A prospective, multicenter pilot study to investigate the feasibility and safety of a 1-year controlled exercise training after adjuvant chemotherapy in colorectal cancer patients.

Science.gov (United States)

Piringer, Gudrun; Fridrik, Michael; Fridrik, Alfred; Leiherer, Andreas; Zabernigg, August; Greil, Richard; Eisterer, Wolfgang; Tschmelitsch, Jörg; Lang, Alois; Frantal, Sophie; Burgstaller, Sonja; Gnant, Michael; Thaler, Josef

2018-04-01

Despite advances in adjuvant chemotherapy, 20-30% of patients in stages II-III colorectal cancer will eventually relapse. Observational studies showed a reduction in relapse rate, colon cancer-specific mortality, and overall mortality by physical activity. Results from prospective randomized interventional studies to confirm these observational data are lacking. The aims of this prospective single-arm multicenter pilot study are to evaluate feasibility and safety of exercise training after adjuvant chemotherapy in colorectal cancer patients. The training was performed three times per week for 1 year and was increased gradually in three phases until reaching 18 metabolic equivalent task hours per week. Overall, 30 patients were included. The planned training intensity could be achieved in all three phases. Patients experienced a performance increase of median 35.5 watt, a weight-loss of a median of 3.0 kg, and a reduction in body fat content of median 1.0% during this exercise training. The analysis showed early study termination due to non-compliance in 10/30 patients (33.3%), disease progression in 4 patients (13.3%), and serious adverse events in 2 patients (6.7%). About half of patients (46.7%) completed the pilot study as planned. Biomarker analysis from 20 patients showed a non-significant reduction in insulin-like growth factor 1 (IGF-1), insulin-like growth factor 2 (IGF-2) and insulin-like growth factor binding protein 3 (IGF-BP3) levels, significant increases in adiponectin and leptin levels, and a non-significant increase in C-peptide levels. Exercise training is feasible in patients with colorectal cancer after completion of adjuvant chemotherapy. The main problem encountered during the study was compliance. To improve compliance of exercise training, several measures were adapted for the upcoming prospective randomized ABCSG C08 Exercise II study.

Pilot Randomized Trial Comparing Intersession Scheduling of Biofeedback Results to Individuals with Chronic Pain: Influence on Psychologic Function and Pain Intensity.

Science.gov (United States)

Weeks, Douglas L; Whitney, Anthony A; Tindall, Angelique G; Carter, Gregory T

2015-10-01

The objective of this study was to compare the effectiveness of two biofeedback schedules on long-term improvement in physical and psychologic reactivity to chronic nonmalignant pain. This study is a prospective, randomized pilot trial. Twenty adults with chronic pain engaged in heart rate variability (HRV) biofeedback training for nine sessions with HRV presented visually. Two groups, formed by random assignment, were compared: The faded feedback group received concurrent visual HRV biofeedback in session 1, with the amount of biofeedback systematically reduced for ensuing sessions so that, by session 9, the participants were controlling HRV without external feedback. The full feedback group received visual HRV biofeedback continuously across all sessions. Outcome measures assessed at baseline, immediately after the program, and 3 mos after the program included pain intensity, fear-avoidance beliefs, and self-report physical functioning. Use of biofeedback skills was also assessed 3 mos after the program. Nominal variables were analyzed with χ. Continuous measures were analyzed with repeated-measures analyses of variance. The faded feedback schedule resulted in greater use of biofeedback skills at 3 mos and improved pain intensity and fear-avoidance beliefs after the program and at 3 mos. Physical functioning did not differ between groups. Systematically reducing the frequency of external visual feedback during HRV biofeedback training was associated with reduced reactivity to chronic pain. Results of this pilot study should be confirmed with a larger randomized study.

Spinal Orthoses: The Crucial Role of Comfort on Compliance of Wearing - Monocentric Prospective Pilot Study of Randomized Cross-Over Design.

Science.gov (United States)

Herget, G W; Patermann, S; Strohm, P C; Zwingmann, J; Eichelberger, P; Südkamp, N P; Hirschmüller, A

2017-01-01

PURPOSE OF THE STUDY Various spine disorders are regularly treated by orthoses, and success of treatment depends on wearing these devices. In this study we examined the compliance, wear comfort, subjective stabilization and side effects associated with spinal orthoses using an individualized questionnaire and the Compact Short Form-12 Health Survey (SF-12). MATERIAL AND METHODS In this prospective pilot study of randomized cross-over design, twelve healthy volunteers with a mean age of 31.2 years wore three different types of orthoses, each for one week: A hyperextension brace (HB), a custom-made semirigid orthosis (SO) and a custom-made rigid orthosis (RO). The daily duration of wearing the orthosis was defined as primary endpoint; contentment was measured using an individualized questionnaire and the standardized SF-12. RESULTS In the study population calculated probability of wearing the HB and RO was between 0.2 und 38.5% (95% confidence interval). No volunteer wore the SO orthosis for the predefined time. The SO and RO each displayed high subjective stabilization, while the RO was more often associated with side effects like skin pressure marks than the SO. The need for rework due to discomfort was mainly necessary with the RO. We observed no substantial differences in feeling compression and sweating. Noteworthy, eight of 12 subjects complained of uncomfortable sternal pressure due to the upper pad of the HB. The SF-12: scores ranged from 52.1 to 48.6 on the physical (PCS), and from 53.7 to 50.8 on the mental component score (MCS), demonstrating an influence on QoL. DISCUSSION AND CONCLUSIONS The design as well as the orthosis itself influence the compliance of wearing and exert a moderate negative, but acceptable impact on QoL. The SO appeared to correlate with the best overall compromise between comfort and subjective stabilization. Further investigations are necessary in patients with spinal diseases, for whom the effect of orthosis wearing may surpass the

Natalizumab stabilizes physical, cognitive, MRI, and OCT markers of disease activity: A prospective, non-randomized pilot study.

Directory of Open Access Journals (Sweden)

Garrick D Talmage

Full Text Available Natalizumab is an effective therapy for multiple sclerosis (MS. Its effectiveness has been demonstrated in several clinical and imaging studies. The objective of this study was to further demonstrate the efficacy of natalizumab using a comprehensive battery of clinical and imaging markers in the same cohort of patients followed longitudinally, hence capturing the multi-faceted nature of the MS disease process. A prospective, open-label, pilot study of 20 MS patients treated with natalizumab was conducted. High resolution MRI, Symbol-Digit Modalities Test (SDMT, and Optical Coherence Tomography (OCT scans were obtained at baseline, 48, and 96 weeks. 15 patients completed the study. Natalizumab treatment decreased Expanded Disability Status Scale score (EDSS and no change in SDMT, Brain Parenchymal Fraction (BPF, or any of the OCT markers of retinal degeneration was observed. Thalamic and whole brain volume as assessed by Percentage Brain Volume Change (PBVC showed continuous deterioration. Higher baseline T2 lesion load correlated with increased rate of PBVC at 96-weeks (r = 0.566, R2 = 0.320, p = 0.035 and thalamic volume loss (r = -0.586, R2 = 0.344, p = 0.027. Most patients, 93%, achieved no evidence of disease activity (NEDA at 2 years, likely due to early disease duration and lower initial baseline lesion load. This study further demonstrates stabilization of clinical and imaging markers of disease activity during natalizumab treatment.

Occlusion of the pancreatic duct versus pancreaticojejunostomy: a prospective randomized trial.

NARCIS (Netherlands)

K.T. Tran; C.H.J. van Eijck (Casper); V. di Carlo (Valerio); W.C.J. Hop (Wim); A. Zerbi (Alessandro); G. Balzano (Gianpaolo); J. Jeekel (Hans)

2002-01-01

textabstractOBJECTIVE: Using a prospective randomized study to assess postoperative morbidity and pancreatic function after pancreaticoduodenectomy with pancreaticojejunostomy and duct occlusion without pancreaticojejunostomy. SUMMARY BACKGROUND DATA: Postoperative complications

EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial

Science.gov (United States)

Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara

2013-01-01

Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…

A Prospective, Randomized, Double-blind Clinical Trial of One Nano ...

African Journals Online (AJOL)

2015-12-16

Dec 16, 2015 ... prospective randomized clinical trial that evaluated the clinical performance of one high‑viscosity bulk‑fill composite resin in Class II cavities of posterior teeth. .... amount of glass ionomer needed was used to cover the calcium ...

Treatment of asymptomatic vaginal candidiasis in pregnancy to prevent preterm birth: an open-label pilot randomized controlled trial

Directory of Open Access Journals (Sweden)

Rickard Kristen

2011-03-01

Full Text Available Abstract Background Although the connection between ascending infection and preterm birth is undisputed, research focused on finding effective treatments has been disappointing. However evidence that eradication of Candida in pregnancy may reduce the risk of preterm birth is emerging. We conducted a pilot study to assess the feasibility of conducting a large randomized controlled trial to determine whether treatment of asymptomatic candidiasis in early pregnancy reduces the incidence of preterm birth. Methods We used a prospective, randomized, open-label, blinded-endpoint (PROBE study design. Pregnant women presenting at Candida were randomized to 6-days of clotrimazole vaginal pessaries (100mg or usual care (screening result is not revealed, no treatment. The primary outcomes were the rate of asymptomatic vaginal candidiasis, participation and follow-up. The proposed primary trial outcome of spontaneous preterm birth Results Of 779 women approached, 500 (64% participated in candidiasis screening, and 98 (19.6% had asymptomatic vaginal candidiasis and were randomized to clotrimazole or usual care. Women were not inconvenienced by participation in the study, laboratory testing and medication dispensing were problem-free, and the follow-up rate was 99%. There was a tendency towards a reduction in spontaneous preterm birth among women with asymptomatic candidiasis who were treated with clotrimazole RR = 0.33, 95%CI 0.04-3.03. Conclusions A large, adequately powered, randomized trial of clotrimazole to prevent preterm birth in women with asymptomatic candidiasis is both feasible and warranted. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR: ACTRN12609001052224

Cognitive-behavioural suicide prevention for male prisoners: a pilot randomized controlled trial.

Science.gov (United States)

Pratt, D; Tarrier, N; Dunn, G; Awenat, Y; Shaw, J; Ulph, F; Gooding, P

2015-12-01

Prisoners have an exceptional risk of suicide. Cognitive-behavioural therapy for suicidal behaviour has been shown to offer considerable potential, but has yet to be formally evaluated within prisons. This study investigated the feasibility of delivering and evaluating a novel, manualized cognitive-behavioural suicide prevention (CBSP) therapy for suicidal male prisoners. A pilot randomized controlled trial of CBSP in addition to treatment as usual (CBSP; n = 31) compared with treatment as usual (TAU; n = 31) alone was conducted in a male prison in England. The primary outcome was self-injurious behaviour occurring within the past 6 months. Secondary outcomes were dimensions of suicidal ideation, psychiatric symptomatology, personality dysfunction and psychological determinants of suicide, including depression and hopelessness. The trial was prospectively registered (number ISRCTN59909209). Relative to TAU, participants receiving CBSP therapy achieved a significantly greater reduction in suicidal behaviours with a moderate treatment effect [Cohen's d = -0.72, 95% confidence interval -1.71 to 0.09; baseline mean TAU: 1.39 (S.D. = 3.28) v. CBSP: 1.06 (S.D. = 2.10), 6 months mean TAU: 1.48 (S.D. = 3.23) v. CBSP: 0.58 (S.D. = 1.52)]. Significant improvements were achieved on measures of psychiatric symptomatology and personality dysfunction. Improvements on psychological determinants of suicide were non-significant. More than half of the participants in the CBSP group achieved a clinically significant recovery by the end of therapy, compared with a quarter of the TAU group. The delivery and evaluation of CBSP therapy within a prison is feasible. CBSP therapy offers significant promise in the prevention of prison suicide and an adequately powered randomized controlled trial is warranted.

Oncology E-Learning for Undergraduate. A Prospective Randomized Controlled Trial.

Science.gov (United States)

da Costa Vieira, René Aloisio; Lopes, Ana Helena; Sarri, Almir José; Benedetti, Zuleica Caulada; de Oliveira, Cleyton Zanardo

2017-06-01

The e-learning education is a promising method, but there are few prospective randomized publications in oncology. The purpose of this study was to assess the level of retention of information in oncology from undergraduate students of physiotherapy. A prospective, controlled, randomized, crossover study, 72 undergraduate students of physiotherapy, from the second to fourth years, were randomized to perform a course of physiotherapy in oncology (PHO) using traditional classroom or e-learning. Students were offered the same content of the subject. The teacher in the traditional classroom model and the e-learning students used the Articulate® software. The course tackled the main issues related to PHO, and it was divided into six modules, 18 lessons, evaluated by 126 questions. A diagnosis evaluation was performed previous to the course and after every module. The sample consisted of 67 students, allocated in groups A (n = 35) and B (n = 32), and the distribution was homogeneous between the groups. Evaluating the correct answers, we observed a limited score in the pre-test (average grade 44.6 %), which has significant (p e-learning, a fact that encourages the use of e-learning in oncology. REBECU1111-1142-1963.

Auricular Point Acupressure to Manage Chronic Low Back Pain in Older Adults: A Randomized Controlled Pilot Study

Directory of Open Access Journals (Sweden)

Chao Hsing Yeh

2014-01-01

Full Text Available This prospective, randomized clinical trial (RCT pilot study was designed to (1 assess the feasibility and tolerability of an easily administered, auricular point acupressure (APA intervention and (2 provide an initial assessment of effect size as compared to a sham treatment. Thirty-seven subjects were randomized to receive either the real or sham APA treatment. All participants were treated once a week for 4 weeks. Self-report measures were obtained at baseline, weekly during treatment, at end-of-intervention (EOI, and at a 1-month follow-up. A dropout rate of 26% in the real APA group and 50% in the sham group was observed. The reduction in worst pain from baseline to EOI was 41% for the real and 5% for the sham group with a Cohen’s effect size of 1.22 P<0.00. Disability scores on the Roland Morris Disability Questionnaire (RMDQ decreased in the real group by 29% and were unchanged in the sham group (+3% P<0.00. Given the high dropout rate, results must be interpreted with caution; nevertheless, our results suggest that APA may provide an inexpensive and effective complementary approach for the management of back pain in older adults, and further study is warranted.

A prospective randomized trial of Kotase ® (Bromelain + Trypsin) in ...

African Journals Online (AJOL)

International Journal of Medicine and Health Development. Journal Home · ABOUT THIS ... A prospective randomized trial of Kotase® (Bromelain + Trypsin) in the management of post-operative abdominal wounds at the University of Nigeria Teaching Hospital Enugu, Nigeria. Emmanuel R Ezeome, Aloy E Aghaji ...

Comparing systemic therapy and cognitive behavioral therapy for social anxiety disorders: study protocol for a randomized controlled pilot trial.

Science.gov (United States)

Hunger, Christina; Hilzinger, Rebecca; Koch, Theresa; Mander, Johannes; Sander, Anja; Bents, Hinrich; Schweitzer, Jochen

2016-03-31

Social anxiety disorders are among the most prevalent anxiety disorders in the general population. The efficacy of cognitive behavioral therapy (CBT) for social anxiety disorders is well demonstrated. However, only three studies point to the efficacy of systemic therapy (ST) in anxiety disorders, and only two of them especially focus on social anxiety disorders. These ST studies either do not use a good comparator but minimal supportive therapy, they do not use a multi-person ST but a combined therapy, or they do not especially focus on social anxiety disorders but mood and anxiety disorders in general. Though ST was approved as evidence based in Germany for a variety of disorders in 2008, evidence did not include anxiety disorders. This is the first pilot study that will investigate multi-person ST, integrating a broad range of systemic methods, specifically for social anxiety disorders and that will compare ST to the "gold standard" CBT. This article describes the rationale and protocol of a prospective, open, interventive, balanced, bi-centric, pilot randomized controlled trial (RCT). A total of 32 patients with a primary SCID diagnosis of social anxiety disorder will be randomized to either CBT or ST. Both treatments will be manualized. The primary outcome will include social anxiety symptoms at the end of therapy. Therapy will be restricted to no more than 26 hours (primary endpoint). Secondary outcomes will include psychological, social systems and interpersonal functioning, symptom adjustment, and caregiver burden, in addition to change measures, therapist variables and treatment adherence. At the secondary endpoints, 9 and 12 months after the beginning of therapy, we will again assess all outcomes. The study is expected to pilot test a RCT which will be the first to directly compare CBT and multi-person ST, integrating a broad range of systemic methods, for social anxiety disorders, and it will provide empirical evidence for the calculation of the number of

A prospective, randomized, double-blind clinical trial of one nano ...

African Journals Online (AJOL)

Abstract. Background: Recently, manufacturers have introduced bulk‑fill composite resins that reportedly can be placed in increments of 4 mm or greater. Objective: The purpose of this article was to report the results of 12 months prospective randomized clinical trial that evaluated the clinical performance of one ...

Omega-3 Fatty Acids for Depression in Multiple Sclerosis: A Randomized Pilot Study.

Directory of Open Access Journals (Sweden)

Lynne Shinto

Full Text Available Multiple sclerosis is the most common chronic disabling disease in the central nervous system in young to middle aged adults. Depression is common in multiple sclerosis (MS affecting between 50–60% of patients. Pilot studies in unipolar depression report an improvement in depression when omega-3 fatty acids are given with antidepressants. The objective of this study was to investigate whether omega-3 fatty acid supplementation, as an augmentation therapy, improves treatment-resistant major depressive disorder (MDD in people with MS. We performed a randomized, double-blind, placebo-controlled pilot study of omega-3 fatty acids at six grams per day over three months. The primary outcome was a 50% or greater improvement on the Montgomery-Asberg Depression Rating Scale (MADRS. Thirty-nine participants were randomized and thirty-one completed the 3-month intervention. Improvement on MADRS between groups was not significantly different at the 3-month end point with 47.4% in the omega-3 fatty acid group and 45.5% in the placebo group showing 50% or greater improvement (p = 0.30. Omega-3 fatty acids as an augmentation therapy for treatment-resistant depression in MS was not significantly different than placebo in this pilot trial. Omega-3 fatty acid supplementation at the dose given was well-tolerated over 3 months.ClinicalTrials.gov NCT00122954.

Amnioinfusion in very early preterm prelabor rupture of membranes (AMIPROM): pregnancy, neonatal and maternal outcomes in a randomized controlled pilot study.

Science.gov (United States)

Roberts, D; Vause, S; Martin, W; Green, P; Walkinshaw, S; Bricker, L; Beardsmore, C; Shaw, N; McKay, A; Skotny, G; Williamson, P; Alfirevic, Z

2014-05-01

To assess short- and long-term outcomes of pregnant women with very early rupture of membranes randomized to serial amnioinfusion or expectant management, and to collect data to inform a larger, more definitive clinical trial. This was a prospective non-blinded randomized controlled trial with randomization stratified for pregnancies in which the membranes ruptured between 16 + 0 and 19 + 6 weeks' gestation and 20 + 0 and 23 + 6 weeks' gestation to minimize the risk of random imbalance in gestational age distribution between randomized groups. Intention-to-treat analysis was used. The study was conducted in four UK hospital-based fetal medicine units (Liverpool Women's NHS Trust, St Mary's Hospital Manchester, Birmingham Women's NHS Foundation Trust and Wirral University Hospitals Trust). The participants were women with confirmed preterm prelabor rupture of membranes at 16 + 0 to 24 + 0 weeks' gestation. Women with multiple pregnancy, fetal abnormality or obstetric indication for immediate delivery were excluded. Participants were randomly allocated to either serial weekly transabdominal amnioinfusions if the deepest pool of amniotic fluid was amnioinfusion and 28 to expectant management) recruited between 2002 and 2009. There was no significant difference in perinatal mortality (19/28 vs 19/28; relative risk (RR) 1.0 (95% CI, 0.70-1.43)) and maternal or neonatal morbidity. The overall chance of surviving without long-term respiratory or neurodevelopmental disability was 4/56 (7.1%); 4/28 (14.3%) in the amnioinfusion group and 0/28 in the expectant group (RR 9.0 (95% CI, 0.51-159.70)). This pilot study found no major differences in maternal, perinatal or pregnancy outcomes. The study was not designed to show a difference between the groups and the number of survivors was too small to draw any conclusions about long-term outcomes. It does, however, signal that a larger definitive study to evaluate amnioinfusion for improvement in healthy

Recruitment to Online Therapies for Depression: Pilot Cluster Randomized Controlled Trial

OpenAIRE

Jones, Ray B; Goldsmith, Lesley; Hewson, Paul; Williams, Christopher J

2013-01-01

Background Raising awareness of online cognitive behavioral therapy (CBT) could benefit many people with depression, but we do not know how purchasing online advertising compares to placing free links from relevant local websites in increasing uptake. Objective To pilot a cluster randomized controlled trial (RCT) comparing purchase of Google AdWords with placing free website links in raising awareness of online CBT resources for depression in order to better understand research design issues....

The starting dose of levothyroxine in primary hypothyroidism treatment: a prospective, randomized, double-blind trial

NARCIS (Netherlands)

Roos, Annemieke; Linn-Rasker, Suzanne P.; van Domburg, Ron T.; Tijssen, Jan P.; Berghout, Arie

2005-01-01

BACKGROUND: The treatment of hypothyroidism with levothyroxine is effective and simple; however, recommendations for the starting dose vary considerably. To our knowledge, the levothyroxine starting dose has never been studied prospectively. METHODS: We conducted a prospective, randomized,

An internal pilot design for prospective cancer screening trials with unknown disease prevalence.

Science.gov (United States)

Brinton, John T; Ringham, Brandy M; Glueck, Deborah H

2015-10-13

For studies that compare the diagnostic accuracy of two screening tests, the sample size depends on the prevalence of disease in the study population, and on the variance of the outcome. Both parameters may be unknown during the design stage, which makes finding an accurate sample size difficult. To solve this problem, we propose adapting an internal pilot design. In this adapted design, researchers will accrue some percentage of the planned sample size, then estimate both the disease prevalence and the variances of the screening tests. The updated estimates of the disease prevalence and variance are used to conduct a more accurate power and sample size calculation. We demonstrate that in large samples, the adapted internal pilot design produces no Type I inflation. For small samples (N less than 50), we introduce a novel adjustment of the critical value to control the Type I error rate. We apply the method to two proposed prospective cancer screening studies: 1) a small oral cancer screening study in individuals with Fanconi anemia and 2) a large oral cancer screening trial. Conducting an internal pilot study without adjusting the critical value can cause Type I error rate inflation in small samples, but not in large samples. An internal pilot approach usually achieves goal power and, for most studies with sample size greater than 50, requires no Type I error correction. Further, we have provided a flexible and accurate approach to bound Type I error below a goal level for studies with small sample size.

Preoperative therapeutic exercise in frail elderly scheduled for total hip replacement: A randomized pilot trial

NARCIS (Netherlands)

Hoogeboom, T.J.; Dronkers, J.J.; Ende, C.H.M. van den; Oosting, E.; Meeteren, N.L.U. van

2010-01-01

Objective: To evaluate the feasibility and preliminary effectiveness of therapeutic exercise before total hip replacement in frail elderly. Design: A single-blind, randomized clinical pilot trial. Setting: Outpatient physiotherapy department. Subjects: Frail elderly with hip osteoarthritis awaiting

Performance of zirconia ceramic cantilever fixed dental prostheses: 3-year results from a prospective, randomized, controlled pilot study.

Science.gov (United States)

Zenthöfer, Andreas; Ohlmann, Brigitte; Rammelsberg, Peter; Bömicke, Wolfgang

2015-07-01

Little is known about the clinical performance of ceramic cantilever fixed dental prostheses on natural teeth. The purpose of this randomized controlled pilot study was to evaluate the clinical performance of ceramic and metal ceramic cantilever fixed dental prostheses (CFDPs) after 3 years of service. Twenty-one participants were randomly allocated to 2 treatment groups. Participants in the ceramic (ZC) group (n=11) each received 1 CFDP made of yttria-stabilized, tetragonal zirconia polycrystal; the others (n=10) were fitted with a metal ceramic (MC) CFDP. All CFDPs were retained by 2 complete crown abutments and replaced 1 tooth. The clinical target variables were survival, incidence of complications, probing pocket depth (PPD), probing attachment level (PAL), plaque index (PI), gingival index (GI), and esthetic performance as rated by the participants. The United States Public Health Service (USPHS) criteria were used to evaluate chipping, retention, color, marginal integrity, and secondary caries. Descriptive statistics and nonparametric analyses were applied to the target variables in the 2 groups. The esthetic performance of the CFDPs was also visualized by using a pyramid comparison. The overall survival of the CFDPs was 100% in both groups. During the 3-year study, 6 clinically relevant complications requiring aftercare were observed among 5 participants (4 in the ZC group and 2 in the MC group). Changes in the PI, GI, PPD, and PAL of the abutment teeth were similar for both groups (P>.05). The participants regarded the esthetic performance of ZC-CFDPs and MC-CFDPs as satisfactory. Within the 3-year observation period, the clinical performance of MC-FDPs and ZC-FDPs was acceptable. More extensive research with larger sample sizes is encouraged, however, to confirm the evaluation of the survival of Y-TZP hand-veneered cantilever FPDs. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Treating major depression with yoga: A prospective, randomized, controlled pilot trial.

Directory of Open Access Journals (Sweden)

Sudha Prathikanti

Full Text Available Conventional pharmacotherapies and psychotherapies for major depression are associated with limited adherence to care and relatively low remission rates. Yoga may offer an alternative treatment option, but rigorous studies are few. This randomized controlled trial with blinded outcome assessors examined an 8-week hatha yoga intervention as mono-therapy for mild-to-moderate major depression.Investigators recruited 38 adults in San Francisco meeting criteria for major depression of mild-to-moderate severity, per structured psychiatric interview and scores of 14-28 on Beck Depression Inventory-II (BDI. At screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy, herbal or nutraceutical mood therapies, or mind-body practices were excluded. Participants were 68% female, with mean age 43.4 years (SD = 14.8, range = 22-72, and mean BDI score 22.4 (SD = 4.5. Twenty participants were randomized to 90-minute hatha yoga practice groups twice weekly for 8 weeks. Eighteen participants were randomized to 90-minute attention control education groups twice weekly for 8 weeks. Certified yoga instructors delivered both interventions at a university clinic. Primary outcome was depression severity, measured by BDI scores every 2 weeks from baseline to 8 weeks. Secondary outcomes were self-efficacy and self-esteem, measured by scores on the General Self-Efficacy Scale (GSES and Rosenberg Self-Esteem Scale (RSES at baseline and at 8 weeks.In intent-to-treat analysis, yoga participants exhibited significantly greater 8-week decline in BDI scores than controls (p-value = 0.034. In sub-analyses of participants completing final 8-week measures, yoga participants were more likely to achieve remission, defined per final BDI score ≤ 9 (p-value = 0.018. Effect size of yoga in reducing BDI scores was large, per Cohen's d = -0.96 [95%CI, -1.81 to -0.12]. Intervention groups did not differ significantly in 8-week change scores for either the GSES or

Inhaled PGE1 in neonates with hypoxemic respiratory failure: two pilot feasibility randomized clinical trials.

Science.gov (United States)

Sood, Beena G; Keszler, Martin; Garg, Meena; Klein, Jonathan M; Ohls, Robin; Ambalavanan, Namasivayam; Cotten, C Michael; Malian, Monica; Sanchez, Pablo J; Lakshminrusimha, Satyan; Nelin, Leif D; Van Meurs, Krisa P; Bara, Rebecca; Saha, Shampa; Das, Abhik; Wallace, Dennis; Higgins, Rosemary D; Shankaran, Seetha

2014-12-12

Inhaled nitric oxide (INO), a selective pulmonary vasodilator, has revolutionized the treatment of neonatal hypoxemic respiratory failure (NHRF). However, there is lack of sustained improvement in 30 to 46% of infants. Aerosolized prostaglandins I2 (PGI2) and E1 (PGE1) have been reported to be effective selective pulmonary vasodilators. The objective of this study was to evaluate the feasibility of a randomized controlled trial (RCT) of inhaled PGE1 (IPGE1) in NHRF. Two pilot multicenter phase II RCTs are included in this report. In the first pilot, late preterm and term neonates with NHRF, who had an oxygenation index (OI) of ≥15 and <25 on two arterial blood gases and had not previously received INO, were randomly assigned to receive two doses of IPGE1 (300 and 150 ng/kg/min) or placebo. The primary outcome was the enrollment of 50 infants in six to nine months at 10 sites. The first pilot was halted after four months for failure to enroll a single infant. The most common cause for non-enrollment was prior initiation of INO. In a re-designed second pilot, co-administration of IPGE1 and INO was permitted. Infants with suboptimal response to INO received either aerosolized saline or IPGE1 at a low (150 ng/kg/min) or high dose (300 ng/kg/min) for a maximum duration of 72 hours. The primary outcome was the recruitment of an adequate number of patients (n = 50) in a nine-month-period, with fewer than 20% protocol violations. No infants were enrolled in the first pilot. Seven patients were enrolled in the second pilot; three in the control, two in the low-dose IPGE1, and two in the high-dose IPGE1 groups. The study was halted for recruitment futility after approximately six months as enrollment targets were not met. No serious adverse events, one minor protocol deviation and one pharmacy protocol violation were reported. These two pilot RCTs failed to recruit adequate eligible newborns with NHRF. Complex management RCTs of novel therapies for persistent pulmonary

Ultrasonic root-end preparation in apical surgery : a prospective randomized study

NARCIS (Netherlands)

de Lange, Jan; Putters, Thomas; Baas, Erik M.; van Ingen, Johan M.

2007-01-01

Objective. The purpose of this study was to evaluate the potential benefit of an ultrasonic device in apical surgery on the outcome of treatment. Study design. A randomized prospective design was used in a standardized treatment protocol. Patients were allocated to treatment with an ultrasonic

Risk reduction of brain infarction during carotid endarterectomy or stenting using sonolysis - Prospective randomized study pilot data

Science.gov (United States)

Kuliha, Martin; Školoudík, David; Martin Roubec, Martin; Herzig, Roman; Procházka, Václav; Jonszta, Tomáš; Krajča, Jan; Czerný, Dan; Hrbáč, Tomáš; Otáhal, David; Langová, Kateřina

2012-11-01

Sonolysis is a new therapeutic option for the acceleration of arterial recanalization. The aim of this study was to confirm risk reduction of brain infarction during endarterectomy (CEA) and stenting (CAS) of the internal carotid artery (ICA) using sonolysis with continuous transcranial Doppler (TCD) monitoring by diagnostic 2 MHz probe, additional interest was to assess impact of new brain ischemic lesions on cognitive functions. Methods: All consecutive patients 1/ with ICA stenosis >70%, 2/ indicated to CEA or CAS, 3/ with signed informed consent, were enrolled to the prospective study during 17 months. Patients were randomized into 2 groups: Group 1 with sonolysis during intervention and Group 2 without sonolysis. Neurological examination, assessment of cognitive functions and brain magnetic resonance imaging (MRI) were performed before and 24 hours after intervention in all patients. Occurrence of new brain infarctions (including infarctions >0.5 cm3), and the results of Mini-Mental State Examination, Clock Drawing and Verbal Fluency tests were statistically evaluated using T-test. Results: 97 patients were included into the study. Out of the 47 patients randomized to sonolysis group (Group 1) 25 underwent CEA (Group 1a) and 22 CAS (Group 1b). Out of the 50 patients randomized to control group (Group 2), 22 underwent CEA (Group 2a) and 28 CAS (Group 2b). New ischemic brain infarctions on follow up MRI were found in 14 (29.8%) patients in Group 1-4 (16.0%) in Group 1a and 10 (45.5%) in Group 1b. In Group 2, new ischemic brain infarctions were found in 18 (36.0%) patients-6 (27.3%) in Group 2a and 12 (42.9%) in Group 2b (p>0.05 in all cases). New ischemic brain infarctions >0.5 cm3 were found in 4 (8.5 %) patients in Group 1 and in 11 (22.0 %) patients in Group 2 (p= 0.017). No significant differences were found in cognitive tests results between subgroups (p>0.05 in all tests). Conclusion: Sonolysis seems to be effective in the prevention of large ischemic

A prospective study of anxiety in ICD patients with a pilot randomized controlled trial of cognitive behavioral therapy for patients with moderate to severe anxiety

DEFF Research Database (Denmark)

Qintar, Mohammed; George, Jason J; Panko, Melanie

2015-01-01

, but higher anxiety was associated with recent and total number of shocks. The small pilot study suggested that a simple program of CBT might lower moderate-high anxiety with lasting effects to 1 year and supports the need for a larger trial to validate these results. CLINICAL TRIAL REGISTRATION: Clinical......PURPOSE: Stress and anxiety are potential consequences from arrhythmias and implantable cardioverter defibrillator (ICD) shocks that can contribute to substantial morbidity. We assessed anxiety associated with an ICD and whether cognitive behavioral therapy (CBT) reduces anxiety. METHODS: The study...... consisted of two parts: part 1 (N = 690) was a prospective cross-sectional observational study of consecutive ICD patients. Patients completed the Beck Anxiety Inventory (BAI), Generalized Anxiety Disorder Scale (GAD-7), Florida Shock Anxiety Scale (FSAS), and Florida Patient Acceptance Survey (FPAS...

A randomized prospective pilot trial of Web-delivered epilepsy stigma reduction communications in young adults.

Science.gov (United States)

Sajatovic, Martha; Herrmann, Lynn K; Van Doren, Jamie R; Tatsuoka, Curtis; Welter, Elisabeth; Perzynski, Adam T; Bukach, Ashley; Needham, Kelley; Liu, Hongyan; Berg, Anne T

2017-11-01

Epilepsy is a common neurological condition that is often associated with stigmatizing attitudes and negative stereotypes among the general public. This randomized controlled trial (RCT) tested two new communication approaches targeting epilepsy stigma versus an education-alone approach. Two brief stigma-reduction videos were developed, informed by community stakeholder input; one highlighted role competency in people with epilepsy; the other highlighted social inclusion of people with epilepsy. A control video was also developed. A Web-based survey using a prospective RCT design compared effects of experimental videos and control on acceptability, perceived impact, epilepsy knowledge, and epilepsy stigma. Epilepsy knowledge and stigma were measured with the Epilepsy Knowledge Questionnaire (EKQ) and Attitudes and Beliefs about Living with Epilepsy (ABLE), respectively. A total of 295 participants completed the study. Mean age was 23.1 (standard deviation = 3.27) years; 59.0% were male, and 71.4% were white. Overall, respondents felt videos impacted their epilepsy attitudes. EKQ scores were similar across videos, with a trend for higher knowledge in experimental videos versus control (p = 0.06). The role competency and control videos were associated with slightly better perceived impact on attitudes. There were no differences between videos on ABLE scores (p = 0.568). There were subgroup differences suggesting that men, younger individuals, whites, and those with personal epilepsy experience had more stigmatizing attitudes. This RCT tested communication strategies to improve knowledge and attitudes about epilepsy. Although this initial effort will require follow-up, we have demonstrated the acceptability, feasibility, and potential of novel communication strategies to target epilepsy stigma, and a Web-based approach for assessing them. Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.

The Ex-PRESS glaucoma shunt versus trabeculectomy in open-angle glaucoma: a prospective randomized study

NARCIS (Netherlands)

de Jong, Leo A. M. S.

2009-01-01

The purpose of this study was to establish the efficacy and safety of the Ex-PRESS (Optonol Ltd., Neve Ilan, Israel) mini glaucoma shunt in open-angle glaucoma. This was a prospective, randomized trial. Eyes from enrolled patients were randomly assigned to either Ex-PRESS implantation under a

Short-term effects of teriparatide versus placebo on bone biomarkers, structure, and fracture healing in women with lower-extremity stress fractures: A pilot study

Directory of Open Access Journals (Sweden)

Ellen A. Almirol

2016-09-01

Conclusions: In this randomized, pilot study, brief administration of TPTD showed anabolic effects that TPTD may help hasten fracture healing in premenopausal women with lower-extremity stress fractures. Larger prospective studies are warranted to determine the effects of TPTD treatment on stress fracture healing in premenopausal women.

A pilot cluster randomized controlled trial of structured goal-setting following stroke.

Science.gov (United States)

Taylor, William J; Brown, Melanie; William, Levack; McPherson, Kathryn M; Reed, Kirk; Dean, Sarah G; Weatherall, Mark

2012-04-01

To determine the feasibility, the cluster design effect and the variance and minimal clinical importance difference in the primary outcome in a pilot study of a structured approach to goal-setting. A cluster randomized controlled trial. Inpatient rehabilitation facilities. People who were admitted to inpatient rehabilitation following stroke who had sufficient cognition to engage in structured goal-setting and complete the primary outcome measure. Structured goal elicitation using the Canadian Occupational Performance Measure. Quality of life at 12 weeks using the Schedule for Individualised Quality of Life (SEIQOL-DW), Functional Independence Measure, Short Form 36 and Patient Perception of Rehabilitation (measuring satisfaction with rehabilitation). Assessors were blinded to the intervention. Four rehabilitation services and 41 patients were randomized. We found high values of the intraclass correlation for the outcome measures (ranging from 0.03 to 0.40) and high variance of the SEIQOL-DW (SD 19.6) in relation to the minimally importance difference of 2.1, leading to impractically large sample size requirements for a cluster randomized design. A cluster randomized design is not a practical means of avoiding contamination effects in studies of inpatient rehabilitation goal-setting. Other techniques for coping with contamination effects are necessary.

Prospective memory failures in aviation: effects of cue salience, workload, and individual differences.

Science.gov (United States)

Van Benthem, Kathleen D; Herdman, Chris M; Tolton, Rani G; LeFevre, Jo-Anne

2015-04-01

Prospective memory allows people to complete intended tasks in the future. Prospective memory failures, such as pilots forgetting to inform pattern traffic of their locations, can have fatal consequences. The present research examined the impact of system factors (memory cue salience and workload) and individual differences (pilot age, cognitive health, and expertise) on prospective memory for communication tasks in the cockpit. Pilots (N = 101) flew a Cessna 172 simulator at a non-towered aerodrome while maintaining communication with traffic and attending to flight parameters. Memory cue salience (the prominence of cues that signal an intended action) and workload were manipulated. Prospective memory was measured as radio call completion rates. Pilots' prospective memory was adversely affected by low-salience cues and high workload. An interaction of cue salience, pilots' age, and cognitive health reflected the effects of system and individual difference factors on prospective memory failures. For example, younger pilots with low levels of cognitive health completed 78% of the radio calls associated with low-salience memory cues, whereas older pilots with low cognitive health scores completed just 61% of similar radio calls. Our findings suggest that technologies designed to signal intended future tasks should target those tasks with inherently low-salience memory cues. In addition, increasing the salience of memory cues is most likely to benefit pilots with lower levels of cognitive health in high-workload conditions.

PILOT DECONTAMINATION THROUGH PILOT SEQUENCE HOPPING IN MASSIVE MIMO SYSTEMS

DEFF Research Database (Denmark)

2015-01-01

path between one of the users and one of the base stations define one of the channels. The system comprises a pilot generation unit configured to assign pilot sequences randomly among the users and a pilot processing unit configured to filter the pilot sequences received from a user of interest so...... that the channel coefficient of the channel of the user of interest is determined. The pilot sequences received from the user of interest are contaminated by other non-orthogonal or identical pilot sequences from other users of the cell of interest or other cells. The filter is configured so that the contamination...... caused by the other non-orthogonal or identical pilot sequences from the other users is reduced....

Training cognitive flexibility in patients with anorexia nervosa: a pilot randomized controlled trial of cognitive remediation therapy.

Science.gov (United States)

Brockmeyer, Timo; Ingenerf, Katrin; Walther, Stephan; Wild, Beate; Hartmann, Mechthild; Herzog, Wolfgang; Bents, Hinrich; Friederich, Hans-Christoph

2014-01-01

Inefficient cognitive flexibility is considered a neurocognitive trait marker involved in the development and maintenance of anorexia nervosa (AN). Cognitive Remediation Therapy (CRT) is a specific treatment targeting this cognitive style. The aim of this study was to investigate the feasibility and efficacy (by estimating the effect size) of specifically tailored CRT for AN, compared to non-specific cognitive training. A prospective, randomized controlled, superiority pilot trial was conducted. Forty women with AN receiving treatment as usual (TAU) were randomized to receive either CRT or non-specific neurocognitive therapy (NNT) as an add-on. Both conditions comprised 30 sessions of computer-assisted (21 sessions) and face-to-face (9 sessions) training over a 3-week period. CRT focused specifically on cognitive flexibility. NNT was comprised of tasks designed to improve attention and memory. The primary outcome was performance on a neuropsychological post-treatment assessment of cognitive set-shifting. Data available from 25 treatment completers were analyzed. Participants in the CRT condition outperformed participants in the NNT condition in cognitive set-shifting at the end of the treatment (p = 0.027; between-groups effect size d = 0.62). Participants in both conditions showed high treatment acceptance. This study confirms the feasibility of CRT for AN, and provides a first estimate of the effect size that can be achieved using CRT for AN. Furthermore, the present findings corroborate that neurocognitive training for AN should be tailored to the specific cognitive inefficiencies of this patient group. Copyright © 2013 Wiley Periodicals, Inc.

Random forest predictive modeling of mineral prospectivity with small number of prospects and data with missing values in Abra (Philippines)

Science.gov (United States)

Carranza, Emmanuel John M.; Laborte, Alice G.

2015-01-01

Machine learning methods that have been used in data-driven predictive modeling of mineral prospectivity (e.g., artificial neural networks) invariably require large number of training prospect/locations and are unable to handle missing values in certain evidential data. The Random Forests (RF) algorithm, which is a machine learning method, has recently been applied to data-driven predictive mapping of mineral prospectivity, and so it is instructive to further study its efficacy in this particular field. This case study, carried out using data from Abra (Philippines), examines (a) if RF modeling can be used for data-driven modeling of mineral prospectivity in areas with a few (i.e., individual layers of evidential data. Furthermore, RF modeling can handle missing values in evidential data through an RF-based imputation technique whereas in WofE modeling values are simply represented by zero weights. Therefore, the RF algorithm is potentially more useful than existing methods that are currently used for data-driven predictive mapping of mineral prospectivity. In particular, it is not a purely black-box method like artificial neural networks in the context of data-driven predictive modeling of mineral prospectivity. However, further testing of the method in other areas with a few mineral occurrences is needed to fully investigate its usefulness in data-driven predictive modeling of mineral prospectivity.

Effects of Minocycline on Urine Albumin, Interleukin-6, and Osteoprotegerin in Patients with Diabetic Nephropathy: A Randomized Controlled Pilot Trial

Science.gov (United States)

Wang, Ying; Tong, Lili; Pak, Youngju; Andalibi, Ali; LaPage, Janine A.; Adler, Sharon G.

2016-01-01

Background We tested minocycline as an anti-proteinuric adjunct to renin-angiotensin-aldosterone system inhibitors (RAASi) in diabetic nephropathy (DN) and measured urinary biomarkers to evaluate minocycline’s biological effects. Methods Design: Prospective, single center, randomized, placebo-controlled, intention-to-treat pilot trial. Inclusion. Type 2 diabetes/DN; Baseline creatinine clearance > 30 mL/min; proteinuria ≥ 1.0 g/day; Age ≥30 years; BP minocycline patients (6 month P:Cr ÷ Baseline P:Cr, 0.85 vs. 0.92) was not significant (p = 0.27). Creatinine clearance did not differ in the 2 groups. Urine IL-6:Cr (p = 0.03) and osteoprotegerin/Cr (p = 0.046) decrements were significant. Minocycline modified the relationship between urine IL-6 and proteinuria, suggesting a protective biological effect. Conclusions Although the decline in U P:Cr in minocycline patients was not statistically significant, the significant differences in urine IL-6 and osteoprotegerin suggest that minocycline may confer cytoprotection in patients with DN, providing a rationale for further study. Trial Registration Clinicaltrials.gov NCT01779089 PMID:27019421

Sodium bicarbonate on severe metabolic acidosis during prolonged cardiopulmonary resuscitation: a double-blind, randomized, placebo-controlled pilot study.

Science.gov (United States)

Ahn, Shin; Kim, Youn-Jung; Sohn, Chang Hwan; Seo, Dong Woo; Lim, Kyoung Soo; Donnino, Michael W; Kim, Won Young

2018-04-01

Sodium bicarbonate administration during cardiopulmonary resuscitation (CPR) is controversial. Current guidelines recommend sodium bicarbonate injection in patients with existing metabolic acidosis, but clinical trials, particularly, those involving patients with acidosis, are limited. We aimed to evaluate the efficacy of sodium bicarbonate administration in out-of-hospital cardiac arrest (OHCA) patients with severe metabolic acidosis during prolonged CPR. Prospective, double-blind, randomized placebo-controlled pilot trial was conducted between January 2015 and December 2015, at a single center emergency department (ED). After 10 minutes of CPR, patients who failed to achieve return of spontaneous circulation (ROSC) and with severe metabolic acidosis (pH<7.1 or bicarbonate <10 mEq/L) were enrolled. Sodium bicarbonate (n=25) or normal saline (n=25) were administered. The primary end point was sustained ROSC. The secondary end points were the change of acidosis and good neurologic survival. Sodium bicarbonate group had significant effect on pH (6.99 vs. 6.90, P=0.038) and bicarbonate levels (21.0 vs. 8.0 mEq/L, P=0.007). However, no significant differences showed between sodium bicarbonate and placebo groups in sustained ROSC (4.0% vs. 16.0%, P=0.349) or good neurologic survival at 1 month (0.0% vs. 4.0%, P=1.000). The use of sodium bicarbonate improved acid-base status, but did not improve the rate of ROSC and good neurologic survival. We could not draw a conclusion, but our pilot data could be used to design a larger trial to verify the efficacy of sodium bicarbonate. NCT02303548 (http://www.ClinicalTrials.gov).

Emotion Regulation Enhancement of Cognitive Behavior Therapy for College Student Problem Drinkers: A Pilot Randomized Controlled Trial

Science.gov (United States)

Ford, Julian D.; Grasso, Damion J.; Levine, Joan; Tennen, Howard

2018-01-01

This pilot randomized clinical trial tested an emotion regulation enhancement to cognitive behavior therapy (CBT) with 29 college student problem drinkers with histories of complex trauma and current clinically significant traumatic stress symptoms. Participants received eight face-to-face sessions of manualized Internet-supported CBT for problem…

Successful Completion of the Pilot Phase of a Randomized Controlled Trial Comparing Sentinel Lymph Node Biopsy to No Further Axillary Staging in Patients with Clinical T1-T2 N0 Breast Cancer and Normal Axillary Ultrasound.

Science.gov (United States)

Cyr, Amy E; Tucker, Natalia; Ademuyiwa, Foluso; Margenthaler, Julie A; Aft, Rebecca L; Eberlein, Timothy J; Appleton, Catherine M; Zoberi, Imran; Thomas, Maria A; Gao, Feng; Gillanders, William E

2016-08-01

Axillary surgery is not considered therapeutic in patients with clinical T1-T2 N0 breast cancer. The importance of axillary staging is eroding in an era in which tumor biology, as defined by biomarker and gene expression profile, is increasingly important in medical decision making. We hypothesized that axillary ultrasound (AUS) is a noninvasive alternative to sentinel lymph node biopsy (SLNB), and AUS could replace SLNB without compromising patient care. Patients with clinical T1-T2 N0 breast cancer and normal AUS were eligible for enrollment. Subjects were randomized to no further axillary staging (arm 1) vs SLNB (arm 2). Descriptive statistics were used to describe the results of the pilot phase of the randomized controlled trial. Sixty-eight subjects were enrolled in the pilot phase of the trial (34 subjects in arm 1, no further staging; 32 subjects in arm 2, SLNB; and 2 subjects voluntarily withdrew from the trial). The median age was 61 years (range 40 to 80 years) in arm 1 and 59 years (range 31 to 81 years) in arm 2, and there were no significant clinical or pathologic differences between the arms. Median follow-up was 17 months (range 1 to 32 months). The negative predictive value (NPV) of AUS for identification of clinically significant axillary disease (>2.0 mm) was 96.9%. No axillary recurrences have been observed in either arm. Successful completion of the pilot phase of the randomized controlled trial confirms the feasibility of the study design, and provides prospective evidence supporting the ability of AUS to exclude clinically significant disease in the axilla. The results provide strong support for a phase 2 randomized controlled trial. Copyright © 2016 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Effect of Playful Balancing Training - A Pilot Randomized Controlled Trial

DEFF Research Database (Denmark)

Lund, Henrik Hautop; Jessen, Jari Due

2013-01-01

We used the modular playware in the form of modular interactive tiles for playful training of community-dwelling elderly with balancing problem. During short-term play on the modular interactive tiles, the elderly were playing physical, interactive games that were challenging their dynamic balance...... increase in balancing performance (DGI score: 21.3) after short-term playful training with the modular interactive tiles, whereas the control group remained with a score indicating balancing problems and risk of falling (DGI score: 16.6). The small pilot randomized controlled trial suggests...... that the playful interaction with the modular interactive tiles has a significant effect even after a very short time of play. The average total training time to obtain the statistical significant effect amounted to just 2h45m....

Varenicline for opioid withdrawal in patients with chronic pain: a randomized, single-blinded, placebo controlled pilot trial.

Science.gov (United States)

Hooten, W Michael; Warner, David O

2015-03-01

The objectives of this randomized, single-blinded, placebo-controlled pilot trial were to investigate the effects of varenicline on opioid withdrawal among chronic pain patients undergoing opioid detoxification in an interdisciplinary pain program and the feasibility of varenicline use in this population. Twenty-one patients were recruited (varenicline=10, placebo=11), and 7 patients in the varenicline and 11 in the placebo group completed the study. Opioid withdrawal was quantified using the Clinical Opiate Withdrawal Scale, and varenicline-related adverse effects were assessed. Opioid withdrawal scores tended to decrease over the course of opioid tapering in those receiving varenicline and increase in those receiving placebo. Varenicline was well-tolerated in this population, with no adverse drug effects (including nausea) observed and no effect on improvements in pain severity and depression. This randomized pilot study provides preliminary data for future trials of varenicline in opioid-dependent adults with chronic pain undergoing medically directed opioid detoxification. Copyright © 2014 Elsevier Ltd. All rights reserved.

Stress Management-Augmented Behavioral Weight Loss Intervention for African American Women: A Pilot, Randomized Controlled Trial

Science.gov (United States)

Cox, Tiffany L.; Krukowski, Rebecca; Love, ShaRhonda J.; Eddings, Kenya; DiCarlo, Marisha; Chang, Jason Y.; Prewitt, T. Elaine; West, Delia Smith

2013-01-01

The relationship between chronic stress and weight management efforts may be a concern for African American (AA) women, who have a high prevalence of obesity, high stress levels, and modest response to obesity treatment. This pilot study randomly assigned 44 overweight/obese AA women with moderate to high stress levels to either a 12-week…

A prospective, randomized, single - blind study comparing intraplaque injection of thiocolchicine and verapamil in Peyronie's Disease: a pilot study

Directory of Open Access Journals (Sweden)

I. L. Toscano Jr.

Full Text Available ABSTRACT Objectives: To compare the response to tiocolchicine and verapamil injection in the plaque of patients with Peyronie's disease. Materials and Methods: Prospective, single-blind, randomized study, selecting patients who have presented Peyronie's disease for less than 18 months. Thiocolchicine 4mg or verapamil 5mg were given in 7 injections (once a week. Patients who had received any treatment for Peyronie's disease in the past three months were excluded. The parameters used were the International Index of Erectile Function (IIEF-5 score, analysis of the curvature on pharmaco-induced erections and size of the plaque by ultrasonography. Results: Twenty-five patients were randomized, 13 received thiocolchicine and 12 were treated with verapamil. Both groups were statistically similar. The mean curvature was 46.7° and 36.2° before and after thiocolchicine, respectively (p=0.019 and 50.4° and 42.08° before and after verapamil, respectively (p=0.012. The curvature improved in 69% of patients treated with thiocolchicine and in 66% of those who received verapamil. Regarding sexual function, there was an increase in the IIEF-5 from 16.69 to 20.85 (p=0.23 in the thiocolchicine group. In the verapamil group the IIEF-5 score dropped from 17.50 to 16.25 (p=0.58. In the thiocolchicine group, the plaque was reduced in 61% of patients. In the verapamil group, 8% presented decreased plaque size. No adverse event was associated to thiocolchicine. Conclusion: The use of thiocolchicine in Peyronie's disease demonstrated improvement on penile curvature and reduction in plaque size. Thiocolchicine presented similar results to verapamil in curvature assessment. No significant side effects were observed with the use of tiocolchicine.

A Pilot Randomized Controlled Trial of a Guided Self-Help Intervention to Manage Chronic Orofacial Pain.

Science.gov (United States)

Goldthorpe, Joanna; Lovell, Karina; Peters, Sarah; McGowan, Linda; Nemeth, Imola; Roberts, Christopher; Aggarwal, Vishal R

2017-01-01

To conduct a pilot trial to test the feasibility of a guided self-help intervention for chronic orofacial pain. A pilot randomized controlled trial was conducted to compare the intervention with usual treatment. A total of 37 patients with chronic orofacial pain were randomized into either the intervention group (n = 19) or the usual treatment (control) group (n = 18). Validated outcome measures were used to measure the potential effectiveness of the intervention over a number of domains: physical and mental functioning (Short Form 36 [SF-36]); anxiety and depression (Hospital Anxiety and Depression Scale [HADS]); pain intensity and interference with life (Brief Pain Inventory [BPI]); disability (Manchester Orofacial Pain Disability Scale [MOPDS]); and illness behavior (Revised Illness Perceptions Questionnaire [IPQr]). Bootstrap confidence intervals were computed for the treatment effect (ES) posttreatment and at 3 months follow-up and adjusted for baseline values of the outcome measure by using analysis of covariance. At posttreatment and the 3-month follow-up, 11 participants in the intervention group and 7 in the control group failed to complete outcome measures. The intervention was acceptable and could be feasibly delivered face to face or over the telephone. Although the pilot trial was not powered to draw conclusions about the effectiveness, it showed significant (P orofacial pain. It showed potential effectiveness on outcome domains related to functioning and illness perception. Further research is needed to understand the cost effectiveness of the intervention for chronic orofacial pain.

Quality of Life and Neutropenia in Patients with Early Stage Breast Cancer: A Randomized Pilot Study Comparing Additional Treatment with Mistletoe Extract to Chemotherapy Alone

Directory of Open Access Journals (Sweden)

Wilfried Tröger

2009-01-01

Full Text Available Background: Chemotherapy for breast cancer often deteriorates quality of life, augments fatigue, and induces neutropenia. Mistletoe preparations are frequently used by cancer patients in Central Europe. Physicians have reported better quality of life in breast cancer patients additionally treated with mistletoe preparations during chemotherapy. Mistletoe preparations also have immunostimulant properties and might therefore have protective effects against chemotherapy-induced neutropenia.Patients and Methods: We conducted a prospective randomized open label pilot study with 95 patients randomized into three groups. Two groups received Iscador® M special (IMS or a different mistletoe preparation, respectively, additionally to chemotherapy with six cycles of cyclophosphamide, adriamycin, and 5-fluoro-uracil (CAF. A control group received CAF with no additional therapy. Here we report the comparison IMS (n = 30 vs. control (n = 31. Quality of life including fatigue was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30. Neutropenia was defined as neutrophil counts <1,000/µl and assessed at baseline and one day before each CAF cycle.Results: In the descriptive analysis all 15 scores of the EORTC-QLQ-C30 showed better quality of life in the IMS group compared to the control group. In 12 scores the differences were significant (p < 0.02 and nine scores showed a clinically relevant and significant difference of at least 5 points. Neutropenia occurred in 3/30 IMS patients and in 8/31 control patients (p = 0.182.Conclusions: This pilot study showed an improvement of quality of life by treating breast cancer patients with IMS additionally to CAF. CAF-induced neutropenia showed a trend to lower frequency in the IMS group.

Adhesive strip wound closure after thyroidectomy/parathyroidectomy: a prospective, randomized controlled trial.

LENUS (Irish Health Repository)

O'Leary, D Peter

2013-03-01

Conventional collar incision closure in thyroid and parathyroid surgery involves the insertion of an epidermal layer of subcutaneous absorbable sutures that are reinforced by a deep layer of sutures. Adhesive strips offer an alternative method to close the epidermal layer. The aim of this study was to compare adhesive strip closure with absorbable sutures for collar incisions in a prospective, single-blinded, randomized controlled trial.

Double-blind, randomized, controlled, pilot study comparing classic ayurvedic medicine, methotrexate, and their combination in rheumatoid arthritis.

Science.gov (United States)

Furst, Daniel E; Venkatraman, Manorama M; McGann, Mary; Manohar, P Ram; Booth-LaForce, Cathryn; Sarin, Reshmi; Sekar, P G; Raveendran, K G; Mahapatra, Anita; Gopinath, Jidesh; Kumar, P R Krishna

2011-06-01

To compare classic Ayurveda, methotrexate (MTX), and their combination in a double-blind, randomized, double-dummy, pilot trial in rheumatoid arthritis (RA) for 36 weeks. Forty-three seropositive RA patients by American College of Rheumatology (ACR) criteria with disease duration of less than 7 years were assigned to the following treatment groups: MTX plus Ayurvedic placebo (n = 14), Ayurveda plus MTX placebo (n = 12), or Ayurveda plus MTX (n = 17). Outcomes included the Disease Activity Score (DAS28-CRP), ACR20/50/70, and Health Assessment Questionnaire--Disability Index. All measures were obtained every 12 weeks for 36 weeks. Analyses included descriptive statistics, analysis of variance, χ², or Student t test. The unique features of this study included the development of placebos for each Ayurvedic pharmacological dosage form and individualization of Ayurvedic therapy. All groups were comparable at baseline in demographics and disease characteristics. There were no statistically significant differences among the 3 groups on the efficacy measures. ACR20 results were MTX 86%, Ayurveda 100%, and combination 82%, and DAS28-CRP response were MTX -2.4, Ayurveda -1.7, and combination -2.4. Differences in adverse events among groups were also not statistically significant, although the MTX groups experienced more adverse event (MTX 174, Ayurveda 112, combination 176). No deaths occurred. In this first-ever, double-blind, randomized, placebo-controlled pilot study comparing Ayurveda, MTX, and their combination, all 3 treatments were approximately equivalent in efficacy, within the limits of a pilot study. Adverse events were numerically fewer in the Ayurveda-only group. This study demonstrates that double-blind, placebo-controlled, randomized studies are possible when testing individualized classic Ayurvedic versus allopathic treatment in ways acceptable to western standards and to Ayurvedic physicians. It also justifies the need for larger studies.

One-day versus 3-day suprapubic catheterization after vaginal prolapse surgery : a prospective randomized trial

NARCIS (Netherlands)

Van der Steen, Annemarie; Detollenaere, Renee; Den Boon, Jan; Van Eijndhoven, Hugo

For prolonged catheterization after vaginal prolapse surgery with anterior colporrhaphy, the optimal duration to prevent overdistention of the bladder remains unknown. We designed this study to determine the optimal length of catheterization. We conducted a prospective randomized trial in which 179

Computer-Based Cognitive Training for Mild Cognitive Impairment: Results from a Pilot Randomized, Controlled Trial

OpenAIRE

Barnes, Deborah E.; Yaffe, Kristine; Belfor, Nataliya; Jagust, William J.; DeCarli, Charles; Reed, Bruce R.; Kramer, Joel H.

2009-01-01

We performed a pilot randomized, controlled trial of intensive, computer-based cognitive training in 47 subjects with mild cognitive impairment (MCI). The intervention group performed exercises specifically designed to improve auditory processing speed and accuracy for 100 minutes/day, 5 days/week for 6 weeks; the control group performed more passive computer activities (reading, listening, visuospatial game) for similar amounts of time. Subjects had a mean age of 74 years and 60% were men; 7...

The Coping Cat Program for Children with Anxiety and Autism Spectrum Disorder: A Pilot Randomized Controlled Trial

Science.gov (United States)

McNally Keehn, Rebecca H.; Lincoln, Alan J.; Brown, Milton Z.; Chavira, Denise A.

2013-01-01

The purpose of this pilot study was to evaluate whether a modified version of the Coping Cat program could be effective in reducing anxiety in children with autism spectrum disorder (ASD). Twenty-two children (ages 8-14; IQ greater than or equal to 70) with ASD and clinically significant anxiety were randomly assigned to 16 sessions of the Coping…

Immunophenotyping and efficacy of low dose ATG in non-sensitized kidney recipients undergoing early steroid withdrawal: a randomized pilot study.

Directory of Open Access Journals (Sweden)

Monica Grafals

Full Text Available Rabbit antithymocyte globulin (ATG is commonly used as an induction therapy in renal transplant recipients, but the ideal dosage in tacrolimus-based early steroid withdrawal protocols has not been established. The purpose of this pilot study was to determine the immunophenotyping and efficacy of lower dose ATG in low immunological-risk kidney transplant recipients. In this prospective study, 45 patients were randomized (1∶1 to our standard dose ATG (total dose 3.75 mg/kg(sATG vs. lower dose 2.25 mg/kg (lowATG. All patients underwent early steroid withdrawal within 7 days. The primary end point was biopsy-proven acute rejection at 12 months. Prospective immunophenotyping of freshly isolated PBMCs was performed at baseline, 3, 6, 12 months post-transplant. The rate of acute rejection was 17% and 10% in the sATG and lowATG, respectively. Effector memory T cells, Tregs and recent thymic emigrants T cells had similar kinetics post-transplant in both groups. No statistically significant differences were found in graft survival, patient survival or infections between the two groups, though there was a non-significant increase in leukopenia (43%v s. 30%, CMV (8% vs. 0 and BK (4% vs. 0 infections in sATG group vs. lowATG. In sum, in low immunological risk kidney recipients undergoing steroid withdrawal, low dose ATG seems to be efficacious in preventing acute rejection and depleting T cells with potentially lower infectious complications. A larger study is warranted to confirm these findings.ClinicalTrials.gov NCT00548405.

Gaming and Conventional Exercises for Improvement of Arm Function After Stroke: A Randomized Controlled Pilot Study.

Science.gov (United States)

Kottink, Anke I R; Prange, Gerdienke B; Krabben, Thijs; Rietman, Johan S; Buurke, Jaap H

2014-06-01

The use of new technologies in rehabilitation, such as virtual reality and/or computerized gaming exercises, may be useful to enable patients to practice intensively in a motivating way. The objective of the present randomized controlled pilot study was to compare the effect of reach training using a target group specific-designed rehabilitation game to time-matched standardized conventional reach training on arm function after stroke. Twenty chronic stroke patients were randomized to either the rehabilitation game group or the conventional training group. Both groups received three arm training sessions of 30 minutes each week, during a period of 6 weeks. Arm (the upper extremity part of Fugl-Meyer [FM] assessment) and hand (the Action Research Arm [ARA] test) functions were tested 1 week before (T0) and 1 week after (T1) training. A follow-up measurement was performed at 1 month after T1 (T2). ARA and FM scores improved significantly within both groups. Post hoc comparisons revealed significant increases in test scores between T0 and T1 and between T0 and T2 for both ARA and FM, but not for changes from T1 to T2. There were no significant differences between both groups for either clinical test. The present randomized controlled pilot study showed that both arm and hand function improved as much after training with a rehabilitation game as after time-matched conventional training.

A pilot randomized control trial investigating the effect of mindfulness practice on pain tolerance, psychological well-being, and physiological activity

DEFF Research Database (Denmark)

Kingston, Jessica; Chadwick, Paul; Meron, Daniel

2007-01-01

Objective: To investigate the effect of mindfulness training on pain tolerance, psychological well-being, physiological activity, and the acquisition of mindfulness skills. Methods: Forty-two asymptomatic University students participated in a randomized, single-blind, active control pilot study. ...

Feasibility of a Preventive Parenting Intervention for Very Preterm Children at 18 Months Corrected Age: A Randomized Pilot Trial

NARCIS (Netherlands)

Flierman, Monique; Koldewijn, Karen; Meijssen, Dominique; van Wassenaer-Leemhuis, Aleid; Aarnoudse-Moens, Cornelieke; van Schie, Petra; Jeukens-Visser, Martine

2016-01-01

To evaluate the feasibility and potential efficacy of an age-appropriate additional parenting intervention for very preterm born toddlers. In a randomized controlled pilot study, 60 of 94 eligible very preterm born children who had received a responsive parenting intervention in their first year

Meal-Replacements followed by Topiramate for the Treatment of Adolescent Severe Obesity: A Pilot Randomized Controlled Trial

Science.gov (United States)

Fox, Claudia K.; Kaizer, Alexander M.; Rudser, Kyle D.; Nathan, Brandon M.; Gross, Amy C.; Sunni, Muna; Abuzzahab, M. Jennifer; Schwartz, Betsy L.; Kumar, Seema; Petryk, Anna; Billington, Charles J.; Ryder, Justin R.; Kelly, Aaron S.

2016-01-01

Objective The objective of this pilot study was to assess the safety and efficacy of short-term meal replacement therapy followed by topiramate for body mass index (BMI) reduction in adolescents with severe obesity. Methods Adolescents (ages 12-18 years) with severe obesity (BMI ≥1.2 times the 95th percentile or BMI ≥35 kg/m2) were recruited for this double-blind, randomized, placebo-controlled trial. Participants completed 4 weeks of meal replacement therapy followed by randomization (1:1) to either 24 weeks of topiramate 75 mg/day or placebo. Mean changes were compared between groups. Results Thirty adolescents (mean age 15.2 ± 1.7 years, mean BMI 40.3 ± 4.6 kg/m2) completed the meal replacement phase and were randomized; 21 completed the study. The difference in mean percent change in BMI between the topiramate and placebo groups was not significant (−1.9% [95% CI (−5.2%, +1.5%); P=0.291]). Significant improvements in visceral fat and VLDL-c were observed in the topiramate compared to the placebo group. There were no concerning changes in neurocognitive function or bone health. Conclusion In this pilot study, 4 weeks of meal replacement therapy followed by 24 weeks of low-dose topiramate compared to meal replacement therapy alone did not result in significant BMI reduction for adolescents with severe obesity. PMID:27807925

Running injuries in novice runners enrolled in different training interventions: a pilot randomized controlled trial.

Science.gov (United States)

Baltich, J; Emery, C A; Whittaker, J L; Nigg, B M

2017-11-01

The purpose of this trial was to evaluate injury risk in novice runners participating in different strength training interventions. This was a pilot randomized controlled trial. Novice runners (n = 129, 18-60 years old, running experience) were block randomized to one of three groups: a "resistance" strength training group, a "functional" strength training group, or a stretching "control" group. The primary outcome was running related injury. The number of participants with complaints and the injury rate (IR = no. injuries/1000 running hours) were quantified for each intervention group. For the first 8 weeks, participants were instructed to complete their training intervention three to five times a week. The remaining 4 months was a maintenance period. NCT01900262. A total of 52 of the 129 (40%) novice runners experienced at least one running related injury: 21 in the functional strength training program, 16 in the resistance strength training program and 15 in the control stretching program. Injury rates did not differ between study groups [IR = 32.9 (95% CI 20.8, 49.3) in the functional group, IR = 31.6 (95% CI 18.4, 50.5) in the resistance group, and IR = 26.7 (95% CI 15.2, 43.2)] in the control group. Although this was a pilot assessment, home-based strength training did not appear to alter injury rates compared to stretching. Future studies should consider methods to minimize participant drop out to allow for the assessment of injury risk. Injury risk in novice runners based on this pilot study will inform the development of future larger studies investigating the impact of injury prevention interventions. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Pilot randomized controlled trial of dialectical behavior therapy group skills training for ADHD among college students.

Science.gov (United States)

Fleming, Andrew P; McMahon, Robert J; Moran, Lyndsey R; Peterson, A Paige; Dreessen, Anthony

2015-03-01

ADHD affects between 2% and 8% of college students and is associated with broad functional impairment. No prior randomized controlled trials with this population have been published. The present study is a pilot randomized controlled trial evaluating dialectical behavior therapy (DBT) group skills training adapted for college students with ADHD. Thirty-three undergraduates with ADHD between ages 18 and 24 were randomized to receive either DBT group skills training or skills handouts during an 8-week intervention phase. ADHD symptoms, executive functioning (EF), and related outcomes were assessed at baseline, post-treatment, and 3-month follow-up. Participants receiving DBT group skills training showed greater treatment response rates (59-65% vs. 19-25%) and clinical recovery rates (53-59% vs. 6-13%) on ADHD symptoms and EF, and greater improvements in quality of life. DBT group skills training may be efficacious, acceptable, and feasible for treating ADHD among college students. A larger randomized trial is needed for further evaluation. © 2014 SAGE Publications.

Randomized Controlled Trial for Early Intervention for Autism: A Pilot Study of the Autism 1-2-3 Project

Science.gov (United States)

Wong, Virginia C. N.; Kwan, Queenie K.

2010-01-01

We piloted a 2-week "Autism-1-2-3" early intervention for children with autism and their parents immediately after diagnosis that targeted at (1) eye contact, (2) gesture and (3) vocalization/words. Seventeen children were randomized into the Intervention (n = 9) and Control (n = 8) groups. Outcome measures included the Autism Diagnostic…

Laparoscopic Surgical Treatment of Severe Obesity Combined with Gastroesophageal Reflux Disease: A Pilot Randomized Two-Arm Controlled Clinical Study

Science.gov (United States)

Ospanov, Oral B.; Orekeshova, Akzhunis M.; Fursov, Roman A.; Yelemesov, Aset A.

2016-01-01

Obesity and gastroesophageal reflux disease (GERD) are serious medical, social, and economic problems of modern society. A pilot randomized two-arm controlled clinical study was conducted to compare laparoscopic plication of the greater gastric curvature combined with Nissen fundoplication (LFN+LGP) versus only Nissen fundoplication (LFN). The…

Effects of errorless skill learning in people with mild-to-moderate or severe dementia: a randomized controlled pilot study.

NARCIS (Netherlands)

Kessels, R.P.C.; Hensken, L.M.

2009-01-01

This pilot study examines whether learning without errors is advantageous compared to trial-and-error learning in people with dementia using a procedural task and a randomized case-control design. A sample of 60 people was recruited, consisting of 20 patients with severe dementia, 20 patients with

Effects of errorless skill learning in people with mild-to-moderate or severe dementia: A randomized controlled pilot study

NARCIS (Netherlands)

Kessels, R.P.C.; Olde Hensken, L.M.G.

2009-01-01

This pilot study examines whether learning without errors is advantageous compared to trial-and-error learning in people with dementia using a procedural task and a randomized case-control design. A sample of 60 people was recruited, consisting of 20 patients with severe dementia, 20 patients with

Intrapartum amnioinfusion in women with oligohydramniosis. A prospective randomized trial.

Science.gov (United States)

Persson-Kjerstadius, N; Forsgren, H; Westgren, M

1999-02-01

To evaluate the effects of amnioinfusion in oligohydramniosis. During a 20-month period, patients at term with oligohydramniosis (amniotic fluid index less than 5 cm) at Huddinge University and Norrköping Hospitals were recruited for a prospective randomized study to evaluate amnioinfusion. Informed consent was obtained from 112 patients who met the entry criteria. Sixty subjects were randomized to amnioinfusion and 52 to the control group. Outcome parameters included fetal heart rate abnormalities, mode of delivery, Apgar score, pH in umbilical artery blood and need for neonatal intensive care. The cesarean section rate was significantly reduced in the amnio-infusion group (29% versus 13%, p=0.043). No difference in time from randomization to delivery was detected between the two groups. The frequency of ominous fetal heart rate tracings with a cervical dilatation of 0-3 cm was the same in the two groups. The frequency of such heart rate patterns after amnioinfusion was significantly lower than in the control group. Neonatal outcome, pH in the umbilical artery blood and need for neonatal intensive care did not differ between the two groups. The present study confirms the findings of other authors that amnioinfusion effectively reduces the number of cesarean sections in cases of oligohydramniosis.

Nonoperative Treatment of Thoracic and Lumbar Spine Fractures : A Prospective Randomized Study of Different Treatment Options

NARCIS (Netherlands)

Stadhouder, Agnita; Buskens, Erik; Vergroesen, Diederik A.; Fidler, Malcolm W.; de Nies, Frank; Oner, F. C.

Objectives: To evaluate and compare nonoperative treatment methods for traumatic thoracic and lumbar compression fractures and burst fractures. Design: Prospective randomized controlled trial with long-term follow-up. Setting: Two general hospitals in the Netherlands. Patients/Participants: Patients

Membrane versus centrifuge-based therapeutic plasma exchange: a randomized prospective crossover study.

Science.gov (United States)

Hafer, Carsten; Golla, Paulina; Gericke, Marion; Eden, Gabriele; Beutel, Gernot; Schmidt, Julius J; Schmidt, Bernhard M W; De Reys, Stef; Kielstein, Jan T

2016-01-01

Therapeutic plasma exchange (TPE) is either performed using a highly permeable filter with standard multifunctional renal replacement equipment (mTPE) or a centrifugation device (cTPE). Although both techniques are well established in clinical practice, performance of these two modes of TPE was never compared in a prospective randomized fashion. Thus we aimed to compare two commercially available therapeutic apheresis systems: mTPE (Octonova with Plasmaflo filter) and cTPE (Spectra Optia apheresis system). Twenty-one patients (age 51.6 ± 13.5 years; 10 F/11 M; BMI 25.1 ± 5.0 kg/m(2)) were enrolled in this randomized, prospective, paired, crossover study performed in the Hannover Medical School, Germany. First treatment (either mTPE or cTPE) was chosen by an online randomization list. The primary endpoints were plasma removal efficiency with 1.2× of the total plasma volume exchanged. Secondary endpoints were total amount of plasma substances removed, such as IgG and fibrinogen. Further, the treatment effect on platelet count and complications were evaluated. Despite a comparable volume of the processed plasma, mTPE treatment time was 10.5 % longer than cTPE treatment time (p centrifugal procedures were conducted using flow rates that could easily be obtained using peripheral access, plasma removal efficiency was significantly higher and treatment time was significantly lower in cTPE as compared to mTPE. Despite this lower treatment time, the decline in markers of procedure efficacy was comparable. Especially in centers performing many procedures per year, cTPE in contrast to mTPE can reduce treatment time without compromising treatment efficacy.

Individual cognitive behavioral therapy for insomnia in breast cancer survivors: a randomized controlled crossover pilot study

Science.gov (United States)

Fiorentino, Lavinia; McQuaid, John R; Liu, Lianqi; Natarajan, Loki; He, Feng; Cornejo, Monique; Lawton, Susan; Parker, Barbara A; Sadler, Georgia R; Ancoli-Israel, Sonia

2010-01-01

Purpose Estimates of insomnia in breast cancer patients are high, with reports of poor sleep lasting years after completion of cancer treatment. This randomized controlled crossover pilot study looked at the effects of individual cognitive behavioral therapy for insomnia (IND-CBT-I) on sleep in breast cancer survivors. Patients and methods Twenty-one participants were randomly assigned to either a treatment group (six weekly IND-CBT-I sessions followed by six weeks of follow up) or a delayed treatment control group (no treatment for six weeks followed by six weekly IND-CBT-I sessions). Of these, 14 participants completed the pilot study (six in the treatment group and eight in the delayed treatment control group). Results Self-rated insomnia was significantly improved in the treatment group compared to the waiting period in the delayed treatment control group. The pooled pre-post-IND-CBT-I analyses revealed improvements in self-rated insomnia, sleep quality, and objective measures of sleep. Conclusions These preliminary results suggest that IND-CBT-I is appropriate for improving sleep in breast cancer survivors. Individual therapy in a clinic or private practice may be a more practical option for this population as it is more easily accessed and readily available in an outpatient setting. PMID:23616695

Restrictive versus liberal transfusion strategies for older mechanically ventilated critically ill patients: a randomized pilot trial.

Science.gov (United States)

Walsh, Timothy S; Boyd, Julia A; Watson, Douglas; Hope, David; Lewis, Steff; Krishan, Ashma; Forbes, John F; Ramsay, Pamela; Pearse, Rupert; Wallis, Charles; Cairns, Christopher; Cole, Stephen; Wyncoll, Duncan

2013-10-01

To compare hemoglobin concentration (Hb), RBC use, and patient outcomes when restrictive or liberal blood transfusion strategies are used to treat anemic (Hb≤90 g/L) critically ill patients of age≥55 years requiring≥4 days of mechanical ventilation in ICU. Parallel-group randomized multicenter pilot trial. Six ICUs in the United Kingdom participated between August 2009 and December 2010. One hundred patients (51 restrictive and 49 liberal groups). Patients were randomized to a restrictive (Hb trigger, 70 g/L; target, 71-90 g/L) or liberal (90 g/L; target, 91-110 g/L) transfusion strategy for 14 days or the remainder of ICU stay, whichever was longest. Baseline comorbidity rates and illness severity were high, notably for ischemic heart disease (32%). The Hb difference among groups was 13.8 g/L (95% CI, 11.5-16.0 g/L); pdisease, Acute Physiology and Chronic Health Evaluation II score, and total non-neurologic Sequential Organ Failure Assessment score at baseline (hazard ratio, 0.54 [95% CI, 0.28-1.03]; p=0.061). A large trial of transfusion strategies in older mechanically ventilated patients is feasible. This pilot trial found a nonsignificant trend toward lower mortality with restrictive transfusion practice.

Constraint-Induced Aphasia Therapy for Treatment of Chronic Post-Stroke Aphasia: A Randomized, Blinded, Controlled Pilot Trial.

Science.gov (United States)

Szaflarski, Jerzy P; Ball, Angel L; Vannest, Jennifer; Dietz, Aimee R; Allendorfer, Jane B; Martin, Amber N; Hart, Kimberly; Lindsell, Christopher J

2015-09-24

To provide a preliminary estimate of efficacy of constraint-induced aphasia therapy (CIAT) when compared to no-intervention in patients with chronic (>1 year) post-stroke aphasia in order to plan an appropriately powered randomized controlled trial (RCT). We conducted a pilot single-blinded RCT. 24 patients were randomized: 14 to CIAT and 10 to no-intervention. CIAT groups received up to 4 hours/day of intervention for 10 consecutive business days (40 hours or therapy). Outcomes were assessed within 1 week of intervention and at 1 and 12 weeks after intervention and included several linguistic measures and a measure of overall subjective communication abilities (mini-Communicative Abilities Log (mini-CAL)). Clinicians treating patients (CIAT group) did not communicate with other team members to maintain blinding and the testing team members were blinded to treatment group assignment. Overall, the results of this pilot RCT support the results of previous observational studies that CIAT may lead to improvements in linguistic abilities. At 12 weeks, the treatment group reported better subjective communication abilities (mini-CAL) than the no-intervention group (p=0.019). Other measures trended towards better performance in the CIAT group. In this pilot RCT intensive language therapy led to an improvement in subjective language abilities. The effects demonstrated allow the design of a definitive trial of CIAT in patients with a variety of post-stroke aphasia types. In addition, our experiences have identified important considerations for designing subsequent trial(s) of CIAT or other interventions for post-stroke aphasia.

