Preliminary Evidence that Self-Efficacy Predicts Physical Activity in Multiple Sclerosis

ERIC Educational Resources Information Center

Motl, Robert W.; McAuley, Edward; Doerksen, Shawna; Hu, Liang; Morris, Katherine S.

2009-01-01

Individuals with multiple sclerosis (MS) are less physically active than nondiseased people. One method for increasing physical activity levels involves the identification of factors that correlate with physical activity and that are modifiable by a well designed intervention. This study examined two types of self-efficacy as cross-sectional and…

Efficacy of a Brief Relaxation Training Intervention for Pediatric Recurrent Abdominal Pain

ERIC Educational Resources Information Center

Bell, Katrina M.; Meadows, Elizabeth A.

2013-01-01

This study is a preliminary investigation of the efficacy of a brief intervention for recurrent abdominal pain (RAP) via a multiple baseline across subjects design. The intervention consisted of a single 1-hour session including psychoeducation and coaching of breathing retraining; the length, duration, and content of the intervention were…

Development and Preliminary Evaluation of a One-Week Summer Treatment Program for Separation Anxiety Disorder

ERIC Educational Resources Information Center

Santucci, Lauren C.; Ehrenreich, Jill T.; Trosper, Sarah E.; Bennett, Shannon M.; Pincus, Donna B.

2009-01-01

Numerous clinical trials have demonstrated the efficacy of cognitive behavior therapy (CBT) for the treatment of childhood Separation Anxiety Disorder (SAD) and other anxiety disorders yet additional research may still be needed to better access and engage anxious youth. In this study, we investigated the acceptability and preliminary utility of a…

Preliminary Recommendations Regarding Preparation of Teachers and School Leaders to Use Learning Technologies

ERIC Educational Resources Information Center

Bull, Glen; Spector, J. Michael; Persichitte, Kay; Meier, Ellen

2017-01-01

This article describes preliminary work for the "Educational Technology Efficacy Research" symposium taking place in 2017. The symposium will present the role of efficacy research in the development, adoption, and implementation of educational technology. In preparation for this symposium, ten working groups are investigating the role of…

Work It Out Together: Preliminary Efficacy of a Parent and Adolescent DVD and Workbook Intervention on Adolescent Sexual and Substance Use Attitudes and Parenting Behaviors.

PubMed

Hadley, Wendy; Brown, L K; Barker, D; Warren, J; Weddington, P; Fortune, T; Juzang, I

2016-09-01

The purpose of the current study was to test an interactive DVD and workbook specifically designed for African-American parents and adolescents (ages 13-18), based on an efficacious face-to-face intervention, to address key factors associated with risk. A total of 170 parent-adolescent dyads were enrolled and randomly assigned to receive either the "Work It Out Together" DVD or a General Health Promotion DVD (HP). Parents and adolescents completed measures of HIV knowledge, self-efficacy, and parenting behaviors. Immediately after receiving the Work It Out Together intervention, parents and adolescents demonstrated higher HIV knowledge and greater HIV prevention self-efficacy. Three months after receiving the Work It Out Together intervention, parents and adolescents reported higher levels of parental monitoring and sexually active adolescents reported higher levels of condom use self-efficacy and a lower rate of recent sex. These outcomes provide preliminary evidence that the "Work It Out Together" DVD impacted individual attitudes and protective parenting behaviors.

Work It Out Together: Preliminary Efficacy of a Parent and Adolescent DVD and Workbook Intervention on Adolescent Sexual and Substance Use Attitudes and Parenting Behaviors

PubMed Central

Brown, L. K.; Barker, D.; Warren, J.; Weddington, P.; Fortune, T.; Juzang, I.

2016-01-01

The purpose of the current study was to test an interactive DVD and workbook specifically designed for African-American parents and adolescents (ages 13–18), based on an efficacious face-to-face intervention, to address key factors associated with risk. A total of 170 parent-adolescent dyads were enrolled and randomly assigned to receive either the “Work It Out Together” DVD or a General Health Promotion DVD (HP). Parents and adolescents completed measures of HIV knowledge, self-efficacy, and parenting behaviors. Immediately after receiving the Work It Out Together intervention, parents and adolescents demonstrated higher HIV knowledge and greater HIV prevention self-efficacy. Three months after receiving the Work It Out Together intervention, parents and adolescents reported higher levels of parental monitoring and sexually active adolescents reported higher levels of condom use self-efficacy and a lower rate of recent sex. These outcomes provide preliminary evidence that the “Work It Out Together” DVD impacted individual attitudes and protective parenting behaviors. PMID:27155880

Assessing Self-Efficacy Beliefs and Academic Outcomes: The Case for Specificity and Correspondence.

ERIC Educational Resources Information Center

Pajares, Frank

Guidelines regarding self-efficacy assessment are highlighted in the first section of this paper. In the second section, the issue of specificity versus generality of measurement is clarified. And last, preliminary results of a study of eighth graders (n=172) are presented which demonstrate that: (1) the optimal level of specificity of any…

Exploring breast-feeding self-efficacy.

PubMed

Kingston, Dawn; Dennis, Cindy-Lee; Sword, Wendy

2007-01-01

The purpose of this descriptive study was to explore the influence of efficacy-enhancing experiences on breast-feeding self-efficacy. Using the Breastfeeding Self-Efficacy Scale-Short Form, the influences of enactive mastery and various forms of experiences (vicarious, verbal persuasory, and physiological) on breast-feeding self-efficacy were assessed at 48 hours and 4 weeks postpartum among a convenience sample of 63 mothers. Those women who observed breast-feeding role models through videotapes or received praise from their partners or their own mothers had significantly higher levels of breast-feeding self-efficacy than mothers who did not. In addition, mothers who experienced physical pain or received professional assistance with breast-feeding difficulties had significantly lower levels of breast-feeding self-efficacy than those who did not. This study provides preliminary evidence that specific efficacy-enhancing strategies may significantly influence breast-feeding self-efficacy. Further research is warranted.

[Preliminary results of an open-label observational study evaluating the efficacy and safety of Prolia used in women with postmenopausal osteoporosis].

PubMed

Ershova, O B; Lesniak, O M; Belova, K Iu; Nazarova, A V; Manovitskaia, A V; Musaeva, T M; Musraev, R M; Nurlygaianov, R Z; Rozhinskaia, L Ia; Skripnikova, I A; Toroptsova, N V

2014-01-01

To evaluate the efficacy and safety of Denosumab (Prolia), a first-line osteoporosis (OP) medication that is a fully human monoclonal antibody to the receptor activator of nuclear factor xB ligand (RANKL), within an open-label observational study. Patients aged 50 years or older with postmenopausal OP, who were treated with Prolia in clinical practice, were examined. The concentrations of the bone resorption (BR) marker of C-terminal telopeptide and other laboratory indicators (total serum calcium, total alkaline phosphatase, and creatinine) were measured following 3 months. Adverse drug reactions were recorded. Three months after initiation of the investigation, there was a significant decrease in the BR marker C-terminal telopeptide (by 89%; p<0.0001). There were rare adverse reactions: hypocalcemia in 3 (5.9%) patients, arthralgias in 2 (3.9%), and eczema in 1 (1.9%). There were neither serious adverse events nor study withdrawal cases. The preliminary results of the open-label study of Prolia in postmenopausal OP suggest that the significantly lower BR activity determines the efficacy of this drug and its high safety.

Android Robot-Mediated Mock Job Interview Sessions for Young Adults with Autism Spectrum Disorder: A Pilot Study

PubMed Central

Kumazaki, Hirokazu; Warren, Zachary; Corbett, Blythe A.; Yoshikawa, Yuichiro; Matsumoto, Yoshio; Higashida, Haruhiro; Yuhi, Teruko; Ikeda, Takashi; Ishiguro, Hiroshi; Kikuchi, Mitsuru

2017-01-01

The feasibility and preliminary efficacy of an android robot-mediated mock job interview training in terms of both bolstering self-confidence and reducing biological levels of stress in comparison to a psycho-educational approach human interview was assessed in a randomized study. Young adults (ages 18–25 years) with autism spectrum disorder (ASD) were randomized to participate either in a mock job interview training with our android robot system (n = 7) or a self-paced review of materials about job-interviewing skills (n = 8). Baseline and outcome measurements of self-reported performance/efficacy and salivary cortisol were obtained after a mock job interview with a human interviewer. After training sessions, individuals with ASD participating in the android robot-mediated sessions reported marginally improved self-confidence and demonstrated significantly lower levels of salivary cortisol as compared to the control condition. These results provide preliminary support for the feasibility and efficacy of android robot-mediated learning. PMID:28955254

Android Robot-Mediated Mock Job Interview Sessions for Young Adults with Autism Spectrum Disorder: A Pilot Study.

PubMed

Kumazaki, Hirokazu; Warren, Zachary; Corbett, Blythe A; Yoshikawa, Yuichiro; Matsumoto, Yoshio; Higashida, Haruhiro; Yuhi, Teruko; Ikeda, Takashi; Ishiguro, Hiroshi; Kikuchi, Mitsuru

2017-01-01

The feasibility and preliminary efficacy of an android robot-mediated mock job interview training in terms of both bolstering self-confidence and reducing biological levels of stress in comparison to a psycho-educational approach human interview was assessed in a randomized study. Young adults (ages 18-25 years) with autism spectrum disorder (ASD) were randomized to participate either in a mock job interview training with our android robot system ( n  = 7) or a self-paced review of materials about job-interviewing skills ( n  = 8). Baseline and outcome measurements of self-reported performance/efficacy and salivary cortisol were obtained after a mock job interview with a human interviewer. After training sessions, individuals with ASD participating in the android robot-mediated sessions reported marginally improved self-confidence and demonstrated significantly lower levels of salivary cortisol as compared to the control condition. These results provide preliminary support for the feasibility and efficacy of android robot-mediated learning.

A Controlled Pilot Trial of PainTracker Self-Manager, a Web-Based Platform Combined With Patient Coaching, to Support Patients' Self-Management of Chronic Pain.

PubMed

Sullivan, Mark; Langford, Dale J; Davies, Pamela Stitzlein; Tran, Christine; Vilardaga, Roger; Cheung, Gifford; Yoo, Daisy; McReynolds, Justin; Lober, William B; Tauben, David; Vowles, Kevin E

2018-03-29

The objective of this study was to develop and pilot test a chronic pain empowerment and self-management platform, derived from acceptance and commitment therapy, in a pain specialty setting. A controlled, sequential, nonrandomized study design was used to accommodate intervention development and to test the efficacy of the PainTracker Self-Manager (PTSM) intervention (Web-based educational modules and outcome tracking combined with tailored patient coaching sessions and provider guidance). Generalized estimating equations evaluated changes over time (baseline, 3 months, 6 months) in pain self-efficacy (primary outcome), chronic pain acceptance (activity engagement and pain willingness), perceived efficacy in patient-provider interactions, pain intensity and interference, and overall satisfaction with pain treatment (secondary outcomes) between intervention (n = 48) and usual care control groups (n = 51). The full study sample (N = 99) showed greater improvements over time (significant Group × Time interactions) in pain self-efficacy and satisfaction with pain treatment. Among study completers (n = 82), greater improvement in activity engagement as well as pain intensity and interference were also observed. These preliminary findings support the efficacy of the PTSM intervention in a pain specialty setting. Further research is needed to refine and expand the PTSM intervention and to test it in a randomized trial in primary care settings. We developed a Web-based patient empowerment platform that combined acceptance and commitment therapy-based educational modules and tailored coaching sessions with longitudinal tracking of treatments and patient-reported outcomes, named PTSM. Pilot controlled trial results provide preliminary support for its efficacy in improving pain self-efficacy, activity engagement, pain intensity and interference, and satisfaction with pain treatment. Copyright © 2018 The American Pain Society. Published by Elsevier Inc. All rights reserved.

Just-in-time automated counseling for physical activity promotion.

PubMed

Bickmore, Timothy; Gruber, Amanda; Intille, Stephen

2008-11-06

Preliminary results from a field study into the efficacy of automated health behavior counseling delivered at the moment of user decision-making compared to the same counseling delivered at the end of the day are reported. The study uses an animated PDA-based advisor with an integrated accelerometer that can engage users in dialogues about their physical activity throughout the day. Preliminary results indicate health counseling is more effective when delivered just-in-time than when delivered retrospectively.

Pilot testing an internet-based STI and HIV prevention intervention with Chilean women.

PubMed

Villegas, Natalia; Santisteban, Daniel; Cianelli, Rosina; Ferrer, Lilian; Ambrosia, Todd; Peragallo, Nilda; Lara, Loreto

2015-03-01

The incidence of sexually transmitted infections (STIs) and human immunodeficiency virus (HIV) is high among young Chilean women, and there are no STI or HIV prevention interventions available to them that incorporate technology. The purpose of this study was to investigate the preliminary efficacy of an Internet-based STI and HIV prevention intervention (I-STIPI) for Chilean young women on measures of STI- and HIV-related information, motivation, behavioral skills, and preventive behaviors. This is a pretest-posttest study. Forty young Chilean women between 18 and 24 years of age participated in an investigation of the I-STIPI's preliminary efficacy on STI and HIV prevention-related outcomes between baseline and a postintervention assessment. The intervention consisted of four online modules. Data collection was conducted in Santiago, Chile. Paired-samples t test analysis was used to determine whether there were significant differences in each of the outcome variables. After receiving I-STIPI, women reported a significant increase in levels of STI- and HIV-related knowledge, attitudes toward the use of condoms and perceived self-efficacy, and a reduction of risky sexual behaviors with uncommitted partners. The I-STIPI showed promise as an Internet-based intervention that can reduce barriers to accessing preventive interventions and increase STI and HIV preventive behaviors in young Chilean women. The study provided important information about the ability of an Internet-based intervention to reduce young women's risk factors and to provide positive preliminary efficacy on STI- and HIV-related outcomes. Internet-based interventions can eliminate many barriers to receiving prevention interventions and may prove to be cost effective. © 2014 Sigma Theta Tau International.

Pilot Testing an Internet-Based STI and HIV Prevention Intervention With Chilean Women

PubMed Central

Villegas, Natalia; Santisteban, Daniel; Cianelli, Rosina; Ferrer, Lilian; Ambrosia, Todd; Peragallo, Nilda; Lara, Loreto

2015-01-01

Purpose The incidence of sexually transmitted infections (STIs) and human immunodeficiency virus (HIV) is high among young Chilean women, and there are no STI or HIV prevention interventions available to them that incorporate technology. The purpose of this study was to investigate the preliminary efficacy of an Internet-based STI and HIV prevention intervention (I-STIPI) for Chilean young women on measures of STI- and HIV-related information, motivation, behavioral skills, and preventive behaviors. Design This is a pretest-posttest study. Forty young Chilean women between 18 and 24 years of age participated in an investigation of the I-STIPI’s preliminary efficacy on STI and HIV prevention-related outcomes between baseline and a postintervention assessment. The intervention consisted of four online modules. Data collection was conducted in Santiago, Chile. Paired-samples t test analysis was used to determine whether there were significant differences in each of the outcome variables. Findings After receiving I-STIPI, women reported a significant increase in levels of STI- and HIV-related knowledge, attitudes toward the use of condoms and perceived self-efficacy, and a reduction of risky sexual behaviors with uncommitted partners. Conclusions The I-STIPI showed promise as an Internet-based intervention that can reduce barriers to accessing preventive interventions and increase STI and HIV preventive behaviors in young Chilean women. Clinical Relevance The study provided important information about the ability of an Internet-based intervention to reduce young women’s risk factors and to provide positive preliminary efficacy on STI- and HIV-related outcomes. Internet-based interventions can eliminate many barriers to receiving prevention interventions and may prove to be cost effective. PMID:25410132

Evidence for S-adenosyl-L-methionine (SAM-e) for the treatment of major depressive disorder.

PubMed

Papakostas, George I

2009-01-01

Despite the increasingly large array of antidepressants available to treat major depressive disorder, patients continue to experience relatively modest response and remission rates. In addition, patients may experience adverse side effects from pharmacotherapy that not only hinder treatment compliance and adherence but, in some cases, may also contribute to increased disability, patient suffering, morbidity, and mortality. In order to enhance treatment efficacy and tolerability, patients and clinicians have become increasingly interested in nonpharmaceutical supplements for treating depression. One of the best-studied of these supplements is S-adenosyl-L-methionine (SAM-e), a naturally occurring molecule present in all living cells and a major methyl group donor in the human body. Controlled trials have found SAM-e to be more efficacious than placebo and equal in efficacy to the tricyclic antidepressants for treating major depressive disorder (MDD) when administered parenterally (either intravenously or intramuscularly). Less evidence supports the use of oral SAM-e, although some trials have demonstrated its efficacy as well. In addition, there is a paucity of evidence examining whether oral forms of SAM-e can be safe, well tolerated, and efficacious when used as adjunctive treatment for antidepressant nonresponders with MDD. Although preliminary data suggest SAM-e may be useful as an adjunctive therapy to antidepressants, controlled studies are needed to confirm or refute these preliminary findings. (c) Copyright 2009 Physicians Postgraduate Press, Inc.

Chronic disease self-management program for Chinese patients: a preliminary multi-baseline study.

PubMed

Chan, Sam C C; Siu, Andrew M H; Poon, Peter K K; Chan, Chetwyn C H

2005-12-01

This study reports the preliminary findings on the effects of the Chronic Disease Self-management Program on a group of Chinese participants who suffered from chronic diseases. A total of 23 participants were recruited in a multi-baseline study protocol. Their self-management behaviors, self-efficacy and health status were captured over three baseline assessments and one post-test assessment. The results indicated significant increases in the performance of stretching exercises, the management of cognitive symptoms and communication with physicians. Their self-efficacy in terms of these aspects was found to be significantly increased. However, changes in other aspects of self-management which required more special skills and coordination with outside agencies were not significant. The changes in the physical and mental statuses of the participants were also not significant. It was observed that the positive effects of the program could be attributed to traditional Chinese beliefs of 'self-discipline' and a welcoming response towards self-efficacy strategies. Further studies should adhere to standards of a randomized clinical trial and further examine the mechanisms underpinning the changes in self-management behaviors among Chinese people with chronic diseases.

Feasibility, Acceptability, and Preliminary Efficacy of an Online HIV Prevention Program for Diverse Young Men who have Sex with Men: The Keep It Up! Intervention

PubMed Central

Mustanski, Brian; Garofalo, Robert; Monahan, Colleen; Gratzer, Beau; Andrews, Rebecca

2013-01-01

Young men who have sex with men (YMSM) are disproportionately infected with HIV/AIDS and there are few prevention programs with published efficacy for this population. This study evaluated the feasibility, acceptability, and preliminary efficacy of an online, interactive, and highly engaging HIV prevention program called Keep It Up! The intervention was designed to be delivered to diverse YMSM upon receiving an HIV negative text result, with the goal for them to “Keep It Up” and stay negative. In a randomized clinical trial, the intervention was compared to an online didactic HIV knowledge condition. The study sample included 102 sexually active YMSM. Participants reported completing online modules in settings that were private and not distracting. Mixed methods data showed intervention participants felt the program was valuable and acceptable. Compared to the control condition, participants in the intervention arm had a 44 % lower rate of unprotected anal sex acts at the 12-week follow-up (p < 0.05). PMID:23673793

Testing of Intravenous Hemostatic Agents in a Novel Swine Model of Bleeding: Preliminary Results With FXa-PCPs

DTIC Science & Technology

2005-08-01

proceeds through a prothrombinase complex (prothrombin, factor Va, calcium, and phospholipid). Thrombin is the final product in the coagulation cascade...we report preliminary data on the efficacy of mixtures of highly purified blood coagulation factors (FVIIa and FXa) and phospholipids vesicles (PCPS...testing. Further study of these drugs for the use of traumatic hemorrhage is not warranted. 15. SUBJECT TERMS Recombinant Factor VI~a, factor Xa

Evidence-Based Mental Health Practices with Children Self-Efficacy Scale: Development and Preliminary Findings

ERIC Educational Resources Information Center

McMeel, Lorri S.; Leathers, Sonya J.; Strand, Tonya C.

2017-01-01

This article reviews existing measures related to evidence-based practices with children and self-efficacy and describes the development and psychometric properties of the Evidence-Based Mental Health Practices With Children Efficacy Scale. This scale was developed to assess students' and clinicians' self-efficacy in their abilities to use…

Feasibility and preliminary efficacy of high intensity interval training in type 2 diabetes.

PubMed

Terada, Tasuku; Friesen, Alanna; Chahal, Baljot S; Bell, Gordon J; McCargar, Linda J; Boulé, Normand G

2013-02-01

To compare the feasibility of high intensity interval exercise (HI-IE) versus moderate intensity continuous exercise (MI-CE) in patients with type 2 diabetes (T2D), and to investigate the preliminary efficacy of HI-IE and MI-CE for improving glycated hemoglobin A1c (HbA1c) and body composition. Individuals with T2D were recruited and randomly assigned to HI-IE and MI-CE. Exercise training was performed 5 days per week for 12 weeks. Recruitment, retention, adherence, feeling states and self-efficacy were analyzed for feasibility. Changes in HbA1c and percent body fat from baseline were investigated at 12 weeks to determine the preliminary efficacy. Of 126 participants showing interest to join the study, 15 individuals were randomized and completed the program. No participants dropped out from the study after enrollment. Adherence rates were high and did not differ between HI-IE and MI-CE (p>0.05; >97.2% of the eligible exercise sessions for both groups). Feeling states and self-efficacy did not differ between the groups. Percent trunk fat decreased in both HI-IE and MI-CE (p=0.007 and 0.085, respectively). Total percent body fat, percent leg fat, and subcutaneous fat width were significantly reduced in both groups (p<0.05), whereas HbA1c did not change from baseline (p>0.05). The degree of improvement was similar between the interventions (p>0.05). In individuals with T2D, implementing a 12-week structured HI-IE training can be as feasible as MI-CE training. Both interventions are equally effective in lowering total body fat but have little impact on HbA1c in relatively well controlled participants with T2D. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

[Herbal medicine in womens' life cycle].

PubMed

Ben-Arye, Eran; Oren, Amnon; Ben-Arie, Alon

2006-10-01

Women use herbs and other traditional and complementary modalities to treat various ailments throughout their life circle. This article reviewed 19 randomized controlled trials, which studied efficacy and safety of various herbs in the treatment of premenstrual syndrome (PMS), nausea and vomiting in the first trimester of pregnancy and menopausal hot flushes. Preliminary data support the efficacy of Chaste tree fruit (Vitex agnus) in the treatment of PMS, Ginger (Zingiber officinale) in the treatment of hyperemesis gravidarum and (Cimicifuga racemosa) in the treatment of menopausal hot flushes. Additional and more rigorous studies are warranted in order to support the efficacy and safety of these herbal remedies.

[Initial experiences with amisulpride, an in Germany novel, atypical neuroleptic drug in treatment of adolescents with psychiatric disorders].

PubMed

Göpel, C; Marcus, A

2001-08-01

In addition to conventional antipsychotic drugs, during the past decade an increasing number of atypical neuroleptics has been introduced in the treatment of juvenile schizophrenic and schizoaffective disorders. In 1999 Germany legalized the benzamide amisulpride for the treatment of acute and chronic schizophrenic symptoms. Preliminary treatment results are reported here. Ten adolescent cases are presented with regard to the efficacy, side effects and dosage of amisulpride. Preliminary results on the use of amisulpride are promising. The rate of side effects is tolerable. Amisulprise seems to constitute a useful alternative in the treatment of juvenile schizophrenia for those who suffer from intolerable side effects of classical or atypical neuroleptics. Controlled studies are warranted to further clarify its efficacy and safety in the treatment of adolescents.

Computer-assisted intraosseous anaesthesia for molar and incisor hypomineralisation teeth. A preliminary study.

PubMed

Cabasse, C; Marie-Cousin, A; Huet, A; Sixou, J L

2015-03-01

Anesthetizing MIH (Molar and Incisor Hypomineralisation) teeth is one of the major challenges in paediatric dentistry. Computer-assisted IO injection (CAIO) of 4% articaine with 1:200,000 epinephrine (Alphacaine, Septodont) has been shown to be an efficient way to anesthetize teeth in children. The aim of this study was to assess the efficacy of this method with MIH teeth. This preliminary study was performed using the Quick Sleeper system (Dental Hi Tec, Cholet, France) that allows computer-controlled rotation of the needle to penetrate the bone and computer-controlled injection of the anaesthetic solution. Patients (39) of the department of Paediatric Dentistry were included allowing 46 sessions (including 32 mandibular first permanent molars) to be assessed. CAIO showed efficacy in 93.5% (43/46) of cases. Failures (3) were due to impossibility to reach the spongy bone (1) and to achieve anaesthesia (2). This prospective study confirms that CAIO anaesthesia is a promising method to anesthetize teeth with MIH that could therefore be routinely used by trained practitioners.

Use of platelet rich plasma for the treatment of bicipital tendinopathy in spinal cord injury:: a pilot study.

PubMed

Ibrahim, Victor M; Groah, Suzanne L; Libin, Alexander; Ljungberg, Inger H

2012-01-01

The purpose of study is to explore the efficacy and safety of platelet rich plasma (PRP) in the nonoperative management of shoulder tendinopathy amongst individuals with spinal cord injury. This objective was met by completing a pilot study on the effectiveness and safety of a PRP injection into the biceps tendon demonstrating clinical and ultrasonagraphic pathology. Recent analysis of the preliminary pilot data has demonstrated remarkably convincing results demonstrating both the safety and efficacy of this novel intervention.

Multidisciplinary VA Cardiac Rehabilitation: Preliminary Results and Treatment Efficacy.

ERIC Educational Resources Information Center

Daly, Susan S.; And Others

Initial studies have suggested that a cardiac rehabilitation program (CRP) may improve the physical and psychological functioning of participants. However, these studies have generally addressed a relatively young group of employed adult males. Three studies were designed to target an older, generally retired Veterans Administration population for…

Autism: biomedical complementary treatment approaches.

PubMed

Hendren, Robert L

2013-07-01

This article provides a conceptual overview for the use of biomedical complementary and alternative medicine (CAM) treatments for autism spectrum disorders. Pharmaceutical agents with published studies are briefly mentioned; but the focus of the article is on possible biomedical CAM treatments, the rationale for their use, and the current database of mostly preliminary studies regarding their safety and efficacy. Of the more than 50 treatments currently listed here and in use by eager families, 9 are reviewed in more detail because of their promise from preliminary research studies or because of public interest. Copyright © 2013 Elsevier Inc. All rights reserved.

Feasibility and preliminary efficacy of a web-based smoking cessation intervention for HIV-infected smokers: a randomized controlled trial.

PubMed

Shuter, Jonathan; Morales, Daniela A; Considine-Dunn, Shannon E; An, Lawrence C; Stanton, Cassandra A

2014-09-01

To evaluate the feasibility and preliminary efficacy of a Web-based tobacco treatment for persons living with HIV (PLWH). Prospective, randomized controlled trial. HIV-care center in the Bronx, New York. Eligibility criteria included HIV infection, current tobacco usage, interest in quitting, and access to a computer with internet. One hundred thirty-eight subjects enrolled, and 134 completed the study. Positively Smoke Free on the Web (PSFW), an 8-session, 7-week targeted tobacco treatment program for PLWH, was compared with standard care (brief advice to quit and self-help brochure). All subjects were offered nicotine patches. The main feasibility outcomes were number of sessions logged into, number of Web pages visited, number of interactive clicks, and total time logged in. The main efficacy outcome was biochemically verified, 7-day point prevalence abstinence 3 months after intervention. PSFW subjects logged into a mean of 5.5 of 8 sessions and 26.2 of 41 pages. They executed a mean of 10 interactive clicks during a mean total of 59.8 minutes logged in. Most required reminder phone calls to complete the sessions. Educational level, anxiety score, and home access of the Web site were associated with Web site usage. Ten percent of the PSFW group vs. 4.3% of controls achieved the abstinence end point. Among those who completed all 8 sessions, 17.9% were abstinent, and among women completers, 30.8% were abstinent. Web-based treatment is a feasible strategy for PLWH smokers, and preliminary findings suggest therapeutic efficacy.

A preliminary study on the short-term efficacy of chairside computer-aided design/computer-assisted manufacturing- generated posterior lithium disilicate crowns.

PubMed

Reich, Sven; Fischer, Sören; Sobotta, Bernhard; Klapper, Horst-Uwe; Gozdowski, Stephan

2010-01-01

The purpose of this preliminary study was to evaluate the clinical performance of chairside-generated crowns over a preliminary time period of 24 months. Forty-one posterior crowns made of a machinable lithium disilicate ceramic for full-contour crowns were inserted in 34 patients using a chairside computer-aided design/computer-assisted manufacturing technique. The crowns were evaluated at baseline and after 6, 12, and 24 months according to modified United States Public Health Service criteria. After 2 years, all reexamined crowns (n = 39) were in situ; one abutment exhibited secondary caries and two abutments received root canal treatment. Within the limited observation period, the crowns revealed clinically satisfying results.

The Development of a Physical Education Teachers' Physical Activity Self-Efficacy Instrument.

ERIC Educational Resources Information Center

Martin, Jeffrey J.; Kulinna, Pamela Hodges

2003-01-01

Developed a valid, reliable physical education teachers' physical activity self-efficacy scale for teaching classes in which students were engaged in high levels of physical activity. Results offer preliminary support for the psychometric properties of this instrument, which can help understand physical education teachers' efficacy in overcoming…

Acceptance and commitment therapy in youth with neurofibromatosis type 1 (NF1) and chronic pain and their parents: A pilot study of feasibility and preliminary efficacy.

PubMed

Martin, Staci; Wolters, Pamela L; Toledo-Tamula, Mary Anne; Schmitt, Shawn Nelson; Baldwin, Andrea; Starosta, Amy; Gillespie, Andrea; Widemann, Brigitte

2016-06-01

Neurofibromatosis type 1 (NF1) is an autosomal dominant genetic disorder affecting about 1 in 3,500 individuals. Chronic pain is commonly reported among individuals with NF1 and plexiform neurofibroma tumors (PNs). Acceptance and Commitment Therapy (ACT), an empirically supported method for addressing chronic pain, helps individuals re-focus on valued relationships and activities. This pilot study investigated the feasibility and preliminary efficacy of a brief ACT workshop in the NF1 population. Eligible participants included adolescents and young adults (AYA; 12-21 years) with NF1 and chronic pain that interfered with daily functioning and their parents. Patients and parents completed baseline measures of pain interference, pain intensity, functional disability, pain acceptance, depression, and anxiety. Then, AYA and parents participated separately in a 2-day small-group ACT workshop. A telephone booster session occurred 1 month post-intervention. Three-month post-treatment measures were completed by mail. Ten adolescents (4 males; M age = 16.9 years) and seven parents provided baseline and 3-month data. Mean satisfaction with the study was moderate to high (3.9 for patients and 4.6 for parents on a 1-5 scales). Patients and parents reported significant declines in patients' pain interference at 3 months post-treatment. Patient-reported pain intensity significantly declined from baseline to 3 months. Parents reported marginally greater acceptance of their child's pain. No changes emerged in functional ability or mood. Preliminary findings suggest that a brief ACT group intervention is feasible and may help AYA with NF1 and PNs cope with their chronic pain, although larger randomized studies are needed to confirm treatment efficacy. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Distress mediates the association between personality predispositions and suicidality: a preliminary study in a Portuguese community sample.

PubMed

Campos, Rui C; Besser, Avi; Blatt, Sidney J

2012-01-01

The present study examined whether distress mediates the relationship between suicidality and the personality predispositions of Self-Criticism, Dependency/Neediness, and Efficacy. A community sample of Portuguese young adults (N = 105) completed, in a counterbalanced order, a sociodemographic questionnaire, the Depressive Experiences Questionnaire (DEQ), the Brief Symptom Inventory (BSI), and reports of any suicide attempts and/or ideation. Structural equation modeling indicated that Self-Criticism is significantly associated with suicidality, but Dependency and Efficacy are not. High levels of Self-Criticism and of Dependency and low levels of Efficacy are associated with distress. Distress mediates the association between Self-Criticism and suicidality; whereas Dependency and Efficacy are indirectly associated with suicidality through their associations with distress. Self-Critical and Dependent individuals are at greater risk for suicide because of their vulnerability to distressful events; whereas certain levels of Efficacy may decrease vulnerability to distress and suicide risk.

Efficacy and tolerability of quetiapine in the treatment of bipolar disorder: preliminary evidence from a 12-month open-label study.

PubMed

Altamura, A C; Salvadori, Daniele; Madaro, Donato; Santini, Annalisa; Mundo, Emanuela

2003-09-01

The literature on the use of quetiapine for the treatment of bipolar disorder (BD) is limited to case reports, and there are no systematic studies on the efficacy of quetiapine in the prophylactic treatment of BD. The aim of the present study was to compare the efficacy of flexible doses of quetiapine and well established mood stabilizers in the maintenance treatment of BD. Twenty-eight DSM-IV BD outpatients were consecutively recruited into the study and were randomized to receive one of two open-label treatments, with quetiapine or classical mood stabilizers at flexible doses for 12 months. Clinical assessment was carried out using BPRS, CGI, YMRS and the 21-item HAM-D at baseline (T0) and every 2 months until the end of the study. ANOVAs with repeated measures were applied to the rating scale scores considering the time and the treatment group as main factors. All patients experienced a significant improvement on the BPRS, CGI and HAM-D scores, with no significant side-effects and a good compliance. This study should be considered preliminary given the small sample size investigated and the open-label design. If these results will be replicated on larger samples and in controlled studies, there could be relevant implications for the use of quetiapine as an alternative maintenance treatment for BD.

Role of preliminary registry data in development of a clinical trial for an innovative device: a small but integral piece of a health policy initiative

PubMed Central

Ricci, Donald R.; de Vries, Joost; Blanc, Raphael

2017-01-01

ABSTRACT Establishing a national health policy at a macro level involves the integration of a series of health initiatives across a spectrum of activities, including clinical care. Evaluation of the safety and efficacy of a new medical device ultimately evolves to testing in humans. The pathway to a formal prospective clinical trial includes a stepwise appreciation of pre-clinical data and detailed analysis of data obtained from preliminary registries, where information about appropriate patient selection and use of the device is obtained. Evaluation of procedural and follow-up efficacy and safety data in a preliminary series of cases, chosen to simulate published data, allows the design and conduct of clinical trials that are required to verify preliminary observations, closing the loop on one aspect of modifying health policy decisions. PMID:28321285

Relative Efficacy of Self-Reward, Self-Punishment, and Self-Monitoring Techniques for Weight Loss

ERIC Educational Resources Information Center

Mahoney, Michael J.; And Others

1973-01-01

The findings of this study are interpreted as providing a preliminary indication that self-reward strategies are superior to self-punitive and self-recording strategies in the modification of at least some habit patterns. (Author)

Improving Classroom Learning Environments by Cultivating Awareness and Resilience in Education (CARE): Results of Two Pilot Studies

ERIC Educational Resources Information Center

Jennings, Patricia A.; Snowberg, Karin E.; Coccia, Michael A.; Greenberg, Mark T.

2011-01-01

Cultivating Awareness and Resilience in Education (CARE) is a professional development program designed to reduce stress and improve teachers' performance. Two pilot studies examined program feasibility and attractiveness and preliminary evidence of efficacy. Study 1 involved educators from a high-poverty urban setting (n = 31). Study 2 involved…

Source entitativity and the elaboration of persuasive messages: the roles of perceived efficacy and message discrepancy.

PubMed

Clark, Jason K; Wegener, Duane T

2009-07-01

Compared with nonentitative groups, entitative targets are considered to elicit more elaborative processing because of the singularity or unity they represent. However, when groups serve as sources of persuasive messages, other dynamics may operate. The current research suggests that entitativity is intrinsically linked to perceptions of a group's efficacy related to the advocacy, and this efficacy combines with the position of the appeal to determine message elaboration. When messages are counterattitudinal, entitative (efficacious) sources should elicit greater processing than nonentitative groups because of concern that the entitative sources may be more likely to bring about the negative outcomes proposed. However, when appeals are proattitudinal, sources low in entitativity (nonefficacious) should initiate more elaboration due to concern that they may be unlikely to facilitate the positive outcomes proposed. These hypotheses were supported in a series of studies. Preliminary studies established the entitativity-efficacy relation (Studies 1A and 1B). Primary persuasion studies showed that manipulations of source entitativity (Studies 2 and 3) and source efficacy (Studies 4A and 4B) have opposite effects on processing as a function of message discrepancy. (PsycINFO Database Record (c) 2009 APA, all rights reserved).

An integrated motivational interviewing and cognitive-behavioural intervention promoting physical activity maintenance for adults with chronic health conditions: A feasibility study.

PubMed

Scott, Sarah E; Breckon, Jeff D; Copeland, Robert J

2018-01-01

Objectives Physical activity is recommended for managing chronic health conditions but is rarely maintained. This feasibility study aimed to evaluate the preliminary efficacy of a motivational interviewing and cognitive-behavioural intervention for long-term physical activity for adults with chronic health conditions. Methods Participants ( N = 37) with stable conditions (e.g. diabetes) were randomized into a three-month motivational interviewing and cognitive-behavioural group ( N = 20) or usual care ( N = 17) after completing a physical activity referral scheme. Participants completed physical activity (e.g. average steps per day and kilocalorie expenditure), psychological (e.g. self-efficacy) and epidemiological (e.g. body mass index) standardized measures at baseline, three- and six-month follow-up. Treatment fidelity and feasibility were assessed. Results Thirty-five participants completed the study (96% retention). The motivational interviewing and cognitive-behavioural group maintained kilocalorie expenditure at three ( p = 0.009) and six months ( p = 0.009). Exercise barrier self-efficacy ( p = 0.03), physical ( p = 0.02) and psychological ( p = 0.01) physical activity experiences were increased at three months only. No difference was found for average steps/day, social support, coping skills and epidemiological factors. Discussion This is the first study to demonstrate the feasibility and preliminary efficacy of motivational interviewing and cognitive-behavioural interventions for promoting physical activity maintenance in a clinical population. A large-scale trial with a longer follow-up (≥6 months) is warranted with treatment fidelity assessment.

A Pilot Trial of Mindfulness Meditation Training for ADHD in Adulthood: Impact on Core Symptoms, Executive Functioning, and Emotion Dysregulation.

PubMed

Mitchell, John T; McIntyre, Elizabeth M; English, Joseph S; Dennis, Michelle F; Beckham, Jean C; Kollins, Scott H

2017-11-01

Mindfulness meditation training is garnering increasing empirical interest as an intervention for ADHD in adulthood, although no studies of mindfulness as a standalone treatment have included a sample composed entirely of adults with ADHD or a comparison group. The aim of this study was to assess the feasibility, acceptability, and preliminary efficacy of mindfulness meditation for ADHD, executive functioning (EF), and emotion dysregulation symptoms in an adult ADHD sample. Adults with ADHD were stratified by ADHD medication status and otherwise randomized into an 8-week group-based mindfulness treatment ( n = 11) or waitlist group ( n = 9). Treatment feasibility and acceptability were positive. In addition, self-reported ADHD and EF symptoms (assessed in the laboratory and ecological momentary assessment), clinician ratings of ADHD and EF symptoms, and self-reported emotion dysregulation improved for the treatment group relative to the waitlist group over time with large effect sizes. Improvement was not observed for EF tasks. Findings support preliminary treatment efficacy, though require larger trials.

Child Demographics Associated with Outcomes in a Community-Based Pivotal Response Training Program

ERIC Educational Resources Information Center

Baker-Ericzen, Mary J.; Stahmer, Aubyn C.; Burns, Amelia

2007-01-01

Although knowledge about the efficacy of treatments such as pivotal response training (PRT) for children with autism is increasing, studies of large-scale effectiveness for and transportability to diverse community populations are needed. The current study provides a large-scale preliminary assessment of (a) the effectiveness of a community-based…

A One Year Study of Mode Deactivation Therapy: Adolescent Residential Patients with Conduct and Personality Disorders

ERIC Educational Resources Information Center

Murphy, Christopher J.; Siv, Alexander M.

2011-01-01

This case study is to evaluate the effectiveness of Mode Deactivation Therapy (MDT) implementation in a child and adolescent residential treatment unit and provide preliminary effectiveness data on MDT versus treatment as usual (TAU). This case study compared the efficacy of two treatment methodologies for adolescent males in residential treatment…

mGluR antagonists and GABA agonists as novel pharmacological agents for the treatment of autism spectrum disorders.

PubMed

Oberman, Lindsay M

2012-12-01

The CDC currently estimates the prevalence of autism spectrum disorders (ASD) at 1 in 88 children. Though the exact etiology of ASD is unknown, recent studies implicate synaptic maturation and plasticity in the pathogenesis of ASD leading to an imbalance of excitation and inhibition, and specifically a disproportionately high level of excitation. Pharmacological agents that modulate excitation and inhibition are currently in clinical trials for treatment of ASD and show promising preliminary results. This paper reviews the literature implicating the role of glutamate and GABA pathways in the pathophysiology of ASD. It also provides a review of the current results from both animal models and human clinical trials of drugs aimed at normalizing the imbalance of excitation and inhibition through the use of metabotropic glutamate receptor (mGluR) antagonists and GABA agonists. Both mGluR antagonists and GABA agonists have promising preliminary data from animal model and small-scale Phase II human trials. They show significant efficacy in subpopulations and appear to have favorable side-effect profiles. Though preliminary data are extremely promising, results from ongoing larger, double-blind, placebo-controlled studies will give a more complete understanding of the efficacy and side-effect profile related to these drugs.

Effect of a Specialized Classroom Counseling Intervention on Increasing Self-Efficacy among First-Grade Rural Students

ERIC Educational Resources Information Center

Bardhoshi, Gerta; Duncan, Kelly; Erford, Bradley T.

2018-01-01

This preliminary research examined the effectiveness of a classroom counseling intervention on student self-efficacy development. Five first-grade classrooms in a rural school with high rates of economic disparity were randomly assigned to either a set of 12 specialized lessons emphasizing self-efficacy or lessons from the existing core…

Connecting Students to Mental Health Care: Pilot Findings from an Engagement Program for School Nurses

PubMed Central

Kim, Rachel E.; Becker, Kimberly D.; Stephan, Sharon H.; Hakimian, Serop; Apocada, Dee; Escudero, Pia V.; Chorpita, Bruce F.

2015-01-01

Schools function as the major provider of mental health services (MHS) for youth, but can struggle with engaging them in services. School nurses are well-positioned to facilitate referrals for MHS. This pilot study examined the feasibility, acceptability, and preliminary efficacy of an engagement protocol (EP) designed to enhance school nurses’ utilization of evidence-based engagement practices when referring youth to MHS. Participants were six school nurses and twenty-five adolescents in a large, urban school district. School nurses reported positive attitudes towards the EP, suggesting that they found it feasible and acceptable. Though there were small increases in school nurses’ use of engagement practices and in adolescents’ readiness for services following training, due to limited sample size, differences were not statistically significant. Still, pilot results suggest preliminary efficacy of training school nurses to strategically implement evidence-based engagement practices to increase adolescents’ engagement in MHS. PMID:26251671

Antidepressant response to aripiprazole augmentation associated with enhanced FDOPA utilization in striatum: a preliminary PET study

PubMed Central

Conway, Charles R.; Chibnall, John T.; Cumming, Paul; Mintun, Mark A.; Gebara, Marie Anne I.; Perantie, Dana C.; Price, Joseph L.; Cornell, Martha E.; McConathy, Jonathan E.; Gangwani, Sunil; Sheline, Yvette I.

2014-01-01

Several double blind, prospective trials have demonstrated an antidepressant augmentation efficacy of aripiprazole in depressed patients unresponsive to standard antidepressant therapy. Although aripiprazole is now widely used for this indication, and much is known about its receptor-binding properties, the mechanism of its antidepressant augmentation remains ill-defined. In vivo animal studies and in vitro human studies using cloned dopamine dopamine D2 receptors suggest aripiprazole is a partial dopamine agonist; in this preliminary neuroimaging trial, we hypothesized that aripiprazole’s antidepressant augmentation efficacy arises from dopamine partial agonist activity. To test this, we assessed the effects of aripiprazole augmentation on the cerebral utilization of 6-[18F]-fluoro-3,4-dihydroxy-L-phenylalanine (FDOPA) using positron emission tomography (PET). Fourteen depressed patients, who had failed 8 weeks of antidepressant therapy with selective serotonin reuptake inhibitors, underwent FDOPA PET scans before and after aripiprazole augmentation; eleven responded to augmentation. Whole brain, voxel-wise comparisons of pre- and post-aripiprazole scans revealed increased FDOPA trapping in the right medial caudate of augmentation responders. An exploratory analysis of depressive symptoms revealed that responders experienced large improvements only in putatively dopaminergic symptoms of lassitude and inability to feel. These preliminary findings suggest that augmentation of antidepressant response by aripiprazole may be associated with potentiation of dopaminergic activity. PMID:24468015

Evaluation of an attention and memory intervention post-childhood acquired brain injury: Preliminary efficacy, immediate and 6 months post-intervention.

PubMed

Catroppa, Cathy; Stone, Kate; Hearps, Stephen J C; Soo, Cheryl; Anderson, Vicki; Rosema, Stefanie

2015-01-01

Impairments in attention and memory are common sequelae following paediatric acquired brain injury (ABI). While it has been established that such impairments are long-term and, therefore, affect quality-of-life, there is a scarcity of evidence-based interventions to treat these difficulties. The current study aimed to pilot the efficacy of the Amsterdam Memory and Attention Training for Children (Amat-c: English version) using both neuropsychological and ecologically sensitive measures. It was expected that children with attention and memory difficulties post-ABI would show improved performance post-intervention on cognitive and ecological measures, with maintenance at 6 months post-intervention. Ten children with an ABI, between the ages of 8-13 years at the time of recruitment were identified through audits of presentations to a metropolitan paediatric hospital. Each child underwent screening, the 18 week intervention programme, pre-intervention, immediate and 6 month post-intervention assessments. Findings supported the hypothesis that children would show post-intervention (immediate and 6 month) improvement in areas of attention and memory, with generalization to everyday life. Preliminary results provide support for the efficacy of the Amat-c post-childhood ABI. A larger study is needed to confirm these findings, as a reduction in attention and memory difficulties will enhance everyday functioning.

Engaging Overweight Adolescents in a Health and Fitness Program Using Wearable Activity Trackers.

PubMed

Wilson, Marian; Ramsay, Samantha; Young, Kimberly J

Our objectives were to (a) examine feasibility and receptivity of overweight adolescents joining a community-based group fitness program and (b) test preliminary efficacy of a 12-week pilot intervention designed to promote health, fitness, and self-efficacy for the identified teens. The 12-week fitness program for overweight adolescents was developed and included planned physical activities, nutrition classes, and goal-setting sessions. A one-group pre-/posttest study design evaluated 20 participants from grades 10 through 12 who enrolled in the program pilot study. Participants were given a wearable activity tracker that captured data using an Internet-based platform. Outcome measures included body mass index, screen time, fitness, and cardiovascular measures. A community fitness program for overweight adolescents was successfully implemented. High school students were receptive to the intervention and reported high program satisfaction. Positive effects included measurements of strength, systolic blood pressure, weight, and screen time behaviors. This study provides evidence to support the feasibility, acceptance, and preliminary effects of the pilot program with overweight adolescents. Copyright © 2017 National Association of Pediatric Nurse Practitioners. Published by Elsevier Inc. All rights reserved.

Phytophthora ramorum and sudden oak death in California: IV. preliminary studies on chemical control

Treesearch

Matteo Garbelotto; David M. Rizzo; Lawrence Marais

2002-01-01

Chemical applications may provide one means of control for Phytophthora ramorum, the cause of Sudden Oak Death (SOD). Such controls have been effective with other Phytophthora species in landscape and orchard situations. We have initiated laboratory and field studies to test the efficacy of a number of products previously reported...

Preconditions for Post-Employment Learning: Preliminary Results from Ongoing Research

ERIC Educational Resources Information Center

Salter, Linda

2011-01-01

This article describes the first phase of a two-phase, mixed-method study. The study, now in progress, explores how and to what extent willingness to engage in learning in mature adulthood is influenced by prior experiences and specific individual personality variables, such as perceived locus of control and degree of self-efficacy. Study…

A Preliminary Examination of Covitality as Integrated Well-Being in College Students

ERIC Educational Resources Information Center

Jones, Camille N.; You, Sukkyung; Furlong, Michael J.

2013-01-01

The emergence of positive psychology has generated increased interest about the correlates of positive psychological functioning. Researchers have identified and studied various positive psychological constructs (e.g., hope, optimism, self-efficacy, gratitude, and life satisfaction) and found them to covary and to be positively associated with…

Depression in Adolescents with ASD: A Pilot RCT of a Group Intervention

ERIC Educational Resources Information Center

Santomauro, Damian; Sheffield, Jeanie; Sofronoff, Kate

2016-01-01

Depression is a potentially life threatening affective disorder that is highly prevalent in individuals with autism spectrum disorders (ASD). This study aimed to evaluate the feasibility, acceptability and preliminary efficacy of a cognitive behavioural intervention for depression in adolescents with ASD. Participants were randomly assigned to the…

Improving Research Participant Ethics: The Utility of an Online Educational Module

ERIC Educational Resources Information Center

Barber, Larissa K.; Bailey, Sarah F.; Bagsby, Patricia G.

2015-01-01

The undergraduate psychology curriculum often does not address guidelines for acceptable participant behavior. This two-part study tested the efficacy of a recently developed online learning module on ethical perceptions, knowledge, and behavior. In the preliminary quasi-experiment, students who viewed the module did not have higher…

Preliminary investigation of a videogame prototype for cigarette and marijuana prevention in adolescents.

PubMed

Duncan, Lindsay R; Hieftje, Kimberly D; Pendergrass, Tyra M; Sawyer, Benjamin G; Fiellin, Lynn E

2018-02-09

Videogames are becoming increasingly popular to deliver health interventions; however, their role in the primary prevention of cigarette and marijuana use has not yet been evaluated. The purpose of this study was to conduct a preliminary test of the efficacy of a role-playing videogame prototype, smokeSCREEN, aimed at developing knowledge and behavioral skills associated with primary prevention of cigarette and marijuana use. The authors also explored participants' gameplay experience. This study employed a 1-group pretest-posttest design with 25 adolescent boys and girls aged 11 to 14 years (M age = 11.56, SD = 0.77) who had never tried cigarettes or marijuana. Participants played four 1-hour gameplay sessions over a 2-week period. Assessments of knowledge, self-efficacy, attitudes, perceived norms, and intentions related to cigarette and marijuana prevention were collected at baseline and 2-week and 12-week follow-ups. Ratings of gameplay experience were collected after the 2 weeks of gameplay. One-way repeated-measures analyses of variance (ANOVAs) were conducted. Findings are (1) improvements in knowledge for both cigarette (Wilks' λ = 0.62, F(2, 23) = 7.21, P = .004) and marijuana (Wilks' λ = 0.67, F(2, 23) = 5.75, P = .009) use from pre- to post-gameplay that were characterized by large effects; and (2) nonsignificant trends in the expected direction emerged for changes in self-efficacy and perceived norms related to both cigarettes and marijuana that were characterized by medium-large effects. Overall, the players provided positive reports of their experience with the smokeSCREEN videogame prototype. These findings provide preliminary evidence that a videogame has the potential to influence key cognitive and motivational variables and can be an engaging means to deliver a cigarette and marijuana prevention intervention.

Determining the feasibility and preliminary efficacy of a stroke instructional and educational DVD in a multinational context: a randomized controlled pilot study.

PubMed

Jones, Kelly M; Bhattacharjee, Rohit; Krishnamurthi, Rita; Blanton, Sarah; Barker-Collo, Suzanne; Theadom, Alice; Thrift, Amanda G; Wolf, Steven L; Venketasubramanian, Narayanaswamy; Parmar, Priya; Maujean, Annick; Ranta, Annemarei; Cadilhac, Dominique; Sanya, Emmanuel O; MacKay-Lyons, Marilyn; Pandian, Jeyaraj D; Arora, Deepti; Obiako, Reginald O; Saposnik, Gustavo; Balalla, Shivanthi; Bornstein, Natan M; Langhorne, Peter; Norrving, Bo; Brown, Nita; Brainin, Michael; Taylor, Denise; Feigin, Valery L

2018-05-01

To assess the feasibility of conducting a randomized controlled trial of an instructional and educational stroke DVD and determine the feasibility and preliminary efficacy of this intervention in a multinational context. Non-funded, pilot randomized controlled trial of intervention versus usual care. International, multicentre, community-based. Community-living adults up to three years post stroke with moderate to severe disability and their nominated informal caregivers. Intervention patients viewed and practised rehabilitation techniques demonstrated in the DVD over six weeks. Trial feasibility by number of active recruitment sites, recruitment efficiency, randomization and follow-up. Intervention feasibility by patient and caregiver impressions. Preliminary efficacy by the quality of life - 5-level EuroQol-5D (EQ-5D) health status measure, General Health Questionnaire and Centre for Epidemiological Studies-Depression at two months. In total, 14 recruitment sites were established across eight countries. Recruitment was achieved at nine (64%) sites. Over 16 months, 66 participants were recruited (mean (SD) age = 63.5 (12.47) years) and randomized to intervention ( n = 34) and control ( n = 32) groups. In total, 54 (82%) completed a follow-up assessment. Patient and/or caregiver comments about the benefits and barriers to accessing the intervention were mixed. There were no significant between-group differences in outcomes at two months ( P > 0.05). Conducting a multinational trial of a stroke DVD requires full funding. The intervention was acceptable to some patients and their caregivers, yet a generalized education approach did not fully meet their needs and/or expectations. A more individualized method may be required to meet peoples' changing needs during stroke recovery.

Feasibility, safety, acceptability, and preliminary efficacy of measurement-based care depression treatment for HIV patients in Bamenda, Cameroon.

PubMed

Pence, Brian W; Gaynes, Bradley N; Atashili, Julius; O'Donnell, Julie K; Kats, Dmitry; Whetten, Kathryn; Njamnshi, Alfred K; Mbu, Tabenyang; Kefie, Charles; Asanji, Shantal; Ndumbe, Peter

2014-06-01

Depression affects 18-30 % of HIV-infected patients in Africa and is associated with greater stigma, lower antiretroviral adherence, and faster disease progression. However, the region's health system capacity to effectively identify and treat depression is limited. Task-shifting models may help address this large mental health treatment gap. Measurement-Based Care (MBC) is a task-shifting model in which a Depression Care Manager guides a non-psychiatric (e.g., HIV) provider in prescribing and managing antidepressant treatment. We adapted MBC for depressed HIV-infected patients in Cameroon and completed a pilot study to assess feasibility, safety, acceptability, and preliminary efficacy. We enrolled 55 participants; all started amitriptyline 25-50 mg daily at baseline. By 12 weeks, most remained at 50 mg daily (range 25-125 mg). Median (interquartile range) PHQ-9 depressive severity scores declined from 13 (12-16) (baseline) to 2 (0-3) (week 12); 87 % achieved depression remission (PHQ-9 <5) by 12 weeks. Intervention fidelity was high: HIV providers followed MBC recommendations at 96 % of encounters. Most divergences reflected a failure to increase dose when indicated. No serious and few bothersome side effects were reported. Most suicidality (prevalence 62 % at baseline; 8 % at 12 weeks) was either passive or low-risk. Participant satisfaction was high (100 %), and most participants (89 %) indicated willingness to pay for medications if MBC were implemented in routine care. The adapted MBC intervention demonstrated high feasibility, safety, acceptability, and preliminary efficacy in this uncontrolled pilot study. Further research should assess whether MBC could improve adherence and HIV outcomes in this setting.

A Pre-Post Evaluation of OpenMinds: a Sustainable, Peer-Led Mental Health Literacy Programme in Universities and Secondary Schools.

PubMed

Patalay, Praveetha; Annis, Jennifer; Sharpe, Helen; Newman, Robbie; Main, Dominic; Ragunathan, Thivvia; Parkes, Mary; Clarke, Kelly

2017-11-01

Engaging young people in the design and delivery of mental health education could lead to more effective interventions; however, few of these interventions have been evaluated. This study aimed to gain preliminary evidence with regards to the efficacy and acceptability of OpenMinds: a peer-designed and facilitated mental health literacy programme for university and secondary school students. The programme involves a structured programme of education and training for university medical students, who then deliver workshops in secondary schools. Pre- and post-surveys were completed by 234 school students who received two workshops and 40 university medical students who completed the OpenMinds programme and delivered the workshops. The main outcomes in both groups were components of mental health literacy (non-stigmatising attitudes, knowledge, social distance and helping attitudes). Perceived teaching efficacy and interest in mental health careers (university medical students) and workshop acceptability (school students) were also examined. University and school student participation in OpenMinds was associated with significant improvements in three of four mental health literacy elements in both samples. Knowledge and attitudes improved in both samples, social distance improved only in the university sample and knowledge of helping behaviours increased in the school sample. University students' perceived teaching efficacy improved but there was no change in their reported interest in pursuing psychiatry in their career. Acceptability was high; over 70% of the school students agreed that they enjoyed the workshops and liked being taught by a university student. This study provides preliminary evidence for the acceptability and efficacy of OpenMinds as a sustainable peer-led model of mental health education for young people. The OpenMinds programme is ready for efficacy testing in a randomised trial.

Will environmental interventions affect the level of mastery motivation among children with disabilities? A preliminary study.

PubMed

Waldman-Levi, Amiya; Erez, Asnat Bar-Haim

2015-03-01

Children with developmental disabilities tend to demonstrate lower levels of mastery motivation in comparison with typically developing children. The goal of this study was to investigate the effect of physical and social environmental interventions on the mastery motivation of children with disabilities. Participants included 19 children (from two classes) with disabilities between the ages of 2-4 years from an educational rehabilitation centre. The Individualized Assessment of Mastery Motivation was used to assess the level of mastery motivation; the Early Childhood Environment Rating Scale - Revised and the Teacher-Child Interaction Observation were used to assess the physical and social environments. A counterbalance study design was used such that the children from the two classes received two phases of intervention, social and physical environmental interventions. The study's results point to the advantage of the social intervention, over the physical one, in improving the child's mastery motivation. However, the results lend support for the efficacy of using both aspects of environmental changes to the overall persistent score. The study findings, although preliminary, demonstrate the efficacy of providing both social and physical environmental interventions to improve mastery motivation. Copyright © 2014 John Wiley & Sons, Ltd.

Preliminary evidence that self-efficacy predicts physical activity in multiple sclerosis.

PubMed

Motl, Robert W; McAuley, Edward; Doerksen, Shawna; Hu, Liang; Morris, Katherine S

2009-09-01

Individuals with multiple sclerosis (MS) are less physically active than non diseased people. One method for increasing physical activity levels involves the identification of factors that correlate with physical activity and that are modifiable by a well designed intervention. This study examined two types of self-efficacy as cross-sectional and prospective correlates of objectively measured physical activity in 16 individuals with a diagnosis of MS. The participants completed two measures of self-efficacy and then wore an accelerometer for a 5-day period at baseline and then at 3 months follow-up. Self-efficacy for continued physical activity was associated with baseline and follow-up levels of physical activity. Self-efficacy for overcoming barriers was associated with follow-up levels of physical activity and change in physical activity across a 3-month period. Researchers should consider self-efficacy as a possible component of an intervention that is designed to increase physical activity levels in those with MS. International Journal of Rehabilitation Research

Psilocybin-assisted treatment for alcohol dependence: a proof-of-concept study.

PubMed

Bogenschutz, Michael P; Forcehimes, Alyssa A; Pommy, Jessica A; Wilcox, Claire E; Barbosa, P C R; Strassman, Rick J

2015-03-01

Several lines of evidence suggest that classic (5HT2A agonist) hallucinogens have clinically relevant effects in alcohol and drug addiction. Although recent studies have investigated the effects of psilocybin in various populations, there have been no studies on the efficacy of psilocybin for alcohol dependence. We conducted a single-group proof-of-concept study to quantify acute effects of psilocybin in alcohol-dependent participants and to provide preliminary outcome and safety data. Ten volunteers with DSM-IV alcohol dependence received orally administered psilocybin in one or two supervised sessions in addition to Motivational Enhancement Therapy and therapy sessions devoted to preparation for and debriefing from the psilocybin sessions. Participants' responses to psilocybin were qualitatively similar to those described in other populations. Abstinence did not increase significantly in the first 4 weeks of treatment (when participants had not yet received psilocybin), but increased significantly following psilocybin administration (p < 0.05). Gains were largely maintained at follow-up to 36 weeks. The intensity of effects in the first psilocybin session (at week 4) strongly predicted change in drinking during weeks 5-8 (r = 0.76 to r = 0.89) and also predicted decreases in craving and increases in abstinence self-efficacy during week 5. There were no significant treatment-related adverse events. These preliminary findings provide a strong rationale for controlled trials with larger samples to investigate efficacy and mechanisms. NCT02061293. © The Author(s) 2015.

Self-Efficacy Buffers the Relationship between Educational Disadvantage and Executive Functioning.

PubMed

Zahodne, Laura B; Nowinski, Cindy J; Gershon, Richard C; Manly, Jennifer J

2015-04-01

Previous studies showed that control beliefs are more strongly related to global cognition and mortality among adults with low education, providing preliminary evidence that self-efficacy buffers against the negative impact of educational disadvantage on physical and cognitive health. The current study extends these findings to a nationally representative sample of men and women aged 30 to 85 and explores which cognitive domains are most strongly associated with self-efficacy, educational attainment, and their interaction. Data were obtained from 1032 adult (30-85) participants in the United States norming study for the NIH Toolbox. Self-efficacy, executive functioning, working memory, processing speed, episodic memory, and vocabulary were assessed with the NIH Toolbox. Multivariate analysis of covariance and follow-up regressions tested the hypothesis that self-efficacy would be more strongly related to cognitive performance among individuals with lower education, controlling for age, sex, race, ethnicity, education, reading level, testing language, and depressive symptoms. Higher education was associated with higher self-efficacy and better performance on all cognitive tests. Higher self-efficacy was associated with better set-switching and attention/inhibition. Significant self-efficacy by education interactions indicated that associations between self-efficacy and executive abilities were stronger for individuals with lower education. Specifically, individuals with low education but high self-efficacy performed similarly to individuals with high education. This study provides evidence that self-efficacy beliefs buffer against the negative effects of low educational attainment on executive functioning. These results have implications for future policy and/or intervention work aimed at reducing the deleterious effects of educational disadvantage on later cognitive health.

A Multi-Stage Longitudinal Comparative Design Stage II Evaluation of the Changing Lives Program: The Life Course Interview (RDA-LCI)

ERIC Educational Resources Information Center

Arango, Lisa Lewis; Kurtines, William M.; Montgomery, Marilyn J.; Ritchie, Rachel

2008-01-01

The study reported in this article, a Multi-Stage Longitudinal Comparative Design Stage II evaluation conducted as a planned preliminary efficacy evaluation (psychometric evaluation of measures, short-term controlled outcome studies, etc.) of the Changing Lives Program (CLP), provided evidence for the reliability and validity of the qualitative…

Development and Evaluation of a Short Anger Management Group for Special Education Teachers in Greece: A Preliminary Study

ERIC Educational Resources Information Center

Vassilopoulos, Stephanos P.; Brouzos, Andreas; Moberly, Nicholas J.; Tsiligiannis, Georgia

2015-01-01

This study investigated the efficacy of a psychoeducational group for Greek special education teachers, all but one of whom reported experiencing anger in class. An anger management program was designed, which included a short, four-session package to be given within two weeks. The results of a pretest-posttest comparison revealed reductions in…

Preliminary Evaluation of a Tier 2 Mathematics Intervention for First-Grade Students: Using a Theory of Change to Guide Formative Evaluation Activities

ERIC Educational Resources Information Center

Clarke, Ben; Doabler, Christian T.; Strand Cary, Mari; Kosty, Derek; Baker, Scott; Fien, Hank; Smolkowski, Keith

2014-01-01

This pilot study examined the efficacy of a Tier 2 first-grade mathematics intervention program targeting whole-number understanding for students at risk in mathematics. The study used a randomized block design. Students (N = 89) were randomly assigned to treatment (Fusion) or control (standard district practice) conditions. Measures of…

Motivational Enhancement Therapy for Adolescent Marijuana Users: A Preliminary Randomized Controlled Trial

ERIC Educational Resources Information Center

Walker, Denise D.; Roffman, Roger A.; Stephens, Robert S.; Wakana, Kim; Berghuis, James

2006-01-01

This study's aims were (a) to investigate the feasibility of a school-based motivational enhancement therapy (MET) intervention in voluntarily attracting adolescents who smoke marijuana regularly but who are not seeking formal treatment and (b) to evaluate the efficacy of the intervention in reducing marijuana use. Ninety-seven adolescents who had…

Learning Authentic Leadership in New Zealand: A Learner-Centred Methodology and Evaluation

ERIC Educational Resources Information Center

Roche, Maree

2010-01-01

This study provides preliminary examination of the efficacy of the "Best Authentic Leadership Self" exercise. A field quasi-experimental design was conducted with a dual purpose: (1) to ascertain the value of interventions aimed at triggering events to enhance the learning (c.f. teaching) of "authentic leadership? and how this…

Group Social Skills Instruction for Adolescents with High-Functioning Autism Spectrum Disorders

ERIC Educational Resources Information Center

White, Susan W.; Koenig, Kathleen; Scahill, Lawrence

2010-01-01

Given the increased recognition of autism spectrum disorders (ASD) and the chronic and pervasive nature of associated deficits, there is a pressing need for effective treatments. The feasibility and preliminary efficacy of a structured, group social skills training program for high-functioning youth with ASD was examined in this study. Fifteen…

Teaching Health Literacy Using Popular Television Programming: A Qualitative Pilot Study

ERIC Educational Resources Information Center

Primack, Brian A.; Wickett, Dustin J.; Kraemer, Kevin L.; Zickmund, Susan

2010-01-01

Background: Teaching of health and medical concepts in the K-12 curriculum may help improve health literacy. Purpose: The purpose of this project was to determine acceptability and preliminary efficacy of pilot implementation of a health literacy curriculum using brief clips from a popular television program. Methods: Participants included 55…

Efficacy Study of a Pre-Algebra Supplemental Program in Rural Mississippi: Preliminary Findings

ERIC Educational Resources Information Center

Clark, Tedra F.; Arens, Sheila A.; Stewart, Joshua

2015-01-01

Mastering mathematics is important for all students, not only because such success increases college and career options and prospects for future income, but also because mathematics literacy helps citizens and policy leaders to make sound judgments (NMAP, 2008). Research suggests that the rural achievement gap can be addressed with modifiable…

Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors

ClinicalTrials.gov

2016-02-18

Dose Escalation; Safety; Preliminary Efficacy; Advanced Solid Tumors; Metastatic Breast Cancer; Advanced Pancreatic Adenocarcinoma; Metastatic Colorectal Cancer; Recurrent Glioblastoma Multiforme; Gastric Cancer; Gastroesophageal Junction Cancer; Triple Negative Metastatic Breast Cancer; Hormone Receptor Positive (ER+/PR+, and Her2-) Metastatic Breast Cancer

The Efficacy of Crisis Intervention Training for Educators: A Preliminary Study from the United States

ERIC Educational Resources Information Center

Forthun, Larry F.; McCombie, Jeffrey W.

2011-01-01

Professional development in crisis intervention skills can help address the growing needs of schools to train faculty to respond to students in acute crisis. Unlike traditional methods of classroom management, crisis intervention training teaches specific strategies to de-escalate conflict while at the same time addressing the underlying…

The Efficacy of Adapted MBCT on Core Symptoms and Executive Functioning in Adults With ADHD: A Preliminary Randomized Controlled Trial.

PubMed

Hepark, Sevket; Janssen, Lotte; de Vries, Alicia; Schoenberg, Poppy L A; Donders, Rogier; Kan, Cornelis C; Speckens, Anne E M

2015-11-20

The aim of this study was to examine the effectiveness of mindfulness as a treatment for adults diagnosed with ADHD. A 12-week-adapted mindfulness-based cognitive therapy (MBCT) program is compared with a waiting list (WL) group. Adults with ADHD were randomly allocated to MBCT (n = 55) or waitlist (n = 48). Outcome measures included investigator-rated ADHD symptoms (primary), self-reported ADHD symptoms, executive functioning, depressive and anxiety symptoms, patient functioning, and mindfulness skills. MBCT resulted in a significant reduction of ADHD symptoms, both investigator-rated and self-reported, based on per-protocol and intention-to-treat analyses. Significant improvements in executive functioning and mindfulness skills were found. Additional analyses suggested that the efficacy of MBCT in reducing ADHD symptoms and improving executive functioning is partially mediated by an increase in the mindfulness skill "Act With Awareness." No improvements were observed for depressive and anxiety symptoms, and patient functioning. This study provides preliminary support for the effectiveness of MBCT for adults with ADHD. © The Author(s) 2015.

Efficacy of hijamat bila shurt (dry cupping) on intensity of pain in dysmenorrhoea-a preliminary study.

PubMed

Sultana, Arshiya; Ur Rahman, Khaleeq; Farzana, Muzn; Lone, Azad

2010-10-01

Waje rehm (Dysmenorrhoea) means painful menstruation. Since ancient times, hijamat bila shurt (Dry cupping) is a method of treatment of for this disease. Therefore, objective of this preliminary study was to evaluate the efficacy of hijamat bila shurt on intensity of pain in waje rehm by using Visual Analogue Scale for pain. It was conducted from May 2009 to July 2010 on 25 patients in National Institute of Unani Medicine, Bangalore. Patients suffering from primary and secondary dysmenorrhoea with regular cycles, age group 12-37years were selected. For dry cupping, two glass cup of medium size were applied below the umbilicus for 15 minutes on day land/or day 2 of the menstrual phase for one cycle and pain intensity was assessed by Visual Analogue Scale score for pain before and after the treatment. The Mean and Standard Error Mean for pain intensity before and after the treatment was 6.48 (0.32) and 2.12 (0.32) respectively with P<0.001, considered significant. Thus, hijamat bila shurt was effective in reducing pain intensity in dysmenorrhoea.

A survey of diet self-efficacy and food intake in students with high and low perceived stress.

PubMed

Nastaskin, Robyn S; Fiocco, Alexandra J

2015-04-23

Given the rise in obesity and obesity-related disorders, understanding the relationship between stress, self-efficacy and food choice in young adulthood may have implications for preventing negative health outcomes later in life that stem from poor eating habits. The current study examined whether stress levels and diet self-efficacy may be associated with unhealthy eating habits in young adults. Male and female undergraduate students (N = 136) completed questionnaires that tap into diet self-efficacy (DSE), perceived stress (PS), sodium, and fat intake. Sex differences in choice of food were predicted, and low levels of perceived stress and high diet self-efficacy were expected to be associated with lower fat and sodium intake. Findings indicate an interaction between perceived stress and diet self-efficacy on fat intake and a main effect for diet self-efficacy on sodium intake in this population. As expected, low levels of perceived stress and high diet self-efficacy were associated with the lowest levels of fat and sodium intake in students. Findings were driven by females. This study provides preliminary evidence that diet self-efficacy and perceived stress levels relate to nutrient intake in young adult females, and that increasing diet self-efficacy and reducing perceived stress in young adult females may lead to reductions in fat and sodium intake, leading to healthier eating habits.

Evaluating the Efficacy of Remediation for Struggling Readers in High School

ERIC Educational Resources Information Center

Lovett, Maureen W.; Lacerenza, Lea; De Palma, Maria; Frijters, Jan C.

2012-01-01

Preliminary efficacy data are reported for a research-based reading intervention designed for struggling readers in high school. PHAST PACES teaches (a) word identification strategies, (b) knowledge of text structures, and (c) reading comprehension strategies. In a quasi-experimental design, 268 intervention and 83 waiting list control students…

Development and Initial Evaluation of the Web-Based Self-Management Program "Partner in Balance" for Family Caregivers of People With Early Stage Dementia: An Exploratory Mixed-Methods Study.

PubMed

Boots, Lizzy Mm; de Vugt, Marjolein E; Withagen, Hanneke Ej; Kempen, Gertrudis Ijm; Verhey, Frans Rj

2016-03-01

People with dementia increasingly depend on informal caregivers. Internet-based self-management interventions hold considerable promise for meeting the educational and support needs of early stage dementia caregivers (EDCs) at a reduced cost. This study aimed to (1) develop an online self-management program for EDC to increase self-efficacy and goal attainment, and (2) evaluate the program's feasibility and report preliminary data on effectiveness. Based on the Medical Research Council (MRC) framework for the development and evaluation of complex interventions, a stepwise approach was adopted to explore potential user needs and develop and validate the content by means of (1) focus group discussions with dementia caregivers (N=28), (2) interviews with dementia care professionals (N=11), and (3) individual think-aloud usability tests with EDC (N=2) and experts (N=2). A pilot evaluation was conducted with EDC (N=17) to test the feasibility and establish preliminary effects. Self-report measures of feasibility were completed after the completion of intervention. Self-efficacy and goal attainment were evaluated before and after the intervention. The different steps provided useful information about the needs of potential users regarding the content and delivery of the program. This resulted in the newly developed "Partner in Balance" program. At the start, system failures resulted in a high noncompleter rate (7/17, 41%), but at the end, an acceptable feasibility score of 209 (range 54-234) was found. The convenience of completing the program at home, the tailored content, and the guidance (face-to-face and online) were appraised positively. Preliminary effects on caregiver self-efficacy (P<.05) and goal attainment (T>50) were promising. Adaptations were made to the program to limit the amount of system failures and prevent high noncompleter rates. As recommended by the MRC framework, confirming the feasibility and preliminary effectiveness is a valuable step toward examining the effectiveness of this newly developed intervention. Dutch Trial Register (NTR): NTR4217; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4217 (Archived by WebCite at http://www.webcitation.org/6f6B8lvRP).

Improvement in Stress, General Self-Efficacy, and Health Related Quality of Life following Patient Education for Patients with Neuroendocrine Tumors: A Pilot Study.

PubMed

Haugland, Trude; Veenstra, Marijke; Vatn, Morten H; Wahl, Astrid K

2013-01-01

The purpose of the study was to evaluate changes in general self-efficacy, health related quality of life (HRQoL), and stress among patients with neuroendocrine tumors (NET) following a multidisciplinary educational intervention. Forty-one patients were enrolled in this exploratory pilot study. A total of 37 patients completed the full 26-week intervention based on the principles of self-efficacy. General self-efficacy was measured by the General Self-Efficacy Scale, HRQoL was measured with the SF-36, and stress was measured with the Impact of Event Scale. Mixed effect models were used to evaluate changes in general self-efficacy, mental and physical components of HRQoL, and stress adjusting for demographic and clinical variables. Results showed significant improvements in patients' general self-efficacy (β = 0.71; P < 0.05), physical component scores of HRQoL (β = 3.09; P < 0.01), and stress (β = -2.10, P = 0.008). Findings suggest that patients with NET have the capacity to improve their ability to cope with their disease, problem-solve, improve their physical status, and reduce their stress following an educational intervention based on the principles of self-efficacy. These preliminary data provide a basis for future randomized controlled trials to test interventions to improve HRQoL for patients with NET.

Feasibility, Preliminary Efficacy, and Lessons Learned From a Garden-Based Lifestyle Intervention for Cancer Survivors.

PubMed

Spees, Colleen K; Hill, Emily B; Grainger, Elizabeth M; Buell, Jackie L; White, Susan E; Kleinhenz, Matthew D; Clinton, Steven K

2016-07-01

Cancer survivors remain at increased risk for secondary malignancies, comorbidities, and all-cause mortality. Lifestyle behaviors, such as diet and physical activity, are strongly linked to a decreased risk of chronic disease and improved health outcomes, yet a paucity of research has been conducted in this vulnerable population. Adult cancer survivors were recruited to participate in Growing Hope, an experimental single-group study designed to assess the feasibility and efficacy of a theory-driven and evidence-based intervention. For 4 months, 22 participants received group and individual education and had access to harvesting fresh produce at an urban garden. Data on program satisfaction, compliance, diet, and physical activity were collected via surveys; anthropometrics, blood values, and skin carotenoids were objectively measured. The intervention resulted in significant improvements in consumption of fruits and vegetables (P = .003), decreased consumption of red and processed meats (P = .030) and sugar-sweetened beverages (P = .020). Levels of skin carotenoids, fasting blood glucose, and non-high density lipoprotein cholesterol were also significantly improved (P = .011, P = .043, and P = .05, respectively). The results of this study support the feasibility and efficacy of a multifaceted, garden-based intervention for cancer survivors. In addition, these preliminary results demonstrate a positive impact aligning with the current lifestyle recommendations for cancer survivorship. Larger randomized controlled trials are warranted to define impact on sustained health outcomes.

