trial (GRT) of a classroom curriculum aimed at preventing bullying and victimization among elementary students in the Denver, Colorado, public school system are presented. Twenty-eight elementary schools were randomly assigned to receive selected modules of "Youth Matters" (YM), a…

Twelve Weeks of Plyometric Training Improves Motor Performance of 7- to 9-Year-Old Boys Who Were Overweight/Obese: A Randomized Controlled Intervention.

PubMed

Nobre, Gabriela G; de Almeida, Marcelus B; Nobre, Isabele G; Dos Santos, Fernanda K; Brinco, Raphael A; Arruda-Lima, Thalison R; de-Vasconcelos, Kenya L; de-Lima, Jociellen G; Borba-Neto, Manoel E; Damasceno-Rodrigues, Emmanuel M; Santos-Silva, Steve M; Leandro, Carol G; Moura-Dos-Santos, Marcos A

2017-08-01

Nobre, GG, de Almeida, MB, Nobre, IG, dos Santos, FK, Brinco, RA, Arruda-Lima, TR, de-Vasconcelos, KL, de-Lima, JG, Borba-Neto, ME, Damasceno-Rodrigues, EM, Santos-Silva, SM, Leandro, CG, and Moura-dos-Santos, MA. Twelve weeks of plyometric training improves motor performance of 7- to 9-year-old boys who were overweight/obese: a randomized controlled intervention. J Strength Cond Res 31(8): 2091-2099, 2017-The prevalence of childhood overweight/obesity has increased, and physical training at school may to be effective to combat this scenario. We analyzed the effects of a protocol of plyometric training on body composition and motor performance of boys who were overweight/obese aged 7-9 years. The sample was randomly assigned into 2 groups: plyometric training group (T, n = 40) and control group (C, n = 19). Training consisted of 20 min·d (twice a week, during 12 weeks) of lower extremity plyometric exercise. Health-related physical fitness was measured by handgrip strength, standing long jump (SLJ), curl-ups, sit and reach, square test, running speed, and mile run test. Gross motor coordination was evaluated by means of the Körperkoordinations-test für Kinder (KTK) tests. Baseline and postintervention differences were investigated, and effect size was estimated through Cohen's d coefficient. Both groups showed increased body weight, height, and sitting height after intervention with a negligible effect size. Only T group showed increased fat-free mass (p = 0.011) compared with baseline values with small effect size. Plyometric training improved handgrip strength (d = 0.23), sit and reach (d = 0.18), curl-ups (d = 0.39), SLJ (d = 0.80), agility (d = 0.48), and time in the mile run test (d = 0.38). For gross motor coordination results, T group showed better performance in all tests after plyometric training with moderate/large effect size. Thus, 12 weeks of PT improved health-related physical fitness components and motor coordination acquisition of 7- to 9-year-old boys who were overweight/obese.

Extracorporeal shock wave therapy without local anesthesia for chronic lateral epicondylitis.

PubMed

Pettrone, Frank A; McCall, Brian R

2005-06-01

The use of extracorporeal shock wave therapy for the treatment of lateral epicondylitis is controversial. The purpose of this study was to evaluate the use of extracorporeal shock wave therapy without local anesthesia to treat chronic lateral epicondylitis. One hundred and fourteen patients with a minimum six-month history of lateral epicondylitis that was unresponsive to conventional therapy were randomized into double-blind active treatment and placebo groups. The protocol consisted of three weekly treatments of either low-dose shock wave therapy without anesthetic or a sham treatment. Patients had a physical examination, including provocation testing and dynamometry, at one, four, eight, and twelve weeks and at six and twelve months after treatment. Radiographs, laboratory studies, and electrocardiograms were also evaluated prior to participation and at twelve weeks. A visual analog scale was used to evaluate pain, and an upper extremity functional scale was used to assess function. Crossover to active treatment was initiated for nonresponsive patients who had received the placebo and met the inclusion criteria after twelve weeks. A total of 108 of the 114 randomized patients completed all treatments and the twelve weeks of follow-up required by the protocol. Sixty-one patients completed one year of follow-up, whereas thirty-four patients crossed over to receive active treatment. A significant difference (p = 0.001) in pain reduction was observed at twelve weeks in the intent-to-treat cohort, with an improvement in the pain score of at least 50% seen in 61% (thirty-four) of the fifty-six patients in the active treatment group who were treated according to protocol compared with 29% (seventeen) of the fifty-eight subjects in the placebo group. This improvement persisted in those followed to one year. Functional activity scores, activity-specific evaluation, and the overall impression of the disease state all showed significant improvement as well (p < 0.05). Crossover patients also showed significant improvement after twelve weeks of active treatment, with 56% (nineteen of thirty-four) achieving an improvement in the pain score of at least 50% (p < 0.0001). These results demonstrate that low-dose shock wave therapy without anesthetic is a safe and effective treatment for chronic lateral epicondylitis.

Serious adverse events in randomized psychosocial treatment studies: Safety or Arbitrary Edicts?

PubMed Central

Petry, Nancy M.; Roll, John M.; Rounsaville, Bruce J.; Ball, Samuel A.; Stitzer, Maxine; Peirce, Jessica M.; Blaine, Jack; Kirby, Kimberly C.; McCarty, Dennis; Carroll, Kathleen M.

2009-01-01

Human subjects protection policies developed for pharmaceutical trials are now being widely applied to psychosocial intervention studies. This study examined occurrences of serious adverse events (SAEs) reported in multicenter psychosocial trials of the National Institute on Drug Abuse Clinical Trials Network. Substance abusing participants (N=1,687) were randomized to standard care or standard care plus either contingency management or motivational enhancement. Twelve percent of participants experienced one or more SAEs during the 27,198 person-weeks of follow-up. Of the 260 SAEs recorded, none were judged by the Data Safety Monitoring Board to be study related, and there were no significant differences between experimental and control conditions in SAE incidence rates. These data underscore the need to reconsider the rationale behind, and appropriate methods for, monitoring safety during psychosocial therapy trials. PMID:19045975

A randomized controlled evaluation of a secondary school mindfulness program for early adolescents: Do we have the recipe right yet?

PubMed

Johnson, Catherine; Burke, Christine; Brinkman, Sally; Wade, Tracey

2017-12-01

Mindfulness is being promoted in schools as a prevention program despite a current small evidence base. The aim of this research was to conduct a rigorous evaluation of the .b ("Dot be") mindfulness curriculum, with or without parental involvement, compared to a control condition. In a randomized controlled design, students (M age 13.44, SD 0.33; 45.4% female) across a broad range of socioeconomic indicators received the nine lesson curriculum delivered by an external facilitator with (N = 191) or without (N = 186) parental involvement, or were allocated to a usual curriculum control group (N = 178). Self-report outcome measures were anxiety, depression, weight/shape concerns, wellbeing and mindfulness. There were no differences in outcomes between any of the three groups at post-intervention, six or twelve month follow-up. Between-group effect sizes (Cohen's d) across the variables ranged from 0.002 to 0.37. A wide range of moderators were examined but none impacted outcome. Further research is required to identify the optimal age, content and length of mindfulness programs for adolescents in universal prevention settings. ACTRN12615001052527. Copyright © 2017 Elsevier Ltd. All rights reserved.

An Examination of Strategy Implementation During Abstract Nonlinguistic Category Learning in Aphasia.

PubMed

Vallila-Rohter, Sofia; Kiran, Swathi

2015-08-01

Our purpose was to study strategy use during nonlinguistic category learning in aphasia. Twelve control participants without aphasia and 53 participants with aphasia (PWA) completed a computerized feedback-based category learning task consisting of training and testing phases. Accuracy rates of categorization in testing phases were calculated. To evaluate strategy use, strategy analyses were conducted over training and testing phases. Participant data were compared with model data that simulated complex multi-cue, single feature, and random pattern strategies. Learning success and strategy use were evaluated within the context of standardized cognitive-linguistic assessments. Categorization accuracy was higher among control participants than among PWA. The majority of control participants implemented suboptimal or optimal multi-cue and single-feature strategies by testing phases of the experiment. In contrast, a large subgroup of PWA implemented random patterns, or no strategy, during both training and testing phases of the experiment. Person-to-person variability arises not only in category learning ability but also in the strategies implemented to complete category learning tasks. PWA less frequently developed effective strategies during category learning tasks than control participants. Certain PWA may have impairments of strategy development or feedback processing not captured by language and currently probed cognitive abilities.

A cluster randomized trial of routine HIV-1 viral load monitoring in Zambia: study design, implementation, and baseline cohort characteristics.

PubMed

Koethe, John R; Westfall, Andrew O; Luhanga, Dora K; Clark, Gina M; Goldman, Jason D; Mulenga, Priscilla L; Cantrell, Ronald A; Chi, Benjamin H; Zulu, Isaac; Saag, Michael S; Stringer, Jeffrey S A

2010-03-12

The benefit of routine HIV-1 viral load (VL) monitoring of patients on antiretroviral therapy (ART) in resource-constrained settings is uncertain because of the high costs associated with the test and the limited treatment options. We designed a cluster randomized controlled trial to compare the use of routine VL testing at ART-initiation and at 3, 6, 12, and 18 months, versus our local standard of care (which uses immunological and clinical criteria to diagnose treatment failure, with discretionary VL testing when the two do not agree). Dedicated study personnel were integrated into public-sector ART clinics. We collected participant information in a dedicated research database. Twelve ART clinics in Lusaka, Zambia constituted the units of randomization. Study clinics were stratified into pairs according to matching criteria (historical mortality rate, size, and duration of operation) to limit the effect of clustering, and independently randomized to the intervention and control arms. The study was powered to detect a 36% reduction in mortality at 18 months. From December 2006 to May 2008, we completed enrollment of 1973 participants. Measured baseline characteristics did not differ significantly between the study arms. Enrollment was staggered by clinic pair and truncated at two matched sites. A large clinical trial of routing VL monitoring was successfully implemented in a dynamic and rapidly growing national ART program. Close collaboration with local health authorities and adequate reserve staff were critical to success. Randomized controlled trials such as this will likely prove valuable in determining long-term outcomes in resource-constrained settings. Clinicaltrials.gov NCT00929604.

An Economic Evaluation of a Video- and Text-Based Computer-Tailored Intervention for Smoking Cessation: A Cost-Effectiveness and Cost-Utility Analysis of a Randomized Controlled Trial

PubMed Central

Stanczyk, Nicola E.; Smit, Eline S.; Schulz, Daniela N.; de Vries, Hein; Bolman, Catherine; Muris, Jean W. M.; Evers, Silvia M. A. A.

2014-01-01

Background Although evidence exists for the effectiveness of web-based smoking cessation interventions, information about the cost-effectiveness of these interventions is limited. Objective The study investigated the cost-effectiveness and cost-utility of two web-based computer-tailored (CT) smoking cessation interventions (video- vs. text-based CT) compared to a control condition that received general text-based advice. Methods In a randomized controlled trial, respondents were allocated to the video-based condition (N = 670), the text-based condition (N = 708) or the control condition (N = 721). Societal costs, smoking status, and quality-adjusted life years (QALYs; EQ-5D-3L) were assessed at baseline, six-and twelve-month follow-up. The incremental costs per abstinent respondent and per QALYs gained were calculated. To account for uncertainty, bootstrapping techniques and sensitivity analyses were carried out. Results No significant differences were found in the three conditions regarding demographics, baseline values of outcomes and societal costs over the three months prior to baseline. Analyses using prolonged abstinence as outcome measure indicated that from a willingness to pay of €1,500, the video-based intervention was likely to be the most cost-effective treatment, whereas from a willingness to pay of €50,400, the text-based intervention was likely to be the most cost-effective. With regard to cost-utilities, when quality of life was used as outcome measure, the control condition had the highest probability of being the most preferable treatment. Sensitivity analyses yielded comparable results. Conclusion The video-based CT smoking cessation intervention was the most cost-effective treatment for smoking abstinence after twelve months, varying the willingness to pay per abstinent respondent from €0 up to €80,000. With regard to cost-utility, the control condition seemed to be the most preferable treatment. Probably, more time will be required to assess changes in quality of life. Future studies with longer follow-up periods are needed to investigate whether cost-utility results regarding quality of life may change in the long run. Trial Registration Nederlands Trial Register NTR3102 PMID:25310007

An economic evaluation of a video- and text-based computer-tailored intervention for smoking cessation: a cost-effectiveness and cost-utility analysis of a randomized controlled trial.

PubMed

Stanczyk, Nicola E; Smit, Eline S; Schulz, Daniela N; de Vries, Hein; Bolman, Catherine; Muris, Jean W M; Evers, Silvia M A A

2014-01-01

Although evidence exists for the effectiveness of web-based smoking cessation interventions, information about the cost-effectiveness of these interventions is limited. The study investigated the cost-effectiveness and cost-utility of two web-based computer-tailored (CT) smoking cessation interventions (video- vs. text-based CT) compared to a control condition that received general text-based advice. In a randomized controlled trial, respondents were allocated to the video-based condition (N = 670), the text-based condition (N = 708) or the control condition (N = 721). Societal costs, smoking status, and quality-adjusted life years (QALYs; EQ-5D-3L) were assessed at baseline, six-and twelve-month follow-up. The incremental costs per abstinent respondent and per QALYs gained were calculated. To account for uncertainty, bootstrapping techniques and sensitivity analyses were carried out. No significant differences were found in the three conditions regarding demographics, baseline values of outcomes and societal costs over the three months prior to baseline. Analyses using prolonged abstinence as outcome measure indicated that from a willingness to pay of €1,500, the video-based intervention was likely to be the most cost-effective treatment, whereas from a willingness to pay of €50,400, the text-based intervention was likely to be the most cost-effective. With regard to cost-utilities, when quality of life was used as outcome measure, the control condition had the highest probability of being the most preferable treatment. Sensitivity analyses yielded comparable results. The video-based CT smoking cessation intervention was the most cost-effective treatment for smoking abstinence after twelve months, varying the willingness to pay per abstinent respondent from €0 up to €80,000. With regard to cost-utility, the control condition seemed to be the most preferable treatment. Probably, more time will be required to assess changes in quality of life. Future studies with longer follow-up periods are needed to investigate whether cost-utility results regarding quality of life may change in the long run. Nederlands Trial Register NTR3102.

Universal Internet-based prevention for alcohol and cannabis use reduces truancy, psychological distress and moral disengagement: a cluster randomised controlled trial.

PubMed

Newton, Nicola C; Andrews, Gavin; Champion, Katrina E; Teesson, Maree

2014-08-01

A universal Internet-based preventive intervention has been shown to reduce alcohol and cannabis use. The aim of this study was to examine if this program could also reduce risk-factors associated with substance use in adolescents. A cluster randomised controlled trial was conducted in Sydney, Australia in 2007-2008 to assess the effectiveness of the Internet-based Climate Schools: Alcohol and Cannabis course. The evidence-based course, aimed at reducing alcohol and cannabis use, consists of two sets of six lessons delivered approximately six months apart. A total of 764 students (mean 13.1years) from 10 secondary schools were randomly allocated to receive the preventive intervention (n=397, five schools), or their usual health classes (n=367, five schools) over the year. Participants were assessed at baseline, immediately post, and six and twelve months following the intervention on their levels of truancy, psychological distress and moral disengagement. Compared to the control group, students in the intervention group showed significant reductions in truancy, psychological distress and moral disengagement up to twelve months following completion of the intervention. These intervention effects indicate that Internet-based preventive interventions designed to prevent alcohol and cannabis use can concurrently reduce risk-factors associated with substance use in adolescents. Australian Clinical Trials Registry ACTRN: 012607000312448. Copyright © 2014 Elsevier Inc. All rights reserved.

Low-dose rectal diclofenac for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a randomized controlled trial.

PubMed

Otsuka, Taiga; Kawazoe, Seiji; Nakashita, Shunya; Kamachi, Saori; Oeda, Satoshi; Sumida, Chinatsu; Akiyama, Takumi; Ario, Keisuke; Fujimoto, Masaru; Tabuchi, Masanobu; Noda, Takahiro

2012-08-01

Acute pancreatitis is a common complication of endoscopic retrograde cholangiopancreatography (ERCP). Rectal nonsteroidal anti-inflammatory drugs (specifically, 100 mg of diclofenac or indomethacin) have shown promising prophylactic activity in post-ERCP pancreatitis (PEP). However, the 100-mg dose is higher than that ordinarily used in Japan. We performed a prospective randomized controlled study to evaluate the efficacy of low-dose rectal diclofenac for the prevention of PEP. Patients who were scheduled to undergo ERCP were randomized to receive a saline infusion either with 50 mg of rectal diclofenac (diclofenac group) or without (control group) 30 min before ERCP. The dose of diclofenac was reduced to 25 mg in patients weighing <50 kg. The primary outcome measure was the occurrence of PEP. Enrollment was terminated early because the planned interim analysis found a statistically significant intergroup difference in the occurrence of PEP. A total of 104 patients were eligible for this study; 51 patients received rectal diclofenac. Twelve patients (11.5%) developed PEP: 3.9% (2/51) in the diclofenac group and 18.9% (10/53) in the control group (p = 0.017). After ERCP, the incidence of hyperamylasemia was not significantly different between the two groups. Post-ERCP pain was significantly more frequent in the control group than in the diclofenac group (37.7 vs. 7.8%, respectively; p < 0.001). There were no adverse events related to diclofenac. Low-dose rectal diclofenac can prevent PEP.

Effect of body-weight suspension training versus treadmill training on gross motor abilities of children with spastic diplegic cerebral palsy.

PubMed

Emara, Hatem A; El-Gohary, Tarek M; Al-Johany, Ahmed A

2016-06-01

Suspension training and treadmill training are commonly used for promoting functional gross motor skills in children with cerebral palsy. The aim of this study was to compare the effect of body-weight suspension training versus treadmill training on gross motor functional skills. Assessor-blinded, randomized, controlled intervention study. Outpatient rehabilitation facility. Twenty children with spastic diplegia (7 boys and 13 girls) in the age ranged from 6 to 8 years old were randomly allocated into two equal groups. All children were assessed at baseline, after 18-session and after 36-session. During the twelve-week outpatient rehabilitation program, both groups received traditional therapeutic exercises. Additionally, one group received locomotor training using the treadmill while the other group received locomotor training using body-weight suspension through the dynamic spider cage. Assessment included dimensions "D" standing and "E" walking of the gross motor function measure, in addition to the 10-m Walking Test and the five times sit to stand test. Training was applied three times per week for twelve consecutive weeks. No significant difference was found in standing or walking ability for measurements taken at baseline or after 18-session of therapy. Measurements taken at 36-session showed that suspension training achieved significantly (P<0.05) higher average score than treadmill training for dimension D as well as for dimension E. No significant difference was found between suspension training and treadmill training regarding walking speed or sit to stand transitional skills. Body-weight suspension training is effective in improving walking and locomotor capabilities in children with spastic diplegia. After three month suspension training was superior to treadmill training. Body-weight suspension training promotes adequate postural stability, good balance control, and less exertion which facilitates efficient and safe gait.

12-Month Results From the First-in-Human Randomized Study of the Ranger Paclitaxel-Coated Balloon for Femoropopliteal Treatment.

PubMed

Steiner, Sabine; Willfort-Ehringer, Andrea; Sievert, Horst; Geist, Volker; Lichtenberg, Michael; Del Giudice, Costantino; Sauguet, Antoine; Diaz-Cartelle, Juan; Marx, Claudia; Ströbel, Armin; Schult, Ingolf; Scheinert, Dierk

2018-05-28

The authors sought to evaluate the performance of the Ranger paclitaxel-coated balloon versus uncoated balloon angioplasty for femoropopliteal lesions at 12 months. Drug-coated balloons (DCBs) are a promising endovascular treatment option for peripheral artery disease of the femoropopliteal segment, and each unique device requires dedicated clinical study. The prospective, randomized RANGER SFA (Comparison of the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and Uncoated PTA Balloons in Femoropopliteal Arteries) study (NCT02013193) enrolled 105 patients with symptomatic lower limb ischemia (Rutherford category 2 to 4) and stenotic lesions in the nonstented femoropopliteal segment at 10 European centers. Seventy-one patients (mean age 68 ± 8 years, n = 53 men) were enrolled in the Ranger DCB arm, and 34 patients (mean age 67 ± 9 years, n = 23 men) were assigned to the control group. Twelve-month analysis included patency, safety, and clinical outcomes and quality-of-life assessments. The DCB group had a greater primary patency rate at 12 months (Kaplan-Meier estimate 86.4% vs. 56.5%), with a significantly longer time to patency failure (log-rank p < 0.001). The estimated freedom from target lesion revascularization rate was 91.2% in the DCB group and 69.9% in the control group at 12 months, with a significantly longer time to reintervention (p = 0.010). No target limb amputations or device-related deaths occurred in either group. Twelve-month results show that patency was maintained longer after Ranger DCB treatment than after conventional balloon angioplasty, and this result was associated with a low revascularization rate and good clinical outcomes. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Long-term outcomes and predictors of internet-delivered cognitive behavioral therapy for childhood anxiety disorders.

PubMed

Vigerland, Sarah; Serlachius, Eva; Thulin, Ulrika; Andersson, Gerhard; Larsson, Jan-Olov; Ljótsson, Brjánn

2017-03-01

This study investigated the long-term outcomes of internet-delivered cognitive behavior therapy (ICBT) for children with anxiety disorders, and potential pre-treatment predictors of treatment outcome. The sample included eighty-four children (8-12 years old) with anxiety disorders, from both a treatment group and a waitlist control (after participants had crossed over to treatment) of a previous randomized controlled study. Participants were assessed at post-treatment and three- and twelve-months after treatment using a semi-structured interview and parent ratings. Pre-treatment data were used to investigate predictors of treatment outcome at three-month follow-up. Intention-to-treat analysis showed that treatment gains were maintained at twelve-month follow-up, including clinician rated severity of the principal anxiety disorder, parent rated anxiety symptoms and global functioning, with mainly large effect sizes (Cohen's d = 0.63-2.35). Completer analyses showed that suspected autism spectrum disorder was associated with less change in symptom severity. No other pre-treatment measures significantly predicted treatment outcome. This study suggests that internet-delivered CBT can have long-term beneficial effects for children with anxiety disorders. Predictors of treatment outcome need to be evaluated further. Clinicaltrials.gov; NCT01533402. Copyright © 2016 Elsevier Ltd. All rights reserved.

High-cocoa polyphenol-rich chocolate improves HDL cholesterol in Type 2 diabetes patients.

PubMed

Mellor, D D; Sathyapalan, T; Kilpatrick, E S; Beckett, S; Atkin, S L

2010-11-01

To examine the effects of chocolate on lipid profiles, weight and glycaemic control in individuals with Type 2 diabetes. Twelve individuals with Type 2 diabetes on stable medication were enrolled in a randomized, placebo-controlled double-blind crossover study. Subjects were randomized to 45 g chocolate with or without a high polyphenol content for 8 weeks and then crossed over after a 4-week washout period. Changes in weight, glycaemic control, lipid profile and high-sensitivity C-reactive protein were measured at the beginning and at the end of each intervention. HDL cholesterol increased significantly with high polyphenol chocolate (1.16 ± 0.08 vs. 1.26 ± 0.08 mmol/l, P = 0.05) with a decrease in the total cholesterol: HDL ratio (4.4 ± 0.4 vs. 4.1 ± 0.4 mmol/l, P = 0.04). No changes were seen with the low polyphenol chocolate in any parameters. Over the course of 16 weeks of daily chocolate consumption neither weight nor glycaemic control altered from baseline. High polyphenol chocolate is effective in improving the atherosclerotic cholesterol profile in patients with diabetes by increasing HDL cholesterol and improving the cholesterol:HDL ratio without affecting weight, inflammatory markers, insulin resistance or glycaemic control.

A randomized, double-blind, split-face study comparing the efficacy and tolerability of three retinol-based products vs. three tretinoin-based products in subjects with moderate to severe facial photodamage.

PubMed

Babcock, Michael; Mehta, Rahul C; Makino, Elizabeth T

2015-01-01

Retinol, has been shown to improve the appearance of photodamaged skin when applied topically, and is generally considered to be approximately ten times less potent than tretinoin. To assess this theory, three cosmetic formulations containing 0.25%, 0.5%, and 1.0% retinol were developed to correspond to the three commonly prescribed concentrations of tretinoin (0.025%, 0.05%, and 0.1%). A randomized, double-blind, split-face comparison study was conducted to compare the three concentrations retinol (Ret) including 0.25%, 0.5%, and 1.0%, against the respective three strengths of tretinoin (Tret) 0.025%, 0.05%, and 0.1% in subjects with moderate to severe facial photodamage. Subjects were randomized into three groups: Group 1 (Ret 0.25% vs. Tret 0.025%); Group 2 (Ret 0.5% vs. Tret 0.05%); and Group 3 (Ret 1.0% vs. Tret 0.1%). Within each group, subjects were randomized to apply Ret on one half of the face (left or right) and Tret on the other facial side, for a duration of twelve weeks. Clinical evaluations for efficacy and tolerability, as well as standardized digital photographs were conducted at baseline and at weeks 4, 8, and 12. Sixty-five subjects completed the twelve-week study (Group 1: n=24, Group 2: n=20, and Group 3: n=21). At week 12 in all treatment groups, both Ret and Tret produced statistically significant improvements from baseline in all efficacy parameters, including overall photodamage, fine lines/wrinkles, coarse lines/wrinkles, skin tone brightness, mottled pigmentation, and tactile roughness (all P<0.001). There were no significant differences in efficacy between Ret and Tret in these efficacy parameters. Results from this comparison study suggest that this sustained-release retinol complex containing multiple agents for optimal irritation control provides comparable improvements to tretinoin in the appearance of photodamage.

Twelve Months of Nightly Zolpidem Does Not Lead to Dose Escalation: A Prospective Placebo-Controlled Study

PubMed Central

Roehrs, Timothy A.; Randall, Surilla; Harris, Erica; Maan, Renee; Roth, Thomas

2011-01-01

Study Objectives: To assess hypnotic self-administration and likelihood of dose escalation over 12 months of nightly use of zolpidem versus placebo in primary insomniacs. Design: Randomized, double-blind, placebo-controlled, clinical trial. Setting: Outpatient with tri-monthly one-week, sleep laboratory assessments. Participants: Thirty-three primary insomniacs, without psychiatric disorders or drug and alcohol abuse, 32–64 yrs old, 14 men and 19 women. Interventions: Participants were randomized to take zolpidem 10 mg (n = 17) or placebo (n = 16) nightly for 12 months. In probes during month 1, 4, and 12, after sampling color-coded placebo or zolpidem capsules on 2 nights, color-coded zolpidem or placebo was chosen on 5 consecutive nights and 1, 2, or 3 of the chosen capsules (5 mg each) could be self-administered on a given choice night. Results: Zolpidem was chosen more nights than placebo (80% of nights) and number of nights zolpidem was chosen did not differ over the 12 months. More zolpidem than placebo capsules were self-administered, and the total number of placebo or zolpidem capsules self-administered did not differ as a function of duration of use. In contrast, the total number of placebo capsules self-administered by the placebo group increased across time. The nightly capsule self-administration on zolpidem nights did not differ from that on placebo nights and neither nightly self-administration rates increased over the 12 months. An average 9.3 mg nightly dose was self-administered. Conclusions: Zolpidem was preferred to placebo, but its self-administration did not increase with 12 months of use. Chronic hypnotic use by primary insomniacs does not lead to dose escalation. Clinical Trial Registration: Safety and Efficacy of Chronic Hypnotic Use; # NCT01006525; http://www.clinicaltrials.gov/ Citation: Roehrs TA; Randall S; Harris E; Maan R; Roth T. Twelve months of nightly zolpidem does not lead to dose escalation: a prospective placebo-controlled study. SLEEP 2011;34(2):207–212. PMID:21286241

Consumption of Dairy Yogurt Containing Lactobacillus paracasei ssp. paracasei, Bifidobacterium animalis ssp. lactis and Heat-Treated Lactobacillus plantarum Improves Immune Function Including Natural Killer Cell Activity.

PubMed

Lee, Ayoung; Lee, Young Ju; Yoo, Hye Jin; Kim, Minkyung; Chang, Yeeun; Lee, Dong Seog; Lee, Jong Ho

2017-05-31

The aim of this study was to investigate the impact of consuming dairy yogurt containing Lactobacillus paracasei ssp. paracasei ( L. paracasei ), Bifidobacterium animalis ssp. lactis ( B. lactis ) and heat-treated Lactobacillus plantarum ( L. plantarum ) on immune function. A randomized, open-label, placebo-controlled study was conducted on 200 nondiabetic subjects. Over a twelve-week period, the test group consumed dairy yogurt containing probiotics each day, whereas the placebo group consumed milk. Natural killer (NK) cell activity, interleukin (IL)-12 and immunoglobulin (Ig) G1 levels were significantly increased in the test group at twelve weeks compared to baseline. Additionally, the test group had significantly greater increases in serum NK cell activity and interferon (IFN)-γ and IgG1 than placebo group. Daily consumption of dairy yogurt containing L. paracasei , B. lactis and heat-treated L. plantarum could be an effective option to improve immune function by enhancing NK cell function and IFN-γ concentration (ClinicalTrials.gov: NCT03051425).

Consumption of Dairy Yogurt Containing Lactobacillus paracasei ssp. paracasei, Bifidobacterium animalis ssp. lactis and Heat-Treated Lactobacillus plantarum Improves Immune Function Including Natural Killer Cell Activity

PubMed Central

Lee, Ayoung; Lee, Young Ju; Yoo, Hye Jin; Kim, Minkyung; Chang, Yeeun; Lee, Dong Seog; Lee, Jong Ho

2017-01-01

The aim of this study was to investigate the impact of consuming dairy yogurt containing Lactobacillus paracasei ssp. paracasei (L. paracasei), Bifidobacterium animalis ssp. lactis (B. lactis) and heat-treated Lactobacillus plantarum (L. plantarum) on immune function. A randomized, open-label, placebo-controlled study was conducted on 200 nondiabetic subjects. Over a twelve-week period, the test group consumed dairy yogurt containing probiotics each day, whereas the placebo group consumed milk. Natural killer (NK) cell activity, interleukin (IL)-12 and immunoglobulin (Ig) G1 levels were significantly increased in the test group at twelve weeks compared to baseline. Additionally, the test group had significantly greater increases in serum NK cell activity and interferon (IFN)-γ and IgG1 than placebo group. Daily consumption of dairy yogurt containing L. paracasei, B. lactis and heat-treated L. plantarum could be an effective option to improve immune function by enhancing NK cell function and IFN-γ concentration (ClinicalTrials.gov: NCT03051425). PMID:28561762

Twelve weeks of BodyBalance® training improved balance and functional task performance in middle-aged and older adults

PubMed Central

Nicholson, Vaughan P; McKean, Mark R; Burkett, Brendan J

2014-01-01

Purpose The purpose of the study was to evaluate the effect of BodyBalance® training on balance, functional task performance, fear of falling, and health-related quality of life in adults aged over 55 years. Participants and methods A total of 28 healthy, active adults aged 66±5 years completed the randomized controlled trial. Balance, functional task performance, fear of falling, and self-reported quality of life were assessed at baseline and after 12 weeks. Participants either undertook two sessions of BodyBalance per week for 12 weeks (n=15) or continued with their normal activities (n=13). Results Significant group-by-time interactions were found for the timed up and go (P=0.038), 30-second chair stand (P=0.037), and mediolateral center-of-pressure range in narrow stance with eyes closed (P=0.017). There were no significant effects on fear of falling or self-reported quality of life. Conclusion Twelve weeks of BodyBalance training is effective at improving certain balance and functional based tasks in healthy older adults. PMID:25395844

Effect of village-wide use of long-lasting insecticidal nets on visceral Leishmaniasis vectors in India and Nepal: a cluster randomized trial.

PubMed

Picado, Albert; Das, Murari L; Kumar, Vijay; Kesari, Shreekant; Dinesh, Diwakar S; Roy, Lalita; Rijal, Suman; Das, Pradeep; Rowland, Mark; Sundar, Shyam; Coosemans, Marc; Boelaert, Marleen; Davies, Clive R

2010-01-26

Visceral leishmaniasis (VL) control in the Indian subcontinent is currently based on case detection and treatment, and on vector control using indoor residual spraying (IRS). The use of long-lasting insecticidal nets (LN) has been postulated as an alternative or complement to IRS. Here we tested the impact of comprehensive distribution of LN on the density of Phlebotomus argentipes in VL-endemic villages. A cluster-randomized controlled trial with household P. argentipes density as outcome was designed. Twelve clusters from an ongoing LN clinical trial--three intervention and three control clusters in both India and Nepal--were selected on the basis of accessibility and VL incidence. Ten houses per cluster selected on the basis of high pre-intervention P. argentipes density were monitored monthly for 12 months after distribution of LN using CDC light traps (LT) and mouth aspiration methods. Ten cattle sheds per cluster were also monitored by aspiration. A random effect linear regression model showed that the cluster-wide distribution of LNs significantly reduced the P. argentipes density/house by 24.9% (95% CI 1.80%-42.5%) as measured by means of LTs. The ongoing clinical trial, designed to measure the impact of LNs on VL incidence, will confirm whether LNs should be adopted as a control strategy in the regional VL elimination programs. The entomological evidence described here provides some evidence that LNs could be usefully deployed as part of the VL control program. ClinicalTrials.gov CT-2005-015374.

Home-based exercise program and fall-risk reduction in older adults with multiple sclerosis: phase 1 randomized controlled trial.

PubMed

Sosnoff, Jacob J; Finlayson, Marcia; McAuley, Edward; Morrison, Steve; Motl, Robert W

2014-03-01

To determine the feasibility, safety, and efficacy of a home-based exercise intervention targeting fall risk in older adults with multiple sclerosis. A randomized controlled pilot trial. A home-based exercise program. Participants were randomly allocated to either a home-based exercise intervention group (n = 13) or a waiting list control group (n = 14). The exercise group completed exercises targeting lower muscle strength and balance three times a week for 12 weeks. The control group continued normal activity. Fall risk (Physiological Profile Assessment scores), balance (Berg Balance Scale), and walking testing prior to and immediately following the 12-week intervention. Each outcome measure was placed in an analysis of covariance with group as the between-subject factor and baseline values as the covariate. Effect sizes were calculated. Twelve participants from the control group and ten from the exercise group completed the study. There were no related adverse events. Fall risk was found to decrease in the exercise group following the intervention (1.1 SD 1.0 vs. 0.6 SD 0.6) while there was an increase in fall risk in the control group (1.9 SD 1.5 vs. 2.2 SD 1.9). Effect sizes for most outcomes were large (η(2) > 0.15). Home-based exercise was found to be feasible, safe, and effective for reducing physiological fall risk in older adults with multiple sclerosis. Our findings support the implementation of a larger trial to reduce fall risk in persons with multiple sclerosis.

The effects of educating mothers and girls on the girls' attitudes toward puberty health: a randomized controlled trial.

PubMed

Afsari, Atousa; Mirghafourvand, Mojgan; Valizadeh, Sousan; Abbasnezhadeh, Massomeh; Galshi, Mina; Fatahi, Samira

2017-04-01

The attitude of a girl toward her menstruation and puberty has a considerable impact on her role during motherhood, social adjustment, and future marital life. This study was conducted in 2014 with the aim of comparing the effects of educating mothers and girls on the attitudes of adolescent girls of Tabriz City, Iran, towards puberty health. This randomized control clinical trial was conducted on 364 adolescent girls who experienced menstruation. Twelve schools were selected randomly among 107 secondary schools for girls. One-third of the students of each school were selected randomly using a table of random numbers and socio-demographic and each participant was asked to answer the attitude questionnaires. The schools were randomly allocated to the groups of mother's education, girl's education, and no-intervention. The attitude questionnaire was filled out by the participants again 2 months after intervention. The general linear model, in which the baseline values were controlled, was employed to compare the scores of the three groups after the intervention. No significant differences were observed among the three groups in terms of the attitude score before intervention (p>0.05). Attitude score improvement after intervention in the girl's education group was significantly higher than the one of both mother's education (adjusted mean difference [AMD]: 1.8; [95% confidence interval (CI): 0.4-1.3]) and no-intervention groups (AMD: 1.3; [95% CI: 0.0-2.6]) by controlling the attitude score before intervention. Based on the findings, it is more effective to educate girls directly about puberty health to improve adolescent girls' attitudes than educating mothers and asking them to transfer information to the girls. Nevertheless, studies with longer training period and follow-up are proposed to determine the effects of educating girls (through their mothers) on their attitudes about puberty health.

Wenxin Keli versus Sotalol for Paroxysmal Atrial Fibrillation Caused by Hyperthyroidism: A Prospective, Open Label, and Randomized Study

PubMed Central

Meng, Zhaowei; Tan, Jian; He, Qing; Zhu, Mei; Li, Xue; Zhang, Jianping; Jia, Qiang; Wang, Shen; Zhang, Guizhi; Zheng, Wei

2015-01-01

We aimed to compare effectiveness of Wenxin Keli (WK) and sotalol in assisting sinus rhythm (SR) restoration from paroxysmal atrial fibrillation (PAF) caused by hyperthyroidism, as well as in maintaining SR. We randomly prescribed WK (18 g tid) or sotalol (80 mg bid) to 91 or 89 patients. Since it was not ethical not to give patients antiarrhythmia drugs, no control group was set. Antithyroid drugs were given to 90 patients (45 in WK group, 45 in sotalol group); 131I was given to 90 patients (46 in WK group, 44 in sotalol group). Three months later, SR was obtained in 83/91 or 80/89 cases from WK or sotalol groups (P = 0.762). By another analysis, SR was obtained in 86/90 or 77/90 cases from 131I or ATD groups (P = 0.022). Then, we randomly assigned the successfully SR-reverted patients into three groups: WK, sotalol, and control (no antiarrhythmia drug was given) groups. After twelve-month follow-up, PAF recurrence happened in 1/54, 2/54, and 9/55 cases, respectively. Log-Rank test showed significant higher PAF recurrent rate in control patients than either treatment (P = 0.06). We demonstrated the same efficacies of WK and sotalol to assist SR reversion from hyperthyroidism-caused PAF. We also showed that either drug could maintain SR in such patients. PMID:26074982

Online attentional bias modification training targeting anxiety and depression in unselected adolescents: Short- and long-term effects of a randomized controlled trial.

PubMed

de Voogd, E L; Wiers, R W; Prins, P J M; de Jong, P J; Boendermaker, W J; Zwitser, R J; Salemink, E

2016-12-01

Based on information processing models of anxiety and depression, we investigated the efficacy of multiple sessions of online attentional bias modification training to reduce attentional bias and symptoms of anxiety and depression, and to increase emotional resilience in youth. Unselected adolescents (N = 340, age: 11-18 years) were randomly allocated to eight sessions of a dot-probe, or a visual search-based attentional training, or one of two corresponding placebo control conditions. Cognitive and emotional measures were assessed pre- and post-training; emotional outcome measures also at three, six and twelve months follow-up. Only visual search training enhanced attention for positive information, and this effect was stronger for participants who completed more training sessions. Symptoms of anxiety and depression reduced, whereas emotional resilience improved. However, these effects were not especially pronounced in the active conditions. Thus, this large-scale randomized controlled study provided no support for the efficacy of the current online attentional bias modification training as a preventive intervention to reduce symptoms of anxiety or depression or to increase emotional resilience in unselected adolescents. However, the absence of biased attention related to symptomatology at baseline, and the large drop-out rates at follow-up preclude strong conclusions. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Effect of Map-vaccination in ewes on body condition score, weight and Map-shedding.

PubMed

Hüttner, Klim; Krämer, Ulla; Kleist, Petra

2012-01-01

Vaccination against Mycobacterium avium subspecies paratuberculosis (Map) in sheep receives growing attention worldwide, particularly in countries with national Map control strategies. A field study was conducted, investigating the effect of GUDAIR on body condition, weight and Map-shedding in a professionally managed but largely Map-affected suffolk flock prior and after vaccination. For this, 80 ewes out of 1000 animals were randomly sampled. In the univariate analysis body condition scores of ewes twelve months after vaccination improved significantly compared to those sampled prior to vaccination. At the same time the rate of ewes shedding Map was reduced by 37%.

Effect of tree nuts on glycemic control in diabetes: a systematic review and meta-analysis of randomized controlled dietary trials.

PubMed

Viguiliouk, Effie; Kendall, Cyril W C; Blanco Mejia, Sonia; Cozma, Adrian I; Ha, Vanessa; Mirrahimi, Arash; Jayalath, Viranda H; Augustin, Livia S A; Chiavaroli, Laura; Leiter, Lawrence A; de Souza, Russell J; Jenkins, David J A; Sievenpiper, John L

2014-01-01

Tree nut consumption has been associated with reduced diabetes risk, however, results from randomized trials on glycemic control have been inconsistent. To provide better evidence for diabetes guidelines development, we conducted a systematic review and meta-analysis of randomized controlled trials to assess the effects of tree nuts on markers of glycemic control in individuals with diabetes. MEDLINE, EMBASE, CINAHL, and Cochrane databases through 6 April 2014. Randomized controlled trials ≥3 weeks conducted in individuals with diabetes that compare the effect of diets emphasizing tree nuts to isocaloric diets without tree nuts on HbA1c, fasting glucose, fasting insulin, and HOMA-IR. Two independent reviewer's extracted relevant data and assessed study quality and risk of bias. Data were pooled by the generic inverse variance method and expressed as mean differences (MD) with 95% CI's. Heterogeneity was assessed (Cochran Q-statistic) and quantified (I2). Twelve trials (n = 450) were included. Diets emphasizing tree nuts at a median dose of 56 g/d significantly lowered HbA1c (MD = -0.07% [95% CI:-0.10, -0.03%]; P = 0.0003) and fasting glucose (MD = -0.15 mmol/L [95% CI: -0.27, -0.02 mmol/L]; P = 0.03) compared with control diets. No significant treatment effects were observed for fasting insulin and HOMA-IR, however the direction of effect favoured tree nuts. Majority of trials were of short duration and poor quality. Pooled analyses show that tree nuts improve glycemic control in individuals with type 2 diabetes, supporting their inclusion in a healthy diet. Owing to the uncertainties in our analyses there is a need for longer, higher quality trials with a focus on using nuts to displace high-glycemic index carbohydrates. ClinicalTrials.gov NCT01630980.

Effect of Tree Nuts on Glycemic Control in Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Dietary Trials

PubMed Central

Viguiliouk, Effie; Kendall, Cyril W. C.; Blanco Mejia, Sonia; Cozma, Adrian I.; Ha, Vanessa; Mirrahimi, Arash; Jayalath, Viranda H.; Augustin, Livia S. A.; Chiavaroli, Laura; Leiter, Lawrence A.; de Souza, Russell J.; Jenkins, David J. A.; Sievenpiper, John L.

2014-01-01

Background Tree nut consumption has been associated with reduced diabetes risk, however, results from randomized trials on glycemic control have been inconsistent. Objective To provide better evidence for diabetes guidelines development, we conducted a systematic review and meta-analysis of randomized controlled trials to assess the effects of tree nuts on markers of glycemic control in individuals with diabetes. Data Sources MEDLINE, EMBASE, CINAHL, and Cochrane databases through 6 April 2014. Study Selection Randomized controlled trials ≥3 weeks conducted in individuals with diabetes that compare the effect of diets emphasizing tree nuts to isocaloric diets without tree nuts on HbA1c, fasting glucose, fasting insulin, and HOMA-IR. Data Extraction and Synthesis Two independent reviewer’s extracted relevant data and assessed study quality and risk of bias. Data were pooled by the generic inverse variance method and expressed as mean differences (MD) with 95% CI’s. Heterogeneity was assessed (Cochran Q-statistic) and quantified (I2). Results Twelve trials (n = 450) were included. Diets emphasizing tree nuts at a median dose of 56 g/d significantly lowered HbA1c (MD = −0.07% [95% CI:−0.10, −0.03%]; P = 0.0003) and fasting glucose (MD = −0.15 mmol/L [95% CI: −0.27, −0.02 mmol/L]; P = 0.03) compared with control diets. No significant treatment effects were observed for fasting insulin and HOMA-IR, however the direction of effect favoured tree nuts. Limitations Majority of trials were of short duration and poor quality. Conclusions Pooled analyses show that tree nuts improve glycemic control in individuals with type 2 diabetes, supporting their inclusion in a healthy diet. Owing to the uncertainties in our analyses there is a need for longer, higher quality trials with a focus on using nuts to displace high-glycemic index carbohydrates. Trial Registration ClinicalTrials.gov NCT01630980 PMID:25076495

Effects of supportive-expressive discussion groups on loneliness, hope and quality of life in breast cancer survivors: a randomized control trial.

PubMed

Tabrizi, Fatemeh Moghaddam; Radfar, Moloud; Taei, Zeynab

2016-09-01

Evaluation of the effect of supportive expressive discussion groups on loneliness, hope and quality of life in breast cancer survivors. A randomized control trial including breast cancer patients who had completed chemotherapy and randomly allocated into two groups: intervention (n = 41) and control (n = 40). The intervention consisted of twelve weekly 90-min sessions for groups of six to eight breast cancer survivors. Data were obtained pre-to -post the intervention and at 8-week follow-up. The data were analyzed using a repeated-measures analysis of variance (ANOVA). The findings revealed a significant reduction in loneliness scores (F = 69.85, p < 0.001), promotion in total hope (F = 20.8, p < 0.05) and enhancement in quality of life from pre- to post-intervention, and then over the 8-week follow-up period in the intervention group, while scores of control participants did not show this pattern during the study. The strongest effects were found for global quality of life (effect size) = 0.59), for future perspectives (effect size = 0.51), emotional functioning (effect size = 0.35) and social functioning (effect size = 0.31). The intervention was effective on loneliness, hope and quality of life in the intervention group. The intervention needs further evaluation in a larger study and with other cancer types. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Incidence of post-operative pain after single visit and multiple visit root canal treatment: A randomized controlled trial

PubMed Central

Singh, Smita; Garg, Aniket

2012-01-01

Aim: To compare the incidence and intensity of post-obturation pain after single or multi visit root canal treatment on single rooted teeth in a randomized controlled trial. Materials and Methods: Two hundred patients requiring root canal treatment on permanent single rooted teeth (both vital and non vital) were included. The patients were assigned randomly into two groups of 100 patients each. The teeth in Group1 (n = 100) were obturated at the first visit, whilst those in Group 2 (n = 100) were obturated in a second visit 7 days later. A modified Heft Parker visual analog scale was used to measure pre-operative pain and post-obturation pain at 6, 12, 24 and 48 hours after obturation. Independent-sample T-tests was used for statistical analysis. Results: Twelve patients were excluded from the study as they failed to follow the scheduled revisit. Data were obtained from the remaining 188 patients. There was no statistically significant difference in the incidence and intensity of post-obturation pain experienced by two groups. Conclusions: The incidence and intensity of post-obturation pain experience following one- or two-visit root canal treatment on teeth with a single canal were not significantly different. PMID:23112477

Nutritively Sweetened Beverage Consumption and Body Weight: A Systematic Review and Meta-Analysis of Randomized Experiments

PubMed Central

Mattes, Richard D; Shikany, James M; Kaiser, Kathryn A; Allison, David B

2010-01-01

Nutritively sweetened beverages (NSBs) may play a role in the obesity epidemic. We abstracted data from randomized controlled trials (RCTs) and evidence-based reviews through January 2009 concerning effects of consumption of NSBs on changes in body weight and adiposity. Studies included were those 1) conducted in humans; 2) lasting at least 3 weeks; 3) incorporating random assignment of subjects to conditions that differed only in the consumption of NSBs; and 4) including an adiposity indicator as an outcome. Twelve studies met the inclusion criteria. Meta-analysis of 6 studies that added NSBs to persons’ diets showed dose-dependent increases in weight. Contrarily, meta-analysis of studies that attempted to reduce NSB consumption consistently showed no effect on BMI when all subjects were considered. Meta-analysis of studies providing access to results separately for subjects overweight at baseline showed a significant effect of a roughly 0.35 standard deviations lesser BMI change (i.e., more weight loss or less weight gain) relative to controls. The current evidence does not demonstrate conclusively that NSB consumption has uniquely contributed to obesity or that reducing NSB consumption will reduce BMI levels in general. We recommend an adequately powered RCT among overweight persons, among whom there is suggestive evidence of an effect. PMID:20524996

Evaluating clinical trial design: systematic review of randomized vehicle-controlled trials for determining efficacy of benzoyl peroxide topical therapy for acne.

PubMed

Lamel, Sonia A; Sivamani, Raja K; Rahvar, Maral; Maibach, Howard I

2015-11-01

Determined efficacies of benzoyl peroxide may be affected by study design, implementation, and vehicle effects. We sought to elucidate areas that may allow improvement in determining accurate treatment efficacies by determining rates of active treatment and vehicle responders in randomized controlled trials assessing the efficacy of topical benzoyl peroxide to treat acne. We conducted a systematic review of randomized vehicle-controlled trials evaluating the efficacy of topical benzoyl peroxide for the treatment of acne. We compared response rates of vehicle treatment arms versus those in benzoyl peroxide arms. Twelve trials met inclusion criteria with 2818 patients receiving benzoyl peroxide monotherapy treatment and 2004 receiving vehicle treatment. The average percent reduction in total number of acne lesions was 44.3 (SD = 9.2) and 27.8 (SD = 21.0) for the active and vehicle treatment groups, respectively. The average reduction in non-inflammatory lesions was 41.5 % (SD = 9.4) in the active treatment group and 27.0 % (SD = 20.9) in the vehicle group. The average percent decrease in inflammatory lesions was 52.1 (SD = 10.4) in the benzoyl peroxide group and 34.7 (SD = 22.7) in the vehicle group. The average percentage of participants achieving success per designated study outcomes was 28.6 (SD = 17.3) and 15.2 (SD = 9.5) in the active treatment and vehicle groups, respectively. Patient responses in randomized controlled trials evaluating topical acne therapies may be affected by clinical trial design, implementation, the biologic effects of vehicles, and natural disease progression. "No treatment" groups may facilitate determination of accurate treatment efficacies.

Non-invasive high-intensity focused ultrasound for UV-induced hyperpigmentation in Fitzpatrick skin types III and IV: a prospective, randomized, controlled, evaluator-blinded trial.

PubMed

Vachiramon, Vasanop; Jurairattanaporn, Natthachat; Harnchoowong, Sarawin; Chayavichitsilp, Pamela

2018-02-01

Skin hyperpigmentation is a frequently encountered problem, particularly in darker skin types. Unfortunately, standard treatments for this condition have shown disappointing results. High-intensity focused ultrasound (HIFU) is commonly indicated for skin laxity, but recently was used to treat UV-induced hyperpigmentation in animal models. This study is aimed to evaluate the efficacy and safety of high-intensity focused ultrasound for UVB-induced hyperpigmentation in human subjects. A randomized, evaluator-blinded pilot study was conducted on 20 subjects. Each subject was induced three hyperpigmentary spots by local broadband UVB. After 2 weeks, each spot was randomly allocated to control, low-energy, and high-energy HIFU. Subjects were instructed to follow up weekly for a duration of 1 month. Lightness index measurements, mean improvement scores, subjects' satisfaction, pain scores, and side effects were evaluated. All 20 subjects completed the study. Fourteen subjects had Fitzpatrick (FPT) skin type III and six subjects had FPT skin type IV. Twelve subjects showed greater improvement at control sites while eight subjects showed greater improvement at HIFU-treated sites. In FPT skin type III, HIFU appeared to be inferior to control in both lightness index and mean improvement scores, but in FPT skin type IV, HIFU had greater lightness index improvement and higher improvement scores than control. Side effects were more frequent in high-energy-treated areas. Focused ultrasound may be offered in some patients with hyperpigmentary conditions. More research is needed to determine proper energy settings for optimal outcome.

An Examination of Strategy Implementation During Abstract Nonlinguistic Category Learning in Aphasia

PubMed Central

Kiran, Swathi

2015-01-01

Purpose Our purpose was to study strategy use during nonlinguistic category learning in aphasia. Method Twelve control participants without aphasia and 53 participants with aphasia (PWA) completed a computerized feedback-based category learning task consisting of training and testing phases. Accuracy rates of categorization in testing phases were calculated. To evaluate strategy use, strategy analyses were conducted over training and testing phases. Participant data were compared with model data that simulated complex multi-cue, single feature, and random pattern strategies. Learning success and strategy use were evaluated within the context of standardized cognitive–linguistic assessments. Results Categorization accuracy was higher among control participants than among PWA. The majority of control participants implemented suboptimal or optimal multi-cue and single-feature strategies by testing phases of the experiment. In contrast, a large subgroup of PWA implemented random patterns, or no strategy, during both training and testing phases of the experiment. Conclusions Person-to-person variability arises not only in category learning ability but also in the strategies implemented to complete category learning tasks. PWA less frequently developed effective strategies during category learning tasks than control participants. Certain PWA may have impairments of strategy development or feedback processing not captured by language and currently probed cognitive abilities. PMID:25908438

Body mass index in Parkinson's disease: a meta-analysis.

PubMed

van der Marck, Marjolein A; Dicke, Heleen C; Uc, Ergun Y; Kentin, Zippora H A; Borm, George F; Bloem, Bastiaan R; Overeem, Sebastiaan; Munneke, Marten

2012-03-01

Prior work suggested that patients with Parkinson's disease (PD) have a lower Body Mass Index (BMI) than controls, but evidence is inconclusive. We therefore conducted a meta-analysis on BMI in PD. We searched MEDLINE, EMBASE, Cinahl and Scopus to identify cohort studies on BMI in PD, published before February 2011. Studies that reported mean BMI for PD patients and healthy controls were eligible. Twelve studies were included, with a total of 871 patients and 736 controls (in three studies controls consisted of subjects from other published studies). Our primary aim was to assess differences in BMI between patients and controls; this was analyzed with random effects meta-analysis. Our secondary aim was to evaluate the relation with disease severity (Hoehn and Yahr stage) and disease duration, using random effects meta-regression. PD patients had a significantly lower BMI than controls (overall effect 1.73, 95% CI 1.11-2.35, P<0.001). Pooled data of seven studies showed that patients with Hoehn and Yahr stage 3 had a lower BMI than patients with stage 2 (3.9, 95% CI 0.1-7.7, P<0.05). Disease duration was not associated with BMI. Because a low body weight is associated with negative health effects and a poorer prognosis, monitoring weight and nutritional status should be part of PD management. Copyright © 2011. Published by Elsevier Ltd.

A clinical investigation of the efficacy of two dentifrices for the reduction of supragingival calculus formation.

PubMed

Schiff, Thomas; Delgado, Evaristo; DeVizio, William; Proskin, Howard M

2008-01-01

The objective of this double-blind clinical study, conducted in harmony with Volpe-Manhold design for studies of dental calculus, was to compare the efficacy of a dentifrice containing 0.3% triclosan/2.0% polyvinylmethyl ether/maleic acid (PVM/MA) copolymer/0.243% sodium fluoride in a 17% dual silica base (Colgate Total Advanced Toothpaste) to that of a commercially available dentifrice containing 0.243% sodium fluoride in a silica base (Crest Cavity Protection Toothpaste) with respect to the reduction of supragingival calculus formation. Adult male and female subjects from the San Francisco area were entered into the eight-week pre-test phase of the study. Subjects received an evaluation of oral soft and hard tissues and were given a complete oral prophylaxis. They were provided with a non-tartar control placebo dentifrice and a soft-bristled adult toothbrush, and were instructed to brush their teeth twice daily (morning and evening) for one minute. After eight weeks of using the placebo dentifrice, subjects were examined for baseline supragingival calculus formation using the Volpe-Manhold Calculus Index. Qualifying subjects were randomized into two treatment groups which were balanced for gender and baseline calculus scores. All subjects entered into the twelve-week test phase were given a complete oral prophylaxis, and were provided with their assigned dentifrice and a soft-bristled adult toothbrush for home use. Subjects were instructed to brush their teeth for one minute twice daily (in the morning and evening). Prior to each study visit, subjects refrained from brushing their teeth and eating and drinking for four hours. Seventy-seven (77) subjects complied with the protocol and completed the study. At the twelve-week examination, the Test Dentifrice group presented a mean Volpe-Manhold Calculus Index score of 13.22 and the Control Dentifrice group presented a score of 20.29. After twelve weeks of product use, the Test Dentifrice group exhibited 34.8% less supragingival calculus formation than the Control Dentifrice group (statistically significant at p < 0.05). The overall results of this double-blind clinical study support the conclusion that after twelve weeks' use of a dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride in a 17% dual silica base provides significantly greater control of supragingival calculus formation relative to that of a commercially available dentifrice containing 0.243% sodium fluoride in a silica base.

Randomized Clinical Trial of Real-Time fMRI Amygdala Neurofeedback for Major Depressive Disorder: Effects on Symptoms and Autobiographical Memory Recall.

PubMed

Young, Kymberly D; Siegle, Greg J; Zotev, Vadim; Phillips, Raquel; Misaki, Masaya; Yuan, Han; Drevets, Wayne C; Bodurka, Jerzy

2017-08-01

Patients with depression show blunted amygdala hemodynamic activity to positive stimuli, including autobiographical memories. The authors examined the therapeutic efficacy of real-time functional MRI neurofeedback (rtfMRI-nf) training aimed at increasing the amygdala's hemodynamic response to positive memories in patients with depression. In a double-blind, placebo-controlled, randomized clinical trial, unmedicated adults with depression (N=36) were randomly assigned to receive two sessions of rtfMRI-nf either from the amygdala (N=19) or from a parietal control region not involved in emotional processing (N=17). Clinical scores and autobiographical memory performance were assessed at baseline and 1 week after the final rtfMRI-nf session. The primary outcome measure was change in score on the Montgomery-Åsberg Depression Rating Scale (MADRS), and the main analytic approach consisted of a linear mixed-model analysis. In participants in the experimental group, the hemodynamic response in the amygdala increased relative to their own baseline and to the control group. Twelve participants in the amygdala rtfMRI-nf group, compared with only two in the control group, had a >50% decrease in MADRS score. Six participants in the experimental group, compared with one in the control group, met conventional criteria for remission at study end, resulting in a number needed to treat of 4. In participants receiving amygdala rtfMRI-nf, the percent of positive specific memories recalled increased relative to baseline and to the control group. rtfMRI-nf training to increase the amygdala hemodynamic response to positive memories significantly decreased depressive symptoms and increased the percent of specific memories recalled on an autobiographical memory test. These data support a role of the amygdala in recovery from depression.

Efficacy of bupropion alone and in combination with nicotine gum

PubMed Central

Piper, Megan E.; Federman, E. Belle; McCarthy, Danielle E.; Bolt, Daniel M.; Smith, Stevens S.; Fiore, Michael C.; Baker, Timothy B.

2010-01-01

In this double-blind placebo-controlled smoking cessation treatment study, 608 participants were randomly assigned to receive active bupropion and active 4-mg gum (AA, n = 228), active bupropion and placebo gum (AP, n = 224), or placebo bupropion and placebo gum (PP, n = 156). Relative to the PP group, the AA and AP groups were each significantly more likely to be abstinent at one week, end of treatment and six months, but not twelve months post-quit. After the first week post-quit there were no differences in abstinence rates between the AA and AP groups. There were no significant individual difference variables that moderated outcome beyond one week post-quit. PMID:17763111

A randomized controlled trial of an educational intervention on Hellenic nursing staff's knowledge and attitudes on cancer pain management.

PubMed

Patiraki, Elisabeth I; Papathanassoglou, Elizabeth D E; Tafas, Cheryl; Akarepi, Vasiliki; Katsaragakis, Stelios G; Kampitsi, Anjuleta; Lemonidou, Chrysoula

2006-12-01

The purpose of this randomized controlled study was to explore the effectiveness of an educational intervention on nurses' attitudes and knowledge regarding pain management and to explore associations with nurses' characteristics. A four Solomon group experimental design was employed to assess the effect of the intervention and potential effects of pre-intervention testing. One hundred and twelve nurses were randomized to two intervention and two control groups. The intervention was based on viewing a series of educational videotapes and case scenarios. The Validated Hellenic version of the Nurses Knowledge and Attitudes Survey Regarding Pain (GV-NKASRP) was used. Pre-intervention scores revealed various limitations in regard to pain assessment and management. At the pre-test, the average number of correct answers was 17.58+/-7.58 (45.1%+/-19.3% of total questions). Pre-intervention scores differed significantly among participants with different educational backgrounds (P < 0.0001). A significant effect of pain education on total knowledge scores as well as regarding specific questions was detected. Intervention group participants provided 6.11+/-5.55 additional correct answers (15.66%+/-14.23% improvement, P < 0.0001), and they exhibited significantly improved post-test scores compared to controls (26.49+/-5.24 vs. 18.75+/-4.48; P < 0.0001). A potential negative effect of pre-test on knowledge gain for specific items and for total scores was detected. These findings suggest low pre-test knowledge scores among Hellenic oncology nurses and a significant effect of the intervention.

Pilot Randomized Controlled Trial of Titrated Subcutaneous Ketamine in Older Patients with Treatment-Resistant Depression.

PubMed

George, Duncan; Gálvez, Verònica; Martin, Donel; Kumar, Divya; Leyden, John; Hadzi-Pavlovic, Dusan; Harper, Simon; Brodaty, Henry; Glue, Paul; Taylor, Rohan; Mitchell, Philip B; Loo, Colleen K

2017-11-01

To assess the efficacy and safety of subcutaneous ketamine for geriatric treatment-resistant depression. Secondary aims were to examine if repeated treatments were safe and more effective in inducing or prolonging remission than a single treatment. In this double-blind, controlled, multiple-crossover study with a 6-month follow-up (randomized controlled trial [RCT] phase), 16 participants (≥60 years) with treatment-resistant depression who relapsed after remission or did not remit in the RCT were administered an open-label phase. Up to five subcutaneous doses of ketamine (0.1, 0.2, 0.3, 0.4, and 0.5 mg/kg) were administered in separate sessions (≥1 week apart), with one active control (midazolam) randomly inserted (RCT phase). Twelve ketamine treatments were given in the open-label phase. Mood, hemodynamic, and psychotomimetic outcomes were assessed by blinded raters. Remitters in each phase were followed for 6 months. Seven of 14 RCT-phase completers remitted with ketamine treatment. Five remitted at doses below 0.5 mg/kg. Doses ≥ 0.2 mg/kg were significantly more effective than midazolam. Ketamine was well tolerated. Repeated treatments resulted in higher likelihood of remission or longer time to relapse. Results provide preliminary evidence for the efficacy and safety of ketamine in treating elderly depressed. Dose titration is recommended for optimizing antidepressant and safety outcomes on an individual basis. Subcutaneous injection is a practical method for giving ketamine. Repeated treatments may improve remission rates (clinicaltrials.gov; NCT01441505). Copyright © 2017 American Association for Geriatric Psychiatry. All rights reserved.

Meat supplementation improves growth, cognitive, and behavioral outcomes in Kenyan children.

PubMed

Neumann, Charlotte G; Murphy, Suzanne P; Gewa, Connie; Grillenberger, Monika; Bwibo, Nimrod O

2007-04-01

A randomized, controlled school feeding study was conducted in rural Embu District, Kenya to test for a causal link between animal-source food intake and changes in micronutrient nutrition and growth, cognitive, and behavioral outcomes. Twelve primary schools were randomly assigned to 1 of 4 groups. Children in Standard I classes received the local plant-based dish githeri as a midmorning school snack supplemented with meat, milk, or fat added to equalize energy content in all feedings. The Control children received no feedings but participated in data collection. Main outcome measures assessed at baseline and longitudinally were 24-h food intake recall, anthropometry, cognitive function, physical activity, and behaviors during school free play. For cognitive function, the Meat group showed the steepest rate of increase on Raven's Progressive Matrices scores and in zone-wide school end-term total and arithmetic test scores. The Plain githeri and Meat groups performed better over time than the Milk and Control groups (P < 0.02-0.03) on arithmetic tests. The Meat group showed the greatest increase in percentage time in high levels of physical activity and in initiative and leadership behaviors compared with all other groups. For growth, in the Milk group only younger and stunted children showed a greater rate of gain in height. The Meat group showed near doubling of upper midarm muscle area, and the Milk group a smaller degree of increase. This is the first randomized, controlled feeding study to examine the effect of meat- vs. milk- vs. plant-based snacks on functional outcomes in children.

Efficacy of a Virtual Reality Commercial Gaming Device in Upper Limb Recovery after Stroke: A Randomized, Controlled Study.

PubMed

Kong, Keng-He; Loh, Yong-Joo; Thia, Ernest; Chai, Audrey; Ng, Chwee-Yin; Soh, Yan-Ming; Toh, Shirlene; Tjan, Soon-Yin

2016-10-01

To compare the efficacy of a virtual reality commercial gaming device, Nintendo wii (NW) with conventional therapy and customary care in facilitating upper limb recovery after stroke. Randomized, controlled, single-blinded study. Tertiary rehabilitation center. 105 subjects admitted to in inpatient rehabilitation program within 6 weeks of stroke onset. Subjects were randomly assigned to one of three groups of upper limb exercises: (1) NW gaming; (2) conventional therapy; (3) control. NW gaming and conventional therapy were provided fourtimes a week for 3 weeks. The main outcome measure was Fugl-Meyer assessment (FMA) of upper limb function. Secondary outcome measures included Action Research Arm Test, Functional Independence Measure, and Stroke Impact Scale. These measures were assessed at baseline, completion of intervention (week 3) and at 4 weeks and 8 weeks after completion of intervention. The primary outcome measure was the change in FMA scores at completion of intervention. The mean age was 57.5±9.8 years, and subjects were enrolled at a mean of 13.7±8.9 days after stroke. The mean baseline FMA score was 16.4±14.2. There was no difference in FMA scores between all 3 groups at the end of intervention, and at 4 and 8 weeks after completion of intervention. Similar findings were also noted for the secondary outcome measures. Twelve sessions of augmented upper limb exercises via NW gaming or conventional therapy over a 3-week period was not effective in enhancing upper limb motor recovery compared to control.

Comparing Acceptance and Commitment Group Therapy and 12-Steps Narcotics Anonymous in Addict's Rehabilitation Process: A Randomized Controlled Trial.

PubMed

Azkhosh, Manoochehr; Farhoudianm, Ali; Saadati, Hemn; Shoaee, Fateme; Lashani, Leila

2016-10-01

Objective: Substance abuse is a socio-psychological disorder. The aim of this study was to compare the effectiveness of acceptance and commitment therapy with 12-steps Narcotics Anonymous on psychological well-being of opiate dependent individuals in addiction treatment centers in Shiraz, Iran. Method: This was a randomized controlled trial. Data were collected at entry into the study and at post-test and follow-up visits. The participants were selected from opiate addicted individuals who referred to addiction treatment centers in Shiraz. Sixty individuals were evaluated according to inclusion/ exclusion criteria and were divided into three equal groups randomly (20 participants per group). One group received acceptance and commitment group therapy (Twelve 90-minute sessions) and the other group was provided with the 12-steps Narcotics Anonymous program and the control group received the usual methadone maintenance treatment. During the treatment process, seven participants dropped out. Data were collected using the psychological well-being questionnaire and AAQ questionnaire in the three groups at pre-test, post-test and follow-up visits. Data were analyzed using repeated measure analysis of variance. Results: Repeated measure analysis of variance revealed that the mean difference between the three groups was significant (P<0.05) and that acceptance and commitment therapy group showed improvement relative to the NA and control groups on psychological well-being and psychological flexibility. Conclusion : The results of this study revealed that acceptance and commitment therapy can be helpful in enhancing positive emotions and increasing psychological well-being of addicts who seek treatment.

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

PubMed

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

2012-06-01

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

The Effect of Massage on Acute Postoperative Pain in Critically and Acutely Ill Adults Post-thoracic Surgery: Systematic Review and Meta-analysis of Randomized Controlled Trials.

PubMed

Boitor, Madalina; Gélinas, Céline; Richard-Lalonde, Melissa; Thombs, Brett D

Critical care practice guidelines identify a lack of clear evidence on the effectiveness of massage for pain control. To assess the effect of massage on acute pain in critically and acutely ill adults post-thoracic surgery. Medline, Embase, CINAHL, PsychInfo, Web of Science, Scopus and Cochrane Library databases were searched. Eligible studies were randomized controlled trials (RCTs) evaluating the effect of massage compared to attention control/sham massage or standard care alone on acute pain intensity post-thoracic surgery. Twelve RCTs were included. Of these, nine evaluated massage in addition to standard analgesia, including 2 that compared massage to attention control/sham massage in the intensive care unit (ICU), 6 that compared massage to standard analgesia alone early post-ICU discharge, and 1 that compared massage to both attention control and standard care in the ICU. Patients receiving massage with analgesia reported less pain (0-10 scale) compared to attention control/sham massage (3 RCTs; N = 462; mean difference -0.80, 95% confidence interval [CI] -1.25 to -0.35; p < 0.001; I 2  = 13%) and standard care (7 RCTs; N = 1087; mean difference -0.85, 95% CI -1.28 to -0.42; p < 0.001; I 2  = 70%). Massage, in addition to pharmacological analgesia, reduces acute post-cardiac surgery pain intensity. Copyright © 2017 Elsevier Inc. All rights reserved.

Sclerostin Levels and Bone Turnover Markers in Adolescents with Anorexia Nervosa and Healthy Adolescent Girls

PubMed Central

Faje, Alexander T.; Fazeli, Pouneh K.; Katzman, Debra K.; Miller, Karen K.; Breggia, Anne; Rosen, Clifford J.; Mendes, Nara; Klibanski, Anne; Misra, Madhusmita

2012-01-01

Sclerostin, product of the SOST gene, is an important determinant of bone formation and resorption. Adolescents with anorexia nervosa (AN) have low bone density and decreased levels of bone turnover markers. However, sclerostin has not been examined in AN as a potential mediator of impaired bone metabolism. Our study objectives were to (i) assess associations of sclerostin with surrogate bone turnover markers in girls with AN and controls and (ii) examine effects of transdermal estradiol on sclerostin in AN. 69 girls (44 with AN and 25 normal-weight controls) 13–18 years old were studied at baseline. 22 AN girls were randomized to transdermal estradiol (plus cyclic medroxyprogesterone) or placebo in a double-blind study for 12 months. Sclerostin correlated positively with P1NP and CTX in controls (r = 0. 67 and 0. 53, p = 0. 0002 and 0. 005, respectively) but not in AN despite comparable levels at baseline. Changes in sclerostin over twelve months did not differ in girls randomized to estradiol or placebo. The relationship between sclerostin and bone turnover markers is disrupted in adolescent girls with AN. Despite an increase in BMD with estradiol administration in AN, estrogen does not impact sclerostin levels in this group. PMID:22728230

A Systematic Review and Meta-analysis of the Association Between Giardia lamblia and Endemic Pediatric Diarrhea in Developing Countries

PubMed Central

Muhsen, Khitam; Levine, Myron M.

2012-01-01

We performed a systematic literature review and meta-analysis examining the association between diarrhea in young children in nonindustrialized settings and Giardia lamblia infection. Eligible were case/control and longitudinal studies that defined the outcome as acute or persistent (>14 days) diarrhea, adjusted for confounders and lasting for at least 1 year. Data on G. lamblia detection (mainly in stools) from diarrhea patients and controls without diarrhea were abstracted. Random effects model meta-analysis obtained pooled odds ratios (ORs) and 95% confidence intervals (CIs). Twelve nonindustrialized-setting acute pediatric diarrhea studies met the meta-analysis inclusion criteria. Random-effects model meta-analysis of combined results (9774 acute diarrhea cases and 8766 controls) yielded a pooled OR of 0.60 (95% CI, .38–.94; P = .03), indicating that G. lamblia was not associated with acute diarrhea. However, limited data suggest that initial Giardia infections in early infancy may be positively associated with diarrhea. Meta-analysis of 5 persistent diarrhea studies showed a pooled OR of 3.18 (95% CI, 1.50–6.76; P < .001), positively linking Giardia with that syndrome. The well-powered Global Enteric Multicenter Study (GEMS) is prospectively addressing the association between G. lamblia infection and diarrhea in children in developing countries. PMID:23169940

The Impact of an Antimicrobial Utilization Program on Antimicrobial Use at a Large Teaching Hospital: A Randomized Controlled Trial

PubMed Central

Camins, Bernard C.; King, Mark D.; Wells, Jane B.; Googe, Heidi L.; Patel, Manish; Kourbatova, Ekaterina V.; Blumberg, Henry M.

2009-01-01

Background Multidisciplinary antimicrobial utilization teams (AUT) have been proposed as a mechanism for improving antimicrobial use, but data on their efficacy remain limited. Objective To determine the impact of an AUT on antimicrobial use at a teaching hospital. Design Randomized controlled intervention trial. Setting A 953-bed public university-affiliated urban teaching hospital. Patients Patients who were prescribed selected antimicrobial agents (piperacillin-tazobactam, levofloxacin, or vancomycin) by internal medicine ward teams. Intervention Twelve internal medicine teams were randomized monthly: 6 teams to intervention group (academic detailing by the AUT), and 6 teams to a control group given indication-based guidelines for prescription of broad spectrum antimicrobials (standard of care) during a 10-month study period. Measurements Proportion of appropriate empiric, definitive (therapeutic), and end antimicrobial (overall) usage. Results A total of 784 new prescriptions of piperacillin-tazobactam, levofloxacin, and vancomycin were reviewed. The proportion of appropriate antimicrobial prescriptions written by the intervention teams was significantly higher than prescribed by the control teams: 82% vs. 73% for empiric (RR=1.14, 95% CI 1.04–1.24), 82% vs. 43% for definitive (RR=1.89, 95% CI 1.53–2.33), and 94% vs. 70% for end antimicrobial usage (RR=1.34, 95% CI 1.25–1.43). In a multivariate analysis, teams that received feedback from the AUT alone (aRR=1.37, 95% CI 1.27–1.48) or from both the AUT and the ID consult service (aRR=2.28, 95% CI 1.64–3.19) were significantly more likely to prescribe end antimicrobial usage appropriately compared to control teams. Conclusions A multidisciplinary AUT which provides feedback to prescribing physicians was an effective method in improving antimicrobial use. PMID:19712032

Effects of a lifestyle intervention on psychosocial well-being of severe mentally ill residential patients: ELIPS, a cluster randomized controlled pragmatic trial.

PubMed

Stiekema, Annemarie P M; Looijmans, Anne; van der Meer, Lisette; Bruggeman, Richard; Schoevers, Robert A; Corpeleijn, Eva; Jörg, Frederike

2018-03-01

Large studies investigating the psychosocial effects of lifestyle interventions in patients with a severe mental illness (SMI) are scarce, especially in residential patients. This large, randomized controlled, multicentre pragmatic trial assessed the psychosocial effects of a combined diet-and-exercise lifestyle intervention targeting the obesogenic environment of SMI residential patients. Twenty-nine sheltered and clinical care teams were randomized into intervention (n=15) or control (n=14) arm. Team tailored diet-and-exercise lifestyle plans were set up to change the obesogenic environment into a healthier setting, and team members were trained in supporting patients to make healthier choices. The control group received care-as-usual. The Calgary Depression Scale for Schizophrenia (CDSS), Positive and Negative Syndrome Scale (PANSS), Health of the Nation Outcome Scales (HoNOS) and the Manchester Short Assessment of Quality of Life (MANSA) were assessed at baseline and after three and twelve months. Data were available for 384 intervention and 386 control patients (48.6±12.5years old, 62.7% males, 73.7% psychotic disorder). Linear mixed model analysis showed no psychosocial improvements in the intervention group compared to care-as-usual; the intervention group showed a slightly reduced quality of life (overall) and a small increase in depressive symptoms (clinical care facilities) and psychotic symptoms (sheltered facilities). This may be due to difficulties with implementation, the intervention not being specifically designed for improvements in mental well-being, or the small change approach, which may take longer to reach an effect. Further research might elucidate what type of lifestyle intervention under what circumstances positively affects psychosocial outcomes in this population. Copyright © 2018 Elsevier B.V. All rights reserved.

Effectiveness of cognitive-behavioural therapy on glycaemic control and psychological outcomes in adults with diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Uchendu, C; Blake, H

2017-03-01

Diabetes is a chronic progressive condition presenting physical, social and psychological challenges that increase the risk of comorbid mental health problems. Cognitive-behavioural therapy (CBT) is effective in treating a variety of psychological disorders, and may potentially improve glycaemic control and psychological outcomes in diabetes. This systematic review and meta-analysis aims to establish the effectiveness of CBT on glycaemic control and comorbid diabetes-related distress, depression, anxiety and quality of life in the short, medium and longer term among adults with diabetes. An electronic search was conducted in PubMed, Embase, MEDLINE, PsycINFO, CINAHL, Web of Knowledge, Cochrane Central Register of Controlled Trials and references in reviews. Twelve randomized controlled trials (RCTs) were identified that evaluated the effectiveness of CBT on at least one of: glycaemic control, diabetes-related distress, anxiety, depression or quality of life in adults with Type 1 or Type 2 diabetes. The Cochrane Risk of Bias Tool and Review Manager version 5.3 were used for risk of bias assessment and meta-analysis, respectively. CBT is effective in reducing short-term and medium-term glycaemic control, although no significant effect was found for long-term glycaemic control. CBT improved short- and medium-term anxiety and depression, and long-term depression. Mixed results were found for diabetes-related distress and quality of life. CBT is beneficial in improving depression for adults with diabetes. It may have benefits for improving glycaemic control and other aspects of psychological health, although the findings are inconclusive. © 2016 Diabetes UK.

Effectiveness of an Energy Management Training Course on Employee Well-Being: A Randomized Controlled Trial.

PubMed

Das, Sai Krupa; Mason, Shawn T; Vail, Taylor A; Rogers, Gail V; Livingston, Kara A; Whelan, Jillian G; Chin, Meghan K; Blanchard, Caroline M; Turgiss, Jennifer L; Roberts, Susan B

2018-01-01

Programs focused on employee well-being have gained momentum in recent years, but few have been rigorously evaluated. This study evaluates the effectiveness of an intervention designed to enhance vitality and purpose in life by assessing changes in employee quality of life (QoL) and health-related behaviors. A worksite-based randomized controlled trial. Twelve eligible worksites (8 randomized to the intervention group [IG] and 4 to the wait-listed control group [CG]). Employees (n = 240) at the randomized worksites. A 2.5-day group-based behavioral intervention. Rand Medical Outcomes Survey (MOS) 36-item Short-Form (SF-36) vitality and QoL measures, Ryff Purpose in Life Scale, Center for Epidemiologic Studies questionnaire for depression, MOS sleep, body weight, physical activity, diet quality, and blood measures for glucose and lipids (which were used to calculate a cardiometabolic risk score) obtained at baseline and 6 months. General linear mixed models were used to compare least squares means or prevalence differences in outcomes between IG and CG participants. As compared to CG, IG had a significantly higher mean 6-month change on the SF-36 vitality scale ( P = .003) and scored in the highest categories for 5 of the remaining 7 SF-36 domains: general health ( P = .014), mental health ( P = .027), absence of role limitations due to physical problems ( P = .026), and social functioning ( P = .007). The IG also had greater improvements in purpose in life ( P < .001) and sleep quality (index I, P = .024; index II, P = .021). No statistically significant changes were observed for weight, diet, physical activity, or cardiometabolic risk factors. An intensive 2.5-day intervention showed improvement in employee QoL and well-being over 6 months.

Safety and metabolic outcomes of resveratrol supplementation in older adults: results of a twelve-week, placebo-controlled pilot study

PubMed Central

Anton, Stephen D.; Embry, Chelsea; Marsiske, Michael; Lud, Xiaomin; Doss, Hani; Leeuwenburgh, Christiaan; Manini, Todd M.

2014-01-01

Resveratrol has been found to have potent antioxidant, anti-inflammatory, and anticarcinogenic effects. The safety and efficacy of resveratrol supplementation in older adults are currently unknown. We conducted a double-blind, randomized, placebo-controlled trial to examine the safety and metabolic outcomes in 32 overweight, older adults (mean age, 73 ± 7 years). Participants were randomized into one of three treatment groups: (1) placebo, (2) moderate dose resveratrol (300 mg/day), and (3) high dose resveratrol (1000 mg/day). Both resveratrol and placebo were orally ingested in capsule form twice daily for 90 days. Blood chemistry values remained within the normal range, and there were no significant differences in the number of participants reporting adverse events across conditions. Compared to placebo, glucose levels were significantly lower at post-treatment among participants randomized to both resveratrol conditions, with and without adjustment for the corresponding baseline values (ps < 0.05). Glucose values of participants in the treatment groups, however, were not significantly different from baseline levels. These findings suggest that short-term resveratrol supplementation at doses of 300 mg/day and 1000 mg/day does not adversely affect blood chemistries and is well tolerated in overweight, older individuals. These findings support the study of resveratrol for improving cardio-metabolic health in older adults in larger clinical trials. PMID:24866496

Literature Review and Meta-Analysis of Transcutaneous Electrical Nerve Stimulation in Treating Chronic Back Pain

PubMed Central

Wu, Lien-Chen; Weng, Pei-Wei; Chen, Chia-Hsien; Huang, Yi-You; Tsuang, Yang-Hwei; Chiang, Chang-Jung

2018-01-01

Background and Objectives This study is a meta-analysis of randomized controlled trials comparing the efficacy of transcutaneous electrical nerve stimulation (TENS) to a control and to other nerve stimulation therapies (NSTs) for the treatment of chronic back pain. Methods Citations were identified in MEDLINE, the Cochrane Library, Google Scholar, and ClinicalTrials.gov through June 2014 using the following keywords: nerve stimulation therapy, transcutaneous electrical nerve stimulation, back pain, chronic pain. Control treatments included sham, placebo, or medication only. Other NSTs included electroacupuncture, percutaneous electrical nerve stimulation, and percutaneous neuromodulation therapy. Results Twelve randomized controlled trials including 700 patients were included in the analysis. The efficacy of TENS was similar to that of control treatment for providing pain relief (standardized difference in means [SDM] = −0.20; 95% confidence interval [CI], −0.58 to 0.18; P = 0.293). Other types of NSTs were more effective than TENS in providing pain relief (SDM = 0.86; 95% CI, 0.15–1.57; P = 0.017). Transcutaneous electrical nerve stimulation was more effective than control treatment in improving functional disability only in patients with follow-up of less than 6 weeks (SDM = −1.24; 95% CI, −1.83 to −0.65; P < 0.001). There was no difference in functional disability outcomes between TENS and other NSTs. Conclusions These results suggest that TENS does not improve symptoms of lower back pain, but may offer short-term improvement of functional disability. PMID:29394211

A randomized controlled trial on the effects of combined aerobic-resistance exercise on muscle strength and fatigue, glycemic control and health-related quality of life of type 2 diabetes patients.

PubMed

Tomas-Carus, Pablo; Ortega-Alonso, Alfredo; Pietilainen, Kirsi H; Santos, Vitoria; Goncalves, Helena; Ramos, Jorge; Raimundo, Armando

2016-05-01

The aim of this paper was to evaluate the effects of a 12-weeks combined aerobic-resistance exercise therapy on fatigue and isokinetic muscle strength, glycemic control and health-related quality of life (HRQoL) in moderately affected type 2 diabetes (T2DM) patients. A randomized controlled trial design was employed. Forty-three T2DM patients were assigned to an exercise group (N.=22), performing 3 weekly sessions of 60 minutes of combined aerobic-resistance exercise for 12-weeks; or a no exercise control group (N.=21). Both groups were evaluated at a baseline and after 12-weeks of exercise therapy for: 1) muscle strength and fatigue by isokinetic dynamometry; 2) plasma glycated hemoglobin A1C (HbA1C); and 3) HRQoL utilizing the SF-36 questionnaire. The exercise therapy led to improvements in muscle fatigue in knee extensors (-55%) and increased muscle strength in knee flexors and extensors (+15 to +30%), while HbA1C decreased (-18%). In addition, the exercising patients showed sizeable improvements in HRQoL: physical function (+53%), vitality (+21%) and mental health (+40%). Twelve-weeks of combined aerobic-resistance exercise was highly effective to improve muscle strength and fatigue, glycemic control and several aspects of HRQoL in T2DM patients. These data encourage the use of aerobic and resistance exercise in the good clinical care of T2DM.

Postoperative treatment of metacarpal fractures-Classical physical therapy compared with a home exercise program.

PubMed

Gülke, Joachim; Leopold, Barbara; Grözinger, Daniel; Drews, Björn; Paschke, Stephan; Wachter, Nikolaus J

Prospective cohort randomized controlled trial. Is either a home exercise (HE) program or traditional physical therapy (PT) more effective in the postoperative management of metacarpal fractures? Sixty patients suffering from nonthumb metacarpal fractures who received mobilization-stable open reduction and internal fixation were included. All patients were prospectively randomized into either the PT group or the HE group. Follow-up examinations at 2, 6 and 12 weeks postoperatively. After 2 weeks, the range of motion (ROM) in both groups was still severely reduced. Twelve weeks after surgery the ROM improved to 245° (PT) and 256° (HE). Grip strength after 6 weeks was 68% (PT) and 71% (HE) when compared to the non-injured hand, improving to 91% (PT) and 93% (HE) after 12 weeks. Study results show that both HE program and traditional PT are effective in the postoperative management of metacarpal fractures. II. Copyright © 2017 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

Design and evaluation of an aerial spray trial with true replicates to test the efficacy of Bacillus thuringiensis insecticide in a boreal forest.

PubMed

Cadogan, Beresford L; Scharbach, Roger D

2003-04-01

A field trial using true replicates was conducted successfully in a boreal forest in 1996 to evaluate the efficacy of two aerially applied Bacillus thuringiensis formulations, ABG 6429 and ABG 6430. A complete randomized design with four replicates per treatment was chosen. Twelve to 15 balsam fir (Abies balsamea [L.] Mill.) per plot were randomly selected as sample trees. Interplot buffer zones, > or = 200 m wide, adequately prevented cross contamination from sprays that were atomized with four rotary atomizers (volume median diameters ranging from 64.6 to 139.4 microm) and released approximately 30 m above the ground. The B. thuringiensis formulations were not significantly different (P > 0.05) from each other in reducing spruce budworm (Choristoneura fumiferana [Clem.]) populations and protecting balsam trees from defoliation but both formulations were significantly more efficacious than the controls. The results suggest that true replicates are a feasible alternative to pseudoreplication in experimental forest aerial applications.

