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Sample records for blind comparative study

  1. randomised double blind study to compare effectiveness of honey

    African Journals Online (AJOL)

    2014-02-02

    Feb 2, 2014 ... EAsT AFRICAN MEDICAL JOURNAL. February 2014 .... based randomised double- blinded clinical trial evaluating effectiveness of ... study drugs was undertaken following a random ... included sodium citrate, citric acid monohydrate, ... post-hoc test to carry out pair-wise comparisons of .... self-care market.

  2. Collagenous sprue cross-sectional imaging: a comparative blinded study.

    Science.gov (United States)

    Al-Bawardy, Badr; Sheedy, Shannon P; Herberts, Michelle B; Murray, Joseph A; Rubio-Tapia, Alberto; Rajan, Elizabeth; Bruining, David H; Hansel, Stephanie L; Barlow, John M; Fletcher, Joel G; Fidler, Jeff L

    2017-02-01

    Collagenous sprue (CS) is a rare enteropathy characterized by villous atrophy and a thickened subepithelial collagen band. The aim of this study is to describe the cross-sectional imaging findings of CS. A case-control, retrospective study with cases of all CS patients from January 2000 to 2015 was performed. Inclusion criteria were (1) Histopathologic diagnosis and (2) Imaging with computed tomography abdomen/pelvis (CT A/P), CT enterography (CTE), or magnetic resonance enterography within 6 months of small bowel (SB) biopsy. Control subjects were irritable bowel syndrome (IBS) patients who underwent CTE. Imaging studies were examined by two GI radiologists, blinded to patient data. 108 patients (54 CS; 54 IBS) were included. Mean age was 56.7 ± 16.5 years, and 68% were female (72% in CS group vs. 63% in IBS group; p = 0.3). CS patients were significantly older (67 ± 12 vs. 47 ± 15 year; p reversal (46% vs. 6%; p < 0.001), SB dilation (28% vs. 0%; p < 0.001), SB conformational change (28% vs. 6%; p = 0.002), SB wall thickening (13% vs. 2%; p = 0.03), and ulcerative jejunoileitis (4% vs. 0%; p = 0.01). Radiologists suspected malabsorption in 72% in the CS group and 2% in the IBS group (p < 0.001). Imaging findings suggestive of mucosal malabsorption are commonly demonstrated in CS.

  3. 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.

  4. 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.

  5. A double-blind comparative multicentre study of remoxipride and haloperidol in schizophrenia.

    Science.gov (United States)

    Lindström, L H; Wieselgren, I M; Struwe, G; Kristjansson, E; Akselson, S; Arthur, H; Andersen, T; Lindgren, S; Norman, O; Naimell, L

    1990-01-01

    In a double-blind multicentre study of parallel group design the efficacy and safety of remoxipride and haloperidol were compared in a total of 96 patients with acute episodes of schizophrenic or schizophreniform disorder according to DSM-III. There were 48 patients in each treatment group; 27 men and 21 women in the remoxipride group, 33 men and 15 women in the haloperidol group. The median duration of illness was 7 years in both groups. The mean daily dose was 437 mg for remoxipride and 10.6 mg for haloperidol during the last week of treatment. No statistically significant differences in total BPRS scores were found between remoxipride and haloperidol. The median total BPRS scores at the start of active treatment were 26 in the remoxipride and 27 in the haloperidol group; these were reduced to 16 and 12.5, respectively, at the last rating. According to Clinical Global Impression (CGI), 43% of patients in the remoxipride group and 68% of those in the haloperidol group improved much or very much during treatment. This difference was not statistically significant. Treatment-emergent extrapyramidal side effects such as akathisia, tremor, and rigidity occurred significantly more frequently in the haloperidol group; this group also made more frequent use of anticholinergic drugs. Neither of the trial drugs seriously affected laboratory or cardiovascular variables. It is concluded that remoxipride has an antipsychotic effect in a dose range of 150-600 mg per day comparable to that of haloperidol in doses up to 20 mg per day but with fewer extrapyramidal side effects.

  6. Blind deblurring of spiral CT images - comparative studies on edge-to-noise ratios

    International Nuclear Information System (INIS)

    Jiang Ming; Wan Ge; Skinner, Margaret W.; Rubinstein, Jay T.; Vannier, Michael W.

    2002-01-01

    A recently developed blind deblurring algorithm based on the edge-to-noise ratio has been applied to improve the quality of spiral CT images. Since the discrepancy measure used to quantify the edge and noise effects is not symmetric, there are several ways to formulate the edge-to-noise ratio. This article is to investigate the performance of those ratios with phantom and patient data. In the phantom study, it is shown that all the ratios share similar properties, validating the blind deblurring algorithm. The image fidelity improvement varies from 29% to 33% for different ratios, according to the root mean square error (RMSE) criterion; the optimal iteration number determined for each ratio varies from 25 to 35. Those ratios that are associated with most satisfactory performance are singled out for the image fidelity improvement of about 33% in the numerical simulation. After automatic blind deblurring with the selected ratios, the spatial resolution of CT is substantially refined in all the cases tested

  7. Double blind, randomised study of continuous terbinafine compared with intermittent itraconazole in treatment of toenail onychomycosis

    Science.gov (United States)

    Evans, E Glyn V; Sigurgeirsson, Bárdur

    1999-01-01

    Objective To compare the efficacy and safety of continuous terbinafine with intermittent itraconazole in the treatment of toenail onychomycosis. Design Prospective, randomised, double blind, double dummy, multicentre, parallel group study lasting 72 weeks. Setting 35 centres in six European countries. Subjects 496 patients aged 18 to 75 years with a clinical and mycological diagnosis of dermatophyte onychomycosis of the toenail. Interventions Study patients were randomly divided into four parallel groups to receive either terbinafine 250 mg a day for 12 or 16 weeks (groups T12 and T16) or itraconazole 400 mg a day for 1 week in every 4 weeks for 12 or 16 weeks (groups I3 and I4). Main outcome measures Assessment of primary efficacy at week 72 was mycological cure, defined as negative results on microscopy and culture of samples from the target toenail. Results At week 72 the mycological cure rates were 75.7% (81/107) in the T12 group and 80.8% (80/99) in the T16 group compared with 38.3% (41/107) in the I3 group and 49.1 % (53/108) in the I4 group. All comparisons (T12 v I3, T12 v I4, T16 v I3, T16 v I4) showed significantly higher cure rates in the terbinafine groups (all Pterbinafine at week 72. There were no differences in the number or type of adverse events recorded in the terbinafine or itraconazole groups. Conclusion Continuous terbinafine is significantly more effective than intermittent itraconazole in the treatment of patients with toenail onychomycosis. Key messagesGiven a correct diagnosis, fungal nail disease (onychomycosis) is curableTerbinafine is an allylamine antifungal with a primarily fungicidal mode of actionContinuous terbinafine treatment over 12 or 16 weeks achieves higher rates of clinical and mycological cure than intermittent itraconazole given over the same periodsTerbinafine is safe and well tolerated over 12 or 16 weeks of continuous treatmentContinuous terbinafine should be the current treatment of choice for onychomycosis PMID

  8. [Comparative double-blind study of Bi-Profenid and oxyphenbutazone in sports pathology].

    Science.gov (United States)

    Commandré, F A; Fornaris, E; Fourré, J M; Raybaud, A; Colonna, P; Pirdas, C

    1983-12-12

    Effectiveness and tolerance of ketoprofen in sustained-release tablets (Bi-Profenid 150 mg) were investigated in a double blind trial in 44 athletes who had recently sprained an ankle. Patients were given either 300 mg Bi-Profenid or 400 mg oxyphenbutazone daily for seven days. Treatment regimens were assigned at random. Results were assessed as excellent or good in 85% of patients given Bi-Profenid and 50% of those given oxyphenbutazone. Spontaneous pain resolved in 19 patients receiving Bi-Profenid and in 6 under oxyphenbutazone. Decrease in pain upon physical examination and in articular circumference was significantly greater with Bi-Profenid as compared with oxyphenbutazone. The chance of rapidly resuming sport was better with Bi-Profenid. Tolerance was excellent in 68.2% of patients with Bi-Profenid and 59% of those with oxyphenbutazone. This investigation thus emphasizes the value of Bi-Profenid in sport pathology.

  9. A Comparative Study of the Manneristic Behaviour of Blind and Sighted Children. Research Series No. 1.

    Science.gov (United States)

    Indian National Inst. for the Visually Handicapped, Dehra Dun.

    Examination of the manneristic behavior (stereotyped or repetitive movement) of 542 blind and 365 sighted children was undertaken. Seventeen types of manneristic behavior were investigated, including head movement, eye poking and rubbing, body rocking, kicking, and posture distortion. Comparison of the behaviors observed in sighted and blind Ss…

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

    Science.gov (United States)

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

    2011-06-01

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

  11. Hemodiafiltration Improves Plasma 25-Hepcidin Levels: A Prospective, Randomized, Blinded, Cross-Over Study Comparing Hemodialysis and Hemodiafiltration

    Directory of Open Access Journals (Sweden)

    Bergur V. Stefánsson

    2012-03-01

    Full Text Available Background/Aims: Data from studies comparing the effect of hemodiafiltration (HDF and conventional hemodialysis (HD on clinically important outcomes are insufficient to support superiority of HDF. None of these studies has been participant-blinded. Methods: We performed a prospective, randomized, and patient-blinded cross-over study. Twenty patients on chronic HD received either HD for 2 months followed by post-dilution HDF for 2 months or in opposite order. A range of clinical parameters, as well as markers of inflammation, oxidative stress and iron metabolism was measured. Results: The two treatments were similar with respect to dialysis-related complications, quality of life, and the biomarkers of oxidative stress and inflammation. Compared to HD, 25-hepcidin and β2-microglobulin were 38 and 32%, respectively, lower after 60 days of HDF (p Conclusion: In short term, HDF is not superior to HD regarding dialysis-related complications. The higher ESA consumption observed with HDF can be explained by blood clotting in tubing and dialyzers, as more anticoagulation was needed with post-dilution HDF. In a longer perspective, lowering serum hepcidin levels may improve pathological iron homeostasis.

  12. [Titration comparative study of TOPINA Tablets in patients with localization related epilepsy: double-blind comparative study by rapid and slow titration methods].

    Science.gov (United States)

    Kaneko, Sunao; Inoue, Yushi; Sasagawa, Mutsuo; Kato, Masaaki

    2012-04-01

    To compare the tolerability and efficacy of two titration methods (rapid and slow titration) for TOPINA Tablets with different dosages and periods of escalation, a double-blind comparative study was conducted in patients with localization-related epilepsy. A total of 183 patients were randomized to either rapid titration (initial dosage 100 mg/day increased by 100-200 mg at weekly intervals) or to slow titration (initial dosage 50 mg/day increased in 50 mg/day increments at weekly intervals). TOPINA Tablets were administered for 12 weeks to the maximum dosage of 400 mg/day. The incident of adverse events leading to treatment interruptions or withdrawals was 18.9% in rapid titration and 14.8% in slow titration, with no statistical significance (p = 0.554). The incident of adverse events and adverse reactions of slow titration was slightly lower than that of rapid titration. The common adverse events and adverse reactions reported in the two titration methods were comparable and were well tolerated. On the other hand, the efficacy of slow titration, percent reduction in seizure rate and responder rate, was comparable with that of rapid titration. In conclusion, there were no significant differences of therapeutic response to TOPINA Tablets between the two titration methods.

  13. Ease of intubation: A randomized, double-blind study to compare two doses of rocuronium bromide for endotracheal intubation.

    Science.gov (United States)

    Shukla, Aparna; Misra, Shilpi

    2016-01-01

    Clinical need for a nondepolarizing agent with a rapid onset time and a brief duration of action has led to the development of rocuronium bromide. The aim of this study was to evaluate optimal dose of rocuronium bromide for intubation and to compare the onset time, duration of action, intubating conditions, and hemodynamic effects of two doses of rocuronium bromide. A prospective, randomized, double-blind study. All the patients were divided in a randomized, double-blind fashion into two groups of twenty patients each. Group I patients received rocuronium bromide 0.6 mg/kg intravenously and intubated at 60 s, Group II patients received rocuronium bromide 0.9 mg/kg and intubated at 60 s. The neuromuscular block was assessed using single twitch stimulation of 0.1 Hz at adductor pollicis muscle of hand at every 10 s. The results were compiled and analyzed statistically using Chi-square test for qualitative data and Student's t -test for quantitative data. Time of onset was significantly shorter ( P Rocuronium bromide 0.9 mg/kg is a safer alternative to rocuronium bromide 0.6 mg/kg for endotracheal intubation with shorter time of onset and better intubating conditions.

  14. 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.

  15. Efficiency of levobupivacaine and bupivacaine for supraclavicular block: a randomized double-blind comparative study

    Directory of Open Access Journals (Sweden)

    Cenk Ilham

    2014-06-01

    Full Text Available Background and objectives: Success rate of catheter applications is low in supraclavicular block. Thus, bupivacaine and levobupivacaine become important with their long effect time in single injection practices. In this study, we aimed to compare the effectiveness, side effects and complications of bupivacaine and levobupivacaine in supraclavicular block. Methods: Sixty patients aged between 20 and 65, with body weight between 50 and 100 kg, in the ASA I-II-III group who were scheduled for hand, forearm and arm surgery using supraclavicular block were randomized into two groups of 30. The patients received 30 ml 0.5% bupivacaine (Group B or 30 ml 0.5% levobupivacaine (Group L. Motor and sensory blocks were evaluated. Motor and sensory block onset times, total block durations, postoperative pain, amount of postoperative analgesic used and patient satisfaction were recorded. Results: Demographic data, distribution of surgical area and hemodynamic data were similar between the two groups. Surgery, motor and sensory block durations of Group B and L patients did not vary statistically significantly. However, motor and sensory block onset times in Group B were significantly shorter than Group L (p 0.05. Conclusion: 30 ml 0.5% bupivacaine and levobupivacaine provide similar block characteristics for supraclavicular block. Bupivacaine leads to faster motor and sensory block onset compared to levobupivacaine however similar duration of postoperative analgesia.

  16. A Comparative Study of Simple Auditory Reaction Time in Blind (Congenitally) and Sighted Subjects

    OpenAIRE

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

    2013-01-01

    Background: 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. Objective:...

  17. [Randomized double-blind comparative study of minaprine (200mg/j) and of placebo on memory loss].

    Science.gov (United States)

    Allain, H; Belliard, S; Lieury, A; Menard, G; Patat, A; Le Coz, F; Gandon, J M

    1996-01-01

    Thirty five subjects (age: 45-69 years) with subjective memory loss, without any other neuropsychiatric or somatic disease, were recruited in a phase II study. This double blind randomized versus placebo controlled study compared the effects of minaprine (200 mg/d) with placebo, in two parallel groups, during 2 months, on memory, attention and vigilance. Three psychometric tests were the main criteria of assessment: a standardized battery of memory tests (SM 5), the dual-coding test, the analysis of choice reaction times (CRT) and the critical flicker fusion point (CFF). A positive effect of minaprine was detected on words delayed recall (p = 0.028) and immediate recognition of words (p = 0.049). The global clinical tests (CGI, MacNair scale) were not statistically modified. Tolerability of minaprine and placebo were comparable. A positive pharmacodynamic activity on mnemonic performance is thus demonstrated in favour of minaprine (200 mg/d) in this specific population characterized by a memory complaint. These results would lead to a phase III study in which the main criteria would be global scales in order to confirm the clinical reliability of the present results.

  18. Double blind comparative study of piroxicam and indomethacin in acute locomotor affections linked with sports activity.

    Science.gov (United States)

    Commandre, F

    1983-01-01

    181 patients suffering from acute locomotor affections linked with sports activities were included in a multi-center study. The indications most frequently seen were sprains and tendinitis. 92 patients received piroxicam in a daily dosage of 4 capsules (40 mg) during the first two days, then 20 mg during the following days. 89 patients received a daily dose of indomethacin in a daily dose of 6 capsules (150 mg) for the first two days, and then 100 mg daily thereafter. Treatment lasted from 5 to seven days. Efficacy was judged to be very good or good in 89% of the patients treated with piroxicam against 76% of those treated with indomethacin, a statistically significant difference. Tolerance was also judged better with piroxicam. 4 patients suffered side effects with piroxicam, of which one stopped treatment after the second administration due to allergic reaction. 18 patients treated with indomethacin suffered from side effects, of which 5 stopped the treatment. In total, the use of piroxicam seems particularly interesting in sports medicine in comparison with indomethacin.

  19. Randomized, double-blind, comparative-effectiveness study comparing pulsed radiofrequency to steroid injections for occipital neuralgia or migraine with occipital nerve tenderness.

    Science.gov (United States)

    Cohen, Steven P; Peterlin, B Lee; Fulton, Larry; Neely, Edward T; Kurihara, Connie; Gupta, Anita; Mali, Jimmy; Fu, Diana C; Jacobs, Michael B; Plunkett, Anthony R; Verdun, Aubrey J; Stojanovic, Milan P; Hanling, Steven; Constantinescu, Octav; White, Ronald L; McLean, Brian C; Pasquina, Paul F; Zhao, Zirong

    2015-12-01

    Occipital neuralgia (ON) is characterized by lancinating pain and tenderness overlying the occipital nerves. Both steroid injections and pulsed radiofrequency (PRF) are used to treat ON, but few clinical trials have evaluated efficacy, and no study has compared treatments. We performed a multicenter, randomized, double-blind, comparative-effectiveness study in 81 participants with ON or migraine with occipital nerve tenderness whose aim was to determine which treatment is superior. Forty-two participants were randomized to receive local anesthetic and saline, and three 120 second cycles of PRF per targeted nerve, and 39 were randomized to receive local anesthetic mixed with deposteroid and 3 rounds of sham PRF. Patients, treating physicians, and evaluators were blinded to interventions. The PRF group experienced a greater reduction in the primary outcome measure, average occipital pain at 6 weeks (mean change from baseline -2.743 ± 2.487 vs -1.377 ± 1.970; P occipital pain through 3 months (mean change from baseline -1.925 ± 3.204 vs -0.541 ± 2.644; P = 0.043), and average overall headache pain through 6 weeks (mean change from baseline -2.738 ± 2.753 vs -1.120 ± 2.1; P = 0.037). Adverse events were similar between groups, and few significant differences were noted for nonpain outcomes. We conclude that although PRF can provide greater pain relief for ON and migraine with occipital nerve tenderness than steroid injections, the superior analgesia may not be accompanied by comparable improvement on other outcome measures.

  20. Efficacy and safety of injection with poly-L-lactic acid compared with hyaluronic acid for correction of nasolabial fold: a randomized, evaluator-blinded, comparative study.

    Science.gov (United States)

    Hyun, M Y; Lee, Y; No, Y A; Yoo, K H; Kim, M N; Hong, C K; Chang, S E; Won, C H; Kim, B J

    2015-03-01

    Hyaluronic acid (HA) fillers and poly-L-lactic acid (PLA) fillers are frequently used to correct facial wrinkles. To compare the efficacy and safety of a novel injectable poly-L-lactic acid (PLA) filler and a well-studied biphasic HA filler for the treatment of moderate to severe nasolabial folds. In this multicentre, randomized, evaluator-blinded, comparative study, subjects were randomized for injections with PLA or HA into both nasolabial folds. Efficacy was determined by calculating the change in Wrinkle Severity Rating Scale (WSRS) relative to baseline. Local safety was assessed by reported adverse events. At week 24, mean improvement in WSRS from baseline was 2.09 ± 0.68 for the PLA side and 1.54 ± 0.65 for the HA side. Both injections were well tolerated, and the adverse reactions were mild and transient in most cases. PLA provides noninferior efficacy compared with HA 6 months after being used to treat moderate to severe nasolabial folds. © 2014 British Association of Dermatologists.

  1. Efficacy and Safety of a Mineral Oil-Based Head Lice Shampoo: A Randomized, Controlled, Investigator-Blinded, Comparative Study.

    Science.gov (United States)

    Wolf, Luise; Eertmans, Frank; Wolf, Doerte; Rossel, Bart; Adriaens, Els

    2016-01-01

    Due to increased resistance and safety concerns with insecticide-based pediculicides, there is growing demand for head lice treatments with a physical mode of action. Certain mineral oils kill lice by blocking spiracles or by disrupting the epicuticular wax layer. The present study was performed to evaluate efficacy and safety of a mineral oil-based shampoo. This randomized, controlled, investigator-blinded, monocentric study (EudraCT registration no. 2014-002918-23) was performed from October 2014-June 2015 in Germany. A mineral oil shampoo (Mosquito® Med Läuse Shampoo 10 in Germany, Paranix or Silcap shampoo elsewhere), registered as medical device, was compared to a conventional, locally reimbursed, pyrethroid-based pediculicide (Goldgeist® Forte solution). In total, 107 patients (>1 year) with confirmed head lice infestation were included (test arm: n = 53; control arm: n = 54). All subjects received two applications of either test or control product at day 0 and day 7, according to the instructions for use. Efficacy and safety was evaluated directly, 1h and 24h after first application, before and after second treatment, and at day 10. The main objective was demonstrating a cure rate for the test product, being superior to 70% at day 10. Cure rates at day 10 (corrected for re-infestation) for the test product (96.1%) and control (94%) significantly exceeded the pre-defined target (70%) (p shampoo) can be safe and effective alternatives for insecticide-based pediculicides, with less risk for development of resistance because of the physical mode of action. German Clinical Trials Register (DRKS) DRKS00009753 and EudraCT database 2014-002918-23.

  2. A double-blind study comparing ibuprofen 1800 mg or 2400 mg daily and placebo in sports injuries.

    Science.gov (United States)

    Hutson, M A

    1986-01-01

    In a double-blind, placebo-controlled study of forty-six patients with acute ligamentous damage of the knee, ibuprofen in dosages 1800 mg and 2400 mg produced significant improvements in joint mobility, weight bearing ability and match fitness. Joint effusion, pain on stress and pain severity was significantly improved by all three treatments. Only two patients reported side-effects (one while taking placebo and one taking ibuprofen 2400 mg). The study confirmed the efficacy and excellent tolerance to ibuprofen in patients with sports injuries to the knee.

  3. Efficacy and Safety of a Mineral Oil-Based Head Lice Shampoo: A Randomized, Controlled, Investigator-Blinded, Comparative Study.

    Directory of Open Access Journals (Sweden)

    Luise Wolf

    Full Text Available Due to increased resistance and safety concerns with insecticide-based pediculicides, there is growing demand for head lice treatments with a physical mode of action. Certain mineral oils kill lice by blocking spiracles or by disrupting the epicuticular wax layer. The present study was performed to evaluate efficacy and safety of a mineral oil-based shampoo.This randomized, controlled, investigator-blinded, monocentric study (EudraCT registration no. 2014-002918-23 was performed from October 2014-June 2015 in Germany. A mineral oil shampoo (Mosquito® Med Läuse Shampoo 10 in Germany, Paranix or Silcap shampoo elsewhere, registered as medical device, was compared to a conventional, locally reimbursed, pyrethroid-based pediculicide (Goldgeist® Forte solution. In total, 107 patients (>1 year with confirmed head lice infestation were included (test arm: n = 53; control arm: n = 54. All subjects received two applications of either test or control product at day 0 and day 7, according to the instructions for use. Efficacy and safety was evaluated directly, 1h and 24h after first application, before and after second treatment, and at day 10. The main objective was demonstrating a cure rate for the test product, being superior to 70% at day 10.Cure rates at day 10 (corrected for re-infestation for the test product (96.1% and control (94% significantly exceeded the pre-defined target (70% (p < 0.001, 2-sided, 1-sample, chi-square test with confirmed non-inferiority for the test product. Over all visits, cure rates were consistently higher for the test product, whereas more initially-cured subjects remained lice-free until end of study (78%; control: 60%. Both products were safe and well tolerated, offering good esthetical effects.This study showed that substance-based medical devices (including the tested mineral oil shampoo can be safe and effective alternatives for insecticide-based pediculicides, with less risk for development of resistance because

  4. THERAPEUTIC EQUIVALENCE OF ORIGINAL CLOPIDOGREL (PLAVIX AND ITS GENERIC (EGITROMB. RESULTS OF COMPARATIVE RANDOMIZED CROSS-OVER BLIND STUDY

    Directory of Open Access Journals (Sweden)

    V. V. Yakusevich

    2011-01-01

    Full Text Available Aim. To study therapeutic equivalence (efficacy, safety and tolerability of original clopidogrel (Plavix and its generic (Egitromb in patients of high cardiovascular risk. Material and methods. Thirty one patients with coronary heart disease and indications for clopidogrel therapy were involved into the randomized cross-over blind study. Half of the patients received original clopidogrel (75 mg daily during the first 2 weeks and then they received generic clopidogrel in the same dose during next 2 weeks. Another half of the patients received the drugs in reverse order. Antiplatelet activity of Plavix and Egitromb was estimated by effects on ADP-induced platelet aggregation initially and after 2 weeks of treatment with each drug. Study blinding was provided by the following approach: doctors of cardiology clinic performed clinical monitoring and drug distribution; coded blood samples for platelet aggregation assessment were studied in independent laboratory of thrombosis; statistical data analysis was performed by biostatistics expert in other research center. Results. 2-week therapy with each drug led to a significant decrease of ADP-induced platelet aggregation which remained low after switching from original drug to generic and vice versa. Aggregation dynamics did not depend on the first administered drug. There were no significant differences between aggregation changes as a result of treatment with original or generic drug. No one adverse event was observed in association with both drugs therapy. Conclusion. Generic drug Egitromb (Egis, Hungary and original clopidogrel Plavix (Sanofi-Aventis, France have equivalent antiplatelet effect.

  5. Randomized, Evaluator-Blinded Study Comparing Safety and Effect of Two Hyaluronic Acid Gels for Lips Enhancement.

    Science.gov (United States)

    Hilton, Said; Sattler, Gerhard; Berg, Anna-Karin; Samuelson, Ulf; Wong, Cindy

    2018-02-01

    Hyaluronic acid (HA) fillers may differ in terms of gel characteristics and ease of use and it is of interest whether this might affect safety and duration of effect. To compare the long-term safety and effect of 2 HA fillers produced by 2 different technologies for lip enhancement. Subjects with very thin to moderately thick lips were randomized and treated with HA-RK (N = 31) or HA-JV (N = 29) to improve lip fullness by ≥ 1 grade on a 5-point scale, using a maximum of 3 mL of product. A smaller volume of HA-RK compared with HA-JV was required to improve lip fullness by ≥ 1 grade (mean: 1.54 mL vs 1.94 mL, p < .001). Despite the smaller volume, lip fullness and global aesthetic improvement were comparably sustained in both groups. At 6 months, 60.0% versus 57.7% of subjects (HA-RK vs HA-JV) had improved lip fullness. At 12 months, 71.4% versus 76.0% had aesthetic improvement (blinded evaluations) and 85.7% versus 86.2% felt more attractive. Both products were well tolerated. Both products achieved durable improvement in lip fullness and aesthetic appearance. A significantly smaller amount of HA-RK was required compared with HA-JV to achieve optimal treatment effect.

  6. A Double-Blind, Randomised Study Comparing the Skin Hydration and Acceptability of Two Emollient Products in Atopic Eczema Patients with Dry Skin

    OpenAIRE

    Djokic-Gallagher, Jasmina; Rosher, Phil; Oliveira, Gabriela; Walker, Jennine

    2017-01-01

    Introduction Healthcare professionals tend to recommend emollients based primarily on patient/consumer preference and cost, with cheaper options assumed to be therapeutically equivalent. The aim of this study was therefore to compare the effects on skin hydration of two emollients prescribed in the UK, Doublebase Dayleve? gel (DELP) and a cheaper alternative, Zerobase Emollient? cream (ZBC). Methods This was a single-centre, randomised, double-blind, concurrent bi-lateral (within-patient) com...

  7. Video-based instructions for surgical hand disinfection as a replacement for conventional tuition? A randomised, blind comparative study.

    Science.gov (United States)

    Weber, Uwe; Constantinescu, Mihai A; Woermann, Ulrich; Schmitz, Felix; Schnabel, Kai

    2016-01-01

    Various different learning methods are available for planning tuition regarding the introduction to surgical hand disinfection. These learning methods should help to organise and deal with this topic. The use of a video film is an alternative to conventional tuition due to the real presentation possibilities of practical demonstration. This study examines by way of comparison which form of communication is more effective for learning and applying surgical hand disinfection for medical students in their first year of studies: video-based instruction or conventional tuition. A total of 50 first-year medical students were randomly allocated either to the "Conventional Instruction" (CI) study group or to the "Video-based Instruction" (VI) study group. The conventional instruction was carried out by an experienced nurse preceptor/nurse educator for the operating theatre who taught the preparatory measures and the actual procedure in a two-minute lesson. The second group watched a two-minute video sequence with identical content. Afterwards, both groups demonstrated practically the knowledge they had acquired at an individual practical test station. The quality (a) of the preparation and (b) of the procedure as well as (c) the quality of the results was assessed by 6 blind experts using a check list. The acceptability of the respective teaching method was also asked about using a questionnaire. The group performance did not differ either in the preparation (t=-78, pvideo-based instruction achieved a significantly better result. In response to the question as to which of the two learning methods they would prefer, the significant majority (60.4%) of students stated video instruction. In this study, the use of the video-based instruction emerged as the more effective teaching method for learning surgical hand disinfection for medical students and is preferable to conventional instruction. The video instruction is associated with a higher learning effectiveness, efficiency

  8. Clevidipine compared with nitroglycerin for blood pressure control in coronary artery bypass grafting: a randomized double-blind study.

    Science.gov (United States)

    Merry, Alan F; Avery, Edwin G; Nussmeier, Nancy A; Playford, Hugh R; Warman, Guy R; Wang, Yamei; Sladen, Robert N

    2014-05-01

    We tested the hypothesis that clevidipine, a rapidly acting dihydropyridine calcium channel blocker, is not inferior to nitroglycerin (NTG) in controlling blood pressure before cardiopulmonary bypass (CPB) during coronary artery bypass grafting (CABG). In this double-blind study from October 4, 2003 to April 26, 2004, 100 patients undergoing CABG with CPB were randomized at four centres to receive intravenous infusions of clevidipine (0.2-8 μg·kg(-1)·min(-1)) or NTG (0.4 μg·kg(-1)·min(-1) to a clinician-determined maximum dose rate) from induction of anesthesia through 12 hr postoperatively. The study drug was titrated in the pre-CPB period with the aim of maintaining mean arterial pressure (MAP) within ± 5 mmHg of a clinician-predetermined target. The primary endpoint was the area under the curve (AUC) for the total time each patient's MAP was outside the target range from drug initiation to the start of CPB, normalized per hour (AUCMAP-D). The predefined non-inferiority criterion for the primary endpoint was a 95% confidence interval (CI) upper limit no greater than 1.50 for the geometric means ratio between clevidipine and NTG. Total mean [standard deviation (SD)] dose pre-bypass was 4.5 (4.7) mg for clevidipine and 6.9 (5.4) mg for NTG (P blood pressure control pre-bypass.

  9. Video-based instructions for surgical hand disinfection as a replacement for conventional tuition? A randomised, blind comparative study

    Directory of Open Access Journals (Sweden)

    Weber, Uwe

    2016-08-01

    Full Text Available Introduction: Various different learning methods are available for planning tuition regarding the introduction to surgical hand disinfection. These learning methods should help to organise and deal with this topic. The use of a video film is an alternative to conventional tuition due to the real presentation possibilities of practical demonstration. Objective: This study examines by way of comparison which form of communication is more effective for learning and applying surgical hand disinfection for medical students in their first year of studies: video-based instruction or conventional tuition. Methodology: A total of 50 first-year medical students were randomly allocated either to the “Conventional Instruction” (CI study group or to the “Video-based Instruction” (VI study group. The conventional instruction was carried out by an experienced nurse preceptor/nurse educator for the operating theatre who taught the preparatory measures and the actual procedure in a two-minute lesson. The second group watched a two-minute video sequence with identical content. Afterwards, both groups demonstrated practically the knowledge they had acquired at an individual practical test station. The quality (a of the preparation and (b of the procedure as well as (c the quality of the results was assessed by 6 blind experts using a check list. The acceptability of the respective teaching method was also asked about using a questionnaire.Results: The group performance did not differ either in the preparation (=-78, <0.44 or in the quality (=-99, <0.34. With respect to performance, it was possible to demonstrate a strong treatment effect. In the practical (=-3.33, <0.002, =0.943 and in the total score (=-2.65, <0.011, =0.751, the group with video-based instruction achieved a significantly better result. In response to the question as to which of the two learning methods they would prefer, the significant majority (60.4% of students stated video instruction

  10. Minoxidil 2% lotion for eyebrow enhancement: a randomized, double-blind, placebo-controlled, spilt-face comparative study.

    Science.gov (United States)

    Lee, Saridpong; Tanglertsampan, Chuchai; Tanchotikul, Mingkwan; Worapunpong, Nigun

    2014-02-01

    Topical minoxidil has been successfully used to treat androgenetic alopecia. It can also be applied to enhance eyebrows. However, there is no study comparing minoxidil lotion with placebo for eyebrow enhancement. In this trial, we determined the efficacy and safety of minoxidil 2% lotion for eyebrow enhancement compared with placebo. Forty patients were randomized for minoxidil on the eyebrow on one side of the face and placebo on the other. Efficacy was evaluated by global photographic assessment, eyebrow diameter, eyebrow count and subject's satisfaction. Side-effects were also evaluated. Thirty-nine patients (97.5%) completed the study. After 16 weeks, the minoxidil group achieved significantly better results in all measured outcomes compared to the placebo group. Side-effects were minor and did not preclude patients from continuing the study. Our study suggests that minoxidil 2% lotion is a safe and effective treatment for eyebrow hypotrichosis. © 2014 Japanese Dermatological Association.

  11. RANDOMIZED DOUBLE BLIND STUDY COMPARING ONDANSETRON, PALONOSETRON & GRANISETRON TO PREVENT POST OPERATIVE NAUSEA & VOMITING AFTER LAPAROSCOPIC SURGERIES UNDER GENERAL ANAESTHESIA

    Directory of Open Access Journals (Sweden)

    Rajendra

    2015-11-01

    Full Text Available The aim of the study is to compare the efficacy of intravenously administered 5-HT3 receptor antagonists namely Ondansetron, Palonosetron and Granisetron given as prophylaxis for postoperative nausea and vomiting in patients undergoing laparoscopic surgeries under general anaesthesia. A single dose of palonosetron (0.75 µg when given prophylactically results in a significantly lower incidence of PONV after laparoscopic surgeries than ondansetron (4mg and granisetron (2.5mg during the first 24 hours

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

    OpenAIRE

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

    2012-01-01

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

  13. Aggregated data from two double-blind base station provocation studies comparing individuals with idiopathic environmental intolerance with attribution to electromagnetic fields and controls.

    Science.gov (United States)

    Eltiti, Stacy; Wallace, Denise; Russo, Riccardo; Fox, Elaine

    2015-02-01

    Data from two previous studies were aggregated to provide a statistically powerful test of whether exposure to electromagnetic fields (EMFs) produced by telecommunication base stations negatively affects well-being in individuals who report idiopathic environmental illness with attribution to electromagnetic fields (IEI-EMF) and control participants. A total of 102 IEI-EMF and 237 controls participated in open provocation trials and 88 IEI-EMF and 231 controls went on to complete double-blind trials in which they were exposed to EMFs from a base station emitting either a Global System for Mobile Communication and Universal Mobile Telecommunications System or a Terrestrial Trunked Radio Telecommunications System signal. Both experiments included a comparison sham condition. Visual analog and symptom scales measured subjective well-being. Results showed that IEI-EMF participants reported lower levels of well-being during real compared to sham exposure during open provocation, but not during double-blind trials. Additionally, participants reported lower levels of well-being during high compared to low load trials and this did not interact with radiofrequency-EMF exposure. These findings are consistent with a growing body of literature indicating there is no causal relationship between short-term exposure to EMFs and subjective well-being in members of the public whether or not they report perceived sensitivity to EMFs. © 2015 Wiley Periodicals, Inc.

  14. Evaluation of intralesional injection of hyaluronic acid compared with verapamil in Peyronie's disease: preliminary results from a prospective, double-blinded, randomized study.

    Science.gov (United States)

    Favilla, V; Russo, G I; Zucchi, A; Siracusa, G; Privitera, S; Cimino, S; Madonia, M; Cai, T; Cavallini, G; Liguori, G; D'Achille, G; Silvani, M; Franco, G; Verze, P; Palmieri, A; Torrisi, B; Mirone, V; Morgia, G

    2017-07-01

    Several intralesional therapeutic protocols have been proposed for the treatment of Peyronie's disease. Among all, hyaluronic acid (HA) and verapamil have been differently tested. We aimed to evaluate the efficacy of intralesional verapamil (ILVI) compared with intralesional HA in patients with early onset of Peyronie's disease (PD). This is a multi-centre prospective double-arm, randomized, double-blinded study comparing ILVI vs. intralesional HA after 12-weeks. Sexually active men, older than 18 years and affected by the acute phase of PD were eligible for this study. Patients have been double-blinded randomly divided into two groups (1 : 1 ratio): Group A received intralesional treatment with Verapamil (10 mg in 5 mL of normal saline water) weekly for 12 weeks, while group B received intralesional treatment with HA (0.8% highly purified sodium salt HA 16 mg/2 mL) weekly for 12 weeks. The primary efficacy outcome was the change from the baseline to the endpoint (12 weeks after therapy) for the penile curvature (degree). The secondary outcome was the change in the plaque size and in the International Index of erectile Function (IIEF-5) score. The difference between post- and pre-treatment plaque size was -1.36 mm (SD ± 1.27) for Group A and -1.80 mm (SD ± 2.47) for Group B (p-value = NS). IIEF-5 increased of 1.46 points (SD ± 2.18) in Group A and 1.78 (SD ± 2.48) in Group B (p-value ± NS). No difference in penile curvature was observed in Group A, while in Group B the penile curvature decreased of 4.60° (SD ± 5.63) from the baseline (p < 0.001) and vs. Group A. According to PGI-I results, we found significant difference as concerning patient global impression of improvement (PGI-I) (4.0 vs. 2.0; p < 0.05). This prospective, double-arm, randomized, double-blinded study comparing ILVI vs. HA as intralesional therapy showed greater efficacy of HA in terms of penile curvature and PGI-I. © 2017 American Society of Andrology and

  15. A blinded prospective study comparing four current noninvasive approaches in the differential diagnosis of medical versus surgical jaundice

    International Nuclear Information System (INIS)

    O'Connor, K.W.; Snodgrass, P.J.; Swonder, J.E.; Mahoney, S.; Burt, R.; Cockerill, E.M.; Lumeng, L.

    1983-01-01

    A prospective study was undertaken to compare the diagnostic accuracy of clinical evaluation, ultrasound, computed tomography, and technetium 99m-HIDA or -PIPIDA biliary scans in distinguishing between intrahepatic and extrahepatic jaundice. A final diagnosis was established in each of the 50 patients who completed the study, among whom 29 had intrahepatic cholestasis and 21 had extrahepatic obstruction. In the diagnosis of extrahepatic obstruction, the sensitivities of clinical evaluation, ultrasound, computed tomography, and nuclear medicine biliary scan were 95%, 55%, 63%, and 41%, respectively; the specificities were 76%, 93%, 93%, and 88%; and the overall accuracies were 84%, 78%, 81%, and 68%. These data support the conclusion that when the clinical evaluation is carefully performed, it is the single most effective noninvasive means of detecting extrahepatic biliary obstruction in a jaundiced patient. Although ultrasound, computed tomography, and radionuclide biliary scan are less sensitive, they are highly reliable if they indicate that extrahepatic obstruction is present. A flow chart of invasive and noninvasive approaches for evaluation of the jaundiced patient is presented

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

    Science.gov (United States)

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

    2013-02-01

    The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety. We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the 133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60) were available for follow-up 1 year postsurgery. No significant differences were found between groups regarding demographics or incontinence grade. One year after surgery, both subjective and objective cure rates were significantly lower for TVT Secur than for TVT (subjective cure: TVT 98 %, TVT Secur 80 %, p = 0.03; objective cure: TVT 94 %, TVT Secur 71 % for cough test, p = 0.01; TVT 76 %, TVT Secur 58 % for pad test, p = 0.05 ). Three major complications occurred in the TVT Secur group: one tape erosion into the urethra, one tape inadvertently placed into the bladder, and one immediate postoperative bleeding due to injury to the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding peroperative bleeding, hospital stay, urge symptoms, residual urinary volume, subjective bladder emptying problems, postoperative urinary tract infections, and minor complications. The TVT Secur group used more antimuscarine medication after surgery than the TVT group (p = 0.03). Median time for surgery was 13 and 22 min for TVT Secur and TVT, respectively (p TVT Secur procedure had significantly inferior subjective and objective cure rates compared with the retropubic TVT procedure. Three serious adverse events occurred in the TVT Secur group. We therefore discourage further use of TVT Secur.

  17. Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur.

    Science.gov (United States)

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

    2011-07-01

    The aim of this prospective randomized multicenter study was to compare TVT (tension-free vaginal tape) with TVT-Secur in terms of efficacy and safety. We set out to enrol 280 stress incontinent women with a half time interim analysis of short-term cure and a continuous registration of adverse events. Of 133 randomized women, 126 were operated and 123 (TVT n = 62, TVT-Secur n = 61) available for 2 months follow-up. No significant differences were found between groups regarding demographics or grade of incontinence. At 2 months follow-up, subjective cure rate following TVT-Secur was significantly lower than for TVT (72% and 92%, respectively, p = 0.01). Three major complications occurred in the TVT-Secur group: tape erosion into the urethra, a tape inadvertently placed inside the bladder, and an immediate postoperative bleeding from the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding perioperative bleeding, hospital stay, urge symptoms, or postoperative urinary tract infections. Median time for surgery was 13 and 22 min for TVT-Secur and TVT, respectively (p TVT-Secur procedure had a significantly lower subjective cure rate than the retropubic TVT procedure. Due to this, in addition to three serious complications in the TVT-Secur group, we decided to stop further enrolment after the interim analysis. We discourage from further use of the TVT-Secur.

  18. Lymphoid irradiation in intractable rheumatoid arthritis. A double-blind, randomized study comparing 750-rad treatment with 2,000-rad treatment

    International Nuclear Information System (INIS)

    Hanly, J.G.; Hassan, J.; Moriarty, M.; Barry, C.; Molony, J.; Casey, E.; Whelan, A.; Feighery, C.; Bresnihan, B.

    1986-01-01

    Twenty patients with intractable rheumatoid arthritis were treated with 750-rad or 2,000-rad lymphoid irradiation in a randomized double-blind comparative study. Over a 12-month followup period, there was a significant improvement in 4 of 7 and 6 of 7 standard parameters of disease activity following treatment with 750 rads and 2,000 rads, respectively. Transient, short-term toxicity was less frequent with the lower dose. In both groups, there was a sustained peripheral blood lymphopenia, a selective depletion of T helper (Leu-3a+) lymphocytes, and reduced in vitro mitogen responses. These changes did not occur, however, in synovial fluid. These results suggest that 750-rad lymphoid irradiation is as effective as, but less toxic than, that with 2,000 rads in the management of patients with intractable rheumatoid arthritis

  19. Evaluation of chemical and/or mechanical treatments of the smear layer as revealed by scanning electron microscopy - a blind comparative study

    Directory of Open Access Journals (Sweden)

    LUZ Maria Aparecida Alves de Cerqueira

    2000-01-01

    Full Text Available A blind comparative study of chemical and/or mechanical treatments of the smear layer, according to scanning electron microscopy images, was carried out. The effect of the treatments was analyzed on the smear layer of mesio-occlusodistal cavity walls prepared in vitro in human third molars. The agents used were air/water spray, 37% phosphoric acid, 5% tannic acid, biologic detergent, 0.5% sodium hypochlorite, and enamel hatchet alone or in association with the previous agents. Electron micrographs were evaluated by three professionals according to the degree of visualization of underlying dentin or enamel. Phosphoric acid received the highest scores due to the complete removal of the smear layer. However, statistical analyses revealed diverse performances of non or slightly demineralizing agents, according to the cavity walls in dentin, while there was equivalent effect on the enamel of gingival walls.

  20. Causes of Severe Visual Impairment and Blindness: Comparative Data From Bhutanese and Laotian Schools for the Blind.

    Science.gov (United States)

    Farmer, Lachlan David Mailey; Ng, Soo Khai; Rudkin, Adam; Craig, Jamie; Wangmo, Dechen; Tsang, Hughie; Southisombath, Khamphoua; Griffiths, Andrew; Muecke, James

    2015-01-01

    To determine and compare the major causes of childhood blindness and severe visual impairment in Bhutan and Laos. Independent cross-sectional surveys. This survey consists of 2 cross-sectional observational studies. The Bhutanese component was undertaken at the National Institute for Vision Impairment, the only dedicated school for the blind in Bhutan. The Laotian study was conducted at the National Ophthalmology Centre and Vientiane School for the Blind. Children younger than age 16 were invited to participate. A detailed history and examination were performed consistent with the World Health Organization Prevention of Blindness Eye Examination Record. Of the 53 children examined in both studies, 30 were from Bhutan and 23 were from Laos. Forty percent of Bhutanese and 87.1% of Laotian children assessed were blind, with 26.7% and 4.3%, respectively, being severely visually impaired. Congenital causes of blindness were the most common, representing 45% and 43.5% of the Bhutanese and Laotian children, respectively. Anatomically, the primary site of blinding pathology differed between the cohorts. In Bhutan, the lens comprised 25%, with whole globe at 20% and retina at 15%, but in Laos, whole globe and cornea equally contributed at 30.4%, followed by retina at 17.4%. There was an observable difference in the rates of blindness/severe visual impairment due to measles, with no cases observed in the Bhutanese children but 20.7% of the total pathologies in the Laotian children attributable to congenital measles infection. Consistent with other studies, there is a high rate of blinding disease, which may be prevented, treated, or ameliorated.

  1. Who should be performing routine abdominal ultrasound? A prospective double-blind study comparing the accuracy of radiologist and radiographer

    International Nuclear Information System (INIS)

    Leslie, A.; Lockyer, H.; Virjee, J.P.

    2000-01-01

    AIM: To compare the accuracy of radiographers and radiologists in routine abdominal ultrasound. MATERIALS AND METHODS: One hundred consecutive patients attending for routine abdominal ultrasound were included. Each patient was examined by both a radiographer and radiologist. Both operators noted their findings and wrote a concluding report without conferring. Reports were compared. Where there was disagreement the patient was either re-examined by another radiologist or had further investigation. RESULTS: Of 100 patients, 52 were men and 48 were women. The age range was 19-88 years (median 52 years). Thirty-seven patients had renal tract ultrasound, one had an aortic ultrasound and 62 had general upper abdominal ultrasound. In 44 cases both operators reported the examination as normal. In 49 cases both operators reported the examinations as abnormal and there was complete agreement between the operators. In seven cases there was not complete agreement between operators. Three of these disagreements were considered minor and four major. In three of the seven cases the radiographer was correct, and in four the radiologist was correct. CONCLUSION: Experienced radiographers and radiologists are highly accurate in performing and interpreting routine abdominal sonography. Both operators missed a small minority of abnormalities. There was no statistically significant difference in the accuracy of radiographers and radiologist. Leslie, A. (2000)

  2. Double-blind comparative study of droperidol, granisetron and granisetron plus dexamethasone as prophylactic anti-emetic therapy in patients undergoing abdominal, gynaecological, breast or otolaryngological surgery

    NARCIS (Netherlands)

    Janknegt, R; Pinckaers, JWM; Rohof, MHC; Ausems, MEM; Arbouw, MEL; van der Velden, RW; Brouwers, JRBJ

    In this double-blind study the clinical efficacy of a single pre-operative intravenous dose of droperidol 1.25 mg (137 patients), granisetron 1 mg (130 patients) and granisetron 1 mg plus dexamethasone 5 mg (130 patients) was investigated for the prevention of postoperative nausea and vomiting after

  3. Randomized, double-blind, controlled, comparative trial of formula food containing soy protein vs. milk protein in visceral fat obesity. FLAVO study

    International Nuclear Information System (INIS)

    Takahira, Masaya; Noda, Keita; Fukushima, Mikio; Zhang, Bo; Mitsutake, Ryoko; Uehara, Yoshinari; Ogawa, Masahiro; Saku, Keijiro; Kakuma, Tatsuyuki

    2011-01-01

    The purpose of the present study was to clarify the efficacy of soy at reducing visceral fat. A randomized, double-blind, controlled, comparative trial was carried out to compare formula food containing soy protein (SP) to the same food in which soy was replaced with milk protein (MP). Forty-eight participants were enrolled for the treatment of visceral fat obesity (visceral fat area >100 cm 2 on computed tomography). The SP formula contained 12 g of SP, 9 g of MP, and other nutrients, and was given for 20 weeks in the morning, while in the MP formula SP was replaced with MP. During the 20 weeks of the trial period, visceral fat area and subcutaneous fat area in the MP group were significantly reduced, while those in the SP group did not change as assessed on analysis of covariance. Although waist circumference was reduced in both the SP and MP groups, body weight and body mass index were significantly reduced only in the MP group. Based on a mixed-effects model, the difference in log-transformed visceral fat profiles between the 2 groups was statistically significant (P<0.05), while a negative relationship was observed between the changes in visceral fat and adiponectin in the MP group (P<0.001), but not in the SP group. Formula food containing MP is superior to that containing SP for reducing visceral and subcutaneous fat. (author)

  4. Comparing Whole Building Energy Implications of Sidelighting Systems with Alternate Manual Blind Control Algorithms

    Directory of Open Access Journals (Sweden)

    Christopher Dyke

    2015-05-01

    Full Text Available Currently, there is no manual blind control guideline used consistently throughout the energy modeling community. This paper identifies and compares five manual blind control algorithms with unique control patterns and reports blind occlusion, rate of change data, and annual building energy consumption. The blind control schemes detailed here represent five reasonable candidates for use in lighting and energy simulation based on difference driving factors. This study was performed on a medium-sized office building using EnergyPlus with the internal daylight harvesting engine. Results show that applying manual blind control algorithms affects the total annual consumption of the building by as much as 12.5% and 11.5% for interior and exterior blinds respectively, compared to the Always Retracted blinds algorithm. Peak demand was also compared showing blind algorithms affected zone load sizing by as much as 9.8%. The alternate algorithms were tested for their impact on American Society of Heating, Refrigeration and Air-Conditioning Engineers (ASHRAE Guideline 14 calibration metrics and all models were found to differ from the original calibrated baseline by more than the recommended ±15% for coefficient of variance of the mean square error (CVRMSE and ±5% for normalized mean bias error (NMBE. The paper recommends that energy modelers use one or more manual blind control algorithms during design stages when making decisions about energy efficiency and other design alternatives.

  5. A double-blind, randomized, comparative study to evaluate the efficacy and safety of zaleplon versus zolpidem in shortening sleep latency in primary insomnia.

    Science.gov (United States)

    Huang, Yu-Shu; Hsu, Shih-Chieh; Liu, Shen-Ing; Chen, Chih-Ken

    2011-01-01

    Benzodiazepines cause a high proportion of adverse effects while non-benzodiazepine compounds have demonstrated high efficacy and less adverse effects in patients with insomnia. The objective of this study was to compare the effectiveness and safety of non-BZ zaleplon and zolpidem in primary insomnia. This was a randomized, double-blind, active-controlled, double-dummy, comparative study. A total of 48 patients were enrolled, of which 45 patients completed the study. Patients who entered the study were required to take the study drug orally once daily at bedtime for two weeks. Each patient kept a sleep diary and answered a questionnaire. We used these documents to measure and evaluate changes from baseline to Week 2 in sleep latency, duration and quality of sleep, the number of awakenings and incidence of rebound insomnia. The data revealed a significant decrease in sleep latency from baseline to Week 2 for patients receiving zaleplon 10 mg and zolpidem 10 mg. Patients receiving zaleplon exhibited a marginally greater, but not statistically significant, reduction in sleep latency than those who received zolpidem. There was no significant difference in the frequency of adverse effects between the zaleplon and zolpidem groups; however, during this clinical trial there was one lethal event caused by a traffic accident in the zaleplon group. There was no significant difference between zaleplon and zolpidem in the efficacy of reducing sleep latency or adverse effects. A large pharmacovigilance study is needed before concluding that either zolpidem or zaleplon is free from next-day residual effects.

  6. Aural stimulation with capsaicin ointment improved swallowing function in elderly patients with dysphagia: a randomized, placebo-controlled, double-blind, comparative study.

    Science.gov (United States)

    Kondo, Eiji; Jinnouchi, Osamu; Nakano, Seiichi; Ohnishi, Hiroki; Kawata, Ikuji; Okamoto, Hidehiko; Takeda, Noriaki

    2017-01-01

    The aim of this study was to assess whether aural stimulation with ointment containing capsaicin improves swallowing function in elderly patients with dysphagia. A randomized, placebo-controlled, double-blind, comparative study. Secondary hospital. Twenty elderly dysphagic patients with a history of cerebrovascular disorder or Parkinson's disease were randomly divided into two groups: 10 receiving aural stimulation with 0.025% capsaicin ointment and 10 stimulated with placebo. The ointments were applied to the external auditory canal with a cotton swab. Then, swallowing of a bolus of blue-dyed water was recorded using transnasal videoendoscopy, and the swallowing function was evaluated according to both endoscopic swallowing scoring and Sensory-Motor-Reflex-Clearance (SMRC) scale. The sum of endoscopic swallowing scores was significantly decreased 30 and 60 min after a single administration in patients treated with capsaicin, but not with placebo. Reflex score, but not Sensory, Motion and Clearance scores, of the SMRC scale was significantly increased 5, 30 and 60 min after single administration in patients treated with capsaicin, but not with placebo. No patient showed signs of adverse effects. As capsaicin is an agonist of the transient receptor potential vanilloid 1 (TRPV1), these findings suggest that improvement of the swallowing function, especially glottal closure and cough reflexes, in elderly dysphagic patients was due to TRPV1-mediated aural stimulation of vagal Arnold's nerve with capsaicin, but not with a nonspecific mechanical stimulation with a cotton swab.

  7. Randomised, double-blind, comparative study to evaluate the efficacy and safety of ganaton (itopride hydrochloride) and mosapride citrate in the management of functional dyspepsia.

    Science.gov (United States)

    Amarapurkar, Deepak N; Rane, Priya

    2004-12-01

    Prokinetic agents like itopride hydrochloride and mosapride citrate are commonly used in the management of functional dyspepsia. However, in a recently conducted international, multicentric study, efficacy of 3 different regimens of mosapride was shown to be comparable to placebo. The objective of this phase 4 randomised, double blind, prospective study was to compare the efficacy and safety of ganaton (itopride hydrochloride) and mosapride citrate in the management of functional dyspepsia among patients attending the gastroenterology outpatient department of a tertiary care hospital. Ganaton 50 mg or mosapride citrate 5 mg three times daily before meals for a period of 2 weeks was administered orally. Thirty functional dyspepsia patients in each group (total = 60) were randomised to receive itopride hydrochloride or mosapride citrate treatment for 2 weeks. In itopride versus mosapride groups, global efficacy as judged by patients was excellent in 17 versus 9 (p itopride versus mosapride group global efficacy as judged by physician was excellent in 24 (80%) versus 15 (50%) and poor in 0 (0%) versus 3 (10%) patients respectively. The global efficacy was rated as excellent to good in significantly (p itopride (93.3%) group as compared to mosapride (63.33 %) group. None of the patients reported any adverse events with itopride treatment. In the mosapride group 5 patients (16.7%) reported adverse events. Two patients (6.7%) were withdrawn from mosapride treatment due to adverse events. The physician rated global tolerability ofitopride versus mosapride treatment as excellent in 23 (76.7%) versus 8 (26.7%) (p itopride hydrochloride) is superior in efficacy and safety over mosapride citrate in the management of functional dyspepsia.

  8. Insight and Treatment Outcomes in Schizophrenia: Post-hoc Analysis of a Long-term, Double-blind Study Comparing Lurasidone and Quetiapine XR.

    Science.gov (United States)

    Harvey, Philip D; Siu, Cynthia O; Loebel, Antony D

    2017-12-01

    Objective: The objective of this post-hoc analysis was to evaluate the effect of lurasidone and quetiapine extended-release (XR) on insight and judgment and assess the longitudinal relationships between improvement in insight and cognitive performance, functional capacity, quality of well-being, and depressive symptoms in patients with schizophrenia. Design: Clinically unstable patients with schizophrenia (N=488) were randomized to once-daily, fixed-dose treatment with lurasidone 80mg, lurasidone 160mg, quetiapine XR 600mg, or placebo, followed by a long-term, double-blind, flexible-dose continuation study involving these agents. Results: Significantly greater improvement in insight and judgment (assessed by the Positive and Negative Syndrome Scale G12 item) for the lurasidone and quetiapine XR groups, compared to the placebo group, was observed at Week 6. Over a subsequent six-month continuation period, the flexible dose lurasidone group showed significantly greater improvement in insight from acute phase baseline compared to the flexible-dose quetiapine XR group (QXR-QXR) (p=0.032). Improvement in insight was significantly correlated with improvement in cognition ( p =0.014), functional capacity (p=0.006, UPSA-B), quality of well-being ( p =0.033, QWB), and depressive symptoms ( p =0.05, Montgomery-Åsberg Depression Rating Scale [MADRS] score) across treatment groups and study periods. Conclusion: In this post-hoc analysis, flexibly dosed lurasidone 40 to 160mg/d was found to be associated with significantly greater improvement in insight compared to flexibly dosed quetiapine XR 200 to 800mg/d over long-term treatment in patients with schizophrenia. Across treatment groups, improvement in insight and judgment was significantly associated with improvement in cognition, functional capacity, quality of well-being, and depressive symptoms over time.

  9. Efficacy, tolerability and consumer acceptability of terbinafine topical spray versus terbinafine topical solution: a phase IIa, randomised, observer-blind, comparative study.

    Science.gov (United States)

    Brown, Marc; Evans, Charles; Muddle, Andrew; Turner, Rob; Lim, Sian; Reed, Jessica; Traynor, Matt

    2013-10-01

    Tinea pedis is one of the world's most prevalent dermatophyte infections. MedSpray™ tinea pedis 1 % w/w (topical spray) is a novel, easy-to-use propellant-based spray formulation containing 1 % w/w terbinafine, requiring no manipulation at the site of infection. This is in contrast to the only formulation currently approved in Europe for single application (none are approved in the USA for single use), which is Lamisil(®) Once 1 % w/w (topical solution), containing 1 % w/w terbinafine hydrochloride, which requires manipulation on the affected area. The aim of this study was to evaluate the efficacy, tolerability and consumer acceptability of a topical spray versus a topical solution in the treatment of tinea pedis. This study is a phase IIa, randomised, observer-blind, non-inferiority comparative study of the topical spray compared with the topical solution over a 12-week study period. The study was conducted at Bioskin GmbH, Hamburg and Berlin. Patients (n = 120) who presented with the presence of interdigital tinea pedis caused by dermatophytes on one or both feet were enrolled in the study. Patients were randomly assigned between the two treatment groups. Either the topical spray or the topical solution was administered by the study nurse and consisted of a single application (equivalent to 20 mg of terbinafine per foot) on day 1 of the study. No further applications were made for the duration of the study. The hypothesis formulated before commencement of the study was that the topical spray would prove to be non-inferior to the topical solution. Efficacy assessments, including clinical signs and symptoms, mycology and microscopy were performed at baseline and 1, 6 and 12 weeks after treatment. The rate of mycological cure at week 1 was statistically equivalent for both treatments. There was a significant reduction in the overall clinical score as assessed by the Physician's Global Assessment of signs and symptoms for both treatment groups. The topical

  10. Efficacy of DA-9701 (Motilitone) in Functional Dyspepsia Compared to Pantoprazole: A Multicenter, Randomized, Double-blind, Non-inferiority Study.

    Science.gov (United States)

    Jung, Hye-Kyung; Lee, Kwang Jae; Choi, Myung-Gyu; Park, Hyojin; Lee, Joon Seong; Rhee, Poong-Lyul; Kim, Nayoung; Park, KyungSik; Choi, Suck Chei; Lee, Oh Young; Huh, Kyu Chan; Song, Geun Am; Hong, Su Jin; Sohn, Chong Il; Jung, Hwoon-Yong; Lee, Yong Chan; Rew, Jong Sun; Jee, Sam Ryong; Kwon, Joong Goo

    2016-04-30

    The effect of proton pump inhibitors (PPI) in Asian functional dyspepsia (FD) patients has not been well established as in Westerncountries. DA-9701, a novel prokinetic agent, stimulates gastric emptying and modulates visceral hypersensitivity in vivo and in human studies. This study was conducted to compare the efficacy of DA-9701 with a conventional PPI in mono or combination therapy in patients with FD. In this double-blind, randomized, non-inferiority trial, 389 patients diagnosed with FD using Rome III criteria were allocated among3 groups: 30-mg DA-9701 t.i.d (means 3 times a day), 40-mg pantoprazole, and 30-mg DA-9701 t.i.d + 40-mg pantoprazole. Theprimary efficacy end-point was a global assessment of the patient binary response or response on a 5-Likert scale after 4 weeks. The global symptomatic improvement was 60.5% in the DA-9701 group, 65.6% in the pantoprazole group, and 63.5% in the DA-9701 + pantoprazole group using a 5-Likert scale at week 4 with no significant difference among 3 groups (P = 0.685). Symptomimprovement measured by binary outcome was significantly achieved in each of the 3 groups, but not different among groups.Patients in all treatment groups reported significant improvement in the response rate and symptoms according to FD subtypes anddyspepsia-related quality of life (P DA-9701 improves global and individual symptoms and increases dyspepsia-specific quality of life in patients with FD. The efficacyof DA-9701 monotherapy is comparable with pantoprazole and there is no additive effect with combination of DA-9701 andpantoprazole in patients with FD.

  11. A prospective, comparative, evaluator-blind clinical study investigating efficacy and safety of two injection techniques with Radiesse ® for the correction of skin changes in aging hands

    Directory of Open Access Journals (Sweden)

    Elena I Gubanova

    2015-01-01

    Full Text Available Background: Dermal fillers are used to correct age-related changes in hands. Aims: Assess efficacy and safety of two injection techniques to treat age-related changes in the hands using calcium hydroxylapatite filler, Radiesse ® . Settings and Design: This was a prospective, comparative, evaluator-blind, single-center study. Materials and Methods: Radiesse ® (0.8 mL/0.2 mL 2% lidocaine was injected subdermally on Day (D01, using a needle multipoint technique in one hand (N and a fan-like cannula technique in the other (C. Assessments were made pre-injection, on D14, Month (M02, M03 and M05 using the Merz Aesthetics Hand Grading Scale (MAS and Global Aesthetic Improvement Scale (GAIS. Participants completed questionnaires on satisfaction, pain and adverse events (AEs. Statistical Analysis Used: Data distribution was tested with the Shapiro-Wilk and Levene′s tests. The Wilcoxon signed-rank and Chi-square tests were employed to evaluate quantitative and qualitative data, respectively. Results: All 10 participants completed the study, four opted for a M03 touch-up (0.8 mL Radiesse ® . Evaluator-assessed mean GAIS scores were between 2 (significant improvement but not complete correction and 3 (optimal cosmetic result at each time point. The MAS score improved from D01 to M05 (N: 2.60 to 1.40; C: 2.20 to 1.30. Following treatment, participants reported skin was softer, more elastic, more youthful and less wrinkled. Other than less noticeable veins and tendons on the C hand, no differences in participant satisfaction were noted. All AEs were mild, with no serious AEs reported. Conclusions: Both injection techniques (needle and cannula demonstrated equivalent clinical efficacy with a comparable safety profile for the correction of age-related changes in hands with Radiesse ® .

  12. A Double-Blind, Randomised Study Comparing the Skin Hydration and Acceptability of Two Emollient Products in Atopic Eczema Patients with Dry Skin.

    Science.gov (United States)

    Djokic-Gallagher, Jasmina; Rosher, Phil; Oliveira, Gabriela; Walker, Jennine

    2017-09-01

    Healthcare professionals tend to recommend emollients based primarily on patient/consumer preference and cost, with cheaper options assumed to be therapeutically equivalent. The aim of this study was therefore to compare the effects on skin hydration of two emollients prescribed in the UK, Doublebase Dayleve™ gel (DELP) and a cheaper alternative, Zerobase Emollient™ cream (ZBC). This was a single-centre, randomised, double-blind, concurrent bi-lateral (within-patient) comparison in 18 females with atopic eczema and dry skin on their lower legs. DELP gel and ZBC cream were each applied to one lower leg twice daily for 4 days and on the morning only on day 5. The efficacy of both products was assessed by hydration measurements using a Corneometer CM825 probe (Courage-Khazaka Electronic). The measurements were made three times daily on days 1 to 5. The primary efficacy variable was the area under the curve (AUC) of the change from baseline corneometer readings over the 5 days. Skin hydration using DELP gel was significantly higher than using ZBC cream (p skin hydration observed for DELP gel was substantial and long lasting. In contrast, for ZBC cream, there was no significant improvement of the cumulative skin hydration as measured by the AUC (p = 0.22). DELP gel achieved substantial, long-lasting and cumulative skin hydration, whilst ZBC cream achieved no measurable improvement in skin hydration compared to before treatment. Healthcare professionals should be aware that different emollients can perform differently. Dermal Laboratories Ltd. EudraCT number:2014-001026-16.

  13. A Randomized Single Blind Parallel Group Study Comparing Monoherbal Formulation Containing Holarrhena antidysenterica Extract with Mesalamine in Chronic Ulcerative Colitis Patients

    Directory of Open Access Journals (Sweden)

    Sarika Johari

    2016-01-01

    Full Text Available Background: Incidences of side effects and relapses are very common in chronic ulcerative colitis patients after termination of the treatment. Aims and Objectives: This study aims to compare the treatment with monoherbal formulation of Holarrhena antidysenterica with Mesalamine in chronic ulcerative colitis patients with special emphasis to side effects and relapse. Settings and Design: Patients were enrolled from an Ayurveda Hospital and a private Hospital, Gujarat. The study was randomized, parallel group and single blind design. Materials and Methods: The protocol was approved by Institutional Human Research Ethics Committee of Anand Pharmacy College on 23rd Jan 2013. Three groups (n = 10 were treated with drug Mesalamine (Group I, monoherbal tablet (Group II and combination of both (Group III respectively. Baseline characteristics, factors affecting quality of life, chronicity of disease, signs and symptoms, body weight and laboratory investigations were recorded. Side effects and complications developed, if any were recorded during and after the study. Statistical Analysis Used: Results were expressed as mean ± SEM. Data was statistically evaluated using t-test, Wilcoxon test, Mann Whitney U test, Kruskal Wallis test and ANOVA, wherever applicable, using GraphPad Prism 6. Results: All the groups responded positively to the treatments. All the patients were positive for occult blood in stool which reversed significantly after treatment along with rise in hemoglobin. Patients treated with herbal tablets alone showed maximal reduction in abdominal pain, diarrhea, and bowel frequency and stool consistency scores than Mesalamine treated patients. Treatment with herbal tablet alone and in combination with Mesalamine significantly reduced the stool infection. Patients treated with herbal drug alone and in combination did not report any side effects, relapse or complications while 50% patients treated with Mesalamine exhibited the relapse with

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

    Science.gov (United States)

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

    2013-06-01

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

  15. Intrathecal isobaric ropivacaine-fentanyl versus intrathecal isobaric bupivacaine-fentanyl for labor analgesia: A controlled comparative double-blinded study

    Directory of Open Access Journals (Sweden)

    Meenoti Pramod Potdar

    2014-01-01

    Full Text Available Context: Neuraxial analgesia and walking epidural is the popular method of practicing labor analgesia. The combination of local anesthetic and opioid is advantageous as it prolongs the duration of labor analgesia. Ropivacaine is the newer local anesthetic agent having lesser motor effects and toxic effects hence would be preferred for labor analgesia. Aims: The primary objective of the study was to assess the duration of analgesia of the intrathecal drug. The secondary objective was the assessment of onset, fixation of analgesia, motor weakness, ambulation, sedation, incidence of side-effects, maternal, and neonatal outcomes. Settings and Design: This is prospective, randomized, controlled, double-blinded, study of 120 patients consenting for labor analgesia. Subjects and Methods: A total of 120 primiparas with a singleton pregnancy in active labor who were given combined spinal epidural (CSE were included in the study. These patients were randomly allocated to three groups of 40 each and received CSE. Group F-received 25 μcg fentanyl intrathecally. Group BF-received 25 μcg fentanyl with 2.5 mg isobaric bupivacaine intrathecally. Group RF-received 25 μcg fentanyl with 2.5 mg isobaric ropivacaine intrathecally. Statistical Analysis Used: Correlations among different measurements were assessed using Pearson′s correlation coefficients, P <0.05 was considered to be statistically significant. Results: The three groups show comparable demographic data and obstetric parameters. The duration of spinal analgesia was significantly greater with Group RF 106.63 ± 17.99 min and Group BF 111.75 ± 23.58 min than the control Group F which was 60 ± 10.39 min with P = 0.001, but were comparable for Group BF and RF. The secondary outcome was comparable in all the three groups. Conclusions: The addition of bupivacaine or ropivacaine to fentanyl intrathecally increased duration and quality of analgesia, did not affect ambulation and bearing down. The

  16. Double blind clinical trail comparing the safety and efficacy of ...

    African Journals Online (AJOL)

    Double blind clinical trail comparing the safety and efficacy of nimesulide (100g) and diclofenac in osteoarthrosis of the hip and knee joints. ... A significant proportion of the patients in the diclofenac group (50% vs 17.6%) had break through pain that warranted the use of at least two tablets of 500mg of paracetamol per week ...

  17. A randomized, double-blind, multicentre study comparing daily 2 and 5 mg of tropisetron for the control of nausea and vomiting induced by low-dose cisplatin- or non-cisplatin-containing chemotherapy

    NARCIS (Netherlands)

    Wymenga, ANM; vanderGraaf, WTA; Wils, JA; vanHeukelom, LS; vanderLinden, GHM; DullemondWestland, AC; Nooy, M; vanderHeul, C; deBruijn, KM; deVries, EGE

    Background: This study compares efficacy safety and tolerability of 2 and 5 mg tropisetron in prevention of nausea and vomiting induced by low-dose cisplatin- or non-cisplatin-containing chemotherapy. Patients and methods: 152 chemotherapy-naive cancer patients were randomized in a double-blind

  18. Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study.

