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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 ... efficacy over placebo (p< 0.002) however no difference was noted when compared to salbutamol ... suggesting benefit from use of natural demulcents such as honey ... was, how it affected the child's and the parents' sleep.

  2. Underwater Acoustic Source Localisation Among Blind and Sighted Scuba Divers: Comparative study

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    Jacopo Cambi

    2017-06-01

    Full Text Available Objectives: Many blind individuals demonstrate enhanced auditory spatial discrimination or localisation of sound sources in comparison to sighted subjects. However, this hypothesis has not yet been confirmed with regards to underwater spatial localisation. This study therefore aimed to investigate underwater acoustic source localisation among blind and sighted scuba divers. Methods: This study took place between February and June 2015 in Elba, Italy, and involved two experimental groups of divers with either acquired (n = 20 or congenital (n = 10 blindness and a control group of 30 sighted divers. Each subject took part in five attempts at an under-water acoustic source localisation task, in which the divers were requested to swim to the source of a sound originating from one of 24 potential locations. The control group had their sight obscured during the task. Results: The congenitally blind divers demonstrated significantly better underwater sound localisation compared to the control group or those with acquired blindness (P = 0.0007. In addition, there was a significant correlation between years of blindness and underwater sound localisation (P <0.0001. Conclusion: Congenital blindness was found to positively affect the ability of a diver to recognise the source of a sound in an underwater environment. As the correct localisation of sounds underwater may help individuals to avoid imminent danger, divers should perform sound localisation tests during training sessions.

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

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    Pritesh Hariprasad Gandhi

    2013-01-01

    Full Text Available 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: 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. Materials and Methods: 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. Observations / Results: 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. Conclusion: 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. Randomized, double-blind, comparative study of oral metronidazole and tinidazole in treatment of bacterial vaginosis

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    Raja, Indu M.; Asha Basavareddy; Deepali Mukherjee; Bikash Ranjan Meher

    2016-01-01

    Objective: To compare the efficacy and tolerability of oral metronidazole and tinidazole in patients with bacterial vaginosis (BV) using Amsel's criteria. Patients and Methods: This was a randomized double-blind study, conducted by the Departments of Pharmacology and Gynecology of a tertiary care teaching hospital. Patients diagnosed with BV received either tablet metronidazole 500 mg twice daily for 5 days or tablet tinidazole 500 mg once daily + one placebo for 5 days and instructed to come...

  5. Comparative study on preventing avoidable blindness in China and in Nepal

    Institute of Scientific and Technical Information of China (English)

    Lin Yan

    2007-01-01

    Background "Vision 2020" was initiated in 1999 and many relevant activities are ongoing, but little information is available on what it has achieved and what constraints it faces. It is not yet clear if funding is the most important constraint. Nepal is one of the underdeveloped countries, but an advanced country in preventing avoidable blindness.The aim of this study was to compare the situation in China and in Nepal in prevention of avoidable blindness.Methods Data from literature review and a field visit were combined. All statistical analyses were carried out with SPSS Version 11.5. The chi-square test was used for comparisons involving categorical variables.Results The blindness rate is higher in Nepal than that in China (P<0.05). The average number of cataract operations performed by one ophthalmologist is much lower in China than in Nepal. The cataract surgical rate (CSR) is much lower in China than in Nepal (P<0.001). High cost of the surgery and inadequate qualifications of human resources were found in China. Cataract surgical outcome in China compared well with international standards.Conclusions Progress towards the "Vision 2020" target in China is much slower than that in Nepal. Further attention to address this issue is urgently needed.

  6. Fractional Carbon Dioxide Laser for Keratosis Pilaris: A Single-Blind, Randomized, Comparative Study

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    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.

  7. Randomized, double-blind, comparative study of oral metronidazole and tinidazole in treatment of bacterial vaginosis.

    Science.gov (United States)

    Raja, Indu M; Basavareddy, Asha; Mukherjee, Deepali; Meher, Bikash Ranjan

    2016-01-01

    To compare the efficacy and tolerability of oral metronidazole and tinidazole in patients with bacterial vaginosis (BV) using Amsel's criteria. This was a randomized double-blind study, conducted by the Departments of Pharmacology and Gynecology of a tertiary care teaching hospital. Patients diagnosed with BV received either tablet metronidazole 500 mg twice daily for 5 days or tablet tinidazole 500 mg once daily + one placebo for 5 days and instructed to come for follow-up at the 1(st) week and 4(th) week. They were categorized as cured, partially cured, and not cured based on Amsel's criteria at the end of the study and compared between two groups using Chi-square test. A total 120 women were enrolled in the study, of which 114 completed the study. The treatment arms were comparable. The cure rate with low-dose tinidazole was significantly more compared to metronidazole at 4(th) week (P = 0.0013), but not at 1(st) week (P = 0.242). The adverse drug reactions were less with tinidazole compared to metronidazole. Tinidazole at lower dose offers a better efficacy than metronidazole in long-term cure rates and in preventing relapses with better side effect profile.

  8. Rolipram in major depressive disorder: results of a double-blind comparative study with imipramine.

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    Hebenstreit, G F; Fellerer, K; Fichte, K; Fischer, G; Geyer, N; Meya, U; Sastre-y-Hernández, M; Schöny, W; Schratzer, M; Soukop, W

    1989-07-01

    Rolipram improves signal transmission in central noradrenergic neurones at a pre- and postsynaptic level, and is thus a novel approach in antidepressant therapy. In order to prove efficacy, tolerance, and safety, several controlled studies are underway. Results of a randomized double-blind comparative trial versus imipramine involving 64 in-patients with Major Depressive Disorder (DSM III) in six independent centers will be presented and discussed. The chosen biometric model provided evidence that towards the end of the study imipramine was superior to Rolipram. The particular clinical relevance of this difference is discussed. As regards tolerance, nausea emerged as the typical side-effect of Rolipram, whereas imipramine precipitated mainly anticholinergic side-effects.

  9. Randomised double-blind comparative study of dexmedetomidine and tramadol for post-spinal anaesthesia shivering

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    Geeta Mittal

    2014-01-01

    Full Text Available Background and Aims: Dexmedetomidine (α2 adrenergic agonist has been used for prevention of post anaesthesia shivering. Its use for the treatment of post-spinal anaesthesia shivering has not been evaluated. The aim of this study was to evaluate and compare the efficacy, haemodynamic and adverse effects of dexmedetomidine with those of tramadol, when used for control of post-spinal anaesthesia shivering. Methods: A prospective, randomised, and double-blind study was conducted in 50 American Society of Anaesthesiologists Grade I and II patients of either gender, aged between 18 and 65 years, scheduled for various surgical procedures under spinal anaesthesia. The patients were randomised in two groups of 25 patients each to receive either dexmedetomidine 0.5 μg/kg or tramadol 0.5 mg/kg as a slow intravenous bolus. Grade of shivering, onset of shivering, time for cessation of shivering, recurrence, response rate, and adverse effects were observed at scheduled intervals. Unpaired t-test was used for analysing the data. Results: Time taken for cessation of shivering was significantly less with dexmedetomidine when compared to tramadol. Nausea and vomiting was observed only in tramadol group (28% and; 20% respectively. There was not much difference in the sedation profile of both the drugs. Conclusion: We conclude that although both drugs are effective, the time taken for cessation of shivering is less with dexmedetomidine when compared to tramadol. Moreover, dexmedetomidine has negligible adverse effects, whereas tramadol is associated with significant nausea and vomiting.

  10. Analgesic dose range finding of lornoxicam compared to diclofenac. Crossover double blind study in rheumatoid arthritis

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    O. Di Munno

    2011-09-01

    Full Text Available Objective: To evaluate the therapeutic action and safety of lornoxicam, a new non steroidal anti-inflammatory drug, in 2 oral daily dose regimens of 8 and 16 mg in comparison with oral diclofenac 150 mg/day in patients with rheumatoid arthritis. Methods: Double blind double-dummy cross-over, controlled trial. The two treatments were given for ten-day periods, separated by a three-day wash-out interval. Patients of both sexes with classical or definite rheumatoid arthritis according to the A.R.A. criteria were enrolled in the study. Results: Fourteen patients (12F, 2M were admitted, mean age 61.6 years ± 6.7 (±SD, duration of illness 12.7 years ± 11.9. Lornoxicam 8 and 16 mg/day showed a good therapeutic activity, comparable with diclofenac 150 mg/day. Two patients complained adverse events with diclofenac. Conclusions: Lornoxicam 16 mg/day was associated with a more sharp action and a better tolerability than diclofenac in rheumatoid arthritis. The twice a day dosage of lornoxicam revealed to be appropriate.

  11. [Comparative double-blind study of bromazepam versus prazepam in non-psychotic anxiety].

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    Guelfi, J D; Lancrenon, S; Millet, V

    1993-01-01

    The efficacy of bromazepam and prazepam for the different components of anxiety: inhibition, asthenia and somatisation is evaluated in a multi-centric, comparative and randomised study, conducted as double blind and in parallel groups in 159 adult patients showing a manifest anxiety according to the F.D.A. criteria. After a 7 day wash-out period, the patients receive either bromazepam in a 12 mg/d dose or prazepam in a 40 mg/d dose, over 4 weeks (D0-D28), then in a decreasing dose from D28 to D43; follow-up is carried out using the anxious inhibition scale W.P.2, auto-questionnaire A.D.A., the Hamilton anxiety scale and the Tyrer questionnaire (benzodiazepine withdrawal symptoms questionnaire). Patients are evaluated seven times during the study: at day 7 for inclusion, day 0 for randomisation, then day 7 and day 14 for following visits, at day 28 for efficacy and tolerance evaluation, and at day 50 for utilisation and withdrawal evaluation. The major efficacy criteria are the evolution of inhibition, asthenia and somatisation as compounds of anxiety respectively evaluated by W.P.2 scale, asthenic partial score of autoquestionnaire A.D.A. and somatic partial score of Hamilton anxiety scale. The analysis of results don't show any significant difference between the two groups on the evolution of the components asthenia and inhibition. However the evolution of the somatic component clearly makes a significant difference in favour of bromazepam. There is also a significant difference in terms of global anxiolytic action efficacy, in favour of bromazepam.(ABSTRACT TRUNCATED AT 250 WORDS)

  12. Double-blind prospective study comparing two automated sperm analyzers versus manual semen assessment.

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    Lammers, J; Splingart, C; Barrière, P; Jean, M; Fréour, T

    2014-01-01

    Despite controversy regarding its clinical value, male fertility investigation mainly relies on semen analysis. Even though reference guidelines are available, manual sperm analysis still suffers from analytical variability, thus questioning the interest of automated sperm analysis systems. The aim of this study is to compared automated computerized semen analysis systems (SQA-V GOLD and CASA CEROS) to the conventional manual method in terms of accuracy and precision. We included 250 men in this double-blind prospective study. The SQA-V GOLD (Medical Electronic Systems) and CEROS, CASA system (Hamilton Thorne) were compared to the standard manual assessment based on the WHO 5th Edition. The main outcome measures were sperm concentration, total sperm number, total motility, progressive motility, non-progressive motility, morphology, motile sperm concentration (MSC) and progressively motile sperm concentration (PMSC) with the three methods. Statistical analysis of the test results from the automated systems and the manual method demonstrated no significant differences for most of the semen parameters. The Spearman coefficients of rank correlation (rho) for CASA and the SQA-V GOLD automated systems vs. the manual method were: Sperm concentration (0.95 and 0.95), total sperm number (0.95 and 0.95), MSC (0.94 and 0.96) and PMSC (0.94 and 0.93) correspondingly. Concerning sperm morphology, both automated systems demonstrated high specificity (Sp) and negative predictive values (NPV), despite significantly different medians (CASA: 83.7 % for Sp and 95.2 % for NPV, SQA-V: 97.9 % for Sp and 92.5 %). The highest precision (lowest 95 % confidence interval for duplicate tests) for all semen variables was found in the SQA-V GOLD. The advantages of using automated semen analysers are: Standardization, speed (lower turnaround time), precision, reduced potential for human error, automated data recording and less need for highly skilled professionals to run the systems. The

  13. Double-blind, comparative study of milnacipran and paroxetine in Japanese patients with major depression

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    Kamijima K

    2013-04-01

    Full Text Available Kunitoshi Kamijima,1 Shinji Hashimoto,2 Eiichi Nagayoshi,2 Tsukasa Koyama3 1International University of Health and Welfare, Tochigi, 2Asahi-kasei Pharma Corporation, Tokyo, 3Ohyachi Hospital, Sapporo, Japan Background and methods: A double-blind, parallel-group, controlled study was performed to investigate if milnacipran was noninferior to paroxetine in terms of improvement in symptoms of depression in Japanese patients with major depressive disorders in a fixed-dose design. The efficacy and safety of milnacipran 200 mg/day were also assessed in comparison with those at the standard dose of 100 mg/day. Results: Changes in 17-item Hamilton depression rating scale (HAM-D total score (mean ± standard deviation for group M1 (milnacipran 100 mg/day, group M2 (milnacipran 200 mg/day, and group PX (paroxetine 30 or 40 mg/day were -12.9 ± 5.8, -12.8 ± 6.1, and -13.1 ± 6.2, respectively, and the estimated differences in total score for group PX (Dunnett's 95% simultaneous confidence interval were 0.1 (-1.1 to 1.3 for group M1 and 0.3 (-0.9 to 1.5 for group M2. The noninferiority of groups M1 and M2 to group PX was thus confirmed, because the upper confidence limit of differences between groups M1 and PX and between groups M2 and PX was less than 2.0. The estimated mean difference of change in HAM-D total score (95% confidence interval between groups M2 and M1 was 0.2 (-0.9 to 1.2, indicating a comparable change in total score for both groups. The incidence of treatment-related adverse events was 71.7% for group M1, 68.8% for group M2, and 69.3% for group PX, indicating no significant difference between the three groups. Conclusion: These results demonstrate that milnacipran 100 mg/day and 200 mg/day is not inferior to paroxetine in terms of efficacy and safety. Keywords: milnacipran, paroxetine, depression, noninferiority, Japan

  14. A double-blind study of the effect on hemostasis of nabumetone (Relafen) compared to placebo.

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    Jennings, M B; Alfieri, D M; Jules, K T; Lesczczynski, C

    2000-01-01

    A double-blind, placebo-controlled clinical trial comparing the effect on hemostasis of nabumetone (Relafen) to placebo in patients who were about to undergo forefoot surgery was performed. Aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) are reported to inhibit platelet cyclooxygenase activity, resulting in altered platelet function and thus potentially enhanced bleeding. Nabumetone has been reported to have no effect on platelet aggregation and bleeding time in normal volunteers and in patients who have undergone knee arthroscopy. After fulfilling the inclusion criteria and after a 1-week washout period (acetaminophen controlled), 15 patients were enrolled in the nabumetone group and 15 patients were randomized in the placebo group. Hemostatic parameters [prothrombin time (PT), partial thromboplastin time (PTT), and Ivy bleeding time (IBT)] were assessed at baseline, visit 2, visit 3, and final visit. No meaningful differences were observed between treatment groups in any of the measured hemostatic parameters. No significant adverse events were reported. There was no significant change from baseline for PT, PTT, and IBT in the nabumetone group (PT, p nabumetone in dosages up to 1000 mg/day can be administered safely in the immediate preoperative period to patients undergoing forefoot surgery.

  15. Iohexol, ioxaglate and iopamidol in coronary angiography. A double-blind comparative study of 300 patients.

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    Soiva, M; Hekali, P; Keto, P; Karumo, J; Salonen, O; Heikkilä, J

    1991-05-01

    A randomized, double-blind study was carried out in 300 consecutive coronary angiography examinations to investigate the clinical safety of three low osmolar contrast media, iohexol 300, ioxaglate 320 and iopamidol 300, and the electrocardiographic changes that occurred with them. The ECG from electrode V5/V6 or AVF and intra-arterial pressure were monitored continuously, and recorded before and after the first contrast injections into the left and right coronary arteries. Of the variables tested, no statistically significant changes occurred in systolic arterial pressure, PR interval or ventricular extrasystole. The QT interval increased in the ioxaglate group (p = 0.001). Heart rate decreased in all groups, but slightly less in the ioxaglate group than in the iopamidol group (p = 0.02). The ST segment depression (mean 0.67m) was more marked in the ioxaglate group than in the other treatment groups (p = 0.0001) during right coronary angiography. The same characteristics, but less marked, were observed during left coronary angiography, the ioxaglate group (mean 0.251mm) differing from the iopamidol group (mean 0.050mm) (p = 0.04). No significant difference in severe adverse reactions were detected between these groups (ioxaglate 1, iopamidol 1). Ioxaglate produced mild side effects (nausea, vomitus, urticaria) in 16% of the patients, the other two contrast agents producing side effects in 1%.

  16. Comparative Evaluation of Neem Mouthwash on Plaque and Gingivitis: A Double-blind Crossover Study.

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    Jalaluddin, Md; Rajasekaran, U B; Paul, Sam; Dhanya, R S; Sudeep, C B; Adarsh, V J

    2017-07-01

    The present study aimed at evaluating the impact of neem-containing mouthwash on plaque and gingivitis. This randomized, double-blinded, crossover clinical trial included 40 participants aged 18 to 35 years with washout period of 1 week between the crossover phases. A total of 20 participants, each randomly allocated into groups I and II, wherein in the first phase, group I was provided with 0.2% chlorhexidine gluconate and group II with 2% neem mouthwash. After the scores were recorded, 1-week time period was given to the participants to carry over the effects of the mouthwashes and then the second phase of the test was performed. The participants were instructed to use the other mouthwash through the second test phase. There was a slight reduction of plaque level in the first phase as well as in the second phase. When comparison was made between the groups, no statistically significant difference was seen. Both the groups showed reduction in the gingival index (GI) scores in the first phase, and there was a statistically significant difference in both groups at baseline and after intervention (0.005 and 0.01 respectively). In the second phase, GI scores were reduced in both groups, but there was a statistically significant difference between the groups only at baseline scores (0.01). In the present study, it has been concluded that neem mouthwash can be used as an alternative to chlorhexidine mouthwash based on the reduced scores in both the groups. Using neem mouthwash in maintaining oral hygiene might have a better impact in prevention as well as pervasiveness of oral diseases as it is cost-effective and easily available.

  17. A comparative study of continuous versus pulsed radiofrequency discectomy for management of low backache: Prospective randomized, double-blind study

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    Jena, Bhagya Ranjan; Paswan, Anil; Singh, Yashpal; Loha, Sandeep; Singh, Anil Prasad; Rastogi, Virendra

    2016-01-01

    Background: Radiofrequency (RF) is a minimally invasive target-selective technique that has been used with success for many years in the treatment of different pathologies, such as low back pain, trigeminal neuralgia, and others. Aim: The aim of this study is to compare different mode of RF - continuous RF (CRF) versus pulsed RF (PRF) along with steroid in the management of low back pain of discogenic origin. Setting and Design: Prospective, randomized, double-blind trial. Materials and Methods: Forty patients with chronic discogenic low back pain were randomized to receive CRF plus intradiscal triamcinolone 40 mg (Group 1) or to receive PRF plus intradiscal triamcinolone 40 mg (Group 2). Outcome measured includes immediate as well as long-term pain relief using visual analog scale, the Oswestry Disability Index and straight leg raising test. Statistical Analysis: The continuous variables were compared by one-way analysis of variance test. Discrete variables were compared by Fisher's exact test/Chi-square test/Student's t-test, whichever appropriate. The value of P PRF was insignificant. Conclusion: CRF with steroid seems to be better for treatment of chronic discogenic low back pain than PRF with steroid. PMID:27746559

  18. AIRWAY ASSESSMENT FOR ANTICIPATION OF DIFFICULT INTUBATION: A DOUBLE BLIND COMPARATIVE STUDY

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    Ushakumary

    2016-05-01

    Full Text Available BACKGROUND AND AIMS In this era of high technology, we still face an ageless problem in anaesthesia – the difficult airway. In 1997, Smarajith Sur Roy of India introduced a new airway index to predict difficult intubation. Aim of the study is to compare the new airway index with modified Mallampati classification and also with Cormack and Lehane grading for predicting intubation difficulty. MATERIALS AND METHODS The study was conducted on 200 patients undergoing various surgeries at a Government Medical College Hospital. Patients between the age group of 15 to 50 years and belonging to American Society of Anaesthesiologist Grade 1 or 2 were selected. Patients were graded using Modified Mallampati classification. Then in hyperextended neck, the distance between the angle of mandible and the midpoint of Symphysis menti (Variable A and the distance between the symphysis menti and the thyroid notch (Variable B were taken in centimetres and A/B ratio calculated. This ratio is the New Airway Index. After premedication and induction of anaesthesia, laryngoscopy was done, Cormack and Lehane grade noted and intubation difficulty assessed. The predictive value of the new airway index was compared against modified Mallampati classification as well as Cormack and Lehane grading and statistical significance assessed. RESULTS The observations made on the calculation of the new airway index were, 1. When the airway index was 1, the intubation was very easy, irrespective of the findings of Mallampati classification and Cormack and Lehane Grade was 1; 2. When the index was 1 to 1.399, the intubation was easier and the laryngoscopic findings were of Cormack and Lehane Grade II; 3. When the index was 1.4 or more, the intubation was difficult and they belonged to Cormack and Lehane Grade III. The predictability was also statistically very significant when compared with modified Mallampati classification (p<0.001 – Chi square test - test for single proportion

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

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    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.