Feasibility, Preliminary Efficacy, and Lessons Learned From a Garden-Based Lifestyle Intervention for Cancer Survivors

PubMed Central

Spees, Colleen K.; Hill, Emily B.; Grainger, Elizabeth M.; Buell, Jackie L.; White, Susan E.; Kleinhenz, Matthew D.; Clinton, Steven K.

2016-01-01

Background Cancer survivors remain at increased risk for secondary malignancies, comorbidities, and all-cause mortality. Lifestyle behaviors, such as diet and physical activity, are strongly linked to a decreased risk of chronic disease and improved health outcomes, yet a paucity of research has been conducted in this vulnerable population. Methods Adult cancer survivors were recruited to participate in Growing Hope, an experimental single-group study designed to assess the feasibility and efficacy of a theory-driven and evidence-based intervention. For 4 months, 22 participants received group and individual education and had access to harvesting fresh produce at an urban garden. Data on program satisfaction, compliance, diet, and physical activity were collected via surveys; anthropometrics, blood values, and skin carotenoids were objectively measured. Results The intervention resulted in significant improvements in consumption of fruits and vegetables (P = .003), decreased consumption of red and processed meats (P = .030) and sugar-sweetened beverages (P = .020). Levels of skin carotenoids, fasting blood glucose, and non–high density lipoprotein cholesterol were also significantly improved (P = .011, P = .043, and P = .05, respectively). Conclusions The results of this study support the feasibility and efficacy of a multifaceted, garden-based intervention for cancer survivors. In addition, these preliminary results demonstrate a positive impact aligning with the current lifestyle recommendations for cancer survivorship. Larger randomized controlled trials are warranted to define impact on sustained health outcomes. PMID:27556671

Integrating HIV Prevention and Relationship Education for Young Same-Sex Male Couples: A Pilot Trial of the 2GETHER Intervention.

PubMed

Newcomb, Michael E; Macapagal, Kathryn R; Feinstein, Brian A; Bettin, Emily; Swann, Gregory; Whitton, Sarah W

2017-08-01

Young men who have sex with men are at high risk for HIV, and most new HIV infections occur in serious relationships. This pilot study assessed the feasibility, acceptability and preliminary efficacy of the 2GETHER couples-based HIV prevention and relationship education intervention for young same-sex male couples. We enrolled 57 young male couples (N = 114) into a four-session hybrid group and individual intervention. We assessed acceptability via post-session surveys and exit interviews, and we examined preliminary efficacy at a two week posttest. The vast majority of participants (93%) reported exclusively positive impressions of 2GETHER, and all components received high mean ratings. We observed decreases in HIV risk behavior, increases in information, motivation and behavioral skills related to HIV prevention, and improvement in relationship investment between pretest and posttest. Integrating relationship education and sexual health programming may be an effective way to reduce HIV transmissions in young male couples.

Examining the Feasibility, Tolerability, and Preliminary Efficacy of Repetitive Task-Specific Practice for People With Unilateral Spatial Neglect

PubMed Central

Lang, Catherine E.; Birkenmeier, Rebecca; Holm, Margo; Rubinstein, Elaine; Van Swearingen, Jessie; Skidmore, Elizabeth R.

2016-01-01

OBJECTIVE. We examined the feasibility, tolerability, and preliminary efficacy of repetitive task-specific practice for people with unilateral spatial neglect (USN). METHOD. People with USN ≥6 mo poststroke participated in a single-group, repeated-measures study. Attendance, total repetitions, and satisfaction indicated feasibility and pain indicated tolerability. Paired t tests and effect sizes were used to estimate changes in upper-extremity use (Motor Activity Log), function (Action Research Arm Test), and attention (Catherine Bergego Scale). RESULTS. Twenty participants attended 99.4% of sessions and completed a high number of repetitions. Participants reported high satisfaction and low pain, and they demonstrated small, significant improvements in upper-extremity use (before Bonferroni corrections; t = –2.1, p = .04, d = .30), function (t = –3.0, p < .01, d = .20), and attention (t = –3.4, p < .01, d = –.44). CONCLUSION. Repetitive task-specific practice is feasible and tolerable for people with USN. Improvements in upper-extremity use, function, and attention may be attainable. PMID:27294994

D-cycloserine adjuvant therapy to molindone in the treatment of schizophrenia.

PubMed

Rosse, R B; Fay-McCarthy, M; Kendrick, K; Davis, R E; Deutsch, S I

1996-10-01

This preliminary investigation examined the therapeutic efficacy of two doses of oral D-cycloserine (5 and 15 mg p.o. b.i.d.) administered as an adjuvant to molindone (150 mg p.o. q.d.) in the treatment of schizophrenia. D-Cycloserine is an agonist at the N-methyl-D-aspartate (NMDA) subclass of glutamate receptor complex. An NMDA agonist intervention was studied because of the schizophreniform psychosis precipitated by phencyclidine (PCP), which is a noncompetitive antagonist at the NMDA glutamate receptor. The PCP model of schizophrenia is regarded as the most comprehensive pharmacological model of this disorder. In this preliminary, placebo-controlled, double-blind, parallel-group study, the measures of treatment efficacy were the Brief Psychiatric Rating Scale, Schedule for the Assessment of Negative Symptoms, and Clinical Global Impression Scale. The final scores for each item of the outcome measures employed were based on the consensus of at least two trained raters who were present during each rating interview. In the 13 subjects evaluated, although the D-cycloserine was well tolerated, neither dose seemed to possess adjuvant therapeutic efficacy. However, since another recent report of nine patients with schizophrenia treated for 2 weeks with a slightly higher dose of D-cycloserine (50 mg/day) described significant clinical and neuropsychological improvement, further study of the adjuvant potential of slightly higher doses of D-cycloserine seems warranted. Additionally, there might be a therapeutic window for D-cycloserine dosing, as daily doses of 250 mg have been associated with symptom worsening.

Laboratory investigation of the efficacy of holmium:YAG laser irradiation in removing intracanal debris

NASA Astrophysics Data System (ADS)

Nuebler-Moritz, Michael; Gutknecht, Norbert; Sailer, Hermann F.; Hering, Peter; Prettl, Wilhelm

1997-05-01

Current endodontic therapy involves debridement and disinfection of the root canal by means of mechanical instrumentation and chemical irrigation. However, several studies have shown that these techniques fail to achieve complete cleansing. Recently, lasers have been suggested for use within root canals. This study was conducted to determine the efficacy of Holmium:YAG laser irradiation in removing intracanal debris and smear layer. Root canal surfaces of freshly-extracted human teeth were exposed to pulsed Ho:YAG laser radiation. Subsequently, laser induced structural changes were investigated using scanning electron microscopy. Temperature measurements during irradiation were performed by means of thermocouples. The result of this survey give a preliminary indication of the ability of the Ho:YAG laser to improve current endodontic treatment survey give a preliminary indication of the ability of the Ho:YAG laser to improve current endodontic treatment modalities. However, limitations exist with regard to circumscribed and well-quantified irradiation of root canal surfaces, due to the lack of perpendicular delivery of the laser beam. Additional studies will be required to develop suitable optical transmission systems, in order to achieve complete cleansing and to avoid damage to the periradicular tissues, respectively.

Attentive Reading With Constrained Summarization Adapted to Address Written Discourse in People With Mild Aphasia.

PubMed

Obermeyer, Jessica A; Edmonds, Lisa A

2018-03-01

The purpose of this study was to examine the preliminary efficacy of Attentive Reading and Constrained Summarization-Written (ARCS-W) in people with mild aphasia. ARCS-W adapts an existing treatment, ARCS (Rogalski & Edmonds, 2008), to address discourse level writing in mild aphasia. ARCS-W focuses on the cognitive and linguistic skills required for discourse production. This study was a within-subject pre-postdesign. Three people with mild aphasia participated. ARCS-W integrates attentive reading or listening with constrained summarization of discourse level material in spoken and written modalities. Outcomes included macro- (main concepts) and microlinguistic (correct information units, complete utterances) discourse measures, confrontation naming, aphasia severity, and functional communication. All 3 participants demonstrated some generalization to untrained spoken and written discourse at the word, sentence, and text levels. Reduced aphasia severity and/or increased functional communication and confrontation naming were also observed in some participants. The findings of this study provide preliminary evidence of the efficacy of ARCS-W to improve spoken and written discourse in mild aphasia. Different generalization patterns suggest different mechanisms of improvement. Further research and replication are required to better understand how ARCS-W can impact discourse abilities.

Reliability and responsiveness of the Self-Efficacy in Assessing, Training and Spotting wheelchair skills (SEATS) outcome measure.

PubMed

Rushton, Paula W; Smith, Emma M; Miller, William C; Kirby, R Lee; Daoust, Geneviève

2018-01-31

The aim of this study was to evaluate the internal consistency, test-retest reliability and responsiveness of the Self-Efficacy in Assessing, Training and Spotting manual wheelchair skills (SEATS-M) and Self-Efficacy in Assessing, Training and Spotting power wheelchair skills (SEATS-P). A 2-week test-retest design was used with a convenience sample of occupational and physical therapists who worked at a provincial rehabilitation centre (inpatient and outpatient services). Sixteen participants completed the SEATS-M and 18 participants completed the SEATS-P. For the SEATS-M assessment, training, spotting and documentation sections, Cronbach's alpha coefficients ranged from 0.90 to 0.97, the 2-week intraclass correlation coefficients (ICC 1,1 ) ranged from 0.81 to 0.95, the standard error of measurements (SEM) ranged from 5.06 to 8.70 and the smallest real differences (SRD) ranged from 6.24 to 8.18. For the SEATS-P assessment, training, spotting and documentation sections, Cronbach's alpha coefficients ranged from 0.83 to 0.92, the ICCs ranged from 0.72 to 0.86, the SEMs ranged from 4.54 to 8.91 and the SRDs ranged from 5.90 to 8.27. There is preliminary evidence that both the SEATS-M and the SEATS-P have high internal consistency, good test-retest reliability and support for responsiveness. These tools can be used in evaluating clinician self-efficacy with assessing, training, spotting and documenting wheelchair skills included on the Wheelchair Skills Test. Implications for Rehabilitation There is preliminary evidence that the SEATS-M and SEATS-P are reliable and responsive outcome measures that can be used to evaluate the self-efficacy of clinicians to administer the Wheelchair Skills Program. Measurement of clinicians' self-efficacy in this area of practice may enable an enhanced understanding of the areas in which clinicians lack self-efficacy, thereby informing the development of improved knowledge translation interventions.

Game-Based Cognitive-Behavioral Therapy (GB-CBT) Group Program for Children Who Have Experienced Sexual Abuse: A Preliminary Investigation

ERIC Educational Resources Information Center

Misurell, Justin R.; Springer, Craig; Tryon, Warren W.

2011-01-01

This preliminary investigation examined the efficacy of a game-based cognitive-behavioral therapy group program for elementary school-aged children who have experienced sexual abuse. Treatment aimed to improve: (a) internalizing symptoms, (b) externalizing behaviors, (c) sexually inappropriate behaviors, (d) social skills deficits, (e) self-esteem…

Self-Efficacy Buffers the Relationship between Educational Disadvantage and Executive Functioning

PubMed Central

Zahodne, Laura B.; Nowinski, Cindy J.; Gershon, Richard C.; Manly, Jennifer J.

2016-01-01

Objective Previous studies showed that control beliefs are more strongly related to global cognition and mortality among adults with low education, providing preliminary evidence that self-efficacy buffers against the negative impact of educational disadvantage on physical and cognitive health. The current study extends these findings to a nationally-representative sample of men and women aged 30 to 85 and explores which cognitive domains are most strongly associated with self-efficacy, educational attainment, and their interaction. Method Data were obtained from 1,032 adult (30-85) participants in the United States norming study for the NIH Toolbox. Self-efficacy, executive functioning, working memory, processing speed, episodic memory, and vocabulary were assessed with the NIH Toolbox. Multivariate analysis of covariance and follow-up regressions tested the hypothesis that self-efficacy would be more strongly related to cognitive performance among individuals with lower education, controlling for age, sex, race, ethnicity, education, reading level, testing language, and depressive symptoms. Results Higher education was associated with higher self-efficacy and better performance on all cognitive tests. Higher self-efficacy was associated with better set-switching and attention/inhibition. Significant self-efficacy by education interactions indicated that associations between self-efficacy and executive abilities were stronger for individuals with lower education. Specifically, individuals with low education but high self-efficacy performed similarly to individuals with high education. Conclusions This study provides evidence that self-efficacy beliefs buffer against the negative effects of low educational attainment on executive functioning. These results have implications for future policy and/or intervention work aimed at reducing the deleterious effects of educational disadvantage on later cognitive health. PMID:25877284

A Randomized Controlled Trial of the Child Anxiety Multi-Day Program (CAMP) for Separation Anxiety Disorder

ERIC Educational Resources Information Center

Santucci, Lauren C.; Ehrenreich-May, Jill

2013-01-01

While the efficacy of cognitive behavior therapy for childhood anxiety disorders, including separation anxiety disorder (SAD), has been established, tailoring such treatments to particular interests and needs may enhance uptake of evidence-based interventions. The current investigation evaluates the feasibility and preliminary efficacy of an…

Development of a Drug Use Resistance Self-Efficacy (DURSE) Scale

ERIC Educational Resources Information Center

Carpenter, Carrie M.; Howard, Donna

2009-01-01

Objectives: To develop and evaluate psychometric properties of a new instrument, the drug use resistance self-efficacy (DURSE) scale, designed for young adolescents. Methods: Scale construction occurred in 3 phases: (1) initial development, (2) pilot testing of preliminary items, and (3) final scale administration among a sample of seventh graders…

Connecting Students to Mental Health Care: Pilot Findings from an Engagement Program for School Nurses

ERIC Educational Resources Information Center

Kim, Rachel E.; Becker, Kimberly D.; Stephan, Sharon H.; Hakimian, Serop; Apocada, Dee; Escudero, Pia V.; Chorpita, Bruce F.

2015-01-01

Schools function as the major provider of mental health services (MHS) for youth, but can struggle with engaging them in services. School nurses are well-positioned to facilitate referrals for MHS. This pilot study examined the feasibility, acceptability, and preliminary efficacy of an engagement protocol (EP) designed to enhance school nurses'…

Brief Report: Problem Solving Therapy in College Students with Autism Spectrum Disorders: Feasibility and Preliminary Efficacy

ERIC Educational Resources Information Center

Pugliese, Cara E.; White, Susan W.

2014-01-01

Students with autism spectrum disorder (ASD), though academically capable, can have difficulty succeeding in college. Evidence-based intervention to promote effective problem solving may improve quality of life, as well as success and satisfaction in college. This study adapted and piloted a group-based cognitive-behavioral intervention program,…

The Effect of Films with and without Subtitles on Listening Comprehension of EFL Learners

ERIC Educational Resources Information Center

Hayati, Abdolmajid; Mohmedi, Firooz

2011-01-01

The present study represented a preliminary effort to empirically examine the efficacy of subtitled movie on listening comprehension of intermediate English as a Foreign Language students. To achieve this purpose, out of a total of 200 intermediate students, 90 were picked based on a proficiency test. The material consisted of six episodes…

Use of Text Messaging for Monitoring Sugar-Sweetened Beverages, Physical Activity, and Screen Time in Children: A Pilot Study

ERIC Educational Resources Information Center

Shapiro, Jennifer R.; Bauer, Stephanie; Hamer, Robert M.; Kordy, Hans; Ward, Dianne; Bulik, Cynthia M.

2008-01-01

Objective: To examine acceptability, attrition, adherence, and preliminary efficacy of mobile phone short message service (SMS; text messaging) for monitoring healthful behaviors in children. Design: All randomized children received a brief psychoeducational intervention. They then either monitored target behaviors via SMS with feedback or via…

A Pilot Study of Strong Start: Preliminary Evidence of Feasibiliy and Efficacy of Social and Emotional Learning in Preschool

ERIC Educational Resources Information Center

Felver, Sarah

2013-01-01

Social and emotional competencies have received increased attention as important components of school readiness for young children. Universal programs incorporating social and emotional learning (SEL) instruction for all preschool students are needed given the relation between social and emotional competencies in early childhood and later…

STX209 (Arbaclofen) for Autism Spectrum Disorders: An 8-Week Open-Label Study

ERIC Educational Resources Information Center

Erickson, Craig A.; Veenstra-Vanderweele, Jeremy M.; Melmed, Raun D.; McCracken, James T.; Ginsberg, Lawrence D.; Sikich, Linmarie; Scahill, Lawrence; Cherubini, Maryann; Zarevics, Peter; Walton-Bowen, Karen; Carpenter, Randall L.; Bear, Mark F.; Wang, Paul P.; King, Bryan H.

2014-01-01

STX209 (arbaclofen), a selective GABA-B agonist, is hypothesized to modulate the balance of excitatory to inhibitory neurotransmission, and has shown preliminary evidence of benefit in fragile X syndrome. We evaluated its safety, tolerability, and efficacy in non-syndromic autism spectrum disorders, in an 8-week open-label trial enrolling 32…

Feasibility of a Text-Based Smoking Cessation Intervention in Rural Older Adults

ERIC Educational Resources Information Center

Noonan, D.; Silva, S.; Njuru, J.; Bishop, T.; Fish, L. J.; Simmons, L. A.; Choi, S. H.; Pollak, K. I.

2018-01-01

Text-based interventions are effective for smoking cessation, but have not been tested in rural older adults. The purpose of this study was to compare the feasibility, acceptability and preliminary efficacy of a text-based Scheduled Gradual Reduction (SGR) program to a non-SGR text messaging support condition among rural older adults. Adults over…

Evaluating the Authenticity of Egyptian Cartonnage Fragments: Educational Outreach in Search of the Truth.

ERIC Educational Resources Information Center

Marty, Paul; Sheahan, Kim; Lacy, Ann

This paper presents preliminary results from a five year longitudinal study on the efficacy of integrating museum resources into elementary and middle school curricula through educational outreach activities, over the Internet and in the classroom. From 1997 to 2003, museum educators at the University of Illinois' Spurlock Museum have explored how…

Preliminary Effects of the Incredible Years Teacher Training Program on Classroom Management Skills

ERIC Educational Resources Information Center

Murray, Desiree W.; Murr, Natalie; Rabiner, David L.

2012-01-01

The overall purpose of this IES-funded Goal 3 study, now entering its third year, is to evaluate the efficacy of Incredible Years Teacher program (IYT) for improving K-2 students' academic achievement, attention, and social-emotional competence. The authors will also examine the extent to which classroom behavior mediates the relationship between…

Development and psychometric evaluation of an information literacy self-efficacy survey and an information literacy knowledge test.

PubMed

Tepe, Rodger; Tepe, Chabha

2015-03-01

To develop and psychometrically evaluate an information literacy (IL) self-efficacy survey and an IL knowledge test. In this test-retest reliability study, a 25-item IL self-efficacy survey and a 50-item IL knowledge test were developed and administered to a convenience sample of 53 chiropractic students. Item analyses were performed on all questions. The IL self-efficacy survey demonstrated good reliability (test-retest correlation = 0.81) and good/very good internal consistency (mean κ = .56 and Cronbach's α = .92). A total of 25 questions with the best item analysis characteristics were chosen from the 50-item IL knowledge test, resulting in a 25-item IL knowledge test that demonstrated good reliability (test-retest correlation = 0.87), very good internal consistency (mean κ = .69, KR20 = 0.85), and good item discrimination (mean point-biserial = 0.48). This study resulted in the development of three instruments: a 25-item IL self-efficacy survey, a 50-item IL knowledge test, and a 25-item IL knowledge test. The information literacy self-efficacy survey and the 25-item version of the information literacy knowledge test have shown preliminary evidence of adequate reliability and validity to justify continuing study with these instruments.

Development and psychometric evaluation of an information literacy self-efficacy survey and an information literacy knowledge test*

PubMed Central

Tepe, Rodger; Tepe, Chabha

2015-01-01

Objective To develop and psychometrically evaluate an information literacy (IL) self-efficacy survey and an IL knowledge test. Methods In this test–retest reliability study, a 25-item IL self-efficacy survey and a 50-item IL knowledge test were developed and administered to a convenience sample of 53 chiropractic students. Item analyses were performed on all questions. Results The IL self-efficacy survey demonstrated good reliability (test–retest correlation = 0.81) and good/very good internal consistency (mean κ = .56 and Cronbach's α = .92). A total of 25 questions with the best item analysis characteristics were chosen from the 50-item IL knowledge test, resulting in a 25-item IL knowledge test that demonstrated good reliability (test–retest correlation = 0.87), very good internal consistency (mean κ = .69, KR20 = 0.85), and good item discrimination (mean point-biserial = 0.48). Conclusions This study resulted in the development of three instruments: a 25-item IL self-efficacy survey, a 50-item IL knowledge test, and a 25-item IL knowledge test. The information literacy self-efficacy survey and the 25-item version of the information literacy knowledge test have shown preliminary evidence of adequate reliability and validity to justify continuing study with these instruments. PMID:25517736

Scrambler therapy efficacy and safety for neuropathic pain correlated with chemotherapy-induced peripheral neuropathy in adolescents: A preliminary study.

PubMed

Tomasello, Caterina; Pinto, Rita Maria; Mennini, Chiara; Conicella, Elena; Stoppa, Francesca; Raucci, Umberto

2018-04-06

Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of chemotherapy, in need of effective treatment. Preliminary data support the efficacy of scrambler therapy (ST), a noninvasive cutaneous electrostimulation device, in adults with CIPN. We test the efficacy, safety, and durability of ST for neuropathic pain in adolescents with CIPN. We studied nine pediatric patients with cancer and CIPN who received ST for pain control. Each patient received 45-min daily sessions for 10 consecutive days as a first step, but some of them required additional treatment. Pain significantly improved comparing Numeric Rate Scale after 10 days of ST (9.22 ± 0.83 vs. 2.33 ± 2.34; P < 0.001) and at the end of the optimized cycle (EOC) (9.22 ± 0.83 vs. 0.11 ± 0.33, P < 0.001). The improvement in quality of life was significantly reached on pain interference with general activity (8.67 ± 1.66 vs. 3.33 ± 2.12, P < 0.0001), mood (8.33 ± 3.32 vs. 2.78 ± 2.82, P < 0.0005), walking ability (10.00 vs. 2.78 ± 1.22, P < 0.0001), sleep (7.56 ± 2.24 vs. 2.67 ± 1.41, P < 0.001), and relations with people (7.89 ± 2.03 vs. 2.11 ± 2.03, P < 0.0002; Lansky score 26.7 ± 13.2 vs. 10 days of ST 57.8 ± 13.9, P < 0.001; 26.7 ± 13.2 vs. EOC 71.1 ± 16.2, P < 0.001). Based on these preliminary data, ST could be a good choice for adolescents with CIPN for whom pain control is difficult. ST caused total relief or dramatic reduction in CIPN pain and an improvement in quality of life, durable in follow-up. It caused no detected side effects, and can be retrained successfully. Further larger studies should be performed to confirm our promising preliminary data in pediatric patients with cancer. © 2018 Wiley Periodicals, Inc.

Minimally invasive periodontal therapy

PubMed Central

Dannan, Aous

2011-01-01

Minimally invasive dentistry is a concept that preserves dentition and supporting structures. However, minimally invasive procedures in periodontal treatment are supposed to be limited within periodontal surgery, the aim of which is to represent alternative approaches developed to allow less extensive manipulation of surrounding tissues than conventional procedures, while accomplishing the same objectives. In this review, the concept of minimally invasive periodontal surgery (MIPS) is firstly explained. An electronic search for all studies regarding efficacy and effectiveness of MIPS between 2001 and 2009 was conducted. For this purpose, suitable key words from Medical Subject Headings on PubMed were used to extract the required studies. All studies are demonstrated and important results are concluded. Preliminary data from case cohorts and from many studies reveal that the microsurgical access flap, in terms of MIPS, has a high potential to seal the healing wound from the contaminated oral environment by achieving and maintaining primary closure. Soft tissues are mostly preserved and minimal gingival recession is observed, an important feature to meet the demands of the patient and the clinician in the esthetic zone. However, although the potential efficacy of MIPS in the treatment of deep intrabony defects has been proved, larger studies are required to confirm and extend the reported positive preliminary outcomes. PMID:22368356

Supportive treatment for children with the common cold.

PubMed

Ballengee, Cortney R; Turner, Ronald B

2014-02-01

This review summarizes recent developments in the supportive treatment of common cold symptoms in children. Conventional common cold therapies are no longer recommended for use in young children because of safety concerns. There are no studies that convincingly demonstrate the efficacy of any therapy for treatment of common cold symptoms in children less than 6 years of age and it is unlikely studies that establish efficacy can be done. Recent studies report a significant effect of probiotics on the occurrence of common cold illnesses in children, and studies in animals provide a plausible mechanism of action. These data suggest that the use of probiotics may have promise for the prevention of common cold illnesses in children. The effect of treatment on the severity of common cold symptoms cannot be accurately assessed with current study designs. In the absence of convincing evidence of efficacy, treatment of young children with symptomatic therapies cannot be recommended. Preliminary data suggest a small, beneficial effect of probiotics for the prevention of common cold illness.

Rhodiola rosea therapy for major depressive disorder: a study protocol for a randomized, double-blind, placebo- controlled trial

PubMed Central

Mao, Jun J; Li, Qing S.; Soeller, Irene; Xie, Sharon X; Amsterdam, Jay D.

2014-01-01

Background Rhodiola rosea (R. rosea), a botanical of both western and traditional Chinese medicine, has been used as a folk remedy for improving stamina and reducing stress. However, few controlled clinical trials have examined the safety and efficacy of R. rosea for the treatment of major depressive disorder (MDD). This study seeks to evaluate the safety and efficacy of R. rosea in a 12-week, randomized, double-blind, placebo-controlled, parallel group study design. Methods / Design Subjects with MDD not receiving antidepressant therapy will be randomized to either R. rosea extract 340–1,360 mg daily; sertraline 50–200 mg daily, or placebo for 12 weeks. The primary outcome measure will be change over time in the mean 17-item Hamilton Depression Rating score. Secondary outcome measures will include safety and quality of life ratings. Statistical procedures will include mixed-effects models to assess efficacy for primary and secondary outcomes. Discussion This study will provide valuable preliminary information on the safety and efficacy data of R. rosea versus conventional antidepressant therapy of MDD. It will also inform additional hypotheses and study design of future, fully powered, phase III clinical trials with R. rosea to determine its safety and efficacy in MDD. PMID:25610752

Intensive, Manual-based Intervention for Pediatric Feeding Disorders: Results From a Randomized Pilot Trial.

PubMed

Sharp, William G; Stubbs, Kathryn H; Adams, Heyward; Wells, Brian M; Lesack, Roseanne S; Criado, Kristen K; Simon, Elizabeth L; McCracken, Courtney E; West, Leanne L; Scahill, Larry D

2016-04-01

The aim of this pilot study was to investigate feasibility and preliminary efficacy of an intensive, manual-based behavioral feeding intervention for children with chronic food refusal and dependence on enteral feeding or oral nutritional formula supplementation. Twenty children ages 13 to 72 months (12 boys and 8 girls) meeting criteria for avoidant/restrictive food intake disorder were randomly assigned to receive treatment for 5 consecutive days in a day treatment program (n = 10) or waitlist (n = 10). A team of trained therapists implemented treatment under the guidance of a multidisciplinary team. Parent training was delivered to support generalization of treatment gains. We tracked parental attrition and attendance, as well as therapist fidelity. Primary outcome measures were bite acceptance, disruptions, and grams consumed during meals. Caregivers reported high satisfaction and acceptability of the intervention. Three participants (1 intervention; 2 waitlist) dropped out of the study before endpoint. Of the expected 140 treatment meals for the intervention group, 137 (97.8%) were actually attended. The intervention group showed significantly greater improvements (P < 0.05) on all primary outcome measures (d = 1.03-2.11) compared with waitlist (d = -1.13-0.24). A 1-month follow-up suggested stability in treatment gains. Results from this pilot study corroborate evidence from single-subject and nonrandomized studies on the positive effects of behavioral intervention. Findings support the feasibility and preliminary efficacy of this manual-based approach to intervention. These results warrant a large-scale randomized trial to test the safety and efficacy of this intervention.

Preliminary efficacy and safety of an oromucosal standardized cannabis extract in chemotherapy-induced nausea and vomiting.

PubMed

Duran, Marta; Pérez, Eulàlia; Abanades, Sergio; Vidal, Xavier; Saura, Cristina; Majem, Margarita; Arriola, Edurne; Rabanal, Manel; Pastor, Antoni; Farré, Magí; Rams, Neus; Laporte, Joan-Ramon; Capellà, Dolors

2010-11-01

Despite progress in anti-emetic treatment, many patients still suffer from chemotherapy-induced nausea and vomiting (CINV). This is a pilot, randomized, double-blind, placebo-controlled phase II clinical trial designed to evaluate the tolerability, preliminary efficacy, and pharmacokinetics of an acute dose titration of a whole-plant cannabis-based medicine (CBM) containing delta-9-tetrahydrocannabinol and cannabidiol, taken in conjunction with standard therapies in the control of CINV. Patients suffering from CINV despite prophylaxis with standard anti-emetic treatment were randomized to CBM or placebo, during the 120 h post-chemotherapy period, added to standard anti-emetic treatment. Tolerability was measured as the number of withdrawals from the study during the titration period because of adverse events (AEs). The endpoint for the preliminary efficacy analysis was the proportion of patients showing complete or partial response. Seven patients were randomized to CBM and nine to placebo. Only one patient in the CBM arm was withdrawn due to AEs. A higher proportion of patients in the CBM group experienced a complete response during the overall observation period [5/7 (71.4%) with CMB vs. 2/9 (22.2%) with placebo, the difference being 49.2% (95% CI 1%, 75%)], due to the delayed period. The incidence of AEs was higher in the CBM group (86% vs. 67%). No serious AEs were reported. The mean daily dose was 4.8 sprays in both groups. Compared with placebo, CBM added to standard antiemetic therapy was well tolerated and provided better protection against delayed CINV. These results should be confirmed in a phase III clinical trial. © 2010 Department of Health, Generalitat of Catalonia. British Journal of Clinical Pharmacology © 2010 The British Pharmacological Society.

Efficacy of Attention Regulation in Preschool-Age Children Who Stutter: A Preliminary Investigation

ERIC Educational Resources Information Center

Johnson, Kia N.; Conture, Edward G.; Walden, Tedra A.

2012-01-01

Purpose: This preliminary investigation assessed the attentional processes of preschool-age children who do (CWS) and do not stutter (CWNS) during Traditional cueing and Affect cueing tasks. Method: Participants consisted of 12 3- to 5-year-old CWS and the same number of CWNS (all boys). Both talker groups participated in two tasks of shifting and…

Preliminary Evaluation of Commercial Off the Shelf (COTS) Packing Materials for Flight Medication Dispenser (FMD) Technology Development

NASA Technical Reports Server (NTRS)

Du, B.; Daniels, V.; Crady, C.; Putcha, L.

2011-01-01

This slide presentation reviews preliminary results of the program to evaluate Commercial Off the Shelf (COTS) packaging materials for pharmaceutical stability. The need for improved packaging is due to possible changes in chemical and/or physical properties of the drugs, which cause reported reduced potency and/or altered bioavailability and decreased efficacy.

Preliminary Investigation of the Sources of Self-Efficacy among Teachers of Students with Autism

ERIC Educational Resources Information Center

Ruble, Lisa A.; Usher, Ellen L.; McGrew, John H.

2011-01-01

Teacher self-efficacy refers to the beliefs teachers hold regarding their capability to bring about desired instructional outcomes and may be helpful for understanding and addressing critical issues such as teacher attrition and teacher use of research-supported practices. Educating students with autism likely presents teachers with some of the…

Psychometrics of a Brief Measure of Emotional Self-Efficacy among Adolescents from the United States

ERIC Educational Resources Information Center

Valois, Robert F.; Zullig, Keith J.

2013-01-01

Background: Preliminary data were collected to evaluate the psychometric properties of an emotional self-efficacy (ESE) measure in a sample of 3836 public high school adolescents who completed the Centers for Disease Control and Prevention (CDC) Youth Risk Behavior Survey in South Carolina. Methods: Principal axis factor analysis was followed by a…

[Enhancing development of children at risk and their parents by video counselling according to the Marte Meo method].

PubMed

Bünder, Peter

2011-01-01

Marte Meo is a low-intensity programme of counselling parents and other persons significantly involved with children which aims to foster parenting capacity and facilitate child development. The article describes a preliminary pilot study with the aim of identifying variables for the future evaluation of efficacy and effectiveness of the Marte Meo method.

Improving Academic Self-Efficacy, School Connectedness, and Identity in Struggling Middle School Girls: A Preliminary Study of the "REAL Girls" Program

ERIC Educational Resources Information Center

Mann, Michael J.; Smith, Megan L.; Kristjansson, Alfgeir L.

2015-01-01

Girls struggling to be successful in middle school are often dealing with negative life experiences that affect their ability to achieve academically. Frequently, their academic failures and problem behaviors are associated with feeling overwhelmed by difficult and challenging life circumstances. In the absence of intervention, these patterns may…

Some Nigerian Anti-Tuberculosis Ethnomedicines: A Preliminary Efficacy Assessment

PubMed Central

Ibekwe, Nneka N.; Nvau, John B.; Oladosu, Peters O.; Usman, Auwal M.; Ibrahim, Kolo; Boshoff, Helena I.; Dowd, Cynthia S.; Orisadipe, Abayomi T.; Aiyelaagbe, Olapeju; Adesomoju, Akinbo A.; Barry, Clifton E.; Okogun, Joseph I.

2014-01-01

Ethnopharmacological significance Nigerian herbalists possess indigenous ethnomedicinal recipes for the management of tuberculosis and related ailments. Aim of the study To carry out a collaborative preliminary modern scientific evaluation of the efficacy of some Nigerian ethnomedicines used by traditional medicine practitioners (TMPs) in the management of tuberculosis and related ailments Materials and methods Ethnomedicinal recipes (ETMs) were collected from TMPs from locations in various ecological zones of Nigeria under a collaborative understanding. The aqueous methanolic extracts of the ETMs were screened against Mycobacterium bovis, BCG and Mycobacterium tuberculosis (M. tb.) strain H37Rv using the broth microdilution method. Results Extracts of ETMs screened against BCG showed 69% activity against the organism. The activities varied from weak, ≤ 2500μg /mL to highly active, 33μg /mL 64% of the extracts were active against M. tb. The activities of the extracts against M.tb. varied from weak, ≤ 2500μg /mL to highly active, 128μg/mL. There was 77% agreement in results obtained using BCG or M. tb. as test organisms Conclusion The results show clear evidence for the efficacy of the majority of indigenous Nigerian herbal recipes in the ethnomedicinal management of tuberculosis and related ailments. BCG may be effectively used, to a great extent, as the organism for screening for potential anti-M. tb. agents. A set of prioritization criteria for the selection of plants for initial further studies for the purpose of antituberculsis drug discovery research is proposed. PMID:24911338

Preliminary antifungal activity assay of selected chlorine-containing derivatives of xanthone and phenoxyethyl amines.

PubMed

Klesiewicz, Karolina; Żelaszczyk, Dorota; Trojanowska, Danuta; Bogusz, Bożena; Małek, Marianna; Waszkielewicz, Anna; Szkaradek, Natalia; Karczewska, Elżbieta; Marona, Henryk; Budak, Alicja

2018-06-20

The aim of this study was to preliminary evaluate antifungal activity diverse group of chlorine-containing xanthone and phenoxyethyl amine derivatives - and to select most promising compounds for further studies. The antifungal efficacy of 16 compounds was tested with qualitative and quantitative methods against both reference and clinical strains of dermatophytes, moulds and yeasts. The disc-diffusion method has demonstrated that from 16 tested compounds, 7 possess good antifungal activity against dermatophytes and/or moulds while none of them has shown good efficacy against yeasts or bacterial strains. The most active compounds (2, 4, 10, 11, 12, 15, 16) were tested quantitatively by broth dilution method to obtain MIC values. The MIC values against dermatophytes ranged from 8 to 64 μg/mL. Compound 2 was the most active one against dermatophytes (MIC 50 and MIC 90 were 8 μg/mL). The MIC values for moulds ranged from 16 to 256 μg/mL. Compound 4 was the most active one against moulds, with MIC 50 and MIC 90 values amounting to 32 μg/mL. Among the tested compounds, compound 4 (derivative of xanthone) was the most active one and expressed good antifungal efficacy against clinical strains of dermatophytes and moulds. However, another xanthone derivative (compound 2) was the most active and selective against dermatophytes. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

A randomized, double-blind, placebo-controlled, pilot study to assess the efficacy and safety of clindamycin 1.2% and tretinoin 0.025% combination gel for the treatment of acne rosacea over 12 weeks.

PubMed

Chang, Anne Lynn S; Alora-Palli, Maria; Lima, Xinaida T; Chang, Tiffany C; Cheng, Carol; Chung, Connie M; Amir, Omar; Kimball, Alexa B

2012-03-01

Papulopustular acne rosacea is a chronic inflammatory condition which can be difficult to treat. Many patients are unwilling to use systemic medications, and single topical agents alone may not address all the symptoms of rosacea. A combination topical clindamycin phosphate 1.2% and tretinoin 0.025% gel is efficacious for acne vulgaris, and may be helpful for rosacea, since acne vulgaris and rosacea shares many similar clinical and histologic features. To assess the preliminary efficacy and safety of a combination gel consisting of clindamycin phosphate 1.2% and tretinoin 0.025% on papulopustular rosacea after 12 weeks of usage. Randomized, double-blind, placebo controlled two site study of 79 participants with moderate to severe papulopustular acne rosacea using both physician and subjects' validated assessment tools. Primary endpoint consisted of statistically significant reduction in absolute papule or pustule count after 12 weeks of usage. There was no significant difference in papule/pustule count between placebo and treated groups after 12 weeks (P=0.10). However, there was nearly significant improvement in physicians' assessments of the telangiectasia component of rosacea (P=0.06) and erythematotelangiectatic rosacea subtype (P=0.05) in treated versus placebo group after 12 weeks. The only significant adverse event different was facial scaling, which was significantly increased in treated group (P=0.01), but this did not result in discontinuation of study drug. A combination gel of clindamycin phosphate 1.2% and tretinoin 0.025% may improve the telangiectatic component of rosacea and appears to better treat the erythemotelangiectatic subtype of rosacea rather than papulopustular subtype. Our preliminary study suggests that future studies with much larger sample size might confirm our findings.

Preliminary stop of the TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC) trial.

PubMed

Koeneman, M M; Kruse, A J; Kooreman, L F S; Zur Hausen, A; Hopman, A H N; Sep, S J S; Van Gorp, T; Slangen, B F M; van Beekhuizen, H J; van de Sande, A J M; Gerestein, C G; Nijman, H W; Kruitwagen, R F P M

2017-02-07

The "TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia" (TOPIC) trial was stopped preliminary, due to lagging inclusions. This study aimed to evaluate the treatment efficacy and clinical applicability of imiquimod 5% cream in high-grade cervical intraepithelial neoplasia (CIN). The lagging inclusions were mainly due to a strong patient preference for either of the two treatment modalities. This prompted us to initiate a new study on the same subject, with a non-randomized, open-label design: the 'TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC)-3' study. Original TOPIC-trial: Medical Ethics Committee approval number METC13231; ClinicalTrials.gov Identifier: NCT02329171, 22 December 2014. TOPIC-3 study: Medical Ethics Committee approval number METC162025; ClinicalTrials.gov Identifier: NCT02917746, 16 September 2016.

An analysis of contingency statements in a DRO procedure: A case report.

PubMed

Gerow, Stephanie; Rispoli, Mandy; Boles, Margot B; Neely, Leslie C

2015-06-01

To examine latency to criterion for reduction of challenging behaviour with and without stating a contingency statement immediately prior to a DRO procedure. An ABAC design in which A was baseline, B was used to evaluate the efficacy of a DRO procedure, and C was used to evaluate the efficacy of a DRO procedure with a contingency statement. The DRO with the contingency statement intervention was associated with a shorter latency to behaviour change than the DRO procedure without the contingency statement. These preliminary findings from this case study highlight the importance of examining the efficiency of behaviour change procedures. Directions for future research are provided.

The Role of Empowerment in a School-Based Community Service Program with Inner-City, Minority Youth

PubMed Central

Gullan, Rebecca L.; Power, Thomas J.; Leff, Stephen S.

2014-01-01

Despite considerable fiscal and structural support for youth service programs, research has not demonstrated consistent outcomes across participants or programs, suggesting the need to identify critical program processes. The present study addresses this need through preliminary examination of the role of program empowerment in promoting positive identity development in inner-city, African American youth participating in a pilot school-based service program. Results suggest that participants who experienced the program as empowering experienced increases in self-efficacy, sense of civic responsibility, and ethnic identity, over and above general engagement and enjoyment of the program. Preliminary exploration of differences based on participant gender suggests that some results may be stronger and more consistent for males than females. These findings provide preliminary support for the importance of theoretically grounded program processes in producing positive outcomes for youth service participants. PMID:25104875

Production and characterization of cosmetic nanoemulsions containing Opuntia ficus-indica (L.) mill extract as moisturizing agent.

PubMed

Ribeiro, Renato Cesar de Azevedo; Barreto, Stella Maria de Andrade Gomes; Ostrosky, Elissa Aarantes; da Rocha-Filho, Pedro Alves; Veríssimo, Lourena Mafra; Ferrari, Márcio

2015-02-02

This study aimed to produce and characterize an oil in water (O/W) nanoemulsion containing Opuntia ficus-indica (L.) Mill hydroglycolic extract, as well as evaluate its preliminary and accelerated thermal stability and moisturizing efficacy. The formulations containing 0.5% of xanthan gum (FX) and 0.5% of xanthan gum and 1% of Opuntia ficus-indica MILL extract (FXE) were white, homogeneus and fluid in aspect. Both formulations were stable during preliminary and accelerated stability tests. FX and FXE presented a pH compatible to skin pH (4.5-6.0); droplet size varying from 92.2 to 233.6 nm; a polydispersion index (PDI) around 0.200 and a zeta potential from -26.71 to -47.01 mV. FXE was able to increase the water content of the stratum corneum for 5 h after application on the forearm. The O/W nanoemulsions containing 1% of Opuntia ficus-indica (L.) Mill extract presented suitable stability for at least for 60 days. Besides, this formulation was able to increase the water content of stratum corneum, showing its moisturizing efficacy.

App-guided exposure and response prevention for obsessive compulsive disorder: an open pilot trial.

PubMed

Boisseau, Christina L; Schwartzman, Carly M; Lawton, Jessica; Mancebo, Maria C

2017-11-01

Although effective treatments for obsessive-compulsive disorder (OCD) exist, there are significant barriers to receiving evidence-based care. Mobile health applications (Apps) offer a promising way of overcoming these barriers by increasing access to treatment. The current study investigated the feasibility, acceptability, and preliminary efficacy of LiveOCDFree, an App designed to help OCD patients conduct exposure and response prevention (ERP). Twenty-one participants with mild to moderate symptoms of OCD were enrolled in a 12-week open trial of App-guided self-help ERP. Self-report assessments of OCD, depression, anxiety, and quality of life were completed at baseline, mid-treatment, and post-treatment. App-guided ERP was a feasible and acceptable self-help intervention for individuals with OCD, with high rates of retention and satisfaction. Participants reported significant improvement in OCD and anxiety symptoms pre- to post-treatment. Findings suggest that LiveOCDFree is a feasible and acceptable self-help intervention for OCD. Preliminary efficacy results are encouraging and point to the potential utility of mobile Apps in expanding the reach of existing empirically supported treatments.

Virtual reality for the induction of positive emotions in the treatment of fibromyalgia: a pilot study over acceptability, satisfaction, and the effect of virtual reality on mood.

PubMed

Herrero, Rocio; García-Palacios, Azucena; Castilla, Diana; Molinari, Guadalupe; Botella, Cristina

2014-06-01

One of the most important aspects of fibromyalgia syndrome (FMS) is its impact on quality of life, increasing negative emotions and dysfunctional coping strategies. One of these strategies is to avoid activities, especially meaningful activities, which reduces positive reinforcement. Commencing significant daily activities could enable chronic patients to experience a more fulfilling life. However, the main difficulty found in FMS patients is their willingness to start those activities. Promoting positive emotions could enhance activity management. The aim of this paper is to present a description of a system along with data regarding the acceptability, satisfaction, and preliminary efficacy of a virtual reality (VR) environment for the promotion of positive emotions. The VR environment was especially designed for chronic pain patients. Results showed significant increases in general mood state, positive emotions, motivation, and self-efficacy. These preliminary findings show the potential of VR as an adjunct to the psychological treatment of such an important health problem as chronic pain.

A feasibility study of a personalized, internet-based compliance system for chronic disease management.

PubMed

Wang, X H; Istepanian, R S H; Geake, T; Hayes, J; Desco, M; Kontaxakis, G; Santos, A; Prentza, A; Pavlopoulos, S

2005-10-01

This paper describes a feasibility study on an Internet-based compliance system to provide personalized care for patients suffering from chronic diseases. Relevant medical trials from three different European countries provided preliminary evidence of the feasibility of the system and its efficacy in helping patients to manage their diseases at home. The study discusses further improvements not only for the C-Monitor system, but also for other Internet-based health-care services.

Preliminary Study of the Autism Self-Efficacy Scale for Teachers (ASSET).

PubMed

Ruble, Lisa A; Toland, Michael D; Birdwhistell, Jessica L; McGrew, John H; Usher, Ellen L

2013-09-01

The purpose of the current study was to evaluate a new measure, the Autism Self-Efficacy Scale for Teachers (ASSET) for its dimensionality, internal consistency, and construct validity derived in a sample of special education teachers ( N = 44) of students with autism. Results indicate that all items reflect one dominant factor, teachers' responses to items were internally consistent within the sample, and compared to a 100-point scale, a 6-point response scale is adequate. ASSET scores were found to be negatively correlated with scores on two subscale measures of teacher stress (i.e., self-doubt/need for support and disruption of the teaching process) but uncorrelated with teacher burnout scores. The ASSET is a promising tool that requires replication with larger samples.

Cannabinoids: is there a potential treatment role in epilepsy?

PubMed

Blair, Robert E; Deshpande, Laxmikant S; DeLorenzo, Robert J

2015-01-01

Cannabinoids have been used medicinally for centuries, and in the last decade, attention has focused on their broad therapeutic potential particularly in seizure management. While some cannabinoids have demonstrated anticonvulsant activity in experimental studies, their efficacy for managing clinical seizures has not been fully established. This commentary will touch on our understanding of the brain endocannabinoid system's regulation of synaptic transmission in both physiological and pathophysiological conditions, and review the findings from both experimental and clinical studies on the effectiveness of cannabinoids to suppress epileptic seizures. At present, there is preliminary evidence that non-psychoactive cannabinoids may be useful as anticonvulsants, but additional clinical trials are needed to fully evaluate the efficacy and safety of these compounds for the treatment of epilepsy.

Cannabinoids: is there a potential treatment role in epilepsy?

PubMed Central

Blair, Robert E; Deshpande, Laxmikant S; DeLorenzo, Robert J

2016-01-01

Cannabinoids have been used medicinally for centuries, and in the last decade, attention has focused on their broad therapeutic potential particularly in seizure management. While some cannabinoids have demonstrated anticonvulsant activity in experimental studies, their efficacy for managing clinical seizures has not been fully established. This commentary will touch on our understanding of the brain endocannabinoid system’s regulation of synaptic transmission in both physiological and pathophysiological conditions, and review the findings from both experimental and clinical studies on the effectiveness of cannabinoids to suppress epileptic seizures. At present, there is preliminary evidence that non-psychoactive cannabinoids may be useful as anticonvulsants, but additional clinical trials are needed to fully evaluate the efficacy and safety of these compounds for the treatment of epilepsy. PMID:26234319

Excimer laser photorefractive keratectomy for myopia: preliminary results at one year

NASA Astrophysics Data System (ADS)

Thompson, Keith P.; Waring, George O., III; Steinert, Roger; Durrie, Daniel S.; Gordon, Michael; Brint, Stephen F.

1992-08-01

Excimer laser photorefractive keratectomy (PRK) is presently under investigation for the correction of myopia. Two companies in the United States, Summit Technology (Waltham, Mass.) and VisX, Inc. (Sunnyvale, Calif.) have developed excimer laser delivery systems and are participating in an FDA study to determine the safety and efficacy of PRK. This is a preliminary report on the refractive and visual results of 51 of 100 eyes treated between October 10, 1990 and March 7, 1991 by the Summit Technology UV200LA excimer laser under the FDA Phase IIB FDA protocol one year after surgery. More detailed information on eight patients treated at Emory University Eye Center (Emory Subgroup) is also reported.

Can Botox Injections Relieve Arthritis Pain?

MedlinePlus

... Efficacy of botulinum toxin type A treatment of functional impairment of degenerative hip joint: Preliminary results. Journal of Rehabilitation Medicine. 2010;42:691. Khenioui H, et al. Usefulness ...

Epidural steroid injections: update on efficacy, safety, and newer medications for injection.

PubMed

Kozlov, N; Benzon, H T; Malik, K

2015-08-01

The best evidence for epidural injection appears to be in the setting of radicular pain with epidural steroid and non-steroid injections more efficacious than non-epidural injections. Studies showed the efficacy of non-particulate steroid to approach the efficacy of particulate steroid and very limited comparisons demonstrated no significant difference between epidural steroid and epidural non-steroid (local anesthetic) injection. Preliminary studies evaluating epidural injection of disease modifying anti-rheumatic drugs such etanercept and tocilizumab showed conflicting results and had significant limitations. Randomized studies support better efficacy of transforaminal injection due to greater incidence of ventral epidural spread of injectate when compared to interlaminar injection. Thus, the transforaminal approach is recommended when unilateral radicular pain is limited to one nerve root. However, the transforaminal approach is associated with greater incidence of central nervous system injury, including paraplegia, attributed to embolization of the particulate steroid. Recent studies showed that non-particulate steroids potentially last as long as particulate steroids. Therefore non-particulate steroid should be used in initial transforaminal epidural injection. Future studies should look into the role of adjunct diagnostic aids, including digital subtraction angiography, in detecting intravascular injection and the ideal site of needle placement, whether it is the safe triangle or the triangle of Kambin. Finally, the role of epidural disease -modifying antirheumatic drugs in the management of back pain needs to be better elucidated.

Combined autophagy and HDAC inhibition: a phase I safety, tolerability, pharmacokinetic, and pharmacodynamic analysis of hydroxychloroquine in combination with the HDAC inhibitor vorinostat in patients with advanced solid tumors.

PubMed

Mahalingam, Devalingam; Mita, Monica; Sarantopoulos, John; Wood, Leslie; Amaravadi, Ravi K; Davis, Lisa E; Mita, Alain C; Curiel, Tyler J; Espitia, Claudia M; Nawrocki, Steffan T; Giles, Francis J; Carew, Jennifer S

2014-08-01

We previously reported that inhibition of autophagy significantly augmented the anticancer activity of the histone deacetylase (HDAC) inhibitor vorinostat (VOR) through a cathepsin D-mediated mechanism. We thus conducted a first-in-human study to investigate the safety, preliminary efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of the combination of the autophagy inhibitor hydroxychloroquine (HCQ) and VOR in patients with advanced solid tumors. Of 27 patients treated in the study, 24 were considered fully evaluable for study assessments and toxicity. Patients were treated orally with escalating doses of HCQ daily (QD) (d 2 to 21 of a 21-d cycle) in combination with 400 mg VOR QD (d one to 21). Treatment-related adverse events (AE) included grade 1 to 2 nausea, diarrhea, fatigue, weight loss, anemia, and elevated creatinine. Grade 3 fatigue and/or myelosuppression were observed in a minority of patients. Fatigue and gastrointestinal AE were dose-limiting toxicities. Six-hundred milligrams HCQ and 400 mg VOR was established as the maximum tolerated dose and recommended phase II regimen. One patient with renal cell carcinoma had a confirmed durable partial response and 2 patients with colorectal cancer had prolonged stable disease. The addition of HCQ did not significantly impact the PK profile of VOR. Treatment-related increases in the expression of CDKN1A and CTSD were more pronounced in tumor biopsies than peripheral blood mononuclear cells. Based on the safety and preliminary efficacy of this combination, additional clinical studies are currently being planned to further investigate autophagy inhibition as a new approach to increase the efficacy of HDAC inhibitors.

Psychometric properties of the Spanish version of the Collective Efficacy Questionnaire for Sports.

PubMed

Román Martínez, Julio; Guillén, Félix; Feltz, Deborah

2011-08-01

The present study analyses the psychometric properties of the Spanish version of the Collective Efficacy Questionnaire in Sports (CEQS). The sample comprises 312 athletes (167 males and 145 females), with a mean age of 24.09 (SD= 6.67), with diverse performance levels (professional, semiprofessional and university level), all practitioners of team sports. The factor structure of the questionnaire was analyzed with confirmatory factor analysis (CFA). The results confirm the 5-factor internal structure of the CESQ (Effort, Ability, Unity, Perseverance and Preparation), made up of four items each. We also found acceptable values of the alpha coefficient, which confirms that the CESQ is a reliable instrument. Lastly, we found preliminary support for the validity of the construct of the CESQ, which is sufficient evidence to justify its use to measure the collective efficacy in Spanish athletes.

The Efficacy and Acceptability of Third-Wave Behavioral and Cognitive eHealth Treatments: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

PubMed

O'Connor, Martin; Munnelly, Anita; Whelan, Robert; McHugh, Louise

2018-05-01

eHealth is an innovative method of delivering therapeutic content with the potential to improve access to third-wave behaviural and cognitive therapies. This systematic review and meta-analysis aimed to determine the efficacy and acceptability of third-wave eHealth treatments in improving mental health outcomes. A comprehensive search of electronic bibliographic databases including PubMed, PsycINFO, Web of Science, and CENTRAL was conducted to identify randomized controlled trials of third-wave treatments in which eHealth was the main component. Twenty-one studies were included in the review. Meta-analyses revealed that third-wave eHealth significantly outperformed inactive control conditions in improving anxiety, depression, and quality-of-life outcomes and active control conditions in alleviating anxiety and depression with small to medium effect sizes. No statistically significant differences were found relative to comparison interventions. Findings from a narrative synthesis of participant evaluation outcomes and meta-analysis of participant attrition rates provided preliminary support for the acceptability of third-wave eHealth. Third-wave eHealth treatments are efficacious in improving mental health outcomes including anxiety, depression, and quality of life, but not more so than comparison interventions. Preliminary evidence from indices of participant evaluation and attrition rates supports the acceptability of these treatments. Copyright © 2017. Published by Elsevier Ltd.

Solid lipid nanoparticles by coacervation loaded with a methotrexate prodrug: preliminary study for glioma treatment.

PubMed

Battaglia, Luigi; Muntoni, Elisabetta; Chirio, Daniela; Peira, Elena; Annovazzi, Laura; Schiffer, Davide; Mellai, Marta; Riganti, Chiara; Salaroglio, Iris Chiara; Lanotte, Michele; Panciani, Pierpaolo; Capucchio, Maria Teresa; Valazza, Alberto; Biasibetti, Elena; Gallarate, Marina

2017-03-01

Methotrexate-loaded biocompatible nanoparticles were tested for preliminary efficacy in glioma treatment. Behenic acid nanoparticles, prepared by the coacervation method, were loaded with the ester prodrug didodecylmethotrexate, which was previously tested in vitro against glioblastoma human primary cultures. Nanoparticle conjugation with an ApoE mimicking chimera peptide was performed to obtain active targeting to the brain. Biodistribution studies in healthy rats assessed the superiority of ApoE-conjugated formulation, which was tested on an F98/Fischer glioma model. Differences were observed in tumor growth rate (measured by MRI) between control and treated rats. In vitro tests on F98 cultured cells assessed their susceptibility to treatment, with consequent apoptosis, and allowed us to explain the apoptosis observed in glioma models.

The Gluten-Free, Casein-Free Diet in Autism: Results of a Preliminary Double Blind Clinical Trial

ERIC Educational Resources Information Center

Elder, Jennifer Harrison; Shankar, Meena; Shuster, Jonathan; Theriaque, Douglas; Burns, Sylvia; Sherrill, Lindsay

2006-01-01

This study tested the efficacy of a gluten-free and casein-free (GFCF) diet in treating autism using a randomized, double blind repeated measures crossover design. The sample included 15 children aged 2-16 years with autism spectrum disorder. Data on autistic symptoms and urinary peptide levels were collected in the subjects' homes over the 12…

Preliminary Investigation of the Sources of Self-Efficacy Among Teachers of Students with Autism.

PubMed

Ruble, Lisa A; Usher, Ellen L; McGrew, John H

2011-06-01

Teacher self-efficacy refers to the beliefs teachers hold regarding their capability to bring about desired instructional outcomes and may be helpful for understanding and addressing critical issues such as teacher attrition and teacher use of research-supported practices. Educating students with autism likely presents teachers with some of the most significant instructional challenges. The self-efficacy of 35 special education teachers of students with autism between the ages of 3 to 9 years was evaluated. Teachers completed rating scales that represented self-efficacy and aspects of the following 3 of Bandura's 4 sources of self-efficacy: (1) sense of mastery, (2) social persuasions, and (3) physiological/affective states. Significant associations were observed between physiological/affective states and self-efficacy, but no associations were observed for the other sources.

Telehealth Problem-Solving Therapy for Depressed Low-Income Homebound Older Adults: Acceptance and Preliminary Efficacy

PubMed Central

Choi, Namkee G.; Hegel, Mark T.; Nathan Marti, C.; Mary Lynn Marinucci, M.S.S.W.; Leslie Sirrianni, M.S.S.W.; Bruce, Martha L.

2012-01-01

Objective To evaluate the acceptance and preliminary efficacy of in-home telehealth delivery of problem-solving therapy (tele-PST) among depressed low-income homebound older adults in a pilot randomized control trial (RCT) designed to test its feasibility and preliminary efficacy. Methods 121 homebound individuals who were age 50+ and scored 15+ on the 24-item Hamilton Rating Scale for Depression (HAMD) participated in the 3-arm RCT, comparing tele-PST to in-person PST and telephone support calls. Six sessions of the PST-PC (primary care) were conducted for the PST participants. For tele-PST, second through sixth sessions were conducted via Skype video call. Acceptance of tele-PST or in-person PST was measured with the 11-item, 7-point scale modified Treatment Evaluation Inventory (TEI). Mixed-effect regression analysis was used to examine the effects of treatment group, time, and the interaction term between treatment group and time on the HAMD scores. Results The TEI score was slightly higher among tele-PST participants than among in-person PST participants. The HAMD scores of tele-PST participants and in-person PST participants at 12-week follow-up were significantly lower than the HAMD scores of telephone support call participants, and the treatment effects were maintained at 24-week follow-up. The HAMD scores of tele-PST participants did not differ from those of in-person PST participants. Conclusions Despite their initial skepticism, almost all participants had extremely positive attitudes toward tele-PST at 12-week follow-up. Tele-PST also appears to be an efficacious treatment modality for depressed homebound older adults and to have significant potential to facilitate their access to treatment. PMID:23567376

Advances of high intensity focused ultrasound (HIFU) for pancreatic cancer.

PubMed

Xiaoping, Li; Leizhen, Zheng

2013-11-01

High intensity focused ultrasound (HIFU) is a novel therapeutic modality. Several preclinical and clinical studies have investigated the safety and efficacy of HIFU for treating solid tumours, including pancreatic cancer. Preliminary studies suggest that HIFU may be useful for the palliative therapy of cancer-related pain in patients with unresectable pancreatic cancer. This review provides a brief overview of HIFU, describes current clinical applications of HIFU for pancreatic cancer, and discusses future applications and challenges.

A continuous glucose monitoring and problem-solving intervention to change physical activity behavior in women with type 2 diabetes: a pilot study.

PubMed

Allen, Nancy; Whittemore, Robin; Melkus, Gail

2011-11-01

Diabetes technology has the potential to provide useful data for theory-based behavioral counseling. The aims of this study are to evaluate the feasibility, acceptability, and preliminary efficacy of a continuous glucose monitoring and problem-solving counseling intervention to change physical activity (PA) behavior in women with type 2 diabetes. Women (n=29) with type 2 diabetes were randomly assigned to one of two treatment conditions: continuous glucose counseling and problem-solving skills or continuous glucose monitoring counseling and general diabetes education. Feasibility data were obtained on intervention dose, implementation, and satisfaction. Preliminary efficacy data were collected at baseline and 12 weeks on the following measures: PA amount and intensity, diet, problem-solving skills, self-efficacy for PA, depression, hemogoloin A1c, weight, and blood pressure. Demographic and implementation variables were described using frequency distributions and summary statistics. Satisfaction data were analyzed using Wilcoxon rank. Differences between groups were analyzed using linear mixed-modeling. Women were mostly white/non-Latina with a mean age of 53 years, a 6.5-year history of diabetes, and suboptimal glycemic control. Continuous glucose monitoring plus problem-solving group participants had significantly greater problem-solving skills and had greater, although not statistically significant, dietary adherence, moderate activity minutes, weight loss, and higher intervention satisfaction pre- to post-intervention than did participants in the continuous glucose monitoring plus education group. A continuous glucose monitoring plus problem-solving intervention was feasible and acceptable, and participants had greater problem-solving skills than continuous glucose monitoring plus education group participants.

Preliminary examination of the efficacy and safety of a standardized chamomile extract for chronic primary insomnia: a randomized placebo-controlled pilot study.

PubMed

Zick, Suzanna M; Wright, Benjamin D; Sen, Ananda; Arnedt, J Todd

2011-09-22

Despite being the most commonly used herbal for sleep disorders, chamomile's (Matricaria recutita) efficacy and safety for treating chronic primary insomnia is unknown. We examined the preliminary efficacy and safety of chamomile for improving subjective sleep and daytime symptoms in patients with chronic insomnia. We performed a randomized, double-blind, placebo-controlled pilot trial in 34 patients aged 18-65 years with DSM-IV primary insomnia for ≥ 6-months. Patients were randomized to 270 mg of chamomile twice daily or placebo for 28-days. The primary outcomes were sleep diary measures. Secondary outcomes included daytime symptoms, safety assessments, and effect size of these measures. There were no significant differences between groups in changes in sleep diary measures, including total sleep time (TST), sleep efficiency, sleep latency, wake after sleep onset (WASO), sleep quality, and number of awakenings. Chamomile did show modest advantage on daytime functioning, although these did not reach statistical significance. Effect sizes were generally small to moderate (Cohen's d ≤ 0.20 to < 0.60) with sleep latency, night time awakenings, and Fatigue Severity Scale (FSS), having moderate effect sizes in favor of chamomile. However, TST demonstrated a moderate effect size in favor of placebo. There were no differences in adverse events reported by the chamomile group compared to placebo. Chamomile could provide modest benefits of daytime functioning and mixed benefits on sleep diary measures relative to placebo in adults with chronic primary insomnia. However, further studies in select insomnia patients would be needed to investigate these conclusions.

Preliminary efficacy and tolerability of chemohormonal therapy in metastatic hormone-naïve prostate cancer: The first real-life experience in Asia.

PubMed

Poon, Darren M C; Chan, Tim; Chan, Kuen; Chan, Michelle; Lee, Eric K C; Law, Kitty; Lam, Daisy

2018-04-16

A substantial survival benefit with chemohormonal therapy has been proven by the CHAARTED and STAMPEDE studies, and this clinical approach has emerged as the standard of care for patients with metastatic hormone-naïve prostate cancer (mHSPC). However, because its clinical efficacy and tolerability in Asian patients remains uncertain, this study aims to evaluate preliminary results of its use in Hong Kong. The clinical records of mHSPC patients treated with chemohormonal therapy from all six public oncology centers in Hong Kong between January 2015 and July 2016 were reviewed. Time to castration-resistant prostate cancer (CRPC), treatment-related complications, prostate-specific antigen (PSA) response and the time to PSA nadir were assessed. A total of 32 patients (median age, 66 years) were treated with chemohormonal therapy in the review period. After median follow-up time of 11.4 months, the median time to CRPC and time to PSA nadir were 19.5 months and 7 months, respectively. PSA response (>50% drop in PSA level from baseline) was achieved in all patients and the median maximal PSA response was 99.6%. The rates of grade 3 or 4 febrile neutropenia, neutropenia and anemia were 12.5%, 40.6% and 3.1%, respectively. Early efficacy with chemohormonal therapy in Asian mHSPC patients was comparable to the pivotal study and biochemical response is promising. The high frequency of hematologic toxicities in Asian patients highlights the importance of proper patient selection and pre-emptive use of granulocyte colony-stimulating factor. © 2018 The Authors. Asia-Pacific Journal of Clinical Oncology Published by John Wiley & Sons Australia, Ltd.

[Purification of waste water from olive-oil pressing plants using hydrophytes. Preliminary study on the use of Eichornia crassipes].

PubMed

Ferrara, L; Forgione, P; Schettino, O; Rullo, V

1989-04-01

The use of Eichornia crassipes has been tested in order to depurate the waste water from olive oil factories. The control of some parameter variations during the treatment, such as COD, total azote, dissolved oxygen and pH, has given encouraging results about the depurative efficacy of employed hydrophytae. Particularly indicative is, in this regard, COD rejection of about 60%.

Small Molecule Inhibitors of Drug Resistant Forms of HIV-1 Integrase | NCI Technology Transfer Center | TTC

Cancer.gov

Researchers at the National Cancer Institute discovered small-molecule compounds containing 1-hydroxy-2-oxo-1,8-naphthyridine moieties whose activity against HIV-1 integrase mutants confer resistance to currently approved INSTIs. Preliminary rodent efficacy, metabolic, and pharmacokinetic studies have been completed by the NCI researchers. The National Cancer Institute seeks partners to commercialize this class of compounds through licensing or co-development.

Preliminary Effectiveness of Surviving the Teens[R] Suicide Prevention and Depression Awareness Program on Adolescents' Suicidality and Self-Efficacy in Performing Help-Seeking Behaviors

ERIC Educational Resources Information Center

King, Keith A.; Strunk, Catherine M.; Sorter, Michael T.

2011-01-01

Background: Suicide ranks as the third leading cause of death among youth aged 15-24 years. Schools provide ideal opportunities for suicide prevention efforts. However, research is needed to identify programs that effectively impact youth suicidal ideation and behavior. This study examined the immediate and 3-month effect of Surviving the Teens[R]…

Preliminary Study of the Autism Self-Efficacy Scale for Teachers (ASSET)

PubMed Central

Ruble, Lisa A.; Toland, Michael D.; Birdwhistell, Jessica L.; McGrew, John H.; Usher, Ellen L.

2013-01-01

The purpose of the current study was to evaluate a new measure, the Autism Self-Efficacy Scale for Teachers (ASSET) for its dimensionality, internal consistency, and construct validity derived in a sample of special education teachers (N = 44) of students with autism. Results indicate that all items reflect one dominant factor, teachers’ responses to items were internally consistent within the sample, and compared to a 100-point scale, a 6-point response scale is adequate. ASSET scores were found to be negatively correlated with scores on two subscale measures of teacher stress (i.e., self-doubt/need for support and disruption of the teaching process) but uncorrelated with teacher burnout scores. The ASSET is a promising tool that requires replication with larger samples. PMID:23976899

The relationship between family functioning and caregiving appraisal of dementia family caregivers: caregiving self-efficacy as a mediator.

PubMed

Liu, Hsin-Yi; Huang, Lian-Hua

2018-04-01

The aim of this study was to explore caregiving self-efficacy as a mediator for the association between family functioning and caregiving appraisal of dementia family caregivers in Taiwan. This study adopted a cross-sectional correlational design. Purposive sampling was used to recruit 115 dyads of dementia patients and family caregivers from the outpatient neurological clinics of two hospitals in northern Taiwan. Data were gathered through interviews with a structured questionnaire, which included demographic characteristics for caregivers and patients, family functioning, caregiving self-efficacy, as well as positive and negative aspects of caregiving appraisal. Family functioning, patients' activities of daily living score, Neuropsychiatric Inventory caregiver distress, and three domains of self-efficacy were significantly associated with caregiver burden. Hierarchical multiple regression analyses indicated that self-efficacy for obtaining respite (SE-OR) significantly explained 20.5% of the variance in caregiver esteem. Caregiver perceived worsened health status, family functioning, and SE-OR significantly explained 59% of the variance in caregiver burden. The mediation test only supported the partially mediating role of SE-OR on the relationship between family functioning and caregiver burden, while the mediating effect of self-efficacy for responding to disruptive behaviours and controlling upsetting thoughts were insignificant. Our findings provided preliminary evidence for health professionals recommending that future studies should assess the family dynamic and health problems of caregivers, and develop appropriate family-centred interventions that focus on strengthening interfamily support and respite services to alleviate caregiver burden.

The Impact of the Design Process on Student Self-Efficacy and Content Knowledge

NASA Astrophysics Data System (ADS)

Gess, Ashley J. H.

The United States of America needs STEM trained workers, STEM faculty and STEM professionals to improve its technical and professional workforce in order to maintain leadership in a global economy. However, American students are not opting to remain in a STEM course of study, and this is especially so for women and minorities. Of the students who pursue postsecondary education, the majority of movement away from STEM majors occurs in the first two years. Thus, educators are concerned with investigating factors that may influence students' persistence and success when in a STEM track of learning. To that end, this quasi-experimental mixed-method study was concerned with investigating the effects of participation in the design process on student self-efficacy and content knowledge gains in an undergraduate anatomy and physiology laboratory. Over fifty students participated in a design task that paralleled the topic being studied in a given semester and were given efficacy surveys along with lab practicums. Qualitative efficacy data, quantitative efficacy data and quantitative practicum results were analyzed and triangulated to produce a meta-inference as to the effect of participation in the design project had on student learning. Preliminary results indicate that the design process makes statistically significant impacts on both self-efficacy and content knowledge in the given context. The author follows with a discussion of the impact of design-based learning in the undergraduate biology classroom and implications for further research are considered.

The Potential Efficacy of Psychological First Aid on Self-Reported Anxiety and Mood: A Pilot Study.

PubMed

Everly, George S; Lating, Jeffrey M; Sherman, Martin F; Goncher, Ian

2016-03-01

The authors explored the efficacy of a randomized controlled trial to assess the potential benefits of psychological first aid (PFA) compared with a social acknowledgement condition in a sample of 42 participants who spoke about a stressful life event. Demographics and standardized questionnaires, including the state version of the State Trait Anxiety Inventory Scale and the Brief Profile of Mood States, assessed anxiety and mood state. Those in the PFA group evidenced significantly lower anxiety scores at 30-minute postdisclosure than at baseline and, although not significant, showed lowered distressed mood compared with baseline at 30-minute postdisclosure. Those in the social acknowledgment condition evidenced increases in anxiety and distressed mood scores, albeit not significantly, at 30 minutes post disclosure compared with their baseline scores. These results provide preliminary empirical evidence for the efficacy of PFA, and implications for intervention and additional assessment are suggested.

Association of Depressive Symptoms with Lapses in Antiretroviral Medication Adherence Among People Living with HIV: A Test of an Indirect Pathway.

PubMed

Babowitch, Jacklyn D; Sheinfil, Alan Z; Woolf-King, Sarah E; Vanable, Peter A; Sweeney, Shannon M

2018-03-23

Viral suppression, a critical component of HIV care, is more likely when individuals initiate antiretroviral therapy (ART) early in disease progression and maintain optimal levels of adherence to ART regimens. Although several studies have documented the negative association of depressive symptoms with ART adherence, less is known about how depressed mood relates to intentional versus unintentional lapses in adherence as well as the mechanisms underlying this association. The purpose of the current study was to examine the association of depressive symptoms with ART adherence, assessed as a multidimensional construct. Secondarily, this study conducted preliminary indirect path models to determine if medication self-efficacy could explain the depressed mood-adherence relationship. Depressive symptoms were not associated with 95% ART taken, self-reported viral load, deliberate adjustments to ART regimens or skipped ART doses. However, the indirect association of depressive symptoms via decrements in medication self-efficacy was significant for 95% ART taken, self-reported viral load and skipped ART doses, but not deliberate changes to ART regimens. In this sample of HIV-positive outpatients, there is evidence to support medication self-efficacy as a potential mechanism underlying the association between depressive symptoms and ART adherence. Additional longitudinal studies are needed to formally examine medication taking self-efficacy as a mediator.

Brief Self-Efficacy Scales for use in Weight-Loss Trials: Preliminary Evidence of Validity

PubMed Central

Wilson, Kathryn E.; Harden, Samantha M.; Almeida, Fabio A.; You, Wen; Hill, Jennie L.; Goessl, Cody; Estabrooks, Paul A.

2015-01-01

Self-efficacy is a commonly included cognitive variable in weight-loss trials, but there is little uniformity in its measurement. Weight-loss trials frequently focus on physical activity (PA) and eating behavior, as well as weight loss, but no survey is available that offers reliable measurement of self-efficacy as it relates to each of these targeted outcomes. The purpose of this study was to test the psychometric properties of brief, pragmatic self-efficacy scales specific to PA, healthful eating and weight-loss (4 items each). An adult sample (n=1790) from 28 worksites enrolled in a worksite weight-loss program completed the self-efficacy scale, as well as measures of PA, dietary fat intake, and weight, at baseline, 6-, and 12-months. The hypothesized factor structure was tested through confirmatory factor analysis, which supported the expected factor structure for three latent self-efficacy factors, specific to PA, healthful eating, and weight-loss. Measurement equivalence/invariance between relevant demographic groups, and over time was also supported. Parallel growth processes in self-efficacy factors and outcomes (PA, fat intake, and weight) support the predictive validity of score interpretations. Overall, this initial series of psychometric analyses supports the interpretation that scores on these scales reflect self-efficacy for PA, healthful eating, and weight-loss. The use of this instrument in large-scale weight-loss trials is encouraged. PMID:26619093

Preliminary Investigation of the Sources of Self-Efficacy Among Teachers of Students with Autism

PubMed Central

Ruble, Lisa A.; Usher, Ellen L.; McGrew, John H.

2011-01-01

Teacher self-efficacy refers to the beliefs teachers hold regarding their capability to bring about desired instructional outcomes and may be helpful for understanding and addressing critical issues such as teacher attrition and teacher use of research-supported practices. Educating students with autism likely presents teachers with some of the most significant instructional challenges. The self-efficacy of 35 special education teachers of students with autism between the ages of 3 to 9 years was evaluated. Teachers completed rating scales that represented self-efficacy and aspects of the following 3 of Bandura’s 4 sources of self-efficacy: (1) sense of mastery, (2) social persuasions, and (3) physiological/affective states. Significant associations were observed between physiological/affective states and self-efficacy, but no associations were observed for the other sources. PMID:21691453

A review of current issues underlying colon cleansing before colonoscopy

PubMed Central

Hookey, Lawrence C; Vanner, Stephen

2007-01-01

The present review examines four current issues related to the efficacy, patient tolerance and safety of the following bowel cleansing agents: oral sodium phosphate (NaP), polyethylene glycol (PEG) and magnesium citrate (Pico-Salax, Ferring Pharmaceuticals Inc, Canada), an agent recently made available in Canada. MedLine and PubMed databases were systematically searched to identify studies related to the efficacy of altered PEG solutions combined with adjunct treatments; the efficacy, tolerability and safety of Pico-Salax; the association between nephrocalcinosis, and chronic renal failure and oral NaP use; and the role of diet. Although lower volume PEG solutions combined with adjuvant agents were generally associated with better patient tolerance, their efficacy was varied and interpretation of this end point is complicated by study design issues. There are very few reported studies of Pico-Salax, and as a result, there are insufficient data to draw conclusions about the efficacy of this agent. The available data suggest that Pico-Salax may be better tolerated by patients, than oral NaP and PEG solutions. There is a paucity of hemodynamic monitoring data pre- and postadministration, but the available data suggests that this small-volume osmotic agent could cause subclinical contraction of the intravascular space. Recent case reports suggest an association between nephrocalcinosis and oral NaP ingestion, but to date, these reports have been confined to a single centre. Preliminary studies suggest that this is not a widespread problem, but more studies are needed. There are only a few studies examining diet and patient tolerability, but they do suggest that diet may be liberalized with some cleansing regimens to enhance tolerability without decreasing efficacy. The present review highlights current controversies and advances in colon cleansing before colonoscopy, and also identifies areas for further study. PMID:17299615

A low-fluence 1064-nm Q-switched neodymium-doped yttrium aluminium garnet laser for the treatment of café-au-lait macules.