    Science.gov (United States)

    Cohen, Stanley; Genovese, Mark C; Choy, Ernest; Perez-Ruiz, Fernando; Matsumoto, Alan; Pavelka, Karel; Pablos, Jose L; Rizzo, Warren; Hrycaj, Pawel; Zhang, Nan; Shergy, William; Kaur, Primal

    2017-10-01

    ABP 501 is a Food and Drug Administration-approved biosimilar to adalimumab; structural, functional and pharmacokinetic evaluations have shown that the two are highly similar. We report results from a phase III study comparing efficacy, safety and immunogenicity between ABP 501 and adalimumab. In this randomised, double-blind, active comparator-controlled, 26-week equivalence study, patients with moderate to severe active rheumatoid arthritis (RA) despite methotrexate were randomised (1:1) to ABP 501 or adalimumab (40 mg) every 2 weeks. Primary endpoint was risk ratio (RR) of ACR20 between groups at week 24. Primary hypothesis that the treatments were equivalent would be confirmed if the 90% CI for RR of ACR20 at week 24 fell between 0.738 and 1.355, demonstrating that ABP 501 is similar to adalimumab. Secondary endpoints included Disease Activity Score 28-joint count-C reactive protein (DAS28-CRP). Safety was assessed via adverse events (AEs) and laboratory evaluations. Antidrug antibodies were assessed to determine immunogenicity. A total of 526 patients were randomised (n=264, ABP 501; n=262 adalimumab) and 494 completed the study. ACR20 response at week 24 was 74.6% (ABP 501) and 72.4% (adalimumab). At week 24, the RR of ACR20 (90% CI) between groups was 1.039 (0.954, 1.133), confirming the primary hypothesis. Changes from baseline in DAS28-CRP, ACR50 and ACR70 were similar. There were no clinically meaningful differences in AEs and laboratory abnormalities. A total of 38.3% (ABP 501) and 38.2% (adalimumab) of patients tested positive for binding antidrug antibodies. Results from this study demonstrate that ABP 501 is similar to adalimumab in clinical efficacy, safety and immunogenicity in patients with moderate to severe RA. NCT01970475; Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  19. Piracetam relieves symptoms in progressive myoclonus epilepsy: a multicentre, randomised, double blind, crossover study comparing the efficacy and safety of three dosages of oral piracetam with placebo

    Science.gov (United States)

    Koskiniemi, M.; Van Vleymen, B.; Hakamies, L.; Lamusuo, S.; Taalas, J.

    1998-01-01

    OBJECTIVE—To compare the efficacy, tolerability, and safety of three daily dosage regimens of oral piracetam in patients with progressive myoclonus epilepsy.
METHODS—Twenty patients (12 men, eight women), aged 17-43 years, with classical Unverricht-Lundborg disease were enrolled in a multicentre, randomised, double blind trial of crossover design in which the effects of daily doses of 9.6 g, 16.8 g, and 24 g piracetam, given in two divided doses, were compared with placebo. The crossover design was such that patients received placebo and two of the three dosage regimens of piracetam, each for two weeks, for a total treatment period of six weeks and thus without wash out between each treatment phase. The primary outcome measure was a sum score representing the adjusted total of the ratings of six components of a myoclonus rating scale in which stimulus sensitivity, motor impairment, functional disability, handwriting, and global assessments by investigators and patients were scored. Sequential clinical assessments were made by the same neurologist in the same environment at the same time of day.
RESULTS—Treatment with 24 g/day piracetam produced significant and clinically relevant improvement in the primary outcome measure of mean sum score (p=0.005) and in the means of its subtests of motor impairment (p=0.02), functional disability (p=0.003), and in global assessments by both investigator (p=0.002) and patient (p=0.01). Significant improvement in functional disability was also found with daily doses of 9.6 g and 16.8 g. The dose-effect relation was linear and significant. More patients showed clinically relevant improvement with the highest dosage and, in individual patients, increasing the dose improved response. Piracetam was well tolerated and adverse effects were few, mild, and transient.
CONCLUSIONS—This study provides further evidence that piracetam is an effective and safe medication in patients with Unverricht-Lundborg disease. In addition

  20. A randomized, double-blind trial comparing combinations of nevirapine, didanosine, and zidovudine for HIV-infected patients: the INCAS Trial. Italy, The Netherlands, Canada and Australia Study.

    Science.gov (United States)

    Montaner, J S; Reiss, P; Cooper, D; Vella, S; Harris, M; Conway, B; Wainberg, M A; Smith, D; Robinson, P; Hall, D; Myers, M; Lange, J M

    1998-03-25

    Current guidelines recommend that individuals infected with the human immunodeficiency virus type 1 (HIV-1) be treated using combinations of antiretroviral agents to achieve sustained suppression of viral replication as measured by the plasma HIV-1 RNA assay, in the hopes of achieving prolonged remission of the disease. However, until recently, many drug combinations have not led to sustained suppression of HIV-1 RNA. To compare the virologic effects of various combinations of nevirapine, didanosine, and zidovudine. Double-blind, controlled, randomized trial. University-affiliated ambulatory research clinics in Italy, the Netherlands, Canada and Australia (INCAS). Antiretroviral therapy-naive adults free of the acquired immunodeficiency syndrome with CD4 cell counts between 0.20 and 0.60x10(9)/L (200-600/microL). Patients received zidovudine plus nevirapine (plus didanosine placebo), zidovudine plus didanosine (plus nevirapine placebo), or zidovudine plus didanosine plus nevirapine. Plasma HIV-1 RNA. Of the 153 enrolled patients, 151 were evaluable. At week 8, plasma HIV-1 RNA levels had decreased by log 2.18, 1.55, and 0.90 in the triple drug therapy, zidovudine plus didanosine, and zidovudine plus nevirapine groups, respectively (P<.05). The proportions of patients with plasma HIV-1 RNA levels below 20 copies per milliliter at week 52 were 51%, 12%, and 0% in the triple drug therapy, zidovudine plus didanosine, and zidovudine plus nevirapine groups, respectively (P<.001). Viral amplification was attempted in 59 patients at 6 months. Viral isolation was unsuccessful in 19 (79%) of 24, 10 (53%) of 19, and 5 (31%) of 16 patients in the triple drug therapy, zidovudine plus didanosine, and zidovudine plus nevirapine groups, respectively. Among patients from whom virus could be amplified, resistance to nevirapine was found in all 11 patients receiving zidovudine plus nevirapine and in all 5 patients receiving triple drug therapy. Rates of disease progression or death

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

    Directory of Open Access Journals (Sweden)

    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

  2. A COMPARATIVE STUDY OF TRANEXAMIC ACID VERSUS ETHAMSYLATE USED PROPHYLACTICALLY IN LOWER SEGMENT CAESAREAN SECTION- A PROSPECTIVE RANDOMISED DOUBLE-BLINDED STUDY

    Directory of Open Access Journals (Sweden)

    Bondada Suryakumari

    2017-09-01

    Full Text Available BACKGROUND Recently, caesarean section rates are increased in developing countries like India. Postpartum haemorrhage is more after caesarean section. Most of the maternal mortality is attributed to postpartum haemorrhage. This study was undertaken to find out the drug effective in reducing blood loss in lower segment caesarean section. The aim of the study is to compare the efficacy of ethamsylate versus tranexamic acid in reducing blood loss during and after caesarean section. MATERIALS AND METHODS All women undergoing LSCS were divided in 3 groups, viz. 2 study groups and control group. All were requested for preop and postop Hb%, PCV and TRBC. Tranexamic acid and ethamsylate, 1 g diluted in 10 mL NS were given intravenously for both the study groups and control group with NS, 20 minutes prior to skin incision and blood loss was measured from placental delivery up to 2 hours in all the groups was calculated by weighing pre-weighted pads soaked in blood. RESULTS Statistical analysis was done quantitatively by Student’s t-test. Postoperative blood loss was similar and lower in both the study groups compared to the control group. Hb% change in postop period is significant in control group. CONCLUSION Ethamsylate is safe and effective alternative to tranexamic acid in preventing postpartum haemorrhage after caesarean section.

  3. Effects of policosanol on borderline to mildly elevated serum total cholesterol levels: a prospective, double-blind, placebo-controlled, parallel-group, comparative study

    Directory of Open Access Journals (Sweden)

    Gladys Castaño, PhD

    2003-09-01

    Full Text Available Background: Hypercholesterolemia is a major risk factor for coronary heart disease. Clinical studies have shown that lowering elevated serum cholesterol levels, particularly low-density lipoprotein cholesterol (LDL-C, is beneficial for patients with borderline to mildly elevated serum total cholesterol (TC levels (5.0–6.0 mmol/L. Policosanol is a cholesterol-lowering drug made from purified sugar cane wax. The therapeutic range of policosanol is 5 to 20 mg/d. Objective: This study investigated the efficacy and tolerability of policosanol 5 mg/d in patients with borderline to mildly elevated serum TC levels. Methods: This 14-week, single-center, prospective, double-blind, placebo-controlled, parallel-group, comparative study was conducted in men and women aged 25 to 75 years with a serum TC level ≥4.8 to <6.0 mmol/L. After a 6-week run-in period in which patients were placed on therapeutic lifestyle changes, in particular a cholesterol-lowering diet, patients were randomly assigned to receive policosanol 5-mg tablets or placebo tablets once daily with the evening meal for 8 weeks, and the diet was continued throughout the study. Lipid profile variables, safety indicators, adverse events (AEs, and compliance with study medications were assessed. Results: One hundred patients (71 women, 29 men; mean [SD] age, 52 [10] years entered the study after the dietary run-in period. After 8 weeks of treatment, the mean (SD serum LDL-C level decreased significantly in the policosanol group (P<0.001 vs baseline and placebo from 3.57 (0.30 mmol/L to 2.86 (0.41 mmol/L (change, −19.9%. Significantly more patients in the policosanol group (42 patients [84%] achieved a ≥15% decrease in serum LDL-C than in the placebo group (2 patients [4%] (P<0.001. Also in the policosanol group, the mean (SD serum TC level decreased significantly, from 5.20 (0.22 mmol/L to 4.56 (0.44 mmol/L (P<0.001 vs baseline and placebo (change, −12.3%; the mean (SD triglyceride (TG

  4. Double-Blind Crossover Study to Compare Pain Experience During Inferior Alveolar Nerve Block Administration Using Buffered Two Percent Lidocaine in Children.

    Science.gov (United States)

    Chopra, Radhika; Jindal, Garima; Sachdev, Vinod; Sandhu, Meera

    2016-01-01

    Buffering of anesthetic solutions has been suggested to reduce pain on injection and onset of anesthesia. The purpose of this study was to assess the reduction in pain on injection during inferior alveolar nerve block administration in children. A double blind crossover study was designed where 30 six- to 12-year-old patients received two sessions of inferior alveolar nerve block scheduled one week apart. Two percent lidocaine with 1:200,000 epinephrine was given during one appointment, and a buffered solution was given during the other. Pain on injection was assessed using the sound, eye, and motor (SEM) scale, and the time to onset was assessed after gingival probing. The Heft-Parker visual analogue scale (HP-VAS) was self recorded by the patient after administration of local anesthesia. When tested using Mann-Whitney analysis, no significant differences were found between the SEM scores (P=0.71) and HP-VAS scores (P=0.93) for the two solutions used. Student's t test was used to assess the difference in the onset of anesthesia, which was also found to be statistically insignificant (P=0.824). Buffered lidocaine did not reduce the pain on injection or time to onset of anesthesia for inferior alveolar nerve block in children.

  5. Double-blind randomized phase III study comparing a mixture of natural agents versus placebo in the prevention of acute mucositis during chemoradiotherapy for head and neck cancer.

    Science.gov (United States)

    Marucci, Laura; Farneti, Alessia; Di Ridolfi, Paolo; Pinnaro, Paola; Pellini, Raul; Giannarelli, Diana; Vici, Patrizia; Conte, Mario; Landoni, Valeria; Sanguineti, Giuseppe

    2017-09-01

    There is no widely accepted intervention in the prevention of acute mucositis during chemoradiotherapy for head and neck carcinoma. In the present double-blind study, we tested 4 natural agents, propolis, aloe vera, calendula, and chamomile versus placebo. Patients undergoing concomitant chemo-intensity-modulated radiotherapy (IMRT) were given natural agent or matched placebo; grade 3 mucositis on physical examination according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was the primary endpoint. Various covariates were tested at logistic regression, including the individual amount of mucosa receiving at least 9.5 Gy per week (V9.5w). One hundred seven patients were randomized from January 2011 to July 2014, and 104 were assessable (51%-49% were assigned to the placebo group and 53%-51% were assigned to the natural agent). Overall, 61 patients developed peak grade 3 mucositis with no difference between arms (P = .65). Conversely, V9.5w (P = .007) and primary site (P = .037) were independent predictors. The selected natural agents do not prevent mucositis, whereas the role of V9.5w is confirmed. © 2017 Wiley Periodicals, Inc.

  6. Effect of inspiratory muscle training with load compared with sham training on blood pressure in individuals with hypertension: study protocol of a double-blind randomized clinical trial.

    Science.gov (United States)

    Posser, Simone Regina; Callegaro, Carine Cristina; Beltrami-Moreira, Marina; Moreira, Leila Beltrami

    2016-08-02

    Hypertension is a complex chronic condition characterized by elevated arterial blood pressure. Management of hypertension includes non-pharmacologic strategies, which may include techniques that effectively reduce autonomic sympathetic activity. Respiratory exercises improve autonomic control over cardiovascular system and attenuate muscle metaboreflex. Because of these effects, respiratory exercises may be useful to lower blood pressure in subjects with hypertension. This randomized, double-blind clinical trial will test the efficacy of inspiratory muscle training in reducing blood pressure in adults with essential hypertension. Subjects are randomly allocated to intervention or control groups. Intervention consists of inspiratory muscle training loaded with 40 % of maximum inspiratory pressure, readjusted weekly. Control sham intervention consists of unloaded exercises. Systolic and diastolic blood pressures are co-primary endpoint measures assessed with 24 h ambulatory blood pressure monitoring. Secondary outcome measures include cardiovascular autonomic control, inspiratory muscle metaboreflex, cardiopulmonary capacity, and inspiratory muscle strength and endurance. Previously published work suggests that inspiratory muscle training reduces blood pressure in persons with hypertension, but the effectiveness of this intervention is yet to be established. We propose an adequately sized randomized clinical trial to test this hypothesis rigorously. If an effect is found, this study will allow for the investigation of putative mechanisms to mediate this effect, including autonomic cardiovascular control and metaboreflex. ClinicalTrials.gov NCT02275377 . Registered on 30 September 2014.

  7. Randomised, prospective, non-blinded pilot study comparing the effect of intramuscular steroid injections and intralesional steroid injections in the management of tennis elbow

    Science.gov (United States)

    Tahir, Hasan; Biro, Izolda; Donnelly, Simon; Greenwood, Mandy

    2016-01-01

    Background Tennis elbow is an overuse injury affecting people performing repetitive forearm movements. It is a soft tissue disorder that causes significant disability and pain. The aim of the study was to establish that an intramuscular steroid injection is effective in the short-term pain relief and functional improvement of tennis elbow. The severity of pain at the injection site was monitored to determine whether the intramuscular injection is better tolerated than the intralesional injection. Methods and results 19 patients, who had no treatment for tennis elbow in the preceding 3 months, were recruited from Whipps Cross University Hospital, London, and were randomised to receive either 80 mg of intramuscular Depo-Medrone or 40 mg of intralesional Depo-Medrone injection. Blinding proved difficult as the injection sites differed and placebo arms were not included in the study. A Patient-Rated Tennis Elbow Evaluation (PRTEE) Questionnaire and a 10-point Likert scale were used to assess primary outcome. Six weeks after the treatment, there was a reduction in pain, improvement in function and total PRTEE scores in both intramuscular and intralesional groups (p=0.008) using a 95% CI for mean treatment difference of −26 to +16 points. A statistically significant result (p=0.001) in favour of intramuscular causing less pain at the injection site was noted. Conclusion Non-inferiority of intramuscular to intralesional injections was not confirmed; however, the intramuscular injection proved to be effective in reducing tennis elbow-related symptoms and was found less painful at the site of injection at the time of administration. Trial registration number EUDRACT Number: 2010-022131-11. REC Number: 10/H0718/76 (NRES, Central London REC 1). PMID:28879024

  8. Faster onset of antidepressant effects of citalopram compared with sertraline in drug-naïve first-episode major depressive disorder in a Chinese population: a 6-week double-blind, randomized comparative study.

    Science.gov (United States)

    Hsu, Ju-Wei; Su, Tung-Ping; Huang, Chen-Ying; Chen, Ying-Sheue; Chou, Yuan-Hwa

    2011-10-01

    Several previous studies, including a meta-analysis, reported no significant differences between various selective serotonin reuptake inhibitors (SSRIs) in the treatment of major depressive disorder. However, because of the different chemical structure of SSRIs and the difference in the frequency of serotonin transporter polymorphisms between ethnic groups, a head-to-head comparative study between SSRIs in different populations may be enlightening. We compared the efficacy and adverse effect profiles of citalopram and sertraline in a double-blinded randomized clinical trial in a Chinese population of drug-naïve patients with first-episode major depressive disorder. Fifty-one patients were randomly assigned to citalopram or sertraline treatment. The Montgomery-Åsberg Depression Rating Scale (MADRS) was used as the primary outcome. Efficacy and adverse effects were analyzed in an intent-to-treat population. Efficacy was analyzed using a last-observation-carried-forward method for early terminators. There were no significant differences in demographic characteristics at baseline. No significant differences were found in MADRS scores between citalopram and sertraline at baseline (36.6 ± 5.5 vs 38.2 ± 4.9; P = 0.322) or at the end of treatment (week 6; 10.8 ± 10.0 vs 16.7 ± 11.3; P = 0.082). However, MADRS scores in the citalopram group were significantly lower at week 1 (25.2 ± 8.5 vs 30.4 ± 6.1; P = 0.029) and week 3 (15.9 ± 10.0 vs 22.1 ± 8.7; P = 0.037). Overall, treatment-emergent adverse effects were reported by 14.3% and 28.6% of patients in the citalopram and sertraline groups, respectively. In conclusion, citalopram and sertraline were both efficacious and well tolerated. However, citalopram exhibited a significantly faster onset than sertraline during the early weeks of treatment and tended to have a better efficacy in overall treatment, although the statistic was not significant.

  9. A randomized double-blind crossover trial comparing subthalamic and pallidal deep brain stimulation for dystonia

    DEFF Research Database (Denmark)

    Schjerling, Lisbeth; Hjermind, Lena E; Jespersen, Bo

    2013-01-01

    Object The authors' aim was to compare the subthalamic nucleus (STN) with the globus pallidus internus (GPi) as a stimulation target for deep brain stimulation (DBS) for medically refractory dystonia. Methods In a prospective double-blind crossover study, electrodes were bilaterally implanted in ...

  10. Randomized, double-blind, comparative study on efficacy and safety of itraconazole pulse therapy and terbinafine pulse therapy on nondermatophyte mold onychomycosis: A study with 90 patients.

    Science.gov (United States)

    Ranawaka, Ranthilaka R; Nagahawatte, Ajith; Gunasekara, Thusitha Aravinda; Weerakoon, Hema S; de Silva, S H Padmal

    2016-08-01

    Nondermatophyte mold (NDM) onychomycosis shows poor response to current topical, oral or device-related antifungal therapies. This study was aimed to determine the efficacy and safety of itraconazole and terbinafine pulse therapy on NDM onychomycosis. Mycologically proven subjects were treated with itraconazole 400 mg daily or terbinafine 500 mg daily for 7 days/month; two pulses for fingernails and three pulses for toenails(SLCTR/2013/013). One-hundred seventy-eight patients underwent mycological studies and 148 had positive fungal isolates. NDM were the prevailing fungi, 68.2%, followed by candida species 21.6%, and dermatophytes made up only 10.1%. Out of NDM Aspergillus spp (75.1%) predominated followed by 8.9% Fusarium spp and 4.95% Penicillium spp. The clinical cure at completion of pulse therapy was statistically significant 9.2% versus 2.0% (p terbinafine pulse cured 55.0% Aspergillus spp and 50.0% Fusarium spp. NDM was the prevailing fungi in onychomycosis in Sri Lanka. Both itraconazole and terbinafine were partially effective on NDM onychomycosis showing a clinical cure of 54-65%. Future research should focus on searching more effective antifungal for NDM onychomycosis.

  11. Comparing oxytocin and cortisol regulation in a double-blind, placebo-controlled, hydrocortisone challenge pilot study in children with autism and typical development.

    Science.gov (United States)

    Corbett, Blythe A; Bales, Karen L; Swain, Deanna; Sanders, Kevin; Weinstein, Tamara A R; Muglia, Louis J

    2016-01-01

    Children with autism spectrum disorder (ASD) show marked impairment in social functioning and poor adaptation to new and changing contexts, which may be influenced by underlying regulatory processes. Oxytocin (OT) and cortisol are key neuromodulators of biological and behavioral responses, show a synergistic effect, and have been implicated in the neuropathological profile in ASD. However, they are rarely investigated together. The purpose of the pilot study was to evaluate the relationship between cortisol and OT in children with ASD under baseline and physiological stress (hydrocortisone challenge) conditions. Arginine vasopressin (AVP), structurally similar to OT, was also examined. A double-blind, placebo-controlled, randomly assigned, crossover design was employed in 25 children 8-to-12 years with ASD (N = 14) or typical development (TD, N = 11). A low dose of hydrocortisone and placebo were administered via liquid suspension. Analysis of variance (ANOVA) was used to examine the within-subject factor "Condition" (hydrocortisone/placebo) and "Time" (pre and post) and the between-subject factor "Group" (ASD vs. TD). Pearson correlations examined the relationship between hormone levels and clinical profile. There was a significant Time × Condition × Group interaction F (1.23) = 4.18, p = 0.05 showing a rise in OT during the experimental condition (hydrocortisone) and a drop during the placebo condition for the TD group but not the ASD group. There were no group differences for AVP. Hormone levels were associated with social profiles. For the TD group, an inverse relationship was observed. OT increased during physiological challenge suggesting that OT played a stress-buffering role during cortisol administration. In contrast for the ASD group, OT remained unchanged or decreased during both the physiological challenge and the placebo condition, suggesting that OT failed to serve as a stress buffer under conditions of physiological stress. While

  12. A comparative analysis of avoidable causes of childhood blindness in Malaysia with low income, middle income and high income countries.

    Science.gov (United States)

    Koay, C L; Patel, D K; Tajunisah, I; Subrayan, V; Lansingh, V C

    2015-04-01

    To determine the avoidable causes of childhood blindness in Malaysia and to compare this to other middle income countries, low income countries and high income countries. Data were obtained from a school of the blind study by Patel et al. and analysed for avoidable causes of childhood blindness. Six other studies with previously published data on childhood blindness in Bangladesh, Ethiopia, Nigeria, Indonesia, China and the United Kingdom were reviewed for avoidable causes. Comparisons of data and limitations of the studies are described. Prevalence of avoidable causes of childhood blindness in Malaysia is 50.5 % of all the cases of childhood blindness, whilst in the poor income countries such as Bangladesh, Ethiopia, Nigeria and Indonesia, the prevalence was in excess of 60 %. China had a low prevalence, but this is largely due to the fact that most schools were urban, and thus did not represent the situation of the country. High income countries had the lowest prevalence of avoidable childhood blindness. In middle income countries, such as Malaysia, cataract and retinopathy of prematurity are the main causes of avoidable childhood blindness. Low income countries continue to struggle with infections such as measles and nutritional deficiencies, such as vitamin A, both of which are the main contributors to childhood blindness. In high income countries, such as the United Kingdom, these problems are almost non-existent.

  13. A double-blind, randomized study comparing pure chromated glycerin with chromated glycerin with 1% lidocaine and epinephrine for sclerotherapy of telangiectasias and reticular veins.

    Science.gov (United States)

    Kern, Philippe; Ramelet, Albert-Adrien; Wutschert, Robert; Mazzolai, Lucia

    2011-11-01

    Chromated glycerin (CG) is an effective, although painful, sclerosing agent for telangiectasias and reticular leg veins treatment. To determine pain level and relative efficacy of pure or one-third lidocaine-epinephrine 1% mixed chromated glycerin in a prospective randomized double-blind trial. Patients presenting with telangiectasias and reticular leg veins on the lateral aspect of the thigh (C(1A) or (S) E(P) A(S) P(N1) ) were randomized to receive pure CG or CG mixed with one-third lidocaine-epinephrine 1% (CGX) treatment. Lower limb photographs were taken before and after treatment and analyzed by blinded expert reviewers for efficacy assessment (visual vein disappearance). Patients' pain and satisfaction were assessed using visual analogue scales. Data from 102 of 110 randomized patients could be evaluated. Patient pain scores were significantly higher when pure CG was used than with CGX (psclerotherapy pain without affecting efficacy when treating telangiectasias and reticular leg veins. © 2011 by the American Society for Dermatologic Surgery, Inc.

  14. [Efficacy of intravenous dexketoprofen trometamol compared to intravenous paracetamol for postoperative pain management after day-case operative hysteroscopy: randomized, double-blind, placebo-controlled study].

    Science.gov (United States)

    Koçum, Aysu; Sener, Mesut; Izmirli, Hatice; Haydardedeoğlu, Bülent; Arıboğan, Anış

    2014-01-01

    Adequate pain management following day-case surgery allows early ambulation of patients. In this study, we aimed to compare postoperative analgesic efficacy of intravenous (iv) dexketoprofen vs. iv paracetamol following day-case operative hysteroscopy. One hundred and fourteen American Society of Anesthesiologists (ASA) I-II patients scheduled for day-case operative hysteroscopy were recruited and randomized to three groups in the study. Group D received 50 mg iv dexketoprofen trometamol, Group P 1000 mg iv paracetamol and Group C normal saline solution. Visual Analogue Scale (VAS) pain intensity, pain relief, sedation, nausea-vomiting, other side effects, and additional opioid analgesic requirement were noted at postoperative 15 minutes (min), 30 min, 1 hour (h), 2 h, and 3 h. Patients with VAS>=40 mm received meperidine 0.25 mg/kg as rescue analgesic medication. VAS scores at 15 min, 30 min, 1 h, and 2 h were significantly lower in Group D compared to Group C. VAS scores at 15 min and 30 min were significantly lower in Group D compared to Group P. The percentages of patients who required opioid treatment were 34%, 60%, and 63% in Groups D, P and C, respectively (pdexketoprofen has superior efficacy for postoperative pain management following day-case operative hysteroscopy when compared with paracetamol and placebo.

  15. A single-blind study of the efficacy and safety of intravenous granisetron compared with alizapride plus dexamethasone in the prophylaxis and control of emesis in patients receiving 5-day cytostatic therapy. The Granisetron Study Group.

    Science.gov (United States)

    Bremer, K

    1992-01-01

    200 cancer patients who were due to receive fractionated chemotherapy (cisplatin greater than or equal to 15, ifosfamide greater than or equal to 1.2 or etoposide greater than or equal to 120, all mg/m2 per day) for 5 days, entered a multicentre study. Patients were randomised single-blind to receive either prophylactic intravenous granisetron (40 micrograms/kg) or alizapride (4 mg/kg followed by 4 mg/kg at 4 and 8 h post-treatment) plus dexamethasone 8 mg. Granistron was superior to the combination in preventing nausea and vomiting (54% vs. 43% complete responders). The differences were in the cisplatin-treated group. The time to first episode of moderate to severe nausea was significantly longer in the granisetron group (P = 0.03). Dosing with granisetron was more simple, with over 85% of patients requiring only a single prophylactic dose. Fewer patients receiving granisetron experienced adverse events (48% vs. 62%, P = 0.047). The frequency of constipation was, as expected, significantly higher in the granisetron group. Extrapyramidal effects, which were not noted by any granisetron patient, occurred in 5.3% of comparator patients.

  16. A randomized, double-blind study comparing the efficacy of selenium sulfide shampoo 1% and ciclopirox shampoo 1% as adjunctive treatments for tinea capitis in children.

    Science.gov (United States)

    Chen, Catherine; Koch, Laine H; Dice, James E; Dempsey, Kimberly K; Moskowitz, Alan B; Barnes-Eley, Myra L; Hubbard, Thomas W; Williams, Judith V

    2010-01-01

    Our objective was to compare the efficacy of selenium sulfide shampoo 1% and ciclopirox shampoo 1% as adjunctive treatments for tinea capitis in children. Forty children aged 1-11 years with clinically diagnosed tinea capitis were randomized to receive selenium sulfide shampoo 1% or ciclopirox shampoo 1% twice a week as adjuncts to an 8-week course of ultramicronized griseofulvin dosed at 10-12 mg/kg/day. At weeks 2, 4, and 8, subjects returned to the clinic for evaluation and scalp cultures. Subjects then returned for follow-up visits 4 weeks after completing treatment. Overall, by 8 weeks, 30 of 33 (90.9%) treated children demonstrated mycological cure. Selenium sulfide shampoo 1% and ciclopirox shampoo 1% were equally effective as adjunctive treatments for tinea capitis in children in our study. © 2010 Wiley Periodicals, Inc.

  17. Reduction in sodium content of local anesthetics for peripheral nerve blocks: a comparative evaluation of saline with 5% dextrose--a randomized controlled double-blind study.

    Science.gov (United States)

    Dhir, Shalini; Tureanu, Luminita; Bouzari, Amir; Masood, Amna; Francispragasam, Mario; Ganapathy, Sugantha

    2012-06-01

    Commercially available local anesthetic drugs when diluted with normal saline have high sodium content. High perineural sodium concentration has been implicated in antagonizing the analgesic effects of local anesthetics by preventing and/or delaying neural blockade. Five percent dextrose is not known to cause any short- or long-term injury when injected around neural tissue. In this study, we prospectively compared and evaluated block characteristics when local anesthetic drug was diluted with these 2 different agents. Patients scheduled for upper limb surgery were randomly assigned to receive axillary brachial plexus block with 0.5% ropivacaine (1% diluted with either 5% dextrose or normal saline). Motor and sensory block were tested every 5 minutes for 30 minutes. Postoperatively, a telephone interview was conducted after 24 hours and 7 days along with surgical follow-up at days 3, 10, and/or 14 to 28 days to document side effects, patient satisfaction, and time for block resolution. Any nerve deficits were followed until resolution. The primary outcome was time to onset of sensory nerve block. Five hundred fifty patients were recruited for this study. The mean time to complete sensory block was 18.3 ± 6.1 minutes in the dextrose group and 22.5 ± 6.4 minutes in the saline group (P dextrose provides earlier onset of axillary brachial plexus block with ropivacaine.

  18. Randomized, double-blind, crossover study of palonosetron compared with granisetron for the prevention of chemotherapy-induced nausea and vomiting in a Chinese population.

    Science.gov (United States)

    Tian, Weihua; Wang, Zhiqiang; Zhou, Juntian; Zhang, Shucai; Wang, Jinghui; Chen, Qiang; Huang, Cheng; Pan, Liangxi; Zhang, Lili; Huang, Jianjin; Shen, Hong; Lin, Tongyu

    2011-03-01

    The objective of this study was to compare the efficacy and tolerability of palonosetron and granisetron in a Chinese population receiving highly emetogenic cisplatin-based chemotherapy or moderately emetogenic chemotherapy. Patients were stratified by chemotherapy with cisplatin (yes/no) and then randomly assigned to receive either palonosetron (0.25 mg i.v.) in the first cycle followed by granisetron (3 mg i.v.) in the second cycle or vice versa. The primary efficacy endpoint was the proportion of patients with complete response 0-24 h post-chemotherapy administration. The proportions of patients with complete response 24-120 and 0-120 h following chemotherapy were also compared. Of the 144 patients randomized, 36 (25%) received 60-80 mg/m(2) cisplatin; 66 of 72 patients in the palonosetron to granisetron group and 56 of 72 patients in the granisetron to palonosetron group completed treatment with both antiemetics. The efficacy and safety analyses included 128 palonosetron treatments and 138 granisetron treatments. Palonosetron consistently produced numerically higher complete response rates than granisetron in the acute phase (0-24 h, 71.09 vs. 65.22%), the delayed phase (24-120 h, 60.16 vs. 55.80%), and overall (0-120 h, 53.13 vs. 50.00%) though the differences were not significant. Both palonosetron and granisetron were well tolerated. Palonosetron was well tolerated and effective in preventing acute and delayed chemotherapy-induced nausea and vomiting in a Chinese population. When used as monotherapy, 0.25-mg palonosetron was not inferior to 3-mg granisetron for preventing vomiting following highly or moderately emetogenic chemotherapy.

  19. Aspartame Sensitivity? A Double Blind Randomised Crossover Study

    OpenAIRE

    Sathyapalan, Thozhukat; Thatcher, Natalie J.; Hammersley, Richard; Rigby, Alan S.; Pechlivanis, Alexandros; Gooderham, Nigel J.; Holmes, Elaine; le Roux, Carel W.; Atkin, Stephen L.; Courts, Fraser

    2015-01-01

    Background 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. Methods This was a double-blind randomized cross over study conducted in a clinical research unit in United Kingdom. Forty-eight indivi...

  20. Short-term efficacy of calcium fructoborate on subjects with knee discomfort: a comparative, double-blind, placebo-controlled clinical study

    Directory of Open Access Journals (Sweden)

    Pietrzkowski Z

    2014-06-01

    Full Text Available Zbigniew Pietrzkowski,1 Michael J Phelan,2 Robert Keller,3 Cynthia Shu,1 Ruby Argumedo,1 Tania Reyes-Izquierdo11FutureCeuticals, Inc., Applied BioClinical Laboratory; 2Department of Statistics, School of Information and Computer Science, University of California at Irvine; 3NutraClinical Inc., Irvine, CA, USAAbstract: Calcium fructoborate (CFB at a dose of 110 mg twice per day was previously reported to improve knee discomfort during the first 14 days of treatment. In this study, 60 participants with self-reported knee discomfort were randomized into two groups receiving CFB or placebo. Initial levels of knee discomfort were evaluated by Western Ontario and McMaster Universities Arthritis Index (WOMAC and McGill Pain Questionnaire (MPQ scores at the beginning of the study and also at 7 and 14 days after treatment. Results showed that supplementation with CFB significantly improved knee discomfort in the study subjects; significant reductions of mean within-subject change in WOMAC and MPQ scores were observed for the CFB group compared to the placebo group at both 7 and 14 days after treatment. Estimated treatment differences for the MPQ score were -5.8 (P=0.0009 and -8.9 (P<0.0001 at Day 7 and 14, respectively. Estimated differences for the WOMAC score were -5.3 (P=0.06 and -13.73 (P<0.0001 at Day 7 and 14, respectively. Negative values indicate greater reductions in reported discomfort. On both Day 7 and Day 14, the trend was toward greater improvement in the CFB group. The placebo group did not exhibit any change in the WOMAC and MPQ scores. In conclusion, supplementation with 110 mg CFB twice per day was associated with improving knee discomfort during the 2 weeks of intake.Keywords: CFB, joint discomfort, WOMAC score, McGill pain score

  1. Migration and head penetration of Vitamin-E diffused cemented polyethylene cup compared to standard cemented cup in total hip arthroplasty: study protocol for a randomised, double-blind, controlled trial (E1 HIP).

    Science.gov (United States)

    Sköldenberg, Olof; Rysinska, Agata; Chammout, Ghazi; Salemyr, Mats; Muren, Olle; Bodén, Henrik; Eisler, Thomas

    2016-07-07

    In vitro, Vitamin-E-diffused, highly cross-linked polyethylene (PE) has been shown to have superior wear resistance and improved mechanical properties when compared to those of standard highly cross-linked PE liners used in total hip arthroplasty (THA). The aim of the study is to evaluate the safety of a new cemented acetabular cup with Vitamin-E-doped PE regarding migration, head penetration and clinical results. In this single-centre, double-blinded, randomised controlled trial, we will include 50 patients with primary hip osteoarthritis scheduled for THA and randomise them in a 1:1 ratio to a cemented cup with either argon gas-sterilised PE (control group) or Vitamin-E-diffused PE (vitamin-e group). All patients and the assessor of the primary outcome will be blinded and the same uncemented stem will be used for all participants. The primary end point will be proximal migration of the cup at 2 years after surgery measured with radiostereometry. Secondary end points include proximal migration at other follow-ups, total migration, femoral head penetration, clinical outcome scores and hip-related complications. Patients will be followed up at 3 months and at 1, 2, 5 and 10 years postoperatively. Results will be analysed using 95% CIs for the effect size. A regression model will also be used to adjust for stratification factors. The ethical committee at Karolinska Institutet has approved the study. The first results from the study will be disseminated to the medical community via presentations and publications in relevant medical journals when the last patient included has been followed up for 2 years. NCT02254980. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  2. A randomized, double-blind, multicenter Phase II study comparing the efficacy and safety of oral nemonoxacin with oral levofloxacin in the treatment of community-acquired pneumonia.

    Science.gov (United States)

    Liu, Yang; Zhang, Yingyuan; Wu, Jufang; Zhu, Demei; Sun, Shenghua; Zhao, Li; Wang, Xuefeng; Liu, Hua; Ren, Zhenyi; Wang, Changzheng; Xiu, Qingyu; Xiao, Zuke; Cao, Zhaolong; Cui, Shehuai; Yang, Heping; Liang, Yongjie; Chen, Ping; Lv, Yuan; Hu, Chengping; Lv, Xiaoju; Liu, Shuang; Kuang, Jiulong; Li, Jianguo; Wang, Dexi; Chang, Liwen

    2017-12-01

    To compare the clinical efficacy and safety of nemonoxacin with levofloxacin in treating community-acquired pneumonia (CAP) in a Phase II clinical trial. One hundred ninety-two patients with CAP were randomized to receive oral nemonoxacin (500 mg or 750 mg) or levofloxacin (500 mg) once daily for 7-10 days. Clinical and bacteriological responses were determined at the test of cure (TOC) visit in the full analysis set (FAS). The clinical cure rate of nemonoxacin (500 mg), nemonoxacin (750 mg), and levofloxacin (500 mg) was 93.3%, 87.3%, and 88.5%, respectively, in the FAS (n = 168), and 93.0%, 93.9%, and 88.9%, respectively in the per protocol set (n = 152). At the TOC visit, nemonoxacin at 500 mg and 750 mg was proven to be noninferior to levofloxacin at 500 mg in the FAS in terms of clinical efficacy. The overall bacteriological success rate was 83.3% in both nemonoxacin groups and 80.0% in the levofloxacin 500 mg group in the bacteriological FAS. The comprehensive efficacy rate was comparable among the three groups (87.5% for the nemonoxacin 500 mg group, 93.8% for the nemonoxacin 750 mg group, and 81.3% for the levofloxacin 500 mg group). Most drug-related adverse events were mild and transient, mainly gastrointestinal symptoms such as nausea and vomiting, transient neutropenia, and elevated liver enzymes. No drug-related serious adverse events occurred. Either 500 mg or 750 mg of oral nemonoxacin taken once daily for 7-10 days demonstrated high clinical and bacteriological success rates in Chinese adult patients with CAP. Nemonoxacin at 500 mg once daily for 7-10 days is recommended for future Phase III clinical trials. ClinicalTrials.gov identifier: NCT01537250. Copyright © 2015. Published by Elsevier B.V.

  3. Methods of a large prospective, randomised, open-label, blinded end-point study comparing morning versus evening dosing in hypertensive patients: the Treatment In Morning versus Evening (TIME) study.

    Science.gov (United States)

    Rorie, David A; Rogers, Amy; Mackenzie, Isla S; Ford, Ian; Webb, David J; Willams, Bryan; Brown, Morris; Poulter, Neil; Findlay, Evelyn; Saywood, Wendy; MacDonald, Thomas M

    2016-02-09

    Nocturnal blood pressure (BP) appears to be a better predictor of cardiovascular outcome than daytime BP. The BP lowering effects of most antihypertensive therapies are often greater in the first 12 h compared to the next 12 h. The Treatment In Morning versus Evening (TIME) study aims to establish whether evening dosing is more cardioprotective than morning dosing. The TIME study uses the prospective, randomised, open-label, blinded end-point (PROBE) design. TIME recruits participants by advertising in the community, from primary and secondary care, and from databases of consented patients in the UK. Participants must be aged over 18 years, prescribed at least one antihypertensive drug taken once a day, and have a valid email address. After the participants have self-enrolled and consented on the secure TIME website (http://www.timestudy.co.uk) they are randomised to take their antihypertensive medication in the morning or the evening. Participant follow-ups are conducted after 1 month and then every 3 months by automated email. The trial is expected to run for 5 years, randomising 10,269 participants, with average participant follow-up being 4 years. The primary end point is hospitalisation for the composite end point of non-fatal myocardial infarction (MI), non-fatal stroke (cerebrovascular accident; CVA) or any vascular death determined by record-linkage. Secondary end points are: each component of the primary end point, hospitalisation for non-fatal stroke, hospitalisation for non-fatal MI, cardiovascular death, all-cause mortality, hospitalisation or death from congestive heart failure. The primary outcome will be a comparison of time to first event comparing morning versus evening dosing using an intention-to-treat analysis. The sample size is calculated for a two-sided test to detect 20% superiority at 80% power. TIME has ethical approval in the UK, and results will be published in a peer-reviewed journal. UKCRN17071; Pre-results. Published by the BMJ

  4. Efficacy and safety of 3% minoxidil versus combined 3% minoxidil / 0.1% finasteride in male pattern hair loss: a randomized, double-blind, comparative study.

    Science.gov (United States)

    Tanglertsampan, Chuchai

    2012-10-01

    Topical minoxidil and oral finasteride have been used to treat men with androgenetic alopecia (AGA). There are concerns about side effects of oral finasteride especially erectile dysfunction. To compare the efficacy and safety of the 24 weeks application of 3% minoxidil lotion (MNX) versus combined 3% minoxidil and 0.1% finasteride lotion (MFX) in men with AGA. Forty men with AGA were randomized treated with MNX or MFX. Efficacy was evaluated by hair counts and global photographic assessment. Safety assessment was performed by history and physical examination. At week 24, hair counts were increased from baseline in both groups. However paired t-test revealed statistical difference only in MFX group (p = 0.044). Unpaired t-test revealed no statistical difference between two groups with respect to change of hair counts at 24 weeks from baseline (p = 0.503). MFX showed significantly higher efficacy than MNX by global photographic assessment (p = 0.003). There was no significant difference in side effects between both groups. Although change of hair counts was not statistically different between two groups, global photographic assessment showed significantly greater improvement in the MFX group than the MNX group. There was no sexual side effect. MFX may be a safe and effective treatment option.

  5. A randomised double-blinded crossover study comparing pain during anaesthetising the eyelids in upper blepharoplasty : First versus second eyelid and lidocaine versus prilocaine

    NARCIS (Netherlands)

    Pool, Shariselle M. W.; Struys, Michel M. R. F.; van der Lei, Berend

    Aim: The aim of this study was to investigate whether infiltration of the upper eyelid skin is less painful with prilocaine than with lidocaine. Methods: In 40 consecutive patients scheduled for bilateral upper blepharoplasty, one upper eyelid was anaesthetised with lidocaine with epinephrine and

  6. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study.

    Science.gov (United States)

    Park, Won; Hrycaj, Pawel; Jeka, Slawomir; Kovalenko, Volodymyr; Lysenko, Grygorii; Miranda, Pedro; Mikazane, Helena; Gutierrez-Ureña, Sergio; Lim, MieJin; Lee, Yeon-Ah; Lee, Sang Joon; Kim, HoUng; Yoo, Dae Hyun; Braun, Jürgen

    2013-10-01

    To compare the pharmacokinetics (PK), safety and efficacy of innovator infliximab (INX) and CT-P13, a biosimilar to INX, in patients with active ankylosing spondylitis (AS). Phase 1 randomised, double-blind, multicentre, multinational, parallel-group study. Patients were randomised to receive 5 mg/kg of CT-P13 (n=125) or INX (n=125). Primary endpoints were area under the concentration-time curve (AUC) at steady state and observed maximum steady state serum concentration (Cmax,ss) between weeks 22 and 30. Additional PK, efficacy endpoints, including 20% and 40% improvement response according to Assessment in Ankylosing Spondylitis International Working Group criteria (ASAS20 and ASAS40), and safety outcomes were also assessed. Geometric mean AUC was 32 765.8 μgh/ml for CT-P13 and 31 359.3 μgh/ml for INX. Geometric mean Cmax,ss was 147.0 μg/ml for CT-P13 and 144.8 μg/ml for INX. The ratio of geometric means was 104.5% (90% CI 94% to 116%) for AUC and 101.5% (90% CI 95% to 109%) for Cmax,ss. ASAS20 and ASAS40 responses at week 30 were 70.5% and 51.8% for CT-P13 and 72.4% and 47.4% for INX, respectively. In the CT-P13 and INX groups more than one adverse event occurred in 64.8% and 63.9% of patients, infusion reactions occurred in 3.9% and 4.9%, active tuberculosis occurred in 1.6% and 0.8%, and 27.4% and 22.5% of patients tested positive for anti-drug antibodies, respectively. The PK profiles of CT-P13 and INX were equivalent in patients with active AS. CT-P13 was well tolerated, with an efficacy and safety profile comparable to that of INX up to week 30.

  7. Study Protocol for a Randomized Double Blind, Treatment Control Trial Comparing the Efficacy of a Micronutrient Formula to a Single Vitamin Supplement in the Treatment of Premenstrual Syndrome.

    Science.gov (United States)

    Retallick-Brown, Hannah; Rucklidge, Julia; Blampied, Neville

    2016-12-07

    Background: The recent addition of Premenstrual Dysphoric Disorder (PMDD) to the Diagnostic and Statistical Manual (5th ed.) has highlighted the seriousness of this disorder. Many alternatives to psychoactive medication in the form of vitamins, minerals, and plant extracts have been trialled by women seeking a natural treatment approach. We plan to explore whether a well validated micronutrient formula, EMPowerplus Advanced, can outperform a recognized single nutrient treatment, vitamin B6, for the treatment of Premenstrual Syndrome (PMS). Methods: This will be a randomized treatment control study. Eighty women will be recruited and assigned to one of two treatment groups; EMPowerplus Advanced or vitamin B6. Baseline daily data will be collected for an initial two cycles, followed by three months of active treatment. A natural follow up will take place three cycles post treatment. Results: The primary outcome measure will be PMS change scores as based on results from the Daily Record of Severity of Problems (DRSP). The number of treatment responders for each of the two groups will yield a comparison score between the two treatments, with participants deemed as a responder if they show a total PMS score improvement of 50% from their baseline scores on the DRSP. Conclusion: If a micronutrient formula proves more effective for treating PMS, not only does it give women suffering from the condition a viable treatment option, but it may also suggest one cause of PMS; that is insufficient minerals and vitamins.

  8. Analysis of incomplete excisions of basal-cell carcinomas after breadloaf microscopy compared with 3D-microscopy: a prospective randomized and blinded study.

    Science.gov (United States)

    Boehringer, Alexandra; Adam, Patrick; Schnabl, Saskia; Häfner, Hans-Martin; Breuninger, Helmut

    2015-08-01

    Basal-cell carcinomas may show irregular, asymmetric subclinical growth. This study analyzed the efficacy of 'breadloaf' microscopy (serial sectioning) and three-dimensional (3D) microscopy in detecting positive tumor margins. Two hundred eighty-three (283) tumors (51.2%) were put into the breadloaf microscopy group; 270 tumors (48.8%) into the 3D microscopy group. The position of any detected tumor outgrowths was identified in clock face fashion. The time required for cutting and embedding the specimens and the examination of the microscopic slides was measured. Patient/tumor characteristics and surgical margins did not differ significantly. Tumor outgrowths at the excision margin were found in 62 of 283 cases (21.9%) in the breadloaf microscopy group and in 115 of 270 cases (42.6%) in the 3D microscopy group, constituting a highly significant difference (p < 0.001). This difference held true with incomplete excision of fibrosing (infiltrative/sclerosing/morpheaform) tumors [32.9% in the breadloaf microscopy group and 57.5% in the 3D microscopy group (p = 0.003)] and also with solid (nodular) tumors [16.1 and 34.2%, respectively (p < 0.001)]. The mean overall examination time required showed no important difference. In summary, for detection of tumor outgrowths, 3D microscopy has almost twice the sensitivity of breadloaf microscopy, particularly in the situation of aggressive/infiltrative carcinomas. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  9. Equivalence of a single dose (1200 mg) compared to a three-time a day dose (400 mg) of chondroitin 4&6 sulfate in patients with knee osteoarthritis. Results of a randomized double blind placebo controlled study.

    Science.gov (United States)

    Zegels, B; Crozes, P; Uebelhart, D; Bruyère, O; Reginster, J Y

    2013-01-01

    Evaluation of the efficacy and safety of a single oral dose of a 1200 mg sachet of chondroitin 4&6 sulfate (CS 1200) vs three daily capsules of chondroitin 4&6 sulfate 400 mg (CS 3*400) (equivalence study) and vs placebo (superiority study) during 3 months, in patients with knee osteoarthritis (OA). Comparative, double-blind, randomized, multicenter study, including 353 patients of both genders over 45 years with knee OA. Minimum inclusion criteria were a Lequesne index (LI) ≥ 7 and pain ≥ 40 mm on a visual analogue scale (VAS). LI and VAS were assessed at baseline and after 1-3 months. Equivalence between CS was tested using the per-protocol procedure and superiority of CS vs placebo was tested using an intent-to-treat procedure. After 3 months of follow-up, no significant difference was demonstrated between the oral daily single dose of CS 1200 formulation and the three daily capsules of CS 400. Patients treated with CS 1200 or CS 3*400 were significantly improved compared to placebo after 3 months of follow-up in terms of LI (security and tolerability was observed between the three groups. This study suggests that a daily administration of an oral sachet of 1200 mg of chondroitin 4&6 sulfate allows a significant clinical improvement compared to a placebo, and a similar improvement when compared to a regimen of three daily capsules of 400 mg of the same active ingredient. Copyright © 2012 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  10. Adjunctive α-lipoic acid reduces weight gain compared with placebo at 12 weeks in schizophrenic patients treated with atypical antipsychotics: a double-blind randomized placebo-controlled study.

    Science.gov (United States)

    Kim, Nam Wook; Song, Yul-Mai; Kim, Eosu; Cho, Hyun-Sang; Cheon, Keun-Ah; Kim, Su Jin; Park, Jin Young

    2016-09-01

    α-Lipoic acid (ALA) has been reported to be effective in reducing body weight in rodents and obese patients. Our previous open trial showed that ALA may play a role in reducing weight gain in patients with schizophrenia on atypical antipsychotics. The present study evaluated the efficacy of ALA in reducing weight and BMI in patients with schizophrenia who had experienced significant weight gain since taking atypical antipsychotics. In a 12-week, double-blind randomized placebo-controlled study, 22 overweight and clinically stable patients with schizophrenia were randomly assigned to receive ALA or placebo. ALA was administered at 600-1800 mg, as tolerated. Weight, BMI, abdomen fat area measured by computed tomography, and metabolic values were determined. Adverse effects were also assessed to examine safety. Overall, 15 patients completed 12 weeks of treatment. There was significant weight loss and decreased visceral fat levels in the ALA group compared with the placebo group. There were no instances of psychopathologic aggravation or severe ALA-associated adverse effects. ALA was effective in reducing weight and abdominal obesity in patients with schizophrenia who had experienced significant weight gain since beginning an atypical antipsychotic regimen. Moreover, ALA was well tolerated throughout this study. ALA might play an important role as an adjunctive treatment in decreasing obesity in patients who take atypical antipsychotics.

  11. Immunogenicity and safety of the new reduced-dose tetanus-diphtheria vaccine in healthy Korean adolescents: A comparative active control, double-blind, randomized, multicenter phase III study.

    Science.gov (United States)

    Han, Seung Beom; Rhim, Jung-Woo; Shin, Hye Jo; Kim, Sang Yong; Kim, Jong-Hyun; Kim, Hyun-Hee; Lee, Kyung-Yil; Kim, Hwang Min; Choi, Young Youn; Ma, Sang Hyuk; Kim, Chun Soo; Kim, Dong Ho; Ahn, Dong Ho; Kang, Jin Han

    2017-04-01

    A new reduced-dose tetanus-diphtheria (Td) vaccine was developed in Korea, and phase I and II clinical trials were successfully undertaken. We conducted this double-blind, randomized, multicenter phase III clinical trial to assess the immunogenicity and safety of the new Td vaccine. Healthy adolescents 11-12 years of age were enrolled and randomized to receive the new Td vaccine (study group) or a commercially available Td vaccine (control group). Blood samples were collected prior to and 4 weeks after the vaccination. Between the study and control groups, seroprotection rate, booster response, and geometric mean titer of antibodies against diphtheria and tetanus toxoids were compared after the vaccination. All solicited and unsolicited adverse events and serious adverse events during the 6-week study period were monitored. A total of 164 adolescents received vaccination, and 156 of them were evaluated to assess immunogenicity. The seroprotection rate and geometric mean titer for antibodies against diphtheria were significantly higher in the study group, whereas those against tetanus were significantly higher in the control group. However, all seroprotection rates against diphtheria and tetanus in the study and control groups were high: 100% against diphtheria and tetanus in the study group, and 98.7% against diphtheria and 100% against tetanus in the control group. No significant differences in the frequency of solicited and unsolicited adverse events were observed between the two vaccine groups. The new Td vaccine is highly immunogenic and safe, and this new Td vaccine can be effectively used for preventing diphtheria and tetanus. Copyright © 2015. Published by Elsevier B.V.

  12. Color-Blindness Study: Color Discrimination on the TICCIT System.

    Science.gov (United States)

    Asay, Calvin S.; Schneider, Edward W.

    The question studied whether the specific seven TICCIT system colors used within color coding schemes can be a source of confusion, or not seen at all, by the color-blind segment of target populations. Subjects were 11 color-blind and three normally sighted students at Brigham Young University. After a preliminary training exercise to acquaint the…

  13. A randomized, double-blind, multicenter, parallel group study to compare relative efficacies of the topical gels 3% erythromycin/5% benzoyl peroxide and 0.025% tretinoin/erythromycin 4% in the treatment of moderate acne vulgaris of the face.

    Science.gov (United States)

    Gupta, Aditya K; Lynde, Charles W; Kunynetz, Rod A W; Amin, Smita; Choi, Ken; Goldstein, Eric

    2003-01-01

    Combination treatments for acne vulgaris, such as Benzamycin (3% erythromycin/5% benzoyl peroxide) and Stievamycin (0.025% tretinoin/erythromycin 4%), reduce bacterial growth, which contributes to the inflammatory lesions typical of adolescent acne, and also decrease the epidermal cell compaction which may form the characteristic noninflammatory comedone. Both agents contain erythromycin to reduce the growth of Propionibacterium acnes in skin. Benzoyl peroxide has antibiotic activity as well as anticomedogenic properties. Tretinoin may increase the turnover of epidermal cells and loosen the cells compacted to form comedones. A combination preparation containing the two antibiotics may reduce the development of resistance; the combination preparation containing tretinoin and erythromycin will have an antibiotic effect as well as acting on differentiation. This multicenter, randomized, double-blind, parallel group study compared the effectiveness of 3% erythromycin/5% benzoyl peroxide and 0.025% tretinoin/erythromycin 4%, each applied twice daily in patients with moderate acne vulgaris. Overall physician and patient ratings of severity of acne symptoms were performed at baseline and at weeks 2, 4, 8, and 12. At baseline the two treatment groups had similar disease severity. The number of papules, pustules, and comedones was reduced in both treatment groups at week 12, and the reductions were not significantly different between the two comparators. Global physician rating of improvement was significantly higher in the 3% erythromycin/5% benzoyl peroxide group compared with the 0.025% tretinoin/erythromycin 4% group; however, there was no significant difference in global patient ratings between the two treatment groups. An aggregate score was produced, for both physician rating and patient rating, by adding up individual symptom severity ratings. Compared with 0.025% tretinoin/erythromycin 4%, 3% erythromycin/5% benzoyl peroxide provided significantly greater reduction

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

    Science.gov (United States)

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

    2017-07-01

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

  15. A randomized, double-blind, comparative study to assess the safety and efficacy of topical retapamulin ointment 1% versus oral linezolid in the treatment of secondarily infected traumatic lesions and impetigo due to methicillin-resistant Staphylococcus aureus.

    Science.gov (United States)

    Tanus, Tonny; Scangarella-Oman, Nicole E; Dalessandro, Marybeth; Li, Gang; Breton, John J; Tomayko, John F

    2014-12-01

    To evaluate the clinical and bacteriological efficacy of topical retapamulin ointment 1% versus oral linezolid in the treatment of patients with secondarily infected traumatic lesions (SITLs; excluding abscesses) or impetigo due to methicillin-resistant Staphylococcus aureus (MRSA). A randomized, double-blind, double-dummy, multicenter, comparative study (NCT00852540). Patients recruited from 36 study centers in the United States. Patients 2 months or older with SITL (including secondarily infected lacerations or sutured wounds) or impetigo (bullous and nonbullous) suitable for treatment with a topical antibiotic, with a total Skin Infection Rating Scale score of 8 or greater, including a pus/exudate score of 3 or greater. Patients received retapamulin ointment 1% (plus oral placebo), twice daily for 5 days or oral linezolid (plus placebo ointment) 2 or 3 times daily for 10 days. Primary end point: clinical response (success/failure) at follow-up in patients with MRSA at baseline (per-protocol population). Secondary efficacy end points: clinical and microbiologic response and outcome at follow-up and end of therapy; therapeutic response at follow-up. The majority of patients had SITL (70.4% [188/267] and 66.4% [91/137] in the retapamulin and linezolid groups, respectively; intent-to-treat clinical population). Clinical success rate at follow-up was significantly lower in the retapamulin versus the linezolid group (63.9% [39/61] vs 90.6% [29/32], respectively; difference in success rate -26.7%; 95% CI, -45.7 to -7.7). Clinical success rate at follow-up in the per-protocol MRSA population was significantly lower in the retapamulin versus the linezolid group. It could not be determined whether this was related to study design, bacterial virulence, or retapamulin activity.

  16. The association of the effect of lithium in the maintenance treatment of bipolar disorder with lithium plasma levels : a post hoc analysis of a double-blind study comparing switching to lithium or placebo in patients who responded to quetiapine (Trial 144)

    NARCIS (Netherlands)

    Nolen, Willem A.; Weisler, Richard H.

    Nolen WA, Weisler RH. The association of the effect of lithium in the maintenance treatment of bipolar disorder with lithium plasma levels: a post hoc analysis of a double-blind study comparing switching to lithium or placebo in patients who responded to quetiapine (Trial 144). Bipolar Disord 2012:

  17. Impact of the cosmetic mouthwash “Jack Pro Spülung plus” (“rheodol-Spülung plus” on the oral cavity flora, tested in a monocentric, controlled, randomized, blind, cross-over comparative study

    Directory of Open Access Journals (Sweden)

    Göhring, Jana

    2014-03-01

    Full Text Available [english] Aim: Jack Pro Spülung Plus (also available as “rheodol-Spülung plus” is recommended to mechanically maintain oral hygiene as part of an overall oral hygiene concept. Because Jack Pro Spülung Plus contains the active agents polihexanide and tosylchloramide sodium in concentrations below microbicidal efficacy, this study tested the hypothesis that the combination of mechanical rinsing and bacteriostatic effect surpasses the effect of mechanical rinsing alone.Method: The study was performed with 30 volunteers as a monocentric, controlled, randomized, blind, cross-over comparative study. The efficacy of the test product (active agents polihexanide 0.02–0.03% and tosylchloramide sodium 0.004–0.006% was compared to an aqueous solution of polihexanide (0.02–0.03% and to Ringer solution as negative control. The efficacy was measured as the reduction of colony forming units (cfu on buccal mucosa after aerobic and anaerobic cultivation. After determination of pre-values, the volunteers performed mouthrinsing for 30 sec with each of the 3 tested solutions. After 1, 10 and 60 minutes, cfu numbers were determined again. The reduction factor was calculated as the difference between log of the measured cfu before and after mouthrinsing with the test solution. The sampling was performed using a template with a smear area of 1 x 1 cm. Results: Using Ringer solution led to a slight mechanically-induced reduction of cfu in the oral cavity 1 min after rinsing the mouth cavity with the solution. After 10 min and 60 min, no influence on the cfu number could be detected. Using Jack pro Spülung Plus led to a bacteriostatic effect up to 60 min after mouthrinsing; 10 min and 60 min after rinsing the efficacy of Ringer solution was also significantly surpassed. The aqueous solution of polihexanide was less effective than Jack pro Spülung Plus after 10 and 60 min. Conclusion: Based on these observations, we conclude that Jack pro Spülung Plus is

  18. Laser Acupuncture at Large Intestine 4 Compared with Oral Glucose Administration for Pain Prevention in Healthy Term Neonates Undergoing Routine Heel Lance: Study Protocol for an Observer-Blinded, Randomised Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Jasmin Stadler

    2018-01-01

    Full Text Available Background. Nonpharmacological strategies have actually become more important in neonatal pain management during routinely applied minor painful procedures. However, commonly used nonpharmacological strategies are inferior to orally administered sweet solutions. Therefore, we will compare laser acupuncture, as a recent nonpharmacological method, with the standard care of oral glucose solution for pain prevention. Methods. Ninety-five healthy term neonates will be allocated into one of two groups. Before routine heel lance for metabolic screening, one group will receive laser acupuncture at acupuncture point Large Intestine 4 (LI 4 bilaterally for 60 seconds per point (acupuncture group and the other will receive the standard care with orally administered glucose solution (glucose group. The complete procedure of blood sampling will be recorded on video, excluding the intervention before heel lance. A paediatric nurse, blinded with respect to the allocation, will evaluate these video recordings and determine the Premature Infant Pain Profile (PIPP for each neonate. Primary outcome will be the mean difference in PIPP scores between groups. Discussion. This observer-blinded randomised controlled trial has been designed to explore potential advantages of laser acupuncture in the management of neonatal pain because more data are required to provide information about its efficacy and safety. Trial Registration. This trial is registered with DRKS00010122.

  19. Laser Acupuncture at Large Intestine 4 Compared with Oral Glucose Administration for Pain Prevention in Healthy Term Neonates Undergoing Routine Heel Lance: Study Protocol for an Observer-Blinded, Randomised Controlled Clinical Trial.

    Science.gov (United States)

    Stadler, Jasmin; Avian, Alexander; Posch, Katrin; Urlesberger, Berndt; Raith, Wolfgang

    2018-01-01

    Nonpharmacological strategies have actually become more important in neonatal pain management during routinely applied minor painful procedures. However, commonly used nonpharmacological strategies are inferior to orally administered sweet solutions. Therefore, we will compare laser acupuncture, as a recent nonpharmacological method, with the standard care of oral glucose solution for pain prevention. Ninety-five healthy term neonates will be allocated into one of two groups. Before routine heel lance for metabolic screening, one group will receive laser acupuncture at acupuncture point Large Intestine 4 (LI 4) bilaterally for 60 seconds per point (acupuncture group) and the other will receive the standard care with orally administered glucose solution (glucose group). The complete procedure of blood sampling will be recorded on video, excluding the intervention before heel lance. A paediatric nurse, blinded with respect to the allocation, will evaluate these video recordings and determine the Premature Infant Pain Profile (PIPP) for each neonate. Primary outcome will be the mean difference in PIPP scores between groups. This observer-blinded randomised controlled trial has been designed to explore potential advantages of laser acupuncture in the management of neonatal pain because more data are required to provide information about its efficacy and safety. This trial is registered with DRKS00010122.

  20. Localização especial de estímulos sonoros em indivíduos cegos congênitos: estudo comparativo da posição tridimensional da cabeça em adultos cegos congênitos e indivíduos videntes Spatial localization of sounds in blind individuals: comparative study of three dimensional position of the head in blind and non blind adults

    Directory of Open Access Journals (Sweden)

    Juliana Gonçalves da Silva Gerente

    2008-04-01

    Full Text Available A capacidade para localizar objetos fixos ou em movimento no espaço tridimensional depende da função visual. No indivíduo cego, as modalidades sensoriais remanescentes, nomeadamente a audição, poderiam compensar a visão na localização espacial. O objetivo deste estudo foi analisar o papel da audição no mecanismo de localização espacial por meio da habilidade de orientar de forma precisa a cabeça face à fonte sonora. Cinco adultos cegos congênitos foram comparados com cinco sujeitos videntes vendados. A tarefa consistiu na orientação da cabeça ao estímulo sonoro, emitido por sete fontes diferentes, com localização fixa. A posição tridimensional da cabeça e tronco foi registrada por um sistema de varredura eletromagnético (Flock of Birds System. Para cada som produzido foi calculado o "erro de localização". Esta medida correspondeu à diferença entre o registro da posição obtido durante o teste e durante uma posição de controle. Os resultados revelaram que nos indivíduos cegos congênitos a magnitude de erro de localização dos estímulos auditivos foi superior aos indivíduos videntes. Conclui-se que a representação mental formada com base na visão constitui um dos pré-requisitos para um bom desempenho nas tarefas espaciais.The ability to locate stationary or moving objects in space depends on visual function. It is thought that for blind individuals, the remaining sensory modalities, in particular hearing, will compensate for the absence of vision in spatial localization. This study aimed to analyze the role of hearing on the spatial localization mechanism by looking at the ability to accurately direct the head to the source of sound. Five congenitally blind adults were compared to five sighted people who wore blindfolds. The task consisted of turning the head toward the sound stimulus, coming from seven different fixed point sources. The three dimensional position of the head and trunk was registered by an

  1. Prospective randomized double-blind multicentre phase II study comparing gemcitabine and cisplatin plus sorafenib chemotherapy with gemcitabine and cisplatin plus placebo in locally advanced and/or metastasized urothelial cancer: SUSE (AUO-AB 31/05).

    Science.gov (United States)

    Krege, Susanne; Rexer, Heidrun; vom Dorp, Frank; de Geeter, Patrick; Klotz, Theodor; Retz, Margitte; Heidenreich, Axel; Kühn, Michael; Kamradt, Joern; Feyerabend, Susan; Wülfing, Christian; Zastrow, Stefan; Albers, Peter; Hakenberg, Oliver; Roigas, Jan; Fenner, Martin; Heinzer, Hans; Schrader, Mark

    2014-03-01

    To evaluate the efficacy and safety of gemcitabine and cisplatin in combination with sorafenib, a tyrosine-kinase inhibitor, compared with chemotherapy alone as first-line treatment in advanced urothelial cancer. The study was a randomized phase II trial. Its primary aim was to show an improvement in progression-free survival (PFS) of 4.5 months by adding sorafenib to conventional chemotherapy. Secondary objectives were objective response rate (ORR), overall survival (OS) and toxicity. The patients included in the trial had histologically confirmed locally advanced and/or metastatic urothelial cancer of the bladder or upper urinary tract. Chemotherapy with gemcitabine (1250 mg/qm on days 1 and 8) and cisplatin (70 mg/qm on day 1) repeated every 21 days, was administered to all patients in a double-blind randomization of additional sorafenib (400 mg twice daily) vs placebo (two tablets twice daily) on days 3-21. Treatment continued until progression or unacceptable toxicity, the maximum number of cycles was limited to eight. The response assessment was repeated after every two cycles. Between October 2006 and October 2010, 98 of 132 planned patients were recruited. Nine patients were ineligible. The final analysis included 40 patients in the sorafenib and 49 patients in the placebo arm. There were no significant differences between the two arms concerning ORR (sorafenib: complete response [CR] 12.5%, partial response [PR] 40%; placebo: CR 12%, PR 35%), median PFS (sorafenib: 6.3 months, placebo: 6.1 months) or OS (sorafenib: 11.3 months, placebo: 10.6 months). Toxicity was moderately higher in the sorafenib arm. Diarrrhoea occurred significantly more often in the sorafenib arm and hand-foot syndrome occurred only in the sorafenib arm. The study was closed prematurely because of slow recruitment. Although the addition of sorafenib to standard chemotherapy showed acceptable toxicity, the trial failed to show a 4.5 months improvement in PFS. © 2013 The Authors

  2. Protective effect of budesonide/formoterol compared with formoterol, salbutamol and placebo on repeated provocations with inhaled AMP in patients with asthma: a randomised, double-blind, cross-over study

    Directory of Open Access Journals (Sweden)

    van der Woude Hanneke J

    2010-05-01

    Full Text Available Abstract Background The budesonide/formoterol combination is successfully used for fast relief of asthma symptoms in addition to its use as maintenance therapy. The temporarily increased corticosteroid dose during increasing inhaler use for symptom relief is likely to suppress any temporary increase in airway inflammation and may mitigate or prevent asthma exacerbations. The relative contribution of the budesonide and formoterol components to the improved asthma control is unclear. Methods The acute protective effect of inhaled budesonide was tested in a model of temporarily increased airway inflammation with repeated indirect airway challenges, mimicking an acute asthma exacerbation. A randomised, double-blind, cross-over study design was used. Asthmatic patients (n = 17, mean FEV1 95% of predicted who previously demonstrated a ≥30% fall in forced expiratory volume in 1 second (FEV1 after inhaling adenosine 5'-monophosphate (AMP, were challenged on four consecutive test days, with the same dose of AMP (at 09:00, 12:00 and 16:00 hours. Within 1 minute of the maximal AMP-induced bronchoconstriction at 09:00 hours, the patients inhaled one dose of either budesonide/formoterol (160/4.5 μg, formoterol (4.5 μg, salbutamol (2 × 100 μg or placebo. The protective effects of the randomised treatments were assessed by serial lung function measurements over the test day. Results In the AMP provocations at 3 and 7 hours after inhalation, the budesonide/formoterol combination provided a greater protective effect against AMP-induced bronchoconstriction compared with formoterol alone, salbutamol and placebo. In addition all three active treatments significantly increased FEV1 within 3 minutes of administration, at a time when inhaled AMP had induced the 30% fall in FEV1. Conclusions A single dose of budesonide/formoterol provided a greater protective effect against inhaled AMP-induced bronchoconstriction than formoterol alone, both at 3 and at 7 hours

  3. Radiation Protection, double-blind studies with radiopharmaceuticals

    International Nuclear Information System (INIS)

    Pujadas, M. C.; Camacho, C.; Guasp, M.; Villaescusa, J. I.