  20. Comparative effect of thymus vulgaris and ibuprofen on primary dysmenorrhea: A triple-blind clinical study.

    Science.gov (United States)

    Salmalian, Hajar; Saghebi, Roshanak; Moghadamnia, Ali Akbar; Bijani, Ali; Faramarzi, Mahbobeh; Nasiri Amiri, Fatemeh; Bakouei, Fatemeh; Behmanesh, Fereshte; Bekhradi, Reza

    2014-01-01

    Dysmenorrhea is one of the most common medical problems in gynecology causing several problems in the personal and social life of women. This study was conducted to compare the effect of thymus vulgaris and ibuprofen on the treatment of primary dysmenorrhea Methods: This clinical study was conducted on 84 students of Babol University of Medical Sciences with primary dysmenorrhea. The students were randomly assigned to three groups receiving thymus vulgaris, ibuprofen and placebo. In all three groups, with the beginning of pain, 200 mg capsules and 25 drops of essential oil were given every 6 hours for two consecutive cycles. Pain intensity used the visual scale before and one hour after each dose for 48 hour after starting medication. The data were collected and analyzed. This study was registered in the Iranian Registry of Clinical Trial (www.irct.ir) with registration number ID: IRCT201101245683N1 RESULTS: The mean age of participants was 20.5±1.8 years. Both thymus vulgaris and ibuprofen were effective to reduce the pain severity of dysmenorrhea. Before treatment, the mean pain intensity in thymus vulgaris, ibuprofen and placebo groups were 6.57±2.02, 5.30±2.23 and 6.18±1.78, respectively and after treatment decreased to 1.21±1.06, 1.48±1.62 and 3.54±2.26, respectively. Reduction of pain severity was not statistically significant between the two medications, however it was significant for each drug compared with placebo (pthymus vulgaris as well as ibuprofen can be effective in reducing the severity of pain and spasm in primary dysmenorrhea.

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

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    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.

  2. Puncture technique and postural postdural puncture headache. A randomised, double-blind study comparing transverse and parallel puncture.

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    Flaatten, H; Thorsen, T; Askeland, B; Finne, M; Rosland, J; Hansen, T; Rønhovde, K; Wisborg, T

    1998-11-01

    This clinical study was conducted in order to investigate the effect of two different orientations of the bevel during dural puncture on development of postural postdural puncture headache (PPDPH). Two hundred and eighteen patients aged 18 to 50 years scheduled for minor non-obstetric surgery using spinal anaesthesia (SA) were included in this randomised, double-blind study. Dural puncture was performed using a 0.42 mm O.D. (27-g) Quincke spinal needle with the orientation of the bevel parallel or transverse relative to the longitudinal axis of the dural cylinder. All patients were blinded with regard to the puncture technique, and so was the anaesthesiologist performing a telephone interview 5 to 7 days postoperatively. The occurrence and duration of headache, backache and other complaints were recorded. Headache was classified as PPDPH or non-PPDPH, and intensity of the headache was registered using a numerical rating scale (NRS) from 0 to 10. Two hundred and twelve patients with a mean age of 35.3 years completed the study, 106 in each group. The two groups were comparable with regard to mean age, sex, local anaesthetics used and surgical procedure performed. Headache occurred in 44 patients postoperatively. PPDPH was diagnosed in 4/106 patients (3.8%) in the parallel group and 24/106 (22.6%) in the transverse group (P < 0.0002). Postoperative backache occurred in 31 and 20 patients (parallel compared to transverse) (NS). Dural puncture with the bevel of the needle transverse to the longitudinal axis of the dural cylinder gave significantly more cases of PPDPH than puncture with the bevel parallel to this axis even when using a 27-g Quincke needle. When using Quincke bevelled needles care must be taken to assure that the orientation of the bevel is parallel to the longitudinal axis of the dural sac.

  3. Double-blind randomized multicenter study comparing Maalox TC tablets and ranitidine in healing of duodenal ulcers.

    Science.gov (United States)

    Hunter, J O; Walker, R J; Crowe, J; Gillies, R R; Gillies, K R; Gough, K R; Lorber, S

    1991-07-01

    The efficacy of ranitidine 150 mg twice daily and Maalox TC three tablets four times daily were compared in patients with endoscopically confirmed duodenal ulcer. Seventy-nine patients were randomly allocated to double-blind, double-dummy treatment, stratified for smokers. Endoscopy was repeated after four weeks. Those unhealed continued treatment for a further two weeks before final endoscopy. Per protocol analysis in 53 patients showed ulcer healing rates at week 4 and at weeks 4 and 6 combined of 78 and 89% on Maalox TC, and of 81 and 91% on ranitidine, respectively. The same analysis gave overall healing rates of 81% in smokers and 100% in nonsmokers, irrespective of treatment. Both treatments provided early ulcer pain relief. Diarrhea was a commoner side effect in patients on Maalox TC. The study showed Maalox TC and ranitidine were equally effective in healing duodenal ulceration.

  4. Risperidone versus pimozide in Tourette's disorder : A comparative double-blind parallel-group study

    NARCIS (Netherlands)

    Bruggeman, R; van der Linden, C.; Buitelaar, JK; Gericke, GS; Hawkridge, SM; Temlett, JA

    2001-01-01

    Background: The treatment of Tourette's disorder with classical neuroleptics is limited by their side effects. Risperidone is a new efficacious antipsychotic with a low propensity for extrapyramidal side effects. To establish risperidone's therapeutic potential in Tourette's disorder, we studied the

  5. Prospective blind comparative clinical study of two point fixation of zygomatic complex fracture using wire and mini plates

    Directory of Open Access Journals (Sweden)

    Gandi Lakshmi N

    2012-03-01

    Full Text Available Abstract Background The zygomatic maxillary complex (ZMC fractures are one of the most frequent injuries of the facial skeleton due to its position and facial contour. Assaults, road traffic accidents and falls are the principal etiologic factors that may cause fractures of zygomatic bone. The different fixation methods are applied to treat the zygomatic bone fractures, with many more classifications which have been described in the literature for the ease of management. The type of the fracture, its severity and associated facial fractures usually interferes the treatment modality. Purpose of study The aim of this paper is to show the results of 18yrs prospective blind comparative study using wire and plate osteosynthesis which needed open reduction and internal fixation involving Type II to Type IV Spissel and Schroll ZMC fractures. Materials and methods Total 80 cases included in the study out of 1780 ZMC cases which were treated using wire and plate osteosynthesis over a period of 18 yrs, involving only Type II to Type IV Spissel and Schroll ZMC fractures. Other types excluded from study to prevent observer bias. All the fixations carried out through Standard Dingman's incision using stainless steel 26 gauze wire and titanium 1.5 mm mini plate system under general anesthesia by single maxillofacial surgeon and evaluated by another maxillofacial surgeon who is blinded for surgical procedure after 2 and 4 wks of follow-up for facial symmetry, wound healing, functional assessment (mouth opening, diplopia, and sensory disturbance. All the data tabulated in Excel software (Microsoft for statistical analysis. P-value calculated to know the Significance of treatment modality in all aspects. Results Result shows no significant p-values indicating both the operating techniques are equally efficient in the surgical management of ZMC fracture. Conclusion Osteosynthesis by mini plates is simple, logical and effective treatment compared to wire

  6. Double-blind, comparative study of cyamemazine vs. bromazepam in the benzodiazepine withdrawal syndrome.

    Science.gov (United States)

    Lemoine, Patrick; Kermadi, Imane; Garcia-Acosta, Stéphanie; Garay, Ricardo P; Dib, Michel

    2006-01-01

    Cyamemazine is an anxiolytic antipsychotic, which reduces ethanol withdrawal symptoms. Here, we investigated if cyamemazine can be also effective as substitute drug to facilitate benzodiazepine withdrawal. A total of 168 patients treated with benzodiazepines for at least 3 months and with a bromazepam (3-6 mg q.d.), followed by 2 weeks of placebo. The primary efficacy variable was the maximal anxiety rebound as measured with the HARS during the 42 days of treatment. No statistically significant differences between treatment groups were found for the extent or incidence of rebound anxiety. Considering all dropout patients as withdrawal failures, after 6 months of follow-up, 56/84 patients in the cyamemazine group (66.7%) and 55/84 patients in the bromazepam group (65.5%) were successfully withdrawn. 28 patients in the cyamemazine group and 18 in the bromazepam group had an adverse event, including anxiety, insomnia, dry mouth and somnolence. No extra-pyramidal symptoms were reported. In conclusion, cyamemazine was comparable to bromazepam in ensuring successful benzodiazepine withdrawal and in controlling the acute benzodiazepine withdrawal syndrome. Cyamemazine may be useful to facilitate benzodiazepine withdrawal in those patients where bromazepam substitution is not appropriate.

  7. [Evaluation of efficacy and tolerability of ioversol in intravenous urography. A comparative double-blind study versus iopamidol].

    Science.gov (United States)

    Joffre, F; Rousseau, H; Aziza, R

    1992-01-01

    The efficacy and safety of Optiray (ioversol), a new low osmolar non-ionic contrast agent were compared with Iopamiron in a double-blind randomized trial for intravenous pyelography. Concerning the diagnostic efficacy, Optiray 300 was equivalent to Iopamiron 370 for identical injection volumes. Significantly less reinjections were necessary with Optiray. Tolerability was found to be excellent, equivalent to the reference product. Optiray was found to be both well tolerated and of satisfactory diagnostic value.

  8. The management of cystic fibrosis with carbocysteine lysine salt: single-blind comparative study with ambroxol hydrochloride.

    Science.gov (United States)

    Caramia, G; Gagliardini, R; Ruffini, E; Osimani, P; Nobilini, A

    1995-01-01

    The effectiveness of carbocysteine lysine salt monohydrate (SCMC-Lys) and ambroxol hydrochloride (ABX) in the management of respiratory impairment was compared in a single-blind, randomized study of 26 cystic fibrosis patients with similar baseline characteristics. Adults received either SCMC-Lys 900 mg or ABX 33 mg three times a day and children under 14 years of age either SCMC-Lys 270 mg three times a day or ABX 10 mg four times a day. All treatments were given orally for 80 days and at the end of this control period both groups showed significant improvement in chest sound score but improvement in cough score was observed only in those receiving SCMC-Lys. Expectorate viscosity and elasticity decreased significantly in both groups. In SCMC-Lys-treated patients paCO2 decreased and paO2 and Hb O2 saturation increased while only paO2 increased significantly in those treated with ABX. An increase in tidal volume, peak expiratory flow values and forced expiratory volume were evident in those receiving SCMC-Lys while significant increases in forced expiratory flow were recorded in those receiving ABX. SCMC-Lys patient's Shwachmann index improved significantly and conversely to the ABX patients. No adverse events were recorded in either treatment group. The study concluded that SCMC-Lys is at least as effective as ABX in improving respiratory function in patients with cystic fibrosis.

  9. [N-acetyl-aspartylglutamic acid eye drops in allergic-type conjuctivitis. Double-blind comparative clinical study].

    Science.gov (United States)

    Bonnet, M; Ducournau, D; Lumbroso, P; Serpin, G

    1985-01-01

    Fifty patients with allergic conjunctivitis were included in a double-blind randomized clinical trial designed to compare the efficiency and tolerance of two antiallergic eye-drops: one containing NAAGA (22 patients), the other one containing disodium Cromoglycate (28 patients). Both treatments were used at a dosage of 1 drop 4 times per day. Ocular symptoms, conjunctivo-corneal signs and the subjective ocular condition assessed by the patients themselves with visual analogue scales, were all significantly improved by both eye-drops during the first month of treatment. Statistical analysis showed that patient ocular condition improved more rapidly with NAAGA eye-drops. In 25 patients (12 in the NAAGA group and 13 in the Cromoglycate group), the study was continued for an additional month according to a cross-over protocol. During the 2nd month of treatment, additional improvement of ocular symptoms and signs were observed with both eye-drops but more markedly in those patients who received NAAGA after Cromoglycate. Ocular tolerance was good for both eye-drops.

  10. [Clinical efficacy of mecobalamin in the treatment of oligozoospermia--results of double-blind comparative clinical study].

    Science.gov (United States)

    Kumamoto, Y; Maruta, H; Ishigami, J; Kamidono, S; Orikasa, S; Kimura, M; Yamanaka, H; Kurihara, H; Koiso, K; Okada, K

    1988-06-01

    The clinical efficacy of mecobalamin in the treatment of male infertility was investigated by means of a multicenter collaborative study with 25 participating institutions. The study was carried out as a double-blind, comparative trial using three administration groups: 6,000 micrograms of mecobalamin per day, 1,500 micrograms of mecobalamin per day and a placebo group for 12 wk. The following results were obtained. 1. The total number of evaluated subjects was 375, consisting of 125 in the 6,000 micrograms/day mecobalamin group, 124 in the 1,500 micrograms/day mecobalamin group and 126 in the placebo group. There were no significant differences among the three administration groups in terms of the patient's background factors. 2. When all of the patients were analyzed, there were no statistically significant differences among the three administration groups in terms of the efficacy in relation to the sperm count or the motility rate. 3. However, it was decided to perform a more detailed analysis of the therapeutic efficacy in patients whose pretreatment sperm counts were 20 x 10(6)/ml or less. The reasons for this decision were two-fold: 1) There was a large degree of fluctuation in patients whose pretreatment sperm counts showed a mean value of more than 20 x 10(6)/ml for two or more determinations, and it was surmised that this fluctuation might have masked any therapeutic effect in those cases. 2) The WHO definition of oligozoospermia was recently decided as a sperm count of 20 x 10(6)/ml or less.(ABSTRACT TRUNCATED AT 250 WORDS)

  11. A comparative, cross-over, double blind, randomized study for bioequivalence assessment between two formulations of valsartan capsules vs. tablets

    Directory of Open Access Journals (Sweden)

    Milena Pérez

    2006-06-01

    Full Text Available Introduction: Bioequivalence or compared equivalence studies are used to demonstrate claims that the new product, named generic product, will have the same bioavailability as the reference product, named brand product. If two products are bioequivalent it means that they would expect to have the same efficacy and security. Bioequivalence is established by the statistical estimation of significant differences or not in the pharmacokinetics parameters of area under the curve (AUC and maximum concentration (Cmax. In this case, bioequivalence will be evaluated and the bioavailability of Valsartan will be compared. Valsartan is an agent antihypertensive and specific angiotensin II antagonist acting on the AT1 receptor subtype. Objective: The aim of this study was to evaluate the bioequivalence of two pharmaceutical products whose active principle is Valsartan, based on the comparison of the pharmacokinetic measures of rate and extent (in terms of required time in which valsartan reaches the sanguineous circulation after a oral dose to 15 volunteers. Metodology: This was a randomized crossover double blind single-dose study on 15 male healthy volunteers aged between 19 and 28 years. The study was performed in two periods. Each treatment period consisted of a single-dose of 320 mg valsartan, with a wash-out time of 8 days between the first and second period. Plasma concentrations of valsartan were evaluated by HPLC/UV with method of addition of valsartan standard and losartan as internal standard. Results: Valsartan tablets formulation showed this pharmacokinetic parameters: AUC 44,893 µg/mlxh, Cmax 6,430.3 µg/ml and Tmax 2 h. Valsartan capsules formulation showed this pharmacokinetic parameters: AUC 44,963 µg/mlxh, Cmax 5,831.4 µg/ml and Tmax 2.5 h. Conclusion: The study showed no statistically significant differences in the plasma concentration levels after administration of the two formulations of valsartan: 80 mg tablets and 80 mg capsules. So

  12. A comparative, cross-over, double blind, randomized study for bioequivalence assessment between two formulations of valsartan capsules vs. tablets.

    Directory of Open Access Journals (Sweden)

    Milena Pérez

    2009-11-01

    Full Text Available Introduction: Bioequivalence or compared equivalence studies are used to demonstrate claims that the new product, named generic product, will have the same bioavailability as the reference product, named brand product. If two products are bioequivalent it means that they would expect to have the same efficacy and security. Bioequivalence is established by the statistical estimation of significant differences or not in the pharmacokinetics parameters of area under the curve (AUC and maximum concentration (Cmax. In this case, bioequivalence will be evaluated and the bioavailability of valsartan will be compared. Valsartan is an agent antihypertensive and specific angiotensin II antagonist acting on the AT1 receptor subtype. Objective: The aim of this study was to evaluate the bioequivalence of two pharmaceutical products whose active principle is Valsartan, based on the comparison of the pharmacokinetic measures of rate and extent (in terms of required time in which valsartan reaches the sanguineous circulation after a oral dose to 15 volunteers. Metodology: This was a randomized crossover double blind single-dose study on 15 male healthy volunteers aged between 19 and 28 years. The study was performed in two periods. Each treatment period consisted of a single-dose of 320 mg valsartan, with a wash-out time of 8 days between the first and second period. Plasma concentrations of valsartan were evaluated by HPLC/UV with method of addition of valsartan standard and losartan as internal standard. Results: Valsartan tablets formulation showed this pharmacokinetic parameters: AUC 44,893 µg/mlxh, Cmax 6,430.3 µg/ml and Tmax 2 h. Valsartan capsules formulation showed this pharmacokinetic parameters: AUC 44,963 µg/mlxh, Cmax 5,831.4 µg/ml and Tmax 2.5 h. Conclusion: The study showed no statistically significant differences in the plasma concentration levels after administration of the two formulations of valsartan: 80 mg tablets and 80 mg capsules. So

  13. A double-blind study comparing the safety, tolerability, and efficacy of ioversol 320 and iopamidol-300 in cerebral angiography.

    Science.gov (United States)

    Ringel, K; Kuehn, J

    1989-06-01

    Ioversol is a new nonionic, triiodinated, water-soluble contrast medium. In a controlled double-blind study, ioversol 320 versus iopamidol-300 was tested on 60 patients in cerebral angiography. The safety of the contrast medium, the general and local tolerance, as well as the contrast quality were tested. In this study, ioversol 320 displayed no differences from iopamidol-300 in terms of contrast quality, neurologic status, and liver and kidney tolerance. In the local tolerance test, patients receiving ioversol 320 perceived significantly less heat than patients receiving iopamidol-300 when all injections were considered.

  14. 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.

  15. A comparative neuroanatomic study of retinal projections in two fishes: Astyanax hubbsi (the blind cave fish), and Astyanax mexicanus.

    Science.gov (United States)

    Voneida, T J; Sligar, C M

    1976-01-01

    Retinofugal projections in the blind cave fish A. hubbsi and in the highly visual A. mexicanus were studied with both reduced silver and autoradiographic methods. Contrary to what has been reported for other teleosts, ipsilateral, as well as the generally accepted contralateral, projections were found in A. mexicanus. Bilateral retinofugal projections were traced to the dorsolateral thalamic nucleus and area pretectalis. Contralateral projections were traced to the lateral geniculate nucleus, nucleus pretectalis, accessory optic nucleus, nucleus corticalis, nucleus opticus hypothalamicus and the superficial layers of the optic tectum (strata opticum, fibrosum and griseum superficiale, and the cellular zone of griseum centrale). Retinal efferents in the blindfish, A. hubbsi, are sparse and totally crossed. Areas receiving a retinal projection include nucleus opticus hypothalamicus, lateral geniculate and the superficial layers of the medial third of the optic tectum. Preliminary behavioral studies are described and discussed in relation to the possible visual potential of this teleost.

  16. Analgesic, Sedative and Hemodynamic Effects of Dexmedetomidine Following Major Abdominal Surgeries: A Randomized, Double Blinded Comparative Study with Morphine

    Directory of Open Access Journals (Sweden)

    Khaled Taha

    2003-09-01

    Full Text Available This was a randomized double-blinded study; in which 60 ASAI-II adult patients scheduled for major abdominal surgeries (colostomy, radical cystectomy, major gynecological surgery, and abdominal vascular surgery were received standard general anesthesia. Twenty minutes before the anticipated end of surgery, patients were randomized into two equal groups: dexmedetomidine group (group D and morphine group (group M. Group D received dexmedetomidine IV infusion 4µg/kg/h for 15 minutes (1µg/Kg followed by 0.4µg/kg/h for 3h. Group M received morphine sulfate IV (0.07mg/kg. All patients were given a morphine patient controlled analgesia (PCA pump in the post anesthesia care unit (PACU, delivering IV morphine 2mg with a lockout time of 5 minutes if pain score assessed through visual analog scale (VAS was more than 5 at any given 5-min assessment. During the PACU recovery period, morphine consumption; pain and sedation scores; hemodynamic variables (heart rate, mean arterial blood pressure, oxygen saturation and respiratory rate; and postoperative nausea, retching and vomiting (PONV were recorded every 30 min for 3h (study period by a member of staff blinded to the treatment. The study demonstrated that the use of dexmedetomidine led to significant decrease in the total amount of morphine consumed throughout the entire PACU recovery period (P0.05; significant decrease in mean arterial pressure (P0.05; without any significant changes in oxygen saturation (P<0.05 or respiratory rate (P<0.05. In conclusion, dexmedetomidine exhibited both analgesic and sedative properties. The associated cardiovascular protective pharmacological profile and the lack of respiratory depression made it potentially extremely interesting for postoperative analgesia after major abdominal surgeries.

  17. A double-blind randomised controlled study comparing subacromial injection of tenoxicam or methylprednisolone in patients with subacromial impingement.

    Science.gov (United States)

    Karthikeyan, S; Kwong, H T; Upadhyay, P K; Parsons, N; Drew, S J; Griffin, D

    2010-01-01

    We have carried out a prospective double-blind randomised controlled trial to compare the efficacy of a single subacromial injection of the non-steroidal anti-inflammatory drug, tenoxicam, with a single injection of methylprednisolone in patients with subacromial impingement. A total of 58 patients were randomly allocated into two groups. Group A received 40 mg of methylprednisolone and group B 20 mg of tenoxicam as a subacromial injection along with lignocaine. The Constant-Murley shoulder score was used as the primary outcome measure and the Disability of Arm, Shoulder and Hand (DASH) and the Oxford Shoulder Score (OSS) as secondary measures. Six weeks after injection the improvement in the Constant-Murley score was significantly greater in the methylprednisolone group (p = 0.003) than in the tenoxicam group. The improvement in the DASH score was greater in the steroid group and the difference was statistically significant and consistent two (p < 0.01), four (p < 0.01) and six weeks (p < 0.020) after the injection. The improvement in the OSS was consistently greater in the steroid group than in the tenoxicam group. Although the difference was statistically significant at two (p < 0.001) and four (p = 0.003) weeks after the injection, it was not at six weeks (p = 0.055). Subacromial injection of tenoxicam does not offer an equivalent outcome to subacromial injection of corticosteroid at six weeks. Corticosteroid is significantly better than tenoxicam for improving shoulder function in tendonitis of the rotator cuff after six weeks.