Sleep education improves the sleep duration of adolescents: a randomized controlled pilot study.

Science.gov (United States)

Kira, Geoff; Maddison, Ralph; Hull, Michelle; Blunden, Sarah; Olds, Timothy

2014-07-15

To determine the feasibility and pilot a sleep education program in New Zealand high school students. A parallel, two-arm randomized controlled pilot trial was conducted. High school students (13 to 16 years) were randomly allocated to either a classroom-based sleep education program intervention (n = 15) or to a usual curriculum control group (n = 14). The sleep education program involved four 50-minute classroom-based education sessions with interactive groups. Students completed a 7-day sleep diary, a sleep questionnaire (including sleep hygiene, knowledge and problems) at baseline, post-intervention (4 weeks) and 10 weeks follow-up. An overall treatment effect was observed for weekend sleep duration (F 1,24 = 5.21, p = 0.03). Participants in the intervention group slept longer during weekend nights at 5 weeks (1:37 h:min, p = 0.01) and 10 weeks: (1:32 h:min, p = 0.03) compared to those in the control group. No differences were found between groups for sleep duration on weekday nights. No significant differences were observed between groups for any of the secondary outcomes (sleep hygiene, sleep problems, or sleep knowledge). A sleep education program appears to increase weekend sleep duration in the short term. Although this program was feasible, most schools are under time and resource pressure, thus alternative methods of delivery should be assessed for feasibility and efficacy. Larger trials of longer duration are needed to confirm these findings and determine the sustained effect of sleep education on sleep behavior and its impact on health and psychosocial outcomes. A commentary on this article appears in this issue on page 793.

Treatment of traumatic thoracolumbar spine fractures : A multicenter prospective randomized study of operative versus nonsurgical treatment

NARCIS (Netherlands)

Siebenga, Jan; Leferink, Vincent J. M.; Segers, Michiel J. M.; Elzinga, Matthijs J.; Bakker, Fred C.; Haarman, Henk J. Th. M.; Rommens, Pol M.; ten Duis, Henk-Jan; Patka, Peter

2006-01-01

Study Design. Multicenter prospective randomized trial. Objective. To test the hypotheses that thoracolumbar AO Type A spine fractures without neurologic deficit, managed with short-segment posterior stabilization will show an improved radiographic outcome and at least the same functional outcome as

Prevention of hypothermia in patients undergoing orthotopic liver transplantation using the humigard® open surgery humidification system: a prospective randomized pilot and feasibility clinical trial.

Science.gov (United States)

Weinberg, Laurence; Huang, Andrew; Alban, Daniel; Jones, Robert; Story, David; McNicol, Larry; Pearce, Brett

2017-01-23

Perioperative thermal disturbances during orthotopic liver transplantation (OLT) are common. We hypothesized that in patients undergoing OLT the use of a humidified high flow CO 2 warming system maintains higher intraoperative temperatures when compared to standardized multimodal strategies to maintain thermoregulatory homeostasis. We performed a randomized pilot study in adult patients undergoing primary OLT. Participants were randomized to receive either open wound humidification with a high flow CO 2 warming system in addition to standard care (Humidification group) or to standard care alone (Control group). The primary end point was nasopharyngeal core temperature measured 5 min immediately prior to reperfusion of the donor liver (Stage 3 - 5 min). Secondary endpoints included intraoperative PaCO 2 , minute ventilation and the use of vasoconstrictors. Eleven patients were randomized to each group. Both groups were similar for age, body mass index, MELD, SOFA and APACHE II scores, baseline temperature, and duration of surgery. Immediately prior to reperfusion (Stage 3 - 5 min) the mean (SD) core temperature was higher in the Humidification Group compared to the Control Group: 36.0 °C (0.13) vs. 35.4 °C (0.22), p = 0.028. Repeated measured ANOVA showed that core temperatures over time during the stages of the transplant were higher in the Humidification Group compared to the Control Group (p < 0.0001). There were no significant differences in the ETCO 2 , PaCO 2 , minute ventilation, or inotropic support. The humidified high flow CO 2 warming system was superior to standardized multimodal strategies in maintaining normothermia in patients undergoing OLT. Use of the device was feasible and did not interfere with any aspects of surgery. A larger study is needed to investigate if the improved thermoregulation observed is associated with improved patient outcomes. ACTRN12616001631493 . Retrospectively registered 25 November 2016.

Illness Management & Recovery (IMR) in the Netherlands : A naturalistic pilot study to explore the feasibility of a randomized controlled trial

NARCIS (Netherlands)

Roosenschoon, B.J.; Van Weeghel, J.; Bogaards, M.; Deen, M.L.; Mulder, C.L.

2016-01-01

Background Illness Management & Recovery (IMR) is a curriculum-based program for people with severe and persistent mental illness. To date, four randomized controlled trials (RCTs) have been published on it. As these produced mixed results, we conducted a pilot study to test the feasibility of

Illness Management & Recovery (IMR) in the Netherlands; a naturalistic pilot study to explore the feasibility of a randomized controlled trial

NARCIS (Netherlands)

B.J. Roosenschoon (Bert); J. van Weeghel (Jaap); Bogaards, M. (Moniek); M. Deen (Mathijs); C.L. Mulder (Niels)

2016-01-01

textabstractBackground: Illness Management & Recovery (IMR) is a curriculum-based program for people with severe and persistent mental illness. To date, four randomized controlled trials (RCTs) have been published on it. As these produced mixed results, we conducted a pilot study to test the

Online CBT life skills programme for low mood and anxiety: study protocol for a pilot randomized controlled trial.

Science.gov (United States)

Williams, Christopher; McClay, Carrie-Anne; Martinez, Rebeca; Morrison, Jill; Haig, Caroline; Jones, Ray; Farrand, Paul

2016-04-27

Low mood is a common mental health problem with significant health consequences. Studies have shown that cognitive behavioural therapy (CBT) is an effective treatment for low mood and anxiety when delivered one-to-one by an expert practitioner. However, access to this talking therapy is often limited and waiting lists can be long, although a range of low-intensity interventions that can increase access to services are available. These include guided self-help materials delivered via books, classes and online packages. This project aims to pilot a randomized controlled trial of an online CBT-based life skills course with community-based individuals experiencing low mood and anxiety. Individuals with elevated symptoms of depression will be recruited directly from the community via online and newspaper advertisements. Participants will be remotely randomized to receive either immediate access or delayed access to the Living Life to the Full guided online CBT-based life skills package, with telephone or email support provided whilst they use the online intervention. The primary end point will be at 3 months post-randomization, at which point the delayed-access group will be offered the intervention. Levels of depression, anxiety, social functioning and satisfaction will be assessed. This pilot study will test the trial design, and ability to recruit and deliver the intervention. Drop-out rates will be assessed and the completion and acceptability of the package will be investigated. The study will also inform a sample size power calculation for a subsequent substantive randomized controlled trial. ISRCTN ISRCTN12890709.

A prospective randomized clinical trial to evaluate methods of postoperative care of hypospadias.

Science.gov (United States)

McLorie, G; Joyner, B; Herz, D; McCallum, J; Bagli, D; Merguerian, P; Khoury, A

2001-05-01

Hypospadias repair is a common operation performed by pediatric urologists. Perhaps the greatest variable and source of controversy of postoperative care is the surgical dressing. We hypothesized that using no dressing would achieve surgically comparable results to those traditionally achieved by a postoperative dressing and it would also simplify postoperative parent delivered home care. Accordingly we designed a prospective randomized clinical trial to compare surgical outcome and postoperative care after hypospadias repair in boys with no dressing and those who received 1 of the 2 most common types of dressing. In a 12-month period 120 boys with an average age of 2.2 years underwent primary 1-stage hypospadias repair at a single center with 4 participating surgeons. Repair was performed in 60 boys with proximal and 60 with distal hypospadias on an outpatient basis. Ethics and Internal Review Board approval, and informed consent were obtained. Boys were then prospectively randomized to receive no dressing, an adhesive biomembrane dressing or a compressive wrap dressing. Comprehensive instructions on postoperative care were distributed to all families and a questionnaire was distributed to the parents at the initial followup. Surgical outcome was evaluated and questionnaire responses were analyzed. Fisher's exact test was done to test the significance of differences in surgical outcomes and questionnaire responses. A total of 117 boys completed the prospective randomized trial. Surgical staff withdrew 3 cases from randomized selection to place a dressing for postoperative hemostasis. We obtained 101 questionnaires for response analysis. The type or absence of the dressing did not correlate with the need for repeat procedures, urethrocutaneous fistula, or meatal stenosis or regression. Analysis revealed less narcotic use in the no dressing group and fewer telephone calls to the urology nurse, or on-call resident and/or fellow. These findings were statistically

One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.

OpenAIRE

Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Bergqvist, Christina Eten; Persson, Jan

2012-01-01

INTRODUCTION AND HYPOTHESIS: The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety. METHODS: We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60)...

A prospective, randomized study addressing the need for physical simulation following virtual simulation

International Nuclear Information System (INIS)

Valicenti, Richard K.; Waterman, Frank M.; Corn, Benjamin W.; Curran, Walter J.

1997-01-01

Purpose: To accurately implement a treatment plan obtained by virtual or CT simulation, conventional or physical simulation is still widely used. To evaluate the need for physical simulation, we prospectively randomized patients to undergo physical simulation or no additional simulation after virtual simulation. Methods and Materials: From July 1995 to September 1996, 75 patients underwent conformal four-field radiation therapy planning for prostate cancer with a commercial grade CT simulator. The patients were randomized to undergo either port filming immediately following physical simulation or port filming alone. The precision of implementing the devised plan was evaluated by comparing simulator radiographs and/or port films against the digitally reconstructed radiographs (DRRs) for x, y, and z displacements of the isocenter. Changes in beam aperture were also prospectively evaluated. Results: Thirty-seven patients were randomized to undergo physical simulation and first day port filming, and 38 had first day treatment verification films only without a physical simulation. Seventy-eight simulator radiographs and 195 first day treatment port films were reviewed. There was no statistically significant reduction in treatment setup error (>5 mm) if patients underwent physical simulation following virtual simulation. No patient required a resimulation, and there was no significant difference in changes of beam aperture. Conclusions: Following virtual simulation, physical simulation may not be necessary to accurately implement the conformal four-field technique. Because port filming appears to be sufficient to assure precise and reliable execution of a devised treatment plan, physical simulation may be eliminated from the process of CT based planning when virtual simulation is available

Cardiac effects of granisetron in a prospective crossover randomized dose comparison trial.

Science.gov (United States)

Cakir, F B; Yapar, O; Canpolat, C; Akalin, F; Berrak, S G

2012-10-01

Cardiac side effects of granisetron have been studied mostly in adult patients that are using cardiotoxic chemotherapeutics. There is limited evidence in pediatric age group and no information in pediatric oncology patients with non-cardiotoxic chemotherapeutics. In this prospective, crossover randomized study, the cardiac side effects of granisetron are compared in pediatric oncology patients who had carboplatin based chemotherapy. They were randomized to receive either 10 or 40 μg kg(-1) dose(-1) of granisetron before each cycle of chemotherapy. We drew blood for creatine phosphokinase (CPK), CPK-muscle band (MB) and Troponin-T before and 24 h after administering granisetron. Electrocardiography (ECG) tracings were taken at 0, 1, 2, 3, 6 and 24 h of granisetron. Twenty-four hours Holter ECG monitorisation was performed after each granisetron infusion. A total of 16 patients (median 8.7 years of age) were treated with weekly consecutive courses of carboplatin. There was bradycardia (p = 0.000) in patients that had granisetron at 40 μg/kg and PR interval was shortened in patients that had granisetron at 10 μg/kg dose (p = 0.021). At both doses of granisetron, QTc interval and dispersion were found to be similar. CPK, CK-MB and Troponin-T values were found to be normal before and 24 h after granisetron infusion. As the first study that has studied cardiac side effects of granisetron in patients that are not using cardiotoxic chemotherapeutics, we conclude that granisetron at 40 μg kg(-1) dose(-1) causes bradycardia only. We have also demonstrated that granisetron does not cause any clinically cardiac side effects either at 10 or 40 μg kg(-1) dose(-1). However, our results should be supported by prospective randomized studies with larger samples of patient groups.

Compression Stockings after Endovenous Laser Ablation of the Great Saphenous Vein : A Prospective Randomized Controlled Trial

NARCIS (Netherlands)

Bakker, N. A.; Schieven, L. W.; Bruins, R. M. G.; van den Berg, M.; Hissink, R. J.

2013-01-01

Objectives: To determine if the duration of wearing compression stockings after endovenous laser ablation (EVLA) of the great saphenous vein (GSV) has influence on pain and quality of life. Methods: This was a prospective randomized controlled trial. Between December 2006 and February 2008, 109

Prospective double blind randomized placebo-controlled clinical trial of the pectoral nerves (Pecs) block type II

NARCIS (Netherlands)

Versyck, B.; Geffen, G.J. van; Houwe, P. Van

2017-01-01

STUDY OBJECTIVE: The aim of this clinical trial was to test the hypothesis whether adding the pectoral nerves (Pecs) block type II to the anesthetic procedure reduces opioid consumption during and after breast surgery. DESIGN: A prospective randomized double blind placebo-controlled study. SETTING:

A pilot randomized crossover trial assessing the safety and short-term effects of pomegranate supplementation in hemodialysis patients.

Science.gov (United States)

Rivara, Matthew B; Mehrotra, Rajnish; Linke, Lori; Ruzinski, John; Ikizler, T Alp; Himmelfarb, Jonathan

2015-01-01

Oxidative stress and systemic inflammation are highly prevalent in patients undergoing maintenance hemodialysis (MHD) and are linked to excess cardiovascular risk. This study examined whether short-term supplementation with pomegranate juice and extract is safe and well tolerated by MHD patients. The secondary aim was to assess the effect of pomegranate supplementation on oxidative stress, systemic inflammation, monocyte function, and blood pressure. Prospective, randomized, crossover, pilot clinical trial (NCT01562340). The study was conducted from March to October 2012 in outpatient dialysis facilities in the Seattle metropolitan area. Twenty-four patients undergoing MHD (men, 64%; mean age, 61 ± 14 years) were randomly assigned to receive pomegranate juice or extract during a 4-week intervention period. After a washout period, all patients received the alternative treatment during a second 4-week intervention period. Patients assigned to receive pomegranate juice received 100 mL of juice before each dialysis session. Patients assigned to receive pomegranate extract were given 1,050 mg of extract daily. The main outcome measures were safety and tolerability of pomegranate juice and extract. Additional secondary outcomes assessed included serum lipids, laboratory biomarkers of inflammation (C-reactive protein and interleukin 6) and oxidative stress (plasma F2 isoprostanes and isofurans), monocyte cytokine production, and predialysis blood pressure. Both pomegranate juice and extract were safe and well tolerated by study participants. Over the study period, neither treatment had a significant effect on lipid profiles, plasma C-reactive protein, interleukin 6, F2-isoprostane or isofuran concentrations, predialysis systolic or diastolic blood pressure nor changed the levels of monocyte cytokine production. Both pomegranate juice and extract are safe and well tolerated by patients undergoing MHD but do not influence markers of inflammation or oxidative stress

Clinical impact of pharmacogenetic profiling with a clinical decision support tool in polypharmacy home health patients: A prospective pilot randomized controlled trial.

Directory of Open Access Journals (Sweden)

Lindsay S Elliott

Full Text Available In polypharmacy patients under home health management, pharmacogenetic testing coupled with guidance from a clinical decision support tool (CDST on reducing drug, gene, and cumulative interaction risk may provide valuable insights in prescription drug treatment, reducing re-hospitalization and emergency department (ED visits. We assessed the clinical impact of pharmacogenetic profiling integrating binary and cumulative drug and gene interaction warnings on home health polypharmacy patients.This prospective, open-label, randomized controlled trial was conducted at one hospital-based home health agency between February 2015 and February 2016. Recruitment came from patient referrals to home health at hospital discharge. Eligible patients were aged 50 years and older and taking or initiating treatment with medications with potential or significant drug-gene-based interactions. Subjects (n = 110 were randomized to pharmacogenetic profiling (n = 57. The study pharmacist reviewed drug-drug, drug-gene, and cumulative drug and/or gene interactions using the YouScript® CDST to provide drug therapy recommendations to clinicians. The control group (n = 53 received treatment as usual including pharmacist guided medication management using a standard drug information resource. The primary outcome measure was the number of re-hospitalizations and ED visits at 30 and 60 days after discharge from the hospital. The mean number of re-hospitalizations per patient in the tested vs. untested group was 0.25 vs. 0.38 at 30 days (relative risk (RR, 0.65; 95% confidence interval (CI, 0.32-1.28; P = 0.21 and 0.33 vs. 0.70 at 60 days following enrollment (RR, 0.48; 95% CI, 0.27-0.82; P = 0.007. The mean number of ED visits per patient in the tested vs. untested group was 0.25 vs. 0.40 at 30 days (RR, 0.62; 95% CI, 0.31-1.21; P = 0.16 and 0.39 vs. 0.66 at 60 days (RR, 0.58; 95% CI, 0.34-0.99; P = 0.045. Differences in composite outcomes at 60 days (exploratory endpoints

Pilot study on microvascular anastomosis: performance and future educational prospects.

Science.gov (United States)

Berretti, G; Colletti, G; Parrinello, G; Iavarone, A; Vannucchi, P; Deganello, A

2017-11-30

The introduction of microvascular free flaps has revolutionised modern reconstructive surgery. Unfortunately, access to training opportunities at standardised training courses is limited and expensive. We designed a pilot study on microvascular anastomoses with the aim of verifying if a short course, easily reproducible, could transmit microvascular skills to participants; if the chosen pre-test was predictive of final performance; and if age could influence the outcome. A total of 30 participants (10 students, 10 residents and 10 surgeons) without any previous microvascular experience were instructed and tested during a single 3 to 5 hour course. The two microanastomoses evaluated were the first ever performed by each participant. More than the half of the cohort was able to produce both patent microanastomoses in less than 2 hours; two-thirds of the attempted microanastomoses were patent. The pretest predicted decent scores from poor performances with a sensitivity of 61.5%, specificity of 100%, positive predictive value of 100% and negative predictive value of 40%. Students and residents obtained significantly higher scores than surgeons. Since our course model is short, cost-effective and highly reproducible, it could be introduced and implemented anywhere as an educational prospect for preselecting young residents showing talent and natural predisposition and having ambitions towards microvascular reconstructive surgery. © Copyright by Società Italiana di Otorinolaringologia e Chirurgia Cervico-Facciale.

Teacher-Child Interaction Training: A Pilot Study With Random Assignment.

Science.gov (United States)

Fernandez, Melanie A; Adelstein, Jonathan S; Miller, Samantha P; Areizaga, Margaret J; Gold, Dylann C; Sanchez, Amanda L; Rothschild, Sara A; Hirsch, Emily; Gudiño, Omar G

2015-07-01

Teacher-Child Interaction Training (TCIT), adapted from Parent-Child Interaction Therapy (PCIT), is a classroom-based program designed to provide teachers with behavior management skills that foster positive teacher-student relationships and to improve student behavior by creating a more constructive classroom environment. The purpose of this pilot study was to evaluate TCIT in more classrooms than previously reported in the literature, with older children than previously reported, using random assignment of classrooms to TCIT or to a no-TCIT control condition and conducting all but two sessions within the classroom to enhance feasibility. Participants included 11 kindergarten and first grade classroom teachers and their 118 students from three urban, public schools in Manhattan, with five classrooms randomly assigned to receive TCIT and six to the no-TCIT control condition. Observations of teacher skill acquisition were conducted before, during, and after TCIT for all 11 teachers, and teacher reports of student behavior were obtained at these same time points. Teacher satisfaction with TCIT was assessed following training. Results suggested that after receiving TCIT, teachers increased rates of positive attention to students' appropriate behavior, decreased rates of negative attention to misbehavior, reported significantly less distress related to student disruptive behavior, and reported high satisfaction with the training program. Our study supports the growing evidence-base suggesting that TCIT is a promising approach for training teachers in positive behavior management strategies and for improving student disruptive behavior in the classroom. Copyright © 2015. Published by Elsevier Ltd.

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

Science.gov (United States)

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

2015-01-01

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

[Pilot testing of an internet based pregnancy planning study "Snart-gravid.dk"].

Science.gov (United States)

Mikkelsen, Ellen M; Maindal, Helle Terkildsen

2011-01-01

Before launching a new study pilot testing is often recommended, however, it is seldom described in depth. Here, we report extensively on a pilot study using the internet as a new method for recruitment and data collection in a prospective cohort study of women planning a pregnancy.We aimed to enroll 2500 participants in six months and attained more than 75 % after 12 months follow up. To test data completeness and validity we randomized participants to fill either a long or a short version of the baseline questionnaire and compared self reported data with registry based data.We succeeded in enrolling 2288 participants, and participation rate was 82 % after 12 months. We found high correlations (0.96) for self-reported vs. registry based data and no difference in participation rate or data completeness according to questionnaire length. Overall, the internet based methods seem promising and we plan to launch the full study.

Red blood cell transfusion triggers in acute leukemia: a randomized pilot study.

Science.gov (United States)

DeZern, Amy E; Williams, Katherine; Zahurak, Marianna; Hand, Wesley; Stephens, R Scott; King, Karen E; Frank, Steven M; Ness, Paul M

2016-07-01

Red blood cell (RBC) transfusion thresholds have yet to be examined in large randomized trials in hematologic malignancies. This pilot study in acute leukemia uses a restrictive compared to a liberal transfusion strategy. A randomized (2:1) study was conducted of restrictive (LOW) hemoglobin (Hb) trigger (7 g/dL) compared to higher (HIGH) Hb trigger (8 g/dL). The primary outcome was feasibility of conducting a larger trial. The four requirements for success required that more than 50% of the eligible patients could be consented, more than 75% of the patients randomized to the LOW arm tolerated the transfusion trigger, fewer than 15% of patients crossed over from the LOW arm to the HIGH arm, and no indication for the need to pause the study for safety concerns. Secondary outcomes included fatigue, bleeding, and RBCs and platelets transfused. Ninety patients were consented and randomly assigned to LOW to HIGH. The four criteria for the primary objective of feasibility were met. When the number of units transfused was compared, adjusting for baseline Hb, the LOW arm was transfused on average 8.0 (95% confidence interval [CI], 6.9-9.1) units/patient while the HIGH arm received 11.7 (95% CI, 10.1-13.2) units (p = 0.0003). There was no significant difference in bleeding events or neutropenic fevers between study arms. This study establishes feasibility for trial of Hb thresholds in leukemia through demonstration of success in all primary outcome metrics and a favorable safety profile. This population requires further study to evaluate the equivalence of liberal and restrictive transfusion thresholds in this unique clinical setting. © 2016 AABB.

Alveolar ridge preservation using autogenous tooth graft versus beta-tricalcium phosphate alloplast: A randomized, controlled, prospective, clinical pilot study

Directory of Open Access Journals (Sweden)

Chaitanya Pradeep Joshi

2016-01-01

Full Text Available Background: A randomized, prospective clinical, radiographical, and histological study was conducted to evaluate healing after alveolar ridge preservation technique using two different graft materials, namely, a novel autogenous graft material i. e., autogenous tooth graft (ATG and beta-tricalcium phosphate (β-TCP alloplast. Materials and Methods: Fifteen patients undergoing extraction of at least three teeth were selected. Atraumatic extractions were performed. Of the three extraction sockets, one was grafted with ATG, other with β-TCP, and the third was left ungrafted. Cone-beam computed tomography scans were taken immediately after grafting and 4 months postoperatively to check the changes in alveolar crest height and width at all the sites. Three patients in whom implant placement was done after complete healing; bone samples were harvested using a 3 mm diameter trephine during osteotomy preparation from both the ridge preserved sites and studied histologically. Results: There was a statistically significant difference when the changes in width and height of alveolar crest were compared within all the three groups (P < 0.05. Among three sites, ATG-grafted sites showed the most superior results with a minimal reduction in alveolar crest height and width. Histological analysis also showed the same trend with more new bone formation at ATG-grafted sites as compared to β-TCP-grafted sites. Conclusion: Postextraction, ridge preservation leads to more predictable maintenance of alveolar ridge height and width. ATG as compared to β-TCP provided superior results. Based on this, we conclude that ATG material can serve as a better alternative to conventional bone graft materials.

Supporting parents in taking care of their infants admitted to a neonatal intensive care unit: a prospective cohort pilot study.

Science.gov (United States)

De Bernardo, Giuseppe; Svelto, Maria; Giordano, Maurizio; Sordino, Desiree; Riccitelli, Marina

2017-04-17

Family-Centred Care (FCC) is recognized as an important component of all paediatric care, including neonatal care, although practical clinical guidelines to support this care model are still needed in Italy. The characteristics and services for families in Italian NICUs show a lack of organization and participation. The first aim was to compare satisfaction and stress levels in two groups of parents: an FCC group and a non-FCC group (NFCC). The second aim was to evaluate body weight gain in the newborns enrolled. This non-randomized, prospective cohort pilot study was conducted in a single level III NICU at a hospital in Naples, Italy. A cohort of newborns in the NICU, with their parents were enrolled between March 2014 and April 2015 and they were divided into two groups: the FCC group (enrolled between October 2014 and April 2015) remained in the NICU for 8 h a day with FCC model; the NFCC group (enrolled between March 2014 and September 2014) was granted access to the NICU for only 1 hour per day. At discharge, both parent groups completed the Parental Stressor Scale (PSS)-NICU and a questionnaire to assess their satisfaction. In addition, we compared scores from the mothers and fathers within and between groups and the body weights of the newborns in the two groups at 60 days. Parents participating in the FCC group were more satisfied and less stressed than those in the NFCC group. Infants in the FCC group also showed increased body weight after 60 days of hospital stay. Despite our small population, we confirm that routine adoption of a procedure designed to apply a FCC model can contribute to improving satisfaction and distress among preterm infants' parents. Future multi-centre, randomized, controlled trials are needed to confirm these findings.

A prospective, randomized multicenter study comparing APD and CAPD treatment

DEFF Research Database (Denmark)

Bro, S; Bjorner, J B; Tofte-Jensen, P

2000-01-01

, dialysis-related complications, dialysis-related expenses. RESULTS: The quality-of-life studies showed that significantly more time for work, family, and social activities was available to patients on APD compared to those on CAPD (p ...) treatment with respect to quality of life and clinical outcomes in relation to therapy costs. DESIGN: A prospective, randomized multicenter study. SETTING: Three Danish CAPD units. PATIENTS: Thirty-four adequately dialyzed patients with high or high-average peritoneal transport characteristics were included...... were assessed at baseline and after 6 months by the self-administered short-form SF-36 generic health survey questionnaire supplemented with disease- and treatment-specific questions. Therapy costs were compared by evaluating dialysis-related expenses. MAIN OUTCOME MEASURES: Quality-of-life parameters...

Gentamicin-collagen sponge reduces sternal wound complications after heart surgery : A controlled, prospectively randomized, double-blind study

NARCIS (Netherlands)

Schimmer, Christoph; Oezkur, Mehmet; Sinha, Bhanu; Hain, Johannes; Gorski, Armin; Hager, Benjamin; Leyh, Rainer

Objective: Prophylactic retrosternal placement of a gentamicin-collagen sponge has been the subject of several recent clinical studies and is a matter of controversy. The present study is the first controlled, prospective, randomized, double-blind, single-center study to investigate the efficacy of

Cognitive Analytic Therapy for Bipolar Disorder: A Pilot Randomized Controlled Trial.

Science.gov (United States)

Evans, Mark; Kellett, Stephen; Heyland, Simon; Hall, Jo; Majid, Shazmin

2017-01-01

The evidence base for treatment of bipolar affective disorder (BD) demands the evaluation of new psychotherapies in order to broaden patient choice. This study reports on the feasibility, safety, helpfulness and effectiveness of cognitive analytic therapy (CAT). In a pilot randomized controlled trial, BD patients in remission were randomized to either receiving 24 sessions of CAT (n = 9) or treatment as usual (n = 9) and were assessed in terms of symptoms, functioning and service usage over time. In the CAT arm no adverse events occurred, 8/9 completed treatment, 5/8 attended all 24 sessions and 2/8 were categorized as recovered. The most common helpful event during CAT was recognition of patterns in mood variability, with helpfulness themes changing according to phase of therapy. No major differences were found when comparing the arms over time in terms of service usage or psychometric outcomes. The study suggests that conducting further research into the effectiveness of CAT in treating BD is warranted and guidance regarding future trials is provided. Copyright © 2016 John Wiley & Sons, Ltd. Treating BD with CAT appears feasible and safe. Retaining fidelity to the reformulation, recognition and revision structure of CAT appears useful. Participants stated that across the phases of CAT, focussing on patterns of mood variability was consistently helpful. Copyright © 2016 John Wiley & Sons, Ltd.

TEACCH-based group social skills training for children with high-functioning autism: a pilot randomized controlled trial.

Science.gov (United States)

Ichikawa, Kayoko; Takahashi, Yoshimitsu; Ando, Masahiko; Anme, Tokie; Ishizaki, Tatsuro; Yamaguchi, Hinako; Nakayama, Takeo

2013-10-01

Although social skills training programs for people with high-functioning autism (HFA) are widely practiced, the standardization of curricula, the examination of clinical effectiveness, and the evaluation of the feasibility of future trials have yet to be done in Asian countries. To compensate for this problem, a Japanese pilot randomized controlled trial (RCT) of the Treatment and Education of Autistic and Related Communication Handicapped Children (TEACCH)-based group social skills training for children with HFA and their mothers was conducted. Eleven children with HFA, aged 5-6 years, and their mothers were randomly assigned to the TEACCH program (n=5) or a waiting-list control group (n=6). The program involved comprehensive group intervention and featured weekly 2-hour sessions, totaling 20 sessions over six months. The adaptive behaviors and social reciprocity of the children, parenting stress, and parent-child interactions were assessed using the Strengths and Difficulties Questionnaire (SDQ), Parenting Stress Index (PSI), Beck depression inventory-II (BDI-II), and Interaction Rating Scale (IRS). Through this pilot trial, the intervention and evaluation of the program has been shaped. There were no dropouts from the program and the mothers' satisfaction was high. The outcome measurements improved more in the program group than in the control group, with moderate effect sizes (SDQ, 0.71; PSI, 0.58; BDI-II, 0.40; and IRS, 0.69). This pilot trial also implied that this program is more beneficial for high IQ children and mothers with low stress than for those who are not. We have standardized the TEACCH program, confirmed the feasibility of a future trial, and successfully estimated the positive effect size. These findings will contribute to a larger trial in the future and to forthcoming systematic reviews with meta-analyses. UMIN000004560.

A Randomized Controlled Pilot Intervention Study of a Mindfulness-Based Self-Leadership Training (MBSLT) on Stress and Performance

OpenAIRE

Sampl, Juliane; Maran, Thomas; Furtner, Marco R.

2017-01-01

The present randomized pilot intervention study examines the effects of a mindfulness-based self-leadership training (MBSLT) specifically developed for academic achievement situations. Both mindfulness and self-leadership have a strong self-regulatory focus and are helpful in terms of stress resilience and performance enhancements. Based on several theoretical points of contact and a specific interplay between mindfulness and self-leadership, the authors developed an innovative intervention p...

Overcoming Barriers to Disseminating Exposure Therapies for Anxiety Disorders: A Pilot Randomized Controlled Trial of Training Methods

OpenAIRE

Harned, Melanie S.; Dimeff, Linda A.; Woodcock, Eric A.; Skutch, Julie M.

2011-01-01

The present study evaluated methods for training mental health providers (N=46) in exposure therapies (ETs) for anxiety disorders. A pilot randomized controlled trial compared: 1) an interactive, multimedia online training (ET OLT), 2) the ET OLT plus a brief Motivational Interviewing-based intervention (ET OLT + MI), and 3) a placebo control OLT. Assessments were completed at baseline, post-training, and one week following training. Both ET OLT and ET OLT + MI received high satisfaction rati...

EFFICACY OF SPINAL-CORD STIMULATION AS ADJUVANT THERAPY FOR INTRACTABLE ANGINA-PECTORIS - A PROSPECTIVE, RANDOMIZED CLINICAL-STUDY

NARCIS (Netherlands)

DEJONGSTE, MJL; HAUTVAST, RWM; HILLEGE, HL; LIE, KI

Objectives. In a prospective, randomized study with an 8-week follow-up period, we evaluated the efficacy of spinal cord stimulation an exercise capacity and quality of life in patients with intractable angina. Background. Despite important achievements in therapy for ischemic heart disease, there

Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial.

Science.gov (United States)

Merkely, Bela; Kosztin, Annamaria; Roka, Attila; Geller, Laszlo; Zima, Endre; Kovacs, Attila; Boros, Andras Mihaly; Klein, Helmut; Wranicz, Jerzy K; Hindricks, Gerhard; Clemens, Marcell; Duray, Gabor Z; Moss, Arthur J; Goldenberg, Ilan; Kutyifa, Valentina

2017-09-01

There is lack of conclusive evidence from randomized clinical trials on the efficacy and safety of upgrade to cardiac resynchronization therapy (CRT) in patients with implanted pacemakers (PM) or defibrillators (ICD) with reduced left ventricular ejection fraction (LVEF) and chronic heart failure (HF). The BUDAPEST-CRT Upgrade Study was designed to compare the efficacy and safety of CRT upgrade from conventional PM or ICD therapy in patients with intermittent or permanent right ventricular (RV) septal/apical pacing, reduced LVEF, and symptomatic HF. The BUDAPEST-CRT study is a prospective, randomized, multicentre, investigator-sponsored clinical trial. A total of 360 subjects will be enrolled with LVEF ≤ 35%, NYHA functional classes II-IVa, paced QRS ≥ 150 ms, and a RV pacing ≥ 20%. Patients will be followed for 12 months. Randomization is performed in a 3:2 ratio (CRT-D vs. ICD). The primary composite endpoint is all-cause mortality, a first HF event, or less than 15% reduction in left ventricular (LV) end-systolic volume at 12 months. Secondary endpoints are all-cause mortality, all-cause mortality or HF event, and LV volume reduction at 12 months. Tertiary endpoints include changes in quality of life, NYHA functional class, 6 min walk test, natriuretic peptides, and safety outcomes. The results of our prospective, randomized, multicentre clinical trial will provide important information on the role of cardiac resynchronization therapy with defibrillator (CRT-D) upgrade in patients with symptomatic HF, reduced LVEF, and wide-paced QRS with intermittent or permanent RV pacing. NCT02270840. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

Prevention of lymphocele by using gelatin-thrombin matrix as a tissue sealant after pelvic lymphadenectomy in patients with gynecologic cancers: a prospective randomized controlled study.

Science.gov (United States)

Kim, Yun Hwan; Shin, Hyun Joo; Ju, Woong; Kim, Seung Cheol

2017-05-01

This prospective randomized controlled pilot study aimed to find whether gelatin-thrombin matrix used as a tissue sealant (FloSeal) can prevent the occurrence of pelvic lymphocele in patients with gynecologic cancer who has undergone pelvic lymphadenectomy. Each patient, who undergo a laparotomic pelvic lymph node dissection on both sides, was randomly assigned for FloSeal application on 1 side of the pelvis. The other side of the pelvis without any product application being the control side. The amount of lymph drainage at each side of the pelvis was measured for 3 days, and computed tomography scans were obtained 7 days and 6 months after surgery for detection of pelvic lymphocele. Among 37 cases, the median amount of lymph drainage was significantly decreased in the hemi-pelvis treated with FloSeal compared to the control hemi-pelvis (p=0.025). The occurrence of lymphocele was considerably reduced in treated hemi-pelvis (8/37, 21.6%) compared with control hemi-pelvis (12/37, 32.4%) after 7 post-operative days (p=0.219), and more decreased in the treated hemi-pelvis (5/37, 13.5%) compared with control hemi-pelvis (9/37, 24.3%) after postoperative 6 months (p=0.344). The application of FloSeal as a tissue sealant in lymph nodes resected tissues can reduce the incidence of pelvic lymphocele in gynecologic cancer patients. A large randomized controlled study could confirm these preliminary results. Copyright © 2017. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology

Prospective randomized study comparing coronary artery bypass grafting with the new mini-extracorporeal circulation Jostra System or with a standard cardiopulmonary bypass.

Science.gov (United States)

Remadi, Jean Paul; Rakotoarivelo, Zava; Marticho, Paul; Benamar, Amar

2006-01-01

To assess the potential benefits of a new concept of cardiopulmonary bypass (CPB), the mini-extracorporeal circulation (MECC) Jostra System, we conducted a prospective randomized study among patients who underwent coronary artery bypass grafting (CABG) with a MECC Jostra System or with a standard CPB. In a prospective randomized study, 400 patients underwent elective CABG using a standard CPB (200 patients) or a Jostra MECC System (200 patients). The patients were randomly assigned to have preoperative data similar for both groups. The operative mortality rate (system is a new concept of CPB that seems to be reliable and safe. To perform CABG, the MECC provides an excellent surgical exposure like a standard CPB and a better biologic profile like CABG without CPB.

Prospective randomized trial compares suction versus water seal for air leaks.

Science.gov (United States)

Cerfolio, R J; Bass, C; Katholi, C R

2001-05-01

Surgeons treat air leaks differently. Our goal was to evaluate whether it is better to place chest tubes on suction or water seal for stopping air leaks after pulmonary surgery. A second goal was to evaluate a new classification system for air leaks that we developed. Patients were prospectively randomized before surgery to receive suction or water seal to their chest tubes on postoperative day (POD) #2. Air leaks were described and quantified daily by a classification system and a leak meter. The air-leak meter scored leaks from 1 (least) to 7 (greatest). The group randomized to water seal stayed on water seal unless a pneumothorax developed. On POD #2, 33 of 140 patients had an air leak. Eighteen patients had been preoperatively randomized to water seal and 15 to suction. Air leaks resolved in 12 (67%) of the water seal patients by the morning of POD #3. All 6 patients whose air leak did not stop had a leak that was 4/7 or greater (p leak meter. Of the 15 patients randomized to suction, only 1 patient's air leak (7%) resolved by the morning of POD #3. The randomization aspect of the trial was ended and statistical analysis showed water seal was superior (p = 0.001). The remaining 14 patients were then placed to water seal and by the morning of POD #4, 13 patients' leaks had stopped. Of the 32 total patients placed to seal, 7 (22%) developed a pneumothorax and 6 of these 7 patients had leaks that were 4/7 or greater (p = 0.001). Placing chest tubes on water seal seems superior to wall suction for stopping air leaks after pulmonary resection. However, water seal does not stop expiratory leaks that are 4/7 or greater. Pneumothorax may occur when chest tubes are placed on seal with leaks this large.

Prospective randomized trial of sclerotherapy vs standard treatment for epistaxis due to hereditary hemorrhagic telangiectasia.

Science.gov (United States)

Boyer, Holly; Fernandes, Patricia; Le, Chap; Yueh, Bevan

2015-05-01

Our previous studies have demonstrated the tolerability and low side-effect profile of office-based sclerotherapy with sodium tetradecyl sulfate (STS) for treating recurrent epistaxis due to hereditary hemorrhagic telangiectasia (HHT). The objective of this study was to use a prospective randomized trial to determine the effectiveness of sclerotherapy with STS vs standard treatment. This prospective randomized trial (conducted from November 1, 2011, through January 31, 2014) involved 17 patients with recurrent epistaxis due to HHT. We defined standard treatment as continuation of any treatment that the patient had previously undergone, such as moisturization, packing, and cautery. We used a crossover design, so study participants were randomized to either sclerotherapy or standard treatment during the first time period, and then to the other during the second period. The primary outcome measure was frequency and severity of epistaxis, as measured by the epistaxis severity score (ESS). The ESS is a 10-point scale, with higher scores corresponding to more bleeding. After controlling for treatment order, bleeding was substantially better controlled after sclerotherapy; the ESS after sclerotherapy was nearly one point lower than after standard treatment (-0.95, 1-sided p = 0.027). Treatment order, baseline ESS, the number of lesions, moisturization practices, and a history of previous blood transfusions did not significantly affect the results. This trial demonstrated that sclerotherapy with STS (vs standard treatment) significantly reduced epistaxis due to HHT. © 2015 ARS-AAOA, LLC.

Music for surgical abortion care study: a randomized controlled pilot study.

Science.gov (United States)

Wu, Justine; Chaplin, William; Amico, Jennifer; Butler, Mark; Ojie, Mary Jane; Hennedy, Dina; Clemow, Lynn

2012-05-01

The study objective was to explore the effect of music as an adjunct to local anesthesia on pain and anxiety during first-trimester surgical abortion. Secondary outcomes included patient satisfaction and coping. We conducted a randomized controlled pilot study of 26 women comparing music and local anesthesia to local anesthesia alone. We assessed pain, anxiety and coping with 11-point verbal numerical scales. Patient satisfaction was measured via a 4-point Likert scale. In the music group, we noted a trend toward a faster decline in anxiety postprocedure (p=.065). The music group reported better coping than the control group (mean±S.D., 8.5±2.3 and 6.2±2.8, respectively; pMusic as an adjunct to local anesthesia during surgical abortion is associated with a trend toward less anxiety postprocedure and better coping while maintaining high patient satisfaction. Music does not appear to affect abortion pain. Copyright © 2012 Elsevier Inc. All rights reserved.

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

Science.gov (United States)

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

2012-04-01

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

A play and joint attention intervention for teachers of young children with autism: a randomized controlled pilot study.

Science.gov (United States)

Wong, Connie S

2013-05-01

The aim of this study was to pilot test a classroom-based intervention focused on facilitating play and joint attention for young children with autism in self-contained special education classrooms. Thirty-three children with autism between the ages of 3 and 6 years participated in the study with their classroom teachers (n = 14). The 14 preschool special education teachers were randomly assigned to one of three groups: (1) symbolic play then joint attention intervention, (2) joint attention then symbolic intervention, and (3) wait-list control period then further randomized to either group 1 or group 2. In the intervention, teachers participated in eight weekly individualized 1-h sessions with a researcher that emphasized embedding strategies targeting symbolic play and joint attention into their everyday classroom routines and activities. The main child outcome variables of interest were collected through direct classroom observations. Findings indicate that teachers can implement an intervention to significantly improve joint engagement of young children with autism in their classrooms. Furthermore, multilevel analyses showed significant increases in joint attention and symbolic play skills. Thus, these pilot data emphasize the need for further research and implementation of classroom-based interventions targeting play and joint attention skills for young children with autism.

Intrapleural chemo- and hyperthermotherapies for malignant pleural effusion: a randomized prospective study.

Science.gov (United States)

Chen, Wen-Jun; Yuan, Shao-Fei; Yan, Qing-Yuan; Xiong, Jian-Ping; Wang, Sen-Ming; Zheng, Wei-E; Zhang, Wu; Sun, Hong-Yu; Chen, Hua; Wu, Li-Li

2012-02-01

The current prospective randomized study was designed to evaluate the safety and efficacy of combined intrapleural cisplatin and OK-432 (picibanil) plus hyperthermotherapy in patients with malignant pleural effusion (MPE). A total of 358 patients with MPE due to end-stage malignancies were enrolled and randomly divided into two groups, A and B: the intrapleural combination of cisplatin and OK-432 with hyperthermotherapy (n = 179) or without hyperthermotherapy (n = 179), respectively. Mild toxicities such as nausea, vomiting or anorexia, bone marrow depression, and pyrexia were similar in both groups. Patients in Group A (with hyperthermotherapy) showed a significantly higher overall response (93.4%) compared to those in Group B (79.8%, χ(2) = 43.11, p .05). After treatment, the quality of life scores were significantly increased in both groups as compared to prior treatment (p < .05). In conclusion, our study suggests that combined intrapleural cisplatin and OK-432 followed by hyperthermotherapy are more effective in the control of MPE and improve patients' quality of life.

Muscle energy technique compared to eccentric loading exercise in the management of achilles tendinitis: A pilot randomized controlled trial

Directory of Open Access Journals (Sweden)

Hariharasudhan Ravichandran

2017-01-01

Full Text Available Background: Achilles tendinitis is a common overuse injury among both elite and recreational athletes involved in activities such as repetitive jumping and running. Aim: The aim of this single-blinded randomized study was to compare the efficacy of muscle energy technique (MET and eccentric loading exercise (ELE interventions on improving functional ability and pain reduction among athletes with Achilles tendinitis. Methods: A single-blinded, pilot, randomized study was conducted in the Department of Physical Therapy, Global Hospitals and Health City, India, with 6-week follow-up. A total of 30 patients with Achilles tendinitis were randomly allocated to receive either MET (n = 15 or ELE (n = 15 treatment. Treatment effects were evaluated by pre- and post-treatment assessment of visual analog scale (VAS and Victorian Institute of Sports Assessment-Achilles (VISA-A questionnaire. Measures were performed by single-blinded evaluators at baseline and at 2, 4, and after 6 weeks of treatment. Results: Both groups showed a significant difference in VAS after 6 weeks' ELE group showed a significant improvement during treatment at 2 and 4 weeks in comparison with MET group. The VISA-A scale score significantly improved in both groups. Yet, comparison of VISA scores between groups showed marginally significant difference (P = 0.012. Conclusion: This pilot randomized controlled trial (RCT showed the efficacy of ELE in reducing pain and improving functional ability among patients with Achilles tendinitis. The findings of this study provide the rationale for undertaking a large-scale RCT. A large sized trial is needed to establish evidence for clinical practice of ELE in Achilles tendinitis cases.

Effects of manipulating eating frequency during a behavioral weight loss intervention: a pilot randomized controlled trial.

Science.gov (United States)

Bachman, Jessica L; Raynor, Hollie A

2012-05-01

Eating frequency has been inversely related to BMI but the impact of eating frequency on weight loss is unclear. This randomized controlled trial pilot study examined the effect of eating frequency on hunger, energy intake, and weight loss during a 6-month behavioral weight loss intervention. Participants (age: 51.0 ± 9.9 years, BMI: 35.5 ± 4.8 kg/m(2), 57.8% female, 94.1% white) were randomized to one of two eating frequency prescriptions: Three meal (n = 25): three eating bouts/day; or grazing (n = 26): eat at least 100 kcals every 2-3 h. Both groups attended 20 sessions and had identical dietary (1,200-1,500 kcals/day, frequency than three meal at 6 months (5.8 ± 1.1 eating bouts/day vs. 3.2 ± 0.6 eating bouts/day, P weight loss intervention.

Acupuncture in the treatment of rheumatoid arthritis: a double-blind controlled pilot study

Directory of Open Access Journals (Sweden)

Zhang Lang

2007-11-01

Full Text Available Abstract Background In planning a randomized controlled trial of acupuncture, we conducted a pilot study using validated outcome measures to assess the feasibility of the protocol, and to obtain preliminary data on efficacy and tolerability of 3 different forms of acupuncture treatment as an adjunct for the treatment of chronic pain in patients with Rheumatoid arthritis (RA. Methods The study employs a randomized, prospective, double-blind, placebo-controlled trial to evaluate the effect of electroacupuncture (EA, traditional Chinese acupuncture (TCA and sham acupuncture (Sham in patients with RA. All patients received 20 sessions over a period of 10 weeks. Six acupuncture points were chosen. Primary outcome is the changes in the pain score. Secondary outcomes included the changes in the ACR core disease measures, DAS 28 score and the number of patients who achieved ACR 20 at week 10. Results From 80 eligible patients, 36 patients with mean age of 58 ± 10 years and disease duration of 9.3 ± 6.4 years were recruited. Twelve patients were randomized to each group. Twelve, 10 and 7 patients from the EA, TCA and Sham group respectively completed the study at 20 weeks (p Conclusion This pilot study has allowed a number of recommendations to be made to facilitate the design of a large-scale trial, which in turn will help to clarify the existing evidence base on acupuncture for RA. Trial registration ClinicalTrials.gov NCT00404443

TORPEDO: Prospective, double blind, randomized clinical trial comparing the use of Ketorolac verse placebo during live donor nephrectomy for kidney transplant

Directory of Open Access Journals (Sweden)

Jeffrey Campsen

2017-06-01

Full Text Available The aim of this pilot study was to determine if the use of Ketorolac for donor nephrectomies could decrease the use of narcotics. Methods: This is a prospective, double blind, randomized trial involving patients undergoing nephrectomy for live donor kidney transplantation. Three arms: 1. Ketorolac 30 mg IV×1 in the OR, then ketorolac 15 mg IV every 6 h for 7 doses. 2. Ketorolac 30 mg IV×1 in the OR, then placebo IV every 6 h for 7 doses. 3. Placebo IV×1 in the OR, then placebo IV every 6 h for 7 doses. Outcomes: blood loss, mortality, renal function, cumulative narcotic use, length of hospital stay (LOS, and urinary retention. Results: There were no patient deaths, blood transfusions or renal dysfunction in any study arm. Arm 1 had less narcotic use, reduced length of stay, and reduced urinary retention than Arm 3. Conclusion: There was reduced LOS, less narcotic use and less urinary retention in the Ketorolac group (Arm 1 versus the placebo group (Arm 3. Based on these results we will proceed with a larger study to compare the use of non-opioid analgesics in donor nephrectomies.

Activation of Coagulation and Fibrinolysis in Acute Respiratory Distress Syndrome: a Prospective Pilot Study

Directory of Open Access Journals (Sweden)

Agnese Ozolina

2016-11-01

Full Text Available Introduction: Coagulation and fibrinolysis remain sparsely addressed with regards to acute respiratory distress syndrome (ARDS. We hypothesized that ARDS development might be associated with changes in plasma coagulation and fibrinolysis. Our aim was to investigate the relationships between ARDS diagnosis and plasma concentrations of tissue factor (TF, tissue plasminogen activator (t-PA and plasminogen activator inhibitor-1 (PAI-1 in mechanically ventilated patients at increased risk of developing ARDS. Materials and Methods: We performed an ethically approved prospective observational pilot study. Inclusion criteria: patients with PaO2/FiO2 < 300 mmHg admitted to the intensive care unit (ICU for mechanical ventilation for 24 hours, or more, because of one or more disease conditions associated with increased risk of developing ARDS. Exclusion criteria: age below 18 years; cardiac disease. We sampled plasma prospectively and compared patients who developed ARDS with those who did not using descriptive statistics and chi-square analysis of baseline demographical and clinical data. We also analyzed plasma concentrations of TF, t-PA and PAI-1 at inclusion (T0 and on third (T3 and seventh day (T7 of the ICU stay with non-parametric statistics inclusive their sensitivity and specificity associated with the development of ARDS using receiver operating characteristic (ROC curve analysis. Statistical significance: p < 0.05.Results: Of 24 patients at risk, six developed mild ARDS and four of each moderate or severe ARDS, respectively, 3 ± 2 (Mean ± SD days after inclusion. Median plasma concentrations of TF and PAI-1 were significantly higher at T7 in patients with ARDS, as compared to non-ARDS. Simultaneously, we found moderate correlations between plasma concentrations of TF and PAI-1, TF and PaO2/FiO2 and PEEP and TF. TF plasma concentration was associated with ARDS with 71% sensitivity and 100% specificity, a cut off level of 145 pg/ml and AUC 0

Treatment of patients with severe sepsis using Ulinastatin and Thymosin α1: a prospective, randomized, controlled pilot study

Institute of Scientific and Technical Information of China (English)

CHEN Hao; HE Ming-yan; LI Yu-min

2009-01-01

Background Tradition treatment of sepsis and new therapies, including high dose corticosteroids and non-steroidal anti-inflammatory drugs, have proven unsuccessful in improving survival. This study aimed to evaluate the potential efficacy of immunomodulating therapy using Ulinastatin (UTI) plus Thymosin α1 (Tα1) for improving organ function and reducing mortality in patients with severe sepsis.Methods A prospective study was carried out with randomized and controlled clinical analysis of 114 patients conforming to the enrollment standard. All patients had severe sepsis and received standard supportive care and antimicrobial therapy. Fifty-nine patients were also administered UTI plus Tα1 (defined as Group A), 55 patients were given a placebo (defined as Group B). Clinical parameters were determined by evaluation with the Acute Physiology and Chronic Health Evaluation Ⅱ (APACHE Ⅱ), multiple organ failure (MOF) and the Glasgow Coma Scores (GCS) on entry and after therapy on the 3rd, 8th, and 28th day. By flow cytometery and ELISA lymphocyte subsets and cytokines were analyzed. Survival analysis was determined by the Kaplan-Meier method at 28, 60, and 90 days. Results Based on comparison of the two groups, patients in Group A exhibited a better performance in organ failure scores which was noticeable soon after initiation of treatment. Patients in Group A also demonstrated a better resolution of pre-existing organ failures during the observation period. After initiation of treatment, significant improvements in the CD4+/CD8+ ratio, a quicker balance between proinflammatory mediators such as tumor necrosis factor a, interleukin 6 and anti-inflammatory cytokines including interleukin 4 and interleukin 10 were found. This was followed by cumulative survival increases of 17.3% at 28 days, 28.9% at 60 days, and 31.4% at 90 days in Group A. The reduction in mortality was accompanied by a considerably shorter stay in the ICU and a shorter length of supportive

A prospective randomized comparison of curved array and radial echoendoscopy in patients with esophageal cancer

DEFF Research Database (Denmark)

Siemsen, Mette; Svendsen, Lars Bo; Knigge, Ulrich

2003-01-01

BACKGROUND: Both curved array and radial scanning echoendoscopy are used for locoregional staging of cancer arising in the esophagus or cardia. The accuracy of TNM staging of these malignancies by curved array and radial EUS was compared in a prospective, randomized study. METHODS: Patients...... with cancer of the esophagus or cardia were examined by both curved array and radial echoendoscopy in randomized order by the same endosonographer in an unblinded fashion. The staging results and the examination time for the two echoendoscopies were compared and statistically analyzed, and finally compared......, respectively, 15 and 12 minutes (pcancer of the esophagus or cardia. The choice of echoendoscope for TNM staging in patients with these malignancies is, therefore, a question...

Endoscopic procedure with a modified Reiki intervention: a pilot study.

Science.gov (United States)

Hulse, Rosalinda S; Stuart-Shor, Eileen M; Russo, Jonathan

2010-01-01

This pilot study examined the use of Reiki prior to colonoscopy to reduce anxiety and minimize intraprocedure medications compared with usual care. A prospective, nonblinded, partially randomized patient preference design was employed using 21 subjects undergoing colonoscopy for the first time. Symptoms of anxiety and pain were assessed using a Likert-type scale. Between-group differences were assessed using chi-square analyses and analysis of variance. There were no differences between the control (n = 10) and experimental (n = 11) groups on age (mean = 58 years, SD = 8.5) and gender (53% women). The experimental group had higher anxiety (4.5 vs. 2.6, p = .03) and pain (0.8 vs. 0.2, p = .42) scores prior to colonoscopy. The Reiki intervention reduced mean heart rate (-9 beats/minute), systolic blood pressure (-10 mmHg), diastolic blood pressure (-4 mmHg), and respirations (-3 breaths/minute). There were no between-group differences on intraprocedure medication use or postprocedure physiologic measures. Although the experimental group patients had more symptoms, they did not require additional pain medication during the procedure, suggesting that (1) anxious people may benefit from an adjunctive therapy; (2) anxiety and pain are decreased by Reiki therapy for patients undergoing colonoscopy, and (3) additional intraprocedure pain medication may not be needed for colonoscopy patients receiving Reiki therapy. This pilot study provided important insights in preparation for a rigorous, randomized, controlled clinical trial.

Using Brothel Leadership to Improve Condom Use among Brothel-based Female Sex Workers in Abuja, Nigeria : Results of a Cluster Randomized Pilot Study

NARCIS (Netherlands)

Okafor, Uchenna O.; Crutzen, Rik; Sylvia, Adebajo; Ifeanyi, Okekearu; Van Den Borne, Bart

2017-01-01

Support by brothel leaders and the promotion of a conducive environment for HIV prevention programs within brothel establishments are important to promote a safe working environment for Brothel-Based Female Sex Workers (BB FSWs). This study assesses the effects of a cluster randomized pilot trial

Immediate loading versus immediate provisionalization of maxillary single-tooth replacements: a prospective randomized study with BioComp implants

NARCIS (Netherlands)

Lindeboom, Jerome A.; Frenken, Joost W.; Dubois, Leander; Frank, Michael; Abbink, Ingmar; Kroon, Frans H.

2006-01-01

PURPOSE: The aim of this prospective randomized study was to evaluate the clinical outcome of immediately loaded solid plasma sprayed (TPS) BioComp (BioComp Industries BV, Vught, The Netherlands) implants versus immediate provisionalized but non-loaded BioComp implants in the anterior and premolar

Providing Home-Based HIV Testing and Counseling for Transgender Youth (Project Moxie): Protocol for a Pilot Randomized Controlled Trial.

Science.gov (United States)

Stephenson, Rob; Metheny, Nicholas; Sharma, Akshay; Sullivan, Stephen; Riley, Erin

2017-11-28

Transgender and gender nonconforming people experience some of the highest human immunodeficiency virus (HIV) rates in the United States, and experience many structural and behavioral barriers that may limit their engagement in HIV testing, prevention, and care. Evidence suggests that transgender and gender nonconforming youth (TY) are especially vulnerable to acquiring HIV, yet there is little research on TY and few services are targeted towards HIV testing, prevention, and care for this population. Telehealth presents an opportunity to mitigate some structural barriers that TY experience in accessing HIV testing, allowing TY to engage in HIV testing and counseling in a safe and nonjudgmental space of their choosing. Project Moxie is an HIV prevention intervention that pairs the use of HIV self-testing with remote video-based counseling and support from a trained, gender-affirming counselor. This study aims to offer a more positive HIV testing and counseling experience, with the goal of improving HIV testing frequency. Project Moxie involves a pilot randomized controlled trial (RCT) of 200 TY aged 15-24 years, who are randomized on a 1:1 basis to control or intervention arms. The aim is to examine whether the addition of counseling provided via telehealth, coupled with home-based HIV testing, can create gains in routine HIV testing among TY over a six-month follow-up period. This study implements a prospective pilot RCT of 200 TY recruited online. Participants in the control arm will receive one HIV self-testing kit and will be asked to report their results via the study's website. Participants in the experimental arm will receive one HIV self-testing kit and will test with a remotely-located counselor during a prescheduled video-counseling session. Participants are assessed at baseline, and at three and six months posttesting. Project Moxie was launched in June 2017 and recruitment is ongoing. As of August 21, 2017, the study had enrolled 130 eligible

Problem-solving skills training for parents of children with chronic pain: a pilot randomized controlled trial.

Science.gov (United States)

Palermo, Tonya M; Law, Emily F; Bromberg, Maggie; Fales, Jessica; Eccleston, Christopher; Wilson, Anna C

2016-06-01

This pilot randomized controlled trial aimed to determine the feasibility, acceptability, and preliminary efficacy of parental problem-solving skills training (PSST) compared with treatment as usual on improving parental mental health symptoms, physical health and well-being, and parenting behaviors. Effects of parent PSST on child outcomes (pain, emotional, and physical functioning) were also examined. Participants included 61 parents of children aged 10 to 17 years with chronic pain randomized to PSST (n = 31) or treatment as usual (n = 30) groups. Parents receiving PSST participated in 4 to 6 individual sessions of training in problem-solving skills. Outcomes were assessed at pretreatment, immediately after treatment, and at a 3-month follow-up. Feasibility was determined by therapy session attendance, therapist ratings, and parent treatment acceptability ratings. Feasibility of PSST delivery in this population was demonstrated by high compliance with therapy attendance, excellent retention, high therapist ratings of treatment engagement, and high parent ratings of treatment acceptability. PSST was associated with posttreatment improvements in parental depression (d = -0.68), general mental health (d = 0.64), and pain catastrophizing (d = -0.48), as well as in child depression (d = -0.49), child general anxiety (d = -0.56), and child pain-specific anxiety (d = -0.82). Several effects were maintained at the 3-month follow-up. Findings demonstrate that PSST is feasible and acceptable to parents of youths with chronic pain. Treatment outcome analyses show promising but mixed patterns of effects of PSST on parent and child mental health outcomes. Further rigorous trials of PSST are needed to extend these pilot results.

Processing speed and working memory training in multiple sclerosis: a double-blind randomized controlled pilot study.

Science.gov (United States)

Hancock, Laura M; Bruce, Jared M; Bruce, Amanda S; Lynch, Sharon G

2015-01-01

Between 40-65% of multiple sclerosis patients experience cognitive deficits, with processing speed and working memory most commonly affected. This pilot study investigated the effect of computerized cognitive training focused on improving processing speed and working memory. Participants were randomized into either an active or a sham training group and engaged in six weeks of training. The active training group improved on a measure of processing speed and attention following cognitive training, and data trended toward significance on measures of other domains. Results provide preliminary evidence that cognitive training with multiple sclerosis patients may produce moderate improvement in select areas of cognitive functioning.

Provider Training to Screen and Initiate Evidence-Based Pediatric Obesity Treatment in Routine Practice Settings: A Randomized Pilot Trial.

Science.gov (United States)

Kolko, Rachel P; Kass, Andrea E; Hayes, Jacqueline F; Levine, Michele D; Garbutt, Jane M; Proctor, Enola K; Wilfley, Denise E

This randomized pilot trial evaluated two training modalities for first-line, evidence-based pediatric obesity services (screening and goal setting) among nursing students. Participants (N = 63) were randomized to live interactive training or Web-facilitated self-study training. Pretraining, post-training, and 1-month follow-up assessments evaluated training feasibility, acceptability, and impact (knowledge and skill via simulation). Moderator (previous experience) and predictor (content engagement) analyses were conducted. Nearly all participants (98%) completed assessments. Both types of training were acceptable, with higher ratings for live training and participants with previous experience (ps pediatric obesity services. Copyright © 2016 National Association of Pediatric Nurse Practitioners. Published by Elsevier Inc. All rights reserved.

Selective decontamination in pediatric liver transplants. A randomized prospective study.

Science.gov (United States)

Smith, S D; Jackson, R J; Hannakan, C J; Wadowsky, R M; Tzakis, A G; Rowe, M I

1993-06-01

Although it has been suggested that selective decontamination of the digestive tract (SDD) decreases postoperative aerobic Gram-negative and fungal infections in orthotopic liver transplantation (OLT), no controlled trials exist in pediatric patients. This prospective, randomized controlled study of 36 pediatric OLT patients examines the effect of short-term SDD on postoperative infection and digestive tract flora. Patients were randomized into two groups. The control group received perioperative parenteral antibiotics only. The SDD group received in addition polymyxin E, tobramycin, and amphotericin B enterally and by oropharyngeal swab postoperatively until oral intake was tolerated (6 +/- 4 days). Indications for operation, preoperative status, age, and intensive care unit and hospital length of stay were no different in SDD (n = 18) and control (n = 18) groups. A total of 14 Gram-negative infections (intraabdominal abscess 7, septicemia 5, pneumonia 1, urinary tract 1) developed in the 36 patients studied. Mortality was not significantly different in the two groups. However, there were significantly fewer patients with Gram-negative infections in the SDD group: 3/18 patients (11%) vs. 11/18 patients (50%) in the control group, P < 0.001. There was also significant reduction in aerobic Gram-negative flora in the stool and pharynx in patients receiving SDD. Gram-positive and anaerobic organisms were unaffected. We conclude that short-term postoperative SDD significantly reduces Gram-negative infections in pediatric OLT patients.

Protocol for the Osteoporosis Choice trial. A pilot randomized trial of a decision aid in primary care practice

Directory of Open Access Journals (Sweden)

Tulledge-Scheitel Sidna M

2009-12-01

Full Text Available Abstract Background Bisphosphonates can reduce fracture risk in patients with osteoporosis, but many at-risk patients do not start or adhere to these medications. The aims of this study are to: (1 preliminarily evaluate the effect of an individualized 10-year osteoporotic fracture risk calculator and decision aid (OSTEOPOROSIS CHOICE for postmenopausal women at risk for osteoporotic fractures; and (2 assess the feasibility and validity (i.e., absence of contamination of patient-level randomization (vs. cluster randomization in pilot trials of decision aid efficacy. Methods/Design This is a protocol for a parallel, 2-arm, randomized trial to compare an intervention group receiving OSTEOPOROSIS CHOICE to a control group receiving usual primary care. Postmenopausal women with bone mineral density T-scores of STEOPOROSIS CHOICE on five outcomes: (a patient knowledge regarding osteoporosis risk factors and treatment; (b quality of the decision-making process for both the patient and clinician; (c patient and clinician acceptability and satisfaction with the decision aid; (d rate of bisphosphonate use and adherence, and (e trial processes (e.g., ability to recruit participants, collect patient outcomes. To capture these outcomes, we will use patient and clinician surveys following each visit and video recordings of the clinical encounters. These video recordings will also allow us to determine the extent to which clinicians previously exposed to the decision aid were able to recreate elements of the decision aid with control patients (i.e., contamination. Pharmacy prescription profiles and follow-up phone interviews will assess medication start and adherence at 6 months. Discussion This pilot trial will provide evidence of feasibility, validity of patient randomization, and preliminary efficacy of a novel approach -- decision aids -- to improving medication adherence for postmenopausal women at risk of osteoporotic fractures. The results will inform

Pylorus preserving pancreaticoduodenectomy versus standard Whipple procedure: a prospective, randomized, multicenter analysis of 170 patients with pancreatic and periampullary tumors

NARCIS (Netherlands)

K.T. Tran; H.G. Smeenk; C.H.J. van Eijck (Casper); G. Kazemier (Geert); W.C.J. Hop (Wim); J.W. Greve (Jan Willem); O.T. Terpstra (Onno); J.A. Zijlstra (Jan); P. Klinkert; J. Jeekel (Hans)

2004-01-01

textabstractOBJECTIVE: A prospective randomized multicenter study was performed to assess whether the results of pylorus-preserving pancreaticoduodenectomy (PPPD) equal those of the standard Whipple (SW) operation, especially with respect to duration of surgery, blood loss,

Topical silver sulfadiazine vs collagenase ointment for the treatment of partial thickness burns in children: a prospective randomized trial.

Science.gov (United States)

Ostlie, Daniel J; Juang, David; Aguayo, Pablo; Pettiford-Cunningham, Janine P; Erkmann, Erin A; Rash, Diane E; Sharp, Susan W; Sharp, Ronald J; St Peter, Shawn D

2012-06-01

The 2 most commonly used topical agents for partial thickness burns are silver sulfadiazine (SSD) and collagenase ointment (CO). Silver sulfadiazine holds antibacterial properties, and eschar separation occurs naturally. Collagenase ointment is an enzyme that cleaves denatured collagen facilitating separation but has no antibacterial properties. Currently, there are no prospective comparative data in children for these 2 agents. Therefore, we conducted a prospective randomized trial. After institutional review board approval, patients were randomized to daily debridement with SSD or CO. Primary outcome was the need for skin grafting. Patients were treated for 2 days with SSD with subsequent randomization. Polymyxin was mixed with CO for antibacterial coverage. Debridements were performed daily for 10 days or until the burn healed. Grafting was performed after 10 days if not healed. From January 2008 to January 2011, 100 patients were enrolled, with no differences in patient characteristics. There were no differences in clinical course, outcome, or need for skin grafting. Wound infections occurred in 7 patients treated with CO and 1 patient treated with SSD (P = .06). Collagenase ointment was more expensive than SSD (P burns results. Copyright © 2012 Elsevier Inc. All rights reserved.

Treatment of benign esophageal stricture by Eder-Puestow or balloon dilators: a comparison between randomized and prospective nonrandomized trials.

Science.gov (United States)

Yamamoto, H; Hughes, R W; Schroeder, K W; Viggiano, T R; DiMagno, E P

1992-03-01

To determine whether the natural history of strictures is affected by the type of dilator used to treat newly diagnosed peptic strictures, we designed a prospective randomized trial to compare the results after Eder-Puestow or Medi-Tech balloon dilation. We entered 31 patients into the trial. We also prospectively followed up all 92 nonrandomized patients who underwent their first dilation for a benign stricture during the same period as the prospective randomized trial. The nonrandomized patients also underwent dilation with either the Eder-Puestow or the balloon technique at the discretion of the gastroenterologist performing the endoscopy. We found no statistically significant differences in the immediate or long-term results of the two methods among the randomized, nonrandomized, and overall combined groups. All but 1 of the 123 patients had immediate relief of dysphagia. Within each group of patients, the probability of remaining free of dysphagia 1 year after the initial dilation was approximately 20%, and the probability of not requiring a second dilation was approximately 65% with either technique. Major (esophageal rupture) and minor (bleeding or chest pain) complications occurred in 1% and 5% of the patients and 0.4% and 3% of the total dilation procedures, respectively. The esophageal rupture and four of six minor complications occurred after repeated dilations. Five of the six minor complications occurred with use of the Eder-Puestow dilators. We conclude that Eder-Puestow and balloon dilations of benign esophageal strictures are associated with similar outcomes, but repeated dilations and the Eder-Puestow technique may be associated with an increased risk of complications.

A prospective randomized single blind trial of Fleet phosphate enema versus glycerin suppositories as preparation for flexible sigmoidoscopy.

Science.gov (United States)

Underwood, D; Makar, R R; Gidwani, A L; Najfi, S M; Neilly, P; Gilliland, R

2010-03-01

This study compared the efficacy and patient acceptability of two methods of bowel preparation for flexible sigmoidoscopy. Patients attending for outpatient flexible sigmoidoscopy were prospectively randomized to receive one Fleet ready-to-use enema or 2 x 4 g glycerin suppositories, 2 h preprocedure. Patient and endoscopist questionnaires were used to compare the outcomes. From November 2000 to August 2001, 203 (male = 95; female = 108) patients were randomized. Patient data available for 163 patients (enema = 93; suppository = 70) revealed: ease of use (enema = 52; suppository = 25; P suppositories.

Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial.

Science.gov (United States)

Petrella, Robert J; Gill, Dawn P; Zou, Guangyong; DE Cruz, Ashleigh; Riggin, Brendan; Bartol, Cassandra; Danylchuk, Karen; Hunt, Kate; Wyke, Sally; Gray, Cindy M; Bunn, Christopher; Zwarenstein, Merrick

2017-12-01

Hockey Fans in Training (Hockey FIT) is a gender-sensitized weight loss and healthy lifestyle program. We investigated 1) feasibility of recruiting and retaining overweight and obese men into a pilot pragmatic randomized controlled trial and 2) potential for Hockey FIT to lead to weight loss and improvements in other outcomes at 12 wk and 12 months. Male fans of two ice hockey teams (35-65 yr; body mass index ≥28 kg·m) located in Ontario (Canada) were randomized to intervention (Hockey FIT) or comparator (wait-list control). Hockey FIT includes a 12-wk active phase (weekly, coach-led group meetings including provision of dietary information, practice of behavior change techniques, and safe exercise sessions plus incremental pedometer walking) and a 40-wk minimally supported phase (smartphone app for sustaining physical activity, private online social network, standardized e-mails, booster session/reunion). Measurement at baseline and 12 wk (both groups) and 12 months (intervention group only) included clinical outcomes (e.g., weight) and self-reported physical activity, diet, and self-rated health. Eighty men were recruited in 4 wk; trial retention was >80% at 12 wk and >75% at 12 months. At 12 wk, the intervention group lost 3.6 kg (95% confidence interval, -5.26 to -1.90 kg) more than the comparator group (P < 0.001) and maintained this weight loss to 12 months. The intervention group also demonstrated greater improvements in other clinical measures, physical activity, diet, and self-rated health at 12 wk; most sustained to 12 months. Results suggest feasible recruitment/retention of overweight and obese men in the Hockey FIT program. Results provide evidence for the potential effectiveness of Hockey FIT for weight loss and improved health in at-risk men and, thus, evidence to proceed with a definitive trial.

Problem Solving Skills Training for Parents of Children with Chronic Pain: A Pilot Randomized Controlled Trial

Science.gov (United States)

Palermo, Tonya M.; Law, Emily F.; Bromberg, Maggie; Fales, Jessica; Eccleston, Christopher; Wilson, Anna C.

2016-01-01

This pilot randomized controlled trial aimed to determine the feasibility, acceptability, and preliminary efficacy of parental problem solving skills training (PSST) compared to treatment as usual (TAU) on improving parental mental health symptoms, physical health and well-being, and parenting behaviors. Effects of parent PSST on child outcomes (pain, emotional and physical functioning) were also examined. Participants included 61 parents of children aged 10–17 years with chronic pain randomized to PSST (n = 31) or TAU (n = 30). Parents receiving PSST participated in 4–6 individual sessions of training in problem solving skills. Outcomes were assessed at pre-treatment, immediately post-treatment, and at 3-month follow up. Feasibility was determined by therapy session attendance, therapist ratings, and parent treatment acceptability ratings. Feasibility of PSST delivery in this population was demonstrated by high compliance with therapy attendance, excellent retention, high therapist ratings of treatment engagement, and high parent ratings of treatment acceptability. PSST was associated with post-treatment improvements in parental depression (d = −0.68), general mental health (d = 0.64), and pain catastrophizing (d = −0.48), as well as in child depression (d = −0.49), child general anxiety (d = −0.56), and child pain-specific anxiety (d = −0.82). Several effects were maintained at 3-month follow-up. Findings demonstrate that PSST is feasible and acceptable to parents of youth with chronic pain. Treatment outcome analyses show promising but mixed patterns of effects of PSST on parent and child mental health outcomes. Further rigorous trials of PSST are needed to extend these pilot results. PMID:26845525

Prospective randomized controlled trial of an injectable esophageal prosthesis versus a sham procedure for endoscopic treatment of gastroesophageal reflux disease

NARCIS (Netherlands)

Fockens, P.; Cohen, L.; Edmundowicz, S.A.; Binmoeller, K.; Rothstein, R.I.; Smith, D.; Lin, E.; Nickl, N.; Overholt, B.; Kahrilas, P.J.; Vakil, N.; Abdel Aziz Hassan, A.M.; Lehman, G.A.

2010-01-01

This study aimed to assess whether endoscopic implantation of an injectable esophageal prosthesis, the Gatekeeper Reflux Repair System (GK), is a safe and effective therapy for controlling gastroesophageal reflux disease (GERD). A prospective, randomized, sham-controlled, single-blinded,

Perfusion-CT guided intravenous thrombolysis in patients with unknown-onset stroke: a randomized, double-blind, placebo-controlled, pilot feasibility trial.

Science.gov (United States)

Michel, Patrik; Ntaios, George; Reichhart, Marc; Schindler, Christian; Bogousslavsky, Julien; Maeder, Philip; Meuli, Reto; Wintermark, Max

2012-06-01

Patients with unknown stroke onset are generally excluded from acute recanalisation treatments. We designed a pilot study to assess feasibility of a trial of perfusion computed tomography (PCT)-guided thrombolysis in patients with ischemic tissue at risk of infarction and unknown stroke onset. Patients with a supratentorial stroke of unknown onset in the middle cerebral artery territory and significant volume of at-risk tissue on PCT were randomized to intravenous thrombolysis with alteplase (0.9 mg/kg) or placebo. Feasibility endpoints were randomization and blinded treatment of patients within 2 h after hospital arrival, and the correct application (estimation) of the perfusion imaging criteria. At baseline, there was a trend towards older age [69.5 (57-78) vs. 49 (44-78) years] in the thrombolysis group (n = 6) compared to placebo (n = 6). Regarding feasibility, hospital arrival to treatment delay was above the allowed 2 h in three patients (25%). There were two protocol violations (17%) regarding PCT, both underestimating the predicted infarct in patients randomized in the placebo group. No symptomatic hemorrhage or death occurred during the first 7 days. Three of the four (75%) and one of the five (20%) patients were recanalized in the thrombolysis and placebo group respectively. The volume of non-infarcted at-risk tissue was 84 (44-206) cm(3) in the treatment arm and 29 (8-105) cm(3) in the placebo arm. This pilot study shows that a randomized PCT-guided thrombolysis trial in patients with stroke of unknown onset may be feasible if issues such as treatment delays and reliable identification of tissue at risk of infarction tissue are resolved. Safety and efficiency of such an approach need to be established.

Perfusion-CT guided intravenous thrombolysis in patients with unknown-onset stroke: a randomized, double-blind, placebo-controlled, pilot feasibility trial

International Nuclear Information System (INIS)

Michel, Patrik; Ntaios, George; Reichhart, Marc; Schindler, Christian; Bogousslavsky, Julien; Maeder, Philip; Meuli, Reto; Wintermark, Max

2012-01-01

Patients with unknown stroke onset are generally excluded from acute recanalisation treatments. We designed a pilot study to assess feasibility of a trial of perfusion computed tomography (PCT)-guided thrombolysis in patients with ischemic tissue at risk of infarction and unknown stroke onset. Patients with a supratentorial stroke of unknown onset in the middle cerebral artery territory and significant volume of at-risk tissue on PCT were randomized to intravenous thrombolysis with alteplase (0.9 mg/kg) or placebo. Feasibility endpoints were randomization and blinded treatment of patients within 2 h after hospital arrival, and the correct application (estimation) of the perfusion imaging criteria. At baseline, there was a trend towards older age [69.5 (57-78) vs. 49 (44-78) years] in the thrombolysis group (n = 6) compared to placebo (n = 6). Regarding feasibility, hospital arrival to treatment delay was above the allowed 2 h in three patients (25%). There were two protocol violations (17%) regarding PCT, both underestimating the predicted infarct in patients randomized in the placebo group. No symptomatic hemorrhage or death occurred during the first 7 days. Three of the four (75%) and one of the five (20%) patients were recanalized in the thrombolysis and placebo group respectively. The volume of non-infarcted at-risk tissue was 84 (44-206) cm 3 in the treatment arm and 29 (8-105) cm 3 in the placebo arm. This pilot study shows that a randomized PCT-guided thrombolysis trial in patients with stroke of unknown onset may be feasible if issues such as treatment delays and reliable identification of tissue at risk of infarction tissue are resolved. Safety and efficiency of such an approach need to be established. (orig.)

Mixed methods evaluation of a randomized control pilot trial targeting sugar-sweetened beverage behaviors.

