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Sample records for blinded pilot study

  1. Vasopressin vs Dopamine for Treatment of Hypotension in ELBW Infants: A Randomized, Blinded Pilot Study

    Science.gov (United States)

    Rios, Danielle R.; Kaiser, Jeffrey R.

    2015-01-01

    Objective To evaluate vasopressin vs dopamine as initial therapy in ELBW infants with hypotension during the first 24 hours of life. Study design Hypotensive ELBW infants ≤ 30 weeks’ gestation and ≤ 24 hours old randomly received treatment with vasopressin or dopamine in a blinded fashion. Normotensive infants not receiving vasopressor support served as a comparison group. Results Twenty hypotensive ELBW infants received vasopressin (n=10) or dopamine (n=10), and 50 were enrolled for comparison. Mean gestational age was 25.6 ± 1.4 weeks and birth weight 705 ± 154 g. Response to vasopressin paralleled that of dopamine in time to adequate mean BP (Kaplan-Meier curve, p=0.986); 90% of infants in each treatment group responded with adequate BP. The vasopressin group received fewer doses of surfactant (phypotension appeared safe. This pilot study supports a larger randomized controlled trial of vasopressin vs dopamine therapy in ELBW infants with hypotension. PMID:25641242

  2. 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

  3. The Social Life and Emotional State of Adolescent Children of Parents Who Are Blind and Sighted: A Pilot Study

    Science.gov (United States)

    Duvdevany, Ilana; Moin, Victor; Yahav, Rivka

    2007-01-01

    This pilot study compared the development of two groups of adolescents--those whose parents were blind and those whose parents were sighted. It found that there were no essential differences between the groups. Moreover, the friendship relationships, feelings toward parents, and some essential characteristics of the adolescents' emotional state…

  4. Single-blind, randomized, pilot study combining shiatsu and amitriptyline in refractory primary headaches.

    Science.gov (United States)

    Villani, Veronica; Prosperini, Luca; Palombini, Fulvio; Orzi, Francesco; Sette, Giuliano

    2017-06-01

    Complementary alternative medicine, such as shiatsu, can represent a suitable treatment for primary headaches. However, evidence-based data about the effect of combining shiatsu and pharmacological treatments are still not available. Therefore, we tested the efficacy and safety of combining shiatsu and amitriptyline to treat refractory primary headaches in a single-blind, randomized, pilot study. Subjects with a diagnosis of primary headache and who experienced lack of response to ≥2 different prophylactic drugs were randomized in a 1:1:1 ratio to receive shiatsu plus amitriptyline, shiatsu alone, or amitriptyline alone for 3 months. Primary endpoint was the proportion of patients experiencing ≥50%-reduction in headache days. Secondary endpoints were days with headache per month, visual analogue scale, and number of pain killers taken per month. After randomization, 37 subjects were allocated to shiatsu plus amitriptyline (n = 11), shiatsu alone (n = 13), and amitriptyline alone (n = 13). Randomization ensured well-balanced demographic and clinical characteristics at baseline. Although all the three groups improved in terms of headache frequency, visual analogue scale score, and number of pain killers (p < 0.05), there was no between-group difference in primary endpoint (p = ns). Shiatsu (alone or in combination) was superior to amitriptyline in reducing the number of pain killers taken per month (p < 0.05). Seven (19%) subjects reported adverse events, all attributable to amitriptyline, while no side effects were related with shiatsu treatment. Shiatsu is a safe and potentially useful alternative approach for refractory headache. However, there is no evidence of an additive or synergistic effect of combining shiatsu and amitriptyline. These findings are only preliminary and should be interpreted cautiously due to the small sample size of the population included in our study. Trial registration 81/2010 (Ethical Committee, S. Andrea Hospital

  5. A Double-Blind, Placebo-Controlled Study of Risperidone for the Treatment of Adolescents and Young Adults with Anorexia Nervosa: A Pilot Study

    Science.gov (United States)

    Hagman, Jennifer; Gralla, Jane; Sigel, Eric; Ellert, Swan; Dodge, Mindy; Gardner, Rick; O'Lonergan, Teri; Frank, Guido; Wamboldt, Marianne Z.

    2011-01-01

    Objective: The purpose of this double-blind, placebo-controlled exploratory pilot study was to evaluate the safety and efficacy of risperidone for the treatment of anorexia nervosa. Method: Forty female subjects 12 to 21 years of age (mean, 16 years) with primary anorexia nervosa in an eating disorders program were randomized to receive…

  6. Acupucture in the treatment of scoliosis – a single blind controlled pilot study

    OpenAIRE

    Weiss, Hans-Rudolf; Bohr, Silvia; Jahnke, Anja; Pleines, Sandra

    2008-01-01

    Abstract Background Today, acupuncture therapy is commonly used for pain control throughout the world, although the putative mechanisms are still unclear. A Pub Med search for the key words "Acupuncture" and "Scoliosis" reveals 3 papers only, not containing any results of studies designed for the treatment of scoliosis with the help of acupuncture. Because of this lack of trials especially designed for the treatment of scoliosis this pilot study has been performed. Methods 24 girls undergoing...

  7. A Double-Blind Randomized Pilot Study Comparing Quetiapine and Divalproex for Adolescent Mania

    Science.gov (United States)

    Delbello, Melissa P.; Kowatch, Robert A.; Adler, Caleb M.; Stanford, Kevin E.; Welge, Jeffrey A.; Barzman, Drew H.; Nelson, Erik; Strakowski, Stephen M.

    2006-01-01

    Objective: To determine the comparative efficacy of quetiapine and divalproex for the treatment of adolescent mania. Method: Fifty adolescents (ages 12-18 years) with bipolar I disorder, manic or mixed episode, were randomized to quetiapine (400-600 mg/day) or divalproex (serum level 80-120 [micro]g/mL) for 28 days for this double-blind study,…

  8. Midodrine in patients with spinal cord injury and anejaculation: A double-blind randomized placebo-controlled pilot study.

    Science.gov (United States)

    Leduc, Bernard E; Fournier, Christine; Jacquemin, Géraldine; Lepage, Yves; Vinet, Bernard; Hétu, Pierre-Olivier; Chagnon, Miguel

    2015-01-01

    The objective of this study is to evaluate the efficacy of midodrine in the treatment of anejaculation in men with spinal cord injury (SCI). Prospective, double-blind, randomized, placebo-controlled pilot study. Men with anejaculation associated with SCI (level of injury above T10) of more than 1 year in duration were approached. Those with no ejaculatory response to one penile vibratory stimulation (PVS) trial were assigned in a double-blind manner to one of the two following interventions once a week for a maximum of 3 weeks or until ejaculation occurred: oral administration of flexible midodrine (7.5-22.5 mg max) followed by PVS (group M), or oral administration of flexible sham-midodrine (placebo) followed by PVS (group P). Sociodemographic data, medical characteristics, and plasma desglymidodrine concentration were collected for all participants. Ejaculation success rate in each group. Among the 78 men approached, 23 participants (level of SCI: C4-T9) were randomized. Three participants abandoned the study and 20 completed the study; 10 were assigned to group M, 10 to group P. Ejaculation was reached for one participant of group M and for two participants of group P. Autonomic dysreflexia associated to PVS occurred in three patients. In this small sample study, treatment of anejaculation after SCI with midodrine and PVS did not result in a better rate of antegrade ejaculation in 10 men than in 10 men treated with a placebo and PVS.

  9. Impact of protein supplementation after bariatric surgery: A randomized controlled double-blind pilot study.

    Science.gov (United States)

    Schollenberger, Asja E; Karschin, Judith; Meile, Tobias; Küper, Markus A; Königsrainer, Alfred; Bischoff, Stephan C

    2016-02-01

    Bariatric patients are at risk of protein deficiency. The aim of this study was to determine possible benefits of postoperative protein supplementation weight reduction, body composition, and protein status. Twenty obese patients who underwent bariatric surgery were randomized either to the protein (PRO) group, which received a daily protein supplement over 6 months postoperatively, or to the control (CON) group, which received an isocaloric placebo in a double-blind fashion. Data on protein and energy intake, body weight, body composition, blood proteins, and grip force was collected preinterventionally and at 1, 3, and 6 months postoperatively. In both groups body weight was significantly reduced to a similar extent (after 6 months: PRO group 25.4 ± 7.2%, CON group 20.9 ± 3.9%; intergroup comparison P > 0.05). Protein intake was steadily increased in the PRO group, but not in the CON group, and reached maximum at month 6 (25.4 ± 3.7% of energy intake versus 15.8 ± 4.4%; P bariatric surgery improves body composition by enhancing loss of body fat mass and reducing loss of lean body mass within the 6 months follow up. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. Treatment of eyebrow hypotrichosis using bimatoprost: a randomized, double-blind, vehicle-controlled pilot study.

    Science.gov (United States)

    Beer, Kenneth R; Julius, Hillary; Dunn, Monica; Wilson, Fred

    2013-07-01

    The Food and Drug Administration has approved bimatoprost ophthalmic solution (0.03%) for the treatment of eyelash hypotrichosis. Previous reports of its efficacy in eyebrow hypotrichosis are anecdotal. To assess the efficacy and safety of bimatoprost 0.03% ophthalmic solution applied to the eyebrows in a randomized, double-blind, vehicle-controlled study. Subjects (n = 20) with mild to moderate eyebrow hypotrichosis enrolled in the study. One group (Bim) applied bimatoprost to each eyebrow daily for 9 months, and another applied vehicle nightly to each eyebrow for 5 months. Subjects in the latter group were re-randomized to apply bimatoprost (Veh-Bim Group) or vehicle (Veh Group) daily to each eyebrow for 4 months. The primary end point was investigator-assessed eyebrow appearance; secondary end points were subject-reported outcomes. Investigator assessments showed significant improvements from baseline to 6 (p = .002) and 7 (p = .005) months for the eyebrows treated with bimatoprost. p-Values for the Veh-Bim and Veh groups were not significant at any time point. End-of-study subject satisfaction with eyebrow fullness or thickness and darkness or color was greater in the Bim group than in the Veh group. Adverse effects were not observed. Bimatoprost 0.03% ophthalmic solution applied daily for 9 months improves the appearance of eyebrows noticeably more than vehicle, without side effects. © 2013 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.

  11. Physical and psychosocial benefits of modified judo practice for blind, mentally retarded children: a pilot study.

    Science.gov (United States)

    Gleser, J M; Margulies, J Y; Nyska, M; Porat, S; Mendelberg, H; Wertman, E

    1992-06-01

    A modified form of judo training was practiced by a class of 7 blind, mentally retarded children with associated neuropsychiatric disturbances. The biweekly training program lasted for 6 months. Analysis indicated improvements in physical fitness, motor skills, and psychosocial attitude. The authors concluded that a modified form of judo can be used as a therapeutic, educational, and recreational tool for multiply handicapped children.

  12. Effects of Suspended Moxibustion on Delayed Onset Muscle Soreness: A Randomized Controlled Double-Blind Pilot Study.

    Science.gov (United States)

    Meng, Ding; Xiaosheng, Dong; Xuhui, Wang; Xu, Wang; Xijin, Zhang

    2017-06-01

    The objective of this study was to investigate the effects of suspended moxibustion upon tender point on delayed onset muscle soreness. The study was a randomized double-blind controlled trial with 50 subjects in each group. Subjects in moxibustion group received suspended moxibustion upon tender point (by palpation) twice. The controls received no treatment. Each subject received treatments twice, 24 hr and 48 hr after the delayed onset muscle soreness induction. The measurements of Pain Visual Analog Scale, maximum isometric muscle strength and circumference were made immediately after delayed onset muscle soreness induction, before and after every treatment session and 72 hr after delayed onset muscle soreness induction. There were no significantly statistical differences between two groups at all measurement time points on maximum isometric muscle strength and circumference. However, the Pain Visual Analog Scale scores after first treatment session and 72 hr after delayed onset muscle soreness induction in moxibustion group was less than the control group, with significant difference (p soreness. However, results need to be cautiously interpreted because of the pilot character of this study. The suspended moxibustion has a potential effect of pain relief on DOMS from the analysis of the data of this study. A large sample size trial is needed to confirm the effect of the suspended moxibustion on DOMS in the future.

  13. Association of cardiac development with assisted reproductive technology in childhood: a prospective single-blind pilot study.

    Science.gov (United States)

    Zhou, Jie; Liu, Hong; Gu, Hai-tao; Cui, Yu-gui; Zhao, Nan-nan; Chen, Juan; Gao, Li; Zhang, Yuan; Liu, Jia-yin

    2014-01-01

    To examine the pattern and extent of cardiovascular developmental alterations among children conceived by assisted reproductive technology (ART) and its association with potential confounders. The present study was a prospective single-blind pilot design lasting 15 months. The ART group was recruited by a non-random, consecutive sample on the basis of the unique personal identification number assigned to ART children, whereas spontaneous conception controls were recruited by a population-based random sample from the same hospital by age. Echocardiography was available for the measurement of 128 ART children and 100 controls with respect to cardiovascular geometric morphology and cardiac function. The majority of cardiac geometric morphology parameters were comparable among the study groups (P>0.05), except for significant increases in left ventricular (LV) relative wall thickness (P=0.038), LV mass index (P=0.005) and LV remodeling index (P=0.005) in ART children after adjustment for age, gender, body surface area and heart rate. The results showed similarity in LV systolic function characterized by ejection fraction (P=0.140) and shortening fraction (P=0.167) between the groups. However, ART children had a significant tendency toward a decrease in mitral A (P=0.008) and mitral E' (P=0.012) compared with controls after adjusting for confounders. Additionally, Cox analysis suggested an independent association (Pchildren compared with controls, which may be independently associated with the anthropometrics and perinatal outcomes in addition to the ART procedure. © 2014 S. Karger AG, Basel.

  14. Vasopressin versus dopamine for treatment of hypotension in extremely low birth weight infants: a randomized, blinded pilot study.

    Science.gov (United States)

    Rios, Danielle R; Kaiser, Jeffrey R

    2015-04-01

    To evaluate vasopressin vs dopamine as initial therapy in extremely low birth weight (ELBW) infants with hypotension during the first 24 hours of life. ELBW infants with hypertension ≤ 30 weeks' gestation and ≤ 24 hours old randomly received treatment with vasopressin or dopamine in a blinded fashion. Normotensive infants not receiving vasopressor support served as a comparison group. Twenty ELBW infants with hypertension received vasopressin (n = 10) or dopamine (n = 10), and 50 were enrolled for comparison. Mean gestational age was 25.6 ± 1.4 weeks and birth weight 705 ± 154 g. Response to vasopressin paralleled that of dopamine in time to adequate mean blood pressure (Kaplan-Meier curve, P = .986); 90% of infants in each treatment group responded with adequate blood pressure. The vasopressin group received fewer doses of surfactant (P hypotension appeared safe. This pilot study supports a larger randomized controlled trial of vasopressin vs dopamine therapy in ELBW infants with hypotension. Copyright © 2015 Elsevier Inc. All rights reserved.

  15. Molecular profiling of complete congenital stationary night blindness: a pilot study on an Indian cohort.

    Science.gov (United States)

    Malaichamy, Sivasankar; Sen, Parveen; Sachidanandam, Ramya; Arokiasamy, Tharigopala; Lancelot, Marie Elise; Audo, Isabelle; Zeitz, Christina; Soumittra, Nagasamy

    2014-01-01

    Congenital stationary night blindness (CSNB) is a non-progressive retinal disorder that shows genetic and clinical heterogeneity. CSNB is inherited as an autosomal recessive, autosomal dominant, or X-linked recessive trait and shows a good genotype-phenotype correlation. Clinically, CSNB is classified as the Riggs type and the Schubert-Bornschein type. The latter form is further sub-classified into complete and incomplete forms based on specific waveforms on the electroretinogram (ERG). There are no molecular genetic data for CSNB in the Indian population. Therefore, we present for the first time molecular profiling of eight families with complete CSNB (cCSNB). The index patients and their other affected family members were comprehensively evaluated for the phenotype, including complete ophthalmic evaluation, ERG, fundus autofluorescence, optical coherence tomography, and color vision test. The known gene defects for cCSNB, LRIT3, TRPM1, GRM6, GPR179, and NYX, were screened by PCR direct sequencing. Bioinformatic analyses were performed using SIFT and PolyPhen for the identified missense mutations. All eight affected index patients and affected family members were identified as having cCSNB based on their ERG waveforms. Mutations in the TRPM1 gene were identified in six index patients. The two remaining index patients each carried a GPR179 and GRM6 mutation. Seven of the patients revealed homozygous mutations, while one patient showed a compound heterozygous mutation. Six of the eight mutations identified are novel. This is the first report on molecular profiling of candidate genes in CSNB in an Indian cohort. As shown for other cohorts, TRPM1 seems to be a major gene defect in patients with cCSNB in India.

  16. Phellodendron and Citrus extracts benefit joint health in osteoarthritis patients: a pilot, double-blind, placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Chambliss Walter

    2009-08-01

    Full Text Available Abstract Background The objective of this clinical study was to assess the potential benefit of a dietary supplement, NP 06-1, on joint health in overweight and normal weight adults diagnosed with osteoarthritis. Methods An 8-week placebo-controlled, randomized, double-blind study was conducted with four groups comparing the effects of NP 06-1 to placebo on overweight and normal weight subjects diagnosed with primary osteoarthritis of the knee. NP 06-1 (a combination of two botanical extracts; Phellodendron amurense bark and Citrus sinensis peel or matching placebo were given in a dose of two capsules (370 mg each twice daily. The outcome measures were the Lequesne Algofunctional Index (LAI for joint pain and movement as well as biomarkers of inflammation (C-reactive protein [CRP] and erythrocyte sedimentation rate [ESR]. Results Eighty (80 subjects were enrolled and 45 subjects completed the study. No serious adverse events were reported. The mean total LAI scores at baseline for the four groups ranged from 11.4 to 12.4 (SD 1.2 to 2.4. Treatment for 8 weeks resulted in a statistical improvement in the LAI score in the overweight treatment group compared to placebo (6.3 ± 2.3 vs 11.8 ± 1.5; p Conclusion In this pilot study, NP 06-1 had beneficial effects on symptoms of osteoarthritis of the knee as measured using LAI scores and had anti-inflammatory effects as measured using CRP. Administration of NP 06-1 was also associated with weight loss, which may have been a contributing factor to the other benefits.

  17. Evaluation of homoeopathic treatment in polycystic ovary syndrome: A single-blind, randomised, placebo-controlled pilot study

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    Chetna Deep Lamba

    2018-01-01

    Full Text Available Background and Objectives: This study was conducted with the primary objective of evaluating efficacy of Homoeopathy in establishing the menstrual regularity with improvement in either ultrasonological findings or hirsutism/acne. The quality of life was also assessed using polycystic ovary syndrome questionnaire (PCOSQ. Materials and Methods: A single-blind, randomised, placebo-controlled pilot study was conducted from February 2014 to May 2015 at two research centres. The cases fulfilling the eligibility criteria were enrolled (n = 60 and randomised to either the homoeopathic intervention (HI (n = 30 or identical placebo (P (n = 30 with uniform lifestyle modification (LSM for 6 months. Results: The menstrual regularity with improvement in other signs/symptoms was observed in 60% of the cases (n = 18 in HI + LSM group and none (n = 0 in control group (P = 0.001. Statistically significant difference (P = 0.016 was observed in reduction of intermenstrual duration (from 76.1 ± 37.7 to 46.6 ± 38.7 days in HI + LSM in comparison to placebo + LSM group (from 93.0 ± 65.2 to 93.9 ± 96.2 days. In PCOSQ, also, significant improvement was observed in HI group in domains of weight, fertility, emotions and menstrual problems (P < 0.05 with no difference in body hair (P = 0.708. No change was observed in respect of improvement in the ultrasound findings. Pulsatilla was the most frequently indicated medicine (n = 12, 40%. Conclusion: HI along with LSM has shown promising outcome; further comparative study with standard conventional treatment on adequate sample size is desirable.

  18. Effect of myrtle fruit syrup on abnormal uterine bleeding: a randomized double-blind, placebo-controlled pilot study.

    Science.gov (United States)

    Qaraaty, Marzieh; Kamali, Seyed Hamid; Dabaghian, Fataneh Hashem; Zafarghandi, Nafiseh; Mokaberinejad, Roshanak; Mobli, Masumeh; Amin, Gholamreza; Naseri, Mohsen; Kamalinejad, Mohammad; Amin, Mohsen; Ghaseminejad, Azizeh; HosseiniKhabiri, Seyedeh Jihan; Talei, Daryush

    2014-06-02

    Myrtle (Myrtus communis L.) has been used in the Iranian Traditional Medicine as a treatment for abnormal uterine bleeding-menometrorrhagia. The main aim of this study is to evaluate the effect of myrtle fruit syrup on abnormal uterine bleeding-menometrorrhagia. A randomized, double-blind, placebo-controlled pilot study was conducted on 30 women suffering from abnormal uterine bleeding-menometrorrhagia. Treatment comprised of giving 15 ml oral myrtle syrup daily (5 ml three times a day) for 7 days starting from the onset of bleeding. The myrtle syrup along with placebo was repeated for 3 consecutive menstrual periods. Menstrual duration and number of used pads were recorded by the Pictorial Blood loss Assessment Chart at the end of each menstrual period. The quality of life was also evaluated using the menorrhagia questionnaire. The mean number of bleeding days significantly declined from 10.6 ± 2.7 days to 8.2 ± 1.9 days after 3 months treatment with the syrup (p = 0.01) and consequently the participants in the intervention group used fewer pads after 3 months (16.4 ± 10.7) compared with the number of pads used at the beginning of the treatment (22.7 ± 12.0, p = 0.01). Bleeding days and number of pads used by the participants in the placebo group did not change significantly. Also significant changes of quality of life scores were observed in the intervention group after 3 months compared to the baseline. Myrtle syrup is introduced as a potential remedy for abnormal uterine bleeding-menometrorrhagia.

  19. Association of Cardiac Development with Assisted Reproductive Technology in Childhood: A Prospective Single-Blind Pilot Study

    Directory of Open Access Journals (Sweden)

    Jie Zhou

    2014-08-01

    Full Text Available Aims: To examine the pattern and extent of cardiovascular developmental alterations among children conceived by assisted reproductive technology (ART and its association with potential confounders. Methods: The present study was a prospective single-blind pilot design lasting 15 months. The ART group was recruited by a non-random, consecutive sample on the basis of the unique personal identification number assigned to ART children, whereas spontaneous conception controls were recruited by a population-based random sample from the same hospital by age. Echocardiography was available for the measurement of 128 ART children and 100 controls with respect to cardiovascular geometric morphology and cardiac function. Results: The majority of cardiac geometric morphology parameters were comparable among the study groups (P>0.05, except for significant increases in left ventricular (LV relative wall thickness (P=0.038, LV mass index (P=0.005 and LV remodeling index (P=0.005 in ART children after adjustment for age, gender, body surface area and heart rate. The results showed similarity in LV systolic function characterized by ejection fraction (P=0.140 and shortening fraction (P=0.167 between the groups. However, ART children had a significant tendency toward a decrease in mitral A (P=0.008 and mitral E′ (P=0.012 compared with controls after adjusting for confounders. Additionally, Cox analysis suggested an independent association (PConclusion: Our findings support the presence of remodeling in the left cardiac geometric morphology and diastolic dysfunction and the absence of any change to the aortocoronary morphometry or systolic function in ART children compared with controls, which may be independently associated with the anthropometrics and perinatal outcomes in addition to the ART procedure.

  20. The Pakistan national blindness and visual impairment survey--research design, eye examination methodology and results of the pilot study.

    Science.gov (United States)

    Bourne, Rupert; Dineen, Brendan; Jadoon, Zahid; Lee, Pak S; Khan, Aman; Johnson, Gordon J; Foster, Allen; Khan, Daud

    2005-10-01

    To establish age- and sex-specific prevalence rates and causes of blindness and low vision in children aged 10 to 15 years and adults aged 30 years and older in Pakistan. Multi-stage, stratified (rural/urban), cluster random sampling, with probability proportional-to-size procedures, was utilised to select a cross-sectional, nationally representative sample of adults (16,600 subjects) and children (6,000 subjects). Each subject underwent: interview, visual acuity (logMAR), autorefraction and optic disc examination. Those that saw visual acuity and dilated posterior segment examination. The results of a pilot survey are reported in this paper. In the two rural pilot sites, 159 subjects (including 47 children) were examined; 50% were male. Thirty seven adults (23.3%) but no children saw worse than 6/12 in either eye. Two subjects were blind (corrected visual acuity) in the better eye, and 11 were visually impaired. Refractive error was the main cause (in 22 eyes (39% of the total of 56 eyes)) of visual acuity, followed by cataract (12 eyes), uncorrected aphakia (6 eyes) and age-related macular disease (3 eyes). The pilot survey demonstrated that the proposed examination process for the main survey is feasible. Particular strengths of this survey include the use of logMAR visual acuity testing and autorefraction of all subjects, a dilated posterior segment examination, and the use of a 'less than 6/12' threshold for further examination. This lower threshold addresses the burden of refractive error, which, with cataract, are two of the diseases specifically targeted by Vision 2020.

  1. Office worker response to an automated venetian blind and electric lighting system: A pilot study

    Energy Technology Data Exchange (ETDEWEB)

    Vine, E.; Lee, E.; Clear, R.; DiBartolomeo, D.; Selkowitz, S.

    1998-03-01

    A prototype integrated, dynamic building envelope and lighting system designed to optimize daylight admission and solar heat gain rejection on a real-time basis in a commercial office building is evaluated. Office worker response to the system and occupant-based modifications to the control system are investigated to determine if the design and operation of the prototype system can be improved. Key findings from the study are: (1) the prototype integrated envelope and lighting system is ready for field testing, (2) most office workers (N=14) were satisfied with the system, and (3) there were few complaints. Additional studies are needed to explain how illuminance distribution, lighting quality, and room design can affect workplans illuminance preferences.

  2. Randomized, Placebo-Controlled, Double-Blind Pilot Study of D-Cycloserine in Chronic Stroke

    Directory of Open Access Journals (Sweden)

    Andrew J. Butler

    2015-01-01

    Full Text Available Stroke is a leading cause of death and disability in the USA. Up to 60% of patients do not fully recover despite intensive physical therapy treatment. N-Methyl-D-aspartate receptors (NMDA-R have been shown to play a role in synaptic plasticity when activated. D-Cycloserine promotes NMDA receptor function by binding to receptors with unoccupied glycine sites. These receptors are involved in learning and memory. We hypothesized that D-cycloserine, when combined with robotic-assisted physiotherapy (RAP, would result in greater gains compared with placebo + RAP in stroke survivors. Participants (n=14 were randomized to D-cycloserine plus RAP or placebo plus RAP. Functional, cognitive, and quality-of-life measures were used to assess recovery. There was significant improvement in grip strength of the affected hand within both groups from baseline to 3 weeks (95% confidence interval for mean change, 3.95 ± 2.96 to 4.90 ± 3.56 N for D-cycloserine and 5.72 ± 3.98 to 8.44 ± 4.90 N for control. SIS mood domain showed improvement for both groups (95% confidence interval for mean change, 72.6 ± 16.3 to 82.9 ± 10.9 for D-cycloserine and 82.9 ± 13.5 to 90.3 ± 9.9 for control. This preliminary study does not provide evidence that D-cycloserine can provide greater gains in learning compared with placebo for stroke survivors.

  3. Directional deep brain stimulation: an intraoperative double-blind pilot study.

    Science.gov (United States)

    Pollo, Claudio; Kaelin-Lang, Alain; Oertel, Markus F; Stieglitz, Lennart; Taub, Ethan; Fuhr, Peter; Lozano, Andres M; Raabe, Andreas; Schüpbach, Michael

    2014-07-01

    Deep brain stimulation of different targets has been shown to drastically improve symptoms of a variety of neurological conditions. However, the occurrence of disabling side effects may limit the ability to deliver adequate amounts of current necessary to reach the maximal benefit. Computed models have suggested that reduction in electrode size and the ability to provide directional stimulation could increase the efficacy of such therapies. This has never been demonstrated in humans. In the present study, we assess the effect of directional stimulation compared to omnidirectional stimulation. Three different directions of stimulation as well as omnidirectional stimulation were tested intraoperatively in the subthalamic nucleus of 11 patients with Parkinson's disease and in the nucleus ventralis intermedius of two other subjects with essential tremor. At the trajectory chosen for implantation of the definitive electrode, we assessed the current threshold window between positive and side effects, defined as the therapeutic window. A computed finite element model was used to compare the volume of tissue activated when one directional electrode was stimulated, or in case of omnidirectional stimulation. All but one patient showed a benefit of directional stimulation compared to omnidirectional. A best direction of stimulation was observed in all the patients. The therapeutic window in the best direction was wider than the second best direction (P = 0.003) and wider than the third best direction (P = 0.002). Compared to omnidirectional direction, the therapeutic window in the best direction was 41.3% wider (P = 0.037). The current threshold producing meaningful therapeutic effect in the best direction was 0.67 mA (0.3-1.0 mA) and was 43% lower than in omnidirectional stimulation (P = 0.002). No complication as a result of insertion of the directional electrode or during testing was encountered. The computed model revealed a volume of tissue activated of 10.5 mm(3) in

  4. Phellodendron and Citrus extracts benefit cardiovascular health in osteoarthritis patients: a double-blind, placebo-controlled pilot study

    Directory of Open Access Journals (Sweden)

    Chambliss Walter

    2008-05-01

    Full Text Available Abstract Background The objective of this clinical study was to assess the potential benefit of a dietary supplement, NP 06-1, on cardiovascular protective properties in overweight and normal weight adults diagnosed with osteoarthritis of the knee. Methods An 8-week, placebo-controlled, randomized, double-blind study was conducted with four groups, comparing the effects of NP 06-1 to placebo in overweight and normal weight subjects diagnosed with primary osteoarthritis of the knee. NP 06-1 (a combination of two botanical extracts; Phellodendron amurense bark and Citrus sinensis peel or matching placebo was given in a dose of two capsules (370 mg each twice daily. The outcome measures reported are lipid levels, weight, BMI, blood pressure and fasting glucose. Analyses of variance were used to compare changes of physiological measures over the trial period and between groups. Results Eighty (80 subjects were enrolled and 45 subjects completed the study. No serious adverse events were reported. NP 06-1 administration was associated with a general improvement in lipid levels. Both the overweight and normal weight treatment groups had significant reductions in triglycerides and LDL-cholesterol, as well as a significant increase in HDL-cholesterol compared to their respective control groups. Overall there were decreases in blood pressure in both overweight and normal weight treatment groups compared to respective placebo groups. There was also a significant decrease in fasting glucose levels in the overweight treatment group compared to the start of the study and to the overweight placebo group. There was no change in fasting blood sugar for the normal weight groups. Both overweight and normal weight treatment groups lost a significant amount of weight compared to their respective placebo groups. The overweight treatment group lost an average of 5% body weight after 8 weeks, which was associated with a significant loss in BMI over time. Conclusion In

  5. 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.

    2014-01-01

    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. PMID:25008086

  6. 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.

  7. A prospective placebo-controlled double-blind trial of antibiotic prophylaxis in intraoral bone grafting procedures: A pilot study

    NARCIS (Netherlands)

    Lindeboom, Jerome A. H.; van den Akker, Hans P.

    2003-01-01

    Objective. A pilot study was conducted to assess the efficacy of a single-dose preoperative prophylactic of the penicillin pheneticillin compared with placebo in the antibiotic prophylaxis of surgical wound infections in intra-oral bone grafting procedures. Patients and Methods. Twenty patients (age

  8. Effects of Suspended Moxibustion on Delayed Onset Muscle Soreness: A Randomized Controlled Double-Blind Pilot Study

    OpenAIRE

    Ding Meng, Dong Xiaosheng, Wang Xuhui, Wang Xu, Zhang Xijin

    2017-01-01

    The objective of this study was to investigate the effects of suspended moxibustion upon tender point on delayed onset muscle soreness. The study was a randomized double-blind controlled trial with 50 subjects in each group. Subjects in moxibustion group received suspended moxibustion upon tender point (by palpation) twice. The controls received no treatment. Each subject received treatments twice, 24 hr and 48 hr after the delayed onset muscle soreness induction. The measurements of Pain Vis...

  9. 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.

  10. The MOTIV-HEART Study: A Prospective, Randomized, Single-Blind Pilot Study of Brief Strategic Therapy and Motivational Interviewing among Cardiac Rehabilitation Patients.

    Science.gov (United States)

    Pietrabissa, Giada; Manzoni, Gian Mauro; Rossi, Alessandro; Castelnuovo, Gianluca

    2017-01-01

    Background: Psychological distress, biomedical parameters, and unhealthy lifestyles contribute to a poorer prognosis for cardiac disease. Public health's challenge is to motivate patients to utilize self-care. Objective: This prospective, randomized, single-blind pilot study aimed at testing the incremental efficacy of Brief Strategic Therapy (BST) combined with Motivational Interviewing (MI) in improving selected biomedical and psychological outcomes over and beyond those of the stand-alone BST in a residential Cardiac Rehabilitation (CR) program. Method: Fourty-two inpatients (17 females), enrolled in a 1-month CR program, were randomly allocated into two conditions: (a) Three sessions of BST and (b) Three sessions of BST plus MI. Data were collected at baseline, discharge, and after 3 months through phone interviews. Results: At discharge, no significant between-group difference was found in any outcome variable. Changes from pre- to post-treatment within each condition showed significant improvements only in the BST group, where the level of external regulation diminished, and both the participants' self-regulation (Relative Autonomous Motivation Index, RAI) and willingness to change improved. At the 3-month follow-up, within-group analyses on responders (BST = 9; BST + MI = 11) showed a statistically significant improvement in the level of systolic blood pressure in both groups. Discussion: Findings showed no evidence of the incremental efficacy of combining BST and MI over and beyond BST alone on either selected biomedical or psychological outcomes among CR patients. Conclusions: Ends and limitations from the present pilot study should be considered and addressed in future investigations.

  11. The MOTIV-HEART Study: A Prospective, Randomized, Single-Blind Pilot Study of Brief Strategic Therapy and Motivational Interviewing among Cardiac Rehabilitation Patients

    Science.gov (United States)

    Pietrabissa, Giada; Manzoni, Gian Mauro; Rossi, Alessandro; Castelnuovo, Gianluca

    2017-01-01

    Background: Psychological distress, biomedical parameters, and unhealthy lifestyles contribute to a poorer prognosis for cardiac disease. Public health's challenge is to motivate patients to utilize self-care. Objective: This prospective, randomized, single-blind pilot study aimed at testing the incremental efficacy of Brief Strategic Therapy (BST) combined with Motivational Interviewing (MI) in improving selected biomedical and psychological outcomes over and beyond those of the stand-alone BST in a residential Cardiac Rehabilitation (CR) program. Method: Fourty-two inpatients (17 females), enrolled in a 1-month CR program, were randomly allocated into two conditions: (a) Three sessions of BST and (b) Three sessions of BST plus MI. Data were collected at baseline, discharge, and after 3 months through phone interviews. Results: At discharge, no significant between-group difference was found in any outcome variable. Changes from pre- to post-treatment within each condition showed significant improvements only in the BST group, where the level of external regulation diminished, and both the participants' self-regulation (Relative Autonomous Motivation Index, RAI) and willingness to change improved. At the 3-month follow-up, within-group analyses on responders (BST = 9; BST + MI = 11) showed a statistically significant improvement in the level of systolic blood pressure in both groups. Discussion: Findings showed no evidence of the incremental efficacy of combining BST and MI over and beyond BST alone on either selected biomedical or psychological outcomes among CR patients. Conclusions: Ends and limitations from the present pilot study should be considered and addressed in future investigations. PMID:28223950

  12. Foot Reflexotherapy Induces Analgesia in Elderly Individuals with Low Back Pain: A Randomized, Double-Blind, Controlled Pilot Study

    Directory of Open Access Journals (Sweden)

    Bruna Hoffmann de Oliveira

    2017-01-01

    Full Text Available Introduction. This study evaluated the effects of foot reflexotherapy on pain and postural balance in elderly individuals with low back pain. Design. Randomized, controlled pilot study. Participants (n=20 were randomly assigned to 2 groups: individuals submitted to conventional foot massage (control group or foot reflexotherapy (RT, intervention group for a period of 5 weeks. Questionnaires on pain and disability (visual analogue scale [VAS] and Roland-Morris Disability Questionnaire [RMDQ], heart rate variability, and orthostatic balance and baropodometric analysis were assessed at two intervals: before and after intervention. Results. RT group showed statistically significant differences when compared to control group in the following parameters: decrease in VAS scores for pain throughout the study, decrease in parasympathetic activity, and improvement in RMDQ scores. The two groups did not statistically differ in either orthostatic balance or baropodometric analyses. Conclusion. This study demonstrated that foot reflexotherapy induced analgesia but did not affect postural balance in elderly individuals with low back pain.

  13. Intravaginal and intracervical application of seminal plasma in in vitro fertilization or intracytoplasmic sperm injection treatment cycles--a double-blind, placebo-controlled, randomized pilot study.

    Science.gov (United States)

    von Wolff, Michael; Rösner, Sabine; Thöne, Christina; Pinheiro, Rafael Mota; Jauckus, Julia; Bruckner, Thomas; Biolchi, Vanderleyen; Alia, Amal; Strowitzki, Thomas

    2009-01-01

    To evaluate whether intravaginal application of seminal plasma at the time of follicle aspiration in IVF or intracytoplasmic sperm injection treatment cycles has the potential to increase pregnancy rate. To calculate the number of patients needed to achieve significance in a multicenter trial. Double-blind, placebo-controlled randomized pilot study. University department of gynecological endocrinology and reproductive medicine. One hundred sixty-eight patients undergoing IVF or intracytoplasmic sperm injection treatment. Cryopreserved seminal plasma from the patient's partner or sodium chloride (placebo) was injected into the cervix and the posterior fornix of the vagina just after follicle aspiration. Clinical-pregnancy rate. One hundred sixty-eight patients agreed to participate in the study. Participation was limited to one treatment cycle. Thirty-one patients (18%) were excluded from the study, mainly as a result of canceled embryo transfers. Seventy patients received placebo, and 67 received seminal plasma. The clinical-pregnancy rate was 25.7% (18/70) in the placebo group. The clinical-pregnancy rate in the seminal plasma group reached 37.3% (25/67), corresponding to a relative increase of 45%. Even though significance was not reached in this pilot study, the data suggest that seminal plasma has the potential to improve pregnancy rate. It is estimated that around 450 patients need to be recruited to reach significance in a multicenter study.

  14. Efficacy and safety of Citrus sudachi peel in obese adults: A randomized, double-blind, pilot study

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    Masashi Akaike

    2014-07-01

    Full Text Available Objective: This study was undertaken to explore the efficacy and safety of Citrus sudachi peel for metabolic risk factors in obese male and female adults. Background: Citrus sudachi Hort. ex Shirai (Rutaceae, called “sudachi”, is a small, round, green citrus fruit that is mainly cultivated in Tokushima Prefecture in Japan. Our group reported that Citrus sudachi peel powder improved glucose tolerance and dyslipidemia in Zucher-fatty rats and reduced hyperglycemia and hypertriglyceridemia in GK diabetic rats. Materials and Methods: We conducted a randomized, double-blind, placebo-controlled trial in 40 participants with abdominal obesity and metabolic risk factors including hypertension, impaired glucose tolerance and elevated triglyceride levels. Participants were randomized to receive either tablets that contained 1.3 g dried Citrus sudachi peel powder or placebo tablets for 12 weeks. The sudachi peel group included 14 males and 5 females with a mean age of 54.5 years, and the placebo group included 18 males and 2 females with a mean age of 51.9 years. Results: Physical status including body weight, waist circumference and blood pressure and laboratory markers including metabolic parameters were not different at any observation point between the two groups. However, among participants with serum triglyceride levels of more than 120 mg/dl, body weight, waist circumference and serum triglyceride levels were significantly decreased at several observation points after the start of treatment in the sudachi peel group but not in the placebo group. No serious adverse events were observed in the sudachi peel group. Conclusions: Citrus sudachi peel has the potential effect to safely improve abdominal obesity and lower serum levels of TG in obese individuals with hypertriglyceridemia. A large-scale randomized, double-blind clinical study targeting subjects with both abdominal obesity and high TG levels is needed to confirm the metabolic effects of

  15. Immediate effects after stochastic resonance whole-body vibration on physical performance on frail elderly for skilling-up training: a blind cross-over randomised pilot study.

    Science.gov (United States)

    Rogan, Slavko; Schmidtbleicher, Dietmar; Radlinger, Lorenz

    2014-10-01

    This pilot study examined the feasibility outcome recruitment, safety and compliance of the investigation for stochastic resonance whole-body vibration (SR-WBV) training. Another aim was to evaluate the effect size of one SR-WBV intervention session on Short Physical Performance Battery (SPPB), Expanded Timed Get Up-and-Go (ETGUG), isometric maximal voluntary contraction (IMVC) and rate of force development (IRFD) and chair rising (CR). Randomised double-blinded controlled cross-over pilot study. Feasibility outcomes included recruitment, safety and compliance. For secondary outcomes, SPPB, ETGUG, IMVC, IRFD and CR were measured before and 2-min after intervention. Nonparametric Rank-Order Tests of Puri and Sen L Statistics to Ranked Data were proposed. Wilcoxon signed-ranked tests were used to analyse the differences after SR-WBV intervention and sham intervention. Treatment effects between the interventions were compared by a Mann-Whitney U test. Among 24 eligible frail elderly, 12 agreed to participate and 3 drop out. The adherence was 15 of 24 intervention sessions. For secondary outcome, effect sizes (ES) for SR-WBV intervention on SPPB, ETGUG and CR were determined. This pilot study indicate that the training protocol used in this form for frail elderly individuals is feasible but with modification due to the fact that not all defined feasibility outcomes target was met. SR-WBV with 6 Hz, noise level 4 shows benefit improvements on SPPB (ES 0.52), ETGUG (part sit-to-stand movement: ES 0.81; total time: ES 0.85) and CR (ES 0.66). Further research is desired to determine whether a new adapted training protocol is necessary for SR-WBV in the "skilling up" phase in frail elderly individuals.

  16. BEMER Therapy Combined with Physiotherapy in Patients with Musculoskeletal Diseases: A Randomised, Controlled Double Blind Follow-Up Pilot Study

    Directory of Open Access Journals (Sweden)

    Franciska Gyulai

    2015-01-01

    Full Text Available Background. This study evaluates the effect of adjuvant BEMER therapy in patients with knee arthrosis and chronic low back pain in a randomized double blind design. Methods. A total of 50 patients with chronic low back pain and 50 patients with osteoarthritis of knee took part in this study and were randomized into 4 groups. Hospitalized patients received a standardized physiotherapy package for 3 weeks followed by BEMER therapy or placebo. Results. In patients with low back pain, the comparison of the results obtained at the first and second visit showed a significant improvement in resting VAS scores and Fatigue Scale scores. The Oswestry scores and Quality of Life Scale scores showed no change. In patients with knee arthrosis, the comparison of the first and second measurements showed no significant improvement in the abovementioned parameters, while the comparison of the first and third scores revealed a significant improvement in the Fatigue Scale scores and in the vitality test on the Quality of Life Scale. Conclusions. Our study showed that BEMER physical vascular therapy reduced pain and fatigue in the short term in patients with chronic low back pain, while long-term therapy appears to be beneficial in patients with osteoarthritis of knee.

  17. Mirtazapine does not improve sleep disorders in Alzheimer's disease: results from a double-blind, placebo-controlled pilot study.

    Science.gov (United States)

    Scoralick, Francisca M; Louzada, Luciana L; Quintas, Juliana L; Naves, Janeth O S; Camargos, Einstein F; Nóbrega, Otávio T

    2017-03-01

    The aim of this study was to test the efficacy and safety of mirtazapine in the treatment of sleep disorders in patients with Alzheimer's disease by means of a randomized, double-blind, placebo-controlled trial. Measurements were obtained for 7 days before intervention (baseline) and for 2 weeks after the onset of treatment. Alzheimer's disease patients with sleep disorders (n = 24) received 15-mg mirtazapine (n = 8) or placebo (n = 16) once daily at 2100 hours for 2 weeks. Patients were evaluated with actigraphy and structured scales before and after intervention. Historical control was employed. Treatment with mirtazapine or placebo had no effect on cognitive and functional status as assessed by the Mini-Mental State Examination and the Katz scale, respectively. There were no differences between groups in the frequency or severity of the adverse events reported. Compared with the placebo group, mirtazapine users showed increased daytime sleepiness but no improvement in the duration or efficiency of nocturnal sleep after treatment. This study showed no significant therapeutic effects of 15-mg mirtazapine in community-dwelling Alzheimer's disease patients with sleep disorders. Instead, this study found evidence of worsening of daytime sleep patterns. © 2016 The Authors. Psychogeriatrics © 2016 Japanese Psychogeriatric Society.

  18. Atomoxetine treatment for nicotine withdrawal: a pilot double-blind, placebo-controlled, fixed-dose study in adult smokers

    Directory of Open Access Journals (Sweden)

    Silverstone Peter H

    2012-03-01

    Full Text Available Abstract Background Many effective treatments for nicotine addiction inhibit noradrenaline reuptake. Three recent studies have suggested that another noradrenaline reuptake inhibitor, atomoxetine, may reduce smoking behaviors. Methods The present double-blind, placebo-controlled, fixed-dose study was carried out over 21 days during which administration of 40 mg atomoxetine was compared to placebo in 17 individuals. Of these, nine were randomized to atomoxetine and eight to placebo. Baseline and weekly measurements were made using the Cigarette Dependence Scale (CDS, Cigarette Withdrawal Scale (CWS, Questionnaire of Smoking Urges (QSU, reported number of cigarettes smoked, and salivary cotinine levels. Results The study results showed that all those on placebo completed the study. In marked contrast, of the nine individuals who started on atomoxetine, five dropped out due to side effects. In a completer analysis there were statistically significant differences at 14 and 21 days in several measures between the atomoxetine and placebo groups, including CDS, CWS, QSU, number of cigarettes smoked (decreasing to less than two per day in the treatment group who completed the study, and a trend towards lower mean salivary cotinine levels. However, these differences were not seen in a last observation carried forward (LOCF analysis. Conclusions In summary, this is the first study to examine the use of atomoxetine in non-psychiatric adult smokers for a period of more than 7 days, and the findings suggest that atomoxetine might be a useful treatment for nicotine addiction. However, the dose used in the current study was too high to be tolerated by many adults, and a dose-finding study is required to determine the most appropriate dose for future studies of this potential treatment for smoking cessation.

  19. Curcumin as an add-on to antidepressive treatment: a randomized, double-blind, placebo-controlled, pilot clinical study.

    Science.gov (United States)

    Bergman, Joseph; Miodownik, Chanoch; Bersudsky, Yuly; Sokolik, Shmuel; Lerner, Paul P; Kreinin, Anatoly; Polakiewicz, Jacob; Lerner, Vladimir

    2013-01-01

    Depression is a widespread mental disorder in which nearly half of the affected people have recurrent symptoms. Drug combinations may produce cumulative adverse effects, especially in elderly and physically ill patients. It was demonstrated that curcumin possesses antidepressive activity in various animal models of depression, and a combination of curcumin with some antidepressants potentiates the antidepressive effect of these agents. We sought to evaluate the efficacy of curcumin as an antidepressive agent in a combination with other antidepressants in patients with major depression. Forty patients with a first episode of depression participated in a 5-week, double-blind, randomized, placebo-controlled study. The subjects were treated with either 500-mg/d curcumin or placebo together with antidepressants (escitalopram or venlafaxine) during August 2010 until June 2011. The outcome measures were Clinical Global Impression-Severity Scale, Hamilton Depression Rating Scale, and Montgomery-Asberg Depression Rating Scale. Analysis of variance showed significant positive changes in both groups from baseline to the end of the study in all scales of measurement. These changes became significant from the first visit after 7 days of treatment. There was no difference between curcumin and placebo, which means negative results. However, the patients in the curcumin group demonstrated a trend to a more rapid relief of depressive symptoms in comparison to those in the placebo group. None of the patients complained of any adverse effect during the study. Although there is no definitive proof that curcumin can induce an earlier beneficial effect of antidepressive agents, it seems like an extended study is needed to prove it, using higher therapeutic doses of curcumin.

  20. Effect of a Protein Supplement on the Gut Microbiota of Endurance Athletes: A Randomized, Controlled, Double-Blind Pilot Study

    Directory of Open Access Journals (Sweden)

    Diego Moreno-Pérez

    2018-03-01

    Full Text Available Nutritional supplements are popular among athletes to improve performance and physical recovery. Protein supplements fulfill this function by improving performance and increasing muscle mass; however, their effect on other organs or systems is less well known. Diet alterations can induce gut microbiota imbalance, with beneficial or deleterious consequences for the host. To test this, we performed a randomized pilot study in cross-country runners whose diets were complemented with a protein supplement (whey isolate and beef hydrolysate (n = 12 or maltodextrin (control (n = 12 for 10 weeks. Microbiota, water content, pH, ammonia, and short-chain fatty acids (SCFAs were analyzed in fecal samples, whereas malondialdehyde levels (oxidative stress marker were determined in plasma and urine. Fecal pH, water content, ammonia, and SCFA concentrations did not change, indicating that protein supplementation did not increase the presence of these fermentation-derived metabolites. Similarly, it had no impact on plasma or urine malondialdehyde levels; however, it increased the abundance of the Bacteroidetes phylum and decreased the presence of health-related taxa including Roseburia, Blautia, and Bifidobacterium longum. Thus, long-term protein supplementation may have a negative impact on gut microbiota. Further research is needed to establish the impact of protein supplements on gut microbiota.

  1. INTRANASAL ADMINSITRATION OF OXYTOCIN IN POSTNATAL DEPRESSION: IMPLICATIONS FOR PSYCHODYNAMIC PSYCHOTHERAPY FROM A RANDOMIZED DOUBLE-BLIND PILOT STUDY

    Directory of Open Access Journals (Sweden)

    Andrea eCLARICI

    2015-04-01

    Full Text Available Oxytocin is a neuropeptide that is active in the central nervous system and is generally considered to be involved in prosocial behaviors and feelings. In light of its documented positive effect on maternal behaviour, we designed a study to ascertain whether oxytocin exerts any therapeutic effects on depressive symptoms in women affected by maternal postnatal depression. A group of 16 mothers were recruited in a randomized double-blind study: the women agreed to take part in a brief course of psychoanalytic psychotherapy (12 sessions, once a week while also being administered, during the 12-week period, with a daily dose of intranasal oxytocin (or a placebo. The pre-treatment evaluation also included a personality assessment of the major primary-process emotional command systems described by Panksepp (1998 and a semi-quantitative assessment by the therapist of the mother’s depressive symptoms and on her personality. No significant effect on depressive symptomatology was found following the administration of oxytocin (as compared to a placebo during the period of psychotherapy. Nevertheless, a personality trait evaluation of the mothers, conducted in our overall sample group, showed a decrease in the narcissistic trait only within the group who took oxytocin. The depressive (dysphoric trait was in fact significantly affected by psychotherapy (this effect was only present in the placebo group so it may reflect a positive placebo effect enhancing the favorable influence of psychotherapy on depressive symptoms but not in the presence of oxytocin. Based on these results, we confirm our hypothesis that what is generally defined as postnatal depression may include disturbances of narcissistic affective balance, and oxytocin supplementation can counteract that type of affective disturbance.

  2. Brief Report: Pilot Single-Blind Placebo Lead-in Study of Acamprosate in Youth with Autistic Disorder

    Science.gov (United States)

    Erickson, Craig A.; Wink, Logan K.; Early, Maureen C.; Stiegelmeyer, Elizabeth; Mathieu-Frasier, Lauren; Patrick, Vanessa; McDougle, Christopher J.

    2014-01-01

    Rationale: An excitatory/inhibitory (E:I) imbalance marked by enhanced glutamate and deficient gamma-aminobutyric acid (GABA) neurotransmission may contribute to the pathophysiology of autism spectrum disorders (ASD). Objectives: We report on the first single-blind placebo lead-in trial of acamprosate, a drug with putative mechanisms restoring E:I…

  3. Double-Blind, Placebo-Controlled Pilot Study of Processed Ultra Emu Oil Versus Placebo in the Prevention of Radiation Dermatitis

    Energy Technology Data Exchange (ETDEWEB)

    Rollmann, Denise C. [Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota (United States); Novotny, Paul J. [Division of Biomedical Informatics and Biostatistics, Mayo Clinic, Rochester, Minnesota (United States); Petersen, Ivy A.; Garces, Yolanda I.; Bauer, Heather J.; Yan, Elizabeth S. [Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota (United States); Wahner-Roedler, Dietlind; Vincent, Ann [Department of General Internal Medicine, Mayo Clinic, Rochester, Minnesota (United States); Sloan, Jeff A. [Division of Biomedical Informatics and Biostatistics, Mayo Clinic, Rochester, Minnesota (United States); Issa Laack, Nadia N., E-mail: laack.nadia@mayo.edu [Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota (United States)

    2015-07-01

    Purpose: The purpose of this single-institution pilot study was to evaluate the feasibility and safety of an oil-based skin agent, Ultra Emu Oil, on skin-related toxicity in patients undergoing radiation therapy to the breast or chest wall. Methods and Materials: Patients were randomized 2:1 in a double-blind fashion and were instructed to apply processed Ultra Emu Oil or placebo (cottonseed oil) twice daily during the course of radiation therapy. The oils were applied before the third fraction and continued for 6 weeks after completion of treatment. The primary endpoint was the area under the curve (AUC) of Skindex-16 scale scores over time. Secondary outcomes included maximum grade of radiation dermatitis using the Common Terminology Criteria (CTC) for Adverse Events (CTCAE 3.0), the Skin Toxicity Assessment Tool, quality of life (QOL) measured by Linear Analogue Self-Assessment, and a symptom experience diary (SED). Results: In all, 42 of 45 patients completed the study and were evaluable. The median times to peak rash, skin redness, peeling, and skin swelling were weeks 6, 6, 7, and 7, respectively as measured by the SED. The Skindex AUC scores tended to be lower in emu oil patients than in placebo patients (mean total AUC 7.2 vs 10.4, respectively). This trend was also seen in all the Skindex subdomains. The overall QOL was slightly better in the emu oil group but remained stable throughout the study for both arms. Peak CTC toxicity occurred at week 6. Patients using emu oil appeared slightly worse on maximum CTC grade, but the difference was not significant. Conclusions: This pilot study confirmed the safety of oil-based skin treatments during radiation therapy and suggests a trend for reduced skin toxicity for patients receiving emu oil. A larger study is needed to evaluate the efficacy of emu oil in reducing radiation dermatitis in patients receiving breast radiation.

  4. Double-Blind, Placebo-Controlled Pilot Study of Processed Ultra Emu Oil Versus Placebo in the Prevention of Radiation Dermatitis

    International Nuclear Information System (INIS)

    Rollmann, Denise C.; Novotny, Paul J.; Petersen, Ivy A.; Garces, Yolanda I.; Bauer, Heather J.; Yan, Elizabeth S.; Wahner-Roedler, Dietlind; Vincent, Ann; Sloan, Jeff A.; Issa Laack, Nadia N.

    2015-01-01

    Purpose: The purpose of this single-institution pilot study was to evaluate the feasibility and safety of an oil-based skin agent, Ultra Emu Oil, on skin-related toxicity in patients undergoing radiation therapy to the breast or chest wall. Methods and Materials: Patients were randomized 2:1 in a double-blind fashion and were instructed to apply processed Ultra Emu Oil or placebo (cottonseed oil) twice daily during the course of radiation therapy. The oils were applied before the third fraction and continued for 6 weeks after completion of treatment. The primary endpoint was the area under the curve (AUC) of Skindex-16 scale scores over time. Secondary outcomes included maximum grade of radiation dermatitis using the Common Terminology Criteria (CTC) for Adverse Events (CTCAE 3.0), the Skin Toxicity Assessment Tool, quality of life (QOL) measured by Linear Analogue Self-Assessment, and a symptom experience diary (SED). Results: In all, 42 of 45 patients completed the study and were evaluable. The median times to peak rash, skin redness, peeling, and skin swelling were weeks 6, 6, 7, and 7, respectively as measured by the SED. The Skindex AUC scores tended to be lower in emu oil patients than in placebo patients (mean total AUC 7.2 vs 10.4, respectively). This trend was also seen in all the Skindex subdomains. The overall QOL was slightly better in the emu oil group but remained stable throughout the study for both arms. Peak CTC toxicity occurred at week 6. Patients using emu oil appeared slightly worse on maximum CTC grade, but the difference was not significant. Conclusions: This pilot study confirmed the safety of oil-based skin treatments during radiation therapy and suggests a trend for reduced skin toxicity for patients receiving emu oil. A larger study is needed to evaluate the efficacy of emu oil in reducing radiation dermatitis in patients receiving breast radiation

  5. Proprietary arabinogalactan extract increases antibody response to the pneumonia vaccine: a randomized, double-blind, placebo-controlled, pilot study in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Udani Jay K

    2010-08-01

    Full Text Available Abstract Background Arabinogalactan from Larch tree (Larix spp. bark has previously demonstrated immunostimulatory activity. The purpose of this study was to test the hypothesis that ingestion of a proprietary arabinogalactan extract, ResistAid™, would selectively enhance the antibody response to the pneumococcal (pneumonia vaccine in healthy adults. Methods This randomized, double-blind, placebo-controlled, parallel group pilot study included 45 healthy adults who had not previously been vaccinated against Streptococcus pneumoniae. The volunteers began taking the study product or placebo (daily dosage 4.5 g at the screening visit (V1-Day 0 and continued over the entire 72 day study period. After 30 days the subjects received the 23-valent pneumococcal vaccine (V2. They were monitored the following day (V3-Day 31, as well as 21 days (V4-Day 51 and 42 days (V5-Day 72 after vaccination. Responses by the adaptive immune system (antigen specific were measured via pneumococcal IgG antibodies (subtypes 4, 6B, 9V, 14, 18C, 19F, and 23F and salivary IgA levels. Responses by the innate immune system (non-specific were measured via white blood cell counts, inflammatory cytokines and the complement system. Results Vaccination significantly increased pneumococcal IgG levels as expected. The arabinogalactan group demonstrated a statistically significant greater IgG antibody response than the placebo group in two antibodies subtypes (18C and 23F at both Day 51 (p = 0.006 and p = 0.002 and at Day 72 (p = 0.008 and p = 0.041. These same subtypes (18C and 23F also demonstrated change scores from baseline which were significant, in favor of the arabinogalactan group, at Day 51 (p = 0.033 and 0.001 and at Day 72 (p = 0.012 and p = 0.003. Change scores from baseline and mean values were greater in the arabinogalactan group than placebo for most time points in antibody subtypes 4, 6B, 9V, and 19F, but these differences did not reach statistical significance. There

  6. A double-blind, randomized, pilot dose-finding study of maca root (L. meyenii) for the management of SSRI-induced sexual dysfunction.

    Science.gov (United States)

    Dording, Christina M; Fisher, Lauren; Papakostas, George; Farabaugh, Amy; Sonawalla, Shamsah; Fava, Maurizio; Mischoulon, David

    2008-01-01

    We sought to determine whether maca, a Peruvian plant, is effective for selective-serotonin reuptake inhibitor (SSRI)-induced sexual dysfunction. We conducted a double-blind, randomized, parallel group dose-finding pilot study comparing a low-dose (1.5 g/day) to a high-dose (3.0 g/day) maca regimen in 20 remitted depressed outpatients (mean age 36+/-13 years; 17 women) with SSRI-induced sexual dysfunction. The Arizona Sexual Experience Scale (ASEX) and the Massachusetts General Hospital Sexual Function Questionnaire (MGH-SFQ) were used to measure sexual dysfunction. Ten subjects completed the study, and 16 subjects (9 on 3.0 g/day; 7 on 1.5 g/day) were eligible for intent-to-treat (ITT) analyses on the basis of having had at least one postbaseline visit. ITT subjects on 3.0 g/day maca had a significant improvement in ASEX (from 22.8+/-3.8 to 16.9+/-6.2; z=-2.20, P=0.028) and in MGH-SFQ scores (from 24.1+/-1.9 to 17.0+/-5.7; z=-2.39, P=0.017), but subjects on 1.5 g/day maca did not. Libido improved significantly (PMaca was well tolerated. Maca root may alleviate SSRI-induced sexual dysfunction, and there may be a dose-related effect. Maca may also have a beneficial effect on libido.

  7. In Vitro Activation of eNOS by Mangifera indica (Careless™) and Determination of an Effective Dosage in a Randomized, Double-Blind, Human Pilot Study on Microcirculation.

    Science.gov (United States)

    Gerstgrasser, Alexandra; Röchter, Sigrid; Dressler, Dirk; Schön, Christiane; Reule, Claudia; Buchwald-Werner, Sybille

    2016-03-01

    Mangifera indica fruit preparation (Careless™) activates the evolutionary conserved metabolic sensors sirtuin 1 and adenosine monophosphate-activated protein kinase, which have been identified as playing a key role in microcirculation and endothelial function. Here, an acute effect of a single dose of 100 mg or 300 mg Careless™ on microcirculation was investigated in a randomized, double-blind, crossover pilot study in ten healthy women to determine the effective dosage. Microcirculation and endothelial function were assessed by the Oxygen-to-see system and pulse amplitude tonometry (EndoPAT™), respectively. Cutaneous blood flow was increased over time by 100 mg (54% over pre-values, p = 0.0157) and 300 mg (35% over pre-value, p = 0.209) Careless™. The EndoPAT™ reactive hyperemia response was slightly improved 3 h after intake compared to pretesting with 300 mg Careless™. Furthermore, activation of endothelial nitric oxide synthase, as an important regulator for endothelial function, was tested in vitro in primary human umbilical vein endothelial cells. Careless™, after simulation of digestion, increased the activated form of endothelial nitric oxide synthase dose-dependently by 23% (300 µg/mL), 42% (1500 µg/mL), and 60% (3000 µg/mL) compared to the untreated control. In conclusion, the study suggests moderate beneficial effects of Careless™ on microcirculation, which is at least partly mediated by endothelial nitric oxide synthase activation. Georg Thieme Verlag KG Stuttgart · New York.

  8. Adjuvant antifungal therapy using tissue tolerable plasma on oral mucosa and removable dentures in oral candidiasis patients: a randomised double-blinded split-mouth pilot study.

    Science.gov (United States)

    Preissner, Saskia; Kastner, Isabell; Schütte, Eyke; Hartwig, Stefan; Schmidt-Westhausen, Andrea Maria; Paris, Sebastian; Preissner, Robert; Hertel, Moritz

    2016-07-01

    Extended use of antimycotics in oral candidiasis therapy gives rise to problems related to fungal drug resistance. The aim of this pilot study was to investigate the efficacy of tissue tolerable plasma (TTP) in denture stomatitis patients. It was hypothesised that (I): erythema and (IIa): complaint remission would be accelerated and (IIb): colony forming unit (CFU) reduction would be improved. The halves of the upper jaws of eight patients were randomly assigned to control (nystatin, chlorhexidine and placebo treatment) and test sides (nystatin, chlorhexidine and TTP administered six times each 7 days). The patients and the investigators, who were different from the therapists, were both blinded. Compared to the control sides, the erythema surface was reduced significantly more extensively on the test sides between 2 and 6 weeks of antifungal therapy (P ≤ 0.05). Visual analogue scale values and the frequency of moderate or heavy growth of Candida post-treatment did not differ significantly between both sides (P > 0.05). The primary hypothesis was confirmed, which may be interpreted as an accelerated remission. As drug therapy is usually limited to the time in which signs of infection are present, TTP might help reducing antifungal use. Even though the secondary hypotheses were not confirmed, persistence of Candida might be only colonisation. © 2016 Blackwell Verlag GmbH.

  9. Effect of Lepidium meyenii Walp. on Semen Parameters and Serum Hormone Levels in Healthy Adult Men: A Double-Blind, Randomized, Placebo-Controlled Pilot Study.

    Science.gov (United States)

    Melnikovova, Ingrid; Fait, Tomas; Kolarova, Michaela; Fernandez, Eloy C; Milella, Luigi

    2015-01-01

    Background/Aims. Products of Lepidium meyenii Walp. (maca) are touted worldwide as an alimentary supplement to enhance fertility and restore hormonal balance. Enhancing properties of maca on semen parameters in animals were previously reported by various authors, but we present to the best of our knowledge the first double-blind, randomized, placebo-controlled pilot trial in men. The aim of this study was to evaluate the effects of maca on semen parameters and serum hormone levels in healthy adult men. Methods. A group of 20 volunteers aged 20-40 years was supplied by milled hypocotyl of maca or placebo (1.75 g/day) for 12 weeks. Negative controls of semen were compared to the samples after 6 and 12 weeks of maca administration; negative blood controls were compared to the samples after 12 weeks of treatment. Results. Sperm concentration and motility showed rising trends compared to placebo even though levels of hormones did not change significantly after 12 weeks of trial. Conclusion. Our results indicate that maca possesses fertility enhancing properties in men. As long as men prefer to use alimentary supplement to enhance fertility rather than prescribed medication or any medical intervention, it is worth continuing to assess its possible benefits.

  10. Effect of Lepidium meyenii Walp. on Semen Parameters and Serum Hormone Levels in Healthy Adult Men: A Double-Blind, Randomized, Placebo-Controlled Pilot Study

    Science.gov (United States)

    Melnikovova, Ingrid; Fait, Tomas; Kolarova, Michaela; Fernandez, Eloy C.

    2015-01-01

    Background/Aims. Products of Lepidium meyenii Walp. (maca) are touted worldwide as an alimentary supplement to enhance fertility and restore hormonal balance. Enhancing properties of maca on semen parameters in animals were previously reported by various authors, but we present to the best of our knowledge the first double-blind, randomized, placebo-controlled pilot trial in men. The aim of this study was to evaluate the effects of maca on semen parameters and serum hormone levels in healthy adult men. Methods. A group of 20 volunteers aged 20–40 years was supplied by milled hypocotyl of maca or placebo (1.75 g/day) for 12 weeks. Negative controls of semen were compared to the samples after 6 and 12 weeks of maca administration; negative blood controls were compared to the samples after 12 weeks of treatment. Results. Sperm concentration and motility showed rising trends compared to placebo even though levels of hormones did not change significantly after 12 weeks of trial. Conclusion. Our results indicate that maca possesses fertility enhancing properties in men. As long as men prefer to use alimentary supplement to enhance fertility rather than prescribed medication or any medical intervention, it is worth continuing to assess its possible benefits. PMID:26421049

  11. Effect of Lepidium meyenii Walp. on Semen Parameters and Serum Hormone Levels in Healthy Adult Men: A Double-Blind, Randomized, Placebo-Controlled Pilot Study

    Directory of Open Access Journals (Sweden)

    Ingrid Melnikovova

    2015-01-01

    Full Text Available Background/Aims. Products of Lepidium meyenii Walp. (maca are touted worldwide as an alimentary supplement to enhance fertility and restore hormonal balance. Enhancing properties of maca on semen parameters in animals were previously reported by various authors, but we present to the best of our knowledge the first double-blind, randomized, placebo-controlled pilot trial in men. The aim of this study was to evaluate the effects of maca on semen parameters and serum hormone levels in healthy adult men. Methods. A group of 20 volunteers aged 20–40 years was supplied by milled hypocotyl of maca or placebo (1.75 g/day for 12 weeks. Negative controls of semen were compared to the samples after 6 and 12 weeks of maca administration; negative blood controls were compared to the samples after 12 weeks of treatment. Results. Sperm concentration and motility showed rising trends compared to placebo even though levels of hormones did not change significantly after 12 weeks of trial. Conclusion. Our results indicate that maca possesses fertility enhancing properties in men. As long as men prefer to use alimentary supplement to enhance fertility rather than prescribed medication or any medical intervention, it is worth continuing to assess its possible benefits.

  12. A Blind Pilot: Who is a Super-Luminal Observer?

    Directory of Open Access Journals (Sweden)

    Rabounski D.

    2008-04-01

    Full Text Available This paper discusses the nature of a hypothetical super-luminal observer who, as well as a real (sub-light speed observer, perceives the world by light waves. This consideration is due to that fact that the theory of relativity permits different frames of reference, including light-like and super-luminal reference frames. In analogy with a blind pilot on board a supersonic jet aeroplane (or missile, perceived by blind people, it is concluded that the light barrier is observed in the framework of only the light signal exchange experiment.

  13. A double-blind, placebo-controlled, parallel-group pilot study of milnacipran for chronic radicular pain (sciatica) associated with lumbosacral disc disease.

    Science.gov (United States)

    Marks, David M; Pae, Chi-Un; Patkar, Ashwin A

    2014-01-01

    The current study investigates whether milnacipran, an equipotent serotonin-norepinephrine reuptake inhibitor, is effective in reducing chronic radicular pain in patients (N = 11) with lumbosacral disc disease. This study is a 10-week randomized, parallel-group, double-blind, placebo-controlled trial of milnacipran (100-200 mg/d, dosed twice a day). Subjects (enrolled from October 2010 to September 2011 through the Duke University Pain and Palliative Care Clinic, Durham, North Carolina) included patients with radiologically confirmed disc disease with nerve root compression. The primary outcome measure was radicular pain measured by visual analog scale score (VAS-Rad); patients were asked to specifically rate radicular pain ("shooting or electrical or prickly pain in 1 or both legs"). Secondary outcome measures included nociceptive low back pain by visual analog scale (VAS-Noc), Oswestry Low Back Pain Disability Questionnaire, Neuropathic Pain Questionnaire, Medical Outcomes Study (MOS) 36-Item Short-Form Health Survey, Beck Depression Inventory, and State-Trait Anxiety Inventory. Between-group changes in outcome measures between baseline and endpoint were analyzed using Mann-Whitney U nonparametric measure of central tendency. Milnacipran treatment yielded statistically significant reduction in radicular pain (VAS-Rad, P = .01) and nociceptive low back pain (VAS-Noc, P = .04) compared to placebo. No statistically significant between-group differences were observed in the other secondary outcome measures. In this small pilot study, milnacipran treatment was associated with reduction in radicular and nociceptive low back pain in patients with lumbosacral disc disease. Larger studies of milnacipran in this population are warranted. ClinicalTrials.gov identifier: NCT01777581.

  14. Hypocaloric diet supplemented with probiotic cheese improves body mass index and blood pressure indices of obese hypertensive patients - a randomized double-blind placebo-controlled pilot study

    Science.gov (United States)

    2013-01-01

    Background Gut lactobacilli can affect the metabolic functions of healthy humans. We tested whether a 1500 kcal/d diet supplemented with cheese containing the probiotic Lactobacillus plantarum TENSIA (Deutsche Sammlung für Mikroorganismen, DSM 21380) could reduce some symptoms of metabolic syndrome in Russian adults with obesity and hypertension. Methods In this 3-week, randomized, double-blind, placebo-controlled, parallel pilot study, 25 subjects ingested probiotic cheese and 15 ingested control cheese. Fifty grams of each cheese provided 175 kcal of energy. Blood pressure (BP), anthropometric characteristics, markers of liver and kidney function, metabolic indices (plasma glucose, lipids, and cholesterol), and urine polyamines were measured. Counts of fecal lactobacilli and L. plantarum TENSIA were evaluated using molecular methods. The data were analyzed by t-test for independent samples and Spearman’s partial correlation analysis. Results The probiotic L. plantarum TENSIA was present in variable amounts (529.6 ± 232.5 gene copies) in 16/25 (64%) study subjects. Body mass index (BMI) was significantly reduced (p = 0.031) in the probiotic cheese group versus the control cheese group. The changes in BMI were closely associated with the water content of the body (r = 0.570, p = 0.0007) when adjusted for sex and age. Higher values of intestinal lactobacilli after probiotic cheese consumption were associated with higher BMI (r = 0.383, p = 0.0305) and urinary putrescine content (r = 0.475, p = 0.006). In patients simultaneously treated with BP-lowering drugs, similar reductions of BP were observed in both groups. A positive association was detected between TENSIA colonization and the extent of change of morning diastolic BP (r = 0.617, p = 0.0248) and a trend toward lower values of morning systolic BP (r = −0.527, p = 0.0640) at the end of the study after adjusting for BMI, age, and sex. Conclusion In a pilot study of obese hypertensive patients, a hypocaloric

  15. An Open-Label Evaluator Blinded Study of the Efficacy and Safety of a New Nutritional Supplement in Androgenetic Alopecia: A Pilot Study

    OpenAIRE

    Nichols, Anna J.; Hughes, Olivia Bosshardt; Canazza, Agnese; Zaiac, Martin N.