    2009-01-01

    In a double-blind randomized controlled clinical trial (RCT) subjects and researchers do not know the assignment to treatment groups to ovoid the appearance of subjective biases of information. The employment of radiopharmaceuticals in double-blind RCTs raises a dilemma from the point ov view of the radiological protection. On the one hand, the obligation to act in cases of contamination and/or risk of irradiation exists, but on the other hand the duty of keeping the blind study also exists. In this paper some of the possible problems that arise when conducting a double-blind RCT with radiopharmaceuticals from the point of view of the radiological protection are presented. We comment our experience with the radiopharmaceutical Alpharadin and, in addition, we propose useful recommendations based on the randomness of the decontamination process. (Author) 7 refs.

  4. Reducing dosing frequency of carbidopa/levodopa: double-blind crossover study comparing twice-daily bilayer formulation of carbidopa/levodopa (IPX054) versus 4 daily doses of standard carbidopa/levodopa in stable Parkinson disease patients.

    Science.gov (United States)

    Hinson, Vanessa K; Goetz, Christopher G; Leurgans, Sue; Fan, Wenqing; Nguyen, Tiffany; Hsu, Ann

    2009-01-01

    We compared IPX054, a bilayer tablet of immediate- and extended-release carbidopa/levodopa (CD/LD) given twice daily to standard CD/LD given 4 times daily in patients with stable Parkinson disease (PD). Twelve PD patients with no or mild fluctuations on CD/LD 25/100 mg 4 times daily were randomized to a double-blind crossover comparison with IPX054 (50/200 mg) twice daily. At the end of each 2-week treatment, patients were video recorded while performing a modified Unified Parkinson's Disease Rating Scale motor examination and Rush Dyskinesia Rating Scale at 30-minute intervals over 8.5 hours. The primary outcome measure was the number of videotape epochs rated as "ON" without troublesome dyskinesia by a blinded observer (Wilcoxon signed rank tests). The 9 men and 3 women had a mean age of 69 years and mean PD duration of 6 years. IPX054 and CD/LD showed no significant differences in the primary outcome measure (mean number of video epochs rated as ON without troublesome dyskinesia; P = 0.14). The mean time to ON was improved with IPX054 (P = 0.014), and the mean modified Unified Parkinson's Disease Rating Scale scores slightly favored IPX054 (14.4 vs 16.9; P = 0.052). Mean Rush Dyskinesia Rating Scale scores were not significantly different between IPX054 and CD/LD (0.45 vs 0.69; P = 0.25). No patient developed troublesome dyskinesias. In stable PD patients, no difference was detected between twice-daily treatment with IPX054 and CD/LD given 4 times daily. In this group, substitution with IPX054 reduced dosing frequency while maintaining CD/LD efficacy. In clinical practice, this ease of administration may offer improved treatment compliance.

  5. Randomized, double-blind, crossover study comparing DFN-11 injection (3 mg subcutaneous sumatriptan) with 6 mg subcutaneous sumatriptan for the treatment of rapidly-escalating attacks of episodic migraine.

    Science.gov (United States)

    Cady, Roger K; Munjal, Sagar; Cady, Ryan J; Manley, Heather R; Brand-Schieber, Elimor

    2017-12-01

    A 6-mg dose of SC sumatriptan is the most efficacious and fast-acting acute treatment for migraine, but a 3-mg dose of SC sumatriptan may improve tolerability while maintaining efficacy. This randomized, double-blind, crossover study compared the efficacy and tolerability of 3 mg subcutaneous (SC) sumatriptan (DFN-11) with 6 mg SC sumatriptan in 20 adults with rapidly-escalating migraine attacks. Eligible subjects were randomized (1:1) to treat 1 attack with DFN-11 and matching placebo autoinjector consecutively or 2 DFN-11 autoinjectors consecutively and a second attack similarly but with the alternative dose (3 mg or 6 mg). The proportions of subjects who were pain-free at 60 min postdose, the primary endpoint, were similar following treatment with 3 mg SC sumatriptan and 6 mg SC sumatriptan (50% vs 52.6%, P  =  .87). The proportions of subjects experiencing pain relief (P  ≥  .48); reductions in migraine pain intensity (P  ≥  .78); and relief from nausea, photophobia, or phonophobia (P  ≥  .88) with 3 mg SC sumatriptan and 6 mg SC sumatriptan were similar, as were the mean scores for satisfaction with treatment (M  =  2.6 vs M  =  2.4, P  =  .81) and the mean number of rescue medications used (M  =  .11 vs M  =  .26, P  =  .32). The most common adverse events with the 3- and 6-mg doses were triptan sensations - paresthesia, neck pain, flushing, and involuntary muscle contractions of the neck - and the incidence of adverse events with both doses was similar (32 events total: 3 mg, n  =  14 [44%]; 6 mg, n  =  18 [56%], P  =  .60). Triptan sensations affected 4 subjects with the 6-mg dose only, 1 subject with the 3-mg dose only, and 7 subjects with both sumatriptan doses. Chest pain affected 2 subjects (10%) treated with the 6-mg dose and no subjects (0%) treated with the 3-mg dose of DFN-11. There were no serious adverse events. The 3-mg SC dose

  6. 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

  7. An investigator-blinded, randomized study to compare the efficacy of combined CBT for alcohol use disorders and social anxiety disorder versus CBT focused on alcohol alone in adults with comorbid disorders: the Combined Alcohol Social Phobia (CASP) trial protocol.

    Science.gov (United States)

    Baillie, Andrew J; Sannibale, Claudia; Stapinski, Lexine A; Teesson, Maree; Rapee, Ronald M; Haber, Paul S

    2013-07-30

    Alcohol use disorders and social anxiety disorder are common and disabling conditions that frequently co-exist. Although there are efficacious treatments for each disorder, only two randomized controlled trials of interventions for these combined problems have been published. We developed a new integrated treatment for comorbid Social Anxiety Disorder and Alcohol Use Disorder based on established Motivational Interviewing (MI) and Cognitive Behaviour Therapy (CBT) interventions for the separate disorders. Compared to established MI/CBT for alcohol use disorders this new intervention is hypothesised to lead to greater reductions in symptoms of social anxiety and alcohol use disorder and to produce greater improvements in quality of life. Higher levels of alcohol dependence will result in relatively poorer outcomes for the new integrated treatment. A randomised controlled trial comparing 9 sessions of individual integrated treatment for alcohol and social phobia with 9 sessions of treatment for alcohol use problems alone is proposed. Randomisation will be stratified for stable antidepressant use. Post treatment clinical assessments of alcohol consumption and diagnostic status at 3 and 6 month follow-up will be blind to allocation. The proposed trial addresses a serious gap in treatment evidence and could potentially define the appropriate treatment for a large proportion of adults affected by these problems. Australian New Zealand Clinical Trials Registry: ACTRN12608000228381.

  8. Ibrutinib combined with bendamustine and rituximab compared with placebo, bendamustine, and rituximab for previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma (HELIOS): a randomised, double-blind, phase 3 study.

    Science.gov (United States)

    Chanan-Khan, Asher; Cramer, Paula; Demirkan, Fatih; Fraser, Graeme; Silva, Rodrigo Santucci; Grosicki, Sebastian; Pristupa, Aleksander; Janssens, Ann; Mayer, Jiri; Bartlett, Nancy L; Dilhuydy, Marie-Sarah; Pylypenko, Halyna; Loscertales, Javier; Avigdor, Abraham; Rule, Simon; Villa, Diego; Samoilova, Olga; Panagiotidis, Panagiots; Goy, Andre; Mato, Anthony; Pavlovsky, Miguel A; Karlsson, Claes; Mahler, Michelle; Salman, Mariya; Sun, Steven; Phelps, Charles; Balasubramanian, Sriram; Howes, Angela; Hallek, Michael

    2016-02-01

    Most patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma relapse after initial therapy. Bendamustine plus rituximab is often used in the relapsed or refractory setting. We assessed the efficacy and safety of adding ibrutinib, an oral covalent inhibitor of Bruton's tyrosine kinase (BTK), to bendamustine plus rituximab in patients with previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma. The HELIOS trial was an international, double-blind, placebo-controlled, phase 3 study in adult patients (≥18 years of age) who had active chronic lymphocytic leukaemia or small lymphocytic lymphoma with measurable lymph node disease (>1·5 cm) by CT scan, and had relapsed or refractory disease following one or more previous lines of systemic therapy consisting of at least two cycles of a chemotherapy-containing regimen, an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and adequate bone marrow, liver, and kidney function. Patients with del(17p) were excluded because of known poor response to bendamustine plus rituximab. Patients who had received previous treatment with ibrutinib or other BTK inhibitors, refractory disease or relapse within 24 months with a previous bendamustine-containing regimen, or haemopoietic stem-cell transplant were also excluded. Patients were randomly assigned (1:1) by a web-based system to receive bendamustine plus rituximab given in cycles of 4 weeks' duration (bendamustine: 70 mg/m(2) intravenously on days 2-3 in cycle 1, and days 1-2 in cycles 2-6; rituximab: 375 mg/m(2) on day 1 of cycle 1, and 500 mg/m(2) on day 1 of cycles 2-6 for a maximum of six cycles) with either ibrutinib (420 mg daily orally) or placebo until disease progression or unacceptable toxicity. Patients were stratified according to whether they were refractory to purine analogues and by number of previous lines of therapy. The primary endpoint was independent review committee (IRC)-assessed progression

  9. Comparative Studies for What?

    Directory of Open Access Journals (Sweden)

    Pedro Guedes de Carvalho

    2017-12-01

    course (1948, the first, credit units, eligibility, number of year offer, type of graduation (from major to doctorate and professional. Concluding, the end of the sixties can be the mark of a well-established body of literature in comparative education and sports studies published in several scientific journals. What about the XXIst century? Is it still important to compare sports and education throughout the world? Only with qualitative methods? Mixed methods? We think so. That is why, after a certain decline and fuzzy goal definition in research motivations within ISCPES we decided to innovate and reorganize people from physical education and sports around this important theme of comparative studies. Important because we observe an increasing concern on the contradictions across different results in publications under the same subject. How can we infer? What about good research questions which get no statistically significant results? New times are coming, and we want to be on that frontline of this move as said by Elsevier “With RMR (results masked review articles, you don’t need to worry about what editors or reviewers might think about your results. As long as you have asked an important question and performed a rigorous study, your paper will be treated the same as any other. You do not need to have null results to submit an RMR article; there are many reasons why it can be helpful to have the results blinded at initial review”.https://www.elsevier.com/connect/reviewers-update/results-masked-review-peer-review-without-publication-bias. This is a very different and challenging time. Our future strategy will comprehend more cooperation between researchers, institutions and scientific societies as an instrument to leverage our understanding of physical activity and sports through different continents and countries and be useful for policy designs. Next 2018, on the occasion of the UE initiative Sofia – European Capital of Sport 2018 we - Bulgarian Comparative

  10. A Randomized Double-Blind Controlled Trial Comparing Davanloo Intensive Short-Term Dynamic Psychotherapy as Internet-Delivered Vs Treatment as Usual for Medically Unexplained Pain: A 6-Month Pilot Study.

    Science.gov (United States)

    Chavooshi, Behzad; Mohammadkhani, Parvaneh; Dolatshahi, Behrouz

    2016-01-01

    Research has shown that Intensive Short-Term Dynamic Psychotherapy (ISTDP) can effectively decrease pain intensity and improve quality of life in patients with medically unexplained pain. Understanding that not all patients with medically unexplained pain have access to in-person ISTDP, this study aims to investigate the efficacy of an Internet-delivered ISTDP for individuals with medically unexplained pain using Skype in comparison with treatment as usual. In this randomized controlled trial, 100 patients were randomly allocated into Internet-delivered ISTDP (n = 50) and treatment-as- usual (n = 50) groups. Treatment intervention consisted of 16 weekly, hour-long therapy sessions. The primary outcome was perceived pain assessed using the Numeric Pain Rating Scale. The secondary outcome included Depression Anxiety Stress Scale-21, Emotion Regulation Questionnaire, Mindful Attention Awareness Scale, and Quality-of-Life Inventory. Blind assessments were conducted at the baseline, posttreatment, and at a 6-month follow-up. In the intention-to-treat analysis, pain symptoms in the intervention group were significantly reduced (p Skype can significantly improve pain intensity and clinical symptoms of medically unexplained pain. Copyright © 2016 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.

  11. Efficacy and safety of ABP 980 compared with reference trastuzumab in women with HER2-positive early breast cancer (LILAC study): a randomised, double-blind, phase 3 trial.

    Science.gov (United States)

    von Minckwitz, Gunter; Colleoni, Marco; Kolberg, Hans-Christian; Morales, Serafin; Santi, Patricia; Tomasevic, Zorica; Zhang, Nan; Hanes, Vladimir

    2018-06-04

    ABP 980 (Amgen Inc, Thousand Oaks, CA, USA) is a biosimilar of trastuzumab, with analytical, functional, and pharmacokinetic similarities. We compared the clinical safety and efficacy of ABP 980 with that of trastuzumab in women with HER2-positive early breast cancer. We did a randomised, multicentre, double-blind, active-controlled equivalence trial at 97 study centres in 20 countries, mainly in Europe and South America. Eligible women were aged 18 years or older, had histologically confirmed HER2-positive invasive early breast cancer, an Eastern Cooperative Oncology Group performance status score of 0 or 1, and were planning to have surgical resection of the breast tumour with sentinel or axillary lymph node dissection and neoadjuvant chemotherapy. After four cycles of run-in anthracycline-based chemotherapy, patients were assigned 1:1 to receive ABP 980 or trastuzumab with a permuted block design (blocks of four) computer-generated randomisation schedule. Patients received neoadjuvant therapy with a loading dose (8 mg/kg) of ABP 980 or trastuzumab plus paclitaxel 175 mg/m 2 in a 90 min intravenous infusion, followed by three cycles of 6 mg/kg intravenous ABP 980 or trastuzumab plus paclitaxel 175 mg/m 2 every 3 weeks in 30 min intravenous infusions (or 80 mg/m 2 paclitaxel once per week for 12 cycles if that was the local standard of care). Randomisation was stratified by T stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographical region. Surgery was completed 3-7 weeks after the last dose of neoadjuvant treatment, after which adjuvant treatment with ABP 980 or trastuzumab was given every 3 weeks for up to 1 year after the first dose in the study. Patients had been randomly assigned at baseline to continue APB 980, continue trastuzumab, or switch from trastuzumab to APB 980 as their adjuvant treatment. The co-primary efficacy endpoints were risk difference and risk ratio (RR) of pathological complete response in breast

  12. Recognition Memory for Braille or Spoken Words: An fMRI study in Early Blind

    OpenAIRE

    Burton, Harold; Sinclair, Robert J.; Agato, Alvin

    2011-01-01

    We examined cortical activity in early blind during word recognition memory. Nine participants were blind at birth and one by 1.5 yrs. 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 la...

  13. Balneotherapy in fibromyalgia: a single blind randomized controlled clinical study.

    Science.gov (United States)

    Ozkurt, Seçil; Dönmez, Arif; Zeki Karagülle, M; Uzunoğlu, Emel; Turan, Mustafa; Erdoğan, Nergis

    2012-07-01

    We aimed to evaluate the effectiveness of balneotherapy in fibromyalgia management. Fifty women with fibromyalgia under pharmacological treatment were randomly assigned to either the balneotherapy (25) or the control (25) group. Four patients from the balneotherapy group and one patient from the control group left the study after randomization. The patients in the balneotherapy group (21) had 2 thermomineral water baths daily for 2 weeks in Tuzla Spa Center. The patients in the control group (24) continued to have their medical treatment and routine daily life. An investigator who was blinded to the study arms assessed the patients. All patients were assessed four times; at the beginning of the study, at the end of the 2nd week, the 1st month, and the 3rd month after balneotherapy. Outcome measures of the study were pain intensity, Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Inventory (BDI), patient's global assessment, investigator's global assessment, SF-36 scores, and tender point count. Balneotherapy was found to be superior at the end of the cure period in terms of pain intensity, FIQ, Beck Depression Inventory, patient's global assessment, investigator's global assessment scores, and tender point count as compared to the control group. The superiority of balneotherapy lasted up to the end of the 3rd month, except for the Beck Depression Inventory score and the investigator's global assessment score. Significant improvements were observed in PF, GH, and MH subscales of SF-36 during the study period in the balneotherapy group; however, no such improvement was observed in the control group. Balneotherapy was superior only in VT subscale at the end of therapy and at the end of the third month after the therapy as compared to the controls. It was concluded that balneotherapy provides beneficial effects in patients with fibromyalgia.

  14. Cure of Helicobacter pylori-positive active duodenal ulcer patients: a double-blind, multicentre, 12-month study comparing a two-week dual vs a one-week triple therapy. GISU (Interdisciplinary Group for Ulcer Study).

    Science.gov (United States)

    Di Mario, F; Battaglia, F; Dal Bò, N; Leandro, G; Benedetti, E; Bottona, E; Caroli, A; Costan-Biedo, F; De Bastiani, R; Germanà, B; Andrea Grassi, S; Madia, D; Marcon, V; Marin, R; Monica, F; Olivieri, P; Orzes, N; Pilotto, A; Ronzani, G; Saggioro, A; Tafner, G

    2000-03-01

    To compare a two-week dual therapy to a one-week triple therapy for the healing of duodenal ulcer and the eradication of the Helicobacter pylori infection. A total of 165 patients with active duodenal ulcer were enrolled in the study. At entry, endoscopy, clinical examination and laboratory tests were performed. Histology and the rapid urease test were used to diagnose Helicobacter pylori infection. Patients received either lansoprazole 30 mg plus amoxycillin 1 g bid for two weeks (two-week, dual therapy) or lansoprazole 30 mg plus amoxycillin 1 g plus tinidazole 500 mg bid for one week plus lansoprazole qd for an additional week (one-week, triple therapy). Two and twelve months after cessation of therapy, endoscopy and clinical assessments were repeated. Duodenal ulcer healing and Helicobacter pylori eradication were both significantly greater (pcure rate: 72.6%) than in the dual therapy group (healing: 77.3%; Helicobacter pylori cure rate: 33.3%). Ulcers healed more frequently in Helicobacter pyloricured than in Helicobacter pylori-not cured patients (94.9% vs. 77.2%; pulcer relapses were observed throughout follow-up: all were in Helicobacter pylori-not cured patients. Triple therapy was more effective than dual both in curing Helicobacter pylori infection and healing active duodenal ulcers. The speed of ulcer healing obtained after only 7 days of antibiotics and 14 days of proton pump inhibitors confirmed that longer periods of anti ulcer therapy were not necessary. Helicobacter pylori -not cured patients had more slowly healing ulcers which were more apt to relapse when left untreated.

  15. 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.

  16. An Exploration into Self Concept: A Comparative Analysis between the Adolescents Who Are Sighted and Blind in India

    Science.gov (United States)

    Halder, Santoshi; Datta, Poulomee

    2012-01-01

    The purpose of this study was to explore the self concept of adolescents who are sighted and blind with respect to gender in India. The sample was made up of 160 participants aged 15 to 18 years: of whom 100 were sighted and 60 were blind. The results of the t-tests illustrated that sighted male adolescents scored higher in the overall…

  17. 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...

  18. Five Blind Men and an Elephant: Comparing Aura Ozone Datasets and Sonde with Model Simulations

    Science.gov (United States)

    Tang, Q.; Prather, M. J.

    2011-12-01

    The four Earth Observing System (EOS) Aura satellite ozone measurements (HIRDLS, MLS, OMI, and TES) as well as the coincident WOUDC sonde are the five ``blind men'' touching the ``elephant'' (ozone). They all measure ozone (O3) in the upper troposphere and lower stratosphere (UT/LS) region, providing the great opportunity to study how the tropospheric ozone is influenced by the stratospheric source, an important tropospheric ozone budget term with large uncertainties and discrepancies across different models and methods. Based upon the 2-D autocorrelation for the tropospheric column ozone anomalies of the OMI swaths, we show that the stratosphere-troposphere exchange (STE) processes occur on the scale of a few hundred kilometers. Applying the high resolution (1o±1o±40-layer±0.5 hr) atmospheric chemistry transport model (CTM) as a transfer standard, we compare the noncoincident Aura level 2 swath datasets with the exact matching simulations of each measurement to investigate the consistency of different instruments as well as evaluate the accuracy of modeled ozone. Different signs of the CTM biases against HIRDLS, MLS, and TES are found from tropics to northern hemisphere (NH) mid-latitudes in July 2005 at 215 hPa and over tropics at 147 hPa for July 2005 and January 2006, suggesting inconsistency across these Aura datasets. On the other hand, the CTM has great positive biases against satellite observations in the lower stratosphere of winter time southern hemisphere (SH) mid-latitudes, which is probably attributed to the problems in the stratospheric circulation of the driving met-fields. The model's ability of reproducing STE-related processes, such as tropospheric folds (TFs), is confirmed by the comparisons with WOUDC sonde. We found eight cases in year 2005 with all the four Aura measurements available and folding structures in the coincident sonde profile. The case studies indicate that all the four Aura instruments demonstrate some skills in catching the

  19. A Study of Color Transformation on Website Images for the Color Blind

    OpenAIRE

    Siew-Li Ching; Maziani Sabudin

    2010-01-01

    In this paper, we study on color transformation method on website images for the color blind. The most common category of color blindness is red-green color blindness which is viewed as beige color. By transforming the colors of the images, the color blind can improve their color visibility. They can have a better view when browsing through the websites. To transform colors on the website images, we study on two algorithms which are the conversion techniques from RGB colo...

  20. 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

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

    Science.gov (United States)

    Sathyapalan, Thozhukat; Thatcher, Natalie J; Hammersley, Richard; Rigby, Alan S; Courts, Fraser L; Pechlivanis, Alexandros; Gooderham, Nigel J; Holmes, Elaine; le Roux, Carel W; Atkin, Stephen L

    2015-01-01

    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 acute ingestion of

  2. Comparison of a GPS needle-tracking system, multiplanar imaging and 2D imaging for real-time ultrasound-guided epidural anaesthesia: A randomized, comparative, observer-blinded study on phantoms.

    Science.gov (United States)

    Menacé, Cécilia; Choquet, Olivier; Abbal, Bertrand; Bringuier, Sophie; Capdevila, Xavier

    2017-04-01

    The real-time ultrasound-guided paramedian sagittal oblique approach for neuraxial blockade is technically demanding. Innovative technologies have been developed to improve nerve identification and the accuracy of needle placement. The aim of this study was to evaluate three types of ultrasound scans during ultrasound-guided epidural lumbar punctures in a spine phantom. Eleven sets of 20 ultrasound-guided epidural punctures were performed with 2D, GPS, and multiplanar ultrasound machines (660 punctures) on a spine phantom using an in-plane approach. For all punctures, execution time, number of attempts, bone contacts, and needle redirections were noted by an independent physician. Operator comfort and visibility of the needle (tip and shaft) were measured using a numerical scale. The use of GPS significantly decreased the number of punctures, needle repositionings, and bone contacts. Comfort of the physician was also significantly improved with the GPS system compared with the 2D and multiplanar systems. With the multiplanar system, the procedure was not facilitated and execution time was longer compared with 2D imaging after Bonferroni correction but interaction between the type of ultrasound system and mean execution time was not significant in a linear mixed model. There were no significant differences regarding needle tip and shaft visibility between the systems. Multiplanar and GPS needle-tracking systems do not reduce execution time compared with 2D imaging using a real-time ultrasound-guided paramedian sagittal oblique approach in spine phantoms. The GPS needle-tracking system can improve performance in terms of operator comfort, the number of attempts, needle redirections and bone contacts. Copyright © 2016 Société française d'anesthésie et de réanimation (Sfar). Published by Elsevier Masson SAS. All rights reserved.

  3. Operations dashboard: comparative study

    Science.gov (United States)

    Ramly, Noor Nashriq; Ismail, Ahmad Zuhairi; Aziz, Mohd Haris; Ahmad, Nurul Haszeli

    2011-10-01

    In this present days and age, there are increasing needs for companies to monitor application and infrastructure health. Apart from having proactive measures to secure their application and infrastructure, many see monitoring dashboards as crucial investment in disaster preparedness. As companies struggle to find the best solution to cater for their needs and interest for monitoring their application and infrastructure's health, this paper summarizes the studies made on several known off-the-shelf operations dashboard and in-house developed dashboard. A few criteria of good dashboard are collected from previous studies carried out by several researchers and rank them according to importance and business needs. The finalized criteria that will be discussed in later sections are data visualization, performance indicator, dashboard personalization, audit capability and alert/ notification. Comparative studies between several popular dashboards were then carried out to determine whether they met these criteria that we derived from the first exercise. The findings hopefully can be used to educate and provide an overview of selecting the best IT application and infrastructure operations dashboard that suit business needs, thus become the main contribution of this paper.

  4. 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.

  5. A Component-Based Study of the Effect of Diameter on Bond and Anchorage Characteristics of Blind-Bolted Connections.

    Science.gov (United States)

    Amin, Muhammad Nasir; Zaheer, Salman; Alazba, Abdulrahman Ali; Saleem, Muhammad Umair; Niazi, Muhammad Umar Khan; Khurram, Nauman; Amin, Muhammad Tahir

    2016-01-01

    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.

  6. Nonhuman Primate Studies to Advance Vision Science and Prevent Blindness.

    Science.gov (United States)

    Mustari, Michael J

    2017-12-01

    Most primate behavior is dependent on high acuity vision. Optimal visual performance in primates depends heavily upon frontally placed eyes, retinal specializations, and binocular vision. To see an object clearly its image must be placed on or near the fovea of each eye. The oculomotor system is responsible for maintaining precise eye alignment during fixation and generating eye movements to track moving targets. The visual system of nonhuman primates has a similar anatomical organization and functional capability to that of humans. This allows results obtained in nonhuman primates to be applied to humans. The visual and oculomotor systems of primates are immature at birth and sensitive to the quality of binocular visual and eye movement experience during the first months of life. Disruption of postnatal experience can lead to problems in eye alignment (strabismus), amblyopia, unsteady gaze (nystagmus), and defective eye movements. Recent studies in nonhuman primates have begun to discover the neural mechanisms associated with these conditions. In addition, genetic defects that target the retina can lead to blindness. A variety of approaches including gene therapy, stem cell treatment, neuroprosthetics, and optogenetics are currently being used to restore function associated with retinal diseases. Nonhuman primates often provide the best animal model for advancing fundamental knowledge and developing new treatments and cures for blinding diseases. © The Author(s) 2017. Published by Oxford University Press on behalf of the National Academy of Sciences. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  7. 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.

  8. Comparative waste forms study

    International Nuclear Information System (INIS)

    Wald, J.W.; Lokken, R.O.; Shade, J.W.; Rusin, J.M.

    1980-12-01

    A number of alternative process and waste form options exist for the immobilization of nuclear wastes. Although data exists on the characterization of these alternative waste forms, a straightforward comparison of product properties is difficult, due to the lack of standardized testing procedures. The characterization study described in this report involved the application of the same volatility, mechanical strength and leach tests to ten alternative waste forms, to assess product durability. Bulk property, phase analysis and microstructural examination of the simulated products, whose waste loading varied from 5% to 100% was also conducted. The specific waste forms investigated were as follows: Cold Pressed and Sintered PW-9 Calcine; Hot Pressed PW-9 Calcine; Hot Isostatic Pressed PW-9 Calcine; Cold Pressed and Sintered SPC-5B Supercalcine; Hot Isostatic pressed SPC-5B Supercalcine; Sintered PW-9 and 50% Glass Frit; Glass 76-68; Celsian Glass Ceramic; Type II Portland Cement and 10% PW-9 Calcine; and Type II Portland Cement and 10% SPC-5B Supercalcine. Bulk property data were used to calculate and compare the relative quantities of waste form volume produced at a spent fuel processing rate of 5 metric ton uranium/day. This quantity ranged from 3173 L/day (5280 Kg/day) for 10% SPC-5B supercalcine in cement to 83 L/day (294 Kg/day) for 100% calcine. Mechanical strength, volatility, and leach resistance tests provide data related to waste form durability. Glass, glass-ceramic and supercalcine ranked high in waste form durability where as the 100% PW-9 calcine ranked low. All other materials ranked between these two groupings

  9. A prospective, randomized, double blind and placebo-control study comparing the additive effect of oral midazolam and clonidine for postoperative nausea and vomiting prophylaxis in granisetron premedicated patients undergoing laparoscopic cholecystecomy

    Directory of Open Access Journals (Sweden)

    Ghanshyam Yadav

    2013-01-01

    Full Text Available Background: Reduction of postoperative nausea and vomiting (PONV continues to be a major challenge in perioperative care in spite of introduction of newer antiemetics with better efficacy and safety profiles. Therefore, we evaluated the additive effect of oral midazolam and clonidine for PONV prophylaxis in granisetron premedicated patients undergoing laparoscopic cholecystectomy. Materials and Methods: In a prospective, randomized fashion, 120 selected cases were randomized into three groups: I, II or III to receive a tablet of midazolam (15 mg, n = 36, clonidine (150 mcg, n = 40, or glucose as placebo (5 g, n = 44 orally, 1 h before anesthesia. Occurrence of PONV along with need for rescue antiemetic during the first postoperative day was compared between groups as a primary outcome. Results: Episodes of PONV reduced significantly in Group II (15% as compared to group I and III (22.2%, 59% at various time points during the period of observation (P = 0.002. Need for rescue antiemetic was significantly lower in group I (13.88% and II (5% as compared to group III (52.27%, P < 0.001. Conclusion: Oral clonidine is better adjuvant for PONV prophylaxis, as compared to midazolam, in granisetron premedicated patients undergoing laparoscopic cholecystectomy.

  10. Comparative ultrasound study of acute lateral ankle ligament ...

    African Journals Online (AJOL)

    The return to competitive level of sport dates were also documented and compared. A single blind randomised control study comparing the JSFB rehabilitation programme with conventional ankle rehabilitation programmes was used. Ultrasound examinations were done on all first time lateral ankle ligament injuries 72 ...

  11. A Study of Curriculum Development and Reform in Residential Schools for the Blind in the United States: Three Case Studies

    Science.gov (United States)

    Holiday, Jeremiah

    2013-01-01

    This study was conducted to understand curriculum development in residential schools for the blind after the enactment of NCLB and was guided by the research question, "How do residential schools for the blind and visually impaired develop their curriculum to meet the unique needs of students who are blind and visually impaired?" In the…

  12. Comparative evaluation of atenolol and clonidine premedication on cardiovascular response to nasal speculum insertion during trans-sphenoid surgery for resection of pituitary adenoma: A prospective, randomised, double-blind, controlled study

    Directory of Open Access Journals (Sweden)

    Devendra Gupta

    2011-01-01

    Full Text Available Severe cardiovascular responses in the form of tachycardia and hypertension following nasal speculum insertion occur during sublabial rhinoseptal trans-sphenoid approach for resection of small pituitary tumours. We compare the effects of preoperative administration of clonidine (α-2 agonist and atenolol (α-blocker over haemodynamic response, caused by speculum insertion during trans-sphenoid pituitary resection. We enrolled 66 patients in age range 18-65 years, of ASA I-II, and of either sex undergoing elective sublabial rhinoseptal trans-sphenoidal hypophysectomy. Group I (control received placebo, group II (clonidine received tablet clonidine 5 μg/kg, and group III (atenolol received tablet atenolol 0.5 mg/kg. The heart rate increased on speculum insertion and 5 and 10 minutes following speculum insertion as compared to the pre-speculum values in the control group, while no change in the heart rate was observed in other groups (P<0.05. There was a rise in the mean arterial pressure during and 5, 10, and 15 minutes after nasal speculum insertion in the control group, whereas it was not seen in other groups (P<0.05. We therefore suggest that oral clonidine and oral atenolol (given 2 hours prior to surgery is an equally effective and safe method of attenuating haemodynamic response caused by nasal speculum insertion during trans-sphenoid pituitary resection.

  13. Brief report: pulmonary auscultation in the operating room: a prospective randomized blinded trial comparing electronic and conventional stethoscopes.

    Science.gov (United States)

    Hoffmann, Clement; Falzone, Elisabeth; Verret, Catherine; Pasquier, Pierre; Leclerc, Thomas; Donat, Nicolas; Jost, Daniel; Mérat, Stephane; Maurice, Guillaume de Saint; Lenoir, Bernard; Auroy, Yves; Tourtier, Jean-Pierre

    2013-09-01

    We compared the subjective quality of pulmonary auscultation between 2 acoustic stethoscopes (Holtex Ideal® and Littmann Cardiology III®) and an electronic stethoscope (Littmann 3200®) in the operating room. A prospective double-blind randomized study with an evaluation during mechanical ventilation was performed in 100 patients. After each examination, the listeners using a numeric scale (0-10) rated the quality of auscultation. Auscultation quality was compared in patients among stethoscopes with a multilevel mixed-effects linear regression with random intercept (operator effect), adjusted on significant factors in univariate analysis. A significant difference was defined as P auscultation were performed. The quality of auscultation was rated 8.2 ± 1.6 for the electronic stethoscope, 7.4 ± 1.8 for the Littmann Cardiology III, and 4.6 ± 1.8 for the Holtex Ideal. Compared with Holtex Ideal, auscultation quality was significantly higher with other stethoscopes (P auscultation quality was significantly higher with Littmann 3200 electronic stethoscope (β = 0.9 [95% confidence interval, 0.5-1.3]). An electronic stethoscope can provide a better quality of pulmonary auscultation than acoustic stethoscopes in the operating room, yet with a magnitude of improvement marginally higher than that provided with a high performance acoustic stethoscope. Whether this can translate into a clinically relevant benefit requires further studies.

  14. Celecoxib Monotherapy Maintained Small Intestinal Mucosa Better Compared With Loxoprofen Plus Lansoprazole Treatment: A Double-blind, Randomized, Controlled Trial.

    Science.gov (United States)

    Fujimori, Shunji; Hanada, Ryuzo; Hayashida, Mari; Sakurai, Toshiyuki; Ikushima, Ippei; Sakamoto, Choitsu

    2016-03-01

    The aim of this study was to compare celecoxib with loxoprofen for protection of small intestine. RCT studies report that COX-2 selective inhibitor celecoxib induces fewer small intestinal injuries than nonselective nonsteroidal anti-inflammatory drugs (NSAIDs). Loxoprofen is a prodrug nonselective NSAID developed to protect upper gastrointestinal tract. A total of 150 healthy volunteers (40 to 70 y) were enrolled. After medical checkup including laboratory data, subjects were randomly assigned to celecoxib (200 mg daily) or loxoprofen (180 mg daily) plus lansoprazole (15 mg daily). All drugs were prepared using inactive capsules. After randomization, all subjects were first examined by baseline capsule endoscopy (CE). After 14 days, subjects underwent posttreatment CE. We compared baseline and posttreatment CE findings of the 2 groups. All CE data were evaluated blindly by 3 reviewers. Pretreatment and posttreatment laboratory variables were also compared. A total of 74 subjects (49±6 y, F/M: 36/38) were enrolled in celecoxib group and 76 subjects (49±7 y, F/M: 39/37)in loxoprofen group. Five in celecoxib group and 4 in loxoprofen group were excluded from CE analysis mainly due to incomplete CE. The percentage of subjects with at least 1 posttreatment mucosal break was lower in celecoxib group (10%) than in loxoprofen group (49%) (Plansoprazole combination therapy (UMIN: 000007936).

  15. Adaptive changes in early and late blind: a fMRI study of Braille reading.

    Science.gov (United States)

    Burton, H; Snyder, A Z; Conturo, T E; Akbudak, E; Ollinger, J M; Raichle, M E

    2002-01-01

    Braille reading depends on remarkable adaptations that connect the somatosensory system to language. We hypothesized that the pattern of cortical activations in blind individuals reading Braille would reflect these adaptations. Activations in visual (occipital-temporal), frontal-language, and somatosensory cortex in blind individuals reading Braille were examined for evidence of differences relative to previously reported studies of sighted subjects reading print or receiving tactile stimulation. Nine congenitally blind and seven late-onset blind subjects were studied with fMRI as they covertly performed verb generation in response to reading Braille embossed nouns. The control task was reading the nonlexical Braille string "######". This study emphasized image analysis in individual subjects rather than pooled data. Group differences were examined by comparing magnitudes and spatial extent of activated regions first determined to be significant using the general linear model. The major adaptive change was robust activation of visual cortex despite the complete absence of vision in all subjects. This included foci in peri-calcarine, lingual, cuneus and fusiform cortex, and in the lateral and superior occipital gyri encompassing primary (V1), secondary (V2), and higher tier (VP, V4v, LO and possibly V3A) visual areas previously identified in sighted subjects. Subjects who never had vision differed from late blind subjects in showing even greater activity in occipital-temporal cortex, provisionally corresponding to V5/MT and V8. In addition, the early blind had stronger activation of occipital cortex located contralateral to the hand used for reading Braille. Responses in frontal and parietal cortex were nearly identical in both subject groups. There was no evidence of modifications in frontal cortex language areas (inferior frontal gyrus and dorsolateral prefrontal cortex). Surprisingly, there was also no evidence of an adaptive expansion of the somatosensory or

  16. Mobile OS Comparative Study

    OpenAIRE

    Joseph, Jyothy; K, Shinto Kurian

    2013-01-01

    In the fast growing mobile revolutionary era, many operating systems are playing vital role in present market. This study is intending to identify the apt and secure mobile based on mobile operating systems capability and user requirements.

  17. Chemical and morphological analysis of kidney stones: a double-blind comparative study Análise química e morfológica de cálculos renais: estudo comparativo duplo-cego

    Directory of Open Access Journals (Sweden)

    Silvia Fernandes Ribeiro da Silva

    2010-10-01

    Full Text Available PURPOSE: To compare chemical to morphological kidney stone composition analysis based on a sample of 50 stones retrieved from patients at a nephrology service. METHODS: The chemical analysis was performed with a Bioclin® kit, while a 10-mm magnifying glass (10x; Prolabo, Paris, France was employed in the morphological analysis. Findings obtained with the two methods were compared and classified as concordant (100% agreement, partly concordant (concordant for major components, discordant for minor components or discordant (discordant for major components. RESULTS: In the chemical analysis, the most commonly observed major component was calcium (70%, followed by oxalate (66%, ammonium (56%, urate (28% and carbonate (24%. In the morphological analysis, the most commonly observed major components were calcium phosphate and magnesium (32% each, followed by calcium oxalate monohydrate (24%, uric acid and urates (20% each, calcium oxalate dihydrate (18% and cystine (6%. Infectious kidney stones were identified in 34% and 24% of cases by morphological and chemical analysis, respectively. Thirty-eight percent of the samples were classified as concordant, 52% were partly concordant and 10% were discordant. CONCLUSION: We suggest kidney stones be routinely submitted to both types of analysis for a better understanding of the mechanisms involved in lithogenesis.OBJETIVO: Comparar a análise química com a análise morfológica de 50 cálculos urinários provenientes de pacientes em um serviço de nefrologia. MÉTODOS: A análise química foi realizada utilizando o kit da Bioclin®, enquanto que a morfológica foi realizada com auxílio de uma lupa de 10mm (Prolabo, Paris, France. A comparação entre as técnicas foi classificada em concordante (100% de concordância, parcialmente concordante (componentes majoritários concordantes e minoritários discordantes e discordante (discordância nos componentes majoritários. RESULTADOS: Na análise química os

  18. Prospective, randomized, double-blind, Phase 2 dose-ranging study comparing efficacy and safety of imipenem/cilastatin plus relebactam with imipenem/cilastatin alone in patients with complicated urinary tract infections.

    Science.gov (United States)

    Sims, Matthew; Mariyanovski, Valeri; McLeroth, Patrick; Akers, Wayne; Lee, Yu-Chieh; Brown, Michelle L; Du, Jiejun; Pedley, Alison; Kartsonis, Nicholas A; Paschke, Amanda

    2017-09-01

    The β-lactamase inhibitor relebactam can restore imipenem activity against imipenem non-susceptible pathogens. To explore relebactam's safety, tolerability and efficacy, we conducted a randomized (1:1:1), controlled, Phase 2 trial comparing imipenem/cilastatin+relebactam 250 mg, imipenem/cilastatin+relebactam 125 mg and imipenem/cilastatin alone in adults with complicated urinary tract infections (cUTI) or acute pyelonephritis, regardless of baseline pathogen susceptibility. Treatment was administered intravenously every 6 h for 4-14 days, with optional step-down to oral ciprofloxacin. The primary endpoint was favourable microbiological response rate (pathogen eradication) at discontinuation of intravenous therapy (DCIV) in the microbiologically evaluable (ME) population. Non-inferiority of imipenem/cilastatin+relebactam over imipenem/cilastatin alone was defined as lower bounds of the 95% CI for treatment differences being above -15%. At DCIV, 71 patients in the imipenem/cilastatin + 250 mg relebactam, 79 in the imipenem/cilastatin + 125 mg relebactam and 80 in the imipenem/cilastatin-only group were ME; 51.7% had cUTI and 48.3% acute pyelonephritis. Microbiological response rates were 95.5%, 98.6% and 98.7%, respectively, confirming non-inferiority of both imipenem/cilastatin + relebactam doses to imipenem/cilastatin alone. Clinical response rates were 97.1%, 98.7% and 98.8%, respectively. All 23 ME patients with imipenem non-susceptible pathogens had favourable DCIV microbiological responses (100% in each group). Among all 298 patients treated, 28.3%, 29.3% and 30.0% of patients, respectively, had treatment-emergent adverse events. The most common treatment-related adverse events across groups (1.0%-4.0%) were diarrhoea, nausea and headache. Imipenem/cilastatin + relebactam (250 or 125 mg) was as effective as imipenem/cilastatin alone for treatment of cUTI. Both relebactam-containing regimens were well tolerated. (NCT01505634).

  19. The effect on knee-joint load of instruction in analgesic use compared with neuromuscular exercise in patients with knee osteoarthritis: study protocol for a randomized, single-blind, controlled trial (the EXERPHARMA trial).

    Science.gov (United States)

    Clausen, Brian; Holsgaard-Larsen, Anders; Søndergaard, Jens; Christensen, Robin; Andriacchi, Thomas P; Roos, Ewa M

    2014-11-15

    Knee osteoarthritis (OA) is a mechanically driven disease, and it is suggested that medial tibiofemoral knee-joint load increases with pharmacologic pain relief, indicating that pharmacologic pain relief may be positively associated with disease progression. Treatment modalities that can both relieve pain and reduce knee-joint load would be preferable. The knee-joint load is influenced by functional alignment of the trunk, pelvis, and lower-limb segments with respect to the knee, as well as the ground-reaction force generated during movement. Neuromuscular exercise can influence knee load and decrease knee pain. It includes exercises to improve balance, muscle activation, functional alignment, and functional knee stability. The primary objective of this randomized controlled trial (RCT) is to investigate the efficacy of a NEuroMuscular EXercise (NEMEX) therapy program, compared with optimized analgesics and antiinflammatory drug use, on the measures of knee-joint load in people with mild to moderate medial tibiofemoral knee osteoarthritis. One hundred men and women with mild to moderate medial knee osteoarthritis will be recruited from general medical practices and randomly allocated (1:1) to one of two 8-week treatments, either (a) NEMEX therapy twice a week or (b) information on the recommended use of analgesics and antiinflammatory drugs (acetaminophen and oral NSAIDs) via a pamphlet and video materials. The primary outcome is change in knee load during walking (the Knee Index, a composite score of the first external peak total reaction moment on the knee joint from all three planes based on 3D movement analysis) after 8 weeks of intervention. Secondary outcomes include changes in the external peak knee-adduction moment and impulse and functional performance measures, in addition to changes in self-reported pain, function, health status, and quality of life. These findings will help determine whether 8 weeks of neuromuscular exercise is superior to optimized use

  20. 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 blindness during the 12-year period was estimated. The population 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.

  1. Comparative Packaging Study

    Science.gov (United States)

    Perchonok, Michele H.; Oziomek, Thomas V.

    2009-01-01

    Future long duration manned space flights beyond low earth orbit will require the food system to remain safe, acceptable and nutritious. Development of high barrier food packaging will enable this requirement by preventing the ingress and egress of gases and moisture. New high barrier food packaging materials have been identified through a trade study. Practical application of this packaging material within a shelf life test will allow for better determination of whether this material will allow the food system to meet given requirements after the package has undergone processing. The reason to conduct shelf life testing, using a variety of packaging materials, stems from the need to preserve food used for mission durations of several years. Chemical reactions that take place during longer durations may decrease food quality to a point where crew physical or psychological well-being is compromised. This can result in a reduction or loss of mission success. The rate of chemical reactions, including oxidative rancidity and staling, can be controlled by limiting the reactants, reducing the amount of energy available to drive the reaction, and minimizing the amount of water available. Water not only acts as a media for microbial growth, but also as a reactant and means by which two reactants may come into contact with each other. The objective of this study is to evaluate three packaging materials for potential use in long duration space exploration missions.

  2. A randomized, double-blind, phase III study comparing two doses of erlotinib for second-line treatment of current smokers with advanced non-small-cell lung cancer (CurrentS).

    Science.gov (United States)

    Smit, Egbert F; Wu, Yi-Long; Gervais, Radj; Zhou, Caicun; Felip, Enriqueta; Feng, Jifeng; Guclu, Salih Zeki; Hoiczyk, Mathias; Dorokhova, Elena; Freudensprung, Ulrich; Grange, Susan; Perez-Moreno, Pablo Diego; Mitchell, Lada; Reck, Martin

    2016-09-01

    Active smokers with non-small-cell lung cancer (NSCLC) have increased erlotinib metabolism versus non-smoking patients, which reduces exposure. Therefore, an increased erlotinib dose may be beneficial. The CurrentS study (NCT01183858) assessed efficacy and safety of 300mg erlotinib (E300) as second-line therapy in current smokers with locally advanced or metastatic NSCLC versus the standard 150mg dose (E150). Patients with stage IIIB/IV NSCLC (current smokers who failed first-line platinum-based chemotherapy) were randomized to receive E150 or E300 until progression/death/unacceptable toxicity. progression-free survival (PFS). Secondary endpoints: overall survival (OS), disease control rate and safety. A total of 342 patients were screened; the intent-to-treat population comprised 159 E300 patients and 154 E150 patients. Median PFS was 7.0 versus 6.9 weeks with E300 versus E150, respectively (unstratified hazard ratio [HR]=1.05, 95% confidence interval [CI]: 0.83-1.33; unstratified log-rank P=0.671). Median OS was 6.8 months in both arms (unstratified HR=1.03, 95% CI: 0.80-1.32; unstratified log-rank P=0.846). Overall, 89.2% (E300 arm) and 84.4% (E150 arm) experienced ≥1 adverse event (AE) of any grade (44.3% and 37%, respectively, experienced grade ≥3 AEs); AEs of special interest were reported in 67.7% and 47.4% of patients, respectively. E300 resulted in higher mean plasma concentrations versus E150, however, this did not improve efficacy. Despite the difference in erlotinib exposure, there was no evidence of an incremental efficacy benefit of a higher erlotinib dose versus the standard dose in this population of highly active smokers. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  3. Surgical site infection: an observer-blind, randomized trial comparing electrocautery and conventional scalpel.

    Science.gov (United States)

    Rongetti, Regiane Ladislau; Oliveira e Castro, Paulo de Tarso; Vieira, Renê Aloisio da Costa; Serrano, Sérgio Vicente; Mengatto, Mariana Fabro; Fregnani, José Humberto Tavares Guerreiro

    2014-01-01

    To evaluate the incidence of surgical site infection (SSI) based on the type of scalpel used for incisions in the skin and in subcutaneous tissues. Observer-blind, randomized equivalence clinical trial with two arms (electrocautery versus conventional scalpel) which evaluated 133 women undergoing elective abdominal gynecologic oncology surgery. A simple randomization stratified by body mass index (BMI: 30 kg/m(2)) was carried out. Women were evaluated at 14 and 30 days following the operation. A multivariate analysis was performed in order to check whether the type of scalpel would be a risk factor for SSI. Group arms were balanced for all variables, excepted for surgical time, which was significantly higher in the electrocautery group (mean: 161.1 versus 203.5 min, P = 0.029). The rates of SSI were 7.4% and 9.7%, respectively, for the conventional scalpel and electrocautery groups (P = 0.756). The exploratory multivariate model identified body mass index ≥30 kg/m(2) (OR = 24.2, 95% CI: 2.8-212.1) and transverse surgical incision (OR = 8.1, 95% CI: 1.5-42.6) as independent risk factors for SSI. The type of scalpel used in surgery, when adjusted for these variables and the surgery time, was not a risk factor for SSI. This study showed that the SSI rates for conventional scalpel and electrocautery were not significantly different. These results were consistent with others reported in the literature and would not allow a surgeon to justify scalpel choice based on SSI. NCT01410175 (Clinical Trials - NIH). Copyright © 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

  4. Etoricoxib in the treatment of osteoarthritis over 52-weeks: a double-blind, active-comparator controlled trial [NCT00242489

    Directory of Open Access Journals (Sweden)

    Olaleye Joseph

    2005-12-01

    Full Text Available Abstract Background The aim of this study was to evaluate the long-term efficacy and tolerability of etoricoxib, a COX-2 selective inhibitor, in osteoarthritis (OA patients. Methods A double-blind, randomized, multicenter study was conducted in 617 patients with OA of the knee. The base study was 14 weeks in duration and consisted of 2 parts; in Part I (6 weeks, patients were allocated to once daily oral etoricoxib 5, 10, 30, 60, 90 mg or placebo. In Part II (8 weeks; the placebo, etoricoxib 5 and 10 mg groups were reallocated to etoricoxib 30, 60, or 90 mg qd or diclofenac 50 mg t.i.d. Treatment was continued for consecutive 12 and 26 week extensions. Primary efficacy endpoints were the WOMAC VA 3.0 pain subscale and investigator global assessment of disease status. Safety and tolerability were assessed by collecting adverse events throughout the study. Results Compared with placebo, the etoricoxib groups displayed significant (p Conclusion In this extension study, etoricoxib, at doses ranging from 30 to 90 mg, demonstrated a maintenance of significant clinical efficacy in patients with OA through 52 weeks of treatment. Etoricoxib displayed clinical efficacy similar to diclofenac 150 mg and was generally well tolerated.

  5. 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.

  6. Factors associated with childhood ocular morbidity and blindness in three ecological regions of Nepal: Nepal pediatric ocular disease study.

    Science.gov (United States)

    Adhikari, Srijana; Shrestha, Mohan Krishna; Adhikari, Kamala; Maharjan, Nhukesh; Shrestha, Ujjowala Devi

    2014-10-23

    Nepal Pediatric Ocular Diseases Study is a three year longitudinal population based study. Here we present the baseline survey report which aims to investigate various risk factors associated with childhood ocular morbidity and blindness in three ecological regions of Nepal. This baseline survey is a population based cross sectional study. The investigation was conducted in a district from each of the following regions: Terai, Hill and Mountain. The Village Development Committees (VDCs) from each district were selected by random sampling. Three Community health workers were given training on vision screening and identification of abnormal ocular signs in children. They conducted a house to house survey in their respected districts examining the children and gathering a standardized set of data variables. Children with abnormal vision or ocular signs were then further examined by pediatric ophthalmologists. A total of 10950 children aged 0-10 years (5403 from Terai, 3204 from the hills, 2343 from the mountains) were enrolled in the study. However 681 (6.2%) were non responders. The male to female ratio was 1.03. The overall prevalence of ocular morbidity was 3.7% (95% CI of 3.4%-4%) and blindness was 0.07% (95% CI of 0.02%-0.12%). Ocular morbidity was more prevalent in the mountain region whereas blindness was more prevalent in the Terai region.Children from the Terai region were more likely to suffer from congenital ocular anomalies compared to the other regions. Children whose mother smoked, drank alcohol, or was illiterate were significantly afflicted with ocular diseases (p Blindness was more prevalent in children who suffered from a systemic illness. Females and under-nourished children were more likely to have ocular morbidity and blindness. It was found that childhood blindness was more prevalent in the Terai region, the undernourished, females and in those with co-morbid systemic illnesses. This study strongly suggests that prevention of childhood

  7. Randomized, double-blinded, placebo-controlled trial comparing two multimodal opioid-minimizing pain management regimens following transsphenoidal surgery.

    Science.gov (United States)

    Shepherd, Deborah M; Jahnke, Heidi; White, William L; Little, Andrew S

    2018-02-01

    OBJECTIVE Pain control is an important clinical consideration and quality-of-care metric. No studies have examined postoperative pain control following transsphenoidal surgery for pituitary lesions. The study goals were to 1) report postoperative pain scores following transsphenoidal surgery, 2) determine if multimodal opioid-minimizing pain regimens yielded satisfactory postoperative pain control, and 3) determine if intravenous (IV) ibuprofen improved postoperative pain scores and reduced opioid use compared with placebo. METHODS This study was a single-center, randomized, double-blinded, placebo-controlled intervention trial involving adult patients with planned transsphenoidal surgery for pituitary tumors randomized into 2 groups. Group 1 patients were treated with scheduled IV ibuprofen, scheduled oral acetaminophen, and rescue opioids. Group 2 patients were treated with IV placebo, scheduled oral acetaminophen, and rescue opioids. The primary end point was patient pain scores (visual analog scale [VAS], rated 0-10) for 48 hours after surgery. The secondary end point was opioid use as estimated by oral morphine equivalents (OMEs). RESULTS Of 136 patients screened, 62 were enrolled (28 in Group 1, 34 in Group 2). The study was terminated early because the primary and secondary end points were reached. Baseline characteristics between groups were well matched except for age (Group 1, 59.3 ± 14.4 years; Group 2, 49.8 ± 16.2 years; p = 0.02). Mean VAS pain scores were significantly different, with a 43% reduction in Group 1 (1.7 ± 2.2) compared with Group 2 (3.0 ± 2.8; p transsphenoidal surgery. IV ibuprofen resulted in significantly improved pain scores and significantly decreased opioid use compared with placebo. Postoperative multimodal pain management, including a nonsteroidal antiinflammatory medication, should be considered after surgery to improve patient comfort and to limit opioid use. Clinical trial registration no.: NCT02351700 (clinicaltrials

  8. 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.

  9. Effect of omeprazole and sucralfate on prepyloric gastric ulcer. A double blind comparative trial and one year follow up.

    Science.gov (United States)

    Sørensen, H T; Rasmussen, H H; Balslev, I; Boesby, S; Boné, J; Kruse, A; Rasmussen, S N

    1994-01-01

    This study compared healing rates, relief of symptoms, frequency of adverse events, and proportion of patients in remission after one year follow up in 104 patients with active prepyloric ulcer during treatment with 40 mg omeprazole once daily or 2 g sucralfate twice daily, using a randomised double blind controlled trial. Healing rates after two, four, and six weeks were (omeprazole/sucralfate) 49%/23%; 83%/59%; 90%/70% respectively. After two weeks, omeprazole was more efficient than sucralfate in relief of daytime and nocturnal epigastric pain, nausea, and heartburn. The proportion of patients in remission after one year follow up was significantly higher in the omeprazole group (p < 0.01). Of the healed patients ulcers recurred in 36% in the omeprazole group and in 46% in the sucralfate group. It is concluded that the ulcer healing rate was higher and symptom relief was more pronounced in the omeprazole group compared with the sucralfate group, and that more patients were still in remission after a one year follow up period. PMID:8020815

  10. Botulinum toxin in the treatment of orofacial tardive dyskinesia : A single blind study

    NARCIS (Netherlands)

    Slotema, Christina W.; van Harten, Peter N.; Bruggeman, Richard; Hoek, Hans W.

    2008-01-01

    Objective: Orofacial tardive dyskinesia (OTD) is difficult to treat and Botulinium Toxin A (BTA) may be an option. Methods: In a single blind (raters were blind) study (N= 12, duration 33 weeks) OTD was treated with Botulinum Toxin A in three consecutive sessions with increasing dosages. The

  11. Post-prandial reflux suppression by a raft-forming alginate (Gaviscon Advance) compared to a simple antacid documented by magnetic resonance imaging and pH-impedance monitoring: mechanistic assessment in healthy volunteers and randomised, controlled, double-blind study in reflux patients.

    Science.gov (United States)

    Sweis, R; Kaufman, E; Anggiansah, A; Wong, T; Dettmar, P; Fried, M; Schwizer, W; Avvari, R K; Pal, A; Fox, M

    2013-06-01

    Alginates form a raft above the gastric contents, which may suppress gastro-oesophageal reflux; however, inconsistent effects have been reported in mechanistic and clinical studies. To visualise reflux suppression by an alginate-antacid [Gaviscon Advance (GA), Reckitt Benckiser, UK] compared with a nonraft-forming antacid using magnetic resonance imaging (MRI), and to determine the feasibility of pH-impedance monitoring for assessment of reflux suppression by alginates. Two studies were performed: (i) GA and antacid (Alucol, Wander Ltd, Switzerland) were visualised in the stomach after ingestion in 12 healthy volunteers over 30 min after a meal by MRI, with reflux events documented by manometry. (ii) A randomised controlled, double-blind cross-over trial of post-prandial reflux suppression documented by pH-impedance in 20 patients randomised to GA or antacid (Milk of Magnesia; Boots, UK) after two meals taken 24 h apart. MRI visualized a "mass" of GA form at the oesophago-gastric junction (OGJ); simple antacid sank to the distal stomach. The number of post-prandial common cavity reflux events was less with GA than antacid [median 2 (0-5) vs. 5 (1-11); P < 0.035]. Distal reflux events and acid exposure measured by pH-impedance were similar after GA and antacid. There was a trend to reduced proximal reflux events with GA compared with antacid [10.5 (8.9) vs. 13.9 (8.3); P = 0.070]. Gaviscon Advance forms a 'mass' close to the OGJ and significantly suppresses reflux compared with a nonraft-forming antacid. Standard pH-impedance monitoring is suitable for clinical studies of GA in gastro-oesophageal reflux disease patients where proximal reflux is the primary outcome. © 2013 Blackwell Publishing Ltd.

  12. 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.

  13. Recognition Memory for Braille or Spoken Words: An fMRI study in Early Blind

    Science.gov (United States)

    Burton, Harold; Sinclair, Robert J.; Agato, Alvin

    2012-01-01

    We examined cortical activity in early blind during word recognition memory. Nine participants were blind at birth and one by 1.5 yrs. 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. PMID:22251836

  14. 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.

  15. Foreground-background segmentation and attention: a change blindness study.

    Science.gov (United States)

    Mazza, Veronica; Turatto, Massimo; Umiltà, Carlo

    2005-01-01

    One of the most debated questions in visual attention research is what factors affect the deployment of attention in the visual scene? Segmentation processes are influential factors, providing candidate objects for further attentional selection, and the relevant literature has concentrated on how figure-ground segmentation mechanisms influence visual attention. However, another crucial process, namely foreground-background segmentation, seems to have been neglected. By using a change blindness paradigm, we explored whether attention is preferentially allocated to the foreground elements or to the background ones. The results indicated that unless attention was voluntarily deployed to the background, large changes in the color of its elements remained unnoticed. In contrast, minor changes in the foreground elements were promptly reported. Differences in change blindness between the two regions of the display indicate that attention is, by default, biased toward the foreground elements. This also supports the phenomenal observations made by Gestaltists, who demonstrated the greater salience of the foreground than the background.

  16. General vs health specialized search engine: a blind comparative evaluation of top search results.

    Science.gov (United States)

    Pletneva, Natalia; Ruiz de Castaneda, Rafael; Baroz, Frederic; Boyer, Celia

    2014-01-01

    This paper presents the results of a blind comparison of top ten search results retrieved by Google.ch (French) and Khresmoi for everyone, a health specialized search engine. Participants--students of the Faculty of Medicine of the University of Geneva had to complete three tasks and select their preferred results. The majority of the participants have largely preferred Google results while Khresmoi results showed potential to compete in specific topics. The coverage of the results seems to be one of the reasons. The second being that participants do not know how to select quality and transparent health web pages. More awareness, tools and education about the matter is required for the students of Medicine to be able to efficiently distinguish trustworthy online health information.

  17. Hydroxyurea: a radiation potentiator in carcinoma of the uterine cervix. A randomized double-blind study

    International Nuclear Information System (INIS)

    Piver, M.S.; Barlow, J.J.; Vongtama, V.; Blumenson, L.

    1983-01-01

    From June, 1972, to December, 1976, 40 patients with FIGO (International Federation of Gynaecology and Obstetrics) Stage IIB carcinoma of the uterine cervix were entered into a prospective, double-blind, randomized study to evaluate the possible radiation-potentiating properties (i.e., improved survival) of the S-phase cell cycle-specific inhibitor of DNA synthesis, hydroxyurea. All patients were documented to be without aortic lymph node metastasis by pretherapy staging para-aortic lymphadenectomy. All 40 patients were followed up for longer than 5 years (5.2 to 9.2 years) or until death. The double-blind code was not broken until all patients had been followed up for a minimum of 2 to 5 years. Leukopenia (white blood cell count less than 2,500 mm3) was significantly increased in the patients given hydroxyurea as compared to those given placebo (P less than 0.0001). There was no statistically significant difference relative to anemia, thrombocytopenia, radiation-induced skin reaction, and radiation-induced intestinal reaction between the patients given placebo or those given hydroxyurea. Life-table survival for the patients given hydroxyurea was 94% as compared to 53% for the patients given placebo (P . 0.006). Only one (5%) patient given hydroxyurea died of cervical cancer. Of the other patients who died in the group given hydroxyurea, all were confirmed by postmortem examination to have been without recurrent cervical cancer. In contrast, 45% (nine) of the patients given placebo died of cervical cancer

  18. An alternative approach to treating lateral epicondylitis. A randomized, placebo-controlled, double-blinded study

    NARCIS (Netherlands)

    Nourbakhsh, Mohammad Reza; Fearon, Frank J.

    Objective: To investigate the effect of noxious level electrical stimulation on pain, grip strength and functional abilities in subjects with chronic lateral epicondylitis. Design: Randomized, placebo-control, double-blinded study. Setting: Physical Therapy Department, North Georgia College and

  19. Comparing Different Epinephrine Concentrations for Spinal Anesthesia in Cesarean Section: A Double-Blind Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Arash Hamzei

    2015-07-01

    Full Text Available Background: Although various anesthetic techniques can be used in different kinds of surgeries, spinal anesthesia has received considerable attention for the lower abdomen and lower extremities surgeries and cesarean section. This study aimed at comparing the effect of adding epinephrine 1:1000 and 1:10000 to lidocaine and fentanyl in spinal anesthesia on the prolongation of paralysis, analgesia and hemodynamic changes in pregnant women candidate for cesarean section. Methods: A double blind randomized clinical trial was carried out on 66 pregnant women (equally sized control and treatment groups of 33 in 2011. After randomizing the participants into two groups of recipients of epinephrine 1:1000 plus lidocaine 5% and fentanyl (control group and recipients of epinephrine 1:10000 with lidocaine 5% and fentanyl, (treatment group, the participants’ systolic and diastolic blood pressure and heart rate were recorded before and 1, 3, 5, 10, 15 minutes after procedure. Besides the prolongation of paralysis and analgesia, the presence of postoperative nausea and vomiting were evaluated. The outcome of the study was analyzed using SPSS software and via t test, χ2 test and RMANOVA. Results: The mean age (standard deviation of the participants was 29.3 (4.4 and 28.2 (4.5 in the treatment and control groups, respectively. There were no statistical significance between the participants’ prolongation of paralysis, analgesia, the frequency of nausea and vomiting, and the average values of hemodynamic variables between the two groups. Conclusion: The use of epinephrine 1:10000 along with lidocaine and fentanyl is recommended in spinal anesthesia in pregnant women candidate for cesarean section. Trial Registration Number: IRCT201012225445N1.

  20. Early effect on general interest, and short-term antidepressant efficacy and safety of agomelatine (25-50mg/day) and escitalopram (10-20mg/day) in outpatients with Major Depressive Disorder. A 12-week randomised double-blind comparative study.

    Science.gov (United States)

    Udristoiu, T; Dehelean, P; Nuss, Ph; Raba, V; Picarel-Blanchot, F; de Bodinat, C

    2016-07-15

    A double-blind, randomized, study was conducted in 29 centers in Romania to evaluate the effect of agomelatine 25-50mg/day (n=144 patients) on general interest, overall clinical efficacy, and functionality in comparison with escitalopram 10-20mg/day (n=143 patients) in out-patients diagnosed with moderate to severe Major Depressive Disorder (MDD). The primary endpoint of the study was the score difference between agomelatine and escitalopram were assessed on the item 13 of the Quick Inventory of Depressive Symptomatology (16-Item) Self-Report (QIDS-SR16) over the first week period. Secondary measures include the primary criterion on the 12-week period, the within-group evolution over 12 weeks of the 17-item Hamilton Depression Scale (HAM-D17) total score, CGI severity of illness (CGI-S) and CGI-I scores, and functionality by using the self-rated Sheehan Disability Scale (SDS). After one week, the mean General Interest score showed no statistically significant difference between treatments. Over 12 weeks, patients felt more and more interested in other people and activities than before having taken medication. Both agomelatine and escitalopram improved depressive symptoms and symptom-related functional impairment of patients. Both agomelatine and escitalopram were well-tolerated by patients. The strength of our results would benefit from additional data from trials using a similar design and other active comparators. There was no difference in week 1 changes of interest between agomelatine and escitalopram. The relatively good tolerability of agomelatine and escitalopram is confirmed. Copyright © 2016 Elsevier B.V. All rights reserved.

  1. Phlebitis induced by parenteral treatment with flucloxacillin and cloxacillin: a double-blind study.

    Science.gov (United States)

    Svedhem, A; Alestig, K; Jertborn, M

    1980-01-01

    Two studies were performed on a total of 54 patients with staphylococcal infections. Study I compares with phlebitogenic properties of flucloxacillin after intravenous infusions when either saline or sterile water was used as a solvent. No difference was observed between the two solvents, and the frequency of phlebitis for the total material without respect to solvents was 5% after 1 day of treatment and 13% after 2 days. Study II was a double-blind comparison of phlebitis caused by intravenous infusions of either flucloxacillin or cloxacillin. The frequencies of phlebitis were found to be 18 and 13%, respectively. After 2 days of treatment the frequency of phlebitis increased dramatically for both drugs. All infusions were given through a plastic cannula of 5-cm length and 1.2-mm diameter. PMID:7447412

  2. A randomized single blind crossover trial comparing leather and commercial wrist splints for treating chronic wrist pain in adults

    Science.gov (United States)

    Thiele, Jill; Nimmo, Rachel; Rowell, Wendy; Quinn, Stephen; Jones, Graeme

    2009-01-01

    Background To compare the effectiveness of a custom-made leather wrist splint (LS) with a commercially available fabric splint (FS) in adults with chronic wrist pain. Methods Participants (N = 25, mean age = 54) were randomly assigned to treatment order in a 2-phase crossover trial. Splints were worn for 2 weeks, separated by a one-week washout period. Outcomes were assessed at baseline and after each splint phase using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN), the Canadian Occupational Performance Measure (COPM) and Jamar dynamometer by an observer blinded to treatment allocation. Results Both styles of wrist splint significantly reduced pain (effect size LS 0.79, FS 0.43), improved hand function and increased grip strength compared to baseline (all p leather splint compared to the commercially available splint. Conclusion Leather wrist splints were superior to a commercially available fabric splint for the short-term relief of pain and dysfunction. PMID:19843345

  3. Fixed, low radiant exposure vs. incremental radiant exposure approach for diode laser hair reduction: a randomized, split axilla, comparative single-blinded trial.

    Science.gov (United States)

    Pavlović, M D; Adamič, M; Nenadić, D

    2015-12-01

    Diode lasers are the most commonly used treatment modalities for unwanted hair reduction. Only a few controlled clinical trials but not a single randomized controlled trial (RCT) compared the impact of various laser parameters, especially radiant exposure, onto efficacy, tolerability and safety of laser hair reduction. To compare the safety, tolerability and mid-term efficacy of fixed, low and incremental radiant exposures of diode lasers (800 nm) for axillary hair removal, we conducted an intrapatient, left-to-right, patient- and assessor-blinded and controlled trial. Diode laser (800 nm) treatments were evaluated in 39 study participants (skin type II-III) with unwanted axillary hairs. Randomization and allocation to split axilla treatments were carried out by a web-based randomization tool. Six treatments were performed at 4- to 6-week intervals with study subjects blinded to the type of treatment. Final assessment of hair reduction was conducted 6 months after the last treatment by means of blinded 4-point clinical scale using photographs. The primary endpoint was reduction in hair growth, and secondary endpoints were patient-rated tolerability and satisfaction with the treatment, treatment-related pain and adverse effects. Excellent reduction in axillary hairs (≥ 76%) at 6-month follow-up visit after receiving fixed, low and incremental radiant exposure diode laser treatments was obtained in 59% and 67% of study participants respectively (Z value: 1.342, P = 0.180). Patients reported lower visual analogue scale (VAS) pain score on the fixed (4.26) than on the incremental radiant exposure side (5.64) (P diode laser treatments were less painful and better tolerated. © 2015 European Academy of Dermatology and Venereology.

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

    Science.gov (United States)

    Vijaya, Lingam; George, Ronnie; Asokan, Rashima; Velumuri, Lokapavani; Ramesh, Sathyamangalam Ve

    2014-04-01

    To evaluate the prevalence and causes of low vision and blindness in an urban south Indian population. 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. 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. Chi-square test, t-test, and multivariate analysis were used. 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%). In this urban population based study, cataract was the leading cause for blindness and refractive error was the main reason for low vision.

  5. 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.