Science.gov (United States)

Zoellner, Jamie; Cook, Emily; Chen, Yvonnes; You, Wen; Davy, Brenda; Estabrooks, Paul

2013-02-01

This Excessive sugar-sweetened beverage (SSB) consumption and low health literacy skills have emerged as two public health concerns in the United States (US); however, there is limited research on how to effectively address these issues among adults. As guided by health literacy concepts and the Theory of Planned Behavior (TPB), this randomized controlled pilot trial applied the RE-AIM framework and a mixed methods approach to examine a sugar-sweetened beverage (SSB) intervention (SipSmartER), as compared to a matched-contact control intervention targeting physical activity (MoveMore). Both 5-week interventions included two interactive group sessions and three support telephone calls. Executing a patient-centered developmental process, the primary aim of this paper was to evaluate patient feedback on intervention content and structure. The secondary aim was to understand the potential reach (i.e., proportion enrolled, representativeness) and effectiveness (i.e. health behaviors, theorized mediating variables, quality of life) of SipSmartER. Twenty-five participants were randomized to SipSmartER (n=14) or MoveMore (n=11). Participants' intervention feedback was positive, ranging from 4.2-5.0 on a 5-point scale. Qualitative assessments reavealed several opportunties to improve clarity of learning materials, enhance instructions and communication, and refine research protocols. Although SSB consumption decreased more among the SipSmartER participants (-256.9 ± 622.6 kcals), there were no significant group differences when compared to control participants (-199.7 ± 404.6 kcals). Across both groups, there were significant improvements for SSB attitudes, SSB behavioral intentions, and two media literacy constructs. The value of using a patient-centered approach in the developmental phases of this intervention was apparent, and pilot findings suggest decreased SSB may be achieved through targeted health literacy and TPB strategies. Future efforts are needed to examine

Determination of flow-rate characteristics and parameters of piezo pilot valves

Directory of Open Access Journals (Sweden)

Takosoglu Jakub

2017-01-01

Full Text Available Pneumatic directional valves are used in most industrial pneumatic systems. Most of them are two-stage valves controlled by a pilot valve. Pilot valves are often chosen randomly. Experimental studies in order to determine the flow-rate characteristics and parameters of pilot valves were not conducted. The paper presents experimental research of two piezo pilot valves.

Creative music therapy to promote brain structure, function, and neurobehavioral outcomes in preterm infants: a randomized controlled pilot trial protocol.

Science.gov (United States)

Haslbeck, Friederike Barbara; Bucher, Hans-Ulrich; Bassler, Dirk; Hagmann, Cornelia

2017-01-01

Preterm birth is associated with increased risk of neurological impairment and deficits in cognition, motor function, and behavioral problems. Limited studies indicate that multi-sensory experiences support brain development in preterm infants. Music appears to promote neurobiological processes and neuronal learning in the human brain. Creative music therapy (CMT) is an individualized, interactive therapeutic approach based on the theory and methods of Nordoff and Robbins. CMT may promote brain development in preterm infants via concurrent interaction and meaningful auditory stimulation. We hypothesize that preterm infants who receive creative music therapy during neonatal intensive care admission will have developmental benefits short- and long-term brain function. A prospective, randomized controlled single-center pilot trial involving 60 clinically stable preterm infants under 32 weeks of gestational age is conducted in preparation for a multi-center trial. Thirty infants each are randomized to either standard neonatal intensive care or standard care with CMT. Music therapy intervention is approximately 20 min in duration three times per week. A trained music therapist sings for the infants in lullaby style, individually entrained and adjusted to the infant's rhythm and affect. Primary objectives of this study are feasibility of protocol implementation and investigating the potential mechanism of efficacy for this new intervention. To examine the effect of this new intervention, non-invasive, quantitative magnetic resonance imaging (MRI) methods at corrected age and standardized neurodevelopmental assessments using the Bayley Scales of Infant and Toddler Development third edition at a corrected age of 24 months and Kaufman Assessment Battery for Children at 5 years will be performed. All assessments will be performed and analyzed by blinded experts. To our knowledge, this is the first randomized controlled clinical trial to systematically examine possible

Using pilot data to size a two-arm randomized trial to find a nearly optimal personalized treatment strategy.

Science.gov (United States)

Laber, Eric B; Zhao, Ying-Qi; Regh, Todd; Davidian, Marie; Tsiatis, Anastasios; Stanford, Joseph B; Zeng, Donglin; Song, Rui; Kosorok, Michael R

2016-04-15

A personalized treatment strategy formalizes evidence-based treatment selection by mapping patient information to a recommended treatment. Personalized treatment strategies can produce better patient outcomes while reducing cost and treatment burden. Thus, among clinical and intervention scientists, there is a growing interest in conducting randomized clinical trials when one of the primary aims is estimation of a personalized treatment strategy. However, at present, there are no appropriate sample size formulae to assist in the design of such a trial. Furthermore, because the sampling distribution of the estimated outcome under an estimated optimal treatment strategy can be highly sensitive to small perturbations in the underlying generative model, sample size calculations based on standard (uncorrected) asymptotic approximations or computer simulations may not be reliable. We offer a simple and robust method for powering a single stage, two-armed randomized clinical trial when the primary aim is estimating the optimal single stage personalized treatment strategy. The proposed method is based on inverting a plugin projection confidence interval and is thereby regular and robust to small perturbations of the underlying generative model. The proposed method requires elicitation of two clinically meaningful parameters from clinical scientists and uses data from a small pilot study to estimate nuisance parameters, which are not easily elicited. The method performs well in simulated experiments and is illustrated using data from a pilot study of time to conception and fertility awareness. Copyright © 2015 John Wiley & Sons, Ltd.

The clinical outcome and microbiological profile of bone-anchored hearing systems (BAHS) with different abutment topographies: a prospective pilot study.

Science.gov (United States)

Trobos, Margarita; Johansson, Martin Lars; Jonhede, Sofia; Peters, Hanna; Hoffman, Maria; Omar, Omar; Thomsen, Peter; Hultcrantz, Malou

2018-06-01

In this prospective clinical pilot study, abutments with different topologies (machined versus polished) were compared with respect to the clinical outcome and the microbiological profile. Furthermore, three different sampling methods (retrieval of abutment, collection of peri-abutment exudate using paper-points, and a small peri-abutment soft-tissue biopsy) were evaluated for the identification and quantification of colonising bacteria. Twelve patients, seven with machined abutment and five with polished abutment, were included in the analysis. Three different sampling procedures were employed for the identification and quantification of colonising bacteria from baseline up to 12 months, using quantitative culturing. Clinical outcome measures (Holgers score, hygiene, pain, numbness and implant stability) were investigated. The clinical parameters, and total viable bacteria per abutment or in tissue biopsies did not differ significantly between the polished and machined abutments. The total CFU/mm 2 abutment and CFU/peri-abutment fluid space of anaerobes, aerobes and staphylococci were significantly higher for the polished abutment. Anaerobic bacteria were detected in the tissue biopsies before BAHS implantation. Anaerobes and Staphylococcus spp. were detected in all three compartments after BAHS installation. For most patients (10/12), the same staphylococcal species were found in at least two of the three compartments at the same time-point. The common skin coloniser Staphylococcus epidermidis was identified in all patients but one (11/12), whereas the pathogen Staphylococcus aureus was isolated in five of the patients. Several associations between clinical and microbiological parameters were found. There was no difference in the clinical outcome with the use of polished versus machined abutment at 3 and 12 months after implantation. The present pilot trial largely confirmed a suitable study design, sampling and analytical methodology to determine the effects

Determining the impact of a new physiotherapist-led primary care model for back pain: protocol for a pilot cluster randomized controlled trial.

Science.gov (United States)

Miller, Jordan; Barber, David; Donnelly, Catherine; French, Simon; Green, Michael; Hill, Jonathan; MacDermid, Joy; Marsh, Jacquelyn; Norman, Kathleen; Richardson, Julie; Taljaard, Monica; Wideman, Timothy; Cooper, Lynn; McPhee, Colleen

2017-11-09

Back pain is a leading contributor to disability, healthcare costs, and lost work. Family physicians are the most common first point of contact in the healthcare system for people with back pain, but physiotherapists (PTs) may be able to support the primary care team through evidence-based primary care. A cluster randomized trial is needed to determine the clinical, health system, and societal impact of a primary care model that integrates physiotherapists at the first visit for people with back pain. Prior to conducting a future fully powered cluster randomized trial, we need to demonstrate feasibility of the methods. Therefore, the purpose of this pilot study will be to: 1) Determine feasibility of patient recruitment, assessment procedures, and retention. 2) Determine the feasibility of training and implementation of a new PT-led primary care model for low back pain (LBP) 3) Explore the perspectives of patients and healthcare providers (HCPs) related to their experiences and attitudes towards the new service delivery model, barriers/facilitators to implementation, perceived satisfaction, perceived value, and impact on clinic processes and patient outcomes. This pilot cluster randomized controlled trial will enroll four sites and randomize them to implement a new PT-led primary care model for back pain or a usual physician-led primary care model. All adults booking a primary care visit for back pain will be invited to participate. Feasibility outcomes will include: recruitment and retention rates, completeness of assessment data, PT training participation and confidence after training, and PT treatment fidelity. Secondary outcomes will include the clinical, health system, cost, and process outcomes planned for the future fully powered cluster trial. Results will be analyzed and reported descriptively and qualitatively. To explore perspectives of both HCPs and patients, we will conduct semi-structured qualitative interviews with patients and focus groups with HCPs

Is ginger effective for the treatment of irritable bowel syndrome? A double blind randomized controlled pilot trial.

Science.gov (United States)

van Tilburg, Miranda A L; Palsson, Olafur S; Ringel, Yehuda; Whitehead, William E

2014-02-01

Ginger is one of the most commonly used herbal medicines for irritable bowel syndrome (IBS) but no data exists about its effectiveness. Double blind randomized controlled trial. University of North Carolina, Chapel Hill, North Carolina, USA. Forty-five IBS patients were randomly assigned to three groups: placebo, 1g of ginger, and 2g of ginger daily for 28 days. The IBS severity scale (IBS-SS) was administered, as well as adequate relief of symptoms scale. A responder was defined as having at least 25% reduction in IBS-SS post-treatment. There were 57.1% responders to placebo, 46.7% to 1g and 33.3% to 2g of ginger. Adequate relief was reported by 53.3% on placebo and 53.3% in both ginger groups combined. Side effects were mild and reported by 35.7% in the placebo and 16.7% in the ginger groups. This double blind randomized controlled pilot study suggests ginger is well tolerated but did not perform better than placebo. Larger trials are needed before any definitive conclusions can be drawn. Copyright © 2014 Elsevier Ltd. All rights reserved.

Comparison of a trifocal intraocular lens with a+3.0 D bifocal IOL: results of a prospective randomized clinical trial

NARCIS (Netherlands)

Jonker, S.M.R.; Bauer, N.J.C.; Makhotkina, N.Y.; Berendschot, T.T.J.M.; van den Biggelaar, F.J.H.M.; Nuijts, R.M.M.A.

Purpose To compare visual outcomes in patients with cataract surgery and bilateral implantation of a trifocal or bifocal intraocular lens (IOL). Setting University Eye Clinic Maastricht, the Netherlands. Design Prospective randomized clinical trial. Methods Eyes with cataract and less than 1.0

A six-year prospective randomized study of a nano-hybrid and a conventional hybrid resin composite in Class II restorations

DEFF Research Database (Denmark)

van Dijken, Jan W V; Pallesen, Ulla

2013-01-01

The objective of this 6 year prospective randomized equivalence trial was to evaluate the long-term clinical performance of a new nano-hybrid resin composite (RC) in Class II restorations in an intraindividual comparison with its well-established conventional hybrid RC predecessor....

Calcipotriol versus coal tar: a prospective randomized study in stable plaque psoriasis

Energy Technology Data Exchange (ETDEWEB)

Sharma, V.; Kaur, I.; Kumar, B. [Postgraduate Institute of Medicinal Education & Research, Chandigarh (India)

2003-10-01

Topical therapies are the first line of treatment for patients with stable plaque psoriasis (SPP) affecting a limited body surface area. Very few trials comparing newer agents, such as 0.005% topical calcipotriol, with conventional modes of therapy, such as coal tar ointment, have been reported. A prospective, right-left randomized, investigator-blinded study with a 12-week treatment period and an 8-week follow-up period was performed. It was found that 0.005% calcipotriol ointment produced a faster initial response and had better cosmetic acceptability in patients, although after a long period of treatment, i.e. 12 weeks, 5% coal tar ointment had comparable efficacy. There was no statistically significant difference in the relapse rates between the two modalities.

Prospects for pilot plants based on the tokamak, spherical tokamak and stellarator

International Nuclear Information System (INIS)

Menard, J.E.; Bromberg, L.; Brown, T.; Burgess, Thomas W.; Dix, D.; Gerrity, T.; Goldston, R.J.; Hawryluk, R.; Kastner, R.; Kessel, C.; Malang, S.; Minervini, J.; Neilson, G.H.; Neumeyer, C.L.; Prager, S.; Sawan, M.; Sheffield, J.; Sternlieb, A.; Waganer, L.; Whyte, D.G.; Zarnstorff, M.C.

2011-01-01

A potentially attractive next-step towards fusion commercialization is a pilot plant, i.e. a device ultimately capable of small net electricity production in as compact a facility as possible and in a configuration scalable to a full-size power plant. A key capability for a pilot-plant programme is the production of high neutron fluence enabling fusion nuclear science and technology (FNST) research. It is found that for physics and technology assumptions between those assumed for ITER and nth-of-a-kind fusion power plant, it is possible to provide FNST-relevant neutron wall loading in pilot devices. Thus, it may be possible to utilize a single facility to perform FNST research utilizing reactor-relevant plasma, blanket, coil and auxiliary systems and maintenance schemes while also targeting net electricity production. In this paper three configurations for a pilot plant are considered: the advanced tokamak, spherical tokamak and compact stellarator. A range of configuration issues is considered including: radial build and blanket design, magnet systems, maintenance schemes, tritium consumption and self-sufficiency, physics scenarios and a brief assessment of research needs for the configurations.

Comparison of torsional and microburst longitudinal phacoemulsification: a prospective, randomized, masked clinical trial.

Science.gov (United States)

Vasavada, Abhay R; Raj, Shetal M; Patel, Udayan; Vasavada, Vaishali; Vasavada, Viraj

2010-01-01

To compare intraoperative performance and postoperative outcome of three phacoemulsification technologies in patients undergoing microcoaxial phacoemulsification through 2.2-mm corneal incisions. The prospective, randomized, single-masked study included 360 eyes randomly assigned to torsional (Infiniti Vision System; Alcon Laboratories, Fort Worth, TX), microburst with longitudinal (Infiniti), or microburst with longitudinal (Legacy Everest, Alcon Laboratories) ultrasound. Assessments included surgical clock time, fluid volume, and intraoperative complications, central corneal thickness on day 1 and months 1 and 3 postoperatively, and endothelial cell density at 3 months postoperatively. Comparisons among groups were conducted. Torsional ultrasound required significantly less surgical clock time and fluid volume than the other groups. There were no intraoperative complications. Change in central corneal thickness and endothelial cell loss was significantly lower in the torsional ultrasound group at all postoperative visits (P < .001, Kruskal-Wallis test) compared to microburst longitudinal ultrasound modalities. Torsional ultrasound demonstrated quantitatively superior intraoperative performance and showed less increase in corneal thickness and less endothelial cell loss compared to microburst longitudinal ultrasound. Copyright 2010, SLACK Incorporated.

Electrochemotherapy as treatment option for hepatocellular carcinoma, a prospective pilot study.

Science.gov (United States)

Djokic, Mihajlo; Cemazar, Maja; Popovic, Peter; Kos, Bor; Dezman, Rok; Bosnjak, Masa; Zakelj, Martina Niksic; Miklavcic, Damijan; Potrc, Stojan; Stabuc, Borut; Tomazic, Ales; Sersa, Gregor; Trotovsek, Blaz

2018-05-01

Electrochemotherapy provides non-thermal ablation of cutaneous as well as deep seated tumors. Based on positive results of the treatment of colorectal liver metastases, we conducted a prospective pilot study on hepatocellular carcinomas with the aim of testing the feasibility, safety and effectiveness of electrochemotherapy. Electrochemotherapy with bleomycin was performed on 17 hepatocellular carcinomas in 10 patients using a previously established protocol. The procedure was performed during open surgery and the patients were followed for median 20.5 months. Electrochemotherapy was feasible for all 17 lesions, and no treatment-related adverse events or major post-operative complications were observed. The median size of the treated lesions was 24 mm (range 8-41 mm), located either centrally, i.e., near the major hepatic vessels, or peripherally. The complete response rate at 3-6 months was 80% per patient and 88% per treated lesion. Electrochemotherapy of hepatocellular carcinoma proved to be a feasible and safe treatment in all 10 patients included in this study. To evaluate the effectiveness of this method, longer observation period is needed; however the results at medium observation time of 20.5 months after treatment are encouraging, in 15 out of 17 lesions complete response was obtained. Electrochemotherapy is predominantly applicable in patients with impaired liver function due to liver cirrhosis and/or with lesions where a high-risk operation is needed to achieve curative intent, given the intra/perioperative risk for high morbidity and mortality. Copyright © 2018 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Benfotiamine in the treatment of diabetic polyneuropathy--a three-week randomized, controlled pilot study (BEDIP study).

Science.gov (United States)

Haupt, E; Ledermann, H; Köpcke, W

2005-02-01

The aim of the study was to evaluate the efficacy of benfotiamine administered over three weeks (allithiamine; a lipid-soluble vitamin B1 prodrug with high bioavailability) to patients with diabetic polyneuropathy in a randomized, placebo-controlled, double-blind, two-center pilot study. Forty inpatients (23 male, 18 female, age range 18 - 70 years) with a history of type 1 or 2 diabetes and polyneuropathy of not longer than two years, were included in the study. Twenty Patients received two 50 mg benfotiamine tablets four times daily and 20 patients received placebo over the three-week study period. Two clinical units were involved with 10 patients receiving placebo and 10 patients benfotiamine in each. The neuropathy score according to Katzenwadel et al. [1987] was used to evaluate symptoms of polyneuropathy, vibration perception threshold and both the physician's and the patient's own assessment were documented. A statistically significant (p = 0.0287) improvement in the neuropathy score was observed in the group given active drug when compared to the placebo-treated controls. There was no statistically significant change observed in the tuning fork test. The most pronounced effect on complaints was a decrease in pain (p = 0.0414). More patients in the benfotiamine-treated group than in the placebo group considered their clinical condition to have improved (p = 0.052). No side effects attributable to benfotiamine were observed. The differences between the groups cannot be attributed to a change in metabolic parameters since there were no significant alterations in the HbA1 levels and blood sugar profiles. The body mass index of the two groups did not differ. This pilot investigation (BEDIP Study) has confirmed the results of two earlier randomized controlled trials and has provided further evidence for the beneficial effects of benfotiamine in patients with diabetic neuropathy.

Can Subclinical Rickets Cause SCFE? A Prospective, Pilot Study.

Science.gov (United States)

Arkader, Alexandre; Woon, Regina P; Gilsanz, Vicente

2015-01-01

Slipped capital femoral epiphysis (SCFE) is a common disorder of the growing hip; however, its etiology remains unknown. Vitamin D (25-OH) is a major regulator of bone homeostasis and calcium metabolism. Vitamin D deficiency is one of the major causes of rickets, and rickets has been associated with SCFE. Increased body mass index (BMI) has been linked to SCFE and obese children are known to have lower vitamin D levels. Therefore, we hypothesize that children who develop SCFE may have subclinical rickets predisposing them to the development of physeal disease. This was a pilot, prospective study designed to determine the relationship between vitamin D, bone, muscle, and fat in patients with SCFE. We enrolled 20 consecutive patients with idiopathic SCFE aged 9 to 14 years. Upon diagnosis, vitamin D, PTH, T4, and thyroid-stimulating hormone blood levels were obtained. A single-slice computed tomography was used to measure cortical bone density (CBD) of the femur. Demographics, BMI, and the results obtained were compared to generate a relationship between vitamin D levels and SCFE. Twenty patients were enrolled, 13 males and 7 females, at an average age of 12 years (range, 9 to 14 y), and mean BMI% was 93.9 (range, 81.3 to 99.5). There were 15 stable and 5 unstable SCFE. Overall, mean and SD values for vitamin D, 25-OH were within the normal range (43.9 ± 13.5). We found no difference in values in vitamin D between nonobese (BMI < 95%) and obese (BMI ≥ 95%) subjects (34.8 ± 16.8 vs. 51.6 ± 22.4, P = 0.144). Moreover, we found no difference in CBD between these 2 groups (1126 ± 33.1 vs. 1147 ± 41.2, P = 0.333). There was no relation between blood values of vitamin D and measures of CBD. Although obese children are known to have lower levels of vitamin D and a higher prevalence of SCFE, we found no correlation between low vitamin D and the development of SCFE in this subset of patients.

Randomized Pilot Trial of Two Modified Endotracheal Tubes To Prevent Ventilator-associated Pneumonia.

Science.gov (United States)

Deem, Steven; Yanez, David; Sissons-Ross, Laura; Broeckel, Jo Ann Elrod; Daniel, Stephen; Treggiari, Miriam

2016-01-01

Ventilator-associated pneumonia (VAP) is a prevalent and costly nosocomial infection related to instrumentation of the airway with an endotracheal tube (ETT), enabling microaspiration of contaminated secretions. Modification of the ETT design to reduce microaspiration and/or biofilm formation may play an important role in VAP prevention. However, there is insufficient evidence to provide strong recommendations regarding the use of modified ETT and unaddressed safety concerns. We performed a pilot randomized controlled trial comparing two modified ETTs designed specifically to prevent VAP, with the standard ETT, to test the feasibility of and inform planning for a large, pivotal, randomized trial. This study was conducted with institutional review board approval under exception from informed consent. We randomized in a blinded fashion patients undergoing emergency endotracheal intubation both out of and in hospital to receive one of three different ETT types: (1) a polyurethane-cuffed tube (PUC-ETT), (2) a polyurethane-cuffed tube equipped with a port for continuous aspiration of subglottic secretions (PUC-CASS-ETT), or a (3) standard polyvinylchloride-cuffed tube (PVC-ETT). In addition to investigating feasibility and safety, the study coprimary end points were tracheal bacterial colonization reaching a cfu count >10(6) cfu per milliliter and the incidence of invasively diagnosed VAP. A total of 102 subjects were randomized and met the eligibility criteria. Randomization procedures performed well and integrity of blinding at randomization was maintained. The majority of intubations occurred in the hospital setting (n = 77), and the remainder occurred out of hospital (n = 25). Compared with the PVC-ETT, there were no significant differences in tracheal colonization for PUC-ETT (odds ratio [OR], 0.98; 95% confidence interval [CI], 0.31-3.09) or for PUC-CASS-ETT (OR, 1.26; 95% CI, 0.42-3.76). There were no differences in the risk of invasively diagnosed VAP

A Pilot Randomized Controlled Trial of an Intervention to Promote Psychological Well-Being in Critically Ill Children: Soothing Through Touch, Reading, and Music.

Science.gov (United States)

Rennick, Janet E; Stremler, Robyn; Horwood, Linda; Aita, Marilyn; Lavoie, Tanya; Majnemer, Annette; Antonacci, Marie; Knox, Alyssa; Constantin, Evelyn

2018-04-13

To examine the feasibility and acceptability of a PICU Soothing intervention using touch, reading, and music. Nonblinded, pilot randomized controlled trial. The PICU and medical-surgical wards of one Canadian pediatric hospital. Twenty PICU patients age 2-14 years old and their parents, randomized to an intervention group (n = 10) or control group (n = 10). PICU Soothing consisted of: 1) parental comforting (touch and reading), followed by 2) a quiet period with music via soft headbands, administered once daily throughout hospitalization. Acceptability and feasibility of the intervention and methods were assessed via participation rates, observation, measurement completion rates, semistructured interviews, and telephone calls. Psychological well-being was assessed using measures of distress, sleep, and child and parent anxiety in the PICU, on the wards and 3 months post discharge. Forty-four percent of parents agreed to participate. Seventy percent and 100% of intervention group parents responded positively to comforting and music, respectively. Most intervention group parents (70%) and all nurses felt children responded positively. All nurses found the intervention acceptable and feasible. Measurement completion rates ranged from 70% to 100%. Pilot data suggested lower intervention group child and parent anxiety after transfer to hospital wards. PICU Soothing is acceptable and feasible to conduct. Results support the implementation of a full-scale randomized controlled trial to evaluate intervention effectiveness.

Randomized controlled pilot study to compare Homeopathy and Conventional therapy in Acute Otitis Media.

Science.gov (United States)

Sinha, M N; Siddiqui, V A; Nayak, C; Singh, Vikram; Dixit, Rupali; Dewan, Deepti; Mishra, Alok

2012-01-01

To compare the effectiveness of Homeopathy and Conventional therapy in Acute Otitis Media (AOM). A randomized placebo-controlled parallel group pilot study of homeopathic vs conventional treatment for AOM was conducted in Jaipur, India. Patients were randomized by a computer generated random number list to receive either individualized homeopathic medicines in fifty millesimal (LM) potencies, or conventional treatment including analgesics, antipyretics and anti-inflammatory drugs. Patients who did not improve were prescribed antibiotics at the 3rd day. Outcomes were assessed by the Acute Otitis Media-Severity of Symptoms (AOM-SOS) Scale and Tympanic Membrane Examination over 21 days. 81 patients were included, 80 completed follow-up: 41 for conventional and 40 for homeopathic treatment. In the Conventional group, all 40 (100%) patients were cured, in the Homeopathy group, 38 (95%) patients were cured while 02 (5%) patients were lost to the last two follow-up. By the 3rd day of treatment, 4 patients were cured in Homeopathy group but in Conventional group only one patient was cured. In the Conventional group antibiotics were prescribed in 39 (97.5%), no antibiotics were required in the Homeopathy group. 85% of patients were prescribed six homeopathic medicines. Individualized homeopathy is an effective conventional treatment in AOM, there were no significant differences between groups in the main outcome. Symptomatic improvement was quicker in the Homeopathy group, and there was a large difference in antibiotic requirements, favouring homeopathy. Further work on a larger scale should be conducted. Copyright © 2011 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

Prospective, randomized evaluation of a personal digital assistant-based research tool in the emergency department

Directory of Open Access Journals (Sweden)

Dinizio Anthony

2008-01-01

Full Text Available Abstract Background Personal digital assistants (PDA offer putative advantages over paper for collecting research data. However, there are no data prospectively comparing PDA and paper in the emergency department. The aim of this study was to prospectively compare the performance of PDA and paper enrollment instruments with respect to time required and errors generated. Methods We randomized consecutive patients enrolled in an ongoing prospective study to having their data recorded either on a PDA or a paper data collection instrument. For each method, we recorded the total time required for enrollment, and the time required for manual transcription (paper onto a computer database. We compared data error rates by examining missing data, nonsensical data, and errors made during the transcription of paper forms. Statistical comparisons were performed by Kruskal-Wallis and Poisson regression analyses for time and errors, respectively. Results We enrolled 68 patients (37 PDA, 31 paper. Two of 31 paper forms were not available for analysis. Total data gathering times, inclusive of transcription, were significantly less for PDA (6:13 min per patient compared to paper (9:12 min per patient; p Conclusion Using a PDA-based data collection instrument for clinical research reduces the time required for data gathering and significantly improves data integrity.

Preoperative home-based physical therapy versus usual care to improve functional health of frail older adults scheduled for elective total hip arthroplasty: A pilot randomized controlled trial

NARCIS (Netherlands)

Oosting, E.; Jans, M.P.; Dronkers, J.J.; Naber, R.H.; Dronkers-Landman, C.M.; Appelman-De Vries, S.M.; Meeteren, N.L. van

2012-01-01

Preoperative home-based physical therapy versus usual care to improve functional health of frail older adults scheduled for elective total hip arthroplasty: a pilot randomized controlled trial. Objective: To investigate the feasibility and preliminary effectiveness of a home-based intensive exercise

A double-blind randomized controlled pilot trial examining the safety and efficacy of therapeutic touch in premature infants.

Science.gov (United States)

Whitley, Julie Anne; Rich, Bonnie L

2008-12-01

To explore the hypothesis that nontouch therapy such as therapeutic touch (TT) reduces stress to a clinically important degree and is safe to use in preterm infants. A pilot randomized, double-blind, controlled trial. Two groups of 10 infants were enrolled and randomly assigned to treatment or nontreatment groups. Gestational age was less than 29 weeks. Demographic descriptions of the 2 groups were statistically similar. The observer and staff were blinded to assignment; the TT practitioner was blinded to observed measurements. Each infant received either TT or no therapeutic touch (NTT) for 5 minutes on 3 consecutive days at the same time of day, behind a curtain. Heart period variability (HPV) was measured 5 minutes before, during, and after the treatment phase. Examination of the parameters of oxygen saturation and episodes of apnea demonstrated no increase in adverse events in TT group compared with NTT group. Repeated-measures multivariate analysis of variance on HPV revealed differences in the interaction of group assignment with low-frequency, high-frequency, and low-to-high- frequency ratio interaction (F2,143 = 8.076, P = .000) and for group, day, and low-frequency, high-frequency, and low-to-high-frequency ratio (F2,288 = 3.146, P = .015), and in the posttreatment time period (F1,16 = 6.259, P = .024), reflective of greater parasympathetic activity in TT group. In this pilot trial, HPV showed an increase for the TT group compared with the NTT group. The study reveals no adverse effects of TT in preterm infants.

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

Science.gov (United States)

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

2017-07-01

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

A Pilot Randomized Controlled Trial of Cognitive-Behavioral Therapy for Adolescents With Body Dysmorphic Disorder.

Science.gov (United States)

Mataix-Cols, David; Fernández de la Cruz, Lorena; Isomura, Kayoko; Anson, Martin; Turner, Cynthia; Monzani, Benedetta; Cadman, Jacinda; Bowyer, Laura; Heyman, Isobel; Veale, David; Krebs, Georgina

2015-11-01

Body dysmorphic disorder (BDD) typically starts in adolescence, but evidence-based treatments are yet to be developed and formally evaluated in this age group. We designed an age-appropriate cognitive-behavioral therapy (CBT) protocol for adolescents with BDD and evaluated its acceptability and efficacy in a pilot randomized controlled trial. Thirty adolescents aged 12 to 18 years (mean = 16.0, SD = 1.7) with a primary diagnosis of BDD, together with their families, were randomly assigned to 14 sessions of CBT delivered over 4 months or a control condition of equivalent duration, consisting of written psycho-education materials and weekly telephone monitoring. Blinded evaluators assessed participants at baseline, midtreatment, posttreatment, and at 2-month follow-up. The primary outcome measure was the Yale-Brown Obsessive-Compulsive Scale Modified for BDD, Adolescent Version (mean baseline score = 37.13, SD = 4.98, range = 24-43). The CBT group showed a significantly greater improvement than the control group, both at posttreatment (time × group interaction coefficient [95% CI] = -11.26 [-17.22 to -5.31]; p = .000) and at 2-month follow-up (time × group interaction coefficient [95% CI] = -9.62 [-15.74 to -3.51]; p = .002). Six participants (40%) in the CBT group and 1 participant (6.7%) in the control condition were classified as responders at both time points (χ(2) = 4.658, p = .031). Improvements were also seen on secondary measures, including insight, depression, and quality of life at posttreatment. Both patients and their families deemed the treatment as highly acceptable. Developmentally tailored CBT is a promising intervention for young people with BDD, although there is significant room for improvement. Further clinical trials incorporating lessons learned in this pilot study and comparing CBT and pharmacological therapies, as well as their combination, are warranted. Cognitive-Behaviour Therapy for Adolescents With Body Dysmorphic Disorder; http

Effect of Continuous Positive Airway Pressure on Stroke Rehabilitation: A Pilot Randomized Sham-Controlled Trial

Science.gov (United States)

Khot, Sandeep P.; Davis, Arielle P.; Crane, Deborah A.; Tanzi, Patricia M.; Li Lue, Denise; Claflin, Edward S.; Becker, Kyra J.; Longstreth, W.T.; Watson, Nathaniel F.; Billings, Martha E.

2016-01-01

Study Objectives: Obstructive sleep apnea (OSA) predicts poor functional outcome after stroke and increases the risk for recurrent stroke. Less is known about continuous positive airway pressure (CPAP) treatment on stroke recovery. Methods: In a pilot randomized, double-blind, sham-controlled trial, adult stroke rehabilitation patients were assigned to auto-titrating or sham CPAP without diagnostic testing for OSA. Change in Functional Independence Measure (FIM), a measure of disability, was assessed between rehabilitation admission and discharge. Results: Over 18 months, 40 patients were enrolled and 10 withdrew from the study: 7 from active and 3 from sham CPAP (p > 0.10). For the remaining 30 patients, median duration of CPAP use was 14 days. Average CPAP use was 3.7 h/night, with at least 4 h nightly use among 15 patients. Adherence was not influenced by treatment assignment or stroke severity. In intention-to-treat analyses (n = 40), the median change in FIM favored active CPAP over sham but did not reach statistical significance (34 versus 26, p = 0.25), except for the cognitive component (6 versus 2.5, p = 0.04). The on-treatment analyses (n = 30) yielded similar results (total FIM: 32 versus 26, p = 0.11; cognitive FIM: 6 versus 2, p = 0.06). Conclusions: A sham-controlled CPAP trial among stroke rehabilitation patients was feasible in terms of recruitment, treatment without diagnostic testing and adequate blinding—though was limited by study retention and CPAP adherence. Despite these limitations, a trend towards a benefit of CPAP on recovery was evident. Tolerance and adherence must be improved before the full benefits of CPAP on recovery can be assessed in larger trials. Citation: Khot SP, Davis AP, Crane DA, Tanzi PM, Li Lue D, Claflin ES, Becker KJ, Longstreth WT, Watson NF, Billings ME. Effect of continuous positive airway pressure on stroke rehabilitation: a pilot randomized sham-controlled trial. J Clin Sleep Med 2016;12(7):1019–1026. PMID

Managing mobility outcomes in vulnerable seniors ( MMOVeS): a randomized controlled pilot study.

Science.gov (United States)

Figueiredo, Sabrina; Morais, Jose A; Mayo, Nancy

2017-12-01

To estimate feasibility and potential for efficacy of an individualized, exercise-focused, self-management program (i.e. Managing Mobility Outcomes In Vulnerable Seniors ( MMOVeS)), in comparison to exercise information in improving mobility after six months among seniors recently discharged from hospital. Randomized pilot study. Two McGill University-teaching hospitals. Community dwelling seniors, aged 70 years and older, recently discharged from either participating hospitals. The physiotherapy-facilitated intervention consisted of (1) evaluation of mobility capacity, (2) setting short- and long-term goals, (3) delineation of an exercise treatment plan, (4) an educational booklet to enhance mobility self-management skills, and (5) six monthly telephone calls. Control group received a booklet with information on exercises targeting mobility limitations in seniors. Mobility, pain, and health status were assessed at baseline and at six months using multiple indicators drawn from Disabilities of the Arm, Shoulder, and Hand (DASH) Score, Lower Extremity Functional Scale (LEFS) and Short-Form (SF)-36. In all, 26 people were randomized to the intervention (mean age: 81 ± 8; 39% women), and 23 were randomized to the control (mean age: 79 ± 7; 33% women). The odds ratio for the mobility outcomes combined was 3.08 and the 95% confidence interval excluded 1 (1.65-5.77). The odds ratio for pain and health perception favored the MMOVeS group, but the 95% confidence interval included the null value. This feasibility study highlights the potential for efficacy of an individualized, exercise-focused, self-management program in comparison to exercise information in improving mobility outcome for seniors. Furthermore, a home-program combining self-management skills and exercise taught with minimal supervision prove to be feasible. Finally, data from this study can be used to estimate sample size for a confirmatory trial.

Subacute effects of cervicothoracic spinal thrust/non-thrust in addition to shoulder manual therapy plus exercise intervention in individuals with subacromial impingement syndrome: a prospective, randomized controlled clinical trial pilot study.

Science.gov (United States)

Wright, Alexis A; Donaldson, Megan; Wassinger, Craig A; Emerson-Kavchak, Alicia J

2017-09-01

To determine the subacute effects of cervicothoracic spinal thrust/non-thrust in addition to shoulder non-thrust plus exercise in patients with subacromial pathology. This was a randomized, single blinded controlled trial pilot study. This trial was registered at ClinicalTrials.gov (NCT01753271) and reported according to Consolidated Standards of Reporting Trials requirements. Patients were randomly assigned to either shoulder treatment plus cervicothoracic spinal thrust/non-thrust or shoulder treatment-only group. Primary outcomes were average pain intensity (Numeric Pain Rating Scale) and physical function (Shoulder Pain and Disability Index) at 2 weeks, 4 weeks, and patient discharge. 18 patients, mean age 43.1(15.8) years satisfied the eligibility criteria and were analyzed for follow-up data. Both groups showed statistically significant improvements in both pain and function at 2 weeks, 4 weeks, and discharge. The between-group differences for changes in pain or physical function were not significant at any time point. The addition of cervicothoracic spinal thrust/non-thrust to the shoulder treatment-only group did not significantly alter improvement in pain or function in patients with subacromial pathology. Both approaches appeared to provide an equally notable benefit. Both groups improved on all outcomes and met the criteria for clinical relevance for both pain and function. 2b.

Prophylactic amnioinfusion in preganancies complicated by chorioamnionitis: a prospective randomized trial.

Science.gov (United States)

Parilla, B V; McDermott, T M

1998-01-01

The objective of this article is to prospectively investigate the efficacy of amnioinfusion as a means to reduce febrile morbidity in pregnancies complicated by chorioamnionitis. All laboring patients with a temperature > or =100.1 degrees F were approached for study participation. Exclusion criteria included amnionitis diagnosed at greater than 8 cm dilation, multiple gestation, placental abruption, or a nonreassuring fetal heart rate tracing. Consenting patients were randomized to receive antibiotics (ampicillin or penicillin with gentamicin) and acetaminophen with or without amnioinfusion. All patients received intrauterine pressure catheter placement. For study patients, normal saline at room temperature was infused at 10 mL/min for 60 min, then 3 mL/min until delivery. Postpartum endometritis was defined as a temperature = 100.4 degrees F accompanied by uterine tenderness more than 12 hr after delivery. Statistical analysis was performed using the Student's t-test for continuous data and Chi-square for discrete variables. Thirty-six patients were enrolled, and complete data were available for 34 patients (17 in each group). There were no differences between groups with respect to maternal age, gravidity, race, or gestational age. There were also no differences between groups in duration of rupture of membranes, temperature at randomization, interval from randomization to delivery, cesarean section rate, or umbilical cord arterial pH. The mean temperature at the time of delivery was 99.8+/-0.9 degrees F for the amnioinfusion group versus 100.5+/-1.0 degrees F for the control group (p=0.046). Three of 17 amnioinfusion patients and 3 of 17 control patients had postpartum endometritis. There was 1 neonatal infection in the treatment group and no neonatal infections among the control patients. Prophylactic amnioinfusion was associated with a decline in temperature at the time of delivery. No untoward effects from the amnioinfusion were identified.

The Development of an Internet-Based Treatment for Problem Gamblers and Concerned Significant Others: A Pilot Randomized Controlled Trial.

Science.gov (United States)

Nilsson, Anders; Magnusson, Kristoffer; Carlbring, Per; Andersson, Gerhard; Gumpert, Clara Hellner

2018-06-01

Problem gambling creates significant harm for the gambler and for concerned significant others (CSOs). While several studies have investigated the effects of individual cognitive behavioral therapy (CBT) for problem gambling, less is known about the effects of involving CSOs in treatment. Behavioral couples therapy (BCT) has shown promising results when working with substance use disorders by involving both the user and a CSO. This pilot study investigated BCT for problem gambling, as well as the feasibility of performing a larger scale randomized controlled trial. 36 participants, 18 gamblers and 18 CSOs, were randomized to either BCT or individual CBT for the gambler. Both interventions were Internet-delivered self-help interventions with therapist support. Both groups of gamblers improved on all outcome measures, but there were no differences between the groups. The CSOs in the BCT group lowered their scores on anxiety and depression more than the CSOs of those randomized to the individual CBT group did. The implications of the results and the feasibility of the trial are discussed.

Feasibility of a Psychosocial Rehabilitation Intervention to Enhance the Involvement of Relatives in Cancer Rehabilitation: Pilot Study for a Randomized Controlled Trial

DEFF Research Database (Denmark)

L, Ledderer; KI, Cour; O, Mogensen

2013-01-01

. We developed an innovative rehabilitation program to be offered to the patient and a relative as a pair. Objective The aim of the present pilot study was to examine the feasibility of the intervention in a randomized controlled trial (RCT) and to evaluate the impact on quality of life. Methods...... significant difference was observed between the intervention and the control group. Pairs reported that the time of inclusion was inconvenient and that rehabilitation ought to meet their changing needs. Conclusions The pilot study showed that it may be difficult to conduct an RCT of a psychosocial...... rehabilitation intervention for pairs, and difficulties with inclusion and drop out have to be addressed. Interventions need to be carefully developed and tested before evaluating an effect in a large-scale study....

Laparoscopic Sleeve Gastrectomy versus Laparoscopic Banded Sleeve Gastrectomy: First Prospective Pilot Randomized Study

Directory of Open Access Journals (Sweden)

Valeria Tognoni

2016-01-01

Full Text Available Introduction. The placement of ring or band around the gastric tube might prevent the dilation after Laparoscopic Sleeve Gastrectomy (LSG. We describe the first randomized study comparing LSG and Laparoscopic Banded Sleeve Gastrectomy (LBSG. Material and Method. Fifty obese patients were enrolled in the study between January 2014 and January 2015. We analysed differences in operative time, complication rate, mortality, and BMI between the two groups over a period of 12 months. Results. Twenty-five patients received LSG (group A and 25 LBSG (group B. The mean preoperative BMI was 47.3±6.58 kg/m2 and 44.95±5.85 kg/m2, respectively, in the two groups. There was no statistical relevant difference in operative time. No intraoperative complications occurred. Mean BMI registered after 3, 6, and 12 months in groups A and B, respectively, were 37.86±5.72 kg/m2 and 37.58±6.21 kg/m2 (p=0.869, 33.64±6.08 kg/m2 and 32.03±5.24 kg/m2 (p=0.325, and 29.72±4.40 kg/m2 and 27.42±4.47 kg/m2 (p=0.186; no statistical relevant difference was registered between the two groups. Conclusion. LBSG is a safe and feasible procedure. The time required for the device positioning did not influence significantly the surgical time. The results of bodyweight loss did not document any statistically significant differences among the two groups, even though LBSG group showed a mean BMI slightly lower than that of the control group.

A Naturalistic, Randomized Pilot Trial of E-Cigarettes: Uptake, Exposure, and Behavioral Effects.

Science.gov (United States)

Carpenter, Matthew J; Heckman, Bryan W; Wahlquist, Amy E; Wagener, Theodore L; Goniewicz, Maciej L; Gray, Kevin M; Froeliger, Brett; Cummings, K Michael

2017-12-01

Background: Most studies of electronic nicotine delivery systems (ENDS) compare self-selected users versus nonusers. The few randomized studies to date generally support a positive impact on reducing smoking behavior, but these studies are focused on guided ENDS use. This study presents a randomized, naturalistic trial of ENDS with prospective outcomes of uptake and behavioral changes in smoking. Methods: Adult smokers with minimal ENDS history were randomized in a 2:1 ratio to receive product for 3 weeks ( n = 46), or not ( n = 22). Changes in nicotine delivery (16 vs. 24 mg), midway through the study allowed a compelling opportunity to examine two ENDS products compared with the control group. Primary outcomes, assessed via daily diaries during sampling period and in-person laboratory visits over 4 months, included uptake and usage of ENDS, cessation-related outcomes, and exposure to smoke constituents. Results: All ENDS participants tried product at least once, with 48% of 24 mg and 30% of 16 mg using their assigned product for the entire sampling period. Within the 24 mg ENDs group, 57% made an independent purchase of ENDS, versus 28% of 16 mg, and 14% of control participants ( P = 0.01). Smokers in both ENDS groups significantly reduced their smoking, whereas control participants did not ( P = 0.03). Cessation behaviors (quit attempts, biologically verified abstinence) numerically but not statistically favored ENDS participants. Conclusions: Results suggest that cigarette smokers are willing to use ENDS with trends toward reduced cigarette smoking and positive changes in cessation-related behaviors. Impact: Randomized, naturalistic trials such as presented herein are needed to understand the population impact of e-cigarettes. Cancer Epidemiol Biomarkers Prev; 26(12); 1795-803. ©2017 AACR . ©2017 American Association for Cancer Research.

The continuous reaction time test for minimal hepatic encephalopathy validated by a randomized controlled multi-modal intervention-A pilot study

DEFF Research Database (Denmark)

Lauridsen, M M; Mikkelsen, S; Svensson, T

2017-01-01

Background: Minimal hepatic encephalopathy (MHE) is clinically undetectable and the diagnosis requires psychometric tests. However, a lack of clarity exists as to whether the tests are in fact able to detect changes in cognition. Aim: To examine if the continuous reaction time test (CRT) can detect...... changes in cognition with anti-HE intervention in patients with cirrhosis and without clinically manifest hepatic encephalopathy (HE). Methods: Firstly, we conducted a reproducibility analysis and secondly measured change in CRT induced by anti-HE treatment in a randomized controlled pilot study: We...... stratified 44 patients with liver cirrhosis and without clinically manifest HE according to a normal (n = 22) or abnormal (n = 22) CRT. Each stratum was then block randomized to receive multimodal anti-HE intervention (lactulose+branched-chain amino acids+rifaximin) or triple placebos for 3 months...

A Pilot Randomized Controlled Trial to Promote Immunosuppressant Adherence in Adult Kidney Transplant Recipients.

Science.gov (United States)

Cukor, Daniel; Ver Halen, Nisha; Pencille, Melissa; Tedla, Fasika; Salifu, Moro

2017-01-01

Nonadherence to immunosuppressant medication is a prevalent practice among kidney transplant recipients and has been associated with increased risk for graft failure and economic burden. The aim of this pilot study was to test whether a culturally sensitive cognitive-behavioral adherence promotion program could significantly improve medication adherence to tacrolimus prescription as measured by telephone pill counts among kidney transplant recipients. Thirty-three adult transplant recipients were less than 98% adherent to tacrolimus prescription based on 3 telephone pill counts and were randomized either to the 2-session cognitive-behavioral adherence promotion program or to standard care. The curriculum was developed from an iterative process with transplant recipients into a 2-session group program that provided psychoeducation, addressed barriers to adherence, fostered motivation to improve adherence behavior, and discussed cultural messages on adherence behavior. The intervention group displayed significantly higher levels of adherence when compared to the control group (t = 2.2, p = 0.04) and. similarly, when the amount of change was compared between the groups, the intervention group showed more change than the control condition (F (22,1) = 12.005, p = 0.003). Tacrolimus trough concentration levels were used as a secondary measure of adherence and, while there were no significant between-group differences for mean trough concentration levels, the variability in the trough levels did significantly decrease over time indicating more consistent pill-taking behavior in the intervention group. There is preliminary support for the pilot program as a successful intervention in helping patients with their immunosuppressant medication. © 2016 S. Karger AG, Basel.

A comparison of Kneipp hydrotherapy with conventional physiotherapy in the treatment of osteoarthritis: a pilot trial.

Science.gov (United States)

Schencking, Martin; Wilm, Stefan; Redaelli, Marcus

2013-01-01

An increasingly aging population implies an increasing prevalence of osteoarthritis (OA) of hip or knee. It has been ascertained that unspecific hydrotherapy of OA according to Sebastian Kneipp not only improves the range of mobility but also reduces pain significantly and increases the quality of life of the patients affected. The main aim of this pilot study was to determine the effects of hydrotherapy in comparison to conventional physiotherapy, and to analyze the feasibility of the study design under clinical circumstances. The study design is a prospective randomized controlled three-arm clinical pilot trial, carried out at a specialist clinic for integrative medicine. Thirty patients diagnosed with symptomatic OA of hip or knee and radiologic findings were randomly assigned to one of two intervention groups and a control group: hydrotherapy (group 1), physiotherapy (group 2), and both physiotherapy and hydrotherapy (group 3, control group) of the affected joint. pain intensity of the affected joint in the course of inpatient treatment; secondary outcome: health-related quality of life, joint-specific pain and mobility in the course of the study. Concerning the main outcome, intervention group 1 showed most beneficial effects in the course of inpatient treatment, followed by groups 3 and 2, and also the indirect flexion ability of hip or knee together with the general patient mobility through the "timed up and go" test were mainly improved within group 1 followed by groups 3 and 2. The results of this pilot study demonstrate beneficial effects of hydrotherapy. The study design is feasible. For statistically significant evidence and a robust conclusion of efficacy of Kneipp's hydrotherapy, a larger sample size is necessary. NCT 00950326.

Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial.

Science.gov (United States)

Street, Alexander J; Magee, Wendy L; Bateman, Andrew; Parker, Michael; Odell-Miller, Helen; Fachner, Jorg

2018-01-01

To assess the feasibility of a randomized controlled trial to evaluate music therapy as a home-based intervention for arm hemiparesis in stroke. A pilot feasibility randomized controlled trial, with cross-over design. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes. Participants' homes across Cambridgeshire, UK. Eleven people with stroke and arm hemiparesis, 3-60 months post stroke, following discharge from community rehabilitation. Each participant engaged in therapeutic instrumental music performance in 12 individual clinical contacts, twice weekly for six weeks. Feasibility was estimated by recruitment from three community stroke teams over a 12-month period, attrition rates, completion of treatment and successful data collection. Structured interviews were conducted pre and post intervention to establish participant tolerance and preference. Action Research Arm Test and Nine-hole Peg Test data were collected at weeks 1, 6, 9, 15 and 18, pre and post intervention by a blinded assessor. A total of 11 of 14 invited participants were recruited (intervention n = 6, waitlist n = 5). In total, 10 completed treatment and data collection. It cannot be concluded whether a larger trial would be feasible due to unavailable data regarding a number of eligible patients screened. Adherence to treatment, retention and interview responses might suggest that the intervention was motivating for participants. ClinicalTrials.gov identifier NCT 02310438.

Continuous spinal anesthesia versus combined spinal epidural block for major orthopedic surgery: prospective randomized study

Directory of Open Access Journals (Sweden)

Luiz Eduardo Imbelloni

Full Text Available CONTEXT AND OBJECTIVES: In major orthopedic surgery of the lower limbs, continuous spinal anesthesia (CSA and combined spinal epidural anesthesia (CSE are safe and reliable anesthesia methods. In this prospective randomized clinical study, the blockading properties and side effects of CSA were compared with single interspace CSE, among patients scheduled for major hip or knee surgery. DESIGN AND SETTING: Prospective clinical study conducted at the Institute for Regional Anesthesia, Hospital de Base, São José do Rio Preto. METHODS: 240 patients scheduled for hip arthroplasty, knee arthroplasty or femoral fracture treatment were randomly assigned to receive either CSA or CSE. Blockades were performed in the lateral position at the L3-L4 interspace. Puncture success, technical difficulties, paresthesia, highest level of sensory and motor blockade, need for complementary doses of local anesthetic, degree of technical difficulties, cardiocirculatory changes and postdural puncture headache (PDPH were recorded. At the end of the surgery, the catheter was removed and cerebrospinal fluid leakage was evaluated. RESULTS: Seven patients were excluded (three CSA and four CSE. There was significantly lower incidence of paresthesia in the CSE group. The resultant sensory blockade level was significantly higher with CSE. Complete motor blockade occurred in 110 CSA patients and in 109 CSE patients. Arterial hypotension was observed significantly more often in the CSE group. PDPH was observed in two patients of each group. CONCLUSION: Our results suggest that both CSA and CSE provided good surgical conditions with low incidence of complications. The sensory blockade level and hemodynamic changes were lower with CSA.

Laparoscopic versus open cholecystectomy in cirrhotic patients: a prospective randomized study.

Science.gov (United States)

El-Awadi, Saleh; El-Nakeeb, Ayman; Youssef, Tamer; Fikry, Amir; Abd El-Hamed, Tito M; Ghazy, Hosam; Foda, Elyamany; Farid, Mohamed

2009-02-01

Improved laparoscopic experience and techniques have made laparoscopic cholecystectomy (LC) feasible options in cirrhotic patients. This study was designed to compare the risk and benefits of open cholecystectomy (OC) versus LC in compensated cirrhosis. A randomized prospective study, in the period from October 2002 till December 2006, where 110 cirrhotic patients with symptomatic gallstone were randomly divided into OC group (55 patients) and LC group (55 patients). There was no operative mortality. In LC group 4 (7.33%) patients were converted to OC. Mean surgical time was significantly longer in OC group than LC group (96.13+17.35 min versus 76.13+15.12) P<0.05, associated with significantly higher intraoperative bleeding in OC group (P<0.01), necessitating blood transfusions to 7 (12.72%) patients in OC group. The time to resume diet was 18.36+8.18 h in LC group which is significantly earlier than in OC group 47.84+14.6h P<0.005. Hospital stay was significantly longer in OC group than LC group (6+1.74 days versus 1.87+1.11 days) P<0.01 with low postoperative morbidity. LC in cirrhotics is still complicated and highly difficult which associates with significant morbidity compared with that of patients without cirrhosis. However, it offers lower morbidity, shorter operative time; early resume dieting with less need for blood transfusion and reducing hospital stay than OC.

Nurse case-manager vs multifaceted intervention to improve quality of osteoporosis care after wrist fracture: randomized controlled pilot study.

Science.gov (United States)

Majumdar, S R; Johnson, J A; Bellerose, D; McAlister, F A; Russell, A S; Hanley, D A; Garg, S; Lier, D A; Maksymowych, W P; Morrish, D W; Rowe, B H

2011-01-01

Few outpatients with fractures are treated for osteoporosis in the years following fracture. In a randomized pilot study, we found a nurse case-manager could double rates of osteoporosis testing and treatment compared with a proven efficacious quality improvement strategy directed at patients and physicians (57% vs 28% rates of appropriate care). Few patients with fractures are treated for osteoporosis. An intervention directed at wrist fracture patients (education) and physicians (guidelines, reminders) tripled osteoporosis treatment rates compared to controls (22% vs 7% within 6 months of fracture). More effective strategies are needed. We undertook a pilot study that compared a nurse case-manager to the multifaceted intervention using a randomized trial design. The case-manager counseled patients, arranged bone mineral density (BMD) tests, and prescribed treatments. We included controls from our first trial who remained untreated for osteoporosis 1-year post-fracture. Primary outcome was bisphosphonate treatment and secondary outcomes were BMD testing, appropriate care (BMD test-treatment if bone mass low), and costs. Forty six patients untreated 1-year after wrist fracture were randomized to case-manager (n = 21) or multifaceted intervention (n = 25). Median age was 60 years and 68% were female. Six months post-randomization, 9 (43%) case-managed patients were treated with bisphosphonates compared with 3 (12%) multifaceted intervention patients (relative risk [RR] 3.6, 95% confidence intervals [CI] 1.1-11.5, p = 0.019). Case-managed patients were more likely than multifaceted intervention patients to undergo BMD tests (81% vs 52%, RR 1.6, 95%CI 1.1-2.4, p = 0.042) and receive appropriate care (57% vs 28%, RR 2.0, 95%CI 1.0-4.2, p = 0.048). Case-management cost was $44 (CDN) per patient vs $12 for the multifaceted intervention. A nurse case-manager substantially increased rates of appropriate testing and treatment for osteoporosis in

Prone position as prevention of lung injury in comatose patients: a prospective, randomized, controlled study.

Science.gov (United States)

Beuret, Pascal; Carton, Marie-Jose; Nourdine, Karim; Kaaki, Mahmoud; Tramoni, Gerard; Ducreux, Jean-Claude

2002-05-01

Comatose patients frequently exhibit pulmonary function worsening, especially in cases of pulmonary infection. It appears to have a deleterious effect on neurologic outcome. We therefore conducted a randomized trial to determine whether daily prone positioning would prevent lung worsening in these patients. Prospective, randomized, controlled study. Sixteen-bed intensive care unit. Fifty-one patients who required invasive mechanical ventilation because of coma with Glascow coma scores of 9 or less. In the prone position (PP) group: prone positioning for 4 h once daily until the patients could get up to sit in an armchair; in the supine position (SP) group: supine positioning. The primary end point was the incidence of lung worsening defined by an increase in the Lung Injury Score of at least 1 point since the time of randomization. The secondary end point was the incidence of ventilator-associated pneumonia (VAP). A total of 25 patients were randomly assigned to the PP group and 26 patients to the SP group. The characteristics of the patients from the two groups were similar at randomization. The incidence of lung worsening was lower in the PP group (12%) than in the SP group (50%) ( p=0.003). The incidence of VAP was 20% in the PP group and 38.4% in the SP group ( p=0.14). There was no serious complication attributable to prone positioning, however, there was a significant increase of intracranial pressure in the PP. In a selected population of comatose ventilated patients, daily prone positioning reduced the incidence of lung worsening.

A pilot randomized trial to prevent sexual dysfunction in postmenopausal breast cancer survivors starting adjuvant aromatase inhibitor therapy.

Science.gov (United States)

Advani, Pragati; Brewster, Abenaa M; Baum, George P; Schover, Leslie R

2017-08-01

A randomized pilot trial evaluated the hypothesis that early intervention lessens sexual dysfunction in the first year on aromatase inhibitors. A secondary aim was comparing the efficacy of two vaginal moisturizers. Fifty-seven postmenopausal women with early stage breast cancer starting aromatase inhibitors were randomized to three treatment groups. All received a handout on managing sexual and other side effects. The Usual Care group received no additional therapy. The Active Treatment groups received a 6-month supply of a vaginal moisturizer (hyaluronic acid-based in Active Group-H and prebiotic in Active Group-P) and a vaginal lubricant and dilator, plus access to an educational website and phone coaching. Questionnaires completed at baseline, 6, and 12 months included the Female Sexual Function Index (FSFI), Menopausal Sexual Interest Questionnaire (MSIQ), Female Sexual Distress Scale-Revised (FSDS-R), and a menopausal symptom scale. Forty-nine women (86%) provided follow-up data. Mean age was 59 and 77% were non-Hispanic Caucasian. Sexual function was impaired at baseline, but remained stable over 12 months for all groups. The combined active treatment group had less dyspareunia (P = 0.07) and sexual distress (P = 0.02) at 6 months than the Usual Care group. At 6 months, the Active-H group improved significantly more than the Active-P group on FSFI total score (P = 0.04). Sexual counseling helped women maintain stable sexual function on aromatase inhibitors. Active intervention resulted in better outcomes at 6 months. This promising pilot trial suggests a need for more research on preventive counseling to maintain sexual function during aromatase inhibitor treatment.

A yoga intervention for type 2 diabetes risk reduction: a pilot randomized controlled trial

Science.gov (United States)

2014-01-01

Background Type 2 diabetes is a major health problem in many countries including India. Yoga may be an effective type 2 diabetes prevention strategy in India, particularly given its cultural familiarity. Methods This was a parallel, randomized controlled pilot study to collect feasibility and preliminary efficacy data on yoga for diabetes risk factors among people at high risk of diabetes. Primary outcomes included: changes in BMI, waist circumference, fasting blood glucose, postprandial blood glucose, insulin, insulin resistance, blood pressure, and cholesterol. We also looked at measures of psychological well-being including changes in depression, anxiety, positive and negative affect and perceived stress. Forty-one participants with elevated fasting blood glucose in Bangalore, India were randomized to either yoga (n = 21) or a walking control (n = 20). Participants were asked to either attend yoga classes or complete monitored walking 3–6 days per week for eight weeks. Randomization and allocation was performed using computer-generated random numbers and group assignments delivered in sealed, opaque envelopes generated by off-site study staff. Data were analyzed based on intention to treat. Results This study was feasible in terms of recruitment, retention and adherence. In addition, yoga participants had significantly greater reductions in weight, waist circumference and BMI versus control (weight −0.8 ± 2.1 vs. 1.4 ± 3.6, p = 0.02; waist circumference −4.2 ± 4.8 vs. 0.7 ± 4.2, p yoga intervention and walking control over the course of the study. Conclusion Among Indians with elevated fasting blood glucose, we found that participation in an 8-week yoga intervention was feasible and resulted in greater weight loss and reduction in waist circumference when compared to a walking control. Yoga offers a promising lifestyle intervention for decreasing weight-related type 2 diabetes risk factors and potentially increasing

Evaluation of a "Just-in-Time" Nurse Consultation on Bone Health: A Pilot Randomized Controlled Trial.

Science.gov (United States)

Roblin, Douglas W; Zelman, David; Plummer, Sally; Robinson, Brandi E; Lou, Yiyue; Edmonds, Stephanie W; Wolinsky, Fredric D; Saag, Kenneth G; Cram, Peter

2017-01-01

Evidence is inconclusive whether a nurse consultation can improve osteoporosis-related patient outcomes. To evaluate whether a nurse consultation immediately after dual-energy x-ray absorptiometry (DXA) produced better osteoporosis-related outcomes than a simple intervention to activate adults in good bone health practices or usual care. Pilot randomized controlled trial, conducted within the larger Patient Activation After DXA Result Notification (PAADRN) trial (NCT01507662). After DXA, consenting adults age 50 years or older were randomly assigned to 3 groups: nurse consultation, PAADRN intervention (mailed letter with individualized fracture risk and an educational brochure), or usual care (control). Nurse consultation included reviewing DXA results, counseling on bone health, and ordering needed follow-up tests or physician referrals. Change from baseline to 52 weeks in participant-reported osteoporosis-related pharmacotherapy, lifestyle, activation and self-efficacy, and osteoporosis care satisfaction. Nurse consultation participants (n = 104) reported 52-week improvements in strengthening and weight-bearing exercise (p = 0.09), calcium intake (p Just-in-time" nurse consultation yielded a few improvements over 52 weeks in osteoporosis-related outcomes; however, most changes were not different from those obtained through the lower-cost PAADRN intervention or usual care.

Monetary Incentives Improve Recall of Research Consent Information: A Randomized Pilot Study

Science.gov (United States)

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

2011-01-01

Research participants often fail to recall substantial amounts of informed consent information after delays of only a few days. Numerous interventions have proven effective at improving consent recall; however, virtually all have focused on compensating for potential cognitive deficits and have ignored motivational factors. In this pilot study, we randomly assigned 31 drug court clients participating in a clinical research trial to a standard consent procedure or to the same procedure plus incentives for correctly recalling consent information. The incentive group was told they would receive $5 for each of the 15 consent items they could answer correctly 1-week later. At the follow-up, the incentive group recalled a significantly greater percentage of consent information overall than the standard group (65% vs. 42%; p < .01). Similar findings were observed for specific categories of consent information, including study purpose and design, risks and benefits, and human subject protections. Effect sizes were all large (d = 0.89 to 1.25). Findings suggest that motivation plays a key role in recall of consent information and should be considered in the development of future interventions. PMID:19331486

Infant skin-cleansing product versus water: A pilot randomized, assessor-blinded controlled trial

Directory of Open Access Journals (Sweden)

Cork Michael J

2011-05-01

Full Text Available Abstract Background The vulnerability of newborn babies' skin creates the potential for a number of skin problems. Despite this, there remains a dearth of good quality evidence to inform practice. Published studies comparing water with a skin-cleansing product have not provided adequate data to inform an adequately powered trial. Nor have they distinguished between babies with and without a predisposition to atopic eczema. We conducted a pilot study as a prequel to designing an optimum trial to investigate whether bathing with a specific cleansing product is superior to bathing with water alone. The aims were to produce baseline data which would inform decisions for the main trial design (i.e. population, primary outcome, sample size calculation and to optimize the robustness of trial processes within the study setting. Methods 100 healthy, full term neonates aged Results Forty nine babies were randomized to cleansing product, 51 to water. The 95% confidence intervals (CI for the average TEWL measurement at each time point were: whole sample at baseline: 10.8 g/m2/h to 11.7 g/m2/h; CP group 4 weeks: 10.9 g/m2/h to 13.3 g/m2/h; 8 weeks: 11.4 g/m2/h to 12.9 g/m2/h; W group 4 weeks:10.9 g/m2/h to 12.2 g/m2/h; 8 weeks: 11.4 g/m2/h to 12.9 g/m2/h. Conclusion This pilot study provided valuable baseline data and important information on trial processes. The decision to proceed with a superiority trial, for example, was inconsistent with our data; therefore a non-inferiority trial is recommended. Trial registration ISRCTN72285670

The Effects of Experimentally Manipulated Social Status on Acute Eating Behavior: A Randomized, Crossover Pilot Study

Science.gov (United States)

Cardel, MI; Johnson, SL; Beck, J; Dhurandhar, E; Keita, AD; Tomczik, AC; Pavela, G; Huo, T; Janicke, DM; Muller, K; Piff, PK; Peters, JC; Hill, JO; Allison, DB

2016-01-01

Both subjective and objectively measured social status has been associated with multiple health outcomes, including weight status, but the mechanism for this relationship remains unclear. Experimental studies may help identify the causal mechanisms underlying low social standing as a pathway for obesity. Our objective was to investigate the effects of experimentally manipulated social status on ad libitum acute dietary intakes and stress-related outcomes as potential mechanisms relating social status and weight. This was a pilot feasibility, randomized, crossover study in Hispanic young adults (n=9; age 19–25; 67% female; BMI ≥18.5 and ≤30 kg/m2). At visit 1, participants consumed a standardized breakfast and were randomized to a high social status position (HIGH) or low social status position (LOW) in a rigged game of Monopoly™. The rules for the game differed substantially in terms of degree of ‘privilege’ depending on randomization to HIGH or LOW. Following Monopoly™, participants were given an ad libitum buffet meal and energy intakes (kcal) were estimated by pre- and post-weighing foods consumed. Stress-related markers were measured at baseline, after the game of Monopoly™, and after lunch. Visit 2 used the same standardized protocol; however, participants were exposed to the opposite social status condition. When compared to HIGH, participants in LOW consumed 130 more calories (p=0.07) and a significantly higher proportion of their daily calorie needs in the ad libitum buffet meal (39% in LOW versus 31% in HIGH; p=0.04). In LOW, participants reported decreased feelings of pride and powerfulness following Monopoly™ (p=0.05) and after their lunch meal (p=0.08). Relative to HIGH, participants in LOW demonstrated higher heart rates following Monopoly™ (p=0.06), but this relationship was not significant once lunch was consumed (p=0.31). Our pilot data suggest a possible causal relationship between experimentally manipulated low social status

The effects of experimentally manipulated social status on acute eating behavior: A randomized, crossover pilot study.

Science.gov (United States)

Cardel, M I; Johnson, S L; Beck, J; Dhurandhar, E; Keita, A D; Tomczik, A C; Pavela, G; Huo, T; Janicke, D M; Muller, K; Piff, P K; Peters, J C; Hill, J O; Allison, D B

2016-08-01

Both subjective and objectively measured social status has been associated with multiple health outcomes, including weight status, but the mechanism for this relationship remains unclear. Experimental studies may help identify the causal mechanisms underlying low social standing as a pathway for obesity. Our objective was to investigate the effects of experimentally manipulated social status on ad libitum acute dietary intakes and stress-related outcomes as potential mechanisms relating social status and weight. This was a pilot feasibility, randomized, crossover study in Hispanic young adults (n=9; age 19-25; 67% female; BMI ≥18.5 and ≤30kg/m(2)). At visit 1, participants consumed a standardized breakfast and were randomized to a high social status position (HIGH) or low social status position (LOW) in a rigged game of Monopoly™. The rules for the game differed substantially in terms of degree of 'privilege' depending on randomization to HIGH or LOW. Following Monopoly™, participants were given an ad libitum buffet meal and energy intakes (kcal) were estimated by pre- and post-weighing foods consumed. Stress-related markers were measured at baseline, after the game of Monopoly™, and after lunch. Visit 2 used the same standardized protocol; however, participants were exposed to the opposite social status condition. When compared to HIGH, participants in LOW consumed 130 more calories (p=0.07) and a significantly higher proportion of their daily calorie needs in the ad libitum buffet meal (39% in LOW versus 31% in HIGH; p=0.04). In LOW, participants reported decreased feelings of pride and powerfulness following Monopoly™ (p=0.05) and after their lunch meal (p=0.08). Relative to HIGH, participants in LOW demonstrated higher heart rates following Monopoly™ (p=0.06), but this relationship was not significant once lunch was consumed (p=0.31). Our pilot data suggest a possible causal relationship between experimentally manipulated low social status and

Effects of Combining a Brief Cognitive Intervention with Transcranial Direct Current Stimulation on Pain Tolerance: A Randomized Controlled Pilot Study.

Science.gov (United States)

Powers, Abigail; Madan, Alok; Hilbert, Megan; Reeves, Scott T; George, Mark; Nash, Michael R; Borckardt, Jeffrey J

2018-04-01

Cognitive behavioral therapy has been shown to be effective for treating chronic pain, and a growing literature shows the potential analgesic effects of minimally invasive brain stimulation. However, few studies have systematically investigated the potential benefits associated with combining approaches. The goal of this pilot laboratory study was to investigate the combination of a brief cognitive restructuring intervention and transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex in affecting pain tolerance. Randomized, double-blind, placebo-controlled laboratory pilot. Medical University of South Carolina. A total of 79 healthy adult volunteers. Subjects were randomized into one of six groups: 1) anodal tDCS plus a brief cognitive intervention (BCI); 2) anodal tDCS plus pain education; 3) cathodal tDCS plus BCI; 4) cathodal tDCS plus pain education; 5) sham tDCS plus BCI; and 6) sham tDCS plus pain education. Participants underwent thermal pain tolerance testing pre- and postintervention using the Method of Limits. A significant main effect for time (pre-post intervention) was found, as well as for baseline thermal pain tolerance (covariate) in the model. A significant time × group interaction effect was found on thermal pain tolerance. Each of the five groups that received at least one active intervention outperformed the group receiving sham tDCS and pain education only (i.e., control group), with the exception of the anodal tDCS + education-only group. Cathodal tDCS combined with the BCI produced the largest analgesic effect. Combining cathodal tDCS with BCI yielded the largest analgesic effect of all the conditions tested. Future research might find stronger interactive effects of combined tDCS and a cognitive intervention with larger doses of each intervention. Because this controlled laboratory pilot employed an acute pain analogue and the cognitive intervention did not authentically represent cognitive behavioral

Incidence and severity of gingival invaginations associated with early versus late initiation of orthodontic space closure after tooth extraction : A multicenter pilot and randomized controlled trial.

Science.gov (United States)

Reichert, Christoph; Kutschera, Eric; Plötz, Christina; Scharf, Sven; Gölz, Lina; Fimmers, Rolf; Fuhrmann, Christine; Wahl, Gerhard; Braumann, Bert; Jäger, Andreas

2017-09-01

Gingival invaginations are a common side effect of orthodontic extraction-space closure. The timing of initiating the closure of an extraction space varies greatly in clinical practice. In this multicenter pilot and randomized controlled trial, we prospectively investigated whether initiating space closure in the early stage of wound healing would benefit the incidence and severity of invaginations developing in the extraction sites. A total of 368 patients were screened for indications to extract at least one mandibular premolar. Those recruited were randomly assigned to one of two treatment arms: initiation of space closure either 2-4 weeks (arm A) or ≥12 weeks (arm B) after tooth extraction. Clinical data regarding treatment process and periodontal tissue response were recorded during and after space closure and analyzed by a specialized biometrics unit. The study was performed under continuous surveillance by an independent study control center. A total of 74 extraction sites were analyzed. Regarding the incidence of gingival invaginations, there were no significant intergroup differences [p = 0.13; group A comprising 37/44 (84.1%) and group B 29/30 (96.7%) invaginated sites]. The same was true based on either maxillary (p = 0.52) or mandibular (p = 0.21) sites only, and the severity of the invaginations did not differ between the treatment arms. As to the incidence and severity of gingival invaginations, we did not notice any statistically significant differences between the two timeframes. Our data do, however, provide a basis to identify additional confounders and to improve the accuracy of case-load estimations for future trials.

A Pilot Randomized Trial of Text-Messaging for Symptom Awareness and Diabetes Knowledge in Adolescents With Type 1 Diabetes

Science.gov (United States)

Han, Yi; Faulkner, Melissa Spezia; Fritz, Heather; Fadoju, Doris; Muir, Andrew; Abowd, Gregory D.; Head, Lauren; Arriaga, Rosa I.

2015-01-01

Adolescents with type 1 diabetes typically receive clinical care every 3 months. Between visits, diabetes-related issues may not be frequently reflected, learned, and documented by the patients, limiting their self-awareness and knowledge about their condition. We designed a text-messaging system to help resolve this problem. In a pilot, randomized controlled trial with 30 adolescents, we examined the effect of text messages about symptom awareness and diabetes knowledge on glucose control and quality of life. The intervention group that received more text messages between visits had significant improvements in quality of life. PMID:25720675

Development and Pilot Testing of Daily Interactive Voice Response (IVR) Calls to Support Antiretroviral Adherence in India: A Mixed-Methods Pilot Study.

Science.gov (United States)

Swendeman, Dallas; Jana, Smarajit; Ray, Protim; Mindry, Deborah; Das, Madhushree; Bhakta, Bhumi

2015-06-01

This two-phase pilot study aimed to design, pilot, and refine an automated interactive voice response (IVR) intervention to support antiretroviral adherence for people living with HIV (PLH), in Kolkata, India. Mixed-methods formative research included a community advisory board for IVR message development, 1-month pre-post pilot, post-pilot focus groups, and further message development. Two IVR calls are made daily, timed to patients' dosing schedules, with brief messages (pilot results (n = 46, 80 % women, 60 % sex workers) found significant increases in self-reported ART adherence, both within past three days (p = 0.05) and time since missed last dose (p = 0.015). Depression was common. Messaging content and assessment domains were expanded for testing in a randomized trial currently underway.

An evidence-based walking program among older people with knee osteoarthritis: the PEP (participant exercise preference) pilot randomized controlled trial.

Science.gov (United States)

Loew, Laurianne; Brosseau, Lucie; Kenny, Glen P; Durand-Bush, Natalie; Poitras, Stéphane; De Angelis, Gino; Wells, George A

2017-07-01

Knee osteoarthritis is a common joint problem leading to an increase of pain and a loss of function in older individuals. The main objective of this study was to evaluate if a participant who was randomly assigned to his preferred group improved his adherence to an effective walking program compared to a participant who did not receive his preferred group. This was a 9-month pilot randomized clinical trial, based on a patient treatment preferences design. The 69 eligible participants had a diagnosis of knee osteoarthritis. Participants were randomized to one of two groups: a supervised community-based or unsupervised walking program, based on the Ottawa Panel guidelines. At 6 months, participants who expressed a preference, either for the supervised or unsupervised program, and who were assigned to their preferred choice of program showed significantly higher adherence to walking sessions (supervised 60.7 ± 12.3%, P walking program, while ensuring the maintenance of clinical benefits of walking, among older adults susceptible to avoid or not properly engage in physical activity.

Impact on Seniors of the Patient-Centered Medical Home: Evidence from a Pilot Study

Science.gov (United States)

Fishman, Paul A.; Johnson, Eric A.; Coleman, Kathryn; Larson, Eric B.; Hsu, Clarissa; Ross, Tyler R.; Liss, David; Tufano, James; Reid, Robert J.

2012-01-01

Purpose: To assess the impact on health care cost and quality among seniors of a patient-centered medical home (PCMH) pilot at Group Health Cooperative, an integrated health care system in Washington State. Design and Methods: A prospective before-and-after evaluation of the experience of seniors receiving primary care services at 1 pilot clinic…

Development and piloting of a food-based intervention to increase vitamin E intake in pregnant women in a randomized controlled trial.

Science.gov (United States)

Clark, Julia; Holgan, Nikki; Craig, Leone; Morgan, Heather; Danielian, Peter; Devereux, Graham

2016-11-01

Low maternal vitamin E intake during pregnancy is associated with childhood asthma and a trial is required to test whether increasing maternal vitamin E intake reduces childhood asthma. This study investigated whether such a trial is possible using food to increase vitamin E intake. Three soup varieties with enhanced vitamin E content (16-19 mg/can) from food ingredients were developed. Near identical retail versions (vitamin E 1-4 mg/can) acted as placebo. In a pilot double-blind randomized controlled trial, pregnant women were randomized 1:1 to enhanced or placebo soups (three tins/week) from 12 weeks gestation to delivery. Vitamin E intake was quantified at 12, 20, and 34 weeks gestation. Qualitative interviews were conducted. 59 women were randomized (29 enhanced, 30 placebo), 28 completed the trial, (15 enhanced, 13 placebo). In women completing the trial, vitamin E intake of the placebo group remained unchanged; 7.09 mg/d (95% CI 5.41-8.77) at 12 weeks, 6.41 mg/d (5.07-7.75) at 20 weeks, and 6.67 mg/d (5.38-7.96) at 34 weeks gestation; vitamin E intake of the enhanced group increased from 6.50 mg/d (5.21-7.79) at 12 weeks to 14.9 mg/d (13.3-16.4) at 20 weeks and 15.2 mg/d (12.9-17.5) at 34 weeks, P  clear guidance on improving adherence. Although 31 women withdrew at median 19 weeks gestation (interquartile range 16-25), the intervention was consumed by women for 80% of weeks between 12 and 34 weeks gestation and for 63% of weeks between 12 weeks gestation and delivery. In a pilot double-blind randomized controlled trial (RCT) it is possible to increase maternal vitamin E intake using food ingredients, a further food product is required to improve adherence.

The benefits of hypopharyngeal packing in nasal surgery: a pilot study.

LENUS (Irish Health Repository)

Fennessy, B G

2012-02-01

BACKGROUND: Hypopharyngeal packs are used in nasal surgery to reduce the risk of aspiration and postoperative nausea and vomiting. Side effects associated with their use range from throat pain to retained packs postoperatively. AIM: To evaluate, as a pilot study, postoperative nausea\\/vomiting and throat pain scores for patients undergoing nasal surgery in whom a wet or dry hypopharyngeal pack was placed compared with patients who received no packing. METHODS: A randomized, double-blind prospective trial in a general ENT unit. RESULTS: The study failed to show a statistically significant difference between the three groups in terms of their postoperative nausea\\/vomiting and throat pain scores at 2 and 6 h postoperatively. This is the first study in which dry packs have been compared with wet and absent packs. CONCLUSION: Based on our findings, the authors recommend against placing hypopharyngeal packs for the purpose of preventing postoperative nausea and vomiting.