A systematic review of studies of web portals for patients with diabetes mellitus.

PubMed

Coughlin, Steven S; Williams, Lovoria B; Hatzigeorgiou, Christos

2017-01-01

Patient web portals are password-protected online websites that offer patients 24-hour access to personal health information from anywhere with an Internet connection. Due to advances in health information technologies, there has been increasing interest among providers and researchers in patient web portals for use by patients with diabetes and other chronic conditions. This article, which is based upon bibliographic searches in PubMed, reviews web portals for patients with diabetes mellitus including patient web portals tethered to electronic medical records and web portals developed specifically for patients with diabetes. Twelve studies of the impact of patient web portals on the management of diabetes patients were identified. Three had a cross-sectional design, 1 employed mixed-methods, one had a matched-control design, 3 had a retrospective cohort design, and 5 were randomized controlled trials. Six (50%) of the studies examined web portals tethered to electronic medical records and the remainder were web portals developed specifically for diabetes patients. The results of this review suggest that secure messaging between adult diabetic patients and their clinician is associated with improved glycemic control. However, results from observational studies indicate that many diabetic patients do not take advantage of web portal features such as secure messaging, perhaps because of a lack of internet access or lack of experience in navigating web portal resources. Although results from randomized controlled trials provide stronger evidence of the efficacy of web portal use in improving glycemic control among diabetic patients, the number of trials is small and results from the trials have been mixed. Studies suggest that secure messaging between adult diabetic patients and their clinician is associated with improved glycemic control, but negative findings have also been reported. The number of randomized controlled trials that have examined the efficacy of web portal use in improving glycemic control among diabetic patients is still small. Additional research is needed to identify specific portal features that may impact quality of care or improve glycemic control.

A systematic review of studies of web portals for patients with diabetes mellitus

PubMed Central

Williams, Lovoria B.; Hatzigeorgiou, Christos

2017-01-01

Patient web portals are password-protected online websites that offer patients 24-hour access to personal health information from anywhere with an Internet connection. Due to advances in health information technologies, there has been increasing interest among providers and researchers in patient web portals for use by patients with diabetes and other chronic conditions. This article, which is based upon bibliographic searches in PubMed, reviews web portals for patients with diabetes mellitus including patient web portals tethered to electronic medical records and web portals developed specifically for patients with diabetes. Twelve studies of the impact of patient web portals on the management of diabetes patients were identified. Three had a cross-sectional design, 1 employed mixed-methods, one had a matched-control design, 3 had a retrospective cohort design, and 5 were randomized controlled trials. Six (50%) of the studies examined web portals tethered to electronic medical records and the remainder were web portals developed specifically for diabetes patients. The results of this review suggest that secure messaging between adult diabetic patients and their clinician is associated with improved glycemic control. However, results from observational studies indicate that many diabetic patients do not take advantage of web portal features such as secure messaging, perhaps because of a lack of internet access or lack of experience in navigating web portal resources. Although results from randomized controlled trials provide stronger evidence of the efficacy of web portal use in improving glycemic control among diabetic patients, the number of trials is small and results from the trials have been mixed. Studies suggest that secure messaging between adult diabetic patients and their clinician is associated with improved glycemic control, but negative findings have also been reported. The number of randomized controlled trials that have examined the efficacy of web portal use in improving glycemic control among diabetic patients is still small. Additional research is needed to identify specific portal features that may impact quality of care or improve glycemic control. PMID:28736732

School gardens and physical activity: a randomized controlled trial of low-income elementary schools.

PubMed

Wells, Nancy M; Myers, Beth M; Henderson, Charles R

2014-12-01

This study examines effects of a school garden intervention on elementary school children's physical activity (PA). Twelve schools in New York were randomly assigned to receive the school garden intervention (n=6) or to the waitlist control group that later received gardens (n=6). PA was measured by self-report survey (Girls Health Enrichment Multi-site Study Activity Questionnaire) (N=227) and accelerometry (N=124, 8 schools) at baseline (Fall 2011) and follow-up (Spring 2012, Fall 2012, Spring 2013). Direct observation (N=117, 4 schools) was employed to compare indoor (classroom) and outdoor (garden) PA. Analysis was by general linear mixed models. Survey data indicate garden intervention children's reports of usual sedentary activity decreased from pre-garden baseline to post-garden more than the control group children's (Δ=-.19, p=.001). Accelerometry data reveal that during the school day, children in the garden intervention showed a greater increase in percent of time spent in moderate and moderate-to-vigorous PA from baseline to follow-up than the control group children (Δ=+.58, p=.010; Δ=+1.0, p=.044). Direct observation within-group comparison of children at schools with gardens revealed that children move more and sit less during an outdoor garden-based lesson than during an indoor, classroom-based lesson. School gardens show some promise to promote children's PA. clinicaltrials.gov # NCT02148315. Copyright © 2014 Elsevier Inc. All rights reserved.

Early Intervention for Preterm Infants and Their Mothers: A Systematic Review.

PubMed

Zhang, Xin; Kurtz, Melissa; Lee, Shih-Yu; Liu, Huaping

2014-11-18

This systematic review evaluates the efficacy of various early interventions on maternal emotional outcomes, mother-infant interaction, and subsequent infant outcomes during neonatal intensive care unit admission and postdischarge. Key interventions associated with outcomes in both the neonatal intensive care unit and postdischarge (ie, home) settings are summarized. A comprehensive search of peer-reviewed randomized controlled trials involving early interventions for infants and their mother published between 1993 and 2013 in the electronic databases PubMed, CINAHL, EMBASE, PsychINFO, and Cochrane was undertaken. Methodological quality was assessed using the PEDro scale to evaluate internal and external validity of the study. Twelve randomized controlled trials were included in the review, and all used some form of parenting education. The interventions had limited effects on maternal stress and mother-infant interaction and positive effects on maternal anxiety, depressive symptoms, and maternal coping. There were positive effects on infants' short-term outcomes for length of stay and breast-feeding rate. Positive and clinically meaningful effects of early interventions were seen in some physiological/psychological outcomes of mothers and preterm infants. It is important for nurses to foster close mother-infant contact and increase maternal competence during and after the infant's hospitalization period.

Photodynamic therapy on bacterial reduction in dental caries: in vivo study

NASA Astrophysics Data System (ADS)

Baptista, Alessandra; Araujo Prates, Renato; Kato, Ilka Tiemy; Amaral, Marcello Magri; Zanardi de Freitas, Anderson; Simões Ribeiro, Martha

2010-04-01

The reduction of pathogenic microorganisms in supragingival plaque is one of the principal factors in caries prevention and control. A large number of microorganisms have been reported to be inactivated in vitro by photodynamic therapy (PDT). The purpose of this study was to develop a rat model to investigate the effects of PDT on bacterial reduction in induced dental caries. Twenty four rats were orally inoculated with Streptococcus mutans cells (ATCC 25175) for three consecutive days. The animals were fed with a cariogenic diet and water with 10% of sucrose ad libitum, during all experimental period. Caries lesion formation was confirmed by Optical Coherence Tomography (OCT) 5 days after the beginning of the experiment. Then, the animals were randomly divided into two groups: Control Group: twelve animals were untreated by either light or photosensitizer; and PDT Group: twelve animals were treated with 100μM of methylene blue for 5min and irradiated by a Light Emitting Diode (LED) at λ = 640+/-30nm, fluence of 172J/cm2, output power of 240mW, and exposure time of 3min. Microbiological samples were collected before, immediately after, 3, 7 and 10 days after treatment and the number of total microaerophiles was counted. OCT images showed areas of enamel demineralization on rat molars. Microbiological analysis showed a significant bacterial reduction after PDT. Furthermore, the number of total microaerophiles in PDT group remained lower than control group until 10 days posttreatment. These findings suggest that PDT could be an alternative approach to reduce bacteria in dental caries.

Combined effects of astragalus soup and persistent Taiji boxing on improving the immunity of elderly women.

PubMed

Song, Qing-Hua; Xu, Rong-Mei; Zhang, Quan-Hai; Shen, Guo-Qing; Ma, Ming; Zhao, Xin-Ping; Guo, Yan-Hua; Wang, Yi

2014-01-01

To observe the combined effects of astragalus soup and persistent Taiji boxing on improving the immunity of women of advanced years. 120 elderly women lacking daily exercise were chosen as the study subjects. By using the table of random numbers, they were then divided into the control group and the experiment group, consisting of 60 each. The control group practiced Taiji boxing for 45 minutes twice a day. The experiment group did the same, and, in addition, took astragalus soup after each boxing. Indexes related to physical immunity of the two groups were observed and compared when they were first chosen, when the alternative treatment was applied three, six and twelve months later, respectively. The two groups demonstrated no significant differences in general data and research indexes when chosen (P > 0.05). Three months after the two groups were chosen and treated differently, the control group demonstrated no significant improvement while most indexes of the experiment group improved considerably (P > 0.05). After six months, the related indexes of both groups improved substantially (P < 0.05) and the improvement with the experiment was even clearer (P < 0.05). Twelve months later, the improvement with the experiment group was more noticeable (P < 0.01 or P < 0.05). In a relatively short period of three months, Taiji boxing produces no noticeable effect on the improvement of immunity in elderly women. However, when they resume the exercise for another three months and longer, Taiji boxing has a noticeable advantage and the effect is the most favorable when it is combined with astragalus soup.

[The affect of Erigeron Breviscapus (Vant.) Hand-Mazz on axoplasmic transport of optic nerve in rats with experimentally elevated intraocular pressure].

PubMed

Zhu, Y; Jiang, Y; Liu, Z; Luo, X; Wu, Z

2000-07-01

To investigate whether Erigeron Breviscapus (Vant.) Hand-Mazz (EBHM) can improve the optic nerve axoplasmic transport in rats with experimentally elevated intraocular pressure (IOP). Thirty healthy SD rats were used for the study, acute elevated IOP model in the right eye was built, then they were divided into three groups randomly: Group A (0 day group) included six rats for retinal ganglion cell (RGC) counting via left superior colliculus retrograde horse radish perokidase labeling; Group B, twelve rats divided into EBHM treatment group and control group (6 rats in each subgroup) for RGC counting via left superior colliculus retrograde labeling after twenty days, and Group C included twelve rats submitted the same treatment and procedure as group B after 40 days. After 0 day of acute elevated IOP, no labeled RGCs were observed. After twenty days of acute elevated IOP, in the control and EBHM subgroups the density of labeled RGCs were (423 +/- 220)/mm(2) and (749 +/- 294)/mm(2) respectively, the difference between two subgroups showed statistical significance (P < 0.01). After 40 days of acute elevated IOP, the density of RGCs in the control and EBHM subgroups in group C were (610 +/- 315)/mm(2) and (1,048 +/- 393)/mm(2) respectively, the difference between the two subgroups being statistically significant (P < 0.01). After 20 days and 40 days of acute elevation of IOP, the density of RGCs is obviously higher in EBHM group than that in the control group. It is revealed that EBHM can improve the optic nerve axoplasmic transportation blocked by acute elevation of IOP in rats.

Effect of Fruit Juice on Glucose Control and Insulin Sensitivity in Adults: A Meta-Analysis of 12 Randomized Controlled Trials

PubMed Central

Mi, Mantian; Wang, Jian

2014-01-01

Background Diabetes mellitus has become a worldwide health problem. Whether fruit juice is beneficial in glycemic control is still inconclusive. This study aimed to synthesize evidence from randomized controlled trials on fruit juice in relationship to glucose control and insulin sensitivity. Methods A strategic literature search of PubMed, EMBASE, and the Cochrane Library (updated to March, 2014) was performed to retrieve the randomized controlled trials that evaluated the effects of fruit juice on glucose control and insulin sensitivity. Study quality was assessed using the Jadad scale. Weighted mean differences were calculated for net changes in the levels of fasting glucose, fasting insulin, hemoglobin A1c (HbA1c), and homeostatic model assessment of insulin resistance (HOMA-IR) using fixed- or random-effects model. Prespecified subgroup and sensitivity analyses were performed to explore the potential heterogeneity. Results Twelve trials comprising a total of 412 subjects were included in the current meta-analysis. The numbers of these studies that reported the data on fasting glucose, fasting insulin, HbA1c and HOMA-IR were 12, 5, 3 and 3, respectively. Fruit juice consumption did not show a significant effect on fasting glucose and insulin concentrations. The net change was 0.79 mg/dL (95% CI: −1.44, 3.02 mg/dL; P = 0.49) for fasting glucose concentrations and −0.74 µIU/ml (95% CI: −2.62, 1.14 µIU/ml; P = 0.44) for fasting insulin concentrations in the fixed-effects model. Subgroup analyses further suggested that the effect of fruit juice on fasting glucose concentrations was not influenced by population region, baseline glucose concentration, duration, type of fruit juice, glycemic index of fruit juice, fruit juice nutrient constitution, total polyphenols dose and Jadad score. Conclusion This meta-analysis showed that fruit juice may have no overall effect on fasting glucose and insulin concentrations. More RCTs are warranted to further clarify the association between fruit juice and glycemic control. PMID:24743260

Nitrofurantoin vs other prophylactic agents in reducing recurrent urinary tract infections in adult women: a systematic review and meta-analysis.

PubMed

Price, Jameca Renee; Guran, Larissa A; Gregory, W Thomas; McDonagh, Marian S

2016-11-01

The clinical and financial burden from bladder infections is significant. Daily antibiotic use is the recommended strategy for recurrent urinary tract infection prevention. Increasing antibiotic resistance rates, however, require immediate identification of innovative alternative prophylactic therapies. This systematic review aims to provide guidance on gaps in evidence to guide future research. The objective of this review was to provide current pooled estimates of randomized control trials comparing the effects of nitrofurantoin vs other agents in reducing recurrent urinary tract infections in adult, nonpregnant women and assess relative adverse side effects. Data sources included the following: MEDLINE, Jan. 1, 1946, to Jan. 31, 2015; Cochrane Central Register of Controlled Trials the Cochrane Database of Systematic Reviews, and web sites of the National Institute for Clinical Excellence, and the National Guideline Clearinghouse from 2000 to 2015. Randomized control trials of women with recurrent urinary tract infections comparing nitrofurantoin with any other treatment were included. A protocol for the study was developed a priori. Published guidance was followed for assessment of study quality. All meta-analyses were performed using random-effects models with Stats Direct Software. Dual review was used for all decisions and data abstraction. Twelve randomized control trials involving 1063 patients were included. One study that had a serious flaw was rated poor in quality, one study rated good, and the remainder fair. No significant differences in prophylactic antibiotic treatment with nitrofurantoin and norfloxacin, trimethoprim, sulfamethoxazole/trimethoprim, methamine hippurate, estriol, or cefaclor were found in clinical or microbiological cure in adult nonpregnant women with recurrent urinary tract infections (9 randomized control trials, 673 patients, relative risk ratio, 1.06; 95% confidence interval, 0.89-1.27; I 2 , 65%; and 12 randomized control trials, 1063 patients, relative risk ratio, 1.06; 95% confidence interval, 0.90-1.26; I 2 , 76%, respectively). Duration of prophylaxis also did not have a significant impact on outcomes. There was a statistically significant difference in overall adverse effects, with nitrofurantoin resulting in greater risk than other prophylactic treatments (10 randomized control trials, 948 patients, relative risk ratio, 2.17; 95% confidence interval, 1.34-3.50; I 2 , 61%). Overall, the majority of nitrofurantoin adverse effects were gastrointestinal, with a significant difference for withdrawals (12 randomized control trials, 1063 patients, relative risk ratio, 2.14; 95% confidence interval, 1.28-3.56; I 2 , 8%). Nitrofurantoin had similar efficacy but a greater risk of adverse events than other prophylactic treatments. Balancing the risks of adverse events, particularly gastrointestinal symptoms, with potential benefits of decreasing collateral ecological damage should be considered if selecting nitrofurantoin. Copyright © 2016 Elsevier Inc. All rights reserved.

Warm-needle moxibustion for spasticity after stroke: A systematic review of randomized controlled trials.

PubMed

Yang, Liu; Tan, Jing-Yu; Ma, Haili; Zhao, Hongjia; Lai, Jinghui; Chen, Jin-Xiu; Suen, Lorna K P

2018-03-22

Spasticity is a common post-stroke complication, and it results in substantial deterioration in the quality of life of patients. Although potential positive effects of warm-needle moxibustion on spasticity after stroke have been observed, evidence on its definitive effect remains uncertain. This study aimed to summarize clinical evidence pertaining to therapeutic effects and safety of warm-needle moxibustion for treating spasticity after stroke. Randomized controlled trials were reviewed systematically on the basis of the Cochrane Handbook for Systematic Reviews of Interventions. The report follows the PRISMA statement. Ten electronic databases (PubMed, CENTRAL, EMBASE, AMED, CINAHL, Web of Science, CBM, CNKI, WanFang, and VIP) were explored, and articles were retrieved manually from two Chinese journals (The Journal of Traditional Chinese Medicine and Zhong Guo Zhen Jiu) through retrospective search. Randomized controlled trials with warm-needle moxibustion as treatment intervention for patients with limb spasm after stroke were included in this review. The risk of bias assessment tool was utilized in accordance with Cochrane Handbook 5.1.0. All included studies reported spasm effect as primary outcome. Effect size was estimated using relative risk, standardized mean difference, or mean difference with a corresponding 95% confidence interval. Review Manager 5.3 was utilized for meta-analysis. Twelve randomized controlled trials with certain methodological flaws and risk of bias were included, and they involved a total of 878 participants. Warm-needle moxibustion was found to be superior to electroacupuncture or acupuncture in reducing spasm and in promoting motor function and daily living activities. Pooled results for spasm effect and motor function were significant when warm-needle moxibustion was compared with electroacupuncture or acupuncture. A comparison of daily living activities indicated significant differences between warm-needle moxibustion and electroacupuncture. However, no difference was observed between warm-needle moxibustion and acupuncture. Warm-needle moxibustion may be a promising intervention to reduce limb spasm as well as improve motor function and daily living activities for stroke patients with spasticity. However, evidence was not conclusive. Rigorously designed randomized controlled trials with sample sizes larger than that in the included trials should be conducted for verification. Copyright © 2018 Elsevier Ltd. All rights reserved.

Randomized trial of standard pain control with or without gabapentin for pain related to radiation-induced mucositis in head and neck cancer.

PubMed

Kataoka, Tomoko; Kiyota, Naomi; Shimada, Takanobu; Funakoshi, Yohei; Chayahara, Naoko; Toyoda, Masanori; Fujiwara, Yutaka; Nibu, Ken-Ichi; Komori, Takahide; Sasaki, Ryohei; Mukohara, Toru; Minami, Hironobu

2016-12-01

Radiation-induced mucositis (RIM) in chemoradiotherapy (CRT) for head and neck cancer (HNC) causes severe pain and worsens CRT compliance, QOL and outcome. Following retrospective reports, we conducted a randomized trial of the safety and efficacy of gabapentin for RIM-associated pain during CRT. HNC patients (pts) receiving CRT were randomized to standard pain control (SPC) with acetaminophen and opioids, or SPC plus gabapentin (SPC+G). Gabapentin was maintained at 900mg/day for 4 weeks after CRT. Primary endpoint was maximum visual analogue scale (VAS) score during CRT, and secondary endpoints were total opioid dose, changes in QOL (EORTC QLQ-C30 and QLQ-HN 35) from baseline to 4 weeks after CRT, and adverse events. Twenty-two eligible Stage III or IV pts were randomly assigned to SPC or SPC+G (n=11 each). Twelve were treated in a locally advanced setting and 10 in a postoperative setting. Median maximum VAS scores, median total dose of opioids at maximum VAS and total dose of opioids at 4 weeks after CRT tended to be higher in the SPC+G arm (47 in SPC vs. 74 in SPC+G, p=0.517; 215mg vs. 745.3mg, p=0.880; and 1260mg vs. 1537.5mg, p=0.9438, respectively), without significance. QOL analysis showed significantly worse scores in the SPC+G arm for weight gain (p=0.005). Adverse events related to gabapentin were manageable. This pilot study is the first prospective randomized trial of gabapentin for RIM-related pain. Gabapentin had no apparent beneficial effect. Further research into agents for RIM-related pain is warranted. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

The use of fibrin tissue adhesive to reduce blood loss and the need for blood transfusion after total knee arthroplasty. A prospective, randomized, multicenter study.

PubMed

Levy, O; Martinowitz, U; Oran, A; Tauber, C; Horoszowski, H

1999-11-01

Total knee arthroplasty is associated with major postoperative blood loss of approximately 800 to 1200 milliliters, and blood transfusion is frequently required. With the increased concern about the risks of blood transfusion, various methods of blood conservation in orthopaedic surgery have been studied. The most appropriate solution, however, is to reduce the loss of blood during and after an operation. The present prospective, controlled, randomized study was designed to evaluate the hemostatic efficacy of the use of fibrin tissue adhesive in patients managed with total knee arthroplasty. Fifty-eight patients who were scheduled to have a total knee arthroplasty were randomly divided into two groups: a control group, in which the standard means of hemostasis were applied, and a treatment group, in which the standard means to control local bleeding were applied and a fibrin tissue adhesive was sprayed on the internal aspects of the operative field before skin closure. All operations were performed in a bloodless field with use of a pneumatic tourniquet. All patients received low-molecular-weight heparin as thromboprophylaxis twelve hours before the operation and every twelve hours postoperatively. Blood loss during the operation was evaluated by measuring the volume in the suction apparatus and by estimating the amount of lost blood in the swabs at the end of the operation. The apparent postoperative lost blood was determined by measuring the volume in the suction-drain bottles. All blood transfusions were recorded. The mean apparent postoperative blood loss (and standard deviation) in the fibrin-tissue-adhesive group was 360+/-287.7 milliliters compared with 878+/-403.0 milliliters in the control group, with a mean difference of 518 milliliters (p<0.001). The decrease in the level of hemoglobin was 25+/-10 grams per liter in the treatment group compared with 37+/-12 grams per liter in the control group (p<0.001). Sixteen patients (55 percent) in the control group required a blood transfusion and eight (28 percent) required two units of blood, whereas only five (17 percent) of the patients in the fibrin-tissue-adhesive group required a blood transfusion and only one (3 percent) required two units (p = 0.004). The number of adverse events was comparable between the two groups. None of the adverse events were considered to be related to the use of fibrin tissue adhesive. One death, which was due to massive pulmonary embolism, was reported in the control group. No seroconversion was reported at three and six months after the operation. The use of fibrin tissue adhesive in total knee arthroplasty seems to be an effective and safe means with which to reduce blood loss and blood-transfusion requirements. Furthermore, the importance of these findings was enhanced by a significant reduction in blood loss, in the postoperative decrease in the level of hemoglobin, and in blood-transfusion requirements despite preoperative thromboprophylaxis with low-molecular-weight heparin.

Promoting employee health by integrating health protection, health promotion, and continuous improvement: a longitudinal quasi-experimental intervention study.

PubMed

von Thiele Schwarz, Ulrica; Augustsson, Hanna; Hasson, Henna; Stenfors-Hayes, Terese

2015-02-01

To test the effects of integrating health protection and health promotion with a continuous improvement system (Kaizen) on proximal employee outcomes (health promotion, integration, and Kaizen) and distal outcomes (workability, productivity, self-rated health and self-rated sickness absence). Twelve units in a county hospital in Sweden were randomized to control or intervention groups using a quasiexperimental study design. All staff (approximately 500) provided self-ratings in questionnaires at baseline, and a 12- and 24-month follow-up (response rate, 79% to 87.5%). There was a significant increase in the proximal outcomes over time in the intervention group compared with the control group, and a trend toward improvement in the distal outcomes workability and productivity. Integration seems to promote staff engagement in health protection and promotion, as well as to improve their understanding of the link between work and health.

Effect of a 6-Week Active Play Intervention on Fundamental Movement Skill Competence of Preschool Children.

PubMed

Foulkes, J D; Knowles, Z; Fairclough, S J; Stratton, G; O'Dwyer, M; Ridgers, N D; Foweather, L

2017-04-01

This study examined the effectiveness of an active play intervention on fundamental movement skills of 3- to 5-year-old children from deprived communities. In a cluster randomized controlled trial design, six preschools received a resource pack and a 6-week local authority program involving staff training with help implementing 60-minute weekly sessions and postprogram support. Six comparison preschools received a resource pack only. Twelve skills were assessed at baseline, postintervention, and at a 6-month follow-up using the Children's Activity and Movement in Preschool Study Motor Skills Protocol. One hundred and sixty-two children (Mean age = 4.64 ± 0.58 years; 53.1% boys) were included in the final analyses. There were no significant differences between groups for total fundamental movement skill, object-control skill or locomotor skill scores, indicating a need for program modification to facilitate greater skill improvements.

Communication technologies to improve HPV vaccination initiation and completion: A systematic review.

PubMed

Francis, Diane B; Cates, Joan R; Wagner, Kyla P Garrett; Zola, Tracey; Fitter, Jenny E; Coyne-Beasley, Tamera

2017-07-01

This systematic review examines the effectiveness of communication technology interventions on HPV vaccination initiation and completion. A comprehensive search strategy was used to identify existing randomized controlled trials testing the impact of computer-, mobile- or internet-based interventions on receipt of any dose of the HPV vaccine. Twelve relevant studies were identified with a total of 38,945 participants. The interventions were delivered using several different methods, including electronic health record (i.e. recall/reminder) prompts, text messaging, automated phone calls, interactive computer videos, and email. Vaccine initiation and completion was greater for technology-based studies relative to their control conditions. There is evidence that interventions utilizing communication technologies as their sole or primary mode for HPV vaccination intervention delivery may increase vaccination coverage. Communication technologies hold much promise for the future of HPV vaccination efforts, especially initiatives in practice-based settings. Copyright © 2017 Elsevier B.V. All rights reserved.

Computer programs and documentation

NASA Technical Reports Server (NTRS)

Speed, F. M.; Broadwater, S. L.

1971-01-01

Various statistical tests that were used to check out random number generators are described. A total of twelve different tests were considered, and from these, six were chosen to be used. The frequency test, max t test, run test, lag product test, gap test, and the matrix test are included.

Effect of Terbinafine on Theophylline Pharmacokinetics in Healthy Volunteers

PubMed Central

Trépanier, Eric F.; Nafziger, Anne N.; Amsden, Guy W.

1998-01-01

Twelve healthy volunteers were enrolled in an open-label, randomized, crossover study. Subjects received single doses of theophylline (5 mg/kg) with and without multiple-dose terbinafine, and 11 blood samples were collected over 24 h. The study phases were separated by a 4-week washout period. Theophylline serum data were modeled via noncompartmental analysis. When the control phase (i.e., no terbinafine) was compared to the treatment phase (terbinafine), theophylline exposure (the area under the serum concentration-time curve from time zero to infinity) increased by 16% (P = 0.03), oral clearance decreased by 14% (P = 0.04), and half-life increased by 24% (P = 0.002). No significant changes in other theophylline pharmacokinetic parameters were evident. PMID:9517954

Differences by gender at twelve months in a brief intervention trial among Mexican-origin young adults in the emergency department.

PubMed

Bernstein, Judith; Bernstein, Edward; Hudson, Dantia; Belanoff, Candice; Cabral, Howard J; Cherpitel, Cheryl J; Bond, Jason; Ye, Yu; Woolard, Robert; Villalobos, Susana; Ramos, Rebeca

2017-01-01

In this study, we investigate the role of gender in prevalence and consequences of binge drinking and brief intervention outcomes among Mexican-origin young adults aged 18-30 years at the U.S.-Mexico border. We conducted a secondary analysis, stratified by gender, from a randomized controlled trial of a brief motivational intervention in a hospital emergency department. Intervention effects for males included reductions in drinking frequency, binge drinking, and alcohol-related consequences. For females the intervention was associated with reduction in drinking frequency and binge drinking but did not have a significant effect on alcohol-related consequences. Results suggest a new direction for tailoring interventions to gender.

Effect of biotin supplementation on claw horn growth in young, clinically healthy cattle

PubMed Central

da Silva, Luiz Antônio Franco; Franco, Leandro Guimarães; Atayde, Ingrid Bueno; da Cunha, Paulo Henrique Jorge; de Moura, Maria Ivete; Goulart, Daniel Silva

2010-01-01

The effects of orally administered biotin supplementation on the growth of claw horn in young, clinically healthy cattle were analyzed. Twelve, 1-year-old Girolando cattle were randomly assigned to receive either 12.5 mg of diluted powdered biotin (GI) or a control treatment (GII) for 40 consecutive days. Cattle in the GI group showed an average hoof growth of 11.3 ± 0.72 mm, while those in GII had an average hoof growth of 7.2 ± 0.78 mm. The results confirmed the positive effect of biotin supplementation on the growth of angle and length of the dorsal hoof wall, hoof sole length, and on resistance to wearing, in young cattle extensively managed. PMID:20808571

The Effect of a Patient-Provider Educational Intervention to Reduce At-Risk Drinking on Changes in Health and Health-Related Quality of Life among Older Adults: The Project SHARE Study

PubMed Central

Barnes, Andrew J.; Xu, Haiyong; Tseng, Chi-Hong; Ang, Alfonso; Tallen, Louise; Moore, Alison A.; Marshall, Deborah C.; Mirkin, Michelle; Ransohoff, Kurt; Duru, O. Kenrik; Ettner, Susan L.

2015-01-01

Background At-risk drinking, defined as alcohol use that is excessive or potentially harmful in combination with select comorbidities or medications, affects about 10% of older adults in the United States and is associated with higher mortality. The Project SHARE intervention, which uses patient and provider educational materials, physician counseling, and health educator support, was designed to reduce at-risk drinking among this vulnerable population. Although an earlier study showed that this intervention was successful in reducing rates of at-risk drinking, it is unknown whether these reductions translate into improved health and health-related quality of life (HRQL). Objective To examine changes in health and HRQL of older adult at-risk drinkers resulting from a patient-provider educational intervention. Research Design A randomized controlled trial to compare the health and HRQL outcomes of patients assigned to the Project SHARE intervention vs. care as usual at baseline, six- and twelve-months post assignment. Control patients received usual care, which may or may not have included alcohol counseling. Intervention group patients received a personalized Patient Report, educational materials on alcohol and aging, a brief provider intervention, and a telephone health educator intervention. Subjects Current drinkers age 60 years and older accessing primary care clinics around Santa Barbara, California (n=1,049). Measurements Data were collected from patients using baseline, six- and twelve-month mail surveys. Health and HRQL measures included mental and physical component scores (MCS and PCS) based on the Short Form-12v2 (SF-12v2), the SF-6D, which is also based on the SF-12, and the Geriatric Depression Scale (GDS). Adjusted associations of treatment assignment with these outcomes were estimated using generalized least squares regressions with random provider effects. Regressions controlled for age group, sex, race/ethnicity, marital status, education, household income, home ownership and the baseline value of the dependent variable. Results After regression adjustment, the intervention was associated with a 0.58 point (95% CI: −0.06, 1.21) increase in 6-month MCS and a 0.14 point (95% CI: 0.01, 0.26) improvement in 12-month GDS score, compared to the control group. The intervention also increased adjusted SF-6D scores by 0.01 points at both six and twelve months (6-month 95% CI: 0.01, 0.02; 12-month 95% CI: 0.01, 0.01). Conclusions Despite the previously shown effectiveness of the Project SHARE intervention to reduce at-risk drinking among older adults, this effect translated into effects on health and HRQL that were statistically but not necessarily clinically significant. Effects were most prominent for patients who received physician discussions, suggesting that provider counseling may be a critical component of primary care-based interventions targeting at-risk alcohol use. PMID:26254687

Ayurvedic versus conventional dietary and lifestyle counseling for mothers with burnout-syndrome: A randomized controlled pilot study including a qualitative evaluation.

PubMed

Kessler, Christian S; Eisenmann, Clemens; Oberzaucher, Frank; Forster, Martin; Steckhan, Nico; Meier, Larissa; Stapelfeldt, Elmar; Michalsen, Andreas; Jeitler, Michael

2017-10-01

Ayurveda claims to be effective in the treatment of psychosomatic disorders by means of lifestyle and nutritional counseling. In a randomized controlled study mothers with burnout were randomized into two groups: Ayurvedic nutritional counseling (according to tradition), and conventional nutritional counseling (following the recommendations of a family doctor). Patients received five counseling sessions over twelve weeks. Outcomes included levels of burnout, quality of life, sleep, stress, depression/anxiety, and spirituality at three and six months. It also included a qualitative evaluation of the communication processes. We randomized thirty four patients; twenty three participants were included in the per protocol analysis. No significant differences were observed between the groups. However, significant and clinically relevant intra-group mean changes for the primary outcome burnout, and secondary outcomes sleep, stress, depression and mental health were only found in the Ayurveda group. The qualitative part of the study identified different conversational styles and counseling techniques between the two study groups. In conventional consultations questions tended to be category bound, while counseling-advice was predominantly admonitory. The Ayurvedic practitioner used open-ended interrogative forms, devices for displaying understanding, and positive re-evaluation more frequently, leading to an overall less asymmetrical interaction. We found positive effects for both groups, which however were more pronounced in the Ayurvedic group. The conversational and counseling techniques in the Ayurvedic group offered more opportunities for problem description by patients as well as patient-centered practice and resource-oriented recommendations by the physician. NCT01797887. Copyright © 2017 Elsevier Ltd. All rights reserved.

Controlling Chronic Diseases Through Evidence-Based Decision Making: A Group-Randomized Trial.

PubMed

Brownson, Ross C; Allen, Peg; Jacob, Rebekah R; deRuyter, Anna; Lakshman, Meenakshi; Reis, Rodrigo S; Yan, Yan

2017-11-30

Although practitioners in state health departments are ideally positioned to implement evidence-based interventions, few studies have examined how to build their capacity to do so. The objective of this study was to explore how to increase the use of evidence-based decision-making processes at both the individual and organization levels. We conducted a 2-arm, group-randomized trial with baseline data collection and follow-up at 18 to 24 months. Twelve state health departments were paired and randomly assigned to intervention or control condition. In the 6 intervention states, a multiday training on evidence-based decision making was conducted from March 2014 through March 2015 along with a set of supplemental capacity-building activities. Individual-level outcomes were evidence-based decision making skills of public health practitioners; organization-level outcomes were access to research evidence and participatory decision making. Mixed analysis of covariance models was used to evaluate the intervention effect by accounting for the cluster randomized trial design. Analysis was performed from March through May 2017. Participation 18 to 24 months after initial training was 73.5%. In mixed models adjusted for participant and state characteristics, the intervention group improved significantly in the overall skill gap (P = .01) and in 6 skill areas. Among the 4 organizational variables, only access to evidence and skilled staff showed an intervention effect (P = .04). Tailored and active strategies are needed to build capacity at the individual and organization levels for evidence-based decision making. Our study suggests several dissemination interventions for consideration by leaders seeking to improve public health practice.

Beneficial effects of an investigational wristband containing Synsepalum dulcificum (miracle fruit) seed oil on the performance of hand and finger motor skills in healthy subjects: A randomized controlled preliminary study.

PubMed

Gorin, Steven; Wakeford, Charles; Zhang, Guodong; Sukamtoh, Elvira; Matteliano, Charles Joseph; Finch, Alfred Earl

2018-02-01

Miracle fruit (Synsepalum dulcificum) seed oil (MFSO) contains phytochemicals and nutrients reported to affect musculoskeletal performance. The purpose of this study was to assess the safety and efficacy of a compression wristband containing MFSO on its ability to measurably improve the hand and finger motor skills of participants. Healthy right-handed participants (n = 38) were randomized in this double-blind, placebo-controlled study of MFSO and vehicle wristbands. Subjects wore the wristband on their left hand 4-6 weeks and then only on their right hand 2-4 weeks; the contralateral untreated hand served as an additional control. Twelve hand/finger motor skills were measured using quantitative bio-instrumentation tests, and subject self-assessment questionnaires were conducted. With each hand, in 9/12 tests, the MFSO group showed a clinically meaningful average improvement compared with an average worsening in the vehicle group. Statistical superiority to the control treatment group was exhibited in 9/12 tests for each hand (p < .01). After discontinuing the MFSO wristband on the left hand, test values regressed toward baseline levels. Subjects favored the MFSO wristband over the control, rating it as effective in improving their motor skills. Use of the MFSO wristband may improve an individual's manual dexterity skills and ability to maintain this performance. Copyright © 2017 The Authors Phytotherapy Research Published by John Wiley & Sons Ltd.

[Clinical research of EDTA pretreatment on the bonding strength of resin].

PubMed

Li, Ting-ting; Sun, Min-min; Kang, Jun-tang; Sun, Zhe

2015-10-01

This study was to evaluate clinical results of adhesives to sclerotic dentin in non-carious cervical lesions pretreated with ethylene diamine tetraacetic acid (EDTA). Twelve patients who had at least one pair of teeth with typical cervical wedge-shaped defects and class III sclerotic dentin were selected. The teeth were randomly divided into experimental and control groups. In the experimental group, EDTA was used to pretreat dentin surface first and then self-etching resin adhesive; In the control group, only self-etching resin adhesive was used. Modified USPHS rating system was applied in baseline, 6 months and 12 months after treatment. SAS 8.02 software package was used for two-sample rank sum test. At the time point of 6-month and 12-month, the scores in the experimental group were significantly better than the control group (P<0.05). EDTA pretreatment of the sclerotic dentin of cervical wedge-shaped defects could improve the resin bonding strength, marginal discoloration, marginal form and surface quality.

Tannins from Potentilla officinalis display antiinflammatory effects in the UV erythema test and on atopic skin.

PubMed

Hoffmann, Julia; Wölfle, Ute; Schempp, Christoph M; Casetti, Federica

2016-09-01

Rich in tannins, the rhizome of Potentilla officinalis (PO) has traditionally been used in the topical treatment of inflammatory disorders of the skin and mucous membranes. The objective of the present study was to examine the antiinflammatory effects of PO in the UV erythema test as well as in patients with atopic skin. Using the UV erythema test, the antiinflammatory effects of a PO extract (2 %) - compared to 1 % hydrocortisone acetate - were assessed in a randomized, prospective, placebo-controlled double-blind study of 40 healthy volunteers. In the context of a prospective non-controlled trial, the efficacy and tolerability of 2 % PO cream (applied to defined test areas twice daily for two weeks) was evaluated in twelve adults and twelve children with atopic skin using a partial SCORAD. In addition, the effects on the degree of erythema in the test areas was measured photometrically. In the UV erythema test, PO cream significantly reduced the erythema index compared to the vehicle. The antiinflammatory effects of PO cream were comparable to those of 1 % hydrocortisone acetate cream. The clinical study with atopic patients revealed a significant reduction in the partial SCORAD as well as erythema in the test areas. No adverse events were recorded. PO cream displays antiinflammatory effects in vivo. It is effective in and well tolerated by patients with atopic skin. © 2016 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd.

Efficacy and safety of Suanzaoren decoction for primary insomnia: a systematic review of randomized controlled trials

PubMed Central

2013-01-01

Background Insomnia is a widespread human health problem, but there currently are the limitations of conventional therapies available. Suanzaoren decoction (SZRD) is a well known classic Chinese herbal prescription for insomnia and has been treating people’s insomnia for more than thousand years. The objective of this study was to evaluate the efficacy and safety of SZRD for insomnia. Methods A systematic literature search was performed for 6 databases up to July of 2012 to identify randomized control trials (RCTs) involving SZRD for insomniac patients. The methodological quality of RCTs was assessed independently using the Cochrane Handbook for Systematic Reviews of Interventions. Results Twelve RCTs with total of 1376 adult participants were identified. The methodological quality of all included trials are no more than 3/8 score. Majority of the RCTs concluded that SZRD was more significantly effective than benzodiazepines for treating insomnia. Despite these positive outcomes, there were many methodological shortcomings in the studies reviewed, including insufficient information about randomization generation and absence of allocation concealment, lack of blinding and no placebo control, absence of intention-to-treat analysis and lack of follow-ups, selective publishing and reporting, and small number of sample sizes. A number of clinical heterogeneity such as diagnosis, intervention, control, and outcome measures were also reviewed. Only 3 trials reported adverse events, whereas the other 9 trials did not provide the safety information. Conclusions Despite the apparent reported positive findings, there is insufficient evidence to support efficacy of SZRD for insomnia due to the poor methodological quality and the small number of trials of the included studies. SZRD seems generally safe, but is insufficient evidence to make conclusions on the safety because fewer studies reported the adverse events. Further large sample-size and well-designed RCTs are needed. PMID:23336848

Cultural competence education for health professionals from pre-graduation to licensure delivered using facebook: Twelve-month follow-up on a randomized control trial.

PubMed

Chang, Li-Chun; Guo, Jong Long; Lin, Hui-Ling

2017-12-01

Cultural competence (CC) training is widely recognized as a crucial component of the professional development of healthcare providers. There is no study on the effect of Facebook (FB) as a strategy to promote continual learning to enhance CC among students in health professions. To test the effects of cultural competence education using FB as a delivery platform on knowledge, awareness, self-efficacy, and skill related to CC in health students from pre-graduation to licensed professional stages. A randomized controlled trial. We recruited students from professional nursing, pharmacy, and nutrition programs at six medical universities and randomly assigned them to study groups. Between T1 and T2 (months 1-3), the intervention group (IG) received pre-graduation education in CC while the control group (CG) received their regular educational program. Between T2 and T3 (months 6-9), IG received on-the-job education in CC while CG received the regular program. An online self-report questionnaire assessing CC knowledge, awareness, self-efficacy, and skill was analyzed at baseline, 6months, and 12months. Of 180 participants who completed the pretest, 120 (65 IG and 55 CG) completed both follow-ups. Changes over time were mixed; the only statistical difference between groups was an improvement in awareness in IG but not in CG. At 12months, intervention and control participants had different levels of awareness of CC (β=2.56, p<0.001), but other outcomes did not differ between groups. Health profession educators can adopt Facebook as an education delivery platform to offer personalized, social learning incorporating cultural competency curricula into ongoing education and training in rising awareness on CC. Copyright © 2017 Elsevier Ltd. All rights reserved.

Comparison of oral oxycodone and naproxen in soft tissue injury pain control: a double-blind randomized clinical trial.

PubMed

Fathi, Marzieh; Zare, Mohammad Amin; Bahmani, Hamid Reza; Zehtabchi, Shahriar

2015-09-01

This randomized clinical trial compares the efficacy and safety of oral oxycodone (an oral opioid) with naproxen (a nonsteroidal anti-inflammatory drug) in acute pain control in patients with soft tissue injury. It also evaluates the need for additional doses of analgesics in the first 24 hours of discharge from emergency department (ED). Adult (>18 years old) patients with soft tissue injuries were enrolled in a teaching urban ED. Subjects were randomly allocated to receive a single dose of oral oxycodone (5 mg) or oral naproxen (250 mg). Pain scores and drugs' adverse effects were assessed before, 30 minutes, and 60 minutes after medication. efficacy in pain control (reduction in pain scale >2 points) and safety (rate of side effects). The need for additional pain medication after discharge was assessed by follow-up phone call 24 hours after discharge. A total of 150 patients were enrolled. Pain scores were similar in oxycodone vs naproxen groups before (6.21 ± 0.9 in vs 6.0 ± 1.0), 30 minutes (4.5 ± 1.4 vs 4.4 ± 1.2), and 60 minutes (2.5 ± 1.3 in vs 2.6 ± 1.3) after medication, respectively. Twelve (16.0%) patients in oral oxycodone group and 5 (6.6%) patients in naproxen group needed more analgesics in first 24 hours after ED discharge. Adverse effects were more common in oxycodone group (statistically significant difference). The most common adverse effects in oxycodone group were nausea, (13.3%); vomiting, (8.0%); dizziness, (5.3%); drowsiness, 3 (4.0%); and pruritis, (2.7%). Oral oxycodone is as effective as naproxen in soft tissue injury pain control but has a less favorable safety profile. Copyright © 2015 Elsevier Inc. All rights reserved.

Aquatic exercise and pain neurophysiology education versus aquatic exercise alone for patients with chronic low back pain: a randomized controlled trial.

PubMed

Pires, Diogo; Cruz, Eduardo Brazete; Caeiro, Carmen

2015-06-01

The aim of this study was to compare the effectiveness of a combination of aquatic exercise and pain neurophysiology education with aquatic exercise alone in chronic low back pain patients. Single-blind randomized controlled trial. Outpatient clinic. Sixty-two chronic low back pain patients were randomly allocated to receive aquatic exercise and pain neurophysiology education (n = 30) or aquatic exercise alone (n = 32). Twelve sessions of a 6-week aquatic exercise programme preceded by 2 sessions of pain neurophysiology education. Controls received only 12 sessions of the 6-week aquatic exercise programme. The primary outcomes were pain intensity (Visual Analogue Scale) and functional disability (Quebec Back Pain Disability Scale) at the baseline, 6 weeks after the beginning of the aquatic exercise programme and at the 3 months follow-up. Secondary outcome was kinesiophobia (Tampa Scale of Kinesiophobia). Fifty-five participants completed the study. Analysis using mixed-model ANOVA revealed a significant treatment condition interaction on pain intensity at the 3 months follow-up, favoring the education group (mean SD change: -25.4± 26.7 vs -6.6 ± 30.7, P < 0.005). Although participants in the education group were more likely to report perceived functional benefits from treatment at 3 months follow-up (RR=1.63, 95%CI: 1.01-2.63), no significant differences were found in functional disability and kinesiophobia between groups at any time. This study's findings support the provision of pain neurophysiology education as a clinically effective addition to aquatic exercise. © The Author(s) 2014.

Effects of psychological interventions for patients with osteoarthritis: a systematic review and meta-analysis.

PubMed

Zhang, Lijuan; Fu, Ting; Zhang, Qiuxiang; Yin, Rulan; Zhu, Li; He, Yan; Fu, Wenting; Shen, Biyu

2018-01-01

The aim of this study was to determine the effects of psychological interventions (e.g. cognitive restructuring, relaxation) on physiological and psychological health in osteoarthritis patients. A systematic literature search was done using PubMed, Embase, PsycINFO, Web of Science, China National Knowledge Infrastructure, and Wanfang Database through November 2016. Studies were included if they used a randomized controlled trial designed to explore the effects of psychological interventions in osteoarthritis patients. Two independent authors assessed the methodological quality of the trials using criteria outlined by Jadad et al. Meta-analysis was done with the Revman5.0. Twelve randomized controlled trials, including 1307 osteoarthritis patients, met the study inclusion criteria. Meta-analysis showed that psychological interventions could reduce the levels of pain [standard mean difference (SMD) -0.28, 95% CI -0.48, -0.08, P-value 0.005)] and fatigue (SMD -0.18, 95% CI -0.34, -0.01, P-value 0.04). In addition, psychological interventions significantly improved osteoarthritis patients' self-efficacy (SMD 0.58, 95% CI 0.40, 0.75, P-value 0.00) and pain coping (MD 1.64, 95% CI 0.03, 3.25, P-value 0.05). Although the effects on physical function, anxiety, depression, psychological disability were in the expected direction, they were not statistically significant. In conclusion, the role of psychological interventions in the management of osteoarthritis remains equivocal. Some encouraging results were seen with regard to pain, pain coping, self-efficacy, and fatigue. We believe that more methodologically rigorous large-scale randomized controlled trials are necessary to answer this study question.

The effects of augmented visual feedback during balance training in Parkinson's disease: study design of a randomized clinical trial.

PubMed

van den Heuvel, Maarten R C; van Wegen, Erwin E H; de Goede, Cees J T; Burgers-Bots, Ingrid A L; Beek, Peter J; Daffertshofer, Andreas; Kwakkel, Gert

2013-10-04

Patients with Parkinson's disease often suffer from reduced mobility due to impaired postural control. Balance exercises form an integral part of rehabilitative therapy but the effectiveness of existing interventions is limited. Recent technological advances allow for providing enhanced visual feedback in the context of computer games, which provide an attractive alternative to conventional therapy. The objective of this randomized clinical trial is to investigate whether a training program capitalizing on virtual-reality-based visual feedback is more effective than an equally-dosed conventional training in improving standing balance performance in patients with Parkinson's disease. Patients with idiopathic Parkinson's disease will participate in a five-week balance training program comprising ten treatment sessions of 60 minutes each. Participants will be randomly allocated to (1) an experimental group that will receive balance training using augmented visual feedback, or (2) a control group that will receive balance training in accordance with current physical therapy guidelines for Parkinson's disease patients. Training sessions consist of task-specific exercises that are organized as a series of workstations. Assessments will take place before training, at six weeks, and at twelve weeks follow-up. The functional reach test will serve as the primary outcome measure supplemented by comprehensive assessments of functional balance, posturography, and electroencephalography. We hypothesize that balance training based on visual feedback will show greater improvements on standing balance performance than conventional balance training. In addition, we expect that learning new control strategies will be visible in the co-registered posturographic recordings but also through changes in functional connectivity.

Rifaximin vs conventional oral therapy for hepatic encephalopathy: A meta-analysis

PubMed Central

Eltawil, Karim M; Laryea, Marie; Peltekian, Kevork; Molinari, Michele

2012-01-01

AIM: To characterize the efficacy of rifaximin in the management of hepatic encephalopathy (HE) as several randomized controlled studies have shown contradictory results on its effectiveness in comparison to other oral agents. METHODS: We performed a systematic review and random effects meta-analysis of all eligible trials identified through electronic and manual searches. Twelve randomized controlled trials met the inclusion criteria with a total of 565 patients. RESULTS: The clinical effectiveness of rifaximin was equivalent to disaccharides or other oral antibiotics [odds ratio (OR) 0.96; 95% CI: 0.94-4.08] but with a better safety profile (OR 0.27; 95% CI: 0.12-0.59). At the completion of treatment protocols, patients receiving rifaximin showed lower serum ammonia levels [weighted mean difference (WMD) = -10.65; 95% CI: -23.4-2.1; P = 0.10], better mental status (WMD = -0.24; 95% CI: -0.57-0.08; P = 0.15) and less asterixis (WMD -0.1; 95% CI -0.26-0.07; P = 0.25) without reaching statistical significance. On the other hand, other psychometric outcomes such as electroencephalographic response and grades of portosystemic encephalopathy were superior in patients treated with rifaximin in comparison to the control group (WMD = 0.21, 95% CI: -0.33-0.09, P = 0.0004; and WMD = -2.33, 95% CI: -2.68-1.98, P = 0.00001, respectively). Subgroup and sensitivity analysis did not show any significant difference in the above findings. CONCLUSION: Rifaximin appears to be at least as effective as other conventional oral agents for the treatment of HE with a better safety profile. PMID:22371636

Prolonged conservative treatment or 'early' surgery in sciatica caused by a lumbar disc herniation: rationale and design of a randomized trial [ISRCT 26872154

PubMed Central

Peul, Wilco C; van Houwelingen, Hans C; van der Hout, Wilbert B; Brand, Ronald; Eekhof, Just AH; Tans, Joseph ThJ; Thomeer, Ralph TWM; Koes, Bart W

2005-01-01

Background The design of a randomized multicenter trial is presented on the effectiveness of a prolonged conservative treatment strategy compared with surgery in patients with persisting intense sciatica (lumbosacral radicular syndrome). Methods/design Patients presenting themselves to their general practitioner with disabling sciatica lasting less than twelve weeks are referred to the neurology outpatient department of one of the participating hospitals. After confirmation of the diagnosis and surgical indication MRI scanning is performed. If a distinct disc herniation is discerned which in addition covers the clinically expected site the patient is eligible for randomization. Depending on the outcome of the randomization scheme the patient will either be submitted to prolonged conservative care or surgery. Surgery will be carried out according to the guidelines and between six and twelve weeks after onset of complaints. The experimental therapy consists of a prolonged conservative treatment under supervision of the general practitioner, which may be followed by surgical intervention in case of persisting or progressive disability. The main primary outcome measure is the disease specific disability of daily functioning. Other primary outcome measures are perceived recovery and intensity of legpain. Secondary outcome measures encompass severity of complaints, quality of life, medical consumption, absenteeism, costs and preference. The main research question will be answered at 12 months after randomization. The total follow-up period covers two years. Discussion Evidence is lacking concerning the optimal treatment of lumbar disc induced sciatica. This pragmatic randomized trial, focusses on the 'timing' of intervention, and will contribute to the decision of the general practictioner and neurologist, regarding referral of patients for surgery. PMID:15707491

Unannounced versus announced hospital surveys: a nationwide cluster-randomized controlled trial.

PubMed

Ehlers, Lars Holger; Simonsen, Katherina Beltoft; Jensen, Morten Berg; Rasmussen, Gitte Sand; Olesen, Anne Vingaard

2017-06-01

To evaluate the effectiveness of unannounced versus announced surveys in detecting non-compliance with accreditation standards in public hospitals. A nationwide cluster-randomized controlled trial. All public hospitals in Denmark were invited. Twenty-three hospitals (77%) (3 university hospitals, 5 psychiatric hospitals and 15 general hospitals) agreed to participate. Twelve hospitals were randomized to receive unannounced surveys (intervention group) and eleven hospitals to receive announced surveys (control group). We hypothesized that the hospitals receiving the unannounced surveys would reveal a higher degree of non-compliance with accreditation standards than the hospitals receiving announced surveys. Nine surveyors trained and employed by the Danish Institute for Quality and Accreditation in Healthcare (IKAS) were randomized into teams and conducted all surveys. The outcome was the surveyors' assessment of the hospitals' level of compliance with 113 performance indicators-an abbreviated set of the Danish Healthcare Quality Programme (DDKM) version 2, covering organizational standards, patient pathway standards and patient safety standards. Compliance with performance indicators was analyzed using binomial regression analysis with bootstrapped robust standard errors. In all, 16 202 measurements were acceptable for data analysis. The risk of observing non-compliance with performance indicators for the intervention group compared with the control group was statistically insignificant (risk difference (RD) = -0.6 percentage points [-2.51-1.31], P = 0.54). A converged analysis of the six patient safety critical standards, requiring 100% compliance to gain accreditation status revealed no statistically significant difference (RD = -0.78 percentage points [-4.01-2.44], P = 0.99). Unannounced hospital surveys were not more effective than announced surveys in detecting quality problems in Danish hospitals. ClinicalTrials.gov NCT02348567, https://clinicaltrials.gov/ct2/show/NCT02348567?term=NCT02348567. © The Author 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care.

Tree species exhibit complex patterns of distribution in bottomland hardwood forests

Treesearch

Luben D Dimov; Jim L Chambers; Brian R. Lockhart

2013-01-01

& Context Understanding tree interactions requires an insight into their spatial distribution. & Aims We looked for presence and extent of tree intraspecific spatial point pattern (random, aggregated, or overdispersed) and interspecific spatial point pattern (independent, aggregated, or segregated). & Methods We established twelve 0.64-ha plots in natural...

Scenic Beauty in Summer the Year Before, the Year After, and 4 Years After Harvest

Treesearch

Victor A. Rudis; Hochan Jang; James H. Gramann

2004-01-01

Abstract - This study examined the effects of four silvicultural options (clearcut, group selection, shelterwood, and untreated) on the perceived scenic beauty of shortleaf pine-oak (Pinus echinata-Quercus spp.) stands of national forest land in the Ouachita Mountains of Arkansas. Twelve randomly selected stands...

Economic evaluation of an intervention program with the aim to improve at-work productivity for workers with rheumatoid arthritis.

PubMed

Noben, Cindy; Vilsteren, Myrthe van; Boot, Cécile; Steenbeek, Romy; Schaardenburg, Dirkjan van; Anema, Johannes R; Evers, Silvia; Nijhuis, Frans; Rijk, Angelique de

2017-05-25

Evaluating the cost effectiveness and cost utility of an integrated care intervention and participatory workplace intervention for workers with rheumatoid arthritis (RA) to improve their work productivity. Twelve month follow-up economic evaluation alongside a randomized controlled trial (RCT) within specialized rheumatology treatment centers. Adults diagnosed with RA between 18-64 years, in a paid job for at least eight hours per week, experiencing minor difficulties in work functioning were randomized to the intervention (n = 75) or the care-as-usual (CAU) group (n = 75). Effect outcomes were productivity and quality of life (QALYs). Costs associated with healthcare, patient and family, productivity, and intervention were calculated from a societal perspective. Cost effectiveness and cost utility were assessed to indicate the incremental costs and benefits per additional unit of effect. Subgroup and sensitivity analyses evaluated the robustness of the findings. At-work productivity loss was about 4.6 hours in the intervention group and 3.5 hours in the care as usual (CAU) group per two weeks. Differences in QALY were negligible; 0.77 for the CAU group and 0.74 for the intervention group. In total, average costs after twelve months follow-up were highest in the intervention group (€7,437.76) compared to the CAU group (€5,758.23). The cost-effectiveness and cost-utility analyses show that the intervention was less effective and (often) more expensive when compared to CAU. Sensitivity analyses supported these findings. The integrated care intervention and participatory workplace intervention for workers with RA provides gains neither in productivity at the workplace nor in quality of life. These results do not justify the additional costs.

Economic evaluation of an intervention program with the aim to improve at-work productivity for workers with rheumatoid arthritis

PubMed Central

Noben, Cindy; van Vilsteren, Myrthe; Boot, Cécile; Steenbeek, Romy; van Schaardenburg, Dirkjan; Anema, Johannes R.; Evers, Silvia; Nijhuis, Frans; de Rijk, Angelique

2017-01-01

Objectives: Evaluating the cost effectiveness and cost utility of an integrated care intervention and participatory workplace intervention for workers with rheumatoid arthritis (RA) to improve their work productivity. Methods: Twelve month follow-up economic evaluation alongside a randomized controlled trial (RCT) within specialized rheumatology treatment centers. Adults diagnosed with RA between 18-64 years, in a paid job for at least eight hours per week, experiencing minor difficulties in work functioning were randomized to the intervention (n = 75) or the care-as-usual (CAU) group (n = 75). Effect outcomes were productivity and quality of life (QALYs). Costs associated with healthcare, patient and family, productivity, and intervention were calculated from a societal perspective. Cost effectiveness and cost utility were assessed to indicate the incremental costs and benefits per additional unit of effect. Subgroup and sensitivity analyses evaluated the robustness of the findings. Results: At-work productivity loss was about 4.6 hours in the intervention group and 3.5 hours in the care as usual (CAU) group per two weeks. Differences in QALY were negligible; 0.77 for the CAU group and 0.74 for the intervention group. In total, average costs after twelve months follow-up were highest in the intervention group (€7,437.76) compared to the CAU group (€5,758.23). The cost-effectiveness and cost-utility analyses show that the intervention was less effective and (often) more expensive when compared to CAU. Sensitivity analyses supported these findings. Discussion: The integrated care intervention and participatory workplace intervention for workers with RA provides gains neither in productivity at the workplace nor in quality of life. These results do not justify the additional costs. PMID:28381814

Twelve Channel Optical Fiber Connector Assembly: From Commercial Off the Shelf to Space Flight Use

NASA Technical Reports Server (NTRS)

Ott, Melaine N.

1998-01-01

The commercial off the shelf (COTS) twelve channel optical fiber MTP array connector and ribbon cable assembly is being validated for space flight use and the results of this study to date are presented here. The interconnection system implemented for the Parallel Fiber Optic Data Bus (PFODB) physical layer will include a 100/140 micron diameter optical fiber in the cable configuration among other enhancements. As part of this investigation, the COTS 62.5/125 microns optical fiber cable assembly has been characterized for space environment performance as a baseline for improving the performance of the 100/140 micron diameter ribbon cable for the Parallel FODB application. Presented here are the testing and results of random vibration and thermal environmental characterization of this commercial off the shelf (COTS) MTP twelve channel ribbon cable assembly. This paper is the first in a series of papers which will characterize and document the performance of Parallel FODB's physical layer from COTS to space flight worthy.

Effectiveness of proactive telephone counselling for smoking cessation in parents: Study protocol of a randomized controlled trial

PubMed Central

2011-01-01

Background Smoking is the world's fourth most common risk factor for disease, the leading preventable cause of death, and it is associated with tremendous social costs. In the Netherlands, the smoking prevalence rate is high. A total of 27.7% of the population over age 15 years smokes. In addition to the direct advantages of smoking cessation for the smoker, parents who quit smoking may also decrease their children's risk of smoking initiation. Methods/Design A randomized controlled trial will be conducted to evaluate the effectiveness of proactive telephone counselling to increase smoking cessation rates among smoking parents. A total of 512 smoking parents will be proactively recruited through their children's primary schools and randomly assigned to either proactive telephone counselling or a control condition. Proactive telephone counselling will consist of up to seven counsellor-initiated telephone calls (based on cognitive-behavioural skill building and Motivational Interviewing), distributed over a period of three months. Three supplementary brochures will also be provided. In the control condition, parents will receive a standard brochure to aid smoking cessation. Assessments will take place at baseline, three months after start of the intervention (post-measurement), and twelve months after start of the intervention (follow-up measurement). Primary outcome measures will include sustained abstinence between post-measurement and follow-up measurement and 7-day point prevalence abstinence and 24-hours point prevalence abstinence at both post- and follow-up measurement. Several secondary outcome measures will also be included (e.g., smoking intensity, smoking policies at home). In addition, we will evaluate smoking-related cognitions (e.g., attitudes towards smoking, social norms, self-efficacy, intention to smoke) in 9-12 year old children of smoking parents. Discussion This study protocol describes the design of a randomized controlled trial to evaluate the effectiveness of proactive telephone counselling in smoking cessation. It is expected that, in the telephone counseling condition, parental smoking cessation rates will be higher and children's cognitions will be less favorable about smoking compared to the control condition. Trial registration The protocol for this study is registered with the Netherlands Trial Register NTR2707. PMID:21943207

Diet and lifestyle intervention among patients with colorectal adenomas: rationale and design of a Malaysian study.

PubMed

Kandiah, Mirnalini; Ramadas, Amutha; Shariff, Zalilah Mohd; Yusof, Rokiah Mohd; Gul, Yunus Gul Alif

2005-01-01

Comprehensive evaluation of the large body of consistent evidence from laboratory, epidemiologic and clinical studies has led to the conclusion that modification of the dietary and lifestyle patterns of populations has considerable potential for reducing cancer risk. This paper describes a randomized-controlled trial involving a diet and lifestyle intervention for patients with history of colorectal adenomas. The primary aim of this trial is to evaluate the effectiveness of the intervention with reference to recurrence of adenomatous polyps over a two year period--the first year being the intervention period and the second year of the study allowing for post-intervention follow-up. Subjects found to fit the inclusion criteria are recruited and randomized to two groups: the intervention group and the control group. The intervention group subjects will attend a monthly lecture-discussion session for 10 months and small group counseling on modification of lifestyle behavior and diet as well as receive educational materials which were adapted from the WCRF Diet and Health Recommendations for Cancer Prevention. Control subjects will be provided with the usual care given to such patients. One hundred and sixteen patients who were diagnosed with colorectal adenomatous polyps in the previous twelve months at the Hospital Kuala Lumpur have already been enrolled in this trial. Baseline data collection is on-going.

Prevention and Treatment of White Spot Lesions During and After Treatment with Fixed Orthodontic Appliances: a Systematic Literature Review.

PubMed

Lopatiene, Kristina; Borisovaite, Marija; Lapenaite, Egle

2016-01-01

The aim of the systematic literature review is to update the evidence for the prevention of white spot lesions, using materials containing fluoride and/or casein phosphopeptide-amorphous calcium phosphate during and after treatment with fixed orthodontic appliances. Information search for controlled studies on humans published between January 2008 and February 2016 was performed in PubMed, ScienceDirect, Embase, The Cochrane Library. Inclusion criteria were: the English language, study on humans, patients undergoing orthodontic treatment with fixed appliances, randomized or quasi-randomized controlled clinical studies fluoride-containing product or casein derivates used throughout the appliance therapy or straightaway after debonding. 326 articles were reviewed (Embase 141, PubMed 129, ScienceDirect 41, Cochrane 15). Twelve clinical studies fulfilled all inclusion criteria. Use of fluoridated toothpaste had a remineralizing effect on white spot lesions (WSLs) (P < 0.05); fluoride varnish and casein supplements were effective in prevention and early treatment of WSLs (P < 0.05). Early detection of white spot lesions during orthodontic treatment would allow implementing preventive measures to control the demineralization process before lesions progress. The systemic review has showed that the usage of fluoride and casein supplements in ameliorating white spot lesions during and after fixed orthodontic treatment is significantly effective. However the use of casein phosphopeptide-amorphous calcium phosphate can be more beneficial than fluoride rinse in the reduction of demineralization spots.

Can a new behaviorally oriented training process to improve lifting technique prevent occupationally related back injuries due to lifting?

PubMed

Lavender, Steven A; Lorenz, Eric P; Andersson, Gunnar B J

2007-02-15

A prospective randomized control trial. To determine the degree to which a new behavior-based lift training program (LiftTrainer; Ascension Technology, Burlington, VT) could reduce the incidence of low back disorder in distribution center jobs that require repetitive lifting. Most studies show programs aimed at training lifting techniques to be ineffective in preventing low back disorders, which may be due to their conceptual rather than behavioral learning approach. A total of 2144 employees in 19 distribution centers were randomized into either the LiftTrainer program or a video control group. In the LiftTrainer program, participants were individually trained in up to 5, 30-minute sessions while instrumented with motion capture sensors to quantify the L5/S1 moments. Twelve months following the initial training, injury data were obtained from company records. Survival analyses (Kaplan-Meier) indicated that there was no difference in injury rates between the 2 training groups. Likewise, there was no difference in the turnover rates. However, those with a low (<30 Nm) average twisting moment at the end of the first session experienced a significantly (P < 0.005) lower rate of low back disorder than controls. While overall the LiftTrainer program was not effective, those with twisting moments below 30 Nm reported fewer injuries, suggesting a shift in focus for "safe" lifting programs.

Cranberry (poly)phenol metabolites correlate with improvements in vascular function: A double-blind, randomized, controlled, dose-response, crossover study.

PubMed

Rodriguez-Mateos, Ana; Feliciano, Rodrigo P; Boeres, Albert; Weber, Timon; Dos Santos, Claudia Nunes; Ventura, M Rita; Heiss, Christian

2016-10-01

Cranberries are rich in potentially bioactive (poly)phenols. The aim of this paper was to investigate whether cranberry juice intake can improve vascular function in healthy men in a dose- and time-dependent manner, and to understand which of the circulating (poly)phenol metabolites correlate with vascular effects. A double-blind randomized controlled crossover trial was conducted in ten healthy males. Flow-mediated dilation (FMD), blood pressure, pulse wave velocity and augmentation index were investigated at baseline, 1, 2, 4, 6, and 8 h post-consumption of cranberry juices containing 409, 787, 1238, 1534, and 1910 mg of total cranberry (poly)phenols (TP), and a control drink. Plasma (poly)phenol metabolites were analyzed by UPLC-Q-TOF MS using authentic standards. We observed dose-dependent increases in FMD at 1, 2, 4, 6, and 8 h with a peak at 4 h and maximal effects with juice containing 1238 mg TP. A total of 60 metabolites were quantified in plasma after cranberry consumption. Twelve (poly)phenol metabolites significantly correlated with the increases in FMD, including ferulic and caffeic acid sulfates, quercetin-3-O-ß-D-glucuronide and a γ-valerolactone sulfate. (Poly)phenols in cranberry juice can improve vascular function in healthy males and this is linked to the presence of specific newly identified plasma metabolites. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

A comparative study of the effects of topical application of Aloe vera, thyroid hormone and silver sulfadiazine on skin wounds in Wistar rats

PubMed Central

Norouzian, Mohsen; Zarein-Dolab, Saeed; Dadpay, Masoomeh; Gazor, Roohollah

2012-01-01

Many research studies report the healing effects of Aloe Vera, thyroid hormone cream and silver sulfadiazine. However, the effects of these therapeutic agents are not well understood and have not been compared in one study. This study aimed at investigating the effects of topical application of an Aloe vera gel, a thyroid hormone cream and a silver sulfadiazine cream on the healing of skin wounds surgically induced in Wistar rats for determining the treatment of choice. In a randomized controlled trial, twelve male rats, aged 120 days and with a mean weight of 250 to 300 g, were divided randomly into 5 groups based on drug treatments: Aloe vera gel (AV), thyroid hormone cream (TC), silver sulfadiazine 1% (S), vehicle (V) and control. To evaluate the efficacy of each treatment technique, a biomechanical approach was used to assess tensile stress after 14 days of treatment. Tensile stress was significantly improved in the Aloe vera gel group as compared with the other four groups (P≤0.05). While the other treatment options resulted in better healing than the control group, this difference was not significant. We conclude that Aloe vera topical application accelerated the healing process more than thyroid hormone, silver sulfadiazine and vehicle in surgically induced incisions in rats. PMID:22474470

Does hippotherapy effect use of sensory information for balance in people with multiple sclerosis?

PubMed

Lindroth, Jodi L; Sullivan, Jessica L; Silkwood-Sherer, Debbie

2015-01-01

This case-series study aimed to determine if there were observable changes in sensory processing for postural control in individuals with multiple sclerosis (MS) following physical therapy using hippotherapy (HPOT), or changes in balance and functional gait. This pre-test non-randomized design study, with follow-up assessment at 6 weeks, included two females and one male (age range 37-60 years) with diagnoses of relapse-remitting or progressive MS. The intervention consisted of twelve 40-min physical therapy sessions which included HPOT twice a week for 6 weeks. Sensory organization and balance were assessed by the Sensory Organization Test (SOT) and Berg Balance Scale (BBS). Gait was assessed using the Functional Gait Assessment (FGA). Following the intervention period, all three participants showed improvements in SOT (range 1-8 points), BBS (range 2-6 points), and FGA (average 4 points) scores. These improvements were maintained or continued to improve at follow-up assessment. Two of the three participants no longer over-relied on vision and/or somatosensory information as the primary sensory input for postural control, suggesting improved use of sensory information for balance. The results indicate that HPOT may be a beneficial physical therapy treatment strategy to improve balance, functional gait, and enhance how some individuals with MS process sensory cues for postural control. Randomized clinical trials will be necessary to validate results of this study.

Effect of Lycopene Supplementation on Oxidative Stress: An Exploratory Systematic Review and Meta-Analysis of Randomized Controlled Trials

PubMed Central

Chen, Jinyao; Song, Yang

2013-01-01

Abstract Lycopene is a potentially useful compound for preventing and treating cardiovascular diseases and cancers. Studies on the effects of lycopene on oxidative stress offer insights into its mechanism of action and provide evidence-based rationale for its supplementation. In this analysis, randomized controlled trials of the effects of oral lycopene supplementation on any valid outcomes of oxidative stress were identified and pooled through a search of international journal databases and reference lists of relevant publications. Two reviewers extracted data from each of the identified studies. Only studies of sufficient quality were included. Twelve parallel trials and one crossover trial were included in the systematic review, and six trials provided data for quantitative meta-analysis. Our results indicate that lycopene supplementation significantly decreases the DNA tail length, as determined using comet assays, with a mean difference (MD) of −6.27 [95% confidence interval (CI) −10.74, −1.90] (P=.006) between the lycopene intervention groups and the control groups. Lycopene supplementation does not significantly prolong the lag time of low-density lipoprotein (MD 3.76 [95% CI −2.48, 10.01]; P=.24). Lycopene possibly alleviates oxidative stress; however, biomarker research for oxidative stress needs be more consistent with the outcomes in lycopene intervention trials for disease prevention. PMID:23631493

The impact of sarcopenia on a physical activity intervention: the Lifestyle Interventions and Independence for Elders Pilot Study (LIFE-P).

PubMed

Liu, C K; Leng, X; Hsu, F-C; Kritchevsky, S B; Ding, J; Earnest, C P; Ferrucci, L; Goodpaster, B H; Guralnik, J M; Lenchik, L; Pahor, M; Fielding, R A

2014-01-01

To determine if sarcopenia modulates the response to a physical activity intervention in functionally limited older adults. Secondary analysis of a randomized controlled trial. Three academic centers. Elders aged 70 to 89 years at risk for mobility disability who underwent dual-energy x-ray absorptiometry (DXA) for body composition at enrollment and follow-up at twelve months (N = 177). Subjects participated in a physical activity program (PA) featuring aerobic, strength, balance, and flexibility training, or a successful aging (SA) educational program about healthy aging. Sarcopenia as determined by measuring appendicular lean mass and adjusting for height and total body fat mass (residuals method), Short Physical Performance Battery score (SPPB), and gait speed determined on 400 meter course. At twelve months, sarcopenic and non-sarcopenic subjects in PA tended to have higher mean SPPB scores (8.7±0.5 and 8.7±0.2 points) compared to sarcopenic and non-sarcopenic subjects in SA (8.3±0.5 and 8.4±0.2 points, p = 0.24 and 0.10), although the differences were not statistically significant. At twelve months, faster mean gait speeds were observed in PA: 0.93±0.4 and 0.95±0.03 meters/second in sarcopenic and non-sarcopenic PA subjects, and 0.89±0.4 and 0.91±0.03 meters/second in sarcopenic and non-sarcopenic SA subjects (p = 0.98 and 0.26), although not statistically significant. There was no difference between the sarcopenic and non-sarcopenic groups in intervention adherence or number of adverse events. These data suggest that older adults with sarcopenia, who represent a vulnerable segment of the elder population, are capable of improvements in physical performance after a physical activity intervention.

A research on the effects of practicing Baduanjin on the lower extremities by using sEMG

NASA Astrophysics Data System (ADS)

Jin, Li; Li, Ran; Chen, Jing; Tian, Ye

2015-03-01

The purpose of this study was to evaluate the effects of practicing Baduanjin exercises on the lower extremities of subjects, using electromyography analysis, and values of IEMG were calculated. [Subjects] Forty, healthy adults were randomly assigned as subjects to two groups: SG (Study Group, n=20) who received twelve weeks of Baduanjin training, and CG (Control Group, n=20), who received no training. [Methods] A sixteen-channel sEMG system (ME6000, Mega Electronics Ltd., Kuopio, Finland) was selected to record and measure activity changes in two muscles (vastus medialis and vastus lateralis). [Results] After twelve-week of Baduanjin training, the results of this study showed that the SG group had significant increases in values of IEMG in second, fifth and seventh section of the Baduanjin exercises. In second section, the values of IEMG had increased for 56.95% in vastus lateralis (p < 0.05) and for 40.04% in vastus medialis (p < 0.05). In fifth section, the values of IEMG had increased for 37.61% in vastus lateralis (p < 0.05) and for 33.83% in vastus medialis (p < 0.05). In seventh section, the increasement of IEMG values was 47.19% in vastus lateralis (p < 0.05) and 49.31% in vastus medialis (p < 0.05). [Conclusion] This study indicated that performing twelve-week of Baduanjin training can significantly increase the strength and the physical function of the lower extremities among healthy adults. With no adverse events from exercise were reported during the training procedure, the safety and low intensity of Baduanjin exercise was also proved, it could be widely taken as an appropriate no-risk treatment exercise for healthy adults.

The manual control of vehicles undergoing slow transitions in dynamic characteristics

NASA Technical Reports Server (NTRS)

Moriarty, T. E.

1974-01-01

The manual control was studied of a vehicle with slowly time-varying dynamics to develop analytic and computer techniques necessary for the study of time-varying systems. The human operator is considered as he controls a time-varying plant in which the changes are neither abrupt nor so slow that the time variations are unimportant. An experiment in which pilots controlled the longitudinal mode of a simulated time-varying aircraft is described. The vehicle changed from a pure double integrator to a damped second order system, either instantaneously or smoothly over time intervals of 30, 75, or 120 seconds. The regulator task consisted of trying to null the error term resulting from injected random disturbances with bandwidths of 0.8, 1.4, and 2.0 radians per second. Each of the twelve experimental conditons was replicated ten times. It is shown that the pilot's performance in the time-varying task is essentially equivalent to his performance in stationary tasks which correspond to various points in the transition. A rudimentary model for the pilot-vehicle-regulator is presented.

No Effect of Insecticide Treated Curtain Deployment on Aedes Infestation in a Cluster Randomized Trial in a Setting of Low Dengue Transmission in Guantanamo, Cuba

PubMed Central

Lambert, Isora; Montada, Domingo; Baly, Alberto; Van der Stuyft, Patrick

2015-01-01

Objective & Methodology The current study evaluated the effectiveness and cost-effectiveness of Insecticide Treated Curtain (ITC) deployment for reducing dengue vector infestation levels in the Cuban context with intensive routine control activities. A cluster randomized controlled trial took place in Guantanamo city, east Cuba. Twelve neighborhoods (about 500 households each) were selected among the ones with the highest Aedes infestation levels in the previous two years, and were randomly allocated to the intervention and control arms. Long lasting ITC (PermaNet) were distributed in the intervention clusters in March 2009. Routine control activities were continued in the whole study area. In both study arms, we monitored monthly pre- and post-intervention House Index (HI, number of houses with at least 1 container with Aedes immature stages/100 houses inspected), during 12 and 18 months respectively. We evaluated the effect of ITC deployment on HI by fitting a generalized linear regression model with a negative binomial link function to these data. Principal Findings At distribution, the ITC coverage (% of households using ≥1 ITC) reached 98.4%, with a median of 3 ITC distributed/household. After 18 months, the coverage remained 97.4%. The local Aedes species was susceptible to deltamethrin (mosquito mortality rate of 99.7%) and the residual deltamethrin activity in the ITC was within acceptable levels (mosquito mortality rate of 73.1%) after one year of curtain use. Over the 18 month observation period after ITC distribution, the adjusted HI rate ratio, intervention versus control clusters, was 1.15 (95% CI 0.57 to 2.34). The annualized cost per household of ITC implementation was 3.8 USD, against 16.8 USD for all routine ACP activities. Conclusion Deployment of ITC in a setting with already intensive routine Aedes control actions does not lead to reductions in Aedes infestation levels. PMID:25794192

The evidence for immunotherapy in dermatomyositis and polymyositis: a systematic review.

PubMed

Vermaak, Erin; Tansley, Sarah L; McHugh, Neil J

2015-12-01

Dermatomyositis and polymyositis are rare chronic inflammatory disorders with significant associated morbidity and mortality despite treatment. High-dose corticosteroids in addition to other interventions such as immunosuppressants, immunomodulators, and more recently, biologics are commonly used in clinical practice; however, there are no clear guidelines directing their use. Our objective was to systematically review the evidence for immunotherapy in the treatment of dermatomyositis and polymyositis. Relevant studies were identified through Embase and PubMed database searches. Trials were selected using pre-determined selection criteria and then assessed for quality. Randomized controlled trials and experimental studies without true randomization and including adult patients with definite or probable dermatomyositis or polymyositis were evaluated. Any type of immunotherapy was considered. Clinical improvement, judged by assessment of muscle strength after 6 months, was the primary outcome. Secondary outcomes included IMACS definition of improvement, improvements in patient and physician global scores, physical function, and muscle enzymes. Twelve studies met eligibility criteria. Differences in trial design, quality, and variable reporting of baseline characteristics and outcomes made direct comparison impossible. Although no treatment can be recommended on the basis of this review, improved outcomes were demonstrated with a number of agents including methotrexate, azathioprine, ciclosporin, rituximab, and intravenous immunoglobulin. Plasmapheresis and leukapheresis were of no apparent benefit. More high-quality randomized controlled trials are needed to establish the role of immunosuppressive agents in the treatment of these conditions and the clinical context in which they are most likely to be beneficial.

Effects of stimulant medication on the lateralisation of line bisection judgements of children with attention deficit hyperactivity disorder.

PubMed

Sheppard, D M; Bradshaw, J L; Mattingley, J B; Lee, P

1999-01-01

Deficits in the maintenance of attention may underlie problems in attention deficit hyperactivity disorder (ADHD). Children with ADHD also show asymmetric attention deficits in traditional lateralisation and visuospatial orienting tasks, suggesting right hemispheric (and left hemispace) attentional disturbance. This study aimed to examine the lateralisation of selective attention in ADHD; specifically, the effect of a moving, random dot background, and stimulant medication in the line bisection task. The performance of children with ADHD, on and off methylphenidate, was examined using a computerised horizontal line bisection task with moving and blank backgrounds. Twenty children with a DSM-IV diagnosis of ADHD participated with 20 controls, individually matched for age, sex, grade at school, and IQ. Twelve of the 20 children with ADHD were on stimulant medication at the time of testing. Horizontal lines of varying length were presented in the centre of a computer screen, with either a blank background, or a moving, random dot field. The random dots moved either leftward or rightward across the screen at either 40 mm/s or 80 mm/s. The children with ADHD off medication bisected lines significantly further to the right compared with controls, who showed a small leftward error. Methylphenidate normalised the performance of the children with ADHD for the task with the moving dots. These results support previous evidence for a right hemispheric hypoarousal theory of attentional dysfunction, and are consistent with the emerging picture of a lateralised dysfunction of frontostriatal circuitry in ADHD.

Feline mitochondrial DNA sampling for forensic analysis: when enough is enough!

PubMed

Grahn, Robert A; Alhaddad, Hasan; Alves, Paulo C; Randi, Ettore; Waly, Nashwa E; Lyons, Leslie A

2015-05-01

Pet hair has a demonstrated value in resolving legal issues. Cat hair is chronically shed and it is difficult to leave a home with cats without some level of secondary transfer. The power of cat hair as an evidentiary resource may be underused because representative genetic databases are not available for exclusionary purposes. Mitochondrial control region databases are highly valuable for hair analyses and have been developed for the cat. In a representative worldwide data set, 83% of domestic cat mitotypes belong to one of twelve major types. Of the remaining 17%, 7.5% are unique within the published 1394 sample database. The current research evaluates the sample size necessary to establish a representative population for forensic comparison of the mitochondrial control region for the domestic cat. For most worldwide populations, randomly sampling 50 unrelated local individuals will achieve saturation at 95%. The 99% saturation is achieved by randomly sampling 60-170 cats, depending on the numbers of mitotypes available in the population at large. Likely due to the recent domestication of the cat and minimal localized population substructure, fewer cats are needed to meet mitochondria DNA control region database practical saturation than for humans or dogs. Coupled with the available worldwide feline control region database of nearly 1400 cats, minimal local sampling will be required to establish an appropriate comparative representative database and achieve significant exclusionary power. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Meta-analysis of randomized trials on access site selection for percutaneous coronary intervention in ST-segment elevation myocardial infarction

PubMed Central

Komócsi, András; Aradi, Dániel; Kehl, Dániel; Ungi, Imre; Thury, Attila; Pintér, Tünde; Di Nicolantonio, James J.; Tornyos, Adrienn

2014-01-01

Introduction Superior outcomes with transradial (TRPCI) versus transfemoral coronary intervention (TFPCI) in the setting of acute ST-segment elevation myocardial infarction (STEMI) have been suggested by earlier studies. However, this effect was not evident in randomized controlled trials (RCTs), suggesting a possible allocation bias in observational studies. Since important studies with heterogeneous results regarding mortality have been published recently, we aimed to perform an updated review and meta-analysis on the safety and efficacy of TRPCI compared to TFPCI in the setting of STEMI. Material and methods Electronic databases were searched for relevant studies from January 1993 to November 2012. Outcome parameters of RCTs were pooled with the DerSimonian-Laird random-effects model. Results Twelve RCTs involving 5,124 patients were identified. According to the pooled analysis, TRPCI was associated with a significant reduction in major bleeding (odds ratio (OR): 0.52 (95% confidence interval (CI) 0.38–0.71, p < 0.0001)). The risk of mortality and major adverse events was significantly lower after TRPCI (OR = 0.58 (95% CI: 0.43–0.79), p = 0.0005 and OR = 0.67 (95% CI: 0.52–0.86), p = 0.002 respectively). Conclusions Robust data from randomized clinical studies indicate that TRPCI reduces both ischemic and bleeding complications in STEMI. These findings support the preferential use of radial access for primary PCI. PMID:24904651

Meta-analysis of randomized trials on access site selection for percutaneous coronary intervention in ST-segment elevation myocardial infarction.

PubMed

Komócsi, András; Aradi, Dániel; Kehl, Dániel; Ungi, Imre; Thury, Attila; Pintér, Tünde; Di Nicolantonio, James J; Tornyos, Adrienn; Vorobcsuk, András

2014-05-12

Superior outcomes with transradial (TRPCI) versus transfemoral coronary intervention (TFPCI) in the setting of acute ST-segment elevation myocardial infarction (STEMI) have been suggested by earlier studies. However, this effect was not evident in randomized controlled trials (RCTs), suggesting a possible allocation bias in observational studies. Since important studies with heterogeneous results regarding mortality have been published recently, we aimed to perform an updated review and meta-analysis on the safety and efficacy of TRPCI compared to TFPCI in the setting of STEMI. Electronic databases were searched for relevant studies from January 1993 to November 2012. Outcome parameters of RCTs were pooled with the DerSimonian-Laird random-effects model. Twelve RCTs involving 5,124 patients were identified. According to the pooled analysis, TRPCI was associated with a significant reduction in major bleeding (odds ratio (OR): 0.52 (95% confidence interval (CI) 0.38-0.71, p < 0.0001)). The risk of mortality and major adverse events was significantly lower after TRPCI (OR = 0.58 (95% CI: 0.43-0.79), p = 0.0005 and OR = 0.67 (95% CI: 0.52-0.86), p = 0.002 respectively). Robust data from randomized clinical studies indicate that TRPCI reduces both ischemic and bleeding complications in STEMI. These findings support the preferential use of radial access for primary PCI.

Enhancing evidence-based diabetes and chronic disease control among local health departments: a multi-phase dissemination study with a stepped-wedge cluster randomized trial component.