    2017-01-01

    Objective: To evaluate the effectiveness of a novel oral supplement, Forti5?, containing green tea extract, omega 3 and 6 fatty acids, cholecalciferol, melatonin, beta-sitosterol, and soy isoflavones, and in the management of subjects with androgenetic alopecia. Design: A prospective case series of 10 subjects. Setting: Open-label, evaluator-blinded, proof-of-concept study. Participants: Ten adult subjects with androgenetic alopecia completed the study. Subjects were not allowed to use oral o...

  16. Intermittent treatment with mesalazine in the prevention of diverticulitis recurrence: a randomised multicentre pilot double-blind placebo-controlled study of 24-month duration.

    Science.gov (United States)

    Parente, F; Bargiggia, S; Prada, A; Bortoli, A; Giacosa, A; Germanà, B; Ferrari, A; Casella, G; De Pretis, G; Miori, G

    2013-10-01

    Recurrence of diverticulitis is frequent within 5 years from the uncomplicated first attack, and its prophylaxis is still unclear. We have undertaken a multicentre, randomised, double-blind, placebo-controlled pilot study in order to evaluate the role of mesalazine in preventing diverticulitis recurrence as well as its effects on symptoms associated to diverticular disease. Ninety-six patients with the recent first episode of uncomplicated diverticulitis were randomised to receive mesalazine 800 mg twice daily for 10 days every month or placebo for 24 months. The primary efficacy end point was the diverticulitis recurrence at intention to treat analysis. Clinical evaluations were performed using the Therapy Impact Questionnaire (TIQ) for physical condition and quality of life at admission and at 3-month intervals. Treatment tolerability and routine biochemistry parameters as well as the use of additional drugs were also evaluated. Ninety-two patients (mean age, 61.5) completed the study, 45 of whom received mesalazine, and 47, placebo. Diverticulitis relapse incidence in mesalazine-treated group was 5/45 (11%) at the 12th month and 6/45 (13%) at the 24th month; in the placebo-treated group, the correspondent rates were 13% (6/47) and 28% (13/47), respectively. Mean values of TIQ at 24 months were significantly better in mesalazine-treated group than in placebo-treated group (p = 0.02); in addition, average additional drug consumption was significantly lower (-20.4%, p Diverticulitis recurrence occurred in as many as 28% of patients under placebo within 24 months from the initial episode. Intermittent prophylaxis with mesalazine did not significantly reduce the risk of relapse but induced a significant improvement of patients' physical conditions and significantly lowered the additional consumption of other gastrointestinal drugs.

  17. A pilot double-blind randomised placebo-controlled dose-response trial assessing the effects of melatonin on infertility treatment (MIART): study protocol.

    Science.gov (United States)

    Fernando, Shavi; Osianlis, Tiki; Vollenhoven, Beverley; Wallace, Euan; Rombauts, Luk

    2014-09-01

    High levels of oxidative stress can have considerable impact on the outcomes of in vitro fertilisation (IVF). Recent studies have reported that melatonin, a neurohormone secreted from the pineal gland in response to darkness, has significant antioxidative capabilities which may protect against the oxidative stress of infertility treatment on gametes and embryos. Early studies of oral melatonin (3-4 mg/day) in IVF have suggested favourable outcomes. However, most trials were poorly designed and none have addressed the optimum dose of melatonin. We present a proposal for a pilot double-blind randomised placebo-controlled dose-response trial aimed to determine whether oral melatonin supplementation during ovarian stimulation can improve the outcomes of assisted reproductive technology. We will recruit 160 infertile women into one of four groups: placebo (n=40); melatonin 2 mg twice per day (n=40); melatonin 4 mg twice per day (n=40) and melatonin 8 mg twice per day (n=40). The primary outcome will be clinical pregnancy rate. Secondary clinical outcomes include oocyte number/quality, embryo number/quality and fertilisation rate. We will also measure serum melatonin and the oxidative stress marker, 8-hydroxy-2'-deoxyguanosine at baseline and after treatment and levels of these in follicular fluid at egg pick-up. We will investigate follicular blood flow with Doppler ultrasound, patient sleepiness scores and pregnancy complications, comparing outcomes between groups. This protocol has been designed in accordance with the SPIRIT 2013 Guidelines. Ethical approval has been obtained from Monash Health HREC (Ref: 13402B), Monash University HREC (Ref: CF14/523-2014000181) and Monash Surgical Private Hospital HREC (Ref: 14107). Data analysis, interpretation and conclusions will be presented at national and international conferences and published in peer-reviewed journals. ACTRN12613001317785. Published by the BMJ Publishing Group Limited. For permission to use (where

  18. Safety and physiological effects of two different doses of elosulfase alfa in patients with morquio a syndrome: A randomized, double‐blind, pilot study

    Science.gov (United States)

    Burton, Barbara K.; Berger, Kenneth I.; Lewis, Gregory D.; Tarnopolsky, Mark; Treadwell, Marsha; Mitchell, John J.; Muschol, Nicole; Jones, Simon A.; Sutton, V. Reid; Pastores, Gregory M.; Lau, Heather; Sparkes, Rebecca; Genter, Fred; Shaywitz, Adam J.

    2015-01-01

    The primary treatment outcomes of a phase 2, randomized, double‐blind, pilot study evaluating safety, physiological, and pharmacological effects of elosulfase alfa in patients with Morquio A syndrome are herewith presented. Patients aged ≥7 years and able to walk ≥200 m in the 6‐min walk test (6MWT) were randomized to elosulfase alfa 2.0 or 4.0 mg/kg/week for 27 weeks. The primary objective was to evaluate the safety of both doses. Secondary objectives were to evaluate effects on endurance (6MWT and 3‐min stair climb test [3MSCT]), exercise capacity (cardio‐pulmonary exercise test [CPET]), respiratory function, muscle strength, cardiac function, pain, and urine keratan sulfate (uKS) levels, and to determine pharmacokinetic parameters. Twenty‐five patients were enrolled (15 randomized to 2.0 mg/kg/week and 10 to 4.0 mg/kg/week). No new or unexpected safety signals were observed. After 24 weeks, there were no improvements versus baseline in the 6MWT, yet numerical improvements were seen in the 3MSCT with 4.0 mg/kg/week. uKS and pharmacokinetic data suggested no linear relationship over the 2.0–4.0 mg/kg dose range. Overall, an abnormal exercise capacity (evaluated in 10 and 5 patients in the 2.0 and 4.0 mg/kg/week groups, respectively), impaired muscle strength, and considerable pain were observed at baseline, and there were trends towards improvements in all domains after treatment. In conclusion, preliminary data of this small study in a Morquio A population with relatively good endurance confirmed the acceptable safety profile of elosulfase alfa and showed a trend of increased exercise capacity and muscle strength and decreased pain. © 2015 The Authors. American Journal of Medical Genetics Part A Published by Wiley Periodicals, Inc. PMID:26069231

  19. Enteral L-arginine supplementation for prevention of necrotizing enterocolitis in very low birth weight neonates: a double-blind randomized pilot study of efficacy and safety.

    Science.gov (United States)

    Polycarpou, Elena; Zachaki, Sophia; Tsolia, Maria; Papaevangelou, Vasiliki; Polycarpou, Nicodemos; Briana, Despina D; Gavrili, Stavroula; Kostalos, Christos; Kafetzis, Dimitrios

    2013-09-01

    Necrotizing enterocolitis (NEC) is the most common acquired gastrointestinal disease in premature infants and has high mortality and morbidity. Endothelial nitric oxide is an important regulator of vascular perfusion and is synthetized from the amino acid L-arginine. Hypoargininemia is frequently observed in preterm neonates and may predispose them to NEC. Our objective was to determine the effect of enteral L-arginine supplementation on the incidence and severity of NEC in very low birth weight (VLBW) neonates. We conducted a parallel blind randomized pilot study, comprising VLBW neonates with birth weight ≤1500 g and gestational age ≤34 weeks. VLBW neonates were randomly assigned to receive enteral L-arginine supplementation (1.5 mmol/kg/d bid) between the 3rd and 28th day of life or placebo. Diagnosis and classification of NEC were done according to modified Bell's criteria. Eighty-three neonates were randomized to the arginine (n = 40) or placebo (n = 43) group. No adverse effects were observed in neonates receiving L-arginine supplementation. The incidence of NEC stage III was significantly lower in the arginine-supplemented group (2.5% vs 18.6%, P = .030). Enteral L-arginine supplementation of 1.5 mmol/kg/d bid can be safely administered in VLBW neonates from the 3rd to the 28th day of life. Enteral L-arginine supplementation appears to reduce the incidence of stage III NEC in VLBW infants. Larger studies are needed to further evaluate the effect of L-arginine supplementation in preventing NEC in VLBW infants.

  20. Head-and-Neck Target Delineation Among Radiation Oncology Residents After a Teaching Intervention: A Prospective, Blinded Pilot Study

    International Nuclear Information System (INIS)

    Bekelman, Justin E.; Wolden, Suzanne; Lee, Nancy

    2009-01-01

    Purpose: We conducted this study to determine the feasibility of incorporating a teaching intervention on target delineation into the educational curriculum of a radiation oncology residency program and to assess the short-term effects on resident skills. Methods and Materials: The study schema consisted of a baseline evaluation, the teaching intervention, and a follow-up evaluation. At the baseline evaluation, the participants contoured three clinical tumor volumes (CTVs) (70 Gy, 59.4 Gy, and 54 Gy) on six contrast-enhanced axial computed tomography images of a de-identified patient with Stage T2N2bM0 squamous cell carcinoma of the right base of the tongue. The participants attended a series of head-and-neck oncology and anatomy seminars. The teaching intervention consisted of a didactic lecture and an interactive hands-on practical session designed to improve the knowledge and skills for target delineation in the head and neck. At the follow-up evaluation, the residents again contoured the CTVs. Results: Of the 14 eligible residents, 11 (79%) actually participated in the study. For all participants, but especially for those who had not had previous experience with head-and-neck target delineation, the teaching intervention was associated with improvement in the delineation of the node-negative neck (CTV 54 Gy contour). Regardless of clinical experience, participants had difficulty determining what should be included in the CTV 59.4 Gy contour to ensure adequate coverage of potential microscopic disease. Conclusion: Incorporating a teaching intervention into the education curriculum of a radiation oncology residency program is feasible and was associated with short-term improvements in target delineation skills. Subsequent interventions will require content refinement, additional validation, longer term follow-up, and multi-institutional collaboration

  1. A Randomized, Double-Blind Pilot Study of Dose Comparison of Ramosetron to Prevent Chemotherapy-Induced Nausea and Vomiting

    Directory of Open Access Journals (Sweden)

    Ka-Rham Kim

    2015-01-01

    Full Text Available Purpose. This study was conducted to determine the optimal dose titration of ramosetron to prevent the Rhodes Index of Nausea, Vomiting, and Retching (RINVR. Methods. Patients treated with folic acid, 5-fluorouracil, and oxaliplatin were randomized into three groups (0.3 mg, 0.45 mg, and 0.6 mg ramosetron before chemotherapy. The pharmacokinetics and pharmacodynamics using RINVR were evaluated. Results. Seventeen, 15, and 18 patients received ramosetron at doses of 0.3 mg, 0.45 mg, and 0.6 mg, respectively. Tmax (h, Cmax (ng/mL, and AUClast (ng·h/mL were associated with dose escalation significantly, showing a reverse correlation with the RINVR during chemotherapy. Acute CINV was observed in four patients (22.2%, two patients (14.3%, and one (5.6% patient and a delayed CINV on day 7 was found in eight (47%, three (21.4%, and five (27.8% patients in each group. The complete response rate was increased with dose escalation (35.3%, 50.0%, and 72.2% in each group and also showed the tendency for decreasing moderate-to-severe CINV. Conclusions. This study shows a trend regarding the dose-response relationship for ramosetron to prevent CINV, including delayed emesis. It suggested that dose escalation should be considered in patients with CINV in a subsequent cycle of chemotherapy, and an individual approach using RINVR could be useful to monitor CINV.

  2. Acute effects of exergames on cognitive function of institutionalized older persons: a single-blinded, randomized and controlled pilot study.

    Science.gov (United States)

    Monteiro-Junior, Renato Sobral; da Silva Figueiredo, Luiz Felipe; Maciel-Pinheiro, Paulo de Tarso; Abud, Erick Lohan Rodrigues; Braga, Ana Elisa Mendes Montalvão; Barca, Maria Lage; Engedal, Knut; Nascimento, Osvaldo José M; Deslandes, Andrea Camaz; Laks, Jerson

    2017-06-01

    Improvements on balance, gait and cognition are some of the benefits of exergames. Few studies have investigated the cognitive effects of exergames in institutionalized older persons. To assess the acute effect of a single session of exergames on cognition of institutionalized older persons. Nineteen institutionalized older persons were randomly allocated to Wii (WG, n = 10, 86 ± 7 year, two males) or control groups (CG, n = 9, 86 ± 5 year, one male). The WG performed six exercises with virtual reality, whereas CG performed six exercises without virtual reality. Verbal fluency test (VFT), digit span forward and digit span backward were used to evaluate semantic memory/executive function, short-term memory and work memory, respectively, before and after exergames and Δ post- to pre-session (absolute) and Δ % (relative) were calculated. Parametric (t independent test) and nonparametric (Mann-Whitney test) statistics and effect size were applied to tests for efficacy. VFT was statistically significant within WG (-3.07, df = 9, p = 0.013). We found no statistically significant differences between the two groups (p > 0.05). Effect size between groups of Δ % (median = 21 %) showed moderate effect for WG (0.63). Our data show moderate improvement of semantic memory/executive function due to exergames session. It is possible that cognitive brain areas are activated during exergames, increasing clinical response. A single session of exergames showed no significant improvement in short-term memory, working memory and semantic memory/executive function. The effect size for verbal fluency was promising, and future studies on this issue should be developed. RBR-6rytw2.

  3. Effect of Hominis placenta Pharmacopuncture on the Dysmenorrhea (A Pilot study, Single blind, Randomized, Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Su-Min Kim

    2008-09-01

    Full Text Available Objective : This study was designed to evaluate the effect of Hominis placenta Pharmacopuncture treatment on Dysmenorrhea of Women. Methods : 49 subjects who were suffering from dysmenorrhea volunteered to answer the MMP(Measure of Menstrual Pain and MSSL(Menstrual Symptom Severity List questionnaire. They were divided into two groups, a Hominis placenta Pharmacopuncture treatment group(Experiment al group, n=25 and a Normal Saline(N/S treatment group(Control group, n=24. The two groups were injected on the CV4, S36, Sp9 and Sp6 acupuncture point. They were treated totally five times depending on the individual menstruation cycles. The scores of MMP and MSSL were measured overall three times before and after the menstruation cycle. The collected data were analyzed as paired t-test, independent t-test using SPSS 12.0 WIN Program. Results : As a result of the evaluation by MMP and MSSL, a significant improvement on dysmenorrhea was made in the two groups(p<0.05, and both scores of Experiment group were decreased more than Control group. But there was no significant difference between the two groups. Conclusions : The Hominis placenta Pharmacopuncture treatment and the Normal Saline treatment were effective in decreasing the symptom of Dysmenorrhea.

  4. A pilot study on efficacy treatment of acne vulgaris using a new method: results of a randomized double-blind trial with Acne Dressing.

    Science.gov (United States)

    Chao, Chao-Ming; Lai, Wei-Yu; Wu, Bai-Yao; Chang, Hung-Chia; Huang, Wei-Shuan; Chen, Yu-Fei

    2006-01-01

    For many years the positive effect of hydrocolloid dressings on skin-related conditions attracted the attention of the medical scientific community. The use of Acne Dressing, a tape of hydrocolloid dressing, for the treatment of acne has not been reported previously. The aim of this study was to evaluate the clinical efficacy and beneficial effect of Acne Dressing on the marker for sebum output evaluations. We also determined the cosmetic outcome of this application during the treatment of acne and whether the material could prevent hand touching and UVB light from reaching the skin surface. The objective of this study was to assess improvement in acne vulgaris and tolerability during one week of short contact treatment with Acne Dressing compared to skin tapes. Efficacy data specific to treatment of acne vulgaris with Acne Dressing (3M Health Care) from a double-blind, randomized, skin types-controlled study is reported. A total of 20 patients with mild-to-moderate acne vulgaris applied the skin tapes or Acne Dressing every two days for up to one week. Twenty patients were enrolled in this study: ten patients received Acne Dressing and ten patients received skin tapes. Both groups showed decreases from baseline to the end of treatment in the mean of the overall severity scale (decrease of 1.37 from 1.8 to 0.43 with Acne Dressing and 0.28 from 1.08 to 0.8 with skin tapes). A statistically significant greater reduction was observed over a period of three to seven days in the overall severity of acne and inflammation in the Acne Dressing group compared with the mono-therapy (skin tapes) group. Similarly, Acne Dressing resulted in a significantly greater improvement in the redness, oiliness, dark pigmentation, and sebum casual level at days 3, 5, and 7. The ratio of transmission of UVB light with Acne Dressing was 7.4%, and 38% with skin tapes, which shows less UVB light reaching the skin surface with the Acne Dressing. No significant adverse events were identified in

  5. Ranolazine versus placebo in patients with ischemic cardiomyopathy and persistent chest pain or dyspnea despite optimal medical and revascularization therapy: randomized, double-blind crossover pilot study

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    Shammas NW

    2015-03-01

    Full Text Available Nicolas W Shammas,1 Gail A Shammas,1 Kathleen Keyes,2 Shawna Duske,1 Ryan Kelly,1 Michael Jerin3 1Midwest Cardiovascular Research Foundation, 2Cardiovascular Medicine, Private Corporation, 3St Ambrose University, Davenport, IA, USA Background: Patients with ischemic cardiomyopathy (ICM may continue to experience persistent chest pain and/or dyspnea despite pharmacologic therapy and revascularization. We hypothesized that ranolazine would reduce anginal symptoms or dyspnea in optimally treated ICM patients.Methods: In this randomized, double-blind, crossover-design pilot study, 28 patients with ICM (ejection fraction less or equal 40% were included after providing informed consent. A total of 24 patients completed both placebo and ranolazine treatments and were analyzed. All patients were on treatment with a beta blocker, an angiotensin-converting enzyme inhibitor (or angiotensin receptor blocker, and at least one additional antianginal drug. After randomization, patients received up to 1,000 mg ranolazine orally twice a day, as tolerated, versus placebo. The primary end point was change in angina as assessed by the Seattle Angina Questionnaire (SAQ, or in dyspnea as assessed by the Rose Dyspnea Scale (RDS. Change in the RDS and SAQ score from baseline was compared, for ranolazine and placebo, using the Wilcoxon signed rank test or paired t-test.Results: Patients had the following demographic and clinical variables: mean age of 71.5 years; male (82.1%; prior coronary bypass surgery (67.9%; prior coronary percutaneous intervention (85.7%; prior myocardial infarction (82.1%; diabetes (67.9%; and mean ejection fraction of 33.1%. No statistical difference was seen between baseline RDS score and that after placebo or ranolazine (n=20 (P≥0.05. There was however, an improvement in anginal frequency (8/10 patients (P=0.058, quality of life (8/10 patients (P=0.048, and mean score of all components of the SAQ questionnaire (n=10 (P=0.047 with ranolazine

  6. A randomized, double blind, placebo and active comparator controlled pilot study of UP446, a novel dual pathway inhibitor anti-inflammatory agent of botanical origin

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    Sampalis John S

    2012-04-01

    Full Text Available Abstract Background Current use of prescribed or over the counter non-steroidal anti-inflammatory drugs (NSAIDs for pain and osteoarthritis (OA have untoward gastrointestinal and cardiovascular related side effects, as a result the need for a safe and effective alternative has become unequivocally crucial. Method A randomized, double blind, placebo and active controlled pilot study of a novel dual pathway, COX1/2 and LOX, inhibitor anti-inflammatory agent of botanical origin, UP446 was conducted. Sixty subjects (age 40-75 with symptomatic OA of the hip or knee were assigned to 4 treatment groups (n = 15; Group A0 (Placebo, CMC capsule, Group A1 (UP446 250 mg/day, Group A2 (UP446 500 mg/day and Group A3 (Celecoxib, 200 mg/day. MOS-SF-36 and Western Ontario and McMaster University Osteoarthritis Index (WOMAC data were collected at baseline and after 30, 60 and 90 days of treatment as a measure of efficacy. Erythrocyte sedimentation rate, C-reactive protein, plasma thrombin time (PTT, fructosamine, Hematology, clinical chemistry and fecal occult blood were monitored for safety. Results Statistically significant decrease in WOMAC pain score were observed for Group A1 at day 90, Group A2 at 30 and 90 days and Group A3 at 60 and 90 days. Statistically significant decrease in WOMAC stiffness score were observed for Group A1 and Group A2 at 30, 60 and 90 days; but not for Group A0 and Group A3. The mean change in WOMAC functional impairment scores were statistically significant for Group A1 and Group A2 respectively at 30 days (p = 0.006 and p = 0.006, at 60 days (p = 0.016 and p = 0.002 and at 90 days (p = 0.018 and p = 0.002, these changes were not significant for Group A0 and Group A3. Based on MOS -SF-36 questionnaires, statistically significant improvements in physical function, endurance and mental health scores were observed for all active treatment groups compared to placebo. No significant changes suggestive of toxicity in routine hematologies

  7. The effect of mirtazapine in panic disorder : an open label pilot study with a single-blind placebo run-in period

    NARCIS (Netherlands)

    Boshuisen, ML; Slaap, BR; Vester-Blokland, ED; den Boer, JA

    2001-01-01

    In this open label pilot study, we studied the efficacy of mirtazapine (Remeron) in panic disorder. Twenty-eight patients with a DSM-IV diagnosis of panic disorder, with or without agoraphobia (10 males/18 females), were included and 19 patients completed the study. The 15-week trial started with a

  8. Olanzapine plus dialectical behavior therapy for women with high irritability who meet criteria for borderline personality disorder: a double-blind, placebo-controlled pilot study.

    Science.gov (United States)

    Linehan, Marsha M; McDavid, Joshua D; Brown, Milton Z; Sayrs, Jennifer H R; Gallop, Robert J

    2008-06-01

    This double-blind study examined whether olanzapine augments the efficacy of dialectical behavior therapy (DBT) in reducing anger and hostility in borderline personality disorder patients. Twenty-four women with borderline personality disorder (DSM-IV criteria) and high levels of irritability and anger received 6 months of DBT. Subjects were randomly assigned to receive either low-dose olanzapine or placebo and were assessed with standardized measures in a double-blind manner. The study was conducted from September 2000 to December 2002. Intent-to-treat analyses indicated that both treatment conditions resulted in significant improvement in irritability, aggression, depression, and self-inflicted injury (p borderline personality disorder. Effect sizes were moderate to large, with the small sample size likely limiting the ability to detect significant results. Overall, there were large and consistent reductions in irritability, aggression, depression, and self-injury for both groups of subjects receiving DBT.

  9. An Open-Label Evaluator Blinded Study of the Efficacy and Safety of a New Nutritional Supplement in Androgenetic Alopecia: A Pilot Study.

    Science.gov (United States)

    Nichols, Anna J; Hughes, Olivia Bosshardt; Canazza, Agnese; Zaiac, Martin N

    2017-02-01

    Objective: To evaluate the effectiveness of a novel oral supplement, Forti5 ® , containing green tea extract, omega 3 and 6 fatty acids, cholecalciferol, melatonin, beta-sitosterol, and soy isoflavones, and in the management of subjects with androgenetic alopecia. Design: A prospective case series of 10 subjects. Setting: Open-label, evaluator-blinded, proof-of-concept study. Participants: Ten adult subjects with androgenetic alopecia completed the study. Subjects were not allowed to use oral or topical hair growth products in the 24 weeks preceding the study or during the study. The nutritional supplement was administered at a dosage of two tablets daily for 24 weeks. Measurements: Clinical evaluations were performed at baseline and at 24 weeks. Efficacy was evaluated using hair mass index measured by cross section trichometer, terminal hair count measured with dermoscopy and Investigator Global Photography Assessment. Results: Overall 80 percent of subjects (8/10) were rated as improved after 24 weeks of supplementation (mean change of +1.4 equivalent to slightly-to-moderately increased). Forty percent of subjects (4/10) were rated as moderately improved (2+), and 10 percent (1/10) were rated as greatly improved (3+). There was a significant improvement in terminal hair count (mean increase of 5.9% or 4.2 more terminal hairs in the area examined, p =0.014) and in Hair Mass Index (mean increase of 9.5% or 4.5 higher Hair Mass Index, p =0.003). Conclusion: These preliminary results indicate that Forti5 ® a novel nutritional supplement that contains cholecalciferol, omega 3 and 6 fatty acids, melatonin, antioxidants, and botanical 5-alpha reductase inhibitors, may be a useful adjunct in the treatment of androgenetic alopecia.

  10. A Novel Hands-Free Abdominal Compression Device for Colonoscopy Significantly Decreases Cecal Intubation Time: A Prospective Single-Blinded Pilot Study.

    Science.gov (United States)

    Schulman, Allison R; Ryou, Marvin; Chan, Walter W

    2017-06-01

    Colonoscopy outcome is limited by endoscope looping, which leads to patient discomfort, prolonged procedure, and increased sedation requirement. Traditional manual abdominal pressure is imprecise and manually intensive. A hands-free abdominal compression device (ACD) may improve colonoscopy outcome. We aimed to assess the effect of a novel ACD on colonoscopy outcomes compared to manual pressure. This was a prospective single-blinded study of patients undergoing outpatient colonoscopy. The ACD (N-Doe Pillow™) was applied on 50 consecutive patients. Endoscopists were blinded to device usage. Control cases using manual pressure were randomly selected in a 2:1 manner. Primary outcome was cecal intubation time. Secondary outcomes included sedation requirement and complications. Subgroup analyses evaluated ACD effect on endoscopists with different experiences and patients at higher risk of difficult colonoscopy. Fisher's exact and Student's t-tests were performed for univariate analyses. Multivariate analysis was performed using generalized linear regression. Fifty patients undergoing colonoscopy with ACD assistance were compared to 100 matched controls. Mean cecal intubation time was significantly reduced in the ACD group compared to controls (6.38 minutes versus 11.8 minutes, P ACD use was independently associated with reduction in cecal intubation time (β-coeff: -4.11, P = .007). Subgroup analyses revealed a trend toward increased improvement in cecal intubation time among junior endoscopists and obese patients. A novel, hands-free ACD significantly decreased cecal intubation time in this prospective, single-blinded, match-controlled study. A trend toward more improvement was seen among junior faculty, suggesting an application for trainees and/or endoscopists with smaller case volumes.

  11. Asperger syndrome and anxiety disorders (PAsSA) treatment trial: a study protocol of a pilot, multicentre, single-blind, randomised crossover trial of group cognitive behavioural therapy

    Science.gov (United States)

    Langdon, Peter E; Murphy, Glynis H; Wilson, Edward; Shepstone, Lee; Fowler, David; Heavens, David; Malovic, Aida; Russell, Alexandra

    2013-01-01

    Introduction A number of studies have established that children, adolescents and adults with Asperger syndrome (AS) and high functioning autism (HFA) have significant problems with anxiety. Cognitive behavioural therapy (CBT) is an effective treatment for anxiety in a variety of clinical populations. There is a growing interest in exploring the effectiveness of CBT for people with AS who have mental health problems, but currently there are no known clinical trials involving adults with AS or HFA. Studies with children who have AS have reported some success. The current study aims to examine whether modified group CBT for clinically significant anxiety in an AS population is likely to be efficacious. Methods and analysis This study is a randomised, single-blind crossover trial. At least 36 individuals will be recruited and randomised into a treatment arm or a waiting-list control arm. During treatment, individuals will receive 3 sessions of individual CBT, followed by 21 sessions of group CBT. Primary outcome measures focus on anxiety. Secondary outcome measures focus on everyday social and psychiatric functioning, additional measures of anxiety and fear, depression, health-related quality of life and treatment cost. Assessments will be administered at pregroup and postgroup and at follow-up by researchers who are blinded to group allocation. The trial aims to find out whether or not psychological treatments for anxiety can be adapted and used to successfully treat the anxiety experienced by people with AS. Furthermore, we aim to determine whether this intervention represents good value for money. Ethics and dissemination The trial received a favourable ethical opinion from a National Health Service (NHS) Research Ethics Committee. All participants provided written informed consent. Findings will be shared with all trial participants, and the general public, as well as the scientific community. Trial Registration ISRCTN 30265294 (DOI: 10.1186/ISRCTN30265294), UKCRN

  12. Asperger syndrome and anxiety disorders (PAsSA) treatment trial: a study protocol of a pilot, multicentre, single-blind, randomised crossover trial of group cognitive behavioural therapy.

    Science.gov (United States)

    Langdon, Peter E; Murphy, Glynis H; Wilson, Edward; Shepstone, Lee; Fowler, David; Heavens, David; Malovic, Aida; Russell, Alexandra

    2013-07-30

    A number of studies have established that children, adolescents and adults with Asperger syndrome (AS) and high functioning autism (HFA) have significant problems with anxiety. Cognitive behavioural therapy (CBT) is an effective treatment for anxiety in a variety of clinical populations. There is a growing interest in exploring the effectiveness of CBT for people with AS who have mental health problems, but currently there are no known clinical trials involving adults with AS or HFA. Studies with children who have AS have reported some success. The current study aims to examine whether modified group CBT for clinically significant anxiety in an AS population is likely to be efficacious. This study is a randomised, single-blind crossover trial. At least 36 individuals will be recruited and randomised into a treatment arm or a waiting-list control arm. During treatment, individuals will receive 3 sessions of individual CBT, followed by 21 sessions of group CBT. Primary outcome measures focus on anxiety. Secondary outcome measures focus on everyday social and psychiatric functioning, additional measures of anxiety and fear, depression, health-related quality of life and treatment cost. Assessments will be administered at pregroup and postgroup and at follow-up by researchers who are blinded to group allocation. The trial aims to find out whether or not psychological treatments for anxiety can be adapted and used to successfully treat the anxiety experienced by people with AS. Furthermore, we aim to determine whether this intervention represents good value for money. The trial received a favourable ethical opinion from a National Health Service (NHS) Research Ethics Committee. All participants provided written informed consent. Findings will be shared with all trial participants, and the general public, as well as the scientific community. ISRCTN 30265294 (DOI: 10.1186/ISRCTN30265294), UKCRN 8370.

  13. A randomized, double-blind, placebo-controlled pilot study of sublingual versus oral immunotherapy for the treatment of peanut allergy.

    Science.gov (United States)

    Narisety, Satya D; Frischmeyer-Guerrerio, Pamela A; Keet, Corinne A; Gorelik, Mark; Schroeder, John; Hamilton, Robert G; Wood, Robert A

    2015-05-01

    Although promising results have emerged regarding oral immunotherapy (OIT) and sublingual immunotherapy (SLIT) for the treatment of peanut allergy (PA), direct comparisons of these approaches are limited. This study was conducted to compare the safety, efficacy, and mechanistic correlates of peanut OIT and SLIT. In this double-blind study children with PA were randomized to receive active SLIT/placebo OIT or active OIT/placebo SLIT. Doses were escalated to 3.7 mg/d (SLIT) or 2000 mg/d (OIT), and subjects were rechallenged after 6 and 12 months of maintenance. After unblinding, therapy was modified per protocol to offer an additional 6 months of therapy. Subjects who passed challenges at 12 or 18 months were taken off treatment for 4 weeks and rechallenged. Twenty-one subjects aged 7 to 13 years were randomized. Five discontinued therapy during the blinded phase. Of the remaining 16, all had a greater than 10-fold increase in challenge threshold after 12 months. The increased threshold was significantly greater in the active OIT group (141- vs 22-fold, P = .01). Significant within-group changes in skin test results and peanut-specific IgE and IgG4 levels were found, with overall greater effects with OIT. Adverse reactions were generally mild but more common with OIT (P < .001), including moderate reactions and doses requiring medication. Four subjects had sustained unresponsiveness at study completion. OIT appeared far more effective than SLIT for the treatment of PA but was also associated with significantly more adverse reactions and early study withdrawal. Sustained unresponsiveness after 4 weeks of avoidance was seen in only a small minority of subjects. Copyright © 2014 American Academy of Allergy, Asthma & Immunology. All rights reserved.

  14. Impact of Melatonin on Sleep and Pain After Total Knee Arthroplasty Under Regional Anesthesia With Sedation: A Double-Blind, Randomized, Placebo-Controlled Pilot Study.

    Science.gov (United States)

    Kirksey, Meghan A; Yoo, Daniel; Danninger, Thomas; Stundner, Ottokar; Ma, Yan; Memtsoudis, Stavros G

    2015-12-01

    This pilot study explores sleep disruption after total knee arthroplasty and the impact of melatonin on sleep and postoperative pain. Sleep time was decreased on the last preoperative night and first two postoperative nights. Sleep efficiency was decreased on all three postoperative nights. Compared to placebo, melatonin increased sleep efficiency by 4.4% (mean; 95% CI -1.6, 10.4; P=0.150) and sleep time by 29 min (mean; 95% CI -2.0, 60.4; P=0.067). Melatonin appeared to have no effect on subjective sleep quality or daytime sleepiness, pain at rest or pain with standardized activity. In conclusion, sleep quality is impaired after total knee arthroplasty and exogenous melatonin does not appear to improve postoperative sleep or pain to a significant degree. Copyright © 2015 Elsevier Inc. All rights reserved.

  15. The effect of Neydharting mud-pack therapy on knee osteoarthritis: a randomized, controlled, double-blind follow-up pilot study.

    Science.gov (United States)

    Tefner, Ildikó Katalin; Gaál, Ramóna; Koroknai, András; Ráthonyi, Adél; Gáti, Tamás; Monduk, Péter; Kiss, Edit; Kovács, Csaba; Bálint, Géza; Bender, Tamás

    2013-10-01

    The aim of this study was to evaluate the effects of Neydharting mud-pack therapy on the clinical parameters and quality of life in patients with knee osteoarthritis. In this double-blind, randomized, follow-up study on 53 patients with knee osteoarthritis, one group received hot mud-pack therapy, whereas the other (control) group was treated with hot packs of a substance manufactured on 10 occasions for 2 weeks. Western Ontario and McMaster Universities Arthritis Index (WOMAC), EuroQoL-5D quality-of-life measure and need for analgesics and non-steroidal anti-inflammatory drugs were recorded before treatment, at the end of treatment (at Week 2), and at Weeks 6 and 12. The WOMAC and the EQ5D quality-of-life scores improved from the baseline to the end of treatment in both groups, and further improvement was observed during the follow-up period (p pack has a favorable effect on the clinical parameters, quality of life, and need for medications in patients with knee osteoarthritis. To evaluate the chemical effect, the number of patients should be increased.

  16. Psychometric evaluation of a radio electric auricular treatment for stress related disorders: a double-blinded, placebo-controlled controlled pilot study

    Directory of Open Access Journals (Sweden)

    Aravagli Lucia

    2010-03-01

    Full Text Available Abstract Background The aim of this double-blind randomized study is to test the efficacy of a radio electric stimulator device using an auricular reflex therapy protocol for stress-related symptoms. Methods The study has been carried out on 200 subjects (138 females, 62 males that voluntarily came to our Institute declaring to "feel stressed". The participants were randomly allocated with a computerized procedure: 150 were treated with auricular therapeutic protocol with radio electric stimulator device (REAC and 50 were treated with an inactivated, placebo REAC. Psychological stress was evaluated trough the self-administered questionnaire Psychological Stress Measure (PSM. Assessment data were collected at 2 time points: before the treatment (T0 and immediately after the therapy cycle of 18 sessions about 4 weeks later (T1. Results In the group treated with REAC, the psychometric evaluation after the therapy's cycle showed a significant reduction of PSM total scores, from 107.8 ± 23,13 at T0 to 87.1 ± 16,21 at T1 (p Conclusions The protocol of the auricular treatment with REAC seems to reduce the subjective perception of stress, as "psychometrically" demonstrated by the significant reduction in PSM test total score. This therapeutical procedure also provides a non invasive, not painful and very simple innovative approach to treat the widely diffused stress related disorders. Trial Registration This trial has been registered in the Australian New Zealand Clinical Trials Registry (ANZCTR with the number: ACTRN12607000529448

  17. Repetitive transcranial magnetic stimulation for apathy in mild cognitive impairment: A double-blind, randomized, sham-controlled, cross-over pilot study.

    Science.gov (United States)

    Padala, Prasad R; Padala, Kalpana P; Lensing, Shelly Y; Jackson, Andrea N; Hunter, Cassandra R; Parkes, Christopher M; Dennis, Richard A; Bopp, Melinda M; Caceda, Ricardo; Mennemeier, Mark S; Roberson, Paula K; Sullivan, Dennis H

    2018-03-01

    Apathy is a common and disabling behavioral concomitant of many neurodegenerative conditions. The presence of apathy with Mild Cognitive Impairment (MCI) is linked with heightened rates of conversion to Alzheimer's disease. Improving apathy may slow the neurodegenerative process. The objective was to establish the efficacy of repetitive transcranial magnetic stimulation (rTMS) in improving apathy in older adults with MCI. An 8-week, double-blind, randomized, sham-controlled cross-over study was conducted in nine subjects (66 ± 9 years) with apathy and MCI. Subjects were randomized to rTMS or sham treatment (5 days/week) for 2 weeks following which they underwent a 4-week treatment-free period. Subjects then crossed-over to receive the other treatment for 2 weeks. The primary (apathy (AES-C)) and secondary (cognition (3MS & MMSE), executive function (TMT-A & TMT-B), and clinical global impression (CGI)) outcomes were assessed at baseline, 2, 6, and 8 weeks. After adjusting for baseline, there was a significantly greater improvement in the AES-C with rTMS compared to sham treatment at 2 weeks. There was significantly greater improvement in 3MS, MMSE, TMT-A, and CGI-I with rTMS compared to the sham treatment. This study establishes that rTMS is efficacious in improving apathy in subjects with MCI. Published by Elsevier B.V.

  18. Safety, Tolerance, and Enhanced Efficacy of a Bioavailable Formulation of Curcumin With Fenugreek Dietary Fiber on Occupational Stress: A Randomized, Double-Blind, Placebo-Controlled Pilot Study.

    Science.gov (United States)

    Pandaran Sudheeran, Subash; Jacob, Della; Natinga Mulakal, Johannah; Gopinathan Nair, Gopakumar; Maliakel, Abhilash; Maliakel, Balu; Kuttan, Ramadasan; Im, Krishnakumar

    2016-06-01

    Drug delivery systems capable of delivering free (unconjugated) curcuminoids is of great therapeutic significance, since the absorption of bioactive and permeable form plays a key factor in mediating the efficacy of a substance which undergoes rapid biotransformation. Considering the recent understanding on the relatively high bioactivities and blood-brain-barrier permeability of free curcuminoids over their conjugated metabolites, the present human study investigated the safety, antioxidant efficacy, and bioavailability of CurQfen (curcumagalactomannoside [CGM]), a food-grade formulation of natural curcumin with fenugreek dietary fiber that has shown to possess improved blood-brain-barrier permeability and tissue distribution in rats. In this randomized double-blinded and placebo-controlled trial, 60 subjects experiencing occupational stress-related anxiety and fatigue were randomized to receive CGM, standard curcumin, and placebo for 30 days (500 mg twice daily). The study demonstrated the safety, tolerance, and enhanced efficacy of CGM in comparison with unformulated standard curcumin. A significant improvement in the quality of life (P comparison of the free curcuminoids bioavailability after a single-dose (500 mg once per day) and repeated-dose (500 mg twice daily for 30 days) oral administration revealed enhanced absorption and improved pharmacokinetics of CGM upon both single- (30.7-fold) and repeated-dose (39.1-fold) administrations.

  19. Double-blind, randomized pilot study of bioadhesive chlorhexidine gel in the prevention and treatment of mucositis induced by chemoradiotherapy of head and neck cancer.

    Science.gov (United States)

    Diaz-Sanchez, Rosa-Maria; Pachón-Ibáñez, Jerónimo; Marín-Conde, Fátima; Rodríguez-Caballero, Ángela; Gutierrez-Perez, Jose-Luis; Torres-Lagares, Daniel

    2015-05-01

    to evaluate, in an initial way, the effectiveness of bioadhesive chlorhexidine gel 0.2% versus placebo as a preventive and therapeutic intervention of oral mucositis induced by radiation therapy and chemotherapy in patients diagnosed with head and neck cancer treated with chemoradiotherapy. In this pilot study, 7 patients (range of age: 18- 65), having histological documented diagnosis of squamous carcinoma on the head and neck region in stage III and IV, and receiving combined radiation treatment and chemotherapy (cisplatin 100 mg/m2 IV on days 1, 22, and 43 of irradiation) were studied. Simultaneously, a topical application was performed with bioadhesive chlorhexidine gel 0.2% in the study group, and the placebo gel for the control group in 5 applications per day, from the time of initiation of cancer treatment to 2 weeks after completion of chemo-radiotherapy treatment (11 weeks of follow-up). The gradation of mucositis, pain, analgesic consumption, infectious complications, and treatment tolerance was measured. After 7 patients completed the protocol, any differences were observed between groups in an interval analysis. Mucositis, pain, and tolerance was similar in both groups. Our results must be interpreted with caution due to the reduced sample size, but the use of bioadhesive chlorhexidine gel 0.2% didn't contribute clinical improvement to the oral mucositis induced by radiation therapy and chemotherapy.

  20. The Efficacy of Treatment of Different Intervention Programs for Patellofemoral Pain Syndrome–A Single Blinded Randomized Clinical Trial. Pilot Study

    Directory of Open Access Journals (Sweden)

    Feazadeh Avraham

    2007-01-01

    Full Text Available Patello-femoral pain syndrome (PFPS is a common knee joint disability. The integration of hip soft tissue regimens are not always emphasized, although current literature implies that there is a significant relationship between the two and there is a lack of randomized clinical trials to substantiate this relationship in clinical practice. A randomized controlled assessor blinded trial was designed to explore different rehabilitation programs related to PFPS. The study was conducted at RAZIEL institute of physical therapy, Netania, Israel with a total of 30 consecutive patients (mean age 35y, diagnosed with PFPS. All patients were randomly allocated into 3 groups. Group I conventional knee rehabilitation program. Included quadriceps strengthening and Trans Electric Neuromuscular Stimulation (TENS. Group II hip oriented rehabilitation program. included stretching, Hip external rotators strengthening and TENS. Group III a combination of the two above programs. Pain and function were documented on initial of the program and again 3 weeks later, on the completion. Pain was assessed by a numeric visual analogue scale (VAS; function was assessed by Patello-femoral joint evaluation scale (PFJES (0-100 points. At end of trial, all groups showed significant improvements in VAS and PFJES (p<0.0001; these improvements did not vary significantly between the 3 groups. The conclusions were that the explored different rehabilitation programs showed a similar beneficial effect.

  1. A Pilot Study of the Effect of Aloe barbadensis Mill. Extract (AVH200®) in Patients with Irritable Bowel Syndrome: a Randomized, Double-Blind, Placebo-Controlled Study.

    Science.gov (United States)

    Størsrud, Stine; Pontén, Irina; Simrén, Magnus

    2015-09-01

    Few effective treatment options exist for patients with irritable bowel syndrome (IBS), and many patients state the use of aloe vera products reduce their symptoms. The aim of this pilot study was to investigate the effect of Aloe barbadensis Mill. Extract (AVH200®) in adult patients with IBS in a randomized, double-blind, placebo controlled study. Sixty-eight adult patients diagnosed with IBS according to the Rome III criteria were randomized to receive AVH200® or matching placebo for four weeks. Symptom questionnaires were completed on a weekly basis and the patients were asked if they had had adequate relief of their gastrointestinal symptoms. A tendency towards a higher proportion of responders in the aloe vera group (55%) vs. placebo (31%), (p=0.09) was observed, and the proportion of subjects who reported adequate relief at least 50% of the weeks during the treatment period tended to be larger in the aloe vera vs. placebo group (33% vs. 14%; p=0.12). The overall severity of the gastrointestinal symptoms was reduced in the aloe vera group (314+/-83 vs. 257+/-107; p=0.003) but not the placebo group (276+/-88 vs. 253+/-100; NS), without difference between the groups (p=0.10). AVH200® was well tolerated and no serious adverse events were observed. Even though the primary endpoint was not met, AVH200® seems to be a promising treatment option for patients with IBS owing to the positive results seen within the secondary endpoints. This study may have been underpowered to detect a clinically meaningful difference between the treatment groups, and therefore larger randomized, controlled studies are required to confirm these results and to elucidate potential mechanisms explaining its effect.

  2. Double-Blind Randomized Controlled Trial: Injection of Autologous Blood in the Treatment of Chronic Patella Tendinopathy-A Pilot Study.

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    Resteghini, Peter; Khanbhai, Tamim A; Mughal, Shabaaz; Sivardeen, Ziali

    2016-01-01

    To assess the efficacy of autologous blood injections (ABIs) against saline in patients with chronic recalcitrant patella tendinopathy (PT). Double-blind randomized controlled study. Homerton Hospital Sports Medicine department. Those with a diagnosis of refractory patellar tendinopathy were recruited between March 2010 and March 2012. Using 2 practitioners, patients were randomized to either receive ABIs or saline injections. All patients completed the Short-Form McGill Pain Questionnaire (MPQ), a visual analog scale (VAS), and a Victoria Institute of Sport Assessment for Patella Tendinopathy scale over a 12-month period. Twenty-two patients completed the final review at 12 months and were included in the study. Subjects ranged in age from 22 and 61 years and were randomized to 11 in each ABI and saline groups. Autologous blood injection group had a mean duration of symptoms of 16.7 months, whereas that of the saline group was 19.2 months. The saline group mean VAS score was reduced from 7.9 to 4.5 at 1 month (P = 0.003) and 3.3 (P = 0.005) at 1 year. With ABI, the score was reduced from 7.5 to 4.5 (P = 0.005) at 1 month and 3.1 (P = 0.003) at 1 year. Victoria Institute of Sport Assessment for Patella Tendinopathy, MPQ, and VAS scores improved significantly in both groups. This study demonstrated that both the ABI and saline groups experienced a significant improvement in symptoms. However, when the results were compared, there was no statistical difference between the 2 groups. This research showed that tendon fenestration is an alternative cost-effective treatment for recalcitrant PT.

  3. A randomized placebo-controlled double-blind pilot study of methotrexate in the treatment of H1 antihistamine-resistant chronic spontaneous urticaria

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    Vinod K Sharma

    2014-01-01

    Full Text Available Background: Chronic urticaria not responsive to antihistamines is a difficult disease to manage. Methotrexate has been used in difficult chronic urticarias with some benefit. Objective: To evaluate the efficacy of methotrexate in the treatment of chronic spontaneous urticaria poorly responsive to H1 antihistaminics. Methods: In a randomized double-blind trial at the Department of Dermatology and Venereology of a tertiary care centre, 29 patients with chronic spontaneous urticaria not responding well to H1 antihistaminics were recruited. Patients were randomly allocated to receive either a weekly dose of oral methotrexate 15 mg or placebo (calcium carbonate for a total duration of 12 weeks, after which treatment was stopped and patients were followed up for relapse of urticaria. Each group also received levocetrizine 5 mg once daily for symptom control. Primary outcome measured was a reduction by >2/3 rd of baseline urticaria scores after 12 week therapy. Secondary outcome was a reduction in antihistamine requirement after stopping therapy. Results: Fourteen patients were randomized to the methotrexate group and fifteen patients to the placebo group. Out of 17 patients who completed therapy, the primary outcome was achieved by 3.5 ± 1.9 (out of 10 patients in the methotrexate group and by 3.67 ± 1.03 (out of 7 patients in the placebo group (P > 0.05. Ten patients followed up, after stopping therapy, for a mean period of 3.5 ± 2.4 months; 3 remained in remission and 7 had relapsed. One patient had uncontrollable nausea and vomiting after taking methotrexate and was withdrawn from the study. The placebo group did not experience any side effects. Conclusions: Methotrexate 15 mg weekly for 3 months did not provide any additional benefit over H1 antihistamines in this study but an adequately powered study with longer follow up is required to assess its utility.

  4. Microbial field pilot study

    Energy Technology Data Exchange (ETDEWEB)

    Knapp, R.M.; McInerney, M.J.; Menzie, D.E.; Coates, J.D.; Chisholm, J.L.

    1993-05-01

    A multi-well microbially enhanced oil recovery field pilot has been performed in the Southeast Vassar Vertz Sand Unit in Payne County, Oklahoma. The primary emphasis of the experiment was preferential plugging of high permeability zones for the purpose of improving waterflood sweep efficiency. Studies were performed to determine reservoir chemistry, ecology, and indigenous bacteria populations. Growth experiments were used to select a nutrient system compatible with the reservoir that encouraged growth of a group of indigenous nitrate-using bacteria and inhibit growth of sulfate-reducing bacteria. A specific field pilot area behind an active line drive waterflood was selected. Surface facilities were designed and installed. Injection protocols of bulk nutrient materials were prepared to facilitate uniform distribution of nutrients within the pilot area. By the end of December, 1991, 82.5 tons (75.0 tonnes) of nutrients had been injected in the field. A tracer test identified significant heterogeneity in the SEVVSU and made it necessary to monitor additional production wells in the field. The tracer tests and changes in production behavior indicate the additional production wells monitored during the field trial were also affected. Eighty two and one half barrels (13.1 m[sup 3]) of tertiary oil have been recovered. Microbial activity has increased CO[sub 2] content as indicated by increased alkalinity. A temporary rise in sulfide concentration was experienced. These indicate an active microbial community was generated in the field by the nutrient injection. Pilot area interwell pressure interference test results showed that significant permeability reduction occurred. The interwell permeabilities in the pilot area between the injector and the three pilot production wells were made more uniform which indicates a successful preferential plugging enhanced oil recovery project.

  5. An adaptogenic role for omega-3 fatty acids in stress; a randomised placebo controlled double blind intervention study (pilot [ISRCTN22569553

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    Myers Stephen P

    2004-11-01

    Full Text Available Abstract Background There is evidence for an adaptive role of the omega -3 fatty acid, docosahexaenoic acid (DHA during stress. Mechanisms of action may involve regulation of stress mediators, such as the catecholamines and proinflammatory cytokines. Prevention of stress-induced aggression and hostility were demonstrated in a series of clinical trials. This study investigates whether perceived stress is ameliorated by DHA in stressed university staff. Methods Subjects that scored ≥ 17 on the Perceived Stress Scale were randomised into a 6-week pilot intervention study. The diet reactive group was supplemented with 6 g of fish oil containing 1.5 g per day DHA, while the placebo group was supplemented with 6 g a day of olive oil. The groups were compared with each other and a wider cross sectional study population that did not receive either active or placebo intervention. Results There was a significant reduction in perceived stress in both the fish oil and the placebo group from baseline. There was also a significant between-group difference between the fish oil group and the no-treatment controls in the rate of stress reduction (p These results are discussed in the context of several methodological limitations. The significant stress reductions in both the fish oil and the placebo group are considered in view of statistical regression, an effect likely to have been exaggerated by the time course of the study, a large placebo effect and the possibility of an active effect from the placebo. Conclusion There were significant differences (p

  6. The effect of balneotherapy on chronic shoulder pain. A randomized, controlled, single-blind follow-up trial. A pilot study.

    Science.gov (United States)

    Tefner, Ildikó Katalin; Kovács, Csaba; Gaál, Ramóna; Koroknai, András; Horváth, Remény; Badruddin, Rakib Mohammed; Borbély, Ildikó; Nagy, Katalin; Bender, Tamás

    2015-06-01

    The effects of balneotherapy on chronic shoulder pain were studied. In this single-blind, randomized, follow-up study involving 46 patients with chronic shoulder pain, one group of patients received physiotherapy--exercise and transcutaneous electrical nerve stimulation--and the other group received balneotherapy in addition to physiotherapy for 4 weeks on 15 occasions. The following parameters were recorded before treatment (at week 0) and after treatment (at weeks 4, 7, and 13): Shoulder Pain and Disability Index (SPADI), the Short Form (36) Health Survey (SF-36) and EuroQuol-5D (EQ-5D) quality of life questionnaires, pain at rest and on movement on the visual analog scale (VAS), and active and passive range of motion. The SPADI pain, function, and total scores and the VAS scores at rest and on movement significantly improved in both groups after treatments. A greater improvement was observed in the balneotherapy group compared to the control group; regarding some parameters (VAS score on movement and SPADI function score at visit 2; VAS score at rest at visits 3 and 4), the difference between the groups was significant. The improvement of SF-36 and EQ-5D quality of life scores and the active range of motion was more pronounced in the balneotherapy group, the difference between the groups was not significant, except for EQ-5D at visit 2. Improvement of passive range of motion was not significant. Balneotherapy may have a beneficial effect on the clinical parameters and quality of life of patients with chronic shoulder pain. The number of patients should be increased.

  7. Betalain-rich red beet concentrate improves reduced knee discomfort and joint function: a double blind, placebo-controlled pilot clinical study

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    Pietrzkowski Z

    2014-03-01

    Full Text Available Zbigniew Pietrzkowski,1 Ruby Argumedo,1 Cynthia Shu,1 Boris Nemzer,2 Slawomir Wybraniec,3 Tania Reyes-Izquierdo1 1Applied BioClinical Inc., Irvine, CA, USA; 2FutureCeuticals Inc., Momence, IL, USA; 3Department of Analytical Chemistry, Institute C-1, Faculty of Chemical Engineering and Technology, Cracow University of Technology, Cracow, Poland Aim: We aimed to evaluate the effect of a betalain-rich red beet concentrate (BRC on joint discomfort and joint function. Methods: Individuals with self-reported knee discomfort were randomized and blinded to treatment with either oral BRC (50 mg twice a day or placebo. Symptoms of discomfort and joint function were assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC and the McGill Pain Questionnaire (MPQ before treatment and after 5 and 10 days of treatment. The general level of energy was evaluated using a visual analog scale (VAS at the same time points. Results: In all, 40 individuals were evaluated in this study, 20 in the BRC group and 20 in the placebo group. The mean participant age was 55 years (range: 45–65. All participants completed the study. Individuals receiving BRC had a 27% better MPQ score after 10 days than did individuals in the placebo group (P=0.003. Furthermore, knee function, as measured by WOMAC score, was 26% better in the BRC group than in the placebo group (P<0.0013. Participants receiving BRC had a significantly better VAS score for energy after 5 (P=0.002 and 10 days (P=0.012 of treatment than did individuals receiving placebo. Conclusion: Short-term use of BRC in individuals with knee discomfort significantly improved knee discomfort and joint function, as measured by WOMAC and MPQ scores, and energy, as measured by a VAS. Keywords: arthritis, visual analog scale, Western Ontario and McMaster Universities Arthritis Index, McGill Pain Questionnaire, red beet roots

  8. Clinical evaluation of XaraColl®, a bupivacaine-collagen implant, for postoperative analgesia in two multicenter, randomized, double-blind, placebo-controlled pilot studies

    Directory of Open Access Journals (Sweden)

    Cusack SL

    2012-06-01

    Full Text Available Susan L Cusack,1 Mark Jaros,2 Michael Kuss,3 Harold S Minkowitz,4 Peter Winkle,5 Lisa Hemsen61Cusack Pharmaceutical Consulting, Burlington, NJ, 2Summit Analytical, Denver, CO, USA; 3Premier Research Group, Austin, TX, USA; 4Memorial Hermann Memorial City Medical Center, Houston, TX, USA; 5Advanced Clinical Research Institute, Anaheim, CA, USA; 6Innocoll Technologies, Athlone, IrelandBackground: XaraColl®, a collagen-based implant that delivers bupivacaine to the site of surgical trauma, is under development for postoperative analgesia. Because of differing patient attitudes to postoperative pain control and the inability to assess baseline pain, standard clinical methods for evaluating analgesic efficacy are compromised and justify application of novel integrated approaches.Methods: We conducted two independent, multicenter, double-blind, placebo-controlled studies in men undergoing unilateral inguinal hernioplasty by open laparotomy to evaluate the safety and efficacy of XaraColl at different doses (100 mg and 200 mg of bupivacaine hydrochloride; study 1 and 2, respectively. Enrolled patients (50 in study 1 and 53 in study 2 were randomized to receive active or placebo implants in a 1:1 ratio. Postoperative pain intensity and use of supplementary opioid medication were recorded through 72 hours. Safety was assessed through 30 days. The principal efficacy variables were the summed pain intensity (SPI, total use of opioid analgesia (TOpA, and an integrated endpoint (I-SPI-TOpA. Each variable was analyzed at 24, 48, and 72 hours after implantation. A pooled analysis of both studies was also performed retrospectively.Results: Through 24 and 48 hours, XaraColl-treated patients experienced significantly less pain in study 1 (P < 0.001 and P = 0.012, respectively whereas they took significantly less opioid analgesia in study 2 (P = 0.004 and P = 0.042, respectively. Over the same time intervals in the pooled analysis, treated patients experienced

  9. Bacillus coagulans MTCC 5856 supplementation in the management of diarrhea predominant Irritable Bowel Syndrome: a double blind randomized placebo controlled pilot clinical study.

    Science.gov (United States)

    Majeed, Muhammed; Nagabhushanam, Kalyanam; Natarajan, Sankaran; Sivakumar, Arumugam; Ali, Furqan; Pande, Anurag; Majeed, Shaheen; Karri, Suresh Kumar

    2016-02-27

    Bacillus coagulans MTCC 5856 has been marketed as a dietary ingredient, but its efficacy in diarrhea predominant irritable bowel syndrome (IBS) condition has not been clinically elucidated till date. Thus, a double blind placebo controlled multi-centered trial was planned to evaluate the safety and efficacy of B. coagulans MTCC 5856 in diarrhea predominant IBS patients. Thirty six newly diagnosed diarrhea predominant IBS patients were enrolled in three clinical centres. Along with standard care of treatment, 18 patients in group one received placebo while in group two 18 patients received B. coagulans MTCC 5856 tablet containing 2 × 10(9) cfu/day as active for 90 days. Clinical symptoms of IBS were considered as primary end point measures and were evaluated through questionnaires. The visual analog scale (VAS) was used for abdominal pain. Physician's global assessment and IBS quality of life were considered as secondary efficacy measures and were monitored through questionnaires. Laboratory parameters, anthropometric and vital signs were within the normal clinical range during the 90 days of supplementation in placebo and B. coagulans MTCC 5856 group. There was a significant decrease in the clinical symptoms like bloating, vomiting, diarrhea, abdominal pain and stool frequency in a patient group receiving B. coagulans MTCC 5856 when compared to placebo group (p coagulans MTCC 5856 when compared to placebo group. The study concluded that the B. coagulans MTCC 5856 at a dose of 2 × 10(9) cfu/day along with standard care of treatment was found to be safe and effective in diarrhea predominant IBS patients for 90 days of supplementation. Hence, B. coagulans MTCC 5856 could be a potential agent in the management of diarrhea predominant IBS patients.

  10. Andrographis paniculata decreases fatigue in patients with relapsing-remitting multiple sclerosis: a 12-month double-blind placebo-controlled pilot study.

    Science.gov (United States)

    Bertoglio, J C; Baumgartner, M; Palma, R; Ciampi, E; Carcamo, C; Cáceres, D D; Acosta-Jamett, G; Hancke, J L; Burgos, R A

    2016-05-23

    Andrographis paniculata (A. paniculata), a medicinal plant, has shown anti-inflammatory, neuroprotective and antifibrotic effects in animal models as well as clinical efficacy in different studies, including an anti-fatigue effect in autoimmune diseases such as rheumatoid arthritis. In multiple sclerosis (MS), fatigue is rated as one of the most common and disabling symptoms. In the present trial, we investigated the effect of A. paniculata on relapse rate and fatigue in relapsing-remitting MS (RRMS) patients receiving interferon beta. A randomised double-blind placebo-controlled trial assessed the effects of 170 mg of A. paniculata dried extract tablet b.i.d. p.o. on relapse rate and fatigue using the Fatigue Severity Scores (FSS) over 12 months in RRMS patients receiving interferon. The Expanded Disability Status Scale (EDSS) score, inflammatory parameters and radiological findings were also investigated. Twenty-five patients were enrolled, and twenty-two patients were ultimately analysed and randomised to the active or placebo group. Patients treated with A. paniculata showed a significant reduction in their FSS score as compared to the placebo, equivalent to a 44 % reduction at 12 months. No statistically significant differences were observed for relapse rate, EDSS or inflammatory parameters, with a trend in reducing new lesions among the A. paniculata group. One patient in the A. paniculata group presented with a mild and transient skin rash, which was alleviated with anti-histamine treatment for three weeks. A. paniculata was well tolerated in patients and no changes in clinical parameters were observed. A. paniculata significantly reduces fatigue in patients with RRMS receiving interferon beta in comparison to placebo and only interferon beta treatment. ClinicalTrials.gov Identifier: NCT02280876 ; Trial registration date: 20.10.2014.

  11. The Effect of Bee Venom Acupuncture(BVA on acute Ankle Sprain : A Randomized Controlled Trial and double blinding - Pilot study

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    Song, Ho-Seub

    2005-06-01

    Full Text Available Objective : The aim of the study was to investigate the therapeutic effect of BVA in the treatment of patients with acute ankle sprain. Design : A prospective randomized double-blind study of BVA was conducted. Setting : The study was done in the Kyungwon University Seoul Hospital from August 1st, 2004 to June 15th, 2005. Patients : 30 patients diagnosed with acute ankle sprain, especially 2nd degree on the Ankle grade pain chart(AGPC participated in the study, who were divided into two groups (A and B randomly by a coordinator flipping a coin. Group A and B were relevant to control and BVA group respectively, of which a coordinator never informed any other participant involved. eventually 13 of 17 in group A and 11 of 13 in Group B finished all the process of the clinical trial. Intervention : In both group A and B, The Procedure of acupuncture treatment was made similar by appearance that four acupoints such as 坵墟(GB40, 中封(LR4, 商丘(SP5, 解谿(ST41 of the injured side were selected and Normal saline aqua-acupuncture(control, as a placebo or BVA was done and then acupuncture at 坵墟(GB40, 中封(LR4, 商丘(SP5, 解谿(ST41, 足三里(ST36, 陽陵泉(G34 of the affected side was given again. the needles were retained for 20 minutes under the infrared rays. The treatment was given daily for a week. Outcome Measures : Ankle-Hindfoot Scale (AHS and Visual Analogue Scale(VAS were followed by three treatments. Statistical Analysis : Analysis regarding variations in AHS and VAS is carried out by applying Mann-Whitney test and Wilcoxon signed rank test sign test with level of significance at 5%. Results : At the end of the treatment, there was significant statistical differences between the two groups in VAS and AHS as well, while at the 3rd day only a VAS showed statistical significance. In each group, both VAS and AHS showed statistical significance along with duration of treatment. Conclusions : BVA was thought to be effective

  12. Efficacy and Safety of MLC601 in the Treatment of Mild Cognitive Impairment: A Pilot, Randomized, Double-Blind, Placebo-Controlled Study

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    Hossein Pakdaman

    2017-05-01

    Full Text Available Background and Aim: Mild cognitive impairment (MCI is characterized by declined cognitive function greater than that expected for a person’s age. The clinical significance of this condition is its possible progression to dementia. MLC601 is a natural neuroprotective medication that has shown promising effects in Alzheimer disease. Accordingly, we conducted this randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of MLC601 in MCI patients. Methods: Seventy-two patients with a diagnosis of MCI were recruited. The included participants were randomly assigned to groups to receive either MLC601 or placebo. An evaluation of global cognitive function was performed at baseline as well as at 3-month and 6-month follow-up visits. Global cognitive function was assessed by Mini-Mental State Examination (MMSE and Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog scores. Efficacy was evaluated by comparing global function scores between the 2 groups during the study period. Safety assessment included adverse events (AEs and abnormal laboratory results. Results: Seventy patients completed the study, 34 in the MLC601 group and 36 in the placebo group. The mean changes (±SD in cognition scores over 6 months in the MLC601 group were –2.26 (±3.42 for the MMSE and 3.82 (±6.16 for the ADAS-cog; in the placebo group, they were –2.66 (±3.43 for the MMSE and 4.41 (±6.66 for the ADAS-cog. The cognition changes based on both MMSE and ADAS-cog scores were statistically significant between the placebo and the MLC601 group (p < 0.001. Only 5 patients (14.7% reported minor AEs in the MLC601 group, the most commonly reported of which were gastrointestinal, none of them leading to patient withdrawal. Conclusion: MLC601 has shown promising efficacy and acceptable AEs in MCI patients.

  13. A pilot double-blind, randomized, placebo-controlled trial of the efficacy of trace elements in the treatment of endometriosis-related pain: study design and methodology

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    Oberweis D

    2016-02-01

    Full Text Available Didier Oberweis,1 Patrick Madelenat,2 Michelle Nisolle,3 Etienne Demanet4 1Department of Gynecology and Obstetrics, CHU de Charleroi, Hôpital André Vésale, Montigny-le-Tilleul, Belgium; 2Private Consultation, Paris, France; 3Department of Gynecology and Obstetrics, CHR Citadelle, Liège, 4Clinical Research Unit, Charleroi, Belgium Abstract: Endometriosis is one of the most common benign gynecological disorders, affecting almost 10%–15% of all women of reproductive age and >30% of infertile women. The pathology is associated with various distressing symptoms, particularly pelvic pain, which adversely affect patients' quality of life. It is an estrogen-dependent disease. There is evidence both in animals and in humans that metal ions can activate the estrogen receptors. They are defined as a variety of xenoestrogens, called metalloestrogens, which could act as endocrine disruptors. Therefore, it could be considered to act on this gynecological disorder using food supplements containing trace elements (ie, nutripuncture. The assumption is that they could modulate estrogen receptors and thus influence the tropism and the survival of cells involved in endometriosis. By a modulation of the antioxidant system, they might also interact with various parameters influencing tissue biochemistry. The objective of this article is to describe and discuss the design and methodology of an ongoing double-blind, randomized, placebo-controlled study aiming to evaluate the efficacy of metal trace elements on the reduction of pain and improvement of quality of life, in patients with a revised American Fertility Society Score Stages II–IV endometriosis, combined or not with adenomyosis, during a treatment period of 4 months. Trace elements or placebo is proposed in the absence of any other treatment or as an add-on to current therapies, such as sexual hormones, nonsteroidal anti-inflammatory drugs, and surgery. A placebo run-in period of one menstrual cycle or

  14. The ENIQ pilot study: current status

    Energy Technology Data Exchange (ETDEWEB)

    Lemaitre, P.; Eriksen, B.; Crutzen, S. [European Commission, DG Joint Research Centre, Petten (Netherlands); Hansch, M. [Preussische Elektrizitaets-AG (Preussenelektra), Hannover (Germany); Whittle, J. [AEA Technology, Warrington (United Kingdom)

    1998-11-01

    A pilot study is currently being carried out by ENIQ (European Network for Inspection Qualification) in order to explore the issues involved in inspection qualification applied along the general principles of the European methodology. The components selected for the pilot study are austenitic pipe to pipe and pipe to elbows welds typical of those in BWR recirculation loops. A range of defect parameters has been defined. A suitable inspection procedure designed to find the designated defects will be applied to geometrically representative test pieces. The procedure/equipment will be qualified through open trials and technical justification. The personnel qualification will be done in a blind way. Once all features of the inspection system will have been qualified an in-service inspection will be simulated in order to test the feasibility of the qualification approach followed. In this paper the current status of this pilot study is discussed. (orig.)

  15. A pilot study to evaluate the effect of Taeumjowi-tang on obesity in Korean adults: study protocol for a randomised, double-blind, placebo-controlled, multicentre trial.

    Science.gov (United States)

    Park, Sunju; Park, Jeong-Su; Cheon, ChunHoo; Yang, Yong Joon; An, Changsuk; Jang, Bo-Hyoung; Song, Yun-Kyung; Go, Hoyeon; Lee, Ju Ah; Shin, Yongcheol; Ko, Seong-Gyu

    2012-04-07

    Obesity, which is described as excessive or abnormal body fat, increases the risk of diet-related diseases. In Korea and around the world, the prevalence of obesity has grown annually from 1998 to 2008. This growth has continued despite various therapeutic efforts. The discovery of new and alternative treatments for obesity should be considered an important priority. Taeumjowi-tang (TJ001), a traditional Korean medicinal extract consisting of eight herbs, is a widely used herbal remedy for obesity in Korea. However, the efficacy and safety of TJ001 have not been fully investigated in a clinical trial. The purpose of this pilot study is to estimate obesity-related parameters and to assess the efficacy and safety of TJ001. Our study is a randomised, double-blind, placebo-controlled, multicentre clinical trial of Taeumjowi-tang (TJ001). For this study, we will recruit obese Korean patients of both sexes, ages 18 to 65 years, from four university hospitals. A total of 104 subjects will be recruited. The participants will receive either 7 g of TJ001 or a placebo three times daily for 12 weeks. The primary end point will be the rate of subjects who lose at least 5% of their baseline body weight. The secondary end points will be changes in body weight, body mass index, waist circumference, hip circumference, waist/hip circumference ratio, lipid profiles, body fat composition, blood pressure, fasting glucose concentration, C-reactive protein and questionnaires related to the quality of life. The outcomes will be measured every 4 weeks. The study period will be 12 weeks and will include a total of five visits with each subject (at screening and at 0, 4, 8 and 12 weeks). The results of our study will inform various estimates of TJ001 and will serve as the basis for a larger-scale trial. This study will assess the efficacy and safety of TJ001 as an alternative herbal remedy for obesity. Current Controlled Trials ISRCTN87153759.

  16. Bismuth adjuvant ameliorates adverse effects of high-dose chemotherapy in patients with multiple myeloma and malignant lymphoma undergoing autologous stem cell transplantation: a randomised, double-blind, prospective pilot study.

    Science.gov (United States)

    Hansen, Per Boye; Penkowa, Milena

    2017-04-01

    High-dose chemotherapy prior to autologous stem cell transplantation (ASCT) leads to adverse effects including mucositis, neutropenia and bacteremia. To reduce the toxicity, we treated myeloma and lymphoma patients with peroral bismuth as an adjuvant to chemotherapy to convey cytoprotection in non-malignant cells. This trial was a prospective, randomised, double-blind, placebo-controlled pilot study of hematological inpatients (n = 50) receiving bismuth or placebo tablets, in order to identify any potential superiority of bismuth on toxicity from chemotherapy. We show for the first time that bismuth significantly reduces grade 2 stomatitis, febrile neutropenia and infections caused by melphalan in multiple myeloma, where adverse effects also were significantly linked to gender. In lymphoma patients, bismuth significantly reduces diarrhoea relative to placebo. Also, lymphoma patients' adverse effects were linked to gender. For the first time, bismuth is demonstrated as a safe strategy against chemotherapy's toxicity without interfering with intentional anti-cancer efficiency. Also, we show how gender significantly influences various adverse effects and response to treatment in both multiple myeloma and malignant lymphomas. These results may impact clinical prevention of chemotherapy's cytotoxicity in certain patient groups, and also, this study may direct further attention towards the impact of gender during the course and treatment outcome of malignant disorders.

  17. Resveratrol exerts no effect on inflammatory response and delayed onset muscle soreness after a marathon in male athletes.: A randomised, double-blind, placebo-controlled pilot feasibility study.