Grappling with the Future: The Messiness of Pilot Implementation in Information Systems Design

DEFF Research Database (Denmark)

Hertzum, Morten; Manikas, Maria Ie; Torkilsheyggi, Arnvør Martinsdóttir á

2018-01-01

. In the first pilot implementation the involved porters saw their improved overview of pending patient transports as an opportunity for more self-organization but this opportunity hinged on the unclear prospects of extending the system with functionality for the porters to reply to transport requests....... In the second pilot implementation the involved paramedics had to print the data they entered into the system because it had not yet been integrated with the electronic patient record. This extra work prolonged every dispatch and influenced the paramedics’ experience of the entire system. We discuss how pilot......Pilot implementation is a method for avoiding unintended consequences of healthcare information systems. This study investigates how learning from pilot implementations is situated, messy, and therefore difficult. We analyze two pilot implementations by means of observation and interviews...

Association between Adult Height and Risk of Colorectal, Lung, and Prostate Cancer : Results from Meta-analyses of Prospective Studies and Mendelian Randomization Analyses

NARCIS (Netherlands)

Khankari, Nikhil K.; Shu, Xiao Ou; Wen, Wanqing; Kraft, Peter; Lindström, Sara; Peters, Ulrike; Schildkraut, Joellen; Schumacher, Fredrick; Bofetta, Paolo; Risch, Angela; Bickeböller, Heike; Amos, Christopher I.; Easton, Douglas; Eeles, Rosalind A.; Gruber, Stephen B.; Haiman, Christopher A.; Hunter, David J.; Chanock, Stephen J.; Pierce, Brandon L.; Zheng, Wei; Blalock, Kendra; Campbell, Peter T.; Casey, Graham; Conti, David V.; Edlund, Christopher K.; Figueiredo, Jane; James Gauderman, W.; Gong, Jian; Green, Roger C.; Harju, John F.; Harrison, Tabitha A.; Jacobs, Eric J.; Jenkins, Mark A.; Jiao, Shuo; Li, Li; Lin, Yi; Manion, Frank J.; Moreno, Victor; Mukherjee, Bhramar; Raskin, Leon; Schumacher, Fredrick R.; Seminara, Daniela; Severi, Gianluca; Stenzel, Stephanie L.; Thomas, Duncan C.; Hopper, John L.; Southey, Melissa C.; Makalic, Enes; Schmidt, Daniel F.; Fletcher, Olivia; Peto, Julian; Gibson, Lorna; dos Santos Silva, Isabel; Ahsan, Habib; Whittemore, Alice; Waisfisz, Quinten; Meijers-Heijboer, Hanne; Adank, Muriel; van der Luijt, Rob B.; Uitterlinden, Andre G.; Hofman, Albert; Meindl, Alfons; Schmutzler, Rita K.; Müller-Myhsok, Bertram; Lichtner, Peter; Nevanlinna, Heli; Muranen, Taru A.; Aittomäki, Kristiina; Blomqvist, Carl; Chang-Claude, Jenny; Hein, Rebecca; Dahmen, Norbert; Beckman, Lars; Crisponi, Laura; Hall, Per; Czene, Kamila; Irwanto, Astrid; Liu, Jianjun; Easton, Douglas F.; Turnbull, Clare; Rahman, Nazneen; Eeles, Rosalind; Kote-Jarai, Zsofia; Muir, Kenneth; Giles, Graham; Neal, David; Donovan, Jenny L.; Hamdy, Freddie C.; Wiklund, Fredrik; Gronberg, Henrik; Haiman, Christopher; Schumacher, Fred; Travis, Ruth; Riboli, Elio; Hunter, David; Gapstur, Susan; Berndt, Sonja; Chanock, Stephen; Han, Younghun; Su, Li; Wei, Yongyue; Hung, Rayjean J.; Brhane, Yonathan; McLaughlin, John; Brennan, Paul; McKay, James D.; Rosenberger, Albert; Houlston, Richard S.; Caporaso, Neil; Teresa Landi, Maria; Heinrich, Joachim; Wu, Xifeng; Ye, Yuanqing; Christiani, David C.

2016-01-01

Background: Observational studies examining associations between adult height and risk of colorectal, prostate, and lung cancers have generated mixed results. We conducted meta-analyses using data from prospective cohort studies and further carried out Mendelian randomization analyses, using

Recruitment methods and costs for a randomized, placebo-controlled trial of chiropractic care for lumbar spinal stenosis: a single-site pilot study.

Science.gov (United States)

Cambron, Jerrilyn A; Dexheimer, Jennifer M; Chang, Mabel; Cramer, Gregory D

2010-01-01

The purpose of this article is to describe the methods for recruitment in a clinical trial on chiropractic care for lumbar spinal stenosis. This randomized, placebo-controlled pilot study investigated the efficacy of different amounts of total treatment dosage over 6 weeks in 60 volunteer subjects with lumbar spinal stenosis. Subjects were recruited for this study through several media venues, focusing on successful and cost-effective strategies. Included in our efforts were radio advertising, newspaper advertising, direct mail, and various other low-cost initiatives. Of the 1211 telephone screens, 60 responders (5.0%) were randomized into the study. The most successful recruitment method was radio advertising, generating more than 64% of the calls (776 subjects). Newspaper and magazine advertising generated approximately 9% of all calls (108 subjects), and direct mail generated less than 7% (79 subjects). The total direct cost for recruitment was $40 740 or $679 per randomized patient. The costs per randomization were highest for direct mail ($995 per randomization) and lowest for newspaper/magazine advertising ($558 per randomization). Success of recruitment methods may vary based on target population and location. Planning of recruitment efforts is essential to the success of any clinical trial. Copyright 2010 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

Meal replacements followed by topiramate for the treatment of adolescent severe obesity: A pilot randomized controlled trial.

Science.gov (United States)

Fox, Claudia K; Kaizer, Alexander M; Rudser, Kyle D; Nathan, Brandon M; Gross, Amy C; Sunni, Muna; Jennifer Abuzzahab, M; Schwartz, Betsy L; Kumar, Seema; Petryk, Anna; Billington, Charles J; Ryder, Justin R; Kelly, Aaron S

2016-12-01

To assess the safety and efficacy of short-term meal replacement therapy followed by topiramate for body mass index (BMI) reduction in adolescents with severe obesity. Adolescents (ages 12-18 years) with severe obesity (BMI ≥1.2 times the 95th percentile or BMI ≥35 kg/m 2 ) were recruited for this double-blind, randomized, placebo-controlled trial. Participants completed 4 weeks of meal replacement therapy followed by randomization (1:1) to either 24 weeks of topiramate 75 mg/day or placebo. Mean changes were compared between groups. Thirty adolescents (mean age 15.2 ± 1.7 years, mean BMI 40.3 ± 4.6 kg/m 2 ) completed the meal replacement phase and were randomized; 21 completed the study. The difference in mean percent change in BMI between the topiramate and placebo groups was not significant (-1.9%; 95% CI: -5.2% to +1.5%; P = 0.291). Significant improvements in visceral fat and very-low-density lipoprotein cholesterol were observed in the topiramate compared with the placebo group. There were no concerning changes in neurocognitive function or bone health. In this pilot study, 4 weeks of meal replacement therapy followed by 24 weeks of low-dose topiramate compared with meal replacement therapy alone did not result in significant BMI reduction for adolescents with severe obesity. © 2016 The Obesity Society.

Recruitment to online therapies for depression: pilot cluster randomized controlled trial.

Science.gov (United States)

Jones, Ray B; Goldsmith, Lesley; Hewson, Paul; Williams, Christopher J

2013-03-05

Raising awareness of online cognitive behavioral therapy (CBT) could benefit many people with depression, but we do not know how purchasing online advertising compares to placing free links from relevant local websites in increasing uptake. To pilot a cluster randomized controlled trial (RCT) comparing purchase of Google AdWords with placing free website links in raising awareness of online CBT resources for depression in order to better understand research design issues. We compared two online interventions with a control without intervention. The pilot RCT had 4 arms, each with 4 British postcode areas: (A) geographically targeted AdWords, (B) adverts placed on local websites by contacting website owners and requesting links be added, (C) both interventions, (D) control. Participants were directed to our research project website linking to two freely available online CBT resource sites (Moodgym and Living Life To The Full (LLTTF)) and two other depression support sites. We used data from (1) AdWords, (2) Google Analytics for our project website and for LLTTF, and (3) research project website. We compared two outcomes: (1) numbers with depression accessing the research project website, and then chose an onward link to one of the two CBT websites, and (2) numbers registering with LLTTF. We documented costs, and explored intervention and assessment methods to make general recommendations to inform researchers aiming to use similar methodologies in future studies. Trying to place local website links appeared much less cost effective than AdWords and although may prove useful for service delivery, was not worth pursuing in the context of the current study design. Our AdWords intervention was effective in recruiting people to the project website but our location targeting "leaked" and was not as geographically specific as claimed. The impact on online CBT was also diluted by offering participants other choices of destinations. Measuring the impact on LLTTF use was

Centrifuge Study of Pilot Tolerance to Acceleration and the Effects of Acceleration on Pilot Performance

Science.gov (United States)

Creer, Brent Y.; Smedal, Harald A.; Wingrove, Rodney C.

1960-01-01

A research program the general objective of which was to measure the effects of various sustained accelerations on the control performance of pilots, was carried out on the Aviation Medical Acceleration Laboratory centrifuge, U.S. Naval Air Development Center, Johnsville, PA. The experimental setup consisted of a flight simulator with the centrifuge in the control loop. The pilot performed his control tasks while being subjected to acceleration fields such as might be encountered by a forward-facing pilot flying an atmosphere entry vehicle. The study was divided into three phases. In one phase of the program, the pilots were subjected to a variety of sustained linear acceleration forces while controlling vehicles with several different sets of longitudinal dynamics. Here, a randomly moving target was displayed to the pilot on a cathode-ray tube. For each combination of acceleration field and vehicle dynamics, pilot tracking accuracy was measured and pilot opinion of the stability and control characteristics was recorded. Thus, information was obtained on the combined effects of complexity of control task and magnitude and direction of acceleration forces on pilot performance. These tests showed that the pilot's tracking performance deteriorated markedly at accelerations greater than about 4g when controlling a lightly damped vehicle. The tentative conclusion was also reached that regardless of the airframe dynamics involved, the pilot feels that in order to have the same level of control over the vehicle, an increase in the vehicle dynamic stability was required with increases in the magnitudes of the acceleration impressed upon the pilot. In another phase, boundaries of human tolerance of acceleration were established for acceleration fields such as might be encountered by a pilot flying an orbital vehicle. A special pilot restraint system was developed to increase human tolerance to longitudinal decelerations. The results of the tests showed that human tolerance

Randomized controlled pilot trial of mindfulness-based stress reduction for breast and colorectal cancer survivors: effects on cancer-related cognitive impairment.

Science.gov (United States)

Johns, Shelley A; Von Ah, Diane; Brown, Linda F; Beck-Coon, Kathleen; Talib, Tasneem L; Alyea, Jennifer M; Monahan, Patrick O; Tong, Yan; Wilhelm, Laura; Giesler, R Brian

2016-06-01

Cancer-related cognitive impairment (CRCI) is a common, fatigue-related symptom that disrupts cancer survivors' quality of life. Few interventions for CRCI exist. As part of a randomized pilot study targeting cancer-related fatigue, the effects of mindfulness-based stress reduction (MBSR) on survivors' cognitive outcomes were investigated. Breast and colorectal cancer survivors (n = 71) with moderate-to-severe fatigue were randomized to MBSR (n = 35) or a fatigue education and support (ES; n = 36) condition. The Attentional Function Index (AFI) and the Stroop test were used to assess survivors' cognitive function at baseline (T1), after the 8-week intervention period (T2), and 6 months later (T3) using intent-to-treat analysis. Mediation analyses were performed to explore mechanisms of intervention effects on cognitive functioning. MBSR participants reported significantly greater improvement on the AFI total score compared to ES participants at T2 (d = 0.83, p = 0.001) and T3 (d = 0.55, p = 0.021). MBSR also significantly outperformed ES on most AFI subscales, although both groups improved over time. MBSR produced greater Stroop accuracy rates relative to ES at T2 (r = 0.340, p = 0.005) and T3 (r = 0.280, p = 0.030), with improved accuracy over time only for the MBSR group. There were no significant differences in Stroop reaction time between groups. Improvements in mindfulness mediated the effect of group (e.g., MBSR vs. ES) on AFI total score at T2 and T3. Additional randomized trials with more comprehensive cognitive measures are warranted to definitively assess the efficacy of MBSR for CRCI. This pilot study has important implications for all cancer survivors as it is the first published trial to show that MBSR offers robust and durable improvements in CRCI.

Honest, Open, Proud for adolescents with mental illness: pilot randomized controlled trial.

Science.gov (United States)

Mulfinger, Nadine; Müller, Sabine; Böge, Isabel; Sakar, Vehbi; Corrigan, Patrick W; Evans-Lacko, Sara; Nehf, Luise; Djamali, Julia; Samarelli, Anna; Kempter, Michael; Ruckes, Christian; Libal, Gerhard; Oexle, Nathalie; Noterdaeme, Michele; Rüsch, Nicolas

2018-06-01

Due to public stigma or self-stigma and shame, many adolescents with mental illness (MI) struggle with the decision whether to disclose their MI to others. Both disclosure and nondisclosure are associated with risks and benefits. Honest, Open, Proud (HOP) is a peer-led group program that supports participants with disclosure decisions in order to reduce stigma's impact. Previously, HOP had only been evaluated among adults with MI. This two-arm pilot randomized controlled trial included 98 adolescents with MI. Participants were randomly assigned to HOP and treatment as usual (TAU) or to TAU alone. Outcomes were assessed pre (T0/baseline), post (T1/after the HOP program), and at 3-week follow-up (T2/6 weeks after T0). Primary endpoints were stigma stress at T1 and quality of life at T2. Secondary outcomes included self-stigma, disclosure-related distress, empowerment, help-seeking intentions, recovery, and depressive symptoms. The trial is registered on ClinicalTrials (NCT02751229; http://www.clinicaltrials.gov). Compared to TAU, adolescents in the HOP program showed significantly reduced stigma stress at T1 (d = .92, p self-stigma, disclosure-related distress, secrecy, help-seeking intentions, attitudes to disclosure, recovery, and depressive symptoms. Effects at T1 remained stable or improved further at follow-up. In a limited economic evaluation HOP was cost-efficient in relation to gains in quality of life. As HOP is a compact three-session program and showed positive effects on stigma and disclosure variables as well as on symptoms and quality of life, it could help to reduce stigma's negative impact among adolescents with MI. © 2017 Association for Child and Adolescent Mental Health.

Effect of cryotherapy after elbow arthrolysis: a prospective, single-blinded, randomized controlled study.

Science.gov (United States)

Yu, Shi-yang; Chen, Shuai; Yan, He-de; Fan, Cun-yi

2015-01-01

To investigate the effect of cryotherapy after elbow arthrolysis on elbow pain, blood loss, analgesic consumption, range of motion, and long-term elbow function. Prospective, single-blinded, randomized controlled study. University hospital. Patients (N=59; 27 women, 32 men) who received elbow arthrolysis. Patients were randomly assigned into a cryotherapy group (n=31, cryotherapy plus standard care) or a control group (n=28, standard care). Elbow pain at rest and in motion were measured using a visual analog scale (VAS) on postoperative day (POD) 1 to POD 7 and at 2 weeks and 3 months after surgery. Blood loss and analgesic consumption were recorded postoperatively. Elbow range of motion (ROM) was measured before surgery and on POD 1, POD 7, and 3 months after surgery. The Mayo Elbow Performance Score (MEPS) was evaluated preoperatively and 3 months postoperatively. VAS scores were significantly lower in the cryotherapy group during the first 7 PODs, both at rest and in motion (Pcryotherapy group than the control group for pain relief (P.05). Cryotherapy is effective in relieving pain and reducing analgesic consumption for patients received elbow arthrolysis. The application of cryotherapy will not affect blood loss, ROM, or elbow function. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

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

Science.gov (United States)

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

2013-03-01

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

Whole-body vibration training improves balance control and sit-to-stand performance among middle-aged and older adults: a pilot randomized controlled trial

OpenAIRE

Ko, Ming-Chen; Wu, Long-Shan; Lee, Sangwoo; Wang, Chien-Chun; Lee, Po-Fu; Tseng, Ching-Yu; Ho, Chien-Chang

2017-01-01

Background Aging is associated with decreased balance, which increases falling risk. The objective of the current study was to determine the feasibility and effects of whole-body vibration (WBV) training on knee extensor muscle power, limits of stability, and sit-to-stand performance among community-dwelling middle-aged and older adults in the United States. Methods A randomized pilot study with participant blinding was conducted. Feasibility outcomes included recruitment and compliance rate....

Patent foramen ovale and asymptomatic brain lesions in military fighter pilots.

Science.gov (United States)

Kang, Kyung Wook; Kim, Joon-Tae; Choi, Won-Ho; Park, Won-Ju; Shin, Young Ho; Choi, Kang-Ho

2014-10-01

Previous studies have reported higher incidence of white matter lesions (WMLs) in military pilots. The anti-gravity straining maneuver, which fighter military pilots perform numerously during a flight is identical to the valsalva maneuver. We sought to investigate the prevalence of right-to-left shunt (RLS) associated with WMLs in military pilots. A prospective study was performed involving military pilots who visited the Airomedical Center. The pilots underwent brain magnetic resonance imaging (MRI) scan and transcranial Doppler (TCD) with intravenous injection of agitated saline solution for the detection of RLS. Periventricular WMLs (PVWMLs) on MRI were graded using Fazeka's scale, and deep WMLs (DWMLs) were graded using Scheltens's scale. This study included 81 military pilots. RLS on TCD was observed less frequently in non-fighter pilots than in fighter pilots (35.5% vs. 64.5%, p=0.011). Fighter pilot was an independently associated factor with RLS on the TCD. DWMLs were independently associated with RLSs through a patent foramen ovale (PFO) (OR 3.507, 95% CI 1.223-10.055, p=0.02). The results suggest that DWMLs in military pilots may significantly be associated with RLS via PFO. Additional investigations are warranted. Copyright © 2014 Elsevier B.V. All rights reserved.

Feasibility and acceptability of a beverage intervention for Hispanic adults: a protocol for a pilot randomized controlled trial.

Science.gov (United States)

Morrill, Kristin E; Aceves, Benjamin; Valdez, Luis A; Thomson, Cynthia A; Hakim, Iman A; Bell, Melanie L; Martinez, Jessica A; Garcia, David O

2018-02-09

In the U.S., Hispanics have among the highest rates of overweight and obesity when compared to other racial/ethnic groups placing them at a greater risk for obesity-related disease. Identifying intervention strategies to reduce caloric intake and/or improve cardiometabolic health in Hispanics is critical to reducing morbidity and mortality among this large and growing population. Evidence exists to support diet-specific behavioral interventions, including beverage modifications, in reducing obesity-related health risks. However, the acceptability and feasibility of a beverage intervention in obese Hispanic adults has not been robustly evaluated. The objective of this pilot study is to assess the feasibility and acceptability of a randomized, controlled beverage intervention in 50 obese Hispanic adults ages 18-64 over 8-weeks. Eligible participants were obese (30-50.0 kg/m 2 ), between the ages 18-64, self-identified as Hispanic, and were able to speak, read, and write in either English and/or Spanish. Study recruitment was completed August 2017. Upon the completion of baseline assessments, participants will be randomized to either Mediterranean lemonade, Green Tea, or flavored water control. After completing a 2-week washout period, participants will be asked to consume 32 oz. per day of study beverage for 6-weeks while avoiding all other sources of tea, lemonade, citrus, juice, and other sweetened beverages; water is permissible. Primary outcomes will be recruitment, retention, and acceptability of the intervention strategies. Our study will also evaluate participant-reported tolerance and as an exploratory aim, assess safety/toxicity-related to renal and/or liver function. Fasting blood samples will be collected at baseline and 8-weeks to assess the primary efficacy outcomes: total cholesterol, high-density lipoprotein (HDL), and low-density lipoprotein (LDL). Secondary outcomes include fasting glucose, hemoglobin A1c (HbA1c), and high-sensitivity C

Does interscalene catheter placement with stimulating catheters improve postoperative pain or functional outcome after shoulder surgery? A prospective, randomized and double-blinded trial

NARCIS (Netherlands)

Stevens, Markus F.; Werdehausen, Robert; Golla, Elisabeth; Braun, Sebastian; Hermanns, Henning; Ilg, Ansgar; Willers, Reinhardt; Lipfert, Peter

2007-01-01

BACKGROUND: In this prospective, randomized, double-blind trial we investigated the use of stimulating catheters in patients during and after shoulder surgery; functional improvement being the primary outcome measurement. METHODS: After eliciting an adequate muscular twitch at

A prospective randomized peri- and post-operative comparison of the minimally invasive anterolateral approach versus the lateral approach

OpenAIRE

Stefan Landgraeber; Henning Quitmann; Sebastian Güth; Marcel Haversath; Wojciech Kowalczyk; Andrés Kecskeméthy; Hansjörg Heep; Marcus Jäger

2013-01-01

There is still controversy as to whether minimally invasive total hip arthroplasty enhances the postoperative outcome. The aim of this study was to compare the outcome of patients who underwent total hip replacement through an anterolateral minimally invasive (MIS) or a conventional lateral approach (CON). We performed a randomized, prospective study of 75 patients with primary hip arthritis, who underwent hip replacement through the MIS (n=36) or CON (n=39) approach. The Western Ontario and ...

Peyton's four-step approach for teaching complex spinal manipulation techniques - a prospective randomized trial.

Science.gov (United States)

Gradl-Dietsch, Gertraud; Lübke, Cavan; Horst, Klemens; Simon, Melanie; Modabber, Ali; Sönmez, Tolga T; Münker, Ralf; Nebelung, Sven; Knobe, Matthias

2016-11-03

The objectives of this prospective randomized trial were to assess the impact of Peyton's four-step approach on the acquisition of complex psychomotor skills and to examine the influence of gender on learning outcomes. We randomly assigned 95 third to fifth year medical students to an intervention group which received instructions according to Peyton (PG) or a control group, which received conventional teaching (CG). Both groups attended four sessions on the principles of manual therapy and specific manipulative and diagnostic techniques for the spine. We assessed differences in theoretical knowledge (multiple choice (MC) exam) and practical skills (Objective Structured Practical Examination (OSPE)) with respect to type of intervention and gender. Participants took a second OSPE 6 months after completion of the course. There were no differences between groups with respect to the MC exam. Students in the PG group scored significantly higher in the OSPE. Gender had no additional impact. Results of the second OSPE showed a significant decline in competency regardless of gender and type of intervention. Peyton's approach is superior to standard instruction for teaching complex spinal manipulation skills regardless of gender. Skills retention was equally low for both techniques.

Randomized prospective study of olecranon fracture fixation: cable pin system versus tension band wiring.

Science.gov (United States)

Liu, Q-H; Fu, Z-G; Zhou, J-L; Lu, T; Liu, T; Shan, L; Liu, Y; Bai, L

2012-01-01

This prospective, randomized study compared the effectiveness of the cable pin system (CPS) versus tension band wiring (TBW) for olecranon fracture fixation. Patients with acute transverse or slight oblique olecranon fractures were randomly divided into two groups: one fixed by CPS and the other by TBW. Clinical outcome data were collected and analysed following a mean duration of 21 months. The mean ± SD fracture healing time was significantly shorter in the CPS group (n = 30; 9.73 ± 2.02 weeks) compared with the TBW group (n = 32; 11.13 ± 2.21 weeks). One patient in the CPS group and seven patients in the TBW group experienced postoperative complications; this difference was statistically significant. The mean ± SD Mayo Elbow Performance Score in the CPS group was significantly higher (88.67 ± 6.42) than that in the TBW group (80.78 ± 11.99). Logistic regression analysis showed an association between fixation method and fracture healing time, complications and elbow function. Internal fixation by CPS is an effective method for olecranon fracture and is associated with a shorter healing time, fewer complications and better function than TBW.

Randomized, Prospective Comparison of Ursodeoxycholic Acid for the Prevention of Gallstones after Sleeve Gastrectomy.

Science.gov (United States)

Adams, Lindsay B; Chang, Craig; Pope, Janet; Kim, Yeonsoo; Liu, Pei; Yates, Amy

2016-05-01

Several studies have examined the role of ursodeoxycholic acid (UDCA) for the prevention of cholelithiasis (gallstones) following rapid weight loss from restrictive diets, vertical band gastroplasty, and Roux-en-Y gastric bypass. However, to date, there have been no prospective, controlled studies examining the role of UDCA for the prevention of gallstones following sleeve gastrectomy (SG). This study was conducted to identify the effectiveness of UDCA for prevention of gallstones after SG. Following SG, eligible patients were randomized to a control group who did not receive UDCA treatment or to a group who were prescribed 300 mg UDCA twice daily for 6 months. Gallbladder ultrasounds were performed preoperatively and at 6 and 12 months postoperatively. Patients with positive findings preoperatively were excluded from the study. Compliance with UDCA was assessed. Between December 2011 and April 2013, 37 patients were randomized to the UDCA treatment arm and 38 patients were randomized to no treatment. At baseline, the two groups were similar. At 6 months, the UDCA group had a statistically significant lower incidence of gallstones (p = 0.032). Analysis revealed no significant difference in gallstones between the two groups at 1 year (p = 0.553 and p = 0.962, respectively). The overall gallstone formation rate was 29.8%. The incidence of gallstones is higher than previously estimated in SG patients. UDCA significantly lowers the gallstone formation rate at 6 months postoperatively.

Prospective, Randomized, Multinational Study of Prostatic Urethral Lift Versus Transurethral Resection of the Prostate

DEFF Research Database (Denmark)

Sønksen, Jens; Barber, Neil J; Speakman, Mark J

2015-01-01

BACKGROUND: Transurethral resection of the prostate (TURP) is considered the gold standard for male lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). However, TURP may lead to sexual dysfunction and incontinence, and has a long recovery period. Prostatic urethral...... lift (PUL) is a treatment option that may overcome these limitations. OBJECTIVE: To compare PUL to TURP with regard to LUTS improvement, recovery, worsening of erectile and ejaculatory function, continence and safety (BPH6). DESIGN, SETTING, AND PARTICIPANTS: Prospective, randomized, controlled trial...... at 10 European centers involving 80 men with BPH LUTS. INTERVENTION: PUL or TURP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The BPH6 responder endpoint assesses symptom relief, quality of recovery, erectile function preservation, ejaculatory function preservation, continence preservation...

A randomized, prospective cross-over trial comparing methylene blue-directed biopsy and conventional random biopsy for detecting intestinal metaplasia and dysplasia in Barrett's esophagus.

Science.gov (United States)

Ragunath, K; Krasner, N; Raman, V S; Haqqani, M T; Cheung, W Y

2003-12-01

The value of methylene blue-directed biopsies (MBDB) in detecting specialized intestinal metaplasia and dysplasia in Barrett's esophagus remains unclear. The aim of this study was to compare the accuracy of MBDB with random biopsy in detecting intestinal metaplasia and dysplasia in patients with Barrett's esophagus. A prospective, randomized, cross-over trial was undertaken to compare MBDB with random biopsy in patients with Barrett's esophagus segments 3 cm or more in length without macroscopic evidence of dysplasia or cancer. Dysplasia was graded as: indefinite for dysplasia, low-grade dysplasia, high-grade dysplasia, or carcinoma, and was reported in a blinded fashion. Fifty-seven patients were recruited, 44 of whom were male. A total of 1,269 biopsies were taken (MBDB-651, random biopsie-618). Analysis of the results by per-biopsy protocol showed that the MBDB technique diagnosed significantly more specialized intestinal metaplasia (75 %) compared to the random biopsy technique (68 %; P = 0.032). The sensitivity and specificity rates of MBDB for diagnosing specialized intestinal metaplasia were 91 % (95 % CI, 88 - 93 %) and 43 % (95 % CI, 36 - 51 %), respectively. The sensitivity and specificity rates of MBDB for diagnosing dysplasia or carcinoma were 49 % (95 % CI, 38 - 61 %) and 85 % (95 % CI, 82 - 88 %), respectively. There were no significant differences in the diagnosis of dysplasia and carcinoma - MBDB 12 %, random biopsy 10 %. The methylene blue staining pattern appeared to have an influence on the detection of specialized intestinal metaplasia and dysplasia/carcinoma. Dark blue staining was associated with increased detection of specialized intestinal metaplasia (P biopsies. Although MBDB prolongs the endoscopy procedure slightly, it is a safe and well-tolerated procedure. Further clinical studies on the MBDB technique exclusively in endoscopically normal dysplastic Barrett's esophagus are needed.

Effect of Mozart music on heel prick pain in preterm infants: a pilot randomized controlled trial

Directory of Open Access Journals (Sweden)

Cristina Cavaiuolo

2015-02-01

Full Text Available Objective: The aim of this pilot study was to determine the effect of music by Mozart on heel prick procedural pain in premature infants.Background: Painful procedures are routinely performed in the setting of neonatal intensive care unit (NICU. Pain may exert short- and long-term deleterious effects on premature babies. Many non-pharmacological interventions have been proven efficacious for blunting neonatal pain.Study design: Randomized, controlled trial.Methods: The study was carried out in the NICU of the “G. Rummo” Hospital in Benevento, Italy. The sample consisted of 42 preterm infants, with no hearing loss or significant cerebral lesions on cranial ultrasound. They were randomized to receive heel lance during a music condition or a no-music control condition. We set strict criteria for selecting and delivering the music. Baseline and postprocedural heart rate and transcutaneous oxygen saturation were manually recorded. The Premature Infant Pain Profile (PIPP score was used to measure the behavioral response to prick. An unpaired t-test was performed for the intergroup comparisons.Results: There were significant differences between groups on heart rate increase, oxygen saturation reduction and PIPP score following the procedure.Conclusions: Listening to Mozart music during heel prick is a simple and inexpensive tool for pain alleviating in preterm stable neonates.

Comparison of Tension-Band Wiring With the Cable Pin System in Patella Fractures: A Randomized Prospective Study.

Science.gov (United States)

Tian, Qing-xian; Hai, Yong; Du, Xin-ru; Xu, Zi-yu; Lu, Tie; Shan, Lei; Liu, Yang; Zhou, Jun-lin

2015-12-01

To compare the outcome of tension-band wiring (TBW) with the cable pin system (CPS) for transverse fractures of the patella. Randomized prospective study. Academic Level I trauma center. From February 2008 to December 2011, 73 consecutive patients with transverse fractures of the patella were prospectively enrolled in this study. The patients were randomly divided into 2 groups: one group was treated using the CPS, and the other group was treated using the modified TBW. The clinical outcome assessment included analyses of the radiographic images, the modified Hospital for Special Surgery scoring system, and complications. The follow-up time ranged from 12 to 29 months. All fractures healed, with a union rate of 100%. The fracture healing time was significantly shorter in the CPS group (8.51 ± 2.59 weeks, n = 34) compared with the TBW group (11.79 ± 3.04 weeks, n = 39). Postoperative complications in the CPS and TBW groups were observed in 1 and 9 patients, respectively, a difference that was statistically significant. The mean Hospital for Special Surgery score for the CPS group (90.53 ± 5.19 points) was significantly higher than that for the TBW group (81.36 ± 12.71 points). The CPS is a viable option for transverse fractures of the patella and is associated with a shorter healing time, fewer complications, and better function than TBW. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Early physical training and psycho-educational intervention for patients undergoing coronary artery bypass grafting. The SheppHeart randomized 2 × 2 factorial clinical pilot trial

DEFF Research Database (Denmark)

Højskov, Ida E; Moons, Philip; Hansen, Niels V

2015-01-01

BACKGROUND: Patients undergoing coronary artery bypass graft surgery often experience a range of problems and symptoms such as immobility, pain and insufficient sleep. Results from trials investigating testing in-hospital physical exercise or psychological intervention have been promising. However......, no randomized clinical trials have tested a comprehensive rehabilitation programme consisting of both physical exercise and psycho-education in the early rehabilitation phase. AIMS: The aims of the present SheppHeart pilot randomized clinical trial were to evaluate the feasibility of patient recruitment......, patient acceptance of the intervention, safety and tolerability of the intervention. METHODS AND DESIGN: Sixty patients admitted for coronary artery bypass graft were randomized 1:1:1:1 to: 1) physical exercise plus usual care, or 2) psycho-educational intervention plus usual care, or 3) physical exercise...

A pilot randomized, controlled trial of metformin versus insulin in women with type 2 diabetes mellitus during pregnancy.

Science.gov (United States)

Refuerzo, Jerrie S; Gowen, Rose; Pedroza, Claudia; Hutchinson, Maria; Blackwell, Sean C; Ramin, Susan

2015-02-01

Few studies support oral diabetic treatment in pregnant women with type 2 diabetes mellitus (T2DM). The objective of this study was to compare the effects of metformin versus insulin on achieving glycemic control and improving maternal and neonatal outcomes in pregnant women with T2DM. A pilot randomized, controlled trial was conducted of metformin versus insulin for the treatment of T2DM during pregnancy. The primary outcome was glycemic control measured with hemoglobin A1c metformin and 11 received insulin. All women in both groups achieved glycemic control by delivery (HgbA1c: metformin 5.96 ± 5.88 vs. insulin 6.34 ± 0.92%). There were similar rates of cesarean delivery, birth weights, neonatal intensive care unit admissions, respiratory distress syndrome, and neonatal dextrose treatment between groups. There was one case of fetal macrosomia in the insulin group, one case of shoulder dystocia in the metformin group and no cases of failed metformin therapy. In this pilot study, glycemic control was achieved in women who received metformin and insulin. Larger studies are needed to determine whether metformin can be considered a reasonable alternative to insulin in pregnant women with T2DM. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Improving Prospective Memory in Persons With Parkinson Disease: A Randomized Controlled Trial.

Science.gov (United States)

Foster, Erin R; McDaniel, Mark A; Rendell, Peter G

2017-05-01

Prospective memory (PM) is essential for productive and independent living and necessary for compliance with prescribed health behaviors. Parkinson disease (PD) can cause PM deficits that are associated with activity limitations and reduced quality of life. Forming implementation intentions (IIs) is an encoding strategy that may improve PM in this population. To determine the effect of IIs on PM performance in PD. This was a laboratory-based randomized controlled trial. Participants with mild to moderate PD without dementia (n = 62) performed a computerized PM test (Virtual Week) under standard instructions. One week later they were randomly allocated to perform it again while using either IIs or a rehearsal (RR) encoding strategy. PM performance was better with the use of both strategies relative to standard instructions. This effect was larger for tasks with event-based compared with time-based cues. In addition, IIs resulted in a larger effect than RR for the nonrepeated tasks. Strategies that support full encoding of PM cues and actions can improve PM performance among people with PD, particularly for tasks with cues that are readily available in the environment. IIs may be more effective than RR for nonrepeated tasks, but this finding warrants verification. Future work should address transfer of strategy use from the laboratory to everyday life. Targeted strategies to manage PM impairment could improve function and quality of life and significantly affect clinical care for people with PD.

A prospective randomized study of use of drain versus no drain after burr-hole evacuation of chronic subdural hematoma.

Science.gov (United States)

Singh, Amit Kumar; Suryanarayanan, Bhaskar; Choudhary, Ajay; Prasad, Akhila; Singh, Sachin; Gupta, Laxmi Narayan

2014-01-01

Chronic subdural hematoma (CSDH) recurs after surgical evacuation in 5-30% of patients. Inserting subdural drain might reduce the recurrence rate, but is not commonly practiced. There are few prospective studies to evaluate the effect of subdural drains. A prospective randomized study to investigate the effect of subdural drains in the on recurrence rates and clinical outcome following burr-hole drainage (BHD) of CSDH was undertaken. During the study period, 246 patients with CSDH were assessed for eligibility. Among 200 patients fulfilling the eligibility criteria, 100 each were assigned to "drain group" (drain inserted into the subdural space following BHD) and "without drain group" (subdural drain was not inserted following BHD) using random allocation software. The primary end point was recurrence needing re-drainage up to a period of 6 months from surgery. Recurrence occurred in 9 of 100 patients with a drain, and 26 of 100 patients in without drain group (P = 0.002). The mortality was 5% in patients with drain and 4% in patients without drain group (P = 0.744). The medical and surgical complications were comparable between the two study groups. Use of a subdural drain after burr-hole evacuation of a CSDH reduces the recurrence rate and is not associated with increased complications.

Using brothel leadership to promote condom use among brothel-based female sex workers in Abuja, Nigeria: study protocol for a cluster randomized pilot trial

Directory of Open Access Journals (Sweden)

Uchenna Okafor

2017-02-01

Full Text Available Abstract Background The HIV prevalence among female populations involved in sex work in Nigeria has heightened interest in HIV prevention programming for this sub-population with brothel-based female sex workers (BB FSWs having a prevalence of 27.4%, six times higher than the prevalence in the general population. Methods/design The clusters in the randomized pilot trial will be brothels and female sex workers (FSWs residing in the brothels will be the participants of the study. The participants will receive free condom distribution as well as HIV prevention messages on condom use and negotiation skills to increase self-efficacy in handling social and gender power plays within their environment. Twelve brothels will be randomized into experimental and control conditions with a minimum total sample size of 200 participants. Recruitment of participants will be carried out from within the brothels. The control condition will receive a standard intervention consisting of a minimum of six interactive sessions with peer educators (PE engaging their peers through group discussions and one on one interaction using pre-designed HIV prevention messages. The experimental condition will receive the standard intervention as well as interactive sessions with the brothel leadership (chairladies and brothel managers to facilitate consistent condom use and appropriate condom use policies, conditions, and messaging. Both interventions will be delivered over a maximum period of 16 weeks, and male and female condoms will be distributed during the intervention. Quantitative assessments will be carried out at baseline and at 16 weeks follow-up, and the pilot findings will inform feasibility of and sample size estimation for a phase III trial. The primary outcomes measured are recruitment rate attrition rate and adherence to the intervention. Consistent condom use outcomes by FSWs within the brothel with all partner types and enhanced self-efficacy for condom

Using brothel leadership to promote condom use among brothel-based female sex workers in Abuja, Nigeria: study protocol for a cluster randomized pilot trial.

Science.gov (United States)

Okafor, Uchenna; Crutzen, Rik; Okekearu, Ifeanyi; Adebajo, Sylvia; Uzoh, Adaora; Awo, Egbe Aneotah; Chima, Chukwuemeka; Agwagwa, Ogechukwu; van den Borne, Bart

2017-01-01

The HIV prevalence among female populations involved in sex work in Nigeria has heightened interest in HIV prevention programming for this sub-population with brothel-based female sex workers (BB FSWs) having a prevalence of 27.4%, six times higher than the prevalence in the general population. The clusters in the randomized pilot trial will be brothels and female sex workers (FSWs) residing in the brothels will be the participants of the study. The participants will receive free condom distribution as well as HIV prevention messages on condom use and negotiation skills to increase self-efficacy in handling social and gender power plays within their environment. Twelve brothels will be randomized into experimental and control conditions with a minimum total sample size of 200 participants. Recruitment of participants will be carried out from within the brothels. The control condition will receive a standard intervention consisting of a minimum of six interactive sessions with peer educators (PE) engaging their peers through group discussions and one on one interaction using pre-designed HIV prevention messages. The experimental condition will receive the standard intervention as well as interactive sessions with the brothel leadership (chairladies and brothel managers) to facilitate consistent condom use and appropriate condom use policies, conditions, and messaging. Both interventions will be delivered over a maximum period of 16 weeks, and male and female condoms will be distributed during the intervention. Quantitative assessments will be carried out at baseline and at 16 weeks follow-up, and the pilot findings will inform feasibility of and sample size estimation for a phase III trial. The primary outcomes measured are recruitment rate attrition rate and adherence to the intervention. Consistent condom use outcomes by FSWs within the brothel with all partner types and enhanced self-efficacy for condom negotiation with all partner types will be the primary

Symptomatic treatment (ibuprofen or antibiotics (ciprofloxacin for uncomplicated urinary tract infection? - Results of a randomized controlled pilot trial

Directory of Open Access Journals (Sweden)

Wegscheider Karl

2010-05-01

Full Text Available Abstract Background Uncomplicated lower urinary tract infections (UTI are usually treated with antibiotics. However, there is little evidence for alternative therapeutic options. This pilot study was set out 1 to make a rough estimate of the equivalence of ibuprofen and ciprofloxacin for uncomplicated urinary tract infection with regard to symptom resolution, and 2 to demonstrate the feasibility of a double-blind, randomized controlled drug trial in German general practices. Methods We performed a double-blind, randomized controlled pilot trial in 29 German general practices. Eighty otherwise healthy women aged 18 to 85 years, presenting with at least one of the main UTI symptoms dysuria and frequency and without any complicating factors, were randomly assigned to receive either ibuprofen 3 × 400 mg oral or ciprofloxacin 2 × 250 mg (+1 placebo oral, both for three days. Intensity of main symptoms - dysuria, frequency, low abdominal pain - was recorded at inclusion and after 4, 7 and 28 days, scoring each symptom from 0 (none to 4 (very strong. The primary endpoint was symptom resolution on Day 4. Secondary outcomes were the burden of symptoms on Days 4 and 7 (based on the sum score of all symptoms, symptom resolution on Day 7 and frequency of relapses. Equivalence margins for symptom burden on Day 4 were pre-specified as +/- 0.5 sum score points. Data analysis was done by intention to treat and per protocol. Randomization was carried out on patient level by computer programme in blocks of six. Results Seventy-nine patients were analyzed (ibuprofen n = 40, ciprofloxacin n = 39. On Day 4, 21/36 (58.3% of patients in the ibuprofen-group were symptom-free versus 17/33 (51.5% in the ciprofloxacin-group. On Day 4, ibuprofen patients reported fewer symptoms in terms of total sum score (1; SD 1,42 than ciprofloxacin patients (1,3; SD 1,9, difference -0,33 (95% CI (-1,13 to +0,47, PP (per protocol analysis. During Days 0 and 9, 12/36 (33% of patients

Mobile application as a prenatal education and engagement tool: A randomized controlled pilot.

Science.gov (United States)

Ledford, Christy J W; Canzona, Mollie Rose; Cafferty, Lauren A; Hodge, Joshua A

2016-04-01

Research has shown that mobile applications provide a powerful alternative to traditional paper diaries; however, little data exists in comparing apps to the traditional mode of paper as a patient education and engagement tool in the clinical setting. This study was designed to compare the effectiveness of a mobile app versus a spiral-notebook guide throughout prenatal care. This randomized (n=173) controlled pilot was conducted at an East Coast community hospital. Chi-square and repeated-measures analysis of variance was used to test intervention effects in the sample of 127 pregnant mothers who completed their prenatal care in the healthcare system. Patients who were distributed the mobile application used the tool to record information about pregnancy more frequently (p=.04) and developed greater patient activation (p=.02) than patients who were distributed notebooks. No difference was detected on interpersonal clinical communication. A mobile application successfully activated a patient population in which self-management is a critical factor. This study shows that mobile apps can prompt greater use and result in more activated patients. Findings may be translated to other patient populations who receive recurring care for chronic disease. Published by Elsevier Ireland Ltd.

A pilot randomized trial teaching mindfulness-based stress reduction to traumatized youth in foster care.

Science.gov (United States)

Jee, Sandra H; Couderc, Jean-Philippe; Swanson, Dena; Gallegos, Autumn; Hilliard, Cammie; Blumkin, Aaron; Cunningham, Kendall; Heinert, Sara

2015-08-01

This article presents a pilot project implementing a mindfulness-based stress reduction program among traumatized youth in foster and kinship care over 10 weeks. Forty-two youth participated in this randomized controlled trial that used a mixed-methods (quantitative, qualitative, and physiologic) evaluation. Youth self-report measuring mental health problems, mindfulness, and stress were lower than anticipated, and the relatively short time-frame to teach these skills to traumatized youth may not have been sufficient to capture significant changes in stress as measured by electrocardiograms. Main themes from qualitative data included expressed competence in managing ongoing stress, enhanced self-awareness, and new strategies to manage stress. We share our experiences and recommendations for future research and practice, including focusing efforts on younger youth, and using community-based participatory research principles to promote engagement and co-learning. CLINICALTRIALS.GOV: Protocol Registration System ID NCT01708291. Copyright © 2015 Elsevier Ltd. All rights reserved.

27-GAUGE VITRECTOMY WOUND INTEGRITY: A Randomized Pilot Study Comparing Angled Versus Straight Entry in Fluid-Filled Vitrectomized Eyes.

Science.gov (United States)

Khan, M Ali; Durrani, Alia K; Hsu, Jason; Regillo, Carl D

2018-04-01

To compare clinical outcomes using angled versus straight trocar insertion during 27-gauge pars plana vitrectomy for epiretinal membrane. Pilot randomized controlled trial. Thirty eyes of 30 patients undergoing 27-gauge pars plana vitrectomy with membrane peeling for epiretinal membrane were randomized 1:1 to receive angled or straight trocar insertion. Intraocular pressure (IOP) and postoperative wound-related complications were compared. Fifteen eyes were randomized to each the angled and straight incision groups. No significant difference in phakic status (P = 0.71) or preoperative IOP (15.1 ± 3.4 vs. 14.6 ± 3.0 mmHg, P = 0.67) existed between groups. On postoperative Day 1, eyes in the straight group had lower IOP compared with the angled group (11.8 ± 3.9 vs. 15.3 ± 5.2 mmHg, P = 0.04) and a relative decrease in IOP compared with preoperative values (11.8 ± 3.9 vs. 15.1 ± 3.4 mmHg, P straight group) and serous choroidal detachment (1 eye, angled group). Eyes with straight incisions had transiently lower IOP on postoperative Day 1, possibly suggestive of subclinical wound leak in the very early postoperative period. Overall, rates of hypotony and sclerotomy-related complications were similarly low between wound construction strategies.

Grappling with the future: The messiness of pilot implementation in information systems design.

Science.gov (United States)

Hertzum, Morten; Manikas, Maria Ie; Á Torkilsheyggi, Arnvør

2017-06-01

Pilot implementation is a method for avoiding unintended consequences of healthcare information systems. This study investigates how learning from pilot implementations is situated, messy, and therefore difficult. We analyze two pilot implementations by means of observation and interviews. In the first pilot implementation, the involved porters saw their improved overview of pending patient transports as an opportunity for more self-organization, but this opportunity hinged on the unclear prospects of extending the system with functionality for the porters to reply to transport requests. In the second pilot implementation, the involved paramedics had to print the data they had entered into the system because it had not yet been integrated with the electronic patient record. This extra work prolonged every dispatch and influenced the paramedics' experience of the entire system. We discuss how pilot implementations, in spite of their realism, leave room for uncertainty about the implications of the new system.

Thermal welding versus cold knife tonsillectomy: A prospective randomized study

Directory of Open Access Journals (Sweden)

Metin Yilmaz

2012-05-01

Full Text Available This is a prospective randomized study conducted in a group of children who underwent two methods of tonsillectomy: thermal welding or cold knife tonsillectomy. Parameters, such as postoperative pain scores, intraoperative blood loss, operation time, and postoperative bleeding rates, were analyzed to find out which technique is better. Ninety-one children (aged between 2 years and 13 years with recurrent tonsillitis, obstructive sleep apnea syndrome, or both were included in the study. According to the type of tonsillectomy procedure, the patients were divided into two groups: cold knife and thermal welding procedure. The two groups were compared on the basis of postoperative pain scores, intraoperative blood loss, operation time, and postoperative bleeding. Fifty-seven patients underwent thermal welding tonsillectomy and 34 had cold knife tonsillectomy. The mean pain score in thermal welding group was significantly lower (p<0.001. There was no remarkable blood loss intraoperatively in the thermal welding procedure. The operation time was not significantly different between two groups. No postoperative bleeding was encountered in the thermal welding group. Compared with the cold knife technique, thermal welding was found to be a relatively new and safe technique for tonsillectomy as it results in significantly less postoperative pain and no remarkable blood loss.

Security scheme in IMDD-OFDM-PON system with the chaotic pilot interval and scrambling

Science.gov (United States)

Chen, Qianghua; Bi, Meihua; Fu, Xiaosong; Lu, Yang; Zeng, Ran; Yang, Guowei; Yang, Xuelin; Xiao, Shilin

2018-01-01

In this paper, a random chaotic pilot interval and permutations scheme without any requirement of redundant sideband information is firstly proposed for the physical layer security-enhanced intensity modulation direct detection orthogonal frequency division multiplexing passive optical network (IMDD-OFDM-PON) system. With the help of the position feature of inserting the pilot, a simple logistic chaos map is used to generate the random pilot interval and scramble the chaotic subcarrier allocation of each column pilot data for improving the physical layer confidentiality. Due to the dynamic chaotic permutations of pilot data, the enhanced key space of ∼103303 is achieved in OFDM-PON. Moreover, the transmission experiment of 10-Gb/s 16-QAM encrypted OFDM data is successfully demonstrated over 20-km single-mode fiber, which indicates that the proposed scheme not only improves the system security, but also can achieve the same performance as in the common IMDD-OFDM-PON system without encryption scheme.

Use of a Data-Linked Weather Information Display and Effects on Pilot Navigation Decision Making in a Piloted Simulation Study

Science.gov (United States)

Yuchnovicz, Daniel E.; Novacek, Paul F.; Burgess, Malcolm A.; Heck, Michael L.; Stokes, Alan F.

2001-01-01

This study provides recommendations to the FAA and to prospective manufacturers based on an exploration of the effects of data link weather displays upon pilot decision performance. An experiment was conducted with twenty-four current instrument rated pilots who were divided into two equal groups and presented with a challenging but realistic flight scenario involving weather containing significant embedded convective activity. All flights were flown in a full-mission simulation facility within instrument meteorological conditions. The inflight weather display depicted NexRad images, graphical METARs and textual METARs. The objective was to investigate the potential for misuse of a weather display, and incorporate recommendations for the design and use of these displays. The primary conclusion of the study found that the inflight weather display did not improve weather avoidance decision making. Some of the reasons to support this finding include: the pilot's inability to easily perceive their proximity to the storms, increased workload and difficulty in deciphering METAR textual data. The compelling nature of a graphical weather display caused many pilots to reduce their reliance on corroborating weather information from other sources. Minor changes to the weather display could improve the ability of a pilot to make better decisions on hazard avoidance.

Influence of the pneumatic tourniquet on patella tracking in total knee arthroplasty: a prospective randomized study in 100 patients

DEFF Research Database (Denmark)

Husted, Henrik; Toftgaard Jensen, T

2005-01-01

One hundred consecutive patients with osteoarthritis of the knee joint and scheduled for primary total knee arthroplasty performed in a bloodless field were prospectively randomized to have the tourniquet inflated on either straight leg or maximally flexed knee. There was no difference in the num...... deflation led to better patella tracking and saved 5 (31%) of 16 releases with no difference between groups. We recommend tourniquet deflation and reevaluation of patella tracking before performing lateral release in patellar maltracking....

Ketamine as an Adjunct to Postoperative Pain Management in Opioid Tolerant Patients After Spinal Fusions: A Prospective Randomized Trial

OpenAIRE

Urban, Michael K.; Ya Deau, Jacques T.; Wukovits, Barbara; Lipnitsky, Jane Y.

2007-01-01

Management of acute postoperative pain is challenging, particularly in patients with preexisting narcotic dependency. Ketamine has been used at subanesthetic doses as a N-methyl d-aspartate (NMDA) receptor antagonist to block the processing of nociceptive input in chronic pain syndromes. This prospective randomized study was designed to assess the use of ketamine as an adjunct to acute pain management in narcotic tolerant patients after spinal fusions. Twenty-six patients for 1–2 level poster...

An observer-blinded randomized controlled pilot trial comparing localized immersion psoralen-ultraviolet A with localized narrowband ultraviolet B for the treatment of palmar hand eczema.

Science.gov (United States)

Brass, D; Fouweather, T; Stocken, D D; Macdonald, C; Wilkinson, J; Lloyd, J; Farr, P M; Reynolds, N J; Hampton, P J

2017-12-13

Hand eczema is a common inflammatory dermatosis that causes significant patient morbidity. Previous studies comparing psoralen-ultraviolet A (PUVA) with narrowband ultraviolet B (NB-UVB) have been small, nonrandomized and retrospective. To conduct an observer-blinded randomized controlled pilot study using validated scoring criteria to compare immersion PUVA with NB-UVB for the treatment of chronic hand eczema unresponsive to topical steroids. Sixty patients with hand eczema unresponsive to clobetasol propionate 0·05% were randomized to receive either immersion PUVA or NB-UVB twice weekly for 12 weeks with assessments at intervals of 4 weeks. The primary outcome measure was the proportion of patients achieving 'clear' or 'almost clear' Physician's Global Assessment (PGA) response at 12 weeks. Secondary outcome measures included assessment of the modified Total Lesion and Symptom Score (mTLSS) and the Dermatology Life Quality index (DLQI). In both treatment arms, 23 patients completed the 12-week assessment for the primary outcome measure. In the PUVA group, five patients achieved 'clear' and eight 'almost clear' [intention-to-treat (ITT) response rate 43%]. In the NB-UVB group, two achieved 'clear' and five 'almost clear' (ITT response rate 23%). For the secondary outcomes, median mTLSS scores were similar between groups at baseline (PUVA 9·5, NB-UVB 9) and at 12 weeks (PUVA 3, NB-UVB 4). Changes in DLQI were similar, with improvements in both groups. In this randomized pilot trial recruitment was challenging. After randomization, there were acceptable levels of compliance and safety in each treatment schedule, but lower levels of retention. Using validated scoring systems - PGA, mTLSS and DLQI - as measures of treatment response, the trial demonstrated that both PUVA and NB-UVB reduced the severity of chronic palmar hand eczema. © 2017 British Association of Dermatologists.

A Prospective Trial of Ayurveda for Coronary Heart Disease: A Pilot Study.

Science.gov (United States)

DuBroff, Robert; Lad, Vasant; Murray-Krezan, Cristina

2015-01-01

Coronary heart disease is the leading cause of death worldwide, and its incidence is rapidly accelerating in developing nations. Patients often search for therapies that are alternatives to traditional treatments, such as heart medicines, coronary bypass surgery, or coronary stenting. Ayurveda is an ancient, East Indian, holistic approach to health care, and its use has never been formally evaluated for patients with coronary heart disease. The study intended to examine the feasibility and effectiveness of comprehensive ayurvedic therapy-incorporating diet, meditation, breathing exercises, yoga, and herbs-for patients with established coronary heart disease. The study was a prospective, single-group, pilot study. The study took place at the University of New Mexico Cardiology Clinic and at the Ayurvedic Institute in Albuquerque, NM, USA. The participants were adults with a history of a prior heart attack, coronary bypass surgery, or a coronary intervention (ie, a coronary angioplasty and/or stent). All enrolled patients were evaluated by a single ayurvedic physician with >40 y of experience, and each received therapy consisting of a calorically unrestricted ayurvedic diet; instruction in yoga, meditation, and breathing; and use of ayurvedic herbs. The primary endpoint was arterial pulse wave velocity, a marker of arterial function and vascular health. Secondary endpoints included the following measurements: (1) body mass index (BMI); (2) blood pressure (BP) and amount of reduction in BP medications; and (3) levels of total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides. All parameters were measured at baseline and after 90 d of therapy. Twenty-two patients were enrolled in the study, and 19 patients completed it. The research team observed significant improvements in arterial pulse wave velocity (P = .015), and favorable reductions in BMI (P ayurveda on arterial function and multiple risk

Custom vs conventional PRK: a prospective, randomized, contralateral eye comparison of postoperative visual function.

Science.gov (United States)

Mifflin, Mark D; Hatch, Bryndon B; Sikder, Shameema; Bell, James; Kurz, Christopher J; Moshirfar, Majid

2012-02-01

To determine whether VISX S4 (VISX Inc) custom photorefractive keratectomy (PRK) results in better visual outcomes than VISX S4 conventional PRK. Photorefractive keratectomy was performed on 80 eyes from 40 patients in this randomized, prospective, contralateral eye study. Dominant eyes were randomized to one group with the fellow eye receiving the alternate treatment. Primary outcome measures included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), contrast sensitivity, and root-mean-square (RMS) higher order aberrations. Mean UDVA was -0.023±0.099 (20/19) in the custom group and -0.044±0.080 (20/18) in the conventional group 6 months after surgery (P=.293). Mean CDVA was -0.073±0.067 (20/17) in the custom group and -0.079±0.071 (20/17) in the conventional group 6 months after surgery (P=.659). Total higher order aberration RMS and spherical aberration increased in both groups compared to preoperative values (PPRK were shown to be safe and effective with excellent visual acuity and contrast sensitivity performance at 6 and 12 months. Conventional PRK induced more coma than custom PRK; however, this did not seem to correlate with clinical outcomes. Copyright 2012, SLACK Incorporated.

Association between Adult Height and Risk of Colorectal, Lung, and Prostate Cancer: Results from Meta-analyses of Prospective Studies and Mendelian Randomization Analyses

Science.gov (United States)

Khankari, Nikhil K.; Shu, Xiao-Ou; Wen, Wanqing; Kraft, Peter; Lindström, Sara; Peters, Ulrike; Schildkraut, Joellen; Schumacher, Fredrick; Bofetta, Paolo; Risch, Angela; Bickeböller, Heike; Amos, Christopher I.; Easton, Douglas; Gruber, Stephen B.; Haiman, Christopher A.; Hunter, David J.; Chanock, Stephen J.; Pierce, Brandon L.; Zheng, Wei

2016-01-01

Background Observational studies examining associations between adult height and risk of colorectal, prostate, and lung cancers have generated mixed results. We conducted meta-analyses using data from prospective cohort studies and further carried out Mendelian randomization analyses, using height-associated genetic variants identified in a genome-wide association study (GWAS), to evaluate the association of adult height with these cancers. Methods and Findings A systematic review of prospective studies was conducted using the PubMed, Embase, and Web of Science databases. Using meta-analyses, results obtained from 62 studies were summarized for the association of a 10-cm increase in height with cancer risk. Mendelian randomization analyses were conducted using summary statistics obtained for 423 genetic variants identified from a recent GWAS of adult height and from a cancer genetics consortium study of multiple cancers that included 47,800 cases and 81,353 controls. For a 10-cm increase in height, the summary relative risks derived from the meta-analyses of prospective studies were 1.12 (95% CI 1.10, 1.15), 1.07 (95% CI 1.05, 1.10), and 1.06 (95% CI 1.02, 1.11) for colorectal, prostate, and lung cancers, respectively. Mendelian randomization analyses showed increased risks of colorectal (odds ratio [OR] = 1.58, 95% CI 1.14, 2.18) and lung cancer (OR = 1.10, 95% CI 1.00, 1.22) associated with each 10-cm increase in genetically predicted height. No association was observed for prostate cancer (OR = 1.03, 95% CI 0.92, 1.15). Our meta-analysis was limited to published studies. The sample size for the Mendelian randomization analysis of colorectal cancer was relatively small, thus affecting the precision of the point estimate. Conclusions Our study provides evidence for a potential causal association of adult height with the risk of colorectal and lung cancers and suggests that certain genetic factors and biological pathways affecting adult height may also affect the

Melodic Intonation Therapy in chronic aphasia: evidence from a pilot randomized controlled trial

Directory of Open Access Journals (Sweden)

Ineke Van Der Meulen

2016-11-01

Full Text Available AbstractMelodic Intonation Therapy (MIT is a language production therapy for severely non-fluent aphasic patients using melodic intoning and rhythm to restore language. Although many studies have reported its beneficial effects on language production, randomized controlled trials (RCT examining the efficacy of MIT are rare. In an earlier publication, we presented the results of an RCT on MIT in subacute aphasia and found that MIT was effective on trained and untrained items. Further, we observed a clear trend in improved functional language use after MIT. Subacute aphasic patients receiving MIT improved considerably on language tasks measuring connected speech and daily life verbal communication. Here, we present the results of a pilot RCT on MIT in chronic aphasia and compare these to the results observed in subacute aphasia. We used a multicenter waiting-list randomized controlled trial design. Patients with chronic (>1 year post-stroke aphasia were randomly allocated to the experimental group (6 weeks MIT or to the control group (6 weeks no intervention followed by 6 weeks MIT. Assessments were done at baseline (T1, after 6 weeks (T2, and 6 weeks later (T3. Efficacy was evaluated at T2 using univariable linear regression analyses. Outcome measures were chosen to examine several levels of therapy success: improvement on trained items, generalization to untrained items, and generalization to verbal communication. Of 17 included patients, 10 were allocated to the experimental condition and 7 to the control condition. MIT significantly improved repetition of trained items (β=13.32, p=.02. This effect did not remain stable at follow-up assessment. In contrast to earlier studies, we found only a limited and temporary effect of MIT, without generalization to untrained material or to functional communication. The results further suggest that the effect of MIT in chronic aphasia is more restricted than its effect in earlier stages post stroke. This

Tampering by office-based methadone maintenance patients with methadone take home privileges: a pilot study

Directory of Open Access Journals (Sweden)

Frank Nathan

2007-10-01

Full Text Available Abstract Methadone Maintenance Treatment (MMT is among the most widely studied treatments for opiate dependence with proven benefits for patients and society. When misused, however, methadone can also be lethal. The issue of methadone diversion is a major concern for all MMT programs. A potential source for such diversion is from those MMT patients who receive daily take home methadone doses. Using a reverse phase high performance liquid chromatography method, seven of the nine patients who were randomly selected to have all of their remaining methadone take home doses (within a 24 hour period analyzed, returned lower than expected quantities of methadone. This finding suggests the possibility that such patients may have tampered with their daily take home doses. Larger prospective observational studies are clearly needed to test the supposition of this pilot study.

Syndesmotic fixation in supination-external rotation ankle fractures: a prospective randomized study.

Science.gov (United States)

Pakarinen, Harri J; Flinkkilä, Tapio E; Ohtonen, Pasi P; Hyvönen, Pekka H; Lakovaara, Martti T; Leppilahti, Juhana I; Ristiniemi, Jukka Y

2011-12-01

This study was designed to assess whether transfixion of an unstable syndesmosis is necessary in supination-external rotation (Lauge-Hansen SE/Weber B)-type ankle fractures. A prospective study of 140 patients with unilateral Lauge-Hansen supination-external rotation type 4 ankle fractures was done. After bony fixation, the 7.5-Nm standardized external rotation (ER) stress test for both ankles was performed under fluoroscopy. A positive stress examination was defined as a difference of more than 2 mm side-to-side in the tibiotalar or tibiofibular clear spaces on mortise radiographs. If the stress test was positive, the patient was randomized to either syndesmotic transfixion with 3.5-mm tricortical screws or no syndesmotic fixation. Clinical outcome was assessed using the Olerud-Molander scoring system, RAND 36-Item Health Survey, and Visual Analogue Scale (VAS) to measure pain and function after a minimum 1-year of followup. Twenty four (17%) of 140 patients had positive standardized 7.5-Nm ER stress tests after malleolar fixation. The stress view was positive three times on tibiotalar clear space, seven on tibiofibular clear space, and 14 times on both tibiotalar and tibiofibular clear spaces. There was no significant difference between the two randomization groups with regards to Olerud-Molander functional score, VAS scale measuring pain and function, or RAND 36-Item Health Survey pain or physical function at 1 year. Relevant syndesmotic injuries are rare in supination-external rotation ankle fractures, and syndesmotic transfixion with a screw did not influence the functional outcome or pain after the 1-year followup compared with no fixation.

An individually-tailored smoking cessation intervention for rural Veterans: a pilot randomized trial

Directory of Open Access Journals (Sweden)

Mark W. Vander Weg

2016-08-01

Full Text Available Abstract Background Tobacco use remains prevalent among Veterans of military service and those residing in rural areas. Smokers frequently experience tobacco-related issues including risky alcohol use, post-cessation weight gain, and depressive symptoms that may adversely impact their likelihood of quitting and maintaining abstinence. Telephone-based interventions that simultaneously address these issues may help to increase treatment access and improve outcomes. Methods This study was a two-group randomized controlled pilot trial. Participants were randomly assigned to an individually-tailored telephone tobacco intervention combining counseling for tobacco use and related issues including depressive symptoms, risky alcohol use, and weight concerns or to treatment provided through their state tobacco quitline. Selection of pharmacotherapy was based on medical history and a shared decision interview in both groups. Participants included 63 rural Veteran smokers (mean age = 56.8 years; 87 % male; mean number of cigarettes/day = 24.7. The primary outcome was self-reported 7-day point prevalence abstinence at 12 weeks and 6 months. Results Twelve-week quit rates based on an intention-to-treat analysis did not differ significantly by group (Tailored = 39 %; Quitline Referral = 25 %; odds ratio [OR]; 95 % confidence interval [CI] = 1.90; 0.56, 5.57. Six-month quit rates for the Tailored and Quitline Referral conditions were 29 and 28 %, respectively (OR; 95 % CI = 1.05; 0.35, 3.12. Satisfaction with the Tailored tobacco intervention was high. Conclusions Telephone-based treatment that concomitantly addresses other health-related factors that may adversely affect quitting appears to be a promising strategy. Larger studies are needed to determine whether this approach improves cessation outcomes. Trial registration ClinicalTrials.gov identifier number NCT01592695 registered 11 April 2012.

Prospective, pilot evaluation of the performance of nanofractional radiofrequency for improvement of skin texture via skin resurfacing.

Science.gov (United States)

Bohnert, Krista; Dorizas, Andrew; Sadick, Neil

2018-02-01

The latest generation of radiofrequency, nanofractional radiofrequency, allows the heat energy to be delivered through the use of pins or needles as electrodes, facilitating increased efficacy and reduced pain, downtime, and side effects. The objective of this prospective pilot clinical study was to evaluate the efficacy of nanofractional radiofrequency in skin resurfacing. Seventeen subjects were enrolled in the study, and each received three nanofractional radiofrequency (160-pin tip) treatments in the facial area at 3-week intervals. Follow-up visits were scheduled at 1 and 2 months after the final treatment. Clinical photography, patient, and investigator assessments were conducted during the treatment visits and follow-up. All subjects completed the study. At the 1- and 2-month follow-up, there was a moderate to significant improvement (2.6 and 3.5, respectively, P = .01) according to the investigator global esthetic improvement scale rating. Most subjects reported that they were satisfied or very satisfied with the outcome and level of comfort. Nanofractional radiofrequency is a safe and effective strategy for improving texture, tone, and skin laxity with high patient satisfaction and tolerable safety profile. © 2017 Wiley Periodicals, Inc.

A Pilot Randomized Controlled Trial of the ACCESS Program: A Group Intervention to Improve Social, Adaptive Functioning, Stress Coping, and Self-Determination Outcomes in Young Adults with Autism Spectrum Disorder

Science.gov (United States)

Oswald, Tasha M.; Winder-Patel, Breanna; Ruder, Steven; Xing, Guibo; Stahmer, Aubyn; Solomon, Marjorie

2018-01-01

The purpose of this pilot randomized controlled trial was to investigate the acceptability and efficacy of the Acquiring Career, Coping, Executive control, Social Skills (ACCESS) Program, a group intervention tailored for young adults with autism spectrum disorder (ASD) to enhance critical skills and beliefs that promote adult functioning,…

EMDR for Syrian refugees with posttraumatic stress disorder symptoms: results of a pilot randomized controlled trial

Directory of Open Access Journals (Sweden)

Ceren Acarturk

2015-05-01

Full Text Available Background: The most common mental health problems among refugees are depression and posttraumatic stress disorder (PTSD. Eye movement desensitization and reprocessing (EMDR is an effective treatment for PTSD. However, no previous randomized controlled trial (RCT has been published on treating PTSD symptoms in a refugee camp population. Objective: Examining the effect of EMDR to reduce the PTSD and depression symptoms compared to a wait-list condition among Syrian refugees. Method: Twenty-nine adult participants with PTSD symptoms were randomly allocated to either EMDR sessions (n=15 or wait-list control (n=14. The main outcome measures were Impact of Event Scale-Revised (IES-R and Beck Depression Inventory (BDI-II at posttreatment and 4-week follow-up. Results: Analysis of covariance showed that the EMDR group had significantly lower trauma scores at posttreatment as compared with the wait-list group (d=1.78, 95% CI: 0.92–2.64. The EMDR group also had a lower depression score after treatment as compared with the wait-list group (d=1.14, 95% CI: 0.35–1.92. Conclusion: The pilot RCT indicated that EMDR may be effective in reducing PTSD and depression symptoms among Syrian refugees located in a camp. Larger RCTs to verify the (cost- effectiveness of EMDR in similar populations are needed.

1% hydrocortisone ointment is an effective treatment of pruritus ani: a pilot randomized controlled crossover trial.

Science.gov (United States)

Al-Ghnaniem, R; Short, K; Pullen, A; Fuller, L C; Rennie, J A; Leather, A J M

2007-12-01

Pruritus ani (PA) is a common condition which is difficult to treat in the absence of obvious predisposing factors. There is paucity of evidence-based guidelines on the treatment of this condition. We examined whether 1% hydrocortisone ointment is an effective treatment for PA. A pilot randomized, double-blind, placebo-controlled, crossover trial was carried out. Eleven patients consented to take part in the trial and ten completed the study. After a 2-week run-in period, patients with primary PA were randomly allocated to receive 1% hydrocortisone ointment or placebo for 2 weeks followed by the opposite treatment for a further 2-week period. There was a washout period of 2 weeks between treatments. The primary outcome measure was reduction in itch using a visual analogue score (VAS). The secondary outcome measures were improvement in quality of life measured using a validated questionnaire (Dermatology Life Quality Index, DLQI) and improvement in clinical appearance of the perianal skin using the Eczema Area and Severity Index (EASI) score. Treatment with 1% hydrocortisone ointment resulted in a 68% reduction in VAS compared with placebo (P=0.019), a 75% reduction in DLQI score (P=0.067), and 81% reduction in EASI score (P=0.01). A short course of mild steroid ointment is an effective treatment for PA.

Laparoscopic Dor versus Toupet fundoplication following Heller myotomy for achalasia: results of a multicenter, prospective, randomized-controlled trial.

Science.gov (United States)

Rawlings, Arthur; Soper, Nathaniel J; Oelschlager, Brant; Swanstrom, Lee; Matthews, Brent D; Pellegrini, Carlos; Pierce, Richard A; Pryor, Aurora; Martin, Valeria; Frisella, Margaret M; Cassera, Maria; Brunt, L Michael

2012-01-01

The type of fundoplication that should be performed in conjunction with Heller myotomy for esophageal achalasia is controversial. We prospectively compared anterior fundoplication (Dor) with partial posterior fundoplication (Toupet) in patients undergoing laparoscopic Heller myotomy. A multicenter, prospective, randomized-controlled trial was initiated to compare Dor versus Toupet fundoplication after laparoscopic Heller myotomy. Outcome measures were symptomatic GERD scores (0-4, five-point Likert scale questionnaire) and 24-h pH testing at 6-12 months after surgery. Data are mean ± SD. Statistical analysis was by Mann-Whitney U test, Wilcoxon signed rank test, and Freidman's test. Sixty of 85 originally enrolled and randomized patients who underwent 36 Dor and 24 Toupet fundoplications had follow-up data per protocol for analysis. Dor and Toupet groups were similar in age (46.8 vs. 51.7 years) and gender (52.8 vs. 62.5% male). pH studies at 6-12 months in 43 patients (72%: Dor n = 24 and Toupet n = 19) showed total DeMeester scores and % time pH Heller myotomy provides significant improvement in dysphagia and regurgitation symptoms in achalasia patients regardless of the type of partial fundoplication. Although a higher percentage of patients in the Dor group had abnormal 24-h pH test results compared to those of patients who underwent Toupet, the differences were not statistically significant.

Arthroscopic cartilage debridement by excimer laser in chondromalacia of the knee joint. A prospective randomized clinical study.

Science.gov (United States)

Raunest, J; Löhnert, J

1990-01-01

A new operative technique in arthroscopic treatment of chondromalacia using ultraviolet laser systems is introduced. The postoperative results are evaluated in a prospective and randomized clinical trial. One hundred and forty patients stage II or III chondromalacia according to Outerbridge were randomly assigned to arthroscopic operation using either laser or mechanical instruments. After a 6-month follow-up period the clinical results were compared, guided by a specially designed modification of the Lysholm scoring scale. In the short-term follow-up laser surgery gave superior results in regard to reducing pain (P less than 0.05) and leading to a lower incidence of reactive synovitis (P less than 0.01). No difference was found in respect of disability and functional impairment. Our results lead to the conclusion that arthroscopic laser application seems to be a successful procedure in the treatment of degenerative cartilage disorders, providing precise ablation of tissue without significant thermal damage to the remaining cartilage.

Trial of early noninvasive ventilation for ALS: A pilot placebo-controlled study.

Science.gov (United States)

Jacobs, Teresa L; Brown, Devin L; Baek, Jonggyu; Migda, Erin M; Funckes, Timothy; Gruis, Kirsten L

2016-11-01

To evaluate the use and tolerability of noninvasive positive pressure ventilation (NIV) in patients with amyotrophic lateral sclerosis (ALS) early in their disease by comparing active NIV and sham NIV in patients not yet eligible for NIV use as recommended by practice guidelines. This was a single-center, prospective, double-blind, randomized, placebo (sham)-controlled pilot trial. Patients with ALS were randomized to receive either sham NIV or active NIV and underwent active surveillance approximately every 3 months until they reached a forced vital capacity (FVC) NIV for clinical symptom management. In total, 54 participants were randomized. The mean NIV use was 2.0 hours (95% confidence interval [CI] 1.1-3.0) per day in the sham NIV treatment group and 3.3 hours (CI 2.0-4.6) per day in the active NIV group, which did not differ by treatment group (p = 0.347). The majority of sham NIV participants (88%) and active NIV participants (73%) reported only mild or no problem with NIV use. Difference of change in FVC through the treatment period by group (0.44 per month) favored active NIV (p = 0.049). Survival and changes in maximal inspiratory or expiratory pressure did not differ between treatment groups. The efficacy of early NIV in ALS should be tested in randomized, placebo-controlled trials. The trial is registered on clinicaltrials.gov (NCT00580593). This study provides Class II evidence that for patients with ALS, adherence with NIV and sham NIV are similar. © 2016 American Academy of Neurology.

Transdermal rivastigmine for HIV-associated cognitive impairment: A randomized pilot study.

Directory of Open Access Journals (Sweden)

Jose A Muñoz-Moreno

Full Text Available To assess the efficacy and safety of transdermal rivastigmine for the treatment of HIV-associated cognitive impairment.We recruited HIV-infected patients with cognitive impairment on stable antiretroviral therapy in a randomized controlled pilot trial with a 48-week follow-up. An additional assessment was held at 12 weeks. Participants received transdermal rivastigmine (9.5 mg daily, lithium (400 mg twice daily, titrated progressively, or remained in a control group (no new medication. The primary efficacy endpoint was change in a global cognitive score (NPZ-7. Secondary endpoints included change in specific cognitive measures, domains, and functional parameters. Safety covered the frequency of adverse events and changes in laboratory results.Seventy-six subjects were screened, and 29 were finally enrolled. Better cognitive outcomes were observed in all groups, although there were no significant differences between the arms (mean NPZ-7 change [SD]: rivastigmine, 0.35 (0.14; lithium, 0.25 (0.40; control, 0.20 (0.44 (p = 0.78. The rivastigmine group showed the highest positive trend (mean NPZ-7 [SD], baseline vs week 48: rivastigmine, -0.47 (0.22 vs -0.11 (0.29, p = 0.06; lithium, -0.50 (0.40 vs -0.26 (0.21, p = 0.22; control, -0.52 (0.34 vs -0.32 (0.52, p = 0.44. The cognitive domains with the highest positive trends were information processing speed at week 12 and executive function at week 48 (rivastigmine vs control: information processing speed, 0.35 (0.64 vs -0.13 (0.25, p = 0.17, d = 0.96; and executive functioning, 0.73 (0.33 vs 0.03 (0.74, p = 0.09, d = 1.18. No relevant changes were observed regarding functional outcomes. A total of 12 (41% individuals dropped out of the study: 2 (20% were due to medication-related effects in the rivastigmine group and 4 (36% in the lithium group. No severe adverse events were reported.The results from this small randomized trial indicate that transdermal rivastigmine did not provide significant

Evaluation of a “Just-in-Time” Nurse Consultation on Bone Health: A Pilot Randomized Controlled Trial

Science.gov (United States)

Roblin, Douglas W; Zelman, David; Plummer, Sally; Robinson, Brandi E; Lou, Yiyue; Edmonds, Stephanie W; Wolinsky, Fredric D; Saag, Kenneth G; Cram, Peter

2017-01-01

Context Evidence is inconclusive whether a nurse consultation can improve osteoporosis-related patient outcomes. Objective To evaluate whether a nurse consultation immediately after dual-energy x-ray absorptiometry (DXA) produced better osteoporosis-related outcomes than a simple intervention to activate adults in good bone health practices or usual care. Design Pilot randomized controlled trial, conducted within the larger Patient Activation After DXA Result Notification (PAADRN) trial (NCT01507662). After DXA, consenting adults age 50 years or older were randomly assigned to 3 groups: nurse consultation, PAADRN intervention (mailed letter with individualized fracture risk and an educational brochure), or usual care (control). Nurse consultation included reviewing DXA results, counseling on bone health, and ordering needed follow-up tests or physician referrals. Main Outcome Measures Change from baseline to 52 weeks in participant-reported osteoporosis-related pharmacotherapy, lifestyle, activation and self-efficacy, and osteoporosis care satisfaction. Results Nurse consultation participants (n = 104) reported 52-week improvements in strengthening and weight-bearing exercise (p = 0.09), calcium intake (p Just-in-time” nurse consultation yielded a few improvements over 52 weeks in osteoporosis-related outcomes; however, most changes were not different from those obtained through the lower-cost PAADRN intervention or usual care. PMID:28746019

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

Science.gov (United States)

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

2012-01-01

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

The ExStroke Pilot Trial: rationale, design, and baseline data of a randomized multicenter trial comparing physical training versus usual care after an ischemic stroke

DEFF Research Database (Denmark)

Krarup, L.H.; Gluud, C.; Truelsen, T.

2008-01-01

of increasing stroke patients' level of physical activity and secondarily to associate the level of physical activity to the risk of recurrent stroke, myocardial infarction, and all-cause mortality in the two groups. We describe the rationale, design, and baseline data of the ExStroke Pilot Trial. METHODS......INTRODUCTION: A high level of physical activity is associated with a decreased risk of first stroke and physical activity modifies recognized stroke risk factors and is recommended for stroke survivors. Available research shows that stroke patients can increase their level of physical performance...... over a short period. When the intervention period is over, physical performance often declines towards baseline level. Currently, there is no evidence on the association between physical activity and the risk of recurrent stroke. The ExStroke Pilot Trial is a randomized clinical trial with the aim...