PubMed

Kim, Hyeong-Rae; Ha, Jeong-Min; Park, Min-Soo; Lee, Young; Seo, Young-Joon; Kim, Chang-Deok; Lee, Jeung-Hoon; Im, Myung

2015-09-01

Café-au-lait macules (CALMs) are a common pigmentary disorder. Although a variety of laser modalities have been used to treat CALMs, their efficacies vary and dyspigmentation may develop. We evaluated the clinical efficacy and safety of a low-fluence 1064-nm Q-switched neodymium-doped yttrium aluminium garnet (Nd:YAG) laser for the treatment of CALMs. In a preliminary investigation, 6 patients underwent a split-lesion comparative study with 532- and 1064-nm Q-switched Nd:YAG laser treatment. In total, 32 patients with 39 CALMs were enrolled in a subsequent prospective trial to evaluate the treatment with a low-fluence 1064-nm Q-switched Nd:YAG laser. In the preliminary study, the 1064-nm treatment group had a more favorable response and a shorter recovery time. In a subsequent prospective trial of a 1064-nm laser, 74.4% of the lesions showed a clinical response with clearance of ≥50.0%. The treatment regimen was well tolerated; 15.4% of patients experienced adverse events. The study participants were followed for 6 months, and there were no relevant treatment controls in the prospective trial group. Low-fluence 1064-nm Q-switched Nd:YAG laser therapy afforded good clinical improvement for treating CALMs. Copyright © 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

A Preliminary Study on the Efficacy of a Community-Based Physical Activity Intervention on Physical Function-Related Risk Factors for Falls Among Breast Cancer Survivors.

PubMed

Lee, C Ellen; Warden, Stuart J; Szuck, Beth; Lau, Y K James

2016-08-01

The aim of this study was to examine the effects of a 6-week community-based physical activity (PA) intervention on physical function-related risk factors for falls among 56 breast cancer survivors (BCS) who had completed treatments. This was a single-group longitudinal study. The multimodal PA intervention included aerobic, strengthening, and balance components. Physical function outcomes based on the 4-meter walk, chair stand, one-leg stance, tandem walk, and dynamic muscular endurance tests were assessed at 6-week pre-intervention (T1), baseline (T2), and post-intervention (T3). T1 to T2 and T2 to T3 were the control and intervention periods, respectively. All outcomes, except the tandem walk test, significantly improved after the intervention period (P < 0.05), with no change detected after the control period (P > 0.05). Based on the falls risk criterion in the one-leg stance test, the proportion at risk for falls was significantly lower after the intervention period (P = 0.04), but not after the control period. A community-based multimodal PA intervention for BCS may be efficacious in improving physical function-related risk factors for falls, and lowering the proportion of BCS at risk for falls based on specific physical function-related falls criteria. Further larger trials are needed to confirm these preliminary findings.

Self-regulation workshop and Occupational Performance Coaching with teachers: A pilot study.

PubMed

Hui, Caroline; Snider, Laurie; Couture, Mélanie

2016-04-01

Teachers' occupational role and performance can be undermined when working with students with disruptive classroom behaviours. This pilot study aimed to explore the impact of school-based occupational therapy intervention on teachers' classroom management self-efficacy and perceived performance/satisfaction in their management of students with disruptive behaviours. This pilot study used a multiple-case replication study design. A cohort of regular classroom elementary school teachers (n = 11) participated in a 1-day workshop on sensorimotor strategies for supporting student self-regulation followed by eight individual sessions of Occupational Performance Coaching (OPC). Measurement tools were the Canadian Occupational Performance Measure, Goal Attainment Scaling (GAS), and Teachers' Self-Efficacy Scale-Classroom Management. Improvement in teachers' perception of performance, satisfaction, and classroom management was seen. GAS showed clinically significant improvement. Improvements were sustained at 7 weeks follow-up. Preliminary results support the use of sensorimotor education combined with OPC to enable teachers' occupational performance. © CAOT 2016.

Designing Studies That Would Address the Multilayered Nature of Health Care

PubMed Central

Pennell, Michael; Rhoda, Dale; Hade, Erinn M.; Paskett, Electra D.

2010-01-01

We review design and analytic methods available for multilevel interventions in cancer research with particular attention to study design, sample size requirements, and potential to provide statistical evidence for causal inference. The most appropriate methods will depend on the stage of development of the research and whether randomization is possible. Early on, fractional factorial designs may be used to screen intervention components, particularly when randomization of individuals is possible. Quasi-experimental designs, including time-series and multiple baseline designs, can be useful once the intervention is designed because they require few sites and can provide the preliminary evidence to plan efficacy studies. In efficacy and effectiveness studies, group-randomized trials are preferred when randomization is possible and regression discontinuity designs are preferred otherwise if assignment based on a quantitative score is possible. Quasi-experimental designs may be used, especially when combined with recent developments in analytic methods to reduce bias in effect estimates. PMID:20386057

A quantitative approach to assessing the efficacy of occupant protection programs: A case study from Montana.

PubMed

Manlove, Kezia; Stanley, Laura; Peck, Alyssa

2015-10-01

Quantitative evaluation of vehicle occupant protection programs is critical for ensuring efficient government resource allocation, but few methods exist for conducting evaluation across multiple programs simultaneously. Here we present an analysis of occupant protection efficacy in the state of Montana. This approach relies on seat belt compliance rates as measured by the National Occupant Protection Usage Survey (NOPUS). A hierarchical logistic regression model is used to estimate the impacts of four Montana Department of Transportation (MDT)-funded occupant protection programs used in the state of Montana, following adjustment for a suite of potential confounders. Activity from two programs, Buckle Up coalitions and media campaigns, are associated with increased seat belt use in Montana, whereas the impact of another program, Selective Traffic Enforcement, is potentially masked by other program activity. A final program, Driver's Education, is not associated with any shift in seat belt use. This method allows for a preliminary quantitative estimation of program impacts without requiring states to obtain any new seat belt use data. This approach provides states a preliminary look at program impacts, and a means for carefully planning future program allocation and investigation. Copyright © 2015 Elsevier Ltd. All rights reserved.

A technical report on video-assisted thoracoscopy in thoracic spinal surgery. Preliminary description.

PubMed

Regan, J J; Mack, M J; Picetti, G D

1995-04-01

This report is a preliminary description of the efficacy of video-assisted thoracoscopic surgery in thoracic spinal procedures that otherwise require open thoracotomy. This report sought to describe the efficacy of video-assisted thoracoscopic surgery in thoracic spinal procedures that otherwise require open thoracotomy. In a landmark study that compared video-assisted thoracoscopic surgery for peripheral lung lesions with thoracotomy, video-assisted thoracoscopic surgery reduced postoperative pain, improved early shoulder girdle function, and shortened hospital stay. Video-assisted thoracoscopic surgery was performed in 12 thoracic spinal patients (herniated nucleus pulposus, infection, tumor, or spinal deformity) and is described in detail in this report. Video-assisted thoracoscopic surgery in thoracic spinal surgery resulted in little postoperative pain, short intensive care unit and hospital stays, and little or no morbidity. In the short follow-up period, there was no post-thoracotomy pain syndrome nor neurologic sequelae in these patients. Operative time decreased dramatically as experience was gained with the procedure. Given consistently improving surgical skills, a number of thoracic spinal procedures using video-assisted thoracoscopic surgery, including thoracic discectomy, internal rib thoracoplasty, anterior osteotomy, corpectomy, and fusion, can be performed safely with no additional surgical time or risk to the patient.

Efficacy of a short-term yoga-based lifestyle intervention in reducing stress and inflammation: preliminary results.

PubMed

Yadav, Raj Kumar; Magan, Dipti; Mehta, Nalin; Sharma, Ratna; Mahapatra, Sushil Chandra

2012-07-01

Previously it was shown that a brief yoga-based lifestyle intervention was efficacious in reducing oxidative stress and risk of chronic diseases even in a short duration. The objective of this study was to assess the efficacy of this intervention in reducing stress and inflammation in patients with chronic inflammatory diseases. This study reports preliminary results from a nonrandomized prospective ongoing study with pre-post design. The study was conducted at the Integral Health Clinic, an outpatient facility conducting these yoga-based lifestyle intervention programs for prevention and management of chronic diseases. Patients with chronic inflammatory diseases and overweight/obese subjects were included while physically challenged, and those on other interventions were excluded from the study. A pretested intervention program included asanas (postures), pranayama (breathing exercises), stress management, group discussions, lectures, and individualized advice. There was a reduction in stress (plasma cortisol and β-endorphin) and inflammation (interleukin [IL]-6 and tumor necrosis factor [TNF]-α) at day 0 versus day 10. Eighty-six (86) patients (44 female, 42 male, 40.07 ± 13.91 years) attended this program. Overall, the mean level of cortisol decreased from baseline to day 10 (149.95 ± 46.07, 129.07 ± 33.30 ng/mL; p=0.001) while β-endorphins increased from baseline to day 10 (3.53 ± 0.88, 4.06 ± 0.79 ng/mL; p=0.024). Also, there was reduction from baseline to day 10 in mean levels of IL-6 (2.16 ± 0.42, 1.94 ± 0.10 pg/mL, p=0.036) and TNF-α (2.85 ± 0.59, 1.95 ± 0.32 pg/mL, p=0.002). This brief yoga-based lifestyle intervention reduced the markers of stress and inflammation as early as 10 days in patients with chronic diseases; however, complete results of this study will confirm whether this program has utility as complementary and alternative therapy.

Feasibility, Acceptability, and Preliminary Effectiveness of a Peer-Delivered and Technology Supported Self-Management Intervention for Older Adults with Serious Mental Illness.

PubMed

Fortuna, Karen L; DiMilia, Peter R; Lohman, Matthew C; Bruce, Martha L; Zubritsky, Cynthia D; Halaby, Mitch R; Walker, Robert M; Brooks, Jessica M; Bartels, Stephen J

2018-06-01

To assess the feasibility, acceptability, and preliminary effectiveness of a peer-delivered and technology supported integrated medical and psychiatric self-management intervention for older adults with serious mental illness. Ten older adults with serious mental illness (i.e., schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder) and medical comorbidity (i.e., cardiovascular disease, obesity, diabetes, chronic obstructive pulmonary disease, hypertension, and/or high cholesterol) aged 60 years and older received the PeerTECH intervention in their homes. Three certified peer specialists were trained to deliver PeerTECH. Data were collected at baseline, one-month, and three-month. The pilot study demonstrated that a three-month, peer-delivered and technology-supported integrated medical and psychiatric self-management intervention ("PeerTECH") was experienced by peer specialists and participants as feasible and acceptable. PeerTECH was associated with statistically significant improvements in psychiatric self-management. In addition, pre/post, non-statistically significant improvements were observed in self-efficacy for managing chronic health conditions, hope, quality of life, medical self-management skills, and empowerment. This pre/post pilot study demonstrated it is possible to train peers to use technology to deliver an integrated psychiatric and medical self-management intervention in a home-based setting to older adults with serious mental illness with fidelity. These findings provide preliminary evidence that a peer-delivered and technology-supported intervention designed to improve medical and psychiatric self-management is feasible, acceptable, and is potentially associated with improvements in psychiatric self-management, self-efficacy for managing chronic health conditions, hope, quality of life, medical self-management skills, and empowerment with older adults with serious mental illness and chronic health conditions.

Exploring the relationship between preferences for high fat foods and efficacy of the ketogenic and modified Atkins diets among children with seizure disorders.

PubMed

Amari, Adrianna; Turner, Zahava; Rubenstein, James E; Miller, Jonathan R; Kossoff, Eric H

2015-02-01

Previous research has indicated that children with seizures may prefer high fat foods - a preference compatible with ketogenic and modified Atkins dietary therapies. The purpose of this prospective study was to examine the relationship between fat preference and efficacy of therapeutic diets in treating intractable seizures among a pediatric population. Preference for high fat foods was directly assessed in a sample of 30 children prior to commencing either the ketogenic or modified Atkins diet. Seizure control was assessed at 1, 3, 6, and 12 months following diet initiation. Using an intent-to-treat analysis, correlations between fat preference and diet efficacy were examined at each follow-up and across the follow-up period. At individual follow-ups, correlations between fat preference and diet efficacy varied in terms of both strength and significance; however, modest, positive correlations with fat preference were significant when examining high levels of efficacy (100% seizure reduction, ≥90% seizure reduction) across a 1-year follow-up period. These findings provide preliminary evidence that fat preference, when directly assessed, may be a useful predictor of treatment efficacy for the ketogenic and modified Atkins diets; however, further research is necessary. Copyright © 2014 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

Comparison of plants used for skin and stomach problems in Trinidad and Tobago with Asian ethnomedicine.

PubMed

Lans, Cheryl

2007-01-05

This paper provides a preliminary evaluation of fifty-eight ethnomedicinal plants used in Trinidad and Tobago for skin problems, stomach problems, pain and internal parasites for safety and possible efficacy. Thirty respondents, ten of whom were male were interviewed from September 1996 to September 2000 on medicinal plant use for health problems. The respondents were obtained by snowball sampling, and were found in thirteen different sites, 12 in Trinidad and one in Tobago. The uses are compared to those current in Asia. Bambusa vulgaris, Bidens alba, Jatropha curcas, Neurolaena lobata, Peperomia rotundifolia and Phyllanthus urinaria are possibly efficacious for stomach problems, pain and internal parasites. Further scientific study of these plants is warranted.

The effect of musical attention control training (MACT) on attention skills of adolescents with neurodevelopmental delays: a pilot study.

PubMed

Pasiali, Varvara; LaGasse, A Blythe; Penn, Saundra L

2014-01-01

Given the effect of musical training on the rate and accuracy of processing auditory information, therapeutic uses of music may potentially have remedial benefits for individuals with neurodevelopmental deficits. However, additional studies are needed to establish efficacy of music therapy interventions for attention skills in children/adolescents with neurodevelopmental disabilities including those with Autism Spectrum Disorders (ASD). To establish feasibility and preliminary efficacy of a group music therapy protocol to improve attention skills (sustained, selective, attentional control/switching) in adolescents diagnosed with autism and/or developmental delays. This single group pretest/posttest study took place in a private school for high functioning adolescents with neurodevelopmental delays. Nine students (4 males, 5 females), ages 13 to 20, participated in the study. Autism severity was assessed using the CARS2-HF and indicated the following distribution for study participants: severe (n = 3), mild (n = 4), or minimal/no (n = 2) symptoms. We assessed feasibility of implementing a 45-min Musical Attention Control Training (MACT) intervention delivered by a board-certified music therapist eight times over 6 weeks in a school setting. We also examined preliminary efficacy of the MACT to improve attention skills using the Test of Everyday Attention for Children (TEA-Ch). Parental consent rate was 100%. All nine participants successfully completed testing measures and 6 weeks of the intervention. Average participation rate was 97%. Data analysis showed positive trends and improvements on measures of attentional control/switching and selective attention. The results showed that the intervention and testing measures were feasible to implement and acceptable to the participants who all completed the protocol. Data analysis demonstrated positive trends indicating that more research on the use of music therapy attention training in high-functioning adolescents with neurodevelopmental disabilities is warranted. © the American Music Therapy Association 2014. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

The staying safe intervention: training people who inject drugs in strategies to avoid injection-related HCV and HIV infection.

PubMed

Mateu-Gelabert, Pedro; Gwadz, Marya Viorst; Guarino, Honoria; Sandoval, Milagros; Cleland, Charles M; Jordan, Ashly; Hagan, Holly; Lune, Howard; Friedman, Samuel R

2014-04-01

This pilot study explores the feasibility and preliminary efficacy of the Staying Safe Intervention, an innovative, strengths-based program to facilitate prevention of infection with the human immunodeficiency virus and with the hepatitis C virus among people who inject drugs (PWID). The authors explored changes in the intervention's two primary endpoints: (a) frequency and amount of drug intake, and (b) frequency of risky injection practices. We also explored changes in hypothesized mediators of intervention efficacy: planning skills, motivation/self-efficacy to inject safely, skills to avoid PWID-associated stigma, social support, drug-related withdrawal symptoms, and injection network size and risk norms. A 1-week, five-session intervention (10 hours total) was evaluated using a pre- versus 3-month posttest design. Fifty-one participants completed pre- and posttest assessments. Participants reported significant reductions in drug intake and injection-related risk behavior. Participants also reported significant increases in planning skills, motivation/self-efficacy, and stigma management strategies, while reducing their exposure to drug withdrawal episodes and risky injection networks.

THE STAYING SAFE INTERVENTION: TRAINING PEOPLE WHO INJECT DRUGS IN STRATEGIES TO AVOID INJECTION-RELATED HCV AND HIV INFECTION

PubMed Central

Mateu-Gelabert, Pedro; Gwadz, Marya Viorst; Guarino, Honoria; Sandoval, Milagros; Cleland, Charles M.; Jordan, Ashly; Hagan, Holly; Lune, Howard; Friedman, Samuel R.

2014-01-01

This pilot study explores the feasibility and preliminary efficacy of the Staying Safe Intervention, an innovative, strengths-based program to facilitate prevention of infection with the human immunodeficiency virus and with the hepatitis C virus among people who inject drugs (PWID). The authors explored changes in the intervention's two primary endpoints: (a) frequency and amount of drug intake, and (b) frequency of risky injection practices. We also explored changes in hypothesized mediators of intervention efficacy: planning skills, motivation/self-efficacy to inject safely, skills to avoid PWID-associated stigma, social support, drug-related withdrawal symptoms, and injection network size and risk norms. A 1-week, five-session intervention (10 hours total) was evaluated using a pre- versus 3-month posttest design. Fifty-one participants completed pre- and posttest assessments. Participants reported significant reductions in drug intake and injection-related risk behavior. Participants also reported significant increases in planning skills, motivation/self-efficacy, and stigma management strategies, while reducing their exposure to drug withdrawal episodes and risky injection networks. PMID:24694328

Investigating Social Support and Network Relationships in Substance Use Disorder Recovery.

PubMed

Stevens, Ed; Jason, Leonard A; Ram, Daphna; Light, John

2015-01-01

Social support and characteristics of one's social network have been shown to be beneficial for abstinence and substance use disorder recovery. The current study explores how specific sources of social support relate to general feelings of social support and abstinence-specific self-efficacy. Data were collected from 31 of 33 individuals residing in 5 recovery houses. Participants were asked to complete social support and social network measures, along with measures assessing abstinence from substance use, abstinence self-efficacy, and involvement in 12-step groups. A significant positive relationship was found between general social support and abstinence-specific self-efficacy. General social support was also significantly associated with the specific social support measures of sense of community and Alcoholics Anonymous (AA) affiliation. Social network size predicted abstinence-related factors such as AA affiliation and perceived stress. These results provide insight regarding individual feelings of social support and abstinence-specific self-efficacy by showing that one's social network-level characteristics are related to one's perceptions of social support. We also found preliminary evidence that individual Oxford Houses influence one's feelings of social support.

Preliminary examination of the efficacy and safety of a standardized chamomile extract for chronic primary insomnia: A randomized placebo-controlled pilot study

PubMed Central

2011-01-01

Background Despite being the most commonly used herbal for sleep disorders, chamomile's (Matricaria recutita) efficacy and safety for treating chronic primary insomnia is unknown. We examined the preliminary efficacy and safety of chamomile for improving subjective sleep and daytime symptoms in patients with chronic insomnia. Methods We performed a randomized, double-blind, placebo-controlled pilot trial in 34 patients aged 18-65 years with DSM-IV primary insomnia for ≥ 6-months. Patients were randomized to 270 mg of chamomile twice daily or placebo for 28-days. The primary outcomes were sleep diary measures. Secondary outcomes included daytime symptoms, safety assessments, and effect size of these measures. Results There were no significant differences between groups in changes in sleep diary measures, including total sleep time (TST), sleep efficiency, sleep latency, wake after sleep onset (WASO), sleep quality, and number of awakenings. Chamomile did show modest advantage on daytime functioning, although these did not reach statistical significance. Effect sizes were generally small to moderate (Cohen's d ≤ 0.20 to < 0.60) with sleep latency, night time awakenings, and Fatigue Severity Scale (FSS), having moderate effect sizes in favor of chamomile. However, TST demonstrated a moderate effect size in favor of placebo. There were no differences in adverse events reported by the chamomile group compared to placebo. Conclusion Chamomile could provide modest benefits of daytime functioning and mixed benefits on sleep diary measures relative to placebo in adults with chronic primary insomnia. However, further studies in select insomnia patients would be needed to investigate these conclusions. Trial Registration ClinicalTrials.gov Identifier NCT01286324 PMID:21939549

Cognitive Factors Affecting Freeze-like Behavior in Humans.

PubMed

Alban, Michael W; Pocknell, Victoria

2017-01-01

Contemporary research on survival-related defensive behaviors has identified physiological markers of freeze/flight/fight. Our research focused on cognitive factors associated with freeze-like behavior in humans. Study 1 tested if an explicit decision to freeze is associated with the psychophysiological state of freezing. Heart rate deceleration occurred when participants chose to freeze. Study 2 varied the efficacy of freezing relative to other defense options and found "freeze" was responsive to variations in the perceived effectiveness of alternative actions. Study 3 tested if individual differences in motivational orientation affect preference for a "freeze" option when the efficacy of options is held constant. A trend in the predicted direction suggested that naturally occurring cognitions led loss-avoiders to select "freeze" more often than reward-seekers. In combination, our attention to the cognitive factors affecting freeze-like behavior in humans represents a preliminary step in addressing an important but neglected research area.

Phytochemicals in Cancer Prevention and Therapy: Truth or Dare?

PubMed Central

Russo, Maria; Spagnuolo, Carmela; Tedesco, Idolo; Russo, Gian Luigi

2010-01-01

A voluminous literature suggests that an increase in consumption of fruit and vegetables is a relatively easy and practical strategy to reduce significantly the incidence of cancer. The beneficial effect is mostly associated with the presence of phytochemicals in the diet. This review focuses on a group of them, namely isothiocyanate, curcumin, genistein, epigallocatechin gallate, lycopene and resveratrol, largely studied as chemopreventive agents and with potential clinical applications. Cellular and animal studies suggest that these molecules induce apoptosis and arrest cell growth by pleiotropic mechanisms. The anticancer efficacy of these compounds may result from their use in monotherapy or in association with chemotherapeutic drugs. This latter approach may represent a new pharmacological strategy against several types of cancers. However, despite the promising results from experimental studies, only a limited number of clinical trials are ongoing to assess the therapeutic efficacy of these molecules. Nevertheless, the preliminary results are promising and raise solid foundations for future investigations. PMID:22069598

Dyadic Efficacy for Smoking Cessation: Preliminary Assessment of a New Instrument

PubMed Central

Rabius, Vance; Carpenter, Matthew J.; Villars, Pamela; Wiatrek, Dawn; McAlister, Alfred

2011-01-01

Introduction: Smoking cessation research has demonstrated a link between social support and quitting, but interventions designed to enhance partner support have often failed. We adapted and tested a measure of dyadic efficacy to assess smokers’ confidence in their abilities to work together as a team with their partners to quit smoking and cope with quitting challenges. Our goal was to establish the psychometric properties of the dyadic efficacy instrument, including its associations with cessation outcomes. Methods: We recruited partnered smokers who called the American Cancer Society's Quitline and administered telephone interviews (N = 634, 59% female, average age = 40 years). Interviews included 8 dyadic efficacy items and a variety of sociodemographic, smoking history, and relationship variables at baseline and quit outcomes at 4 months. Results: Factor analysis of the dyadic efficacy items yielded a 1-factor scale with strong internal consistency (α = .92). Dyadic efficacy was positively associated (p < .0001) with smoking-specific support (r = .51), relationship satisfaction (r = .44), and dyadic coping (r = .54). Dyadic efficacy was not associated with age, gender, race, relationship length, smoking quantity, or previous quit attempts. Respondents with smoking partners who were willing to quit with them had higher dyadic efficacy than those whose smoking partners were not (p < .0001). Higher baseline dyadic efficacy was predictive of 7-day point prevalence quit rates at follow-up (odds ratio = 1.25, 95% CI = 1.02–1.53). Conclusions: With further study, dyadic efficacy may enhance our understanding of the role of partner relationships in smoking cessation. PMID:21324838

Technical aspects of renal denervation in end-stage renal disease patients with challenging anatomy.

PubMed

Spinelli, Alessio; Da Ros, Valerio; Morosetti, Daniele; Onofrio, Silvia D; Rovella, Valentina; Di Daniele, Nicola; Simonetti, Giovanni

2014-01-01

We describe our preliminary experience with percutaneous renal denervation in end-stage renal disease patients with resistant hypertension and challenging anatomy, in terms of the feasibility, safety, and efficacy of this procedure. Four patients with end-stage renal disease patients with resistant hypertension (mean hemodialysis time, 2.3 years) who had been taking at least four antihypertensive medications underwent percutaneous renal denervation. Renal artery eligibility included the absence of prior renal artery interventions, vessel stenosis <70%, or extended calcifications (more than 30% of the vessel circumference). No cut off values of vessel diameter were used. All patients were successfully treated with no intra- or postprocedural complications, and all showed 24-hour ambulatory blood pressure reduction at the 12-month follow-up. Percutaneous renal denervation is a feasible approach for end-stage renal disease patients with resistant hypertension with encouraging short-term preliminary results in terms of procedural efficacy and safety.

The Development and Preliminary Testing of an Instrument for Assessing Fatigue Self-management Outcomes in Patients With Advanced Cancer.

PubMed

Chan, Raymond Javan; Yates, Patsy; McCarthy, Alexandra L

Fatigue is one of the most distressing and commonly experienced symptoms in patients with advanced cancer. Although the self-management (SM) of cancer-related symptoms has received increasing attention, no research instrument assessing fatigue SM outcomes for patients with advanced cancer is available. The aim of this study was to describe the development and preliminary testing of an interviewer-administered instrument for assessing the frequency and perceived levels of effectiveness and self-efficacy associated with fatigue SM behaviors in patients with advanced cancer. The development and testing of the Self-efficacy in Managing Symptoms Scale-Fatigue Subscale for Patients With Advanced Cancer (SMSFS-A) involved a number of procedures: item generation using a comprehensive literature review and semistructured interviews, content validity evaluation using expert panel reviews, and face validity and test-retest reliability evaluation using pilot testing. Initially, 23 items (22 specific behaviors with 1 global item) were generated from the literature review and semistructured interviews. After 2 rounds of expert panel review, the final scale was reduced to 17 items (16 behaviors with 1 global item). Participants in the pilot test (n = 10) confirmed that the questions in this scale were clear and easy to understand. Bland-Altman analysis showed agreement of results over a 1-week interval. The SMSFS-A items were generated using multiple sources. This tool demonstrated preliminary validity and reliability. The SMSFS-A has the potential to be used for clinical and research purposes. Nurses can use this instrument for collecting data to inform the initiation of appropriate fatigue SM support for this population.

Efficacy of citalopram and moclobemide in patients with social phobia: some preliminary findings.

PubMed

Atmaca, Murad; Kuloglu, Murat; Tezcan, Ertan; Unal, Ahmet

2002-12-01

The efficacy of irreversible and reversible monoamine oxidase inhibitors (MAOIs) in the treatment of social phobia (SP) is well established. Recently, selective serotonin reuptake inhibitors (SSRIs) have been used more frequently. In the present study, the efficacy and side-effect profile of citalopram, an SSRI, and moclobemide, the only MAOI used in Turkey, were compared. The 71 patients diagnosed with SP according to DSM-III-R were randomly assigned to two subgroups; citalopram (n = 36) or moclobemide (n = 35). The study was an 8-week, randomized, open-label, rater-blinded, parallel-group trial. All patients were assessed by Hamilton anxiety rating (HAM-A), Liebowitz social anxiety (LSAS), clinical global impression-severity of illness (CGI-SI) and clinical global impression-improvement (CGI-I) scales. There was a similar percentage of responders (citalopram 75%, n = 27 and moclobemide 74.3%, n = 26), with a >50% or greater reduction in LSAS total score and ratings of "very much" or "much improved" on the CGI-I. None of the patients withdrew from the study. The results of the present study suggest that citalopram has shown promising results in patients with SP. Copyright 2002 John Wiley & Sons, Ltd.

Early life trauma: An exploratory study of effects on OXTR and NR3C1 gene expression and nurturing self-efficacy in mothers of infants.

PubMed

Light, Alysson E; Holt-Lunstad, Julianne; Porter, Chris L; Light, Kathleen C

2018-03-24

In animals, adverse early experience alters oxytocinergic and glucocorticoid activity and maternal behavior in adulthood. This preliminary study explored associations among childhood trauma (loss of a parent or sexual abuse in childhood), maternal self-efficacy, and leukocyte gene expression (mRNA) of oxytocin and glucocorticoid receptors (OXTR and NR3C1) in mothers of infants. 62 mothers (20 with early life trauma) with healthy 3-month old infants reported maternal self-efficacy, depression, infant temperament, and overall social support; the effects of early trauma on these measures were assessed. Of these, 35 mothers (14 with early trauma) underwent blood draws after 2 infant feeding times; their OXTR and NR3C1 mRNA was compared to a control group of 25 no-infant women without early trauma, and also was examined for associations with self-efficacy. OXTR mRNA was increased in mothers of infants versus no-infant controls (p < 0.0003), and mothers with greatest prior maternal experience had higher OXTR than those with less experience (0-2 vs. 3+ older children, p < 0.033). Mothers with early trauma and less maternal experience had lower OXTR mRNA than no-trauma mothers (p < 0.029) and lower NR3C1 mRNA than controls (p < 0.004). Mothers with depression also had lower NR3C1 than other mothers (p < 0.003) but did not differ in OXTR. Mothers with early trauma also reported their support network to be less helpful and more upsetting and unpredictable than other mothers (p < 0.035-p < 0.005). Regarding maternal behavior, in mothers with early trauma, helpful support networks increased self-reported nurturing self-efficacy when babies were not fussy but decreased it with fussy babies (p < 0.05). Support was unrelated to self-efficacy in no-trauma mothers. Similarly, among mothers with low OXTR or NR3C1 (-1SD, most having early trauma and lower maternal experience), greater support was associated with lower self-efficacy (p < 0.05), while mothers with high OXTR or NR3C1 (+1SD) tended to have higher self-efficacy with greater support. These preliminary findings need confirmation in a larger sample but suggest that childhood trauma influences maternal behavior and both OXTR and NR3C1 pathways in mothers of infants, and that both depression and prior maternal experience may be other important factors. Effects on maternal behavior appear to require more complex modeling. Copyright © 2018 Elsevier B.V. All rights reserved.

A Pilot Study on Telephone Cognitive Behavioral Therapy for Patients Six-Months Post-Bariatric Surgery

PubMed Central

Cassin, Stephanie E.; Wnuk, Susan; Du, Chau; Jackson, Timothy; Hawa, Raed; Parikh, Sagar V.

2017-01-01

Objective This study aimed to determine the feasibility and preliminary efficacy of a post-operative telephone-based cognitive behavioral therapy intervention (Tele-CBT) in improving eating pathology and psychosocial functioning. Methods Six-month post-operative bariatric surgery patients (n = 19) received six sessions of Tele-CBT. Study outcome variables included binge eating (BES), emotional eating (EES), depressive symptoms (PHQ-9), and anxiety symptoms (GAD-7). Results Retention was 73.7 % post-intervention. Tele-CBT resulted in significant reductions in mean difference scores on BES, EES-Total, EES-Anxiety, EES-Anger, PHQ9, and GAD7. Tele-CBT patients experienced a mean weight loss of 8.62 ± 15.02 kg between 6-months post-surgery (pre-Tele-CBT) and 12-months post-surgery. Conclusions These preliminary results suggest that post-surgery Tele-CBT is feasible and can improve post-surgery symptoms of psychopathology in this uncontrolled study, supporting the need for a randomized controlled trial. PMID:27491293

Platelet lysate mucohadesive formulation to treat oral mucositis in graft versus host disease patients: a new therapeutic approach.

PubMed

Del Fante, Claudia; Perotti, Cesare; Bonferoni, Maria Cristina; Rossi, Silvia; Sandri, Giuseppina; Ferrari, Franca; Scudeller, Luigia; Caramella, Carla Marcella

2011-09-01

Optimal treatment of oral mucositis (OM) due to graft versus host disease (GvHD) is currently not available. Platelet-derived growth factors (PDGFs) have high capability for tissue healing and may play a role in repairing the mucosal barrier. The aim of the present work was to develop a mucoadhesive formulation to administer platelet lysate to oral cavity prolonging contact time of platelet lysate with oral mucosa. The mucoadhesive formulation was characterized for in vitro properties (PDGF-AB concentration, mucoadhesive properties, cytotoxicity, fibroblast proliferation, wound healing). Moreover, a preliminary clinical study on seven GvHD patients with OM refractory to other therapies was conducted, to evaluate feasibility, safety, and efficacy. GVPL (mucoadhesive gel vehicle mixed with platelet lysate)showed good mucoadhesive properties; additionally, it was characterized by good biocompatibility in vitro on fibroblasts and it was able to enhance fibroblast proliferation and wound healing, maintaining the efficacy for up to 14 days following storage at 2-8°C. In vivo, clinical response was good-to-complete in five, fair in one, none in the remaining one. The in vitro results indicate that GVPL has optimal mucoadhesive and healing enhancer properties, maintained over time (up to 14 days); preliminary clinical results suggest that oral application of platelet lysate-loaded mucoadhesive formulation is feasible, safe, well tolerated, and effective. A larger controlled randomized study is needed.

Mind-Body Treatments for the Pain-Fatigue-Sleep Disturbance Symptom Cluster in Persons with Cancer

PubMed Central

Kwekkeboom, Kristine L.; Cherwin, Catherine H.; Lee, Jun W.; Wanta, Britt

2011-01-01

Purpose To synthesize evidence regarding mind-body interventions that have shown efficacy in treating two or more symptoms in the pain-fatigue-sleep disturbance cancer symptom cluster. Design A literature search was conducted using CINAHL, Medline, and PsychInfo databases through March 2009. Methods Studies were categorized based on the type of mind-body intervention (relaxation, imagery / hypnosis, cognitive-behavioral therapy / coping skills training [CBT/CST], meditation, music, and virtual reality), and a preliminary review was conducted with respect to efficacy for pain, fatigue, and sleep disturbance. Mind-body interventions were selected for review if there was evidence of efficacy for at least two of the three symptoms. Forty-three studies, addressing five types of mind-body interventions met criteria and are summarized in this review. Findings Imagery / hypnosis and CBT / CST interventions have produced improvement in all three cancer-related symptoms individually: pain, fatigue, and sleep disturbance. Relaxation has resulted in improvements in pain and sleep disturbance. Meditation interventions have demonstrated beneficial effects on fatigue and sleep disturbance. Music interventions have demonstrated efficacy for pain and fatigue. No trials were found that tested the mind-body interventions specifically for the pain-fatigue-sleep disturbance symptom cluster. Conclusions Efficacy studies are needed to test the impact of relaxation, imagery / hypnosis, CBT / CST, meditation and music interventions in persons with cancer experiencing concurrent pain, fatigue, and sleep disturbance. These mind-body interventions could help patients manage all symptoms in the cluster with a single treatment strategy. PMID:19900778

Culturally Adapted Cognitive Behavioral Guided Self-Help for Binge Eating: A Feasibility Study with Mexican Americans

PubMed Central

Cachelin, Fary M.; Shea, Munyi; Phimphasone, Phoutdavone; Wilson, G. Terence; Thompson, Douglas R.; Striegel, Ruth H.

2014-01-01

Objective was to test feasibility and preliminary efficacy of a culturally adapted cognitive-behavioral self-help program to treat binge eating and related problems in Mexican Americans. Participants were 31 women recruited from the Los Angeles area and diagnosed with binge eating disorder, recurrent binge eating or bulimia nervosa. Participants completed a culturally adapted version of a CBT-based self-help program with 8 guidance sessions over a 3-month period. Treatment efficacy was evaluated in terms of binge eating, psychological functioning, and weight loss. Intent-to-treat analyses revealed 35.5% abstinence from binge eating at post-treatment and 38.7% diagnostic remission. Results indicated significant pre-treatment to post-treatment improvement on distress level, BMI, eating disorder psychopathology, and self-esteem. Satisfaction with the program was high. Findings demonstrate that the program is acceptable, feasible, and efficacious in reducing binge eating and associated symptoms for Mexican American women. Study provides “proof of concept” for implementation of culturally adapted forms of evidence-based programs. PMID:25045955

Efficacy and tolerability of bromelain in patients with chronic rhinosinusitis--a pilot study.

PubMed

Büttner, L; Achilles, N; Böhm, M; Shah-Hosseini, K; Mösges, R

2013-01-01

To evaluate the efficacy, tolerability, and impact on quality of life (QoL) of bromelain tablets (500 FIP) in patients with chronic rhinosinusitis (CRS). In this prospective, open-label observational pilot study, 12 patients suffering from CRS with (CRS+NP) or without (CRS-NP) nasal polyps who had undergone prior sinus surgery were treated with bromelain tablets (500 FIP) for three months. Efficacy was evaluated using symptom scores (Total Symptom Scores: TSS); a Total Rhinoscopy Score (TRS) was also determined. QoL was assessed by using the German, adapted version of the Sinonasal Outcome Test 20 (SNOT-20 GAV). Treatment with bromelain tablets (500 FIP) improved TSS, TRS and SNOT-20 GAV on average. This treatment was found to be more effective, however, for CRS-NP than for CRS+NP. The average intake was six tablets, equivalent to a daily dosage of 3000 FIP. No adverse events were observed. Preliminary results indicate good tolerability, symptom control, and improvement in QoL for the treatment of CRS using bromelain tablets (500 FIP).

A Mindful Approach to Diabetes Self-Management Education and Support for Veterans.

PubMed

DiNardo, Monica; Saba, Shaddy; Greco, Carol M; Broyles, Lauren; Terhorst, Lauren; Chasens, Eileen R; Bair, Brandi; Charron-Prochownik, Denise; Cohen, Susan

2017-12-01

Purpose The purpose of this study is to determine feasibility, satisfaction, and preliminary effects of Mindful Stress Reduction in Diabetes Education (Mind-STRIDE), a mindfulness-based intervention for veterans. Methods The study used a single-group pretest-posttest repeated-measures design. The 90-minute Mind-STRIDE training, adapted from Mindfulness Based Stress Reduction (MBSR), was provided as the final component of a half-day diabetes self-management education class at a Veterans Affairs (VA) outpatient diabetes clinic. Following initial training, participants were asked to practice mindfulness at home for 10 minutes each day during the 3-month study. Study recruitment and retention were calculated as rates. Veteran and diabetes educator satisfaction were assessed by rating scales and open-ended comments. Psychosocial-behavioral and metabolic outcomes were assessed at baseline and 3 months after initial training. Bivariate correlations were performed to describe relationships between mindfulness and other outcome variables. Gain scores and Wilcoxon matched-pair signed rank tests were used to assess pre to post changes; Cohen's d was applied to estimate the magnitude of effects. Results Twenty-eight of 49 eligible veterans (57%) enrolled in the study. Of those, 11 veterans (39%) demonstrated participation in home practice, and 20 veterans (71%) completed the study. Overall, participants and diabetes educators were highly satisfied with the Mind-STRIDE intervention. Significant improvements were found in diabetes distress, diabetes self-efficacy, diabetes self-management behaviors, mindful-describing, and A1C. Conclusion Results suggest feasibility, satisfaction, and positive preliminary effects. Efficacy testing by randomized controlled trial with analysis of covariance structures is warranted.

Acceptability and preliminary efficacy of a tailored online HIV/STI testing intervention for young men who have sex with men: the Get Connected! program.

PubMed

Bauermeister, José A; Pingel, Emily S; Jadwin-Cakmak, Laura; Harper, Gary W; Horvath, Keith; Weiss, Gretchen; Dittus, Patricia

2015-10-01

Southeast Michigan accounts for over 70 % of all HIV/STI cases in the state, with young men who have sex with men (YMSM) between the ages of 13 and 24 encumbering the largest burden in HIV/STI incidence. Using community-based participatory research principles, we developed and pilot tested a web-based, randomized control trial seeking to promote HIV/STI testing ("Get Connected!") among YMSM (N = 130; ages 15-24). Randomized participants completed a baseline assessment and shown a test-locator condition (control) or a tailored, personalized site (treatment). At 30-day follow-up, we found high acceptability among YMSM in both conditions, yet higher credibility of intervention content among YMSM in the treatment group (d = .55). Furthermore, 30 participants reported testing by following, with the majority of these participants (73.3 %; n = 22) completing the treatment condition, a clinically meaningful effect (d = .34) suggesting preliminary efficacy for the intervention. These results demonstrate the potential of the intervention, and suggest that a larger efficacy trial may be warranted.

The Mediating Effect of Self-Efficacy in the Connections between Strength-Based Parenting, Happiness and Psychological Distress in Teens

PubMed Central

Loton, Daniel J.; Waters, Lea E.

2017-01-01

Preliminary studies of strength-based parenting (SBP), a style of parenting that seeks to build strengths knowledge and strengths use in one’s child, have reported benefits such as higher life satisfaction, subjective wellbeing, and positive emotions together with lower stress in children and teens. Two proximal mediators conveying these effects have been identified: teen’s own use of strengths and strength-based coping, along with a small moderating effect of growth mindsets relating to strengths. The current study tests the potential mediating effect of self-efficacy, a sense of agency in life, in the relationship between SBP and mental health (wellbeing and illbeing) in teens. Self efficacy has been linked to wellbeing and strengths processes in past studies and is classed as a basic human need and form of eudaimonic happiness. This study reconfirmed the adaptive benefits of SBP in a large sample of Australian adolescents (N = 11,368; 59% male; Mage = 14.04, SDage = 1.99) sourced from 28 schools. Using structural equation modeling, SBP significantly and directly predicted higher happiness and lower depression, with direct effects falling into the 85th and 95th percentile of meta-analytically derived individual differences effect sizes. In addition, self-efficacy was a significant partial mediator, accounting for 40.0% of the total effect on happiness and 52.7% of the total effect on distress. Self-efficacy was also a full mediator in the case of anxiety, with a strong indirect effect. Results suggest that building strengths in teens can also build self-efficacy, and given the large effect sizes, that SBP is a promising leverage point for increasing teen wellbeing. PMID:29066986

The Mediating Effect of Self-Efficacy in the Connections between Strength-Based Parenting, Happiness and Psychological Distress in Teens.

PubMed

Loton, Daniel J; Waters, Lea E

2017-01-01

Preliminary studies of s trength-based parenting (SBP), a style of parenting that seeks to build strengths knowledge and strengths use in one's child, have reported benefits such as higher life satisfaction, subjective wellbeing, and positive emotions together with lower stress in children and teens. Two proximal mediators conveying these effects have been identified: teen's own use of strengths and strength-based coping, along with a small moderating effect of growth mindsets relating to strengths. The current study tests the potential mediating effect of self-efficacy, a sense of agency in life, in the relationship between SBP and mental health (wellbeing and illbeing) in teens. Self efficacy has been linked to wellbeing and strengths processes in past studies and is classed as a basic human need and form of eudaimonic happiness. This study reconfirmed the adaptive benefits of SBP in a large sample of Australian adolescents ( N = 11,368; 59% male; M age = 14.04, SD age = 1.99) sourced from 28 schools. Using structural equation modeling, SBP significantly and directly predicted higher happiness and lower depression, with direct effects falling into the 85th and 95th percentile of meta-analytically derived individual differences effect sizes. In addition, self-efficacy was a significant partial mediator, accounting for 40.0% of the total effect on happiness and 52.7% of the total effect on distress. Self-efficacy was also a full mediator in the case of anxiety, with a strong indirect effect. Results suggest that building strengths in teens can also build self-efficacy, and given the large effect sizes, that SBP is a promising leverage point for increasing teen wellbeing.

Applying the social cognitive perspective to volunteer intention in China: the mediating roles of self-efficacy and motivation.

PubMed

Wang, Ji-Wei; Wei, Chang-Nian; Harada, Koichi; Minamoto, Keiko; Ueda, Kimiyo; Cui, Hong-Wei; Zhang, Cheng-Gang; Cui, Zhi-Ting; Ueda, Atsushi

2011-06-01

When predicting volunteer intention, much attention is paid to the volunteer organization environment (VOE). Given that self-efficacy and motivation have emerged as important predictors of volunteer intention, we adopted a combination of ideas of Bandura's social cognitive theory and Ajzen's theory of planned behavior integrating VOE, self-efficacy and motivation to examine their effects on volunteer intention and to determine whether self-efficacy and motivation mediate the relationship between VOE and volunteer intention. The subjects of this study consisted of 198 community health volunteers in Shanghai city, China. Exploratory factor analysis was performed to identify the factor structure using standard principal component analysis. Six new factors were revealed, including two VOE factors, relation with organization and support from government; two motivation factors, personal attitude and social recognition; self-efficacy and volunteer intention. The results of a hierarchical regression analysis indicated that relation with organization accounted for 14.8% of the variance in volunteer intention, and support from government failed to add significantly to variance in volunteer intention; self-efficacy and personal attitude motivation partially mediated the effects of relation with organization on volunteer intention; social recognition motivation did not mediate the relationship between relation with organization and volunteer intention; and relation with organization, self-efficacy and personal attitude motivation accounted for 33.7% of the variance in volunteer intention. These results provide support for self-efficacy and personal attitude motivation as mediators and provide preliminary insight into the potential mechanisms for predicting volunteer intention and improving volunteering by integrating VOE, self-efficacy and motivation factors.

A preliminary study of cognitive-behavioral family-based treatment versus parent training for young children with obsessive-compulsive disorder.

PubMed

Rosa-Alcázar, Ana I; Iniesta-Sepúlveda, Marina; Storch, Eric A; Rosa-Alcázar, Ángel; Parada-Navas, José L; Olivares Rodríguez, José

2017-01-15

Cognitive-Behavioral Family-Based Treatment (CBFT) is the standard of care in young children with OCD. Developmental considerations, parent desires, and cost-effective advantages motivate research to explore the relative efficacy of parent-only interventions. The main goal in this study was to test the effectiveness and feasibility of a parent only intervention for OCD in young children, comparing, in a preliminary fashion the relative efficacy of reducing obsessive-compulsive symptoms through two treatment conditions: 1) an individual CBFT for early OCD involving both parents and children, and 2) the family component of the intervention involving only individual Parent Training (PT). Twenty treatment-seeking families from two private outpatient clinics in Spain were alternately assigned to one of the two treatment conditions. Participants had a primary diagnosis of OCD and a mean age of 6.62 years (65% males). Interventions were conducted by the same therapist and the assessments were administered by independent clinicians who were blind to the experimental conditions of the participants. Assessment time-points were pretreatment, posttreatment, and 3-month follow-up (including diagnosis, symptom severity, global functioning, family accommodation, externalizing and internalizing symptoms, and satisfaction measures). The two ways of implementation, involving child and parents (CBFT) or involving only parents (PT), produced clinical improvements and were well-accepted by parents and children. The CBFT condition was superior to the PT condition in reducing externalizing problems. reduced sample size and absence of randomization were the main limitations of this study. these results suggest, in a preliminary manner, that the need to have the child present at session with the clinician could be decreased for some children, as well as the overall feasibility of working only with parents for the implementation of CBT for OCD in very young children. Copyright © 2016 Elsevier B.V. All rights reserved.

A Preliminary Study on the Efficacy of a Community-Based Physical Activity Intervention on Physical Function-Related Risk Factors for Falls among Breast Cancer Survivors

PubMed Central

Lee, C. Ellen; Warden, Stuart J.; Szuck, Beth; Lau, Y.K. James

2015-01-01

Objective The aim of this study was to examine the effects of a 6-week community-based physical activity (PA) intervention on physical function-related risk factors for falls among 56 breast cancer survivors (BCS) who had completed treatments. Design This was a single-group longitudinal study. The multimodal PA intervention included aerobic, strengthening and balance components. Physical function outcomes based on the 4-meter walk, chair stand, one-leg stance, tandem walk, and dynamic muscular endurance tests were assessed at 6-week pre-intervention (T1), baseline (T2), and post-intervention (T3). T1-T2 and T2-T3 were the control and intervention periods, respectively. Results All outcomes, except the tandem walk test, significantly improved after the intervention period (p < 0.05), with no change detected after the control period (p > 0.05). Based on the falls risk criterion in the one-leg stance test, the proportion at risk for falls was significantly lower after the intervention period (p = 0.04), but not after the control period. Conclusions A community-based multimodal PA intervention for BCS may be efficacious in improving physical function-related risk factors for falls, and lowering the proportion of BCS at risk for falls based on specific physical function-related falls criteria. Further larger trials are needed to confirm these preliminary findings. PMID:26829081

Mobile technology-based interventions for adult users of alcohol: A systematic review of the literature.

PubMed

Fowler, Lauren A; Holt, Sidney L; Joshi, Deepti

2016-11-01

Worldwide, 16% of people aged 15 and older engage in harmful use of alcohol. Harmful alcohol use leads to a host of preventable negative social and health consequences. Mobile technology-based interventions provide a particularly promising avenue for the widespread and cost-effective delivery of treatment that is accessible, affordable, individualized, and destigmatized to both alcohol-dependent and nondependent individuals. The present review sought to summarize the current literature on mobile technology-based interventions among adult users of alcohol and determine the efficacy of such interventions. Five databases were searched in December 2015 (Jan. 2004-Dec. 2015). Inclusion criteria were: participants aged 18 or older, interventions delivered through mobile-technology, and outcome measurement of alcohol reduction/cessation. Eight studies met inclusion criteria. The majority of the studies reviewed found positive effects of the intervention, even though the interventions themselves varied in design, length, dosage, and target population, and were pilot or preliminary in nature. Findings from this review highlight the promising, yet preliminary state of research in this area. Studies with adequate power and valid design are necessary to evaluate the potential of mobile technology-based interventions on long-term alcohol behavior outcomes. Furthermore, future research should elucidate what the most effective length of time is for a mobile technology-based intervention, how often individuals should receive messages for maximum benefit, and determine the comparative effectiveness of mobile technology interventions with other efficacious interventions. Copyright © 2016 Elsevier Ltd. All rights reserved.

Endovascular radiofrequency renal denervation in treating refractory arterial hypertension: a preliminary experience.

PubMed

Simonetti, G; Spinelli, A; Gandini, R; Da Ros, V; Gaspari, E; Coco, I; De Francesco, M; Santucci, D; Di Daniele, N; Lauro, R

2012-04-01

This study was done to investigate the efficacy and safety of percutaneous renal denervation with the Symplicity catheter for reducing blood pressure in patients with essential hypertension resistant to medical therapy (systolic blood pressure >160 mmHg despite the use of three or more antihypertensive drugs, including a diuretic). In September 2010, five patients affected by essential hypertension resistant to medical therapy were treated. All patients were studied by computed tomography angiography (CTA) of the renal arteries before the procedure and underwent follow-up at 30 and 60 days with colour Doppler ultrasound (CDUS) with evaluation of resistive index, glomerular filtration rate (GFR), 24-h blood pressure and serum catecholamine concentration. Student's t test was used to assess the effectiveness of the procedure in lowering blood pressure. In treated patients, mean blood pressure at baseline was 171/100 mmHg [standard deviation (SD) ± 8/10]; mean GFR was 91.6 ml/min/1.73 m(2) (SD ± 15). Blood pressure after the procedure was reduced by -18/-5 and -13/-10 mmHg at 30 and 60 days, respectively, with a mean medication reduction of 3.6. No complications occurred during the intra- or periprocedural period or during short-term follow-up. The Symplicity system proved to be efficacious and without serious adverse events in reducing blood pressure and antihypertensive medication use in patients affected by essential hypertension resistant to medical therapy. Although encouraging, our data are preliminary and need to be validated by larger prospective randomised studies.

Feasibility of using high-definition transcranial direct current stimulation (HD-tDCS) to enhance treatment outcomes in persons with aphasia.

PubMed

Richardson, Jessica; Datta, Abhishek; Dmochowski, Jacek; Parra, Lucas C; Fridriksson, Julius

2015-01-01

Transcranial direct current stimulation (tDCS) enhances treatment outcomes post-stroke. Feasibility and tolerability of high-definition (HD) tDCS (a technique that increases current focality and intensity) for consecutive weekdays as an adjuvant to behavioral treatment in a clinical population has not been demonstrated. To determine HD-tDCS feasibility outcomes: 1) ability to implement study as designed, 2) acceptability of repeated HD-tDCS administration to patients, and 3) preliminary efficacy. Eight patients with chronic post-stroke aphasia participated in a randomized crossover trial with two arms: conventional sponge-based (CS) tDCS and HD-tDCS. Computerized anomia treatment was administered for five consecutive days during each treatment arm. Individualized modeling/targeting procedures and an 8-channel HD-tDCS device were developed. CS-tDCS and HD-tDCS were comparable in terms of implementation, acceptability, and outcomes. Naming accuracy and response time improved for both stimulation conditions. Change in accuracy of trained items was numerically higher (but not statistically significant) for HD-tDCS compared to CS-tDCS for most patients. Regarding feasibility, HD-tDCS treatment studies can be implemented when designed similarly to documented CS-tDCS studies. HD-tDCS is likely to be acceptable to patients and clinicians. Preliminary efficacy data suggest that HD-tDCS effects, using only 4 electrodes, are at least comparable to CS-tDCS.

Feasibility of using high-definition transcranial direct current stimulation (HD-tDCS) to enhance treatment outcomes in persons with aphasia

PubMed Central

Richardson, Jessica; Datta, Abhishek; Dmochowski, Jacek; Parra, Lucas C.; Fridriksson, Julius

2018-01-01

BACKGROUND Transcranial direct current stimulation (tDCS) enhances treatment outcomes post-stroke. Feasibility and tolerability of high-definition (HD) tDCS (a technique that increases current focality and intensity) for consecutive weekdays as an adjuvant to behavioral treatment in a clinical population has not been demonstrated. OBJECTIVE To determine HD-tDCS feasibility outcomes: 1) ability to implement study as designed, 2) acceptability of repeated HD-tDCS administration to patients, and 3) preliminary efficacy. METHODS Eight patients with chronic post-stroke aphasia participated in a randomized crossover trial with two arms: conventional sponge-based (CS) tDCS and HD-tDCS. Computerized anomia treatment was administered for five consecutive days during each treatment arm. RESULTS Individualized modeling/targeting procedures and an 8-channel HD-tDCS device were developed. CS-tDCS and HD-tDCS were comparable in terms of implementation, acceptability, and outcomes. Naming accuracy and response time improved for both stimulation conditions. Change in accuracy of trained items was numerically higher (but not statistically significant) for HD-tDCS compared to CS-tDCS for most patients. CONCLUSIONS Regarding feasibility, HD-tDCS treatment studies can be implemented when designed similarly to documented CS-tDCS studies. HD-tDCS is likely to be acceptable to patients and clinicians. Preliminary efficacy data suggest that HD-tDCS effects, using only 4 electrodes, are at least comparable to CS-tDCS. PMID:25547776

[A comparative study on efficacy of glucocorticoids, mineralocorticoids and vasoactive drugs on reversing hearing loss in patients suffering idiopathic sensorineural cochlear hypoacusis. A preliminary clinical trial].

PubMed

Campos-Bañales, Eugenia María; López-Campos, Daniel; de Serdio-Arias, José Luis; Esteban-Rodriguez, J; García-Sáinz, Mar; Muñoz-Cortés, Álvaro; López-Aguado, Daniel

2015-01-01

Sensory neural hearing loss (SNHL) is a disorder characterised by an important deterioration of the auditory function. Re-establishing normal ion homeostasis of the endolymph could be related to hearing recovery and it might be mediated by mineralocorticoids. The main purpose of this preliminary, randomized controlled clinical trial was assessing the recovery of idiopathic sensory neural cochlear hearing loss (SNHL) by comparing the efficacy of 2 types of steroids versus vasodilators. The 3-month intervention involved 70 patients, allocated into 4 different groups: a control with no medication, consisting of 14 patients (8 men and 6 women); a vasodilator group of 21 patients (11 men and 10 women); a glucocorticoid group with 16 patients (10 men and 6 women); and a mineralocorticoid therapy group, consisting of 19 patients (11 men and 8 women). The level of hearing loss and its topography were estimated using Liminal Tone Audiometry (LTA) and Auditory Brainstem Response (ABR). Our research found overall greater efficacy of mineralocorticoids versus glucocorticoids and vasodilators. There was better response in women than in men and it was higher from the left ear, regardless of patient gender. The hearing gain was significantly superior in the mineralocorticoid group, followed by the glucocorticoid group. However, the responses to vasodilators were lesser and of low statistical significance. Copyright © 2014 Elsevier España, S.L.U. and Sociedad Española de Otorrinolaringología y Patología Cérvico-Facial. All rights reserved.

A preliminary investigation on the efficacy of N-acetyl cysteine for mania or hypomania.

PubMed

Magalhães, Pedro Vieira da Silva; Dean, Olivia M; Bush, Ashley I; Copolov, David L; Malhi, Gin S; Kohlmann, Kristy; Jeavons, Susan; Schapkaitz, Ian; Anderson-Hunt, Murray; Berk, Michael

2013-06-01

Oxidative imbalance has emerged as a treatment target in bipolar disorder. As very limited data are available on the clinical use of antioxidants for mania, we report here results from a post hoc and exploratory subgroup analysis of a randomized, placebo-controlled trial of N-acetyl cysteine (NAC). This was a placebo-controlled, randomized, clinical trial assessing the effect of NAC over 24 weeks in mania or hypomania. Symptomatic and functional outcomes were collected over the study period. Fifteen participants were available for this report; two participants in each group failed to complete all assessments. Within-group analyses pointed to an improvement in the NAC group on manic symptoms and worsening in the placebo group on depressive symptoms at endpoint. Although the sample size was small, these results indicated within-group efficacy for this glutathione precursor as compared to placebo. Future trials specifically designed to demonstrate the efficacy of NAC in mania are needed.

Psychedelics as Medicines: An Emerging New Paradigm.

PubMed

Nichols, D E; Johnson, M W; Nichols, C D

2017-02-01

Scientific interest in serotonergic psychedelics (e.g., psilocybin and LSD; 5-HT 2A receptor agonists) has dramatically increased within the last decade. Clinical studies administering psychedelics with psychotherapy have shown preliminary evidence of robust efficacy in treating anxiety and depression, as well as addiction to tobacco and alcohol. Moreover, recent research has suggested that these compounds have potential efficacy against inflammatory diseases through novel mechanisms, with potential advantages over existing antiinflammatory agents. We propose that psychedelics exert therapeutic effects for psychiatric disorders by acutely destabilizing local brain network hubs and global network connectivity via amplification of neuronal avalanches, providing the occasion for brain network "resetting" after the acute effects have resolved. Antiinflammatory effects may hold promise for efficacy in treatment of inflammation-related nonpsychiatric as well as potentially for psychiatric disorders. Serotonergic psychedelics operate through unique mechanisms that show promising effects for a variety of intractable, debilitating, and lethal disorders, and should be rigorously researched. © 2016 American Society for Clinical Pharmacology and Therapeutics.

Cannabidiol monotherapy for treatment-resistant schizophrenia.

PubMed

Zuardi, Antonio Waldo; Hallak, Jaime E C; Dursun, Serdar Murat; Morais, Sílvio L; Sanches, Rafael Faria; Musty, Richard E; Crippa, José Alexandre S

2006-09-01

Cannabidiol (CBD), one of the major products of the marijuana plant, is devoid of marijuana's typical psychological effects. In contrast, potential antipsychotic efficacy has been suggested based on preclinical and clinical data (Zuardi et al., 2002). In this report, we further investigated the efficacy and safety of CBD monotherapy in three patients with treatment-resistant schizophrenia (TRS). This was an in-patient study. All patients were given placebo for the initial 5 days, and from the 6th to 35th day (inclusive) they received CBD (initial oral dose of 40 mg reaching 1280 mg/day). On the 36th day, CBD treatment was discontinued and replaced by placebo for 5 days, which was subsequently switched to olanzapine for over 15 days. Efficacy, tolerability and side effects were assessed. One patient showed mild improvement, but two patients didn't show any improvement during CBD monotherapy. All patients tolerated CBD very well and no side effects were reported. These preliminary data suggest that CBD monotherapy may not be effective for TRS.

Epsiprantel, a new tapeworm remedy. Preliminary efficacy studies in dogs and cats.

PubMed

Manger, B R; Brewer, M D

1989-01-01

The anthelmintic potential of epsiprantel, 2-(cyclohexylcarbonyl)-4-oxo-1,2,3,4,6,7,8,12b-octahydropyrazin [2,1-a] [2]benzapine, was revealed using the tapeworms Dipylidium caninum and Taenia taeniaeformis in the cat, and Taenia pisiformis and T. hydatigena in the dog. Subsequent controlled tests in cats demonstrated oral efficacy of 100% against D. caninum with a single dose of 2.5 mg/kg. Although consistently 100% effective against T. taeniaeformis at 5 mg/kg, a single worm was found in one cat treated at 7.5 mg/kg. In experimental infections of Taenia pisiformis in dogs, 100% activity was achieved from a single oral dose of 1 mg/kg. No adverse reaction or drug-associated toxicity were observed at dose levels used.

The efficacy of IntraFlow intraosseous injection as a primary anesthesia technique.

PubMed

Remmers, Todd; Glickman, Gerald; Spears, Robert; He, Jianing

2008-03-01

The purpose of this study was to compare the efficacy of intraosseous injection and inferior alveolar (IA) nerve block in anesthetizing mandibular posterior teeth with irreversible pulpitis. Thirty human subjects were randomly assigned to receive either intraosseous injection using the IntraFlow system (Pro-Dex Inc, Santa Ana, CA) or IA block as the primary anesthesia method. Pulpal anesthesia was evaluated via electric pulp testing at 4-minute intervals for 20 minutes. Two consecutive 80/80 readings were considered successful pulpal anesthesia. Anesthesia success or failure was recorded and groups compared. Intraosseous injection provided successful anesthesia in 13 of 15 subjects (87%). The IA block provided successful anesthesia in 9 of 15 subjects (60%). Although this difference was not statistically significant (p = 0.2148), the results of this preliminary study indicate that the IntraFlow system can be used as the primary anesthesia method in teeth with irreversible pulpitis to achieve predictable pulpal anesthesia.

Illustrating idiographic methods for translation research: moderation effects, natural clinical experiments, and complex treatment-by-subgroup interactions.

PubMed

Ridenour, Ty A; Wittenborn, Andrea K; Raiff, Bethany R; Benedict, Neal; Kane-Gill, Sandra

2016-03-01

A critical juncture in translation research involves the preliminary studies of intervention tools, provider training programs, policies, and other mechanisms used to leverage knowledge garnered at one translation stage into another stage. Potentially useful for such studies are rigorous techniques for conducting within-subject clinical trials, which have advanced incrementally over the last decade. However, these methods have largely not been utilized within prevention or translation contexts. The purpose of this manuscript is to demonstrate the flexibility, wide applicability, and rigor of idiographic clinical trials for preliminary testing of intervention mechanisms. Specifically demonstrated are novel uses of state-space modeling for testing intervention mechanisms of short-term outcomes, identifying heterogeneity in and moderation of within-person treatment mechanisms, a horizontal line plot to refine sampling design during the course of a clinic-based experimental study, and the need to test a treatment's efficacy as treatment is administered along with (e.g., traditional 12-month outcomes).

Cognitive control training for emotion-related impulsivity.

PubMed

Peckham, Andrew D; Johnson, Sheri L

2018-06-01

Many forms of psychopathology are tied to a heightened tendency to respond impulsively to strong emotions, and this tendency, in turn, is closely tied to problems with cognitive control. The goal of the present study was to test whether a two-week, six-session cognitive control training program is efficacious in reducing emotion-related impulsivity. Participants (N = 52) reporting elevated scores on an emotion-related impulsivity measure completed cognitive control training targeting working memory and response inhibition. A subset of participants were randomized to a waitlist control group. Impulsivity, emotion regulation, and performance on near and far-transfer cognitive tasks were assessed at baseline and after completion of training. Emotion-related impulsivity declined significantly from pre-training to post-training and at two-week follow-up; improvements were not observed in the waitlist control group. A decrease in brooding rumination and an increase in reappraisal were also observed. Participants showed significant improvements on trained versions of the working memory and inhibition tasks as well as improvements on an inhibition transfer task. In sum, these preliminary findings show that cognitive training appears to be well-tolerated for people with significant emotion-driven impulsivity. Results provide preliminary support for the efficacy of cognitive training interventions as a way to reduce emotion-related impulsivity. Copyright © 2018 Elsevier Ltd. All rights reserved.

Pharmacological treatment of comorbid PTSD and substance use disorder: recent progress.

PubMed

Sofuoglu, Mehmet; Rosenheck, Robert; Petrakis, Ismene

2014-02-01

Previous research has identified a strong association between posttraumatic stress disorder (PTSD) and substance use disorder (SUD), necessitating the development of treatments that address both conditions. Some pharmacotherapies are effective for the treatment of PTSD and SUD alone, however; no medications have been proven to be effective for the combination of these conditions. We review the recent advances in pharmacological treatment of comorbid PTSD and SUD. A randomized clinical trial of sertraline, a serotonin reuptake inhibitor (SSRI), did not show overall efficacy for comorbid PTSD and alcohol dependence (AD), although it may have efficacy among light drinkers. Another clinical trial demonstrated the efficacy of both disulfiram and naltrexone for the treatment of AD in individuals with PTSD. A more recent clinical trial suggested that norepinephrine uptake inhibitors may also have efficacy for the treatment of comorbid PTSD and AD. In animal and preliminary human studies, brain norepinephrine and glutamate/GABA have emerged as potential treatment targets for comorbid PTSD and SUD. Noradrenergic medications that are promising for comorbid PTSD and SUD include prazosin, guanfacine, and atomoxetine. Promising glutamate/GABA medications include topiramate, memantine, acamprosate, N-acetylcysteine (NAC), and ketamine. The safety and efficacy of these medications for the treatment of PTSD and SUD need to be tested in controlled clinical trials. Published by Elsevier Ltd.

Euler Technology Assessment program for preliminary aircraft design employing SPLITFLOW code with Cartesian unstructured grid method

NASA Technical Reports Server (NTRS)

Finley, Dennis B.

1995-01-01

This report documents results from the Euler Technology Assessment program. The objective was to evaluate the efficacy of Euler computational fluid dynamics (CFD) codes for use in preliminary aircraft design. Both the accuracy of the predictions and the rapidity of calculations were to be assessed. This portion of the study was conducted by Lockheed Fort Worth Company, using a recently developed in-house Cartesian-grid code called SPLITFLOW. The Cartesian grid technique offers several advantages for this study, including ease of volume grid generation and reduced number of cells compared to other grid schemes. SPLITFLOW also includes grid adaptation of the volume grid during the solution convergence to resolve high-gradient flow regions. This proved beneficial in resolving the large vortical structures in the flow for several configurations examined in the present study. The SPLITFLOW code predictions of the configuration forces and moments are shown to be adequate for preliminary design analysis, including predictions of sideslip effects and the effects of geometry variations at low and high angles of attack. The time required to generate the results from initial surface definition is on the order of several hours, including grid generation, which is compatible with the needs of the design environment.

Baclofen in the management of cannabis dependence syndrome.

PubMed

Imbert, Bruce; Labrune, Nathalie; Lancon, Christophe; Simon, Nicolas

2014-02-01

Cannabis is the most commonly used illicit drug in the world. However, only few studies have shown the efficacy of pharmacologic agents in targeting cannabis withdrawal symptoms or reducing the reinforcing effects of cannabis. Baclofen has been shown to reduce cannabis withdrawal symptoms and the subjective effects of cannabis. We think that the clinical utility of baclofen for cannabis dependence is a reasonable approach. A case report using baclofen is presented and provides preliminary support for the use of baclofen in the management of cannabis dependence.

Randomized Pilot Trial of a Telephone Symptom Management Intervention for Symptomatic Lung Cancer Patients and Their Family Caregivers.

PubMed

Mosher, Catherine E; Winger, Joseph G; Hanna, Nasser; Jalal, Shadia I; Einhorn, Lawrence H; Birdas, Thomas J; Ceppa, DuyKhanh P; Kesler, Kenneth A; Schmitt, Jordan; Kashy, Deborah A; Champion, Victoria L

2016-10-01

Lung cancer is one of the most common cancers affecting both men and women and is associated with high symptom burden and psychological distress. Lung cancer patients' family caregivers also show high rates of distress. However, few interventions have been tested to alleviate significant problems of this population. This study examined the preliminary efficacy of telephone-based symptom management (TSM) for symptomatic lung cancer patients and their family caregivers. Symptomatic lung cancer patients and caregivers (n = 106 dyads) were randomly assigned to four sessions of TSM consisting of cognitive-behavioral and emotion-focused therapy or an education/support condition. Patients completed measures of physical and psychological symptoms, self-efficacy for managing symptoms, and perceived social constraints from the caregiver; caregivers completed measures of psychological symptoms, self-efficacy for helping the patient manage symptoms and managing their own emotions, perceived social constraints from the patient, and caregiving burden. No significant group differences were found for all patient outcomes and caregiver self-efficacy for helping the patient manage symptoms and caregiving burden at two- and six-weeks post-intervention. Small effects in favor of TSM were found regarding caregiver self-efficacy for managing their own emotions and perceived social constraints from the patient. Study outcomes did not significantly change over time in either group. Findings suggest that our brief telephone-based psychosocial intervention is not efficacious for symptomatic lung cancer patients and their family caregivers. Next steps include examining specific intervention components in relation to study outcomes, mechanisms of change, and differing intervention doses and modalities. Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Preliminary study of the safety and efficacy of medium-chain triglycerides for use as an intraocular tamponading agent in minipigs.

PubMed

Soler, Vincent J; Laurent, Camille; Sakr, Frédéric; Regnier, Alain; Tricoire, Cyrielle; Cases, Olivier; Kozyraki, Renata; Douet, Jean-Yves; Pagot-Mathis, Véronique

2017-08-01

To date, only silicone oils and gases have the appropriate characteristics for use in vitreo-retinal surgery as vitreous substitutes with intraocular tamponading properties. This preliminary study evaluated the safety and efficacy of medium-chain triglycerides (MCTs) for use as a tamponading agent in minipigs. In 15 minipigs, 15 right eyes underwent vitrectomies followed by injection of MCT tamponade (day 1). Two groups were defined. In Group A (ten eyes), the surgical procedure before MCT injection included induced rhegmatogenous retinal detachment (RRD), retina flattening, and retinopexy. In Group B (five eyes), MCT was injected without inducing RRD; in these eyes, MCT was removed on day 90. Pigs were sacrificed on day 45 (Group A) or 120 (Group B). Eyes were examined on days 1, 5, 15, and 45 in both groups and on days 90 and 120 in Group B. In Group B only, we performed bilateral electroretinography examinations on days 1 and 120, and histological examinations of MCTs and controlateral eyes were performed after sacrifice. In Group A eyes (n = 9; one eye was non-assessable), on day 45, the retina was flat in seven eyes and two RRD detachments were observed in insufficiently MCT-filled eyes. In Group B, electroretinography showed no significant differences between MCT eyes and controls on days 1 or 120. Histological analyses revealed no signs of retinal toxicity. This study showed that MCT tamponade seems to be effective and safe; however, additional studies are needed before it becomes commonly used as a tamponading agent in humans.

A multicenter, double-blind, safety study of QR-333 for the treatment of symptomatic diabetic peripheral neuropathy. A preliminary report.

PubMed

Valensi, Paul; Le Devehat, Claude; Richard, Jean-Louis; Farez, Cherifo; Khodabandehlou, Taraneh; Rosenbloom, Richard A; LeFante, Carolyn

2005-01-01

QR-333, a topical compound that contains quercetin, a flavonoid with aldose reductase inhibitor effects, ascorbyl palmitate, and vitamin D(3), was formulated to decrease the oxidative stress that contributes to peripheral diabetic neuropathy and thus alleviate its symptoms. This proof-of-principle study assessed the efficacy and safety of QR-333 against placebo in a small cohort of patients with diabetic neuropathy. This randomized, placebo-controlled, double-blind trial included 34 men and women (21-71 years of age) with Type 1 or 2 diabetes and diabetic neuropathy who applied QR-333 or placebo (2:1 ratio), three times daily for 4 weeks, to each foot where symptoms were experienced. Five-point scales were used to determine changes from baseline to endpoint in symptoms and quality of life (efficacy). Safety was assessed through concomitant medications, adverse events, laboratory evaluations, and physical examinations. QR-333 reduced the severity of numbness, jolting pain, and irritation from baseline values. Improvements were also seen in overall and specific quality-of-life measures. QR-333 was well tolerated. Eleven patients in the QR-333 group reported 23 adverse events (all mild or moderate); 4 in the placebo group reported 5 events (all moderate). One patient who applied QR-333 noted a pricking sensation twice, the only adverse event considered possibly related to study treatment. From this preliminary safety study, it appears that QR-333 may safely offer relief of symptoms of diabetic neuropathy and improve quality of life. These findings warrant further investigation of this topical compound.

Dissonance-based eating disorder program reduces cardiac risk: A preliminary trial.

PubMed

Green, Melinda A; Willis, Mary; Fernandez-Kong, Kristen; Reyes, Shuhan; Linkhart, Ruby; Johnson, Molly; Thorne, Tyler; Kroska, Emily; Woodward, Halley; Lindberg, Jessica

2017-04-01

We conducted a randomized, controlled preliminary trial to examine the effect of a dissonance-based eating disorder program on eating disorder symptoms and cardiac risk indices in a community sample of women with subclinical and clinical symptoms (N = 47), examining the efficacy of the program in both the indicated prevention and treatment realms. Eating disorder symptoms, body mass index, and biomarkers of cardiac risk were examined in dissonance and assessment-only control conditions at baseline, postintervention, and 2-month follow-up. Specifically, we assessed mean R wave amplitude, QT interval length, vagal tone (high frequency spectral power of heart rate variability), and sympathetic tone (low/high frequency spectral power ratio) via electocardiography (ECG) at each assessment period. We predicted a statistically significant 2 (condition: control, dissonance) × 3 (time: baseline, postintervention, 2-month follow-up) interaction in the mixed factorial MANOVA results. Results confirmed this hypothesis. Eating disorder symptoms and cardiac risk indices decreased significantly among participants in the dissonance condition at postintervention and 2-month follow-up compared with baseline. Results provide support for the efficacy of a dissonance-based program in the reduction of eating disorder symptoms and cardiac risk indices among women with subclinical and clinical eating disorder symptoms. Findings establish the efficaciousness of this dissonance-based approach in the indicated prevention and treatment realms and establish its efficacy in reducing cardiac risk indicators. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Validation of the Spanish Version of the Mammography-Specific Self-Efficacy Scale.

PubMed

Jerome-D'Emilia, Bonnie; Suplee, Patricia; Akincigil, Ayse

2015-05-01

To consider psychometric estimates of the validity and reliability of the Spanish translation of a mammography-specific self-efficacy scale. A cross-sectional study. Three primarily Hispanic churches and a Hispanic community center in a low-income urban area of New Jersey. 153 low-income Hispanic women aged 40-85 years. The translated scale was administered to participants during a six-month period. Internal consistency, reliability, and construct and predictive validity were assessed. Demographic variables included income and insurance status. Outcome variables included total mammography-specific self-efficacy and having had a mammogram within the past two years. Preliminary evidence of reliability and validity were found, and predictive validity was demonstrated. The health needs of specific populations can be addressed only when research instruments have been appropriately validated and all relevant factors are considered. Diverse groups of low-income women face similar challenges and barriers in their efforts to get screened. Nurses are in an ideal position to help women with preventive care decision making (e.g., screening for breast cancer). Understanding how a woman's level of self-efficacy affects her decision making should be considered when counseling a client.