    Science.gov (United States)

    Laupheimer, M W; Perry, M; Benton, S; Malliaras, P; Maffulli, N

    2014-09-01

    We investigated whether the inflammatory response and delayed onset of muscle soreness after a marathon are altered by resveratrol, a natural polyphenolic flavonoid antioxidant. Double blind placebo-controlled randomised pilot study. London Marathon. Marathon race participants. 7 healthy male athletes were randomised to receive Resveratrol (600 mg Resveratrol daily for 7 days immediately before the marathon) or a placebo. Blood samples taken 48 hours before and 18-32 hours after the marathon were analysed for white blood cell count (WBC) and C-reactive protein (CRP). A VAS score was taken at the same times as the blood samples to assess delayed onset muscle soreness. There were no significant differences between the two groups in terms of changes occurring between pre- and post- tests for WBC, CRP or VAS. There were no differences in immune response or delayed onset muscle soreness between resveratrol and placebo after a marathon. Further investigations are needed with longer treatment time and higher doses, analysing additional parameters such interleukins for a possible effect of resveratrol on the inflammatory response due to extensive exercise. To avoid a type II error, 17 subjects in each group would be required.

  18. Pilot study: a randomised, double blind, placebo controlled trial of pancrealipase for the treatment of postprandial irritable bowel syndrome-diarrhoea.

    Science.gov (United States)

    Money, Mary E; Walkowiak, Jaroslaw; Virgilio, Chris; Talley, Nicholas J

    2011-01-01

    OBJECTIVE: To evaluate the efficacy of pancrealipase (PEZ) compared with placebo in the reduction of postprandial irritable bowel syndrome-diarrhoea (IBS-D). DESIGN: An intention to treat, double blind, randomised, crossover trial comparing PEZ to placebo for reduction of postprandial IBS-D. Patients had to recognise at least two different triggering foods, be willing to consume six baseline 'trigger meals' and again blinded with PEZ and placebo. Patients then chose which drug they preferred for another 25 meals. SETTING: Outpatient internal medicine practice clinic. PATIENTS: 255 patients were screened; 83 met the criteria, including 5 years of symptoms, recognised 'food triggers', no other identifiable cause for the symptoms, either a normal colonoscopy or barium enema while symptomatic and able to discontinue all anticholinergic medications. 69 patients were enrolled, 20 withdrew before randomisation, leaving 49 patients: 14 men, 35 women, mean age 52 years (SD 15.3). Over 60% had experienced symptoms for 11-30 years and 16% for more than 40 years. INTERVENTIONS: After completing six baseline meals, patients were randomised in blocks of four to receive either identical PEZ or a placebo for another six meals, and after a washout period of time received the alternative drug. MAIN OUTCOME MEASURES: The primary analysis was number of patients who chose PEZ over placebo for the extended use. RESULTS: Overall, 30/49 (61%) would have chosen PEZ (p=0.078), with first drug preference for PEZ at 0.002. Among the PEZ subgroup, PEZ use compared with placebo, demonstrated improvement in all symptoms (p≤0.001) for cramping, bloating, borborygami, urge to defecate, global pain and decrease stooling with increase in stool firmness. CONCLUSIONS: PEZ was found in a small group of patients to reduce postprandial IBS-D symptoms and deserves further evaluation.

  19. 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…

  20. Randomized double-blind controlled clinical trial of the blood pressure-lowering effect of fermented milk with Lactococcus lactis: A pilot study.

    Science.gov (United States)

    Beltrán-Barrientos, Lilia M; González-Córdova, Aarón F; Hernández-Mendoza, Adrián; Torres-Inguanzo, Eduardo H; Astiazarán-García, Humberto; Esparza-Romero, Julián; Vallejo-Cordoba, Belinda

    2018-04-01

    The blood pressure-lowering effect of fermented milk with Lactococcus lactis NRRL B-50571 was evaluated in a double-blind randomized controlled clinical trial with prehypertensive subjects. Participants were randomized into 2 groups (n = 18 each group): one group treated with fermented milk with Lactococcus lactis NRRL B-50571 and a control group treated with artificially acidified milk. Results revealed that during daily consumption of fermented milk for 5 wk, systolic [(116.55 ± 12.26 mmHg vs. 124.77 ± 11.04 mmHg) and diastolic blood pressure (80.7 ± 9 vs. 84.5 ± 8.5 mmHg)] from the fermented milk group was lower than the control group. Additionally, triglyceride, total cholesterol, and low-density lipoprotein in blood serum were lower in the fermented milk group than in the control group. Results demonstrated that daily consumption of fermented milk with Lactococcus lactis (NRRL B-50571) had a blood pressure-lowering effect on prehypertensive subjects. Regular consumption of this product may be used as a potential functional food. Copyright © 2018 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

  1. A Randomised, Double-Blind Pilot Study of Enzyme-Potentiated Desensitisation for Prophylaxis of Large Local Reactions to Mosquito Bites

    Directory of Open Access Journals (Sweden)

    S. Berkovitz

    2012-01-01

    Full Text Available Primary Objective. To test the hypothesis that two injections of enzyme-potentiated mosquito antigen significantly reduce the size of experimental mosquito bites in participants with LLR-MB. Design. Randomised, double-blind, placebo-controlled, parallel group comparison over 3 months. Setting. Hospital outpatient clinic. Participants. Fifty adult participants of both sexes. Interventions. Two injections of mosquito antigen or matching placebo, 6 weeks apart. Main Outcome Measures. Early (1 hour and late (24 hours mean square root of erythema area (SREA following controlled mosquito bite with the second bite given at least 6 weeks following the final injection. Results. At 1 hour, mean SREA was slightly higher in the EPD group compared to placebo after adjusting for baseline values (0.46, 95% CI −6.11 to 7.03, but this was not statistically significant (P=0.89, ANCOVA analysis; neither were the results at 24 hours (−2.58, 95% CI −11.73 to 6.57 (P=0.57. The proportion of participants experiencing a decrease in wheal size at 1 or 24 hours was similar between groups. Conclusions. EPD was not demonstrated to be effective for immediate or delayed LLR-MB. Methodological problems included a high variability in LLR-MB between subjects, suggesting that a crossover design should be used in future.

  2. Microbial Field Pilot Study

    Energy Technology Data Exchange (ETDEWEB)

    Knapp, R.M.; McInerney, M.J.; Menzie, D.E.; Chisholm, J.L.

    1990-11-01

    This report covers progress made during the first year of the Microbial Field Pilot Study project. Information on reservoir ecology and characterization, facility and treatment design, core experiments, bacterial mobility, and mathematical modeling are addressed. To facilitate an understanding of the ecology of the target reservoir analyses of the fluids which support bacteriological growth and the microbiology of the reservoir were performed. A preliminary design of facilities for the operation of the field pilot test was prepared. In addition, procedures for facilities installation and for injection treatments are described. The Southeast Vassar Vertz Sand Unit (SEVVSU), the site of the proposed field pilot study, is described physically, historically, and geologically. The fields current status is presented and the ongoing reservoir simulation is discussed. Core flood experiments conducted during the last year were used to help define possible mechanisms involved in microbial enhanced oil recovery. Two possible mechanisms, relative permeability effects and changes in the capillary number, are discussed and related to four Berea core experiments' results. The experiments were conducted at reservoir temperature using SEVVSU oil, brine, and bacteria. The movement and activity of bacteria in porous media were investigated by monitoring the growth of bacteria in sandpack cores under no flow conditions. The rate of bacteria advancement through the cores was determined. A mathematical model of the MEOR process has been developed. The model is a three phase, seven species, one dimensional model. Finite difference methods are used for solution. Advection terms in balance equations are represented with a third- order upwind differencing scheme to reduce numerical dispersion and oscillations. The model is applied to a batch fermentation example. 52 refs., 26 figs., 21 tabs.

  3. Microbial field pilot study

    Energy Technology Data Exchange (ETDEWEB)

    Knapp, R.M.; McInerney, M.J.; Menzie, D.E.; Chisholm, J.L.

    1992-03-01

    The objective of this project is to perform a microbial enhanced oil recovery field pilot in the Southeast Vassar Vertz Sand Unit (SEVVSU) in Payne County, Oklahoma. Indigenous, anaerobic, nitrate reducing bacteria will be stimulated to selectively plug flow paths which have been referentially swept by a prior waterflood. This will force future flood water to invade bypassed regions of the reservoir and increase sweep efficiency. This report covers progress made during the second year, January 1, 1990 to December 31, 1990, of the Microbial Field Pilot Study project. Information on reservoir ecology, surface facilities design, operation of the unit, core experiments, modeling of microbial processes, and reservoir characterization and simulation are presented in the report. To better understand the ecology of the target reservoir, additional analyses of the fluids which support bacteriological growth and the microbiology of the reservoir were performed. The results of the produced and injected water analysis show increasing sulfide concentrations with respect to time. In March of 1990 Mesa Limited Partnership sold their interest in the SEVVSU to Sullivan and Company. In April, Sullivan and Company assumed operation of the field. The facilities for the field operation of the pilot were refined and implementation was begun. Core flood experiments conducted during the last year were used to help define possible mechanisms involved in microbial enhanced oil recovery. The experiments were performed at SEVVSU temperature using fluids and inoculum from the unit. The model described in last year's report was further validated using results from a core flood experiment. The model was able to simulate the results of one of the core flood experiments with good quality.

  4. Microbial field pilot study

    Energy Technology Data Exchange (ETDEWEB)

    Knapp, R.M.; McInerney, M.J.; Menzie, D.E.; Chisholm, J.L.

    1992-03-01

    The objective of this project is to perform a microbial enhanced oil recovery field pilot in the Southeast Vassar Vertz Sand Unit (SEVVSU) in Payne County, Oklahoma. Indigenous, anaerobic, nitrate reducing bacteria will be stimulated to selectively plug flow paths which have been referentially swept by a prior waterflood. This will force future flood water to invade bypassed regions of the reservoir and increase sweep efficiency. This report covers progress made during the second year, January 1, 1990 to December 31, 1990, of the Microbial Field Pilot Study project. Information on reservoir ecology, surface facilities design, operation of the unit, core experiments, modeling of microbial processes, and reservoir characterization and simulation are presented in the report. To better understand the ecology of the target reservoir, additional analyses of the fluids which support bacteriological growth and the microbiology of the reservoir were performed. The results of the produced and injected water analysis show increasing sulfide concentrations with respect to time. In March of 1990 Mesa Limited Partnership sold their interest in the SEVVSU to Sullivan and Company. In April, Sullivan and Company assumed operation of the field. The facilities for the field operation of the pilot were refined and implementation was begun. Core flood experiments conducted during the last year were used to help define possible mechanisms involved in microbial enhanced oil recovery. The experiments were performed at SEVVSU temperature using fluids and inoculum from the unit. The model described in last year`s report was further validated using results from a core flood experiment. The model was able to simulate the results of one of the core flood experiments with good quality.

  5. Hypocaloric diet supplemented with probiotic cheese improves body mass index and blood pressure indices of obese hypertensive patients--a randomized double-blind placebo-controlled pilot study.

    Science.gov (United States)

    Sharafedtinov, Khaider K; Plotnikova, Oksana A; Alexeeva, Ravilay I; Sentsova, Tatjana B; Songisepp, Epp; Stsepetova, Jelena; Smidt, Imbi; Mikelsaar, Marika

    2013-10-12

    Gut lactobacilli can affect the metabolic functions of healthy humans. We tested whether a 1500 kcal/d diet supplemented with cheese containing the probiotic Lactobacillus plantarum TENSIA (Deutsche Sammlung für Mikroorganismen, DSM 21380) could reduce some symptoms of metabolic syndrome in Russian adults with obesity and hypertension. In this 3-week, randomized, double-blind, placebo-controlled, parallel pilot study, 25 subjects ingested probiotic cheese and 15 ingested control cheese. Fifty grams of each cheese provided 175 kcal of energy. Blood pressure (BP), anthropometric characteristics, markers of liver and kidney function, metabolic indices (plasma glucose, lipids, and cholesterol), and urine polyamines were measured. Counts of fecal lactobacilli and L. plantarum TENSIA were evaluated using molecular methods. The data were analyzed by t-test for independent samples and Spearman's partial correlation analysis. The probiotic L. plantarum TENSIA was present in variable amounts (529.6 ± 232.5 gene copies) in 16/25 (64%) study subjects. Body mass index (BMI) was significantly reduced (p = 0.031) in the probiotic cheese group versus the control cheese group. The changes in BMI were closely associated with the water content of the body (r = 0.570, p = 0.0007) when adjusted for sex and age. Higher values of intestinal lactobacilli after probiotic cheese consumption were associated with higher BMI (r = 0.383, p = 0.0305) and urinary putrescine content (r = 0.475, p = 0.006). In patients simultaneously treated with BP-lowering drugs, similar reductions of BP were observed in both groups. A positive association was detected between TENSIA colonization and the extent of change of morning diastolic BP (r = 0.617, p = 0.0248) and a trend toward lower values of morning systolic BP (r = -0.527, p = 0.0640) at the end of the study after adjusting for BMI, age, and sex. In a pilot study of obese hypertensive patients, a hypocaloric diet supplemented with a probiotic cheese

  6. Electrically Assisted Movement Therapy in Chronic Stroke Patients With Severe Upper Limb Paresis: A Pilot, Single-Blind, Randomized Crossover Study.

    Science.gov (United States)

    Carda, Stefano; Biasiucci, Andrea; Maesani, Andrea; Ionta, Silvio; Moncharmont, Julien; Clarke, Stephanie; Murray, Micah M; Millán, José Del R

    2017-08-01

    To evaluate the effects of electrically assisted movement therapy (EAMT) in which patients use functional electrical stimulation, modulated by a custom device controlled through the patient's unaffected hand, to produce or assist task-specific upper limb movements, which enables them to engage in intensive goal-oriented training. Randomized, crossover, assessor-blinded, 5-week trial with follow-up at 18 weeks. Rehabilitation university hospital. Patients with chronic, severe stroke (N=11; mean age, 47.9y) more than 6 months poststroke (mean time since event, 46.3mo). Both EAMT and the control intervention (dose-matched, goal-oriented standard care) consisted of 10 sessions of 90 minutes per day, 5 sessions per week, for 2 weeks. After the first 10 sessions, group allocation was crossed over, and patients received a 1-week therapy break before receiving the new treatment. Fugl-Meyer Motor Assessment for the Upper Extremity, Wolf Motor Function Test, spasticity, and 28-item Motor Activity Log. Forty-four individuals were recruited, of whom 11 were eligible and participated. Five patients received the experimental treatment before standard care, and 6 received standard care before the experimental treatment. EAMT produced higher improvements in the Fugl-Meyer scale than standard care (PFugl-Meyer points and 1 Fugl-Meyer point after the experimental treatment and standard care, respectively. The improvement was also significant in subjective reports of quality of movement and amount of use of the affected limb during activities of daily living (P<.05). EAMT produces a clinically important impairment reduction in stroke patients with chronic, severe upper limb paresis. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  7. Efficacy of treatment of insomnia in migraineurs with eszopiclone (Lunesta®) and its effect on total sleep time, headache frequency, and daytime functioning: A randomized, double-blind, placebo-controlled, parallel-group, pilot study.

    Science.gov (United States)

    Spierings, Egilius L H; McAllister, Peter J; Bilchik, Tanya R

    2015-04-01

    A review on headache and insomnia revealed that insomnia is a risk factor for increased headache frequency and headache intensity in migraineurs. The authors designed a randomized, double blind, placebo-controlled, parallel-group, pilot study in which migraineurs who also had insomnia were enrolled, to test this observation. In the study, the authors treated 79 subjects with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia for 6 weeks with 3 mg eszopiclone (Lunesta(®)) or placebo at bedtime. The treatment was preceded by a 2-week baseline period and followed by a 2-week run-out period. Of the 79 subjects treated, 75 were evaluable, 35 in the eszopiclone group, and 40 in the placebo group. At baseline, the groups were comparable except for sleep latency. Of the three remaining sleep variables, total sleep time, nighttime awakenings, and sleep quality, the number of nighttime awakenings during the 6-week treatment period was significantly lower in the eszopiclone group than in the placebo group (P = 0.03). Of the three daytime variables, alertness, fatigue, and functioning, this was also the case for fatigue (P = 005). The headache variables, frequency, duration, and intensity, did not show a difference from placebo during the 6-week treatment period. The study did not meet primary endpoint, that is, the difference in total sleep time during the 6-week treatment period between eszopiclone and placebo was less than 40 minutes. Therefore, it failed to answer the question as to whether insomnia is, indeed, a risk factor for increased headache frequency and headache intensity in migraineurs.

  8. Is pulmonary function affected by bilateral dual transversus abdominis plane block? A randomized, placebo-controlled, double-blind, crossover pilot study in healthy male volunteers

    DEFF Research Database (Denmark)

    Petersen, Maria; Elers, Jimmi; Børglum, Jens

    2011-01-01

    : Transversus abdominis plane (TAP) blocks have been shown to reduce postoperative pain after various abdominal surgical procedures in several studies. The motor nerves of the abdominal wall are located in the same plane as the sensory nerves affected by the TAP block. The aim of this study...

  9. Is pulmonary function affected by bilateral dual transversus abdominis plane block? A randomized, placebo-controlled, double-blind, crossover pilot study in healthy male volunteers

    DEFF Research Database (Denmark)

    Petersen, Maria; Elers, Jimmi; Børglum, Jens

    2011-01-01

    : Transversus abdominis plane (TAP) blocks have been shown to reduce postoperative pain after various abdominal surgical procedures in several studies. The motor nerves of the abdominal wall are located in the same plane as the sensory nerves affected by the TAP block. The aim of this study was t...... was to examine whether the application of an ultrasound-guided TAP block would affect the muscles of the anterior abdominal wall with respect to their function as accessory respiratory muscles and hence pulmonary function....

  10. Evaluating the effects of amantadin, modafinil and acetyl-L-carnitine on fatigue in multiple sclerosis--result of a pilot randomized, blind study.

    Science.gov (United States)

    Ledinek, Alenka Horvat; Sajko, Mojca Cizek; Rot, Uros

    2013-12-01

    Fatigue affects more than 60% of multiple sclerosis (MS) patients and is one of the most troublesome symptoms of the disease. Current treatment options for MS fatigue include amantadine, modafinil and acetyl-l-carnitine (ALCAR). The aim of our study was to compare efficacy of amantadine, modafinil and ALCAR with placebo in patients with MS. Patients with MS and a disability level ≤ 5.5 on the Kurtzke Expanded Disability Status Scale (EDSS) and fatigue were included in the study. Patients were assigned to a one month treatment with either amantadine 200mg, ALCAR 2g, modafinil 200mg or placebo. Efficacy of the treatment was evaluated by using the modified fatigue impact scale (MFIS). Sixty patients were included in the study (39 females). The mean age of patients was 38 ± 6.7 years and the mean disease duration was 6.6 ± 1.2 years. Contrast analysis showed significantly lower mean MFIS score after one month in patients on amantadine compared to placebo (mean difference=17.3, p=0.001). There was also a trend of a lower MFIS score in ALCAR group in comparison to placebo (mean difference=12.4, p=0.05, with Keppel-corrected alpha of 0.046). The quality of life measured as SF 36 - PCS and SF 36 - MCS proved to be significantly influenced by treatment. One month treatment with amantadine improved fatigue in patients with relapsing-remitting MS as evaluated by MFIS. No or only a trend of improvement was seen in patients treated with modafinil or ALCAR, respectively. Copyright © 2013 Elsevier B.V. All rights reserved.

  11. Regular Yoga Practice Improves Antioxidant Status, Immune Function, and Stress Hormone Releases in Young Healthy People: A Randomized, Double-Blind, Controlled Pilot Study.

    Science.gov (United States)

    Lim, Sung-Ah; Cheong, Kwang-Jo

    2015-09-01

    The aim of the present study is to highlight the beneficial effects of yoga practice on bio-parameters, such as oxidative stress, antioxidant components, immune functions, and secretion of stress hormones, in healthy young people. This study was conducted on healthy volunteers recruited from among university students, who were divided into two groups: a control (no yoga intervention, n=13) group and a yoga (n=12) group. Yoga practice was with an instructor for 90 minutes once a week spread over 12 weeks, with recommendations to practice daily at home for 40 minutes with the help of a DVD. The yoga program consisted of yoga body poses (asanas), exercises involving awareness, voluntary regulation of breath (pranayama), and meditational practices. Whole blood samples were collected when the volunteers had fasted for 8 hours at 0 and 12 weeks. The oxidative stress/antioxidant components, immune-related cytokines, and stress hormones were evaluated in serum or plasma. Serum levels of nitric oxide, F2-isoprostane, and lipid peroxide were significantly decreased by yoga practice (pstress and improved antioxidant levels of the body. Moreover, yoga beneficially affected stress hormone releases as well as partially improved immune function.

  12. Effect of acupuncture for radioactive-iodine-induced anorexia in thyroid cancer patients: a randomized, double-blinded, sham-controlled pilot study.

    Science.gov (United States)

    Jeon, Ju-Hyun; Yoon, Jeungwon; Cho, Chong-Kwan; Jung, In-Chul; Kim, Sungchul; Lee, Suk-Hoon; Yoo, Hwa-Seung

    2015-05-01

    The aim of this study is to evaluate the efficacy and safety of acupuncture for radioactive iodine (RAI)-induced anorexia in thyroid cancer patients. Fourteen thyroid cancer patients with RAI-induced anorexia were randomized to a true acupuncture or sham acupuncture group. Both groups were given 6 true or sham acupuncture treatments in 2 weeks. Outcome measures included the change of the Functional Assessment of Anorexia and Cachexia Treatment (FAACT; Anorexia/Cachexia Subscale [ACS], Functional Assessment of Cancer Therapy-General [FACT-G]), Visual Analogue Scale (VAS), weight, body mass index (BMI), ACTH, and cortisol levels. The mean FAACT ACS scores of the true and sham acupuncture groups increased from baseline to exit in intention-to-treat (ITT) and per protocol (PP) analyses; the true acupuncture group showed higher increase but with no statistical significance. Between groups, from baseline to the last treatment, statistically significant differences were found in ITT analysis of the Table of Index (TOI) score (P = .034) and in PP analysis of the TOI (P = .016), FACT-G (P = .045), FAACT (P = .037) scores. There was no significant difference in VAS, weight, BMI, ACTH, and cortisol level changes between groups. Although the current study is based on a small sample of participants, our findings support the safety and potential use of acupuncture for RAI-induced anorexia and quality of life in thyroid cancer patients. © The Author(s) 2015.

  13. Comparison of Treatment Effects and Allergic responses to stiff neck between Sweet Bee Venom and Bee Venom Pharmacopuncture (A pilot study, Double blind, Randomized Controlled Clinical Trail

    Directory of Open Access Journals (Sweden)

    Kyoung-hee Lee

    2008-12-01

    Full Text Available Objective : The purpose of this study is to investigate the difference of treatment effects and allergic responses to stiff neck between Bee Venom Pharmacopuncture and Sweet Bee Venom Pharmacopuncture. Methods : Forty one patients who felt stiff neck were randomly divided into two groups, a Bee Venom Pharmacopuncture group(group Ⅰ and a Sweet Bee Venom Pharmacopuncture group(group Ⅱ. Evaluations of the treatment effects were made before and after a treatment using Visual Analog Scale(VAS, Neck Disability Index(NDI, Clinical Evaluation Grade(CEG. The comparison of allergic responses was measured with VAS. The obtained data were analyzed and compared with SPSS. Results : The group Ⅰ and group Ⅱ showed significant improvement(p<0.05 according to the VAS, NDI, CEG. And the differences between the two groups were insignificant according to VAS, NDI, CEG. But allergic responses such as localized edema, localized itching were significantly lower in group Ⅱ than group Ⅰ. Conclusions : It seems that there are no big different treatment effects between the two groups. Sweet Bee Venom Pharmacopuncture appears to be more effective measurement against allergic reactions than the Bee Venom Pharmacopuncture. Further studies are needed for the comparison of Bee Venom Pharmacopuncture and Sweet Bee Venom Pharmacopuncture.

  14. Double-blind, Placebo-controlled Trial to Evaluate the Effectiveness of Polypodium Leucotomos Extract in the Treatment of Melasma in Asian Skin: A Pilot Study.

    Science.gov (United States)

    Goh, Chee-Leok; Chuah, Sai Yee; Tien, Steven; Thng, Guan; Vitale, María Alejandra; Delgado-Rubin, Arancha

    2018-03-01

    Introduction: Melasma is a common pigmentary disorder with a multifactorial etiology that can hinder its management. The aqueous extract of the fern Polypodium leucotomos (PLE), Fernblock ® (IFC, Madrid, Spain), has demonstrated antioxidant and photoprotective activities and has been used for the treatment of several pigmentary disorders. The aim of this study was to evaluate the efficacy and safety of oral PLE in the treatment of melasma in Asian patients. Methods: Forty healthy adult patients with clinical diagnoses of melasma who were receiving treatment with topical 4% hydroquinone cream and sunscreen with a sun protection factor (SPF) of 50+ were recruited for inclusion in this study from the National Skin Centre in Singapore. They were randomized to receive either oral PLE supplementation or placebo for 12 weeks. Patients were assessed at baseline, Day 28, Day 56, and Day 84 using the modified Melasma Area and Severity Index (mMASI); melanin and erythema indexes; VISIA ® photography (Canfield Scientific, Parsippany, New Jersey, USA); and the Melasma Quality of Life (MelasQoL) questionnaire. Adverse events were recorded. Results: Following four, eight, and 12 weeks of treatment, there were statistically significant differences between the mMASI scores of both groups as compared with the baseline scores ( p ≤0.01). mMASI scores of the PLE group at eight and 12 weeks were also significantly lower than those of the placebo group ( p ≤0.05). At the end of the study, a significant improvement was reached in both groups (both p ≤0.01), with no significant differences between them. The scores of the melanin and erythema indices displayed a slight improvement in both groups, without significant differences among them. MelasQoL score showed an improvement in the PLE group versus the placebo group. Our results demonstrate that the PLE aqueous extract product significantly improves and accelerates the outcome reached with hydroquinone and sunscreen almost from

  15. Comparison of Prophylactic Intravenous Magnesium Sulfate with Tramadol for Postspinal Shivering in Elective Cesarean Section: A Placebo Controlled Randomized Double-blind Pilot Study

    Science.gov (United States)

    Sachidananda, Roopa; Basavaraj, K.; Shaikh, Safiya I.; Umesh, G.; Bhat, Triveni; Arpitha, B.

    2018-01-01

    Background and Aims: Cesarean sections are performed mostly under spinal anesthesia. Shivering is one of the distressing complications. The aim of the study was to compare the efficacy of intravenous (i.v) magnesium sulfate and tramadol with placebo (normal saline) on postspinal shivering in elective cesarean section when used as prophylaxis. Methods: One hundred and thirty-five pregnant women between 18 and 35 years age, belonging to the American Society of Anesthesiologists’ physical Status II, undergoing elective cesarean section under spinal anesthesia were enrolled into the study. Patients belonging to Group C (control group, n = 45) received isotonic saline 100 mL i.v, Group T (tramadol group, n = 45) received tramadol 0.5 mg/kg in 100 mL isotonic saline i.v, whereas those in Group M (magnesium sulfate group, n = 45) received magnesium sulfate 30 mg/kg in 100 mL isotonic saline i.v after administering spinal anesthesia. Incidence and grades of shivering were noted. Data were analyzed using one-way ANOVA test and Chi-square test. Results: The incidence of shivering in Group C, Group T, and Group M were 67.5%, 43.9%, and 39%, respectively. The incidence of shivering in Group M and Group T was significantly low when compared to Group C (P = 0.008; P = 0.026), whereas there was no statistically significant difference between Groups T and M (P = 0.654). Conclusion: Magnesium sulfate and tramadol significantly reduce the incidence of shivering compared to placebo when used as prophylaxis in pregnant women undergoing cesarean section under spinal anesthesia. Magnesium sulfate reduces the severity of the shivering.

  16. Effect of BCAA supplement timing on exercise-induced muscle soreness and damage: a pilot placebo-controlled double-blind study.

    Science.gov (United States)

    Ra, Song-Gyu; Miyazaki, Teruo; Kojima, Ryo; Komine, Shoichi; Ishikura, Keisuke; Kawanaka, Kentaro; Honda, Akira; Matsuzaki, Yasushi; Ohmori, Hajime

    2017-09-22

    The aim of present study was to compare the effects of branched-chain amino acid (BCAA) supplementation taken before or after exercise on delayed onset muscle soreness (DOMS) and exercise-induced muscle damage (EIMD). Fifteen young men (aged 21.5 ± 0.4 years) were given either BCAA (9.6 g·day-1) or placebo before and after exercise (and for 3 days prior to and following the exercise day) in three independent groups: the Control group (placebo before and after exercise), the PRE group (BCAA before exercise and placebo after exercise), and the POST group (placebo before exercise and BCAA after exercise). Participants performed 30 repetitions of eccentric exercise with the non-dominant arm. DOMS, upper arm circumference (CIR), elbow range of motion (ROM), serum creatine kinase (CK), lactate dehydrogenase (LDH), and aldolase, BCAA, and Beta-hydroxy-Beta-methylbutyrate (3HMB) were measured immediately before and after the exercise and on the following 4 days. Serum BCAA and 3HMB concentrations increased significantly in the PRE group immediately after the exercise, recovering to baseline over the following days. In the days following the exercise day, DOMS, CIR, and ROM were significantly improved in the PRE group compared to the Control group, with weaker effects in the POST group. Serum activities of CK, LDH, and aldolase in the days following the exercise day were significantly suppressed in the PRE group compared to Control group. Present study confirmed that repeated BCAA supplementation before exercise had a more beneficial effect in attenuating DOMS and EIMD induced by eccentric exercise than repeated supplementation after exercise.

  17. Comparison of Dry Needling versus Orthopedic Manual Therapy in Patients with Myofascial Chronic Neck Pain: A Single-Blind, Randomized Pilot Study

    Science.gov (United States)

    Campa-Moran, Irene; Rey-Gudin, Etelvina; Fernández-Carnero, Josué; Paris-Alemany, Alba; Gil-Martinez, Alfonso; Lerma Lara, Sergio; Prieto-Baquero, Almudena; Alonso-Perez, José Luis; La Touche, Roy

    2015-01-01

    Objective. The aim of this study was to compare the efficacy of three interventions for the treatment of myofascial chronic neck pain. Methods. Thirty-six patients were randomly assigned to one of three intervention groups: orthopedic manual therapy (OMT), dry needling and stretching (DN-S), and soft tissue techniques (STT). All groups received two treatment sessions with a 48 h time interval. Outcome measures included neck pain intensity measured using a visual analogue scale, cervical range of motion (ROM), pressure pain threshold for measuring mechanical hyperalgesia, and two self-reported questionnaires (neck disability index and pain catastrophizing scale). Results. The ANOVA revealed significant differences for the group × time interaction for neck disability, neck pain intensity, and pain catastrophizing. The DN-S and OMT groups reduced neck disability. Only the OMT group showed decreases in mechanical hyperalgesia and pain catastrophizing. The cervical ROM increased in OMT (i.e., flexion, side-bending, and rotation) and DN-S (i.e., side-bending and rotation) groups. Conclusions. The three interventions are all effective in reducing pain intensity. Reduction in mechanical hyperalgesia and pain catastrophizing was only observed in the OMT group. Cervical ROM improved in the DN-S and OMT groups and also neck disability being only clinically relevant for OMT group. PMID:26640708

  18. Comparison of Dry Needling versus Orthopedic Manual Therapy in Patients with Myofascial Chronic Neck Pain: A Single-Blind, Randomized Pilot Study

    Directory of Open Access Journals (Sweden)

    Irene Campa-Moran

    2015-01-01

    Full Text Available Objective. The aim of this study was to compare the efficacy of three interventions for the treatment of myofascial chronic neck pain. Methods. Thirty-six patients were randomly assigned to one of three intervention groups: orthopedic manual therapy (OMT, dry needling and stretching (DN-S, and soft tissue techniques (STT. All groups received two treatment sessions with a 48 h time interval. Outcome measures included neck pain intensity measured using a visual analogue scale, cervical range of motion (ROM, pressure pain threshold for measuring mechanical hyperalgesia, and two self-reported questionnaires (neck disability index and pain catastrophizing scale. Results. The ANOVA revealed significant differences for the group × time interaction for neck disability, neck pain intensity, and pain catastrophizing. The DN-S and OMT groups reduced neck disability. Only the OMT group showed decreases in mechanical hyperalgesia and pain catastrophizing. The cervical ROM increased in OMT (i.e., flexion, side-bending, and rotation and DN-S (i.e., side-bending and rotation groups. Conclusions. The three interventions are all effective in reducing pain intensity. Reduction in mechanical hyperalgesia and pain catastrophizing was only observed in the OMT group. Cervical ROM improved in the DN-S and OMT groups and also neck disability being only clinically relevant for OMT group.

  19. A Randomized, Double-blind, Placebo-controlled, Parallel-group, Pilot Study of Cannabidiol-rich Botanical Extract in the Symptomatic Treatment of Ulcerative Colitis.

    Science.gov (United States)

    Irving, Peter M; Iqbal, Tariq; Nwokolo, Chuka; Subramanian, Sreedhar; Bloom, Stuart; Prasad, Neeraj; Hart, Ailsa; Murray, Charles; Lindsay, James O; Taylor, Adam; Barron, Rachel; Wright, Stephen

    2018-03-19

    Cannabidiol (CBD) exhibits anti-inflammatory properties that could improve disease activity in inflammatory bowel disease. This proof-of-concept study assessed efficacy, safety and tolerability of CBD-rich botanical extract in ulcerative colitis (UC) patients. Patients aged 18 years or older, with left-sided or extensive UC, Mayo scores of 4-10 (endoscopy scores ≥1), and on stable 5-aminosalicylic acid dosing, were randomized to 10-weeks' CBD-rich botanical extract or placebo capsules. The primary endpoint was the percentage of patients in remission after treatment. Statistical testing was 2-sided, using a 10% significance level. Patients were less tolerant of CBD-rich botanical extract compared with placebo, taking on average one-third fewer capsules, and having more compliance-related protocol deviations (principally insufficient exposure), prompting identification of a per protocol (PP) analysis set. The primary endpoint was negative; end of treatment remission rates were similar for CBD-rich botanical extract (28%) and placebo (26%). However, PP analysis of total and partial Mayo scores favoured CBD-rich botanical extract (P = 0.068 and P = 0.038, respectively). Additionally, PP analyses of the more subjective physician's global assessment of illness severity, subject global impression of change, and patient-reported quality-of-life outcomes were improved for patients taking CBD-rich botanical extract (P = 0.069, P = 0.003, and P = 0.065, respectively). Adverse events (AEs) were predominantly mild/moderate with many in the CBD-rich botanical extract group potentially attributable to the ∆9-tetrahydrocannabinol content. A greater proportion of gastrointestinal-related AEs, indicative of UC worsening, was seen on placebo. Although the primary endpoint was not reached, several signals suggest CBD-rich botanical extract may be beneficial for symptomatic treatment of UC.

  20. Blindness

    Science.gov (United States)

    ... Specific Prevalence Rates for Blindness by Age and Race/Ethnicity Table for 2010 U.S. Age-Specific Prevalence ... Race/Ethnicity 2010 Prevalence Rates of Blindness by Race Table for 2010 Prevalence Rates of Blindness by ...

  1. 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.

  2. Clinical effects of buspirone in social phobia : A double-blind placebo-controlled study

    NARCIS (Netherlands)

    denBoer, JA; Westenberg, HGM; Pian, KLH

    Background: The results of open pilot studies suggest that the serotonin-1A (5-HT1A) receptor agonist buspirone might be effective in social phobia. Method: In the present study, the efficacy of buspirone was investigated in patients with social phobia using a 12-week double-blind placebo-controlled

  3. 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.

  4. Conducting pilot and feasibility studies.

    Science.gov (United States)

    Cope, Diane G

    2015-03-01

    Planning a well-designed research study can be tedious and laborious work. However, this process is critical and ultimately can produce valid, reliable study findings. Designing a large-scale randomized, controlled trial (RCT)-the gold standard in quantitative research-can be even more challenging. Even the most well-planned study potentially can result in issues with research procedures and design, such as recruitment, retention, or methodology. One strategy that may facilitate sound study design is the completion of a pilot or feasibility study prior to the initiation of a larger-scale trial. This article will discuss pilot and feasibility studies, their advantages and disadvantages, and implications for oncology nursing research. 
.

  5. Effect of the glucagon-like peptide-1 analogue liraglutide on coronary microvascular function in patients with type 2 diabetes – a randomized, single-blinded, cross-over pilot study

    DEFF Research Database (Denmark)

    Faber, Rebekka; Zander, Mette; Pena, Adam

    2015-01-01

    with either the GLP-1 analogue liraglutide or received no treatment for 10 weeks, in a randomized, single-blinded, cross-over setup with a 2 weeks wash-out period. The effect of liraglutide on coronary microcirculation was evaluated using non-invasive trans-thoracic Doppler-flow echocardiography during...... dipyridamole induced stress. Peripheral microvascular endothelial function was assessed by Endo-PAT2000®. Interventions were compared by two-sample t-test after ensuring no carry over effect. RESULTS: A total of 24 patients were included. Twenty patients completed the study (15 male; mean age 57 ± 9; mean BMI...

  6. Blindness

    Science.gov (United States)

    ... doctors may do surgery to remove it. Is Learning Different? A baby who is blind can still ... do amazing things in many different fields, including music, the arts, and even sports. Serious vision problems ...

  7. Speech Alarms Pilot Study

    Science.gov (United States)

    Sandor, A.; Moses, H. R.

    2016-01-01

    Currently on the International Space Station (ISS) and other space vehicles Caution & Warning (C&W) alerts are represented with various auditory tones that correspond to the type of event. This system relies on the crew's ability to remember what each tone represents in a high stress, high workload environment when responding to the alert. Furthermore, crew receive a year or more in advance of the mission that makes remembering the semantic meaning of the alerts more difficult. The current system works for missions conducted close to Earth where ground operators can assist as needed. On long duration missions, however, they will need to work off-nominal events autonomously. There is evidence that speech alarms may be easier and faster to recognize, especially during an off-nominal event. The Information Presentation Directed Research Project (FY07-FY09) funded by the Human Research Program included several studies investigating C&W alerts. The studies evaluated tone alerts currently in use with NASA flight deck displays along with candidate speech alerts. A follow-on study used four types of speech alerts to investigate how quickly various types of auditory alerts with and without a speech component - either at the beginning or at the end of the tone - can be identified. Even though crew were familiar with the tone alert from training or direct mission experience, alerts starting with a speech component were identified faster than alerts starting with a tone. The current study replicated the results from the previous study in a more rigorous experimental design to determine if the candidate speech alarms are ready for transition to operations or if more research is needed. Four types of alarms (caution, warning, fire, and depressurization) were presented to participants in both tone and speech formats in laboratory settings and later in the Human Exploration Research Analog (HERA). In the laboratory study, the alerts were presented by software and participants were

  8. Speech Alarms Pilot Study

    Science.gov (United States)

    Sandor, Aniko; Moses, Haifa

    2016-01-01

    Speech alarms have been used extensively in aviation and included in International Building Codes (IBC) and National Fire Protection Association's (NFPA) Life Safety Code. However, they have not been implemented on space vehicles. Previous studies conducted at NASA JSC showed that speech alarms lead to faster identification and higher accuracy. This research evaluated updated speech and tone alerts in a laboratory environment and in the Human Exploration Research Analog (HERA) in a realistic setup.

  9. 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.

  10. Preoperative therapeutic programme for elderly patients scheduled for elective abdominal oncological surgery: A randomized controlled pilot study

    NARCIS (Netherlands)

    Dronkers, J.J.; Lamberts, H.; Reutelingsperger, I.M.M.D.; Naber, R.H.; Dronkers-Landman, C.M.; Veldman, A.; Meeteren, N.L.U. van

    2010-01-01

    Objective: Investigation of the feasibility and preliminary effect of a short-term intensive preoperative exercise programme for elderly patients scheduled for elective abdominal oncological surgery. Design: Single-blind randomized controlled pilot study. Setting: Ordinary hospital in the

  11. Self-Actualization of Elite Blind Athletes: An Exploratory Study.

    Science.gov (United States)

    Sherrill, C.; And Others

    1990-01-01

    This study used the Personal Orientation Inventory to compare self-actualization of 52 elite blind athletes with sighted athletes. Self-actualization profiles of blind athletes were lower for measures of existentiality and self-acceptance but otherwise identical to those of sighted athletes. Both sighted and blind athletes scored below test-manual…

  12. A Single-blind, Split-face, Randomized, Pilot Study Comparing the Effects of Intradermal and Intramuscular Injection of Two Commercially Available Botulinum Toxin A Formulas to Reduce Signs of Facial Aging

    Science.gov (United States)

    Sapra, Priya; Sapra, Sheetal; Khanna, Julie; Mraud, Kelli; Bonadonna, Jennifer

    2017-01-01

    Objective: To examine the effectiveness of intradermal botulinum toxin type A injection in improving skin texture and midface lift while reducing pore size and sebum production, as well as investigate the differences in effectiveness between onabotulinumtoxinA and abobotulinumtoxinA using intradermal and intramuscular injection methods. Design: A 16-week, single-blind, split-face, randomized study. Each patient served as their own control, receiving onabotulinumtoxinA and abobotulinumtoxinA randomized to either the left or right side of the face. Patients received intradermal botulinum toxin type A injections at Week 0 and intramuscular botulinum toxin type A injections at Week 2. Participants: Ten women aged 35 to 65 years who exhibited static rhytids in the glabellar and periorbital area. Measurements: The primary endpoint was efficacy of split-face treatment of intradermal and intramuscular onabotulinumtoxinA and abobotulinumtoxinA as assessed by a blinded evaluator using baseline and post-treatment photographs. The secondary endpoints included safety as assessed by adverse events and patient satisfaction measured by questionnaires completed at baseline and post-treatment. Results: Intradermal injection of botulinum toxin type A led to a statistically significant improvement in skin texture (p=0.004) while also resulting in mild midface lift (p=0.024), but did not provide a significant reduction of pore size and sebum production. There was no statistically significant difference between onabotulinumtoxinA and abobotulinumtoxinA when injected intradermally or intramuscularly. Conclusion: Intradermal injection of botulinum toxin type A appears to be a safe and effective therapy that provides an improvement in facial skin texture and midface lift. Registry: clinicaltrials.gov (ID#: NCT02907268). PMID:28367260

  13. 90% Compliance Pilot Studies Final Report

    Energy Technology Data Exchange (ETDEWEB)

    None

    2013-06-01

    In early 2010, the U.S. Department of Energy (DOE) announced an opportunity for states to participate in energy code compliance evaluation pilot studies. DOE worked with five Regional Energy Efficiency Organizations (REEOs, formerly referred to as Energy Efficiency Partnerships, or EEPs) to fund pilot studies covering nine states. This report details conclusions stated in individual state reports, as well as conclusions drawn by DOE based on their oversight of the pilot studies, and based on discussions held with the REEOs and representatives from the pilot study states and their contractors.

  14. Acupuncture with non-steroidal anti-inflammatory drugs (NSAIDs) versus acupuncture or NSAIDs alone for the treatment of chronic neck pain: an assessor-blinded randomised controlled pilot study.

    Science.gov (United States)

    Cho, Jae-Heung; Nam, Dong-Hyun; Kim, Ki-Tack; Lee, Jun-Hwan

    2014-02-01

    To investigate the feasibility and sample size required for a full-scale randomised controlled trial of the effectiveness of acupuncture with non-steroidal anti-inflammatory drugs (NSAIDs) for chronic neck pain compared with acupuncture or NSAID treatment alone. A total of 45 patients with chronic neck pain participated in the study. For 3 weeks the acupuncture with NSAIDs treatment group took NSAIDs (zaltoprofen, 80 mg) daily while receiving acupuncture treatment three times a week. The acupuncture treatment group received treatment three times a week and the NSAID treatment group took NSAIDs daily. The primary outcomes were to determine the feasibility and to calculate the sample size. As secondary outcomes, pain intensity and pain-related symptoms for chronic neck pain were measured. With regard to enrolment and dropout rates, 88.2% of patients consented to be recruited to the trial and 15.6% of participants were lost to follow-up. The sample size for a full-scale trial was estimated to be 120 patients. Although preliminary, there was a significant change in the visual analogue scale (VAS) for neck pain intensity between the baseline measurement and each point of assessment in all groups. However, there was no difference in VAS scores between the three groups. This pilot study has provided the feasibility and sample size for a full-scale trial of acupuncture with NSAIDs for chronic neck pain compared with acupuncture or NSAID treatment alone. Further research is needed to validate the effects of acupuncture with NSAIDs.

  15. Classroom acoustics: Three pilot studies

    Science.gov (United States)

    Smaldino, Joseph J.

    2005-04-01

    This paper summarizes three related pilot projects designed to focus on the possible effects of classroom acoustics on fine auditory discrimination as it relates to language acquisition, especially English as a second language. The first study investigated the influence of improving the signal-to-noise ratio on the differentiation of English phonemes. The results showed better differentiation with better signal-to-noise ratio. The second studied speech perception in noise by young adults for whom English was a second language. The outcome indicated that the second language learners required a better signal-to-noise ratio to perform equally to the native language participants. The last study surveyed the acoustic conditions of preschool and day care classrooms, wherein first and second language learning occurs. The survey suggested an unfavorable acoustic environment for language learning.

  16. Effects of a hops (Humulus lupulus L.) dry extract supplement on self-reported depression, anxiety and stress levels in apparently healthy young adults: a randomized, placebo-controlled, double-blind, crossover pilot study.

    Science.gov (United States)

    Kyrou, Ioannis; Christou, Aimilia; Panagiotakos, Demosthenes; Stefanaki, Charikleia; Skenderi, Katerina; Katsana, Konstantina; Tsigos, Constantine

    2017-04-01

    The Humulus lupulus L. plant (hops) is used as a herbal medicinal product for anxiety/mood disorders. Our aim was to study the effects of a hops dry extract on self-reported depression, anxiety and stress levels in young adults. Apparently healthy young adults from our university completed the Depression Anxiety Stress Scale-21 (DASS-21) and those reporting at least mild depression, anxiety and stress were invited to complete the study intervention. This followed a randomized (1:1), placebo-controlled, double-blind, crossover design with two 4-week intervention periods (hops or placebo; two 0.2 gr capsules once daily) separated by a 2-week wash-out. Anthropometric measurements, DASS-21 assessments and measurements of morning cortisol plasma levels were performed at the beginning and the end of the 4-week treatment periods. 36 participants (Females/Males: 31/5; age: 24.7±0.5 years) completed the study intervention (attrition: 6/42). No significant changes in body weight and composition or morning circulating cortisol were noted with the hops or placebo. Significantly decreased DASS-21 anxiety, depression and stress scores were documented with hops (9.2±7.3 vs. 5.1±5.9, 11.9±7.9 vs. 9.2±7.4, and 19.1±8.1 vs. 11.6±8.1; all p values hops dry extract can significantly improve all these symptoms over a 4-week period. These beneficial effects agree with the indication of hops for anxiety/mood disorders and restlessness, as approved by the German Commission E.

  17. A pilot study to determine whether external stabilisation of the chest ...

    African Journals Online (AJOL)

    Objectives. This was a pilot study to determine whether external stabilisation of the chest wall with a splint reduces the need for mechanical ventilation in preterm infants, within the first 7 days after study entry. Design. This was a non-blinded prospective randomised controlled study. After consent was obtained, babies were ...

  18. A randomised controlled cross-over double-blind pilot study protocol on THC:CBD oromucosal spray efficacy as an add-on therapy for post-stroke spasticity.

    Science.gov (United States)

    Marinelli, Lucio; Balestrino, Maurizio; Mori, Laura; Puce, Luca; Rosa, Gian Marco; Giorello, Laura; Currà, Antonio; Fattapposta, Francesco; Serrati, Carlo; Gandolfo, Carlo; Abbruzzese, Giovanni; Trompetto, Carlo

    2017-09-07

    Stroke is the most disabling neurological disorder and often causes spasticity. Transmucosal cannabinoids (tetrahydrocannabinol and cannabidiol (THC:CBD), Sativex) is currently available to treat spasticity-associated symptoms in patients with multiple sclerosis. Cannabinoids are being considered useful also in the treatment of pain, nausea and epilepsy, but may bear and increased risk for cardiovascular events. Spasticity is often assessed with subjective and clinical rating scales, which are unable to measure the increased excitability of the monosynaptic reflex, considered the hallmark of spasticity. The neurophysiological assessment of the stretch reflex provides a precise and objective method to measure spasticity. We propose a novel study to understand if Sativex could be useful in reducing spasticity in stroke survivors and investigating tolerability and safety by accurate cardiovascular monitoring. We will recruit 50 patients with spasticity following stroke to take THC:CBD in a double-blind placebo-controlled cross-over study. Spasticity will be assessed with a numeric rating scale for spasticity, the modified Ashworth scale and with the electromyographical recording of the stretch reflex. The cardiovascular risk will be assessed prior to inclusion. Blood pressure, heart rate, number of daily spasms, bladder function, sleep disruption and adverse events will be monitored throughout the study. A mixed-model analysis of variance will be used to compare the stretch reflex amplitude between the time points; semiquantitative measures will be compared using the Mann-Whitney test (THC:CBD vs placebo) and Wilcoxon test (baseline vs treatment). The study was registered on the EudraCT database with number 2016-001034-10 and approved by both the Italian Medicines Agency (Agenzia Italiana del Farmaco) and local Ethics Committee 'Comitato Etico Regionale della Liguria'. Data will be made anonymous and uploaded to a open access repository. Results will be disseminated

  19. Liverpool Telecare Pilot: case studies

    Directory of Open Access Journals (Sweden)

    Nigel Barnes

    2006-09-01

    Full Text Available Telecare services use information and communications technology (ICT to support the provision of care to people in their own homes. This paper describes a pilot telecare service employed by Liverpool (UK City Council to support a sample of their frail and elderly social services users. The pilot has been running for over two years and has been deployed for 21 individuals in Liverpool. In this paper we present the pilot system and provide real example cases which help to illustrate the benefits of such a system.

  20. A Randomized, Double-Blind, Crossover Pilot Trial of Rice Endosperm Protein Supplementation in Maintenance Hemodialysis Patients.

    Science.gov (United States)

    Hosojima, Michihiro; Shimada, Hisaki; Obi, Yoshitsugu; Kuwahara, Shoji; Kaseda, Ryohei; Kabasawa, Hideyuki; Kondo, Hazuki; Fujii, Mikio; Watanabe, Reiko; Suzuki, Yoshiki; Kadowaki, Motoni; Miyazaki, Shigeru; Saito, Akihiko

    2017-12-21

    In maintenance hemodialysis (MHD) patients, low protein intake is associated with protein-energy wasting, a risk factor that affects outcome. However, increased protein intake may lead to hyperphosphatemia and hyperkalemia, which are also mortality risk factors. Here, we evaluated the safety and effects of purified rice endosperm protein (REP), which contains less phosphorus and potassium than soy and casein proteins, as a supplemental protein source for MHD patients. This randomized, double-blind, placebo-controlled, crossover pilot study of REP supplementation (5 g/day × 4 weeks) was carried out in 50 Japanese adult MHD patients (1 dropped out); the primary outcome was the change in the urea kinetic-based normalized protein catabolic rate (nPCR), an indicator of protein intake in MHD patients. Intention-to-treat analyses of 24 patients in the REP-first group and 25 in the placebo-first group showed that REP supplementation increased nPCR significantly by 0.07 g/kg/day (95% confidence interval, 0.03-0.11), whereas changes in serum phosphorus and potassium concentrations were not different from the placebo. REP supplementation did not show a significant effect on other nutritional or metabolic parameters and no specific complications. In conclusion, purified REP with efficient bioavailability may be safe and useful for dietary supplementation in MHD patients.

  1. Dexamethasone for Dyspnea in Cancer Patients: A Pilot Double-Blind, Randomized, Controlled Trial

    Science.gov (United States)

    Hui, David; Kilgore, Kelly; Frisbee-Hume, Susan; Park, Minjeong; Tsao, Anne; Guay, Marvin Delgado; Lu, Charles; William, William; Pisters, Katherine; Eapen, George; Fossella, Frank; Amin, Sapna; Bruera, Eduardo

    2016-01-01

    Context Dexamethasone is often used to treat dyspnea in cancer patients but evidence is lacking. Objectives We determined the feasibility of conducting a randomized trial of dexamethasone in cancer patients, and estimated the efficacy of dexamethasone in the treatment of dyspnea. Methods In this double-blind, randomized, controlled trial, patients with dyspnea ≥4 were randomized to receive either dexamethasone 8 mg twice daily × four days then 4 mg twice daily × three days or placebo for seven days, followed by an open-label phase for seven days. We documented the changes in dyspnea (0-10 numeric rating scale [NRS]), spirometry measures, quality of life and toxicities. Results A total of 41 patients were randomized and 35 (85%) completed the blinded phase. Dexamethasone was associated with a significant reduction in dyspnea NRS of -1.9 (95% confidence interval [CI] -3.3 to -0.5, P=0.01) by day 4 and -1.8 (95% CI -3.2 to -0.3, P=0.02) by day 7. In contrast, placebo was associated with a reduction of -0.7 (95% CI -2.1 to 0.6, P=0.38) by day 4 and -1.3 (95% CI -2.4 to -0.2, P=0.03) by day 7. The between-arm difference was not statistically significant. Drowsiness improved with dexamethasone. Dexamethasone was well tolerated with no significant toxicities. Conclusion A double-blind, randomized, controlled trial of dexamethasone was feasible with a low attrition rate. Our preliminary data suggest that dexamethasone may be associated with rapid improvement in dyspnea and was well tolerated. Further studies are needed to confirm our findings. PMID:27330023

  2. BIMOMASS GASIFICATION PILOT PLANT STUDY

    Science.gov (United States)

    The report gives results of a gasification pilot program using two biomass feedstocks: bagasse pellets and wood chips. he object of the program was to determine the properties of biomass product gas and its suitability as a fuel for gas-turbine-based power generation cycles. he f...

  3. Causes of childhood blindness in Malaysia: results from a national study of blind school students.

    Science.gov (United States)

    Reddy, S C; Tan, B C

    2001-01-01

    A national study was conducted in children attending six schools for the blind in Malaysia to identify the anatomical site and underlying causes of blindness (BL) and severe visual impairment (SVI), with a view to determine the potentially preventable and treatable causes so that appropriate control measures can be implemented in the future. The standardized clinical examination of eyes was performed and the findings were recorded on the WHO Prevention of Blindness Programme eye examination record form for children with blindness and low vision. A total of 358 children aged between 7 and 17 years were examined, of whom 332 (92.7%) were blind or severely visually impaired. The results relate to these 332 children. Lens was the major anatomical site (22.3%) of visual loss followed by retina (20.8%), whole globe (17.2%), cornea (15.1%), optic nerve (8.7%) and uvea (5.1%). Glaucoma was responsible for BL/SVI in 7.2% and others in 3.6% of cases. Hereditary diseases were responsible for visual loss in 29.5%, intrauterine factors in 4.5%, perinatal factors in 9% and childhood factors in 7.8% of cases. However, the aetiology was unknown in 49.1% of cases which included congenital anomalies of the globe. Childhood cataract and corneal scarring are major treatable causes of BL/SVI that can benefit from future intervention strategies. Perinatal screening for intrauterine factors and hereditary eye diseases, and appropriate interventional therapy will help in reducing the prevalence of childhood blindness.

  4. High dose vitamin D administration in ventilated intensive care unit patients: A pilot double blind randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jenny E. Han

    2016-06-01

    Conclusions: In this pilot study, high-dose vitamin D3 safely increased plasma 25(OHD concentrations into the sufficient range and was associated with decreased hospital length of stay without altering other clinical outcomes.

  5. Fusion pilot plant scoping study

    International Nuclear Information System (INIS)

    Gierszewski, P.J.; Blevins, P.J.; Brunnader, H.; Natalizio, A.; Cumyn, P.; Dean, B.; Smith, S.; Galambos, J.; Holloway, C.; Stremlaw, J.; Williams, G.

    1994-05-01

    CFFTP Pilot is representative of a class of machines that, like NPD in the CANDU development program, could test the key reactor core technologies on an integrated power reactor relevant system (materials, conditions, configuration). But in order to reduce costs, the machine would operate at reduced neutron flux relative to a power reactor, would not produce electricity, and would not test superconducting magnets. This design shows research directions towards a machine that could provide integrated nuclear testing (but not ignition physics) at a cost of about 1/3 ITER CDA. The test volume - the outboard blanket volume - would be comparable to the test port volume on ITER CDA, while the fluence and power density would be about 1/4 ITER CDA. 91 refs., 43 tabs., 45 figs

  6. APMP Pilot Study on Transmittance Haze

    Science.gov (United States)

    Liu, Wen-Chun; Hwang, Jisoo; Koo, Annette; Wu, Houping; Leecharoen, Rojana; Yu, Hsueh-Ling

    2018-02-01

    Five NMIs within APMP, including CMS/ITRI, MSL, NIM, NIMT and KRISS from TCPR applied to the APMP technical committee initiative project for funding to carry out a pilot comparison of transmittance haze in 2012. The project started in 2014 and the final report was completed at the end of 2016. In this pilot comparison, three different haze standards were adopted, and transmittance haze for each standard was measured according to ASTM D1003 or ISO 14782. This paper presents the first results of an APMP pilot study of transmittance haze and the analysis of the variation among different haze measurement systems which are commonly used. The study shows that the variables such as sphere multiplier, transmittance distribution, fluorescence of samples and optical path of the incident beam cause discrepancies among NMIs and highlight deficiencies in current documentary standards.

  7. Ultrasound to stimulate early bone formation in a distraction gap : a double blind randomised clinical pilot trial in the edentulous mandible

    NARCIS (Netherlands)

    Schortinghuis, J; Bronckers, ALLJ; Stegenga, B; Raghoebar, GM; de Bont, LGM

    Objective: In a double blind randomised clinical pilot trial, it was investigated whether tow intensity pulsed ultrasound therapy stimulates early bone formation in a distraction gap created in a severely resorbed mandible. Design: Eight patients underwent a mandibular vertical distraction over an

  8. In Vitro and in vivo antioxidant and anti-inflammatory capacities of an antioxidant-rich fruit and berry juice blend. Results of a pilot and randomized, double-blinded, placebo-controlled, crossover study

    Science.gov (United States)

    This study investigated the in vitro and in vivo antioxidant and anti-inflammatory properties of a juice blend (JB), MonaVie Active, containing a mixture of fruits and berries with known antioxidant activity, including acai, a palm fruit, as the predominant ingredient. The phytochemical antioxidants...

  9. The effectiveness of moxibustion for the treatment of functional constipation: a randomized, sham-controlled, patient blinded, pilot clinical trial

    Directory of Open Access Journals (Sweden)

    Park Ji-Eun

    2011-12-01

    Full Text Available Abstract Background Moxibustion is an ancient traditional medicine using burning mugworts to stimulate acupuncture points. The aim of this study was to investigate the safety and efficacy of moxibustion for the treatment of constipation using a randomized, sham-controlled, participant-blinded, pilot trial. Methods Twenty-six participants (identified with either qi (vital energy deficiency or qi excess syndrome were randomly divided into either a moxibustion or sham group. Participants were treated with real or sham moxibustion at 4 acupuncture points, ST23 and ST27, bilaterally, 3 times per week for four weeks. The primary outcome was the frequency of defecations; secondary outcomes were the Bristol stool form scale (BSS and the constipation assessment scale (CAS. Results Of the 26 participants that were randomized, 24 completed the study. Defecation frequency, BSS, and CAS showed no difference between the moxibustion and sham groups. The differences were -0.25 (95% CI: -2.08, 1.58, p = 0.78, -1.22 (95% CI: -2.7, 0.26, p = 0.1, 0.91 (95% CI: -1.46, 3.28, p = 0.44 in defecation frequency, BSS, CAS, respectively. The defecation frequency increased from an average of 3.3 to 4.6 times per week in the moxibustion group (1.5[-0.5, 2], p = 0.06 and from 2.7 to 3.7 stools per week in the sham group (1[-1, 2], p = 0.15 after four weeks of treatment. The difference between participants with a deficiency or an excess syndrome, determined based on assessment of sweat, facial features, pain, body energy, and pulse type, was significant in only defecation frequency. The difference was 3.3 (95% CI: 0.41, 6.19, p = 0.03. Conclusion Moxibustion treatment appears safe, but showed no positive effect on constipation. The effectiveness of moxibustion treatment may depend on the syndrome pattern, and further long-term studies with a larger number of subjects are warranted. Trial registration Clinical Research Information Service, KCT0000168

  10. Reiki therapy for postoperative oral pain in pediatric patients: pilot data from a double-blind, randomized clinical trial.

    Science.gov (United States)

    Kundu, Anjana; Lin, Yuting; Oron, Assaf P; Doorenbos, Ardith Z

    2014-02-01

    To examine the effects of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. This was a double-blind, randomized controlled study of children undergoing dental procedures. Participants were randomly assigned to receive either Reiki therapy or the control therapy (sham Reiki) preoperatively. Postoperative pain scores, opioid requirements, and side effects were assessed. Family members were also asked about perioperative care satisfaction. Multiple linear regressions were used for analysis. Thirty-eight children participated. The blinding procedure was successful. No statistically significant difference was observed between groups on all outcome measures. Our study provides a successful example of a blinding procedure for Reiki therapy among children in the perioperative period. This study does not support the effectiveness of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. Copyright © 2013 Elsevier Ltd. All rights reserved.

  11. Sensory Barrage Stimulation in the Treatment of Elbow Spasticity: A Crossover Double Blind Randomized Pilot Trial.

    Science.gov (United States)

    Slovak, Martin; Chindo, Joseph; Nair, Krishnan Padmakumari Sivaraman; Reeves, Mark L; Heller, Ben; Barker, Anthony T

    2016-02-01

    To assess the feasibility of using a novel form of multichannel electrical stimulation, termed Sensory Barrage Stimulation (SBS) for the treatment of spasticity affecting the elbow flexor muscles and to compare this with conventional single-channel TENS stimulation. Altogether ten participants with spasticity of the flexor muscles of the elbow of Grade 2 or above on the Modified Ashworth Scale (MAS) were recruited to this crossover double blind randomized trial. The participants received two intervention sessions (SBS and TENS), one week apart in a randomized order. Both interventions were applied over the triceps brachii on the affected arm for a duration of 60 minutes. Spasticity was measured using the MAS. Secondary outcome measures were self-reported change in spasticity, measured on a visual analog scale (VAS, 0-100), and therapist-rated strength of elbow extension and strength of elbow flexion. Measurements were taken immediately before each intervention was applied, immediately after the intervention, and one hour after the intervention. Immediately after stimulation spasticity showed a significant reduction for both TENS and SBS groups assessed by MAS -0.9 ± 0.2 vs. -1.1 ± 0.2 and by VAS -15 ± 3 vs. -31 ± 8. For SBS this improvement in MAS was still present at one hour after the stimulation, but not for TENS. Altogether seven SBS responders and four TENS responders were identified. This study demonstrates the feasibility and practicality of applying the new concept of SBS. Promising results indicate it causes a reduction in spasticity. © 2015 International Neuromodulation Society.

  12. Microbial field pilot study. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Knapp, R.M.; McInerney, M.J.; Menzie, D.E.; Coates, J.D.; Chisholm, J.L.

    1993-05-01

    A multi-well microbially enhanced oil recovery field pilot has been performed in the Southeast Vassar Vertz Sand Unit in Payne County, Oklahoma. The primary emphasis of the experiment was preferential plugging of high permeability zones for the purpose of improving waterflood sweep efficiency. Studies were performed to determine reservoir chemistry, ecology, and indigenous bacteria populations. Growth experiments were used to select a nutrient system compatible with the reservoir that encouraged growth of a group of indigenous nitrate-using bacteria and inhibit growth of sulfate-reducing bacteria. A specific field pilot area behind an active line drive waterflood was selected. Surface facilities were designed and installed. Injection protocols of bulk nutrient materials were prepared to facilitate uniform distribution of nutrients within the pilot area. By the end of December, 1991, 82.5 tons (75.0 tonnes) of nutrients had been injected in the field. A tracer test identified significant heterogeneity in the SEVVSU and made it necessary to monitor additional production wells in the field. The tracer tests and changes in production behavior indicate the additional production wells monitored during the field trial were also affected. Eighty two and one half barrels (13.1 m{sup 3}) of tertiary oil have been recovered. Microbial activity has increased CO{sub 2} content as indicated by increased alkalinity. A temporary rise in sulfide concentration was experienced. These indicate an active microbial community was generated in the field by the nutrient injection. Pilot area interwell pressure interference test results showed that significant permeability reduction occurred. The interwell permeabilities in the pilot area between the injector and the three pilot production wells were made more uniform which indicates a successful preferential plugging enhanced oil recovery project.

  13. Tests of Reading Comprehension (TORCH) Pilot Study.

    Science.gov (United States)

    Burgon, J. R.

    A New Zealand pilot study examined Tests of Reading Comprehension (TORCH) scores compared to PAT: Reading Comprehension scores and compared with teacher ratings. TORCH is a reading test package published in 1987 by the Australian Council for Educational Research. It consists of 14 untimed passages intended to assess the extent to which readers in…

  14. Age Integrated Learning: A Pilot Study.

    Science.gov (United States)

    Heckenmueller, Jerome P.; Keller, Ann

    A pilot study on age integrated learning (AIL) was conducted at Aquinas College during spring semester, 1984. (AIL involves the inclusion of students from all adult age groups in higher educational environments.) The purpose of this exploratory research was to collect data that would allow formulation of specific questions regarding (1) potential…

  15. 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 analy...

  16. A randomized, double-blind, placebo-, and positive-controlled clinical pilot study to evaluate the efficacy and tolerability of standardized aqueous extracts of Terminalia chebula and Terminalia bellerica in subjects with hyperuricemia

    Directory of Open Access Journals (Sweden)

    Usharani P

    2016-06-01

    . All the formulations were well tolerated. Conclusion: T. bellerica has the potential for treating hyperuricemia as it was devoid of any serious adverse effects in the present study. Further studies are needed to confirm this potential. Keywords: hyperuricemia, febuxostat, Terminalia chebula, Terminalia bellerica

  17. Mood disturbances during combined oral contraceptive use and the effect of androgen supplementation. Results of a double-blind, placebo-controlled, single-case alternation design pilot study.

    Science.gov (United States)

    Roumen, Frans J M E; Zimmerman, Yvette; van Wijck, Annemieke; Ter Kuile, Moniek M; Onghena, Patrick; Coelingh Bennink, Herjan J T

    2017-04-01

    To evaluate the effect of androgen supplementation in healthy combined oral contraceptive (COC) users who experience mood disturbances during COC-use only. Six women with mood disturbances during COC-use only, received COC with co-treatment of 50 mg dehydroepiandrosterone (DHEA) during three cycles and placebo during another three cycles in an individualized random order. Daily mood rating was measured by a single item: 'In what kind of mood have you been in the past 24 h?' The results were analysed using a randomisation test for single-case experimental designs. The p values for the alternation design randomisation tests on the raw data of the six healthy individuals varied between 0.21 and 1, indicating that the average daily mood ratings of the active treatment DHEA are not statistically significantly larger than the average daily mood ratings of placebo. The combined p value of the subjects using a DRSP-containing pill was 0.97, and of the subjects using an LNG-containing pill was 0.65, indicating no statistically significant treatment effect for any of the pill types. In this single-case alternation design study, concomitant treatment with DHEA for intermittent periods of 4 weeks did not result in improvement of mood disturbances related to COC-use, but had also no side-effects.

  18. A double blind, randomized, placebo controlled trial of the efficacy, quality of life and safety of food allergen-specific sublingual immunotherapy in client owned dogs with adverse food reactions: a small pilot study.

    Science.gov (United States)

    Maina, Elisa; Cox, Eric

    2016-10-01

    Food allergen-specific sublingual immunotherapy (FA-SLIT) has emerged as a novel and successful approach for desensitizing human patients to specific food allergens. It has not been tested in dogs. To investigate the efficacy, quality of life (QoL), tolerability and safety of FA-SLIT in dogs with adverse food reactions (AFR). Dogs with proven AFR were randomized to treatment (T group; n = 7) or placebo (P group; n = 6) to receive either FA-SLIT (based on the results of a food elimination trial) or glycerinated saline, respectively. The treatment was continued daily for 6 months with fortnightly dosage escalations. To evaluate the treatment, pruritus Visual Analog Scale (pVAS), Canine Atopic Dermatitis Extent and Severity Index (CADESI-04), QoL, faecal consistency scores, owner assessment, overall tolerability scores and blood analyses were assessed. Eleven dogs completed the study, two dogs in the T group were withdrawn by the owner after FA-SLIT exacerbated clinical signs of AFR. Statistical tests showed significant protection against food challenge induced clinical signs following FA-SLIT therapy, as indicated by reduced pVAS and CADESI scores (P < 0.05). The QoL did not differ between groups. The treatment was rated as effective or quite effective by 80% of the owners, whereas placebo was rated as ineffective by all owners. FA-SLIT was effective, well tolerated and safe. No severe adverse events were recorded; erythema and pruritus were reported in association with only 0.7% of the dispensed doses. Larger clinical trials with more extended maintenance immunotherapy periods will be needed to provide more precise estimates of efficacy and frequency of adverse events. © 2016 ESVD and ACVD.

  19. 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.

  20. A role of Yueju in fast-onset antidepressant action on major depressive disorder and serum BDNF expression: a randomly double-blind, fluoxetine-adjunct, placebo-controlled, pilot clinical study

    Directory of Open Access Journals (Sweden)

    Wu R

    2015-08-01

    Full Text Available Ruyan Wu,1,* Dandan Zhu,1,* Youchun Xia,2,* Haosen Wang,2 Weiwei Tao,1 Wenda Xue,1 Baomei Xia,1 Li Ren,1 Xin Zhou,1 Guochun Li,3 Gang Chen1 1Center for Translational Systems Biology and Neuroscience, Key Laboratory of Integrative Biomedicine of Brain Diseases, Nanjing University of Chinese Medicine, Nanjing, People’s Republic of China; 2The Fourth People’s Hospital of Taizhou, Taizhou, People’s Republic of China; 3School of Basic Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, People’s Republic of China *These authors contributed equally to this work Introduction: Conventional antidepressants, including fluoxetine, have a major disadvantage in delayed onset of efficacy. Yueju, an herbal medicine used to treat mood disorders was recently found to exhibit rapid antidepressant effects. The present study was conducted to evaluate the role of Yueju in rapidly acting on major depressive disorder (MDD.Methods: Participants were MDD patients with scores of 24-item Hamilton Depression Rating Scale (HDRS-24 ≥20 and without history of antidepressant use. They randomly received daily oral doses of Yueju (23 g/day plus fluoxetine (20 mg/day (experimental group or placebo plus fluoxetine (control group for 7 days. HDRS-24 was used as the primary outcome measurement at baseline, and on days 1, 3, 5, and 7. Concentrations of serum brain-derived neurotrophic factor (BDNF were assessed at baseline and on days 1 and 7.Results: In all, 18 participants met the criteria for data analysis. Compared to baseline level, only experimental group showed significant decrease of HDRS-24 score from day 3 to day 7 (P<0.05. Experimental group also showed significant improvement compared with control group from day 3 to day 7 (P<0.05. No correlation between treatment outcomes with serum BDNF levels was observed. However, experimental group showed significant correlation for serum BDNF level on day 1 with day 7 (r=0.721, P=0.028, whereas the control

  1. Effects of Reiki on Pain, Anxiety, and Blood Pressure in Patients Undergoing Knee Replacement: A Pilot Study.

    Science.gov (United States)

    Baldwin, Ann Linda; Vitale, Anne; Brownell, Elise; Kryak, Elizabeth; Rand, William

    This blinded, controlled pilot study investigated the effects of Reiki on 46 patients undergoing knee replacement surgery. Of the 3 groups, Reiki, Sham Reiki, and Standard of Care, only the Reiki group showed significant reductions in pain, blood pressure, respiration rate, and state anxiety, which provides evidence for a full-scale clinical study.