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

    Science.gov (United States)

    Vijaya, Lingam; George, Ronnie; Asokan, Rashima; Velumuri, Lokapavani; Ramesh, Sathyamangalam Ve

    2014-01-01

    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. PMID:23619490

  7. Identifying risk factors for blindness from primary open-angle glaucoma by race: a case-control study.

    Science.gov (United States)

    Williams, Andrew M; Huang, Wei; Muir, Kelly W; Stinnett, Sandra S; Stone, Jordan S; Rosdahl, Jullia A

    2018-01-01

    To examine the factors associated with blindness from primary open-angle glaucoma (POAG) among black and white patients at our institution. For this retrospective, case-control study, patients legally blind from POAG ("cases") were matched on age, race, and gender with non-blind POAG patients ("controls"). Thirty-seven black case-control pairs and 19 white case-control pairs were included in this study. Clinical variables were compared at initial presentation and over the course of follow-up. Black case-control pairs and white case-control pairs had similar characteristics at presentation, including cup-to-disc ratio and number of glaucoma medications. However, over the course of follow-up, black cases underwent significantly more glaucoma surgeries than matched controls (2.4 versus 1.2, p =0.001), whereas white cases and controls had no significant difference in glaucoma operations (0.9 versus 0.6, p =0.139). Our analysis found that glaucoma surgery is associated with blindness in black patients (odds ratio [OR] 1.6, 95% CI 1.1-2.2) but not in white patients (OR 1.5, 95% CI 0.7-3.2). Black and white case-control pairs with POAG shared similar risk factors for blindness at presentation. However, over the follow-up period, black cases required significantly more glaucoma surgeries compared to black controls, whereas there was no significant difference in surgery between white cases and controls. There was no difference in medication changes in either case-control set.

  8. Oral lysine clonixinate in the acute treatment of migraine: a double-blind placebo-controlled study

    OpenAIRE

    Krymchantowski,Abouch V.; Barbosa,Jackeline S.; Cheim,Celia; Alves,Luiz A.

    2001-01-01

    Several oral nonsteroidal anti-inflammatory drugs (NSAIDs) are effective to treat migraine attacks. Lysine clonixinate (LC) is a NSAID derived from nicotinic acid that has proven to be effective in various pain syndromes such as renal colic and muscular pain. The aim of this double-blind, placebo-controlled study was to evaluate the efficacy of oral LC compared to placebo in the acute treatment of migraine. Sixty four patients with the diagnosis of migraine, according to the IHS criteria, wer...

  9. A randomized, double-blind, placebo-controlled study of oral antioxidant supplement therapy in patients with dry eye syndrome

    OpenAIRE

    Huang, Jehn-Yu; Yeh, Po-Ting; Hou, Yu-Chih

    2016-01-01

    Jehn-Yu Huang, Po-Ting Yeh, Yu-Chih Hou Department of Ophthalmology, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan Purpose: To evaluate the efficacy of oral antioxidant supplementation in the treatment of patients with dry eye syndrome (DES). Methods: A prospective, randomized, double-blinded study compared the effects of an antioxidant supplement (containing anthocyanosides, astaxanthin, vitamins A, C, and E, and several herbal extract...

  10. Minocycline versus co-trimoxazole in chancroid : A double-blind randomised study

    Directory of Open Access Journals (Sweden)

    Oberoi C

    1994-01-01

    Full Text Available This double-blind randomised parallel-group study comparing the efficacy and side effects of minocycline with that of cotrimoxazole in chancroid, had 56 analysable cases, 28 in each group. All admissible cases were assessed clinically on a scale of 0 to 3 for number and size of ulcers, pain, discharge, surrounding erythema and bubo. Each drug individually showed significant improvement in all clinical parameters. Minocycline showed significantly better improvement than cotrimoxazole in all parameters. Minocycline had 43% cure rate, and no failures, against 36% cure and 25% failure for cotrimoxazole. Both the drug were well tolerated. We conclude that minocycline is a superior alternative to cotrimoxazole in the therapy of chancroid.

  11. Side-effects in ascending cervical myelography using iopamidol and metrizamide - a double blind study

    International Nuclear Information System (INIS)

    Bockenheimer, S.; Eichenlaub, H.

    1986-01-01

    A double blind study was performed to examine the side-effects of Metrizamide (group 1) and of Jopamidol (group 2) in ascending cervical myelography. Both groups were compared to a control group (group 3) comprising patients who had undergone lumbar puncture only. EEG was taken of the patients in groups 1 and 2 before as well as 6 and 24 h after intervention. Side-effects were collected by means of a questionnaire. Response time, concentration, memory and mood were examined psychometrically. Training effects or defensive attitudes in the multiple test examinations were checked against another control group of patients (group 4) which had no myelographic nor lumbar-puncture-induced impairment. Statistical findings corroborated our clinical impression that side-effects occurred after Metrizamide administration at a more than simply random rate. (orig.) [de

  12. The Assessment of Cognitive Development in Blind Infants and Preschoolers.

    Science.gov (United States)

    Brambring, M.; Troster, H.

    1994-01-01

    This study evaluated the Bielefeld Developmental Test for Blind Infants and Preschoolers by comparing cognitive performance of blind and sighted children (ages three and four). Results indicated that even this test (with "blind-neutral" items) did not permit a fair comparative assessment, though it did prove suitable for within-group…

  13. The dual trigger study: Rationale and study design of a prospective double-blind randomized clinical trial comparing pregnancy rates after co-administration of low dose hCG at the time of GnRH agonist trigger or 35 h later for the prevention of OHSS

    Directory of Open Access Journals (Sweden)

    Daniel Griffin

    2017-12-01

    Full Text Available Ovarian hyperstimulation syndrome (OHSS is an iatrogenic complication of controlled ovarian stimulation. The use of gonadotropin releasing hormone (GnRH agonist for the trigger of oocyte maturation is effective in the prevention of OHSS although it may result in a lower pregnancy rate. The use of adjuvant low dose human chorionic gonadotropin (hCG at the time of trigger or at the time of oocyte retrieval may improve pregnancy rates. The goal of this dual trigger study is to evaluate the safety and efficacy of the use of low dose hCG administered at the time of GnRH agonist trigger or 35 h later as well as the potential impact on pregnancy rates. The population will consist of 82 women undergoing IVF treatment who are at risk of developing OHSS. This study will be a single center prospective randomized double-blind placebo controlled trial. The randomization schedule will be administered by the Investigational Drug Services of the University. After controlled ovarian stimulation, induction of oocyte maturation will be achieved using a GnRH agonist and patients will be randomized to receive either low dose hCG 1000 IU at the time of trigger and placebo at oocyte retrieval (Study group or placebo at the time of trigger and hCG 1500 IU at the time of oocyte retrieval (Control group. The main outcomes will be live birth rates and incidence of OHSS. Two ancillary studies will include a quality of life survey and serum assessment of independent corpus luteum function.

  14. Mitochondrial dysfunction in the gastrointestinal mucosa of children with autism: A blinded case-control study.

    Directory of Open Access Journals (Sweden)

    Shannon Rose

    Full Text Available Gastrointestinal (GI symptoms are prevalent in autism spectrum disorder (ASD but the pathophysiology is poorly understood. Imbalances in the enteric microbiome have been associated with ASD and can cause GI dysfunction potentially through disruption of mitochondrial function as microbiome metabolites modulate mitochondrial function and mitochondrial dysfunction is highly associated with GI symptoms. In this study, we compared mitochondrial function in rectal and cecum biopsies under the assumption that certain microbiome metabolites, such as butyrate and propionic acid, are more abundant in the cecum as compared to the rectum. Rectal and cecum mucosal biopsies were collected during elective diagnostic colonoscopy. Using a single-blind case-control design, complex I and IV and citrate synthase activities and complex I-V protein quantity from 10 children with ASD, 10 children with Crohn's disease and 10 neurotypical children with nonspecific GI complaints were measured. The protein for all complexes, except complex II, in the cecum as compared to the rectum was significantly higher in ASD samples as compared to other groups. For both rectal and cecum biopsies, ASD samples demonstrated higher complex I activity, but not complex IV or citrate synthase activity, compared to other groups. Mitochondrial function in the gut mucosa from children with ASD was found to be significantly different than other groups who manifested similar GI symptomatology suggesting a unique pathophysiology for GI symptoms in children with ASD. Abnormalities localized to the cecum suggest a role for imbalances in the microbiome, potentially in the production of butyrate, in children with ASD.

  15. Visual cortex and auditory cortex activation in early binocularly blind macaques: A BOLD-fMRI study using auditory stimuli.

    Science.gov (United States)

    Wang, Rong; Wu, Lingjie; Tang, Zuohua; Sun, Xinghuai; Feng, Xiaoyuan; Tang, Weijun; Qian, Wen; Wang, Jie; Jin, Lixin; Zhong, Yufeng; Xiao, Zebin

    2017-04-15

    Cross-modal plasticity within the visual and auditory cortices of early binocularly blind macaques is not well studied. In this study, four healthy neonatal macaques were assigned to group A (control group) or group B (binocularly blind group). Sixteen months later, blood oxygenation level-dependent functional imaging (BOLD-fMRI) was conducted to examine the activation in the visual and auditory cortices of each macaque while being tested using pure tones as auditory stimuli. The changes in the BOLD response in the visual and auditory cortices of all macaques were compared with immunofluorescence staining findings. Compared with group A, greater BOLD activity was observed in the bilateral visual cortices of group B, and this effect was particularly obvious in the right visual cortex. In addition, more activated volumes were found in the bilateral auditory cortices of group B than of group A, especially in the right auditory cortex. These findings were consistent with the fact that there were more c-Fos-positive cells in the bilateral visual and auditory cortices of group B compared with group A (p visual cortices of binocularly blind macaques can be reorganized to process auditory stimuli after visual deprivation, and this effect is more obvious in the right than the left visual cortex. These results indicate the establishment of cross-modal plasticity within the visual and auditory cortices. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  16. Simulation Study of Effects of the Blind Deconvolution on Ultrasound Image

    Science.gov (United States)

    He, Xingwu; You, Junchen

    2018-03-01

    Ultrasonic image restoration is an essential subject in Medical Ultrasound Imaging. However, without enough and precise system knowledge, some traditional image restoration methods based on the system prior knowledge often fail to improve the image quality. In this paper, we use the simulated ultrasound image to find the effectiveness of the blind deconvolution method for ultrasound image restoration. Experimental results demonstrate that the blind deconvolution method can be applied to the ultrasound image restoration and achieve the satisfactory restoration results without the precise prior knowledge, compared with the traditional image restoration method. And with the inaccurate small initial PSF, the results shows blind deconvolution could improve the overall image quality of ultrasound images, like much better SNR and image resolution, and also show the time consumption of these methods. it has no significant increasing on GPU platform.

  17. 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".

  18. Alterations in right posterior hippocampus in early blind individuals

    DEFF Research Database (Denmark)

    Chebat, Daniel-Robert; Chen, Jan-Kai; Schneider, Fabien

    2007-01-01

    This study compares hippocampal volumes of early blind and sex/age-matched sighted controls through volumetric and localization analyses. Early blind individuals showed a significantly smaller right posterior hippocampus compared with controls. No differences in total hippocampal volumes were fou...... of the posterior hippocampus in early blind individuals suggests the implication of this region in visual spatial memory. Udgivelsesdato: 2007-Mar-5......This study compares hippocampal volumes of early blind and sex/age-matched sighted controls through volumetric and localization analyses. Early blind individuals showed a significantly smaller right posterior hippocampus compared with controls. No differences in total hippocampal volumes were found...

  19. Comparative efficacy of combination of 1 L polyethylene glycol, castor oil and ascorbic acid versus 2 L polyethylene glycol plus castor oil versus 3 L polyethylene glycol for colon cleansing before colonoscopy: Study protocol of a randomized, double-blind, single-center study.

    Science.gov (United States)

    Tian, Xu; Chen, Wei-Qing; Liu, Xiao-Ling; Chen, Hui; Liu, Bang-Lun; Pi, Yuan-Ping

    2018-04-01

    Colonoscopy has been regarded as an important method of early diagnosing and treating gastrointestinal lesions; however adequate bowel preparation is critical one of many factors needed for successful colonoscopy. Although several modified or novel regimes have been developed, desired quality of bowel preparation has not yet been generated. Scattered evidences revealed that castor oil may have potential of effectively cleansing colon. It is noted that, however, prospective trial of exploring the value of castor oil in preparing bowel before colonoscopy is lacking. The aims of this study are to test the hypotheses that low dose castor oil (30 mL) may enhance potential of polyethylene glycol (PEG) and combination of low castor oil and ascorbic acid may halve the volume of PEG.This is a randomized, double-blind (endoscopist and assessor), single center trial with three-arm design. We will randomly assign 282 adult patients (≥18 years but castor oil or combination of 1 L PEG, 30 mL castor oil and 5 g ascorbic acid. The bowel preparation quality based on Boston Bowel Preparation Scale (BBPS) is the primary outcome. The secondary outcomes include the first defecation time, total number of defecation, time of cecal intubation, detection rate of polyp and adenoma, willing to repeat the same regime, tolerance to regime, and adverse events.The study protocol has been approved by the Clinical Research Ethics Committees of Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer Hospital & Chongqing Cancer Center (2017[107]). The results from this trial will be submitted for publication in peer-reviewed journals, and will be presented at national and international conferences.

  20. Information Communication Technology to support and include Blind students in a school for all An Interview study of teachers and students’ experiences with inclusion and ICT support to blind students

    OpenAIRE

    Rony, Mahbubur Rahman

    2017-01-01

    The topic of this is this study is how blind students and teachers experiences Information Communication Technology as a tool to support and include blind students in a school for all. The study investigates how Information and Communication Technologies (ICT) enables blind students to adjust into non-special schools. The research method used to collect data is interview. The goal is to get insight to teachers and students’ experiences with inclusion and ICT as a tool to support blind student...

  1. Combined therapy with levothyroxine and liothyronine in two ratios, compared with levothyroxine monotherapy in primary hypothyroidism: a double-blind, randomized, controlled clinical trial

    NARCIS (Netherlands)

    Appelhof, Bente C.; Fliers, Eric; Wekking, Ellie M.; Schene, Aart H.; Huyser, Jochanan; Tijssen, Jan G. P.; Endert, Erik; van Weert, Henk C. P. M.; Wiersinga, Wilmar M.

    2005-01-01

    Controversy remains about the value of combined treatment with levothyroxine (LT4) and liothyronine (LT3), compared with LT4 alone in primary hypothyroidism. We compared combined treatment with LT4 and LT3 in a ratio of 5: 1 or 10: 1 with LT4 monotherapy. We conducted a double-blind, randomized,

  2. Transient monocular blindness and the risk of vascular complications according to subtype : a prospective cohort study

    NARCIS (Netherlands)

    Volkers, Eline J; Donders, Richard C J M; Koudstaal, Peter J; van Gijn, Jan; Algra, Ale; Jaap Kappelle, L

    Patients with transient monocular blindness (TMB) can present with many different symptoms, and diagnosis is usually based on the history alone. In this study, we assessed the risk of vascular complications according to different characteristics of TMB. We prospectively studied 341 consecutive

  3. Transient monocular blindness and the risk of vascular complications according to subtype: a prospective cohort study

    NARCIS (Netherlands)

    Volkers, E.J. (Eline J.); R. Donders (Rogier); P.J. Koudstaal (Peter Jan); van Gijn, J. (Jan); A. Algra (Ale); L. Jaap Kappelle

    2016-01-01

    textabstractPatients with transient monocular blindness (TMB) can present with many different symptoms, and diagnosis is usually based on the history alone. In this study, we assessed the risk of vascular complications according to different characteristics of TMB. We prospectively studied 341

  4. 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

  5. ADHD and EEG-neurofeedback: a double-blind randomized placebo-controlled feasibility study

    NARCIS (Netherlands)

    Lansbergen, M.M.; Dongen-Boomsma, M. van; Buitelaar, J.K.; Slaats-Willemse, D.I.E.

    2011-01-01

    Electroencephalography (EEG)-neurofeedback has been shown to offer therapeutic benefits to patients with attention-deficit/hyperactivity disorder (ADHD) in several, mostly uncontrolled studies. This pilot study is designed to test the feasibility and safety of using a double-blind placebo

  6. Minocycline treatment in acute stroke: an open-label, evaluator-blinded study.

    Science.gov (United States)

    Lampl, Y; Boaz, M; Gilad, R; Lorberboym, M; Dabby, R; Rapoport, A; Anca-Hershkowitz, M; Sadeh, M

    2007-10-02

    Ischemic animal model studies have shown a neuroprotective effect of minocycline. To analyze the effect of minocycline treatment in human acute ischemic stroke. We performed an open-label, evaluator-blinded study. Minocycline at a dosage of 200 mg was administered orally for 5 days. The therapeutic window of time was 6 to 24 hours after onset of stroke. Data from NIH Stroke Scale (NIHSS), modified Rankin Scale (mRS), and Barthel Index (BI) were evaluated. The primary objective was to compare changes from baseline to day 90 in NIHSS in the minocycline group vs placebo. One hundred fifty-two patients were included in the study. Seventy-four patients received minocycline treatment, and 77 received placebo. NIHSS and mRS were significantly lower and BI scores were significantly higher in minocycline-treated patients. This pattern was already apparent on day 7 and day 30 of follow-up. Deaths, myocardial infarctions, recurrent strokes, and hemorrhagic transformations during follow-up did not differ by treatment group. Patients with acute stroke had significantly better outcome with minocycline treatment compared with placebo. The findings suggest a potential benefit of minocycline in acute ischemic stroke.

  7. Blinded by the White: A Comparative Analysis of Jury Challenges on Racial Grounds

    Directory of Open Access Journals (Sweden)

    Thalia Anthony

    2017-08-01

    Full Text Available Indigenous peoples in Australia, the United States and Canada are significantly overrepresented as defendants in criminal trials and yet vastly underrepresented on juries in criminal trials. This means that all-white juries mostly determine the guilt of Indigenous defendants or white defendants responsible for harming Indigenous victims. In this article, we explore cases in which Indigenous defendants have perceived that an all-white jury’s prejudice against Indigenous people would prevent them receiving a fair trial. It focuses on Indigenous defendants (often facing charges in relation to protesting against white racism challenging the array of all-white juries. Across these cases, Australian courts rely on formal notions of fairness in jury selection to dismiss the Indigenous defendant’s perception of bias and foreclose an inquiry into the potential prejudices of white jurors. We compare the Australian judicial ‘colour-blindness’ towards all-white juries with that of the United States and Canada. We argue that the tendency for courts in the United States and Canada to question jurors on their biases provides useful lessons for Australian judiciaries, including in relation to the impending trials of Indigenous defendants in Kalgoorlie, Western Australia, accused of committing crimes in response to white racist violence. Nonetheless, across all jurisdictions where there is a challenge to the array based on racial composition, courts consistently uphold all-white juries. We suggest that the judicial view of the racial neutrality of white jury selection misapprehends the substantive biases in jury selection and the injustice perceived by defendants in having a white jury adjudicate an alleged crime that is committed in circumstances involving protest against white prejudice.

  8. Sedation with midazolam for voiding cystourethrography in children: a randomised double-blind study

    International Nuclear Information System (INIS)

    Stokland, E.; Jacobsson, B.; Ljung, B.; Andreasson, S.; Jodal, U.

    2003-01-01

    Background: Sedation with midazolam facilitates the performance of diagnostic procedures in children, including voiding cystourethrography (VCUG). However, the influence of sedation on voiding and imaging results have not been adequately evaluated. Objective: Midazolam and placebo were compared to assess discomfort during VCUG and to evaluate if sedation influenced the outcome of the examination. Materials and methods: The study was prospective, randomized and double-blind, and included 95 children, 48 in the midazolam group (median age 2.2 years) and 47 in the placebo group (median age 3.2 years). The evaluation included the child's/parent's experience of the VCUG, as well as the examination results. Results: The children/parents in the midazolam group experienced the VCUG as less distressing compared to those in the placebo group (P < 0.001). Forty-six of 48 children sedated with midazolam could void during the imaging procedure compared to 38 of 47 children given placebo (NS). There was no difference in frequency or grade of vesicoureteric reflux or bladder emptying between the groups. Conclusions: When sedation is required to perform VCUG in children, midazolam can be used without negative effect on the outcome of the examination. (orig.)

  9. Baseline risk factors for incidence of blindness in a South Indian population: the chennai eye disease incidence study.

    Science.gov (United States)

    Vijaya, Lingam; Asokan, Rashima; Panday, Manish; Choudhari, Nikhil S; Ramesh, Sathyamangalam Ve; Velumuri, Lokapavani; Boddupalli, Sachi Devi; Sunil, Govindan T; George, Ronnie

    2014-08-07

    To report the baseline risk factors and causes for incident blindness. Six years after the baseline study, 4419 subjects from the cohort underwent a detailed examination at the base hospital. Incident blindness was defined by World Health Organization criteria as visual acuity of less than 6/120 (3/60) and/or a visual field of less than 10° in the better-seeing eye at the 6-year follow-up, provided that the eye had a visual acuity of better than or equal to 6/120 (3/60) and visual field greater than 10° at baseline. For incident monocular blindness, both eyes should have visual acuity of more than 6/120 (3/60) at baseline and developed visual acuity of less than 6/120 (3/60) in one eye at 6-year follow-up. For incident blindness, 21 participants (0.48%, 95% confidence interval [CI], 0.3-0.7) became blind; significant baseline risk factors were increasing age (P = 0.001), smokeless tobacco use (P blindness was found in 132 participants (3.8%, 95% CI, 3.7-3.8); it was significantly more (P blindness and monocular blindness. No history of cataract surgery was a risk factor for blindness and a protective factor for monocular blindness. Copyright 2014 The Association for Research in Vision and Ophthalmology, Inc.

  10. [Comparative studies of face recognition].

    Science.gov (United States)

    Kawai, Nobuyuki

    2012-07-01

    Every human being is proficient in face recognition. However, the reason for and the manner in which humans have attained such an ability remain unknown. These questions can be best answered-through comparative studies of face recognition in non-human animals. Studies in both primates and non-primates show that not only primates, but also non-primates possess the ability to extract information from their conspecifics and from human experimenters. Neural specialization for face recognition is shared with mammals in distant taxa, suggesting that face recognition evolved earlier than the emergence of mammals. A recent study indicated that a social insect, the golden paper wasp, can distinguish their conspecific faces, whereas a closely related species, which has a less complex social lifestyle with just one queen ruling a nest of underlings, did not show strong face recognition for their conspecifics. Social complexity and the need to differentiate between one another likely led humans to evolve their face recognition abilities.

  11. Diagnostic performance of dual-energy contrast-enhanced subtracted mammography in dense breasts compared to mammography alone: interobserver blind-reading analysis.

    Science.gov (United States)

    Cheung, Yun-Chung; Lin, Yu-Ching; Wan, Yung-Liang; Yeow, Kee-Min; Huang, Pei-Chin; Lo, Yung-Feng; Tsai, Hsiu-Pei; Ueng, Shir-Hwa; Chang, Chee-Jen

    2014-10-01

    To analyse the accuracy of dual-energy contrast-enhanced spectral mammography in dense breasts in comparison with contrast-enhanced subtracted mammography (CESM) and conventional mammography (Mx). CESM cases of dense breasts with histological proof were evaluated in the present study. Four radiologists with varying experience in mammography interpretation blindly read Mx first, followed by CESM. The diagnostic profiles, consistency and learning curve were analysed statistically. One hundred lesions (28 benign and 72 breast malignancies) in 89 females were analysed. Use of CESM improved the cancer diagnosis by 21.2 % in sensitivity (71.5 % to 92.7 %), by 16.1 % in specificity (51.8 % to 67.9 %) and by 19.8 % in accuracy (65.9 % to 85.8 %) compared with Mx. The interobserver diagnostic consistency was markedly higher using CESM than using Mx alone (0.6235 vs. 0.3869 using the kappa ratio). The probability of a correct prediction was elevated from 80 % to 90 % after 75 consecutive case readings. CESM provided additional information with consistent improvement of the cancer diagnosis in dense breasts compared to Mx alone. The prediction of the diagnosis could be improved by the interpretation of a significant number of cases in the presence of 6 % benign contrast enhancement in this study. • DE-CESM improves the cancer diagnosis in dense breasts compared with mammography. • DE-CESM shows greater consistency than mammography alone by interobserver blind reading. • Diagnostic improvement of DE-CESM is independent of the mammographic reading experience.

  12. The Tilburg double blind randomised controlled trial comparing inguinal hernia repair according to Lichtenstein and the transinguinal preperitoneal technique

    Directory of Open Access Journals (Sweden)

    Gerritsen Pieter G

    2009-09-01

    Full Text Available Abstract Background Anterior open treatment of the inguinal hernia with a tension free mesh has reduced the incidence of recurrence and direct postoperative pain. The Lichtenstein procedure rules nowadays as reference technique for hernia treatment. Not recurrences but chronic pain is the main postoperative complication in inguinal hernia repair after Lichtenstein's technique. Preliminary experiences with a soft mesh placed in the preperitoneal space showed good results and less chronic pain. Methods The TULIP is a double-blind randomised controlled trial in which 300 patients will be randomly allocated to anterior inguinal hernia repair according to Lichtenstein or the transinguinal preperitoneal technique with soft mesh. All unilateral primary inguinal hernia patients eligible for operation who meet inclusion criteria will be invited to participate in this trial. The primary endpoint will be direct postoperative- and chronic pain. Secondary endpoints are operation time, postoperative complications, hospital stay, costs, return to daily activities (e.g. work and recurrence. Both groups will be evaluated. Success rate of hernia repair and complications will be measured as safeguard for quality. To demonstrate that inguinal hernia repair according to the transinguinal preperitoneal (TIPP technique reduces postoperative pain to Discussion The TULIP trial is aimed to show a reduction in postoperative chronic pain after anterior hernia repair according to the transinguinal preperitoneal (TIPP technique, compared to Lichtenstein. In our hypothesis the TIPP technique reduces chronic pain compared to Lichtenstein. Trial registration ISRCTN 93798494

  13. ROPIVACAINE VERSUS LIDOCAINE FOR EPISIOTOMY-A RANDOMISED DOUBLE BLIND STUDY

    Directory of Open Access Journals (Sweden)

    Pushpalatha Nagaraj

    2017-04-01

    Full Text Available BACKGROUND Episiotomy is a most common surgical procedure for parturients during vaginal delivery. The problem encountered with episiotomy is pain, which is maximum during first 24 hours and may be severe enough to disturb the puerperium. This study aims to compare analgesic efficacy of analgesics, ropivacaine and lidocaine for perineal infiltration during episiotomy. MATERIALS AND METHODS We conducted a randomised double blind study for a period one year from August 2013 in a tertiary hospital. 100 parturients were included. RESULTS Ropivacaine 0.75% compared to lidocaine 2% did not show any statistical significant changes at suturing and after 4 hours; however, there were great statistically significant changes in VAS scores after 8 hours, 12 hours, 24 hours of episiotomy suturing. Ropivacaine group did not require systemic analgesics for 24 hours, but lidocaine group required systemic analgesics after 4 hours of suturing. Both groups (Ropivacaine and Lidocaine did not have any adverse effects. CONCLUSION Ropivacaine can be used safely for episiotomy wound infiltration thereby reducing the need for systemic analgesia.

  14. A single dose desensitization for summer hay fever. Results of a double blind study-1988.

    Science.gov (United States)

    Fell, P; Brostoff, J

    1990-01-01

    A new type of desensitising vaccine, enzyme potentiated was subjected to a double-blind randomised study during the hay fever season. The vaccine is a convenient single injection given in March and the results show good protection throughout the grass pollen season.

  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. Building automation and perceived control : a field study on motorized exterior blinds in Dutch offices

    NARCIS (Netherlands)

    Meerbeek, B.W.; te Kulve, Marije; Gritti, T.; Aarts, M.P.J.; Loenen, van E.J.; Aarts, E.H.L.

    2014-01-01

    As a result of the technological advances and increasing focus on energy efficient buildings, simple forms of building automation including automatic motorized blinds systems found their ways into today's office environments. In a five-month field study, qualitative and quantitative methods were

  17. Sucralfate versus cimetidine in reflux esophagitis. A single-blind multicenter study

    NARCIS (Netherlands)

    Hameeteman, W.; v d Boomgaard, D. M.; Dekker, W.; Schrijver, M.; Wesdorp, I. C.; Tytgat, G. N.

    1987-01-01

    A single-blind randomized multicenter study was performed in 42 patients with endoscopically documented reflux esophagitis. Patients were randomly given 400 mg cimetidine q.i.d. or a suspension of 1 g sucralfate q.i.d. for a period of 8 weeks. Forty patients were evaluated after 8 weeks. Symptomatic

  18. 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).

  19. Mefloquine prophylaxis prevents malaria during pregnancy: a double-blind, placebo-controlled study

    NARCIS (Netherlands)

    Nosten, F.; ter Kuile, F.; Maelankiri, L.; Chongsuphajaisiddhi, T.; Nopdonrattakoon, L.; Tangkitchot, S.; Boudreau, E.; Bunnag, D.; White, N. J.

    1994-01-01

    A double-blind, placebo-controlled study of mefloquine antimalarial prophylaxis in pregnancy (> 20 weeks of gestation) was conducted in 339 Karen women living in an area of multidrug-resistant malaria transmission on the Thai-Burmese border. Mefloquine gave > or = 86% (95% confidence interval [CI],

  20. Human norovirus inactivation in oysters by high hydrostatic pressure processing: A randomized double-blinded study

    Science.gov (United States)

    This randomized, double-blinded, clinical trial assessed the effect of high hydrostatic pressure processing (HPP) on genogroup I.1 human norovirus (HuNoV) inactivation in virus-seeded oysters when ingested by subjects. The safety and efficacy of HPP treatments were assessed in three study phases wi...

  1. Lived Experience of Self-Care in Blind Individuals: A Phenomenological Study

    Directory of Open Access Journals (Sweden)

    Mahmood Shamshir i

    2016-06-01

    Full Text Available Background and Objectives: Blindness is a serious condition, which can affect mental balance and general organized personality of blind person. This study was carried out with the purpose of explaining the lived experience of self-care in blind individuals. Methods: in this study, interpretive phenomenology was used to conduct the study. Through a purposeful sampling, 8 in-depth semi structured interviews were performed for 8 participants, which their duration was between 50-120 minutes. The method introduced by van Manen was used to perform the research and extract the concepts. Results: Analysis of the data led to three concepts, including “Being through discipline”, “independent through discipline”, and “protection of discipline”, which finally caused the appearance of the main concept, “self-care through a disciplined life”. Conclusion: Blind individuals benefit from a disciplined lifestyle to have an independent life, and also expect this kind of discipline from others. Therefore, it is necessary that family members and health care providers consider the concept of disciplined life.

  2. Does a mineral wristband affect balance? A randomized, controlled, double-blind study.

    Science.gov (United States)

    Hansson, Eva Ekvall; Beckman, Anders; Persson, Liselott

    2015-06-26

    Having good balance is a facilitating factor in the performance of everyday activities. Good balance is also essential in various sport activities in order to both get results and prevent injury. A common measure of balance is postural sway, which can be measured both antero-posteriorly and medio-laterally. There are several companies marketing wristbands whose intended function is to improve balance, strength and flexibility. Randomized controlled trials have shown that wristbands with holograms have no effect on balance but studies on wristbands with minerals seem to be lacking. The aim of this study was to investigate if the mineral wristband had any effect on postural sway in a group of healthy individuals. Randomized, controlled, double-blind study. The study group consisted of 40 healthy persons. Postural sway was measured antero-posteriorly and medio-laterally on a force plate, to compare: the mineral wristband, a placebo wristband, and without any wristband. The measurements were performed for 30 s, in four situations: with open eyes and closed eyes, standing on a firm surface and on foam. Analyses were made with multilevel technique. The use of wristband with or without minerals did not alter postural sway. Closed eyes and standing on foam both prolonged the dependent measurement, irrespective if it was medio-lateral or antero-posterior. Wearing any wristband (mineral or placebo) gave a small (0.22-0.36 mm/s) but not statistically significant reduction of postural sway compared to not wearing wristband. This study showed no effect on postural sway by using the mineral wristband, compared with a placebo wristband or no wristband. Wearing any wristband at all (mineral or placebo) gave a small but not statistically significant reduction in postural sway, probably caused by sensory input.

  3. Visual and Motor Recovery After "Cognitive Therapeutic Exercises" in Cortical Blindness: A Case Study.

    Science.gov (United States)

    De Patre, Daniele; Van de Winckel, Ann; Panté, Franca; Rizzello, Carla; Zernitz, Marina; Mansour, Mariam; Zordan, Lara; Zeffiro, Thomas A; OʼConnor, Erin E; Bisson, Teresa; Lupi, Andrea; Perfetti, Carlo

    2017-07-01

    Spontaneous visual recovery is rare after cortical blindness. While visual rehabilitation may improve performance, no visual therapy has been widely adopted, as clinical outcomes are variable and rarely translate into improvements in activities of daily living (ADLs). We explored the potential value of a novel rehabilitation approach "cognitive therapeutic exercises" for cortical blindness. The subject of this case study was 48-year-old woman with cortical blindness and tetraplegia after cardiac arrest. Prior to the intervention, she was dependent in ADLs and poorly distinguished shapes and colors after 19 months of standard visual and motor rehabilitation. Computed tomographic images soon after symptom onset demonstrated acute infarcts in both occipital cortices. The subject underwent 8 months of intensive rehabilitation with "cognitive therapeutic exercises" consisting of discrimination exercises correlating sensory and visual information. Visual fields increased; object recognition improved; it became possible to watch television; voluntary arm movements improved in accuracy and smoothness; walking improved; and ADL independence and self-reliance increased. Subtraction of neuroimaging acquired before and after rehabilitation showed that focal glucose metabolism increases bilaterally in the occipital poles. This study demonstrates feasibility of "cognitive therapeutic exercises" in an individual with cortical blindness, who experienced impressive visual and sensorimotor recovery, with marked ADL improvement, more than 2 years after ischemic cortical damage.Video Abstract available for additional insights from the authors (see Video, Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A173).

  4. 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…

  5. A single-blind controlled study of electrocautery and ultrasonic scalpel smoke plumes in laparoscopic surgery.

    Science.gov (United States)

    Fitzgerald, J Edward F; Malik, Momin; Ahmed, Irfan

    2012-02-01

    Surgical smoke containing potentially carcinogenic and irritant chemicals is an inevitable consequence of intraoperative energized dissection. Different energized dissection methods have not been compared directly in human laparoscopic surgery or against commonly encountered pollutants. This study undertook an analysis of carcinogenic and irritant volatile hydrocarbon concentrations in electrocautery and ultrasonic scalpel plumes compared with cigarette smoke and urban city air control samples. Once ethical approval was obtained, gas samples were aspirated from the peritoneal cavity after human laparoscopic intraabdominal surgery solely using either electrocautery or ultrasonic scalpels. All were adsorbed in Tenax tubes and concentrations of carcinogenic or irritant volatile hydrocarbons measured by gas chromatography. The results were compared with cigarette smoke and urban city air control samples. The analyzing laboratory was blinded to sample origin. A total of 10 patients consented to intraoperative gas sampling in which only one method of energized dissection was used. Six carcinogenic or irritant hydrocarbons (benzene, ethylbenzene, styrene, toluene, heptene, and methylpropene) were identified in one or more samples. With the exception of styrene (P = 0.016), a nonsignificant trend toward lower hydrocarbon concentrations was observed with ultrasonic scalpel use. Ultrasonic scalpel plumes had significantly lower hydrocarbon concentrations than cigarette smoke, with the exception of methylpropene (P = 0.332). No significant difference was observed with city air. Electrocautery samples contained significantly lower hydrocarbon concentrations than cigarette smoke, with the exception of toluene (P = 0.117) and methyl propene (P = 0.914). Except for toluene (P = 0.028), city air showed no significant difference. Both electrocautery and ultrasonic dissection are associated with significantly lower concentrations of the most commonly detected carcinogenic and

  6. Prevalence and causes of low vision and blindness in an elderly population in Nepal: the Bhaktapur retina study.

    Science.gov (United States)

    Thapa, Raba; Bajimaya, Sanyam; Paudyal, Govinda; Khanal, Shankar; Tan, Stevie; Thapa, Suman S; van Rens, G H M B

    2018-02-13

    This study aims to explore the prevalence and causes of low vision and blindness focused on retinal disease in a population above 60 years in Nepal. Two thousand one hundred subjects were enrolled in a population-based cross-sectional study. History, presenting and best corrected visual acuity after subjective refraction, anterior and posterior segment examinations was obtained in detail. Among the total subjects, 1860 (88.57%) had complete information. Age varies from 60 to 95 (mean age: 69.64 ± 7.31) years. Low vision and blindness in both eyes at presentation was found in 984 (52.90%, 95% confidence interval (CI): 50.60-55.19) and 36 (1.94%, 95% CI: 1.35-2.66) subjects respectively. After best correction, bilateral low vision and blindness was found in 426 (22.92%, 95% CI: 21.01-24.88), and 30 (1.61%, 95% CI: 0.10-2.30) subjects respectively. As compared to 60-69 years old, risk of visual impairment was four times higher (95% CI:3.26-5.58) in the 70-79 year olds and 14 times higher (95% CI: 9.72-19.73) in the age group 80 years and above. Major causes of bilateral low vision were cataract (68.07%), followed by retinal disorders (28.64%), and for blindness; retinal disorders (46.66%), followed by cataract (43.33%). Illiteracy was significantly associated with visual impairment. Among the elderly population, prevalence of visual impairment was high. Refractive error, cataract and retinal disorders were the major cause of low vision. Screening the population at the age 60 years and above, focused on cataract and posterior segment diseases, providing glasses and timely referral can help reduce visual impairment.

  7. Efficacy of peloid therapy in patients with chronic lateral epicondylitis: a randomized, controlled, single blind study

    Science.gov (United States)

    Ökmen, Burcu Metin; Eröksüz, Rıza; Altan, Lale; Aksoy, Meliha Kasapoğlu

    2017-11-01

    The aim of this study was to assess the effect of peloid on pain, functionality, daily life activities, and quality of life of lateral epicondylitis (LE) patients. In this randomized, controlled, single-blind study, 75 patients who were diagnosed with chronic LE were enrolled to the study. Patients were randomized into two groups using the random number table. The patients in the first group (group 1) ( n = 33), were given lateral epicondylitis band (LEB) (during the day for 6 weeks) + peloid therapy (five consecutive days a week for 2 weeks), and the second group (group 2) ( n = 32), received LEB treatment alone. The patients were assessed by using Patient Rated Tennis Elbow Evaluation (PRTEE) and Nottingham Health Profile (NHP). The data were obtained before treatment (W0), immediately after treatment (W2), and 1 month after treatment (W6). In analysis of the collected data, the Wilcoxon signed rank test for intra-group comparisons and Mann-Whitney U test for comparisons between groups were used. Both in groups 1 and 2, there was a statistically significant improvement in all the evaluation parameters at W2 and W6 when compared to W0 ( p 0.05), a statistically significant difference was found in favor of group 1 for all the evaluation parameters at W6 ( p < 0.05). Our results have shown that peloid treatment could be effective in providing improvement in pain relief, function, daily life activities, and quality of life in LE patients.

  8. Tissue resonance interaction accurately detects colon lesions: A double-blind pilot study.

    Science.gov (United States)

    Dore, Maria P; Tufano, Marcello O; Pes, Giovanni M; Cuccu, Marianna; Farina, Valentina; Manca, Alessandra; Graham, David Y

    2015-07-07

    To investigated the performance of the tissue resonance interaction method (TRIM) for the non-invasive detection of colon lesions. We performed a prospective single-center blinded pilot study of consecutive adults undergoing colonoscopy at the University Hospital in Sassari, Italy. Before patients underwent colonoscopy, they were examined by the TRIMprobe which detects differences in electromagnetic properties between pathological and normal tissues. All patients had completed the polyethylene glycol-containing bowel prep for the colonoscopy procedure before being screened. During the procedure the subjects remained fully dressed. A hand-held probe was moved over the abdomen and variations in electromagnetic signals were recorded for 3 spectral lines (462-465 MHz, 930 MHz, and 1395 MHz). A single investigator, blind to any clinical information, performed the test using the TRIMprob system. Abnormal signals were identified and recorded as malignant or benign (adenoma or hyperplastic polyps). Findings were compared with those from colonoscopy with histologic confirmation. Statistical analysis was performed by χ(2) test. A total of 305 consecutive patients fulfilling the inclusion criteria were enrolled over a period of 12 months. The most frequent indication for colonoscopy was abdominal pain (33%). The TRIMprob was well accepted by all patients; none spontaneously complained about the procedure, and no adverse effects were observed. TRIM proved inaccurate for polyp detection in patients with inflammatory bowel disease (IBD) and they were excluded leaving 281 subjects (mean age 59 ± 13 years; 107 males). The TRIM detected and accurately characterized all 12 adenocarcinomas and 135/137 polyps (98.5%) including 64 adenomatous (100%) found. The method identified cancers and polyps with 98.7% sensitivity, 96.2% specificity, and 97.5% diagnostic accuracy, compared to colonoscopy and histology analyses. The positive predictive value was 96.7% and the negative predictive

  9. Randomized, Double-blind Study with Glycerol and Paraffin in Uremic Xerosis

    Science.gov (United States)

    Balaskas, Elias; Szepietowski, Jacek C.; Bessis, Didier; Ioannides, Dimitrios; Ponticelli, Claudio; Ghienne, Corinne; Taberly, Alain

    2011-01-01

    Summary Background and objectives Uremic xerosis is a bothersome condition that is poorly responsive to moisturizing and emollient therapy. Design, setting, participants, & measurements A randomized, double-blind, intraindividual (left versus right comparison), multicentric clinical study was performed on 100 patients with moderate to severe uremic xerosis for 7 days, during which the patients applied twice daily an emulsion combining glycerol and paraffin (test product) on one allocated lower leg, and the emulsion alone (comparator) on the other lower leg. This was followed by an open-labeled use of the test product on all of the xerotic areas for 49 days. The main efficacy parameter was treatment response on each lower leg, as defined by a reduction from baseline of at least two grades in a five-point clinical score on day 7. Results Among the 99 patients analyzed, the test product was highly effective with a treatment response in 72 patients (73%), whereas 44 patients (44%) responded to the comparator (P < 0.0001, intergroup analysis). This was associated with an objective reduction in the density and thickness of the scales on day 7 (P < 0.0001 compared with the comparator) and a substantial improvement of the uremic pruritus (75%) and quality of life of the patients at study end (P < 0.001, intragroup analysis). The test product was very well tolerated, with product-related local intolerance (exacerbated pruritus, local burning, or erythema) occurring in only five patients (5%). Conclusions Uremic xerosis can be managed successfully when an appropriate emollient therapy is used. PMID:21258039

  10. Sex work: a comparative study.

    Science.gov (United States)

    McCarthy, Bill; Benoit, Cecilia; Jansson, Mikael

    2014-10-01

    Explanations of adult involvement in sex work typically adopt one of two approaches. One perspective highlights a variety of negative experiences in childhood and adolescence, including physical and sexual abuse, family instability, poverty, associations with "pimps" and other exploiters, homelessness, and drug use. An alternative account recognizes that some of these factors may be involved, but underscores the contribution of more immediate circumstances, such as current economic needs, human capital, and employment opportunities. Prior research offers a limited assessment of these contrasting claims: most studies have focused exclusively on people working in the sex industry and they have not assessed the independent effects of life course variables central to these two perspectives. We add to this literature with an analysis that drew on insights from life course and life-span development theories and considered the contributions of factors from childhood, adolescence, and adulthood. Our comparative approach examined predictors of employment in sex work relative to two other low-income service or care work occupations: food and beverage serving and barbering and hairstyling. Using data from a study of almost 600 workers from two cities, one in Canada and the other in the United States, we found that both immediate circumstances and negative experiences from early life are related to current sex work involvement: childhood poverty, abuse, and family instability were independently associated with adult sex work, as were limited education and employment experience, adult drug use, and marital status.

  11. Comparison of Quality of Life and Social Skills between Students with Visual Problems (Blind and Partially Blind) and Normal Students

    OpenAIRE

    Fereshteh Kordestani; Azam Daneshfar; Davood Roustaee

    2014-01-01

    This study aimed to compare the quality of life and social skills between students who are visually impaired (blind and partially blind) and normal students. The population consisted of all students with visual problems (blind and partially blind) and normal students in secondary schools in Tehran in the academic year 2013-2014. Using a multi-stage random sampling method, 40 students were selected from each group. The SF-36s quality of life questionnaire and Foster and Inderbitzen social skil...

  12. Feature study of hysterical blindness EEG based on FastICA with combined-channel information.

    Science.gov (United States)

    Qin, Xuying; Wang, Wei; Hu, Lintao; Wang, Xu; Yuan, Xiaojie

    2015-01-01

    An appropriate feature study of hysteria electroencephalograms (EEG) would provide new insights into neural mechanisms of the disease, and also make improvements in patient diagnosis and management. The objective of this paper is to provide an explanation for what causes a particular visual loss, by associating the features of hysterical blindness EEG with brain function. An idea for the novel feature extraction for hysterical blindness EEG, utilizing combined-channel information, was applied in this paper. After channels had been combined, the sliding-window-FastICA was applied to process the combined normal EEG and hysteria EEG, respectively. Kurtosis features were calculated from the processed signals. As the comparison feature, the power spectral density of normal and hysteria EEG were computed. According to the feature analysis results, a region of brain dysfunction was located at the occipital lobe, O1 and O2. Furthermore, new abnormality was found at the parietal lobe, C3, C4, P3, and P4, that provided us with a new perspective for understanding hysterical blindness. Indicated by the kurtosis results which were consistent with brain function and the clinical diagnosis, our method was found to be a useful tool to capture features in hysterical blindness EEG.

  13. Pimecrolimus cream 1% in the treatment of intertriginous psoriasis: a double-blind, randomized study.

    Science.gov (United States)

    Gribetz, Carin; Ling, Mark; Lebwohl, Mark; Pariser, David; Draelos, Zoe; Gottlieb, Alice B; Zaias, Nardo; Chen, Diana M; Parneix-Spake, Anne; Hultsch, Thomas; Menter, Alan

    2004-11-01

    Inverse psoriasis can be difficult to treat because of the high sensitivity of intertriginous areas to cutaneous side effects, such as irritation and striae. Pimecrolimus, a well-tolerated, nonatrophogenic, skin-selective inflammatory cytokine inhibitor, has been shown to be effective in the treatment of psoriasis when applied topically under occlusion. This study evaluated the efficacy and safety of pimecrolimus cream 1% versus vehicle twice a day in the treatment of inverse psoriasis. Methods This was a double-blind, randomized, vehicle-controlled study in 57 patients with moderate to severe inverse psoriasis. Patients were evaluated using Investigator's Global Assessment of overall severity, Target Area Score, and Patient Self-Assessment. A significant between-group difference was observed early on, with 54% of the pimecrolimus group versus 21% of the vehicle group having an Investigator's Global Assessment score of 0 or 1 (clear or almost clear) at week 2 ( P = .0169). By week 8, 71% of the pimecrolimus group had an Investigator's Global Assessment score of 0 or 1. Change from baseline in Target Area Score was -2.4 (pimecrolimus group) compared with -0.7 (vehicle) at day 3 ( P < .0001). By week 8, 82% of patients using pimecrolimus scored their disease as well or completely controlled versus 41% of the vehicle group ( P = .0007). Adverse events were similar between groups. Pimecrolimus cream 1% is an effective treatment for inverse psoriasis with a rapid onset of action, and is safe and well-tolerated.

  14. Tribulus terrestris for treatment of sexual dysfunction in women: randomized double-blind placebo - controlled study

    Science.gov (United States)

    2014-01-01

    Background Tribulus terrestris as a herbal remedy has shown beneficial aphrodisiac effects in a number of animal and human experiments. This study was designed as a randomized double-blind placebo-controlled trial to assess the safety and efficacy of Tribulus terrestris in women with hypoactive sexual desire disorder during their fertile years. Sixty seven women with hypoactive sexual desire disorder were randomly assigned to Tribulus terrestris extract (7.5 mg/day) or placebo for 4 weeks. Desire, arousal, lubrication, orgasm, satisfaction, and pain were measured at baseline and after 4 weeks after the end of the treatment by using the Female Sexual Function Index (FSFI). Two groups were compared by repeated measurement ANOVA test. Results Thirty women in placebo group and thirty women in drug group completed the study. At the end of the fourth week, patients in the Tribulus terrestris group had experienced significant improvement in their total FSFI (p Tribulus terrestris may safely and effectively improve desire in women with hypoactive sexual desire disorder. Further investigation of Tribulus terrestris in women is warranted. PMID:24773615

  15. A randomized, double-blind, phase 3 study of fospropofol disodium for sedation during colonoscopy.

    Science.gov (United States)

    Cohen, Lawrence B; Cattau, Edward; Goetsch, Allen; Shah, Atul; Weber, John R; Rex, Douglas K; Kline, Jacqueline M

    2010-01-01

    This double-blind, multicenter study evaluated the safety and efficacy of intravenous fospropofol (6.5 mg/kg vs. 2 mg/kg) for moderate sedation in patients undergoing colonoscopy. In all, 314 patients >or=18 years (American Society of Anesthesiologists PS1 to PS3) were randomized to receive fospropofol 2 mg/kg, fospropofol 6.5- mg/kg, or midazolam 0.02 mg/kg, after pretreatment with intravenous fentanyl 50 mcg. Supplemental doses of study medication were permitted to achieve a Modified Observer's Assessment of Alertness/Sedation scale score sedation success, recovery, memory retention, physician satisfaction, and safety. Sedation success was higher in the fospropofol 6.5 mg/kg versus 2 mg/kg group (87% vs. 26%; Pmemory retention (70% and 82% for the 6.5 mg/kg and 2 mg/kg groups, respectively) compared with 41% for the midazolam group. Mean physician satisfaction scores were higher in the fospropofol 6.5-mg/kg group (7.7) than the 2-mg/kg group (4.5), Psedation during colonoscopy and was associated with higher rates of sedation success, memory retention, and physician satisfaction than the fospropofol 2-mg/kg dose.

  16. Tribulus terrestris for treatment of sexual dysfunction in women: randomized double-blind placebo - controlled study.

    Science.gov (United States)

    Akhtari, Elham; Raisi, Firoozeh; Keshavarz, Mansoor; Hosseini, Hamed; Sohrabvand, Farnaz; Bioos, Soodabeh; Kamalinejad, Mohammad; Ghobadi, Ali

    2014-04-28

    Tribulus terrestris as a herbal remedy has shown beneficial aphrodisiac effects in a number of animal and human experiments. This study was designed as a randomized double-blind placebo-controlled trial to assess the safety and efficacy of Tribulus terrestris in women with hypoactive sexual desire disorder during their fertile years. Sixty seven women with hypoactive sexual desire disorder were randomly assigned to Tribulus terrestris extract (7.5 mg/day) or placebo for 4 weeks. Desire, arousal, lubrication, orgasm, satisfaction, and pain were measured at baseline and after 4 weeks after the end of the treatment by using the Female Sexual Function Index (FSFI). Two groups were compared by repeated measurement ANOVA test. Thirty women in placebo group and thirty women in drug group completed the study. At the end of the fourth week, patients in the Tribulus terrestris group had experienced significant improvement in their total FSFI (p Tribulus terrestris may safely and effectively improve desire in women with hypoactive sexual desire disorder. Further investigation of Tribulus terrestris in women is warranted.

  17. A nationwide population-based study of low vision and blindness in South Korea.

    Science.gov (United States)

    Park, Shin Hae; Lee, Ji Sung; Heo, Hwan; Suh, Young-Woo; Kim, Seung-Hyun; Lim, Key Hwan; Moon, Nam Ju; Lee, Sung Jin; Park, Song Hee; Baek, Seung-Hee

    2014-12-18

    To investigate the prevalence and associated risk factors of low vision and blindness in the Korean population. This cross-sectional, population-based study examined the ophthalmologic data of 22,135 Koreans aged ≥5 years from the fifth Korea National Health and Nutrition Examination Survey (KNHANES V, 2010-2012). According to the World Health Organization criteria, blindness was defined as visual acuity (VA) less than 20/400 in the better-seeing eye, and low vision as VA of 20/60 or worse but 20/400 or better in the better-seeing eye. The prevalence rates were calculated from either presenting VA (PVA) or best-corrected VA (BCVA). Multivariate regression analysis was conducted for adults aged ≥20 years. The overall prevalence rates of PVA-defined low vision and blindness were 4.98% and 0.26%, respectively, and those of BCVA-defined low vision and blindness were 0.46% and 0.05%, respectively. Prevalence increased rapidly above the age of 70 years. For subjects aged ≥70 years, the population-weighted prevalence rates of low vision, based on PVA and BCVA, were 12.85% and 3.87%, respectively, and the corresponding rates of blindness were 0.49% and 0.42%, respectively. The presenting vision problems were significantly associated with age (younger adults or elderly subjects), female sex, low educational level, and lowest household income, whereas the best-corrected vision problems were associated with age ≥ 70 years, a low educational level, and rural residence. This population-based study provides useful information for planning optimal public eye health care services in South Korea. Copyright 2015 The Association for Research in Vision and Ophthalmology, Inc.

  18. A Placebo-Controlled, Blinded and Randomised Study on the Effects of Recombinant Human Thyrotropin on Quality of Life in the Treatment of Thyroid Cancer

    DEFF Research Database (Denmark)

    Nygaard, Birte; Bastholt, Lars; Bennedbæk, Finn Noe

    2013-01-01

    BACKGROUND: It is well known that thyroid hormone withdrawal (THW) in thyroid cancer patients can induce a decrease in quality of life (QOL). Recombinant human thyrotropin (rh-TSH) has been used to avoid this; however, no blinded studies have ever documented the effect. OBJECTIVE: To compare QOL...... in patients with differentiated thyroid cancer (DTC) treated with either rh-TSH or liothyronine (L-T3) THW for 10 days. STUDY DESIGN: Double-blind, randomised cross-over. PATIENTS: Fifty-six patients with DTC treated by total thyroidectomy and indication for postsurgery radioiodine (RI) ablation therapy...

  19. One year double blind study of high vs low frequency subcallosal cingulate stimulation for depression.

    Science.gov (United States)

    Eitan, Renana; Fontaine, Denys; Benoît, Michel; Giordana, Caroline; Darmon, Nelly; Israel, Zvi; Linesky, Eduard; Arkadir, David; Ben-Naim, Shiri; Iserlles, Moshe; Bergman, Hagai; Hulse, Natasha; Abdelghani, Mohamed; McGuffin, Peter; Farmer, Anne; DeLea, Peichel; Ashkan, Keyoumars; Lerer, Bernard

    2018-01-01

    Subcallosal Brodmann's Area 25 (Cg25) Deep Brain Stimulation (DBS) is a new promising therapy for treatment resistant major depressive disorder (TR-MDD). While different DBS stimulating parameters may have an impact on the efficacy and safety of the therapy, there is no data to support a protocol for optimal stimulation parameters for depression. Here we present a prospective multi-center double-blind randomized crossed-over 13-month study that evaluated the effects of High (130 Hz) vs Low (20 Hz) frequency Cg25 stimulation for nine patients with TR-MDD. Four out of nine patients achieved response criteria (≥40% reduction of symptom score) compared to mean baseline values at the end of the study. The mean percent change of MADRS score showed a similar improvement in the high and low frequency stimulation groups after 6 months of stimulation (-15.4 ± 21.1 and -14.7 ± 21.1 respectively). The mean effect at the end of the second period (6 months after cross-over) was higher than the first period (first 6 months of stimulation) in all patients (-23.4 ± 19.9 (n = 6 periods) and -13.0 ± 22 (n = 9 periods) respectively). At the end of the second period, the mean percent change of the MADRS scores improved more in the high than low frequency groups (-31.3 ± 19.3 (n = 4 patients) and -7.7 ± 10.9 (n = 2 patients) respectively). Given the small numbers, detailed statistical analysis is challenging. Nonetheless the results of this study suggest that long term high frequency stimulation might confer the best results. Larger scale, randomized double blind trials are needed in order to evaluate the most effective stimulation parameters. Copyright © 2017 Elsevier Ltd. All rights reserved.

  20. Venlafaxine versus clonidine for the treatment of hot flashes in breast cancer patients : a double-blind, randomized cross-over study

    NARCIS (Netherlands)

    Buijs, Ciska; Mom, Constantijne H.; Willemse, Pax H. B.; Boezen, H. Marike; Maurer, J. Marina; Wymenga, A. N. Machteld; de Jong, Robert S.; Nieboer, Peter; de Vries, Elisabeth G. E.; Mourits, Marian J. E.

    Purpose Breast cancer patients with treatment-induced menopause experience frequent and severe hot flashes (HF). We compared venlafaxine and clonidine for the treatment of HF with regard to side effects, efficacy, quality of life and sexual functioning. Methods In a double-blind, cross-over study,

  1. A Randomized, Rater-Blinded, Parallel Trial of Intensive Speech Therapy in Sub-Acute Post-Stroke Aphasia: The SP-I-R-IT Study

    Science.gov (United States)

    Martins, Isabel Pavao; Leal, Gabriela; Fonseca, Isabel; Farrajota, Luisa; Aguiar, Marta; Fonseca, Jose; Lauterbach, Martin; Goncalves, Luis; Cary, M. Carmo; Ferreira, Joaquim J.; Ferro, Jose M.

    2013-01-01

    Background: There is conflicting evidence regarding the benefits of intensive speech and language therapy (SLT), particularly because intensity is often confounded with total SLT provided. Aims: A two-centre, randomized, rater-blinded, parallel study was conducted to compare the efficacy of 100 h of SLT in a regular (RT) versus intensive (IT)…

  2. 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].

  3. EFFECT OF TURMERIC (CURCUMA LONGA ON OVERWEIGHT HYPERLIPIDEMIC SUBJECTS: DOUBLE BLIND STUDY

    Directory of Open Access Journals (Sweden)

    Lekhani Pashine

    2012-06-01

    Full Text Available Objective: To evaluate the effect of turmeric (Curcuma longa on serum lipid profile in overweight hyperlipidemic subjects. Methods: This was a double blind randomised control study. The study was conducted in the Department of Medicine, CSM Medical University, Lucknow from July 2010-June 2011. A total of 120 subjects were interviewed using a pre-tested semi-structured schedule whose BMI>25 and total cholesterol>200 mg/dl and/or triglyceride>150 mg/dl, were divided randomly using random number table into 2 groups Group-I (Aquous extract of Turmeric-1.4 gm per day (n=53 and Group-II (Placebo (n=52 for three months. They were given the same color capsules without revealing their identity, with the instructions to take the contents of each pack twice a day before meal for 90 days. Subjects were asked to give their 12 hour fasting blood samples on 0, 30, 60 and 90 day. The paired t-test was used to compare the changes amongst follow-ups and unpaired t-test was used to compare between groups. p-value<0.05 was considered as significant. Results: At the baseline, both the groups were similar in anthropometric and clinical parameters. Treatment group produced significant (p<0.0001 reduction in lipid profiles such as serum total cholesterol, triglyceride and LDL-cholesterol and VLDL- cholesterol in hypercholesteremic group from 0 day to 30, 60 and 90 day of follow-ups. However, there was no significant change in the placebo group. The percentage reduction was higher in the subjects of Turmeric group as compared to Placebo. Conclusion: Aquous extract of Turmeric has shown lipid lowering properties among overweight hyperlipidemic subjects.

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

    DEFF Research Database (Denmark)

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

    2008-01-01

    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...

  5. Immunomodulatory effects of ResistAid™: A randomized, double-blind, placebo-controlled, multidose study.

    Science.gov (United States)

    Udani, Jay K

    2013-01-01

    To evaluate the ability of a proprietary arabinogalactan extract from the larch tree (ResistAid, Lonza Ltd., Basel, Switzerland) to change the immune response in healthy adults to a standardized antigenic challenge (tetanus and influenza vaccines) in a dose-dependent manner compared to placebo. This randomized, double-blind, placebo-controlled trial included 75 healthy adults (18-61 years old). Subjects were randomized to receive either 1.5 or 4.5 g/day of ResistAid or placebo for 60 days. At day 30, subjects were administered both tetanus and influenza vaccines. Serum antigenic response (tetanus immunoglobulin G [IgG], influenza A and B IgG and immunoglobulin M [IgM]) was measured at days 45 (15 days after vaccination) and 60 (30 days after vaccination) of the study and compared to baseline antibody levels. Frequency and intensity of adverse events were monitored throughout the study. As expected, all 3 groups demonstrated an expected rise in tetanus IgG levels 15 and 30 days following the vaccine. There was a strongly significant difference in the rise in IgG levels at day 60 in the 1.5 g/day group compared to placebo (p = 0.008). In the 4.5 g/day group, there was significant rise in tetanus IgG at days 45 and 60 compared to baseline (p < 0.01) but these values were not significant compared to placebo. Neither group demonstrated any significant elevations in IgM or IgG antibodies compared to placebo following the influenza vaccine. There were no clinically or statistically significant or serious adverse events. ResistAid at a dose of 1.5 g/day significantly increased the IgG antibody response to tetanus vaccine compared to placebo. In conjunction with earlier studies, this validates the effect of ResistAid on the augmentation of the response to bacterial antigens (in the form of vaccine).

  6. On-Demand Treatment of Premature Ejaculation with Citalopram: A Randomized Double-Blind Study

    Directory of Open Access Journals (Sweden)

    Ghafuri Zahra

    2009-10-01

    Full Text Available "nAs the most common male sexual disorder premature ejaculation (PE, also referred to as early ejaculation (EE or rapid ejaculation (RE, affects 30%-40% of sexually active men. Despite the limited number of available studies comparing the efficacy of selective serotonin re-uptake inhibitors (SSRI they have been thought to have beneficial effects for the treatment of patients with PE. In the present study, we assessed the efficacy of on-demand use of citalopram, in the treatment of premature ejaculation. A randomized double blind study of fixed dose on-demand use of citalopram was performed in Roozbeh Psychiatry Hospital, Tehran University of Medical Sciences. The sample was consisted of 80 married patients diagnosed with PE according to Diagnostic and Statistical Manual of Mental Disorders. The patients were randomly assigned to two groups: group 1 consisting of 42 patients received 20mg citalopram, and group 2 consisting of 38 patients received placebo four hours before intercourse for a 4-week treatment course. The effects of drug on the ejaculatory function in each group were assessed by the intravaginal ejaculation latency time (IELT, and the Chinese Index of Premature Ejaculation (CIPE before and at the end of treatment course. The mean IELT increased from 66.78±36.94 to 80.85±43.05 seconds in group 1 and from 63.44±33.16 to 65.71±34.26 seconds in group 2 (P = 0.000. Mean CIPE score increased 1.14±1.04 and 0.52±0.50 in group 1 and 2 respectively (P = 0.002. The patients treated with on demand citalopram showed significantly greater improvement in IELT and CIPE score compared to the patients receiving placebo. It seems that citalopram may be an effective treatment of premature ejaculation with on-demand usage. However further studies are warranted.

  7. Restricted neck mobility in children with chronic tension type headache: a blinded, controlled study.

    Science.gov (United States)

    Fernández-Mayoralas, Daniel M; Fernández-de-las-Peñas, César; Palacios-Ceña, Domingo; Cantarero-Villanueva, Irene; Fernández-Lao, Carolina; Pareja, Juan A

    2010-10-01

    The main purpose of this study was to analyze the differences in neck mobility between children with chronic tension type headache (CTTH) and healthy children, and to determine the influence of cervical mobility on headache intensity, frequency and duration. Fifty children, 13 boys and 37 girls (mean age 8.5 ± 1.6 years) with CTTH associated to peri-cranial tenderness (IHS 2.3.1) and 50 age- and sex matched children without headache (13 boys, 37 girls, mean age 8.5 ± 1.8 years, P = 0.955) participated. Cervical range of motion (CROM) was objectively assessed with a cervical goniometer by an assessor blinded to the children's condition. Children completed a headache diary for 4 weeks to confirm the diagnosis. Children with CTTH showed decreased CROM as compared to children without headache for flexion (z = -6.170; P 0.125) or gender (P > 0.250) did not influence CROM in either children with CTTH or without headache. Current results support the hypothesis that the cervical spine should be explored in children with headache. Further research is also needed to clearly define the potential role of the cervical spine in the genesis or maintenance of CTTH.

  8. Heartburn treatment in primary care: randomised, double blind study for 8 weeks

    Science.gov (United States)

    Hatlebakk, Jan G; Hyggen, Arild; Madsen, Per H; Walle, Per O; Schulz, Tom; Mowinckel, Petter; Bernklev, Tomm; Berstad, Arnold

    1999-01-01

    Objective To compare the effects and tolerability of omeprazole and cisapride with that of placebo for control of heartburn in primary care patients. Design Randomised, double blind, placebo controlled study. Setting 65 primary care practices in Norway. Participants 483 untreated patients with complaints of heartburn ⩾3 days a week, with at most grade 1 reflux oesophagitis. Interventions Omeprazole 20 mg once daily, cisapride 20 mg twice daily, or placebo for 8 weeks. Main outcome measures Adequate control of heartburn, defined as ⩽1 day of the past 7 days with no more than mild heartburn, after 4 weeks of treatment. Results In the all patients treated analysis, adequate control of heartburn was achieved in 71% of patients taking omeprazole, 22% taking cisapride, and 18% taking placebo after 4 weeks of treatment (omeprazole v cisapride and placebo, Pheartburn whereas cisapride 20 mg twice daily was not significantly more effective than placebo. Key messagesIn primary care patients, heartburn is commonly treated empiricallyMost randomised clinical trials of treatment for heartburn have been conducted in specialist care, and documentation for empirical treatment is limitedOmeprazole was significantly more effective than cisapride or placebo in controlling heartburn and other symptoms of gastro-oesophageal reflux after 2, 4, and 8 weeks, whereas cisapride did not differ significantly from placeboOmeprazole should be considered as a first choice for empirical treatment of heartburn in primary care PMID:10463897

  9. Topical tocopherol for treatment of reticular oral lichen planus: a randomized, double-blind, crossover study.

    Science.gov (United States)

    Bacci, C; Vanzo, V; Frigo, A C; Stellini, E; Sbricoli, L; Valente, M

    2017-01-01

    This randomized, double-blind, placebo-controlled crossover study assessed the efficacy of topical tocopherol acetate compared with placebo in easing oral discomfort in patients with reticular oral lichen planus (ROLP). Thirty-four patients with clinically diagnosed and histologically confirmed ROLP were randomly assigned to two groups, which received first one of two treatments (treatment 1 or 2) for a month, then the other (treatment 2 or 1) for another month, with a two-week washout between them. One treatment contained tocopherol acetate and the other only liquid paraffin. The primary outcome was less discomfort, measured on a visual analog scale (VAS). Secondary outcomes were as follows: length of striae measured and photographed at each follow-up; surface area of lesions; and a modified Thongprasom score. No statistically significant differences emerged between the two treatments (1 vs 2) in terms of VAS scores (P > 0.05; 0.8624) or length of striae (P = 0.0883). Significant differences were seen for surface area of lesions (P < 0.05, P = 0.0045) and modified Thongprasom scores (P = 0.0052). The two treatments differed only in terms of the surface area of the lesions and Thongprasom scores, not in VAS scores for discomfort or the length of patients' striae. Topical tocopherol proved effective in the treatment of ROLP. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  10. Clinical Efficacy and Safety of Benjakul Remedy Extract for Treating Primary Osteoarthritis of Knee Compared with Diclofenac: Double Blind, Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Patamaporn Rachawat

    2017-01-01

    Full Text Available Background. The purpose of this study was to investigate the clinical efficacy and safety of Benjakul (BJK extract for treating primary osteoarthritis (OA of the knee compared with diclofenac. Methods. A phase 2, double blind, randomized, and controlled study was conducted. The BJK group received 300 mg of BJK extract per day, while another group received 75 mg of diclofenac per day. All patients were followed up at 14 and 28 days. The changing of visual analogue scale (VAS for pain, 100-meter walking times, the modified Thai WOMAC index scores, and the global assessment were evaluated for efficacy. For safety issue, clinical signs and symptoms, complete physical examination, and renal and liver function were evaluated. Results. 39 and 38 patients for BJK extract group and diclofenac group were evaluated. For efficacy, all patients from both groups reported a decrease in the VAS pain score and 100-meter walking times but only the diclofenac group showed significant reduction of both measurements when compared with day 0. The modified Thai WOMAC scores of both groups were significantly reduced from baseline. However, all efficacy outcomes were not significantly different for both groups. For safety outcomes, the patients from both groups had no severe adverse events reported and only BJK had no toxicity in renal and liver functions. Conclusions. The BJK remedy extract showed equal clinical efficacy in relieving symptoms of OA knee when compared with diclofenac.

  11. Dense cranial electroacupuncture stimulation for major depressive disorder--a single-blind, randomized, controlled study.

    Directory of Open Access Journals (Sweden)

    Zhang-Jin Zhang

    Full Text Available BACKGROUND: Previous studies suggest that electroacupuncture possesses therapeutic benefits for depressive disorders. The purpose of this study was to determine whether dense cranial electroacupuncture stimulation (DCEAS could enhance the antidepressant efficacy in the early phase of selective serotonin reuptake inhibitor (SSRI treatment of major depressive disorder (MDD. METHODS: In this single-blind, randomized, controlled study, patients with MDD were randomly assigned to 9-session DCEAS or noninvasive electroacupuncture (n-EA control procedure in combination with fluoxetine (FLX for 3 weeks. Clinical outcomes were measured using the 17-item Hamilton Depression Rating Scale (HAMD-17, Clinical Global Impression-severity (CGI-S, and Self-rating Depression Scale (SDS as well as the response and remission rates. RESULTS: Seventy-three patients were randomly assigned to n-EA (n = 35 and DCEAS (n = 38, of whom 34 in n-EA and 36 in DCEAS group were analyzed. DCEAS-treated patients displayed a significantly greater reduction from baseline in HAMD-17 scores at Day 3 through Day 21 and in SDS scores at Day 3 and Day 21 compared to patients receiving n-EA. DCEAS intervention also produced a higher rate of clinically significant response compared to n-EA procedure (19.4% (7/36 vs. 8.8% (3/34. The incidence of adverse events was similar in the two groups. CONCLUSIONS: DCEAS is a safe and effective intervention that augments the antidepressant efficacy. It can be considered as an additional therapy in the early phase of SSRI treatment of depressed patients. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN88008690.

  12. Metabolic changes in the visual cortex of binocular blindness macaque monkeys: a proton magnetic resonance spectroscopy study.