Using mobile health technology to improve behavioral skill implementation through homework in evidence-based parenting intervention for disruptive behavior disorders in youth: study protocol for intervention development and evaluation.

PubMed

Chacko, Anil; Isham, Andrew; Cleek, Andrew F; McKay, Mary M

2016-01-01

Disruptive behavior disorders (DBDs) (oppositional defiant disorder (ODD) and conduct disorder (CD)) are prevalent, costly, and oftentimes chronic psychiatric disorders of childhood. Evidence-based interventions that focus on assisting parents to utilize effective skills to modify children's problematic behaviors are first-line interventions for the treatment of DBDs. Although efficacious, the effects of these interventions are often attenuated by poor implementation of the skills learned during treatment by parents, often referred to as between-session homework. The multiple family group (MFG) model is an evidence-based, skills-based intervention model for the treatment of DBDs in school-age youth residing in urban, socio-economically disadvantaged communities. While data suggest benefits of MFG on DBD behaviors, similar to other skill-based interventions, the effects of MFG are mitigated by the poor homework implementation, despite considerable efforts to support parents in homework implementation. This paper focuses on the study protocol for the development and preliminary evaluation of a theory-based, smartphone mobile health (mHealth) application (My MFG) to support homework implementation by parents participating in MFG. This paper describes a study design proposal that begins with a theoretical model, uses iterative design processes to develop My MFG to support homework implementation in MFG through a series of pilot studies, and a small-scale pilot randomised controlled trial to determine if the intervention can demonstrate change (preliminary efficacy) of My MFG in outpatient mental health settings in socioeconomically disadvantaged communities. This preliminary study aims to understand the implementation of mHealth methods to improve the effectiveness of evidence-based interventions in routine outpatient mental health care settings for youth with disruptive behavior and their families. Developing methods to augment the benefits of evidence-based interventions, such as MFG, where homework implementation is an essential mediator of treatment benefits is critical to full adoption/implementation of these intervention in routine practice settings and maximizing benefits for youth with DBDs and their families. ClinicalTrials.gov NCT01917838.

The role of self-efficacy in inflammatory bowel disease management: preliminary validation of a disease-specific measure.

PubMed

Keefer, Laurie; Kiebles, Jennifer L; Taft, Tiffany H

2011-02-01

Inflammatory bowel diseases (IBDs) require self-management skills that may be influenced by self-efficacy (SE). Self-efficacy represents an individual's perception of his or her ability to organize and execute the behaviors necessary to manage disease. The goal of this study was to develop a valid and reliable measure of IBD-specific SE that can be used in clinical and research contexts. One hundred and twenty-two adults with a verified IBD diagnosis participated in the study. Data were pooled from 2 sources: patients from an outpatient university gastroenterology clinic (n=42) and a sample of online respondents (n=80). All participants (N=122) completed the IBD Self-Efficacy Scale (IBD-SES) and the Inflammatory Bowel Disease Questionnaire. Additionally, online participants completed the Brief Symptom Inventory-18 and the Rosenberg Self-Esteem Scale, whereas those in the clinic sample completed the Perceived Health Competence Scale, the Perceived Stress Questionnaire, and the Short Form Version 2 Health Survey. The IBD-SES was initially constructed to identify 4 distinct theoretical domains of self-efficacy: (1) managing stress and emotions, (2) managing medical care, (3) managing symptoms and disease, and (4) maintaining remission. The 29-item IBD-SES has high internal consistency (r=0.96), high test-retest reliability (r=0.90), and demonstrates strong construct and concurrent validity with established measures. The IBD-SES is a critical first step toward addressing an important psychological construct that could influence treatment outcomes in IBD.

Psychological Neuromodulatory Treatments for Young People with Chronic Pain

PubMed Central

Miró, Jordi; Castarlenas, Elena; de la Vega, Rocío; Roy, Rubén; Solé, Ester; Tomé-Pires, Catarina; Jensen, Mark P.

2016-01-01

The treatment of young people with chronic pain is a complex endeavor. Many of these youth do not obtain adequate relief from available interventions. Psychological neuromodulatory treatments have been shown to have potential benefit for adults with chronic pain. Here, we review and summarize the available information about the efficacy of three promising psychological neuromodulatory treatments—neurofeedback, meditation and hypnosis—when provided to young people with chronic pain. A total of 16 articles were identified and reviewed. The findings from these studies show that hypnotic treatments are effective in reducing pain intensity for a variety of pediatric chronic pain problems, although research suggests variability in outcomes as a function of the specific pain problem treated. There are too few studies evaluating the efficacy of neurofeedback or meditation training in young people with chronic pain to draw firm conclusions regarding their efficacy. However, preliminary data indicate that these treatments could potentially have positive effects on a variety of outcomes (e.g., pain intensity, frequency of pain episodes, physical and psychological function), at least in the short term. Clinical trials are needed to evaluate the effects of neurofeedback and meditation training, and research is needed to identify the moderators of treatment benefits as well as better understand the mechanisms underlying the efficacy of all three of these treatments. The findings from such research could enhance overall treatment efficacy by: (1) providing an empirical basis for better patient-treatment matching; and (2) identifying specific mechanisms that could be targeted with treatment. PMID:27929419

A pilot study of the comparative efficacy of 100 Hz magnetic seizure therapy and electroconvulsive therapy in persistent depression.

PubMed

Fitzgerald, Paul B; Hoy, Kate E; Elliot, David; McQueen, Susan; Wambeek, Lenore E; Chen, Leo; Clinton, Anne Maree; Downey, Glenn; Daskalakis, Zafiris J

2018-05-01

Magnetic seizure therapy (MST) is a novel brain stimulation technique that uses a high-powered transcranial magnetic stimulation device to produce therapeutic seizures. Preliminary MST studies have found antidepressant effects in the absence of cognitive side effects but its efficacy compared to electroconvulsive therapy (ECT) remains unclear. The aim of this study was to investigate the therapeutic efficacy and cognitive profile of MST compared to standard right unilateral ECT treatment. Thirty-seven patients completed a course of at least nine ECT or MST treatments in a randomized double-blind protocol. Assessments of depression severity and cognition were performed before and after treatment. No difference in the antidepressant effectiveness between the treatments was seen across any of the clinical outcome measures, although the overall response rates in both groups were quite low. In regards to cognition, following MST there were significant improvements in tests of psychomotor speed, verbal memory, and cognitive inhibition, with no reductions in cognitive performance. Following ECT there was significant improvement in only one of the cognitive inhibition tasks. With respect to the between-group comparisons, the MST group showed a significantly greater improvement on psychomotor speed than ECT. MST showed similar efficacy to right unilateral ECT in patients with treatment-resistant depression without cognitive side effects but in a sample that was only of sufficient size to demonstrate relatively large differences in response between the two groups. Future research should aim to optimize the methods of MST administration and compare its efficacy to ECT in large randomized controlled trials. © 2018 Wiley Periodicals, Inc.

Developing physical activity interventions for adults with spinal cord injury. Part 2: motivational counseling and peer-mediated interventions for people intending to be active.

PubMed

Latimer-Cheung, Amy E; Arbour-Nicitopoulos, Kelly P; Brawley, Lawrence R; Gray, Casey; Justine Wilson, A; Prapavessis, Harry; Tomasone, Jennifer R; Wolfe, Dalton L; Martin Ginis, Kathleen A

2013-08-01

The majority of people with spinal cord injury (SCI) do not engage in sufficient leisure-time physical activity (LTPA) to attain fitness benefits; however, many have good intentions to be active. This paper describes two pilot interventions targeting people with SCI who are insufficiently active but intend to be active (i.e., "intenders"). Study 1 examined the effects of a single, telephone-based counseling session on self-regulatory efficacy, intentions, and action plans for LTPA among seven men and women with paraplegia or tetraplegia. Study 2 examined the effects of a home-based strength-training session, delivered by a peer and a fitness trainer, on strength-training task self-efficacy, intentions, action plans, and behavior. Participants were 11 men and women with paraplegia. The counseling session (Study 1) yielded medium- to large-sized increases in participants' confidence to set LTPA goals and intentions to be active. The home visit (Study 2) produced medium- to large-sized increases in task self-efficacy, barrier self-efficacy, intentions, action planning, and strength-training behavior from baseline to 4 weeks after the visit. Study 1 findings provide preliminary evidence that a single counseling session can impact key determinants of LTPA among intenders with SCI. Study 2 findings demonstrate the potential utility of a peer-mediated, home-based strength training session for positively influencing social cognitions and strength-training behavior. Together, these studies provide evidence and resources for intervention strategies to promote LTPA among intenders with SCI, a population for whom LTPA interventions and resources are scarcely available.

Treatment of geographic atrophy by the topical administration of OT-551: results of a phase II clinical trial.

PubMed

Wong, Wai T; Kam, Waynekid; Cunningham, Denise; Harrington, Molly; Hammel, Keri; Meyerle, Catherine B; Cukras, Catherine; Chew, Emily Y; Sadda, Srinivas R; Ferris, Frederick L

2010-12-01

To investigate the safety and preliminary efficacy of OT-551, a disubstituted hydroxylamine with antioxidant properties, for the treatment of geographic atrophy (GA), the advanced atrophic form of age-related macular degeneration (AMD). The study was a single-center, open-label phase II trial, enrolling 10 participants with bilateral GA. Topical 0.45% OT-551 was administered in one randomly assigned eye three times daily for 2 years. Safety measures were assessed by complete ophthalmic examination, fundus photography, and review of symptoms. The primary efficacy outcome measure was the change in best corrected visual acuity at 24 months. Secondary efficacy measures included changes in area of GA, contrast sensitivity, microperimetry measurements, and total drusen area from baseline. Study drug was well tolerated and was associated with few adverse events. The mean change in BCVA at 2 years was +0.2 ± 13.3 letters in the study eyes and -11.3 ± 7.6 letters in fellow eyes (P = 0.0259). However, no statistically significant differences were found between the study and fellow eyes for all other secondary outcome measures. OT-551 was well tolerated by study participants and was not associated with any serious adverse effects. Efficacy measurements in this small study indicate a possible effect in maintaining visual acuity. However, the absence of significant effects on other outcomes measures in this study suggests that OT-551, in the current concentration and mode of delivery, may have limited or no benefit as a treatment for GA (ClinicalTrials.gov number, NCT00306488).

Transcranial Direct Current Stimulation in Epilepsy.

PubMed

San-Juan, Daniel; Morales-Quezada, León; Orozco Garduño, Adolfo Josué; Alonso-Vanegas, Mario; González-Aragón, Maricarmen Fernández; Espinoza López, Dulce Anabel; Vázquez Gregorio, Rafael; Anschel, David J; Fregni, Felipe

2015-01-01

Transcranial direct current stimulation (tDCS) is an emerging non-invasive neuromodulation therapy in epilepsy with conflicting results in terms of efficacy and safety. Review the literature about the efficacy and safety of tDCS in epilepsy in humans and animals. We searched studies in PubMed, MedLine, Scopus, Web of Science and Google Scholar (January 1969 to October 2013) using the keywords 'transcranial direct current stimulation' or 'tDCS' or 'brain polarization' or 'galvanic stimulation' and 'epilepsy' in animals and humans. Original articles that reported tDCS safety and efficacy in epileptic animals or humans were included. Four review authors independently selected the studies, extracted data and assessed the methodological quality of the studies using the recommendations of the Cochrane Handbook for Systematic Reviews of Interventions, PRISMA guidelines and Jadad Scale. A meta-analysis was not possible due to methodological, clinical and statistical heterogeneity of included studies. We analyzed 9 articles with different methodologies (3 animals/6 humans) with a total of 174 stimulated individuals; 109 animals and 65 humans. In vivo and in vitro animal studies showed that direct current stimulation can successfully induce suppression of epileptiform activity without neurological injury and 4/6 (67%) clinical studies showed an effective decrease in epileptic seizures and 5/6 (83%) reduction of inter-ictal epileptiform activity. All patients tolerated tDCS well. tDCS trials have demonstrated preliminary safety and efficacy in animals and patients with epilepsy. Further larger studies are needed to define the best stimulation protocols and long-term follow-up. Copyright © 2015 Elsevier Inc. All rights reserved.

Long-Term Chamomile Therapy of Generalized Anxiety Disorder: A Study Protocol for a Randomized, Double-Blind, Placebo- Controlled Trial.

PubMed

Mao, Jun J; Li, Qing S; Soeller, Irene; Rockwell, Kenneth; Xie, Sharon X; Amsterdam, Jay D

2014-11-01

Anxiety symptoms are among the most common reasons for consumers to use Complementary and Alternative Medicine (CAM) therapy. Although many botanicals have been proposed as putative remedies for anxiety symptoms, there has been a paucity of controlled trials of these remedies. A preliminary study of the anxiolytic effect of Chamomile ( Matricaria recutita ) in humans suggests that chamomile may have anxiolytic and antidepressant activity. We now seek to conduct a 5-year randomized, double-blind, placebo-substitution study to examine the short and long-term safety and efficacy of chamomile extract in Generalized Anxiety Disorder (GAD). 180 subjects with moderate to severe GAD will receive initial open-label pharmaceutical-grade chamomile extract 500-1,500 mg daily for 8 weeks. Responders to treatment who remain well for an additional 4 weeks of consolidation therapy, will be randomized to double-blind continuation therapy with either chamomile extract 500-1,500 mg daily or placebo for an additional 26 weeks. The primary outcome will be the time to relapse during study continuation therapy in each treatment condition. Secondary outcomes will include the proportion of subjects in each treatment condition who relapse, as well as the proportion of subjects with treatment-emergent adverse events. Quality of life ratings will also be compared between treatment conditions during short and long-term therapy. Many individuals with mental disorders decline conventional therapy and seek CAM therapies for their symptoms. Thus, the identification of effective CAM therapy is of relevance to reducing the burden of mental illness. This study builds upon our prior findings of significant superiority of chamomile versus placebo in reducing GAD symptoms. We now extend these preliminary findings by conducting a randomized long-term safety and efficacy study of chamomile in GAD.

Efficacy and mechanisms of action of traditional Chinese medicines for treating asthma and allergy.

PubMed

Li, Xiu-Min; Brown, Laverne

2009-02-01

Although corticosteroids and beta(2)-agonists are effective in managing asthma symptoms, a curative therapy for asthma is lacking. Traditional Chinese medicine (TCM), used in Asia for centuries, is beginning to play a role in Western health care as a complementary and alternative medicine modality. There is increasing scientific evidence supporting the use of TCM for asthma treatment. This review article discusses promising TCM interventions for asthma and explores their possible mechanisms of action. We first reviewed 5 clinical studies of antiasthma TCM herbal remedies published between 2005 and 2007. We then summarized possible mechanisms underlying their effects on the basis of data in the original articles, published abstracts, and available databases. Possible mechanisms include anti-inflammation, inhibition of airway smooth muscle contraction, and immunomodulation. Research on TCM herbal therapy for food allergy is rare, and we therefore focused on the effect and mechanism of action of food allergy herbal formula-2 on a murine model of peanut allergy and preliminary clinical study results. Evidence from clinical studies supports beneficial effects of TCM herbal therapy on asthma. A number of mechanisms may be responsible for efficacy of these agents. Strong preclinical study data suggest the potential efficacy of food allergy herbal formula-2 for food allergy.

Efficacy and mechanisms of action of traditional Chinese medicines for treating asthma and allergy

PubMed Central

Li, Xiu-Min; Brown, Laverne

2009-01-01

Background While corticosteroids and β-2 agonists are effective in managing asthma symptoms, a curative therapy for asthma is lacking. Traditional Chinese medicine (TCM), used in Asia for centuries, is beginning to play a role in Western health care as a complementary and alternative medicine (CAM) modality. There is increasing scientific evidence supporting the use of TCM for asthma treatment. Objective This review article discusses promising TCM interventions for asthma and explores their possible mechanisms of action. Methods We first reviewed five clinical studies of “anti-asthma” TCM herbal remedies published between 2005–2007. We then summarized possible mechanisms underlying their effects based on data in the original articles, published abstracts, and available data bases. Possible mechanisms include anti-inflammation, inhibition of airway smooth muscle contraction, and immunomodulation. Research on TCM herbal therapy for food allergy is rare, and we therefore focused on the effect and mechanism of action of Food Allergy Herbal Formula-2 (FAHF-2) on a murine model of peanut allergy and preliminary clinical study results. Conclusion Evidence from clinical studies supports beneficial effects of TCM herbal therapy on asthma. A number of mechanisms may be responsible for efficacy of these agents. Strong preclinical study data suggest potential efficacy of FAHF-2 for food allergy. PMID:19203653

A Customized Intervention for Dementia Caregivers: A Quasi-Experimental Design.

PubMed

Wawrziczny, Emilie; Larochette, Clotilde; Papo, David; Constant, Emilie; Ducharme, Francine; Kergoat, Marie-Jeanne; Pasquier, Florence; Antoine, Pascal

2018-04-01

The aim of this study is to test the effects of a customized intervention on distress among caregivers of persons with dementia (PWD) using a quasi-experimental design. Fifty-one spouse caregivers in the experimental group and 51 in the control group participated in the study. The effects of the intervention were examined by comparing caregivers' responses with questionnaires at pre-intervention baseline (T0) and immediately after intervention (T1). Differences were quantified using repeated-measures ANOVA. The analyses indicated a stabilizing effect of the intervention on caregivers' perceptions of PWD's daily functioning, self-esteem related to caregiving, quality of family support, and feeling of distress. Linear increases were observed regarding sense of preparedness and impact on daily routine, while no differences (interaction and linear effects) were observed for degree of self-efficacy, depression, impact on finances, or self-rated health. These findings show a preliminary efficacy of the intervention proposed in this study to prevent the exacerbation of caregivers' distress.

A systematic review of technology-based interventions for co-occurring substance use and trauma symptoms.

PubMed

Gilmore, Amanda K; Wilson, Sarah M; Skopp, Nancy A; Osenbach, Janyce E; Reger, Greg

2017-09-01

Introduction Technology-based mental health interventions are becoming increasingly common, and several have begun to target multiple outcomes in a single intervention. Recent developments in the treatment of co-occurring posttraumatic stress disorder and substance use disorder has led to the development and testing of technology-based interventions for these disorders. The current systematic review examined technology-based interventions designed to improve mental health outcomes among patients with co-occurring trauma symptoms and substance use. Methods Of 601 articles reviewed, 14 included a technology-based intervention for patients with these co-occurring problems. Results Seven of these studies provided preliminary evidence that technology-based interventions are likely to be efficacious in reducing either trauma symptoms or substance use. The seven remaining studies demonstrated that technology-based interventions for co-occurring trauma symptoms and substance use are feasible. Discussion This review suggests that technology-based interventions for co-occurring trauma symptoms and substance use are feasible, but more work is needed to assess efficacy using scientifically rigorous studies.

The Volunteering-in-Place (VIP) Program: Providing meaningful volunteer activity to residents in assisted living with mild cognitive impairment.

PubMed

Klinedinst, N Jennifer; Resnick, Barbara

2016-01-01

The Volunteering-in-Place (VIP) Program was developed to provide individualized meaningful volunteer activities matched to interests and capabilities for older adults with MCI in assisted living. The purposes of this single-site pre-test/post-test pilot study were to (1) establish feasibility of the VIP Program based on treatment fidelity (design, treatment, delivery, enactment); and (2) evaluate preliminary efficacy via improvement in psychological health (depressive symptoms, usefulness, purpose, resilience, and life satisfaction) and decreased sedentary activity (survey and Fitbit) at 3 and 6 months. Ten residents participated. The majority was white, female and educated, and on average 88 years old. The VIP Program was feasible and most participants continued to volunteer at 6 months. There were non-significant improvements in depressive symptoms, usefulness, purpose, resilience and recreational physical activity. The results of this study provide support for the feasibility of the VIP Program. Further study is necessary to examine efficacy. Copyright © 2016 Elsevier Inc. All rights reserved.

A Pilot Study of a Distress Tolerance Treatment for Opiate Dependent Patients Initiating Buprenorphine: Rationale, Methodology, and Outcomes

PubMed Central

Brown, Richard A.; Bloom, Erika Litvin; Hecht, Jacki; Moitra, Ethan; Herman, Debra S.; Stein, Michael D.

2016-01-01

Buprenorphine, an opioid that is a long-acting partial opiate agonist, is an efficacious treatment for opiate dependence that is growing in popularity. Nevertheless, evidence suggests that many patients will lapse within the first week of treatment, and that lapses are often associated with withdrawal-related or emotional distress. Recent research suggests that individuals’ reactions to this distress may represent an important treatment target. In the current study, we describe the development and outcomes from a preliminary pilot evaluation (N = 5) of a novel distress tolerance treatment for individuals initiating buprenorphine. This treatment incorporates exposure-based and acceptance-based treatment approaches that we have previously applied to the treatment of tobacco dependence. Results from this pilot study establish the feasibility and acceptability of this approach. We are now conducting a randomized controlled trial of this treatment that we hope will yield clinically significant findings and offer clinicians an efficacious behavioral treatment to complement the effects of buprenorphine. PMID:24973401

N-acetylcysteine – passe-partout or much ado about nothing?

PubMed Central

Aitio, Mirja-Liisa

2006-01-01

In experimental studies, the old mucolytic agent N-acetylcysteine (NAC) has had beneficial effects in disorders supposedly linked to oxidative stress. Numerous, mainly small clinical trials with variable doses have yielded inconsistent results in a wide variety of diseases. NAC added to the conventional therapy of human immunodeficiency virus infection might be of benefit; in respect of chronic obstructive pulmonary disease, systematic reviews and meta-analyses suggested that prolonged treatment with NAC is efficacious, but a recent multicentre study has questioned this. In a large intervention trial on cancer recurrence, NAC was ineffective. NAC infusions have been widely used in acute hepatic failure but convincing evidence of its benefits is lacking. A preliminary study reported that NAC is effective in preventing radiocontrast-induced nephropathy but thereafter highly mixed results have been published, and even meta-analyses disagree on its efficacy. In intensive care NAC has mostly been a disappointment but recently it has ‘given promises’ in surgery with cardiopulmonary bypass. NAC therapy is routine only in paracetamol intoxication. PMID:16390346

Augmenting Prolonged Exposure therapy for PTSD with intranasal oxytocin: A randomized, placebo-controlled pilot trial.

PubMed

Flanagan, Julianne C; Sippel, Lauren M; Wahlquist, Amy; Moran-Santa Maria, Megan M; Back, Sudie E

2018-03-01

Posttraumatic stress disorder (PTSD) is a chronic, debilitating condition for which Prolonged Exposure (PE) therapy is highly efficacious. However, for some individuals, premature dropout and residual PTSD symptoms remain obstacles. The neuropeptide oxytocin is a promising candidate to enhance PE due to its ability to enhance 1) prosocial cognition and behavior, which are theorized to promote positive working alliance, and 2) extinction learning, which is the central mechanism of action underlying successful PE treatment. Despite a robust theoretical rationale, no studies to date have combined evidence-based psychotherapy for PTSD with oxytocin. This randomized, placebo-controlled, double-blind pilot trial examined the feasibility, safety, and preliminary efficacy of augmenting PE with oxytocin. Participants were 17 individuals with diverse index traumas. Participants self-administered intranasal oxytocin (40 IU) or matching placebo 45 min prior to each weekly PE therapy session. One adverse event occurred in the placebo group and three individuals dropped out (17.6%; 2 oxytocin group and 1 placebo group). The oxytocin group demonstrated lower PTSD and depression symptoms during PE, and had higher working alliance scores, although these differences did not reach statistical significance. Although preliminary, the findings support the feasibility of oxytocin combined with PE. Adequately powered studies are necessary to determine whether oxytocin enhances PE treatment outcomes and to examine potential mechanisms, such as accelerating extinction learning, enhancing early response, and preventing premature dropout. NCT03238924. Copyright © 2017. Published by Elsevier Ltd.

Safety, pharmacokinetics, and preliminary clinical activity of inotuzumab ozogamicin, a novel immunoconjugate for the treatment of B-cell non-Hodgkin's lymphoma: results of a phase I study.

PubMed

Advani, Anjali; Coiffier, Bertrand; Czuczman, Myron S; Dreyling, Martin; Foran, James; Gine, Eva; Gisselbrecht, Christian; Ketterer, Nicolas; Nasta, Sunita; Rohatiner, Ama; Schmidt-Wolf, Ingo G H; Schuler, Martin; Sierra, Jorge; Smith, Mitchell R; Verhoef, Gregor; Winter, Jane N; Boni, Joseph; Vandendries, Erik; Shapiro, Mark; Fayad, Luis

2010-04-20

PURPOSE Inotuzumab ozogamicin (CMC-544) is an antibody-targeted chemotherapy agent composed of a humanized anti-CD22 antibody conjugated to calicheamicin, a potent cytotoxic agent. This was a phase I study to determine the maximum-tolerated dose (MTD), safety, and preliminary efficacy of inotuzumab ozogamicin in an expanded MTD cohort of patients with relapsed or refractory CD22(+) B-cell non-Hodgkin's lymphoma (NHL). PATIENTS AND METHODS Inotuzumab ozogamicin was administered intravenously as a single agent once every 3 or 4 weeks at doses ranging from 0.4 to 2.4 mg/m(2). Outcomes included MTD, safety, pharmacokinetics, response, progression-free survival (PFS), and overall survival. Results Seventy-nine patients were enrolled. The MTD was determined to be 1.8 mg/m(2). Common adverse events at the MTD were thrombocytopenia (90%), asthenia (67%), and nausea and neutropenia (51% each). The objective response rate at the end of treatment was 39% for the 79 enrolled patients, 68% for all patients with follicular NHL treated at the MTD, and 15% for all patients with diffuse large B-cell lymphoma treated at the MTD. Median PFS was 317 days (approximately 10.4 months) and 49 days for patients with follicular NHL and diffuse large B-cell lymphoma, respectively. CONCLUSION Inotuzumab ozogamicin has demonstrated efficacy against CD22(+) B-cell NHL, with reversible thrombocytopenia as the main toxicity.

The feasibility of a group stress management Liver SMART intervention for patients with end-stage liver disease: A pilot study.

PubMed

Jutagir, Devika R; Saracino, Rebecca M; Cunningham, Amy; Foran-Tuller, Kelly A; Driscoll, Mary A; Sledge, William H; Emre, Sukru H; Fehon, Dwain C

2018-06-04

Structured, empirically supported psychological interventions are lacking for patients who require organ transplantation. This stage IA psychotherapy development project developed and tested the feasibility, acceptability, tolerability, and preliminary efficacy of an 8-week group cognitive behavioral stress management intervention adapted for patients with end-stage liver disease awaiting liver transplantation. Twenty-nine English-speaking United Network for Organ Sharing-registered patients with end-stage liver disease from a single transplantation center enrolled in 8-week, group cognitive-behavioral liver stress management and relaxation training intervention adapted for patients with end-stage liver disease. Patients completed pre- and postintervention surveys that included the Beck Depression Inventory II and the Beck Anxiety Inventory. Feasibility, acceptability, tolerability, and preliminary efficacy were assessed.ResultAttendance rate was 69.40%. The intervention was rated as "good" to "excellent" by 100% of participants who completed the postintervention survey in teaching them new skills to relax and to cope with stress, and by 94.12% of participants in helping them feel supported while waiting for a liver transplant. No adverse events were recorded over the course of treatment. Attrition was 13.79%. Anxious and depressive symptoms were not statistically different after the intervention.Significance of resultsThe liver stress management and relaxation training intervention is feasible, acceptable, and tolerable to end-stage liver disease patients within a transplant clinic setting. Anxious and depressive symptoms remained stable postintervention. Randomized controlled trials are needed to study the intervention's effectiveness in this population.

Integrating virtual reality with activity management for the treatment of fibromyalgia: acceptability and preliminary efficacy.

PubMed

Garcia-Palacios, Azucena; Herrero, Rocio; Vizcaíno, Yolanda; Belmonte, Miguel A; Castilla, Diana; Molinari, Guadalupe; Baños, Rosa Maria; Botella, Cristina

2015-06-01

Cognitive-behavioral therapies (CBT) for fibromyalgia syndrome (FMS) are important interventions in the management of this condition. Empirical evidence reports that although the results are promising, further research is needed to respond more appropriately to these patients. This study focuses on exploring the use of Virtual Reality (VR) as an adjunct to the activity management component. The aim of this study is to present the results of a small-sized randomized controlled trial to test the preliminary efficacy and acceptability of this component. The final sample was composed of 61 women diagnosed with FMS according to the American College of Rheumatology. The sample was randomly allocated to 2 conditions: VR treatment and treatment as usual. Participants in the VR condition achieved significant improvements in the primary outcome: disability measured with the FIQ. The improvement was also significant in secondary outcomes, such as perceived quality of life and some of the coping strategies included in the Chronic Pain Coping Inventory: task persistence and exercise. There were no differences in other secondary outcome measures like pain intensity and interference and depression. Participants reported high satisfaction with the VR component. The effects were related to the psychological aspects targeted in the treatment. The component was well accepted by FMS patients referred from a public hospital. These findings show that the VR component could be useful in the CBT treatment of FMS and encourage us to continue exploring the use of integrating VR with CBT interventions for the treatment of FMS.

The Aspirin Regimens in Essential Thrombocythemia (ARES) phase II randomized trial design: Implementation of the serum thromboxane B2 assay as an evaluation tool of different aspirin dosing regimens in the clinical setting.

PubMed

De Stefano, Valerio; Rocca, Bianca; Tosetto, Alberto; Soldati, Denise; Petrucci, Giovanna; Beggiato, Eloise; Bertozzi, Irene; Betti, Silvia; Carli, Giuseppe; Carpenedo, Monica; Cattaneo, Daniele; Cavalca, Viviana; Dragani, Alfredo; Elli, Elena; Finazzi, Guido; Iurlo, Alessandra; Lanzarone, Giuseppe; Lissandrini, Laura; Palandri, Francesca; Paoli, Chiara; Rambaldi, Alessandro; Ranalli, Paola; Randi, Maria Luigia; Ricco, Alessandra; Rossi, Elena; Ruggeri, Marco; Specchia, Giorgina; Timillero, Andrea; Turnu, Linda; Vianelli, Nicola; Vannucchi, Alessandro M; Rodeghiero, Francesco; Patrono, Carlo

2018-06-01

Once-daily (od), low-dose aspirin (75-100 mg) is recommended to reduce the thrombotic risk of patients with essential thrombocytemia (ET). This practice is based on data extrapolated from other high-risk patients and an aspirin trial in polycythemia vera, with the assumption of similar aspirin pharmacodynamics in the two settings. However, the pharmacodynamics of low-dose aspirin is impaired in ET, reflecting accelerated renewal of platelet cyclooxygenase (COX)-1. ARES is a parallel-arm, placebo-controlled, randomized, dose-finding, phase II trial enrolling 300 ET patients to address two main questions. First, whether twice or three times 100 mg aspirin daily dosing is superior to the standard od regimen in inhibiting platelet thromboxane (TX)A 2 production, without inhibiting vascular prostacyclin biosynthesis. Second, whether long-term persistence of superior biochemical efficacy can be safely maintained with multiple vs. single dosing aspirin regimen. Considering that the primary study end point is serum TXB 2 , a surrogate biomarker of clinical efficacy, a preliminary exercise of reproducibility and validation of this biomarker across all the 11 participating centers was implemented. The results of this preliminary phase demonstrate the importance of controlling reproducibility of biomarkers in multicenter trials and the feasibility of using serum TXB 2 as a reliable end point for dose-finding studies of novel aspirin regimens.

A Preliminary Randomized Controlled Trial of a Behavioral Exercise Intervention for Smoking Cessation

PubMed Central

Bloom, Erika Litvin; Strong, David R.; Riebe, Deborah; Marcus, Bess H.; Desaulniers, Julie; Fokas, Kathryn; Brown, Richard A.

2014-01-01

Introduction: Previous exercise intervention studies for smoking cessation have been challenged by a number of methodological limitations that confound the potential efficacy of aerobic exercise for smoking cessation. Methods: The preliminary efficacy of a behavioral exercise intervention that incorporated features designed to address prior limitations was tested in a randomized controlled trial (RCT). Sixty-one smokers (65.6% female, mean age = 47.3 years, smoked a mean of 19.7 cigarettes/day) were randomized to receive either a 12-week exercise intervention or a 12-week health education contact control. Participants in both conditions received an 8-week telephone-delivered, standard smoking cessation protocol (with the transdermal nicotine patch). Follow-ups were conducted at the end of treatment (EOT), 6- and 12-month timepoints. Results: There were no differences between conditions with respect to the number of weekly exercise or health education sessions attended (9.3±2.8 vs. 9.3±3.0, respectively). While not statistically significant, participants in the exercise condition demonstrated higher verified abstinence rates (EOT: 40% vs. 22.6%, odds ratio [OR] = 2.28; 6- and 12-month follow-ups: 26.7% vs. 12.9%, OR = 2.46). Irrespective of treatment condition, higher levels of moderate-to-vigorous exercise were associated with lower levels of depressive symptoms during the intervention. Conclusions: The results of this small RCT point toward the benefit of a behavioral exercise intervention designed to address previous methodological limitations for smoking cessation. Given the potential public health impact of the demonstrated efficacy of exercise for smoking cessation, the continued development and optimization of exercise interventions for smokers through larger RCTs merits pursuit. PMID:24812023

The self-efficacy in patient-centeredness questionnaire - a new measure of medical student and physician confidence in exhibiting patient-centered behaviors.

PubMed

Zachariae, Robert; O'Connor, Maja; Lassesen, Berit; Olesen, Martin; Kjær, Louise Binow; Thygesen, Marianne; Mørcke, Anne Mette

2015-09-15

Patient-centered communication is a core competency in modern health care and associated with higher levels of patient satisfaction, improved patient health outcomes, and lower levels of burnout among physicians. The objective of the present study was to develop a questionnaire assessing medical student and physician self-efficacy in patient-centeredness (SEPCQ) and explore its psychometric properties. A preliminary 88-item questionnaire (SEPCQ-88) was developed based on a review of the literature and medical student portfolios and completed by 448 medical students from Aarhus University. Exploratory Principal Component analysis resulted in a 27-item version (SEPCQ-27) with three underlying self-efficacy factors: 1) Exploring the patient perspective, 2) Sharing information and power, and 3) Dealing with communicative challenges. The SEPCQ-27 was completed by an independent sample of 291 medical students from 2 medical schools and 101 hospital physicians. Internal consistencies of total and subscales were acceptable for both students and physicians (Cronbach's alpha (range): 0.74-0.95). There were no overall indications of gender-related differential item function (DIF), and a Confirmatory Factor Analysis (CFA) indicated good fit (CFI = 0.98; NNFI = 0.98; RMSEA = 0.05; SRMR = 0.07). Responsiveness was indicated by increases in SEPCQ scores after a course in communication and peer-supervision (Cohen's d (range): 0.21 to 0.73; p: 0.053 to 0.001). Furthermore, positive associations were found between increases in SEPCQ-scores and course-related motivation to learn (medical students) and between SEPCQ scores and years of clinical experience (physicians). The final SEPCQ-27 showed satisfactory psychometric properties, and preliminary support was found for its construct validity, indicating that the SEPCQ-27 may be a valuable measure in future patient centered communication training and research.

Piloting an email-based resource package for job seekers with multiple sclerosis.

PubMed

Dorstyn, Diana; Roberts, Rachel; Murphy, Gregory; Kneebone, Ian; Migliorini, Christine; Craig, Ashley; Hutchinson, Claire; Field, Deborah

2017-05-01

Media-based rehabilitation provides a powerful opportunity to examine vocational behaviors in the disability sector. However, this research is preliminary at best. This paper reports pilot data. Eighteen adults with multiple sclerosis (MS) accessed an email-delivered, resource-based package, Work and MS. Pre- and post-access vocational self-efficacy and identity (Job-Procurement Self Efficacy Scale, My Vocational Situation Scale- primary outcomes), life orientation and depressed mood (Life Orientation Test - revised and Patient Health Questionnaire-9 - secondary outcomes) were assessed. Pre- and post-change scores were examined with Wilcoxon signed ranks tests and Hedges g effect sizes with associated 95% confidence intervals. Reliable change analyses were additionally calculated to determine the clinical significance of individual change scores. Significant and positive effects were reported for vocational self-efficacy, identity, and optimism. Reliable change scores in one or more of these key outcomes were reported by 30% of the sample. Satisfaction with the content and delivery of the email-based intervention was also noted. Preliminary evidence suggests that Work and MS can help to promote vocational goals, interests and strengths among job seekers with a disability by providing a set of tools, information and linkages relating to vocational pursuits and career development. Replication with a randomized control design is indicated. Implications for Rehabilitation Research indicates a high unemployment rate among working-age adults with MS. A combination of disease-specific, psychological, programmatic and societal variables contribute to employment instability in this group. This pilot study demonstrates that an e-mail-based resource package, Work and MS, provides an innovative and feasible option for promoting consumer engagement with vocational services and, potentially, improving vocational outcomes. Work and MS has potential applicability to other disability groups.

Understanding the Perception of Global Climate Change: Research into the Role of Media

NASA Astrophysics Data System (ADS)

Kundargi, R.; Gopal, S.; Tsay-Vogel, M.

2016-12-01

Here we present preliminary results for a novel study investigating the perception of climate change media, in relation to two pre-selected dimensions. We administer a questionnaire varying in two dimensions (spatial proximity and scientific literacy) to 155 mostly students in order to evaluate their emotional and cognitive reactions towards a series of video clips depicting the impacts of global climate change (GCC) events or the science behind global climate change. 19 videos were selected and vetted by experts for content and relevance to the subject matter. Our preliminary analysis indicate that the further away an event is perceived to be (spatial proximity) results in a lower uncertainty about the risks of GCC, lower self-efficacy to effect GCC, and lower personal responsibility to influence GCC. Furthermore, our results show that videos with a higher perceived background scientific knowledge requirement (scientific literacy) results in greater viewer engagement with the video. A full analysis and results of this study will be presented within the poster presentation.

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.

The efficacy of initial hydrocortisone administration at preventing posttraumatic distress in adult trauma patients: a randomized trial

PubMed Central

Delahanty, Douglas L.; Gabert-Quillen, Crystal; Ostrowski, Sarah A.; Nugent, Nicole R.; Fischer, Beth; Morris, Adam; Pitman, Roger K.; Bon, John; Fallon, William

2013-01-01

Objective/Introduction Secondary pharmacological interventions have shown promise at reducing the development of posttraumatic stress disorder symptoms (PTSS) in preclinical studies. The present study examined the preliminary efficacy of a 10-day low-dose (20 mg bid) course of hydrocortisone at preventing PTSS in traumatic injury victims. Methods Sixty-four traumatic injury patients (34% female) were randomly assigned in a double-blind protocol to receive either a 10-day course of hydrocortisone or placebo initiated within 12 hours of the trauma. One-month and 3-months posttrauma participants completed an interview to assess PTSS and self-report measures of depression and health-related quality of life. Results Hydrocortisone recipients reported fewer PTSD and depression symptoms, and had greater improvements in health-related quality of life during the first 3 months posttrauma than did placebo recipients. Hydrocortisone recipients who had never received prior mental health treatment had the lowest PTSD scores. Conclusion Low-dose hydrocortisone may be a promising approach to the prevention of PTSD in acutely injured trauma patients, and may be particularly efficacious in acutely injured trauma victims without a history of significant psychopathology. PMID:23557627

Comparative anti-microbial efficacy of Azadirachta indica irrigant with standard endodontic irrigants: A preliminary study

PubMed Central

Dutta, Arindam; Kundabala, Mala

2014-01-01

Objective: The anti-microbial efficacy of 2.5% sodium hypochlorite (SHC) and 0.2% chlorhexidine gluconate were compared with an experimental irrigant formulated from the Neem tree, Azadirachta indica A. Juss. Materials and Methods: A sample of 36 single rooted anterior teeth with periapical radiolucency and absence of response to vitality tests that required root canal treatment were selected for this study. The test irrigants and their combinations were assigned to five different groups and saline served as the control. Access cavities were prepared using an aseptic technique and samples collected for both anaerobic culture and Gram stained smears, followed by irrigation and sample collection again. The number of organisms were expressed in colony forming units/ml after 72 h of incubation; the smears were analyzed for their microbial loads and tissue clearance and assessed as per defined criteria. Results: Our results found the maximum reduction in microbial loads, when analyzed by culture method, with a combination of SHC and the experimental neem irrigant. Maximum tissue clearance on the Gram Stained smears was also found with the same combination. Conclusion: Neem irrigant has anti-microbial efficacy and can be considered for endodontic use. PMID:24778508

The Worksite Heart Health Improvement Project (WHHIP): feasibility and efficacy.

PubMed

Flannery, Kelly; Resnick, Barbara; Galik, Elizabeth; Lipscomb, Jane; McPhaul, Kathleen; Shaughnessy, Marianne

2012-01-01

Test the feasibility and efficacy of the Worksite Heart Health Improvement Project (WHHIP). The WHHIP was a quasi-experimental 6-month pilot performed in 2 long-term care facilities. Thirty-nine female minority nursing assistants participated in this study with a mean age of 42.39 (SD = 12.79) years. Measures were collected at baseline, 3, and 6 months and included blood pressure, lipid panel, body mass index, physical activity levels, diet behaviors, depressive symptoms, and self-efficacy outcomes. The 3-month WHHIP intervention included 3 components: environmental and policy assessment; education; and on-going motivation. The control site received education only. Subject participation averaged 47% and 58% in exercise and diet related activities, respectively. Generalized estimating equations showed the treatment group showed significant improvements in depressive symptoms (p = .012), systolic blood pressure (p = .028), total cholesterol (p = .002) and triglycerides (p = .011) over time. The treatment group also showed trends for improvement in diet behaviors (p = .069) and diastolic blood pressure (p = .073). This study provided feasibility evidence for the WHHIP and preliminary evidence that the WHHIP can improve heart healthy behaviors and subsequent outcomes among nursing assistants in long-term care settings. © 2012 Wiley Periodicals, Inc.

A Brief Report: Lessons Learned and Preliminary Findings of Progreso en Salud, an HIV Risk Reduction Intervention for Latina Seasonal Farmworkers.

PubMed

Kanamori, Mariano; De La Rosa, Mario; Diez, Stephanie; Weissman, Jessica; Trepka, Mary Jo; Sneij, Alicia; Schmidt, Peter; Rojas, Patria

2016-12-30

Throughout the past decade, HIV rates in Florida-particularly South Florida, where many Latina seasonal farmworkers reside and work-have ranked among the highest in the nation. In this brief report, we delineate important lessons learned and preliminary findings from the implementation of the HIV prevention intervention Progreso en Salud (Progress in Health). Among the 114 Latina seasonal farmworker participants, there were significant increases from baseline to 6-month follow-up in the percentages of overall condom use, HIV testing, HIV/AIDS-related communications with friends, HIV knowledge, condom use self-efficacy, and correct use of condoms. Lessons learned from this study can be used to inform future HIV intervention strategies to improve the adoption and maintenance of HIV risk reduction behaviors among high-risk Latina seasonal workers and other high-risk underserved populations. Future research is needed to support our findings.

The Mothers and Toddlers Program, an attachment-based parenting intervention for substance using women: Post-treatment results from a randomized clinical pilot

PubMed Central

Suchman, Nancy E.; DeCoste, Cindy; Castiglioni, Nicole; McMahon, Thomas J.; Rounsaville, Bruce; Mayes, Linda

2010-01-01

This is a report of post-treatment findings from a completed randomized pilot study testing the preliminary efficacy of The Mothers and Toddlers Program (MTP), a 12 week attachment-based individual parenting therapy for mothers enrolled in substance abuse treatment and caring for children ages birth to 36 months. Forty-seven mothers were randomized to MTP versus the Parent Education Program (PE) – a comparison intervention providing individual case management and child guidance brochures. At post-treatment, MTP mothers demonstrated better reflective functioning in the Parent Development Interview, representational coherence and sensitivity, and caregiving behavior than PE mothers. Partial support was also found for proposed mechanisms of change in the MTP model. Together, preliminary findings suggest that attachment-based interventions may be more effective than traditional parent training for enhancing relationships between substance using women and their young children. PMID:20730641

A Brief Report: Lessons Learned and Preliminary Findings of Progreso en Salud, an HIV Risk Reduction Intervention for Latina Seasonal Farmworkers

PubMed Central

Kanamori, Mariano; De La Rosa, Mario; Diez, Stephanie; Weissman, Jessica; Trepka, Mary Jo; Sneij, Alicia; Schmidt, Peter; Rojas, Patria

2016-01-01

Throughout the past decade, HIV rates in Florida—particularly South Florida, where many Latina seasonal farmworkers reside and work—have ranked among the highest in the nation. In this brief report, we delineate important lessons learned and preliminary findings from the implementation of the HIV prevention intervention Progreso en Salud (Progress in Health). Among the 114 Latina seasonal farmworker participants, there were significant increases from baseline to 6-month follow-up in the percentages of overall condom use, HIV testing, HIV/AIDS-related communications with friends, HIV knowledge, condom use self-efficacy, and correct use of condoms. Lessons learned from this study can be used to inform future HIV intervention strategies to improve the adoption and maintenance of HIV risk reduction behaviors among high-risk Latina seasonal workers and other high-risk underserved populations. Future research is needed to support our findings. PMID:28042852

Teaching Group Work with "The Great Debaters"

ERIC Educational Resources Information Center

Moe, Jeffry; Autry, Linda; Olson, Joann S.; Johnson, Kaprea F.

2014-01-01

An experiential learning activity, based on the film "The Great Debaters" (Washington, D., 2007), was used during a group work class. Description and preliminary evaluation of the activity is provided, including analysis of participant scores on the group leader self-efficacy instrument at multiple points. Implications and future…

Religious versus Conventional Psychotherapy for Major Depression in Patients with Chronic Medical Illness: Rationale, Methods, and Preliminary Results

PubMed Central

Koenig, Harold G.

2012-01-01

This paper (1) reviews the physical and religious barriers to CBT that disabled medically ill-depressed patients face, (2) discusses research on the relationship between religion and depression-induced physiological changes, (3) describes an ongoing randomized clinical trial of religious versus secular CBT in chronically ill patients with mild-to-moderate major depression designed to (a) overcome physical and religious barriers to CBT and (b) compare the efficacy of religious versus secular CBT in relieving depression and improving immune and endocrine functions, and (4) presents preliminary results that illustrate the technical difficulties that have been encountered in implementing this trial. CBT is being delivered remotely via instant messaging, telephone, or Skype, and Christian, Jewish, Muslim, Buddhist, and Hindu versions of religious CBT are being developed. The preliminary results described here are particular to the technologies employed in this study and are not results from the CBT clinical trial whose findings will be published in the future after the study ends and data are analyzed. The ultimate goal is to determine if a psychotherapy delivered remotely that integrates patients' religious resources improves depression more quickly than a therapy that ignores them, and whether religious CBT is more effective than conventional CBT in reversing depression-induced physiological changes. PMID:22778932

Mindfulness-based stress reduction for people living with HIV/AIDS: preliminary review of intervention trial methodologies and findings.

PubMed

Riley, Kristen E; Kalichman, Seth

2015-01-01

In the context of successful antiretroviral therapy (ART) for the management of HIV infection, the harmful effects of stress remain a significant threat. Stress may increase viral replication, suppress immune response, and impede adherence to ART. Stressful living conditions of poverty, facing a chronic life-threatening illness and stigma all exacerbate chronic stress in HIV-affected populations. Stress-reduction interventions are urgently needed for the comprehensive care of people living with HIV. Mindfulness-based stress reduction (MBSR) is one approach that has shown promise as an intervention for patients facing other medical conditions for reducing disease progression, psychological distress and maladaptive behaviours. In this systematic review, we identified 11 studies that have examined MBSR as an intervention for HIV-positive populations. Of the studies, six were randomised designs, one was a quasi-experimental design, and the remaining four were pre- and post-test designs. The preliminary outcomes support MBSR to decrease emotional distress with mixed evidence for impact on disease progression. Effect sizes were generally small to moderate in magnitude. The early findings from this emerging literature must be considered preliminary and support moving forward with more rigorous controlled trials, evaluated with objective assessments in longer-term follow-ups to determine the efficacy of MBSR for people living with HIV.

Efficacy of Barium-Based Fecal Tagging for CT Colonography: a Comparison between the Use of High and Low Density Barium Suspensions in a Korean Population - a Preliminary Study

PubMed Central

Kim, Min Ju; Lee, Seung Soo; Byeon, Jeong-Sik; Choi, Eugene K.; Kim, Jung Hoon; Kim, Yeoung Nam; Kim, Ah Young; Ha, Hyun Kwon

2009-01-01

Objective This preliminarily study was designed to determine and to compare the efficacy of two commercially available barium-based fecal tagging agents for CT colonography (CTC) (high-density [40% w/v] and low-density [4.6% w/v] barium suspensions) in a population in Korea. Materials and Methods In a population with an identified with an average-risk for colorectal cancer, 15 adults were administered three doses of 20 ml 40% w/v barium for fecal tagging (group I) and 15 adults were administered three doses of 200 ml 4.6% w/v barium (group II) for fecal tagging. Excluding five patients in group I and one patient in group II that left the study, ten patients in group I and 14 patients in group II were finally included in the analysis. Two experienced readers evaluated the CTC images in consensus regarding the degree of tagging of stool pieces 6 mm or larger. Stool pieces were confirmed with the use of standardized CTC criteria or the absence of matched lesions as seen on colonoscopy. The rates of complete fecal tagging were analyzed on a per-lesion and a per-segment basis and were compared between the patients in the two groups. Results Per-lesion rates of complete fecal tagging were 52% (22 of 42; 95% CI, 37.7-66.6%) in group I and 78% (28 of 36; 95% CI, 61.7-88.5%) in group II. The difference between the two groups did not reach statistical significance (p = 0.285). The per-segment rates of complete tagging were 33% (6 of 18; 95% CI, 16.1%-56.4%) in group I and 60% (9 of 15; 95% CI, 35.7%-80.3%) in group II; again, the difference between the two groups did not reach statistical significance (p = 0.171). Conclusion Barium-based fecal tagging using both the 40% w/v and the 4.6% w/v barium suspensions showed moderate tagging efficacy. The preliminary comparison did not demonstrate a statistically significant difference in the tagging efficacy between the use of the two tagging agents, despite the tendency toward better tagging with the use of the 4.6% w/v barium suspension. PMID:19182500

Preliminary investigations on the utility of an erbium, chromium YSGG laser.

PubMed

Eversole, L R; Rizoiu, I M

1995-12-01

A variety of laser systems are under investigation as potential tools in dentistry. Most of these systems have been shown to be efficacious for soft tissue surgery of the mucous membranes; however, cutting bone and dental hard tissues has only recently been possible. In this report from the University of California at Los Angeles School of Dentistry, a review of laser applications in dentistry is discussed. The utility of a new laser system using an erbium YSGG medium with air water spray to cut soft tissues, bone, enamel and dentin is under investigation and preliminary research findings are presented.

Empowering bystanders to prevent campus violence against women: a preliminary evaluation of a poster campaign.

PubMed

Potter, Sharyn J; Moynihan, Mary M; Stapleton, Jane G; Banyard, Victoria L

2009-01-01

Researchers at a midsized public northeastern university evaluated the efficacy of a poster campaign to determine if students increase their knowledge of prosocial bystander behaviors and willingness to intervene in instances of sexual violence after viewing a series of campaign posters where student actors model appropriate bystander behaviors. During the last week of the campaign, undergraduates were invited to participate in a Web survey. The results of this preliminary evaluation indicate promising variation in the awareness of students who reported seeing the campaign compared to those who did not.

A Powered Lower Limb Orthosis for Providing Legged Mobility in Paraplegic Individuals.

PubMed

Quintero, Hugo A; Farris, Ryan J; Hartigan, Clare; Clesson, Ismari; Goldfarb, Michael

2011-01-01

This paper presents preliminary results on the development of a powered lower limb orthosis intended to provide legged mobility (with the use of a stability aid, such as forearm crutches) to paraplegic individuals. The orthosis contains electric motors at both hip and both knee joints, which in conjunction with ankle-foot orthoses, provides appropriate joint kinematics for legged locomotion. The paper describes the orthosis and the nature of the controller that enables the SCI patient to command the device, and presents data from preliminary trials that indicate the efficacy of the orthosis and controller in providing legged mobility.

Design, synthesis and preliminary biological evaluation of indoline-2,3-dione derivatives as novel HDAC inhibitors.

PubMed

Jin, Kang; Li, Shanshan; Li, Xiaoguang; Zhang, Jian; Xu, Wenfang; Li, Xuechen

2015-08-01

Histone deacetylases (HDACs) are zinc-dependent or NAD(+) dependent enzymes and play a critical role in the process of tumor development. Herein a series of indoline-2,3-dione derivatives have been designed and synthesized as potential HDACs inhibitors. The preliminary biological evaluation showed that most compounds synthesized have exhibited moderate Hela cell nuclear extract inhibitory activities, among which compound 25a (IC50=10.13 nM) has shown the best efficacy. The anti-proliferative activities of some of these compounds were also discussed. Copyright © 2015. Published by Elsevier Ltd.

Do Research Intermediaries Reduce Perceived Coercion to Enter Research Trials Among Criminally Involved Substance Abusers?

PubMed

Festinger, David S; Dugosh, Karen L; Croft, Jason R; Arabia, Patricia L; Marlowe, Douglas B

2011-01-01

We examined the efficacy of including a research intermediary (RI) during the consent process in reducing participants' perceptions of coercion to enroll in a research study. Eighty-four drug court clients being recruited into an ongoing study were randomized to receive a standard informed consent process alone (standard condition) or with an RI (intermediary condition). Before obtaining consent, RIs met with clients individually to discuss remaining concerns. Findings provided preliminary evidence that RIs reduced client perceptions that their participation might influence how clinical and judicial staff view them. This suggests that using RIs may improve participant autonomy in clinical studies.

Do Research Intermediaries Reduce Perceived Coercion to Enter Research Trials Among Criminally Involved Substance Abusers?

PubMed Central

Festinger, David S.; Dugosh, Karen L.; Croft, Jason R.; Arabia, Patricia L.; Marlowe, Douglas B.

2011-01-01

We examined the efficacy of including a research intermediary (RI) during the consent process in reducing participants’ perceptions of coercion to enroll in a research study. Eighty-four drug court clients being recruited into an ongoing study were randomized to receive a standard informed consent process alone (standard condition) or with an RI (intermediary condition). Before obtaining consent, RIs met with clients individually to discuss remaining concerns. Findings provided preliminary evidence that RIs reduced client perceptions that their participation might influence how clinical and judicial staff view them. This suggests that using RIs may improve participant autonomy in clinical studies. PMID:22081751

A review of treatment of premenstrual syndrome and premenstrual dysphoric disorder.

PubMed

Rapkin, Andrea

2003-08-01

Severe premenstrual syndrome (PMS) and, more recently, premenstrual dysphoric disorder (PMDD) have been studied extensively over the last 20 years. The defining criteria for diagnosis of the disorders according to the American College of Obstetricians and Gynecologists (ACOG) include at least one moderate to severe mood symptom and one physical symptom for the diagnosis of PMS and by DSM IV criteria a total of 5 symptoms with 1 severe mood symptom for the diagnosis of PMDD. There must be functional impairment attributed to the symptoms. The symptoms must be present for one to two weeks premenstrually with relief by day 4 of menses and should be documented prospectively for at least two cycles using a daily rating form. Nonpharmacologic management with some evidence for efficacy include cognitive behavioral relaxation therapy, aerobic exercise, as well as calcium, magnesium, vitamin B(6) L-tryptophan supplementation or a complex carbohydrate drink. Pharmacologic management with at least ten randomized controlled trials to support efficacy include selective serotonin reuptake inhibitors administered daily or premenstrually and serotonergic tricyclic antidepressants. Anxiolytics and potassium sparing diuretics have demonstrated mixed results in the literature. Hormonal therapy is geared towards producing anovulation. There is good clinical evidence for GnRH analogs with addback hormonal therapy, danocrine, and estradiol implants or patches with progestin to protect the endometrium. Oral contraceptive pills prevent ovulation and should be effective for the treatment of PMS/PMDD. However, limited evidence does not support efficacy for oral contraceptive agents containing progestins derived from 19-nortestosterone. The combination of the estrogen and progestin may produce symptoms similar to PMS, such as water retention and irritability. There is preliminary evidence that a new oral contraceptive pill containing low-dose estrogen and the progestin drospirenone, a spironolactone analog, instead of a 19-nortestosterone derivative can reduce symptoms of water retention and other side effects related to estrogen excess. The studies are in progress, however, preliminary evidence suggests that the drospirenone-containing pill called Yasmin may be effective the treatment of PMDD.

Reliability and validity of the parent efficacy for child healthy weight behaviour (PECHWB) scale.

PubMed

Palmer, F; Davis, M C

2014-05-01

Interventions for childhood overweight and obesity that target parents as the agents of change by increasing parent self-efficacy for facilitating their child's healthy weight behaviours require a reliable and valid tool to measure parent self-efficacy before and after interventions. Nelson and Davis developed the Parent Efficacy for Child Healthy Weight Behaviour (PECHWB) scale with good preliminary evidence of reliability and validity. The aim of this research was to provide further psychometric evidence from an independent Australian sample. Data were provided by a convenience sample of 261 primary caregivers of children aged 4-17 years via an online survey. PECHWB scores were correlated with scores on other self-report measures of parenting efficacy and 2- to 4-week test-retest reliability of the PECHWB was assessed. The results of the study confirmed the four-factor structure of the PECHWB (Fat and Sugar, Sedentary Behaviours, Physical Activity, and Fruit and Vegetables) and provided strong evidence of internal consistency and test-retest reliability, as well as good evidence of convergent validity. Future research should investigate the properties of the PECHWB in a sample of parents of overweight or obese children, including measures of child weight and actual child healthy weight behaviours to provide evidence of the concurrent and predictive validity of PECHWB scores. © 2013 John Wiley & Sons Ltd.

Tolerance and Efficacy of Sodium Oxybate in Childhood Narcolepsy with Cataplexy: A Retrospective Study

PubMed Central

Lecendreux, Michel; Poli, Francesca; Oudiette, Delphine; Benazzouz, Fatima; Donjacour, Claire E.H.M; Franceschini, Christian; Finotti, Elena; Pizza, Fabio; Bruni, Oliviero; Plazzi, Giuseppe

2012-01-01

Narcolepsy with cataplexy is a sleep disorder characterized by excessive daytime sleepiness, irresistible sleep episodes, and sudden loss of muscle tone (cataplexy) mostly triggered by emotions. Narcolepsy with cataplexy is a disabling lifelong disorder frequently arising during childhood. Pediatric narcolepsy often results in severe learning and social impairment. Improving awareness about this condition increases early diagnosis and may allow patients to rapidly access adequate treatments, including pharmacotherapy and/or non-medication-based approaches. Even though children currently undergo pharmacotherapy, data about safety and efficacy in the pediatric population are scarce. Lacking international guidelines as well as drugs registered for childhood narcolepsy with cataplexy, physicians have no other alternative but to prescribe in an off-label manner medications identical to those recommended for adults. We retrospectively evaluated 27 children ranging from 6 to 16 years old, suffering from narcolepsy with cataplexy, who had been treated with off-label sodium oxybate and had been followed in a clinical setting. Throughout a semi-structured interview, we documented the good efficacy and tolerability of sodium oxybate in the majority of the patients. This study constitutes a preliminary step towards a further randomized controlled trial in childhood narcolepsy with cataplexy. Citation: Lecendreux M; Poli F; Oudiette D; Benazzouz F; Donjacour CEHM; Franceschini C; Finotti E; Pizza F; Bruni O; Plazzi G. Tolerance and efficacy of sodium oxybate in childhood narcolepsy with cataplexy: a retrospective study. SLEEP 2012;35(5):709-711. PMID:22547897

Improving academic self-efficacy, school connectedness, and identity in struggling middle school girls: a preliminary study of the REAL girls program.

PubMed

Mann, Michael J; Smith, Megan L; Kristjansson, Alfgeir L

2015-02-01

Girls struggling to be successful in middle school are often dealing with negative life experiences that affect their ability to achieve academically. Frequently, their academic failures and problem behaviors are associated with feeling overwhelmed by difficult and challenging life circumstances. In the absence of intervention, these patterns may contribute to girls chronically underperforming in school, dropping out of school, and becoming involved in delinquent and high-risk behaviors. This article describes a quasi-experimental, mixed-methods study of the REAL Girls program. REAL Girls was designed to help struggling middle school girls develop resilience--particularly academic self-efficacy, school connectedness, and identity--and achieve successful outcomes in school and life. In this study, using a crossover design, 48 girls identified as experiencing academic failure, school behavior problems, or truancy participated in one of two implementations of this 3-day intervention. Findings based on both quantitative and qualitative data suggest that REAL Girls contributed to positive increases in academic self-efficacy, school connectedness, and identity. Repeated measures analysis of variance and paired t tests suggest significant increases in each outcome variable, both immediately after program delivery and 2 weeks later, and effect size estimates suggest moderate to large program impact. Focus groups conducted 90 days after implementation of the program confirmed the quantitative findings and support the efficacy of the REAL Girls program and approach. © 2014 Society for Public Health Education.

A Preliminary Assessment of Silver Nanoparticle Inhibition of Monkeypox Virus Plaque Formation

NASA Astrophysics Data System (ADS)

Rogers, James V.; Parkinson, Christopher V.; Choi, Young W.; Speshock, Janice L.; Hussain, Saber M.

2008-04-01

The use of nanotechnology and nanomaterials in medical research is growing. Silver-containing nanoparticles have previously demonstrated antimicrobial efficacy against bacteria and viral particles. This preliminary study utilized an in vitro approach to evaluate the ability of silver-based nanoparticles to inhibit infectivity of the biological select agent, monkeypox virus (MPV). Nanoparticles (10 80 nm, with or without polysaccharide coating), or silver nitrate (AgNO3) at concentrations of 100, 50, 25, and 12.5 μg/mL were evaluated for efficacy using a plaque reduction assay. Both Ag-PS-25 (polysaccharide-coated, 25 nm) and Ag-NP-55 (non-coated, 55 nm) exhibited a significant ( P ≤ 0.05) dose-dependent effect of test compound concentration on the mean number of plaque-forming units (PFU). All concentrations of silver nitrate (except 100 μg/mL) and Ag-PS-10 promoted significant ( P ≤ 0.05) decreases in the number of observed PFU compared to untreated controls. Some nanoparticle treatments led to increased MPV PFU ranging from 1.04- to 1.8-fold above controls. No cytotoxicity (Vero cell monolayer sloughing) was caused by any test compound, except 100 μg/mL AgNO3. These results demonstrate that silver-based nanoparticles of approximately 10 nm inhibit MPV infection in vitro, supporting their potential use as an anti-viral therapeutic.

May selective serotonin reuptake inhibitors (SSRIs) provide some benefit for the treatment of schizophrenia?

PubMed

Buoli, Massimiliano; Serati, Marta; Ciappolino, Valentina; Altamura, A Carlo

2016-07-01

The treatment of some psychopathological dimensions of schizophrenia (e.g. negative and depressive symptoms) is still challenging for the modest efficacy of atypical antipsychotics. Among pharmacological alternatives, augmentative Selective Serotonin Reuptake Inhibitors (SSRIs) to antipsychotics are frequently prescribed in clinical practice to improve negative/depressive symptoms of schizophrenia patients; however, the data about the efficacy of these molecules on negative, depressive and obsessive-compulsive symptoms of schizophrenia are contrasting. Research using the main database sources has been conducted to obtain an overview of the use and efficacy of SSRIs in schizophrenia. Data are too scanty to draw definitive recommendations. In a preliminary way, it can be said that available data do not show effectiveness of SSRIs on depressive symptoms of schizophrenia. Regarding negative symptoms, studies are contrasting, but paroxetine appears to be the most effective compound among SSRIs. Despite limited data, SSRIs appear to be useful for the treatment of obsessive-compulsive symptoms of schizophrenia, particularly fluvoxamine. Close clinical and pharmacological monitoring is needed in case of concomitant administration of antipsychotics and antidepressants for potential serious side effects and influence on plasma drug dosages.

First-in-Human Phase 1 Trial of Agarose Beads Containing Murine RENCA Cells in Advanced Solid Tumors.

PubMed

Smith, Barry H; Parikh, Tapan; Andrada, Zoe P; Fahey, Thomas J; Berman, Nathaniel; Wiles, Madeline; Nazarian, Angelica; Thomas, Joanne; Arreglado, Anna; Akahoho, Eugene; Wolf, David J; Levine, Daniel M; Parker, Thomas S; Gazda, Lawrence S; Ocean, Allyson J

2016-01-01

Agarose macrobeads containing mouse renal adenocarcinoma cells (RMBs) release factors, suppressing the growth of cancer cells and prolonging survival in spontaneous or induced tumor animals, mediated, in part, by increased levels of myocyte-enhancing factor (MEF2D) via EGFR-and AKT-signaling pathways. The primary objective of this study was to determine the safety of RMBs in advanced, treatment-resistant metastatic cancers, and then its efficacy (survival), which is the secondary objective. Thirty-one patients underwent up to four intraperitoneal implantations of RMBs (8 or 16 macrobeads/kg) via laparoscopy in this single-arm trial (FDA BB-IND 10091; NCT 00283075). Serial physical examinations, laboratory testing, and PET-CT imaging were performed before and three months after each implant. RMBs were well tolerated at both dose levels (mean 660.9 per implant). AEs were (Grade 1/2) with no treatment-related SAEs. The data support the safety of RMB therapy in advanced-malignancy patients, and the preliminary evidence for their potential efficacy is encouraging. A Phase 2 efficacy trial is ongoing.

A study to compare the efficacy of corticosteroid therapy with platelet-rich plasma therapy in recalcitrant plantar fasciitis: a preliminary report.

PubMed

Shetty, Vijay D; Dhillon, Mandeep; Hegde, Chintan; Jagtap, Prajyot; Shetty, Suvin

2014-03-01

Plantar fasciitis is one of the commonest, and most frustrating, foot ailments seen in a regular orthopaedic clinic. There are a number of modalities available to treat this condition, of which corticosteroid injection is, perhaps, the most popular. However, recent years have seen an increased interest in the use of platelet-rich plasma (PRP) injections in various clinical situations such as plantar fasciitis. We undertook a prospective non-randomized study to compare the efficacy of traditional corticosteroid injection (Steroid group) to PRP injection (PRP group), in a cohort of patients. We studied both groups of patients before and after the injections using Visual Analogue Score (VAS), the Foot & Ankle Disability Index (FADI) and American Foot and Ankle Score (AFAS). Our study confirms that there is significant clinical improvement in PRP group at three months after the injection. The use of PRP injection can be an attractive alternative in the treatment of disabling, recalcitrant plantar fasciitis. Cohort study. Level 3. Copyright © 2013 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.

Aerobic Exercise for Alcohol Recovery: Rationale, Program Description, and Preliminary Findings

ERIC Educational Resources Information Center

Brown, Richard A.; Abrantes, Ana M.; Read, Jennifer P.; Marcus, Bess H.; Jakicic, John; Strong, David R.; Oakley, Julie R.; Ramsey, Susan E.; Kahler, Christopher W.; Stuart, Gregory; Dubreuil, Mary Ella; Gordon, Alan A.

2009-01-01

Alcohol use disorders are a major public health concern. Despite the demonstrated efficacy of a number of different treatments for alcohol dependence, relapse remains a major problem. Healthy lifestyle changes may contribute to long-term maintenance of recovery, and interventions targeting physical activity, in particular, may be especially…

Assessing and Treating Child Anxiety in Schools

ERIC Educational Resources Information Center

Mychailyszyn, Matthew P.; Beidas, Rinad S.; Benjamin, Courtney L.; Edmunds, Julie M.; Podell, Jennifer L.; Cohen, Jeremy S.; Kendall, Philip C.

2011-01-01

Anxiety disorders in youth are common and, if left untreated, can lead to a variety of negative sequelae. Randomized clinical trials have demonstrated that cognitive-behavioral therapy (CBT) is an efficacious treatment for anxiety disorders in youth with preliminary evidence showing that CBT can be successfully transported into schools. The…

Computerized cognitive training in prostate cancer patients on androgen deprivation therapy: a pilot study.

PubMed

Wu, Lisa M; Amidi, Ali; Tanenbaum, Molly L; Winkel, Gary; Gordon, Wayne A; Hall, Simon J; Bovbjerg, Katrin; Diefenbach, Michael A

2018-06-01

Prostate cancer patients who have undergone androgen deprivation therapy (ADT) may experience cognitive impairment, yet there is an unmet need for nonpharmacological interventions to address cognitive impairment in this population. This study examines the feasibility, acceptability, and preliminary efficacy of a home-based computerized cognitive training (CCT) program to treat cancer-related cognitive impairment. Sixty men who had received ≥ 3 months of ADT were screened for at least mild cognitive or neurobehavioral impairment and randomized to 8 weeks of CCT or usual care. Follow-up assessments occurred immediately post-intervention or equivalent (T2) and 8 weeks later (T3). The acceptability of CCT was also assessed. Feasibility:A priori feasibility thresholds were partially met (i.e., randomization rate > 50%, retention rate > 70% excluding CCT drop-outs, but < 70% for intent-to-treat). Acceptability: Participants were mostly satisfied with CCT and found it somewhat enjoyable, though barriers to uptake existed. Preliminary efficacy: Linear mixed models indicated significant time by group effects favorable to CCT in reaction time (p = .01), but unfavorable to CCT in verbal and visual memory (ps < .05). Memory was temporarily suppressed in the CCT group at T2, but normalized by T3. There was no effect of CCT on self-reported cognitive functioning, neurobehavioral functioning, nor quality of life. This study provides tentative support for the feasibility and acceptability of CCT to treat mild cognitive impairment in ADT patients. CCT had a beneficial effect on reaction time, but temporarily suppressed memory. CCT's benefits may be limited to a narrow area of functioning. Larger-scale studies are needed.

Transcutaneous supraorbital neurostimulation for the prevention of chronic migraine: a prospective, open-label preliminary trial.

PubMed

Di Fiore, Paola; Bussone, Gennaro; Galli, Alberto; Didier, Henri; Peccarisi, Cesare; D'Amico, Domenico; Frediani, Fabio

2017-05-01

Since chronic migraine is difficult to treat and often associated with medication overuse, non-invasive neurostimulation approaches are worth investigating. Transcutaneous supraorbital neurostimulation using the Cefaly ® device is promising as a non-invasive preventive treatment for episodic migraine, but no data are available for chronic migraine. Our aim was to perform a preliminary evaluation of the efficacy of the Cefaly ® device for the prophylaxis of chronic migraine with or without medication overuse. Primary endpoints were 50% reduction in monthly migraine days and 50% reduction in monthly medication use over 4 months. In an open-label study, twenty-three consecutive headache center patients with chronic migraine, diagnosed according to International Headache Society criteria, were recruited prospectively. After informed consent, patients were trained to use Cefaly ® and instructed to use it for 20 min daily over 4 months. All patients received active neurostimulation. Thirty-five percent of the patients enrolled in the study achieved the study endpoints. Over half the patients had a greater than 50% reduction in acute medication consumption.

Acamprosate and Baclofen were Not Effective in the Treatment of Pathological Gambling: Preliminary Blind Rater Comparison Study.

PubMed

Dannon, Pinhas N; Rosenberg, Oded; Schoenfeld, Netta; Kotler, Moshe

2011-01-01

Pathological gambling (PG) is a highly prevalent and disabling impulse control disorder. A range of psychopharmacological options are available for the treatment of PG, including selective serotonin reuptake inhibitors, opioid receptor antagonists, anti-addiction drugs, and mood stabilizers. In our preliminary study, we examined the efficacy of two anti-addiction drugs, baclofen and acamprosate, in the treatment of PG. Seventeen male gamblers were randomly divided into two groups. Each group received one of the two drugs without being blind to treatment. All patients underwent a comprehensive psychiatric diagnostic evaluation and completed a series of semi-structured interviews. During the 6-months of study, monthly evaluations were carried out to assess improvement and relapses. Relapse was defined as recurrent gambling behavior. None of the 17 patients reached the 6-months abstinence. One patient receiving baclofen sustained abstinence for 4 months. Fourteen patients succeeded in sustaining abstinence for 1-3 months. Two patients stopped attending monthly evaluations. Baclofen and acamprosate did not prove efficient in treating pathological gamblers.

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

PubMed

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

2012-01-01

Curcumin is a polyphenolic compound derived from the plant Curcuma Long Lin that has been demonstrated to have antioxidant and anti-inflammatory effects as well as effects on reducing beta-amyloid aggregation. It reduces pathology in transgenic models of Alzheimer's disease (AD) and is a promising candidate for treating human AD. The purpose of the current study is to generate tolerability and preliminary clinical and biomarker efficacy data on curcumin in persons with AD. We performed a 24-week randomized, double blind, placebo-controlled study of Curcumin C3 Complex(®) with an open-label extension to 48 weeks. Thirty-six persons with mild-to-moderate AD were randomized to receive placebo, 2 grams/day, or 4 grams/day of oral curcumin for 24 weeks. For weeks 24 through 48, subjects that were receiving curcumin continued with the same dose, while subjects previously receiving placebo were randomized in a 1:1 ratio to 2 grams/day or 4 grams/day. The primary outcome measures were incidence of adverse events, changes in clinical laboratory tests and the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) at 24 weeks in those completing the study. Secondary outcome measures included the Neuropsychiatric Inventory (NPI), the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) scale, levels of Aβ1-40 and Aβ1-42 in plasma and levels of Aβ1-42, t-tau, p-tau181 and F2-isoprostanes in cerebrospinal fluid. Plasma levels of curcumin and its metabolites up to four hours after drug administration were also measured. Mean age of completers (n = 30) was 73.5 years and mean Mini-Mental Status Examination (MMSE) score was 22.5. One subject withdrew in the placebo (8%, worsened memory) and 5/24 subjects withdrew in the curcumin group (21%, 3 due to gastrointestinal symptoms). Curcumin C3 Complex(®) was associated with lowered hematocrit and increased glucose levels that were clinically insignificant. There were no differences between treatment groups in clinical or biomarker efficacy measures. The levels of native curcumin measured in plasma were low (7.32 ng/mL). Curcumin was generally well-tolerated although three subjects on curcumin withdrew due to gastrointestinal symptoms. We were unable to demonstrate clinical or biochemical evidence of efficacy of Curcumin C3 Complex(®) in AD in this 24-week placebo-controlled trial although preliminary data suggest limited bioavailability of this compound. ClinicalTrials.gov Identifier: NCT00099710.

Pharmacokinetics of Intranasal Scopolamine Gel Formulation (Inscop)

NASA Technical Reports Server (NTRS)

Boyd, Jason L.; Du, Brian; Daniels, Vernie; Simmons, Rita; Buckey, Jay; Putcha, Lakshmi

2009-01-01

Space Motion Sickness (SMS) is commonly experienced by astronauts and often requires treatment with medications during early flight days of space missions. Orally administered scopolamine is commonly used by astronauts to prevent SMS. Bioavailability of oral (PO) SMS medications is often low and highly variable. Intranasal (IN) administration of medications achieves higher and more reliable bioavailability than from an equivalent PO dose. Methods: To test the safety and reliability of INSCOP, two clinical studies were performed, a dose escalation study and a comparison study administering INSCOP during normal ambulation and head down tilt bedrest. Efficacy was evaluated by testing INSCOP with two, different motion sickness inducing paradigms. Results: Preliminary results indicate that INSCOP demonstrates linear pharmacokinetics and a low side effect profile. In head down tilt bedrest, relative bioavailability of INSCOP was increased for females at both doses (0.2 and 0.4 mg) and for males at the higher dose (0.4 mg) but is reduced at the lower dose (0.2 mg) compared to normal ambulation. INSCOP displays gender specific differences during ABR. One of the treatment efficacy trials conducted at Dartmouth Hitchcock Medical Center demonstrated that INSCOP is efficacious at both doses (0.2 and 0.4 mg) in suppressing motion sickness symptoms as indicated by longer chair ride times with INSCOP administration than with placebo, and efficacy increases with dose. Similar results were seen using another motion sickness simulator, the motion simulator dome, at the Naval Aerospace Medical Research Laboratory, with significantly increased time in the dome in motion-susceptible subjects when using INSCOP compared to untreated controls. Conclusion: Higher bioavailability, linear pharmacokinetics, a low incidence of side effects, and a favorable efficacy profile make INSCOP a desirable formulation for prophylactic and rescue treatment of astronauts in space and military personnel on duty.