  2. Acupuncture Treatment of Lateral Elbow Pain: A Nonrandomized Pilot Study

    Directory of Open Access Journals (Sweden)

    Yan-Song Liu

    2016-01-01

    Full Text Available In planning for a large-scale multicenter trial to evaluate the effect of acupuncture for the treatment of lateral elbow pain, a pilot study was conducted. This was a prospective, investigator- and patient-blinded, nonrandomized, placebo controlled trial. Subjects were evaluated at baseline, before fourth, seventh, and ninth treatment, and at a two-week posttreatment follow-up. The treatment group received unilateral acupuncture at LI 10 and LI 11 at the affected side with manual needle manipulation; the control group received sham-laser acupuncture at the same acupoints. Measures included (i disabilities of the arm, shoulder, and hand (DASH questionnaire, (ii pain-free grip strength (PFGS, and (iii a visual analogue scale (VAS for pain. Significant differences in DASH score, PFGS, and VAS between treatment and control group were found at the ninth treatment (n=20 for each group, P<0.05. Only DASH showed significant differences compared to the control for all the measurement time points after treatment commenced and appears to be a sensitive and appropriate primary outcome measure for the future multisite trial. Results from this pilot study provided relevant information about treatment efficacy, credibility of control treatment, and sensitivity of different outcome measures for the planning of the future trial.

  3. Missouri Annual Blind/Visually Impaired Literacy Study, December 2010

    Science.gov (United States)

    Missouri Department of Elementary and Secondary Education, 2010

    2010-01-01

    The Missouri Department of Elementary and Secondary Education, per Section 162.1136 RSMo, conducts an annual study of the educational status of eligible blind/visually impaired students and reports the findings to the Missouri Legislature on December 1st each year. The information contained in this report pertains to the twelve data elements…

  4. Missouri Annual Blind/Visually Impaired Literacy Study, December 2012

    Science.gov (United States)

    Missouri Department of Elementary and Secondary Education, 2012

    2012-01-01

    The Missouri Department of Elementary and Secondary Education, per Section 162.1136 RSMo, conducts an annual study of the educational status of eligible blind/visually impaired students and reports the findings to the Missouri Legislature on December 1st each year. The information contained in this report pertains to the twelve data elements…

  5. Missouri Annual Blind/Visually Impaired Literacy Study, December 2011

    Science.gov (United States)

    Missouri Department of Elementary and Secondary Education, 2011

    2011-01-01

    The Missouri Department of Elementary and Secondary Education, per Section 162.1136 RSMo, conducts an annual study of the educational status of eligible blind/visually impaired students and reports the findings to the Missouri Legislature on December 1st each year. The information contained in this report pertains to the twelve data elements…

  6. 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

  7. Pre-Study Walkthrough with a Commercial Pilot for a Preliminary Single Pilot Operations Experiment

    Science.gov (United States)

    O'Connor-Dreher, Ryan; Roberts, Z.; Ziccardi, J.; Vu, K-P. L.; Strybel, T.; Koteskey, Robert William; Lachter, Joel B.; Vi Dao, Quang; Johnson, Walter W.; Battiste, V.

    2013-01-01

    The number of crew members in commercial flights has decreased to two members, down from the five-member crew required 50 years ago. One question of interest is whether the crew should be reduced to one pilot. In order to determine the critical factors involved in safely transitioning to a single pilot, research must examine whether any performance deficits arise with the loss of a crew member. With a concrete understanding of the cognitive and behavioral role of a co-pilot, aeronautical technologies and procedures can be developed that make up for the removal of the second aircrew member. The current project describes a pre-study walkthrough process that can be used to help in the development of scenarios for testing future concepts and technologies for single pilot operations. Qualitative information regarding the tasks performed by the pilots can be extracted with this technique and adapted for future investigations of single pilot operations.

  8. USGS Tampa Bay Pilot Study

    Science.gov (United States)

    Yates, K.K.; Cronin, T. M.; Crane, M.; Hansen, M.; Nayeghandi, A.; Swarzenski, P.; Edgar, T.; Brooks, G.R.; Suthard, B.; Hine, A.; Locker, S.; Willard, D.A.; Hastings, D.; Flower, B.; Hollander, D.; Larson, R.A.; Smith, K.

    2007-01-01

    Many of the nation's estuaries have been environmentally stressed since the turn of the 20th century and will continue to be impacted in the future. Tampa Bay, one the Gulf of Mexico's largest estuaries, exemplifies the threats that our estuaries face (EPA Report 2001, Tampa Bay Estuary Program-Comprehensive Conservation and Management Plan (TBEP-CCMP)). More than 2 million people live in the Tampa Bay watershed, and the population constitutes to grow. Demand for freshwater resources, conversion of undeveloped areas to resident and industrial uses, increases in storm-water runoff, and increased air pollution from urban and industrial sources are some of the known human activities that impact Tampa Bay. Beginning on 2001, additional anthropogenic modifications began in Tampa Bat including construction of an underwater gas pipeline and a desalinization plant, expansion of existing ports, and increased freshwater withdrawal from three major tributaries to the bay. In January of 2001, the Tampa Bay Estuary Program (TBEP) and its partners identifies a critical need for participation from the U.S. Geological Survey (USGS) in providing multidisciplinary expertise and a regional-scale, integrated science approach to address complex scientific research issue and critical scientific information gaps that are necessary for continued restoration and preservation of Tampa Bay. Tampa Bay stakeholders identified several critical science gaps for which USGS expertise was needed (Yates et al. 2001). These critical science gaps fall under four topical categories (or system components): 1) water and sediment quality, 2) hydrodynamics, 3) geology and geomorphology, and 4) ecosystem structure and function. Scientists and resource managers participating in Tampa Bay studies recognize that it is no longer sufficient to simply examine each of these estuarine system components individually, Rather, the interrelation among system components must be understood to develop conceptual and

  9. A tutorial on pilot studies: the what, why and how

    Directory of Open Access Journals (Sweden)

    Ismaila Afisi

    2010-01-01

    Full Text Available Abstract Pilot studies for phase III trials - which are comparative randomized trials designed to provide preliminary evidence on the clinical efficacy of a drug or intervention - are routinely performed in many clinical areas. Also commonly know as "feasibility" or "vanguard" studies, they are designed to assess the safety of treatment or interventions; to assess recruitment potential; to assess the feasibility of international collaboration or coordination for multicentre trials; to increase clinical experience with the study medication or intervention for the phase III trials. They are the best way to assess feasibility of a large, expensive full-scale study, and in fact are an almost essential pre-requisite. Conducting a pilot prior to the main study can enhance the likelihood of success of the main study and potentially help to avoid doomed main studies. The objective of this paper is to provide a detailed examination of the key aspects of pilot studies for phase III trials including: 1 the general reasons for conducting a pilot study; 2 the relationships between pilot studies, proof-of-concept studies, and adaptive designs; 3 the challenges of and misconceptions about pilot studies; 4 the criteria for evaluating the success of a pilot study; 5 frequently asked questions about pilot studies; 7 some ethical aspects related to pilot studies; and 8 some suggestions on how to report the results of pilot investigations using the CONSORT format.

  10. Blinded with Science or Informed by Charts? A Replication Study

    OpenAIRE

    Dragicevic , Pierre; Jansen , Yvonne

    2018-01-01

    International audience; We provide a reappraisal of Tal and Wansink's study "Blinded with Science" , where seemingly trivial charts were shown to increase belief in drug efficacy, presumably because charts are associated with science. Through a series of four replications conducted on two crowdsourcing platforms, we investigate an alternative explanation, namely, that the charts allowed participants to better assess the drug's efficacy. Considered together, our experiments suggest that the ch...

  11. Comparison of Crocus sativus L. and imipramine in the treatment of mild to moderate depression: A pilot double-blind randomized trial [ISRCTN45683816

    Directory of Open Access Journals (Sweden)

    Jamshidi Amir-Hossein

    2004-09-01

    Full Text Available Abstract Background The morbidity and mortality associated with depression are considerable and continue to increase. Depression currently ranks fourth among the major causes of disability worldwide, after lower respiratory infections, prenatal conditions, and HIV/AIDS. Crocus sativus L. is used to treat depression. Many medicinal plants textbooks refer to this indication whereas there is no evidence-based document. Our objective was to compare the efficacy of stigmas of Crocus sativus (saffron with imipramine in the treatment of mild to moderate depression in a 6-week pilot double-blind randomized trial. Methods Thirty adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders, 4th edition for major depression based on the structured clinical interview for DSM IV participated in the trial. Patients have a baseline Hamilton Rating Scale for Depression score of at least 18. In this double-blind, single-center trial, patients were randomly assigned to receive capsule of saffron 30 mg/day (TDS (Group 1 and capsule of imipramine 100 mg/day (TDS (Group 2 for a 6-week study. Results Saffron at this dose was found to be effective similar to imipramine in the treatment of mild to moderate depression (F = 2.91, d.f. = 1, P = 0.09. In the imipramine group anticholinergic effects such as dry mouth and also sedation were observed more often that was predictable. Conclusion The main overall finding from this study is that saffron may be of therapeutic benefit in the treatment of mild to moderate depression. To the best of our knowledge this is the first clinical trial that supports this indication for saffron. A large-scale trial with placebo control is warranted.

  12. Comparison of Crocus sativus L. and imipramine in the treatment of mild to moderate depression: A pilot double-blind randomized trial [ISRCTN45683816

    Science.gov (United States)

    Akhondzadeh, Shahin; Fallah-Pour, Hasan; Afkham, Khosro; Jamshidi, Amir-Hossein; Khalighi-Cigaroudi, Farahnaz

    2004-01-01

    Background The morbidity and mortality associated with depression are considerable and continue to increase. Depression currently ranks fourth among the major causes of disability worldwide, after lower respiratory infections, prenatal conditions, and HIV/AIDS. Crocus sativus L. is used to treat depression. Many medicinal plants textbooks refer to this indication whereas there is no evidence-based document. Our objective was to compare the efficacy of stigmas of Crocus sativus (saffron) with imipramine in the treatment of mild to moderate depression in a 6-week pilot double-blind randomized trial. Methods Thirty adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders, 4th edition for major depression based on the structured clinical interview for DSM IV participated in the trial. Patients have a baseline Hamilton Rating Scale for Depression score of at least 18. In this double-blind, single-center trial, patients were randomly assigned to receive capsule of saffron 30 mg/day (TDS) (Group 1) and capsule of imipramine 100 mg/day (TDS) (Group 2) for a 6-week study. Results Saffron at this dose was found to be effective similar to imipramine in the treatment of mild to moderate depression (F = 2.91, d.f. = 1, P = 0.09). In the imipramine group anticholinergic effects such as dry mouth and also sedation were observed more often that was predictable. Conclusion The main overall finding from this study is that saffron may be of therapeutic benefit in the treatment of mild to moderate depression. To the best of our knowledge this is the first clinical trial that supports this indication for saffron. A large-scale trial with placebo control is warranted. PMID:15341662

  13. 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.

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

    Energy Technology Data Exchange (ETDEWEB)

    Michel, Patrik [Center Hospitalier Universitaire Vaudois and University of Lausanne, Department of Neurology Service, Lausanne (Switzerland); Centre Hospitalier Universitaire Vaudois and University of Lausanne, Neurology Service, Lausanne (Switzerland); Ntaios, George; Reichhart, Marc [Center Hospitalier Universitaire Vaudois and University of Lausanne, Department of Neurology Service, Lausanne (Switzerland); Schindler, Christian [Center Hospitalier Universitaire Vaudois and University of Lausanne, Pharmacy Department, Lausanne (Switzerland); Bogousslavsky, Julien [Genolier Swiss Medical Network, Glion (Switzerland); Maeder, Philip; Meuli, Reto [Center Hospitalier Universitaire Vaudois and University of Lausanne, Department of Radiology, Lausanne (Switzerland); Wintermark, Max [University of Virginia, Department of Radiology, Division of Neuroradiology, Charlottesville, VA (United States)

    2012-06-15

    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{sup 3} in the treatment arm and 29 (8-105) cm{sup 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.)

  15. 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.)

  16. Cytogenetics of jaw cysts - a pilot study.

    Science.gov (United States)

    Manor, Esther; Brennan, Peter A; Bodner, Lipa

    2012-07-01

    The pathogenesis of cysts that arise in the jaws is still not certain, and the underlying mechanisms of epithelial proliferation are not fully understood. Cysts of the jaw may involve a reactive, inflammatory, or neoplastic process. Cytogenetics, the study of the number and structure of chromosomes, has provided valuable information about the diagnosis, prognosis, and targeted treatment in many cancers, including oral squamous cell carcinoma. Cytogenetics can also provide information about the possible aetiology or neoplastic potential of a lesion, though to our knowledge no studies of this technique have been used for cysts in the jaws. In this pilot study we used cytogenetics in a series of 10 cysts (3 radicular, 4 dentigerous, 2 of the nasopalatine duct, and 1 dermoid). In all cases we found normal karyotypes. Further work and larger numbers are needed for a definitive study, but we can hypothesise from this pilot study that these cysts do not have cytogenetic aberrations and so have no neoplastic potential. Copyright © 2011 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  17. Prolonged release melatonin for improving sleep in totally blind subjects: a pilot placebo-controlled multicenter trial

    Directory of Open Access Journals (Sweden)

    Roth T

    2015-01-01

    Full Text Available Thomas Roth,1 Tali Nir,2 Nava Zisapel2,3 1Henry Ford Sleep Disorders Center, Detroit, MI, USA; 2Neurim Pharmaceuticals Ltd, Tel Aviv, Israel; 3Department of Neurobiology Faculty of Life Sciences, Tel Aviv University, Tel Aviv, Israel Introduction: Melatonin, secreted by the pineal gland during the night phase, is a regulator of the biological clock and sleep tendency. Totally blind subjects frequently report severe, periodic sleep problems, with 50%–75% of cases displaying non-24-hour sleep–wake disorder (N24HSWD due to inability to synchronize with the environmental day–night cycle. Melatonin immediate-release preparations are reportedly effective in N24HSWD. Here, we studied the efficacy and safety of prolonged-release melatonin (PRM, a registered drug for insomnia, for sleep disorders in totally blind subjects living in normal social environments. The primary endpoint was demonstration of clinically meaningful effects on sleep duration (upper confidence interval [CI] limit >20 minutes whether significant or not to allow early decision-making on further drug development in this indication. Trial registration: ClinicalTrials.gov registry – NCT00972075. Methods: In a randomized, double-blind, placebo-controlled proof-of-principle study, 13 totally blind subjects had 2 weeks' placebo run-in, 6 weeks' randomized (1:1 PRM (Circadin® or placebo nightly, and 2 weeks' placebo run-out. Outcome measures included daily voice recorded sleep diary, Clinical Global Impression of Change (CGIC, WHO-Five Well-being Index (WHO-5, and safety. Results: Mean nightly sleep duration improved by 43 minutes in the PRM and 16 minutes in the placebo group (mean difference: 27 minutes, 95% CI: -14.4 to 69 minutes; P=0.18; effect size: 0.82 meeting the primary endpoint. Mean sleep latency decreased by 29 minutes with PRM over placebo (P=0.13; effect size: 0.92 and nap duration decreased in the PRM but not placebo group. The variability in sleep onset/offset and

  18. Human biomonitoring pilot study DEMOCOPHES in Germany

    DEFF Research Database (Denmark)

    Schwedler, Gerda; Seiwert, Margarete; Fiddicke, Ulrike

    2017-01-01

    Human biomonitoring (HBM) is an effective tool to assess human exposure to environmental pollutants, but comparable HBM data in Europe are lacking. In order to expedite harmonization of HBM studies on a European scale, the twin projects COPHES (Consortium to Perform Human Biomonitoring...... on a European Scale) and DEMOCOPHES (Demonstration of a study to Coordinate and Perform Human Biomonitoring on a European Scale) were formed, comprising 35 partners from 27 European countries. In COPHES a research scheme and guidelines were developed to exemplarily measure in a pilot study mercury in hair......, cadmium, cotinine and several phthalate metabolites in urine of 6–11 year old children and their mothers in an urban and a rural region. Seventeen European countries simultaneously conducted this cross-sectional DEMOCOPHES feasibility study. The German study population was taken in the city of Bochum...

  19. Epidemiologic studies of pilots and aircrew.

    Science.gov (United States)

    Boice, J D; Blettner, M; Auvinen, A

    2000-11-01

    During flight, pilots and cabin crew are exposed to increased levels of cosmic radiation which consists primarily of neutrons and gamma rays. Neutron dosimetry is not straightforward, but typical annual effective doses are estimated to range between two and five mSv. Higher dose rates are experienced at the highest altitudes and in the polar regions. Mean doses have been increasing over time as longer flights at higher altitudes have become more frequent. Because there are so few populations exposed to neutrons, studies of airline personnel are of particular interest. However, because the cumulative radiation exposure is so low, statistical power is a major concern. Further, finding an appropriate comparison group is problematic due to selection into these occupations and a number of biases are possible. For example, increased rates of breast cancer among flight attendants have been attributed to reproductive factors such as nulliparity and increased rates of melanoma among pilots have been attributed to excessive sun exposure during leisure time activities. Epidemiologic studies conducted over the last 20 y provide little consistent evidence linking cancer with radiation exposures from air travel.

  20. PACAP38 dose-response pilot study in migraine patients

    DEFF Research Database (Denmark)

    Vollesen, Anne Luise Haulund; Guo, Song; Ashina, Messoud

    2017-01-01

    Background Intravenous infusion of 10 pmol/kg/min pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) induces migraine-like attacks in migraine patients without aura (MO). Here, we conducted a pilot study and investigated if lower doses of PACAP38 exert similar migraine......-inducing abilities. Methods We randomly allocated six MO patients to receive intravenous infusion of 4, 6, and 8 pmol/kg/min of PACAP38 over 20 minutes in a double-blind, three-way cross-over study. Headache and migraine characteristics were recorded during hospital (0-2 hours) and post-hospital (2-13 hours) phases....... Results PACAP38 induced migraine-like attacks in one out of six patients with 4 pmol, two out of six patients with 6 pmol and three out of six patients with 8 pmol ( p = 0.368). All patients reported head pain after 8 pmol/kg/min, whereas five of six participants reported head pain after both 4 and 6 pmol...

  1. Longitudinal Study of Gross-Motor Development in Blind Infants and Preschoolers.

    Science.gov (United States)

    Troster, Heinrich; And Others

    1994-01-01

    Reports on a longitudinal study of gross-motor development in 10 congenitally blind children during their first 3 years. Compared to developmental norms for sighted children, five full-term blind children showed slight delays in postural development but greater delays in locomotor development. Five preterm blind children showed major delays in all…

  2. Location Independent Professional Project: A Pilot Study

    Energy Technology Data Exchange (ETDEWEB)

    Hudson, J.A.; Long, J.P.; Miller, M.M.

    1999-02-01

    This pilot study project explored the problem of providing access to the nomadic worker who desires to connect a computer through network access points at a number of different locations within the SNL/NM campus as well as outside the campus. The design and prototype development gathered knowledge that may allow a design to be developed that could be extended to a larger number of SNL/NM network drop boxes. The focus was to provide a capability for a worker to access the SNL IRN from a network drop box (e.g. in a conference room) as easily as when accessing the computer network from the office normally used by the worker. Additional study was done on new methods to authenticate the off campus worker, and protect and control access to data.

  3. Diabetic Retinopathy Screening Using Telemedicine Tools: Pilot Study in Hungary

    Directory of Open Access Journals (Sweden)

    Dóra J. Eszes

    2016-01-01

    Full Text Available Introduction. Diabetic retinopathy (DR is a sight-threatening complication of diabetes. Telemedicine tools can prevent blindness. We aimed to investigate the patients’ satisfaction when using such tools (fundus camera examination and the effect of demographic and socioeconomic factors on participation in screening. Methods. Pilot study involving fundus camera screening and self-administered questionnaire on participants’ experience during fundus examination (comfort, reliability, and future interest in participation, as well as demographic and socioeconomic factors was performed on 89 patients with known diabetes in Csongrád County, a southeastern region of Hungary. Results. Thirty percent of the patients had never participated in any ophthalmological screening, while 25.7% had DR of some grade based upon a standard fundus camera examination and UK-based DR grading protocol (Spectra™ software. Large majority of the patients were satisfied with the screening and found it reliable and acceptable to undertake examination under pupil dilation; 67.3% were willing to undergo nonmydriatic fundus camera examination again. There was a statistically significant relationship between economic activity, education and marital status, and future interest in participation. Discussion. Participants found digital retinal screening to be reliable and satisfactory. Telemedicine can be a strong tool, supporting eye care professionals and allowing for faster and more comfortable DR screening.

  4. Microwave Imaging of Human Forearms: Pilot Study and Image Enhancement

    Directory of Open Access Journals (Sweden)

    Colin Gilmore

    2013-01-01

    Full Text Available We present a pilot study using a microwave tomography system in which we image the forearms of 5 adult male and female volunteers between the ages of 30 and 48. Microwave scattering data were collected at 0.8 to 1.2 GHz with 24 transmitting and receiving antennas located in a matching fluid of deionized water and table salt. Inversion of the microwave data was performed with a balanced version of the multiplicative-regularized contrast source inversion algorithm formulated using the finite-element method (FEM-CSI. T1-weighted MRI images of each volunteer’s forearm were also collected in the same plane as the microwave scattering experiment. Initial “blind” imaging results from the utilized inversion algorithm show that the image quality is dependent on the thickness of the arm’s peripheral adipose tissue layer; thicker layers of adipose tissue lead to poorer overall image quality. Due to the exible nature of the FEM-CSI algorithm used, prior information can be readily incorporated into the microwave imaging inversion process. We show that by introducing prior information into the FEM-CSI algorithm the internal anatomical features of all the arms are resolved, significantly improving the images. The prior information was estimated manually from the blind inversions using an ad hoc procedure.

  5. The Pilot Staffing Conundrum: A Delphi Study

    Science.gov (United States)

    2009-06-01

    Project, AFIT/ GMO /LAL/98J-2. School of Logistics and Acquisition Management, Air Force Institute of Technology (AU), Wright Patterson AFB, OH, June...Kafer, John H. Relationship of Airline Pilot Demand and Air Force Pilot Retention. Graduate Research Project, AFIT/ GMO /LAL/98J-11. School of Logistics

  6. The incidence of venous thromboembolism in commercial airline pilots: a cohort study of 2630 pilots.

    Science.gov (United States)

    Kuipers, S; Venemans-Jellema, A; Cannegieter, S C; van Haften, M; Middeldorp, S; Büller, H R; Rosendaal, F R

    2014-08-01

    Airline pilots may be at increased risk of venous thromboembolism (VTE) because air travel has recently been established as a risk factor for VTE. The aim of this study was to assess the risk of VTE in a cohort of Dutch airline pilots. Airline pilots who had been active members of the Dutch aviation society (VNV) were questioned for the occurrence of VTE, presence of risk factors for VTE and number of flight hours per year and rank. Incidence rates among pilots were compared with those of the general Dutch population and with a population of frequently flying employees of multinational organizations. A total of 2630 male pilots were followed-up for a total of 20420 person-years (py). Six venous thromboses were reported, yielding an incidence rate of 0.3 per 1000 py. The standardized morbidity ratio, comparing these pilots with the general Dutch population adjusted for age, was 0.8. Compared with the international employee cohort, the standardized morbidity ratio was 0.7 when all employees were included and 0.6 when only the frequently travelling employees were included. The incidence rate did not increase with number of flight hours per year and did not clearly vary by rank. We conclude that the risk of VTE is not increased amongst airline pilots. © 2014 International Society on Thrombosis and Haemostasis.

  7. Change Blindness in Information Visualization: a Case Study

    Energy Technology Data Exchange (ETDEWEB)

    Nowell, Lucy T.; Hetzler, Elizabeth G.; Tanasse, Ted E.

    2001-08-20

    Change blindness occurs when people do not notice changes in visible elements of a scene. In using an information visualization system to compare document collection subsets partitioned by their time-stamps, change blindness makes it impossible for users to recognize even very major changes, let alone minor ones. We describe theories from cognitive science that account for the change blindness phenomenon, as well as solutions developed for two visual analysis tools, the SPIRE Galaxies visualization and the SPIRE ThemeView?.

  8. Acting upon dynamic speed limits: Is change blindness involved?

    NARCIS (Netherlands)

    Harms, Ilse; Brookhuis, Karel; Mrowinski, Vicky

    2010-01-01

    Dynamic speed limits are the latest traffic management pilot in the Netherlands. Being dynamic they can vary during the day. Previous studies showed difficulties with noticing small changes, also called change blindness. These change blindness studies have mainly been conducted using static scenes

  9. Change Blindness in Information Visualization: A Case Study

    Energy Technology Data Exchange (ETDEWEB)

    Nowell, Lucille T.; Hetzler, Elizabeth G.; Tanasse, Theodore E.

    2001-08-20

    AbstractChange blindness occurs when people do not notice changes in visible elements of a scene. If people use an infor-mation visualization system to compare document collec-tion subsets partitioned by their time-stamps, change blind-ness makes it impossible for them to recognize even very major changes, let alone minor ones. We describe theories from cognitive science that account for the change blindness phenomenon, as well as solutions de-veloped for two visual analysis tools, a dot plot (SPIRE Galaxies) and landscape (ThemeView?) visualizations.

  10. Evaluation of craniofacial proportions: A pilot study.

    Science.gov (United States)

    Sadeghian, Saied; Motamedi, Ali Mohammad Kalantar; Haerian, Alireza; Rafiei, Elahe

    2015-01-01

    Regarding the need for determining the cephalometric norms for each population and the advantages of proportional analyses, we evaluated the variables of McNamara and Schwartz analyses and their relation in a pilot study on 6-17 years old Iranian students and provided formulas, which show these relations. In this descriptive-analytical study, a tatal of cephalometric radiographs from the archive documents of Orthodontic Department of Isfahan Dental School was selected and traced. The variables of McNamara and Schwartz analyses were investigated. The data were analyzed by t-test and linear regression and Spearman correlation coefficient tests using SPSS 12 software, and the significance was set at 0.05. Then, a formula was suggested for predicting the relation between the jaws, cranium and face. The variables measured in this study were significantly different between the genders (P < 0.05), except for Co-Gn (P = 0.055), and they were higher in boys. All variables significantly increased (P < 0.05) with age from 6 to 17 years. The formulas presented in this study can be used for calculating the amount of PNS-APmax, Go-APmax and the Co-Gn, anterior nasal spine-menton in the Iranian population. Within the limitation of this study, the formula presented in this study might be considered to predict the relation between jaw dimensions and cranial base and facial dimensions in the Iranian population.

  11. CYCLE pilot: a protocol for a pilot randomised study of early cycle ergometry versus routine physiotherapy in mechanically ventilated patients.

    Science.gov (United States)

    Kho, Michelle E; Molloy, Alexander J; Clarke, France; Herridge, Margaret S; Koo, Karen K Y; Rudkowski, Jill; Seely, Andrew J E; Pellizzari, Joseph R; Tarride, Jean-Eric; Mourtzakis, Marina; Karachi, Timothy; Cook, Deborah J

    2016-04-08

    Early exercise with in-bed cycling as part of an intensive care unit (ICU) rehabilitation programme has the potential to improve physical and functional outcomes following critical illness. The objective of this study is to determine the feasibility of enrolling adults in a multicentre pilot randomised clinical trial (RCT) of early in-bed cycling versus routine physiotherapy to inform a larger RCT. 60-patient parallel group pilot RCT in 7 Canadian medical-surgical ICUs. We will include all previously ambulatory adult patients within the first 0-4 days of mechanical ventilation, without exclusion criteria. After informed consent, patients will be randomised using a web-based, centralised electronic system, to 30 min of in-bed leg cycling in addition to routine physiotherapy, 5 days per week, for the duration of their ICU stay (28 days maximum) or routine physiotherapy alone. We will measure patients' muscle strength (Medical Research Council Sum Score, quadriceps force) and function (Physical Function in ICU Test (scored), 30 s sit-to-stand, 2 min walk test) at ICU awakening, ICU discharge and hospital discharge. Our 4 feasibility outcomes are: (1) patient accrual of 1-2 patients per month per centre, (2) protocol violation rate 80% at the 3 time points and (4) blinded outcomes ascertainment >80% at hospital discharge. Hospital outcome assessors are blinded to group assignment, whereas participants, ICU physiotherapists, ICU caregivers, research coordinators and ICU outcome assessors are not blinded to group assignment. We will analyse feasibility outcomes with descriptive statistics. Each participating centre will obtain local ethics approval, and results of the study will be published to inform the design and conduct of a future multicentre RCT of in-bed cycling to improve physical outcomes in ICU survivors. NCT02377830; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please

  12. Randomised controlled trial of extraarticular gold bead implantation for treatment of knee osteoarthritis: a pilot study

    DEFF Research Database (Denmark)

    Nejrup, Kirsten; Olivarius, Niels de Fine; Jacobsen, Judith L.

    2008-01-01

    The primary objective of this double-blind, randomised, controlled trial was to determine if implanting gold beads at five acupuncture points around the knee joint improves 1-year outcomes for patients with osteoarthritis (OA) of the knee. Participants were 43 adults aged 18-80 years with pain...... and stiffness from non-specific OA of the knee for over a year. The intervention was blinded implantation of gold beads at five acupuncture points around the affected knee through a hypodermic needle, or needle insertion alone. Primary outcome measures were knee pain, stiffness and function assessed...... acupuncture had greater relative improvements in self-assessed outcomes. The treatment was well tolerated. This 1-year pilot study indicates that extraarticular gold bead implantation is a promising treatment modality for patients with OA of the knee. The new treatment should be tested in a larger trial...

  13. Favourable effects of consuming a Palaeolithic-type diet on characteristics of the metabolic syndrome : a randomized controlled pilot-study

    NARCIS (Netherlands)

    Boers, Inge; Muskiet, Frits A. J.; Berkelaar, Evert; Schut, Erik; Penders, Ria; Hoenderdos, Karine; Wichers, Harry J.; Jong, Miek C.

    2014-01-01

    Background: The main goal of this randomized controlled single-blinded pilot study was to study whether, independent of weight loss, a Palaeolithic-type diet alters characteristics of the metabolic syndrome. Next we searched for outcome variables that might become favourably influenced by a

  14. Favourable effects of consuming a Palaeolithic-type diet on characteristics of the metabolic syndrome: a randomized controlled pilot-study

    NARCIS (Netherlands)

    Boers, I.; Muskiet, F.A.J.; Berkelaar, E.; Schut, E.; Penders, R.; Hoenderdos, K.; Jong, de M.C.; Wichers, H.J.

    2014-01-01

    Background The main goal of this randomized controlled single-blinded pilot study was to study whether, independent of weight loss, a Palaeolithic-type diet alters characteristics of the metabolic syndrome. Next we searched for outcome variables that might become favourably influenced by a

  15. Controlling hypertension and hypotension immediately post-stroke (CHHIPS): a randomised, placebo-controlled, double-blind pilot trial.

    Science.gov (United States)

    Potter, John F; Robinson, Thompson G; Ford, Gary A; Mistri, Amit; James, Martin; Chernova, Julia; Jagger, Carol

    2009-01-01

    Raised blood pressure is common after acute stroke and is associated with an adverse prognosis. We sought to assess the feasibility, safety, and effects of two regimens for lowering blood pressure in patients who have had a stroke. Patients who had cerebral infarction or cerebral haemorrhage and were hypertensive (systolic blood pressure [SBP] >160 mm Hg) were randomly assigned by secure internet central randomisation to receive oral labetalol, lisinopril, or placebo if they were non-dysphagic, or intravenous labetalol, sublingual lisinopril, or placebo if they had dysphagia, within 36 h of symptom onset in this double-blind pilot trial. The doses were titrated up if target blood pressure was not reached. Analysis was by intention to treat. This trial is registered with the National Research Register, number N0484128008. 179 patients (mean age 74 [SD 11] years; SBP 181 [SD 16] mm Hg; diastolic blood pressure [DBP] 95 [SD 13] mm Hg; median National Institutes of Health stroke scale [NIHSS] score 9 [IQR 5-16] points) were randomly assigned to receive labetolol (n=58), lisinopril (n=58), or placebo (n=63) between January, 2005, and December, 2007. The primary outcome--death or dependency at 2 weeks--occurred in 61% (69) of the active and 59% (35) of the placebo group (relative risk [RR] 1.03, 95% CI 0.80-1.33; p=0.82). There was no evidence of early neurological deterioration with active treatment (RR 1.22, 0.33-4.54; p=0.76) despite the significantly greater fall in SBP within the first 24 h in this group compared with placebo (21 [17-25] mm Hg vs 11 [5-17] mm Hg; p=0.004). No increase in serious adverse events was reported with active treatment (RR 0.91, 0.69-1.12; p=0.50) but 3-month mortality was halved (9.7%vs 20.3%, hazard ratio [HR] 0.40, 95% CI 0.2-1.0; p=0.05). Labetalol and lisinopril are effective antihypertensive drugs in acute stroke that do not increase serious adverse events. Early lowering of blood pressure with lisinopril and labetalol after acute

  16. Pilot Study To Examine Training Eligibility Standards

    National Research Council Canada - National Science Library

    Williams, Eric B; Greenston, Peter M

    2006-01-01

    ... the appropriateness of their Aptitude Area (AA) cut scores. For the initial effort in this pilot, the 50 MOS investigated belonged to a handful of school proponents who expressed an interest in the objectives...

  17. Study of occupational stress among railway engine pilots

    Science.gov (United States)

    Kumar, Devesh; Singh, Jai Vir; Kharwar, Poonam S.

    2011-01-01

    Background: Traffic volume and speed is going to be increased in Indian Railways successively, leading to higher stress in staff connected with train operations. The jobs of railway engine pilots come under the category of high-strain jobs, necessitating a need to conduct multicentric study to unfold the factors associated with occupational stress and organizational strategies. Materials and Methods: Present study covered 185 railway engine pilots and office clerks working in various railway zones by incidental method. Occupational Stress Index (OSI) test developed by Srivastva and Singh, questionnaire of specific stressors constructed by authors and laboratory test battery for psychological screening of high-speed train pilots were used as tools. Results: Means of OSI and all the 12 occupational stressors of railway engine pilots were found significantly higher to that of office clerks. Means of OSI and occupational stressors of goods train pilots were significantly higher in comparison to high-speed train pilots and passenger train pilots. Study revealed positive correlation of speed perception and complex reaction time tests and negative correlation of other constituent tests of laboratory test battery to OSI test. Highest subgroup of stressor observedwas role overload followed by role conflict. Conclusions: These findings provide a prima facie evidence of higher occupational stress among railway engine pilots because of identified specific stressors prevalent in their job and explore the possible intervention strategies for its reduction. Significant correlation is noticed between OSI and laboratory test results, indicating its relevant utility in preliminary psychological screening. PMID:21808497

  18. Johrei Family Healing: A Pilot Study

    OpenAIRE

    Canter, P. H.; Brown, L. B.; Greaves, C.; Ernst, E.

    2006-01-01

    Johrei is a form of spiritual healing comprising “energy channelling” and light massage given either by a trained healer or, after some basic training, by anyone. This pilot trial aimed to identify any potential benefits of family-based Johrei practice in childhood eczema and for general health and to establish the feasibility of a subsequent randomised controlled trial. Volunteer families of 3-5 individuals, including at least one child with eczema were recruited to an uncontrolled pilot t...

  19. A STUDY ON PREVALENCE AND CAUSES OF CORNEAL BLINDNESS IN PAEDIATRIC AGE GROUP

    Directory of Open Access Journals (Sweden)

    E. Ramadevi

    2017-12-01

    Full Text Available BACKGROUND Corneal disease is responsible for less than 2% of blindness in children in industrialised countries. In poor countries of the world, corneal scarring occurs due to vitamin A deficiency, measles and ophthalmia neonatorum. Thus, corneal disease is an important cause of blindness among children living in developing nations, which already carry a major burden of blindness. The aim of the study is to study the1. Prevalence of corneal blindness in the paediatric age group. 2. Causes of corneal blindness in the paediatric age group. 3. Morbidity of corneal blindness in the paediatric age group. MATERIALS AND METHODS It was cross-sectional observational study. Study Period- December 2014 to August 2016. Study Done- Government General Hospital, Kakinada. Sample Size- 50 patients. Inclusion Criteria- Children of age group 6 to 12 years with corneal blindness who have attended the outpatient department during the study period. Exclusion Criteria- Children with childhood blindness other than corneal pathology. Study Tools- Predesigned, semi-structured questionnaire regarding age, sex and age of onset of visual loss, laterality, history of ocular injury, vitamin A immunisation, family history of consanguinity and place of residence and socioeconomic status was taken. Visual acuity was measured using an E optotype and Landolt broken C chart with best corrected vision. Visual loss was classified according to the WHO categories of visual impairment. Ophthalmic examination was done by slit lamp and B scan. RESULTS Ocular trauma and corneal ulcers are most common cause of corneal blindness. 84% of corneal blindness cases were preventable and curable. CONCLUSION Trauma was the commonest cause of corneal blindness followed by infectious keratitis. 84% of corneal blindness was preventable and curable. Most causes of corneal blindness were avoidable.

  20. A Pilot Study of Omalizumab in Eosinophilic Esophagitis

    Science.gov (United States)

    Loizou, Denise; Enav, Benjamin; Komlodi-Pasztor, Edina; Hider, Pamela; Kim-Chang, Julie; Noonan, Laura; Taber, Tabitha; Kaushal, Suhasini; Limgala, Renuka; Brown, Margaret; Gupta, Raavi; Balba, Nader; Goker-Alpan, Ozlem; Khojah, Amer; Alpan, Oral

    2015-01-01

    Eosinophilic disorders of the gastrointestinal tract are an emerging subset of immune pathologies within the spectrum of allergic inflammation. Eosinophilic Esophagitis (EoE), once considered a rare disease, is increasing in incidence, with a rate of over 1 in 10,000 in the US, for unknown reasons. The clinical management of EoE is challenging, thus there is an urgent need for understanding the etiology and pathophysiology of this eosinophilic disease to develop better therapeutic approaches. In this open label, single arm, unblinded study, we evaluated the effects of an anti-IgE treatment, omalizumab, on local inflammation in the esophagus and clinical correlates in patients with EoE. Omalizumab was administered for 12 weeks to 15 subjects with long standing EoE. There were no serious side effects from the treatment. Esophageal tissue inflammation was assessed both before and after therapy. After 3 months on omalizumab, although tissue Immunoglobulin E (IgE) levels were significantly reduced in all but two of the subjects, we found that full remission of EoE, which is defined as histologic and clinical improvement only in 33% of the patients. The decrease in tryptase-positive cells and eosinophils correlated significantly with the clinical outcome as measured by improvement in endoscopy and symptom scores, respectively. Omalizumab-induced remission of EoE was limited to subjects with low peripheral blood absolute eosinophil counts. These findings demonstrate that in a subset of EoE patients, IgE plays a role in the pathophysiology of the disease and that anti-IgE therapy with omalizumab may result in disease remission. Since this study is open label there is the potential for bias, hence the need for a larger double blind placebo controlled study. The data presented in this pilot study provides a foundation for proper patient selection to maximize clinical efficacy. Trial Registration ClinicalTrials.gov NCT01040598 PMID:25789989

  1. A pilot study of omalizumab in eosinophilic esophagitis.

    Directory of Open Access Journals (Sweden)

    Denise Loizou

    Full Text Available Eosinophilic disorders of the gastrointestinal tract are an emerging subset of immune pathologies within the spectrum of allergic inflammation. Eosinophilic Esophagitis (EoE, once considered a rare disease, is increasing in incidence, with a rate of over 1 in 10,000 in the US, for unknown reasons. The clinical management of EoE is challenging, thus there is an urgent need for understanding the etiology and pathophysiology of this eosinophilic disease to develop better therapeutic approaches. In this open label, single arm, unblinded study, we evaluated the effects of an anti-IgE treatment, omalizumab, on local inflammation in the esophagus and clinical correlates in patients with EoE. Omalizumab was administered for 12 weeks to 15 subjects with long standing EoE. There were no serious side effects from the treatment. Esophageal tissue inflammation was assessed both before and after therapy. After 3 months on omalizumab, although tissue Immunoglobulin E (IgE levels were significantly reduced in all but two of the subjects, we found that full remission of EoE, which is defined as histologic and clinical improvement only in 33% of the patients. The decrease in tryptase-positive cells and eosinophils correlated significantly with the clinical outcome as measured by improvement in endoscopy and symptom scores, respectively. Omalizumab-induced remission of EoE was limited to subjects with low peripheral blood absolute eosinophil counts. These findings demonstrate that in a subset of EoE patients, IgE plays a role in the pathophysiology of the disease and that anti-IgE therapy with omalizumab may result in disease remission. Since this study is open label there is the potential for bias, hence the need for a larger double blind placebo controlled study. The data presented in this pilot study provides a foundation for proper patient selection to maximize clinical efficacy.

  2. Climatotherapy in Japan: a pilot study

    Science.gov (United States)

    Kanayama, Hitomi; Kusaka, Yukinori; Hirai, Takayoshi; Inoue, Hiroyuki; Agishi, Yuko; Schuh, Angela

    2017-12-01

    Twenty-nine urban inhabitants participated in a half-day climatotherapy programme at the moderate mountain area and lowland area in the northwest part of the main island of Japan. The current study was aimed to investigate physically and mentally the objective and subjective influence of our short programme, which was a prospective pilot study of single intervention. Blood pressure was significantly descended during terrain cure at the uphill mountain path and returned after fresh-air rest cure, while there was no significant change throughout the programme at lowland flat path. Heart rate was significantly ascended and descended at both area, and more clearly changed at the mountain path. Profile of Mood Status brief form Japanese version administered before and after our half-day programme. Age adjusted T score of negative subscales, `tension-anxiety', `depression', `anger-hostility', `fatigue' and `confusion' were significantly lower after climatotherapy at both sites. Whereas, there was no significant change concerning `vigour' score. This short-version climatotherapy programme has been designed for people without enough time for long stay at health resort. It turned out our half-day climatotherapy programme contribute to mood status improvement. In addition, repeated practice of our short-version programme including endurance exercise with cool body shell using uphill path can be expected that blood pressure will go toward the normal range and heart rate will decrease both in usual time and during exercise. Therefore, health benefits can be expected of this climatotherapy programme.

  3. [Mobbing in nursing. A pilot study].

    Science.gov (United States)

    Fornés Vives, Joana; Reinés Femenia, Joan; Sureda García, Catalina

    2004-09-01

    While planning to help shed light on the phenomenon of mobbing in the work place and to develop an instrument by which to measure it, the authors carried out a pilot study in which 160 persons from varying professional classes and autonomous communities in Spain participated, 65 of whom were nurses whose ages lie between 20 and 48 years, with a medium age of 33.98. By means of a factorial analysis, the authors discovered that the most common mobbing practices are grouped in a set of eight factors; these eight factors cover 74.17% of all the various factors. The two most significant factors refer to behaviors which can be considered to be personal humiliation and professional discredit. The most common mobbing practice, according to the overall findings of this study group, consists in providing contradictory information to the victim (19.4% once or more times per week), while in nursing, this practice consists of exposing the victim to criticism by the group (50%).

  4. Pilot plant study for ethanol production

    Energy Technology Data Exchange (ETDEWEB)

    Kim, J.S. [Korea Inst. of Science and Technology, Seoul (Korea, Republic of)

    1996-02-01

    Most of domestic alcohol fermentation factory adopt batch process of which productivity is lower than continuous fermentation process. They have made great effort to increase productivity by means of partial unit process automatization and process improvement with their accumulated experience but there is technical limitation in productivity of batch fermentation process. To produce and supply fuel alcohol, economic aspects must be considered first of all. Therefore, development of continuous fermentation process, of which productivity is high, is prerequisite to produce and use fuel alcohol but only a few foreign company possess continuous fermentation technic and use it in practical industrial scale fermentation. We constructed pilot plant (5 Stage CSTR 1 kl 99.5 v/v% ethanol/Day scale) to study some aspects stated below and our ultimate aims are production of industrial scale fuel alcohol and construction of the plant by ourselves. Some study concerned with energy saving separation and contamination control technic were entrusted to KAIST, A-ju university and KIST respectively. (author) 67 refs., 100 figs., 58 tabs.

  5. The DOE Water Cycle Pilot Study

    Energy Technology Data Exchange (ETDEWEB)

    Miller, N.L.; King, A.W.; Miller, M.A.; Springer, E.P.; Wesely, M.L.; Bashford, K.E.; Conrad, M.E.; Costigan, K.; Foster, P.N.; Gibbs, H.K.; Jin, J.; Klazura, J.; Lesht, B.M.; Machavaram, M.V.; Pan, F.; Song, J.; Troyan, D.; Washington-Allen, R.A.

    2003-09-20

    A Department of Energy (DOE) multi-laboratory Water Cycle Pilot Study (WCPS) investigated components of the local water budget at the Walnut River Watershed in Kansas to study the relative importance of various processes and to determine the feasibility of observational water budget closure. An extensive database of local meteorological time series and land surface characteristics was compiled. Numerical simulations of water budget components were generated and, to the extent possible, validated for three nested domains within the Southern Great Plains; the DOE Atmospheric Radiation Measurement/Cloud Atmospheric Radiation Testbed (ARM/CART), the Walnut River Watershed (WRW), and the Whitewater Watershed (WW), Kansas A 2-month Intensive Observation Period (IOP) was conducted to gather detailed observations relevant to specific details of the water budget, including fine-scale precipitation, streamflow, and soil moisture measurements not made routinely by other programs. Event and season al water isotope (delta 18O, delta D) sampling in rainwater, streams, soils, lakes, and wells provided a means of tracing sources and sinks within and external to the WW, WRW, and the ARM/CART domains. The WCPS measured changes in leaf area index for several vegetation types, deep groundwater variations at two wells, and meteorological variables at a number of sites in the WRW. Additional activities of the WCPS include code development toward a regional climate model with water isotope processes, soil moisture transect measurements, and water level measurements in ground water wells.

  6. Aspirating and Nonaspirating Swallow Sounds in Children: A Pilot Study.

    Science.gov (United States)

    Frakking, Thuy; Chang, Anne; O'Grady, Kerry; David, Michael; Weir, Kelly

    2016-12-01

    Cervical auscultation (CA) may be used to complement feeding/swallowing evaluations when assessing for aspiration. There are no published pediatric studies that compare the properties of sounds between aspirating and nonaspirating swallows. To establish acoustic and perceptual profiles of aspirating and nonaspirating swallow sounds and determine if a difference exists between these 2 swallowing types. Aspiration sound clips were obtained from recordings using CA simultaneously undertaken with videofluoroscopic swallow study. Aspiration was determined using the Penetration-Aspiration Scale. The presence of perceptual swallow/breath parameters was rated by 2 speech pathologists who were blinded to the type of swallow. Acoustic data between groups were compared using Mann Whitney U-tests, while perceptual differences were determined by a test of 2 proportions. Combinations of perceptual parameters of 50 swallows (27 aspiration, 23 no aspiration) from 47 children (57% male) were statistically analyzed using area under a receiver operating characteristic (aROC), sensitivity, specificity, and positive and negative predictive values to determine predictors of aspirating swallows. The combination of post-swallow presence of wet breathing and wheeze and absence of GRS and normal breathing was the best predictor of aspiration (aROC = 0.82, 95% CI, 0.70-0.94). There were no significant differences between these 2 swallow types for peak frequency, duration, and peak amplitude. Our pilot study has shown that certain characteristics of swallow obtained using CA may be useful in the prediction of aspiration. However, further research comparing the acoustic swallowing sound profiles of normal children to children with dysphagia (who are aspirating) on a larger scale is required. © The Author(s) 2016.

  7. Setting a standard for electricity pilot studies

    International Nuclear Information System (INIS)

    Davis, Alexander L.; Krishnamurti, Tamar; Fischhoff, Baruch; Bruine de Bruin, Wandi

    2013-01-01

    In-home displays, dynamic pricing, and automated devices aim to reduce residential electricity use—overall and during peak hours. We present a meta-analysis of 32 studies of the impacts of these interventions, conducted in the US or Canada. We find that methodological problems are common in the design of these studies, leading to artificially inflated results relative to what one would expect if the interventions were implemented in the general population. Particular problems include having volunteer participants who may have been especially motivated to reduce their electricity use, letting participants choose their preferred intervention, and having high attrition rates. Using estimates of bias from medical clinical trials as a guide, we recalculate impact estimates to adjust for bias, resulting in values that are often less than half of those reported in the reviewed studies. We estimate that in-home displays were the most effective intervention for reducing overall electricity use (∼4% using reported data; ∼3% after adjusting for bias), while dynamic pricing significantly reduced peak demand (∼11% reported; ∼6% adjusted), especially when used in conjunction with home automation (∼25% reported; ∼14% adjusted). We conclude with recommendations that can improve pilot studies and the soundness of decisions based on their results. -- Highlights: •We conduct a meta-analysis of field studies of in-home displays, dynamic pricing, and automation on overall and peak use. •Studies were assessed and adjusted for risk-of-bias from inadequate experimental design. •Most studies were at high risk-of-bias from multiple sources. •In-home displays provided the best overall reduction in energy use, approximately 3% after adjustment for risk-of-bias. •Even after adjustment, automation approximately doubled the effectiveness of dynamic pricing on peak reduction from 6% to 14%

  8. The Citizenship Safety Project: a pilot study.

    Science.gov (United States)

    Frederick, K; Barlow, J

    2006-02-01

    The Government White Paper Saving Lives: Our Healthier Nation (1999) provides a clear indication that accidents are a serious public health problem and have been targeted by the Department of Health as a key area for prevention over the next 10 years. School-based injury prevention programmes have been identified as one of the key settings for the implementation of the White Paper's heath promotion strategies. The Citizen Safety Project (CSP) is a peer-delivered injury prevention programme for Year 10 students (14-15 years) and Year 2 pupils (6-7 years). This paper summarizes the findings of a pilot study that assessed the feasibility of implementing the CSP in schools and of conducting a larger study. Working as part of their Personal Social Health Education lessons, 11 pairs (n = 22) of Year 10 students developed a project to take one accident prevention theme of their choice into a primary school to teach small groups of five or six Year 2 pupils (n = 55). A formative evaluation was conducted, based on interviews with Year 2 and Year 10 teachers (n = 2), and the diaries of Year 10 students. Knowledge of accident prevention and risk awareness was measured in Year 2 pupils using the Draw and Write technique, and impact on Year 10 students was measured using self-esteem and locus of control inventories. Using both statistical and thematic analysis the study concludes that the CSP is well accepted, improves knowledge in Year 2 pupils and boosts confidence in Year 10 students, while concurrently achieving key stage attainment targets. Implications of the study are discussed in terms of future research, as are recommendations with regard to modifications to the project.

  9. Prehabilitation with Whey Protein Supplementation on Perioperative Functional Exercise Capacity in Patients Undergoing Colorectal Resection for Cancer: A Pilot Double-Blinded Randomized Placebo-Controlled Trial.

    Science.gov (United States)

    Gillis, Chelsia; Loiselle, Sarah-Eve; Fiore, Julio F; Awasthi, Rashami; Wykes, Linda; Liberman, A Sender; Stein, Barry; Charlebois, Patrick; Carli, Francesco

    2016-05-01

    A previous comprehensive prehabilitation program, providing nutrition counseling with whey protein supplementation, exercise, and psychological care, initiated 4 weeks before colorectal surgery for cancer, improved functional capacity before surgery and accelerated functional recovery. Those receiving standard of care deteriorated. The specific role of nutritional prehabilitation alone on functional recovery is unknown. This study was undertaken to estimate the impact of nutrition counseling with whey protein on preoperative functional walking capacity and recovery in patients undergoing colorectal resection for cancer. We conducted a double-blinded randomized controlled trial at a single university-affiliated tertiary center located in Montreal, Quebec, Canada. Colon cancer patients (n=48) awaiting elective surgery for nonmetastatic disease were randomized to receive either individualized nutrition counseling with whey protein supplementation to meet protein needs or individualized nutrition counseling with a nonnutritive placebo. Counseling and supplementation began 4 weeks before surgery and continued for 4 weeks after surgery. The primary outcome was change in functional walking capacity as measured with the 6-minute walk test. The distance was recorded at baseline, the day of surgery, and 4 weeks after surgery. A change of 20 m was considered clinically meaningful. The whey group experienced a mean improvement in functional walking capacity before surgery of +20.8 m, with a standard deviation of 42.6 m, and the placebo group improved by +1.2 (65.5) m (P=0.27). Four weeks after surgery, recovery rates were similar between groups (P=0.81). Clinically meaningful improvements in functional walking capacity were achieved before surgery with whey protein supplementation. These pilot results are encouraging and justify larger-scale trials to define the specific role of nutrition prehabilitation on functional recovery after surgery. Copyright © 2016 Academy of

  10. Multisite, randomized, double-blind, placebo-controlled pilot clinical trial to evaluate the efficacy of buspirone as a relapse-prevention treatment for cocaine dependence.

    Science.gov (United States)

    Winhusen, Theresa M; Kropp, Frankie; Lindblad, Robert; Douaihy, Antoine; Haynes, Louise; Hodgkins, Candace; Chartier, Karen; Kampman, Kyle M; Sharma, Gaurav; Lewis, Daniel F; VanVeldhuisen, Paul; Theobald, Jeff; May, Jeanine; Brigham, Gregory S

    2014-07-01

    To evaluate the potential efficacy of buspirone as a relapse-prevention treatment for cocaine dependence. A randomized, double-blind, placebo-controlled, 16-week pilot trial was conducted at 6 clinical sites between August 2012 and June 2013. Adult crack cocaine users meeting DSM-IV-TR criteria for current cocaine dependence who were scheduled to be in inpatient/residential substance use disorder (SUD) treatment for 12-19 days when randomized and planning to enroll in local outpatient treatment through the end of the active treatment phase were randomized to buspirone titrated to 60 mg/d (n = 35) or placebo (n = 27). All participants received psychosocial treatment as usually provided by the SUD treatment programs in which they were enrolled. Outcome measures included maximum days of continuous cocaine abstinence (primary), proportion of cocaine use days, and days to first cocaine use during the outpatient treatment phase (study weeks 4-15) as assessed by self-report and urine drug screens. There were no significant treatment effects on maximum continuous days of cocaine abstinence or days to first cocaine use. In the female participants (n = 23), there was a significant treatment-by-time interaction effect (χ²₁ = 15.26, P P = .70). The results suggest that buspirone is unlikely to have a beneficial effect on preventing relapse to cocaine use and that buspirone for cocaine-dependent women may worsen their cocaine use outcomes. ClinicalTrials.gov identifier: NCT01641159. © Copyright 2014 Physicians Postgraduate Press, Inc.

  11. 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.

  12. Blindness incidence in Germany. A population-based study from Württemberg-Hohenzollern.

    Science.gov (United States)

    Krumpaszky, H G; Lüdtke, R; Mickler, A; Klauss, V; Selbmann, H K

    1999-01-01

    Few data on the incidence of blindness in Germany are available. We analysed causes of legal blindness for the region Württemberg-Hohenzollern (population 5.5 million) in order to help fill in this gap. Population-based investigation on the incidence of legal blindness (visual acuity <1/50) based on materials from the social services. Age-dependent blindness incidences were modelled via logistic regression models. 647 blind persons were newly registered in 1994 (blindness incidence 11.6/100,000). The blindness incidence is moderate in infants (4.5/100,000) and decreases further during childhood. At the age of 20 years, the incidence again rises to the former level and remains relatively constant. After the age of 60 years, the incidence increases sharply: 5-year odds ratios are 1.76 (CI: 1.68-1. 85) in women and 1.72 (CI: 1.60-1.84) in men. The blindness incidence is higher in women, 15.6/100,000, compared to 12.2/100,000 in men. The major causes of blindness are: macular degeneration, 3. 92/100,000; diabetic retinopathy, 2.01/100,000; glaucoma, 1.6/100, 000; high myopia, 0.77/100,000; optic atrophy, 0.68/100,000; central nervous system-triggered blindness; 0.56/100,000, and tapetoretinal degenerations, 0.52/100,000. Due to monetary incentives for the blind persons, social service files offer accurate and complete data. Besides macular degeneration, glaucoma and diabetic retinopathy are major causes of blindness. Thus, this study suggests further blindness prevention activities for diabetic retinopathy and glaucoma.

  13. Cardiac Auscultation Using Smartphones: Pilot Study.

    Science.gov (United States)

    Kang, Si-Hyuck; Joe, Byunggill; Yoon, Yeonyee; Cho, Goo-Yeong; Shin, Insik; Suh, Jung-Won

    2018-02-28

    Cardiac auscultation is a cost-effective, noninvasive screening tool that can provide information about cardiovascular hemodynamics and disease. However, with advances in imaging and laboratory tests, the importance of cardiac auscultation is less appreciated in clinical practice. The widespread use of smartphones provides opportunities for nonmedical expert users to perform self-examination before hospital visits. The objective of our study was to assess the feasibility of cardiac auscultation using smartphones with no add-on devices for use at the prehospital stage. We performed a pilot study of patients with normal and pathologic heart sounds. Heart sounds were recorded on the skin of the chest wall using 3 smartphones: the Samsung Galaxy S5 and Galaxy S6, and the LG G3. Recorded heart sounds were processed and classified by a diagnostic algorithm using convolutional neural networks. We assessed diagnostic accuracy, as well as sensitivity, specificity, and predictive values. A total of 46 participants underwent heart sound recording. After audio file processing, 30 of 46 (65%) heart sounds were proven interpretable. Atrial fibrillation and diastolic murmur were significantly associated with failure to acquire interpretable heart sounds. The diagnostic algorithm classified the heart sounds into the correct category with high accuracy: Galaxy S5, 90% (95% CI 73%-98%); Galaxy S6, 87% (95% CI 69%-96%); and LG G3, 90% (95% CI 73%-98%). Sensitivity, specificity, positive predictive value, and negative predictive value were also acceptable for the 3 devices. Cardiac auscultation using smartphones was feasible. Discrimination using convolutional neural networks yielded high diagnostic accuracy. However, using the built-in microphones alone, the acquisition of reproducible and interpretable heart sounds was still a major challenge. ClinicalTrials.gov NCT03273803; https://clinicaltrials.gov/ct2/show/NCT03273803 (Archived by WebCite at http://www.webcitation.org/6x6g1fHIu).

  14. Acupuncture reduces crying in infants with infantile colic: a randomised, controlled, blind clinical study

    OpenAIRE

    Landgren, Kajsa; Kvorning, Nina; Hallstr?m, Inger

    2010-01-01

    Objective To investigate whether acupuncture reduces the duration and intensity of crying in infants with colic. Patients and methods 90 otherwise healthy infants, 2?8 weeks old, with infantile colic were randomised in this controlled blind study. 81 completed a structured programme consisting of six visits during 3 weeks to an acupuncture clinic in Sweden. Parents blinded to the allocation of their children met a blinded nurse. The infant was subsequently given to another nurse in a separate...

  15. Finding the FOO: A Pilot Study for a Multimodal Interface

    National Research Council Canada - National Science Library

    Perzanowski, Dennis; Brock, Derek; Adams, William; Bugajska, Magdalena; Schultz, Alan C; Trafton, J. G; Blisard, Sam; Skubic, Majorie

    2003-01-01

    .... As a preliminary step to evaluate their approach and to identify practical areas for future work, they conducted a Wizard-of-Oz pilot study with five participants who each collaborated with a robot...

  16. Pilot study for assessment of prevalence of intrafamilial hepatitis C ...

    African Journals Online (AJOL)

    Pilot study for assessment of prevalence of intrafamilial hepatitis C transmission in relation to salivary viral load among infected patients with and without chronic renal failure. H El Tayeb, NA El Nakeeb, MM Sayed, WA Yousry, SHA Agwa ...

  17. Iopamidol vs Metrizamide: a double blind study for cervical myelography

    Energy Technology Data Exchange (ETDEWEB)

    Drayer, P.; Warner, M.A.; Allen, S.; Bates, M.; Sudilovsky, A.; Luther, J.; Wilkins, R.

    1982-11-01

    A double-blind study was performed on 20 patients comparing the safety and efficacy of Iopamidol and Metrizamide in cervical myelography. The radiographic qualities of the Iopamidol and Metrizamide examinations were equivalent when using the same volume (12 to 13 ml), concentration (200 mg I/ml) and a C1-2 route of administration. The performance of a CT scan on selected patients in specified areas of interest provided additional diagnostic information in some patients (e.g. syringomyelia, degenerative spondylosis). The adverse reactions were mild in the Iopamidol group with 4 of the 10 patients experiencing no adverse reactions. The more severe reactions, including disorientation, agitation, dysarthria, asterixis, hyperreflexia and EEG abnormalities were limited to the Metrizamide group with one or more occurring in 2 of the 10 patients studies. Only one Metrizamide patient experienced no adverse reactions. In this study containing a limited number of patients, Iopamidol was shown to be a diagnostically effective and safer contrast medium for performing cervical myelography.

  18. Effects of long-term treatment with oxytocin in chronic constipation; a double blind, placebo-controlled pilot trial.

    Science.gov (United States)

    Ohlsson, B; Truedsson, M; Bengtsson, M; Torstenson, R; Sjölund, K; Björnsson, E S; Simrèn, M

    2005-10-01

    Oxytocin and its receptor have been found throughout the gastrointestinal (GI) tract, where it affects gut function. Clinically, we have noticed an improvement of bowel habits during lactation in constipated women. The aim of this study was to examine whether oxytocin has an effect on bowel symptoms and psychological well being in women with refractory constipation. Fifty-nine women with refractory constipation were included in a double blind, multicentre study. After a 2-week run-in period, they were randomly allocated to nasal inhalation of either placebo or oxytocin treatment twice daily for 13 weeks, followed by a 2 weeks, posttreatment period. The patients completed a questionnaire every day concerning bowel habits, abdominal pain and discomfort, and Gastrointestinal Symptoms Rating Scale (GSRS) and Psychological General Well-being (PGWB) twice during the study; namely, during the baseline period and at the end of the treatment period. Both oxytocin and placebo led to improvement of the constipation according to the GSRS and led to improvement in the sensation of incomplete evacuation and anorectal obstruction, without significant differences between the groups. Abdominal pain and discomfort responded weakly to oxytocin, with no effect of the placebo. In a subgroup of patients with IBS and concomitant depression, a weak improvement in depressed mood was observed after oxytocin administartion. Nasal administration of oxytocin had no significant advantage over placebo concerning an effect on constipation. However, it seems to have a positive effect on abdominal pain and discomfort and depressed mood. These findings should be further explored.

  19. LAM Pilot Study with Imatinib Mesylate (LAMP-1)

    Science.gov (United States)

    2015-10-01

    AD______________ AWARD NUMBER: W81XWH-14-1-0132 TITLE: LAM Pilot Study with Imatinib Mesylate (LAMP-1) PRINCIPAL INVESTIGATOR: Charlie...AND SUBTITLE LAM Pilot Study with Imatinib Mesylate (LAMP-1) 5a. CONTRACT NUMBER 5b. GRANT NUMBER W81XWH-14-1-0132 5c. PROGRAM ELEMENT...designed to generate short-term safety and efficacy data regarding imatinib mesylate ( imatinib ) in the treatment of Lymphangioleiomyomatosis (LAM

  20. The effect of low-level laser therapy on orthodontically induced root resorption: a pilot double blind randomized controlled trial.

    Science.gov (United States)

    Ng, Doreen; Chan, Ambrose K; Papadopoulou, Alexandra K; Dalci, Oyku; Petocz, Peter; Darendeliler, Mehmet Ali

    2017-09-07

    The effect of low-level laser therapy (LLLT) on accelerating orthodontic tooth movement has been extensively studied; however, there is limited knowledge on the use of LLLT on orthodontic root resorption. To investigate the effect of LLLT on orthodontically induced inflammatory root resorption (OIIRR) and to compare the difference between pulsed and continuous LLLT on OIIRR. Double-blind, single-centre 3-arm parallel split-mouth randomized controlled trial. Twenty adolescent patients who required bilateral maxillary first premolar (MFP) orthodontic extractions were recruited from the Sydney Dental Hospital between October 2014 and December 2014. All MFPs were tipped buccally for 28 days to induce OIIRR. The experimental premolars (n = 20) received LLLT and the control premolars (n = 20) received placebo-laser on days 0, 1, 2, 3, 7, 14, and 21. Ten experimental premolars received LLLT via continuous delivery and 10 received pulsed delivery. AlGaAs diode laser of 808 nm wavelength, 0.18 W power, 1.6 J per point, and duration of 9s for continuous mode and 4.5 s for pulsed mode. The difference in root resorption crater volume between LLLT and placebo-laser and continuous or pulsed laser delivery after 28 days. Randomization was computer-generated, with allocation concealment by opaque sequentially numbered sealed envelopes. The participants and operator were blinded. Eighty-eight patients were screened and 20 patients were randomized. Forty premolars were analysed. LLLT resulted in 23 per cent less root resorption compared to the placebo (P = 0.026). Pulsed laser delivery resulted in 5 per cent less root resorption than continuous; however, this was not statistically significant (P = 0.823). No harm was observed. Teeth treated with LLLT had less total root resorption than placebo-laser. Furthermore, there was minimal difference between pulsed or continuous delivery of LLLT. Clinical Trials Registry (ACTRN12616000829415). The protocol was not published before trial

  1. Are headache and temporomandibular disorders related? A blinded study.

    Science.gov (United States)

    Ballegaard, V; Thede-Schmidt-Hansen, P; Svensson, P; Jensen, R

    2008-08-01

    To investigate overlaps between headache and temporomandibular disorders (TMD) in a clinical headache population and to describe the prevalence of TMD in headache patients, 99 patients referred to a specialized headache centre were diagnosed according to Research Diagnostic Criteria for TMD (RDC/TMD) and classified in headache groups according to the International Classification of Headache Disorders, second edition for headache diagnoses in a blinded design. The prevalence of TMD in the headache population was 56.1%. Psychosocial dysfunction caused by TMD pain was observed in 40.4%. No significant differences in TMD prevalence were revealed between headache groups, although TMD prevalence tended to be higher in patients with combined migraine and tension-type headache. Moderate to severe depression was experienced by 54.5% of patients. Patients with coexistent TMD had a significantly higher prevalence of depression-most markedly in patients with combined migraine and tension-type headache. Our studies indicate that a high proportion of headache patients have significant disability because of ongoing chronic TMD pain. The trend to a higher prevalence of TMD in patients with combined migraine and tension-type headache suggests that this could be a risk factor for TMD development. A need for screening procedures and treatment strategies concerning depression in headache patients with coexistent TMD is underlined by the overrepresentation of depression in this group. Our findings emphasize the importance of examination of the masticatory system in headache sufferers and underline the necessity of a multidimensional approach in chronic headache patients.

  2. SUPERFUND TREATABILITY CLEARINGHOUSE: SOIL STABILIZATION PILOT STUDY, UNITED CHROME NPL SITE PILOT STUDY AND HEALTH AND SAFETY PROGRAM, UNITED CHROME NPL SITE PILOT STUDY

    Science.gov (United States)

    This document is a project plan for a pilot study at the United Chrome NPL site, Corvallis, Oregon and includes the health and safety and quality assurance/quality control plans. The plan reports results of a bench-scale study of the treatment process as iieasured by the ...

  3. 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.

  4. Nationwide incidence of blindness in South Korea: a 12-year study from 2002 to 2013.

    Science.gov (United States)

    Rim, Tyler Hyungtaek; Kim, Dong Wook; Chung, Eun Jee; Kim, Sung Soo

    2017-11-01

    Blindness is an important public health issue. The background of the study is to determine the incidence of blindness in South Korea. Nationwide population-based retrospective study. All individuals from South Korea (n = 47 516 098). Patients confirmed with legal blindness based on the worse-seeing and better-seeing eyes between 1 January 2002 and 31 December 2013 were included. The Korean National Health Insurance Service (KNHIS) database was used. Using the World Health Organization definition, blindness was defined as best-corrected visual acuity in the worse-seeing and better-seeing eyes of South Korea was estimated using census data in 2005 and 2010. The total number of legal blindness cases in the KNHIS database. We identified 195 004 and 20 492 cases of newly developed legal blindness based on the worse-seeing and better-seeing eyes, respectively, and the mean incidences of blindness were 34.2 and 3.6 cases/100 000 person-years, respectively. The prevalence of blindness based on the worse-seeing and better-seeing eyes was 425.3 and 57.7 cases/100 000 persons, respectively. The incidence of blindness based on the worse-seeing eye was higher in men than in women overall. Additionally, the incidence increased with age and showed a decreasing trend from 2002 to 2013. The prevalence of blindness showed an increasing trend from 2002 to 2013. The findings of our study will help in the assessment of the blindness-related socio-economic burden and in healthcare planning. © 2017 Royal Australian and New Zealand College of Ophthalmologists.

  5. Echolocation: A Study of Auditory Functioning in Blind and Sighted Subjects.

    Science.gov (United States)

    Arias, C.; And Others

    1993-01-01

    This study evaluated the peripheral and central auditory functioning (and thus the potential to perceive obstacles through reflected sound) of eight totally blind persons and eight sighted persons. The blind subjects were able to process auditory information faster than the control group. (Author/DB)

  6. [Cortical blindness].

    Science.gov (United States)

    Chokron, S

    2014-02-01

    Cortical blindness refers to a visual loss induced by a bilateral occipital lesion. The very strong cooperation between psychophysics, cognitive psychology, neurophysiology and neuropsychology these latter twenty years as well as recent progress in cerebral imagery have led to a better understanding of neurovisual deficits, such as cortical blindness. It thus becomes possible now to propose an earlier diagnosis of cortical blindness as well as new perspectives for rehabilitation in children as well as in adults. On the other hand, studying complex neurovisual deficits, such as cortical blindness is a way to infer normal functioning of the visual system. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

  7. Effect of valsartan on systemic right ventricular function: a double-blind, randomized, placebo-controlled pilot trial

    NARCIS (Netherlands)

    van der Bom, Teun; Winter, Michiel M.; Bouma, Berto J.; Groenink, Maarten; Vliegen, Hubert W.; Pieper, Petronella G.; van Dijk, Arie P. J.; Sieswerda, Gertjan T.; Roos-Hesselink, Jolien W.; Zwinderman, Aeilko H.; Mulder, Barbara J. M.

    2013-01-01

    The role of angiotensin II receptor blockers in patients with a systemic right ventricle has not been elucidated. We conducted a multicenter, double-blind, parallel, randomized controlled trial of angiotensin II receptor blocker valsartan 160 mg twice daily compared with placebo in patients with a

  8. Effect of Valsartan on Systemic Right Ventricular Function A Double-Blind, Randomized, Placebo-Controlled Pilot Trial

    NARCIS (Netherlands)

    van der Bom, Teun; Winter, Michiel M.; Bouma, Berto J.; Groenink, Maarten; Vliegen, Hubert W.; Pieper, Petronella G.; van Dijk, Arie P. J.; Sieswerda, Gertjan T.; Roos-Hesselink, Jolien W.; Zwinderman, Aeilko H.; Mulder, Barbara J. M.

    2013-01-01

    Background-The role of angiotensin II receptor blockers in patients with a systemic right ventricle has not been elucidated. Methods and Results-We conducted a multicenter, double-blind, parallel, randomized controlled trial of angiotensin II receptor blocker valsartan 160 mg twice daily compared

  9. Johrei Family Healing: A Pilot Study

    Directory of Open Access Journals (Sweden)

    P. H. Canter

    2006-01-01

    Full Text Available Johrei is a form of spiritual healing comprising “energy channelling” and light massage given either by a trained healer or, after some basic training, by anyone. This pilot trial aimed to identify any potential benefits of family-based Johrei practice in childhood eczema and for general health and to establish the feasibility of a subsequent randomised controlled trial. Volunteer families of 3-5 individuals, including at least one child with eczema were recruited to an uncontrolled pilot trial lasting 12 months. Parents were trained in Johrei healing and then practised at home with their family. Participants kept diaries and provided questionnaire data at baseline, 3,6 and 12 months. Eczema symptoms were scored at the same intervals. Scepticism about Johrei is presently an obstacle to recruitment and retention of a representative sample in a clinical trial, and to its potential use in general practice. The frequency and quality of practise at home by families may be insufficient to bring about the putative health benefits. Initial improvements in eczema symptoms and diary recorded illness, could not be separated from seasonal factors and other potential confounders. There were no improvements on other outcomes measuring general health and psychological wellbeing of family members.