    Directory of Open Access Journals (Sweden)

    Lingjie Wu

    Full Text Available PURPOSE: To evaluate proton magnetic resonance spectroscopy ((1H-MRS in a study of cross-modal plasticity in the visual cortex of binocular blindness macaque monkeys. MATERIALS AND METHODS: Four healthy neonatal macaque monkeys were randomly divided into 2 groups, with 2 in each group. Optic nerve transection was performed in both monkeys in the experimental group (group B to obtain binocular blindness. Two healthy macaque monkeys served as a control group (group A. After sixteen months post-procedure, (1H-MRS was performed in the visual cortex of all monkeys. We compared the peak areas of NAA, Cr, Cho, Glx and Ins and the ratios of NAA/Cr, Cho/Cr, Glx/Cr and Ins/Cr of each monkey in group B with group A. RESULTS: The peak area of NAA and the NAA/Cr ratio in the visual cortex of monkey 4 in group B were found to be dramatically decreased, the peak area of NAA slightly decreased and the NAA/Cr ratio clearly decreased in visual cortex of monkey 3 in group B than those in group A. The peak area of Ins and the Ins/Cr ratio in the visual cortex of monkey 4 in group B slightly increased. The peak area of Cho and the Cho/Cr ratio in the visual cortex of all monkeys in group B dramatically increased compared with group A. The peak area of Glx in the visual cortex of all monkeys in group B slightly increased compared with group A. CONCLUSIONS: (1H-MRS could detect biochemical and metabolic changes in the visual cortex and therefore this technique can be used to provide valuable information for investigating the mechanisms of cross-modal plasticity of binocular blindness in a macaque monkey model.

  13. Lumbar Intradiskal Platelet-Rich Plasma (PRP) Injections: A Prospective, Double-Blind, Randomized Controlled Study.

    Science.gov (United States)

    Tuakli-Wosornu, Yetsa A; Terry, Alon; Boachie-Adjei, Kwadwo; Harrison, Julian R; Gribbin, Caitlin K; LaSalle, Elizabeth E; Nguyen, Joseph T; Solomon, Jennifer L; Lutz, Gregory E

    2016-01-01

    To determine whether single injections of autologous platelet-rich plasma (PRP) into symptomatic degenerative intervertebral disks will improve participant-reported pain and function. Prospective, double-blind, randomized controlled study. Outpatient physiatric spine practice. Adults with chronic (≥6 months), moderate-to-severe lumbar diskogenic pain that was unresponsive to conservative treatment. Participants were randomized to receive intradiskal PRP or contrast agent after provocative diskography. Data on pain, physical function, and participant satisfaction were collected at 1 week, 4 weeks, 8 weeks, 6 months, and 1 year. Participants in the control group who did not improve at 8 weeks were offered the option to receive PRP and subsequently followed. Functional Rating Index (FRI), Numeric Rating Scale (NRS) for pain, the pain and physical function domains of the 36-item Short Form Health Survey, and the modified North American Spine Society (NASS) Outcome Questionnaire were used. Forty-seven participants (29 in the treatment group, 18 in the control group) were analyzed by an independent observer with a 92% follow-up rate. Over 8 weeks of follow-up, there were statistically significant improvements in participants who received intradiskal PRP with regards to pain (NRS Best Pain) (P = .02), function (FRI) (P = .03), and patient satisfaction (NASS Outcome Questionnaire) (P = .01) compared with controls. No adverse events of disk space infection, neurologic injury, or progressive herniation were reported following the injection of PRP. Participants who received intradiskal PRP showed significant improvements in FRI, NRS Best Pain, and NASS patient satisfaction scores over 8 weeks compared with controls. Those who received PRP maintained significant improvements in FRI scores through at least 1 year of follow-up. Although these results are promising, further studies are needed to define the subset of participants most likely to respond to biologic intradiskal

  14. Effectiveness of PELOID therapy in carpal tunnel syndrome: A randomized controlled single blind study

    Science.gov (United States)

    Metin Ökmen, Burcu; Kasapoğlu Aksoy, Meliha; Güneş, Aygül; Eröksüz, Riza; Altan, Lale

    2017-08-01

    Carpal tunnel syndrome(CTS) is the most common neuromuscular cause of upper extremity disability. We aimed to investigate the effectiveness of peloid therapy in patients with CTS. This randomized, controlled, single-blind study enrolled 70 patients between the ages of 30 to 65 who had a diagnosis of either mild, mild-to-moderate, or moderate CTS. The patients were randomized into two groups using random number table. In the first group, (Group 1)( n = 35), patients were given splint (every night for 6 weeks) + peloid treatment(five consecutive days a week for 2 weeks) and in the second group, (Group 2)( n = 28), patients received splint treatment(every night for 6 weeks) alone. The patients were assessed by using visual analog scale(VAS) for pain, electroneuromyography(ENMG), the Boston Carpal Tunnel Syndrome Questionnaire(BCTSQ), hand grip strength(HGS), finger grip strength(FGS), and Short Form-12(SF-12). The data were obtained before treatment(W0), immediately after treatment(W2), and one month after treatment(W6). Both in Group 1 and 2, there was a statistically significant improvement in all the evaluation parameters at W2 and W6 when compared to W0( p < 0.05). Comparison of the groups with each other revealed significantly better results for VAS, BCTSQ, mSNCV, SF-12 in Group 1 than in Group 2 at W2( p < 0.05). There was also a statistically significant difference in favor of Group 1 for VAS, BCTSQ, FGS and MCS at W6 when compared to W0 ( p < 0.05). The results of our study demonstrated that in patients with CTS; peloid + splint treatment was more effective than splint treatment alone in pain, functionality and life quality both at after treatment(W2) and one month after treatment (W6). We may suggest peloid as a supplementary therapeutic agent in CTS.

  15. Comparative study Beamnrc VS Pinnacle

    International Nuclear Information System (INIS)

    Moreno Reyes, J. C.; Macias Jaen, J.; Jimenez Ortega, E.

    2013-01-01

    Has been developed in JAVA a software application called JJGAMMA, capable of manipulating the environment BEAMNRC and Pinnacle output formats 3 , comfortable, fast and accurately. As particular application you can use to compare dose distributions (plans for treatments, checking fields for modeling and clinical accelerators Commissioner) using, as objective criteria, function or Gamma index. (Author)

  16. Paracetamol suppositories: a comparative study.

    Science.gov (United States)

    Cullen, S; Kenny, D; Ward, O C; Sabra, K

    1989-01-01

    Paracetamol suppositories in two different bases were given to children who had fever after operations. Plasma concentrations and the effect on temperature were compared. There was a significant correlation between peak plasma concentrations and maximum drop in temperature. A lipophilic base produced better results than a hydrophilic base. PMID:2817936

  17. Paracetamol suppositories: a comparative study.

    OpenAIRE

    Cullen, S; Kenny, D; Ward, O C; Sabra, K

    1989-01-01

    Paracetamol suppositories in two different bases were given to children who had fever after operations. Plasma concentrations and the effect on temperature were compared. There was a significant correlation between peak plasma concentrations and maximum drop in temperature. A lipophilic base produced better results than a hydrophilic base.

  18. Tactile spatial resolution in blind braille readers.

    Science.gov (United States)

    Van Boven, R W; Hamilton, R H; Kauffman, T; Keenan, J P; Pascual-Leone, A

    2000-06-27

    To determine if blind people have heightened tactile spatial acuity. Recently, studies using magnetic source imaging and somatosensory evoked potentials have shown that the cortical representation of the reading fingers of blind Braille readers is expanded compared to that of fingers of sighted subjects. Furthermore, the visual cortex is activated during certain tactile tasks in blind subjects but not sighted subjects. The authors hypothesized that the expanded cortical representation of fingers used in Braille reading may reflect an enhanced fidelity in the neural transmission of spatial details of a stimulus. If so, the quantitative limit of spatial acuity would be superior in blind people. The authors employed a grating orientation discrimination task in which threshold performance is accounted for by the spatial resolution limits of the neural image evoked by a stimulus. The authors quantified the psychophysical limits of spatial acuity at the middle and index fingers of 15 blind Braille readers and 15 sighted control subjects. The mean grating orientation threshold was significantly (p = 0.03) lower in the blind group (1.04 mm) compared to the sighted group (1.46 mm). The self-reported dominant reading finger in blind subjects had a mean grating orientation threshold of 0.80 mm, which was significantly better than other fingers tested. Thresholds at non-Braille reading fingers in blind subjects averaged 1.12 mm, which were also superior to sighted subjects' performances. Superior tactile spatial acuity in blind Braille readers may represent an adaptive, behavioral correlate of cortical plasticity.

  19. The Acuity of Echolocation: Spatial Resolution in Sighted Persons Compared to the Performance of an Expert Who Is Blind

    Science.gov (United States)

    Teng, Santani; Whitney, David

    2011-01-01

    Echolocation is a specialized application of spatial hearing that uses reflected auditory information to localize objects and represent the external environment. Although it has been documented extensively in nonhuman species, such as bats and dolphins, its use by some persons who are blind as a navigation and object-identification aid has…

  20. Mucuna pruriens in Parkinson's disease: a double blind clinical and pharmacological study

    Science.gov (United States)

    Katzenschlager, R; Evans, A; Manson, A; Patsalos, P; Ratnaraj, N; Watt, H; Timmermann, L; Van der Giessen, R; Lees, A

    2004-01-01

    Background: The seed powder of the leguminous plant, Mucuna pruriens has long been used in traditional Ayurvedic Indian medicine for diseases including parkinsonism. We have assessed the clinical effects and levodopa (L-dopa) pharmacokinetics following two different doses of mucuna preparation and compared them with standard L-dopa/carbidopa (LD/CD). Methods: Eight Parkinson's disease patients with a short duration L-dopa response and on period dyskinesias completed a randomised, controlled, double blind crossover trial. Patients were challenged with single doses of 200/50 mg LD/CD, and 15 and 30 g of mucuna preparation in randomised order at weekly intervals. L-Dopa pharmacokinetics were determined, and Unified Parkinson's Disease Rating Scale and tapping speed were obtained at baseline and repeatedly during the 4 h following drug ingestion. Dyskinesias were assessed using modified AIMS and Goetz scales. Results: Compared with standard LD/CD, the 30 g mucuna preparation led to a considerably faster onset of effect (34.6 v 68.5 min; p = 0.021), reflected in shorter latencies to peak L-dopa plasma concentrations. Mean on time was 21.9% (37 min) longer with 30 g mucuna than with LD/CD (p = 0.021); peak L-dopa plasma concentrations were 110% higher and the area under the plasma concentration v time curve (area under curve) was 165.3% larger (p = 0.012). No significant differences in dyskinesias or tolerability occurred. Conclusions: The rapid onset of action and longer on time without concomitant increase in dyskinesias on mucuna seed powder formulation suggest that this natural source of L-dopa might possess advantages over conventional L-dopa preparations in the long term management of PD. Assessment of long term efficacy and tolerability in a randomised, controlled study is warranted. PMID:15548480

  1. Blindness and visual impairment in retinitis pigmentosa: a Cameroonian hospital-based study

    Directory of Open Access Journals (Sweden)

    André Omgbwa Eballe

    2010-06-01

    Full Text Available André Omgbwa Eballe1, Godefroy Koki2, Claude Bernard Emche2, Lucienne Assumpta Bella2, Jeanne Mayouego Kouam2, Justin Melong31Faculty of Medicine and Pharmaceutical Sciences, University of Douala; 2Faculty of Medicine and Biomedical Sciences, University of Yaoundé; 3Translation Unit, Ministry of Public Health, Yaoundé, CameroonAim: We performed a retrospective, analytical study in February 2010 on all retinitis pigmentosa cases seen during ophthalmologic consultation at the Gyneco-Obstetrics and Pediatric Hospital of Yaounde between March 2002 and December 2009 (82 months. The aim of this research was to determine the significance of blindness and visual impairment associated with retinitis pigmentosa in Cameroon.Results: Forty cases were reported, corresponding to a hospital prevalence of 1.6/1000 (21 men and 19 women. The average age of the patients was 43.3 ± 18 years, ranging between 6 and 74 years. Bilateral blindness and low vision was noted in 30% and 27.5% of patients, respectively. The average age of patients with low vision was 40.38 ± 16.27 years and the average age of those with bilateral blindness was 51.08 ± 15.79 years. Retinitis pigmentosa was bilateral in all cases and isolated (without any eye or general additional disease in 67.5% of cases.Conclusion: Visual impairment is common and becomes even more severe with aging. Patients should be screened to enable them to benefit from management focusing on both appropriate treatment and genetic counseling.Keywords: retinitis pigmentosa, Cameroon, blindness, Yaoundé

  2. A double-blind, randomized controlled trial to compare the effect of biannual peripheral magnetic resonance imaging, radiography and standard of care disease progression monitoring on pharmacotherapeutic escalation in rheumatoid and undifferentiated inflammatory arthritis: study protocol for a randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background Permanent joint damage is a major consequence of rheumatoid arthritis (RA), the most common and destructive form of inflammatory arthritis. In aggressive disease, joint damage can occur within 6 months from symptom onset. Early, intensive treatment with conventional and biologic disease-modifying anti-rheumatic drugs (DMARDs) can delay the onset and progression of joint damage. The primary objective of the study is to investigate the value of magnetic resonance imaging (MRI) or radiography (X-ray) over standard of care as tools to guide DMARD treatment decision-making by rheumatologists for the care of RA. Methods A double-blind, randomized controlled trial has been designed. Rheumatoid and undifferentiated inflammatory arthritis patients will undergo an MRI and X-ray assessment every 6 months. Baseline adaptive randomization will be used to allocate participants to MRI, X-ray, or sham-intervention groups on a background of standard of care. Prognostic markers, treating physician, and baseline DMARD therapy will be used as intervention allocation parameters. The outcome measures in rheumatology RA MRI score and the van der Heijde-modified Sharp score will be used to evaluate the MRI and X-ray images, respectively. Radiologists will score anonymized images for all patients regardless of intervention allocation. Disease progression will be determined based on the study-specific, inter-rater smallest detectable difference. Allocation-dependent, intervention-concealed reports of positive or negative disease progression will be reported to the treating rheumatologist. Negative reports will be delivered for the sham-intervention group. Study-based radiology clinical reports will be provided to the treating rheumatologists for extra-study X-ray requisitions to limit patient radiation exposure as part of diagnostic imaging standard of care. DMARD treatment dose escalation and therapy changes will be measured to evaluate the primary objective. A sample size of

  3. Treatment of hypothyroidism with levothyroxine plus liothyronine: a randomized, double-blind, crossover study.

    Science.gov (United States)

    Kaminski, Juliana; Miasaki, Fabíola Yukiko; Paz-Filho, Gilberto; Graf, Hans; Carvalho, Gisah Amaral de

    2016-01-01

    To compare the effects of a unique fixed combination levothyroxine/liothyronine (LT4/LT3) therapy in patients with primary hypothyroidism. This is a randomized, double-blind, crossover study. Adults with primary hypothyroidism (n = 32, age 42.6 ± 13.3, 30 females) on stable doses of LT4 for ≥ 6 months (125 or 150 μg/day) were randomized to continue LT4 treatment (G1) or to start LT4/LT3 therapy (75/15 μg/day; G2). After 8 weeks, participants switched treatments for 8 more weeks. Thyroid function, lipid profile, plasma glucose, body weight, electrocardiogram, vital signs, and quality of life (QoL) were evaluated at weeks 0, 8 and 16. Free T4 levels were significantly lower while on LT4/LT3 (G1: 1.07 ± 0.29 vs. 1.65 ± 0.46; G2: 0.97 ± 0.26 vs. 1.63 ± 0.43 ng/dL; P < 0.001). TSH and T3 levels were not affected by type of therapy. More patients on LT4/LT3 had T3 levels above the upper limit (15% vs. 3%). The combination therapy led to an increase in heart rate, with no significant changes in electrocardiogram or arterial blood pressure. Lipid profile, body weight and QoL remained unchanged. The combination therapy yielded significantly lower free T4 levels, with no changes in TSH or T3 levels. More patients on LT4/T3 had elevated T3 levels, with no significant alterations in the evaluated outcomes. No clear clinical benefit of the studied formulation could be observed. Future trials need to evaluate different formulations and the impact of the combined therapy in select populations with genetic polymorphisms.

  4. Effects of Febuxostat in Early Gout: A Randomized, Double-Blind, Placebo-Controlled Study.

    Science.gov (United States)

    Dalbeth, Nicola; Saag, Kenneth G; Palmer, William E; Choi, Hyon K; Hunt, Barbara; MacDonald, Patricia A; Thienel, Ulrich; Gunawardhana, Lhanoo

    2017-12-01

    To assess the effect of treatment with febuxostat versus placebo on joint damage in hyperuricemic subjects with early gout (1 or 2 gout flares). In this double-blind, placebo-controlled study, 314 subjects with hyperuricemia (serum uric acid [UA] level of ≥7.0 mg/dl) and early gout were randomized 1:1 to receive once-daily febuxostat 40 mg (increased to 80 mg if the serum UA level was ≥6.0 mg/dl on day 14) or placebo. The primary efficacy end point was the mean change from baseline to month 24 in the modified Sharp/van der Heijde erosion score for the single affected joint. Additional efficacy end points included change from baseline to month 24 in the Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) scores for synovitis, erosion, and edema in the single affected joint, the incidence of gout flares, and serum UA levels. Safety was assessed throughout the study. Treatment with febuxostat did not lead to any notable changes in joint erosion over 2 years. In both treatment groups, the mean change from baseline to month 24 in the modified Sharp/van der Heijde erosion score for the single affected joint was minimal, with no between-group differences. However, treatment with febuxostat significantly improved the RAMRIS synovitis score at month 24 compared with placebo treatment (change from baseline -0.43 versus -0.07; P gout flares (29.3% versus 41.4%; P gout flares in subjects with early gout. © 2017 The Authors. Arthritis & Rheumatology published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.

  5. Remifentanil in combination with ketamine versus remifentanil in spinal fusion surgery--a double blind study.

    Science.gov (United States)

    Hadi, B A; Al Ramadani, R; Daas, R; Naylor, I; Zelkó, R

    2010-08-01

    This study is aimed at conducting a program for two different anesthetic methods used during a spinal fusion surgery to ensure better intra-operative hemodynamic stability and post-operative pain control. A prospective, randomized, double blind study in patients scheduled for spinal fusion surgery, who were randomly allocated to two groups, G1 and G2, (n = 15 per group), class I-II ASA, was carried out. Both groups received pre-operatively midazolam, followed intra-operatively by propofol, sevoflurane, atracurium, and either remifentanil infusion 0.2 microg/kg/min (G1), or the same dose of remifentanil infusion and low doses of ketamine infusion 1 microg/kg/min (G2) anesthetics, antidote medication and post-operative morphine doses. HR, MAP, vital signs, surgical bleeding, urine output, duration of surgery and duration of anesthesia were recorded. In a 24-h recovery period in a post-anesthesia care unit (PACU) the recovery time, the first pain score and analgesic requirements were measured. Intra-operative HR and arterial BP were significantly less (p < 0.05) in G1 as compared to G2. In the PACU the first pain scores were significantly less (p < 0.05) in G2 than in G1. The time for the first patient analgesia demand dose was greater in G2, as also morphine consumption which was greater in G1 than G2 (p < 0.05). Other results were the same. None of the patients had any adverse drug reaction. Adding low doses of ketamine hydrochloride could be a routine therapy to improve the hemodynamic stability and reduce the post-operative morphine consumption during spinal fusion surgery.

  6. Benchmarked Library Websites Comparative Study

    KAUST Repository

    Ramli, Rindra M.; Tyhurst, Janis

    2015-01-01

    This presentation provides an analysis of services provided by the benchmarked library websites. The exploratory study includes comparison of these websites against a list of criterion and presents a list of services that are most commonly deployed by the selected websites. In addition to that, the investigators proposed a list of services that could be provided via the KAUST library website.

  7. A comparative study of flurbiprofen and piroxicam in osteoarthritis.

    Directory of Open Access Journals (Sweden)

    Misra N

    1992-10-01

    Full Text Available In this single-blind, multiple-dose study the efficacy and tolerability of flurbiprofen was compared with that of piroxicam in 60 adult patients suffering from osteoarthritis of the knee. The patients were randomly allocated to receive either flurbiprofen 100 mg twice daily or piroxicam 20 mg once daily for a period of four weeks. Clinical assessments w.r.t. pain, tenderness, stiffness, swelling and general activity of patient were carried out prior to initiation of trial therapy and thereafter at weekly intervals for four weeks. The findings were graded. Though significant improvements as compared to baseline data occurred in both the treatment groups, flurbiprofen was found to be superior to piroxicam in improving pain on movement and at rest (p < 0.05. The incidence of side effects was less in the group receiving flurbiprofen (6% compared to 47% observed with piroxicam.

  8. COMPARATIVE STUDY ON CORPORATE GOVERNANCE

    Directory of Open Access Journals (Sweden)

    Gavrea Corina

    2011-12-01

    Full Text Available Corporate governance is a key element of today’s economic reality being more and more present in many countries around the world. This paper has two main objectives. The first one is to offer more insight into the concept of corporate governance by a thorough literature review and by presenting and analyzing a framework of corporate governance. The second objective of this paper is to investigate the corporate governance situation in three developing economies (Romania, Bulgaria and Hungary. The World Bank and the European Bank for Reconstruction and Development published a series of reports on corporate governance. The present study uses data from these reports in order to illustrate how these developing economies are dealing with corporate governance. Based on ROSC Reports a corporate governance score was calculated. As this score shows, there is room for improvement for all three developing economies. This study is important because it shows the differences in corporate governance among developing economies and the need to study these nations at the individual country level. Corporate governance has many benefits for developing economies. It helps developing economies to register sustainable growth rates, to increases investors’ confidence in the national economy, and to increase the ability of capital markets to mobilize savings.

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

    Directory of Open Access Journals (Sweden)

    Jeffrey Campsen

    2017-06-01

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

  10. Tactile perception in blind Braille readers: a psychophysical study of acuity and hyperacuity using gratings and dot patterns.

    Science.gov (United States)

    Grant, A C; Thiagarajah, M C; Sathian, K

    2000-02-01

    It is not clear whether the blind are generally superior to the sighted on measures of tactile sensitivity or whether they excel only on certain tests owing to the specifics of their tactile experience. We compared the discrimination performance of blind Braille readers and age-matched sighted subjects on three tactile tasks using precisely specified stimuli. Initially, the blind significantly outperformed the sighted at a hyperacuity task using Braille-like dot patterns, although, with practice, both groups performed equally well. On two other tasks, hyperacute discrimination of gratings that differed in ridge width and spatial-acuity-dependent discrimination of grating orientation, the performance of the blind did not differ significantly from that of sighted subjects. These results probably reflect the specificity of perceptual learning due to Braille-reading experience.

  11. Efficacy of kinesio taping on isokinetic quadriceps torque in knee osteoarthritis: a double blinded randomized controlled study.

    Science.gov (United States)

    Anandkumar, Sudarshan; Sudarshan, Shobhalakshmi; Nagpal, Pratima

    2014-08-01

    Double blind pre-test post-test control group design. To compare the isokinetic quadriceps torque, standardized stair-climbing task (SSCT) and pain during SSCT between subjects diagnosed with knee osteoarthritis pre and post kinesio tape (KT) application with and without tension. Strength of the quadriceps and torque producing capability is frequently found to be compromised in knee osteoarthritis. The efficacy of KT in improving isokinetic quadriceps torque in knee osteoarthritis is unknown, forming the basis for this study. Forty subjects were randomly allocated to either the experimental (therapeutic KT with tension) or control group (sham KT without tension) with the allocation being concealed. Pre and post test measurements of isokinetic quadriceps torque, SSCT and pain during SSCT were carried out by a blinded assessor. A large effect size with significant improvements in the peak quadriceps torque (concentric and eccentric at angular velocities of 90° per second and 120° per second), SSCT and pain were obtained in the experimental group when compared to the control group. Application of therapeutic KT is effective in improving isokinetic quadriceps torque, SSCT and reducing pain in knee osteoarthritis.

  12. Maternal kisses are not effective in alleviating minor childhood injuries (boo-boos): a randomized, controlled and blinded study.

    Science.gov (United States)

    2015-12-01

    The practice of maternal kissing of minor injuries of childhood (boo-boos), though widely endorsed and practised, has never been demonstrated to be of benefit to children. To determine the efficacy, if any, of maternal kissing of boo-boos in toddlers. Randomized, controlled and double-blinded study of children with experimentally induced minor injuries. Control arms included both no intervention group and 'sham' (non-maternal) kissing. Children were blinded to the identity of the kisser in both the maternal and sham control groups. Outpatient research clinics in Ottawa, Canada. 943 maternal-toddler pairs recruited from the community. Toddler Discomfort Index (TDI) pre-injury, 1 and 5 minutes post-injury. One-minute and 5-minute TDI scores did not differ significantly between the maternal and sham kiss groups. Both of these groups had significantly higher TDI scores at 5 minutes compared to the no intervention group. Maternal kissing of boo-boos confers no benefit on children with minor traumatic injuries compared to both no intervention and sham kissing. In fact, children in the maternal kissing group were significantly more distressed at 5 minutes than were children in the no intervention group. The practice of maternal kissing of boo-boos is not supported by the evidence and we recommend a moratorium on the practice. © 2015 John Wiley & Sons, Ltd.

  13. Prevention of upper gastrointestinal bleeding in critically ill Chinese patients: a randomized, double-blind study evaluating esomeprazole and cimetidine.

    Science.gov (United States)

    Lou, Wenhui; Xia, Ying; Xiang, Peng; Zhang, Liangqing; Yu, Xiangyou; Lim, Sam; Xu, Mo; Zhao, Lina; Rydholm, Hans; Traxler, Barry; Qin, Xinyu

    2018-04-20

    To assess the efficacy and safety of esomeprazole in preventing upper gastrointestinal (GI) bleeding in critically ill Chinese patients, using cimetidine as an active comparator. A pre-specified non-inferiority limit (5%) was used to compare rates of significant upper GI bleeding in this randomized, double-blind, parallel-group, phase 3 study across 27 intensive care units in China. Secondary endpoints included safety and tolerability measures. Patients required mechanical ventilation and had at least one additional risk factor for stress ulcer bleeding. Patients were randomized to receive either active esomeprazole 40 mg, as a 30-min intravenous (IV) infusion twice daily, and an IV placebo cimetidine infusion or active cimetidine 50 mg/h, as a continuous infusion following an initial bolus of 300 mg, and placebo esomeprazole injections, given up to 14 days. Patients were blinded using this double-dummy technique. Of 274 patients, 2.7% with esomeprazole and 4.6% with cimetidine had significant upper GI bleeding (bright red blood in the gastric tube not clearing after lavage or persistent Gastroccult-positive "coffee grounds" material). Non-inferiority of esomeprazole to cimetidine was demonstrated. The safety profiles of both drugs were similar and as expected in critically ill patients. Esomeprazole is effective in preventing upper GI bleeding in critically ill Chinese patients, as demonstrated by the non-inferiority analysis using cimetidine as an active control. ClinicalTrials.gov identifier NCT02157376.

  14. Effects of kinesiotaping on foot posture in participants with pronated foot: a quasi-randomised, double-blind study.

    Science.gov (United States)

    Luque-Suarez, Alejandro; Gijon-Nogueron, Gabriel; Baron-Lopez, Francisco Javier; Labajos-Manzanares, Maria Teresa; Hush, Julia; Hancock, Mark Jonathan

    2014-03-01

    To investigate whether kinesiotaping improves excessive foot pronation compared with sham kinesiotaping. Quasi-randomised, double-blind study. One primary care centre. One hundred and thirty participants were screened for inclusion. Sixty-eight participants with pronated feet [Foot Posture Index (FPI)≥ 6] were enrolled, and the follow-up rate was 100%. Participants were allocated into one of two groups: an experimental kinesiotaping group (KT1) and a sham taping group (KT2). Measures were collected by a blinded assessor at baseline, and 1 minute, 10 minutes, 60 minutes and 24 hours after taping. The primary outcome was total FPI score, and the secondary outcome was rear-foot FPI score. There were no significant differences in total FPI score between kinesiotaping and sham taping at any time point. Similarly, there were no significant differences in rear-foot FPI score, apart from at 60-minute follow-up when the difference between groups was significant (P=0.04) but the effect size was very small (0.85 points on the rear-foot FPI score between -6 and +6). Kinesiotaping does not correct foot pronation compared with sham kinesiotaping in people with pronated feet. Copyright © 2013 Chartered Society of Physiotherapy. All rights reserved.

  15. Prospective, double blind, randomized, controlled trial comparing vapocoolant spray versus placebo spray in adults undergoing intravenous cannulation.

    Science.gov (United States)

    Mace, Sharon E

    2017-10-01

    Painful diagnostic and therapeutic procedures are common in the health care setting. Eliminating, or at least, minimizing the pain associated with various procedures should be a priority. Although there are many benefits of providing local/topical anesthesia prior to performing painful procedures, ranging from greater patient/family satisfaction to increased procedural success rates; local/topical anesthetics are frequently not used. Reasons include the need for a needlestick to administer local anesthetics such as lidocaine and the long onset for topical anesthetics. Vapocoolants eliminate the risks associated with needlesticks, avoids the tissue distortion with intradermal local anesthetics, eliminates needlestick pain, have a quick almost instantaneous onset, are easy to apply, require no skills or devices to apply, are convenient, and inexpensive. The aims of this study were to ascertain if peripheral intravenous (PIV) cannulation pain would be significantly decreased by using a vapocoolant (V) versus sterile water placebo (S) spray, as determined by a reduction of at least ≥1.8 points on numerical rating scale (NRS) after vapocoolant versus placebo spray, the side effects and incidence of side effects from a vapocoolant spray; and whether there were any long term visible skin abnormalities associated with the use of a vapocoolant spray. Prospective, randomized, double-blind controlled trial of 300 adults (ages 18-80) requiring PIV placement in a hospital ED, randomized to S (N=150) or V (N=150) prior to PIV. Efficacy outcome was the difference in PIV pain: NRS from 0 (none) to worst (10). Safety outcomes included a skin checklist for local adverse effects (i.e., redness, blanching, edema, ecchymosis, itching, changes in skin pigmentation), vital sign (VS) changes, and before/after photographs of the PIV site. Patient demographics (age, gender, race), comorbidity, medications, and vital signs; and PIV procedure variables (e.g., IV needle size, location

  16. Comparative study of Butterfly valves

    International Nuclear Information System (INIS)

    Galmes Belmonte, F.B.

    1998-01-01

    This work tries to justify the hydrodynamic butterfly valves performance, using the EPRI tests, results carried out in laboratory and in situ. This justification will be possible if: - The valves to study are similar - Their performance is calculated using EPRI's methodology Looking for this objective, the elements of the present work are: 1. Brief EPRI butterfly valve description it wild provide the factors which are necessary to define the butterfly valves similarity. 2. EPRI tests description and range of validation against test data definition. 3. Description of the spanish butterfly analyzed valves, and comparison with the EPRI performance results, to prove that this valves are similar to the EPRI test valves. In this way, it will not be necessary to carry out particular dynamic tests on the spanish valves to describe their hydrodynamic performance. (Author)

  17. Potent corticosteroid cream (mometasone furoate) significantly reduces acute radiation dermatitis: results from a double-blind, randomized study

    International Nuclear Information System (INIS)

    Bostroem, Aasa; Lindman, Henrik; Swartling, Carl; Berne, Berit; Bergh, Jonas

    2001-01-01

    Purpose: Radiation-induced dermatitis is a very common side effect of radiation therapy, and may necessitate interruption of the therapy. There is a substantial lack of evidence-based treatments for this condition. The aim of this study was to investigate the effect of mometasone furoate cream (MMF) on radiation dermatitis in a prospective, double-blind, randomized study. Material and methods: The study comprised 49 patients with node-negative breast cancer. They were operated on with sector resection and scheduled for postoperative radiotherapy using photons with identical radiation qualities and dosage to the breast parenchyma. The patients were randomized to receive either MMF or emollient cream. The cream was applied on the irradiated skin twice a week from the start of radiotherapy until the 12th fraction (24 Gy) and thereafter once daily until 3 weeks after completion of radiation. Both groups additionally received non-blinded emollient cream daily. The intensity of the acute radiation dermatitis was evaluated on a weekly basis regarding erythema and pigmentation, using a reflectance spectrophotometer together with visual scoring of the skin reactions. Results: MMF in combination with emollient cream treatment significantly decreased acute radiation dermatitis (P=0.0033) compared with emollient cream alone. There was no significant difference in pigmentation between the two groups. Conclusions: Adding MMF, a potent topical corticosteroid, to an emollient cream is statistically significantly more effective than emollient cream alone in reducing acute radiation dermatitis

  18. The IDvIP Trial: A two-centre randomised double-blind controlled trial comparing intramuscular diamorphine and intramuscular pethidine for labour analgesia

    Directory of Open Access Journals (Sweden)

    Thomas Peter

    2011-07-01

    Full Text Available Abstract Background Intramuscular pethidine is routinely used throughout the UK for labour analgesia. Studies have suggested that pethidine provides little pain relief in labour and has a number of side effects affecting mother and neonate. It can cause nausea, vomiting and dysphoria in mothers and can cause reduced fetal heart rate variability and accelerations. Neonatal effects include respiratory depression and impaired feeding. There are few large studies comparing the relative side effects and efficacy of different opioids in labour. A small trial comparing intramuscular pethidine with diamorphine, showed diamorphine to have some benefits over pethidine when used for labour analgesia but the study did not investigate the adverse effects of either opioid. Methods The Intramuscular Diamorphine versus Intramuscular Pethidine (IDvIP trial is a randomised double-blind two centre controlled trial comparing intramuscular diamorphine and pethidine regarding their analgesic efficacy in labour and their side effects in mother, fetus and neonate. Information about the trial will be provided to women in the antenatal period or in early labour. Consent and recruitment to the trial will be obtained when the mother requests opioid analgesia. The sample size requirement is 406 women with data on primary outcomes. The maternal primary outcomes are pain relief during the first 3 hours after trial analgesia and specifically pain relief after 60 minutes. The neonatal primary outcomes are need for resuscitation and Apgar Score Discussion If the trial demonstrates that diamorphine provides better analgesia with fewer side effects in mother and neonate this could lead to a change in national practice and result in diamorphine becoming the preferred intramuscular opioid for analgesia in labour. Trial Registration ISRCTN14898678 Eudra No: 2006-003250-18, REC Reference No: 06/Q1702/95, MHRA Authorisation No: 1443/0001/001-0001, NIHR UKCRN reference 6895, RfPB grant

  19. Management of ocular trauma in emergency (MOTE trial: A pilot randomized double-blinded trial comparing topical amethocaine with saline in the outpatient management of corneal trauma

    Directory of Open Access Journals (Sweden)

    Ting Joseph

    2009-01-01

    Full Text Available Background: It is unclear whether local anesthetic eye drops can be safely used for the topical anesthesia of patients with minor corneal injury who are discharged from the emergency department (ED. Objectives: To assess whether topical 0.4% amethocaine self-administered to a maximum recommended frequency of once every hour for 36-48 h is safe in the management of uncomplicated corneal injury in patients discharged from the ED. Patients and Methods: A pilot randomized double-blinded trial comparing topical 0.4% amethocaine with topical normal saline. Results: Forty-seven subjects were recruited, with 22 randomized to receive amethocaine and 25 to receive placebo (normal saline . Baseline characteristics, including corneal injury type, were similar in both groups. There were no significant functional or clinical adverse sequelae in the majority of enrolled patients who could be contacted at 2 weeks (17/22 for amethocaine and 21/25 for placebo. Follow-up for the primary study outcome was suboptimal, with only 7/22 from the amethocaine group and 9/25 from the saline group presenting for 36-48 h review; there was a statistically nonsignificant trend for persistence of the corneal defect in the amethocaine group as compared with the saline group (2/7 and 1/9, respectively. Conclusion: Compared with saline drops, amethocaine eye drops are not definitely safe but they are effective for topical analgesia in minor corneal injury. Until further definitive studies, topical nonsteroidal agents or long-lasting artificial tears may be preferred for the topical analgesia of minor corneal injury. Return for corneal re-evaluation will necessarily remain suboptimal in an otherwise self-limiting condition, leading to a bias even if study recruitment is good.

  20. [Pilot study to investigate sleep disorders in the blind and persons with relevant visual impairment].

    Science.gov (United States)

    Dirks, C; Grünewald, D; Young, P; Heidbreder, A

    2018-05-22

    Sleep disorders are associated with serious health problems in blind and visually impaired persons. Loss of light perception may result in a shift of sleep-wake pattern, which may lead to significant impairments in daily life--the so-called non-24-hour sleep-wake disorder. To date, epidemiologic data on non-24 only exist for the USA. This pilot study was conducted to provide first epidemiologic data for the prevalence of non-24 and other sleep disorders among blind and visually impaired persons in Germany. Recruited were 111 blind and visually impaired subjects (36 subjects without light perception; male [m] = 56, 27-85 years, average [Mx] = 59.53, standard deviation [SD] = 14.69) and 111 sighted controls (m = 41, 27-88 years, Mx = 58.32, SD = 14.21), who answered a set of validated questionnaires referring to general health status (SF-36), sleep characteristics (PSQI), and daytime sleepiness (ESS). In addition, a questionnaire to predict non-24-hour sleep-wake disorder, which is not yet validated in German, was provided. The prevalence of 72.2% for the non-24-hour sleep-wake disorder in blind people is in accordance with results from the USA. In contrast, our results indicated non-24 in only 21.3% of the subjects with residual light perception. Furthermore, other sleep disorders like problems falling asleep (100% vs. 79.9%), maintaining sleep (90% vs. 88.1%), sleep-disordered breathing (19.4% vs. 32%), or sleep-related movement disorders (28.1% vs. 32.9%) were also common in the group of blind or visually impaired persons. The non-24-hour sleep-wake disorder is a frequent problem among people with no light perception, associated with problems falling asleep, maintaining sleep, and daytime sleepiness. The perception of light as an external cue for our circadian rhythm plays a key role. However, sleep disruption is not fully explained by non-24, making a detailed sleep history essential.

  1. Causes and emerging trends of childhood blindness: findings from schools for the blind in Southeast Nigeria.

    Science.gov (United States)

    Aghaji, Ada; Okoye, Obiekwe; Bowman, Richard

    2015-06-01

    To ascertain the causes severe visual impairment and blindness (SVI/BL) in schools for the blind in southeast Nigeria and to evaluate temporal trends. All children who developed blindness at schools for the blind in southeast Nigeria were examined. All the data were recorded on a WHO/Prevention of Blindness (WHO/PBL) form entered into a Microsoft Access database and transferred to STATA V.12.1 for analysis. To estimate temporal trends in causes of blindness, older (>15 years) children were compared with younger (≤15 years) children. 124 children were identified with SVI/BL. The most common anatomical site of blindness was the lens (33.9%). Overall, avoidable blindness accounted for 73.4% of all blindness. Exploring trends in SVI/BL between children ≤15 years of age and those >15 years old, this study shows a reduction in avoidable blindness but an increase in cortical visual impairment in the younger age group. The results from this study show a statistically significant decrease in avoidable blindness in children ≤15 years old. Corneal blindness appears to be decreasing but cortical visual impairment seems to be emerging in the younger age group. Appropriate strategies for the prevention of avoidable childhood blindness in Nigeria need to be developed and implemented. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  2. PONV in Ambulatory surgery: A comparison between Ramosetron and Ondansetron: a prospective, double-blinded, and randomized controlled study

    Directory of Open Access Journals (Sweden)

    Debasis Banerjee

    2014-01-01

    Full Text Available Background: postoperative nausea and vomiting (PONV frequently hampers implementation of ambulatory surgery in spite of so many antiemetic drugs and regimens. Aims: the study was carried out to compare the efficacy of Ramosetron and Ondansetron in preventing PONV after ambulatory surgery. Setting and Design: it was a prospective, double blinded, and randomized controlled study. Methods: 124 adult patients of either sex, aged 25-55, of ASA physical status I and II, scheduled for day care surgery, were randomly allocated into Group A [(n=62 receiving (IV Ondansetron (4 mg] and Group B [(n=62 receiving IV Ramosetron (0.3 mg] prior to the induction of general anesthesia in a double-blind manner. Episodes of PONV were noted at 0.5, 1, 2, 4 h, 6 , 12, and 18 h postoperatively. Statistical Analysis and Results: statistically significant difference between Groups A and B (P <0.05 was found showing that Ramosetron was superior to Ondansetron as antiemetic both regarding frequency and severity. Conclusion: it was evident that preoperative prophylactic administration of single dose IV Ramosetron (0.3 mg has better efficacy than single dose IV Ondansetron (4 mg in reducing the episodes of PONV over 18 h postoperatively in patients undergoing day-care surgery under general anesthesia.

  3. Individual differences in fluid intelligence predicts inattentional blindness in a sample of older adults: a preliminary study.

    Science.gov (United States)

    O'Shea, Deirdre M; Fieo, Robert A

    2015-07-01

    Previous research has shown that aging increases susceptibility to inattentional blindness (Graham and Burke, Psychol Aging 26:162, 2011) as well as individual differences in cognitive ability related to working memory and executive functions in separate studies. Therefore, the present study was conducted in an attempt to bridge a gap that involved investigating 'age-sensitive' cognitive abilities that may predict inattentional blindness in a sample of older adults. We investigated whether individual differences in general fluid intelligence and speed of processing would predict inattentional blindness in our sample of older adults. Thirty-six healthy older adults took part in the study. Using the inattentional blindness paradigm developed by Most et al. (Psychol Rev 112:217, 2005), we investigated whether rates of inattentional blindness could be predicted by participant's performance on the Raven's Advanced Progressive Matrices and a choice-reaction time task. A Mann-Whitney U test revealed that a higher score on the Raven's Advanced Progressive Matrices was significantly associated with lower incidences of inattentional blindness. However, a t test revealed that choice-reaction times were not significantly associated with inattentional blindness. Preliminary results from the present study suggest that individual differences in general fluid intelligence are predictive of inattentional blindness in older adults but not speed of processing. Moreover, our findings are consistent with previous studies that have suggested executive attention control may be the source of these individual differences. These findings also highlight the association between attention and general fluid intelligence and how it may impact environmental awareness. Future research would benefit from repeating these analyses in a larger sample and also including a younger comparison group.

  4. Double-blind, placebo-controlled study of dialectical behavior therapy plus olanzapine for borderline personality disorder.

    Science.gov (United States)

    Soler, Joaquim; Pascual, Juan Carlos; Campins, Josefa; Barrachina, Judith; Puigdemont, Dolors; Alvarez, Enrique; Pérez, Victor

    2005-06-01

    The aim of this study was to determine the efficacy and safety of dialectical behavior therapy plus olanzapine compared with dialectical behavior therapy plus placebo in patients with borderline personality disorder. Sixty patients with borderline personality disorder were included in a 12-week, double-blind, placebo-controlled study. All patients received dialectical behavior therapy and were randomly assigned to receive either olanzapine or placebo following a 1-month baseline period. Seventy percent of the patients completed the 4-month trial. Combined treatment showed an overall improvement in most symptoms studied in both groups. Olanzapine was associated with a statistically significant improvement over placebo in depression, anxiety, and impulsivity/aggressive behavior. The mean dose of olanzapine was 8.83 mg/day. A combined psychotherapeutic plus pharmacological approach appears to lower dropout rates and constitutes an effective treatment for borderline personality disorder.

  5. Future trends in global blindness

    Directory of Open Access Journals (Sweden)

    Serge Resnikoff

    2012-01-01

    Full Text Available The objective of this review is to discuss the available data on the prevalence and causes of global blindness, and some of the associated trends and limitations seen. A literature search was conducted using the terms "global AND blindness" and "global AND vision AND impairment", resulting in seven appropriate articles for this review. Since 1990 the estimate of global prevalence of blindness has gradually decreased when considering the best corrected visual acuity definition: 0.71% in 1990, 0.59% in 2002, and 0.55% in 2010, corresponding to a 0.73% reduction per year over the 2002-2010 period. Significant limitations were found in the comparability between the global estimates in prevalence or causes of blindness or visual impairment. These limitations arise from various factors such as uncertainties about the true cause of the impairment, the use of different definitions and methods, and the absence of data from a number of geographical areas, leading to various extrapolation methods, which in turn seriously limit comparability. Seminal to this discussion on limitations in the comparability of studies and data, is that blindness has historically been defined using best corrected visual acuity.

  6. Buspirone Versus Methylphenidate in the Treatment of Children with Attention- Deficit/ Hyperactivity Disorder: Randomized Double-Blind Study

    Directory of Open Access Journals (Sweden)

    Shahin Akhondzadeh

    2012-11-01

    Full Text Available A recent randomized clinical trial showed buspirone efficacy in the treatment of attention-deficit/hyperactivity disorder (ADHD in children. However, results from a recent multi-site controlled clinical trial of transdermal buspirone failed to separate it from placebo in a large sample of children with ADHD. Therefore, due to these inconsistent findings, this study was designed to assess the efficacy of buspirone in the treatment of children with ADHD compared to methylphenidate in a double blind randomized clinical trial. Forty outpatients with a DSM-IV-TR diagnosis of ADHD were study population of this trial. Subjects were recruited from an outpatient child and adolescent clinic for a 6 week double blind, randomized clinical trial. All study subjects were randomly assigned to receive treatment using tablet of buspirone at a dose of 20-30 mg/day depending on weight (20 mg/day for 30kg (group 1 or methylphenidate at a dose of 20-30 mg/day depending on weight (20 mg/day for 30kg (group 2 for a 6 week double blind, randomized clinical trial. The principal measure of outcome was the Teacher and Parent ADHD Rating Scale IV. Patients were assessed at baseline and at 21 and 42 days after the medication started. Significant differences were observed between the two groups on the Parent and Teacher Rating Scale scores. The changes at the endpoint compared to baseline were: -8.95±8.73 (mean±SD and -15.60±7.81 (mean±SD for buspirone and methyphenidate, for Parent ADHD Rating Scale. The changes at the endpoint compared to baseline were: -9.80 ±7.06 (mean±SD and -22.40±9.90 (mean±SD for buspirone and methyphenidate, respectively for Teacher ADHD Rating Scale. The difference between the buspirone and methylphenidate groups in the frequency of side effects was not significant except for decreased appetite, headache and insomnia that were observed more frequently in the methylphenidate group. The results of this study suggest that administration of

  7. "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 o...... 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 (...

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

    Science.gov (United States)

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

    2018-08-01

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

  9. Comparative Study on the Efficacy of Two Regimens of Single-Shot ...

    African Journals Online (AJOL)

    Objective: To assess and compare the satisfaction and efficacy of two regimens of single-shot spinal blocks for the relief of labor pain in women who present in active phase of labour. Design: A prospective randomised single-blind observational study. Setting: Labour ward of Kenyatta National Hospital, Nairobi. Subjects: All ...

  10. Acupuncture point injection treatment of primary dysmenorrhoea: a randomised, double blind, controlled study.

    Science.gov (United States)

    Wade, C; Wang, L; Zhao, W J; Cardini, F; Kronenberg, F; Gui, S Q; Ying, Z; Zhao, N Q; Chao, M T; Yu, J

    2016-01-05

    To determine if injection of vitamin K3 in an acupuncture point is optimal for the treatment of primary dysmenorrhoea, when compared with 2 other injection treatments. A Menstrual Disorder Centre at a public hospital in Shanghai, China. Chinese women aged 14-25 years with severe primary dysmenorrhoea for at least 6 months not relieved by any other treatment were recruited. Exclusion criteria were the use of oral contraceptives, intrauterine devices or anticoagulant drugs, pregnancy, history of abdominal surgery, participation in other therapies for pain and diagnosis of secondary dysmenorrhoea. Eighty patients with primary dysmenorrhoea, as defined on a 4-grade scale, completed the study. Two patients withdrew after randomisation. A double-blind, double-dummy, randomised controlled trial compared vitamin K3 acupuncture point injection to saline acupuncture point injection and vitamin K3 deep muscle injection. Patients in each group received 3 injections at a single treatment visit. The primary outcome was the difference in subjective perception of pain as measured by an 11 unit Numeric Rating Scale (NRS). Secondary measurements were Cox Pain Intensity and Duration scales and the consumption of analgesic tablets before and after treatment and during 6 following cycles. Patients in all 3 groups experienced pain relief from the injection treatments. Differences in NRS measured mean pain scores between the 2 active control groups were less than 1 unit (-0.71, CI -1.37 to -0.05) and not significant, but the differences in average scores between the treatment hypothesised to be optimal and both active control groups (1.11, CI 0.45 to 1.78) and (1.82, CI 1.45 to 2.49) were statistically significant in adjusted mixed-effects models. Menstrual distress and use of analgesics were diminished for 6 months post-treatment. Acupuncture point injection of vitamin K3 relieves menstrual pain rapidly and is a useful treatment in an urban outpatient clinic. NCT00104546; Results

  11. A randomised, double-blind, multi-centre trial comparing vasopressin and adrenaline in patients with cardiac arrest presenting to or in the Emergency Department.

    Science.gov (United States)

    Ong, Marcus Eng Hock; Tiah, Ling; Leong, Benjamin Sieu-Hon; Tan, Elaine Ching Ching; Ong, Victor Yeok Kein; Tan, Elizabeth Ai Theng; Poh, Bee Yen; Pek, Pin Pin; Chen, Yuming

    2012-08-01

    To compare vasopressin and adrenaline in the treatment of patients with cardiac arrest presenting to or in the Emergency Department (ED). A randomised, double-blind, multi-centre, parallel-design clinical trial in four adult hospitals. Eligible cardiac arrest patients (confirmed by the absence of pulse, unresponsiveness and apnea) aged >16 (aged>21 for one hospital) were randomly assigned to intravenous adrenaline (1mg) or vasopressin (40 IU) at ED. Patients with traumatic cardiac arrest or contraindication for cardiopulmonary resuscitation (CPR) were excluded. Patients received additional open label doses of adrenaline as per current guidelines. Primary outcome was survival to hospital discharge (defined as participant discharged alive or survival to 30 days post-arrest). The study recruited 727 participants (adrenaline = 353; vasopressin = 374). Baseline characteristics of the two groups were comparable. Eight participants (2.3%) from adrenaline and 11 (2.9%) from vasopressin group survived to hospital discharge with no significant difference between groups (p = 0.27, RR = 1.72, 95% CI = 0.65-4.51). After adjustment for race, medical history, bystander CPR and prior adrenaline given, more participants survived to hospital admission with vasopressin (22.2%) than with adrenaline (16.7%) (p = 0.05, RR = 1.43, 95% CI = 1.02-2.04). Sub-group analysis suggested improved outcomes for vasopressin in participants with prolonged arrest times. Combination of vasopressin and adrenaline did not improve long term survival but seemed to improve survival to admission in patients with prolonged cardiac arrest. Further studies on the effect of vasopressin combined with therapeutic hypothermia on patients with prolonged cardiac arrest are needed. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  12. Comparative electrocardiographic effects of intravenous ondansetron and granisetron in patients undergoing surgery for carcinoma breast: A prospective single-blind randomised trial

    Directory of Open Access Journals (Sweden)

    Ashish Ganjare

    2013-01-01

    Full Text Available Background: Postoperative nausea and vomiting (PONV are common and distressing symptoms after surgery performed under general anaesthesia. 5-hydroxytryptamine 3 antagonists are routinely used for prevention and treatment of PONV. The aim of our study was to compare the incidence of QTc prolongation and quantify the amount of QTc prolongation with ondansetron and granisetron. Methods: This prospective, randomised, single-blind study was carried out in the OT and Recovery Room (RR of a tertiary referral cancer centre. After obtaining Institutional Review Board approval and written informed consent from the patients, 70 patients undergoing elective surgery for carcinoma breast were included. In the RR, patients randomly received 8 mg of ondansetron or 1 mg of granisetron intravenously. Serial ECGs were recorded at various intervals, Non-invasive blood pressure and SpO 2 were also recorded. Chi-square test and Mann-Whiteny test were used for statistical analysis. Results: The demographics were similar in both groups. The incidence of significant QTc prolongation was significantly higher in the ondansetron group (22 of 37 (59.4% vs. 11 of 33 patients (33.33% ( P<0.05. There was an increase in the QTc interval in both the groups as compared to the baseline. The median prolongation in QTc interval from baseline was much more in the ondansetron group; this was statistically significant only at 5 and 15 min. Conclusion: Granisetron may be a safer option than ondanasetron for prevention and treatment of PONV due to lesser prolongation QTc interval. (ClinicalTrials.gov ID: NCT01352130

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

    Science.gov (United States)

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

    2017-12-13

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

  14. Enhanced tactile encoding and memory recognition in congenital blindness.

    Science.gov (United States)

    D'Angiulli, Amedeo; Waraich, Paul

    2002-06-01

    Several behavioural studies have shown that early-blind persons possess superior tactile skills. Since neurophysiological data show that early-blind persons recruit visual as well as somatosensory cortex to carry out tactile processing (cross-modal plasticity), blind persons' sharper tactile skills may be related to cortical re-organisation resulting from loss of vision early in their life. To examine the nature of blind individuals' tactile superiority and its implications for cross-modal plasticity, we compared the tactile performance of congenitally totally blind, low-vision and sighted children on raised-line picture identification test and re-test, assessing effects of task familiarity, exploratory strategy and memory recognition. What distinguished the blind from the other children was higher memory recognition and higher tactile encoding associated with efficient exploration. These results suggest that enhanced perceptual encoding and recognition memory may be two cognitive correlates of cross-modal plasticity in congenital blindness.

  15. Efficacy and tolerability of topical sertaconazole versus topical terbinafine in localized dermatophytosis: A randomized, observer-blind, parallel group study.

    Science.gov (United States)

    Chatterjee, Dattatreyo; Ghosh, Sudip Kumar; Sen, Sukanta; Sarkar, Saswati; Hazra, Avijit; De, Radharaman

    2016-01-01

    Epidermal dermatophyte infections most commonly manifest as tinea corporis or tinea cruris. Topical azole antifungals are commonly used in their treatment but literature suggests that most require twice-daily application and provide lower cure rates than the allylamine antifungal terbinafine. We conducted a head-to-head comparison of the effectiveness of the once-daily topical azole, sertaconazole, with terbinafine in these infections. We conducted a randomized, observer-blind, parallel group study (Clinical Trial Registry India [CTRI]/2014/09/005029) with adult patients of either sex presenting with localized lesions. The clinical diagnosis was confirmed by potassium hydroxide smear microscopy of skin scrapings. After baseline assessment of erythema, scaling, and pruritus, patients applied either of the two study drugs once daily for 2 weeks. If clinical cure was not seen at 2 weeks, but improvement was noted, application was continued for further 2 weeks. Patients deemed to be clinical failure at 2 weeks were switched to oral antifungals. Overall 88 patients on sertaconazole and 91 on terbinafine were analyzed. At 2 weeks, the clinical cure rates were comparable at 77.27% (95% confidence interval [CI]: 68.52%-86.03%) for sertaconazole and 73.63% (95% CI 64.57%-82.68%) for terbinafine ( P = 0.606). Fourteen patients in either group improved and on further treatment showed complete healing by another 2 weeks. The final cure rate at 4 weeks was also comparable at 93.18% (95% CI 88.75%-97.62%) and 89.01% (95% CI 82.59%-95.44%), respectively ( P = 0.914). At 2 weeks, 6 (6.82%) sertaconazole and 10 (10.99%) terbinafine recipients were considered as "clinical failure." Tolerability of both preparations was excellent. Despite the limitations of an observer-blind study without microbiological support, the results suggest that once-daily topical sertaconazole is as effective as terbinafine in localized tinea infections.

  16. Comparing Formation or Non-Formation of Bladder Flap at Cesarean Section on Perioperative and Postoperative Complications: Double-Blind Clinical Trial

    Directory of Open Access Journals (Sweden)

    Farideh Akhlaghi

    2018-03-01

    Full Text Available Objective: To investigating formation or non-formation of bladder flap at Cesarean section on the complications during and after surgery.Materials and methods: This is a double-blind clinical trial study conducted during February 2014 to May 2015 on 64 pregnant women with gestational age of 36 weeks or more who were delivered by Cesarean section for the first time. They were randomly divided into two groups (intervention group: non-formation of bladder flap; control group: formation of bladder flap. The time to cut out the baby by Cesarean section, total duration of operation, bladder injury, intraoperative bleeding, hematocrit changes expected prior to during and following operation, postoperative pain, macroscopic and microscopic hematuria, postoperative complications and duration of  hospitalization were compared between two groups. The data were analyzed with SPSS version 16 using and statistics tests. p < 0.05 was considered significant.Results: Time to cut out the baby for the intervention group (124.9 ± 40.5 seconds and for control group 155.1 ± 42.9 seconds and total duration of the operation (intervention group: 27.7 ± 5.2 min and control group: 34 ± 4.73 min were significantly different (p = 0.000. Number of gauze consumption during operation and postoperative hematocrit drop in the intervention group was significantly lower in the intervention group compared the control group (p = 0.000. The postoperative pain score in the intervention group (4.8 ± 1.1 and in control group (6.3 ± 0.9 were significantly different (p = 0.000.Conclusion: Omission of the bladder flap at Cesarean section leads to short-term benefits such as reducing the time to cut out the fetus, duration of surgery, decreasing postoperative bleeding and lowering pain.

  17. Comparing the effects of aromatherapy massage and inhalation aromatherapy on anxiety and pain in burn patients: A single-blind randomized clinical trial.

    Science.gov (United States)

    Seyyed-Rasooli, Alehe; Salehi, Feridoon; Mohammadpoorasl, Asghar; Goljaryan, Sakineh; Seyyedi, Zahra; Thomson, Brian

    2016-12-01

    Anxiety and pain are recognized as major problems of burn patients; because pharmaceutical treatments for controlling anxiety and pain symptoms lead to complications and an increase in health costs, nonpharmacological nursing interventions were considered for this group of patients. This led to the present study aimed at comparing the effect of aromatherapy massage with inhalation aromatherapy for anxiety and pain in burn patients. This single-blind clinical trial was carried out on 90 patients with burns aromatherapy massage, inhalation aromatherapy, and control group. The patients assigned to the aromatherapy massage group received a massage for half an hour using a blend of lavender and almond oils, while a blend of rose and lavender aroma was used for the inhalation aromatherapy group. Spielberger State Anxiety Inventory was used for measuring anxiety and the visual analog scale (VAS) scale was used for measuring pain. The results showed that three groups were equal in terms of demographics, disease characteristics, and scores of anxiety and pain at the baseline. The mean decreases of anxiety scores were -0.04±5.08, 6.33±12.55, and 6.43±10.60 in the control group, aromatherapy massage group, and inhalation group, respectively (p=0.007). The mean decrease of pain scores were -0.10±0.96, 1.70±1.84, and 0.97±1.56 in the control group, aromatherapy massage group, and inhalation group, respectively (paromatherapy massage and inhalation aromatherapy compared with the control group in reducing both anxiety and pain of burn patients. Therefore, both interventions, which are inexpensive, and noninvasive nursing tasks can be proposed for alleviating anxiety and pain of burn patients. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

  18. Double-blind placebo-controlled pilot study of paroxetine for specific phobia.

    Science.gov (United States)

    Benjamin, J; Ben-Zion, I Z; Karbofsky, E; Dannon, P

    2000-04-01

    Drugs are not recognized as a standard treatment for specific phobia, despite its apparent similarities to other kinds of phobia. Reluctance on the part of patients and clinicians to see the disorder as more than normal anxiety may explain the apparent resistance to pharmacotherapy. Eleven patients fulfilling DSM-IV criteria for specific phobia were randomized to 4 weeks of double-blind treatment with placebo or paroxetine up to 20 mg/day. They were assessed weekly with the Fear Questionnaire and the Hamilton Rating Scale for Anxiety. Paroxetine showed significant superiority in reducing all measures (ANCOVA for reductions in phobia scores F=7.9, P=0.02). One out of six patients responded to placebo, compared to three out of five patients on paroxetine. This new therapeutic option (i.e. drug treatment) for specific phobia deserves further examination in a larger trial.

  19. [Stimulation of wound healing by tetrachlordecaoxide. Results of a randomized double-blind study].

    Science.gov (United States)

    Hinz, J; Hautzinger, H; Helling, J; Schirren, G; Sell, G; Stahl, K W; Kühne, F W

    1984-05-10

    In 38 patients with chronic therapeutically resistant wounds, which, in 25 cases, had been existing for more than one year, Tetrachlorodecaoxide ( TCDO ) in a water solution containing glycerin was analyzed for its capacity to induce wound healing and compared in this respect to the standard in moist wound treatment, physiological sodium chloride. The results of the clinical trial demonstrate that the TCDO solution is significantly superior to physiological saline in local wound treatment regarding the degree of wound smear reduction, the formation of wound granulation tissue, the stimulation of epithelisation on the wound borders and the shrinking of the wound surface. The differences in therapeutic efficiency are so large that, in spite of the relatively small patient samples (21 + 17) it was possible to verify the superiority of a method for wound treatment in a randomized double blind clinical trial.

  20. Impact of visual learning on facial expressions of physical distress: a study on voluntary and evoked expressions of pain in congenitally blind and sighted individuals.

    Science.gov (United States)

    Kunz, Miriam; Faltermeier, Nicole; Lautenbacher, Stefan

    2012-02-01

    The ability to facially communicate physical distress (e.g. pain) can be essential to ensure help, support and clinical treatment for the individual experiencing physical distress. So far, it is not known to which degree this ability represents innate and biologically prepared programs or whether it requires visual learning. Here, we address this question by studying evoked and voluntary facial expressions of pain in congenitally blind (N=21) and sighted (N=42) individuals. The repertoire of evoked facial expressions was comparable in congenitally blind and sighted individuals; however, blind individuals were less capable of facially encoding different intensities of experimental pain. Moreover, blind individuals were less capable of voluntarily modulating their pain expression. We conclude that the repertoire of facial muscles being activated during pain is biologically prepared. However, visual learning is a prerequisite in order to encode different intensities of physical distress as well as for up- and down-regulation of one's facial expression. Copyright © 2011 Elsevier B.V. All rights reserved.

  1. A double-blind, placebo-controlled study of risperidone in adults with autistic disorder and other pervasive developmental disorders.

    Science.gov (United States)

    McDougle, C J; Holmes, J P; Carlson, D C; Pelton, G H; Cohen, D J; Price, L H

    1998-07-01

    Neurobiological research has implicated the dopamine and serotonin systems in the pathogenesis of autism. Open-label reports suggest that the serotonin2A-dopamine D2 antagonist risperidone may be safe and effective in reducing the interfering symptoms of patients with autism. Thirty-one adults (age [mean+/-SD], 28.1+/-7.3 years) with autistic disorder (n=17) or pervasive developmental disorder not otherwise specified (n=14) participated in a 12-week double-blind, placebo-controlled trial of risperidone. Patients treated with placebo subsequently received a 12-week open-label trial of risperidone. For persons completing the study, 8 (57%) of 14 patients treated with risperidone were categorized as responders (daily dose [mean+/-SD], 2.9+/-1.4 mg) compared with none of 16 in the placebo group (Pautism (Pautism in adults.

  2. Safety of a New Compact Male Intermittent Catheter: Randomized, Cross-Over, Single-Blind Study in Healthy Male Volunteers

    DEFF Research Database (Denmark)

    Bagi, Per; Hannibalsen, Jane; Permild, Rikke

    2011-01-01

    in hematuria (p = 0.54) or discomfort/stinging/pain at first micturition (p = 0.56). During insertion, handling was easier (p = 0.0001) and touching the coating was necessary less often (2.2 vs. 81.3% of catheterizations; p catheter; it was preferred by nurses for 20 of 23......Introduction: A new compact male intermittent catheter was compared with a regular intermittent male catheter in terms of safety and acceptability. Methods: In this randomized, single-blind, cross-over study, healthy male volunteers were catheterized twice with a compact catheter and twice...... with a regular catheter. Results: 28 participants were enrolled. Mean ± SD discomfort (visual analogue scale; primary objective) was 2.25 ± 1.5 and 2.52 ± 1.8 for the compact and regular catheters, respectively (difference -0.27; 95% confidence interval -0.73 to 0.19); there was no significant difference...

  3. The effect of levetiracetam on focal nocturnal epileptiform activity during sleep--a placebo-controlled double-blind cross-over study.

    Science.gov (United States)

    Larsson, Pål Gunnar; Bakke, Kristin A; Bjørnæs, Helge; Heminghyt, Einar; Rytter, Elisif; Brager-Larsen, Line; Eriksson, Ann-Sofie

    2012-05-01

    Electric Status Epilepticus during Sleep (ESES) occurs in children with and without epilepsy. It may be related to disturbances as autism spectrum disorder, attention-deficit hyperactivity disorder and acquired aphasia (Landau-Kleffner syndrome). Antiepileptic drug (AED) treatment has been reported in small studies without placebo control. This study was designed to assess AED effect in a placebo-controlled double-blind cross-over study. Levetiracetam (LEV) was chosen based on clinical evidence. Eighteen patients fulfilled the inclusion criteria. The mean spike index at baseline was 56, falling to a mean of 37 at the end of the LEV treatment period. Assessed with a 2-way ANOVA, there is a significant treatment effect (pdouble-blind cross-over study for any AED in patients with ESES. The effect of LEV is comparable with its effect in treatment of epileptic seizures. Copyright © 2012 Elsevier Inc. All rights reserved.

  4. Effect of Dill (Anethum graveolens on the severity of primary dysmenorrhea in compared with mefenamic acid: A randomized, double-blind trial

    Directory of Open Access Journals (Sweden)

    Reza Heidarifar

    2014-01-01

    Full Text Available Background: Dysmenorrhea has negative effects on women′s life. Due to side-effects of chemical drugs, there is growing trend toward herbal medicine. The aim of this study was to assess the effect of Dill compared to mefenamic acid on primary dysmenorrhea. Materials and Methods: This double-blind, randomized, clinical trial study was conducted on 75 single female students between 18 and 28 years old educating in Nursing and Midwifery School and Paramedical Faculty of Qom University of Medical Sciences of Iran in 2011. They were allocated randomly into one of the three groups: In Dill group, they took 1000 mg of Dill powder q12h for 5 days from 2 days before the beginning of menstruation for two cycles. Other groups received 250 mg mefenamic acid or 500 mg starch capsule as placebo, respectively. Dysmenorrhea severity was determined by a verbal multidimensional scoring system and a visual analog scale (VAS. Students with mild dysmenorrhea were excluded. Data were analyzed by SPSS using the descriptive statistic, paired-samples t-test, Wilcoxon signed-rank test, Mann-Whitney test, and Kruskal-Wallis test. Results: There were no significant differences between three groups for demographic or descriptive variables. Comprising the VAS showed that the participants of Dill and mefenamic acid groups had lower significant pain in the 1 st and the 2 nd months after treatment, whereas in the placebo group this was only significant in the 2 nd month (P < 0.05. Conclusion: Dill was as effective as mefenamic acid in reducing the pain severity in primary dysmenorrhea. Further studies regarding side-effects of Dill and its interactivity are recommended.

  5. The sensory construction of dreams and nightmare frequency in congenitally blind and late blind individuals

    DEFF Research Database (Denmark)

    Meaidi, Amani; Jennum, Poul; Ptito, Maurice

    2014-01-01

    and anxiety levels. RESULTS: All blind participants had fewer visual dream impressions compared to SC participants. In LB participants, duration of blindness was negatively correlated with duration, clarity, and color content of visual dream impressions. CB participants reported more auditory, tactile......OBJECTIVES: We aimed to assess dream content in groups of congenitally blind (CB), late blind (LB), and age- and sex-matched sighted control (SC) participants. METHODS: We conducted an observational study of 11 CB, 14 LB, and 25 SC participants and collected dream reports over a 4-week period......, gustatory, and olfactory dream components compared to SC participants. In contrast, LB participants only reported more tactile dream impressions. Blind and SC participants did not differ with respect to emotional and thematic dream content. However, CB participants reported more aggressive interactions...

  6. Intra-Articular, Single-Shot Hylan G-F 20 Hyaluronic Acid Injection Compared with Corticosteroid in Knee Osteoarthritis: A Double-Blind, Randomized Controlled Trial.

    Science.gov (United States)

    Tammachote, Nattapol; Kanitnate, Supakit; Yakumpor, Thanasak; Panichkul, Phonthakorn

    2016-06-01

    The treatment of knee osteoarthritis with hyaluronic acid or corticosteroid injection has been widely used. The purpose of this study was to compare the efficacy of hyaluronic acid (hylan G-F 20) with triamcinolone acetonide as a single intra-articular injection for knee osteoarthritis. This study was a prospective, randomized, double-blind clinical trial. Participants with symptomatic knee osteoarthritis were recruited. They were randomized to receive a single-shot, intra-articular injection of either 6 mL of hylan G-F 20 or 6 mL of a solution comprising 1 mL of 40-mg triamcinolone acetonide and 5 mL of 1% lidocaine with epinephrine. The primary outcomes were knee pain severity, knee function, and range of motion at 6 months. Ninety-nine patients were assessed before injection and underwent a 6-month follow-up. Patients and evaluators were blinded. Multilevel regression models were used to estimate differences between the groups. At the 6-month follow-up, compared with patients who took hylan G-F 20, patients who took triamcinolone acetonide had similar improvement in knee pain, knee function, and range of motion. The difference in mean outcome scores between groups was, with regard to knee pain, a visual analog scale (VAS) score of 3 points (95% confidence interval [95% CI], -6 to 11 points); with regard to knee function, a modified Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score of 0 points (95% CI, -8 to 6 points); and, with regard to range of motion, flexion of -1° (95% CI, -5° to 2°) and extension of 0° (95% CI, -0.5° to 0.5°). However, patients who took triamcinolone acetonide had better pain improvement from 24 hours until 1 week after injection; the mean difference between groups with regard to the VAS score was 12 points (95% CI, 5 to 20 points; p = 0.002) at 24 hours and 9 points (95% CI, 1 to 15 points; p = 0.018) at 1 week. At 2 weeks after injection, patients who took triamcinolone acetonide also had better knee

  7. Effects of a soy-based dietary supplement compared with low-dose hormone therapy on the urogenital system: a randomized, double-blind, controlled clinical trial.