Efficacy of botulinum toxin in treating myofascial pain in bruxers: a controlled placebo pilot study.

PubMed

Guarda-Nardini, Luca; Manfredini, Daniele; Salamone, Milena; Salmaso, Luigi; Tonello, Stefano; Ferronato, Giuseppe

2008-04-01

The present investigation is a preliminary double-blind, controlled placebo, randomized clinical trial with a six month follow-up period. The study aimed to assess the efficacy of type A botulinum toxin (Botox, Allergan, Inc. Irvine, CA) to treat myofascial pain symptoms and to reduce muscle hyperactivity in bruxers. Twenty patients (ten males, ten females; age range 25-45) with a clinical diagnosis of bruxism and myofascial pain of the masticatory muscles were enrolled in a double-blind, controlled placebo, randomized clinical trial, with a treatment group (ten subjects treated with botulinum toxin injections- BTX-A) and a control group (ten subjects treated with saline placebo injections). A number of objective and subjective clinical parameters (pain at rest and during chewing; mastication efficiency; maximum nonassisted and assisted mouth opening, protrusive and laterotrusive movements; functional limitation during usual jaw movements; subjective efficacy of the treatment; tolerance of the treatment) were assessed at baseline time and at one week, one month, and six months follow-up appointments. Descriptive analysis showed that improvements in both objective (range of mandibular movements) and subjective (pain at rest; pain during chewing) clinical outcome variables were higher in the Botox treated group than in the placebo treated subjects. Patients treated with BTX-A had a higher subjective improvement in their perception of treatment efficacy than the placebo subjects. Differences were not significant in some cases due to the small sample size. Results from the present study supported the efficacy of BTX-A to reduce myofascial pain symptoms in bruxers, and provided pilot data which need to be confirmed by further research using larger samples.

Mind-body treatments for the pain-fatigue-sleep disturbance symptom cluster in persons with cancer.

PubMed

Kwekkeboom, Kristine L; Cherwin, Catherine H; Lee, Jun W; Wanta, Britt

2010-01-01

Co-occurring pain, fatigue, and sleep disturbance comprise a common symptom cluster in patients with cancer. Treatment approaches that target the cluster of symptoms rather than just a single symptom need to be identified and tested. To synthesize evidence regarding mind-body interventions that have shown efficacy in treating two or more symptoms in the pain-fatigue-sleep disturbance cancer symptom cluster. A literature search was conducted using CINAHL, Medline, and PsychInfo databases through March 2009. Studies were categorized based on the type of mind-body intervention (relaxation, imagery/hypnosis, cognitive-behavioral therapy/coping skills training [CBT/CST], meditation, music, and virtual reality), and a preliminary review was conducted with respect to efficacy for pain, fatigue, and sleep disturbance. Mind-body interventions were selected for review if there was evidence of efficacy for at least two of the three symptoms. Forty-three studies addressing five types of mind-body interventions met criteria and are summarized in this review. Imagery/hypnosis and CBT/CST interventions have produced improvement in all the three cancer-related symptoms individually: pain, fatigue, and sleep disturbance. Relaxation has resulted in improvements in pain and sleep disturbance. Meditation interventions have demonstrated beneficial effects on fatigue and sleep disturbance. Music interventions have demonstrated efficacy for pain and fatigue. No trials were found that tested the mind-body interventions specifically for the pain-fatigue-sleep disturbance symptom cluster. Efficacy studies are needed to test the impact of relaxation, imagery/hypnosis, CBT/CST, meditation, and music interventions in persons with cancer experiencing concurrent pain, fatigue, and sleep disturbance. These mind-body interventions could help patients manage all the symptoms in the cluster with a single treatment strategy. Copyright 2010 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

Efficacy of Tribulus Terrestris Extract on the Serum Glucose and Lipids of Women with Diabetes Mellitus.

PubMed

Samani, Nasrin Babadai; Jokar, Azam; Soveid, Mahmood; Heydari, Mojtaba; Mosavat, Seyed Hamdollah

2016-05-01

Considering folkloric use of Tribulus terrestris (T. terrestris) in diabetes and proven anti-hyperglycemic and anti-hyperlipidemic effects of T. terrestris in animal studies, we aimed to evaluate the efficacy of the hydro alcoholic extract of T. terrestris on the serum glucose and lipid profile of women with diabetes mellitus. Ninety-eight diabetic women were randomly allocated to receive the T. terrestris (1000 mg/day) or placebo for three months. The patients were evaluated in terms of the fasting blood glucose, 2-hour postprandial glucose, glycosylated hemoglobin and lipid profile. T. terrestris showed a significant blood glucose lowering effect in diabetic women compared to placebo (P<0.05). Also, the total cholesterol and low-density lipoprotein of the T. terrestris group was significantly reduced compared with placebo, while no significant effect was observed in the triglyceride and high-density lipoprotein levels. This study showed preliminary promising hypoglycemic effect of T. terrestris in diabetic women.

Efficacy of Tribulus Terrestris Extract on the Serum Glucose and Lipids of Women with Diabetes Mellitus

PubMed Central

Samani, Nasrin Babadai; Jokar, Azam; Soveid, Mahmood; Heydari, Mojtaba; Mosavat, Seyed Hamdollah

2016-01-01

Background: Considering folkloric use of Tribulus terrestris (T. terrestris) in diabetes and proven anti-hyperglycemic and anti-hyperlipidemic effects of T. terrestris in animal studies, we aimed to evaluate the efficacy of the hydro alcoholic extract of T. terrestris on the serum glucose and lipid profile of women with diabetes mellitus. Methods: Ninety-eight diabetic women were randomly allocated to receive the T. terrestris (1000 mg/day) or placebo for three months. The patients were evaluated in terms of the fasting blood glucose, 2-hour postprandial glucose, glycosylated hemoglobin and lipid profile. Results: T. terrestris showed a significant blood glucose lowering effect in diabetic women compared to placebo (P<0.05). Also, the total cholesterol and low-density lipoprotein of the T. terrestris group was significantly reduced compared with placebo, while no significant effect was observed in the triglyceride and high-density lipoprotein levels. Conclusion: This study showed preliminary promising hypoglycemic effect of T. terrestris in diabetic women. PMID:27840471

Efficacy of Tribulus Terrestris Extract on the Serum Glucose and Lipids of Women with Diabetes Mellitus

PubMed Central

Samani, Nasrin Babadai; Jokar, Azam; Soveid, Mahmood; Heydari, Mojtaba; Mosavat, Seyed Hamdollah

2016-01-01

Background: Considering folkloric use of Tribulus terrestris (T. terrestris) in diabetes and proven anti-hyperglycemic and anti-hyperlipidemic effects of T. terrestris in animal studies, we aimed to evaluate the efficacy of the hydro alcoholic extract of T. terrestris on the serum glucose and lipid profile of women with diabetes mellitus. Methods: Ninety-eight diabetic women were randomly allocated to receive the T. terrestris (1000 mg/day) or placebo for three months. The patients were evaluated in terms of the fasting blood glucose, 2-hour postprandial glucose, glycosylated hemoglobin and lipid profile. Results: T. terrestris showed a significant blood glucose lowering effect in diabetic women compared to placebo (P<0.05). Also, the total cholesterol and low-density lipoprotein of the T. terrestris group was significantly reduced compared with placebo, while no significant effect was observed in the triglyceride and high-density lipoprotein levels. Conclusion: This study showed preliminary promising hypoglycemic effect of T. terrestris in diabetic women. PMID:27516681

Treatment of psoriatic nails with indigo naturalis oil extract: a non-controlled pilot study.

PubMed

Lin, Yin-Ku; See, Lai-Chu; Chang, Ya-Ching; Huang, Yu-Huei; Chen, Jiun-Liang; Tsou, Teng-Cheng; Leu, Yann-Lii; Shen, Yu-Ming

2011-01-01

In the treatment of nail psoriasis, standardized therapeutic regimens are currently lacking. To evaluate the therapeutic efficacy of indigo naturalis oil extract in patients with nail psoriasis. Patients with nail psoriasis applied indigo naturalis oil extract on affected nails twice daily for 24 weeks. Efficacy was evaluated using the Nail Psoriasis Severity Index (NAPSI) and modified target NAPSI for the single most severely affected nail. Twenty-eight out of 32 patients completed the study. The mean NAPSI was 36.1 ± 14.7 at baseline and decreased to 14.9 ± 11.1 at week 24 while the mean modified target NAPSI was 11.7 ± 3.9 at baseline and decreased to 3.6 ± 3.2 at week 24. Indigo naturalis oil extract appeared to improve nail psoriasis. Although preliminary, these results indicate that it could provide a novel therapeutic option for nail psoriasis, a disease notoriously difficult to treat. Copyright © 2011 S. Karger AG, Basel.

Herbal Dietary Supplements for Erectile Dysfunction: A Systematic Review and Meta-Analysis.

PubMed

Borrelli, Francesca; Colalto, Cristiano; Delfino, Domenico V; Iriti, Marcello; Izzo, Angelo A

2018-04-01

Erectile dysfunction (ED) is a common condition that significantly affects quality of life and interpersonal relationships. Our objective was to perform a systematic review and meta-analysis to evaluate the efficacy of herbal dietary supplements in the treatment of ED. We searched five databases to identify randomized controlled trials (RCTs) that evaluated the clinical efficacy of herbal medicines in ED. Quality was assessed and risk of bias was estimated using the Jadad score and the Cochrane risk-of-bias tool. In total, 24 RCTs, including 2080 patients with ED, were identified. Among these, 12 evaluated monopreparations (five ginseng [n = 399], three saffron [n = 397], two Tribulus terrestris [n = 202], and one each Pinus pinaster [n = 21] and Lepidium meyenii [n = 50]), seven evaluated formulations (n = 544), and five investigated dietary supplements in combination with pure compounds (n = 410). Ginseng significantly improved erectile function (International Index of Erectile Function [IIEF]-5 score: 140 ginseng, 96 placebo; standardized mean difference [SMD] 0.43; 95% confidence interval [CI] 0.15-0.70; P < 0.01; I 2  = 0), P. pinaster and L. meyenii showed very preliminary positive results, and saffron and T. terrestris treatment produced mixed results. Several herbal formulations were associated with a decrease of IIEF-5 or IIEF-15, although the results were preliminary. The quality of the included studies varied, with only seven having a prevalent low risk of bias. The median methodological quality Jadad score was three out of a maximum of five. Adverse events were recorded in 19 of 24 trials, with no significant differences between placebo and verum in placebo-controlled studies. Encouraging evidence suggests that ginseng may be an effective herbal treatment for ED. However, further, larger, and high-quality studies are required before firm conclusions can be drawn. Promising (although very preliminary) results have also been generated for some herbal formulations. Overall, more research in the field, adhering to the CONSORT statement extension for reporting trials, is justified before the use of herbal products in ED can be recommended.

Feasibility, Acceptability, and Initial Efficacy of a Knowledge-Contact Program to Reduce Mental Illness Stigma and Improve Mental Health Literacy in Adolescents

PubMed Central

Pinto-Foltz, Melissa D.; Logsdon, M. Cynthia; Myers, John A.

2011-01-01

The purpose of this school-based cluster-randomized trial was to determine the initial acceptability, feasibility, and efficacy of an existing community-based intervention, In Our Own Voice, in a sample of US adolescent girls aged 13–17 years (n=156). In Our Own Voice is a knowledge-contact intervention that provides knowledge about mental illness to improve mental health literacy and facilitates intergroup contact with persons with mental illness as a means to reduce mental illness stigma. This longitudinal study was set in two public high schools located in a southern urban community of the U.S. Outcomes included measures of mental illness stigma and mental health literacy. Findings support the acceptability and feasibility of the intervention for adolescents who enrolled in the study. Findings to support the efficacy of In Our Own Voice to reduce stigma and improve mental health literacy are mixed. The intervention did not reduce mental illness stigma or improve mental health literacy at one week follow up. The intervention did not reduce mental illness stigma at 4 and 8 weeks follow up. The intervention did improve mental health literacy at 4 and 8 weeks follow up. Previous studies have assessed the preliminary efficacy In Our Own Voice among young adults; rarely has In Our Own Voice been investigated longitudinally and with adolescents in the United States. This study provides initial data on the effects of In Our Own Voice for this population and can be used to further adapt the intervention for adolescents. PMID:21624729

Dexamethasone mimicks the antimotion sickness effects of amphetamine and scopolamine

NASA Astrophysics Data System (ADS)

Kohl, Randall Lee

Based on preliminary suggestions that individual differences in susceptibility to stressful motion might be related to physiological differences in responses of the hypothalamic-pituitary-adrenal axis, we tested the efficacy of dexamethasone and metyrapone in subjects exposed to cross-coupled accelerative semicircular canal stimulation on a rotating chair. Subjects given 0.5 mg of dexamethasone every 6 h for 48 h could endure 80% more stressful motion ( P = 0.03) in a within-subjects design study, whereas, no improvement followed treatment with 750 mg of metryapone every 4 h for 24 h. The efficacy of dexamethasone might be explained in terms of its neurochemical actions on several neurotransmitter systems which are also modulated by such classical antimotion sickness drugs as amphetamine and scopolamine. Because dexamethasone induces adaptive changes within the central nervous system it may prove superior to scopolamine and amphetamine which possess significant side effects, are short acting, and rapidly tolerated.

Behavioural laterality as a factor in emotional regulation.

PubMed

Rempala, Daniel M

2014-01-01

Individuals who perform a variety of tasks using one side of their bodies (i.e., high-dominance people) are thought to differ from individuals who perform a variety of tasks with both sides of their body (i.e., low-dominance people) in several neurological and cognitive characteristics. We examined whether behavioural laterality predicted the efficacy of different emotional regulation strategies. Specifically, we thought that behavioural laterality would influence verbal strategies (associated with left hemisphere activation) when regulating anxiety (associated with right hemisphere activation). In three studies participants presented in front of small audiences. Behavioural laterality (as measured by a modified handedness inventory) positively correlated with presentation anxiety, such that "low-dominance" participants reported less anxiety than "high-dominance" participants, but only when using cognitive reappraisal (a verbal strategy), not attention deployment or response modulation (behavioural strategies). These results provide preliminary evidence that individual differences in behavioural laterality mediate the efficacy of certain emotional regulation strategies.

Omega-3 Fatty Acid and Nutrient Deficits in Adverse Neurodevelopment and Childhood Behaviors

PubMed Central

Hibbeln, Joseph. R.; Gow, Rachel V.

2014-01-01

Synopsis Nutritional insufficiencies of omega-3 highly unsaturated fatty acids (HUFAs) may have adverse effects on brain development and neurodevelopmental outcomes. A recent meta-analysis of ten randomized controlled trials of omega-3 HUFAs reported a small to modest effect size for the efficacy of omega-3 for treating symptoms of ADHD in youth. Several controlled trials of omega-3 HUFAs combined with micronutrients (vitamins, minerals) show sizeable reductions in aggressive, antisocial, and violent behavior in youth and in young adult prisoners. Meta-analyses report efficacy for depressive symptoms in adults, and preliminary findings suggest anti-suicidal properties in adults, but studies in youth are insufficient to draw any conclusions regarding mood. Dietary adjustments to increase omega-3 and reduce omega-6 HUFA consumption are sensible recommendations for youth and adults based on general health considerations, while the evidence base for omega-3 HUFAs as potential psychiatric treatments develops. PMID:24975625

Dexamethasone mimicks the antimotion sickness effects of amphetamine and scopolamine

NASA Technical Reports Server (NTRS)

Kohl, Randall Lee

1986-01-01

Based on preliminary suggestions that individual differences in susceptibility to stressful motion might be related to physiological differences in responses of the hypothalamic-pituitary-adrenal axis, the efficacy of dexamethasone and metyrapone is tested in subjects exposed to cross-coupled accelerative semicircular canal stimulation on a rotating chair. Subjects given 0.5 mg of dexamethasone every 6 h for 48 h could endure 80 percent more stressful motion (P = 0.03) in a within-subjects design study, whereas, no improvement followed treatment with 750 mg of metryapone every 4 h for 24 h. The efficacy of dexamethasone might be explained in terms of its neurochemical actions on several neurotransmitter systems which are also modulated by such classical antimotion sickness drugs as amphetamine and scopolamine. Because dexamethasone induces adaptive changes within the central nervous system it may prove superior to scopolamine and amphetamine which possess significant side effects, are short acting, and rapidly tolerated.

PLGA-Curcumin Attenuates Opioid-Induced Hyperalgesia and Inhibits Spinal CaMKIIα

PubMed Central

Hu, Xiaoyu; Huang, Fang; Szymusiak, Magdalena; Tian, Xuebi; Liu, Ying; Wang, Zaijie Jim

2016-01-01

Opioid-induced hyperalgesia (OIH) is one of the major problems associated with prolonged use of opioids for the treatment of chronic pain. Effective treatment for OIH is lacking. In this study, we examined the efficacy and preliminary mechanism of curcumin in attenuating OIH. We employed a newly developed PLGA-curcumin nanoformulation (PLGA-curcumin) in order to improve the solubility of curcumin, which has been a major obstacle in properly characterizing curcumin’s mechanism of action and efficacy. We found that curcumin administered intrathecally or orally significantly attenuated hyperalgesia in mice with morphine-induced OIH. Furthermore, we demonstrated that the effects of curcumin on OIH correlated with the suppression of chronic morphine-induced CaMKIIα activation in the superficial laminae of the spinal dorsal horn. These data suggest that PLGA-curcumin may reverse OIH possibly by inhibiting CaMKIIα and its downstream signaling. PMID:26744842

A Randomized, Crossover Trial of a Novel Sound-to-Sleep Mattress Technology in Children with Autism and Sleep Difficulties.

PubMed

Frazier, Thomas W; Krishna, Jyoti; Klingemier, Eric; Beukemann, Mary; Nawabit, Rawan; Ibrahim, Sally

2017-01-15

This preliminary study investigated the tolerability and efficacy of a novel mattress technology-the Sound-To-Sleep (STS) system-in the treatment of sleep problems in children with autism. After screening, 45 children, ages 2.5 to 12.9 years, were randomized to order of mattress technology use (On-Off vs. Off-On). Treatment conditions (On vs. Off) lasted two weeks with immediate crossover. Tolerability, including study discontinuation and parent-report of mattress tolerance and ease of use, was tracked throughout the study. Efficacy assessments were obtained at baseline, prior to crossover, and end of study and included measures of autism traits, other psychopathology symptoms, sensory abnormalities, communication difficulties, quality of life, sleep diary parameters, and single-blinded actigraphy-derived sleep parameters. Statistical analyses evaluated differences in tolerability and efficacy when the STS system was on versus off. STS system use was well tolerated (n = 2, 4.4% dropout) and resulted in parent-reported sleep quality improvements (STS off mean = 4.3, 95% CI = 4.05-4.54 vs. on mean = 4.9, 95%CI = 4.67-5.14). The technology was described by parents as very easy to use and child tolerance was rated as good. Parent-diary outcomes indicated improvements in falling asleep and reduced daytime challenging behavior. Actigraphy-derived sleep parameters indicated improved sleep duration and sleep efficiency. Improvements in child and family quality of life were identified on parent questionnaires. A future large sample phase 2 trial of the STS system is warranted and would benefit from extended study duration, an objective primary efficacy outcome, and careful attention to methodological issues that promote compliance with the intervention and study procedures. © 2017 American Academy of Sleep Medicine

Modified prepubic TVT-obturator tape procedure versus the conventional method: a preliminary study.

PubMed

Long, Cheng-Yu; Wu, Ming-Ping; Wang, Chiu-Lin; Lin, Kun-Ling; Liu, Cheng-Min; Wu, Shu-Hui; Juan, Yung-Shun

2013-12-01

To compare the efficacy and safety of the modified prepubic tension-free vaginal tape-obturator (PTVT-O) system procedure with the original TVT-O methods. One hundred and ninety women with urodynamic stress incontinence (USI) were included in this study (93 cases in the TVT-O group and 97 in the PTVT-O group). Clinical assessments before and one year after surgery included urinalyses, 1-h pad tests, urodynamic studies, and a personal interview with the overactive bladder symptom score (OABSS) questionnaire. There were no differences between the two groups in mean age, parity, menopausal status, mean operative time and subjective cure rates (P>0.05), but the efficacy of surgery (cure and improvement) in the PTVT-O group was significantly higher than that in the TVT-O group (P=0.038). Complication rates and visual analog scale (VAS) scores were found to be similar (P>0.05). OABSS decreased significantly after surgery in both groups (P<0.05) although all urodynamic parameters revealed no significant difference after both procedures (P>0.05). Our modified procedure is a safe and effective treatment for female USI. It has an advantage over the original TVT-O with better surgical efficacy and comparable postoperative pain, although the follow-up times in this study are different. Copyright © 2013. Published by Elsevier Ireland Ltd.

Enhancing computer self-efficacy and attitudes in multi-ethnic older adults: a randomised controlled study

PubMed Central

Laganà, Luciana; Oliver, Taylor; Ainsworth, Andrew; Edwards, Marc

2014-01-01

Several studies have documented the health-related benefits of older adults' use of computer technology, but before they can be realised, older individuals must be positively inclined and confident in their ability to engage in computer-based environments. To facilitate the assessment of computer technology attitudes, one aim of the longitudinal study reported in this paper was to test and refine a new 22-item measure of computer technology attitudes designed specifically for older adults, as none such were available.1 Another aim was to replicate, on a much larger scale, the successful findings of a preliminary study that tested a computer technology training programme for older adults (Laganà 2008). Ninety-six older men and women, mainly from non-European-American backgrounds, were randomly assigned to the waitlist/control or the experimental group. The same six-week one-on-one training was administered to the control subjects at the completion of their post-test. The revised (17-item) version of the Older Adults' Computer Technology Attitudes Scale (OACTAS) showed strong reliability: the results of a factor analysis were robust, and two analyses of covariance demonstrated that the training programme induced significant changes in attitudes and self-efficacy. Such results encourage the recruitment of older persons into training programmes aimed at increasing computer technology attitudes and self-efficacy. PMID:25512679

Subthalamic Nucleus Deep Brain Stimulation in Early Stage Parkinson’s Disease

PubMed Central

Charles, David; Konrad, Peter E.; Neimat, Joseph S.; Molinari, Anna L.; Tramontana, Michael G.; Finder, Stuart G.; Gill, Chandler E.; Bliton, Mark J.; Kao, Chris C.; Phibbs, Fenna T.; Hedera, Peter; Salomon, Ronald M.; Cannard, Kevin R.; Wang, Lily; Song, Yanna; Davis, Thomas L.

2014-01-01

Background Deep brain stimulation (DBS) is an effective and approved therapy for advanced Parkinson’s disease (PD), and a recent study suggests efficacy in mid-stage disease. This manuscript reports the results of a pilot trial investigating preliminary safety and tolerability of DBS in early PD. Methods Thirty subjects with idiopathic PD (Hoehn & Yahr Stage II off medication), age 50–75, on medication ≥ 6 months but < 4 years, and without motor fluctuations or dyskinesias were randomized to optimal drug therapy (ODT) (n=15) or DBS+ODT (n=15). Co-primary endpoints were the time to reach a 4-point worsening from baseline in the UPDRS-III off therapy and the change in levodopa equivalent daily dose from baseline to 24 months. Results As hypothesized, the mean UPDRS total and part III scores were not significantly different on or off therapy at 24 months. The DBS+ODT group took less medication at all time points, and this reached maximum difference at 18 months. With a few exceptions, differences in neuropsychological functioning were not significant. Two subjects in the DBS+ODT group suffered serious adverse events; remaining adverse events were mild or transient. Conclusions This study demonstrates that subjects with early stage PD will enroll in and complete trials testing invasive therapies and provides preliminary evidence that DBS is well tolerated in early PD. The results of this trial provide the data necessary to design a large, phase III, double-blind, multicenter trial investigating the safety and efficacy of DBS in early PD. PMID:24768120

Subthalamic nucleus deep brain stimulation in early stage Parkinson's disease.

PubMed

Charles, David; Konrad, Peter E; Neimat, Joseph S; Molinari, Anna L; Tramontana, Michael G; Finder, Stuart G; Gill, Chandler E; Bliton, Mark J; Kao, Chris; Phibbs, Fenna T; Hedera, Peter; Salomon, Ronald M; Cannard, Kevin R; Wang, Lily; Song, Yanna; Davis, Thomas L

2014-07-01

Deep brain stimulation (DBS) is an effective and approved therapy for advanced Parkinson's disease (PD), and a recent study suggests efficacy in mid-stage disease. This manuscript reports the results of a pilot trial investigating preliminary safety and tolerability of DBS in early PD. Thirty subjects with idiopathic PD (Hoehn & Yahr Stage II off medication), age 50-75, on medication ≥6 months but ≤4 years, and without motor fluctuations or dyskinesias were randomized to optimal drug therapy (ODT) (n = 15) or DBS + ODT (n = 15). Co-primary endpoints were the time to reach a 4-point worsening from baseline in the UPDRS-III off therapy and the change in levodopa equivalent daily dose from baseline to 24 months. As hypothesized, the mean UPDRS total and part III scores were not significantly different on or off therapy at 24 months. Medication requirements in the DBS + ODT group were lower at all time points with a maximal difference at 18 months. With a few exceptions, differences in neuropsychological functioning were not significant. Two subjects in the DBS + ODT group suffered serious adverse events; remaining adverse events were mild or transient. This study demonstrates that subjects with early stage PD will enroll in and complete trials testing invasive therapies and provides preliminary evidence that DBS is well tolerated in early PD. The results of this trial provide the data necessary to design a large, phase III, double-blind, multicenter trial investigating the safety and efficacy of DBS in early PD. Copyright © 2014 Elsevier Ltd. All rights reserved.

Feasibility and Preliminary Efficacy of Visual Cue Training to Improve Adaptability of Walking after Stroke: Multi-Centre, Single-Blind Randomised Control Pilot Trial.

PubMed

Hollands, Kristen L; Pelton, Trudy A; Wimperis, Andrew; Whitham, Diane; Tan, Wei; Jowett, Sue; Sackley, Catherine M; Wing, Alan M; Tyson, Sarah F; Mathias, Jonathan; Hensman, Marianne; van Vliet, Paulette M

2015-01-01

Given the importance of vision in the control of walking and evidence indicating varied practice of walking improves mobility outcomes, this study sought to examine the feasibility and preliminary efficacy of varied walking practice in response to visual cues, for the rehabilitation of walking following stroke. This 3 arm parallel, multi-centre, assessor blind, randomised control trial was conducted within outpatient neurorehabilitation services. Community dwelling stroke survivors with walking speed <0.8m/s, lower limb paresis and no severe visual impairments. Over-ground visual cue training (O-VCT), Treadmill based visual cue training (T-VCT), and Usual care (UC) delivered by physiotherapists twice weekly for 8 weeks. Participants were randomised using computer generated random permutated balanced blocks of randomly varying size. Recruitment, retention, adherence, adverse events and mobility and balance were measured before randomisation, post-intervention and at four weeks follow-up. Fifty-six participants participated (18 T-VCT, 19 O-VCT, 19 UC). Thirty-four completed treatment and follow-up assessments. Of the participants that completed, adherence was good with 16 treatments provided over (median of) 8.4, 7.5 and 9 weeks for T-VCT, O-VCT and UC respectively. No adverse events were reported. Post-treatment improvements in walking speed, symmetry, balance and functional mobility were seen in all treatment arms. Outpatient based treadmill and over-ground walking adaptability practice using visual cues are feasible and may improve mobility and balance. Future studies should continue a carefully phased approach using identified methods to improve retention. Clinicaltrials.gov NCT01600391.

Dual-energy bone removal computed tomography (BRCT): preliminary report of efficacy of acute intracranial hemorrhage detection.

PubMed

Naruto, Norihito; Tannai, Hidenori; Nishikawa, Kazuma; Yamagishi, Kentaro; Hashimoto, Masahiko; Kawabe, Hideto; Kamisaki, Yuichi; Sumiya, Hisashi; Kuroda, Satoshi; Noguchi, Kyo

2018-02-01

One of the major applications of dual-energy computed tomography (DECT) is automated bone removal (BR). We hypothesized that the visualization of acute intracranial hemorrhage could be improved on BRCT by removing bone as it has the highest density tissue in the head. This preliminary study evaluated the efficacy of a DE BR algorithm for the head CT of trauma patients. Sixteen patients with acute intracranial hemorrhage within 1 day after head trauma were enrolled in this study. All CT examinations were performed on a dual-source dual-energy CT scanner. BRCT images were generated using the Bone Removal Application. Simulated standard CT and BRCT images were visually reviewed in terms of detectability (presence or absence) of acute hemorrhagic lesions. DECT depicted 28 epidural/subdural hemorrhages, 17 contusional hemorrhages, and 7 subarachnoid hemorrhages. In detecting epidural/subdural hemorrhage, BRCT [28/28 (100%)] was significantly superior to simulated standard CT [17/28 (61%)] (p = .001). In detecting contusional hemorrhage, BRCT [17/17 (100%)] was also significantly superior to simulated standard CT [11/17 (65%)] (p = .0092). BRCT was superior to simulated standard CT in detecting acute intracranial hemorrhage. BRCT could improve the detection of small intracranial hemorrhages, particularly those adjacent to bone, by removing bone that can interfere with the visualization of small acute hemorrhage. In an emergency such as head trauma, BRCT can be used as support imaging in combination with simulated standard CT and bone scale CT, although BRCT cannot replace a simulated standard CT.

Feasibility, Acceptability, and Preliminary Efficacy of a Smartphone Intervention for Schizophrenia

PubMed Central

Ben-Zeev, Dror; Brenner, Christopher J.; Begale, Mark; Duffecy, Jennifer; Mohr, David C.; Mueser, Kim T.

2014-01-01

The FOCUS smartphone intervention was developed to provide automated real-time/real-place illness management support to individuals with schizophrenia. The system was specifically designed to be usable by people with psychotic disorders who may have cognitive impairment, psychotic symptoms, negative symptoms, and/or low reading levels. FOCUS offers users both prescheduled and on-demand resources to facilitate symptom management, mood regulation, medication adherence, social functioning, and improved sleep. In this study, 33 individuals with schizophrenia or schizoaffective disorder used FOCUS over a 1-month period in their own environments. Participants were able to learn how to use the intervention independently, and all but one participant completed the trial successfully and returned the smartphones intact. Completers used the system on 86.5% of days they had the device, an average of 5.2 times a day. Approximately 62% of use of the FOCUS intervention was initiated by the participants, and 38% of use was in response to automated prompts. Baseline levels of cognitive functioning, negative symptoms, persecutory ideation, and reading level were not related to participants’ use of the intervention. Approximately 90% of participants rated the intervention as highly acceptable and usable. Paired samples t tests found significant reductions in psychotic symptoms, depression, and general psychopathology, after 1 month of FOCUS use. This study demonstrated the feasibility, acceptability, and preliminary efficacy of the FOCUS intervention for schizophrenia and introduces a new treatment model which has promise for extending the reach of evidence-based care beyond the confines of a physical clinic using widely available technologies. PMID:24609454

Clinical pharmacokinetics, safety, and preliminary efficacy evaluation of icotinib in patients with advanced non-small cell lung cancer.

PubMed

Liu, Dongyang; Zhang, Li; Wu, Yiwen; Jiang, Ji; Tan, Fenlai; Wang, Yingxiang; Liu, Yong; Hu, Pei

2015-09-01

To receive pharmacokinetics, safety, and anti-tumor activity of icotinib, a novel epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI), in patients with advanced non-small-cell lung cancer (NSCLC). Patients (n=40) with advanced NSCLC were enrolled to receive escalating doses of icotinib, which was administrated on Day 1 followed by 28-day continuous dosing starting from Day 4. Four dosing regimens, 100mg b.i.d., 150 mg b.i.d., 125 mg t.i.d., and 200mg b.i.d. were studied. Pharmacokinetics (PK), safety, and efficacy of icotinib were evaluated. Icotinib was well tolerated in Chinese patients with refractory NSCLC. No toxicity with >3 grades were reported in more than 2 patients under any dose levels. One complete response (3%) and 9 partial responses (23%) were received. Total disease control rate could reach at 73% and median progress-free survival (range) was 154 (17-462) days. PK exposure of icotinib increased with increase of dose in NSCLC patients. Food was suggested to increase PK exposure by ∼30%. Mean t1/2β was within 5.31-8.07 h. No major metabolite (>10% plasma exposure of icotinib) was found in NSCLC patients. Icotinib with up to 400 mg/day exhibited good tolerance and preliminary antitumor activity in Chinese NSCLC patients. Pharmacokinetics of icotinib and 5 major metabolites were fully investigated in NSCLC patients. Optimized biologic dose (OBD) was finally recommended to be 125 mg t.i.d. for the later clinical study. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Preliminary Validation of the Sex Trafficking Attitudes Scale.

PubMed

Houston-Kolnik, Jaclyn D; Todd, Nathan R; Wilson, Midge

2016-09-01

This study presents the Sex Trafficking Attitudes Scale (STAS), assessing cognitive, behavioral, and affective attitudes toward the sex trafficking of women and girls. Across two studies, exploratory and confirmatory factor analyses revealed and confirmed six subscales: (a) Knowledge About Sex Trafficking, (b) Awareness of Sex Trafficking, (c) Attitudes Toward Ability to Leave Sex Trafficking, (d) Attitudes Toward Helping Survivors, (e) Empathic Reactions Toward Sex Trafficking, and (f) Efficacy to Reduce Sex Trafficking. Results showed support for convergent validity as the subscales were associated with related measures. The STAS holds promise to expand research and inform efforts to support trafficking survivors. © The Author(s) 2016.

Speech and swallowing disorders in Parkinson disease.

PubMed

Sapir, Shimon; Ramig, Lorraine; Fox, Cynthia

2008-06-01

To review recent research and clinical studies pertaining to the nature, diagnosis, and treatment of speech and swallowing disorders in Parkinson disease. Although some studies indicate improvement in voice and speech with dopamine therapy and deep brain stimulation of the subthalamic nucleus, others show minimal or adverse effects. Repetitive transcranial magnetic stimulation of the mouth motor cortex and injection of collagen in the vocal folds have preliminary data supporting improvement in phonation in people with Parkinson disease. Treatments focusing on vocal loudness, specifically LSVT LOUD (Lee Silverman Voice Treatment), have been effective for the treatment of speech disorders in Parkinson disease. Changes in brain activity due to LSVT LOUD provide preliminary evidence for neural plasticity. Computer-based technology makes the Lee Silverman Voice Treatment available to a large number of users. A rat model for studying neuropharmacologic effects on vocalization in Parkinson disease has been developed. New diagnostic methods of speech and swallowing are also available as the result of recent studies. Speech rehabilitation with the LSVT LOUD is highly efficacious and scientifically tested. There is a need for more studies to improve understanding, diagnosis, prevention, and treatment of speech and swallowing disorders in Parkinson disease.

Relevance of Donepezil in Enhancing Learning and Memory in Special Populations: A Review of the Literature

ERIC Educational Resources Information Center

Yoo, J. Helen; Valdovinos, Maria G.; Williams, Dean C.

2007-01-01

This review discusses the laboratory and clinical research supporting the rationale for the efficacy of donepezil (Aricept[R] USA) in enhancing cognition in autism, Alzheimer disease, Down syndrome, traumatic brain injury, Attention Deficit Hyperactivity Disorder (ADHD), and schizophrenia. While preliminary animal models have shown effective,…

A Preliminary Efficacy and Feasibility of an Obstructive Sleep Apnea Educational Intervention in Oman

ERIC Educational Resources Information Center

Al Mezeini, Khamis Abdallah

2017-01-01

Background: Obstructive sleep apnea (OSA) is chronic disorder that contributes to multiple physiological and psychological conditions. Obstructive sleep apnea contributes to high rates of morbidity and mortality and has substantial impacts on both health care costs and the quality of life for affected individuals and their families. Healthcare…

The Use of Video Self-Modeling with English Language Learners: Implications for Success

ERIC Educational Resources Information Center

Ortiz, Jennifer; Burlingame, Cheryl; Onuegbulem, Cybeles; Yoshikawa, Koichi; Rojas, Eliana D.

2012-01-01

The efficacy of video self-modeling (VSM) to improve reading fluency for English language learners (ELLs) is explored. A review of the literature demonstrates the success of VSM in improving non-ELL students' fluency. Preliminary research with culturally and linguistically diverse students implies that the intervention can be equally effective…

Brief Report: Feasibility and Preliminary Efficacy of Individual Mindfulness Therapy for Adults with Autism Spectrum Disorder

ERIC Educational Resources Information Center

Conner, Caitlin M.; White, Susan W.

2018-01-01

Intervention research on adults with autism spectrum disorder (ASD) is sparse. Many adults with ASD experience impaired emotion regulation (ER), which is thought to contribute to higher rates of psychiatric comorbidities among adults with ASD and indirect effects upon adaptive functioning, interpersonal relationships, and vocational status. The…

Efficacy Trial of the Second Step Early Learning (SSEL) Curriculum: Preliminary Outcomes

ERIC Educational Resources Information Center

Upshur, Carole C.; Heyman, Miriam; Wenz-Gross, Melodie

2017-01-01

A classroom randomized trial (n = 31 classrooms) was conducted using the Second Step Early Learning (SSEL) curriculum compared to usual curricula. Head Start and community preschool classrooms enrolling low income children were randomly assigned to deliver SSEL (n = 16) or usual curricula (n = 15). Data are reported for four year olds…

Multisystemic Therapy for Child Non-Externalizing Psychological and Health Problems: A Preliminary Review

ERIC Educational Resources Information Center

Pane, Heather T.; White, Rachel S.; Nadorff, Michael R.; Grills-Taquechel, Amie; Stanley, Melinda A.

2013-01-01

Multisystemic therapy (MST) is effective for decreasing or preventing delinquency and other externalizing behaviors and increasing prosocial or adaptive behaviors. The purpose of this project was to review the literature examining the efficacy of MST for other child psychological and health problems reflecting non-externalizing behaviors,…

Preliminary Examination of Adolescent Spending in a Contingency Management-Based Smoking-Cessation Program

ERIC Educational Resources Information Center

Cavallo, Dana A.; Nich, Charla; Schepis, Ty S.; Smith, Anne E.; Liss, Thomas B.; McFetridge, Amanda K.; Krishnan-Sarin, Suchitra

2010-01-01

Contingency management (CM) utilizing monetary incentives is efficacious in enhancing abstinence in an adolescent smoking-cessation program, but how adolescents spend their money has not been examined. We assessed spending habits of 38 adolescent smokers in a CM-based smoking-cessation project prior to quitting and during treatment using a…

Various Assessments Utilized in California Preliminary Administrative Services Preparation Programs

ERIC Educational Resources Information Center

Erickson, Deborah E.

2016-01-01

Every two years, institutions sponsoring credentialing programs in California are required to submit a detailed biennial report, which includes data on at least four key assessments showing 1) candidate competence and/or 2) program efficacy. This article reports the types of assessments used from 25 institutions that completed biennial reports for…

Self-assessed efficacy of a clinical musculoskeletal anatomy workshop: A preliminary survey.

PubMed

Saavedra, Miguel Ángel; Navarro-Zarza, José E; Alvarez-Nemegyei, José; Canoso, Juan J; Kalish, Robert A; Villaseñor-Ovies, Pablo; Hernández-Díaz, Cristina

2015-01-01

To survey the efficacy of a practical workshop on clinical musculoskeletal anatomy held in five American countries. A self-assessment competence questionnaire sent to participants 1-3 months after the workshop. Results were compared to the results of a practical, instructor-assessed, pre-workshop test. The response rate of participants was 76.4%. The overall, self-assessed competence score for anatomical items that had been included in the pre-test was 76.9 (scale 0-100) as compared to an overall score of 48.1 in the practical, pre-workshop test (p<0.001). For items that were addressed in the workshop, but not included in the pre-test, self-assessed competence was rated at 62.9. Differences in anatomical knowledge between individuals from different countries and professional groups noted in the practical pre-test were no longer present in the post-test self-assessment. From this preliminary data and supporting evidence from the literature we believe that our anatomy workshop provides an effective didactic tool for increasing competence in musculoskeletal anatomy. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

A Powered Lower Limb Orthosis for Providing Legged Mobility in Paraplegic Individuals

PubMed Central

Quintero, Hugo A.; Farris, Ryan J.; Hartigan, Clare; Clesson, Ismari; Goldfarb, Michael

2012-01-01

This paper presents preliminary results on the development of a powered lower limb orthosis intended to provide legged mobility (with the use of a stability aid, such as forearm crutches) to paraplegic individuals. The orthosis contains electric motors at both hip and both knee joints, which in conjunction with ankle-foot orthoses, provides appropriate joint kinematics for legged locomotion. The paper describes the orthosis and the nature of the controller that enables the SCI patient to command the device, and presents data from preliminary trials that indicate the efficacy of the orthosis and controller in providing legged mobility. PMID:22707874

The relaxation response resiliency program (3RP) in patients with neurofibromatosis 1, neurofibromatosis 2, and schwannomatosis: results from a pilot study.

PubMed

Vranceanu, Ana-Maria; Merker, Vanessa L; Plotkin, Scott R; Park, Elyse R

2014-10-01

NF1, NF2, and Schwannomatosis are incurable tumor suppressor syndromes associated with poor quality of life. The aim of this study was to determine the feasibility, acceptability, and preliminary efficacy of an NF adapted, 8-week group mind body skills based intervention, the relaxation response resiliency program (3RP) aimed at improving resiliency and increasing satisfaction with life. Patients seen at MGH's Neurofibromatosis Clinic were offered participation if they described difficulties coping to a treating physician. Participants completed measures of life satisfaction, resiliency, stress, mood, lifestyle, pain, post-traumatic growth and mindfulness at baseline and after completing the 3RP program. The intervention had relative feasible enrollment rate (48% rate, 32 out of 67 of patients signing the informed consent form). However, out of the 32 patients who signed the informed consent, only 20 started the study (62.5%) and only 16 completed it (50%), suggesting problems with feasibility. The main reason cited for non-participation was burden of travel to the clinic. The intervention was highly acceptable, as evidenced by an 80% completion rate (16/20). Paired t tests showed significant improvement in resiliency, satisfaction with life, depression, stress, anxiety, mindfulness and post traumatic growth, with effect sizes ranging from 0.73-1.33. There was a trend for significance for improvement in somatization and sleepiness (p = 0.06), with effect sizes of 0.54-0.92 respectively. Statistically nonsignificant improvement was observed in all other measures, with effect sizes small to medium. In sum, the 3RP was found to be relatively feasible, highly acceptable and preliminary efficacious in decreasing symptom burden in this population, supporting the need of a randomized controlled trial.

Design and methods for "Commit to Get Fit" - a pilot study of a school-based mindfulness intervention to promote healthy diet and physical activity among adolescents.

PubMed

Salmoirago-Blotcher, Elena; Druker, Sue; Meyer, Florence; Bock, Beth; Crawford, Sybil; Pbert, Lori

2015-03-01

Cardiovascular prevention is more effective if started early in life, but available interventions to promote healthy lifestyle habits among youth have been ineffective. Impulsivity in particular has proven to be an important barrier to the adoption of healthy behaviors in youth. Observational evidence suggests that mindfulness interventions may reduce impulsivity and improve diet and physical activity. We hypothesize that mindfulness training in adjunct to traditional health education will improve dietary habits and physical activity among teenagers by reducing impulsive behavior and improving planning skills. The Commit to Get Fit study is a pilot cluster randomized controlled trial examining the feasibility, acceptability and preliminary efficacy of school-based mindfulness training in adjunct to traditional health education for promotion of a healthy diet and physical activity among adolescents. Two schools in central Massachusetts (30 students per school) will be randomized to receive mindfulness training plus standard health education (HE-M) or an attention-control intervention plus standard health education (HE-AC). Assessments will be conducted at baseline, intervention completion (2 months), and 8 months. Primary outcomes are feasibility and acceptability. Secondary outcomes include physical activity, diet, impulsivity, mood, body mass index, and quality of life. This study will provide important information about feasibility and preliminary estimates of efficacy of a school-delivered mindfulness and health education intervention to promote healthy dietary and physical activity behaviors among adolescents. Our findings will provide important insights about the possible mechanisms by which mindfulness training may contribute to behavioral change and inform future research in this important area. Copyright © 2015 Elsevier Inc. All rights reserved.

Design and methods for “Commit to Get Fit” – A pilot study of a school-based mindfulness intervention to promote healthy diet and physical activity among adolescents

PubMed Central

Salmoirago-Blotcher, Elena; Druker, Sue; Meyer, Florence; Bock, Beth; Crawford, Sybil; Pbert, Lori

2015-01-01

Introduction Cardiovascular prevention is more effective if started early in life, but available interventions to promote healthy lifestyle habits among youth have been ineffective. Impulsivity in particular has proven to be an important barrier to the adoption of healthy behaviors in youth. Observational evidence suggests that mindfulness interventions may reduce impulsivity and improve diet and physical activity. We hypothesize that mindfulness training in adjunct to traditional health education will improve dietary habits and physical activity among teenagers by reducing impulsive behavior and improving planning skills. Methods/Design The Commit to Get Fit study is a pilot cluster randomized controlled trial examining the feasibility, acceptability and preliminary efficacy of school-based mindfulness training in adjunct to traditional health education for promotion of a healthy diet and physical activity among adolescents. Two schools in central Massachusetts (30 students per school) will be randomized to receive mindfulness training plus standard health education (HE-M) or an attention-control intervention plus standard health education (HE-AC). Assessments will be conducted at baseline, intervention completion (2 months), and 8 months. Primary outcomes are feasibility and acceptability. Secondary outcomes include physical activity, diet, impulsivity, mood, body mass index, and quality of life. Conclusions This study will provide important information about feasibility and preliminary estimates of efficacy of a school-delivered mindfulness and health education intervention to promote healthy dietary and physical activity behaviors among adolescents. Our findings will provide important insights about the possible mechanisms by which mindfulness training may contribute to behavioral change and inform future research in this important area. PMID:25687667

The E Sibling Project – exploratory randomised controlled trial of an online multi-component psychoeducational intervention for siblings of individuals with first episode psychosis

PubMed Central

2013-01-01

Background Siblings of individuals with first episode psychosis are natural partners to promote service users’ recovery and are themselves vulnerable to mental ill health due to the negative impact of psychosis within the family. This study aims to develop and undertake a preliminary evaluation of the efficacy of an online multi-component psychoeducational intervention for siblings of individuals with first episode psychosis. The impetus for the intervention arose from siblings' expressed needs for peer support and information on psychosis, coping and management strategies for common symptoms and ways to promote recovery. Methods/Design The project design draws on the Medical Research Council framework for the design and evaluation of complex interventions. Mixed methods comprising collection of qualitative focus group data, systematic review and expert advisory group consultation are used to develop the theoretical basis for and design of the intervention. This protocol focuses on the modelling and piloting phase which uses a randomised controlled trial with factorial design to test the efficacy of the intervention. Outcome data on participants’ mental wellbeing, knowledge, perceived self-efficacy and experiences of caregiving will be assessed at baseline, at end of the intervention (10 weeks later) and at 10 week follow-up. In addition, a post-intervention semi-structured interview with 20% of the participants will explore their experiences and acceptability of the intervention. Discussion This multi-component online psychoeducational intervention aims to enhance siblings' knowledge about psychosis and their coping capacity, thus potentially improving their own mental wellbeing and promoting their contribution to service users’ recovery. The factorial design randomised controlled trial with a supplementary process evaluation using semi-structured interviews and usage-monitoring will collect preliminary evidence of efficacy, feasibility and acceptability, as well as feedback about the barriers and strategies to using such an innovative resource. The RCT will provide data for estimating the likely effect size of the intervention on outcomes for siblings and inform the development of a definitive future trial. Trial registration Trial registration: ISRCTN01416694 PMID:23622123

The E Sibling Project - exploratory randomised controlled trial of an online multi-component psychoeducational intervention for siblings of individuals with first episode psychosis.

PubMed

Sin, Jacqueline; Henderson, Claire; Pinfold, Vanessa; Norman, Ian

2013-04-26

Siblings of individuals with first episode psychosis are natural partners to promote service users' recovery and are themselves vulnerable to mental ill health due to the negative impact of psychosis within the family. This study aims to develop and undertake a preliminary evaluation of the efficacy of an online multi-component psychoeducational intervention for siblings of individuals with first episode psychosis. The impetus for the intervention arose from siblings' expressed needs for peer support and information on psychosis, coping and management strategies for common symptoms and ways to promote recovery. The project design draws on the Medical Research Council framework for the design and evaluation of complex interventions. Mixed methods comprising collection of qualitative focus group data, systematic review and expert advisory group consultation are used to develop the theoretical basis for and design of the intervention. This protocol focuses on the modelling and piloting phase which uses a randomised controlled trial with factorial design to test the efficacy of the intervention. Outcome data on participants' mental wellbeing, knowledge, perceived self-efficacy and experiences of caregiving will be assessed at baseline, at end of the intervention (10 weeks later) and at 10 week follow-up. In addition, a post-intervention semi-structured interview with 20% of the participants will explore their experiences and acceptability of the intervention. This multi-component online psychoeducational intervention aims to enhance siblings' knowledge about psychosis and their coping capacity, thus potentially improving their own mental wellbeing and promoting their contribution to service users' recovery. The factorial design randomised controlled trial with a supplementary process evaluation using semi-structured interviews and usage-monitoring will collect preliminary evidence of efficacy, feasibility and acceptability, as well as feedback about the barriers and strategies to using such an innovative resource. The RCT will provide data for estimating the likely effect size of the intervention on outcomes for siblings and inform the development of a definitive future trial. Trial registration: ISRCTN01416694.

Assessing self-efficacy and college readiness level among new undergraduate students in computer science using metacognitive awareness inventory (MAI)

NASA Astrophysics Data System (ADS)

Othman, Wan Nor Afiqah Wan; Abdullah, Aziman

2018-04-01

This preliminary study was conducted to address the issue of academic planning skills among new university student. Due to lack of proper measurement mechanism for awareness and readiness among students, this study proposes Metacognitive Awareness Inventory (MAI) to assess the connection between student self-efficacy and college readiness. Qualitative and quantitative approach were used by provide an online self-assessment for new student of Faculty of Computer Systems & Software Engineering (FSKKP) and analyse the data respectively. The possible relationships between MAI and College Readiness Item (CRI) in self-assessment has been evaluated. The sample size of 368 respondents from UMP are responding to the online self-assessment. The initial finding shows most student (71%) of the respondent lack of skills in planning. We manage to use Pearson Product-moment correlation coefficient to find the significant relationship between MAI and CRI. Thus, we found that College Readiness provide sufficient evidence that there is a significant correlation with most of MAI items. The findings also indicated not much difference was found between gender in terms of self-efficacy level. This paper suggests the MAI and CRI is a reliable and valid scale to respond the planning skills issues among new university students.

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

PubMed

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

2018-01-01

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

Optimal Health (Spirit, Mind, and Body): A Feasibility Study Promoting Well-Being for Health Behavior Change.

PubMed

Walker, Jenelle; Ainsworth, Barbara; Hooker, Steven; Keller, Colleen; Fleury, Julie; Chisum, Jack; Swan, Pamela

2015-10-01

Faith-based programs have shown beneficial effects for health and behaviors. Few have specifically intervened on the spiritual, mental (i.e., stress), and physical dimensions of well-being combined for health and healthy behaviors (i.e., exercise and diet). The purpose of this report is to describe the feasibility of executing a spirituality-based health behavior change, program founded upon the Spiritual Framework of Coping. This study was a quasi-experimental one group pretest-posttest design. Feasibility objectives were assessed, and limited efficacy of pretest and posttest measures was analyzed using paired t test (p < .05). Acceptance of the program was positive, and modest demand was shown with initial interest and an average attendance of 78.7%. The program was successfully implemented as shown by meeting session objectives and 88% homework completion. The program was practical for the intended participants and was successfully integrated within the existing environment. Limited efficacy measures showed no pre-post changes. This study provided preliminary support for the design and further testing of the theoretical components of the Spiritual Framework of Coping that informed the program.

Vehicle-Controlled, Phase 2 Clinical Trial of a Sustained-Release Dexamethasone Intracanalicular Insert in a Chronic Allergen Challenge Model.

PubMed

Torkildsen, Gail; Abelson, Mark B; Gomes, Paul J; McLaurin, Eugene; Potts, Susan L; Mah, Francis S

2017-03-01

To evaluate the efficacy and safety of a sustained-release dexamethasone intracanalicular insert (Dextenza™) in a model of allergic conjunctivitis. This was a randomized, double-masked, vehicle-controlled, Phase 2 study. Subjects had to have a positive conjunctival allergen challenge (CAC) reaction to allergen (bilateral +2 itching and redness on 5-point, 0-4 scales) at Visit 1, and for 2 of 3 time points on subsequent visits. Subjects who met entry criteria were randomized to receive Dextenza or PV (vehicle insert). Challenges occurred over 42 days, with efficacy assessed at 14 (primary endpoint visit), 28, and 40 days postinsertion. Outcome measures included the evaluation of ocular itching, redness, tearing, chemosis, eyelid swelling, rhinorrhea, and congestion. Twenty-eight subjects completed the study in the Dextenza group and 31 in the vehicle group. At 14 days postinsertion, Dextenza was statistically superior to PV, with least square mean differences for ocular itching of -0.76, -0.97, and -0.87 at 3, 5, and 7 min post-CAC, and for conjunctival redness of -0.46, -0.66, and -0.68 at 7, 15, and 20 min post-CAC. Clinical significance, defined as a 1-U decrease from PV, was not met for primary efficacy. Secondary endpoints, including number of subjects reporting itching and conjunctival redness, indicated superior performance of Dextenza compared with vehicle. Eleven Dextenza-treated (35.5%) and 10 vehicle-treated (30.3%) subjects each experienced a single adverse event. This Phase 2 study demonstrated preliminary efficacy and safety data of Dextenza for treatment of allergic conjunctivitis.

Prompt gamma-ray emission from biological tissues during proton irradiation: a preliminary study.

PubMed

Polf, J C; Peterson, S; Ciangaru, G; Gillin, M; Beddar, S

2009-02-07

In this paper, we present the results of a preliminary study of secondary 'prompt' gamma-ray emission produced by proton-nuclear interactions within tissue during proton radiotherapy. Monte Carlo simulations were performed for mono-energetic proton beams, ranging from 2.5 MeV to 250 MeV, irradiating elemental and tissue targets. Calculations of the emission spectra from different biological tissues and their elemental components were made. Also, prompt gamma rays emitted during delivery of a clinical proton spread-out Bragg peak (SOBP) in a homogeneous water phantom and a water phantom containing heterogeneous tissue inserts were calculated to study the correlation between prompt gamma-ray production and proton dose delivery. The results show that the prompt gamma-ray spectra differ significantly for each type of tissue studied. The relative intensity of the characteristic gamma rays emitted from a given tissue was shown to be proportional to the concentration of each element in that tissue. A strong correlation was found between the delivered SOBP dose distribution and the characteristic prompt gamma-ray production. Based on these results, we discuss the potential use of prompt gamma-ray emission as a method to verify the accuracy and efficacy of doses delivered with proton radiotherapy.

Assessment of Evidence Base from Medical Debriefs Data on Space Motion Sickness Incidence and Treatment

NASA Technical Reports Server (NTRS)

Younker, D.R.; Daniels, V.R.; Boyd, J.L.; Putcha, L.

2008-01-01

An objective of this data compilation and analysis project is to examine incidence and treatment efficacy of common patho-physiological disturbances during spaceflight. Analysis of medical debriefs data indicated that astronauts used medications to alleviate symptoms of four major ailments for which astronauts received treatment for sleep disturbances, space motion sickness (SMS), pain (headache, back pain) and sinus congestion. In the present data compilation and analysis project on SMS treatment during space missions, subject demographics (gender, age, first-time or repeat flyer), incidence and severity of SMS symptoms and subjective treatment efficacy from 317 crewmember debrief records were examined from STS-1 through STS-89. Preliminary analysis of data revealed that 50% of crew members reported SMS symptoms on at least one flight and 22% never experienced it. In addition, there were 387 medication dosing episodes reported, and promethazine was the most commonly used medication. Results of analysis of symptom check lists, medication use/efficacy and gender and flight record differences in incidence and treatment efficacy will be presented. Evidence gaps for treatment efficacy along with medication use trend analysis will be identified.

Effects of repetitive transcranial magnetic stimulation in performing eye-hand integration tasks: four preliminary studies with children showing low-functioning autism.

PubMed

Panerai, Simonetta; Tasca, Domenica; Lanuzza, Bartolo; Trubia, Grazia; Ferri, Raffaele; Musso, Sabrina; Alagona, Giovanna; Di Guardo, Giuseppe; Barone, Concetta; Gaglione, Maria P; Elia, Maurizio

2014-08-01

This report, based on four studies with children with low-functioning autism, aimed at evaluating the effects of repetitive transcranial magnetic stimulation delivered on the left and right premotor cortices on eye-hand integration tasks; defining the long-lasting effects of high-frequency repetitive transcranial magnetic stimulation; and investigating the real efficacy of high-frequency repetitive transcranial magnetic stimulation by comparing three kinds of treatments (high-frequency repetitive transcranial magnetic stimulation, a traditional eye-hand integration training, and both treatments combined). Results showed a significant increase in eye-hand performances only when high-frequency repetitive transcranial magnetic stimulation was delivered on the left premotor cortex; a persistent improvement up to 1 h after the end of the stimulation; better outcomes in the treatment combining high-frequency repetitive transcranial magnetic stimulation and eye-hand integration training. Based on these preliminary findings, further evaluations on the usefulness of high-frequency repetitive transcranial magnetic stimulation in rehabilitation of children with autism are strongly recommended. © The Author(s) 2013.

Genetic programming based models in plant tissue culture: An addendum to traditional statistical approach.

PubMed

Mridula, Meenu R; Nair, Ashalatha S; Kumar, K Satheesh

2018-02-01

In this paper, we compared the efficacy of observation based modeling approach using a genetic algorithm with the regular statistical analysis as an alternative methodology in plant research. Preliminary experimental data on in vitro rooting was taken for this study with an aim to understand the effect of charcoal and naphthalene acetic acid (NAA) on successful rooting and also to optimize the two variables for maximum result. Observation-based modelling, as well as traditional approach, could identify NAA as a critical factor in rooting of the plantlets under the experimental conditions employed. Symbolic regression analysis using the software deployed here optimised the treatments studied and was successful in identifying the complex non-linear interaction among the variables, with minimalistic preliminary data. The presence of charcoal in the culture medium has a significant impact on root generation by reducing basal callus mass formation. Such an approach is advantageous for establishing in vitro culture protocols as these models will have significant potential for saving time and expenditure in plant tissue culture laboratories, and it further reduces the need for specialised background.

Use of photo-Fenton's reaction by 400-nm LED light for endodontic disinfection: A preliminary in vitro study on Enterococcus faecalis.

PubMed

Lagori, Giuseppe; Fornaini, Carlo; Rocca, Jean-Paul; Merigo, Elisabetta

2017-06-01

One of the biggest challenges in endodontics is the complete disinfection of root canals. In addition to mechanical preparation, the technique traditionally also involves channel disinfection with other agents such as sodium hypochlorite, hydrogen peroxide, chlorhexidine, or a combination of these. Some bacterial species are particularly resistant to eradication. Using Enterococcus faecalis in this preliminary study, we tested the bactericidal effectiveness of the Fenton reaction and the photo-Fenton reaction using an LED light with a 400-nm wavelength. Discs of hydroxyapatite were incubated in brain-heart broth contaminated with Enterococcus faecalis. After 4days, they were decontaminated with different bactericidal agents, including some with proven and well-known efficacy (5% sodium hypochlorite and 3% hydrogen peroxide) and other treatments using solutions of 1.5% hydrogen peroxide and 0.15% iron gluconate (Fenton reaction) plus LED light at a Fluence of 4.0J/cm 2 (photo-Fenton reaction). The photo-Fenton reaction demonstrated comparable performance to that of sodium hypochlorite in eliminating Enterococcus faecalis. Copyright © 2017. Published by Elsevier B.V.

Modeling human-machine interactions for operations room layouts

NASA Astrophysics Data System (ADS)

Hendy, Keith C.; Edwards, Jack L.; Beevis, David

2000-11-01

The LOCATE layout analysis tool was used to analyze three preliminary configurations for the Integrated Command Environment (ICE) of a future USN platform. LOCATE develops a cost function reflecting the quality of all human-human and human-machine communications within a workspace. This proof- of-concept study showed little difference between the efficacy of the preliminary designs selected for comparison. This was thought to be due to the limitations of the study, which included the assumption of similar size for each layout and a lack of accurate measurement data for various objects in the designs, due largely to their notional nature. Based on these results, the USN offered an opportunity to conduct a LOCATE analysis using more appropriate assumptions. A standard crew was assumed, and subject matter experts agreed on the communications patterns for the analysis. Eight layouts were evaluated with the concepts of coordination and command factored into the analysis. Clear differences between the layouts emerged. The most promising design was refined further by the USN, and a working mock-up built for human-in-the-loop evaluation. LOCATE was applied to this configuration for comparison with the earlier analyses.

Family history of cancer as surrogate predictor for immunotherapy with anti-PD1/PD-L1 agents: preliminary report of the FAMI-L1 study.

PubMed

Cortellini, Alessio; Bersanelli, Melissa; Buti, Sebastiano; Gambale, Elisabetta; Atzori, Francesco; Zoratto, Federica; Parisi, Alessandro; Brocco, Davide; Pireddu, Annagrazia; Cannita, Katia; Iacono, Daniela; Migliorino, Maria R; Gamucci, Teresa; De Tursi, Michele; Sidoni, Tina; Tiseo, Marcello; Michiara, Maria; Papa, Anselmo; Angius, Gesuino; Tomao, Silverio; Fargnoli, Maria C; Natoli, Clara; Ficorella, Corrado

2018-06-01

Tumors related to hereditary susceptibility seem to have an immunosensitive phenotype. We conducted a multicenter retrospective study, to investigate if family history of cancer, multiple neoplasms and early onset of cancer could be related to clinical outcomes of anti-PD-1/PD-L1 therapy. Activity and efficacy data of 211 advanced cancer patients (kidney, non-small-cell lung cancer, melanoma, urothelium, colorectal and HeN), treated at seven Italian centers with anti-PD-1/PD-L1 agents, were analyzed. In this preliminary report at multivariate analyses, positive family history of cancer showed a statistically significant relationship with a better objective response rate (p = 0.0024), disease control rate (p = 0.0161), median time to treatment failure (p = 0.0203) and median overall survival (p = 0.0221). Diagnosis of multiple neoplasms significantly correlates only to a better disease control rate, while interestingly non-early onset of cancer and sex (in favor of female patients) showed significant correlation with a better median overall survival (p = 0.0268 and p = 0.0272, respectively).  This pilot study seems to individuate easily available patient's features as possible predictive surrogates of clinical benefit for anti-PD-1/PD-L1 treatments. These preliminary results need to be confirmed with a greater sample size, in prospective trials with immunotherapy.

Comparative evaluation of the antimicrobial efficacy of aloe vera tooth gel and two popular commercial toothpastes: an in vitro study.

PubMed

George, Dilip; Bhat, Sham S; Antony, Beena

2009-01-01

Aloe vera (Aloe barbadensis Miller) has been suggested for a wide variety of ailments but its use in dentistry is limited. This article reviews the uses of the plant and describes an in vitro investigation that compared the antimicrobial effectiveness of aloe vera tooth gel with two popular, commercially available dentifrices. The preliminary results showed that aloe vera tooth gel and the toothpastes were equally effective against Candida albicans, Streptococcus mutans, Lactobacillus acidophilus, Enterococcus faecalis, Prevotella intermedia, and Peptostreptococcus anaerobius. Aloe vera tooth gel demonstrated enhanced antibacterial effect against S. mitis.

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.

Wolbachia, doxycycline and macrocyclic lactones: New prospects in the treatment of canine heartworm disease.

PubMed

Kramer, L; Crosara, S; Gnudi, G; Genchi, M; Mangia, C; Viglietti, A; Quintavalla, C

2018-04-30

Melarsomine dihydrochloride (Immiticide®, Merial) is the only approved adulticidal drug for the treatment of canine heartworm disease (HWD). However, in cases where arsenical therapy is not possible or is contraindicated, a monthly heartworm preventive along with doxycycline for a 4-week period, which targets the bacterial endosymbiont Wolbachia, might be considered. There are published reports on the efficacy of ivermectin and doxycycline in both experimentally and naturally infected dogs, but no data on the use of other macrocyclic lactones (MLs) with a similar treatment regime. Preliminary results of studies in dogs show that a topical formulation of moxidectin, the only ML currently registered as a microfilaricide, is also adulticidal when combined with doxycycline. It is not yet known if the efficacy of these combination therapies is due to pharmacokinetic synergism. A recent study showed that serum levels of doxycycline in dogs treated with the combination protocol were not statistically different compared to dogs treated with doxycycline alone. However, lungs from dogs treated with the combination therapy showed a marked reduction in T regulatory cells, indicating that treatment efficacy may be due to a heightened immune response against the parasite. Further studies are necessary to evaluate the long-term clinical outcome of combination protocols and to establish the most efficient treatment for HWD in dogs. Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

Efficacy of the trial-based thought record, a new cognitive therapy strategy designed to change core beliefs, in social phobia.

PubMed

de Oliveira, I R; Powell, V B; Wenzel, A; Caldas, M; Seixas, C; Almeida, C; Bonfim, T; Grangeon, M C; Castro, M; Galvão, A; de Oliveira Moraes, R; Sudak, D

2012-06-01

Social anxiety disorder (SAD) often follows a chronic course and is associated with substantial impairment in functioning. Although results from clinical trials clearly establish evidence for efficacy of cognitive behavioural therapy in treating this disorder, up to 50% of patients with SAD show little or no improvement. Thus, new approaches that have promised in improving the efficacy of treatment for SAD are needed. One such approach is the trial-based thought record (TBTR), which targets the restructuring of patients' core beliefs. To determine whether patients receiving TBTR would report fewer symptoms of social anxiety and general psychiatric distress following treatment, relative to conventional cognitive therapy (CCT). A two-arm randomized trial comparing TBTR (n = 17) with a set of CCT techniques (n = 19), which included the standard seven-column dysfunctional thought record and the positive data log in SAD patients according to DSM-IV. Scores on many outcome measures decreased significantly across the course of treatment in both groups (P < 0·001), including the Liebowitz Social Anxiety Scale, Fear of Negative Evaluation Scale (FNE), Social Avoidance and Distress Scale (SADS), Beck Anxiety Inventory, and Clinical Global Impression - Improvement. In addition, a one-way ancova, taking baseline values as covariates, showed that TBTR was significantly more efficacious than CCT in reducing the scores of FNE (P = 0·01 at mid-treatment and P = 0·004 at post-treatment), and SADS (P = 0·03 at post-treatment). This study provides preliminary evidence that TBTR is at least as efficacious as CCT in reducing symptoms of SAD, pointing to the need for additional studies of TBTR in SAD and other psychiatric disorders. © 2011 Blackwell Publishing Ltd.

Feasibility, Acceptability, and Preliminary Efficacy of a Live-Chat Social Media Intervention to Reduce HIV Risk Among Young Men Who Have Sex With Men

PubMed Central

Pachankis, John E.; Gamarel, Kristi E.; Surace, Anthony; Golub, Sarit A.; Parsons, Jeffrey T.

2014-01-01

Given the popularity of social media among young men who have sex with men (YMSM), and in light of YMSM’s elevated and increasing HIV rates, we tested the feasibility, acceptability and preliminary efficacy of a live chat intervention delivered on Facebook in reducing condomless anal sex and substance use within a group of high risk YMSM in a pre-post design with no control group. Participants (N = 41; 18–29 years old) completed up to eight one-hour motivational interviewing and cognitive behavioral skills-based online live chat intervention sessions, and reported on demographic, psychosocial, and behavioral characteristics at baseline and immediately post-intervention. Analyses indicated that participation in the intervention (n = 31) was associated with reductions of days of drug and alcohol use in the past month and instances of anal sex without a condom (including under the influence of substances), as well as increases in knowledge of HIV-related risks at 3-month follow-up. This pilot study argues for the potential of this social media-delivered intervention to reduce HIV risk among a most vulnerable group in the United States, in a manner that was highly acceptable to receive and feasible to execute. A future randomized controlled trial could generate an intervention blueprint for providers to support YMSM’s wellbeing by reaching them regardless of their geographical location, at a low cost. PMID:25256808

Spatial Temporal Mathematics at Scale: An Innovative and Fully Developed Paradigm to Boost Math Achievement among All Learners

ERIC Educational Resources Information Center

Rutherford, Teomara; Kibrick, Melissa; Burchinal, Margaret; Richland, Lindsey; Conley, AnneMarie; Osborne, Keara; Schneider, Stephanie; Duran, Lauren; Coulson, Andrew; Antenore, Fran; Daniels, Abby; Martinez, Michael E.

2010-01-01

This paper describes the background, methodology, preliminary findings, and anticipated future directions of a large-scale multi-year randomized field experiment addressing the efficacy of ST Math [Spatial-Temporal Math], a fully-developed math curriculum that uses interactive animated software. ST Math's unique approach minimizes the use of…

Preliminary Evidence on the Effectiveness of Psychological Treatments Delivered at a University Counseling Center

ERIC Educational Resources Information Center

Minami, Takuya; Davies, D. Robert; Tierney, Sandra Callen; Bettmann, Joanna E.; McAward, Scott M.; Averill, Lynnette A.; Huebner, Lois A.; Weitzman, Lauren M.; Benbrook, Amy R.; Serlin, Ronald C.; Wampold, Bruce E.

2009-01-01

Treatment data from a university counseling center (UCC) that utilized the Outcome Questionnaire-45.2 (OQ-45; M. J. Lambert et al., 2004), a self-report general clinical symptom measure, was compared against treatment efficacy benchmarks from clinical trials of adult major depression that utilized similar measures. Statistical analyses suggested…

76 FR 65698 - Magnuson-Stevens Act Provisions; General Provisions for Domestic Fisheries; Application for...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-24

... Atlantic surfclam and ocean quahog Georges Bank Closure Area to continue testing the safety and efficacy of... research project that has been ongoing since 2006. NMS has made a preliminary determination that the...: http://www.nero.noaa.gov/sfd/clams . This project is a pilot program with the goal of determining if...

A preliminary RCT of CBT-AD for adherence and depression among HIV-positive Latinos on the U.S.-Mexico border: the Nuevo Día study.

PubMed

Simoni, Jane M; Wiebe, John S; Sauceda, John A; Huh, David; Sanchez, Giselle; Longoria, Virginia; Andres Bedoya, C; Safren, Steven A

2013-10-01

We conducted a preliminary RCT among 40 HIV-positive Latinos of Mexican descent on the U.S.-Mexico border who indicated imperfect adherence and depressive symptomatology. Participants were randomly assigned to culturally adapted cognitive-behavioral therapy for adherence and depression with an alarmed pillbox or usual care. Outcomes were depressive symptoms (self-report and blind clinician ratings), adherence (self-report and electronic pillbox), and biological markers. The intervention, delivered in English and Spanish, proved feasible and acceptable. Generalized estimating equations in intent-to-treat analyses showed some effects of "moderate" to "large" size, with maintenance over time. For example, intervention (vs. control) participants demonstrated at post-intervention a greater drop in BDI scores (OR = -3.64, p = 0.05) and greater adherence according to the electronic pillbox (OR = 3.78, p = 0.03). Biological markers indicated some relative improvement for CD4 count but not VL. The promising results suggest a larger trial to determine efficacy is warranted.

A randomized pilot trial of a videoconference couples communication intervention for advanced GI cancer.

PubMed

Porter, Laura S; Keefe, Francis J; Baucom, Donald H; Olsen, Maren; Zafar, S Yousuf; Uronis, Hope

2017-07-01

This study aims to test the feasibility and preliminary efficacy of a couple-based communication intervention for advanced GI cancer delivered via videoconference. Thirty-two couples were randomly assigned to either couples communication skills training (CCST) or an education comparison intervention, both delivered via videoconference. Participation was limited to couples who reported communication difficulties at screening. Patients and partners completed measures of relationship functioning and individual functioning at baseline and post-intervention. Eighty-eight percent of randomized dyads completed all six sessions and reported high levels of satisfaction with the intervention. Between-group effect sizes suggested that the CCST intervention led to improvements in relationship satisfaction for patients and partners and to improvements in intimacy and communication for patients. A couples-based communication intervention delivered via videoconference is feasible and acceptable in the context of advanced cancer. Preliminary findings suggest that the intervention shows promise in contributing to enhanced relationship functioning. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Association of plasma homovanillic acid with behavioral symptoms in patients diagnosed with dementia: a preliminary report.

PubMed

Sweet, R A; Pollock, B G; Mulsant, B H; Rosen, J; Lo, K H; Yao, J K; Henteleff, R A; Mazumdar, S

1997-12-01

Neuroleptic treatment of psychotic symptoms or agitated behavior in elderly patients diagnosed with dementia is associated with reduced efficacy and increased rates of neuroleptic-induced parkinsonism in comparison to younger patients with schizophrenia. We report the first study to examine the relationship between an in vivo measure of dopaminergic function, plasma homovanillic acid (pHVA), and ratings of psychosis, agitation, and parkinsonism before and after neuroleptic treatment in dementia patients. Pretreatment pHVA was significantly correlated with parkinsonian rigidity, with a trend observed with agitation and hostility. Though mean pHVA did not change during perphenazine treatment, intraindividual change in pHVA at day 15 was correlated with improvement in hostility, with a similar trend for improvement in agitation. These preliminary findings are consistent with reports associating dopaminergic function with agitated, but not psychotic, symptoms in patients diagnosed with dementia, and with a reduced responsivity of dopaminergic systems to neuroleptic treatment in these patients.

Control of oral human papillomavirus (HPV) by medicinal mushrooms, Trametes versicolor and Ganoderma lucidum: a preliminary clinical trial.

PubMed

Donatini, Bruno

2014-01-01

This preliminary randomized study investigated the efficacy of medicinal mushrooms, Trametes versicolor (TV), Ganoderma lucidum (GL), and Laetiporus sulphureus (LS), on the clearance of oral human papillomavirus (HPV, serotypes 16 and 18). Among 472 patients who underwent oral swabs for gingivitis, 61 patients were positive for HPV16 or HPV18. Twenty patients were included in group 1 (LS) and 41 patients were included in group 2 (TV+GL) for 2 months. Polymerase chain reaction (PCR) for HPV was performed at inclusion and after 2 months. In group 1, the clearance was equal to 5% after 2 months of treatment. In group 2, the clearance was equal to 88% (P<0.001). The detection of HPV16 or HPV18 could become relevant in routine since positivity is frequent and because a harmless and costless treatment may exist. The use of TV+GL for the clearance of oral HPV deserves further investigation.

A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial.

PubMed

Williams, Hants; Silva, Susan; Simmons, Leigh Ann; Tanabe, Paula

2017-05-15

One of the most difficult symptoms for persons with sickle cell disease (SCD) to manage is chronic pain. Chronic pain impacts approximately one-third of persons with SCD and is associated with increased pain intensity, pain behavior, and frequency and duration of hospital visits. A promising category of nonpharmacological interventions for managing both physical and affective components of pain are mindfulness-based interventions (MBIs). The primary aim of this study is to conduct a randomized controlled study to evaluate the acceptability and feasibility, as well as to determine the preliminary efficacy, of a telephonic MBI for adults with SCD who have chronic pain. We will enroll 60 adult patients with SCD and chronic pain at an outpatient comprehensive SCD center in the southeastern United States. Patients will be randomized to either an MBI or a wait-listed control group. The MBI group will complete a six-session (60 minutes), telephonically delivered, group-based MBI program. The feasibility, acceptability, and efficacy of the MBI regarding pain catastrophizing will be assessed by administering questionnaires at baseline and weeks 1, 3, and 6. In addition, ten randomly selected MBI participants will complete semistructured interviews to help determine intervention acceptability. In this study protocol, we report detailed methods of the randomized controlled trial. Findings of this study will be useful to determine the acceptability, feasibility, and efficacy of an MBI for persons with SCD and chronic pain. ClinicalTrials.gov identifier: NCT02394587 . Registered on 9 February 2015.