  10. Johrei family healing: a pilot study.

    Science.gov (United States)

    Canter, P H; Brown, L B; Greaves, C; Ernst, E

    2006-12-01

    Johrei is a form of spiritual healing comprising "energy channelling" and light massage given either by a trained healer or, after some basic training, by anyone. This pilot trial aimed to identify any potential benefits of family-based Johrei practice in childhood eczema and for general health and to establish the feasibility of a subsequent randomised controlled trial. Volunteer families of 3-5 individuals, including at least one child with eczema were recruited to an uncontrolled pilot trial lasting 12 months. Parents were trained in Johrei healing and then practised at home with their family. Participants kept diaries and provided questionnaire data at baseline, 3,6 and 12 months. Eczema symptoms were scored at the same intervals. Scepticism about Johrei is presently an obstacle to recruitment and retention of a representative sample in a clinical trial, and to its potential use in general practice. The frequency and quality of practise at home by families may be insufficient to bring about the putative health benefits. Initial improvements in eczema symptoms and diary recorded illness, could not be separated from seasonal factors and other potential confounders. There were no improvements on other outcomes measuring general health and psychological wellbeing of family members.

  11. Aspartame sensitivity? A double blind randomised crossover study.

    Directory of Open Access Journals (Sweden)

    Thozhukat Sathyapalan

    Full Text Available Aspartame is a commonly used intense artificial sweetener, being approximately 200 times sweeter than sucrose. There have been concerns over aspartame since approval in the 1980s including a large anecdotal database reporting severe symptoms. The objective of this study was to compare the acute symptom effects of aspartame to a control preparation.This was a double-blind randomized cross over study conducted in a clinical research unit in United Kingdom. Forty-eight individual who has self reported sensitivity to aspartame were compared to 48 age and gender matched aspartame non-sensitive individuals. They were given aspartame (100mg-containing or control snack bars randomly at least 7 days apart. The main outcome measures were acute effects of aspartame measured using repeated ratings of 14 symptoms, biochemistry and metabonomics.Aspartame sensitive and non-sensitive participants differed psychologically at baseline in handling feelings and perceived stress. Sensitive participants had higher triglycerides (2.05 ± 1.44 vs. 1.26 ± 0.84mmol/L; p value 0.008 and lower HDL-C (1.16 ± 0.34 vs. 1.35 ± 0.54 mmol/L; p value 0.04, reflected in 1H NMR serum analysis that showed differences in the baseline lipid content between the two groups. Urine metabonomic studies showed no significant differences. None of the rated symptoms differed between aspartame and control bars, or between sensitive and control participants. However, aspartame sensitive participants rated more symptoms particularly in the first test session, whether this was placebo or control. Aspartame and control bars affected GLP-1, GIP, tyrosine and phenylalanine levels equally in both aspartame sensitive and non-sensitive subjects.Using a comprehensive battery of psychological tests, biochemistry and state of the art metabonomics there was no evidence of any acute adverse responses to aspartame. This independent study gives reassurance to both regulatory bodies and the public that

  12. THE EFFECT OF THERMAL ENVIRONMENT ON LEARNING, A PILOT STUDY.

    Science.gov (United States)

    PECCOLO, CHARLES

    THIS IS A REPORT OF A FIRST PILOT STUDY WHICH PRECEDES A SERIES OF STUDIES BEING CONDUCTED BY THE IOWA CENTER FOR RESEARCH IN SCHOOL ADMINISTRATION AND LENNOX INDUSTRIES INC., MARSHALLTOWN, IOWA. IT IS A DIGEST OF A THESIS BY DR. CHARLES PECCOLO WHO SERVED AS RESEARCHER ON THIS FIRST STUDY. THE STUDY AIMED AT MEASURING THE EFFECTS OF THERMAL…

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

    Science.gov (United States)

    Koley, Munmun; Saha, Subhranil; Ghosh, Shubhamoy

    2015-07-01

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

  14. 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.

  15. Pilot study approach and qualification dossier components

    International Nuclear Information System (INIS)

    Ammirato, F.; Ashwin, P.

    2000-01-01

    The aim of the Pilot Project is to evaluate the IAEA Guidelines and methodology for the benefit of IAEA Member States trough a simulation of qualification activities. The Project is based on a real component and available data - NPP Kozloduy unit 5, weld 3. The initial phase is limited to the Qualification dossier. The Project relies on the input from the team members and Member States. Team organization and responsibilities are presented. The components of the Qualification Dossier (technical specification, inspection procedure and preliminary review, qualification procedure) and their current status are also presented. A comparison is done with their qualification programs. The characteristics of performance demonstrations are discussed. The results show that the teamwork has been successful and the IAEA methodology covers all situations. It is expected that the End Project will become 'Benchmark's' for future qualification activities

  16. Dehydration Impairs Cycling Performance, Independently of Thirst: A Blinded Study.

    Science.gov (United States)

    Adams, J D; Sekiguchi, Yasuki; Suh, Hyun-Gyu; Seal, Adam D; Sprong, Cameron A; Kirkland, Tracie W; Kavouras, Stavros A

    2018-03-05

    The aim of the present study was to examine the effect of dehydration on exercise performance independently of thirst with subjects blinded of their hydration status. Seven male cyclists (weight: 72±9 kg, body fat: 14±6%, VO2peak: 59.4±6 ml[BULLET OPERATOR]kg·min) exercised for 2 hours on a cycle ergometer at 55% VO2peak, in a hot-dry environment (35°C, 30% rh), with a nasogastric (NG) tube under euhydrated - non-thirst (EUH-NT) and dehydrated - non-thirst (DEH-NT) conditions. In both trials, thirst was matched by drinking 25 mL of water every 5-min (300 mL[BULLET OPERATOR]h). In the EUH-NT trial sweat losses were fully replaced by water via the NG tube (calculated from the familiarization trial). Following the 2-h of steady state, the subjects completed a 5-km cycling time trial at 4% grade. Body mass loss for the EUH-NT and DEH-NT after the 2-h was -0.2±0.6 and -2.2±0.4%, while after the 5-km time trial was -0.7±0.5 and 2.9±0.4%, respectively. Thirst (35±30 vs. 42±31 mm) and stomach fullness (46±21 vs. 35±20 mm) did not differ at the end of the 2-h of steady state between EUH-NT and DEH-NT trials (P>0.05). Subjects cycled faster during the 5-km time trial in the EUH-NT trial compared to the DEH-NT trial (23.2±1.5 vs. 22.3±1.8 km·h, P0.05). These data indicated that hypohydration decreased cycling performance and impaired thermoregulation independently of thirst, while the subjects were unaware of their hydration status.

  17. Evaluation of efficacy of metoprolol in patients having heart failure with preserved ejection fraction: A randomized, double-blind, placebo-controlled pilot trial

    Directory of Open Access Journals (Sweden)

    Niti Mittal

    2017-01-01

    Conclusion: Hence, this pilot study showed that metoprolol succinate possibly has some beneficial role in HFpEF as reflected by improvement in some parameters. The findings highlight the need of a larger study with longer follow-up to provide a definitive answer.

  18. Pilot study on the European Portuguese version of the Confusion Assessment Method.

    Science.gov (United States)

    Martins, Sónia; Moldes, Patrícia; Pinto-de-Sousa, João; Conceição, Filipe; Paiva, José Artur; Simões, Mário R; Fernandes, Lia

    2014-10-01

    To present the pilot study on the European Portuguese validation of the Confusion Assessment Method (CAM). The translation process was carried out according to International Society Pharmacoeconomics and Outcomes Research guidelines with trained researchers and inter-rater reliability assessment. The study included 50 elderly patients, admitted (≥24 h) to two intermediate care units. Exclusion criteria were: Glasgow Coma Scale (total score ≤11), blindness/deafness, inability to communicate and not able to speak Portuguese. The sensitivity and specificity of CAM were assessed, with DSM-IV-TR criteria of delirium used as a reference standard. Findings revealed excellent inter-rater reliability (k>0.81), moderate sensitivity (73%) and excellent specificity (95%). These preliminary results suggested that this version emerges as a promising diagnostic instrument for delirium.

  19. Evaluating midwifery units (EMU): lessons from the pilot study.

    Science.gov (United States)

    Monk, Amy R; Tracy, Sally K; Foureur, Maralyn; Tracy, Mark

    2013-08-01

    this paper describes the pilot study that was undertaken to test the feasibility of the recruitment plan designed to recruit women who booked to give birth in two freestanding midwifery units in NSW, Australia. The pilot preceded the full prospective cohort study, Evaluating Midwifery Units (EMU), which aimed to examine the antenatal, birth and postnatal outcomes of women planning to give birth in freestanding midwifery units compared to those booked to give birth in tertiary level maternity units in Australia and New Zealand. a prospective cohort study with two mutually-exclusive cohorts. two freestanding midwifery units in NSW and their corresponding tertiary referral hospitals. a total of 146 women with few identified risk factors recruited between 13 September 2009 and 31 March 2010 whose planned place of birth was either a freestanding midwifery unit or tertiary maternity unit. the pilot study identified the feasibility of relying on the booking midwife to recruit eligible women from several antenatal booking clinics to the study. Low rates of eligible women were invited resulting in a lower than expected consent rate. In addition, although mostly only low-risk women were invited to participate, some women requiring medical consultation at the time of booking were inadvertently recruited into the study. The results of this pilot study led us to revise the study protocol to find ways of including the outcomes of all women without identified risk factors who booked at either the freestanding midwifery units or the tertiary referral hospital in that area. This paper describes the revisions that were made to the study plan. five lessons were learned from the pilot study. We found that recruitment protocols employed for the cohort study were too complicated and required simplification to maximise the potential of the study. The study protocol needed to be changed for the main study to ensure a larger sample size and to ensure the risk profile of each cohort was as

  20. NIH Study Provides Clarity on Supplements for Protection Against Blinding Eye Disease

    Science.gov (United States)

    ... May 5, 2013 NIH study provides clarity on supplements for protection against blinding eye disease Adding omega- ... acids did not improve a combination of nutritional supplements commonly recommended for treating age-related macular degeneration ( ...

  1. A Canadian multicenter, double-blind study of paroxetine and fluoxetine in major depressive disorder

    NARCIS (Netherlands)

    Chouinard, G; Saxena, B; Belanger, MC; Ravindran, A; Bakish, D; Beauclair, L; Morris, P; Nair, NPV; Manchanda, R; Reesal, R; Remick, R; O'Neill, MC

    Background: Recent studies have suggested clinical differences among selective serotonin reuptake inhibitors. In a 12-week randomized, multicenter, double-blind trial, the antidepressant and anxiolytic efficacy of the selective serotonin reuptake inhibitors paroxetine and fluoxetine was compared in

  2. Are You an Online Team Player? A Pilot Study

    Science.gov (United States)

    Rawlings, Melody

    2014-01-01

    The purpose of this pilot case study was to answer the following research questions: How do previous experiences affect students' attitudes toward online teamwork? When do students' attitudes toward online teamwork first develop and why? Using a social constructivist framework, a qualitative case study design was utilized to conduct an online…

  3. Self moving patients to the operation theatre - a pilot study

    DEFF Research Database (Denmark)

    Qvarfordh, Anna Pernilla; Rovsing, Marie Louise; Esbensen, Bente Appel

    2010-01-01

    The purpose of this pilot study was to investigate patients' satisfaction with walking to the operation theatre instead of being driven in a bed or wheel chair, and to identify the need for information. In total, 75 patients (aged 15-83 years) participated in the study. A questionnaire was develo...... access to the operation theatre....

  4. Behavioral Activation for Depressed Teens: A Pilot Study

    Science.gov (United States)

    Ritschel, Lorie A.; Ramirez, Cynthia L.; Jones, Meredith; Craighead, W. Edward

    2011-01-01

    Behavioral activation (BA) is a psychosocial intervention that has shown promising treatment outcome results with depressed adults. The current pilot study evaluated a version of BA adapted for depressed adolescents. Six teens (3 male, 3 female, ages 14-17) who met criteria for major depressive disorder participated in the study. Participants were…

  5. Attitudes Toward Guarani and Spanish: A Pilot Study in Paraguay.

    Science.gov (United States)

    Rhodes, Nancy C.

    This study analyzes the language attitudes of the Paraguayan people toward their two languages, Guarani and Spanish. To study the bilingual situation in the South American country, a pilot survey was carried out in the capital city addressing the major topics of language attitudes, language usage, and language varieties. The goals of the survey…

  6. Glaucoma blind registration in Fife (2000-2009) - a retrospective cohort study.

    Science.gov (United States)

    O'Colmain, Una; Anijeet, Deepa; Vosoughi, Marcus; Sinclair, Anne; Sanders, Roshini

    2011-07-01

    To collate information on patients registered blind secondary to glaucoma between 2000 and 2009 and compare findings to an identical study completed a decade earlier between 1990 and 1999. The records of all people registered as blind via the Fife Society for the Blind between 2000 and 2009 were retrospectively examined and those with glaucoma as the primary cause were studied in detail. We compared these results with the results of our previous study, in which we examined the same documents for the preceding decade, 1990-1999. The glaucoma blind registration rate was reduced by 31% in the current study compared to the previous one (60 vs 87 patients, p = 0.013). At the same time, there was a 6% increase in blindness registrations due to all causes (881 vs 938, p = 0.62). Patients were referred with significantly fewer visual symptoms (33% vs 60%, p = 0.002) and glaucoma surgery rates increased from 44% to 62% in the current study (p = 0.013). In the later decade, more patients were offered partial sight registration before blind registration (37% vs 10%, p blind registration in this study (66% vs 33%, p cognitive impairment and/or hearing loss and this was similar to the first study.   The study demonstrates a downward trend in the rates of blind registration due to glaucoma, compared to stable rates of registration for all diseases. Over the time period of the two studies there were refinements in the way glaucoma is managed medically by the hospital eye service and in the community, with a high level of input maintained from the local low vision service. Ophthalmic & Physiological Optics © 2011 The College of Optometrists.

  7. Aesthetics of movement with sight disabled children - pilot study

    Directory of Open Access Journals (Sweden)

    Mirosław Górny

    2010-01-01

    Full Text Available The aim of the study was to establish the aesthetics of movement in people with vision defects. This knowledge will provide tools to improve the methodology of study in the area of assessment of movement aesthetics in people with disabilities. In order to establish its level a test was used which measured its selected elements such as precision, rhythm, harmony, fluidity and speed. The aesthetics of movement was assessed using exercise tests which were to represent the components of aesthetics of movement. Individual tests were carried out on blind and partially sighted children aged 6 to 15 years and on a group of healthy children of the same age. Using the test tasks a general indicator of movement aesthetics in blind children was obtained. The participants of the study were 145 children from four School and Education Centres for Blind Children in Poland and the control group consisted of 310 children from a primary school in Poznań. The studies confirmed a lower level of movement aesthetics in children with vision defects, but the differences in groups between the partially sighted children and children with correct vision were definitely smaller. A higher level of aesthetics of movement characterised children from older groups irrespective of their sex. The best developed property in blind and partially sighted children was precision.

  8. Are headache and temporomandibular disorders related? A blinded study

    DEFF Research Database (Denmark)

    Ballegaard, V.; Thede-Schmidt-Hansen, P.; Svensson, P.

    2008-01-01

    To investigate overlaps between headache and temporomandibular disorders (TMD) in a clinical headache population and to describe the prevalence of TMD in headache patients, 99 patients referred to a specialized headache centre were diagnosed according to Research Diagnostic Criteria for TMD (RDC....../TMD) and classified in headache groups according to the International Classification of Headache Disorders, second edition for headache diagnoses in a blinded design. The prevalence of TMD in the headache population was 56.1%. Psychosocial dysfunction caused by TMD pain was observed in 40.4%. No significant...

  9. Clinical trials with nested subgroups: Analysis, sample size determination and internal pilot studies.

    Science.gov (United States)

    Placzek, Marius; Friede, Tim

    2017-01-01

    The importance of subgroup analyses has been increasing due to a growing interest in personalized medicine and targeted therapies. Considering designs with multiple nested subgroups and a continuous endpoint, we develop methods for the analysis and sample size determination. First, we consider the joint distribution of standardized test statistics that correspond to each (sub)population. We derive multivariate exact distributions where possible, providing approximations otherwise. Based on these results, we present sample size calculation procedures. Uncertainties about nuisance parameters which are needed for sample size calculations make the study prone to misspecifications. We discuss how a sample size review can be performed in order to make the study more robust. To this end, we implement an internal pilot study design where the variances and prevalences of the subgroups are reestimated in a blinded fashion and the sample size is recalculated accordingly. Simulations show that the procedures presented here do not inflate the type I error significantly and maintain the prespecified power as long as the sample size of the smallest subgroup is not too small. We pay special attention to the case of small sample sizes and attain a lower boundary for the size of the internal pilot study.

  10. A comparative study of simple auditory reaction time in blind (congenitally) and sighted subjects.

    Science.gov (United States)

    Gandhi, Pritesh Hariprasad; Gokhale, Pradnya A; Mehta, H B; Shah, C J

    2013-07-01

    Reaction time is the time interval between the application of a stimulus and the appearance of appropriate voluntary response by a subject. It involves stimulus processing, decision making, and response programming. Reaction time study has been popular due to their implication in sports physiology. Reaction time has been widely studied as its practical implications may be of great consequence e.g., a slower than normal reaction time while driving can have grave results. To study simple auditory reaction time in congenitally blind subjects and in age sex matched sighted subjects. To compare the simple auditory reaction time between congenitally blind subjects and healthy control subjects. STUDY HAD BEEN CARRIED OUT IN TWO GROUPS: The 1(st) of 50 congenitally blind subjects and 2(nd) group comprises of 50 healthy controls. It was carried out on Multiple Choice Reaction Time Apparatus, Inco Ambala Ltd. (Accuracy±0.001 s) in a sitting position at Government Medical College and Hospital, Bhavnagar and at a Blind School, PNR campus, Bhavnagar, Gujarat, India. Simple auditory reaction time response with four different type of sound (horn, bell, ring, and whistle) was recorded in both groups. According to our study, there is no significant different in reaction time between congenital blind and normal healthy persons. Blind individuals commonly utilize tactual and auditory cues for information and orientation and they reliance on touch and audition, together with more practice in using these modalities to guide behavior, is often reflected in better performance of blind relative to sighted participants in tactile or auditory discrimination tasks, but there is not any difference in reaction time between congenitally blind and sighted people.

  11. Assessing the Flipped Classroom in Operations Management: A Pilot Study

    Science.gov (United States)

    Prashar, Anupama

    2015-01-01

    The author delved into the results of a flipped classroom pilot conducted for an operations management course module. It assessed students' perception of a flipped learning environment after making them experience it in real time. The classroom environment was construed using a case research approach and students' perceptions were studied using…

  12. Critical Thinking in Nurse Anesthesia Education: A Pilot Study

    Science.gov (United States)

    Burns, Shari; Mendel, Shaun; Fisher, Rodney; Cooper, Kimball; Fisher, Michael

    2013-01-01

    Critical thinking is pivotal for student success in health professions education. Knowing the critical thinking ability of the learner helps educators tailor curriculum to enhance critical thinking. A quantitative comparative pilot study assessed critical thinking ability for students at two distinct points in a nurse anesthesia program…

  13. Biomagnetic Pair Therapy and Typhoid Fever: A Pilot Study

    OpenAIRE

    Frank, Bryan L.

    2017-01-01

    Objective: This pilot study examined the laboratory responses of patients with laboratory-documented typhoid fever who were treated with Biomagnetic Pair Therapy (BPT; medical biomagnetism), a specific application of pairs of magnets for various ailments that are infectious and otherwise.

  14. Nutrition education program for food bank clients: A pilot study

    Science.gov (United States)

    Many low income families depend on foods from food banks. The objective of the study was to determine program content and examine feasibility of a pilot nutrition education program for food bank clients. Formative research was conducted with staff at a local food bank and its pantries and adult clie...

  15. Outcome evaluation of a pilot study using "nudges"

    Science.gov (United States)

    Every school day, over 31 million U.S. children eat school lunches. Unfortunately, students often do not choose the healthy options in the school cafeteria. This paper describes outcome results of a pilot study using "nudges" to improve elementary school students' fruits and vegetables selections. A...

  16. The Effect of Background Music on Bullying: A Pilot Study

    Science.gov (United States)

    Ziv, Naomi; Dolev, Einat

    2013-01-01

    School bullying is a source of growing concern. A number of intervention programs emphasize the importance of a positive school climate in preventing bullying behavior. The aim of the presented pilot study was to examine whether calming background music, through its effect on arousal and mood, could create a pleasant atmosphere and reduce bullying…

  17. Classifying patients' complaints for regulatory purposes : A Pilot Study

    NARCIS (Netherlands)

    Bouwman, R.J.R.; Bomhoff, Manja; Robben, Paul; Friele, R.D.

    2018-01-01

    Objectives: It is assumed that classifying and aggregated reporting of patients' complaints by regulators helps to identify problem areas, to respond better to patients and increase public accountability. This pilot study addresses what a classification of complaints in a regulatory setting

  18. Emission studies from a CO2 capture pilot plant

    NARCIS (Netherlands)

    Silva, E.F. da; Kolderup, H.; Goetheer, E.L.V.; Hjarbo, K.W.; Huizinga, A.; Khakharia, P.M.; Tuinman, I.L.; Mejdell, T.; Zahlsen, K.; Vernstad, K.; Hyldbakk, A.; Holten, T.; Kvamsdal, H.M.; Os, P.J. van; Einbu, A.

    2013-01-01

    We report on a detailed study of emissions from a pilot-plant for CO2 capture at Maasvlakte (in the Netherlands). Three contributions to emissions were identified and analyzed: Gas phase emission, aerosols (also referred to as mist or fog) and droplets of entrained solvents. For the emission

  19. Can Markers Detect Contract Cheating? Results from a Pilot Study

    Science.gov (United States)

    Dawson, Phillip; Sutherland-Smith, Wendy

    2018-01-01

    Contract cheating is the purchasing of custom-made university assignments with the intention of submitting them. Websites providing contract cheating services often claim this form of cheating is undetectable, and no published research has examined this claim. This paper documents a pilot study where markers were paid to mark a mixture of real…

  20. Physical activity in Georgia state parks: A pilot study

    Science.gov (United States)

    Lincoln R. Larson; Jason W. Whiting; Gary T. Green

    2012-01-01

    This pilot study assessed the role of Georgia State Parks in the promotion of physical activity among different racial/ethnic and age groups. Data were collected at three state parks in north Georgia during the summer of 2009 using two research methods: behavior observations (N=2281) and intercept surveys (N=473).

  1. Effects of aquajogging in obese adults: a pilot study

    NARCIS (Netherlands)

    PhD Ronette Kolotkin; MSc Annemieke van Nunen; PhD Rinie Geenen; PhD Ad Vingerhoets; MD E.J.M. Wouters

    2009-01-01

    Aim and method: To examine in obese people the potential effectiveness of a six-week, two times weekly aquajogging program on body composition, fitness, health-related quality of life and exercise beliefs. Fifteen otherwise healthy obese persons participated in a pilot study. Results: Total fat mass

  2. Effects of aquajogging in obese adults : A pilot study

    NARCIS (Netherlands)

    Wouters, E.J.M.; van Nunen, A.M.A.; Geenen, R.; Kolotkin, R.L.; Vingerhoets, A.J.J.M.

    2010-01-01

    Aim and Method. To examine in obese people the potential effectiveness of a six-week, two times weekly aquajogging program on body composition, fitness, health-related quality of life, and exercise beliefs. Fifteen otherwise healthy obese persons participated in a pilot study. Results. Total fat

  3. Consumer Understanding of Nutrition Marketing Terms: A Pilot Study

    Science.gov (United States)

    Haroldson, Amber; Yen, Chih-Lun

    2016-01-01

    The purpose of this pilot study was to examine the validity of a questionnaire developed to assess adult consumer understanding of nutrition marketing terms and the resulting impact on consumer behavior. Participants (n = 40) completed an electronic questionnaire. Efforts to establish validity and reliability suggest that the questionnaire is a…

  4. Causes of Mortality among American College Students: A Pilot Study

    Science.gov (United States)

    Turner, James C.; Leno, E. Victor; Keller, Adrienne

    2013-01-01

    This pilot study from self-selected institutions of higher education provides an estimate of the causes and rates of mortality among college students between the ages of 18 and 24 years old. One hundred fifty-seven 4-year colleges participated in an online survey of student deaths during one academic year. A total of 254 deaths were reported. The…

  5. Favourable effects of consuming a Palaeolithic-type diet on characteristics of the metabolic syndrome: a randomized controlled pilot-study

    OpenAIRE

    Boers, Inge; Muskiet, Frits A. J.; Berkelaar, Evert; Schut, Erik; Penders, Ria; Hoenderdos, Karine; Wichers, Harry J.; Jong, Miek C.

    2014-01-01

    Background The main goal of this randomized controlled single-blinded pilot study was to study whether, independent of weight loss, a Palaeolithic-type diet alters characteristics of the metabolic syndrome. Next we searched for outcome variables that might become favourably influenced by a Paleolithic-type diet and may provide new insights in the pathophysiological mechanisms underlying the metabolic syndrome. In addition, more information on feasibility and designing an innovative dietary re...

  6. The prevalence and causes of bilateral and unilateral blindness in an elderly urban Danish population. The Copenhagen City Eye Study

    DEFF Research Database (Denmark)

    Buch, Helena; Vinding, T; La Cour, M

    2001-01-01

    PURPOSE: To study the prevalence and causes of bilateral and unilateral blindness in an elderly urban Danish population. METHODS: Data originated from a Danish epidemiologic cross-sectional random sample population eye survey conducted during the years 1986-1988. The population consisted of 1......) of blindness). RESULTS: The prevalence rates of bilateral and unilateral blindness were, respectively, 0.53% and 3.38% according to WHO, but 1.06% and 4.44% using NC. Bilateral blindness rose significantly with age (p=0.02). According to NC, age-related macular degeneration (AMD) was the leading cause...... of bilateral blindness, accounting for 60% of all blind persons. Glaucoma, myopic macular degeneration, cataract and retinitis pigmentosa were jointly the second most common cause, each accounting for 10% of all bilaterally blind persons. Diabetic retinopathy was not a cause of bilateral blindness. Amblyopia...

  7. Are headache and temporomandibular disorders related? A blinded study

    DEFF Research Database (Denmark)

    Ballegaard, V.; Thede-Schmidt-Hansen, P.; Svensson, P.

    2008-01-01

    /TMD) and classified in headache groups according to the International Classification of Headache Disorders, second edition for headache diagnoses in a blinded design. The prevalence of TMD in the headache population was 56.1%. Psychosocial dysfunction caused by TMD pain was observed in 40.4%. No significant......To investigate overlaps between headache and temporomandibular disorders (TMD) in a clinical headache population and to describe the prevalence of TMD in headache patients, 99 patients referred to a specialized headache centre were diagnosed according to Research Diagnostic Criteria for TMD (RDC...... differences in TMD prevalence were revealed between headache groups, although TMD prevalence tended to be higher in patients with combined migraine and tension-type headache. Moderate to severe depression was experienced by 54.5% of patients. Patients with coexistent TMD had a significantly higher prevalence...

  8. Dissolution studies with pilot plant and actual INTEC calcines

    International Nuclear Information System (INIS)

    Herbst, R.S.; Garn, T.G.

    1999-01-01

    The dissolution of Idaho Nuclear Technology and Engineering Center (INTEC) pilot plant calcines was examined to determine solubility of calcine matrix components in acidic media. Two representatives pilot plant calcine types were studied: Zirconia calcine and Zirconia/Sodium calcine. Dissolution of these calcines was evaluated using lower initial concentrations of nitric acid than used in previous tests to decrease the [H+] concentration in the final solutions. Lower [H+] concentrations contribute to more favorable TRUEX/SREX solvent extraction flowsheet performance. Dissolution and analytical results were also obtained for radioactive calcines produced using high sodium feeds blended with non-radioactive Al(NO 3 ) 3 solutions to dilute the sodium concentration and prevent bed agglomeration during the calcination process. Dissolution tests indicated >95 wt.% of the initial calcine mass can be dissolved using the baseline dissolution procedure, with the exception that higher initial nitric acid concentrations are required. The higher initial acid concentration is required for stoichiometric dissolution of the oxides, primarily aluminum oxide. Statistically designed experiments using pilot plant calcine were performed to determine the effect of mixing rate on dissolution efficiency. Mixing rate was determined to provide minimal effects on wt.% dissolution. The acid/calcine ratio and temperature were the predominate variables affecting the wt.% dissolution, a result consistent with previous studies using other similar types of pilot plant calcines

  9. Prevalence and causes of low vision and blindness in an urban population: The Chennai Glaucoma Study

    Directory of Open Access Journals (Sweden)

    Lingam Vijaya

    2014-01-01

    Full Text Available Aim: To evaluate the prevalence and causes of low vision and blindness in an urban south Indian population. Settings and Design: Population-based cross-sectional study. Exactly 3850 subjects aged 40 years and above from Chennai city were examined at a dedicated facility in the base hospital. Materials and Methods: All subjects had a complete ophthalmic examination that included best-corrected visual acuity. Low vision and blindness were defined using World Health Organization (WHO criteria. The influence of age, gender, literacy, and occupation was assessed using multiple logistic regression. Statistical Analysis: Chi-square test, t-test, and multivariate analysis were used. Results: Of the 4800 enumerated subjects, 3850 subjects (1710 males, 2140 females were examined (response rate, 80.2%. The prevalence of blindness was 0.85% (95% CI 0.6-1.1% and was positively associated with age and illiteracy. Cataract was the leading cause (57.6% and glaucoma was the second cause (16.7% for blindness. The prevalence of low vision was 2.9% (95% CI 2.4-3.4% and visual impairment (blindness + low vision was 3.8% (95% CI 3.2-4.4%. The primary causes for low vision were refractive errors (68% and cataract (22%. Conclusions: In this urban population based study, cataract was the leading cause for blindness and refractive error was the main reason for low vision.

  10. Design and pilot results of a single blind randomized controlled trial of systematic demand-led home visits by nurses to frail elderly persons in primary care [ISRCTN05358495

    Directory of Open Access Journals (Sweden)

    Tybout Willemijn

    2005-09-01

    Full Text Available Abstract Background The objective of this article is to describe the design of an evaluation of the cost-effectiveness of systematic home visits by nurses to frail elderly primary care patients. Pilot objectives were: 1. To determine the feasibility of postal multidimensional frailty screening instruments; 2. to identify the need for home visits to elderly. Methods Main study: The main study concerns a randomized controlled in primary care practices (PCP with 18 months follow-up and blinded PCPs. Frail persons aged 75 years or older and living at home but neither terminally ill nor demented from 33 PCPs were eligible. Trained community nurses (1 visit patients at home and assess the care needs with the Resident Assessment Instrument-Home Care, a multidimensional computerized geriatric assessment instrument, enabling direct identification of problem areas; (2 determine the care priorities together with the patient; (3 design and execute interventions according to protocols; (4 and visit patients at least five times during a year in order to execute and monitor the care-plan. Controls receive usual care. Outcome measures are Quality of life, and Quality Adjusted Life Years; time to nursing home admission; mortality; hospital admissions; health care utilization. Pilot 1: Three brief postal multidimensional screening measures to identify frail health among elderly persons were tested on percentage complete item response (selected after a literature search: 1 Vulnerable Elders Screen, 2 Strawbridge's frailty screen, and 3 COOP-WONCA charts. Pilot 2: Three nurses visited elderly frail patients as identified by PCPs in a health center of 5400 patients and used an assessment protocol to identify psychosocial and medical problems. The needs and experiences of all participants were gathered by semi-structured interviews. Discussion The design holds several unique elements such as early identification of frail persons combined with case-management by

  11. A yeast fermentate improves gastrointestinal discomfort and constipation by modulation of the gut microbiome: results from a randomized double-blind placebo-controlled pilot trial.

    Science.gov (United States)

    Pinheiro, Iris; Robinson, Larry; Verhelst, An; Marzorati, Massimo; Winkens, Björn; den Abbeele, Pieter Van; Possemiers, Sam

    2017-09-04

    Constipation and symptoms of gastrointestinal discomfort such as bloating are common among otherwise healthy individuals, but with significant impact on quality of life. Despite the recognized contribution of the gut microbiome to this pathology, little is known about which group(s) of microorganism(s) are playing a role. A previous study performed in vitro suggests that EpiCor® fermentate has prebiotic-like properties, being able to favorably modulate the composition of the gut microbiome. Therefore, the aim of this study was to investigate the effects of EpiCor fermentate in a population with symptoms of gastrointestinal discomfort and reduced bowel movements and to evaluate its effect at the level of the gut microbiome. This pilot study was performed according to a randomized, double-blind, placebo-controlled parallel design. Eighty subjects with symptoms of gastrointestinal discomfort and constipation were allocated to one of two trial arms (placebo or EpiCor fermentate). Randomization was done in a stratified manner according to symptom severity, resulting in two subgroups of patients: severe and moderate. Daily records of gastrointestinal symptoms were assessed on a 5-point scale, and also stool frequency and consistency were documented during a 2-week run-in and a 6-week intervention phases. Averages over two-week intervals were calculated. Constipation-associated quality of life and general perceived stress were assessed at baseline and after 3 and 6 weeks of intervention. Fecal samples were also collected at these same time points. EpiCor fermentate led to a significant improvement of symptoms such as bloating/distension (p = 0.033 and p = 0.024 after 2 and 4 weeks of intervention, respectively), feeling of fullness (p = 0.004 and p = 0.023 after 2 and 4 weeks of intervention, respectively) and general daily scores (p = 0.046 after 2 weeks of intervention) in the moderate subgroup. A significant improvement in stool consistency was observed

  12. High doses of biotin in chronic progressive multiple sclerosis: a pilot study.

    Science.gov (United States)

    Sedel, Frédéric; Papeix, Caroline; Bellanger, Agnès; Touitou, Valérie; Lebrun-Frenay, Christine; Galanaud, Damien; Gout, Olivier; Lyon-Caen, Olivier; Tourbah, Ayman

    2015-03-01

    No drug has been found to have any impact on progressive multiple sclerosis (MS). Biotin is a vitamin acting as a coenzyme for carboxylases involved in key steps of energy metabolism and fatty acids synthesis. Among others, biotin activates acetylCoA carboxylase, a potentially rate-limiting enzyme in myelin synthesis. The aim of this pilot study is to assess the clinical efficacy and safety of high doses of biotin in patients suffering from progressive MS. Uncontrolled, non-blinded proof of concept study 23 consecutive patients with primary and secondary progressive MS originated from three different French MS reference centers were treated with high doses of biotin (100-300mg/day) from 2 to 36 months (mean=9.2 months). Judgement criteria varied according to clinical presentations and included quantitative and qualitative measures. In four patients with prominent visual impairment related to optic nerve injury, visual acuity improved significantly. Visual evoked potentials in two patients exhibited progressive reappearance of P100 waves, with normalization of latencies in one case. Proton magnetic resonance spectroscopy (H-MRS) in one case showed a progressive normalization of the Choline/Creatine ratio. One patient with left homonymous hemianopia kept on improving from 2 to 16 months following treatment׳s onset. Sixteen patients out of 18 (89%) with prominent spinal cord involvement were considered as improved as confirmed by blinded review of videotaped clinical examination in 9 cases. In all cases improvement was delayed from 2 to 8 months following treatment׳s onset. These preliminary data suggest that high doses of biotin might have an impact on disability and progression in progressive MS. Two double-blind placebo-controlled trials are on going. Copyright © 2015 The Authors. Published by Elsevier B.V. All rights reserved.

  13. A pilot study into a possible relationship between diet and stuttering.

    Science.gov (United States)

    Hum, Jean; Rietveld, Toni; Wiedijk, Piet; van Lieshout, Pascal

    2017-06-01

    There are theoretical and empirical reasons to consider a potential role for copper metabolism in the brain in how it could influence stuttering. However, a link between stuttering and dietary intake has never been researched in a systematic way. This pilot study therefore aimed to explore a possible association between ingested amounts of copper and thiamine (vitamin B1) with stuttering frequency using a double blind cross-over longitudinal paradigm. 19 adults who stutter between 20 and 51 years old filled out an online survey for 9 consecutive weeks. The survey consisted of self-assessed fluency and mood state scales, as well as food journals. After 4 weeks, the participants consumed either copper or thiamine supplements for 2 weeks, followed by a 1-week washout period, and another period of two weeks taking the other supplement. Formal speech assessments were done pre/post baseline and at the end of each supplement intake. Participants were not informed about the nature of the supplements during the experiment and the investigators were blinded to the order of the supplements. The results demonstrated that copper and thiamine had no measurable effect on the amount of stuttering (self and formal assessments) but there was a moderate, significant correlation between mood state and fluency. The findings do not support notions of dietary influences of ingested copper or thiamine on stuttering but do provide modest support for a relationship between variations in stuttering and self-perceived anxiety. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. A Multicenter, Prospective, Randomized, Pilot Study of Outcomes for Digital Nerve Repair in the Hand Using Hollow Conduit Compared With Processed Allograft Nerve

    OpenAIRE

    Means, Kenneth R.; Rinker, Brian D.; Higgins, James P.; Payne, S. Houston; Merrell, Gregory A.; Wilgis, E. F. Shaw

    2016-01-01

    Background: Current repair options for peripheral nerve injuries where tension-free gap closure is not possible include allograft, processed nerve allograft, and hollow tube conduit. Here we report on the outcomes from a multicenter prospective, randomized, patient- and evaluator-blinded, pilot study comparing processed nerve allograft and hollow conduit for digital nerve reconstructions in the hand. Methods: Across 4 centers, consented participants meeting inclusion criteria while not meetin...

  15. Pilot Variability Study for Federal Aviation Administration Health and Usage Monitoring Mock Certification

    Science.gov (United States)

    2015-09-01

    ARL-TR-6922 ● SEP 2015 US Army Research Laboratory Pilot Variability Study for Federal Aviation Administration Health and Usage ...Laboratory Pilot Variability Study for Federal Aviation Administration Health and Usage Monitoring Mock Certification by Natasha C Bradley...October 2009–April 2014 4. TITLE AND SUBTITLE Pilot Variability Study for Federal Aviation Administration Health and Usage Monitoring Mock Certification

  16. A pilot randomized double-blind placebo-controlled trial on topical chamomile (Matricaria chamomilla L.) oil for severe carpal tunnel syndrome.

    Science.gov (United States)

    Hashempur, Mohammad Hashem; Lari, Zeinab Nasiri; Ghoreishi, Parissa Sadat; Daneshfard, Babak; Ghasemi, Mohammad Sadegh; Homayouni, Kaynoosh; Zargaran, Arman

    2015-11-01

    To assess the effectiveness of standardized topical Chamomile (Matricaria chamomilla L.) oil in patients with severe carpal tunnel syndrome, as a complementary treatment. A pilot randomized double-blind placebo-controlled trial was conducted. Twenty six patients with documented severe carpal tunnel syndrome were treated in two parallel groups with a night splint plus topical chamomile oil or placebo. They were instructed to use their prescribed oil for 4 weeks, twice daily. Symptomatic and functional status of the patients and their electrodiagnostic parameters were evaluated when enrolled and after the trial period, as our outcome measures. A significant improvement of symptomatic and functional status of patients in the chamomile oil group was observed (p = 0.019 and 0.016, respectively) compared with those in the placebo group. However, electrodiagnostic parameters showed no significant changes between the two groups. Chamomile oil improved symptomatic and functional status of patients with severe carpal tunnel syndrome. Copyright © 2015 Elsevier Ltd. All rights reserved.

  17. Structural differences in gray matter between glider pilots and non-pilots. A voxel based morphometry study.

    Directory of Open Access Journals (Sweden)

    Tosif eAhamed

    2014-11-01

    Full Text Available Glider flying is a unique skill that requires pilots to control an aircraft at high speeds in three dimensions and amidst frequent full body rotations. In the present study we investigated the neural correlates of flying a glider using voxel-based morphometry (VBM. The comparison between gray matter densities of 15 glider pilots and a control group of 15 non-pilots exhibited significant gray matter density increases in left ventral premotor cortex, anterior cingulate cortex and the supplementary eye field. We posit that the identified regions might be associated with cognitive and motor processes related to flying such as joystick control, visuo-vestibular interaction and oculomotor control.

  18. A remotely piloted aircraft system in major incident management: concept and pilot, feasibility study.

    Science.gov (United States)

    Abrahamsen, Håkon B

    2015-06-10

    Major incidents are complex, dynamic and bewildering task environments characterised by simultaneous, rapidly changing events, uncertainty and ill-structured problems. Efficient management, communication, decision-making and allocation of scarce medical resources at the chaotic scene of a major incident is challenging and often relies on sparse information and data. Communication and information sharing is primarily voice-to-voice through phone or radio on specified radio frequencies. Visual cues are abundant and difficult to communicate between teams and team members that are not co-located. The aim was to assess the concept and feasibility of using a remotely piloted aircraft (RPA) system to support remote sensing in simulated major incident exercises. We carried out an experimental, pilot feasibility study. A custom-made, remotely controlled, multirotor unmanned aerial vehicle with vertical take-off and landing was equipped with digital colour- and thermal imaging cameras, a laser beam, a mechanical gripper arm and an avalanche transceiver. We collected data in five simulated exercises: 1) mass casualty traffic accident, 2) mountain rescue, 3) avalanche with buried victims, 4) fisherman through thin ice and 5) search for casualties in the dark. The unmanned aerial vehicle was remotely controlled, with high precision, in close proximity to air space obstacles at very low levels without compromising work on the ground. Payload capacity and tolerance to wind and turbulence were limited. Aerial video, shot from different altitudes, and remote aerial avalanche beacon search were streamed wirelessly in real time to a monitor at a ground base. Electromagnetic interference disturbed signal reception in the ground monitor. A small remotely piloted aircraft can be used as an effective tool carrier, although limited by its payload capacity, wind speed and flight endurance. Remote sensing using already existing remotely piloted aircraft technology in pre

  19. Change-readiness of the blind: a hospital based study in a coastal town of South India.

    Science.gov (United States)

    Shetty, Ramya; Kulkarni, Uma D

    2014-01-01

    Blindness is a devastating condition with psychosocial and economic effects. The shortcomings result in a burden to the blind person, the family and society. Rehabilitation of the blind can transform their lives. The aim of this study was to assess the "change-readiness" of the blind to undergo a "change-management". The study was a semi-structured pre-tested questionnaire-based study of 50 blind subjects in a medical college hospital. The blind participants were assessed for depression using the Beck Depression Inventory II, for the perceived effect of blindness on family, social life and occupation. The participants were counseled to undergo psychiatric management, vocational training, use blind aids and learn Braille. The willingness of the participants with reasons was assessed using a verbal analogue scale. Pearson Chi-square test, ANOVA and the t-test were used for statistical analysis. Over two-thirds of the subjects were depressed. Family life, social life and occupation were perceived to be affected by 44%, 66% and 74%, respectively. Change-readiness scores were low for low vision and blind aids, vocational training, psychiatric management, change of job and learning Braille. The low score was due to the associated taboo, dependence, lack of skills, embarrassment, etc., The most valuable feature was the family cohesiveness. The results suggest that there is a need to modify health policy to include blind rehabilitation, to improve visibility of blind rehabilitation centers, to include family members and co-professionals while managing the blind so that we treat the "blind person" and not a "pair of blind eyes".

  20. Reparative therapy for acute ischemic stroke with allogeneic mesenchymal stem cells from adipose tissue: a safety assessment: a phase II randomized, double-blind, placebo-controlled, single-center, pilot clinical trial.

    Science.gov (United States)

    Díez-Tejedor, Exuperio; Gutiérrez-Fernández, María; Martínez-Sánchez, Patricia; Rodríguez-Frutos, Berta; Ruiz-Ares, Gerardo; Lara, Manuel Lara; Gimeno, Blanca Fuentes

    2014-01-01

    Few studies have evaluated the possible beneficial effect of the administration of stem cells in the early stages of stroke. Intravenous administration of allogeneic mesenchymal stem cells (MSCs) from adipose tissue in patients with acute stroke could be a safe therapy for promoting neurovascular unit repair, consequently supporting better functional recovery. We aim to assess the safety and efficacy of MSC administration and evaluate its potential as a treatment for cerebral protection and repair. A Phase IIa, prospective, randomized, double-blind, placebo-controlled, single-center, pilot clinical trial. Twenty patients presenting acute ischemic stroke will be randomized in a 1:1 proportion to treatment with allogeneic MSCs from adipose tissue or to placebo (or vehicle) administered as a single intravenous dose within the first 2 weeks after the onset of stroke symptoms. The patients will be followed up for 2 years. Primary outcomes for safety analysis: adverse events (AEs) and serious AEs; neurologic and systemic complications, and tumor development. Secondary outcomes for efficacy analysis: modified Rankin Scale; NIHSS; infarct size; and biochemical markers of brain repair (vascular endothelial growth factor, brain-derived neurotrophic factor, and matrix metalloproteinases 9). To our knowledge, this is the first, phase II, pilot clinical trial to investigate the safety and efficacy of intravenous administration of allogeneic MSCs from adipose tissue within the first 2 weeks of stroke. In addition, its results will help us define the best criteria for a future phase III study. Copyright © 2014 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  1. The Flower Workshop in psychosocial rehabilitation: a pilot study.

    Science.gov (United States)

    Pereira, Alfredo; Pereira, Maria Alice Ornellas

    2009-01-01

    We report a pilot study with the Flower Workshop, a new modality of psychosocial rehabilitation group activity. Cognitive performance in schizophrenia and other mental conditions can be impaired depending on the tasks to be executed and their respective social context. The vulnerability of these individuals can be reduced by means of cognitive and socio-affective facilitation. We conducted a pilot study to introduce the Flower Workshop in a public Mental Health Service in the city of Ribeirão Preto (São Paulo-Brasil) with 12 participants during 18 months (2002-2003). With cognitive and socio-affective facilitation, participants were able to construct vases and make flower arrangements successfully.

  2. Making the certainty based marking pilot study a reality

    Directory of Open Access Journals (Sweden)

    Stone BA

    2013-05-01

    Full Text Available Benjamin AT Stone, Thomas I LemonSchool of Medicine, Institute of Medical Education, Cardiff University, Cardiff, WalesWe thank the authors of "Use of certainty-based marking in a second-year medical student cohort: a pilot study"1 for their pilot study, we agree this is an interesting area that warrants further investigation. Schoendorfer and Emmett1 aimed to assess student opinion of certainty-based marking (CBM as a method of improving current curricula and explore the effectiveness of its implementation. If effective, the researchers believe CBM may increase the amount of certainty by those in professional health care roles.View original paper by Schoendorfer and Emmett.

  3. A pilot study of energy efficient air cleaning for ozone

    Energy Technology Data Exchange (ETDEWEB)

    Gundel, Lara A.; Sullivan, Douglas P.; Katsapov, Gregory Y.; Fisk, William J.

    2002-11-01

    A laboratory pilot study has been undertaken with the material that showed the most promise (high capacity and low pressure drop) based on the literature review and associated calculations. The best-performing air cleaner was a commercially available pleated filter that contained a thin layer of small activated carbon particles between two sheets of non-woven fibrous webbing. We will refer to this unit as the ''ozone filter'' although it is marketed for removal of volatile organic compounds (VOCs) from automobile passenger compartments. This pilot study strongly suggests that ozone air cleaning can be practical in commercial air handling systems; however, further tests are needed to assess air cleaner performance under a wider range of conditions.

  4. Perturbation During Treadmill Training Improves Dynamic Balance and Gait in Parkinson's Disease: A Single-Blind Randomized Controlled Pilot Trial.

    Science.gov (United States)

    Steib, Simon; Klamroth, Sarah; Gaßner, Heiko; Pasluosta, Cristian; Eskofier, Björn; Winkler, Jürgen; Klucken, Jochen; Pfeifer, Klaus

    2017-08-01

    Gait and balance dysfunction are major symptoms in Parkinson's disease (PD). Treadmill training improves gait characteristics in this population but does not reflect the dynamic nature of controlling balance during ambulation in everyday life contexts. To evaluate whether postural perturbations during treadmill walking lead to superior effects on gait and balance performance compared with standard treadmill training. In this single-blind randomized controlled trial, 43 PD patients (Hoehn & Yahr stage 1-3.5) were assigned to either an 8-week perturbed treadmill intervention (n = 21) or a control group (n = 22) training on the identical treadmill without perturbations. Patients were assessed at baseline, postintervention, and at 3 months' follow-up. Primary endpoints were overground gait speed and balance (Mini-BESTest). Secondary outcomes included fast gait speed, walking capacity (2-Minute Walk Test), dynamic balance (Timed Up-and-Go), static balance (postural sway), and balance confidence (Activities-Specific Balance Confidence [ABC] scale). There were no significant between-group differences in change over time for the primary outcomes. At postintervention, both groups demonstrated similar improvements in overground gait speed ( P = .009), and no changes in the Mini-BESTest ( P = .641). A significant group-by-time interaction ( P = .048) existed for the Timed Up-and-Go, with improved performance only in the perturbation group. In addition, the perturbation but not the control group significantly increased walking capacity ( P = .038). Intervention effects were not sustained at follow-up. Our primary findings suggest no superior effect of perturbation training on gait and balance in PD patients. However, some favorable trends existed for secondary gait and dynamic balance parameters, which should be investigated in future trials.

  5. Targeting Memory Improvement in Assisted Living: A Pilot Study

    OpenAIRE

    Williams, Kristine N.

    2011-01-01

    This pilot study tested an intervention designed to improve memory for Assisted Living (AL) residents. Seven residents in one midwestern AL facility participated in a 6-session memory program based on qualitative research that identified typical memory challenges of residents (remembering names, schedules, and appointments). Scores on memory self-efficacy (the Memory Complaint in Age-Associated Impairment [MAC-Q]) and performance (Rivermead Behavioral Memory Test) measures were compared befor...

  6. Generation Y students’ attitudes towards facebook advertising: pilot study results

    OpenAIRE

    Hilda Bongazana Mahlangu; Ayesha Lian Bevan-Dye

    2013-01-01

    The purpose of this paper is to report on the results of a pilot study conducted on the determinants and inhibitors of Generation Y students’ attitudes towards Facebook advertising. The findings suggest that Generation Y students have a positive attitude towards the information value, entertainment value, credibility, self-brand congruity of advertising on Facebook and attitude towards the social interaction value of Facebook. Their attitudes towards trust in the site and trust in the members...

  7. Familial Paraphilia: A Pilot Study with the Construction of Genograms

    OpenAIRE

    Labelle, Alain; Bourget, Dominique; Bradford, John M. W.; Alda, Martin; Tessier, Pierre

    2012-01-01

    Biological factors are likely predisposing and modulating elements in sexually deviant behavior. The observation that paraphilic behavior tends to cluster in some families is intriguing and potentially raises questions as to whether shared genetic factors may play a role in the transmission of paraphilia. This pilot study introduces five families in which we found presence of paraphilia over generations. We constructed genograms on the basis of a standardized family history. Results document ...

  8. Analysis of Fractured Teeth Utilizing Digital Microscopy: A Pilot Study

    Science.gov (United States)

    2016-06-01

    elicits pain in a fractured tooth is often obscure and difficult to reproduce in the dental chair . The type and consistency of pain may elicit a number of...ANALYSIS OF FRACTURED TEETH UTILIZING DIGITAL MICROSCOPY: A PILOT STUDY by Thomas Gene Cooper, D.M.D., M.P.H. Lieutenant Commander, Dental Corps...United States Navy A thesis submitted to the Faculty of the Endodontic Graduate Program Naval Postgraduate Dental School Uniformed Services

  9. Quality of life in the Iranian Blind War Survivors in 2007: a cross-sectional study

    Directory of Open Access Journals (Sweden)

    Amini Reza

    2010-08-01

    Full Text Available Abstract Background Quality of Life measurements are necessary tools for effectively evaluating health services. In the population of patients afflicted with war-related blindness in Iran, such measurements have yet to be documented and utilized. "The design and implementation of this study involved the determination of a baseline score for QOL in a population of Iranian blinded in the Iraq-Iran war in order to facilitate the design of interventions intended to improve the population's QOL." Methods This was a cross-sectional study of a representative population of 250 war victims blind in both eyes at a 14-day recreational conference. Results Participants had a mean age of 43.20(SD8.34 and their composition was 96.5% male and 3.5% female with a mean SF-36 QOL score of 59.20(SD22.80. An increasing level of education among the participants correlated with a higher QOL score (p = 0.006. The QOL also has a significant correlation to number of injuries (p Conclusions As blind war survivors' age, they will present with a greater set of burdens despite their relatively better QOL in the physical component scale when compared with lower limb amputees. Risk factors of cardiovascular attack such as high blood pressure and hypercholesterolemia were present and need future interventions. Key words Quality of life, blindness, SF36, health

  10. Low-Cost Radon Reduction Pilot Study

    Energy Technology Data Exchange (ETDEWEB)

    Rose, William B. [Partnership for Advanced Residential Retrofit, Champaign, IL (United States); Francisco, Paul W. [Partnership for Advanced Residential Retrofit, Champaign, IL (United States); Merrin, Zachary [Partnership for Advanced Residential Retrofit, Champaign, IL (United States)

    2015-09-01

    The aim of the research was to conduct a primary scoping study on the impact of air sealing between the foundation and the living space on radon transport reduction across the foundation-living space floor assembly. Fifteen homes in the Champaign, Illinois area participated in the study. These homes were instrumented for hourly continuous radon measurements and simultaneous temperature and humidity the foundation was improved. However, this improved isolation did not lead to significant reductions in radon concentration in the living space. Other factors such as outdoor temperature were shown to have an impact on radon concentration.

  11. Educational Optimism among Parents: A Pilot Study

    Science.gov (United States)

    Räty, Hannu; Kasanen, Kati

    2016-01-01

    This study explored parents' (N = 351) educational optimism in terms of their trust in the possibilities of school to develop children's intelligence. It was found that educational optimism could be depicted as a bipolar factor with optimism and pessimism on the opposing ends of the same dimension. Optimistic parents indicated more satisfaction…

  12. Motivation in the Classroom: A Pilot Study.

    Science.gov (United States)

    Schilling, Deanna E.

    Purposes of this study were to (1) investigate the validity of Maslow's Hierarchy of Needs as it applies to young children; (2) determine developmental shifts in expressed motivational needs; (3) gather information concerning the worries and fears of young children, particularly those of low socioeconomic status; and (4) gather data regarding…

  13. Analytic study of the Tadoma method: language abilities of three deaf-blind subjects.

    Science.gov (United States)

    Chomsky, C

    1986-09-01

    This study reports on the linguistic abilities of 3 adult deaf-blind subjects. The subjects perceive spoken language through touch, placing a hand on the face of the speaker and monitoring the speaker's articulatory motions, a method of speechreading known as Tadoma. Two of the subjects, deaf-blind since infancy, acquired language and learned to speak through this tactile system; the third subject has used Tadoma since becoming deaf-blind at age 7. Linguistic knowledge and productive language are analyzed, using standardized tests and several tests constructed for this study. The subjects' language abilities prove to be extensive, comparing favorably in many areas with hearing individuals. The results illustrate a relatively minor effect of limited language exposure on eventual language achievement. The results also demonstrate the adequacy of the tactile sense, in these highly trained Tadoma users, for transmitting information about spoken language sufficient to support the development of language and learning to produce speech.

  14. Heart valve viscoelastic properties - a pilot study

    Directory of Open Access Journals (Sweden)

    Kochová P.

    2007-10-01

    Full Text Available The effects of cryopreservation on the biological tissue mechanics are still largely unknown. Generalized Maxwell model was applied to characterize quantitatively the viscoelastic behavior of sheep mitral heart valve tissue. Three different groups of specimens are supposed to be tested: fresh tissue specimens (control group, cryopreserved allografts from tissue bank and allografts already used as tissue replacements taken from the animals approximately one year after the surgery. Specific aim of this study is to determine whether or not the treatment used for storage in tissue bank influences significantly the mechanical properties and behavior of the tissue. At the moment, only the first group of specimens was examined. The methodology presented in this paper proved suitable to complete the study.

  15. Causes and temporal trends of childhood blindness in Indonesia: study at schools for the blind in Java.

    Science.gov (United States)

    Sitorus, R S; Abidin, M Sulaiman; Prihartono, Joedo

    2007-09-01

    To ascertain the causes of blindness and severe visual impairment (BL/SVI) in schools for the blind in Java, to identify preventable and treatable causes and to evaluate temporal trends in the major causes. From a total of 504 students, 479 were examined. Data was collected using a modified World Heath Organization Prevention of Blindness (WHO/PBL) eye examination record for children. The majority of the students (95%) were blind and 4.6% were severely visually impaired. The major anatomical site of BL/SVI was whole globe in 35.9%, retina in 18.9%, lens in 16.4% and cornea in 16.1%. The major underlying aetiology of BL/SVI was undetermined/unknown in 32.7% (mainly microphthalmia, anterior segment dysgenesis and cataract), hereditary factors 31.9% (mainly retinal dystrophies), and childhood disorders 28.5%. Avoidable causes of BL/SVI accounted for 59.9% of the total students, whereas measles blindness was the underlying condition for 23.1% of the preventable causes; cataract and glaucoma accounted for 15.5% and 8.2% of the treatable causes, respectively. Exploration on trends of SVI/BL among two different age groups or = 16 years suggested that childhood disorders and corneal factors have declined, while hereditary disorders have increased. Optic nerve disorder, although not counted as a major cause of blindness, seems to be on the increase. More than half of the BL/SVI causes are potentially avoidable. Cataract and corneal disorders related to measles or vitamin A deficiency were the major treatable and preventable causes. Declining proportions of childhood factors and corneal disorders over a period of 10-20 years could reflect improved vitamin A supplementation and measles vaccination coverage in Indonesia. This finding, and the increased proportion of hereditary disease causes, could suggest improving levels of socioeconomic development and health care services.

  16. Pilot study of a multimodal intervention

    DEFF Research Database (Denmark)

    Jarden, Mary Ellen; Hovgaard, Doris; Boesen, Ellen

    2007-01-01

    Substantial physical and functional deconditioning and diminished psychological wellbeing are all potential adverse effects of allogeneic stem cell transplantation (allo-HSCT). The aim of this study was to evaluate the feasibility, safety and benefits (physical and functional capacity) of a 4......-6 week supervised and structured mixed-type exercise, progressive relaxation and psychoeducation programme in patients undergoing allo-HSCT. Nineteen patients were randomized to an intervention or a conventional care group (CC) and were tested for physical and functional capacity before admission...... muscle strength, and minimizing loss of physical and functional capacity in patients undergoing allo-HSCT....

  17. High-Resolution Scintimammography: A Pilot Study

    Energy Technology Data Exchange (ETDEWEB)

    Rachel F. Brem; Joelle M. Schoonjans; Douglas A. Kieper; Stan Majewski; Steven Goodman; Cahid Civelek

    2002-07-01

    This study evaluated a novel high-resolution breast-specific gamma camera (HRBGC) for the detection of suggestive breast lesions. Methods: Fifty patients (with 58 breast lesions) for whom a scintimammogram was clinically indicated were prospectively evaluated with a general-purpose gamma camera and a novel HRBGC prototype. The results of conventional and high-resolution nuclear studies were prospectively classified as negative (normal or benign) or positive (suggestive or malignant) by 2 radiologists who were unaware of the mammographic and histologic results. All of the included lesions were confirmed by pathology. Results: There were 30 benign and 28 malignant lesions. The sensitivity for detection of breast cancer was 64.3% (18/28) with the conventional camera and 78.6% (22/28) with the HRBGC. The specificity with both systems was 93.3% (28/30). For the 18 nonpalpable lesions, sensitivity was 55.5% (10/18) and 72.2% (13/18) with the general-purpose camera and the HRBGC, respectively. For lesions 1 cm, 7 of 15 were detected with the general-purpose camera and 10 of 15 with the HRBGC. Four lesions (median size, 8.5 mm) were detected only with the HRBGC and were missed by the conventional camera. Conclusion: Evaluation of indeterminate breast lesions with an HRBGC results in improved sensitivity for the detection of cancer, with greater improvement shown for nonpalpable and 1-cm lesions.

  18. Low-cost Radon Reduction Pilot Study

    Energy Technology Data Exchange (ETDEWEB)

    Rose, William B. [Univ. of Illinois, Urbana-Champaign, IL (United States); Francisco, Paul W. [Univ. of Illinois, Urbana-Champaign, IL (United States); Merrin, Zachary [Univ. of Illinois, Urbana-Champaign, IL (United States)

    2015-09-01

    The U.S. Department of Energy's Building America research team Partnership for Advanced Residential Retrofits conducted a primary scoping study on the impact of air sealing between the foundation and the living space on radon transport reduction across the foundation and living space floor assembly. Fifteen homes in the Champaign, Illinois, area participated in the study. These homes were instrumented for hourly continuous radon measurements and simultaneous temperature and humidity measurements. Blower door and zone pressure diagnostics were conducted at each house. The treatments consisted of using air-sealing foams at the underside of the floor that separated the living space from the foundation and providing duct sealing on the ductwork that is situated in the foundation area. The hypothesis was that air sealing the floor system that separated the foundation from the living space should better isolate the living space from the foundation; this isolation should lead to less radon entering the living space from the foundation. If the hypothesis had been proven, retrofit energy-efficiency programs may have chosen to adopt these isolation methods for enhanced radon protection to the living space.

  19. Treadmill Desks at LANL - Pilot Study

    Energy Technology Data Exchange (ETDEWEB)

    Fellows, Samara Kia [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2016-07-28

    It is well established that sedentariness is the largest, preventable contributor to premature death, eclipsing smoking in recent years. One approach to reduce sedentariness is by using a treadmill desk to perform office work while walking at a low speed.We found an increased interest level when the treadmill desks were first introduced to LANL, but after a few months interest appeared to drop. It is possible that treadmill desk use was occurring, but subjects did not record their use. The treadmill desks will not be readily available for purchase by employees due to the study outcome. Additionally, conclusive changes in body measurements could not be performed due to lack of follow up by 58% of the participants.

  20. Human biomonitoring pilot study DEMOCOPHES in Germany

    DEFF Research Database (Denmark)

    Schwedler, Gerda; Seiwert, Margarete; Fiddicke, Ulrike

    2017-01-01

    BP and higher concentrations of the phthalate metabolite MnBP. 2.5% of the German children had concentrations of the sum of 4 DEHP-metabolites and 4.2% had concentrations of MnBP that exceeded health based guidance values, indicating reasons for concern. Continuous HBM is necessary to track changes of pollutant...... and in the Higher Sauerland District, comprising 120 mother-child pairs. In the present paper features of the study implementation are presented. German exposure concentrations of the pollutants are reported and compared with European average concentrations from DEMOCOPHES and with those measured...... in the representative German Environmental Survey (GerES IV). German DEMOCOPHES concentrations for mercury and cotinine were lower than the European average. However, 47% of the children were still exposed to environmental tobacco smoke (ETS) outside their home, which gives further potential for enhancing protection...

  1. Ranitidine does not affect psoriasis: a multicenter, double-blind, placebo-controlled study

    NARCIS (Netherlands)

    Zonneveld, I. M.; Meinardi, M. M.; Karlsmark, T.; Johansen, U. B.; Kuiters, G. R.; Hamminga, L.; Staberg, B.; van't Veen, A. J.; Bossuyt, P. M.; van Niel, J. C.; Bos, J. D.

    1997-01-01

    BACKGROUND: Data from open studies suggest that ranitidine has a beneficial effect on psoriasis and is well tolerated. OBJECTIVE: Our purpose was to determine the effectiveness of ranitidine in a 24-week, multicenter, double-blind, placebo-controlled, dose-comparing study of 201 patients with

  2. A double-blind, placebo-controlled, randomized study of infliximab in primary sclerosing cholangitis

    NARCIS (Netherlands)

    Hommes, Daan W.; Erkelens, Willemien; Ponsioen, Cyriel; Stokkers, Pieter; Rauws, Erik; van der Spek, Mirjam; ten Kate, Fiebo; van Deventer, Sander J.

    2008-01-01

    GOALS: To evaluate the safety and efficacy of infliximab in patients with primary sclerosing cholangitis. STUDY: In this double-blind, placebo-controlled study, 24 patients with primary sclerosing cholangitis were screened and randomly assigned in a 2:1 ratio to receive infliximab (5 mg/kg) or

  3. Telemedicine and Plastic Surgery: A Pilot Study

    Directory of Open Access Journals (Sweden)

    Denis Souto Valente

    2015-01-01

    Full Text Available Background. Telemedicine can be defined as the use of electronic media for transmission of information and medical data from one site to another. The objective of this study is to demonstrate an experience of telemedicine in plastic surgery. Methods. 32 plastic surgeons received a link with password for real-time streaming of a surgery. At the end of the procedure, the surgeons attending the procedure by the Internet answered five questions. The results were analyzed with descriptive statistics. Results. 27 plastic surgeons attended the online procedure in real-time. 96.3% considered the access to the website as good or excellent and 3.7% considered it bad. 14.8% reported that the transmission was bad and 85.2% considered the quality of transmission as good or excellent. 96.3% classified the live broadcasting as a good or excellent learning experience and 3.7% considered it a bad experience. 92.6% reported feeling able to perform this surgery after watching the demo and 7.4% did not feel able. 100% of participants said they would like to participate in other surgical demonstrations over the Internet. Conclusion. We conclude that the use of telemedicine can provide more access to education and medical research, for plastic surgeons looking for medical education from distant regions.

  4. Frailty Testing Pilot Study: Pros and Pitfalls.

    Science.gov (United States)

    Adlam, Taylor; Ulrich, Elizabeth; Kent, Missy; Malinzak, Lauren

    2018-02-01

    Frailty can be defined as an inflammatory state with a loss of physiologic reserve in multiple systems that manifests as a decreased ability to respond to stressors that ultimately leads to an increased risk of adverse outcomes. The aim of this study was to determine the ease of frailty testing in a pre-kidney transplant clinic and the resources required to do so. A secondary goal was to better understand the utility of frailty testing when evaluating potential kidney transplant recipients. Frailty testing was conducted at a pre-kidney transplant clinic in three phases using Fried's frailty phenotype (shrinking, exhaustion, low physical activity, slowness, and grip strength). A total of 132 frailty tests were completed on 128 patients. Frail patients had significantly higher rates of shrinking (26% vs. 8.5%, P testing was most complete when an examiner dedicated to frailty testing performed the testing. Frailty testing is feasible to complete in a pre-transplant clinic with an appropriate investment in personnel and resources.

  5. Eating disorders in Silesian schools - pilot study.

    Science.gov (United States)

    Szczegielniak, Anna; Pałka, Karol; Krysta, Krzysztof; Krupka-Matuszczyk, Irena

    2012-09-01

    Modern media have a huge impact on eating habits, which result in pathologies among young people, especially females. Fashion models have become a pattern for ordinary women, however the difference in a mean weight between these two groups is increasing. The aim of the study was to assess the correlation between school students' results in EAT-26 self-report questionnaire and their daily diet behavior and to analyze the occurrence of eating disorders among students in schools of the region of Silesia in Poland. Our survey was based on the EAT-26 (Eating Attitude Test) and Behavioral Four Questions Test. 150 questionnaires were given to students of Secondary Schools, 116 were filled out correctly. The interviewed group consisted of 85 girls and 31 boys. Average age was 17.24±1.18. All of the data were analyzed statistically. Average BMI was 21,06; half of the recruited subjects had correct BMI whereas over 40% of them presented underweight. Within 116 responses from the EAT-26 nearly 93% belonged to the group with a small risk of the development of future eating disorders. Nevertheless, over 6% of the survey participants were in the group at high risk. In the Behavioral Four Questions Test 10% participants turned out to be in the compulsive overeating group, other ones in the group of a probable development of anorexia (7%) or bulimia nervosa (3%). There is a strong correlation between particular daily activities and the score achieved in EAT-26, however there is no significant correlation between the calculated BMI and EAT-26 results. Specific socio-cultural factors are faced by public services. They refer both to health promotion programs and the organization of spare time spent by teenagers outside schools.

  6. Colour blindness-A rural prevalence survey

    Directory of Open Access Journals (Sweden)

    Natu Maya

    1987-01-01

    Full Text Available Colour vision is important for aeroplane pilots, motor drivers, seamen and signal men for their professional work Not much of attention has been paid to population studies of colour blindness as there is no interference with daily routine in majority of persons However there is a need to undertake community wide prevalence surveys which could be useful in study of other genetically transmitted diseases

  7. Preliminary Hydrogeologic Characterization Results from the Wallula Basalt Pilot Study

    Energy Technology Data Exchange (ETDEWEB)

    B.P. McGrail; E. C. Sullivan; F. A. Spane; D. H. Bacon; G. Hund; P. D. Thorne; C. J. Thompson; S. P. Reidel; F. S. Colwell

    2009-12-01

    The DOE's Big Sky Regional Carbon Sequestration Partnership has completed drilling the first continental flood basalt sequestration pilot borehole to a total depth (TD) of 4,110 feet on the Boise White Paper Mill property at Wallula, Washington. Site suitability was assessed prior to drilling by the 2007-2008 acquisition, processing and analysis of a four-mile, five-line three component seismic swath, which was processed as a single data-dense line. Analysis of the seismic survey data indicated a composite basalt formation thickness of {approx}8,000 feet and absence of major geologic structures (i.e., faults) along the line imaged by the seismic swath. Drilling of Wallula pilot borehole was initiated on January 13, 2009 and reached TD on April 6, 2009. Based on characterization results obtained during drilling, three basalt breccia zones were identified between the depth interval of 2,716 and 2,910 feet, as being suitable injection reservoir for a subsequent CO2 injection pilot study. The targeted injection reservoir lies stratigraphically below the massive Umtanum Member of the Grande Ronde Basalt, whose flow-interior section possesses regionally recognized low-permeability characteristics. The identified composite injection zone reservoir provides a unique and attractive opportunity to scientifically study the reservoir behavior of three inter-connected reservoir intervals below primary and secondary caprock confining zones. Drill cuttings, wireline geophysical logs, and 31one-inch diameter rotary sidewall cores provided geologic data for characterization of rock properties. XRF analyses of selected rock samples provided geochemical characterizations of the rocks and stratigraphic control for the basalt flows encountered by the Wallula pilot borehole. Based on the geochemical results, the pilot borehole was terminated in the Wapshilla Ridge 1 flow of the Grande Ronde Basalt Formation. Detailed hydrologic test characterizations of 12 basalt interflow

  8. Sertraline treatment of pathological gambling: a pilot study.

    Science.gov (United States)

    Saiz-Ruiz, Jerónimo; Blanco, Carlos; Ibáñez, Angela; Masramon, Xavier; Gómez, Margarita M; Madrigal, María; Díez, Teresa

    2005-01-01

    Several open-label and double-blind studies have suggested that selective serotonin reuptake inhibitors may be useful in the treatment of pathological gambling. The purpose of this study was to evaluate the efficacy of sertraline in the treatment of pathological gambling. Sixty patients meeting the DSM-IV criteria for pathological gambling were treated for 6 months in a double-blind, flexible-dose, placebo-controlled study of sertraline 50 to 150 mg/day. Data were collected from November 1998 to January 2001. The primary outcome measure assessing change in clinical status was the responder rate with respect to the Criteria for Control of Pathological Gambling Questionnaire (CCPGQ). Secondary measures included the Clinical Global Impressions scale (CGI) (Severity of Illness and Improvement subscales), and Visual Analogue Scales assessing gambling frequency, severity, amount, and improvement. Concomitant medication and psychotherapy were not allowed during the study. At the end of the study, 23 sertraline-treated subjects (74%) and 21 placebo-treated subjects (72%) were considered as responders on the CCPGQ (p = .9). Similar results were obtained when the CGI-Improvement scale limited to symptoms of pathological gambling was used as an outcome measure. Sertraline was well tolerated throughout the study. Sertraline was not statistically significantly superior to placebo in the overall sample. The power of the study was limited by the high placebo-response rate and the small sample size.