Effects of active/passive interventions on pain, anxiety, and quality of life in women with fibromyalgia: Randomized controlled pilot trial.

Science.gov (United States)

Ekici, Gamze; Unal, Edibe; Akbayrak, Turkan; Vardar-Yagli, Naciye; Yakut, Yavuz; Karabulut, Erdem

2017-01-01

The authors of this study compared the effects of pilates exercises and connective tissue massage (CTM) on pain intensity; pain-pressure threshold; and tolerance, anxiety, progress, and health-related quality of life in females with fibromyalgia. It was a pilot, assessor masked, randomized controlled trial conducted between January and August of 2013. Twenty-one women with fibromyalgia were randomly assigned to the pilates exercise program (six of whom did not complete the program), and 22 were randomly assigned to CTM (one of whom did not complete this program). Each group received the assigned intervention three times per week during a 4-week period. The Visual Analogue Scale, algometry, State-Trait Anxiety Inventory, Fibromyalgia Impact Questionnaire, and Nottingham Health Profile were used at baseline and at the end of treatments. Significant improvements were found in both groups for all parameters. However, the scores for pain-pressure threshold were significantly elevated and the symptoms of anxiety were significantly diminished in the exercise group compared to the massage group. Thus, exercise and massage might be used to provide improvements in women with fibromyalgia. The exercise group showed more advantages than the massage group and thus might be preferred for patients with fibromyalgia. However, an adequately powered trial is required to determine this with certainty.

Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) for veterans with traumatic brain injury: pilot randomized controlled trial.

Science.gov (United States)

Twamley, Elizabeth W; Jak, Amy J; Delis, Dean C; Bondi, Mark W; Lohr, James B

2014-01-01

Traumatic brain injury (TBI) can result in cognitive impairments and persistent postconcussive symptoms that limit functional recovery, including return to work. We evaluated a 12 wk compensatory cognitive training intervention (Cognitive Symptom Management and Rehabilitation Therapy [CogSMART]) in the context of supported employment for Veterans with mild to moderate TBI. Participants were randomly assigned to receive 12 wk of supported employment plus CogSMART or enhanced supported employment that controlled for therapist attention (control). CogSMART sessions were delivered by the employment specialist and included psychoeducation regarding TBI; strategies to improve sleep, fatigue, headaches, and tension; and compensatory cognitive strategies in the domains of prospective memory, attention, learning and memory, and executive functioning. Compared with controls, those assigned to supported employment plus CogSMART demonstrated significant reductions in postconcussive symptoms (Cohen d = 0.97) and improvements in prospective memory functioning (Cohen d = 0.72). Effect sizes favoring CogSMART for posttraumatic stress disorder symptom severity, depressive symptom severity, and attainment of competitive work within 14 wk were in the small to medium range (Cohen d = 0.35-0.49). Those who received CogSMART rated the intervention highly. Results suggest that adding CogSMART to supported employment may improve postconcussive symptoms and prospective memory. These effects, as well as smaller effects on psychiatric symptoms and ability to return to work, warrant replication in a larger trial.

Effectiveness of aerobic gymnastic exercise on stress, fatigue, and sleep quality during postpartum: A pilot randomized controlled trial.

Science.gov (United States)

Yang, Chiu-Ling; Chen, Chung-Hey

2018-01-01

Gymnastics is a preferable safe exercise for postnatal women performing regularly. The aim of this pilot randomized controlled trial was to determine whether the aerobic gymnastic exercise improves stress, fatigue, sleep quality and depression in postpartum women. Single-blinded, randomized controlled trial held from December 2014 until September 2015. Postnatal clinic of a medical center in southern Taiwan. 140 eligible postnatal women were systematically assigned, with a random start to experimental (n=70) or a control (n=70) group. Engage in aerobic gymnastic exercise at least three times (15min per section) a week for three months using compact disc in the home. Perceived Stress Scale, Postpartum Fatigue Scale, Postpartum Sleep Quality Scale, and Edinburgh Postnatal Depression Scale. In a two-way ANOVA with repeated measures, the aerobic gymnastic exercise group showed significant decrease in fatigue after practicing exercise 4 weeks and the positive effects extended to the 12-week posttests. Paired t-tests revealed that aerobic gymnastic exercise participants had improved significantly in perceived stress and fatigue after 4 weeks gymnastic exercise; these positive effects extended to the 12-week posttests. In addition, the changes in physical symptoms-related sleep inefficiency after 12 weeks gymnastic exercise were significantly decreased in the experimental group compared with the control group. The findings can be used to encourage postnatal women to perform moderate-intensity gymnastic exercise in their daily life to reduce their stress, fatigue and improve sleep quality. Copyright © 2017 Elsevier Ltd. All rights reserved.

DADOS-Prospective: an open source application for Web-based prospective data collection

Directory of Open Access Journals (Sweden)

Nguyen Lam

2006-11-01

Full Text Available Abstract Background Randomized, prospective trials involving multi-institutional collaboration have become a central part of clinical and translational research. However, data management and coordination of multi-center studies is a complex process that involves developing systems for data collection and quality control, tracking data queries and resolutions, as well as developing communication procedures. We describe DADOS-Prospective, an open-source Web-based application for collecting and managing prospective data on human subjects for clinical and translational trials. DADOS-Prospective not only permits users to create new clinical research forms (CRF and supports electronic signatures, but also offers the advantage of containing, in a single environment, raw research data in downloadable spreadsheet format, source documentation and regulatory files stored in PDF format, and audit trails. Results Feedback from formal and field usability tests was used to guide the design and development of DADOS-Prospective. To date, DADOS-Prospective has been implemented in five prospective clinical studies at our institution. Four of these studies are still in the CRF creation phase and one study has been entirely launched. Conclusion DADOS-Prospective has significant advantages over existing Web-based data collecting programs. At our institution, it has been demonstrated to be an efficient tool for prospective clinical studies.

Reduction of shunt obstructions by using a peel-away sheath technique? A multicenter prospective randomized trial.

Science.gov (United States)

Kehler, Uwe; Langer, Niels; Gliemroth, Jan; Meier, Ullrich; Lemcke, Johannes; Sprung, Christian; Schlosser, Hans-Georg; Kiefer, Michael; Eymann, Regina; Heese, Oliver

2012-05-01

Shunt obstructions may partly be caused by brain debris, which intrude into the ventricular catheter during ventricle puncture. Avoiding contact between the catheter and brain tissue, by using a peel-away sheath, should reduce the number of shunt failures caused by obstruction. To test this hypothesis, we conducted a randomized, prospective multicenter study. 201 patients from 6 different neurosurgical centers in Germany receiving a ventriculo-peritoneal shunt were included in this study. Of these, 177 patients completed a 1-year follow-up period. Surgery was randomized in a 1 to 1 fashion, such that out of 177 procedures, 91 were performed using a peel-away sheath and 86 were performed without. The rate of surgical re-interventions and shunt obstructions within a 12-month period was recorded. Within 1 year post-surgery, 17 shunt obstructions (9.6%) leading to shunt revisions were recorded. However, no difference was found between surgeries performed using a peel-away sheath (9.9%) or not (9.3%). The overall shunt infection rate was 2.8% and the shunt revision rate for overdrainage was 3.9%. The theoretical advantages attributed to the use of a peel-away sheath to introduce a ventricular catheter could not be confirmed in this randomized study, suggesting that the proposed role of brain debris in shunt obstructions may be overestimated. Copyright © 2011 Elsevier B.V. All rights reserved.

A Comparison of Radiofrequency-Based Microtenotomy and Arthroscopic Release of the Extensor Carpi Radialis Brevis Tendon in Recalcitrant Lateral Epicondylitis: A Prospective Randomized Controlled Study.

Science.gov (United States)

Lee, Jae-Hoo; Park, In; Hyun, Hwan-Sub; Shin, Sang-Jin

2018-01-20

To compare the clinical effects of radiofrequency (RF)-based microtenotomy and arthroscopic release of the extensor carpi radialis brevis (ECRB) tendon in patients with recalcitrant lateral epicondylitis through a prospective randomized controlled study. A total of 46 patients were randomly assigned to receive arthroscopic release (group A, 24 patients) or RF-based microtenotomy (group B, 22 patients). The visual analog scale (VAS) score for pain, flexion-extension arc, operation time, Disabilities of the Arm, Shoulder, and Hand questionnaire (DASH), Mayo Elbow Performance Score (MEPS), and grip power of groups A and B were compared during the recovery phases for up to 2 postoperative years. Both groups showed statistically significant functional improvement compared with their preoperative grip strength and DASH, VAS, and MEPS scores at 2 years after surgery (P lateral epicondylitis provided clinical outcomes comparable with those from arthroscopic release of ECRB tendon during the recovery phase. RF-based microtenotomy is considered as one of the surgical procedures for treating recalcitrant lateral epicondylitis, with the advantages of reliable elbow functional restoration and significantly shorter operation time. Level I, prospective randomized trial. Copyright © 2017 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Is Home-Based, High-Intensity Interval Training Cycling Feasible and Safe for Patients With Knee Osteoarthritis?: Study Protocol for a Randomized Pilot Study.

Science.gov (United States)

Keogh, Justin W L; Grigg, Josephine; Vertullo, Christopher J

2017-03-01

Osteoarthritis (OA) is a degenerative joint disease affecting the knee joint of many middle-aged and older adults. As OA symptoms typically involve knee pain and stiffness, individuals with knee OA are often insufficiently physically active, have low levels of physical function, and are at increased risk of other comorbidities and reduced quality of life. While moderate-intensity continuous training (MICT) cycling is often recommended, little is known about the feasibility, safety, and benefits of high-intensity interval training (HIIT) cycling for this population, even though the feasibility, safety, and benefits of HIIT have been demonstrated in other chronic disease groups. The primary objective of this pilot study was to examine the feasibility and safety of home-based HIIT and MICT cycling in middle-aged and older adults with knee OA. A secondary objective was to gain some insight into the relative efficacy of HIIT and MICT for improving health status (pain, stiffness, and disability), muscle function, and body composition in this population. This study protocol is being published separately to allow a detailed description of the research methods, explain the rationale for choosing the methodological details, and to stimulate consideration of the best means to simulate a research protocol that is relevant to a real-life treatment environment. Randomized pilot study protocol. This trial sought to recruit 40 middle-aged and older adults with knee OA. Participants were randomly allocated to either continuous (MICT) or HIIT home-based cycle training programs, with both programs requiring the performance of 4 cycling sessions (approximately 25 minutes per session) each week. Participants were measured at baseline and postintervention (8 weeks). Feasibility and safety were assessed by adherence rate, dropout rate, and number of adverse events. The relative efficacy of the cycling programs was investigated by 2 knee OA health status questionnaires (Western Ontario

Recruitment for 'A pilot study of randomized controlled trial to evaluate the efficacy of lung cancer screening by thoracic CT'

International Nuclear Information System (INIS)

Sagawa, Motoyasu; Tanaka, Makoto; Mizukami, Satoru

2011-01-01

The objective of this study was to evaluate the efficacy of lung cancer screening by thoracic computed tomography (CT), a randomized controlled trial was planned in Japan. The randomized trial was designed as follows: participants were randomly assigned into 2 groups, CT group and XP group; XP group would receive 10 times of lung cancer screening by chest x-ray annually for 10 years; smokers in CT group would receive 10 times of lung cancer screening by thoracic CT annually for 10 years; non-smokers in CT group would receive 3 times of lung cancer screening by thoracic CT and 7 times of chest x-ray during 10 years. A pilot study was performed to evaluate the feasibility of the trial. A letter for recruitment to participate in the above trial was mailed to the citizens in Hakui City, who were 50-64 years old and underwent regular lung cancer screening using chest x-ray this year. In the letter we explained that the efficacy of lung cancer screening by thoracic CT had not been proved yet; only half of the participants could undergo thoracic CT screening; thoracic CT screening might cause unfavorable consequences like radiation exposure, false positives or overdiagnosis. Of 329 persons who received the letter of recruitment, 117 replied. After meeting with us for detailed explanation, 111 persons participated in the above randomized trial. The compliance of recruitment is high (approximately one third) and the above trial may be feasible. (author)

Effect of Vibration on Pain Response to Heel Lance: A Pilot Randomized Control Trial.

Science.gov (United States)

McGinnis, Kate; Murray, Eileen; Cherven, Brooke; McCracken, Courtney; Travers, Curtis

2016-12-01

Applied mechanical vibration in pediatric and adult populations has been shown to be an effective analgesic for acute and chronic pain, including needle pain. Studies among the neonatal population are lacking. According to the Gate Control Theory, it is expected that applied mechanical vibration will have a summative effect with standard nonpharmacologic pain control strategies, reducing behavioral and physiologic pain responses to heel lancing. To determine the safety and efficacy of mechanical vibration for relief of heel lance pain among neonates. In this parallel design randomized controlled trial, eligible enrolled term or term-corrected neonates (n = 56) in a level IV neonatal intensive care unit were randomized to receive either sucrose and swaddling or sucrose, swaddling, and vibration for heel lance analgesia. Vibration was applied using a handheld battery-powered vibrator (Norco MiniVibrator, Hz = 92) to the lateral aspect of the lower leg along the sural dermatome throughout the heel lance procedure. Neonatal Pain, Agitation, and Sedation Scale (N-PASS) scores, heart rate, and oxygen saturations were collected at defined intervals surrounding heel lancing. Infants in the vibration group (n = 30) had significantly lower N-PASS scores and more stable heart rates during heel stick (P = .006, P = .037) and 2 minutes after heel lance (P = .002, P = .016) than those in the nonvibration group. There were no adverse behavioral or physiologic responses to applied vibration in the sample. Applied mechanical vibration is a safe and effective method for managing heel lance pain. This pilot study suggests that mechanical vibration warrants further exploration as a nonpharmacologic pain management tool among the neonatal population.

Group Singing as a Therapy during Diabetes Training--A Randomized Controlled Pilot Study.

Science.gov (United States)

Groener, J B; Neus, I; Kopf, S; Hartmann, M; Schanz, J; Kliemank, E; Wetekam, B; Kihm, L; Fleming, T; Herzog, W; Nawroth, P P

2015-11-01

Comprehensive diabetes treatment has been shown to reduce quality of life in diabetic patients. However, there is evidence to suggest that group singing can have positive effects on quality of life in various clinical settings. In this randomized controlled pilot study, the effect of singing as a therapy to reduce stress and improve quality of life was investigated in insulin-dependent diabetic patients, undergoing a lifestyle intervention program. Patients from the singing group felt less discontented following treatment. This effect, however, was lost after 3 months. No effect on serum cortisol and plasma adrenocorticotropic hormone (ACTH) levels could be seen when comparing the singing group with the control group, although reduced levels of ACTH and cortisol 3 days after treatment could be found and were still present after 3 months within the group of patients who undertook singing as a therapy. Singing led to an increase in bodyweight, which interestingly had no effect on glucose control or methylglyoxal levels. Therefore, singing during a lifestyle intervention program for insulin-dependent diabetic patients had a short lasting and weak effect on patients' mood without affecting glucose control, but no significant effect on stress related hormones. © Georg Thieme Verlag KG Stuttgart · New York.

Alcohol interventions for mandated students: behavioral outcomes from a randomized controlled pilot study.

Science.gov (United States)

Logan, Diane E; Kilmer, Jason R; King, Kevin M; Larimer, Mary E

2015-01-01

This study investigated the effectiveness of three single-session interventions with high-risk mandated students while considering the influence of motivational interviewing (MI) microskills. This randomized, controlled pilot trial evaluated single-session interventions: Alcohol Skills Training Program (ASTP), Brief Alcohol Screening and Intervention for College Students (BASICS) feedback sessions, and treatment-as-usual Alcohol Diversion Program (ADP) educational groups. Participants were 61 full-time undergraduates at a southern U.S. campus sanctioned to a clinical program following violation of an on-campus alcohol policy (Mage = 19.16 years; 42.6% female). RESULTS revealed a significant effect of time for reductions in estimated blood alcohol concentration (eBAC) and number of weekly drinks but not in alcohol-related consequences. Although ASTP and BASICS participants reported significant decreases in eBAC over time, ADP participant levels did not change (with no intervention effects on quantity or consequences). MI microskills were not related to outcomes. RESULTS from this study suggest equivalent behavioral impacts for the MI-based interventions, although individual differences in outcome trajectories suggest that research is needed to further customize mandated interventions. Given the overall decrease in eBAC following the sanction, the lack of reduction in the ADP condition warrants caution when using education-only interventions.

Competence feedback improves CBT competence in trainee therapists: A randomized controlled pilot study.

Science.gov (United States)

Weck, Florian; Kaufmann, Yvonne M; Höfling, Volkmar

2017-07-01

The development and improvement of therapeutic competencies are central aims in psychotherapy training; however, little is known about which training interventions are suitable for the improvement of competencies. In the current pilot study, the efficacy of feedback regarding therapeutic competencies was investigated in cognitive behavioural therapy (CBT). Totally 19 trainee therapists and 19 patients were allocated randomly to a competence feedback group (CFG) or control group (CG). Two experienced clinicians and feedback providers who were blind to the treatment conditions independently evaluated therapeutic competencies on the Cognitive Therapy Scale at five treatment times (i.e., at Sessions 1, 5, 9, 13, and 17). Whereas CFG and CG included regular supervision, only therapists in the CFG additionally received written qualitative and quantitative feedback regarding their demonstrated competencies in conducting CBT during treatment. We found a significant Time × Group interaction effect (η² = .09), which indicates a larger competence increase in the CFG in comparison to the CG. Competence feedback was demonstrated to be suitable for the improvement of therapeutic competencies in CBT. These findings may have important implications for psychotherapy training, clinical practice, and psychotherapy research. However, further research is necessary to ensure the replicability and generalizability of the findings.

A prospective randomized study comparing unipolar versus bipolar hysteroscopic myomectomy in infertile women

Directory of Open Access Journals (Sweden)

Kallol K Roy

2017-01-01

Full Text Available Study Objective: To compare the operative and reproductive outcome of hysteroscopic myomectomy using unipolar resectoscope versus bipolar resectoscope in patients with infertility and menorrhagia. Design: Randomized, prospective, parallel, comparative, single-blinded study. Design Classification: Canadian Task Force classification I. Setting: Tertiary care institute. Patients: Sixty women with submucous myoma and infertility. Interventions: Hysteroscopic myomectomy performed with unipolar resectoscope or bipolar resectoscope. Measurements: Primary outcome measures were the pregnancy-related indicators. Secondary outcome measures were the operative parameters, harmful outcomes related to the procedure, and comparison of improvement levels in the menstrual pattern after surgery between the two groups. Main Results: A total of 60 patients were randomized into two groups of equal size. Baseline characteristics were not significantly different between the two groups. Reduction in sodium level from pre- to postsurgery was significantly (P = 0.001 higher in the unipolar group. Nine patients (30% in the unipolar group had hyponatremia in the postoperative period compared to none in the bipolar group (P = 0.002. However, there was no significant difference in the other operative parameters between the two groups. In both the groups, a significant improvement in the menstrual symptoms was observed after myomectomy. Pregnancy-related outcomes were similar in both the groups. Conclusion: The use of bipolar resectoscope for hysteroscopic myomectomy is associated with lesser risk of hyponatremia compared to unipolar resectoscope. Bipolar resectoscopic myomectomy is found to be an effective and safer alternative to unipolar resectoscopy with similar reproductive outcome.

Wood torrefaction. Pilot tests and utilisation prospects

Energy Technology Data Exchange (ETDEWEB)

Wilen, C.; Jukola, P.; Jarvinen, T.; Sipila, K. [VTT Technical Reseach Centre of Finland, Espoo (Finland); Verhoeff, F.; Kiel, J. [Energy research Centre of the Netherlands, LE Petten (Netherlands)

2013-09-15

The research project 'Torrefaction of woody biomasses as energy carriers for the European markets' was carried out within the Tekes BioRefine programme in 2010-2012 and was coordinated by VTT. The main objective of the project was to create a discussion platform and collate basic information for the Finnish industrial stakeholders involved in developing torrefaction technology or planning to include torrefied biomass in their fuel supply for energy production. Given the availability of torrefaction pilot facilities in Europe, it was decided at an early phase of the national torrefaction research project not to build and operate separate pilot equipment, and thus save time and money. Experimental research was conducted in cooperation with ECN, The Netherlands. Finnish wood chips and crushed forest residue were tested at different torrefaction temperatures in the PATRIG torrefaction test rig with great success, and large quantities of torrefied wood chips and pellets were produced. CFD simulation work was carried out at VTT to investigate the feasibility of torrefied fuels to replace part of the coal. From the combustion point of view it seems feasible to replace coal by torrefied wood biomass with shares up to 50% by weight. Basic, small-scale experiments were carried out to compare torrefied wood pellets with conventional wood and straw pellets with regard to their handling and storage properties. The experiments showed that the torrefied pellets are clearly more hydrophobic than wood and straw pellets and do not disintegrate completely on exposure to water. A study on dust explosion and self-ignition characteristics indicated that the torrefied dust does not differ significantly from the normal biomass dust, but is clearly more reactive than coal dust. Commercial development of torrefaction is currently in its early phase. The current general view is that most of the demonstration plants have technical problems, which have delayed their commercial

A pilot randomized controlled trial of on-line interventions to improve sleep quality in adults after mild or moderate traumatic brain injury.

Science.gov (United States)

Theadom, Alice; Barker-Collo, Suzanne; Jones, Kelly; Dudley, Margaret; Vincent, Norah; Feigin, Valery

2018-05-01

To explore feasibility and potential efficacy of on-line interventions for sleep quality following a traumatic brain injury (TBI). A two parallel-group, randomized controlled pilot study. Community-based. In all, 24 participants (mean age: 35.9 ± 11.8 years) who reported experiencing sleep difficulties between 3 and 36 months after a mild or moderate TBI. Participants were randomized to receive either a cognitive behaviour therapy or an education intervention on-line. Both interventions were self-completed for 20-30 minutes per week over a six-week period. The Pittsburgh Sleep Quality Index assessed self-reported sleep quality with actigraphy used as an objective measure of sleep quality. The CNS Vital Signs on-line neuropsychological test assessed cognitive functioning and the Rivermead Post-concussion Symptoms and Quality of Life after Brain Injury questionnaires were completed pre and post intervention. Both programmes demonstrated feasibility for use post TBI, with 83.3% of participants completing the interventions. The cognitive behaviour therapy group experienced significant reductions ( F = 5.47, p = 0.04) in sleep disturbance (mean individual change = -4.00) in comparison to controls post intervention (mean individual change = -1.50) with a moderate effect size of 1.17. There were no significant group differences on objective sleep quality, cognitive functioning, post-concussion symptoms or quality of life. On-line programmes designed to improve sleep are feasible for use for adults following mild-to-moderate TBI. Based on the effect size identified in this pilot study, 128 people (64 per group) would be needed to determine clinical effectiveness.

Values-based action in fibromyalgia: results from a randomized pilot of acceptance and commitment therapy

Directory of Open Access Journals (Sweden)

Jennifer L. Steiner

2013-09-01

Full Text Available Fibromyalgia Syndrome (FMS is a chronic pain condition characterized by pain, fatigue, and nonrestorative sleep. The disruptive symptoms of FMS are associated with reductions in quality of life related to family, intimate relationships, and work. The present study was part of a randomized pilot study of an 8-week Acceptance and Commitment Therapy (ACT intervention compared to education in a sample of 28 women with FMS. The Chronic Pain Values Inventory was administered at baseline, postintervention, and 12 week follow-up. Both groups showed significant improvements in family success, which were maintained at follow-up. Groups showed a differential pattern of success in work. The ACT group demonstrated significant, maintained improvements in success in intimate relationships, while the education group reported no changes over time. Findings suggest that both interventions may lead to improvements in valued living; however different interventions may be best suited for certain valued domains. The results of this study indicate that FMS patients are able to improve their success in family and intimate relationships and losses in these areas are not necessarily permanent.

Pilot Randomized Trial of Active Music Engagement Intervention Parent Delivery for Young Children With Cancer.

Science.gov (United States)

Robb, Sheri L; Haase, Joan E; Perkins, Susan M; Haut, Paul R; Henley, Amanda K; Knafl, Kathleen A; Tong, Yan

2017-03-01

To examine the feasibility/acceptability of a parent-delivered Active Music Engagement (AME + P) intervention for young children with cancer and their parents. Secondary aim to explore changes in AME + P child emotional distress (facial affect) and parent emotional distress (mood; traumatic stress symptoms) relative to controls. A pilot two-group randomized trial was conducted with parents/children (ages 3-8 years) receiving AME + P ( n  =  9) or attention control ( n  =  7). Feasibility of parent delivery was assessed using a delivery checklist and child engagement; acceptability through parent interviews; preliminary outcomes at baseline, postintervention, 30 days postintervention. Parent delivery was feasible, as they successfully delivered AME activities, but interviews indicated parent delivery was not acceptable to parents. Emotional distress was lower for AME + P children, but parents derived no benefit. Despite child benefit, findings do not support parent delivery of AME + P. © 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

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

Directory of Open Access Journals (Sweden)

Ravichandran Hariharasudhan

2016-01-01

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

Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials

Energy Technology Data Exchange (ETDEWEB)

Logan, Jennifer K.; Tang, Chad; Liao, Zhongxing [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Lee, J. Jack [Department of Biostatistics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Heymach, John V. [Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Swisher, Stephen G. [Department of Surgical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Welsh, James W. [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Zhang, Jianjun [Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Lin, Steven H. [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Gomez, Daniel R., E-mail: dgomez@mdanderson.org [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States)

2017-03-15

Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.

Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials

International Nuclear Information System (INIS)

Logan, Jennifer K.; Tang, Chad; Liao, Zhongxing; Lee, J. Jack; Heymach, John V.; Swisher, Stephen G.; Welsh, James W.; Zhang, Jianjun; Lin, Steven H.; Gomez, Daniel R.

2017-01-01

Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.

MicroSaw and Piezosurgery in Harvesting Mandibular Bone Blocks from the Retromolar Region: A Randomized Split-Mouth Prospective Clinical Trial.

Science.gov (United States)

Hanser, Thomas; Doliveux, Romain

The aim of this randomized prospective split-mouth clinical trial was to evaluate the outcome of bone block harvesting from the retromolar region using the MicroSaw and Piezosurgery. Fifty-three patients for extensive bilateral bone grafting procedures with or without concomitant implant placement in the maxilla and/or mandible were scheduled. In each patient, bone blocks were harvested in the retromolar area within the external oblique ridge of the mandible. Using a randomized protocol, bone blocks were harvested with the MicroSaw and Piezosurgery either from the right or the left side. Clinical outcome parameters were the comparison of osteotomy time; volume of block graft; and clinical determination of intraoperative complications such as hemorrhage, nerve injury, pain, swelling, and healing of the donor site. The mean osteotomy time for harvesting including luxating a bone block was 5.63 (± 1.37) minutes using the MicroSaw and 16.47 (± 2.74) minutes using Piezosurgery (P .05). Swelling did not appear significantly different either (P > .05), and none of the donor sites showed primary healing complications. The data described in this randomized prospective split-mouth clinical trial indicate that the MicroSaw and Piezosurgery allowed efficient and safe bone block harvesting from the external oblique ridge. Clinically, concerning harvesting time and volume of the grafts, the MicroSaw performed significantly better, whereas pain, swelling, and healing did not appear to be considerably different. Given the improved visibility, precise cut geometries, and the margin of safety afforded by the MicroSaw and Piezosurgery, they are both instruments of choice when harvesting bone from the retromolar area.

Massage therapy and exercise therapy in patients with multiple sclerosis: a randomized controlled pilot study.

Science.gov (United States)

Negahban, Hossein; Rezaie, Solmaz; Goharpey, Shahin

2013-12-01

The primary aim was to investigate the comparative effects of massage therapy and exercise therapy on patients with multiple sclerosis. The secondary aim was to investigate whether combination of both massage and exercise has an additive effect. Randomized controlled pilot trial with repeated measurements and blinded assessments. Local Multiple Sclerosis Society. A total of 48 patients with multiple sclerosis were randomly assigned to four equal subgroups labelled as massage therapy, exercise therapy, combined massage-exercise therapy and control group. The treatment group received 15 sessions of supervised intervention for five weeks. The massage therapy group received a standard Swedish massage. The exercise therapy group was given a combined set of strength, stretch, endurance and balance exercises. Patients in the massage-exercise therapy received a combined set of massage and exercise treatments. Patients in the control group were asked to continue their standard medical care. Pain, fatigue, spasticity, balance, gait and quality of life were assessed before and after intervention. Massage therapy resulted in significantly larger improvement in pain reduction (mean change 2.75 points, P = 0.001), dynamic balance (mean change, 3.69 seconds, P = 0.009) and walking speed (mean change, 7.84 seconds, P = 0.007) than exercise therapy. Patients involved in the combined massage-exercise therapy showed significantly larger improvement in pain reduction than those in the exercise therapy (mean change, 1.67 points, P = 0.001). Massage therapy could be more effective than exercise therapy. Moreover, the combination of massage and exercise therapy may be a little more effective than exercise therapy alone.

Malignant astrocytoma: hyperfractionated and standard radiotherapy with chemotherapy in a randomized prospective clinical trial

International Nuclear Information System (INIS)

Payne, D.G.; Simpson, W.J.; Keen, C.; Platts, M.E.

1982-01-01

A prospective randomized trial of 157 patients with malignant astrocytomas (Grade III or IV) was carried out at a single institution. The minimization technique ensured balanced distribution of prognostic factors between the treatment groups. All received oral lomustine (CCNU, 80 mg/m 2 ) six weekly and hydroxyurea (HU, 3.5 gm/m 2 over 5 days) three weekly, for one year or until recurrence, with doses adjusted for myelosuppression. Patients were randomized to daily (5000 rad in 25 fractions (fr) in 5 weeks) or Q3h (every 3 hours) Cobalt 60 irradiation (3600-4000 rad in 36-40 fr of 100 rad each, given 4 fr per day at 3-hour intervals over two weeks). Steroid therapy (up to 16 mg day dexamethasone) was permitted. Complications were moderate and equivalent in the two groups. No significant survival or toxicity differences were seen between the two groups. Age, initial performance status, and extent of surgical resection were found to be significant (P<0.01) prognostic factors for survival. Median survival of the whole group was 48 weeks with a minimum follow-up of one year. There was no advantage to large radiation fields. The hyperfractionation and daily regimes had similar efficacy and toxicity. Hyperfractionation with chemotherapy offers a useful alternative approach in the management of this disease

The efficiency of sucralfate in corrosive esophagitis: a randomized, prospective study.

Science.gov (United States)

Gümürdülü, Yüksel; Karakoç, Emre; Kara, Banu; Taşdoğan, Burçak Evren; Parsak, Cem Kaan; Sakman, Gürhan

2010-03-01

Ingestion of a chemical agent is a serious problem, and several treatment protocols to prevent stricture formation have been proposed. We conducted a randomized prospective study to evaluate the effectiveness of oral intensive sucralfate plus conventional therapy compared to conventional therapy alone. Fifteen patients with stage 2b and 3 corrosive esophagitis admitted to our gastroenterology, general surgery and intensive care units between 2004 and 2007 were included. Patients were divided into two groups. The patients in the first group (n=8) received intensive sucralfate therapy plus conventional therapy, while the other group (n=7) received only conventional therapy. We performed upper endoscopic procedures on days: 0, 21, 45, 90 and 180 to identify the emergent complications. In the first group, only one patient had stricture formation, allowing passage of a 9.2 mm endoscope and causing no dysphagia, on day 45. There was no progression in the stricture on follow-ups at the 3rd and 6th months. In the second group, 6 patients had stricture formation causing narrowing and dysphagia. Intensive sucralfate therapy may decrease the frequency of stricture formation in patients with advanced corrosive esophagitis. Further studies with large groups of patients are required to confirm our findings.

Cupping for treating neck pain in video display terminal (VDT) users: a randomized controlled pilot trial.

Science.gov (United States)

Kim, Tae-Hun; Kang, Jung Won; Kim, Kun Hyung; Lee, Min Hee; Kim, Jung Eun; Kim, Joo-Hee; Lee, Seunghoon; Shin, Mi-Suk; Jung, So-Young; Kim, Ae-Ran; Park, Hyo-Ju; Hong, Kwon Eui

2012-01-01

This was a randomized controlled pilot trial to evaluate the effectiveness of cupping therapy for neck pain in video display terminal (VDT) workers. Forty VDT workers with moderate to severe neck pain were recruited from May, 2011 to February, 2012. Participants were randomly allocated into one of the two interventions: 6 sessions of wet and dry cupping or heating pad application. The participants were offered an exercise program to perform during the participation period. A 0 to 100 numeric rating scale (NRS) for neck pain, measure yourself medical outcome profile 2 score (MYMOP2 score), cervical spine range of motion (C-spine ROM), neck disability index (NDI), the EuroQol health index (EQ-5D), short form stress response inventory (SRI-SF) and fatigue severity scale (FSS) were assessed at several points during a 7-week period. Compared with a heating pad, cupping was more effective in improving pain (adjusted NRS difference: -1.29 [95% CI -1.61, -0.97] at 3 weeks (p=0.025) and -1.16 [-1.48, -0.84] at 7 weeks (p=0.005)), neck function (adjusted NDI difference: -0.79 [-1.11, -0.47] at 3 (p=0.0039) and 7 weeks (pcupping and 0.91 [0.86, 0.91] with heating pad treatment, p=0.0054). Four participants reported mild adverse events of cupping. Two weeks of cupping therapy and an exercise program may be effective in reducing pain and improving neck function in VDT workers.

Strategies to enhance venous thromboprophylaxis in hospitalized medical patients (SENTRY: a pilot cluster randomized trial

Directory of Open Access Journals (Sweden)

Pai Menaka

2013-01-01

Full Text Available Abstract Background Venous thromboembolism (VTE is a common preventable cause of mortality in hospitalized medical patients. Despite rigorous randomized trials generating strong recommendations for anticoagulant use to prevent VTE, nearly 40% of medical patients receive inappropriate thromboprophylaxis. Knowledge-translation strategies are needed to bridge this gap. Methods We conducted a 16-week pilot cluster randomized controlled trial (RCT to determine the proportion of medical patients that were appropriately managed for thromboprophylaxis (according to the American College of Chest Physician guidelines within 24 hours of admission, through the use of a multicomponent knowledge-translation intervention. Our primary goal was to determine the feasibility of conducting this study on a larger scale. The intervention comprised clinician education, a paper-based VTE risk assessment algorithm, printed physicians’ orders, and audit and feedback sessions. Medical wards at six hospitals (representing clusters in Ontario, Canada were included; three were randomized to the multicomponent intervention and three to usual care (i.e., no active strategies for thromboprophylaxis in place. Blinding was not used. Results A total of 2,611 patients (1,154 in the intervention and 1,457 in the control group were eligible and included in the analysis. This multicomponent intervention did not lead to a significant difference in appropriate VTE prophylaxis rates between intervention and control hospitals (appropriate management rate odds ratio = 0.80; 95% confidence interval: 0.50, 1.28; p = 0.36; intra-class correlation coefficient: 0.022, and thus was not considered feasible. Major barriers to effective knowledge translation were poor attendance by clinical staff at education and feedback sessions, difficulty locating preprinted orders, and lack of involvement by clinical and administrative leaders. We identified several factors that may increase uptake of a VTE

A prospective randomized study comparing percutaneous nephrolithotomy under combined spinal-epidural anesthesia with percutaneous nephrolithotomy under general anesthesia.

Science.gov (United States)

Singh, Vishwajeet; Sinha, Rahul Janak; Sankhwar, S N; Malik, Anita

2011-01-01

A prospective randomized study was executed to compare the surgical parameters and stone clearance in patients who underwent percutaneous nephrolithotomy (PNL) under combined spinal-epidural anesthesia (CSEA) versus those who underwent PNL under general anesthesia (GA). Between January 2008 to December 2009, 64 patients with renal calculi were randomized into 2 groups and evaluated for the purpose of this study. Group 1 consisted of patients who underwent PNL under CSEA and Group 2 consisted of patients who underwent PNL under GA. The operative time, stone clearance rate, visual pain analog score, mean analgesic dose and mean hospital stay were compared amongst other parameters. The difference between visual pain analog score after the operation and the dose of analgesic requirement was significant on statistical analysis between both groups. PNL under CSEA is as effective and safe as PNL under GA. Patients who undergo PNL under CESA require lesser analgesic dose and have a shorter hospital stay. Copyright © 2011 S. Karger AG, Basel.

PRK and butterfly LASEK: prospective, randomized, contralateral eye comparison of epithelial healing and ocular discomfort.

Science.gov (United States)

Ghanem, Vinícius C; Souza, Giselle C; Souza, Denise C; Viese, Juliana M Z; Weber, Sarah L P; Kara-José, Newton

2008-06-01

To compare corneal reepithelialization, pain scores, ocular discomfort, and tear production after photorefractive keratectomy (PRK) and butterfly laser epithelial keratomileusis (LASEK). This prospective, randomized, double-masked study comprised 102 eyes of 51 patients who underwent laser refractive surgery. Each patient was randomized to have one eye operated on with PRK and the other with butterfly LASEK. Patients were followed for 1 year. The mean reepithelialization time in the PRK group was 4.35+/-0.48 days (range: 4 to 5 days) and 4.75+/-0.72 days (range: 4 to 6 days) in the butterfly LASEK group (PPRK was noted (3.31+/-4.09 vs 4.43+/-4.27; P=.18). Schirmer test values were significantly reduced from preoperative levels through 12 months with both PRK (23.6+/-8.1 vs 19.4+/-10.1; P<.002) and butterfly LASEK (22.4+/-8.7 vs 18.9+/-9.7; P=.01); however, no difference between groups was noted at any time. Photorefractive keratectomy showed a modest but statistically significant shorter reepithelialization time and a tendency towards lower pain scores than butterfly LASEK. The reepithelialization time was strongly associated with the duration of surgery in both techniques. A similar reduction of Schirmer test values was observed up to 1 year postoperatively in both groups.

A pilot randomized controlled trial of mindfulness-based stress reduction for caregivers of family members with dementia.

Science.gov (United States)

Brown, Kirk Warren; Coogle, Constance L; Wegelin, Jacob

2016-11-01

The majority of care for those with Alzheimer's disease and other age-related dementias is provided in the home by family members. To date, there is no consistently effective intervention for reducing the significant stress burden of many family caregivers. The present pilot randomized controlled trial tested the efficacy of an adapted, eight-week mindfulness-based stress reduction (MBSR) program, relative to a near structurally equivalent, standard social support (SS) control condition for reducing caregiver stress and enhancing the care giver-recipient relationship. Thirty-eight family caregivers were randomized to MBSR or SS, with measures of diurnal salivary cortisol, and perceived stress, mental health, experiential avoidance, caregiver burden, and relationship quality collected pre- and post-intervention and at three-month follow-up. MBSR participants reported significantly lower levels of perceived stress and mood disturbance at post-intervention relative to SS participants. At three-month follow-up, participants in both treatment conditions reported improvements on several psychosocial outcomes. At follow-up, there were no condition differences on these outcomes, nor did MBSR and SS participants differ in diurnal cortisol response change over the course of the study. Both MBSR and SS showed stress reduction effects, and MBSR showed no sustained neuroendocrine and psychosocial advantages over SS. The lack of treatment condition differences could be attributable to active ingredients in both interventions, and to population-specific and design factors.

Targeting functional fitness, hearing and health-related quality of life in older adults with hearing loss: Walk, Talk 'n' Listen, study protocol for a pilot randomized controlled trial.

Science.gov (United States)

Lambert, Justin; Ghadry-Tavi, Rouzbeh; Knuff, Kate; Jutras, Marc; Siever, Jodi; Mick, Paul; Roque, Carolyn; Jones, Gareth; Little, Jonathan; Miller, Harry; Van Bergen, Colin; Kurtz, Donna; Murphy, Mary Ann; Jones, Charlotte Ann

2017-01-28

Hearing loss (HL) is a disability associated with poorer health-related quality of life including an increased risk for loneliness, isolation, functional fitness declines, falls, hospitalization and premature mortality. The purpose of this pilot trial is to determine the feasibility and acceptability of a novel intervention to reduce loneliness, improve functional fitness, social connectedness, hearing and health-related quality of life in older adults with HL. This 10-week, single-blind, pilot randomized control trial (RCT) will include a convenience sample of ambulatory adults aged 65 years or older with self-reported HL. Following baseline assessments, participants will be randomized to either intervention (exercise, health education, socialization and group auditory rehabilitation (GAR)) or control (GAR only) groups. The intervention group will attend a local YMCA twice a week and the control group once a week. Intervention sessions will include 45 min of strengthening, balance and resistance exercises, 30 min of group walking at a self-selected pace and 60 min of interactive health education or GAR. The control group will attend 60-min GAR sessions. GAR sessions will include education about hearing, hearing technologies, enhancing communication skills, and psychosocial support. Pre-post trial data collection and measures will include: functional fitness (gait speed, 30-s Sit to Stand Test), hearing and health-related quality of life, loneliness, depression, social participation and social support. At trial end, feasibility (recruitment, randomization, retention, acceptability) and GAR will be evaluated. Despite evidence suggesting that HL is associated with declines in functional fitness, there are no studies aimed at addressing functional fitness declines associated with the disability of HL. This pilot trial will provide knowledge about the physical, mental and social impacts on health related to HL as a disability. This will inform the feasibility of a

Sirolimus Associated with Tacrolimus at Low Doses in Elderly Kidney Transplant Patients: A Prospective Randomized Controlled Trial.

Science.gov (United States)

Kojima, Cristiane Akemi; Nga, Hong Si; Takase, Henrique Mochida; Bravin, Ariane Moyses; Martinez Garcia, Márcia de Fátima Faraldo; Garcia, Paula Dalsoglio; Contti, Mariana Moraes; de Andrade, Luis Gustavo Modelli

2018-06-01

There is no consensus on the best immunosuppressive regimen for elderly renal transplant recipients. The objective of this study was to assess cytomegalovirus infection incidence and kidney transplant outcomes in elderly recipients treated with mammalian target of rapamycin inhibitors sirolimus/ tacrolimus at low doses compared with those receiving tacrolimus/mycophenolate sodium. In this single-center prospective randomized study (Trial Registration No. NCT02683291), kidney transplant recipients over 60 years of age were randomly allocated into 2 groups: tacrolimus-sirolimus (21 patients) and tacrolimus-mycophenolate (23 patients). Cytomegalovirus infection rate and patient survival, biopsy-proven acute rejection, and renal function at 12 months were assessed. Cytomegalovirus infection rate was higher in the mycophenolate group (60.9%) than in the sirolimus group (16.7%; P = .004). The rates of biopsy-proven acute rejection, patient survival, graft survival, and estimated glomerular filtration rate over 12 months did not significantly differ between groups. The incidence of cytomegalovirus infection was significantly lower in the sirolimus group. The use of tacrolimus combined with sirolimus in elderly kidney transplant recipients is safe.

Intraoperative discomfort associated with the use of a rotary or reciprocating system: a prospective randomized clinical

Directory of Open Access Journals (Sweden)

Aline Cristine Gomes

2017-05-01

Full Text Available Objectives The aim of this randomized, controlled, prospective clinical study was to evaluate patients' intraoperative discomfort during root canal preparations in which either multi-file rotary (Mtwo or single-file reciprocating (Reciproc systems were used. Materials and Methods Fifty-five adult patients, aged between 25 and 69 years old, with irreversible pulpitis or pulp necrosis participated in this study. Either the mesiobuccal or the distobuccal canals for maxillary molars and either the mesiobuccal or the mesiolingual canals for mandibular molars were randomly chosen to be instrumented with Mtwo multi-file rotary or Reciproc single-file reciprocating systems. Immediately after each canal instrumentation under anesthesia, patient discomfort was assessed using a 1 - 10 visual analog scale (VAS, ranging from ‘least possible discomfort’ (1 to ‘greatest possible discomfort’ (10. The Wilcoxon signed-rank test was used to determine significant differences at p< 0.05. Results Little intraoperative discomfort was found in all cases. No statistically significant differences in intraoperative discomfort between the 2 systems were found (p = 0.660. Conclusions Root canal preparation with multi-file rotary or single-file reciprocating systems had similar and minimal effects on patients' intraoperative discomfort.

Chiropractic manipulation in Adolescent Idiopathic Scoliosis: a pilot study

Directory of Open Access Journals (Sweden)

Stoline Michael R

2006-08-01

Full Text Available Abstract Background Adolescent idiopathic scoliosis (AIS remains the most common deforming orthopedic condition in children. Increasingly, both adults and children are seeking complementary and alternative therapy, including chiropractic treatment, for a wide variety of health concerns. The scientific evidence supporting the use chiropractic intervention is inadequate. The purpose of this study was to conduct a pilot study and explore issues of safety, patient recruitment and compliance, treatment standardization, sham treatment refinement, inter-professional cooperation, quality assurance, and outcome measure selection. Methods Six patients participated in this 6-month study, 5 of whom were female. One female was braced. The mean age of these patients was 14 years, and the mean Cobb angle was 22.2 degrees. The study design was a randomized controlled clinical trial with two independent and blinded observers. Three patients were treated by standard medical care (observation or brace treatment, two were treated with standard medical care plus chiropractic manipulation, and one was treated with standard medical care plus sham manipulation. The primary outcome measure was Cobb, and the psychosocial measure was Scoliosis Quality of Life Index. Results Orthopedic surgeons and chiropractors were easily recruited and worked cooperatively throughout the trial. Patient recruitment and compliance was good. Chiropractic treatments were safely employed, and research protocols were successful. Conclusion Overall, our pilot study showed the viability for a larger randomized trial. This pilot confirms the strength of existing protocols with amendments for use in a full randomized controlled trial. Trial registration This trial has been assigned an international standard randomized controlled trial number by Current Controlled Trials, Ltd. http://www.controlled-trials.com/isrctn/. The number is ISRCTN41221647.

The atrial fibrillation ablation pilot study

DEFF Research Database (Denmark)

Arbelo, Elena; Brugada, Josep; Hindricks, Gerhard

2014-01-01

AIMS: The Atrial Fibrillation Ablation Pilot Study is a prospective registry designed to describe the clinical epidemiology of patients undergoing an atrial fibrillation (AFib) ablation, and the diagnostic/therapeutic processes applied across Europe. The aims of the 1-year follow-up were to analyse...... was achieved in 40.7% of patients (43.7% in paroxysmal AF; 30.2% in persistent AF; 36.7% in long-lasting persistent AF). A second ablation was required in 18% of the cases and 43.4% were under antiarrhythmic treatment. Thirty-three patients (2.5%) suffered an adverse event, 272 (21%) experienced a left atrial...... tachycardia, and 4 patients died (1 haemorrhagic stroke, 1 ventricular fibrillation in a patient with ischaemic heart disease, 1 cancer, and 1 of unknown cause). CONCLUSION: The AFib Ablation Pilot Study provided crucial information on the epidemiology, management, and outcomes of catheter ablation of AFib...

Tolerance and diagnostic accuracy of an abbreviated adenosine infusion for myocardial scintigraphy: a randomized, prospective study.

Science.gov (United States)

Treuth, M G; Reyes, G A; He, Z X; Cwajg, E; Mahmarian, J J; Verani, M S

2001-01-01

The objectives of this study were 2-fold: (1) to determine the tolerance of adenosine perfusion tomography with the use of an abbreviated (3-minute) infusion in comparison to the standard (6-minute) infusion, and (2) to assess the relative diagnostic accuracy of a 3-minute adenosine infusion in patients referred for arteriography. An abbreviated adenosine infusion may decrease the frequency and duration of side effects and be a more cost-effective alternative. We prospectively randomized 599 patients undergoing adenosine myocardial perfusion tomography to either a 3-minute or 6-minute adenosine infusion at 140 microg/kg per minute. Among the 599 enrolled patients, 142 subsequently underwent coronary angiography. Patients randomized to the 3-minute adenosine infusion tolerated the procedure better than those randomized to the standard infusion (P <.01). Flushing, headache, neck pain, and atrioventricular block were all significantly less frequent (P <.01) with the abbreviated infusion. Moreover, patients receiving the abbreviated infusion had less hypotension and tachycardia (P <.05). The sensitivity of the test for detection of coronary artery disease was 88% for both the 3- and 6-minute infusions. In patients with abnormal scan results, perfusion defect size was slightly larger in those receiving a 6-minute infusion versus those receiving a 3-minute infusion (P =.05). An abbreviated 3-minute adenosine infusion, in combination with perfusion tomography, has similar sensitivity for detection of coronary artery disease and is better tolerated than the standard 6-minute infusion.

A Double-Blind, Randomized Pilot Trial of Chromium Picolinate for Overweight Individuals with Binge-Eating Disorder: Effects on Glucose Regulation.

Science.gov (United States)

Sala, Margarita; Breithaupt, Lauren; Bulik, Cynthia M; Hamer, Robert M; La Via, Maria C; Brownley, Kimberly A

2017-03-04

Chromium treatment has been shown to improve glucose regulation in some populations. The purpose of this study was to evaluate whether chromium picolinate (CrPic) supplementation improves glucose regulation in overweight individuals with binge-eating disorder (BED). In this double-blinded randomized pilot trial, participants (N = 24) were randomized to high (HIGH, 1000 mcg/day, n = 8) or moderate (MOD, 600 mcg/day, n = 9) dose of CrPic or placebo (PL, n = 7) for 6 months. Participants completed an oral glucose tolerance test (OGTT) at baseline, 3 months, and 6 months. Fixed effects models were used to estimate mean change in glucose area under the curve (AUC), insulin AUC , and insulin sensitivity index (ISI). Results revealed a significant group and time interaction (p < 0.04) for glucose AUC , with glucose AUC increasing significantly in the PL group (p < 0.02) but decreasing significantly in the MOD group (p < 0.03) at 6 months. Insulin AUC increased significantly over time (main effect, p < 0.02), whereas ISI decreased significantly over time (main effect, p < 0.03). As anticipated, a moderate dose of CrPic was associated with improved glycemic control, whereas PL was associated with decreased glycemic control. It was unexpected that the improved glycemic control seen in the MOD dose group was not seen in the HIGH dose group. However, although participants randomized to the HIGH dose group did not have improved glycemic control, they had better glycemic control than participants randomized to the PL group. These findings support the need for larger trials.

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

Science.gov (United States)

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

2018-01-01

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

Regional hyperthermia combined with radiotherapy for locally advanced non-small cell lung cancers. A multi-institutional prospective randomized trial of the International Atomic Energy Agency

International Nuclear Information System (INIS)

Mitsumori, Michihide; Hiraoka, Masahiro; Zeng Zhifan; Oliynychenko, P.; Park, Jeong-Ho; Choi, Ihl-Bohng; Tatsuzaki, Hideo; Tanaka, Yoshiaki

2007-01-01

An International Atomic Energy Agency (IAEA)-sponsored, multi-institutional prospective randomized trial was conducted to clarify whether the combination of hyperthermia and radiotherapy improves the local response rate of locally advanced non-small cell lung cancer (NSCLC) compared with that obtained by radiotherapy alone. Between October 1998 and April 2002, 80 patients with locally advanced NSCLC were randomized to receive either standard radiation therapy alone (RT) or radiation therapy combined with hyperthermia (RT+HT). The primary endpoint was the local response rate. The secondary endpoints were local progression-free survival and overall survival. The median follow-up period was 204 days for all patients and 450 days for surviving patients. There were no significant differences between the two arms with regard to local response rate (P=0.49) or overall survival rate (P=0.868). However, local progression-free survival was significantly better in the RT+HT arm (P=0.036). Toxicity was generally mild and no grade 3 late toxicity was observed in either arm. Although improvement of local progression-free survival was observed in the RT+HT arm, this prospective randomized study failed to show any substantial benefit from the addition of hyperthermia to radiotherapy in the treatment of locally advanced NSCLC. (author)

Effect of branched chain amino acid enrichment of total parenteral nutrition on nitrogen sparing and clinical outcome of sepsis and trauma: a prospective randomized double blind trial

NARCIS (Netherlands)

von Meyenfeldt, M. F.; Soeters, P. B.; Vente, J. P.; van Berlo, C. L.; Rouflart, M. M.; de Jong, K. P.; van der Linden, C. J.; Gouma, D. J.

1990-01-01

Administration of extra branched chain amino acids (BCAA) has been associated with a nitrogen sparing effect in septic and traumatized patients. Whether nitrogen sparing is associated with decreased morbidity and mortality rates is unknown. We therefore undertook a prospective, randomized, double

Effects of Aromatherapy Massage on Pregnant Women's Stress and Immune Function: A Longitudinal, Prospective, Randomized Controlled Trial.

Science.gov (United States)

Chen, Pao-Ju; Chou, Cheng-Chen; Yang, Luke; Tsai, Yu-Lun; Chang, Yue-Cune; Liaw, Jen-Jiuan

2017-10-01

This study's aims are to examine the effects of aromatherapy massage on women's stress and immune function during pregnancy. This longitudinal, prospective, randomized controlled trial recruited 52 healthy pregnant women from a prenatal clinic in Taipei using convenience sampling. The participants were randomly assigned to the intervention (n = 24) or control (n = 28) group using Clinstat block randomization. The intervention group received 70 min of aromatherapy massage with 2% lavender essential oil every other week (10 times in total) for 20 weeks; the control group received only routine prenatal care. In both groups, participants' salivary cortisol and immunoglobulin A (IgA) levels were collected before and after the intervention group received aromatherapy massage (every month from 16 to 36 weeks gestation) and were analyzed using enzyme-linked immunosorbent assay. The pregnant women in the intervention group had lower salivary cortisol (p aromatherapy massage than those in the control group, which did not receive massage treatment. Comparing the long-term effects of aromatherapy massage on salivary IgA levels between groups at different times, the study found that the pretest salivary IgA levels at 32 (p = 0.002) and 36 (p aromatherapy massage could significantly decrease stress and enhance immune function in pregnant women. The findings can guide clinicians or midwives in providing aromatherapy massage to women throughout the pregnancy.

Inspiratory muscle training in bronchiectasis patients: a prospective randomized controlled study.

Science.gov (United States)

Liaw, Mei-Yun; Wang, Yi-Hsi; Tsai, Yu-Chin; Huang, Kuo-Tung; Chang, Pei-Wen; Chen, Yung-Che; Lin, Meng-Chih

2011-06-01

To investigate the efficacy and feasibility of home-based inspiratory muscle training in patients with bronchiectasis. A prospective, single-blind, randomized, controlled study. Outpatient clinic of a tertiary care medical centre. Twenty-six patients with bronchiectasis were randomly divided into inspiratory muscle training and control groups. In the inspiratory muscle training group (n = 13), the training programme started with an intensity of 30% maximal inspiratory pressure (MIP), which was increased by 2 cmH(2)O each week, for 30 minutes daily, 5 days a week for eight weeks. The control group (n = 13) did not receive inspiratory muscle training. Main outcome measures included spirometry, resting oxyhaemoglobin saturation by pulse oximetry (SpO(2)), lowest SpO(2) and Borg Scale during 6-minute walking tests, 6-minute walking distance (6MWD), 6-minute walking work (6M(work)), MIP, maximal expiratory pressure (MEP) and St George's Respiratory Questionnaire. There were significant differences in change from baseline in 6MWD (411.9 (133.5) vs. 473.2 (117.2) m, P = 0.021), 6M(work) (21 051.0 (8286.7) vs. 23 915.5 (8343.0) kg-m, P = 0.022), MIP (60.8 (21.8) vs. 84.6 (29.0) cmH(2)O, P = 0.004), and MEP (72.3 (31.1) vs. 104.2 (35.7) cmH(2)O, P = 0.004) in the inspiratory muscle training group. Significant improvements in both MIP (23.8 (25.3) vs. 2.3 (16.4) cmH(2)O, adjusted P-value = 0.005) and MEP (31.9 (30.8) vs. 11.5 (20.8) cmH(2)O, adjusted P-value = 0.038) levels after adjusting for age by linear regression analysis were observed between groups. An eight-week home-based inspiratory muscle training is feasible and effective in improving both inspiratory and expiratory muscle strength, but has no effect on respiratory function and quality of life in patients with bronchiectasis.

Mindfulness training and stress reactivity in substance abuse: results from a randomized, controlled stage I pilot study.

Science.gov (United States)

Brewer, Judson A; Sinha, Rajita; Chen, Justin A; Michalsen, Ravenna N; Babuscio, Theresa A; Nich, Charla; Grier, Aleesha; Bergquist, Keri L; Reis, Deidre L; Potenza, Marc N; Carroll, Kathleen M; Rounsaville, Bruce J

2009-01-01

Stress is important in substance use disorders (SUDs). Mindfulness training (MT) has shown promise for stress-related maladies. No studies have compared MT to empirically validated treatments for SUDs. The goals of this study were to assess MT compared to cognitive behavioral therapy (CBT) in substance use and treatment acceptability, and specificity of MT compared to CBT in targeting stress reactivity. Thirty-six individuals with alcohol and/or cocaine use disorders were randomly assigned to receive group MT or CBT in an outpatient setting. Drug use was assessed weekly. After treatment, responses to personalized stress provocation were measured. Fourteen individuals completed treatment. There were no differences in treatment satisfaction or drug use between groups. The laboratory paradigm suggested reduced psychological and physiological indices of stress during provocation in MT compared to CBT. This pilot study provides evidence of the feasibility of MT in treating SUDs and suggests that MT may be efficacious in targeting stress.

Transcranial direct current stimulation (tDCS) for treatment of major depression during pregnancy: study protocol for a pilot randomized controlled trial.

Science.gov (United States)

Vigod, Simone; Dennis, Cindy-Lee; Daskalakis, Zafiris; Murphy, Kellie; Ray, Joel; Oberlander, Tim; Somerton, Sarah; Hussain-Shamsy, Neesha; Blumberger, Daniel

2014-09-18

Women with depression in pregnancy are faced with difficult treatment decisions. Untreated, antenatal depression has serious negative implications for mothers and children. While antidepressant drug treatment is likely to improve depressive symptoms, it crosses the placenta and may pose risks to the unborn child. Transcranial direct current stimulation is a focal brain stimulation treatment that improves depressive symptoms within 3 weeks of treatment by inducing changes to brain areas involved in depression, without impacting any other brain areas, and without inducing changes to heart rate, blood pressure or core body temperature. The localized nature of transcranial direct current stimulation makes it an ideal therapeutic approach for treating depression during pregnancy, although it has never previously been evaluated in this population. We describe a pilot randomized controlled trial of transcranial direct current stimulation among women with depression in pregnancy to assess the feasibility of a larger, multicentre efficacy study. Women over 18 years of age and between 14 and 32 weeks gestation can be enrolled in the study provided they meet diagnostic criteria for a major depressive episode of at least moderate severity and have been offered but refused antidepressant medication. Participants are randomized to receive active transcranial direct current stimulation or a sham condition that is administered in 15 30-minute treatments over three weeks. Women sit upright during treatment and receive obstetrical monitoring prior to, during and after each treatment session. Depressive symptoms, treatment acceptability, and pregnancy outcomes are assessed at baseline (prior to randomization), at the end of each treatment week, every four weeks post-treatment until delivery, and at 4 and 12 weeks postpartum. Transcranial direct current stimulation is a novel therapeutic option for treating depression during pregnancy. This protocol allows for assessment of the

[Ambulatory laparoscopic cholecystectomy by minilaparoscopy versus traditional multiport ambulatory laparoscopic cholecystectomy. Prospective randomized trial].

Science.gov (United States)

Planells Roig, Manuel; Arnal Bertomeu, Consuelo; Garcia Espinosa, Rafael; Cervera Delgado, Maria; Carrau Giner, Miguel

2016-02-01

Difference analysis of ambulatorization rate, pain, analgesic requirements and daily activities recovery in patients undergoing laparoscopic cholecystectomy with standard multiport access (CLMP) versus a minilaparoscopic, 3mm size, technique. Prospective randomized trial of 40 consecutive patients undergoing laparoscopic cholecystectomy. Comparison criteria included predictive ultrasound factors of difficult cholecystectomy, previous history of complicated biliary disease and demographics. Results are analyzed in terms of ambulatorization rate, pain, analgesic requirements, postoperative recovery, technical difficulty, hemorrhage intensity, overnight stay, readmission rate and total or partial conversion. Both procedures were similar in surgery time, technical score and hemorrhage score. MLC was associated with similar ambulatorization rate, 85%, and over-night stay 15%, with only 15% partial conversion rate. MLC showed less postoperative pain (P=.026), less analgesic consumption (P=.006) and similar DAR (P=.879). MLC is similar to CLMP in terms of ambulatorization with less postoperative pain and analgesic requirements without differences in postoperative recovery. Copyright © 2014 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

The Hong Kong vision study: a pilot assessment of visual impairment in adults.

OpenAIRE

Van Newkirk, M R

1997-01-01

PURPOSE: The Hong Kong Adult Vision Pilot Study is a population based study of the distribution and determinants of eye disease in a random sample of the Chinese population age 40 and over. The present pilot study identifies the extent and causes of visual loss using methods developed in the United States and Australia. The pilot study uses the prevalence data to estimate the sample size necessary to predict the size of an effect a larger study may detect and the confidence with which that ef...

Storytelling for promoting colorectal cancer screening among underserved Latina women: a randomized pilot study.

Science.gov (United States)

Larkey, Linda K; Lopez, Ana Maria; Minnal, Archana; Gonzalez, Julie

2009-01-01

In a low socioeconomic-status population of Latina women, we evaluated the potential of storytelling (ST) as a culturally aligned narrative method to promote colorectal cancer (CRC) prevention and screening, compared to a risk tool (RT)-based intervention. Seventy-eight women were randomized in this pilot study to one of two brief interventions to communicate CRC risk reduction options: ST or an RT. Measures of behavioral intentions relative to CRC prevention and screening were obtained following the intervention. Mean scores for intent to obtain and recommend endoscopy to others were significantly better for participants receiving ST than RT (P = .038 and P = .011, respectively). All participants expressed intent to increase fruit and vegetable consumption and physical activity in response to interventions. Post-intervention perceptions of cancer risk and fear of CRC were not significantly different for participants receiving ST compared with RT. Pre- to post-intervention perceptions of risk increased in ST and decreased in RT, while decreases in fear were similar across both intervention groups. Storytelling may be an effective approach for changing CRC risk-related behavioral intentions among Latinas. Mediating factors (such as perceived risk or fear) often used to predict behavior change may not adequately explain the potential persuasive mechanisms of storytelling.

Fostering Self-Compassion and Loving-Kindness in Patients With Borderline Personality Disorder: A Randomized Pilot Study.

Science.gov (United States)

Feliu-Soler, Albert; Pascual, Juan Carlos; Elices, Matilde; Martín-Blanco, Ana; Carmona, Cristina; Cebolla, Ausiàs; Simón, Vicente; Soler, Joaquim

2017-01-01

The aim of this randomized pilot study is to investigate the effects of a short training programme in loving-kindness and compassion meditation (LKM/CM) in patients with borderline personality disorder. Patients were allocated to LKM/CM or mindfulness continuation training (control group). Patients in the LKM/CM group showed greater changes in Acceptance compared with the control group. Remarkable changes in borderline symptomatology, self-criticism and self-kindness were also observed in the LKM/CM group. Mechanistic explanations and therapeutic implications of the findings are discussed. Three weeks of loving-kindness and compassion meditations increased acceptance of the present-moment experience in patients with borderline personality disorder. Significant improvements in the severity of borderline symptoms, self-criticism, mindfulness, acceptance and self-kindness were observed after the LKM/CM intervention. LKM/CM is a promising complementary strategy for inclusion in mindfulness-based interventions and Dialectical Behavioural Therapy for treating core symptoms in borderline personality disorder. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Intravenous paracetamol for relief of pain during transrectal-ultrasound-guided biopsy of the prostate: A prospective, randomized, double-blind, placebo-controlled study

Directory of Open Access Journals (Sweden)

Ozcan Kilic

2015-11-01

Full Text Available Transrectal-ultrasound-guided prostate biopsy (TRUS-PBx is the standard procedure for diagnosing prostate cancer. The procedure does cause some pain and discomfort; therefore, an adequate analgesia is necessary to ensure patient comfort, which can also facilitate good-quality results. This prospective, randomized, double-blinded, placebo-controlled study aimed to determine if intravenous (IV paracetamol can reduce the severity of pain associated with TRUS-PBx. The study included 104 patients, scheduled to undergo TRUS-PBx with a suspicion of prostate cancer, that were prospectively randomized to receive either IV paracetamol (paracetamol group or placebo (placebo group 30 minutes prior to TRUS-PBx. All patients had 12 standardized biopsy samples taken. Pain was measured using a 10-point visual analog pain scale during probe insertion, during the biopsy procedure, and 1 hour postbiopsy. All biopsies were performed by the same urologist, whereas a different urologist administered the visual analog pain scale. There were not any significant differences in age, prostate-specific antigen level, or prostate volume between the two groups. The pain scores were significantly lower during probe insertion, biopsy procedure, and 1 hour postbiopsy in the paracetamol group than in the placebo group. In conclusion, the IV administration of paracetamol significantly reduced the severity of pain associated with TRUS-PBx.

Wii-Fit for Improving Gait and Balance in an Assisted Living Facility: A Pilot Study

Science.gov (United States)

Padala, Kalpana P.; Padala, Prasad R.; Malloy, Timothy R.; Geske, Jenenne A.; Dubbert, Patricia M.; Dennis, Richard A.; Garner, Kimberly K.; Bopp, Melinda M.; Burke, William J.; Sullivan, Dennis H.

2012-01-01

Objectives. To determine the effects on balance and gait of a Wii-Fit program compared to a walking program in subjects with mild Alzheimer's dementia (AD). Methods. A prospective randomized (1 : 1) pilot study with two intervention arms was conducted in an assisted living facility with twenty-two mild AD subjects. In both groups the intervention occurred under supervision for 30 minutes daily, five times a week for eight weeks. Repeated measures ANOVA and paired t-tests were used to analyze changes. Results. Both groups showed improvement in Berg Balance Scale (BBS), Tinetti Test (TT) and Timed Up and Go (TUG) over 8 weeks. However, there was no statistically significant difference between the groups over time. Intragroup analysis in the Wii-Fit group showed significant improvement on BBS (P = 0.003), and TT (P = 0.013). The walking group showed a trend towards improvement on BBS (P = 0.06) and TUG (P = 0.07) and significant improvement in TT (P = 0.06). Conclusion. This pilot study demonstrates the safety and efficacy of Wii-Fit in an assisted living facility in subjects with mild AD. Use of Wii-Fit resulted in significant improvements in balance and gait comparable to those in the robust monitored walking program. These results need to be confirmed in a larger, methodologically sound study. PMID:22745909

Wii-Fit for Improving Gait and Balance in an Assisted Living Facility: A Pilot Study

Directory of Open Access Journals (Sweden)

Kalpana P. Padala

2012-01-01

Full Text Available Objectives. To determine the effects on balance and gait of a Wii-Fit program compared to a walking program in subjects with mild Alzheimer’s dementia (AD. Methods. A prospective randomized (1 : 1 pilot study with two intervention arms was conducted in an assisted living facility with twenty-two mild AD subjects. In both groups the intervention occurred under supervision for 30 minutes daily, five times a week for eight weeks. Repeated measures ANOVA and paired t-tests were used to analyze changes. Results. Both groups showed improvement in Berg Balance Scale (BBS, Tinetti Test (TT and Timed Up and Go (TUG over 8 weeks. However, there was no statistically significant difference between the groups over time. Intragroup analysis in the Wii-Fit group showed significant improvement on BBS (P=0.003, and TT (P=0.013. The walking group showed a trend towards improvement on BBS (P=0.06 and TUG (P=0.07 and significant improvement in TT (P=0.006. Conclusion. This pilot study demonstrates the safety and efficacy of Wii-Fit in an assisted living facility in subjects with mild AD. Use of Wii-Fit resulted in significant improvements in balance and gait comparable to those in the robust monitored walking program. These results need to be confirmed in a larger, methodologically sound study.

The effects of orally administered Beta-glucan on innate immune responses in humans, a randomized open-label intervention pilot-study.

Directory of Open Access Journals (Sweden)

Jenneke Leentjens

Full Text Available To prevent or combat infection, increasing the effectiveness of the immune response is highly desirable, especially in case of compromised immune system function. However, immunostimulatory therapies are scarce, expensive, and often have unwanted side-effects. β-glucans have been shown to exert immunostimulatory effects in vitro and in vivo in experimental animal models. Oral β-glucan is inexpensive and well-tolerated, and therefore may represent a promising immunostimulatory compound for human use.We performed a randomized open-label intervention pilot-study in 15 healthy male volunteers. Subjects were randomized to either the β -glucan (n = 10 or the control group (n = 5. Subjects in the β-glucan group ingested β-glucan 1000 mg once daily for 7 days. Blood was sampled at various time-points to determine β-glucan serum levels, perform ex vivo stimulation of leukocytes, and analyze microbicidal activity.β-glucan was barely detectable in serum of volunteers at all time-points. Furthermore, neither cytokine production nor microbicidal activity of leukocytes were affected by orally administered β-glucan.The present study does not support the use of oral β-glucan to enhance innate immune responses in humans.ClinicalTrials.gov NCT01727895.

Continuous operation of a pilot plant for the production of beryllium oxide

International Nuclear Information System (INIS)

Costa, T.C.; Amaral, S.; Silveira, C.M.S.; Oliveira, A.P. de

1975-01-01

A method of obtaining beryllium oxide with a purity of 99,2% was developed in a pilot plant with a capacity of 7 tons per month destined to operate continuously. The operation market prospects and control of production with the objective of obtaining internacional technical grade beryllium oxide are discussed [pt

Continuous operation of a pilot plant for the production of beryllium oxide

Energy Technology Data Exchange (ETDEWEB)

Costa, T C; Amaral, S; Silveira, C M.S.; de Oliveira, A P [Instituto de Tecnologia, Governador Valadares (Brazil)

1975-12-01

A method of obtaining beryllium oxide with a purity of 99,2% was developed in a pilot plant with a capacity of 7 tons per month destined to operate continuously. The operation market prospects and control of production with the objective of obtaining internacional technical grade beryllium oxide are discussed.

Application of a ketogenic diet in children with autistic behavior: pilot study.

NARCIS (Netherlands)

Evangeliou, A.; Vlachonikolis, I.; Mihailidou, H.; Spilioti, M.; Skarpalezou, A.; Makaronas, N.; Prokopiou, A.; Christodoulou, P.; Liapi-Adamidou, G.; Helidonis, E.; Sbyrakis, S.; Smeitink, J.A.M.

2003-01-01

A pilot prospective follow-up study of the role of the ketogenic diet was carried out on 30 children, aged between 4 and 10 years, with autistic behavior. The diet was applied for 6 months, with continuous administration for 4 weeks, interrupted by 2-week diet-free intervals. Seven patients could

Anterior cervical discectomy with or without fusion with ray titanium cage: a prospective randomized clinical study

DEFF Research Database (Denmark)

Hauerberg, J.; Kosteljanetz, M.; Bøge-Rasmussen, Torben

2008-01-01

STUDY DESIGN: A prospective randomized clinical study. OBJECTIVE: To compare 2 surgical methods in the treatment of cervical radiculopathy caused by hard or soft disc herniation; namely, simple discectomy versus discectomy with an additional interbody fusion with a Ray titanium cage. SUMMARY...... by fusion with a Ray titanium cage (40 patients) or to discectomy alone (46 patients). Clinical and radiologic follow-up was performed 3, 12, and 24 months after surgery. RESULTS: There was no statistically significant difference between the 2 groups concerning self-reported satisfaction or severity of pain...... adjacent disc degeneration or spondylosis were the same in both groups. CONCLUSION: This study showed no statistically significant difference between simple discectomy and discectomy followed by interbody fusion with a titanium cage in the surgical treatment of cervical radiculopathy caused by disc...

The analgesic effect of dexketoprofen when added to lidocaine for intravenous regional anaesthesia: a prospective, randomized, placebo-controlled study.

Science.gov (United States)

Yurtlu, S; Hanci, V; Kargi, E; Erdoğan, G; Köksal, B G; Gül, Ş; Okyay, R D; Ayoğlu, H; Turan, I Ö

2011-01-01

This prospective, randomized, placebo-controlled study evaluated the effects of dexketoprofen as an adjunct to lidocaine in intravenous regional anaesthesia (IVRA) or as a supplemental intravenous (i.v.) analgesic. Patients scheduled for elective hand or forearm soft-tissue surgery were randomly divided into three groups. All 45 patients received 0.5% lidocaine as IVRA. Dexketoprofen was given either i.v. or added into the IVRA solution and the control group received an equal volume of saline both i.v. and as part of the IVRA. The times of sensory and motor block onset, recovery time and postoperative analgesic consumption were recorded. Compared with controls, the addition of dexketoprofen to the IVRA solution resulted in more rapid onset of sensory and motor block, longer recovery time, decreased intra- and postoperative pain scores and decreased paracetamol use. It is concluded that coadministration of dexketoprofen with lidocaine in IVRA improves anaesthetic block and decreases postoperative analgesic requirements.

Effects of Positive Psychology Interventions on Risk Biomarkers in Coronary Patients: A Randomized, Wait-List Controlled Pilot Trial.

Science.gov (United States)

Nikrahan, Gholam Reza; Laferton, Johannes A C; Asgari, Karim; Kalantari, Mehrdad; Abedi, Mohammad Reza; Etesampour, Ali; Rezaei, Abbas; Suarez, Laura; Huffman, Jeff C

2016-01-01

Among cardiac patients, positive psychologic factors are consistently linked with superior clinical outcomes and improvement in key markers of inflammation and hypothalamic-pituitary-adrenal axis functioning. Further, positive psychology interventions (PPI) have effectively increased psychologic well-being in a wide variety of populations. However, there has been minimal study of PPIs in cardiac patients, and no prior study has evaluated their effect on key prognostic biomarkers of cardiac outcome. Accordingly, we investigated the effect of 3 distinct PPIs on risk biomarkers in cardiac patients. In an exploratory trial, 69 patients with recent coronary artery bypass graft surgery or percutaneous intervention were randomized to (1) one of three 6-week in-person PPIs (based on the work of Seligman, Lyubomirsky, or Fordyce) or (2) a wait-list control group. Risk biomarkers were assessed at baseline, postintervention (7 weeks), and at 15-week follow-up. Between-group differences in change from baseline biomarker levels were examined via random effects models. Compared with the control group, participants randomized to the Seligman (B = -2.06; p = 0.02) and Fordyce PPI (B = -1.54; p = 0.04) had significantly lower high-sensitivity C-reactive protein levels at 7 weeks. Further, the Lyubomirsky PPI (B = -245.86; p = 0.04) was associated with a significantly lower cortisol awakening response at 7 weeks when compared with control participants. There were no other significant between-group differences. Despite being an exploratory pilot study with multiple between-group comparisons, this initial trial offers the first suggestion that PPIs might be effective in reducing risk biomarkers in high-risk cardiac patients. Copyright © 2016 The Academy of Psychosomatic Medicine. All rights reserved.

Jail-to-community treatment continuum for adults with co-occurring substance use and mental disorders: study protocol for a pilot randomized controlled trial.

Science.gov (United States)

Van Dorn, Richard A; Desmarais, Sarah L; Rade, Candalyn B; Burris, Elizabeth N; Cuddeback, Gary S; Johnson, Kiersten L; Tueller, Stephen J; Comfort, Megan L; Mueser, Kim T

2017-08-04

Adults with co-occurring mental and substance use disorders (CODs) are overrepresented in jails. In-custody barriers to treatment, including a lack of evidence-based treatment options and the often short periods of incarceration, and limited communication between jails and community-based treatment agencies that can hinder immediate enrollment into community care once released have contributed to a cycle of limited treatment engagement, unaddressed criminogenic risks, and (re)arrest among this vulnerable and high-risk population. This paper describes a study that will develop research and communication protocols and adapt two evidence-based treatments, dual-diagnosis motivational interviewing (DDMI) and integrated group therapy (IGT), for delivery to adults with CODs across a jail-to-community treatment continuum. Adaptations to DDMI and IGT were guided by the Risk-Need-Responsivity model and the National Institute of Corrections' implementation competencies; the development of the implementation framework and communication protocols were guided by the Evidence-Based Interagency Implementation Model for community corrections and the Inter-organizational Relationship model, respectively. Implementation and evaluation of the protocols and adapted interventions will occur via an open trial and a pilot randomized trial. The clinical intervention consists of two in-jail DDMI sessions and 12 in-community IGT sessions. Twelve adults with CODs and four clinicians will participate in the open trial to evaluate the acceptability and feasibility of, and fidelity to, the interventions and research and communication protocols. The pilot controlled trial will be conducted with 60 inmates who will be randomized to either DDMI-IGT or treatment as usual. A baseline assessment will be conducted in jail, and four community-based assessments will be conducted during a 6-month follow-up period. Implementation, clinical, public health, and treatment preference outcomes will be evaluated

Recruitment and accrual of women in a placebo-controlled clinical pilot study on manual therapy.

Science.gov (United States)

Cambron, Jerrilyn A; Hawk, Cheryl; Evans, Roni; Long, Cynthia R

2004-06-01

To investigate the accrual rates and recruitment processes among 3 Midwestern sites during a pilot study on manual therapy for chronic pelvic pain. Multisite pilot study for a randomized, placebo-controlled clinical trial. Three chiropractic institutions in or near major metropolitan cities in the Midwestern United States. Thirty-nine women aged 18 to 45 with chronic pelvic pain of at least 6 months duration, diagnosed by a board certified gynecologist. The method of recruitment was collected for each individual who responded to an advertisement and completed an interviewer-administered telephone screen. Participants who were willing and eligible after 3 baseline visits were entered into a randomized clinical trial. The number of responses and accrual rates were determined for the overall study, each of the 3 treatment sites, and each of the 5 recruitment efforts. In this study, 355 women were screened over the telephone and 39 were randomized, making the rate of randomization approximately 10%. The most effective recruitment methods leading to randomization were direct mail (38%) and radio advertisements (34%). However, success of the recruitment process differed by site. Based on the accrual of this multisite pilot study, a full-scale trial would not be feasible using this study's parameters. However, useful information was gained on recruitment effectiveness, eligibility criteria, and screening protocols among the 3 metropolitan sites.

Resistant metatarsus adductus: prospective randomized trial of casting versus orthosis.