Shiatsu and Acupressure: Two Different and Distinct Techniques

PubMed Central

Cabo, Fernando; Baskwill, Amanda; Aguaristi, Isaac; Christophe-Tchakaloff, Slava; Guichard, Jean-Philippe

2018-01-01

Background Although shiatsu has been taught in specialized schools in Japan since 1940, there is a limited amount of research for its practice. As a result, authors substitute shiatsu with acupressure to use available research on acupressure. It is the position of the authors that, while the two share common aspects, they are substantively different. This project was undertaken to describe technical differences and advocate for a clear distinction, especially in research studies and academic discussions. Methods To understand whether it is appropriate to include acupressure studies in the evidence for shiatsu an analysis of the references included in a frequently cited systematic review was conducted to collect information about the protocols. In addition, a preliminary exploration of shiatsu practitioners’ perceptions about the differences between shiatsu and acupressure is described. This exploration used videos of shiatsu and acupressure techniques and asked practitioners to comment on their perception of similarity. Discussion The results identified several key technical differences between the two, including type of pressure applied, the positioning of the thumb, and the way in which body weight is used. Researchers should separate shiatsu and acupressure in their designs and purposively choose one or the other. To facilitate such clarification, we have proposed a definition for shiatsu that may facilitate the differentiation between these two techniques. Conclusion The authors hope to stimulate discussion about the differences between shiatsu and acupressure, and to question the appropriateness of using acupressure studies as evidence of the efficacy of shiatsu. A true understanding of the efficacy of shiatsu cannot be determined until studies use a common definition of shiatsu and discontinue substituting acupressure research for evidence of shiatsu efficacy. When this happens, it is proposed that a clearer picture of the safety, efficacy, and mechanism of action of both shiatsu and acupressure will emerge. PMID:29881477

Shiatsu and Acupressure: Two Different and Distinct Techniques.

PubMed

Cabo, Fernando; Baskwill, Amanda; Aguaristi, Isaac; Christophe-Tchakaloff, Slava; Guichard, Jean-Philippe

2018-06-01

Although shiatsu has been taught in specialized schools in Japan since 1940, there is a limited amount of research for its practice. As a result, authors substitute shiatsu with acupressure to use available research on acupressure. It is the position of the authors that, while the two share common aspects, they are substantively different. This project was undertaken to describe technical differences and advocate for a clear distinction, especially in research studies and academic discussions. To understand whether it is appropriate to include acupressure studies in the evidence for shiatsu an analysis of the references included in a frequently cited systematic review was conducted to collect information about the protocols. In addition, a preliminary exploration of shiatsu practitioners' perceptions about the differences between shiatsu and acupressure is described. This exploration used videos of shiatsu and acupressure techniques and asked practitioners to comment on their perception of similarity. The results identified several key technical differences between the two, including type of pressure applied, the positioning of the thumb, and the way in which body weight is used. Researchers should separate shiatsu and acupressure in their designs and purposively choose one or the other. To facilitate such clarification, we have proposed a definition for shiatsu that may facilitate the differentiation between these two techniques. The authors hope to stimulate discussion about the differences between shiatsu and acupressure, and to question the appropriateness of using acupressure studies as evidence of the efficacy of shiatsu. A true understanding of the efficacy of shiatsu cannot be determined until studies use a common definition of shiatsu and discontinue substituting acupressure research for evidence of shiatsu efficacy. When this happens, it is proposed that a clearer picture of the safety, efficacy, and mechanism of action of both shiatsu and acupressure will emerge.

Efficacy of Eye Movement Desensitization and Reprocessing in Children and Adolescent with Post-traumatic Stress Disorder: A Meta-Analysis of Randomized Controlled Trials.

PubMed

Moreno-Alcázar, Ana; Treen, Devi; Valiente-Gómez, Alicia; Sio-Eroles, Albert; Pérez, Víctor; Amann, Benedikt L; Radua, Joaquim

2017-01-01

Background: Post-traumatic stress disorder (PTSD) can occur in both adults and children/adolescents. Untreated PTSD can lead to negative long-term mental health conditions such as depression, anxiety, low self-concept, disruptive behaviors, and/or substance use disorders. To prevent these adverse effects, treatment of PTSD is essential, especially in young population due to their greater vulnerability. The principal aim of this meta-analysis was to examine the efficacy of eye movement desensitization and reprocessing (EMDR) therapy for PTSD symptoms in children and adolescents. Secondary objectives were to assess whether EMDR therapy was effective to improve depressive or anxious comorbid symptoms. Methods: We conducted a thorough systematic search of studies published until January 2017, using PubMed, Medline, Scopus, and ScienceDirect as databases. All randomized controlled trials with an EMDR group condition compared to a control group, such as treatment as usual or another psychological treatment, were included. Meta-analysis was conducted with MetaNSUE to avoid biases related to missing information. Results: Eight studies ( n = 295) met our inclusion criteria. EMDR therapy was superior to waitlist/placebo conditions and showed comparable efficacy to cognitive behavior therapy (CBT) in reducing post-traumatic and anxiety symptoms. A similar but non-statistically significant trend was observed for depressive symptoms. Exploratory subgroup analyses showed that effects might be smaller in studies that included more males and in more recent studies. Conclusion: Despite the small number of publications, the obtained results suggest that EMDR therapy could be a promising psychotherapeutic approach for the treatment of PTSD and comorbid symptoms in young individuals. However, further research with larger samples is needed to confirm these preliminary results as well as to analyze differences in the efficacy of EMDR therapy versus CBT.

Mesenchymal stromal cell-based therapy: Regulatory and translational aspects in gastroenterology.

PubMed

Dothel, Giovanni; Raschi, Emanuel; Rimondini, Roberto; De Ponti, Fabrizio

2016-11-07

The past decade has witnessed an outstanding scientific production focused towards the possible clinical applications of mesenchymal stromal cells (MSCs) in autoimmune and chronic inflammatory diseases. This raised the need of novel standards to adequately address quality, efficacy and safety issues of this advanced therapy. The development of a streamlined regulation is currently hampered by the complexity of analyzing dynamic biological entities rather than chemicals. Although numerous pieces of evidence show efficacy in reducing intestinal inflammation, some inconsistencies between the mechanisms of action of rodent vs human MSCs suggest caution before assigning translational value to preclinical studies. Preliminary evidence from clinical trials showed efficacy of MSCs in the treatment of fistulizing Crohn's disease (CD), and preparations of heterologous MSCs for CD treatment are currently tested in ongoing clinical trials. However, safety issues, especially in long-term treatment, still require solid clinical data. In this regard, standardized guidelines for appropriate dosing and methods of infusion could enhance the likelihood to predict more accurately the number of responders and the duration of remission periods. In addition, elucidating MSC mechanisms of action could lead to novel and more reliable formulations such as those derived from the MSCs themselves ( e.g ., supernatants).

Review: aromatase inhibitors for ovulation induction.

PubMed

Casper, Robert F; Mitwally, Mohamed F M

2006-03-01

For the last 40 yr, the first line of treatment for anovulation in infertile women has been clomiphene citrate (CC). CC is a safe, effective oral agent but is known to have relatively common antiestrogenic endometrial and cervical mucous side effects that could prevent pregnancy in the face of successful ovulation. In addition, there is a significant risk of multiple pregnancy with CC, compared with natural cycles. Because of these problems, we proposed the concept of aromatase inhibition as a new method of ovulation induction that could avoid many of the adverse effects of CC. The objective of this review was to describe the different physiological mechanisms of action for CC and aromatase inhibitors (AIs) and compare studies of efficacy for both agents for ovulation induction. We conducted a systematic review of all the published studies, both controlled and noncontrolled, comparing CC and AI treatment, either alone or in combination with gonadotropins, for ovulation induction or augmentation, identified through the Entrez-PubMed search engine. Because of the recent acceptance of the concept of using AIs for ovulation induction, few controlled studies were identified, and the rest of the studies were pilot or preliminary comparisons. Based on these studies, it appears that AIs are as effective as CC in inducing ovulation, are devoid of any antiestrogenic side effects, result in lower serum estrogen concentrations, and are associated with good pregnancy rates with a lower incidence of multiple pregnancy than CC. When combined with gonadotropins for assisted reproductive technologies, AIs reduce the dose of FSH required for optimal follicle recruitment and improve the response to FSH in poor responders. Preliminary evidence suggests that AIs may replace CC in the future because of similar efficacy with a reduced side effect profile. Although worldwide experience with AIs for ovulation induction is increasing, at present, definitive studies in the form of randomized controlled trials comparing CC with AIs are lacking.

Long-Term Chamomile Therapy of Generalized Anxiety Disorder: A Study Protocol for a Randomized, Double-Blind, Placebo- Controlled Trial

PubMed Central

Mao, Jun J; Li, Qing S.; Soeller, Irene; Rockwell, Kenneth; Xie, Sharon X; Amsterdam, Jay D.

2017-01-01

Background Anxiety symptoms are among the most common reasons for consumers to use Complementary and Alternative Medicine (CAM) therapy. Although many botanicals have been proposed as putative remedies for anxiety symptoms, there has been a paucity of controlled trials of these remedies. A preliminary study of the anxiolytic effect of Chamomile (Matricaria recutita) in humans suggests that chamomile may have anxiolytic and antidepressant activity. We now seek to conduct a 5-year randomized, double-blind, placebo-substitution study to examine the short and long-term safety and efficacy of chamomile extract in Generalized Anxiety Disorder (GAD). Methods/Design 180 subjects with moderate to severe GAD will receive initial open-label pharmaceutical-grade chamomile extract 500–1,500 mg daily for 8 weeks. Responders to treatment who remain well for an additional 4 weeks of consolidation therapy, will be randomized to double-blind continuation therapy with either chamomile extract 500–1,500 mg daily or placebo for an additional 26 weeks. The primary outcome will be the time to relapse during study continuation therapy in each treatment condition. Secondary outcomes will include the proportion of subjects in each treatment condition who relapse, as well as the proportion of subjects with treatment-emergent adverse events. Quality of life ratings will also be compared between treatment conditions during short and long-term therapy. Discussion Many individuals with mental disorders decline conventional therapy and seek CAM therapies for their symptoms. Thus, the identification of effective CAM therapy is of relevance to reducing the burden of mental illness. This study builds upon our prior findings of significant superiority of chamomile versus placebo in reducing GAD symptoms. We now extend these preliminary findings by conducting a randomized long-term safety and efficacy study of chamomile in GAD. PMID:29057164

Treatment-resistant panic disorder: a systematic review.

PubMed

Freire, Rafael C; Zugliani, Morena M; Garcia, Rafael F; Nardi, Antonio E

2016-01-01

The prevalence of panic disorder (PD) in the population is high and these patients have work impairment, high unemployment rates, seek medical treatment more frequently and have more hospitalizations than people without panic symptoms. Despite the availability of pharmacological, psychological and combined treatments, approximately one-third of all PD patients have persistent panic attacks and other PD symptoms after treatment. MEDLINE/Pubmed, CENTRAL, PsycINFO and Web of Science databases were searched for clinical trials in treatment-resistant PD. Only studies published between 1980 and 2015, in English, with human subjects, considered "journal articles" and clinical trial were included. We included trials recruiting only adult subjects with treatment-resistant PD, consistent with criteria from DSM-III to DSM5. We included all prospective experimental studies. Case, case series, retrospective studies or studies with <10 PD subjects were not included. Only 11 articles were included in this review. There were few quality studies, only two were randomized, controlled and double blind. Augmentation of the pharmacological treatment with cognitive-behavioral therapy demonstrated some short-term efficacy in treatment-resistant PD. There were also preliminary evidences of efficacy for monotherapy with reboxetine and olanzapine, and augmentation with pindolol, divalproex sodium, aripiprazole and olanzapine in short-term treatment.

Checkpoint inhibitors and radiation treatment in Hodgkin's lymphoma : New study concepts of the German Hodgkin Study Group.

PubMed

Baues, C; Semrau, R; Gaipl, U S; Bröckelmann, P J; Rosenbrock, J; Engert, A; Marnitz, S

2017-02-01

Patients with classical Hodgkin's lymphoma (cHL) have a good prognosis even in advanced stages. However, combined chemo- and radiotherapy, as the standard of care, is also associated with treatment-related toxicities such as organ damage, secondary neoplasias, infertility, or fatigue and long-term fatigue. Many patients suffer from this burden although their cHL was cured. Therefore, the efficacy of immune checkpoint inhibitors like anti-PD1/PD-L1 antibodies in the treatment of solid cancers and also in HL offers new options. A remarkable and durable response rate with a favorable toxicity profile was observed in heavily pretreated cHL patients. Planning to perform prospective randomized clinical trials in the content of radio-immune treatment in patients with Hodgkin's lymphoma (HL), we transferred the results of preliminary clinical studies and basic research in clinical relevant study concepts. Based on these promising early phase trial data, the German Hodgkin Study Group (GHSG) will investigate innovative treatment regimens in upcoming phase II trials. The therapeutic efficacy and potential synergies of anti-PD1 antibodies in combination with chemo- or radiotherapy will be investigated in various settings of HL.

Ibogaine: complex pharmacokinetics, concerns for safety, and preliminary efficacy measures.

PubMed

Mash, D C; Kovera, C A; Pablo, J; Tyndale, R F; Ervin, F D; Williams, I C; Singleton, E G; Mayor, M

2000-09-01

Ibogaine is an indole alkaloid found in the roots of Tabernanthe Iboga (Apocynaceae family), a rain forest shrub that is native to western Africa. Ibogaine is used by indigenous peoples in low doses to combat fatigue, hunger and thirst, and in higher doses as a sacrament in religious rituals. Members of American and European addict self-help groups have claimed that ibogaine promotes long-term drug abstinence from addictive substances, including psychostimulants and opiates. Anecdotal reports attest that a single dose of ibogaine eliminates opiate withdrawal symptoms and reduces drug craving for extended periods of time. The purported efficacy of ibogaine for the treatment of drug dependence may be due in part to an active metabolite. The majority of ibogaine biotransformation proceeds via CYP2D6, including the O-demethylation of ibogaine to 12-hydroxyibogamine (noribogaine). Blood concentration-time effect profiles of ibogaine and noribogaine obtained for individual subjects after single oral dose administrations demonstrate complex pharmacokinetic profiles. Ibogaine has shown preliminary efficacy for opiate detoxification and for short-term stabilization of drug-dependent persons as they prepare to enter substance abuse treatment. We report here that ibogaine significantly decreased craving for cocaine and heroin during inpatient detoxification. Self-reports of depressive symptoms were also significantly lower after ibogaine treatment and at 30 days after program discharge. Because ibogaine is cleared rapidly from the blood, the beneficial aftereffects of the drug on craving and depressed mood may be related to the effects of noribogaine on the central nervous system.

Fluorescein-guided surgery for grade IV gliomas with a dedicated filter on the surgical microscope: preliminary results in 12 cases.

PubMed

Acerbi, Francesco; Broggi, Morgan; Eoli, Marica; Anghileri, Elena; Cuppini, Lucia; Pollo, Bianca; Schiariti, Marco; Visintini, Sergio; Orsi, Chiara; Franzini, Angelo; Broggi, Giovanni; Ferroli, Paolo

2013-07-01

Fluorescein is widely used as a fluorescent tracer for many applications. Its capability to accumulate in cerebral areas with blood-brain barrier damage makes it an ideal dye for intraoperative visualization of malignant gliomas (MG). We report our preliminary experience in fluorescein-guided removal of grade IV gliomas using a dedicated filter on the surgical microscope. In September 2011 we started a prospective phase II trial (FLUOGLIO) to evaluate the safety and obtain initial indications about the efficacy of fluorescein-guided surgery for MG. Patients with suspected MG amenable to complete resection of contrast-enhancing areas were eligible to participate in this study. This report is based on a preliminary analysis of the results of 12 patients with grade IV gliomas out of 15 consecutive cases (age range 48-72 years) enrolled since September 2011. Fluorescein was injected intravenously (i.v.) after intubation (5-10 mg/kg). The tumor was removed using a microsurgical technique and fluorescence visualization by BLU 400 or YELLOW 560 filters on a Pentero microscope (Carl Zeiss, Germany). The study was approved by our ethics committee and registered on the European Regulatory Authorities website (EudraCT no. 2011-002527-18). Histological analysis confirmed grade IV gliomas in 12/15 cases. Median preoperative tumor volume was 33.15 cm(3) (9.6-87.8 cm(3)). No adverse reaction related to the administration of fluorescein was registered. Contrast-enhanced tumor was completely removed in 75 % of the patients. This preliminary analysis suggested that the use of intravenous fluorescein during surgery on grade IV gliomas is safe and allows a high rate of complete resection of contrast-enhanced tumor at the early postoperative MRI.

Family-based treatment for transition age youth: parental self-efficacy and caregiver accommodation.

PubMed

Dimitropoulos, Gina; Landers, Ashley L; Freeman, Victoria E; Novick, Jason; Cullen, Olivia; Engelberg, Marla; Steinegger, Cathleen; Le Grange, Daniel

2018-01-01

Family-Based Treatment (FBT) is the first line of care in paediatric treatment while adult programs focus on individualized models of care. Transition age youth (TAY) with Anorexia Nervosa (AN) are in a unique life stage and between systems of care. As such, they and their caregivers may benefit from specialized, developmentally tailored models of treatment. The primary purpose of this study was to assess if parental self-efficacy and caregiver accommodation changed in caregivers during the course of FBT-TAY for AN. The secondary aim was to determine if changes in parental self-efficacy and caregiver accommodation contributed to improvements in eating disorder behaviour and weight restoration in the transition age youth with AN. Twenty-six participants (ages 16-22) and 39 caregivers were recruited. Caregivers completed the Parents versus Anorexia Scale and Accommodation and Enabling Scale for Eating Disorders at baseline, end-of-treatment (EOT), and 3 months follow-up. Unbalanced repeated measures designs for parental self-efficacy and caregiver accommodation towards illness behaviours were conducted using generalized estimation equations. Parental self-efficacy increased from baseline to EOT, although not significantly ( p =  .398). Parental self-efficacy significantly increased from baseline to 3 months post-treatment ( p  = .002). Caregiver accommodation towards the illness significantly decreased from baseline to EOT ( p  = 0.0001), but not from baseline to 3 months post-treatment ( p  = 1.000). Stepwise ordinary least squares regression estimates of eating disorder behaviour and weight restoration did not show that changes in parental-self efficacy and caregiver accommodation predict eating disorder behaviour or weight restoration at EOT or 3 months post-treatment. Our findings demonstrate, albeit preliminary at this stage, that FBT-TAY promotes positive increases in parental self-efficacy and assists caregivers in decreasing their accommodation to illness behaviours for transition age youth with AN. However, changes in the parental factors did not influence changes in eating and weight in the transition age youth.

Preventing and Responding to Sexual Misconduct: Preliminary Efficacy of a Peer-Led Bystander Training Program for Preventing Sexual Misconduct and Reducing Heavy Drinking Among Collegiate Athletes.

PubMed

Morean, Meghan E; Darling, Nancy; Smit, Jessie; DeFeis, Jolie; Wergeles, Maya; Kurzer-Yashin, Dana; Custer, Kaitlyn

2018-06-01

Sexual misconduct occurs with disproportionate frequency on college campuses, and alcohol is involved in most sexual assaults. Importantly, collegiate athletes are at risk for both heavy drinking and sexual misconduct. Thus, the current study evaluated the efficacy of a novel, 2.5-hr, peer-facilitated, interactive, group-based bystander intervention program for student athletes that integrated information on sexual misconduct and risky drinking (Preventing and Responding to Sexual Misconduct [PRSM]). In all, 205 athletes completed 25-min surveys immediately before and after the training, and 76 (of 94 invited) completed a 3-month follow-up. Participating in the workshop was associated with significant increases in acknowledgment that sexual misconduct is a problem on campus, knowledge of where to get help if sexual misconduct occurs, knowledge about the college's procedures for addressing sexual misconduct, confidence that the college's procedures for addressing sexual misconduct are fair, bystander confidence, and engagement in a range of bystander activities. A significant decrease in rape myths also was observed. Participating in the workshop also produced changes in alcohol-related beliefs and behaviors. After participating in PRSM, athletes reported increased expectations that drinking alcohol can produce negative effects including aggression and acute intoxication. Participating in the workshop also was associated with significant reductions in drinking frequency, the total number of drinks consumed per month, the maximum drinks consumed in 24 hours, the frequency of binge-drinking episodes, and the experience of alcohol-related problems. In sum, the PRSM program evidenced preliminary efficacy as a program designed to increase prosocial bystander behavior and decrease high-risk drinking among collegiate athletes; changes in beliefs and behaviors consistent with reducing risk for sexual misconduct and problem drinking were observed after workshop participation. Future research should evaluate whether the PRSM program is effective for use with other high-risk populations like fraternity members or more diverse institutions of higher education including large universities.

A preliminary randomized controlled trial of a behavioral exercise intervention for smoking cessation.

PubMed

Abrantes, Ana M; Bloom, Erika Litvin; Strong, David R; Riebe, Deborah; Marcus, Bess H; Desaulniers, Julie; Fokas, Kathryn; Brown, Richard A

2014-08-01

Previous exercise intervention studies for smoking cessation have been challenged by a number of methodological limitations that confound the potential efficacy of aerobic exercise for smoking cessation. The preliminary efficacy of a behavioral exercise intervention that incorporated features designed to address prior limitations was tested in a randomized controlled trial (RCT). Sixty-one smokers (65.6% female, mean age = 47.3 years, smoked a mean of 19.7 cigarettes/day) were randomized to receive either a 12-week exercise intervention or a 12-week health education contact control. Participants in both conditions received an 8-week telephone-delivered, standard smoking cessation protocol (with the transdermal nicotine patch). Follow-ups were conducted at the end of treatment (EOT), 6- and 12-month timepoints. There were no differences between conditions with respect to the number of weekly exercise or health education sessions attended (9.3±2.8 vs. 9.3±3.0, respectively). While not statistically significant, participants in the exercise condition demonstrated higher verified abstinence rates (EOT: 40% vs. 22.6%, odds ratio [OR] = 2.28; 6- and 12-month follow-ups: 26.7% vs. 12.9%, OR = 2.46). Irrespective of treatment condition, higher levels of moderate-to-vigorous exercise were associated with lower levels of depressive symptoms during the intervention. The results of this small RCT point toward the benefit of a behavioral exercise intervention designed to address previous methodological limitations for smoking cessation. Given the potential public health impact of the demonstrated efficacy of exercise for smoking cessation, the continued development and optimization of exercise interventions for smokers through larger RCTs merits pursuit. © The Author 2014. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Feasibility Study of an Interactive Multimedia Electronic Problem Solving Treatment Program for Depression: A Preliminary Uncontrolled Trial

PubMed Central

Berman, Margit I.; Jr., Jay C. Buckey; Hull, Jay G.; Linardatos, Eftihia; Song, Sueyoung L.; McLellan, Robert K.; Hegel, Mark T.

2014-01-01

Computer-based depression interventions lacking live therapist support have difficulty engaging users. This study evaluated the usability, acceptability, credibility, therapeutic alliance and efficacy of a stand-alone multimedia, interactive, computer-based Problem Solving Treatment program (ePST™) for depression. The program simulated live treatment from an expert PST therapist, and delivered 6 ePST™ sessions over 9 weeks. Twenty-nine participants with moderate-severe symptoms received the intervention; 23 completed a mini mally adequate dose of ePST™ (at least 4 sessions). Program usability, acceptability, credibility, and therapeutic alliance were assessed at treatment midpoint and endpoint. Depressive symptoms and health-related functioning were assessed at baseline, treatment midpoint (4 weeks), and study endpoint (10 weeks). Depression outcomes and therapeutic alliance ratings were also compared to previously published research on live PST and computer-based depression therapy. Participants rated the program as highly usable, acceptable, and credible, and reported a therapeutic alliance with the program comparable to that observed in live therapy. Depressive symptoms improved significantly over time. These findings also provide preliminary evidence that ePST™ may be effective as a depression treatment. Larger clinical trials with diverse samples are indicated. PMID:24680231

Methacrylate micro/nano particles prepared by spray drying: a preliminary in vitro/in vivo study.

PubMed

Muñoz Ortega, Begoña; Sallam, Marwa Ahmed; Marín Boscá, M Teresa

2016-09-01

Delivery systems controlling drug release only in the colon holds great promises since they improve utilization of drug and decrease the dosing times comparison with conventional forms. The aim of the present study was to prepare polymeric microparticles on the basis of Ciprofloxacin via oral route for the treatment of inflammatory bowel disease. Ciprofloxacin was selected because of its extensive coverage for intestinal flora, relatively favorable side-effect profile and preliminary data suggesting its efficacy in the treatment of active Crohn's Disease. Microparticles were prepared using different acrylic compounds, namely Eudragit® RL (PO) and RS (PO) and a mixture of both. Spray-drying was used as a preparation method of Ciprofloxacin/Eudragit® microparticles using a Mini Spray Dryer B-290 (Büchi, Postfach, Switzerland). In vitro dissolution studies were performed to choose the best formulation and selected microparticles were characterized by size and morphology by environmental scanning electron microscopy. Yield and encapsulation efficiency were calculated and in vivo/ex vivo experiments were investigated both of which suggest that selected microparticles can be used for colon targeting of drugs increasing residence time of the drug in the affected area.

A Preliminary Efficacy and Feasibility of an Obstructive Sleep Apnea Educational Intervention in Oman

NASA Astrophysics Data System (ADS)

Al Mezeini, Khamis Abdallah

Background: Obstructive sleep apnea (OSA) is chronic disorder that contributes to multiple physiological and psychological conditions. Obstructive sleep apnea contributes to high rates of morbidity and mortality and has substantial impacts on both health care costs and the quality of life for affected individuals and their families. Healthcare providers - particularly primary health care nurses - are ideally situated to interrupt the cascading consequences of OSA if they are equipped with evidence-based knowledge about the disease process and appropriate methods for screening, education, and preventive interventions. Purpose: The purpose of the study was to test the preliminary efficacy and feasibility of an online health educational intervention on the knowledge and attitudes of OSA among primary health care nurses in Oman. Methods: This study was designed to assess the preliminary efficacy and feasibility of an online educational program on OSA by randomly assigning subjects to either a treatment (OSA content) or attention control (diabetes content) group. At baseline, the OSA knowledge and attitudes of both groups were assessed by the Obstructive Sleep Apnea Knowledge and Attitudes (OSAKA) questionnaire; both groups also completed the Diabetes Basic Knowledge Test (DBKT) to use for control comparisons. Following randomization, the intervention group viewed a 15-minute narrated video on "Brief Introduction to OSA for Omani Nurses" and the control group viewed a similarly formatted 15-minute narrated video on diabetes. The intent was for the subjects in both groups to complete a posttest that included both the OSAKA and DBKT instruments; however, due to a programming error, the software did not present the DBKT to the intervention subjects and did not present the OSAKA instrument to the control subjects as intended. Therefore, the results describe the findings from a one-group, pretest-posttest intervention study to assess the preliminary efficacy and feasibility of the educational intervention. Feasibility data were also collected with face-to face interviews with a convenience sample of nurse administrators who oversee primary health care nurses in health centers in the Al-Batinah governorate in Oman. Results: Overall, the baseline OSA knowledge scores for the entire sample (N=156) were very low (M=8.87, SD=2.91; median=9, range 0-15 out of possible 18 points). There were no significant relationships between OSA knowledge and any of the demographic variables. There was no significant difference in the mean OSA knowledge scores (p=0.80, t =0.26) between the intervention group (M=8.90, SD=2.68, n=73) and the control group (M=8.84, SD=3.12, n=83) at baseline. Primary health care nurses in the intervention group (n = 73) had a significant improvement in posttest knowledge scores on the OSAKA as compared to pretest scores ( p = .037, t= -2.1). After the online OSA educational intervention, 91.8% (n=67) of participants (n=73) indicated they were "likely" or "very likely" to recommend the online video to other health professionals. Although posttest attitudes were higher than baseline for the intervention group, the difference did not reach statistical significance. Implications for Practice: The low levels of OSA knowledge in this sample of primary health care nurses may indicate that their ability to identify patients at risk for OSA, assess at-risk patients appropriately, or refer as needed to physicians is limited. Nursing educators may consider integrating content about sleep disorders - and OSA - into the baccalaureate nursing curricula. Continuing education programs might offer focused programs on sleep disorders and OSA to raise awareness among practicing nurses. Conclusion: Primary health care nurses in Oman are expected to assess patients, identify health risks, and refer as necessary to physicians or other practitioners. In this sample of primary health care nurses, knowledge about OSA was limited; low knowledge of risk factors, symptoms, and treatment options may undermine the nurses' ability to assure that patients who may have OSA are referred appropriately. Implications for basic nursing curricula and continuing education are offered.

Evaluation of AQUI-S(TM) (efficacy and minimum toxic concentration) as a fish anaesthetic/sedative for public aquaculture in the United States

USGS Publications Warehouse

Stehly, G.R.; Gingerich, W.H.

1999-01-01

A preliminary evaluation of efficacy and minimum toxic concentration of AQUI-S(TM), a fish anaesthetic/sedative, was determined in two size classes of six species of fish important to US public aquaculture (bluegill, channel catfish, lake trout, rainbow trout, walleye and yellow perch). In addition, efficacy and minimum toxic concentration were determined in juvenile-young adult (fish aged 1 year or older) rainbow trout acclimated to water at 7 ??C, 12 ??C and 17 ??C. Testing concentrations were based on determinations made with range-finding studies for both efficacy and minimum toxic concentration. Most of the tested juvenile-young adult fish species were induced in 3 min or less at a nominal AQUI-S(TM) concentration of 20 mg L-1. In juvenile-young adult fish, the minimum toxic concentration was at least 2.5 times the selected efficacious concentration. Three out of five species of fry-fingerlings (1.25-12.5 cm in length and < 1 year old) were induced in ??? 4.1 min at a nominal concentration of 20 mg L-1 AQUI-S(TM), with the other two species requiring nominal concentrations of 25 and 35 mg L-1 for similar times of induction. Recovery times were ??? 7.3 rain for all species in the two size classes. In fry-fingerlings, the minimum toxic concentration was at least 1.4 times the selected efficacious concentration. There appeared to be little relationship between size of fish and concentrations or times to induction, recovery times and minimum toxic concentration. The times required for induction and for recovery were increased in rainbow trout as the acclimation temperature was reduced.

[Efficacy analysis and theoretical study on Chinese herbal properties of Açaí (Euterpe oleracea)].

PubMed

Zhang, Jian-jun; Chen, Shao-hong; Zhu, Ying-li; Wang, Chun; Wang, Jing-xia; Wang, Lin-yuan; Gao, Xue-min

2015-06-01

Açaí (Euterpe oleracea) emerged as a source of herb has a long history in South America, which was approved by the Ministry of Health used in China and it has been introduced planting in Guangdong and Taiwan. This article summarized applied history of Açaí and its present status in China. Did theoretical study on the Chinese herbal properties of Açaí based on the Chinese traditional philosophical culture to analysis the function and symptom preliminary, combining with used for medical recordation, chemical component, biological activity. It is aiming at establishing the theoretical foundation for the application under the guidance of TCM theory.

Proposal of a model for multidisciplinary treatment program of chronic migraine with medication overuse: preliminary study.

PubMed

Grazzi, L; Prunesti, A; Bussone, G

2015-05-01

The treatment of patients with chronic migraine associated with medication overuse is challenging in clinical practice; different strategies of treatment have been recently developed, multidisciplinary treatment approaches have been developed in academic headache centers. Education and support of patients are necessary to improve patients' adherence to pharmacological treatments as well as to non-pharmacological therapies. This study reports a clinical experience conducted at our Headache center with a group of female patients, suffering from chronic migraine complicated by medication overuse, treated by a multidisciplinary approach and followed for a period of 1 year after withdrawal. Results confirm the efficacy of a multifaceted treatment to manage this problematic category of patients.

Feasibility and Preliminary Outcomes From a Pilot Study of an Integrated Health-Mental Health Promotion Program in School Mental Health Services

PubMed Central

George, Melissa W.; Trumpeter, Nevelyn N.; Wilson, Dawn K.; McDaniel, Heather L.; Schiele, Bryn; Prinz, Ron; Weist, Mark D.

2014-01-01

The prevalence of unmet health and mental health needs among youth has spurred the growing consensus to develop strategies that integrate services to promote overall well-being. This pilot study reports on the feasibility and outcomes of a theory-driven, family-focused, integrated health-mental health promotion program for underserved adolescents receiving school mental health services. Parent and adolescent assessments conducted prior to and following the brief, 6-session promotion program showed significant improvements in family support, youth self-efficacy, health behaviors, and mental health outcomes. Clinician reports contributed to a characterization of the feasibility, acceptability, and future recommendations for the integrated program. PMID:24297005

Randomised controlled trial of school-based humanistic counselling for emotional distress in young people: Feasibility study and preliminary indications of efficacy

PubMed Central

2010-01-01

Aims The purpose of this study was to test the feasibility of a randomised controlled trial comparing six weeks of humanistic school-based counselling versus waiting list in the reduction of emotional distress in young people, and to obtain initial indications of efficacy. Methods Following a screening procedure, young people (13 - 15 years old) who experienced emotional distress were randomised to either humanistic counselling or waiting list in this multi-site study. Outcomes were assessed using a range of self-report mental health measures, with the emotional symptoms subscale of the Strengths and Difficulties Questionnaire (SDQ) acting as the primary outcome indicator. Results Recruitment procedures were successful, with 32 young people consenting to participate in the trial and 27 completing endpoint measures. Trial procedures were acceptable to all involved in the research. No significant differences were found between the counselling and waiting list groups in reductions in levels of emotional symptoms (Hedges' g = 0.03), but clients allocated to counselling showed significantly greater improvement in prosocial behaviour (g = 0.89) with an average effect size (g) across the nine outcome measures of 0.25. Participants with higher levels of depressive symptoms showed significantly greater change. Conclusion This study suggested that a randomised controlled trial of counselling in schools is acceptable and feasible, although initial indications of efficacy are mixed. Trial registration Current Controlled Trials ISRCTN68290510. PMID:20412578

The use of atypical antipsychotics beyond psychoses: efficacy of quetiapine in bipolar disorder.

PubMed

Mundo, Emanuela; Cattaneo, Elisabetta; Zanoni, Silvia; Altamura, A Carlo

2006-06-01

Atypical antpsychotics have been sucessfully used in the treatment of bipolar disorder (BD), either as adjunctive or as monotherapy. Quetiapine is an atypical antipsychotic extensively used in the treatment of psychotic disorders. It has serotonergic and dopaminergic activity and it appears to be selective for the mesolimbic and mesocortical dopamine system. The aim of this paper was to review the recent literature on the use of quetiapine in the treatment of BD. The literature databases currently available online were searched for papers on quetiapine and BD. Papers and reports published between January 1995 and June 2005 were selected and reviewed critically. Augmentative low dose quetiapine was found to be effective in BD partially responsive to conventional mood-stabilizers. Manic and mixed episodes have been the best studied, and quetiapine was found to be effective either as monotherapy or as adjunctive therapy in both randomized clinical trials and open-label studies. Data on the use of quetiapine in bipolar depression showed a significant efficacy and high remission rates. Maintenance data suggested a role of quetiapine as a good alternative to classical mood stabilizers in reducing recurrence rates of BD. A few studies on the efficacy in rapid cycling BD have also been published. Quetiapine is an effective agent for the short- and long-term treatment of BD. The mechanism of action of quetiapine as a mood stabilizer is still unknown. Some preliminary data suggest the involvement of glutamate pathways but further studies are needed to clarify this issue.

First series of total robotic hysterectomy (TRH) using new integrated table motion for the da Vinci Xi: feasibility, safety and efficacy.

PubMed

Giannini, Andrea; Russo, Eleonora; Mannella, Paolo; Palla, Giulia; Pisaneschi, Silvia; Cecchi, Elena; Maremmani, Michele; Morelli, Luca; Perutelli, Alessandra; Cela, Vito; Melfi, Franca; Simoncini, Tommaso

2017-08-01

To present the first case series of total robotic hysterectomy (TRH), using integrated table motion (ITM), which is a new feature comprising a unique operating table by Trumpf Medical that communicates wirelessly with the da Vinci Xi surgical system. ITM has been specifically developed to improve multiquadrant robotic surgery such as that conducted in colorectal surgery. Between May and October 2015, a prospective post-market study was conducted on ITM in the EU in 40 cases from different specialties. The gynecological study group comprised 12 patients. Primary endpoints were ITM feasibility, safety and efficacy. Ten patients underwent TRH. Mean number of ITM moves was three during TRH; there were 31 instances of table moves in the ten procedures. Twenty-eight of 31 ITM moves were made to gain internal exposure. The endoscope remained inserted during 29 of the 31 table movements (94%), while the instruments remained inserted during 27 of the 31 moves (87%). No external instrument collisions or other problems related to the operating table were noted. There were no ITM safety-related observations and no adverse events. This preliminary study demonstrated the feasibility, safety and efficacy of ITM for the da Vinci Xi surgical system in TRH. ITM was safe, with no adverse events related to its use. Further studies will be useful to define the real role and potential benefit of ITM in gynecological surgery.

Cognitive behavioral therapy for body image and self-care (CBT-BISC) in sexual minority men living with HIV: A randomized controlled trial.

PubMed

Blashill, Aaron J; Safren, Steven A; Wilhelm, Sabine; Jampel, Jonathan; Taylor, S Wade; O'Cleirigh, Conall; Mayer, Kenneth H

2017-10-01

Body image disturbance is a distressing and interfering problem among many sexual minority men living with HIV, and is associated with elevated depressive symptoms and poor HIV self-care (e.g., antiretroviral therapy [ART] nonadherence). The current study tested the preliminary efficacy of a newly created intervention: cognitive-behavioral therapy for body image and self-care (CBT-BISC) for this population. The current study entailed a 2-arm randomized controlled trial (N = 44) comparing CBT-BISC to an enhanced treatment as usual (ETAU) condition. Analyses were conducted at 3 and 6 months after baseline. The primary outcome was body image disturbance (BDD-YBOCS), and secondary outcomes were ART adherence (electronically monitored via Wisepill), depressive symptoms (MADRS), and global functioning (GAF). At 3 months, the CBT-BISC condition showed substantial improvement in BDD-YBOCS (b = -13.6, SE = 2.7, 95% CI [-19.0, -8.3], p < .001; dppc2 = 2.39); MADRS (b = -4.9, SE = 2.8, 95% CI [-10.6, .70], p = .086; dppc2 = .87); ART adherence (b = 8.8, SE = 3.3, 95% CI [2.0, 15.6], p = .01; dppc2 = .94); and GAF (b = 12.3, SE = 3.2, 95% CI [6.1, 18.6], p < .001; dppc2 = 2.91) compared with the ETAU condition. Results were generally maintained, or improved, at 6 months; although, adherence findings were mixed depending on the calculation method. CBT-BISC shows preliminary efficacy in the integrated treatment of body image disturbance and HIV self-care behaviors among sexual minority men living with HIV. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Randomized controlled trial of dexamphetamine maintenance for the treatment of methamphetamine dependence.

PubMed

Longo, Marie; Wickes, Wendy; Smout, Matthew; Harrison, Sonia; Cahill, Sharon; White, Jason M

2010-01-01

To investigate the safety and efficacy of once-daily supervised oral administration of sustained-release dexamphetamine in people dependent on methamphetamine. Randomized, double-blind, placebo-controlled trial. Forty-nine methamphetamine-dependent drug users from Drug and Alcohol Services South Australia (DASSA) clinics. Participants were assigned randomly to receive up to 110 mg/day sustained-release dexamphetamine (n = 23) or placebo (n = 26) for a maximum of 12 weeks, with gradual reduction of the study medication over an additional 4 weeks. Medication was taken daily under pharmacist supervision. Primary outcome measures included treatment retention, measures of methamphetamine consumption (self-report and hair analysis), degree of methamphetamine dependence and severity of methamphetamine withdrawal. Hair samples were analysed for methamphetamine using liquid chromatography-mass spectrometry. Treatment retention was significantly different between groups, with those who received dexamphetamine remaining in treatment for an average of 86.3 days compared with 48.6 days for those receiving placebo (P = 0.014). There were significant reductions in self-reported methamphetamine use between baseline and follow-up within each group (P < 0.0001), with a trend to a greater reduction among the dexamphetamine group (P = 0.086). Based on hair analysis, there was a significant decrease in methamphetamine concentration for both groups (P < 0.0001). At follow-up, degree of methamphetamine dependence was significantly lower in the dexamphetamine group (P = 0.042). Dexamphetamine maintenance was not associated with serious adverse events. The results of this preliminary study have demonstrated that a maintenance pharmacotherapy programme of daily sustained-release amphetamine dispensing under pharmacist supervision is both feasible and safe. The increased retention in the dexamphetamine group, together with the general decreases in methamphetamine use, degree of dependence and withdrawal symptom severity, provide preliminary evidence that this may be an efficacious treatment option for methamphetamine dependence.

Robotic radiosurgery vs. brachytherapy as a boost to intensity modulated radiotherapy for tonsillar fossa and soft palate tumors: the clinical and economic impact of an emerging technology.

PubMed

Nijdam, W; Levendag, P; Fuller, D; Schulz, R; Prevost, J-B; Noever, I; Uyl-de Groot, C

2007-12-01

As a basis for making decisions regarding optimal treatment for patients with tonsillar fossa and soft palate tumors, we conducted a preliminary investigation of costs and quality of life (QoL) for two modalities [brachytherapy (BT) and robotic radiosurgery] used to boost radiation to the primary tumors following external beam radiotherapy. BT was well established in our center; a boost by robotic radiosurgery was begun more recently in patients for whom BT was not technically feasible. Robotic radiosurgery boost treatment has the advantage of being non-invasive and is able to reach tumors in cases where there is deep parapharyngeal tumor extension. A neck dissection was performed for patients with nodal-positive disease. Quality of life (pain and difficulty swallowing) was established in long-term follow-up for patients undergoing BT and over a one-year follow-up in robotic radiosurgery patients. Total hospital costs for both groups were computed. Our results show that efficacy and quality of life at one year are comparable for BT and robotic radiosurgery. Total cost for robotic radiosurgery was found to be less than BT primarily due to the elimination of hospital admission and operating room expenses. Confirmation of robotic radiosurgery treatment efficacy and reduced morbidity in the long term requires further study. Quality of life and cost analyses are critical to Health Technology Assessments (HTA). The present study shows how a preliminary HTA of a new medical technology such as robotic radiosurgery with its typical hypofractionation characteristics might be based on short-term clinical outcomes and assumptions of equivalence.

Feasibility and Preliminary Efficacy of Visual Cue Training to Improve Adaptability of Walking after Stroke: Multi-Centre, Single-Blind Randomised Control Pilot Trial

PubMed Central

Hollands, Kristen L.; Pelton, Trudy A.; Wimperis, Andrew; Whitham, Diane; Tan, Wei; Jowett, Sue; Sackley, Catherine M.; Wing, Alan M.; Tyson, Sarah F.; Mathias, Jonathan; Hensman, Marianne; van Vliet, Paulette M.

2015-01-01

Objectives Given the importance of vision in the control of walking and evidence indicating varied practice of walking improves mobility outcomes, this study sought to examine the feasibility and preliminary efficacy of varied walking practice in response to visual cues, for the rehabilitation of walking following stroke. Design This 3 arm parallel, multi-centre, assessor blind, randomised control trial was conducted within outpatient neurorehabilitation services Participants Community dwelling stroke survivors with walking speed <0.8m/s, lower limb paresis and no severe visual impairments Intervention Over-ground visual cue training (O-VCT), Treadmill based visual cue training (T-VCT), and Usual care (UC) delivered by physiotherapists twice weekly for 8 weeks. Main outcome measures: Participants were randomised using computer generated random permutated balanced blocks of randomly varying size. Recruitment, retention, adherence, adverse events and mobility and balance were measured before randomisation, post-intervention and at four weeks follow-up. Results Fifty-six participants participated (18 T-VCT, 19 O-VCT, 19 UC). Thirty-four completed treatment and follow-up assessments. Of the participants that completed, adherence was good with 16 treatments provided over (median of) 8.4, 7.5 and 9 weeks for T-VCT, O-VCT and UC respectively. No adverse events were reported. Post-treatment improvements in walking speed, symmetry, balance and functional mobility were seen in all treatment arms. Conclusions Outpatient based treadmill and over-ground walking adaptability practice using visual cues are feasible and may improve mobility and balance. Future studies should continue a carefully phased approach using identified methods to improve retention. Trial Registration Clinicaltrials.gov NCT01600391 PMID:26445137

Beneficial effects of dexmedetomidine on early postoperative cognitive dysfunction in pediatric patients with tonsillectomy.

PubMed

Han, Chuanlai; Fu, Rong; Lei, Weifu

2018-07-01

According to clinical investigations, early postoperative cognitive dysfunction is the most common adverse event in pediatric patients after tonsillectomy. A previous study has indicated that dexmedetomidine (DEX) is an efficient drug for the treatment of postoperative cognitive dysfunction. However, the efficacy of DEX in alleviating early postoperative cognitive dysfunction in pediatric patients following tonsillectomy has remained elusive, which was therefore assessed in the present study. A total of 186 children presenting with cognitive dysfunction subsequent to tonsillectomy were recruited to analyze the efficacy of DEX. Patients were randomly divided into two groups and received intravenous treatment with DEX (n=112) or placebo (n=74). Duration of treatment, dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of DEX were evaluated in a preliminary experiment. The improvement of postoperative cognitive function in children with tonsillectomy was analyzed with a Mini-Mental State Examination (MMSE) following treatment with DEX. A 40-item quality of life (MONEX-40) questionnaire was used to assess the efficacy of DEX. The plasma levels of interleukin (IL)-6, IL-1, tumor necrosis factor (TNF)-α, superoxide dismutase (SOD), neuron-specific enolase (NSE), C-reactive protein (CRP), cortisol and melatonin were also analyzed. The preliminary experiment determined that the DLT was 10 mg/kg and the MTD was 15 mg/kg. In the major clinical trial, it was revealed that MMSE scores in the DEX treatment group were markedly improved, indicating that DEX had a beneficial effect in pediatric patients with early postoperative cognitive dysfunction after tonsillectomy. In addition, IL-1and TNF-α were downregulated, while IL-6 and SOD were upregulated in patients with cognitive dysfunction after treatment with DEX compared with those in the placebo group. Furthermore, DEX treatment markedly decreased the serum levels of CRP, NSE cortisol and melatonin, which are associated with the occurrence of postoperative cognitive dysfunction in pediatric patients following tonsillectomy. In conclusion, intravenous administration of DEX at a dose of 10 mg/kg improves postoperative cognitive function in pediatric patients with tonsillectomy by decreasing the serum levels of inflammatory factors and stress-associated signaling molecules. Trial registration no. QLSDHOS0200810102C (Qilu Hospital of Shandong University, Jinan, China).

Efficacy of the Hydroalcoholic Extract of Tribulus terrestris on the Serum Glucose and Lipid Profile of Women With Diabetes Mellitus: A Double-Blind Randomized Placebo-Controlled Clinical Trial.

PubMed

Samani, Nasrin Babadaei; Jokar, Azam; Soveid, Mahmood; Heydari, Mojtaba; Mosavat, Seyed Hamdollah

2016-10-01

Considering traditional use of Tribulus terrestris in diabetes and proven antihyperglycemic and antihyperlipidemic effects of T terrestris in animal studies, we aimed to evaluate the efficacy of the hydroalcoholic extract of T terrestris on the serum glucose and lipid profile of women with non-insulin-dependent diabetes mellitus. Ninety-eight women with diabetes mellitus type 2 were randomly allocated to receive the T terrestris (1000 mg/d) or placebo for 3 months. The patients were evaluated in terms of the fasting blood glucose, 2-hour postprandial glucose, glycosylated hemoglobin, and lipid profile. Tribulus terrestris showed a significant blood glucose-lowering effect in diabetic women compared to placebo (P < .05). Also, the total cholesterol and low-density lipoprotein of T terrestris group was significantly reduced compared with placebo, while no significant effect was observed in the triglyceride and high-density lipoprotein levels. The study showed preliminary promising hypoglycemic effect of T terrestris in women with diabetes mellitus type 2. © The Author(s) 2016.

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

PubMed

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

2017-08-01

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

The efficacy of an intraoral fluoride-releasing system in irradiated head and neck cancer patients: a preliminary study.

PubMed

Meyerowitz, C; Watson, G E

1998-09-01

This study compared the anticaries effectiveness of an intraoral fluoride-releasing system, or IFRS, with a standard regimen of daily application of a 1.1 percent neutral sodium fluoride gel in custom trays. Caries protection in subjects in the IFRS group was comparable to that in subjects in the 1.1 percent neutral sodium fluoride group. The subjects all had head or neck cancer and had received radiation therapy, but no more recently than three months before taking part in the study. Overall, IFRS devices were well-tolerated and patient satisfaction was high. The IFRS appears to offer several advantages over the daily application of fluoride gels in custom trays.

The relationship of field burn severity measures to satellite-derived Burned Area Reflectance Classification (BARC) maps

Treesearch

Andrew Hudak; Penelope Morgan; Carter Stone; Pete Robichaud; Terrie Jain; Jess Clark

2004-01-01

Preliminary results are presented from ongoing research on spatial variability of fire effects on soils and vegetation from the Black Mountain Two and Cooney Ridge wildfires, which burned in western Montana during the 2003 fire season. Extensive field fractional cover data were sampled to assess the efficacy of quantitative satellite image-derived indicators of burn...

The Supporting a Teen's Effective Entry to the Roadway (STEER) Program: Feasibility and Preliminary Support for a Psychosocial Intervention for Teenage Drivers with ADHD

ERIC Educational Resources Information Center

Fabiano, Gregory A.; Hulme, Kevin; Linke, Stuart; Nelson-Tuttle, Chris; Pariseau, Meaghan; Gangloff, Brian; Lewis, Kemper; Pelham, William E.; Waschbusch, Daniel A.; Waxmonsky, James G.; Gormley, Matthew; Gera, Shradha; Buck, Melina

2011-01-01

Teenage drivers with attention-deficit/hyperactivity disorder (ADHD) are at considerable risk for negative driving outcomes, including traffic citations, accidents, and injuries. Presently, no efficacious psychosocial interventions exist for teenage drivers with ADHD. The Supporting a Teen's Effective Entry to the Roadway (STEER) program is a…

Questioning the Role of Children's Indigenous Games of Africa on Development of Fundamental Movement Skills: A Preliminary Review

ERIC Educational Resources Information Center

Lyoka, Philemon A.

2007-01-01

This paper interrogates the role children's indigenous games of Africa can play in the development of fundamental movement skills relevant in modernized sports. On a daily basis, children in Africa play varieties of traditional games that vary between tribes, communities and distances. However, the efficacy of these games in the development of…

Implementation Integrity of Practice-Based Coaching: Preliminary Results from the BEST in CLASS Efficacy Trial

ERIC Educational Resources Information Center

Sutherland, Kevin S.; Conroy, Maureen A.; Vo, Abigail; Ladwig, Crystal

2015-01-01

The purpose of this article is to describe the practice-based coaching model used in BEST in CLASS, a Tier-2 classroom-based intervention comprised of evidence-based instructional practices designed to prevent and ameliorate the chronic problem behaviors of young children at risk for the development of emotional/behavioral disorders. Following a…

Building Young Engineers: TASEM for Third Graders in Woodcreek Magnet Elementary School

ERIC Educational Resources Information Center

Varney, M. W.; Janoudi, A.; Aslam, D. M.; Graham, D.

2012-01-01

Following the success of summer-camp-based programs, a new program has been developed for in-school sessions focused around LEGO robotics to foster interest in STEM topics at a young age. The program has been implemented in a very diverse school, and preliminary results on the efficacy of the program are presented. (Contains 1 table and 6 figures.)

Preliminary Analysis of a Randomized Trial of Computer Attention Training in Children with Attention-Deficit/Hyperactivity Disorder

ERIC Educational Resources Information Center

Steiner, N.; Sidhu, T. K.; Frenette, E. C.; Mitchell, K.; Perrin, E. C.

2011-01-01

Clinically significant attention problems among children present a significant obstacle to increasing student achievement. Computer-based attention training holds great promise as a way for schools to address this problem. The aim of this project is to evaluate the efficacy of two computer-based attention training systems in schools. One program…

Progressive Adaptive Physical Activity in Stroke Improves Balance, Gait, and Fitness: Preliminary Results

PubMed Central

Michael, Kathleen; Goldberg, Andrew P.; Treuth, Margarita S.; Beans, Jeffrey; Normandt, Peter; Macko, Richard F.

2010-01-01

Purpose We conducted a noncontrolled pilot intervention study in stroke survivors to examine the efficacy of low-intensity adaptive physical activity to increase balance, improve walking function, and increase cardiovascular fitness and to determine whether improvements were carried over into activity profiles in home and community. Method Adaptive physical activity sessions were conducted 3 times/week for 6 months. The main outcomes were Berg Balance Scale, Dynamic Gait Index, 6-Minute Walk Test, cardiovascular fitness (VO2 peak), Falls Efficacy Scale, and 5-day Step Activity Monitoring. Results Seven men and women with chronic ischemic stroke completed the 6-month intervention. The mean Berg Balance baseline score increased from 33.9 ± 8.5 to 46 ± 6.7 at 6 months (mean ± SD; p = .006). Dynamic Gait Index increased from 13.7 ± 3.0 to 19.0 ± 3.5 (p = .01). Six-minute walk distance increased from 840 ± 110 feet to 935 ± 101 feet (p = 0.02). VO2 peak increased from 15.3 ± 4.1 mL/kg/min to 17.5 ± 4.7 mL/kg/min (p = .03). There were no significant changes in falls efficacy or free-living ambulatory activity. Conclusion A structured adaptive physical activity produces improvements in balance, gait, fitness, and ambulatory performance but not in falls efficacy or free-living daily step activity. Randomized studies are needed to determine the cardiovascular health and functional benefits of structured group physical activity programs and to develop behavioral interventions that promote increased free-living physical activity patterns. PMID:19581199

Internet based HIV prevention research targeting rural MSM: feasibility, acceptability, and preliminary efficacy

PubMed Central

Williams, M. L.; Daniel, C. M.; Clayton, S.

2008-01-01

Internet delivered primary prevention interventions for HIV risk reduction present significant challenges. Changing lifestyle behaviors, such as beginning to use condoms, is difficult and men seeking dates on line may want to avoid thinking about HIV risk which may lead to low initiation and high dropout rates. Many Internet delivered HIV risk reduction programs have mimicked face-to-face outreach programs, failing to take advantage of the Internet’s capabilities or did not conduct evaluation. This study focuses on examining the feasibility, acceptability, and efficacy of an Internet delivered HIV risk reduction program for rural men who have sex with men (MSM). The program included online recruiting, three intervention modules, each with two sessions, online questionnaires. The intervention was developed based on iterative research and the Information-Motivation-Behavioral skills model. Participants (N = 475) were randomly assigned to one of six module orders and data were collected automatically at pre-test and after each module. Data supports the feasibility and acceptability of the program as demonstrated by good retention and rapid program completion. Knowledge, self-efficacy, outcome expectancies and motivation increase in a dose response fashion. Post-intervention behavior changes included reduced anal sex and significant increases in condom use. Limitations include a short follow-up period, a predominantly young white rural sample, and the lack of an attention control. Overall the results of the study provide support for the efficacy of Internet-based interventions to reduce risk of HIV infection. Results also support traditional research methods to evaluate HIV prevention programs delivered exclusively through the Internet. PMID:18770021

Monamine oxidase inhibitors: current and emerging agents for Parkinson disease.

PubMed

Fernandez, Hubert H; Chen, Jack J

2007-01-01

Monoamine oxidase type B (MAO-B) is the predominant isoform responsible for the metabolic breakdown of dopamine in the brain. Selective inhibition of brain MAO-B results in elevation of synaptosomal dopamine concentrations. Data have been reported regarding the selective MAO-B inhibitors, rasagiline and selegiline, for the symptomatic treatment of Parkinson disease (PD). Selegiline has demonstrated efficacy as monotherapy in patients with early PD (Deprenyl and Tocopherol Antioxidative Therapy of Parkinsonism study), but evidence of selegiline efficacy as adjunctive treatment in levodopa-treated PD patients with motor fluctuations is equivocal. A new formulation of selegiline (Zydis selegiline) has been evaluated in 2 small, placebo-controlled studies as adjunctive therapy to levodopa. The Zydis formulation allows pregastric absorption of selegiline, minimizing first-pass metabolism, and thereby increasing selegiline bioavailability and reducing the concentration of amphetamine metabolites. Rasagiline is a selective, second-generation, irreversible MAO-B inhibitor, with at least 5 times the potency of selegiline in vitro and in animal models. Rasagiline has demonstrated efficacy in 1 large, randomized, double-blind, placebo-controlled trial (TVP-1012 in Early Monotherapy for Parkinson's Disease Outpatients) as initial monotherapy in patients with early PD, and in 2 large, controlled trials (Parkinson's Rasagiline: Efficacy and Safety in the Treatment of "Off," Lasting Effect in Adjunct Therapy With Rasagiline Given Once Daily) as adjunctive treatment in levodopa-treated PD patients with motor fluctuations. Unlike selegiline, rasagiline is an aminoindan derivative with no amphetamine metabolites. A randomized clinical trial is underway to confirm preclinical and preliminary clinical data suggesting rasagiline has disease-modifying effects.

Some Non-FDA Approved Uses for Neuromodulation in Treating Autonomic Nervous System Disorders: A Discussion of the Preliminary Support.

PubMed

Lee, Samuel; Abd-Elsayed, Alaa

2016-12-01

Neuromodulation, including cavernous nerve stimulation, gastric electrical stimulation, deep brain stimulation, and vagus nerve stimulation, has been used with success in treating several functional disease conditions. The FDA has approved the use of neuromodulation for a few indications. We discuss in our review article the evidence of using neuromodulation for treating some important disorders involving the autonomic nervous system that are not currently FDA approved. This was a review article that included a systematic online web search for human clinical studies testing the efficacy of neuromodulation in treating erectile dysfunction, gastroparesis, gastroesophageal reflux disease, obesity, asthma, and heart failure. Our review includes all feasibility studies, nonrandomized clinical trials, and randomized controlled trials. Our systematic literature search found 3, 4, 5, 4, 1, and 4 clinical studies relating to erectile dysfunction, gastroparesis, gastroesophageal reflux disease, obesity, asthma, and heart failure, respectively. This review article shows preliminary support based on clinical studies that neuromodulation can be of benefit for patients with important autonomic nervous system disease conditions that are not currently approved by the FDA. All of these investigational uses are encouraging; further studies are necessary and warranted for all indications discussed in this review before achieving FDA approval. © 2016 International Neuromodulation Society.

Spermatogenetic inhibition in men taking a combination of oral medroxyprogesterone acetate and percutaneous testosterone as a male contraceptive method.

PubMed

Soufir, J-C; Meduri, G; Ziyyat, A

2011-07-01

We previously demonstrated in a small pilot study that oral medroxyprogesterone acetate and percutaneous testosterone (OMP/PT) induce reversible spermatogenesis suppression. The aims of this study were to determine the rate of spermatogenetic inhibition and recovery and to obtain preliminary data on efficacy for a larger population under OMP/PT. A total of 35 healthy men with normal spermiograms requesting male hormonal contraception were treated with OMP (20 mg/day) and PT (50-125 mg/day) for periods up to 18 months. Couples were included in a contraceptive efficacy phase after a value of ≤1 million/ml spermatozoa was reached between 1 and 3 months of treatment. Sperm counts decreased by 47% at 1 month, reaching 90% at 2 months and 98-100% between 4 and 8 months. At 3 months, 80% of men had ≤1 million/ml spermatozoa. Follicle-stimulating hormone and luteinizing hormone decreased to 35% of pretreatment levels after 1 month of treatment and to 75-80% at 2 and 6 months, respectively. Plasma testosterone and estradiol levels were in the eugonadal range at 3, 6, 9 and 12 months of treatment. Dihydrotestosterone concentrations were 2-4 times higher than pretreatment values. The rate of spermatogenetic recovery was rapid (73 ± 29.5 days). During the efficacy phase (211 months for 25 couples), one pregnancy attributable to poor compliance of the male partner was observed. OMP/PT efficiently inhibits spermatogenesis in 80% of men, maintains testosterone at physiological levels and avoids the need for parenteral administration, which is poorly accepted by French men. These results justify larger studies to define a more adequate dosage of OMP/PT and to confirm its efficacy and safety.

Engagement in the Overdose RIsk InfOrmatioN (ORION) e-Health Tool for Opioid Overdose Prevention and Self-Efficacy: A Preliminary Study.

PubMed

Carrà, Giuseppe; Crocamo, Cristina; Humphris, Gerald; Tabacchi, Tommaso; Bartoli, Francesco; Neufeind, Julia; Scherbaum, Norbert; Baldacchino, Alexander

2017-12-01

Increasing awareness of, and information about, overdose risk is an appropriate approach in risk reduction. e-Health technology in substance use disorders is an opportunity to support behavioral changes related to public health concerns. The present study aimed to evaluate the short-term impact of an innovative e-health psychoeducational software, the Overdose RIsk InfOrmatioN (ORION) tool. The ORION programme provided relevant information to opioid-dependent individuals about the risk of suffering a drug overdose as a result of high risky and dysfunctional behaviors. Seven aggregate risk factors were identified through a systematic review and their outputs included in a risk estimation model. We recruited 194 opioid-dependent treatment-seeking individuals from the United Kingdom, Germany, Italy, and Denmark. All participants were given at study entry, and after their use of the software, the General Self-Efficacy (GSE) Scale. We found comparable pre- and post-ORION administration mean GSE scores (SD), 28.49 (5.50) and 28.32 (5.90), respectively (p = 0.297). However, there was an inverse correlation between the number of risk factors and reported levels of self-efficacy (p < 0.001). ORION was able to identify individuals who are most in need of reducing their modifiable risk factors with appropriate interventions. However, a one-shot e-health tool cannot influence complex domains such as self-efficacy unless this is used with other effective interventions. Nonetheless, the ORION tool is unique in its style and content of delivery, that is translating risks combination into a clear estimation, and will need further development such as (a) integration in smartphone-based e-health apps and (b) testing in other high-risk populations.

Messages for men: the efficacy of EPPM-based messages targeting men's physical activity.

PubMed

Hatchell, Alexandra C; Bassett-Gunter, Rebecca L; Clarke, Marie; Kimura, Stacey; Latimer-Cheung, Amy E

2013-01-01

The majority of men are insufficiently active. Men's tendencies to participate in risky behaviors and their inactivity likely contribute to their increased risk of morbidity and mortality. Physical activity decreases the risk of developing many chronic diseases and may be an optimal behavior to target in men's health interventions. However, educational resources promoting physical activity for men are lacking. To address this gap, we tested the efficacy of messages based upon the Extended Parallel Process Model (EPPM; Witte, 1992) to increase men's physical activity intentions and behaviors. Men who were not meeting physical activity guidelines (n = 611) were randomly assigned to read high or low efficacy physical activity messages paired with high or no health risk information. Participants read four brief messages on four consecutive days. Intentions were assessed at baseline and the first follow-up (Day 5). Manipulation check measures were assessed at Day 5. Behavior was assessed at baseline and the second follow-up (Day 14). Overall, the messages had small sized effects. A completer analysis revealed that although men's intentions to be active increased over the course of the study regardless of the messages they received, only men who received risk information significantly increased their physical activity. Men who received low efficacy and risk information were less likely to meet the physical activity guidelines at Day 14 than men who only received low efficacy information. From these results, we suggest preliminary recommendations for the development of physical activity messages for men and areas for future EPPM-based research. PsycINFO Database Record (c) 2013 APA, all rights reserved.

Brief Report: Relationships Among Spousal Communication, Self-Efficacy, and Motivation Among Expectant Latino Fathers Who Smoke

PubMed Central

Khaddouma, Alexander; Gordon, Kristina Coop; Fish, Laura J.; Bilheimer, Alecia; Gonzalez, Alecia; Pollak, Kathryn I.

2015-01-01

Objective Cigarette smoking is a prevalent problem among Latinos, yet little is known about what factors motivate them to quit smoking or make them feel more confident that they can. Given cultural emphases on familial bonds among Latinos (e.g., familismo), it is possible that communication processes among Latino spouses play an important role. The present study tested a mechanistic model in which perceived spousal constructive communication patterns predicted changes in level of motivation for smoking cessation through changes in self-efficacy among Latino expectant fathers. Methods Latino males (n = 173) and their pregnant partners participated in a couple-based intervention targeting males’ smoking. Couples completed self-report measures of constructive communication, self-efficacy (male partners only), and motivation to quit (male partners only) at four time points throughout the intervention. Results Higher levels of perceived constructive communication among Latino male partners predicted subsequent increases in male’s partners’ self-efficacy and, to a lesser degree, motivation to quit smoking; however, self-efficacy did not mediate associations between constructive communication and motivation to quit smoking. Furthermore, positive relationships with communication were only significant at measurements taken after completion of the intervention. Female partners’ level of perceived constructive communication did not predict male partners’ outcomes. Conclusion These results provide preliminary evidence to support the utility of couple-based interventions for Latino men who smoke. Findings also suggest that perceptions of communication processes among Latino partners (particularly male partners) may be an important target for interventions aimed increasing desire and perceived ability to quit smoking among Latino men. PMID:25844907

A Preliminary Trial: Double-Blind Comparison of Nefazodone, Bupropion-SR and Placebo in the Treatment of Cannabis Dependence

PubMed Central

Carpenter, Kenneth M.; McDowell, David; Brooks, Daniel J.; Cheng, Wendy; Levin, Frances R.

2009-01-01

The present study investigated the efficacy of nefazodone and bupropion-sustained release for treating cannabis dependence. A double blind, placebo controlled, piggy back design was employed to assess if nefazodone and bupropion-sustained release increased the probability of abstinence from cannabis and reduced the severity of cannabis dependence and cannabis withdrawal symptoms during a 13-week outpatient treatment program. One-hundred and six participants (M=32 years; Females n=25) were randomized to one of three medication conditions (nefazodone, bupropion-sustained release, or placebo) and participated in a weekly individually based coping skills therapy program. Results indicated a an increased probability of achieving abstinence over the course of treatment and a decrease in the severity of cannabis dependence and the withdrawal symptom of irritability. There were no significant effects demonstrated for nefazodone and bupropion-sustained release on cannabis use or cannabis withdrawal symptoms. The results indicate nefazodone and bupropion-sustained release may have limited efficacy in treating cannabis dependence. PMID:19219666

Vaccination of small Asian mongoose (Herpestes javanicus) against rabies.

PubMed

Blanton, Jesse D; Meadows, Anastasia; Murphy, Staci M; Manangan, Jamie; Hanlon, Cathleen A; Faber, Marie-Luise; Dietzschold, Bernhard; Rupprecht, Charles E

2006-07-01

Oral vaccination of free-ranging wildlife is a promising technique in rabies control. The small Asian mongoose (Herpestes javanicus) is an important reservoir of rabies on several Caribbean islands, but no vaccines have been evaluated for this species. Captive mongooses were used to test the safety and efficacy of the commercially licensed vaccinia-rabies glycoprotein (V-RG) recombinant vaccine and a newly developed genetically engineered oral rabies virus vaccine (SPBNGA-S). In one study using V-RG, no vaccinated animals developed detectable rabies virus-neutralizing antibodies, and all but one died after experimental challenge with rabies virus. In contrast, all animals given SPBNGA-S demonstrated seroconversion within 7 to 14 days after vaccination and survived rabies virus challenge. On the basis of these preliminary results indicating the greater efficacy of SPBNGA-S vs. V-RG vaccine, additional investigations will be necessary to determine the optimal dose and duration of vaccination, as well as incorporation of the SPBNGA-S vaccine into edible bait.

Increasing the efficacy of antitumor glioma vaccines by photodynamic therapy and local injection of allogeneic glioma cells

NASA Astrophysics Data System (ADS)

Christie, Catherine E.; Peng, Qian; Madsen, Steen J.; Uzal, Francisco A.; Hirschberg, Henry

2016-03-01

Immunotherapy of brain tumors involves the stimulation of an antitumor immune response. This type of therapy can be targeted specifically to tumor cells thus sparing surrounding normal brain. Due to the presence of the blood-brain barrier, the brain is relatively isolated from the systemic circulation and, as such, the initiation of significant immune responses is more limited than other types of cancers. The purpose of this study was to show that the efficacy of tumor primed antigen presenting macrophage vaccines could be increased by: (1) PDT of the priming tumor cells, and (2) injection of allogeneic glioma cells directly into brain tumors. Experiments were conducted in an in vivo brain tumor model using Fisher rats and BT4C (allogeneic) and F98 (syngeneic) glioma cells. Preliminary results showed that vaccination alone had significantly less inhibitory effect on F98 tumor growth compared to the combination of vaccination and allogeneic cell (BT4C) injection.

Systematic cultural adaptation of cognitive-behavioral therapy to reduce alcohol use among HIV-infected outpatients in western Kenya.

PubMed

Papas, Rebecca K; Sidle, John E; Martino, Steve; Baliddawa, Joyce B; Songole, Rogers; Omolo, Otieno E; Gakinya, Benson N; Mwaniki, Michael M; Adina, Japheth O; Nafula, Tobista; Owino-Ong'or, Willis D; Bryant, Kendall J; Carroll, Kathleen M; Goulet, Joseph L; Justice, Amy C; Maisto, Stephen A

2010-06-01

Two-thirds of those with HIV worldwide live in sub-Saharan Africa. Alcohol use is associated with the HIV epidemic through risky sex and suboptimal ARV adherence. In western Kenya, hazardous drinking was reported by HIV (53%) and general medicine (68%) outpatients. Cognitive behavioral treatment (CBT) has demonstrated strong efficacy to reduce alcohol use. This article reports on a systematic cultural adaptation and pilot feasibility study of group paraprofessional-delivered CBT to reduce alcohol use among HIV-infected outpatients in Eldoret, Kenya. Following adaptation and counselor training, five pilot groups were run (n = 27). Overall attendance was 77%. Percent days abstinent from alcohol (PDA) before session 1 was 52-100% (women) and 21-36% (men), and by session 6 was 96-100% (women) and 89-100% (men). PDA effect sizes (Cohen's d) between first and last CBT session were 2.32 (women) and 2.64 (men). Participants reported treatment satisfaction. Results indicate feasibility, acceptability and preliminary efficacy for CBT in Kenya.

Teaching Health versus Treating Illness: The Efficacy of Three Principles Correctional Counseling with People in an English Prison.

PubMed

Kelley, Thomas M; Hollows, Jacqueline; Lambert, Eric G; Savard, Dennis M; Pransky, Jack

2018-07-01

Three principles correctional counseling (3PCC) posits that people in prison have inner mental health they have obscured to varying degrees with their own thinking. 3PCC further posits that people in prison can rekindle and sustain this inner health via understanding how three psychospiritual principles-Universal Mind, consciousness, and thought-coalesce to form people's psychological experience. We review the three principles and explain how exposure to these principles can lead to improved mental health and improved behavior. Then, we describe 3PCC and distinguish it from prevailing correctional counseling methods. Finally, we present a preliminary study that examines the efficacy of 3PCC for improving the mental health and behavior of people in an English prison. Our findings show that participants exposed to 3PCC showed a significant improvement in mental well-being and purpose in life, significant reductions in anxiety and anger, and improved behavior in the prison community.

Applying the theory of planned behavior to promotion of whole-grain foods by dietitians.

PubMed

Chase, Kellie; Reicks, Marla; Jones, Julie Miller

2003-12-01

The objective of this preliminary study was to apply the theory of planned behavior to explain dietitians' intentions to promote whole-grain foods. Surveys were mailed to a random national sample of registered dietitians to assess knowledge and attitudinal, normative, and control beliefs regarding intention to promote whole-grain foods, with a 39% return rate (n=776, with 628 usable surveys from those working in direct patient care). About half of the respondents had a master's degree, and 58% had substantial experience in the dietetics field. The theory of planned behavior explained intention to promote whole grains to a moderate extent (df=3, F=74.5, R(2)=0.278, P<.001). Most were positive about the health benefits, and few perceived barriers to promotion. However, many had low levels of knowledge and self-efficacy regarding ability to help clients consume more whole-grain foods. Continuing education for dietitians should use strategies that enhance self-efficacy regarding ability to promote whole-grain foods.

Utilizing placebo mechanisms for dose reduction in pharmacotherapy.

PubMed

Doering, Bettina K; Rief, Winfried

2012-03-01

The knowledge and systematic application of the placebo effect remains limited, although its importance to the treatment of various medical conditions has increasingly been recognized. A possible application of the placebo effect to pharmacotherapy is seen in conditioning processes that aim at a placebo-controlled dose reduction of drugs while maintaining the efficacy of the medical treatment. The pairing of a placebo and a pharmacological agent may achieve satisfactory treatment outcomes in combination with a lower dose of medication. This procedure includes classic and instrumental conditioning processes that involve both conscious and non-conscious information processing. Although recent studies have gathered preliminary evidence for the efficacy of placebo-controlled dose reduction (e.g. in psoriasis and attention deficit hyperactivity disorder [ADHD]), they have also illustrated the difficulties that are inherent to this approach. We critically review previous approaches and discuss designs for clinical trials that seem appropriate to the investigation of conditioned placebo effects in pharmacotherapy. Copyright © 2011 Elsevier Ltd. All rights reserved.

Effect of commercial hauling practices and tanker cleaning treatments on raw milk microbiological quality.

PubMed

Darchuk, Emily M; Waite-Cusic, Joy; Meunier-Goddik, Lisbeth

2015-10-01

Consolidation of the US milk industry has led to use of tankers for up to 24 h in between thorough cleanings. As the heavy use of tankers has not been previously studied, the effect of this form of hauling on raw milk quality is unknown. This study focused on the effect of frequent tanker use during hauling on raw milk quality at a commercial facility. Standard tanker use (cleaned-in-place once per 24 h) served as our control and incremental cleaning treatments (water rinse after each load, water rinse after each load with a sanitizer treatment after 12 h, and 12 h of sanitizer treatment) were added to the study to understand if any effect could be mitigated by more frequent cleaning. Producer samples were collected from the farm before loading milk into the tanker as well as sampling the same milk directly out of the tanker truck before unloading at the manufacturer. The study was repeated at 2 different dairy manufacturing facilities, once during the summer and once during the winter. Milk quality was quantified through industry-relevant microbiological tests: individual bacteria count, thermophilic spore count, and preliminary incubation count. Within the study we defined a negative effect on milk quality as a statistically significant difference between the tanker and producer samples in any of the 3 microbial tests conducted between treatments. Results from the study showed no clear effect due to hauling in individual bacteria count, thermophilic spore count, or preliminary incubation counts. There was also no difference in milk quality between the 2 plants, suggesting that neither season nor location affected our results in the standard use variable. As we did not see a negative effect on milk quality in the standard use variable, the addition of cleaning treatments did not appear to provide any clear benefit. Tanker surface swabs and ATP swabs were also used to monitor tanker sanitation and the efficacy of cleaning treatments. Both surface and ATP swabs revealed differences between cleaning efficacy at the 2 facilities. Although the differences in efficacy did not influence tanker milk quality within our study, variability in sanitation may provide a source of contamination that could negatively affect raw milk quality in other areas. Based on this study, current hauling practices appear to be effective in mitigating any measurable effect on raw milk quality; however, further investigation is needed before making industry-wide recommendations. Copyright © 2015 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Full central neurokinin-1 receptor blockade is required for efficacy in depression: evidence from orvepitant clinical studies.