  9. Pharmacogenetics of Ketamine-Induced Emergence Phenomena: A Pilot Study.

    Science.gov (United States)

    Aroke, Edwin N; Crawford, Sybil L; Dungan, Jennifer R

    Up to 55% of patients who are administered ketamine experience an emergence phenomena (EP) that closely mimics schizophrenia and increases their risk of injury; however, to date, no studies have investigated genetic association of ketamine-induced EP in healthy patients. The aim of the study was to investigate the feasibility and sample sizes required to explore the relationship between CYP2B6*6 and GRIN2B single-nucleotide polymorphisms and ketamine-induced EP. This cross-sectional, pharmacogenetic candidate, gene pilot study recruited 75 patients having minor elective outpatient surgeries. EP was measured with the Clinician Administered Dissociative State Scale. Genetic association of CYP2B6*6 and GRIN2B (rs1019385 and rs1806191) single-nucleotide polymorphisms and ketamine-induced EP occurrence and severity were tested using logistic and linear regression. Forty-seven patients (63%) received ketamine and were genotyped, and 40% of them experienced EP. Occurrence and severity of EP were not associated with CYP2B6*6 or GRIN2B (p > .10). Exploratory analysis of nongenotype models containing age, ketamine dose, duration of anesthesia, and time from ketamine administration to assessment for EP significantly predicted EP occurrence (p = .001) and severity (p = .007). This pilot study demonstrates feasibility for implementing a pharmacogenetic study in a clinical setting, and we estimate that between 380 and 570 cases will be needed to adequately power future genetic association studies. Younger age, higher dose, and longer duration of anesthesia significantly predicted EP occurrence and severity among our pilot sample. Although the small sample size limited our ability to demonstrate significant genotype differences, we generated effect sizes, sample size estimates, and nongenetic covariates information in order to support future pharmacogenetic study design for evaluating this adverse event.

  10. Incidence of blindness in relation to diabetes. A population-based study.

    Science.gov (United States)

    Trautner, C; Icks, A; Haastert, B; Plum, F; Berger, M

    1997-07-01

    A reduction of diabetes-related blindness was declared a primary objective for Europe (St. Vincent Declaration). We collected data about incidence rates of blindness in the diabetic population compared with the nondiabetic population. Up to now, such data are scarce-even worldwide. A complete list of newly registered blindness allowance recipients was drawn up in the district of Württemberg-Hohenzollern, Germany, between 1990 and 1993. From these data, we estimated age-specific and standardized incidence rates of blindness in the entire, the diabetic, and the nondiabetic population, as well as relative and attributable risks due to diabetes. There were 2,714 people meeting the inclusion criteria; 1,823 (67.2%) were female and 781 (28.8%) had diabetes. In 318 subjects, diabetes was likely to be the only cause of blindness; in 192 subjects, it was one of several contributory causes. Age of women was 73.9 +/- 19.4 years (mean +/- SD) and of men 63.3 +/- 25.5 years. Results standardized to the (West) German population are as follows: incidence rates (per 100,000 person-years): total population: 13.5; diabetic population: 60.6; nondiabetic population: 11.6; relative risk: 5.2; attributable risk among exposed: 0.81; and population attributable risk: 0.14. The relative risks decreased considerably with increasing age. When the study is repeated to monitor the St. Vincent targets, a reduction in the incidence rate of blindness in the diabetic population by 17% will be detected with 95% power. Great relative and attributable risks, especially in younger age-groups, indicate the need for increased attention to preventive measures for microvascular complications.

  11. Increased neutrophil–lymphocyte ratio in delirium: a pilot study

    Directory of Open Access Journals (Sweden)

    Egberts A

    2017-07-01

    Full Text Available Angelique Egberts, Francesco US Mattace-Raso Section of Geriatric Medicine, Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands Aim: Delirium is a common and severe complication among older hospitalized patients. The pathophysiology is poorly understood, but it has been suggested that inflammation and oxidative stress may play a role. The aim of this pilot study was to investigate levels of the neutrophil–lymphocyte ratio (NLR – a marker of systemic inflammation and oxidative stress – in patients with and without delirium. Methods: This pilot study was performed within a retrospective chart review study that included acutely ill patients, 65 years and older, who were admitted to the ward of geriatrics of the Erasmus University Medical Center. All patients in whom the differential white blood cell (WBC counts as well as the C-reactive protein (CRP level were determined within 24 h after admission were included in the present study. Differences in NLR between patients with and without delirium were investigated using univariate analysis of variance, with adjustments for age, sex, comorbidities, CRP level, and total WBC count. Results: Eighty-six patients were included. Thirteen patients were diagnosed with delirium. In adjusted models, higher mean NLR values were found in patients with, than in those without, delirium (9.10 vs 5.18, P=0.003. Conclusion: In this pilot study, we found increased NLR levels in patients with delirium. This finding might suggest that an inadequate response of the immune system and oxidative stress may play a role in the pathogenesis of delirium. Further studies are needed to confirm the association between NLR and delirium. Keywords: delirium, pathology, biomarkers, leukocytes, immune system, brain 

  12. A Double Blind Study Comparing Virucare and Inter-feron as ...

    African Journals Online (AJOL)

    Objective: To present the results of a comparative double blind study between. Virucare and Interferon to evaluate their efficacy, safety and tolerability in treating Hepatitis C Virus and its complications. Keywords: Hepatitis C, polymerase chain reaction, interferon. Egypt. J. Hum. Genet Vol. 9 (1) 2008: pp. 71-84 ...

  13. Blindness and visual impairment in the Niger Delta: A study of ...

    African Journals Online (AJOL)

    %) and chorioretinitis (12.5%), while the common causes of visual impairment were cataract (33.8%), refractive error (26.8%) and glaucoma (26.8%). Conclusion: A relatively high rate of blindness was found in the study area, caused by ...

  14. A double-blind, placebo-controlled study of sertraline with naltrexone for alcohol dependence.

    LENUS (Irish Health Repository)

    Farren, Conor K

    2009-01-01

    Significant preclinical evidence exists for a synergistic interaction between the opioid and the serotonin systems in determining alcohol consumption. Naltrexone, an opiate receptor antagonist, is approved for the treatment of alcohol dependence. This double-blind placebo-controlled study examined whether the efficacy of naltrexone would be augmented by concurrent treatment with sertraline, a selective serotonin receptor uptake inhibitor (SSRI).

  15. Textual Input Enhancement for Vowel Blindness: A Study with Arabic ESL Learners

    Science.gov (United States)

    Alsadoon, Reem; Heift, Trude

    2015-01-01

    This study explores the impact of textual input enhancement on the noticing and intake of English vowels by Arabic L2 learners of English. Arabic L1 speakers are known to experience "vowel blindness," commonly defined as a difficulty in the textual decoding and encoding of English vowels due to an insufficient decoding of the word form.…

  16. Reversible Autism among Congenitally Blind Children? A Controlled Follow-Up Study

    Science.gov (United States)

    Hobson, R. Peter; Lee, Anthony

    2010-01-01

    Background: Atypical forms of autism may yield insights into the development and nature of the syndrome. Methods: We conducted a follow-up study of nine congenitally blind and seven sighted children who, eight years earlier, had satisfied formal diagnostic criteria for autism and had been included in groups matched for chronological age and verbal…

  17. Seeing Chemistry through the Eyes of the Blind: A Case Study Examining Multiple Gas Law Representations

    Science.gov (United States)

    Harshman, Jordan; Bretz, Stacey Lowery; Yezierski, Ellen

    2013-01-01

    Adequately accommodating students who are blind or low-vision (BLV) in the sciences has been a focus of recent inquiry, but much of the research to date has addressed broad accommodations rather than devising and testing specific teaching strategies that respond to the unique challenges of BLV students learning chemistry. This case study seeks to…

  18. Effect of Diet on Gulf War Illness: A Pilot Study

    Science.gov (United States)

    2017-10-01

    Award Number: W81XWH-15-1-0636 TITLE: Effect of Diet on Gulf War Illness: A Pilot Study PRINCIPAL INVESTIGATOR: Ashok Tuteja, M.D. M.P.H...CONTRACT NUMBER Effect of Diet on Gulf War Illness 5b. GRANT NUMBER W81XWH-15-1-0636 5c. PROGRAM ELEMENT NUMBER 6 . AUTHOR(S) 5d. PROJECT NUMBER...overall objective of the study is to determine the efficacy of a Low FODMAP (modified healthy) diet relative to a High FODMAP (typical healthy) diet in

  19. The effect of fluoride toothpaste on root dentine demineralization progression: a pilot study

    Directory of Open Access Journals (Sweden)

    Juliana Nunes Botelho

    2014-02-01

    Full Text Available The anticaries effect of fluoride (F toothpaste containing 1100 µg F/g in reducing enamel demineralization is well established, but its effect on dentine has not been extensively studied. Furthermore, it has been shown that toothpaste containing a high F concentration is necessary to remineralize root dentine lesions, suggesting that a 1100 µg F/g concentration might not be high enough to reduce root dentine demineralization, particularly when dentine is subjected to a high cariogenic challenge. Thus, the aim of this pilot study was to evaluate in situ the effect of F toothpaste, at a concentration of 1100 µg F/g, on dentine demineralization. In a crossover and double-blind study, conducted in two phases of 14 days, six volunteers wore a palatal appliance containing four slabs of bovine root dentine whose surface hardness (SH was previously determined and to which a 10% sucrose solution was applied extra-orally 8×/day. Volunteers used a non-F toothpaste (negative control or F toothpaste (1100 µg F/g, NaF/SiO2 three times a day. On the 10th and 14th days of each phase, two slabs were collected and SH was determined again. Dentine demineralization was assessed as percentage of SH loss (%SHL. The effect of toothpaste was significant, showing lower %SHL for the F toothpaste group (42.0 ± 9.7 compared to the non-F group (62.0 ± 6.4; p 0.05. This pilot study suggests that F toothpaste at 1100 µg F/g is able to decrease dentine caries even under a high cariogenic challenge of biofilm accumulation and sugar exposure.

  20. Therapeutic role of Vitamin B12 in patients of chronic tinnitus: A pilot study.

    Science.gov (United States)

    Singh, Charu; Kawatra, Rahul; Gupta, Jaya; Awasthi, Vishnu; Dungana, Homnath

    2016-01-01

    True tinnitus is a phantom auditory perception arising from a source or trigger in the cochlea, brainstem, or at higher centers and has no detectable acoustic generator. The most accepted is the famous neurophysiologic model of Jastreboff, which stresses that tinnitus, is a subcortical perception and results from the processing of weak neural activity in the periphery. The aim of this study is to determine the role of Vitamin B12 in treatment of chronic tinnitus. In this randomized, double-blind pilot study, total 40 patients were enrolled, of which 20 in Group A (cases) received intramuscular therapy of 1 ml Vitamin B12 (2500 mcg) weekly for a period of 6 weeks and Group B (20) patients received placebo isotonic saline 01 ml intramuscular. The patients were subjected to Vitamin B12 assay and audiometry pre- and post-therapy. Of the total patients of tinnitus, 17 were Vitamin B12 deficient that is 42.5% showed deficiency when the normal levels were considered to be 250 pg/ml. A paired t-test showed that in Group A, patients with Vitamin B12 deficiency showed significant improvement in mean tinnitus severity index score and visual analog scale (VAS) after Vitamin B12 therapy. This pilot study highlights the significant prevalence of Vitamin B12 deficiency in North Indian population and improvement in tinnitus severity scores and VAS in cobalamin-deficient patients receiving intramuscular Vitamin B12 weekly for 6 weeks further provides a link between cobalamin deficiency and tinnitus thereby suggestive of a therapeutic role of B12 in cobalamin-deficient patients of tinnitus.

  1. Therapeutic role of Vitamin B12 in patients of chronic tinnitus: A pilot study

    Directory of Open Access Journals (Sweden)

    Charu Singh

    2016-01-01

    Full Text Available True tinnitus is a phantom auditory perception arising from a source or trigger in the cochlea, brainstem, or at higher centers and has no detectable acoustic generator. The most accepted is the famous neurophysiologic model of Jastreboff, which stresses that tinnitus, is a subcortical perception and results from the processing of weak neural activity in the periphery. The aim of this study is to determine the role of Vitamin B12 in treatment of chronic tinnitus. In this randomized, double-blind pilot study, total 40 patients were enrolled, of which 20 in Group A (cases received intramuscular therapy of 1 ml Vitamin B12 (2500 mcg weekly for a period of 6 weeks and Group B (20 patients received placebo isotonic saline 01 ml intramuscular. The patients were subjected to Vitamin B12 assay and audiometry pre- and post-therapy. Of the total patients of tinnitus, 17 were Vitamin B12 deficient that is 42.5% showed deficiency when the normal levels were considered to be 250 pg/ml. A paired t-test showed that in Group A, patients with Vitamin B12 deficiency showed significant improvement in mean tinnitus severity index score and visual analog scale (VAS after Vitamin B12 therapy. This pilot study highlights the significant prevalence of Vitamin B12 deficiency in North Indian population and improvement in tinnitus severity scores and VAS in cobalamin-deficient patients receiving intramuscular Vitamin B12 weekly for 6 weeks further provides a link between cobalamin deficiency and tinnitus thereby suggestive of a therapeutic role of B12 in cobalamin-deficient patients of tinnitus.

  2. A prospective single-blind study of Gamma Knife thalamotomy for tremor.

    Science.gov (United States)

    Witjas, Tatiana; Carron, Romain; Krack, Paul; Eusebio, Alexandre; Vaugoyeau, Marianne; Hariz, Marwan; Azulay, Jean Philippe; Régis, Jean

    2015-11-03

    To evaluate the safety and efficacy of unilateral Gamma Knife thalamotomy (GKT) for treatment of severe tremor with a prospective blinded assessment. Fifty patients (mean age: 74.5 years; 32 men) with severe refractory tremor (36 essential, 14 parkinsonian) were treated with unilateral GKT. Targeting of the ventral intermediate nucleus (Vim) was achieved with Leksell Gamma Knife with a single shot through a 4-mm collimator helmet. The prescription dose was 130 Gy. Neurologic and neuropsychological assessments including a single-blinded video assessment of the tremor severity performed by a movement disorders neurologist from another center were performed before and 12 months after treatment. MRI follow-up occurred at 3, 6, and 12 months. The upper limb tremor score improved by 54.2% on the blinded assessment (p < 0.0001). All tremor components (rest, postural, and intention) were improved. Activities of daily living were improved by 72.2%. Cognitive functions remained unchanged. Following GKT, the median delay of improvement was 5.3 months (range 1-12 months). The only side effect was a transient hemiparesis associated with excessive edema around the thalamotomy in one patient. This blinded prospective assessment demonstrates that unilateral GKT is a safe and efficient procedure for severe medically refractory tremor. Side effects were rare and transient in this study. This study provides Class IV evidence that for patients with severe refractory tremor, GKT is well tolerated and effective in reducing tremor impairment. © 2015 American Academy of Neurology.

  3. Patterns of Sweet Taste Liking: A Pilot Study

    OpenAIRE

    Keiko Asao; Jason Miller; Leann Arcori; Julie C. Lumeng; Theresa Han-Markey; William H. Herman

    2015-01-01

    Two distinct patterns of sweet taste liking have been described: one showing a peak liking response in the mid-range of sucrose concentrations and the other showing a monotonic liking response at progressively higher sucrose concentrations. Classification of these patterns has been somewhat arbitrary. In this report, we analyzed patterns of sweet taste liking in a pilot study with 26 adults including 14 women and 12 men, 32.6 ± 14.5 years of age with body mass index 26.4 ± 5.1 kg/m2 (mean ± S...

  4. Effects of Aquajogging in Obese Adults: A Pilot Study

    OpenAIRE

    Wouters, Eveline J. M.; Van Nunen, Annemieke M. A.; Geenen, Rinie; Kolotkin, Ronette L.; Vingerhoets, Ad J. J. M.

    2009-01-01

    Aim and Method. To examine in obese people the potential effectiveness of a six-week, two times weekly aquajogging program on body composition, fitness, health-related quality of life, and exercise beliefs. Fifteen otherwise healthy obese persons participated in a pilot study. Results. Total fat mass and waist circumference decreased 1.4 kg (P = .03) and 3.1 cm (P = .005), respectively. The distance in the Six-Minute Walk Test increased 41 meters (P = .001). Three scales of the Impact of Weig...

  5. The Expanded Core Curriculum at the Indiana School for the Blind and Visually Impaired: A Case Study

    Science.gov (United States)

    Ringwalt, Gail Mulholland

    2013-01-01

    This case study investigated how the Expanded Core Curriculum (ECC) was taught to high school students who are blind or visually impaired at the Indiana School for the Blind and Visually Impaired (ISBVI). The study focused on three students pursing different academic tracks with varying degrees of vision. The students were observed throughout…

  6. Is dipyrone effective as a preemptive analgesic in third molar surgery? A pilot study.

    Science.gov (United States)

    Favarini, Vinícius Tatsumoto; Lima, Carlos Alysson Aragão; da Silva, Rogério Almeida; Sato, Fábio Ricardo Loureiro

    2018-03-01

    Studies on preemptive analgesia in maxillofacial surgery have shown several controversial clinical results, mainly due to the absence of a methodological standard, besides a wide variety of studied drugs. This study intended to answer the following hypothesis: Is the administration of dipyrone preemptively capable of decreasing trans- and postoperative pain in the third molar surgical extraction? A pilot prospective double-blind placebo-controlled study was carried out with 25 patients submitted to the third molar surgical extraction at two moments, one side in each intervention. Dipyrone (1 g) was preemptively administered (study group) for the extraction of two third molars on the same side and, in a second surgical procedure, dipyrone (1 g) was administered in the immediate postoperative period (control group). Evaluated variables were the amount of anesthetic, pain perceived through the visual analogue scale (VAS) in transoperative and immediate postoperative periods, and over 12-h investigation period, analgesic consumption, duration of surgery, and time to rescue analgesia. The results were submitted to Student's t test and statistical differences were observed in transoperative (p surgery only.

  7. Evaluation of an oral telomerase activator for early age-related macular degeneration - a pilot study.

    Science.gov (United States)

    Dow, Coad Thomas; Harley, Calvin B

    2016-01-01

    Telomere attrition and corresponding cellular senescence of the retinal pigment epithelium contribute to the changes of age-related macular degeneration. Activation of the enzyme telomerase can add telomeric DNA to retinal pigment epithelium chromosomal ends and has been proposed as a treatment for age-related macular degeneration. We report the use of a small molecule, oral telomerase activator (TA)-65 in early macular degeneration. This study, focusing on early macular degeneration, provides a model for the use of TAs in age-related disease. Thirty-eight (38) patients were randomly assigned to a 1-year, double-blinded, placebo-controlled interventional study with arms for oral TA-65 or placebo. Macular functions via micro-perimetry were the primary measured outcomes. The macular function in the arm receiving the TA-65 showed significant improvement relative to the placebo control. The improvement was manifest at 6 months and was maintained at 1 year: macular threshold sensitivity (measured as average dB [logarithmic decibel scale of light attenuation]) improved 0.97 dB compared to placebo (P-value 0.02) and percent reduced thresholds lessened 8.2% compared to the placebo arm (P-value 0.04). The oral TA significantly improved the macular function of treatment subjects compared to controls. Although this study was a pilot and a larger study is being planned, it is noteworthy in that it is, to our knowledge, the first randomized placebo-controlled study of a TA supplement.

  8. Improving collaborative care in managing eating disorders: a pilot study.

    Science.gov (United States)

    Heath, Olga; English, Denise; Simms, Joanne; Ward, Pamela; Hollett, Ann; Dominic, Anna

    2013-01-01

    The purpose of this pilot study was to evaluate the impact of a continuing interprofessional educational workshop focused on eating disorders in a rural area in Newfoundland and Labrador (NL), Canada. The pilot study helped determine if the eating disorder workshop was feasible for implementation to a broader audience. A conceptual model developed by our eating disorder team and described in the article guided this innovative program. The intensive 2-day workshop was piloted in one community with 41 health and education professionals in attendance. A key element was the focus on creating and sustaining collaborative care for eating disorders. Participants completed pre-post workshop measures of interprofessional attitudes and skills, self-reported knowledge, confidence, and intention to change practice (post questionnaire only). A 6-month follow-up survey measured self-reported practice change. There were significant positive changes in interprofessional attitudes and skills as well as knowledge and confidence in collaborative management of eating disorders. Post-workshop, 69% (n = 24/35) of participants indicated intention to change practice, and on follow-up, 7 of 10 respondents reported implementing changes in practice as a result of the workshop. Low response rate at follow-up was a limitation. Results support the impact of the workshop in improving knowledge, confidence, and attitudes toward collaboration and changing practice and the value of implementing the program province-wide. Copyright © 2013 The Alliance for Continuing Education in the Health Professions, the Society for Academic Continuing Medical Education, and the Council on CME, Association for Hospital Medical Education.

  9. Mindfulness-based stress reduction for Tourette Syndrome and Chronic Tic Disorder: a pilot study.

    Science.gov (United States)

    Reese, Hannah E; Vallejo, Zayda; Rasmussen, Jessica; Crowe, Katherine; Rosenfield, Elizabeth; Wilhelm, Sabine

    2015-03-01

    In this pilot study we sought to develop and test a modified form of mindfulness-based stress reduction (MBSR-tics) for the treatment of Tourette Syndrome (TS) and Chronic Tic Disorder (CTD). Our specific aims were: 1) To determine the feasibility and acceptability of an 8-week trial of MBSR-tics in individuals 16 and older with TS or CTD and 2) To determine the efficacy of an 8-week trial of MBSR-tics in individuals 16 and older with TS or CTD. Eighteen individuals age 16-67 completed an uncontrolled open trial of MBSR-tics. The intervention consisted of 8 weekly 2-hour classes and one 4hour retreat in the fifth or sixth week of the program. Symptomatic assessments were performed at baseline, post-treatment, and one-month follow-up. MBSR-tics proved to be a feasible and acceptable intervention. It resulted in significant improvement in tic severity and tic-related impairment. 58.8% of subjects were deemed treatment responders. Therapeutic gains were maintained at 1-month follow-up. Improvements in tic severity were correlated with increases in self-reported levels of mindfulness. This small open pilot study provides preliminary support for the feasibility, acceptability, and efficacy of MBSR-tics for individuals 16 or older with TS or CTD. A larger randomized controlled trial with blind assessment is necessary to confirm these initial, promising findings. Trial Registration Partners Clinical Trials Registry Number 2011P000606 (clinicaltrials.partners.org). Copyright © 2014 Elsevier Inc. All rights reserved.

  10. Indonesian EFL Students’ Perspective on Writing Process: A Pilot Study

    Directory of Open Access Journals (Sweden)

    Imelda Hermilinda Abas

    2016-06-01

    Full Text Available The study was aimed at understanding the EFL Indonesian students’ perspective on the writing process. The pilot study involved two male Indonesian postgraduate students in Universiti Utara Malaysia. The Indonesian students were selected based on the following criteria: (1 had enough knowledge in English writing, indicated by the completion of Academic Writing and Research Methodology courses taken in UUM; (2 had written an unpublished thesis during their undergraduate studies in Indonesia and they are writing their master or doctoral thesis in English; (3 used English extensively in writing their assignments, and in daily activities. Pseudonyms were used to refer to the participants as Sukarno and Suharto. The data were collected through in-depth interviews with the participants. The interview sessions took approximately 15-20 minutes for each participant and were videotaped and audiotaped. Semi-structured interview with 15 questions and probes were used. The results showed that the two participants had positive feelings and attitudes towards writing in English. Although they had a hard time in English writing during their undergraduate in Indonesia, they become fond of writing in English in their postgraduate time due to the exposure to English extensively. In composing, they used brainstorming, drafting, pausing, revising and editing in a recursive manner. Keywords: in-depth interview, pilot study, writing process, English as a Foreign Language (EFL

  11. Mantram Repetition With Homeless Women: A Pilot Study.

    Science.gov (United States)

    Weinrich, Sally P; Bormann, Jill E; Glaser, Dale; Hardin, Sally; Barger, Mary; Lizarraga, Cabiria; Del Rio, Juan; Allard, Carolyn B

    Women and families are the fastest growing segment of the homeless population. Negative attitudes of nurses toward homeless women are a major barrier to homeless women seeking health care. This cross-sectional, mixed-methods pilot study, conducted primarily by nurses, tested the Mantram Repetition Program for the first time with 29 homeless women. The Mantram Repetition Program is a spiritually based skills training that teaches mantram (sacred word) repetition as a cost-effective, personalized, portable, and focused strategy for reducing stress and improving well-being. For the cross-sectional, pretest-posttest design portion of the study, the hypothesis that at least half of the homeless women would repeat their mantram at least once a day was supported with 88% of the women repeating their mantram 1 week later. The qualitative portion of this study using phenomenology explored the women's thoughts on mantram week 2. Themes of mantram repetition, mantram benefits, and being cared for emerged. This groundbreaking, interventional, mixed-methods pilot study fills a gap in interventional homeless research.

  12. Visual impairment and blindness in rural central India: the Central India Eye and Medical Study.

    Science.gov (United States)

    Nangia, Vinay; Jonas, Jost B; Gupta, Rajesh; Khare, Anshu; Sinha, Ajit

    2013-08-01

    The aim of the study was to investigate prevalence of visual impairment in rural central India. The population-based Central India Eye and Medical Study included 4711 subjects with an age of 30+ years. Presenting visual acuity (PRVA) and best-corrected visual acuity (BCVA) were recorded. Visual impairment and blindness were defined using the World Health Organization (WHO) standard and United States (US) standard. On the basis of PRVA and using WHO and US standards, 1049 [22%; 95% confidence interval (CI): 21.1, 23.5] subjects and 1290 (27%; 95% CI: 26.1, 28.7) subjects, respectively, were visually impaired, and 35 (0.7%; 95% CI: 0.5, 1.0) subjects and 116 (2.5%; 95% CI: 2.0, 2.9) subjects, respectively, were blind. The corresponding age-standardized prevalence figures were 17%, 21%, 0.5% and 2%, respectively. Using best-correcting glasses could eliminate PRVA-visual impairment/blindness in 729 subjects (67% of all subjects with visual impairment/blindness). On the basis of BCVA and using WHO and US standards, 333 (7%; 95% CI: 6.3, 7.8) subjects and 473 (10%; 95% CI: 9.2, 10.9) subjects, respectively, had visual impairment, and 22 (0.5%; 95% CI: 0.3, 0.7) and 31 (0.7%; 95% CI: 0.4, 0.9) subjects, respectively, were blind. Corresponding age-standardized prevalence figures were 5%, 8%, 0.4% and 0.5%, respectively. Causes for BCVA-visual impairment/blindness were cataract (75%), postoperative posterior capsular opacification (4%), surgical complications (2%), corneal opacifications (2%), age-related macular degeneration (2%), other macular diseases (1%), and glaucoma (1%). Age-standardized prevalence of PRVA-visual impairment/blindness (WHO definition) in the adult population of rural central India was 17%. Most frequent cause was undercorrected refractive error. Supply of correct glasses is the most efficient way to improve vision in the rural central India. © 2012 The Authors. Acta Ophthalmologica © 2012 Acta Ophthalmologica Scandinavica Foundation.

  13. Pharmacovigilance in veterinary medicine in Chile: a pilot study.

    Science.gov (United States)

    Iragüen, D; Urcelay, S; San Martín, B

    2011-04-01

    Iragüen, D., Urcelay, S., San Martín, B. Pharmacovigilance in veterinary medicine in Chile: a pilot study. J. vet. Pharmacol. Therap.34, 108-115. In Chile, there is no present government policy to survey and analyse adverse drug reactions (ADRs) in the field of veterinary medicine. The intent of this study is to assess, for the first time, ADR frequency in treated animals. To this purpose, a 6-month period pilot study based on WHO recommendations was conducted to monitor ADRs in cats and dogs for frequently used drugs and common labelled signs. Of a total of 149 detected ADRs, 29 (6 in cats and 23 in dogs) were notified by means of ADR report forms, while the rest was identified after reviewing patient clinical records, thus evidencing strong under-reporting problems. More than 70% of ADRs were related to antimicrobials, vaccines and tranquilizers. In dogs, there was a significant effect on ADRs' presentation when acepromazine, amoxicillin, carprofen, ivermectin, sextuple vaccine (polyvalent vaccine that confers immunity against canine distemper virus, canine parvovirus, Leptospira canicola, L. icterohemmoragiae, canine adenovirus type 2 and canine parainfluenza virus) and phytomenadione (subcutaneous injection) were administered. In the case of cats, a significant influence on ADRs was detected when acepromazine, amoxicillin or vitamin K was administered. Present results suggest the need for a pharmacovigilance programme in veterinary medicine for timely ADR-presenting drug detection and drug safety improvement. © 2010 Blackwell Publishing Ltd.

  14. Pilot study dismantlement of 20 lead-lined shipping casks

    International Nuclear Information System (INIS)

    Thurmond, S.M.

    1995-08-01

    This report describes a pilot study conducted at the INEL to dismantle lead-lined casks and shielding devices, separate the radiologically contaminated and hazardous materials, and recycle resultant scrap lead. The facility areas where the work was performed, dismantlement methods, and process equipment are described. Issues and results associated with recycling the lead as a free-released scrap metal are presented and discussed. Data and results from the pilot study are summarized and presented. The study concluded that cask dismantlement at the INEL can be performed as a legitimate recycling activity for scrap lead. Ninety-one percent of the lead recovered passed free-release criteria. The value of the 50,375 lb of recovered lead is approximately $0.45/lb. Resultant waste streams can be satisfactorily treated and disposed. Only very low levels of bulk radiological contamination (47 picocuries/gram of 137 Cs and 3.2 picocuries/gram of 6O Co) were detected in the lead rejected for free release

  15. Pediatric Trauma Boot Camp: A Simulation Curriculum and Pilot Study

    Directory of Open Access Journals (Sweden)

    Ahmad Khobrani

    2018-01-01

    Full Text Available Trauma is a leading cause of morbidity and mortality in infants and children worldwide. Trauma education is one of the most commonly reported deficiencies in pediatric emergency medicine (PEM training. In this study, we describe the creation of a pediatric trauma boot camp in which trainees’ basic knowledge, level of confidence, teamwork, and communication skills are assessed. The primary goal of this pilot study was to create a simulation-based pediatric trauma curriculum for PEM fellows and emergency medicine residents utilizing Kern’s curricular conceptual framework. This was a pilot, prospective, single cohort, exploratory, observational study utilizing survey methodology and a convenience sample. The curriculum consisted of a two-day experience that included confidence surveys, a cognitive multiple-choice questionnaire, and formative and summative simulation scenarios. At the conclusion of this intensive simulation-based trauma boot camp participants reported increased confidence and demonstrated significant improvement in the basic knowledge and performance of the management of pediatric trauma cases in a simulated environment.

  16. Psycho-education programme for temporomandibular disorders: a pilot study

    Directory of Open Access Journals (Sweden)

    El Maaytah Mohammed

    2007-03-01

    Full Text Available Abstract Background Temporomandibular disorders (TMDs are by far the most predominant condition affecting the temporomandibular joint (TMJ, however many patients have mild self-limiting symptoms and should not be referred for specialist care. The aim of this pilot study was to develop a simple, cost-effective management programme for TMDs using CD-ROM. 41 patients (age 18–70 participated in this study, patients were divided into three groups: the 1st group were involved in an attention placebo CD-ROM (contain anatomical information about the temporomandibular system, the 2nd group received information on CD-ROM designed to increase their control and self efficacy, while the 3rd group received the same programme of the 2nd group added to it an introduction to self-relaxing techniques followed by audio tape of progressive muscle relaxation exercises. Each of the groups was asked to complete a number of questionnaires on the day of initial consultation and six weeks afterwards. Results The two experimental groups (2nd & 3rd were equally effective in reducing pain, disability and distress, and both were more effective than the attention placebo group (1st, however the experimental groups appeared to have improved at follow-up relative to the placebo-group in terms of disability, pain and depressed mood. Conclusion This pilot study demonstrates the feasibility and acceptability of the design. A full, randomized, controlled trial is required to confirm the efficacy of the interventions developed here.

  17. A randomised double-blind placebo-controlled pilot trial of a combined extract of sage, rosemary and melissa, traditional herbal medicines, on the enhancement of memory in normal healthy subjects, including influence of age.

    Science.gov (United States)

    Perry, N S L; Menzies, R; Hodgson, F; Wedgewood, P; Howes, M-J R; Brooker, H J; Wesnes, K A; Perry, E K

    2018-01-15

    To evaluate for the first time the effects of a combination of sage, rosemary and melissa (Salvia officinalis L., Rosmarinus officinalis L. and Melissa officinalis L.; SRM), traditional European medicines, on verbal recall in normal healthy subjects. To devise a suitable study design for assessing the clinical efficacy of traditional herbal medicines for memory and brain function. Forty-four normal healthy subjects (mean age 61 ± 9.26y SD; m/f 6/38) participated in this study. A double-blind, randomised, placebo-controlled pilot study was performed with subjects randomised into an active and placebo group. The study consisted of a single 2-week term ethanol extract of SRM that was chemically-characterised using high resolution LC-UV-MS/MS analysis. Immediate and delayed word recall were used to assess memory after taking SRM or placebo (ethanol extract of Myrrhis odorata (L.) Scop.). In addition analysis was performed with subjects divided into younger and older subgroups (≤ 62 years mean age n = 26: SRM n = 10, Placebo n = 16; ≥ 63 years n = 19: SRM n = 13, Placebo n = 6). Overall there were no significant differences between treatment and placebo change from baseline for immediate or delayed word recall. However subgroup analysis showed significant improvements to delayed word recall in the under 63 year age group (p memory in healthy subjects under 63 years of age. Short- and long- term supplementation with SRM extract merits more robust investigation as an adjunctive treatment for patients with Alzheimer's disease and in the general ageing population. The study design proved a simple cost effective trial protocol to test the efficacy of herbal medicines on verbal episodic memory, with future studies including broader cognitive assessment. Copyright © 2017 Elsevier GmbH. All rights reserved.

  18. Can Australian general practitioners effectively screen for diabetic retinopathy? A pilot study

    Directory of Open Access Journals (Sweden)

    de Jong Inge C

    2002-03-01

    Full Text Available Abstract Background Diabetes has been identified as one of the national health priority areas in Australia. After 20 years of diabetes most patients can be expected to develop diabetic retinopathy which, if undetected, is likely to cause significant visual loss or blindness. This paper reports on a pilot study aimed to test the ability of Australian GPs to clinically recognise diabetic retinopathy following a brief training intervention. Method 17 GPs from a Brisbane Division of General Practice were recruited to participate in a clinical upskilling intervention pilot. Participant scores on clinical assessments were used to analyse GP sensitivity and specificity in screening for diabetic retinopathy. Results were compared with the NHMRC guidelines for acceptable screening accuracy. Results Ten of the 17 GPs (59% achieved a screening sensitivity of 25% or less in the pre test, three (18% a sensitivity of 50%, and four (23% achieved a sensitivity of ≥ 75%. In the post-test, all seventeen GPs achieved between 50 and 100% sensitivity. In the pre-test, thirteen (76% GPs achieved a screening specificity of less than or equal to 50%, and four (23% a specificity of 75 %. In the post test, four GPs (23% rated a screening specificity of less than 50%, six (35% achieved a specificity of 66%, and seven (41% 100% specificity. Conclusion 24% of GPs met the NHMRC diabetic retinopathy screening criterion prior to the workshop, and 94% following this brief training intervention. Australian GPs are capable of a much more significant role in community screening for diabetic retinopathy.

  19. Feasibility Pilot Study: Training Soft Skills in Virtual Worlds.

    Science.gov (United States)

    Abshier, Patricia

    2012-04-01

    In a world where funding is limited, training for healthcare professionals is turning more and more to distance learning in an effort to maintain a knowledgeable and skilled work force. In 2010, Cicatelli Associates, Inc. began exploring the feasibility of using games and virtual worlds as an alternative means to teach skills-training in a distance-learning environment. The pilot study was conducted with six individuals familiar with general counseling and communication skills used by the healthcare industry to promote behavior change. Participants reported that the venue, although challenging at first, showed great potential for use with healthcare providers, as it allowed for more interaction and activities than traditional Webinars. However, there are significant limitations that must be overcome in order for this healthcare training modality to be utilized on a large scale. These limitations included a lack of microgestures and issues regarding the technology being used. In spite of the limitations, however, the potential use of virtual worlds for the training of healthcare providers exists and should be researched further. This article discusses the need and intended benefits of virtual world training as well as the results and conclusions of the pilot study.

  20. Inspectors' ethical challenges in health care regulation: a pilot study.

    Science.gov (United States)

    Seekles, W; Widdershoven, G; Robben, P; van Dalfsen, G; Molewijk, B

    2017-09-01

    There is an increasing body of research on what kind of ethical challenges health care professionals experience regarding the quality of care. In the Netherlands the Dutch Health Care Inspectorate is responsible for monitoring and regulating the quality of health care. No research exists on what kind of ethical challenges inspectors experience during the regulation process itself. In a pilot study we used moral case deliberation as method in order to reflect upon inspectors' ethical challenges. The objective of this paper is to give an overview of the ethical challenges which health care inspectors encounter in their daily work. A thematic qualitative analysis was performed on cases (n = 69) that were collected from health care inspectors in a moral case deliberation pilot study. Eight themes were identified in health care regulation. These can be divided in two categories: work content and internal collaboration. The work of the health care inspectorate is morally loaded and our recommendation is that some form of ethics support is provided for health care inspectors.

  1. 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.

  2. [Dental caries and early childhood development: a pilot study].

    Science.gov (United States)

    Núñez, F Loreto; Sanz, B Javier; Mejía, L Gloria

    2015-01-01

    To investigate the association between dental caries and early childhood development in 3-year-olds from Talca, Chile. A pilot study with a convenience sample of 3-year-olds from Talca (n = 39) who attend public healthcare centers. Child development was measured by the Psychomotor Development Index (PDI), a screening tool used nationally among pre-school children to assess language development, fine motor skills and coordination areas. Dental caries prevalence was evaluated by decayed, missing, filled teeth (DFMT) and decayed, missing, filled tooth surfaces (DFMS) ceo-d and ceo-s indexes. The children were divided into two groups according to the PDIscore: those with a score of 40 or more were considered developmentally normal (n = 32), and those with a score below 40 were considered as having impaired development (n = 7). The severity of caries (DMFT) was negatively correlated with PDI (r = -0.82), and children with the lowest TEPSI score had the highest DFMT values. The average DMFT in children with normal development was 1.31, and 3.57 for those with impaired development. This pilot study indicates that the severity of dental caries is correlated with early childhood development. Copyright © 2015. Publicado por Elsevier España, S.L.U.

  3. Altered sleep-wake patterns in blindness: a combined actigraphy and psychometric study.

    Science.gov (United States)

    Aubin, S; Gacon, C; Jennum, P; Ptito, M; Kupers, R

    2016-08-01

    Light plays an important role in the synchronization of the internal biological clock and the environmental day/night pattern. Thus, absence of vision is often associated with both increases in reported sleep disturbances and incidence of free-running circadian rhythms. In this study we discuss variability in the sleep-wake pattern between blind and normal-sighted individuals. Thirty-day actigraphy recordings were collected from 11 blind individuals without residual light perception and 11 age- and sex-matched normal-sighted controls. From these recordings, we extracted parameters of sleep and wake, including episodes of rest, day-time and night-time sleep periods, and the number of awakenings throughout sleep. A measure of sleep efficiency was derived from these measures for each night-time sleep episode. We also examined complementary measures of sleep quality, using the Pittsburgh Sleep Quality Index, and chronotype, using the Morningness-Eveningness Questionnaire. Although no group differences were found when averaging over the entire recording period, we found a greater variability throughout the 30-days in both sleep efficiency and timing of the night-time sleep episode in blind participants as compared to sighted control participants. We also confirm previous reports of reduced sleep quality in blind individuals. Notably, the variability in sleep efficiency and in the timing of sleep correlated with the severity of sleep disturbances. The timing and physiology of sleep are strongly dependent on the endogenous circadian phase; therefore, observed findings support the hypothesis of free-running circadian rhythms as a dominant factor for the sleep disturbances experienced in blindness. Copyright © 2016 Elsevier B.V. All rights reserved.

  4. Newly blind persons using virtual environment system in a traditional orientation and mobility rehabilitation program: a case study.

    Science.gov (United States)

    Lahav, Orly; Schloerb, David W; Srinivasan, Mandayam A

    2012-09-01

    This paper presents a virtual reality system (the BlindAid) developed for orientation and mobility training of people who are newly blind. The BlindAid allows users to interact with different virtual structures and objects via auditory and haptic feedback. This case study aims to examine if and how the BlindAid, in conjunction with a traditional rehabilitation programme, can help people who are newly blind develop new orientation and mobility methods. Follow-up research based on this study, with a large experiment and control group, could contribute to the area of orientation and mobility rehabilitation training for the newly blind. The case study research focused on A., a woman who is newly blind, for 17 virtual sessions spanning ten weeks, during the 12 weeks of her traditional orientation and mobility rehabilitation programme. The research was implemented by using virtual environment (VE) exploration and orientation tasks in VE and physical spaces. The research methodology used both qualitative and quantitative methods, including interviews, questionnaire, videotape recording, and user computer logs. The results of this study helped elucidate several issues concerning the contribution of the BlindAid system to the exploration strategies and learning processes experienced by the participant in her encounters with familiar and unfamiliar physical surroundings. [Box: see text].

  5. The effect of Christmas joy on the mood among medical doctors - a randomized, blinded intervention study

    DEFF Research Database (Denmark)

    Ilkjær, Christine; Møller, Marianne Birkebæk; Lauridsen, Mette H

    2016-01-01

    -centre blinded intervention study with crossover at three hospital departments. JN intervention of three days was randomized. Median ± standard deviation was given. The level of significance was p index increased....... CONCLUSION: Christmas atmosphere tended to increase DGH at the morning conferences. JN tended to have an additive effect. JN exposure may be beneficial. FUNDING: The study did not receive any funding. TRIAL REGISTRATION: The trial was not registered and was kept secret for the participants in accordance...

  6. Parental Grief and Marital Issues Aftermath: A Pilot Study

    Directory of Open Access Journals (Sweden)

    Nur Atikah Mohamed Hussin

    2016-06-01

    Full Text Available The death of a child is difficult to the bereaved parents. Literature had associated the loss with marriage disruption. The issues on that the difficulties to communicate, gender-related coping mechanisms and sexual need were discussed as reasons for bereaved parents to have conflict in their relationship. However there is limited knowledge about this issue. A pilot study has been conducted among six bereaved parents. The bereaved parents were Malaysian Muslim bereaved parents. They were interviewed individually to explore the challenges or conflicts that they had experienced after the death of their child. This study revealed that there were situations which bereaved parents described as having difficulties in their relationship. However, this study also revealed that the mutual understanding and respect to each other are the most of important components for bereaved parents to maintain their relationship post-loss. This study suggested the importance of suggesting couple counselling to bereaved parents after the death of their child.

  7. Double-blind, controlled, multicenter study of indobufen versus placebo in patients with intermittent claudication

    DEFF Research Database (Denmark)

    Tönnesen, K H; Albuquerque, P; Baitsch, G

    1993-01-01

    . Adverse events of any type were reported by 18 patients (12.2%) in the indobufen group and by 11 patients (7.2%) in the placebo group. The mechanism whereby the drug is effective in this clinical condition could be related to both its antiplatelet and hemorheologic effects.......The objective of the study was to evaluate the efficacy and safety of indobufen compared with placebo in the treatment of moderately severe intermittent claudication. The study consisted of a four-week single-blind, placebo-controlled run-in phase, followed by a six-month double-blind randomized...... treatment period. A total of 302 patients were allocated to treatment with either placebo (154 patients) or indobufen (148) 200 mg twice daily. The results of the overall intention-to-treat analysis of the study population showed statistically significant superiority of indobufen over placebo after six...

  8. A randomised, double-blinded study comparing giving etoricoxib vs. placebo to female patients with fibromyalgia.

    Science.gov (United States)

    Mahagna, H; Amital, D; Amital, H

    2016-02-01

    Current therapeutic approaches to fibromyalgia syndrome (FMS) do not provide satisfactory pain control to a high percentage of patients. This unmet need constantly fuels the pursuit for new modalities for pain relief. This randomised, double-blind, controlled study assessed the efficacy and safety of adding etoricoxib vs. placebo to the current therapeutic regimen of female patients with FMS. In this double-blind, placebo-controlled study, female patients were randomised to receive either 90 mg etoricoxib once daily or placebo for 6 weeks. Several physical and mental parameters were assessed throughout the study. The primary end-point was the response to treatment, defined as ≥ 30% reduction in the average Brief Pain Inventory score. Secondary outcomes were changes in the Fibromyalgia Impact Questionnaire, SF-36 Quality of Life assessment questionnaire and Hamilton rating scales for anxiety and depression. Overall, 73 patients were recruited. Although many outcome measures improved throughout the study, no difference was recorded between the etoricoxib- and placebo-treated groups. The Brief Pain Inventory, Fibromyalgia Impact Questionnaire, The Hamilton Anxiety and Depression scores did not differ between the two groups. This is the first randomised, double-blind study assessing the effect of adding etoricoxib to pre-existing medications for female patients with FMS. Although being mildly underpowered this study clearly has shown that etoricoxib did not improve pain scores and did not lead to any beneficial mental or physical effects. © 2016 John Wiley & Sons Ltd.

  9. Pilot Study of a Patient-Centered Radiology Process Model.

    Science.gov (United States)

    Swan, J Shannon; Furtado, Vanessa F; Keller, Lisa A; Lotti, Judith Borsody; Saltalamacchia, Catherine A; Lennes, Inga T; Salazar, Gloria M

    2017-02-01

    The Radiology Process Model (RPM) was previously described in terms of its conceptual basis and proposed survey items. The current study describes the first pilot application of the RPM in the field and the results of initial psychometric analysis. We used an Institutional Review Board-approved pilot RPM survey in 100 patients having outpatient interventional radiology procedures. The 24 survey items had 4 or 5 levels of severity. We assessed for missing data, items that patients found confusing, any suggestions by patients for additional items and clarity of items from patient feedback. Factor analysis was performed and internal consistency measured. Construct validity was assessed by correlation of patient responses to the items as a summated scale with a visual analog scale (VAS) they completed indicating their interventional radiology experience. The visual analog scale and the RPM summated scale were strongly correlated (r = 0.7). Factor analysis showed four factors: interactions with facility and doctors/staff, time-sensitive aspects, pain, and anxiety. The items showed high internal consistency (alpha: 0.86) as a group and approximately 0.7 to 0.9 by the factors. Analysis shows that two items could be deleted (cost and communication between radiologist and referrers). Revision of two items and potential addition of others are discussed. The RPM shows initial evidence of psychometric validity and internal consistency reliability. Minor changes are anticipated before wider use. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  10. Using singing to nurture children's hearing? A pilot study.

    Science.gov (United States)

    Welch, Graham F; Saunders, Jo; Edwards, Sian; Palmer, Zoe; Himonides, Evangelos; Knight, Julian; Mahon, Merle; Griffin, Susanna; Vickers, Deborah A

    2015-09-01

    This article reports a pilot study of the potential benefits of a sustained programme of singing activities on the musical behaviours and hearing acuity of young children with hearing impairment (HI). Twenty-nine children (n=12 HI and n=17 NH) aged between 5 and 7 years from an inner-city primary school in London participated, following appropriate ethical approval. The predominantly classroom-based programme was designed by colleagues from the UCL Institute of Education and UCL Ear Institute in collaboration with a multi-arts charity Creative Futures and delivered by an experienced early years music specialist weekly across two school terms. There was a particular emphasis on building a repertoire of simple songs with actions and allied vocal exploration. Musical learning was also supported by activities that drew on visual imagery for sound and that included simple notation and physical gesture. An overall impact assessment of the pilot programme embraced pre- and post-intervention measures of pitch discrimination, speech perception in noise and singing competency. Subsequent statistical data analyses suggest that the programme had a positive impact on participant children's singing range, particularly (but not only) for HI children with hearing aids, and also in their singing skills. HI children's pitch perception also improved measurably over time. Findings imply that all children, including those with HI, can benefit from regular and sustained access to age-appropriate musical activities.

  11. Team Development Measure in Interprofessional Graduate Education: A Pilot Study.

    Science.gov (United States)

    Beebe, Lora Humphrey; Roman, Marian; Skolits, Gary; Raynor, Hollie; Thompson, Dixie; Franks, Andrea

    2018-01-11

    A faculty team developed the 4-week Recovery-Based Interprofessional Distance Education (RIDE) rotation for graduate students in their disciplines. The evaluation team identified the Team Development Measure (TDM) as a potential alternative to reflect team development during the RIDE rotation. The TDM, completed anonymously online, was piloted on the second student cohort (N = 18) to complete the RIDE rotation. The overall pretest mean was 60.73 points (SD = 11.85) of a possible 100 points, indicating that students anticipated their RIDE team would function at a moderately high level during the 4-week rotation. The overall posttest mean, indicating student perceptions of actual team functioning, was 72.71 points (SD = 23.31), an average increase of 11.98 points. Although not statistically significant, Cohen's effect size (d = 0.43) indicates an observed difference of large magnitude. No other published work has used the TDM as a pre-/posttest measure of team development. The authors believe the TDM has several advantages as a measure of student response to interprofessional education offerings, particularly in graduate students with prior experience on health care teams. Further work is needed to validate and extend the findings of this pilot study. [Journal of Psychosocial Nursing and Mental Health Services, xx(x), xx-xx.]. Copyright 2018, SLACK Incorporated.

  12. Autologous bone marrow cell transplantation in acute spinal cord injury--an Indian pilot study.

    Science.gov (United States)

    Chhabra, H S; Sarda, K; Arora, M; Sharawat, R; Singh, V; Nanda, A; Sangodimath, G M; Tandon, V

    2016-01-01

    Phase- I/II, prospective, randomized, single-blind, controlled pilot study. To determine the safety and feasibility of autologous bone marrow transplantation in patients with acute spinal cord injury (SCI) via two routes of transplantation as compared with controls. Indian Spinal Injuries Center, New Delhi. Twenty-one subjects with acute, American Spinal Injury Association Impairment Scale (AIS) A (complete), traumatic SCI with neurological level T1-T12, were recruited and randomized into three groups of seven subjects each. Two groups underwent cell transplantation through the intrathecal or intralesional route, whereas the third served as control. Participants were assessed at baseline and followed up at 6 months and 12-months post enrollment. Safety and tolerability were evaluated by monitoring for any adverse events. Efficacy was assessed through neurological, functional and psychological evaluation, as well as through electrophysiological studies and urodynamics. Surgery was tolerated well by all participants. There were no significant adverse events attributable to the procedure. There was no significant improvement in the neurological, electrophysiological or urodynamic efficacy variables. A statistically significant improvement in functional scores as evaluated by the Spinal Cord Independence Measure and International Spinal Cord Injury Scale was observed in all groups. The procedure is safe and feasible in AIS A participants with thoracic-level injuries at 12-months follow-up. No efficacy could be demonstrated that could be attributed to the procedure.

  13. HandTutor™ enhanced hand rehabilitation after stroke--a pilot study.

    Science.gov (United States)

    Carmeli, Eli; Peleg, Sara; Bartur, Gadi; Elbo, Enbal; Vatine, Jean-Jacques

    2011-12-01

    This study assessed the potential therapeutic benefi t of using HandTutor™ in combination with traditional rehabilitation in a post-stroke sub-acute population. The study compares an experimental group receiving traditional therapy combined with HandTutorTM treatment, against a control group receiving only traditional therapy. An assessor-blinded, randomized controlled pilot trial, was conducted in the Reuth rehabilitation unit in Israel. Thirty-one stroke patients in the sub-acute phase, were randomly assigned to one of the two groups (experimental or control) in sets of three. The experimental group (n = 16) underwent a hand rehabilitation programme using the HandTutorTM combined with traditional therapy. The control group (n = 15) received only traditional therapy. The treatment schedules for both groups were of similar duration and frequency. Improvements were evaluated using three indicators: 1) The Brunnström-Fugl-Meyer (FM) test, 2) the Box and Blocks (B&B) test and 3) improvement parameters as determined by the HandTutorTM software. Following 15 consecutive treatment sessions, a signifi cant improvement was observed within the experimental group (95% confi dence intervals) compared with the control group: B&B p = 0.015; FM p = 0.041, HandTutor™ performance accuracy on x axis and performance accuracy on y axis p hand function rehabilitation.

  14. A pilot study of short-duration sputum pretreatment procedures for optimizing smear microscopy for tuberculosis.

    Directory of Open Access Journals (Sweden)

    Peter Daley

    2009-05-01

    Full Text Available Direct sputum smear microscopy for tuberculosis (TB lacks sensitivity for the detection of acid fast bacilli. Sputum pretreatment procedures may enhance sensitivity. We did a pilot study to compare the diagnostic accuracy and incremental yield of two short-duration (<1 hour sputum pretreatment procedures to optimize direct smears among patients with suspected TB at a referral hospital in India.Blinded laboratory comparison of bleach and universal sediment processing (USP pretreated centrifuged auramine smears to direct Ziehl-Neelsen (ZN and direct auramine smears and to solid (Loweinstein-Jensen (LJ and liquid (BACTEC 460 culture. 178 pulmonary and extrapulmonary TB suspects were prospectively recruited during a one year period. Thirty six (20.2% were positive by either solid or liquid culture. Direct ZN smear detected 22 of 36 cases and direct auramine smears detected 26 of 36 cases. Bleach and USP centrifugation detected 24 cases each, providing no incremental yield beyond direct smears. When compared to combined culture, pretreated smears were not more sensitive than direct smears (66.6% vs 61.1 (ZN or 72.2 (auramine, and were not more specific (92.3% vs 93.0 (ZN or 97.2 (auramine.Short duration sputum pretreatment with bleach and USP centrifugation did not increase yield as compared to direct sputum smears. Further work is needed to confirm this in a larger study and also determine if longer duration pre-treatment might be effective in optimizing smear microscopy for TB.

  15. Reduced motor cortical inhibition in migraine: A blinded transcranial magnetic stimulation study.

    Science.gov (United States)

    Neverdahl, J P; Omland, P M; Uglem, M; Engstrøm, M; Sand, T

    2017-12-01

    To investigate motor cortical excitability, inhibition, and facilitation with navigated transcranial magnetic stimulation (TMS) in migraine in a blinded cross-sectional study. Resting motor threshold (RMT), cortical silent period (CSP), short-interval intracortical inhibition (SICI), and intracortical facilitation (ICF) were compared in 27 interictal migraineurs and 33 controls. 24 female interictal migraineurs and 27 female controls were compared in subgroup analyses. Seven preictal migraineurs were also compared to the interictal group in a hypothesis-generating analysis. Investigators were blinded for diagnosis during recording and analysis of data. SICI was decreased in interictal migraineurs when compared to healthy controls (p=0.013), CSP was shortened in female interictal migraineurs (p=0.041). ICF was decreased in preictal compared to interictal migraineurs (p=0.023). RMT and ICF were not different between interictal migraineurs and controls. Cortical inhibition was decreased in migraineurs between attacks, primarily in a female subgroup, indicating an importance of altered cortical inhibition in migraine. Previous studies on motor cortical excitability in migraineurs have yielded varying results. This relatively large and blinded study provides support for altered cortical inhibition in migraine. Measuring intracortical facilitation in the period preceding migraine attacks may be of interest for future studies. Copyright © 2017 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.

  16. Acupressure for smoking cessation – a pilot study

    Directory of Open Access Journals (Sweden)

    Moody Russell C

    2007-03-01

    Full Text Available Abstract Background Tobacco smoking is a serious risk to health: several therapies are available to assist those who wish to stop. Smokers who approach publicly funded stop-smoking clinics in the UK are currently offered nicotine replacement therapy (NRT or bupropion, and group behaviour therapy, for which there is evidence of effectiveness. Acupuncture and acupressure are also used to help smokers, though a systematic review of the evidence of their effectiveness was inconclusive. The aim of this pilot project was to determine the feasibility of a study to test acupressure as an adjunct to one anti-smoking treatment currently offered, and to inform the design of the study. Methods An open randomised controlled pilot study was conducted within the six week group programme offered by the Smoking Advice Service in Plymouth, UK. All participants received the usual treatment with NRT and group behavioural therapy, and were randomised into three groups: group A with two auricular acupressure beads, group B with one bead, and group C with no additional therapy. Participants were taught to press the beads when they experienced cravings. Beads were worn in one ear for four weeks, being replaced as necessary. The main outcome measures assessed in the pilot were success at quitting (expired CO ≤ 9 ppm, the dose of NRT used, and the rating of withdrawal symptoms using the Mood and Symptoms Scale. Results From 49 smokers attending four clinics, 24 volunteered to participate, 19 attended at least once after quitting, and seven remained to the final week. Participants who dropped out reported significantly fewer previous quit attempts, but no other significant differences. Participants reported stimulating the beads as expected during the initial days after quitting, but most soon reduced the frequency of stimulation. The discomfort caused by the beads was minor, and there were no significant side effects. There were technical problems with adhesiveness of

  17. Single-blind, placebo controlled randomised clinical study of chitosan for body weight reduction

    OpenAIRE

    Trivedi, VR; Satia, MC; Deschamps, A.; Maquet, V.; Shah, RB; Zinzuwadia, PH; Trivedi, JV

    2016-01-01

    Background Chitosan is a dietary fibre which acts by reducing fat absorption and thus used as a means for controlling weight. Weight loss clinical trial outcomes, however, have contradictory results regarding its efficacy. The primary objective of the present study was to evaluate the efficacy and safety of a chitosan from fungal origin in treatment of excess weight in the absence of dietary restrictions. Methods A phase IV, randomised, multicentre, single-blind, placebo-controlled, clinical ...

  18. Consumer-orientated outcomes in discharge planning: a pilot study.

    Science.gov (United States)

    Armitage, S K; Kavanagh, K M

    1998-01-01

    The desired outcome of health care provision can only be known by evaluating care from the perspective of the consumer. An exploratory study was undertaken to develop and evaluate a research instrument (a semistructured telephone interview guide) as a measure of patient outcomes in discharge planning. A sample of 29 patients was recruited from three medical wards of a large tertiary referral teaching hospital in Sydney, Australia. Participants were contacted at home after discharge from hospital and interviewed by telephone. Their perceptions of hospital discharge and continuing care needs were investigated. Preliminary analysis of the data obtained in the pilot study demonstrated that there were deficiencies in hospital discharge procedures which impacted on continuing care and that patients can contribute useful information for evaluating and improving discharge planning.

  19. A Spanish Pilot Investigation for a Crosslinguistic Study in Protracted Phonological Development

    Science.gov (United States)

    Chavez-Peon, Mario E.; Bernhardt, Barbara May; Adler-Bock, Marcy; Avila, Carmen; Carballo, Gloria; Fresneda, Dolores; Lleo, Conxita; Mendoza, Elvira; Perez, Denisse; Stemberger, Joseph Paul

    2012-01-01

    A crosslinguistic study is underway concerning children's protracted phonological development (i.e. speech sound disorders). The current article reports pilot Spanish data for this study from two 4-year-old boys with protracted phonological development. The purposes of the pilot study were to: (1) develop and evaluate a word list for elicitation…

  20. Deep TMS on alcoholics: effects on cortisolemia and dopamine pathway modulation. A pilot study.

    Science.gov (United States)

    Ceccanti, Marco; Inghilleri, Maurizio; Attilia, Maria Luisa; Raccah, Ruggero; Fiore, Marco; Zangen, Abraham; Ceccanti, Mauro

    2015-04-01

    The hypothalamic pituitary adrenal axis and dopamine have a key role in transition from alcohol social use to addiction. The medial prefrontal cortex was shown to modulate dopaminergic activity and cortisol releasing factor (CRF) release in hypothalamic and extra-hypothalamic systems. The recent advancements in non-invasive neurostimulation technologies has enabled stimulation of deeper brain regions using H-coil transcranial magnetic stimulation (TMS) in humans. This randomized double-blind placebo-controlled pilot study aims to evaluate H-coil efficacy in stimulating the medial prefrontal cortex. Cortisolemia and prolactinemia were evaluated as effectiveness markers. Alcohol intake and craving were considered as secondary outcomes. Eighteen alcoholics were recruited and randomized into 2 homogeneous groups: 9 in the real stimulation group and 9 in the sham stimulation group. Repetitive TMS (rTMS) was administered through a magnetic stimulator over 10 sessions at 20 Hz, directed to the medial prefrontal cortex. rTMS significantly reduced blood cortisol levels and decreased prolactinemia, thus suggesting dopamine increase. Craving visual analogic scale (VAS) in treated patients decreased, as well as mean number of alcoholic drinks/day and drinks on days of maximum alcohol intake (DMAI). In the sham group there was no significant effect observed on cortisolemia, prolactinemia, mean number of alcoholic drinks/day, or drinks/DMAI. Thus, deep rTMS could be considered a potential new treatment for alcoholism.

  1. 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.

  2. Contributions of auriculotherapy in smoking cessation: a pilot study

    Directory of Open Access Journals (Sweden)

    Roberta de Paiva Silva

    2014-10-01

    Full Text Available Objective To evaluate the contribution of auriculotherapy in smoking cessation. Method Double-blind randomized controlled trial, conducted with 30 smokers allocated into two groups: Experimental Group (21 participants received 10 sessions of auriculotherapy at specific points for smoking and Control Group (nine participants received auriculotherapy in points that have no effect on the focus of research. Results Auriculotherapy contributed in reducing the number of cigarettes smoked in 61.9% of participants (p=0.002, in reducing the difficult to abstain from smoking in places where it is forbidden by 38% (p=0.050 and in not smoking when ill 23.8% (p=0.025. Conclusion Given the efficacy only in terms of reducing the number of cigarettes smoked and other parameters, we suggest that future studies consider the use of auriculotherapy combined with other treatment methods, in order to achieve better results in cessation/abstinence.

  3. Lifestyle in Visually Impaired or Blind Massage Therapists: A Preliminary Study.

    Science.gov (United States)

    Hung, Shu-Ling; Chen, Mei-Fang; Lin, Yu-Hua; Kao, Chia-Chan; Chang, Ya-Wen; Chan, Hui-Shan

    2017-11-09

    Lifestyle is among the most important factors affecting individual health status. Limited access to health information may limit the ability of people with visual impairment or blindness to practice healthy lifestyles. However, no studies have investigated how lifestyle practices affect health specifically in visually impaired and blind populations. The aim of this study was to investigate the lifestyle behaviors of visually impaired and blind massage therapists (VIBMTs) in Taiwan. This exploratory study used a purposive sampling technique to recruit 50 VIBMTs who were employed at massage stations in southern Taiwan. All of the participants completed the Health-Promoting Lifestyle Profile II (HPLP-II) and a survey of demographic characteristics. Descriptive and inferential statistical tests, including the Mann-Whitney U test and the Kruskal-Wallis H test, were used. Statistical significance was defined as p visually impaired populations. The low scores for nutrition may be improved by establishing nutrition education programs that are designed specifically for VIBMTs to increase their consumption of fresh produce and other healthy foods and by requiring food manufacturers to use labels that may be easily read or understood by visually impaired populations.

  4. 'Birth to Ten' - pilot studies to test the feasibility of a birth cohort study ...

    African Journals Online (AJOL)

    Birth to Ten' is a birth cohort study currently being conducted in the Johannesburg-Soweto area. This paper describes the various pilot studies that were undertaken to investigate the feasibility of a cohort study in an urban area. These studies were designed to determine the monthly birth rate, the timing, frequency and ...

  5. A double-blind, randomized, placebo-controlled pilot study to investigate the effects of finasteride combined with a biodegradable self-reinforced poly L-lactic acid spiral stent in patients with urinary retention caused by bladder outlet obstruction from benign prostatic hyperplasia.

    Science.gov (United States)

    Isotalo, T; Talja, M; Hellström, P; Perttilä, I; Välimaa, T; Törmälä, P; Tammela, T L

    2001-07-01

    To assess whether patients in acute urinary retention from benign prostatic enlargement can be treated with a combined therapy comprising finasteride and a bioabsorbable self-reinforced poly L-lactic acid (SR-PLLA) urethral stent. Fifty-five patients in acute urinary retention were treated as outpatients; they had a suprapubic catheter inserted and the SR-PLLA stent placed cystoscopically. After 2 weeks the patients were randomized to receive either finasteride 5 mg daily or placebo. They were assessed at baseline and at 6, 12 and 18 months for maximum urinary flow rate, prostate volume and serum prostate-specific antigen (PSA). Nineteen patients completed the study while 36 discontinued. There was a statistically significant increase in the mean maximum flow rate, and a statistically significant decrease in the prostatic volume and serum PSA in the finasteride group. The same number of patients discontinued in both groups; the major reason for discontinuation was insufficient therapeutic response. The major problems were discontinuation of treatment because the response to therapy was insufficient, and uncontrolled breakdown of the spiral stent. To solve these problems, new configurations of bioabsorbable stents are needed.

  6. A double-blind randomized pilot trial comparing computerized cognitive exercises to Tetris in adolescents with attention-deficit/hyperactivity disorder

    DEFF Research Database (Denmark)

    Bikic, Aida; Christensen, Torben Østergaard; Leckman, James F.

    2017-01-01

    ). METHOD: Eighteen adolescents with ADHD were randomized to treatment or control intervention for 7 weeks. Outcome measures were cognitive test, symptom, and motivation questionnaires. RESULTS: 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......BACKGROUND: 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...

  7. Social media in adolescent health literacy education: a pilot study.

    Science.gov (United States)

    Tse, Carrie Kw; Bridges, Susan M; Srinivasan, Divya Parthasarathy; Cheng, Brenda Ss

    2015-03-09

    While health literacy has gained notice on a global stage, the initial focus on seeking associations with medical conditions may have overlooked its impact across generations. Adolescent health literacy, specifically in dentistry, is an underexplored area despite the significance of this formative stage on an individual's approach to healthy lifestyles and behaviors. The aim is to conduct a pilot study to evaluate the efficacy of three major social media outlets - Twitter, Facebook, and YouTube - in supporting adolescents' oral health literacy (OHL) education. A random sample of 22 adolescents (aged 14-16 years) from an English-medium international school in Hong Kong provided informed consent. Sociodemographic information, including English language background, social media usage, and dental experience were collected via a questionnaire. A pre- and post-test of OHL (REALD-30) was administered by two trained, calibrated examiners. Following pre-test, participants were randomly assigned to one of three social media outlets: Twitter, Facebook, or YouTube. Participants received alerts posted daily for 5 consecutive days requiring online accessing of modified and original OHL education materials. One-way ANOVA ( analysis of variance) was used to compare the mean difference between the pre- and the post-test results among the three social media. No associations were found between the social media allocated and participants' sociodemographics, including English language background, social media usage, and dental experience. Of the three social media, significant differences in literacy assessment scores were evident for participants who received oral health education messages via Facebook (P=.02) and YouTube (P=.005). Based on the results of the pilot study, Facebook and YouTube may be more efficient media outlets for OHL promotion and education among adolescent school children when compared to Twitter. Further analyses with a larger study group is warranted.

  8. The Effect of Rubric-Guided, Focused, Personalized Coaching Sessions and Video-Recorded Presentations on Teaching Skills Among Fourth-Year Medical Students: A Pilot Study.

    Science.gov (United States)

    Tchekmedyian, Vatche; Shields, Helen M; Pelletier, Stephen R; Pazo, Valeria C

    2017-11-01

    As medical students become residents, teaching becomes an expected and integral responsibility. Yet, training-for-teaching opportunities are lacking. In 2014, the authors designed a pilot study using rubric-guided, focused, personalized coaching sessions and video-recorded presentations to improve student teaching skills among fourth-year students at Harvard Medical School. In 2014-2015, the authors recruited students from an elective on how to tutor preclinical students for the pilot, which consisted of four phases: a precoaching teaching presentation, a 30- to 45-minute coaching session, a postcoaching teaching presentation, and blinded reviewer ratings. Students' pre- and postcoaching presentations were video recorded. Using a scoring rubric for 15 teaching skills, students rated their pre- and postcoaching videos. Blinded reviewers also rated the pre- and postcoaching presentations using the same rubric with an additional category to gauge their overall impression. Fourteen students completed all four phases of the pilot. Students' ratings demonstrated statistically significant improvement in several teaching skills, including presentation content (P teaching skills, including opening statement and learning objectives (P teaching settings, addressing the interventions' generalizability, training coaches, and performing additional evaluations.

  9. Effects of aquajogging in obese adults: a pilot study.

    Science.gov (United States)

    Wouters, Eveline J M; Van Nunen, Annemieke M A; Geenen, Rinie; Kolotkin, Ronette L; Vingerhoets, Ad J J M

    2010-01-01

    Aim and Method. To examine in obese people the potential effectiveness of a six-week, two times weekly aquajogging program on body composition, fitness, health-related quality of life, and exercise beliefs. Fifteen otherwise healthy obese persons participated in a pilot study. Results. Total fat mass and waist circumference decreased 1.4 kg (P = .03) and 3.1 cm (P = .005), respectively. The distance in the Six-Minute Walk Test increased 41 meters (P = .001). Three scales of the Impact of Weight on Quality of Life-Lite questionnaire improved: physical function (P = .008), self-esteem (P = .004), and public distress (P = .04). Increased perceived exercise benefits (P = .02) and decreased embarrassment (P = .03) were observed. Conclusions. Aquajogging was associated with reduced body fat and waist circumference and improved aerobic fitness and quality of life. These findings suggest the usefulness of conducting a randomized controlled trial with long-term outcome assessments.

  10. Concurrent chemoradiotherapy for advanced cervical cancer. A pilot study

    International Nuclear Information System (INIS)

    Kodama, Junichi; Hashimoto, Ichiro; Seki, Noriko; Hongo, Atsushi; Mizutani, Yasushi; Miyagi, Yasunari; Yoshinouchi, Mitsuo; Kudo, Takafumi

    2001-01-01

    Recently, attempts have made to use radiotherapy in combination with chemotherapy in various solid tumors including cervical cancer. Twenty-four patients with locally advanced cervical cancer were treated with concurrent Carboplatin (16-24 mg/m 2 /day) or Nedaplatin (20 mg/m 2 /week) and conventional radiotherapy. Of 13 evaluable patients, there were nine complete responders and four partial responders. There was no renal damage or grade 4 hematological toxicity. Gastrointestinal adverse reactions were mild. One patient had grade 3 dermatologic toxicity after delayed radiation therapy. This pilot study suggests that daily Carboplatin or weekly Nedaplatin administered with standard radiation therapy is safe, well-tolerated, and thus may be useful as a radiation sensitizer in the treatment of locally advanced cervical cancer. (author)

  11. A Pilot Study of Mindfulness Meditation for Pediatric Chronic Pain

    Directory of Open Access Journals (Sweden)

    Lynn C. Waelde

    2017-04-01

    Full Text Available Despite advances in psychological interventions for pediatric chronic pain, there has been little research examining mindfulness meditation for these conditions. This study presents data from a pilot clinical trial of a six-week manualized mindfulness meditation intervention offered to 20 adolescents aged 13–17 years. Measures of pain intensity, functional disability, depression and parent worry about their child’s pain were obtained at baseline and post-treatment. Results indicated no significant changes in pain or depression, however functional disability and frequency of pain functioning complaints improved with small effect sizes. Parents’ worry about child’s pain significantly decreased with a large effect size. Participants rated intervention components positively and most teens suggested that the number of sessions be increased. Three case examples illustrate mindfulness meditation effects and precautions. Mindfulness meditation shows promise as a feasible and acceptable intervention for youth with chronic pain. Future research should optimize intervention components and determine treatment efficacy.