PubMed

Parks, Renee G; Tabak, Rachel G; Allen, Peg; Baker, Elizabeth A; Stamatakis, Katherine A; Poehler, Allison R; Yan, Yan; Chin, Marshall H; Harris, Jenine K; Dobbins, Maureen; Brownson, Ross C

2017-10-18

The rates of diabetes and prediabetes in the USA are growing, significantly impacting the quality and length of life of those diagnosed and financially burdening society. Premature death and disability can be prevented through implementation of evidence-based programs and policies (EBPPs). Local health departments (LHDs) are uniquely positioned to implement diabetes control EBPPs because of their knowledge of, and focus on, community-level needs, contexts, and resources. There is a significant gap, however, between known diabetes control EBPPs and actual diabetes control activities conducted by LHDs. The purpose of this study is to determine how best to support the use of evidence-based public health for diabetes (and related chronic diseases) control among local-level public health practitioners. This paper describes the methods for a two-phase study with a stepped-wedge cluster randomized trial that will evaluate dissemination strategies to increase the uptake of public health knowledge and EBPPs for diabetes control among LHDs. Phase 1 includes development of measures to assess practitioner views on and organizational supports for evidence-based public health, data collection using a national online survey of LHD chronic disease practitioners, and a needs assessment of factors influencing the uptake of diabetes control EBPPs among LHDs within one state in the USA. Phase 2 involves conducting a stepped-wedge cluster randomized trial to assess effectiveness of dissemination strategies with local-level practitioners at LHDs to enhance capacity and organizational support for evidence-based diabetes prevention and control. Twelve LHDs will be selected and randomly assigned to one of the three groups that cross over from usual practice to receive the intervention (dissemination) strategies at 8-month intervals; the intervention duration for groups ranges from 8 to 24 months. Intervention (dissemination) strategies may include multi-day in-person workshops, electronic information exchange methods, technical assistance through a knowledge broker, and organizational changes to support evidence-based public health approaches. Evaluation methods comprise surveys at baseline and the three crossover time points, abstraction of local-level diabetes and chronic disease control program plans and progress reports, and social network analysis to understand the relationships and contextual issues that influence EBPP adoption. ClinicalTrial.gov, NCT03211832.

Instructors' Application of the Theory of Planned Behavior in Teaching Undergraduate Physical Education Courses

ERIC Educational Resources Information Center

Filho, Paulo Jose Barbosa Gutierres; Monteiro, Maria Dolores Alves Ferreira; da Silva, Rudney; Hodge, Samuel R.

2013-01-01

The purpose of this study was to analyze adapted physical education instructors' views about the application of the theory of planned behavior (TpB) in teaching physical education undergraduate courses. Participants ("n" = 17) were instructors of adapted physical activity courses from twelve randomly selected institutions of higher…

Consistency of Toddler Engagement across Two Settings

ERIC Educational Resources Information Center

Aguiar, Cecilia; McWilliam, R. A.

2013-01-01

This study documented the consistency of child engagement across two settings, toddler child care classrooms and mother-child dyadic play. One hundred twelve children, aged 14-36 months (M = 25.17, SD = 6.06), randomly selected from 30 toddler child care classrooms from the district of Porto, Portugal, participated. Levels of engagement were…

On the Impact of Formative Assessment on Student Motivation, Achievement, and Conceptual Change

ERIC Educational Resources Information Center

Yin, Yue; Shavelson, Richard J.; Ayala, Carlos C.; Ruiz-Primo, Maria Araceli; Brandon, Paul R.; Furtak, Erin Marie; Tomita, Miki K.; Young, Donald B.

2008-01-01

Formative assessment was hypothesized to have a beneficial impact on students' science achievement and conceptual change, either directly or indirectly by enhancing motivation. We designed and embedded formatives assessments within an inquiry science unit. Twelve middle-school science teachers with their students were randomly assigned either to…

Evaluation of LEAA Funded Courts Training Programs. Volume I.

ERIC Educational Resources Information Center

McManis Associates, Inc., Washington, DC.

An impact evaluation of eight courts training project (CTP) institutes funded by the Law Enforcement Assistance Administration was conducted. After a literature search and visits to potential evaluation sites in all fifty states, twelve sites were selected from a random stratified sample of court systems. Data were obtained from 1047 respondents…

Preschool Deployment of Evidence-Based Social Communication Intervention: JASPER in the Classroom

ERIC Educational Resources Information Center

Chang, Ya-Chih; Shire, Stephanie Y.; Shih, Wendy; Gelfand, Carolyn; Kasari, Connie

2016-01-01

Few research-developed early intervention models have been deployed to and tested in real world preschool programs. In this study, teaching staff implemented a social communication modularized intervention, JASPER, in their daily program. Sixty-six preschool children with autism in twelve classrooms (12 teachers) were randomized to receive…

Psychological Sources of Systematic Rejection Among White and Black Adolescents.

ERIC Educational Resources Information Center

Long, Samuel

In this study, individual-oriented and system-oriented models of systemic rejection among white and black adolescents are investigated. Systemic rejection is defined as attitudes of political alienation and political violence justification. Twelve hypotheses were generated and tested using survey data collected in May 1976 from a random sample of…

Initial evaluation of floor cooling on lactating sows under severe acute heat stress

USDA-ARS?s Scientific Manuscript database

The objective was to evaluate the effects of floor cooling on lactating sows under severe summer heat stress. Twelve multiparous sows were provided with a cooling pad built with an aluminum plate surface, high-density polyethylene base and copper pipes. Treatments were randomly allotted to sows to r...

The Impact of Massage Therapy on Function in Pain Populations-A Systematic Review and Meta-Analysis of Randomized Controlled Trials: Part III, Surgical Pain Populations.

PubMed

Boyd, Courtney; Crawford, Cindy; Paat, Charmagne F; Price, Ashley; Xenakis, Lea; Zhang, Weimin

2016-09-01

Pain is multi-dimensional and may be better addressed through a holistic, biopsychosocial approach. Massage therapy is commonly practiced among patients seeking pain management; however, its efficacy is unclear. This systematic review and meta-analysis is the first to rigorously assess the quality of the evidence for massage therapy's efficacy in treating pain, function-related, and health-related quality of life outcomes in surgical pain populations. Key databases were searched from inception through February 2014. Eligible randomized controlled trials were assessed for methodological quality using SIGN 50 Checklist. Meta-analysis was applied at the outcome level. A professionally diverse steering committee interpreted the results to develop recommendations. Twelve high quality and four low quality studies were included in the review. Results indicate massage therapy is effective for treating pain [standardized mean difference (SMD) = -0.79] and anxiety (SMD = -0.57) compared to active comparators. Based on the available evidence, weak recommendations are suggested for massage therapy, compared to active comparators for reducing pain intensity/severity and anxiety in patients undergoing surgical procedures. This review also discusses massage therapy safety, challenges within this research field, how to address identified research gaps, and next steps for future research. © 2016 American Academy of Pain Medicine.

Water Treatment Technology - Taste, Odor & Color.

ERIC Educational Resources Information Center

Ross-Harrington, Melinda; Kincaid, G. David

One of twelve water treatment technology units, this student manual on taste, odor, and color provides instructional materials for three competencies. (The twelve units are designed for a continuing education training course for public water supply operators.) The competencies focus on the following areas: taste and odor determination, control of…

Mentalization-based treatment in groups for adolescents with borderline personality disorder (BPD) or subthreshold BPD versus treatment as usual (M-GAB): study protocol for a randomized controlled trial.

PubMed

Beck, Emma; Bo, Sune; Gondan, Matthias; Poulsen, Stig; Pedersen, Liselotte; Pedersen, Jesper; Simonsen, Erik

2016-07-12

Evidence-based outpatient psychotherapeutic programs are first-line treatment of borderline personality disorder (BPD). Early and effective treatment of BPD is crucial to the prevention of its individual, psychosocial, and economic consequences. However, in spite of recent advantages in diagnosing adolescent BPD, there is a lack of cost-effective evidence-based treatment programs for adolescents. Mentalization-based treatment is an evidence-based program for BPD, originally developed for adults. We will investigate whether a specifically designed mentalization-based treatment in groups is an efficacious treatment for adolescents with BPD or subthreshold BPD compared to treatment as usual. The trial is a four-center, two-armed, parallel-group, assessor-blinded randomized clinical superiority trial. One hundred twelve patients aged 14 to 17 referred to Child and Adolescent Psychiatric Clinics in Region Zealand are randomized to 1 year of either mentalization-based treatment in groups or treatment as usual. Patients will be included if they meet at least four DSM-5 criteria for BPD. The primary outcome is self-reported borderline features at discharge. Secondary outcomes will include self-harm, depression, BPD criteria, externalizing and internalizing symptoms, and social functioning, together with parental reports on borderline features, externalizing and internalizing symptoms. Measures of attachment and mentalization will be included as mediational variables. Follow-up assessment will take place at 3 and 12 months after end of treatment. This is the first randomized controlled trial to test the efficacy of a group-based mentalization-based treatment for adolescents with BPD or subthreshold BPD. If the results confirm our hypothesis, this trial will add to the treatment options of cost-effective treatment of adolescent BPD. Clinicaltrials.gov NCT02068326 , February 19, 2014.

Design of the Physical exercise during Adjuvant Chemotherapy Effectiveness Study (PACES): a randomized controlled trial to evaluate effectiveness and cost-effectiveness of physical exercise in improving physical fitness and reducing fatigue.

PubMed

van Waart, Hanna; Stuiver, Martijn M; van Harten, Wim H; Sonke, Gabe S; Aaronson, Neil K

2010-12-07

Cancer chemotherapy is frequently associated with a decline in general physical condition, exercise tolerance, and muscle strength and with an increase in fatigue. While accumulating evidence suggests that physical activity and exercise interventions during chemotherapy treatment may contribute to maintaining cardiorespiratory fitness and strength, the results of studies conducted to date have not been consistent. Additional research is needed to determine the optimal intensity of exercise training programs in general and in particular the relative effectiveness of supervised, outpatient (hospital- or physical therapy practice-based) versus home-based programs. This multicenter, prospective, randomized trial will evaluate the effectiveness of a low to moderate intensity, home-based, self-management physical activity program, and a high intensity, structured, supervised exercise program, in maintaining or enhancing physical fitness (cardiorespiratory fitness and muscle strength), in minimizing fatigue and in enhancing the health-related quality of life (HRQoL). Patients receiving adjuvant chemotherapy for breast or colon cancer (n = 360) are being recruited from twelve hospitals in the Netherlands, and randomly allocated to one of the two treatment groups or to a 'usual care' control group. Performance-based and self-reported outcomes are assessed at baseline, at the end of chemotherapy and at six month follow-up. This large, multicenter, randomized clinical trial will provide additional empirical evidence regarding the effectiveness of physical exercise during adjuvant chemotherapy in enhancing physical fitness, minimizing fatigue, and maintaining or enhancing patients' quality of life. If demonstrated to be effective, exercise intervention programs will be a welcome addition to the standard program of care offered to patients with cancer receiving chemotherapy. This study is registered at the Netherlands Trial Register (NTR 2159).

Effectiveness of a multimodal standard nursing program on health-related quality of life in Chinese mainland female patients with breast cancer: protocol for a single-blind cluster randomized controlled trial.

PubMed

Zhou, Kaina; Wang, Duolao; He, Xiaole; Huo, Lanting; An, Jinghua; Li, Minjie; Wang, Wen; Li, Xiaomei

2016-08-31

Breast cancer and its treatment-related adverse effects are harmful to physical, psychological, and social functioning, leading to health-related quality of life (HRQoL) impairment in patients. Many programs have been used with this population for HRQoL improvement; however, few studies have considered the physical, psychological, and social health domains comprehensively, and few have constructed multimodal standard nursing interventions based on specific theories. The purpose of this trial is to examine the effect of a health belief model (HBM)-based multimodal standard nursing program (MSNP) on HRQoL in female patients with breast cancer. This is a two-arm single-blind cluster randomized controlled trial (cRCT) in clinical settings. Twelve tertiary hospitals will be randomly selected from the 24 tertiary hospitals in Xi'an, China, and allocated to the intervention arm and control arm using a computer-generated random numbers table. Inpatient female patients with breast cancer from each hospital will receive either MSNP plus routine nursing care immediately after recruitment (intervention arm), or only routine nursing care (control arm). The intervention will be conducted by trained nurses for 12 months. All recruited female patients with breast cancer, participating clinical staff, and trained data collectors from the 12 hospitals will be blind with respect to group allocation. Patients of the control arm will not be offered any information about the MSNP during the study period to prevent bias. The primary outcome is HRQoL measured through the Functional Assessment of Cancer Therapy-Breast version 4.0 at 12 months. Secondary outcomes include pain, fatigue, sleep, breast cancer-related lymphedema, and upper limb function, which are evaluated by a visual analogue scale, the circumference method, and the Constant-Murley Score. This trial will provide important evidence on the effectiveness of multimodal nursing interventions delivered by nurses in clinical settings. Study findings will inform strategies for scaling up comprehensive standard intervention programs on health management in the population of female patients with breast cancer. Chictr.org.cn ChiCTR-IOR-16008253 (April 9, 2016).

Empowerment of personal injury victims through the internet: design of a randomized controlled trial.

PubMed

Elbers, Nieke A; Akkermans, Arno J; Cuijpers, Pim; Bruinvels, David J

2011-02-02

Research has shown that current claims settlement process can have a negative impact on psychological and physical recovery of personal injury (PI) victims. One of the explanations for the negative impact on health is that the claims settlement process is a stressful experience and victims suffer from renewed victimization caused by the claims settlement process. PI victims can experience a lack of information, lack of involvement, lack of 'voice', and poor communication. We present the first study that aims to empower PI victims with respect to the negative impact of the claims settlement process by means of an internet intervention. The study is a two armed, randomized controlled trial (RCT), in which 170 PI victims are randomized to either the intervention or control group. The intervention group will get access to a website providing 1) an information module, so participants learn what is happening and what to expect during the claims settlement process, and 2) an e-coach module, so participants learn to cope with problems they experience during the claims settlement process. The control group will get access to a website with hyperlinks to commonly available information only. Participants will be recruited via a PI claims settlement office. Participants are included if they have been involved in a traffic accident which happened less than two years ago, and are at least 18 years old.The main study parameter is the increase of empowerment within the intervention group compared to the control group. Empowerment will be measured by the mastery scale and a self-efficacy scale. The secondary outcomes are perceived justice, burden, well being, work ability, knowledge, amount of damages, and lawyer-client communication. Data are collected at baseline (T0 measurement before randomization), at three months, six months, and twelve months after baseline. Analyses will be conducted according to the intention-to-treat principle. This study evaluates the effectiveness of an internet intervention aimed at empowerment of PI victims. The results will give more insight into the impact of compensation proceedings on health over time, and they can have important consequences for legal claims settlement. Strengths and limitations of this study are discussed. Netherlands Trial Register NTR2360.

Efficacy and safety of creatine supplementation in juvenile dermatomyositis: A randomized, double-blind, placebo-controlled crossover trial.

PubMed

Solis, Marina Yazigi; Hayashi, Ana Paula; Artioli, Guilherme Giannini; Roschel, Hamilton; Sapienza, Marcelo Tatit; Otaduy, Maria Concepción; De Sã Pinto, Ana Lucia; Silva, Clovis Artur; Sallum, Adriana Maluf Elias; Pereira, Rosa Maria R; Gualano, Bruno

2016-01-01

It has been suggested that creatine supplementation is safe and effective for treating idiopathic inflammatory myopathies, but no pediatric study has been conducted to date. The objective of this study was to examine the efficacy and safety of creatine supplementation in juvenile dermatomyositis (JDM) patients. In this study, JDM patients received placebo or creatine supplementation (0.1 g/kg/day) in a randomized, crossover, double-blind design. Subjects were assessed at baseline and after 12 weeks. The primary outcome was muscle function. Secondary outcomes included body composition, aerobic conditioning, health-related quality of life, and muscle phosphocreatine (PCr) content. Safety was assessed by laboratory parameters and kidney function measurements. Creatine supplementation did not affect muscle function, intramuscular PCr content, or any other secondary outcome. Kidney function was not affected, and no side effects were reported. Twelve weeks of creatine supplementation in JDM patients were well-tolerated and free of adverse effects, but treatment did not affect muscle function, intramuscular PCr, or any other parameter. © 2015 Wiley Periodicals, Inc.

Short-term outcomes of extracorporeal shock wave therapy for the treatment of chronic non-calcific tendinopathy of the supraspinatus: a double-blind, randomized, placebo-controlled trial

PubMed Central

2012-01-01

Background There is evidence supporting the use of extracorporeal shock wave therapy (ESWT) in calcific tendinopathy of the rotator cuff, but the best current evidence does not support its use in non-calcifying tendinopathy. We conducted a randomized placebo-controlled trial to investigate the efficacy and safety of low energy ESWT for non-calcifying tendinopathy of the rotator cuff. Methods 20 patients with non-calcifying supraspinatus tendinopathy (NCST) were randomized to an active or a sham treatment group. Physical, blood, roentgenographic, and MRI examinations of the shoulder were conducted to verify that patients met the inclusion and exclusion criteria. These examinations were repeated six and twelve weeks after treatments. Effectiveness was determined by comparison of the mean improvement in the Constant and Murley score (CMS) between the treatment and the placebo groups at three months. Safety was assessed by analyzing the number and severity of adverse events. Results All the patients completed the investigation protocol. At the final follow-up, significant improvement in the total CMS score and most of the CMS subscales was observed in the ESWT group when compared to the baseline values. Significantly higher total CMS, and significantly higher scores for CMS pain and ROM were observed in the ESWT group when compared to the placebo. No serious adverse events were noted after ESWT. Conclusions Patients suffering from NCST may benefit from low energy ESWT, at least in short-term. The application protocol of ESWT is likely to play a key-role in a successful treatment. Future investigations should be undertaken on the long-term effects of this technique for the treatment of NCST. Trial registration Current Controlled Trials ISRCTN41236511 PMID:22672772

Nigral stimulation for resistant axial motor impairment in Parkinson's disease? A randomized controlled trial.

PubMed

Weiss, Daniel; Walach, Margarete; Meisner, Christoph; Fritz, Melanie; Scholten, Marlieke; Breit, Sorin; Plewnia, Christian; Bender, Benjamin; Gharabaghi, Alireza; Wächter, Tobias; Krüger, Rejko

2013-07-01

Gait and balance disturbances typically emerge in advanced Parkinson's disease with generally limited response to dopaminergic medication and subthalamic nucleus deep brain stimulation. Therefore, advanced programming with interleaved pulses was put forward to introduce concomittant nigral stimulation on caudal contacts of a subthalamic lead. Here, we hypothesized that the combined stimulation of subthalamic nucleus and substantia nigra pars reticulata improves axial symptoms compared with standard subthalamic nucleus stimulation. Twelve patients were enrolled in this 2 × 2 cross-over double-blind randomized controlled clinical trial and both the safety and efficacy of combined subthalamic nucleus and substantia nigra pars reticulata stimulation were evaluated compared with standard subthalamic nucleus stimulation. The primary outcome measure was the change of a broad-scaled cumulative axial Unified Parkinson's Disease Rating Scale score (Scale II items 13-15, Scale III items 27-31) at '3-week follow-up'. Secondary outcome measures specifically addressed freezing of gait, balance, quality of life, non-motor symptoms and neuropsychiatric symptoms. For the primary outcome measure no statistically significant improvement was observed for combined subthalamic nucleus and substantia nigra pars reticulata stimulation at the '3-week follow-up'. The secondary endpoints, however, revealed that the combined stimulation of subthalamic nucleus and substantia nigra pars reticulata might specifically improve freezing of gait, whereas balance impairment remained unchanged. The combined stimulation of subthalamic nucleus and substantia nigra pars reticulata was safe, and of note, no clinically relevant neuropsychiatric adverse effect was observed. Patients treated with subthalamic nucleus and substantia nigra pars reticulata stimulation revealed no 'global' effect on axial motor domains. However, this study opens the perspective that concomittant stimulation of the substantia nigra pars reticulata possibly improves otherwise resistant freezing of gait and, therefore, highly warrants a subsequent phase III randomized controlled trial.

Short-term outcomes of extracorporeal shock wave therapy for the treatment of chronic non-calcific tendinopathy of the supraspinatus: a double-blind, randomized, placebo-controlled trial.

PubMed

Galasso, Olimpio; Amelio, Ernesto; Riccelli, Daria Anna; Gasparini, Giorgio

2012-06-06

There is evidence supporting the use of extracorporeal shock wave therapy (ESWT) in calcific tendinopathy of the rotator cuff, but the best current evidence does not support its use in non-calcifying tendinopathy. We conducted a randomized placebo-controlled trial to investigate the efficacy and safety of low energy ESWT for non-calcifying tendinopathy of the rotator cuff. 20 patients with non-calcifying supraspinatus tendinopathy (NCST) were randomized to an active or a sham treatment group. Physical, blood, roentgenographic, and MRI examinations of the shoulder were conducted to verify that patients met the inclusion and exclusion criteria. These examinations were repeated six and twelve weeks after treatments. Effectiveness was determined by comparison of the mean improvement in the Constant and Murley score (CMS) between the treatment and the placebo groups at three months. Safety was assessed by analyzing the number and severity of adverse events. All the patients completed the investigation protocol. At the final follow-up, significant improvement in the total CMS score and most of the CMS subscales was observed in the ESWT group when compared to the baseline values. Significantly higher total CMS, and significantly higher scores for CMS pain and ROM were observed in the ESWT group when compared to the placebo. No serious adverse events were noted after ESWT. Patients suffering from NCST may benefit from low energy ESWT, at least in short-term. The application protocol of ESWT is likely to play a key-role in a successful treatment. Future investigations should be undertaken on the long-term effects of this technique for the treatment of NCST. Current Controlled Trials ISRCTN41236511.

Evaluation of pain and function after two home exercise programs in a clinical trial on women with chronic neck pain - with special emphasises on completers and responders

PubMed Central

2014-01-01

Background Different types of exercises can help manage chronic neck pain. Supervised exercise interventions are widely used, but these protocols require substantial resources. The aim of this trial, which focused on adherence, was to evaluate two home exercise interventions. Methods This parallel group randomized controlled trial included 57 women randomly allocated into two groups – a strength training group (STRENGTH, 34 subjects) and a stretching group (STRETCH, 23 subjects). The interventions focused on the neck and shoulder muscles and lasted for 12 months. The STRENGTH group performed weight training and ended each session with stretching exercises. These stretching exercises constituted the entirety of the STRETCH group’s training session. Both groups were instructed to exercise three times per week. All the participants kept an exercise diary. In addition, all participants were offered support via phone and e-mail. The primary outcomes were pain intensity and function. The trial included a four- to six-month and a twelve-month follow-up. A completer in this study exercised at least 1,5 times per week during eight unbroken weeks. A responder in this study reported clinically significant improvements on pain and function. The statistical analyses used the Mann Whitney U-test, Wilcoxon signed-rank test, and X 2 test. Results At four- to six-months, the numbers of completers were 19 in the STRENGTH group and 17 in the STRETCH group. At twelve months, the corresponding numbers were 11 (STRENGTH) and 10 (STRETCH). At four- to six-months, the proportions of subjects reporting clinically important changes (STRENGTH and STRETCH) were for neck pain: 47% and 41%, shoulder pain: 47% and 47%, function: 37% and 29%. At twelve months, the corresponding numbers were for neck pain: 45% and 40%, shoulder pain: 55% and 50%, function: 55% and 20%. Conclusions No differences in the two primary outcomes between the two interventions were found, a finding that may be due to the insufficient statistical power of the study. Both interventions based on home exercises improved the two primary outcomes, but the adherences were relatively low. Future studies should investigate ways to improve adherence to home exercise treatments. Trial registration ClinicalTrials.gov Id: NCT01876680 PMID:24400934

A multi-level intervention in subsidized housing sites to increase fruit and vegetable access and intake: Rationale, design and methods of the 'Live Well, Viva Bien' cluster randomized trial.

PubMed

Gans, Kim M; Gorham, Gemma; Risica, Patricia M; Dulin-Keita, Akilah; Dionne, Laura; Gao, Tina; Peters, Sarah; Principato, Ludovica

2016-06-28

Adequate fruit and vegetable (F&V) intake is important for disease prevention. Yet, most Americans, especially low-income and racial/ethnic minorities, do not eat adequate amounts. These disparities are partly attributable to food environments in low-income neighborhoods where residents often have limited access to affordable, healthful food and easy access to inexpensive, unhealthful foods. Increasing access to affordable healthful food in underserved neighborhoods through mobile markets is a promising, year-round strategy for improving dietary behaviors and reducing F&V intake disparities. However, to date, there have been no randomized controlled trials studying their effectiveness. The objective of the 'Live Well, Viva Bien' (LWVB) cluster randomized controlled trial is to evaluate the efficacy of a multicomponent mobile market intervention at increasing F&V intake among residents of subsidized housing complexes. One housing complex served as a pilot site for the intervention group and the remaining 14 demographically-matched sites were randomized into either the intervention or control group. The intervention group received bimonthly, discount, mobile, fresh F&V markets in conjunction with a nutrition education intervention (two F&V campaigns, newsletters, DVDs and cooking demonstrations) for 12 months. The control group received physical activity and stress reduction interventions. Outcome measures include F&V intake (measured by two validated F&V screeners at baseline, six-month and twelve-months) along with potential psychosocial mediating variables. Extensive quantitative and qualitative process evaluation was also conducted throughout the study. Modifying neighborhood food environments in ways that increase access to affordable, healthful food is a promising strategy for improving dietary behaviors among low-income, racial and ethnic minority groups at increased risk for obesity and other food-related chronic diseases. Discount, mobile F&V markets address all the major barriers to eating more F&V (high cost, poor quality, limited access and limited time to shop and cook) and provide a year-round solution to limited access to healthful food in low-income neighborhoods. LWVB is the first randomized controlled trial evaluating the effectiveness of mobile markets at increasing F&V intake. If proven efficacious at increasing F&V consumption, LWVB could be disseminated widely to neighborhoods that have low access to fresh F&V. Clinicatrials.gov registration number: NCT02669472 First Received: January 19, 2016.

A randomized controlled trial of 8-form Tai chi improves symptoms and functional mobility in fibromyalgia patients

PubMed Central

Sherman, Christy A.; Mist, Scott D.; Carson, James W.; Bennett, Robert M.; Li, Fuzhong

2017-01-01

Previous researchers have found that 10-form Tai chi yields symptomatic benefit in patients with fibromyalgia (FM). The purpose of this study was to further investigate earlier findings and add a focus on functional mobility. We conducted a parallel-group randomized controlled trial FM-modified 8-form Yang-style Tai chi program compared to an education control. Participants met in small groups twice weekly for 90 min over 12 weeks. The primary endpoint was symptom reduction and improvement in self-report physical function, as measured by the Fibromyalgia Impact Questionnaire (FIQ), from baseline to 12 weeks. Secondary endpoints included pain severity and interference (Brief Pain Inventory (BPI), sleep (Pittsburg sleep Inventory), self-efficacy, and functional mobility. Of the 101 randomly assigned subjects (mean age 54 years, 93 % female), those in the Tai chi condition compared with the education condition demonstrated clinically and statistically significant improvements in FIQ scores (16.5 vs. 3.1, p=0.0002), BPI pain severity (1.2 vs. 0.4, p=0.0008), BPI pain interference (2.1 vs. 0.6, p=0.0000), sleep (2.0 vs. −0.03, p=0.0003), and self-efficacy for pain control (9.2 vs. −1.5, p=0.0001). Functional mobility variables including timed get up and go (−.9 vs. −.3, p=0.0001), static balance (7.5 vs. −0.3, p= 0.0001), and dynamic balance (1.6 vs. 0.3, p=0.0001) were significantly improved with Tai chi compared with education control. No adverse events were noted. Twelve weeks of Tai chi, practice twice weekly, provided worthwhile improvement in common FM symptoms including pain and physical function including mobility. Tai chi appears to be a safe and an acceptable exercise modality that may be useful as adjunctive therapy in the management of FM patients. (ClinicalTrials.gov Identifier, NCT01311427) PMID:22581278

A randomized controlled trial of 8-form Tai chi improves symptoms and functional mobility in fibromyalgia patients.

PubMed

Jones, Kim D; Sherman, Christy A; Mist, Scott D; Carson, James W; Bennett, Robert M; Li, Fuzhong

2012-08-01

Previous researchers have found that 10-form Tai chi yields symptomatic benefit in patients with fibromyalgia (FM). The purpose of this study was to further investigate earlier findings and add a focus on functional mobility. We conducted a parallel-group randomized controlled trial FM-modified 8-form Yang-style Tai chi program compared to an education control. Participants met in small groups twice weekly for 90 min over 12 weeks. The primary endpoint was symptom reduction and improvement in self-report physical function, as measured by the Fibromyalgia Impact Questionnaire (FIQ), from baseline to 12 weeks. Secondary endpoints included pain severity and interference (Brief Pain Inventory (BPI), sleep (Pittsburg sleep Inventory), self-efficacy, and functional mobility. Of the 101 randomly assigned subjects (mean age 54 years, 93 % female), those in the Tai chi condition compared with the education condition demonstrated clinically and statistically significant improvements in FIQ scores (16.5 vs. 3.1, p = 0.0002), BPI pain severity (1.2 vs. 0.4, p = 0.0008), BPI pain interference (2.1 vs. 0.6, p = 0.0000), sleep (2.0 vs. -0.03, p = 0.0003), and self-efficacy for pain control (9.2 vs. -1.5, p = 0.0001). Functional mobility variables including timed get up and go (-.9 vs. -.3, p = 0.0001), static balance (7.5 vs. -0.3, p    0.0001), and dynamic balance (1.6 vs. 0.3, p = 0.0001) were significantly improved with Tai chi compared with education control. No adverse events were noted. Twelve weeks of Tai chi, practice twice weekly, provided worthwhile improvement in common FM symptoms including pain and physical function including mobility. Tai chi appears to be a safe and an acceptable exercise modality that may be useful as adjunctive therapy in the management of FM patients. (ClinicalTrials.gov Identifier, NCT01311427).

Optically measured NADH concentrations are unaffected by propofol induced EEG silence during transient cerebral hypoperfusion in anesthetized rabbits☆

PubMed Central

Wang, Mei; Agarwal, Sachin; Mayevsky, Avraham; Joshi, Shailendra

2014-01-01

The neuroprotective benefit of intra-operative anesthetics is widely described and routinely aimed to invoke electroencephalographic (EEG) silence in anticipation of transient cerebral ischemia. Previous rat survival studies have questioned an additional benefit from achieving EEG silence during transient global cerebral hypoperfusion. Surgical preparation on twelve New Zealand white rabbits under ketamine–propofol anesthesia, included placement of skull screws for bilateral EEG monitoring, skull shaving for laser Doppler probes, and a 5 mm diameter right temporal craniotomy for the NADH probe. Transient global cerebral hypoperfusion was achieved with bilateral internal carotid artery occlusion and pharmacologically induced systemic hypotension. All animals acted as controls, and had cerebral hypoperfusion under baseline propofol anesthesia with an active EEG. Thereafter, animals were randomized to receive bolus injection of intracarotid (3–5 mg) or intravenous (10–20 mg) 1% propofol to create EEG silence for 1–2 min. The data collected at baseline, peak hypoperfusion, and 5 and 10 min post hypoperfusion was analyzed by repeated measures ANOVA with post hoc Bonferroni–Dunn test. Eleven of the twelve rabbits completed the protocol. Hemodynamics and cerebral blood flow changes were comparable in all the animals. Compared to controls, the increase in NADH during ischemia was unaffected by EEG silence with either intravenous or intraarterial propofol. We failed to observe any significant additional attenuation of the elevation in NADH levels with propofol induced EEG silence during transient global cerebral hypoperfusion. This is consistent with previous rat survival studies showing that EEG silence was not required for full neuroprotective effects of pentothal anesthesia. PMID:21570061

Vegetarian Diets and Weight Reduction: a Meta-Analysis of Randomized Controlled Trials.

PubMed

Huang, Ru-Yi; Huang, Chuan-Chin; Hu, Frank B; Chavarro, Jorge E

2016-01-01

Vegetarian diets may promote weight loss, but evidence remains inconclusive. PubMed, EMBASE and UpToDate databases were searched through September 22, 2014, and investigators extracted data regarding study characteristics and assessed study quality among selected randomized clinical trials. Population size, demographic (i.e., gender and age) and anthropometric (i.e., body mass index) characteristics, types of interventions, follow-up periods, and trial quality (Jadad score) were recorded. The net changes in body weight of subjects were analyzed and pooled after assessing heterogeneity with a random effects model. Subgroup analysis was performed based on type of vegetarian diet, type of energy restriction, study population, and follow-up period. Twelve randomized controlled trials were included, involving a total of 1151 subjects who received the intervention over a median duration of 18 weeks. Overall, individuals assigned to the vegetarian diet groups lost significantly more weight than those assigned to the non-vegetarian diet groups (weighted mean difference, -2.02 kg; 95 % confidence interval [CI]: -2.80 to -1.23). Subgroup analysis detected significant weight reduction in subjects consuming a vegan diet (-2.52 kg; 95 % CI: -3.02 to -1.98) and, to a lesser extent, in those given lacto-ovo-vegetarian diets (-1.48 kg; 95 % CI: -3.43 to 0.47). Studies on subjects consuming vegetarian diets with energy restriction (ER) revealed a significantly greater weight reduction (-2.21 kg; 95 % CI: -3.31 to -1.12) than those without ER (-1.66 kg; 95 % CI: -2.85 to -0.48). The weight loss for subjects with follow-up of <1 year was greater (-2.05 kg; 95 % CI: -2.85 to -1.25) than those with follow-up of ≥1 year (-1.13 kg; 95 % CI: -2.04 to -0.21). Vegetarian diets appeared to have significant benefits on weight reduction compared to non-vegetarian diets. Further long-term trials are needed to investigate the effects of vegetarian diets on body weight control.

A randomized controlled trial to determine the effects of music and relaxation interventions on perceived anxiety in hospitalized patients receiving orthopaedic or cancer treatment.

PubMed

Eckhouse, Diane R; Hurd, Mary; Cotter-Schaufele, Susan; Sulo, Suela; Sokolowski, Malgorzata; Barbour, Laurel

2014-01-01

Nonpharmacological interventions, including combinations of music, education, coping skills, and relaxation techniques, have been found to have a positive effect on patients' perceived anxiety in many settings. However, few research studies have assessed and compared the effectiveness of music and relaxation interventions in reducing the anxiety levels of orthopaedic and oncology patients. We conducted a prospective, randomized, controlled study to examine the effectiveness of music and relaxation interventions on perceived anxiety during initial hospitalization for patients receiving orthopaedic or cancer care treatment at a Midwestern teaching hospital. This was a pre-test/post-test study design utilizing the State-Trait Anxiety Inventory. One hundred twelve patients were randomized into 3 study groups. Thirty-eight subjects (34%) were randomized in the music-focused relaxation group, 35 subjects (31%) in the music and video group, and 39 (35%) subjects in the control group. Fifty-seven (51%) were orthopaedic patients and 55 (49%) were oncology patients. Comparison of the 3 study groups showed no statistically significant differences with regard to patients' demographics. Although reduced anxiety levels were reported for all 3 groups postintervention, the differences were not statistically significant (p > .05). Also, there was no significant difference found between the perceived anxiety levels of patients admitted to the orthopaedic and oncology care units (p > .05). Finally, the results of the intragroup comparisons (regardless of the group assignment) showed a significant decrease in anxiety levels reported by all patients postintervention (p < .001). Music and relaxation interventions could be an additional tool in assisting patients to become less anxious during their hospital stay. Music focused relaxation and music and video are both valuable and cost-effective strategies that can assist the orthopaedic and oncology patient population. Identifying opportunities to make these interventions easily accessible to healthcare professionals can assist in the management of patient anxiety during hospitalization.

Enriched Air Nitrox Breathing Reduces Venous Gas Bubbles after Simulated SCUBA Diving: A Double-Blind Cross-Over Randomized Trial.

PubMed

Souday, Vincent; Koning, Nick J; Perez, Bruno; Grelon, Fabien; Mercat, Alain; Boer, Christa; Seegers, Valérie; Radermacher, Peter; Asfar, Pierre

2016-01-01

To test the hypothesis whether enriched air nitrox (EAN) breathing during simulated diving reduces decompression stress when compared to compressed air breathing as assessed by intravascular bubble formation after decompression. Human volunteers underwent a first simulated dive breathing compressed air to include subjects prone to post-decompression venous gas bubbling. Twelve subjects prone to bubbling underwent a double-blind, randomized, cross-over trial including one simulated dive breathing compressed air, and one dive breathing EAN (36% O2) in a hyperbaric chamber, with identical diving profiles (28 msw for 55 minutes). Intravascular bubble formation was assessed after decompression using pulmonary artery pulsed Doppler. Twelve subjects showing high bubble production were included for the cross-over trial, and all completed the experimental protocol. In the randomized protocol, EAN significantly reduced the bubble score at all time points (cumulative bubble scores: 1 [0-3.5] vs. 8 [4.5-10]; P < 0.001). Three decompression incidents, all presenting as cutaneous itching, occurred in the air versus zero in the EAN group (P = 0.217). Weak correlations were observed between bubble scores and age or body mass index, respectively. EAN breathing markedly reduces venous gas bubble emboli after decompression in volunteers selected for susceptibility for intravascular bubble formation. When using similar diving profiles and avoiding oxygen toxicity limits, EAN increases safety of diving as compared to compressed air breathing. ISRCTN 31681480.

The Sustained Impact of Teacher Encouragement on Elementary Students' Vegetable Snack Consumption: Initial Findings from a Wisconsin Study

ERIC Educational Resources Information Center

Jamelske, Eric M.; Vernon, Erin

2018-01-01

Purpose/Objectives: The purpose of this study was to determine the impact of teacher encouragement on elementary school student vegetable snack consumption. Methods: Twelve Wisconsin elementary school teachers were randomly assigned different levels of encouragement procedures during vegetable snack time. The consumption levels of 218 students…

The Effects of Television Advertising on Children: Survey of Children's and Mother's Responses to Television Commercials. Final Report.

ERIC Educational Resources Information Center

Atkin, Charles K.

This research assesses reactions to Saturday morning television advertising by four to twelve year old children and their mothers and examines young viewers' naturalistic learning of facts, attitudes, and behavior from commercials. An omnibus questionnaire was administered to 738 children. Interviews were conducted with 301 randomly selected…

Using Educational Technology to Develop Early Literacy Skills in Sub-Saharan Africa

ERIC Educational Resources Information Center

Abrami, Philip C.; Wade, C. Anne; Lysenko, Larysa; Marsh, Jonathon; Gioko, Anthony

2016-01-01

The research explores the impact of interactive, multimedia literacy software (ABRA) on the reading skills of early elementary students in Kenya. Twelve grade two English teachers and their students from six schools were randomly divided in half: an experimental group (N = 180) where ABRA was part of their English Language instruction and a…

Effects of behavioural exercise therapy on the effectiveness of a multidisciplinary rehabilitation for chronic non-specific low back pain: study protocol for a randomised controlled trial.

PubMed

Hofmann, Jana; Peters, Stefan; Geidl, Wolfgang; Hentschke, Christian; Pfeifer, Klaus

2013-03-11

In Germany, a multidisciplinary rehabilitation named "behavioural medical rehabilitation" (BMR) is available for treatment of chronic low back pain (clbp). A central component of BMR is standard exercise therapy (SET), which is directed mainly to improve physical fitness. There is a need to address psychosocial factors within SET and therefore to improve behavior change with a focus on the development of self-management skills in dealing with clbp. Furthermore, short-term effectiveness of BMR with a SET has been proven, but the impact of a behavioural exercise therapy (BET) for improvement of the long-term effectiveness of BMR is unclear. To compare the effectiveness of two exercise programs with different approaches within BMR on the effects of BMR a prospective randomized controlled trial (RCT) in two rehabilitation centres will be performed. 214 patients aged 18-65 with clbp will be, based on an "urn randomisation"-algorithm, randomly assigned to a BMR with SET (function-oriented, n=107) and BMR with BET (behaviour-oriented, n=107). Both exercise programs have a mean duration of 26 hours in three weeks and are delivered by a limited number of not-blinded study therapists in closed groups with six to twelve patients who will be masked regarding study group. The main differences of BET lie in its detailed manualised program with a theory-based, goal-orientated combination of exercise, education and behavioural elements, active participation of patients and consideration of their individual preferences and previous experiences with exercise. The primary outcome is functional ability assessed with the Hannover Functional Ability Questionnaire directly before and after the rehabilitation program, as well as a six and twelve-month follow-up. This RCT is designed to explore the effects of BET on the effectiveness of a BMR compared to a BMR with SET in the management of patients with clbp. Methodological challenges arise from conducting a RCT within routine health care as well as from ensuring high treatment integrity. Findings of this study might contribute to a better understanding of the mechanism of action of BMR and the special effects of BET and may be used to improve the quality of these interventions in routine care, therefore reducing the burden to patients with disabling clbp. Current controlled trials NCT01666639.

Resistance Training Improves Muscle Function and Cardiometabolic Risks But Not Quality of Life in Older People With Type 2 Diabetes Mellitus: A Randomized Controlled Trial.

PubMed

Hsieh, Ping-Lun; Tseng, Chin-Hsiao; Tseng, Yufeng Jane; Yang, Wei-Shiung

In older people with type 2 diabetes mellitus (T2DM), the effects of aging and T2DM may compromise the function of skeletal muscle, deteriorate metabolic status, and jeopardize physical performance, aerobic capacity, and quality of life (QoL). The purpose of this study was to investigate the effects of 12 weeks of resistance training (RT) on muscle function, physical performance, cardiometabolic risks, and QoL in older people with T2DM. This study was a randomized controlled trial that employed block randomization, assessor blinding, and the intention-to-treat principle. Thirty people 65 years or older with a diagnosis of T2DM were randomly assigned to either an exercise group or a control group and were further stratified by gender. The exercise group performed 8 RT exercises in 3 sets of 8 to 12 repetitions at 75% 1-repetition maximum (1-RM) 3 times per week for 12 weeks. The control group received usual care and maintained their daily activities and lifestyle. Muscle function (1-RM and muscle oxygenation responses), physical performance (5-repetition sit-to-stand test and Timed Up and Go test), cardiometabolic risks (aerobic capacity, blood pressure, body composition, glycemic control, lipids levels, and high-sensitivity C-reactive protein levels), and QoL (Audit of Diabetes-Dependent Quality of Life 19) were assessed at baseline (week 0) and after the 12-week interventions (week 12). The 1-RM chest-press and leg-press strength and physical performance in 5-repetition sit-to-stand test were significantly improved in the exercise group compared with the controls after the interventions. The exercise group had significantly lower resting systolic blood pressure (by -12.1 mm Hg, P = 0.036) than did the controls after 12 weeks of RT, without any significant within-group change in either group after intervention. The waist circumference, fasting glucose levels, and peak diastolic blood pressure tended to favor RT over usual care after the interventions. Twelve weeks of RT increased the maximal strength in chest-press and leg-press tests, and improved 5-repetition sit-to-stand performance in older people with T2DM. Our study demonstrated that supervised, structured RT was able to promote muscle function and alleviate cardiometabolic risks in people with T2DM 65 years or older.

Educating preschoolers about sun safety.

PubMed Central

Loescher, L J; Emerson, J; Taylor, A; Christensen, D H; McKinney, M

1995-01-01

OBJECTIVES. This feasibility study examined whether a sun safety curriculum designed for and administered to preschoolers affects their cognition (knowledge, comprehension, application) regarding sun safety. METHODS. Twelve classes of 4- to 5-year-olds were recruited from local preschools and randomly assigned to an intervention group or a control group. The intervention group received an investigator-developed sun safety curriculum; the control group did not. Children in both groups were tested at the beginning of the study about their cognition related to sun safety. They then received posttests 2 and 7 weeks following the pretest. RESULTS. The curriculum had a significant effect on the knowledge (P = .01) and comprehension (P = .006) components of cognition. The application component of cognition was not significantly changed by the curriculum. CONCLUSIONS. A structured curriculum was found to be an efficacious means of enhancing knowledge and comprehension of sun safety in preschool children. At the preoperational developmental stage, however, children may not be able to apply such knowledge and comprehension. PMID:7604917

Inhaled antibiotics in non-cystic fibrosis bronchiectasis: A meta-analysis.

PubMed

Xu, Li; Zhang, Fei; Du, Shuai; Yu, Qi; Chen, Lin; Long, Li-Hui; Li, Ya-Ming; Jia, Ai-Hua

2016-09-01

To evaluate the efficacy and safety of inhaled antibiotics for the treatment of non-cystic fibrosis bronchiectasis (NCFB). Pubmed, Cochrane library, Embase, Elsevier, OVID, Springerlink, Web of knowledge and NEJM were searched for randomized controlled trials (RCTs) on inhaled antibiotics in treatment of NCFB from inception until April 2015. Meta-analysis was conducted to assess the efficacy and safety of inhaled antibiotics in the treatment of NCFB. Twelve RCTs involving 1154 participants were included. They showed that inhaled antibiotics were more effective in reduction of sputum bacterial density, eradication of P. aeruginosa, prolonged time to exacerbation and reduction of new pathogens emergence with no significant difference in adverse events compared with control groups. However, we did not find significant benefits of inhaled antibiotics in reducing the risk of acute exacerbation, improving health-related quality of life and reduction of P. aeruginosa resistance. Moreover, inhaled antibiotics exerted a statistically significant reduction in FEV1%. Inhaled antibiotics may be an alternative pathway to inhibit airway inflammation with no more adverse events in patients with NCFB.

Collocation and Pattern Recognition Effects on System Failure Remediation

NASA Technical Reports Server (NTRS)

Trujillo, Anna C.; Press, Hayes N.

2007-01-01

Previous research found that operators prefer to have status, alerts, and controls located on the same screen. Unfortunately, that research was done with displays that were not designed specifically for collocation. In this experiment, twelve subjects evaluated two displays specifically designed for collocating system information against a baseline that consisted of dial status displays, a separate alert area, and a controls panel. These displays differed in the amount of collocation, pattern matching, and parameter movement compared to display size. During the data runs, subjects kept a randomly moving target centered on a display using a left-handed joystick and they scanned system displays to find a problem in order to correct it using the provided checklist. Results indicate that large parameter movement aided detection and then pattern recognition is needed for diagnosis but the collocated displays centralized all the information subjects needed, which reduced workload. Therefore, the collocated display with large parameter movement may be an acceptable display after familiarization because of the possible pattern recognition developed with training and its use.

Feasibility of eyes open alpha power training for mental enhancement in elite gymnasts.

PubMed

Dekker, Marian K J; van den Berg, Berber R; Denissen, Ad J M; Sitskoorn, Margriet M; van Boxtel, Geert J M

2014-01-01

This study focuses on a novel, easy to use and instruction-less method for mental training in athletes. Previous findings suggest that particular mental capacities are needed for achieving peak performance; including attentional control, focus, relaxation and positive affect. Electroencephalography (EEG) alpha brain activity has been associated with neural inhibition during processes of selective attention, for improving efficiency in information processing. Here we hypothesised that eyes open alpha power training by music teaches athletes to (1) learn to self-regulate their brain activity, and (2) learn to increase their baseline alpha power, herewith improving mental capacities such as focusing the allocation of attention. The study was double-blind and placebo-controlled. Twelve elite gymnasts were either given eyes open alpha power training or random beta power training (controls). Results indicate small improvements in sleep quality, mental and physical shape. In our first attempt at getting a grip on mental capacities in athletes, we think this novel training method can be promising. Because gymnastics is one of the most mentally demanding sports, we value even small benefits for the athlete and consider them indicative for future research.

The Effects of Acute Dopamine Precursor Depletion on the Cognitive Control Functions of Performance Monitoring and Conflict Processing: An Event-Related Potential (ERP) Study.

PubMed

Larson, Michael J; Clayson, Peter E; Primosch, Mark; Leyton, Marco; Steffensen, Scott C

2015-01-01

Studies using medications and psychiatric populations implicate dopamine in cognitive control and performance monitoring processes. However, side effects associated with medication or studying psychiatric groups may confound the relationship between dopamine and cognitive control. To circumvent such possibilities, we utilized a randomized, double-blind, placebo-controlled, within-subjects design wherein participants were administered a nutritionally-balanced amino acid mixture (BAL) and an amino acid mixture deficient in the dopamine precursors tyrosine (TYR) and phenylalanine (PHE) on two separate occasions. Order of sessions was randomly assigned. Cognitive control and performance monitoring were assessed using response times (RT), error rates, the N450, an event-related potential (ERP) index of conflict monitoring, the conflict slow potential (conflict SP), an ERP index of conflict resolution, and the error-related negativity (ERN) and error positivity (Pe), ERPs associated with performance monitoring. Participants were twelve males who completed a Stroop color-word task while ERPs were collected four hours following acute PHE and TYR depletion (APTD) or balanced (BAL) mixture ingestion in two separate sessions. N450 and conflict SP ERP amplitudes significantly differentiated congruent from incongruent trials, but did not differ as a function of APTD or BAL mixture ingestion. Similarly, ERN and Pe amplitudes showed significant differences between error and correct trials that were not different between APTD and BAL conditions. Findings indicate that acute dopamine precursor depletion does not significantly alter cognitive control and performance monitoring ERPs. Current results do not preclude the role of dopamine in these processes, but suggest that multiple methods for dopamine-related hypothesis testing are needed.

Randomized Controlled Trial of a MUFA or Fiber-Rich Diet on Hepatic Fat in Prediabetes

PubMed Central

Errazuriz, Isabel; Dube, Simmi; Slama, Michael; Visentin, Roberto; Nayar, Sunita; O’Connor, Helen; Cobelli, Claudio; Das, Swapan Kumar; Basu, Ananda; Kremers, Walter Karl; Port, John

2017-01-01

Context: Increased prevalence of type 2 diabetes mellitus and prediabetes worldwide is attributed in part to an unhealthy diet. Objective: To evaluate whether 12 weeks of high monounsaturated fatty acid (MUFA) or fiber-rich weight-maintenance diet lowers hepatic fat and improves glucose tolerance in people with prediabetes. Design: Subjects underwent a [6, 6-2H2]–labeled 75-g oral glucose tolerance test to estimate hepatic insulin sensitivity and liver fat fraction (LFF) using magnetic resonance spectroscopy before and after intervention. Setting: Mayo Clinic Clinical Research Trials Unit. Participants: 43 subjects with prediabetes. Intervention: Subjects were randomized into three isocaloric weight-maintaining diets containing MUFA (olive oil), extra fiber, and standard US food (control-habitual diet). Outcome Measures: LFF, glucose tolerance, and indices of insulin action and secretion. Results: Body weight was maintained constant in all groups during the intervention. Glucose and hormonal concentrations were similar in all groups before, and unchanged after, 12 weeks of intervention. LFF was significantly lower after intervention in the MUFA group (P < 0.0003) but remained unchanged in the fiber (P = 0.25) and control groups (P = 0.45). After 12 weeks, LFF was significantly lower in the MUFA than in the control group (P = 0.01), but fiber and control groups did not differ (P = 0.41). Indices of insulin action and secretion were not significantly different between the MUFA and control groups after intervention (P ≥ 0.11), but within-group comparison showed higher hepatic (P = 0.01) and total insulin sensitivity (P < 0.04) with MUFA. Conclusions: Twelve weeks of a MUFA diet decreases hepatic fat and improves both hepatic and total insulin sensitivity. PMID:28323952

Do catheter washouts extend patency time in long-term indwelling urethral catheters? A randomized controlled trial of acidic washout solution, normal saline washout, or standard care.

PubMed

Moore, Katherine N; Hunter, Kathleen F; McGinnis, Rosemary; Bacsu, Chasta; Fader, Mandy; Gray, Mikel; Getliffe, Kathy; Chobanuk, Janice; Puttagunta, Lakshmi; Voaklander, Donald C

2009-01-01

Blockage of long-term indwelling catheters with mineral deposit is an ongoing management issue, but evidence on optimal management is lacking. Our purpose was to examine whether catheter washouts prevent or reduce catheter blockage. A multisite randomized controlled trial. Adults with long-term indwelling catheters that required changing every 3 weeks or less, living in the community, and requiring supportive or continuing care were recruited. Participants were randomly assigned to 1 of 3 groups: control (usual care, no washout), saline washout, or commercially available acidic washout solution (Contisol Maelor Pharmaceuticals Ltd, Wrexham, UK). At baseline visit, the catheter was changed and participants were followed weekly for 8 weeks, with checks for catheter patency and urine pH. Participants randomized to saline or commercial solution had a weekly washout with the appropriate solution. Endpoints were 8 weeks (completion data), 3 or more catheter changes in the 8-week period, or symptomatic urinary tract infection (UTI) requiring antibiotics. The study hypothesis was that catheter life would be extended by 25% in the commercial solution group. It was not possible to blind participants or research nurses to washout versus no intervention, but participants in the saline and washout solution groups were blinded to solution type. One hundred twelve potential participants were screened; 73 were enrolled, randomized, and included in the final analysis. Of these, 53 completed the full 8 weeks of data collection; 16 terminated early because of 3 catheter changes or self-reported 'UTI'. Other reasons for termination were hematuria, latex sensitivity, deceased/severe illness, or personal choice. Analysis of variance was used to analyze mean differences on demographic variables and mean number of weeks in study. Kaplan-Meier survival curve analysis showed no statistical difference between the groups in time to first catheter change. At this time, the evidence is insufficient to state whether catheter washout with saline or Contisol is more effective than usual care with no washout in preventing blocking. No increased risk of UTI was associated with washout regimes.

Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn’s Disease: A Randomized Controlled Clinical Trial

PubMed Central

Zhang, Jian; Lv, Samei; Liu, Xiaojing; Song, Bin; Shi, Liping

2018-01-01

Background/Aims Stem cell therapy has been applied to treat a variety of autoimmune diseases, including Crohn’s disease (CD), but few studies have examined the use of umbilical cord mesenchymal stem cells (UC-MSCs). This trial sought to investigate the efficacy and safety of UC-MSCs for the treatment of CD. Methods Eighty-two patients who had been diagnosed with CD and had received steroid maintenance therapy for more than 6 months were included in this study. Forty-one patients were randomly selected to receive a total of four peripheral intravenous infusions of 1×106 UC-MSCs/kg, with one infusion per week. Patients were followed up for 12 months. The Crohn’s disease activity index (CDAI), Harvey-Bradshaw index (HBI), and corticosteroid dosage were assessed. Results Twelve months after treatment, the CDAI, HBI, and corticosteroid dosage had decreased by 62.5±23.2, 3.4±1.2, and 4.2±0.84 mg/day, respectively, in the UC-MSC group and by 23.6±12.4, 1.2±0.58, and 1.2±0.35 mg/day, respectively, in the control group (p<0.01, p<0.05, and p<0.05 for UC-MSC vs control, respectively). Four patients developed a fever after cell infusion. No serious adverse events were observed. Conclusions UC-MSCs were effective in the treatment of CD and produced mild side effects. PMID:28873511

Prevention and Treatment of White Spot Lesions During and After Treatment with Fixed Orthodontic Appliances: a Systematic Literature Review

PubMed Central

Lopatiene, Kristina; Lapenaite, Egle

2016-01-01

ABSTRACT Objectives The aim of the systematic literature review is to update the evidence for the prevention of white spot lesions, using materials containing fluoride and/or casein phosphopeptide-amorphous calcium phosphate during and after treatment with fixed orthodontic appliances. Material and Methods Information search for controlled studies on humans published between January 2008 and February 2016 was performed in PubMed, ScienceDirect, Embase, The Cochrane Library. Inclusion criteria were: the English language, study on humans, patients undergoing orthodontic treatment with fixed appliances, randomized or quasi-randomized controlled clinical studies fluoride-containing product or casein derivates used throughout the appliance therapy or straightaway after debonding. Results 326 articles were reviewed (Embase 141, PubMed 129, ScienceDirect 41, Cochrane 15). Twelve clinical studies fulfilled all inclusion criteria. Use of fluoridated toothpaste had a remineralizing effect on white spot lesions (WSLs) (P < 0.05); fluoride varnish and casein supplements were effective in prevention and early treatment of WSLs (P < 0.05). Conclusions Early detection of white spot lesions during orthodontic treatment would allow implementing preventive measures to control the demineralization process before lesions progress. The systemic review has showed that the usage of fluoride and casein supplements in ameliorating white spot lesions during and after fixed orthodontic treatment is significantly effective. However the use of casein phosphopeptide-amorphous calcium phosphate can be more beneficial than fluoride rinse in the reduction of demineralization spots. PMID:27489605

Effectiveness of Stress Management Skill Training on the Depression, Anxiety and Stress Levels in Drug Addicts after Drug Withdrawal

PubMed Central

Habibi, Zahra; Tourani, Somayeh; Sadeghi, Hasan; Abolghasemi, Abbass

2013-01-01

Background Stressful life events may cause initiation of drug use among people. The main purpose of this study was to evaluate the effectiveness of stress management skill training on depression, anxiety and stress levels in drug addicts after withdrawal. Objectives The population included all drug addicts after withdrawal in 2012 in Alborz province. Materials and Methods The study was quasi-experimental with pretest-posttest design with a control group. Levels of emotional reactions (depression, anxiety and stress) in all referrals to a counseling center for drug withdrawal in 2012 using the Depression, Anxiety, Stress (DASS-21) questionnaire was assessed. The study population included drug addicts after withdrawal. The sampling method was available sampling and random assignment. Thirty people who had higher emotional reactions were randomly selected and divided into two test (n = 15) and control (n = 15) groups. For the test group, a stress management skill training course was held in twelve 90-minute sessions, but the control group received no intervention. The obtained data were analyzed using SPSS-19 software with analysis of covariance. Results The results showed that stress management skill training has a significant effect on reducing emotional reactions (P < 0.01). It was noted that after 2 months test group follow-up, stress management training has retained its effect. Conclusion Apparently, training addicts about life skills, particularly stress management seems to be a good idea. PMID:24971280

Factors related to reduction in the consumption of fast food: application of the theory-based approaches.

PubMed

Zeinab, Jalambadani; Gholamreza, Garmaroudi; Mehdi, Yaseri; Mahmood, Tavousi; Korush, Jafarian

2017-09-21

The Trans-Theoretical model (TTM) and Theory of Planned Behaviour (TPB) may be promising models for understanding and predicting reduction in the consumption of fast food. The aim of this study was to examine the applicability of the Trans-Theoretical model (TTM) and the additional predictive role of the subjective norms and perceived behavioural control in predicting reduction consumption of fast food in obese Iranian adolescent girls. A cross sectional study design was conducted among twelve randomly selected schools in Sabzevar, Iran from 2015 to 2017. Four hundred eighty five randomly selected students consented to participate in the study. Hierarchical regression models used to predict the role of important variables that can influence the reduction in the consumption of fast food among students. using SPSS version 22. Variables Perceived behavioural control (r=0.58, P<0.001), Subjective norms (r=0.51, P<0.001), self-efficacy (r=0.49, P<0.001), decisional balance (pros) (r=0.29, P<0.001), decisional balance (cons) (r=0.25, P<0.001), stage of change (r=0.38, P<0.001), were significantly and positively correlated while experiential processes of change (r=0.08, P=0.135) and behavioural processes of change (r=0.09, P=0.145), were not significant. The study demonstrated that the TTM (except the experiential and behavioural processes of change) focusing on the perceived behavioural control and subjective norms are useful models for reduction in the consumption of fast food.

Twelve-Month Physical Activity Outcomes in Latinas in the Seamos Saludables Trial

PubMed Central

Marcus, Bess H.; Dunsiger, Shira I.; Pekmezi, Dori; Larsen, Britta A.; Marquez, Becky; Bock, Beth C.; Gans, Kim M.; Morrow, Kathleen M.; Tilkemeier, Peter

2017-01-01

Background Physical activity interventions designed for Latinas have shown short-term behavior change, but longer-term change and maintenance is rarely measured. Purpose To assess physical activity change at 12 months, following 6-month tapered completion of a randomized controlled trial of a physical activity intervention for Latinas. Methods Two hundred sixty-six underactive (<60 minutes/week physical activity) Latinas were randomized to an individually tailored, culturally and linguistically adapted physical activity intervention, or a wellness contact control. Participants received the materials through the mail for 6 months, then received booster doses at 8, 10, and 12 months. Minutes per week of moderate to vigorous physical activity were measured by the 7-Day Physical Activity Recall interview at baseline and 6 and 12 months. Data were collected at Brown University between 2009 and 2013, and analyses were conducted in 2013. Results At 12 months, increases in moderate to vigorous physical activity were significantly greater in the intervention than in the wellness group (mean difference=52 minutes/week, SE=9.38, p<0.01), with both groups showing slight increases in moderate to vigorous physical activity from 6 to 12 months. Intervention participants were also more likely to meet national moderate to vigorous physical activity guidelines (OR=3.14, p=0.01). Conclusions The intervention was more effective than the wellness control at 12 months, and physical activity increases from baseline to 6 months were maintained, suggesting the intervention may lead to sustainable behavior change. PMID:25442225

Effectiveness of a theory-based intervention to increase colorectal cancer screening among Iranian health club members: a randomized trial.

PubMed

Salimzadeh, Hamideh; Eftekhar, Hassan; Majdzadeh, Reza; Montazeri, Ali; Delavari, Alireza

2014-10-01

Colorectal cancer is the third most commonly diagnosed cancer and the fourth leading cause of death in the world. There are few published studies that have used theory-based interventions designed to increase colorectal cancer screening in community lay health organizations. The present study was guided by the theoretical concepts of the preventive health model. Twelve health clubs of a municipal district in Tehran were randomized to two study groups with equal ratio. The control group received usual services throughout the study while the intervention group also received a theory-based educational program on colorectal cancer screening plus a reminder call. Screening behavior, the main outcome, was assessed 4 months after randomization. A total of 360 members aged 50 and older from 12 health clubs completed a baseline survey. Participants in the intervention group reported increased knowledge of colorectal cancer and screening tests at 4 months follow-up (p's < .001). Moreover, exposure to the theory-based intervention significantly improved self-efficacy, perceived susceptibility, efficacy of screening, social support, and intention to be screened for colorectal cancer, from baseline to 4 months follow-up (p's < .001). The screening rate for colorectal cancer was significantly higher in the intervention group compared to the control group (odds ratio = 15.93, 95% CI = 5.57, 45.53). Our theory-based intervention was found to have a significant effect on colorectal cancer screening use as measured by self-report. The findings could have implications for colorectal cancer screening program development and implementation in primary health care settings and through other community organizations.

Prospective, randomized, controlled trial using best-selling smoking-cessation book.

PubMed

Foshee, James P; Oh, Anita; Luginbuhl, Adam; Curry, Joseph; Keane, William; Cognetti, David

2017-07-01

Our prospective, randomized, controlled trial aimed to evaluate the efficacy of the self-help book, The Easy Way to Stop Smoking, by Allen Carr, in promoting smoking cessation in patients with head and neck cancer. We assessed active smokers for their willingness to read a smoking cessation book. Participants were randomized to either receive the book from our department or recommended to purchase the book. All patients received smoking cessation counseling at recruitment. Phone surveys were conducted at short- and long-term intervals to determine if the patients had purchased and/or read the book and whether they were still smoking. One hundred twelve patients were recruited, 52 of whom completed follow-up surveys. Those who received the book for free were more likely to read the book (p = 0.05). Reading the book did not correlate with successful smoking cessation (p = 0.81). Some 26% of the 27 patients who received the book quit smoking compared with 32% of the 25 patients who were recommended the book (p = 0.76). Patients who indicated motivation to quit smoking were more likely to succeed. In our study, smoking cessation did not appear to be influenced by reading The Easy Way to Stop Smoking. Despite 80.8% of the cohort indicating at least a readiness to quit smoking at recruitment, only 28.8% of patients managed to achieve successful smoking cessation at long-term follow-up. Patient motivation remains an important factor in achieving long-term smoking abstinence. Quitting smoking remains a daunting challenge for patients, with multiple interventions likely needed to achieve cessation.

"EXHALE": exercise as a strategy for rehabilitation in advanced stage lung cancer patients: a randomized clinical trial comparing the effects of 12 weeks supervised exercise intervention versus usual care for advanced stage lung cancer patients.

PubMed

Quist, Morten; Langer, Seppo W; Rørth, Mikael; Christensen, Karl Bang; Adamsen, Lis

2013-10-14

Lung cancer is the leading cause of cancer death in North America and Western Europe. Patients with lung cancer in general have reduced physical capacity, functional capacity, poor quality of life and increased levels of anxiety and depression. Intervention studies indicate that physical training can address these issues. However, there is a lack of decisive evidence regarding the effect of physical exercise in patients with advanced lung cancer. The aim of this study is to evaluate the effects of a twelve weeks, twice weekly program consisting of: supervised, structured training in a group of advanced lung cancer patients (cardiovascular and strength training, relaxation). A randomized controlled trial will test the effects of the exercise intervention in 216 patients with advanced lung cancer (non-small cell lung cancer (NSCLC) stage IIIb-IV and small cell lung cancer (SCLC) extensive disease (ED)). Primary outcome is maximal oxygen uptake (VO₂peak). Secondary outcomes are muscle strength (1RM), functional capacity (6MWD), lung capacity (Fev1) and patient reported outcome (including anxiety, depression (HADS) and quality of life (HRQOL)). The present randomized controlled study will provide data on the effectiveness of a supervised exercise intervention in patients receiving systemic therapy for advanced lung cancer. It is hoped that the intervention can improve physical capacity and functional level, during rehabilitation of cancer patients with complex symptom burden and help them to maintain independent function for as long as possible. http://ClinicalTrials.gov, NCT01881906.

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

PubMed

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

2017-07-01

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

NeoCart, an autologous cartilage tissue implant, compared with microfracture for treatment of distal femoral cartilage lesions: an FDA phase-II prospective, randomized clinical trial after two years.

PubMed

Crawford, Dennis C; DeBerardino, Thomas M; Williams, Riley J

2012-06-06

Despite introduction of autologous chondrocyte therapy for repair of hyaline articular cartilage injury in 1994, microfracture remains a primary standard of care. NeoCart, an autologous cartilage tissue implant, was compared with microfracture in a multisite prospective, randomized trial of a tissue-engineered bioimplant for treating articular cartilage injuries in the knee. Thirty patients were randomized at a ratio of two to one (two were treated with an autologous cartilage tissue implant [NeoCart] for each patient treated with microfracture) at the time of arthroscopic confirmation of an International Cartilage Repair Society (ICRS) grade-III lesion(s). Microfracture or cartilage biopsy was performed. NeoCart, produced by seeding a type-I collagen matrix scaffold with autogenous chondrocytes and bioreactor treatment, was implanted six weeks following arthroscopic cartilage biopsy. Standard evaluations were performed with validated clinical outcomes measures. Three, six, twelve, and twenty-four-month data are reported. The mean duration of follow-up (and standard deviation) was 26 ± 2 months. There were twenty-one patients in the NeoCart group and nine in the microfracture group. The mean age (40 ± 9 years), body mass index (BMI) (28 ± 4 kg/m2), duration between the first symptoms and treatment (3 ± 5 years), and lesion size (287 ± 138 mm2 in the NeoCart group and 252 ± 135 mm2 in the microfracture group) were similar between the groups. Adverse event rates per procedure did not differ between the treatment arms. The scores on the Short Form-36 (SF-36), Knee Injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) scale, and International Knee Documentation Committee (IKDC) form improved from baseline (p < 0.05) to two years postoperatively in both treatment groups. In the NeoCart group, improvement, compared with baseline, was significant (p < 0.05) for all measures at six, twelve, and twenty-four months. Improvement in the NeoCart group was significantly greater (p < 0.05) than that in the microfracture group for the KOOS pain score at six, twelve, and twenty-four months; the KOOS symptom score at six months; the IKDC, KOOS sports, and visual analog scale (VAS) pain scores at twelve and twenty-four months; and the KOOS quality of life (QOL) score at twenty-four months. Analysis of covariance (ANCOVA) at one year indicated that the change in the KOOS pain (p = 0.016) and IKDC (p = 0.028) scores from pretreatment levels favored the NeoCart group. Significantly more NeoCart-treated patients (p = 0.0125) had responded to therapy (were therapeutic responders) at six months (43% versus 25% in the microfracture group) and twelve months (76% versus 22% in the microfracture group). This trend continued, as the proportion of NeoCart-treated patients (fifteen of nineteen) who were therapeutic responders at twenty-four months was greater than the proportion of microfracture-treated participants (four of nine) who were therapeutic responders at that time. This randomized study suggests that the safety of autologous cartilage tissue implantation, with use of the NeoCart technique, is similar to that of microfracture surgery and is associated with greater clinical efficacy at two years after treatment.

Cost-effectiveness of CBT, SSRI, and CBT+SSRI in the treatment for panic disorder.

PubMed

van Apeldoorn, F J; Stant, A D; van Hout, W J P J; Mersch, P P A; den Boer, J A

2014-04-01

The objective of this study was to assess the cost-effectiveness of three empirically supported treatments for panic disorder with or without agoraphobia: cognitive behavioral therapy (CBT), pharmacotherapy using a selective serotonin reuptake inhibitor (SSRI), or the combination of both (CBT+SSRI). Cost-effectiveness was examined based on the data from a multicenter randomized controlled trial. The Hamilton Anxiety Rating Scale was selected as a primary health outcome measure. Data on costs from a societal perspective (i.e., direct medical, direct non-medical, and indirect non-medical costs) were collected in the study sample (N=150) throughout a 24-month period in which patients received active treatment during the first twelve months and were seen twice for follow-up in the next twelve months. Total costs were largely influenced by costs of the interventions and productivity losses. The mean total societal costs were lower for CBT as compared to SSRI and CBT+SSRI. Costs of medication use were substantial for both SSRI and CBT+SSRI. When examining the balance between costs and health outcomes, both CBT and CBT+SSRI led to more positive outcomes than SSRI. Cognitive behavioral therapy is associated with the lowest societal costs. Cognitive behavioral therapy and CBT+SSRI are more cost-effective treatments for panic disorder with or without agoraphobia as compared to SSRI only. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The effectiveness of ultrabrief and brief educational videos for training lay responders in hands-only cardiopulmonary resuscitation: implications for the future of citizen cardiopulmonary resuscitation training.

PubMed

Bobrow, Bentley J; Vadeboncoeur, Tyler F; Spaite, Daniel W; Potts, Jerald; Denninghoff, Kurt; Chikani, Vatsal; Brazil, Paula R; Ramsey, Bob; Abella, Benjamin S

2011-03-01

Bystander cardiopulmonary resuscitation (CPR) improves survival from out-of-hospital cardiac arrest (OHCA) but often is not performed. We hypothesized that subjects viewing very short Hands-Only CPR videos will (1) be more likely to attempt CPR in a simulated OHCA scenario and (2) demonstrate better CPR skills than untrained individuals. This study is a prospective trial of 336 adults without recent CPR training randomized into 4 groups: (1) control (no training) (n=51); (2) 60-second video training (n=95); (3) 5-minute video training (n=99); and (4) 8-minute video training, including manikin practice (n=91). All subjects were tested for their ability to perform CPR during an adult OHCA scenario using a CPR-sensing manikin and Laerdal PC SkillReporting software. One half of the trained subjects were randomly assigned to testing immediately and the other half after a 2-month delay. Twelve (23.5%) controls did not even attempt CPR, which was true of only 2 subjects (0.7%; P=0.01) from any of the experimental groups. All experimental groups had significantly higher average compression rates (closer to the recommended 100/min) than the control group (P<0.001), and all experimental groups had significantly greater average compression depth (>38 mm) than the control group (P<0.0001). Laypersons exposed to very short Hands-Only CPR videos are more likely to attempt CPR and show superior CPR skills than untrained laypersons. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT01191736.

Interventions to reduce postpartum stress in first-time mothers: a randomized-controlled trial.

PubMed

Osman, Hibah; Saliba, Matilda; Chaaya, Monique; Naasan, Georges

2014-10-15

The postpartum period can be a challenging time particularly for first-time mothers. This study aimed to assess two different interventions designed to reduce stress in the postpartum among first-time mothers. Healthy first-time mothers with healthy newborns were recruited from hospitals in Beirut, Lebanon after delivery. The two interventions were a 20-minute film addressing common stressors in the postpartum period and a 24-hour telephone support hotline. Participants were randomized to one of four study arms to receive either the postpartum support film, the hotline service, both interventions, or a music CD (control). Participants were interviewed at eight to twelve weeks postpartum for assessment of levels of stress as measured by the Cohen Perceived Stress Scale (PSS-10). Of the 632 eligible women, 552 (88%) agreed to participate in the study. Of those, 452 (82%) completed the study. Mean PSS-10 scores of mothers who received the film alone (15.76) or the film with the hotline service (15.86) were significantly lower than that of the control group (18.93) (p-value <0.01). Among mothers who received the hotline service alone mean PSS-10 score (16.98) was also significantly lower than that of the control group (p-value <0.05). Both our postpartum support film and the 24-hour telephone hotline service reduced stress in the postpartum period in first-time mothers. These simple interventions can be easily implemented and could have an important impact on the mental wellbeing of new mothers. The trial was registered with clinicaltrials.gov (identifier # NCT00857051) on March 5, 2009.

Rationale and design of a randomized controlled trial examining the effect of classroom-based physical activity on math achievement.

PubMed

Have, Mona; Nielsen, Jacob Have; Gejl, Anne Kær; Thomsen Ernst, Martin; Fredens, Kjeld; Støckel, Jan Toftegaard; Wedderkopp, Niels; Domazet, Sidsel Louise; Gudex, Claire; Grøntved, Anders; Kristensen, Peter Lund

2016-04-11

Integration of physical activity (PA) into the classroom may be an effective way of promoting the learning and academic achievement of children at elementary school. This paper describes the research design and methodology of an intervention study examining the effect of classroom-based PA on mathematical achievement, creativity, executive function, body mass index and aerobic fitness. The study was designed as a school-based cluster-randomized controlled trial targeting schoolchildren in 1st grade, and was carried out between August 2012 and June 2013. Eligible schools in two municipalities in the Region of Southern Denmark were invited to participate in the study. After stratification by municipality, twelve schools were randomized to either an intervention group or a control group, comprising a total of 505 children with mean age 7.2 ± 0.3 years. The intervention was a 9-month classroom-based PA program that involved integration of PA into the math lessons delivered by the schools' math teachers. The primary study outcome was change in math achievement, measured by a 45-minute standardized math test. Secondary outcomes were change in executive function (using a modified Eriksen flanker task and the Behavior Rating Inventory of Executive Function (BRIEF) questionnaire filled out by the parents), creativity (using the Torrance Tests of Creative Thinking, TTCT), aerobic fitness (by the Andersen intermittent shuttle-run test) and body mass index. PA during math lessons and total PA (including time spent outside school) were assessed using accelerometry. Math teachers used Short Message Service (SMS)-tracking to report on compliance with the PA intervention and on their motivation for implementing PA in math lessons. Parents used SMS-tracking to register their children's PA behavior in leisure time. The results of this randomized controlled trial are expected to provide schools and policy-makers with significant new insights into the potential of classroom-based PA to improve cognition and academic achievement in children. Clinicaltrials.gov: NCT02488460 (06/29/2015).

Daily-Life Vocabulary: A Cinderella Component in Iranian High School Context

ERIC Educational Resources Information Center

Aminifard, Yasser; Askari, Hamdollah; Khajehei, Hassan

2015-01-01

This study reports on investigating the difference between Iranian high school students' performance on Academic Word (AW) and Daily-Life Word (DLW) tests. To this end, a number of 120 male senior high school students were randomly selected from twelve high schools in Gachsaran to serve as the participants of the study. Two multiple-choice tests,…

Improving Attitudes towards Children with Disabilities in a School Context: A Cluster Randomized Intervention Study

ERIC Educational Resources Information Center

Godeau, Emmanuelle; Vignes, Celine; Sentenac, Mariane; Ehlinger, Virginie; Navarro, Felix; Grandjean, Helene; Arnaud, Catherine

2010-01-01

Aim: Although inclusive education of disabled children is now an accepted practice, it is often challenged by negative peer attitudes. We undertook an interventional study aimed at improving students' attitudes towards their disabled peers. Method: The participants were students from the 7th grade of twelve paired schools (1509 students from 62…

Effect of dietary crude protein and forage contents on enteric methane emissions and nitrogen excretion from dairy cows simultaneously

USDA-ARS?s Scientific Manuscript database

The study aimed to examine, simultaneously, the effects of changing dietary forage and crude protein (CP) contents on methane (CH4) emissions and nitrogen (N) excretion from lactating dairy cows. Twelve post-peak lactating Holstein cows were randomly assigned to 4 treatments from a 2×2 factorial arr...

Effects of mechanical-bed massage on exercise-induced back fatigue in athletes.

PubMed

Zhong, Houyong; Eungpinichpong, Wichai; Wang, Xingze; Chatchawan, Uraiwon; Wanpen, Sawitri; Buranruk, Orawan

2018-03-01

[Purpose] The study aimed to preliminarily investigate the effects of mechanical-bed massage on exercise-induced back fatigue in athletes. [Subjects and Methods] Twelve male college athletes, randomly allocated to experimental or control groups, were instructed to perform reverse sit-up for 8 sessions until they became fatigued. The experimental group received a 20-min mechanical-bed massage session, while the control group rested on a bed for the same period of time. Visual Analogue Scale (VAS) on perceived back muscle fatigue, back muscle endurance, and Heart Rate Variability (HRV) parameters including stress index (SI), HRV index, SDNN, RMSSD, pNN50, LF, HF, and LF/HF were analyzed. [Results] Immediately and 24 hours after the intervention, the VAS significantly differed between the groups. Experimental group's HF was significantly higher immediately after the intervention than control group. Experimental group's LF and LF/HF were significantly lower immediately after the intervention than the control group. [Conclusion] Mechanical bed massage may help athletes overcome the subjective feelings of exercise-induced fatigue, modulate the automatic nervous system activity, especially for balancing sympathetic and parasympathetic activities. Therefore, mechanical bed massage may facilitate recovery from muscle and central fatigue after athlete training or competition.

Polydeoxyribonucleotide improves wound healing of fractional laser resurfacing in rat model.

PubMed

Yu, Mi; Lee, Jun Young

2017-02-01

Polydeoxyribonucleotide (PDRN) is an active compound that can promote wound healing. PDRN stimulates wound healing by enhancing angiogenesis and increasing fibroblast growth rates. Laser skin resurfacing is a popular cosmetic procedure for skin rejuvenation. Despite excellent improvement of photo-damaged skin and acne scarring, it is accompanied with drawbacks, such as prolonged erythema and crusting. This study was designed to assess the effect of PDRN on wounds induced by fractional laser resurfacing. Twelve male rats aged 8 weeks were randomly assigned to the PDRN treatment group and the control group. Wounds were induced using a fractional ablative CO 2 laser. The treatment group received daily injections of PDRN and the control group received injections of the vehicle. Wound healing assessed by clinical features and histopathologic findings. The process of wound healing was faster in the treatment group than in the control group. In the histopathological examination, the granulation tissue thickness score of the treatment group was significantly higher than that of the control group. Results of immunohistochemical staining showed a marked increase of VEGF-positive cells and PECAM-1/CD31-positive microvessels in the treatment group. PDRN may be a beneficial option to promote wound healing after laser treatment.

Effects of mechanical-bed massage on exercise-induced back fatigue in athletes

PubMed Central

Zhong, Houyong; Eungpinichpong, Wichai; Wang, Xingze; Chatchawan, Uraiwon; Wanpen, Sawitri; Buranruk, Orawan

2018-01-01

[Purpose] The study aimed to preliminarily investigate the effects of mechanical-bed massage on exercise-induced back fatigue in athletes. [Subjects and Methods] Twelve male college athletes, randomly allocated to experimental or control groups, were instructed to perform reverse sit-up for 8 sessions until they became fatigued. The experimental group received a 20-min mechanical-bed massage session, while the control group rested on a bed for the same period of time. Visual Analogue Scale (VAS) on perceived back muscle fatigue, back muscle endurance, and Heart Rate Variability (HRV) parameters including stress index (SI), HRV index, SDNN, RMSSD, pNN50, LF, HF, and LF/HF were analyzed. [Results] Immediately and 24 hours after the intervention, the VAS significantly differed between the groups. Experimental group’s HF was significantly higher immediately after the intervention than control group. Experimental group’s LF and LF/HF were significantly lower immediately after the intervention than the control group. [Conclusion] Mechanical bed massage may help athletes overcome the subjective feelings of exercise-induced fatigue, modulate the automatic nervous system activity, especially for balancing sympathetic and parasympathetic activities. Therefore, mechanical bed massage may facilitate recovery from muscle and central fatigue after athlete training or competition. PMID:29581653

[Efficacy and Safety Evaluation of Bushen Shuji Granule in Treating Ankylosing Spondylitis Patients: a Clinical Study].

PubMed

Kong, Wei-ping; Tao, Qing-wen; Zhang, Ying-ze; Yang, Shu; Xu, Yuan; Zhu, Xiao-xia; Jin, Yue; Yang, Wen-xue; Yan, Xiao-ping

2015-06-01

To evaluate the short-term efficacy and safety of Bushen Shuji Granule (BSG) in treating ankylosing spondylitis (AS) patients. A prospective randomized controlled clinical trial was carried out in 62 active stage AS patients with Shen deficiency Du-channel cold syndrome (SDDCS), who were randomly assigned to the BSG group (treated with BSG) and the control group (treated with Celecoxib Capsule). Twelve weeks consisted of one therapeutic course. Therapeutic effects were evaluated by ASAS20 and ASAS40 (set by Assessments in Ankylosing Spondylitis working group) , BASDA150, Chinese medical (CM) syndrome efficacy evaluation standards. BASDAI, the Bath Ankylosing Spondylitis Functional Index (BASFI), the Bath AS Metrology Index (BASMI), scores for spine pain, scores for pain at night, patient global assessment (PGA) , erythrocyte sedimentation rate (ESR) , and C reactive protein (CRP) were observed before and after treatment. After three-month treatment by BSG, ASAS20 standard rate was 63. 33% (19/30 cases) in the BSG group and 66.67% (20/30 cases) in the control group with no significant difference between the two groups (χ2 = 0.073, P > 0.05). The efficacy for CM syndromes was 70.00% (21/30 cases) in the BSG group, higher than that in the control group [40.00% (12/30 cases), χ2 = 5.455, P < 0.05]. Scores for CM syndromes, BASDAI, night pain index, spinal pain index, PGA, CRP were improved in the BSG group (P < 0.05, P < 0.01). The incidence of adverse events in the BSG group was lower than that of the control group. BSG based on Shen supplementing, Du-channel strengthening, blood activating, and channels dredging method had good short-term clinical efficacy and safety in treating AS.

Individual- versus group-based financial incentives for weight loss: a randomized, controlled trial.

PubMed

Kullgren, Jeffrey T; Troxel, Andrea B; Loewenstein, George; Asch, David A; Norton, Laurie A; Wesby, Lisa; Tao, Yuanyuan; Zhu, Jingsan; Volpp, Kevin G

2013-04-02

Data on the effectiveness of employer-sponsored financial incentives for employee weight loss are limited. To test the effectiveness of 2 financial incentive designs for promoting weight loss among obese employees. Randomized, controlled trial. (ClinicalTrials.gov: NCT01208350) Children's Hospital of Philadelphia. 105 employees with a body mass index between 30 and 40 kg/m2. 24 weeks of monthly weigh-ins (control group; n = 35); individual incentive, designed as $100 per person per month for meeting or exceeding weight-loss goals (n = 35); and group incentive, designed as $500 per month split among participants within groups of 5 who met or exceeded weight-loss goals (n = 35). Weight loss after 24 weeks (primary outcome) and 36 weeks and changes in behavioral mediators of weight loss (secondary outcomes). Group-incentive participants lost more weight than control participants (mean between-group difference, 4.4 kg [95% CI, 2.0 to 6.7 kg]; P < 0.001) and individual-incentive participants (mean between-group difference, 3.2 kg [CI, 0.9 to 5.5 kg]; P = 0.008). Twelve weeks after incentives ended and after adjustment for 3-group comparisons, group-incentive participants maintained greater weight loss than control group participants (mean between-group difference, 2.9 kg [CI, 0.5 to 5.3 kg]; P = 0.016) but not greater than individual-incentive participants (mean between-group difference, 2.7 kg [CI, 0.4 to 5.0 kg]; P = 0.024). Single employer and short follow-up. A group-based financial incentive was more effective than an individual incentive and monthly weigh-ins at promoting weight loss among obese employees at 24 weeks. National Institute on Aging.

Evaluation of the interdisciplinary PSYMEPHY treatment on patients with fibromyalgia: a randomized control trial.

PubMed

Martín, Josune; Torre, Fernando; Aguirre, Urko; González, Nerea; Padierna, Angel; Matellanes, Begoña; Quintana, José Ma

2014-04-01

Fibromyalgia (FM) is a chronic disorder that can have a devastating effect on patients' lives. This study assessed the efficacy of a 6-week interdisciplinary treatment that combines coordinated PSYchological, Medical, Educational, and PHYsiotherapeutic interventions (PSYMEPHY) compared with standard pharmacologic care. The study was a randomized controlled trial (54 participants in the PSYMEPHY group and 56 in the control group [CG] ) with follow-up at 6 months. PSYMEPHY patients were also assessed at 12 months. The main outcomes were changes in total Fibromyalgia Impact Questionnaire (FIQ) score, pain, fatigue, morning tiredness, anxiety, and use of pain coping strategies as measured by the FIQ, the visual analog scale, and the Coping with Chronic Pain Questionnaire. After the 6-month assessment, patients in the CG were offered the PSYMEPHY treatment, and completed all of the instruments immediately after treatment, and at 6- and 12-month follow-up visits (N = 93). Subjects received therapy at two different outpatient clinical locations. Fibromyalgia patients. Six months after the intervention, significant improvements in total FIQ score (P = 0.04), and pain (P = 0.03) were seen in the PSYMEPHY group compared with controls. Twelve months after the intervention, all patients in the PSYMEPHY group maintained statistically significant improvements in total FIQ score, and pain, and showed an improvement in fatigue, rested, anxiety, and current pain compared with baseline. Data from the control patients who underwent the PSYMEPHY intervention corroborated the initial results. This study highlights the beneficial effects of an interdisciplinary treatment for FM patients in a hospital pain management unit. A 6-week interdisciplinary intervention showed significant improvement in key domains of fibromyalgia, as quality of life, pain, fatigue, rested, and anxiety at 12 months. Wiley Periodicals, Inc.