PubMed

Ratti, Emiliangelo; Bettica, Paolo; Alexander, Robert; Archer, Graeme; Carpenter, David; Evoniuk, Gary; Gomeni, Roberto; Lawson, Erica; Lopez, Monica; Millns, Helen; Rabiner, Eugenii A; Trist, David; Trower, Michael; Zamuner, Stefano; Krishnan, Ranga; Fava, Maurizio

2013-05-01

Full, persistent blockade of central neurokinin-1 (NK1) receptors may be a potential antidepressant mechanism. The selective NK1 antagonist orvepitant (GW823296) was used to test this hypothesis. A preliminary positron emission tomography study in eight male volunteers drove dose selection for two randomized six week studies in patients with major depressive disorder (MDD). Displacement of central [(11)C]GR205171 binding indicated that oral orvepitant doses of 30-60 mg/day provided >99% receptor occupancy for ≥24 h. Studies 733 and 833 randomized patients with MDD and 17-item Hamilton Depression Rating Scale (HAM-D)≥22 to double-blind treatment with orvepitant 30 mg/day, orvepitant 60 mg/day or placebo (1:1:1). Primary outcome measure was change from baseline in 17-item HAM-D total score at Week 6 analyzed using mixed models repeated measures. Study 733 (n=328) demonstrated efficacy on the primary endpoint (estimated drug-placebo differences of 30 mg: -2.41, 95% confidence interval (CI) (-4.50 to -0.31) p=0.0245; 60 mg: -2.86, 95% CI (-4.97 to -0.75) p=0.0082). Study 833 (n=345) did not show significance (estimated drug-placebo differences of 30 mg: -1.67, 95% CI (-3.73 to 0.39) p=0.1122; 60 mg: -0.76, 95% CI (-2.85 to 1.32) p=0.4713). The results support the hypothesis that full, long lasting blockade of central NK1 receptors may be an efficacious mechanism for the treatment of MDD.

Reliability and validity of the Chinese versions of self-efficacy and outcome expectations for osteoporosis medication adherence scales in Chinese immigrants.

PubMed

Qi, Bing-Bing; Resnick, Barbara

2014-01-01

To assess the psychometric properties of Chinese versions self-efficacy and outcome expectations on osteoporosis medication adherence (SEOMA-C and OEOMA-C) scales. Back-translated tools were assessed by internal consistency and R2 by structured equation modeling, confirmatory factor analyses, hypothesis testing, and criterion-related validity among 110 (81 females, 29 males) Mandarin-speaking immigrants (mean age = 63.44, SD = 9.63). The Cronbach's alpha for SEOMA-C and OEOMA-C is .904 and .937, respectively. There was fair and good fit of the measurement model to the data. Previous bone mineral density (BMD) testing, calcaneus BMD, self-efficacy for exercise, and osteoporosis medication adherence were positively related to SEOMA-C scores. These scales constitute some preliminary validity and reliability. Further refined and cultural sensitive items could be explored and added.

Development and Evaluation of a Multimedia CD-ROM for Exercise During Pregnancy and Postpartum

PubMed Central

Hausenblas, Heather A.; Brewer, Britton W.; Van Raalte, Judy L.; Cook, Brian; Downs, Danielle Symons; Weis, Carol Ann; Nigg, Claudio; Cruz, Amelia

2008-01-01

Objective To meet the need for an interactive product on exercise during pregnancy and postpartum, we developed and evaluated a personally-tailored multimedia CD-ROM. Methods Pregnant and postpartum women, who were randomly assigned to either the experimental group (PregXercise™ CD-ROM) or the control group (CD-ROM with neutral content), navigated through the CD-ROM for 1 hour. Main outcomes were exercise self-efficacy and knowledge. Results In analyses of covariance, compared with the control group, the experimental group had significant increases in self-efficacy and knowledge. Conclusion The multimedia CD-ROM delivering information about exercise motivation, guidelines, and prescription was effective in improving exercise self-efficacy and knowledge. Practice Implications Our preliminary results illustrate that healthcare professionals and researchers may use interactive multimedia for improving exercise behavior and related outcomes with pregnant and postpartum women. PMID:18068940

Rasagiline in the pharmacotherapy of Parkinson's disease--a review.

PubMed

Rascol, Olivier

2005-10-01

Despite the current efficacious symptomatic approaches, the search is on for new therapies for Parkinson's disease that can control the cardinal symptoms of the disease (tremor, rigidity and bradykinesia), control/prevent motor complications induced by long-term levodopa, act on non-motor disease symptoms (dementia, dysautonomia, pain, insomnia, falls) and halt disease progression. Rasagiline is a monoamine oxidase-B inhibitor that has demonstrated efficacy against the cardinal symptoms of Parkinson's disease when used as monotherapy in early Parkinson's disease, and as an adjunct to levodopa in advanced disease stages. It reduces the duration and severity of poor symptom response episodes in fluctuating patients. Preliminary results allow discussion of putative effects of rasagiline on some non-motor signs and disease progression. This article outlines the evidence surrounding the efficacy and safety of rasagiline, and discusses its potential to address some of the currently unmet needs of Parkinson's disease therapy.

Preliminary efficacy of group medical nutrition therapy and motivational interviewing among obese African American women with type 2 diabetes: a pilot study.

PubMed

Miller, Stephania T; Oates, Veronica J; Brooks, Malinda A; Shintani, Ayumi; Gebretsadik, Tebeb; Jenkins, Darlene M

2014-01-01

To assess the efficacy and acceptability of a group medical nutritional therapy (MNT) intervention, using motivational interviewing (MI). RESEARCH DESIGN & METHOD: African American (AA) women with type 2 diabetes (T2D) participated in five, certified diabetes educator/dietitian-facilitated intervention sessions targeting carbohydrate, fat, and fruit/vegetable intake and management. Motivation-based activities centered on exploration of dietary ambivalence and the relationships between diet and personal strengths. Repeated pre- and post-intervention, psychosocial, dietary self-care, and clinical outcomes were collected and analyzed using generalized least squares regression. An acceptability assessment was administered after intervention. Participants (n = 24) were mostly of middle age (mean age 50.8 ± 6.3) with an average BMI of 39 ± 6.5. Compared to a gradual pre-intervention loss of HbA1c control and confidence in choosing restaurant foods, a significant post-intervention improvement in HbA1c (P = 0.03) and a near significant (P = 0.06) increase in confidence in choosing restaurant foods were observed with both returning to pre-intervention levels. 100% reported that they would recommend the study to other AA women with type 2 diabetes. The results support the potential efficacy of a group MNT/MI intervention in improving glycemic control and dietary self-care-related confidence in overweight/obese AA women with type 2 diabetes.

Relationship among practice change, motivation, and self-efficacy.

PubMed

Williams, Betsy W; Kessler, Harold A; Williams, Michael V

2014-01-01

The relationship between an individual's sense of self-efficacy, motivation to change, and the implementation of improvement programs has been reported. This research reports the relationship among self-efficacy, motivation to change, and intent to implement continuing medical education (CME) activity learnings. The measure of individual sense of self-efficacy was a 4-item scale. The measure of motivation was a 4-item scale following on the work of Johnson, et al. The self-efficacy scale has been confirmed for structure, and together the 2 scales provide indicators of 3 underlying variables-2 self-efficacy constructs and a motivation variable. In addition, a global intent to implement measure was collected. Preliminary analysis demonstrates a significant relationship between a self-efficacy construct, the motivation to change construct, and global intent to change. Specifically, the sense of efficacy in effecting change in the practice environment is predictive of a high level of motivation to change, which, in turn, is predictive of formation of an intent to change practice patterns. Further inspection of the motivation to change construct suggests that it mediates the self-efficacy constructs' effect on intent. This is consistent with an earlier report on the relationship among self-efficacy, barriers to change, and stated intent. This new finding suggests that the proximal construct motivation completely masks an important underlying causal relationship that appears to contribute to practice change following CME: self-efficacy. A focus on the participants' sense of self-agency may provide a path to practice change. © 2014 The Alliance for Continuing Education in the Health Professions, the Society for Academic Continuing Medical Education, and the Council on Continuing Medical Education, Association for Hospital Medical Education.

Therapy of the burnout syndrome.

PubMed

Korczak, Dieter; Wastian, Monika; Schneider, Michael

2012-01-01

The prevalence, diagnostics and therapy of the burnout syndrome are increasingly discussed in the public. The unclear definition and diagnostics of the burnout syndrome are scientifically criticized. There are several therapies with unclear evidence for the treatment of burnout in existence. The health technology assessment (HTA) report deals with the question of usage and efficacy of different burnout therapies. For the years 2006 to 2011, a systematic literature research was done in 31 electronic databases (e.g. EMBASE, MEDLINE, PsycINFO). Important inclusion criteria are burnout, therapeutic intervention and treatment outcome. 17 studies meet the inclusion criteria and are regarded for the HTA report. The studies are very heterogeneous (sample size, type of intervention, measuring method, level of evidence). Due to their study design (e.g. four reviews, eight randomized controlled trials) the studies have a comparable high evidence: three times 1A, five times 1B, one time 2A, two times 2B and six times 4. 13 of the 17 studies are dealing with the efficacy of psychotherapy and psychosocial interventions for the reduction of burnout (partly in combination with other techniques). Cognitive behaviour therapy leads to the improvement of emotional exhaustion in the majority of the studies. The evidence is inconsistent for the efficacy of stress management and music therapy. Two studies regarding the efficacy of Qigong therapy do not deliver a distinct result. One study proves the efficacy of roots of Rhodiola rosea (evidence level 1B). Physical therapy is only in one study separately examined and does not show a better result than standard therapy. Despite the number of studies with high evidence the results for the efficacy of burnout therapies are preliminary and do have only limited reach. The authors of the studies complain about the low number of skilled studies for the therapy of burnout. Furthermore, they point to the insufficient evaluation of the therapy studies and the need for further research. Some authors report the effects of considerable natural recovering. Numerous limitations affect the quality of the results. Intervention contents and duration, study design and study size are very diverse and do not permit direct comparison. Most of the samples are small by size with low statistical power, long-term follow-ups are missing. Comorbidities and parallel utilized therapies are insufficient documented or controlled. Most of the studies use the Maslach Burnout Inventory (MBI) as diagnostic or outcome-tool, but with different cut-off-points. It should be noticed that the validity of the MBI as diagnostic tool is not proved. Ethical, juridical and social determining factors are not covered or discussed in the studies. The efficacy of therapies for the treatment of the burnout syndrome is insufficient investigated. Only for cognitive behavioural therapy (CBT) exists an adequate number of studies which prove its efficacy. Big long-term experimental studies are missing which compare the efficacy of the single therapies and evaluate their evidence. The natural recovering without any therapy needs further research. Additionally, it has to be examined to what extent therapies and their possible effects are thwarted by the conditions of the working place and the working conditions.

The Welfare Consequences and Efficacy of Training Pet Dogs with Remote Electronic Training Collars in Comparison to Reward Based Training

PubMed Central

Cooper, Jonathan J.; Cracknell, Nina; Hardiman, Jessica; Wright, Hannah; Mills, Daniel

2014-01-01

This study investigated the welfare consequences of training dogs in the field with manually operated electronic devices (e-collars). Following a preliminary study on 9 dogs, 63 pet dogs referred for recall related problems were assigned to one of three Groups: Treatment Group A were trained by industry approved trainers using e-collars; Control Group B trained by the same trainers but without use of e-collars; and Group C trained by members of the Association of Pet Dog Trainers, UK again without e-collar stimulation (n = 21 for each Group). Dogs received two 15 minute training sessions per day for 4–5 days. Training sessions were recorded on video for behavioural analysis. Saliva and urine were collected to assay for cortisol over the training period. During preliminary studies there were negative changes in dogs' behaviour on application of electric stimuli, and elevated cortisol post-stimulation. These dogs had generally experienced high intensity stimuli without pre-warning cues during training. In contrast, in the subsequent larger, controlled study, trainers used lower settings with a pre-warning function and behavioural responses were less marked. Nevertheless, Group A dogs spent significantly more time tense, yawned more often and engaged in less environmental interaction than Group C dogs. There was no difference in urinary corticosteroids between Groups. Salivary cortisol in Group A dogs was not significantly different from that in Group B or Group C, though Group C dogs showed higher measures than Group B throughout sampling. Following training 92% of owners reported improvements in their dog's referred behaviour, and there was no significant difference in reported efficacy across Groups. Owners of dogs trained using e-collars were less confident of applying the training approach demonstrated. These findings suggest that there is no consistent benefit to be gained from e-collar training but greater welfare concerns compared with positive reward based training. PMID:25184218

Concept mapping to promote meaningful learning, help relate theory to practice and improve learning self-efficacy in Asian mental health nursing students: A mixed-methods pilot study.

PubMed

Bressington, Daniel T; Wong, Wai-Kit; Lam, Kar Kei Claire; Chien, Wai Tong

2018-01-01

Student nurses are provided with a great deal of knowledge within university, but they can find it difficult to relate theory to nursing practice. This study aimed to test the appropriateness and feasibility of assessing Novak's concept mapping as an educational strategy to strengthen the theory-practice link, encourage meaningful learning and enhance learning self-efficacy in nursing students. This pilot study utilised a mixed-methods quasi-experimental design. The study was conducted in a University school of Nursing in Hong Kong. A total of 40 third-year pre-registration Asian mental health nursing students completed the study; 12 in the concept mapping (CM) group and 28 in the usual teaching methods (UTM) group. The impact of concept mapping was evaluated thorough analysis of quantitative changes in students' learning self-efficacy, analysis of the structure and contents of the concept maps (CM group), a quantitative measure of students' opinions about their reflective learning activities and content analysis of qualitative data from reflective written accounts (CM group). There were no significant differences in self-reported learning self-efficacy between the two groups (p=0.38). The concept mapping helped students identify their current level of understanding, but the increased awareness may cause an initial drop in learning self-efficacy. The results highlight that most CM students were able to demonstrate meaningful learning and perceived that concept mapping was a useful reflective learning strategy to help them to link theory and practice. The results provide preliminary evidence that the concept mapping approach can be useful to help mental health nursing students visualise their learning progress and encourage the integration of theoretical knowledge with clinical knowledge. Combining concept mapping data with quantitative measures and qualitative reflective journal data appears to be a useful way of assessing and understanding the effectiveness of concept mapping. Future studies should utilise a larger sample size and consider using the approach as a targeted intervention immediately before and during clinical learning placements. Copyright © 2017 Elsevier Ltd. All rights reserved.

PROTECT: A Pilot Program to Integrate Mental Health Treatment Into Elder Abuse Services for Older Women.

PubMed

Sirey, Jo Anne; Halkett, Ashley; Chambers, Stephanie; Salamone, Aurora; Bruce, Martha L; Raue, Patrick J; Berman, Jacquelin

2015-01-01

The goal of this pilot program was to test the usefulness of adapted Problem-Solving Therapy (PST) and anxiety management, called PROTECT, integrated into elder abuse services to reduce depression and improve self-efficacy. Depressed women victims were randomized to receive elder abuse resolution services combined with either PROTECT or a mental health referral. At follow-up, the PROTECT group showed greater reduction in depressive symptoms and endorsed greater improved self-efficacy in problem-solving when compared to those in the Referral condition. These preliminary findings support the potential usefulness of PROTECT to alleviate depressive symptoms and enhance personal resources among abused older women.

Preliminary data on validity of the Drug Addiction Treatment Efficacy Questionnaire.

PubMed

Kastelic, Andrej; Mlakar, Janez; Pregelj, Peter

2013-09-01

This study describes the validation process for the Slovenian version of the Drug Addiction Treatment Efficacy Questionnaire (DATEQ). DATEQ was constructed from the questionnaires used at the Centre for the Treatment of Drug Addiction, Ljubljana University Psychiatric Hospital, and within the network of Centres for the Prevention and Treatment of Drug Addiction in Slovenia during the past 14 years. The Slovenian version of the DATEQ was translated to English using the 'forward-backward' procedure by its authors and their co-workers. The validation process included 100 male and female patients with established addiction to illicit drugs who had been prescribed opioid substitution therapy. The DATEQ questionnaire was used in the study, together with clinical evaluation to measure psychological state and to evaluate the efficacy of treatment in the last year. To determinate the validity of DATEQ the correlation with the clinical assessments of the outcome was calculated using one-way ANOVA. The F value was 44.4, p<0.001 (sum of squares: between groups 210.4, df=2, within groups 229.7, df=97, total 440.1, df=99). At the cut-off 4 the sensitivity is 81% and specificity 83%. The validation process for the Slovenian DATEQ version shows metric properties similar to those found in international studies of similar questionnaires, suggesting that it measures the same constructs, in the same way and as similar questionnaires. However, the relatively low sensitivity and specificity suggests caution when using DATEQ as the only measure of outcome.

Preparing mental health professionals for new directions in mental health practice: Evaluating the sensory approaches e-learning training package.

PubMed

Meredith, Pamela; Yeates, Harriet; Greaves, Amanda; Taylor, Michelle; Slattery, Maddy; Charters, Michelle; Hill, Melissa

2018-02-01

The application of sensory modulation approaches in mental health settings is growing in recognition internationally. However, a number of barriers have been identified as limiting the implementation of the approach, including workplace culture and a lack of accessible and effective sensory approaches training. The aim of this project was to investigate the efficacy of providing this training through a custom-designed e-learning package. Participants in the present study were predominately nurses and occupational therapists working in mental health settings in Queensland, Australia. Data were collected from 121 participants using an online survey. Significant improvements were found between pre- and post-training in participants' real and perceived levels of knowledge, their perceived levels of confidence, and their attitudes towards using sensory modulation approaches in mental health settings. The findings of the study suggest that the custom-designed sensory approaches e-learning package is an effective, accessible, acceptable, and usable method to train health professionals in sensory modulation approaches. As this study is the first to analyse the efficacy of an e-learning sensory approaches package, the results are considered preliminary, and further investigation is required. © 2017 Australian College of Mental Health Nurses Inc.

The effects of actors vocal exercises for relaxation on fluency: A preliminary study.

PubMed

Monteagudo, Emily; Sawyer, Jean; Sivek-Eskra, Alyssa

2017-12-01

To determine the efficacy of treatment based on Kristin Linklater's technique for vocal preparation for performance for use with people who stutter. A protocol for a treatment for stuttering involving breathing exercises, relaxation techniques, and focus on awareness was designed by the first author from Linklater's published exercises in her book Freeing the Natural Voice (2006). Four adults who stutter participated in a 12-week, single-case reversal design study. Treatment efficacy was determined by baseline and post-treatment measures on the OASES, self-report naturalness, tension and severity scale, and percentage of stuttering-like disfluency (SLD). Qualitative measures included a daily tension and practice log, a program completion questionnaire, and accounts from the clinicians administering the treatment protocol. Three of four participants scored lower on the OASES post-treatment, suggesting that the impact of stuttering on their daily lives had decreased. All four experienced a reduction in the number of SLD counted throughout treatment sessions compared to baseline data. A treatment for stuttering based on Linklater's work including regulation of breathing, relaxation, and awareness of breath may be effective in improving fluency and decreasing the impact of stuttering and warrants further study. Copyright © 2017 Elsevier Inc. All rights reserved.

Review of transcranial photobiomodulation for major depressive disorder: targeting brain metabolism, inflammation, oxidative stress, and neurogenesis

PubMed Central

Cassano, Paolo; Petrie, Samuel R.; Hamblin, Michael R.; Henderson, Theodore A.; Iosifescu, Dan V.

2016-01-01

Abstract. We examined the use of near-infrared and red radiation (photobiomodulation, PBM) for treating major depressive disorder (MDD). While still experimental, preliminary data on the use of PBM for brain disorders are promising. PBM is low-cost with potential for wide dissemination; further research on PBM is sorely needed. We found clinical and preclinical studies via PubMed search (2015), using the following keywords: “near-infrared radiation,” “NIR,” “low-level light therapy,” “low-level laser therapy,” or “LLLT” plus “depression.” We chose clinically focused studies and excluded studies involving near-infrared spectroscopy. In addition, we used PubMed to find articles that examine the link between PBM and relevant biological processes including metabolism, inflammation, oxidative stress, and neurogenesis. Studies suggest the processes aforementioned are potentially effective targets for PBM to treat depression. There is also clinical preliminary evidence suggesting the efficacy of PBM in treating MDD, and comorbid anxiety disorders, suicidal ideation, and traumatic brain injury. Based on the data collected to date, PBM appears to be a promising treatment for depression that is safe and well-tolerated. However, large randomized controlled trials are still needed to establish the safety and effectiveness of this new treatment for MDD. PMID:26989758

An Online Learning Module to Increase Self-Efficacy and Involvement in Care for Patients With Advanced Lung Cancer: Research Protocol.

PubMed

Janssen, Anna; Shaw, Tim; Nagrial, Adnan; Pene, Christopher; Rabbets, Melanie; Carlino, Matteo; Zachulski, Clare; Phillips, Jane; Birnbaum, Robert; Gandhi, Tejal; Harnett, Paul

2016-08-08

Improving patient care for individuals with lung cancer is a priority due to the increasing burden of the disease globally. One way this can be done is by improving patient self-management capabilities through increasing their self-efficacy. This can improve positive outcomes for patients with chronic conditions and increase their ability to manage the challenges of such illnesses. Unfortunately, patients with chronic conditions often struggle to travel far from home to engage with patient education events, a common means of improving self-efficacy. The development of more accessible tools for improving patient self-efficacy is required to increase quality of life for patients with chronic conditions. To evaluate the feasibility of delivering symptom identification and management information to patients with advanced lung cancer using an online program. This article describes a pre-post test study to evaluate a Qstream online learning platform to improve patient self-efficacy for managing advanced lung cancer symptoms. Undertaking this program should increase participant knowledge about the side-effects they may experience as a result of their treatment and in turn increase help-seeking behavior and self-efficacy for the participant cohort. Quantitative data collected by the Qstream platform on the completion rates of participants will be used as a tool to evaluate the intervention. Additionally, validated scales will be used to collect data on patient self-efficacy. Qualitative data will also be collected via an exit survey and thematic content analysis of semi-structured interviews. The research is in the preliminary stages but thus far a protocol has been approved in support of the project. Additionally, advisory committee members have been identified and initial meetings have been undertaken. Development of new approaches for increasing patient understanding of their care is important to ensure high quality care continues to be delivered in the clinical setting.

Telehealth delivery of cognitive-behavioral intervention to youth with autism spectrum disorder and anxiety: A pilot study

PubMed Central

Hepburn, Susan L; Blakeley-Smith, Audrey; Wolff, Brian; Reaven, Judy A

2015-01-01

Youth with autism spectrum disorders frequently experience significant symptoms of anxiety. Empirically supported psychosocial interventions exist, yet access is limited, especially for families in rural areas. Telehealth (i.e. videoconferencing) has potential to reduce barriers to access to care; however, little is known about the feasibility or efficacy of directly intervening with youth with autism spectrum disorders through this modality. This study details the pilot testing of a telehealth version of an empirically supported intervention targeting anxiety in youth with autism spectrum disorders. The primary focus of this study is on feasibility, with evaluation of outcomes as a starting point for future randomized trials. In all, 33 families of youth with autism spectrum disorders and significant anxiety symptoms participated in this study (Telehealth Facing Your Fears (FYF) Intervention: n = 17; Wait-list control: n = 16). Youth of all functioning levels were included. Acceptability was strong; however, the usability of the technology was problematic for some families and impeded some sessions significantly. Fidelity of the telehealth version to the critical elements of the original, in vivo version was excellent. More work is needed to improve delivery of exposure practices and parent coaching. Preliminary efficacy analyses are promising, with improvements observed in youth anxiety over time (relative to a comparison group waiting for live intervention) and parent sense of competence (within group). Clearly, stronger designs are necessary to evaluate efficacy sufficiently; however, this study does provide support for further investigation of clinic-to-home videoconferencing as a direct intervention tool for youth with autism spectrum disorders and their parents. PMID:25896267

Telehealth delivery of cognitive-behavioral intervention to youth with autism spectrum disorder and anxiety: A pilot study.

PubMed

Hepburn, Susan L; Blakeley-Smith, Audrey; Wolff, Brian; Reaven, Judy A

2016-02-01

Youth with autism spectrum disorders frequently experience significant symptoms of anxiety. Empirically supported psychosocial interventions exist, yet access is limited, especially for families in rural areas. Telehealth (i.e. videoconferencing) has potential to reduce barriers to access to care; however, little is known about the feasibility or efficacy of directly intervening with youth with autism spectrum disorders through this modality. This study details the pilot testing of a telehealth version of an empirically supported intervention targeting anxiety in youth with autism spectrum disorders. The primary focus of this study is on feasibility, with evaluation of outcomes as a starting point for future randomized trials. In all, 33 families of youth with autism spectrum disorders and significant anxiety symptoms participated in this study (Telehealth Facing Your Fears (FYF) Intervention: n = 17; Wait-list control: n = 16). Youth of all functioning levels were included. Acceptability was strong; however, the usability of the technology was problematic for some families and impeded some sessions significantly. Fidelity of the telehealth version to the critical elements of the original, in vivo version was excellent. More work is needed to improve delivery of exposure practices and parent coaching. Preliminary efficacy analyses are promising, with improvements observed in youth anxiety over time (relative to a comparison group waiting for live intervention) and parent sense of competence (within group). Clearly, stronger designs are necessary to evaluate efficacy sufficiently; however, this study does provide support for further investigation of clinic-to-home videoconferencing as a direct intervention tool for youth with autism spectrum disorders and their parents. © The Author(s) 2015.

Managing Acute Behavioural Disturbances in the Emergency Department Using the Environment, Policies and Practices: A Systematic Review.

PubMed

Weiland, Tracey J; Ivory, Sean; Hutton, Jennie

2017-06-01

Effective strategies for managing acute behavioural disturbances (ABDs) within emergency departments (EDs) are needed given their rising occurrence and negative impact on safety, psychological wellbeing, and staff turnover. Non-pharmacological interventions for ABD management generally fall into four categories: environmental modifications; policies; practice changes; and education. Our objective was to systematically review the efficacy of strategies for ABD management within EDs that involved changes to environment, architecture, policy and practice. We performed systematic searches of CINAHL Plus with Full Text, PsycINFO, MEDLINE, and EMBASE, as well as reference lists of relevant review articles to identify relevant studies published between January 1985 - April 2016. We included studies written in English, which reported management of behavioural disturbances in adults associated with the ED through the use of environmental modifiers (including seclusion, restraint, specialised rooms, architectural changes), policy, and practice-based interventions excepting education-only interventions. Efficacy outcomes of interest included incidence, severity, and duration of ABD, incidence of injuries, staff absenteeism, restraint use, restraint duration, and staff and patient perceptions. Two reviewers independently screened titles and abstracts, and assessed the relevancy and eligibility of studies based on full-text articles. Two authors independently appraised included studies. A narrative synthesis of findings was undertaken. Studies reporting interventions for managing ABDs within the ED are limited in number and quality. The level of evidence for efficacy is low, requiring caution in conclusions. While there is preliminary evidence for environmental change in the form of specialised behavioural rooms, security upgrades and ED modifications, these are not supported by evidence from controlled studies. Many of these "common sense" environmental changes recommended in many guidelines have been widely implemented in EDs. There is an unambiguous gap in the literature regarding the efficacy of interventions for ABD management in EDs involving environmental, policy or practice-based changes. With growing demand on EDs, and with increasing numbers of ABDs, identification of robust evidence-based interventions for safe and effective ABD management is vital.

"Family Matters": A Systematic Review of the Evidence For Family Psychoeducation For Major Depressive Disorder.

PubMed

Brady, Pamela; Kangas, Maria; McGill, Katherine

2017-04-01

The first aim of this systematic review was to evaluate the evidence for family psychoeducation (FPE) interventions for major depressive disorder (MDD). A second aim was to compare the efficacy of different modes of delivering face-to-face FPE interventions. Ten studies (based on nine distinct samples) were identified comprising four single-family studies, four multifamily studies, one single versus multifamily comparative study, and one peer-led, mixed-diagnosis study. Seven studies measured patient functioning and six reported positive outcomes. Six studies measured carer's well-being and four reported positive outcomes. Results provide preliminary evidence that FPE leads to improved outcomes for patient functioning and family-carer's well-being for persons with depression. The implications for future development and delivery of FPE interventions for MDD are discussed. © 2016 American Association for Marriage and Family Therapy.

Antivenom for Neuromuscular Paralysis Resulting From Snake Envenoming

PubMed Central

Silva, Anjana; Hodgson, Wayne C.; Isbister, Geoffrey K.

2017-01-01

Antivenom therapy is currently the standard practice for treating neuromuscular dysfunction in snake envenoming. We reviewed the clinical and experimental evidence-base for the efficacy and effectiveness of antivenom in snakebite neurotoxicity. The main site of snake neurotoxins is the neuromuscular junction, and the majority are either: (1) pre-synaptic neurotoxins irreversibly damaging the presynaptic terminal; or (2) post-synaptic neurotoxins that bind to the nicotinic acetylcholine receptor. Pre-clinical tests of antivenom efficacy for neurotoxicity include rodent lethality tests, which are problematic, and in vitro pharmacological tests such as nerve-muscle preparation studies, that appear to provide more clinically meaningful information. We searched MEDLINE (from 1946) and EMBASE (from 1947) until March 2017 for clinical studies. The search yielded no randomised placebo-controlled trials of antivenom for neuromuscular dysfunction. There were several randomised and non-randomised comparative trials that compared two or more doses of the same or different antivenom, and numerous cohort studies and case reports. The majority of studies available had deficiencies including poor case definition, poor study design, small sample size or no objective measures of paralysis. A number of studies demonstrated the efficacy of antivenom in human envenoming by clearing circulating venom. Studies of snakes with primarily pre-synaptic neurotoxins, such as kraits (Bungarus spp.) and taipans (Oxyuranus spp.) suggest that antivenom does not reverse established neurotoxicity, but early administration may be associated with decreased severity or prevent neurotoxicity. Small studies of snakes with mainly post-synaptic neurotoxins, including some cobra species (Naja spp.), provide preliminary evidence that neurotoxicity may be reversed with antivenom, but placebo controlled studies with objective outcome measures are required to confirm this. PMID:28422078

Stepping Stones Triple P: An RCT of a Parenting Program with Parents of a Child Diagnosed with an Autism Spectrum Disorder

ERIC Educational Resources Information Center

Whittingham, Koa; Sofronoff, Kate; Sheffield, Jeanie; Sanders, Matthew R.

2009-01-01

Whilst the Triple P Positive Parenting Program has a large evidence base (Sanders, "Clinical Child and Family Psychology Review" 2:71-90, 1999; Sanders, "Journal of Consulting and Clinical Psychology" 68:624-640, 2000) and preliminary evidence indicates that Stepping Stones Triple P is also efficacious (Roberts, "Journal of Clinical Child and…

Preliminary study of efficacy of dynamic compression system in the correction of typical pectus carinatum.

PubMed

Lopez, Manuel; Patoir, Arnaud; Varlet, François; Perez-Etchepare, Eduardo; Tiffet, Théophile; Villard, Aurelien; Tiffet, Olivier

2013-11-01

This preliminary study evaluates, by qualitative score, the efficacy of the dynamic compression system (DCS) with a pressure-measuring device in the treatment of pectus carinatum (PC) as an alternative to surgery. A total of 68 patients (infants, adolescents and young adults) presenting with typical PC (64 males and 4 females) were evaluated in our Chest Wall Deformities Unit, between October 2011 and February 2013. The criteria for including subjects were: patients with typical condrogladiolar PC and pressure for initial correction (PIC) ≤ 9 PSI (pound square inch). Seven patients were excluded in this study: three typical PC were treated by minimal invasive surgery (Abramson technique) due to highly elevated PIC and four atypical PC, hybrids forms (PE and PC) were treated by cup suction for pectus excavatum and by the DCS for the PC. The management protocol included: adjustment of the DCS, strengthening exercises and monthly clinical follow-up. The partial and final results were evaluated by the patients, by their parents or by both, using a qualitative scoring scale that was measured in a three-step grading system, where C is a low or very low result, B is acceptable and A is a very good or excellent result. A total of 61 patients (59 males and 2 females) presenting with typical PC were treated by the DCS and included: symmetric PC in 43 cases and asymmetric PC in 18 cases. The mean age was 13.5 years (5-25). The mean PIC was 6.3 PSI (3-9 PSI). The mean utilization time was 19 h daily. The patients were divided into three groups. In Group I, consisting of 35 cases, all the patients have already completed the treatment with excellent aesthetic results (A). In 12 cases, Group II, the normal shape of the thorax has been obtained; all the patients in this group rated their results as excellent (A); however, these patients are still wearing the brace as a retainer for 3 additional months. Fourteen patients, Group III, are progressing and improving under active treatment, and surgeons and patients are very satisfied with the initial results. None of the 61 patients in this study abandoned the treatment and no complications were found. This preliminary study demonstrated that the DCS with a pressure-measuring device is a minimal invasive system effective for treatment of PC in patients where the anterior chest wall is still compliant. The control of different pressure measurements could be used as the inclusion criterion as well as a predictive factor for aesthetic results and treatment duration.

Trial of infographics in Northern Ireland (TINI): Preliminary evaluation and results of a randomized controlled trial comparing infographics with text.

PubMed

McCrorie, Alan David; Chen, Jingwen Jessica; Weller, Ross; McGlade, Kieran John; Donnelly, Conan

2018-06-01

Infographics represent a potential means of improving public knowledge about cancer. However, there is little experimental evidence of their efficacy. This preliminary study investigates whether infographics are superior to text for the communication of information about cancer risk in old age via a three armed randomized controlled trial. Trial involved allocation concealment and block randomization of 30 male participants aged over 50 to receive text information (control) or one of two infographics (interventions). Participants who viewed an infographic were more likely to know the correct association between cancer risk and old age compared with those viewing text information (risk ratio = 3.0, 95% confidence interval 0.82-10.90). Participants had limited understanding of the phrases "cancer incidence" and "cancer prevalence" but good understanding of the phrases "cancer risk factor" and "cancer stage." Possession of good numerical skills appears to be a key determinant of ability to extract meaning from statistical information provided; regardless of format. Initial results suggest icon array infographics may be more effective communication mediums than text but further study with more participants and an updated infographic is necessary to confirm this finding. ISRCTN33951209.

Treatment of female pattern hair loss.

PubMed

Hassani, Masoumeh; Gorouhi, Farzam; Babakoohi, Shahab; Moghadam-Kia, Siamak; Firooz, Alireza

2012-01-01

Female pattern hair loss (FPHL) as a distinctive entity was first described about 30 years ago. The objective of this study was to perform a systematic review of all randomized controlled trials for treatment of FPHL. A preliminary search was carried out in several databases up to August 2008 to identify all randomized controlled trials on nonsurgical interventions for treatment of FPHL. Studies reporting fewer than 10 patients and non-English articles were excluded. Additionally, references of relevant articles and reviews were checked manually in search for additional sources. Among 238 citations found in the preliminary search, 12 fulfilled all criteria to be included in the systematic review. Topical minoxidil 1% to 5% for 24 to 48 weeks was shown to be effective in FPHL and its effect was not related to age or androgen level of patients. In addition, it may be effective in women with FPHL, both with and without hyperandrogenism, and in young and old premenopausal or postmenopausal. In patients with increased serum androgens, oral flutamide but not finasteride or cyproterone acetate was more effective than no treatment. Topical minoxidil is effective in patients with FPHL, with or without hyperandrogenism, but there is limited evidence for the efficacy of antiandrogens.

Trial of dextromethorphan/quinidine to treat levodopa-induced dyskinesia in Parkinson's disease.

PubMed

Fox, Susan H; Metman, Leonard Verhagen; Nutt, John G; Brodsky, Matthew; Factor, Stewart A; Lang, Anthony E; Pope, Laura E; Knowles, Nadine; Siffert, João

2017-06-01

Nondopaminergic pathways represent potential targets to treat levodopa-induced dyskinesia in Parkinson's disease (PD). This pilot-study (NCT01767129) examined the safety/efficacy of the sigma-1 receptor-agonist and glutamatergic/monoaminergic modulator, dextromethorphan plus quinidine (to inhibit rapid dextromethorphan metabolism), for treating levodopa-induced dyskinesia. PD patients were randomized to dextromethorphan/quinidine (45 mg/10 mg twice daily)/placebo in two 2-week double-blind, crossover treatment periods, with intervening 2-week washout. After 14 days, a 2-hour intravenous levodopa-infusion was administered. Patient examinations were videotaped before infusion ("off" state) and every 30 minutes during and afterwards until patients returned to "off." The primary endpoint was dyskinesia-severity during infusion measured by Unified Dyskinesia Rating Scale part 3 area-under-curve scores (blinded expert rated). Additional endpoints included other dyskinesia/motor assessments, global measures of clinical-change, and adverse-events. A total of 13 patients were randomized and completed the study (efficacy-evaluable population). Dyskinesia-severity was nonsignificantly lower with dextromethorphan/quinidine than placebo during infusion (area-under-curve 966.5 vs 1048.8; P = .191 [efficacy-evaluable patients]), and significantly lower in a post-hoc sensitivity analysis of the per-protocol-population (efficacy-evaluable patients with ≥ 80% study-drug-compliance, n = 12) when measured from infusion start to 4-hours post-infusion completion (area-under-curve 1585.0 vs 1911.3; P = .024). Mean peak dyskinesia decreased significantly from infusion-start to return to "off" (13.3 vs 14.9; P = .018 [efficacy-evaluable patients]). A total of 9 patients rated dyskinesia "much/very much improved" on dextromethorphan/quinidine versus 1-patient on placebo. Dextromethorphan/quinidine did not worsen PD-motor scores, was generally well tolerated, and was associated with more frequent adverse events. This study provides preliminary evidence of clinical benefit with dextromethorphan/quinidine for treating levodopa-induced dyskinesia in PD. Larger studies with a longer treatment duration need to corroborate these early findings. © 2017 International Parkinson and Movement Disorder Society. © 2017 International Parkinson and Movement Disorder Society.

Preliminary efficacy investigations of oral fipronil against Anopheles arabiensis when administered to Zebu cattle (Bos indicus) under field conditions.

PubMed

Poché, Richard M; Githaka, Naftaly; van Gool, Frans; Kading, Rebekah C; Hartman, Daniel; Polyakova, Larisa; Abworo, Edward Okoth; Nene, Vishvanath; Lozano-Fuentes, Saul

2017-12-01

Globally, malaria remains one of the most important vector-borne diseases despite the extensive use of vector control, including indoor residual spraying (IRS) and insecticide-treated nets (ITNs). These control methods target endophagic vectors, whereas some malaria vectors, such as Anopheles arabiensis, preferentially feed outdoors on cattle, making it a complicated vector to control using conventional strategies. Our study evaluated whether treating cattle with a capsule containing the active ingredient (AI) fipronil could reduce vector density and sporozoite rates, and alter blood feeding behavior, when applied in a small-scale field study. A pilot field study was carried out in the Samia District, Western Kenya, from May to July 2015. Four plots, each comprised of 50 huts used for sleeping, were randomly designated to serve as control or treatment. A week before cattle treatment, baseline mosquito collections were performed inside the houses using mechanical aspirators. Animals in the treatment (and buffer) were administered a single oral application of fipronil at ∼0.5mg/kg of body weight. Indoor mosquito collections were performed once a week for four weeks following treatment. Female mosquitoes were first identified morphologically to species complex, followed by PCR-based methods to obtain species identity, sporozoite presence, and the host source of the blood meal. All three species of anophelines found in the study area (An. gambiae s.s., An. arabiensis, An. funestus s.s.) were actively transmitting Plasmodium falciparum during the study period. The indoor resting density of An. arabiensis was significantly reduced in treatment plot one at three weeks post-treatment (T1) (efficacy=89%; T1 density=0.08, 95% credibility intervals [0.05, 0.10]; control plot density=0.78 [0.22, 0.29]) and at four weeks post-treatment (efficacy=64%; T1 density=0.16 [0.08, 0.14]; control plot density=0.48 [0.17, 0.22]). The reduction of An. arabiensis mosquitoes captured in the treatment plot two was higher: zero females were collected after treatment. The indoor resting density of An. gambiae s.s. was not significantly different between the treatment (T1, T2) and their corresponding control plots (C1, C2). An. funestus s.s. showed an increase in density over time. The results of this preliminary study suggest that treating cattle orally with fipronil, to target exophagic and zoophagic malaria vectors, could be a valuable control strategy to supplement existing vector control interventions which target endophilic anthropophilic species. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Group-Based Yogic Weight Loss with Ayurveda-Inspired Components: A Pilot Investigation of Female Yoga Practitioners and Novices.

PubMed

Braun, Tosca D; Park, Crystal L; Gorin, Amy A; Garivaltis, Hilary; Noggle, Jessica J; Conboy, Lisa A

2016-01-01

Overweight/obesity is a pressing international health concern and conventional treatments demonstrate poor long-term efficacy. Preliminary evidence suggests yoga and Ayurveda may be promising approaches, although recent NHIS estimates indicate rare utilization of Ayurveda in the US. Group-based curricula that integrate yoga and Ayurveda-inspired principles to attenuate overweight and obesity across individuals may prove a feasible, disseminable clinical adjunct to facilitate psychosocial health and weight loss and/or maintenance. Determine feasibility and preliminary effectiveness of a ten-week yoga - based, Ayurveda-inspired weight management curriculum (YWL) piloted in female yoga practitioners (Study 1) then refined and tailored for yoga naïves (Study 2), on self-reported psychosocial process variables and % of self-reported total body weight loss (%TBWL). Study 1 enrolled 22 yoga-experienced women (48.2 ± 14.3 years, BMI 30.8 ± 4.2 kg/m2) in a 10-week yoga-based program (YWL-YE). Study 2 enrolled 21 yoga- naïve women (49.4 ± 10.7 years, BMI 35.5 ± 6.8 kg/m2) in a revised 10-week program (YWL-YN). Self-reported weight and self-ratings of mindful eating behavior, body image disturbance, weight loss self-efficacy, body awareness, and self-compassion were collected at baseline, post-treatment (T2), and 3-month follow- up (T3). YWL curricula was feasible in both studies. While attrition rates for both studies favorably compared to other weight management studies, attrition was higher for YWL-YN (28.6%) than YWL-YE (18.2%). In both studies, self-reported process variables and self-reported % TBWL changed in hypothesized directions at T2 and evidenced greater improvement at T3; effect sizes across all process variables were medium (-0.4) to large (-1.8). % TBWL reached clinical significance (>5%) only at T3 for the YWL-YE group. The YWL curricula employed here appear to improve psychosocial health among both overweight/obese yoga-experienced and yoga- naïve women. Results must be interpreted with caution due to study design, self-report assessments, and other limitations. Nonetheless, hypotheses are generated for future investigation.

Group-Based Yogic Weight Loss with Ayurveda-Inspired Components: A Pilot Investigation of Female Yoga Practitioners and Novices.

PubMed

Braun, Tosca D; Park, Crystal L; Gorin, Amy A; Garivaltis, Hilary; Noggle, Jessica J; Conboy, Lisa A

2016-09-01

Overweight/obesity is a pressing international health concern and conventional treatments demonstrate poor long-term efficacy. Preliminary evidence suggests yoga and Ayurveda may be promising approaches, although recent NHIS estimates indicate rare utilization of Ayurveda in the US. Group-based curricula that integrate yoga and Ayurveda-inspired principles to attenuate overweight and obesity across individuals may prove a feasible, disseminable clinical adjunct to facilitate psychosocial health and weight loss and/or maintenance. Determine feasibility and preliminary effectiveness of a ten-week yoga-based, Ayurveda-inspired weight management curriculum (YWL) piloted in female yoga practitioners (Study 1) then refined and tailored for yoga naïves (Study 2), on self-reported psychosocial process variables and % of self-reported total body weight loss (%TBWL). Study 1 enrolled 22 yoga-experienced women (48.2 ± 14.3 years, BMI 30.8 ± 4.2 kg/m2) in a 10-week yoga-based program (YWL-YE). Study 2 enrolled 21 yoga- naïve women (49.4 ± 10.7 years, BMI 35.5 ± 6.8 kg/m2) in a revised 10-week program (YWL-YN). Self-reported weight and self-ratings of mindful eating behavior, body image disturbance, weight loss self-efficacy, body awareness, and self-compassion were collected at baseline, post-treatment (T2), and 3-month follow- up (T3). YWL curricula was feasible in both studies. While attrition rates for both studies favorably compared to other weight management studies, attrition was higher for YWL-YN (28.6%) than YWL-YE (18.2%). In both studies, self-reported process variables and self-reported % TBWL changed in hypothesized directions at T2 and evidenced greater improvement at T3; effect sizes across all process variables were medium (-0.4) to large (-1.8). % TBWL reached clinical significance (>5%) only at T3 for the YWL-YE group. The YWL curricula employed here appear to improve psychosocial health among both overweight/obese yoga-experienced and yoga-naïve women. Results must be interpreted with caution due to study design, self-report assessments, and other limitations. Nonetheless, hypotheses are generated for future investigation.

Evaluating Parents' Self-Efficacy for Diabetes Management in Pediatric Type 1 Diabetes.

PubMed

Noser, Amy E; Patton, Susana R; Van Allen, Jason; Nelson, Michael B; Clements, Mark A

2017-04-01

To examine the factor structure and construct validity of the Maternal Self-Efficacy for Diabetes Management Scale (MSED) in 135 youth ( Mage  = 13.50  ±  1.83 years), with type 1 diabetes mellitus. The study used exploratory factor analysis (EFA) to examine the factor structure and correlations to examine relationships among MSED factors and select parent and child diabetes-related health behaviors and outcomes. EFA identified an 11-item three-factor solution (χ 2 (25, n  = 133)  = 40.22, p  < .03, RMSEA = 0.07, CFI = 0.98, TLI = 0.97), with factors corresponding to parents' perceived ability to manage their child's diabetes (MSED-M), problem-solve issues surrounding glycemic control (MSED-P), and teach their child about diabetes care (MSED-T). Correlational analyses revealed significant associations between the MSED-M and MSED-T and parent-reported optimism and youth's diabetes-specific self-efficacy. The MSED-T was also associated with glycated hemoglobin and self-monitoring blood glucose. Results provide preliminary evidence for the reliability and validity of a three-factor solution of the MSED. © The Author 2016. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

[New questionnaire to assess self-efficacy toward physical activity in children].

PubMed

Aedo, Angeles; Avila, Héctor

2009-10-01

To design a questionnaire for assessment of self-efficacy toward physical activity in school children, as well as to measure its construct validity, test-retest reliability, and internal consistency. A four-stage multimethod approach was used: (1) bibliographic research followed by exploratory study and the formulation of questions and responses based on a dichotomous scale of 14 items; (2) validation of the content by a panel of experts; (3) application of the preliminary version of the questionnaire to a sample of 900 school-aged children in Mexico City; and (4) determination of the construct validity, test-retest reliability, and internal consistency (Cronbach's alpha). Three factors were identified that explain 64.15% of the variance: the search for positive alternatives to physical activity, ability to deal with possible barriers to exercising, and expectations of skill or competence. The model was validated using the goodness of fit, and the result of 65% less than 0.05 indicated that the estimated factor model fit the data. Cronbach's consistency alpha was 0.733; test-retest reliability was 0.867. The scale designed has adequate reliability and validity. These results are a good indicator of self-efficacy toward physical activity in school children, which is important when developing programs intended to promote such behavior in this age group.

Reporting, Visualization, and Modeling of Immunogenicity Data to Assess Its Impact on Pharmacokinetics, Efficacy, and Safety of Monoclonal Antibodies.

PubMed

Passey, Chaitali; Suryawanshi, Satyendra; Sanghavi, Kinjal; Gupta, Manish

2018-02-26

The rapidly increasing number of therapeutic biologics in development has led to a growing recognition of the need for improvements in immunogenicity assessment. Published data are often inadequate to assess the impact of an antidrug antibody (ADA) on pharmacokinetics, safety, and efficacy, and enable a fully informed decision about patient management in the event of ADA development. The recent introduction of detailed regulatory guidance for industry should help address many past inadequacies in immunogenicity assessment. Nonetheless, careful analysis of gathered data and clear reporting of results are critical to a full understanding of the clinical relevance of ADAs, but have not been widely considered in published literature to date. Here, we review visualization and modeling of immunogenicity data. We present several relatively simple visualization techniques that can provide preliminary information about the kinetics and magnitude of ADA responses, and their impact on pharmacokinetics and clinical endpoints for a given therapeutic protein. We focus on individual sample- and patient-level data, which can be used to build a picture of any trends, thereby guiding analysis of the overall study population. We also discuss methods for modeling ADA data to investigate the impact of immunogenicity on pharmacokinetics, efficacy, and safety.

A pilot study investigating the effects of trauma, experiential avoidance, and disease management in HIV-positive MSM using methamphetamine.

PubMed

Chartier, Maggie; Vinatieri, Trisha; Delonga, Kathryn; McGlynn, Lawrence M; Gore-Felton, Cheryl; Koopman, Cheryl

2010-01-01

With high rates of trauma among HIV-positive men who have sex with men (MSM) who use methamphetamine, this preliminary pilot study examined the associations between experiential avoidance, trauma symptoms, and management of a chronic illness. Among a small sample of HIV-positive, methamphetamine-using MSM in a California Bay Area County, greater reported experiential avoidance was significantly related to greater reported trauma and symptoms of traumatic stress. Furthermore, greater reported experiential avoidance was significantly related to reduced self-efficacy of illness management and more frequent methamphetamine use. Although further research is needed, these data suggest that addressing issues of experiential avoidance and trauma could affect behavioral choices and treatment outcomes in this high-risk population.

Health promotion, psychological distress, and disease prevention in the workplace: a cross-sectional study of Italian adults.

PubMed

Ramaci, Tiziana; Pellerone, Monica; Ledda, Caterina; Rapisarda, Venerando

2017-01-01

Job insecurity resulting from new types of employment contracts, together with organizational dynamics such as restructuring and internationalization, is emerging as an important source of organizational and individual stress, often transforming the workplace into a hostile and, above all, extremely demanding context from a psychological point of view. The aim of this study was to identify the possible relationships between individual and organizational dimensions of work (such as engagement, autonomy, personal and collective efficacy at work, and satisfaction) and their impact on stress levels. The survey involved 120 Italian workers: 72 females (60%) and 48 males (40%), with a mean age of 41.8 years ±7.31 years. The groups of participants were selected on the basis of employment contract type (traditional or atypical) to emphasize potential differences. The study was conducted using a set of self-administered questionnaires, including the Psychological Stress Measure and Utrecht Work Engagement Scale. The data show that personal and collective efficacy at work correlates negatively with stress, which in turn correlates negatively with engagement and satisfaction. The results support the hypothesis that job insecurity could be considered a strong predictor of poor health. The study should be considered as a preliminary assessment prior to studies of broader interventions to increase quality of life.

A Preliminary Report on the CO2 Laser for Lumbar Fusion: Safety, Efficacy and Technical Considerations.

PubMed

Villavicencio, Alan T; Burneikiene, Sigita; Babuska, Jason M; Nelson, Ewell L; Mason, Alexander; Rajpal, Sharad

2015-04-01

The purpose of this study was to evaluate potential technical advantages of the CO2 laser technology in mini-open transforaminal lumbar interbody fusion (TLIF) surgeries and report our preliminary clinical data on the safety and clinical outcomes. There is currently no literature discussing the recently redeveloped CO2 laser technology application for lumbar fusion. Safety and clinical outcomes were compared between two groups: 24 patients that underwent CO2 laser-assisted one-level TLIF surgeries and 30 patients that underwent standard one-level TLIF surgeries without the laser. There were no neural thermal injuries or other intraoperative laser-related complications encountered in this cohort of patients. At a mean follow-up of 17.4 months, significantly reduced lower back pain scores (P=0.013) were reported in the laser-assisted patient group compared to a standard fusion patient group. Lower extremity radicular pain intensity scores were similar in both groups. Laser-assisted TLIF surgeries showed a tendency (P = 0.07) of shorter operative times that was not statistically significant. Based on this preliminary clinical report, the safety of the CO2 laser device for lumbar fusion surgeries was assessed. There were no neural thermal injuries or other intraoperative laser-related complications encountered in this cohort of patients. Further investigation of CO2 laser-assisted lumbar fusion procedures is warranted in order to evaluate its effect on clinical outcomes.

Preliminary experiments of a single x-ray view catheter 3D localization algorithm for targeted stem cell injections

NASA Astrophysics Data System (ADS)

Iovea, M.; Creed, J.; Perin, E.; Neagu, M.; Mateiasi, G.

2009-02-01

The aim of this study was to conduct a preliminary check of a new method for measuring the 3D catheter position based on only one X-Ray view (image) and a simple pre-calibration procedure for catheters that could be equipped with high-opacity equal-spaced markers. The application chosen for this experiment is the targeted delivery of cell based therapeutic via a transendocardial retrograde approach into the left ventricle. This approach has shown promising therapeutic retention data when injected directly into the myocardial tissue, but lacks in the ability of the user to confidently manipulate the catheter within the left ventricle cavity space under traditional fluoroscopic guidance using a needle based catheter. The need for a new technique arose from the potential for increased safety and therapeutic efficacy by improving the targeting of the agent. The new technique, destined for Image guided catheter navigation systems for cardiac interventions, is based on a measurement of the marker's size and distance between them and followed by a comparison with the referenced catheter position. Preliminary experiments made with a simple phantom are presented, emphasizing the ability of the new technique in measuring the markers and the catheter tip 3D position. An overall maximum error in positioning markers and catheter tip below 12% has been obtained, yielding a promising result for continuing the future work of improving the algorithm accuracy.

The use of atypical antipsychotics beyond psychoses: efficacy of quetiapine in bipolar disorder

PubMed Central

Mundo, Emanuela; Cattaneo, Elisabetta; Zanoni, Silvia; Altamura, A Carlo

2006-01-01

Background and rationale Atypical antpsychotics have been sucessfully used in the treatment of bipolar disorder (BD), either as adjunctive or as monotherapy. Quetiapine is an atypical antipsychotic extensively used in the treatment of psychotic disorders. It has serotonergic and dopaminergic activity and it appears to be selective for the mesolimbic and mesocortical dopamine system. The aim of this paper was to review the recent literature on the use of quetiapine in the treatment of BD. Methods The literature databases currently available online were searched for papers on quetiapine and BD. Papers and reports published between January 1995 and June 2005 were selected and reviewed critically. Results Augmentative low dose quetiapine was found to be effective in BD partially responsive to conventional mood-stabilizers. Manic and mixed episodes have been the best studied, and quetiapine was found to be effective either as monotherapy or as adjunctive therapy in both randomized clinical trials and open-label studies. Data on the use of quetiapine in bipolar depression showed a significant efficacy and high remission rates. Maintenance data suggested a role of quetiapine as a good alternative to classical mood stabilizers in reducing recurrence rates of BD. A few studies on the efficacy in rapid cycling BD have also been published. Conclusions Quetiapine is an effective agent for the short- and long-term treatment of BD. The mechanism of action of quetiapine as a mood stabilizer is still unknown. Some preliminary data suggest the involvement of glutamate pathways but further studies are needed to clarify this issue. PMID:19412458

Computer-based attention training in the schools for children with attention deficit/hyperactivity disorder: a preliminary trial.

PubMed

Steiner, Naomi J; Sheldrick, Radley Christopher; Gotthelf, David; Perrin, Ellen C

2011-07-01

Objective. This study examined the efficacy of 2 computer-based training systems to teach children with attention deficit/hyperactivity disorder (ADHD) to attend more effectively. Design/methods. A total of 41 children with ADHD from 2 middle schools were randomly assigned to receive 2 sessions a week at school of either neurofeedback (NF) or attention training through a standard computer format (SCF), either immediately or after a 6-month wait (waitlist control group). Parents, children, and teachers completed questionnaires pre- and postintervention. Results. Primary parents in the NF condition reported significant (P < .05) change on Conners's Rating Scales-Revised (CRS-R) and Behavior Assessment Scales for Children (BASC) subscales; and in the SCF condition, they reported significant (P < .05) change on the CRS-R Inattention scale and ADHD index, the BASC Attention Problems Scale, and on the Behavioral Rating Inventory of Executive Functioning (BRIEF). Conclusion. This randomized control trial provides preliminary evidence of the effectiveness of computer-based interventions for ADHD and supports the feasibility of offering them in a school setting.

Preliminary results of tracked photorefractive keratectomy (T-PRK) for mild to moderate myopia with the autonomous technologies excimer laser at Cedars-Sinai Medical Center

NASA Astrophysics Data System (ADS)

Maguen, Ezra I.; Salz, James J.; Nesburn, Anthony B.

1997-05-01

Preliminary results of the correction of myopia up to -7.00 D by tracked photorefractive keratectomy (T-PRK) with a scanning and tracking excimer laser by Autonomous Technologies are discussed. 41 eyes participated (20 males). 28 eyes were evaluated one month postop. At epithelization day mean uncorrected vision was 20/45.3. At one month postop, 92.8 of eyes were 20/40 and 46.4% were 20/20. No eye was worse than 20/50. 75% of eyes were within +/- 0.5 D of emmetropia and 82% were within +/- 1.00 D of emmetropia. Eyes corrected for monovision were included. One eye lost 3 lines of best corrected vision, and had more than 1.00 D induced astigmatism due to a central corneal ulcer. Additional complications included symptomatic recurrent corneal erosions which were controlled with topical hypertonic saline. T-PRK appears to allow effective correction of low to moderate myopia. Further study will establish safety and efficacy of the procedure.

A Preliminary RCT of CBT-AD for Adherence and Depression among HIV-Positive Latinos on the U.S. –Mexico Border: The Nuevo Día Study

PubMed Central

Simoni, Jane M.; Wiebe, John S.; Sauceda, John A.; Huh, David; Sanchez, Giselle; Longoria, Virginia; Bedoya, C. Andres; Safren, Steven A.

2013-01-01

We conducted a preliminary RCT among 40 HIV-positive Latinos of Mexican descent on the U.S.-Mexico border who indicated imperfect adherence and depressive symptomatology. Participants were randomly assigned to culturally adapted cognitive-behavioral therapy for adherence and depression (CBT-AD) with an alarmed pillbox or usual care. Outcomes were depressive symptoms (self-report and blind clinician ratings), adherence (self-report and electronic pillbox), and biological markers. The intervention, delivered in English and Spanish, proved feasible and acceptable. Generalized estimating equations in intent-to-treat analyses showed some effects of “moderate” to “large” size, with maintenance over time. For example, intervention (vs. control) participants demonstrated at post-intervention a greater drop in BDI scores (OR = - 3.64, p = .05) and greater adherence according to the electronic pillbox (OR = 3.78, p = .03). Biological markers indicated some relative improvement for CD4 count but not VL. The promising results suggest a larger trial to determine efficacy is warranted. PMID:23812892

Δ9-THC Intoxication by Cannabidiol-Enriched Cannabis Extract in Two Children with Refractory Epilepsy: Full Remission after Switching to Purified Cannabidiol.

PubMed

Crippa, José A S; Crippa, Ana C S; Hallak, Jaime E C; Martín-Santos, Rocio; Zuardi, Antonio W

2016-01-01

Animal studies and preliminary clinical trials have shown that cannabidiol (CBD)-enriched extracts may have beneficial effects for children with treatment-resistant epilepsy. However, these compounds are not yet registered as medicines by regulatory agencies. We describe the cases of two children with treatment-resistant epilepsy (Case A with left frontal dysplasia and Case B with Dravet Syndrome) with initial symptom improvement after the introduction of CBD extracts followed by seizure worsening after a short time. The children presented typical signs of intoxication by Δ9-THC (inappropriate laughter, ataxia, reduced attention, and eye redness) after using a CBD-enriched extract. The extract was replaced by the same dose of purified CBD with no Δ9-THC in both cases, which led to improvement in intoxication signs and seizure remission. These cases support pre-clinical and preliminary clinical evidence suggesting that CBD may be effective for some patients with epilepsy. Moreover, the cases highlight the need for randomized clinical trials using high-quality and reliable substances to ascertain the safety and efficacy of cannabinoids as medicines.

Assessment of hemodynamics of intracranial aneurysms using Doppler optical coherence tomography in patient specific phantoms: preliminary results (Conference Presentation)

NASA Astrophysics Data System (ADS)

Ramjist, Joel M.; Jivraj, Jamil; Barrows, Dexter; Vuong, Barry; Wong, Ronnie; Yang, Victor X. D.

2017-02-01

Intracranial aneurysms affect a large number of individuals every year. Changes to hemodynamics are thought to be a crucial factor in the initial formation and enlargement of intracranial aneurysms. Previously, surgical clipping - an open an invasive procedure, was the standard of care. More recently, minimally invasive, catheter based therapies, specifically stenting and coiling, has been employed for treatment as it is less invasive and poses fewer overall risks. However, these treatments can further alter hemodynamic patterns of patients, affecting efficacy and prognosis. Doppler optical coherence tomography (DOCT) has shown to be useful for the evaluation of changes to hemodynamic patterns in various vascular pathologies, and intravascular DOCT may provide useful insight in the evaluation and changes to hemodynamic patterns before and during the treatment of aneurysms. In this study, we present preliminary results of DOCT imaging used in three patient-specific aneurysm phantoms located within the Circle of Willis both pre and post-treatment. These results are compared with computational fluid dynamics (CFD) simulations and high-speed camera imaging for further interpretation and validation of results.

Using Video Games to Enhance Motivation States in Online Education: Protocol for a Team-Based Digital Game.

PubMed

Janssen, Anna; Shaw, Tim; Goodyear, Peter

2015-09-28

Video and computer games for education have been of interest to researchers for several decades. Over the last half decade, researchers in the health sector have also begun exploring the value of this medium. However, there are still many gaps in the literature regarding the effective use of video and computer games in medical education, particularly in relation to how learners interact with the platform, and how the games can be used to enhance collaboration. The objective of the study is to evaluate a team-based digital game as an educational tool for engaging learners and supporting knowledge consolidation in postgraduate medical education. A mixed methodology will be used in order to establish efficacy and level of motivation provided by a team-based digital game. Second-year medical students will be recruited as participants to complete 3 matches of the game at spaced intervals, in 2 evenly distributed teams. Prior to playing the game, participants will complete an Internet survey to establish baseline data. After playing the game, participants will voluntarily complete a semistructured interview to establish motivation and player engagement. Additionally, metrics collected from the game platform will be analyzed to determine efficacy. The research is in the preliminary stages, but thus far a total of 54 participants have been recruited into the study. Additionally, a content development group has been convened to develop appropriate content for the platform. Video and computer games have been demonstrated to have value for educational purposes. Significantly less research has addressed how the medium can be effectively utilized in the health sector. Preliminary data from this study would suggest there is an interest in games for learning in the medical student body. As such, it is beneficial to undertake further research into how these games teach and engage learners in order to evaluate their role in tertiary and postgraduate medical education in the future.

Using Video Games to Enhance Motivation States in Online Education: Protocol for a Team-Based Digital Game

PubMed Central

Shaw, Tim; Goodyear, Peter

2015-01-01

Background Video and computer games for education have been of interest to researchers for several decades. Over the last half decade, researchers in the health sector have also begun exploring the value of this medium. However, there are still many gaps in the literature regarding the effective use of video and computer games in medical education, particularly in relation to how learners interact with the platform, and how the games can be used to enhance collaboration. Objective The objective of the study is to evaluate a team-based digital game as an educational tool for engaging learners and supporting knowledge consolidation in postgraduate medical education. Methods A mixed methodology will be used in order to establish efficacy and level of motivation provided by a team-based digital game. Second-year medical students will be recruited as participants to complete 3 matches of the game at spaced intervals, in 2 evenly distributed teams. Prior to playing the game, participants will complete an Internet survey to establish baseline data. After playing the game, participants will voluntarily complete a semistructured interview to establish motivation and player engagement. Additionally, metrics collected from the game platform will be analyzed to determine efficacy. Results The research is in the preliminary stages, but thus far a total of 54 participants have been recruited into the study. Additionally, a content development group has been convened to develop appropriate content for the platform. Conclusions Video and computer games have been demonstrated to have value for educational purposes. Significantly less research has addressed how the medium can be effectively utilized in the health sector. Preliminary data from this study would suggest there is an interest in games for learning in the medical student body. As such, it is beneficial to undertake further research into how these games teach and engage learners in order to evaluate their role in tertiary and postgraduate medical education in the future. PMID:26416522

Prevalence of Circulating Tumor Cells After Adjuvant Chemotherapy With or Without Anthracyclines in Patients With HER2-negative, Hormone Receptor-positive Early Breast Cancer.

PubMed

Schramm, Amelie; Schochter, Fabienne; Friedl, Thomas W P; de Gregorio, Nikolaus; Andergassen, Ulrich; Alunni-Fabbroni, Marianna; Trapp, Elisabeth; Jaeger, Bernadette; Heinrich, Georg; Camara, Oumar; Decker, Thomas; Ober, Angelika; Mahner, Sven; Fehm, Tanja N; Pantel, Klaus; Fasching, Peter A; Schneeweiss, Andreas; Janni, Wolfgang; Rack, Brigitte K

2017-07-01

Use of anthracycline-based chemotherapy in patients with early breast cancer (EBC) has been well-established but is often associated with cardiotoxicity. Based on data suggesting a limited benefit of anthracyclines in human epidermal growth factor receptor 2 (HER2)-negative patients, the Simultaneous Study of Docetaxel Based Anthracycline Free Adjuvant Treatment Evaluation, as well as Life Style Intervention Strategies (SUCCESS) C study randomized patients to either anthracycline-containing or anthracycline-free chemotherapy. Given the proven prognostic value of circulating tumor cells (CTCs) in EBC, we compared the prevalence of CTCs after chemotherapy between both treatment arms for a preliminary efficacy assessment. The SUCCESS C trial (NCT00847444) is an open-label, phase III study randomizing 3547 patients with HER2-negative EBC to either 3 cycles of epirubicin, 5-fluorouracil, and cyclophosphamide followed by 3 cycles of docetaxel (FEC-DOC) or 6 cycles of docetaxel and cyclophosphamide (DOC-C). CTC status was prospectively evaluated in hormone receptor-positive patients at the time of last chemotherapy cycle using the US Food and Drug Administration-approved CellSearch System (Janssen Diagnostics). Data on CTC status were available for 1766 patients. Overall, CTCs were found in 221 (12.5%) patients. Univariate analyses revealed that presence of CTCs at time of last chemotherapy cycle was not significantly associated with tumor or patient characteristics (all P > .1). There was no significant difference with respect to presence of CTCs between patients randomized to FEC-DOC or DOC-C (11.5% vs. 13.6%; P = .18). The comparable prevalence of CTCs at the time of last chemotherapy cycle may indicate that anthracycline-free chemotherapy is equally effective to anthracycline-containing chemotherapy in HER2-negative, hormone receptor-positive EBC. However, efficacy data from the final survival analysis of SUCCESS C have to be awaited to confirm these preliminary findings. Copyright © 2017 Elsevier Inc. All rights reserved.

A pilot study of cranial electrotherapy stimulation for generalized anxiety disorder.

PubMed

Bystritsky, Alexander; Kerwin, Lauren; Feusner, Jamie

2008-03-01

Cranial electrotherapy stimulation (CES) is a noninvasive procedure that has been used for decades in the United States to treat anxiety, depression, and insomnia in the general population. Whether CES is an effective treatment for patients with a DSM-IV diagnosis of generalized anxiety disorder (GAD) has not previously been explored. The goal of this study was to evaluate the efficacy of CES in alleviating anxiety in patients with DSM-IV-diagnosed GAD. Twelve patients from 29 to 58 years of age with a DSM-IV diagnosis of GAD were enrolled from August 2005 to March 2006 through the University of California, Los Angeles (UCLA) Anxiety Disorders Program. Cranial electrotherapy stimulation treatment was administered for 6 weeks using the Alpha-Stim Stress Control System at 0.5-Hz frequency and 300-muA intensity. The primary efficacy measures were the Hamilton Rating Scale for Anxiety (HAM-A) and the Clinical Global Impressions-Improvement (CGI-I) scale. Response to treatment was defined as a reduction of 50% or more on the HAM-A and a CGI-I score of 1 or 2 ("much improved" or "very much improved," respectively). Cranial electrotherapy stimulation was associated with a significant decrease in HAM-A scores (t = 3.083, p = .01). At endpoint, 6 patients (50% of the intent-to-treat sample and 67% of completers) had a 50% decrease in HAM-A score and a CGI-I score of 1 or 2. One additional patient significantly improved in anxiety scores but did not meet criteria for response. Adverse events were generally mild in severity, mostly consisting of headache and nausea. This preliminary study suggests that CES may reduce symptoms of anxiety in GAD. We hope that these preliminary results will encourage further research to explore the use of CES in clinical settings. clinicaltrials.gov Identifier: NCT00539357.

Phase I Study of Inotuzumab Ozogamicin Combined with R-CVP for Relapsed/Refractory CD22+ B-cell Non-Hodgkin Lymphoma.

PubMed

Ogura, Michinori; Tobinai, Kensei; Hatake, Kiyohiko; Davies, Andrew; Crump, Michael; Ananthakrishnan, Revathi; Ishibashi, Taro; Paccagnella, M Luisa; Boni, Joseph; Vandendries, Erik; MacDonald, David

2016-10-01

To evaluate the safety, preliminary efficacy, and pharmacokinetics of inotuzumab ozogamicin, an anti-CD22 antibody conjugated to calicheamicin, in combination with the immunochemotherapeutic regimen, rituximab, cyclophosphamide, vincristine, and prednisone (R-CVP), in patients with relapsed/refractory CD22+ B-cell non-Hodgkin lymphoma (NHL). In part 1 (n = 16), patients received inotuzumab ozogamicin plus R-CVP on a 21-day cycle with escalating doses of cyclophosphamide first then inotuzumab ozogamicin. Part 2 (n = 10) confirmed the safety and tolerability of the maximum tolerated dose (MTD), which required a dose-limiting toxicity rate of <33% in cycle 1 and <33% of patients discontinuing before cycle 3 due to treatment-related adverse events (AEs). Part 3 (n = 22) evaluated the preliminary efficacy of inotuzumab ozogamicin plus R-CVP. The MTD was determined to be standard-dose R-CVP plus inotuzumab ozogamicin 0.8 mg/m 2 The most common treatment-related grade ≥3 AEs in the MTD cohort (n = 38) were hematologic: neutropenia (74%), thrombocytopenia (50%), lymphopenia (42%), and leukopenia (47%). Among the 48 patients treated in the study, 13 discontinued due to AEs, most commonly thrombocytopenia (n = 10). Overall, 13 patients died, including one death due to treatment-related pneumonia secondary to neutropenia. Among patients receiving the MTD (n = 38), the overall response rate (ORR) was 84% (n = 32), including 24% (n = 9) with complete response; the ORR was 100% for patients with indolent lymphoma (n = 27) and 57% for those with aggressive histology lymphoma (n = 21). Inotuzumab ozogamicin at 0.8 mg/m 2 plus full dose R-CVP was associated with manageable toxicities and demonstrated a high rate of response in patients with relapsed/refractory CD22+ B-cell NHL. The study is registered at ClinicalTrials.gov (NCT01055496). Clin Cancer Res; 22(19); 4807-16. ©2016 AACR. ©2016 American Association for Cancer Research.

Antidepressive, anxiolytic, and antiaddictive effects of ayahuasca, psilocybin and lysergic acid diethylamide (LSD): a systematic review of clinical trials published in the last 25 years.

PubMed

Dos Santos, Rafael G; Osório, Flávia L; Crippa, José Alexandre S; Riba, Jordi; Zuardi, Antônio W; Hallak, Jaime E C

2016-06-01

To date, pharmacological treatments for mood and anxiety disorders and for drug dependence show limited efficacy, leaving a large number of patients suffering severe and persistent symptoms. Preliminary studies in animals and humans suggest that ayahuasca, psilocybin and lysergic acid diethylamide (LSD) may have antidepressive, anxiolytic, and antiaddictive properties. Thus, we conducted a systematic review of clinical trials published from 1990 until 2015, assessing these therapeutic properties. Electronic searches were performed using the PubMed, LILACS, and SciELO databases. Only clinical trials published in peer-reviewed journals were included. Of these, 151 studies were identified, of which six met the established criteria. Reviewed studies suggest beneficial effects for treatment-resistant depression, anxiety and depression associated with life-threatening diseases, and tobacco and alcohol dependence. All drugs were well tolerated. In conclusion, ayahuasca, psilocybin and LSD may be useful pharmacological tools for the treatment of drug dependence, and anxiety and mood disorders, especially in treatment-resistant patients. These drugs may also be useful pharmacological tools to understand psychiatric disorders and to develop new therapeutic agents. However, all studies reviewed had small sample sizes, and half of them were open-label, proof-of-concept studies. Randomized, double-blind, placebo-controlled studies with more patients are needed to replicate these preliminary findings.

Antidepressive, anxiolytic, and antiaddictive effects of ayahuasca, psilocybin and lysergic acid diethylamide (LSD): a systematic review of clinical trials published in the last 25 years

PubMed Central

dos Santos, Rafael G.; Osório, Flávia L.; Crippa, José Alexandre S.; Riba, Jordi; Zuardi, Antônio W.; Hallak, Jaime E. C.

2016-01-01

To date, pharmacological treatments for mood and anxiety disorders and for drug dependence show limited efficacy, leaving a large number of patients suffering severe and persistent symptoms. Preliminary studies in animals and humans suggest that ayahuasca, psilocybin and lysergic acid diethylamide (LSD) may have antidepressive, anxiolytic, and antiaddictive properties. Thus, we conducted a systematic review of clinical trials published from 1990 until 2015, assessing these therapeutic properties. Electronic searches were performed using the PubMed, LILACS, and SciELO databases. Only clinical trials published in peer-reviewed journals were included. Of these, 151 studies were identified, of which six met the established criteria. Reviewed studies suggest beneficial effects for treatment-resistant depression, anxiety and depression associated with life-threatening diseases, and tobacco and alcohol dependence. All drugs were well tolerated. In conclusion, ayahuasca, psilocybin and LSD may be useful pharmacological tools for the treatment of drug dependence, and anxiety and mood disorders, especially in treatment-resistant patients. These drugs may also be useful pharmacological tools to understand psychiatric disorders and to develop new therapeutic agents. However, all studies reviewed had small sample sizes, and half of them were open-label, proof-of-concept studies. Randomized, double-blind, placebo-controlled studies with more patients are needed to replicate these preliminary findings. PMID:27354908

Gerontological Competencies among MSW Students: Evaluation of a Gerontology Specialization Program.

PubMed

Wilks, Scott E; Cain, Daphne S; Reed-Ashcraft, Kellie B; Geiger, Jen

2017-01-01

The purpose of this study was to conduct a preliminary evaluation of a gerontology specialization program (GSP) within a Council on Social Work Education (CSWE)-accredited master of social work (MSW) program. This study utilized a pretest/posttest design with a three-group comparison: group 1-GSP students; group 2-students from the group 1 program but not in GSP; and group 3-students at two external MSW programs with no GSPs. The overall sample comprised 220 advanced year students. A CSWE Gero-Ed Center/Hartford Partnership empirical measure was used to assess overall, gero social work practice competency. Within-group analyses revealed a significant increase in gero competency scores from pretest to posttest among all groups, with GSP students showing the largest increase. Between-group analysis at pretest revealed that the GSP group showed lower gero competency scores than both non-GSP groups. At posttest, these results overturned: GSP students scored significantly higher gero competency scores than both non-GSP groups. These preliminary findings suggest that the GSP offers an impactful, positive role in development of practice skills for the next generation of gero social work practitioners and scholars. A follow-up study with additional years of data will increase longitudinal rigor and confidence in the long-range efficacy of this GSP.

Acetyl-L-Carnitine Augmentation of Clozapine in Partial-Responder Schizophrenia: A 12-Week, Open-Label Uncontrolled Preliminary Study.

PubMed

Bruno, Antonio; Pandolfo, Gianluca; Crucitti, Manuela; Lorusso, Simona; Zoccali, Rocco Antonio; Muscatello, Maria Rosaria Anna

This was the first 12-week, open-label, uncontrolled trial aimed at exploring the efficacy of acetyl-L-carnitine (ALC) add-on pharmacotherapy on clinical symptoms and cognitive functioning in 15 schizophrenia patients with suboptimal clinical response despite receiving clozapine (CLZ) monotherapy at the highest tolerated dosage. After clinical (Positive and Negative Symptoms Scale [PANSS]) and neuropsychological (Wisconsin Card Sorting Test, Stroop Color-Word Test, Verbal Fluency Test) assessments, patients received 1 g/d of ALC for 12 weeks. A final sample of 9 subjects completed the study. Acetyl-L-carnitine augmentation of CLZ significantly reduced only PANSS domains "positive" (P = 0.049); at end point, only 2 subjects (22.2% of the completers) reached a minimal improvement (25% reduction in PANSS total score). No significant differences emerged in cognitive performances at the end of the study; effect sizes were small in each explored cognitive dimension. The findings provide preliminary evidence that ALC added to ongoing CLZ treatment appeared to be ineffective to improve symptoms in schizophrenia patients who have failed to respond sufficiently to CLZ. Further trials with adequately powered methodology are needed to identify which augmentation strategies are more effective in schizophrenia patients showing a suboptimal response to CLZ.