    Science.gov (United States)

    Carmignani, Lucio O; Pedro, Adriana Orcesi; Montemor, Eliana B; Arias, Victor A; Costa-Paiva, Lucia H; Pinto-Neto, Aarão M

    2015-07-01

    This study aims to compare the effects of a soy-based dietary supplement, low-dose hormone therapy (HT), and placebo on the urogenital system in postmenopausal women. In this double-blind, randomized, placebo-controlled trial, 60 healthy postmenopausal women aged 40 to 60 years (mean time since menopause, 4.1 y) were randomized into three groups: a soy dietary supplement group (90 mg of isoflavone), a low-dose HT group (1 mg of estradiol plus 0.5 mg of norethisterone), and a placebo group. Urinary, vaginal, and sexual complaints were evaluated using the urogenital subscale of the Menopause Rating Scale. Vaginal maturation value was calculated. Transvaginal sonography was performed to evaluate endometrial thickness. Genital bleeding pattern was assessed. Statistical analysis was performed using χ(2) test, Fisher's exact test, paired Student's t test, Kruskal-Wallis test, Kruskal-Wallis nonparametric test, and analysis of variance. For intergroup comparisons, Kruskal-Wallis nonparametric test (followed by Mann-Whitney U test) was used. Vaginal dryness improved significantly in the soy and HT groups (P = 0.04). Urinary and sexual symptoms did not change with treatment in the three groups. After 16 weeks of treatment, there was a significant increase in maturation value only in the HT group (P < 0.01). Vaginal pH decreased only in this group (P < 0.01). There were no statistically significant differences in endometrial thickness between the three groups, and the adverse effects evaluated were similar. This study shows that a soy-based dietary supplement used for 16 weeks fails to exert estrogenic action on the urogenital tract but improves vaginal dryness.

  8. Physics studies in Europe; a comparative study

    NARCIS (Netherlands)

    Steenstrup, S; dalle Rose, LFD; Jones, WG; Tugulea, L; van Steenwijk, FJ

    What are the differences and similarities between physics studies at different universities across Europe (here the definition of Europe is broad)? How much does a student have to work to obtain a degree in physics? Questions like those prompted EUPEN (European Physics Education Network) to make a

  9. Prophylactic use of pregabalin for prevention of succinylcholine-induced fasciculation and myalgia: a randomized, double-blinded, placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Vinit K. Srivastava

    2016-04-01

    Full Text Available ABSTRACT BACKGROUND: Succinylcholine is commonly used to achieve profound neuromuscular blockade of rapid onset and short duration. OBJECTIVE: The present study compared the efficacy of pregabalin for prevention of succinylcholine-induced fasciculation and myalgia. DESIGN: Prospective, randomized, placebo controlled, double blinded study. MATERIALS AND METHODS: Patients of both genders undergoing elective spine surgery were randomly assigned to two groups. Patients in Group P (pregabalin group received 150 mg of pregabalin orally 1 h prior to induction of anesthesia with sips of water and patients in Group C (control group received placebo. Anesthesia was induced with fentanyl 1.5 mcg/kg, propofol 1.5-2.0 mg/kg followed by succinylcholine 1.5 mg/kg. The intensity of fasciculations was assessed by an observer blinded to the group allotment of the patient on a 4-point scale. A blinded observer recorded postoperative myalgia grade after 24 h of surgery. Patients were provided patient-controlled analgesia with fentanyl for postoperative pain relief. RESULTS: Demographic data of both groups were comparable (p > 0.05. The incidence of muscle fasciculation's was not significant between two groups (p = 0.707, while more patients in group C had moderate to severe fasciculation's compared to group P (p = 0.028. The incidence and severity of myalgia were significantly lower in group P (p < 0.05. CONCLUSION: Pregabalin 150 mg prevents succinylcholine-induced fasciculations and myalgia and also decreases the fentanyl consumption in elective sine surgery.

  10. Effect of commercial breakfast fibre cereals compared with corn flakes on postprandial blood glucose, gastric emptying and satiety in healthy subjects: a randomized blinded crossover trial

    Directory of Open Access Journals (Sweden)

    Almér Lars-Olof

    2007-09-01

    Full Text Available Abstract Background Dietary fibre food intake is related to a reduced risk of developing diabetes mellitus. However, the mechanism of this effect is still not clear. The aim of this study was to evaluate the effect of commercial fibre cereals on the rate of gastric emptying, postprandial glucose response and satiety in healthy subjects. Methods Gastric emptying rate (GER was measured by standardized real time ultrasonography. Twelve healthy subjects were assessed using a randomized crossover blinded trial. The subjects were examined after an 8 hour fast and after assessment of normal fasting blood glucose level. Satiety scores were estimated and blood glucose measurements were taken before and at 0, 20, 30, 40, 60, 80, 100 and 120 min after the end of the meal. GER was calculated as the percentage change in the antral cross-sectional area 15 and 90 min after ingestion of sour milk with corn flakes (GER1, cereal bran flakes (GER2 or wholemeal oat flakes (GER3. Results The median value was, respectively, 42% for GER1, 33 % for GER2 and 51% for GER3. The difference between the GER after ingestion of bran flakes compared to wholemeal oat flakes was statistically significant (p = 0.023. The postprandial delta blood glucose level was statistically significantly lower at 40 min (p = 0.045 and 120 min (p = 0.023 after the cereal bran flakes meal. There was no statistical significance between the areas under the curve (AUCs of the cereals as far as blood glucose and satiety were concerned. Conclusion The result of this study demonstrates that the intake of either bran flakes or wholemeal oat flakes has no effect on the total postprandial blood glucose response or satiety when compared to corn flakes. However, the study does show that the intake of cereal bran flakes slows the GER when compared to oat flakes and corn flakes, probably due to a higher fibre content. Since these products do not differ in terms of glucose response and satiety on healthy

  11. The IDvIP trial: a two-centre randomised double-blind controlled trial comparing intramuscular diamorphine and intramuscular pethidine for labour analgesia.

    Science.gov (United States)

    Wee, Michael Y K; Tuckey, Jenny P; Thomas, Peter; Burnard, Sara

    2011-07-08

    Intramuscular pethidine is routinely used throughout the UK for labour analgesia. Studies have suggested that pethidine provides little pain relief in labour and has a number of side effects affecting mother and neonate. It can cause nausea, vomiting and dysphoria in mothers and can cause reduced fetal heart rate variability and accelerations. Neonatal effects include respiratory depression and impaired feeding. There are few large studies comparing the relative side effects and efficacy of different opioids in labour. A small trial comparing intramuscular pethidine with diamorphine, showed diamorphine to have some benefits over pethidine when used for labour analgesia but the study did not investigate the adverse effects of either opioid. The Intramuscular Diamorphine versus Intramuscular Pethidine (IDvIP) trial is a randomised double-blind two centre controlled trial comparing intramuscular diamorphine and pethidine regarding their analgesic efficacy in labour and their side effects in mother, fetus and neonate. Information about the trial will be provided to women in the antenatal period or in early labour. Consent and recruitment to the trial will be obtained when the mother requests opioid analgesia. The sample size requirement is 406 women with data on primary outcomes. The maternal primary outcomes are pain relief during the first 3 hours after trial analgesia and specifically pain relief after 60 minutes. The neonatal primary outcomes are need for resuscitation and Apgar Score analgesia, whether method of analgesia would be used again, use of Entonox, umbilical arterial and venous pH, fetal heart rate, meconium staining, time from delivery to first breath, Apgar scores at 5 mins, naloxone requirement, transfer to neonatal intensive care unit, neonatal haemoglobin oxygen saturation at 30, 60, 90, and 120 mins after delivery, and neonatal sedation and feeding behaviour during first 2 hours. If the trial demonstrates that diamorphine provides better analgesia

  12. A functional neuroimaging study of sound localization: visual cortex activity predicts performance in early-blind individuals.

    Directory of Open Access Journals (Sweden)

    Frédéric Gougoux

    2005-02-01

    Full Text Available Blind individuals often demonstrate enhanced nonvisual perceptual abilities. However, the neural substrate that underlies this improved performance remains to be fully understood. An earlier behavioral study demonstrated that some early-blind people localize sounds more accurately than sighted controls using monaural cues. In order to investigate the neural basis of these behavioral differences in humans, we carried out functional imaging studies using positron emission tomography and a speaker array that permitted pseudo-free-field presentations within the scanner. During binaural sound localization, a sighted control group showed decreased cerebral blood flow in the occipital lobe, which was not seen in early-blind individuals. During monaural sound localization (one ear plugged, the subgroup of early-blind subjects who were behaviorally superior at sound localization displayed two activation foci in the occipital cortex. This effect was not seen in blind persons who did not have superior monaural sound localization abilities, nor in sighted individuals. The degree of activation of one of these foci was strongly correlated with sound localization accuracy across the entire group of blind subjects. The results show that those blind persons who perform better than sighted persons recruit occipital areas to carry out auditory localization under monaural conditions. We therefore conclude that computations carried out in the occipital cortex specifically underlie the enhanced capacity to use monaural cues. Our findings shed light not only on intermodal compensatory mechanisms, but also on individual differences in these mechanisms and on inhibitory patterns that differ between sighted individuals and those deprived of vision early in life.

  13. Liberal Versus Restrictive Fluid Management in Knee Arthroplasty: A Randomized, Double-Blind Study

    DEFF Research Database (Denmark)

    Holte, Kathrine; Kristensen, Billy Bjarne; Valentiner, Lotte

    2007-01-01

    BACKGROUND: There are few data describing the relationship between amount of perioperative fluid and organ function. In this study we investigated the effects of two levels of intravascular fluid administration ("liberal" versus "restrictive") in knee arthroplasty on physiological recovery...... with a standardized volume of colloid. All other aspects of perioperative management (including anesthesia, preoperative fluid status, and postoperative management) were standardized. Primary outcome variables included pulmonary function (spirometry), exercise capacity ("timed up and go" test), coagulation...... as the primary outcome variable. METHODS: In a double-blind study, 48 ASA I-III patients undergoing fast-track elective knee arthroplasty were randomized to restrictive or liberal perioperative intravascular fluid administration. Patients received a fixed rate infusion of Ringer's lactate solution...

  14. Pterygium excision with or without postoperative irradiation, a double-blind study

    Energy Technology Data Exchange (ETDEWEB)

    de Keizer, R.J.W. (Amsterdam Univ. (Netherlands). Academisch Ziekenhuis)

    1982-01-29

    A double-blind study (covering 40 months) of 40 eyes with a pterygium which had not previously been operated on, was carried out to study the effect of post-operative irradiation. Nineteen eyes were treated by the 'bare sclera' operation technique only and in 13 cases (68%) a recurrence occurred within 4 months. In 18 eyes from the group of patients treated with Sr 90 irradiation on the 1st, 7th and 14th postoperative day (maximum 3 x 1000 rad) no recurrences were seen. Patients with a recurrent pterygium and diplopia, symblepharon, visual disturbances (growth over the pupil or severe astigmatism) or many previous operations, were treated by lamellar keratoplasty (Dake, 1980). The recurrences without these complications were treated with success by the 'bare sclera' technique and postoperative irradiation. Complications did not occur in any of the series.

  15. Familiar trespassers in histopathology: An obstacle in diagnosis? A single-blind study

    Directory of Open Access Journals (Sweden)

    P Shashikala

    2017-01-01

    Full Text Available Background: Histopathologists encounter strange structures in tissue sections that appear unrelated to tissues, and these artifacts may be misinterpreted and misdiagnosed as pathological lesions. These substances may either be present within the tissues or can get implanted into tissue during biopsy procedure or laboratory handling or processing. Aims: The aim of this study is to observe the microscopic appearance of different abnormal structures like commonly implanted food particles or easily incorporated substances during tissue processing with their probable histological misdiagnosis. Materials and Methods: Certain food particles, suture materials, wood pieces, insects, and filter paper were intentionally introduced in the tissue specimens of uterus and lung. Following routine processing and hematoxylin and eosin staining, the slides were subjected to single-blind study and viewed under light and polarizing microscope. Results: The vivid appearances of these structures lead to histological misdiagnosis. Conclusion: Knowledge and familiarity of these commonly encountered extraneous substances will help to prevent misinterpretation.

  16. Pregabalin for anxiety in patients with schizophrenia - A randomized, double-blind placebo-controlled study

    DEFF Research Database (Denmark)

    Schjerning, Ole; Damkier, Per; Lykkegaard, Signe Engelhardt

    2017-01-01

    INTRODUCTION: Anxiety is frequent in patients with schizophrenia and poses a major impact on patients perceived quality of life, daily functioning and risk of suicide. Pregabalin has shown effective in the treatment of generalized anxiety disorder and has been suggested for the treatment of anxiety...... in patients with schizophrenia. As evidence is sparse regarding treatment of anxiety in this patient group, we aimed to investigate the use of pregabalin for anxiety in patients with schizophrenia. METHODS: A randomized, double-blind placebo controlled study was used. Patients were randomized to either...... placebo or pregabalin (≤600mg/d) as add-on treatment. Primary analyses were intention-to-treat based with change in Hamilton Anxiety Scale after 4 and 8weeks of treatment as primary outcome. Secondary outcomes were change in psychopathology, quality-of-life, cognitive functioning and sleep. The study used...

  17. Comparative study between iohexol and iopromide for aortofemoral arteriography

    International Nuclear Information System (INIS)

    Vlahos, L.; Dimakakos, P.; Moulopoulou, A.; Drivas, G.; Keysser, R.; Papavasiliou, C.; Schering A.G., Berlin

    1987-01-01

    A double-blind clinical trial was performed on 50 patients in order to compare omnipague (iohexol) and Ultravist-300 (iopromide) for peripheral arteriography. Both contrast media were well tolerated, but there was less body heat and pain in the Ultravist group. There were no idiosyncratic reactions or significant changes in blood pressure before and after the injection. (orig.) [de

  18. Comparative study between iohexol and iopromide for aortofemoral arteriography

    Energy Technology Data Exchange (ETDEWEB)

    Vlahos, L.; Dimakakos, P.; Moulopoulou, A.; Drivas, G.; Keysser, R.; Papavasiliou, C.

    1987-12-01

    A double-blind clinical trial was performed on 50 patients in order to compare omnipague (iohexol) and Ultravist-300 (iopromide) for peripheral arteriography. Both contrast media were well tolerated, but there was less body heat and pain in the Ultravist group. There were no idiosyncratic reactions or significant changes in blood pressure before and after the injection.

  19. A double-blind randomized controlled trial comparing dexamethasone and clonidine as adjuvants to a ropivacaine sciatic popliteal block for foot surgery

    Directory of Open Access Journals (Sweden)

    Vermeylen K

    2016-05-01

    Full Text Available Kris Vermeylen,1 Joris De Puydt,2 Stefan Engelen,3 Eva Roofthooft,3 Filiep Soetens,1 Arne Neyrinck,4 Marc Van de Velde4 1Department of Anesthesia and Intensive Care, AZ Turnhout, Turnhout, 2Department of Anesthesia, University Hospital Antwerp, Antwerp, 3Department of Anesthesia, ZNA Hospital Network Antwerp, Antwerp, 4Department of Cardiovascular Sciences and Anesthesiology, Catholic University Hospitals, Louvain, Belgium Background and aims: A popliteal block is effective in managing postoperative pain for foot surgery, but since the duration of analgesia is limited following a single-shot popliteal fossa block technique, methods to prolong effective postoperative analgesia are mandatory. The aim of this study was to assess the effect of adjuvants to ropivacaine on the duration of sensory and motor block.Methods: In this double-blind randomized placebo-controlled study, we evaluated the analgesic effect of clonidine or dexamethasone (DXM when added to ropivacaine for hallux valgus surgery. After obtaining institutional ethics research board approval and written informed consent, a total of 72 patients were randomly allocated. Fifty-seven of these patients were statistically analyzed. All patients received an ultrasound-guided single-shot popliteal fossa block with 30 mL of ropivacaine 0.75%, supplemented with saline, clonidine 100 µg, or DXM 5 mg. The primary end point was time to first pain sensation. Secondary end points were time to complete sensory and motor block regression.Results: Compared to saline, duration to first pain sensation was prolonged by 9 hours (mean ± standard deviation: 31±9 hours (42% in the DXM group (P=0.024 and by 6 hours (28±10 hours (27% in the clonidine group (P=0.024. Compared to saline, DXM prolonged both complete sensory and motor blockade by 12 hours (25±7 hours (46% and 13 hours (36±6 hours (55%, respectively, while clonidine prolonged complete sensory and motor blockade by 7 hours (30±7 hours (27% and

  20. A double-blind, randomized, multicenter phase 2 study of prasugrel versus placebo in adult patients with sickle cell disease

    Directory of Open Access Journals (Sweden)

    Wun Ted

    2013-02-01

    Full Text Available Abstract Background Platelet activation has been implicated in the pathogenesis of sickle cell disease (SCD suggesting antiplatelet agents may be therapeutic. To evaluate the safety of prasugrel, a thienopyridine antiplatelet agent, in adult patients with SCD, we conducted a double-blind, randomized, placebo-controlled study. Methods The primary endpoint, safety, was measured by hemorrhagic events requiring medical intervention. Patients were randomized to prasugrel 5 mg daily (n = 41 or placebo (n = 21 for 30 days. Platelet function by VerifyNow® P2Y12 and vasodilator-stimulated phosphoprotein assays at days 10 and 30 were significantly inhibited in prasugrel- compared with placebo-treated SCD patients. Results There were no hemorrhagic events requiring medical intervention in either study arm. Mean pain rate (percentage of days with pain and intensity in the prasugrel arm were decreased compared with placebo. However, these decreases did not reach statistical significance. Platelet surface P-selectin and plasma soluble P-selectin, biomarkers of in vivo platelet activation, were significantly reduced in SCD patients receiving prasugrel compared with placebo. In sum, prasugrel was well tolerated and not associated with serious hemorrhagic events. Conclusions Despite the small size and short duration of this study, there was a decrease in platelet activation biomarkers and a trend toward decreased pain.

  1. A double-blind study of the efficacy of apomorphine and its assessment in "off-periods in Parkinson's disease

    NARCIS (Netherlands)

    van Laar, T.; Jansen, E.N.H.; Essink, A.W.G.; Neef, C.; Oosterloo, Sebe J.

    1993-01-01

    Five patients with idiopathic Parkinson's disease with severe response fluctuations were selected for a randomized double-blind placebo-controlled study, concerning the clinical effects of subcutaneous apomorphine and its assessment in `off¿-periods. The study was designed as five n = 1 studies, in

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

    NARCIS (Netherlands)

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

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

  3. A Virtual Environment for People Who Are Blind - A Usability Study.

    Science.gov (United States)

    Lahav, O; Schloerb, D W; Kumar, S; Srinivasan, M A

    2012-01-01

    For most people who are blind, exploring an unknown environment can be unpleasant, uncomfortable, and unsafe. Over the past years, the use of virtual reality as a learning and rehabilitation tool for people with disabilities has been on the rise. This research is based on the hypothesis that the supply of appropriate perceptual and conceptual information through compensatory sensorial channels may assist people who are blind with anticipatory exploration. In this research we developed and tested the BlindAid system, which allows the user to explore a virtual environment. The two main goals of the research were: (a) evaluation of different modalities (haptic and audio) and navigation tools, and (b) evaluation of spatial cognitive mapping employed by people who are blind. Our research included four participants who are totally blind. The preliminary findings confirm that the system enabled participants to develop comprehensive cognitive maps by exploring the virtual environment.

  4. What is Color Blindness?

    Science.gov (United States)

    ... Color Blindness? Who Is at Risk for Color Blindness? Color Blindness Causes Color Blindness Diagnosis and Treatment How Color Blindness Is Tested What Is Color Blindness? Leer en Español: ¿Qué es el daltonismo? Written ...

  5. Randomized, interventional, prospective, comparative study to ...

    African Journals Online (AJOL)

    Randomized, interventional, prospective, comparative study to evaluate the antihypertensive efficacy and tolerability of ramipril versus telmisartan in stage 1 hypertensive patients with diabetes mellitus.

  6. Does granisetron eliminate the gag reflex? A crossover, double-blind, placebo-controlled pilot study.

    Science.gov (United States)

    Barenboim, Silvina Friedlander; Dvoyris, Vladislav; Kaufman, Eliezer

    2009-01-01

    Although gagging is a frequent problem that, when severe, can jeopardize the dental procedure, no single protocol is used to alleviate this phenomenon. Selective 5-HT3 antagonists, such as granisetron, may attenuate gagging. In this study, granisetron and placebo were administered intravenously, in a crossover, double-blind manner, to 25 healthy volunteers in 2 different sessions. Gagging levels were recorded before and after administration, as were BP, pulse, and O2 saturation. Recorded results were analyzed with the use of tests for nonparametric values (P = .05). A significant increase in the depth of swab insertion was noted after administration of both placebo and drug. The increase in drug effectiveness correlated with decreased body weight. The true efficacy of granisetron in gagger patients with this treatment protocol has yet to be fully established, although it has been theorized that an increased dosage of granisetron may have a better effect.

  7. Benzodiazepine receptor distribution and cerebral blood flow in early blindness. A PET study

    International Nuclear Information System (INIS)

    Mishina, Masahiro; Senda, Michio; Kiyosawa, Motohiro

    2000-01-01

    We studied benzodiazepine receptor (BZR) distribution, which is thought to be affected by neuronal density in the cerebral cortex, and CBF using [ 11 C]flumazenil and [ 15 O]water PET in early blind (EB) and in blindfold sighted control (SC) subjects. PET images were co-registered to the subject's MRI. Using SPM96, MRI images were normalized in the Talairach and Tournoux coordinate system, and accordingly MRI-registered PET images were spatially normalized. Statistical parametric maps were computed on a voxel-by-voxel basis, using the general linear model. CBF for EB was significantly larger in the Brodmann area 17 and 18, especially anterior area, than that for SC, while there was no significant difference in BZR distribution. Our BZR data suggest that the amount of neurons do not change due to early visual deprivation in the visual cortex, in spite of high CBF in visual cortex of EB subjects. (author)

  8. Progression to Legal Blindness in Patients With Normal Tension Glaucoma: Hospital-Based Study.

    Science.gov (United States)

    Sawada, Akira; Rivera, Jonathan A; Takagi, Daisuke; Nishida, Takashi; Yamamoto, Tetsuya

    2015-06-01

    To determine the probability of an eye with normal tension glaucoma (NTG) progressing to legal blindness under standard ophthalmic care. Patients diagnosed with NTG (n = 382) between 1985 and 2007 at Gifu University Hospital were followed for at least 5 years under standard ophthalmic care. The collected data included the best-corrected visual acuity (BCVA), intraocular pressure (IOP), and visual field status. Blindness was defined as a BCVA of blindness in one or both eyes. The mean follow-up period after diagnosis was 13.3 ± 5.4 years with a range of 5.0 to 29.1 years. At diagnosis, 18 patients (4.7%) had unilateral blindness due to glaucoma. At final examination, 34 patients had progressed to unilateral blindness and 5 to bilateral blindness. The Kaplan-Meier life table analysis estimate for unilateral blindness was 5.8 ± 1.3% at 10 years and 9.9 ± 1.9% at 20 years. Similarly, that for bilateral blindness was 0.3 ± 0.3% at 10 years and 1.4 ± 0.8% at 20 years. A Cox proportional hazard model analysis showed that a lower initial BCVA (P blindness in at least one eye. The probability of blindness in eyes with NTG is much lower than previously reported in patients with high-tension glaucoma. Nevertheless, special care should be taken to follow NTG patients, and especially those with worse BCVA and more advanced visual field loss at diagnosis.

  9. Randomized double blinded placebo controlled trial comparing diclofenac and piroxicam in management of acute renal colic and its clinical implications.

    Science.gov (United States)

    KandaSwamy, Gokul Vignesh; Dhanasekaran, Ananda Kumar; Elangovan, Aravindhan; John, Bobby; Viswaroop, Bobby; Vedanayagam, Kandasami Sangam

    2015-04-29

    To compare the efficacy of sublingual piroxicam 40 mg with intramuscular diclofenac 75 mg in treatment of acute renal colic. The secondary objective was to look for factors that can affect the severity of the pain and pain relief in acute renal colic. One hundred patients with acute renal colic were randomized into two groups. Group A (n = 50) received intramuscular diclofenac and sublingual methylcobalamin. Group B (n = 50) received sublingual piroxicam 40 mg and intramuscular distilled water. Pain severity was measured using Visual Analog Scale (VAS) and verbal and facial response scales. They were followed up for 3 h. Intramuscular injection of pentazocine 30 mg with promethazine 25 mg were used as rescue drugs. Both groups were comparable for age, sex distribution, body mass index (BMI), and pain duration before presentation. Significant pain relief was noticed in both groups. Sixteen percent in group A and 18% in group B had complete pain relief within 30 min (P = .75). Fifteen patients in group A and 13 patients in group B needed rescue drugs, 84% of group A and 76% of group B had complete pain relief at the end of 3 hours (P = .25). Decrease in pain by each scoring method was also comparable (P = .75). In multiple regression analysis, increasing age, positively affects the severity of pain and pain relief while increasing BMI negatively affect the initial pain relief. Acute renal colic seems to affect men more commonly than women, 81% of the study population were men. Patients with low initial pain score did not require any additional pain relief. Average pain duration before presenting to hospital is 260 min. Sixty percent of renal colics are due to stones below pelvic brim. The results show that sublingual piroxicam is as effective as intramuscular diclofenac. It can be easily self-administered and it overcomes the morbidity and time delay in getting intramuscular diclofenac.

  10. Comparative efficacy of continuous and pulse dose terbinafine regimes in toenail dermatophytosis: A randomized double-blind trial.

    Science.gov (United States)

    Yadav, Pravesh; Singal, Archana; Pandhi, Deepika; Das, Shukla

    2015-01-01

    Dermatophytes are the most frequently implicated agents in toenail onychomycosis and oral terbinafine has shown the best cure rates in this condition. The pharmacokinetics of terbinafine favors its efficacy in pulse dosing. To compare the efficacy of terbinafine in continuous and pulse dosing schedules in the treatment of toenail dermatophytosis. Seventy-six patients of potassium hydroxide (KOH) and culture positive dermatophyte toenail onychomycosis were randomly allocated to two treatment groups receiving either continuous terbinafine 250 mg daily for 12 weeks or 3 pulses of terbinafine (each of 500 mg daily for a week) repeated every 4 weeks. Patients were followed up at 4, 8 and 12 weeks during treatment and post-treatment at 24 weeks. At each visit, a KOH mount and culture were performed. In each patient, improvement in a target nail was assessed using a clinical score; total scores for all nails and global assessments by physician and patient were also recorded. Mycological, clinical and complete cure rates, clinical effectivity and treatment failure rates were then compared. The declines in target nail and total scores from baseline were significant at each follow-up visit in both the treatment groups. However, the inter-group difference was statistically insignificant. The same was true for global assessment indices, clinical effectivity as well as clinical, mycological, and complete cure rates. The short follow-up in our study may have led to lower cure rates being recorded. Terbinafine in pulse dosing is as effective as continuous dosing in the treatment of dermatophyte toenail onychomycosis.

  11. Efficacy and Safety of Levosulpiride Versus Haloperidol Injection in Patients With Acute Psychosis: A Randomized Double-Blind Study.

    Science.gov (United States)

    Lavania, Sagar; Praharaj, Samir Kumar; Bains, Hariender Singh; Sinha, Vishal; Kumar, Abhinav

    2016-01-01

    Injectable antipsychotics are frequently required for controlling agitation and aggression in acute psychosis. No study has examined the use of injectable levosulpiride for this indication. To compare the efficacy and safety of injectable levosulpiride and haloperidol in patients with acute psychosis. This was a randomized, double-blind, parallel-group study in which 60 drug-naive patients having acute psychosis were randomly assigned to receive either intramuscular haloperidol (10-20 mg/d) or levosulpiride (25-50 mg/d) for 5 days. All patients were rated on Brief Psychiatric Rating Scale (BPRS), Overt Agitation Severity Scale (OASS), Overt Aggression Scale-Modified (OAS-M) scores, Simpson Angus Scale (SAS), and Barnes Akathisia Rating Scale (BARS). Repeated-measures ANOVA for BPRS scores showed significant effect of time (P haloperidol group as shown by group × time interaction (P = 0.076). Repeated-measures ANOVA for OASS showed significant effect of time (P haloperidol group as shown by group × time interaction (P = 0.032). Lorazepam requirement was much lower in haloperidol group as compared with those receiving levosulpiride (P = 0.022). Higher rates of akathisia and extrapyramidal symptoms were noted in the haloperidol group. Haloperidol was more effective than levosulpiride injection for psychotic symptoms, aggression, and severity of agitation in acute psychosis, but extrapyramidal adverse effects were less frequent with levosulpiride as compared with those receiving haloperidol.

  12. Comparative evaluation of hemodynamic, vasoconstrictive, and SpO2variability during different stages of periodontal surgery performed using 0.5% ropivacaine or 2% lignocaine HCl (1:80,000 adrenaline local anesthesia: A randomized, double-blind, split-mouth pilot study

    Directory of Open Access Journals (Sweden)

    Ashank Mishra

    2018-01-01

    Full Text Available Aim: The aim of this study is to compare anesthetic, hemodynamic, vasoconstrictive, and SpO2variability of 0.5% ropivacaine to the “gold standard” lignocaine (2% with epinephrine (1:80,000 during periodontal surgery. Materials and Methods: A total of 20 systemically healthy controls meeting the inclusion criteria were selected from the Outpatient Department of Sri Sai College of Dental Surgery. Preoperatively, all participants were infiltrated with 0.5 ml of 0.5% ropivacaine intradermally as test solution to record any allergic reaction. Open flap debridement was performed using local anesthesia containing 2% lignocaine hydrochloride with 1:80,000 epinephrine or 0.5% ropivacaine. Recordings were made of the time of onset, duration of action, the intensity, and depth of anesthesia and various hemodynamic changes throughout the surgical procedure. In addition, blood loss volume and postoperative pain were also assessed. Results: Ropivacaine showed statistically longer duration of action (mean±SD =5.3±0.71 hrs than lignocaine with epinephrine (mean=2.14±0.98 hrs. Blood loss during flap surgery was comparatively less when performed under ropivacaine. No statistical differences were observed in systolic BP, diastolic BP, SpO2 and heart rate during different stages of periodontal surgery between either of the local anesthetic agents Conclusion: Ropivacaine demonstrates comparable efficacy as lignocaine with added advantage of longer duration of action and superior postoperative pain control. No adverse events from this newer anesthetic were noted, and hence, it can be used safely as a viable local anesthetic for periodontal surgical procedures.

  13. Sad Facial Expressions Increase Choice Blindness.

    Science.gov (United States)

    Wang, Yajie; Zhao, Song; Zhang, Zhijie; Feng, Wenfeng

    2017-01-01

    Previous studies have discovered a fascinating phenomenon known as choice blindness-individuals fail to detect mismatches between the face they choose and the face replaced by the experimenter. Although previous studies have reported a couple of factors that can modulate the magnitude of choice blindness, the potential effect of facial expression on choice blindness has not yet been explored. Using faces with sad and neutral expressions (Experiment 1) and faces with happy and neutral expressions (Experiment 2) in the classic choice blindness paradigm, the present study investigated the effects of facial expressions on choice blindness. The results showed that the detection rate was significantly lower on sad faces than neutral faces, whereas no significant difference was observed between happy faces and neutral faces. The exploratory analysis of verbal reports found that participants who reported less facial features for sad (as compared to neutral) expressions also tended to show a lower detection rate of sad (as compared to neutral) faces. These findings indicated that sad facial expressions increased choice blindness, which might have resulted from inhibition of further processing of the detailed facial features by the less attractive sad expressions (as compared to neutral expressions).

  14. The efficacy of the semi-blind approach of transversus abdominis plane block on postoperative analgesia in patients undergoing inguinal hernia repair: a prospective randomized double-blind study

    Directory of Open Access Journals (Sweden)

    Salman AE

    2013-01-01

    Full Text Available A Ebru Salman,1 Fahri Yetisir,2 Banu Yürekli,3 Mustafa Aksoy,1 Murat Yildirim,2 Mehmet Kiliç21Anesthesiology and Reanimation Department, 2General Surgery Department, Atatürk Research and Training Hospital, Ankara, Turkey; 3Endocrinology Department, Bozyaka Research and Training Hospital, Izmir, TurkeyPurpose: In this prospective, randomized, double-blind study, our aim was to compare the analgesic efficacy of the semi-blind approach of transversus abdominis plane (TAP block with a placebo block in patients undergoing unilateral inguinal hernia repair.Methods: After receiving hospital ethical committee approval and informed patient consents, American Society of Anesthesiologists (ASA I–III patients aged 18–80 were enrolled in the study. Standard anesthesia monitoring was applied to all patients. After premedication, spinal anesthesia was administered to all patients with 3.5 mL heavy bupivacaine at the L3-L4 subarachnoid space. Patients were randomly allocated into 2 groups. Group I (n = 32 received a placebo block with 20 mL saline, Group II (n = 32 received semi-blind TAP block with 0.25% bupivacaine in 20 mL with a blunt regional anesthesia needle into the neurofascial plane via the lumbar triangle of Petit near the midaxillary line before fascial closure. At the end of the operation, intravenous (IV dexketoprofen was given to all patients. The verbal analog scale (VAS was recorded at 2, 4, 6, 12, and 24 hours postoperatively. Paracetamol IV was given to patients if their VAS score > 3. A rescue analgesic of 0.05 mg/kg morphine IV was applied if VAS > 3. Total analgesic consumption and morphine requirement in 24 hours were recorded.Results: TAP block reduced VAS scores at all postoperative time points (P < 0.001. Postoperative analgesic and morphine requirement in 24 hours was significantly lower in group II (P < 0.01.Conclusion: Semi-blind TAP block provided effective analgesia, reducing total 24-hour postoperative analgesic

  15. Randomized Controlled Double-blind Trial Comparing Haloperidol Combined With Conventional Therapy to Conventional Therapy Alone in Patients With Symptomatic Gastroparesis.

    Science.gov (United States)

    Roldan, Carlos J; Chambers, Kimberly A; Paniagua, Linda; Patel, Sonali; Cardenas-Turanzas, Marylou; Chathampally, Yashwant

    2017-11-01

    Gastroparesis is a debilitating condition that causes nausea, vomiting, and abdominal pain. Management includes analgesics and antiemetics, but symptoms are often refractory. Haloperidol has been utilized in the palliative care setting for similar symptoms. The study objective was to determine whether haloperidol as an adjunct to conventional therapy would improve symptoms in gastroparesis patients presenting to the emergency department (ED). This was a randomized, double-blind, placebo-controlled trial of adult ED patients with acute exacerbation of previously diagnosed gastroparesis. The treatment group received 5 mg of haloperidol plus conventional therapy (determined by the treating physician). The control group received a placebo plus conventional therapy. The severity of each subject's abdominal pain and nausea were assessed before intervention and every 15 minutes thereafter for 1 hour using a 10-point scale for pain and a 5-point scale for nausea. Primary outcomes were decreased pain and nausea 1 hour after treatment. Of the 33 study patients, 15 were randomized to receive haloperidol. Before treatment, the mean intensity of pain was 8.5 in the haloperidol group and 8.28 in the placebo group; mean pretreatment nausea scores were 4.53 and 4.11, respectively. One hour after therapy, the mean pain and nausea scores in the haloperidol group were 3.13 and 1.83 compared to 7.17 and 3.39 in the placebo group. The reduction in mean pain intensity therapy was 5.37 in the haloperidol group (p ≤ 0.001) compared to 1.11 in the placebo group (p = 0.11). The reduction in mean nausea score was 2.70 in the haloperidol group (p ≤ 0.001) and 0.72 in the placebo group (p = 0.05). Therefore, the reductions in symptom scores were statistically significant in the haloperidol group but not in the placebo group. No adverse events were reported. Haloperidol as an adjunctive therapy is superior to placebo for acute gastroparesis symptoms. © 2017 by the Society for Academic

  16. Does Combination Therapy with Tamsulosin and Tolterodine Improve Ureteral Stent Discomfort Compared with Tamsulosin Alone? A Double-Blind, Randomized, Controlled Trial.

    Science.gov (United States)

    Sivalingam, Sri; Streeper, Necole M; Sehgal, Priyanka D; Sninsky, Brian C; Best, Sara L; Nakada, Stephen Y

    2016-02-01

    Ureteral stent discomfort is a significant postoperative problem for many patients. Despite the use of narcotics and α-blockers patients often experience bothersome lower urinary tract symptoms and pain, which impair daily activities. We compared combination therapy with an α-blocker and an anticholinergic to monotherapy with an α-blocker. A double-blind, randomized, controlled trial was performed from December 2012 to April 2014. A total of 80 patients were randomized, including 44 to the combination group (tamsulosin 0.4 mg and tolterodine early release 4 mg) and 36 to the monotherapy group (tamsulosin 0.4 mg and placebo). Patients with preexisting ureteral stent placement or current anticholinergic therapy were excluded from study. Patients completed USSQ (Urinary Stent Symptom Questionnaire) before stent placement on the day of surgery, the day after stent placement, the morning of stent removal and the day after stent removal. The questionnaire included questions regarding urinary symptoms, general health, body pain, and work and sexual history. A total of 80 patients (40 males and 40 females) were studied. Mean age was 51.5 vs 51.3 years (p = 0.95) and mean body mass index was 33.6 vs 31.9 kg/m(2) (p = 0.44) in monotherapy group 1 vs combination therapy group 2. Between the 2 groups there was no significant difference in urinary symptoms, body pain and activities of daily living from baseline to just before stent removal (p = 0.95, 0.40 and 0.95, respectively). Although there was no difference between the groups, both showed improvement in urinary symptoms from the time of initial stent insertion to just prior to stent removal (difference -0.50 for combination therapy and -0.40 for monotherapy). The mean stent indwelling time of 9.6 and 8.7 days in the combination and monotherapy groups, respectively, did not differ (p = 0.67). On ANOVA it had no significant impact on results (p = 0.64). Combination therapy with tamsulosin and tolterodine does not

  17. Expanding Our Vision of Museum Education and Perception: An Analysis of Three Case Studies of Independent Blind Arts Learners

    Science.gov (United States)

    Hayhoe, Simon

    2013-01-01

    In this study, Simon Hayhoe investigates the experiences of blind museum visitors in the context of the relationships between the artworks they learned about in museums, those they experienced when younger, and the social, cultural, and emotional influences of their museum experiences. The three case studies he presents support his hypothesis…

  18. Survey of low vision among students attending schools for the blind in Nigeria: a descriptive and interventional study.

    Science.gov (United States)

    Mosuro, Adedamola L; Ajaiyeoba, Ayotunde I; Bekibele, Charles O; Eniola, Michael S; Adedokun, Babatunde A

    2012-10-01

    The aim of this study is to determine the prevalence of low vision among students attending all the schools for the blind in Oyo State, Nigeria. The study set out to determine the proportion of students with low vision/severe visual impairment after best correction, to determine the causes of the low vision, to document the associated pathologies, to determine the types of treatment and visual aid devices required, and to provide the visual aids needed to the students in the schools. All schools students for the blind in Oyo State were evaluated between August 2007 and January 2008. All the students underwent a thorough ophthalmic examination that included measurement of visual acuity, retinoscopy and subjective refraction, tests for visual aids where indicated, and a structured questionnaire was administered. A total of 86 students were included in the study and the mean age was 19.4 ± 8.19 years. Twenty six (30%) were under 16 years of age. The most common cause of blindness was bilateral measles keratopathy/vitamin A deficiency (VAD) in 25 students (29.1%). The most common site affected was the cornea in 25 students (29.1%), the lens in 23 (26.7%), and the retina/optic nerve in 16 (18.6%). Preventable blindness was mainly from measles keratopathy/VAD (29.1%). Eleven students benefited from refraction and correction with visual aids; two having severe visual impairment (SVI), and nine having visual impairment (VI) after correction. The prevalence of low vision in the schools for the blind in Oyo State is 2.3%, while the prevalence of visual impairment is 10.5%. These results suggest that preventable and treatable ocular conditions are the source of significant childhood blindness in Oyo State.

  19. Vitamin B6 versus mianserin and placebo in acute neuroleptic-induced akathisia: a randomized, double-blind, controlled study.

    Science.gov (United States)

    Miodownik, Chanoch; Lerner, Vladimir; Statsenko, Nikolay; Dwolatzky, Tzvi; Nemets, Boris; Berzak, Elina; Bergman, Joseph

    2006-01-01

    Treatment strategies against acute neuroleptic-induced akathisia (NIA) include anticholinergic (antimuscarinic) agents, dopamine agonists, GABAergic agents, beta-blockers, benzodiazepines, and serotonin antagonists. However, many patients who have acute akathisia fail to respond. In previous studies, mianserin and vitamin B6 were found to be effective in the treatment of acute akathisia. The purpose of this study was to compare the efficacy of B(6), mianserin and placebo in the treatment of acute NIA. Sixty schizophrenia and schizoaffective inpatients who have NIA were randomly divided to receive vitamin B(6) 1,200 mg/d, mianserin 15 mg/d, or placebo for 5 days, in a double-blind design. The Barnes Akathisia Rating Scale, Brief Psychiatric Rating Scale, and Clinical Global Impression were used to assess the severity of NIA and psychotic symptoms. The assessment was made at baseline and daily for the duration of the study. Compared with the placebo group, the vitamin B(6)-treated and mianserin-treated patients showed a significant improvement in the subjective (P vitamin B(6) group (13/23, 56%) as well as in the mianserin groups (13/20, 65%), and in only one patient in the placebo group (1/17, 6%; P vitamin B(6) and mianserin suggests that the pathophysiology of acute NIA is heterogeneous with the various subtypes of acute NIA responding differently to the various pharmacological approaches.

  20. Design challenges in a double-blinded RCT study of music therapy for people suffering from szhizophrenia with negative symptoms

    DEFF Research Database (Denmark)

    Pedersen, Inge Nygaard

    2016-01-01

    . The study includes 120 participants. Participants in the experimental group become 25 hours of individual music therapy by specific trained music therapists working from a manual, wheras the control Group become 25 hours of being together with a care persone (trained by a music therapist) for music...... listening from a selected playlist. Ethical refelctions around the design will be presented, and the possibilities of keeping the examination process blinded or not blinded to the participants with be shared. As this examination is currently running, the focus will be on the Development of abd application...

  1. Enhanced chemosensory detection of negative emotions in congenital blindness

    DEFF Research Database (Denmark)

    Iversen, Katrine D.; Ptito, Maurice; Møller, Per

    2015-01-01

    blind and normal sighted individuals in their ability to discriminate and identify emotions from body odours. A group of 14 congenitally blind and 14 age- and sex-matched sighted control subjects participated in the study. We compared participants' abilities to detect and identify by smelling sweat from...

  2. A double blind randomized clinical trial comparing lingualized and fully bilateral balanced posterior occlusion for conventional complete dentures.

    Science.gov (United States)

    Kawai, Yasuhiko; Ikeguchi, Nobuyuki; Suzuki, Asako; Kuwashima, Azusa; Sakamoto, Ryuji; Matsumaru, Yuichi; Kimoto, Suguru; Iijima, Morio; Feine, Jocelyne Sylvia

    2017-04-01

    A lingualized occlusion (LO) for complete dentures reduces lateral inferences and occlusal force contacts and direction; thus, LO is theorized to be more suitable for patients with compromised ridges than fully bilateral balanced articulation (FBBA). However, no studies have yet provided evidence to support LO in edentate patients with compromised alveolar ridges. The purpose of this study was to compare LO and FBBA in edentulous individuals with compromised ridges. Sixty edentulous individuals were randomly allocated into groups and received dentures with either LO or FBBA. Following delivery, several denture-related satisfaction variables were measured using 100mm visual analogue scales; oral health-related quality of life (OHRQoL) was also assessed using the Oral Health Impact Profile (OHIP). Sub-group analyses of the effect of moderate and severe mandibular bone loss were also carried out. No significant differences were detected between LO and FBBA with the primary outcome. At 6 months, participants with severely atrophied mandibles and FBBA rated their satisfaction with retention of mandibular dentures significantly lower than those with LO (median LO: 86, FBBA: 58.5, p=0.03). They also had significantly lower OHRQoL for the domain of Pain (median LO: 4, FBBA: 5, p=0.02). General satisfaction and total OHIP scores significantly improved between baseline and 6 months only for the LO subjects with severely atrophied mandibles (satisfaction: p=0.003, OHIP total score: p=0.0007). The results indicate that the LO occlusal scheme with hard resin artificial teeth is more efficient for patients with severely resorbed mandibular ridges. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  3. Maintenance of Blinding in Clinical Trials and the Implications for Studying Analgesia Using Cannabinoids

    Science.gov (United States)

    Wilsey, Barth; Deutsch, Reena; Marcotte, Thomas D.

    2016-01-01

    Abstract The design of analgesic clinical trials invariably involves a comparison between placebo and active study medication. An assumption is made that treatment effects can be approximated by subtracting the response to placebo from that attained with the use of active study medication. However, the psychoactivity of cannabinoids may unmask their presence and lead to an expectation and/or conditioning of pain relief. For example, study participants biased toward the belief that cannabis is beneficial for their condition might be more inclined to report positive effects if they were to accurately identify the active treatment because of its psychoactivity. This may lead to incorrect assumptions regarding the efficacy of a cannabinoid. Methodologies designed to counteract unmasking need to be implemented in the design phase of a study. During the clinical trial, it is also important to query participants as to which treatment they believe they have received. Blinding can be considered to be preserved when the accuracy of treatment guesses is not considerably different than random guessing, which is estimated to be correct 50% of the time. After a study has been completed, the use of statistical methodologies such as regression and mediation analysis are worthy of consideration to see whether psychoactive effects biased the results. PMID:28861490

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

    Science.gov (United States)

    Kim, Kyung-Ah; Yim, Jung-Eun

    2015-09-01

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

  5. The sensory construction of dreams and nightmare frequency in congenitally blind and late blind individuals.

    Science.gov (United States)

    Meaidi, Amani; Jennum, Poul; Ptito, Maurice; Kupers, Ron

    2014-05-01

    We aimed to assess dream content in groups of congenitally blind (CB), late blind (LB), and age- and sex-matched sighted control (SC) participants. We conducted an observational study of 11 CB, 14 LB, and 25 SC participants and collected dream reports over a 4-week period. Every morning participants filled in a questionnaire related to the sensory construction of the dream, its emotional and thematic content, and the possible occurrence of nightmares. We also assessed participants' ability of visual imagery during waking cognition, sleep quality, and depression and anxiety levels. All blind participants had fewer visual dream impressions compared to SC participants. In LB participants, duration of blindness was negatively correlated with duration, clarity, and color content of visual dream impressions. CB participants reported more auditory, tactile, gustatory, and olfactory dream components compared to SC participants. In contrast, LB participants only reported more tactile dream impressions. Blind and SC participants did not differ with respect to emotional and thematic dream content. However, CB participants reported more aggressive interactions and more nightmares compared to the other two groups. Our data show that blindness considerably alters the sensory composition of dreams and that onset and duration of blindness plays an important role. The increased occurrence of nightmares in CB participants may be related to a higher number of threatening experiences in daily life in this group. Copyright © 2014 Elsevier B.V. All rights reserved.

  6. Better than sham? A double-blind placebo-controlled neurofeedback study in primary insomnia.

    Science.gov (United States)

    Schabus, Manuel; Griessenberger, Hermann; Gnjezda, Maria-Teresa; Heib, Dominik P J; Wislowska, Malgorzata; Hoedlmoser, Kerstin

    2017-04-01

    See Thibault et al. (doi:10.1093/awx033) for a scientific commentary on this article.Neurofeedback training builds upon the simple concept of instrumental conditioning, i.e. behaviour that is rewarded is more likely to reoccur, an effect Thorndike referred to as the 'law of effect'. In the case of neurofeedback, information about specific electroencephalographic activity is fed back to the participant who is rewarded whenever the desired electroencephalography pattern is generated. If some kind of hyperarousal needs to be addressed, the neurofeedback community considers sensorimotor rhythm neurofeedback as the gold standard. Earlier treatment approaches using sensorimotor-rhythm neurofeedback indicated that training to increase 12-15 Hz sensorimotor rhythm over the sensorimotor cortex during wakefulness could reduce attention-deficit/hyperactivity disorder and epilepsy symptoms and even improve sleep quality by enhancing sleep spindle activity (lying in the same frequency range). In the present study we sought to critically test whether earlier findings on the positive effect of sensorimotor rhythm neurofeedback on sleep quality and memory could also be replicated in a double-blind placebo-controlled study on 25 patients with insomnia. Patients spent nine polysomnography nights and 12 sessions of neurofeedback and 12 sessions of placebo-feedback training (sham) in our laboratory. Crucially, we found both neurofeedback and placebo feedback to be equally effective as reflected in subjective measures of sleep complaints suggesting that the observed improvements were due to unspecific factors such as experiencing trust and receiving care and empathy from experimenters. In addition, these improvements were not reflected in objective electroencephalographic-derived measures of sleep quality. Furthermore, objective electroencephalographic measures that potentially reflected mechanisms underlying the efficacy of neurofeedback such as spectral electroencephalographic

  7. Increasing work-place healthiness with the probiotic Lactobacillus reuteri: A randomised, double-blind placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Stan Vlaicu

    2005-11-01

    Full Text Available Abstract Background Short term illnesses, usually caused by respiratory or gastrointestinal diseases are disruptive to productivity and there is relatively little focus on preventative measures. This study examined the effect of the probiotic Lactobacillus reuteri protectis (ATCC55730 on its ability to improve work-place healthiness by reducing short term sick-leave caused by respiratory or gastrointestinal infections. Methods 262 employees at TetraPak in Sweden (day-workers and three-shift-workers that were healthy at study start were randomised in a double-blind fashion to receive either a daily dose of 108 Colony Forming Units of L. reuteri or placebo for 80 days. The study products were administered with a drinking straw. 181 subjects complied with the study protocol, 94 were randomised to receive L. reuteri and 87 received placebo. Results In the placebo group 26.4% reported sick-leave for the defined causes during the study as compared with 10.6% in the L. reuteri group (p L. reuteri group (p L. reuteri group(p

  8. COMPARATIVE STUDY ON SPECIFIC AND EARLY DETECTION ...

    African Journals Online (AJOL)

    The objective of this study was to compare the sensitivity and specificity of smear and culture methods with rapid serological EIA myco kits manufactured by Omega diagnostics, for the early detection of Mycobacterium tuberculosis (MTB) complex. Sera from various categories of smear and culture results were compared ...

  9. Complex antioxidants in a randomized single-blinded study of memory in seniors.

    Science.gov (United States)

    Summers, William K; Martin, Roy L; Liu, Yimeng; Peña, Bernice; Marsh, Gary M

    2018-04-01

    Oxidative injury to the brain and aging are theoretical co-causes of Alzheimer's Disease (AD). Amyloid plaques and tangles are then secondary phenomenon. The preclinical state would then be 'normal' elderly. A potent complex antioxidant (antiOx) was tested against a popular one-a-day multivitamin (mV) in a randomized single blind design in 'normal' senior subjects over 6 months. Memory testing was done at baseline, 1, 3, and 6 months. The generalized estimating equation (GEE) approach was used to compare the change score of NLT 100 and 20 WR between two groups over time. Analysis of the antiOx group (30 subjects) demonstrated significant improvement in declarative memory (change score for NLT 100 at month 6 = 6.36 p working memory (change score for 20 WR at month 6 = 3.23, p < 0.0001). A change-score analysis over 6 months suggests possible neurogenesis in the antiOx group. The mV group (33 subjects) had a change score of the NLT 100 and 20WR on the sixth month of 2.20 and 0.32 (p = 0.07, 0.35). A complex antioxidant blend, sold as an over-the-counter (OTC) supplement, can improve memory in elder subjects. Antioxidants may be beneficial in AD and other neurodegerative diseases.

  10. Evaluation of the GARD assay in a blind Cosmetics Europe study.

    Science.gov (United States)

    Johansson, Henrik; Gradin, Robin; Forreryd, Andy; Agemark, Maria; Zeller, Kathrin; Johansson, Angelica; Larne, Olivia; van Vliet, Erwin; Borrebaeck, Carl; Lindstedt, Malin

    2017-01-01

    Chemical hypersensitivity is an immunological response towards foreign substances, commonly referred to as sensitizers, which gives rise primarily to the clinical symptoms known as allergic contact dermatitis. For the purpose of mitigating risks associated with consumer products, chemicals are screened for sensitizing effects. Historically, such predictive screenings have been performed using animal models. However, due to industrial and regulatory demand, animal models for the purpose of sensitization assessment are being replaced by non-animal testing methods, a global trend that is spreading across industries and market segments. To meet this demand, the Genomic Allergen Rapid Detection (GARD) assay was developed. GARD is a novel, cell-based assay that utilizes the innate recognition of xenobiotic substances by dendritic cells, as measured by a multivariate readout of genomic biomarkers. Following cellular stimulation, chemicals are classified as sensitizers or non-sensitizers based on induced transcriptional profiles. Recently, a number of non-animal methods were comparatively evaluated by Cosmetics Europe, using a coherent and blinded test panel of reference chemicals with human and local lymph node assay data, comprising a wide range of sensitizers and non-sensitizers. The outcome of the GARD assay is presented in this paper. It was demonstrated that GARD is a highly functional assay with a predictive performance of 83% in this Cosmetics Europe dataset. The average accumulated predictive accuracy of GARD across independent datasets was 86% for skin sensitization hazard.

  11. A Case Study of Tack Tiles[R] Literacy Instruction for a Student with Multiple Disabilities Including Congenital Blindness

    Science.gov (United States)

    Klenk, Jessicia A.; Pufpaff, Lisa A.

    2011-01-01

    Research on literacy instruction for students with multiple disabilities is limited. Empirical research on braille instruction for students with multiple disabilities that include congenital blindness is virtually nonexistent. This case study offers initial insight into possible methods of early braille literacy instruction for a student with…

  12. Charles Miller Fisher: the 65th anniversary of the publication of his groundbreaking study "Transient Monocular Blindness Associated with Hemiplegia".

    Science.gov (United States)

    Araújo, Tiago Fernando Souza de; Lange, Marcos; Zétola, Viviane H; Massaro, Ayrton; Teive, Hélio A G

    2017-10-01

    Charles Miller Fisher is considered the father of modern vascular neurology and one of the giants of neurology in the 20th century. This historical review emphasizes Prof. Fisher's magnificent contribution to vascular neurology and celebrates the 65th anniversary of the publication of his groundbreaking study, "Transient Monocular Blindness Associated with Hemiplegia."

  13. Evaluation Study of Short-Term Programs at a Residential School for Students Who Are Blind and Visually Impaired

    Science.gov (United States)

    Pogrund, Rona L.; Darst, Shannon; Boland, Teryl

    2013-01-01

    Introduction: The results of a 2009-2010 program evaluation study that examined parents, teachers of students with visual impairments, administrators, and students regarding overall satisfaction with and effectiveness of the short-term programs at a residential school for students who are blind and visually impaired are described. The findings are…

  14. A double-blind placebo-controlled study of controlled release fluvoxamine for the treatment of generalized social anxiety disorder

    NARCIS (Netherlands)

    Westenberg, HGM; Stein, DJ; Yang, HC; Li, D; Barbato, LM

    This was a randomized double-blind placebo-controlled multicenter study to assess the efficacy, safety, and tolerability of fluvoxamine in a controlled release (CR) formulation for treatment of generalized social anxiety disorder (GSAD). A total of 300 subjects with GSAD were randomly assigned to

  15. Bright light in elderly subjects with nonseasonal major depressive disorder: a double blind randomised clinical trial using early morning bright blue light comparing dim red light treatment

    Directory of Open Access Journals (Sweden)

    van Someren Eus JW

    2008-07-01

    Full Text Available Abstract Background Depression frequently occurs in the elderly. Its cause is largely unknown, but several studies point to disturbances of biological rhythmicity. In both normal aging, and depression, the functioning of the suprachiasmatic nucleus (SCN is impaired, as evidenced by an increased prevalence of day-night rhythm perturbations, such as sleeping disorders. Moreover, the inhibitory SCN neurons on the hypothalamus-pituitary adrenocortical axis (HPA-axis have decreased activity and HPA-activity is enhanced, when compared to non-depressed elderly. Using bright light therapy (BLT the SCN can be stimulated. In addition, the beneficial effects of BLT on seasonal depression are well accepted. BLT is a potentially safe, nonexpensive and well accepted treatment option. But the current literature on BLT for depression is inconclusive. Methods/Design This study aims to show whether BLT can reduce non-seasonal major depression in elderly patients. Randomized double blind placebo controlled trial in 126 subjects of 60 years and older with a diagnosis of major depressive disorder (MDD, DSM-IV/SCID-I. Subjects are recruited through referrals of psychiatric outpatient clinics and from case finding from databases of general practitioners and old-people homes in the Amsterdam region. After inclusion subjects are randomly allocated to the active (bright blue light vs. placebo (dim red light condition using two Philips Bright Light Energy boxes type HF 3304 per subject, from which the light bulbs have been covered with bright blue- or dim red light- permitting filters. Patients will be stratified by use of antidepressants. Prior to treatment a one-week period without light treatment will be used. At three time points several endocrinological, psychophysiological, psychometrically, neuropsychological measures are performed: just before the start of light therapy, after completion of three weeks therapy period, and three weeks thereafter. Discussion If BLT

  16. 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

  17. Efficacy of the natural antioxidant astaxanthin in the treatment of functional dyspepsia in patients with or without Helicobacter pylori infection: a prospective, randomized, double blind, and placebo-controlled study5

    DEFF Research Database (Denmark)

    Kupcinskas, L.; Lafolie, P.; Lignell, A.

    2008-01-01

    OBJECTIVES: The aim of this study was to evaluate the efficacy of the natural antioxidant astaxanthin in functional dyspepsia in different doses and compared with placebo. DESIGN: The study was a controlled, prospective, randomized, and double blind trial. PARTICIPANTS: Patients with functional d...

  18. Effects of Herbal vigRX on Premature Ejaculation: A randomized, double-blind study

    Directory of Open Access Journals (Sweden)

    Z Ghafuri

    2010-05-01

    Full Text Available Objective :   "nWe conducted a double-blind, placebo-controlled study todetermine the efficacy of an herbal sexual supplement (vigRX on premature ejaculation (PE. Method: "nA randomized double blind study was conducted on a fixed dose of herbal vigRX at Roozbeh Psychiatry Hospital, Tehran University of Medical Sciences. The sample consisted of 85 married patients diagnosed withprimary PE according to Diagnostic and Statistical Manual of Mental Disorders. Each patient underwent diagnostic evaluation by one trained psychiatrist, using Structured Clinical Interview for DSM-IV-TR. Each patient was evaluated by researchers to exclude the organic sexual dysfunctions. The patients were randomly assigned in to two groups: group 1 consisting of 42 patients receiving placebo, and group 2 consisting of 43 patients receiving 540 mg herbal vigRX for a 4-week treatment course. The effects of the drug on the ejaculatory function in each group were assessed by the intravaginal ejaculation latency time (IELT, and the Chinese Index of Premature Ejaculation (CIPE before and at the end of the treatment course. Statistical analysis was performed using SPSS software (15th version.      Results: "nThe mean IELT increased 22.4 and 32.0 seconds in the placebo and the vigRX group respectively after the treatment course. The mean IELT differences between the two groups was not significant. The mean CIPE score increased 2.40 and 4.37 in the placebo and the vigRX group respectively .The mean CIPE score differences between the two groups was not significant.No side effect was reported by the subjects in neither groups during the treatment course. "nConclusion: Although the improvement in IELT and CIPE scores in the herbal vigRX group was more than the placebo group, this difference was not statistically significant. The increasing of IELT and CIPE score in the placebo group may be due to the placebo effects. Further studies with higher vigRX doses, greater sample size

  19. A randomized, blinded study of the impact of intercessory prayer on spiritual well-being in patients with cancer.

    Science.gov (United States)

    Olver, Ian N; Dutney, Andrew

    2012-01-01

    Cochrane reviews have analyzed multiple studies on intercessory prayer that treatment teams had added to health interventions; however, the reviewers could draw no conclusions about the efficacy of prayer because the studies showed either positive or no effects and used different endpoints and methodologies. The study intended to determine whether researchers could measure the impact of intercessory prayer on spiritual well-being. The research team conducted a randomized blinded trial of intercessory prayer added to normal cancer treatment with participants agreeing to complete quality of life (QOL) and spiritual well-being scales at baseline and 6 months later. The research team had shown previously that spiritual well-being is an important, unique domain in the assessment of QOL. Participants remained blinded to the randomization. Based on a previous study, the research team determined that the study required a sample of 1000 participants to detect small differences (P = .05, 2-tailed, 80% power). SETTING The research team performed this research at the Royal Adelaide Hospital Cancer Centre, South Australia, Australia. Participants were patients at the cancer center between June 2003 and May 2008. Of 999 participants with mixed diagnoses who completed the baseline questionnaires, 66.6% provided follow-up. The average age was 61 years, and most participants were married/de facto (living with partners), were Australians or New Zealanders living in Australia, and were Christian. Intervention The research team asked an external group offering Christian intercessory prayer to add the study's participants to their usual prayer lists. They received details about the participants, but this information was not sufficient to identify them. Outcome Measures The research team used the Functional Assessment of Chronic Illness Therapy-Spiritual Well-being questionnaire to assess spiritual wellbeing and QOL. Results The intervention group showed significantly greater

  20. A single center, pilot, double-blinded, randomized, comparative, prospective clinical study to evaluate improvements in the structure and function of facial skin with tazarotene 0.1% cream alone and in combination with GliSODin® Skin Nutrients Advanced A

    Directory of Open Access Journals (Sweden)

    Goldberg LD

    2014-05-01

    Full Text Available Lawrence D Goldberg, Corina CryslerShaft Medical San Diego, San Diego, CA, USABackground: Superoxide dismutase (SOD reduces the reactive oxygen species formation associated with oxidative stress. An imbalance between free radicals and antioxidants can lead to accelerated aging. GliSODin® Skin Nutrients Advanced Anti-Aging Formula (GAAF is an SOD-containing dietary nutricosmetic formulated with other nutraceuticals that promote improvements in the structure and function of the skin, including hydration, elasticity, structural integrity, and photoaging caused by oxidative stress. Tazarotene cream 0.1% (TAZ is a United States Food and Drug Administration-approved drug indicated for use in the mitigation of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines when taken in conjunction with a comprehensive skin care and sun avoidance program.Objective: To determine if the antioxidant, anti-aging, hydrating and skin-rejuvenating properties of GAAF complement the retinoic actions of TAZ to improve the structure and function of facial skin.Method: A 90-day comparative study of ten subjects with facial photodamage; daily topical application of TAZ was used in combination with three capsules of GAAF (780 mg each or placebo orally, with food, per the randomization allocation.Results: After 90 days of treatment, TAZ alone and in combination with GAAF improved fine wrinkles (↓1.2 versus 2.0, mottled hyperpigmentation (↓2.2 versus 2.8 and overall photodamage (↓1.0 versus 1.8, as well as patient-reported response to treatment (↓2.0 versus 1.6. At week 12, TAZ/GAAF combination treatment (Group A versus TAZ treatment alone (Group C was of significant clinical benefit, with respect to fine wrinkling (14.7%/41.7%, overall photodamage (15.6%/53.0%, skin moisture (19.1%/103.2%, skin elasticity (12.8%/87.7%, and response to treatment (8.8%/21.4%.Conclusion: The study suggests GAAF in combination with TAZ is safe and

  1. Synthetic food colourings and 'hyperactivity': a double-blind crossover study.

    Science.gov (United States)

    Rowe, K S

    1988-04-01

    Of 220 children referred for suspected 'hyperactivity', 55 were subjected to a 6 week trial of the Feingold diet. Forty (72.7%) demonstrated improved behaviour and 26 (47.3%) remained improved following liberalization of the diet over a period of 3-6 months. The parents of 14 children claimed that a particular cluster of behaviours was associated with the ingestion of foods containing synthetic colourings. A double-blind crossover study, employing a single-subject repeated measures design was conducted, using eight of these children. Subjects were maintained on a diet free from synthetic additives and were challenged daily for 18 weeks with either placebo (during lead-in and washout periods) or 50 mg of either tartrazine or carmoisine, each for 2 separate weeks. Two significant reactors were identified whose behavioural pattern featured extreme irritability, restlessness and sleep disturbance. One of the reactors did not have inattention as a feature. The findings raise the issue of whether the strict criteria for inclusion in studies concerned with 'hyperactivity' based on 'attention deficit disorder' may miss children who indicate behavioural changes associated with the ingestion of food colourings. Moreover, for further studies, the need to construct a behavioural rating instrument specifically validated for dye challenge is suggested.

  2. Effect of Saccharomyces boulardii in dog with chronic enteropathies: double-blinded, placebo-controlled study.

    Science.gov (United States)

    D'Angelo, Simona; Fracassi, Federico; Bresciani, Francesca; Galuppi, Roberta; Diana, Alessia; Linta, Nikolina; Bettini, Giuliano; Morini, Maria; Pietra, Marco

    2018-03-03

    Saccharomyces boulardii is used to treat acute and chronic enteropathies in humans, but to date, no studies have evaluated the use of this yeast in dogs. The current study, a prospective non-randomised, double-blinded, placebo-controlled study, evaluated the effects of S boulardii in healthy dogs and dogs with chronic enteropathies (CE). Four healthy dogs and 20 dogs with CE were included. In healthy dogs, S boulardii was administered for 10 days. Possible short-term adverse effects were recorded, and quantitative stool cultures for yeasts were performed. In dogs with CE, S boulardii or a placebo was administered in addition to standard treatment protocols. Canine Chronic Enteropathy Clinical Activity Index, abdominal ultrasonography, gastroenteroscopy and histology were performed at the time of diagnosis and after 60 days of treatment. In healthy dogs, S boulardii reached a steady state in five days and was completely eliminated on day 4 after administration. No short-term side effects were seen. Clinical activity index, stool frequency, stool consistency and body condition score improved significantly in dogs with CE receiving S boulardii versus the placebo. In conclusion, S boulardii can be safely used in dogs with CE and seems to achieve better control of clinical signs than standard therapy alone. © British Veterinary Association (unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  3. Tactile Acuity in the Blind: A Closer Look Reveals Superiority over the Sighted in Some but Not All Cutaneous Tasks

    Science.gov (United States)

    Alary, Flamine; Duquette, Marco; Goldstein, Rachel; Chapman, C. Elaine; Voss, Patrice; La Buissonniere-Ariza, Valerie; Lepore, Franco

    2009-01-01

    Previous studies have shown that blind subjects may outperform the sighted on certain tactile discrimination tasks. We recently showed that blind subjects outperformed the sighted in a haptic 2D-angle discrimination task. The purpose of this study was to compare the performance of the same blind (n = 16) and sighted (n = 17, G1) subjects in three…

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

    Directory of Open Access Journals (Sweden)

    Bathini Chandrahas

    2012-01-01

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

  5. Modafinil alters decision making based on feedback history - a randomized placebo-controlled double blind study in humans.

    Science.gov (United States)

    Bellebaum, Christian; Kuchinke, Lars; Roser, Patrik

    2017-02-01

    Modafinil is becoming increasingly popular as a cognitive enhancer. Research on the effects of modafinil on cognitive function have yielded mixed results, with negative findings for simple memory and attention tasks and enhancing effects for more complex tasks. In the present study we examined whether modafinil, due to its known effect on the dopamine level in the striatum, alters feedback-related choice behaviour. We applied a task that separately tests the choice of previously rewarded behaviours (approach) and avoidance of previously punished behaviours. 18 participants received a single dose of 200 mg modafinil. Their performance was compared to a group of 22 participants who received placebo in a double-blind design. Modafinil but not placebo induced a significant bias towards approach behaviour as compared to the frequency of avoidance behaviour. General attention, overall feedback-based acquisition of choice behaviour and reaction times in high vs low conflict choices were not significantly affected by modafinil. This finding suggests that modafinil has a specific effect on dopamine-mediated choice behaviour based on the history of feedback, while a contribution of noradrenaline is also conceivable. The described change in decision making cannot be considered as cognitive enhancement, but might rather have detrimental effects on decisions in everyday life.

  6. Antidepressants and ejaculation: a double-blind, randomized, placebo-controlled, fixed-dose study with paroxetine, sertraline, and nefazodone.

    Science.gov (United States)

    Waldinger, M D; Zwinderman, A H; Olivier, B

    2001-06-01

    Antidepressant medication is often associated with sexual side effects. A double-blind, placebo-controlled study in men with lifelong rapid ejaculation was performed to assess the effects of two selective serotonin (5-HT) reuptake inhibitors--paroxetine and sertraline--and the 5-HT2 antagonist and 5-HT/noradrenaline reuptake inhibitor nefazodone on the latency to ejaculate. Forty-eight men with an intravaginal ejaculation latency time (IELT) of a maximum of 1 minute were randomly assigned to receive paroxetine (20 mg/day), sertraline (50 mg/day), nefazodone (400 mg/day), or placebo for 6 weeks. During the 1-month baseline and 6-week treatment period, IELTs were measured at home with a stopwatch. The trial was completed by 40 men. During the 6-week treatment period, the geometric mean IELT in the placebo group was stable at approximately 20 seconds. Analysis of variance revealed a between-group difference in the evolution of IELT delay over time (p = 0.002); the IELT after paroxetine and sertraline gradually increased to approximately 146 and 58 seconds, respectively, compared with 28 seconds in the nefazodone group. The paroxetine and sertraline groups differed significantly (p < 0.001 and p = 0.024, respectively) from placebo, but the nefazodone group did not (p = 0.85). Compared with baseline, paroxetine exerted the strongest delay in ejaculation, whereas sertraline delayed it only moderately. There was no clinically relevant delay in ejaculation with nefazodone.

  7. A Prospective Randomized, Double-Blind, Two-Period Crossover Pharmacokinetic Trial Comparing Green Coffee Bean Extract-A Botanically Sourced Caffeine-With a Synthetic USP Control.