An Analysis of Tower (Ground) Controller - Pilot Voice Communications

DOT National Transportation Integrated Search

1995-11-01

This report is based on an analysis of over 48 hours of pilot-controller communications recorded from the ground-control : frequency at twelve air traffic control towers. The analysis examined the complexity of controller instructions, that : is, how...

Twelve months effect of self-referral to inpatient treatment on patient activation, recovery, symptoms and functioning: A randomized controlled study.

PubMed

Moljord, I E O; Lara-Cabrera, M L; Salvesen, Ø; Rise, M B; Bjørgen, D; Antonsen, D Ø; Olsø, T M; Evensen, G H; Gudde, C B; Linaker, O M; Steinsbekk, A; Eriksen, L

2017-06-01

To investigate the effect of having a contract for self-referral to inpatient treatment (SRIT) in patients with severe mental disorders. A randomized controlled trial with 53 adult patients; 26 participants received a SRIT contract, which they could use to refer themselves into a Community Mental Health Centre up to five days for each referral without contacting a doctor in advance. Outcomes were assessed after 12 months with the self-report questionnaires Patient Activation Measure (PAM-13), Recovery Assessment Scale (RAS), and the Behavior and Symptom Identification Scale (BASIS-32) and analyzed using linear mixed and regression models. There was no significant effect on PAM-13 (estimated mean difference (emd) -0.41, 95% CI (CI):-7.49-6.67), nor on the RAS (emd 0.02, CI:-0.27-0.31) or BASIS-32 (0.09, CI:-0.28-0.45). An exploratory post hoc analysis showed effect of SRIT in those with low PAM below ≤47 (p=0.049). There were no group differences after 12 months, but both groups maintained their baseline levels. SRIT contracts can be recommended as it supports the rights to self-determination, promote user participation in decision-making in own treatment without any indication of adverse effects. Copyright © 2017 The Author(s). Published by Elsevier B.V. All rights reserved.

The Impact of Massage Therapy on Function in Pain Populations—A Systematic Review and Meta-Analysis of Randomized Controlled Trials: Part III, Surgical Pain Populations

PubMed Central

Boyd, Courtney; Crawford, Cindy; Paat, Charmagne F; Price, Ashley; Xenakis, Lea; Zhang, Weimin; Buckenmaier, Chester; Buckenmaier, Pamela; Cambron, Jerrilyn; Deery, Christopher; Schwartz, Jan; Werner, Ruth; Whitridge, Pete

2016-01-01

Abstract Objective Pain is multi-dimensional and may be better addressed through a holistic, biopsychosocial approach. Massage therapy is commonly practiced among patients seeking pain management; however, its efficacy is unclear. This systematic review and meta-analysis is the first to rigorously assess the quality of the evidence for massage therapy’s efficacy in treating pain, function-related, and health-related quality of life outcomes in surgical pain populations. Methods Key databases were searched from inception through February 2014. Eligible randomized controlled trials were assessed for methodological quality using SIGN 50 Checklist. Meta-analysis was applied at the outcome level. A professionally diverse steering committee interpreted the results to develop recommendations. Results Twelve high quality and four low quality studies were included in the review. Results indicate massage therapy is effective for treating pain [standardized mean difference (SMD) = −0.79] and anxiety (SMD = −0.57) compared to active comparators. Conclusion Based on the available evidence, weak recommendations are suggested for massage therapy, compared to active comparators for reducing pain intensity/severity and anxiety in patients undergoing surgical procedures. This review also discusses massage therapy safety, challenges within this research field, how to address identified research gaps, and next steps for future research. PMID:27165970

Effects of a Proprietary Freeze-Dried Water Extract of Eurycoma longifolia (Physta) and Polygonum minus on Sexual Performance and Well-Being in Men: A Randomized, Double-Blind, Placebo-Controlled Study

PubMed Central

Udani, Jay K.; George, Annie A.; Musthapa, Mufiza; Pakdaman, Michael N.; Abas, Azreena

2014-01-01

Background. Physta is a proprietary product containing a freeze-dried water extract of Eurycoma longifolia (tongkat ali), which is traditionally used as an energy enhancer and aphrodisiac. We aim to evaluate a 300 mg combination of Physta and Polygonum minus, an antioxidant, with regard to sexual performance and well-being in men. Methods. Men that aged 40–65 years were screened for this 12-week randomized, double-blind, placebo-controlled, parallel-group study. Outcome measures included validated questionnaires that aimed to evaluate erectile function, satisfaction with intervention, sexual intercourse performance, erectile hardness, mood, and overall quality of life. Results. 12 subjects in the active group and 14 in the placebo group completed the study. Significant improvements were noted in scores for the Sexual Intercourse Attempt diary, Erection Hardness Scale, Sexual Health Inventory of Men, and Aging Male Symptom scale (P < 0.05 for all). Three adverse events were reported in the active group and four in the placebo group, none of which were attributed to study product. Laboratory evaluations, including liver and kidney function testing, showed no clinically significant abnormality. Conclusion. Supplementation for twelve weeks with Polygonum minus and the proprietary Eurycoma longifolia extract, Physta, was well tolerated and more effective than placebo in enhancing sexual performance in healthy volunteers. PMID:24550993

Effects of a Proprietary Freeze-Dried Water Extract of Eurycoma longifolia (Physta) and Polygonum minus on Sexual Performance and Well-Being in Men: A Randomized, Double-Blind, Placebo-Controlled Study.

PubMed

Udani, Jay K; George, Annie A; Musthapa, Mufiza; Pakdaman, Michael N; Abas, Azreena

2014-01-01

Background. Physta is a proprietary product containing a freeze-dried water extract of Eurycoma longifolia (tongkat ali), which is traditionally used as an energy enhancer and aphrodisiac. We aim to evaluate a 300 mg combination of Physta and Polygonum minus, an antioxidant, with regard to sexual performance and well-being in men. Methods. Men that aged 40-65 years were screened for this 12-week randomized, double-blind, placebo-controlled, parallel-group study. Outcome measures included validated questionnaires that aimed to evaluate erectile function, satisfaction with intervention, sexual intercourse performance, erectile hardness, mood, and overall quality of life. Results. 12 subjects in the active group and 14 in the placebo group completed the study. Significant improvements were noted in scores for the Sexual Intercourse Attempt diary, Erection Hardness Scale, Sexual Health Inventory of Men, and Aging Male Symptom scale (P < 0.05 for all). Three adverse events were reported in the active group and four in the placebo group, none of which were attributed to study product. Laboratory evaluations, including liver and kidney function testing, showed no clinically significant abnormality. Conclusion. Supplementation for twelve weeks with Polygonum minus and the proprietary Eurycoma longifolia extract, Physta, was well tolerated and more effective than placebo in enhancing sexual performance in healthy volunteers.

Perturbation Training Can Reduce Community-Dwelling Older Adults’ Annual Fall Risk: A Randomized Controlled Trial

PubMed Central

Bhatt, Tanvi; Yang, Feng; Wang, Edward

2014-01-01

Background. Previous studies indicated that a single session of repeated-slip exposure can reduce over 40% of laboratory-induced falls among older adults. The purpose of this study was to determine to what degree such perturbation training translated to the reduction of older adults’ annual falls risk in their everyday living. Methods. Two hundred and twelve community-dwelling older adults (≥65 years old) were randomly assigned to either the training group (N = 109), who then were exposed to 24 unannounced repeated slips, or the control group (N = 103), who merely experienced one slip during the same walking in the same protective laboratory environment. We recorded their falls in the preceding year (through self-reported history) and during the next 12 months (through falls diary and monitored with phone calls). Results. With this single session of repeated-slip exposure, training cut older adults’ annual risk of falls by 50% (from 34% to 15%, p < .05). Those who experienced merely a single slip were 2.3 times more likely to fall during the same 12-month follow-up period (p < .05) than those who experienced the 24 repeated slips. Such training effect was especially prominent among those who had history of falls. Conclusion. A single session of repeated-slip exposure could improve community-dwelling older adults’ resilience to postural disturbances and, hence, significantly reduce their annual risk of falls. PMID:24966227

The Bipolar Depression Electrical Treatment Trial (BETTER): Design, Rationale, and Objectives of a Randomized, Sham-Controlled Trial and Data from the Pilot Study Phase

PubMed Central

Pereira Junior, Bernardo de Sampaio; Nunes, Paula; Benseñor, Isabela Martins; Lotufo, Paulo Andrade; Machado-Vieira, Rodrigo; Brunoni, André R.

2015-01-01

Background. Bipolar depression (BD) is a prevalent condition, with poor therapeutic options and a high degree of refractoriness. This justifies the development of novel treatment strategies, such as transcranial direct current stimulation (tDCS) that showed promising results in unipolar depression. Methods. We describe a randomized, sham-controlled, double-blinded trial using tDCS for refractory, acutely symptomatic BD (the bipolar depression electrical treatment trial, BETTER). Sixty patients will be enrolled and assessed with clinical and neuropsychological tests. The primary outcome is change (over time and across groups) in the scores of the Hamilton Depression Rating Scale (17 items). Biological markers such as blood neurotrophins and interleukins, genetic polymorphisms, heart rate variability, and motor cortical excitability will be assessed. Twelve anodal-left/cathodal-right 2 mA tDCS sessions over the dorsolateral prefrontal cortex will be performed in 6 weeks. Results. In the pilot phase, five patients received active tDCS and were double-blindly assessed, two presenting clinical response. TDCS was well-tolerated, with no changes in cognitive scores. Conclusion. This upcoming clinical trial will address the efficacy of tDCS for BD on different degrees of refractoriness. The evaluation of biological markers will also help in understanding the pathophysiology of BD and the mechanisms of action of tDCS. PMID:25878904

Effects of cobalt on membrane ATPases, oxidant, and antioxidant values in the cerebrum and cerebellum of suckling rats.

PubMed

Garoui, Elmouldi; Ben Amara, Ibtissem; Driss, Dorra; Elwej, Awatef; Chaabouni, Semia Ellouze; Boudawara, Tahia; Zeghal, Najiba

2013-09-01

Chronic overexposure to cobalt (Co) may result in neurotoxic effects, but the mechanism of Co-induced neurotoxicity is not yet well established. Our study was conducted to determine whether Co is associated to the induction of central nervous system damage in pregnant rats and their progeny. Twelve pregnant female rats were randomly divided into 2 groups: group I served as controls and group II received Co (350 mg/L, orally). Treatments started from the 14th day of pregnancy until day 14 after delivery. Co concentration in plasma was higher in the treated groups than in the controls. Exposure to Co also increased the levels of MDA, PCO, H2O2, and AOPP, while Na(+)K(+)-ATPase and Mg(2+)-ATPase, AChE, and BuChE activities decreased in the cerebrum and cerebellum of suckling pups. A smear without ladder formation on agarose gel was also shown in the cerebrum and cerebellum, indicating random DNA degradation. A reduction in GPx, SOD, CAT, GSH, NPSH, and vitamin C values was observed. The changes were confirmed by histological results. In conclusion, these data showed that the exposure of pregnant and lactating rats to Co resulted in the development of oxidative stress and the impairment of defense systems in the cerebrum and cerebellum of their suckling pups.

The Efficacy of Contingency Management on Cocaine Craving, using Prize-based Reinforcement of Abstinence in Cocaine Users.

PubMed

Pirnia, Bijan; Tabatabaei, Seyed Kazem Rasoulzadeh; Tavallaii, Abbas; Soleimani, Ali Akbar; Pirnia, Kambiz

2016-11-01

Contingency management (CM) is one of the most common therapies in the domain of drug addiction. This study has been carried out with the purpose of evaluating the efficacy of contingency management intervention. In an experimental design, between December 15, 2014 and November 20, 2015, fifty men (between 18 and 31 with an average age of 24.6) with a history of cocaine use, were selected voluntarily and were randomly assigned into two groups of CM and control group. The CM group were awarded coupons for negative urine tests, over a period of twelve weeks. The urine tests were taken from the participants twice per week, with cutoff concentrations for positive set at 300 ng/ml and self-reporting index of cocaine craving (response rate = 96%) were evaluated in two phase, through pretest and posttest measures. The data were analyzed by parametric covariance test. Additionally, the qualitative data, resulted from demographic measures, were coded and were analyzed with the help of an analysis instrument of qualitative data i.e. ATLAS.ti-5.2. The primary outcome was the number of negative urine tests and the secondary outcome included the cocaine usage craving index over twelve weeks. The mean of (95% of confidence) number of negative cocaine urine tests was 15.4 (13.1-17.8) in the CM group and 19.7 (17.7-21.6) in the control group (P = 0.049). Also, results showed that CM has a significant effect on reducing craving (p<0.01). The findings of this study, while having practical aspects in this domain, can be valuable in planning remedial procedures.

Adult human mesenchymal stem cells delivered via intra-articular injection to the knee following partial medial meniscectomy: a randomized, double-blind, controlled study.

PubMed

Vangsness, C Thomas; Farr, Jack; Boyd, Joel; Dellaero, David T; Mills, C Randal; LeRoux-Williams, Michelle

2014-01-15

There are limited treatment options for tissue restoration and the prevention of degenerative changes in the knee. Stem cells have been a focus of intense preclinical research into tissue regeneration but limited clinical investigation. In a randomized, double-blind, controlled study, the safety of the intra-articular injection of human mesenchymal stem cells into the knee, the ability of mesenchymal stem cells to promote meniscus regeneration following partial meniscectomy, and the effects of mesenchymal stem cells on osteoarthritic changes in the knee were investigated. A total of fifty-five patients at seven institutions underwent a partial medial meniscectomy. A single superolateral knee injection was given within seven to ten days after the meniscectomy. Patients were randomized to one of three treatment groups: Group A, in which patients received an injection of 50 × 10⁶ allogeneic mesenchymal stem cells; Group B, 150 × 10⁶ allogeneic mesenchymal stem cells; and the control group, a sodium hyaluronate (hyaluronic acid/hyaluronan) vehicle control. Patients were followed to evaluate safety, meniscus regeneration, the overall condition of the knee joint, and clinical outcomes at intervals through two years. Evaluations included sequential magnetic resonance imaging (MRI). No ectopic tissue formation or clinically important safety issues were identified. There was significantly increased meniscal volume (defined a priori as a 15% threshold) determined by quantitative MRI in 24% of patients in Group A and 6% in Group B at twelve months post meniscectomy (p = 0.022). No patients in the control group met the 15% threshold for increased meniscal volume. Patients with osteoarthritic changes who received mesenchymal stem cells experienced a significant reduction in pain compared with those who received the control, on the basis of visual analog scale assessments. There was evidence of meniscus regeneration and improvement in knee pain following treatment with allogeneic human mesenchymal stem cells. These results support the study of human mesenchymal stem cells for the apparent knee-tissue regeneration and protective effects.

A randomized trial of controlled-release oxycodone during inpatient rehabilitation following unilateral total knee arthroplasty.

PubMed

Cheville, A; Chen, A; Oster, G; McGarry, L; Narcessian, E

2001-04-01

Reliance on "as-needed" analgesia following total knee arthroplasty may lead to inadequate control of pain and delayed recovery of function. Preemptive use of controlled-release opioids may improve pain control, accelerate recovery, and reduce the need for inpatient rehabilitative services. This study was designed to determine whether controlled-release opioids enhance post-arthroplasty pain control and facilitate functional recovery during rehabilitation. Fifty-nine patients admitted for inpatient rehabilitation following unilateral total knee arthroplasty were randomized to receive OxyContin (controlled-release oxycodone) (twenty-nine patients) or a placebo (thirty patients) every twelve hours. Both groups could receive on-request, immediate-release oxycodone (5 mg every four hours). The dose of study medication was increased on the basis of the frequency of requests for immediate-release oxycodone. Measures of interest included pain ratings as determined with a visual-analog scale, changes in the range of motion of the knee and quadriceps strength, and improvements in selected Functional Independence Measure scores during the first eight physical therapy sessions. The duration of the hospital stay for rehabilitation also was compared between the two groups. Baseline demographic, clinical, and functional characteristics were similar between the OxyContin and placebo groups. Compared with the placebo group, the patients who received OxyContin reported significantly less pain as well as significantly greater range of motion of the knee (passive motion, p = 0.036; active motion, p< 0.001) and quadriceps strength (p = 0.001) by the eighth physical therapy session. The patients who received OxyContin also were discharged from the rehabilitation hospital at an average of 2.3 days earlier than the patients in the placebo group (p = 0.013). Preemptive use of controlled-release oxycodone during rehabilitation following total knee arthroplasty leads to improved pain control, more rapid functional recovery, and a reduced need for inpatient rehabilitative services.

Meta-Analysis of Drainage Versus No Drainage After Laparoscopic Cholecystectomy

PubMed Central

Lucarelli, Pierino; Di Filippo, Annalisa; De Angelis, Francesco; Stipa, Francesco; Spaziani, Erasmo

2014-01-01

Background and Objectives: Routine drainage after laparoscopic cholecystectomy is still controversial. This meta-analysis was performed to assess the role of drains in reducing complications in laparoscopic cholecystectomy. Methods: An electronic search of Medline, Science Citation Index Expanded, Scopus, and the Cochrane Library database from January 1990 to June 2013 was performed to identify randomized clinical trials that compare prophylactic drainage with no drainage in laparoscopic cholecystectomy. The odds ratio for qualitative variables and standardized mean difference for continuous variables were calculated. Results: Twelve randomized controlled trials were included in the meta-analysis, involving 1939 patients randomized to a drain (960) versus no drain (979). The morbidity rate was lower in the no drain group (odds ratio, 1.97; 95% confidence interval, 1.26 to 3.10; P = .003). The wound infection rate was lower in the no drain group (odds ratio, 2.35; 95% confidence interval, 1.22 to 4.51; P = .01). Abdominal pain 24 hours after surgery was less severe in the no drain group (standardized mean difference, 2.30; 95% confidence interval, 1.27 to 3.34; P < .0001). No significant difference was present with respect to the presence and quantity of subhepatic fluid collection, shoulder tip pain, parenteral ketorolac consumption, nausea, vomiting, and hospital stay. Conclusion: This study was unable to prove that drains were useful in reducing complications in laparoscopic cholecystectomy. PMID:25516708

Evaluation of Four Pulpotomy Techniques in Primary Molars: A Randomized Controlled Trial

PubMed Central

Ansari, Ghassem; Morovati, Seyyedeh Pouya; Asgary, Saeed

2018-01-01

Introduction: This trial was designed to evaluate the clinical and radiographic success rates of calcium-enriched mixture (CEM) cement with and without low level laser therapy (LLLT) and compare them to that of formocresol (FC) and ferric sulfate (FS) in primary molar pulpotomies. Methods and Materials: This randomized clinical trial was conducted on a total of 160 teeth selected from 40 patients aged 3-9 years. Patients with at least four primary molars needing pulpotomy, were included in order to have each tooth assigned randomly in one of the four following groups; FC, FS, CEM, and LLLT/CEM. Six- and twelve-month follow-up periods were conducted in order to enable a clinical and radiographic evaluation of the treated teeth. Collected data were analyzed using Cochran Q Tests. Results: The 12-month clinical success rate for each technique was: FC=100%, FS=95%, CEM=97.5% and LLLT/CEM=100% with no significant differences (P>0.05). Furthermore, 12-month radiographic success rate for each technique was: FC=100%, FS=92.5%, CEM=95% and LLLT/CEM=100% with no significant differences (P>0.05). Conclusion: Favorable outcomes of four treatment techniques in pulpotomy of primary molar teeth were comparable. CEM with/without LLLT may be considered as a safe and successful pulpotomy treatment modality compared to current conventional methods. PMID:29692828

Comparison of the Effectiveness of Two Forms of the Enhancing Relationships in School Communities Project for Promoting Cooperative Conflict Resolution Education in Australian Primary Schools

ERIC Educational Resources Information Center

Trinder, Margot; Wertheim, Eleanor H.; Freeman, Elizabeth; Sanson, Ann; Richardson, Shanel; Hunt, Sue

2010-01-01

This study evaluated the Enhancing Relationships in School Communities (ERIS) Project which aimed to promote constructive conflict resolution (CR) in Australian primary school communities through professional development for core teams of three-five staff (n = 33 teachers). Twelve schools were randomly assigned to a full intervention (FI) group or…

Comparative Study of Preconceived Scientific Ideas Held by Different Groups of Junior Secondary School Students in Niger State, Nigeria

ERIC Educational Resources Information Center

Mohammed, Babagana; Ahmed Emigilati, Mohammed; Ishiaku, Ibrahim

2016-01-01

This study investigates the preconceptions of junior secondary school students in Niger State on scientific ideas. The sample was made up of three hundred and sixty (360) junior secondary school students (JSSS I) who were randomly selected from twelve secondary schools. Four schools in each three educational zones with thirty (30) students from…

Reclamation of skid roads with fiber mats and native vegetation: effects on erosion

Treesearch

shawn T. Grushecky; David w. McGill; William Grafton; John Edwards; Lisa Tager

2007-01-01

A research study was established to test the effectiveness of fiber mats and native seed mixtures in reducing soil erosion from newly-constructed skid roads in the Elk River Watershed in central West Virginia. Twelve road sections of equal grade were paired with a randomly-selected section receiving a fiber mat and native grass seed while the other road section was not...

Does a Multi-Media Program Enhance Job Matching for a Population with Intellectual Disabilities? A Social Validity Study

ERIC Educational Resources Information Center

Michaud, Kim M.

2017-01-01

This dissertation describes a mixed method design study on the social validity of a multi-media job search tool, the YES tool, at a four-year Comprehensive Transition Program at an East Coast University. The participants included twelve students, randomly selected from those who, with their parents' assent, agreed to volunteer for this study…

The Employment Retention and Advancement Project: How Effective Are Different Approaches Aiming to Increase Employment Retention and Advancement? Final Impacts for Twelve Models. Executive Summary

ERIC Educational Resources Information Center

Hendra, Richard; Dillman, Keri-Nicole; Hamilton, Gayle; Lundquist, Erika; Martinson, Karin; Wavelet, Melissa

2010-01-01

This report summarizes the final impact results for the national Employment Retention and Advancement (ERA) project. This project tested, using a random assignment design, the effectiveness of numerous programs intended to promote steady work and career advancement. All the programs targeted current and former welfare recipients and other low-wage…

Mechanisms of efficacy of CBT for Cambodian refugees with PTSD: improvement in emotion regulation and orthostatic blood pressure response.

PubMed

Hinton, Devon E; Hofmann, Stefan G; Pollack, Mark H; Otto, Michael W

2009-01-01

Based on the results of a randomized controlled trial, we examined a model of the mechanisms of efficacy of culturally adapted cognitive-behavior therapy (CBT) for Cambodian refugees with pharmacology-resistant posttraumatic stress disorder (PTSD) and comordid orthostatic panic attacks (PAs). Twelve patients were in the initial treatment condition, 12 in the delayed treatment condition. The patients randomized to CBT had much greater improvement than patients in the waitlist condition on all psychometric measures and on one physiological measure-the systolic blood pressure response to orthostasis (d = 1.31)-as evaluated by repeated-measures MANOVA and planned contrasts. After receiving CBT, the Delayed Treatment Group improved on all measures, including the systolic blood pressure response to orthostasis. The CBT treatment's reduction of PTSD severity was significantly mediated by improvement in orthostatic panic and emotion regulation ability. The current study supports our model of the generation of PTSD in the Cambodian population, and suggests a key role of decreased vagal tone in the generation of orthostatic panic and PTSD in this population. It also suggests that vagal tone is involved in emotion regulation, and that both vagal tone and emotion regulation improve across treatment.

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

J. E. Lawson, R. Marsala, S. Ramakrishnan, X. Zhao, P. Sichta

In order to provide improved and expanded experimental capabilities, the existing Transrex power supplies at PPPL are to be upgraded and modernized. Each of the 39 power supplies consists of two six pulse silicon controlled rectifier sections forming a twelve pulse power supply. The first modification is to split each supply into two independent six pulse supplies by replacing the existing obsolete twelve pulse firing generator with two commercially available six pulse firing generators. The second change replaces the existing control link with a faster system, with greater capacity, which will allow for independent control of all 78 power supplymore » sections. The third change replaces the existing Computer Automated Measurement and Control (CAMAC) based fault detector with an Experimental Physics and Industrial Control System (EPICS) compatible unit, eliminating the obsolete CAMAC modules. Finally the remaining relay logic and interfaces to the "Hardwired Control System" will be replaces with a Programmable Logic Controller (PLC).« less

THE IMPACT OF SARCOPENIA ON A PHYSICAL ACTIVITY INTERVENTION: THE LIFESTYLE INTERVENTIONS AND INDEPENDENCE FOR ELDERS PILOT STUDY (LIFE-P)

PubMed Central

LIU, C.K.; LENG, X.; HSU, F.-C.; KRITCHEVSKY, S.B.; DING, J.; EARNEST, C.P.; FERRUCCI, L.; GOODPASTER, B.H.; GURALNIK, J.M.; LENCHIK, L.; PAHOR, M.; FIELDING, R.A.

2014-01-01

Objective To determine if sarcopenia modulates the response to a physical activity intervention in functionally limited older adults. Design Secondary analysis of a randomized controlled trial. Setting Three academic centers. Participants Elders aged 70 to 89 years at risk for mobility disability who underwent dual-energy x-ray absorptiometry (DXA) for body composition at enrollment and follow-up at twelve months (N = 177). Intervention Subjects participated in a physical activity program (PA) featuring aerobic, strength, balance, and flexibility training, or a successful aging (SA) educational program about healthy aging. Measurements Sarcopenia as determined by measuring appendicular lean mass and adjusting for height and total body fat mass (residuals method), Short Physical Performance Battery score (SPPB), and gait speed determined on 400 meter course. Results At twelve months, sarcopenic and non-sarcopenic subjects in PA tended to have higher mean SPPB scores (8.7±0.5 and 8.7±0.2 points) compared to sarcopenic and non-sarcopenic subjects in SA (8.3±0.5 and 8.4±0.2 points, p = 0.24 and 0.10), although the differences were not statistically significant. At twelve months, faster mean gait speeds were observed in PA: 0.93±0.4 and 0.95±0.03 meters/second in sarcopenic and non-sarcopenic PA subjects, and 0.89±0.4 and 0.91±0.03 meters/second in sarcopenic and non-sarcopenic SA subjects (p = 0.98 and 0.26), although not statistically significant. There was no difference between the sarcopenic and non-sarcopenic groups in intervention adherence or number of adverse events. Conclusion These data suggest that older adults with sarcopenia, who represent a vulnerable segment of the elder population, are capable of improvements in physical performance after a physical activity intervention. PMID:24402391

Identifying county characteristics associated with resident well-being: A population based study.

PubMed

Roy, Brita; Riley, Carley; Herrin, Jeph; Spatz, Erica S; Arora, Anita; Kell, Kenneth P; Welsh, John; Rula, Elizabeth Y; Krumholz, Harlan M

2018-01-01

Well-being is a positively-framed, holistic assessment of health and quality of life that is associated with longevity and better health outcomes. We aimed to identify county attributes that are independently associated with a comprehensive, multi-dimensional assessment of individual well-being. We performed a cross-sectional study examining associations between 77 pre-specified county attributes and a multi-dimensional assessment of individual US residents' well-being, captured by the Gallup-Sharecare Well-Being Index. Our cohort included 338,846 survey participants, randomly sampled from 3,118 US counties or county equivalents. We identified twelve county-level factors that were independently associated with individual well-being scores. Together, these twelve factors explained 91% of the variance in individual well-being scores, and they represent four conceptually distinct categories: demographic (% black); social and economic (child poverty, education level [

Executing effective road safety advertising: are big production budgets necessary?

PubMed

Donovan, R J; Jalleh, G; Henley, N

1999-05-01

Twelve (12) road safety television commercials (TVCs) ranging in production costs from $A15,000 to $A250,000 (current prices) were evaluated using standard advertising pre-test procedures. The twelve ads covered four road safety behaviours (speeding; drink driving; fatigue; and inattention), and included a variety of executional types within and across behaviours. One ad in each of the four behaviours was an expensive TAC and ($A200,000 or more). The testing procedure assessed respondents' self-reported impact of the ad on their future intentions to comply with the road safety behavior advocated in the ad. Just under 1000 appropriately screened motor vehicle drivers license holders were recruited via street intercept methods and randomly allocated to one of the twelve and exposure conditions. The results showed that while the two best performing ads were highly dramatic TAC ads showing graphic crash scenes, these were also the most expensive ads to produce, and, being 60 and 90 s, the most expensive to air. In several cases, 30 s low cost talking heads testimonials performed equally as well as their far more expensive counterparts. We conclude that big production budgets may not be necessary to create effective road safety advertising.

Empowerment of personal injury victims through the internet: design of a randomized controlled trial

PubMed Central

2011-01-01

Background Research has shown that current claims settlement process can have a negative impact on psychological and physical recovery of personal injury (PI) victims. One of the explanations for the negative impact on health is that the claims settlement process is a stressful experience and victims suffer from renewed victimization caused by the claims settlement process. PI victims can experience a lack of information, lack of involvement, lack of 'voice', and poor communication. We present the first study that aims to empower PI victims with respect to the negative impact of the claims settlement process by means of an internet intervention. Methods/design The study is a two armed, randomized controlled trial (RCT), in which 170 PI victims are randomized to either the intervention or control group. The intervention group will get access to a website providing 1) an information module, so participants learn what is happening and what to expect during the claims settlement process, and 2) an e-coach module, so participants learn to cope with problems they experience during the claims settlement process. The control group will get access to a website with hyperlinks to commonly available information only. Participants will be recruited via a PI claims settlement office. Participants are included if they have been involved in a traffic accident which happened less than two years ago, and are at least 18 years old. The main study parameter is the increase of empowerment within the intervention group compared to the control group. Empowerment will be measured by the mastery scale and a self-efficacy scale. The secondary outcomes are perceived justice, burden, well being, work ability, knowledge, amount of damages, and lawyer-client communication. Data are collected at baseline (T0 measurement before randomization), at three months, six months, and twelve months after baseline. Analyses will be conducted according to the intention-to-treat principle. Discussion This study evaluates the effectiveness of an internet intervention aimed at empowerment of PI victims. The results will give more insight into the impact of compensation proceedings on health over time, and they can have important consequences for legal claims settlement. Strengths and limitations of this study are discussed. Trial registration Netherlands Trial Register NTR2360 PMID:21288346

Does low-energy sweetener consumption affect energy intake and body weight? A systematic review, including meta-analyses, of the evidence from human and animal studies

PubMed Central

Rogers, P J; Hogenkamp, P S; de Graaf, C; Higgs, S; Lluch, A; Ness, A R; Penfold, C; Perry, R; Putz, P; Yeomans, M R; Mela, D J

2016-01-01

By reducing energy density, low-energy sweeteners (LES) might be expected to reduce energy intake (EI) and body weight (BW). To assess the totality of the evidence testing the null hypothesis that LES exposure (versus sugars or unsweetened alternatives) has no effect on EI or BW, we conducted a systematic review of relevant studies in animals and humans consuming LES with ad libitum access to food energy. In 62 of 90 animal studies exposure to LES did not affect or decreased BW. Of 28 reporting increased BW, 19 compared LES with glucose exposure using a specific ‘learning' paradigm. Twelve prospective cohort studies in humans reported inconsistent associations between LES use and body mass index (−0.002 kg m−2 per year, 95% confidence interval (CI) −0.009 to 0.005). Meta-analysis of short-term randomized controlled trials (129 comparisons) showed reduced total EI for LES versus sugar-sweetened food or beverage consumption before an ad libitum meal (−94 kcal, 95% CI −122 to −66), with no difference versus water (−2 kcal, 95% CI −30 to 26). This was consistent with EI results from sustained intervention randomized controlled trials (10 comparisons). Meta-analysis of sustained intervention randomized controlled trials (4 weeks to 40 months) showed that consumption of LES versus sugar led to relatively reduced BW (nine comparisons; −1.35 kg, 95% CI –2.28 to −0.42), and a similar relative reduction in BW versus water (three comparisons; −1.24 kg, 95% CI –2.22 to −0.26). Most animal studies did not mimic LES consumption by humans, and reverse causation may influence the results of prospective cohort studies. The preponderance of evidence from all human randomized controlled trials indicates that LES do not increase EI or BW, whether compared with caloric or non-caloric (for example, water) control conditions. Overall, the balance of evidence indicates that use of LES in place of sugar, in children and adults, leads to reduced EI and BW, and possibly also when compared with water. PMID:26365102

Dispensing good sleep health behaviours not pills--a cluster-randomized controlled trial to test the feasibility and efficacy of pharmacist-provided brief behavioural treatment for insomnia.

PubMed

Fuller, Joanne M; Wong, Keith K; Hoyos, Camilla; Krass, Ines; Saini, Bandana

2016-02-01

Behavioural therapies are recommended as the first-line treatment of insomnia; however, sedatives and hypnotics constitute the main treatment modality used in primary care. Community pharmacies provide a unique conduit for identifying and providing appropriate treatment for those with insomnia either purchasing prescription sedatives or seeking over-the-counter treatments. A feasibility study using a cluster-randomized controlled trial, testing the efficacy of trained pharmacists providing behavioural interventions such as stimulus control and sleep restriction to patients with insomnia, in improving insomnia severity was conducted. The intervention involved three pharmacy visits (baseline, 1 and 3 months follow-up). The control group received usual care and information sheets on insomnia. The primary outcome was the Insomnia Severity Index. Twelve community pharmacists (five control, seven intervention) in New South Wales, Australia were recruited and trained. These pharmacists, in turn, recruited 46 patients (22 control, 24 intervention (mean age 53.7 ± 18.4, 72% females) and delivered a brief behavioural therapy intervention. The overall decrease in Insomnia Severity Index from baseline to the 3-month follow-up in the intervention group, n = 17 (7.6 ± 4.3 points), was significantly greater than for the control group, n = 19 (2.9 ± 8.8 points) (mean difference 4.6, 95% confidence interval: 0.005-9.2, P = 0.05). However, when the effect of clustering was taken into account using a mixed-effects model, the estimated difference in Insomnia Severity Index (change from baseline to visit 3) between the intervention and control groups was not significant (group difference in Insomnia Severity Index change = 3.78, 95% confidence interval: -0.81 to 8.37, P = 0.11; intracluster correlation = 0.18). The study highlights the use of a novel venue to deliver brief behavioural therapies for insomnia using trained non-psychologist health professionals. Although, when cluster effect was taken into account, the difference in Insomnia Severity Index reduction between the intervention versus control groups was non-significant, the results highlight that reductions in insomnia severity can be gained using trained pharmacists providing brief behavioural interventions. Future research in this area is warranted, with appropriately sized studies using the conventional, robust randomized trial design. © 2015 The Authors. Journal of Sleep Research published by John Wiley & Sons Ltd on behalf of European Sleep Research Society.

Effects of sculpture based art therapy in dementia patients-A pilot study.

PubMed

Seifert, Kathrin; Spottke, Annika; Fliessbach, Klaus

2017-11-01

Art and art therapy open up interesting possibilities for dementia patients. However, it has not been evaluated scientifically so far, whether the art of sculpting has any benefits. In this non-randomized pilot study with twelve participants, we investigated the feasibility and acceptance of sculptural activity in patients with dementia and the effects on their well-being. A questionnaire was custom-designed to investigate five key aspects of well-being: mental state and concentration, corporeal memory, self-reliance, self-esteem and physicality. Remarkable improvements were seen in several subscales in the sculptural activity group, but not the control group: Mental state and concentration (nine of thirteen key aspects), self-reliance (four of five), self-esteem (one of one) and physicality (two of two). The results of this pilot study indicate the multidimensional effects of sculptural activity on patients living with dementia. The field would benefit greatly from further research.

Pairing attachment theory and social learning theory in video-feedback intervention to promote positive parenting.

PubMed

Juffer, Femmie; Bakermans-Kranenburg, Marian J; van IJzendoorn, Marinus H

2017-06-01

Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD) is a social-learning and attachment-based intervention using video feedback to support sensitive parenting and at the same time setting firm limits. Empirical studies and meta-analyses have shown that sensitive parenting is the key determinant to promote secure child-parent attachment relationships and that adequate parental discipline contributes to fewer behavior problems in children. Building on this evidence, VIPP-SD has been tested in various populations of at-risk parents and vulnerable children (in the age range of zero to six years), as well as in the context of child care. In twelve randomized controlled trials including 1116 parents and caregivers, VIPP-SD proved to be effective in promoting sensitive caregiving, while positive social-emotional child outcomes were also found. Copyright © 2017 Elsevier Ltd. All rights reserved.

Exploring experiences, barriers, and enablers to home- and class-based exercise in rotator cuff tendinopathy: A qualitative study.

PubMed

Sandford, Fiona M; Sanders, Thomas A B; Lewis, Jeremy S

Qualitative study. Adherence is paramount to the successful outcome of exercise-based treatment. The barriers and enablers to adherence to a home- and class-based exercise program were explored in this qualitative study. Semi-structured interviews were carried out to establish common themes relating to the participants' experiences during a year-long randomized controlled trial. Twelve participants were interviewed. The main enablers to exercise were highlighted as equipment, perceived benefit from the exercises, and longer and more intensive monitoring. Barriers included the lack of motivation, lack of equipment, and pain. Implications for practice are incorporating enablers and addressing barriers including self-discharge from classes; the importance of longer term follow-up and the benefits of adopting exercise into a well-established routine may provide potential benefits. N/A. Copyright © 2017 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

Memantine in the Treatment of Executive Function Deficits in Adults With ADHD.

PubMed

Biederman, Joseph; Fried, Ronna; Tarko, Laura; Surman, Craig; Spencer, Thomas; Pope, Amanda; Grossman, Rebecca; McDermott, Katie; Woodworth, K Yvonne; Faraone, Stephen V

2017-02-01

To evaluate the efficacy and safety of memantine hydrochloride as an adjunct to stimulant pharmacotherapy for treating executive function deficits (EFDs) in adults with ADHD. This was a 12-week, double-blind, placebo-controlled, randomized clinical trial of memantine added to open-label treatment with stimulant medication. Because of the small sample size, we considered a standardized mean difference (equivalent to effect size) of ≥0.5 and odds ratios ≥2 as indicators of trend improvements. Twelve participants received memantine and 14 received a placebo. Trend improvements favoring memantine were observed on Behavior Rating Inventory of Executive Functions-Adult Inhibition and Self-Monitor subscales when compared with Placebo. No significant changes were noted on the Cambridge Neuropsychological Test Automated Battery. Among adults with ADHD and EFDs, adjunct treatment with memantine to osmotic release oral system-methylphenidate (OROS-MPH) was associated with improvements in selective areas of executive functioning, supporting the need for further research.

Short structured general mental health in service training programme in Kenya improves patient health and social outcomes but not detection of mental health problems - a pragmatic cluster randomised controlled trial

PubMed Central

2013-01-01

Trial design A pragmatic cluster randomised controlled trial. Methods Participants: Clusters were primary health care clinics on the Ministry of Health list. Clients were eligible if they were aged 18 and over. Interventions: Two members of staff from each intervention clinic received the training programme. Clients in both intervention and control clinics subsequently received normal routine care from their health workers. Objective: To examine the impact of a mental health inservice training on routine detection of mental disorder in the clinics and on client outcomes. Outcomes: The primary outcome was the rate of accurate routine clinic detection of mental disorder and the secondary outcome was client recovery over a twelve week follow up period. Randomisation: clinics were randomised to intervention and control groups using a table of random numbers. Blinding: researchers and clients were blind to group assignment. Results Numbers randomised: 49 and 50 clinics were assigned to intervention and control groups respectively. 12 GHQ positive clients per clinic were identified for follow up. Numbers analysed: 468 and 478 clients were followed up for three months in intervention and control groups respectively. Outcome: At twelve weeks after training of the intervention group, the rate of accurate routine clinic detection of mental disorder was greater than 0 in 5% versus 0% of the intervention and control groups respectively, in both the intention to treat analysis (p = 0.50) and the per protocol analysis (p =0.50). Standardised effect sizes for client improvement were 0.34 (95% CI = (0.01,0.68)) for the General Health Questionnaire, 0.39 ((95% CI = (0.22, 0.61)) for the EQ and 0.49 (95% CI = (0.11,0.87)) for WHODAS (using ITT analysis); and 0.43 (95% CI = (0.09,0.76)) for the GHQ, 0.44 (95% CI = (0.22,0.65)) for the EQ and 0.58 (95% CI = (0.18,0.97)) for WHODAS (using per protocol analysis). Harms: None identified. Conclusion The training programme did not result in significantly improved recorded diagnostic rates of mental disorders in the routine clinic consultation register, but did have significant effects on patient outcomes in routine clinical practice. Trial registration International Standard Randomised Controlled Trial Number Register ISRCTN53515024. PMID:24188964

Clinical Effectiveness of Integrating Depression Care Management into Medicare Home Health: The Depression CAREPATH Cluster-Randomized Trial

PubMed Central

Bruce, Martha L.; Raue, Patrick J.; Reilly, Catherine F.; Greenberg, Rebecca L.; Meyers, Barnett S.; Banerjee, Samprit; Pickett, Yolonda R.; Sheeran, Thomas F.; Ghesquiere, Angela; Zukowski, Diane; Rosas, Vianca H.; McLaughlin, Jeanne; Pledger, Lori; Doyle, Joan; Joachim, Pamela; Leon, Andrew C.

2015-01-01

Importance Depression is highly prevalent, inadequately treated, and contributes to hospitalization and other poor outcomes in older home healthcare patients. Feasible and effective interventions are needed to reduce this burden of depression. Objective To determine whether among older Medicare home health recipients who screen positive for depression, patients of nurses randomized to intervention have greater improvement in depressive symptoms over one year compared to patients receiving enhanced usual care. Design The cluster-randomized effectiveness trial randomized nurse-teams to Intervention (12 teams) or enhanced usual care (9 teams). Patients were recruited 2009–2012, assessed, and followed at 3, 6, and 12-months by research staff blind to intervention status. Setting Conducted at six home healthcare agencies nationwide. Patients interviewed at home and by telephone. Participants Medicare home health patients age ≥65 who screened positive for depression on routine nurse assessments. Of 502 eligible patients, 306 enrolled. Intervention Depression CAREPATH (CARE for PATients at Home) requires nurses to manage depression during routine home visits by weekly symptom assessment, medication management, care coordination, education, goal setting. Training totaled 7 hours (4 on-site, 3 web). Researchers telephoned supervisors every other week. Main Outcome and Measure Depression severity, assessed by 24-item Hamilton Depression Rating Scale (HDRS). Results 306 participants were predominately female (69.6%), diverse (18.0% Black, 16.0% Hispanic), average age 76.5 (SD=8.0) years. In full sample, the intervention had no effect (treatment × time interaction: P=0.13). Adjusted HDRS scores (CAREPATH vs control) did not differ at three (10.5 vs 11.4; P=0.26) or six months (9.3 vs 10.5; P=0.12), barely reaching significance at twelve months (8.7 vs 10.6; P=0.05). In subsample with mild depression (HDRS<10), the intervention had no effect (P=.90) and HDRS did not differ at any follow-up. Among 208 participants with HDRS≥10, CAREPATH demonstrated effectiveness (P=0.02) with lower HDRS at three (14.1 vs 16.1; P=0.04), six (12.0 vs 14.7; P=0.02) and twelve months (11.8 vs 15.7; P=0.005). Exploratory analyses found no differences in number or length of home visits. Conclusion and Relevance Home health nurses can effectively integrate depression care management into routine practice. However, clinical benefit appears limited to only patients with moderate to severe depression. Trial Registration Clinicaltrials.gov Identifier: NCT01979302 http://clinicaltrials.gov/ct2/show/NCT01979302 PMID:25384017

Follow-up home visits with registered dietitians have a positive effect on the functional and nutritional status of geriatric medical patients after discharge: a randomized controlled trial.

PubMed

Beck, Anne Marie; Kjær, Stine; Hansen, Birthe Stenbæk; Storm, Rikke Lunau; Thal-Jantzen, Kirsten; Bitz, Christian

2013-06-01

To assess the additional benefits of individualized nutritional counselling by a registered dietitian in geriatric patients' home after discharge from hospital, in relation to risk of re-admissions, functional status, nutritional status, use of social services and mortality. Twelve-week single-blind randomized controlled study. Geriatric medical patients (65+ years) at nutritional risk. Participants were randomly allocated to receive a visit in their homes, either three individualized nutritional counselling by a registered dietitian complemented with three follow-up visits by general practitioners or three follow-up visits by general practitioners alone. Primary outcome was risk of re-admissions. Secondary outcomes were functional status (hand grip strength, chair stand, mobility, disability and tiredness in daily activities, rehabilitation capacity), nutritional status (weight, BMI, energy and protein intake), need of social services (home care, home nursing, meals-on-wheels) and mortality. One hundred and fifty-two patients were included; 132 (87%) completed the first and 124 (82%) the second data collection after 12 weeks. Ten per cent of the participants had three contacts with their general practitioner, while compliance with the dietetic intervention was almost 100%. Odds ratio for re-admission and mortality after 26 weeks was 1.62 (95% confidence interval (CI) 0.85 to 3.10) and 0.60 (95% CI 0.17 to 2.13). The intervention had a positive effect on functional status (i.e. mobility, P = 0.029), and nutritional status (i.e. weight, P = 0.035; energy intake, P < 0.001; protein intake, P = 0.001) and the use of meals-on wheels was reduced (P = 0.084). Follow-up home visits with registered dietitians have a positive effect on the functional and nutritional status of geriatric medical patients after discharge.

Impact of the CONSORT Statement endorsement in the completeness of reporting of randomized clinical trials in restorative dentistry.

PubMed

Sarkis-Onofre, Rafael; Poletto-Neto, Victório; Cenci, Maximiliano Sérgio; Pereira-Cenci, Tatiana; Moher, David

2017-03-01

The aim of this study was to assess if journal endorsement of the CONSORT Statement is associated with improved completeness of reporting of randomized controlled trials (RCTs) in restorative dentistry. RCTs in restorative dentistry published in two journals that have (Journal of Dentistry and Clinical Oral Investigations) and have not (Operative Dentistry and Journal of Prosthetic Dentistry) endorsed the CONSORT Statement were selected. We compared the completeness of reporting between comparison groups (endorsers versus non-endorsers, before versus after endorsement) using a risk ratio (RR) with a 99% confidence interval for each outcome of CONSORT 2010. Also, the risk of bias of each study was evaluated. The electronic search retrieved a total of 3701 records. After the title and abstract evaluation, 169 full texts were screened and 79 RCTs identified. Considering CONSORT-endorsing journals before and after CONSORT endorsement, six items had effect estimates indicating a relatively higher proportion of completely reported RCTs published after CONSORT endorsement. Considering CONSORT-endorsing journals compared to non-endorsing journals, twelve items indicated a relatively higher proportion of completely reported RCTs published in CONSORT-endorsing journals. In both analyses the overall evidence did not present statistical significance. Although CONSORT endorsement has been linked with some improvement in the completeness of RCTs reports in the biomedical literature, this was not reflected in the present analysis confined to restorative dentistry. More innovative and involved approaches to enhancing reported may therefore be required. Inadequate reporting of randomized controlled trials can produce important consequences for all stakeholders including waste of resources and implication on healthcare decisions. A broad understandment of the use of reporting guidelines is necessary to lead to better results. Copyright © 2017 Elsevier Ltd. All rights reserved.

Cluster-randomized trial on complementary and responsive feeding education to caregivers found improved dietary intake, growth, and development among rural Indian toddlers

PubMed Central

Vazir, Shahnaz; Engle, Patrice; Balakrishna, Nagalla; Griffiths, Paula L.; Johnson, Susan L.; Creed-Kanashiro, Hilary; Rao, Sylvia Fernandez; Shroff, Monal R.; Bentley, Margaret E.

2012-01-01

Inadequate feeding and care may contribute to high rates of stunting and underweight among children in rural families in India. This cluster-randomized trial tested the hypothesis that teaching caregivers appropriate complementary feeding, and strategies for how to feed and play responsively through home-visits would increase children’s dietary intake, growth, and development compared to home-visit-complementary feeding education alone or routine care. Sixty villages in Andhra Pradesh were randomized into 3 groups1 of 20 villages with 200 mother-infant dyads in each group. The Control Group (CG), received routine Integrated Child Development Services (ICDS); the Complementary Feeding Group (CFG), received the ICDS plus the World Health Organization recommendations on breastfeeding and complementary foods; and the Responsive Complementary Feeding & Play Group (RCF&PG) received the same intervention as the CFG plus skills for responsive feeding and psychosocial stimulation. Both intervention groups received bi-weekly visits by trained village women. The groups did not differ at 3 months on socioeconomic status, maternal and child nutritional indices and maternal depression. After controlling for potential confounding factors using the mixed models approach, the twelve-month intervention to the CFG and RCF&PG significantly (p<0.05) increased median intakes of energy, protein, Vitamin-A, calcium (CFG), iron and zinc, reduced stunting (0.19, CI: 0.0–0.4) in the CFG (but not RCF&PG) and increased (p<0.01) Bayley Mental Development scores(Mean=3.1, CI: 0.8–5.3) in the RCF&PG (but not CFG) compared to CG. Community-based educational interventions can improve dietary intake, length (CFG), and mental development (RCF&PG) for children under two years in food-secure rural Indian families. PMID:22625182

A matched-pair analysis comparing whole-brain radiotherapy with and without a stereotactic boost for intracerebral control and overall survival in patients with one to three cerebral metastases.

PubMed

Rades, Dirk; Janssen, Stefan; Bajrovic, Amira; Khoa, Mai Trong; Veninga, Theo; Schild, Steven E

2017-04-24

Twelve years ago, a randomized trial demonstrated that a radiosurgery boost added to whole-brain radiotherapy (WBRT) improved intracerebral control (IC) in patients with one to three cerebral metastases. Overall survival (OS) was improved only in the subgroup of patients with a single metastasis but not in the entire cohort. The present study compared both regimens in a different scenario outside a randomized trial. A total of 252 patients with one to three cerebral metastases were included. Eighty-four patients receiving WBRT plus a planned stereotactic boost and 168 patients receiving WBRT alone were individually matched 1:2 for nine factors including fractionation of WBRT, age, gender, performance score, primary tumor, number of cerebral metastases, extracerebral metastases, recursive partitioning analysis class, and time between cancer diagnosis and WBRT. Each group of three patients was required to match for all nine factors. Both groups were compared for IC and OS. IC rates at 6, 12, 18 and 24 months were 88, 71, 45 and 22% after WBRT plus stereotactic boost vs. 75, 48, 38 and 22% after WBRT alone (p = 0.005). OS rates at 6, 12, 18 and 24 months were 76, 53, 32 and 25% after WBRT plus stereotactic boost and 67, 45, 29 and 20% after WBRT alone (p = 0.10). In patients with a single lesion, OS rates were also not significantly different (p = 0.12). Similar to the previous randomized trial from 2004, this matched-pair study showed that a stereotactic boost in addition to WBRT significantly improved IC but not OS.

A web-based personalized risk communication and decision-making tool for women with dense breasts: Design and methods of a randomized controlled trial within an integrated health care system.

PubMed

Knerr, Sarah; Wernli, Karen J; Leppig, Kathleen; Ehrlich, Kelly; Graham, Amanda L; Farrell, David; Evans, Chalanda; Luta, George; Schwartz, Marc D; O'Neill, Suzanne C

2017-05-01

Mammographic breast density is one of the strongest risk factors for breast cancer after age and family history. Mandatory breast density disclosure policies are increasing nationally without clear guidance on how to communicate density status to women. Coupling density disclosure with personalized risk counseling and decision support through a web-based tool may be an effective way to allow women to make informed, values-consistent risk management decisions without increasing distress. This paper describes the design and methods of Engaged, a prospective, randomized controlled trial examining the effect of online personalized risk counseling and decision support on risk management decisions in women with dense breasts and increased breast cancer risk. The trial is embedded in a large integrated health care system in the Pacific Northwest. A total of 1250 female health plan members aged 40-69 with a recent negative screening mammogram who are at increased risk for interval cancer based on their 5-year breast cancer risk and BI-RADS® breast density will be randomly assigned to access either a personalized web-based counseling and decision support tool or standard educational content. Primary outcomes will be assessed using electronic health record data (i.e., chemoprevention and breast MRI utilization) and telephone surveys (i.e., distress) at baseline, six weeks, and twelve months. Engaged will provide evidence about whether a web-based personalized risk counseling and decision support tool is an effective method for communicating with women about breast density and risk management. An effective intervention could be disseminated with minimal clinical burden to align with density disclosure mandates. Clinical Trials Registration Number:NCT03029286. Copyright © 2017 Elsevier Inc. All rights reserved.

[Effects of Gukang on bone-source alkaline phosphatase (BALP) and insulin-like growth factor-1 (IGF-1) in serum of spaying rats].

PubMed

Chen, Yi-fan; Huang, Hong-xing; Li, Ying

2009-02-01

To investigate the effects of Gukang on bone-source alkaline phosphatase (BALP) and insulin-like growth factor 1 (IGF-1) in serum of spaying rats and the mechanism of curative effect of Gukang on osteoporosis. Sixty-eight 6-month-old SD rats were chosen and randomly divided into blank control group (22 rats with sham operation) and operation group (46 rats with spaying operation). Three months after operation, 10 rats were randomly chosen from each group and tested with bone mineral density in order to determine models of osteoporosis made. After modeling, operation group was divided into 3 sub-groups: operation model group, estrogen group and Gukang group, 12 rars in each group. Twelve rats remained in blank control group. Every group were treated through intragastric administration therapy (volume 10 ml/kg). Blank control group and operation model group were irrigated with distilled water,estrogen group with estrogen and Gukang group with Gukang. Three months after treatment, serum of all groups were collected and tested for E2, BALP and IGF-1 with ELISA. The concentration of serum E2, BALP in estrogen group and Gukang group were higher than operation model group, there were significant difference (P < 0.05), but no significant difference in serum E2 between estrogen group and Gukang group (P > 0.05). The concentration of serum IGF-1 in Gukang group was higher than operation model group and blank control group, there were significant difference (P < 0.05). Gukang can increase the level of E2, BALP and IGF-1 in serum of spaying rats. Thus, it can indirectly promote reproduction of osteoblasts, inhibit activity of osteoclasts and promote bone formation.

Systematic review of interventions for children with Fetal Alcohol Spectrum Disorders

PubMed Central

Peadon, Elizabeth; Rhys-Jones, Biarta; Bower, Carol; Elliott, Elizabeth J

2009-01-01

Background Children with Fetal Alcohol Spectrum Disorders (FASD) may have significant neurobehavioural problems persisting into adulthood. Early diagnosis may decrease the risk of adverse life outcomes. However, little is known about effective interventions for children with FASD. Our aim is to conduct a systematic review of the literature to identify and evaluate the evidence for pharmacological and non-pharmacological interventions for children with FASD. Methods We did an electronic search of the Cochrane Library, MEDLINE, EMBASE, PsychINFO, CINAHL and ERIC for clinical studies (Randomized controlled trials (RCT), quasi RCT, controlled trials and pre- and post-intervention studies) which evaluated pharmacological, behavioural, speech therapy, occupational therapy, physiotherapy, psychosocial and educational interventions and early intervention programs. Participants were aged under 18 years with a diagnosis of a FASD. Selection of studies for inclusion and assessment of study quality was undertaken independently by two reviewers. Meta-analysis was not possible due to diversity in the interventions and outcome measures. Results Twelve studies met the inclusion criteria. Methodological weaknesses were common, including small sample sizes; inadequate study design and short term follow up. Pharmacological interventions, evaluated in two studies (both RCT) showed some benefit from stimulant medications. Educational and learning strategies (three RCT) were evaluated in seven studies. There was some evidence to suggest that virtual reality training, cognitive control therapy, language and literacy therapy, mathematics intervention and rehearsal training for memory may be beneficial strategies. Three studies evaluating social communication and behavioural strategies (two RCT) suggested that social skills training may improve social skills and behaviour at home and Attention Process Training may improve attention. Conclusion There is limited good quality evidence for specific interventions for managing FASD, however seven randomized controlled trials that address specific functional deficits of children with FASD are underway or recently completed. PMID:19463198

Effects of life review on mental health and well-being among cancer patients: A systematic review.

PubMed

Zhang, Xiaoling; Xiao, Huimin; Chen, Ying

2017-09-01

Cancer patients often experience psychological distress. Life review has increasingly been used to enhance their mental health and well-being. However, no systematic review has synthesized the evidence, and its effects remain unclear. To examine and synthesize the best available evidence on the effects of life review on mental health and well-being among cancer patients. Systematic review of randomized controlled trials and clinical controlled trials. Twelve electronic databases were searched for published studies reported in English or Chinese, from inception to September 2016. Other supplementary sources, such as related websites, professional books, reference lists, and author contacts were also used for published or unpublished studies. A comprehensive literature search was conducted to identify eligible randomized controlled trials or clinical controlled trials about the effects of life review on cancer patients. Study selection, quality assessment, and data extraction were independently performed by two reviewers. The results were synthesized without meta-analysis in this review. Fifteen studies (899 participants) were identified; of that total, nine studies were rated as strong in quality, while six studies were of moderate quality. In addition to structured life review interviews, other elements such as memory prompts and a legacy product were integrated into life review programs. A majority of studies indicated that life review programs benefited cancer patients by reducing depression and anxiety, as well as improving their sense of hope, self-esteem and quality of life. Life review can improve mental health and well-being among cancer patients. This suggests that life review can be integrated into typical cancer treatment to enhance patients' mental health and well-being. More research with rigorous design is necessary to further explore the effects of life review. Copyright © 2017 Elsevier Ltd. All rights reserved.

Continuous theta-burst stimulation may improve visuospatial neglect via modulating the attention network: a randomized controlled study.

PubMed

Fu, Wei; Cao, Lei; Zhang, Yanming; Huo, Su; Du, JuBao; Zhu, Lin; Song, Weiqun

2017-05-01

Visuospatial neglect (VSN) is devastating and common after stroke, and is thought to involve functional disturbance of the attention network. Non-invasive theta-burst stimulation (TBS) may help restore the normal function of attention network, therefore facilitating recovery from VSN. This study investigated the effects of continuous TBS on resting-state functional connectivity (RSFC) in the attention network, and behavioral performances of patients with VSN after stroke. Twelve patients were randomly assigned to receive 10-day cTBS of the left posterior parietal cortex delivered at 80% (the cTBS group), or 40% (the active control group) of the resting motor threshold. Both groups received daily visual scanning training and motor function treatment. Resting-state functional MRI (fMRI) and behavioral tests including line bisection test and star cancelation test were conducted at baseline and after the treatment. At baseline, the two groups showed comparable results in the resting-state fMRI experiments and behavioral tests. After treatment, the cTBS group showed lower functional connectivity between right temporoparietal junction (TPJ) and right anterior insula, and between right superior temporal sulcus and right anterior insula, as compared with the active control group; both groups showed improvement in the behavioral tests, with the cTBS group showing larger changes from baseline than the active control group. cTBS of the left posterior parietal cortex in patients with VSN may induce changes in inter-regional RSFC in the right ventral attention network. These changes may be associated with improved recovery of behavioral deficits after behavioral training. The TPJ and superior temporal sulcus may play crucial roles in recovery from VSN.

College students as facilitators in reducing adolescent obesity disparity in Southern Appalachia: Team Up for Healthy Living

PubMed Central

Dalton, William T.; Dula, Taylor McKeehan; Southerland, Jodi; Wang, Liang; Littleton, Mary Ann; Mozen, Diana; Relyea, George; Schetzina, Karen; Lowe, Elizabeth F.; Stoots, James M.; Wu, Tiejian

2015-01-01

The proportion of obese adolescents in Southern Appalachia is among the highest in the nation. Through funding from the National Institute on Minority Health and Health Disparities – National Institutes of Health, the Team Up for Healthy Living project was a cluster-randomized trial targeting obesity prevention in adolescents through a cross-peer intervention. The specific aims of the project were to: 1) develop a peer-based health education program focusing on establishing positive peer norms towards healthy eating and physical activity (PA) among high school students, 2) test program efficacy, and 3) explore mechanisms underlying the program. The study was guided by the Theory of Planned Behavior, which presupposes that human behavior is primarily driven by attitude, subjective norms, perceived behavioral control, and social support. To deliver the intervention, undergraduate students from the disciplines of public health, nutrition, and kinesiology were hired as peer facilitators. Ten area high schools were invited to participate, were matched on demographics and then randomized to intervention or control. The primary outcomes of the study included body mass status, dietary behaviors, PA, and sedentary behaviors which were assessed at baseline and at three and twelve months post baseline. Intervention schools received Team Up for Healthy Living curriculum, which consists of eight 40-minute sessions. The curriculum focused on improving nutrition awareness, PA, leadership and communication. Control schools received their regularly scheduled Lifetime Wellness curriculum. The long-term goal of the study was to establish an effective academia–community partnership program to address adolescent obesity disparity in Southern Appalachia. PMID:25937506

Reduction of erosive wear in situ by stannous fluoride-containing toothpaste.

PubMed

Huysmans, M C D N J M; Jager, D H J; Ruben, J L; Unk, D E M F; Klijn, C P A H; Vieira, A M

2011-01-01

Stannous fluoride (SnF) has been suggested as a dental erosion-preventive agent. The aim of this single-centre, randomized, double-blind, in situ study was to evaluate the effect of toothpastes with SnF in the prevention of erosive enamel wear. A combined split-mouth (extra-oral water or toothpaste brushing) and crossover (type of toothpaste) set-up was used. Twelve volunteers wore palatal appliances containing human enamel samples. Three toothpastes were used, in three consecutive runs, in randomized order: two toothpastes containing SnF (coded M and PE) and one toothpaste containing only sodium fluoride (coded C). On day 1 of each run the appliances were worn for pellicle formation. On days 2-5 the samples were also brushed twice with a toothpaste-water slurry or only water (control). Erosion took place on days 2-5 extra-orally 3 times a day (5 min) in a citric acid solution (pH 2.3). Enamel wear depth was quantified by optical profilometry. The effect of toothpastes was tested using General Linear Modeling. Average erosive wear depth of control samples was 23 μm. Both SnF toothpastes significantly reduced erosive wear: M by 34% (SD 39%) and PE by 26% (SD 25%). The control toothpaste reduced erosive wear non-significantly by 7% (SD 20%). Both SnF-containing toothpastes significantly reduced erosive wear compared to the sodium fluoride toothpaste. We conclude that SnF-containing toothpastes are able to reduce erosive tooth wear in situ. Copyright © 2011 S. Karger AG, Basel.

Effect of Weight Maintenance on Symptoms of Knee Osteoarthritis in Obese Patients: A Twelve-Month Randomized Controlled Trial

PubMed Central

Christensen, Robin; Henriksen, Marius; Leeds, Anthony R; Gudbergsen, Henrik; Christensen, Pia; Sørensen, Tina J; Bartels, Else M; Riecke, Birgit F; Aaboe, Jens; Frederiksen, Rikke; Boesen, Mikael; Lohmander, L Stefan; Astrup, Arne; Bliddal, Henning

2015-01-01

Objective To compare results of obese patients with knee osteoarthritis (OA) who, after an intensive weight loss regimen, received 1 year of either dietary support (D), a knee-exercise program (E), or “no attention” (C; control group). Methods We conducted a randomized, 2-phase, parallel-group trial. A total of 192 obese participants with knee OA were enrolled; the mean age was 62.5 years and 81% were women with a mean entry weight of 103.2 kg. In phase 1, all participants were randomly assigned to 1 of 3 groups and began a dietary regimen of 400–810 and 1,250 kcal/day for 16 weeks (2 8-week phases) to achieve a major weight loss. Phase 2 consisted of 52 weeks' maintenance in either group D, E, or C. Outcomes were changes from randomization in pain on a 100-mm visual analog scale, weight, and response according to the Outcome Measures in Rheumatology-Osteoarthritis Research Society International criteria. Results Mean weight loss for phase 1 was 12.8 kg. After 1 year on maintenance therapy, the D group sustained a lower weight (11.0 kg, 95% confidence interval [95% CI] 9.0, 12.8 kg) than those in the E (6.2, 95% CI 4.4, 8.1 kg) and C (8.2, 95% CI 6.4, 10.1 kg) groups (P = 0.002 by analysis of covariance [ANCOVA]). Adherence was low in the E group. All groups had statistically significant pain reduction (D: 6.1; E: 5.6; and C: 5.5 mm) with no difference between groups (P = 0.98 by ANCOVA). In each group 32 (50%), 26 (41%), and 33 (52%) participants responded to treatment in the D, E, and C groups, respectively, with no statistically significant difference in the number of responders (P = 0.41). Conclusion A significant weight reduction with a 1-year maintenance program improves knee OA symptoms irrespective of maintenance program. PMID:25370359

Body composition influenced by progressive elastic band resistance exercise of sarcopenic obesity elderly women: a pilot randomized controlled trial.

PubMed

Huang, Shih-Wei; Ku, Jan-Wen; Lin, Li-Fong; Liao, Chun-De; Chou, Lin-Chuan; Liou, Tsan-Hon

2017-08-01

Sarcopenia involves age-related decreases in muscle strength and muscle mass, leading to frailty and disability in elderly people. When combined with obesity, it is defined as sarcopenic obesity (SO), which can result in more functional limitations and metabolic disorders than either disorder alone. The aim of this study was to investigate body composition changes after elastic band resistance training in elderly women with SO. Randomized single-blinded (assessor blinded) controlled pilot trial. Academic medical center. Thirty-five elderly (>60 years old) women with SO. This pilot randomized controlled trial focused on elderly women with SO. The study group underwent progressive elastic band resistance training for 12 weeks (3 times per week). The control group received only a 40-minute lesson about the exercise concept. Dual-energy X-ray absorptiometry was performed before and after intervention to evaluate body composition. Mann-Whitney U and Wilcoxon signed rank tests were used to analyze the differences within and between these groups. In total, 35 elderly women with SO were enrolled and divided into study (N.=18) and control groups (N.=17). No difference was observed in age, biochemical parameters, or Body Mass Index between both groups. After the intervention, the fat proportion of body composition in the right upper extremity (P=0.03), left upper extremity (P=0.04), total fat (P=0.035), and fat percentage (P=0.012) had decreased, and bone mineral density (BMD) (P=0.026), T-score (P=0.028), and Z-score (P=0.021) had increased in the study group. Besides, statistical difference was observed in outcome measurements of right upper extremity (P=0.013), total fat (P=0.023), and fat percentage (P=0.012) between the groups. Our study demonstrated that progressive elastic band resistance exercise can reduce fat mass and increase BMD in elderly women with SO, and that this exercise program is feasible for this demographic. Additional studies with larger sample sizes and longer intervention periods should be conducted. Twelve weeks of progressive elastic band resistance exercise program is safe and effective for SO elder women.

The Study of HIV and Antenatal Care Integration in Pregnancy in Kenya: Design, Methods, and Baseline Results of a Cluster-Randomized Controlled Trial

PubMed Central

Turan, Janet M.; Steinfeld, Rachel L.; Onono, Maricianah; Bukusi, Elizabeth A.; Woods, Meghan; Shade, Starley B.; Washington, Sierra; Marima, Reson; Penner, Jeremy; Ackers, Marta L.; Mbori-Ngacha, Dorothy; Cohen, Craig R.

2012-01-01

Background Despite strong evidence for the effectiveness of anti-retroviral therapy for improving the health of women living with HIV and for the prevention of mother-to-child transmission (PMTCT), HIV persists as a major maternal and child health problem in sub-Saharan Africa. In most settings antenatal care (ANC) services and HIV treatment services are offered in separate clinics. Integrating these services may result in better uptake of services, reduction of the time to treatment initiation, better adherence, and reduction of stigma. Methodology/Principal Findings A prospective cluster randomized controlled trial design was used to evaluate the effects of integrating HIV treatment into ANC clinics at government health facilities in rural Kenya. Twelve facilities were randomized to provide either fully integrated services (ANC, PMTCT, and HIV treatment services all delivered in the ANC clinic) or non-integrated services (ANC clinics provided ANC and basic PMTCT services and referred clients to a separate HIV clinic for HIV treatment). During June 2009– March 2011, 1,172 HIV-positive pregnant women were enrolled in the study. The main study outcomes are rates of maternal enrollment in HIV care and treatment, infant HIV testing uptake, and HIV-free infant survival. Baseline results revealed that the intervention and control cohorts were similar with respect to socio-demographics, male partner HIV testing, sero-discordance of the couple, obstetric history, baseline CD4 count, and WHO Stage. Challenges faced while conducting this trial at low-resource rural health facilities included frequent staff turnover, stock-outs of essential supplies, transportation challenges, and changes in national guidelines. Conclusions/Significance This is the first randomized trial of ANC and HIV service integration to be conducted in rural Africa. It is expected that the study will provide critical evidence regarding the implementation and effectiveness of this service delivery strategy, with important implications for programs striving to eliminate vertical transmission of HIV and improve maternal health. Trial Registration ClinicalTrials.gov NCT00931216 NCT00931216. PMID:22970177

Evaluation of the Combined Application of Neuromuscular Electrical Stimulation and Volitional Contractions on Thigh Muscle Strength, Knee Pain and Physical Performance in Women at Risk for Knee Osteoarthritis: A Randomized Controlled Trial.

PubMed

Rabe, Kaitlin G; Matsuse, Hiroo; Jackson, Anthony; Segal, Neil A

2018-05-28

Knee osteoarthritis (OA) is a leading cause of disability that is associated with quadriceps weakness. However, strengthening in people with or with risk factors for knee OA can be poorly tolerated. To assess the efficacy of a twelve-week low-load exercise program, using a hybrid training system (HTS) that utilizes the combination of neuromuscular electrical stimulation and volitional contractions, for improving thigh muscle strength, knee pain and physical performance in women with or with risk factors for knee OA. Randomized, single-blind, controlled trial SETTING: Exercise training laboratory PARTICIPANTS: Forty-two women, age 44-85 years, with risk factors for knee OA INTERVENTIONS: Participants randomized to 12 weeks of biweekly low-load resistance training either with HTS or on an isokinetic dynamometer (control). Maximum isokinetic knee extensor torque. Secondary measures included: maximum isokinetic knee flexor torque, knee pain (KOOS), and timed 20-meter walk and chair-stand tests. HTS and control both resulted in muscle strengthening, reduced knee pain and improved physical performance. HTS group quadriceps and hamstring strength increased by 0.06±0.04 Nm/kg (p>.05) and 0.05±0.02 Nm/kg (p=.02), respectively. Control group quadriceps and hamstring strength increased by 0.03±0.04 Nm/kg (p>.05) and 0.06±0.02 Nm/kg (p=.009), respectively. Knee pain improved by 11.9±11.5 points (p<.001) for the HTS group and 14.1±15.4 points (p=.001) for the control group. 20-meter walk time decreased by 1.60±2.04 seconds (p=.005) and 0.95±1.2 seconds (p=.004), and chair stand time decreased by 4.8±10.0 seconds (p>.05) and 1.9±4.7 seconds (p>.05) in the HTS and control groups, respectively. These results did not differ statistically between HTS and control groups. These results suggest HTS is effective for improving pain and physical performance in women with risk factors for knee OA. However, HTS does not appear to be superior to low-load resistance training for improving muscle strength, pain or physical function. Copyright © 2018 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

The Relationship between Zinc Levels and Autism: A Systematic Review and Meta-analysis.

PubMed

Babaknejad, Nasim; Sayehmiri, Fatemeh; Sayehmiri, Kourosh; Mohamadkhani, Ashraf; Bahrami, Somaye

2016-01-01

Autism is a complex behaviorally defined disorder.There is a relationship between zinc (Zn) levels in autistic patients and development of pathogenesis, but the conclusion is not permanent. The present study conducted to estimate this probability using meta-analysis method. In this study, Fixed Effect Model, twelve articles published from 1978 to 2012 were selected by searching Google scholar, PubMed, ISI Web of Science, and Scopus and information were analyzed. I² statistics were calculated to examine heterogeneity. The information was analyzed using R and STATA Ver. 12.2. There was no significant statistical difference between hair, nail, and teeth Zn levels between controls and autistic patients: -0.471 [95% confidence interval (95% CI): -1.172 to 0.231]. There was significant statistical difference between plasma Zn concentration and autistic patients besides healthy controls: -0.253 (95% CI: 0.498 to -0.007). Using a Random Effect Model, the overall Integration of data from the two groups was -0.414 (95% CI: -0.878 to -0.051). Based on sensitivity analysis, zinc supplements can be used for the nutritional therapy for autistic patients.

Performance of crossbred calves with dietary supplementation of garlic extract.

PubMed

Ghosh, S; Mehla, R K; Sirohi, S K; Tomar, S K

2011-08-01

Twelve crossbred calves (Holstein cross) in their pre-ruminant stage were used to study the effect of garlic extract feeding on their performance and they were randomly allotted into treatment and control groups in equal number. Performance was evaluated by measuring average body weight (BW) gain, feed intake [dry matter (DM); total digestible nutrient (TDN) and crude protein (CP)], feed conversion efficiency (DM, TDN and CP), fecal score and fecal coliform count. Diets were same for both groups. In addition, treatment group received garlic extract supplementation at 250 mg/kg BW/day/calf. BW measured weekly, feed intake measured twice daily, proximate analysis of feeds and fodders analysed weekly, fecal scores monitored daily and fecal coliform count done weekly. There was a significant (p < 0.01) increase in mean BW gain and feed intake and a significant (p < 0.01) decrease in severity of scours as measured by fecal score in the treatment group compared to the control group. The results suggest that garlic extract can be supplemented to the calves for better performance. © 2010 Blackwell Verlag GmbH.

Mind-body interventions during pregnancy.

PubMed

Beddoe, Amy E; Lee, Kathryn A

2008-01-01

To examine published evidence on the effectiveness of mind-body interventions during pregnancy on perceived stress, mood, and perinatal outcomes. Computerized searches of PubMed, Cinahl, PsycINFO, and the Cochrane Library. Twelve out of 64 published intervention studies between 1980 and February 2007 of healthy, adult pregnant women met criteria for review. Studies were categorized by type of mind-body modality used. Progressive muscle relaxation was the most common intervention. Other studies used a multimodal psychoeducation approach or a yoga and meditation intervention. The research contained methodological problems, primarily absence of a randomized control group or failure to adequately control confounding variables. Nonetheless, there was modest evidence for the efficacy of mind-body modalities during pregnancy. Treatment group outcomes included higher birthweight, shorter length of labor, fewer instrument-assisted births, and reduced perceived stress and anxiety. There is evidence that pregnant women have health benefits from mind-body therapies used in conjunction with conventional prenatal care. Further research is necessary to build on these studies in order to predict characteristics of subgroups that might benefit from mind-body practices and examine cost effectiveness of these interventions on perinatal outcomes.

Controlling Tensegrity Robots through Evolution using Friction based Actuation

NASA Technical Reports Server (NTRS)

Kothapalli, Tejasvi; Agogino, Adrian K.

2017-01-01

Traditional robotic structures have limitations in planetary exploration as their rigid structural joints are prone to damage in new and rough terrains. In contrast, robots based on tensegrity structures, composed of rods and tensile cables, offer a highly robust, lightweight, and energy efficient solution over traditional robots. In addition tensegrity robots can be highly configurable by rearranging their topology of rods, cables and motors. However, these highly configurable tensegrity robots pose a significant challenge for locomotion due to their complexity. This study investigates a control pattern for successful locomotion in tensegrity robots through an evolutionary algorithm. A twelve-rod hardware model is rapidly prototyped to utilize a new actuation method based on friction. A web-based physics simulation is created to model the twelve-rod tensegrity ball structure. Square-waves are used as control policies for the actuators of the tensegrity structure. Monte Carlo trials are run to find the most successful number of amplitudes for the square-wave control policy. From the results, an evolutionary algorithm is implemented to find the most optimized solution for locomotion of the twelve-rod tensegrity structure. The software pattern coupled with the new friction based actuation method can serve as the basis for highly efficient tensegrity robots in space exploration.

The impact of grape seed extract treatment on blood pressure changes: A meta-analysis of 16 randomized controlled trials.

PubMed

Zhang, Haili; Liu, Shuang; Li, Lan; Liu, Shisong; Liu, Shuqi; Mi, Jia; Tian, Geng

2016-08-01

Several clinical trials have shown that grape seed extract can reduce blood pressure, but the results are often irreproducible. We therefore sought to systematically evaluate the impact of grape seed extract treatment on the changes of systolic/diastolic blood pressure (SBP/DBP) by meta-analyzing available randomized controlled trials. Trial selection and data extraction were completed independently by 2 investigators. Effect-size estimates were expressed as weighted mean difference (WMD) and 95% confidence interval (CI). Twelve articles involving 16 clinical trials and 810 study subjects were analyzed. Overall analyses found significant reductions for SBP (WMD = -6.077; 95% CI: -10.736 to -1.419; P = 0.011) and DBP (WMD = -2.803; 95% CI: -4.417 to -1.189; P = 0.001) after grape seed extract treatment. In subgroup analyses, there were significant reductions in younger subjects (mean age < 50 years) for SBP (WMD = -6.049; 95% CI: -10.223 to -1.875; P = 0.005) and DBP (WMD = -3.116; 95% CI: -4.773 to -1.459; P < 0.001), in obese subjects (mean body mass index ≥ 25 kg/m) for SBP (WMD = -4.469; 95% CI: -6.628 to -2.310; P < 0.001), and in patients with metabolic syndrome for SBP (WMD = -8.487; 95% CI: -11.869 to -5.106; P < 0.001). Further meta-regression analyses showed that age, body mass index, and baseline blood pressure were negatively associated with the significant reductions of SBP and DBP after treatment. There was no indication of publication bias. Our findings demonstrate that grape seed extract exerted a beneficial impact on blood pressure, and this impact was more obvious in younger or obese subjects, as well as in patients with metabolic disorders. In view of the small sample size involved, we agree that confirmation of our findings in a large-scale, long-term, multiple-dose randomized controlled trial, especially among hypertensive patients is warranted.

Nigral stimulation for resistant axial motor impairment in Parkinson’s disease? A randomized controlled trial

PubMed Central

Walach, Margarete; Meisner, Christoph; Fritz, Melanie; Scholten, Marlieke; Breit, Sorin; Plewnia, Christian; Bender, Benjamin; Gharabaghi, Alireza; Wächter, Tobias

2013-01-01

Gait and balance disturbances typically emerge in advanced Parkinson’s disease with generally limited response to dopaminergic medication and subthalamic nucleus deep brain stimulation. Therefore, advanced programming with interleaved pulses was put forward to introduce concomittant nigral stimulation on caudal contacts of a subthalamic lead. Here, we hypothesized that the combined stimulation of subthalamic nucleus and substantia nigra pars reticulata improves axial symptoms compared with standard subthalamic nucleus stimulation. Twelve patients were enrolled in this 2 × 2 cross-over double-blind randomized controlled clinical trial and both the safety and efficacy of combined subthalamic nucleus and substantia nigra pars reticulata stimulation were evaluated compared with standard subthalamic nucleus stimulation. The primary outcome measure was the change of a broad-scaled cumulative axial Unified Parkinson’s Disease Rating Scale score (Scale II items 13–15, Scale III items 27–31) at ‘3-week follow-up’. Secondary outcome measures specifically addressed freezing of gait, balance, quality of life, non-motor symptoms and neuropsychiatric symptoms. For the primary outcome measure no statistically significant improvement was observed for combined subthalamic nucleus and substantia nigra pars reticulata stimulation at the ‘3-week follow-up’. The secondary endpoints, however, revealed that the combined stimulation of subthalamic nucleus and substantia nigra pars reticulata might specifically improve freezing of gait, whereas balance impairment remained unchanged. The combined stimulation of subthalamic nucleus and substantia nigra pars reticulata was safe, and of note, no clinically relevant neuropsychiatric adverse effect was observed. Patients treated with subthalamic nucleus and substantia nigra pars reticulata stimulation revealed no ‘global’ effect on axial motor domains. However, this study opens the perspective that concomittant stimulation of the substantia nigra pars reticulata possibly improves otherwise resistant freezing of gait and, therefore, highly warrants a subsequent phase III randomized controlled trial. PMID:23757762

A Decision Aid to Promote Appropriate Colorectal Cancer Screening among Older Adults: A Randomized Controlled Trial.

PubMed

Lewis, Carmen L; Kistler, Christine E; Dalton, Alexandra F; Morris, Carolyn; Ferrari, Renée; Barclay, Colleen; Brewer, Noel T; Dolor, Rowena; Harris, Russell; Vu, Maihan; Golin, Carol E

2018-07-01

Concerns have been raised about both over- and underutilization of colorectal cancer (CRC) screening in older patients and the need to align screening behavior with likelihood of net benefit. The purpose of this study was to test a novel use of a patient decision aid (PtDA) to promote appropriate CRC screening in older adults. A total of 424 patients ages 70 to 84 y who were not up to date with CRC screening participated in a double-blinded randomized controlled trial of a PtDA targeted to older adults making decisions about whether to undergo CRC screening from March 2012 to February 2015. Patients were randomized to a targeted PtDA or an attention control. The PtDA was designed to facilitate individualized decision making-helping patients understand the potential risks, benefits, and uncertainties of CRC screening given advanced age, health state, preferences, and values. Two composite outcomes, appropriate CRC screening behavior 6 mo after the index visit and appropriate screening intent immediately after the visit, were defined as completed screening or intent for patients in good health, discussion about screening with their provider for patients in intermediate health, and no screening or intent for patients in poor health. Health state was determined by age and Charlson Comorbidity Index. Four hundred twelve (97%) and 421 (99%) patients were analyzed for the primary and secondary outcomes, respectively. Appropriate screening behavior at 6 mo was higher in the intervention group (55% v. 45%, P = 0.023) as was appropriate screening intent following the provider visit (61% v. 47%, P = 0.003). The study took place in a single geographic region. The appropriate CRC screening classification system used in this study has not been formally validated. A PtDA for older adults promoted appropriate CRC screening behavior and intent. Clinicaltrials.gov, registration number NCT01575990. https://clinicaltrials.gov/ct2/show/NCT01575990?term=epic-d&rank=1.

Efficacy of Different Types of Mobilization Techniques in Patients With Primary Adhesive Capsulitis of the Shoulder: A Systematic Review.

PubMed

Noten, Suzie; Meeus, Mira; Stassijns, Gaetane; Van Glabbeek, Francis; Verborgt, Olivier; Struyf, Filip

2016-05-01

To systematically review the literature for efficacy of isolated articular mobilization techniques in patients with primary adhesive capsulitis (AC) of the shoulder. PubMed and Web of Science were searched for relevant studies published before November 2014. Additional references were identified by manual screening of the reference lists. All English language randomized controlled trials evaluating the efficacy of mobilization techniques on range of motion (ROM) and pain in adult patients with primary AC of the shoulder were included in this systematic review. Twelve randomized controlled trials involving 810 patients were included. Two reviewers independently screened the articles, scored methodologic quality, and extracted data for analysis. The review was conducted and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. All studies were assessed in duplicate for risk of bias using the Physiotherapy Evidence Database Scale for randomized controlled trials. The efficacy of 7 different types of mobilization techniques was evaluated. Angular mobilization (n=2), Cyriax approach (n=1), and Maitland technique (n=6) showed improvement in pain score and ROM. With respect to translational mobilizations (n=1), posterior glides are preferred to restore external rotation. Spine mobilizations combined with glenohumeral stretching and both angular and translational mobilization (n=1) had a superior effect on active ROM compared with sham ultrasound. High-intensity mobilization (n=1) showed less improvement in the Constant Murley Score than a neglect group. Finally, positive long-term effects of the Mulligan technique (n=1) were found on both pain and ROM. Overall, mobilization techniques have beneficial effects in patients with primary AC of the shoulder. Because of preliminary evidence for many mobilization techniques, the Maitland technique and combined mobilizations seem recommended at the moment. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

PHASE 2 SAFETY AND TOLERABILITY STUDY OF MARAVIROC-CONTAINING REGIMENS TO PREVENT HIV INFECTION IN WOMEN (HPTN 069/ACTG A5305): A RANDOMIZED TRIAL

PubMed Central

Gulick, Roy M.; Wilkin, Timothy J.; Chen, Ying Q.; Landovitz, Raphael J.; Amico, K. Rivet; Young, Alicia M.; Richardson, Paul; Marzinke, Mark A.; Hendrix, Craig W.; Eshleman, Susan H.; McGowan, Ian; Cottle, Leslie M.; Andrade, Adriana; Marcus, Cheryl; Klingman, Karin L.; Chege, Wairimu; Rinehart, Alex R.; Rooney, James F.; Andrew, Philip; Salata, Robert A.; Siegel, Marc; Manabe, Yukari C.; Frank, Ian; Ho, Ken; Santana, Jorge; Stekler, Joanne D.; Swaminathan, Shobha; McCauley, Marybeth; Hodder, Sally; Mayer, Kenneth H.