Virtual reality therapy versus cognitive behavior therapy for social phobia: a preliminary controlled study.

PubMed

Klinger, E; Bouchard, S; Légeron, P; Roy, S; Lauer, F; Chemin, I; Nugues, P

2005-02-01

Social phobia is one of the most frequent mental disorders and is accessible to two forms of scientifically validated treatments: anti-depressant drugs and cognitive behavior therapies (CBT). In this last case, graded exposure to feared social situations is one of the fundamental therapeutic ingredients. Virtual reality technologies are an interesting alternative to the standard exposure in social phobia, especially since studies have shown its usefulness for the fear of public speaking. This paper reports a preliminary study in which a virtual reality therapy (VRT), based on exposure to virtual environments, was used to treat social phobia. The sample consisted of 36 participants diagnosed with social phobia assigned to either VRT or a group-CBT (control condition). The virtual environments used in the treatment recreate four situations dealing with social anxiety: performance, intimacy, scrutiny, and assertiveness. With the help of the therapist, the patient learns adapted cognitions and behaviors in order to reduce anxiety in the corresponding real situations. Both treatments lasted 12 weeks, and sessions were delivered according to a treatment manual. Results showed statistically and clinically significant improvement in both conditions. The effect-sizes comparing the efficacy of VRT to the control traditional group-CBT revealed that the differences between the two treatments are trivial.

Preliminary study on carprofen concentration measurements after transcutaneous treatment with Vetdrop® in a microfracture joint defect model in sheep.

PubMed

Sidler, Michèle; Fouché, Nathalie; Meth, Ingmar; von Hahn, Friedrich; von Rechenberg, Brigitte; Kronen, Peter W

2014-12-09

The present preliminary study describes concentration time courses of the NSAID carprofen in the plasma and synovial fluid in a microfrature sheep model after transcutaneous treatments with a novel application device (Vetdrop®). To treat circumscribed inflammatory processes a transcutaneous application device could potentially be beneficial. After transcutaneous application normally lower systemic concentrations are measured which may reduce the incidence of side effects, whereas efficacy is still maintained. In this study carprofen was used based on its capacity to provide analgesia after orthopaedic procedures in sheep and it is considered that it may have a positive influence on the healing of cartilage in low concentrations. In all transcutaneously treated animals, carprofen plasma concentrations exceeded those of synovial fluid, although plasma levels remained significantly reduced (300-fold) as compared to carprofen administered intravenously. Furthermore, in contrast to the intravenously treated animals, a modest accumulation of carprofen in plasma and synovial fluid was observed in the transcutaneously treated animals over the 6-week treatment period. The transcutaneously administered carprofen using the Vetdrop® device penetrated the skin and both, plasma- and synovial concentrations could be measured repeatedly over time. This novel device may be considered a valuable transcutaneous drug delivery system.

Virtual reality bringing a new reality to postthoracotomy lung cancer patients via a home-based exercise intervention targeting fatigue while undergoing adjuvant treatment.

PubMed

Hoffman, Amy J; Brintnall, Ruth Ann; Brown, Jean K; von Eye, Alexander; Jones, Lee W; Alderink, Gordon; Ritz-Holland, Deborah; Enter, Mark; Patzelt, Lawrence H; VanOtteren, Glenn M

2014-01-01

Little is known about rehabilitation for postthoracotomy non-small cell lung cancer (NSCLC) patients. This research uses a perceived self-efficacy-enhancing light-intensity exercise intervention targeting a priority symptom, cancer-related fatigue (CRF), for postthoracotomy NSCLC patients. This article reports on phase II of a 2-phase study. Phase I focused on initiation and tolerance of exercise during the 6 weeks immediately after thoracotomy, whereas phase II addressed maintenance of exercise for an additional 10 weeks including participants initiating and completing chemotherapy and/or radiation therapy. The objective of this study was to investigate the feasibility, acceptability, and preliminary efficacy of an exercise intervention for postthoracotomy NSCLC patients to include those initiating and completing adjuvant therapy. A single-arm design composed of 7 participants postthoracotomy for NSCLC performed light-intensity exercises using an efficacy-enhancing virtual-reality approach using the Nintendo Wii Fit Plus. Despite most participants undergoing chemotherapy and/or radiation therapy, participants adhered to the intervention at a rate of 88% with no adverse events while giving the intervention high acceptability scores on conclusion. Likewise, participants' CRF scores improved from initiation through the conclusion of the intervention with perceived self-efficacy for walking at a light intensity continuously for 60 minutes, improving significantly upon conclusion over presurgery values. Postthoracotomy NSCLC patients maintained exercise for an additional 10 weeks while undergoing adjuvant therapy showing rehabilitation potential because the exercise intervention was feasible, safe, well tolerated, and highly acceptable showing positive changes in CRF self-management. A randomized controlled trial is needed to further investigate these relationships.

Mechanisms of action of brief alcohol interventions remain largely unknown - a narrative review.

PubMed

Gaume, Jacques; McCambridge, Jim; Bertholet, Nicolas; Daeppen, Jean-Bernard

2014-01-01

A growing body of evidence has shown the efficacy of brief intervention (BI) for hazardous and harmful alcohol use in primary health care settings. Evidence for efficacy in other settings and effectiveness when implemented at larger scale are disappointing. Indeed, BI comprises varying content; exploring BI content and mechanisms of action may be a promising way to enhance efficacy and effectiveness. Medline and PsychInfo, as well as references of retrieved publications were searched for original research or review on active ingredients (components or mechanisms) of face-to-face BIs [and its subtypes, including brief advice and brief motivational interviewing (BMI)] for alcohol. Overall, BI active ingredients have been scarcely investigated, almost only within BMI, and mostly among patients in the emergency room, young adults, and US college students. This body of research has shown that personalized feedback may be an effective component; specific MI techniques showed mixed findings; decisional balance findings tended to suggest a potential detrimental effect; while change plan exercises, advice to reduce or stop drinking, presenting alternative change options, and moderation strategies are promising but need further study. Client change talk is a potential mediator of BMI effects; change in norm perceptions and enhanced discrepancy between current behavior and broader life goals and values have received preliminary support; readiness to change was only partially supported as a mediator; while enhanced awareness of drinking, perceived risks/benefits of alcohol use, alcohol treatment seeking, and self-efficacy were seldom studied and have as yet found no significant support as such. Research is obviously limited and has provided no clear and consistent evidence on the mechanisms of alcohol BI. How BI achieves the effects seen in randomized trials remains mostly unknown and should be investigated to inform the development of more effective interventions.

Expert patient self-management program versus usual care in bronchiectasis: a randomized controlled trial.

PubMed

Lavery, Katherine A; O'Neill, Brenda; Parker, Michael; Elborn, J Stuart; Bradley, Judy M

2011-08-01

To investigate the efficacy of a disease-specific Expert Patient Programme (EPP) compared with usual care in patients with bronchiectasis. Proof-of-concept randomized controlled trial. Regional respiratory center. Adult patients (N=64; age, >18y) with a primary diagnosis of bronchiectasis based on a respiratory physician's assessment including a computed tomographic scan. Patients were randomly assigned to an intervention (usual care plus EPP; n=32) or control group (usual care only; n=32). The primary outcome measure was the Chronic Disease Self-efficacy Scale (CDSS). Other outcome measures included the Revised Illness Perception Questionnaire (IPQ-R), the St Georges Respiratory Questionnaire, and standard EPP questionnaires. Data were collected at baseline, postintervention, and 3 and 6 months postintervention. This disease-specific EPP for patients with bronchiectasis significantly improved self-efficacy in 6 of 10 subscales (CDSS subscales: exercise regularly [P=.02]; get information about disease [P=.03]; obtain help from community, family, and friends [P=.06]; communicate with physician [P=.85]; manage disease in general [P=.05]; do chores [P=.04]; social/recreational activities [P=.03]; manage symptoms [P<.01]; manage shortness of breath [P=.08]; control/manage depression [P=.01]) compared with usual care. There was no improvement on IPQ-R score. Patients who received the intervention reported more symptoms and decreased quality of life between 3 and 6 months postintervention and an increase in some components of self reported health care use. Patients receiving the disease-specific EPP indicated they were satisfied with the intervention and learned new self-management techniques. There were no significant differences in lung function over time. This original study indicates that a disease-specific EPP results in short-term improvements in self-efficacy. Based on these positive preliminary findings, a larger adequately powered study is justified to investigate the efficacy of a disease-specific EPP in patients with bronchiectasis. Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Lateral hypothalamic area deep brain stimulation for refractory obesity: a pilot study with preliminary data on safety, body weight, and energy metabolism

PubMed Central

Whiting, Donald M.; Tomycz, Nestor D.; Bailes, Julian; De Jonge, Lilian; Lecoultre, Virgile; Wilent, Bryan; Alcindor, Dunbar; Prostko, E. Richard; Cheng, Boyle C.; Angle, Cynthia; Cantella, Diane; Whiting, Benjamin B.; Mizes, J. Scott; Finnis, Kirk W.; Ravussin, Eric; Oh, Michael Y.

2017-01-01

Object Deep brain stimulation (DBS) of the lateral hypothalamic area (LHA) has been suggested as a potential treatment for intractable obesity. The authors present the 2-year safety results as well as early efficacy and metabolic effects in 3 patients undergoing bilateral LHA DBS in the first study of this approach in humans. Methods Three patients meeting strict criteria for intractable obesity, including failed bariatric surgery, under-went bilateral implantation of LHA DBS electrodes as part of an institutional review board– and FDA-approved pilot study. The primary focus of the study was safety; however, the authors also received approval to collect data on early efficacy including weight change and energy metabolism. Results No serious adverse effects, including detrimental psychological consequences, were observed with continuous LHA DBS after a mean follow-up of 35 months (range 30–39 months). Three-dimensional nonlinear transformation of postoperative imaging superimposed onto brain atlas anatomy was used to confirm and study DBS contact proximity to the LHA. No significant weight loss trends were seen when DBS was programmed using standard settings derived from movement disorder DBS surgery. However, promising weight loss trends have been observed when monopolar DBS stimulation has been applied via specific contacts found to increase the resting metabolic rate measured in a respiratory chamber. Conclusions Deep brain stimulation of the LHA may be applied safely to humans with intractable obesity. Early evidence for some weight loss under metabolically optimized settings provides the first “proof of principle” for this novel antiobesity strategy. A larger follow-up study focused on efficacy along with a more rigorous metabolic analysis is planned to further explore the benefits and therapeutic mechanism behind this investigational therapy. PMID:23560573

Crisaborole Topical Ointment, 2% in Adults With Atopic Dermatitis: A Phase 2a, Vehicle-Controlled, Proof-of-Concept Study.

PubMed

Murrell, Dedee F; Gebauer, Kurt; Spelman, Lynda; Zane, Lee T

2015-10-01

A novel approach for treating atopic dermatitis (AD) is the inhibition of phosphodiesterase 4 (PDE4), an enzyme involved in the proinflammatory cascade. Crisaborole topical ointment, 2% is a novel, boron-based small-molecule PDE4 inhibitor with anti-inflammatory properties. The objective of this proof-of-concept study was to assess the efficacy and safety of crisaborole topical ointment, 2% in adults with mild to moderate AD. This phase 2a, randomized, double-blind, bilateral, 6-week study of crisaborole topical ointment, 2% was conducted in adult patients with mild to moderate AD with 2 comparable target AD lesions. Patients were randomly assigned to twice-daily application of crisaborole topical ointment, 2% or vehicle, each to 1 of the 2 target lesions. The primary efficacy endpoint was change from baseline in Atopic Dermatitis Severity Index (ADSI) score at day 28. Safety assessments included local tolerability and incidence of adverse events (AEs). A total of 25 enrolled patients received study medication. At day 28, 17 patients (68%) experienced a greater decrease in ADSI score in the active-treated lesion than in the vehicle-treated lesion; 5 patients (20%) had a greater decrease in ADSI score in the vehicle-treated lesion than in the active-treated lesion. Local application-site reactions were reported in 3 patients (12%). A total of 29 AEs were reported in 11 patients; most (90%) were mild in intensity and unrelated to study medication. No serious or severe AEs were reported, and no patient discontinued due to an AE. These findings provide preliminary evidence of the efficacy and safety of treatment with crisaborole topical ointment, 2% in adults with mild to moderate AD. The study is registered on ClinicalTrials.gov (identifier NCT01301508).

Yoga in school settings: a research review.

PubMed

Khalsa, Sat Bir S; Butzer, Bethany

2016-06-01

Research on the efficacy of yoga for improving mental, emotional, physical, and behavioral health characteristics in school settings is a recent but growing field of inquiry. This systematic review of research on school-based yoga interventions published in peer-reviewed journals offers a bibliometric analysis that identified 47 publications. The studies from these publications have been conducted primarily in the United States (n = 30) and India (n = 15) since 2005, with the majority of studies (n = 41) conducted from 2010 onward. About half of the publications were of studies at elementary schools; most (85%) were conducted within the school curriculum, and most (62%) also implemented a formal school-based yoga program. There was a high degree of variability in yoga intervention characteristics, including overall duration, and the number and duration of sessions. Most of these published research trials are preliminary in nature, with numerous study design limitations, including limited sample sizes (median = 74; range = 20-660) and relatively weak research designs (57% randomized controlled trials, 19% uncontrolled trials), as would be expected in an infant research field. Nevertheless, these publications suggest that yoga in the school setting is a viable and potentially efficacious strategy for improving child and adolescent health and therefore worthy of continued research. © 2016 New York Academy of Sciences.

AFRRI Reports Second Quarter, April-June 1991

DTIC Science & Technology

1991-07-01

chosen after bacteria generally involves the use of aminoglycosides in preliminary data showed that the animals became suscepti- combination with beta ...antibiotic therapy in the febrile neutropenic cancer patient: ity of the mucosal cells damaged by irradiation, and (iii) the clinical efficacy and...mon- sidered to be inexorable signs of aging and may keb (1,9,28) and babuons (29). Simildrly, the rod- predispose to cancer of the stomach. Early in

Multi-fractal detrended texture feature for brain tumor classification

NASA Astrophysics Data System (ADS)

Reza, Syed M. S.; Mays, Randall; Iftekharuddin, Khan M.

2015-03-01

We propose a novel non-invasive brain tumor type classification using Multi-fractal Detrended Fluctuation Analysis (MFDFA) [1] in structural magnetic resonance (MR) images. This preliminary work investigates the efficacy of the MFDFA features along with our novel texture feature known as multifractional Brownian motion (mBm) [2] in classifying (grading) brain tumors as High Grade (HG) and Low Grade (LG). Based on prior performance, Random Forest (RF) [3] is employed for tumor grading using two different datasets such as BRATS-2013 [4] and BRATS-2014 [5]. Quantitative scores such as precision, recall, accuracy are obtained using the confusion matrix. On an average 90% precision and 85% recall from the inter-dataset cross-validation confirm the efficacy of the proposed method.

Mindfulness Therapy for Maladaptive Interpersonal Dependency: A Preliminary Randomized Controlled Trial.

PubMed

McClintock, Andrew S; Anderson, Timothy; Cranston, Saryn

2015-11-01

Existing treatments for maladaptive interpersonal dependency and dependent personality disorder do not meet basic scientific standards for effectiveness. The present investigation tested the efficacy of a mindfulness-based approach: mindfulness therapy for maladaptive interpersonal dependency (MT-MID). Forty-eight participants who reported consistently high levels of maladaptive dependency (i.e., scored higher than 1 standard deviation above the mean on the Interpersonal Dependency Inventory at two separate assessments) were randomized to either 5 sessions of MT-MID or a minimal contact control. Five self-reported outcomes (mindfulness, maladaptive interpersonal dependency, helplessness, fears of negative evaluation, and excessive reassurance seeking) were assessed at pretreatment, posttreatment, and a 4-week follow-up. Intent-to-treat analyses indicated that MT-MID yielded greater improvements than the control on all 5 outcomes at posttreatment (median d=1.61) and follow-up (median d=1.51). Participants assigned to MT-MID were more likely than control participants to meet criteria for clinically significant change at posttreatment (56.5% vs. 0%) and follow-up (42.9% vs. 0%). There was also evidence that increases in mindfulness mediated the dependency-related improvements. These results provide preliminary support for the efficacy of a mindfulness-based approach for treating the symptoms of maladaptive dependency. Copyright © 2015. Published by Elsevier Ltd.

Relationship among knowledge acquisition, motivation to change, and self-efficacy in CME participants.

PubMed

Williams, Betsy W; Kessler, Harold A; Williams, Michael V

2015-01-01

The relationship among an individual's sense of self-efficacy, motivation to change, barriers to change, and the implementation of improvement programs has been reported. This research reports the relationship among self-efficacy, motivation to change, and the acquisition of knowledge in a continuing medical education (CME) activity. The measure of individual sense of self-efficacy was a 4-item scale. The measure of motivation was a 6-item scale following on the work of Prochaska and colleagues. The knowledge acquisition was measured in a simple post measure. The participants were enrolled in a CME activity focused on HIV.  The CME activities had a significant effect on knowledge. Preliminary analysis demonstrates a relationship among the self-efficacy measure, the motivation to change measure, and global intent to change. Specifically, as reported earlier, the sense of efficacy in effecting change in the practice environment is predictive of a high level of motivation to change that, in turn, is predictive of formation of intent to change practice patterns. Interestingly, there were also relationships among the self-efficacy measure, the motivation to change measure, and knowledge acquisition. Finally, as expected, there was a significant relationship between knowledge and intent to change practice.  Further inspection of the motivation to change construct suggests that it mediates the self-efficacy constructs' effect on intent as well as its effect on knowledge acquisition. This new finding suggests that the proximal construct motivation completely masks an important underlying causal relationship that appears to contribute to practice change as well as learning following CME-self-efficacy. © 2015 The Alliance for Continuing Education in the Health Professions, the Society for Academic Continuing Medical Education, and the Council on Continuing Medical Education, Association for Hospital Medical Education.

Efficacy of Eye Movement Desensitization and Reprocessing in Children and Adolescent with Post-traumatic Stress Disorder: A Meta-Analysis of Randomized Controlled Trials

PubMed Central

Moreno-Alcázar, Ana; Treen, Devi; Valiente-Gómez, Alicia; Sio-Eroles, Albert; Pérez, Víctor; Amann, Benedikt L.; Radua, Joaquim

2017-01-01

Background: Post-traumatic stress disorder (PTSD) can occur in both adults and children/adolescents. Untreated PTSD can lead to negative long-term mental health conditions such as depression, anxiety, low self-concept, disruptive behaviors, and/or substance use disorders. To prevent these adverse effects, treatment of PTSD is essential, especially in young population due to their greater vulnerability. The principal aim of this meta-analysis was to examine the efficacy of eye movement desensitization and reprocessing (EMDR) therapy for PTSD symptoms in children and adolescents. Secondary objectives were to assess whether EMDR therapy was effective to improve depressive or anxious comorbid symptoms. Methods: We conducted a thorough systematic search of studies published until January 2017, using PubMed, Medline, Scopus, and ScienceDirect as databases. All randomized controlled trials with an EMDR group condition compared to a control group, such as treatment as usual or another psychological treatment, were included. Meta-analysis was conducted with MetaNSUE to avoid biases related to missing information. Results: Eight studies (n = 295) met our inclusion criteria. EMDR therapy was superior to waitlist/placebo conditions and showed comparable efficacy to cognitive behavior therapy (CBT) in reducing post-traumatic and anxiety symptoms. A similar but non-statistically significant trend was observed for depressive symptoms. Exploratory subgroup analyses showed that effects might be smaller in studies that included more males and in more recent studies. Conclusion: Despite the small number of publications, the obtained results suggest that EMDR therapy could be a promising psychotherapeutic approach for the treatment of PTSD and comorbid symptoms in young individuals. However, further research with larger samples is needed to confirm these preliminary results as well as to analyze differences in the efficacy of EMDR therapy versus CBT. PMID:29066991

Everyday episodic memory in amnestic mild cognitive impairment: a preliminary investigation.

PubMed

Irish, Muireann; Lawlor, Brian A; Coen, Robert F; O'Mara, Shane M

2011-08-04

Decline in episodic memory is one of the hallmark features of Alzheimer's disease (AD) and is also a defining feature of amnestic Mild Cognitive Impairment (MCI), which is posited as a potential prodrome of AD. While deficits in episodic memory are well documented in MCI, the nature of this impairment remains relatively under-researched, particularly for those domains with direct relevance and meaning for the patient's daily life. In order to fully explore the impact of disruption to the episodic memory system on everyday memory in MCI, we examined participants' episodic memory capacity using a battery of experimental tasks with real-world relevance. We investigated episodic acquisition and delayed recall (story-memory), associative memory (face-name pairings), spatial memory (route learning and recall), and memory for everyday mundane events in 16 amnestic MCI and 18 control participants. Furthermore, we followed MCI participants longitudinally to gain preliminary evidence regarding the possible predictive efficacy of these real-world episodic memory tasks for subsequent conversion to AD. The most discriminating tests at baseline were measures of acquisition, delayed recall, and associative memory, followed by everyday memory, and spatial memory tasks, with MCI patients scoring significantly lower than controls. At follow-up (mean time elapsed: 22.4 months), 6 MCI cases had progressed to clinically probable AD. Exploratory logistic regression analyses revealed that delayed associative memory performance at baseline was a potential predictor of subsequent conversion to AD. As a preliminary study, our findings suggest that simple associative memory paradigms with real-world relevance represent an important line of enquiry in future longitudinal studies charting MCI progression over time.

Safety and efficacy of subcutaneous tanezumab in patients with knee or hip osteoarthritis.

PubMed

Birbara, Charles; Dabezies, Eugene J; Burr, Aimee M; Fountaine, Robert J; Smith, Michael D; Brown, Mark T; West, Christine R; Arends, Rosalin H; Verburg, Kenneth M

2018-01-01

The objective of this study was to investigate the safety and efficacy of subcutaneous (SC) and intravenous (IV) tanezumab administration in osteoarthritis (OA) patients. Study 1027 (NCT01089725), a placebo-controlled trial, evaluated the efficacy of SC tanezumab (ie, 2.5, 5, and 10 mg) and the therapeutic equivalence of 10 mg tanezumab given subcutaneously versus intravenously every 8 weeks in the symptomatic treatment of OA. Coprimary endpoints were: change from baseline in Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) Pain and Physical Function indices, and Patient's Global Assessment (PGA) of OA. Study 1043 (NCT00994890) was a long-term, noncontrolled safety study of tanezumab (ie, 2.5, 5, and 10 mg) subcutaneously administered every 8 weeks. Both studies were discontinued prematurely due to a US Food and Drug Administration partial clinical hold. Due to the clinical hold, Study 1027 was underpowered, and no statistical analyses were performed. Mean (standard error [SE]) change from baseline to week 8 in WOMAC Pain in tanezumab groups ranged from -3.59 (0.26) to -3.89 (0.32), versus -2.74 (0.25) with placebo. Mean (SE) change from baseline to week 8 in WOMAC Physical Function ranged from -3.13 (0.25) to -3.51 (0.28) with tanezumab and was -2.26 (0.24) with placebo. PGA mean (SE) change from baseline to week 8 ranged from -0.90 (0.11) to -1.08 (0.12) with tanezumab and was -0.78 (0.10) with placebo. Similar effectiveness was associated with tanezumab in Study 1043. Few patients in either study (1.4%-5.2%) discontinued due to adverse events. Five patients required total joint replacements in Study 1027 (placebo, n=2 [2.8%]; tanezumab 2.5 mg, n=3 [4.1%]) and 34 patients in Study 1043 (tanezumab 2.5 mg, n=11 [4.8%]; tanezumab 5 mg, n=8 [3.6%]; tanezumab 10 mg, n=15 [6.6%]). Preliminary results show similar efficacy and safety for both SC and IV administration of tanezumab based on the direct comparisons reported here and indirect comparisons with published results, confirming pharmacokinetic/pharmacodynamic modeling predictions.

Tai Ji Quan and global cognitive function in older adults with cognitive impairment: a pilot study.

PubMed

Li, Fuzhong; Harmer, Peter; Liu, Yu; Chou, Li-Shan

2014-01-01

This study evaluated whether Tai Ji Quan: Moving for Better Balance (TJQMBB) could improve global cognitive function in older adults with cognitive impairment. Using a nonrandomized control group pretest-posttest design, participants aged ≥65 years who scored between 20 and 25 on the Mini-Mental State Examination (MMSE) were allocated into either a 14-week TJQMBB program (n=22) or a control group (n=24). The primary outcome was MMSE as a measure of global cognitive function with secondary outcomes of 50-ft speed walk, Timed Up&Go, and Activities-Specific Balance Confidence (ABC) scale. At 14 weeks, Tai Ji Quan participants showed significant improvement on MMSE (mean=2.26, p<0.001) compared to controls (mean=0.63, p=0.08). Similarly, Tai Ji Quan participants performed significantly better compared to the controls in both physical performance and balance efficacy measures (p<0.05). Improvement in cognition as measured by MMSE was related to improved physical performance and balance efficacy. These results provide preliminary evidence of the utility of the TJQMBB program to promote cognitive function in older adults in addition to physical benefits. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Insulin in human milk and the use of hormones in infant formulas.

PubMed

Shamir, Raanan; Shehadeh, Naim

2013-01-01

Human milk contains a substantial number of hormones and growth factors. Studies in animal models show that some of these peptides (e.g. insulin, insulin-like growth factor 1, IGF-1, epidermal growth factors) have an effect on the small intestine after orogastric administration. Recently, two efforts were made to incorporate growth factors into infant formulas. One of these efforts included the incorporation of IGF-1, and the second is an ongoing effort to evaluate the safety and efficacy of incorporating insulin into infant formulas. The rational and current evidence for adding insulin to infant formulas (presence in human milk, effects of orally administrated insulin on gut maturation, intestinal permeability, systemic effects and preliminary encouraging results of supplementing insulin to a preterm infant formula) is detailed in this review. If the addition of insulin to preterm infant formulas indeed results in better growth and accelerated intestinal maturation, future studies will need to address the supplementation of insulin in term infants and assess the efficacy of such supplementation in enhancing gut maturation and prevention of later noncommunicable diseases such as allergy, autoimmune diseases and obesity. Copyright © 2013 Nestec Ltd., Vevey/S. Karger AG, Basel.

Safety and immunogenecity of a live attenuated Rift Valley fever vaccine (CL13T) in camels.

PubMed

Daouam, S; Ghzal, F; Naouli, Y; Tadlaoui, K O; Ennaji, M M; Oura, C; El Harrak, M

2016-07-26

Rift Valley fever is an emerging zoonotic viral disease, enzootic and endemic in Africa and the Arabian Peninsula, which poses a significant threat to both human and animal health. The disease is most severe in ruminants causing abortions in pregnant animals, especially sheep animals and high mortality in young populations. High mortality rates and severe clinical manifestation have also been reported among camel populations in Africa, to attend however none of the currently available live vaccines against RVF have been tested for safety and efficacy in this species. In this study, the safety and efficacy (through a neutralizing antibody response) of the thermostable live attenuated RVF CL13T vaccine were evaluated in camels in two different preliminary experiments involving 16 camels, (that 12 camels and 4 pregnant camels). The study revealed that the CL13T vaccine was safe to use in camels and no abortions or teratogenic effects were observed. The single dose of the vaccine stimulated a strong and long-lasting neutralizing antibody response for up to 12 months. The presence of neutralization antibodies is likely to correlate with protection; however protection would need to be confirmed by challenge experiments using the virulent RVF virus.

Preliminary results on clinical effects of probiotic Lactobacillus salivarius LS01 in children affected by atopic dermatitis.

PubMed

Niccoli, Antonio A; Artesi, Anna L; Candio, Francesco; Ceccarelli, Sara; Cozzali, Rita; Ferraro, Luigi; Fiumana, Donatella; Mencacci, Manuela; Morlupo, Maurizio; Pazzelli, Paola; Rossi, Laura; Toscano, Marco; Drago, Lorenzo

2014-01-01

The goal of this study was to evaluate the clinical efficacy of an intake of Lactobacillus salivarius LS01 (DSM 22775) for the treatment of atopic dermatitis (AD) in children. AD is an inflammatory and pruritic chronic relapsing skin disorder with multifactorial etiopathology. Some evidence suggests that probiotics may improve AD by modulating the immune system and the composition of intestinal microbiota. A total of 43 patients aged from 0 to 11 years were enrolled in the study (M/F ratio=1:1) and treated with the probiotic strain L. salivarius LS01. Clinical efficacy of probiotic treatment was assessed from baseline by changes in itch index and in the objective SCORAD/SCORAD index. Patients being given probiotic treatment showed a significant improvement in clinical parameters (SCORAD and itch values) from baseline. The reduction in SCORAD and itch index observed after 4 weeks of treatment also persisted after the cessation of probiotic supplementation. L. salivarius LS01 seems to be able to improve the quality of life of children affected by AD and, as a consequence, it may have promising clinical and research implications.

Pharmacological approaches to the treatment of complicated grief: rationale and a brief review of the literature

PubMed Central

Bui, Eric; Nadal-Vicens, Mireya; M. Simon, Naomi

2012-01-01

Complicated grief (CG) is a common and often under-acknowledged cause of profound impairment experienced after the loss of a loved one. Although both clinical and basic research suggests that pharmacological agents might be of use in the treatment of CG, research on pharmacological approaches to this condition is still scarce. Three open-label trials and one randomized trial on bereavement-related depression suggest that tricyclic antidepressants may be effective, although they may be more efficacious for depressive symptoms than for grief-specific symptoms. Four open-label trials (total number of participants, 50) of selective serotonin reuptake inhibitors (SSRIs) have yielded results, providing very preliminary support that they might be effective in the treatment of CG, both as a standalone treatment and in conjunction with psychotherapeutic interventions. These more recent studies have shown an effect on both depression and grief-specific scales. Furthermore, therapeutic interventions for CG may be more effective in conjunction with SSRI administration. Given the small number of pharmacological studies to date, there is a need for randomized trials to test the potential efficacy of pharmacological agents in the treatment of CG. PMID:22754287

Efficacy prediction of cevimeline in patients with Sjögren's syndrome.

PubMed

Yamada, Hiroyuki; Nakagawa, Yoichi; Wakamatsu, Ei; Sumida, Takayuki; Yamachika, Shigeo; Nomura, Yoshiaki; Mishima, Kenji; Saito, Ichiro

2007-08-01

The objective of this study was to examine the clinical and immunological factors influencing the efficacy of cevimeline hydrochloride hydrate (cevimeline) for the treatment of xerostomia in patients with Sjögren's syndrome (SS). Thirty primary SS patients who were medicated with cevimeline were enrolled in this study. Whole stimulated sialometry (WSS) was compared between pre- and posttreatment points (4 weeks after oral cevimeline administration) and the increment rate of WSS was calculated. Multiple regression was employed to examine the relative contributions of the clinical and immunological factors, including age, pretreatment WSS, duration of disease, sialography, minor salivary gland biopsy, anti-Ro/SS-A antibodies, anti-La/SS-B antibodies, and antibodies to muscarinic type 3 receptors to the posttreatment WSS. Patients with normal sialography findings, negative minor salivary gland biopsy, and absence of anti-La/SS-B antibodies had significantly higher increment rates of WSS compared with those with positive findings (p=0.042, 0.002, and 0.018, respectively). Results of the multiple regression analysis showed that sialography (coefficient=-0.867, p=0.004) and minor salivary gland biopsy (coefficient=-0.869, p=0.003) had significant associations with the posttreatment WSS. Our preliminary results demonstrated the relationship between the effect of cevimeline on saliva secretion and the degree of salivary gland destruction evaluated by sialography and histopathological findings in the labial minor salivary glands. These diagnostic approaches could provide useful prognostic information on the efficacy of cevimeline in SS patients.

A Brief Cognitive Behavioural Intervention for Maladaptive Perfectionism in Students: A Pilot Study.

PubMed

Arana, Fernán G; Miracco, Mariana C; Galarregui, Marina S; Keegan, Eduardo G

2017-09-01

Researchers focused on developing therapeutic strategies for perfectionism given its well-established link to the onset and maintenance of several mental disorders. Meta-analytical findings provided support for the efficacy of cognitive behavioural (CB) approaches. However, most studies have focused on the efficacy of interventions, without analysing their efficiency. To explore the feasibility of a brief (five weekly sessions) CB group intervention focused on reducing perfectionistic concerns in Argentine students. We also aimed to identify participants who benefited from the intervention and to explore their differences with non-respondents. A third aim was to explore the potential merits of the intervention in a different cultural context as this is the first attempt to adapt an English-spoken protocol to the Spanish language. A quasi-experimental design with two time points was used. Twenty-four out of 84 participants (mean age = 27.75 years, SD = 8.3) were classified as maladaptive perfectionists. Paired t-tests and reliable change index comparisons revealed that most students (75%) statistically and clinically reduced their levels of perfectionistic concerns as well as their perfectionistic strivings. General distress, operationalized as anxious and depressive symptoms, was also decreased. Students who completed and responded to the intervention were more dysfunctional in academic and psychological measures at baseline than non-completers and non-improvers. Findings support the feasibility, preliminary efficacy and efficiency of this five weekly session intervention when applied to a sample of Argentine university students.

[Spanish version of the Multidimensional health locus of control scale innursing students].

PubMed

Tomás-Sábado, Joaquín; Montes-Hidalgo, Javier

2016-01-01

To determine the preliminary psychometric properties of the Spanish form of the Multidimensional Health Locus of Control Scale (MHLC), which consists of three subscales: (1) Internalitu, (2) Powerful other externality, and (3) Chance externality. It also aims to study the relationship that the internal/external health control beliefs has with self-esteem, self-efficacy and perceived competence in a sample of nursing undergraduates. An observational and cross-sectional study including 109 nursing students who completed an anonymous questionnaire containing the demographic variables and the Spanish versions of the MHLC, the Rosenberg Self-Esteem Scale, the General Self-Efficacy Scale, and the Perceived personal competence Scale. A Cronbach's alpha coefficient of 0.713 for Internality, 0.665 for Chance and 0.728 for Powerful other were obtained. The test-retest correlation for the 18 items of the MHLC was 0.866. Internality subscale was positively and significantly correlated with self-efficacy and competence. By contrast, chance externality has negative and significant correlations with self-esteem and competence. There are no significant gender differences in any of the subscales. Younger subjects show greater tendency to external attribution. Factor analysis confirms the three-factor hypothesis. The results suggest that the Spanish form of the MHLC has adequate construct validity and acceptable metric properties. Also, they evidence the relationship between the attribution of health-related internal control with the perceived well-being and confidence in their own skills and abilities. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

The Effect Of Digital Unsharp Masking On The Detectability Of Interstitial Infiltrates And Pneumothoraces

NASA Astrophysics Data System (ADS)

MacMahon, Heber; Vyborny, Carl; Sabeti, Victoria; Metz, Charles; Doi, Kunio

1985-09-01

A potential advantage of digital radiographic systems is their ability to enhance images by various types of processing. Digital unsharp masking is one of the simplest and potentially most useful forms of enhancement. The efficacy of unsharp masking in clinical radiologic diagnosis has not been investigated systematically, however. The effect of digital unsharp masking on the detectability of two types of subtle abnormalities, pneumothorax and interstitial infiltrate, was studied in an observer performance test. An ROC analysis of this preliminary data suggests that unsharp masking may improve diagnostic accuracy for pneumothorax. Radiologists' performance in identifying interstitial infiltrates was degraded by the image processing, however, and false positive diagnoses tended to be more frequent.

Expanding Horizons: A Pilot Mentoring Program Linking College/Graduate Students and Teens With ASD.

PubMed

Curtin, Carol; Humphrey, Kristin; Vronsky, Kaela; Mattern, Kathryn; Nicastro, Susan; Perrin, Ellen C

2016-02-01

A small pilot program of 9 youth 13 to 18 years old with high-functioning autism spectrum disorder (ASD) or Asperger's syndrome assessed the feasibility, acceptability, and potential efficacy of an individualized mentoring program. Youth met weekly for 6 months with trained young adult mentors at a local boys and girls club. Participants reported improvements in self-esteem, social anxiety, and quality of life. Participants, parents, mentors, and staff reported that the program improved participants' social connectedness. Although the pilot study was small, it provides preliminary data that mentoring for youth with ASD has promise for increasing self-esteem, social skills, and quality of life. © The Author(s) 2015.

[Effect of measures for the detection and long-term drug therapy of arterial hypertension on the morbidity and work capacity of industrial workers].

PubMed

Evdakov, V A; Baĭda, S M; Britov, A N; Safronova, M B; Grigor'eva, N V

1985-01-01

The article contains data on preliminary evaluation of the efficacy of secondary prevention of arterial hypertension among industrial workers of "Avto ZIL" amalgamation. Population studies to reveal major cardiovascular diseases show a certain increase of arterial hypertension and other disease morbidity accompanied by temporary disability. A considerable positive effect is observed in groups of hypertensives undergoing regular and effective anti-hypertension preventive treatment. Long-term regular hypotensive treatment of hypertensive subjects and the lowering of blood pressure to less than 160/90 mm Hg contributes to the decrease in labour and economic losses and to increased labour productivity of industrial workers.

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

PubMed

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

2016-01-01

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

Three-dimensional structure of human serum albumin

NASA Technical Reports Server (NTRS)

Carter, Daniel C.; He, Xiao-Min; Twigg, Pamela D.; Casale, Elena

1991-01-01

The binding locations to human serum albumin (HSA) of several drug molecules were determined at low resolution using crystallographic methods. The principal binding sites are located within subdomains IIA and IIIA. Preliminary studies suggest that an approach to increasing the in vivo efficacy of drugs which are rendered less effective or ineffective by virtue of their interaction with HSA, would be the use of competitive displacement in drug therapies and/or the development of a general inhibitor to the site within subdomain IIIA. These findings also suggest that the facilitated transfer of various ligands across organ/circulatory interfaces such as liver, kidney, and brain may be associated with binding to the IIIA subdomain.

New cytotoxic natural products from the mangrove biome: covering the period 2007-2015.

PubMed

Pejin, Boris; Glumac, Miodrag

2018-01-15

Nowadays, the mangrove biome is considered to be a profound resource of natural products usually possessing cytotoxicity of a broader range. Covering the period 2007-2015, a total of 21 new naturally occurring compounds has stood out. For example, xylogranin B and swietephragmin C were found to exhibit very potent cytotoxic activity against the colon HCT-116 cells reaching IC 50 values of 0.05 and 0.06 μM, respectively. Bearing in mind the efficacy of the majority compounds in the preliminary in vitro screens, these studies should be expanded to both ex vivo and in vivo screens including the evaluation of the relevant toxicological profiles.

EXPANDING HORIZONS: A PILOT MENTORING PROGRAM LINKING COLLEGE/GRADUATE STUDENTS AND TEENS WITH ASD

PubMed Central

Curtin, Carol; Humphrey, Kristin; Vronsky, Kaela; Mattern, Kathryn; Nicastro, Susan; Perrin, Ellen C.

2015-01-01

A small pilot program of nine youth ages 13–18 with high functioning autism spectrum disorder (ASD) or Asperger’s syndrome assessed the feasibility, acceptability, and potential efficacy of an individualized mentoring program. Youth met weekly for 6 months with trained young adult mentors at a local Boys and Girls Clubs. Participants reported improvements in self-esteem, social anxiety, and quality of life. Participants, parents, mentors, and staff reported that the program improved participants’ social connectedness. While the pilot study was small, it provides preliminary data that mentoring for youth with ASD has promise for increasing self-esteem, social skills, and quality of life. PMID:26016838

Mueller matrix imaging polarimetry in dermatology

NASA Astrophysics Data System (ADS)

Smith, Matthew H.; Burke, Paul D.; Lompado, Arthur; Tanner, Elizabeth A.; Hillman, Lloyd W.

2000-05-01

Recent studies have indicated that polarized light may be useful in the discrimination between benign and malignant moles. In fact, imaging polarimetry could provide noninvasive diagnosis of a range of dermatological disease states. However, in order to design an efficacious sensor for clinical use, the complete polarization-altering properties of a particular disease must be well understood. We present Mueller matrix imaging polarimetry as a technique for characterizing various dermatological diseases. Preliminary Mueller matrix imagery at 633 nm suggests that both malignant moles and lupus lesions may be identified through polarimetric measurements. Malignant moles are found to be less depolarizing than the surrounding tissue, and lupus lesions are found to have rapidly varying retardance orientation.

Systematic review of herbs and dietary supplements for glycemic control in diabetes.

PubMed

Yeh, Gloria Y; Eisenberg, David M; Kaptchuk, Ted J; Phillips, Russell S

2003-04-01

To conduct a systematic review of the published literature on the efficacy and safety of herbal therapies and vitamin/mineral supplements for glucose control in patients with diabetes. We conducted an electronic literature search of MEDLINE, OLDMEDLINE, Cochrane Library Database, and HealthSTAR, from database inception to May 2002, in addition to performing hand searches and consulting with experts in the field. Available clinical studies published in the English language that used human participants and examined glycemic control were included. Data were extracted in a standardized manner, and two independent investigators assessed methodological quality of randomized controlled trials using the Jadad scale. A total of 108 trials examining 36 herbs (single or in combination) and 9 vitamin/mineral supplements, involving 4,565 patients with diabetes or impaired glucose tolerance, met the inclusion criteria and were analyzed. There were 58 controlled clinical trials involving individuals with diabetes or impaired glucose tolerance (42 randomized and 16 nonrandomized trials). Most studies involved patients with type 2 diabetes. Heterogeneity and the small number of studies per supplement precluded formal meta-analyses. Of these 58 trials, the direction of the evidence for improved glucose control was positive in 76% (44 of 58). Very few adverse effects were reported. There is still insufficient evidence to draw definitive conclusions about the efficacy of individual herbs and supplements for diabetes; however, they appear to be generally safe. The available data suggest that several supplements may warrant further study. The best evidence for efficacy from adequately designed randomized controlled trials (RCTs) is available for Coccinia indica and American ginseng. Chromium has been the most widely studied supplement. Other supplements with positive preliminary results include Gymnema sylvestre, Aloe vera, vanadium, Momordica charantia, and nopal.

The South Asian heart lifestyle intervention (SAHELI) study to improve cardiovascular risk factors in a community setting: Design and methods

PubMed Central

Kandula, Namratha R.; Patel, Yasin; Dave, Swapna; Seguil, Paola; Kumar, Santosh; Baker, David W.; Spring, Bonnie; Siddique, Juned

2013-01-01

Disseminating and implementing evidence-based, cardiovascular disease (CVD) prevention lifestyle interventions in community settings and in ethnic minority populations is a challenge. We describe the design and methods for the South Asian heart lifestyle intervention (SAHELI) study, a pilot study designed to determine the feasibility and initial efficacy of a culturally-targeted, community-based lifestyle intervention to improve physical activity and diet behaviors among medically underserved South Asians (SAs). Participants with at least one CVD risk factor will be randomized to either a lifestyle intervention or a control group. Participants in both groups will be screened in a community setting and receive a primary care referral after randomization. Intervention participants will receive 6 weeks of group classes, followed by 12 weeks of individual telephone support where they will be encouraged to initiate and maintain a healthy lifestyle goal. Control participants will receive their screening results and monthly mailings on CVD prevention. Primary outcomes will be changes in moderate/vigorous physical activity and saturated fat intake between baseline, 3-, and 6-month follow-up. Secondary outcomes will be changes in weight, clinical risk factors, primary care visits, self-efficacy, and social support. This study will be one of the first to pilot-test a lifestyle intervention for SAs, one of the fastest growing racial/ethnic groups in the U.S. and one with disparate CVD risk. Results of this pilot study will provide preliminary data about the efficacy of a lifestyle intervention on CVD risk in SAs and inform community-engaged CVD prevention efforts in an increasingly diverse U.S. population. PMID:24060673

Self-Stigma in People With Mental Illness

PubMed Central

Watson, Amy C.; Corrigan, Patrick; Larson, Jonathon E.; Sells, Molly

2007-01-01

Persons with mental illnesses such as schizophrenia may internalize mental illness stigma and experience diminished self-esteem and self-efficacy. In this article, we describe a model of self-stigma and examine a hierarchy of mediational processes within the model. Seventy-one individuals with serious mental illness were recruited from a community support program at an outpatient psychiatry department of a community hospital. All participants completed the Self-Stigma of Mental Illness Scale along with measures of group identification (GI), perceived legitimacy (PL), self-esteem, and self-efficacy. Models examining the steps involved in self-stigma process were tested. Specifically, after conducting preliminary bivariate analyses, we examine stereotype agreement as a mediator of GI and PL on stigma self-concurrence (SSC); SSC as a mediator of GI and PL on self-efficacy; and SSC as a mediator of GI and PL on self-esteem. Findings provide partial support for the proposed mediational processes and point to GI, PL, and stereotype agreement as areas to be considered for intervention. PMID:17255118

Interferon-based treatment of chronic hepatitis C.

PubMed

Souvignet, Claude; Lejeune, Olivier; Trepo, Christian

2007-01-01

The treatment of patients with chronic hepatitis C has rapidly evolved in the past 10 years centered on the use of interferon alpha 2 as an antiviral and immunomodulatory agent against hepatitis C virus. Firstly used as a monotherapy associated with a deceiving long-term efficacy, interferon alpha was then combined with ribavirin, a nucleoside analog with large antiviral properties. Combination of both drugs dramatically improved the efficacy of treatment with 50% of patients reaching a sustained viral response, characterized by the final eradication of the virus from the infected individual. Surprisingly, this synergistic effect remains greatly unexplained. The third step consisted in the use of pegylated interferon in order to adapt its pharmacokinetics and to allow a better efficacy with a more tolerable dosing schedule: once weekly subcutaneous injection instead of thrice weekly. Pegylated interferon combined with ribavirin during 24-48 weeks of treatment is the current standard of care with nearly 60% of sustained virologic response, overall. Development of new forms of interferon alpha are on the way with promising preliminary results.

Utilization of 3-month yoga program for adults at high risk for type 2 diabetes: a pilot study.

PubMed

Yang, Kyeongra; Bernardo, Lisa M; Sereika, Susan M; Conroy, Molly B; Balk, Judy; Burke, Lora E

2011-01-01

Various modes of physical activity, combined with dieting, have been widely recommended to prevent or delay type 2 diabetes. Among these, yoga holds promise for reducing risk factors for type 2 diabetes by promoting weight loss, improving glucose levels and reducing blood pressure and lipid levels. This pilot study aimed to assess the feasibility of implementing a 12-week yoga program among adults at high risk for type 2 diabetes. Twenty-three adults (19 Whites and 4 non-Whites) were randomly assigned to the yoga intervention group or the educational group. The yoga group participated in a 3-month yoga intervention with sessions twice per week and the educational group received general health educational materials every 2 weeks. All participants completed questionnaires and had blood tests at baseline and at the end of 3 months. Effect sizes were reported to summarize the efficacy of the intervention. All participants assigned to the yoga intervention completed the yoga program without complication and expressed high satisfaction with the program (99.2%). Their yoga session attendance ranged from 58.3 to 100%. Compared with the education group, the yoga group experienced improvements in weight, blood pressure, insulin, triglycerides and exercise self-efficacy indicated by small to large effect sizes. This preliminary study indicates that a yoga program would be a possible risk reduction option for adults at high risk for type 2 diabetes. In addition, yoga holds promise as an approach to reducing cardiometabolic risk factors and increasing exercise self-efficacy for this group.

Omega-3 (ω-3) and social skills interventions for reactive aggression and childhood externalizing behavior problems: a randomized, stratified, double-blind, placebo-controlled, factorial trial.

PubMed

Raine, Adrian; Ang, Rebecca P; Choy, Olivia; Hibbeln, Joseph R; Ho, Ringo M-H; Lim, Choon Guan; Lim-Ashworth, Nikki S J; Ling, Shichun; Liu, Jean C J; Ooi, Yoon Phaik; Tan, Yi Ren; Fung, Daniel S S

2018-05-10

While studies suggest that nutritional supplementation may reduce aggressive behavior in children, few have examined their effects on specific forms of aggression. This study tests the primary hypothesis that omega-3 (ω-3), both alone and in conjunction with social skills training, will have particular post-treatment efficacy for reducing childhood reactive aggression relative to baseline. In this randomized, double-blind, stratified, placebo-controlled, factorial trial, a clinical sample of 282 children with externalizing behavior aged 7-16 years was randomized into ω-3 only, social skills only, ω-3 + social skills, and placebo control groups. Treatment duration was 6 months. The primary outcome measure was reactive aggression collected at 0, 3, 6, 9, and 12 months, with antisocial behavior as a secondary outcome. Children in the ω-3-only group showed a short-term reduction (at 3 and 6 months) in self-report reactive aggression, and also a short-term reduction in overall antisocial behavior. Sensitivity analyses and a robustness check replicated significant interaction effects. Effect sizes (d) were small, ranging from 0.17 to 0.31. Findings provide some initial support for the efficacy of ω-3 in reducing reactive aggression over and above standard care (medication and parent training), but yield only preliminary and limited support for the efficacy of ω-3 in reducing overall externalizing behavior in children. Future studies could test further whether ω-3 shows promise in reducing more reactive, impulsive forms of aggression.

Saw Palmetto for Symptom Management During Radiation Therapy for Prostate Cancer.

PubMed

Wyatt, Gwen K; Sikorskii, Alla; Safikhani, Abolfazl; McVary, Kevin T; Herman, James

2016-06-01

Lower urinary tract symptoms (LUTSs) affect 75%-80% of men undergoing radiation therapy (RT) for prostate cancer. To determine the safety, maximum tolerated dose (MTD), and preliminary efficacy of Serenoa repens commonly known as saw palmetto (SP) for management of LUTS during RT for prostate cancer. The dose finding phase used the time-to-event continual reassessment method to evaluate safety of three doses (320, 640, and 960 mg) of SP. Dose-limiting toxicities were assessed for 22 weeks using the Common Terminology Criteria for Adverse Events for nausea, gastritis, and anorexia. The exploratory randomized controlled trial phase assessed preliminary efficacy of the MTD against placebo. The primary outcome of LUTS was measured over 22 weeks using the International Prostate Symptom Score. Additional longitudinal assessments included quality of life measured with the Functional Assessment of Cancer Therapy-Prostate. The dose finding phase was completed by 27 men who reported no dose-limiting toxicities and with 20 participants at the MTD of 960 mg daily. The exploratory randomized controlled trial phase included 21 men, and no statistically significant differences in the International Prostate Symptom Score were observed. The prostate-specific concerns score of the Functional Assessment of Cancer Therapy-Prostate improved in the SP group (P = 0.03). Of 11 men in the placebo group, two received physician-prescribed medications to manage LUTS compared with none of the 10 men in the SP group. SP at 960 mg may be a safe herbal supplement, but its efficacy in managing LUTS during RT needs further investigation. Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Preliminary Investigation of a Mindfulness-Based Intervention for Social Anxiety Disorder That Integrates Compassion Meditation and Mindful Exposure.

PubMed

Koszycki, Diana; Thake, Jennifer; Mavounza, Céline; Daoust, Jean-Philippe; Taljaard, Monica; Bradwejn, Jacques

2016-05-01

This study evaluated the feasibility and initial efficacy of a 12-week group mindfulness-based intervention tailored for persons with social anxiety disorder (MBI-SAD). The intervention includes elements of the standard mindfulness-based stress reduction program, explicit training in self-compassion aimed at cultivating a more accepting and kinder stance toward oneself, and use of exposure procedures to help participants practice responding mindfully to internal experiences evoked by feared social situations. Participants were randomly assigned to the MBI-SAD (n = 21) or a waitlist (WL) (n = 18) control group. Feasibility was assessed by the number of participants who completed at least 75% of the 12 weekly group sessions. Primary efficacy outcomes were clinician- and self-rated measures of social anxiety. Other outcomes included clinician ratings of illness severity and self-rated depression, social adjustment, mindfulness, and self-compassion. The MBI-SAD was acceptable and feasible, with 81% of participants attending at least 75% of sessions. The MBI-SAD fared better than WL in improving social anxiety symptom severity (p ≤ 0.0001), depression (p ≤ 0.05), and social adjustment (p ≤ 0.05). The intervention also enhanced self-compassion (p ≤ 0.05), and facets of mindfulness (observe and aware; p ≤ .05). MBI-SAD treatment gains were maintained at 3-month follow-up. These preliminary findings suggest that an MBI that integrates explicit training in self-compassion and mindful exposure is a feasible and promising intervention for social anxiety disorder. The next step is to compare the MBI-SAD to the gold standard of cognitive-behavior therapy to determine equivalence or noninferiority and to explore mediators and moderators of treatment outcome.

Feasibility, acceptability and preliminary psychological benefits of mindfulness meditation training in a sample of men diagnosed with prostate cancer on active surveillance: results from a randomized controlled pilot trial.

PubMed

Victorson, David; Hankin, Vered; Burns, James; Weiland, Rebecca; Maletich, Carly; Sufrin, Nathaniel; Schuette, Stephanie; Gutierrez, Bruriah; Brendler, Charles

2017-08-01

In a pilot randomized controlled trial, examine the feasibility and preliminary efficacy of an 8-week, mindfulness training program (Mindfulness Based Stress Reduction) in a sample of men on active surveillance on important psychological outcomes including prostate cancer anxiety, uncertainty intolerance and posttraumatic growth. Men were randomized to either mindfulness (n = 24) or an attention control arm (n = 19) and completed self-reported measures of prostate cancer anxiety, uncertainty intolerance, global quality of life, mindfulness and posttraumatic growth at baseline, 8 weeks, 6 months and 12 months. Participants in the mindfulness arm demonstrated significant decreases in prostate cancer anxiety and uncertainty intolerance, and significant increases in mindfulness, global mental health and posttraumatic growth. Participants in the control condition also demonstrated significant increases in mindfulness over time. Longitudinal increases in posttraumatic growth were significantly larger in the mindfulness arm than they were in the control arm. While mindfulness training was found to be generally feasible and acceptable among participants who enrolled in the 8-week intervention as determined by completion rates and open-ended survey responses, the response rate between initial enrollment and the total number of men approached was lower than desired (47%). While larger sample sizes are necessary to examine the efficacy of mindfulness training on important psychological outcomes, in this pilot study posttraumatic growth was shown to significantly increase over time for men in the treatment group. Mindfulness training has the potential to help men cope more effectively with some of the stressors and uncertainties associated with active surveillance. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Efficacy of osmotic-release oral system (OROS) methylphenidate for mothers with attention-deficit/hyperactivity disorder (ADHD): preliminary report of effects on ADHD symptoms and parenting.

PubMed

Chronis-Tuscano, Andrea; Seymour, Karen E; Stein, Mark A; Jones, Heather A; Jiles, Cynthia D; Rooney, Mary E; Conlon, Charles J; Efron, Lisa A; Wagner, Stephanie A; Pian, Jessica; Robb, Adelaide S

2008-12-01

A preliminary study to examine the efficacy of osmotic-release oral system (OROS) methylphenidate for attention-deficit/hyperactivity disorder (ADHD) symptoms and parenting behaviors in mothers with ADHD who had children with ADHD. Participants included 23 mother-child dyads in which both were diagnosed with DSM-IV ADHD. Mothers underwent a 5-week, double-blind titration (placebo, 36 mg/day, 54 mg/day, 72 mg/day, 90 mg/day) to an optimal dose of OROS methylphenidate, followed by random assignment to 2 weeks of placebo or their maximally effective dose. Primary outcome measures included maternal ADHD symptoms (Conners' Adult ADHD Rating Scale) and parenting (Alabama Parenting Questionnaire). Secondary outcomes included side effects ratings. Data were collected from December 2004 until August 2006. During Phase 1, mothers reported significant decreases in inattention (p < .001) and hyperactivity/impulsivity (p < .01) with increases in OROS methylphenidate dose. As dose increased, significant reductions in inconsistent discipline (p < .01) and corporal punishment use (p < .005) were also demonstrated. During Phase 2, small effects on inattention (d = 0.46) and hyperactivity/impulsivity (d = 0.38) were found for those randomly assigned to medication versus placebo. In addition, medium to large medication effects were found on maternal involvement (d = 0.52), poor monitoring/supervision (d = 0.70), and inconsistent discipline (d = 0.71), with small effects on corporal punishment (d = 0.42). During both phases, few adverse effects were noted. OROS methylphenidate was well tolerated and was associated with significant improvement in maternal ADHD symptoms and parenting. Variable effects on parenting suggest that behavioral interventions may be necessary to address impairments in parenting among adults with ADHD. clinicaltrials.gov Identifier: NCT00318981. Copyright 2008 Physicians Postgraduate Press, Inc.

Feasibility of delivering evidence-based HIV/STI prevention programming to a community sample of African American teen girls via the internet.

PubMed

Danielson, Carla Kmett; McCauley, Jenna L; Jones, Andrea M; Borkman, April L; Miller, Stephanie; Ruggiero, Kenneth J

2013-10-01

The current study examined the feasibility of an HIV/STI prevention intervention for African American female adolescents. The intervention SiHLEWeb is a web-based adaptation of the evidence-based intervention, Sistas, Informing, Healing, Living, and Empowering (SiHLE). Participants were 41 African American girls aged 13 to 18 years, recruited in collaboration with community partners (local high schools, Department of Juvenile Justice, child advocacy center, medical university). Results support the feasibility of recruitment, screening, and follow-up retention methods. The majority (63.4%) of recruited participants completed the intervention, taking an average of 4.5 (SD = 3.63) site visits. Completers of SiHLEWeb demonstrated increases in knowledge regarding HIV/STI risks and risk reduction behavior [t(18) = 4.74, p < .001], as well as significant increases in condom use self-efficacy [t(16) = 2.41, p = .03]. Findings provide preliminary support for the large-scale, randomized-controlled trial of the efficacy of SiHLEWeb to reduce high-risk sexual behavior among female African American adolescents.

Buprenorphine implants in medical treatment of opioid addiction.

PubMed

Chavoustie, Steven; Frost, Michael; Snyder, Ole; Owen, Joel; Darwish, Mona; Dammerman, Ryan; Sanjurjo, Victoria

2017-08-01

Opioid use disorder is a chronic, relapsing disease that encompasses use of both prescription opioids and heroin and is associated with a high annual rate of overdose deaths. Medical treatment has proven more successful than placebo treatment or psychosocial intervention, and the partial µ-opioid receptor agonist and κ-opioid receptor antagonist buprenorphine is similar in efficacy to methadone while offering lower risk of respiratory depression. However, frequent dosing requirements and potential for misuse and drug diversion contribute to significant complications with treatment adherence for available formulations. Areas covered: This review describes the development of and preliminary data from clinical trials of an implantable buprenorphine formulation. Efficacy and safety data from comparative studies with other administrations of buprenorphine, including tablets and sublingual film, will be described. Key premises of the Risk Evaluation and Mitigation Strategy program for safely administering buprenorphine implants, which all prescribing physicians must complete, are also discussed. Expert commentary: Long-acting implantable drug formulations that offer consistent drug delivery and lower risk of misuse, diversion, or accidental pediatric exposure over traditional formulations represent a promising development for the effective treatment of opioid use disorder.

Systematic cultural adaptation of cognitive-behavioral therapy to reduce alcohol use among HIV-infected outpatients in western Kenya

PubMed Central

Sidle, John E.; Martino, Steve; Baliddawa, Joyce B.; Songole, Rogers; Omolo, Otieno E.; Gakinya, Benson N.; Mwaniki, Michael M.; Adina, Japheth O.; Nafula, Tobista; Owino-Ong’or, Willis D.; Bryant, Kendall J.; Carroll, Kathleen M.; Goulet, Joseph L.; Justice, Amy C.; Maisto, Stephen A.

2010-01-01

Two-thirds of those with HIV worldwide live in sub-Saharan Africa. Alcohol use is associated with the HIV epidemic through risky sex and suboptimal ARV adherence. In western Kenya, hazardous drinking was reported by HIV (53%) and general medicine (68%) outpatients. Cognitive behavioral treatment (CBT) has demonstrated strong efficacy to reduce alcohol use. This article reports on a systematic cultural adaptation and pilot feasibility study of group paraprofessional-delivered CBT to reduce alcohol use among HIV-infected outpatients in Eldoret, Kenya. Following adaptation and counselor training, five pilot groups were run (n=27). Overall attendance was 77%. Percent days abstinent from alcohol (PDA) before session 1 was 52%–100% (women) and 21–36% (men), and by session 6 was 96%–100% (women) and 89%–100% (men). PDA effect sizes (Cohen’s d) between first and last CBT session were 2.32 (women) and 2.64 (men). Participants reported treatment satisfaction. Results indicate feasibility, acceptability and preliminary efficacy for CBT in Kenya. PMID:19967441

Melanoma Brain Metastasis: Mechanisms, Models, and Medicine

PubMed Central

Kircher, David A.; Silvis, Mark R.; Cho, Joseph H.; Holmen, Sheri L.

2016-01-01

The development of brain metastases in patients with advanced stage melanoma is common, but the molecular mechanisms responsible for their development are poorly understood. Melanoma brain metastases cause significant morbidity and mortality and confer a poor prognosis; traditional therapies including whole brain radiation, stereotactic radiotherapy, or chemotherapy yield only modest increases in overall survival (OS) for these patients. While recently approved therapies have significantly improved OS in melanoma patients, only a small number of studies have investigated their efficacy in patients with brain metastases. Preliminary data suggest that some responses have been observed in intracranial lesions, which has sparked new clinical trials designed to evaluate the efficacy in melanoma patients with brain metastases. Simultaneously, recent advances in our understanding of the mechanisms of melanoma cell dissemination to the brain have revealed novel and potentially therapeutic targets. In this review, we provide an overview of newly discovered mechanisms of melanoma spread to the brain, discuss preclinical models that are being used to further our understanding of this deadly disease and provide an update of the current clinical trials for melanoma patients with brain metastases. PMID:27598148

Comparing the effects of combined numerical and visuo- spatial psychoeducational trainings conducted by curricular teachers and external trainers. Preliminary evidence across kindergarteners.

NASA Astrophysics Data System (ADS)

Agus, M.; Mascia, M. L.; Fastame, M. C.; Napoleone, V.; Porru, A. M.; Siddu, F.; Lucangeli, D.; Penna, M. P.

2016-11-01

The aim of this study was to verify the efficacy of two pencil-and-paper trainings empowering numerical and visuo-spatial abilities in Italian five-year-old kindergarteners. Specifically, the trainings were respectively carried out by the curricular teacher or by an external trainer. The former received a specific training in order to use the psychoeducational programmes with her pupils, whereas the latter received a specific education about the role of numerical and visuo-spatial abilities for school achievement and she was also trained to use psychoeducational trainings in kindergarten schools. At pre-test and post-test nonverbal functions and numeracy knowledge were assessed through a battery of standardized tests. The results show that both the numerical psychoeducational programme and the visuo-spatial one are useful tools to enhance mathematical achievements in kindergarteners. However, when the trainings were proposed by the external trainer, the efficacy of the psychoeducational programmes was more significant. These outcomes seem to be related both to the expertise and the novelty effect of the external trainer on the classroom.

Evaluation of an HIV/STD Sexual Risk-Reduction Intervention for Pregnant African American Adolescents Attending a Prenatal Clinic in an Urban Public Hospital: Preliminary Evidence of Efficacy

PubMed Central

Diclemente, R.J.; Wingood, G. M.; Rose, E.; Sales, J. M.; Crosby, R.A.

2009-01-01

Study Objective To evaluate an intervention to reduce HIV/STD-associated behaviors and enhance psychosocial mediators for pregnant African-American adolescents. Design A randomized controlled trial. Participants completed baseline and follow-up assessments. Setting An urban public hospital in the Southeastern U.S. Participants Pregnant African-American adolescents (N=170), 14-20 years of age, attending a prenatal clinic. Intervention Intervention participants received two 4-hour group sessions enhancing self-concept and self-worth, HIV/STD prevention skills, and safer sex practices. Participants in the comparison condition received a 2-hour session on healthy nutrition. Main Outcome Measures Consistent condom use. Results Intervention participants reported greater condom use at last intercourse (AOR = 3.9, P = .05) and consistent condom use (AOR = 7.9, P = .05), higher sexual communication frequency, enhanced ethnic pride, higher self-efficacy to refuse risky sex, and were less likely to fear abandonment as a result of negotiating safer sex. Conclusion Interventions for pregnant African-American adolescents can enhance condom use and psychosocial mediators. PMID:19643646

Targeted Behavioral Therapy for childhood generalized anxiety disorder: a time-series analysis of changes in anxiety and sleep.

PubMed

Clementi, Michelle A; Alfano, Candice A

2014-03-01

This study examined the efficacy of Targeted Behavioral Therapy (TBT), a newly developed intervention targeting features of childhood generalized anxiety disorder (GAD). Using a time-series design, 4 children (7-12 years) with primary GAD were treated with TBT, which includes sleep improvement strategies, systematic desensitization for reducing intolerance of uncertainty, and in vivo exposures for anxiety. Diagnostic interviews and questionnaires were administered at baseline, post-treatment and 3 months follow-up. Anxiety symptoms and sleep characteristics/problems were rated weekly during a 4-week baseline and 14-weeks of treatment. Two children remitted at post-treatment and no child had a GAD diagnosis at follow-up. Child but not parent report revealed improvements in both worry and sleep. Despite improvements from pre- to post-assessment, considerable symptom fluctuation observed during the baseline period preclude conclusion that symptom changes are specifically attributable to the course of treatment. Overall, preliminary support is provided for the efficacy of TBT for childhood GAD. Copyright © 2013 Elsevier Ltd. All rights reserved.

The Adolescent HIV Disclosure Cognition and Affect Scale: Preliminary Reliability and Validity.

PubMed

Evangeli, Michael

2017-07-01

Globally, there are 2 million HIV-positive 10-19-year-olds. One challenge for this population is sharing their HIV status with others (onward HIV disclosure). There are no multi-item, multidimensional scales of HIV disclosure cognitions and affect for young people living with HIV. An 18-item measure of HIV disclosure cognition and affect was developed, administered to 65 adolescents living with HIV (aged 12-16 years). Data were explored using principal component analysis and preliminary construct and criterion validity assessed. Three factors were revealed: negative disclosure attitudes and feelings, self-efficacy, and positive disclosure attitudes and feelings. The full scale and its subscales were internally consistent. The total score showed statistically significant positive relationships with HIV disclosure in the past 6 months, HIV disclosure intention and self-perception. Preliminary evidence of the measure's good psychometric properties suggests it may be helpful in future clinical and research work. © The Author 2017. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

A multicontext approach to promoting transfer of strategy use and self regulation after brain injury: An exploratory study.

PubMed

Toglia, Joan; Johnston, Mark V; Goverover, Yael; Dain, Barry

2010-01-01

Persons with brain injury frequently demonstrate decreased ability to monitor and apply strategies learned in treatment to everyday situations. The aim of this study is to refine, explore and provide preliminary testing of the multicontext approach in promoting strategy use across situations and increasing self-regulation, awareness and functional performance. This study used a single-subject design with repeated measures pre- and post-intervention, with data analysed descriptively and graphically. Four persons with difficulty following multi-step directions, 3-5 years post-TBI, received a nine session intervention programme. Outcome measures included the Awareness Questionnaire, Self-Regulation Skills Interview, Behavior Rating Inventory of Executive Function, Multiple Errands Test and an Executive Function Performance Test sub-task. The process of change within each treatment session was examined with strategy and awareness ratings. All participants demonstrated positive changes in self-regulatory skills and strategy use that was observed across tasks. As expected, general awareness of deficits remained unchanged. Examination of individual participants revealed important, varying patterns of change in strategy use, learning transfer and self-awareness across intervention. Results provide preliminary support for the feasibility and efficacy of the multicontext approach in promoting transfer of strategy use to enhance functional performance and selective aspects of awareness. Further investigation, including a larger controlled study, is needed to confirm or limit these observations.

Feasibility and Preliminary Effects of a Virtual Environment for Adults With Type 2 Diabetes: Pilot Study

PubMed Central

Feinglos, Mark; Pereira, Katherine; Hassell, Nancy; Blascovich, Jim; Nicollerat, Janet; Beresford, Henry F; Levy, Janet; Vorderstrasse, Allison

2014-01-01

Background Innovative interventions that empower patients in diabetes self-management (DSM) are needed to provide accessible, sustainable, cost-effective patient education and support that surpass current noninteractive interventions. Skills acquired in digital virtual environments (VEs) affect behaviors in the physical world. Some VEs are programmed as real-time three-dimensional representations of various settings via the Internet. For this research, a theoretically grounded VE that facilitates DSM was developed and pilot tested. It offered weekly synchronous DSM education classes, group meetings, and social networking in a community in which participants practiced real world skills such as grocery shopping, exercising, and dining out, allowing for interactive knowledge application. The VE was available 24/7 on the Internet, minimizing access barriers. Objective The objective of this study was to evaluate the feasibility and efficacy of participation in a VE for DSM education and support. Methods This study utilized a single group, pre-mid-post measure design. At 0, 3, and 6 months, we assessed participants’ perceived VE usability and usefulness, self-efficacy, diabetes self-management behaviors, perceived social support, and diabetes knowledge using validated survey measures; and we recorded metabolic indicators (HbA1c, BP, BMI). Process data were continuously collected in the VE (log-ins, voice recordings, locations visited, objects interacted with, and movement). Data analysis included descriptive statistics, t tests to evaluate changes in mediators and outcomes over time, and depiction of utilization and movement data. Results We enrolled 20 participants (13/20, 65% white, 7/20, 35% black), with an age range of 39-72 years (mean age, 54 years) and diabetes duration from 3 months to 25 years. At baseline, 95% (18/19) and 79% (15/19) of participants rated usefulness and ease of use as high on validated surveys with no significant changes at 3 or 6 months. Participants logged into the site a mean of 2.5 hours/week over the course of 6 months. High DSM class attendance was reflected by the largest percentage of time spent in the classroom (48.6%). Self-efficacy, social support, and foot care showed significant improvement (P<.05). There were improvement trends in clinical outcomes that were clinically meaningful but did not reach statistical significance given the small sample size. Conclusions Because relatively little is known about usability, acceptability, and efficacy of health interventions in VEs, this study constitutes an important, innovative first step in exploring the potential of VEs for facilitating DSM. The preliminary data suggest that VEs provide a feasible and useful platform for patients and educators that affects self-management and related mediators. Flexible access to both synchronous and asynchronous diabetes education, skill building activities, and support from a home computer remove barriers to attending clinic-based meetings. This program has potential for improving DSM in an easily disseminated alternative model. PMID:24713420

Feasibility and preliminary effects of a virtual environment for adults with type 2 diabetes: pilot study.

PubMed

Johnson, Constance; Feinglos, Mark; Pereira, Katherine; Hassell, Nancy; Blascovich, Jim; Nicollerat, Janet; Beresford, Henry F; Levy, Janet; Vorderstrasse, Allison

2014-04-08

Innovative interventions that empower patients in diabetes self-management (DSM) are needed to provide accessible, sustainable, cost-effective patient education and support that surpass current noninteractive interventions. Skills acquired in digital virtual environments (VEs) affect behaviors in the physical world. Some VEs are programmed as real-time three-dimensional representations of various settings via the Internet. For this research, a theoretically grounded VE that facilitates DSM was developed and pilot tested. It offered weekly synchronous DSM education classes, group meetings, and social networking in a community in which participants practiced real world skills such as grocery shopping, exercising, and dining out, allowing for interactive knowledge application. The VE was available 24/7 on the Internet, minimizing access barriers. The objective of this study was to evaluate the feasibility and efficacy of participation in a VE for DSM education and support. This study utilized a single group, pre-mid-post measure design. At 0, 3, and 6 months, we assessed participants' perceived VE usability and usefulness, self-efficacy, diabetes self-management behaviors, perceived social support, and diabetes knowledge using validated survey measures; and we recorded metabolic indicators (HbA1c, BP, BMI). Process data were continuously collected in the VE (log-ins, voice recordings, locations visited, objects interacted with, and movement). Data analysis included descriptive statistics, t tests to evaluate changes in mediators and outcomes over time, and depiction of utilization and movement data. We enrolled 20 participants (13/20, 65% white, 7/20, 35% black), with an age range of 39-72 years (mean age, 54 years) and diabetes duration from 3 months to 25 years. At baseline, 95% (18/19) and 79% (15/19) of participants rated usefulness and ease of use as high on validated surveys with no significant changes at 3 or 6 months. Participants logged into the site a mean of 2.5 hours/week over the course of 6 months. High DSM class attendance was reflected by the largest percentage of time spent in the classroom (48.6%). Self-efficacy, social support, and foot care showed significant improvement (P<.05). There were improvement trends in clinical outcomes that were clinically meaningful but did not reach statistical significance given the small sample size. Because relatively little is known about usability, acceptability, and efficacy of health interventions in VEs, this study constitutes an important, innovative first step in exploring the potential of VEs for facilitating DSM. The preliminary data suggest that VEs provide a feasible and useful platform for patients and educators that affects self-management and related mediators. Flexible access to both synchronous and asynchronous diabetes education, skill building activities, and support from a home computer remove barriers to attending clinic-based meetings. This program has potential for improving DSM in an easily disseminated alternative model.

Adherence to cognitive behavioral therapy for insomnia (CBTI) among women following primary breast cancer treatment: a pilot study.

PubMed

Matthews, Ellyn E; Schmiege, Sarah J; Cook, Paul F; Berger, Ann M; Aloia, Mark S

2012-01-01

Cognitive behavioral therapy for insomnia (CBTI) has proven efficacy, yet 32%-89% of patients fail to consistently follow recommendations. This pilot study examines adherence to CBTI in breast cancer survivors with insomnia. There was a significant decline in adherence to prescribed rise time, and total time in bed, but no change in adherence to prescribed bedtime during six weekly sessions. Factors associated with higher adherence included lower fatigue and higher baseline motivation. Higher adherence was associated with worse subjective sleep quality at the beginning of CBTI and fewer nocturnal awakenings at the end of treatment. Results provide preliminary evidence supporting the impact of adherence on sleep outcomes such as fewer nocturnal awakenings. Attention to adherence as part of CBTI may yield greater sleep improvements.

Duloxetine, an antidepressant with analgesic properties – a preliminary analysis

PubMed Central

Onuţu, Adela Hilda

2015-01-01

Serotonin and norepinephrine reuptake inhibitors are second-line antidepressants largely used because of their good tolerance and their reduced side effects. Two of these drugs, duloxetine and venlafaxine, are used also in chronic pain management. In this review we present recent data regarding duloxetine’s effects on the central nervous system, linked to acute pain management, and their efficiency in reducing postoperative chronic pain. The drug’s efficacy results from its modulating effect on the descending inhibitory pain pathways and the inhibition of the nociceptive input. There are already several studies in favor of the analgesic properties of duloxetine. However, further and larger randomized studies are necessary in order to clarify duloxetine efficiency in acute postoperative settings, and thereafter on persistent chronic postoperative pain. PMID:28913467

Crisaborole and its potential role in treating atopic dermatitis: overview of early clinical studies.

PubMed

Zane, L T; Chanda, S; Jarnagin, K; Nelson, D B; Spelman, L; Gold, Lf Stein

2016-07-01

Atopic dermatitis (AD), a chronic, relapsing, inflammatory skin disease that is characterized by intense pruritus and eczematous lesions with up to 90% of patients presenting with mild to moderate disease. Current topical treatments for AD have not changed in over 15 years and are associated with safety concerns. In AD, overactivity of phosphodiesterase 4 (PDE4), leads to inflammation and disease exacerbation. Crisaborole Topical Ointment, 2%, is a novel, nonsteroidal, topical anti-inflammatory PDE4 inhibitor currently being investigated for the treatment of mild to moderate AD. Preliminary studies in children and adults demonstrated favorable efficacy and safety profiles. Crisaborole may represent an anti-inflammatory option that safely minimizes the symptoms and severity of AD and that can be used for both acute and long-term management.