  12. A Postpartum Sleep and Fatigue Intervention Feasibility Pilot Study.

    Science.gov (United States)

    Doering, Jennifer J; Dogan, Sirin

    2018-01-01

    The purpose of this pilot study was to evaluate the feasibility, acceptability, and cost of a self-management intervention for postpartum fatigue and sleep in socioeconomically disadvantaged urban women. Helping U Get Sleep (HUGS) is a theory-guided intervention developed from the Individual and Family Self-Management Theory. Medicaid-enrolled participants in the United States were recruited from an inpatient postpartum unit. Treatment and attention control interventions were delivered (15 HUGS, 12 comparison) at a week 3 postpartum home visit and 4 follow-up phone calls. Over the 9-week protocol, the HUGS group demonstrated significant improvements in subjective fatigue and subjective sleep disturbance relative to the comparison group. The HUGS intervention was feasible and acceptable, delivered on average, in 100 min and costing US$79 per participant.

  13. Impact of nutrition messages on children's food choice: pilot study.

    Science.gov (United States)

    Bannon, Katie; Schwartz, Marlene B

    2006-03-01

    This pilot study tested the influence of nutrition message framing on snack choice among kindergarteners. Three classrooms were randomly assigned to watch one of the following 60s videos: (a) a gain-framed nutrition message (i.e. the positive benefits of eating apples) (n=14); (b) a loss-framed message (i.e. the negative consequences of not eating apples) (n=18); or (c) a control scene (children playing a game) (n=18). Following this, the children were offered a choice between animal crackers and an apple for their snack. Among the children who saw one of the nutrition message videos, 56% chose apples rather than animal crackers; in the control condition only 33% chose apples. This difference was statistically significant (chi2=7.56, p<0.01). These results suggest that videos containing nutritional messages may have a positive influence on children's short-term food choices.

  14. Familial Paraphilia: A Pilot Study with the Construction of Genograms

    Science.gov (United States)

    Labelle, Alain; Bourget, Dominique; Bradford, John M. W.; Alda, Martin; Tessier, Pierre

    2012-01-01

    Biological factors are likely predisposing and modulating elements in sexually deviant behavior. The observation that paraphilic behavior tends to cluster in some families is intriguing and potentially raises questions as to whether shared genetic factors may play a role in the transmission of paraphilia. This pilot study introduces five families in which we found presence of paraphilia over generations. We constructed genograms on the basis of a standardized family history. Results document the aggregation of sexual deviations within the sample of families and support a clinical/phenomenological heterogeneity of sexual deviation. The concept of paraphilia in relation to phenotypic expressions and the likelihood of a spectrum of related disorders must be clarified before conclusions can be reached as to family aggregation of paraphilia based on biological factors. PMID:23738209

  15. Entrepreneurial behavior among employees. Pilot study: Employees from Bucharest

    Directory of Open Access Journals (Sweden)

    Ionuţ Constantin

    2015-12-01

    Full Text Available Many objective or subjective factors influence the decision to open a business. The most important factors are: the existence of an adequate opportunity or a market, perception that starting a business could be difficult because of bureaucracy, financial barriers or the need to acquire new skills, a lack of money, etc. Also, entrepreneurial behavior is generally influenced by socio-economic status of the family of origin [1]. Thus, children from wealthy families have the “competitive advantage” to receive an education appropriate for managing a business and of course have the necessary financial resources and its start [2]. However, abilities of every individual can “correct’’ these benefits are completely eliminated/reduced exogenous barriers [3]. In this article I will present the results of a pilot study conducted in 2014 at Bucharest employees to observe their entrepreneurial behavior.

  16. A Pilot Study on Measuring Customer’s Satisfaction Level

    Directory of Open Access Journals (Sweden)

    Vide Boltez

    2013-01-01

    Full Text Available RQ: Determine the level of customer satisfaction of a company’s products and services to obtain information on needed improvements.Purpose: The purpose of measuring customer’s satisfaction level is to obtain information directly from the final buyer that bought our product. The next step is to analyze the information obtained and to take the results into consideration to improve the working process in production and in other departments of the company.Method: The method used for the pilot study to measure customer satisfaction was a short questionnaire that was given to 10 customers of our product and 10 completed questionnaires were obtained.Results: The results showed the level of satisfaction of final buyers of roof tiles and roofs that the company has achieved through their products and services. The results facilitate the production, logistics, purchasing and sales department to obtain information on positive satisfaction levels and areas that need change. At the same time, the final buyer was identified (i.e., name, surname, address, and so forth, which up until now had not been.Organization: The organization will save time and money in the future, because it will continuously measure customer satisfaction to improve production and other departments in the organization towards creating satisfied customers.Society: Final buyers of roofs are, and will be, more satisfied with their decisions, because the organization carries out after-sales satisfaction levels.Originality: The research was original, because up to this date the organization has not conducted research in such a manner.Limitations: The pilot study used 10 completed questionnaires that represent a very small sample to make any generalizations.

  17. Quantification of Forces During a Neurosurgical Procedure: A Pilot Study.

    Science.gov (United States)

    Gan, Liu Shi; Zareinia, Kourosh; Lama, Sanju; Maddahi, Yaser; Yang, Fang Wei; Sutherland, Garnette R

    2015-08-01

    Knowledge of tool-tissue interaction is mostly taught and learned in a qualitative manner because a means to quantify the technical aspects of neurosurgery is currently lacking. Neurosurgeons typically require years of hands-on experience, together with multiple initial trial and error, to master the optimal force needed during the performance of neurosurgical tasks. The aim of this pilot study was to develop a novel force-sensing bipolar forceps for neurosurgery and obtain preliminary data on specific tasks performed on cadaveric brains. A novel force-sensing bipolar forceps capable of measuring coagulation and dissection forces was designed and developed by installing strain gauges along the length of the bipolar forceps prongs. The forceps was used in 3 cadaveric brain experiments and forces applied by an experienced neurosurgeon for 10 surgical tasks across the 3 experiments were quantified. Maximal peak (effective) forces of 1.35 N and 1.16 N were observed for dissection (opening) and coagulation (closing) tasks, respectively. More than 70% of forces applied during the neurosurgical tasks were less than 0.3 N. Mean peak forces ranged between 0.10 N and 0.41 N for coagulation of scalp vessels and pia-arachnoid, respectively, and varied from 0.16 N for dissection of small cortical vessel to 0.65 N for dissection of the optic chiasm. The force-sensing bipolar forceps were able to successfully measure and record real-time tool-tissue interaction throughout the 3 experiments. This pilot study serves as a first step toward quantification of tool-tissue interaction forces in neurosurgery for training and improvement of instrument handling skills. Copyright © 2015 Elsevier Inc. All rights reserved.

  18. The Nonuse, Misuse, and Proper Use of Pilot Studies in Experimental Evaluation Research

    Science.gov (United States)

    Westlund, Erik; Stuart, Elizabeth A.

    2017-01-01

    This article discusses the nonuse, misuse, and proper use of pilot studies in experimental evaluation research. The authors first show that there is little theoretical, practical, or empirical guidance available to researchers who seek to incorporate pilot studies into experimental evaluation research designs. The authors then discuss how pilot…

  19. Bovine Colostrum to Children With Short Bowel Syndrome: A Randomized, Double-Blind, Crossover Pilot Study

    DEFF Research Database (Denmark)

    Aunsholt, L.; Jeppesen, Palle Bekker; Lund, P.

    2014-01-01

    Background: Management of short bowel syndrome (SBS) aims to achieve intestinal autonomy to prevent fluid, electrolyte, and nutrient deficiencies and maintain adequate development. Remnant intestinal adaptation is required to obtain autonomy. In the newborn pig, colostrum has been shown to support...... of enteral fluid intake was replaced with bovine colostrum or a mixed milk diet for 4 weeks, separated by a 4-week washout period. Intestinal absorption of energy and wet weight was used to assess intestinal function and the efficacy of colostrum. Results: Colostrum did not improve energy or wet weight...

  20. A novel magnetic stimulator increases experimental pain tolerance in healthy volunteers - a double-blind sham-controlled crossover study.

    Directory of Open Access Journals (Sweden)

    Rudie Kortekaas

    Full Text Available UNLABELLED: The 'complex neural pulse'(TM (CNP is a neuromodulation protocol employing weak pulsed electromagnetic fields (PEMF. A pioneering paper reported an analgesic effect in healthy humans after 30 minutes of CNP-stimulation using three nested whole head coils. We aimed to devise and validate a stimulator with a novel design entailing a multitude of small coils at known anatomical positions on a head cap, to improve applicability. The main hypothesis was that CNP delivery with this novel device would also increase heat pain thresholds. Twenty healthy volunteers were enrolled in this double-blind, sham-controlled, crossover study. Thirty minutes of PEMF (CNP or sham was applied to the head. After one week the other treatment was given. Before and after each treatment, primary and secondary outcomes were measured. Primary outcome was heat pain threshold (HPT measured with thermal quantitative sensory testing. Other outcomes were warmth detection threshold, and aspects of cognition, emotion and motor performance. As hypothesized heat pain threshold was significantly increased after the PEMF stimulation. All other outcomes were unaltered by the PEMF but there was a trend level reduction of cognitive performance after PEMF stimulation as measured by the digit-symbol substitution task. Results from this pilot study suggest that our device is able to stimulate the brain and to modulate its function. This is in agreement with previous studies that used similar magnetic field strengths to stimulate the brain. Specifically, pain control may be achieved with PEMF and for this analgesic effect, coil design does not appear to play a dominant role. In addition, the flexible configuration with small coils on a head cap improves clinical applicability. TRIAL REGISTRATION: Dutch Cochrane Centre NTR1093.

  1. A Novel Magnetic Stimulator Increases Experimental Pain Tolerance in Healthy Volunteers - A Double-Blind Sham-Controlled Crossover Study

    Science.gov (United States)

    Kortekaas, Rudie; Konopka, Karl-Heinz; Harbers, Marten; van der Hoeven, Johannes H.; van Wijhe, Marten; Aleman, André; Maurits, Natasha M.

    2013-01-01

    The ‘complex neural pulse’TM (CNP) is a neuromodulation protocol employing weak pulsed electromagnetic fields (PEMF). A pioneering paper reported an analgesic effect in healthy humans after 30 minutes of CNP-stimulation using three nested whole head coils. We aimed to devise and validate a stimulator with a novel design entailing a multitude of small coils at known anatomical positions on a head cap, to improve applicability. The main hypothesis was that CNP delivery with this novel device would also increase heat pain thresholds. Twenty healthy volunteers were enrolled in this double-blind, sham-controlled, crossover study. Thirty minutes of PEMF (CNP) or sham was applied to the head. After one week the other treatment was given. Before and after each treatment, primary and secondary outcomes were measured. Primary outcome was heat pain threshold (HPT) measured with thermal quantitative sensory testing. Other outcomes were warmth detection threshold, and aspects of cognition, emotion and motor performance. As hypothesized heat pain threshold was significantly increased after the PEMF stimulation. All other outcomes were unaltered by the PEMF but there was a trend level reduction of cognitive performance after PEMF stimulation as measured by the digit-symbol substitution task. Results from this pilot study suggest that our device is able to stimulate the brain and to modulate its function. This is in agreement with previous studies that used similar magnetic field strengths to stimulate the brain. Specifically, pain control may be achieved with PEMF and for this analgesic effect, coil design does not appear to play a dominant role. In addition, the flexible configuration with small coils on a head cap improves clinical applicability. Trial Registration Dutch Cochrane Centre NTR1093 PMID:23620795

  2. A pilot study of a Medication Rationalization (MERA) intervention.

    Science.gov (United States)

    Whitty, Rachel; Porter, Sandra; Battu, Kiran; Bhatt, Pranjal; Koo, Ellen; Kalocsai, Csilla; Wu, Peter; Delicaet, Kendra; Bogoch, Isaac I; Wu, Robert; Downar, James

    2018-02-16

    Many seriously ill and frail inpatients receive potentially inappropriate or harmful medications and do not receive medications for symptoms of advanced illness. We developed and piloted an interprofessional Medication Rationalization (MERA) approach to deprescribing inappropriate medications and prescribing appropriate comfort medications. We conducted a single-centre pilot study of inpatients at risk of 6-month mortality from advanced age or morbidity. The MERA team reviewed the patients' medications and made recommendations on the basis of guidelines. We measured end points for feasibility, acceptability, efficiency and effectiveness. We enrolled 61 of 115 (53%) eligible patients with a mean age of 79.6 years (standard deviation [SD] 11.7 yr). Patients were taking an average of 11.5 (SD 5.2) medications before admission and had an average of 2.1 symptoms with greater than 6/10 severity on the revised Edmonton Symptom Assessment System. The MERA team recommended 263 medication changes, of which 223 (85%) were accepted by both the medical team and the patient. MERA team's recommendations resulted in the discontinuation of 162 medications (mean 3.1 per patient), dose changes for 48 medications (mean 0.9 per patient) and the addition of 13 medications (mean 0.2 per patient). Patients who received the MERA intervention stopped significantly more inappropriate medications than similar non-MERA comparison patients for whom data were collected retrospectively (3.1 v. 0.9 medications per patient, p < 0.01). The MERA approach was highly acceptable to patients and medical team members. The MERA intervention is feasible, acceptable, efficient and possibly effective for changing medication use among seriously ill and frail elderly inpatients. Scalability and effectiveness may be improved through automation and integration with medication reconciliation programs. Copyright 2018, Joule Inc. or its licensors.

  3. Clinical relevance of IgG antibodies against food antigens in Crohn's disease: a double-blind cross-over diet intervention study.

    Science.gov (United States)

    Bentz, S; Hausmann, M; Piberger, H; Kellermeier, S; Paul, S; Held, L; Falk, W; Obermeier, F; Fried, M; Schölmerich, J; Rogler, G

    2010-01-01

    Environmental factors are thought to play an important role in the development of Crohn's disease (CD). Immune responses against auto-antigens or food antigens may be a reason for the perpetuation of inflammation. In a pilot study, 79 CD patients and 20 healthy controls were examined for food immunoglobulin G (IgG). Thereafter, the clinical relevance of these food IgG antibodies was assessed in a double-blind cross-over study with 40 patients. Based on the IgG antibodies, a nutritional intervention was planned. The interferon (IFN)gamma secretion of T cells was measured. Eosinophil-derived neurotoxin was quantified in stool. The pilot study resulted in a significant difference of IgG antibodies in serum between CD patients and healthy controls. In 84 and 83% of the patients, respectively, IgG antibodies against processed cheese and yeast were detected. The daily stool frequency significantly decreased by 11% during a specific diet compared with a sham diet. Abdominal pain reduced and general well-being improved. IFNgamma secretion of T cells increased. No difference for eosinophil-derived neurotoxin in stool was detected. A nutritional intervention based on circulating IgG antibodies against food antigens showed effects with respect to stool frequency. The mechanisms by which IgG antibodies might contribute to disease activity remain to be elucidated.

  4. Does coffee enriched with chlorogenic acids improve mood and cognition after acute administration in healthy elderly? A pilot study.

    Science.gov (United States)

    Cropley, Vanessa; Croft, Rodney; Silber, Beata; Neale, Chris; Scholey, Andrew; Stough, Con; Schmitt, Jeroen

    2012-02-01

    Caffeine exerts positive effects on cognitive and behavioral processes, especially in sub-optimal conditions when arousal is low. Apart from caffeine, coffee contains other compounds including the phenolic compounds ferulic acid, caffeic acid, and the chlorogenic acids, which have purported antioxidant properties. The chlorogenic acids are the most abundant family of compounds found in coffee, yet their effects on cognition and mood have not been investigated. This study aims to ascertain whether a coffee rich in chlorogenic acid modulates brain function. The present pilot study examined the acute effects of decaffeinated coffee with regular chlorogenic acid content and decaffeinated coffee with high chlorogenic acid content on mood and cognitive processes, as measured by behavioral tasks and event-related potentials (ERPs). Performance and ERP responses to a battery of cognitive tasks were recorded at baseline and following the equivalent of three cups of coffee in a randomized, double-blind, crossover study of 39 healthy older participants. Compared with the decaffeinated coffee with regular chlorogenic acid and placebo, caffeinated coffee showed a robust positive effect on higher-level mood and attention processes. To a lesser extent, the decaffeinated coffee high in chlorogenic acid also improved some mood and behavioral measures, relative to regular decaffeinated coffee. Our pilot results suggest that non-caffeine compounds in coffee such as the chlorogenic acids may be capable of exerting some acute behavioral effects, thus warranting further investigation.

  5. Desloratadine and levocetirizine improve nasal symptoms, airflow, and allergic inflammation in patients with perennial allergic rhinitis: a pilot study.

    Science.gov (United States)

    Ciprandi, Giorgio; Cirillo, Ignazio; Vizzaccaro, Andrea; Civardi, Elisa; Barberi, Salvatore; Allen, Michela; Marseglia, Gian Luigi

    2005-12-01

    Nasal obstruction is the main symptom in patients with perennial allergic rhinitis. Some new antihistamines have been demonstrated to be capable of improving this symptom. The aim of this pilot study was to evaluate nasal symptoms, nasal airflow, eosinophils, and IL-4 in patients with perennial allergic rhinitis, before and after treatment with two new antihistamines: desloratadine and levocetirizine. Thirty patients with perennial allergic rhinitis were evaluated, 26 males and 4 females (mean age 26+/-7.1 years). All of them received either desloratadine (5 mg/daily) or levocetirizine (5 mg/daily) or placebo for 4 weeks. The study was double-blind, parallel-group, placebo-controlled, and randomized. Total symptom score (including: rhinorrhea, nasal itching, sneezing, and nasal obstruction) was assessed before and after treatment. Rhinomanometry and decongestion test, nasal lavage, and nasal scraping were performed in all subjects before and after treatment. Eosinophils were counted by conventional staining; IL-4 was measured by immunoassay of fluids recovered from nasal lavage. Desloratadine and levocetirizine treatment induced significant symptom relief and significant reduction of IL-4. Both antihistamines significantly affected all parameters in comparison with placebo. This pilot study demonstrates the effectiveness of antihistaminic treatment in: i) relieving nasal symptoms, including obstruction, ii) improving nasal airflow, iii) exerting decongestant activity, iv) reducing eosinophil infiltration, and v) diminishing IL-4 levels.

  6. A double-blind, randomized, placebo-controlled pilot trial to determine the efficacy and safety of ibudilast, a potential glial attenuator, in chronic migraine

    Directory of Open Access Journals (Sweden)

    Kwok YH

    2016-10-01

    Full Text Available Yuen H Kwok,1 James E Swift,1 Parisa Gazerani,2 Paul Rolan1 1Discipline of Pharmacology, University of Adelaide, Level 5 Medical School North, South Australia, Australia; 2Department of Health Science & Technology, Aalborg University, Aalborg, Denmark Background: Chronic migraine (CM is problematic, and there are few effective treatments. Recently, it has been hypothesized that glial activation may be a contributor to migraine; therefore, this study investigated whether the potential glial inhibitor, ibudilast, could attenuate CM. Methods: The study was of double-blind, randomized, placebo-controlled, two-period crossover design. Participants were randomized to receive either ibudilast (40 mg twice daily or placebo treatment for 8 weeks. Subsequently, the participants underwent a 4-week washout period followed by a second 8-week treatment block with the alternative treatment. CM participants completed a headache diary 4 weeks before randomization throughout both treatment periods and 4 weeks after treatment. Questionnaires assessing quality of life and cutaneous allodynia were collected on eight occasions throughout the study. Results: A total of 33 participants were randomized, and 14 participants completed the study. Ibudilast was generally well tolerated with mild, transient adverse events, principally nausea. Eight weeks of ibudilast treatment did not reduce the frequency of moderate to severe headache or of secondary outcome measures such as headache index, intake of symptomatic medications, quality of life or change in cutaneous allodynia. Conclusion: Using the current regimen, ibudilast does not improve migraine with CM participants. Keywords: chronic migraine, glia, ibudilast, headache, immune system

  7. A Component-Based Study of the Effect of Diameter on Bond and Anchorage Characteristics of Blind-Bolted Connections.

    Directory of Open Access Journals (Sweden)

    Muhammad Nasir Amin

    Full Text Available Structural hollow sections are gaining worldwide importance due to their structural and architectural advantages over open steel sections. The only obstacle to their use is their connection with other structural members. To overcome the obstacle of tightening the bolt from one side has given birth to the concept of blind bolts. Blind bolts, being the practical solution to the connection hindrance for the use of hollow and concrete filled hollow sections play a vital role. Flowdrill, the Huck High Strength Blind Bolt and the Lindapter Hollobolt are the well-known commercially available blind bolts. Although the development of blind bolts has largely resolved this issue, the use of structural hollow sections remains limited to shear resistance. Therefore, a new modified version of the blind bolt, known as the "Extended Hollo-Bolt" (EHB due to its enhanced capacity for bonding with concrete, can overcome the issue of low moment resistance capacity associated with blind-bolted connections. The load transfer mechanism of this recently developed blind bolt remains unclear, however. This study uses a parametric approach to characterising the EHB, using diameter as the variable parameter. Stiffness and load-carrying capacity were evaluated at two different bolt sizes. To investigate the load transfer mechanism, a component-based study of the bond and anchorage characteristics was performed by breaking down the EHB into its components. The results of the study provide insight into the load transfer mechanism of the blind bolt in question. The proposed component-based model was validated by a spring model, through which the stiffness of the EHB was compared to that of its components combined. The combined stiffness of the components was found to be roughly equivalent to that of the EHB as a whole, validating the use of this component-based approach.

  8. Mortality in blind subjects. A population-based study on social security files from Baden-Württemberg.

    Science.gov (United States)

    Krumpaszky, H G; Dietz, K; Mickler, A; Selbmann, H K

    1999-01-01

    Previous studies indicated that mortality is increased in blind subjects. However, no detailed analysis with respect to causes of blindness and the effect of additional diseases has been performed. The present study was undertaken to examine these questions. The investigation is based on social security files from the Württemberg-Hohenzollern region (population 5.5 millions) in Germany. In total, 571 files of blind subjects whose blindness benefits terminated (mostly due to death) in 1994 were included. Medical opinions on ophthalmological status and general health were extracted from the files. Standardised mortality ratios (SMRs) on the basis of life tables of former West Germany were calculated using maximum likelihood methods taking into account censoring. Most subjects in our study had one or more additional diseases at onset of blindness (74%). The SMR in all blind is 1.41 [95% CI (confidence interval) = 1.28-1.54; n= 571]. Mortality of blind subjects is increased if subjects suffer from multiple disease at onset of blindness: the SMR in blind with multiple diseases is 1.76 (95% CI = 1.58-1.94; n = 421) versus 0.85 (CI = 0.70-1.0; n = 150) in otherwise healthy blind subjects. In cases where specifically ocular diseases were responsible for the visual loss, the symbol [M] indicates that the blind subject suffered from multiple disease at onset of blindness and [E] denotes that this was not the case. The SMRs for main causes of blindness are: macular degeneration [M] 1.5 (CI = 1.3-1.8; n = 123), [E] 1.1 (CI = 0.8-1.5; n = 43); glaucoma [M] 1.6 (CI = 1.3-2.1; n = 65), [E] 1.0 (CI = 0.6-1.5; n = 26); high myopia [M] 1.2 (CI = 0.8-1.7; n = 32), [E] 0.8 (CI = 0.5-1.2; n = 21); optic atrophy [M] 1.1 (CI = 0. 6-1.8; n = 19), [E] 1.4 (CI = 0.4-3.2; n = 4), and tapetoretinal degeneration [M] 2.3 (CI = 1.1- 4.2; n = 10), [E] 0.9 (CI = 0.4-1.8; n = 12). The SMR of cases of blindness in conjunction with other diseases was fairly high for diabetic retinopathy: 5.5 (CI = 4

  9. Including health economic analysis in pilot studies: lessons learned from a cost-utility analysis within the PROSPECTIV pilot study

    Directory of Open Access Journals (Sweden)

    Richéal M. Burns

    2017-07-01

    Full Text Available PurposeTo assess feasibility and health economic benefits and costs as part of a pilot study for a nurse-led, psychoeducational intervention (NPLI for prostate cancer in order to understand the potential for cost effectiveness as well as contribute to the design of a larger scale trial.MethodsMen with stable prostate cancer post-treatment were recruited from two cancer centres in the UK. Eighty-three men were randomised to the NLPI plus usual care or usual care alone (UCA (42 NLPI and 41 UCA; the NLPI plus usual care was delivered in the primary-care setting (the intervention and included an initial face-to-face consultation with a trained nurse, with follow-up tailored to individual needs. The study afforded the opportunity to undertake a short-term within pilot analysis. The primary outcome measure for the economic evaluation was quality of life, as measured by the EuroQol five dimensions questionnaire (EQ-5D (EQ-5D-5L instrument. Costs (£2014 assessed included health-service resource use, out-of-pocket expenses and losses from inability to undertake usual activities.ResultsTotal and incremental costs varied across the different scenarios assessed, with mean cost differences ranging from £173 to £346; incremental effect, as measured by the change in utility scores over the duration of follow-up, exhibited wide confidence intervals highlighting inconclusive effectiveness (95% CI: -0.0226; 0.0438. The cost per patient of delivery of the intervention would be reduced if rolled out to a larger patient cohort.ConclusionsThe NLPI is potentially cost saving depending on the scale of delivery; however, the results presented are not considered generalisable.

  10. HERMES docking/berthing system pilot study. Quantitative assessment

    International Nuclear Information System (INIS)

    Munoz Blasco, J.; Goicoechea Sanchez, F.J.

    1993-01-01

    This study falls within the framework of the incorporation of quantitative risk assessment to the activities planned for the ESA-HERMES project (ESA/ CNES). The main objective behind the study was the analysis and evaluation of the potential contribution of so-called probabilistic or quantitative safety analysis to the optimization of the safety development process for the systems carrying out the safety functions required by the new and complex HERMES Space Vehicle. For this purpose, a pilot study was considered a good start in quantitative safety assessments (QSA), as this approach has been frequently used in the past to establish a solid base in large-scale QSA application programs while avoiding considerable economic risks. It was finally decided to select the HERMES docking/berthing system with Man Tender Free Flyer as the case-study. This report describes the different steps followed in the study, along with the main insights obtained and the general conclusions drawn from the study results. (author)

  11. Mental disorder in children with physical conditions: a pilot study.

    Science.gov (United States)

    Butler, Alexandra; Van Lieshout, Ryan J; Lipman, Ellen Louise; MacMillan, Harriet L; Gonzalez, Andrea; Gorter, Jan Willem; Georgiades, Kathy; Speechley, Kathy N; Boyle, Michael H; Ferro, Mark A

    2018-01-03

    Methodologically, to assess the feasibility of participant recruitment and retention, as well as missing data in studying mental disorder among children newly diagnosed with chronic physical conditions (ie, multimorbidity). Substantively, to examine the prevalence of multimorbidity, identify sociodemographic correlates and model the influence of multimorbidity on changes in child quality of life and parental psychosocial outcomes over a 6-month follow-up. Prospective pilot study. Two children's tertiary-care hospitals. Children aged 6-16 years diagnosed in the past 6 months with one of the following: asthma, diabetes, epilepsy, food allergy or juvenile arthritis, and their parents. Response, participation and retention rates. Child mental disorder using the Mini International Neuropsychiatric Interview at baseline and 6 months. Child quality of life, parental symptoms of stress, anxiety and depression, and family functioning. All outcomes were parent reported. Response, participation and retention rates were 90%, 83% and 88%, respectively. Of the 50 children enrolled in the study, the prevalence of multimorbidity was 58% at baseline and 42% at 6 months. No sociodemographic characteristics were associated with multimorbidity. Multimorbidity at baseline was associated with declines over 6 months in the following quality of life domains: physical well-being, β=-4.82 (-8.47, -1.17); psychological well-being, β=-4.10 (-7.62, -0.58) and school environment, β=-4.17 (-8.18, -0.16). There was no association with parental psychosocial outcomes over time. Preliminary evidence suggests that mental disorder in children with a physical condition is very common and has a negative impact on quality of life over time. Based on the strong response rate and minimal attrition, our approach to study child multimorbidity appears feasible and suggests that multimorbidity is an important concern for families. Methodological and substantive findings from this pilot study have

  12. Radiographer and radiologist perception error in reporting double contrast barium enemas: A pilot study

    International Nuclear Information System (INIS)

    Booth, Alison M.; Mannion, Richard A.J.

    2005-01-01

    Purpose: The practice of radiographers performing double contrast barium enemas (DCBE) is now widespread and in many centres the radiographer's opinion is, at least, contributing to a dual reporting system [Bewell J, Chapman AH. Radiographer performed barium enemas - results of a survey to assess progress. Radiography 1996;2:199-205; Leslie A, Virjee JP. Detection of colorectal carcinoma on double contrast barium enema when double reporting is routinely performed: an audit of current practice. Clin Radiol 2001;57:184-7; Culpan DG, Mitchell AJ, Hughes S, Nutman M, Chapman AH. Double contrast barium enema sensitivity: a comparison of studies by radiographers and radiologists. Clin Radiol 2002;57:604-7]. To ensure this change in practice does not lead to an increase in reporting errors, this study aimed to compare the perception abilities of radiographers with those of radiologists. Methods: Three gastro-intestinal (GI) radiographers and three consultant radiologists independently reported on a selection of 50 DCBE examinations, including the level of certainty in their comments for each examination. A blinded comparison of the results with an independent 'standard report' was recorded. Results: The results demonstrate there was no significant difference in perception error for any of the levels of certainty, for single reporting, for double reading by a radiographer/radiologist or by two radiologists. Conclusions: The study shows that radiographers can perceive abnormalities on DCBE at similar sensitivities and specificities as radiologists. While the participants in the study may be typical of a district general hospital, the nature of the study gives it limited external validity. As a pilot, the results demonstrate that, with slight modification, the methodology could be used for a larger study

  13. MRI study of the morphometry of the cervical musculature in F-16 pilots

    NARCIS (Netherlands)

    de Loose, Veerle; van den Oord, Marieke; Keser, Ilke; Burnotte, Frédéric; van Tiggelen, Damien; Dumarey, Alexandre; Cagnie, Barbara; Witvrouw, Erik; Danneels, Lieven

    2009-01-01

    INTRODUCTION: In fighter pilots neck muscle strengthening exercises are often recommended to protect the neck against pathologies. The aim of the current study was to compare the relative cross-sectional area (rCSA) and muscle:fat ratio of the cervical musculature of F-16 pilots experiencing neck

  14. A pilot study of workplace violence towards paramedics.

    Science.gov (United States)

    Boyle, Malcolm; Koritsas, Stella; Coles, Jan; Stanley, Janet

    2007-11-01

    International studies have shown that some 60% of paramedics have experienced physical violence in the workplace, and between 21-78% have experienced verbal abuse. To date, there is no Australian literature describing Australian paramedics' experience of workplace violence. To identify the percentage of paramedics who had experienced six different forms of workplace violence. A questionnaire was developed to explore paramedics' experience of workplace violence. Six forms of violence were included: verbal abuse, property damage or theft, intimidation, physical abuse, sexual harassment, and sexual assault. The questionnaire also included a series of demographic questions. The questionnaire was piloted using a reference group and changes made accordingly. The questionnaire was distributed to 500 rural Victorian paramedics and 430 metropolitan South Australian paramedics. Ethics approval was granted for this study. The overall response rate was 28%, with 75% being male and 25% female. The median age of respondents was 40.7 years, range 21-62 years. The median number of years experience as a paramedic was 14.3 years, range 6 months to 39 years. There were 87.5% of paramedics exposed to workplace violence. Verbal abuse was the most prevalent form of workplace violence (82%), with intimidation (55%), physical abuse (38%), sexual harassment (17%), and sexual assault (4%). This study lays the foundation for further studies investigating paramedic experience of workplace violence. This study demonstrates that workplace violence is prevalent for paramedics and highlights the need for prevention and education within the profession.

  15. First "glass" education: telementored cardiac ultrasonography using Google Glass- a pilot study.

    Science.gov (United States)

    Russell, Patrick M; Mallin, Michael; Youngquist, Scott T; Cotton, Jennifer; Aboul-Hosn, Nael; Dawson, Matt

    2014-11-01

    The objective of this study was to determine the feasibility of telementored instruction in bedside ultrasonography (US) using Google Glass. The authors sought to examine whether first-time US users could obtain adequate parasternal long axis (PSLA) views to approximate ejection fraction (EF) using Google Glass telementoring. This was a prospective, randomized, single-blinded study. Eighteen second-year medical students were randomized into three groups and tasked with obtaining PSLA cardiac imaging. Group A received real-time telementored education through Google Glass via Google Hangout from a remotely located expert. Group B received bedside education from the same expert. Group C represented the control and received no instruction. Each subject was given 3 minutes to obtain a best PSLA cardiac imaging using a portable GE Vscan. Image clips obtained by each subject were stored. A second expert, blinded to instructional mode, evaluated images for adequacy and assigned an image quality rating on a 0 to 10 scale. Group A was able to obtain adequate images six out of six times (100%) with a median image quality rating of 7.5 (interquartile range [IQR] = 6 to 10) out of 10. Group B was also able to obtain adequate views six out of six times (100%), with a median image quality rating of 8 (IQR = 7 to 9). Group C was able to obtain adequate views one out of six times (17%), with a median image quality of 0 (IQR = 0 to 2). There were no statistically significant differences between Group A and Group B in the achievement of adequate images for E-point septal separation measurement or in image quality. In this pilot/feasibility study, novice US users were able to obtain adequate imaging to determine a healthy patient's EF through telementored education using Google Glass. These preliminary data suggest telementoring as an adequate means of medical education in bedside US. This conclusion will need to be validated with larger, more powerful studies including evaluation of

  16. NONINVASIVE DIAGNOSIS OF BLADDER CANCER BY CROSS-POLARIZATION OPTICAL COHERENCE TOMOGRAPHY: A BLIND STATISTICAL STUDY

    Directory of Open Access Journals (Sweden)

    O. S. Streltsova

    2014-07-01

    Full Text Available Whether cross-polarization (CP optical coherence tomography (OCT could be used to detect early bladder cancer was ascertained; it was compared with traditional OCT within the framework of blind (closed clinical statistical studies. One hundred and sixteen patients with local nonexophytic (flat pathological processes of the bladder were examined; 360 CP OCT images were obtained and analyzed. The study used an OCT 1300-U CP optical coherence tomographer. CP OCT showed a high (94% sensitivity and a high (84% specificity in the identification of suspected nonexophytic areas in the urinary bladder.

  17. Aprotinin decreases the incidence of cognitive deficit following CABG and cardiopulmonary bypass: a pilot randomized controlled study.

    LENUS (Irish Health Repository)

    Harmon, Dominic C

    2012-02-03

    PURPOSE: Cognitive deficit after coronary artery bypass surgery (CABG) has a high prevalence and is persistent. Meta-analysis of clinical trials demonstrates a decreased incidence of stroke after CABG when aprotinin is administrated perioperatively. We hypothesized that aprotinin administration would decrease the incidence of cognitive deficit after CABG. METHODS: Thirty-six ASA III-IV patients undergoing elective CABG were included in a prospective, randomized, single-blinded pilot study. Eighteen patients received aprotinin 2 x 10(6) KIU (loading dose), 2 x 10(6) KIU (added to circuit prime) and a continuous infusion of 5 x 10(5) KIU.hr(-1). A battery of cognitive tests was administered to patients and spouses (n = 18) the day before surgery, four days and six weeks postoperatively. RESULTS: Four days postoperatively new cognitive deficit (defined by a change in one or more cognitive domains using the Reliable Change Index method) was present in ten (58%) patients in the aprotinin group compared to 17 (94%) in the placebo group [95% confidence interval (CI) 0.10-0.62, P = 0.005); (P = 0.01)]. Six weeks postoperatively, four (23%) patients in the aprotinin group had cognitive deficit compared to ten (55%) in the placebo group (95% CI 0.80-0.16, P = 0.005); (P = 0.05). CONCLUSION: In this prospective pilot study, the incidence of cognitive deficit after CABG and cardiopulmonary bypass is decreased by the administration of high-dose aprotinin.

  18. Recognition memory for Braille or spoken words: an fMRI study in early blind.

    Science.gov (United States)

    Burton, Harold; Sinclair, Robert J; Agato, Alvin

    2012-02-15

    We examined cortical activity in early blind during word recognition memory. Nine participants were blind at birth and one by 1.5years. In an event-related design, we studied blood oxygen level-dependent responses to studied ("old") compared to novel ("new") words. Presentation mode was in Braille or spoken. Responses were larger for identified "new" words read with Braille in bilateral lower and higher tier visual areas and primary somatosensory cortex. Responses to spoken "new" words were larger in bilateral primary and accessory auditory cortex. Auditory cortex was unresponsive to Braille words and occipital cortex responded to spoken words but not differentially with "old"/"new" recognition. Left dorsolateral prefrontal cortex had larger responses to "old" words only with Braille. Larger occipital cortex responses to "new" Braille words suggested verbal memory based on the mechanism of recollection. A previous report in sighted noted larger responses for "new" words studied in association with pictures that created a distinctiveness heuristic source factor which enhanced recollection during remembering. Prior behavioral studies in early blind noted an exceptional ability to recall words. Utilization of this skill by participants in the current study possibly engendered recollection that augmented remembering "old" words. A larger response when identifying "new" words possibly resulted from exhaustive recollecting the sensory properties of "old" words in modality appropriate sensory cortices. The uniqueness of a memory role for occipital cortex is in its cross-modal responses to coding tactile properties of Braille. The latter possibly reflects a "sensory echo" that aids recollection. Copyright © 2011 Elsevier B.V. All rights reserved.

  19. The effects of caffeine abstinence on sleep: a pilot study.

    Science.gov (United States)

    Ho, Shuk Ching; Chung, Joanne Wai Yee

    2013-05-01

    The aim of this study was to examine whether caffeine abstinence in the evening could improve the sleep quality of those who habitually consume coffee. A double-blind control group design (caffeine and caffeine-free groups). A university. A convenience sampling of 10 students (mean age 21.4 years). It was a 14-day experiment. For the first 7 days, all participants consumed caffeinated coffee. In the following 7 days, subjects consumed caffeinated or decaffeinated coffee according to their assigned group. Sleep-wake parameters, self-reported sleep quality and level of refreshment. There were no significant differences (p>.05) among the data of the two groups identified. No significant changes (p>.05) were found in the sleep quality of either group during the study. This study confirms that caffeine abstinence in the evening might not be helpful in sleep promotion. It highlights the need to implement evidence-based practice in health promotion. Copyright © 2013 Elsevier Inc. All rights reserved.

  20. Electroosmotically enhanced sludge dewatering-pilot-plant study

    CSIR Research Space (South Africa)

    Smollen, M

    1994-01-01

    Full Text Available role in determining the ease or difficulty of phase separation. It seems that the inefficiency of dewatering applied to gelatinous and fine-particle sludges can be overcome by mechanical dewatering enhanced by electroosmosis. A prototype pilot...

  1. Guided Imagery for Total Knee Replacement: A Randomized, Placebo-Controlled Pilot Study.

    Science.gov (United States)

    Jacobson, Ann F; Umberger, Wendy A; Palmieri, Patrick A; Alexander, Thomas S; Myerscough, Rodney P; Draucker, Claire B; Steudte-Schmiedgen, Susann; Kirschbaum, Clemens

    2016-07-01

    To determine the effect of guided imagery (GI) on functional outcomes of total knee replacement (TKR), explore psychological and neuroimmune mediators, and assess feasibility of study implementation. Investigator-blinded, randomized, placebo-controlled pilot study. Hospital, surgeon's office, participant's home. 82 persons undergoing TKR. Audiorecordings of TKR-specific GI scripts or placebo-control audiorecordings of audiobook segments. Gait velocity and Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function scale. Outcomes for 58 participants (29 receiving GI and 29 controls) were analyzed at 6 months after surgery. The most frequent reason for noncompletion was protocol-driven exclusion at 6 months for having the contralateral knee replaced before the study endpoint (n = 15). With imaging ability as a moderator, gait velocity, but not WOMAC Function score, was significantly improved at 6 months in the GI group. Participants in the GI group, but not the control group, had lower WOMAC Pain scores at 3 weeks after surgery than at baseline. Hair cortisol concentration was significantly lower at 6 months after surgery than at baseline in the GI group but not the control group. GI group participants had lower treatment adherence but greater treatment credibility than the control group. Randomized controlled trials of GI in the TKR population are feasible, but inclusion/exclusion criteria influence attrition. Further studies are needed to elaborate this study's findings, which suggest that guided imagery improves objective, but not patient-reported, outcomes of TKR. Hair cortisol concentration results suggest that engagement in a time-limited guided imagery intervention may contribute to stress reduction even after the intervention is terminated. Further investigation into optimal content and dosing of GI is needed.

  2. Cognitive rehabiliation for Parkinson's disease demantia: a study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Hindle, John V; Watermeyer, Tamlyn J; Roberts, Julie; Martyr, Anthony; Lloyd-Williams, Huw; Brand, Andrew; Gutting, Petra; Hoare, Zoe; Edwards, Rhiannon Tudor; Clare, Linda

    2016-03-22

    There is growing interest in developing non-pharmacological treatments to address the cognitive deficits apparent in Parkinson's disease dementia and dementia with Lewy bodies. Cognitive rehabilitation is a goal-oriented behavioural intervention which focuses on improving everyday functioning through management of cognitive difficulties; it has been shown to be effective in Alzheimer's disease. To date, no studies have assessed its potential efficacy for addressing the impact of cognitive impairment in people with Parkinson's disease or dementia with Lewy bodies. Participants (n = 45) will be recruited from movement disorders, care for the elderly and memory clinics. Inclusion criteria include: a diagnosis of Parkinson's disease, Parkinson's disease dementia or dementia with Lewy bodies according to consensus criteria and an Addenbrooke's Cognitive Examination - III score of ≤ 82. Exclusion criteria include: a diagnosis of any other significant neurological condition; major psychiatric disorder, including depression, which is not related to the patient's Parkinson's disease and unstable medication use for their physical or cognitive symptoms. A single-blind pilot randomised controlled trial, with concurrent economic evaluation, will compare the relative efficacy of cognitive rehabilitation with that of two control conditions. Following a goal-setting interview, the participants will be randomised to one of the three study arms: cognitive rehabilitation (eight weekly sessions), relaxation therapy (eight weekly sessions) or treatment as usual. Randomisation and treatment group allocation will be carried out by a clinical trials unit using a dynamic adaptive sequential randomisation algorithm. The primary outcomes are patients' perceived goal attainment at a 2-months post-intervention assessment and a 6-months follow-up. Secondary outcomes include patients' objective cognitive performance (on tests of memory and executive function) and satisfaction with goal

  3. Effect of transdermal magnesium cream on serum and urinary magnesium levels in humans: A pilot study.

    Science.gov (United States)

    Kass, Lindsy; Rosanoff, Andrea; Tanner, Amy; Sullivan, Keith; McAuley, William; Plesset, Michael

    2017-01-01

    Oral magnesium supplementation is commonly used to support a low magnesium diet. This investigation set out to determine whether magnesium in a cream could be absorbed transdermally in humans to improve magnesium status. In this single blind, parallel designed pilot study, n = 25 participants (aged 34.3+/-14.8y, height 171.5+/-11cm, weight 75.9 +/-14 Kg) were randomly assigned to either a 56mg/day magnesium cream or placebo cream group for two weeks. Magnesium serum and 24hour urinary excretion were measured at baseline and at 14 days intervention. Food diaries were recorded for 8 days during this period. Mg test and placebo groups' serum and urinary Mg did not differ at baseline. After the Mg2+ cream intervention there was a clinically relevant increase in serum magnesium (0.82 to 0.89 mmol/l,p = 0.29) that was not seen in the placebo group (0.77 to 0.79 mmol/L), but was only statistically significant (p = 0.02)) in a subgroup of non-athletes. Magnesium urinary excretion increased from baseline slightly in the Mg2+ group but with no statistical significance (p = 0.48). The Mg2+ group showed an 8.54% increase in serum Mg2+ and a 9.1% increase in urinary Mg2+ while these figures for the placebo group were smaller, i.e. +2.6% for serum Mg2+ and -32% for urinary Mg2+. In the placebo group, both serum and urine concentrations showed no statistically significant change after the application of the placebo cream. No previous studies have looked at transdermal absorbency of Mg2+ in human subjects. In this pilot study, transdermal delivery of 56 mg Mg/day (a low dose compared with commercial transdermal Mg2+ products available) showed a larger percentage rise in both serum and urinary markers from pre to post intervention compared with subjects using the placebo cream, but statistical significance was achieved only for serum Mg2+ in a subgroup of non-athletes. Future studies should look at higher dosage of magnesium cream for longer durations. ISRCTN registry ID No. ISRTN

  4. Effect of transdermal magnesium cream on serum and urinary magnesium levels in humans: A pilot study.

    Directory of Open Access Journals (Sweden)

    Lindsy Kass

    Full Text Available Oral magnesium supplementation is commonly used to support a low magnesium diet. This investigation set out to determine whether magnesium in a cream could be absorbed transdermally in humans to improve magnesium status.In this single blind, parallel designed pilot study, n = 25 participants (aged 34.3+/-14.8y, height 171.5+/-11cm, weight 75.9 +/-14 Kg were randomly assigned to either a 56mg/day magnesium cream or placebo cream group for two weeks. Magnesium serum and 24hour urinary excretion were measured at baseline and at 14 days intervention. Food diaries were recorded for 8 days during this period. Mg test and placebo groups' serum and urinary Mg did not differ at baseline. After the Mg2+ cream intervention there was a clinically relevant increase in serum magnesium (0.82 to 0.89 mmol/l,p = 0.29 that was not seen in the placebo group (0.77 to 0.79 mmol/L, but was only statistically significant (p = 0.02 in a subgroup of non-athletes. Magnesium urinary excretion increased from baseline slightly in the Mg2+ group but with no statistical significance (p = 0.48. The Mg2+ group showed an 8.54% increase in serum Mg2+ and a 9.1% increase in urinary Mg2+ while these figures for the placebo group were smaller, i.e. +2.6% for serum Mg2+ and -32% for urinary Mg2+. In the placebo group, both serum and urine concentrations showed no statistically significant change after the application of the placebo cream.No previous studies have looked at transdermal absorbency of Mg2+ in human subjects. In this pilot study, transdermal delivery of 56 mg Mg/day (a low dose compared with commercial transdermal Mg2+ products available showed a larger percentage rise in both serum and urinary markers from pre to post intervention compared with subjects using the placebo cream, but statistical significance was achieved only for serum Mg2+ in a subgroup of non-athletes. Future studies should look at higher dosage of magnesium cream for longer durations.ISRCTN registry ID

  5. Radon in drinking water in Co. Wicklow. A pilot study

    International Nuclear Information System (INIS)

    Ryan, T.P.; Sequeira, S.; McKittrick, L.; Colgan, P.A.

    2003-01-01

    Attention has been focused on the issue of radon in drinking water by a European Commission recommendation proposing that surveys should be undertaken in Member States to determine the scale and nature of exposures caused by radon in domestic drinking water supplies. The Commission recommends 1000 Bq/l as the radon activity concentration in private drinking water supplies above which remedial action to reduce the concentration should be taken. The logic behind the proposed action level is that it would broadly correspond to the risk posed to an individual from exposure to radon in the home at the current Reference Level of 200 Bq/m 3 in air. A pilot study to assess the distribution and concentrations of radon in private ground water supplies was recently completed in Co. Wicklow. County Wicklow was selected for the study primarily on the basis that the underlying geology is predominantly granite with elevated uranium content. Furthermore, there is an estimated 1200 to 5000 private ground water supplies in use in the county and high radon activity concentrations in air in a significant number of dwellings have previously been predicted. As part of the pilot study, a number of scientific issues were addressed in order to underpin the results obtained and these are also discussed in the report. Radon activity concentrations were measured in the private ground water supplies of 166 houses in Co. Wicklow. In all cases the ground water was the principal source of drinking water for the house occupants. Four supplies had activity concentrations in excess of the Recommended EC action level of 1000 Bq/l, fifteen had activity concentrations between 500 and 1000 Bq/l, 51 were between 100 and 500 Bq/l and 96 had activity concentrations below 100 Bq/l. The doses estimated for the ingestion of radon bearing water varies significantly with the quantity of drinking water consumed and the degree to which the water has been processed prior to consumption. However dose estimates

  6. Caffeine Awareness in Children: Insights from a Pilot Study.

    Science.gov (United States)

    Thakre, Tushar P; Deoras, Ketan; Griffin, Catherine; Vemana, Aarthi; Podmore, Petra; Krishna, Jyoti

    2015-07-15

    Caffeine, a commonly consumed psychoactive substance, can have significant effects on sleep. Caffeine intake among children is increasing, mainly in the form of sodas. However, adolescent caffeine consumers may lack knowledge about the caffeine content in common beverages. If true, this very fact may hamper the assessment of the effects of caffeine consumption on sleep in children if such assessments are a priori dependent on responders being able to reliably distinguish between caffeinated and noncaffeinated beverages. This preliminary study investigated adolescents' caffeine knowledge and intake at a Cleveland-area public middle school. Seventh- and eighth-grade students were surveyed using: (1) the Caffeine Literacy and Sleep Study (CLASS), a 15-question pilot instrument designed to assess caffeine knowledge and intake by type, quantity and timing, as well as sleep habits; and (2) the Cleveland Adolescent Sleepiness Questionnaire (CASQ), a validated survey measuring excessive daytime sleepiness in adolescents. These questionnaires were distributed and collected during a specified class period. Of the 635 seventh- and eighth-grade students who attended school on the day of the study, 555 (87%) participated. Lack of knowledge about caffeine content of particular drinks was noted in seventh and eighth graders of both sexes with nearly 29% unaware that their favorite drinks contain caffeine and more than 50% unable to correctly identify the drinks with the most caffeine. A low percentage of students correctly identified light-colored sodas lacking caffeine: 7-Up (24.1%), Sierra Mist (38.9%), ginger ale (39.8%), Sprite (39.8%), and Fresca (53.7%). The percentages of students correctly identifying caffeinated light-colored beverages were: Arizona Green Tea (43.5%), Mello Yellow (50.9%), and A&W cream soda (67.6%). However, Mountain Dew was correctly identified by most (93.5%) as caffeinated. Students were not consistently able to identify caffeine content or lack

  7. Radon in drinking water in Co. Wicklow. A pilot study

    International Nuclear Information System (INIS)

    Ryan, T.P.; Sequeira, S.; McKittrick, L.; Colgan, P.A.

    2003-02-01

    Attention has been focused on the issue of radon in drinking water by a European Commission recommendation proposing that surveys should be undertaken in Member States to determine the scale and nature of exposures caused by radon in domestic drinking water supplies. The Commission recommends 1000 Bq/l as the radon activity concentration in private drinking water supplies above which remedial action to reduce the concentration should be taken. The logic behind the proposed action level is that it would broadly correspond to the risk posed to an individual from exposure to radon in the home at the current Reference Level of 200 Bq/m3 in air. A pilot study to assess the distribution and concentrations of radon in private ground water supplies was recently completed in Co. Wicklow. County Wicklow was selected for the study primarily on the basis that the underlying geology is predominantly granite with elevated uranium content. Furthermore, there is an estimated 1200 to 5000 private ground water supplies in use in the county and high radon activity concentrations in air in a significant number of dwellings have previously been predicted. As part of the pilot study, a number of scientific issues were addressed in order to underpin the results obtained and these are also discussed in the report. Radon activity concentrations were measured in the private ground water supplies of 166 houses in Co. Wicklow. In all cases the ground water was the principal source of drinking water for the house occupants. Four supplies had activity concentrations in excess of the Recommended EC action level of 1000 Bq/l, fifteen had activity concentrations between 500 and 1000 Bq/l, 51 were between 100 and 500 Bq/l and 96 had activity concentrations below 100 Bq/l. The doses estimated for the ingestion of radon bearing water vary significantly with the quantity of drinking water consumed and the degree to which the water has been processed prior to consumption. However dose estimates based

  8. Biomagnetic Pair Therapy and Typhoid Fever: A Pilot Study.

    Science.gov (United States)

    Frank, Bryan L

    2017-10-01

    Objective: This pilot study examined the laboratory responses of patients with laboratory-documented typhoid fever who were treated with Biomagnetic Pair Therapy (BPT; medical biomagnetism), a specific application of pairs of magnets for various ailments that are infectious and otherwise. Materials and Methods: This study was an assessment of patients' response to treatment with only BPT for Salmonella typhi infections (typhoid fever) using standard conventional laboratory techniques. The research was conducted in an outpatient village clinic in Kenya. There were 52 participants who were evaluated for possible systemic illness, including typhoid fever, from an open-label study. Participants who felt sick and requested testing for possible typhoid fever were tested with a standard Widal test by a certified laboratory technician. Participants who tested positive (13 patients) were then treated with BPT (a "First Aid" approach) only. These participants then returned for follow-up laboratory and clinical evaluations after 2 days. Results: Most of the participants (10 of 13) retested as negative, and all patients reported symptomatic clinical improvement. Conclusions: As a significant majority of participants demonstrated clearing of their S. typhi after BPT, this technique should be studied further in larger trials for its efficacy in treating typhoid fever.

  9. Ambulance clinical placements – A pilot study of students' experience

    Directory of Open Access Journals (Sweden)

    Adams Bridget

    2008-04-01

    Full Text Available Abstract Background Undergraduate paramedic students undertake clinical placements in a variety of locations. These placements are considered an essential element for paramedic pre-employment education. However, anecdotal evidence suggests some students have not had positive experiences on their emergency ambulance placements. The objective of this study was to identify the type of experiences had by students during ambulance clinical placements and to provide feedback to the ambulance services. Methods In this pilot study we employed a cross-sectional study methodology, using a convenience sample of undergraduate paramedic students available in semester one of 2007 to ascertain the students' views on their reception by on-road paramedics and their overall experience on emergency ambulance clinical placements. Ethics approval was granted. Results There were 77 students who participated in the survey, 64% were females, with 92% of students Conclusion This study demonstrates that for a small group of students, emergency ambulance clinical placements were not a positive experience clinically or educationally. Some qualified paramedics doubt if a number of female students can perform the physical role of a paramedic.

  10. Homeopathy for Perennial Asthma in Adolescents: Pilot Feasibility Study Testing a Randomised Withdrawal Design.

    Science.gov (United States)

    Mitchiguian Hotta, Livia; Cardinalli Adler, Ubiratan; de Toledo Cesar, Amarilys; Martinez, Edson Zangiacomi; Demarzo, Marcelo Marcos Piva

    2018-03-26

     Previous findings from a pragmatic trial suggest that usual care compared with usual care plus individualised homeopathy is not a feasible design to address homeopathic interventions for asthma.  The main purpose of this article was to investigate the feasibility of the randomised withdrawal design as a strategy to assess the effectiveness of a standardised clinical-pharmaceutical homeopathic protocol ( Organon.modus ) on perennial asthma in adolescents.  Randomised withdrawal, double-blind, parallel, placebo-controlled, 12-week study. 12 to 17 years old adolescents, with the diagnosis of perennial asthma, using inhalatory beclomethasone (plus fenoterol for wheezing episodes), who achieved 3 months of well-controlled asthma, after a variable period of individualised homeopathic treatment according to Organon.modus protocol. a secondary care medical specialist centre. continuation with the individualised homeopathic medicine or with indistinguishable placebo during 12 weeks of beclomethasone step-down. number of days of well-controlled asthma. Secondary measures: number of days of fenoterol use, number of visits to an emergency service (without hospitalisation) and percentage of patients excluded due to an exacerbation characterising a partly controlled asthma. Tolerability was assessed by Adverse Events, registered at every visit.  Nineteen patients were randomised to continue treatment with homeopathy and 21 with placebo. Effectiveness measures for the homeopathy and placebo groups respectively were median number of days of good clinical control: 84 versus 30 ( p  = 0.18); median number of days of fenoterol use per patient: 3 versus 5 ( p  = 0.41); visits to an emergency room: 1 versus 6 ( p  = 0.35); percentage of exclusion due to partly controlled asthma: 36.8% versus 71.4% ( p  = 0.05). Few Adverse Events were reported.  This pilot study supports the feasibility of the double-blind randomised withdrawal design in studies investigating

  11. Melatonin improves sleep in children with epilepsy: randomized, double-blind cross-over study

    Science.gov (United States)

    Jain, Sejal V; Horn, Paul S; Simakajornboon, Narong; Beebe, Dean W; Holland, Katherine; Byars, Anna W; Glauser, Tracy A

    2015-01-01

    Objective Insomnia, especially maintenance insomnia is widely prevalent in epilepsy. Although melatonin is commonly used, limited data address its efficacy. We performed a randomized, double-blind, placebo-controlled, cross-over study to identify the effects of melatonin on sleep and seizure control in children with epilepsy. Methods Eleven pre-pubertal, developmentally normal children aged 6–11 years with epilepsy were randomized by software algorithm to receive placebo or 9 mg sustained release melatonin for 4 weeks, followed by a 1-week washout and 4-week crossover condition. The pharmacy performed blinding; patients, parents and study staff other than a statistician were blinded. Primary outcomes were sleep onset latency and wakefulness after sleep onset (WASO) measured on polysomnography. Secondary outcomes included seizure frequency, epileptiform spike density per hour of sleep on EEG and reaction time measures on psychomotor vigilance task. Statistical tests appropriate for cross-over designs were used for analysis. Results Data were analyzed from ten subjects who completed the study. Melatonin decreased sleep latency (Mean difference (MD): 11.4 min, p= 0.02) and WASO (MD 22 min, p=0.04) as compared to placebo. No worsening of spike density or seizure frequency was seen. Additionally, Slow-wave sleep duration and REM latency were increased with melatonin and REM sleep duration was decreased. These changes were statistically significant. Worsening of headache was noted in one subject with migraine on melatonin. Conclusion Sustained-release melatonin resulted in statistically significant decreases in sleep latency and WASO. No clear effects on seizures were observed but the study was too small to allow any conclusions to be drawn in this regard. PMID:25862116

  12. Melatonin improves sleep in children with epilepsy: a randomized, double-blind, crossover study.

    Science.gov (United States)

    Jain, Sejal V; Horn, Paul S; Simakajornboon, Narong; Beebe, Dean W; Holland, Katherine; Byars, Anna W; Glauser, Tracy A

    2015-05-01

    Insomnia, especially maintenance insomnia, is widely prevalent in epilepsy. Although melatonin is commonly used, limited data address its efficacy. We performed a randomized, double-blind, placebo-controlled, crossover study to identify the effects of melatonin on sleep and seizure control in children with epilepsy. Eleven prepubertal, developmentally normal children aged 6-11 years with epilepsy were randomized by a software algorithm to receive placebo or a 9-mg sustained release (SR) melatonin formulation for four weeks, followed by a one-week washout and a four-week crossover condition. The pharmacy performed blinding; patients, parents, and study staff other than a statistician were blinded. The primary outcomes were sleep onset latency and wakefulness after sleep onset (WASO) measured on polysomnography. The secondary outcomes included seizure frequency, epileptiform spike density per hour of sleep on electroencephalogram (EEG), and reaction time (RT) measures on psychomotor vigilance task (PVT). Statistical tests appropriate for crossover designs were used for the analysis. Data were analyzed from 10 subjects who completed the study. Melatonin decreased sleep latency (mean difference, MD, of 11.4 min and p = 0.02) and WASO (MD of 22 min and p = 0.04) as compared to placebo. No worsening of spike density or seizure frequency was seen. Additionally, slow-wave sleep duration and rapid eye movement (REM) latency were increased with melatonin and REM sleep duration was decreased. These changes were statistically significant. Worsening of headache was noted in one subject with migraine on melatonin. SR melatonin resulted in statistically significant decreases in sleep latency and WASO. No clear effects on seizures were observed, but the study was too small to allow any conclusions to be drawn in this regard. Copyright © 2015 Elsevier B.V. All rights reserved.

  13. Different formulations of botulinum toxin type A have different migration characteristics: a double-blind, randomized study.

    Science.gov (United States)

    Cliff, Sandeep H; Judodihardjo, Harryono; Eltringham, Elizabeth

    2008-03-01

    Different formulations of botulinum toxin type A (BoNTA) are not identical and may behave differently in clinical practice. The reportedly lower incidence of adverse effects with one formulation (from Allergan, Ltd.) relative to another (from Ipsen, Ltd.) may be due to differences in the degree of migration of the neurotoxin-protein complex from its injection site. A double-blind, randomized, within-subject pilot study was performed to compare the migration characteristics of each formulation. Twelve healthy volunteers were randomly assigned to receive three 0.1 mL intradermal injections in their forehead: 4 U BoNTA (Allergan) on one side, 12 U BoNTA (Ipsen) on the contralateral side, and saline in the center. At day 14, Minor's iodine starch test was performed, and the subjects walked around a hot room to induce sweating. The appearance of each forehead was documented using Canfield photography and the area of each anhidrotic halo calculated using software. Overall, the area of anhidrosis was significantly larger with BoNTA (Ipsen) than BoNTA (Allergan) - mean +/- SD of 2.7 +/- 0.78 cm(2) vs. 1.8 +/- 0.65 cm(2) (P = 0.005) - with the area of anhidrosis being greater with BoNTA (Ipsen) than BoNTA (Allergan) in 11 of the 12 subjects. Across all subjects, the area of anhidrosis was greater with BoNTA (Ipsen) than BoNTA (Allergan) by a mean of 77%. BoNTA (Ipsen) migrates more than BoNTA (Allergan) under the conditions described. The lower potential of BoNTA (Allergan) to migrate promotes more precise localization of clinical effects, thereby helping to optimize the risk/benefit ratio.

  14. Acquired brain injury self-management programme: a pilot study.

    Science.gov (United States)

    Kendrick, Denise; Silverberg, Noah D; Barlow, Susan; Miller, William C; Moffat, Jacqui

    2012-01-01

    Traditional rehabilitation is not well suited to individuals with chronic mild symptoms following an acquired brain injury. To address this, this study adapted a supported self-management programme (SMP) for this population. The aim of this study was to evaluate the potential effectiveness of this novel SMP. Retrospective case series with repeated measures. Fifty-three participants with chronic mild symptoms following an acquired brain injury (primarily mild traumatic brain injury) completed an SMP. The intervention involved eight coaching sessions with each an occupational therapist and psychologist, carried out in the community and based on SMP principles. The Canadian Occupational Performance Measure was administered at baseline, discharge and 3- and 9-month follow-up. This measure yielded scores for performance and satisfaction with daily functioning, covering the domains of self-care, productivity and leisure. A complete case analysis of programme completers revealed that participants' ratings of their occupational performance and satisfaction improved markedly between baseline and discharge from the SMP. This set of outcome measures remained stable between discharge and the two follow-up points. This pilot study suggests that SMPs may improve daily functioning in individuals with chronic mild ABI symptoms. More methodologically robust clinical trials are warranted.

  15. A pilot study on mindfulness based stress reduction for smokers

    Directory of Open Access Journals (Sweden)

    Baker Timothy B

    2007-01-01

    Full Text Available Abstract Background Mindfulness means paying attention in the present moment, non-judgmentally, without commentary or decision-making. We report results of a pilot study designed to test the feasibility of using Mindfulness Based Stress Reduction (MBSR (with minor modifications as a smoking intervention. Methods MBSR instructors provided instructions in mindfulness in eight weekly group sessions. Subjects attempted smoking cessation during week seven without pharmacotherapy. Smoking abstinence was tested six weeks after the smoking quit day with carbon monoxide breath test and 7-day smoking calendars. Questionnaires were administered to evaluate changes in stress and affective distress. Results 18 subjects enrolled in the intervention with an average smoking history of 19.9 cigarettes per day for 26.4 years. At the 6-week post-quit visit, 10 of 18 subjects (56% achieved biologically confirmed 7-day point-prevalent smoking abstinence. Compliance with meditation was positively associated with smoking abstinence and decreases in stress and affective distress. Discussions and conclusion The results of this study suggest that mindfulness training may show promise for smoking cessation and warrants additional study in a larger comparative trial.

  16. The efficacy of peloid therapy in management of hand osteoarthritis: a pilot study

    Science.gov (United States)

    Kasapoğlu Aksoy, Meliha; Altan, Lale; Eröksüz, Rıza; Metin Ökmen, Burcu

    2017-12-01

    Hand osteoarthritis (OA) is associated with pain, reduced grip strength, loss of range of motion (ROM), and joint stiffness, leading to impaired hand function and difficulty in performance of daily living activities. Mud bath therapy has been reported to play a primary role in the prevention and management of OA. Thus, we planned to conduct a study aimed at investigating the effects of peloid therapy on pain, functional state, grip strength, and the quality of life and performing a comparative analysis of the outcomes of peloid therapy. In this randomized, controlled, single-blind, pilot study, patients ( n = 33) underwent peloid therapy over 2 weeks, 5 sessions a week, for a total of 10 sessions and home exercise program in group 1. Patients in group 2 (control, n = 30) received only the same home exercise program as in group 1. Patients were evaluated just before, and 2 and 6 weeks after the start of the study with Visual Analogue Scale (VAS), Australian/Canadian Hand Osteoarthritis Index (AUSCAN), Health Assessment Questionnaire (HAQ), hand grip strength (HGS), and pinch strength (PS). Statistically significant improvements were observed in all parameters assessed at week 2 and week 6 in the group 1 ( p < 0.05). Statistically significant differences were observed in HGS scores in the group 2 at week 2 and in AUSCAN scores at week 6 ( p < 0.05). Intergroup comparisons of the scores revealed significant differences between the peloid therapy group and control group in VAS, HAQ, AUSCAN, HGS, and PS scores at week 2 and week 6 ( p < 0.05). This study demonstrates that peloid therapy might be an effective and confident treatment modality in the management of symptomatic osteoarthritis of the hand and may provide effective pain control and improvements in the hand functions, quality of life, and grip strength.

  17. Caffeine supplementation improves countermovement jump in youth soccer players: a pilot study

    Directory of Open Access Journals (Sweden)

    Juan Diego Hernández-Camacho

    2017-07-01

    Full Text Available Introduction: The objective of this study was to analyze the effect of caffeine ingestion in soccer performance, particularly in the countermovement jump test (CMJ. Material and methods: A total of 17 players from a U-19 amateur Spanish team participated in this pilot study. A double-blind placebo-controlled randomized experimental design was used in 2 different sessions (1.5 hour per session separated by 1 week. CMJ was collected at the beginning and at the end of sessions; Rating of Perceived Exertion (RPE was recorded. Players ingested caffeine or placebo at the beginning of session (minute 0 of session, providing a total of 4 mg of caffeine or a placebo per kg of body mass. Side effects from caffeine and placebo ingestions were analyzed. The effect sizes (ES were calculated using values for Cohen’s and Quantitative differences were assessed qualitatively (QA. Results: The jump height with caffeine supplementation at the beginning of training was 37.03 (±3.87 cm and at the end was 39.35 (±4.05 cm, obtaining significant improvements (p<0.05; ES: 0.56; QA: 99/1/0. Significant differences on CMJ at the end of the training session between caffeine and placebo groups were observed (39.35 [±4.05] cm vs. 36.85 [±3.15] cm; p<0.05; ES: 0.65; QA: 0/1/99. Significant differences on RPE between groups were observed. A non-significant tendency to suffer more side effects with caffeine ingestion was obtained. Conclusions: This study shows how the ingestion of 4 mg of caffeine per kg of body mass could be an ergogenic aid to improve soccer performance. However, further studies with bigger soccer players sample would be necessary to refute the present results.

  18. A new in situ model to study erosive enamel wear, a clinical pilot study.

    NARCIS (Netherlands)

    Ruben, J.L.; Truin, G.J.; Bronkhorst, E.M.; Huysmans, M.C.D.N.J.M.

    2017-01-01

    OBJECTIVES: To develop an in situ model for erosive wear research which allows for more clinically relevant exposure parameters than other in situ models and to show tooth site-specific erosive wear effect of an acid challenge of orange juice on enamel. METHODS: This pilot study included 6

  19. Efficacy of blue light vs. red light in the treatment of psoriasis: a double-blind, randomized comparative study.

    NARCIS (Netherlands)

    Kleinpenning, M.M.; Otero, M.E.; Erp, P.E.J. van; Gerritsen, M.J.P.; Kerkhof, P.C.M. van de

    2012-01-01

    BACKGROUND: Protoporphyrin IX is present in psoriatic skin without the preceding application of aminolevulinic acid. Therefore, endogenous photosensitizers in psoriasis are a potential target for photodynamic treatment with high-dose visible light. OBJECTIVES: In the present pilot study, treatment

  20. A double-blind study of SB-220453 (Tonerbasat) in the glyceryltrinitrate (GTN) model of migraine

    DEFF Research Database (Denmark)

    Tvedskov, Jesper Filtenborg; Iversen, H K; Olesen, J

    2004-01-01

    inflammation, blocks propagation of spreading depression and inhibits trigeminal nerve ganglion stimulation-induced carotid vasodilatation. We included 15 patients with migraine without aura in a randomized double-blind crossover study. SB-220453 40 mg or placebo was followed by a 20-min GTN infusion. Headache.......1 alone (4 vs. 5). SB-220453 had no significant pre-emptive anti-migraine activity compared with placebo in this human model of migraine. Interaction between SB-220453 and GTN was discovered. This is important for the future development of the compound and underlines the usefulness of experimental...

  1. "Live high-train low" using normobaric hypoxia: a double-blinded, placebo-controlled study

    DEFF Research Database (Denmark)

    Siebenmann, Christoph; Robach, Paul; Jacobs, Robert A

    2012-01-01

    The combination of living at altitude and training near sea level [live high-train low (LHTL)] may improve performance of endurance athletes. However, to date, no study can rule out a potential placebo effect as at least part of the explanation, especially for performance measures. With the use...... of a placebo-controlled, double-blinded design, we tested the hypothesis that LHTL-related improvements in endurance performance are mediated through physiological mechanisms and not through a placebo effect. Sixteen endurance cyclists trained for 8 wk at low altitude (...

  2. The antimyotonic effect of lamotrigine in non-dystrophic myotonias: a double-blind randomized study

    DEFF Research Database (Denmark)

    Andersen, Grete; Hedermann, Gitte; Witting, Nanna

    2017-01-01

    , and randomized patients in blocks of 10. Participants and investigators were all blinded to treatment until the end of the trial. In two 8-week periods, oral lamotrigine or placebo capsules were provided once daily, with increasing doses (from 25 mg, 50 mg, 150 mg to 300 mg) every second week. The primary...... was registered at ClinicalTrials.gov (NCT02159963) and EudraCT (2013-003309-24). We included 26 patients (10 females, 16 males, age: 19-74 years) from 13 November 2013 to 6 July 2015. Twenty-two completed the entire study. One patient withdrew due to an allergic reaction to lamotrigine. Three patients withdrew...

  3. Treatment diary for botulinum toxin spasticity treatment: a pilot study

    Science.gov (United States)

    Iversen, Helle K.; Frederiksen, Inge M.S.; Vilhelmsen, Jeanet R.; Biering-Sørensen, Fin

    2017-01-01

    The aim of this study is to develop a treatment diary for patients receiving spasticity treatment including botulinum toxin injection and physiotherapy and/or occupational therapy. The diary focuses on problems triggered by skeletal muscle overactivity; agreed goals for treatment and the patient’s self-evaluation of achievement on the Goal Attainment Scale; which skeletal muscles were injected; physiotherapists’ and occupational therapists’ evaluation of the patients’ achievement of objectives on the Goal Attainment Scale; and proposals for optimization of treatment and changing goals. The evaluation included a satisfaction questionnaire and the WHO-QoL BREF and WHO-5 well-being score. Overall, 10 patients were enrolled in the pilot study. The patients were generally satisfied with the diary, found that it involved them more in their treatment and made it easier to set personal goals, and found it worth the time spent using it. However, no clear advantage in relation to their quality of life (WHO-QoL BREF and WHO-5 well-being score) was reported. PMID:28225535

  4. Lower limb direct skeletal attachment. A Yucatan micropig pilot study.

    Science.gov (United States)

    Saunders, Marnie M; Brecht, J Stephen; Verstraete, Mary C; Kay, David B; Njus, Glen O

    2012-12-01

    Regardless of the type of prosthetic lower limb, successful ambulation requires proper prosthetic attachment. To help alleviate many of the problems associated with prosthetic attachment, direct skeletal attachment (DSA) has been proposed as an alternative to conventional sockets. The purpose of the current study was to evaluate the feasibility of lower limb DSA in a micropig model and to develop a systematic approach to the development and analysis of DSA systems. The DSA device consisted of two stages. The load-carrying stage embedded in the bone canal was designed using bone remodeling theory in conjunction with finite element analysis to approximate implant-induced remodeling and stabilization out to 36 months postimplantation. The skin-interfacing stage was designed to maintain an immutable infection barrier where the prosthesis exited the body. Following successful design, fabrication, and benchtop evaluation, the device was surgically implanted in a Yucatan micropig. The animal trial was successful out to 10 weeks and revealed potential flaws in the surgical protocol related to thermal necrosis. However, no signs of infection were present at the time of implant retrieval. While results of this pilot study support the feasibility of a DSA approach to prosthetic limb attachment, additional animal trials are necessary to prove long-term viability.