2017-01-01

BACKGROUND Maraviroc (MVC) is a candidate drug for HIV PrEP. OBJECTIVE To assess the safety/tolerability of MVC-containing PrEP in U.S. women at-risk for HIV over 48 weeks. DESIGN Phase 2 randomized, controlled, double-blinded study of four PrEP regimens (#NCT01505114). SETTING Twelve clinical research sites of the HIV Prevention Trials Network and AIDS Clinical Trials Group. PARTICIPANTS HIV-uninfected women reporting condomless vaginal or anal intercourse with ≥1 HIV-infected or unknown-serostatus man within 90 days. INTERVENTIONS MVC alone, MVC+emtricitabine (FTC), MVC+tenofovir disoproxil fumarate (TDF), and TDF+FTC (control). MEASUREMENTS At each visit, clinical and laboratory (including HIV) assessments were conducted. Primary outcomes were grade 3–4 adverse events and time to permanent regimen discontinuation. Analyses were conducted on all randomized participants, according to original regimen assignment. RESULTS Among 188 participants, 85% completed follow-up, 11% withdrew early, and 4% were lost-to-follow-up; 19% discontinued their regimen prematurely. Number discontinuing and time-to-discontinuation did not differ among regimens. Grade 3/4 adverse events occurred in 5 (MVC), 13 (MVC+FTC), 9 (MVC+TDF) and 8 (TDF+FTC) participants; rates did not differ among regimens. One death occurred (suicide; MVC+FTC), judged not regimen-related. Of available samples at week 48 (n=126), 60% demonstrated detectable drug concentrations. No new HIV infections occurred. LIMITATIONS Participants were not necessarily high-risk for HIV. Regimen was 3 pills daily. Study was not powered for efficacy. CONCLUSIONS MVC-containing PrEP regimens were safe and well-tolerated compared to the control regimen of TDF+FTC in U.S. women. No new HIV infections occurred, although whether this was due to low risk of the population or to protection from the study regimens is not certain. MVC-containing PrEP for women may warrant further study. FUNDING SOURCE U.S. National Institutes of Health PMID:28828489

Underlying Kidney Disease and Duration of Hemodialysis: An Assessment of Its Effect on Oral Health

PubMed Central

Singla, Ashish; Basavaraj, P.; Singh, Shilpi; Singh, Khushboo; Kundu, Hansa

2014-01-01

Background: Dental health among the patients undergoing haemodialysis therapy has been found to be debilitated and gets worsened with the increased duration of hemodialysis.Hence the present study aimed to assess the effect of duration of hemodialysis and the underlying kidney disease on the dental health status of patients. Settings and Design: A cross-sectional study was conducted on 400 patients and 400 controls selected through stratified random sampling method from five zones of Delhi, India. Materials and Methods: The patient group was divided into following five groups in order to evaluate influence of duration of hemodialysis therapy on dental status of the subjects-a)≤ three months b)four to six months c)seven to nine months d) ten to twelve months and e) more than twelve months. Dental health was assessed using WHO dentition status and treatment needs, community periodontal index, oral hygiene index, prosthetic status and needs. Statistical Analysis Used: Student t-test, Chi-square test, one-way analysis of variance (ANOVA) and Pearson’s correlation was used to determine the difference in clinical parameters among the subgroup and between the patients and controls. Results: Positive correlation was found between the frequency of dialysis and maximum CPI scores (p-value=0.018). 81.25% of patients and 74.75% of the controls had CPI score 2. Loss of attachment scores in patients was higher than the healthy controls (p-value 0.035). Mean OHI scores for the patients was 5.15±1.975 and for controls was 5.01±2.213 (p=0.635). Mean DMFT score of patients and controls was 3.552 and 3.559 respectively (p=0.937). 23%of controls showed presence of dental prosthesis in comparison to only 14.5 % of patients (p=0.05). Type of underlying kidney disease and duration of hemodialysis had significant influence on O.H.I scores and Prosthetic needs. Conclusion: Dental health status was found to be debilitated among the hemodialysis patients and got worsened with the duration of hemodialysis and the type of underlying kidney disease mainly due to oral health negligence contributing to morbidity and potential mortality. Further emphasis on the effective implementation of oral health promotion programme for medically compromised patients is thus advocated. PMID:24995249

Design and baseline characteristics of the PerfectFit study: a multicenter cluster-randomized trial of a lifestyle intervention in employees with increased cardiovascular risk.

PubMed

Kouwenhoven-Pasmooij, Tessa A; Djikanovic, Bosiljka; Robroek, Suzan J W; Helmhout, Pieter; Burdorf, Alex; Hunink, M G Myriam

2015-07-28

The prevalence of unhealthy lifestyles and preventable chronic diseases is high. They lead to disabilities and sickness absence, which might be reduced if health promotion measures were applied. Therefore, we developed the PerfectFit health promotion intervention with a "blended care"-approach, which consists of a web-based health risk assessment (HRA) including tailored and personalized advice, followed by motivational interviewing (MI). We hypothesize that adding MI to a web-based HRA leads to better health outcomes. The objective is to describe the design and baseline characteristics of the PerfectFit study, which is being conducted among employees with high cardiovascular risk in the military workforce, the police organization and an academic hospital. PerfectFit is a cluster randomized controlled trial, consisting of two arms. Based on cardiovascular risk profiling, done between 2012 and 2014, we included employees based on one or more risk factors and motivation to participate. One arm is the 'limited' health program (control) that consists of: (a) an HRA as a decision aid for lifestyle changes, including tailored and personalized advice, and pros and cons of the options, and (b) a newsletter every 3 months. The other arm is the 'extensive' program (intervention), which is additionally offered MI-sessions by trained occupational physicians, 4 face-to-face and 3 by telephone, and is offered more choices of health promotion activities in the HRA. During the follow-up period, participants choose the health promotion activities they personally prefer. After six and twelve months, outcomes will be assessed by online questionnaires. After twelve months the cardiovascular risk profiling will be repeated. The primary outcome is self-reported general health. Secondary outcomes are self-reported work ability, CVD-risk score, sickness absence, productivity loss at work, participation in health promotion activities, changes in lifestyle (smoking, alcohol consumption, physical activity, stress management) and body mass index. Furthermore, a process evaluation and an economic analysis will be performed. Additional coaching using MI is expected to be a key factor for success of the web-based HRA in employees with increased cardiovascular risk. This "blended care"-approach may be an essential strategy for effective health promotion activities. Dutch Trial Register by registration number NTR4894 , 14/11/2014.

Effects of 8-week sensory electrical stimulation combined with motor training on EEG-EMG coherence and motor function in individuals with stroke.

PubMed

Pan, Li-Ling Hope; Yang, Wen-Wen; Kao, Chung-Lan; Tsai, Mei-Wun; Wei, Shun-Hwa; Fregni, Felipe; Chen, Vincent Chiun-Fan; Chou, Li-Wei

2018-06-15

The peripheral sensory system is critical to regulating motor plasticity and motor recovery. Peripheral electrical stimulation (ES) can generate constant and adequate sensory input to influence the excitability of the motor cortex. The aim of this proof of concept study was to assess whether ES prior to each hand function training session for eight weeks can better improve neuromuscular control and hand function in chronic stroke individuals and change electroencephalography-electromyography (EEG-EMG) coherence, as compared to the control (sham ES). We recruited twelve subjects and randomly assigned them into ES and control groups. Both groups received 20-minute hand function training twice a week, and the ES group received 40-minute ES on the median nerve of the affected side before each training session. The control group received sham ES. EEG, EMG and Fugl-Meyer Assessment (FMA) were collected at four different time points. The corticomuscular coherence (CMC) in the ES group at fourth weeks was significantly higher (p = 0.004) as compared to the control group. The notable increment of FMA at eight weeks and follow-up was found only in the ES group. The eight-week rehabilitation program that implemented peripheral ES sessions prior to function training has a potential to improve neuromuscular control and hand function in chronic stroke individuals.

Fault Detection of Aircraft System with Random Forest Algorithm and Similarity Measure

PubMed Central

Park, Wookje; Jung, Sikhang

2014-01-01

Research on fault detection algorithm was developed with the similarity measure and random forest algorithm. The organized algorithm was applied to unmanned aircraft vehicle (UAV) that was readied by us. Similarity measure was designed by the help of distance information, and its usefulness was also verified by proof. Fault decision was carried out by calculation of weighted similarity measure. Twelve available coefficients among healthy and faulty status data group were used to determine the decision. Similarity measure weighting was done and obtained through random forest algorithm (RFA); RF provides data priority. In order to get a fast response of decision, a limited number of coefficients was also considered. Relation of detection rate and amount of feature data were analyzed and illustrated. By repeated trial of similarity calculation, useful data amount was obtained. PMID:25057508

A retrospective survey of the quality of reports and their correlates among randomized controlled trials of immunotherapy for Guillain-Barré syndrome.

PubMed

Lu, Liming; Luo, Gaoquan; Xiao, Fang

2013-08-01

This study aims to assess the quality of reports and their correlates in randomized controlled trials (RCTs) of immunotherapy for Guillain-Barré syndrome (GBS). A search was performed in multiple databases of reports published between April 1992 and November 2012. Reporting quality was assessed by items of the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement. An overall quality score (OQS) and a key methodological index score (MIS) were calculated for each trial. Factors associated with OQS and MIS were then identified. A total of 19 RCTs were included in the full text. The median OQS was 7.0, with a range of 1-10. However, the quality of reporting in items of 'flow chart' and 'ancillary analyses' was poor with a positive rate of less than 40%. The median MIS was 0 with a range of 0-2. Twelve (63.2%) did not report any of the three key methodological items. Specifically, the mean OQS increased by approximately 2.73 for manuscripts published in the New England Journal of Medicine, The Lancet, Pediatrics and Neurology (95% CI: 0.35-5.12; p < 0.05). Multivariate linear regression and the Poisson regression model could not be presented as the number of included trials was too small. The reporting quality in RCTs on immunotherapy for GBS was poor, which indicated that reporting in RCTs of immunotherapy for GBS needed substantial improvement in order to meet the guideline of the CONSORT Statement.

Mental health impact of social capital interventions: a systematic review.

PubMed

Flores, Elaine C; Fuhr, Daniela C; Bayer, Angela M; Lescano, Andres G; Thorogood, Nicki; Simms, Victoria

2018-02-01

Mental disorders are a major contributor to the global burden of disease and disability, and can be extremely costly at both individual and community level. Social capital, (SC) defined as an individual's social relationships and participation in community networks, may lower the risk of mental disorders while increasing resilience capacity, adaptation and recovery. SC interventions may be a cost-effective way of preventing and ameliorating these conditions. However, the impact of these SC interventions on mental health still needs research. We conducted a systematic review of SC-based interventions to investigate their effect on mental health outcomes from controlled, quasi-experimental studies or pilot trials. We searched twelve academic databases, three clinical trials registries, hand-searched references and contacted field experts. Studies' quality was assessed with the Cochrane Risk of Bias tools for randomized and non-randomized studies. Seven studies were included in the review, published between 2006 and 2016. There was substantial heterogeneity in the definitions of both SC and mental disorders among the studies, preventing us from calculating pooled effect sizes. The interventions included community engagement and educative programs, cognitive processing therapy and sociotherapy for trauma survivors, and neighbourhood projects. There are paucity of SC interventions investigating the effect on mental health outcomes. This study showed that both SC scores and mental health outcomes improved over time but there was little evidence of benefit compared to control groups in the long term. Further high-quality trials are needed, especially among adverse populations to assess sustainability of effect.

Prophylactic Cranial Irradiation May Impose a Detrimental Effect on Overall Survival of Patients with Nonsmall Cell Lung Cancer: A Systematic Review and Meta-Analysis

PubMed Central

Zhou, Cai-cun; Song, Xiao-lian; Wang, Chang-hui

2014-01-01

Purpose To determine the role of brain metastases (BM) and overall survival (OS) in patients with non-small cell lung cancer (NSCLC) by performing a meta-analysis of the RCTs (randomized controlled clinical trials) and non-RCTs (non-randomized controlled clinical trials) published in the literature. Methods A meta-analysis was performed using trials identified through PubMed, EMBASE and Cochrane databases. Two investigators independently assessed the quality of the trials and extracted data. The outcomes included BM, OS, median survival (MS), response rate (RR), Hazard ratios (HRs) and odds ratios (ORs), and their 95% confidence intervals (CIs) were pooled using ReMan software. Results Twelve trials (6 RCTs and 6 non-RCTs) involving 1,718 NSCLC patients met the inclusion criteria. They were grouped on the basis of study design for separate Meta-analyses. The results showed that prophylactic cranial irradiation (PCI) reduced the risk of BM as compared with non-PCI in NSCLC patients (OR = 0.30, 95% [CI]: 0.21–0.43, p<0.00001). However, HRs for OS favored non-PCI (HR = 1.19, 95% [CI]: 1.06–1.33, p = 0.004), without evidence of heterogeneity between the studies. Conclusion Our results suggest that although PCI decreased the risk of BM, it may impose a detrimental effect on OS of NSCLC patients. PMID:25072281

A systematic review and meta-analysis on herpes zoster and the risk of cardiac and cerebrovascular events

PubMed Central

Erskine, Nathaniel; Tran, Hoang; Levin, Leonard; Ulbricht, Christine; Fingeroth, Joyce; Kiefe, Catarina; Singh, Sonal

2017-01-01

Background Patients who develop herpes zoster or herpes zoster ophthalmicus may be at risk for cerebrovascular and cardiac complications. We systematically reviewed the published literature to determine the association between herpes zoster and its subtypes with the occurrence of cerebrovascular and cardiac events. Methods/Results Systematic searches of PubMed (MEDLINE), SCOPUS (Embase) and Google Scholar were performed in December 2016. Eligible studies were cohort, case-control, and self-controlled case-series examining the association between herpes zoster or subtypes of herpes zoster with the occurrence of cerebrovascular and cardiac events including stroke, transient ischemic attack, coronary heart disease, and myocardial infarction. Data on the occurrence of the examined events were abstracted. Odds ratios and their accompanying confidence intervals were estimated using random and fixed effects models with statistical heterogeneity estimated with the I2 statistic. Twelve studies examining 7.9 million patients up to 28 years after the onset of herpes zoster met our pre-defined eligibility criteria. Random and fixed effects meta-analyses showed that herpes zoster, type unspecified, and herpes zoster ophthalmicus were associated with a significantly increased risk of cerebrovascular events, without any evidence of statistical heterogeneity. Our meta-analysis also found a significantly increased risk of cardiac events associated with herpes zoster, type unspecified. Conclusions Our results are consistent with the accumulating body of evidence that herpes zoster and herpes zoster ophthalmicus are significantly associated with cerebrovascular and cardiovascular events. PMID:28749981

A systematic review and meta-analysis on herpes zoster and the risk of cardiac and cerebrovascular events.

PubMed

Erskine, Nathaniel; Tran, Hoang; Levin, Leonard; Ulbricht, Christine; Fingeroth, Joyce; Kiefe, Catarina; Goldberg, Robert J; Singh, Sonal

2017-01-01

Patients who develop herpes zoster or herpes zoster ophthalmicus may be at risk for cerebrovascular and cardiac complications. We systematically reviewed the published literature to determine the association between herpes zoster and its subtypes with the occurrence of cerebrovascular and cardiac events. Systematic searches of PubMed (MEDLINE), SCOPUS (Embase) and Google Scholar were performed in December 2016. Eligible studies were cohort, case-control, and self-controlled case-series examining the association between herpes zoster or subtypes of herpes zoster with the occurrence of cerebrovascular and cardiac events including stroke, transient ischemic attack, coronary heart disease, and myocardial infarction. Data on the occurrence of the examined events were abstracted. Odds ratios and their accompanying confidence intervals were estimated using random and fixed effects models with statistical heterogeneity estimated with the I2 statistic. Twelve studies examining 7.9 million patients up to 28 years after the onset of herpes zoster met our pre-defined eligibility criteria. Random and fixed effects meta-analyses showed that herpes zoster, type unspecified, and herpes zoster ophthalmicus were associated with a significantly increased risk of cerebrovascular events, without any evidence of statistical heterogeneity. Our meta-analysis also found a significantly increased risk of cardiac events associated with herpes zoster, type unspecified. Our results are consistent with the accumulating body of evidence that herpes zoster and herpes zoster ophthalmicus are significantly associated with cerebrovascular and cardiovascular events.

Effectiveness of a primary care-based intervention to reduce sitting time in overweight and obese patients (SEDESTACTIV): a randomized controlled trial; rationale and study design

PubMed Central

2014-01-01

Background There is growing evidence suggesting that prolonged sitting has negative effects on people’s weight, chronic diseases and mortality. Interventions to reduce sedentary time can be an effective strategy to increase daily energy expenditure. The purpose of this study is to evaluate the effectiveness of a six-month primary care intervention to reduce daily of sitting time in overweight and mild obese sedentary patients. Method/Design The study is a randomized controlled trial (RCT). Professionals from thirteen primary health care centers (PHC) will randomly invite to participate mild obese or overweight patients of both gender, aged between 25 and 65 years old, who spend 6 hours at least daily sitting. A total of 232 subjects will be randomly allocated to an intervention (IG) and control group (CG) (116 individuals each group). In addition, 50 subjects with fibromyalgia will be included. Primary outcome is: (1) sitting time using the activPAL device and the Marshall questionnaire. The following parameters will be also assessed: (2) sitting time in work place (Occupational Sitting and Physical Activity Questionnaire), (3) health-related quality of life (EQ-5D), (4) evolution of stage of change (Prochaska and DiClemente's Stages of Change Model), (5) physical inactivity (catalan version of Brief Physical Activity Assessment Tool), (6) number of steps walked (pedometer and activPAL), (7) control based on analysis (triglycerides, total cholesterol, HDL, LDL, glycemia and, glycated haemoglobin in diabetic patients) and (8) blood pressure and anthropometric variables. All parameters will be assessed pre and post intervention and there will be a follow up three, six and twelve months after the intervention. A descriptive analysis of all variables and a multivariate analysis to assess differences among groups will be undertaken. Multivariate analysis will be carried out to assess time changes of dependent variables. All the analysis will be done under the intention to treat principle. Discussion If the SEDESTACTIV intervention shows its effectiveness in reducing sitting time, health professionals would have a low-cost intervention tool for sedentary overweight and obese patients management. Trial registration A service of the U.S. National Institutes of Health. Developed by the National Library of Medicine. ClinicalTrials.gov NCT01729936 PMID:24597534

Effectiveness of a primary care-based intervention to reduce sitting time in overweight and obese patients (SEDESTACTIV): a randomized controlled trial; rationale and study design.

PubMed

Martín-Borràs, Carme; Giné-Garriga, Maria; Martínez, Elena; Martín-Cantera, Carlos; Puigdoménech, Elisa; Solà, Mercè; Castillo, Eva; Beltrán, Angela Ma; Puig-Ribera, Anna; Trujillo, José Manuel; Pueyo, Olga; Pueyo, Javier; Rodríguez, Beatriz; Serra-Paya, Noemí

2014-03-05

There is growing evidence suggesting that prolonged sitting has negative effects on people's weight, chronic diseases and mortality. Interventions to reduce sedentary time can be an effective strategy to increase daily energy expenditure. The purpose of this study is to evaluate the effectiveness of a six-month primary care intervention to reduce daily of sitting time in overweight and mild obese sedentary patients. The study is a randomized controlled trial (RCT). Professionals from thirteen primary health care centers (PHC) will randomly invite to participate mild obese or overweight patients of both gender, aged between 25 and 65 years old, who spend 6 hours at least daily sitting. A total of 232 subjects will be randomly allocated to an intervention (IG) and control group (CG) (116 individuals each group). In addition, 50 subjects with fibromyalgia will be included.Primary outcome is: (1) sitting time using the activPAL device and the Marshall questionnaire. The following parameters will be also assessed: (2) sitting time in work place (Occupational Sitting and Physical Activity Questionnaire), (3) health-related quality of life (EQ-5D), (4) evolution of stage of change (Prochaska and DiClemente's Stages of Change Model), (5) physical inactivity (catalan version of Brief Physical Activity Assessment Tool), (6) number of steps walked (pedometer and activPAL), (7) control based on analysis (triglycerides, total cholesterol, HDL, LDL, glycemia and, glycated haemoglobin in diabetic patients) and (8) blood pressure and anthropometric variables. All parameters will be assessed pre and post intervention and there will be a follow up three, six and twelve months after the intervention. A descriptive analysis of all variables and a multivariate analysis to assess differences among groups will be undertaken. Multivariate analysis will be carried out to assess time changes of dependent variables. All the analysis will be done under the intention to treat principle. If the SEDESTACTIV intervention shows its effectiveness in reducing sitting time, health professionals would have a low-cost intervention tool for sedentary overweight and obese patients management. A service of the U.S. National Institutes of Health. Developed by the National Library of Medicine. ClinicalTrials.gov NCT01729936.

Virtual reality to augment robot-assisted gait training in non-ambulatory patients with a subacute stroke: a pilot randomized controlled trial.

PubMed

Bergmann, Jeannine; Krewer, Carmen; Bauer, Petra; Koenig, Alexander; Riener, Robert; Müller, Friedemann

2018-06-01

Active performance is crucial for motor learning, and, together with motivation, is believed to be associated with a better rehabilitation outcome. Virtual reality (VR) is an innovative approach to engage and motivate patients during training. There is promising evidence for its efficiency in retraining upper limb function. However, there is insufficient proof for its effectiveness in gait training. To evaluate the acceptability of robot-assisted gait training (RAGT) with and without VR and the feasibility of potential outcome measures to guide the planning of a larger randomized controlled trial (RCT). Single-blind randomized controlled pilot trial with two parallel arms. Rehabilitation hospital. Twenty subacute stroke patients (64±9 years) with a Functional Ambulation Classification (FAC) ≤2. Twelve sessions (over 4 weeks) of either VR-augmented RAGT (intervention group) or standard RAGT (control group). Acceptability of the interventions (drop-out rate, questionnaire), patients' motivation (Intrinsic Motivation Inventory [IMI], individual mean walking time), and feasibility of potential outcome measures (completion rate and response to interventions) were determined. We found high acceptability of repetitive VR-augmented RAGT. The drop-out rate was 1/11 in the intervention and 4/14 in the control group. Patients of the intervention group spent significantly more time walking in the robot than the control group (per session and total walking time; P<0.03). In both groups, motivation measured with the IMI was high over the entire intervention period. The felt pressure and tension significantly decreased in the intervention group (P<0.01) and was significantly lower than in the control group at the last therapy session (r=-0.66, P=0.005). The FAC is suggested as a potential primary outcome measure for a definitive RCT, as it could be assessed in all patients and showed significant response to interventions (P<0.01). We estimated a sample size of 44 for a future RCT. VR-augmented RAGT resulted in high acceptability and motivation, and in a reduced drop-out rate and an extended training time compared to standard RAGT. This pilot trial provides guidance for a prospective RCT on the effectiveness of VR-augmented RAGT. VR might be a promising approach to enrich and improve gait rehabilitation after stroke.

The digestive system of 1-week old Jersey calves is well suited to digest, absorb, and incorporate protein and energy into tissue growth even when fed a high plane of milk replacer.

USDA-ARS?s Scientific Manuscript database

The objectives of the current study were to determine the digestibilities of nutrients as well as investigate the nitrogen retention of calves fed different planes of milk replacer nutrition during the first week of life. Twelve Jersey calves were blocked by body weight at birth and randomly assigne...

Anterior rectopexy for full-thickness rectal prolapse: Technical and functional results

PubMed Central

Faucheron, Jean-Luc; Trilling, Bertrand; Girard, Edouard; Sage, Pierre-Yves; Barbois, Sandrine; Reche, Fabian

2015-01-01

AIM: To assess effectiveness, complications, recurrence rate, and recent improvements of the anterior rectopexy procedure for treatment of total rectal prolapse. METHODS: MEDLINE, PubMed, EMBASE, and other relevant database were searched to identify studies. Randomized controlled trials, non-randomized studies and original articles in English language, with more than 10 patients who underwent laparoscopic ventral rectopexy for full-thickness rectal prolapse, with a follow-up over 3 mo were considered for the review. RESULTS: Twelve non-randomized case series studies with 574 patients were included in the review. No surgical mortality was described. Conversion was needed in 17 cases (2.9%), most often due to difficult adhesiolysis. Twenty eight patients (4.8%) presented with major complications. Seven (1.2%) mesh-related complications were reported. Most frequent complications were urinary tract infection and urinary retention. Mean recurrence rate was 4.7% with a median follow-up of 23 mo. Improvement of constipation ranged from 3%-72% of the patients and worsening or new onset occurred in 0%-20%. Incontinence improved in 31%-84% patients who presented fecal incontinence at various stages. Evaluation of functional score was disparate between studies. CONCLUSION: Based on the low long-term recurrence rate and favorable outcome data in terms of low de novo constipation rate, improvement of anal incontinence, and low complications rate, laparoscopic anterior rectopexy seems to emerge as an efficient procedure for the treatment of patients with total rectal prolapse. PMID:25945021

Impact of effective versus sham continuous positive airway pressure on liver injury in obstructive sleep apnoea: Data from randomized trials.

PubMed

Jullian-Desayes, Ingrid; Tamisier, Renaud; Zarski, Jean-Pierre; Aron-Wisnewsky, Judith; Launois-Rollinat, Sandrine H; Trocme, Candice; Levy, Patrick; Joyeux-Faure, Marie; Pepin, Jean-Louis

2016-02-01

Obstructive sleep apnoea (OSA) could be an independent risk factor for non-alcoholic fatty liver disease (NAFLD) occurrence and progression. The impact of continuous positive airway pressure (CPAP) treatment on non-invasive markers of NAFLD has not been studied. The aim of this study was to evaluate the effect of 6-12 weeks of effective CPAP on the FibroMax test (comprising components including the SteatoTest, NashTest and FibroTest) through three randomized sham controlled studies. The FibroMax test was performed in 103 obstructive sleep apnoea patients (apnoea + hypopnoea index > 15/h) enrolled in a randomized study comparing sham versus effective CPAP. At baseline, 40.4% of patients in the sham CPAP group and 45.5% in the CPAP group exhibited liver steatosis. Furthermore, 39.6% of patients in the sham CPAP group and 58.4% in the CPAP group displayed borderline or possible non-alcoholic steatohepatitis (NASH). Six to twelve weeks of effective CPAP did not demonstrate any impact on reducing steatosis, NASH or liver fibrosis even after adjustment for gender, BMI, baseline apnoea + hypopnoea index and severity of liver injury. A number of non-invasive markers of liver damage are increased in untreated obstructive sleep apnoea patients, potentially contributing to cardiometabolic risk, but they do not improve after 6-12 weeks of effective CPAP treatment. NCT01196845 (ADISAS), NCT00464659 (MneSAS) and NCT00669695 (StatinflaSAS) at ClinicalTrials.gov. © 2015 Asian Pacific Society of Respirology.

Evaluating a selective prevention program for substance use and comorbid behavioral problems in adolescents with mild to borderline intellectual disabilities: Study protocol of a randomized controlled trial.

PubMed

Schijven, Esmée P; Engels, Rutger C M E; Kleinjan, Marloes; Poelen, Evelien A P

2015-07-22

Substance use and abuse is a growing problem among adolescents with mild to borderline intellectual disabilities (ID). Substance use patterns in general population are similar to patterns among non-disabled peers, but substance use has more negative consequences for adolescents with mild to borderline ID, and they are at an increased risk for developing a substance use disorder. Nevertheless, effective and evidence based prevention programs for this groups are lacking. The study described in this protocol tested the effectiveness of a selective intervention aimed at reducing substance use in adolescents with mild to borderline ID and behavioral problems. In the intervention, participants acquire competences to deal with their high-risk personality traits. A randomized controlled trial will be conducted among 14-21-year old adolescents with mild to borderline ID and behavioral problems admitted to treatment facilities in the Netherlands. Inclusion criteria are previous substance use and personality risk for substance use. Participants will be individually randomized to the intervention (n = 70) or control (n = 70) groups. The intervention group will be exposed to six individual sessions and five group sessions carried out by two qualified trainers over six-week period. Primary outcomes will be the percentage reduction in substance use (for alcohol: percentage decrease of binge drinking, weekly use and problematic use, for cannabis: the percentage decrease of lifetime cannabis use and weekly use and for hard drug: the percentage decrease of lifetime use). Secondary outcomes will be motives for substance use, intention to use, and internalizing and externalizing behavioral problems. All outcome measures will be assessed after two, six, and twelve months after the intervention. This study protocol describes the design of an effectiveness study of a selective prevention program for substance use in adolescents with mild to borderline ID and behavioral problems. We expect a significant reduction in alcohol, cannabis and hard drug use among adolescents in the intervention group compared with the control group. This trial is registered in the Dutch Trial Register (Cochrane Collaboration) as NTR5037 registered at 15 April 2015.

Moxibustion for the treatment of chemotherapy-induced leukopenia: a systematic review of randomized clinical trials.

PubMed

Choi, Tae-Young; Lee, Myeong Soo; Ernst, Edzard

2015-06-01

The purpose of this study is to assess the efficacy of moxibustion as a treatment of chemotherapy-induced leukopenia. Twelve databases were searched from their inception through June 2014, without a language restriction. Randomized clinical trials (RCTs) were included if moxibustion was used as the sole treatment or as a part of a combination therapy with conventional drugs for leukopenia induced by chemotherapy. Cochrane criteria were used to assess the risk of bias. Six RCTs with a total of 681 patients met our inclusion criteria. All of the included RCTs were associated with a high risk of bias. The trials included patients with various types of cancer receiving ongoing chemotherapy or after chemotherapy. The results of two RCTs suggested the effectiveness of moxibustion combined with chemotherapy vs. chemotherapy alone. In four RCTs, moxibustion was more effective than conventional drug therapy. Six RCTs showed that moxibustion was more effective than various types of control interventions in increasing white blood cell counts. There is low level of evidence based on these six trials that demonstrates the superiority of moxibustion over drug therapies in the treatment of chemotherapy-induced leukopenia. However, the number of trials, the total sample size, and the methodological quality are too low to draw firm conclusions. Future RCTs appear to be warranted.

Cognitive rehabilitation with right hemifield eye-patching for patients with sub-acute stroke and visuo-spatial neglect: a randomized controlled trial.

PubMed

Aparicio-López, Celeste; García-Molina, Alberto; García-Fernández, Juan; Lopez-Blazquez, Raquel; Enseñat-Cantallops, Antonia; Sánchez-Carrión, Rocío; Muriel, Vega; Tormos, Jose María; Roig-Rovira, Teresa

2015-01-01

To assess whether, following a right-hemisphere stroke, the combined administration of computer-based cognitive rehabilitation and right hemifield eye-patching in patients with visuo-spatial neglect is more effective than computer-based cognitive rehabilitation alone. Twelve patients were randomized into two treatment groups: a single treatment group (n = 7) and a combination treatment group (n = 5). In both cases, the treatment consisted of a mean number of 15 sessions, each lasting 1 hour. Visuo-spatial neglect was assessed using a specific exploration protocol (Bell Cancellation Test, Figure Copying of Odgen, Line Bisection, Baking Tray Task and Reading Task). The functional effects of the treatment were assessed using the Catherine Bergego Scale. Significant between-group differences were observed when comparing the pre- and post-treatment scores for the Reading Task. No differences were observed in either group in the Catherine Bergego Scale administered at baseline and at the final intervention. The results obtained do not allow one to conclude that the combination treatment with cognitive rehabilitation and right hemifield eye-patching is more effective than cognitive rehabilitation alone. Although partial improvement in the performance of neuropsychological tests was observed, this improvement is not present at functional level.

The acute effect of pleasurable music on craving for alcohol: A pilot crossover study.

PubMed

Mathis, Walter S; Han, Xiaotong

2017-07-01

Chronic administration of drugs of abuse leads to a dopamine deficient state in the mesolimbic system, causing dysphoria in abstinence and contributing to craving and return to use. Recent functional imaging studies have shown that listening to personally pleasing music activates the mesolimbic reward system in a fashion similar to drugs of abuse. It has been proposed that such activation could ameliorate the dysphoria and craving of the hypodopaminergic state. The present study sought to evaluate the efficacy of listening to personally pleasing or moving music on reducing craving in abstinent alcoholics using a single-blind, within-subject randomized block design, with three randomly determined presentations of each condition. Twelve participants with Alcohol Use Disorder on a residential substance rehabilitation unit reported their level of craving with a Visual Analog Scale before and after listening to either the participant-selected song or white noise. Using a mixed model to analyze the crossover design, the music intervention was found to have a statistically significant advantage in craving reduction compared to the noise control. Our results indicate that personally pleasing music might have a role in augmenting substance use disorder treatment via craving reduction. Further study is warranted to elucidate factors which predict the most robust response from this intervention. Copyright © 2017 Elsevier Ltd. All rights reserved.

Robotic tilt table reduces the occurrence of orthostatic hypotension over time in vegetative states.

PubMed

Taveggia, Giovanni; Ragusa, Ivana; Trani, Vincenzo; Cuva, Daniele; Angeretti, Cristina; Fontanella, Marco; Panciani, Pier Paolo; Borboni, Alberto

2015-06-01

The aim of this study is to evaluate the effects of verticalization with or without combined movement of the lower limbs in patients in a vegetative state or a minimally conscious state. In particular, we aimed to study whether, in the group with combined movement, there was better tolerance to verticalization. This was a randomized trial conducted in a neurorehabilitation hospital. Twelve patients with vegetative state and minimally conscious state 3-18 months after acute acquired brain injuries were included. Patients were randomized into A and B treatment groups. Study group A underwent verticalization with a tilt table at 65° and movimentation of the lower limbs with a robotic system for 30 min three times a week for 24 sessions. Control group B underwent the same rehabilitation treatment, with a robotic verticalization system, but an inactive lower-limb movement system. Systolic and diastolic blood pressure and heart rate were determined. Robotic movement of the lower limbs can reduce the occurrence of orthostatic hypotension in hemodynamically unstable patients. Despite the small number of patients involved (only eight patients completed the trial), our results indicate that blood pressures and heart rate can be stabilized better (with) by treatment with passive leg movements in hemodynamically unstable patients.

Breakfast consumption and exercise interact to affect cognitive performance and mood later in the day. A randomized controlled trial.

PubMed

Veasey, R C; Gonzalez, J T; Kennedy, D O; Haskell, C F; Stevenson, E J

2013-09-01

The current study assessed the interactive effect of breakfast and exercise on cognition and mood. Twelve active males completed four trials; no breakfast-rest, breakfast-rest, no breakfast-exercise or breakfast-exercise in a randomized, cross-over design. The trials consisted of; breakfast or fast, a 2h rest, exercise (treadmill run) or equivalent rest, a chocolate milk drink, a 90 min rest and an ad libitum lunch. Cognitive performance and mood were recorded frequently throughout each trial. Data was analysed as pre-exercise/rest, during and immediately post exercise/rest and post-drink. No effects were found prior to consumption of the drink. Post-drink, fasting before exercise increased mental fatigue compared to consuming breakfast before exercise and fasting before rest. Tension increased when breakfast was consumed at rest and when exercise was undertaken fasted compared to omitting breakfast before rest. Breakfast before rest decreased rapid visual information processing task speed and impaired Stroop performance. Breakfast omission improved Four Choice Reaction Time performance. To conclude, breakfast before exercise appeared beneficial for post-exercise mood even when a post-exercise snack was consumed. Exercise reversed post-breakfast cognitive impairment in active males. Copyright © 2013 Elsevier Ltd. All rights reserved.

Hip-Hop to Health Jr. for Latino preschool children.

PubMed

Fitzgibbon, Marian L; Stolley, Melinda R; Schiffer, Linda; Van Horn, Linda; KauferChristoffel, Katherine; Dyer, Alan

2006-09-01

Hip-Hop to Health Jr. was a diet/physical activity intervention designed to reduce gains in BMI (kilograms per meter squared) in preschool minority children. Twelve predominantly Latino Head Start centers participated in a group-randomized trial conducted between Fall 2001 and Winter 2003. Six centers were randomized to a culturally proficient 14-week (three times weekly) diet/physical activity intervention. Parents participated by completing weekly homework assignments. The children in the other six centers received a general health intervention that did not address either diet or physical activity. The primary outcome was change in BMI, and secondary outcomes were changes in dietary intake and physical activity. Measures were collected at baseline, post-intervention, and at Years 1 and 2 follow-up. There were no significant differences between intervention and control schools in either primary or secondary outcomes at post-intervention, Year 1, or Year 2 follow-ups. When Hip-Hop to Health Jr. was conducted in predominantly black Head Start centers, it was effective in reducing subsequent increases in BMI in preschool children. In contrast, when the program was conducted in Latino centers, it was not effective. Although the intervention did not prevent excessive weight gain in Latino children, it was very well received. Future interventions with this population may require further cultural tailoring and a more robust parent intervention.

Effects of 7.5% CO2 challenge in generalized anxiety disorder.

PubMed

Seddon, Kate; Morris, Kelly; Bailey, Jayne; Potokar, John; Rich, Ann; Wilson, Sue; Bettica, Paolo; Nutt, David J

2011-01-01

We have previously developed a putative model of generalized anxiety disorder in healthy volunteers using a 20-minute 7.5% carbon dioxide (CO(2)) inhalation challenge. The aim of this study was to validate the 7.5% CO(2) paradigm by assessing its effects in patients with generalized anxiety disorder in a test-retest design. Twelve medication-free generalized anxiety disorder patients attended our lab for two study days. On each study day placebo (compressed air) and 7.5% CO(2) mixture were randomly administered over 20 min, at least 30 min apart, in a single blind, randomized, placebo-controlled cross-over design. Subjective ratings, cardiovascular measures and cortisol levels were collected throughout. CO(2) challenge significantly increased ratings for anxiety and other subjective symptoms associated with generalized anxiety disorder, compared with air. It also significantly increased systolic blood pressure on day 2, indicating increased autonomic arousal. There was no change between the two test days in mean anxiety rating scores, and there also appeared to be a correlation for individual scores on a number of the subjective measures. In conclusion, 20 min of 7.5% CO(2) gas inhalation increases anxiety responses in patients with generalized anxiety disorder, and this is reliable over time.

Biological Communities and Geomorphology of Patch Reefs in Biscayne National Park, Florida, U.S.A.

USGS Publications Warehouse

Kuffner, Ilsa B.; Brock, John C.; Grober-Dunsmore, Rikki; Hickey, T. Don; Bonito, Victor; Bracone, Jeremy E.; Wright, C. Wayne

2008-01-01

Coral reef ecosystem management benefits from continual, quantitative assessment of the resources being managed, plus assessment of factors that affect distribution patterns of organisms in the ecosystem. In this study, we investigated the relationships among physical, benthic, and fish variables in effort to help explain the distribution patterns of ecologically and economically important species on twelve patch reefs within Biscayne National Park (BNP), Florida, U.S.A. We visited 196 randomly-located sampling stations across twelve shallow (< 10m) patch reefs, using SCUBA to conduct our surveys. We measured physical variables (e.g., substratum type), estimated the percent cover of benthic community members (e.g., coral, algae), and counted and estimated mean size for each fish species observed. We also used high-density bathymetric data collected remotely via airborne laser surveying (Experimental Advanced Airborne Research Lidar (EAARL)) to calculate rugosity (bumpiness) of the reef habitat. Here we present our findings visually by graphing our quantitative community and physical structure data simultaneously in a GIS map format. You will see that biological organisms arrange themselves on each patch reef in a non-random manner. For example, many species of fish prefer to locate themselves in areas of the reef where the rugosity index is high. Rugose parts of the reef provide them with good hiding places from predators. These maps (and the data used to create them) are permanent records of the status of reef resources found on these twelve patch reefs in BNP as of September, 2003. The survey data found in the shapefile located on this CD product includes benthic percent cover data for algae, coral, encrusting invertebrates, and substratum type, in addition to gorgonian abundance and volume, total fish abundance and species richness, and specific counts for Acanthurids (surgeonfish), Scarids (parrotfish), Lutjanids (snappers), Haemulids (grunts), Serranids (groupers), and Pomacentrids (damselfish).

Are Locking Constructs in Distal Femoral Fractures Always Best? A Prospective Multicenter Randomized Controlled Trial Comparing the Less Invasive Stabilization System With the Minimally Invasive Dynamic Condylar Screw System.

PubMed

2016-01-01

The purpose of this clinical study is to determine whether the rate of fracture healing and fracture union, repaired with a locked device, will be as good as or better than standard nonlocking bicortical fixation in distal femoral fractures. Institutional review board-approved, multicenter prospective randomized controlled trial. Seven level 1 trauma centers across Canada. Fifty-two patients with distal femoral fractures (AO/OTA 33A1 to 33C2) were enrolled in the randomized trial. Twelve AO/OTA 33C3 fractures were excluded from the randomized trial but followed up as a nonrandomized cohort. Patients were treated through a standardized minimally invasive approach. Fractures were randomized 1:1 to treatment with the locked Less Invasive Stabilization System (LISS; Synthes, Paoli, PA) or the dynamic condylar screw (DCS). The nonrandomized cohort was treated at the surgeon's discretion. Primary outcomes were time to radiological union and number of delayed/nonunions at 12 months. Secondary outcomes were postoperative function and complications. Fifty-two patients were randomized including 34 women and 18 men. The mean age was 59 years. Twenty-eight patients were treated with the LISS and 24 with the DCS. There was no statistically significant difference between the LISS and the DCS in terms of the number of fractures healed, time to union, or functional scores. Complications and revisions were more common in the LISS group. There were 7 reoperations in the LISS group and one in the DCS group. Only 52% of the LISS group healed without intervention by 12 months compared with 91% in the DCS group. There was no advantage to the locking plate design in the management of distal femoral fractures in this study. The higher cost of the locking plates, challenges in technique, and lack of superiority have led the authors to discontinue the use of this lateral unicortical locking device in favor of other devices that allow locked or nonlocked bicortical fixation, articular compression, and bridging of the comminuted fracture segments. The cost-effective treatment for a subgroup or periarticular fractures may be a fixed-angle nonlocked device in patients with reasonable bone quality. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Oropharyngeal cleansing with 0.2% chlorhexidine for prevention of nosocomial pneumonia in critically ill patients: an open-label randomized trial with 0.01% potassium permanganate as control.

PubMed

Panchabhai, Tanmay S; Dangayach, Neha S; Krishnan, Anand; Kothari, Vatsal M; Karnad, Dilip R

2009-05-01

Oral cleansing with chlorhexidine decreases the incidence of nosocomial pneumonia in patients after cardiac surgery. However, evidence of its benefit in ICU patients is conflicting. Patients admitted to the ICU of an Indian tertiary care teaching hospital were randomized to twice-daily oropharyngeal cleansing with 0.2% chlorhexidine or 0.01% potassium permanganate (control) solution. Effects on the incidence of nosocomial pneumonia during ICU stay (primary outcome) and length of ICU stay and in-hospital mortality (secondary outcomes) were studied. Five hundred twelve patients were randomized to either the chlorhexidine group (n = 250) or the control group (n = 262). Of the 471 subjects who completed the protocol, nosocomial pneumonia developed in 16 of 224 subjects (7.1%) in the chlorhexidine group and 19 of 247 subjects (7.7%) in the control group (p = 0.82; relative risk, 0.93; 95% confidence interval, 0.49 to 1.76); intention-to-treat analysis of 21 patients in whom the cleansing protocol was not followed revealed similar results. There was no significant difference between the study and control groups in the median day of development of pneumonia (5.0 days: interquartile range [IQR], 3.0 to 7.7 vs 5.0 days: IQR, 3.0 to 6.0, respectively), median ICU stay (5.0 days: IQR, 3.0 to 8.0 vs 6.0 days: IQR, 3.0 to 8.0, respectively), and mortality (34.8% vs 28.3%, respectively). On subgroup analysis, there was no significant difference in the primary and secondary outcomes in patients on mechanical ventilation, tracheal intubation, and coma (Glasgow coma scale

The case-control design in veterinary sciences: A survey.

PubMed

Cullen, Jonah N; Sargeant, Jan M; Makielski, Kelly M; O'Connor, Annette M

2016-11-01

The case-control study design is deceptively simple. However, many design considerations influence the estimated effect measure. An investigation of case-control studies in the human health literature suggested that some of these considerations are not described in reports of case-control studies. Our hypothesis was that the majority of veterinary studies labeled as case-controls would be incident density designs, and many would not interpret the effect measure obtained from those studies as the rate ratio rather than the odds ratio. Reference databases were searched for author-designated case-control studies. A survey of 100 randomly selected studies was conducted to examine the different design options described and estimated effect measures. Of the 100 author-identified case-control studies, 83 assessed an exposure-outcome association and, of those, only 54 (65.1%) sampled the study population based on an outcome and would thus be considered case-control designs. Twelve studies were incidence density designs but none used this terminology. Of the studies that reported an odds ratio as the effect measure, none reported on additional considerations that would have enabled a more interpretable result. This survey indicated many case-control-labeled studies were not case-control designs and among case-control studies, key design aspects were not often described. The absence of information about study design elements and underlying assumptions in case-control studies limits the ability to establish the effect measured by the study and the evidentiary value of the study might be underestimated. Copyright © 2016 Elsevier B.V. All rights reserved.

A randomized controlled trial on the benefits and respiratory adverse effects of morphine for refractory dyspnea in patients with COPD: Protocol of the MORDYC study.

PubMed

Verberkt, C A; van den Beuken-van Everdingen, M H J; Franssen, F M E; Dirksen, C D; Schols, J M G A; Wouters, E F M; Janssen, D J A

2016-03-01

Dyspnea is one of the most reported symptoms of patients with advanced Chronic Obstructive Pulmonary Disease (COPD) and is often undertreated. Morphine has proven to be an effective treatment for dyspnea and is recommended in clinical practice guidelines, but questions concerning benefits and respiratory adverse effects remain. This study primarily evaluates the impact of oral sustained release morphine (morphine SR) on health-related quality of life and respiratory adverse effects in patients with COPD. Secondary objectives include the impact on exercise capacity, the relationship between description and severity of dyspnea and the presence of a clinically relevant response to morphine, and cost-effectiveness. A single-center, randomized, double blind, placebo controlled intervention study will be performed in 124 patients with COPD who recently completed a comprehensive pulmonary rehabilitation program. Participants will receive 20-30 mg/24h morphine SR or placebo for four weeks. After the intervention, participants will be followed for twelve weeks. Outcomes include: the COPD Assessment Test, six minute walking test, Multidimensional Dyspnea Scale and a cost diary. Furthermore, lung function and arterial blood gasses will be measured. These measures will be assessed during a baseline and outcome assessment, two home visits, two phone calls, and three follow-up assessments. The intervention and control group will be compared using uni- and multivariate regression analysis and logistic regression analysis. Finally, an economic evaluation will be performed from a societal and healthcare perspective. The current manuscript describes the rationale and methods of this study and provides an outline of the possible strengths, weaknesses and clinical consequences. Copyright © 2016 Elsevier Inc. All rights reserved.

Effects of aqueous extracts of dried calyx of sour tea (Hibiscus sabdariffa L.) on polygenic dyslipidemia: A randomized clinical trial.

PubMed

Hajifaraji, Majid; Matlabi, Mohammad; Ahmadzadeh-Sani, Farihe; Mehrabi, Yadollah; Rezaee, Mohammad Salem; Hajimehdipour, Homa; Hasanzadeh, Abbas; Roghani, Katayoun

2018-01-01

Dyslipidemia has been considered as a major risk factor for coronary heart disease. Alternative medicine has a significant role in treatment of dyslipidemia. There are controversial findings regarding the effects of sour tea on dyslipidemia. The aim of this study was to evaluate the impact of aqueous extract of dried calyx of sour tea on polygenic dyslipidemia. This clinical trial was done on 43 adults (30-60 years old) with polygenic dyslipidemia that were randomly assigned to the intervention and control groups. The control group was trained in lifestyle modifications at baseline. The intervention group was trained for lifestyle modifications at baseline and received two cups of sour tea daily, and both groups were followed up for 12 weeks. Lipid profile was evaluated at baseline, and six and 12 weeks following the intervention. In addition, dietary and physical activity assessed at baseline for twelve weeks. Mean concentration of total cholesterol, HDL-C and LDL-C significantly decreased by up to 9.46%, 8.33%, and 9.80%, respectively, after 12 weeks in the intervention group in comparison to their baseline values. However, LDL-C/HDL-C ratio significantly increased by up to 3.15%, following 12 weeks in the control group in comparison to their baseline values. This study showed no difference in lipid profiles between the two groups, except for HDL-C concentrations. sour tea may have significant positive effects on lipid profile of polygenic dyslipidemia subjects and these effect might be attributed to its anthocyanins and inflation factor content. Therefore, sour tea intake with recommended dietary patterns and physical activity can be useful in regulation of lipid profile in patients with polygenic dyslipidemia.

Results of a randomized controlled trial to increase cervical cancer screening among rural Latinas.

PubMed

Thompson, Beti; Carosso, Elizabeth A; Jhingan, Esther; Wang, Lei; Holte, Sarah E; Byrd, Theresa L; Benavides, Maria C; Lopez, Cathy; Martinez-Gutierrez, Javiera; Ibarra, Genoveva; Gonzalez, Virginia J; Gonzalez, Nora E; Duggan, Catherine R

2017-02-15

Latinas have the highest rates of cervical cancer in the United States and the second highest rate of cervical cancer mortality. One factor in the disparity is the relatively low rate of screening for cervical cancer in this population. Eligible women who were out of adherence with cervical cancer screening (>3 years since their last Papanicolaou [Pap] test) were identified via medical record review by a federally qualified local health center. The effects of a low-intensity intervention (video delivered to participants' homes; n = 150) and a high-intensity intervention (video plus a home-based educational session; n = 146) on cervical cancer screening uptake in comparison with a control arm (usual care; n = 147) were investigated. A cost-effectiveness analysis of the interventions was conducted: all intervention costs were calculated, and the incremental cost-effectiveness ratio was computed. Finally, women with positive Pap tests were provided navigation by a community health educator to ensure that they received follow-up care. A total of 443 Latinas participated. Seven months after randomization, significantly more women in the high-intensity arm received a Pap test (53.4%) in comparison with the low-intensity arm (38.7%; P < .001) and the usual-care arm (34.0%; P < .01). The incremental cost-effectiveness ratio for high-intensity women versus the control group amounted to $4.24. Twelve women had positive Pap tests, which encompassed diagnoses ranging from atypical squamous cells of unknown significance to invasive cancer; these women received navigation for follow-up care. A culturally appropriate, in-home, promotora-led educational intervention was successful in increasing cervical cancer screening among Latinas. Cancer 2017;123:666-674. © 2016 American Cancer Society. © 2016 American Cancer Society.

The Impact of Massage Therapy on Function in Pain Populations—A Systematic Review and Meta-Analysis of Randomized Controlled Trials: Part II, Cancer Pain Populations

PubMed Central

Boyd, Courtney; Crawford, Cindy; Paat, Charmagne F; Price, Ashley; Xenakis, Lea; Zhang, Weimin; Buckenmaier, Chester; Buckenmaier, Pamela; Cambron, Jerrilyn; Deery, Christopher; Schwartz, Jan; Werner, Ruth; Whitridge, Pete

2016-01-01

Abstract Purpose Pain is multi-dimensional and may be better addressed through a holistic, biopsychosocial approach. Massage therapy is commonly practiced among patients seeking pain management; however, its efficacy is unclear. This systematic review and meta-analysis is the first to rigorously assess the quality of massage therapy research and evidence for its efficacy in treating pain, function-related and health-related quality of life in cancer populations. Methods Key databases were searched from inception through February 2014. Eligible randomized controlled trials were assessed for methodological quality using the SIGN 50 Checklist. Meta-analysis was applied at the outcome level. A diverse steering committee interpreted the results to develop recommendations. Results Twelve high quality and four low quality studies were subsequently included in the review. Results demonstrate massage therapy is effective for treating pain compared to no treatment [standardized mean difference (SMD)  = −.20] and active (SMD = −0.55) comparators. Compared to active comparators, massage therapy was also found to be beneficial for treating fatigue (SMD = −1.06) and anxiety (SMD = −1.24). Conclusion Based on the evidence, weak recommendations are suggested for massage therapy, compared to an active comparator, for the treatment of pain, fatigue, and anxiety. No recommendations were suggested for massage therapy compared to no treatment or sham control based on the available literature to date. This review addresses massage therapy safety, research challenges, how to address identified research gaps, and necessary next steps for implementing massage therapy as a viable pain management option for cancer pain populations. PMID:27165967

The Impact of Massage Therapy on Function in Pain Populations-A Systematic Review and Meta-Analysis of Randomized Controlled Trials: Part II, Cancer Pain Populations.

PubMed

Boyd, Courtney; Crawford, Cindy; Paat, Charmagne F; Price, Ashley; Xenakis, Lea; Zhang, Weimin

2016-08-01

Pain is multi-dimensional and may be better addressed through a holistic, biopsychosocial approach. Massage therapy is commonly practiced among patients seeking pain management; however, its efficacy is unclear. This systematic review and meta-analysis is the first to rigorously assess the quality of massage therapy research and evidence for its efficacy in treating pain, function-related and health-related quality of life in cancer populations. Key databases were searched from inception through February 2014. Eligible randomized controlled trials were assessed for methodological quality using the SIGN 50 Checklist. Meta-analysis was applied at the outcome level. A diverse steering committee interpreted the results to develop recommendations. Twelve high quality and four low quality studies were subsequently included in the review. Results demonstrate massage therapy is effective for treating pain compared to no treatment [standardized mean difference (SMD)  = -.20] and active (SMD = -0.55) comparators. Compared to active comparators, massage therapy was also found to be beneficial for treating fatigue (SMD = -1.06) and anxiety (SMD = -1.24). Based on the evidence, weak recommendations are suggested for massage therapy, compared to an active comparator, for the treatment of pain, fatigue, and anxiety. No recommendations were suggested for massage therapy compared to no treatment or sham control based on the available literature to date. This review addresses massage therapy safety, research challenges, how to address identified research gaps, and necessary next steps for implementing massage therapy as a viable pain management option for cancer pain populations. © 2016 American Academy of Pain Medicine.

Effect of intervention using a messaging app on compliance and duration of treatment in orthodontic patients.

PubMed

Li, Xue; Xu, Zhen-Rui; Tang, Na; Ye, Cui; Zhu, Xiao-Ling; Zhou, Ting; Zhao, Zhi-He

2016-11-01

This study aims to determine the effectiveness of a messaging app (WeChat) in improving patients' compliance and reducing the duration of orthodontic treatment (DOT). A randomized controlled trial was performed in a dental hospital and a clinic from August 2012 to May 2015. Orthodontic patients were included at the beginning of treatment. Patients with multiphase treatment or braceless technique were excluded. Participants were randomized to WeChat group (received regular reminders and educational messages) or control group (received conventional management) and were followed up until the treatment was completed. Primary outcome measure was DOT. Others were late and failed attendance, bracket bond failure, and oral hygiene condition. One hundred twelve patients in each group participated and completed the trial. DOT in WeChat group were 7.3 weeks shorter (P = 0.007). There were less failed attendance (3.1 vs. 10.9 %, P < 0.001), late attendance (20.1 vs. 29.9 %, P < 0.001), and bracket bond failure (11.8 vs. 16.1 %, P < 0.001) in WeChat group than control. There was no difference in orthodontic plaque index nor modified gingivitis index between the two groups before and after treatment. Number of failed attendances was identified as an independent factor affecting DOT (P = 0.004; HR = 0.89, 95 % CI 0.84 to 0.95). The intervention with WeChat is effective in reducing the treatment duration and bracket bond failure, and improving the attendance in orthodontic patients. DOT can be reduced by improving patient's compliance. The messaging app is useful for outpatient education and management.

The HAPI 'Hip Arthroscopy Pre-habilitation Intervention' study: does pre-habilitation affect outcomes in patients undergoing hip arthroscopy for femoro-acetabular impingement?

PubMed

Grant, Louise F; Cooper, Derek J; Conroy, Jon L

2017-01-01

The purpose of this randomized prospective comparative controlled pilot study was to determine whether specific patient exercises done pre-hip arthroscopy surgery for femoro-acetabular impingement affected post-operative recovery. Between October 2013 and June 2014, 6 males and twelve females over the age of eighteen, who were listed for hip arthroscopy for femoro-acetabular impingement, were randomized into two groups. A hip-specific, 8-week home exercise programme was given to the experimental group before their surgery. The control group was given no instruction on exercise before surgery. All participants followed the same rehabilitation programme after surgery. Outcome measures were assessed at set time intervals. Hand held dynamometry was used to assess muscle strength, and the EQ-5D-5 L Score and the Non-Arthritic Hip Score were utilized. Sixteen participants completed the study (eight controls: mean age 41.75 years and eight intervention: mean age 37.5 years). A mixed ANCOVA analysis compared the treatment groups taking baseline values into account. A statistically significant difference was found between the treatment groups for knee extension strength on both operative ( P  = 0.05) and non-operative sides ( P  = 0.002), hip flexor strength operative side ( P  = 0.02) and for EQ-5D-5 L health ( P  = 0.03), in favour of the intervention group. There was no significant difference between the treatment groups for the other measures, although some tended towards significance. This small pilot study has been designed to aid the further research and the differences between the groups found in these results may inform future larger scale studies.

The HAPI ‘Hip Arthroscopy Pre-habilitation Intervention’ study: does pre-habilitation affect outcomes in patients undergoing hip arthroscopy for femoro-acetabular impingement?

PubMed Central

Cooper, Derek J.; Conroy, Jon L.

2017-01-01

Abstract The purpose of this randomized prospective comparative controlled pilot study was to determine whether specific patient exercises done pre-hip arthroscopy surgery for femoro-acetabular impingement affected post-operative recovery. Between October 2013 and June 2014, 6 males and twelve females over the age of eighteen, who were listed for hip arthroscopy for femoro-acetabular impingement, were randomized into two groups. A hip-specific, 8-week home exercise programme was given to the experimental group before their surgery. The control group was given no instruction on exercise before surgery. All participants followed the same rehabilitation programme after surgery. Outcome measures were assessed at set time intervals. Hand held dynamometry was used to assess muscle strength, and the EQ-5D-5 L Score and the Non-Arthritic Hip Score were utilized. Sixteen participants completed the study (eight controls: mean age 41.75 years and eight intervention: mean age 37.5 years). A mixed ANCOVA analysis compared the treatment groups taking baseline values into account. A statistically significant difference was found between the treatment groups for knee extension strength on both operative (P = 0.05) and non-operative sides (P = 0.002), hip flexor strength operative side (P = 0.02) and for EQ-5D-5 L health (P = 0.03), in favour of the intervention group. There was no significant difference between the treatment groups for the other measures, although some tended towards significance. This small pilot study has been designed to aid the further research and the differences between the groups found in these results may inform future larger scale studies. PMID:28630726

[Effects of chronic partial sleep deprivation on growth and learning/memory in young rats].

PubMed

Jiang, Fan; Shen, Xiao-Ming; Li, Sheng-Hui; Cui, Mao-Long; Zhang, Yin; Wang, Cheng; Yu, Xiao-Gang; Yan, Chong-Huai

2009-02-01

The effects of sleep deprivation on the immature brain remain unknown. Based on a computer controlled chronic sleep deprivation animal model, the effects of chronic partial sleep deprivation on growth, learning and memory in young rats were explored. Twelve weaned male Spraque-Dawley rats (3-week-old) were randomly divided into sleep deprivation, test control and blank control groups. Sleep deprivation was performed using computer-controlled "disc-over-water" technique at 8-11 am daily, for 14 days. The temperature and weights were measured every 7 days. Morris water maze was used to test spatial learning and memory abilities before and 7 and 14 days after sleep deprivation. After 14 days of sleep deprivation, the rats were sacrificed for weighting their major organs. After 14 days of sleep deprivation, the rats' temperature increased significantly. During the sleep deprivation, the rate of weight gain in the sleep deprivation group was much slower than that in the test control and blank control groups. The thymus of the rats subjected to sleep deprivation was much lighter than that of the blank control group. After 7 days of sleep deprivation, the rats showed slower acquisition of reference memory, but were capable of successfully performing the task by repeated exposure to the test. Such impairment of reference memory was not seen 14 days after sleep deprivation. Chronic sleep deprivation can affect growth of immature rats, as well as their abilities to acquire spatial reference memory.

Twelve-Month Efficacy and Safety Data for the "Stress Incontinence Control, Efficacy and Safety Study": A Phase III, Multicenter, Prospective, Randomized, Controlled Study Treating Female Stress Urinary Incontinence Using the Vesair Intravesical Balloon.

PubMed

Winkler, Harvey; Jacoby, Karny; Kalota, Susan; Snyder, Jeffrey; Cline, Kevin; Robertson, Kaiser; Kahan, Randall; Green, Lonny; McCammon, Kurt; Rovner, Eric; Rardin, Charles

The "Stress Incontinence Control, Efficacy and Safety Study" (SUCCESS) is a phase III study of the Vesair Balloon in women with stress urinary incontinence who had failed conservative therapy, and either failed surgery, were not candidates for surgery, or chose not to have surgery. The safety and efficacy of the balloon at 12 months is reported for those participants in the treatment arm who elected to continue with the SUCCESS trial beyond the primary end point at 3 months. The SUCCESS trial is a multicenter, prospective, single-blinded, randomized, sham-controlled study. Participants were randomized on a 2.33:1 basis to either Vesair Balloon placement or placebo. The primary efficacy end point was a composite of both a greater than 50% reduction from baseline on 1-hour provocative pad weight test and an at least 10-point improvement in symptoms on the Incontinence Quality of Life questionnaire assessed at the 3-month study visit. Patients in the treatment arm who opted to continue in the trial were followed up prospectively up to 12 months. A total of 221 participants were randomized, including 157 in the treatment arm and 64 in the control arm. Sixty-seven participants in the treatment arm (42.7% of participants enrolled) were evaluated at 12 months, with 56.3% achieving the composite end point and 78.7% having greater than 50% reduction in pad weight from baseline in a per-protocol analysis. In an intent-to-treat analysis treating all participants who did not continue with the balloon as failures, 24% of the participants achieved the composite end point and 33.6% had a greater than 50% reduction in pad weight from baseline. Treatment-related adverse events in this group included dysuria (40.1%), gross hematuria (36.9%), and urinary tract infection (26.1%). In this phase III trial, symptom relief was maintained for those participants who continued therapy for 12 months. The balloon was found to be safe with no device- or procedure-related serious adverse events reported. Additional studies are warranted to determine which patient populations are more tolerant of the balloon and to assess the efficacy and safety of its longer-term use. Additional screening methods, including screening patients for balloon tolerability, are warranted to reduce participant withdrawals.

A 72-hour study to test the efficacy and safety of the "Mucus Slurper" in mechanically ventilated sheep.

PubMed

Li Bassi, Gianluigi; Curto, Francesco; Zanella, Alberto; Stylianou, Mario; Kolobow, Theodor

2007-03-01

In patients intubated with endotracheal tubes (ETTs), suctioning is routinely performed to remove mucus from within the ETT and trachea. The Mucus Slurper is a novel ETT with built-in suction ports arranged radially at its tip. We evaluated the safety and efficacy of the Mucus Slurper, compared with conventional tracheal suction, to prevent airway obstruction in sheep with the ETT and trachea oriented below horizontal. Prospective randomized animal study. Animal research facility at the National Institutes of Health. Twelve healthy sheep. Sheep were randomized to be intubated with either the Mucus Slurper (study group) or a Hi-Lo Tracheal Tube (Mallinckrodt, St. Louis, MO) (control group) and mechanically ventilated for 72 hrs. In the study group, automatic, timed tracheal aspiration lasted 0.3 secs, was repeated every 2 mins, and was synchronized with the early expiratory phase. In the control group, tracheal suction was performed every 6 hrs or as required. In the control group, tracheal secretions accumulated progressively within the ETT and the trachea. In the study group, all mucus that reached the tip of the Mucus Slurper was aspirated, keeping the lumen of the ETT, and proximal trachea, free from secretions. In the study group, expiratory water trap protein concentration, a crude index to measure mucus drainage through the ETT, was consistently less than the control group (p < .001). At autopsy, no macroscopic injury to the tracheal mucosa was found in either group. In the study group, the respiratory circuit was less colonized than in the control group. There were no statistically significant differences between the two groups in bacterial colonization of the lungs/bronchi. The Mucus Slurper, combined with orientation of the trachea below horizontal, prevents accumulation of secretions within the lumen of the ETT and trachea, without need for conventional tracheal suctioning.

Switching patients with acromegaly from octreotide to pasireotide improves biochemical control: crossover extension to a randomized, double-blind, Phase III study.

PubMed

Bronstein, Marcello D; Fleseriu, Maria; Neggers, Sebastian; Colao, Annamaria; Sheppard, Michael; Gu, Feng; Shen, Chiung-Chyi; Gadelha, Mônica; Farrall, Andrew J; Hermosillo Reséndiz, Karina; Ruffin, Matthieu; Chen, YinMiao; Freda, Pamela

2016-04-02

Many patients with acromegaly do not achieve biochemical control with first-generation somatostatin analogues. A large, multicenter, randomized, Phase III core study demonstrated that pasireotide LAR had significantly superior efficacy over octreotide LAR. This analysis explores the efficacy and safety of switching therapeutic arms in inadequately controlled patients during a 12-month crossover extension. Patients with inadequate biochemical control (GH ≥2.5 μg/L and/or IGF-1 > ULN) at end of core study (month 12) were eligible to switch to pasireotide LAR 40 mg/28 days (n = 81) or octreotide LAR 20 mg/28 days (n = 38). One dose escalation to pasireotide LAR 60 mg/28 days or octreotide LAR 30 mg/28 days was permitted, but not mandatory, at month 17 or 20. Twelve months after crossover, 17.3 % of pasireotide LAR and 0 % of octreotide LAR patients achieved GH <2.5 μg/L and normal IGF-1 (main outcome measure); 27.2 and 5.3 % of pasireotide LAR and octreotide LAR patients achieved normal IGF-1, respectively; 44.4 and 23.7 % of pasireotide LAR and octreotide LAR patients achieved GH <2.5 μg/L, respectively. Mean (±SD) tumor volume further decreased from the end of the core study by 25 % (±25) and 18 % (±28); 54.3 % of pasireotide LAR and 42.3 % of octreotide LAR patients achieved significant (≥20 %) tumor volume reduction during the extension. The safety profile of pasireotide LAR was similar to that of octreotide LAR, with the exception of the frequency and degree of hyperglycemia-related adverse events. Pasireotide LAR is a promising treatment option for patients with acromegaly inadequately controlled with the first-generation somatostatin analogue octreotide LAR. clinicaltrials.gov, NCT00600886 . Registered 14 January 2008.

Risk of stroke in patients with patent foramen ovale: an updated meta-analysis of observational studies.

PubMed

Ma, Bing; Liu, Guangcong; Chen, Xin; Zhang, Jianming; Liu, Yiting; Shi, Jingpu

2014-01-01

Although patent foramen ovale (PFO) is considered to be associated with cryptogenic stroke (CS), there remains an ongoing disputation on this issue because of unstable results from randomized controlled trials. The aim of this study was to reassess the PFO effect on stroke through observational data. An electronic search of PubMed, Web of Science, and China National Knowledge Infrastructure (CNKI) were finished. Only case-control studies and cohort studies in Chinese or English were included in the analysis. Then random-effected meta-analysis models were performed to assess the association between PFO and stroke. Twelve case-control studies and 6 cohort studies were eligible. Case-control studies showed strong association between PFO and CS (odds ratio [OR]: 2.94, 95% confidence interval [CI]: 2.06, 4.20; P < .001), but cohort studies failed to demonstrate a significant association (hazard ratio [HR]: 1.28, 95% CI: .91, 1.80; P = .155). Subgroup analysis revealed that the pooled OR decreased significantly when the region was limited to the United States (OR: 1.52, 95% CI: 1.00, 2.32; P = .083). OR of studies that adjusted major confounders was 1.74 (95% CI: 1.22, 2.47; P = .119) and high-quality studies was 1.68 (95% CI: 1.14, 2.47; P = .072). For cohort studies, a weak statistical association was observed in using transesophageal echocardiography (TEE) studies (HR: 1.45, 95% CI: 1.06, 2.01; P = .138) and follow-up years less than 4 years' studies (HR: 1.45, 95% CI: 1.00, 2.09; P = .064). Although case-control studies still show a positive effect of PFO on stroke, the results of cohort challenged the credibility. Further trial data are needed to confirm the effect of PFO on stroke. Copyright © 2014 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Twelve month follow-up on a randomised controlled trial of relaxation training for post-stroke anxiety.

PubMed

Golding, Katherine; Fife-Schaw, Chris; Kneebone, Ian

2017-09-01

To follow up participants in a randomised controlled trial of relaxation training for anxiety after stroke at 12 months. Twelve month follow-up to a randomised controlled trial, in which the control group also received treatment. Community. Fifteen of twenty one original participants with post-stroke anxiety participated in a one year follow-up study. A self-help autogenic relaxation CD listened to five times a week for one month, immediately in the intervention group and after three months in the control group. Hospital Anxiety and Depression Scale-Anxiety subscale and the Telephone Interview of Cognitive Status for inclusion. Hospital Anxiety and Depression Scale-Anxiety subscale for outcome. All measures were administered by phone. Anxiety ratings reduced significantly between pre and post-intervention, and between pre-intervention and one year follow-up ( χ 2 (2) = 22.29, p < 0.001). Reductions in anxiety in stroke survivors who received a self-help autogenic relaxation CD appear to be maintained after one year.

Determination of the effects of playing soccer on physical fitness in individuals with transtibial amputation.

PubMed

Guchan, Zehra; Bayramlar, Kezban; Ergun, Nevin

2017-06-01

The aim of this paper is to determine the effects of playing soccer on various components of physical performance such as body composition, muscular endurance, anaerobic power, flexibility, balance, and speed of individuals with transtibial amputation. Twelve amputee football players aged 26.67±7.76 years and twelve sedentary individuals aged 33±6.7 years were involved in this study. Body composition, and isotonic and isometric endurance of trunk muscles were assessed. Vertical jump test, sit-and-reach test, modified Thomas test, Berg Balance Scale, L test, and figure-of-eight walk (F8W) test were used to assess other physical fitness parameters. The Body Mass Index, waist circumference and body fat percentages of the amputee soccer players were significantly lower than the sedentary amputees (P<0.05). The endurance of back extensors was significantly higher in the soccer group (119.33±47.15 s) than the endurance in the control group (26.25±15.96 s) (P<0.001). Subjects belonging to the soccer group had significantly higher anaerobic power than those in the control group (P<0.05). Flexibility, as assessed by the sit-and-reach test was significantly higher for the soccer group (P=0.002), whereas the modified Thomas test, which is also used to measure flexibility, indicated no significant difference among both groups (P>0.05). Balance was higher in the soccer group (P=0.023). The completion period of the F8W test was significantly lower in the soccer group (4.54±0.9 s) than in the control group (7.71±2.25 s) (P<0.001). No significant difference was observed in the numbers of steps measured during the F8W test (P=0.231). This is the first study which investigates the effects of sports on the physical fitness of individuals with transtibial amputation with the inclusion of a control group. Overall findings present the benefits of participating in playing soccer on physical fitness parameters of amputees, but further studies with randomized controlled trials, with larger populations, and with other sport branches should be conducted to motivate all amputees to participate in sports.

Accelerated rehabilitation compared with a standard protocol after distal radial fractures treated with volar open reduction and internal fixation: a prospective, randomized, controlled study.

PubMed

Brehmer, Jess L; Husband, Jeffrey B

2014-10-01

There are relatively few studies in the literature that specifically evaluate accelerated rehabilitation protocols for distal radial fractures treated with open reduction and internal fixation (ORIF). The purpose of this study was to compare the early postoperative outcomes (at zero to twelve weeks postoperatively) of patients enrolled in an accelerated rehabilitation protocol with those of patients enrolled in a standard rehabilitation protocol following ORIF for a distal radial fracture. We hypothesized that patients with accelerated rehabilitation after volar ORIF for a distal radial fracture would have an earlier return to function compared with patients who followed a standard protocol. From November 2007 to November 2010, eighty-one patients with an unstable distal radial fracture were prospectively randomized to follow either an accelerated or a standard rehabilitation protocol after undergoing ORIF with a volar plate for a distal radial fracture. Both groups began with gentle active range of motion at three to five days postoperatively. At two weeks, the accelerated group initiated wrist/forearm passive range of motion and strengthening exercises, whereas the standard group initiated passive range of motion and strengthening at six weeks postoperatively. Patients were assessed at three to five days, two weeks, three weeks, four weeks, six weeks, eight weeks, twelve weeks, and six months postoperatively. Outcomes included Disabilities of the Arm, Shoulder and Hand (DASH) scores (primary outcome) and measurements of wrist flexion/extension, supination, pronation, grip strength, and palmar pinch. The patients in the accelerated group had better mobility, strength, and DASH scores at the early postoperative time points (zero to eight weeks postoperatively) compared with the patients in the standard rehabilitation group. The difference between the groups was both clinically relevant and statistically significant. Patients who follow an accelerated rehabilitation protocol that emphasizes motion immediately postoperatively and initiates strengthening at two weeks after volar ORIF of a distal radial fracture have an earlier return to function than patients who follow a more standard rehabilitation protocol. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. Copyright © 2014 by The Journal of Bone and Joint Surgery, Incorporated.

Comparison of patient comprehension of rapid HIV pre-test fundamentals by information delivery format in an emergency department setting

PubMed Central

Merchant, Roland C; Gee, Erin M; Clark, Melissa A; Mayer, Kenneth H; Seage, George R; DeGruttola, Victor G

2007-01-01

Background Two trials were conducted to compare emergency department patient comprehension of rapid HIV pre-test information using different methods to deliver this information. Methods Patients were enrolled for these two trials at a US emergency department between February 2005 and January 2006. In Trial One, patients were randomized to a no pre-test information or an in-person discussion arm. In Trial Two, a separate group of patients were randomized to an in-person discussion arm or a Tablet PC-based video arm. The video, "Do you know about rapid HIV testing?", and the in-person discussion contained identical Centers for Disease Control and Prevention-suggested pre-test information components as well as information on rapid HIV testing with OraQuick®. Participants were compared by information arm on their comprehension of the pre-test information by their score on a 26-item questionnaire using the Wilcoxon rank-sum test. Results In Trial One, 38 patients completed the no-information arm and 31 completed the in-person discussion arm. Of these 69 patients, 63.8% had twelve years or fewer of formal education and 66.7% had previously been tested for HIV. The mean score on the questionnaire for the in-person discussion arm was higher than for the no information arm (18.7 vs. 13.3, p ≤ 0.0001). In Trial Two, 59 patients completed the in-person discussion and 55 completed the video arms. Of these 114 patients, 50.9% had twelve years or fewer of formal education and 68.4% had previously been tested for HIV. The mean score on the questionnaire for the video arm was similar to the in-person discussion arm (20.0 vs. 19.2; p ≤ 0.33). Conclusion The video "Do you know about rapid HIV testing?" appears to be an acceptable substitute for an in-person pre-test discussion on rapid HIV testing with OraQuick®. In terms of adequately informing ED patients about rapid HIV testing, either form of pre-test information is preferable than for patients to receive no pre-test information. PMID:17850670

Positive Education for Young Children: Effects of a Positive Psychology Intervention for Preschool Children on Subjective Well Being and Learning Behaviors

PubMed Central

Shoshani, Anat; Slone, Michelle

2017-01-01

Despite the flourishing in recent years in applications of positive psychology in the field of education, there is a paucity of research investigating positive psychology interventions for preschool children. The present study examined the effects of a positive psychology-based intervention conducted in Israel on children’s subjective well-being, mental health and learning behaviors. Twelve preschool classrooms of 3–6.5 year-olds were randomly assigned to a positive psychology intervention condition or a wait-list control condition. In the intervention condition, during one school year, 160 children experienced eight modules of basic concepts in positive psychology that were adapted to the developmental characteristics of young children and were compared to 155 children in demographically similar control classrooms. Children were administered a pre-test and post-test of subjective well-being measures. In addition, children’s mental health and emotional well-being were measured by parental questionnaires. Preschool teachers completed questionnaires concerning children’s learning behaviors. The findings showed significant increases in subjective well-being and positive learning behaviors among the intervention participants, with no significant changes in the control group. The results highlight the potential of positive psychology interventions for increasing subjective well-being and a positive approach to learning at young ages. PMID:29123496

Selective Estrogen Receptor Modulation Increases Hippocampal Activity during Probabilistic Association Learning in Schizophrenia

PubMed Central

Kindler, Jochen; Weickert, Cynthia Shannon; Skilleter, Ashley J; Catts, Stanley V; Lenroot, Rhoshel; Weickert, Thomas W

2015-01-01

People with schizophrenia show probabilistic association learning impairment in conjunction with abnormal neural activity. The selective estrogen receptor modulator (SERM) raloxifene preserves neural activity during memory in healthy older men and improves memory in schizophrenia. Here, we tested the extent to which raloxifene modifies neural activity during learning in schizophrenia. Nineteen people with schizophrenia participated in a twelve-week randomized, double-blind, placebo-controlled, cross-over adjunctive treatment trial of the SERM raloxifene administered orally at 120 mg daily to assess brain activity during probabilistic association learning using functional magnetic resonance imaging (fMRI). Raloxifene improved probabilistic association learning and significantly increased fMRI BOLD activity in the hippocampus and parahippocampal gyrus relative to placebo. A separate region of interest confirmatory analysis in 21 patients vs 36 healthy controls showed a positive association between parahippocampal neural activity and learning in patients, but no such relationship in the parahippocampal gyrus of healthy controls. Thus, selective estrogen receptor modulation by raloxifene concurrently increases activity in the parahippocampal gyrus and improves probabilistic association learning in schizophrenia. These results support a role for estrogen receptor modulation of mesial temporal lobe neural activity in the remediation of learning disabilities in both men and women with schizophrenia. PMID:25829142

Managing post-therapy fatigue for cancer survivors using energy conservation training.

PubMed

Yuen, Hon Keung; Mitcham, Maralynne; Morgan, Larissa

2006-01-01

This pilot study evaluated the effectiveness of energy conservation training to help post-therapy cancer survivors manage their fatigue. Twelve post-therapy cancer survivors were randomly assigned to an energy conservation training or usual care control (6 in each group). Participants in the intervention group received 1 to 2 hours of individual, face-to-face energy conservation training from an occupational therapist followed by once-a-week telephone monitoring sessions in the subsequent three weeks. Participants in the control group received standard care from their oncologist. Analysis of pre- and post-training data from the Piper Fatigue Scale (PFS) revealed significant reduction only in the sensory subscale of the PFS (Z = 2.21; p = 0.027) for the intervention group; but no significant reduction in the four subscale or total scores of the PFS for the control group. Findings demonstrate partial support for the effectiveness of energy conservation training in helping post-therapy cancer survivors manage their fatigue. Energy conservation training seems to be a viable strategy for managing cancer-related fatigue, though its efficacy is modest. Incorporating specific energy restoration strategies such as relaxation and meditation for future research may help advance the growing body of knowledge in symptom management for post-therapy cancer survivors.

Positive Education for Young Children: Effects of a Positive Psychology Intervention for Preschool Children on Subjective Well Being and Learning Behaviors.

PubMed

Shoshani, Anat; Slone, Michelle

2017-01-01

Despite the flourishing in recent years in applications of positive psychology in the field of education, there is a paucity of research investigating positive psychology interventions for preschool children. The present study examined the effects of a positive psychology-based intervention conducted in Israel on children's subjective well-being, mental health and learning behaviors. Twelve preschool classrooms of 3-6.5 year-olds were randomly assigned to a positive psychology intervention condition or a wait-list control condition. In the intervention condition, during one school year, 160 children experienced eight modules of basic concepts in positive psychology that were adapted to the developmental characteristics of young children and were compared to 155 children in demographically similar control classrooms. Children were administered a pre-test and post-test of subjective well-being measures. In addition, children's mental health and emotional well-being were measured by parental questionnaires. Preschool teachers completed questionnaires concerning children's learning behaviors. The findings showed significant increases in subjective well-being and positive learning behaviors among the intervention participants, with no significant changes in the control group. The results highlight the potential of positive psychology interventions for increasing subjective well-being and a positive approach to learning at young ages.

Effect of Anatomical Customization of the Fiber Post on the Bond Strength of a Self-Adhesive Resin Cement.

PubMed

Rocha, Adricyla Teixeira; Gonçalves, Leticia Machado; Vasconcelos, Ana Júlia de Carvalho; Matos Maia Filho, Etevaldo; Nunes Carvalho, Ceci; De Jesus Tavarez, Rudys Rodolfo

2017-01-01

The aim of the study was to evaluate, by means of the push-out test, the effect of the anatomical customization of the fiber post on the bond strength of a self-adhesive resin cement. Twelve endodontically treated, human, upper central incisors were randomly divided into two groups ( n = 6): control (glass fiber posts cemented with Relyx® U200) and customized (glass fiber posts anatomically customized with translucent composite resin cemented with Relyx U200). The roots were sectioned into three slices, cervical, middle, and apical, and photographed with a digital camera attached to a stereomicroscopic loupe. The images were analyzed by software, for evaluation of the cement line. The slices were subsequently submitted to the push-out test until the post had completely extruded, and the fracture mode was analyzed with a stereomicroscopic loupe. The results showed significant differences between the groups in the different root thirds in relation to the area occupied by air bubbles ( p < 0.05). Bond strength, when all the thirds are considered, was 8.77 ± 4.89 MPa for the control group and 16.96 ± 4.85 MPa for the customized group. The customized group showed greater bond resistance than the control group and a more uniform cement layer.

Clinical evaluation of selected Yogic procedures in individuals with low back pain

PubMed Central

Pushpika Attanayake, A. M.; Somarathna, K. I. W. K.; Vyas, G. H.; Dash, S. C.

2010-01-01

The present study has been conducted to evaluate selected yogic procedures on individuals with low back pain. The understanding of back pain as one of the commonest clinical presentations during clinical practice made the path to the present study. It has also been calculated that more than three-quarters of the world's population experience back pain at some time in their lives. Twelve patients were selected and randomly divided into two groups, viz., group A yogic group and group B control group. Advice for life style and diet was given for all the patients. The effect of the therapy was assessed subjectively and objectively. Particular scores drawn for yogic group and control group were individually analyzed before and after treatment and the values were compared using standard statistical protocols. Yogic intervention revealed 79% relief in both subjective and objective parameters (i.e., 7 out of 14 parameters showed statistically highly significant P < 0.01 results, while 4 showed significant results P < 0.05). Comparative effect of yogic group and control group showed 79% relief in both subjective and objective parameters. (i.e., total 6 out of 14 parameters showed statistically highly significant (P < 0.01) results, while 5 showed significant results (P < 0.05). PMID:22131719

Characterization of Friction Joints Subjected to High Levels of Random Vibration

NASA Technical Reports Server (NTRS)

deSantos, Omar; MacNeal, Paul

2012-01-01

This paper describes the test program in detail including test sample description, test procedures, and vibration test results of multiple test samples. The material pairs used in the experiment were Aluminum-Aluminum, Aluminum- Dicronite coated Aluminum, and Aluminum-Plasmadize coated Aluminum. Levels of vibration for each set of twelve samples of each material pairing were gradually increased until all samples experienced substantial displacement. Data was collected on 1) acceleration in all three axes, 2) relative static displacement between vibration runs utilizing photogrammetry techniques, and 3) surface galling and contaminant generation. This data was used to estimate the values of static friction during random vibratory motion when "stick-slip" occurs and compare these to static friction coefficients measured before and after vibration testing.

[Cost-effectiveness of study nurses in the management of patients with heart failure. A systematic review].

PubMed

Biermann, J; Mostardt, S; Neumann, T; Erbel, R; Wasem, J; Neumann, A

2010-06-01

Heart failure is currently one of the most common and cost-intensive diseases. Furthermore, high morbidity and mortality are distinctive for this disease. Therefore, new treatment programs are increasingly developed; especially the care of heart failure patients by specialized nurses (study nurses) represents a frequent new concept. This review gives a systematic overview of the cost-effectiveness of new treatment concepts with study nurses in comparison to the conventional care of heart failure. A systematic literature search in MEDLINE was performed for the period from 1995 till April 2008. The search strategy included terms from three essential areas relating to the working subject: twelve search keys with regard to the clinical picture, 21 words concerning the intervention with study nurses, and 27 terms with reference to health economics. The literature selection was carried out on the basis of a priori defined in- and exclusion criteria. Economic evaluations based on randomized controlled trials with a study duration of at least 6 months which were published in English or German were enclosed. An extraction of the relevant data as well as a qualitative synthesis of information were conducted. A total of 13 studies were identified. With five of nine of the enclosed publications, a statistically significant reduction of the number of all-cause rehospitalizations was reported. Two of twelve publications showed a statistically significant decrease in mortality in favor of the intervention group. Twelve of 13 publications only reported the costs and effects of both groups separately. For the five of nine publications with significant reductions of rehospitalization, an own calculation of the incremental cost-effectiveness ratio (ICER) could be carried out based on the cost and effect data. It turned out an ICER of costs at the rate of 490 Euros up to savings of 7,330 Euros per prevented rehospitalization. This systematic review shows an international trend that concepts for the care of patients with heart failure that involve study nurses are cost-effective. For the German context there are no comparable data available.

Efficiency of erosion control practices of the Virginia Department of Highways and Transportation : final report.

DOT National Transportation Integrated Search

1982-01-01

Twelve streams affected by highway construction were monitored to ascertain the effectiveness of the Virginia Department of Highways and Transportation's erosion and sediment control practices. The streams were located throughout Virginia in areas ha...

Improving oral hygiene in the long-term care of the elderly--a RCT.

PubMed

Zenthöfer, Andreas; Dieke, Reinhard; Dieke, Anke; Wege, Karl-Christian; Rammelsberg, Peter; Hassel, Alexander J

2013-06-01

Oral hygiene and health of the institutionalized elderly are frequently described as inadequate. This randomized and single-blinded (outcome evaluation) study compared three types of intervention for improving oral hygiene with a control. The purpose was to investigate whether there were any significant differences between the intervention and control groups. One hundred and six participants living in long-term care homes in South-West Germany were recruited and randomly divided into four groups-three therapy groups and one control group. For all three therapy groups, teeth and dentures were cleaned professionally and individual instruction was given. One of these groups was also re-instructed and remotivated by a dentist (n = 27). One also received help from, and was remotivation by, staff educated in dental hygiene (n = 26). The third therapy group was not remotivated after professional cleaning of teeth and dentures (n = 26). For the control group, there was no intervention (n = 23). The main target clinical data were mean plaque (plaque-control record, O'Leary), gingival bleeding (Ainamo/Bay), and denture hygiene indices. For assessment of the difference between being in an intervention group and in a control group, mixed-model analysis for repeated measurements was performed for each main target variable. In addition, target clinical data were evaluated in long-term follow-up after 3 years. Compared with controls, denture hygiene, plaque, and gingival bleeding indices were significantly lower in the intervention groups over a twelve-week period (mixed model for repeated measurements; P < 0.023). Estimates of effects between control and each treatment group were comparable among the three therapy groups; however, even though two of the groups received further help and instruction. Long-term follow-up showed that all indices were significantly worse than at the last study recall (P < 0.001). Professional cleaning of teeth and dentures, with individual instruction, can be recommended to improve oral hygiene. However, the effect decreases over time and renewal of the intervention is necessary. © 2012 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The immediate effect of neuromuscular joint facilitation on the rotation of the tibia during walking.