    Science.gov (United States)

    Morton, Kayce; Knight, Katelin; Kalman, Douglas; Hewlings, Susan

    2018-04-16

    Coffee is a primary dietary source of the chlorogenic acids (CGAs) of phenolic compounds. Coffee contains caffeine and other phytonutrients, including CGAs. Caffeine on its own has been well characterized and descried pharmacokinetically in the literature, less so for CGAs. The purpose of this double-blind crossover study was to determine the comparative pharmacokinetics of CGAs with caffeine (natural extract) with synthetic caffeine (US Pharmacopeia [USP] standard). Sixteen healthy male subjects were randomly assigned to take 1 dose of product 1, 60 mg of botanically sourced caffeine from 480 mg of green coffee bean extract, or product 2, 60 mg of synthetic USP caffeine, with 5 days between. Blood analysis was done to determine the levels of CGA compounds, more specifically 3-, 4-, and 5-caffeoylquinic acid (CQA), and serum caffeine. The natural caffeine extract exhibited mean peak concentrations (C max ) of 3-CQA (11.4 ng/mL), 4-CQA (6.84 ng/mL), and 5-CQA (7.20 ng/mL). The mean systemic 4-hour exposure (AUC 0-4 h ) was 3-CQA (27.3 ng·h/mL), 4-CQA (16.1 ng·h/mL), and 5-CQA (15.7 ng·h/mL). The median t max was 3-CQA (1.00 hour), 4-CQA (1.00 hour), and 5-CQA (1.50 hours). The t max of caffeine was 0.75 hours (natural extract) and 0.63 hours (synthetic caffeine). C max and AUC 0-4 h of serum caffeine were statistically equivalent between products. The geometric least-squares mean ratios (GMRs) of C max and AUC 0-4 h of caffeine were 97.77% (natural extract) and 98.33% (synthetic caffeine). It would appear that CGA compounds from the natural caffeine extract are bioavailable, and 3-CGA may be the compound most absorbed. In addition, caffeine sourced from natural extract versus synthetic were statistically similar for pharmacokinetic parameters. There were no adverse events or safety concerns. © 2018 The Authors. Clinical Pharmacology in Drug Development Published by Wiley Periodicals, Inc. on behalf of The American College of Clinical Pharmacology.

  8. Prevalence of lactose intolerance in Chile: a double-blind placebo study.

    Science.gov (United States)

    Latorre, Gonzalo; Besa, Pablo; Parodi, Carmen G; Ferrer, Verónica; Azocar, Lorena; Quirola, Marife; Villarroel, Luis; Miquel, Juan F; Agosin, Eduardo; Chianale, José

    2014-01-01

    Lactase non-persistence (LNP), or primary hypolactasia, is a genetic condition that mediates lactose malabsorption and can cause lactose intolerance. Here we report the prevalence of lactose intolerance in a double-blind placebo study. The LCT C>T-13910 variant was genotyped by RT-PCR in 121 volunteers and lactose malabsorption was assessed using the hydrogen breath test (HBT) after consuming 25 g of lactose. Lactose intolerance was assessed by scoring symptoms (SS) using a standardized questionnaire following challenge with a lactose solution or saccharose placebo. The LNP genotype was observed in 57% of the volunteers, among whom 87% were HBT⁺. In the HBT⁺ group the median SS was 9 and in the HBT⁻ group the median SS was 3 (p lactose intolerance was defined as the presence of an SS ≥ 6 points after subtracting the placebo effect and 34% of the study population met this definition. The LNP genotype was present in more than half of subjects evaluated and the observed prevalence of lactose intolerance was 34%. © 2014 S. Karger AG, Basel.

  9. Randomized double-blind placebo-controlled crossover study of caffeine in patients with intermittent claudication.

    Science.gov (United States)

    Momsen, A H; Jensen, M B; Norager, C B; Madsen, M R; Vestersgaard-Andersen, T; Lindholt, J S

    2010-10-01

    Intermittent claudication is a disabling symptom of peripheral arterial disease for which few medical treatments are available. This study investigated the effect of caffeine on physical capacity in patients with intermittent claudication. This randomized double-blind placebo-controlled crossover study included 88 patients recruited by surgeons from outpatient clinics. The participants abstained from caffeine for 48 h before each test and then received either a placebo or oral caffeine (6 mg/kg). After 75 min, pain-free and maximal walking distance on a treadmill, perceived pain, reaction times, postural stability, maximal isometric knee extension strength, submaximal knee extension endurance and cognitive function were measured. The analysis was by intention to treat. Caffeine increased the pain-free walking distance by 20.0 (95 per cent confidence interval 3.7 to 38.8) per cent (P = 0.014), maximal walking distance by 26.6 (12.1 to 43.0) per cent (P postural stability was reduced significantly, by 22.1 (11.7 to 33.4) per cent with eyes open (P < 0.001) and by 21.8 (7.6 to 37.8) per cent with eyes closed (P = 0.002). Neither reaction time nor cognition was affected. In patients with moderate intermittent claudication, caffeine increased walking distance, maximal strength and endurance, but affected balance adversely.

  10. Effect of clinical information in brain CT scan interpretation : a blinded double crossover study

    International Nuclear Information System (INIS)

    Zhianpour, M.; Janghorbani, M.

    2004-01-01

    Errors and variations in interpretation can happen in clinical imaging. Few studies have examined the biased effect of clinical information on reporting of brain CT scans. In a blinded double crossover design, we studied whether three radiologists were biased by clinical information when making CT scan diagnosis of the brain. Three consultant radiologists in three rounds with at least a one month interval assessed 100 consecutive cases of brain CT scan. In the first round, clinical information was not available and 100 films without clinical information were given to radiologists. In the second round, the same 100 films were given and true clinical information was available. In the third round, the same 100 films were given and false clinical information was allocated. In 180 cases (60%) the evaluation resulted in the same diagnosis on all three occasions (95% confidence interval (CI): 54.5, 65.5), whereas 120(40%; 95% CI:34.5, 45.5) sets were evaluated differently. 48 cases (16%; 95% CI:11.9,20.1) had discordant evaluation with true and 33 (11%; 95% CI:7.5, 14.5) with false clinical information. Discordance without and with true and false clinical information was 39 (13%; 95% CI:9.2, 16.8). Correct clinical information improves the brain CT report, while the report became less accurate false clinical information was allocated. These results indicate that radiologists are biased by clinical information when reporting brian CT scans

  11. A comparison of two stretching programs for hamstring muscles: A randomized controlled assessor-blinded study.

    Science.gov (United States)

    Demoulin, Christophe; Wolfs, Sébastien; Chevalier, Madeline; Granado, Caroline; Grosdent, Stéphanie; Depas, Yannick; Roussel, Nathalie; Hage, Renaud; Vanderthommen, Marc

    2016-01-01

    Most parameters regarding hamstring flexibility training programs have been investigated; however, the joint (i.e. hip or knee) on which the stretching should preferentially be focused needs to be further explored. This randomized controlled assessor-blinded study aimed to investigate the influence of this parameter. We randomly assigned 111 asymptomatic participants with tight hamstring muscles in three groups: a control group and two groups following a different home-based 8-week (five 10-minute sessions per week) hamstring stretching program (i.e. stretching performed by flexing the hip while keeping the knee extended [SH] or by first flexing the hip with a flexed knee and then extending the knee [SK]). Range of motion (ROM) of hip flexion and knee extension were measured before and after the stretching program by means of the straight leg raising test and the passive knee extension angle test, respectively. Eighty-nine participants completed the study. A significant increase in ROM was observed at post-test. Analyses showed significant group-by-time interactions for changes regarding all outcomes. Whereas the increase in hip flexion and knee extension ROM was higher in the stretching groups than in the CG (especially for the SH group p 0.05). In conclusion, the fact that both stretching programs resulted in similar results suggests no influence of the joint at which the stretching is focused upon, as assessed by the straight leg raising and knee extension angle tests.

  12. Tolerance of low-frequency ultrasound sonophoresis: a double-blind randomized study on humans.

    Science.gov (United States)

    Maruani, Annabel; Vierron, Emilie; Machet, Laurent; Giraudeau, Bruno; Halimi, Jean-Michel; Boucaud, Alain

    2012-05-01

    Sonophoresis [low-frequency ultrasound (US)] has been used in animals and in vitro to investigate enhanced percutaneous absorption of drugs. No study focused on its clinical human tolerance has been published as yet. We aimed to assess the bioeffects of low-frequency US in vivo on human skin in a double-blind randomized-controlled study. We applied pulse-mode US at 36 kHz for 5 min in a step procedure of increasing dosage, from 1.57 to 3.50 W/cm(2), and placebo. The primary outcome was toxic effects of the procedure, defined as a pain score >40 on a 0-100 mm visual analogue scale or necrosis. Erythema (scored from 0 to 3 in severity) was also evaluated. The secondary outcomes were measurements of skin thickness by high-resolution skin imaging, of skin capacitance and temperature. We included 34 healthy volunteers. We found no pain score >38 and no skin necrosis with either US or placebo. Erythema was systematically observed immediately after US application, but after 1 day, we observed three cases in the knee group. The most frequent adverse effect was tinnitus. We observed no marked increase in temperature or cutaneous thickness after US or placebo. Cutaneous capacitance increased immediately after both applications. Such data demonstrating good tolerance of sonophoresis can be useful before the initiation of a clinical trial of the therapeutic use of low-frequency sonophoresis in humans. © 2011 John Wiley & Sons A/S.

  13. Benfotiamine in diabetic polyneuropathy (BENDIP): results of a randomised, double blind, placebo-controlled clinical study.

    Science.gov (United States)

    Stracke, H; Gaus, W; Achenbach, U; Federlin, K; Bretzel, R G

    2008-11-01

    Efficacy and safety of benfotiamine in treatment of diabetic polyneuropathy. Double blind, placebo-controlled, phase-III-study. 181 patients were screened. 165 patients with symmetrical, distal diabetic polyneuropathy were randomised to one of three treatment groups entering the wash-out phase and 133/124 patients were analysed in the ITT/PP analysis: Benfotiamine 600 mg per day (n=47/43), benfotiamine 300 mg per day (n=45/42) or placebo (n=41/39). After 6 weeks of treatment, the primary outcome parameter NSS (Neuropathy Symptom Score) differed significantly between the treatment groups (p=0.033) in the PP (per protocol) population. In the ITT (intention to treat) population, the improvement of NSS was slightly above significance (p=0.055). The TSS (Total Symptom Score) showed no significant differences after 6 weeks of treatment. The improvement was more pronounced at the higher benfotiamine dose and increased with treatment duration. In the TSS, best results were obtained for the symptom "pain". Treatment was well tolerated in all groups. Benfotiamine may extend the treatment option for patients with diabetic polyneuropathy based on causal influence on impaired glucose metabolism. Further studies should confirm the positive experiences.

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

    Science.gov (United States)

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

    2013-03-01

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

  15. Adjunctive treatment of manic agitation with lorazepam versus haloperidol: a double-blind study.

    Science.gov (United States)

    Lenox, R H; Newhouse, P A; Creelman, W L; Whitaker, T M

    1992-02-01

    While lithium is effective in treating the majority of bipolar patients during a manic episode, the addition of neuroleptic during the early phase of treatment has been common clinical practice in inpatient settings. In an earlier open study, we demonstrated the utility of the short-acting benzodiazepine lorazepam as an adjunct to lithium for the clinical management of manic agitation. We now present data from a randomized, double-blind clinical study of lorazepam versus haloperidol in 20 hospitalized patients with a DSM-III-R diagnosis of bipolar disorder who were being treated concomitantly with lithium. Patients were rated using the Mania Rating Scale, Brief Psychiatric Rating Scale, Physician Global Impression Scale, and side effects scales. Data were analyzed using standard group comparisons and survival analysis. There was no evidence for a significant difference between the two treatment groups in the magnitude of or time to response (5.0 +/- .82 days for haloperidol; 6.5 +/- .93 days for lorazepam). Of the patients who were terminated from the protocol early, nonresponse was the primary reason in the lorazepam group while side effects were the reason in the haloperidol group. Lorazepam may offer an efficacious and safe alternative to haloperidol as an adjunctive treatment to lithium in the clinical management of the early phase of manic agitation in a subgroup of bipolar patients.

  16. Choto-san in the treatment of vascular dementia: a double-blind, placebo-controlled study.

    Science.gov (United States)

    Terasawa, K; Shimada, Y; Kita, T; Yamamoto, T; Tosa, H; Tanaka, N; Saito, Y; Kanaki, E; Goto, S; Mizushima, N; Fujioka, M; Takase, S; Seki, H; Kimura, I; Ogawa, T; Nakamura, S; Araki, G; Maruyama, I; Maruyama, Y; Takaori, S

    1997-03-01

    In an earlier placebo-controlled study, we demonstrated that a kampo (Japanese herbal) medicine called Choto-san (Diao-Teng-San in Chinese) was effective in treating vascular dementia. To evaluate its efficacy using more objective criteria, we carried out a multi-center, double-blind study of Choto-san extract (7.5 g/day) and a placebo, each given three times a day for 12 weeks to patients suffering from this condition. The study enrolled and analyzed 139 patients, 50 males and 89 females, with a mean age of 76.6 years. Choto-san was statistically superior to the placebo in global improvement rating, utility rating, global improvement rating of subjective symptoms, global improvement rating of psychiatric symptoms and global improvement rating of disturbance in daily living activities. Such items as spontaneity of conversation, lack of facial expression, decline in simple mathematical ability, global intellectual ability, nocturnal delirium, sleep disturbance, hallucination or delusion, and putting on and taking off clothes were significantly improved at one or more evaluation points in those taking Choto-san compared to those taking the placebo. Furthermore, the change in revised version of Hasegawa's dementia scale from the beginning point in Choto-san group was tended to be higher than that in placebo group with no statistical significance. These results suggest that Choto-san is effective in the treatment of vascular dementia. Copyright © 1997 Gustav Fischer Verlag. Published by Elsevier GmbH.. All rights reserved.

  17. Salivary Oxytocin Concentrations in Males following Intranasal Administration of Oxytocin: A Double-Blind, Cross-Over Study.

    Science.gov (United States)

    Daughters, Katie; Manstead, Antony S R; Hubble, Kelly; Rees, Aled; Thapar, Anita; van Goozen, Stephanie H M

    2015-01-01

    The use of intranasal oxytocin (OT) in research has become increasingly important over the past decade. Although researchers have acknowledged a need for further investigation of the physiological effects of intranasal administration, few studies have actually done so. In the present double-blind cross-over study we investigated the longevity of a single 24 IU dose of intranasal OT measured in saliva in 40 healthy adult males. Salivary OT concentrations were significantly higher in the OT condition, compared to placebo. This significant difference lasted until the end of testing, approximately 108 minutes after administration, and peaked at 30 minutes. Results showed significant individual differences in response to intranasal OT administration. To our knowledge this is the largest and first all-male within-subjects design study to demonstrate the impact of intranasal OT on salivary OT concentrations. The results are consistent with previous research in suggesting that salivary OT is a valid matrix for OT measurement. The results also suggest that the post-administration 'wait-time' prior to starting experimental tasks could be reduced to 30 minutes, from the 45 minutes typically used, thereby enabling testing during peak OT concentrations. Further research is needed to ascertain whether OT concentrations after intranasal administration follow similar patterns in females, and different age groups.

  18. Salivary Oxytocin Concentrations in Males following Intranasal Administration of Oxytocin: A Double-Blind, Cross-Over Study.

    Directory of Open Access Journals (Sweden)

    Katie Daughters

    Full Text Available The use of intranasal oxytocin (OT in research has become increasingly important over the past decade. Although researchers have acknowledged a need for further investigation of the physiological effects of intranasal administration, few studies have actually done so. In the present double-blind cross-over study we investigated the longevity of a single 24 IU dose of intranasal OT measured in saliva in 40 healthy adult males. Salivary OT concentrations were significantly higher in the OT condition, compared to placebo. This significant difference lasted until the end of testing, approximately 108 minutes after administration, and peaked at 30 minutes. Results showed significant individual differences in response to intranasal OT administration. To our knowledge this is the largest and first all-male within-subjects design study to demonstrate the impact of intranasal OT on salivary OT concentrations. The results are consistent with previous research in suggesting that salivary OT is a valid matrix for OT measurement. The results also suggest that the post-administration 'wait-time' prior to starting experimental tasks could be reduced to 30 minutes, from the 45 minutes typically used, thereby enabling testing during peak OT concentrations. Further research is needed to ascertain whether OT concentrations after intranasal administration follow similar patterns in females, and different age groups.

  19. Effects of SuperUlam on Supporting Concentration and Mood: A Randomized, Double-Blind, Placebo-Controlled Crossover Study

    Directory of Open Access Journals (Sweden)

    Jay K Udani

    2013-01-01

    Full Text Available Background. SuperUlam is a proprietary blend of natural ingredients aimed at supporting brain health. We aimed to evaluate the effect of SuperUlam on attention and mood in healthy adults. Methods. Twenty healthy individuals aged 35–65 were enrolled in this randomized, double-blind, placebo-controlled, crossover study. Study duration was 3 weeks and consisted of 3 visits. Measurement of cognitive function included computer-based testing of reaction time, complex attention, working memory, sustained attention, and executive functioning. Mood testing was performed via the profile of mood states (POMS survey and the Chalder fatigue scale. Results. Cognitive function testing demonstrated a significant improvement from baseline in executive functioning, cognitive flexibility, reaction time, and working memory in the product group only (P<0.05. When comparing the study product to placebo, the data demonstrated a significant decrease in tension, depression, and anger (P<0.05. There was no significant difference between the product and placebo in the other measures of mood, including vigor, fatigue, confusion, and total mood disturbance. No adverse events were reported. Conclusions. Supplementation with SuperUlam is safe to consume with potential benefits to cognitive function and mood.

  20. Effects of SuperUlam on Supporting Concentration and Mood: A Randomized, Double-Blind, Placebo-Controlled Crossover Study.

    Science.gov (United States)

    Udani, Jay K

    2013-01-01

    Background. SuperUlam is a proprietary blend of natural ingredients aimed at supporting brain health. We aimed to evaluate the effect of SuperUlam on attention and mood in healthy adults. Methods. Twenty healthy individuals aged 35-65 were enrolled in this randomized, double-blind, placebo-controlled, crossover study. Study duration was 3 weeks and consisted of 3 visits. Measurement of cognitive function included computer-based testing of reaction time, complex attention, working memory, sustained attention, and executive functioning. Mood testing was performed via the profile of mood states (POMS) survey and the Chalder fatigue scale. Results. Cognitive function testing demonstrated a significant improvement from baseline in executive functioning, cognitive flexibility, reaction time, and working memory in the product group only (P < 0.05). When comparing the study product to placebo, the data demonstrated a significant decrease in tension, depression, and anger (P < 0.05). There was no significant difference between the product and placebo in the other measures of mood, including vigor, fatigue, confusion, and total mood disturbance. No adverse events were reported. Conclusions. Supplementation with SuperUlam is safe to consume with potential benefits to cognitive function and mood.

  1. Aspartame exacerbates EEG spike-wave discharge in children with generalized absence epilepsy: a double-blind controlled study.

    Science.gov (United States)

    Camfield, P R; Camfield, C S; Dooley, J M; Gordon, K; Jollymore, S; Weaver, D F

    1992-05-01

    There are anecdotal reports of increased seizures in humans after ingestion of aspartame. We studied 10 children with newly diagnosed but untreated generalized absence seizures. Ambulatory cassette recording of EEG allowed quantification of numbers and length of spike-wave discharges in a double-blind study on two consecutive days. On one day the children received 40 mg/kg aspartame and on the other day, a sucrose-sweetened drink. Baseline EEG was the same before aspartame and sucrose. Following aspartame compared with sucrose, the number of spike-wave discharges per hour and mean length of spike-wave discharges increased but not to a statistically significant degree. However, the total duration of spike-wave discharge per hour was significantly increased after aspartame (p = 0.028), with a 40% +/- 17% (SEM) increase in the number of seconds per hour of EEG recording that the children spent in spike-wave discharge. Aspartame appears to exacerbate the amount of EEG spike wave in children with absence seizures. Further studies are needed to establish if this effect occurs at lower doses and in other seizure types.

  2. Effect of collagen hydrolysate in articular pain: a 6-month randomized, double-blind, placebo controlled study.

    Science.gov (United States)

    Bruyère, O; Zegels, B; Leonori, L; Rabenda, V; Janssen, A; Bourges, C; Reginster, J-Y

    2012-06-01

    Evaluation of the efficacy and safety of a food supplement made of collagen hydrolysate 1200 mg/day versus placebo during 6 months, in subjects with joint pain at the lower or upper limbs or at the lumbar spine. Comparative double-blind randomized multicenter study in parallel groups. 200 patients of both genders of at least 50 years old with joint pain assessed as ≥30 mm on a visual analogical scale (VAS). Collagen hydrolysate 1200 mg/day or placebo during 6 months. Comparison of the percentage of clinical responder between the active collagen hydrolysate group and the placebo group after 6 months of study. A responder subject was defined as a subject experiencing a clinically significant improvement (i.e. by 20% or more) in the most painful joint using the VAS score. All analyses were performed using an intent-to-treat procedure. At 6 months, the proportion of clinical responders to the treatment, according to VAS scores, was significantly higher in the collagen hydrolysate (CH) group 51.6%, compared to the placebo group 36.5% (pvs. 39.6%, p=0.53). No significant difference in terms of security and tolerability was observed between the two groups. This study suggests that collagen hydrolysate 1200 mg/day could increase the number of clinical responders (i.e. improvement of at least 20% on the VAS) compared to placebo. More studies are needed to confirm the clinical interest of this food supplement. Copyright © 2012 Elsevier Ltd. All rights reserved.

  3. Mathematics education and comparative historical studies

    Directory of Open Access Journals (Sweden)

    Wagner RODRIGUES VALENTE

    2013-11-01

    Full Text Available This paper has as its aims: to characterize the area of research «history of mathematics education» and to defend the idea that mathematics education has constituted a privileged research theme within the field of comparative historical studies. To achieve these aims, the text includes references to a review of the literature concerning comparative studies, the analysis of two fundamental moments focused on attempts to internationalize the mathematics curriculum, both of which occurred during the 20th century, and, to end, a case study emanating from an international cooperation between researchers in Brazil and Portugal.

  4. Comparative study of bioethanol production from sugarcane ...

    African Journals Online (AJOL)

    The study was designed to compare the bioethanol production from Zymomonas mobilis and Saccharomyces cerevisiae using molasses as production medium. The focus was on the retention time at lab scale. Bioethanol and petroleum blend can be used in existing gasoline engines. Present study showed a more ...

  5. Supplementary data: Comparative studies on sequence ...

    Indian Academy of Sciences (India)

    Unknown

    Page 1. Supplementary data: Comparative studies on sequence characteristics around translation initiation codon in four eukaryotes. Qingpo Liu and Qingzhong Xue. J. Genet. 84, 317–322. Table 1. Spearman's rank correlation coefficients of 39 base positions around the AUG codon in the four eukaryotic species studied.

  6. Comparative study between manual injection intraosseous anesthesia and conventional oral anesthesia

    OpenAIRE

    Peñarrocha-Oltra, David; Ata-Ali, Javier; Oltra-Moscardó, María J.; Peñarrocha-Diago, María; Peñarrocha, Miguel

    2011-01-01

    Objective: To compare intraosseous anesthesia (IA) with the conventional oral anesthesia techniques. Materials and methods: A simple-blind, prospective clinical study was carried out. Each patient underwent two anesthetic techniques: conventional (local infiltration and locoregional anesthetic block) and intraosseous, for res-pective dental operations. In order to allow comparison of IA versus conventional anesthesia, the two operations were similar and affected the same two teeth in opposite...

  7. Treatment assignment guesses by study participants in a double-blind dose escalation clinical trial of saw palmetto.

    Science.gov (United States)

    Lee, Jeannette Y; Moore, Page; Kusek, John; Barry, Michael

    2014-01-01

    This report assesses participant perception of treatment assignment in a randomized, double-blind, placebo-controlled trial of saw palmetto for the treatment of benign prostatic hyperplasia (BCM). Participants randomized to receive saw palmetto were instructed to take one 320 mg gelcap daily for the first 24 weeks, two 320 mg gelcaps daily for the second 24 weeks, and three 320 mg gelcaps daily for the third 24 weeks. Study participants assigned to placebo were instructed to take the same number of matching placebo gelcaps in each time period. At 24, 48, and 72 weeks postrandomization, the American Urological Association Symptom Index (AUA-SI) was administered and participants were asked to guess their treatment assignment. The study was conducted at 11 clinical centers in North America. Study participants were men, 45 years and older, with moderate to low severe BPH symptoms, randomized to saw palmetto (N=151) or placebo (N=155). Treatment arms were compared with respect to the distribution of participant guesses of treatment assignment. For participants assigned to saw palmetto, 22.5%, 24.7%, and 29.8% correctly thought they were taking saw palmetto, and 37.3%, 40.0%, and 44.4% incorrectly thought they were on placebo at 24, 48, and 72 weeks, respectively. For placebo participants, 21.8%, 27.4%, and 25.2% incorrectly thought they were on saw palmetto, and 41.6%, 39.9%, and 42.6% correctly thought they were on placebo at 24, 48, and 72 weeks, respectively. The treatment arms did not vary with respect to the distributions of participants who guessed they were on saw palmetto (p=0.823) or placebo (p=0.893). Participants who experienced an improvement in AUA-SI were 2.16 times more likely to think they were on saw palmetto. Blinding of treatment assignment was successful in this study. Improvement in BPH-related symptoms was associated with the perception that participants were taking saw palmetto.

  8. Endoscopic management of intraoperative small bowel laceration during natural orifice translumenal endoscopic surgery: a blinded porcine study.

    Science.gov (United States)

    Fyock, Christopher J; Forsmark, Chris E; Wagh, Mihir S

    2011-01-01

    Natural orifice translumenal endoscopic surgery (NOTES) has recently gained great enthusiasm, but there is concern regarding the ability to endoscopically manage complications purely via natural orifices. To assess the feasibility of endoscopically managing enteral perforation during NOTES using currently available endoscopic accessories. Twelve pigs underwent transgastric or transcolonic endoscopic exploration. Full-thickness enterotomies were intentionally created to mimic accidental small bowel lacerations during NOTES. These lacerations were then closed with endoclips. In the blinded arm of the study, small bowel repair was performed by a second blinded endoscopist. Adequate closure of the laceration was confirmed with a leak test. Primary access sites were closed with endoclips or T-anchors. At necropsy, the peritoneal cavity was inspected for abscesses, bleeding, or damage to surrounding structures. The enterotomy site was examined for adequacy of closure, adhesions, or evidence of infection. Fifteen small bowel lacerations were performed in 12 animals. Successful closure was achieved in all 10 cases in the nonblinded arm. Survival animals had an uncomplicated postoperative course and all enterotomy sites were well healed without evidence of necrosis, adhesions, abscess, or bleeding at necropsy. Leak test was negative in all animals. In the blinded arm, both small intestinal lacerations could not be identified by the blinded endoscopist. Necropsy revealed open small bowel lacerations. Small intestinal injuries are difficult to localize with currently available flexible endoscopes and accessories. Endoscopic clips, however, may be adequate for closure of small bowel lacerations if the site of injury is known.

  9. A randomized, double-blind, placebo-controlled study of oral antioxidant supplement therapy in patients with dry eye syndrome.

    Science.gov (United States)

    Huang, Jehn-Yu; Yeh, Po-Ting; Hou, Yu-Chih

    2016-01-01

    To evaluate the efficacy of oral antioxidant supplementation in the treatment of patients with dry eye syndrome (DES). A prospective, randomized, double-blinded study compared the effects of an antioxidant supplement (containing anthocyanosides, astaxanthin, vitamins A, C, and E, and several herbal extracts, including Cassiae semen and Ophiopogonis japonicus) with placebo on patients with DES. We assessed dry eye symptoms, visual acuity, Schirmer's test, tear film breakup time, cornea and conjunctiva fluorescein staining, serum anti-SSA/anti-SSB antibodies, and the level of reactive oxygen species (ROS) in tears. The supplementation period was 8 weeks and patients were followed up every 4 weeks for 16 weeks. A linear mixed model was used to compare the groups, while within-group differences were tested by repeated-measures analysis of variance. Forty-three patients, 20 and 23 in treatment and placebo groups, respectively, completed the study. Liver and renal functions were normal. Diastolic blood pressure decreased in the treatment group. There were no significant differences in systolic blood pressure, dry eye symptoms, serum anti-SSA and anti-SSB, visual acuity, intraocular pressure, or fluorescein corneal staining between the groups. Tear film breakup time scores and Schirmer's test without topical anesthesia significantly improved in the treatment group. Tear ROS level differed between the groups and decreased after treatment. Overall subjective impression revealed a significant improvement with treatment compared with placebo. Oral antioxidant supplementations may increase tear production and improve tear film stability by reducing tear ROS. The vegetable-based antioxidant supplement used in this study is safe and can be utilized as an adjuvant therapy to conventional artificial tear therapy for patients with DES.

  10. A randomized, double-blind, placebo-controlled study of oral antioxidant supplement therapy in patients with dry eye syndrome

    Directory of Open Access Journals (Sweden)

    Huang JY

    2016-05-01

    Full Text Available Jehn-Yu Huang, Po-Ting Yeh, Yu-Chih Hou Department of Ophthalmology, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan Purpose: To evaluate the efficacy of oral antioxidant supplementation in the treatment of patients with dry eye syndrome (DES. Methods: A prospective, randomized, double-blinded study compared the effects of an antioxidant supplement (containing anthocyanosides, astaxanthin, vitamins A, C, and E, and several herbal extracts, including Cassiae semen and Ophiopogonis japonicus with placebo on patients with DES. We assessed dry eye symptoms, visual acuity, Schirmer’s test, tear film breakup time, cornea and conjunctiva fluorescein staining, serum anti-SSA/anti-SSB antibodies, and the level of reactive oxygen species (ROS in tears. The supplementation period was 8 weeks and patients were followed up every 4 weeks for 16 weeks. A linear mixed model was used to compare the groups, while within-group differences were tested by repeated-measures analysis of variance. Results: Forty-three patients, 20 and 23 in treatment and placebo groups, respectively, completed the study. Liver and renal functions were normal. Diastolic blood pressure decreased in the treatment group. There were no significant differences in systolic blood pressure, dry eye symptoms, serum anti-SSA and anti-SSB, visual acuity, intraocular pressure, or fluorescein corneal staining between the groups. Tear film breakup time scores and Schirmer’s test without topical anesthesia significantly improved in the treatment group. Tear ROS level differed between the groups and decreased after treatment. Overall subjective impression revealed a significant improvement with treatment compared with placebo. Conclusion: Oral antioxidant supplementations may increase tear production and improve tear film stability by reducing tear ROS. The vegetable-based antioxidant supplement used in this study is safe and can be utilized as

  11. Quantitative fetal fibronectin and cervical length in symptomatic women: results from a prospective blinded cohort study.

    Science.gov (United States)

    Levine, Lisa D; Downes, Katheryne L; Romero, Julie A; Pappas, Hope; Elovitz, Michal A

    2018-05-15

    Our objectives were to determine whether quantitative fetal fibronectin (fFN) and cervical length (CL) screening can be used alone or in combination as prognostic tests to identify symptomatic women at the highest or lowest risk for spontaneous preterm birth (sPTB). A prospective, blinded cohort study of women presenting with a singleton gestation to our triage unit between 22-33w6d with preterm labor symptoms was performed. Women with ruptured membranes, moderate/severe bleeding, and dilation >2 cm were excluded. The primary outcome was sPTB quantitative fFN and CL assessment, both separately and in combination, considering traditionally reported cut-points (fFN ≥50 and CL 50 and CL quantitative level chosen. For all women, a shorter CL was associated with an increased sPTB risk. Among nulliparas and multiparas without a prior sPTB, a CL quantitative fFN or cervical length assessment can be utilized, depending on resources available, but a lower cut-point of 20 ng/mL should be used for quantitative fFN. For multiparous women, fFN is not useful and cervical length assessment should be the main screening tool utilized when there is clinical uncertainty. Regardless of parity, the PPV of fFN and CL is low and therefore the greatest clinical utility remains in its NPV.

  12. Health service accreditation as a predictor of clinical and organisational performance: a blinded, random, stratified study.

    Science.gov (United States)

    Braithwaite, Jeffrey; Greenfield, David; Westbrook, Johanna; Pawsey, Marjorie; Westbrook, Mary; Gibberd, Robert; Naylor, Justine; Nathan, Sally; Robinson, Maureen; Runciman, Bill; Jackson, Margaret; Travaglia, Joanne; Johnston, Brian; Yen, Desmond; McDonald, Heather; Low, Lena; Redman, Sally; Johnson, Betty; Corbett, Angus; Hennessy, Darlene; Clark, John; Lancaster, Judie

    2010-02-01

    Despite the widespread use of accreditation in many countries, and prevailing beliefs that accreditation is associated with variables contributing to clinical care and organisational outcomes, little systematic research has been conducted to examine its validity as a predictor of healthcare performance. To determine whether accreditation performance is associated with self-reported clinical performance and independent ratings of four aspects of organisational performance. Independent blinded assessment of these variables in a random, stratified sample of health service organisations. Acute care: large, medium and small health-service organisations in Australia. Study participants Nineteen health service organisations employing 16 448 staff treating 321 289 inpatients and 1 971 087 non-inpatient services annually, representing approximately 5% of the Australian acute care health system. Correlations of accreditation performance with organisational culture, organisational climate, consumer involvement, leadership and clinical performance. Results Accreditation performance was significantly positively correlated with organisational culture (rho=0.618, p=0.005) and leadership (rho=0.616, p=0.005). There was a trend between accreditation and clinical performance (rho=0.450, p=0.080). Accreditation was unrelated to organisational climate (rho=0.378, p=0.110) and consumer involvement (rho=0.215, p=0.377). Accreditation results predict leadership behaviours and cultural characteristics of healthcare organisations but not organisational climate or consumer participation, and a positive trend between accreditation and clinical performance is noted.

  13. SSRIs and ejaculation: a double-blind, randomized, fixed-dose study with paroxetine and citalopram.

    Science.gov (United States)

    Waldinger, M D; Zwinderman, A H; Olivier, B

    2001-12-01

    Selective serotonin reuptake inhibitors (SSRIs) are known to induce delayed orgasm and ejaculation. However, different SSRIs may differentially delay ejaculation. A double-blind, fixed-dose study in healthy men with lifelong rapid ejaculation was performed to evaluate potential differences between clinically relevant doses of two selective serotonin reuptake inhibitors, paroxetine and citalopram, in their effects on ejaculation. Thirty men with an intravaginal ejaculation latency time (IELT) less than 1 minute were randomly assigned to receive paroxetine (20 mg/day) and citalopram (20 mg/day) for 5 weeks, after taking half the dosage in the first week. During the 1-month baseline and 6-week treatment period, IELTs were measured at home by using a stopwatch procedure. The trial was completed by 23 men. Analysis of variance revealed a between-group difference in the evolution of IELT delay over time (p = 0.0004); the IELT after paroxetine and citalopram gradually increased from 18 and 21 seconds to approximately 170 and 44 seconds, respectively. Paroxetine 20 mg/day exerted a strong delay (8.9-fold increase), whereas citalopram 20 mg/day mildly delayed ejaculation (1.8-fold increase). These results indicate that paroxetine leads to a significant delay in orgasm and ejaculation, whereas citalopram seems to have less of an effect on it.

  14. Efficacy of sucralfate in the postoperative management of uvulopalatopharyngoplasty: a double-blind, randomized, controlled study.

    Science.gov (United States)

    Zodpe, Prakash; Cho, Jae Gu; Kang, Hee Joon; Hwang, Soon Jae; Lee, Heung-Man

    2006-10-01

    To evaluate the effectiveness of sucralfate in influencing throat pain, otalgia, analgesic requirement, bleeding, mucosal recovery, and incidence of postoperative bleeding in patients undergoing uvulopalatopharyngoplasty. A prospective double-blind randomized study. University-affiliated tertiary referral hospital. Eighty adult patients with obstructive sleep apnea syndrome requiring uvulopalatopharyngoplasty were recruited and randomly allocated into either a sucralfate treatment group or a control group. All patients underwent uvulopalatopharyngoplasty. Patients enrolled in the sucralfate group (n=40) were instructed to gargle the sucralfate suspension and then to swallow. Patients enrolled in the control group (n=40) were instructed to gargle placebo suspension at the same doses and schedule. Postoperative throat pain, otalgia, amount of analgesic required, degree of strength (defined as patients' general well-being and return to regular daily activities), percentage of mucosal covering, and postoperative bleeding. Throat pain and otalgia occurred significantly less often in sucralfate group, with less analgesic requirement and with rapid mucosal healing and early return to regular daily activities. There was no significant difference in episodes of postoperative bleeding between the 2 groups (P=.37). Although sucralfate therapy may not provide complete analgesia after uvulopalatopharyngoplasty, it may reduce the amount of analgesic required, thus preventing dose-related adverse effects from the analgesic agent. It can also significantly reduce the total number of days needed to return to normal daily activities (P=.41).

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

    Science.gov (United States)

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

    2015-01-01

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

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

    Science.gov (United States)

    Kumral, Tolgar Lütfi; Yıldırım, Güven; Berkiten, Güler; Saltürk, Ziya; Ataç, Enes; Atar, Yavuz; Uyar, Yavuz

    2016-01-01

    Objectives. To evaluate the efficacy of trimetazidine dihydrochloride as a treatment for chronic tinnitus. Methods. A total of 97 chronic tinnitus patients were evaluated in this randomized, prospective, double-blind, placebo-controlled trial. After assessing for eligibility, 82 patients were randomly assigned into placebo or trimetazidine groups according to the medication. The trimetazidine group received 20×3 mg/day per oral trimetazidine dihydrochloride and the placebo group received 20×3 mg/day per oral placebo for 3 months. Tinnitus handicap inventory (THI), visual analogue scale (VAS) questionnaires and audiometric results were used to determine the effectiveness of trimetazidine treatment. Results. The study group comprised 82 tinnitus subjects, 42 (51%) of whom received trimetazidine dihydrochloride and 40 (49%) who received placebo. There was no significant difference between placebo and trimetazidine groups in THI grade and VAS (both pre- and posttreatment scores) (P>0.05) and no significant improvement was observed in subjective loudness score in either group (P>0.05). Additionally there was no significant difference between groups in pre- and posttreatment pure tone hearing thresholds at all measured frequencies (P>0.05). Conclusion. Trimetazidine dihydrochloride therapy was ineffective for relieving chronic tinnitus. PMID:27230273

  17. Study of monolithic integrated solar blind GaN-based photodetectors

    Science.gov (United States)

    Wang, Ling; Zhang, Yan; Li, Xiaojuan; Xie, Jing; Wang, Jiqiang; Li, Xiangyang

    2018-02-01

    Monolithic integrated solar blind devices on the GaN-based epilayer, which can directly readout voltage signal, were fabricated and studied. Unlike conventional GaN-based photodiodes, the integrated devices can finish those steps: generation, accumulation of carriers and conversion of carriers to voltage. In the test process, the resetting voltage was square wave with the frequency of 15 and 110 Hz, its maximal voltage of ˜2.5 V. Under LEDs illumination, the maximum of voltage swing is about 2.5 V, and the rise time of voltage swing from 0 to 2.5 V is only about 1.6 ms. However, in dark condition, the node voltage between detector and capacitance nearly decline to zero with time when the resetting voltage was equal to zero. It is found that the leakage current in the circuit gives rise to discharge of the integrated charge. Storage mode operation can offer gain, which is advantage to detection of weak photo signal.

  18. COMPARATIVE STUDY OF NALBUPHINE VS. PENTAZOCINE FOR POSTOPERATIVE ANALGESIA

    Directory of Open Access Journals (Sweden)

    Naresh Ganpatrao Tirpude

    2016-10-01

    Full Text Available BACKGROUND To provide postoperative pain relief is a prime duty of health care providers. Failure to relieve pain is morally and ethically unacceptable. Post-operative pain may results in adverse effects such as: a Physiological Changes: Reduced pulmonary functions, e.g. vital capacity, tidal volume, functional residual capacity; sympathetic stimulation; reduced the physical activity of patients; thereby increasing the risk of venous thrombosis. b Psychological disturbances: Anger, Resentment, Depression, Adversarial Relationship with Doctors, Insomnia. Aim of this study was 1. To investigate whether “Postoperative analgesia with Nalbuphine is longer than Pentazocine”. 2. To investigate whether “Side effects/complications are less with Nalbuphine as compared to Pentazocine”. MATERIALS AND METHODS It was a prospective randomized double blind observational study. Eighty patients of hydrocoele & inguinal hernia were operated under spinal anaesthesia of age group 20-70 years, ASA grade I & II & patients with controlled co-morbid conditions. In postoperative period, Group N- Inj. Nalbuphine (0.3 mg/kg IM or Group P- Inj. Pentazocine (0.5 mg/kg IM was administered to provide postoperative pain relief & to know the duration of pain relief & its side effects. RESULTS On statistical analysis, demographic data i.e. age, sex had no influence on outcome of study. Mean VAS score in group N was highly significant (p-value in Inj. Pentazocine group. 2. Side Effects - Incidence of sedation was more in Nalbuphine group as compared to Pentazocine group. Nausea & Vomiting were more so in Pentazocine group as compared to Nalbuphine group. Limitation of the present study was that sample size was very small.

  19. A double blind, randomised, parallel group study on the efficacy and safety of treating acute lateral ankle sprain with oral hydrolytic enzymes

    NARCIS (Netherlands)

    Kerkhoffs, G. M. M. J.; Struijs, P. A. A.; de Wit, C.; Rahlfs, V. W.; Zwipp, H.; van Dijk, C. N.

    2004-01-01

    Objective: To compare the effectiveness and safety of the triple combination Phlogenzym ( rutoside, bromelain, and trypsin) with double combinations, the single substances, and placebo. Design: Multinational, multicentre, double blind, randomised, parallel group design with eight groups structured

  20. Oral lysine clonixinate in the acute treatment of migraine: a double-blind placebo-controlled study.

    Science.gov (United States)

    Krymchantowski, A V; Barbosa, J S; Cheim, C; Alves, L A

    2001-03-01

    Several oral nonsteroidal anti-inflammatory drugs (NSAIDs) are effective to treat migraine attacks. Lysine clonixinate (LC) is a NSAID derived from nicotinic acid that has proven to be effective in various pain syndromes such as renal colic and muscular pain. The aim of this double-blind, placebo-controlled study was to evaluate the efficacy of oral LC compared to placebo in the acute treatment of migraine. Sixty four patients with the diagnosis of migraine, according to the IHS criteria, were studied prospectively. Patients received LC or placebo once the headache reached moderate or severe intensity for 6 consecutive attacks. With regard to the moderate attacks, LC was superior than placebo after 1, 2 and 4 hours. The consumption of other rescue medications after 4 hours was significantly higher in the placebo group. With regard to the severe attacks, there was no difference between the active drug group and the placebo group concerning headache intensity and consumption of other rescue medications. We conclude that the NSAID lysine clonixinate is effective in treating moderately severe migraine attacks. It is not superior than placebo in treating severe migraine attacks.

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

    Directory of Open Access Journals (Sweden)

    Shah Gaurang R

    2012-09-01

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

  2. Topical Colchicine Gel versus Diclofenac Sodium Gel for the Treatment of Actinic Keratoses: A Randomized, Double-Blind Study.

    Science.gov (United States)

    Faghihi, Gita; Elahipoor, Azam; Iraji, Fariba; Behfar, Shadi; Abtahi-Naeini, Bahareh

    2016-01-01

    Introduction. Actinic keratoses (AKs), a premalignant skin lesion, are a common lesion in fair skin. Although destructive treatment remains the gold standard for AKs, medical therapies may be preferable due to the comfort and reliability .This study aims to compare the effects of topical 1% colchicine gel and 3% diclofenac sodium gel in AKs. Materials and Methods. In this randomized double-blind study, 70 lesions were selected. Patients were randomized before receiving either 1% colchicine gel or 3% diclofenac sodium cream twice a day for 6 weeks. Patients were evaluated in terms of their lesion size, treatment complications, and recurrence at 7, 30, 60, and 120 days after treatment. Results. The mean of changes in the size was significant in both groups both before and after treatment ( 0.05). No case of erythema was seen in the colchicine group, while erythema was seen in 22.9% (eight cases) of patients in the diclofenac sodium group (p = 0.005). Conclusions. 1% colchicine gel was a safe and effective medication with fewer side effects and lack of recurrence of the lesion.

  3. Topical Colchicine Gel versus Diclofenac Sodium Gel for the Treatment of Actinic Keratoses: A Randomized, Double-Blind Study

    Directory of Open Access Journals (Sweden)

    Gita Faghihi

    2016-01-01

    Full Text Available Introduction. Actinic keratoses (AKs, a premalignant skin lesion, are a common lesion in fair skin. Although destructive treatment remains the gold standard for AKs, medical therapies may be preferable due to the comfort and reliability .This study aims to compare the effects of topical 1% colchicine gel and 3% diclofenac sodium gel in AKs. Materials and Methods. In this randomized double-blind study, 70 lesions were selected. Patients were randomized before receiving either 1% colchicine gel or 3% diclofenac sodium cream twice a day for 6 weeks. Patients were evaluated in terms of their lesion size, treatment complications, and recurrence at 7, 30, 60, and 120 days after treatment. Results. The mean of changes in the size was significant in both groups both before and after treatment ( 0.05. No case of erythema was seen in the colchicine group, while erythema was seen in 22.9% (eight cases of patients in the diclofenac sodium group (p = 0.005. Conclusions. 1% colchicine gel was a safe and effective medication with fewer side effects and lack of recurrence of the lesion.

  4. Saffron improved depression and reduced homocysteine level in patients with major depression: A Randomized, double-blind study

    Directory of Open Access Journals (Sweden)

    Gholamali Jelodar

    2017-12-01

    Full Text Available Objectives: A correlation between hyperhomocysteinemia, and depression has been reported. Saffron (Crocus sativus is recommended for treatment of depression; hence, in this study the effect of co-administration of saffron and fluoxetine on plasma homocysteine and depression was evaluated. Material and methods: This was a 4-week randomized and double-blind clinical trial which was conducted from March 2013 to February 2014. In this trial, 40 male and females (20-55 years old diagnosed with severe depression were selected and following filing the Beck form, were randomly divided into two groups.  Experimental group was treated with fluoxetine 20 mg/day and saffron 30 mg /day and the control group received placebo and fluoxetine 20 mg/day for four weeks. Before treatment and at the end of the study, fasting blood samples were collected. For females, blood samples were collected on the third day of their menstrual cycle. Results: A significant reduction of homocysteine levels was observed in both sex in the experimental group compared to before treatment (p

  5. The efficacy of cyclosporine A in cats with presumed atopic dermatitis: a double blind, randomised prednisolone-controlled study.

    Science.gov (United States)

    Wisselink, Marinus A; Willemse, Ton

    2009-04-01

    The objective of this study was to compare the efficacy of cyclosporine A (CsA) and prednisolone in feline atopic dermatitis (AD) in a randomised, controlled double blind study. Twenty-nine cats with feline AD were randomly allocated to two groups. Eleven cats were treated orally with prednisolone (1mg/kg SID) and 18 were treated with CsA (5mg/kg/day) for 4 weeks. At day 0 (D0) and D28, skin lesions were graded by means of the canine atopic dermatitis extent and severity index (CADESI). Skin biopsies and intradermal allergy tests were performed at D0 and blood samples for haematology and serum biochemistry were collected at D0 and D28. During the trial the cat owners were asked to evaluate the intensity of the pruritus once weekly on a linear analog scale and to record side effects. Based on the CADESI there was no significant difference between the two groups in the amount of remission (P=0.0562) or in the number of cats that improved by >25% (P=0.0571). The effect of CsA and prednisolone on pruritus as evaluated by the owners was not significantly different (P=0.41) between the two groups. No serious side effects were observed. The conclusion was that CsA is an effective alternative to prednisolone therapy in cats with presumed atopic dermatitis.

  6. Do TETRA (Airwave) base station signals have a short-term impact on health and well-being? A randomized double-blind provocation study.

    Science.gov (United States)

    Wallace, Denise; Eltiti, Stacy; Ridgewell, Anna; Garner, Kelly; Russo, Riccardo; Sepulveda, Francisco; Walker, Stuart; Quinlan, Terence; Dudley, Sandra; Maung, Sithu; Deeble, Roger; Fox, Elaine

    2010-06-01

    "Airwave" is the new communication system currently being rolled out across the United Kingdom for the police and emergency services, based on the Terrestrial Trunked Radio Telecommunications System (TETRA). Some police officers have complained about skin rashes, nausea, headaches, and depression as a consequence of using their Airwave handsets. In addition, a small subgroup in the population self-report being sensitive to electromagnetic fields (EMFs) in general. We conducted a randomized double-blind provocation study to establish whether short-term exposure to a TETRA base station signal has an impact on the health and well-being of individuals with self-reported "electrosensitivity" and of participants who served as controls. Fifty-one individuals with self-reported electrosensitivity and 132 age- and sex-matched controls participated in an open provocation test; 48 sensitive and 132 control participants went on to complete double-blind tests in a fully screened semianechoic chamber. Heart rate, skin conductance, and blood pressure readings provided objective indices of short-term physiological response. Visual analog scales and symptom scales provided subjective indices of well-being. We found no differences on any measure between TETRA and sham (no signal) under double-blind conditions for either controls or electrosensitive participants, and neither group could detect the presence of a TETRA signal at rates greater than chance (50%). When conditions were not double blind, however, the self-reported electrosensitive individuals did report feeling worse and experienced more severe symptoms during TETRA compared with sham. Our findings suggest that the adverse symptoms experienced by electrosensitive individuals are due to the belief of harm from TETRA base stations rather than to the low-level EMF exposure itself.

  7. Comparative Studies: historical, epistemological and methodological notes

    Directory of Open Access Journals (Sweden)

    Juan Ignacio Piovani

    2017-09-01

    Full Text Available In this article some historical, epistemological and methodological issues related to comparative studies in the social sciences are addressed, with specific reference to the field of education. The starting point is a discussion of the meaning of comparison, its logical structure and its presence in science and in everyday life. It follows the presentation and critical appraisal of the perspectives regarding comparison as a scientific method. It is argued that, even rejecting this restrictive meaning of comparison as a method, there is some consensus on the specificity of comparative studies within the social sciences. And in relation to them, the article address in more detail those studies that can be defined as trans-contextual (cross-national and cross-cultural, with emphasis on the main methodological and technical challenges they face. The socio-historical comparative perspective, which has gained importance in recent years in the field of education, is also discussed.

  8. A Comparative Study on Error Analysis

    DEFF Research Database (Denmark)

    Wu, Xiaoli; Zhang, Chun

    2015-01-01

    Title: A Comparative Study on Error Analysis Subtitle: - Belgian (L1) and Danish (L1) learners’ use of Chinese (L2) comparative sentences in written production Xiaoli Wu, Chun Zhang Abstract: Making errors is an inevitable and necessary part of learning. The collection, classification and analysis...... the occurrence of errors either in linguistic or pedagogical terms. The purpose of the current study is to demonstrate the theoretical and practical relevance of error analysis approach in CFL by investigating two cases - (1) Belgian (L1) learners’ use of Chinese (L2) comparative sentences in written production...... of errors in the written and spoken production of L2 learners has a long tradition in L2 pedagogy. Yet, in teaching and learning Chinese as a foreign language (CFL), only handful studies have been made either to define the ‘error’ in a pedagogically insightful way or to empirically investigate...

  9. Paracetamol sharpens reflection and spatial memory: a double-blind randomized controlled study in healthy volunteers.

    Science.gov (United States)

    Pickering, Gisèle; Macian, Nicolas; Dubray, Claude; Pereira, Bruno

    2016-01-01

    Acetaminophen (APAP, paracetamol) mechanism for analgesic and antipyretic outcomes has been largely addressed, but APAP action on cognitive function has not been studied in humans. Animal studies have suggested an improved cognitive performance but the link with analgesic and antipyretic modes of action is incomplete. This study aims at exploring cognitive tests in healthy volunteers in the context of antinociception and temperature regulation. A double-blind randomized controlled study (NCT01390467) was carried out from May 30, 2011 to July 12, 2011. Forty healthy volunteers were included and analyzed. Nociceptive thresholds, core temperature (body temperature), and a battery of cognitive tests were recorded before and after oral APAP (2 g) or placebo: Information sampling task for predecisional processing, Stockings of Cambridge for spatial memory, reaction time, delayed matching of sample, and pattern recognition memory tests. Analysis of variance for repeated measures adapted to crossover design was performed and a two-tailed type I error was fixed at 5%. APAP improved information sampling task (diminution of the number of errors, latency to open boxes, and increased number of opened boxes; all P memory initial thinking time were decreased ( P =0.04). All other tests were not modified by APAP. APAP had an antinociceptive effect ( P body temperature did not change. This study shows for the first time that APAP sharpens decision making and planning strategy in healthy volunteers and that cognitive performance and antinociception are independent of APAP effect on thermogenesis. We suggest that cognitive performance mirrors the analgesic rather than thermic cascade of events, with possibly a central role for serotonergic and cannabinoid systems that need to be explored further in the context of pain and cognition.

  10. Analgesic control after hip arthroscopy: a randomised, double-blinded trial comparing portal with intra-articular infiltration of bupivacaine.

    LENUS (Irish Health Repository)

    Baker, Joseph F

    2011-06-07

    Abstract: The optimum anaesthetic and analgesic management following hip arthroscopy is yet to be determined. There is, in addition, some concern over the use of intraarticular local anaesthetic. We compared the analgesic efficacy of intra-articular infiltration compared with portal infiltration of bupivacaine following hip arthroscopy. Patients were randomised to receive either 10ml of 0.25% bupivacaine either into the joint or around the portal sites following completion of surgery. 73 patients were recruited (40 intra-articular). The portal infiltration group required significantly more rescue analgesia immediately after surgery (2.33mg vs.0.57mg, p=0.036). Visual Analogue Scale pain scores were not significantly different at 1 and 2 hours following surgery, but at 6 hours the portal group had significantly lower VAS scores (p=0.0036). We believe that the initial pain following surgery results from capsular injury and this explains the need for more rescue analgesia in the portal infiltration group. Further work is needed to establish the ideal regimen. A combination of portal and intra-articular infiltration may be the most efficacious.

  11. [Visual impairment and blindness in children in a Malawian school for the blind].

    Science.gov (United States)

    Schulze Schwering, M; Nyrenda, M; Spitzer, M S; Kalua, K

    2013-08-01

    The aim of this study was to determine the anatomic sites of severe visual impairment and blindness in children in an integrated school for the blind in Malawi, and to compare the results with those of previous Malawian blind school studies. Children attending an integrated school for the blind in Malawi were examined in September 2011 using the standard WHO/PBL eye examination record for children with blindness and low vision. Visual acuity [VA] of the better eye was classified using the standardised WHO reporting form. Fifty-five pupils aged 6 to 19 years were examined, 39 (71 %) males, and 16 (29 %) females. Thirty eight (69%) were blind [BL], 8 (15 %) were severely visually impaired [SVI], 8 (15 %) visually impaired [VI], and 1 (1.8 %) was not visually impaired [NVI]. The major anatomic sites of visual loss were optic nerve (16 %) and retina (16 %), followed by lens/cataract (15 %), cornea (11 %) and lesions of the whole globe (11 %), uveal pathologies (6 %) and cortical blindness (2 %). The exact aetiology of VI or BL could not be determined in most children. Albinism accounted for 13 % (7/55) of the visual impairments. 24 % of the cases were considered to be potentially avoidable: refractive amblyopia among pseudophakic patients and corneal scaring. Optic atrophy, retinal diseases (mostly albinism) and cataracts were the major causes of severe visual impairment and blindness in children in an integrated school for the blind in Malawi. Corneal scarring was now the fourth cause of visual impairment, compared to being the commonest cause 35 years ago. Congenital cataract and its postoperative outcome were the commonest remedial causes of visual impairment. Georg Thieme Verlag KG Stuttgart · New York.

  12. Spatial imagery relies on a sensory independent, though sensory sensitive, functional organization within the parietal cortex: a fMRI study of angle discrimination in sighted and congenitally blind individuals.

    Science.gov (United States)

    Bonino, Daniela; Ricciardi, Emiliano; Bernardi, Giulio; Sani, Lorenzo; Gentili, Claudio; Vecchi, Tomaso; Pietrini, Pietro

    2015-02-01

    Although vision offers distinctive information to space representation, individuals who lack vision since birth often show perceptual and representational skills comparable to those found in sighted individuals. However, congenitally blind individuals may result in impaired spatial analysis, when engaging in 'visual' spatial features (e.g., perspective or angle representation) or complex spatial mental abilities. In the present study, we measured behavioral and brain responses using functional magnetic resonance imaging in sighted and congenitally blind individuals during spatial imagery based on a modified version of the mental clock task (e.g., angle discrimination) and a simple recognition control condition, as conveyed across distinct sensory modalities: visual (sighted individuals only), tactile and auditory. Blind individuals were significantly less accurate during the auditory task, but comparable-to-sighted during the tactile task. As expected, both groups showed common neural activations in intraparietal and superior parietal regions across visual and non-visual spatial perception and imagery conditions, indicating the more abstract, sensory independent functional organization of these cortical areas, a property that we named supramodality. At the same time, however, comparisons in brain responses and functional connectivity patterns across experimental conditions demonstrated also a functional lateralization, in a way that correlated with the distinct behavioral performance in blind and sighted individuals. Specifically, blind individuals relied more on right parietal regions, mainly in the tactile and less in the auditory spatial processing. In sighted, spatial representation across modalities relied more on left parietal regions. In conclusions, intraparietal and superior parietal regions subserve supramodal spatial representations in sighted and congenitally blind individuals. Differences in their recruitment across non-visual spatial processing in

  13. Lysine clonixinate in minor dental surgery: double-blind randomized parallel study versus paracetamol.

    Science.gov (United States)

    Martí, M L; De los Santos, A R; Di Girolamo, G; Gil, M; Manero, E O; Fraga, C

    1993-01-01

    Lysine clonixinate (LC), an effective and well tolerated non-morphinic analgesic whose mechanism of action is basically due to the inhibition of cyclo-oxygenase, was assessed with a double-blind randomized dummy design versus paracetamol (P) on 200 patients suffering from pain after minor dental surgery. Patients received according to their needs 1 or 2 tablets of 125 mg lysine clonixinate or 500 mg paracetamol every 8 h during 48 h or until pain relief. Both groups, each composed of 100 patients, were comparable in terms of demographic conditions (t test), initial symptoms (chi-square test), characteristics of the extracted dental pieces, surgical complications and wound treatment (chi-square test). Pain intensity scores and daily average intake of tablets (3.4/day) documented in the patients' diary revealed no statistically significant differences between the two treatments (chi-square test). It was found that spontaneous pain measured using a visual analogue scale (VAS) decreased significantly in both treatment groups at the 24-h control examination. The following values were observed in the LC group: baseline 4.38 +/- 1.7; 24-h * 1.20 +/- 1.4; 48-h * 0.36 +/- 1.2. In the P group the values were: baseline 4.28 +/- 1.6; 24-h * 1.11 +/- 1.4; 48-h * 0.30 +/- 0.7 (*p < 0.05). Other variables like facial swelling and night pain, evaluated on a score from 0 to 4 and symptom presence or absence respectively, showed a similar response.(ABSTRACT TRUNCATED AT 250 WORDS)

  14. 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.

  15. Prevalence and causes of low vision and blindness in a rural Southwest Island of Japan: the Kumejima study.

    Science.gov (United States)

    Nakamura, Yuko; Tomidokoro, Atsuo; Sawaguchi, Shoichi; Sakai, Hiroshi; Iwase, Aiko; Araie, Makoto

    2010-12-01

    To determine the prevalence and causes of low vision and blindness in an adult population on a rural southwest island of Japan. Population-based, cross-sectional study. All residents of Kumejima Island, Japan, 40 years of age and older. Of the 4632 residents 40 years of age and older, 3762 (response rate, 81.2%) underwent a detailed ocular examination including measurement of the best-corrected visual acuity (BCVA) with a Landolt ring chart at 5 m. The age- and gender-specific prevalence rates of low vision and blindness were estimated and causes were identified. Low vision and blindness were defined, according to the definition of the World Health Organization, as a BCVA in the better eye below 20/60 to a lower limit of 20/400 and worse than 20/400, respectively. The prevalence of bilateral low vision was 0.58% (95% confidence interval [CI], 0.38-0.89). The primary causes of low vision were cataract (0.11%), corneal opacity (0.08%), retinitis pigmentosa (RP; 0.06%), and diabetic retinopathy (0.06%). The prevalence of bilateral blindness was 0.39% (95% CI, 0.23-0.65). The primary causes of blindness were RP (0.17%) and glaucoma (0.11%). The primary causes of monocular low vision were cataract (0.65%), corneal opacity (0.16%), age-related macular degeneration (0.16%), and diabetic retinopathy (0.11%), whereas those of monocular blindness were cataract (0.29%), trauma (0.25%), and glaucoma (0.22%). Logistic analysis showed that female gender (P = 0.001; odds ratio [OR], 7.37; 95% CI, 2.20-24.71) and lower body weight (P = 0.015; OR, 0.94; 95% CI, 0.90-0.99) were associated significantly with visual impairment. The prevalences of low vision and blindness in the adult residents of an island in southwest Japan were 1.5 to 3 times higher than the prevalences reported in an urban city on the Japanese mainland. The prevalence of visual impairment caused by RP on this island was much higher than on the mainland, suggesting a genetic characteristic of the population

  16. Preliminary report: prescription of prism-glasses by the Measurement and Correction Method of H.-J. Haase or by conventional orthoptic examination: a multicenter, randomized, double-blind, cross-over study

    NARCIS (Netherlands)

    Simonsz, H. J.; van Els, J.; Ruijter, J. M.; Bakker, D.; Spekreijse, H.

    2001-01-01

    In a multicenter, randomized, double-blind, cross-over study in the Netherlands, the effectiveness of (prism-)glasses prescribed by the Measurement and Correction Method of H.-J. Haase (MKH) was compared to that of glasses prescribed by conventional orthoptic examination. Nine pairs of

  17. The effects of assertiveness training in patients with schizophrenia: a randomized, single-blind, controlled study.

    Science.gov (United States)

    Lee, Tso-Ying; Chang, Shih-Chin; Chu, Hsin; Yang, Chyn-Yng; Ou, Keng-Liang; Chung, Min-Huey; Chou, Kuei-Ru

    2013-11-01

    In this study, we investigated the effects of group assertiveness training on assertiveness, social anxiety and satisfaction with interpersonal communication among patients with chronic schizophrenia. Only limited studies highlighted the effectiveness of group assertiveness training among inpatients with schizophrenia. Given the lack of group assertiveness training among patients with schizophrenia, further development of programmes focusing on facilitating assertiveness, self-confidence and social skills among inpatients with chronic schizophrenia is needed. This study used a prospective, randomized, single-blinded, parallel-group design. This study employed a prospective, randomized, parallel-group design. Seventy-four patients were randomly assigned to experimental group receiving 12 sessions of assertiveness training, or a supportive control group. Data collection took place for the period of June 2009-July 2010. Among patients with chronic schizophrenia, assertiveness, levels of social anxiety and satisfaction with interpersonal communication significantly improved immediately after the intervention and at the 3-month follow-up in the intervention group. The results of a generalized estimating equation (GEE) indicated that: (1) assertiveness significantly improved from pre- to postintervention and was maintained until the follow-up; (2) anxiety regarding social interactions significantly decreased after assertiveness training; and (3) satisfaction with interpersonal communication slightly improved after the 12-session intervention and at the 3-month follow-up. Assertivenss training is a non-invasive and inexpensive therapy that appears to improve assertiveness, social anxiety and interpersonal communication among inpatients with chronic schizophrenia. These findings may provide a reference guide to clinical nurses for developing assertiveness-training protocols. © 2013 Blackwell Publishing Ltd.

  18. Topical symphytum herb concentrate cream against myalgia: a randomized controlled double-blind clinical study.

    Science.gov (United States)

    Kucera, Miroslav; Barna, Milos; Horàcek, Ondrej; Kàlal, Jan; Kucera, Alexander; Hladìkova, Marie

    2005-01-01

    The effectiveness and tolerability of the topical Symphytum product Traumaplant (Harras Pharma Curarina, München, Germany) (10% active ingredient of a 2.5:1 aqueous-ethanolic pressed concentrate of freshly harvested, cultivated comfrey herb [Symphytum uplandicum Nyman], corresponding to 25 g of fresh herb per 100 g of cream) in the treatment of patients with myalgia (n=104) were tested against a 1% reference product (corresponding to 2.5 g of fresh comfrey herb in 100 g of cream; n=111). The primary efficacy parameter in this double-blind, reference- controlled, randomized, multicenter study of 215 patients with pain in the lower and upper back was pain in motion, assessed with the aid of a visual analogue scale. Secondary efficacy parameters included pain at rest, pain on palpation, and functional impairment. With high concentrations of the treatment product, amelioration of pain on active motion (P<5 x 10 -9 ), pain at rest (P<.001), and pain on palpation (P=5 x 10 -5 ) was significantly more pronounced than that attained with the reference product and was clinically highly relevant. A number needed to treat of 3.2 was calculated from the study results. Global efficacy was significantly better (P=1 x 10 -8 ) and onset of effects was faster (P=4 x 10 -7 ) with the high-concentration product. Tolerability of the highly concentrated study product was good to excellent in all patients. Study results confirm the known anti-inflammatory and analgesic effects of topical (Symphytum cream. As a new finding, applicability in certain forms of back pain can be concluded.

  19. Mike's Educational Program: Long Island, New York. Case Study. Social Relationships of Children and Adolescents with Deaf-Blindness Research Project.

    Science.gov (United States)

    Mar, Harvey H.; Sall, Nancy

    This case study describes the educational history and current program of Mike, a mainstreamed sixth-grader with deaf-blindness. It addresses the boy's successes and the ongoing challenges faced by his family, his educational team, and his peers. Background information notes his diagnosis of total blindness and moderate to severe hearing loss, his…

  20. Lysine clonixinate versus dipyrone (metamizole) for the acute treatment of severe migraine attacks: a single-blind, randomized study.

    Science.gov (United States)

    Krymchantowski, Abouch Valenty; Carneiro, Henrique; Barbosa, Jackeline; Jevoux, Carla

    2008-06-01

    Nonsteroidal anti-inflammatory drugs (NSAID) are effective to treat migraine attacks. Lysine clonixinate (LC) and dipyrone (metamizol) have been proven effective to treat acute migraine. The aim of this study was to evaluate the efficacy and tolerability of the intravenous formulations of LC and dipyrone in the treatment of severe migraine attacks. Thirty patients (28 women, 2 men), aged 18 to 48 years with migraine according the International Headache Society (IHS) (2004) were studied. The patients were randomized into 2 groups when presenting to an emergency department with a severe migraine attack. The study was single-blind. Headache intensity, nausea, photophobia and side effects were evaluated at 0, 30, 60 and 90 minutes after the drug administration. Rectal indomethacin as rescue medication (RM) was available after 2 hours and its use compared between groups. All patients completed the study. At 30 minutes, 0% of the dipyrone group 13% of the LC group were pain free (p=0.46). At 60 and 90 minutes, 2 (13%) and 5 (33%) patients from the dipyrone group and 11 (73%) and 13 (86.7%) patients from the LC group were pain free (p<0.001). At 60 minutes, significantly more patients from the LC group were nausea-free (p<0.001). Regarding photophobia, there were no differences between groups at 60 minutes (p=0.11). The use of RM at 2 hours did not differ among groups (p=0.50). Pain in the site of the injection was reported by more patients of the LC group compared to the dipyrone group (p<0.0001). LC is significantly superior to dipyrone in treating severe migraine attacks. LC promotes significantly more burning at the site of the injection.

  1. Influence of selenium supplementation on patients with inflammation: A pilot double blind randomized study.

    Science.gov (United States)

    Freitas, Renata Germano Borges de Oliveira Nascimento; Nogueira, Roberto José Negrão; Cozzolino, Silvia Maria Franciscato; Vasques, Ana Carolina Junqueira; Hessel, Gabriel

    2017-09-01

    The aim of the study was to analyze the effect of selenium supplementation on patients with inflammation receiving PN. This double-blind randomized study included 20 hospitalized patients experiencing an inflammatory process while being fed by PN, who were monitored in three stages: first 72 h (0), day 7 (1), and day 14 (2) of PN. The supplemented patients group (G+S) received 60 μg/d (0.75 μmol) of selenium as selenious acid which was added to the PN bag. The nonsupplemented group (G-S) did not receive selenium. The concentration range of 84 to 100 μg/L (1.07-1.27 μmol/L) was used as a reference of plasma selenium. The study included 20 patients (8 G+S and 12 G-S) mainly diagnosed with cancer and/or sepsis. Most of them were hospitalized in the intensive care unit and were receiving PN for clinical reasons. Plasma selenium was greater in the G+S than in the G-S (P = 0.05) in two stages (0 and 1). Since the start of assessment, C-reactive protein (CRP) levels were elevated; however, there was no statistical difference in CRP values between groups (P > 0.05). There was no significant change of glutathione peroxidase over time or between groups (P > 0.05). The selenium concentration was greater in the G+S than in the G-S, acting independently from CRP behavior. However, supplementation was not enough to reach the reference values. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. A double-blind study evaluating the long-term safety of varenicline for smoking cessation.

    Science.gov (United States)

    Williams, Kathryn E; Reeves, Karen R; Billing, Clare B; Pennington, Ann M; Gong, Jason

    2007-04-01

    We assessed the safety of long-term varenicline administration for smoking cessation. In this randomized, double-blind, multicenter trial, eligible adult smokers (18-75 years) who smoked an average of > or =10 cigarettes/day were randomized to either varenicline 1 mg twice daily (BID) or placebo for 52 weeks. Subjects made weekly clinic visits until week 8, and then every 4 weeks until week 52, with a follow-up visit at week 53. The target quit date was the morning of the week 1 clinic visit. Brief counseling was provided at each visit, and vital signs, adverse events (AEs), and smoking status were documented. Other laboratory measures were collected at specified visits. A total of 251 subjects were randomized to varenicline and 126 to placebo. Approximately half of the subjects in each arm completed the study (53.8% varenicline; 46.8% placebo). Treatment-emergent AEs were observed in 96.4% of varenicline- and 82.5% of placebo-treated subjects during the study. Common varenicline-associated AEs were nausea (40.2%), abnormal dreams (22.7%), and insomnia (19.1%). Most AEs were considered mild or moderate in intensity. AEs leading to discontinuation of varenicline treatment included nausea (7.6%), insomnia (3.2%), and abnormal dreams (2.4%). A single varenicline-related serious AE, bilateral subcapsular cataracts, was observed. At week 52, 7-day point prevalence abstinence rates were 36.7% (varenicline) and 7.9% (placebo). Varenicline 1 mg BID can be safely administered for up to 1 year. Varenicline was also a more effective smoking cessation aid than placebo throughout the study, supporting both its short- (12-week) and long-term (52-week) efficacy.