  5. Patterns of Sweet Taste Liking: A Pilot Study

    Directory of Open Access Journals (Sweden)

    Keiko Asao

    2015-08-01

    Full Text Available Two distinct patterns of sweet taste liking have been described: one showing a peak liking response in the mid-range of sucrose concentrations and the other showing a monotonic liking response at progressively higher sucrose concentrations. Classification of these patterns has been somewhat arbitrary. In this report, we analyzed patterns of sweet taste liking in a pilot study with 26 adults including 14 women and 12 men, 32.6 ± 14.5 years of age with body mass index 26.4 ± 5.1 kg/m2 (mean ± SD. Sweet taste liking was measured for 10 levels of sucrose solutions (0.035 M to 1.346 M. Participants rated their liking of each solution using a visual analog scale with 0 indicating strongly disliking and 100 strongly liking. The cluster analysis demonstrated two distinct groups: 13 liked relatively low sucrose concentrations and liked high sucrose concentrations less, and 13 liked high sucrose concentrations greatly. If we use the 0.598 M sucrose solution alone and a cutoff liking score of 50, we can distinguish the two clusters with high sensitivity (100% and specificity (100%. If validated in additional studies, this simple tool may help us to better understand eating behaviors and the impact of sweet taste liking on nutrition-related disorders.

  6. Enhancing treatment effectiveness through social modelling: A pilot study.

    Science.gov (United States)

    Faasse, Kate; Perera, Anna; Loveys, Kate; Grey, Andrew; Petrie, Keith J

    2017-05-01

    Medical treatments take place in social contexts; however, little research has investigated how social modelling might influence treatment outcomes. This experimental pilot study investigated social modelling of treatment effectiveness and placebo treatment outcomes. Fifty-nine participants took part in the study, ostensibly examining the use of beta-blockers (actually placebos) for examination anxiety. Participants were randomly assigned to observe a female confederate report positive treatment effects (reduced heart rate, relaxed, calm) or feeling no different. Heart rate, anxiety and blood pressure were assessed, as were symptoms and attributed side effects. Heart rate decreased significantly more in the social modelling compared to control condition, p = .027 (d = .63), and there were trends towards effects in the same direction for both anxiety, p = .097 (d = .46), and systolic blood pressure, p = .077 (d = .51). Significant pre-post placebo differences in heart rate, anxiety and diastolic blood pressure were found in the social modelling group, ps  .28 (ds = .09-.59). Social observation of medication effectiveness enhanced placebo effectiveness in heart rate, and showed a trend towards enhancing treatment effectiveness in both anxiety and systolic blood pressure. Social modelling may have utility in enhancing the effectiveness of many active medical treatments.

  7. Observing position and movements in hydrotherapy: a pilot study.

    Science.gov (United States)

    Stark, Mary Ann; Rudell, Barb; Haus, George

    2008-01-01

    To observe and describe the positions and movements women choose while immersed in water during the first stage of labor. Descriptive, observational pilot study. A rural community hospital that provided hydrotherapy in labor. Women (N = 7) who intended to use hydrotherapy in labor were recruited prenatally from a midwife-managed practice. For 15 minutes of each hour during the first stage of labor, position and movements of the participants were observed and recorded on a laptop computer. The observational tool was developed for this study from a review of the literature and interviews with nursing experts; 435 observations were recorded. Women were free to choose when and how long to use hydrotherapy and had no restriction on their positions and movements. Only 3 of the 7 participants labored in the tub. Women demonstrated a greater range of positions and movements in the tub than in bed, both throughout labor and during late first-stage labor (7-10 cm of dilatation). Women had more contractions and made more rhythmic movements while in the tub than in bed. Hydrotherapy may encourage upright positions and movements that facilitate labor progress and coping, helping women avoid unnecessary interventions.

  8. Teriparatide for Idiopathic Osteoporosis in Premenopausal Women: A Pilot Study

    Science.gov (United States)

    Cohen, Adi; Stein, Emily M.; Recker, Robert. R.; Lappe, Joan M.; Dempster, David W.; Zhou, Hua; Cremers, Serge; McMahon, Donald J.; Nickolas, Thomas L.; Müller, Ralph; Zwahlen, Alexander; Young, Polly; Stubby, Julie

    2013-01-01

    Context: Premenopausal women with idiopathic osteoporosis (IOP) have abnormal cortical and trabecular bone microarchitecture. Objective: The purpose of this study was to test the hypotheses that teriparatide increases bone mineral density (BMD) and bone formation and improves trabecular microarchitecture and stiffness in women with IOP. Design: This was an open-label pilot study. Setting: The setting was a tertiary care referral center. Patients: Participants were 21 premenopausal women with unexplained fragility fractures or low BMD. Intervention: Teriparatide was administered at 20 μg daily for 18 to 24 months. Main Outcome Measures: The primary endpoint was within-subject percent change in lumbar spine BMD. Secondary endpoints included percent change in hip and forearm BMD, transiliac biopsy parameters (trabecular bone volume, microarchitecture, stiffness, and adipocytes), serum N-terminal propeptide of procollagen type 1 (P1NP), and C-telopeptide. Results: BMD increased at the spine (10.8 ± 8.3% [SD]), total hip (6.2 ± 5.6%), and femoral neck (7.6 ± 3.4%) (all P Teriparatide was associated with increased spine and hip BMD and improved trabecular microarchitecture and stiffness at the iliac crest in the majority of women with IOP. PMID:23543660

  9. Patterns of federal Internet offenders: a pilot study.

    Science.gov (United States)

    Burgess, Ann W; Carretta, Carrie M; Burgess, Allen G

    2012-09-01

    Internet-facilitated sexual offending is receiving increased forensic and clinical attention. Two issues confront this field. First, studies are equivocal as to whether (or not) the possession of Internet pornography can escalate to contact sexual offenses against a child, and second, federal judges have been questioning the length of sentences for users only of child pornography. The findings of this pilot study of 101 federal Internet offenders revealed over half of the men at the time of arrest were employed, educated, were in (or had been in) a relationship, had children, and did not have a prior criminal offense, suggesting a changing profile of a convicted sex offender. Forensic and psychiatric nurses who evaluate users of child pornography contraband need to be knowledgeable of Internet file transfer technology and the various types of contraband viewed specifically for the age of the preferred child, extreme acts to the child (e.g., bondage, S&M), and whether the user prefers images of adults with children or images of children only. © 2012 International Association of Forensic Nurses.

  10. Leading teams during simulated pediatric emergencies: a pilot study.

    Science.gov (United States)

    Coolen, Ester H; Draaisma, Jos M; den Hamer, Sabien; Loeffen, Jan L

    2015-01-01

    Leadership has been identified as a key variable for the functioning of teams and as one of the main reasons for success or failure of team-based work systems. Pediatricians often function as team leaders in the resuscitation of a critically ill child. However, pediatric residents often report having little opportunity to perform in the role of team leader during residency. In order to gain more insight into leadership skills and behaviors, we classified leadership styles of pediatric residents during simulated emergencies. We conducted a prospective quantitative study to investigate leadership styles used by pediatric residents during simulated emergencies with clinical deterioration of a child at a pediatric ward. Using videotaped scenarios of 48 simulated critical events among 12 residents, we were able to classify verbal and nonverbal communication into different leadership styles according to the situational leadership theory. The coaching style (mean 54.5%, SD 7.8) is the most frequently applied by residents, followed by the directing style (mean 35.6%, SD 4.1). This pattern conforms to the task- and role-related requirements in our scenarios and it also conforms to the concept of situational leadership. We did not find any significant differences in leadership style according to the postgraduate year or scenario content. The model used in this pilot study helps us to gain a better understanding of the development of effective leadership behavior and supports the applicability of situational leadership theory in training leadership skills during residency.

  11. Daily personal exposure to black carbon: A pilot study

    Science.gov (United States)

    Williams, Ryan D.; Knibbs, Luke D.

    2016-05-01

    Continuous personal monitoring is the benchmark for air pollution exposure assessment. Black carbon (BC) is a strong marker of primary combustion like vehicle and biomass emissions. There have been few studies that quantified daily personal BC exposure and the contribution that different microenvironments make to it. In this pilot study, we used a portable aethalometer to measure BC concentrations in an individual's breathing zone at 30-s intervals while he performed his usual daily activities. We used a GPS and time-activity diary to track where he spent his time. We performed twenty 24-h measurements, and observed an arithmetic mean daily exposure concentration of 603 ng/m3. We estimated that changing commute modes from bus to train reduced the 24-h mean BC exposure concentration by 29%. Switching from open windows to closed windows and recirculated air in a car led to a reduction of 32%. Living in a home without a wood-fired heater caused a reduction of 50% compared with a wood-heated home. Our preliminary findings highlight the potential utility of simple approaches to reduce a person's daily BC exposure.

  12. Interproximal periodontal defect model in dogs: a pilot study.

    Science.gov (United States)

    Jung, U-W; Chang, Y-Y; Um, Y-J; Kim, C-S; Cho, K-S; Choi, S-H

    2011-01-01

    This study aimed to evaluate the validity of a surgically created interproximal periodontal defect in dogs. Surgery was performed in the interproximal area between the maxillary second and third premolars in two beagle dogs. Following an incision and reflection of the gingival flap, a 3-mm wide and 5-mm high defect was prepared surgically at the interproximal area. A thorough root planing was performed and the flap was coronally positioned and sutured. The contra-lateral area was served as the control with no surgical intervention. After 8 weeks of healing, the animals were killed and the defect was analysed histometrically and radiographically. The interproximal periodontal defect resembled a naturally occurring defect and mimicked a clinical situation. After healing, the defect showed limited bone (0.89±0.02mm) and cementum regeneration (1.50± 0.48mm). Within the limitations of this pilot study, the interproximal periodontal defect showed limited bone and cementum regeneration. Thus, it can be considered as a standardized, reproducible defect model for testing new biomaterials. © 2010 John Wiley & Sons A/S.

  13. [Telerehabilitation to treat stress urinary incontinence. Pilot study].

    Science.gov (United States)

    Carrión Pérez, Francisca; Rodríguez Moreno, María Sofía; Carnerero Córdoba, Lidia; Romero Garrido, Marina C; Quintana Tirado, Laura; García Montes, Inmaculada

    2015-05-21

    We aimed to test a new telerehabilitation device for stress urinary incontinence (SUI) in order to make an initial assessment of its effectiveness. Randomized, controlled pilot study. experimental group (10 patients): pelvic floor muscle training, device training and home treatment with it; control group (9 patients): conventional rehabilitation treatment. Outcome measures (baseline and 3 months) overall and specific quality of life: International Consultation Incontinence Questionnaire and King's Health Questionnaire, bladder diary, perineometry, satisfaction with the program and degree of compliance. Baseline characteristics were similar in both groups. There was no statistically significant difference for any outcome measures between groups at the end of the follow-up. The change in perineometry values at baseline and after the intervention was significant in the experimental group (23.06 to 32.00, P=.011). No group in this study had any serious adverse effects. The tested device is safe and well accepted. Although there is some evidence of its efficacy in the rehabilitation treatment of SUI, larger trials are needed to appropriately evaluate the potential advantages. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

  14. A pilot study of bendamustine in advanced bile duct cancer.

    Science.gov (United States)

    Schoppmeyer, Konrad; Kreth, Florian; Wiedmann, Marcus; Mössner, Joachim; Preiss, Rainer; Caca, Karel

    2007-07-01

    We performed a pilot study to evaluate the safety and tolerability of bendamustine in patients with advanced hilar bile duct cancer and impaired liver function. Six patients with histologically proven, unresectable adenocarcinoma of the hilar bile duct were treated with bendamustine 140 mg/m intravenously on day 1 of the first cycle and with bendamustine 100 mg/m on days 1 and 2 of the second to fourth cycle. Treatment cycles were repeated every 21 days. Primary endpoint was the safety and tolerability of the treatment; secondary endpoints were response rate, time to progression and overall survival. Transient lymphopenia grade 3 occurred in all six patients. No other grade 3 or 4 toxicities were present. The most common nonhematologic toxicity was mouth dryness grade 2 in six patients. Three patients had stable disease. No partial or complete responses were observed. Median time to progression was 3.3 months; median overall survival was 6 months. Our study demonstrates that bendamustine can be safely administered in patients with hilar bile duct cancer and impaired liver function. A potential role of bendamustine in combination therapies for bile duct cancer will be a subject of further trials.

  15. Leading teams during simulated pediatric emergencies: a pilot study

    Science.gov (United States)

    Coolen, Ester H; Draaisma, Jos M; den Hamer, Sabien; Loeffen, Jan L

    2015-01-01

    Purpose Leadership has been identified as a key variable for the functioning of teams and as one of the main reasons for success or failure of team-based work systems. Pediatricians often function as team leaders in the resuscitation of a critically ill child. However, pediatric residents often report having little opportunity to perform in the role of team leader during residency. In order to gain more insight into leadership skills and behaviors, we classified leadership styles of pediatric residents during simulated emergencies. Methods We conducted a prospective quantitative study to investigate leadership styles used by pediatric residents during simulated emergencies with clinical deterioration of a child at a pediatric ward. Using videotaped scenarios of 48 simulated critical events among 12 residents, we were able to classify verbal and nonverbal communication into different leadership styles according to the situational leadership theory. Results The coaching style (mean 54.5%, SD 7.8) is the most frequently applied by residents, followed by the directing style (mean 35.6%, SD 4.1). This pattern conforms to the task- and role-related requirements in our scenarios and it also conforms to the concept of situational leadership. We did not find any significant differences in leadership style according to the postgraduate year or scenario content. Conclusion The model used in this pilot study helps us to gain a better understanding of the development of effective leadership behavior and supports the applicability of situational leadership theory in training leadership skills during residency. PMID:25610010

  16. Results of the 'in control: no alcohol!' pilot study.

    Science.gov (United States)

    Mares, Suzanne H W; van der Vorst, Haske; Vermeulen-Smit, Evelien; Lichtwarck-Aschoff, Anna; Verdurmen, Jacqueline E E; Engels, Rutger C M E

    2012-04-01

    More than 50% of Dutch 12-year olds already started drinking. Since it is known that delaying the onset of alcohol use results in a lower risk of alcohol-related problems, the recently developed 'In control: No alcohol!' prevention program is targeted at elementary school children and their mothers. In this pilot study, the success of program implementation and impact of the program on quality of alcohol-specific communication, rules and monitoring were evaluated, using a randomized controlled design. A total of 108 children (11-12 years) and their mothers participated in the prevention program, while the control group consisted of 105 dyads. Families participating in the experimental condition showed an increase in frequency of alcohol-specific communication and 75% of the dyads reported that they took part in at least 3 of 5 magazines, suggesting implementation was successful. The program led to an increase in quality of communication but only for those dyads in which mothers' alcohol use was above average. The program led parents to set up a non-drinking contract with their children and to monitor their children more closely. Results are promising but need to be replicated in a larger longitudinal study.

  17. Pilot multimodal twin imaging study of generalized anxiety disorder.

    Science.gov (United States)

    Hettema, John M; Kettenmann, Birgit; Ahluwalia, Vishwadeep; McCarthy, Christopher; Kates, Wendy R; Schmitt, James E; Silberg, Judy L; Neale, Michael C; Kendler, Kenneth S; Fatouros, Panos

    2012-03-01

    Generalized anxiety disorder (GAD) is a common chronic condition that is relatively understudied compared to other psychiatric syndromes. Neuroimaging studies have begun to implicate particular neural structures and circuitry in its pathophysiology; however, no genetically informative research has examined the potential sources of reported brain differences. We acquired spectroscopic, volumetric, and diffusion tensor magnetic resonance imaging data from a pilot study of 34 female subjects selected from monozygotic twin pairs based upon their affection status for GAD, and examined brain regions previously implicated in fear and anxiety for their relationship with affection status and genetic risk. Lifetime GAD associated with increased creatine levels in the amygdala, smaller left hippocampal volume, and lower fractional anisotropy in the uncinate fasciculus which connects amygdala and frontal cortex. In addition, GAD genetic risk predicted increases in myo-inositol in the amygdala and, possibly, glutamate/glutamine/GABA alterations in the hippocampus. The association of lifetime GAD with smaller hippocampal volume was independent of major depression and might represent a common genetic risk marker for internalizing disorders. These preliminary data suggest that GAD and its genetic risk factors are likely correlated with volumetric and spectroscopic changes in fear-related limbic structures and their connections with the frontal cortex. © 2011 Wiley-Liss, Inc.

  18. Esophageal-guided biopsy with volumetric laser endomicroscopy and laser cautery marking: a pilot clinical study.

    Science.gov (United States)

    Suter, Melissa J; Gora, Michalina J; Lauwers, Gregory Y; Arnason, Thomas; Sauk, Jenny; Gallagher, Kevin A; Kava, Lauren; Tan, Khay M; Soomro, Amna R; Gallagher, Timothy P; Gardecki, Joseph A; Bouma, Brett E; Rosenberg, Mireille; Nishioka, Norman S; Tearney, Guillermo J

    2014-06-01

    Biopsy surveillance protocols for the assessment of Barrett's esophagus can be subject to sampling errors, resulting in diagnostic uncertainty. Optical coherence tomography is a cross-sectional imaging technique that can be used to conduct volumetric laser endomicroscopy (VLE) of the entire distal esophagus. We have developed a biopsy guidance platform that places endoscopically visible marks at VLE-determined biopsy sites. The objective of this study was to demonstrate in human participants the safety and feasibility of VLE-guided biopsy in vivo. A pilot feasibility study. Massachusetts General Hospital. A total of 22 participants were enrolled from January 2011 to June 2012 with a prior diagnosis of Barrett's esophagus. Twelve participants were used to optimize the laser marking parameters and the system platform. A total of 30 target sites were selected and marked in real-time by using the VLE-guided biopsy platform in the remaining 10 participants. Volumetric laser endomicroscopy. Endoscopic and VLE visibility, and accuracy of VLE diagnosis of the tissue between the laser cautery marks. There were no adverse events of VLE and laser marking. The optimal laser marking parameters were determined to be 2 seconds at 410 mW, with a mark separation of 6 mm. All marks made with these parameters were visible on endoscopy and VLE. The accuracies for diagnosing tissue in between the laser cautery marks by independent blinded readers for endoscopy were 67% (95% confidence interval [CI], 47%-83%), for VLE intent-to-biopsy images 93% (95% CI, 78%-99%), and for corrected VLE post-marking images 100% when compared with histopathology interpretations. This is a single-center feasibility study with a limited number of patients. Our results demonstrate that VLE-guided biopsy of the esophagus is safe and can be used to guide biopsy site selection based on the acquired volumetric optical coherence tomography imaging data. ( NCT01439633.). Copyright © 2014 American Society for

  19. A Pilot Study Assessing ECG versus ECHO Ventriculoventricular Optimization in Pediatric Resynchronization Patients.

    Science.gov (United States)

    Punn, Rajesh; Hanisch, Debra; Motonaga, Kara S; Rosenthal, David N; Ceresnak, Scott R; Dubin, Anne M

    2016-02-01

    Cardiac resynchronization therapy indications and management are well described in adults. Echocardiography (ECHO) has been used to optimize mechanical synchrony in these patients; however, there are issues with reproducibility and time intensity. Pediatric patients add challenges, with diverse substrates and limited capacity for cooperation. Electrocardiographic (ECG) methods to assess electrical synchrony are expeditious but have not been extensively studied in children. We sought to compare ECHO and ECG CRT optimization in children. Prospective, pediatric, single-center cross-over trial comparing ECHO and ECG optimization with CRT. Patients were assigned to undergo either ECHO or ECG optimization, followed for 6 months, and crossed-over to the other assignment for another 6 months. ECHO pulsed-wave tissue Doppler and 12-lead ECG were obtained for 5 VV delays. ECG optimization was defined as the shortest QRSD and ECHO optimization as the lowest dyssynchrony index. ECHOs/ECGs were interpreted by readers blinded to optimization technique. After each 6 month period, these data were collected: ejection fraction, velocimetry-derived cardiac index, quality of life, ECHO-derived stroke distance, M-mode dyssynchrony, study cost, and time. Outcomes for each optimization method were compared. From June 2012 to December 2013, 19 patients enrolled. Mean age was 9.1 ± 4.3 years; 14 (74%) had structural heart disease. The mean time for optimization was shorter using ECG than ECHO (9 ± 1 min vs. 68 ± 13 min, P ECG. No other outcome differed between groups. ECHO optimization of synchrony was not superior to ECG optimization in this pilot study. ECG optimization required less time and cost than ECHO optimization. © 2015 Wiley Periodicals, Inc.

  20. Reducing the radiation dose for CT colonography using adaptive statistical iterative reconstruction: A pilot study.

    Science.gov (United States)

    Flicek, Kristina T; Hara, Amy K; Silva, Alvin C; Wu, Qing; Peter, Mary B; Johnson, C Daniel

    2010-07-01

    The purpose of our study was to evaluate the feasibility of preserving image quality during CT colonography (CTC) using a reduced radiation dose with adaptive statistical iterative reconstruction (ASIR). A proven colon phantom was imaged at standard dose settings (50 mAs) and at reduced doses (10-40 mAs) using six different ASIR levels (0-100%). We assessed 2D and 3D image quality and noise to determine the optimal dose and ASIR setting. Eighteen patients were then scanned with a standard CTC dose (50 mAs) in the supine position and at a reduced dose of 25 mAs with 40% ASIR in the prone position. Three radiologists blinded to the scanning techniques assessed 2D and 3D image quality and noise at three different colon locations. A score difference of > or = 1 was considered clinically important. Actual noise measures were compared between the standard-dose and low-dose acquisitions. The phantom study showed image noise reduction that correlated with a higher percentage of ASIR. In patients, no significant image quality differences were identified between standard- and low-dose images using 40% ASIR. Overall image quality was reduced for both image sets as body mass index increased. Measured image noise was less with the low-dose technique using ASIR. The results of this pilot study show that the radiation dose during CTC can be reduced 50% below currently accepted low-dose techniques without significantly affecting image quality when ASIR is used. Further evaluation in a larger patient group is warranted.

  1. Fractional Carbon Dioxide Laser for Keratosis Pilaris: A Single-Blind, Randomized, Comparative Study

    Directory of Open Access Journals (Sweden)

    Vasanop Vachiramon

    2016-01-01

    Full Text Available Objective. Keratosis pilaris (KP is a common condition which can frequently be cosmetically disturbing. Topical treatments can be used with limited efficacy. The objective of this study is to evaluate the effectiveness and safety of fractional carbon dioxide (CO2 laser for the treatment of KP. Patients and Methods. A prospective, randomized, single-blinded, intraindividual comparative study was conducted on adult patients with KP. A single session of fractional CO2 laser was performed to one side of arm whereas the contralateral side served as control. Patients were scheduled for follow-up at 4 and 12 weeks after treatment. Clinical improvement was graded subjectively by blinded dermatologists. Patients rated treatment satisfaction at the end of the study. Results. Twenty patients completed the study. All patients stated that the laser treatment improved KP lesions. At 12-week follow-up, 30% of lesions on the laser-treated side had moderate to good improvement according to physicians’ global assessment (p=0.02. Keratotic papules and hyperpigmentation appeared to respond better than the erythematous component. Four patients with Fitzpatrick skin type V developed transient pigmentary alteration. Conclusions. Fractional CO2 laser treatment may be offered to patients with KP. Dark-skinned patients should be treated with special caution.

  2. 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.

  3. Lung cancer correlates in Lebanese adults: A pilot case–control study

    Directory of Open Access Journals (Sweden)

    Joseph Aoun

    2013-12-01

    Conclusion: In this pilot study, it was found that in addition to smoking, outdoor and indoor pollution factors were potential risk factors of lung cancer. Additional studies would be necessary to confirm these findings.

  4. Arctic Ice Dynamics Joint Experiment (AIDJEX) Second Pilot Study, March - May 1972: A Documentary Film

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The project described in this documentary was a pilot study conducted in 1972 in preparation for the AIDJEX main experiment of 1975 to 1976. The study included a...

  5. Pilot case-control study of paediatric falls from windows.

    Science.gov (United States)

    Johnston, Brian D; Quistberg, D Alexander; Shandro, Jamie R; Partridge, Rebecca L; Song, Hyun Rae; Ebel, Beth E

    2011-12-01

    Unintentional falls from windows are an important cause of paediatric morbidity. There have been no controlled studies to identify modifiable environmental risk factors for window falls in young children. The authors have piloted a case-control study to test procedures for case identification, subject enrolment, and environmental data collection. Case windows were identified when a child 0-9 years old presented for care after a fall from that window. Control windows were identified (1) from the child's home and (2) from the home of an age- and gender-matched child seeking care for an injury diagnosis not related to a window fall. Study staff visited enrolled homes to collect window measurements and conduct window screen performance tests. The authors enrolled and collected data on 18 case windows, 18 in-home controls, and 14 matched community controls. Six potential community controls were contacted for every one enrolled. Families who completed the home visit viewed study procedures positively. Case windows were more likely than community controls to be horizontal sliders (100% vs 50%), to have deeper sills (6.28 vs 4.31 inches), to be higher above the exterior surface (183 vs 82 inches), and to have screens that failed below a threshold derived from the static pressure of a 3-year-old leaning against the mesh (60.0% vs 16.7%). Case windows varied very little from in-home controls. Case-control methodology can be used to study risk factors for paediatric falls from windows. Recruitment of community controls is challenging but essential, because in-home controls tend to be over-matched on important variables. A home visit allows direct measurement of window type, height, sill depth, and screen performance. These variables should all be investigated in subsequent, larger studies covering major housing markets.

  6. Blind Astronomers

    Science.gov (United States)

    Hockey, Thomas A.

    2011-01-01

    The phrase "blind astronomer” is used as an allegorical oxymoron. However, there were and are blind astronomers. What of famous blind astronomers? First, it must be stated that these astronomers were not martyrs to their craft. It is a myth that astronomers blind themselves by observing the Sun. As early as France's William of Saint-Cloud (circa 1290) astronomers knew that staring at the Sun was ill-advised and avoided it. Galileo Galilei did not invent the astronomical telescope and then proceed to blind himself with one. Galileo observed the Sun near sunrise and sunset or through projection. More than two decades later he became blind, as many septuagenarians do, unrelated to their profession. Even Isaac Newton temporarily blinded himself, staring at the reflection of the Sun when he was a twentysomething. But permanent Sun-induced blindness? No, it did not happen. For instance, it was a stroke that left Scotland's James Gregory (1638-1675) blind. (You will remember the Gregorian telescope.) However, he died days later. Thus, blindness little interfered with his occupation. English Abbot Richard of Wallingford (circa 1291 - circa 1335) wrote astronomical works and designed astronomical instruments. He was also blind in one eye. Yet as he further suffered from leprosy, his blindness seems the lesser of Richard's maladies. Perhaps the most famous professionally active, blind astronomer (or almost blind astronomer) is Dominique-Francois Arago (1786-1853), director until his death of the powerful nineteenth-century Paris Observatory. I will share other _ some poignant _ examples such as: William Campbell, whose blindness drove him to suicide; Leonhard Euler, astronomy's Beethoven, who did nearly half of his life's work while almost totally blind; and Edwin Frost, who "observed” a total solar eclipse while completely sightless.

  7. Citalopram for compulsive shopping disorder: an open-label study followed by double-blind discontinuation.

    Science.gov (United States)

    Koran, Lorrin M; Chuong, Helen W; Bullock, Kim D; Smith, S Christine

    2003-07-01

    Open-label trials suggested that fluvoxamine and citalopram may be effective for compulsive shopping disorder, but 2 double-blind fluvoxamine trials failed to confirm this. To test the hypothesis that citalopram is a safe, effective treatment for this disorder, we conducted a 7-week, open-label trial followed by a 9-week, double-blind, placebo-controlled discontinuation trial. From Jan. 2001 to Jan. 2002, we enrolled adult outpatients meeting diagnostic criteria suggested in a prior study for compulsive shopping disorder and having a score of >/= 17 on the Yale-Brown Obsessive Compulsive Scale-Shopping Version (YBOCS-SV). Open-label citalopram was started at 20 mg/day and increased, absent marked response and limiting side effects, to 60 mg/day. Responders (subjects rated "much improved" or "very much improved" on the Clinical Global Impressions-Improvement scale [CGI-I] and having a >/= 50% decrease in YBOCS-SV score) were randomized to double-blind citalopram treatment at the week 7 dose or placebo for 9 weeks. We enrolled 24 subjects (23 women and 1 man). Mean +/- SD YBOCS-SV scores decreased significantly from 24.3 +/- 4.6 at baseline to 8.2 +/- 8.1 at week 7 (Wilcoxon signed rank: z = 4.20, p /= 17 and "minimally improved" or less on the CGI-I) compared with none of 7 randomized to continue taking citalopram (Fisher exact test p =.019). Citalopram appears to be a safe and effective treatment for compulsive shopping disorder. Further trials of citalopram and other selective serotonin reuptake inhibitors are warranted.

  8. Frequency of discrepancies in retracted clinical trial reports versus unretracted reports: blinded case-control study.

    Science.gov (United States)

    Cole, Graham D; Nowbar, Alexandra N; Mielewczik, Michael; Shun-Shin, Matthew J; Francis, Darrel P

    2015-09-20

    To compare the frequency of discrepancies in retracted reports of clinical trials with those in adjacent unretracted reports in the same journal. Blinded case-control study. Journals in PubMed. 50 manuscripts, classified on PubMed as retracted clinical trials, paired with 50 adjacent unretracted manuscripts from the same journals. Reports were randomly selected from PubMed in December 2012, with no restriction on publication date. Controls were the preceding unretracted clinical trial published in the same journal. All traces of retraction were removed. Three scientists, blinded to the retraction status of individual reports, reviewed all 100 trial reports for discrepancies. Discrepancies were pooled and cross checked before being counted into prespecified categories. Only then was the retraction status unblinded for analysis. Total number of discrepancies (defined as mathematically or logically contradictory statements) in each clinical trial report. Of 479 discrepancies found in the 100 trial reports, 348 were in the 50 retracted reports and 131 in the 50 unretracted reports. On average, individual retracted reports had a greater number of discrepancies than unretracted reports (median 4 (interquartile range 2-8.75) v 0 (0-5); Pretracted than those without a discrepancy (odds ratio 5.7 (95% confidence interval 2.2 to 14.5); Pretracted than unretracted reports: factual discrepancies (P=0.002), arithmetical errors (P=0.01), and missed P values (P=0.02). Results from a retrospective analysis indicated that citations and journal impact factor were unlikely to affect the result. Discrepancies in published trial reports should no longer be assumed to be unimportant. Scientists, blinded to retraction status and with no specialist skill in the field, identify significantly more discrepancies in retracted than unretracted reports of clinical trials. Discrepancies could be an early and accessible signal of unreliability in clinical trial reports. © Cole et al 2015.

  9. Adjustable recessions in horizontal comitant strabismus: A pilot study

    Directory of Open Access Journals (Sweden)

    Siddharth Agrawal

    2015-01-01

    Full Text Available Aim: To compare the surgical outcome of adjustable with the conventional recession in patients with horizontal comitant strabismus. Patients and Methods: A prospective comparative nonrandomized interventional pilot study was performed on patients with horizontal comitant strabismus. Fifty-four patients (27 in each group were allocated into 2 groups to undergo either adjustable suture (AS recession or non-AS (NAS recession along with conventional resection. The patients were followed up for 6 months. A successful outcome was defined as deviation ±10 prism diopters at 6 months. The results were statistically analyzed by Chi-square test, Fisher′s exact test, and Student′s t-test. Results: A successful outcome was found in 24 (88.8% patients in AS and 17 (62.9% in NAS group (P = 0.02. The postoperative adjustment was done in 13 (48.1% patients in AS group. There was one complication (tenon′s cyst in AS group. Conclusion: AS recession may be considered in all cooperative patients undergoing strabismus surgery for comitant deviations.

  10. A Problem Solving Intervention for hospice caregivers: a pilot study.

    Science.gov (United States)

    Demiris, George; Oliver, Debra Parker; Washington, Karla; Fruehling, Lynne Thomas; Haggarty-Robbins, Donna; Doorenbos, Ardith; Wechkin, Hope; Berry, Donna

    2010-08-01

    The Problem Solving Intervention (PSI) is a structured, cognitive-behavioral intervention that provides people with problem-solving coping skills to help them face major negative life events and daily challenges. PSI has been applied to numerous settings but remains largely unexplored in the hospice setting. The aim of this pilot study was to demonstrate the feasibility of PSI targeting informal caregivers of hospice patients. We enrolled hospice caregivers who were receiving outpatient services from two hospice agencies. The intervention included three visits by a research team member. The agenda for each visit was informed by the problem-solving theoretical framework and was customized based on the most pressing problems identified by the caregivers. We enrolled 29 caregivers. Patient's pain was the most frequently identified problem. On average, caregivers reported a higher quality of life and lower level of anxiety postintervention than at baseline. An examination of the caregiver reaction assessment showed an increase of positive esteem average and a decrease of the average value of lack of family support, impact on finances, impact on schedules, and on health. After completing the intervention, caregivers reported lower levels of anxiety, improved problem solving skills, and a reduced negative impact of caregiving. Furthermore, caregivers reported high levels of satisfaction with the intervention, perceiving it as a platform to articulate their challenges and develop a plan to address them. Findings demonstrate the value of problem solving as a psycho-educational intervention in the hospice setting and call for further research in this area.

  11. Building Resiliency in a Palliative Care Team: A Pilot Study.

    Science.gov (United States)

    Mehta, Darshan H; Perez, Giselle K; Traeger, Lara; Park, Elyse R; Goldman, Roberta E; Haime, Vivian; Chittenden, Eva H; Denninger, John W; Jackson, Vicki A

    2016-03-01

    Palliative care clinicians (PCCs) are vulnerable to burnout as a result of chronic stress related to working with seriously ill patients. Burnout can lead to absenteeism, ineffective communication, medical errors, and job turnover. Interventions that promote better coping with stress are needed in this population. This pilot study tested the feasibility of the Relaxation Response Resiliency Program for Palliative Care Clinicians, a program targeted to decrease stress and increase resiliency, in a multidisciplinary cohort of PCCs (N = 16) at a major academic medical center. A physician delivered the intervention over two months in five sessions (12 hours total). Data were collected the week before the program start and two months after completion. The main outcome was feasibility of the program. Changes in perceived stress, positive and negative affect, perspective taking, optimism, satisfaction with life, and self-efficacy were examined using nonparametric statistical tests. Effect size was quantified using Cohen's d. The intervention was feasible; all participants attended at least four of the five sessions, and there was no attrition. After the intervention, participants showed reductions in perceived stress and improvements in perspective taking. Our findings suggest that a novel team-based resiliency intervention based on elicitation of the relaxation response was feasible and may help promote resiliency and protect against the negative consequences of stress for PCCs. Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

  12. Perceived harmfulness of substance use: A pilot study

    Directory of Open Access Journals (Sweden)

    Siddharth Sarkar

    2014-01-01

    Full Text Available Background: Harm ratings of substances help in understanding the perception toward substance use and formulating policies. Evidence of such harm ratings by substance users and their caregivers provides a clearer perspective of those who experience and observe such harm closely. Materials and Methods: Substance users and their caregivers were recruited from the Drug De-addiction and Treatment Centre of PGIMER, Chandigarh. Sociodemographic details of the subjects were noted. The subjects were then asked to rate a list of psychoactive preparations according to the harms they thought the preparation caused. The list of substances was developed taking into consideration substance commonly encountered in the geographical area. The harm ratings were transformed on a scale of 0-100. Results: All subjects were males and majority of them were educated above 10 th standard, were not employed and belonged to urban background. Most of them had taken psychoactive substances in their lifetimes but were currently abstinent. Most of the subjects endorsed intravenous drugs as the most harmful, followed by heroin. Beer and chewable tobacco considered the least harmful substances. Greater degree of education was associated with lower harm rankings for heroin, cannabis, dextropropoxyphene, and raw opium; while urban residence was associated with greater harm ratings for cannabis and raw opium. Differences in the harms were perceived for different preparations of the same active compound for alcohol and nicotine. Conclusion: Harm ratings of substances can be a useful guide while formulating policies and allocating resources. Need for further research extending this pilot study is emphasized.

  13. Evaluating and operationalizing an environmental auditing program: a pilot study.

    Science.gov (United States)

    Gordon, Laura; Bruce, Natalie; Suh, Kathryn N; Roth, Virginia

    2014-07-01

    Environmental auditing is an important tool to ensure consistent and effective cleaning. Our pilot study compared an alcohol-based fluorescent marking product and an adenosine-5'-triphosphate bioluminescence product for use in an environmental auditing program to determine which product was more practical and acceptable to users. Both products were tested on 15 preselected high touch objects in randomly selected patient rooms, following regular daily cleaning. A room was considered a "pass" if ≥80% of surfaces were adequately cleaned as defined by manufacturers' guidelines. A qualitative survey assessed user preference and operational considerations. Using fluorescent marking, 9 of 37 patient rooms evaluated (24%) were considered a "pass" after daily cleaning. Using adenosine-5'-triphosphate bioluminescence, 21 of 37 patient rooms passed (57%). There was great variability in results between different high touch objects. Eighty percent of users preferred the alcohol-based fluorescent marking product because it provided an effective visual aid to coach staff on proper cleaning techniques and allowed simple and consistent application. Environmental auditing using translucent, alcohol-based fluorescent marking best met the requirements of our organization. Our results reinforce the importance of involving a multidisciplinary team in evaluating and operationalizing an environmental auditing program. Copyright © 2014 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

  14. Intensive mothering ideology in France: A pilot study.

    Science.gov (United States)

    Loyal, D; Sutter Dallay, A-L; Rascle, N

    2017-12-01

    The aim of this pilot study was to adapt the intensive mothering ideology concept in a French sample and to get an assessment tool. First, the Intensive Parenting Attitudes Questionnaire (IPAQ), a U.S. scale comprising 25 items, was translated and submitted online to French mothers and mothers-to-be (n=250). Structural validity was tested through confirmatory factor analysis with poor results. Secondly, to increase the cultural validity of a new tool, new items were derived from French women speech. French mothers and mothers-to-be (n=22) were asked about their views regarding motherhood and childcare (semi-structured interviews). A thematic content analysis was performed with good inter-judge agreement (0.53-0.86) and 27 items were created. Finally, the total set of 52 items was submitted online to French mothers and mothers-to-be (n=474). The structure was tested through exploratory factor analysis. A new tool called the Measure of Intensive Mothering Ideology (MIMI) was obtained. This 21 items scale with 6 dimensions (Essentialism, Consuming Fulfillment, Child-centrism, Challenge, Sacrifice and Stimulation) explains 59.75% of variance. Internal consistencies were satisfactory (0.61-0.83) and most dimensions were positively and moderately correlated (0.17-0.38). The MIMI is the first French-language scale assessing IMI and offers interesting research avenues notably regarding perinatal parental adaptation. Copyright © 2017 L'Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

  15. Lucid dreaming treatment for nightmares: a pilot study.

    Science.gov (United States)

    Spoormaker, Victor I; van den Bout, Jan

    2006-01-01

    The goal of this pilot study was to evaluate the effects of the cognitive-restructuring technique 'lucid dreaming treatment' (LDT) on chronic nightmares. Becoming lucid (realizing that one is dreaming) during a nightmare allows one to alter the nightmare storyline during the nightmare itself. After having filled out a sleep and a posttraumatic stress disorder questionnaire, 23 nightmare sufferers were randomly divided into 3 groups; 8 participants received one 2-hour individual LDT session, 8 participants received one 2-hour group LDT session, and 7 participants were placed on the waiting list. LDT consisted of exposure, mastery, and lucidity exercises. Participants filled out the same questionnaires 12 weeks after the intervention (follow-up). At follow-up the nightmare frequency of both treatment groups had decreased. There were no significant changes in sleep quality and posttraumatic stress disorder symptom severity. Lucidity was not necessary for a reduction in nightmare frequency. LDT seems effective in reducing nightmare frequency, although the primary therapeutic component (i.e. exposure, mastery, or lucidity) remains unclear.

  16. Compensatory stepping responses in individuals with stroke: a pilot study.

    Science.gov (United States)

    Lakhani, Bimal; Mansfield, Avril; Inness, Elizabeth L; McIlroy, William E

    2011-05-01

    Impaired postural control and a high incidence of falls are commonly observed following stroke. Compensatory stepping responses are critical to reactive balance control. We hypothesize that, following a stroke, individuals with unilateral limb dyscontrol will be faced with the unique challenge of controlling such rapid stepping reactions that may eventually be linked to the high rate of falling. The objectives of this exploratory pilot study were to investigate compensatory stepping in individuals poststroke with regard to: (1) choice of initial stepping limb (paretic or non-paretic); (2) step characteristics; and (3) differences in step characteristics when the initial step is taken with the paretic vs. the non-paretic limb. Four subjects following stroke (38-165 days post) and 11 healthy young adults were recruited. Anterior and posterior perturbations were delivered by using a weight drop system. Force plates recorded centre-of-pressure excursion prior to the onset of stepping and step timing. Of the four subjects, three only attempted to step with their non-paretic limb and one stepped with either limb. Time to foot-off was generally slow, whereas step onset time and swing time were comparable to healthy controls. Two of the four subjects executed multistep responses in every trial, and attempts to force stepping with the paretic limb were unsuccessful in three of the four subjects. Despite high clinical balance scores, these individuals with stroke demonstrated impaired compensatory stepping responses, suggesting that current clinical evaluations might not accurately reflect reactive balance control in this population.

  17. Sociomoral Reasoning in Adults with ADHD: A Pilot Study

    Directory of Open Access Journals (Sweden)

    Kate E. Thomason

    2014-08-01

    Full Text Available Attention Deficit Hyperactivity Disorder (ADHD is frequently linked with antisocial behaviour, yet less is known about its relationship with sociomoral reasoning, and the possible mediating effect of intelligence. A pilot study was designed to investigate the relationship between antisocial personality traits, intelligence and sociomoral reasoning in adults with ADHD. Twenty two adults with ADHD and 21 healthy controls, matched for age, gender and IQ completed a battery of measures including the National Adult Reading Test, Gough Socialisation Scale and Sociomoral Reflection Measure-Short Form. There was no difference between the groups and levels of sociomoral reasoning, despite the ADHD group reporting greater antisocial personality traits. Sociomoral reasoning was positively correlated with intelligence. Results from a hierarchical multiple regressions indicated that both antisocial traits and IQ were significant predictors of sociomoral reasoning, with IQ proving the most powerful predictor. Whilst antisocial personality traits may explain some of the variance in levels of sociomoral reasoning, a diagnosis of ADHD does not appear to hinder the development of mature moral reasoning. Intellectual functioning appears to facilitate the development of sociomoral reasoning. A further analysis showed that both ADHD and low sociomoral reasoning were significant predictors of antisocial traits. The current findings have important treatment implications.

  18. 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.

  19. Effects of Aquajogging in Obese Adults: A Pilot Study

    Directory of Open Access Journals (Sweden)

    Eveline J. M. Wouters

    2010-01-01

    Full Text Available Aim and Method. To examine in obese people the potential effectiveness of a six-week, two times weekly aquajogging program on body composition, fitness, health-related quality of life, and exercise beliefs. Fifteen otherwise healthy obese persons participated in a pilot study. Results. Total fat mass and waist circumference decreased 1.4 kg (P=.03 and 3.1 cm (P=.005, respectively. The distance in the Six-Minute Walk Test increased 41 meters (P=.001. Three scales of the Impact of Weight on Quality of Life-Lite questionnaire improved: physical function (P=.008, self-esteem (P=.004, and public distress (P=.04. Increased perceived exercise benefits (P=.02 and decreased embarrassment (P=.03 were observed. Conclusions. Aquajogging was associated with reduced body fat and waist circumference and improved aerobic fitness and quality of life. These findings suggest the usefulness of conducting a randomized controlled trial with long-term outcome assessments.

  20. Metastability in plyometric training on unstable surfaces: a pilot study

    Science.gov (United States)

    2014-01-01

    Background In the past, plyometric training (PT) has been predominantly performed on stable surfaces. The purpose of this pilot study was to examine effects of a 7-week lower body PT on stable vs. unstable surfaces. This type of exercise condition may be denoted as metastable equilibrium. Methods Thirty-three physically active male sport science students (age: 24.1 ± 3.8 years) were randomly assigned to a PT group (n = 13) exercising on stable (STAB) and a PT group (n = 20) on unstable surfaces (INST). Both groups trained countermovement jumps, drop jumps, and practiced a hurdle jump course. In addition, high bar squats were performed. Physical fitness tests on stable surfaces (hexagonal obstacle test, countermovement jump, hurdle drop jump, left-right hop, dynamic and static balance tests, and leg extension strength) were used to examine the training effects. Results Significant main effects of time (ANOVA) were found for the countermovement jump, hurdle drop jump, hexagonal test, dynamic balance, and leg extension strength. A significant interaction of time and training mode was detected for the countermovement jump in favor of the INST group. No significant improvements were evident for either group in the left-right hop and in the static balance test. Conclusions These results show that lower body PT on unstable surfaces is a safe and efficient way to improve physical performance on stable surfaces. PMID:25089202

  1. Acute Modulation of Brain Connectivity in Parkinson Disease after Automatic Mechanical Peripheral Stimulation: A Pilot Study.

    Science.gov (United States)

    Quattrocchi, Carlo Cosimo; de Pandis, Maria Francesca; Piervincenzi, Claudia; Galli, Manuela; Melgari, Jean Marc; Salomone, Gaetano; Sale, Patrizio; Mallio, Carlo Augusto; Carducci, Filippo; Stocchi, Fabrizio

    2015-01-01

    The present study shows the results of a double-blind sham-controlled pilot trial to test whether measurable stimulus-specific functional connectivity changes exist after Automatic Mechanical Peripheral Stimulation (AMPS) in patients with idiopathic Parkinson Disease. Eleven patients (6 women and 5 men) with idiopathic Parkinson Disease underwent brain fMRI immediately before and after sham or effective AMPS. Resting state Functional Connectivity (RSFC) was assessed using the seed-ROI based analysis. Seed ROIs were positioned on basal ganglia, on primary sensory-motor cortices, on the supplementary motor areas and on the cerebellum. Individual differences for pre- and post-effective AMPS and pre- and post-sham condition were obtained and first entered in respective one-sample t-test analyses, to evaluate the mean effect of condition. Effective AMPS, but not sham stimulation, induced increase of RSFC of the sensory motor cortex, nucleus striatum and cerebellum. Secondly, individual differences for both conditions were entered into paired group t-test analysis to rule out sub-threshold effects of sham stimulation, which showed stronger connectivity of the striatum nucleus with the right lateral occipital cortex and the cuneal cortex (max Z score 3.12) and with the right anterior temporal lobe (max Z score 3.42) and of the cerebellum with the right lateral occipital cortex and the right cerebellar cortex (max Z score 3.79). Our results suggest that effective AMPS acutely increases RSFC of brain regions involved in visuo-spatial and sensory-motor integration. This study provides Class II evidence that automatic mechanical peripheral stimulation is effective in modulating brain functional connectivity of patients with Parkinson Disease at rest. Clinical Trials.gov NCT01815281.

  2. Acute Modulation of Brain Connectivity in Parkinson Disease after Automatic Mechanical Peripheral Stimulation: A Pilot Study

    Science.gov (United States)

    Piervincenzi, Claudia; Galli, Manuela; Melgari, Jean Marc; Salomone, Gaetano; Sale, Patrizio; Mallio, Carlo Augusto; Carducci, Filippo; Stocchi, Fabrizio

    2015-01-01

    Objective The present study shows the results of a double-blind sham-controlled pilot trial to test whether measurable stimulus-specific functional connectivity changes exist after Automatic Mechanical Peripheral Stimulation (AMPS) in patients with idiopathic Parkinson Disease. Methods Eleven patients (6 women and 5 men) with idiopathic Parkinson Disease underwent brain fMRI immediately before and after sham or effective AMPS. Resting state Functional Connectivity (RSFC) was assessed using the seed-ROI based analysis. Seed ROIs were positioned on basal ganglia, on primary sensory-motor cortices, on the supplementary motor areas and on the cerebellum. Individual differences for pre- and post-effective AMPS and pre- and post-sham condition were obtained and first entered in respective one-sample t-test analyses, to evaluate the mean effect of condition. Results Effective AMPS, but not sham stimulation, induced increase of RSFC of the sensory motor cortex, nucleus striatum and cerebellum. Secondly, individual differences for both conditions were entered into paired group t-test analysis to rule out sub-threshold effects of sham stimulation, which showed stronger connectivity of the striatum nucleus with the right lateral occipital cortex and the cuneal cortex (max Z score 3.12) and with the right anterior temporal lobe (max Z score 3.42) and of the cerebellum with the right lateral occipital cortex and the right cerebellar cortex (max Z score 3.79). Conclusions Our results suggest that effective AMPS acutely increases RSFC of brain regions involved in visuo-spatial and sensory-motor integration. Classification of Evidence This study provides Class II evidence that automatic mechanical peripheral stimulation is effective in modulating brain functional connectivity of patients with Parkinson Disease at rest. Trial Registration Clinical Trials.gov NCT01815281 PMID:26469868

  3. Prevalence and Severity of Dysphonia in Patients with Cystic Fibrosis: A Pilot Study.

    Science.gov (United States)

    Willis, John; Michael, Deirdre D; Boyer, Holly; Misono, Stephanie

    2015-07-01

    To assess the prevalence and severity of dysphonia in patients with cystic fibrosis sinusitis. We hypothesized that patients with CF sinusitis, compared with 2 control groups, would have higher self-reported prevalence of dysphonia and greater severity of dysphonia, according to patient-reported outcome measures as well as auditory-perceptual evaluation by expert listeners. Cross-sectional comparative pilot study. Academic tertiary care clinic. Analysis included 37 study participants: 17 patients with CF sinusitis, 10 healthy individuals, and 10 patients with non-CF sinusitis. All participants completed the 10-item Voice Handicap Index (VHI-10) questionnaire and provided voice samples. On all samples, 6 blinded speech-language pathologists independently performed auditory-perceptual evaluation, using Consensus Auditory-Perceptual Evaluation of Voice. To assess severity of sinonasal symptoms, we used the 20-item Sinonasal Outcome Test (SNOT-20). Standard parametric and nonparametric statistical analysis was performed. The differences between the 3 groups in prevalence of abnormal VHI-10 scores were not statistically significant. SNOT-20 scores were similar in the 2 sinusitis patient groups. VHI-10 scores were highest in patients with CF sinusitis, intermediate in patients with non-CF sinusitis, and lowest in healthy individuals (P = .005). Auditory-perceptual evaluation demonstrated greater overall severity of dysphonia in patients with CF sinusitis compared with the 2 control groups (P = .0005). Cystic fibrosis sinusitis appeared to be associated with worse vocal function as measured by patient self-report as well as auditory-perceptual evaluation of voice compared with patients with non-CF sinusitis and healthy controls. Further investigation in this area is warranted. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2015.

  4. Blinding in randomized controlled trials in general and abdominal surgery: protocol for a systematic review and empirical study.

    Science.gov (United States)

    Probst, Pascal; Grummich, Kathrin; Heger, Patrick; Zaschke, Steffen; Knebel, Phillip; Ulrich, Alexis; Büchler, Markus W; Diener, Markus K

    2016-03-24

    Blinding is a measure in randomized controlled trials (RCT) to reduce detection and performance bias. There is evidence that lack of blinding leads to overestimated treatment effects. Because of the physical component of interventions, blinding is not easily applicable in surgical trials. This is a protocol for a systematic review and empirical study about actual impact on outcomes and future potential of blinding in general and abdominal surgery RCT. A systematic literature search in CENTRAL, MEDLINE and Web of Science will be conducted to locate RCT between 1996 and 2015 with a surgical intervention. General study characteristics and information on blinding methods will be extracted. The risk of performance and detection bias will be rated as low, unclear or high according to the Cochrane Collaboration's tool for assessing risk of bias. The main outcome of interest will be the association of a high risk of performance or detection bias with significant trial results and will be tested at a level of significance of 5 %. Further, trials will be meta-analysed in a Mantel-Haenszel model comparing trials with high risk of bias to other trials at a level of significance of 5 %. Detection and performance bias distort treatment effects. The degree of such bias in general and abdominal surgery is unknown. Evidence on influence of missing blinding would improve critical appraisal and conduct of general and abdominal surgery RCT. PROSPERO 2015: CRD42015026837.

  5. A pilot study of workplace violence towards paramedics

    Science.gov (United States)

    Boyle, Malcolm; Koritsas, Stella; Coles, Jan; Stanley, Janet

    2007-01-01

    Background International studies have shown that some 60% of paramedics have experienced physical violence in the workplace, and between 21–78% have experienced verbal abuse. To date, there is no Australian literature describing Australian paramedics' experience of workplace violence. Objective To identify the percentage of paramedics who had experienced six different forms of workplace violence. Methods A questionnaire was developed to explore paramedics' experience of workplace violence. Six forms of violence were included: verbal abuse, property damage or theft, intimidation, physical abuse, sexual harassment, and sexual assault. The questionnaire also included a series of demographic questions. The questionnaire was piloted using a reference group and changes made accordingly. The questionnaire was distributed to 500 rural Victorian paramedics and 430 metropolitan South Australian paramedics. Ethics approval was granted for this study. Results The overall response rate was 28%, with 75% being male and 25% female. The median age of respondents was 40.7 years, range 21–62 years. The median number of years experience as a paramedic was 14.3 years, range 6 months to 39 years. There were 87.5% of paramedics exposed to workplace violence. Verbal abuse was the most prevalent form of workplace violence (82%), with intimidation (55%), physical abuse (38%), sexual harassment (17%), and sexual assault (4%). Conclusion This study lays the foundation for further studies investigating paramedic experience of workplace violence. This study demonstrates that workplace violence is prevalent for paramedics and highlights the need for prevention and education within the profession. PMID:17954828

  6. A pilot study to delimit tsetse target populations in Zimbabwe.

    Directory of Open Access Journals (Sweden)

    Gerald Chikowore

    2017-05-01

    Full Text Available Tsetse (Glossina sensu stricto are cyclical vectors of human and animal trypanosomoses, that are presently targeted by the Pan African Tsetse and Trypanosomiasis Eradication Campaign (PATTEC coordinated by the African Union. In order to achieve effective control of tsetse, there is need to produce elaborate plans to guide intervention programmes. A model intended to aid in the planning of intervention programmes and assist a fuller understanding of tsetse distribution was applied, in a pilot study in the Masoka area, Mid-Zambezi valley in Zimbabwe, and targeting two savannah species, Glossina morsitans morsitans and Glossina pallidipes.The field study was conducted between March and December 2015 in 105 sites following a standardized grid sampling frame. Presence data were used to study habitat suitability of both species based on climatic and environmental data derived from MODIS and SPOT 5 satellite images. Factors influencing distribution were studied using an Ecological Niche Factor Analysis (ENFA whilst habitat suitability was predicted using a Maximum Entropy (MaxEnt model at a spatial resolution of 250 m. Area Under the Curve (AUC, an indicator of model performance, was 0.89 for G. m. morsitans and 0.96 for G. pallidipes. We then used the predicted suitable areas to calculate the probability that flies were really absent from the grid cells where they were not captured during the study based on a probability model using a risk threshold of 0.05. Apart from grid cells where G. m. morsitans and G. pallidipes were captured, there was a high probability of presence in an additional 128 km2 and 144 km2 respectively.The modelling process promised to be useful in optimizing the outputs of presence/absence surveys, allowing the definition of tsetse infested areas with improved accuracy. The methodology proposed here can be extended to all the tsetse infested parts of Zimbabwe and may also be useful for other PATTEC national initiatives in other

  7. A pilot study of motivational interviewing training in a virtual world.

    Science.gov (United States)

    Mitchell, Suzanne; Heyden, Robin; Heyden, Neil; Schroy, Paul; Andrew, Stephen; Sadikova, Ekaterina; Wiecha, John

    2011-09-26

    Motivational interviewing (MI) is an evidence-based, patient-centered counseling strategy proven to support patients seeking health behavior change. Yet the time and travel commitment for MI training is often a barrier to the adoption of MI by health care professionals. Virtual worlds such as Second Life (SL) are rapidly becoming part of the educational technology landscape and offer not only the potential to improve access to MI training but also to deepen the MI training experience through the use of immersive online environments. Despite SL's potential for medical education applications, little work is published studying its use for this purpose and still less is known of educational outcomes for physician training in MI using a virtual-world platform. Our aims were to (1) explore the feasibility, acceptability, and effectiveness of a virtual-world platform for delivering MI training designed for physicians and (2) pilot test instructional designs using SL for MI training. We designed and pilot tested an MI training program in the SL virtual world. We trained and enrolled 13 primary care physicians in a two-session, interactive program in SL on the use of MI for counseling patients about colorectal cancer screening. We measured self-reported changes in confidence and clinical practice patterns for counseling on colorectal cancer screening, and acceptability of the virtual-world learning environment and the MI instructional design. Effectiveness of the MI training was assessed by coding and scoring tape-recorded interviews with a blinded mock patient conducted pre- and post-training. A total of 13 physicians completed the training. Acceptability ratings for the MI training ranged from 4.1 to 4.7 on a 5-point scale. The SL learning environment was also highly rated, with 77% (n = 10) of the doctors reporting SL to be an effective educational medium. Learners' confidence and clinical practice patterns for colorectal cancer screening improved after training. Pre- to

  8. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework.

    Directory of Open Access Journals (Sweden)

    Sandra M Eldridge

    Full Text Available We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of pilot and feasibility studies. However, some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions. Their viewpoint was supported by definitions outside the health research context, the use of the terms 'pilot' and 'feasibility' in the literature, and participants at the international consensus meeting. In our framework, pilot studies are a subset of feasibility studies, rather than the two being mutually exclusive. A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale. We suggest that to facilitate their identification, these studies should be clearly identified using the terms 'feasibility' or 'pilot' as appropriate. This should include feasibility studies that are largely qualitative; we found these difficult to identify in electronic searches because researchers rarely used the term 'feasibility' in the title or abstract of such studies. Investigators should also report appropriate objectives and methods related to feasibility; and give clear confirmation that their study is in preparation for a future randomised controlled trial designed to assess the effect of an intervention.

  9. Effects of Taping on Pain and Functional Outcome of Patients with Knee Osteoarthritis: A Pilot Randomized Single-blind Clinical Trial

    Directory of Open Access Journals (Sweden)

    Parisa Taheri

    2017-01-01

    Full Text Available Background: To determine the effects of knee taping in combination with exercise and medical treatment on functional outcome and pain of patients with knee osteoarthritis (OA. Materials and Methods: In a randomized single-blinded clinical trial, 36 patients with knee OA were randomly assigned to two study groups. Both groups received exercise and medical therapy for 6 weeks. In addition, the first group (20 patients received taping in the first 3 weeks. Pain severity (assessed by visual analog scaling, weekly amount of analgesics consumption, timed get up and go test (TUG, and step tests were recorded at baseline, 3 and 6 weeks after the treatment and were further compared between two study groups. Results: There was no significant difference between two groups in pain severity score (P = 0.228, step test score (P = 0.771, TUG test score (P = 0.821 and weekly amount of analgesics consumption (P = 0.873 at baseline. After 3 weeks, weekly amount of analgesics consumption (P = 0.006, pain severity (P < 0.001 was significantly lower in taping group whereas step test score (P = 0.006 was significantly higher in the taping group. After 6 weeks, patients in taping group had significantly lower pain severity (P = 0.011 and higher step test score (P = 0.042. However, there was no significant difference in TUG test score (P = 0.443 and weekly amount of analgesics consumption (P = 0.270 between two groups. Conclusion: Therapeutic knee taping may be an effective method for short-term management of pain and disability in patients with knee OA.

  10. Free online otolaryngology educational modules: a pilot study.

    Science.gov (United States)

    Cabrera-Muffly, Cristina; Bryson, Paul C; Sykes, Kevin J; Shnayder, Yelizaveta

    2015-04-01

    Otolaryngology residents need concise, easily accessible modules to expand educational opportunities between surgical cases. These modules should be inexpensive to create and improve learning outcomes. The purpose of this pilot study was to assess whether otolaryngology residents at multiple institutions used online video modules to supplement their studying for the Otolaryngology Training Exam, whether the modules had any effect on their Otolaryngology Training Examination Scores, and to obtain survey feedback about the modules. This randomized trial was conducted in 3 academic departments of otolaryngology in the United States among 37 residents enrolled in 3 otolaryngology residency programs. Residents were randomized into 2 groups, one with access to the educational modules and the other with no access. Otolaryngology training examination scores were obtained from the year prior to the intervention (2012) and the year following module access (2013). Residents with access to the modules were also surveyed to assess use and obtain feedback about the modules. Otolaryngology training examination scores improved significantly from 2012 to 2013 among both residents who had access to the modules and those who did not in the sections of head and neck, laryngology, and sleep medicine. However, scores in the sections of pediatric otolaryngology (8% increase, P = .03), otology (7% increase, P = .02), and facial plastic surgery (10% increase, P = .02) improved from 2012 to 2013 only among residents with access to the modules. All respondents rated the videos as very helpful, with a rating of 4 of 5 on a Likert scale. Online otolaryngology educational modules are an inexpensive way to expand resident learning opportunities. Despite the lack of quantifiable improvement in otolaryngology training examination scores in this study, use of online modules sends a message to otolaryngology residents that their education is a priority; self-study outside the hospital

  11. Probabilistic Tsunami Hazard Assessment: the Seaside, Oregon Pilot Study

    Science.gov (United States)

    Gonzalez, F. I.; Geist, E. L.; Synolakis, C.; Titov, V. V.

    2004-12-01

    A pilot study of Seaside, Oregon is underway, to develop methodologies for probabilistic tsunami hazard assessments that can be incorporated into Flood Insurance Rate Maps (FIRMs) developed by FEMA's National Flood Insurance Program (NFIP). Current NFIP guidelines for tsunami hazard assessment rely on the science, technology and methodologies developed in the 1970s; although generally regarded as groundbreaking and state-of-the-art for its time, this approach is now superseded by modern methods that reflect substantial advances in tsunami research achieved in the last two decades. In particular, post-1990 technical advances include: improvements in tsunami source specification; improved tsunami inundation models; better computational grids by virtue of improved bathymetric and topographic databases; a larger database of long-term paleoseismic and paleotsunami records and short-term, historical earthquake and tsunami records that can be exploited to develop improved probabilistic methodologies; better understanding of earthquake recurrence and probability models. The NOAA-led U.S. National Tsunami Hazard Mitigation Program (NTHMP), in partnership with FEMA, USGS, NSF and Emergency Management and Geotechnical agencies of the five Pacific States, incorporates these advances into site-specific tsunami hazard assessments for coastal communities in Alaska, California, Hawaii, Oregon and Washington. NTHMP hazard assessment efforts currently focus on developing deterministic, "credible worst-case" scenarios that provide valuable guidance for hazard mitigation and emergency management. The NFIP focus, on the other hand, is on actuarial needs that require probabilistic hazard assessments such as those that characterize 100- and 500-year flooding events. There are clearly overlaps in NFIP and NTHMP objectives. NTHMP worst-case scenario assessments that include an estimated probability of occurrence could benefit the NFIP; NFIP probabilistic assessments of 100- and 500-yr

  12. Study of the CMS Phase 1 Pixel Pilot Blade Reconstruction

    CERN Document Server

    CMS Collaboration

    2017-01-01

    The silicon pixel detector is the innermost component of the CMS tracking system. It was replaced in March 2017 with an upgraded one, called the Phase 1 upgrade detector. During Long Shutdown 1, a third disk was inserted into the present forward pixel detector with eight prototype blades constructed using a new digital read-out chip architecture and a prototype readout chain. Testing the performance of these pilot modules enabled us to gain experience with the Phase 1 upgrade modules. In this document, the data reconstruction with the pilot system is presented. The hit finding efficiency and residual of these new modules is also shown, and how these observables were used to adjust the timing of the pilot blades.

  13. An experimental study of human pilot's scanning behavior

    Science.gov (United States)

    Washizu, K.; Tanaka, K.; Osawa, T.

    1982-01-01

    The scanning behavior and the control behavior of the pilot who manually controls the two-variable system, which is the most basic one of multi-variable systems are investigated. Two control tasks which simulate the actual airplane attitude and airspeed control were set up. In order to simulate the change of the situation where the pilot is placed, such as changes of flight phase, mission and others, the subject was requested to vary the weightings, as his control strategy, upon each task. Changes of human control dynamics and his canning properties caused by the modification of the situation were investigated. By making use of the experimental results, the optimal model of the control behavior and the scanning behavior of the pilot in the two-variable system is proposed from the standpoint of making the performance index minimal.

  14. Drinking Rainwater: A Double-Blinded, Randomized Controlled Study of Water Treatment Filters and Gastroenteritis Incidence

    Science.gov (United States)

    Rodrigo, Shelly; Sinclair, Martha; Forbes, Andrew; Cunliffe, David

    2011-01-01

    Objectives. We examined whether drinking untreated rainwater, a practice that is on the rise in developed countries because of water shortages, contributes to community gastroenteritis incidence. Methods. We conducted a double-blinded, randomized controlled trial in Adelaide, Australia. Sham or active water treatment units were installed, and participants recorded incidences of illness in a health diary for 12 months. The primary outcome was highly credible gastroenteritis (HCG; characterized by a specified number of loose stools or vomiting alone or in combination with abdominal pain or nausea in a 24-hour period), and we used generalized estimating equations to account for correlations between numbers of HCG events for individuals in the same family. Results. Participants reported 769 episodes during the study (0.77 episodes/person/year), with an HCG incidence rate ratio (active vs sham) of 1.05 (95% confidence interval [CI] = 0.82, 1.33). Blinding of the participants was effective (index = 0.65; 95% CI = 0.58, 0.72). Conclusions. Our results suggest that consumption of untreated rainwater does not contribute appreciably to community gastroenteritis. However, our findings may not be generalizable to susceptible and immunocompromised persons because these groups were specifically excluded from the study. PMID:20724681

  15. Bilingual Text4Walking Food Service Employee Intervention Pilot Study.

    Science.gov (United States)

    Buchholz, Susan Weber; Ingram, Diana; Wilbur, JoEllen; Fogg, Louis; Sandi, Giselle; Moss, Angela; Ocampo, Edith V

    2016-06-01

    Half of all adults in the United States do not meet the level of recommended aerobic physical activity. Physical activity interventions are now being conducted in the workplace. Accessible technology, in the form of widespread usage of cell phones and text messaging, is available for promoting physical activity. The purposes of this study, which was conducted in the workplace, were to determine (1) the feasibility of implementing a bilingual 12-week Text4Walking intervention and (2) the effect of the Text4Walking intervention on change in physical activity and health status in a food service employee population. Before conducting the study reported here, the Text4Walking research team developed a database of motivational physical activity text messages in English. Because Hispanic or Latino adults compose one-quarter of all adults employed in the food service industry, the Text4Walking team translated the physical activity text messages into Spanish. This pilot study was guided by the Physical Activity Health Promotion Framework and used a 1-group 12-week pre- and posttest design with food service employees who self-reported as being sedentary. The aim of the study was to increase the number of daily steps over the baseline by 3000 steps. Three physical activity text messages were delivered weekly. In addition, participants received 3 motivational calls during the study. SPSS version 19.0 and R 3.0 were used to perform the data analysis. There were 33 employees who participated in the study (57.6% female), with a mean age of 43.7 years (SD 8.4). The study included 11 Hispanic or Latino participants, 8 of whom requested that the study be delivered in Spanish. There was a 100% retention rate in the study. At baseline, the participants walked 102 (SD 138) minutes/day (per self-report). This rate increased significantly (P=.008) to 182 (SD 219) minutes/day over the course of the study. The participants had a baseline mean of 10,416 (SD 5097) steps, which also increased

  16. Comparison of three manual coccydynia treatments: a pilot study.

    Science.gov (United States)

    Maigne, J Y; Chatellier, G

    2001-10-15

    A prospective pilot study with independent assessment and a 2-year follow-up period was conducted. To compare and assess the efficacy of three manual coccydynia treatments, and to identify factors predictive of a good outcome. Various manual medicine treatments have been described in the literature. In an open study, the addition of manipulation to injection treatment produced a 25% increase in satisfactory results. Dynamic radiographs of the coccyx allow breakdown of coccydynia into four etiologic groups based on coccygeal mobility: luxation, hypermobility, immobility, and normal mobility. These groups may respond differently to manual treatments. The patients were randomized into three groups, each of which received three to four sessions of a different treatment: levator anus massage, joint mobilization, or mild levator stretch. Assessment with a visual analog scale was performed by an independent observer at 7 days, 30 days, 6 months, and 2 years. The results of the manual treatments were satisfactory for 25.7% of the cases at 6 months, and for 24.3% of the cases at 2 years. The results varied with the cause of the coccydynia. The patients with an immobile coccyx had the poorest results, whereas those with a normally mobile coccyx fared the best. The patients with luxation or hypermobility had results somewhere between these two rates. Levator anus massage and stretch were more effective than joint mobilization, which worked only for patients with a normally mobile coccyx. Pain when patients stood up from sitting and excessive levator tone were associated with a good outcome. However, none of the results was significant because of the low success rate associated with manual treatment. There is a need for a placebo-controlled study to establish conclusively whether manual treatments are effective. This placebo must be an external treatment. A sample size of 190 patients would be required for 80% confidence in detecting a difference.

  17. Diet and polycystic kidney disease: A pilot intervention study.

    Science.gov (United States)

    Taylor, Jacob M; Hamilton-Reeves, Jill M; Sullivan, Debra K; Gibson, Cheryl A; Creed, Catherine; Carlson, Susan E; Wesson, Donald E; Grantham, Jared J

    2017-04-01

    Dietary sodium, protein, acid precursors, and water have been linked to cyst growth in polycystic kidney disease; yet, no studies in patients have examined the feasibility of using a dietary intervention that controls all of these factors. The aim of this study was to determine if a diet, appropriate for persons of most ages, reduces the excretion of sodium, urea, acid, and decreases mean urine osmolality while gaining acceptance by patients with autosomal dominant polycystic kidney disease (ADPKD). Twelve adults with ADPKD enrolled in a pre-post pilot feasibility study and served as their own controls. Individuals consumed their usual diet for one week then for four weeks followed an isocaloric diet lower in sodium and protein and higher in fruits, vegetables, and water. Three-day diet records and two 24-h urine samples were collected at baseline, week 2, and week 4 visits; blood pressure, weight, and serum were obtained at all three visits. A modified nutrition hassles questionnaire was completed on the last visit. During the dietary intervention, subjects (n = 11) consumed less sodium, protein, and dietary acid precursors 36%, 28%, and 99%, respectively, and increased fluid intake by 42%. Urinary sodium, urea, net acid excretion, osmoles, and osmolality decreased 20%, 28%, 20%, 37%, and 15%, respectively; volume increased 35%. Urine changes were in accord with the diet record. Ninety-one percent of participants reported that none of the hassles were worse than "somewhat severe", and most participants felt "somewhat confident" or "very confident" that they could manage the new diet. A majority of adult patients with ADPKD successfully prepared and followed a composite diet prescription with decreased sodium, protein, acid precursors, and increased fluid intake. This trail was registered at ClinicalTrials.gov (NCT01810614). Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  18. Treatment of Hallux Valgus with Hyaluronic Acid: A Pilot Study

    Directory of Open Access Journals (Sweden)

    Ižlhan Sezer

    2017-05-01