PubMed

Li, Desheng; Huang, Qiuchen; Huo, Ming; Hiiragi, Yukinobu; Maruyama, Hitoshi

2017-01-01

[Purpose] The aim of this study was to investigate the change in tibial rotation during walking among young adults after neuromuscular joint facilitation therapy. [Subjects and Methods] The subjects were twelve healthy young people (6 males, 6 females). A neuromuscular joint facilitation intervention and nonintervention were performed. The interventions were performed one after the other, separated by a 1-week interval. The order of the interventions was completely randomized. The rotation of the tibia during walking was evaluated before and after treatment. [Results] The neuromuscular joint facilitation group demonstrated increased lateral rotation of the tibia in the overall gait cycle and stance phase, and decreased medial rotation of the tibia in the overall gait cycle, stance phase, and swing phase after the neuromuscular joint facilitation intervention. In the control group, there were no significant differences. [Conclusion] These results suggest neuromuscular joint facilitation intervention has an immediate effect on the rotational function of the knee.

Perioperative single high dose ATG-Fresenius S administration as induction immunosuppressive therapy in cadaveric renal transplantation--preliminary results.

PubMed

Samsel, R; Chmura, A; Włodarczyk, Z; Wyzgał, J; Cieciura, T; Lagiewska, B; Pliszczyński, J; Korczak, G; Lazowski, T; Paczek, L; Wałaszewski, J; Lao, M; Rowiński, W

1999-01-01

Monoclonal and polyclonal antilymphocyte antibodies have been used successfully in organ transplantation as induction therapy and in the treatment of acute graft rejection. Used for induction the medication is generally given for the first 7-10 days. The aim of this study was to assess the safety and efficacy of single high dose (9 mg/kg) ATG Fresenius S given perioperatively, before revascularization, to kidney allograft recipients. During last twelve months seventy six, first cadaveric kidney adult recipients were included into the study in two centers (center A-64, center B-12). All patients received triple drug immunosuppression (Neoral, steroids and Cellcept which was replaced by azathioprine after 4 months), and were randomized to receive ATG or not. The follow-up period ranged from 1 month up to 1 year. The preliminary results are very promising, the rejection rate in bolus group was significantly lower than in control. No significant side effects or serious adverse events in both groups were observed.

Short-term anomia training and electrical brain stimulation.

PubMed

Flöel, Agnes; Meinzer, Marcus; Kirstein, Robert; Nijhof, Sarah; Deppe, Michael; Knecht, Stefan; Breitenstein, Caterina

2011-07-01

Language training success in chronic aphasia remains only moderate. Electric brain stimulation may be a viable way to enhance treatment efficacy. In a randomized, double-blind, sham-controlled crossover trial, we assessed if anodal transcranial direct current stimulation compared to cathodal transcranial direct current stimulation and sham stimulation over the right temporo-parietal cortex would improve the success of short-term high-frequency anomia training. Twelve chronic poststroke aphasia patients were studied. Naming outcome was assessed after training and 2 weeks later. All training conditions led to a significant increase in naming ability, which was retained for at least 2 weeks after the end of the training. Application of anodal transcranial direct current stimulation significantly enhanced the overall training effect compared to sham stimulation. Baseline naming ability significantly predicted anodal transcranial direct current stimulation effects. Anodal transcranial direct current stimulation applied over the nonlanguage dominant hemisphere can enhance language training outcome in chronic aphasia. Clinical Trial Registration- URL: www.clinicaltrials.gov/. Unique identifier: NCT00822068.

The use of autologous platelet-rich plasma in the orthopedic setting.

PubMed

Cohn, Claudia S; Lockhart, Evelyn; McCullough, J Jeffrey

2015-07-01

Autologous platelet-rich plasma (aPRP) is widely used with orthopedic patients to help treat injuries to tendons, cartilage, ligaments, and muscle. A comprehensive review of the literature was conducted to evaluate aPRP's efficacy and compare available methods. In addition, the production and administration of aPRP were explored. A literature search was performed. Randomized controlled clinical trials (RCTs) in orthopedic procedures on adult patients were included and assessed for methodologic quality. The main outcomes were pain relief, increase in function, structural integrity, and "healing" based on various validated scales. Twelve RCTs and one controlled cohort were included (four lateral epicondylitis, two chronic Achilles tendinopathy, two anterior cruciate ligament injury, and five rotator cuff injuries). Four trials reported some benefit from aPRP versus controls while eight trials found no benefit from aPRP applications versus control. One study had too many patients withdraw from the control arm for acceptable data interpretation. All protocols used a different aPRP formulation or method of delivery or application. Despite its popularity, there are no standardized criteria that define aPRP. Different techniques yield wide variability in terms of platelet count and concentration. These variations make it difficult to compare clinical trials that use aPRP or draw conclusions concerning its clinical efficacy in orthopedic procedures. Blood bankers have experience in the production of standardized blood components. This expertise may be used to develop and implement protocols for the production and administration of aPRP, as well as quality control measures. © 2015 AABB.

Decreasing Internal Focus of Attention Improves Postural Control during Quiet Standing in Young Healthy Adults

ERIC Educational Resources Information Center

Nafati, Gilel; Vuillerme, Nicolas

2011-01-01

This experiment was designed to investigate whether and how decreasing the amount of attentional focus invested in postural control could affect bipedal postural control. Twelve participants were asked to stand upright as immobile as possible on a force platform in one control condition and one cognitive condition. In the latter condition, they…

Early physiotherapy ad modum Vojta or Bobath in infants with suspected neuromotor disturbance.

PubMed

d'Avignon, M; Norén, L; Arman, T

1981-08-01

Thirty children with early signs of cerebral neuromotor disturbances according to "Vojta criteria" were followed until the age of thirty-three months to six years. Twelve children were treated with early physiotherapy according to Bobath, ten children were treated according to Vojta and eight constituted a control group. The infants tended for early physical therapy were divided by random into two different groups. The neonatal risk factors, however, proved to be unevenly distributed among the infants in the Vojta- and the Bobath-treated groups - the latter being more heavily burdened in this respect. Vojta has claimed that his method of early physiotherapy is able to prevent the development of cerebral palsy (cp) of "uncomplicated" (but not of "complicated") type. At follow-up we found one child out of nine with "uncomplicated" cp in the Vojta group against three out of six in the Bobath- and two out of six in the control group. These differences, however, are not statistically significant. Further detailed studies with greater groups of children seem necessary to help us to clarify these problems. The psychological aspects of early physiotherapy should be thoroughly considered and this is particularly important in connection with the Vojta method.

Workplace physical activity interventions: a systematic review.

PubMed

To, Quyen G; Chen, Ted T L; Magnussen, Costan G; To, Kien G

2013-01-01

To assess the effectiveness of workplace interventions in improving physical activity. EBSCO research database (and all subdatabases). Articles were published from 2000 to 2010 in English, had appropriate designs, and measured employees' physical activity, energy consumption, and/or body mass index (BMI) as primary outcomes. Articles that did not meet the inclusion criteria were excluded. Data extracted included study design, study population, duration, intervention activities, outcomes, and results. Data were synthesized into one table. Results of each relevant outcome including p values were combined. Twelve (60%) of 20 selected interventions reported an improvement in physical activity level, steps, or BMI, and there was one slowed step reduction in the intervention group. Among these, 10 were less than 6 months in duration; 9 used pedometers; 6 applied Internet-based approaches; and 5 included activities targeting social and environmental levels. Seven of 8 interventions with pre-posttest and quasi-experimental controlled design showed improvement on at least one outcome. However, 7 of 12 randomized controlled trials (RCTs) did not prove effective in any outcome. Interventions that had less rigorous research designs, used pedometers, applied Internet-based approaches, and included activities at social and environmental levels were more likely to report being effective than those without these characteristics.

Production of isometric forces during sustained acceleration.

PubMed

Sand, D P; Girgenrath, M; Bock, O; Pongratz, H

2003-06-01

The operation of high-performance aircraft requires pilots to apply finely graded forces on controls. Since they are often exposed to high levels of acceleration in flight, we investigated to what extent this ability is degraded in such an environment. Twelve healthy non-pilot volunteers were seated in the gondola of a centrifuge and their performance was tested at normal gravity (1 G) and while exposed to sustained forces of 1.5 G and 3 G oriented from head to foot (+Gz). Using an isometric joystick, they attempted to produce force vectors with specific lengths and directions commanded in random order by a visual display. Acceleration had substantial effects on the magnitude of produced force. Compared with 1 G, maximum produced force was about 2 N higher at 1.5 G and about 10 N higher at 3 G. The size of this effect was constant across the different magnitudes, but varied with the direction of the prescribed force. Acceleration degrades control of force production. This finding may indicate that the motor system misinterprets the unusual gravitoinertial environment and/or that proprioceptive feedback is degraded due to increased muscle tone. The production of excessive isometric force could affect the safe operation of high-performance aircraft.

Alcohol and aggressive behavior in men--moderating effects of oxytocin receptor gene (OXTR) polymorphisms.

PubMed

Johansson, A; Bergman, H; Corander, J; Waldman, I D; Karrani, N; Salo, B; Jern, P; Algars, M; Sandnabba, K; Santtila, P; Westberg, L

2012-03-01

We explored if the disposition to react with aggression while alcohol intoxicated was moderated by polymorphic variants of the oxytocin receptor gene (OXTR). Twelve OXTR polymorphisms were genotyped in 116 Finnish men [aged 18-30, M = 22.7, standard deviation (SD) = 2.4] who were randomly assigned to an alcohol condition in which they received an alcohol dose of 0.7 g pure ethanol/kg body weight or a placebo condition. Aggressive behavior was measured using a laboratory paradigm in which it was operationalized as the level of aversive noise administered to a fictive opponent. No main effects of the polymorphisms on aggressive behavior were found after controlling for multiple testing. The interactive effects between alcohol and two of the OXTR polymorphisms (rs4564970 and rs1488467) on aggressive behavior were nominally significant and remained significant for the rs4564970 when controlled for multiple tests. To the best of our knowledge, this is the first experimental study suggesting interactive effects of specific genetic variants and alcohol on aggressive behavior in humans. © 2011 The Authors. Genes, Brain and Behavior © 2011 Blackwell Publishing Ltd and International Behavioural and Neural Genetics Society.

EMG and Kinematic Responses to Unexpected Slips After Slip Training in Virtual Reality

PubMed Central

Parijat, Prakriti; Lockhart, Thurmon E.

2015-01-01

The objective of the study was to design a virtual reality (VR) training to induce perturbation in older adults similar to a slip and examine the effect of the training on kinematic and muscular responses in older adults. Twenty-four older adults were involved in a laboratory study and randomly assigned to two groups (virtual reality training and control). Both groups went through three sessions including baseline slip, training, and transfer of training on slippery surface. The training group experienced twelve simulated slips using a visual perturbation induced by tilting a virtual reality scene while walking on the treadmill and the control group completed normal walking during the training session. Kinematic, kinetic, and EMG data were collected during all the sessions. Results demonstrated the proactive adjustments such as increased trunk flexion at heel contact after training. Reactive adjustments included reduced time to peak activations of knee flexors, reduced knee coactivation, reduced time to trunk flexion, and reduced trunk angular velocity after training. In conclusion, the study findings indicate that the VR training was able to generate a perturbation in older adults that evoked recovery reactions and such motor skill can be transferred to the actual slip trials. PMID:25296401

The Antimicrobial Photodynamic Therapy in the Treatment of Peri-Implantitis

PubMed Central

Libotte, Fabrizio; Sabatini, Silvia; Grassi, Felice Roberto

2016-01-01

Introduction. The aim of this study is to demonstrate the effectiveness of addition of the antimicrobial photodynamic therapy to the conventional approach in the treatment of peri-implantitis. Materials and Methods. Forty patients were randomly assigned to test or control groups. Patients were assessed at baseline and at six (T1), twelve (T2), and twenty-four (T3) weeks recording plaque index (PlI), probing pocket depth (PPD), and bleeding on probing (BOP); control group received conventional periodontal therapy, while test group received photodynamic therapy in addition to it. Result. Test group showed a 70% reduction in the plaque index values and a 60% reduction in PD values compared to the baseline. BOP and suppuration were not detectable. Control group showed a significative reduction in plaque index and PD. Discussion. Laser therapy has some advantages in comparison to traditional therapy, with faster and greater healing of the wound. Conclusion. Test group showed after 24 weeks a better value in terms of PPD, BOP, and PlI, with an average pocket depth value of 2 mm, if compared with control group (3 mm). Our results suggest that antimicrobial photodynamic therapy with diode laser and phenothiazine chloride represents a reliable adjunctive treatment to conventional therapy. Photodynamic therapy should, however, be considered a coadjuvant in the treatment of peri-implantitis associated with mechanical (scaling) and surgical (grafts) treatments. PMID:27429618

Multi-modal Aedes aegypti mosquito reduction interventions and dengue fever prevention.

PubMed

Ballenger-Browning, Kara K; Elder, John P

2009-12-01

To systematically review the effectiveness of biological, chemical and educational dengue fever prevention programs on the reduction of entomologic indicators. Searches of PubMed, GoogleScholar, CabDirect databases and reference lists yielded over 1000 articles containing mosquito abatement interventions. Inclusion criteria were: Vector control programs targeting Aedes aegypti and Aedes albopictus mosquitoes; Studies providing pre- and post-test data. Intervention effectiveness was assessed using Mulla's formula to determine percent reductions for all studies with control groups. Twenty-one studies were reviewed. Twelve dependent variables were presented, however, the Breteau, House and Container indices were the primary measurement tools for monitoring larval populations. Behavioural methods consisting of educational campaigns and maintaining water containers to reduce the mosquito population were applied in eight studies. Eight studies involved the use of biological methods such as predatory organisms or bacteria. Finally, eight studies used chemical control techniques including insecticide sprays, larvicides, insecticide-treated materials, and cleaning water of containers with household chemicals with three studies using a combination of intervention techniques. Post-intervention reduction in entomologic indices ranged from 100% to an increase of 13.9% from baseline. Little evidence exists to support the efficacy of mosquito abatement programs owing to poor study designs and lack of congruent entomologic indices. Creation of a standard entomological index, use of clustered and randomized-controlled trials, and testing the generalizability of proven methods are recommended for future research.

Effects of Ving Tsun Chinese martial art training on musculoskeletal health, balance performance, and self-efficacy in community-dwelling older adults.

PubMed

Lip, Ryan W T; Fong, Shirley S M; Ng, Shamay S M; Liu, Karen P Y; Guo, X

2015-03-01

[Purpose] The aim of this study was to investigate the effects of Ving Tsun (VT) Chinese martial art training on radial bone strength, upper- and lower-limb muscular strength, shoulder joint mobility, balance performance, and self-efficacy in elderly participants. [Subjects and Methods] Twelve seniors voluntarily joined the VT training group, and twenty-seven seniors voluntarily joined the control group. The VT group received VT training for three months, while the control group received no training. The bone strength of the distal radius was assessed using an ultrasound bone sonometer. Muscular strength in the limbs was evaluated using a Jamar handgrip dynamometer and the five times sit-to-stand test. Shoulder joint mobility was examined using a goniometer. Balance performance and self-efficacy were evaluated using the Berg Balance Scale and the Chinese version of the Activities-specific Balance Confidence Scale, respectively. [Results] The results revealed a nonsignificant group-by-time interaction effect, group effect, and time effect for all outcome variables. However, general trends of maintenance or improvement in all outcome parameters were observed to a greater extent in the VT group than in the control group. [Conclusion] VT training might be a potential fall-prevention exercise that can be used to maintain general physique, balance, and confidence in the elderly population. A further randomized controlled trial is needed to confirm this postulation.

Effects of Ving Tsun Chinese martial art training on musculoskeletal health, balance performance, and self-efficacy in community-dwelling older adults

PubMed Central

Lip, Ryan W.T.; Fong, Shirley S.M.; Ng, Shamay S.M.; Liu, Karen P.Y.; Guo, X.

2015-01-01

[Purpose] The aim of this study was to investigate the effects of Ving Tsun (VT) Chinese martial art training on radial bone strength, upper- and lower-limb muscular strength, shoulder joint mobility, balance performance, and self-efficacy in elderly participants. [Subjects and Methods] Twelve seniors voluntarily joined the VT training group, and twenty-seven seniors voluntarily joined the control group. The VT group received VT training for three months, while the control group received no training. The bone strength of the distal radius was assessed using an ultrasound bone sonometer. Muscular strength in the limbs was evaluated using a Jamar handgrip dynamometer and the five times sit-to-stand test. Shoulder joint mobility was examined using a goniometer. Balance performance and self-efficacy were evaluated using the Berg Balance Scale and the Chinese version of the Activities-specific Balance Confidence Scale, respectively. [Results] The results revealed a nonsignificant group-by-time interaction effect, group effect, and time effect for all outcome variables. However, general trends of maintenance or improvement in all outcome parameters were observed to a greater extent in the VT group than in the control group. [Conclusion] VT training might be a potential fall-prevention exercise that can be used to maintain general physique, balance, and confidence in the elderly population. A further randomized controlled trial is needed to confirm this postulation. PMID:25931704

Effects of Perturbation-Based Slip Training using a Virtual Reality Environment on Slip-induced Falls

PubMed Central

Parijat, Prakriti; Lockhart, Thurmon E.; Liu, Jian

2015-01-01

The purpose of the current study was to design and evaluate the effectiveness of virtual reality training in improving recovery reactions and reducing fall frequency in older adults. Twenty-four older adults were recruited and randomly assigned to two groups (virtual reality training and control). Both groups underwent three sessions including baseline slip, training and transfer of training on slippery surface. Both groups experienced two slips, one during baseline and the other during the transfer of training trial. The training group underwent twelve simulated slips using a visual perturbation induced by tilting a virtual reality scene while walking on the treadmill and the control group performed normal walking during the training session. Kinematic and kinetic data were collected during all the sessions. Results demonstrated a reduced incidence of falls in the training group during the transfer of training trial as compared to the control group. The training group was able to transfer reactive control strategies learned during training to the second slip trial. The reactive adjustments included reduced slip distance. Additionally, gait parameters reflective of gait instability (stride length, step width, variability in stride velocity) reduced after walking in the VR environment for 15–20 min. The results indicated a beneficial effect of the virtual reality training in reducing slip severity and recovery kinematics in healthy older adults. PMID:25245221

Meta-analyses on intra-aortic balloon pump in cardiogenic shock complicating acute myocardial infarction may provide biased results.

PubMed

Acconcia, M C; Caretta, Q; Romeo, F; Borzi, M; Perrone, M A; Sergi, D; Chiarotti, F; Calabrese, C M; Sili Scavalli, A; Gaudio, C

2018-04-01

Intra-aortic balloon pump (IABP) is the device most commonly investigated in patients with cardiogenic shock (CS) complicating acute myocardial infarction (AMI). Recently meta-analyses on this topic showed opposite results: some complied with the actual guideline recommendations, while others did not, due to the presence of bias. We investigated the reasons for the discrepancy among meta-analyses and strategies employed to avoid the potential source of bias. Scientific databases were searched for meta-analyses of IABP support in AMI complicated by CS. The presence of clinical diversity, methodological diversity and statistical heterogeneity were analyzed. When we found clinical or methodological diversity, we reanalyzed the data by comparing the patients selected for homogeneous groups. When the fixed effect model was employed despite the presence of statistical heterogeneity, the meta-analysis was repeated adopting the random effect model, with the same estimator used in the original meta-analysis. Twelve meta-analysis were selected. Six meta-analyses of randomized controlled trials (RCTs) were inconclusive because underpowered to detect the IABP effect. Five included RCTs and observational studies (Obs) and one only Obs. Some meta-analyses on RCTs and Obs had biased results due to presence of clinical and/or methodological diversity. The reanalysis of data reallocated for homogeneous groups was no more in contrast with guidelines recommendations. Meta-analyses performed without controlling for clinical and/or methodological diversity, represent a confounding message against a good clinical practice. The reanalysis of data demonstrates the validity of the current guidelines recommendations in addressing clinical decision making in providing IABP support in AMI complicated by CS.

The Effect of Endothelin Receptor Antagonists in Patients with Eisenmenger Syndrome: A Systematic Review.

PubMed

Elshafay, Abdelrahman; Truong, Duy Hieu; AboElnas, Mohamed M; Idrees, Hossam; Metwali, Hatem G; Vuong, Nguyen Lam; Saad, Omar Ahmed; Hirayama, Kenji; Huy, Nguyen Tien

2018-04-01

The efficacy of endothelin receptor antagonists (ERAs) in the management of Eisenmenger syndrome (ES) remains controversial. The aim of this study is to systemically review the safety and effects of ERAs in improving the quality of life and basic cardiac functions of these patients. Twelve databases were searched, including PubMed, Web of Science, Scopus, Virtual Health Library, World Health Organization (WHO) Global Health Library, Google Scholar, POPLINE, Systems for Information of Grey Literature in Europe, New York Academy of Medicine, ClinicalTrials.gov, metaRegister of Controlled Trials and the WHO International Clinical Trials Registry Platform, through August 2016. We included randomized clinical trials addressing the effect of ERAs on cardiac functions in patients with ES. The quality of studies was assessed using the Cochrane Collaboration tool. We included two trials represented by four papers, of which three papers reported the efficacy of bosentan against placebo and one paper reported the results of a combination of bosentan and sildenafil versus placebo and bosentan. One trial showed a significant effect of bosentan treatment over placebo on indexed pulmonary vascular resistance and mean pulmonary artery pressure, but a non-significant increase in 6-min walk distance and a non-significant effect on systemic pulse oximetry. The other trial reported the safe but non-significant effect of combination therapy of bosentan and sildenafil compared with bosentan and placebo. This study demonstrated safety and improved hemodynamic effects of bosentan in ES, with a controversial effect on exercise capacity. Further randomized controlled trials with longer follow-up duration are needed to confirm these results.

A Systematic Review of Randomized Controlled Trials Examining the Effectiveness of Saffron (Crocus sativus L.) on Psychological and Behavioral Outcomes

PubMed Central

Hausenblas, Heather Ann; Heekin, Kacey; Mutchie, Heather Lee; Anton, Stephen

2017-01-01

Introduction Throughout the past three decades, increased scientific attention has been given to examining saffron’s (Crocus sativus L.) use as a potential therapeutic or preventive agent for a number of health conditions, including cancer, cardiovascular disease, and depression. Saffron has been shown to improve numerous health-related physiological to psychological outcomes. The purpose of this systematic review is to examine and categorize the current state of scientific evidence from randomized controlled trials (RCTs) regarding the efficacy of saffron on psychological and behavioral outcomes. Methods Electronic and non-electronic systematic searches were conducted to identify all relevant human clinical research on saffron. The search strategy was extensive and was designed according to the “Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)”. Reference lists of articles that met the inclusion criteria were searched. Only English language studies were reviewed. Results Twelve studies met our inclusion criteria. These studies examined the effects of saffron on psychological/behavioral outcomes with respect to the following health conditions: major depressive disorder (n = 6), premenstrual syndrome (n = 1), sexual dysfunction and infertility (n = 4), and weight loss/snacking behaviors (n = 1). The data from these studies support the efficacy of saffron in improving: depressive symptoms, premenstrual symptoms, sexual function, and satiety. Conclusion Findings from initial clinical trials suggest that saffron can improve the symptoms and effects of depression, premenstrual syndrome, sexual dysfunction and infertility, and excessive snacking behaviors. Larger multi-site clinical trials are needed to extend these preliminary findings. PMID:26165367

Perturbation training can reduce community-dwelling older adults' annual fall risk: a randomized controlled trial.

PubMed

Pai, Yi-Chung; Bhatt, Tanvi; Yang, Feng; Wang, Edward

2014-12-01

Previous studies indicated that a single session of repeated-slip exposure can reduce over 40% of laboratory-induced falls among older adults. The purpose of this study was to determine to what degree such perturbation training translated to the reduction of older adults' annual falls risk in their everyday living. Two hundred and twelve community-dwelling older adults (≥65 years old) were randomly assigned to either the training group (N = 109), who then were exposed to 24 unannounced repeated slips, or the control group (N = 103), who merely experienced one slip during the same walking in the same protective laboratory environment. We recorded their falls in the preceding year (through self-reported history) and during the next 12 months (through falls diary and monitored with phone calls). With this single session of repeated-slip exposure, training cut older adults' annual risk of falls by 50% (from 34% to 15%, p < .05). Those who experienced merely a single slip were 2.3 times more likely to fall during the same 12-month follow-up period (p < .05) than those who experienced the 24 repeated slips. Such training effect was especially prominent among those who had history of falls. A single session of repeated-slip exposure could improve community-dwelling older adults' resilience to postural disturbances and, hence, significantly reduce their annual risk of falls. © The Author 2014. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Efficacy of memory training in healthy community-dwelling older people: study protocol for a randomized controlled trial.

PubMed

Pérez, Anna; Roqué, Marta; Domènech, Sara; Monteserín, Rosa; Soriano, Núria; Blancafort, Xavier; Bosom, Maria; Vidal, Cristina; Petit, Montse; Hortal, Núria; Gil, Carles; Espelt, Albert; López, Maria José

2015-10-01

There is limited evidence on the efficacy and social utility of cognitive training. To address this, we have designed a randomized controlled trial to assess the effectiveness of memory training workshops for healthy older people in terms of their short- and long-term impact on cognitive function, health-related quality of life, and functionality. A randomized controlled trial will be performed in health care centers in Barcelona (Spain) through comparison of a group of individuals participating in memory training workshops (experimental group) with another group with similar characteristics not participating in the workshops (control group). The intervention will consist of twelve 90-minute group sessions imparted once a week by a psychologist specialized in memory training. The groups will each comprise approximately 15 people, for a total number of 230 patients involved in the study. Each session has its own objectives, materials and activities. The content of the intervention is based on memory training from different perspectives, including cognitive and emotional aspects and social and individual skills. Data will be collected at baseline, at 3-4 months and at 6 months. To assess the efficacy of the intervention on cognitive function, health-related quality of life and functionality, a statistical analysis will be performed by fitting a repeated-measures mixed effects model for each main outcome: Self-perceived memory, measured by a Subjective Self-reported Memory Score (from 0 to 10) and by the Memory Failures in Everyday life questionnaire (MFE); Everyday memory, measured using the Rivermead Behavioural Memory Test-3 (RBMT-3) and Executive control abilities, measured in terms of visual-perceptual ability, working memory and task-switching ability with the Trail Making Test (TMT) and with the digit span scale of the Wechsler Adult Intelligence Scale III (WAIS III). The results of this study will be highly useful for social and public health policies related to older people. Given the continuous increase in the prevalence of older people, a large number of interventions targeting memory loss are funded by public resources. To ensure transparency and effective prioritization, research such as the present study is needed to provide evidence of the effectiveness and usefulness of these interventions. Number: NCT02431182 .

Very late stent thrombosis with second generation drug eluting stents compared to bare metal stents: Network meta-analysis of randomized primary percutaneous coronary intervention trials.

PubMed

Philip, Femi; Stewart, Susan; Southard, Jeffrey A

2016-07-01

The relative safety of drug-eluting stents (DES) and bare-metal stents (BMS) in primary percutaneous coronary intervention (PPCI) in ST elevation myocardial infarction (STEMI) continues to be debated. The long-term clinical outcomes between second generation DES and BMS for primary percutaneous coronary intervention (PCI) using network meta-analysis were compared. Randomized controlled trials comparing stent types (first generation DES, second generation DES, or BMS) were considered for inclusion. A search strategy used Medline, Embase, Cochrane databases, and proceedings of international meetings. Information about study design, inclusion criteria, and sample characteristics were extracted. Network meta-analysis was used to pool direct (comparison of second generation DES to BMS) and indirect evidence (first generation DES with BMS and second generation DES) from the randomized trials. Twelve trials comparing all stents types including 9,673 patients randomly assigned to treatment groups were analyzed. Second generation DES was associated with significantly lower incidence of definite or probable ST (OR 0.59, 95% CI 0.39-0.89), MI (OR 0.59, 95% CI 0.39-0.89), and TVR at 3 years (OR 0.50: 95% CI 0.31-0.81) compared with BMS. In addition, there was a significantly lower incidence of MACE with second generation DES versus BMS (OR 0.54, 95% CI 0.34-0.74) at 3 years. These were driven by a higher rate of TVR, MI and stent thrombosis in the BMS group at 3 years. There was a non-significant reduction in the overall and cardiac mortality [OR 0.83, 95% CI (0.60-1.14), OR 0.88, 95% CI (0.6-1.28)] with the use of second generation DES versus BMS at 3 years. Network meta-analysis of randomized trials of primary PCI demonstrated lower incidence of MACE, MI, TVR, and stent thrombosis with second generation DES compared with BMS. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

The MOSAIC study - comparison of the Maudsley Model of Treatment for Adults with Anorexia Nervosa (MANTRA) with Specialist Supportive Clinical Management (SSCM) in outpatients with anorexia nervosa or eating disorder not otherwise specified, anorexia nervosa type: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Anorexia nervosa (AN) is a biologically based serious mental disorder with high levels of mortality and disability, physical and psychological morbidity and impaired quality of life. AN is one of the leading causes of disease burden in terms of years of life lost through death or disability in young women. Psychotherapeutic interventions are the treatment of choice for AN, but the results of psychotherapy depend critically on the stage of the illness. The treatment response in adults with a chronic form of the illness is poor and drop-out from treatment is high. Despite the seriousness of the disorder the evidence-base for psychological treatment of adults with AN is extremely limited and there is no leading treatment. There is therefore an urgent need to develop more effective treatments for adults with AN. The aim of the Maudsley Outpatient Study of Treatments for Anorexia Nervosa and Related Conditions (MOSAIC) is to evaluate the efficacy and cost effectiveness of two outpatient treatments for adults with AN, Specialist Supportive Clinical Management (SSCM) and the Maudsley Model of Treatment for Adults with Anorexia Nervosa (MANTRA). Methods/Design 138 patients meeting the inclusion criteria are randomly assigned to one of the two treatment groups (MANTRA or SSCM). All participants receive 20 once-weekly individual therapy sessions (with 10 extra weekly sessions for those who are severely ill) and four follow-up sessions with monthly spacing thereafter. There is also optional access to a dietician and extra sessions involving a family member or a close other. Body weight, eating disorder- related symptoms, neurocognitive and psychosocial measures, and service use data are measured during the course of treatment and across a one year follow up period. The primary outcome measure is body mass index (BMI) taken at twelve months after randomization. Discussion This multi-center study provides a large sample size, broad inclusion criteria and a follow-up period. However, the study has to contend with difficulties directly related to running a large multi-center randomized controlled trial and the psychopathology of AN. These issues are discussed. Trial Registration Current Controlled Trials ISRCTN67720902 - A Maudsley outpatient study of treatments for anorexia nervosa and related conditions. PMID:23721562

An Herbal Drug, Gongjin-dan, Ameliorates Acute Fatigue Caused by Short-Term Sleep-Deprivation: A Randomized, Double-Blinded, Placebo-Controlled, Crossover Clinical Trial.

PubMed

Son, Mi Ju; Im, Hwi-Jin; Ku, Boncho; Lee, Jun-Hwan; Jung, So Young; Kim, Young-Eun; Lee, Sung Bae; Kim, Jun Young; Son, Chang-Gue

2018-01-01

Introduction: Gongjin-dan (GJD) is an herbal drug commonly used in Korea and China to combat fatigue, but there are only few clinical studies on its effectiveness and experimental studies on its mechanism of action, and no randomized controlled trial of GJD on the efficacy and mechanism of action has been reported. Here, we performed an exploratory study to evaluate both questions regarding GJD use in humans. Methods: A randomized, double-blinded, placebo-controlled, crossover clinical trial was conducted in the Republic of Korea. Healthy male participants were recruited and randomly allocated to groups receiving GJD-placebo or placebo-GJD in sequence. Fatigue was artificially induced by sleep deprivation for 2 nights. The primary outcome was a change in serum cortisol level; levels of biomarkers for stress hormones as well as oxidative stress and immunologic factors were also assessed, and questionnaires on fatigue and sleep quality were conducted. Results: Twelve and 11 participants were assigned to the GJD-placebo and placebo-GJD groups, respectively. Of all 23 participants, depending on crossover design, we analyzed a total of 20 participants for GJD, and 21 for placebo. An increase in serum cortisol appeared to be attenuated by GJD administration ( p = 0.25), but the effect was not statistically significant; a similar pattern was observed in salivary cortisol levels ( p = 0.14). Overall, GJD showed a tendency to reduce fatigue according to the Brief Fatigue Inventory (BFI, p = 0.07) and the Fatigue Severity Scale (FSS, p = 0.13) questionnaires. BFI and FSS scores in the first stage (before the crossover), however, were significantly improved (BFI, p = 0.02; FSS, p = 0.05) after GJD treatment (relative to placebo). GJD also seemed to improve sleep quality as assessed by the Leeds Sleep Evaluation Questionnaire ( p = 0.06), with a significant improvement specifically in the condition "Getting To Sleep" ( p = 0.02). Five participants experienced minor adverse events, but no adverse events were specific to the GJD administration period. Conclusions: This trial produced the first clinical evidence that GJD might have anti-fatigue properties, especially under sleep deprivation; however, the investigation of cortisol-mediated mechanisms requires further larger-scale studies in the future. World Health Organization International Clinical Trials Registry Platform KCT0001681 (http://apps.who.int/trialsearch/Trial2.aspx?TrialID=KCT0001681).

Effectiveness of a school-community linked program on physical activity levels and health-related quality of life for adolescent girls

PubMed Central

2014-01-01

Background This study evaluated the effectiveness of a school-community program on Health-Related Quality of Life (HRQoL; the primary outcome), physical activity (PA), and potential mediators of PA among adolescent girls living in low-socioeconomic rural/regional settings. Method The study was a cluster-randomized controlled trial. Twelve communities with the requisite sports clubs and facilities were paired according to relevant criteria; one of each pair was randomly assigned to the intervention or control condition. Eight schools per condition were randomly selected from these communities and the intervention was conducted over one school year (2011). Female students in grades 7–9 in intervention schools participated in two 6-session PA units – a sport unit (football or tennis) and a recreational unit (leisure centre-based). These were incorporated into physical education (PE) curriculum and linked to PA opportunities for participation outside school. Students were surveyed at baseline and endpoint, self-reporting impact on primary and secondary outcome measures (HRQoL, PA) and PA mediators (e.g. self-efficacy). Linear mixed models for two-group (intervention, control) and three-group (completers, non-completers, control) analyses were conducted with baseline value, age and BMI as covariates, group as a fixed effect and school as random cluster effect. Results Participants completing baseline and endpoint measures included: 358 intervention (baseline response rate 33.7%, retention rate 61.3%) and 256 control (14.1% and 84.0%). Adjustment for age and BMI made no substantive difference to outcomes, and there were no cluster effects. For HRQoL, after adjustment for baseline scores, the intervention group showed significantly higher scores on all three PedsQL scores (physical functioning: M ± SE = 83.9 ± 0.7, p = .005; psychosocial: 79.9 ± 0.8, p = .001; total score: 81.3 ± 0.7, p = .001) than the control group (80.9 ± 0.8; 76.1 ± 0.9 and 77.8 ± 0.8). The three-group analysis found intervention non-completers had significantly higher PedsQL scores (84.0 ± 0.8, p = .021; 80.4 ± 0.9, p = .003; 81.7 ± 0.8, p = .002;) than controls (80.9 ± 0.8, 76.1 ± 0.9 and 77.8 ± 0.8). There were no significant differences for any PA measure. Intervention completers had significantly higher scores than non-completers and controls for some mediator variables (e.g. self-efficacy, behavioural control). Conclusion Positive outcomes were achieved from a modest school-community linked intervention. The school component contributed to maintaining HRQoL; students who completed the community component derived a range of intra-personal and inter-personal benefits. Trial registration ACTRN12614000446662. April 30th 2014. PMID:24966134

Internet-based interventions for disordered gamblers: study protocol for a randomized controlled trial of online self-directed cognitive-behavioural motivational therapy.

PubMed

Hodgins, David C; Fick, Gordon H; Murray, Robert; Cunningham, John A

2013-01-08

Gambling disorders affect about one percent of adults. Effective treatments are available but only a small proportion of affected individuals will choose to attend formal treatment. As a result, self-directed treatments have also been developed and found effective. Self-directed treatments provide individuals with information and support to initiate a recovery program without attending formal treatment. In previous research we developed an telephone-based intervention package that helps people to be motivated to tackle their gambling problem and to use basic behavioral and cognitive change strategies. The present study will investigate the efficacy of this self-directed intervention offered as a free online resource. The Internet is an excellent modality in which to offer self-directed treatment for gambling problems. The Internet is increasingly accessible to members of the public and is frequently used to access health-related information. Online gambling sites are also becoming more popular gambling platforms. A randomized clinical trial (N=180) will be conducted in which individuals with gambling problems who are not interested in attending formal treatment are randomly assigned to have access to an online self-directed intervention or to a comparison condition. The comparison condition will be an alternative website that offers a self-assessment of gambling involvement and gambling-related problems. The participant's use of the resources and their gambling involvement (days of gambling, dollars loss) and their gambling problems will be tracked for a twelve month follow-up period. The results of this research will be important for informing policy-makers who are developing treatment systems. ISRCTN06220098.

The Role of Eye Movement Desensitization and Reprocessing (EMDR) Therapy in Medicine: Addressing the Psychological and Physical Symptoms Stemming from Adverse Life Experiences

PubMed Central

Shapiro, Francine

2014-01-01

Background: A substantial body of research shows that adverse life experiences contribute to both psychological and biomedical pathology. Eye movement desensitization and reprocessing (EMDR) therapy is an empirically validated treatment for trauma, including such negative life experiences as commonly present in medical practice. The positive therapeutic outcomes rapidly achieved without homework or detailed description of the disturbing event offer the medical community an efficient treatment approach with a wide range of applications. Methods: All randomized studies and significant clinical reports related to EMDR therapy for treating the experiential basis of both psychological and somatic disorders are reviewed. Also reviewed are the recent studies evaluating the eye movement component of the therapy, which has been posited to contribute to the rapid improvement attributable to EMDR treatment. Results: Twenty-four randomized controlled trials support the positive effects of EMDR therapy in the treatment of emotional trauma and other adverse life experiences relevant to clinical practice. Seven of 10 studies reported EMDR therapy to be more rapid and/or more effective than trauma-focused cognitive behavioral therapy. Twelve randomized studies of the eye movement component noted rapid decreases in negative emotions and/or vividness of disturbing images, with an additional 8 reporting a variety of other memory effects. Numerous other evaluations document that EMDR therapy provides relief from a variety of somatic complaints. Conclusion: EMDR therapy provides physicians and other clinicians with an efficient approach to address psychological and physiologic symptoms stemming from adverse life experiences. Clinicians should therefore evaluate patients for experiential contributors to clinical manifestations. PMID:24626074

Glossary of Water Resource Terms.

ERIC Educational Resources Information Center

Titelbaum, Olga Adler

Twelve reference sources were used in the compilation of this glossary of water pollution control terminology. Definitions for 364 words, acronyms, and phrases are included with cross references. (KP)

Nonsurgical treatment of peri-implantitis using an air-abrasive device or mechanical debridement and local application of chlorhexidine. Twelve-month follow-up of a prospective, randomized, controlled clinical study.

PubMed

John, Gordon; Sahm, Narja; Becker, Jürgen; Schwarz, Frank

2015-11-01

The purpose of this prospective, parallel group-designed, randomized controlled clinical study was the evaluation of the effectiveness of an air-abrasive device (AAD) for nonsurgical treatment of peri-implantitis. Twenty five patients, showing at least one implant with initial to moderate peri-implantitis, underwent an oral hygiene programme and were randomly treated using either (1) AAD (amino acid glycine powder) or (2) mechanical debridement using carbon curettes and antiseptic therapy with chlorhexidine digluconate (mechanical debridement (MDA)). Clinical parameters were measured at baseline and 12 months after treatment (e.g. bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL)). At 12 months, the AAD group revealed significantly higher (p < 0.05; unpaired t test) decrease in mean BOP scores when compared with MDA-treated sites (41.2 ± 29.5 vs. 16.6 ± 33.4%). Both groups exhibited comparable PD reductions (AAD = 0.5 ± 0.9 mm vs. MDA = 0.4 ± 0.9 mm) and CAL gains (AAD = 0.6 ± 1.3 mm vs. MDA = 0.5 ± 1.1 mm) (p > 0.05; Mann-Whitney test, respectively). Within its limitations, the present study has indicated that both treatment procedures resulted in comparable but limited CAL gains at 12 months. Furthermore, it could be detected that AAD was associated with significantly higher BOP decrease than MDA. The present results have indicated that nonsurgical therapy of peri-implantitis using both AAD and MDA resulted in comparable PD reductions and CAL gains after 12 months of healing. The BOP reductions were significantly higher in the AAD in comparison to the MDA group. So, AAD may be more effective for nonsurgical therapy of peri-implantitis than MDA.

Evaluation of a Cluster-Randomized Controlled Trial of a Package of Community-Based Maternal and Newborn Interventions in Mirzapur, Bangladesh

PubMed Central

Darmstadt, Gary L.; Choi, Yoonjoung; Arifeen, Shams E.; Bari, Sanwarul; Rahman, Syed M.; Mannan, Ishtiaq; Seraji, Habibur Rahman; Winch, Peter J.; Saha, Samir K.; Ahmed, A. S. M. Nawshad Uddin; Ahmed, Saifuddin; Begum, Nazma; Lee, Anne C. C.; Black, Robert E.; Santosham, Mathuram; Crook, Derrick; Baqui, Abdullah H.

2010-01-01

Background To evaluate a delivery strategy for newborn interventions in rural Bangladesh. Methods A cluster-randomized controlled trial was conducted in Mirzapur, Bangladesh. Twelve unions were randomized to intervention or comparison arm. All women of reproductive age were eligible to participate. In the intervention arm, community health workers identified pregnant women; made two antenatal home visits to promote birth and newborn care preparedness; made four postnatal home visits to negotiate preventive care practices and to assess newborns for illness; and referred sick neonates to a hospital and facilitated compliance. Primary outcome measures were antenatal and immediate newborn care behaviours, knowledge of danger signs, care seeking for neonatal complications, and neonatal mortality. Findings A total of 4616 and 5241 live births were recorded from 9987 and 11153 participants in the intervention and comparison arm, respectively. High coverage of antenatal (91% visited twice) and postnatal (69% visited on days 0 or 1) home visitations was achieved. Indicators of care practices and knowledge of maternal and neonatal danger signs improved. Adjusted mortality hazard ratio in the intervention arm, compared to the comparison arm, was 1.02 (95% CI: 0.80–1.30) at baseline and 0.87 (95% CI: 0.68–1.12) at endline. Primary causes of death were birth asphyxia (49%) and prematurity (26%). No adverse events associated with interventions were reported. Conclusion Lack of evidence for mortality impact despite high program coverage and quality assurance of implementation, and improvements in targeted newborn care practices suggests the intervention did not adequately address risk factors for mortality. The level and cause-structure of neonatal mortality in the local population must be considered in developing interventions. Programs must ensure skilled care during childbirth, including management of birth asphyxia and prematurity, and curative postnatal care during the first two days of life, in addition to essential newborn care and infection prevention and management. Trial Registration Clinicaltrials.gov NCT00198627 PMID:20352087

[Effects of work-related medical rehabilitation in patients with musculoskeletal disorders].

PubMed

Streibelt, M; Hansmeier, T; Müller-Fahrnow, W

2006-06-01

A work-related orientation within medical rehabilitation represents concepts with a stronger focus on the patient's individual vocational requirements and is based on different vocationally-orientated strategies of treatment. "Medical Occupational Orientation" ("Medizinisch-berufliche Orientierung", MBO), the model of Klinik Niedersachsen in Bad Nenndorf, places Functional Capacity Evaluation according to Susan Isernhagen (EFL) at the centre of rehabilitation diagnostics and therapy. This study investigates the effects of the MBO model relative to activities and vocational participation of patients with musculoskeletal disorders faced with vocational problems and on management at the interface between medical and vocational rehabilitation. Presented are findings of a randomized follow-up study aimed at evaluating the MBO model. A total of 494 patients of LVA Westfalen, a regional insurance agency, took part. A need for MBO was diagnosed for 222 patients. These patients were randomly assigned either to the MBO model of treatment (experimental group --> U[+]) or to the conventional medical treatment (control group --> K[+]). Patients without a need for MBO (U[-], K[-]) were treated likewise. The written questionings took place at the beginning (t (1)) and end of rehabilitation (t (2)), as well as six (t (3)) and twelve months (t (4)) after the patients' discharge. Currently, the results are based on the 6-month follow-up. Concerning the activities, an MBO-related effect in the experimental group (U[+]) has been found for the Pain Disability Index (PDI), effect sizes being d (u+) = 0.82; d (k+) = 0.17. The risk of unemployment six months after rehabilitation is decreased for MBO(+) patients who participated in the MBO model. In addition, the clinic can make effective prognosis concerning subsequent participation in vocational rehabilitation for both experimental groups (U[+], U[-]). Established for the first time in a randomized controlled trial, the findings presented show that patients with musculoskeletal disorders who are faced with particular vocational problems will achieve significantly better results concerning activities and vocational reintegration if their medical rehabilitation had been based upon an EFL-centred MBO approach.

Compliance, clinical outcome, and quality of life of patients with stable angina pectoris receiving once-daily betaxolol versus twice daily metoprolol: a randomized controlled trial

PubMed Central

Kardas, Przemyslaw

2007-01-01

Background A randomized, controlled trial was conducted in an outpatient setting to examine the effect of beta-blocker dosing frequency on patient compliance, clinical outcome, and health-related quality of life in patients with stable angina pectoris. Methods One hundred and twelve beta-blockers-naive outpatients with stable angina pectoris were randomized to receive betaxolol, 20 mg once daily or metoprolol tartrate, 50 mg twice daily for 8 weeks. The principal outcome measure was overall compliance measured electronically, whereas secondary outcome measures were drug effectiveness and health-related quality of life. Results The overall compliance was 86.5 ± 21.3% in the betaxolol group versus 76.1 ± 26.3% in the metoprolol group (p < 0.01), and the correct number of doses was taken on 84.4 ± 21.6% and 64.0 ± 31.7% of treatment days, respectively (p < 0.0001). The percentage of missed doses was 14.5 ± 21.5% in the once-daily group and 24.8 ± 26.4% in the twice-daily group (p < 0.01). The percentage of doses taken in the correct time window (58.6% vs 42.0%, p = 0.01), correct interdose intervals (77.4% v 53.1%, p < 0.0001), and therapeutic coverage (85.6% vs 73.7%, p < 0.001) were significantly higher in the once-daily group. Both studied drugs had similar antianginal effectiveness. Health-related quality of life improved in both groups, but this increase was more pronounced in the betaxolol arm in some dimensions. Conclusions The study demonstrates that patient compliance with once-daily betaxolol is significantly better than with twice daily metoprolol. Similarly, this treatment provides better quality of life. These results demonstrate possible therapeutic advantages of once-daily over twice-daily beta-blockers in the treatment of stable angina pectoris. PMID:17580734

Atorvastatin therapy decreases androstenedione and dehydroepiandrosterone sulphate concentrations in patients with polycystic ovary syndrome: randomized controlled study.

PubMed

Sathyapalan, Thozhukat; Smith, Karen A; Coady, Anne-Marie; Kilpatrick, Eric S; Atkin, Stephen L

2012-01-01

Hyperandrogenaemia in polycystic ovary syndrome (PCOS) represents a composite of raised serum concentrations of testosterone, androstenedione, dehydroepiandrosterone (DHEA) and DHEA sulphate (DHEAS). In patients with PCOS, testosterone and androstenedione are primarily derived from the ovaries and DHEAS is a metabolite predominantly from the adrenals. It has been shown that atorvastatin reduces testosterone concentrations in patients with PCOS. The objective was to study the effect of atorvastatin on serum androstenedione and DHEAS concentrations in patients with PCOS. A randomized, double-blind, placebo-controlled study was performed. Forty medication-naive patients with PCOs were randomized to either atorvastatin 20mg daily or placebo for three months. Subsequently, a three-month extension study for all patients was undertaken with metformin 1500 mg daily. The main outcome measures were change in androstenedione and DHEAS concentrations. The mean (SD) baseline androstenedione (5.7 [0.8] versus 5.6 [1.3] nmol/L; P = 0.69) and DHEAS (7.1 [1.0] versus 7.2 [1.2] μmol/L; P = 0.72) concentrations were comparable between two groups. There was a significant reduction of androstenedione (5.7 [0.8] versus 4.7 [0.7] nmol/L; P = 0.03) and DHEAS (7.1 [1.0] versus 6.0 [0.9] μmol/L; P = 0.02) with three months of atorvastatin while there were no significant changes with placebo. Three months' treatment with metformin maintained the reduction of androstenedione and DHEAS concentrations with atorvastatin compared with baseline. There were no changes in either DHEAS or androstenedione concentrations in the initial placebo group after 12 weeks of metformin. Twelve weeks of atorvastatin significantly reduced both DHEAS and androstenedione contributing to the total reduction of androgen concentrations and indicating that the reduction of the hyperandrogenaemia could be partly due to the action of atorvastatin at both the ovary and the adrenal gland in PCOS.

A systematic review and meta-analysis of randomized controlled trials of the effect of konjac glucomannan, a viscous soluble fiber, on LDL cholesterol and the new lipid targets non-HDL cholesterol and apolipoprotein B.

PubMed

Ho, Hoang Vi Thanh; Jovanovski, Elena; Zurbau, Andreea; Blanco Mejia, Sonia; Sievenpiper, John L; Au-Yeung, Fei; Jenkins, Alexandra L; Duvnjak, Lea; Leiter, Lawrence; Vuksan, Vladimir

2017-05-01

Background: Evidence from randomized controlled trials (RCTs) suggests the consumption of konjac glucomannan (KJM), a viscous soluble fiber, for improving LDL-cholesterol concentrations. It has also been suggested that the cholesterol-lowering potential of KJM may be greater than that of other fibers. However, trials have been relatively scarce and limited in sample size and duration, and the effect estimates have been inconsistent. The effect of KJM on new lipid targets of cardiovascular disease (CVD) risk is also unknown. Objective: This systematic review and meta-analysis aimed to assess the effect of KJM on LDL cholesterol, non-HDL cholesterol, and apolipoprotein B. Design: Medline, Embase, CINAHL, and the Cochrane Central databases were searched. We included RCTs with a follow-up of ≥3 wk that assessed the effect of KJM on LDL cholesterol, non-HDL cholesterol, or apolipoprotein B. Data were pooled by using the generic inverse-variance method with random-effects models and expressed as mean differences (MDs) with 95% CIs. Heterogeneity was assessed by the Cochran Q statistic and quantified by the I 2 statistic. Results: Twelve studies ( n = 370), 8 in adults and 4 in children, met the inclusion criteria. KJM significantly lowered LDL cholesterol (MD: -0.35 mmol/L; 95% CI: -0.46, -0.25 mmol/L) and non-HDL cholesterol (MD: -0.32 mmol/L; 95% CI: -0.46, -0.19 mmol/L). Data from 6 trials suggested no impact of KJM on apolipoprotein B. Conclusions: Our findings support the intake of ∼3 g KJM/d for reductions in LDL cholesterol and non-HDL cholesterol of 10% and 7%, respectively. The information may be of interest to health agencies in crafting future dietary recommendations related to reduction in CVD risk. This study was registered at clinicaltrials.gov as NCT02068248. © 2017 American Society for Nutrition.

The transcriptional control machinery as well as the cell wall integrity and its regulation are involved in the detoxification of the organic solvent dimethyl sulfoxide in Saccharomyces cerevisiae.

PubMed

Zhang, Lilin; Liu, Ningning; Ma, Xiao; Jiang, Linghuo

2013-03-01

In the present study, we have identified 339 dimethyl sulfoxide (DMSO)-sensitive and nine DMSO-tolerant gene mutations in Saccharomyces cerevisiae through a functional genomics approach. Twelve of these identified DMSO-sensitive mutations are of genes involved in the general control of gene expression mediated by the SWR1 complex and the RNA polymerase II mediator complex, whereas 71 of them are of genes involved in the protein trafficking and vacuolar sorting processes. In addition, twelve of these DMSO-sensitive mutations are of genes involved in the cell wall integrity (CWI) and its regulation. DMSO-tolerant mutations are of genes mainly involved in the metabolism and the gene expression control. Therefore, the transcriptional control machinery, the CWI and its regulation as well as the protein trafficking and sorting process play critical roles in the DMSO detoxification in yeast cells. © 2012 Federation of European Microbiological Societies. Published by Blackwell Publishing Ltd. All rights reserved.

A whole-grain cereal-based diet lowers postprandial plasma insulin and triglyceride levels in individuals with metabolic syndrome.

PubMed

Giacco, R; Costabile, G; Della Pepa, G; Anniballi, G; Griffo, E; Mangione, A; Cipriano, P; Viscovo, D; Clemente, G; Landberg, R; Pacini, G; Rivellese, A A; Riccardi, G

2014-08-01

Until recently, very few intervention studies have investigated the effects of whole-grain cereals on postprandial glucose, insulin and lipid metabolism, and the existing studies have provided mixed results. The objective of this study was to evaluate the effects of a 12-week intervention with either a whole-grain-based or a refined cereal-based diet on postprandial glucose, insulin and lipid metabolism in individuals with metabolic syndrome. Sixty-one men and women age range 40-65 years, with the metabolic syndrome were recruited to participate in this study using a parallel group design. After a 4-week run-in period, participants were randomly assigned to a 12-week diet based on whole-grain products (whole-grain group) or refined cereal products (control group). Blood samples were taken at the beginning and end of the intervention, both fasting and 3 h after a lunch, to measure biochemical parameters. Generalized linear model (GLM) was used for between-group comparisons. Overall, 26 participants in the control group and 28 in the whole-grain group completed the dietary intervention. Drop-outs (five in the control and two in the whole-grain group) did not affect randomization. After 12 weeks, postprandial insulin and triglyceride responses (evaluated as average change 2 and 3 h after the meal, respectively) decreased by 29% and 43%, respectively, in the whole-grain group compared to the run-in period. Postprandial insulin and triglyceride responses were significantly lower at the end of the intervention in the whole-grain group compared to the control group (p = 0.04 and p = 0.05; respectively) whereas there was no change in postprandial response of glucose and other parameters evaluated. A twelve week whole-grain cereal-based diet, compared to refined cereals, reduced postprandial insulin and triglycerides responses. This finding may have implications for type 2 diabetes risk and cardiovascular disease. Copyright © 2014 Elsevier B.V. All rights reserved.

A cognitive-motor intervention using a dance video game to enhance foot placement accuracy and gait under dual task conditions in older adults: a randomized controlled trial.

PubMed

Pichierri, Giuseppe; Murer, Kurt; de Bruin, Eling D

2012-12-14

Computer-based interventions have demonstrated consistent positive effects on various physical abilities in older adults. This study aims to compare two training groups that achieve similar amounts of strength and balance exercise where one group receives an intervention that includes additional dance video gaming. The aim is to investigate the different effects of the training programs on physical and psychological parameters in older adults. Thirty-one participants (mean age ± SD: 86.2 ± 4.6 years), residents of two Swiss hostels for the aged, were randomly assigned to either the dance group (n = 15) or the control group (n = 16). The dance group absolved a twelve-week cognitive-motor exercise program twice weekly that comprised progressive strength and balance training supplemented with additional dance video gaming. The control group performed only the strength and balance exercises during this period. Outcome measures were foot placement accuracy, gait performance under single and dual task conditions, and falls efficacy. After the intervention between-group comparison revealed significant differences for gait velocity (U = 26, P = .041, r = .45) and for single support time (U = 24, P = .029, r = .48) during the fast walking dual task condition in favor of the dance group. No significant between-group differences were observed either in the foot placement accuracy test or in falls efficacy. There was a significant interaction in favor of the dance video game group for improvements in step time. Significant improved fast walking performance under dual task conditions (velocity, double support time, step length) was observed for the dance video game group only. These findings suggest that in older adults a cognitive-motor intervention may result in more improved gait under dual task conditions in comparison to a traditional strength and balance exercise program. This trial has been registered under ISRCTN05350123 (www.controlled-trials.com)

Weight Loss Associated with Cholinesterase Inhibitors In Patients With Dementia in a National Healthcare System

PubMed Central

Sheffrin, Meera; Miao, Yinghui; Boscardin, W. John; Steinman, Michael A.

2016-01-01

Background/Objectives Inconsistent data from randomized trials suggest cholinesterase inhibitors may cause weight loss. We sought to determine if the initiation of cholinesterase inhibitors is associated with significant weight loss in a real-word clinical setting. Design Retrospective cohort study from 2007-2010, comparing weight loss in patients with dementia newly prescribed cholinesterase inhibitors and patients newly prescribed other chronic medications Setting National Veterans Affairs (VA) data Participants Patients 65 years or older with a diagnosis of dementia who received a new prescription for a cholinesterase inhibitor or other new other chronic medication. Measurements The primary outcome was time to 10 pound weight loss over 12 months. We used propensity score matching patients to control for the likelihood of receiving a cholinesterase inhibitor based on baseline characteristics. Data were analyzed in a priori defined subgroups by age, comorbid burden, and initial weight. Results Of 6,504 patients that met study criteria, 1188 patients started on cholinesterase inhibitors were matched to 2189 patients started on other medications. The propensity-matched cohorts were well balanced on baseline covariates. Patients initiated on cholinesterase inhibitors had a higher risk of weight loss compared to matched controls at 12 months, HR 1.23 (95% CI 1.07 - 1.41). At twelve months, 29.3% of patients on cholinesterase inhibitors had experienced weight loss compared to 22.8% of non-users, corresponding to a number needed to harm of 21.2 (95% CI 12.5 – 71.4) over one year. There were no significant differences across subgroups. Conclusion Patients with dementia started on cholinesterase inhibitors had a higher risk of clinically significant weight loss over a 12-month period compared to matched controls. These results are consistent with the available data from randomized controlled trials. Clinicians should consider the risk of weight loss when prescribing cholinesterase inhibitors. PMID:26234945

Detection of domestic violence by community mental health teams: a multi-center, cluster randomized controlled trial.

PubMed

Ruijne, Roos E; Howard, Louise M; Trevillion, Kylee; Jongejan, Femke E; Garofalo, Carlo; Bogaerts, Stefan; Mulder, Cornelis L; Kamperman, Astrid M

2017-08-07

Domestic Violence and Abuse (DVA) is associated with a range of psychosocial and mental health problems. Having a psychiatric illness increases likelihood of being a victim of DVA. Despite the evidence of a high risk for DVA and the serious effects of violent victimization in psychiatric patients, detection rates are low and responses are inadequate. The aim of the BRAVE (Better Reduction trough Assessment of Violence and Evaluation) study is to improve detection of and response to DVA in psychiatric patients. In this article, we present the protocol of the BRAVE study which follows the SPIRIT guidelines. The BRAVE study is a cluster randomized controlled trial. We will include 24 community mental health teams from Rotterdam and The Hague. Twelve teams will provide care as usual and 12 teams will receive the intervention. The intervention consists of 1) a knowledge and skills training for mental health professionals about DVA, 2) a knowledge and skills training of DVA professionals about mental illness, 3) provision and implementation of a referral pathway between community mental health and DVA services. The follow up period is 12 months. Our primary outcome is the rate of detected cases of recent or any history of DVA in patients per team in 12 months. Detection rates are obtained through a systematic search in electronic patient files. Our secondary aims are to obtain information about the gain and sustainability of knowledge on DVA in mental health professionals, and to obtain insight into the feasibility, sustainability and acceptability of the intervention. Data on our secondary aims will be obtained through structured in depth interviews and a questionnaire on knowledge and attitudes on DVA. This study is the first cluster randomized controlled trial to target both male and female psychiatric patients that experience DVA, using an intervention that involves training of professionals. We expect the rate of detected cases of DVA to increase in the intervention teams. With early detection of victimization of DVA in psychiatric patients we hope to improve the mental health of psychiatric patients in the short and long term. ISRCTN:14115257 . Date of registration: 15th January 2015.

Improving mental health among ultra-poor children: Two-year outcomes of a cluster-randomized trial in Burkina Faso.

PubMed

Ismayilova, Leyla; Karimli, Leyla; Sanson, Jo; Gaveras, Eleni; Nanema, Rachel; Tô-Camier, Alexice; Chaffin, Josh

2018-07-01

There is limited evidence about interventions improving child mental health in francophone West Africa. Behavioral mental health interventions alone may have limited effects on children's emotional well-being in families living in abject poverty, especially in low-income countries. This study tests the effects of economic intervention, alone and in combination with a family-focused component, on the mental health of children from ultra-poor households in rural Burkina Faso. The three-arm cluster randomized trial included children in the age range of 10-15 years old (N = 360), from twelve villages in Nord region of Burkina Faso (ClinicalTrial.gov ID: NCT02415933). Villages were randomized (4 villages/120 households per arm) to the waitlist arm, the economic intervention utilizing the Graduation approach (Trickle Up/TU arm), or to the economic strengthening plus family coaching component (TU + arm). Intervention effects were tested using repeated-measures mixed-effects regressions that account for the clustered nature of the data. Children from the TU + arm showed a reduction in depressive symptoms at 12 months (medium effect size Cohen's d = -0.41, p = .001) and 24 months (d = -0.39, p = .025), compared to the control condition and the economic intervention alone (at 12 months d = -0.22, p = .020). Small effect size improvements in self-esteem were detected in the TU + group, compared to the control arm at 12 months (d = 0.21) and to the TU arm at 24 months (d = 0.21). Trauma symptoms significantly reduced in the TU + group at 12 months (Incidence Risk Ratio/IRR = 0.62, 95% CI = 0.41, 0.92, p = .042), compared to the control group. Integrating psychosocial intervention involving all family members with economic empowerment strategies may be an innovative approach for improving emotional well-being among children living in extreme poverty. Copyright © 2018 Elsevier Ltd. All rights reserved.

Effectiveness and cost-effectiveness of a self-management training for patients with chronic and treatment resistant anxiety or depressive disorders: design of a multicenter randomized controlled trial.

PubMed

Zoun, Maringa H H; Koekkoek, Bauke; Sinnema, Henny; Muntingh, Anna D T; van Balkom, Anton J L M; Schene, Aart H; Smit, Filip; Spijker, Jan

2016-07-07

Many patients with anxiety or depressive disorders achieve no remission of their symptoms after evidence-based treatment algorithms. They develop a chronic course of the disorder. Current care for these patients usually consists of long-term supportive contacts with a community psychiatric nurse and pharmacological management by a psychiatrist. Data on the effectiveness of these treatments is lacking. A psychosocial rehabilitation approach, where self-management is an increasingly important part, could be more suitable. It focuses on the restoration of functioning and enhancement of patients' autonomy and responsibility. Treatment with this focus, followed by referral to primary care, may be more (cost-)effective. A multicenter randomized controlled trial is designed for twelve participating specialized outpatient mental health services in the Netherlands. Patients with chronic and treatment resistant anxiety or depressive disorders, currently receiving supportive care in specialized outpatient mental health care, are asked to participate. After inclusion, patients receive the baseline questionnaire and are randomized to the intervention group or the usual care control group. The intervention focuses on rehabilitation and self-management and is provided by a trained community psychiatric nurse, followed by referral to primary care. Measurements take place at 6, 12, and 18 months after baseline. This study evaluates both the effectiveness (on quality of life, symptom severity, and empowerment), and cost-effectiveness of the intervention compared to usual care. In addition, a questionnaire is designed to get insight in which self-management strategies patients use to manage their disorder, and in the experiences of patients with the change of care setting. In this study we evaluate the effectiveness and cost-effectiveness of a self-management intervention for patients with chronic and treatment resistant anxiety or depressive disorders in specialized outpatient mental health care. The results of this study may provide a first 'proof-of-concept' in this under-researched but important field, and might be relevant for a large group of patients in the context of a transition of the Dutch health care system. Netherlands Trial Register: NTR3335 , registered 7 March 2012.

Meta-analysis of organizational skills interventions for children and adolescents with Attention-Deficit/Hyperactivity Disorder.

PubMed

Bikic, Aida; Reichow, Brian; McCauley, Spencer A; Ibrahim, Karim; Sukhodolsky, Denis G

2017-03-01

In addition to problems with attention and hyperactivity, children with ADHD present with poor organizational skills required for managing time and materials in academic projects. Organizational skills training (OST) has been increasingly used to address these deficits. We conducted a systematic review and meta-analysis of OST in children with ADHD. The objective of this study was to systematically review the evidence of the effects of OST for children with ADHD for organizational skills, attention, and academic performance. We searched 3 electronic databases to locate randomized controlled trials published in English in peer-reviewed journals comparing OST with parent education, treatment-as-usual, or waitlist control conditions. Standardized mean difference effect sizes from the studies were statistically combined using a random-effects meta-analyses across six outcomes: teacher- and parent-rated organizational skills, teacher- and parent-rated inattention, teacher-rated academic performance, and Grade Point Average (GPA). Risk of bias was assessed for randomization, allocation concealment, blinding of participants and treatment personnel, blinding of outcome assessors, incomplete outcome data, and selective outcome reporting. Twelve studies involving 1054 children (576 treatment, 478 control) were included in the meta-analyses. Weighted mean effect sizes for teacher- and parent-rated outcome measures of organizational skills were g=0.54 (95% CI 0.17 to 0.91) and g=0.83 (95% CI 0.32 to 1.34), respectively. Weighted mean effect sizes of teacher- and parent-rated symptoms of inattention were g=0.26 (95% CI 0.01 to 0.52) and g=0.56 (95% CI 0.38 to 0.74), respectively. Weighted standardized mean effect size for teacher-rated academic performance and GPA were g=0.33 (95% CI 0.14 to 0.51) and g=0.29 (95% CI 0.07 to 0.51), respectively. OST leads to moderate improvements in organizational skills of children with ADHD as rated by teachers and large improvements as rated by parents. More modest improvements were observed on the ratings of symptoms of inattention and academic performance. PROSPERO (CRD42015019261). Copyright © 2016 Elsevier Ltd. All rights reserved.

The reduction of disability in community-dwelling frail older people: design of a two-arm cluster randomized controlled trial.

PubMed

Metzelthin, Silke F; van Rossum, Erik; de Witte, Luc P; Hendriks, Marike R C; Kempen, Gertrudis I J M

2010-08-23

Frailty among older people is related to an increased risk of adverse health outcomes such as acute and chronic diseases, disability and mortality. Although many intervention studies for frail older people have been reported, only a few have shown positive effects regarding disability prevention. This article presents the design of a two-arm cluster randomized controlled trial on the effectiveness, cost-effectiveness and feasibility of a primary care intervention that combines the most promising elements of disability prevention in community-dwelling frail older people. In this study twelve general practitioner practices were randomly allocated to the intervention group (6 practices) or to the control group (6 practices). Three thousand four hundred ninety-eight screening questionnaires including the Groningen Frailty Indicator (GFI) were sent out to identify frail older people. Based on their GFI score (≥5), 360 participants will be included in the study. The intervention will receive an interdisciplinary primary care intervention. After a comprehensive assessment by a practice nurse and additional assessments by other professionals, if needed, an individual action plan will be defined. The action plan is related to a flexible toolbox of interventions, which will be conducted by an interdisciplinary team. Effects of the intervention, both for the frail older people and their informal caregivers, will be measured after 6, 12 and 24 months using postal questionnaires and telephone interviews. Data for the process evaluation and economic evaluation will be gathered continuously over a 24-month period. The proposed study will provide information about the usefulness of an interdisciplinary primary care intervention. The postal screening procedure was conducted in two cycles between December 2009 and April 2010 and turned out to be a feasible method. The response rate was 79.7%. According to GFI scores 29.3% of the respondents can be considered as frail (GFI ≥ 5). Nearly half of them (48.1%) were willing to participate. The baseline measurements started in January 2010. In February 2010 the first older people were approached by the practice nurse for a comprehensive assessment. Data on the effect, process, and economic evaluation will be available in 2012. ISRCTN31954692.

The Stroke Oxygen Study (SO2S) - a multi-center, study to assess whether routine oxygen treatment in the first 72 hours after a stroke improves long-term outcome: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Mild hypoxia is common in stroke patients and may have significant adverse effects on the ischemic brain after stroke. The use of oxygen treatment is rapidly increasing in European stroke units but is not without side effects. It impedes early mobilization, could pose an infection risk, and may encourage the formation of toxic free radicals, leading to further damage to the ischemic brain. In the Stroke Oxygen Pilot Study (2 or 3 L/min for 72 hours) neurological recovery at one week was better in the oxygen group than in controls, and after correction for difference in baseline stroke severity and prognostic factors, there was a trend to better outcome with oxygen at six months. Oxygen was as effective in mild as in severe strokes. Oxygen saturation is lower at night than during the day, and episodes of oxygen desaturation are common during sleep. Nocturnal oxygen supplementation is likely to reduce the burden of hypoxia without interfering with daytime mobilization and rehabilitation. Before wider use of oxygen supplementation becomes established it is important to obtain better evidence on which patients benefit from such treatment. Methods Participants will be randomized to one of three groups: the first will receive continuous oxygen for 72 hours (at a rate of 2 or 3 L/min depending on baseline oxygen saturation), the second group will receive nocturnal oxygen only (at a rate of 2 or 3 L/min depending on baseline oxygen saturation) and the third group will not receive any oxygen (control). A baseline assessment is performed at randomization and a one-week follow-up completed. Outcome data at three, six and twelve months will be obtained via a questionnaire sent to the patient by the trial center. Discussion This study will provide evidence on the effectiveness of oxygen supplementation for the treatment of stroke and whether nocturnal oxygen is a potentially beneficial therapy regimen. Trial registration This trial is registered with the ISRCTN register ID number ISRCTN52416964 PMID:24684940

The effectiveness of beauty care on self-rated health among community-dwelling older people.

PubMed

Kawai, Hisashi; Inomata, Takashi; Otsuka, Rika; Sugiyama, Yoichi; Hirano, Hirohiko; Obuchi, Shuichi

2016-01-01

The maintenance and improvement of self-rated health is important for prolonging healthy life expectancy in a well-aged society. In the present study, we examined the effectiveness of beauty care on self-rated health among community-dwelling older people through a quasi- randomized controlled trial by propensity score matching (PSM). One hundred twelve community-dwelling older people who were recruited from the local community, participated in a beauty care program that consisted of two training sessions per month for 3 months and daily enforcement of facial skin care (intervention group). Seven hundred fifty-nine participants who received a comprehensive geriatric assessment were treated as a control group. Sex, age, BMI, lifestyle habits, hand grip strength, walking speed, skeletal muscle mass, bone density, medical history and life function (Kihon Checklist) were matched by the PSM method. We compared the subjects' self-rated health, depressive mood status (self-rating depression scale: SDS), and the frequency of going outdoors in the intervention and control groups before and after intervention. The improvements of SDS were significantly greater in the intervention group than in the control group. The self-rated health and the frequency of going outdoors were maintained in the intervention group but were significantly decreased in the control group. We conclude that beauty care is effective for maintaining and improving the self-rated health and depression status of community-dwelling older people and that it may help prolong healthy life expectancy.

Job stressors in naval personnel serving on ships and in personnel serving ashore over a twelve month period.

PubMed

Bridger, R S; Brasher, K; Dew, A; Kilminster, S

2011-07-01

Sixty one percent of respondents to a questionnaire survey of occupational stress (Phase I) returned follow-up questionnaires twelve months later (Phase II). The Phase I questionnaire measured psychological strain resulting from exposure to occupational stressors, and measured the presence of stress buffers and demographic, psychological and lifestyle-related confounding factors, including age, rank and gender, mood state and the occurrence of stressful life events outside of work. The prevalence of strain was 31% at Phase I and 33% at Phase II. Fifty percent of personnel had no strain on either occasion, 15% had strain on both occasions and the remainder had strain on one occasion. The main stressor associated with strain at Phase I was an inability to disengage from work and this stressor accounted for a greater proportion of the variance in strain in personnel serving on ships than those serving ashore. The twelve-month follow-up questionnaire (Phase II) re-assessed psychological strain. A multiple linear regression analysis was conducted to identify factors measured at Phase I that predicted strain at Phase II in previously strain-free individuals. A lack of autonomy and control and dissatisfaction with living conditions predicted strain twelve months later in those serving on ships. Of the living conditions assessed, lack of privacy was the most strongly associated with strain twelve months later in those serving on ships. These stressors were not associated with strain twelve months later in those serving ashore. The findings suggest that improvements to the design of the environment on ships may have benefits for the psychological health of personnel. Crown Copyright © 2010. Published by Elsevier Ltd. All rights reserved.

Environmental Control for Regional Library Facilities. RR-80-3.

ERIC Educational Resources Information Center

King, Richard G., Jr.

This report presents an overview of the damage to library materials caused by uncontrollable environmental variables. The control of atmospheric pollutants, temperature, and humidity are discussed with regard to damage, standards, and the costs of deterioration due to these factors. Twelve references are listed. (FM)

Biochemical Changes in Postmenopausal Women Following a Muscle Fitness Program.

ERIC Educational Resources Information Center

Snow-Harter, Christine

1987-01-01

Twelve postmenopausal women attending a 50 minute exercise class three times a week for eight weeks were compared with 10 controls who maintained sedentary routines. Results showed that the exercise group had higher serum alkaline phosphatase and lower serum calcium than the controls. (Author/CB)

Supportive monitoring and disease management through the internet: an internet-delivered intervention strategy for recurrent depression.

PubMed

Kordy, Hans; Backenstrass, Matthias; Hüsing, Johannes; Wolf, Markus; Aulich, Kai; Bürgy, Martin; Puschner, Bernd; Rummel-Kluge, Christine; Vedder, Helmut

2013-11-01

Major depression is a highly prevalent, disabling disorder associated with loss of quality of life and large economic burden for the society. Depressive disorders often follow a chronic or recurrent course. The risk of relapses increases with each additional episode. The internet-deliverable intervention strategy SUMMIT (SUpportive Monitoring and Disease Management over the InTernet) for patients with recurrent depression has been developed with the main objectives to prolong symptom-free phases and to shorten symptom-loaden phases. This paper describes the study design of a six-sites, three-arm, randomized clinical trial intended to evaluate the efficacy of this novel strategy compared to treatment as usual (TAU). Two hundred thirty six patients who had been treated for their (at least) third depressive episode in one of the six participating psychiatric centers were randomized into one of three groups: 1) TAU plus a twelve-month SUMMIT program participation with personal support or 2) TAU plus a twelve-month SUMMIT program participation without personal support, or 3) TAU alone. Primary outcome of this study is defined as the number of "well weeks" over 24months after index treatment assessed by blind evaluators based on the Longitudinal Interval Follow-Up Evaluation. If efficacious, the low monetary and nonmonetary expenditures of this automated, yet individualized intervention may open new avenues for providing an acceptable, convenient, and affordable long-term disease management strategy to people with a chronic mental condition such as recurrent depression. © 2013.

Effects of dietary supplementation of active dried yeast on fecal methanogenic archaea diversity in dairy cows.

PubMed

Jin, Dingxing; Kang, Kun; Wang, Hongze; Wang, Zhisheng; Xue, Bai; Wang, Lizhi; Xu, Feng; Peng, Quanhui

2017-04-01

This study aimed to investigate the effects of dietary supplementation of different dosages of active dried yeast (ADY) on the fecal methanogenic archaea community of dairy cattle. Twelve multiparous, healthy, mid-lactating Holstein dairy cows (body weight: 584 ± 23.2 kg, milk produced: 26.3 ± 1.22 kg/d) were randomly assigned to one of three treatments (control, ADY2, and ADY4) according to body weight with four replicates per treatment. Cows in the control group were fed conventional rations without ADY supplementation, while cows in the ADY2 and ADY4 group were fed rations supplemented with ADY at 2 or 4 g/d/head. Real-time PCR analysis showed the populations of total methanogens in the feces were significantly decreased (P < 0.05) in the ADY4 group compared with control. High-throughput sequencing technology was applied to examine the differences in methanogenic archaea diversity in the feces of the three treatment groups. A total of 155,609 sequences were recovered (a mean of 12,967 sequences per sample) from the twelve fecal samples, which consisted of a number of operational taxonomic units (OTUs) ranging from 1451 to 1,733, were assigned to two phyla, four classes, five orders, five families and six genera. Bioinformatic analyses illustrated that the natural fecal archaeal community of the control group was predominated by Methanobrevibacter (86.9% of the total sequence reads) and Methanocorpusculum (10.4%), while the relative abundance of the remaining four genera were below 1% with Methanosphaera comprising 0.8%, Thermoplasma composing 0.4%, and the relative abundance of Candidatus Nitrososphaera and Halalkalicoccus being close to zero. At the genus level, the relative abundances of Methanocorpusculum and Thermoplasma were increased (P < 0.05) with increasing dosage of ADY. Conversely, the predominant methanogen genus Methanobrevibacter was decreased with ADY dosage (P < 0.05). Dietary supplementation of ADY had no significant effect (P > 0.05) on the abundances of genera unclassified, Candidatus Nitrososphaera, and Halalkalicoccus. In conclusion, supplementation of ADY to the rations of dairy cattle could alter the population sizes and composition of fecal methanogenic archaea in the feces of dairy cattle. The decrease in Methanobrevibacter happened with a commensurate increase in the genera Methanocorpusculum and Thermoplasma. Copyright © 2017 Elsevier Ltd. All rights reserved.

Specific Effects of Acute Moderate Exercise on Cognitive Control

ERIC Educational Resources Information Center

Davranche, Karen; McMorris, Terry

2009-01-01

The main issue of this study was to determine whether cognitive control is affected by acute moderate exercise. Twelve participants [4 females (VO[subscript 2 max]=42 ml/kg/min) and 8 males (VO[subscript 2 max]=48 ml/kg/min)] performed a Simon task while cycling at a carefully controlled workload intensity corresponding to their individual…

Fine Motor Control Is Related to Cognitive Control in Adolescents with Down Syndrome

ERIC Educational Resources Information Center

Chen, Chih-Chia; Ringenbach, Shannon D. R.; Albert, Andrew; Semken, Keith

2014-01-01

The connection between human cognitive development and motor functioning has been systematically examined in many typical and atypical populations; however, only a few studies focus on people with Down syndrome (DS). Twelve adolescents with DS participated and their cognitive control, measured by the Corsi-Block tapping test (e.g., visual working…

Effect of aquatic versus land based exercise programs on physical performance in severely burned patients: a randomized controlled trial.

PubMed

Zoheiry, Ibrahim M; Ashem, Haidy N; Ahmed, Hamada Ahmed Hamada; Abbas, Rami

2017-12-01

[Purpose] To compare the effect of an aquatic-based versus a land-based exercise regimen on the physical performance of severely burned patients. [Subjects and Methods] Forty patients suffering from severe burn (total body surface area more than 30%) were recruited from several outpatient clinics in Greater Cairo. Their ages ranged between 20 to 40 years and were randomly assigned into two equal groups: group (A), which received an aquatic based exercise program, and group (B), which received a land-based exercise program. The exercise program, which took place in 12 consecutive weeks, consisted of flexibility, endurance, and lower and upper body training. Physical performance was assessed using 30 seconds chair stand test, stair climb test, 30 meter fast paced walk test, time up and go test, 6-minute walk test and a VO2max evaluation. [Results] Significantly increase in the 30 second chair stand, 6-minute walk, 30 meter fast paced walk, stair climb, and VO2 max tests and significantly decrease in the time up and go test in group A (aquatic based exercise) compared with group B (a land-based exercise) at the post treatment. [Conclusion] Twelve-week program of an aquatic program yields improvement in both physical performance and VO2 max in patients with severe burns.

Randomized study of the effect of video education on heart failure healthcare utilization, symptoms, and self-care behaviors.

PubMed

Albert, Nancy M; Buchsbaum, Robin; Li, Jianbo

2007-12-01

Adherence to self-care behaviors improves heart failure (HF) morbidity and life quality. We examined short-term impact of video education (VE) in addition to standard education (SE) on HF healthcare utilization and self-care behavior adherence. One hundred and twelve hospitalized patients were randomly assigned to SE (n=53) or SE plus VE (n=59). Differences between groups were analyzed in patients who underwent 3-month follow-up (39 SE and 37 VE patients). Mean age was 60+/-14 years; mean HF length was 57 months. Three-month healthcare utilization was similar between groups but VE patients needed less extra diuretic dosing (P<0.02), received more HF literature (P<0.03), and had less healthcare team telephone communication (P<0.04). VE patients had greater sign/symptom reduction (P<0.04); especially related to edema (P<0.01) and fatigue (P<0.01) and initiated more actions for edema (P<0.05) and dyspnea (with exercise or rest, both P<0.01). Overall, VE patients had a higher mean self-care behavior score (P<0.01), reflecting greater self-care adherence. Video education prompts self-care behavior adherence to control worsening signs/symptoms of volume overload. During 3-month follow-up, utilization of most healthcare resources was unchanged. VE is a useful adjunct to in-person education.

A randomized controlled trial for obesity and binge eating disorder: Low-energy-density dietary counseling and cognitive behavioral therapy

PubMed Central

Masheb, Robin M.; Grilo, Carlos M.; Rolls, Barbara J.

2011-01-01

The present study examined a dietary approach – lowering energy density – for producing weight loss in obese patients with binge eating disorder (BED) who also received cognitive-behavioral therapy (CBT) to address binge eating. Fifty consecutive participants were randomly assigned to either a six-month individual treatment of CBT plus a low-Energy-Density diet (CBT+ED) or CBT plus General Nutrition counseling not related to weight loss (CBT+GN). Assessments occurred at six- and twelve-months. Eighty-six percent of participants completed treatment, and of these, 30% achieved at least a 5% weight loss with rates of binge remission ranging from 55–75%. The two treatments did not differ significantly in weight loss or binge remission outcomes. Significant improvements were found for key dietary and metabolic outcomes, with CBT+ED producing significantly better dietary outcomes on energy density, and fruit and vegetable consumption, than CBT+GN. Reductions in energy density and weight loss were significantly associated providing evidence for the specificity of the treatment effect. These favorable outcomes, and that CBT+ED was significantly better at reducing energy density and increasing fruit and vegetable consumption compared to CBT+GN, suggest that low-energy-density dietary counseling has promise as an effective method for enhancing CBT for obese individuals with BED. PMID:22005587

Effects of Physical-Cognitive Dual Task Training on Executive Function and Gait Performance in Older Adults: A Randomized Controlled Trial

PubMed Central

Falbo, S.; Condello, G.; Capranica, L.; Forte, R.

2016-01-01

Physical and cognitive training seem to counteract age-related decline in physical and mental function. Recently, the possibility of integrating cognitive demands into physical training has attracted attention. The purpose of this study was to evaluate the effects of twelve weeks of designed physical-cognitive training on executive cognitive function and gait performance in older adults. Thirty-six healthy, active individuals aged 72.30 ± 5.84 years were assigned to two types of physical training with major focus on physical single task (ST) training (n = 16) and physical-cognitive dual task (DT) training (n = 20), respectively. They were tested before and after the intervention for executive function (inhibition, working memory) through Random Number Generation and for gait (walking with/without negotiating hurdles) under both single and dual task (ST, DT) conditions. Gait performance improved in both groups, while inhibitory performance decreased after exercise training with ST focus but tended to increase after training with physical-cognitive DT focus. Changes in inhibition performance were correlated with changes in DT walking performance with group differences as a function of motor task complexity (with/without hurdling). The study supports the effectiveness of group exercise classes for older individuals to improve gait performance, with physical-cognitive DT training selectively counteracting the age-related decline in a core executive function essential for daily living. PMID:28053985

Effects of Physical-Cognitive Dual Task Training on Executive Function and Gait Performance in Older Adults: A Randomized Controlled Trial.

PubMed

Falbo, S; Condello, G; Capranica, L; Forte, R; Pesce, C

2016-01-01

Physical and cognitive training seem to counteract age-related decline in physical and mental function. Recently, the possibility of integrating cognitive demands into physical training has attracted attention. The purpose of this study was to evaluate the effects of twelve weeks of designed physical-cognitive training on executive cognitive function and gait performance in older adults. Thirty-six healthy, active individuals aged 72.30 ± 5.84 years were assigned to two types of physical training with major focus on physical single task (ST) training ( n = 16) and physical-cognitive dual task (DT) training ( n = 20), respectively. They were tested before and after the intervention for executive function (inhibition, working memory) through Random Number Generation and for gait (walking with/without negotiating hurdles) under both single and dual task (ST, DT) conditions. Gait performance improved in both groups, while inhibitory performance decreased after exercise training with ST focus but tended to increase after training with physical-cognitive DT focus. Changes in inhibition performance were correlated with changes in DT walking performance with group differences as a function of motor task complexity (with/without hurdling). The study supports the effectiveness of group exercise classes for older individuals to improve gait performance, with physical-cognitive DT training selectively counteracting the age-related decline in a core executive function essential for daily living.