  18. 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

    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 (t=-78, p<0.44) or in the quality (t=-99, p<0.34). With respect to performance, it was possible to demonstrate a strong treatment effect. In the practical (t=-3.33, p<0.002, d=0.943) and in the total score (t=-2.65, p<0.011, d=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

  19. 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

  20. A comparative, cross-over, double blind, randomized study for bioequivalence assessment between two formulations of valsartan capsules vs. tablets

    National Research Council Canada - National Science Library

    Milena Pérez, , William Cárdenas, Gloria Ramírez, Mauricio Pérez, Piedad Restrepo

    2006-01-01

    Introduction: Bioequivalence or compared equivalence studies are used to demonstrate claims that the new product, named generic product, will have the same bioavailability as the reference product, named brand product...

  1. A comparative, cross-over, double blind, randomized study for bioequivalence assessment between two formulations of valsartan capsules vs. tablets

    National Research Council Canada - National Science Library

    Milena Pérez; William Cárdenas; Gloria Ramírez; Mauricio Pérez; Piedad Restrepo

    2009-01-01

    Introduction: Bioequivalence or compared equivalence studies are used to demonstrate claims that the new product, named generic product, will have the same bioavailability as the reference product, named brand product...

  2. 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.

  3. A randomized, double-blind, placebo-controlled study to investigate the safety, tolerability, and pharmacokinetics of single enantiomer (+)-mefloquine compared with racemic mefloquine in healthy persons.

    Science.gov (United States)

    Tansley, Robert; Lotharius, Julie; Priestley, Anthony; Bull, Fiona; Duparc, Stephan; Möhrle, Jörg

    2010-12-01

    Racemic mefloquine is a highly effective antimalarial whose clinical utility has been compromised by its association with neuropsychiatric and gastrointestinal side effects. It is hypothesized that the cause of the side effects may reside in the (-) enantiomer. We sought to compare the safety, tolerability and pharmacokinetic profile of (+)-mefloquine with racemic mefloquine in a randomized, ascending-dose, double-blind, active and placebo-controlled, parallel cohort study in healthy male and female adult volunteers. Although differing in its manifestations, both study drugs displayed a substantially worse tolerability profile compared with placebo. The systemic clearance was slower for (-)-mefloquine than (+)-mefloquine. Thus, (+)-mefloquine has a different safety and tolerability profile compared with racemic mefloquine but its global safety profile is not superior and replacement of the currently used antimalarial drug with (+)-mefloquine is not warranted.

  4. 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.

  5. [Comparative study of two antitussive drugs in the treatment of acute dry cough of infectious origin (prospective, randomized, single blind study)].

    Science.gov (United States)

    Pujet, J C; Keddad, K; Sévenier, F; Jolivet-Landreau, I

    2002-01-01

    The objective was to compare, during a 5-day therapy, the efficacy and tolerability of an antihistaminic antitussive syrup, oxomemazine, combining a small quantity of guaifenesine (T), with a centrally acting antitussive, clobutinol (S), in adult patients aged from 18 to 70 years and presenting with a dry cough of infectious origin. This study was performed by 22 general practitioners and 130 ambulatory patients were enrolled. The primary criterion of this multicenter, randomized, single blind study was to compare the evolution of cough intensity using a Visual Analog Squale (VAS) graduated from 0 to 10 cm. Nine secondary criteria including tolerability were also assessed. With regard to cough intensity, the treatments were not equivalent. A greater reduction was observed with T (-5.2 +/- 2.3 versus -4.3 +/- 2.3). This result was confirmed by a further reduction in cough intensity at days: 2 (p = 0.04), 4 (p = 0.05), and 5 (p = 0.02). The frequency of cough disappearance before the end of the study was significantly greater for T than for S: 46% versus 29% (p = 0.05). The time before disappearance of the cough was 4.0 + 1.1 days for both medicines. Induction of sleep and the frequency of nocturnal wakening were significantly better for T from day 4 (p = 0.02). The drowsiness induced by T meant that diurnal quality of life was better with S on days 1 (p = 0.002) and 2 (p = 0.01). Tolerability was similar for both medicines. In conclusion, as a symptomatic treatment of dry cough, T is efficient and well tolerated. Moreover, we have observed a tendency towards superior efficacy of T than S. T is therefore a useful alternative in the therapeutic armamentarium available to the general practitioner.

  6. Efficacy and safety of pioglitazone added to alogliptin in Japanese patients with type 2 diabetes mellitus: a multicentre, randomized, double-blind, parallel-group, comparative study.

    Science.gov (United States)

    Kaku, K; Katou, M; Igeta, M; Ohira, T; Sano, H

    2015-12-01

    A phase IV, multicentre, randomized, double-blind, parallel-group, comparative study was conducted in Japanese subjects with type 2 diabetes mellitus (T2DM) who had inadequate glycaemic control, despite treatment with alogliptin in addition to diet and/or exercise therapy. Subjects with glycated haemoglobin (HbA1c) concentrations of 6.9-10.5% were randomized to receive 16 weeks' double-blind treatment with pioglitazone 15 mg, 30 mg once daily or placebo added to alogliptin 25 mg once daily. The primary endpoint was the change in HbA1c from baseline at the end of treatment period (week 16). Both pioglitazone 15 and 30 mg combination therapy resulted in a significantly greater reduction in HbA1c than alogliptin monotherapy [-0.80 and -0.90% vs 0.00% (the least squares mean using analysis of covariance model); p Pioglitazone/alogliptin combination therapy was effective and generally well tolerated in Japanese subjects with T2DM and is considered to be useful in clinical settings.

  7. Monochromatic excimer light versus combination of topical steroid with vitamin D3 analogue in the treatment of nonsegmental vitiligo: a randomized blinded comparative study.

    Science.gov (United States)

    Abdel Latif, Azmy Ahmed; Ibrahim, Shady Mahmoud Attia

    2015-01-01

    Vitiligo is a difficult disease to treat, socially stigmatizing its patients. Monochromatic excimer light (MEL) was developed for use in dermatology and adapted for the treatment of vitiligo. Comparing the efficacy of MEL versus topical combination therapy of vitamin D3 analogue and steroid in the treatment of nonsegmental vitiligo. Forty-four patients with localized and stable nonsegmental vitiligo participated in the present study. In each patient, two lesions were selected and divided randomly into two groups, group A was treated with daily topical combination of calcipotriol and betamethasone and group B was treated with biweekly sessions of MEL for 3 months. Efficacy based on repigmentation percentages were blindly evaluated by two independent physicians and patient's satisfaction. There was significant improvement in both treatment modalities at the end of the study, but without significant differences in both groups. There was a significant difference between both groups regarding the onset of repigmentation (p-value vitiligo.

  8. Comparing the effects of two inhaled glucocorticoids on allergen-induced bronchoconstriction and markers of systemic effects, a randomised cross-over double-blind study

    Directory of Open Access Journals (Sweden)

    Lötvall Jan

    2011-10-01

    Full Text Available Abstract Background Inhaled glucocorticoids are efficient in protecting against asthma exacerbations, but methods to compare their efficacy vs systemic effects have only been attempted in larger multi-centre studies. The aim of the current study was therefore to directly compare the effects of two separate inhaled glucocorticoids, mometasone and budesonide, to compare the effects on the early and late asthmatic responses to inhaled allergen in patients with mild allergic asthma, and sputum eosinophils, and to relate the clinical positive effects to any systemic effects observed. Methods Twelve patients with documented early and late asthmatic responses (EAR and LAR to inhaled allergen at a screening visit were randomized in a double-blind fashion to treatment with mometasone (200 μg × 2 or 400 μg × 2, budesonide (400 μg × 2 or placebo in a double-blind crossover fashion for a period of seven days. Challenge with the total allergen dose causing both an EAR and LAR was given on the last day of treatment taken in the morning. Lung function was assessed using FEV1, and systemic glucocorticoid activity was quantified using 24 h urinary cortisol. Results Mometasone and budesonide attenuate both EAR and LAR to allergen to a similar degree. No significant dose-related effects on the lung function parameters were observed. Both treatments reduced the relative amount of sputum eosinophils (% after allergen. At the dose of 800 μg daily, mometasone reduced 24 h urinary cortisol by approximately 35%. Both drugs were well tolerated. Conclusions Mometasone and budesonide are equieffective in reducing early and late asthmatic responses induced by inhaled allergen challenge. Mometasone 800 μg given for seven days partially affects the HPA axis.

  9. Efficacy of ajoene in the treatment of tinea pedis: a double-blind and comparative study with terbinafine.

    Science.gov (United States)

    Ledezma, E; Marcano, K; Jorquera, A; De Sousa L; Padilla, M; Pulgar, M; Apitz-Castro, R

    2000-11-01

    Ajoene, an organosulfur compound originally isolated from garlic, has been shown to be effective in short-term treatment of tinea pedis. We compare the safety and effectiveness of twice-daily topical application during 1 week of 0.6% and 1% ajoene and 1% terbinafine in the treatment of tinea pedis. Seventy soldiers from the Venezuelan Armed Forces, with clinical and mycologic diagnosis of tinea pedis, were included in this study. However, only 47 were available for final evaluation. The patients were randomly distributed into 3 treatment groups: 0.6% ajoene, 1% ajoene, and 1% terbinafine. Clinical follow-up shows a rapid decline in the signs and symptoms in all groups. Efficacy of the treatments, measured as mycologic cure, 60 days after the end of the therapy was 72% for 0.6% ajoene, 100% for 1% ajoene, and 94% for 1% terbinafine. This represents the first demonstration of the therapeutic application of an inhibitor of phospholipid biosynthesis in human dermatophytosis.

  10. A double-blind group comparative study of ophthalmic sodium cromoglycate, 2% four times daily and 4% twice daily, in the treatment of seasonal allergic conjunctivitis.

    Science.gov (United States)

    Leino, M; Montan, P; Njå, F

    1994-03-01

    In a multicenter, double-blind, single-dummy, group-comparative study, 169 patients received ophthalmic sodium cromoglycate 2% four times daily, and 170 patients received 4% ophthalmic sodium cromoglycate twice daily, together with placebo eye-drops twice daily, for the treatment of seasonal allergic conjunctivitis (SAC) to birch pollen. The treatment period was 4 weeks during the birch pollen season. Daily pollen counts were used to identify the peak 14-d period. Clinical examinations were made before the start of treatment, after 1 week of treatment, and at the end of the treatment period. Patients kept daily diary record cards of eye symptom severity and concomitant therapy. Symptoms were generally mild and, except for chemosis (week 4) and soreness (weeks 2 and 3), which were less in the 4% group (P sodium cromoglycate eye-drops twice daily is as effective and well tolerated as 2% sodium cromoglycate four times daily in the treatment of birch-pollen conjunctivitis.

  11. A randomized, placebo-controlled double-blinded comparative clinical study of five over-the-counter non-pharmacological topical analgesics for myofascial pain: single session findings

    Directory of Open Access Journals (Sweden)

    Avrahami Daniel

    2012-03-01

    Full Text Available Abstract Objectives To investigate the effects of topical agents for the treatment of Myofascial Pain Syndrome (MPS and Myofascial Trigger Point (MTRP. Methods Subjects with an identifiable trigger point in the trapezius muscle, age 18-80 were recruited for a single-session randomized, placebo-blinded clinical study. Baseline measurements of trapezius muscle pressure pain threshold (PPT: by pressure algometer along with right and left cervical lateral flexion (rangiometer were obtained by a blinded examiner. An assessor blinded to the outcomes assessments applied one of 6 topical formulations which had been placed in identical plastic containers. Five of these topicals were proposed active formulations; the control group was given a non-active formulation (PLA. Five minutes after the application of the formula the outcome measures were re-tested. Data were analyzed with a 5-way ANOVA and Holms-adjusted t-tests with an alpha level of 0.05. Results 120 subjects were entered into the study (63 females; ages 16-82; 20 subjects randomly allocated into each group. The pre- and post-treatment results for pressure threshold did show significant intra-group increases for the Ben-Gay Ultra Strength Muscle Pain Ointment (BG, the Professional Therapy MuscleCare Roll-on (PTMC roll-on and Motion Medicine Cream (MM with an increased threshold of 0.5 kg/cm2 (+/-0.15, 0.72 kg/cm2 (+/-0.17 and 0.47 Kg/cm2 (+/-0.19 respectively. With respect to the inter-group comparisons, PTMC roll-on showed significant increases in pressure threshold compared with Placebo (PLA (p = 0.002 and Icy Hot Extra Strength Cream (IH (p = 0.006. In addition, BG demonstrated significant increases in pressure threshold compared with PLA (p = 0.0003. Conclusions With regards to pressure threshold, PTMC roll-on, BG and MM showed significant increases in pain threshold tolerance after a short-term application on a trigger points located in the trapezius muscle. PTMC roll-on and BG were both

  12. A prospective, randomized, double-blinded single-site control study comparing blood loss prevention of tranexamic acid (TXA to epsilon aminocaproic acid (EACA for corrective spinal surgery

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    Vaz Kenneth M

    2010-04-01

    Full Text Available Abstract Background Multilevel spinal fusion surgery has typically been associated with significant blood loss. To limit both the need for transfusions and co-morbidities associated with blood loss, the use of anti-fibrinolytic agents has been proposed. While there is some literature comparing the effectiveness of tranexamic acid (TXA to epsilon aminocaproic acid (EACA in cardiac procedures, there is currently no literature directly comparing TXA to EACA in orthopedic surgery. Methods/Design Here we propose a prospective, randomized, double-blinded control study evaluating the effects of TXA, EACA, and placebo for treatment of adolescent idiopathic scoliosis (AIS, neuromuscular scoliosis (NMS, and adult deformity (AD via corrective spinal surgery. Efficacy will be determined by intraoperative and postoperative blood loss. Other clinical outcomes that will be compared include transfusion rates, preoperative and postoperative hemodynamic values, and length of hospital stay after the procedure. Discussion The primary goal of the study is to determine perioperative blood loss as a measure of the efficacy of TXA, EACA, and placebo. Based on current literature and the mechanism by which the medications act, we hypothesize that TXA will be more effective at reducing blood loss than EACA or placebo and result in improved patient outcomes. Trial Registration ClinicalTrials.gov ID: NCT00958581

  13. Efficacy of blue light vs. red light in the treatment of psoriasis: a double-blind, randomized comparative study.

    NARCIS (Netherlands)

    Kleinpenning, M.M.; Otero, M.E.; Erp, P.E.J. van; Gerritsen, M.J.P.; Kerkhof, P.C.M. van de

    2012-01-01

    BACKGROUND: Protoporphyrin IX is present in psoriatic skin without the preceding application of aminolevulinic acid. Therefore, endogenous photosensitizers in psoriasis are a potential target for photodynamic treatment with high-dose visible light. OBJECTIVES: In the present pilot study, treatment w

  14. [The efficacy of drug therapy in structural lesions of the hair and in diffuse effluvium--comparative double blind study].

    Science.gov (United States)

    Petri, H; Pierchalla, P; Tronnier, H

    1990-11-20

    Growth and quality of hair was studied after treatment with Pantogar, another prescription (Verum-2) and placebo for four months in 60 patients with diffuse effluvium capillorum and agnogenic structural alternations of hair. Efficacy was assessed by measurements of swelling, dye-binding and thickness for hair-quality and evaluation of hair-density and trichograms for hair-growth. Statistical analysis of swelling properties and trichogram data indicated that Pantogar was effective, the second preparation improved quality of hair and retarded hair loss. Placebo was ineffective judged by the used parameters. Tolerance of the treatment was good and adverse effects could not be substantiated.

  15. 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

    Einleitung: Für die Unterrichtsgestaltung zur Einführung der chirurgischen Händedesinfektion stehen unterschiedliche Lernmethoden zur Verfügung. Diese Lernmethoden sollen dabei helfen, das Unterrichtsthema zu strukturieren und zu bewältigen. Der Einsatz eines Videofilms ist, durch die realen Darstellungsmöglichkeiten der praktischen Demonstration, eine Alternative zum konventionellen Unterricht. Ziel: Mit der vorliegenden Studie wird vergleichend untersucht, welche Vermittlungsform effektiver für das Erlernen und Anwenden der chirurgischen Händedesinfektion von Medizinstudenten im 1. Studienjahr ist: videobasierte Instruktion oder konventioneller Unterricht.Methodik: Insgesamt wurden 50 Medizinstudierende im 1. Studienjahr per Zufall entweder der Lerngruppe „konventionelle Instruktion“ (KI) oder der Lerngruppe „videobasierte Instruktion“ (VI) zugeordnet. Die konventionelle Instruktion erfolgte durch einen erfahrenen Nurse Preceptors/Nurse Educators für den Operationssaal, der die vorzubereitenden Massnahmen sowie die eigentliche Prozedur im Rahmen einer zweiminütigen Lektion vermittelte. Die zweite Gruppe sah eine Videosequenz von 2 Minuten mit identischen Inhalten. Beide Gruppen demonstrierten ihr akkumuliertes Wissen im Anschluss praktisch an einer einzelnen praktischen Prüfungsstation. Die Güte (a) der Vorbereitung und (b) der Prozedur wurde ebenso wie (c) die Qualität des Ergebnisses von 6 geblendeten Experten anhand einer Checkliste beurteilt. Die Akzeptanz der jeweiligen Vermittlungsform wurde mittels eines Fragebogens erfragt.Ergebnisse: Die Gruppenleistungen unterschieden sich weder in der Vorbereitung (t=-78, p<0.44) noch in der Qualität (t=-99, p<0.34). In Hinblick auf die Performanz konnte ein starker Treatment-Effekt nachgewiesen werden. In der Durchführung (t=-3.33, p<0.002, d=0.943) sowie im Total Score (t=-2.65, p<0.011, d=0.751) erzielte die Gruppe mit videobasierter Instruktion ein signifikant besseres Ergebnis. Auf die Frage

  16. DOUBLE BLIND COMPARATIVE STUDY OF SOMMERLAD’S LEVATOR MYOPLASTY AND FURLOW’S DOUBLE OPPOSING Z PLASTY

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    Mohana Rao

    2015-06-01

    Full Text Available AIMS AND OBJECTIVES : Aim of this study is to make out efficiency of these surgical techniques in correction of Velopharyngeal incompetence (V.P.I. MATERIALS AND METHODS: 20 cases of Velopharyngeal incompetence initially screened by speech therapist followed by accessing velopharyngeal gap and documenting in patients between 5to 15 years age group of both the sexes. T hey were randomly allotted for Furlow’s double opposing Z plasty and Sommerlads’s levator myoplasty. All these procedures were done by the same surgeon to avoid surgeon bias. Two to three years after surgery all these patients were subjected for Videofluroscopy. Velopharyngeal gaps were recorded and documented. Preoperative and post - operative Velopharyngeal gaps were recorded and analysed. RESULTS AND CONCLUSION: Both these technique s were equally efficacious in correction of Velopharyngeal incompetence if Velopharyngeal gap is less than 5mm. However both these t echniques were failed to close if Velopharyngeal gap is more than 5mm.In such cases posterior wall augmentation was needed to obtain Velopharyngeal closure.

  17. 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

    1999-01-01

    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

  18. The Comparing Auditory Discrimination in Blind and Sighted Subjects

    Directory of Open Access Journals (Sweden)

    Dr. Hassan Ashayeri

    2000-05-01

    Full Text Available Studying auditory discrimination in children and the role it plays in acquiring language skills is of great importance. Also the relationship between articulation disorder and the ability to discriminate the speech sound is an important topic for speech and language researchers. Previous event- related potentials (ERPs studies have suggested a possible participation of the visual cortex of the blind subjects were asked to discriminate 100 couple Farsi words (auditory discrimination tack while they were listening them from recorded tape. The results showed that the blinds were able to discriminate heard material better than sighted subjects. (Prro.05 According to this study in blind subjects conical are as normally reserved for vision may be activated by other sensory modalities. This is in accordance with previous studies. We suggest that auditory cortex expands in blind humans.

  19. 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.

  20. Comparative, double-blind, controlled study of intra-articular hyaluronic acid (Hyalubrix®) injections versus local anesthetic in osteoarthritis of the hip

    Science.gov (United States)

    2009-01-01

    Introduction Comparison of intra-articular bacterial-derived hyaluronic acid (Hyalubrix®) (HA) with local analgesia (mepivacaine) for osteoarthritis (OA) of the hip. Methods A pilot prospective, double-blind, 6-month randomized trial of 42 patients with hip OA. HA or mepivacaine was administered twice (once a month) under ultrasound guidance. Efficacy measurements included the Lequesne's algofunctional index, a visual analog scale for pain, concomitant use of analgesia, patient and physician global measurement, and safety. Results Patients in the HA group exhibited a significantly reduced Lequesne's algofunctional index 3 and 6 months after treatment (P < 0.001) and significantly reduced visual analog scale pain scores 3 and 6 months after treatment (P < 0.05) compared with the local anesthetic group. All primary and secondary measures were significantly improved versus baseline, but other than the above were not different from each other at 3 or 6 months. Adverse effects were minimal. Conclusions This comparative study suggests a beneficial effect and safety of intra-articular HA in the management of hip OA. Trial registration number ISRCTN39397064. PMID:20003205

  1. Efficacy and tolerability of a polysaccharide-resin-honey based cough syrup as compared to carbocysteine syrup for children with colds: a randomized, single-blinded, multicenter study.