  3. Shear Wave Elastography (SWE) for Monitoring of Treatment of Tendinopathies: A Double-blinded, Longitudinal Clinical Study.

    Science.gov (United States)

    Dirrichs, Timm; Quack, Valentin; Gatz, Matthias; Tingart, Markus; Rath, Björn; Betsch, Marcel; Kuhl, Christiane K; Schrading, Simone

    2018-03-01

    We aimed to investigate the diagnostic accuracy with which shear wave elastography (SWE) can be used to monitor response to treatment of tendinopathies, and to compare it to conventional ultrasound (US)-imaging methods (B-mode US (B-US) and power Doppler US (PD-US)). A prospective Institutional Review Board-approved longitudinal study on 35 patients with 47 symptomatic tendons (17 Achilles-, 15 patellar-, and 15 humeral-epicondylar) who underwent standardized multimodal US and standardized clinical assessment before and after 6 months of treatment (tailored stretching exercise, sport break, and local Polidocanol) was carried out. All US studies were performed by radiologists blinded to the clinical symptoms on both tendon sides to avoid biased interpretations, by B-US, PD-US, and SWE, conducted in the same order, using a high-resolution linear 15 MHz probe (Aixplorer). Orthopedic surgeons who were in turn blinded to US imaging results used established orthopedic scores (Victorian Institute of Sports Assessment questionnaire for Achilles, Victorian Institute of Sports Assessment questionnaire for patellar tendons, and Disability Arm Shoulder Hand scoring system) to rate presence, degree, and possible resolution of symptoms. We analyzed the diagnostic accuracy with which the different US imaging methods were able to detect symptomatic tendons at baseline as well as treatment effects, with orthopedic scores serving as reference standard. B-US, PD-US, and SWE detected symptomatic tendons with a sensitivity of 66% (31 of 47), 72% (34 of 47), and 87.5% (41 of 47), respectively. Positive predictive value was 0.67 for B-US, 0.87 for PD-US, and 1 for SWE. After treatment, clinical scores improved in 68% (32 of 47) of tendons. Treatment effects were observable by B-US, PD-US, and SWE with a sensitivity of 3.1% (1 of 32), 28.1% (9 of 32), and 81.3% (26 of 32), respectively. B-US was false-positive in 68.8% (20 of 32), PD-US in 46.9% (15 of 32), and SWE in 12.5% (4 of 32

  4. A comparative study of map use

    DEFF Research Database (Denmark)

    Bouvin, Niels Olof; Brodersen, Ann Christina; Bødker, Susanne

    2006-01-01

    We present a study comparing the handling of three kinds of maps, each on a physical device: a paper map, a tablet-PC based map, and a cellular phone based one. Six groups of users were asked to locate eight landmarks, looking out a window, and using a particular map. We have begun analyzing video...

  5. A comparative study of microbiological and physicochemical ...

    African Journals Online (AJOL)

    A comparative study of microbiological and physicochemical characteristics of water distributed from two water treatment plants in Rwanda. ... Thus, as recommendation to WASAC authority, there is a need for improvement in the water management strategy for better water quality especially along the distribution network.

  6. Comparative study of quantum anharmonic potentials

    International Nuclear Information System (INIS)

    Amore, Paolo; Aranda, Alfredo; De Pace, Arturo; Lopez, Jorge A.

    2004-01-01

    We perform a study of various anharmonic potentials using a recently developed method. We calculate both the wave functions and the energy eigenvalues for the ground and first excited states of the quartic, sextic and octic potentials with high precision, comparing the results with other techniques available in the literature

  7. Comparative study of potato cultivation through micropropagation ...

    African Journals Online (AJOL)

    sonu

    Comparative study of potato cultivation through micropropagation and conventional farming methods .... and Murate potash were used as fertilizer source of nitrogen, phosphorus and potassium, respectively (Table 1) ..... through Tissue culture- Application and Feasibility. U.S.D.A.,. Beltsville. Agric. Res. Sci. Educ. Admin.

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

    OpenAIRE

    Chetna Deep Lamba; Praveen Oberai; Raj K Manchanda; Padmalaya Rath; P Hima Bindu; Maya Padmanabhan

    2018-01-01

    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 t...

  9. Causes of childhood blindness in Ghana: results from a blind school survey in Upper West Region, Ghana, and review of the literature.

    Science.gov (United States)

    Huh, Grace J; Simon, Judith; Grace Prakalapakorn, S

    2017-06-13

    Data on childhood blindness in Ghana are limited. The objectives of this study were to determine the major causes of childhood blindness and severe visual impairment (SVI) at Wa Methodist School for the Blind in Northern Ghana, and to compare our results to those published from other studies conducted in Ghana. In this retrospective study, data from an eye screening at Wa Methodist School in November 2014 were coded according to the World Health Organization/Prevention of Blindness standardized reporting methodology. Causes of blindness/SVI were categorized anatomically and etiologically, and were compared to previously published studies. Of 190 students screened, the major anatomical causes of blindness/SVI were corneal scar/phthisis bulbi (CS/PB) (n = 28, 15%) and optic atrophy (n = 23, 12%). The major etiological causes of blindness/SVI were unknown (n = 114, 60%). Eighty-three (44%) students became blind before age one year. Of four published blind school surveys conducted in Ghana, CS/PB was the most common anatomical cause of childhood blindness. Over time, the prevalence of CS/PB within blind schools decreased in the north and increased in the south. Measles-associated visual loss decreased from 52% in 1987 to 10% in 2014 at Wa Methodist School. In a blind school in northern Ghana, CS/PB was the major anatomical cause of childhood blindness/SVI. While CS/PB has been the most common anatomical cause of childhood blindness reported in Ghana, there may be regional changes in its prevalence over time. Being able to identify regional differences may guide future public health strategies to target specific causes.

  10. AMERICAN EDUCATION SYSTEM: A COMPARATIVE STUDY

    OpenAIRE

    BAS, Gökhan

    2016-01-01

    The purpose of this study was to introduce the Education System of the United States of America (USA) and to compare it with the Turkish Education System. The Education System of the United States of America was held from different factors (e.g., education structure, curriculum and instruction, principal selection, educational supervision, special education ,teacher education, finance for education, international examinations, vs.) and these factors were explained under headlines in the study...

  11. Effect of GutGard in the Management of Helicobacter pylori: A Randomized Double Blind Placebo Controlled Study

    Directory of Open Access Journals (Sweden)

    Sreenivasulu Puram

    2013-01-01

    Full Text Available A randomized, double blind placebo controlled study was conducted to evaluate the efficacy of GutGard (root extract of Glycyrrhiza glabra in the management of Helicobacter pylori (H. pylori gastric load. Participants diagnosed with H. pylori infection were randomly assigned to two groups to orally receive 150 mg of GutGard (n=55 or placebo (n=52 once daily for 60 days. H. pylori infection was assessed using 13C-urea breath test (13C-UBT at days 0, 30, and 60. Stool Antigen test (HpSA was also performed on days 0, 30, and 60. Repeated measures of analysis of variance (RMANOVA, chi-square, and Fisher's exact probability tests were used to compare the treatment outcomes. A significant interaction effect between group and time (P=0.00 and significant difference in mean Delta Over Baseline (DOB values between GutGard (n=50 and placebo (n=50 treated groups after intervention period were observed. On day 60, the results of HpSA test were negative in 28 subjects (56% in GutGard treated group whereas in placebo treated group only 2 subjects (4% showed negative response; the difference between the groups was statistically significant. On day 60, the results of 13C-UBT were negative in 24 (48% in GutGard treated group and the difference between the groups was statistically significant. The findings suggest GutGard is effective in the management of H. pylori.

  12. Effect of levodopa in combination with physiotherapy on functional motor recovery after stroke: a prospective, randomised, double-blind study.

    Science.gov (United States)

    Scheidtmann, K; Fries, W; Müller, F; Koenig, E

    2001-09-08

    Functional disability is generally caused by hemiplegia after stroke. Physiotherapy used to be the only way of improving motor function in such patients. However, administration of amphetamines in addition to exercise improves motor recovery in animals, probably by increasing the concentration of norepinephrine in the central nervous system. Our aim was to ascertain whether levodopa could enhance the efficacy of physiotherapy after hemiplegia. We did a prospective, randomised, placebo-controlled, double-blind study in which we enrolled 53 primary stroke patients. For the first 3 weeks patients received single doses of levodopa 100 mg or placebo daily in combination with physiotherapy. For the second 3 weeks patients had only physiotherapy. We quantitatively assessed motor function every week with Rivermead motor assessment (RMA). Six patients were excluded from analyses because of non-neurological complications. Motor recovery was significantly improved after 3 weeks of drug intervention in those on levodopa (RMA improved by 6.4 points) compared with placebo (4.1), and the result was independent of initial degree of impairment (pstroke rehabilitation.

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

    Science.gov (United States)

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

    2006-09-01

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

  14. Weight Maintenance with Litramine (IQP-G-002AS: A 24-Week Double-Blind, Randomized, Placebo-Controlled Study

    Directory of Open Access Journals (Sweden)

    Barbara Grube

    2015-01-01

    Full Text Available Background. Litramine (IQP-G-002AS was shown to be effective and safe for weight loss in overweight and obese subjects. However, long-term effectiveness on maintenance of body weight loss has yet to be ascertained. Objective. To assess effect of Litramine on maintenance of body weight loss. Methods. A double-blind, randomised, placebo-controlled trial on overweight and obese patients was conducted over two sites in Germany for 24 weeks. Subjects with documented previous weight loss of 3% over the last 3–6 months were randomised to groups given either Litramine (3 g/day or a matching placebo. Primary endpoints were difference of mean body weight (kg between baseline and end of study and maintenance of initially lost body weight in verum group, where maintenance is defined as ≤1% weight gain. Results. Subjects who were taking Litramine lost significantly more body weight compared to the subjects taking placebo who gained weight instead (-0.62±1.55 kg versus 1.62±1.48 kg, p<0.001. More importantly, 92% of subjects in Litramine group were able to maintain their body weight after initial weight loss, versus 25% in placebo group. No serious adverse events were reported throughout. Conclusion. Litramine is effective and safe for long-term body weight maintenance. Trial Registration. This trial is registered with Clinicaltrials.gov identifier: NCT01505387.

  15. Prevention of post-spinal hypotension using crystalloid, colloid and ephedrine with three different combinations: A double blind randomized study

    Directory of Open Access Journals (Sweden)

    Mitra Jabalameli

    2012-01-01

    Full Text Available Background: The benefit of prophylactic combination therapy using crystalloid and colloid preload with ephedrine has not been cleared to prevent maternal hypotension after spinal anesthesia at cesarean delivery. This study evaluated the efficacy of three combinational methods to prevent hypotension following spinal anesthesia. Materials and Methods: In this prospective double blind trial, 150 candidates of elective cesarean delivery under spinal anesthesia were randomly allocated to three treatment groups; 1---Ringer′s Lactate (RL solution (15 ml/kg plus Hemaxel (7 ml/kg preload, 2---RL solution (15 ml/kg preload plus ephedrine (15 mg, IV, bolus, 3---Hemaxel (7 ml/kg preload plus ephedrine (15 mg, IV, bolus. Maternal hemodynamic changes during 60 min after spinal injection, nausea/vomiting, and neonatal condition were compared among the groups. Results: The cumulative incidence of hypotension was 44%, 40%, and 46% in groups 1 to 3, respectively. There were not significant differences in supplementary ephedrine requirement among groups which received or among groups which did not receive prophylactic ephedrine. Groups were not different in the incidence of hypertension and nausea or vomiting. There were no significant differences among groups in Apgar scores at 1 or 5 min and umbilical artery PH. Conclusion: Combination of preventive methods decreased the occurrence of hypotension following spinal anesthesia to an acceptable level. Overall, the most effective method was a combination of crystalloid preload with ephedrine.

  16. Iodixanol in cerebral computed tomography: a randomized, double-blind, phase-III, parallel study with iodixanol and iohexol

    International Nuclear Information System (INIS)

    Doerfler, A.; Wanke, I.; Forsting, M.; Fiebach, J.; Sartor, K.; Henseke, P.

    1999-01-01

    Iodixanol is a new nonionic dimer, isotonic with blood at all clinically relevant concentrations. Iodixanol (270 mg I/ml) was compared in a double-blind, randomized, parallel-group, phase-III study to the monomeric nonionic iohexol (300 mg I/ml) for evaluation of safety, tolerability and radiographic efficacy during cerebral CT. One hundred adult patients scheduled to undergo contrast-enhanced cerebral CT were randomly allocated to receive either iodixanol or iohexol. All completed the trial. Safety was evaluated by recording discomfort and other adverse events, tolerance by assessing intensity and incidence of discomfort. Radiographic efficacy was assessed from the diagnostic information and the radiographic density. No serious adverse events occurred. One patient (2 %) in the iodixanol group and one patient (2 %) in the iohexol group experienced a transient reddening at the neck and lower neck-line, respectively. Both contrast agents were well tolerated. One patient (2 %) in the iodixanol group and two patients (4 %) in the iohexol group experienced a sensation of warmth (discomfort) in connection with the injection. No difference between the two contrast media were noted radiographically. This comparison between iodixanol and iohexol showed both contrast media to be safe, well-tolerated and efficacious for use in cerebral CT. (orig.)

  17. Efficacy of tip cryotherapy in the treatment of idiopathic guttate hypomelanosis (IGH): a randomized, controlled, evaluator-blinded study.

    Science.gov (United States)

    Laosakul, Kulwadee; Juntongjin, Premjit

    2017-05-01

    Idiopathic guttate hypomelanosis (IGH) is a common hypopigmentation affecting a large amount of older population. However, there is no standard treatment. Cryotherapy has been reported as an alternative therapy for years; nevertheless, there is no randomized controlled study to determine its efficacy. To evaluate the efficacy and side effects of tip cryotherapy in IGH treatment. Total 101 lesions were included. Forty-three lesions were treated with cryotherapy and 58 lesions were assigned as control. A single session of tip cryotherapy was delivered and remained for 5 s. Colorimeter was used to measure lesional luminosity at baseline and then monthly until 4 months. Digital photographs were evaluated by two blinded dermatologists. In addition, patients' assessments and side effects were assessed. Mean luminosity scale gradually decreased from baseline. Also, the score of the treated lesions has been significantly lower than that of the control lesions since week 8 (p = .005). At the fourth month, dermatologists' assessment revealed that 82.3% of the treated lesions comparing to only 2% of the control showed more than 75% improvement (p cryotherapy appears to be an effective therapy with minimal adverse effect for IGH.

  18. Sad Facial Expressions Increase Choice Blindness

    Directory of Open Access Journals (Sweden)

    Yajie Wang

    2018-01-01

    Full Text Available Previous studies have discovered a fascinating phenomenon known as choice blindness—individuals fail to detect mismatches between the face they choose and the face replaced by the experimenter. Although previous studies have reported a couple of factors that can modulate the magnitude of choice blindness, the potential effect of facial expression on choice blindness has not yet been explored. Using faces with sad and neutral expressions (Experiment 1 and faces with happy and neutral expressions (Experiment 2 in the classic choice blindness paradigm, the present study investigated the effects of facial expressions on choice blindness. The results showed that the detection rate was significantly lower on sad faces than neutral faces, whereas no significant difference was observed between happy faces and neutral faces. The exploratory analysis of verbal reports found that participants who reported less facial features for sad (as compared to neutral expressions also tended to show a lower detection rate of sad (as compared to neutral faces. These findings indicated that sad facial expressions increased choice blindness, which might have resulted from inhibition of further processing of the detailed facial features by the less attractive sad expressions (as compared to neutral expressions.

  19. Ketamine Patient Controlled Analgesia for Acute Pain in Trauma Patients: A Randomized, Active Comparator Controlled, Blinded, Pilot Trial

    Science.gov (United States)

    2017-01-11

    include hypertension , tachycardia, hallucinatory effects, and laryngospasm [7,14]. Notably, ketamine lacks the dose-limiting side effects of central...assessed as a secondary outcome. Median daily pain scores measured via the NRS were also evaluated. All opioid requirements were measured in mg of IV... blood pressure. Conversely, opioid use may lead to reduced heart rate and blood pressure [21]. Studies have shown that ketamine provides analgesia when

  20. Are Branded and Generic Extended-Release Ropinirole Formulations Equally Efficacious? A Rater-Blinded, Switch-Over, Multicenter Study

    Directory of Open Access Journals (Sweden)

    Edit Bosnyák

    2014-01-01

    Full Text Available The aim of this study was to compare the efficacy of the branded and a generic extended-release ropinirole formulation in the treatment of advanced Parkinson’s disease (PD. Of 22 enrolled patients 21 completed the study. A rater blinded to treatment evaluated Unified Parkinson’s Disease Rating Scale, Fahn-Tolosa-Marin Tremor Rating Scale, Nonmotor Symptoms Assessment Scale, and a structured questionnaire on ropinirole side effects. Besides, the patients self-administered EQ-5D, Parkinson’s Disease Sleep Scale (PDSS-2, and Beck Depression Inventories. Branded and generic ropinirole treatment achieved similar scores on all tests measuring severity of motor symptoms (primary endpoint, UPDRS-III: 27.0 versus 28.0 points, P=0.505. Based on patient diaries, the lengths of “good time periods” were comparable (10.5 and 10.0 hours for branded and generic ropinirole, resp., P=0.670. However, generic ropinirole therapy achieved almost 3.0 hours shorter on time without dyskinesia (6.5 versus. 9.5 hours, P<0.05 and 2.5 hours longer on time with slight dyskinesia (3.5 versus. 1.0 hours, P<0.05 than the branded ropinirole did. Except for gastrointestinal problems, nonmotor symptoms were similarly controlled. Patients did not prefer either formulation. Although this study has to be interpreted with limitations, it demonstrated that both generic and branded ropinirole administration can achieve similar control on most symptoms of PD.

  1. Lactobacillus reuteri strain combination in Helicobacter pylori infection: a randomized, double-blind, placebo-controlled study.

    Science.gov (United States)

    Francavilla, Ruggiero; Polimeno, Lorenzo; Demichina, Antonella; Maurogiovanni, Giovanni; Principi, Beatrice; Scaccianoce, Giuseppe; Ierardi, Enzo; Russo, Francesco; Riezzo, Giuseppe; Di Leo, Alfredo; Cavallo, Luciano; Francavilla, Antonio; Versalovic, James

    2014-01-01

    The goals of this study were to investigate the role of a new probiotic preparation (Lactobacillus reuteri DSM 17938 and L. reuteri ATCC PTA 6475) in Helicobacter pylori infection. Specific probiotic strains play a role in H. pylori infection for their ability to decrease bacterial load and gastritis, prevent antibiotic-associated side effects, and increase the eradication rate. This is a prospective, double-blind, randomized, placebo-controlled study in a tertiary care setting. A total of 100 H. pylori-positive naive patients received either L. reuteri combination (2×10 Colony Forming Units) or placebo during a 3-phase study (pre-eradication, eradication, and follow-up). All underwent C urea breath test (C-UBT), blood assessments of gastrin-17 (G17), endoscopy, and the Gastrointestinal Symptom Rating Scale. Eradication was confirmed by C-UBT 8 weeks after the completion of therapy. Fifty patients were allocated in each group. During pre-eradication period, C-UBT δ decreased by 13% in L. reuteri combination as compared with a 4% increase in placebo (-13.2±34% vs. 4.3±27%; Preuteri combination (6.8±2.9 vs. 4±3.1; Preuteri combination as compared with placebo-reported side effects (40.9% vs. 62.8%; Preuteri combination (28% vs. 12%; Preuteri combination and 65.9% in placebo (P=NS). L. reuteri combination increased eradication rate by 9.1% (odds ratio: 1.5). L. reuteri combination alone is able to exert an inhibitory effect on H. pylori growth, and when administered with eradication therapy, it determines a significant reduction in antibiotic-associated side effects. Moreover, L. reuteri combination was able to decrease serum G17 levels and to (not significantly) increase the H. pylori-eradication rate.

  2. Effects of antiseptic mouthwash on resting metabolic rate: A randomized, double-blind, crossover study.

    Science.gov (United States)

    Sundqvist, Michaela L; Lundberg, Jon O; Weitzberg, Eddie

    2016-12-30

    The nitrate-nitrite-nitric oxide pathway has emerged as a significant source of nitric oxide (NO) bioactivity. Dietary intake of inorganic nitrate has a number of cardiovascular effects as well as a decrease in oxygen cost during exercise and a reduction in resting metabolic rate (RMR). Oral bacteria have a key role in bioactivation of inorganic nitrate since they catalyse the conversion of salivary nitrate to the more reactive nitrite anion. Recent studies demonstrate that blood pressure increases with the use of an antiseptic mouthwash, indicating that endogenous, NO-synthase derived nitrate is recycled into nitrite and NO, sufficiently to modulate cardiovascular function. Here we tested if also RMR would be affected by an antiseptic mouthwash. Seventeen healthy normotensive female subjects (23 ± 4 y) participated in this randomized, double-blinded, crossover study. During two 3-day periods separated by 28 days the subjects consumed a diet low in nitrate combined with rinsing their mouth three times daily with a chlorhexidine-containing mouthwash (mouthwash) or placebo mouthwash (placebo) with similar taste but no antiseptic properties. Resting metabolic rate (RMR) was measured by indirect calorimetry and 24 h ambulatory blood pressure recordings were obtained after each intervention together with blood, saliva and urine samples. Treatment with chlorhexidine-containing mouthwash effectively reduced oral conversion of nitrate to nitrite but had no effect on plasma levels of these anions or plasma cGMP. RMR and 24 h ambulatory blood pressure were unaffected by the intervention. We conclude that in young healthy females an antiseptic mouthwash was effective in disrupting oral bacterial nitrate conversion to nitrite, but this was not associated with changes in plasma nitrite, RMR or blood pressure. Copyright © 2016 Elsevier Inc. All rights reserved.

  3. Comparing membranes and bone substitutes in a one-stage procedure for horizontal bone augmentation. A double-blind randomised controlled trial.

    Science.gov (United States)

    Merli, Mauro; Moscatelli, Marco; Mariotti, Giorgia; Pagliaro, Umberto; Raffaelli, Eugenia; Nieri, Michele

    2015-01-01

    The objective of this parallel randomised controlled trial is to compare two bone substitutes and collagen membranes in a one-stage procedure for horizontal bone augmentation: anorganic bovine bone (Bio-Oss) and collagen porcine membranes (Bio-Gide) (BB group) versus a synthetic resorbable bone graft substitute made of pure β-tricalcium phosphate (Ceros TCP) and porcine pericardium collagen membranes (Jason) (CJ group). Patients in need of implant treatment having at least one site with horizontal osseous defects at a private clinic in Rimini (Italy) were included in this study. Patients were randomised to receive either the BB or CJ treatment. Randomisation was computer-generated with allocation concealment by opaque sequentially numbered sealed envelopes. Patients and the outcome assessor were blinded to group assignment. The main outcome measures were implant failure, complications, clinical bone gain at augmented sites, and complete filling of the bone defect. Secondary outcome measures were chair-time, postoperative pain and peri-implant marginal bone level changes. Twenty-five patients with 32 implants were allocated to the BB group and 25 patients with 29 implants to the CJ group. All 50 randomised patients received the treatment as allocated and there were no dropouts up to 6-months post-loading (12 months post-surgery). There were no failures and there were three complications in the BB group and three complications in the CJ group (relative risk: 1.00, 95% CI from 0.22 to 4.49, P = 1.00). The estimated difference between treatments in the vertical defect bone gain was -0.15 mm (95% CI from -0.65 to 0.35, P = 0.5504) favouring the BB group, and the estimated difference between treatments in the horizontal defect bone gain was -0.27 mm (95%CI from -0.73 to 0.19, P = 0.3851) favouring the BB group. There was no difference in the complete filling of the defect (relative risk: 0.88, 95%CI from 0.58 to 1.34, P = 0.7688). No significant differences were

  4. A comparative study of various advanced fusions

    International Nuclear Information System (INIS)

    Momota, H.; Tomita, Y.; Nomura, Y.

    1983-01-01

    For the purpose of comparing the merits and demerits of various advanced fuel cycles, parametric studies of operation conditions are examined. The effects of nuclear elastic collisions and synchrotron radiation are taken into account. It is found that the high-#betta# Catalyzed DD fuel cycle with the transmutation of fusion-produced tritium into helium-3 is most feasible from the point of view of neutron production and tritium handling. The D-D fuel cycles seem to be less attractive compared to the Catalyzed DD. The p- 11 B and p- 6 Li fusion plasmas hardly attain the plasma Q value relevant to reactors. (author)

  5. Dietary nitrate improves vascular function in patients with hypercholesterolemia: a randomized, double-blind, placebo-controlled study123

    Science.gov (United States)

    Velmurugan, Shanti; Gan, Jasmine Ming; Rathod, Krishnaraj S; Khambata, Rayomand S; Ghosh, Suborno M; Hartley, Amy; Van Eijl, Sven; Sagi-Kiss, Virag; Chowdhury, Tahseen A; Curtis, Mike; Kuhnle, Gunter GC; Wade, William G; Ahluwalia, Amrita

    2016-01-01

    Background: The beneficial cardiovascular effects of vegetables may be underpinned by their high inorganic nitrate content. Objective: We sought to examine the effects of a 6-wk once-daily intake of dietary nitrate (nitrate-rich beetroot juice) compared with placebo intake (nitrate-depleted beetroot juice) on vascular and platelet function in untreated hypercholesterolemics. Design: A total of 69 subjects were recruited in this randomized, double-blind, placebo-controlled parallel study. The primary endpoint was the change in vascular function determined with the use of ultrasound flow-mediated dilatation (FMD). Results: Baseline characteristics were similar between the groups, with primary outcome data available for 67 patients. Dietary nitrate resulted in an absolute increase in the FMD response of 1.1% (an ∼24% improvement from baseline) with a worsening of 0.3% in the placebo group (P nitrate group, showing a trend (P = 0.06) to improvement in comparison with the placebo group. Dietary nitrate also caused a small but significant reduction (7.6%) in platelet-monocyte aggregates compared with an increase of 10.1% in the placebo group (P = 0.004), with statistically significant reductions in stimulated (ex vivo) P-selectin expression compared with the placebo group (P nitrate were detected. The composition of the salivary microbiome was altered after the nitrate treatment but not after the placebo treatment (P nitrate treatment; of those taxa present, 2 taxa were responsible for >1% of this change, with the proportions of Rothia mucilaginosa trending to increase and Neisseria flavescens (P nitrate treatment relative to after placebo treatment. Conclusions: Sustained dietary nitrate ingestion improves vascular function in hypercholesterolemic patients. These changes are associated with alterations in the oral microbiome and, in particular, nitrate-reducing genera. Our findings provide additional support for the assessment of the potential of dietary nitrate as a

  6. A double-blind placebo-controlled study of controlled release fluvoxamine for the treatment of generalized social anxiety disorder.

    Science.gov (United States)

    Westenberg, Herman G M; Stein, Dan J; Yang, Haichen; Li, David; Barbato, Luigi M

    2004-02-01

    This was a randomized double-blind placebo-controlled multicenter study to assess the efficacy, safety, and tolerability of fluvoxamine in a controlled release (CR) formulation for treatment of generalized social anxiety disorder (GSAD). A total of 300 subjects with GSAD were randomly assigned to receive either fluvoxamine CR (N = 149) or placebo (N = 151) for 12 weeks. Mean changes from baseline to end point in Liebowitz Social Anxiety Scale (LSAS), Clinical Global Impression Severity of Illness Scale (CGI-S), Sheehan Disability Scale (SDS), as well as the mean end point scores in Clinical Global Impression Improvement Scale (CGI-I) and Patient Global Impression of Improvement Scale (PGI) were compared between the fluvoxamine CR and placebo treatment groups. Arizona Sexual Experience Scale (ASEX), adverse event, and other safety parameters were also assessed. The results demonstrated that fluvoxamine CR was significantly superior to placebo in decreasing LSAS total score (primary measure) starting at week 4. At end point, there was a mean change from baseline of -36.1 +/- 2.7 (37% reduction) in the LSAS total score in the fluvoxamine CR group compared with -27.3 +/- 2.4 (28% reduction) in the placebo group (P = 0.020 for mean change). Fluvoxamine CR was also significantly superior to placebo in SDS, CGI-S, CGI-I at end point (secondary measures). When compared with placebo, fluvoxamine CR did not cause any significant weight gain or clinically significant sexual dysfunction as measured by ASEX. In summary, fluvoxamine CR is an efficacious, safe, and well-tolerated treatment of generalized social anxiety disorder.

  7. 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

    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...

  8. A Double-Blind Gastroscopic Study of a Bismuth-Peptide Complex ...

    African Journals Online (AJOL)

    Forty courses of treatment with bicitropeptide (BCP) were administered to 30 patients with gastric ulcers, in a double-blind crossover trial. Healing was judged gastro- scopically after 4 weeks, at which time 79% of ulcers had healed on BCP and 35% on placebo (P

  9. A randomized, double-blind, placebo-controlled crossover study of ...

    African Journals Online (AJOL)

    Erectile dysfunction (ED) is one of the major health concerns affects the quality of life among Thai male. The treatment of ED by the first-line drugs is limited to a certain group of patients due to their side effects and costs. Alternative medicine can be beneficial for the treatment of ED. This is a randomized, double-blind, ...

  10. On the language of space: Neurocognitive studies in blind and sighted individuals

    NARCIS (Netherlands)

    Struiksma, M.E.

    2011-01-01

    In 1688 Molyneux asked the question whether a blind man who knew the difference between a sphere and a cube from touch, with his sight restored would be able to distinguish between them based on vision. One interpretation of Molyneux’s question is whether spatial representations are

  11. A double-blind gastroscopic study of a Bismuth-peptide complex in ...

    African Journals Online (AJOL)

    Forty courses of treatment with bicitropeptide (BCP) were administered to 30 patients with gastric ulcers, in a double-blind crossover trial. Healing was judged gastroscopically after 4 weeks, at which time 79% of ulcers had healed on BCP and 35% on placebo (P

  12. A comparative study of Averrhoabilimbi extraction method

    Science.gov (United States)

    Zulhaimi, H. I.; Rosli, I. R.; Kasim, K. F.; Akmal, H. Muhammad; Nuradibah, M. A.; Sam, S. T.

    2017-09-01

    In recent year, bioactive compound in plant has become a limelight in the food and pharmaceutical market, leading to research interest to implement effective technologies for extracting bioactive substance. Therefore, this study is focusing on extraction of Averrhoabilimbi by different extraction technique namely, maceration and ultrasound-assisted extraction. Fewplant partsof Averrhoabilimbiweretaken as extraction samples which are fruits, leaves and twig. Different solvents such as methanol, ethanol and distilled water were utilized in the process. Fruit extractsresult in highest extraction yield compared to other plant parts. Ethanol and distilled water have significant role compared to methanol in all parts and both extraction technique. The result also shows that ultrasound-assisted extraction gave comparable result with maceration. Besides, the shorter period on extraction process gives useful in term of implementation to industries.

  13. Environmental Comparative Risk Assessment: A Case Study

    International Nuclear Information System (INIS)

    Ali, M.M.

    2007-01-01

    Health and environmental impacts associated with energy production and industrial activities as well as food production and agricultural activities have had great concern in the last decades. Early activities emerged in late 80s of the last century through an Inter- Agency project (lAEA, UNDY, WHO, ... ) on the comparative risk assessment from energy systems and industrial complexes. A work-shop on Risk Assessment and Management in large industrial areas was held in Alexandria Egypt on 20-33 Det 1993, sponsored by IAEA. Several conferences, experts work groups and workshops were held there of Recent trends in determining risks are: 1. Use of probabilistic risk assessment approach to identify hazardous activities and accident scenario. 2. development of data base on failure probabilities and appropriate physical models. 3. Development of related directives and regulations and criteria Comparative risk assessment case study as a tool for comparing risk is emphasized Criteria of exposure to human and ecological risks are addressed

  14. Triple blind intervention field trial to compare the outcome parameters of the preventive package being administered by community animal health workers

    International Nuclear Information System (INIS)

    Nazir, F.; Khan, M.A.; Mahmood, A.; Rahman, Z.U.

    2009-01-01

    A randomized triple blind intervention field/community trial was conducted to compare different outcome parameters like morbidity rate, mortality rate, conception rate, prophylactic/ therapeutic efficacy rate and cost benefit ratio in a dairy cluster of district Kasur and Okara where the community based animal health delivery system was being practiced. In a cluster of 30 villages, 15 villages were selected as interventional group comprising of 1101 dairy animals and rest of the 15 villages as non- interventional control (placebo) group comprising of 9513 dairy animals. In the non-interventional group of villages, vaccinations anthelmintic and mineral mixture administration as a package was not practiced by the community animal health workers(CAHWS). In the intervention villages group, the preventive package was administered at the rate ranging from 95 to 100 %. The result with respect to morbidity rate, morality rate, conception rate and cost- benefit ratio was significantly better (P< 0.05) in the interventional group as compared to the non-interventional group. In both the groups the ratio of cattle and buffaloes ranged between 1:2.72 and 1: 2.82. (author)

  15. 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

    2014-04-01

    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). We report on the first single-blind placebo lead-in trial of acamprosate, a drug with putative mechanisms restoring E:I imbalance, in twelve youth with ASD. We conducted a 12-week single-blind, placebo lead-in study of acamprosate in youth age 5-17 years with autistic disorder. Six of nine subjects who received active drug treatment were deemed treatment responders (defined by a score at final visit of "very much improved" or "much improved" on the Clinical Global Impressions Improvement scale) and ≥25% improvement on the Aberrant Behavior Checklist Social Withdrawal subscale. Future larger-scale dose finding studies of acamprosate in ASD may be warranted given this preliminary indication of benefit.

  16. Effects of preoperative magnesium sulphate on post-cesarean pain, a placebo controlled double blind study.

    Directory of Open Access Journals (Sweden)

    Seyed Mohamad Mireskandari

    2015-03-01

    Full Text Available To study the role of preoperative intravenous magnesium sulphate in decreasing post-cesarean pain and opioid requirement during first 24hrs.In a double blind randomized clinical trial, prior to induction of general anesthesia, fifty elective cesarean candidates were randomly assigned to one of the two groups of placebo or magnesium sulfate. After surgery visual analogue scale (VAS and infused morphine by PCA during 24 hrs were recorded. The data were analyzed by mann-Whitney -test, analysis of variance, and student t- test.VAS was significantly lower among patients in the magnesium sulphate group at intervals of 1(st, 6(th & 12(th hours after cesarean section (C/S with the mean scales of (48.9 ± 19.6 VS 74.7 ± 18.4, (42.1 ± 0.9 VS 58.3 ± 16.5 and (25.2 ± 6.1VS 30 ± 8.1 respectively and p-value of <0.001, 0.002 and 0.05 respectively. However at 24 hrs there was no significant difference in VAS with mean VAS scales of 22.6 ± 4.5 VS 23.6 ± 4.9 and p-value of 0.49. The dose of infused Morphine during 24 hrs was significantly less in the magnesium sulphate group than the placebo group with the means of 4.36 ± 1.4 VS 7.02 ± 1.9 mg respectively (p < 0.001.Administration of bolus 50 mg/kg magnesium sulphate prior to induction of general anesthesia may significantly decreased the morphine requirement during immediate post operative period and can be recommended as one of the modalities of post-operative pain control in the pregnant patients.

  17. Differences in taste between three polyethylene glycol preparations: a randomized double-blind study.

    Science.gov (United States)

    Lam, Tze J; Mulder, Chris Jj; Felt-Bersma, Richelle Jf

    2011-01-01

    Patients suffering from chronic constipation require long-term, regular therapy with laxatives. Literature regarding patient preference and acceptance in polyethylene glycol preparations is scarce. Therefore, this research aimed to identify preference between the three polyethylene glycol 3350, namely Molaxole(®), Movicol(®), and Laxtra Orange(®). Furthermore, taste is one of the most important factors leading to patients' adherence, particularly when the treatment lasts for a long time. In this randomized, cross-over double-blind study, 100 volunteers were recruited by advertisement. The volunteers were invited to taste the preparations and grade the taste using a five-point hedonic scale (extremely poor taste [1] to extremely good taste [5]). The volunteers were then asked to choose the most palatable preparation. One hundred volunteers with a mean age of 35 years (range 20-61) were randomized (76 females). Molaxole(®), Movicol(®), and Laxtra Orange(®) had a mean hedonic score of 2.76 (SD: 0.82), 2.81 (SD: 0.76) and 3.12 (SD: 0.82) respectively. The hedonic taste score for Laxtra Orange(®) was significantly better than Molaxole(®) (P = 0.001) and Movicol(®) (P = 0.001). No difference was found between Molaxole(®) and Movicol(®) (P = 0.61). Molaxole(®) was the most preferred preparation for 19 volunteers (19%), Movicol(®) for 24 volunteers (25%) and Laxtra Orange(®) for 55 volunteers (56%). Two volunteers had no preference. The order in which volunteers tested the preparations had no influence on the taste results. No significant differences in age or gender were observed. Laxtra Orange(®) was most palatable preparation. This may have implications for adherence in patients with chronic constipation.

  18. Blind CT image quality assessment via deep learning strategy: initial study

    Science.gov (United States)

    Li, Sui; He, Ji; Wang, Yongbo; Liao, Yuting; Zeng, Dong; Bian, Zhaoying; Ma, Jianhua

    2018-03-01

    Computed Tomography (CT) is one of the most important medical imaging modality. CT images can be used to assist in the detection and diagnosis of lesions and to facilitate follow-up treatment. However, CT images are vulnerable to noise. Actually, there are two major source intrinsically causing the CT data noise, i.e., the X-ray photo statistics and the electronic noise background. Therefore, it is necessary to doing image quality assessment (IQA) in CT imaging before diagnosis and treatment. Most of existing CT images IQA methods are based on human observer study. However, these methods are impractical in clinical for their complex and time-consuming. In this paper, we presented a blind CT image quality assessment via deep learning strategy. A database of 1500 CT images is constructed, containing 300 high-quality images and 1200 corresponding noisy images. Specifically, the high-quality images were used to simulate the corresponding noisy images at four different doses. Then, the images are scored by the experienced radiologists by the following attributes: image noise, artifacts, edge and structure, overall image quality, and tumor size and boundary estimation with five-point scale. We trained a network for learning the non-liner map from CT images to subjective evaluation scores. Then, we load the pre-trained model to yield predicted score from the test image. To demonstrate the performance of the deep learning network in IQA, correlation coefficients: Pearson Linear Correlation Coefficient (PLCC) and Spearman Rank Order Correlation Coefficient (SROCC) are utilized. And the experimental result demonstrate that the presented deep learning based IQA strategy can be used in the CT image quality assessment.

  19. Efficacy of the LiSN & Learn auditory training software: randomized blinded controlled study

    Directory of Open Access Journals (Sweden)

    Sharon Cameron

    2012-09-01

    Full Text Available Children with a spatial processing disorder (SPD require a more favorable signal-to-noise ratio in the classroom because they have difficulty perceiving sound source location cues. Previous research has shown that a novel training program - LiSN & Learn - employing spatialized sound, overcomes this deficit. Here we investigate whether improvements in spatial processing ability are specific to the LiSN & Learn training program. Participants were ten children (aged between 6;0 [years;months] and 9;9 with normal peripheral hearing who were diagnosed as having SPD using the Listening in Spatialized Noise - Sentences test (LiSN-S. In a blinded controlled study, the participants were randomly allocated to train with either the LiSN & Learn or another auditory training program - Earobics - for approximately 15 min per day for twelve weeks. There was a significant improvement post-training on the conditions of the LiSN-S that evaluate spatial processing ability for the LiSN & Learn group (P=0.03 to 0.0008, η 2=0.75 to 0.95, n=5, but not for the Earobics group (P=0.5 to 0.7, η 2=0.1 to 0.04, n=5. Results from questionnaires completed by the participants and their parents and teachers revealed improvements in real-world listening performance post-training were greater in the LiSN & Learn group than the Earobics group. LiSN & Learn training improved binaural processing ability in children with SPD, enhancing their ability to understand speech in noise. Exposure to non-spatialized auditory training does not produce similar outcomes, emphasizing the importance of deficit-specific remediation.

  20. Efficacy of the LiSN & Learn Auditory Training Software: randomized blinded controlled study

    Directory of Open Access Journals (Sweden)

    Sharon Cameron

    2012-01-01

    Full Text Available Background: Children with a spatial processing disorder (SPD require a more favorable signal-to-noise ratio in the classroom because they have difficulty perceiving sound source location cues. Previous research has shown that a novel training program - LiSN & Learn - employing spatialized sound, overcomes this deficit. Here we investigate whether improvements in spatial processing ability are specific to the LiSN & Learn training program. Materials and methods: Participants were ten children (aged between 6;0 [years;months] and 9;9 with normal peripheral hearing who were diagnosed as having SPD using the Listening in Spatialized Noise – Sentences Test (LISN-S. In a blinded controlled study, the participants were randomly allocated to train with either the LiSN & Learn or another auditory training program – Earobics - for approximately 15 minutes per day for twelve weeks. Results: There was a significant improvement post-training on the conditions of the LiSN-S that evaluate spatial processing ability for the LiSN & Learn group (p=0.03 to 0.0008, η2=0.75 to 0.95, n=5, but not for the Earobics group (p=0.5 to 0.7, η2=0.1 to 0.04, n=5. Results from questionnaires completed by the participants and their parents and teachers revealed improvements in real-world listening performance post-training were greater in the LiSN & Learn group than the Earobics group. Conclusions: LiSN & Learn training improved binaural processing ability in children with SPD, enhancing their ability to understand speech in noise. Exposure to non-spatialized auditory training does not produce similar outcomes, emphasizing the importance of deficit-specific remediation.

  1. Intravenous dexmedetomidine versus clonidine for prolongation of bupivacaine spinal anesthesia and analgesia: A randomized double-blind study

    Directory of Open Access Journals (Sweden)

    Velayudha Sidda Reddy

    2013-01-01

    Full Text Available Background: Alpha 2 -adrenergic agonists have synergistic action with local anesthetics and may prolong the duration of sensory, motor blockade and postoperative analgesia obtained with spinal anesthesia. Aim: The objectives of this study are to compare and evaluate the efficacy of intravenous dexmedetomidine premedication with clonidine and placebo on spinal blockade duration, postoperative analgesia and sedation in patients undergoing surgery under bupivacaine intrathecal block. Materials and Methods: In this prospective, randomized, double-blind placebo-controlled study, 75 patients of the American Society of Anesthesiologists status I or II, scheduled for orthopedic lower limb surgery under spinal anesthesia, were randomly allocated into three groups of 25 each. Group DE received dexmedetomidine 0.5 μgkg−1 , group CL received clonidine 1.0 μgkg−1 and placebo group PL received 10 ml of normal saline intravenously before subarachnoid anesthesia with 15 mg of 0.5% hyperbaric bupivacaine. Onset time and regression times of sensory and motor blockade, the maximum upper level of sensory blockade were recorded. Duration of postoperative analgesia and sedation scores along with side effects were also recorded. Data was analyzed using analysis of variance or Chi-square test, and the value of P < 0.05 was considered statistically significant. Results: The sensory block level was higher with dexmedetomidine (T4 ± 1 than clonidine (T6 ± 1 or placebo (T6 ± 2. Dexmedetomidine also increased the time (243.35 ± 56.82 min to first postoperative analgesic request compared with clonidine (190.93 ± 42.38 min, P < 0.0001 and placebo (140.75 ± 28.52 min, P < 0.0001. The maximum Ramsay sedation score was greater in the dexmedetomidine group than other two groups (P < 0.0001. Conclusion: Premedication with intravenous dexmedetomidine is better than intravenous clonidine to provide intraoperative sedation and postoperative analgesia during bupivacaine

  2. Intravenous dexmedetomidine versus clonidine for prolongation of bupivacaine spinal anesthesia and analgesia: A randomized double-blind study

    Science.gov (United States)

    Reddy, Velayudha Sidda; Shaik, Nawaz Ahmed; Donthu, Balaji; Reddy Sannala, Venkata Krishna; Jangam, Venkatsiva

    2013-01-01

    Background: Alpha2-adrenergic agonists have synergistic action with local anesthetics and may prolong the duration of sensory, motor blockade and postoperative analgesia obtained with spinal anesthesia. Aim: The objectives of this study are to compare and evaluate the efficacy of intravenous dexmedetomidine premedication with clonidine and placebo on spinal blockade duration, postoperative analgesia and sedation in patients undergoing surgery under bupivacaine intrathecal block. Materials and Methods: In this prospective, randomized, double-blind placebo-controlled study, 75 patients of the American Society of Anesthesiologists status I or II, scheduled for orthopedic lower limb surgery under spinal anesthesia, were randomly allocated into three groups of 25 each. Group DE received dexmedetomidine 0.5 μgkg−1, group CL received clonidine 1.0 μgkg−1 and placebo group PL received 10 ml of normal saline intravenously before subarachnoid anesthesia with 15 mg of 0.5% hyperbaric bupivacaine. Onset time and regression times of sensory and motor blockade, the maximum upper level of sensory blockade were recorded. Duration of postoperative analgesia and sedation scores along with side effects were also recorded. Data was analyzed using analysis of variance or Chi-square test, and the value of P < 0.05 was considered statistically significant. Results: The sensory block level was higher with dexmedetomidine (T4 ± 1) than clonidine (T6 ± 1) or placebo (T6 ± 2). Dexmedetomidine also increased the time (243.35 ± 56.82 min) to first postoperative analgesic request compared with clonidine (190.93 ± 42.38 min, P < 0.0001) and placebo (140.75 ± 28.52 min, P < 0.0001). The maximum Ramsay sedation score was greater in the dexmedetomidine group than other two groups (P < 0.0001). Conclusion: Premedication with intravenous dexmedetomidine is better than intravenous clonidine to provide intraoperative sedation and postoperative analgesia during bupivacaine spinal anesthesia

  3. Effectiveness of different memory training programs on improving hyperphagic behaviors of residents with dementia: a longitudinal single-blind study.

    Science.gov (United States)

    Kao, Chieh-Chun; Lin, Li-Chan; Wu, Shiao-Chi; Lin, Ker-Neng; Liu, Ching-Kuan

    2016-01-01

    Hyperphagia increases eating-associated risks for people with dementia and distress for caregivers. The purpose of this study was to compare the long-term effectiveness of spaced retrieval (SR) training and SR training combined with Montessori activities (SR + M) for improving hyperphagic behaviors of special care unit residents with dementia. The study enrolled patients with dementia suffering from hyperphagia resident in eight institutions and used a cluster-randomized single-blind design, with 46 participants in the SR group, 49 in the SR + M group, and 45 participants in the control group. For these three groups, trained research assistants collected baseline data on hyperphagic behavior, pica, changes in eating habits, short meal frequency, and distress to caregivers. The SR and SR + M groups underwent memory training over a 6-week training period (30 sessions), and a generalized estimating equation was used to compare data of all the three groups of subjects obtained immediately after the training period and at follow-ups 1 month, 3 months, and 6 months later. Results showed that the hyperphagic and pica behaviors of both the SR and SR + M groups were significantly improved (P<0.001) and that the effect lasted for 3 months after training. The improvement of fast eating was significantly superior in the SR + M group than in the SR group. The improvement in distress to caregivers in both intervention groups lasted only until the posttest. Improvement in changes in eating habits of the two groups was not significantly different from that of the control group. SR and SR + M training programs can improve hyperphagic behavior of patients with dementia. The SR + M training program is particularly beneficial for the improvement of rapid eating. Caregivers can choose a suitable memory training program according to the eating problems of their residents.

  4. Homocysteine levels after nitrous oxide anesthesia for living-related donor renal transplantation: a randomized, controlled, double-blind study.

    Science.gov (United States)

    Coskunfirat, N; Hadimioglu, N; Ertug, Z; Akbas, H; Davran, F; Ozdemir, B; Aktas Samur, A; Arici, G

    2015-03-01

    Nitrous oxide anesthesia increases postoperative homocysteine concentrations. Renal transplantation candidates present with higher homocysteine levels than patients with no renal disease. We designed this study to investigate if homocysteine levels are higher in subjects receiving nitrous oxide for renal transplantation compared with subjects undergoing nitrous oxide free anesthesia. Data from 59 patients scheduled for living-related donor renal transplantation surgery were analyzed in this randomized, controlled, blinded, parallel-group, longitudinal trial. Patients were assigned to receive general anesthesia with (flowmeter was set at 2 L/min nitrous oxide and 1 L/min oxygen) or without nitrous oxide (2 L/min air and 1 L/min oxygen). We evaluated levels of total homocysteine and known determinants, including creatinine, folate, vitamin B12, albumin, and lipids. We evaluated factor V and von Willebrand factor (vWF) to determine endothelial dysfunction and creatinine kinase myocardial band (CKMB)-mass, troponin T to show myocardial ischemia preoperatively in the holding area (T1), after discontinuation of anesthetic gases (T2), and 24 hours after induction (T3). Compared with baseline, homocysteine concentrations significantly decreased both in the nitrous oxide (22.3 ± 16.3 vs 11.8 ± 9.9; P nitrous oxide-free groups (21.5 ± 15.3 vs 8.0 ± 5.7; P nitrous oxide group had significantly higher mean plasma homocysteine concentrations than the nitrous oxide-free group (P = .021). The actual homocysteine difference between groups was 3.8 μmol/L. This study shows that homocysteine levels markedly decrease within 24 hours after living-related donor kidney transplantation. Patients receiving nitrous oxide have a lesser reduction, but this finding is unlikely to have a clinical relevance. Copyright © 2015 Elsevier Inc. All rights reserved.

  5. Postabsorption concentration peaks with brand-name and generic verapamil: a double-blind, crossover study in elderly hypertensive patients.

    Science.gov (United States)

    Saseen, J J; Porter, J A; Barnette, D J; Bauman, J L; Zajac, E J; Carter, B L

    1997-06-01

    The pharmacokinetic actions, bioequivalence, and cardiovascular effects of two verapamil products were studied in a randomized, double-blind, crossover study in eight elderly hypertensive patients (median age, 69.5 years; range, 60-79 years) given brand-name or generic immediate-release verapamil in 120-mg twice-daily doses for 14 days. Blood pressures, heart rates, P-R intervals; and serum concentrations of R-/S-verapamil and norverapamil were measured multiple times in patients during the last day of each therapy. Median blood pressure decreased more with generic verapamil than with the brand-name drug, with the largest difference occurring at 0.5 hours (137/74 mmHg versus 144.5/80.5 mmHg; P = 0.05 and 0.091, respectively). Pharmacokinetic parameters were not different for the two products (P generic product, compared with the brand-name drug, had mean area under the concentration-time curve (time 0 to 12 hours) ratios (90% CI) of 1.09 (0.78-1.52), 1.16 (0.87-1.55) and 1.11 (0.81-1.52) for R-, S-, and total verapamil. Seventy concentration peaks (31 with the brand-name drug, 39 with the generic drug) appeared between 8 and 24 hours. Median percentages of increase of these peaks, compared with those of previous concentrations, were 48.3% and 36.3% for brand-name and generic drugs, respectively. Fifty of the 70 peaks (71%) were associated with a stereospecific concentration peak of norverapamil and, temporally, with meals. Our findings suggest that whereas the two verapamil products may not be bioequivalent by Food and Drug Administration criteria, the observed differences in effects were not clinically significant in this elderly population. Multiple concentration peaks after absorption were observed in all patients with both verapamil products and were perhaps related to enterohepatic recirculation.

  6. Everolimus for Previously Treated Advanced Gastric Cancer: Results of the Randomized, Double-Blind, Phase III GRANITE-1 Study

    Science.gov (United States)

    Ohtsu, Atsushi; Ajani, Jaffer A.; Bai, Yu-Xian; Bang, Yung-Jue; Chung, Hyun-Cheol; Pan, Hong-Ming; Sahmoud, Tarek; Shen, Lin; Yeh, Kun-Huei; Chin, Keisho; Muro, Kei; Kim, Yeul Hong; Ferry, David; Tebbutt, Niall C.; Al-Batran, Salah-Eddin; Smith, Heind; Costantini, Chiara; Rizvi, Syed; Lebwohl, David; Van Cutsem, Eric

    2013-01-01

    Purpose The oral mammalian target of rapamycin inhibitor everolimus demonstrated promising efficacy in a phase II study of pretreated advanced gastric cancer. This international, double-blind, phase III study compared everolimus efficacy and safety with that of best supportive care (BSC) in previously treated advanced gastric cancer. Patients and Methods Patients with advanced gastric cancer that progressed after one or two lines of systemic chemotherapy were randomly assigned to everolimus 10 mg/d (assignment schedule: 2:1) or matching placebo, both given with BSC. Randomization was stratified by previous chemotherapy lines (one v two) and region (Asia v rest of the world [ROW]). Treatment continued until disease progression or intolerable toxicity. Primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), overall response rate, and safety. Results Six hundred fifty-six patients (median age, 62.0 years; 73.6% male) were enrolled. Median OS was 5.4 months with everolimus and 4.3 months with placebo (hazard ratio, 0.90; 95% CI, 0.75 to 1.08; P = .124). Median PFS was 1.7 months and 1.4 months in the everolimus and placebo arms, respectively (hazard ratio, 0.66; 95% CI, 0.56 to 0.78). Common grade 3/4 adverse events included anemia, decreased appetite, and fatigue. The safety profile was similar in patients enrolled in Asia versus ROW. Conclusion Compared with BSC, everolimus did not significantly improve overall survival for advanced gastric cancer that progressed after one or two lines of previous systemic chemotherapy. The safety profile observed for everolimus was consistent with that observed for everolimus in other cancers. PMID:24043745

  7. MRA versus digital subtraction angiography in acute subarachnoid haemorrhage: a blinded multireader study of prospectively recruited patients

    International Nuclear Information System (INIS)

    Jaeger, H.R.; Hausmann, O.; Moseley, I.F.; Taylor, W.J.; Mansmann, U.; Partzsch, U.

    2000-01-01

    We performed a blinded multireader study comparing MR angiography (MRA) with digital subtraction angiography (DSA) in 34 prospectively recruited patients who presented with acute subarachnoid haemorrhage (SAH). Two observers independently reviewed the MRA and DSA studies some months after clinical presentation. Presence of an aneurysm was rated on a 4-point confidence scale. Cases in which the initial interpretation of the observers varied were jointly reviewed to reach a consensus opinion. DSA was deliberately chosen not to represent the reference standard and the clinical course and surgical findings were used to explain significant differences between the consensus readings of MRA and DSA. Diagnostic confidence and interobserver agreement were, overall, higher on DSA than on MRA studies (κ DSA = 0.64 versus κ MRA = 0.52 with 95 % CI for Δ = κ DSA -κ MRA [-0.06, 0.31]). With both methods, discrepancies between observers were due to aneurysms overlooked rather than false-positive readings by one observer. Diagnostic accuracy therefore improved when the readings of the two observers were combined, particularly for MRA. Intermethod agreement was only fair and similar for both readers (κ reader 1 = 0.37 versus κ reader 2 = 0.32 with 95 % CI for Δ = κ reader 1 -κ reader 2 [-0.02, 0.11]). Both interobserver and intermethod agreements improved when the data were analysed on a per-study (positive or negative study) rather than on a per-aneurysm basis. Differences in the consensus reading were due to five aneurysms (four single and one multiple) detected only with MRA and five (two single and three multiple) detected only with DSA. MRA and DSA should be regarded as complementary in the investigation of patients with acute SAH. DSA can no longer be regarded as the reference standard. (orig.)

  8. Blind Cat

    Directory of Open Access Journals (Sweden)

    Arka Chattopadhyay

    2015-08-01

    There’s no way to know whether he was blind from birth or blindness was something he had picked up from his fights with other cats. He wasn’t an urban cat. He lived in a little village, soaked in the smell of fish with a river running right beside it. Cats like these have stories of a different kind. The two-storied hotel where he lived had a wooden floor. It stood right on the riverbank and had more than a tilt towards the river, as if deliberately leaning on the water.

  9. A Prospective Study Comparing Ligasure and Open Hemorrhoidectomy

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    Rahimi M

    2011-11-01

    Full Text Available Background: Hemorrhoid is among the most common anorectal diseases and patients with high-grade disease conditions need surgical treatment. Many surgical procedures are available to treat the disease. The aim of this study was to compare the operative time and outcomes, (post-operative pain and complications of LigaSure hemorrhoidectomy with those of the open conventional method.Methods : This randomized single-blind clinical trial included 57 patients (28 in LigaSure and 29 in the open group. The primary variable was the operative time for the excision of a single hemorrhoidal packet. The other variables were post-operative pain measured by morphine doses administered to control pain, scores of visual analogue scale (VAS used to measure pain severity, pain during home stay measured by doses of oral ibuprofen and the mean daily VAS scores, early complications including bleeding and urinary retention, longer-term complications and time to return to work.Results : The demographic data were comparatively the same between the two groups. The average time to excise a single packet of hemorrhoid was significantly shorter in the LigaSure group (8.91 min vs. 17.35 min, P<0.001. Post-operative pain measurements (morphine doses and VAS scores were lower in the LigaSure group, but the differences were not statistically significant (P=0.055 and 0.077, respectively. Complications of the two procedures were also comparable. Neither of the groups returned to work in a shorter time.Conclusion: LigaSure hemorrhoidectomy seems to be a safe method and it can reduce the operative time significantly. It may also have a modest effect on post-operative pain.

  10. Comparative Study of Bancruptcy Prediction Models

    Directory of Open Access Journals (Sweden)

    Isye Arieshanti

    2013-09-01

    Full Text Available Early indication of bancruptcy is important for a company. If companies aware of  potency of their bancruptcy, they can take a preventive action to anticipate the bancruptcy. In order to detect the potency of a bancruptcy, a company can utilize a a model of bancruptcy prediction. The prediction model can be built using a machine learning methods. However, the choice of machine learning methods should be performed carefully. Because the suitability of a model depends on the problem specifically. Therefore, in this paper we perform a comparative study of several machine leaning methods for bancruptcy prediction. According to the comparative study, the performance of several models that based on machine learning methods (k-NN, fuzzy k-NN, SVM, Bagging Nearest Neighbour SVM, Multilayer Perceptron(MLP, Hybrid of MLP + Multiple Linear Regression, it can be showed that fuzzy k-NN method achieve the best performance with accuracy 77.5%

  11. Robust canonical correlations: A comparative study

    OpenAIRE

    Branco, JA; Croux, Christophe; Filzmoser, P; Oliveira, MR

    2005-01-01

    Several approaches for robust canonical correlation analysis will be presented and discussed. A first method is based on the definition of canonical correlation analysis as looking for linear combinations of two sets of variables having maximal (robust) correlation. A second method is based on alternating robust regressions. These methods axe discussed in detail and compared with the more traditional approach to robust canonical correlation via covariance matrix estimates. A simulation study ...

  12. Comparative Study on Water Impact Problem

    OpenAIRE

    Yang, Liang; Yang, Hao; Yan, Shiqiang; Ma, Qingwei; Bihnam, Maria

    2016-01-01

    This paper presents a comparative numerical study for the water impact problems due to dropping of triangular wedges or ship sections. In the numerical investigation, both the dynamic mesh technique and immersed boundary method adopting fixed Cartesian grids have been adopted in order to conform to the motion of the structure. For the former, a multiple-phase solver with the volume of fluid for identifying the free surface is implemented. In the simulation using this method, both the compress...

  13. Paracetamol sharpens reflection and spatial memory: a double-blind randomized controlled study in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Pickering G

    2016-12-01

    Full Text Available Gisèle Pickering,1–3 Nicolas Macian,1,2 Claude Dubray,1–3 Bruno Pereira4 1University Hospital, CHU Clermont-Ferrand, Centre de Pharmacologie Clinique, 2Inserm, CIC 1405, UMR Neurodol 1107, 3Clermont Université, Laboratoire de Pharmacologie, Faculté de médecine, 4CHU de Clermont-Ferrand, Délégation Recherche Clinique Innovation, Clermont-Ferrand, France Background: Acetaminophen (APAP, paracetamol mechanism for analgesic and antipyretic outcomes has been largely addressed, but APAP action on cognitive function has not been studied in humans. Animal studies have suggested an improved cognitive performance but the link with analgesic and antipyretic modes of action is incomplete. This study aims at exploring cognitive tests in healthy volunteers in the context of antinociception and temperature regulation. A double-blind randomized controlled study (NCT01390467 was carried out from May 30, 2011 to July 12, 2011. Methods: Forty healthy volunteers were included and analyzed. Nociceptive thresholds, core temperature (body temperature, and a battery of cognitive tests were recorded before and after oral APAP (2 g or placebo: Information sampling task for predecisional processing, Stockings of Cambridge for spatial memory, reaction time, delayed matching of sample, and pattern recognition memory tests. Analysis of variance for repeated measures adapted to crossover design was performed and a two-tailed type I error was fixed at 5%. Results: APAP improved information sampling task (diminution of the number of errors, latency to open boxes, and increased number of opened boxes; all P<0.05. Spatial planning and working memory initial thinking time were decreased (P=0.04. All other tests were not modified by APAP. APAP had an antinociceptive effect (P<0.01 and body temperature did not change. Conclusion: This study shows for the first time that APAP sharpens decision making and planning strategy in healthy volunteers and that cognitive performance

  14. Estudo comparativo duplamente encoberto entre Sevoflurano Genérico e Sevorane® Estudio comparativo doblemente encubierto entre Sevoflurano genérico y Sevorane® A double-blind comparative study between generic Sevoflurane and SevoraneTM

    Directory of Open Access Journals (Sweden)

    Alfredo Augusto Vieira Portella

    2010-10-01

    types of vials. The differences in physical-chemical properties of those products are due to different manufacturing processes, although they are essentially identical regarding chemical comparison tests. It has been hypothesized that the Sevoflurane molecule could present chemical instability due to the formation of Lewis acids as a consequence of the materials used in the fabrication of the vials and the water content. The objective of this study was to analyze the clinical efficacy of Sevoflurane conditioned in different vials. METHODS: Sixty-four adult patients were randomly divided into two groups. Two Datex-Ohmeda vaporizers, one with only Generic Sevoflurane and the other with SevoraneTM, were used. The study coordinator was responsible for supplying the vaporizers and he did not participated in none anesthetic procedures. The same anesthetic technique and monitoring (ECG, HR, SpO2, P ET CO2, BIS, SEF, TOF, % INSP, % EXP, SBP, and DBP were used in both groups. RESULTS: During anesthesia, differences were not observed between both groups. A statistically significant difference was observed in the time between the interruption of Sevoflurane and spontaneous eye opening (13,91 ± 6.39 min in Group II, and 10.34 ± 6.05 min in Group I and the interruption of Sevoflurane and handgrip on verbal command (15.38 ± 6.47 min in Group II, and 11.88 ± 6.60 in Group I. A statistically significance difference was not observed between the interruption of Sevoflurane and the moment that patients achieved an Aldrete- Kroulik index equal or above 8. CONCLUSIONS: during anesthesia a significant difference between both groups was not observed. Although awakening was 3,5 minutes faster in Group I (Generic Sevoflurane, anesthesiologists did not observe any difference in the clinical behavior of patients

  15. Linear pneumatic motors – a comparative study

    Directory of Open Access Journals (Sweden)

    Deaconescu Tudor

    2017-01-01

    Full Text Available The paper presents a comparative study of the performance of single-acting cylinders, diaphragm cylinders and pneumatic muscles, and offers users information that allows the selection of an optimum technical solution. Such a study was necessary, in view of the numerous papers on pneumatic muscle applications found in literature, that assert the superiority of pneumatic muscles over other pneumatic linear motors in relation to quantities like dimensions, mass, developed force or energy-to-mass ratios, however without offering concrete data.

  16. A comparative study of two shovel designs.

    Science.gov (United States)

    Degani, A; Asfour, S S; Waly, S M; Koshy, J G

    1993-10-01

    In the present study a modified shovel design with two perpendicular shafts is presented. This modified, two-shaft shovel was compared with a regular shovel. The modified shovel was evaluated and tested in a controlled laboratory environment using surface electromyography recorded from the lumbar paraspinal muscles. The new shovel design was also tested in a field study using ratings of perceived exertion. The results indicate that there was a significant reduction in EMG values of the lumbar paraspinal muscles and a consistent reduction in perceived exertion ratings while the modified shovel was being used for removing dirt in digging trenches up to 90 cm in depth.

  17. [Nonprocess autism in children: comparative etiopathogenetic study].

    Science.gov (United States)

    Kagan, V E

    1979-01-01

    Etiopathogenesis of the childhood autism syndrome of a non-process nature is discussed on the basis of a comparative study of 156 children aged from 3 to 16 years. In the etiological complex there is a prevalence of early exogenous-organic noxious factors, which is reflected in disturbances of mental divelopment, maturation of the system of hemispheric pair work. The data of follow-up studies and treatment confirm a conclusion about a residual-organic basis in the syndrome of childhood autism.

  18. Effects of sulfur bath on hip osteoarthritis: a randomized, controlled, single-blind, follow-up trial: a pilot study

    Science.gov (United States)

    Kovács, Csaba; Bozsik, Ágnes; Pecze, Mariann; Borbély, Ildikó; Fogarasi, Andrea; Kovács, Lajos; Tefner, Ildikó Katalin; Bender, Tamás

    2016-11-01

    The effects of balneotherapy were evaluated in patients with osteoarthritis of the hip. This randomized, controlled, investigator-blinded study enrolled outpatients with hip osteoarthritis according to ACR criteria. In addition to home exercise therapy, one patient group received balneotherapy for 3 weeks on 15 occasions. The mineral water used in this study is one of the mineral waters with the highest sulfide ion content (13.2 mg/L) in Hungary. The control group received exercise therapy alone. The WOMAC Likert 3.1 index and the EQ-5D quality of life self-administered questionnaire were completed three times during the study: prior to first treatment, at the end of the 3-week treatment course, and 12 weeks later. The main endpoint was achievement of Minimal Clinically Important Improvement (MCII) at 12 weeks, defined as ≥7.9 points in a normalized WOMAC function score. The intention to treat analysis included 20 controls and 21 balneotherapy patients. At 12 weeks, 17 (81 %) balneotherapy group patients had Minimal Clinically Important Improvement and 6 (30 %) of controls ( p = 0.001). Comparing the results of the two groups at the end of treatment, there was a significant difference in the WOMAC stiffness score only, whereas after 12 weeks, the WOMAC pain, stiffness, function, and total scores also showed a significant difference in favor of the balneotherapy group. The difference between the two groups was significant after 12 weeks in point of EQVAS score, too. The results of our study suggest that the combination of balneotherapy and exercise therapy achieves more sustained improvement of joint function and decreases in pain than exercise therapy alone.

  19. Effectiveness of balneotherapy in chronic low back pain -- a randomized single-blind controlled follow-up study.

    Science.gov (United States)

    Balogh, Zoltán; Ordögh, József; Gász, Attila; Német, László; Bender, Tamás

    2005-08-01

    Balneotherapy, a domain of medical science, focuses on utilizing the beneficial effects of medicinal waters. Low back pain is among the most prevalent musculoskeletal disorders affecting a large proportion of the population during their lifetime. Although small in number, all controlled studies published on this subject have demonstrated the benefits of balneotherapy. This present study was undertaken to compare the effects of hydrotherapy with mineral water vs. tap water on low back pain. A single-blind clinical study was carried out to appraise the therapeutic efficacy of reduced sulphurous water on 60 patients with low back pain. 30 subjects took baths in reduced sulphurous mineral water, whereas the other 30 patients used modified tap water of matching odor. Parameters determined at baseline, after balneo-/hydrotherapy, and at the end of the 3-month follow-up period included the results of the Visual Analogue Scale (VAS) score, the modified Oswestry index, mobility of the spine, antalgic posture, tenderness of the paravertebral muscles on palpation, the dose requirements for analgesics, and the efficacy assessed by the investigators and by the patients. Bathing in mineral water resulted in a statistically significant improvement. This was reflected by the VAS (p balneotherapy. By contrast, hydrotherapy with tap water resulted only in the temporary improvement of just a single parameter: the VAS score improved significantly (p Balneotherapy in itself can alleviate low back pain. As demonstrated by this study, the analgesic efficacy and improvement of mobility accomplished by the use of mineral water is significantly superior to that afforded by hydrotherapy with tap water. Our results clearly establish the beneficial effects of mineral water. Moreover, it is a valuable adjunct to other forms of physical treatment as well as to pharmacotherapy.

  20. Clonidine as an adjunct to intravenous regional anesthesia: A randomized, double-blind, placebo-controlled dose ranging study

    Directory of Open Access Journals (Sweden)

    Clarence S Ivie

    2011-01-01

    Full Text Available Background : The addition of clonidine to lidocaine intravenous regional anesthesia (IVRA has been previously reported to improve postoperative analgesia in patients undergoing upper extremity surgery. Our objective was to perform a dose ranging study in order to determine the optimal dose of clonidine used with lidocaine in IVRA. Design & Setting : We performed a double-blinded randomized placebo-controlled study with 60 patients scheduled for elective endoscopic carpal tunnel release under IVRA with 50 ml lidocaine 0.5%. University-affiliated outpatient surgery center. Data collected in operating rooms, recovery room, and by telephone after discharge from surgery center. Materials & Methods : Sixty adult ASA I or II patients undergoing outpatient endoscopic carpal tunnel release under intravenous regional anesthesia.Patients were randomized into five study groups receiving different doses of clonidine in addition to 50 ml 0.5% lidocaine in their IVRA. Group A received 0 mcg/kg, group B 0.25 mcg/kg, group C 0.5 mcg/kg, group D 1.0 mcg/kg and group E 1.5 mcg/kg of clonidine.Intraoperative fentanyl, recovery room pain scores, time to first postsurgical analgesic, total numb