Renal histopathology features according to various warm ischemia times in porcine laparoscopic and open surgery model

PubMed Central

Sabbagh, Robert; Chawla, Arun; Tisdale, Britton; Kwan, Kevin; Chatterjee, Suman; Kwiecien, Jacek M.; Kapoor, Anil

2011-01-01

Background Thirty minutes has been considered as the threshold for tolerable warm ischemic time (WIT). Recent reports demonstrate recovery of renal function after longer WIT. We assessed renal histology according to different WIT in a 2-kidney porcine model. Methods Twelve female pigs were randomized to an open or laparoscopic group. Each pig was further randomized within each group to clamping the left renal artery for 5, 15, 30, 45, 60 or 180 minutes. Preclamping left renal biopsies were performed on each pig. The contralateral kidney in each animal was used as an individual control. On postoperative day 14, all animals underwent bilateral nephrectomies. Preclamping left renal biopsies and all renal specimens were evaluated by a blinded veterinary pathologist. Results One pig died in the open group after 180 minutes of clamping. Histopathology did not show any significant changes between the two groups and across clamp times from 5 to 60 minutes. After 180 minutes of laparoscopic clamping, there was evidence of diffuse necrosis. Interpretation Sixty minutes of ischemia did not show any permanent renal damage in both groups. Further studies are needed to verify these findings in humans. A prolonged ischemic time without permanent renal damage would be helpful in partial nephrectomy. Warm ischemic time of 180 minutes exceeded the renal ischemic burden based on histological features. PMID:21470513

Comparison of Ferric Sulfate Combined Mineral Trioxide Aggregate Pulpotomy and Zinc Oxide Eugenol Pulpectomy of Primary Maxillary Incisors: An 18-month Randomized, Controlled Trial.

PubMed

Nguyen, Trang D; Judd, Peter L; Barrett, Edward J; Sidhu, Nicole; Casas, Michael J

2017-01-15

The purpose of this study was to compare outcomes and survival of ferric sulfate with mineral trioxide aggregate (FS+MTA) pulpotomy and root canal therapy (RCT) in carious vital primary maxillary incisors. In this parallel group noninferiority trial, asymptomatic carious vital primary incisors with pulp exposure in healthy 18- to 46-month-olds were allocated randomly to receive FS+MTA pulpotomy or RCT between September 2010 and September 2012. Each incisor was classified into one of the following radiographic outcomes: N (incisor without pathologic change); Po (pathologic change present, follow-up recommended); Px (pathologic change present, extract.) Clinical findings and incisor survival were secondary outcomes. Seventy subjects were enrolled with a total of 172 incisors. Twelve- and 18-month radiographic outcomes demonstrated no statistical difference between FS+MTA pulpotomy and RCT incisors for Px outcomes (P=0.38; odds ratio equals 0.60; 95 percent confidence interval equals 0.19 to 1.89; chi-square test). There was no statistical differences in clinical outcomes for FS+MTA pulpotomy and RCT at 12 and 18 months (P=0.51; Fisher's exact test) or survival for FS+MTA pulpotomy and RCT incisors (P=0.11; log-rank test). Ferric Sulfate with Mineral Trioxide Aggregate (FS+MTA) is an alternative to RCT for vital primary incisors.

Effect of aquatic versus land based exercise programs on physical performance in severely burned patients: a randomized controlled trial

PubMed Central

Zoheiry, Ibrahim M.; Ashem, Haidy N.; Ahmed, Hamada Ahmed Hamada; Abbas, Rami

2017-01-01

[Purpose] To compare the effect of an aquatic-based versus a land-based exercise regimen on the physical performance of severely burned patients. [Subjects and Methods] Forty patients suffering from severe burn (total body surface area more than 30%) were recruited from several outpatient clinics in Greater Cairo. Their ages ranged between 20 to 40 years and were randomly assigned into two equal groups: group (A), which received an aquatic based exercise program, and group (B), which received a land-based exercise program. The exercise program, which took place in 12 consecutive weeks, consisted of flexibility, endurance, and lower and upper body training. Physical performance was assessed using 30 seconds chair stand test, stair climb test, 30 meter fast paced walk test, time up and go test, 6-minute walk test and a VO2max evaluation. [Results] Significantly increase in the 30 second chair stand, 6-minute walk, 30 meter fast paced walk, stair climb, and VO2 max tests and significantly decrease in the time up and go test in group A (aquatic based exercise) compared with group B (a land-based exercise) at the post treatment. [Conclusion] Twelve-week program of an aquatic program yields improvement in both physical performance and VO2 max in patients with severe burns. PMID:29643605

[Prostate cancer diagnostic by saturation randomized biopsy versus rigid targeted biopsy].

PubMed

Defontaines, J; Salomon, L; Champy, C; Cholley, I; Chiaradia, M; de la Taille, A

2017-12-01

Optimal diagram teaming up randomized biopsy (BR) to targeted biopsy (BC) is still missing for the diagnostic of prostate cancer (CP). This study compares diagram of 6, 12 or 18 BR with or without BC rigid. Between January 2014 and May 2016, 120 patients had prostate biopsy BR and BC. Each patient had 18 BR and BC. Results compared sextant (6 BR), standard (12 BR) and saturation (18 BR) protocol with or without the adding of BC for the detection of CP. Rectal examination was normal, mean PSA at 8.99ng/mL and mean volume at 54cm 3 . It was first round for 48% of patients. Forty-four cancers were found by the group 18 BR+BC (control). The detection rate was respectively, for 6, 12 and 18 BR of 61%, 82% and 91%. The add of BC increased this detection of +27% for 6 BR+BC, +13% for 12 BR+BC and +9% for 18 BR+BC. BC found 70% of all CP. Nine percent of CP were missed by BR only. Significant CP (Gleason≥7) diagnostic was the same for 12 BR+BC and 18 BR+BC. The add of BC to BR increase the detection of CP by 10%. Twelve BR+BC is the optimal diagram for the diagnostic of CP finding 95% of CP and 97% of significant CP. 4. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Effect Of Pressure Support Versus Unassisted Breathing Through A Tracheostomy Collar On Weaning Duration In Patients Requiring Prolonged Mechanical Ventilation: A Randomized Trial

PubMed Central

Jubran, Amal; Grant, Brydon J.B.; Duffner, Lisa A.; Collins, Eileen G.; Lanuza, Dorothy M.; Hoffman, Leslie A.; Tobin, Martin J.

2013-01-01

Context Patients requiring prolonged mechanical ventilation (more than 21 days) are commonly weaned at long-term acute care hospitals (LTACHs). The most effective method of weaning such patients has not been investigated. Objective To compare weaning duration with pressure support versus unassisted breathing through a tracheostomy (trach collar) in patients transferred to a LTACH for weaning from prolonged ventilation. Design, Settings, and Participants Between 2000 and 2010, a randomized study was conducted in tracheotomized patients transferred to a single LTACH for weaning from prolonged ventilation. Of 500 patients who underwent a five-day screening procedure, 316 failed and were randomly assigned to wean with pressure support (n=155) or a trach collar (n=161). Six- and twelve-month survival was also determined. Main outcome measure Primary outcome was weaning duration. Secondary outcome was survival at six and twelve months after enrollment. Results Of 316 patients, four were withdrawn and not included in analysis. Of 152 patients in the pressure-support arm, 68 (44.7%) were weaned; 22 (14.5%) died. Of 160 patients in the trach-collar arm, 85 (53.1%) were weaned; 16 (10.0%) died. Median weaning time was shorter with trach collar than with pressure support: 15 [interquartile range, 8–25] versus 19 [12–31] days, p=0.004. The hazard ratio (HR) for successful weaning rate was higher with trach collar than with pressure support (HR, 1.43; 95% confidence interval [CI], 1.03–1.98, p<0.03) after adjusting for baseline clinical covariates. Trach collar achieved faster weaning than did pressure support among subjects who failed the screening procedure at 12–120 hours (HR, 3.33; 95% CI, 1.44–7.70, p<0.01), whereas weaning time was equivalent with the two methods in patients who failed the screening procedure within 0–12 hours. Mortality was equivalent in the pressure-support and trach-collar arms at six months (55.9% versus 51.3%; 4.7 difference, 95% CI −6.4 to 15.7%) and twelve months (66.4% versus 60.0%; 6.5 difference, 95% CI −4.2 to 17.1 %). Conclusion Among patients requiring prolonged mechanical ventilation and treated at a single long-term care facility, unassisted breathing through a tracheostomy, compared with pressure support, resulted in shorter median weaning time, although weaning mode had no effect on survival at 6 and 12 months. PMID:23340588

Comparison of psychological placebo and waiting list control conditions in the assessment of cognitive behavioral therapy for the treatment of generalized anxiety disorder: a meta-analysis

PubMed Central

ZHU, Zhipei; ZHANG, Li; JIANG, Jiangling; LI, Wei; CAO, Xinyi; ZHOU, Zhirui; ZHANG, Tiansong; LI, Chunbo

2014-01-01

Background There is ongoing debate about the efficacy of placebos in the treatment of mental disorders. In randomized control trials (RCTs) about the treatment of generalized anxiety disorder, the administration of a psychological placebo or placement on a waiting list are the two most common control conditions. But there has never been a systematic comparison of the clinical effect of these different strategies. Aim Compare the change in symptom severity among individuals treated with cognitive behavioral therapy, provided a psychological placebo, or placed on a waiting list using data from RCTs on generalized anxiety disorder. Methods The following databases were searched for RCTs on generalized anxiety disorder: PubMed, PsycInfo, EMBASE, The Cochrane Library, CNKI, Chongqing VIP, Wanfang, Chinese Biological Medical Literature Database, and Taiwan Electronic Periodical Services. Studies were selected based on pre-defined inclusion and exclusion criteria and the quality of each included study – based on the risk of bias and the level of evidence – was formally assessed. Meta-analysis was conducted using RevMan5.3 and network meta-analyses comparing the three groups were conducted using R. Results Twelve studies with a combined sample size of 531 were included in the analysis. Compared to either control method (placebo or waiting list), cognitive behavioral therapy was more effective for generalized anxiety disorder. Provision of a psychological placebo was associated with a significantly greater reduction of symptoms than placement on a waiting list. Eight of the studies were classified as ‘high risk of bias’, and the overall level of evidence was classified as ‘moderate’, indicating that further research could change the overall results of the meta-analysis. Conclusions RCTs about the treatment of generalized anxiety disorders are generally of moderate quality; they indicate the superiority of CBT but the results cannot, as yet, be considered robust. There is evidence of a non-negligible treatment effect of psychological placebos used as control conditions in research studies. This effect should be considered when designing and interpreting the results of randomized controlled trials about the effectiveness of psychotherapeutic interventions. PMID:25642106

Influence of zolpidem and sleep inertia on balance and cognition during nighttime awakening: a randomized placebo-controlled trial.

PubMed

Frey, Danielle J; Ortega, Justus D; Wiseman, Courtney; Farley, Claire T; Wright, Kenneth P

2011-01-01

To determine whether sleep inertia (grogginess upon awakening from sleep) with or without zolpidem impairs walking stability and cognition during awakenings from sleep. Three within-subject conditions hypnotic medication (zolpidem), placebo (sleep inertia), and wakefulness control randomized using balanced Latin square design. Sleep laboratory. Twelve older and 13 younger healthy adults. Five milligrams of zolpidem or placebo 10 minutes before scheduled sleep (double-blind: zolpidem or sleep inertia); placebo before sitting in bed awake for 2 hours after their habitual bedtime (single-blind: wakefulness control). Tandem walk on a beam and cognition, measured using computerized performance tasks, approximately 120 minutes after treatment. No participants stepped off the beam on 10 practice trials. Seven of 12 older adults stepped off the beam after taking zolpidem, compared with none after sleep inertia and three after wakefulness control. Fewer young adults stepped off the beam: three after taking zolpidem, one after sleep inertia, and none after wakefulness control. Number needed to harm analyses showed one tandem walk failure for every 1.7 (95% confidence interval (CI)=1.4-2.0) older and 5.5 (95% CI=5.2-5.8) younger adults treated with zolpidem. Cognition was significantly more impaired after zolpidem exposure than with wakefulness control in older and younger participants (working memory: older, -4.3 calculations, 95% CI=-7.0 to -1.7; younger, -12.4 calculations, 95% CI=-18.2 to -6.7; Stroop: older, 76-ms increase (95% CI=13.5-138.4 ms); younger, 126-ms increase, 95% CI=34.7-217.5 ms), whereas sleep inertia significantly impaired cognition in younger but not older participants. Zolpidem produced clinically significant balance and cognitive impairments upon awakening from sleep. Because impaired tandem walk predicts falls and hip fractures and because impaired cognition has important safety implications, use of nonbenzodiazepine hypnotic medications may have greater consequences for health and safety than previously recognized. © 2011, Copyright the Authors. Journal compilation © 2011, The American Geriatrics Society.

Comparison of psychological placebo and waiting list control conditions in the assessment of cognitive behavioral therapy for the treatment of generalized anxiety disorder: a meta-analysis.

PubMed

Zhu, Zhipei; Zhang, Li; Jiang, Jiangling; Li, Wei; Cao, Xinyi; Zhou, Zhirui; Zhang, Tiansong; Li, Chunbo

2014-12-01

There is ongoing debate about the efficacy of placebos in the treatment of mental disorders. In randomized control trials (RCTs) about the treatment of generalized anxiety disorder, the administration of a psychological placebo or placement on a waiting list are the two most common control conditions. But there has never been a systematic comparison of the clinical effect of these different strategies. Compare the change in symptom severity among individuals treated with cognitive behavioral therapy, provided a psychological placebo, or placed on a waiting list using data from RCTs on generalized anxiety disorder. The following databases were searched for RCTs on generalized anxiety disorder: PubMed, PsycInfo, EMBASE, The Cochrane Library, CNKI, Chongqing VIP, Wanfang, Chinese Biological Medical Literature Database, and Taiwan Electronic Periodical Services. Studies were selected based on pre-defined inclusion and exclusion criteria and the quality of each included study - based on the risk of bias and the level of evidence - was formally assessed. Meta-analysis was conducted using RevMan5.3 and network meta-analyses comparing the three groups were conducted using R. Twelve studies with a combined sample size of 531 were included in the analysis. Compared to either control method (placebo or waiting list), cognitive behavioral therapy was more effective for generalized anxiety disorder. Provision of a psychological placebo was associated with a significantly greater reduction of symptoms than placement on a waiting list. Eight of the studies were classified as 'high risk of bias', and the overall level of evidence was classified as 'moderate', indicating that further research could change the overall results of the meta-analysis. RCTs about the treatment of generalized anxiety disorders are generally of moderate quality; they indicate the superiority of CBT but the results cannot, as yet, be considered robust. There is evidence of a non-negligible treatment effect of psychological placebos used as control conditions in research studies. This effect should be considered when designing and interpreting the results of randomized controlled trials about the effectiveness of psychotherapeutic interventions.

"Open lung ventilation optimizes pulmonary function during lung surgery".

PubMed

Downs, John B; Robinson, Lary A; Steighner, Michael L; Thrush, David; Reich, Richard R; Räsänen, Jukka O

2014-12-01

We evaluated an "open lung" ventilation (OV) strategy using low tidal volumes, low respiratory rate, low FiO2, and high continuous positive airway pressure in patients undergoing major lung resections. In this phase I pilot study, twelve consecutive patients were anesthetized using conventional ventilator settings (CV) and then OV strategy during which oxygenation and lung compliance were noted. Subsequently, a lung resection was performed. Data were collected during both modes of ventilation in each patient, with each patient acting as his own control. The postoperative course was monitored for complications. Twelve patients underwent open thoracotomies for seven lobectomies and five segmentectomies. The OV strategy provided consistent one-lung anesthesia and improved static compliance (40 ± 7 versus 25 ± 4 mL/cm H2O, P = 0.002) with airway pressures similar to CV. Postresection oxygenation (SpO2/FiO2) was better during OV (433 ± 11 versus 386 ± 15, P = 0.008). All postoperative chest x-rays were free of atelectasis or infiltrates. No patient required supplemental oxygen at any time postoperatively or on discharge. The mean hospital stay was 4 ± 1 d. There were no complications or mortality. The OV strategy, previously shown to have benefits during mechanical ventilation of patients with respiratory failure, proved safe and effective in lung resection patients. Because postoperative pulmonary complications may be directly attributable to the anesthetic management, adopting an OV strategy that optimizes lung mechanics and gas exchange may help reduce postoperative problems and improve overall surgical results. A randomized trial is planned to ascertain whether this technique will reduce postoperative pulmonary complications. Copyright © 2014 Elsevier Inc. All rights reserved.

Do bioclimate variables improve performance of climate envelope models?

USGS Publications Warehouse

Watling, James I.; Romañach, Stephanie S.; Bucklin, David N.; Speroterra, Carolina; Brandt, Laura A.; Pearlstine, Leonard G.; Mazzotti, Frank J.

2012-01-01

Climate envelope models are widely used to forecast potential effects of climate change on species distributions. A key issue in climate envelope modeling is the selection of predictor variables that most directly influence species. To determine whether model performance and spatial predictions were related to the selection of predictor variables, we compared models using bioclimate variables with models constructed from monthly climate data for twelve terrestrial vertebrate species in the southeastern USA using two different algorithms (random forests or generalized linear models), and two model selection techniques (using uncorrelated predictors or a subset of user-defined biologically relevant predictor variables). There were no differences in performance between models created with bioclimate or monthly variables, but one metric of model performance was significantly greater using the random forest algorithm compared with generalized linear models. Spatial predictions between maps using bioclimate and monthly variables were very consistent using the random forest algorithm with uncorrelated predictors, whereas we observed greater variability in predictions using generalized linear models.

The impact of the Virtual Ophthalmology Clinic on medical students' learning: a randomised controlled trial

PubMed Central

Succar, T; Zebington, G; Billson, F; Byth, K; Barrie, S; McCluskey, P; Grigg, J

2013-01-01

Aim The Virtual Ophthalmology Clinic (VOC) is an interactive web-based teaching module, with special emphasis on history taking and clinical reasoning skills. The purpose of this study was to determine the impact of VOC on medical students' learning. Methods A randomised controlled trial (RCT) was conducted with medical students from the University of Sydney (n=188) who were randomly assigned into either an experimental (n=93) or a control group (n=95). A pre- and post-test and student satisfaction questionnaire were administered. Twelve months later a follow-up test was conducted to determine the long-term retention rate of graduates. Results There was a statistically significant (P<0.001) within-subject improvement pre- to post rotation in the number of correctly answered questions for both the control and experimental groups (mean improvement for control 10%, 95% CI 1.3–2.6, and for experimental 17.5%, 95% CI 3.0–4.0). The improvement was significantly greater in the experimental group (mean difference in improvement between groups 7.5%, 95% CI 0.8–2.3, P<0.001). At 12 months follow-up testing, the experimental group scored on average 1.6 (8%) (95%CI 0.4 to 2.7, P=0.007) higher than the controls. Conclusion On the basis of a statistically significant improvement in academic performance and highly positive student feedback, the implementation of VOC may provide a means to address challenges to ophthalmic learning outcomes in an already crowded medical curriculum. PMID:23867718

Influence of risperidone on balance control in young healthy individuals.

PubMed

Corbeil, Philippe; Rodrigue, Julien; Simoneau, Martin; Cohen, Henri; Pourcher, Emmanuelle

2012-07-01

It has previously been shown that impairment of postural stability is a side effect of typical antipsychotic drugs, which are largely administered to control psychosis and behavioral symptoms in elderly patients. Surprisingly, no study has yet addressed this problem with second-generation antipsychotics. The objective of this study was to determine the extent to which risperidone at low doses altered balance control in healthy participants. Twelve healthy young adults received, following a randomized double-blind crossover design, a single oral dose of placebo, 1 and 3 mg of risperidone on separate days at least 14 days apart. Evaluation of extrapyramidal symptoms using the Extrapyramidal Symptom Rating Scale-abbreviated scoring form (ESRS-A) and measures of postural sway using a force platform were assessed over 9 h following drug ingestion. There is a significant increase in the postural stability item of the ESRS-A parkinsonism subscale at 3 and 6 h following 3 mg of risperidone only when compared to placebo. With regard to balance control, body sway measures were increased at 1 mg of risperidone but more pronounced at 3 mg. The peak effects were observed at 3 h after administration of the drug and had not completely returned to baseline after 9 h. Risperidone administered at low doses did not elicit clinically detectable EPS but had significant effects on balance control. A dose-response effect on impairment of balance was observed that followed the expected time course of the drug pharmacokinetics. These results are likely to apply to older or demented individuals who have pre-existing balance control deficit.

Anxiety management training for anxiety states: positive compared with negative self-statements.

PubMed

Ramm, E; Marks, I M; Yuksel, S; Stern, R S

1982-04-01

Twelve patients complaining of chronic free-floating anxiety, usually also with panic attacks, were assigned at random to treatment by six hour-long sessions of anxiety-management training, either with positive or with negative self-statements, given over six weeks. Patients in both treatment conditions improved, with a small trend favouring positive over negative self-instruction, especially at follow-up. It is unclear how much self-instruction, rather than therapeutic attention or mere passage of time, accounted for the bulk of the modest improvement obtained.

Karyotype analysis of anuran trypanosomes by pulsed-field gradient gel electrophoresis.

PubMed

Lun, Z R; Desser, S S

1995-12-01

The chromosomes of 12 species and isolates of anuran trypanosomes were investigated by pulsed-field gradient gel electrophoresis. Twelve to 16 chromosomes ranging from 0.45 to 2.2 megabase pairs were found in each of these trypanosomes. Minichromosomes were not observed in any of the examined isolates. Results indicate that different species of anuran trypanosomes display distinct karyotype patterns, and that isolates from the same region are similar. Our findings also reveal that most chromosome profiles of these trypanosomes are in accordance with isoenzyme and random amplified polymorphic DNA analysis data.

[Children with Multiple Risk Factor Exposition Benefit from the German "Strengthening Families Program"].

PubMed

Bröning, Sonja; Sack, Peter-Michael; Thomsen, Monika; Thomasius, Rainer

2016-09-01

Children with Multiple Risk Factor Exposition Benefit from the German "Strengthening Families Program" The German adaptation of the substance use-preventive family-based Strengthening Families Program 10-14 (SFP, Iowa version) was evaluated in a longitudinal two-year follow-up trial. Participants were N = 292 children with a mean age of twelve years at baseline, and N = 292 parents. We employed a multi-centric, randomized-controlled, two-armed (SFP vs. minimal control condition) study design. Following a "risk moderation hypothesis", we assumed that children with an elevated risk-exposition R(+) would benefit more than children with a low risk-exposition R(-) irrespective of the preventive intervention, and that R(+) under SFP would benefit more than R(+) under the minimal control condition. "Risk-exposition" was measured in correspondence with the Communities That Care Youth Survey-questionnaire. A total of 28 % of children were classified with an elevated risk level. Children's reports confirmed our hypothesis: R(+) report a total of eleven improvements, four of these being significantly more distinct than in the other groups (Anxiety-Depressivity, Punitive Parenting of mother, Punitive Parenting of father, Unbalanced family functioning). In three measures an improvement appears solely in R(+) under SFP (Satisfaction with family functioning, School Attachment and Peer Relationship Quality, Quality of Life). Parents' reports showed a similar tendency, but were less pronounced.

Treatment effects for dysphagia in Parkinson's disease: a systematic review.

PubMed

van Hooren, M R A; Baijens, L W J; Voskuilen, S; Oosterloo, M; Kremer, B

2014-08-01

Dysphagia remains a common problem in Parkinson's disease (PD). Previous systematic reviews on therapy effects for oropharyngeal dysphagia in PD have shown a lack of evidence. In the past 5 years several placebo or sham-controlled trials with varying results have been published. The aim of this systematic literature review is to summarize and qualitatively analyze the published studies on this matter. Studies published up to December 2013 were found via a systematic comprehensive electronic database search using PubMed, Embase, and The Cochrane Library. Two reviewers independently assessed the studies using strict inclusion criteria. Twelve studies were included and qualitatively analyzed using critical appraisal items. The review includes rehabilitative (exercises, electrical stimulation, bolus modification etc.) and pharmacologic treatment. Some well-designed controlled trials were included. However, none of the included studies fulfilled all criteria for external and internal validity. A meta-analysis was not carried out as most of the studies were not of sufficient quality to warrant doing so. Expiratory Muscle Strength Training (EMST) and Video-Assisted Swallowing Therapy (VAST) may be effective dysphagia treatments solely or in addition to dopaminergic therapy for PD. However, these preliminary results warrant further investigation concerning their clinical applicability, and further research should be based on randomized sham-controlled trials to determine the effectiveness and long-term effects of different therapies for dysphagia in PD. Copyright © 2014 Elsevier Ltd. All rights reserved.

Influence of cold-water immersion on limb blood flow after resistance exercise.

PubMed

Mawhinney, Chris; Jones, Helen; Low, David A; Green, Daniel J; Howatson, Glyn; Gregson, Warren

2017-06-01

This study determined the influence of cold (8°C) and cool (22°C) water immersion on lower limb and cutaneous blood flow following resistance exercise. Twelve males completed 4 sets of 10-repetition maximum squat exercise and were then immersed, semi-reclined, into 8°C or 22°C water for 10-min, or rested in a seated position (control) in a randomized order on different days. Rectal and thigh skin temperature, muscle temperature, thigh and calf skin blood flow and superficial femoral artery blood flow were measured before and after immersion. Indices of vascular conductance were calculated (flux and blood flow/mean arterial pressure). The colder water reduced thigh skin temperature and deep muscle temperature to the greatest extent (P < .001). Reductions in rectal temperature were similar (0.2-0.4°C) in all three trials (P = .69). Femoral artery conductance was similar after immersion in both cooling conditions, with both conditions significantly lower (55%) than the control post-immersion (P < .01). Similarly, there was greater thigh and calf cutaneous vasoconstriction (40-50%) after immersion in both cooling conditions, relative to the control (P < .01), with no difference between cooling conditions. These findings suggest that cold and cool water similarly reduce femoral artery and cutaneous blood flow responses but not muscle temperature following resistance exercise.

Evaluation of the Effect of Plasma Rich in Growth Factors (PRGF) on Bone Regeneration.

PubMed

Paknejad, M; Shayesteh, Y Soleymani; Yaghobee, S; Shariat, S; Dehghan, M; Motahari, P

2012-01-01

Reconstruction methods are an essential prerequisite for functional rehabilitation of the stomatognathic system. Plasma rich in growth factors (PRGF) offers a new and potentially useful adjunct to bone substitute materials in bone reconstructive surgery. This study was carried out to investigate the influence of PRGF and fibrin membrane on regeneration of bony defects with and without deproteinized bovine bone mineral (DBBM) on rabbit calvaria. Twelve New Zealand white rabbits were included in this randomized, blinded, prospective study. Four equal 3.3×6.6 mm cranial bone defects were created and immediately grafted with DBBM, PRGF+DBBM, PRGF+fibrin membrane and no treatment as control. The defects were evaluated with histologic and histomorphometric analysis performed 4 and 8 weeks later. Adding PRGF to DBBM led to increased bone formation as compared with the control group in 4- and 8-week intervals. In DBBM and PRGF+fibrin membrane samples, no significant increase was seen compared to the control group. There was also a significant increase in the rate of biodegradation of DBBM particles with the addition of PRGF in the 8-week interval. Neither noticeable foreign body reaction nor any severe inflammation was seen in each of the specimens evaluated. Under the limitation of this study, adding PRGF to DBBM enhanced osteogenesis in rabbit calvarias. Applying autologous fibrin membrane in the defects was not helpful.

Evaluation of the Effect of Plasma Rich in Growth Factors (PRGF) on Bone Regeneration

PubMed Central

Paknejad, M.; Shayesteh, Y. Soleymani; Yaghobee, S.; Shariat, S.; Dehghan, M.; Motahari, P.

2012-01-01

Objective: Reconstruction methods are an essential prerequisite for functional rehabilitation of the stomatognathic system. Plasma rich in growth factors (PRGF) offers a new and potentially useful adjunct to bone substitute materials in bone reconstructive surgery. This study was carried out to investigate the influence of PRGF and fibrin membrane on regeneration of bony defects with and without deproteinized bovine bone mineral (DBBM) on rabbit calvaria. Materials and Methods: Twelve New Zealand white rabbits were included in this randomized, blinded, prospective study. Four equal 3.3×6.6 mm cranial bone defects were created and immediately grafted with DBBM, PRGF+DBBM, PRGF+fibrin membrane and no treatment as control. The defects were evaluated with histologic and histomorphometric analysis performed 4 and 8 weeks later. Results: Adding PRGF to DBBM led to increased bone formation as compared with the control group in 4- and 8-week intervals. In DBBM and PRGF+fibrin membrane samples, no significant increase was seen compared to the control group. There was also a significant increase in the rate of biodegradation of DBBM particles with the addition of PRGF in the 8-week interval. Neither noticeable foreign body reaction nor any severe inflammation was seen in each of the specimens evaluated. Conclusion: Under the limitation of this study, adding PRGF to DBBM enhanced osteogenesis in rabbit calvarias. Applying autologous fibrin membrane in the defects was not helpful. PMID:22924103

Effect of oral administration of carprofen on intraocular pressure in normal dogs.

PubMed

Meekins, J M; Overton, T L; Rankin, A J; Roush, J K

2016-08-01

The aim of this study was to determine the effect of oral administration of carprofen on intraocular pressure in normal dogs. Twelve young adult beagle dogs were randomly assigned to treatment (n = 6) or control (n = 6) groups. After an 11-day acclimation period, the treatment group received approximately 2.2 mg/kg carprofen per os every 12 h for 7 days, and the control group received a placebo gel capsule containing no drug per os every 12 h for 7 days. Intraocular pressure (IOP) was measured by a rebound tonometer at three time points per day (8 am, 2 pm, and 8 pm) during the acclimation (days 1-11) and treatment (days 12-18) phases and for 48 h (days 19-20) after the completion of treatment. There was no statistically significant change in IOP for either eye in the dogs receiving oral carprofen during the treatment phase (days 12-18). After day 4, no significant daily IOP changes were seen in control group dogs. Carprofen administered orally every 12 h for 7 days had no effect on IOP in normal beagle dogs. An acclimation period to frequent IOP measurements of at least 5 days is necessary to establish baseline IOP values and minimize possible anxiety-related effects on IOP measurements. © 2016 John Wiley & Sons Ltd.

Placebo-controlled pilot trial testing dose titration and intravenous, intramuscular and subcutaneous routes for ketamine in depression.

PubMed

Loo, C K; Gálvez, V; O'Keefe, E; Mitchell, P B; Hadzi-Pavlovic, D; Leyden, J; Harper, S; Somogyi, A A; Lai, R; Weickert, C S; Glue, P

2016-07-01

This pilot study assessed the feasibility, efficacy and safety of an individual dose-titration approach, and of the intravenous (IV), intramuscular (IM) and subcutaneous (SC) routes for treating depression with ketamine. Fifteen treatment-refractory depressed participants received ketamine or midazolam (control treatment) in a multiple crossover, double-blind study. Ketamine was administered by IV (n = 4), IM (n = 5) or SC (n = 6) injection. Dose titration commenced at 0.1 mg/kg, increasing by 0.1 mg/kg up to 0.5 mg/kg, given in separate treatment sessions separated by ≥1 week, with one placebo control treatment randomly inserted. Mood, psychotomimetic and hemodynamic effects were assessed and plasma ketamine concentrations assayed. Twelve participants achieved response and remission criteria, achieved at doses as low as 0.1 mg/kg. All three routes of administration resulted in comparable antidepressant effects. Fewest adverse effects were noted with the SC route. Antidepressant response, adverse effects and ketamine concentrations were dose-related. Antidepressant response occurred at a range of doses and at <0.5 mg/kg. The dose-titration approach is a practical method for optimizing the efficacy - side-effects trade-off on an individual patient basis. This pilot study provides preliminary evidence for SC injection as a practical, feasible and efficacious treatment approach. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Effect of Anatomical Customization of the Fiber Post on the Bond Strength of a Self-Adhesive Resin Cement

PubMed Central

Rocha, Adricyla Teixeira; Vasconcelos, Ana Júlia de Carvalho; Nunes Carvalho, Ceci

2017-01-01

Aim The aim of the study was to evaluate, by means of the push-out test, the effect of the anatomical customization of the fiber post on the bond strength of a self-adhesive resin cement. Methods Twelve endodontically treated, human, upper central incisors were randomly divided into two groups (n = 6): control (glass fiber posts cemented with Relyx® U200) and customized (glass fiber posts anatomically customized with translucent composite resin cemented with Relyx U200). The roots were sectioned into three slices, cervical, middle, and apical, and photographed with a digital camera attached to a stereomicroscopic loupe. The images were analyzed by software, for evaluation of the cement line. The slices were subsequently submitted to the push-out test until the post had completely extruded, and the fracture mode was analyzed with a stereomicroscopic loupe. Results The results showed significant differences between the groups in the different root thirds in relation to the area occupied by air bubbles (p < 0.05). Bond strength, when all the thirds are considered, was 8.77 ± 4.89 MPa for the control group and 16.96 ± 4.85 MPa for the customized group. Conclusion The customized group showed greater bond resistance than the control group and a more uniform cement layer. PMID:28785281

Anthropometric and physiological profiles of active blind Malaysian males.

PubMed

Singh, R; Singh, H J

1993-12-01

Cardiopulmonary capacities of twelve adults (aged between 14 to 44 years) with varying degrees of blindness engaged in regular recreational activities were compared with twelve age-matched normal sighted healthy males (control group) who were also involved in regular recreational activities. Maximum oxygen consumption (VO2max) was measured directly during exhaustive exercise test on a cycle ergometer. Forced vital capacity, leg strength and power were determined by spirometry, standing long jump and vertical jump respectively. No significant differences in VO2max, forced vital capacity and leg strength and power were observed between the blind and the control groups. No anthropometric differences were evident between the two groups. The results show therefore that the visually handicapped who are active can have a similar level of physical fitness, lung function and explosive leg strength as those of their active sighted counterparts.

One Year Follow-up of Outcomes from the Randomized Clinical Trial of the Building on Family Strengths Program.

PubMed

Churchill, Shervin S; Kieckhefer, Gail M

2018-06-01

Objectives Test the 12-month efficacy of an inclusive non-diagnosis-specific, parent education program with seven in-person sessions. Methods Parents of 110 children, 2-11 years old, with a variety of special health care conditions, were recruited to participate in a randomized clinical trial. At twelve months data from 104 parents were available for longitudinal analysis. Linear mixed models, with the interaction term of group by time, were used to assess the efficacy of the intervention over 12 months using data from 3 time points: baseline, 6 and 12 months. The outcome measures were self-efficacy, parent and child shared management of chronic condition, coping skills, parental depressive symptoms and quality of life. Results All of the outcomes improved within the intervention group over 12 months. Self-efficacy was the strongest outcome which remained significantly different from the control group 12 months post intervention, without any statistical adjustment (p = 0.045). The coefficient of the interaction term for study group (intervention or control) by time, quantifying the intervention effect, was statistically significant for four of five pre-specified study outcomes, favorably so toward the intervention group (p < 0.05, with the 5th outcome, parental depression, p = 0.052). Conclusions for Practice The Building on Family Strengths intervention was efficacious in improving self-efficacy, shared management, coping skills, and quality of life and decreasing depressive symptoms in parents, in particular for parents who were most impacted by the lack of these strengths and skills at baseline. These results are encouraging and future studies to investigate the efficacy of this intervention in an Internet-based setting or other modalities are encouraged.

Adjuvant Treatment with Yupingfeng Formula for Recurrent Respiratory Tract Infections in Children: A Meta-analysis of Randomized Controlled Trials.

PubMed

Song, Tao; Hou, Xiaoli; Yu, Xiaohui; Wang, Zhen; Wang, Ruiren; Li, Yanling; Hu, Dan; Wang, Xiaohong; Xiao, Zhengzheng; Sui, Yong; Zhu, Chunhong; Wang, Jing

2016-07-01

This meta-analysis aimed to evaluate the immunomodulating function of Yupingfeng Formula (YPFF) in children with recurrent respiratory tract infections (RRTIs). The PubMed, EMBASE, Cochrane Library, CNKI and WanFang databases were searched for randomized controlled trials comparing with and without YPFF for RRTIs in children. Twelve trials with 1236 patients were identified. Adjuvant treatment with YPFF significantly increased serum levels of IgA (weighted mean difference [WMD] 0.33 mg/mL; 95% confidence interval [CI] 0.20 to 0.45), IgG (WMD 1.36 mg/mL; 95% CI 1.06 to 1.65), IgM (WMD 0.16 mg/mL; 95% CI 0.02 to 0.31), and CD3(+) T-lymphocytes (WMD 10.16%; 95% CI 4.62 to 15.69) but not CD4(+) T-lymphocytes (WMD 3.16%; 95% CI -0.27 to 6.59) and CD8(+) T-lymphocytes (WMD -0.84%; 95% CI -2.50 to 0.81). YPFF also reduced the frequency of RRTIs (WMD -3.80 times; 95% CI -4.86 to -2.74) and increased total effective rates of symptom improvement (risk ratio: 1.44; 95% CI 1.19 to 1.75). Adjuvant treatment with YPFF could improve total clinical effective rate and decrease the frequency of respiratory tract infections in children with RRTIs. The beneficial effects of YPFF may be correlated to its immunomodulating action. More well-designed trials with larger sample sizes are needed to evaluate its efficacy and safety. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

The effects of health care-based violence intervention programs on injury recidivism and costs: A systematic review.

PubMed

Strong, Bethany L; Shipper, Andrea G; Downton, Katherine D; Lane, Wendy G

2016-11-01

Youth violence affects thousands annually, with homicide being the third leading cause of death for those aged 10 to 24 years. This systematic review aims to evaluate the published evidence for the effects of health care-based violence intervention programs (VIPs), which focus on reducing recurrent presentations for injury due to youth violence ("recidivism"). Health literature databases were searched. Studies were retained if peer reviewed and if programs were health care based, focused on intentional injury, addressed secondary or tertiary prevention (i.e., preventing recidivism and reducing complications), included participants aged 14 to 25 years, had greater than 1-month follow-up, and evaluated outcomes. Studies of child and sexual abuse and workplace, intimate partner, and self-inflicted violence were excluded. Extracted data subject to qualitative analysis included enrollment and retention, duration of follow-up, services provided, statistical analysis, and primary and intermediate outcomes. Of the 2,144 citations identified, 22 studies were included in the final sample. Twelve studies were randomized controlled trials representing eight VIPs. Injury recidivism was assessed in six (75%) of eight programs with a significant reduction in one (17%) of six programs. Of the randomized controlled trials showing no difference in recidivism, all were either underpowered or did not include a power analysis. Two observational studies also showed significant reduction in recidivism. Significant intermediate outcomes included increased service use, attitude change, and decreases in violence-related behavior. Reductions in injury recidivism led to reductions in health care and criminal justice system costs. Three studies showing reduced injury recidivism and several studies showing positive intermediate outcomes identify VIPs as a promising practice. Many studies were limited by poor methodological quality, including high losses to follow-up. Systematic review, level III.

Internet-based prevention for alcohol and cannabis use: final results of the Climate Schools course.

PubMed

Newton, Nicola C; Teesson, Maree; Vogl, Laura E; Andrews, Gavin

2010-04-01

To establish the long-term efficacy of a universal internet-based alcohol and cannabis prevention programme in schools. A cluster-randomized controlled trial was conducted to assess the effectiveness of the Climate Schools: Alcohol and Cannabis Course. The evidence-based course, aimed at reducing alcohol and cannabis use, is facilitated by the internet and consists of 12 novel and curriculum consistent lessons delivered over 6 months. A total of 764 year 8 students (13 years) from 10 Australian secondary schools were allocated randomly to the internet-based prevention programme (n = 397, five schools), or to their usual health classes (n = 367, five schools). Participants were assessed at baseline, immediately post, and 6 and 12 months following completion of the intervention, on measures of alcohol and cannabis knowledge, attitudes, use and related harms. This paper reports the final results of the intervention trial, 12 months following the completion of the Climate Schools: Alcohol and Cannabis Course. The effectiveness of the course 6 months following the intervention has been reported previously. At the 12-month follow-up, compared to the control group, students in the intervention group showed significant improvements in alcohol and cannabis knowledge, a reduction in average weekly alcohol consumption and a reduction in frequency of drinking to excess. No differences between groups were found on alcohol expectancies, cannabis attitudes or alcohol- and cannabis-related harms. The course was found to be acceptable by teachers and students as a means of delivering drug education in schools. Internet-based prevention programs for school-age children can improve student's knowledge about alcohol and cannabis, and may also reduce alcohol use twelve months after completion.

Study protocol: effects of school gardens on children's physical activity.

PubMed

Wells, Nancy M; Myers, Beth M; Henderson, Charles R

2014-01-01

Childhood obesity is an epidemic. Strategies are needed to promote children's healthy habits related to diet and physical activity. School gardens have the potential to bolster children's physical activity and reduce time spent in sedentary activity; however little research has examined the effect of gardens on children's physical activity. This randomized controlled trial (RCT) examines the effect of school gardens on children's overall physical activity and sedentary behavior; and on children's physical activity during the school day. In addition, physical activity levels and postures are compared using direct observation, outdoors, in the garden and indoors, in the classroom. Twelve New York State schools are randomly assigned to receive the school garden intervention or to serve in the wait-list control group that receives gardens and lessons at the end of the study. The intervention consists of a raised bed garden; access to a curriculum focused on nutrition, horticulture, and plant science and including activities and snack suggestions; resources for the school including information about food safety in the garden and related topics; a garden implementation guide provided guidance regarding planning, planting and maintaining the garden throughout the year; gardening during the summer; engaging volunteers; building community capacity, and sustaining the program. Data are collected at baseline and 3 post-intervention follow-up waves at 6, 12, and 18 months. Physical activity (PA) "usually" and "yesterday" is measured using surveys at each wave. In addition, at-school PA is measured using accelerometry for 3 days at each wave. Direct observation (PARAGON) is used to compare PA during an indoor classroom lesson versus outdoor, garden-based lesson. Results of this study will provide insight regarding the potential for school gardens to increase children's physical activity and decrease sedentary behaviors. Clinicaltrial.gov # NCT02148315.

Impact of Proactive Nurse Participation in ICU Family Conferences: A Mixed-Method Study.

PubMed

Garrouste-Orgeas, Maité; Max, Adeline; Lerin, Talia; Grégoire, Charles; Ruckly, Stéphane; Kloeckner, Martin; Brochon, Sandie; Pichot, Emmanuelle; Simons, Clara; El-Mhadri, Myriame; Bruel, Cédric; Philippart, François; Fournier, Julien; Tiercelet, Kelly; Timsit, Jean-François; Misset, Benoit

2016-06-01

To investigate family perceptions of having a nurse participating in family conferences and to assess the psychologic well being of the same families after ICU discharge. Mixed-method design with a qualitative study embedded in a single-center randomized study. Twelve-bed medical-surgical ICU in a 460-bed tertiary hospital. One family member for each consecutive patient who received more than 48 hours of mechanical ventilation in the ICU. Planned proactive participation of a nurse in family conferences led by a physician. In the control group, conferences were led by a physician without a nurse. Of the 172 eligible family members, 100 (60.2%) were randomized; among them, 88 underwent semistructured interviews at ICU discharge and 86 completed the Peritraumatic Dissociative Experiences Questionnaire at ICU discharge and then the Hospital Anxiety Depression Questionnaire and the Impact of Event Scale (for posttraumatic stress-related symptoms) 3 months later. The intervention and control groups were not significantly different regarding the prevalence of posttraumatic stress-related symptoms (52.3 vs 50%, respectively; p = 0.83). Anxiety and depression subscale scores were significantly lower in the intervention group. The qualitative data indicated that the families valued the principle of the conference itself. Perceptions of nurse participation clustered into four main themes: trust that ICU teamwork was effective (50/88; 56.8%), trust that care was centered on the patient (33/88; 37.5%), trust in effective dissemination of information (15/88; 17%), and trust that every effort was made to relieve anxiety in family members (12/88; 13.6%). Families valued the conferences themselves and valued the proactive participation of a nurse. These positive perceptions were associated with significant anxiety or depression subscale scores but not with changes in posttraumatic stress-related symptoms.

Acetyl-L-Carnitine Supplementation and the Treatment of Depressive Symptoms: A Systematic Review and Meta-Analysis.

PubMed

Veronese, Nicola; Stubbs, Brendon; Solmi, Marco; Ajnakina, Olesya; Carvalho, Andre F; Maggi, Stefania

Deficiency of acetyl-L-carnitine (ALC) seems to play a role in the risk of developing depression, indicating a dysregulation of fatty acid transport across the inner membrane of mitochondria. However, data about ALC supplementation in humans are limited. We thus conducted a systematic review and meta-analysis investigating the effect of ALC on depressive symptoms across randomized controlled trials (RCTs). A literature search in major databases, without language restriction, was undertaken from inception until 30 December 2016. Eligible studies were RCTs of ALC alone or in combination with antidepressant medications, with a control group taking placebo/no intervention or antidepressants. Standardized mean differences (SMDs) and 95% confidence intervals (CIs) were used for summarizing outcomes with a random-effect model. Twelve RCTs (11 of which were ALC monotherapy) with a total of 791 participants (mean age = 54 years, % female = 65%) were included. Pooled data across nine RCTs (231 treated with ALC versus 216 treated with placebo and 20 no intervention) showed that ALC significantly reduced depressive symptoms (SMD = -1.10, 95% CI = -1.65 to -0.56, I = 86%). In three RCTs comparing ALC versus antidepressants (162 for each group), ALC demonstrated similar effectiveness compared with established antidepressants in reducing depressive symptoms (SMD = 0.06, 95% CI = -0.22 to 0.34, I = 31%). In these latter RCTs, the incidence of adverse effects was significantly lower in the ALC group than in the antidepressant group. Subgroup analyses suggested that ALC was most efficacious in older adults. ALC supplementation significantly decreases depressive symptoms compared with placebo/no intervention, while offering a comparable effect with that of established antidepressant agents with fewer adverse effects. Future large scale trials are required to confirm/refute these findings.

Does adding a dietician to the liaison team after discharge of geriatric patients improve nutritional outcome: a randomised controlled trial.

PubMed

Beck, A; Andersen, U T; Leedo, E; Jensen, L L; Martins, K; Quvang, M; Rask, K Ø; Vedelspang, A; Rønholt, F

2015-11-01

The objective was to test whether adding a dietician to a discharge Liaison-Team after discharge of geriatric patients improves nutritional status, muscle strength and patient relevant outcomes. Twelve-week randomized controlled trial. Geriatric patients (70 + years and at nutritional risk) at discharge. Participants were randomly allocated to receive discharge Liaison-Team vs. discharge Liaison-Team in cooperation with a dietician. The dietician performed a total of three home visits with the aim of developing and implementing an individual nutritional care plan. The first visit took place at the day of discharge together with the discharge Liaison-Team while the remaining visits took place approximately three and eight weeks after discharge and were performed by a dietician alone. Nutritional status (weight, and dietary intake), muscle strength (hand grip strength, chair-stand), functional status (mobility, and activities of daily living), quality of life, use of social services, re-/hospitalization and mortality. Seventy-one patients were included (34 in the intervention group), and 63 (89%) completed the second data collection after 12 weeks (31 in the intervention group). Odds ratios for hospitalization and mortality 6 months after discharge were 0.367 (0.129; 1.042) and 0.323 (0.060; 1.724). Nutritional status improved and some positive tendencies in favour of the intervention group were observed for patient relevant outcomes, i.e. activities of daily living, and quality of life. Almost 100% of the intervention group received three home visits by a dietician. Adding a dietician to the discharge Liaison-Team after discharge of geriatric patients can improve nutritional status and may reduce the number of times hospitalized within 6 months. A larger study is necessary to see a significant effect on other patient relevant outcomes. © The Author(s) 2014.

Motivational characteristics and resistance training in older adults: a randomized controlled trial and 1-year follow-up.

PubMed

Kekäläinen, Tiia; Kokko, Katja; Tammelin, Tuija; Sipilä, Sarianna; Walker, Simon

2018-06-07

The aim of this study was to investigate the effects of a nine-month supervised resistance training intervention on motivational and volitional characteristics related to exercise, and whether the absolute level and/or intervention-induced change in these characteristics predict self-directed continuation of resistance training one year after the intervention. Community-dwelling older adults aged 65-75, who did not fulfill physical activity recommendations, were randomized into resistance training intervention groups: training once- (n=26), twice- (n=27), three-times-a-week (n=28) or non-training control group (n=25). Training groups participated in supervised resistance training for nine months: during months 1-3 all groups trained twice-a-week and then with allocated frequencies during months 4-9. Exercise-related motivation, self-efficacy and planning were measured with questionnaires at baseline, month-3 and month-9. The continuance of resistance training was determined by interviews six and twelve months after the end of the intervention. The intervention improved action and coping planning as well as intrinsic motivation (group×time p<.05). During one-year follow-up, 54% of participants did not continue self-directed regular resistance training, 22% continued regular resistance training once-a-week and 24% twice-a-week. Increases in exercise self-efficacy and intrinsic motivation related to training during the intervention predicted continuation of resistance training twice-a-week. Resistance training improved exercise-related motivational and volitional characteristics in older adults. These improvements were linked to continuing resistance training one year after the supervised intervention. The role of these characteristics should be taken into account when promoting long-term resistance training participation among older adults. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Culturally Targeted Strategies for Diabetes Prevention in Minority Populations: A Systematic Review and Framework

PubMed Central

Lagisetty, Pooja A.; Priyadarshini, Shubadra; Terrell, Stephanie; Hamati, Mary; Landgraf, Jessica; Chopra, Vineet; Heisler, Michele

2017-01-01

Purpose The purpose of this study is to (a) assess the effectiveness of culturally tailored diabetes prevention interventions in minority populations and (b) develop a novel framework to characterize four key domains of culturally tailored interventions. Prevention strategies specifically tailored to the culture of ethnic minority patients may help reduce the incidence of diabetes. Methods We searched PubMed, EMBASE, and CINAHL for English-language, randomized controlled trials (RCTs) or quasi-experimental (QE) trials testing culturally tailored interventions to prevent diabetes in minority populations. Two reviewers independently extracted data and assessed risk of bias. Inductive thematic analysis was used to develop a framework with four domains (FiLLM: Facilitating [i.e., delivering] Interventions through Language, Location and Message). The framework was used to assess the overall effectiveness of culturally tailored interventions. Results Thirty-four trials met eligibility criteria. Twelve studies were randomized controlled trials, and 22 were quasi-experimental trials. Twenty-five out of 34 studies (74%) that used cultural tailoring demonstrated significantly improved Hemoglobin A1C, fasting glucose, and/or weight loss. Of the 25 successful interventions, 21 (84%) incorporated at least three culturally targeted domains. Seven studies used all four domains and were all successful. The least utilized domain was delivery (4/34) of the intervention’s key educational message. Conclusions Culturally tailoring interventions across the four domains of facilitators, language, location, and messaging can be effective in improving risk factors for progression to diabetes among ethnic minority groups. Future studies should evaluate how specific tailoring approaches work compared to usual care as well as comparative effectiveness of each tailoring domain. Registration (PROSPERO registration: CRD42015016914) PMID:28118127

Influence of Depth of Hypnosis on Pupillary Reactivity to a Standardized Tetanic Stimulus in Patients Under Propofol-Remifentanil Target-Controlled Infusion: A Crossover Randomized Pilot Study.

PubMed

Sabourdin, Nada; Peretout, Jean-Baptiste; Khalil, Eliane; Guye, Marie-Laurence; Louvet, Nicolas; Constant, Isabelle

2018-01-01

Pupillometry allows the measurement of pupillary diameter variations in response to nociceptive stimuli. This technique has been used to monitor the balance between analgesia and nociception. Under general anesthesia, the amplitude of pupillary dilation is related to the amount of administered opioids. The objective of this study was to determine whether at a constant infusion rate of opioids, the pupillary response was influenced by depth of hypnosis assessed by the bispectral index (BIS). Twelve patients (14-20 years) anesthetized for orthopedic surgery were included. Under propofol-remifentanil target-controlled infusion, remifentanil effect site target concentration was fixed at 1 ng/mL. Two measures of pupillary reflex dilation were performed on each patient in a randomized order: one at BIS 55 and one at BIS 25. These levels of BIS were obtained by adjusting propofol target concentration and maintained for 10 minutes before each measure. For each measure, we applied a standardized tetanic stimulation on the patient's forearm (60 mA, 100 Hz, 5 seconds). All measures were performed before the beginning of surgery. Pupillary dilation was significantly greater at BIS 55 than at BIS 25: 32.1% ± 5.3% vs 10.4% ± 2.5% (mean difference estimate [95% confidence interval]: 21.8% [12.9-30.6], P < .001), without carryover effect (P = .30) nor period effect (P = .52). Hemodynamic parameters and BIS were not modified by the stimulation. In patients receiving a constant infusion of remifentanil at a target concentration of 1 ng/mL, pupillary dilation after a standardized tetanic stimulation was influenced by depth of hypnosis assessed by the BIS.

Effect of feeding cassava bioethanol waste on nutrient intake, digestibility, and rumen fermentation in growing goats.

PubMed

Cherdthong, Anusorn; Pornjantuek, Boonserm; Wachirapakorn, Chalong

2016-10-01

This experiment was conducted to investigate the effects of various levels of cassava bioethanol waste (CBW) on nutrient intake, digestibility, rumen fermentation, and blood metabolites in growing goats. Twelve crossbred, male (Thai Native × Anglo Nubian) growing goats with initial body weight (BW) of 20±3 kg were randomly assigned according to a completely randomized design (CRD). The dietary treatments were total mixed ration (TMR) containing various levels of CBW at 0, 10, and 20 % dry matter (DM). CBW contained crude protein (CP), neutral detergent fiber (NDF), acid detergent fiber (ADF), and acid detergent lignin (ADL) at 11, 69, 47, and 23 % DM, respectively. The TMR diets were offered ad libitum and contained CP at 15 % DM. Inclusion of CBW at 10 % DM in TMR did not alter feed intake (g DM and g/kg BW(0.75)) and CP intake when compared to the control fed group (0 % CBW). Total OM intake was lower in the 20 % CBW group than in the others (P < 0.01). The digestibility coefficients of DM, OM, CP, and NDF were not changed for the TMR including 10 % CBW compared to the control group (P > 0.05) whereas when 20 % CBW was incorporated to diet, intermediate digestibility coefficients were decreased. Average ruminal pH values ranged from 6-7. Rumen NH3-N and PUN concentration at 0, 3, and 6 h post-feeding were not significantly different among treatments (P > 0.05). Thus, inclusion of 10 % CBW in TMR diets does not adversely affect nutrient intake, digestibility, rumen fermentation, and blood metabolite in fattening goats, and CBW may be effectively used as an alternative roughage source in the diets of goats.

Dose-Dependent Effects of Statins for Patients with Aneurysmal Subarachnoid Hemorrhage: Meta-Regression Analysis.

PubMed

To, Minh-Son; Prakash, Shivesh; Poonnoose, Santosh I; Bihari, Shailesh

2018-05-01

The study uses meta-regression analysis to quantify the dose-dependent effects of statin pharmacotherapy on vasospasm, delayed ischemic neurologic deficits (DIND), and mortality in aneurysmal subarachnoid hemorrhage. Prospective, retrospective observational studies, and randomized controlled trials (RCTs) were retrieved by a systematic database search. Summary estimates were expressed as absolute risk (AR) for a given statin dose or control (placebo). Meta-regression using inverse variance weighting and robust variance estimation was performed to assess the effect of statin dose on transformed AR in a random effects model. Dose-dependence of predicted AR with 95% confidence interval (CI) was recovered by using Miller's Freeman-Tukey inverse. The database search and study selection criteria yielded 18 studies (2594 patients) for analysis. These included 12 RCTs, 4 retrospective observational studies, and 2 prospective observational studies. Twelve studies investigated simvastatin, whereas the remaining studies investigated atorvastatin, pravastatin, or pitavastatin, with simvastatin-equivalent doses ranging from 20 to 80 mg. Meta-regression revealed dose-dependent reductions in Freeman-Tukey-transformed AR of vasospasm (slope coefficient -0.00404, 95% CI -0.00720 to -0.00087; P = 0.0321), DIND (slope coefficient -0.00316, 95% CI -0.00586 to -0.00047; P = 0.0392), and mortality (slope coefficient -0.00345, 95% CI -0.00623 to -0.00067; P = 0.0352). The present meta-regression provides weak evidence for dose-dependent reductions in vasospasm, DIND and mortality associated with acute statin use after aneurysmal subarachnoid hemorrhage. However, the analysis was limited by substantial heterogeneity among individual studies. Greater dosing strategies are a potential consideration for future RCTs. Copyright © 2018 Elsevier Inc. All rights reserved.

Impact of quality circles for improvement of asthma care: results of a randomized controlled trial

PubMed Central

Schneider, Antonius; Wensing, Michel; Biessecker, Kathrin; Quinzler, Renate; Kaufmann-Kolle, Petra; Szecsenyi, Joachim

2008-01-01

Rationale and aims Quality circles (QCs) are well established as a means of aiding doctors. New quality improvement strategies include benchmarking activities. The aim of this paper was to evaluate the efficacy of QCs for asthma care working either with general feedback or with an open benchmark. Methods Twelve QCs, involving 96 general practitioners, were organized in a randomized controlled trial. Six worked with traditional anonymous feedback and six with an open benchmark; both had guided discussion from a trained moderator. Forty-three primary care practices agreed to give out questionnaires to patients to evaluate the efficacy of QCs. Results A total of 256 patients participated in the survey, of whom 185 (72.3%) responded to the follow-up 1 year later. Use of inhaled steroids at baseline was high (69%) and self-management low (asthma education 27%, individual emergency plan 8%, and peak flow meter at home 21%). Guideline adherence in drug treatment increased (P = 0.19), and asthma steps improved (P = 0.02). Delivery of individual emergency plans increased (P = 0.008), and unscheduled emergency visits decreased (P = 0.064). There was no change in asthma education and peak flow meter usage. High medication guideline adherence was associated with reduced emergency visits (OR 0.24; 95% CI 0.07–0.89). Use of theophylline was associated with hospitalization (OR 7.1; 95% CI 1.5–34.3) and emergency visits (OR 4.9; 95% CI 1.6–14.7). There was no difference between traditional and benchmarking QCs. Conclusions Quality circles working with individualized feedback are effective at improving asthma care. The trial may have been underpowered to detect specific benchmarking effects. Further research is necessary to evaluate strategies for improving the self-management of asthma patients. PMID:18093108

Repair of Primary Cleft Palate and Oronasal Fistula With Acellular Dermal Matrix: A Systematic Review and Surgeon Survey.

PubMed

Simpson, Andrew; Samargandi, Osama A; Wong, Alison; Graham, M Elise; Bezuhly, Michael

2018-01-01

The current review and survey aim to assess the effectiveness of acellular dermal matrix (ADM) in the repair of cleft palate and oronasal fistula and to evaluate the current trends of ADM use in palate surgery. A systematic review of English articles was conducted using MEDLINE (1960 to July 1, 2016), the Cochrane Controlled Trials Register (1960 to July 1, 2016), and EMBASE (1991 to July 1, 2016). Additional studies were identified through a review of references cited in initially identified articles. Search terms included "cleft palate," "palatal," "oronasal fistula," "acellular dermal matrix," and "Alloderm®." An online survey was disseminated to members of the American Cleft Palate-Craniofacial Association to assess current trends in ADM use in palate surgery. All studies evaluating the outcome of primary palate repair or repair of oronasal fistula with the use of aceullar dermal matrix products were included in the review. Twelve studies met inclusion criteria for review. Studies were generally of low quality, as indicated by methodological index for non-randomized studies (MINORS) scores ranging from 7 to 14. The pooled estimate for fistula formation after primary palatoplasty following ADM use was 7.1%. The pooled estimate for recurrence of fistula after attempted repair using ADM was 11%. Thirty-six cleft surgeons responded to the online survey study. Of these, 45% used ADM in primary cleft palate repair, while 67% used ADM for repair of oronasal fistulae. Use of ADM products is commonplace in palate surgery. Despite this, there is a paucity of high-quality data demonstrating benefit. Further randomized controlled trials examining ADM in palate surgery are required to help develop structured guidelines and improve care.

Weight Loss Outcomes in Laparoscopic Vertical Sleeve Gastrectomy (LVSG) Versus Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) Procedures: A Meta-Analysis and Systematic Review of Randomized Controlled Trials.

PubMed

Osland, Emma; Yunus, Rossita M; Khan, Shahjahan; Memon, Breda; Memon, Muhammed A

2017-02-01

Laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic vertical sleeve gastrectomy (LVSG) have been proposed as cost-effective strategies to manage morbid obesity. The aim of this meta-analysis was to compare the postoperative weight loss outcomes reported in randomized control trials (RCTs) for LVSG versus LRYGB procedures. RCTs comparing the weight loss outcomes following LVSG and LRYGB in adult population between January 2000 and November 2015 were selected from PubMed, Medline, Embase, Science Citation Index, Current Contents, and the Cochrane database. The review was prepared in accordance with Preferred Reporting of Systematic Reviews and Meta-Analyses (PRISMA). Nine unique RCTs described over 10 publications involving a total of 865 patients (LVSG, n=437; LRYGB, n=428) were analyzed. Postoperative follow-up ranged from 3 months to 5 years. Twelve-month excess weight loss (EWL) for LVSG ranged from 69.7% to 83%, and for LRYGB, ranged from 60.5% to 86.4%. A number of studies reported slow weight gain between the second and third years of postoperative follow-up ranging from 1.4% to 4.2%EWL. This trend was seen to continue to 5 years postoperatively (8% to 10%EWL) for both procedures. In conclusion, LRYGB and LVSG are comparable with regards to the weight loss outcomes in the short term, with LRYGB achieving slightly greater weight loss. Slow weight recidivism is observed after the first postoperative year following both procedures. Long-term reporting of outcomes obtained from well-designed studies using intention-to-treat analyses are identified as a major gap in the literature at present.

Effectiveness of a multidisciplinary care program on recovery and return to work of patients after gynaecological surgery; design of a randomized controlled trial

PubMed Central

2012-01-01

Background Return to work after gynaecological surgery takes much longer than expected, irrespective of the level of invasiveness. In order to empower patients in recovery and return to work, a multidisciplinary care program consisting of an e-health intervention and integrated care management including participatory workplace intervention was developed. Methods/Design We designed a randomized controlled trial to assess the effect of the multidisciplinary care program on full sustainable return to work in patients after gynaecological surgery, compared to usual clinical care. Two hundred twelve women (18-65 years old) undergoing hysterectomy and/or laparoscopic adnexal surgery on benign indication in one of the 7 participating (university) hospitals in the Netherlands are expected to take part in this study at baseline. The primary outcome measure is sick leave duration until full sustainable return to work and is measured by a monthly calendar of sickness absence during 26 weeks after surgery. Secondary outcome measures are the effect of the care program on general recovery, quality of life, pain intensity and complications, and are assessed using questionnaires at baseline, 2, 6, 12 and 26 weeks after surgery. Discussion The discrepancy between expected physical recovery and actual return to work after gynaecological surgery contributes to the relevance of this study. There is strong evidence that long periods of sick leave can result in work disability, poorer general health and increased risk of mental health problems. We expect that this multidisciplinary care program will improve peri-operative care, contribute to a faster return to work of patients after gynaecological surgery and, as a consequence, will reduce societal costs considerably. Trial registration Netherlands Trial Register (NTR): NTR2087 PMID:22296950

Effectiveness of a multidisciplinary care program on recovery and return to work of patients after gynaecological surgery; design of a randomized controlled trial.

PubMed

Vonk Noordegraaf, Antonie; Huirne, Judith A F; Brölmann, Hans A M; Emanuel, Mark H; van Kesteren, Paul J M; Kleiverda, Gunilla; Lips, Jos P; Mozes, Alexander; Thurkow, Andreas L; van Mechelen, Willem; Anema, Johannes R

2012-02-01

Return to work after gynaecological surgery takes much longer than expected, irrespective of the level of invasiveness. In order to empower patients in recovery and return to work, a multidisciplinary care program consisting of an e-health intervention and integrated care management including participatory workplace intervention was developed. We designed a randomized controlled trial to assess the effect of the multidisciplinary care program on full sustainable return to work in patients after gynaecological surgery, compared to usual clinical care. Two hundred twelve women (18-65 years old) undergoing hysterectomy and/or laparoscopic adnexal surgery on benign indication in one of the 7 participating (university) hospitals in the Netherlands are expected to take part in this study at baseline. The primary outcome measure is sick leave duration until full sustainable return to work and is measured by a monthly calendar of sickness absence during 26 weeks after surgery. Secondary outcome measures are the effect of the care program on general recovery, quality of life, pain intensity and complications, and are assessed using questionnaires at baseline, 2, 6, 12 and 26 weeks after surgery. The discrepancy between expected physical recovery and actual return to work after gynaecological surgery contributes to the relevance of this study. There is strong evidence that long periods of sick leave can result in work disability, poorer general health and increased risk of mental health problems. We expect that this multidisciplinary care program will improve peri-operative care, contribute to a faster return to work of patients after gynaecological surgery and, as a consequence, will reduce societal costs considerably. Netherlands Trial Register (NTR): NTR2087.

Improvement in Depressive Symptoms Is Associated with Reduced Oxidative Damage and Inflammatory Response in Type 2 Diabetic Patients with Subsyndromal Depression: The Results of a Randomized Controlled Trial Comparing Psychoeducation, Physical Exercise, and Enhanced Treatment as Usual

PubMed Central

Vučić Lovrenčić, Marijana; Pibernik-Okanović, Mirjana; Šekerija, Mario; Prašek, Manja; Ajduković, Dea; Kos, Jadranka; Hermanns, Norbert

2015-01-01

Aims. To examine one-year changes in oxidative damage and inflammation level in type 2 diabetic patients undergoing behavioral treatment for subsyndromal depression. Materials and Methods. A randomized controlled comparison of psychoeducation (A), physical exercise (B), and enhanced treatment as usual (C) was performed in 209 eligible subjects in a tertiary diabetes care setting. Depressive symptoms (primary outcome) and selected biomarkers of oxidative damage and inflammation (secondary outcomes) were assessed at baseline and six- and twelve-month follow-up. Results. Out of the 74, 67, and 68 patients randomised into groups A, B, and C, respectively, 201 completed the interventions, and 179 were analysed. Participants in all three groups equally improved in depressive symptoms from baseline to one-year follow-up (repeated measures ANOVA; F = 12.51, p < 0.0001, η 2 = 0.07). Urinary 8-oxo-deoxyguanosine (u-8-oxodG) decreased (F = 10.66, p < 0.0001, η 2 = 0.06), as did sialic acid and leukocytes (F = 84.57, η 2 = 0.32 and F = 12.61, η 2 = 0.07, resp.; p < 0.0001), while uric acid increased (F = 12.53, p < 0.0001, η 2 = 0.07) in all subjects during one year. Improvement of depressive symptoms at 6 months significantly predicted one-year reduction in u-8-oxodG (β = 0.15, p = 0.044). Conclusion. Simple behavioral interventions are capable not only of alleviating depressive symptoms, but also of reducing the intensity of damaging oxidative/inflammatory processes in type 2 diabetic patients with subsyndromal depression. This trial is registered with ISRCTN05673017. PMID:26347775

A systematic review of financial incentives for dietary behavior change.

PubMed

Purnell, Jason Q; Gernes, Rebecca; Stein, Rick; Sherraden, Margaret S; Knoblock-Hahn, Amy

2014-07-01

In light of the obesity epidemic, there is growing interest in the use of financial incentives for dietary behavior change. Previous reviews of the literature have focused on randomized controlled trials and found mixed results. The purpose of this systematic review is to update and expand on previous reviews by considering a broader range of study designs, including randomized controlled trials, quasi-experimental, observational, and simulation studies testing the use of financial incentives to change dietary behavior and to inform both dietetic practice and research. The review was guided by theoretical consideration of the type of incentive used based on the principles of operant conditioning. There was further examination of whether studies were carried out with an institutional focus. Studies published between 2006 and 2012 were selected for review, and data were extracted regarding study population, intervention design, outcome measures, study duration and follow-up, and key findings. Twelve studies meeting selection criteria were reviewed, with 11 finding a positive association between incentives and dietary behavior change in the short term. All studies pointed to more specific information on the type, timing, and magnitude of incentives needed to motivate individuals to change behavior, the types of incentives and disincentives most likely to affect the behavior of various socioeconomic groups, and promising approaches for potential policy and practice innovations. Limitations of the studies are noted, including the lack of theoretical guidance in the selection of incentive structures and the absence of basic experimental data. Future research should consider these factors, even as policy makers and practitioners continue to experiment with this potentially useful approach to addressing obesity. Copyright © 2014 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

Feasibility of Wii Fit training to improve clinical measures of balance in older adults.

PubMed

Bieryla, Kathleen A; Dold, Neil M

2013-01-01

Numerous interventions have been proposed to improve balance in older adults with varying degrees of success. A novel approach may be to use an off-the-shelf video game system utilizing real-time force feedback to train older adults. The purpose of this study is to investigate the feasibility of using Nintendo's Wii Fit for training to improve clinical measures of balance in older adults and to retain the improvements after a period of time. Twelve healthy older adults (aged >70 years) were randomly divided into two groups. The experimental group completed training using Nintendo's Wii Fit game three times a week for 3 weeks while the control group continued with normal activities. Four clinical measures of balance were assessed before training, 1 week after training, and 1 month after training: Berg Balance Scale (BBS), Fullerton Advanced Balance (FAB) scale, Functional Reach (FR), and Timed Up and Go (TUG). Friedman two-way analysis of variance by ranks was conducted on the control and experimental group to determine if training using the Wii Balance Board with Wii Fit had an influence on clinical measures of balance. Nine older adults completed the study (experimental group n = 4, control group n = 5). The experimental group significantly increased their BBS after training while the control group did not. There was no significant change for either group with FAB, FR, and TUG. Balance training with Nintendo's Wii Fit may be a novel way for older adults to improve balance as measured by the BBS.

Dexamethasone therapy for preventing delayed encephalopathy after carbon monoxide poisoning.

PubMed

Li, Q; Song, J J; Zhang, H Y; Fu, K; Lan, H B; Deng, Y

2015-01-01

We investigated dexamethasone therapy for preventing delayed encephalopathy after carbon monoxide (CO) poisoning. Eighty healthy male rats were exposed to CO and randomly divided into four groups: hyperbaric oxygen treatment (H), treatment (D), combined hyperbaric and dexamethasone treatment (C), and a control (M) group in which the rats inhaled CO to coma in the hyperbaric oxygen chamber, then were removed without further treatment. Twelve rats were put into the hyperbaric oxygen chamber and treated with air for 60 min (N) group. An eight arm maze was used to evaluate cognitive and memory abilities of these mice. Serum myelin basic protein (MBP) levels were evaluated using ELISA, and magnetic resonance imaging was used to observe brain demyelination and morbidity associated with delayed encephalopathy. A sample of the hippocampus from each group was examined by light microscopy. Cognitive and memory functions decreased in the control group M. Three days after CO poisoning, the serum MBP level of each group increased significantly. On Day 10 after CO poisoning, the MBP levels in groups C and D decreased significantly, but returned to normal on Day 18. MBP levels in the M and H groups were elevated at all time points. Brain MRIs showed significant differences among C, D, H and control M groups. Hematoxylin & eosin staining of the hippocampus showed greater damage in the control M and H groups. Early dexamethasone treatment may be useful for preventing delayed encephalopathy after CO poisoning and may reduce serum MBP levels.

EFFECTS OF MOVEABLE PLATFORM TRAINING IN PREVENTING SLIP-INDUCED FALLS IN OLDER ADULTS

PubMed Central

Parijat, Prakriti; Lockhart, Thurmon E

2011-01-01

Identifying effective interventions is vitalin preventing slip-induced fall accidents in older adults. The purpose of the current study was to evaluate the efficacy of moveable platform training in improving recovery reactions and reducing fall frequency in older adults. Twenty-four older adults were recruited and randomly assigned to two groups (training and control). Both groups underwent three sessions including baseline slip, training, and transfer of training on a slippery surface. Both groups experienced two slips on a slippery surface, one during the baseline and the other (after two weeks) during the transfer of training session. In the training session, the training group underwent twelve simulated slips using a moveable platform while the control group performed normal walking trials. Kinematic, kinetic, and EMG data were collected during all the sessions. Results indicated a reduced incidence of falls in the training group during the transfer of training trial as compared to the control group. The training group was able to transfer proactive and reactive control strategies learned during training to the second slip trial. The proactive adjustments include increased center-of-mass velocity and transitional acceleration after training. Reactive adjustments include reduction in muscle onset and time to peak activations of knee flexors and ankle plantarflexors, reduced ankle and knee coactivation, reduced slip displacement, and reduced time to peak knee flexion, trunk flexion, and hip flexion velocities. In general, the results indicated a beneficial effect of perturbation training in reducing slip severity and recovery kinematics in healthy older adults. PMID:22134467

The Spacelab 3 simulation: basis for a model of growth plate response in microgravity in the rat

NASA Technical Reports Server (NTRS)

Montufar-Solis, D.; Duke, P. J.; Morey-Holton, E.

2001-01-01

Data from Spacelab 3 (SL3) suggested that spaceflight significantly reduces the activity of the rat tibial growth plate. Animal processing after SL3 began twelve hours post-landing, so data reflect post-flight re-adaptation in addition to spaceflight effects. To determine if a twelve-hour period of weight bearing after seven days of unloading could affect the physes of spaceflown rats, the present study assessed the growth plate response to unloading with or without a reloading period. Rats were subjected to hind-limb suspension for seven days and then euthanized, with or without twelve hours of reloading. Activity of the growth plate was assessed by morphometric analysis. Rats suspended without reloading had reserve zone (RZ) height greater than controls, and shorter hypertrophy/calcification zone (HCZ) with fewer cells. The greater RZ was associated with a larger cell area, indicating a possible mitotic delay or secretion defect. Twelve hours of reloading decreased RZ height and cell number, and restored the number of cells in HCZ to control values, but the number of cells in the proliferative zone and height in HCZ were reduced. These results suggest the rebound response to preserve/restore skeletal function after a period of unloading involves an acceleration of growth associated with a decreased cell cycle time in PZ. Changes during the reloading period in this simulation support our hypothesis that the effects of spaceflight on SL3 growth plates were altered by changes that occurred post-landing. The similarities in response to unloading by suspension or during spaceflight are used to propose a model of growth plate response during spaceflight.

Treatment outcomes using CBT-IA with Internet-addicted patients.

PubMed

Young, Kimberly S

2013-12-01

Internet Gaming Disorder, a subtype of Internet Addiction, is now classified in Section 3 of the DSM-5. Cognitive behavioral therapy (CBT) has been suggested in treating Internet addiction as this modality has been shown to be an effective treatment for similar impulse control disorders. Given the daily and necessary use of the Internet and technology in general compared to other compulsive syndromes, a specialized form of CBT has been developed called Cognitive-Behavioral Therapy for Internet Addiction (CBT-IA). CBT-IA is a comprehensive three phase approach that includes behavior modification to control compulsive Internet use, cognitive restructuring to identify, challenge, and modify cognitive distortions that lead to addictive use, and harm reduction techniques to address and treat co-morbid issues associated with the disorder. As the first model of its kind, this study examines 128 clients to measure treatment outcomes using CBT-IA. Clients were evaluated using the Internet Addiction Test (IAT) to classify subjects and were administered twelve weekly sessions of CBT-IA. Treatment outcomes were measured at the end of the twelve weeks, one-month, three months and at six month post-treatment. RESULTS showed that over 95% of clients were able to manage symptoms at the end of the twelve weeks and 78% sustained recovery six months following treatment. RESULTS found that CBT-IA was effective at ameliorating symptoms associated with Internet addiction after twelve weekly sessions and consistently over one-month, three months, and six months after therapy. Further research implications such as investigating long-term outcome effects of the model with larger client populations and treatment differences among the subtypes of Internet addiction or with other cultural populations using CBT-IA are discussed.

Laws of the United States Relating to Water Pollution Control and Environmental Quality.

ERIC Educational Resources Information Center

Congress of the U.S., Washington, DC. House Committee on Public Works.

This compilation of Federal legislation contains copies of twelve Public Laws, four Executive Orders, and five International Conventions relevant to water pollution control. It also contains two Public Laws and two Executive Orders pertaining to environmental quality. There is a brief introduction summarizing the provisions of each Act. (AL)

Functional Dysphonia during Mental Imagery: Testing the Trait Theory of Voice Disorders

ERIC Educational Resources Information Center

van Mersbergen, Miriam; Patrick, Christopher; Glaze, Leslie

2008-01-01

Purpose: Previous research has proposed that persons with functional dysphonia (FD) present with temperamental traits that predispose them to their voice disorder. We investigated this theory in a controlled experiment and compared them with social anxiety (SA) and healthy control (HC) groups. Method: Twelve participants with FD, 19 participants…

Lawn Weeds and Their Control. North Central Regional Extension Publication No. 26.

ERIC Educational Resources Information Center

Purdue Univ., Lafayette, IN. Cooperative Extension Service.

This publication discusses lawn weed control for the twelve state north central region of the country. Written for use by homeowners, the publication focuses on weed identification and proper herbicide selection and application. Identification of weeds and safe and appropriate herbicide use are emphasized. Forty-six weed and turf plants are…

MRI-tracking of transplanted human ASC in a SCID mouse model

NASA Astrophysics Data System (ADS)

Siegmund, Birte J.; Kasten, Annika; Kühn, Jens-Peter; Winter, Karsten; Grüttner, Cordula; Frerich, Bernhard

2017-04-01

Additional Prussian blue stain showed iron in all implants. Significant differences between the three groups (significance level p<0.017) were found after twelve days between control group and group 3 (p=0.008) and after 28 days between control group and group 2 and 3 (p=0.011).

Time dependent genetic analysis links field and controlled environment phenotypes in the model C4 grass Setaria

USDA-ARS?s Scientific Manuscript database

Vertical growth of plants is a dynamic process that is influenced by genetic and environmental factors and has a pronounced effect on overall plant architecture and biomass composition. We have performed twelve controlled growth trials of an interspecific Setaria italica x Setaria viridis recombinan...

Effects of topical oxygen therapy on ischemic wound healing.

PubMed

Rao, Congqiang; Xiao, Liling; Liu, Hongwei; Li, Shenghong; Lu, Jinqiang; Li, Jiangxuan; Gu, Shixing

2016-01-01

[Purpose] This study evaluated the effects of topical oxygen therapy on the hind limb wounds of rats under ischemic conditions. [Subjects and Methods] Twelve injured rats were treated with topical oxygen on skin wounds located on the hind limb and compared with twelve injured control rats. Indexes including gross morphology of the wound, wound healing time, wound healing rate, and histological and immunohistochemical staining of sections of wound tissue were examined at different time points after intervention. [Results] The wound healing time was shorter in the topical oxygen therapy group than the control group. The wound healing rate and granulation tissue formation in the topical oxygen therapy group showed significant improvement on days 3, 7, and 14. Through van Gieson staining, the accumulation of collagen fiber in the topical oxygen therapy group was found to have improved when compared with the control group on day 7. Through semiquantitative immunohistochemical staining, many more new vessels were found in the topical oxygen therapy group compared with the model control group on day 7. [Conclusion] The results of the experiment showed that topical oxygen therapy improved ischemic wound healing.

Prospective Randomized Study of Doxorubicin-Eluting-Bead Embolization in the Treatment of Hepatocellular Carcinoma: Results of the PRECISION V Study

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

Lammer, Johannes, E-mail: johannes.lammer@meduniwien.ac.a; Malagari, Katarina; Vogl, Thomas

2010-02-15

Transcatheter arterial chemoembolization (TACE) offers a survival benefit to patients with intermediate hepatocellular carcinoma (HCC). A widely accepted TACE regimen includes administration of doxorubicin-oil emulsion followed by gelatine sponge-conventional TACE. Recently, a drug-eluting bead (DC Bead) has been developed to enhance tumor drug delivery and reduce systemic availability. This randomized trial compares conventional TACE (cTACE) with TACE with DC Bead for the treatment of cirrhotic patients with HCC. Two hundred twelve patients with Child-Pugh A/B cirrhosis and large and/or multinodular, unresectable, N0, M0 HCCs were randomized to receive TACE with DC Bead loaded with doxorubicin or cTACE with doxorubicin. Randomizationmore » was stratified according to Child-Pugh status (A/B), performance status (ECOG 0/1), bilobar disease (yes/no), and prior curative treatment (yes/no). The primary endpoint was tumor response (EASL) at 6 months following independent, blinded review of MRI studies. The drug-eluting bead group showed higher rates of complete response, objective response, and disease control compared with the cTACE group (27% vs. 22%, 52% vs. 44%, and 63% vs. 52%, respectively). The hypothesis of superiority was not met (one-sided P = 0.11). However, patients with Child-Pugh B, ECOG 1, bilobar disease, and recurrent disease showed a significant increase in objective response (P = 0.038) compared to cTACE. DC Bead was associated with improved tolerability, with a significant reduction in serious liver toxicity (P < 0.001) and a significantly lower rate of doxorubicin-related side effects (P = 0.0001). TACE with DC Bead and doxorubicin is safe and effective in the treatment of HCC and offers a benefit to patients with more advanced disease.« less

Hands-Off Time for Endotracheal Intubation during CPR Is Not Altered by the Use of the C-MAC Video-Laryngoscope Compared to Conventional Direct Laryngoscopy. A Randomized Crossover Manikin Study.

PubMed

Schuerner, Philipp; Grande, Bastian; Piegeler, Tobias; Schlaepfer, Martin; Saager, Leif; Hutcherson, Matthew T; Spahn, Donat R; Ruetzler, Kurt

2016-01-01

Sufficient ventilation and oxygenation through proper airway management is essential in patients undergoing cardio-pulmonary resuscitation (CPR). Although widely discussed, securing the airway using an endotracheal tube is considered the standard of care. Endotracheal intubation may be challenging and causes prolonged interruption of chest compressions. Videolaryngoscopes have been introduced to better visualize the vocal cords and accelerate intubation, which makes endotracheal intubation much safer and may contribute to intubation success. Therefore, we aimed to compare hands-off time and intubation success of direct laryngoscopy with videolaryngoscopy (C-MAC, Karl Storz, Tuttlingen, Germany) in a randomized, cross-over manikin study. Twenty-six anesthesia residents and twelve anesthesia consultants of the University Hospital Zurich were recruited through a voluntary enrolment. All participants performed endotracheal intubation using direct laryngoscopy and C-MAC in a random order during ongoing chest compressions. Participants were strictly advised to stop chest compression only if necessary. The median hands-off time was 1.9 seconds in direct laryngoscopy, compared to 3 seconds in the C-MAC group. In direct laryngoscopy 39 intubation attempts were recorded, resulting in an overall first intubation attempt success rate of 97%, compared to 38 intubation attempts and 100% overall first intubation attempt success rate in the C-MAC group. As a conclusion, the results of our manikin-study demonstrate that video laryngoscopes might not be beneficial compared to conventional, direct laryngoscopy in easily accessible airways under CPR conditions and in experienced hands. The benefits of video laryngoscopes are of course more distinct in overcoming difficult airways, as it converts a potential "blind intubation" into an intubation under visual control.

Diabetes mellitus and abnormal glucose tolerance development after gestational diabetes: A three-year, prospective, randomized, clinical-based, Mediterranean lifestyle interventional study with parallel groups.

PubMed

Pérez-Ferre, Natalia; Del Valle, Laura; Torrejón, Maria José; Barca, Idoya; Calvo, María Isabel; Matía, Pilar; Rubio, Miguel A; Calle-Pascual, Alfonso L

2015-08-01

Women with prior gestational diabetes mellitus (GDM) have a high risk of developing type 2 diabetes mellitus (DM2) in later life. The study aim was to evaluate the efficacy of a lifestyle intervention for the prevention of glucose disorders (impaired fasting glucose, impaired glucose tolerance or DM2) in women with prior GDM. A total of 260 women with prior GDM who presented with normal fasting plasma glucose at six to twelve weeks postpartum were randomized into two groups: a Mediterranean lifestyle intervention group (n = 130) who underwent an educational program on nutrition and a monitored physical activity program and a control group (n = 130) with a conventional follow-up. A total of 237 women completed the three-year follow-up (126 in the intervention group and 111 in the control group). Their glucose disorders rates, clinical and metabolic changes and rates of adherence to the Mediterranean lifestyle were analyzed. Less women in the intervention group (42.8%) developed glucose disorders at the end of the three-year follow-up period compared with the control group (56.75%), p < 0.05. The multivariate analysis indicated a reduction in the rate of glucose disorders with a BMI of less than 27 kg/m(2) (OR 0.28; 0.12-0.65; p < 0.003), low fat intake pattern (OR 0.30; 0.13-0.70; p < 0.005), low saturated fat pattern (OR 0.30; 0.13-0.69; p < 0.005) and healthy fat pattern (OR 0.34; 0.12-0.94; p < 0.04). Lifestyle intervention was effective for the prevention of glucose disorders in women with prior GDM. Body weight gain and an unhealthy fat intake pattern were found to be the most predictive factors for the development of glucose disorders. Current Controlled trials: ISRCTN24165302. http://www.controlled-trials.com/isrctn/pf/24165302. Copyright © 2014 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Random Plant Viral Variants Attain Temporal Advantages During Systemic Infections and in Turn Resist other Variants of the Same Virus.

PubMed

Zhang, Xiao-Feng; Guo, Jiangbo; Zhang, Xiuchun; Meulia, Tea; Paul, Pierce; Madden, Laurence V; Li, Dawei; Qu, Feng

2015-10-20

Infection of plants with viruses containing multiple variants frequently leads to dominance by a few random variants in the systemically infected leaves (SLs), for which a plausible explanation is lacking. We show here that SL dominance by a given viral variant is adequately explained by its fortuitous lead in systemic spread, coupled with its resistance to superinfection by other variants. We analyzed the fate of a multi-variant turnip crinkle virus (TCV) population in Arabidopsis and N. benthamiana plants. Both wild-type and RNA silencing-defective plants displayed a similar pattern of random dominance by a few variant genotypes, thus discounting a prominent role for RNA silencing. When introduced to plants sequentially as two subpopulations, a twelve-hour head-start was sufficient for the first set to dominate. Finally, SLs of TCV-infected plants became highly resistant to secondary invasions of another TCV variant. We propose that random distribution of variant foci on inoculated leaves allows different variants to lead systemic movement in different plants. The leading variants then colonize large areas of SLs, and resist the superinfection of lagging variants in the same areas. In conclusion, superinfection resistance is the primary driver of random enrichment of viral variants in systemically infected plants.