    Science.gov (United States)

    Cohen, Herman Avner; Hoshen, Moshe; Gur, Shmuel; Bahir, Arie; Laks, Yoseph; Blau, Hannah

    2017-02-01

    Available pediatric treatments for acute cough are limited by lack of demonstrated efficacy. The objective of this trial is to compare the effects of a polysaccharide-resin-honey based cough syrup, and carbocysteine syrups on nocturnal and daytime cough associated with childhood upper respiratory tract infections (URIs). Using a single-blind randomization design, the study recruited children from 4 general pediatric community clinics. Participants included 150 children aged 2 to 5 years with an URI, nocturnal and daytime cough and illness duration of ≤7 days. To be eligible, children had to be free of medication on the day before presentation. A survey was administered to parents on 4 consecutive days beginning from the day of presentation in clinic. Children received the study preparation on the first evening and then 3 times per day for 3 further days. Main outcome measures were cough frequency, cough severity, bothersome nature of cough, and quality of sleep for both child and parent. Both preparations were well tolerated and cough improved over the study period. After one night and on all survey days, there was a significantly better result for polysaccharide-resin-honey (Pcarbocysteine cough syrups were well tolerated in children over 2 years of age. The polysaccharide-resin-honey syrup was associated with a more rapid and greater improvement in all clinical cough symptoms measured, beginning from the first night of therapy. Both nocturnal and daytime cough improved, as did sleep quality for both children and parents.

  2. Comparative efficacy of nimesulide and ketoprofen on inflammatory events in third molar surgery: a split-mouth, prospective, randomized, double-blind study.

    Science.gov (United States)

    Pouchain, E C; Costa, F W G; Bezerra, T P; Soares, E C S

    2015-07-01

    This study aimed to compare the effect of nimesulide and ketoprofen on inflammatory parameters related to the surgical removal of third molars. A split-mouth, prospective, randomized, double-blind study was conducted in patients undergoing removal of four third molars. Eighteen eligible patients were allocated to one of two groups to receive treatment two times a day with either ketoprofen 100 mg or nimesulide 100 mg for a period of 3 days. The rescue medication intake (number) and pain intensity were evaluated at 6, 12, 24, and 48 h, and at 7 days postoperatively. Swelling and maximum mouth opening were evaluated at 24 h, 72 h, and 7 days postoperatively. The peak pain score occurred at 6h after surgery in the nimesulide group and at 12h in the ketoprofen group. There was no statistically significant difference between the groups, although pain relief was observed after 48 h in the nimesulide group and after 7 days in the ketoprofen group. For each group, there was a statically significant difference in pain scores among the studied periods (PKetoprofen and nimesulide were effective at controlling pain, swelling, and trismus after the surgical removal of third molars.

  3. A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy

    Science.gov (United States)

    Emery, Paul; Vencovský, Jiří; Sylwestrzak, Anna; Leszczyński, Piotr; Porawska, Wieslawa; Baranauskaite, Asta; Tseluyko, Vira; Zhdan, Vyacheslav M; Stasiuk, Barbara; Milasiene, Roma; Barrera Rodriguez, Aaron Alejandro; Cheong, Soo Yeon; Ghil, Jeehoon

    2017-01-01

    Objectives To compare the efficacy and safety of SB4 (an etanercept biosimilar) with reference product etanercept (ETN) in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate (MTX) therapy. Methods This is a phase III, randomised, double-blind, parallel-group, multicentre study with a 24-week primary endpoint. Patients with moderate to severe RA despite MTX treatment were randomised to receive weekly dose of 50 mg of subcutaneous SB4 or ETN. The primary endpoint was the American College of Rheumatology 20% (ACR20) response at week 24. Other efficacy endpoints as well as safety, immunogenicity and pharmacokinetic parameters were also measured. Results 596 patients were randomised to either SB4 (N=299) or ETN (N=297). The ACR20 response rate at week 24 in the per-protocol set was 78.1% for SB4 and 80.3% for ETN. The 95% CI of the adjusted treatment difference was −9.41% to 4.98%, which is completely contained within the predefined equivalence margin of −15% to 15%, indicating therapeutic equivalence between SB4 and ETN. Other efficacy endpoints and pharmacokinetic endpoints were comparable. The incidence of treatment-emergent adverse events was comparable (55.2% vs 58.2%), and the incidence of antidrug antibody development up to week 24 was lower in SB4 compared with ETN (0.7% vs 13.1%). Conclusions SB4 was shown to be equivalent with ETN in terms of efficacy at week 24. SB4 was well tolerated with a lower immunogenicity profile. The safety profile of SB4 was comparable with that of ETN. Trial registration numbers NCT01895309, EudraCT 2012-005026-30. PMID:26150601

  4. Kojic Acid vis-a-vis its Combinations with Hydroquinone and Betamethasone Valerate in Melasma: A Randomized, Single Blind, Comparative Study of Efficacy and Safety

    Science.gov (United States)

    Deo, Kirti S.; Dash, Kedar N.; Sharma, Yugal K.; Virmani, Neha C.; Oberai, Chetan

    2013-01-01

    Background: Melasma is a relatively common, acquired symmetric hypermelanosis characterized by irregular light to gray-brown macules involving sun-exposed areas. Kojic acid, with its depigmenting potential due to tyrosinase inhibition and suppression of melanogenesis, has become a vital component of the dermatologists’ armamentarium against melasma. Aim: To study and compare the efficacy of kojic acid 1% alone, vis-a-vis its separate combinations with 2% hydroquinone or 0.1% betamethasone valerate and a combination of all these three agents with respect to the duration of symptoms and level of pigmentation in the therapy of melasma. Materials and Methods: Eighty patients from a single tertiary care center objectively assessed by calculating the melasma area severity index (MASI) and randomized (simple randomization) into four parallel groups (A, B, C, and D) of 20 each were prescribed once daily local application at night, (participants blinded regarding the difference in identity of interventions), as follows: Group A – kojic acid 1% cream. Group B – kojic acid 1% and hydroquinone 2% cream. Group C – kojic acid 1% and betamethasone valerate 0.1% cream. Group D – kojic acid 1%, hydroquinone 2%, and betamethasone valerate 0.1% cream. Strict photoprotection and use of a SPF 15 sunscreen was advised during the day. Patients were evaluated every 2 weeks and a fall in MASI score was calculated at the end of the study period of 12 weeks by the same investigator. Results: The response was compared according to percentage decrease in MASI score. Efficacy was evaluated among the groups at the end of 3 months using bivariate analysis and calculated by using the paired ‘t’ test. The clinical efficacy of group B was the highest followed closely by group D and group A, that of group C being the lowest. Conclusion: Kojic acid in synergy with hydroquinone is a superior depigmenting agent as compared with other combinations. PMID:23918998

  5. 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

    2017-07-04

    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 emollients can perform differently. Dermal Laboratories Ltd. EudraCT number:2014-001026-16.

  6. Comparative efficacy and tolerability of pholcodine and dextromethorphan in the management of patients with acute, non-productive cough : a randomized, double-blind, multicenter study.

    Science.gov (United States)

    Equinozzi, Roberto; Robuschi, Maria

    2006-01-01

    The aim of this study was to compare the efficacy and tolerability of pholcodine with that of dextromethorphan, one of the most used cough sedative products, in patients with acute, non-productive cough. 129 adults with a diagnosis of acute, frequent, non-productive cough participated in a randomized, double-blind, parallel-group, multicenter trial. Medications were in a syrup formulation and were taken orally three times daily for 3 days. The efficacy endpoints were the change from baseline in the daytime and night-time cough frequency on 5-point scales at day 3, and cough intensity. A reduction of 1.4 and 1.3 points in the mean daytime cough frequency at day 3 was seen in the pholcodine and dextromethorphan groups, respectively, in the per-protocol population. The reduction in mean night-time cough was 1.3 for both groups. Cough intensity reduction was 0.7 for pholcodine and 0.8 for dextromethorphan. These findings indicate that the efficacy of a 3-day course of pholcodine is similar to that of dextromethorphan in the treatment of adult patients with acute, non-productive cough. Both medications were well tolerated.

  7. Dilution of botulinum toxin A in lidocaine vs. in normal saline for the treatment of primary axillary hyperhidrosis: a double-blind, randomized, comparative preliminary study.

    Science.gov (United States)

    Güleç, A T

    2012-03-01

    Botulinum toxin A (BTX-A) is an effective and safe treatment modality for primary axillary hyperhidrosis. However, some patients experience considerable pain during injections. Dilution of botulinum toxin A in lidocaine vs. in normal saline for the treatment of primary axillary hyperhidrosis: a double-blind, randomized, comparative preliminary study. The aim of this study was to compare the efficacy, safety and pain tolerance of lidocaine-diluted BTX-A vs. saline-diluted BTX-A for the treatment of axillary hyperhidrosis. Eight patients were injected with 50 U of BTX-A diluted in 0.5 mL of saline and 1 mL of 2% lidocaine into one axilla and 50 U of BTX-A diluted in 1.5 mL of saline into the other axilla in a randomized fashion. The pain associated with the injections were self-assessed by the subjects using a 100-mm visual analogue scale (VAS). Lidocaine-diluted BTX-A and saline-diluted BTX-A were similarly effective regarding the reduction in sweat production, the onset of sweat cessation and the duration of hypo/anhidrosis. Nevertheless, the pain VAS score during the injections was significantly lower in the axilla treated with lidocaine-diluted BTX-A than the one treated with saline-diluted toxin. Preliminary study due to relatively small sample size. Botulinum toxin A diluted in lidocaine causes significantly less pain than BTX-A diluted in saline, whereas it is is equally effective and safe as the latter one in treating axillary hyperhidrosis. Therefore, we suggest that lidocaine-diluted BTX-A may be a better treatment option for the patients with primary axillary hyperhidrosis. © 2011 The Author. Journal of the European Academy of Dermatology and Venereology © 2011 European Academy of Dermatology and Venereology.

  8. Enantioselective effects of levodropropizine and dropropizine on psychomotor functions in normal volunteers: a placebo-controlled, double-blind comparative study.

    Science.gov (United States)

    Gatti, G; Barzaghi, N; Dominijanni, R; Cordaro, C; Perucca, E

    1993-01-01

    Levodropropizine is the l-isomer of dropropizine, a racemic drug widely used as a cough suppressant. Compared with the racemate, levodropropizine retains equal antitussive activity but exhibits considerably lower central nervous system (CNS) depressant effects in animal models. In order to assess whether the same differential pharmacodynamic profile also applies to man, a double-blind placebo-controlled study was carried out to investigate the effects of single oral doses (60 and 120 mg) of levodropropizine and dropropizine on subjective alertness (scored on visual analogue scales), general tolerability and psychomotor function tests (cancellation, tapping, choice reaction times and critical flicker fusion frequency) in ten normal volunteers. Treatments were administered in random sequence at intervals of at least one week, evaluation procedures being carried out at times 0, 1, 2, 3, 4, 6 and 8 h after dosing. Following intake of a 60 mg levodropizine dose, subjective effects and objective estimates of psychomotor function were superimposable to those recorded after placebo. There was a trend for 60 mg dropropizine and 120 mg levodropropizine to produce detrimental effects at occasional evaluations, although the changes associated with these treatments could not be differentiated from placebo on the basis of most subjective scores and psychomotor function tests. Conversely, administration of 120 mg dropropizine was consistently associated with subjective CNS impairment and with reduced performance (compared to baseline) in recognition time, critical flicker fusion thresholds and possibly tapping rate, for up to three hours after dosing. These data are consistent with evidence that racemic dropropizine adversely affects central nervous system function to a greater extent compared with the levo-isomer.

  9. A double-blind comparative study of the safety and efficacy of caspofungin versus micafungin in the treatment of candidiasis and aspergillosis.

    Science.gov (United States)

    Kohno, S; Izumikawa, K; Yoshida, M; Takesue, Y; Oka, S; Kamei, K; Miyazaki, Y; Yoshinari, T; Kartsonis, N A; Niki, Y

    2013-03-01

    The safety and efficacy profile of caspofungin and micafungin in Japanese patients with fungal infections were directly compared in this prospective, randomized, double-blind study. The proportion of patients who developed significant drug-related adverse event(s) (defined as a serious drug-related adverse event or a drug-related adverse event leading to study therapy discontinuation) was compared in 120 patients [caspofungin 50 mg, or 50 mg following a 70-mg loading dose on Day 1 (hereinafter, 70/50 mg) group: 60 patients; micafungin 150 mg: 60 patients]. The overall response rate was primarily evaluated in the per-protocol set (PPS) population. The proportion of patients who developed significant drug-related adverse events was 5.0 % (3/60) in the caspofungin group and 10.0 % (6/60) in the micafungin group [95 % confidence interval (CI) for the difference: -15.9 %, 5.2 %]. The favorable overall response in the PPS population for patients with esophageal candidiasis, invasive candidiasis, and chronic pulmonary aspergillosis including aspergilloma was 100.0 % (6/6), 100.0 % (3/3), and 46.7 % (14/30) in the caspofungin group, and 83.3 % (5/6), 100.0 % (1/1), and 42.4 % (14/33) in the micafungin group, respectively. In Japanese patients with Candida or Aspergillus infections, there was no statistical difference in the safety between caspofungin and micafungin. Consistent with other data on these two agents, the efficacy of caspofungin and micafungin was similar.

  10. A Comparative Effect of Intravenous Pethidine vs Sufentanil on Attenuation of Cardiovascular Responses to Laryngoscopy and Tracheal Intubation: a Randomized Double-Blind Placebo Controlled Trial Study

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    A Honarmand

    2008-07-01

    Full Text Available Background: The study was undertaken to compare the effects of small doses of sufentanil or pethidine on cardiovascular changes induced by tracheal intubation.Patients and Methods: Sixty American Soceity of Anesthesiology (ASA physical status I-II patients, scheduled for elective abdominal surgery under general anesthesia, randomly allocated in a double- blind fashion to receive an intravenous bolus of either sufentanil 0.1 μg/kg (Group S, n = 30 or pethidine 1.5 mg/kg (Group P, n = 30 for induction of anesthesia. The heart rate (HR, systolic arterial pressure (SAP, diastolic arterial pressure (DAP, and mean arterial pressure (MAP were measured before induction of anaesthesia (baseline, at 1-min intervals for 3 min after the induction of anesthesia, at 1, 3, 5, and 7 min after start of laryngoscopy. Results: No significant differences in SAP, DAP, and MAP were observed between the two groups. Heart rate significantly increased 2 and 3 minutes after induction of anesthesia and 1 minute after intubation in group P compared with group S (P<0.01. However, the numbers of patients who developed a heart rate increase more than 20% of basal value were not different between two groups. At the end of the study period, systolic, diastolic, and mean arterial pressure slightly decreased from preinduction values that was transient and did not require treatment.Conclusions: If adequate timing in opioid administration is warranted according to the time to peak effect of each opioid drug, small doses of sufentanil or pethidine exert similar effect in controlling the inotropic response induced by the laryngoscopy and tracheal intubation.

  11. A prospective, randomised, double-blind study of comparative efficacy of immediate versus daily cleaning of stethoscope using 66% ethyl alcohol

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    Parmar Ramesh

    2004-10-01

    Full Text Available OBJECTIVE: Studies have demonstrated frequent contamination of stethoscope and usefulness of different disinfectants. Albeit, studies on the precise mode of cleaning and frequency of cleaning are lacking. This study was carried out to determine efficacy of 66% ethyl alcohol as disinfectant, rate of recontamination without cleaning and benefits of daily versus immediate cleaning. METHODOLOGY: Prospective, randomised, double blind study of 100 stethoscopes. Four cultures were obtained: before cleaning (Group A, immediately after cleaning with 66% ethyl alcohol (Group B, at the end of 4 days without cleaning (Group C and at the end of 4 days after cleaning once a day (Group D. Samples were analysed using standard microbiological methods and Colony-forming unit (CFU count and residual microorganism was computed for all the positive cultures. Medical staff was asked about the cleaning practices. Statistical analysis was carried out using 95% confidence interval and Chi-square test. RESULTS: 90% of the stethoscopes were contaminated with one or more microorganisms. Immediate cleaning and daily cleaning were associated with a significant reduction in the rate of contamination to 28% and 25% respectively. CFU count in groups B and D dropped to less than 10 in 75% and 84.7%, while the mean residual rates were 5.2% and 3.65% respectively. Groups B and D showed no statistically significant difference in terms of efficacy of disinfection. CONCLUSIONS: 66% ethyl alcohol is an effective disinfectant. The effects of immediate cleaning and cleaning once a day on residual flora on the diaphragm of stethoscope is comparable.

  12. The efficacy and safety of blonanserin compared with haloperidol in acute-phase schizophrenia: a randomized, double-blind, placebo-controlled, multicentre study.

    Science.gov (United States)

    Garcia, Esther; Robert, Marta; Peris, Francesc; Nakamura, Hiroshi; Sato, Noriko; Terazawa, Yoshikatsu

    2009-01-01

    Blonanserin is a novel atypical antipsychotic agent with potent dopamine D(2) and serotonin 5-HT(2) antagonist properties. It may potentially have a lower incidence of adverse events than other antipsychotic agents. To determine the efficacy and safety of three doses of blonanserin compared with placebo and haloperidol in patients with acute-phase schizophrenia. This was a 6-week, randomized, double-blind, placebo- and haloperidol-controlled, international, multicentre study. Patients with an acute exacerbation of their schizophrenia, with a Positive and Negative Syndrome Scale (PANSS) score >/=70 and a Clinical Global Impression - Severity of Illness (CGI-S) score >/=4 ('moderately ill') [with no decrease >/=20% or >/=1 point, respectively, during the wash-out period] were randomized into one of five treatment groups (blonanserin 2.5, 5 or 10 mg, haloperidol 10 mg or placebo once daily). Patients were assessed weekly for clinical efficacy, adverse events, extrapyramidal symptoms (EPS) and drug compliance, and were assessed biweekly for other safety variables. All 307 randomized patients received at least one dose of study medication and 228 (74.3%) completed the study. The mean reduction in PANSS total score at week 6 was significantly greater with all active treatments compared with placebo (-12.58; p blonanserin 10 mg was significantly superior to blonanserin 2.5 mg (-30.18 vs -20.6; p blonanserin 5 mg (-27.19) and haloperidol 10 mg (-28.16) were not. All active treatments showed greater efficacy against the positive symptoms of schizophrenia, and blonanserin (5 and 10 mg) was more effective against the negative symptoms than haloperidol. Blonanserin was well tolerated at all doses and there was no evidence of clinically important weight gain, orthostatic hypotension, corrected QT interval prolongation or clinically relevant changes in laboratory test results. Haloperidol caused persistent elevation in prolactin levels, but this was not seen with any dose of

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

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    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. 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

    1996-01-01

    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 mann

  15. Comparative effects of propofol, landiolol, and nicardipine on hemodynamic and bispectral index responses to endotracheal intubation: a prospective, randomized, double-blinded study.

    Science.gov (United States)

    Miyazaki, Masumi; Kadoi, Yuji; Takashi, Sudo; Sawano, Yukari; Shimada, Hitoshi

    2008-06-01

    To examine the comparative effects of propofol, landiolol, and nicardipine on hemodynamic responses and bispectral index (BIS) changes to endotracheal intubation. Operating room of a university-affiliated general hospital. 27 ASA physical status I and II patients who were scheduled to undergo elective general surgical, urological, or gynecological procedures with general anesthesia. Prospective, randomized, double-blinded study. Patients were divided into three groups as follows: Group 1 received propofol, 1 mg/kg; Group 2 received landiolol, 0.1 mg/kg; and Group 3 received nicardipine, 1 mg. After baseline measurements were recorded, anesthesia was induced with propofol, fentanyl, and vecuronium. Patients' lungs were ventilated with 100% oxygen for 120 seconds, at which time one of one of the study drugs was administered. Laryngoscopy and tracheal intubation were performed 4 minutes after anesthetic induction. Cardiac index (CI) and stroke volume index (SVI) were monitored continuously. Bispectral index was also monitored continuously from 5 minutes after tracheal intubation. Heart rate values in Group 3 increased 30 seconds after intubation; this increase lasted for 1 minute after intubation. Systolic blood pressure in all three groups decreased after induction of anesthesia and before tracheal intubation, and values returned closer to baseline values 30 seconds after intubation. In the propofol group, CI and SVI decreased after administration of additional propofol, lasting for 30 seconds after intubation. The BIS values rapidly decreased after induction of anesthesia, with no intergroup differences noted in BIS values (propofol group, 39+/-7; landiolol group, 44+/-14; nicardipine group, 41+/-9). However, BIS was significantly lower in the propofol group than in the other two groups from 30 seconds to 5 minutes after intubation. Landiolol, 0.1 mg/kg, before intubation provides effective hemodynamic stability in the postintubation period.