Science.gov (United States)

Herzenberg, John E; Burghardt, Rolf D

2014-03-01

Metatarsus adductus is a common pediatric foot deformity related to intrauterine molding. It is usually a mild deformity that responds well to simple observation or minimal treatment with a home program of stretching. Resistant cases may need a more aggressive approach such as serial casting or special bracing to avoid the need for surgical intervention. We compared clinical outcomes using serial casting with orthoses for resistant metatarsus adductus. We prospectively treated 27 infants (43 feet) between the ages 3 and 9 months who failed home stretching treatment. Patients were randomized to either serial plaster casting or Bebax orthoses. Footprints and simulated weight-bearing anteroposterior and lateral view radiographs were made at entry and follow-up. There was no statistical difference between casting and Bebax for the following parameters: age at study entry, length of treatment, number of clinic visits, follow-up, and follow-up maintenance treatments. Both groups showed improvement in footprint and radiographic measurements post-treatment, without worsening of heel valgus. The Bebax group had greater improvement in the footprint heel bisector measurement than the casting group. The Bebax treatment requires more active parental cooperation. A simulated cost analysis of materials and office visit charges, however, revealed that Bebax treatment was significantly less expensive, about half the cost of casting. Because of the cost savings and virtually identical clinical results, we recommend the Bebax orthosis for resistant metatarsus in pre-walking infants with parents who are compliant. Other considerations include specific insurance plans, which may pay for casts but not orthoses.

Translating a child care based intervention for online delivery: development and randomized pilot study of Go NAPSACC

Directory of Open Access Journals (Sweden)

Dianne S. Ward

2017-11-01

Full Text Available Abstract Background As part of childhood obesity prevention initiatives, Early Care and Education (ECE programs are being asked to implement evidence-based strategies that promote healthier eating and physical activity habits in children. Translation of evidence-based interventions into real world ECE settings often encounter barriers, including time constraints, lack of easy-to-use tools, and inflexible intervention content. This study describes translation of an evidence-based program (NAPSACC into an online format (Go NAPSACC and a randomized pilot study evaluating its impact on centers’ nutrition environments. Methods Go NAPSACC retained core elements and implementation strategies from the original program, but translated tools into an online, self-directed format using extensive input from the ECE community. For the pilot, local technical assistance (TA agencies facilitated recruitment of 33 centers, which were randomized to immediate (intervention, n = 18 or delayed (control, n = 15 access groups. Center directors were oriented on Go NAPSACC tools by their local TA providers (after being trained by researchers, after which they implemented Go NAPSACC independently with minimal TA support. The Environment and Policy Assessment and Observation instrument (self-report, collected prior to and following the 4-month intervention period, was used to assess impact on centers’ nutrition environments. Process data were also collected from a sample of directors and all TA providers to evaluate program usability and implementation. Results Demographic characteristics of intervention and control centers were similar. Two centers did not complete follow-up measures, leaving 17 intervention and 14 control centers in the analytic sample. Between baseline and follow-up, intervention centers improved overall nutrition scores (Cohen’s d effect size = 0.73, p = 0.15, as well as scores for foods (effect size = 0.74, p = 0

Tai-Chi for Residential Patients with Schizophrenia on Movement Coordination, Negative Symptoms, and Functioning: A Pilot Randomized Controlled Trial

Directory of Open Access Journals (Sweden)

Rainbow T. H. Ho

2012-01-01

Full Text Available Objective. Patients with schizophrenia residing at institutions often suffer from negative symptoms, motor, and functional impairments more severe than their noninstitutionalized counterparts. Tai-chi emphasizes body relaxation, alertness, and movement coordination with benefits to balance, focus, and stress relief. This pilot study explored the efficacy of Tai-chi on movement coordination, negative symptoms, and functioning disabilities towards schizophrenia. Methods. A randomized waitlist control design was adopted, where participants were randomized to receive either the 6-week Tai-chi program and standard residential care or only the latter. 30 Chinese patients with schizophrenia were recruited from a rehabilitation residency. All were assessed on movement coordination, negative symptoms, and functional disabilities at baseline, following intervention and 6 weeks after intervention. Results. Tai-chi buffered from deteriorations in movement coordination and interpersonal functioning, the latter with sustained effectiveness 6 weeks after the class was ended. Controls showed marked deteriorations in those areas. The Tai-chi group also experienced fewer disruptions to life activities at the 6-week maintenance. There was no significant improvement in negative symptoms after Tai-chi. Conclusions. This study demonstrated encouraging benefits of Tai-chi in preventing deteriorations in movement coordination and interpersonal functioning for residential patients with schizophrenia. The ease of implementation facilitates promotion at institutional psychiatric services.

Sage tea-thyme-peppermint hydrosol oral rinse reduces chemotherapy-induced oral mucositis: A randomized controlled pilot study.

Science.gov (United States)

Mutluay Yayla, Ezgi; Izgu, Nur; Ozdemir, Leyla; Aslan Erdem, Sinem; Kartal, Murat

2016-08-01

This pilot study aimed to investigate the preventive effect of sage tea-thyme-peppermint hydrosol oral rinse used in conjunction with basic oral care on chemotherapy-induced oral mucositis. An open-label randomized controlled study. Two oncology hospitals in Ankara, Turkey. Patients receiving 5-fluorouracil-based chemotherapy regimens were divided into the intervention group (N=30) and control group (N=30). Basic oral care was prescribed to the control group, while the intervention group was prescribed sage tea-thyme-peppermint hydrosol in addition to basic oral care. All patients were called to assess their compliance with the study instructions on day 5 and 14. Oral mucositis was evaluated using an inspection method or by assessing oral cavity photos based on the World Health Organization oral toxicity scale on day 5 and 14. Most of the patients in the intervention group did not develop oral mucositis on day 5. In addition, the incidence of grade 1 oral mucositis was statistically lower in the intervention group (10%) than the control group (53.3%) on day 5. By day 14, the majority of patients in both the groups had grade 0 oral mucositis. Sage tea-thyme-peppermint hydrosol oral rinse has promising results in alleviating oral mucositis. This hydrosol can be recommended for clinical use as it is well tolerated and cost-effective. However, further randomized controlled trials are needed to support the study. Copyright © 2016 Elsevier Ltd. All rights reserved.

kinesiotaping reduces pain and modulates sensory function in patients with focal dystonia: a randomized crossover pilot study.

Science.gov (United States)

Pelosin, Elisa; Avanzino, Laura; Marchese, Roberta; Stramesi, Paola; Bilanci, Martina; Trompetto, Carlo; Abbruzzese, Giovanni

2013-10-01

Pain is one of the most common and disabling "nonmotor" symptoms in patients with dystonia. No recent study evaluated the pharmacological or physical therapy approaches to specifically treat dystonic pain symptoms. To evaluate the effectiveness of KinesioTaping in patients with cervical dystonia (CD) and focal hand dystonia (FHD) on self-reported pain (primary objective) and on sensory functions (secondary objective). Twenty-five dystonic patients (14 with CD and 11 FHD) entered a randomized crossover pilot study. The patients were randomized to 14-day treatment with KinesioTaping or ShamTaping over neck (in CD) or forearm muscles (in FHD), and after a 30-day washout period, they received the other treatment. The were 3 visual analog scales (VASs) for usual pain, worst pain, and pain relief. Disease severity changes were evaluated by means of the Toronto Western Spasmodic Torticollis Rating Scale (CD) and the Writer's Cramp Rating Scale (FHD). Furthermore, to investigate possible KinesioTaping-induced effects on sensory functions, we evaluated the somatosensory temporal discrimination threshold. Treatment with KinesioTape induced a decrease in the subjective sensation of pain and a modification in the ability of sensory discrimination, whereas ShamTaping had no effect. A significant, positive correlation was found in both groups of patients between the improvement in the subjective sensation of pain and the reduction of somatosensory temporal discrimination threshold values induced by KinesioTaping. These preliminary results suggest that KinesioTaping may be useful in treating pain in patients with dystonia.

Preoperative Radiotherapy in Resectable Rectal Cancer: A Prospective Randomized Study of Two Different Approaches

International Nuclear Information System (INIS)

EITTA, M.A.; EL- WAHIDI, G.F.; FOUDA, M.A.; ABO EL-NAGA, E.M.; GAD EL-HAK, N.

2010-01-01

Preoperative radiotherapy in resectable rectal cancer has a number of potential advantages, most importantly reducing local recurrence, increasing survival and down-staging effect. Purpose: This prospective study was designed to compare between two different approaches of preoperative radiotherapy, either short course or long course radiotherapy. The primary endpoint is to evaluate the local recurrence rate, overall survival (OS) and disease free survival (DFS). The secondary endpoint is to evaluate down staging, treatment toxicity and ability to do sphincter sparing procedure (SSP), aiming at helping in the choice of the optimal treatment modality. Patients and Methods: This is a prospective randomized study of patients with resectable rectal cancer who presented to the department of Clinical Oncology and Nuclear Medicine, Mansoura University during the time period between June 2007 and September 2009. These patients received preoperative radiotherapy and were randomized into two arms: Arm 1, short course (SCRT) 25Gy/week/5 fractions followed by surgery within one week, and arm 2, long course preoperative radiotherapy (LCRT) 45Gy/5 weeks/25 fractions followed by surgery after 4-6 weeks. Adjuvant chemotherapy was given 4-6 weeks after surgery according to the postoperative pathology. Results: After a median follow-up of 18 months (range 6 to 28 months), we studied the patterns of recurrence. Three patients experienced local recurrence (LR), two out of 14 (14.2%) in arm 1 and one out of 15 patients (6.7%) in arm 2, (p=0.598). Three patients developed distant metastases [two in arm 1 (14.2%) and one in arm 2 (6.7%), p=0.598]. Two-year OS rate was 64±3% and 66±2%, (p= 0.389), and the 2-year DFS rate was 61±2% and 83±2% for arms 1 and 2, respectively (p=0.83). Tumor (T) downstaging was more achieved in LCRT arm with a statistically significant difference, but did not reach statistical significance in node (N) down-staging. SSP was more available in LCRT but with no

Effects of a tele-prehabilitation program or an in-person prehabilitation program in surgical candidates awaiting total hip or knee arthroplasty: Protocol of a pilot single blind randomized controlled trial.

Science.gov (United States)

Doiron-Cadrin, Patrick; Kairy, Dahlia; Vendittoli, Pascal-André; Lowry, Véronique; Poitras, Stéphane; Desmeules, François

2016-12-15

The accessibility for total joint arthroplasty often comes up against long wait lists, and may lead to deleterious effects for the awaiting patients. This pilot single blind randomized controlled trial aims to evaluate the impact of a telerehabilitation prehabilitation program before a hip or knee arthroplasty compared to in-person prehabilitation or to usual wait for surgery. Thirty-six patients on a wait list for a total hip or knee arthroplasty will be recruited and randomly assigned to one of three groups. The in-person prehabilitation group (n = 12) will receive a 12-week rehabilitation program (2 sessions/week) including education, exercises of the lower limb and cardiovascular training. Patients in the tele-prehabilitation group (n = 12) will receive the same intervention using a telecommunication software. The control group (n = 12) will be provided with the hospital's usual documentation before surgery. The Lower Extremity Functional Scale (LEFS) will be the primary outcome measure taken at baseline and at 12 weeks. Secondary measures will include self-reported function and quality of life as well as performance tests. A mixed-model, 2-way repeated-measure ANOVA will be used to analyse the effects of the rehabilitation programs. This pilot study is the first to evaluate the feasibility and the impact of a telerehabilitation prehabilitation program for patients awaiting a total joint arthroplasty. The results of this pilot-RCT will set the foundations for further research in the fields of rehabilitation and tele-medicine for patients suffering from lower limb osteoarthritis. ClinicalTrials.gov: NCT02636751.

A Pilot Randomized Trial of a Companion Robot for People With Dementia Living in the Community.

Science.gov (United States)

Liang, Amy; Piroth, Isabell; Robinson, Hayley; MacDonald, Bruce; Fisher, Mark; Nater, Urs M; Skoluda, Nadine; Broadbent, Elizabeth

2017-10-01

To investigate the affective, social, behavioral, and physiological effects of the companion robot Paro for people with dementia in both a day care center and a home setting. A pilot block randomized controlled trial over 12 weeks. Participants were randomized to the intervention (Paro) or control condition (standard care). Two dementia day care centers and participants' homes in Auckland, New Zealand. Thirty dyads (consisting of a care recipient with dementia and their caregiver) took part in this study. All care recipients attended dementia day care centers at Selwyn Foundation and had a formal diagnosis of dementia. Thirty-minute unstructured group sessions with Paro at the day care center were run 2 to 3 times a week for 6 weeks. Participants also had Paro at home for 6 weeks. At the day care centers, observations of the care recipients' behavior, affect, and social responses were recorded using a time sampling method. Observations of interactions with Paro for participants in the intervention were also recorded. Blood pressure and salivary cortisol were collected from care recipients before and after sessions at day care. In the home setting, level of cognition, depressive symptoms, neuropsychiatric symptoms, behavioral agitation, and blood pressure were measured at baseline, 6 weeks, and 12 weeks. Hair cortisol measures were collected at baseline and at 6 weeks. Observations showed that Paro significantly improved facial expressions (affect) and communication with staff (social interaction) at the day care centers. Subanalyses showed that care recipients with less cognitive impairment responded significantly better to Paro. There were no significant differences in care recipient dementia symptoms, nor physiological measures between the intervention and control group. Paro shows promise in enhancing affective and social outcomes for certain individuals with dementia in a community context. Larger randomized controlled trials in community settings, with

Peyton’s four-step approach for teaching complex spinal manipulation techniques – a prospective randomized trial

Directory of Open Access Journals (Sweden)

Gertraud Gradl-Dietsch

2016-11-01

Full Text Available Abstract Background The objectives of this prospective randomized trial were to assess the impact of Peyton’s four-step approach on the acquisition of complex psychomotor skills and to examine the influence of gender on learning outcomes. Methods We randomly assigned 95 third to fifth year medical students to an intervention group which received instructions according to Peyton (PG or a control group, which received conventional teaching (CG. Both groups attended four sessions on the principles of manual therapy and specific manipulative and diagnostic techniques for the spine. We assessed differences in theoretical knowledge (multiple choice (MC exam and practical skills (Objective Structured Practical Examination (OSPE with respect to type of intervention and gender. Participants took a second OSPE 6 months after completion of the course. Results There were no differences between groups with respect to the MC exam. Students in the PG group scored significantly higher in the OSPE. Gender had no additional impact. Results of the second OSPE showed a significant decline in competency regardless of gender and type of intervention. Conclusions Peyton’s approach is superior to standard instruction for teaching complex spinal manipulation skills regardless of gender. Skills retention was equally low for both techniques.

[Assessment of nociceptive suppression in laparoscopic postoperative status: prospective, randomized and comparative study with a control group].

Science.gov (United States)

Jaime, A; Hernández-Favela, P; Zamora, R; Nava, E; Barroso, G; Kably, A

2001-08-01

In recent years endoscopic surgery has became a highly demanded procedure because it is an easy method for diagnosis and treatment in gynecological field. Post-operative pain is considered as a condition in the morbidity status. The objective of this study was to evaluate the nociceptive suppression in laparoscopic surgery. A prospective randomized trial was performed in order to evaluate this condition. A total of 45 patients were included. Three groups were randomized using two different anesthetics applied in the cult-de-sac and uterine-bladder union. Group A (n-15) received bupivacaine, group B (n = 15) ropivacaine and group C (control) saline solution was instilled. The pain was scored using the visual analog scale as same as blood pressure and heart rate in a 15 minute intervals in the recovery room. For study design there were no differences in age, weight, height and body mass index (EMI). The surgical and anesthetic times were similar among groups. However there were significant differences when pain was evaluated. For a less toxic effects and good preventive analgesia we recommend to use ropivacaine in the postoperative status.

A Study on Chocolate Consumption in Prospective Teachers

Science.gov (United States)

Ozgen, Leyla

2016-01-01

This study was planned and conducted to determine the chocolate consumption habits of prospective teachers. The study population was comprised of students attending the Faculty of Education at Gazi University in Ankara and the sample consisted of 251 prospective teachers selected with simple random sampling. 96.4% and 3.6% of the prospective…

Attention Measures of Accuracy, Variability, and Fatigue Detect Early Response to Donepezil in Alzheimer's Disease: A Randomized, Double-blind, Placebo-Controlled Pilot Trial.

Science.gov (United States)

Vila-Castelar, Clara; Ly, Jenny J; Kaplan, Lillian; Van Dyk, Kathleen; Berger, Jeffrey T; Macina, Lucy O; Stewart, Jennifer L; Foldi, Nancy S

2018-04-09

Donepezil is widely used to treat Alzheimer's disease (AD), but detecting early response remains challenging for clinicians. Acetylcholine is known to directly modulate attention, particularly under high cognitive conditions, but no studies to date test whether measures of attention under high load can detect early effects of donepezil. We hypothesized that load-dependent attention tasks are sensitive to short-term treatment effects of donepezil, while global and other domain-specific cognitive measures are not. This longitudinal, randomized, double-blind, placebo-controlled pilot trial (ClinicalTrials.gov Identifier: NCT03073876) evaluated 23 participants newly diagnosed with AD initiating de novo donepezil treatment (5 mg). After baseline assessment, participants were randomized into Drug (n = 12) or Placebo (n = 11) groups, and retested after approximately 6 weeks. Cognitive assessment included: (a) attention tasks (Foreperiod Effect, Attentional Blink, and Covert Orienting tasks) measuring processing speed, top-down accuracy, orienting, intra-individual variability, and fatigue; (b) global measures (Alzheimer's Disease Assessment Scale-Cognitive Subscale, Mini-Mental Status Examination, Dementia Rating Scale); and (c) domain-specific measures (memory, language, visuospatial, and executive function). The Drug but not the Placebo group showed benefits of treatment at high-load measures by preserving top-down accuracy, improving intra-individual variability, and averting fatigue. In contrast, other global or cognitive domain-specific measures could not detect treatment effects over the same treatment interval. The pilot-study suggests that attention measures targeting accuracy, variability, and fatigue under high-load conditions could be sensitive to short-term cholinergic treatment. Given the central role of acetylcholine in attentional function, load-dependent attentional measures may be valuable cognitive markers of early treatment response.

Patient experiences with self-monitoring renal function after renal transplantation: results from a single-center prospective pilot study.

Science.gov (United States)

van Lint, Céline L; van der Boog, Paul Jm; Wang, Wenxin; Brinkman, Willem-Paul; Rövekamp, Ton Jm; Neerincx, Mark A; Rabelink, Ton J; van Dijk, Sandra

2015-01-01

After a kidney transplantation, patients have to visit the hospital often to monitor for early signs of graft rejection. Self-monitoring of creatinine in addition to blood pressure at home could alleviate the burden of frequent outpatient visits, but only if patients are willing to self-monitor and if they adhere to the self-monitoring measurement regimen. A prospective pilot study was conducted to assess patients' experiences and satisfaction. For 3 months after transplantation, 30 patients registered self-measured creatinine and blood pressure values in an online record to which their physician had access to. Patients completed a questionnaire at baseline and follow-up to assess satisfaction, attitude, self-efficacy regarding self-monitoring, worries, and physician support. Adherence was studied by comparing the number of registered with the number of requested measurements. Patients were highly motivated to self-monitor kidney function, and reported high levels of general satisfaction. Level of satisfaction was positively related to perceived support from physicians (Pself-efficacy (Pmonitoring of creatinine and blood pressure after transplantation offers a promising strategy. Important prerequisites for safe implementation in transplant care seem to be support from physicians and patients' confidence in both their own self-monitoring skills and the accuracy of the devices used.

TC-325 versus the conventional combined technique for endoscopic treatment of peptic ulcers with high-risk bleeding stigmata: A randomized pilot study.

Science.gov (United States)

Kwek, Boon Eu Andrew; Ang, Tiing Leong; Ong, Peng Lan Jeannie; Tan, Yi Lyn Jessica; Ang, Shih Wen Daphne; Law, Ngai Moh; Thurairajah, Prem Harichander; Fock, Kwong Ming

2017-06-01

Preliminary studies on a new topical hemostatic agent, TC-325, have shown its safety and effectiveness in treating active upper gastrointestinal (GI) bleeding. However, to date there have been no randomized trials comparing TC-325 with the conventional combined technique (CCT). Our pilot study aimed to compare the efficacy and safety of TC-325 with those of CCT in treating peptic ulcers with active bleeding or high-risk stigmata. This was a comparative randomized study of patients with upper GI bleeding who had Forrest class I, IIA or IIB ulcers. Altogether 20 patients with a mean age of 70 years (range 23-87 years) were recruited, including 16 men, with a mean hemoglobin of 97 g/L. Initial hemostasis was successful in 19 (95.0%) patients, including 90.0% (9/10) in the TC-325 group and 100% (10/10) in the CCT group. TC-325 monotherapy failed to stop bleeding in a patient with Forrest IB posterior duodenal wall ulcer. Rebleeding was seen in 33.3% (3/9) of the patients in the TC-325 group and 10.0% (1/10) in the CCT group. One patient required angio-embolization therapy while three had successful conventional endotherapy. Two patients from the TC-325 group had serious adverse events that were not procedure- or therapy-related. In patients with Forrest IIA or IIB ulcers, five received TC-325 monotherapy; none had rebleeding. Our pilot study showed that TC-325 has a tendency towards a higher rebleeding rate than CCT, when treating actively bleeding ulcers. Larger trials are necessary for definitive results. © 2017 Chinese Medical Association Shanghai Branch, Chinese Society of Gastroenterology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.

Integrated geophysical-geochemical methods for archaeological prospecting

OpenAIRE

Persson, Kjell

2005-01-01

A great number of field measurements with different methods and instruments were conducted in attempts to develop a method for an optimal combination of various geochemical and geophysical methods in archaeological prospecting. The research presented in this thesis focuses on a study of how different anthropogenic changes in the ground can be detected by geochemical and geophysical mapping and how the results can be presented. A six-year pilot project, Svealand in Vendel and Viking periods (S...

A dual-task home-based rehabilitation programme for improving balance control in patients with acquired brain injury: a single-blind, randomized controlled pilot study.

Science.gov (United States)

Peirone, Eliana; Goria, Paolo Filiberto; Anselmino, Arianna

2014-04-01

To evaluate the safety, feasibility and effectiveness of a dual-task home-based rehabilitation programme on balance impairments among adult patients with acquired brain injury. Single-blind, randomized controlled pilot study. Single rehabilitation centre. Sixteen participants between 12 and 18 months post-acquired brain injury with balance impairments and a score task home-based programme six days a week for seven weeks. The primary outcome measure was the Balance Evaluation System Test; secondary measures were the Activities-specific Balance Confidence Scale and Goal Attainment Scaling. At the end of the pilot study, the intervention group showed significantly greater improvement in Balance Evaluation System Test scores (17.87, SD 6.05) vs. the control group (5.5, SD 3.53; P = 0.008, r = 0.63). There was no significant difference in improvement in Activities-specific Balance Confidence Scale scores between the intervention group (25.25, SD 25.51) and the control group (7.00, SD 14.73; P = 0.11, r = 0.63). There was no significant improvement in Goal Attainment Scaling scores in the intervention (19.37, SD 9.03) vs. the control group (16.28, SD 6.58; P = 0.093, r = 0.63). This pilot study shows the safety, feasibility and short-term benefit of a dual-task home-based rehabilitation programme to improve balance control in patients with acquired brain injury. A sample size of 26 participants is required for a definitive study.

Influence of inhomogeneous static magnetic field-exposure on patients with erosive gastritis: a randomized, self- and placebo-controlled, double-blind, single centre, pilot study.

Science.gov (United States)

Juhász, Márk; Nagy, Viktor L; Székely, Hajnal; Kocsis, Dorottya; Tulassay, Zsolt; László, János F

2014-09-06

This pilot study was devoted to the effect of static magnetic field (SMF)-exposure on erosive gastritis. The randomized, self- and placebo-controlled, double-blind, pilot study included 16 patients of the 2nd Department of Internal Medicine, Semmelweis University diagnosed with erosive gastritis. The instrumental analysis followed a qualitative (pre-intervention) assessment of the symptoms by the patient: lower heartburn (in the ventricle), upper heartburn (in the oesophagus), epigastric pain, regurgitation, bloating and dry cough. Medical diagnosis included a double-line upper panendoscopy followed by 30 min local inhomogeneous SMF-exposure intervention at the lower sternal region over the stomach with peak-to-peak magnetic induction of 3 mT and 30 mT m(-1) gradient at the target site. A qualitative (post-intervention) assessment of the same symptoms closed the examination. Sham- or SMF-exposure was used in a double-blind manner. The authors succeeded in justifying the clinically and statistically significant beneficial effect of the SMF- over sham-exposure on the symptoms of erosive gastritis, the average effect of inhibition was 56% by p = 0.001, n = 42 + 96. This pilot study was aimed to encourage gastroenterologists to test local, inhomogeneous SMF-exposure on erosive gastritis patients, so this intervention may become an evidence-based alternative or complementary method in the clinical use especially in cases when conventional therapy options are contraindicated. © 2014 The Author(s) Published by the Royal Society. All rights reserved.

Peroral endoscopic myotomy for the treatment of achalasia: an international prospective multicenter study

NARCIS (Netherlands)

von Renteln, Daniel; Fuchs, Karl-Hermann; Fockens, Paul; Bauerfeind, Peter; Vassiliou, Melina C.; Werner, Yuki B.; Fried, Gerald; Breithaupt, Wolfram; Heinrich, Henriette; Bredenoord, Albert J.; Kersten, Jan F.; Verlaan, Tessa; Trevisonno, Michael; Rösch, Thomas

2013-01-01

Pilot studies have indicated that peroral endoscopic myotomy (POEM) might be a safe and effective treatment for achalasia. We performed a prospective, international, multicenter study to determine the outcomes of 70 patients who underwent POEM at 5 centers in Europe and North America. Three months

Effects of tai chi qigong on psychosocial well-being among hidden elderly, using elderly neighborhood volunteer approach: a pilot randomized controlled trial

Directory of Open Access Journals (Sweden)

Chan AW

2017-01-01

Full Text Available Aileen WK Chan, Doris SF Yu, KC Choi The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, NT, Hong Kong SAR Purpose: To test the feasibility and preliminary effectiveness of a tai chi qigong program with the assistance of elderly neighborhood volunteers in strengthening social networks and enhancing the psychosocial well-being of hidden elderly. Patients and methods: “Hidden elderly” is a term used to describe older adults who are socially isolated and refuse social participation. This pilot randomized controlled trial recruited 48 older adults aged 60 or above who did not engage in any social activity. They were randomized into tai chi qigong (n=24 and standard care control (n=24 groups. The former group underwent a three-month program of two 60-minute sessions each week, with the socially active volunteers paired up with them during practice. Standard care included regular home visits by social workers. Primary outcomes were assessed by means of the Lubben social network and De Jong Gieveld loneliness scales, and by a revised social support questionnaire. Secondary outcomes were covered by a mental health inventory and the Rosenberg self-esteem scale, and quality of life by using the 12-Item Short Form Health Survey. Data was collected at baseline, and at three and six months thereafter. Results: The generalized estimating equations model revealed general improvement in outcomes among participants on the tai chi qigong program. In particular, participants reported a significantly greater improvement on the loneliness scale (B=-1.32, 95% confidence interval [CI] -2.54 to -0.11, P=0.033 and the satisfaction component of the social support questionnaire (B=3.43, 95% CI 0.10–6.76, P=0.044 than the control group. Conclusion: The pilot study confirmed that tai chi qigong with elderly neighborhood volunteers is a safe and feasible social intervention for hidden elderly. Its potential benefits in

An innovative acupuncture treatment for primary dysmenorrhea: a randomized cross-over pilot study

Science.gov (United States)

Wade, Christine M.; Abercrombie, Priscilla D.; Gomolak, Denise

2013-01-01

Background/Objective Dysmenorrhea is highly prevalent among adolescent women and a major cause of activity restriction. Standard pharmaceuticals used to treat dysmenorrhea are not effective for all women and have side effects that limit their use. Our study objective was to examine feasibility, acceptability, and preliminary effects of acupuncture point injection of vitamin K1 as an alternative treatment for primary dysmenorrhea among US women. Methods/Design We conducted a pilot study using a crossover trial design. Women with primary dysmenorrhea were randomized to receive vitamin K1 injection in the Spleen-6 acupuncture point at the start of menstruation followed by saline in a non-acupuncture point after two months, or the reverse order of treatments. Setting/Participants The study was conducted in the San Francisco Bay Area among women 18 and 25 years of age diagnosed with primary dysmenorrhea; fourteen women completed all study visits. Primary Outcome Measure Dysmenorrhea pain intensity was measured using a 0–10 numeric rating scale before and after injections. Results Women had an average 2.5 point decrease in pain after vitamin K1 injection in Spleen-6 (p dysmenorrhea among young women in San Francisco. Pain decreased with both treatments, with a trend toward greater pain reduction for vitamin K1/Spleen-6 injection. This is consistent with outcomes from the Obstetrics & Gynecology Hospital in Shanghai, China, where the protocol was developed. PMID:24445356

Increasing patient involvement in the diabetic foot pathway: a pilot randomized controlled trial.

Science.gov (United States)

McBride, E; Hacking, B; O'Carroll, R; Young, M; Jahr, J; Borthwick, C; Callander, A; Berrada, Z

2016-11-01

This pilot study aimed to explore whether the use of an intervention to increase shared decision-making (Decision Navigation) increased decision self-efficacy and foot-treatment adherence in patients with a diabetic foot ulcer. Fifty-six patients with a diabetic foot ulcer were randomized to receive Decision Navigation (N = 30) or usual care (N = 26). Primary outcomes included decision self-efficacy, adherence to foot treatment as reported by the participant and adherence to foot treatment as reported by the clinician. Secondary outcomes included foot ulcer healing rate, health-related quality of life, decision conflict and decision regret. Despite participants rating Decision Navigation as very helpful, mixed analyses of variance revealed no differences in decision self-efficacy or adherence between those receiving Decision Navigation and those receiving usual care. There were no differences between groups with regards to the secondary outcomes, with the exception of decision conflict which increased over time (12 weeks) for those receiving Decision Navigation. An intervention that facilitated patient involvement in treatment decisions did not have any impact on decisional confidence or adherence to foot treatment. This does not provide support for the suggestion that personalized care can improve health-related outcomes at this progressed stage of the patient's disease trajectory. We suggest that the diabetic foot population may benefit from interventions aimed at increasing motivation to engage with care pathways, centred on challenging personal controllability beliefs. © 2016 Diabetes UK.

A Randomized Pilot Study of a Phone-Based Mindfulness and Weight Loss Program.

Science.gov (United States)

Carpenter, Kelly M; Vickerman, Katrina A; Salmon, Erica E; Javitz, Harold S; Epel, Elissa S; Lovejoy, Jennifer C

2017-10-06

This study evaluated the feasibility and efficacy of integrating mindfulness training into a phone-based weight loss program to improve outcomes in those with high levels of emotional eating. Participants were 75 enrollees into an employer-sponsored weight loss program who reported high levels of overeating in response to thoughts and feelings. Seventy-five overweight and obese participants (92% female, 65% Caucasian, aged 26 to 68 years) were randomized to the new mindfulness weight loss program (n = 50) or the standard behavioral weight loss program (n = 25). Both programs consisted of 11 coaching calls with health coaches and registered dietitians with supplemental online materials. Satisfaction, engagement, and percent weight lost did not significantly differ for intervention vs. control at six months. Intervention participants had significantly better scores at six-month follow-up on mindful eating, binge eating, experiential avoidance, and one mindfulness subscale. Exploratory analyses showed that improvements on several measures predicted more weight loss in the intervention group. This pilot study found that integrating mindfulness into a brief phone-based behavioral weight loss program was feasible and acceptable to participants, but did not produce greater weight loss on average, despite hypothesized changes in mindful eating. Only one third of intervention participants reported participating in mindfulness exercises regularly. Mechanisms of change observed within the intervention group suggest that for adults with high levels of emotional eating those who embrace mindful eating and meditation may lose more weight with a mindfulness intervention.

The use of school teachers to promote oral hygiene in some secondary school students at Hyderabad, Andhra Pradesh, India: A short term prospective pilot study

Directory of Open Access Journals (Sweden)

Byalakere R Chandrashekar

2012-01-01

Full Text Available Study design : It was a short term prospective pilot study on a group of 116 secondary school students. Objectives: To assess the feasibility of using the services of school teachers to promote oral hygiene in secondary school students and compare the effectiveness of dental health education (DHE offered by school teachers on a fortnightly basis with what is offered by dental professionals at three- monthly intervals. Materials and Methods: Six secondary schools were randomly selected. The base-line Oral Hygiene Index simplified (OHI-S and Plaque index (PI scores for all the students were recorded. The teachers were trained on dental health facts. The six schools were divided into three groups of two schools with different intervention techniques: Group 1- Schools given no health education, Group 2 - Schools given health education by their school teachers on a fortnightly basis together with simple screening for deposits of gross calculus , Group 3 - Schools which were given health education by dental professionals at intervals of three months without any screening. Grade nine students were selected for pre and post intervention evaluation. The second examination was done six months following the intervention to find out the OHI-S and Plaque index scores. The examination was done by three trained and calibrated dentists. Data analysis was done with SPSS 16 with relevant statistical tests. Results: The mean OHI-S and PI scores were significantly less in group 2 and there was a statistically significant difference between the baseline OHI - S, PI score and the scores after six months in all the three groups. Conclusion: The concept of utilizing the teachers for frequent DHE and screening for any gross deposits of food debris and calculus is feasible. Also frequent DHE by teachers was more effective than the infrequent DHE by the professionals.

Randomized controlled pilot study of an educational video plus telecare for the early outpatient management of musculoskeletal pain among older emergency department patients.

Science.gov (United States)

Platts-Mills, Timothy F; Hollowell, Allison G; Burke, Gary F; Zimmerman, Sheryl; Dayaa, Joseph A; Quigley, Benjamin R; Bush, Montika; Weinberger, Morris; Weaver, Mark A

2018-01-05

Musculoskeletal pain is a common reason for emergency department (ED) visits. Following discharge from the ED, patients, particularly older patients, often have difficulty controlling their pain and managing analgesic side effects. We conducted a pilot study of an educational video about pain management with and without follow-up telephone support for older adults presenting to the ED with musculoskeletal pain. ED patients aged 50 years and older with musculoskeletal pain were randomized to: (1) usual care, (2) a brief educational video only, or (3) a brief educational video plus a protocol-guided follow-up telephone call from a physician 48-72 hours after discharge (telecare). The primary outcome was the change from the average pain severity before the ED visit to the average pain severity during the past week assessed one month after the ED visit. Pain was assessed using a 0-10 numerical rating scale. Of 75 patients randomized (mean age 64 years), 57 (76%) completed follow up at one month. Of the 18 patients lost to follow up, 12 (67%) had non-working phone numbers. Among patients randomized to the video (arms 2 and 3), 46/50 viewed the entire video; among the 25 patients randomized to the video plus telecare (arm 3), 23 were reached for telecare. Baseline pain scores for the usual care, video, and video plus telecare groups were 7.3, 7.1, and 7.5. At one month, pain scores were 5.8, 4.9, and 4.5, corresponding to average decreases in pain of -1.5, -2.2, and -3.0, respectively. In the pairwise comparison between intervention groups, the video plus telecare group had a 1.7-point (95% CI 1.2, 2.1) greater decrease in pain compared to usual care, and the video group had a 1.1-point (95% CI 0.6, 1.6) greater decrease in pain compared to usual care after adjustment for baseline pain, age, and gender. At one month, clinically important differences were also observed between the video plus telecare and usual care groups for analgesic side effects, ongoing opioid use

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

Science.gov (United States)

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

2015-01-01

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

Timing of urinary catheter removal after uncomplicated total abdominal hysterectomy: a prospective randomized trial.

Science.gov (United States)

Ahmed, Magdy R; Sayed Ahmed, Waleed A; Atwa, Khaled A; Metwally, Lobna

2014-05-01

To assess whether immediate (0h), intermediate (after 6h) or delayed (after 24h) removal of an indwelling urinary catheter after uncomplicated abdominal hysterectomy can affect the rate of re-catheterization due to urinary retention, rate of urinary tract infection, ambulation time and length of hospital stay. Prospective randomized controlled trial conducted at Suez Canal University Hospital, Egypt. Two hundred and twenty-one women underwent total abdominal hysterectomy for benign gynecological diseases and were randomly allocated into three groups. Women in group A (73 patients) had their urinary catheter removed immediately after surgery. Group B (81 patients) had the catheter removed 6h post-operatively while in group C (67 patients) the catheter was removed after 24h. The main outcome measures were the frequency of urinary retention, urinary tract infections, ambulation time and length of hospital stay. There was a significantly higher number of urinary retention episodes requiring re-catheterization in the immediate removal group compared to the intermediate and delayed removal groups (16.4% versus 2.5% and 0% respectively). Delayed urinary catheter removal was associated with a higher incidence of urinary tract infections (15%), delayed ambulation time (10.3h) and longer hospital stay (5.6 days) compared to the early (1.4%, 4.1h and 3.2 days respectively) and intermediate (3.7%, 6.8h and 3.4 days respectively) removal groups. Removal of the urinary catheter 6h postoperatively appears to be more advantageous than early or late removal in cases of uncomplicated total abdominal hysterectomy. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Portable Weather Applications for General Aviation Pilots.

Science.gov (United States)

Ahlstrom, Ulf; Ohneiser, Oliver; Caddigan, Eamon

2016-09-01

The objective of this study was to examine the potential benefits and impact on pilot behavior from the use of portable weather applications. Seventy general aviation (GA) pilots participated in the study. Each pilot was randomly assigned to an experimental or a control group and flew a simulated single-engine GA aircraft, initially under visual meteorological conditions (VMC). The experimental group was equipped with a portable weather application during flight. We recorded measures for weather situation awareness (WSA), decision making, cognitive engagement, and distance from the aircraft to hazardous weather. We found positive effects from the use of the portable weather application, with an increased WSA for the experimental group, which resulted in credibly larger route deviations and credibly greater distances to hazardous weather (≥30 dBZ cells) compared with the control group. Nevertheless, both groups flew less than 20 statute miles from hazardous weather cells, thus failing to follow current weather-avoidance guidelines. We also found a credibly higher cognitive engagement (prefrontal oxygenation levels) for the experimental group, possibly reflecting increased flight planning and decision making on the part of the pilots. Overall, the study outcome supports our hypothesis that portable weather displays can be used without degrading pilot performance on safety-related flight tasks, actions, and decisions as measured within the constraints of the present study. However, it also shows that an increased WSA does not automatically translate to enhanced flight behavior. The study outcome contributes to our knowledge of the effect of portable weather applications on pilot behavior and decision making. © 2016, Human Factors and Ergonomics Society.

Effect of continuous oral suctioning on the development of ventilator-associated pneumonia: a pilot randomized controlled trial.

Science.gov (United States)

Chow, Meyrick C M; Kwok, Shu-Man; Luk, Hing-Wah; Law, Jenny W H; Leung, Bartholomew P K

2012-11-01

Both continuous and intermittent aspiration of subglottic secretions by means of specially designed endotracheal tubes containing a separate dorsal lumen that opens into the subglottic region have been shown to be useful in reducing ventilator-associated pneumonia (VAP). However, the high cost of these tubes restricts their use. The aim of this pilot randomized controlled trial was to test the effect of a low-cost device (saliva ejector) for continuous oral suctioning (COS) on the incidence of VAP in patients receiving mechanical ventilation. The study was conducted in the six-bed medical-surgical ICU of a hospital with over 400 beds that provides comprehensive medical services to the public. The design of this study was a parallel-group randomized controlled trial. While both the experimental and control groups used the conventional endotracheal tube, the saliva ejector was only applied to patients assigned to the experimental group. The device was put between the patient's cheek and teeth, and then connected to 100mmHg of suction for the continuous drainage of saliva. Fourteen patients were randomized to receive COS and 13 patients were randomized to the control group. The two groups were similar in demographics, reasons for intubation, co-morbidity, and risk factors for acquiring VAP. VAP was found in 3 patients (23.1%; 71 episodes of VAP per 1000 ventilation days) receiving COS and in 10 patients (83.3%; 141 episodes of VAP per 1000 ventilation days) in the control group (relative risk, 0.28; 95% confidence interval, 0.10-0.77; p=0.003). The duration of mechanical ventilation in the experimental group was 3.2 days (SD 1.3), while that in the control group was 5.9 days (SD 2.8) (p=0.009); and the length of ICU stay was 4.8 days (SD 1.6) versus 9.8 days (SD 6.3) for the experimental and control groups, respectively (p=0.019). Continuous clearance of oral secretion by the saliva ejector may have an important role to play in reducing the rate of VAP, decreasing the

β-trace protein as a diagnostic marker for perilymphatic fluid fistula: a prospective controlled pilot study to test a sample collection technique.

Science.gov (United States)

Bachmann-Harildstad, Gregor; Stenklev, Niels Christian; Myrvoll, Elin; Jablonski, Greg; Klingenberg, Olav

2011-01-01

The diagnosis of perilymphatic fluid (PLF) fistula is still challenging. Perilymphatic fluid fistula is one possible complication after stapedotomy or cochlear implant surgery. We have performed a prospective diagnostic pilot study to further investigate β-trace protein (β-TP) as a marker for PLF fistula. In this pilot study, we tested the sensitivity of the β-TP marker using a simple method for sample collection from the tympanic cavity. Prospective controlled diagnostic study. Two-center tertiary referral hospitals. A total of 35 adult patients undergoing ear surgery were included. Subjects were divided into 2 groups: 1) 19 patients undergoing stapedotomy were investigated for PLF fistula in samples obtained from the tympanic cavity and 2) 16 patients undergoing myringoplasty were investigated for PLF fistula in samples from the tympanic cavity. This group served as the control. Mean age +/- SD at surgery was 49.9 +/- 8.0 years in the study group and 39.69 +/- 15.47 years in the control group. β-Trace protein (prostaglandin D synthase) in tympanic cavity samples and serum samples was analyzed. The samples were collected by gradually filling the tympanic cavity with 100 to 200 μl sodium chloride and by immediately collecting a volume of 60 to 100 μl in a mucus specimen set container. The concentration of β-TP was quantified using laser nephelometry. The median β-TP in the study group was 0.8 mg/L (range, 0.05-4.5 mg/L). In the control group, the median β-TP value was 0.16 mg/L (range, 0.01-0.36 mg/L). Thirty-five percent of the values in the study group were below the highest value in the negative control group. The β-TP values of the tympanic cavity samples were significantly higher in the study group than in controls (p = 0.0001). The serum values were 0.55 +/- 0.18 and 0.53 +/- 0.11 mg/L, respectively. It may be feasible to test for PLF fistula using β-TP in samples from the tympanic cavity. Our results, however, suggest a relative low diagnostic

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

Science.gov (United States)

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

2017-08-01

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

Recruitment of Participants and Delivery of Online Mental Health Resources for Depressed Individuals Using Tumblr: Pilot Randomized Control Trial.

Science.gov (United States)

Kelleher, Erin; Moreno, Megan; Wilt, Megan Pumper

2018-04-12

Adolescents and young adults frequently post depression symptom references on social media; previous studies show positive associations between depression posts and self-reported depression symptoms. Depression is common among young people and this population often experiences many barriers to mental health care. Thus, social media may be a new resource to identify, recruit, and intervene with young people at risk for depression. The purpose of this pilot study was to test a social media intervention on Tumblr. We used social media to identify and recruit participants and to deliver the intervention of online depression resources. This randomized pilot intervention identified Tumblr users age 15-23 who posted about depression using the search term "#depress". Eligible participants were recruited via Tumblr messages; consented participants completed depression surveys and were then randomized to an intervention of online mental health resources delivered via a Tumblr message, while control participants did not receive resources. Postintervention online surveys assessed resource access and usefulness and control groups were asked whether they would have liked to receive resources. Analyses included t tests. A total of 25 participants met eligibility criteria. The mean age of the participants was 17.5 (SD 1.9) and 65% were female with average score on the Patient Health Questionnaire-9 of 17.5 (SD 5.9). Among the 11 intervention participants, 36% (4/11) reported accessing intervention resources and 64% (7/11) felt the intervention was acceptable. Among the 14 control participants, only 29% (4/14) of reported that receiving resources online would be acceptable (P=.02). Participants suggested anonymity and ease of use as important characteristics in an online depression resource. The intervention was appropriately targeted to young people at risk for depression, and recruitment via Tumblr was feasible. Most participants in the intervention group felt the social media

Efficacy and safety of two different n-butyl-2-cyanoacrylates for the embolization of varicoceles: a prospective, randomized, blinded study.

Science.gov (United States)

Vanlangenhove, Peter; De Keukeleire, Katrien; Everaert, Karel; Van Maele, Georges; Defreyne, Luc

2012-06-01

This was a prospective, randomized, blinded comparative study of the efficacy and safety of two different n-butyl-2-cyanoacrylates (NBCAs) for embolization of varicoceles. A total of 112 insufficient spermatic veins (left-sided, n=84; right-sided, n=28) that were diagnosed in 83 adult males were prospectively randomized for blinded embolization with NBCA (n=54; Histoacryl, Braun, Germany) or NBCA-MS (n=58; Glubran2, General Enterprise Marketing, Viareggio, Lucca, Italy). Handling, embolic efficacy, and safety of both NBCAs were compared according the fulfillment of a standardized embolization plan, the occlusive effect on the spermatic vein, and the sticking to the microcatheter. Statistical analysis was performed with the Mann-Whitney U test and the Fisher's exact test. Patients of both study arms were comparable for age and clinical indication. Spermatic vein characteristics were comparable for varicocele classification and embolization side. Both NBCAs were equally efficient in occluding the spermatic vein and blocking reflux (NBCA, n=54/54, 100% vs. NBCA-MS, n=54/57, 94.7%; P=0.244). The embolization plan could be accomplished in an equal number of veins for both groups (NBCA, n=45/54, 83.3% vs. NBCA-MS, n=41/58, 70.7%; P=0.124). Adhesiveness of the glue to the microcatheter was the same in both NBCA groups (NBCA, n=25/54, 46.3% vs. NBCA-MS, n=29/58, 50%; P=0.71). No glue-related complications were noted. NBCA and NBCA-MS are equally efficient and safe glues for embolization of varicoceles.

Fractionated bipolar radiofrequency and bipolar radiofrequency potentiated by infrared light for treating striae: A prospective randomized, comparative trial with objective evaluation.

Science.gov (United States)

Harmelin, Yona; Boineau, Dominique; Cardot-Leccia, Nathalie; Fontas, Eric; Bahadoran, Philippe; Becker, Anne-Lise; Montaudié, Henri; Castela, Emeline; Perrin, Christophe; Lacour, Jean-Philippe; Passeron, Thierry

2016-03-01

Very few treatments for striae are based on prospective randomized trials. The objective of this study was to assess the efficacy of bipolar fractional radiofrequency and bipolar radiofrequency potentiated with infrared light, alone or combined, for treating abdominal stretch marks. Bicentric prospective interventional randomized controlled trial in the department of Dermatology of University Hospital of Nice and Aesthetics Laser Center of Bordeaux, France. Men and women of age 18 years or above, who presented for the treatment of mature or immature abdominal striae were included. The patients' abdomens were divided into four equal quadrants. Bipolar radiofrequency potentiated with infrared light and fractional bipolar radiofrequency were applied, alone or combined, and compared to the remaining untreated quadrant. The main criterion of evaluation was the measurement of depth of striae, using 3D photography at 6 months follow-up. A global assessment was also rated by the physician performing the treatment and by the patients. Histological analysis and confocal laser microscopy were additionally performed. A total of 22 patients were enrolled, and 384 striae were measured. In per protocol analysis mean striae depth was decreased by 21.64%, observed at 6 months follow-up with the combined approach, compared to an increase of 1.73% in the control group (P radiofrequency, combined with bipolar radiofrequency potentiated by infrared light, is an effective treatment of both immature and mature striae of the abdomen. © 2016 Wiley Periodicals, Inc.

Dialectical behavior therapy for adolescents with bipolar disorder: results from a pilot randomized trial.

Science.gov (United States)

Goldstein, Tina R; Fersch-Podrat, Rachael K; Rivera, Maribel; Axelson, David A; Merranko, John; Yu, Haifeng; Brent, David A; Birmaher, Boris

2015-03-01

The purpose of this study was to conduct a pilot randomized trial of dialectical behavior therapy (DBT) versus psychosocial treatment as usual (TAU) for adolescents diagnosed with bipolar disorder (BP). We recruited participants 12-18 years of age with a primary BP diagnosis (I, II, or operationalized not otherwise specified [NOS] criteria) from a pediatric specialty clinic. Eligible patients were assigned using a 2:1 randomization structure to either DBT (n=14) or psychosocial TAU (n=6). All patients received medication management from a study-affiliated psychiatrist. DBT included 36 sessions (18 individual, 18 family skills training) over 1 year. TAU was an eclectic psychotherapy approach consisting of psychoeducational, supportive, and cognitive behavioral techniques. An independent evaluator, blind to treatment condition, assessed outcomes including affective symptoms, suicidal ideation and behavior, nonsuicidal self-injurious behavior, and emotional dysregulation, quarterly over 1 year. Adolescents receiving DBT attended significantly more therapy sessions over 1 year than did adolescents receiving TAU, possibly reflecting greater engagement and retention; both treatments were rated as highly acceptable by adolescents and parents. As compared with adolescents receiving TAU, adolescents receiving DBT demonstrated significantly less severe depressive symptoms over follow-up, and were nearly three times more likely to demonstrate improvement in suicidal ideation. Models indicate a large effect size, for more weeks being euthymic, over follow-up among adolescents receiving DBT. Although there were no between-group differences in manic symptoms or emotional dysregulation with treatment, adolescents receiving DBT, but not those receiving TAU, evidenced improvement from pre- to posttreatment in both manic symptoms and emotional dysregulation. DBT may offer promise as an adjunct to pharmacotherapy in the treatment of depressive symptoms and suicidal ideation for

The Physiotherapy for Femoroacetabular Impingement Rehabilitation STudy (physioFIRST): A Pilot Randomized Controlled Trial.

Science.gov (United States)

Kemp, Joanne L; Coburn, Sally L; Jones, Denise M; Crossley, Kay M

2018-04-01

Study Design A pilot double-blind randomized controlled trial (RCT). Background The effectiveness of physical therapy for femoroacetabular impingement syndrome (FAIS) is unknown. Objectives To determine the feasibility of an RCT investigating the effectiveness of a physical therapy intervention for FAIS. Methods Participants were 17 women and 7 men (mean ± SD age, 37 ± 8 years; body mass index, 25.4 ± 3.4 kg/m 2 ) with FAIS who received physical therapy interventions provided over 12 weeks. The FAIS-specific physical therapy group received personalized progressive strengthening and functional retraining. The control group received standardized stretching exercises. In addition, both groups received manual therapy, progressive physical activity, and education. The primary outcome was feasibility, including integrity of the protocol, recruitment and retention, outcome measures, randomization procedure, and sample-size estimate. Secondary outcomes included hip pain and function (international Hip Outcome Tool-33 [iHOT-33]) and hip muscle strength. Poststudy interviews were conducted to determine potential improvements for future studies. Results Twenty-four (100%) patients with known eligibility agreed to participate. Four patients (17%) were lost to follow-up. All participants and the tester remained blinded, and the control intervention was acceptable to participants. The between-group mean differences in change scores were 16 (95% confidence interval [CI]: -9, 38) for the iHOT-33 and 0.24 (95% CI: 0.02, 0.47) Nm/kg for hip adduction strength, favoring the FAIS-specific physical therapy group. Using an effect size of 0.61, between-group improvements for the iHOT-33 suggest that 144 participants are required for a full-scale RCT. Conclusion A full-scale RCT of physical therapy for FAIS is feasible. A FAIS-specific physical therapy program has the potential for a moderate to large positive effect on hip pain, function, and hip adductor strength. Level of Evidence

Wean earlier and automatically with new technology (the WEAN study). A multicenter, pilot randomized controlled trial.

Science.gov (United States)

Burns, Karen E A; Meade, Maureen O; Lessard, Martin R; Hand, Lori; Zhou, Qi; Keenan, Sean P; Lellouche, Francois

2013-06-01

Automated weaning has not been compared with a paper-based weaning protocol in North America. We conducted a pilot randomized trial comparing automated weaning with protocolized weaning in critically ill adults to evaluate clinician compliance and acceptance of the weaning and sedation protocols, recruitment, and impact on outcomes. From August 2007 to October 2009, we enrolled critically ill adults requiring more than 24 hours of mechanical ventilation and at least partial reversal of the condition precipitating respiratory failure at nine Canadian intensive care units. We randomized patients who tolerated at least 30 minutes of pressure support and either failed or were not yet ready to undergo a spontaneous breathing trial to automated or protocolized weaning. Both groups used pressure support, included spontaneous breathing trials, used a common positive end-expiratory pressure-FI(O(2)) chart, sedation protocol, and criteria for extubation, reintubation, and noninvasive ventilation. We recruited 92 patients (49 automated, 43 protocolized) over 26 months. Adherence to assigned weaning protocols and extreme sedation scale scores fell within prespecified thresholds. Combined physician-respiratory therapist and nurse acceptance scores of the study weaning and sedation protocols, respectively, were not significantly different. Automated weaning patients had significantly shorter median times to first successful spontaneous breathing trial (1.0 vs. 4.0 d; P 4.0 d; P = 0.02), and successful extubation (4.0 vs. 5.0 d; P = 0.01), and underwent fewer tracheostomies and episodes of protracted ventilation. Compared with a standardized protocol, automated weaning was associated with promising outcomes that warrant further investigation. Minor protocol modifications may increase compliance, facilitate recruitment, and enhance feasibility. Clinical trial registered with www.controlled-trials.com (ISRCTN43760151).

A Youth-Led, Social Marketing Intervention Run by Adolescents to Encourage Healthy Lifestyles among Younger School Peers (EYTO-Kids Project): A Protocol for Pilot Cluster Randomized Controlled Trial (Spain)

OpenAIRE

Tarro, Lucia; Aceves-Martins, Magaly; Papell-Garcia, Ignasi; Arola, Llu?s; Giralt, Montse; Llaurad?, Elisabet; Sol?, Rosa

2017-01-01

Introduction: The EYTO-kids (European Youth Tackling Obesity in Adolescents and Children) study aims to increase fruit and/or vegetable consumption and physical activity, decrease sedentary lifestyles, and reduce the intake of sugary drinks and fast food using an innovative methodology based on social marketing and youth involvement. Methods: This study is a pilot school-based cluster randomized controlled 10-month intervention spanning two academic years (2015?2016 and 2016?2017), with eight...

The Preliminary Effects of Massage and Inhalation Aromatherapy on Chemotherapy-Induced Acute Nausea and Vomiting: A Quasi-Randomized Controlled Pilot Trial.

Science.gov (United States)

Zorba, Pinar; Ozdemir, Leyla

2017-04-20

Despite pharmacological treatment, chemotherapy-induced nausea and vomiting (CINV) are observed in patients. This quasi-randomized controlled pilot study evaluated the feasibility and preliminary effects of massage and inhalation aromatherapies on chemotherapy-induced acute nausea/vomiting. Seventy-five patients with breast cancer were randomly grouped into 1 of 3 groups: massage (n = 25), inhalation (n = 25), and control (n = 25). The patients in the massage group received 20-minute aromatherapy foot massage, whereas those in the inhalation group received 3-minute inhalation aromatherapy before their second, third, and fourth chemotherapy cycles. The control group underwent only the routine treatment. A nausea, vomiting, and retching patient follow-up form was used to evaluate nausea severity by visual analog scale and frequency of vomiting and retching. The incidence of nausea and retching was significantly higher in the control group than in the other groups in the third and fourth chemotherapy cycles (P aromatherapy groups than in the control group. Nausea and retching incidence was reduced in the aromatherapy groups compared with that in the control group. Nonpharmacological approaches are recommended for managing CINV. Massage and inhalation aromatherapy seems promising regarding the management of CINV.

Impact of sleep deprivation on anaesthesia residents' non-technical skills: a pilot simulation-based prospective randomized trial.

Science.gov (United States)

Neuschwander, A; Job, A; Younes, A; Mignon, A; Delgoulet, C; Cabon, P; Mantz, J; Tesniere, A

2017-07-01

Sleep deprivation is common in anaesthesia residents, but its impact on performance remains uncertain. Non-technical skills (team working, situation awareness, decision making, and task management) are key components of quality of care in anaesthesia, particularly in crisis situations occurring in the operating room. The impact of sleep deprivation on non-technical skills is unknown. We tested the hypothesis that in anaesthesia residents sleep deprivation is associated with impaired non-technical skills. Twenty anaesthesia residents were randomly allocated to undergo a simulation session after a night shift [sleep-deprived (SLD) group, n =10] or after a night of rest [rested (R) group, n =10] from January to March 2015. The simulated scenario was a situation of crisis management in the operating room. The primary end point was a composite score of anaesthetists' non-technical skills (ANTS) assessed by two blinded evaluators. Non-technical skills were significantly impaired in the SLD group [ANTS score 12.2 (interquartile range 10.5-13)] compared with the R group [14.5 (14-15), P technical skills of anaesthesia residents in a simulated anaesthesia intraoperative crisis scenario. NCT02622217. © The Author 2017. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Comparison of intravenous versus topical tranexamic acid in total knee arthroplasty: a prospective randomized study.

Science.gov (United States)

Patel, Jay N; Spanyer, Jonathon M; Smith, Langan S; Huang, Jiapeng; Yakkanti, Madhusudhan R; Malkani, Arthur L

2014-08-01

The purpose of this study was to compare the efficacy of topical Tranexamic Acid (TXA) versus Intravenous (IV) Tranexamic Acid for reduction of blood loss following primary total knee arthroplasty (TKA). This prospective randomized study involved 89 patients comparing topical administration of 2.0g TXA, versus IV administration of 10mg/kg. There were no differences between the two groups with regard to patient demographics or perioperative function. The primary outcome measure, perioperative change in hemoglobin level, showed a decrease of 3.06 ± 1.02 in the IV group and 3.42 ± 1.07 in the topical group (P = 0.108). There were no statistical differences between the groups in preoperative hemoglobin level, lowest postoperative hemoglobin level, or total drain output. One patient in the topical group required blood transfusion (P = 0.342). Based on our study, topical Tranexamic Acid has similar efficacy to IV Tranexamic Acid for TKA patients. Copyright © 2014 Elsevier Inc. All rights reserved.

TVT and TVT-O for surgical treatment of primary stress urinary incontinence: prospective randomized trial.

Science.gov (United States)

Krofta, Ladislav; Feyereisl, Jaroslav; Otcenásek, Michal; Velebil, Petr; Kasíková, Eva; Krcmár, Michal

2010-02-01

A study was conducted to compare the efficacy and complications of TVT and TVT-O. This study is a prospective randomized trial involving 300 women with primary SUI; 149 received TVT, and 151 patients were treated with TVT-O. At the 1 year follow-up, 141 TVT patients and 147 TVT-O patients (dropout, 5.3% and 2.6%) were evaluated using urodynamic studies, validated questionnaires, and a 1-h pad test. The mean operating time was shorter in the TVT-O group (p 0.05). Inner thigh discomfort was reported by 5.4% of TVT-O patients. In the TVT and the TVT-O groups, respectively, 90.1% and 88.4% women were objectively cured. The satisfaction with the surgical outcome reflects the significant decrease in the questionnaire mean symptom scores in both groups. Postoperative de novo urgency was significantly more common in the TVT-O patients (p = 0.015). The groups showed comparable objective and subjective cure rates.

Effect of raw milk on lactose intolerance: a randomized controlled pilot study.

Science.gov (United States)

Mummah, Sarah; Oelrich, Beibei; Hope, Jessica; Vu, Quyen; Gardner, Christopher D

2014-01-01

This pilot study aimed to determine whether raw milk reduces lactose malabsorption and/or lactose intolerance symptoms relative to pasteurized milk. We performed a crossover trial involving 16 adults with self-reported lactose intolerance and lactose malabsorption confirmed by hydrogen (H2) breath testing. Participants underwent 3, 8-day milk phases (raw vs 2 controls: pasteurized, soy) in randomized order separated by 1-week washout periods. On days 1 and 8 of each phase, milk consumption was 473 mL (16 oz); on days 2 to 7, milk dosage increased daily by 118 mL (4 oz), beginning with 118 mL (4 oz) on day 2 and reaching 710 mL (24 oz) on day 7. Outcomes were area under the breath H2 curve (AUC H2) and self-reported symptom severity (visual analog scales: flatulence/gas, audible bowel sounds, abdominal cramping, diarrhea). AUC H2 (mean ± standard error of the mean) was higher for raw vs pasteurized on day 1 (113 ± 21 vs 71 ± 12 ppm·min·10(-2), respectively, P = .01) but not day 8 (72 ± 14 vs 74 ± 15 ppm·min·10(-2), respectively, P = .9). Symptom severities were not different for raw vs pasteurized on day 7 with the highest dosage (P >.7). AUC H2 and symptom severities were higher for both dairy milks compared with soy milk. Raw milk failed to reduce lactose malabsorption or lactose intolerance symptoms compared with pasteurized milk among adults positive for lactose malabsorption. These results do not support widespread anecdotal claims that raw milk reduces the symptoms of lactose intolerance.

Improving Sleep for Hospitalized Antepartum Patients: A Non-Randomized Controlled Pilot Study.

Science.gov (United States)

Lee, Kathryn A; Gay, Caryl L

2017-12-15

To evaluate feasibility and efficacy of a hospital-based protocol for improving sleep in high- risk antepartum patients. Sleep measures were compared during 1 week of hospitalization before and after implementing a Sleep Improvement Protocol for Antepartum Patients (SIP-AP). A non-randomized convenience sample of usual care controls was compared to a subsequent intervention sample after the protocol was implemented. Women were eligible if they spoke English, were medically stable, pregnant for at least 20 weeks, and hospitalized at least 24 hours; 25 pregnant women had sufficient data for analyses (11 controls, 14 intervention). Sleep was assessed in 3 ways: the Pittsburgh Sleep Quality Index was completed after obtaining consent to estimate sleep quality prior to hospital admission; sleep diary completed each hospital day; and General Sleep Disturbance Scale completed at 7 days or prior to hospital discharge. Symptoms that could affect sleep were assessed with the Memorial Symptom Assessment Scale. Both groups recorded similar sleep duration (7 hours) but the intervention group had fewer symptoms and significantly ( P = .015) lower sleep disturbance scores (53.1 ± 14.5) than controls (71.9 ± 18.8). Participant feedback about the intervention was positive, although adherence to components of the intervention protocol was variable. This pilot study provides evidence of the feasibility and preliminary efficacy of the SIP-AP intervention for reducing symptoms and improving sleep of antepartum patients during hospitalization. Further detailed evaluation of specific components of this protocol is warranted, and other types of hospitalized patients may benefit from unit-based modifications to this SIP-AP protocol. © 2017 American Academy of Sleep Medicine

Radiotherapy for calcaneodynia. Results of a single center prospective randomized dose optimization trial

Energy Technology Data Exchange (ETDEWEB)

Ott, O.J.; Jeremias, C.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R. [University Hospital Erlangen (Germany). Dept. of Radiation Oncology

2013-04-15

The aim of this work was to compare the efficacy of two different dose fractionation schedules for radiotherapy of patients with calcaneodynia. Between February 2006 and April 2010, 457 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received radiotherapy using the orthovoltage technique. One radiotherapy series consisted of 6 single fractions/3 weeks. In case of insufficient remission of pain after 6 weeks a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. Endpoint was pain reduction. Pain was measured before, immediately after, and 6 weeks after radiotherapy using a visual analogue scale (VAS) and a comprehensive pain score (CPS). The overall response rate for all patients was 87 % directly after and 88 % 6 weeks after radiotherapy. The mean VAS values before, immediately after, and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 65.5 {+-} 22.1 and 64.0 {+-} 20.5 (p = 0.188), 34.8 {+-} 24.7 and 39.0 {+-} 26.3 (p = 0.122), and 25.1 {+-} 26.8 and 28.9 {+-} 26.8 (p = 0.156), respectively. The mean CPS before, immediately after, and 6 weeks after treatment was 10.1 {+-} 2.7 and 10.0 {+-} 3.0 (p = 0.783), 5.6 {+-} 3.7 and 6.0 {+-} 3.9 (p = 0.336), 4.0 {+-} 4.1 and 4.3 {+-} 3.6 (p = 0.257), respectively. No statistically significant differences between the two single dose trial arms for early (p = 0.216) and delayed response (p = 0.080) were found. Radiotherapy is an effective treatment option for the management of calcaneodynia. For radiation protection reasons, the dose for a radiotherapy series is recommended not to exceed 3-6 Gy. (orig.)

Effects of periodontal treatment on lung function and exacerbation frequency in patients with chronic obstructive pulmonary disease and chronic periodontitis: a 2-year pilot randomized controlled trial.

Science.gov (United States)

Zhou, Xuan; Han, Jing; Liu, Zhiqiang; Song, Yiqing; Wang, Zuomin; Sun, Zheng

2014-06-01

To evaluate the direct effects of periodontal therapy in Chronic Obstructive Pulmonary Disease (COPD) patients with chronic periodontitis (CP). In a pilot randomized controlled trial, 60 COPD patients with CP were randomly assigned to receive scaling and root planing (SRP) treatment, supragingival scaling treatment, or oral hygiene instructions only with no periodontal treatment. We evaluated their periodontal indexes, respiratory function, and COPD exacerbations at baseline, 6 months, 1, and 2 years. Compared with the control group, measurements of periodontal indexes were significantly improved in patients in two treatment groups at 6-month, 1-year, and 2-year follow-up (all p periodontal therapy in COPD patients with CP may improve lung function and decrease the frequency of COPD exacerbation. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Sugammadex versus neostigmine in pediatric patients: a prospective randomized study

Directory of Open Access Journals (Sweden)

Turhan Kara

2014-12-01

Full Text Available Background and objectives: Acetylcholinesterase inhibitors may cause postoperative residual curarization when they are used for reversal of neuromuscular blockade. Sugammadex reverses neuromuscular blockade by chemical encapsulation and is not associated with the side effects that may occur with the use of anticholinesterase agents. Because of increased outpatient surgical procedures postoperative residual curarization and rapid postoperative recovery have a greater importance in the pediatric patient population. The aim of this study was to compare the efficacy of sugammadex and neostigmine on reversing neuromuscular blockade in pediatric patients undergoing outpatient surgical procedures. Methods: 80 patients, aged 2-12 years, scheduled for outpatient surgery were enrolled in this randomized prospective study. Neuromuscular blockade was achieved with 0.6 mgkg−1 rocuronium and monitorized with train-of-four. Group RN (n = 40 received 0.03 mgkg−1 neostigmine, Group RS (n = 40 received 2 mgkg−1 sugammadex for reversal of rocuronium. Extubation time (time from the reversal of neuromuscular blockade to extubation, train-of-four ratio during this time, time to reach train-of-four > 0.9, and probable complications were recorded. Results: There was no significant difference between the patients' characteristics. Extubation time and time to reach train-of-four > 0.9 were significantly higher in Group RN (p = 0.001, p = 0.002. Train-of-four at the time of neostigmine/sugammadex injection in Group RN were significantly higher than in the RS group (p = 0.020. Extubation train-of-four ratio was significantly lower in Group RN (p = 0.002. Conclusion: Sugammadex provides safer extubation with a shorter recovery time than neostigmine in pediatric patients undergoing outpatient surgical procedures.

Prospective randomized trial to assess effects of continuing hormone therapy on cerebral function in postmenopausal women at risk for dementia.

Directory of Open Access Journals (Sweden)

Natalie L Rasgon

Full Text Available The objective of this study was to examine the effects of estrogen-based hormone therapy (HT on regional cerebral metabolism in postmenopausal women (mean age = 58, SD = 5 at risk for development of dementia. The prospective clinical trial design included pre- and post-intervention neuroimaging of women randomized to continue (HT+ or discontinue (HT- therapy following an average of 10 years of use. The primary outcome measure was change in brain metabolism during the subsequent two years, as assessed with fluorodeoxyglucose-18 positron emission tomography (FDG-PET. Longitudinal FDG-PET data were available for 45 study completers. Results showed that women randomized to continue HT experienced relative preservation of frontal and parietal cortical metabolism, compared with women randomized to discontinue HT. Women who discontinued 17-β estradiol (17βE-based HT, as well as women who continued conjugated equine estrogen (CEE-based HT, exhibited significant decline in metabolism of the precuneus/posterior cingulate cortical (PCC area. Significant decline in PCC metabolism was additionally seen in women taking concurrent progestins (with either 17βE or CEE. Together, these findings suggest that among postmenopausal subjects at risk for developing dementia, regional cerebral cortical metabolism is relatively preserved for at least two years in women randomized to continue HT, compared with women randomized to discontinue HT. In addition, continuing unopposed 17βE therapy is associated specifically with preservation of metabolism in PCC, known to undergo the most significant decline in the earliest stages of Alzheimer's disease.ClinicalTrials.gov NCT00097058.

Healing the heart: a randomized pilot study of a spiritual retreat for depression in acute coronary syndrome patients.

Science.gov (United States)

Warber, Sara L; Ingerman, Sandra; Moura, Vera L; Wunder, Jenna; Northrop, Alyssa; Gillespie, Brenda W; Durda, Kate; Smith, Katherine; Rhodes, Katherine S; Rubenfire, Melvyn

2011-01-01

Depression is associated with increased risk of cardiovascular morbidity and mortality in coronary heart disease. Numerous conventional and complementary therapies may address depression. Few involving spirituality have been tested. The aim of this study was to compare the effects of a nondenominational spiritual retreat, Medicine for the Earth (MFTE), on depression and other measures of well-being six- to 18-months post acute coronary syndrome (ACS). A randomized controlled pilot study of MFTE, Lifestyle Change Program (LCP), or usual cardiac care (control) was conducted in Southeastern Michigan. ACS patients were recruited via local and national advertising (n = 58 enrolled, 41 completed). The four-day MFTE intervention included guided imagery, meditation, drumming, journal writing, and nature-based activities. The four-day LCP included nutrition education, exercise, and stress management. Both retreat groups received follow-up phone coaching biweekly for three months. Validated self-report scales of depression, spiritual well-being, perceived stress, and hope were collected at baseline, immediately post-retreat, and at three and six months. Depression was not significantly different among groups (P = .21). However, the MFTE group had the highest depression scores at baseline and had significantly lower scores at all postintervention time points (P ≤ .002). Hope significantly improved among MFTE participants, an effect that persisted at three- and six-month follow-up (P = .014). Although several measures showed improvement in all groups by six months, the MFTE group had immediate improvement post-retreat, which was maintained. This pilot study shows that a nondenominational spiritual retreat, MFTE, can be used to increase hope while reducing depression in patients with ACS. Copyright © 2011 Elsevier Inc. All rights reserved.

Phase II prospective randomized trial of weight loss prior to radical prostatectomy.

Science.gov (United States)

Henning, Susanne M; Galet, Colette; Gollapudi, Kiran; Byrd, Joshua B; Liang, Pei; Li, Zhaoping; Grogan, Tristan; Elashoff, David; Magyar, Clara E; Said, Jonathan; Cohen, Pinchas; Aronson, William J

2017-12-04

Obesity is associated with poorly differentiated and advanced prostate cancer and increased mortality. In preclinical models, caloric restriction delays prostate cancer progression and prolongs survival. We sought to determine if weight loss (WL) in men with prostate cancer prior to radical prostatectomy affects tumor apoptosis and proliferation, and if WL effects other metabolic biomarkers. In this Phase II prospective trial, overweight and obese men scheduled for radical prostatectomy were randomized to a 5-8 week WL program consisting of standard structured energy-restricted meal plans (1200-1500 Kcal/day) and physical activity or to a control group. The primary endpoint was apoptotic index in the radical prostatectomy malignant epithelium. Secondary endpoints were proliferation (Ki67) in the radical prostatectomy tissue, body weight, body mass index (BMI), waist to hip ratio, body composition, and serum PSA, insulin, triglyceride, cholesterol, testosterone, estradiol, leptin, adiponectin, interleukin 6, interleukin 8, insulin-like growth factor 1, and IGF binding protein 1. In total 23 patients were randomized to the WL intervention and 21 patients to the control group. Subjects in the intervention group had significantly more weight loss (WL:-3.7 ± 0.5 kg; Control:-1.6 ± 0.5 kg; p = 0.007) than the control group and total fat mass was significantly reduced (WL:-2.1 ± 0.4; Control: 0.1 ± 0.3; p = 0.015). There was no significant difference in apoptotic or proliferation index between the groups. Among the other biomarkers, triglyceride, and insulin levels were significantly decreased in the WL compared with the control group. In summary, this short-term WL program prior to radical prostatectomy resulted in significantly more WL in the intervention vs. the control group and was accompanied by significant reductions in body fat mass, circulating triglycerides, and insulin. However, no significant changes were observed in malignant

A Two-Year Randomized Trial of Interventions to Decrease Stress Hormone Vasopressin Production in Patients with Meniere's Disease-A Pilot Study.

Science.gov (United States)

Kitahara, Tadashi; Okamoto, Hidehiko; Fukushima, Munehisa; Sakagami, Masaharu; Ito, Taeko; Yamashita, Akinori; Ota, Ichiro; Yamanaka, Toshiaki

2016-01-01

Meniere's disease, a common inner ear condition, has an incidence of 15-50 per 100,000. Because mental/physical stress and subsequent increase in the stress hormone vasopressin supposedly trigger Meniere's disease, we set a pilot study to seek new therapeutic interventions, namely management of vasopressin secretion, to treat this disease. We enrolled 297 definite Meniere's patients from 2010 to 2012 in a randomized-controlled and open-label trial, assigning Group-I (control) traditional oral medication, Group-II abundant water intake, Group-III tympanic ventilation tubes and Group-IV sleeping in darkness. Two hundred sixty-three patients completed the planned 2-year-follow-up, which included assessment of vertigo, hearing, plasma vasopressin concentrations and changes in stress/psychological factors. At 2 years, vertigo was completely controlled in 54.3% of patients in Group-I, 81.4% in Group-II, 84.1% in Group-III, and 80.0% in Group-IV (statistically I management for Meniere's disease. However, avoidance of stress is unrealistic for patients who live in demanding social environments. Our findings in this pilot study suggest that interventions to decrease vasopressin secretion by abundant water intake, tympanic ventilation tubes and sleeping in darkness is feasible in treating Meniere's disease, even though these therapies did not alter reported mental/physical stress levels. ClinicalTrials.gov NCT01099046.

Prospective, Randomized, Multi-centered Clinical Trial Assessing Safety and Efficacy of a Synthetic Cartilage Implant Versus First Metatarsophalangeal Arthrodesis in Advanced Hallux Rigidus.

Science.gov (United States)

Baumhauer, Judith F; Singh, Dishan; Glazebrook, Mark; Blundell, Chris; De Vries, Gwyneth; Le, Ian L D; Nielsen, Dominic; Pedersen, M Elizabeth; Sakellariou, Anthony; Solan, Matthew; Wansbrough, Guy; Younger, Alastair S E; Daniels, Timothy

2016-05-01

Although a variety of great toe implants have been tried in an attempt to maintain toe motion, the majority have failed with loosening, malalignment/dislocation, implant fragmentation and bone loss. In these cases, salvage to arthrodesis is more complicated and results in shortening of the ray or requires structural bone graft to reestablish length. This prospective study compared the efficacy and safety of this small (8/10 mm) hydrogel implant to the gold standard of a great toe arthrodesis for advanced-stage hallux rigidus. In this prospective, randomized non-inferiority study, patients from 12 centers in Canada and the United Kingdom were randomized (2:1) to a synthetic cartilage implant or first metatarsophalangeal (MTP) joint arthrodesis. VAS pain scale, validated outcome measures (Foot and Ankle Ability Measure [FAAM] sport scale), great toe active dorsiflexion motion, secondary procedures, radiographic assessment, and safety parameters were evaluated. Analysis was performed using intent-to-treat (ITT) and modified ITT (mITT) methodology. The primary endpoint for the study consisted of a single composite endpoint using the 3 primary study outcomes (pain, function, and safety). The individual subject's outcome was considered a success if all of the following criteria were met: (1) improvement (decrease) from baseline in VAS pain of ≥30% at 12 months; (2) maintenance of function from baseline in FAAM sports subscore at 12 months; and (3) absence of major safety events at 2 years. The proportion of successes in each group was determined and 1-sided 95% confidence interval for the difference between treatment groups was calculated. Noninferiority of the implant to arthrodesis was considered statistically significant if the 1-sided 95% lower confidence interval was greater than the equivalence limit (sports and activity of daily living subscores improved significantly at 12 and 24 months in both groups. First MTP active dorsiflexion motion improvement was 6

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

Science.gov (United States)

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

2013-01-01

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

Metronomic therapy with oral 6-mercaptopurine in elderly acute myeloid leukemia: A prospective pilot study

Directory of Open Access Journals (Sweden)

Akhil Kapoor

2016-01-01

Full Text Available Introduction: Acute myeloid leukemia (AML in elderly patients differs biologically from that in younger patients and is known to have unfavorable chromosomal rearrangements, higher resistance, and lower tolerance to chemotherapy. In such circumstances, instead of giving full-blown chemotherapy, palliative metronomic chemotherapy (MCT could be a treatment option. Patients and Methods: We performed a prospective pilot study of old AML patients (age >60 years not amenable to curative treatment. Thirty-two patients were enrolled into the study and were treated with daily oral 6-mercaptopurine 75 mg/m 2 . The following inclusion criteria were used: age >60 years, nonpromyelocytic AML, the absence of uncontrolled comorbidities, and patient not amenable to curative treatment. Overall survival (OS was calculated using Kaplan-Meier method and Cox regression analysis were used to calculate the hazards ratio of significant factors. Results: The median age of the patients was 69 years (range: 61-86 years with male: female ratio of 2.5:1. About 59.4% of patients had Eastern Cooperative Oncology Group performance status of 2 while rest had the status of 3. The median OS was 6 months (95% confidence interval [CI]: 4.4-7.6. Males had median OS of 7 months (95% CI: 5.4-8.6 versus females with OS of 3 months (95% CI: 1.5-4.4; P = 0.008. There was no survival difference on the basis of baseline hemoglobin or French-American-British class. There were no Grade 4 toxicities and no episode of febrile neutropenia. Conclusions: MCT with oral 6-mercaptopurine is an attractive treatment option in elderly AML patients who are not amenable to curative therapy with minimal toxicities.

Rehab-let: touchscreen tablet for self-training impaired dexterity post stroke: study protocol for a pilot randomized controlled trial.