Promoting state health department evidence-based cancer and chronic disease prevention: a multi-phase dissemination study with a cluster randomized trial component

PubMed Central

2013-01-01

Background Cancer and other chronic diseases reduce quality and length of life and productivity, and represent a significant financial burden to society. Evidence-based public health approaches to prevent cancer and other chronic diseases have been identified in recent decades and have the potential for high impact. Yet, barriers to implement prevention approaches persist as a result of multiple factors including lack of organizational support, limited resources, competing emerging priorities and crises, and limited skill among the public health workforce. The purpose of this study is to learn how best to promote the adoption of evidence based public health practice related to chronic disease prevention. Methods/design This paper describes the methods for a multi-phase dissemination study with a cluster randomized trial component that will evaluate the dissemination of public health knowledge about evidence-based prevention of cancer and other chronic diseases. Phase one involves development of measures of practitioner views on and organizational supports for evidence-based public health and data collection using a national online survey involving state health department chronic disease practitioners. In phase two, a cluster randomized trial design will be conducted to test receptivity and usefulness of dissemination strategies directed toward state health department chronic disease practitioners to enhance capacity and organizational support for evidence-based chronic disease prevention. Twelve state health department chronic disease units will be randomly selected and assigned to intervention or control. State health department staff and the university-based study team will jointly identify, refine, and select dissemination strategies within intervention units. Intervention (dissemination) strategies may include multi-day in-person training workshops, electronic information exchange modalities, and remote technical assistance. Evaluation methods include pre-post surveys, structured qualitative phone interviews, and abstraction of state-level chronic disease prevention program plans and progress reports. Trial registration clinicaltrials.gov: NCT01978054. PMID:24330729

Effect of study design on the reported effect of cardiac resynchronization therapy (CRT) on quantitative physiological measures: stratified meta-analysis in narrow-QRS heart failure and implications for planning future studies.

PubMed

Jabbour, Richard J; Shun-Shin, Matthew J; Finegold, Judith A; Afzal Sohaib, S M; Cook, Christopher; Nijjer, Sukhjinder S; Whinnett, Zachary I; Manisty, Charlotte H; Brugada, Josep; Francis, Darrel P

2015-01-06

Biventricular pacing (CRT) shows clear benefits in heart failure with wide QRS, but results in narrow QRS have appeared conflicting. We tested the hypothesis that study design might have influenced findings. We identified all reports of CRT-P/D therapy in subjects with narrow QRS reporting effects on continuous physiological variables. Twelve studies (2074 patients) met these criteria. Studies were stratified by presence of bias-resistance steps: the presence of a randomized control arm over a single arm, and blinded outcome measurement. Change in each endpoint was quantified using a standardized effect size (Cohen's d). We conducted separate meta-analyses for each variable in turn, stratified by trial quality. In non-randomized, non-blinded studies, the majority of variables (10 of 12, 83%) showed significant improvement, ranging from a standardized mean effect size of +1.57 (95%CI +0.43 to +2.7) for ejection fraction to +2.87 (+1.78 to +3.95) for NYHA class. In the randomized, non-blinded study, only 3 out of 6 variables (50%) showed improvement. For the randomized blinded studies, 0 out of 9 variables (0%) showed benefit, ranging from -0.04 (-0.31 to +0.22) for ejection fraction to -0.1 (-0.73 to +0.53) for 6-minute walk test. Differences in degrees of resistance to bias, rather than choice of endpoint, explain the variation between studies of CRT in narrow-QRS heart failure addressing physiological variables. When bias-resistance features are implemented, it becomes clear that these patients do not improve in any tested physiological variable. Guidance from studies without careful planning to resist bias may be far less useful than commonly perceived. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

School-Based and Community-Based Gun Safety Educational Strategies for Injury Prevention.

PubMed

Holly, Cheryl; Porter, Sallie; Kamienski, Mary; Lim, Aubrianne

2018-05-01

Nearly 1,300 children in the United States die because of firearm-related injury each year and another 5,790 survive gunshot wounds, making the prevention of firearm-related unintentional injury to children of vital importance to families, health professionals, and policy makers. To systematically review the evidence on school-based and community-based gun safety programs for children aged 3 to 18 years. Systematic review. Twelve databases were searched from their earliest records to December 2016. Interventional and analytic studies were sought, including randomized controlled trials, quasi-experimental studies, as well as before-and-after studies or cohort studies with or without a control that involved an intervention. The low level of evidence, heterogeneity of studies, and lack of consistent outcome measures precluded a pooled estimate of results. A best evidence synthesis was performed. Results support the premise that programs using either knowledge-based or active learning strategies or a combination of these may be insufficient for teaching gun safety skills to children. Gun safety programs do not improve the likelihood that children will not handle firearms in an unsupervised situation. Stronger research designs with larger samples are needed to determine the most effective way to transfer the use of the gun safety skills outside the training session and enable stronger conclusions to be drawn.

Repeated oral administration of a cathepsin K inhibitor significantly suppresses bone resorption in exercising horses with evidence of increased bone formation and maintained bone turnover.

PubMed

Hussein, H; Dulin, J; Smanik, L; Drost, W T; Russell, D; Wellman, M; Bertone, A

2017-08-01

Our investigations evaluated the effect of VEL-0230, a highly specific irreversible inhibitor of cathepsin K (CatK). The objectives of our study were to determine whether repeated dosing of a CatK inhibitor (CatKI) produced a desired inhibition of the bone resorption biomarker (CTX-1), and document the effect of repeated dosing on bone homeostasis, structure, and dynamics of bone resorption and formation in horses. Twelve young exercising horses were randomized in a prospective, controlled clinical trial and received 4 weekly doses of a CatKI or vehicle. Baseline and poststudy nuclear scintigraphy, blood sampling and analysis of plasma bone biomarkers (CTX-1 and osteocalcin), poststudy bone fluorescent labeling, and bone biopsy were performed. Bone specimens were further processed for microcomputed tomography and bone histomorphometry. Each dose of this CatKI transiently inhibited plasma CTX-1 (reflecting inhibition of bone collagen resorption) and increased bone plasma osteocalcin concentrations, with no detectable adverse effect on normal bone turnover in the face of exercise. Bone morphology, density, and formation rate were not different between control and treated group. Further investigation of CatK inhibition in abnormal bone turnover is required in animals with bone diseases. © 2016 John Wiley & Sons Ltd.

Acute Heat Stress Changes Protein Expression in the Testes of a Broiler-Type Strain of Taiwan Country Chickens.

PubMed

Wang, Shih-Han; Cheng, Chuen-Yu; Chen, Chao-Jung; Chan, Hong-Lin; Chen, Hsin-Hsin; Tang, Pin-Chi; Chen, Chih-Feng; Lee, Yen-Pai; Huang, San-Yuan

2018-03-19

Heat stress leads to decreased fertility in roosters. This study investigated the global protein expression in response to acute heat stress in the testes of a broiler-type strain of Taiwan country chickens (TCCs). Twelve 45-week-old roosters were randomly allocated to the control group maintained at 25°C, and three groups subjected to acute heat stress at 38°C for 4 h, with 0, 2, and 6 h of recovery, respectively. Testis samples were collected for hematoxylin and eosin staining, apoptosis assay, and protein analysis. The results revealed 101 protein spots that differed significantly from the control following exposure to acute heat stress. The proteins that were differentially expressed participated mainly in protein metabolism and other metabolic processes, responses to stimuli, apoptosis, cellular organization, and spermatogenesis. Proteins that negatively regulate apoptosis were downregulated and proteins involved in autophagy and major heat shock proteins (HSP90α, HSPA5, and HSPA8) were upregulated in the testes of heat-stressed chickens. In conclusion, acute heat stress causes a change in protein expression in the testes of broiler-type B strain TCCs and may thus impair cell morphology, spermatogenesis, and apoptosis. The expression of heat shock proteins increased to attenuate the testicular injury induced by acute heat stress.

PYY3–36 and Oxyntomodulin Can Be Additive in Their Effect on Food Intake in Overweight and Obese Humans

PubMed Central

Field, Benjamin C.T.; Wren, Alison M.; Peters, Veronique; Baynes, Kevin C.R.; Martin, Niamh M.; Patterson, Michael; Alsaraf, Sara; Amber, Vian; Wynne, Katie; Ghatei, Mohammad A.; Bloom, Stephen R.

2010-01-01

OBJECTIVE Peptide YY3–36 (PYY3–36), a Y2 receptor agonist, and oxyntomodulin, a glucagon-like peptide 1 (GLP-1) receptor agonist, are cosecreted by intestinal L-cells after each meal. Separately each hormone acts as an endogenous satiety signal and reduces appetite in humans when infused intravenously. The aim of the current study was to investigate whether the anorectic effects of PYY3–36 and oxyntomodulin can be additive. RESEARCH DESIGN AND METHODS Twelve overweight or obese human volunteers underwent a randomized, double-blinded, placebo-controlled study. An ad libitum test meal was used to measure energy intake during intravenous infusions of either PYY3–36 or oxyntomodulin or combined PYY3–36/oxyntomodulin. RESULTS Energy intake during coadministration of PYY3–36 and oxyntomodulin was reduced by 42.7% in comparison with the saline control and was significantly lower than that during infusions of either hormone alone. CONCLUSIONS The anorectic effects of PYY3–36 and oxyntomodulin can be additive in overweight and obese humans. Coadministration of Y2 receptor agonists and GLP-1 receptor agonists may be a useful treatment strategy for obesity. PMID:20357366

A controlled trial of an intervention to improve urinary and fecal incontinence and constipation.

PubMed

Schnelle, John F; Leung, Felix W; Rao, Satish S C; Beuscher, Linda; Keeler, Emmett; Clift, Jack W; Simmons, Sandra

2010-08-01

To evaluate effects of a multicomponent intervention on fecal incontinence (FI) and urinary incontinence (UI) outcomes. Randomized controlled trial. Six nursing homes (NHs). One hundred twelve NH residents. Intervention subjects were offered toileting assistance, exercise, and choice of food and fluid snacks every 2 hours for 8 hours per day over 3 months. Frequency of UI and FI and rate of appropriate toileting as determined by direct checks from research staff. Anorectal assessments were completed on a subset of 29 residents. The intervention significantly increased physical activity, frequency of toileting, and food and fluid intake. UI improved (P=.049), as did frequency of bowel movements (P<.001) and percentage of bowel movements (P<.001) in the toilet. The frequency of FI did not change. Eighty-nine percent of subjects who underwent anorectal testing showed a dyssynergic voiding pattern, which could explain the lack of efficacy of this intervention program alone on FI. This multicomponent intervention significantly changed multiple risk factors associated with FI and increased bowel movements without decreasing FI. The dyssynergic voiding pattern and rectal hyposensitivity suggest that future interventions may have to be supplemented with bulking agents (fiber), biofeedback therapy, or both to improve bowel function. © 2010, Copyright the Authors. Journal compilation © 2010, The American Geriatrics Society.

Effect of pitavastatin in different SLCO1B1 backgrounds on repaglinide pharmacokinetics and pharmacodynamics in healthy Chinese males.

PubMed

Zhu, Jie; Song, Min; Tan, Hong-Yi; Huang, Li-Hua; Huang, Zhi-Jun; Liu, Chang; Fu, Zhi-Min; Huang, Yuan-Yuan; Tan, Zhi-Rong; Chen, Xiao-Ping; Yuan, Hong; Yang, Guo-Ping

2013-05-01

The effect of pitavastatin and SLCO1B1 genetic background on the pharmacokinetic and pharmacodynamic properties of repaglinide was investigated. In this randomized, placebo-controlled, crossover study, twelve healthy Chinese males were administered with pitavastatin 4 mg/d or the placebo for 5 d followed by repaglinide 4 mg given orally on d 5. Plasma repaglinide and glucose levels were measured by liquid chromatography-tandem mass spectrometry (LC/MS/MS) and the glucose oxidase method, respectively. Treatment with pitavastatin significantly increased the peak plasma concentration (Cmax) of repaglinide (P=0.003) in SLCO1B1*1b homozygotes (P=0.015) and SLCO1B1*15 carriers (P=0.031). Treatment with pitavastatin led to a marginal increase in the area under plasma concentration-time curve from 0 h to infinity (AUC0⇒∞) of repaglinide (P=0.091). There was no significant difference in pharmacokinetic parameters or hypoglycemic effects of repaglinide among SLCO1B1 genotypes in either the pitavastatin or control group. Pitavastatin increased the Cmax of the plasma concentration of repaglinide in an SLCO1B1 genotype dependent manner, but had no apparent effect on the pharmacodynamics of repaglinide in healthy volunteers. The p values for this statement were not reported.

[Influence of different surgeries on growth and development of alar cartilage in young-rabbit].

PubMed

Jiang, Lian; Dong, Xiqian; Song, Qinggao; Chen, Shang; Zou, Sihai

2011-01-01

The purpose of this study is to observe the affection of different clinical surgeries on alar nasal cartilages' growth and development. The experimental results can provide some theory basis for clinical surgeries. Twenty-eight New Zealand immature rabbits were used in this study, and divided into normal control group, hidden dissection group and cutting off alar nasal cartilages group randomly, which included 4,12 and 12 rabbits, separately. Arc incision were made on the mucous membrane of nasal cavity,and then dissect the alar nasal cartilages hidden or cut off the alar nasal cartilages, separately. The growth and development of the alar cartilage were observed at different stages after the surgery using histological and immuno-histochemical methods. Four weeks, eight weeks, twelve weeks and sixteen weeks after surgery, there were no significant differences in the indexes of chondrocytes between hidden dissection group and control group. In cutting off alar nasal cartilages group, fiber tissue were observed in the vacancy left after being cut off cartilages, and even mucous membrane tissue could be seen in some slices. There is no adverse influence on the growth and development of the alar cartilage after being hidden dissected. Contrarily, the restoring capability of transparent cartilage cannot counteract the injury resulted form the surgery after the alar nasal cartilages being cut off.

Premium-Based Financial Incentives Did Not Promote Workplace Weight Loss In A 2013-15 Study.

PubMed

Patel, Mitesh S; Asch, David A; Troxel, Andrea B; Fletcher, Michele; Osman-Koss, Rosemary; Brady, Jennifer; Wesby, Lisa; Hilbert, Victoria; Zhu, Jingsan; Wang, Wenli; Volpp, Kevin G

2016-01-01

Employers commonly use adjustments to health insurance premiums as incentives to encourage healthy behavior, but the effectiveness of those adjustments is controversial. We gave 197 obese participants in a workplace wellness program a weight loss goal equivalent to 5 percent of their baseline weight. They were randomly assigned to a control arm, with no financial incentive for achieving the goal, or to one of three intervention arms offering an incentive valued at $550. Two intervention arms used health insurance premium adjustments, beginning the following year (delayed) or in the first pay period after achieving the goal (immediate). A third arm used a daily lottery incentive separate from premiums. At twelve months there were no statistically significant differences in mean weight change either between the control group (whose members had a mean gain of 0.1 pound) and any of the incentive groups (delayed premium adjustment, -1.2 pound; immediate premium adjustment, -1.4 pound; daily lottery incentive, -1.0 pound) or among the intervention groups. The apparent failure of the incentives to promote weight loss suggests that employers that encourage weight reduction through workplace wellness programs should test alternatives to the conventional premium adjustment approach by using alternative incentive designs, larger incentives, or both. Project HOPE—The People-to-People Health Foundation, Inc.

Twelve-month effects of the COPE Healthy Lifestyles TEEN Program on Overweight and Depressive Symptoms in high school adolescents

PubMed Central

Jacobson, Diana; Kelly, Stephanie A.; Belyea, Michael J.; Shaibi, Gabriel Q.; Small, Leigh; O’Haver, Judith A.; Marsiglia, Flavio Francisco

2015-01-01

BACKGROUND We evaluated the 12-month effects of the COPE (Creating Opportunities for Personal Empowerment) Healthy Lifestyles TEEN (Thinking, Emotions, Exercise, Nutrition) program versus an attention control program (Healthy Teens) on overweight/obesity and depressive symptoms in high school adolescents. METHODS A cluster randomized controlled trial was conducted. Participants were 779 culturally diverse adolescents in the US Southwest. COPE is a cognitive-behavioral skills-building intervention with 20 minutes of physical activity integrated into a health course and taught by teachers once a week for 15 weeks. Outcome measures included body mass index (BMI) and depressive symptoms. RESULTS COPE teens had a significantly lower BMI at 12 months (F1, 698 = 11.22, p = .001) than Healthy Teens (24.95 versus 25.48). There was a significant decrease in the proportion of overweight and obese COPE teens from baseline to 12 months (χ2= 5.40, p = .02) as compared to Healthy Teens. For youth who began the study with extremely elevated depressive symptoms, COPE teens had significantly lower depression at 12 months compared to Healthy Teens (COPE M=42.39; Healthy Teens M=57.90); (F1, 12 = 5.78, p = .03). CONCLUSIONS COPE can improve long-term physical and mental health outcomes in teens. PMID:26522175

Preventing Obesity Among Adolescent Girls: One-Year Outcomes of the Nutrition and Enjoyable Activity for Teen Girls (NEAT Girls) Cluster Randomized Controlled Trial.

PubMed

Lubans, David R; Morgan, Philip J; Okely, Anthony D; Dewar, Deborah; Collins, Clare E; Batterham, Marijka; Callister, Robin; Plotnikoff, Ronald C

2012-09-01

OBJECTIVE To evaluate the impact of a 12-month multicomponent school-based obesity prevention program, Nutrition and Enjoyable Activity for Teen Girls among adolescent girls. DESIGN Group randomized controlled trial with 12-month follow-up. SETTING Twelve secondary schools in low-income communities in the Hunter and Central Coast regions of New South Wales, Australia. PARTICIPANTS Three hundred fifty-seven adolescent girls aged 12 to 14 years. INTERVENTION A multicomponent school-based intervention program tailored for adolescent girls. The intervention was based on social cognitive theory and included teacher professional development, enhanced school sport sessions, interactive seminars, nutrition workshops, lunch-time physical activity sessions, handbooks and pedometers for self-monitoring, parent newsletters, and text messaging for social support. MAIN OUTCOME MEASURES Body mass index (BMI, calculated as weight in kilograms divided by height in meters squared), BMI z score, body fat percentage, physical activity, screen time, dietary intake, and self-esteem. RESULTS After 12 months, changes in BMI (adjusted mean difference, -0.19; 95% CI, -0.70 to 0.33), BMI z score (mean, -0.08; 95% CI, -0.20 to 0.04), and body fat percentage (mean, -1.09; 95% CI, -2.88 to 0.70) were in favor of the intervention, but they were not statistically different from those in the control group. Changes in screen time were statistically significant (mean, -30.67 min/d; 95% CI, -62.43 to -1.06), but there were no group by time effects for physical activity, dietary behavior, or self-esteem. CONCLUSIONS A school-based intervention tailored for adolescent girls from schools located in low-income communities did not significantly reduce BMI gain. However, changes in body composition were of a magnitude similar to previous studies and may be associated with clinically important health outcomes. TRIAL REGISTRATION anzctr.org.au Identifier: 12610000330044.

A randomized study of the effects of exercise training on patients with atrial fibrillation.

PubMed

Osbak, Philip Samuel; Mourier, Malene; Kjaer, Andreas; Henriksen, Jens Henrik; Kofoed, Klaus Fuglsang; Jensen, Gorm Boje

2011-12-01

Exercise training is beneficial in ischemic and congestive heart disease. However, the effect on atrial fibrillation (AF) is unknown. Forty-nine patients with permanent AF (age [mean ± SD], 70.2 ± 7.8 years; male-to-female ratio, 0.75; body mass index [mean ± SD], 29.7 ± 4.3 kg/m(2)) were randomized to 12-week aerobic exercise training or a control group. Exercise capacity, 6-minute walk test (6MWT), cardiac output, quality of life, and natriuretic peptides were measured. Cardiac output was measured at rest and during ergometer testing, and atrial natriuretic peptide and N-terminal pro-B-type natriuretic peptide were measured before and after the training period. Quality of life was evaluated using the Short-Form 36 and Minnesota Living With Heart Failure (MLHF-Q) questionnaires. Improved exercise capacity and 6MWT were observed in the active patients (P < .001), and at study end, there was a significant difference between the active patients and the controls (P = .002). Resting pulse decreased in the active patients (94.8 ± 22.4 to 86.3 ± 22.5 beats/min, P = .049) but remained unchanged in the controls. Cardiac output was unchanged from baseline to end-of-study period. The MLHF-Q score improved in the active group (21.1 ± 18.0 vs 15.4 ± 17.5, P = .03). Active patients showed progress in 3 of the 8 Short-Form 36 subscales: physical functioning (P = .02), general health perceptions (P = .001), and vitality (P = .02). Natriuretic peptides were unchanged. Twelve weeks of exercise training increased exercise capacity and 6MWT and decreased resting pulse rate significantly in patients with AF. Overall quality of life increased significantly as measured by the cardiology-related MLHF-Q. Cardiac output and natriuretic peptides were unchanged in both groups. Copyright © 2011 Mosby, Inc. All rights reserved.

A systematic review of randomized controlled trials examining the effectiveness of saffron (Crocus sativus L.) on psychological and behavioral outcomes.

PubMed

Hausenblas, Heather Ann; Heekin, Kacey; Mutchie, Heather Lee; Anton, Stephen

2015-07-01

Throughout the past three decades, increased scientific attention has been given to examining saffron's (Crocus sativus L.) use as a potential therapeutic or preventive agent for a number of health conditions, including cancer, cardiovascular disease, and depression. The purpose of this systematic review is to examine and categorize the current state of scientific evidence from randomized controlled trials (RCTs) regarding the efficacy of saffron on psychological/behavioral outcomes. Electronic and non-electronic systematic searches were conducted to identify all relevant human clinical research on saffron. The search strategy was extensive and was designed according to the "Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)." Reference lists of articles that met the inclusion criteria were searched. Only English language studies were reviewed. Saffron trials in combination with other substances and saffron safety studies were considered, in accordance with the PRISMA statement. Included studies must have a control group. Included studies must measure a physiological and/or a behavioral outcome. The methodological quality of all included studies was independently evaluated by two reviewers using the Jadad score. Mean scores and P-values of measures were compared both inter- and intra-study for each parameter (i.e., depression). Twelve studies met our inclusion criteria. These studies examined the effects of saffron on psychological/behavioral outcomes of: major depressive disorder (n=6), premenstrual syndrome (n = 1), sexual dysfunction and infertility (n=4), and weight loss/snacking behaviors (n=1). The data from these studies support the efficacy of saffron as compared to placebo in improving the following conditions: depressive symptoms (compared to anti-depressants and placebo), premenstrual symptoms, and sexual dysfunction. In addition, saffron use was also effective in reducing excessive snacking behavior. Findings from initial clinical trials suggest that saffron may improve the symptoms and the effects of depression, premenstrual syndrome, sexual dysfunction and infertility, and excessive snacking behaviors. Larger multi-site clinical trials are needed to extend these preliminary findings.

Pre-pregnancy care for women with pre-gestational diabetes mellitus: a systematic review and meta-analysis.

PubMed

Wahabi, Hayfaa A; Alzeidan, Rasmieh A; Esmaeil, Samia A

2012-09-17

Pre-gestational diabetes mellitus is associated with increased risk for maternal and fetal adverse outcomes. This systematic review was carried out to evaluate the effectiveness and safety of pre-pregnancy care in improving the rate of congenital malformations and perinatal mortality for women with pre-gestational diabetes mellitus. We searched the following databases, MEDLINE, EMBASE, WEB OF SCIENCE, Cochrane Library, including the CENTRAL register of controlled trials and CINHAL up to December 2011, without language restriction, for any pre-pregnancy care aiming at health promotion, glycemic control and screening and treatment of diabetes complications in women with type I or type II diabetes mellitus. Study design were trials (randomized and non-randomized), cohort and case-control studies. Of the 2452 title scanned 54 full papers were retrieved of those 21 studies were included in this review. Twelve cohort studies at low and medium risk of bias, with 3088 women, were included in the meta-analysis. Meta-analysis suggested that pre-pregnancy care is effective in reducing congenital malformation, Risk Ratio (RR) 0.25 (95% CI 0.16-0.37), number needed to treat (NNT) 19 (95% CI 14-24), and perinatal mortality RR 0.34 (95% CI 0.15-0.75), NNT = 46 (95% CI 28-115). Pre-pregnancy care lowers glycosylated hemoglobin A1c (HbA1c) in the first trimester of pregnancy by an average of 1.92% (95% CI -2.05 to -1.79). However women who received pre-pregnancy care were at increased risk of hypoglycemia during the first trimester of pregnancy RR 1.51 (95% CI 1.15-1.99). Pre-pregnancy care for women with pre-gestational type 1 or type 2 diabetes mellitus is effective in improving rates of congenital malformations, perinatal mortality and in reducing maternal HbA1C in the first trimester of pregnancy. Pre-pregnancy care might cause maternal hypoglycemia in the first trimester of pregnancy.

Factors related to reduction in the consumption of fast food: application of the theory-based approaches

PubMed Central

Zeinab, Jalambadani; Gholamreza, Garmaroudi; Mehdi, Yaseri; Mahmood, Tavousi; Korush, Jafarian

2017-01-01

Background The Trans-Theoretical model (TTM) and Theory of Planned Behaviour (TPB) may be promising models for understanding and predicting reduction in the consumption of fast food. The aim of this study was to examine the applicability of the Trans-Theoretical model (TTM) and the additional predictive role of the subjective norms and perceived behavioural control in predicting reduction consumption of fast food in obese Iranian adolescent girls. Materials and Methods. A cross sectional study design was conducted among twelve randomly selected schools in Sabzevar, Iran from 2015 to 2017. Four hundred eighty five randomly selected students consented to participate in the study. Hierarchical regression models used to predict the role of important variables that can influence the reduction in the consumption of fast food among students. using SPSS version 22. Results Variables Perceived behavioural control (r=0.58, P<0.001), Subjective norms (r=0.51, P<0.001), self-efficacy (r=0.49, P<0.001), decisional balance (pros) (r=0.29, P<0.001), decisional balance (cons) (r=0.25, P<0.001), stage of change (r=0.38, P<0.001), were significantly and positively correlated while experiential processes of change (r=0.08, P=0.135) and behavioural processes of change (r=0.09, P=0.145), were not significant. Conclusions The study demonstrated that the TTM (except the experiential and behavioural processes of change) focusing on the perceived behavioural control and subjective norms are useful models for reduction in the consumption of fast food. Significance for public health The Ministries of Education and Public Health should cooperate in supporting the below-mentioned formal and non-formal school, family and community nutritional education and activities. Lastly, the Ministry of Public Health should conduct programmes with restaurant owners on healthy Iranian food and its hygienic presentation and promotion, to enhance their ability to compete with fast-food restaurants. PMID:29071252

Improving attitudes towards children with disabilities in a school context: a cluster randomized intervention study.

PubMed

Godeau, Emmanuelle; Vignes, Céline; Sentenac, Mariane; Ehlinger, Virginie; Navarro, Félix; Grandjean, Hélène; Arnaud, Catherine

2010-10-01

although inclusive education of disabled children is now an accepted practice, it is often challenged by negative peer attitudes. We undertook an interventional study aimed at improving students' attitudes towards their disabled peers. the participants were students from the 7th grade of twelve paired schools (1509 students from 62 classes; age 12-13y), randomly allocated to an intervention group (205 males, 285 females) or a control group (132 males, 165 females). The intervention consisted of a mandatory comprehensive educational project on disability. The Chedoke-McMaster Attitudes Towards Children with Handicaps Scale (CATCH) was used to assess children's attitudes before (T0) and after (T1) intervention. The hierarchical structure of the data was taken into account by adjusting standard deviations and using linear multilevel models. seven hundred and eighty-four students had at least one score on the three domains (cognitive, affective, behavioural) of the CATCH at T0 and T1. The final scores were higher than baseline scores (total scores, intervention group: baseline score 25.6 (SD=5.4), final score 26.8 (5.9), p<0.001; baseline 25.2 (5.4), final 26.0 (5.7), p<0.009) with no significant difference between the intervention and control groups. Individual score changes over time were associated with baseline score (p<0.001 for total and all sub-scores). Lower improvement in attitudes was found in students from schools with special units for their peers with cognitive impairment for total (p=0.013), affective (p<0.001), and behavioural (p=0.001) scores, while higher improvement existed for the cognitive domain (p=0.029). although we found no effect of our intervention, we found an improvement in attitudes in the intervention and control groups that could be a result of the nature of the scales and questionnaires the students had to complete before the intervention.

Effect of occlusal splint therapy on maximum bite force in individuals with moderate to severe attrition of teeth.

PubMed

Jain, Veena; Mathur, Vijay Prakash; Abhishek, Kumar; Kothari, Mohit

2012-10-01

The purpose of the pilot study was to determine the effect of restoring lost occlusal vertical dimension (OVD) due to attrition on maximum bite force in humans. A total of 124 subjects in age range of 25-40 years, with moderate to severe attrition, having full complement of teeth were screened according to inclusion and exclusion criteria. After consent, occlusal vertical dimension was assessed by employing mechanical and physiological methods in the experimental group and a maxillary canine guided hard splint was fabricated for each subjects fulfilling inclusion criteria and with positive consent (78). Bite force in experimental group was measured before, immediately after delivery of splint and subsequently at an interval of four, eight, and twelve weeks. Due loss during follow up, only 50 subjects could be available for bite force recording till 12 weeks. Bite force of age, gender, height and weight matched controls with no signs of attrition was also measured for comparison. Bite force of the experimental group was found to be significantly less than the matched controls (P=0.000) initially. After delivery of splint, bite force values increased progressively till twelve weeks. However comparison of bite force values of experimental group with control group showed no significant difference at end of eight (P=0.008) and twelve weeks (P=0.162). It was concluded that maximum bite force increases with restoration of lost vertical using splint therapy. A time period of 8-12 weeks is required to restore the maximum bite force value approximately similar to matched controls. Copyright © 2012 Japan Prosthodontic Society. Published by Elsevier Ltd. All rights reserved.

The effect of sleep deprivation on BOLD activity elicited by a divided attention task.

PubMed

Jackson, Melinda L; Hughes, Matthew E; Croft, Rodney J; Howard, Mark E; Crewther, David; Kennedy, Gerard A; Owens, Katherine; Pierce, Rob J; O'Donoghue, Fergal J; Johnston, Patrick

2011-06-01

Sleep loss, widespread in today's society and associated with a number of clinical conditions, has a detrimental effect on a variety of cognitive domains including attention. This study examined the sequelae of sleep deprivation upon BOLD fMRI activation during divided attention. Twelve healthy males completed two randomized sessions; one after 27 h of sleep deprivation and one after a normal night of sleep. During each session, BOLD fMRI was measured while subjects completed a cross-modal divided attention task (visual and auditory). After normal sleep, increased BOLD activation was observed bilaterally in the superior frontal gyrus and the inferior parietal lobe during divided attention performance. Subjects reported feeling significantly more sleepy in the sleep deprivation session, and there was a trend towards poorer divided attention task performance. Sleep deprivation led to a down regulation of activation in the left superior frontal gyrus, possibly reflecting an attenuation of top-down control mechanisms on the attentional system. These findings have implications for understanding the neural correlates of divided attention and the neurofunctional changes that occur in individuals who are sleep deprived.

Exposure of healthy subjects with emissions from a gas metal arc welding process: part 3--biological effect markers and lung function.

PubMed

Brand, P; Bischof, K; Siry, L; Bertram, J; Schettgen, T; Reisgen, U; Kraus, T; Gube, M

2013-01-01

Metal active gas welding (MAG) is a widely-used welding technique resulting in high emissions of welding fume particles. This study investigated whether short-term exposure to these fume particles results in changes in lung function and early stages of inflammatory reactions. Twelve healthy, young male subjects were exposed to MAG fumes for 6 h with three different exposure concentrations in a three-fold cross-over study design. Exposure was performed in the "Aachen Workplace Simulation Laboratory" under controlled conditions with constant fume concentration. Fume concentrations were 0, 1, and 2.5 mg m(-3) in randomized order. Before and after each exposure, spirometry, and impulse oscillometry were performed and breath condensate samples were collected in order to quantify inflammatory markers like Nitrate, Nitrite, Nitrotyrosine, Hydroxyprolin and Malondialdehyde. A significant dependency on the exposure concentration could not be established for any of the endpoint parameters. In healthy, young subjects neither changes in spirometry nor changes in inflammatory markers measured in exhaled breath condensate could be detected after short-term exposure.

Self-management improvement program combined with community involvement in Thai hypertensive population: an action research.

PubMed

Srichairattanakull, Jeamjai; Kaewpan, Wonpen; Powattana, Arpaporn; Pichayapinyo, Panan

2014-04-01

To investigate the effectiveness of a program that utilizes community involvement to improve the self-management strategies among people living with hypertension. Forty-four subjects, aged 35 to 59-year-old, with hypertension in Nakhon Pathom Province, Thailand, were randomly allocated to either an experimental group (n = 22) or a control group (n = 20). The experimental group attended a program to improve self-management methods based on social cognitive theory (SCT). The program lasted 12 weeks, consisted of 1 1/2 hours meeting once a week, including group meetings and home visit monitoring. Mann-Whitney U test and Friedman test were employed to analyze the program's effectiveness. After the program, the mean rank of the perceived self-efficacy for the self-management strategies was statistically different between the two groups (p = 0.023). In the experimental group, after the twelve week, the mean rank of perceived self-efficacy and outcome expectancy increased and diastolic blood pressure decreased after the eight week. The program applied social cognitive theory (SCT) to promote self-management techniques, increased the health promoting behavior among hypertensive people.

Twelve tips for postgraduate or undergraduate medics building a basic microsurgery simulation training course.

PubMed

Mason, Katrina A; Theodorakopoulou, Evgenia; Pafitanis, Georgios; Ghanem, Ali M; Myers, Simon R

2016-09-01

Microsurgery is used in a variety of surgical specialties, including Plastic Surgery, Maxillofacial Surgery, Ophthalmic Surgery, Otolaryngology and Neurosurgery. It is considered one of the most technically challenging fields of surgery. Microsurgical skills demand fine, precise and controlled movements, and microsurgical skill acquisition has a steep initial learning curve. Microsurgical simulation provides a safe environment for skill acquisition before operating clinically. The traditional starting point for anyone wanting to pursue microsurgery is a basic simulation training course. We present twelve tips for postgraduate and undergraduate medics on how to set up and run a basic ex-vivo microsurgery simulation training course suitable for their peers.

Sex differences in response to targeted kyphosis specific exercise and posture training in community-dwelling older adults: a randomized controlled trial.

PubMed

Katzman, Wendy B; Parimi, Neeta; Gladin, Amy; Poltavskiy, Eduard A; Schafer, Anne L; Long, Roger K; Fan, Bo; Wong, Shirley S; Lane, Nancy E

2017-12-04

Hyperkyphosis, an excessive anterior curvature in the thoracic spine, is associated with reduced health status in older adults. Hyperkyphosis is highly prevalent, more common in older women than men. There is no standard intervention to reduce age-related hyperkyphosis. Sex differences in response to a kyphosis-specific exercise intervention are not known. We conducted a randomized controlled trial of a targeted kyphosis-specific exercise and postural training program on the primary outcome Cobb angle of kyphosis, and investigated whether the magnitude of change differed between men and women. One hundred twelve participants aged ≥60 years with kyphosis ≥40° were enrolled and randomized to exercise or waitlist control, and 101 participants had analyzable baseline and follow-up radiographs for Cobb angle measurements. A group intervention including 10 participants per group was delivered by a physical therapist, 1-h, twice a week for 3-months. Controls were placed on a waitlist for 3 months before receiving a delayed intervention. Primary outcome was change from baseline to 3-months in Cobb angle measured from standing lateral spine radiographs. Secondary outcomes included change over 3-months in kyphometer-measured kyphosis, physical function and quality of life. Groups were combined for analysis after both received the intervention, and sex differences in response to the intervention were tested with ANOVA. Participants (60 women, 41 men) were 70.0 (SD = 5.7) years old with mean Cobb angle 55.9 (SD = 12.2) degrees at baseline. The active group had higher baseline modified Physical Performance Test scores than control, p = 0.03. Men had greater baseline kyphometer-measured kyphosis, p = 0.09, and higher bone mineral density (BMD), spine strength, more vertebral fractures and diffuse idiopathic skeletal hyperostosis (DISH) than women, p ≤ 0.01. There was no statistically significant difference between groups in change in Cobb at 3-months, p = 0.09, however change in kyphometer-measured kyphosis differed by 4.8 (95% CI:-6.8,-2.7) degrees, p < 0.001, favoring the active group. There were no differences between men and women in change in either kyphosis measurement after intervention, p > 0.1. A 3-month targeted spine strengthening exercise and posture training program reduced kyphometer-measured, but not radiographic-measured kyphosis. Despite sex differences in baseline kyphosis, BMD, spine strength, fractures and DISH, sex did not affect treatment response. ClinicalTrials.gov Identifier: NCT01766674.

Comparison of packing material in an animal model of middle ear trauma.

PubMed

Perez, Enrique; Hachem, Ralph Abi; Carlton, Daniel; Bueno, Isabel; Vernon, Stephen; Van De Water, Thomas R; Angeli, Simon I

2016-01-01

To compare the performance of absorbable gelatin sponge (AGS) with polyurethane foam (PUF) as middle ear packing material after mucosal trauma. Using a randomized, controlled and blinded study design fifteen guinea pigs underwent middle ear surgery with mucosal trauma performed on both ears. One ear was packed with either PUF or AGS while the contralateral ear remained untreated and used as non-packed paired controls. Auditory brainstem response (ABR) thresholds were measured pre-operatively and repeated at 1, 2, and 6weeks postoperatively. Histological analysis of middle ear mucosa was done in each group to evaluate the inflammatory reaction and wound healing. Another eighteen animals underwent middle ear wounding and packing in one ear while the contralateral ear was left undisturbed as control. Twelve guinea pigs were euthanized at 2weeks postoperatively, and six were euthanized at 3days post-operatively. Mucosal samples were collected for analysis of TGF-β1 levels by enzyme-linked immunosorbent assay. ABR recordings demonstrate that threshold level changes from baseline were minor in PUF packed and control ears. Threshold levels were higher in the AGS packed ears compared with both control and PUF packed ears for low frequency stimuli. Histological analysis showed persistence of packing material at 6weeks postoperatively, inflammation, granulation tissue formation, foreign body reaction and neo-osteogenesis in both AGS and PUF groups. TGF-β1 protein levels did not differ between groups. PUF and AGS packing cause inflammation and neo-osteogenesis in the middle ear following wounding of the mucosa and packing. Copyright © 2016 Elsevier Inc. All rights reserved.

Cognitive demand and predictive adaptational responses in dynamic stability control.

PubMed

Bohm, Sebastian; Mersmann, Falk; Bierbaum, Stefanie; Dietrich, Ralf; Arampatzis, Adamantios

2012-09-21

We studied the effects of a concurrent cognitive task on predictive motor control, a feedforward mechanism of dynamic stability control, during disturbed gait in young and old adults. Thirty-two young and 27 elderly male healthy subjects participated and were randomly assigned to either control or dual task groups. By means of a covered exchangeable element the surface condition on a gangway could be altered to induce gait perturbations. The experimental protocol included a baseline on hard surface and an adaptation phase with twelve trials on soft surface. After the first, sixth and last soft surface trial, the surface condition was changed to hard (H1-3), to examine after-effects and, thus, to quantify predictive motor control. Dynamic stability was assessed using the 'margin of stability (MoS)' as a criterion for the stability state of the human body (extrapolated center of mass concept). In H1-3 the young participants significantly increased the MoS at touchdown of the disturbed leg compared to baseline. The magnitude and the rate of these after-effects were unaffected by the dual task condition. The old participants presented a trend to after-effects (i.e., increase of MoS) in H3 but only under the dual task condition.In conclusion, the additional cognitive demand did not compromise predictive motor control during disturbed walking in the young and old participants. In contrast to the control group, the old dual task group featured a trend to predictive motor adjustments, which may be a result of a higher state of attention or arousal due to the dual task paradigm. Copyright © 2012 Elsevier Ltd. All rights reserved.

FLUID/MASHOV--A CAI System Based on Games, Dialogue, and Feedback.

ERIC Educational Resources Information Center

Regev, Joseph

1980-01-01

A master program to manage instruction and generate the necessary control cards was designed to both teach thinking skills and assist the teacher in assessing the student's thought processes. Twelve references are cited. (MER)

Patient Engagement Programs for Recognition and Initial Treatment of Depression in Primary Care: A Randomized Trial

PubMed Central

Kravitz, Richard L.; Franks, Peter; Feldman, Mitchell D.; Tancredi, Daniel J.; Slee, Christina A.; Epstein, Ronald M.; Duberstein, Paul R.; Bell, Robert A.; Jackson-Triche, Maga; Paterniti, Debora A.; Cipri, Camille; Iosif, Ana-Maria; Olson, Sarah; Kelly-Reif, Steven; Hudnut, Andrew; Dvorak, Simon; Turner, Charles; Jerant, Anthony

2015-01-01

Importance Interventions encouraging primary care patients’ engagement with their clinicians to address depression could improve outcomes but foster unnecessary treatment. Objective Determine whether a depression engagement video (DEV) or a tailored interactive multimedia computer program (IMCP) improves initial depression care without increasing unnecessary anti-depressant prescribing. Design Randomized controlled trial comparing three interventions (DEV, IMCP, and control) conducted in two patients groups (depressed, defined by a Patient Health Questionnaire [PHQ]-9 score ≥5, and non-depressed [PHQ-9<5]) conducted between June 2010 and March 2012. Setting Primary care offices at 7 sites in 2 cities. Participants Depressed (N=559) and non-depressed (N=308) adult patients of 135 primary care clinicians. Intervention(s) DEV targeted to gender and income; IMCP tailored to individual patient characteristics; a sleep hygiene video (control). Main Outcome Measure(s) Depressed patients: composite measure of antidepressant recommendation and/or mental health referral (primary outcome); 12-week mental health, measured by the PHQ-8 (secondary outcome). Non- depressed patients: clinician-reported prescribing and patient-reported antidepressant recommendation (primary outcomes, pre-specified 3.5% non-inferiority margins). Results Depressed patients: composite care outcome rates were 18%, 26%, and 16% respectively in the DEV, IMCP, and control groups (cluster-adjusted DEV-control difference = 1.1% [95% CI −6.7 to 8.9, P=.79]; IMCP-control = 9.9% [95% CI 1.6 to 18.2, P=.02]). Twelve-week PHQ-8 effects were not significant: DEV- control = −0.2 points (95% CI −1.2 to 0.8); IMCP – control = 0.9 (95% CI −0.1 to 1.9). Non-depressed patients: clinician-reported antidepressant prescribing in the DEV and IMCP groups was non-inferior to control (DEV-control = −2.2%, 90% CI −8.0 to 3.498, non-inferiority (NI) P=.0499; IMCP-control = −3.3%, 90% CI −9.1 to 2.4, NI P=.02); patient-reported antidepressant recommendation did not achieve non-inferiority: DEV-control = 0.9% (90% CI −4.9 to 6.7; NI P=.23); IMCP-control = 0.3% (90% CI −5.1 to 5.7; NI P=.16). Conclusions and Relevance A tailored IMCP increased antidepressant recommendation and/or mental health referral among depressed patients but had no effect on 12-week mental health. The possibility that the IMCP and DEV increased patient-reported antidepressant recommendations among non-depressed patients could not be excluded. Further research is needed on the benefits and harms of these interventions. PMID:24193079

Emetic and Electric Shock Alcohol Aversion Therapy: Six- and Twelve-Month Follow-Up.

ERIC Educational Resources Information Center

Cannon, Dale S.; Baker, Timothy B.

1981-01-01

Follow-up data are presented for 6- and 12-months on male alcoholics (N=20) who received either a multifaceted inpatient alcoholism treatment program alone (controls) or emetic or shock aversion therapy in addition to that program. Both emetic and control subjects compiled more days of abstinence than shock subjects. (Author)

Phonation Interval Modification and Speech Performance Quality during Fluency-Inducing Conditions by Adults Who Stutter

ERIC Educational Resources Information Center

Ingham, Roger J.; Bothe, Anne K.; Wang, Yuedong; Purkhiser, Krystal; New, Anneliese

2012-01-01

Purpose: To relate changes in four variables previously defined as characteristic of normally fluent speech to changes in phonatory behavior during oral reading by persons who stutter (PWS) and normally fluent controls under multiple fluency-inducing (FI) conditions. Method: Twelve PWS and 12 controls each completed 4 ABA experiments. During A…

Motivational interviews to improve contraceptive use in populations at high risk of unintended pregnancy: a systematic review and meta-analysis.

PubMed

Wilson, Amie; Nirantharakumar, Krishnarajah; Truchanowicz, Ewa G; Surenthirakumaran, Rajendra; MacArthur, Christine; Coomarasamy, Arri

2015-08-01

Effective contraceptive use has the potential to prevent around 230 million births each year. An estimated 222 million women want to delay pregnancy or cease childbearing, but are not actively using contraception. Lack of education is a known barrier for effective contraceptive use. Motivational interviews are presumed to improve effective contraceptive use, but studies to date report varied findings. Some studies demonstrate an improvement and others report no effect. A systematic review of evidence on the impact of motivational interviews on contraceptive use in women of childbearing age was carried out using MEDLINE, EMBASE, BNI, Cochrane library, CINHAL, African Index Medicus, Web of Science, the Reproductive Health Library, and the Science Citation Index (inception-January 2013) without language restriction. Search terms included 'motivational interview* AND contraception OR family planning OR maternal OR pregnancy'. Randomised controlled trials comparing the effect of motivational interviews with standard practice on effective contraception use in women of reproductive age were included. The outcome measures were use of effective contraception or use of high-level contraception, and subsequent births or pregnancies. The random effects model was used to pool the risk ratios from individual studies. Eight randomised controlled trials were included in the review with a total of 3424 women at high risk of pregnancy. Meta-analysis showed an increase in effective contraceptive use with motivational interviews when compared with control (RR 1.32 95%CI 1.11, 1.56: P=0.002) in the period of zero to four months post intervention. No difference in effective contraceptive use was shown at four to eight months (RR 1.10, 95%CI 0.93, 1.32: P=0.27), and between eight to twelve months (RR 1.18 95%CI 0.96, 1.46: P=0.12). No evidence of effect in the reduction of subsequent pregnancies or births at twelve to twenty-four months was seen with motivational interviews (RR 0.80 95%CI 0.51, 1.26: P=0.34). Motivational interviews significantly increase effective contraceptive use immediately after and up to four months post-intervention. The effect without reinforcement is short lasting as no evidence of effect is seen after four months post-intervention. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

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.

PubMed

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 addition of alpha tocopherol did not affect toxicity.

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

PubMed Central

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 α tocopherol did not affect toxicity. PMID:19401528

The effectiveness of Grief-Help, a cognitive behavioural treatment for prolonged grief in children: study protocol for a randomised controlled trial.

PubMed

Spuij, Mariken; Prinzie, Peter; Dekovic, Maja; van den Bout, Jan; Boelen, Paul A

2013-11-20

There is growing recognition of a syndrome of disturbed grief referred to as prolonged grief disorder (PGD). PGD is mostly studied in adults, but clinically significant PGD symptoms have also been observed in children and adolescents. Yet, to date no effective treatment for childhood PGD exists. The aims of this study are: (1) to investigate the effectiveness of Grief-Help, a nine-session cognitive-behavioural treatment for childhood PGD, combined with five sessions of parental counselling, immediately after the treatment and at three, six and twelve months follow-up; (2) to examine tentative mediators of the effects of Grief-Help, (i.e., maladaptive cognitions and behaviours and positive parenting), and (3) to determine whether demographic variables, child personality, as well as symptoms of PGD, anxiety, and depression in parents moderate the treatment effectiveness. We will conduct a Randomised Controlled Trial (RCT) in which 160 children and adolescents aged 8-18 years are randomly allocated to cognitive behavioural Grief-Help or to a supportive counselling intervention; both treatments are combined with five sessions of parental counselling. We will recruit participants from clinics for mental health in the Netherlands. The primary outcome measure will be the severity of Prolonged Grief Disorder symptoms according to the Inventory of Prolonged Grief for Children (IPG-C). Secondary outcomes will include PTSD, depression and parent-rated internalizing and externalizing problems. Mediators like positive parenting and maladaptive cognitions and behaviours will be identified. We will also examine possible moderators including demographic variables (e.g. time since loss, cause of death), psychopathology symptoms in parents (PGD, anxiety and depression) and child personality. Assessments will take place in both groups at baseline, after the treatment-phase and three, six and twelve months after the post-treatment assessment. We aim to contribute to the improvement of mental health care for children and adolescents suffering from loss. By comparing Grief-Help with supportive counselling, and by investigating mediators and moderators of its effectiveness we hope to provide new insights in the effects of interventions for bereaved children, and their mechanisms of change. Netherlands Trial Register NTR3854.

Twelve weeks of dance exergaming in overweight and obese adolescent girls: Transfer effects on physical activity, screen time, and self-efficacy.

PubMed

Staiano, Amanda E; Beyl, Robbie A; Hsia, Daniel S; Katzmarzyk, Peter T; Newton, Robert L

2017-03-01

Given the low levels of physical activity (PA) among adolescent girls in the US, there is a need to identify tools to motivate increased PA. Although there is limited evidence that adolescents transfer PA from one context to another context, exergames (i.e., video games that require gross motor activity) may act as a gateway to promote overall PA outside of game play. The purpose of this study was to examine potential transfer effects (i.e., influences on external behaviors and psychological constructs) of a 12-week exergaming intervention on adolescent girls' PA, screen-time, and self-efficacy towards PA, as well as the intrinsic motivation of exergaming. Participants were 37 girls aged 14-18 years (65% African American, 35% White) who were overweight or obese (body mass index ≥ 85th percentile) and were recruited from the community via school, physicians, news media, and social media sites. Adolescents were randomly assigned to a 12-week group exergaming intervention (thirty-six 60 min sessions of group-based dance exergaming in a research laboratory using Kinect for Xbox 360) or to a no-treatment control group. Outcome variables included objectively measured PA (total) and self-reported leisure-time PA (discretionary time only) 1-week before vs . 1-week after the intervention; selected type and intensity of PA when placed in a gym setting for 30 min ("cardio free choice"); screen-time; self-efficacy towards PA; and intrinsic motivation towards exergaming. Attendance to the exergaming sessions was high (80%). Compared to the control group, the intervention group self-reported an increase in PA ( p = 0.035) and fewer hours watching TV/videos ( p = 0.01) after the intervention, but there were no significant differences in sedentary, light, moderate, or vigorous PA measured by accelerometry. The intervention group significantly improved self-efficacy towards PA ( p = 0.028). The intervention group highly rated intrinsic motivation towards exergaming. Twelve weeks of exergaming was associated with positive impacts on adolescent girls' self-reported PA, television viewing, self-efficacy, and intrinsic motivation. Future research is warranted to leverage exergames as an enjoyable, motivating, and effective PA tool.

Capacity-building and clinical competence in infectious disease in Uganda: a mixed-design study with pre/post and cluster-randomized trial components.

PubMed

Weaver, Marcia R; Crozier, Ian; Eleku, Simon; Makanga, Gyaviira; Mpanga Sebuyira, Lydia; Nyakake, Janepher; Thompson, MaryLou; Willis, Kelly

2012-01-01

Best practices for training mid-level practitioners (MLPs) to improve global health-services are not well-characterized. Two hypotheses were: 1) Integrated Management of Infectious Disease (IMID) training would improve clinical competence as tested with a single arm, pre-post design, and 2) on-site support (OSS) would yield additional improvements as tested with a cluster-randomized trial. Thirty-six Ugandan health facilities (randomized 1∶1 to parallel OSS and control arms) enrolled two MLPs each. All MLPs participated in IMID (3-week core course, two 1-week boost sessions, distance learning). After the 3-week course, OSS-arm trainees participated in monthly OSS. Twelve written case scenarios tested clinical competencies in HIV/AIDS, tuberculosis, malaria, and other infectious diseases. Each participant completed different randomly-assigned blocks of four scenarios before IMID (t0), after 3-week course (t1), and after second boost course (t2, 24 weeks after t1). Scoring guides were harmonized with IMID content and Ugandan national policy. Score analyses used a linear mixed-effects model. The primary outcome measure was longitudinal change in scenario scores. Scores were available for 856 scenarios. Mean correct scores at t0, t1, and t2 were 39.3%, 49.1%, and 49.6%, respectively. Mean score increases (95% CI, p-value) for t0-t1 (pre-post period) and t1-t2 (parallel-arm period) were 12.1 ((9.6, 14.6), p<0.001) and -0.6 ((-3.1, +1.9), p = 0.647) percent for OSS arm and 7.5 ((5.0, 10.0), p<0.001) and 1.6 ((-1.0, +4.1), p = 0.225) for control arm. The estimated mean difference in t1 to t2 score change, comparing arm A (participated in OSS) vs. arm B was -2.2 ((-5.8, +1.4), p = 0.237). From t0-t2, mean scores increased for all 12 scenarios. Clinical competence increased significantly after a 3-week core course; improvement persisted for 24 weeks. No additional impact of OSS was observed. Data on clinical practice, facility-level performance and health outcomes will complete assessment of overall impact of IMID and OSS. ClinicalTrials.gov NCT01190540.

The influence of different soft-tissue grafting procedures at single implant placement on esthetics: A randomized controlled trial.

PubMed

Zuiderveld, Elise G; Meijer, Henny J A; Vissink, Arjan; Raghoebar, Gerry M

2018-05-13

Soft tissue grafting to thicken the soft tissue around dental implants was proposed to ameliorate the esthetic outcome. Traditionally, connective tissue is used as a grafting material, but a xenogeneic collagen matrix was introduced as an alternative to reduce patient morbidity. Sixty patients randomly received either no graft (n = 20, NG group), a connective tissue graft (n = 20, CTG group) or a xenogeneic collagen matrix (n = 20, XCM group) when placing an implant in a preserved alveolar ridge. Changes in mid-buccal mucosal level (MBML) at one (T 1 ) and twelve (T 12 ) months after final implant crown placement were compared to the pre-extraction situation. Additionally, esthetics, marginal bone level, clinical peri-implant parameters and patient satisfaction were assessed. At T 12 , mean changes in MBML were -0.48±1.5 mm, -0.04±1.1 mm and -0.17±1.3 mm in the NG, CTG and XCM groups (p = 0.56), respectively. Regarding the other outcome variables, no significant inter-group differences were observed. Soft tissue grafting at single implant placement in preserved alveolar ridges does not result in a better esthetic outcome or in better peri-implant health and should not be considered as a standard procedure. This article is protected by copyright. All rights reserved. © 2018 American Academy of Periodontology.

Anti-alpha interferon immunization: safety and immunogenicity in asymptomatic HIV positive patients at high risk of disease progression.

PubMed

Gringeri, A; Santagostino, E; Mannucci, P M; Siracusano, L; Marinoni, A; Criscuolo, M; Carcagno, M; Fall, L S; M'Bika, J P; Bizzini, B

1995-05-01

A randomized, placebo-controlled trial was designed to evaluate safety and immunogenicity of an anti-cytokine vaccine in high risk HIV-positive patients. This strategy was aimed to modulate the impaired cytokine regulation in AIDS. Twelve asymptomatic patients on antiretroviral therapy for at least 1 year and with CD4 cell counts between 100-300/mm3 were randomized to receive adjuvanted formol-inactivated interferon alpha-2a (IFN alpha) and continue the current antiretroviral treatment, whatever it was, or to receive the adjuvant alone and the current antiretroviral treatment. All patients received 4 i.m. injections monthly, followed by booster injections every 3 months. Clinical status, immunology and virology were monitored. Immune response to vaccination was evaluated in term of antibody detection (ELISA) and serum anti-IFN alpha neutralizing capacity. Only local discomfort and transient fever were reported. All vaccines except one showed increased levels of anti-IFN alpha Abs and developed serum IFN alpha neutralizing capacity. Viral load did not increase in vaccinees while it remained unchanged or even increased in placebo-treated patients. None of them showed HIV-related symptoms and all had their CD4 cell counts stabilized over 18 months, whereas 2 placebo-treated patients developed full-blow AIDS. In conclusion, anti-IFN alpha vaccine was safe and immunogenic. Stable clinical and immunological status over 18 months was observed in vaccinees coupled to increased serum IFN alpha neutralizing capacity.

Equivalent correction in scarf and chevron osteotomy in moderate and severe hallux valgus: a randomized controlled trial.

PubMed

Deenik, Axel; van Mameren, Henk; de Visser, Enrico; de Waal Malefijt, Maarten; Draijer, Frits; de Bie, Rob

2008-12-01

Chevron osteotomy is a widely accepted osteotomy for correction of hallux valgus.(18) Algorithms were developed to overcome the limitations of distal osteotomies. Scarf osteotomy has become popular as a versatile procedure that should be able to correct most cases of acquired hallux valgus. The purpose of this study was to evaluate whether patients with moderate or severe hallux valgus have better correction with a scarf osteotomy as compared to chevron osteotomy. After informed consent, 136 feet in 115 patients were randomized to 66 scarf and 70 chevron osteotomies. Deformities of patients were classified as mild, moderate and severe according to IMA, and both groups were compared with independent t-tests. The results were measured using radiographic HVA, IMA and DMAA measurements. There were no statistical differences in HVA, IMA and DMAA between scarf and chevron osteotomy in mild to moderate hallux valgus. In severe hallux valgus, chevron osteotomy corrected HVA better than scarf osteotomy, although this group consisted of twelve patients only. Five patients in the chevron group and seven in the scarf group developed recurrent subluxation of the metatarsophalangeal joint. In patients with moderate and severe hallux valgus, the results of chevron osteotomy were at least as effective as a scarf osteotomy. Recurrent subluxation of the first metatatarsophalangeal joint was the main cause for insufficient correction. We favor the chevron osteotomy because it is less invasive, without sacrificing correction of HVA and IMA.

Effects of atypical antipsychotic drugs on QT interval in patients with mental disorders

PubMed Central

Aronow, Wilbert S.

2018-01-01

Background Drug-induced QT prolongation is associated with higher risk of cardiac arrhythmias and cardiovascular mortality. We investigated the effects of atypical antipsychotic drugs on QT interval in children and adults with mental disorders. Methods We conducted random-effects direct frequentist meta-analyses of aggregate data from randomized controlled trials (RCT) and appraised the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. Our search in PubMed, EMBASE, the Cochrane Library, clinicaltrials.gov, and PharmaPendium up to October 2017 identified studies that examined aripiprazole, quetiapine, risperidone, olanzapine, ziprasidone and brexpiprazole. Results Low quality evidence suggests that aripiprazole (four meta-analyses and twelve RCTs), brexpiprazole (one systematic review and four RCTs) or olanzapine (five meta-analyses and twenty RCTs) do not increase QT interval. Low quality evidence suggests that ziprasidone (five meta-analyses and 11 RCTs) increases QT interval and the rates of QT prolongation while risperidone (four meta-analyses, 70 RCTs) and quetiapine (two meta-analyses and seven RCTs) are associated with QT prolongation and greater odds of torsades de pointes ventricular tachycardia especially in cases of drug overdose. Conclusions The main conclusion of our study is that in people with mental disorders and under treatment with atypical antipsychotic drugs, in order to avoid QT prolongation and reduce the risk of ventricular tachycardia clinicians may recommend aripiprazole, brexpiprazole or olanzapine in licensed doses. Long-term comparative safety needs to be established. PMID:29862236

Combined caffeine and bright light reduces dangerous driving in sleep-deprived healthy volunteers: a pilot cross-over randomised controlled trial.

PubMed

Hartley, S L; Barbot, F; Machou, M; Lejaille, M; Moreau, B; Vaugier, I; Lofaso, F; Quera-Salva, M A

2013-06-01

To explore the effects of caffeine and bright light therapy on simulated nighttime driving in sleep-deprived healthy volunteers. Twelve male healthy volunteers aged 20 to 50 years participated in a randomized cross-over study of simulated nighttime driving at a sleep laboratory, followed by recovery sleep with polysomnography at home. The volunteers received variable combinations of caffeine 200mg (C+), caffeine placebo (C-), bright light 10,000 lux (L+), and bright light placebo<50 lux (L-), in four sessions (C+L+, C+L-, C-L+, C-L-), in random order with a wash-out period of 7 days. Treatments were given at 1 a.m. and testing was performed at 1:30 a.m., 3 a.m., 4 a.m., and 6 a.m. Lane drifting was the primary outcome measure. Other measures were reaction times, self-rated fatigue, sleepiness and recovery sleep. Without treatment, lane drifting increased throughout the night, and objective and subjective vigilance declined. Paired comparisons showed that lane drifting was significantly worse at 6 a.m. and at 4 a.m. than at 1:30 a.m. There was a global treatment effect on lane drifting. Lane drifting at 6 a.m. was significantly decreased with C+L+ compared to C-L-. Bright light therapy combined with caffeine administered at 1 a.m. decreased lane drifting by healthy volunteers during simulated nighttime driving. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

A sorrow shared is a sorrow halved? A three-arm randomized controlled trial comparing internet-based clinician-guided individual versus group treatment for social anxiety disorder.

PubMed

Schulz, Ava; Stolz, Timo; Vincent, Alessia; Krieger, Tobias; Andersson, Gerhard; Berger, Thomas

2016-09-01

A growing body of evidence suggests that internet-based cognitive behavioural treatments (ICBT) are effective to treat social anxiety disorder (SAD). Whereas the efficacy of clinician-guided ICBT has been established, ICBT in a group format has not yet been systematically investigated. This three-arm RCT compared the efficacy of clinician-guided group ICBT (GT) with clinician guided individual ICBT (IT) and a wait-list (WL). A total of 149 individuals meeting the diagnostic criteria for SAD were randomly assigned to one of three conditions. Primary endpoints were self-report measures of SAD and diagnostic status taken at baseline, after the twelve-week intervention and at six-month follow-up. Secondary endpoints were symptoms of depression, interpersonal problems and general symptomatology. At post-treatment, both active conditions showed superior outcome regarding SAD symptoms (GT vs. WL: d = 0.84-0.74; IT vs. WL: d = 0.94-1.22). The two active conditions did not differ significantly in symptom reduction (d = 0.12-0.26, all ps > 0.63), diagnostic response rate or attrition. Treatment gains were maintained at follow-up. The group format reduced weekly therapist time per participant by 71% (IT: 17 min, GT: 5 min). Findings indicate that a clinician-guided group format is a promising approach in treating SAD. Copyright © 2016 Elsevier Ltd. All rights reserved.

Vehicle Steering control: A model of learning

NASA Technical Reports Server (NTRS)

Smiley, A.; Reid, L.; Fraser, M.

1978-01-01

A hierarchy of strategies were postulated to describe the process of learning steering control. Vehicle motion and steering control data were recorded for twelve novices who drove an instrumented car twice a week during and after a driver training course. Car-driver describing functions were calculated, the probable control structure determined, and the driver-alone transfer function modelled. The data suggested that the largest changes in steering control with learning were in the way the driver used the lateral position cue.

Stochastic modeling of a serial killer

PubMed Central

Simkin, M.V.; Roychowdhury, V.P.

2014-01-01

We analyze the time pattern of the activity of a serial killer, who during twelve years had murdered 53 people. The plot of the cumulative number of murders as a function of time is of “Devil’s staircase” type. The distribution of the intervals between murders (step length) follows a power law with the exponent of 1.4. We propose a model according to which the serial killer commits murders when neuronal excitation in his brain exceeds certain threshold. We model this neural activity as a branching process, which in turn is approximated by a random walk. As the distribution of the random walk return times is a power law with the exponent 1.5, the distribution of the inter-murder intervals is thus explained. We illustrate analytical results by numerical simulation. Time pattern activity data from two other serial killers further substantiate our analysis. PMID:24721476

AXAF optical technology analysis. [effects of alignment figure errors on the performance of grazing incidence telescopes

NASA Technical Reports Server (NTRS)

Korsch, D.

1979-01-01

A grazing incidence telescope with six nested subsystems is investigated through the effects of misalignment and surface deformations on it's image quality. The axial rms-spot size serves as measure for the image quality. The surface deformations are simulated by ellipsoidal and sinusoidal deviation elements. Each type of defect is analyzed in the single two-element system. The full nested system is then analyzed in the presence of all possible defects on all twelve elements, whereby the magnitude of the defects is randomized within a given upper limit.

Identification of extended spectrum beta lactamases, AmpC and carbapenemase production among isolates of Escherichia coli in North Indian tertiary care centre

PubMed Central

Chaudhary, Uma; Agarwal, Shipra; Raghuraman, Kausalya

2018-01-01

Introduction: Identification of Extended spectrum beta lactamases (ESBL), AmpC production and carbapenemase production among isolates of Escherichia coli, helps clinician to rationalize the choice of antibiotics. However, there is a lack of simple and effective method for simultaneous identification of these beta lactamases. Aim: To determine the concurrent production of beta lactamases using twelve disc method on E. coli isolates. Materials and Methods: A total of 200 multidrug resistant E. coli were screened using twelve disc method. The isolates of ESBL were confirmed by ceftazidime/clavulanic acid and cefotaxime/clavulanic acid method. Metallo-beta-lactamases (MBL) were confirmed by imipenem EDTA combined disc method. Results: Among the 200 isolates, 42.5% were ESBL producers, 9% were MBL and 6.5% were Klebsiella pneumoniae carbapenemase (KPC) and AmpC each respectively. Coproduction was seen in 54 (27%). A significant difference in sensitivity was seen in cefuroxime, aztreonam, cefoxitin and ceftriaxone among inpatient and outpatients. Conclusion: The present study highlights burden of ESBL, AmpC, KPC and MBL along with their coproduction in a tertiary care hospital. In-house antibiotic policy, infection control and epidemiological surveys will help us in controlling these resistant bugs. We believe, the twelve disc method is a simple, inexpensive screening method for beta lactamase production. PMID:29682477

Animal source foods have a positive impact on the primary school test scores of Kenyan schoolchildren in a cluster-randomised, controlled feeding intervention trial.

PubMed

Hulett, Judie L; Weiss, Robert E; Bwibo, Nimrod O; Galal, Osman M; Drorbaugh, Natalie; Neumann, Charlotte G

2014-03-14

Micronutrient deficiencies and suboptimal energy intake are widespread in rural Kenya, with detrimental effects on child growth and development. Sporadic school feeding programmes rarely include animal source foods (ASF). In the present study, a cluster-randomised feeding trial was undertaken to determine the impact of snacks containing ASF on district-wide, end-term standardised school test scores and nutrient intake. A total of twelve primary schools were randomly assigned to one of three isoenergetic feeding groups (a local plant-based stew (githeri) with meat, githeri plus whole milk or githeri with added oil) or a control group receiving no intervention feeding. After the initial term that served as baseline, children were fed at school for five consecutive terms over two school years from 1999 to 2001. Longitudinal analysis was used controlling for average energy intake, school attendance, and baseline socio-economic status, age, sex and maternal literacy. Children in the Meat group showed significantly greater improvements in test scores than those in all the other groups, and the Milk group showed significantly greater improvements in test scores than the Plain Githeri (githeri+oil) and Control groups. Compared with the Control group, the Meat group showed significant improvements in test scores in Arithmetic, English, Kiembu, Kiswahili and Geography. The Milk group showed significant improvements compared with the Control group in test scores in English, Kiswahili, Geography and Science. Folate, Fe, available Fe, energy per body weight, vitamin B₁₂, Zn and riboflavin intake were significant contributors to the change in test scores. The greater improvements in test scores of children receiving ASF indicate improved academic performance, which can result in greater academic achievement.

Students' beliefs and behaviour regarding low-calorie beverages, sweets or snacks: are they affected by lessons on healthy food and by changes to school vending machines?

PubMed

Kocken, Paul L; van Kesteren, Nicole M C; Buijs, Goof; Snel, Jeltje; Dusseldorp, Elise

2015-06-01

To study the effects of school lessons about healthy food on adolescents' self-reported beliefs and behaviour regarding the purchase and consumption of soft drinks, water and extra foods, including sweets and snacks. The lessons were combined with the introduction of lower-calorie foods, food labelling and price reductions in school vending machines. A cluster-randomized controlled design was used to allocate schools to an experimental group (i.e. lessons and changes to school vending machines) and a control group (i.e. 'care as usual'). Questionnaires were used pre-test and post-test to assess students' self-reported purchase of extra products and their knowledge and beliefs regarding the consumption of low-calorie products. Secondary schools in the Netherlands. Twelve schools participated in the experimental group (303 students) and fourteen in the control group (311 students). The students' mean age was 13.6 years, 71.5% were of native Dutch origin and mean BMI was 18.9 kg/m(2). At post-test, the experimental group knew significantly more about healthy food than the control group. Fewer students in the experimental group (43%) than in the control group (56%) reported bringing soft drinks from home. There was no significant effect on attitude, social norm, perceived behavioural control and intention regarding the consumption of low-calorie extra products. The intervention had limited effects on students' knowledge and self-reported behaviour, and no effect on their beliefs regarding low-calorie beverages, sweets or snacks. We recommend a combined educational and environmental intervention of longer duration and engaging parents. More research into the effects of such interventions is needed.

Balance disorder and increased risk of falls in osteoporosis and kyphosis: significance of kyphotic posture and muscle strength.

PubMed

Sinaki, Mehrsheed; Brey, Robert H; Hughes, Christine A; Larson, Dirk R; Kaufman, Kenton R

2005-08-01

This controlled trial was designed to investigate the influence of osteoporosis-related kyphosis (O-K) on falls. Twelve community-dwelling women with O-K (Cobb angle, 50-65 degrees measured from spine radiographs) and 13 healthy women serving as controls were enrolled. Mean age of the O-K group was 76 years (+/-5.1), height 158 cm (+/-5), and weight 61 kg (+/-7.9), and mean age of the control group was 71 years (+/-4.6), height 161 cm (+/-3.8), and weight 66 kg (+/-11.7). Quantitative isometric strength data were collected. Gait was monitored during unobstructed level walking and during stepping over an obstacle of four different heights randomly assigned (2.5%, 5%, 10%, and 15% of the subject's height). Balance was objectively assessed with computerized dynamic posturography consisting of the sensory organization test. Back extensor strength, grip strength, and all lower extremity muscle groups were significantly weaker in the O-K group than the control group (P <0.05), except right ankle plantar flexors (P =0.09). There was a significant difference in the anteroposterior and mediolateral displacements and velocities. The O-K subjects had less anteroposterior displacement, greater mediolateral displacement, reduced anteroposterior velocity, and increased mediolateral velocity compared with controls for all conditions of unobstructed and obstructed level walking. Obstacle height had a significant effect on all center-of-mass variables. The O-K subjects had significantly greater balance abnormalities on computerized dynamic posturography than the control group (P =0.002). Data show that thoracic hyperkyphosis on a background of reduced muscle strength plays an important role in increasing body sway, gait unsteadiness, and risk of falls in osteoporosis.

The effect of plant sterols on serum triglyceride concentrations is dependent on baseline concentrations: a pooled analysis of 12 randomised controlled trials.

PubMed

Demonty, Isabelle; Ras, Rouyanne T; van der Knaap, Henk C M; Meijer, Linsie; Zock, Peter L; Geleijnse, Johanna M; Trautwein, Elke A

2013-02-01

Plant sterols (PS) are well known for their low-density lipoprotein cholesterol-lowering effect. Until recently, they were believed to have little or no impact on blood triglycerides (TG). However, studies taken individually were possibly lacking statistical power to detect modest TG decreases. This study was performed to quantify the TG-lowering effect of PS by pooling individual subject data from 12 randomised controlled trials that investigated the effects of PS on blood lipids. The main outcome variable was the control-adjusted PS effect on relative (%) and absolute (mmol/L) changes in TG. The relative and absolute changes in high-density lipoprotein cholesterol (HDL-C) were also assessed. Differences in changes of serum lipid concentrations between PS and control treatments were estimated by an ANCOVA using a random effect model which included PS intake (active or control), study and predefined subject characteristics. The twelve randomised controlled trials included in total 935 hypercholesterolaemic subjects not preselected based on their baseline TG concentrations. In most studies, the PS dose ranged between 1.6 and 2.5 g/day. PS intake significantly lowered serum TG by 6.0% (95% CI: -10.7, -1.2) or 0.12 mmol/L (95% CI: -0.20, -0.04). No significant interaction was observed between PS intake and baseline TG concentrations on relative changes, but, on absolute changes, interaction was significant with larger TG decreases observed with higher TG concentrations at baseline. No effects were observed on HDL-C concentrations. These results show that PS exert a modest TG-lowering effect which is dependent on baseline concentrations.

Preference and Expectation for Treatment Assignment in a Randomized Controlled Trial of Once- vs Twice-weekly Yoga for Chronic Low Back Pain

PubMed Central

Weinberg, Janice; Sherman, Karen J.; Saper, Robert B.

2015-01-01

Background: In studies involving nonpharmacological complementary and alternative medicine interventions, participant blinding is very difficult. Participant expectations may affect perceived benefit of therapy. In studies of yoga as treatment for chronic low back pain, little is known about the relationship between patient expectations and preferences on outcomes. This study was designed to identify baseline predictors of preference and to determine if expectations and preferences for different doses of yoga affect back-related function and low back pain intensity. Methods: This was a secondary data analysis of a 12-week randomized controlled trial comparing once-weekly vs twice-weekly yoga for treatment of chronic low back pain in 93 adults from a predominantly low-income minority population. At baseline, participants were asked about back function, back pain, treatment expectations, and treatment preferences. We created a variable “concordance” to describe the matching of participant preference to randomized treatment. Our outcome variables were change in back function and pain intensity after 12 weeks of yoga instruction. We performed logistic regression to identify predictors of preference for once- or twice-weekly yoga instruction. We created linear regression models to identify independent associations between expectations, preference, concordance, and outcomes. Results: Worse back function at baseline was associated with 20% higher odds of preferring twice-weekly yoga (OR 1.2, CI 1.1, 1.3). Individuals with higher expectation scores for twice-weekly yoga had 90% higher odds of preferring twice-weekly vs once-weekly yoga (OR 1.9, CI 1.3, 2.7). Individuals with higher expectation scores for once-weekly yoga had 40% less odds of preferring twice-weekly yoga (OR 0.6, CI 0.5, 0.9). After controlling for baseline characteristics, we found no statistically significant relationship between treatment outcomes, preference, expectation scores, or concordance. Conclusion: In a population of predominantly low-income minority participants with chronic low back pain, worse back function was associated with preference for more frequent yoga classes. Those who preferred more yoga classes had higher expectations for those classes. Twelve-week change in back pain intensity and back function were not affected by dosing preference, expectation score, or concordance. More research is needed to better measure and quantify preference, expectations, and their relationship to outcomes in yoga research. PMID:25694850

The effectiveness of Robot-Assisted Gait Training versus conventional therapy on mobility in severely disabled progressIve MultiplE sclerosis patients (RAGTIME): study protocol for a randomized controlled trial.

PubMed

Straudi, Sofia; Manfredini, Fabio; Lamberti, Nicola; Zamboni, Paolo; Bernardi, Francesco; Marchetti, Giovanna; Pinton, Paolo; Bonora, Massimo; Secchiero, Paola; Tisato, Veronica; Volpato, Stefano; Basaglia, Nino

2017-02-27

Gait and mobility impairments affect the quality of life (QoL) of patients with progressive multiple sclerosis (MS). Robot-assisted gait training (RAGT) is an effective rehabilitative treatment but evidence of its superiority compared to other options is lacking. Furthermore, the response to rehabilitation is multidimensional, person-specific and possibly involves functional reorganization processes. The aims of this study are: (1) to test the effectiveness on gait speed, mobility, balance, fatigue and QoL of RAGT compared to conventional therapy (CT) in progressive MS and (2) to explore changes of clinical and circulating biomarkers of neural plasticity. This will be a parallel-group, randomized controlled trial design with the assessor blinded to the group allocation of participants. Ninety-eight (49 per arm) progressive MS patients (EDSS scale 6-7) will be randomly assigned to receive twelve 2-h training sessions over a 4-week period (three sessions/week) of either: (1) RAGT intervention on a robotic-driven gait orthosis (Lokomat, Hocoma, Switzerland). The training parameters (torque of the knee and hip drives, treadmill speed, body weight support) are set during the first session and progressively adjusted during training progression or (2) individual conventional physiotherapy focusing on over-ground walking training performed with the habitual walking device. The same assessors will perform outcome measurements at four time points: baseline (before the first intervention session); intermediate (after six training sessions); end of treatment (after the completion of 12 sessions); and follow-up (after 3 months from the end of the training program). The primary outcome is gait speed, assessed by the Timed 25-Foot Walk Test. We will also assess walking endurance, balance, depression, fatigue and QoL as well as instrumental laboratory markers (muscle metabolism, cerebral venous hemodynamics, cortical activation) and circulating laboratory markers (rare circulating cell populations pro and anti-inflammatory cytokines/chemokines, growth factors, neurotrophic factors, coagulation factors, other plasma proteins suggested by transcriptomic analysis and metabolic parameters). The RAGT training is expected to improve mobility compared to the active control intervention in progressive MS. Unique to this study is the analysis of various potential markers of plasticity in relation with clinical outcomes. ClinicalTrials.gov, identifier: NCT02421731 . Registered on 19 January 2015 (retrospectively registered).

‘Help for Hay Fever’, a goal-focused intervention for people with intermittent allergic rhinitis, delivered in Scottish community pharmacies: study protocol for a pilot cluster randomized controlled trial

PubMed Central

2013-01-01

Background Despite the availability of evidence-based guidelines for managing allergic rhinitis in primary care, management of the condition in the United Kingdom (UK) remains sub-optimal. Its high prevalence and negative effects on quality of life, school performance, productivity and co-morbid respiratory conditions (in particular, asthma), and high health and societal costs, make this a priority for developing novel models of care. Recent Australian research demonstrated the potential of a community pharmacy-based ‘goal-focused’ intervention to help people with intermittent allergic rhinitis to self-manage their condition better, reduce symptom severity and improve quality of life. In this pilot study we will assess the transferability of the goal-focused intervention to a UK context, the suitability of the intervention materials, procedures and outcome measures and collect data to inform a future definitive UK randomized controlled trial (RCT). Methods/Design A pilot cluster RCT with associated preliminary economic analysis and embedded qualitative evaluation. The pilot trial will take place in two Scottish Health Board areas: Grampian and Greater Glasgow & Clyde. Twelve community pharmacies will be randomly assigned to intervention or usual care group. Each will recruit 12 customers seeking advice or treatment for intermittent allergic rhinitis. Pharmacy staff in intervention pharmacies will support recruited customers in developing strategies for setting and achieving goals that aim to avoid/minimize triggers for, and eliminate/minimize symptoms of allergic rhinitis. Customers recruited in non-intervention pharmacies will receive usual care. The co-primary outcome measures, selected to inform a sample size calculation for a future RCT, are: community pharmacy and customer recruitment and completion rates; and effect size of change in the validated mini-Rhinoconjunctivitis Quality of Life Questionnaire between baseline, one-week and six-weeks post-intervention. Secondary outcome measures relate to changes in symptom severity, productivity, medication adherence and self-efficacy. Quantitative data about accrual, retention and economic measures, and qualitative data about participants’ experiences during the trial will be collected to inform the future RCT. Discussion This work will lay the foundations for a definitive RCT of a community pharmacy-based ‘goal-focused’ self-management intervention for people with intermittent allergic rhinitis. Results of the pilot trial are expected to be available in April 2013. Trial registration Current Controlled Trials ISRCTN43606442 PMID:23856015

In vivo osseointegration of dental implants with an antimicrobial peptide coating.

PubMed

Chen, X; Zhou, X C; Liu, S; Wu, R F; Aparicio, C; Wu, J Y

2017-05-01

This study aimed to evaluate the in vivo osseointegration of implants with hydrophobic antimicrobial GL13K-peptide coating in rabbit femoral condyles by micro-CT and histological analysis. Six male Japanese Rabbits (4 months old and weighing 2.5 kg each) were included in this study. Twelve implants (3.75 mm wide, 7 mm long) were randomly distributed in two groups, with six implants in the experimental group coated with GL13K peptide and six implants in the control group without surface coating. Each implant in the test and the control group was randomly implanted in the left or right side of femoral condyles. On one side randomly-selected of the femur, each rabbit received a drill that was left without implant as control for the natural healing of bone. After 3 weeks of healing radiographic evaluation of the implant sites was taken. After 6 weeks of healing, rabbits were sacrificed for evaluation of the short-term osseointegration of the dental implants using digital radiography, micro-CT and histology analysis. To perform evaluation of osseointegration, implant location and group was double blinded for surgeon and histology/radiology researcher. Two rabbits died of wound infection in sites with non-coated implants 2 weeks after surgery. Thus, at least four rabbits per group survived after 6 weeks of healing. The wounds healed without suppuration and inflammation. No implant was loose after 6 weeks of healing. Radiography observations showed good osseointegration after 3 and 6 weeks postoperatively, which proved that the tissues followed a natural healing process. Micro-CT reconstruction and analysis showed that there was no statistically significant difference (P > 0.05) in volume of bone around the implant between implants coated with GL13K peptide and implants without coating. Histomorphometric analysis also showed that the mineralized bone area was no statistically different (P > 0.05) between implants coated with GL13K peptide and implants without coating. This study demonstrates that titanium dental implants with an antimicrobial GL13K coating enables in vivo implant osseointegration at similar bone growth rates than gold-standard non-coated dental implants up to 6 weeks of implantation in rabbit femurs.

Study protocol for improving asthma outcomes through cross-cultural communication training for physicians: a randomized trial of physician training.

PubMed

Patel, Minal R; Thomas, Lara J; Hafeez, Kausar; Shankin, Matthew; Wilkin, Margaret; Brown, Randall W

2014-06-16

Massive resources are expended every year on cross-cultural communication training for physicians. Such training is a focus of continuing medical education nationwide and is part of the curriculum of virtually every medical school in America. There is a pressing need for evidence regarding the effects on patients of cross-cultural communication training for physicians. There is a need to understand the added benefit of such training compared to more general communication. We know of no rigorous study that has assessed whether cross-cultural communication training for physicians results in better health outcomes for their patients. The current study aims to answer this question by enhancing the Physician Asthma Care Education (PACE) program to cross cultural communication (PACE Plus), and comparing the effect of the enhanced program to PACE on the health outcomes of African American and Latino/Hispanic children with asthma. A three-arm randomized control trial is used to compare PACE Plus, PACE, and usual care. Both PACE and PACE Plus are delivered in two, two-hour sessions over a period of two weeks to 5-10 primary care physicians who treat African American and Latino/Hispanic children with asthma. One hundred twelve physicians and 1060 of their pediatric patients were recruited who self-identify as African American or Latino/Hispanic and experience persistent asthma. Physicians were randomized into receiving either the PACE Plus or PACE intervention or into the control group. The comparative effectiveness of PACE and PACE Plus on clinician's therapeutic and communication practices with the family/patient, children's urgent care use for asthma, asthma control, and quality of life, and parent/caretaker satisfaction with physician performance will be assessed. Data are collected via telephone survey and medical record review at baseline, 9 months following the intervention, and 21 months following the intervention. This study aims to reduce disparities in asthma outcomes among African American and Latino/Hispanic children through cross-cultural communication training of their physicians and assessing the added value of this training compared to general communication. The results of this study will provide important information about the value of cross-cultural training in helping to address persistent racial disparities in outcomes. ClinicalTrials.gov: NCT01251523 December 1, 2010.

'Help for Hay Fever', a goal-focused intervention for people with intermittent allergic rhinitis, delivered in Scottish community pharmacies: study protocol for a pilot cluster randomized controlled trial.

PubMed

Porteous, Terry; Wyke, Sally; Smith, Sarah; Bond, Christine; Francis, Jill; Lee, Amanda J; Lowrie, Richard; Scotland, Graham; Sheikh, Aziz; Thomas, Mike; Smith, Lorraine

2013-07-15

Despite the availability of evidence-based guidelines for managing allergic rhinitis in primary care, management of the condition in the United Kingdom (UK) remains sub-optimal. Its high prevalence and negative effects on quality of life, school performance, productivity and co-morbid respiratory conditions (in particular, asthma), and high health and societal costs, make this a priority for developing novel models of care. Recent Australian research demonstrated the potential of a community pharmacy-based 'goal-focused' intervention to help people with intermittent allergic rhinitis to self-manage their condition better, reduce symptom severity and improve quality of life. In this pilot study we will assess the transferability of the goal-focused intervention to a UK context, the suitability of the intervention materials, procedures and outcome measures and collect data to inform a future definitive UK randomized controlled trial (RCT). A pilot cluster RCT with associated preliminary economic analysis and embedded qualitative evaluation. The pilot trial will take place in two Scottish Health Board areas: Grampian and Greater Glasgow & Clyde. Twelve community pharmacies will be randomly assigned to intervention or usual care group. Each will recruit 12 customers seeking advice or treatment for intermittent allergic rhinitis. Pharmacy staff in intervention pharmacies will support recruited customers in developing strategies for setting and achieving goals that aim to avoid/minimize triggers for, and eliminate/minimize symptoms of allergic rhinitis. Customers recruited in non-intervention pharmacies will receive usual care. The co-primary outcome measures, selected to inform a sample size calculation for a future RCT, are: community pharmacy and customer recruitment and completion rates; and effect size of change in the validated mini-Rhinoconjunctivitis Quality of Life Questionnaire between baseline, one-week and six-weeks post-intervention. Secondary outcome measures relate to changes in symptom severity, productivity, medication adherence and self-efficacy. Quantitative data about accrual, retention and economic measures, and qualitative data about participants' experiences during the trial will be collected to inform the future RCT. This work will lay the foundations for a definitive RCT of a community pharmacy-based 'goal-focused' self-management intervention for people with intermittent allergic rhinitis. Results of the pilot trial are expected to be available in April 2013. Current Controlled Trials ISRCTN43606442.