  16. Comparative evaluation of prophylactic use of pregabalin, gabapentin and diclofenac sodium for prevention of succinylcholine-induced myalgia: A randomized, double-blinded study

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    C K Pandey

    2014-01-01

    Full Text Available Context: Succinylcholine a depolarizing muscle relaxant with rapid onset, predictable course and short duration of action is associated with myalgia. Aim: The aim of this study is to evaluate the efficacy of pregabalin, gabapentin and diclofenac on the incidence and severity of succinylcholine-induced myalgia. Settings and Design: Tertiary Care Teaching Hospital. Materials and Methods: A total of 120 patients undergoing laparoscopic cholecystectomy were randomly assigned into three groups: Pregabalin group received 150 mg of pregabalin, gabapentin group received 600 mg of gabapentin and diclofenac group received 100 mg of diclofenac sodium orally 2 h prior to surgery. Anesthesia was induced with fentanyl 3 μg/kg, propofol 2-2.5 mg/kg and succinylcholine 1.5 mg/kg and was maintained with oxygen with sevoflurane in the air and intermittent vecuronium bromide. A blinded observer recorded post-operative pain scores on visual analog scale at different time intervals and myalgia at 24 h. Post-operative pain relief was provided with fentanyl based patient-controlled analgesia. Fentanyl consumption in 24 h was recorded as a primary outcome. Statistical Analysis: Patients′ characteristics and total fentanyl consumption were compared using one-way ANOVA followed by post-hoc test. Pain score was compared amongst the groups using Kruskal Wallis test. Results: The myalgia occurred in 15, 14 and 13 patients in pregabalin, gabapentin and diclofenac sodium group respectively (P > 0.85. Patients in diclofenac group had significantly higher fentanyl consumption (674.85 ± 115.58 μg compared with pregabalin group (601.87 ± 129.57 μg (95% confidence interval [CI] = 34.8-120.7 and gabapentin group (612.29 ± 105.12 μg (95% CI = 14.9-170.5. However, there was no significant difference in fentanyl consumption between pregabalin and gabapentin groups (95% CI = −34.8-120.7. There was a significant difference in visual analog score at time points 12, 18 and 24 h

  17. 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

  18. Randomized, observer-blind, split-face study to compare the irritation potential of 2 topical acne formulations over a 14-day treatment period.

    Science.gov (United States)

    Ting, William

    2012-08-01

    This randomized, observer-blind, split-face study assessed the irritation potential and likelihood of continued use of clindamycin phosphate 1.2%--benzoyl peroxide (BPO) 2.5% gel or adapalene 0.1%--BPO 2.5% gel once daily over a 14-day treatment period in 21 participants (11 males; 10 females) with acne who were 18 years or older. Investigator clinical assessment (erythema and dryness) and self-assessment (dryness and burning/stinging) were performed at baseline and each study visit (days 1-14) using a 4-point scale (O = none; 3 = severe). Transepidermal water loss (TEWL) and corneometry measurements were performed at baseline and days 3, 5, 7, 9, 11, and 14. Lesions were counted at baseline and on day 14. Participant satisfaction questionnaires were completed on days 7 and 14. At the end of the study, investigators reported none or only mild erythema in 86% (18/21) of participants treated with clindamycin phosphate 1.2%--BPO 2.5% gel compared with 62% (13/21) of participants treated with adapalene 0.1%--BPO 2.5% gel. No severe erythema was reported with clindamycin phosphate 1.2%--BPO 2.5% gel. Adapalene 0.1%--BPO 2.5% gel was prematurely discontinued due to severe erythema in 1 participant on day 5 and a second participant on day 9. Additionally, 2 more participants reported severe erythema on day 14. Mean erythema scores were 0.9 (mean change from baseline, 0.7) with clindamycin phosphate 1.2%--BPO 2.5% gel and 1.4 (mean change from baseline, 1.3) with adapalene 0. 1%--BPO 2.5% gel on day 14 (P BPO 2.5% gel. Continued use and efficacy results for the treatment of acne were influenced by the potential of the product to cause irritation and the participant preferences. Irritation potential was more pronounced and severe with adapalene 0.1%--BPO 2.5% gel. Undoubtedly, as a result more participants preferred treatment with clindamycin phosphate 1.2%--BPO 2.5% gel and were more likely to continue to use the product.

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

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    Sampalis John S

    2012-04-01

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

  20. Double-blinded, randomized controlled trial comparing real versus placebo acupuncture to improve tolerance of diagnostic esophagogastroduodenoscopy without sedation: a study protocol

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    Plaschke K

    2011-02-01

    Full Text Available Abstract Background Sedation prior to performance of diagnostic esophagogastroduodenoscopy (EGDE is widespread and increases patient comfort. But 98% of all serious adverse events during EGDEs are ascribed to sedation. The S3 guideline for sedation procedures in gastrointestinal endoscopy published in 2008 in Germany increases patient safety by standardization. These new regulations increase costs because of the need for more personnel and a prolonged discharge procedure after examinations with sedation. Many patients have difficulties to meet the discharge criteria regulated by the S3 guideline, e.g. the call for a second person to escort them home, to resign from driving and working for the rest of the day, resulting in a refusal of sedation. Therefore, we would like to examine if an acupuncture during elective, diagnostic EGDEs could increase the comfort of patients refusing systemic sedation. Methods/Design A single-center, double blinded, placebo controlled superiority trial to compare the success rates of elective, diagnostic EGDEs with real and placebo acupuncture. All patients aged 18 years or older scheduled for elective, diagnostic EGDE who refuse a systemic sedation are eligible. 354 patients will be randomized. The primary endpoint is the rate of successful EGDEs with the randomized technique. Intervention: Real or placebo acupuncture before and during EGDE. Duration of study: Approximately 24 months. Discussion Organisation/Responsibility The ACUPEND - Trial will be conducted in accordance with the protocol and in compliance with the moral, ethical, and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989 and Good Clinical Practice (GCP. The Interdisciplinary Endoscopy Center (IEZ of the University Hospital Heidelberg is responsible for design and conduct of the trial, including randomization and documentation of patients' data. Data management and statistical analysis will be performed

  1. Does naftifine have anti-inflammatory properties? A double-blind comparative study with 1% clotrimazole/1% hydrocortisone in clinically diagnosed fungal infection of the skin.

    Science.gov (United States)

    Evans, E G; James, I G; Seaman, R A; Richardson, M D

    1993-10-01

    In a multicentre, double-blind, randomized, parallel group study in general practice, 269 patients with clinically diagnosed fungal infection of the skin were treated with either naftifine (Exoderil) or 1% clotrimazole plus 1% hydrocortisone (CHC; Canesten HC) applied twice daily for 4 weeks. Only 115 patients were shown subsequently to have a fungal infection by laboratory tests; the others had inflammatory disease of unknown aetiology. In those with fungal disease, both treatments were equally effective in terms of mycological cure (negative microscopy and culture). Clinical results for all 265 patients showed no clinically identifiable difference between the two preparations in terms of resolution of the disease, indicating that naftifine does have anti-inflammatory activity at least equal to CHC. This study suggests that there is no clinical advantage in treating patients with clinically diagnosed fungal infection of the skin with an antimycotic/corticosteroid combination as opposed to naftifine alone.

  2. Efficacy of frovatriptan in the acute treatment of menstrually related migraine: analysis of a double-blind, randomized, cross-over, multicenter, Italian, comparative study versus rizatriptan.

    Science.gov (United States)

    Savi, Lidia; Omboni, Stefano; Lisotto, Carlo; Zanchin, Giorgio; Ferrari, Michel D; Zava, Dario; Pinessi, Lorenzo

    2011-12-01

    The objectives of this study are to assess the efficacy and safety of frovatriptan, and rizatriptan in the subgroup of women with menstrually related migraine of a multicenter, randomized, double blind, cross-over study. Each patient received frovatriptan 2.5 mg or rizatriptan 10 mg in a randomized sequence: after treating 3 episodes of migraine in not more than 3 months with the first treatment, the patient had to switch to the other treatment. Menstrually related migraine was defined according to the criteria listed in the Appendix of the last IHS Classification of Headache disorders. 99 out of the 125 patients included in the intention-to-treat analysis of the main study were of a female gender: 93 had regular menstrual cycles and were, thus, included in this analysis. A total of 49 attacks classified as menstrually related migraine were treated with frovatriptan and 59 with rizatriptan. Rate of pain relief at 2 h was 58% for frovatriptan and 64% for rizatriptan (p = NS), while rate of pain free at 2 h was 31 and 34% (p = NS), respectively. At 24 h, 67 and 81% of frovatriptan-treated, and 61 and 74% of rizatriptan-treated patients were pain free and had pain relief, respectively (p = NS). Recurrence at 24 h was significantly (p rizatriptan). Frovatriptan was as effective as rizatriptan in the immediate treatment of menstrually related migraine attacks while showing a favorable sustained effect with a lower rate of migraine recurrence. These results need to be confirmed by randomized, double-blind, prospective, large clinical trials.

  3. Iodixanol Has a Favourable Fibrinolytic Profile Compared to Iohexol in Cardiac Patients Undergoing Elective Angiography: A Double-Blind, Randomized, Parallel Group Study.

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    Andrew T Treweeke

    Full Text Available There is no consensus and a limited evidence base for choice of contrast agents (CA in angiography. This study evaluated the impact of iohexol and iodixanol CA on fibrinolytic factors (tissue plasminogen activator [t-PA] and plasminogen activator inhibitor-1 [PAI-1], as well as platelet-monocyte conjugates in cardiac patients undergoing elective angiography in a double-blind, randomised parallel group study.Patients (men, 50-70 years old; n = 12 were randomised to receive either iohexol (Omnipaque; n = 6 or iodixanol (Visipaque; n = 6 during elective angiography at Raigmore Hospital, Inverness, UK. Arterial and venous blood samples were drawn prior to CA delivery and following angiography. Assessment of platelet-monocyte conjugation, t-PA and PAI-1 antigen and activity was conducted in samples pre- and post-angiography.Plasma t-PA antigen was depressed equally in the study groups after angiography, but there was a greater reduction in PAI-1 antigen in the group receiving iodixanol. These findings corresponded to a substantial reduction in t-PA activity in patients receiving iohexol, with no change in those receiving iodixanol (P = 0.023 between the CA groups. Both CAs caused a reduction in platelet-monocyte conjugation, with no difference between the groups. No adverse events were reported during the trial.Avoiding reduced plasma t-PA activity might be an important consideration in choosing iodixanol over iohexol in patients at risk of thrombosis following angiography. The trial is registered on the ISRCTN register (ISRCTN51509735 and funded by the Coronary Thrombosis Trust and National Health Service (Highland R&D Endowments. The funders had no influence over study design or reporting.Controlled-Trials.com ISRCTN51509735.

  4. COMPARATIVE STUDY BETWEEN INTRATHECAL BUPIVACAINE WITH DEXMEDETOMIDINE AND INTRATHECAL BUPIVACAINE WITH FENTANYL FOR LOWER ABDOMINAL SURGERIES. A RANDOMIZED DOUBLE BLINDED CONTROLLED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    Leelavathy

    2016-05-01

    Full Text Available BACKGROUND Spinal anaesthesia is preferred choice of anaesthesia in lower abdominal surgeries since long time. Various adjuvants have been used with local anaesthetics in spinal anaesthesia to provide prolonged postoperative analgesia. Dexmedetomidine, the new highly selective α2-agonist drug, is now being used as a neuraxial adjuvant. This prospective, randomized, double blinded study was conducted to evaluate the onset, duration of sensory and motor blockade, haemodynamic stability and adverse effects of dexmedetomidine and fentanyl when given intrathecally with 0.5% hyperbaric bupivacaine. MATERIALS AND METHODS A total of 60 patients of ASA I and II scheduled for elective lower abdominal surgeries were selected and randomly allocated into 2 groups of 30 each. Group D received 0.5% hyperbaric bupivacaine (15 mg plus dexmedetomidine (10 μg, Group F received 0.5% hyperbaric bupivacaine (15 mg plus 25 μg fentanyl intrathecally. The onset of sensory andmotor blockade, duration of sensory and motor blockade, duration of analgesia, haemodynamic changes and side effects (Nausea, vomiting, pruritus, respiratory depression, bradycardia or hypotension were recorded. RESULTS Onset of sensory blockade was faster in fentanyl group than dexmedetomidine group, but this was statistically insignificant. Patients in dexmedetomidine group (D had faster motor onset (p<0.01 and significantly longer sensory and motor blockade time than patients in fentanyl group (F (p<0.01. Duration of analgesia was better with dexmedetomidine (p<0.01. There were no significant haemodynamic changes or adverse effects in any of the groups. It was observed that sedation was better in Group D. CONCLUSIONS Intrathecal Dexmedetomidine is a better adjuvant than intrathecal Fentanyl with prolonged sensory and motor blockade and profound postoperative analgesia.

  5. A PROSPECTIVE, DOUBLE BLIND RANDOMIZED CONTROLLED STUDY COMPARING THE EFFECTS OF MAGNESIUM SULPHATE VERSUS CLONIDINE AS AN ADJUNCT TO BUPIVICAINE IN SUB UMBILICAL SURGERIES

    Directory of Open Access Journals (Sweden)

    Sadhana

    2015-07-01

    Full Text Available OBJECTIVE: Providing comfort to the patient by prevention/relief of pain using various combinations of drugs thus achieving maximal benefit with minimal adverse effects is the ultimate goal of the anesthesiologist in the peri - operative period. AIM OF STUDY: To eva luate the efficacy of Magnesium Sulphate Versus Clonidine as an adjunct to Bupivicaine in Epidural Analgesia. METHODS: A total of 90 patients of either gender with ASA Grade (I , II , aged between 18 to 60 years scheduled for elective sub umbilical surgeri es were randomly assigned in a prospective double blind study to three separate groups that received epidural 0.5% Bupivicaine (19ml with 1ml of 0.9% Normal Saline or 0.5% Bupivicaine (19ml with Magnesium sulphate 50mg (1ml or 0.5% Bupivicaine With Clon idine 150 micro gram (1ml. All Patients were administered Pre - medication as per Hospital Protocol night before and morning of Surgery. Intra operative monitoring of patients included Heart - rate , ECG , SPO2 , NIBP , RR as a Base Line and follow - up after Injec tion of assigned drug. Sensory blockade was evaluated by using bilateral pinprick method , motor blockade was estimated using modified Bromage scale at 5 , 10 , 15 , 20 , 25 and 30 Minutes Interval after Epidural Administration of drug. Pain perceived was asses sed with Visual Analog Scale (VAS 0 - 10 both Intra Operatively and Post Operatively. In the event of pain with VAS >5 , top - up of 0.5% Bupivicaine alone was added. The time from onset of blockade till need for 1st top - up was evaluated. CONCLUSION: Co - ad ministration of Magnesium Sulphate (50mg to Epidural 0.5% Bupivicaine provides a predictable and rapid onset of nerve blockade without any side effects whereas co - administration of clonidine (150 micro - grams to Epidural 0.5% Bupivacaine produced prolonge d duration of anesthesia. The use of adjuvants in Epidural Aneasthesia gives a scope to improve the quality of anesthesia while minimizing the adverse

  6. Fear of blindness and perceptions about blind people. The Andhra Pradesh Eye Disease Study.

    Science.gov (United States)

    Giridhar, Pyda; Dandona, Rakhi; Prasad, Mudigonda N; Kovai, Vilas; Dandona, Lalit

    2002-09-01

    This study assessed the fear of being affected by illness and disability including blindness, and perceptions of the population towards blind people in the Indian state of Andhra Pradesh. A total of 11,786 subjects of all ages were sampled from 94 clusters in one urban and three rural study areas of Andhra Pradesh using stratified, random, cluster, systematic sampling to represent the population of this state. A total of 10,293 subjects of all ages underwent a detailed interview and dilated ocular evaluation. Subjects > 15 years of age (7,432) were interviewed regarding fear of illness/disability and their perceptions of blind people. The fear of blindness was assessed in comparison to cancer, severe mental illness, heart attack, losing limbs, deafness, inability to speak, and paralysis. A majority of the study population feared all the illnesses and disabilities assessed. The prevalence of fear of blindness was 90.9% (95% confidence interval 89.1-92.8%) and 92.1% (95% confidence interval 90.6-93.6%) in urban and rural study areas respectively. With multiple logistic regression the fear of blindness was significantly higher for those with any level of education and for those living in the rural study areas. The proportion of those having positive feelings towards blind people was higher in the urban study area. A high prevalence of blindness, 1.84%, has been reported in this population previously. These data suggest that this population feared blindness, and yet there is a high rate of blindness. This reflects the need for increasing awareness about blindness in this population through eye health promotion strategies in order to reduce blindness, and awareness regarding the availability of rehabilitation services.

  7. Kojic acid vis-a-vis its combinations with hydroquinone and betamethasone valerate in melasma: A randomized, single blind, comparative study of efficacy and safety

    Directory of Open Access Journals (Sweden)

    Kirti S Deo

    2013-01-01

    Strict photoprotection and use of a SPF 15 sunscreen was advised during the day. Patients were evaluated every 2 weeks and a fall in MASI score was calculated at the end of the study period of 12 weeks by the same investigator. Results: The response was compared according to percentage decrease in MASI score. Efficacy was evaluated among the groups at the end of 3 months using bivariate analysis and calculated by using the paired ′t′ test. The clinical efficacy of group B was the highest followed closely by group D and group A, that of group C being the lowest. Conclusion: Kojic acid in synergy with hydroquinone is a superior depigmenting agent as compared with other combinations.

  8. A double blind placebo controlled group comparative study of ophthalmic sodium cromoglycate and nedocromil sodium in the treatment of vernal keratoconjunctivitis.

    Science.gov (United States)

    el Hennawi, M

    1994-05-01

    In a 4 week double masked comparative study, patients received 2% nedocromil sodium (48), 2% sodium cromoglycate (48), or placebo eye drops (42), four times daily, for the treatment of vernal keratoconjunctivitis (VKC). Clinical examinations of eye condition and symptom severity were made before and after a 1 week baseline before starting test treatment, and after 1, 2, and 4 weeks of treatment. Patients kept daily diary card records of symptom severity and concomitant therapy. At the clinic, significant improvements were seen with both active treatments after 2-4 weeks. During the final visit, significant benefits over placebo were recorded for five ocular signs with nedocromil sodium and three with sodium cromoglycate, bulbar and lower tarsal chemosis being better controlled by nedocromil sodium (p sodium cromoglycate). Diary card trends showed improvement with all three treatments, which was greatest with nedocromil sodium and least with placebo. Compared with placebo, both the active drugs produced statistically significant improvements in general eye condition during weeks 1-2, and nedocromil sodium significantly reduced itching within the first week. Overall, nedocromil sodium had the greatest effect on symptoms, although diary card data revealed no statistically significant differences between the two active drugs. In conclusion, both 2% nedocromil sodium and 2% sodium cromoglycate were effective in controlling VKC when administered four times daily into the eyes, while the marked anti-inflammatory activity of nedocromil sodium was apparent in its more pronounced overall therapeutic effect.

  9. Pulsed dye laser versus long pulsed Nd:YAG laser in the treatment of angiokeratoma of Fordyce: A randomized, comparative, observer-blinded study.

    Science.gov (United States)

    Ibrahim, S M

    2016-01-01

    Angiokeratoma of Fordyce is typically asymptomatic, blue-to-red papules with a scaly surface located on the scrotum, shaft of penis or labia majora. They can be treated with some locally destructive treatment modalities such as excision, electrocoagulation, cryotherapy and laser. To compare the effects of the pulsed dye laser versus long pulsed Nd:YAG laser in the treatment of angiokeratoma of Fordyce. Twenty tow patients with angiokeratoma of Fordyce were included in this study. All participants received three sessions of pulsed dye laser on the selected side or part of lesional area and long pulsed Nd:YAG laser on the other side or part of lesional area. Two dermatologists independently evaluated the photographs of the baseline and two-month follow-up after last session using a grade system in which treatment response was categorized into six grades. Both PDL and long pulsed Nd:YAG laser revealed statistically significant improvements in angiokeratoma of fordyce. Comparatively, there was a statistical difference between them (overall mean improvement with PDL, 61.8%, versus Nd:YAG, 77.63%; p laser are effective and safe in the treatment of angiokeratoma of Fordyce with better response in Nd:YAG laser than pulsed dye laser.

  10. 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.

  11. Halobetasol Propionate Lotion, 0.05% Provides Superior Hydration Compared to Halobetasol Propionate Cream, 0.05% in a Double-Blinded Study of Occlusivity and Hydration.

    Science.gov (United States)

    Grove, Gary; Zerweck, Charles; Houser, Tim; Andrasfay, Anthony; Gauthier, Bob; Holland, Charles; Piacquadio, Daniel

    2017-02-01

    This study measured skin hydration and occlusivity of two test products [halobetasol propionate lotion, 0.05% (HBP Lotion) and Ultravate® (halobetasol propionate) cream, 0.05% (HBP Cream)] at 2, 4, and 6 hours after application to skin test sites previously challenged by dry shaving, which was performed to compromise the integrity of the stratum corneum barrier. Trans-epidermal water loss (TEWL), an indicator of skin barrier function, was measured using cyberDERM, inc. RG-1 evaporimeter. Skin hydration was evaluated using IBS SkiCon-200 conductance meter. Test products were applied bilaterally on dry-shaved sites on the volar forearm sites, according to a randomization scheme, with two test sites untreated to serve as "dry-shaved" controls. TEWL and conductance were measured at 2, 4, and 6 hours post-treatment. HBP Lotion displayed a significant increase in skin hydration at 2, 4, and 6 hours post-treatment compared to the baseline values and dry-shaved controls (each, P less than 0.001). However, HBP Cream produced statistically significant increased skin hydration only after 6 hours (P less than 0.05). HBP Lotion was significantly more effective than HBP Cream in increasing skin hydration at 2 and 4 hours post-treatment (each, P less than 0.001), and had a directional advantage (not statistically significant) at 6 hours. Neither test product had a significant occlusive effect as measured by TEWL at 2, 4, and 6 hours post-application. Both formulations of HBP (Lotion and Cream) contributed to skin moisturization, as measured by skin conductance. HBP Lotion produced a significantly more rapid onset and higher level of moisturization at 2 and 4 hours post-application compared to HBP Cream. The TEWL results indicate that neither HBP Lotion nor HBP Cream provided any significant occlusivity to the skin. J Drugs Dermatol. 2017;16(2):140-144..