Science.gov (United States)

Rand, Debbie; Zeilig, Gabi; Kizony, Rachel

2015-06-18

Impaired dexterity of the weaker upper extremity is common post stroke and it is recommended that these individuals practice many repetitions of movement to regain function. However, stroke rehabilitation methods do not achieve the required intensity to be effective. Touchscreen tablet technology may be used as a motivating tool for self-training impaired dexterity of the weaker upper extremity post stroke. Rehab-let is a self-training protocol utilizing game apps on a touchscreen for practicing movement of the weaker upper extremity. We will conduct a pilot randomized controlled trial to assess Rehab-let compared to traditional self-training to improve dexterity of the weaker hand, and to increase self-training time and satisfaction in individuals with subacute stroke. Forty individuals with stroke undergoing subacute rehabilitation will be randomly allocated to Rehab-let or a traditional self-training program using therapeutic aids such as balls, blocks and pegs. All participants will be requested to perform self-training for 60 minutes a day, 5 times a week for 4 weeks. Dexterity assessed by The Nine Hole Peg Test is the main outcome measure. Assessments will be administered pre and post the self-training intervention by assessors blind to the group allocation. The outcomes of this study will inform the design of a fully powered randomized controlled trial to evaluate the effectiveness of Rehab-let. If found to be effective, Rehab-let can be used during subacute rehabilitation to increase treatment intensity and improve dexterity. Potentially, Rehab-let can also be used after discharge and might be ideal for individuals with mild stroke who are often not referred to formal rehabilitation. Current Controlled Trials NCT02136433 registered on 17 September 2014.

Nurse-delivered counselling intervention for parental HIV disclosure: results from a pilot randomized controlled trial in China.

Science.gov (United States)

Simoni, Jane M; Yang, Joyce P; Shiu, Cheng-Shi; Chen, Wei-Ti; Udell, Wadiya; Bao, Meijuan; Zhang, Lin; Lu, Hongzhou

2015-06-01

The objective of this study was to design and conduct a preliminary evaluation of an intervention to assist parents in decision-making about disclosure of their HIV diagnosis to their children. This was a pilot randomized controlled trial (RCT) with blinded assessment. Participants were randomized to intervention or treatment-as-usual (TAU) arms. The study occurred at an outpatient HIV primary care centre in Shanghai, China. Participants were 20 HIV-positive outpatients with at least one child (13-25 years old) who was unaware of the parent's HIV diagnosis. The nurse-delivered intervention involved three, hour-long, individual sessions over 4 weeks. Intervention content comprised family assessment, discussion of advantages and disadvantages of disclosure, psycho-education about cognitive, social and emotional abilities of children at different developmental stages, and disclosure planning and practicing via role-plays. Primary study outcomes for intervention versus TAU arms were self-reported disclosure distress, self-efficacy, and behaviours along a continuum from no disclosure to full disclosure and open communication about HIV. In all cross-sectional (Wald tests) and longitudinal (general estimating equations) analyses, at both postintervention (4 weeks) and follow-up (13 weeks), effects were in the hypothesized directions. Despite the small sample size, most of these between-arm comparisons were statistically significant, with at least one result for each outcome indicating a 'large' effect size. Our results suggest that nurses are able to deliver a counselling intervention in a clinic setting with the potential to alleviate parental distress around HIV disclosure to their children. Findings warrant future trials powered for efficacy.

Controller adherence following hospital discharge in high risk children: A pilot randomized trial of text message reminders.

Science.gov (United States)

Kenyon, Chén C; Gruschow, Siobhan M; Quarshie, William O; Griffis, Heather; Leach, Michelle C; Zorc, Joseph J; Bryant-Stephens, Tyra C; Miller, Victoria A; Feudtner, Chris

2018-02-13

To assess the feasibility of a mobile health, inhaled corticosteroid (ICS) adherence reminder intervention and to characterize adherence trajectories immediately following severe asthma exacerbation in high-risk urban children with persistent asthma. Children aged 2-13 with persistent asthma were enrolled in this pilot randomized controlled trial during an asthma emergency department (ED) visit or hospitalization. Intervention arm participants received daily text message reminders for 30 days, and both arms received electronic sensors to measure ICS use. Primary outcomes were feasibility of sensor use and text message acceptability. Secondary outcomes included adherence to prescribed ICS regimen and 30-day adherence trajectories. Group-based trajectory modeling was used to examine adherence trajectories. Forty-one participants (mean age 5.9) were randomized to intervention (n = 21) or control (n = 20). Overall, 85% were Black, 88% had public insurance, and 51% of the caregivers had a high school education or less. Thirty-two participant families (78%) transmitted medication adherence data; of caregivers who completed the acceptability survey, 25 (96%) chose to receive daily reminders beyond that study interval. Secondary outcome analyses demonstrated similar average daily adherence between groups (intervention = 36%; control = 32%, P = 0.73). Three adherence trajectories were identified with none ever exceeding 80% adherence. Within a high-risk pediatric cohort, electronic monitoring of ICS use and adherence reminders delivered via text message were feasible for most participants, but there was no signal of effect. Adherence trajectories following severe exacerbation were suboptimal, demonstrating an important opportunity for asthma care improvement.

Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence: Study Protocol of a Pilot Multicentered, Randomized, Parallel, Sham-Controlled Trial

Directory of Open Access Journals (Sweden)

Seungwon Shin

2016-01-01

Full Text Available This pilot multicentered, randomized, parallel, sham-controlled trial is intended to evaluate the effectiveness and safety of electroacupuncture therapy for poststroke patients with urinary incontinence. Forty stroke survivors aged >19 years will be recruited in 2 hospitals in the Republic of Korea. Patients who experienced stroke within 2 years and satisfy criteria of urinary frequencies ≥2 with either 3 to 4 points on the Patient Perception of Intensity of Urgency Scale or 13 points or more on the Korean version of the International Prostate Symptom Scale (K-IPSS will be identified, along with other eligibility criteria. Patients will be randomly allocated to either a treatment or control group to receive 10 sessions of electroacupuncture or sham therapies, respectively. Patients and outcome assessors will be blinded. The primary outcome is the change of Total Urgency and Frequency Score between the baseline and the trial endpoint. The K-IPSS, the International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form, and the Lower Urinary Tract Symptoms Outcome Score will be evaluated for effectiveness assessment. Adverse events will be reported after every session. The Blinding Index will also be calculated. Data will be statistically analyzed with 0.05 significance levels by 2-sided testing.

Effective therapy to reduce edema after total knee arthroplasty Multi-layer compression therapy or standard therapy with cool pack - a randomized controlled pilot trial

Science.gov (United States)

Stocker, Brigitta; Babendererde, Christine; Rohner-Spengler, Manuela; Müller, Urs W; Meichtry, André; Luomajoki, Hannu

2018-02-01

Background: After total knee arthroplasty (TKA) efficient control and reduction of postoperative edema is of great importance. Aim: The aim of this pilot study (EKNZ 2014 – 225 DRKS00006271) was to investigate the effectiveness of multi-layer compression therapy (MLCT) to reduce edema in the early period after surgery compared to the standard treatment with Cool Pack. Methods: In this randomized controlled pilot trial, sixteen patients after TKA were randomized into an intervention group (IG) or a control group (CG). Circumferential measurements were used to assess edema. Secondary outcomes were range of motion (ROM), pain (numeric rating scale, NRS) and function as measured with the fast Self Paced Walking Test (fSPWT). Results: Clinically relevant differences in edema reduction between the two groups were found in the early postoperative period and at the six weeks follow up. Six days postoperatively the group time interaction (IE) in favor of the IG were −3.8 cm (95 % CI: −5.1; −2.4) when measured 10 cm proximal to the joint space and −2.7 cm (CI: −4.1; −1.3) when measured 5 cm proximally. We further observed differences in secondary outcomes in favor of the CG. Six days postoperatively the IE for knee flexion was –8.3 ° (CI: −22.0; 5.4) and for the fSPWT it was 12.8 seconds (CI: −16.4; 41.3). Six weeks postoperatively these differences diminished. Conclusions: The findings suggest that MLCT could be an alternative treatment to reduce postoperative edema in patients after total knee arthroplasty. Eventually possible negative effects on early knee flexion and function must be considered.

The administration of intermittent parathyroid hormone affects functional recovery from trochanteric fractured neck of femur: a randomised prospective mixed method pilot study.

Science.gov (United States)

Chesser, T J S; Fox, R; Harding, K; Halliday, R; Barnfield, S; Willett, K; Lamb, S; Yau, C; Javaid, M K; Gray, A C; Young, J; Taylor, H; Shah, K; Greenwood, R

2016-06-01

We wished to assess the feasibility of a future randomised controlled trial of parathyroid hormone (PTH) supplements to aid healing of trochanteric fractures of the hip, by an open label prospective feasibility and pilot study with a nested qualitative sub study. This aimed to inform the design of a future powered study comparing the functional recovery after trochanteric hip fracture in patients undergoing standard care, versus those who undergo administration of subcutaneous injection of PTH for six weeks. We undertook a pilot study comparing the functional recovery after trochanteric hip fracture in patients 60 years or older, admitted with a trochanteric hip fracture, and potentially eligible to be randomised to either standard care or the administration of subcutaneous PTH for six weeks. Our desired outcomes were functional testing and measures to assess the feasibility and acceptability of the study. A total of 724 patients were screened, of whom 143 (20%) were eligible for recruitment. Of these, 123 were approached and 29 (4%) elected to take part. However, seven patients did not complete the study. Compliance with the injections was 11 out of 15 (73%) showing the intervention to be acceptable and feasible in this patient population. Only 4% of patients who met the inclusion criteria were both eligible and willing to consent to a study involving injections of PTH, so delivering this study on a large scale would carry challenges in recruitment and retention. Methodological and sample size planning would have to take this into account. PTH administration to patients to enhance fracture healing should still be considered experimental. Cite this article: Bone Joint J 2016;98-B:840-5. ©2016 Chesser et al.

Randomized and double-blinded pilot clinical study of the safety and anti-diabetic efficacy of the Rauvolfia-Citrus tea, as used in Nigerian Traditional Medicine

DEFF Research Database (Denmark)

Campbell-Tofte, Joan I A; Mølgaard, Per; Josefsen, Knud

2011-01-01

The aim of this randomized and double blinded pilot clinical trial was to investigate the anti-diabetic efficacy of the Rauvolfia-Citrus (RC) tea in humans. We have earlier shown that a combination of calorie-restriction and chronic administration of the RC tea to the genetic diabetic (BKS-db) mice...... resulted in the normalization of blood sugar, reduction in lipid accumulated in the mice eyes and prevention of the degeneration of the otherwise brittle BKS-db pancreas. The tea is made by boiling foliage of Rauvolfia vomitoria and fruits of Citrus aurantium and is used to treat diabetes in Nigerian folk...

Is Electrocautery of Patella Useful in Patella Non-Resurfacing Total Knee Arthroplasty?: A Prospective Randomized Controlled Study.

Science.gov (United States)

Kwon, Sae Kwang; Nguku, Levis; Han, Chang Dong; Koh, Yong-Gon; Kim, Dong-Wook; Park, Kwan Kyu

2015-12-01

There is controversy over the need for electrocauterization of the patella in non-resurfacing total knee arthroplasty (TKA). We investigated whether this procedure is beneficial through a prospective randomized controlled trial. Fifty patients who underwent electrocautery were compared with 50 patients who did not undergo this procedure. We determined cartilage status, preoperative and postoperative American Knee Society (AKS) score, the Western Ontario and McMaster Universities score (WOMAC) and the Patellofemoral (PF) scores for a minimum of 5 years. The two groups did not differ significantly in demographics, intraoperative cartilage status, or preoperative or postoperative outcomes. No complications were detected in either group. We found no benefits of electrocautery of the patella in patellar non-resurfacing TKA up to 5 years. Copyright © 2015 Elsevier Inc. All rights reserved.

Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur.

Science.gov (United States)

Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Etén-Bergqvist, Christina; Persson, Jan

2011-07-01

The aim of this prospective randomized multicenter study was to compare TVT (tension-free vaginal tape) with TVT-Secur in terms of efficacy and safety. We set out to enrol 280 stress incontinent women with a half time interim analysis of short-term cure and a continuous registration of adverse events. Of 133 randomized women, 126 were operated and 123 (TVT n = 62, TVT-Secur n = 61) available for 2 months follow-up. No significant differences were found between groups regarding demographics or grade of incontinence. At 2 months follow-up, subjective cure rate following TVT-Secur was significantly lower than for TVT (72% and 92%, respectively, p = 0.01). Three major complications occurred in the TVT-Secur group: tape erosion into the urethra, a tape inadvertently placed inside the bladder, and an immediate postoperative bleeding from the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding perioperative bleeding, hospital stay, urge symptoms, or postoperative urinary tract infections. Median time for surgery was 13 and 22 min for TVT-Secur and TVT, respectively (p TVT-Secur procedure had a significantly lower subjective cure rate than the retropubic TVT procedure. Due to this, in addition to three serious complications in the TVT-Secur group, we decided to stop further enrolment after the interim analysis. We discourage from further use of the TVT-Secur.

ENabling Reduction of Low-grade Inflammation in SEniors Pilot Study: Concept, Rationale, and Design.

Science.gov (United States)

Manini, Todd M; Anton, Stephen D; Beavers, Daniel P; Cauley, Jane A; Espeland, Mark A; Fielding, Roger A; Kritchevsky, Stephen B; Leeuwenburgh, Christiaan; Lewis, Kristina H; Liu, Christine; McDermott, Mary M; Miller, Michael E; Tracy, Russell P; Walston, Jeremy D; Radziszewska, Barbara; Lu, Jane; Stowe, Cindy; Wu, Samuel; Newman, Anne B; Ambrosius, Walter T; Pahor, Marco

2017-09-01

To test two interventions to reduce interleukin (IL)-6 levels, an indicator of low-grade chronic inflammation and an independent risk factor for impaired mobility and slow walking speed in older adults. The ENabling Reduction of low-Grade Inflammation in SEniors (ENRGISE) Pilot Study was a multicenter, double-blind, placebo-controlled randomized pilot trial of two interventions to reduce IL-6 levels. Five university-based research centers. Target enrollment was 300 men and women aged 70 and older with an average plasma IL-6 level between 2.5 and 30 pg/mL measured twice at least 1 week apart. Participants had low to moderate physical function, defined as self-reported difficulty walking one-quarter of a mile or climbing a flight of stairs and usual walk speed of less than 1 m/s on a 4-m usual-pace walk. Participants were randomized to losartan, omega-3 fish oil (ω-3), combined losartan and ω-3, or placebo. Randomization was stratified depending on eligibility for each group. A titration schedule was implemented to reach a dose that was safe and effective for IL-6 reduction. Maximal doses were 100 mg/d for losartan and 2.8 g/d for ω-3. IL-6, walking speed over 400 m, physical function (Short Physical Performance Battery), other inflammatory markers, safety, tolerability, frailty domains, and maximal leg strength were measured. Results from the ENRGISE Pilot Study will provide recruitment yields, feasibility, medication tolerance and adherence, and preliminary data to help justify a sample size for a more definitive randomized trial. The ENRGISE Pilot Study will inform a larger subsequent trial that is expected to have important clinical and public health implications for the growing population of older adults with low-grade chronic inflammation and mobility limitations. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

Pilot study evaluating a brief mindfulness intervention for those with chronic pain: study protocol for a randomized controlled trial.

Science.gov (United States)

Howarth, Ana; Perkins-Porras, Linda; Smith, Jared G; Subramaniam, Jeevakan; Copland, Claire; Hurley, Mike; Beith, Iain; Riaz, Muhammad; Ussher, Michael

2016-06-02

The burden of chronic pain is a major challenge, impacting the quality of life of patients. Intensive programmes of mindfulness-based therapy can help patients to cope with chronic pain but can be time consuming and require a trained specialist to implement. The self-management model of care is now integral to the care of patients with chronic pain; home-based interventions can be very acceptable, making a compelling argument for investigating brief, self-management interventions. The aim of this study is two-fold: to assess the immediate effects of a brief self-help mindfulness intervention for coping with chronic pain and to assess the feasibility of conducting a definitive randomized controlled trial to determine the effectiveness of such an intervention. A randomized controlled pilot study will be conducted to evaluate a brief mindfulness intervention for those with chronic pain. Ninety chronic pain patients who attend hospital outpatient clinics will be recruited and allocated randomly to either the control or treatment group on a 1:1 basis using the computer-generated list of random numbers. The treatment group receives mindfulness audios and the control group receives audios of readings from a non-fiction book, all of which are 15 minutes in length. Immediate effects of the intervention are assessed with brief psychological measures immediately before and after audio use. Mindfulness, mood, health-related quality of life, pain catastrophizing and experience of the intervention are assessed with standardized measures, brief ratings and brief telephone follow-ups, at baseline and after one week and one month. Feasibility is assessed by estimation of effect sizes for outcomes, patient adherence and experience, and appraisal of resource allocation in provision of the intervention. This trial will assess whether a brief mindfulness-based intervention is effective for immediately reducing perceived distress and pain with the side effect of increasing relaxation

Short-term intravenous antimicrobial prophylaxis for elective rectal cancer surgery: results of a prospective randomized non-inferiority trial.

Science.gov (United States)

Ishibashi, Keiichiro; Ishida, Hideyuki; Kuwabara, Kouki; Ohsawa, Tomonori; Okada, Norimichi; Yokoyama, Masaru; Kumamoto, Kensuke

2014-04-01

To investigate the non-inferiority of postoperative single-dose intravenous antimicrobial prophylaxis to multiple-dose intravenous antimicrobial prophylaxis in terms of the incidence of surgical site infections (SSIs) in patients undergoing elective rectal cancer surgery by a prospective randomized study. Patients undergoing elective surgery for rectal cancer were randomized to receive a single intravenous injection of flomoxef (group 1) or five additional doses (group 2) of flomoxef after the surgery. All the patients had received preoperative oral antibiotic prophylaxis (kanamycin and erythromycin) after mechanical cleansing within 24 h prior to surgery, and had received intravenous flomoxef during surgery. A total of 279 patients (including 139 patients in group 1 and 140 in group 2) were enrolled in the study. The incidence of SSIs was 13.7% in group 1 and 13.6% in group 2 (difference [95% confidence interval]: -0.2% [-0.9 to 0.7%]). The incidence of SSIs was not significantly different in patients undergoing elective rectal surgery who were treated using a single dose of postoperative antibiotics compared to those treated using multiple-dose antibiotics when preoperative mechanical and chemical bowel preparations were employed.

USE OF NEUROFEEDBACK AND MINDFULNESS TO ENHANCE RESPONSE TO HYPNOSIS TREATMENT IN INDIVIDUALS WITH MULTIPLE SCLEROSIS: Results From a Pilot Randomized Clinical Trial.

Science.gov (United States)

Jensen, Mark P; Battalio, Samuel L; Chan, Joy F; Edwards, Karlyn A; Day, Melissa A; Sherlin, Leslie H; Ehde, Dawn M

2018-01-01

This pilot study evaluated the possibility that 2 interventions hypothesized to increase slower brain oscillations (e.g., theta) may enhance the efficacy of hypnosis treatment, given evidence that hypnotic responding is associated with slower brain oscillations. Thirty-two individuals with multiple sclerosis and chronic pain, fatigue, or both, were randomly assigned to 1 of 2 interventions thought to increase slow wave activity (mindfulness meditation or neurofeedback training) or no enhancing intervention, and then given 5 sessions of self-hypnosis training targeting their presenting symptoms. The findings supported the potential for both neurofeedback and mindfulness to enhance response to hypnosis treatment. Research using larger sample sizes to determine the generalizability of these findings is warranted.

Randomized prospective study comparing vancomycin with teicoplanin in the treatment of infections associated with Hickman catheters.

Science.gov (United States)

Smith, S R; Cheesbrough, J; Spearing, R; Davies, J M

1989-08-01

In 72 episodes of suspected or proven Hickman-catheter-associated infection occurring in 59 patients with various hematological disorders, patients were assigned to treatment with either vancomycin or teicoplanin in a randomized nonblinded prospective study. Of 60 episodes evaluable for response, 28 were treated with vancomycin and 32 were treated with teicoplanin. Sixteen infective episodes were microbiologically documented in the vancomycin group, and twenty-one were microbiologically documented in the teicoplanin group. Microbiologically and clinically documented infections treated with vancomycin had an 80% response rate, compared with a 69% response rate for those treated with teicoplanin (P = 0.316). Adverse events occurred in nine (25%) of the episodes in the vancomycin group, compared with three (8%) in the teicoplanin group (P = 0.044). Teicoplanin may provide an effective alternative to vancomycin in the treatment of Hickman-catheter-associated infection in patients with hematological malignancies.

Efficacy of a biobehavioral intervention for hot flashes: a randomized controlled pilot study.

Science.gov (United States)

Barton, Debra L; Schroeder, Kelliann C Fee; Banerjee, Tanima; Wolf, Sherry; Keith, Timothy Z; Elkins, Gary

2017-07-01

The need for effective nonhormonal treatments for hot flash management without unwanted side effects continues. The primary aim of this pilot study was to evaluate the effect of combining a nonhormonal pharmacologic agent with a behavioral treatment for hot flash reduction. Seventy-one postmenopausal women were randomized to one of four groups: venlafaxine 75 mg + hypnosis (VH) versus venlafaxine 75 mg + sham hypnosis (VSH) versus a placebo pill + hypnosis (PH) versus placebo pill + sham hypnosis (PSH). Women recorded hot flash severity and frequency in a daily diary, in real time. The intrapatient difference in hot flash score (frequency × severity) at 8 weeks was analyzed using a General Estimating Equation model, using VSH as the referent arm, controlling for baseline hot flashes. The active arms including PH or VH were not statistically significantly different than VSH (P = 0.34, P = 0.05, respectively). Women in each active arm reported hot flash reductions of about 50%, with the PSH group reporting a 25% reduction. Women receiving the PSH reported statistically significantly smaller reductions in hot flash score than women in the referent VSH arm (P = 0.001). There were no significant negative side effects during the course of the study. Hypnosis alone reduced hot flashes equal to venlafaxine alone, but the combination of hypnosis and venlafaxine did not reduce hot flashes more than either treatment alone. More research is needed to clarify whether combining hypnosis with a different antidepressant would provide synergistic benefits.

Linking the Pilot Structural Model and Pilot Workload

Science.gov (United States)

Bachelder, Edward; Hess, Ronald; Aponso, Bimal; Godfroy-Cooper, Martine

2018-01-01

Behavioral models are developed that closely reproduced pulsive control response of two pilots using markedly different control techniques while conducting a tracking task. An intriguing find was that the pilots appeared to: 1) produce a continuous, internally-generated stick signal that they integrated in time; 2) integrate the actual stick position; and 3) compare the two integrations to either issue or cease a pulse command. This suggests that the pilots utilized kinesthetic feedback in order to sense and integrate stick position, supporting the hypothesis that pilots can access and employ the proprioceptive inner feedback loop proposed by Hess's pilot Structural Model. A Pilot Cost Index was developed, whose elements include estimated workload, performance, and the degree to which the pilot employs kinesthetic feedback. Preliminary results suggest that a pilot's operating point (parameter values) may be based on control style and index minimization.

A psycho-educational HIV/STI prevention intervention for internally displaced women in Leogane, Haiti: results from a non-randomized cohort pilot study.

Directory of Open Access Journals (Sweden)

Carmen H Logie

Full Text Available Little evidence exists regarding efficacious HIV and sexually transmitted infections (STI prevention interventions with internally displaced populations. Internally displaced women are at elevated risk for HIV/STI due to limited access to health services, heightened poverty and social network breakdown. The FASY (Famn an Aksyon Pou Sante' Yo (Women Taking Action For Their Health study examined the effectiveness of a peer health worker (PHW delivered psycho-educational HIV/STI pilot study with internally displaced women in Leogane, Haiti.This was a non-randomized cohort pilot study. Participants completed a computer-assisted pre-test programmed on Android tablet PCs followed by an HIV/STI educational video-based session and a 6-week psycho-educational group program of weekly meetings. Participants completed a post-test upon completion of group sessions. The primary outcome was HIV knowledge; our pre-specified index of clinically significant change was an effect size of 0.30. Secondary outcomes included: STI knowledge, condom use, social support, resilient coping, depression and relationship control. We used mixed-effects regression to calculate mean outcome pre-post score change. This study was registered (clinicaltrials.gov, NCT01492829.Between January 1-April 30, 2012 we assigned 200 participants to the study. The majority of participants (n = 176, 88% completed the study and were followed up at 8 weeks, finishing April 30, 2012. Adjusted for socio-demographic characteristics, HIV knowledge (β = 4.81; 95% CI 4.36-5.26, STI knowledge (β = 0.84; 95% CI 0.70-0.99, condom use (AOR = 4.05, 95% CI 1.86-8.83, and depression (β = -0.63, 95% CI -0.88--0.39 scores showed statistically significant change post-intervention (p<0.05.This pilot study evaluated a PHW psycho-educational HIV/STI prevention intervention among internally displaced women in post-earthquake Haiti. Pilot studies are an important approach to understand feasibility and scientific

Efficacy and safety of oral alitretinoin in severe oral lichen planus--results of a prospective pilot study.

Science.gov (United States)

Kunz, M; Urosevic-Maiwald, M; Goldinger, S M; Frauchiger, A L; Dreier, J; Belloni, B; Mangana, J; Jenni, D; Dippel, M; Cozzio, A; Guenova, E; Kamarachev, J; French, L E; Dummer, R

2016-02-01

Patients with severe oral lichen planus refractory to standard topical treatment currently have limited options of therapy suitable for long-term use. Oral alitretinoin (9-cis retinoic acid) was never systematically investigated in clinical trials, although case reports suggest its possible efficacy. To assess the efficacy and safety of oral alitretinoin taken at 30 mg once daily for up to 24 weeks in the treatment of severe oral lichen planus refractory to standard topical therapy. We conducted a prospective open-label single arm pilot study to test the efficacy and safety of 30 mg oral alitretinoin once daily for up to 24 weeks in severe oral lichen planus. Ten patients were included in the study. Primary end point was reduction in signs and symptoms measured by the Escudier severity score. Secondary parameters included pain and quality of life scores. Safety parameters were assessed during a follow-up period of 5 weeks. A substantial response at the end of treatment, i.e. >50% reduction in disease severity measured by the Escudier severity score, was apparent in 40% of patients. Therapy was well tolerated. Adverse events were mild and included headache, mucocutaneous dryness, musculoskeletal pain, increased thyroid-stimulating hormone and dyslipidaemia. Alitretinoin given at 30 mg daily reduced disease severity of severe oral lichen planus in a substantial proportion of patients refractory to standard treatment, was well tolerated and may thus represent one therapeutic option for this special group of patients. © 2015 European Academy of Dermatology and Venereology.

Simulation-based inter-professional education to improve attitudes towards collaborative practice: a prospective comparative pilot study in a Chinese medical centre.

Science.gov (United States)

Yang, Ling-Yu; Yang, Ying-Ying; Huang, Chia-Chang; Liang, Jen-Feng; Lee, Fa-Yauh; Cheng, Hao-Min; Huang, Chin-Chou; Kao, Shou-Yen

2017-11-08

Inter-professional education (IPE) builds inter-professional collaboration (IPC) attitude/skills of health professionals. This interventional IPE programme evaluates whether benchmarking sharing can successfully cultivate seed instructors responsible for improving their team members' IPC attitudes. Prospective, pre-post comparative cross-sectional pilot study. Thirty four physicians, 30 nurses and 24 pharmacists, who volunteered to be trained as seed instructors participated in 3.5-hour preparation and 3.5-hour simulation courses. Then, participants (n=88) drew lots to decide 44 presenters, half of each profession, who needed to prepare IPC benchmarking and formed Group 1. The remaining participants formed Group 2 (regular). Facilitators rated the Group 1 participants' degree of appropriate transfer and sustainable practice of the learnt IPC skills in the workplace according to successful IPC examples in their benchmarking sharing. For the three professions, improvement in IPC attitude was identified by sequential increase in the post-course (second month, T 2 ) and end-of-study (third month, T 3 ) Interdisciplinary Education Perception Scale (IEPS) and Attitudes Towards Healthcare Teams Scale (ATHCTS) scores, compared with pre-course (first month, T 1 ) scores. By IEPS and ATHCTS-based assessment, the degree of sequential improvements in IPC attitude was found to be higher among nurses and pharmacists than in physicians. In benchmarking sharing, the facilitators' agreement about the degree of participants'appropriate transfer and sustainable practice learnt 'communication and teamwork' skills in the workplace were significantly higher among pharmacists and nurses than among physicians. The post-intervention random sampling survey (sixth month, T post ) found that the IPC attitude of the three professions improved after on-site IPC skill promotion by new programme-trained seed instructors within teams. Addition of benchmark sharing to a diamond-based IPE simulation

Hemodialysis Infection Prevention Protocols Ontario—Shower Technique (HIPPO-ST: A Pilot Randomized Trial

Directory of Open Access Journals (Sweden)

S. Daisy Kosa

2017-03-01

Discussion: This HIPPO-ST pilot study demonstrated the feasibility of the larger HIPPO-ST study, especially given the high levels of education success with the HIPPO-ST arm and the low levels of contamination in the control arm.

High dose Senna or Poly Ethylene Glycol (PEG for elective colonoscopy preparation: a prospective randomized investigator-blinded clinical trial

Directory of Open Access Journals (Sweden)

Ahmad Shavakhi

2011-01-01

Full Text Available Background: The aim of this study was to determine the efficacy of two methods of colon preparation for colon cleansing in a randomized controlled trial. Methods: In this prospective randomized investigator-blinded trial, consecutive outpatients indicated for elective colonoscopy were randomized into two groups. Patients in Senna group took 24 tablets of 11 mg Senna in two divided doses 24 hour before colonoscopy. In Poly Ethylene Glycol (PEG group they solved 4 sachets in 4 liters of water the day before the procedure and were asked to drink 250 ml every 15 minutes. The overall quality of colon cleansing was evaluated using the Aronchick scoring scale. Difficulty of the procedure, patients′ tolerance and compliance and adverse events were also evaluated. Results: 322 patients were enrolled in the study. There was no significant difference in the quality of colon cleansing, patients′ tolerance, compliance and the difficulty of the procedure between two groups (p > 0.05. The incidence of adverse effects was similar between two groups except for abdominal pain that was more severe in Senna group (p < 0.05 and nausea and vomiting that was more common in PEG group (p < 0.05 Conclusions: In conclusion we deduce that Senna has the same efficacy and patient′s acceptance as Polyethylene glycol-electrolyte solution (PEG-ES and it could be prescribed as an alternative method for bowel preparation.

Smartphone-Enabled Health Coaching Intervention (iMOVE) to Promote Long-Term Maintenance of Physical Activity in Breast Cancer Survivors: Protocol for a Feasibility Pilot Randomized Controlled Trial

Science.gov (United States)

Ritvo, Paul; Obadia, Maya; Santa Mina, Daniel; Alibhai, Shabbir; Sabiston, Catherine; Oh, Paul; Campbell, Kristin; McCready, David; Auger, Leslie

2017-01-01

Background Although physical activity has been shown to contribute to long-term disease control and health in breast cancer survivors, a majority of breast cancer survivors do not meet physical activity guidelines. Past research has focused on promoting physical activity components for short-term breast cancer survivor benefits, but insufficient attention has been devoted to long-term outcomes and sustained exercise adherence. We are assessing a health coach intervention (iMOVE) that uses mobile technology to increase and sustain physical activity maintenance in initially inactive breast cancer survivors. Objective This pilot randomized controlled trial (RCT) is an initial step in evaluating the iMOVE intervention and will inform development of a full-scale pragmatic RCT. Methods We will enroll 107 physically inactive breast cancer survivors and randomly assign them to intervention or control groups at the University Health Network, a tertiary cancer care center in Toronto, Canada. Participants will be women (age 18 to 74 years) stratified by age (55 years and older/younger than 55 years) and adjuvant hormone therapy (AHT) exposure (AHT vs no AHT) following breast cancer treatment with no metastases or recurrence who report less than 60 minutes of preplanned physical activity per week. Both intervention and control groups receive the 12-week physical activity program with weekly group sessions and an individualized, progressive, home-based exercise program. The intervention group will additionally receive (1) 10 telephone-based health coaching sessions, (2) smartphone with data plan, if needed, (3) supportive health tracking software (Connected Wellness, NexJ Health Inc), and (4) a wearable step-counting device linked to a smartphone program. Results We will be assessing recruitment rates; acceptability reflected in selective, semistructured interviews; and enrollment, retention, and adherence quantitative intervention markers as pilot outcome measures. The primary

What Is the Outcome of an Incision and Drainage Procedure in Endodontic Patients? A Prospective, Randomized, Single-blind Study.

Science.gov (United States)

Beus, Hannah; Fowler, Sara; Drum, Melissa; Reader, Al; Nusstein, John; Beck, Mike; Jatana, Courtney

2018-02-01

There are no prospective endodontic studies to determine the outcome of an incision and drainage (I&D) procedure for swelling in healthy, endodontic patients. The purpose of this prospective, randomized, single-blind study was to compare the postoperative course of I&D with drain placement versus a mock I&D procedure with mock drain placement after endodontic debridement in swollen emergency patients with symptomatic teeth and a pulpal diagnosis of necrosis. Eighty-one adult emergency patients presenting with clinical swelling received either penicillin or, if allergic, clindamycin and complete endodontic debridement, and then were randomly divided into 2 treatment groups: I&D with drain placement or a mock I&D procedure with mock drain placement. At the end of the appointment, all patients received a combination of ibuprofen/acetaminophen and, if needed, an opioid-containing escape medication. Patients recorded their pain and medication use for 4 days postoperatively. Success was defined as no or mild postoperative pain and no use of an opioid-containing escape medication. Success was evaluated using repeated measure mixed model logistic regression. Both groups had a decrease in postoperative pain and medication use over the 4 days. The mock I&D group had significantly higher success than the I&D group (odds ratio = 2.00; 95% confidence interval, 1.16-3.41). The success rate was 45% with the mock I&D and 33% with the I&D. After endodontic debridement, patients who received a mock I&D procedure with mock drain placement had more success than patients who received I&D with drain placement. Both groups clinically improved over 4 days. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Randomized Controlled Trial of Problem-Solving Therapy for Minor Depression in Home Care

Science.gov (United States)

Gellis, Zvi D.; McGinty, Jean; Tierney, Lynda; Jordan, Cindy; Burton, Jean; Misener, Elizabeth

2008-01-01

Objective: Data are presented from a pilot research program initiated to develop, refine, and test the outcomes of problem-solving therapy that targets the needs of older adults with minor depression in home care settings. Method: A pilot randomized clinical trial compares the impact of problem-solving therapy for home care to treatment as usual…

Efficacy of the natural antioxidant astaxanthin in the treatment of functional dyspepsia in patients with or without Helicobacter pylori infection: a prospective, randomized, double blind, and placebo-controlled study5

DEFF Research Database (Denmark)

Kupcinskas, L.; Lafolie, P.; Lignell, A.

2008-01-01

OBJECTIVES: The aim of this study was to evaluate the efficacy of the natural antioxidant astaxanthin in functional dyspepsia in different doses and compared with placebo. DESIGN: The study was a controlled, prospective, randomized, and double blind trial. PARTICIPANTS: Patients with functional d...

Internet-Based Guided Self-Help for Vaginal Penetration Difficulties: Results of a Randomized Controlled Pilot Trial.

Science.gov (United States)

Zarski, Anna-Carlotta; Berking, Matthias; Fackiner, Christina; Rosenau, Christian; Ebert, David Daniel

2017-02-01

Difficulties with vaginal penetration can severely affect a woman's desire to have sexual intercourse, her sexual and general well-being, or her partnership. However, treatment opportunities for vaginismus are scarce. To evaluate the efficacy of an internet-based guided self-help intervention for vaginismus in a randomized controlled pilot trial. Seventy-seven women with vaginismus (primary inclusion criterion = no intercourse ≥ 6 months) were randomly assigned to an intervention group (IG) and a waitlist control group (WCG). The intervention consisted of 10 sessions involving psychoeducation, relaxation exercises, sensate focus, and gradual exposure with dilators. Participants received written feedback on completed sessions from an eCoach. The primary outcome was successful sexual intercourse. Secondary outcomes were non-intercourse penetration, fear of coitus, sexual functioning, and dyadic coping. Self-reported assessments were scheduled at baseline, 10 weeks, and 6 months. More participants (10 of 40, 34.48%) in the IG had intercourse compared with those in the WCG (6 of 37, 20.69%) at least once at 10 weeks or 6 months (odds ratio = 2.02). The difference was not significant (χ 2 1  = 1.38, P = .38), but in the IG, there was a significant increase in intercourse penetration from baseline to 6 months (d = 0.65). No such increase was found in the WCG (d = 0.21). There were significant between-group effects concerning non-intercourse penetration (self-insertion of a finger or dilator or insertion by the partner) in favor of the IG. Fear of coitus and dyadic coping significantly decreased in the IG. Overall satisfaction with the training was high. This randomized controlled trial showed promising effects of an internet-based intervention by increasing participants' ability to have intercourse and non-intercourse penetration while experiencing high treatment satisfaction. The WCG also showed improvement, although participants had vaginismus for an average

A Multidisciplinary Intervention Utilizing Virtual Communication Tools to Reduce Health Disparities: A Pilot Randomized Controlled Trial

Directory of Open Access Journals (Sweden)

John F. Emerson

2015-12-01

Full Text Available Advances in technology are likely to provide new approaches to address healthcare disparities for high-risk populations. This study explores the feasibility of a new approach to health disparities research using a multidisciplinary intervention and advanced communication technology to improve patient access to care and chronic disease management. A high-risk cohort of uninsured, poorly-controlled diabetic patients was identified then randomized pre-consent with stratification by geographic region to receive either the intervention or usual care. Prior to enrollment, participants were screened for readiness to make a behavioral change. The primary outcome was the feasibility of protocol implementation, and secondary outcomes included the use of patient-centered medical home (PCMH services and markers of chronic disease control. The intervention included a standardized needs assessment, individualized care plan, intensive management by a multidisciplinary team, including health coach-facilitated virtual visits, and the use of a cloud-based glucose monitoring system. One-hundred twenty-seven high-risk, potentially eligible participants were randomized. Sixty-one met eligibility criteria after an in-depth review. Due to limited resources and time for the pilot, we only attempted to contact 36 participants. Of these, we successfully reached 20 (32% by phone and conducted a readiness to change screen. Ten participants screened in as ready to change and were enrolled, while the remaining 10 were not ready to change. Eight enrolled participants completed the final three-month follow-up. Intervention feasibility was demonstrated through successful implementation of 13 out of 14 health coach-facilitated virtual visits, and 100% of participants indicated that they would recommend the intervention to a friend. Protocol feasibility was demonstrated as eight of 10 participants completed the entire study protocol. At the end of the three-month intervention

A double-blind randomized pilot trial comparing computerized cognitive exercises to Tetris in adolescents with attention-deficit/hyperactivity disorder.

Science.gov (United States)

Bikic, Aida; Christensen, Torben Østergaard; Leckman, James F; Bilenberg, Niels; Dalsgaard, Søren

2017-08-01

The purpose of this trial was to examine the feasibility and efficacy of computerized cognitive exercises from Scientific Brain Training (SBT), compared to the computer game Tetris as an active placebo, in a pilot study of adolescents with attention-deficit/hyperactivity disorder (ADHD). Eighteen adolescents with ADHD were randomized to treatment or control intervention for 7 weeks. Outcome measures were cognitive test, symptom, and motivation questionnaires. SBT and Tetris were feasible as home-based interventions, and participants' compliance was high, but participants perceived both interventions as not very interesting or helpful. There were no significant group differences on cognitive and ADHD-symptom measures after intervention. Pre-post intra-group measurement showed that the SBT had a significant beneficial effect on sustained attention, while the active placebo had significant beneficial effects on working memory, both with large effect sizes. Although no significant differences were found between groups on any measure, there were significant intra-group changes for each group.

The effect of tourniquet use on fixation quality in cemented total knee arthroplasty a prospective randomized clinical controlled RSA trial.

Science.gov (United States)

Molt, Mats; Harsten, Andreas; Toksvig-Larsen, Sören

2014-03-01

A concern that arises with any change in technique is whether it affects the long-term implant stability. The objective of this study was to evaluate the early migration, measured by radiostereometric analysis (RSA), and the functional outcome of the Triathlon™ cemented knee prosthesis, operated on with or without a tourniquet. During the last decades RSA has emerged as a way to assess prosthetic fixation and long time prognosis. The method has been used extensively in both hip and knee arthroplasty. This was a single centre prospective study including 60 patients randomized into two groups operated on either with or without tourniquet. RSA investigation was done within 2-3 days postoperatively after full weight bearing, and then at 3 months, 1 year and 2 years postoperatively. There were no differences between the groups regarding the translation along or rotation around the three coordinal axes, or in maximum total point motion (MTPM). At 2 years the mean MTPM (SD) was 0.71 mm (0.64) for the tourniquet-group and 0.53 mm (0.21) for the non-tourniquet-group. The tibial tray of the Triathlon™ cemented knee prosthesis showed similar early stability whether operated on with or without tourniquet. Level I. Article focus: A safety study for total knee replacement operated on with or without perioperative tourniquet regarding the prosthetic fixation. Strengths and limitations: Strength of this study is that it is a randomized prospective trial using an objective measuring tool. The sample size of 25-30 patients is reportedly sufficient for the screening of implants using RSA (1-3). Clinical trials NCT01604382, Ethics Committee approval D-nr: 144/20085. © 2013.

Randomized controlled trial evaluating the temporal effects of high-intensity exercise on learning, short-term and long-term memory, and prospective memory.

Science.gov (United States)

Frith, Emily; Sng, Eveleen; Loprinzi, Paul D

2017-11-01

The broader purpose of this study was to examine the temporal effects of high-intensity exercise on learning, short-term and long-term retrospective memory and prospective memory. Among a sample of 88 young adult participants, 22 were randomized into one of four different groups: exercise before learning, control group, exercise during learning, and exercise after learning. The retrospective assessments (learning, short-term and long-term memory) were assessed using the Rey Auditory Verbal Learning Test. Long-term memory including a 20-min and 24-hr follow-up assessment. Prospective memory was assessed using a time-based procedure by having participants contact (via phone) the researchers at a follow-up time period. The exercise stimulus included a 15-min bout of progressive maximal exertion treadmill exercise. High-intensity exercise prior to memory encoding (vs. exercise during memory encoding or consolidation) was effective in enhancing long-term memory (for both 20-min and 24-h follow-up assessments). We did not observe a differential temporal effect of high-intensity exercise on short-term memory (immediate post-memory encoding), learning or prospective memory. The timing of high-intensity exercise may play an important role in facilitating long-term memory. © 2017 Federation of European Neuroscience Societies and John Wiley & Sons Ltd.

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

Science.gov (United States)

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

2016-12-01

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

Effect of Raw Milk on Lactose Intolerance: A Randomized Controlled Pilot Study

Science.gov (United States)

Mummah, Sarah; Oelrich, Beibei; Hope, Jessica; Vu, Quyen; Gardner, Christopher D.

2014-01-01

PURPOSE This pilot study aimed to determine whether raw milk reduces lactose malabsorption and/or lactose intolerance symptoms relative to pasteurized milk. METHODS We performed a crossover trial involving 16 adults with self-reported lactose intolerance and lactose malabsorption confirmed by hydrogen (H2) breath testing. Participants underwent 3, 8-day milk phases (raw vs 2 controls: pasteurized, soy) in randomized order separated by 1-week washout periods. On days 1 and 8 of each phase, milk consumption was 473 mL (16 oz); on days 2 to 7, milk dosage increased daily by 118 mL (4 oz), beginning with 118 mL (4 oz) on day 2 and reaching 710 mL (24 oz) on day 7. Outcomes were area under the breath H2 curve (AUC ∆H2) and self-reported symptom severity (visual analog scales: flatulence/gas, audible bowel sounds, abdominal cramping, diarrhea). RESULTS AUC ∆H2 (mean ± standard error of the mean) was higher for raw vs pasteurized on day 1 (113 ± 21 vs 71 ± 12 ppm·min·10−2, respectively, P = .01) but not day 8 (72 ± 14 vs 74 ± 15 ppm·min·10−2, respectively, P = .9). Symptom severities were not different for raw vs pasteurized on day 7 with the highest dosage (P >.7). AUC ∆H2 and symptom severities were higher for both dairy milks compared with soy milk. CONCLUSIONS Raw milk failed to reduce lactose malabsorption or lactose intolerance symptoms compared with pasteurized milk among adults positive for lactose malabsorption. These results do not support widespread anecdotal claims that raw milk reduces the symptoms of lactose intolerance. PMID:24615309

Self-compassion training for binge eating disorder: a pilot randomized controlled trial.

Science.gov (United States)

Kelly, Allison C; Carter, Jacqueline C

2015-09-01

The present pilot study sought to compare a compassion-focused therapy (CFT)-based self-help intervention for binge eating disorder (BED) to a behaviourally based intervention. Forty-one individuals with BED were randomly assigned to 3 weeks of food planning plus self-compassion exercises; food planning plus behavioural strategies; or a wait-list control condition. Participants completed weekly measures of binge eating and self-compassion; pre- and post-intervention measures of eating disorder pathology and depressive symptoms; and a baseline measure assessing fear of self-compassion. Results showed that: (1) perceived credibility, expectancy, and compliance did not differ between the two interventions; (2) both interventions reduced weekly binge days more than the control condition; (3) the self-compassion intervention reduced global eating disorder pathology, eating concerns, and weight concerns more than the other conditions; (4) the self-compassion intervention increased self-compassion more than the other conditions; and (5) participants low in fear of self-compassion derived significantly more benefits from the self-compassion intervention than those high in fear of self-compassion. Findings offer preliminary support for the usefulness of CFT-based interventions for BED sufferers. Results also suggest that for individuals to benefit from self-compassion training, assessing and lowering fear of self-compassion will be crucial. Individuals with BED perceive self-compassion training self-help interventions, derived from CFT, to be as credible and as likely to help as behaviourally based interventions. The cultivation of self-compassion may be an effective approach for reducing binge eating, and eating, and weight concerns in individuals with BED. Teaching individuals with BED CFT-based self-help exercises may increase their self-compassion levels over a short period of time. It may be important for clinicians to assess and target clients' fear of self

75 FR 56857 - Pilot, Flight Instructor, and Pilot School Certification

Science.gov (United States)

2010-09-17

...-2006-26661; Amendment No., 141-14] RIN 2120-AI86 Pilot, Flight Instructor, and Pilot School..., certification, and operating requirements for pilots, flight instructors, ground instructors, and pilot schools...: Background On August 21, 2009, the FAA published the ``Pilot, Flight Instructor, and Pilot School...

Development of an attention-touch control for manual cervical distraction: a pilot randomized clinical trial for patients with neck pain.

Science.gov (United States)

Gudavalli, M Ram; Salsbury, Stacie A; Vining, Robert D; Long, Cynthia R; Corber, Lance; Patwardhan, Avinash G; Goertz, Christine M

2015-06-05

Manual cervical distraction (MCD) is a traction-based therapy performed with a manual contact over the cervical region producing repeating cycles while patients lie prone. This study evaluated a traction force-based minimal intervention for use as an attention-touch control in clinical trials of MCD for patients with chronic neck pain. We conducted a mixed-methods, pilot randomized clinical trial in adults with chronic neck pain. Participants were allocated to three traction force ranges of MCD: low force/minimal intervention (0-20 N), medium force (21-50 N), or high force (51-100 N). Clinicians delivered five treatments over two weeks consisting of three sets of five cycles of MCD at the C5 vertebra and occiput. Traction forces were measured at each treatment. Patient-reported outcomes included a pain visual analogue scale (VAS), Neck Disability Index (NDI), Credibility and Expectancy Questionnaire (CEQ), and adverse effects. A qualitative interview evaluated treatment group allocation perceptions. We randomized 48 participants, allocating an average of five each month. Forty-five participants completed the trial with three participants lost to follow-up. Most participants were women (65%) and white (92%) with a mean (SD) age of 46.8 (12.5) years. Mean traction force values were within the prescribed force ranges for each group at the C5 and occiput levels. Neck pain VAS demonstrated a benefit for high traction force MCD compared to the low force group [adjusted mean difference 15.6; 95% confidence interval (CI) 1.6 to 29.7]. Participants in the medium traction force group demonstrated improvements in NDI compared to the low force group (adjusted mean difference 3.0; 95% CI 0.1 to 5.9), as did participants in the high traction force group (adjusted mean difference 2.7; 95% CI -0.1 to 5.6). CEQ favored the high force group. Most low force participants correctly identified their treatment allocation in the qualitative interview. No serious adverse events were

Pilot randomized crossover study comparing the efficacy of transnasal disposable endosheath with standard endoscopy to detect Barrett's esophagus.

Science.gov (United States)

Shariff, Mohammed K; Varghese, Sibu; O'Donovan, Maria; Abdullahi, Zarah; Liu, Xinxue; Fitzgerald, Rebecca C; di Pietro, Massimiliano

2016-02-01

The transnasal endosheath endoscope is a new disposable technology with potential applicability to the primary care setting. The aim of this study was to evaluate the efficacy of transnasal endosheath endoscopy (TEE) for the detection of Barrett's esophagus, by comparing the diagnostic accuracy of TEE with that of standard endoscopy. This was a prospective, randomized, crossover study performed in a single tertiary referral center. Consecutive patients undergoing surveillance for Barrett's esophagus or referred for diagnostic assessment were recruited. All patients were randomized to undergo TEE followed by standard endoscopy or the reverse. Endoscopy experiences and patient preferences were evaluated using a questionnaire. Endoscopic and histologic diagnosis of Barrett's esophagus, and optical image quality of both endoscopic procedures, were compared. A total of 21 of 25 patients completed the study. TEE had sensitivity and specificity of 100 % for an endoscopic diagnosis of Barrett's esophagus, and of 66.7 % and 100 %, respectively, for the histologic diagnosis of Barrett's esophagus. The mean optical quality of standard endoscopy was significantly better than that of TEE (7.11 ± 0.42 vs. 4.06 ± 0.27; P evaluation in primary care as an initial diagnostic tool. © Georg Thieme Verlag KG Stuttgart · New York.

A five-day inpatient EMDR treatment programme for PTSD: pilot study

NARCIS (Netherlands)

Zepeda Méndez, Mayaris; Nijdam, Mirjam J.; ter Heide, F. Jackie June; van der Aa, Niels; Olff, Miranda

2018-01-01

Conclusions: The majority of patients in our pilot study experienced symptom reduction consistent with reliable changes in this five-day inpatient treatment with EMDR and yoga. Randomized controlled trials - with longer follow up periods - are needed to properly determine efficacy and efficiency of

Comparison of the effects of sodium hyaluronate-chondroitin sulphate and corticosteroid in the treatment of lateral epicondylitis: a prospective randomized trial.

Science.gov (United States)

Tosun, Haci Bayram; Gumustas, Seyitali; Agir, Ismail; Uludag, Abuzer; Serbest, Sancar; Pepele, Demet; Ertem, Kadir

2015-09-01

Hyaluronic acid and glycosaminoglycans have shown positive effects in improving lateral epicondylitis and other tendinosis conditions. Therefore, we designed a prospective, randomized study to compare the effects of a combined sodium hyaluronate and chondroitin sulfate (HA + CS) injection versus a triamcinolone injection in the treatment of lateral epicondylitis. In total, 57 consecutive patients with clinically diagnosed lateral epicondylitis were divided randomly into two groups. In the HA + CS group, 25 patients received a single injection of a solution containing an HA + CS combination and prilocaine HCl, while the 32 patients in the triamcinolone group received a single injection of a solution of triamcinolone and prilocaine HCl. We evaluated the pain and function outcome measures using the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire at the beginning of the study, and 3 and 6 months after the injection. Additionally, the Minimum Clinically Important Difference values and percentage changes in the PRTEE subscale scores between the assessments were calculated. No serious adverse events were reported throughout the study. The mean pain and function scores for the HA + CS and triamcinolone groups had significantly improved at 3 months, but the mean function scores in the HA + CS group were statistically significantly better when compared to the triamcinolone group. At 6 months, both groups had significantly improved mean pain and function scores, compared to the baseline scores; however, the mean pain and function scores in the 6-month HA + CS treatment group were better than in the 6-month triamcinolone group. The relative change for the mean total score in the HA + CS group was much better when compared with the triamcinolone group, and the HA + CS treatment group showed clinically significant improvement when compared with triamcinolone group at 3 and 6 months. This study supports the idea that for a single injection treatment of patients with

'Huang Qi Elixir' for proteinuria in patients with diabetic nephropathy: a study protocol for a randomized controlled pilot trial.

Science.gov (United States)

Tu, Xiang; Liu, Fang; Jordan, James B; Ye, Xue Feng; Fu, Ping; Wang, Fei; Zhong, Sen

2013-07-18

Diabetic nephropathy (DN) is the major complication of diabetes; proteinuria is the hall mark of DN. Currently, the treatment for proteinuria is mainly limited to angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs). According to Traditional Chinese Medicine (TCM) theory, Chinese medicinals 'securing essence and tonifying the kidney' may be appropriate for proteinuria. The most promising Chinese medicinals and formulae are introduced in the present study to form a potent formula for DN proteinuria. To make oral administration convenient, the formula will be processed in the form of granules. A randomized, multi-center pilot trial will be conducted. Forty eight participants with DN will be randomly assigned to one of four treatment groups: 1. A granule group, at 10 grams, three times daily (G10 group, n = 12); 2. A granule group, at 20 grams, three times daily (G20 group, n = 12); 3. A decoction group (D group, n = 12); and 4. An irbesartan group (Aprovel group, n = 12).The following outcome measures will be used: the percentage change of the albumin-to-creatinine ratio; and the changes in serum creatinine, glomerular filtration rate, fasting plasma glucose and hemoglobulin from baseline to the end of the trial. It is notable that most published clinical trials which assessed the efficacy of TCM on DN were of poor methodology and, therefore, their results have been invalidated. It is necessary to carry out well-designed clinical trials to provide sound evidence. The present trial is a study with potentially great value, for it will provide the parameters for future randomized, placebo-controlled, clinical trials with large sample sizes. The trial is registered on the Chinese Clinical Trial Registry: ChiCTR-TRC-12002718 (http://www.chictr.org/cn/proj/show.aspx?proj=3820).

Effects of pilot holes on longitudinal miniscrew stability and bony adaptation.

Science.gov (United States)

Carney, Lauren Ohlenforst; Campbell, Phillip M; Spears, Robert; Ceen, Richard F; Melo, Ana Cláudia; Buschang, Peter H

2014-11-01

The purposes of this study were to longitudinally evaluate the effects of pilot holes on miniscrew implant (MSI) stability and to determine whether the effects can be attributed to the quality or the quantity of bone surrounding the MSI. Using a randomized split-mouth design in 6 skeletally mature female foxhound-mix dogs, 17 MSIs (1.6 mm outer diameter) placed with pilot holes (1.1 mm) were compared with 17 identical MSIs placed without pilot holes. Implant stability quotient measurements of MSI stability were taken weekly for 7 weeks. Using microcomputed tomography with an isotropic resolution of 6 μm, bone volume fractions were measured for 3 layers of bone (6-24, 24-42, and 42-60 μm) surrounding the MSIs. At placement, the MSIs with pilot holes showed significantly (P holes (48.3 vs 47.5). Over time, the implant stability quotient values decreased significantly more for the MSIs placed with pilot holes than for those placed without pilot holes. After 7 weeks, the most coronal aspect of the 6- to 24-μm layer of cortical bone and the most coronal aspects of all 3 layers of trabecular bone showed significantly larger bone volume fractions for the MSIs placed without pilot holes than for those placed with pilot holes. MSIs placed with pilot holes show greater primary stability, but greater decreases in stability over time, due primarily to having less trabecular bone surrounding them. Copyright © 2014 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

Preliminary evidence that glucose ingestion facilitates prospective memory performance.

Science.gov (United States)

Riby, Leigh M; Law, Anna S; McLaughlin, Jennifer; Murray, Jennifer

2011-05-01

Previous research has found that the ingestion of glucose boosts task performance in the memory domain (including tasks tapping episodic, semantic, and working memory). The present pilot study tested the hypothesis that glucose ingestion would enhance performance on a test of prospective memory. In a between-subjects design, 56 adults ranging from 17 to 80 years of age performed a computerized prospective memory task and an attention (filler) task after 25 g of glucose or a sweetness-matched placebo. Blood glucose measurements were also taken to assess the impact of individual differences on glucose regulation. After the drink containing glucose, cognitive facilitation was observed on the prospective memory task after excluding subjects with impaired fasting glucose level. Specifically, subjects receiving glucose were 19% more accurate than subjects receiving a placebo, a trend that was marginally nonsignificant, F₁,₄₁ = 3.4, P = .07, but that had a medium effect size, d = 0.58. Subjects receiving glucose were also significantly faster on the prospective memory task, F₁,₃₅ = 4.8, P glucose (indicative of poor glucose regulation) was associated with slower prospective memory responding, F₁,₃₅ = 4.4, P memory and executive functioning can benefit from the increased provision of glucose to the brain. Copyright © 2011 Elsevier Inc. All rights reserved.

Exercise training as treatment of neck pain among fighter pilots

DEFF Research Database (Denmark)

Murray, Mike; Lange, Britt; Andersen, Christoffer Højnicke

) seldom, trained but stopped, 6) no participation at all. Maximal Voluntary Isometric Contraction (MVC) and Rate of Force Development (RFD) for cervical flexion and extension were measured by strain-gauge transducers. Results Prevalence of neck pain was significantly reduced in ET from baseline (mean ± SD......Introduction Neck and shoulder pain is a common complaint among fighter pilots and a growing aero-medical concern. Unfortunately, previous intervention studies have been unsuccessful in relieving such pain within this occupational group. The aim of this study was to investigate if an exercise...... intervention could reduce the high prevalence of neck pain among fighter pilots. Methods F-16 pilots were randomized in a controlled intervention trial, to either an exercise-training-group (ET, n=27) or reference-group (REF, n=28). ET underwent 24 weeks of strength, endurance, and coordination training, 3...

Nurse-delivered counselling intervention for parental HIV disclosure: Results from a pilot randomized controlled trial in China

Science.gov (United States)

Simoni, Jane M.; Yang, Joyce P.; Shiu, Cheng-Shi; Chen, Wei-ti; Udell, Wadiya; Bao, Meijuan; Zhang, Lin; Lu, Hongzhou

2016-01-01

Objective The objective of this study was to design and conduct a preliminary evaluation of an intervention to assist parents in decision-making about disclosure of their HIV diagnosis to their children. Design This was a pilot randomized controlled trial (RCT) with blinded assessment. Participants were randomized to intervention or treatment-as-usual (TAU) arms. Setting The study occurred at an outpatient HIV primary care centre in Shanghai, China. Participants Participants were 20 HIV-positive outpatients with at least one child (13–25 years old) who was unaware of the parent’s HIV diagnosis. Intervention The nurse-delivered intervention involved three, hour-long, individual sessions over 4 weeks. Intervention content comprised family assessment, discussion of advantages and disadvantages of disclosure, psycho-education about cognitive, social and emotional abilities of children at different developmental stages, and disclosure planning and practicing via role-plays. Main outcome measure(s) Primary study outcomes for intervention versus TAU arms were self-reported disclosure distress, self-efficacy and behaviours along a continuum from no disclosure to full disclosure and open communication about HIV. Results In all cross-sectional (Wald tests) and longitudinal (general estimating equations) analyses, at both postintervention (4 weeks) and follow-up (13 weeks), effects were in the hypothesized directions. Despite the small sample size, most of these between-arm comparisons were statistically significant, with at least one result for each outcome indicating a ‘large’ effect size. Conclusion Our results suggest that nurses are able to deliver a counselling intervention in a clinic setting with the potential to alleviate parental distress around HIV disclosure to their children. Findings warrant future trials powered for efficacy. PMID:26049544

Home-based balance training using the Wii balance board: a randomized, crossover pilot study in multiple sclerosis.

Science.gov (United States)

Prosperini, Luca; Fortuna, Deborah; Giannì, Costanza; Leonardi, Laura; Marchetti, Maria Rita; Pozzilli, Carlo

2013-01-01

To evaluate the effectiveness of a home-based rehabilitation of balance using the Nintendo Wii Balance Board System (WBBS) in patients affected by multiple sclerosis (MS). In this 24-week, randomized, 2-period crossover pilot study, 36 patients having an objective balance disorder were randomly assigned in a 1:1 ratio to 2 counterbalanced arms. Group A started a 12-week period of home-based WBBS training followed by a 12-week period without any intervention; group B received the treatment in reverse order. As endpoints, we considered the mean difference (compared with baseline) in force platform measures (i.e., the displacement of body center of pressure in 30 seconds), 4-step square test (FSST), 25-foot timed walking test (25-FWT), and 29-item MS Impact Scale (MSIS-29), as evaluated after 12 weeks and at the end of the 24-week study period. The 2 groups did not differ in baseline characteristics. Repeated-measures analyses of variance showed significant time × treatment effects, indicating that WBBS was effective in ameliorating force platform measures (F = 4.608, P = .016), FSST (F = 3.745, P = .034), 25-FWT (F = 3.339, P = .048), and MSIS-29 (F = 4.282, P = .023). Five adverse events attributable to the WBSS training (knee or low back pain) were recorded, but only 1 patient had to retire from the study. A home-based WBBS training might potentially provide an effective, engaging, balance rehabilitation solution for people with MS. However, the risk of WBBS training-related injuries should be carefully balanced with benefits. Further studies, including cost-effectiveness analyses, are warranted to establish whether WBBS may be useful in the home setting.

Effects of guided imagery on blood pressure in pregnant women with hypertension: a pilot randomized controlled trial.

Science.gov (United States)

Moffatt, Faith Wight; Hodnett, Ellen; Esplen, Mary Jane; Watt-Watson, Judy

2010-12-01

Hypertension occurs in nearly 10 percent of pregnancies, and is associated with higher risk of infant and maternal morbidity and mortality than in normal pregnancies. Previous studies have suggested that relaxation therapies reduce blood pressure in nonpregnant adults. The objectives of this pilot randomized trial were to provide preliminary evidence of whether relaxation by means of guided imagery would reduce blood pressure in hypertensive pregnant women, and to assess the feasibility of a larger trial. A total of 69 pregnant women with hypertension were randomized to periods of guided imagery or of quiet rest, twice daily for 4 weeks or until delivery, whichever came first. Daytime ambulatory mean arterial pressure, systolic and diastolic blood pressure, and anxiety were measured weekly for up to 4 weeks. Women allocated to guided imagery had lower mean arterial pressure elevations over time than those allocated to quiet rest (guided imagery: M = 1.58 mmHg, SD = 7.63; quiet rest: M = 5.93 mmHg, SD = 6.55; t = 2.36, p = 0.02). However, when adjusted for baseline mean arterial pressure and gestation, the effect was not significant (p = 0.14). Numbers of women prescribed antihypertensive medication postrandomization were similar (guided imagery: n = 16; quiet rest: n = 13, χ(2) = 0.74, p = 0.46). There was also no evidence of an effect on women's anxiety. Nearly 90 percent (n = 26) of the guided imagery group indicated that they would use it again. Further rigorous study is warranted to determine effects of guided imagery on maternal blood pressure and perinatal health outcomes. © 2010, Copyright the Authors. Journal compilation © 2010, Wiley Periodicals, Inc.

Effectiveness of school-based humanistic counselling for psychological distress in young people: Pilot randomized controlled trial with follow-up in an ethnically diverse sample.

Science.gov (United States)

Pearce, Peter; Sewell, Ros; Cooper, Mick; Osman, Sarah; Fugard, Andrew J B; Pybis, Joanne

2017-06-01

The aim of this study was to pilot a test of the effectiveness of school-based humanistic counselling (SBHC) in an ethnically diverse group of young people (aged 11-18 years old), with follow-up assessments at 6 and 9 months. Pilot randomized controlled trial, using linear-mixed effect modelling and intention-to-treat analysis to compare changes in levels of psychological distress for participants in SBHC against usual care (UC). ISRCTN44253140. In total, 64 young people were randomized to either SBHC or UC. Participants were aged between 11 and 18 (M = 14.2, SD = 1.8), with 78.1% of a non-white ethnicity. The primary outcome was psychological distress at 6 weeks (mid-therapy), 12 weeks (end of therapy), 6-month follow-up and 9-month follow-up. Secondary measures included emotional symptoms, self-esteem and attainment of personal goals. Recruitment and retention rates for the study were acceptable. Participants in the SBHC condition, as compared with participants in the UC condition, showed greater reductions in psychological distress and emotional symptoms, and greater improvements in self-esteem, over time. However, at follow-up, only emotional symptoms showed significant differences across groups. The study adds to the pool of evidence suggesting that SBHC can be tested and that it brings about short-term reductions in psychological and emotional distress in young people, across ethnicities. However, there is no evidence of longer-term effects. School-based humanistic counselling can be an effective means of reducing the psychological distress experienced by young people with emotional symptoms in the short term. The short-term effectiveness of school-based humanistic counselling is not limited to young people of a White ethnicity. There is no evidence that school-based humanistic counselling has effects beyond the end of therapy. © 2016 The British Psychological Society.

Pilot study of dornase alfa (Pulmozyme) therapy for acquired ventilator-associated infection in preterm infants.

Science.gov (United States)

Scala, Melissa; Hoy, Deborah; Bautista, Maria; Palafoutas, Judith Jones; Abubakar, Kabir

2017-06-01

Evaluate the feasibility, safety, and efficacy of adjunctive treatment with dornase alfa in preterm patients with ventilator-associated pulmonary infection (VAPI) compared to standard care. We hypothesize that therapy with dornase alfa will be safe and well tolerated in the preterm population with no worsening of symptoms, oxygen requirement, or need for respiratory support. Prospective, randomized, blinded, pilot study comparing adjunctive treatment with dornase alfa to sham therapy. In addition to standard care, infants were randomized to receive dornase alfa 2.5 mg nebulized via endotracheal tube (ETT) every 12 hr for 7 days or sham therapy. ETT secretion gram stain and culture and chest X-ray (CXR) findings were evaluated. Respiratory support data were downloaded from the ventilator. Fourteen infants developed VAPI between 2012 and 2014; 11 enrolled in the study. Six received dornase alfa and five received sham therapy. Average gestational age at birth was 25 weeks and age at study entry was 31 days. There were no differences in demographics, ETT white blood cell count (WBC), CXR, or mean airway pressure (MAP) between the two groups. There was a trend towards decreased oxygen requirement (FiO2) in the treatment group that did not reach statistical significance. No side effects were observed in the treatment group. Treatment with dornase alfa is safe and treated infants had some improvement in FiO 2 requirement but no improvement in MAP. A larger randomized trial is needed to evaluate the efficacy of this therapy. Pediatr Pulmonol. 2017; 52:787-791. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

Comparative analysis of conventional and eversion carotid endarterectomy: Prospective randomized study

Directory of Open Access Journals (Sweden)

Marković Dragan M.

2008-01-01

Full Text Available INTRODUCTION Studies completed in the last decade of the 20th century showed benefits of carotid endarterectomy in the prevention of stroke in patients with a high-grade stenosis of the internal carotid artery. OBJECTIVE The aim of this prospective, randomized study was the comparison of early and long-term results between the conventional and eversion carotid endarterectomy, and literature review. METHOD By the method of random choice, 103 patients were operated on using the eversion carotid endarterectomy and 98 patients using the conventional technique. Operative treatment was carried out under general anaesthesia. Following the clammping of the carotid artery, retrograde blood pressure was determined by a direct puncture of the internal carotid artery above the stenotic lesions. In patients with retrograde pressure below 20 mm Hg intraluminal shunting was routinely performed. Early results were estimated (during the first seven postoperative days based on mortality, central neurological complications (stroke, TIA and cranial or cervical nerve lesions. Long-term results were estimated (after at least two years based on long-term survival rate, central neurological complications (stroke, TIA and the incidence of haemodynamically significant restenosis of the carotid artery treated by endarterectomy. RESULTS The average time of clamming of the internal carotid artery in the eversion carotid anderectomy group was 5.36 minutes shorter than in the group treated by the conventional technique. Student's t-test showed a statistically highly significant difference in the time needed for clamming of the internal carotid artery between the two groups. The average duration of eversion endarterectomy (82 minutes was most often 19 minutes shorter than the duration of the conventional endarterectomy (101 minutes. Student's t-test showed a statistically highly significant difference in the average length of surgeries. The distal intimal fixation was more

Water-based vs. non-water-based physiotherapy for rehabilitation of postural deformities in Parkinson's disease: a randomized controlled pilot study.

Science.gov (United States)

Volpe, Daniele; Giantin, Maria Giulia; Manuela, Pilleri; Filippetto, Consuelo; Pelosin, Elisa; Abbruzzese, Giovanni; Antonini, Angelo

2017-08-01

To compare the efficacy of two physiotherapy protocols (water-based vs. non-water-based) on postural deformities of patients with Parkinson's disease. A single blind, randomized controlled pilot study. Inpatient (Rehabilitative Department). A total of 30 patients with idiopathic Parkinson's disease. Participants were randomly assigned to one of two eight-week treatment groups: Water-based ( n = 15) or non-water-based physiotherapy exercises ( n = 15). Changes in the degree of cervical and dorsal flexion and in the angle of lateral inclination of the trunk (evaluated by means of a posturographic system) were used as primary outcomes. Unified Parkinson Disease Rating Scale section III, Time Up and Go Test, Berg Balance Scale, Activities-specific Balance Confidence, Falls Efficacy Scale and the Parkinson's disease quality of life questionnaire (39 items) were the secondary outcomes. All outcomes were assessed at baseline, at the end of training and eight weeks after treatment. Patients were always tested at the time of their optimal antiparkinsonian medication ('on' phase). After the treatment, only Parkinson's disease subjects randomized to water-based treatment showed a significant improvement of trunk posture with a significant reduction of cervical flexion (water-based group: -65.2°; non-water-based group: +1.7°) and dorsal flexion (water-based group: -22.5°; non-water-based group: -6.5°) and lateral inclination of the trunk (water-based group: -2.3°; non-water-based group: +0.3°). Both groups presented significant improvements in the secondary clinical outcomes without between-group differences. Our results show that water-based physiotherapy was effective for improving postural deformities in patients with Parkinson's disease.

Single-dose intravenous iron infusion versus red blood cell transfusion for the treatment of severe postpartum anaemia: a randomized controlled pilot study.

Science.gov (United States)

Holm, C; Thomsen, L L; Norgaard, A; Langhoff-Roos, J

2017-02-01

There are no randomized trials comparing intravenous iron to RBC transfusion for the treatment of severe postpartum anaemia. The objectives of this study were to evaluate the feasibility of randomizing women with severe postpartum anaemia secondary to postpartum haemorrhage to RBC transfusion or intravenous iron, and to describe patient-reported outcomes, and haematological and iron parameters. Women with a postpartum haemorrhage exceeding 1000 ml and an Hb between 5·6 and 8·1 g/dl were randomized to 1500 mg of intravenous iron (n = 7) isomaltoside or RBC transfusion (n = 6). Participants completed the Multidimensional Fatigue Inventory and Edinburgh Postnatal Depression Scale, and blood samples were drawn at inclusion, daily during the first week and at weeks 3, 8 and 12. We screened 162 women and included 13 (8%). There was no significant difference between groups in fatigue or depression scores. RBC transfusion was associated with a higher Hb on day 1, inhibition of reticulocytosis during the first week and low iron levels. Intravenous iron was associated with increased reticulocytosis during the first week, repleted iron stores and a higher Hb in weeks 3-12. This pilot study shows that intravenous iron could be an attractive alternative to RBC transfusion in severe postpartum anaemia, and that a larger trial is needed and feasible. © 2016 The Authors. Vox Sanguinis published by John Wiley & Sons Ltd on behalf of International Society of Blood Transfusion.

The Impact of a Computer-Mediated Shadowing Activity on ESL Speaking Skill Development: A Pilot Study

Science.gov (United States)

Mishima, Masakazu; Cheng, Lixia

2017-01-01

This pilot study explored the instructional value and potential of a computer-mediated shadowing activity for improving English as a Second Language (ESL) learners' speech intelligibility. Prospective International Teaching Assistants (ITAs), who were enrolled in an ESL classroom communication class at a large public university, completed a…

Pilot Implementations

DEFF Research Database (Denmark)

Manikas, Maria Ie

by conducting a literature review. The concept of pilot implementation, although commonly used in practice, is rather disregarded in research. In the literature, pilot implementations are mainly treated as secondary to the learning outcomes and are presented as merely a means to acquire knowledge about a given...... objective. The prevalent understanding is that pilot implementations are an ISD technique that extends prototyping from the lab and into test during real use. Another perception is that pilot implementations are a project multiple of co-existing enactments of the pilot implementation. From this perspective......This PhD dissertation engages in the study of pilot (system) implementation. In the field of information systems, pilot implementations are commissioned as a way to learn from real use of a pilot system with real data, by real users during an information systems development (ISD) project and before...

Pilot study of once-daily simplification therapy with abacavir/lamivudine/zidovudine and efavirenz for treatment of HIV-1 infection.

Science.gov (United States)

Ruane, Peter; Lang, Joseph; DeJesus, Edwin; Berger, Daniel S; Dretler, Robin; Rodriguez, Allan; Ward, Douglas J; Lim, Michael L; Liao, Qiming; Reddy, Sunila; Clair, Marty St; Vila, Tania; Shaefer, Mark S

2006-01-01

The purpose of this pilot study was to explore the efficacy and safety of the abacavir/lamivudine/zidovudine fixed-dose combination tablet administered as two tablets once daily (qd) versus one tablet twice daily (bid) in combination with efavirenz (EFV). This was a prospective, randomized, open-label, multicenter study with a 24-week treatment period in 7 outpatient HIV clinics in the United States. Patients currently receiving an initial regimen of abacavir/lamivudine/zidovudine bid plus EFV qd for at least 6 months with HIV-1 RNA or = 200 cells/mm3 were eligible. Thirty-six patients enrolled, and 35 (97%) completed the study. Participants were randomized to switch to 2 tablets of abacavir/lamivudine/zidovudine qd plus EFV qd (QD arm) or continue current treatment (BID arm) for 24 weeks. Efficacy, safety, and adherence were evaluated. Median baseline CD4+ cell count was 521 cells/mm3. At week 24, HIV-1 RNA or = 0.29 to +0.18, p = 1.000). At week 24, median CD4+ cell count change from baseline was +26 cells/mm3 for the QD arm and -39 cells/mm3 for BID arm. One patient randomized to the QD arm met virologic failure criteria (confirmed HIV-1 RNA >120 copies/mL) at week 20 and viral genotype showed M184V. After failure, this patient revealed he never took EFV throughout the entire study after randomization, effectively receiving only abacavir/lamivudine/zidovudine qd alone. Median adherence was slightly higher in the QD arm, although both arms had broad variability and overlapping interquartile ranges. Adverse events were infrequent and occurred with similar frequency between arms; treatment-related adverse events were abdominal pain, flatulence, nausea, headache, and abnormal dreams (1 patient [3%] for each adverse event). No patients withdrew due to adverse events, and no abacavir hypersensitivity reactions were reported. In this pilot study of patients suppressed on abacavir/lamivudine/zidovudine bid plus EFV, 94% of participants switching to abacavir

Use of ready-made insoles in the treatment of lesser metatarsalgia: a prospective randomized controlled trial.

Science.gov (United States)

Kelly, A; Winson, I

1998-04-01

Two insoles designed to treat primary lesser metatarsalgia were compared in terms of their effect on plantar pressures and the subjective symptom relief. A prospective single blind randomized trial of 8 weeks' treatment in 46 feet in 33 patients was performed. Subjective outcome measures were visual analogue pain scores and estimated compliance. Objective outcome measures were dynamic plantar pressures using the Musgrave Footprint System. In group 1 (Viscoped), 6 of 18 patients rated themselves much improved or somewhat improved, and in group 2 (Langer) the proportion was 12 of 15 (P = 0.02). Reported mean compliance was 16% higher in the Langer group. Plantar forefoot pressure was lowered by the insoles in all cases. The reduction was significantly greater (P < 0.001) in group 2, both in absolute pressure and as a percentage of initial pressure. Group 2 (Langer) was significantly better in terms of reduction of peak metatarsal pressure. All the subjective outcome measures were better for the group 2 (Langer).

Efficacy of an educational manual for childbirth companions: pilot study of a randomized clinical trial

Directory of Open Access Journals (Sweden)

Liana Mara Rocha Teles

2018-05-01

Full Text Available ABSTRACT Objective: to evaluate the effectiveness of an educational manual in the instrumentalization of companions to provide support to the parturients and check its influence on the satisfaction of companions and women during vaginal delivery. Method: pilot study of a randomized controlled clinical trial with 65 companions and puerperal women (intervention = 21 and control = 44. The previous knowledge of the companions was evaluated at baseline. The Evaluation Form for Companions in the Delivery Room was used to measure the actions provided and the satisfaction with the experience, and the Questionnaire for Evaluation of the Experience and Satisfaction of Puerperal Women with Labor and Delivery was used to evaluate the satisfaction of women with childbirth. The Student’s t-test or Wilcoxon, chi-square or Fisher’s exact test, risk ratios and 95% confidence intervals were used. Results: the companions in the intervention group performed a greater number of support actions (7.2 vs 4.6, p: 0.001 and had higher satisfaction scores (72.4 vs 64.2; p = 0.00. Puerperal women in the intervention group had higher satisfaction with childbirth (119.6 vs 107.9; p: 0.000. Conclusion: the manual was effective for the instrumentalization of companions, contributed to support actions to the parturients and had repercussions on the satisfaction of companions and women with the birthing process. RBR-776d9s

[Do double gloves protect against contamination during cannulation of blood vessels? A prospective randomized study].

Science.gov (United States)

Szarpak, Łukasz; Kurowski, Andrzej

2014-01-01

Undamaged medical gloves protect medical personnel from contact with physiological fluids of the patient. Thus they protect the assistance provider from hand skin contamination with potentially infectious biological materials. The aim of the study was to evaluate the occurrence of pierce, perforations or damage of medical gloves during cannulation of blood vessels. In the prospective randomized study 303 pairs of gloves, used during cannulation of blood vessels under simulated resuscitation, were analyzed. Gloves were tested by the water leak test. The water test revealed 44 cases of damage to the gloves used during cannulation of blood vessels. Significant differences were noted in the frequency of damage to both the outer and single pairs of gloves and the inner pair of gloves. The study showed that the use of double gloves provides a higher level of security for a paramedic than the use of a single pair of gloves, however, double gloves reduce the manual dexterity of a paramedic. A large number of damages to gloves are not noticed by medical personnel during surgery.