  12. 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

  13. Efficacy and tolerability of a polysaccharide-resin-honey based cough syrup as compared to carbocysteine syrup for children with colds: a randomized, single-blinded, multicenter study

    National Research Council Canada - National Science Library

    Cohen, Herman Avner; Hoshen, Moshe; Gur, Shmuel; Bahir, Arie; Laks, Yoseph; Blau, Hannah

    2017-01-01

    .... The objective of this trial is to compare the effects of a polysaccharide-resin-honey based cough syrup, and carbocysteine syrups on nocturnal and daytime cough associated with childhood upper...

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

    DEFF Research Database (Denmark)

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

    1993-01-01

    The objective of the study was to evaluate the efficacy and safety of indobufen compared with placebo in the treatment of moderately severe intermittent claudication. The study consisted of a four-week single-blind, placebo-controlled run-in phase, followed by a six-month double-blind randomized ...

  15. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study

    Science.gov (United States)

    Yoo, Dae Hyun; Hrycaj, Pawel; Miranda, Pedro; Ramiterre, Edgar; Piotrowski, Mariusz; Shevchuk, Sergii; Kovalenko, Volodymyr; Prodanovic, Nenad; Abello-Banfi, Mauricio; Gutierrez-Ureña, Sergio; Morales-Olazabal, Luis; Tee, Michael; Jimenez, Renato; Zamani, Omid; Lee, Sang Joon; Kim, HoUng; Park, Won; Müller-Ladner, Ulf

    2013-01-01

    Objectives To compare the efficacy and safety of innovator infliximab (INX) and CT-P13, an INX biosimilar, in active rheumatoid arthritis patients with inadequate response to methotrexate (MTX) treatment. Methods Phase III randomised, double-blind, multicentre, multinational, parallel-group study. Patients with active disease despite MTX (12.5–25 mg/week) were randomised to receive 3 mg/kg of CT-P13 (n=302) or INX (n=304) with MTX and folic acid. The primary endpoint was the American College of Rheumatology 20% (ACR20) response at week 30. Therapeutic equivalence of clinical response according to ACR20 criteria was concluded if the 95% CI for the treatment difference was within ±15%. Secondary endpoints included ACR response criteria, European League Against Rheumatism (EULAR) response criteria, change in Disease Activity Score 28 (DAS28), Medical Outcomes Study Short-Form Health Survey (SF-36), Simplified Disease Activity Index, Clinical Disease Activity Index, as well as pharmacokinetic (PK) and pharmacodynamic (PD) parameters, safety and immunogenicity. Results At week 30, ACR20 responses were 60.9% for CT-P13 and 58.6% for INX (95% CI −6% to 10%) in the intention-to-treat population. The proportions in CT-P13 and INX groups achieving good or moderate EULAR responses (C reactive protein (CRP)) at week 30 were 85.8% and 87.1%, respectively. Low disease activity or remission according to DAS28–CRP, ACR–EULAR remission rates, ACR50/ACR70 responses and all other PK and PD endpoints were highly similar at week 30. Incidence of drug-related adverse events (35.2% vs 35.9%) and detection of antidrug antibodies (48.4% vs 48.2%) were highly similar for CT-P13 and INX, respectively. Conclusions CT-P13 demonstrated equivalent efficacy to INX at week 30, with a comparable PK profile and immunogenicity. CT-P13 was well tolerated, with a safety profile comparable with that of INX. ClinicalTrials.gov Identifier NCT01217086 PMID:23687260

  16. Postoperative pain relief after surgical removal of impacted third molars: a single-blind, randomized, controlled study to compare levobupivacaine and mepivacaine.

    Science.gov (United States)

    Crincoli, Vito; Di Bisceglie, Maria Beatrice; Massaro, Maria; Giuliani, Rocco; Favia, Gianfranco; Brienza, Nicola

    2009-01-01

    To compare the efficacy of 0.75% levobupivacaine with that of 3% mepivacaine for pain control after surgical removal of impacted mandibular third molars. Forty-two subjects (23 females and 19 males, mean age 23.5 +/- 4) underwent surgical removal of third molars in two separate sessions. Within each patient, levobupivacaine was used to anesthetize one extraction side and for the other side, mepivacaine. Onset of anesthesia, duration of surgery, lip numbness, timing of pain appearance and analgesic consumption were evaluated. There were no significant differences in onset of anesthesia, duration of surgical procedure, and lower lip numbness between the two groups (P > .05). Timing of pain appearance and of first drug consumption was significantly lower in the mepivacaine group (P mepivacaine anesthesia. Levobupivacaine is a valid alternative to traditional local anesthetics for surgical removal of lower third molars. It presents better pain relief when compared to mepivacaine in the immediate postoperative period as evidenced by lower VAS scores.

  17. Time to onset of analgesia and analgesic efficacy of effervescent acetaminophen 1000 mg compared to tablet acetaminophen 1000 mg in postoperative dental pain: a single-dose, double-blind, randomized, placebo-controlled study.

    Science.gov (United States)

    Møller, P L; Nørholt, S E; Ganry, H E; Insuasty, J H; Vincent, F G; Skoglund, L A; Sindet-Pedersen, S

    2000-04-01

    This randomized, double-blind, placebo-controlled study compared the time to onset of analgesia and the analgesic efficacy of two formulations of acetaminophen 1000 mg--an effervescent solution and tablet--in 242 patients with moderate or severe pain following dental surgery. Onset of analgesia was determined using a two-stopwatch procedure. Analgesia was assessed over a 4-hour period. Treatments were compared using standard indexes of pain intensity and pain relief and summary measures. Both acetaminophen formulations were significantly more effective than their corresponding placebo for all efficacy assessments. The median time to onset of analgesia was significantly shorter with effervescent acetaminophen (20 minutes) compared to tablet acetaminophen (45 minutes). During the first 45 minutes after administration, effervescent acetaminophen was significantly more effective at each scheduled assessment time than tablet acetaminophen. The median time to meaningful pain relief was significantly shorter with effervescent acetaminophen (45 minutes) compared to tablet acetaminophen (60 minutes). At 4 hours after administration, the pain relief was significantly better with tablet acetaminophen than with effervescent acetaminophen. No other significant differences were observed between the active treatments. In conclusion, effervescent acetaminophen produces a significantly faster onset of analgesia than tablet acetaminophen.

  18. Double-Blind, Placebo-Controlled, Randomized Study Comparing 0.0003% Calcitriol with 0.1% Tacrolimus Ointments for the Treatment of Endemic Pityriasis Alba

    Directory of Open Access Journals (Sweden)

    Berenice Moreno-Cruz

    2012-01-01

    Full Text Available Background. Pityriasis alba (PA is a frequent cause of consultation in tropical areas due to its chronic course, frequent relapses, and notorious hypopigmented lesions in pediatric dark skin populations. Currently, no treatment is widely accepted. Objective. To assess the efficacy of 0.0003% calcitriol and 0.1% tacrolimus ointments compared with placebo in the treatment of endemic PA. Methods. Twenty-eight children aged 3–17 years with 56 symmetrical lesions and phototype IV-V, were randomly assigned to receive the treatments on target lesions on the face. Improvement was evaluated at baseline and 8 weeks later clinically and by digital quantification of the affected area, colorimetry, and transepidermal water loss (TEWL. Results. Tacrolimus and calcitriol ointments induced a mean improvement of 68%, compared to 44% of placebo. We found an elevated TEWL in PA lesions. In the treated plaques, the reduction of the affected area was associated with improvement of pigmentation and TEWL. Conclusions. Calcitriol and tacrolimus induced similar repigmentation in endemic PA lesions. Melanogenic, anti-inflammatory, and barrier defect restoration properties of these drugs may explain these findings.

  19. A prospective randomized double blind study to compare dexmedetomidine and midazolam in ear nose and throat surgery for monitored anesthesia care

    Directory of Open Access Journals (Sweden)

    Manmath A. Delmade

    2016-08-01

    Results: The drop in HR and MBP from pre-operative value was observed at various intervals during the surgery and also in the recovery in both the groups but it was significant in group D (P<0.005. Patient satisfaction was significantly better with dexmedetomidine compared to midazolam (p=0.0001. There were no side effects in both of the groups except for bradycardia in group D which was reversed easily with injection atropine. Conclusions: Dexmedetomidine promises to be a suitable alternative to midazolam with added advantage of better patient satisfaction and faster recovery, but with close monitoring of hemodynamics. [Int J Res Med Sci 2016; 4(8.000: 3159-3163

  20. A Randomized Double-Blind Placebo-Controlled Study to Compare Preemptive Analgesic Efficacy of Novel Antiepileptic Agent Lamotrigine in Patients Undergoing Major Surgeries.

    Science.gov (United States)

    Shah, Priyank; Bhosale, Uma A; Gupta, Ankush; Yegnanarayan, Radha; Sardesai, Shalini

    2016-02-01

    If postoperative acute pain remains unrelieved, it may result in significant morbidity and mortality. Preemptive analgesic initiated before surgery offers premature analgesia even before exposure to an initial noxious stimulus bestowing effective postoperative analgesia. In developed countries, it is regularly practiced as a part of well-defined protocol. In our country however, only a few centers practice it and that too irregularly and with undefined protocol. Few studies support preemptive analgesic efficacy of novel antiepileptic agent gabapentin. Though lamotrigine is a proven analgesic in animal models of chronic pain and clinical studies of gabapentin-resistant neuropathic pain, a literature search revealed scarce data on its preemptive analgesic efficacy. The present study is designed to study the preemptive analgesic efficacy of lamotrigine in comparison with diclofenac sodium in postoperative pain control. This randomized clinical trial included 90 patients of both sexes, between 18 years and 70 years undergoing major surgeries. Patients were randomly allocated into placebo, control, and test groups and received the respective treatment 30 min before the induction of anesthesia. Aldrete score and pain score were recorded using visual analog scale (VAS), facial rating scale (FRS), and behavioral rating scale (BRS) at awakening and at 1 h, 2 h, 4 h, 6 h, and 24 h. Postoperative rescue analgesic consumption for 24 h was recorded. Significantly higher pain scores were observed in the placebo group postoperatively for 2 h on all pain scales (P < 0.05), whereas in the control group it was significantly higher at 1 h (P < 0.05). The test group patients were more comfortable throughout the study and postoperative analgesic requirement was significantly less (P < 0.05). The study recommends the use of single oral dose lamotrigine as preemptive analgesic for effective postoperative pain control.

  1. A randomized double-blind placebo-controlled study to compare preemptive analgesic efficacy of novel antiepileptic agent lamotrigine in patients undergoing major surgeries

    Directory of Open Access Journals (Sweden)

    Priyank Shah

    2016-01-01

    Full Text Available Background: If postoperative acute pain remains unrelieved, it may result in significant morbidity and mortality. Preemptive analgesic initiated before surgery offers premature analgesia even before exposure to an initial noxious stimulus bestowing effective postoperative analgesia. In developed countries, it is regularly practiced as a part of well-defined protocol. In our country however, only a few centers practice it and that too irregularly and with undefined protocol. Few studies support preemptive analgesic efficacy of novel antiepileptic agent gabapentin. Though lamotrigine is a proven analgesic in animal models of chronic pain and clinical studies of gabapentin-resistant neuropathic pain, a literature search revealed scarce data on its preemptive analgesic efficacy. Aims: The present study is designed to study the preemptive analgesic efficacy of lamotrigine in comparison with diclofenac sodium in postoperative pain control. Materials and Methods: This randomized clinical trial included 90 patients of both sexes, between 18 years and 70 years undergoing major surgeries. Patients were randomly allocated into placebo, control, and test groups and received the respective treatment 30 min before the induction of anesthesia. Aldrete score and pain score were recorded using visual analog scale (VAS, facial rating scale (FRS, and behavioral rating scale (BRS at awakening and at 1 h, 2 h, 4 h, 6 h, and 24 h. Postoperative rescue analgesic consumption for 24 h was recorded. Results: Significantly higher pain scores were observed in the placebo group postoperatively for 2 h on all pain scales (P < 0.05, whereas in the control group it was significantly higher at 1 h (P < 0.05. The test group patients were more comfortable throughout the study and postoperative analgesic requirement was significantly less (P < 0.05. Conclusions: The study recommends the use of single oral dose lamotrigine as preemptive analgesic for effective postoperative pain

  2. 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.

  3. 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

    2015-01-01

    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 th

  4. Cetuximab plus platinum-based chemotherapy in head and neck squamous cell carcinoma: a randomized, double-blind safety study comparing cetuximab produced from two manufacturing processes using the EXTREME study regimen.

    Science.gov (United States)

    Soulières, Denis; Aguilar, Jose Luis; Chen, Eric; Misiukiewicz, Krzysztof; Ernst, Scott; Lee, Hyun Jung; Bryant, Katherine; He, Shuang; Obasaju, Coleman K; Chang, Shao-Chun; Chin, Steve; Adkins, Douglas

    2016-01-14

    Cetuximab, in combination with platinum chemotherapy plus 5-fluoruracil (5-FU), is approved for the first-line treatment of recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN). Cetuximab manufactured by ImClone (US commercial cetuximab) potentially results in higher systemic exposures than cetuximab manufactured by Boehringer Ingelheim (BI-manufactured cetuximab). This prospective, randomized, double-blind study compared the safety profiles of the two cetuximab formulations. Patients with previously untreated locoregionally recurrent and/or metastatic SCCHN were randomly assigned to receive the same dose of US commercial cetuximab (Arm A) or BI-manufactured cetuximab (Arm B), each in combination with cisplatin or carboplatin plus 5-FU. The primary outcome was all-grade, all-cause treatment-emergent adverse events (TEAEs). The majority of patients experienced ≥ 1 TEAE, regardless of causality (Arm A: 75/77 patients, 97.4%; Arm B: 68/71 patients, 95.8%). TEAEs with the highest incidence included nausea, fatigue, and hypomagnesemia in both arms. The absolute risk difference between the two arms for patients experiencing at least one adverse event (AE) was 0.029 (p = 0.281, 95% confidence interval [CI]: -0.024, 0.082) for AEs regardless of causality and 0.005 (p = 0.915, 95% CI: -0.092, 0.103) for AEs possibly related to study drug. There were no significant differences between the two arms in the incidence of acneiform rash, cardiac events, infusion reactions, or hypomagnesemia. Overall survival, progression-free survival, and overall response rates were similar in the two arms. There were no clinically meaningful differences in safety between US commercial cetuximab and BI-manufactured cetuximab in combination with platinum-based therapy with 5-FU in patients with locoregionally recurrent and/or metastatic SCCHN. The use of US commercial cetuximab in this combination chemotherapy regimen did not result in any unexpected safety signals. The

  5. 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

    2013-01-01

    Objectives 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). Methods 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. Results 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. Conclusions 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. PMID:23687259

  6. Efficacy of desvenlafaxine 50 mg compared with placebo in patients with moderate or severe major depressive disorder: a pooled analysis of six randomized, double-blind, placebo-controlled studies.

    Science.gov (United States)

    Papakostas, George I; Culpepper, Larry; Fayyad, Rana S; Musgnung, Jeff; Guico-Pabia, Christine J

    2013-11-01

    This study assessed the efficacy of desvenlafaxine 50 mg/day compared with placebo for treating moderate or severe major depressive disorder (MDD). Data were pooled from six double-blind, placebo-controlled, desvenlafaxine 50 mg/day fixed-dose studies in adults with MDD. The primary endpoint was improvement in 17-item Hamilton Rating Scale for Depression (HAM-D17) scores from baseline at week 8. HAM-D17 changes were evaluated in patients with moderate (18desvenlafaxine 50 mg, n=1150; placebo, n=1039). Of those, 694 (32%) patients had severe depression at baseline. Desvenlafaxine improved HAM-D17 scores versus placebo in patients with either moderate [desvenlafaxine, adjusted mean (±SE), -10.26±0.24; placebo, -8.87±0.26; Pdesvenlafaxine, -11.91±0.40; placebo, -9.85±0.42; Pdesvenlafaxine treatment compared with placebo (all P's≤0.029). Results were similar when baseline severity was defined by Montgomery-Åsberg Depression Rating Scale or Sheehan Disability Scale scores. Desvenlafaxine 50 mg/day significantly improved depressive symptoms regardless of severity at baseline and was effective in treating both moderate and severe MDD.

  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

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    Hannah Retallick-Brown

    2016-12-01

    Full Text Available 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. A phase 2, randomized, double-blind, multicenter study comparing siltuximab plus best supportive care (BSC) with placebo plus BSC in anemic patients with International Prognostic Scoring System low- or intermediate-1-risk myelodysplastic syndrome.

    Science.gov (United States)

    Garcia-Manero, Guillermo; Gartenberg, Gary; Steensma, David P; Schipperus, Martin R; Breems, Dimitri A; de Paz, Raquel; Valcárcel, David; Kranenburg, Britte; Reddy, Manjula; Komrokji, Rami S

    2014-09-01

    Interleukin-6 (IL-6) may play an important role in the pathophysiology of anemia of inflammation associated with myelodysplastic syndrome (MDS). This double-blind, placebo-controlled, phase 2 study assessed the efficacy and safety of siltuximab, a chimeric anti-IL-6 monoclonal antibody, in patients with low- and intermediate-1-risk MDS who require transfusions for MDS anemia. Patients were randomized in a 2:1 ratio to siltuximab 15 mg kg(-1) every 4 weeks + best supportive care (BSC) or placebo + BSC for 12 weeks. The primary endpoint was reduction in red blood cell (RBC) transfusions to treat MDS anemia, defined as ≥50% relative decrease and ≥2-unit absolute decrease in RBC transfusions. Fifty and 26 patients were randomized to the siltuximab and placebo groups, respectively. The study did not meet its prespecified hypothesis, with six (12%) patients in the siltuximab group and one (3.8%) in the placebo group having reductions in RBC transfusions (P = 0.271). At the time of the planned futility analysis, the prespecified cutoff criteria were not met, and the study was terminated early due to lack of efficacy. No unexpected safety findings were observed. In conclusion, compared to placebo, treatment with siltuximab did not reduce RBC transfusions in transfusion-dependent patients with low- and intermediate-1-risk MDS. Future studies might explore siltuximab in patients with less iron overload and with elevated IL-6 levels and/or using higher doses for MDS.

  9. A randomized, rater-blinded, crossover study comparing the clinical efficacy of Ritalin(®) LA (methylphenidate) treatment in children with attention-deficit hyperactivity disorder under different breakfast conditions over 2 weeks.

    Science.gov (United States)

    Schulz, Eberhard; Fleischhaker, Christian; Hennighausen, Klaus; Heiser, Philip; Haessler, Frank; Linder, Martin; Stollhoff, Kirsten; Warnke, Andreas; Baier, Monika; Klatt, Jan

    2010-11-01

    Several extended-release methylphenidate medications are available for treatment of children with ADHD. Pharmacokinetic investigations suggest that the serum levels of methylphenidate are partially altered when the medication is taken without breakfast. Clinical data comparing different breakfast situations are missing. In this study, different breakfast compositions and their influence on treatment with Ritalin LA are investigated. A total of 150 patients were enrolled in a rater-blinded, randomized crossover trial that compared a minimal breakfast with a standard breakfast in patients under stable treatment with Ritalin LA. Ratings for clinical efficacy were carried out after 1 week by teachers and parents (FBB-ADHS), as well as physicians (CGI). Additionally, a math test was administered to the patients. Of the total patients, 144 finished the trial with a breakfast compliance of 93%. All of the clinical rating scales showed consistently no difference between the two breakfast conditions. Non-inferiority of minimal breakfast versus standard breakfast was shown to be statistically significant (FBB-AHDS(Teacher): 0.97 with minimal breakfast, 1.01 with standard breakfast, P Ritalin LA is not influenced by breakfast and works independently of food intake.

  10. Comparative study of the efficacy and safety between blonanserin and risperidone for the treatment of schizophrenia in Chinese patients: A double-blind, parallel-group multicenter randomized trial.

    Science.gov (United States)

    Li, Huafang; Yao, Chen; Shi, Jianguo; Yang, Fude; Qi, Shuguang; Wang, Lili; Zhang, Honggeng; Li, Jie; Wang, Chuanyue; Wang, Chuansheng; Liu, Cui; Li, Lehua; Wang, Qiang; Li, Keqing; Luo, Xiaoyan; Gu, Niufan

    2015-10-01

    This randomized, double-blind study compared the efficacy and safety of blonanserin and risperidone to treat Chinese schizophrenia patients aged ≥18 and blonanserin or risperidone using a gradual dose-titration method (blonanserin tablets: 8-24 mg/day; risperidone tablets: 2-6 mg/day), twice daily. Treatment populations consisted of 128 blonanserin-treated patients and 133 risperidone-treated patients. Intention-to-treat analysis was performed using the last observation carried forward method. Reductions of PANSS total scores by blonanserin and risperidone treatment were -30.59 and -33.56, respectively. Risperidone treatment was associated with elevated levels of serum prolactin (67.16% risperidone versus 52.31% blonanserin) and cardiac-related abnormalities (22.39% risperidone versus 12.31% blonanserin), and blonanserin patients were more prone to extrapyramidal side effects (48.46% blonanserin versus 29.10% risperidone). In conclusion, blonanserin was as effective as risperidone for the treatment of Chinese patients with schizophrenia. The overall safety profiles of these drugs are comparable, although blonanserin was associated with a higher incidence of EPS and risperidone was associated with a higher incidence of prolactin elevation and weight gain. Thus, blonanserin is useful for the treatment of Chinese schizophrenia patients. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  11. A Multicenter, Prospective, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Saroglitazar 2 and 4 mg Compared to Pioglitazone 45 mg in Diabetic Dyslipidemia (PRESS V).

    Science.gov (United States)

    Pai, Vikas; Paneerselvam, A; Mukhopadhyay, Satinath; Bhansali, Anil; Kamath, Dinesh; Shankar, V; Gambhire, Dhiraj; Jani, Rajendrakumar H; Joshi, Shashank; Patel, Pankaj

    2014-01-01

    Dual PPARα/γ can improve both metabolic effects and minimized the side effects caused by either PPARα or PPARγ agonist. The PRESS V study was aimed to evaluate the safety, tolerability, and efficacy of saroglitazar 2 mg and 4 mg capsules (Lipaglyn™; Zydus Code: ZYH1) as compared to high dose pioglitazone in patients with diabetic dyslipidemia. In this 26-week double-blind, parallel arm, phase 3 study patients with hypertriglyceridemia with type 2 diabetes mellitus (BMI > 23 kg/m(2); hypertriglyceridemia: TG > 200 to 400 mg/dL; glycosylated hemoglobin [HbA1c] >7 to 9%) were enrolled from 14 sites in India. After 2 weeks of lifestyle modification, 122 patients were randomized double-blind to 24-week treatment with the study drugs (saroglitazar 2 mg or 4 mg or pioglitazone 45 mg once daily) in a 1:1:1 ratio. The primary end point was change in plasma triglyceride level at week 24. The secondary end points were change in lipid profile and fasting plasma glucose at week 24. Patients who received study medication and had undergone at least 1 postbaseline efficacy evaluation were included in the efficacy analysis. All randomized patients who received at least a single dose were included for safety evaluation. The efficacy analysis included 109 patients (n = 37 in saroglitazar 2 mg; n = 39 in saroglitazar 4 mg; n = 33 in pioglitazone). Saroglitazar 2 mg and 4 mg significantly reduced (P pioglitazone -15.5% (absolute change ± SD: -33.3 ± 162.41 mg/dL) at week 24. Saroglitazar 4 mg treatment also demonstrated marked decrease in low-density lipoprotein (5%), very-low-density lipoprotein (45.5%), total cholesterol (7.7%), and apolipoprotein-B (10.9%). Saroglitazar treatment was generally safe and well tolerated. No serious adverse events were reported in saroglitazar treatment arm and no persistent change in laboratory parameters. Saroglitazar appeared to be an effective and safe therapeutic option for improving hypertriglyceridemia in patients with type 2 diabetes

  12. Efficacy and Safety of a Lidocaine Gel in Patients from 6 Months up to 8 Years with Acute Painful Sites in the Oral Cavity: A Randomized, Placebo-Controlled, Double-Blind, Comparative Study

    Directory of Open Access Journals (Sweden)

    Dörte Wolf

    2015-01-01

    Full Text Available Lidocaine is a well-accepted topical anaesthetic, also used in minors to treat painful conditions on mucosal membranes. This randomized, double-blind, placebo-controlled study (registered prospectively as EudraCT number 2011-005336-25 was designed to generate efficacy and safety data for a lidocaine gel (2% in younger children with painful conditions in the oral cavity. One hundred sixty-one children were included in two subgroups: 4–8 years, average age 6.4 years, treated with verum or placebo and 6 months–<4 years, average age 1.8 years, treated only with verum. Pain reduction was measured from the time prior to administration to 10 or 30 minutes after. In addition, adverse events and local tolerability were evaluated. In group I, pain was reduced significantly after treatment with verum compared to placebo at both time points. In group II, the individual pain rating shift showed statistically significant lower pain after treatment. Only seven out of 161 patients reported an adverse event but none were classified as being related to the study medication. The local tolerability was assessed as very good in over 97% of cases. For painful sites in the oral cavity, a 2% lidocaine gel is a meaningful tool for short-term treatment in the paediatric population.

  13. Coblation tonsillectomy: a double blind randomized controlled study.

    Science.gov (United States)

    Timms, M S; Temple, R H

    2002-06-01

    Tonsillectomy has been performed by a number of techniques. This double blind randomized controlled study compares the technique of tissue coblation with bipolar dissection for the removal of tonsils in 10 adult patients with a history of chronic tonsillitis. A significant reduction in post-operative pain and more rapid healing of the tonsillar fossae were found in the side removed by tissue coblation. There were no episodes of primary or secondary haemorrhage on either side. This new technique for tonsil removal warrants further study.

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

    NARCIS (Netherlands)

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

    1999-01-01

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

  15. Comparative efficacy of a recombinant feline interferon omega in refractory cases of calicivirus-positive cats with caudal stomatitis: a randomised, multi-centre, controlled, double-blind study in 39 cats.

    Science.gov (United States)

    Hennet, Philippe R; Camy, Guy A L; McGahie, David M; Albouy, Maxime V

    2011-08-01

    Chronic caudal stomatitis with alveolar/buccal mucositis in calicivirus-positive cats is the most severe presentation of feline chronic gingivostomatitis. Refractory cases are helped by antibiotic and anti-inflammatory treatments often including glucocorticoids. In order to evaluate the comparative efficacy of oromucosal administration of recombinant feline interferon omega (rFeIFN-ω) versus oral administration of glucocorticoids, a randomised, multi-centre, controlled, double-blind study was performed in 39 cats. The progression of behavioural, clinical and lesional scores was assessed over 90 days. Daily oromucosal treatment with 0.1 MU of rFeIFN-ω was associated with a significant improvement of clinical lesions (caudal stomatitis and alveolar/buccal mucositis) and a decrease of pain scores from D0 to D90. Although no such statistical improvement was noticed in the prednisolone group, there was, however, no significant difference between the two groups for most of the parameters, except pain at D60 and D90.

  16. A double-blind, randomized, comparative study of the use of a combination of uridine triphosphate trisodium, cytidine monophosphate disodium, and hydroxocobalamin, versus isolated treatment with hydroxocobalamin, in patients presenting with compressive neuralgias

    Science.gov (United States)

    Goldberg, Henrique; Mibielli, Marco Antonio; Nunes, Carlos Pereira; Goldberg, Stephanie Wrobel; Buchman, Luiz; Mezitis, Spyros GE; Rzetelna, Helio; Oliveira, Lisa; Geller, Mauro; Wajnsztajn, Fernanda

    2017-01-01

    Context This paper reports on the results of treatment of compressive neuralgia using a combination of nucleotides (uridine triphosphate trisodium [UTP] and cytidine monophosphate disodium [CMP]) and vitamin B12. Objectives To assess the safety and efficacy of the combination of nucleotides (UTP and CMP) and vitamin B12 in patients presenting with neuralgia arising from neural compression associated with degenerative orthopedic alterations and trauma, and to compare these effects with isolated administration of vitamin B12. Methods A randomized, double-blind, controlled trial, consisting of a 30-day oral treatment period: Group A (n=200) receiving nucleotides + vitamin B12, and Group B (n=200) receiving vitamin B12 alone. The primary study endpoint was the percentage of subjects presenting pain visual analog scale (VAS) scores ≤20 at end of study treatment period. Secondary study endpoints included the percentage of subjects presenting improvement ≥5 points on the patient functionality questionnaire (PFQ); percentage of subjects presenting pain reduction (reduction in VAS scores at study end in relation to pretreatment); and number of subjects presenting adverse events. Results The results of this study showed a more expressive improvement in efficacy evaluations among subjects treated with the combination of nucleotides + vitamin B12, with a statistically significant superiority of the combination in pain reduction (evidenced by VAS scores). There were adverse events in both treatment groups, but these were transitory and no severe adverse event was recorded during the study period. Safety parameters were maintained throughout the study in both treatment groups. Conclusion The combination of uridine, cytidine, and vitamin B12 was safe and effective in the treatment of neuralgias arising from neural compression associated with degenerative orthopedic alterations and trauma. PMID:28243144

  17. COMPARATIVE EVALUATION OF ORALLY DISINTEGRATING FILM OF ONDANSETRON VERSUS INTRAVENOUS GRANISETRON IN PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING FOLLOWING LAPAROSCOPIC CHOLECYSTECTOMY: A PROSPECTIVE, RANDOMIZED DOUBLE - BLIND PLACEBO - CONTROLLED STUDY

    Directory of Open Access Journals (Sweden)

    Snehalatha

    2015-05-01

    Full Text Available BACKGROUND : Ondansetron and granisetron are first generation 5 - hydroxytry - ptamine - 3 (5 - HT3 receptor antagonists widely used in the prophylaxis of postoperative nausea and vomiting (PONV. Orally Disintegrating Film (ODF formulations are novel and advanced oral drug delivery systems used in management of (PONV. We aimed to study the efficacy of ODF of Ondansetron in the prophylaxis of PONV and to compare it with intravenous Granisetron and placebo in patients undergoing Laparoscopic cholecystectomy . MATERIALS AND METHODS : In this prospective, randomized double - blind placebo - controlled study, 120 consented adult patients of ASA grade I and grade II, aged between 25 - 55 years of both genders, undergoing elective Laparoscopic cholecystectomy , w ere randomized into 3 groups of 40 patients each as Placebo, intravenous Granisetron 2mg and ODF of Ondansetron 8mg (ODF8 g roups. Study drugs were administered just before induction of Anaesthesia. Standardized anesthetic technique was used, and data was collected. Incidence of PONV was assessed and the number of patients suffering from nausea and vomiting at 0 - 6, 7 - 14, and overall 0 - 24 hours post - operatively was evaluated in all the groups and need for rescue anti - emetic noted. RESULTS : Data was analysed using one - way ANOVA test, Chi ‑ square test and Mann – Whitney test. The incidence and severity of nausea and vomiting at different time intervals in Group G and ODF Group was significantly lower when compared with Placebo Group ( p=0.000 . But there was no significant difference in between the ODF and in travenous groups. There was no significant difference in the incidence of side effects in between the three groups. CONCLUSION : orally disintegrating film of Ondansetron is a safe, simple and cost - effective, novel formulation , equally effective to intraven ous Granisetron in preventing PONV in patients undergoing laparoscopic cholecystectomy.

  18. Low frequency (1-Hz), right prefrontal repetitive transcranial magnetic stimulation (rTMS) compared with venlafaxine ER in the treatment of resistant depression: a double-blind, single-centre, randomized study.

    Science.gov (United States)

    Bares, Martin; Kopecek, Miloslav; Novak, Tomas; Stopkova, Pavla; Sos, Peter; Kozeny, Jiri; Brunovsky, Martin; Höschl, Cyril

    2009-11-01

    Previous studies have shown effectiveness of repetitive transcranial magnetic stimulation (rTMS) in the treatment of depression. This double-blind study compared efficacy of l Hz rTMS over the right prefrontal dorsolateral cortex with venlafaxine ER in the treatment of resistant depression. A total of 60 inpatients with depressive disorder (DSM-IV criteria), who previously did not respond to at least one antidepressant treatment, were randomly assigned to 1 Hz rTMS with placebo and venlafaxine ER with sham rTMS for 4 weeks. The primary outcome measure was score change in the Montgomery-Asberg Depression Rating Scale (MADRS). We also used Clinical Global Impression (CGI) and Beck Depressive. Inventory-Short Form (BDI-SF). The response was defined as a >or=50% reduction of MADRS score. There were no significant differences between treatment groups in MADRS (p=0.38), BDI-SF (p=0.56) and CGI (p=0.17) scores from baseline to endpoint. Response rates for rTMS (33%) and venlafaxine (39%) as well as remission (MADRS scorestudy suggest that, at least in the acute treatment, the right sided rTMS produces clinically relevant reduction of depressive symptomatology in patients with resistant depression comparable to venlafaxine ER. Larger sample sizes are required to confirm these results.

  19. 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:

  20. Study oOf Important Psychosocial Factors in Institutionalized Blinds

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    Uddhav T Kumbhar, Armaity Dehmubed

    2011-01-01

    Full Text Available Background: Blindness probably is the most feared infirmity of mankind. The blind individuals were considered useless for the centuries till recent development in culture and civilization. Present study was conducted with the aim to study important psychosocial aspects of blinds undergoing formal vocational training in institutes. Objective: to identify candidates’ psychosocial profile using Self Reporting Questionnaire (S.R.Q.. Materials and Methods: it was a cross sectional study conducted in two vocational training institutes for blinds (one for males and other for females in Mumbai. The individuals were subjected to pre tested S.R.Q. and the individuals found positive with this tool and double the number of matched S.R.Q. negative controls from the institute were subjected to psychiatric examination done by qualified psychiatrist. Analysis: analysis was done using fisher’s exact test and chi square test results: 15 (7.18% blinds were found S.R.Q. positive indicating they either have or prone to have psychiatric morbidity. Conclusion: Psychological rehabilitation of the blinds should be considered before planning the vocational training of blinds.

  1. Prospective multicentre randomised, double-blind, equivalence study comparing clonidine and midazolam as intravenous sedative agents in critically ill children: the SLEEPS (Safety profiLe, Efficacy and Equivalence in Paediatric intensive care Sedation) study.

    Science.gov (United States)

    Wolf, Andrew; McKay, Andrew; Spowart, Catherine; Granville, Heather; Boland, Angela; Petrou, Stavros; Sutherland, Adam; Gamble, Carrol

    2014-12-01

    Children in paediatric intensive care units (PICUs) require analgesia and sedation but both undersedation and oversedation can be harmful. Evaluation of intravenous (i.v.) clonidine as an alternative to i.v. midazolam. Multicentre, double-blind, randomised equivalence trial. Ten UK PICUs. Children (30 days to 15 years inclusive) weighing ≤ 50 kg, expected to require ventilation on PICU for > 12 hours. Clonidine (3 µg/kg loading then 0-3 µg/kg/hour) versus midazolam (200 µg/kg loading then 0-200 µg/kg/hour). Maintenance infusion rates adjusted according to behavioural assessment (COMFORT score). Both groups also received morphine. Primary end point Adequate sedation defined by COMFORT score of 17-26 for ≥ 80% of the time with a ± 0.15 margin of equivalence. Secondary end points Percentage of time spent adequately sedated, increase in sedation/analgesia, recovery after sedation, side effects and safety data. The study planned to recruit 1000 children. In total, 129 children were randomised, of whom 120 (93%) contributed data for the primary outcome. The proportion of children who were adequately sedated for ≥ 80% of the time was 21 of 61 (34.4%) - clonidine, and 18 of 59 (30.5%) - midazolam. The difference in proportions for clonidine-midazolam was 0.04 [95% confidence interval (CI) -0.13 to 0.21], and, with the 95% CI including values outside the range of equivalence (-0.15 to 0.15), equivalence was not demonstrated; however, the study was underpowered. Non-inferiority of clonidine to midazolam was established, with the only values outside the equivalence range favouring clonidine. Times to reach maximum sedation and analgesia were comparable hazard ratios: 0.99 (95% CI 0.53 to 1.82) and 1.18 (95% CI 0.49 to 2.86), respectively. Percentage time spent adequately sedated was similar [medians clonidine 73.8% vs. midazolam 72.8%: difference in medians 0.66 (95% CI -5.25 to 7.24)]. Treatment failure was 12 of 64 (18.8%) on clonidine and

  2. A double-blind, randomized, comparative study of the use of a combination of uridine triphosphate trisodium, cytidine monophosphate disodium, and hydroxocobalamin, versus isolated treatment with hydroxocobalamin, in patients presenting with compressive neuralgias

    Directory of Open Access Journals (Sweden)

    Goldberg H

    2017-02-01

    Full Text Available Henrique Goldberg,1 Marco Antonio Mibielli,2 Carlos Pereira Nunes,2 Stephanie Wrobel Goldberg,3 Luiz Buchman,4 Spyros GE Mezitis,5 Helio Rzetelna,6 Lisa Oliveira,2 Mauro Geller,2 Fernanda Wajnsztajn7 1UERJ Medical School, Rio de Janeiro, Brazil; 2UNIFESO Medical School, Teresópolis, Brazil; 3Washington University School of Medicine, St Louis, MO, USA; 4Instituto de Pós-Graduação Médica Carlos Chagas (ICC, Rio de Janeiro, Brazil; 5New York-Presbyterian Hospital/Weill-Cornell Medical Center, New York, NY, USA; 6Santa Casa da Misericórdia do Rio de Janeiro, Rio de Janeiro, Brazil; 7New York-Presbyterian Hospital/Columbia University Medical Center, Neurology, New York, NY, USA Context: This paper reports on the results of treatment of compressive neuralgia using a combination of nucleotides (uridine triphosphate trisodium [UTP] and cytidine monophosphate disodium [CMP] and vitamin B12.Objectives: To assess the safety and efficacy of the combination of nucleotides (UTP and CMP and vitamin B12 in patients presenting with neuralgia arising from neural compression associated with degenerative orthopedic alterations and trauma, and to compare these effects with isolated administration of vitamin B12. Methods: A randomized, double-blind, controlled trial, consisting of a 30-day oral treatment period: Group A (n=200 receiving nucleotides + vitamin B12, and Group B (n=200 receiving vitamin B12 alone. The primary study endpoint was the percentage of subjects presenting pain visual analog scale (VAS scores ≤20 at end of study treatment period. Secondary study endpoints included the percentage of subjects presenting improvement ≥5 points on the patient functionality questionnaire (PFQ; percentage of subjects presenting pain reduction (reduction in VAS scores at study end in relation to pretreatment; and number of subjects presenting adverse events. Results: The results of this study showed a more expressive improvement in efficacy evaluations among

  3. Randomized, double-blind, placebo-controlled and active-controlled study to assess the relative abuse potential of oxycodone HCl-niacin tablets compared with oxycodone alone in nondependent, recreational opioid users

    Directory of Open Access Journals (Sweden)

    Webster LR

    2012-08-01

    Full Text Available Lynn R Webster,1 Robert L Rolleri,2,3 Glenn C Pixton,3 Kenneth W Sommerville31Lifetree Clinical Research, Salt Lake City, UT, USA; 2Salix Pharmaceuticals, Inc., Raleigh, NC, USA; 3Pfizer Inc, Cary, NC, USABackground: Abuse-deterrent formulations attempt to address public health and societal concerns regarding opioid abuse. Oxycodone HCl-niacin tablets combine oxycodone HCl with niacin and functional inactive excipients to create potential barriers to oral, intranasal, and intravenous abuse. This study compared the relative abuse potential of oral immediate-release oxycodone HCl-niacin with that of oral immediate-release oxycodone HCl and placebo in nondependent, recreational opioid users.Methods: Forty-nine participants received oxycodone HCl-niacin 40/240 mg and 80/480 mg, oxycodone 40 mg and 80 mg, and placebo in a randomized, double-blind, placebo-controlled and active-controlled, five-way crossover study. Primary endpoints based on a bipolar 100 mm visual analog scale for drug liking were area under effect curve (AUE0–1h, AUE0–2h, AUE0–3h, peak disliking, and effect at 0.5 hours post-dose (E0.5h. Other endpoints included take drug again assessment, overall drug liking, and pupillometry.Results: There were statistically significant differences between oxycodone HCl-niacin and oxycodone HCl doses for all primary endpoints (P < 0.0001, all comparisons, suggesting reduced abuse potential with oxycodone HCl-niacin. Take drug again and overall drug liking showed greater liking of oxycodone alone. Oxycodone HCl-niacin 80/480 mg had consistently lower liking assessments than oxycodone HCl-niacin 40/240 mg, suggesting a dose-response to the aversive effects of niacin. Opioid-related adverse events were similar for equivalent oxycodone doses. The treatment-emergent adverse events most specifically associated with oxycodone HCl-niacin (ie, skin-burning sensation, warmth, and flushing were consistent with the expected vasocutaneous effects of

  4. 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

  5. Double-blind, randomized, multicentre, and active comparator controlled investigation of the effect of Pioglitazone, Metformin, and the combination of both on cardiovascular risk in patients with type 2 diabetes receiving stable basal insulin therapy: the PIOCOMB study

    Directory of Open Access Journals (Sweden)

    Kleine Iris

    2011-07-01

    Full Text Available Abstract Background We analyzed specific effects of an add-on therapy with pioglitazone compared to metformin and their combination in patients with basal insulin treatment on biomarkers of CV risk. Methods In this double-blind, randomized, multicentre, active comparator controlled trial, 121 patients with type 2 diabetes were enrolled. Inclusions: treatment with basal insulin, HbA1C 6.5% - 8.5%, age 30 - 75 years. After glargine therapy over 2 weeks for titration towards FBG ≤ 7.8 mmol/L, patients received either (A bid 850 mg metformin (n = 42, (B bid 15 mg pioglitazone (n = 40, or (C 30 mg pioglitazone plus 1.7 g metformin (n = 39 over 6 months. Matrix Metal Proteinase 9 (MMP-9 was primary objective, together with biomarkers of CV risk. Results Pioglitazone (B reduced MMP-9 versus baseline by 54.1 + 187.1 ng/mL, with metformin (A it was increased by 49.6 + 336.2 ng/mL (p = 0.0345; B vs. A, and with the combination of both (C it was decreased by 67.8 + 231.4 ng/mL (A vs. C: p = 0.0416; B vs. C: p = 0.8695. After logarithmic transformation due to high variances the exploratory results showed significance for A vs. B (p = 0.0043 and for A vs. C (p = 0.0289. Insulin dosage was reduced by 7.3 units in group B (p 1C was only significantly decreased in the combination group. No significant effects were observed for NFkB and PGFα. peripheral edema were seen in 11.9% vs. 40.0% vs. 20.5%, and weight change was -0.7 kg vs. +4.3 kg vs. +2.7 kg (A vs. B vs. C. Conclusions Addition of pioglitazone but not of metformin reduces MMP-9, hs-CRP and increased insulin sensitivity and adiponectin in this study. The combination of both had no additional effect on inflammation. Pioglitazone is suggested to be a rational add-on therapy to basal insulin in patients with high CV risk.