A Randomized Controlled Pilot Intervention Study of a Mindfulness-Based Self-Leadership Training (MBSLT) on Stress and Performance.

Science.gov (United States)

Sampl, Juliane; Maran, Thomas; Furtner, Marco R

2017-01-01

The present randomized pilot intervention study examines the effects of a mindfulness-based self-leadership training (MBSLT) specifically developed for academic achievement situations. Both mindfulness and self-leadership have a strong self-regulatory focus and are helpful in terms of stress resilience and performance enhancements. Based on several theoretical points of contact and a specific interplay between mindfulness and self-leadership, the authors developed an innovative intervention program that improves mood as well as performance in a real academic setting. The intervention was conducted as a randomized controlled study over 10 weeks. The purpose was to analyze the effects on perceived stress, test anxiety, academic self-efficacy, and the performance of students by comparing an intervention and control group ( n  = 109). Findings demonstrated significant effects on mindfulness, self-leadership, academic self-efficacy, and academic performance improvements in the intervention group. Results showed that the intervention group reached significantly better grade point averages than the control group. Moreover, the MBSLT over time led to a reduction of test anxiety in the intervention group compared to the control group. Furthermore, while participants of the control group showed an increase in stress over time, participants of the intervention group maintained constant stress levels over time. The combination of mindfulness and self-leadership addressed both positive effects on moods and on objective academic performance. The effects demonstrate the great potential of combining mindfulness with self-leadership to develop a healthy self-regulatory way of attaining achievement-related goals and succeeding in high-stress academic environments.

Posterior lumbar interbody fusion using nonresorbable poly-ether-ether-ketone versus resorbable poly-L-lactide-co-D,L-lactide fusion devices: a prospective, randomized study to assess fusion and clinical outcome

NARCIS (Netherlands)

Jiya, T.U.; Smit, T.H.; Deddens, J.; Mullender, M.G.

2009-01-01

STUDY DESIGN: A prospective randomized clinical study. OBJECTIVE.: To assess fusion, clinical outcome, and complications. SUMMARY OF BACKGROUND DATA: Resorbable poly-L- lactide-co-D,L-lactide (PLDLLA) cages intended to aid spinal interbody fusion have been introduced into clinical practice within

Neuroimaging Correlates of Post-Stroke Aphasia Rehabilitation in a Pilot Randomized Trial of Constraint-Induced Aphasia Therapy.

Science.gov (United States)

Nenert, Rodolphe; Allendorfer, Jane B; Martin, Amber M; Banks, Christi; Ball, Angel; Vannest, Jennifer; Dietz, Aimee R; Szaflarski, Jerzy P

2017-07-18

BACKGROUND Recovery from post-stroke aphasia is a long and complex process with an uncertain outcome. Various interventions have been proposed to augment the recovery, including constraint-induced aphasia therapy (CIAT). CIAT has been applied to patients suffering from post-stroke aphasia in several unblinded studies to show mild-to-moderate linguistic gains. The aim of the present study was to evaluate the neuroimaging correlates of CIAT in patients with chronic aphasia related to left middle cerebral artery stroke. MATERIAL AND METHODS Out of 24 patients recruited in a pilot randomized blinded trial of CIAT, 19 patients received fMRI of language. Eleven of them received CIAT (trained) and eight served as a control group (untrained). Each patient participated in three fMRI sessions (before training, after training, and 3 months later) that included semantic decision and verb generation fMRI tasks, and a battery of language tests. Matching healthy control participants were also included (N=38; matching based on age, handedness, and sex). RESULTS Language testing showed significantly improved performance on Boston Naming Test (BNT; paphasia with no specific effect from CIAT training.

Results of a randomized controlled pilot trial of intravascular renal denervation for management of treatment-resistant hypertension.

Science.gov (United States)

Jacobs, Lotte; Persu, Alexandre; Huang, Qi-Fang; Lengelé, Jean-Philippe; Thijs, Lutgarde; Hammer, Frank; Yang, Wen-Yi; Zhang, Zhen-Yu; Renkin, Jean; Sinnaeve, Peter; Wei, Fang-Fei; Pasquet, Agnès; Fadl Elmula, Fadl Elmula M; Carlier, Marc; Elvan, Arif; Wunder, Cora; Kjeldsen, Sverre E; Toennes, Stefan W; Janssens, Stefan; Verhamme, Peter; Staessen, Jan A

2017-12-01

Previous trials of catheter-based renal-artery denervation (RDN) as treatment modality in resistant hypertension (rHT) generated unconvincing results. In the Investigator-Steered Project on Intravascular Denervation for Management of Treatment-Resistant Hypertension (INSPiRED; NCT01505010), we optimized selection and management of rHT patients. With ethical clearance to randomize 18 patients, three Belgian hypertension centers screened 29 rHT patients on treatment with ≥3 drugs, of whom 17 after optimization of treatment (age efficacy endpoint, and 2.5 mL/min/1.73 m 2 (+1.5 vs. -1.1 mL/min/1.73 m 2 ; P = .86) for eGFR, the primary safety endpoint. At 6 month, ECG voltages and the number of prescribed drugs (P ≤ .036) were lower in RDN patients, but quality of life and adherence, captured by questionnaire and urine analysis were similar in both groups. Changes in BP and adherence were unrelated. No major complications occurred. The INSPiRED pilot suggests that RDN with the EnligHTN ™ system is effective and safe and generated insights useful for the design of future RDN trials.

Effects of the addition of transcranial direct current stimulation to virtual reality therapy after stroke: a pilot randomized controlled trial.

Science.gov (United States)

Viana, R T; Laurentino, G E C; Souza, R J P; Fonseca, J B; Silva Filho, E M; Dias, S N; Teixeira-Salmela, L F; Monte-Silva, K K

2014-01-01

Upper limb (UL) impairment is the most common disabling deficit following a stroke. Previous studies have suggested that transcranial direct current stimulation (tDCS) enhances the effect of conventional therapies. This pilot double-blind randomized control trial aimed to determine whether or not tDCS, combined with Wii virtual reality therapy (VRT), would be superior to Wii therapy alone in improving upper limb function and quality of life in chronic stroke individuals. Twenty participants were randomly assigned either to an experimental group that received VRT and tDCS, or a control group that received VRT and sham tDCS. The therapy was delivered over 15 sessions with 13 minutes of active or sham anodal tDCS, and one hour of virtual reality therapy. The outcomes included were determined using the Fugl-Meyer scale, the Wolf motor function test, the modified Ashworth scale (MAS), grip strength, and the stroke specific quality of life scale (SSQOL). Minimal clinically important differences (MCID) were observed when assessing outcome data. Both groups demonstrated gains in all evaluated areas, except for the SSQOL-UL domain. Differences between groups were only observed in wrist spasticity levels in the experimental group, where more than 50% of the participants achieved the MCID. These findings support that tDCS, combined with VRT therapy, should be investigated and clarified further.

Milrinone therapy for enterovirus 71-induced pulmonary edema and/or neurogenic shock in children: a randomized controlled trial.

Science.gov (United States)

Chi, Chia-Yu; Khanh, Truong Huu; Thoa, Le Phan Kim; Tseng, Fan-Chen; Wang, Shih-Min; Thinh, Le Quoc; Lin, Chia-Chun; Wu, Han-Chieh; Wang, Jen-Ren; Hung, Nguyen Thanh; Thuong, Tang Chi; Chang, Chung-Ming; Su, Ih-Jen; Liu, Ching-Chuan

2013-07-01

Enterovirus 71-induced brainstem encephalitis with pulmonary edema and/or neurogenic shock (stage 3B) is associated with rapid mortality in children. In a small pilot study, we found that milrinone reduced early mortality compared with historical controls. This prospective, randomized control trial was designed to provide more definitive evidence of the ability of milrinone to reduce the 1-week mortality of stage 3B enterovirus 71 infections. Prospective, unicenter, open-label, randomized, controlled study. Inpatient ward of a large tertiary teaching hospital in Ho Chi Minh City, Vietnam. Children (≤ 18 yr old) admitted with proven enterovirus 71-induced pulmonary edema and/or neurogenic shock. Patients were randomly assigned to receive intravenous milrinone (0.5 μg/kg/min) (n = 22) or conventional management (n = 19). Both groups received dopamine or dobutamine and intravenous immunoglobulin. The primary endpoint was 1-week mortality. The secondary endpoints included length of ventilator dependence and hospital stay and adverse events. The median age was 2 years with a predominance of boys in both groups. The 1-week mortality was significantly lower, 18.2% (4/22) in the milrinone compared with 57.9% (11/19) in the conventional management group (relative risk = 0.314 [95% CI, 0.12-0.83], p = 0.01). The median duration of ventilator-free days was longer in the milrinone treatment group (p = 0.01). There was no apparent neurologic sequela in the survivors in either group, and no drug-related adverse events were documented. Milrinone significantly reduced the 1-week mortality of enterovirus 71-induced pulmonary edema and/or neurogenic shock without adverse effects. Further studies are needed to determine whether milrinone might be useful to prevent progression of earlier stages of brainstem encephalitis.

76 FR 54095 - Pilot in Command Proficiency Check and Other Changes to the Pilot and Pilot School Certification...

Science.gov (United States)

2011-08-31

... [Docket No.: FAA-2008-0938; Amendment Nos. 61-128, 91-324, 141-15, and 142-7] RIN 2120-AJ18 Pilot in Command Proficiency Check and Other Changes to the Pilot and Pilot School Certification Rules AGENCY... regulations concerning pilot, flight instructor, and pilot school certification. This rule will require pilot...

YAG laser peripheral iridotomy for the prevention of pigment dispersion glaucoma a prospective, randomized, controlled trial.

Science.gov (United States)

Scott, Andrew; Kotecha, Aachal; Bunce, Catey; Balidis, Miltos; Garway-Heath, David F; Miller, Michael H; Wormald, Richard

2011-03-01

To test the hypothesis that neodymium:yttrium-aluminum-garnet (Nd:YAG) laser peripheral iridotomy (LPI) significantly reduces the incidence of conversion from pigment dispersion syndrome (PDS) with ocular hypertension (OHT) to pigmentary glaucoma (PG). Prospective, randomized, controlled 3-year trial. One hundred sixteen eyes of 116 patients with PDS and OHT. Patients were assigned randomly either to Nd:YAG LPI or to a control group (no laser). The primary outcome measure was conversion to PG within 3 years, based on full-threshold visual field (VF) analysis using the Ocular Hypertension Treatment Study criteria. Secondary outcome measures were whether eyes required topical antiglaucoma medications during the study period and the time to conversion or medication. Fifty-seven patients were randomized to undergo laser treatment and 59 were randomized to no laser (controls). Age, gender, spherical equivalent refraction, and intraocular pressure at baseline were similar between groups. Outcome data were available for 105 (90%) of recruited subjects, 52 in the laser treatment group and 53 in the no laser treatment group. Patients were followed up for a median of 35.9 months (range, 10-36 months) in the laser arm and 35.9 months (range, 1-36 months) in the control arm. Eight eyes (15%) in the laser group and 3 eyes (6%) in the control group converted to glaucoma in the study period. The proportion of eyes started on medical treatment was similar in the 2 groups: 8 eyes (15%) in the laser group and 9 eyes (17%) in the control group. Survival analyses showed no evidence of any difference in time to VF progression or commencement of topical therapy between the 2 groups. Cataract extraction was performed on 1 patient in the laser group and in 1 patient in the control group during the study period (laser eye at 18 months; control eye at 34 months). This study suggests that there was no benefit of Nd:YAG LPI in preventing progression from PDS with OHT to PG within 3 years of

Procedures for assessing psychological predictors of injuries in circus artists: a pilot prospective study.

Science.gov (United States)

Shrier, Ian; Raglin, John S; Levitan, Emily B; Mittleman, Murray A; Steele, Russell J; Powell, Janette

2014-06-11

Research on psychological risk factors for injury has focused on stable traits. Our objective was to test the feasibility of a prospective longitudinal study designed to examine labile psychological states as risk factors of injury. We measured psychological traits at baseline (mood, ways of coping and anxiety), and psychological states every day (1-item questions on anxiety, sleep, fatigue, soreness, self-confidence) before performances in Cirque du Soleil artists of the show "O". Additional questions were added once per week to better assess anxiety (20-item) and mood. Questionnaires were provided in English, French, Russian and Japanese. Injury and exposure data were extracted from electronic records that are kept as part of routine business practices. The 43.9% (36/82) recruitment rate was more than expected. Most artists completed the baseline questionnaires in 15 min, a weekly questionnaire in <2 min and a daily questionnaire in <1 min. We improved the formatting of some questions during the study, and adapted the wording of other questions to improve clarity. There were no dropouts during the entire study, suggesting the questionnaires were appropriate in content and length. Results for sample size calculations depend on the number of artists followed and the minimal important difference in injury rates, but in general, preclude a purely prospective study with daily data collection because of the long follow-up required. However, a prospective nested case-crossover design with data collection bi-weekly and at the time of injury appears feasible. A prospective study collecting psychological state data from subjects who train and work regularly together is feasible, but sample size calculations suggest that the optimal study design would use prospective nested case-crossover methodology.

Stenting or not prior to extracorporeal shockwave lithotripsy for ureteral stones? Results of a prospective randomized study.

Science.gov (United States)

Sfoungaristos, Stavros; Polimeros, Nikolaos; Kavouras, Adamantios; Perimenis, Petros

2012-06-01

To determine the need for pre-treatment stenting in patients undergoing extracorporeal shockwave lithotripsy (ESWL) for ureteral stones sized 4-10 mm. A prospective randomized study was conducted between September 2009 and March 2011. Included 156 patients randomized in stented and non-stented groups and underwent a maximum of 3 ESWL sessions. Radiographic follow-up was used to assess the stone fragmentation and clearance. Results were compared in terms of stone-free rates, post-treatment morbidity and complications. Overall efficacy was 76.9%. Stone-free rates were statistically significantly lower (P = 0.026) in the stented group (68.6%) compared to the non-stented ones (83.7%). Furthermore, stenting was significantly correlated with post-treatment lower urinary tract symptoms (P ≤ 0.001), need for more ESWL sessions (P = 0.019) and possibility for operation due to ESWL failure (P = 0.026). A multivariate analysis was conducted to identify the parameters which may predict complete stone removal after ESWL. Stone size (P = 0.026), stone location (P = 0.011) and stenting (P = 0.007) were the most significant factors. ESWL is an efficient and safe treatment for 4- to 10-mm ureteral stones. Pre-treatment stenting is limiting stone-free rates and is significantly influencing post-ESWL morbidity and quality of life in a negative manner, while it contributes minimally to the prophylaxis of complications.

Improving Post-Discharge Medication Adherence in Patients with CVD: A Pilot Randomized Trial

Directory of Open Access Journals (Sweden)

Alfredo D. Oliveira-Filho

2014-12-01

Full Text Available Background: Effective interventions to improve medication adherence are usually complex and expensive. Objective: To assess the impact of a low-cost intervention designed to improve medication adherence and clinical outcomes in post-discharge patients with CVD. Method: A pilot RCT was conducted at a teaching hospital. Intervention was based on the four-item Morisky Medication Adherence Scale (MMAS-4. The primary outcome measure was medication adherence assessed using the eight-item MMAS at baseline, at 1 month post hospital discharge and re-assessed 1 year after hospital discharge. Other outcomes included readmission and mortality rates. Results: 61 patients were randomized to intervention (n = 30 and control (n = 31 groups. The mean age of the patients was 61 years (SD 12.73, 52.5% were males, and 57.4% were married or living with a partner. Mean number of prescribed medications per patient was 4.5 (SD 3.3. Medication adherence was correlated to intervention (p = 0.04 and after 1 month, 48.4% of patients in the control group and 83.3% in the intervention group were considered adherent. However, this difference decreased after 1 year, when adherence was 34.8% and 60.9%, respectively. Readmission and mortality rates were related to low adherence in both groups. Conclusion: The intervention based on a validated patient self-report instrument for assessing adherence is a potentially effective method to improve adherent behavior and can be successfully used as a tool to guide adherence counseling in the clinical visit. However, a larger study is required to assess the real impact of intervention on these outcomes.

Randomized controlled expressive writing pilot in individuals with Parkinson's disease and their caregivers.

Science.gov (United States)

Cash, Therese Verkerke; Lageman, Sarah K

2015-11-30

Individuals with Parkinson's disease (PD) and their caregivers are at risk for emotional distress and hypercortisolism. Expressive writing is an effective complementary intervention to ameliorate the psychological and physiological effects of chronic illness. This pilot study aimed to evaluate feasibility and preliminary effectiveness of an expressive writing intervention for individuals with PD and their caregivers. Individuals with PD (N = 27) and their caregivers (N = 14) were randomly assigned to expressive (N = 15 patients, eight caregivers) or neutral (N = 12 patients, six caregivers) writing conditions. Cortisol awakening response (CAR), non-motor functioning, quality of life, and performance on tests of cognitive functioning were assessed at baseline, immediate post, 4-month, and 10-month post intervention. Attrition was a challenge as eight patients (29.62 %) and four caregivers (28.57 %) chose to discontinue before beginning the intervention or were lost to follow up prior to completing the intervention or the first follow up visit. Significant reduction in anxiety, marginally significant improvement in depression and caregiver burden, and significant improvements in performance on tests of learning and memory were observed, but these changes did not differ by writing condition. CAR significantly differed over time between patients and caregivers and writing conditions. Some evidence for the feasibility and effectiveness of writing to alleviate hypercortisolism was demonstrated in a small sample of PD patients; however, relatively high attrition rates and the lack of difference between expressive and neutral writing conditions on emotional and neurocognitive outcomes suggests expressive writing procedure modifications may be needed to obtain optimal results for this population. ClinicalTrials.gov, NCT02217735 , Study Start Date: August 30, 2011.

Procalcitonin guided antibiotic therapy and hospitalization in patients with lower respiratory tract infections: a prospective, multicenter, randomized controlled trial

Directory of Open Access Journals (Sweden)

Henzen Christoph

2007-07-01

Full Text Available Abstract Background: Lower respiratory tract infections like acute bronchitis, exacerbated chronic obstructive pulmonary disease and community-acquired pneumonia are often unnecessarily treated with antibiotics, mainly because of physicians' difficulties to distinguish viral from bacterial cause and to estimate disease-severity. The goal of this trial is to compare medical outcomes, use of antibiotics and hospital resources in a strategy based on enforced evidence-based guidelines versus procalcitonin guided antibiotic therapy in patients with lower respiratory tract infections. Methods and design: We describe a prospective randomized controlled non-inferiority trial with an open intervention. We aim to randomize over a fixed recruitment period of 18 months a minimal number of 1002 patients from 6 hospitals in Switzerland. Patients must be >18 years of age with a lower respiratory tract infections Discussion: Use of and prolonged exposure to antibiotics in lower respiratory tract infections is high. The proposed trial investigates whether procalcitonin-guidance may safely reduce antibiotic consumption along with reductions in hospitalization costs and antibiotic resistance. It will additionally generate insights for improved prognostic assessment of patients with lower respiratory tract infections. Trial registration: ISRCTN95122877

Cognitive and physical rehabilitation of intensive care unit survivors: results of the RETURN randomized controlled pilot investigation.

Science.gov (United States)

Jackson, James C; Ely, E Wesley; Morey, Miriam C; Anderson, Venice M; Denne, Laural B; Clune, Jennifer; Siebert, Carol S; Archer, Kristin R; Torres, Renee; Janz, David; Schiro, Elena; Jones, Julie; Shintani, Ayumi K; Levine, Brian; Pun, Brenda T; Thompson, Jennifer; Brummel, Nathan E; Hoenig, Helen

2012-04-01

Millions of patients who survive medical and surgical general intensive care unit care every year experience newly acquired long-term cognitive impairment and profound physical and functional disabilities. To overcome the current reality in which patients receive inadequate rehabilitation, we devised a multifaceted, in-home, telerehabilitation program implemented using social workers and psychology technicians with the goal of improving cognitive and functional outcomes. This was a single-site, feasibility, pilot, randomized trial of 21 general medical/surgical intensive care unit survivors (8 controls and 13 intervention patients) with either cognitive or functional impairment at hospital discharge. After discharge, study controls received usual care (sporadic rehabilitation), whereas intervention patients received a combination of in-home cognitive, physical, and functional rehabilitation over a 3-month period via a social worker or master's level psychology technician utilizing telemedicine to allow specialized multidisciplinary treatment. Interventions over 12 wks included six in-person visits for cognitive rehabilitation and six televisits for physical/functional rehabilitation. Outcomes were measured at the completion of the rehabilitation program (i.e., at 3 months), with cognitive functioning as the primary outcome. Analyses were conducted using linear regression to examine differences in 3-month outcomes between treatment groups while adjusting for baseline scores. Patients tolerated the program with only one adverse event reported. At baseline both groups were well-matched. At 3-month follow-up, intervention group patients demonstrated significantly improved cognitive executive functioning on the widely used and well-normed Tower test (for planning and strategic thinking) vs. controls (median [interquartile range], 13.0 [11.5-14.0] vs. 7.5 [4.0-8.5]; adjusted p improving cognitive performance and functional outcomes in just 3 months. Future investigations

Optimal scheme of postoperative chemoradiotherapy in rectal cancer: phase III prospective randomized trial

International Nuclear Information System (INIS)

Kim, Young Seok; Kim, Jong Hoon; Choi, Eun Kyung

2002-01-01

To determine the optimal scheme of postoperative chemoradiotherapy in rectal cancer by comparing survival, patterns of failure, toxicities in early and late radiotherapy groups using a phase III randomized prospective clinical trial. From January 1996 to March 1999, 307 patients with curatively resected AJCC stage II and III rectal cancer were assigned randomly to an 'early (151 patients, arm I)' or a 'late (156 patients, arm II)' and were administered combined chemotherapy (5-FU 375 mg/m 2 /day, leucovorin 20 mg/m 2 , IV bolus daily, for 3 days with RT, 5 days without RT, 8 cycles with 4 weeks interval) and radiation therapy (whole pelvis with 45 Gy/25 fractions/5 weeks). Patients of arm I received radiation therapy from day 1 of the first cycle of chemotherapy and those of arm II from day 57 with a third cycle of chemotherapy. The median follow-up period of living patients was 40 months. Of the 307 patients enrolled, fifty patients did not receive scheduled radiation therapy or chemotherapy. The overall survival rate and disease free survival rate at 5 years were 78.3% and 68.7% in arm I, and 78.4% and 67.5% in arm II. The local recurrence rate was 6.6% and 6.4% (ρ = 0.46) in arms I and II, respectively, no significant difference was observed between the distant metastasis rates of the two arms (23.8% and 29.5%, ρ = 0.16). During radiation therapy, grade 3 diarrhea or more, by the NCI common toxicity criteria, was observed in 63.0% and 58.2% of the respective arms (ρ = N.S.), but most were controlled with supportive care. Hematologic toxicity (leukopenia) greater than RTOG grade 2 was found in only 1.3% and 2.6% of patients in each respective arm. There was no significant difference in survival, patterns of failure or toxicities between the early and late radiation therapy arms. Postoperative adjuvant chemoradiation was found to be a relatively safe treatment but higher compliance is needed

Design, rationale, and baseline demographics of SEARCH I: a prospective cluster-randomized study

Directory of Open Access Journals (Sweden)

Albers F

2012-07-01

Full Text Available Frank Albers,1 Asif Shaikh,2 Ahmar Iqbal,31Medical Affairs Respiratory, 2Clinical Development and Medical Affairs, Field Based Medicine-Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA; 3Respiratory Medical Affairs, Pfizer Inc, New York, NY, USAAbstract: Questionnaires are available to identify patients at risk for several chronic diseases, including COPD, but are infrequently utilized in primary care. COPD is often underdiagnosed, while at the same time the US Preventive Services Task Force recommends against spirometric screening for COPD in asymptomatic adults. Use of a symptom-based questionnaire and subsequent handheld spirometric device depending on the answers to the questionnaire is a promising approach to identify patients at risk for COPD. Screening, Evaluating and Assessing Rate CHanges of diagnosing respiratory conditions in primary care 1 (SEARCH I was a prospective cluster-randomized study in 168 US primary care practices evaluating the effect of the COPD-Population Screener (COPD-PS™ questionnaire. The effect of this questionnaire alone or sequentially with the handheld copd-6TM device was evaluated on new diagnoses of COPD and on respiratory diagnostic practice patterns (including referrals for pulmonary function testing, referrals to pulmonologists, new diagnoses of COPD, and new respiratory medication prescriptions. Participating practices entered a total of 9704 consecutive consenting subjects aged ≥ 40 years attending primary care clinics. Study arm results were compared for new COPD diagnosis rates between usual care and (1 COPD-PS plus copd-6 and (2 COPD-PS alone. A cluster-randomization design allowed comparison of the intervention effects at the practice level instead of individuals being the subjects of the intervention. Regional principal investigators controlled the flow of study information to sub-investigators at participating practices to reduce observation bias (Hawthorne effect. The

Thymoglobulin induction in liver transplant recipients with a tacrolimus, mycophenolate mofetil, and steroid immunosuppressive regimen: a five-year randomized prospective study.

Science.gov (United States)

Boillot, Olivier; Seket, Belhassen; Dumortier, Jérôme; Pittau, Gabriella; Boucaud, Catherine; Bouffard, Yves; Scoazec, Jean-Yves

2009-11-01

This randomized, comparative study assessed the long-term efficacy and tolerability of thymoglobulin (TMG) induction in 93 liver transplant patients with an initial regimen of tacrolimus (Tac), mycophenolate mofetil (MMF), and steroids. Forty-four patients were randomly allocated to the TMG+ group, and 49 patients were randomly allocated to the TMG- group. In both groups, Tac was given orally at the initial daily dose of 0.075 mg/kg twice daily, and MMF was given at the initial daily dose of 2 g/day. Steroid withdrawal was planned at 3 months after liver transplantation. The results were evaluated with respect to acute rejection incidence, patient and graft survival, graft function, and medical complications until 5 years or death for all patients. No significant differences were found between groups for the incidence of acute rejection at 5 years (11.4% versus 14.3%), 5-year patient survival (77.3% versus 87.8%), graft function, or postoperative renal function. One patient in the TMG- group underwent retransplantation. There was no difference between groups with respect to the incidence of medical complications, excepted for a higher rate of leukopenia in the TMG+ group, during the 5-year follow-up. In conclusion, the results of this prospective randomized study suggest that the addition of TMG to a triple immunosuppressive regimen (Tac, MMF, and steroids) did not modify the incidence of acute rejection episodes or long-term survival and was responsible for increased leukopenia rates.

Brief report: pulmonary auscultation in the operating room: a prospective randomized blinded trial comparing electronic and conventional stethoscopes.

Science.gov (United States)

Hoffmann, Clement; Falzone, Elisabeth; Verret, Catherine; Pasquier, Pierre; Leclerc, Thomas; Donat, Nicolas; Jost, Daniel; Mérat, Stephane; Maurice, Guillaume de Saint; Lenoir, Bernard; Auroy, Yves; Tourtier, Jean-Pierre

2013-09-01

We compared the subjective quality of pulmonary auscultation between 2 acoustic stethoscopes (Holtex Ideal® and Littmann Cardiology III®) and an electronic stethoscope (Littmann 3200®) in the operating room. A prospective double-blind randomized study with an evaluation during mechanical ventilation was performed in 100 patients. After each examination, the listeners using a numeric scale (0-10) rated the quality of auscultation. Auscultation quality was compared in patients among stethoscopes with a multilevel mixed-effects linear regression with random intercept (operator effect), adjusted on significant factors in univariate analysis. A significant difference was defined as P auscultation were performed. The quality of auscultation was rated 8.2 ± 1.6 for the electronic stethoscope, 7.4 ± 1.8 for the Littmann Cardiology III, and 4.6 ± 1.8 for the Holtex Ideal. Compared with Holtex Ideal, auscultation quality was significantly higher with other stethoscopes (P auscultation quality was significantly higher with Littmann 3200 electronic stethoscope (β = 0.9 [95% confidence interval, 0.5-1.3]). An electronic stethoscope can provide a better quality of pulmonary auscultation than acoustic stethoscopes in the operating room, yet with a magnitude of improvement marginally higher than that provided with a high performance acoustic stethoscope. Whether this can translate into a clinically relevant benefit requires further studies.

PONV in Ambulatory surgery: A comparison between Ramosetron and Ondansetron: a prospective, double-blinded, and randomized controlled study

Directory of Open Access Journals (Sweden)

Debasis Banerjee

2014-01-01

Full Text Available Background: postoperative nausea and vomiting (PONV frequently hampers implementation of ambulatory surgery in spite of so many antiemetic drugs and regimens. Aims: the study was carried out to compare the efficacy of Ramosetron and Ondansetron in preventing PONV after ambulatory surgery. Setting and Design: it was a prospective, double blinded, and randomized controlled study. Methods: 124 adult patients of either sex, aged 25-55, of ASA physical status I and II, scheduled for day care surgery, were randomly allocated into Group A [(n=62 receiving (IV Ondansetron (4 mg] and Group B [(n=62 receiving IV Ramosetron (0.3 mg] prior to the induction of general anesthesia in a double-blind manner. Episodes of PONV were noted at 0.5, 1, 2, 4 h, 6 , 12, and 18 h postoperatively. Statistical Analysis and Results: statistically significant difference between Groups A and B (P <0.05 was found showing that Ramosetron was superior to Ondansetron as antiemetic both regarding frequency and severity. Conclusion: it was evident that preoperative prophylactic administration of single dose IV Ramosetron (0.3 mg has better efficacy than single dose IV Ondansetron (4 mg in reducing the episodes of PONV over 18 h postoperatively in patients undergoing day-care surgery under general anesthesia.

Increasing Performance of Professional Soccer Players and Elite Track and Field Athletes with Peak Performance Training and Biofeedback: A Pilot Study

OpenAIRE

Rijken, Noortje H.; Soer, Remko; de Maar, Ewold; Prins, Hilco; Teeuw, Wouter B.; Peuscher, Jan; Oosterveld, Frits G. J.

2016-01-01

The aim of this pilot study was to investigate the effects of an intervention consisting of mental coaching combined with either electro encephalogram (EEG) alpha power feedback or heart rate variability (HRV) feedback on HRV, EEG outcomes and self-reported factors related to stress, performance, recovery and sleep quality in elite athletes. A prospective pilot study was performed with two distinct cohorts. Soccer players were provided with four sessions of mental coaching combined with daily...

Effect of Alternate Nostril Breathing Exercise on Experimentally Induced Anxiety in Healthy Volunteers Using the Simulated Public Speaking Model: A Randomized Controlled Pilot Study.

Science.gov (United States)

Kamath, Ashwin; Urval, Rathnakar P; Shenoy, Ashok K

2017-01-01

A randomized controlled pilot study was carried out to determine the effect of a 15-minute practice of ANB exercise on experimentally induced anxiety using the simulated public speaking model in yoga-naïve healthy young adults. Thirty consenting medical students were equally divided into test and control groups. The test group performed alternate nostril breathing exercise for 15 minutes, while the control group sat in a quiet room before participating in the simulated public speaking test (SPST). Visual Analog Mood Scale and Self-Statements during Public Speaking scale were used to measure the mood state at different phases of the SPST. The psychometric scores of both groups were comparable at baseline. Repeated-measures ANOVA showed a significant effect of phase ( p < 0.05), but group and gender did not have statistically significant influence on the mean anxiety scores. However, the test group showed a trend towards lower mean scores for the anxiety factor when compared with the control group. Considering the limitations of this pilot study and the trend seen towards lower anxiety in the test group, alternate nostril breathing may have potential anxiolytic effect in acute stressful situations. A study with larger sample size is therefore warranted. This trial is registered with CTRI/2014/03/004460.

A randomized, controlled, single-blind, 6-month pilot study to evaluate the efficacy of MS-Line!: a cognitive rehabilitation programme for patients with multiple sclerosis.

Science.gov (United States)

Gich, Jordi; Freixanet, Jordi; García, Rafael; Vilanova, Joan Carles; Genís, David; Silva, Yolanda; Montalban, Xavier; Ramió-Torrentà, Lluís

2015-09-01

MS-Line! was created to provide an effective treatment for cognitive impairment in multiple sclerosis (MS) patients. To assess the efficacy of MS-Line!. A randomized, controlled, single-blind, 6-month pilot study. Patients were randomly assigned to an experimental group (cognitive rehabilitation with the programme) or to a control group (no cognitive rehabilitation). Randomization was stratified by cognitive impairment level. Cognitive assessment included: selective reminding test, 10/36 spatial recall test (10/36 SPART), symbol digit modalities test, paced auditory serial addition test, word list generation (WLG), FAS test, subtests of WAIS-III, Boston naming test (BNT), and trail making test (TMT). Forty-three patients (22 in the experimental group, 21 in the control group) were analyzed. Covariance analysis showed significant differences in 10/36 SPART (P=0.0002), 10/36 SPART delayed recall (P=0.0021), WLG (P=0.0123), LNS (P=0.0413), BNT (P=0.0007) and TMT-A (P=0.010) scores between groups. The study showed a significant improvement related to learning and visual memory, executive functions, attention and information processing speed, and naming ability in those patients who received cognitive rehabilitation. The results suggest that MS-Line! is effective in improving cognitive impairment in MS patients. © The Author(s), 2015.

Sampling strategy for a large scale indoor radiation survey - a pilot project

International Nuclear Information System (INIS)

Strand, T.; Stranden, E.

1986-01-01

Optimisation of a stratified random sampling strategy for large scale indoor radiation surveys is discussed. It is based on the results from a small scale pilot project where variances in dose rates within different categories of houses were assessed. By selecting a predetermined precision level for the mean dose rate in a given region, the number of measurements needed can be optimised. The results of a pilot project in Norway are presented together with the development of the final sampling strategy for a planned large scale survey. (author)

A randomized, blinded, prospective clinical trial of postoperative rehabilitation in dogs after surgical decompression of acute thoracolumbar intervertebral disc herniation.

Science.gov (United States)

Zidan, Natalia; Sims, Cory; Fenn, Joe; Williams, Kim; Griffith, Emily; Early, Peter J; Mariani, Chris L; Munana, Karen R; Guevar, Julien; Olby, Natasha J

2018-05-01

Experimental evidence shows benefit of rehabilitation after spinal cord injury (SCI) but there are limited objective data on the effect of rehabilitation on recovery of dogs after surgery for acute thoracolumbar intervertebral disc herniations (TL-IVDH). Compare the effect of basic and intensive post-operative rehabilitation programs on recovery of locomotion in dogs with acute TL-IVDH in a randomized, blinded, prospective clinical trial. Thirty non-ambulatory paraparetic or paraplegic (with pain perception) dogs after decompressive surgery for TL-IVDH. Blinded, prospective clinical trial. Dogs were randomized (1:1) to a basic or intensive 14-day in-house rehabilitation protocol. Fourteen-day open field gait score (OFS) and coordination (regulatory index, RI) were primary outcomes. Secondary measures of gait, post-operative pain, and weight were compared at 14 and 42 days. Of 50 dogs assessed, 32 met inclusion criteria and 30 completed the protocol. There were no adverse events associated with rehabilitation. Median time to walking was 7.5 (2 - 37) days. Mean change in OFS by day 14 was 6.13 (confidence intervals: 4.88, 7.39, basic) versus 5.73 (4.94, 6.53, intensive) representing a treatment effect of -0.4 (-1.82, 1.02) which was not significant, P=.57. RI on day 14 was 55.13 (36.88, 73.38, basic) versus 51.65 (30.98, 72.33, intensive), a non-significant treatment effect of -3.47 (-29.81, 22.87), P = .79. There were no differences in secondary outcomes between groups. Early postoperative rehabilitation after surgery for TL-IVDH is safe but doesn't improve rate or level of recovery in dogs with incomplete SCI. Copyright © 2018 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

A training approach to improve stepping automaticity while dual-tasking in Parkinson's disease: A prospective pilot study.

Science.gov (United States)

Chomiak, Taylor; Watts, Alexander; Meyer, Nicole; Pereira, Fernando V; Hu, Bin

2017-02-01

Deficits in motor movement automaticity in Parkinson's disease (PD), especially during multitasking, are early and consistent hallmarks of cognitive function decline, which increases fall risk and reduces quality of life. This study aimed to test the feasibility and potential efficacy of a wearable sensor-enabled technological platform designed for an in-home music-contingent stepping-in-place (SIP) training program to improve step automaticity during dual-tasking (DT). This was a 4-week prospective intervention pilot study. The intervention uses a sensor system and algorithm that runs off the iPod Touch which calculates step height (SH) in real-time. These measurements were then used to trigger auditory (treatment group, music; control group, radio podcast) playback in real-time through wireless headphones upon maintenance of repeated large amplitude stepping. With small steps or shuffling, auditory playback stops, thus allowing participants to use anticipatory motor control to regain positive feedback. Eleven participants were recruited from an ongoing trial (Trial Number: ISRCTN06023392). Fear of falling (FES-I), general cognitive functioning (MoCA), self-reported freezing of gait (FOG-Q), and DT step automaticity were evaluated. While we found no significant effect of training on FES-I, MoCA, or FOG-Q, we did observe a significant group (music vs podcast) by training interaction in DT step automaticity (Ptraining to increase motor automaticity for people living with PD. The training approach described here can be implemented at home to meet the growing demand for self-management of symptoms by patients.

Impact of fumaric acid esters on cardiovascular risk factors and depression in psoriasis: a prospective pilot study.

Science.gov (United States)

Schmieder, Astrid; Poppe, Manuel; Hametner, Christian; Meyer-Schraml, Hanna; Schaarschmidt, Marthe-Lisa; Findeisen, Peter; Benoit, Sandrine; Bauer, Boris; Schmid, Sybille; Goebeler, Matthias; Goerdt, Sergij; Ludwig-Peitsch, Wiebke K

2015-07-01

Patients with psoriasis have an increased risk of cardiovascular disease that is partly attributable to chronic systemic inflammation. The aim of our prospective pilot study was to investigate the impact of fumaric acid esters (FAE), a first-line systemic antipsoriatic treatment in Germany, on cardiovascular risk parameters. Participants with moderate-to-severe psoriasis from the University Medical Center Mannheim and the University Hospital Würzburg were treated with FAE for 16 weeks according to standard dosage recommendations. Disease severity, life quality and depression scores as well as biomarkers of inflammation, lipid and glucose metabolism were assessed prior to initiation of FAE and after 16 weeks. Out of 39 participants recruited, 27 completed the study. 44% of all participants and 63% of those completing the 16-week treatment achieved PASI 50 response and 27 or 37% PASI 75 response. Clinical improvement was paralleled by significant improvement in quality of life, high treatment satisfaction and significant reduction of depressive symptoms. Adverse events, most frequently mild gastrointestinal complaints, flush and lymphocytopenia occurred in 89%. FAE did not modify glucose metabolism or inflammatory parameters substantially. However, a highly significant increase in serum levels of the atheroprotective cytokine adiponectin was noted after 16 weeks (median 4.7 vs. 8.9 µg/ml; p = 0.0002). Our study demonstrates a significant beneficial impact of FAE on adiponectin, indicating a potential cardioprotective effect. It will be interesting to verify this finding in larger cohorts and to assess the long-term influence of FAE on cardiovascular risk and disease.

Five-months-postoperative neuropsychological outcome from a pilot prospective randomized clinical trial of thalamic deep brain stimulation for Tourette syndrome.

Science.gov (United States)

Schoenberg, Mike R; Maddux, Brian N; Riley, David E; Whitney, Christina M; Ogrocki, Paula K; Gould, Deborah; Maciunas, Robert J

2015-02-01

Tourette syndrome (TS) is a neuropsychiatric disorder presenting with motor and/or sonic tics associated with frontostriatal dysfunction. This study provided pilot data of the neuropsychological safety of bilateral thalamic deep brain stimulation (DBS) to treat medication-refractory TS in adults. This study used a repeated-measures design with pretest and 3-month follow-up from start of continuous bilateral DBS. Five male patients underwent DBS surgery for medically refractory TS. Repeated-measures ANOVA was used to evaluate for any change in neuropsychological test scores, employing a false discovery rate. Outcome measures included 14 neuropsychological tests assessing psychomotor speed, attention, memory, language, visuoconstructional, and executive functions, as well as subjective mood ratings of depression and anxiety. Average age was 28.2 years (SD = 7.5) with 12-17 years of education. Participants were disabled by tics, with a tic frequency of 50-80 per minute before surgery. At baseline, subjects' cognitive function was generally average, although mild deficits in sequencing and verbal fluency were present, as were clinically mild obsessive-compulsive symptoms. At 3 months of continuous DBS (5 months after implantation), 3 of 5 participants had clinical reductions in motor and sonic tics. Cognitive scores generally remained stable, but declines of moderate to large effect size (Cohen's d > 0.6) in verbal fluency, visual immediate memory, and reaction time were observed. Fewer symptoms of depression and anxiety, as well as fewer obsessions and compulsions, were reported after 3 months of continuous high-frequency DBS. Bilateral centromedian-parafascicular thalamic DBS for medically refractory TS shows promise for treatment of medically refractory TS without marked neuropsychological morbidity. Symptoms of depression and anxiety improved. © 2014 International Neuromodulation Society.

Evaluation the efficacy of trichloroacetic acid (TCA) 33% in treatment of oral retinoid-induced cheilitis compared with placebo (Vaseline): a randomized pilot study.

Science.gov (United States)

Mansouri, Parvin; Azizian, Zahra; Hejazi, Somayeh; Chalangari, Reza; Chalangari, Katalin Martits

2018-03-06

Oral Isotretinoin (13-cis-retinoic acid) is a gold standardtreatment for severe forms of acne with cheilitis as a most frequent complication. We designed this novel study to investigate the therapeutic effect of trichloroacetic acid (TCA) 33% as compared with placebo to treat cheilitis. In this pilot study, 90 acne vulgaris patients between 18 and 50 years, who referred dermatologic clinic with cheilitis, were assigned to either case (TCA) or control (Vaseline) group using permuted-block randomization from 2013 to 2015 with data analysis in 2016. Patients had follow-up visits after 2 and 6 weeks, at which their lesions were photographed. Two blinded expert dermatologists recorded physician International global score for each image. Ninety eligible patients were randomly allocated into two groups. This included 45 patients in each group. At the end of follow-up, 44 patients in the intervention group and 37 patients in control group completed the final assessment. Compared to the control group, the TCA group had a greater reduction in the mean ICGS value from baseline to Week 6 (mean difference 2.59 points, p TCA can be considered as a good strategy in improvement of cheilitis to isotretinoin therapy.

Efficacy of Wii-Fit on Static and Dynamic Balance in Community Dwelling Older Veterans: A Randomized Controlled Pilot Trial

Directory of Open Access Journals (Sweden)

Kalpana P. Padala

2017-01-01

Full Text Available Background/Objectives. Balance problems are well-established modifiable risk factors for falls, which are common in older adults. The objective of this study was to establish the efficacy of a Wii-Fit interactive video-game-led physical exercise program to improve balance in older Veterans. Methods. A prospective randomized controlled parallel-group trial was conducted at Veterans Affairs Medical Center. Thirty community dwelling Veterans aged 68 (±6.7 years were randomized to either the exercise or control groups. The exercise group performed Wii-Fit program while the control group performed a computer-based cognitive program for 45 minutes, three days per week for 8-weeks. The primary (Berg Balance Scale (BBS and secondary outcomes (fear of falling, physical activity enjoyment, and quality of life were measured at baseline, 4 weeks, and 8 weeks. Results. Of 30 randomized subjects, 27 completed all aspects of the study protocol. There were no study-related adverse events. Intent-to-treat analysis showed a significantly greater improvement in BBS in the exercise group (6.0; 95% CI, 5.1–6.9 compared to the control group (0.5; 95% CI, −0.3–1.3 at 8 weeks (average intergroup difference (95% CI, 5.5 (4.3–6.7, p < 0.001 after adjusting for baseline. Conclusion. This study establishes that the Wii-Fit exercise program is efficacious in improving balance in community dwelling older Veterans. This trial is registered with ClinicalTrials.gov Identifier NCT02190045.

Household-based ceramic water filters for the prevention of diarrhea: a randomized, controlled trial of a pilot program in Colombia.

Science.gov (United States)

Clasen, Thomas; Garcia Parra, Gloria; Boisson, Sophie; Collin, Simon

2005-10-01

Household water treatment is increasingly recognized as an effective means of reducing the burden of diarrheal disease among low-income populations without access to safe water. Oxfam GB undertook a pilot project to explore the use of household-based ceramic water filters in three remote communities in Colombia. In a randomized, controlled trial over a period of six months, the filters were associated with a 75.3% reduction in arithmetic mean thermotolerant coliforms (TTCs) (P Health Organization limits for low risk (1-10 TTCs/100 mL), respectively, compared with 0.9% and 7.3% for control group samples. Overall, prevalence of diarrhea was 60% less among households using filters than among control households (odds ratio = 0.40, 95% confidence interval = 0.25, 0.63, P < 0.0001). However, the microbiologic performance and protective effect of the filters was not uniform throughout the study communities, suggesting the need to consider the circumstances of the particular setting before implementing this intervention.

Short-term therapy with combination dipeptidyl peptidase-4 inhibitor saxagliptin/metformin extended release (XR) is superior to saxagliptin or metformin XR monotherapy in prediabetic women with polycystic ovary syndrome: a single-blind, randomized, pilot study.

Science.gov (United States)

Elkind-Hirsch, Karen E; Paterson, Martha S; Seidemann, Ericka L; Gutowski, Hanh C

2017-01-01

To evaluate efficacy with the dipeptidyl peptidase-4 inhibitor saxagliptin (SAXA), metformin extended release (MET), and combination (SAXA-MET) in patients with polycystic ovary syndrome (PCOS) and impaired glucose regulation. Prospective, randomized, single-blind drug study. Outpatient clinic. Patients (n = 38) with PCOS (aged 18-42 years) and prediabetic hyperglycemia determined by a 75-gram oral glucose tolerance test. Patients were randomized to SAXA-MET (5 mg/2,000 mg), SAXA (5 mg), or MET (2,000 mg) for 16 weeks. Fasting and mean blood glucose, insulin sensitivity, insulin secretion, and insulin secretion-sensitivity index (IS-SI) by oral glucose tolerance tests. Free androgen index and lipid levels, average menstrual interval, and anthropometric measurements (body mass index, waist circumference, and waist/height ratio). The study was completed by 34 patients. Nineteen patients had normal glucose tolerance: 3 of 12 (25%) on MET; 6 of 11 (55%) on SAXA; and 10 of 11 (91%) on SAXA-MET (SAXA-MET statistically superior to MET) at study completion. Body mass index, waist circumference, waist/height ratio, free androgen index, insulin sensitivity, IS-SI, and menses improved in all groups; however, IS-SI and menstrual regularity were significantly better with SAXA-MET vs. MET treatment. Triglyceride, triglyceride/high-density lipoprotein cholesterol ratio and mean blood glucose significantly declined in the SAXA-MET and SAXA groups only. This pilot work provides the first evidence regarding the effects of a dipeptidyl peptidase-4 inhibitor alone and in combination with MET in this patient population. Treatment with SAXA-MET was superior to either drug alone in terms of clinical and metabolic benefits in prediabetic patients with PCOS. NCT02022007. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

The Impact of Type 2 Diabetes on the Efficacy of ADP Receptor Blockers in Patients with Acute ST Elevation Myocardial Infarction: A Pilot Prospective Study

Directory of Open Access Journals (Sweden)

Matej Samoš

2016-01-01

Full Text Available Background. The aim of this study was to validate the impact of type 2 diabetes (T2D on the platelet reactivity in patients with acute ST elevation myocardial infarction (STEMI treated with adenosine diphosphate (ADP receptor blockers. Methods. A pilot prospective study was performed. Totally 67 patients were enrolled. 21 patients had T2D. Among all study population, 33 patients received clopidogrel and 34 patients received prasugrel. The efficacy of ADP receptor blocker therapy had been tested in two time intervals using light transmission aggregometry with specific inducer and vasodilator-stimulated phosphoprotein phosphorylation (VASP-P flow cytometry assay. Results. There were no significant differences in platelet aggregability among T2D and nondiabetic (ND group. The platelet reactivity index of VASP-P did not differ significantly between T2D and ND group (59.4±30.9% versus 60.0±25.2% and 33.9±25.3% versus 38.6±29.3% in second testing. The number of ADP receptor blocker nonresponders did not differ significantly between T2D and ND patients. The time interval from ADP receptor blocker loading dosing to the blood sampling was similar in T2D and ND patients in both examinations. Conclusion. This prospective study did not confirm the higher platelet reactivity and higher prevalence of ADP receptor blocker nonresponders in T2D acute STEMI patients.

Lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage: a prospective, randomized, controlled trial (LUMAS).

Science.gov (United States)

Al-Tamimi, Yahia Z; Bhargava, Deepti; Feltbower, Richard G; Hall, Gregory; Goddard, Anthony J P; Quinn, Audrey C; Ross, Stuart A

2012-03-01

A single-center prospective randomized controlled trial has been conducted to determine if lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage reduces the prevalence of delayed ischemic neurological deficit and improves clinical outcome. Patients with World Federation of Neurological Surgeons Grade 1 to 3 aneurysmal subarachnoid hemorrhage and modified Fisher Grades 2, 3, 4, and 3+4 were randomized to either the study group of standard therapy plus insertion of a lumbar drain or the control group of standard therapy alone. The primary outcome measure was the prevalence of delayed ischemic neurological deficit. Two hundred ten patients with aneurysmal subarachnoid hemorrhage (166 female, 44 male; median age, 54 years; interquartile range, 45-62 years) were recruited into the control (n=105) and study (n=105) groups of the trial. World Federation of Neurological Surgeons grade was: 1 (n=139), 2 (n=60), and 3 (n=11); Fisher grade was: 2 (n=87), 3 (n=85), and 4 (n=38). The prevalence of delayed ischemic neurological deficit was 35.2% and 21.0% in the control and study groups, respectively (P=0.021). The prevalence of a modified Rankin Scale score of 4, 5, or 6 at Day 10 and 6 months, respectively, was 62.5% and 18.6% in the control group and 44.8% and 19.8% in the study group (P=0.009 and 0.83, respectively). Lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage has been shown to reduce the prevalence of delayed ischemic neurological deficit and improve early clinical outcome but failed to improve outcome at 6 months after aneurysmal subarachnoid hemorrhage. URL: www.clinicaltrials.gov. Unique identifier: NCT00842049.

Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST): rationale, design, and protocol of a pilot randomized clinical trial assessing the Wii gaming system.

Science.gov (United States)

Saposnik, G; Mamdani, M; Bayley, M; Thorpe, K E; Hall, J; Cohen, L G; Teasell, R

2010-02-01

Evidence suggests that increasing intensity of rehabilitation results in better motor recovery. Limited evidence is available on the effectiveness of an interactive virtual reality gaming system for stroke rehabilitation. EVREST was designed to evaluate feasibility, safety and efficacy of using the Nintendo Wii gaming virtual reality (VRWii) technology to improve arm recovery in stroke patients. Pilot randomized study comparing, VRWii versus recreational therapy (RT) in patients receiving standard rehabilitation within six months of stroke with a motor deficit of > or =3 on the Chedoke-McMaster Scale (arm). In this study we expect to randomize 20 patients. All participants (age 18-85) will receive customary rehabilitative treatment consistent of a standardized protocol (eight sessions, 60 min each, over a two-week period). The primary feasibility outcome is the total time receiving the intervention. The primary safety outcome is the proportion of patients experiencing intervention-related adverse events during the study period. Efficacy, a secondary outcome measure, will be measured by the Wolf Motor Function Test, Box and Block Test, and Stroke Impact Scale at the four-week follow-up visit. From November, 2008 to September, 2009 21 patients were randomized to VRWii or RT. Mean age, 61 (range 41-83) years. Mean time from stroke onset 25 (range 10-56) days. EVREST is the first randomized parallel controlled trial assessing the feasibility, safety, and efficacy of virtual reality using Wii gaming technology in stroke rehabilitation. The results of this study will serve as the basis for a larger multicentre trial. ClinicalTrials.gov registration# NTC692523.

A Randomized, Placebo-Controlled Pilot Study of Quetiapine-XR Monotherapy or Adjunctive Therapy to Antidepressant in Acute Major Depressive Disorder with Current Generalized Anxiety Disorder.

Science.gov (United States)

Li, Ranran; Wu, Renrong; Chen, Jun; Kemp, David E; Ren, Ming; Conroy, Carla; Chan, Philip; Serrano, Mary Beth; Ganocy, Stephen J; Calabrese, Joseph R; Gao, Keming

2016-03-01

To pilot efficacy and safety data of quetiapine-XR monotherapy or adjunctive therapy to antidepressant(s) in the acute treatment of MDD with current generalized anxiety disorder (GAD). The Mini International Neuropsychiatric Interview was used to ascertain the diagnosis of DSM-IV Axis I disorders. Eligible patients were randomly assigned to quetiapine-XR or placebo for up to 8 weeks. Changes from baseline to endpoint in Hamilton Depression Rating Scale-17 items (HAMD-17), Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impression-Severity (CGI-S), Quick Inventory of Depression Symptomatology-16 items Self-Report (QIDS-16-SR) total scores, and other outcome measures were analyzed with the last observation carried forward strategy and/or mixed-effects modeling for repeated measures. Of the 34 patients screened, 23 patients were randomized to receive quetiapine-XR (n = 11) or placebo (n = 12), with 5 and 4 completing the study, respectively. The mean dose of quetiapine-XR was 154 ± 91 mg/d. The change from baseline to endpoint in the total scores of HAMD-17, HAM-A, QIDS-16-SR, and CGI-S were significant in the quetiapine-XR group, but only the change in HAM-A total score was significant in the placebo group. The differences in these changes between the two groups were only significant in CGI-S scores, with the rest of numerical larger in the quetiapine-XR group. The most common side effects from quetiapine-XR were dry mouth, somnolence/sedation, and fatigue. In this pilot study, quetiapine-XR was numerically superior to placebo in reducing depressive and anxiety symptoms in patients with MDD and current GAD. Large sample studies are warranted to support or refute these preliminary findings.

Smartphone-Enabled Health Coaching Intervention (iMOVE) to Promote Long-Term Maintenance of Physical Activity in Breast Cancer Survivors: Protocol for a Feasibility Pilot Randomized Controlled Trial.

Science.gov (United States)

Ritvo, Paul; Obadia, Maya; Santa Mina, Daniel; Alibhai, Shabbir; Sabiston, Catherine; Oh, Paul; Campbell, Kristin; McCready, David; Auger, Leslie; Jones, Jennifer Michelle

2017-08-24

Although physical activity has been shown to contribute to long-term disease control and health in breast cancer survivors, a majority of breast cancer survivors do not meet physical activity guidelines. Past research has focused on promoting physical activity components for short-term breast cancer survivor benefits, but insufficient attention has been devoted to long-term outcomes and sustained exercise adherence. We are assessing a health coach intervention (iMOVE) that uses mobile technology to increase and sustain physical activity maintenance in initially inactive breast cancer survivors. This pilot randomized controlled trial (RCT) is an initial step in evaluating the iMOVE intervention and will inform development of a full-scale pragmatic RCT. We will enroll 107 physically inactive breast cancer survivors and randomly assign them to intervention or control groups at the University Health Network, a tertiary cancer care center in Toronto, Canada. Participants will be women (age 18 to 74 years) stratified by age (55 years and older/younger than 55 years) and adjuvant hormone therapy (AHT) exposure (AHT vs no AHT) following breast cancer treatment with no metastases or recurrence who report less than 60 minutes of preplanned physical activity per week. Both intervention and control groups receive the 12-week physical activity program with weekly group sessions and an individualized, progressive, home-based exercise program. The intervention group will additionally receive (1) 10 telephone-based health coaching sessions, (2) smartphone with data plan, if needed, (3) supportive health tracking software (Connected Wellness, NexJ Health Inc), and (4) a wearable step-counting device linked to a smartphone program. We will be assessing recruitment rates; acceptability reflected in selective, semistructured interviews; and enrollment, retention, and adherence quantitative intervention markers as pilot outcome measures. The primary clinical outcome will be directly

Tranexamic acid reduces blood loss and blood transfusions in primary total hip arthroplasty: a prospective randomized double-blind study in 40 patients

DEFF Research Database (Denmark)

Husted, Henrik; Blønd, Lars; Sonne-Holm, Stig

2003-01-01

INTRODUCTION: We performed a prospective, randomized, double-blind study on 40 patients scheduled for primary total hip arthroplasty due to arthrosis or osteonecrosis to determine the effect of tranexamic acid on per- and postoperative blood losses and on the number of blood transfusions needed....... PATIENTS AND METHODS: 40 patients were randomized to tranexamic acid (10 mg/kg given as a bolus intravenous injection, followed by a continuous infusion of 1 mg/kg/hour for 10 hours) or placebo (20 mL saline given intravenously) 15 minutes before the incision. We recorded the peroperative and postoperative...... blood losses at removal of the drain 24 hours after the operation and the number of blood transfusions. RESULTS: Patients receiving tranexamic acid had a mean peroperative blood loss of 480 mL versus 622 mL in patients receiving placebo (p = 0.3), a postoperative blood loss of 334 mL versus 609 mL (p...

Percutaneous CT-guided lung biopsy: sequential versus spiral scanning. A randomized prospective study

International Nuclear Information System (INIS)

Ghaye, B.; Dondelinger, R.F.; Dewe, W.

1999-01-01

The aim of this study was to evaluate in a prospective and randomized study spiral versus sequential scanning in the guidance of percutaneous lung biopsy. Fifty thoracic lesions occurring in 48 patients were biopsied by a senior and a junior operator. Six different time segments of the procedure were measured. Scanning mode versus length of procedure, pathological results, irradiation and complications were evaluated. Total duration of the procedure and of the first sampling was significantly longer with spiral CT for the senior operator (p < 0.004). No significant time difference was observed for the junior operator. Diameter of the lesion, depth of location, position of the patient and needle entry site did not influence the results. The sensitivity was 90.9, specificity 100, positive predictive value 100 and negative predictive value 60 % for spiral CT, and 94.7, 100, 100 and 85.7 % for sequential CT, respectively. Eleven pneumothoraces and ten perinodular hemorrhages were seen with spiral CT and six and ten, respectively, with sequential CT. The mean dose of irradiation was 4027 mAs for spiral CT and 2358 mAs for conventional CT. Spiral CT does neither reduce procedure time nor the rate of complications. Pathological results do not differ compared with sequential CT, and total dose of irradiation is higher with spiral scanning. (orig.)

76 FR 63183 - Pilot in Command Proficiency Check and Other Changes to the Pilot and Pilot School Certification...

Science.gov (United States)

2011-10-12

...-0938; Amendment Nos. 61-128, 91-324, 141-15, and 142-7] RIN 2120-AJ18 Pilot in Command Proficiency Check and Other Changes to the Pilot and Pilot School Certification Rules; Correction AGENCY: Federal... regulations to revise the pilot, flight instructor, and pilot school certification requirements. In particular...

Effects of quetiapine and olanzapine in patients with psychosis and violent behavior: a pilot randomized, open-label, comparative study

Directory of Open Access Journals (Sweden)

Gobbi G

2014-05-01

Full Text Available Gabriella Gobbi,1,2 Stefano Comai,1 Guy Debonnel1,2,† 1Neurobiological Psychiatric Unit, Department of Psychiatry, McGill University and McGill University Health Center, 2Institut Philippe Pinel, Department of Psychiatry, Université de Montréal, Montréal, QC, Canada †Guy Debonnel passed away on November 4, 2006 Objective: Patients suffering from psychosis are more likely than the general population to commit aggressive acts, but the therapeutics of aggressive behavior are still a matter of debate. Methods: This pilot randomized, open-label study compared the efficacy of quetiapine versus olanzapine in reducing impulsive and aggressive behaviors (primary endpoints and psychotic symptoms (secondary endpoints from baseline to days 1, 7, 14, 28, 42, 56, and 70, in 15 violent schizophrenic patients hospitalized in a maximum-security psychiatric hospital. Results: Quetiapine (525±45 mg and olanzapine (18.5±4.8 mg were both efficacious in reducing Impulsivity Rating Scale from baseline to day 70. In addition, both treatments reduced the Brief Psychiatric Rating Scale, Positive and Negative Syndrome Scale, and Clinical Global Impression Scale scores at day 70 compared to baseline, and no differences were observed between treatments. Moreover, quetiapine, but not olanzapine, yielded an improvement of depressive symptoms in the items “depression” in Brief Psychiatric Rating Scale and “blunted affect” in Positive and Negative Syndrome Scale. Modified Overt Aggression Scale scores were also decreased from baseline to the endpoint, but due to the limited number of patients, it was not possible to detect a significant difference. Conclusion: In this pilot study, quetiapine and olanzapine equally decreased impulsive and psychotic symptoms after 8 weeks of treatment. Double-blind, large studies are needed to confirm the validity of these two treatments in highly aggressive and violent schizophrenic patients. Keywords: schizophrenia, aggression

14 CFR 61.73 - Military pilots or former military pilots: Special rules.

Science.gov (United States)

2010-01-01

... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Military pilots or former military pilots... Ratings and Pilot Authorizations § 61.73 Military pilots or former military pilots: Special rules. (a... a disciplinary action involving aircraft operations, a U.S. military pilot or former military pilot...

A pilot randomized controlled trial comparing the efficacy of exercise, spinal manipulation, and neuro emotional technique for the treatment of pregnancy-related low back pain

Directory of Open Access Journals (Sweden)

Peterson Caroline D

2012-06-01

Full Text Available Abstract Background This pilot randomized controlled trial evaluated the feasibility of conducting a full scale study and compared the efficacy of exercise, spinal manipulation, and a mind-body therapy called Neuro Emotional Technique for the treatment of pregnancy-related low back pain, a common morbidity of pregnancy. Methods Healthy pregnant women with low back pain of insidious onset were eligible to enroll in the study at any point in their pregnancy. Once enrolled, they remained in the study until they had their babies. Women were randomly allocated into one of three treatment groups using opaque envelopes. The treatment schedule paralleled the prenatal care schedule and women received individualized intervention. Our null hypothesis was that spinal manipulation and Neuro Emotional Technique would perform no better than exercise in enhancing function and decreasing pain. Our primary outcome measure was the Roland Morris Disability Questionnaire and our secondary outcome measure was the Numeric Pain Rating Scale. Intention to treat analysis was conducted. For the primary analysis, regression was conducted to compare groups on the outcome measure scores. In a secondary responder analysis, difference in proportions of participants in attaining 30% and 50% improvement were calculated. Feasibility factors for conducting a future larger trial were also evaluated such as recruitment, compliance to study protocols, cost, and adverse events. Results Fifty-seven participants were randomized into the exercise (n = 22, spinal manipulation (n = 15, and Neuro Emotional Technique (n = 20 treatment arms. At least 50% of participants in each treatment group experienced clinically meaningful improvement in symptoms for the Roland Morris Disability Questionnaire. At least 50% of the exercise and spinal manipulation participants also experienced clinically meaningful improvement for the Numeric Pain Rating Scale. There were no clinically

Practical Implications of Metacognitively Oriented Psychotherapy in Psychosis : Findings From a Pilot Study

NARCIS (Netherlands)

de Jong, Steven; van Donkersgoed, Rozanne J. M.; Aleman, Andre; van der Gaag, Mark; Wunderink, Lex; Arends, Johan; Lysaker, Paul H.; Pijnenborg, Marieke

In preparation for a multicenter randomized controlled trial, a pilot study was conducted investigating the feasibility and acceptance of a shortened version (12 vs. 40 sessions) of an individual metacognitive psychotherapy (Metacognitive Reflection and Insight Therapy [MERIT]). Twelve participants

A psycho-educational HIV/STI prevention intervention for internally displaced women in Leogane, Haiti: results from a non-randomized cohort pilot study.

Science.gov (United States)

Logie, Carmen H; Daniel, CarolAnn; Newman, Peter A; Weaver, James; Loutfy, Mona R

2014-01-01

Little evidence exists regarding efficacious HIV and sexually transmitted infections (STI) prevention interventions with internally displaced populations. Internally displaced women are at elevated risk for HIV/STI due to limited access to health services, heightened poverty and social network breakdown. The FASY (Famn an Aksyon Pou Sante' Yo) (Women Taking Action For Their Health) study examined the effectiveness of a peer health worker (PHW) delivered psycho-educational HIV/STI pilot study with internally displaced women in Leogane, Haiti. This was a non-randomized cohort pilot study. Participants completed a computer-assisted pre-test programmed on Android tablet PCs followed by an HIV/STI educational video-based session and a 6-week psycho-educational group program of weekly meetings. Participants completed a post-test upon completion of group sessions. The primary outcome was HIV knowledge; our pre-specified index of clinically significant change was an effect size of 0.30. Secondary outcomes included: STI knowledge, condom use, social support, resilient coping, depression and relationship control. We used mixed-effects regression to calculate mean outcome pre-post score change. This study was registered (clinicaltrials.gov, NCT01492829). Between January 1-April 30, 2012 we assigned 200 participants to the study. The majority of participants (n = 176, 88%) completed the study and were followed up at 8 weeks, finishing April 30, 2012. Adjusted for socio-demographic characteristics, HIV knowledge (β = 4.81; 95% CI 4.36-5.26), STI knowledge (β = 0.84; 95% CI 0.70-0.99), condom use (AOR = 4.05, 95% CI 1.86-8.83), and depression (β = -0.63, 95% CI -0.88--0.39) scores showed statistically significant change post-intervention (pHaiti. Pilot studies are an important approach to understand feasibility and scientific impacts of HIV prevention strategies in disaster contexts. Study results may inform HIV prevention interventions among internally displaced women in

Patient participation in cancer clinical trials: A pilot test of lay navigation

Directory of Open Access Journals (Sweden)

Kathleen B. Cartmell

2016-08-01

Conclusions: In this formative single-arm pilot project, initial evidence was found for the potential effect of a lay navigation intervention on CT understanding and enrollment. A randomized controlled trial is needed to examine the efficacy of the intervention for improving CT education and enrollment.

Targeted prevention of lifestyle related diseases in the primary care sector – results from the TOF pilot project

DEFF Research Database (Denmark)

Bruun Larsen, Lars; Thilsing, Trine

This abstract reports on the results of a non-randomized pilot study carried out to test the acceptability, feasibility and short-term effects of a healthcare intervention in primary care. The intervention is designed to systematically identify persons at risk of developing lifestyle-related dise...... is facilitated by a digital support system. The pilot makes use of both quantitative and qualitative research methods....... prevention and health promotion is required. This has been attempted in past efforts by offering individual preventive health checks to the general population. However, the evidence on the effectiveness of this approach is mixed. Several systematic reviews, on the other hand, suggest that health checks......This abstract reports on the results of a non-randomized pilot study carried out to test the acceptability, feasibility and short-term effects of a healthcare intervention in primary care. The intervention is designed to systematically identify persons at risk of developing lifestyle...

Fluoxetine for Maintenance of Remission and to Improve Quality of Life in Patients with Crohn's Disease: a Pilot Randomized Placebo-Controlled Trial.

Science.gov (United States)

Mikocka-Walus, Antonina; Hughes, Patrick A; Bampton, Peter; Gordon, Andrea; Campaniello, Melissa A; Mavrangelos, Chris; Stewart, Benjamin J; Esterman, Adrian; Andrews, Jane M

2017-04-01

Previous studies have shown that antidepressants reduce inflammation in animal models of colitis. The present trial aimed to examine whether fluoxetine added to standard therapy for Crohn's disease [CD] maintained remission, improved quality of life [QoL] and/or mental health in people with CD as compared to placebo. A parallel randomized double-blind placebo controlled trial was conducted. Participants with clinically established CD, with quiescent or only mild disease, were randomly assigned to receive either fluoxetine 20 mg daily or placebo, and followed for 12 months. Participants provided blood and stool samples and completed mental health and QoL questionnaires. Immune functions were assessed by stimulated cytokine secretion [CD3/CD28 stimulation] and flow cytometry for cell type. Linear mixed-effects models were used to compare groups. Of the 26 participants, 14 were randomized to receive fluoxetine and 12 to placebo. Overall, 14 [54%] participants were male. The mean age was 37.4 [SD=13.2] years. Fluoxetine had no effect on inflammatory bowel disease activity measured using either the Crohn's Disease Activity Index [F(3, 27.5)=0.064, p=0.978] or faecal calprotectin [F(3, 32.5)=1.08, p=0.371], but did have modest effects on immune function. There was no effect of fluoxetine on physical, psychological, social or environmental QoL, anxiety or depressive symptoms as compared to placebo [all p>0.05]. In this small pilot clinical trial, fluoxetine was not superior to placebo in maintaining remission or improving QoL. [ID: ACTRN12612001067864.]. © European Crohn’s and Colitis Organistion (ECCO) 2016.

The effectiveness of the Incredible Years Parents and Babies Program as a universal prevention intervention for parents of infants in Denmark: study protocol for a pilot randomized controlled trial

DEFF Research Database (Denmark)

Pontoppidan, Maiken W.

2015-01-01

support parents in providing sensitive and responsive care, and reinforce healthy development for their infants. This study aims to evaluate the impact of the Incredible Years™ Parents and Babies Program in a universal setting for parents with infants. Methods/Design: This is a pragmatic, two......-arm, parallel, pilot, randomized controlled trial (RCT) where 128 families with newborn infants up to four-months-old are recruited in two municipalities in Denmark. Families are randomized to the Incredible Years Parents and Babies Program or usual care with a 2:1 allocation ratio. The primary outcome....... Discussion: This is the first RCT of the Incredible Years Parents and Babies Program, and one of the first rigorous evaluations of a universally offered preventive intervention for parents with infants. The trial will provide important information on the effectiveness of a relatively brief, universally...

Tamsulosin versus tadalafil as a medical expulsive therapy for distal ureteral stones: A prospective randomized study.

Science.gov (United States)

Kc, Hari Bahadur; Shrestha, Anil; Acharya, Ganesh Bhakta; Basnet, Robin Bahadur; Shah, Arvind Kumar; Shrestha, Parash Mani

2016-09-01

This study aimed to compare the safety and efficacy of tamsulosin and tadalafil as medical expulsive therapy for distal ureteral stones. This prospective randomized study was conducted at the Department of Urology of Bir Hospital over a period of 12 months in patients with distal ureteral stones sized 5 to 10 mm. Patients were randomly divided into 2 groups: group A received tamsulosin 0.4 mg and group B received tadalafil 10 mg at bedtime for 2 weeks. Stone expulsion rate, number of ureteric colic episodes and pain score, analgesic requirements, and adverse drug effects were noted in both groups. Statistical analyses were performed by using Student t-test and chi-square test. Altogether 85 patients, 41 in group A and 44 in group B, were enrolled in the study. The patients' average age was 31.72±12.63 years, and the male-to-female ratio was 1.5:1. Demographic profiles, stone size, and baseline investigations were comparable between the 2 groups. The stone expulsion rate was significantly higher in the tadalafil group than in the tamsulosin group (84.1% vs. 61.0%, p=0.017). Although the occurrence of side effects was higher with tadalafil, this difference was not significant (p=0.099). There were no serious adverse effects. Tadalafil has a significantly higher stone expulsion rate than tamsulosin when used as a medical expulsive therapy for distal ureteral stones sized 5-10 mm. Both drugs are safe, effective, and well tolerated with minor side effects.

Open release versus radiofrequency microtenotomy in the treatment of lateral epicondylitis: a prospective randomized controlled trial.

Science.gov (United States)

Hamlin, Katharine; Munro, Christopher; Barker, Scott L; McKenna, Sean; Kumar, Kapil

2018-01-01

Optimal surgical treatment of lateral epicondylitis remains uncertain. Recently, radiofrequency microtenotomy (RFMT) has been proposed as a suitable treatment. We compared RFMT with standard open release (OR) in this prospective randomized controlled trial. In total, 41 patients with symptoms for at least 6 months were randomized into two groups: 23 patients had RFMT and 18 had OR. Two patients from RFMT withdrew. Each patient underwent Numerical Rating Scale (NRS) pain score, grip strength and Disabilities of the Arm, Shoulder and Hand (DASH) scores pre-operatively and at 6 weeks. Pain and DASH scores were repeated at 6 months and 12 months. NRS pain scores improved by 4.8 points for RFMT and by 3.9 points for OR. There was a significant improvement in both groups from pre-operative scores, although there was no statistically significant difference between the groups at 1 year. Grip strength improved by 31% in the RFMT group compared to 38% in OR. There was no significant difference between the initial and 6 weeks scores or between treatments. At 1 year, DASH was 39.8 points for RFMT and 24.4 points for OR. There was a significant improvement in both groups from pre-operative scores, although there was no statistically significant difference between the groups at 1 year. Both groups showed significant improvements and similar benefit to the patient. The results of the present study do not show any benefit of RFMT over the standard OR. As a result of the extra expense of RFMT, we therefore recommend that OR is offered as the standard surgical management.

Tribulus terrestris versus placebo in the treatment of erectile dysfunction: A prospective, randomized, double blind study.

Science.gov (United States)

Santos, C A; Reis, L O; Destro-Saade, R; Luiza-Reis, A; Fregonesi, A

2014-05-01

To evaluate the possible effects of Tribulus terrestris herbal medicine in the erectile dysfunction treatment and to quantify its potential impact on serum testosterone levels. Prospective, randomized, double-blind and placebo-controlled study including thirty healthy men selected from 100 patients who presented themselves spontaneously complaining of erectile dysfunction, ≥ 40 years of age, nonsmokers, not undergoing treatment for prostate cancer or erectile dysfunction, no dyslipidemia, no phosphodiesterase inhibitor use, no hormonal manipulation and, if present hypertension and/or diabetes mellitus should be controlled. International Index of Erectile Function (IIEF-5) and serum testosterone were obtained before randomization and after 30 days of study. Patients were randomized into two groups of fifteen subjects each. The study group received 800 mg of Tribulus terrestris, divided into two doses per day for thirty days and the control group received placebo administered in the same way. The groups were statistically equivalent in all aspects evaluated. The mean (SD) age was 60 (9.4) and 62.9 (7.9), P = .36 for intervention and placebo groups, respectively. Before treatment, the intervention group showed mean IIEF-5 of 13.2 (5-21) and mean total testosterone 417.1 ng/dl (270.7-548.4 ng/dl); the placebo group showed mean IIEF-5 of 11.6 (6-21) and mean total testosterone 442.7 ng/dl (301-609.1 ng/dl). After treatment, the intervention group showed mean IIEF-5 of 15.3 (5-21) and mean total testosterone 409.3 ng/dl (216.9-760.8 ng/dl); the placebo group showed mean IIEF-5 of 13.7 (6-21) and mean total testosterone 466.3 ng/dl (264.3-934.3 ng/dl). The time factor caused statistically significant changes in both groups for IIEF-5 only (P = .0004), however, there was no difference between the two groups (P = .7914). At the dose and interval studied, Tribulus terrestris was not more effective than placebo on improving symptoms of erectile dysfunction or serum total

Adult Congenital Heart Disease-Coping And REsilience (ACHD-CARE): Rationale and methodology of a pilot randomized controlled trial.

Science.gov (United States)

Kovacs, Adrienne H; Bandyopadhyay, Mimi; Grace, Sherry L; Kentner, Amanda C; Nolan, Robert P; Silversides, Candice K; Irvine, M Jane

2015-11-01

One-third of North American adults with congenital heart disease (CHD) have diagnosable mood or anxiety disorders and most do not receive mental health treatment. There are no published interventions targeting the psychosocial needs of patients with CHD of any age. We describe the development of a group psychosocial intervention aimed at improving the psychosocial functioning, quality of life, and resilience of adults with CHD and the design of a study protocol to determine the feasibility of a potential full-scale randomized controlled trial (RCT). Drawing upon our quantitative and qualitative research, we developed the Adult CHD-Coping And REsilience (ACHD-CARE) intervention and designed a feasibility study that included a 2-parallel arm non-blinded pilot RCT. Eligible participants (CHD, age ≥ 18 years, no planned surgery, symptoms suggestive of a mood and/or anxiety disorder) were randomized to the ACHD-CARE intervention or Usual Care (1:1 allocation ratio). The group intervention was delivered during eight 90-minute weekly sessions. Feasibility will be assessed in the following domains: (i) process (e.g. recruitment and retention), (ii) resources, (iii) management, (iv) scientific outcomes, and (v) intervention acceptability. This study underscores the importance of carefully developing and testing the feasibility of psychosocial interventions in medical populations before moving to full-scale clinical trials. At study conclusion, we will be poised to make one of three determinations for a full-scale RCT: (1) feasible, (2) feasible with modifications, or (3) not feasible. This study will guide the future evaluation and provision of psychosocial treatment for adults with CHD. Copyright © 2015. Published by Elsevier Inc.

A mindfulness-based intervention to control weight after bariatric surgery: Preliminary results from a randomized controlled pilot trial.

Science.gov (United States)

Chacko, Sara A; Yeh, Gloria Y; Davis, Roger B; Wee, Christina C

2016-10-01

This study aimed to develop and test a novel mindfulness-based intervention (MBI) designed to control weight after bariatric surgery. Randomized, controlled pilot trial. Beth Israel Deaconess Medical Center, Boston, MA, USA. Bariatric patients 1-5 years post-surgery (n=18) were randomized to receive a 10-week MBI or a standard intervention. Primary outcomes were feasibility and acceptability of the MBI. Secondary outcomes included changes in weight, eating behaviors, psychosocial outcomes, and metabolic and inflammatory biomarkers. Qualitative exit interviews were conducted post-intervention. Major themes were coded and extracted. Attendance was excellent (6 of 9 patients attended ≥7 of 10 classes). Patients reported high satisfaction and overall benefit of the MBI. The intervention was effective in reducing emotional eating at 6 months (-4.9±13.7 in mindfulness vs. 6.2±28.4 in standard, p for between-group difference=0.03) but not weight. We also observed a significant increase in HbA1C (0.34±0.38 vs. -0.06±0.31, p=0.03). Objective measures suggested trends of an increase in perceived stress and symptoms of depression, although patients reported reduced stress reactivity, improved eating behaviors, and a desire for continued mindfulness-based support in qualitative interviews. This novel mindfulness-based approach is highly acceptable to bariatric patients post-surgery and may be effective for reducing emotional eating, although it did not improve weight or glycemic control in the short term. Longer-term studies of mindfulness-based approaches may be warranted in this population. ClinicalTrials.gov identifier NCT02603601. Copyright © 2016 Elsevier Ltd. All rights reserved.