  6. Do open label blinded outcome studies of novel anticoagulants versus warfarin have equivalent validity to those carried out under double-blind conditions?

    Science.gov (United States)

    O'Neil, William M; Welner, Sharon A; Lip, Gregory Y H

    2013-03-01

    Recent anticoagulants for stroke prevention in AF have been tested in active comparator controlled studies versus warfarin using two designs: double-blind, double-dummy and prospective randomised, open blinded endpoint (PROBE). The former requires elaborate procedures to maintain blinding, while PROBE does not. Outcomes of double-blind and PROBE designed studies of novel anticoagulants for AF, focusing on warfarin controls, were explored. Major, Phase III warfarin-controlled trials for stroke prevention in AF were identified. Odds ratios (ORs) of key outcomes for active comparators versus VKA and event rates for VKA arms were compared between designs, in context of baseline demographics and inclusion criteria. Identified trials studied five novel anticoagulants in three each of PROBE and double-blind design. For ORs of results across studies and outcomes, there was little pattern differentiating the two designs. Among VKA-control subjects, event rates for the primary outcome (stroke or systemic embolism) in PROBE trials at 1.74 %/year (95% confidence interval: 1.54-1.95) was not significantly different from that in double-blind trials, at 1.88 (1.73-2.03). Among other outcomes, VKA-treated subjects in both trial designs had similar event rates, apart from higher all-cause mortality in ROCKET AF, and lower myocardial infarction rates among the PROBE study patients. Although there are differences in outcome between PROBE and double blind trials, they do not appear to be design-related. The exacting requirements of double-blinding in AF trials may not be necessary.

  7. A Randomized Double-Blind Crossover Study of Phase-Shift Sound Therapy for Tinnitus

    NARCIS (Netherlands)

    Heijneman, Karin M.; de Kleine, Emile; van Dijk, Pim

    2012-01-01

    Objective. The purpose of this study was to compare the efficacy of the treatment of tinnitus with a phase-shifting pure tone to that of the same tone treatment without phase shifting. Study Design. A double-blind crossover randomized controlled trial. Setting. This study was conducted at the Univer

  8. A randomized controlled double-blinded prospective study of the efficacy of clonidine added to bupivacaine as compared with bupivacaine alone used in supraclavicular brachial plexus block for upper limb surgeries

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    Shivinder Singh

    2010-01-01

    Full Text Available We compared the effects of clonidine added to bupivacaine with bupivacaine alone on supraclavicular brachial plexus block and observed the side-effects of both the groups. In this prospective, randomized,double-blinded, controlled trial, two groups of 25 patients each were investigated using (i 40 ml of bupivacaine 0.25% plus 0.150 mg of clonidine and (ii 40 ml of bupivacaine 0.25% plus 1 ml of NaCl 0.9, respectively. The onset of motor and sensory block and duration of sensory block were recorded along with monitoring of heart rate, non-invasive blood pressure, oxygen saturation and sedation. It was observed that addition of clonidine to bupivacaine resulted in faster onset of sensory block, longer duration of analgesia (as assessed by visual analogue score, prolongation of the motor block (as assessed by modified Lovett Rating Scale, prolongation of the duration of recovery of sensation and no association with any haemodynamic changes (heart rate and blood pressure, sedation or any other adverse effects. These findings suggest that clonidine added to bupivacaine is an attractive option for improving the quality and duration of supraclavicular brachial plexus block in upper limb surgeries.

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

    Science.gov (United States)

    Missouri Department of Elementary and Secondary Education, 2012

    2012-01-01

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

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

    Science.gov (United States)

    Missouri Department of Elementary and Secondary Education, 2011

    2011-01-01

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

  11. Antitussive effect of a fixed combination of Justicia adhatoda, Echinacea purpurea and Eleutherococcus senticosus extracts in patients with acute upper respiratory tract infection: A comparative, randomized, double-blind, placebo-controlled study.

    Science.gov (United States)

    Barth, Anders; Hovhannisyan, Areg; Jamalyan, Kristina; Narimanyan, Mikael

    2015-12-01

    Kan Jang® oral solution (KJ) is a fixed combination of aqueous ethanolic extracts of Justicia adhatoda L. leaf, Echinacea purpurea (L.) Moench root, and Eleutherococcus senticosus (Rupr. & Maxim.) Harms root. It is approved in Scandinavia as an herbal medicinal product for respiratory tract infection treatment. The present clinical trial aimed to compare the antitussive effect of KJ with placebo (PL) and bromhexine (BH) among patients of 18-65 years old with non-complicated upper respiratory infections (URI; i.e., common cold). We performed a parallel-group, randomized, double-blinded, placebo-controlled trial in in 177 patients with acute URI over a 5 day period. We investigated the antitussive effects of a KJ (30 ml/day; 762 mg genuine extracts with standardized contents of 0.2 mg/ml vasicine, 0.8 mg/ml chicoric acid, and 0.03 mg/ml eleutherosides B and E), bromhexine hydrochloride (24 mg/30 ml/day) and PL on cough and blood markers. The primary outcome was cough relief, which was assessed as the change of cough frequency from baseline (cough index). Secondary outcomes were safety with regards to reported adverse events (AEs) and hematological data. Both KJ and BH relieved cough more effectively than placebo. On the third and fourth days of treatment, we observed faster improvement in the group receiving KJ compared to in the groups receiving BH (100%) or PL (100%), indicating a slightly shorter recovery time in the KJ group. KJ showed a good tolerability and safety profile. KJ exerted significant antitussive effects in URI. The present data further support the therapeutic use of KJ in upper respiratory tract infections. Copyright © 2015 The Authors. Published by Elsevier GmbH.. All rights reserved.

  12. [Trimetazidine versus betahistine in vestibular vertigo. A double blind study].

    Science.gov (United States)

    Kluyskens, P; Lambert, P; D'Hooge, D

    1990-01-01

    The efficacy of trimetazidine (60 mg/day) in vertigo was compared with that of betahistine (24 mg/day) in a three-month double-blind study. Included in the study were only patients with peripheral vertigo associated or not with tinnitus or hearing loss, and excluded were those presenting with symptoms related to retrocochlear or central disease. Out of the 40 patients enrolled, 20 suffered from Meniere's disease; 4 patients either dropped out of the study or were non-compliant to therapy and could not be taken into account in the final analysis, which bore on 36 patients (18 treated by trimetazidine and 18 with betahistine). There were no dropouts in the Meniere's disease subgroup (10 receiving trimetazidine and 10 receiving betahistine). Results revealed a better response to therapy with trimetazidine in patients suffering from vertigo, and this was particularly true of the Meniere's disease subgroup (p less than 0.025). Moreover, in the latter subgroup, all patients treated with trimetazidine fully recovered from vertigo spells, while these disappeared completely only in 4 of the patients administered betahistine (p less than 0.005). There was no noticeable difference between the two treatment groups as regards the evolution of the accompanying symptoms and the audiometric or vestibular test results. Clinical acceptability was equally excellent in both treatment groups. Overall, this study allowed to confirm the therapeutical efficacy of trimetazidine in the management of vertigo, as well as establishing the clinical advantage of trimetazidine over betahistine in patients suffering from Meniere's disease.

  13. Postcoital Sperm Assessment Comparative Study.

    Science.gov (United States)

    Pelekanos, Michael J

    2015-11-01

    This postcoital sperm assessment study was performed over a 10 month time period (November 2014-August 2015). Fifteen couples enrolled in the study. The study was a non-blinded, non-randomized, single-center comparison study comparing The Stork® OTC (Rinovum Women's Health, Monroeville, PA) to natural intercourse (NI), using the subjects as their own control/baseline. This was an efficacy study designed to compare the number of sperm in the cervical mucus following the use of The Stork OTC conception aid with the number of sperm in the cervical mucus following natural intercourse. Subjects used both The Stork OTC conception system and the natural intercourse method to evaluate concentrations of sperm in the cervical mucus. Post-coital test (PCT) data was collected demonstrating higher concentrations of sperm within the cervical mucus with The Stork OTC conception system versus natural intercourse for 85% of test subjects in this study. Of the 15 couples enrolled in the study, 2 were lost to follow-up. Mean age for male subjects was 31.7 +/ 5.4 years of age and mean age for female subjects was 29.7+/- 5.4. The average sperm score value of the 85% of test subjects with higher sperm concentrations from The Stork OTC was 3.23 times the score value of sperm concentration compared to natural intercourse. The remaining 15% of test subjects showed no change in sperm score value between The Stork OTC and natural intercourse.

  14. Adaptive changes in early and late blind: a FMRI study of verb generation to heard nouns.

    Science.gov (United States)

    Burton, H; Snyder, A Z; Diamond, J B; Raichle, M E

    2002-12-01

    Literacy for blind people requires learning Braille. Along with others, we have shown that reading Braille activates visual cortex. This includes striate cortex (V1), i.e., banks of calcarine sulcus, and several higher visual areas in lingual, fusiform, cuneus, lateral occipital, inferior temporal, and middle temporal gyri. The spatial extent and magnitude of magnetic resonance (MR) signals in visual cortex is greatest for those who became blind early in life. Individuals who lost sight as adults, and subsequently learned Braille, still exhibited activity in some of the same visual cortex regions, especially V1. These findings suggest these visual cortex regions become adapted to processing tactile information and that this cross-modal neural change might support Braille literacy. Here we tested the alternative hypothesis that these regions directly respond to linguistic aspects of a task. Accordingly, language task performance by blind persons should activate the same visual cortex regions regardless of input modality. Specifically, visual cortex activity in blind people ought to arise during a language task involving heard words. Eight early blind, six late blind, and eight sighted subjects were studied using functional magnetic resonance imaging (fMRI) during covert generation of verbs to heard nouns. The control task was passive listening to indecipherable sounds (reverse words) matched to the nouns in sound intensity, duration, and spectral content. Functional responses were analyzed at the level of individual subjects using methods based on the general linear model and at the group level, using voxel based ANOVA and t-test analyses. Blind and sighted subjects showed comparable activation of language areas in left inferior frontal, dorsolateral prefrontal, and left posterior superior temporal gyri. The main distinction was bilateral, left dominant activation of the same visual cortex regions previously noted with Braille reading in all blind subjects. The

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1982-11-01

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

  16. Comparison of physiotherapy, manipulation, and corticosteroid injection for treating shoulder complaints in general practice : Randomised, single blind study

    NARCIS (Netherlands)

    Winters, Jan C.; Sobel, J.S.; Groenier, Klaas H.; Arendzen, J.H.; Meyboom-de Jong, B.

    1997-01-01

    Objective: To compare the efficacy of physiotherapy, manipulation, and corticosteroid injection for treating patients with shoulder complaints in general practice. Design: Randomised, single blind study. Setting: Seven general practices in the Netherlands. Subjects: 198 patients with shoulder compla

  17. Comparison of physiotherapy, manipulation, and corticosteroid injection for treating shoulder complaints in general practice : Randomised, single blind study

    NARCIS (Netherlands)

    Winters, Jan C.; Sobel, J.S.; Groenier, Klaas H.; Arendzen, J.H.; Meyboom-de Jong, B.

    1997-01-01

    Objective: To compare the efficacy of physiotherapy, manipulation, and corticosteroid injection for treating patients with shoulder complaints in general practice. Design: Randomised, single blind study. Setting: Seven general practices in the Netherlands. Subjects: 198 patients with shoulder

  18. Double-blind randomized controlled study of coblation tonsillotomy versus coblation tonsillectomy on postoperative pain.

    Science.gov (United States)

    Arya, A; Donne, A J; Nigam, A

    2003-12-01

    This double-blind randomized controlled trial of coblation tonsillotomy versus coblation tonsillectomy uses visual analogue scoring to compare the pain experienced in the 24h postoperative period. No statistically significant difference in pain is demonstrated in the group of 14 patients studied. Tonsillectomy is recommended over tonsillotomy.

  19. Early cessation of triptorelin in in vitro fertilization : a double-blind, randomized study

    NARCIS (Netherlands)

    Simons, AHM; Roelofs, HJM; Schmoutziguer, APE; Roozenburg, BJ; van't Hof-van den Brink, EP; Schoonderwoerd, SA

    2005-01-01

    Objective: To compare the efficacy of two early cessation protocols of triptorelin treatment in controlled ovarian hyperstimulation with the conventional long protocol in in vitro ferfilization/intracytoplasmic sperm injection. Design: A double-blind, randomized, multicenter study. Setting: Three Du

  20. Pitavastatin and Atorvastatin double-blind randomized comPArative study among hiGh-risk patients, including thOse with Type 2 diabetes mellitus, in Taiwan (PAPAGO-T Study.

    Directory of Open Access Journals (Sweden)

    Ping-Yen Liu

    Full Text Available BACKGROUND: Evidence about the efficacy and safety of statin treatment in high-risk patients with hypercholesterolemia is available for some populations, but not for ethnic Chinese. To test the hypothesis that treatment with pitavastatin (2 mg/day is not inferior to treatment with atorvastatin (10 mg/day for reducing low-density lipoprotein cholesterol (LDL-C, a 12-week multicenter collaborative randomized parallel-group comparative study of high-risk ethnic Chinese patients with hypercholesterolemia was conducted in Taiwan. In addition, the effects on other lipid parameters, inflammatory markers, insulin-resistance-associated biomarkers and safety were evaluated. METHODS AND RESULTS: Between July 2011 and April 2012, 251 patients were screened, 225 (mean age: 58.7 ± 8.6; women 38.2% [86/225] were randomized and treated with pitavastatin (n = 112 or atorvastatin (n = 113 for 12 weeks. Baseline characteristics in both groups were similar, but after 12 weeks of treatment, LDL-C levels were significantly lower: pitavastatin group = -35.0 ± 14.1% and atorvastatin group = -38.4 ± 12.8% (both: p < 0.001. For the subgroup with diabetes mellitus (DM (n = 125, LDL-C levels (-37.1 ± 12.9% vs. -38.0 ± 13.1%, p = 0.62 were similarly lowered after either pitavastatin (n = 63 or atorvastatin (n = 62 treatment. Triglycerides, non-high density lipoprotein cholesterol, and apoprotein B were similarly and significantly lower in both treatment groups. In non-lipid profiles, HOMA-IR and insulin levels were higher to a similar degree in both statin groups. Hemoglobin A1C was significantly (p = 0.001 higher in the atorvastatin group but not in the pitavastatin group. Both statins were well tolerated, and both groups had a similar low incidence of treatment-emergent adverse events. CONCLUSION: Both pitavastatin (2 mg/day and atorvastatin (10 mg/day were well tolerated, lowered LDL-C, and improved the lipid profile to a comparable degree in high-risk Taiwanese

  1. 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.

  2. 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 (p<0.0001) in the triple therapy group (healing: 98.6%; Helicobacter pylori cure 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%; p<0.0022). After one year, Helicobacter pylori eradication was re-confirmed in 46/58 patients previously treated with the triple therapy and in 10/40 patients treated with the dual therapy [p<0.0001]. Only three duodenal ulcer 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.

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

    Directory of Open Access Journals (Sweden)

    Amini Reza

    2010-08-01

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

  4. Dietary treatment of infant colic: a double-blind study.

    OpenAIRE

    Campbell, J. P.

    1989-01-01

    The possible role of cows milk intolerance in the aetiology of infant colic was evaluated in 19 babies presenting to their health visitor or general practitioner in one town. Over a three week period a standard modified cows milk formula was compared with a soya milk formula on a double blind basis. The duration of colic symptoms was significantly reduced during the week on soya milk (P less than 0.01), with 11 out of 19 babies fulfilling the diagnostic criteria for cows milk intolerance. Fou...

  5. A comparative study of propofol and N2O versus sevoflurane and N2O with respect to haemodynamic response and ease of laryngeal mask airway insertion: a prospective randomized double blinded study

    Directory of Open Access Journals (Sweden)

    Veena Mathur

    2016-08-01

    Results: time for induction and LMA insertion was significantly faster in propofol group than group S (p<0.05. Successful LMA insertion in first attempt was 100% in group P with excellent conditions (score 18 while in group S, it was 86.7% with excellent to satisfactory conditions (score 16-17. A significant fall in mean arterial pressure (p<0.05 was noted in group P while pulse rates were comparable in both groups. Conclusions: Sevoflurane vital capacity breath inhalational induction can be used as an effective alternative to propofol though it requires greater time for LMA insertion but with better haemodynamic stability. [Int J Res Med Sci 2016; 4(8.000: 3421-3426

  6. Comparative Packaging Study

    Science.gov (United States)

    Perchonok, Michele; Antonini, David

    2008-01-01

    This viewgraph presentation describes a comparative packaging study for use on long duration space missions. The topics include: 1) Purpose; 2) Deliverables; 3) Food Sample Selection; 4) Experimental Design Matrix; 5) Permeation Rate Comparison; and 6) Packaging Material Information.

  7. A randomized, blinded study to evaluate the efficacy and safety of umeclidinium 62.5 µg compared with tiotropium 18 µg in patients with COPD

    Directory of Open Access Journals (Sweden)

    Feldman G

    2016-04-01

    Full Text Available Gregory Feldman,1 François Maltais,2 Sanjeev Khindri,3 Mitra Vahdati-Bolouri,3 Alison Church,4 William A Fahy,3 Roopa Trivedi4,5 1S. Carolina Pharmaceutical Research, Spartanburg, SC, USA; 2Institut universitaire de cardiologie et de pneumologie de Québec, Quebec, QC, Canada; 3GSK, Respiratory Research and Development, Middlesex, UK; 4GSK, Respiratory and Immuno-Inflammation Research, Triangle Park, NC, USA; 5Pearl Therapeutics Inc., Durham, NC, USA Background: The long-acting muscarinic antagonists umeclidinium (UMEC and tiotropium (TIO are approved once-daily maintenance therapies for COPD. This study investigated the efficacy and safety of UMEC versus TIO in COPD. Methods: This was a 12-week, multicenter, randomized, blinded, double-dummy, parallel-group, non-inferiority study. Patients were randomized 1:1 to UMEC 62.5 µg plus placebo or TIO 18 µg plus placebo. The primary end point was trough forced expiratory volume in 1 second (FEV1 at day 85 (non-inferiority margin -50 mL; per-protocol [PP] population. Other end points included weighted mean FEV1 over 0–24 and 12–24 hours post-dose. Patient-reported outcomes comprised Transition Dyspnea Index score, St George’s Respiratory Questionnaire total score, and COPD Assessment Test score. Adverse events were also assessed. Results: In total, 1,017 patients were randomized to treatment. In the PP population, 489 and 487 patients received UMEC and TIO, respectively. In the PP population, change from baseline in trough FEV1 was greater with UMEC versus TIO at day 85, meeting non-inferiority and superiority margins (difference: 59 mL; 95% confidence interval [CI]: 29–88; P<0.001. Similar results were observed in the intent-to-treat analysis of trough FEV1 at day 85 (53 mL, 95% CI: 25–81; P<0.001. Improvements in weighted mean FEV1 over 0–24 hours post-dose at day 84 were similar with UMEC and TIO but significantly greater with UMEC versus TIO over 12–24 hours post-dose (70

  8. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of saphenofemoral junction incompetence.

    Science.gov (United States)

    Todd, Kenneth L; Wright, D I

    2014-10-01

    VANISH-2 Investigator Group: K Gibson, Bellevue, WA, USA; M Goldman, San Diego, CA, USA; P Hertzman, Los Alamos, NM, USA; S Hirsch, Pittsburgh, PA, USA; R Hye, San Diego, CA, USA; M Isaacs, Walnut Creek, CA, USA; M Plaza-Ponte, Monroeville, PA, USA; S Rathbun, Oklahoma City, OK, USA; J Rhodes, Rochester, NY, USA; G Rosenberg, Frederick, MD, USA; M Schul, Lafayette, IN, USA; M Stanbro, Greenville, SC, USA; and R Weiss, Hunt Valley, MD, USA To determine efficacy and safety of polidocanol endovenous microfoam in treatment of symptoms and appearance in patients with saphenofemoral junction incompetence due to reflux of the great saphenous vein or major accessory veins. Patients were randomized equally to receive polidocanol endovenous microfoam 0.5%, polidocanol endovenous microfoam 1.0% or placebo. The primary efficacy endpoint was patient-reported improvement in symptoms, as measured by the change from baseline to Week 8 in the 7-day average electronic daily diary VVSymQ™ score. The co-secondary endpoints were the improvement in appearance of visible varicosities from baseline to Week 8, as measured by patients and by an independent physician review panel. In 232 treated patients, polidocanol endovenous microfoam 0.5% and polidocanol endovenous microfoam 1.0% were superior to placebo, with a larger improvement in symptoms (VVSymQ (-6.01 and-5.06, respectively, versus -2.00; P < 0.0001) and greater improvements in physician and patient assessments of appearance (P < 0.0001). These findings were supported by the results of duplex ultrasound and other clinical measures. Of the 230 polidocanol endovenous microfoam-treated patients (including open-label patients), 60% had an adverse event compared with 39% of placebo; 95% were mild or moderate. No pulmonary emboli were detected and no clinically important neurologic or visual adverse events were reported. The most common adverse events in patients treated with polidocanol endovenous microfoam were retained

  9. [The study of establishment of the " Chinese provincial Blindness prevention technical guidance group performance evaluation system"].

    Science.gov (United States)

    Lu, L N; He, X G; Zhu, J F; Xu, X; Zhang, R; Hu, X; Zou, H D

    2016-11-11

    Objective: To establish an assessment system, including indexes and scoring methods, that can be used for performance evaluation of the provincial blindness prevention technical guidance group properly and effectively . Methods: The indexes and scoring methods were set based on the core content of The " National Plan of Prevention and Treatment of Blindness (2012-2015)" , the specific requirement and target of the World Health Organization (WHO) "For the General Eye Health: Global plan of Action (2014-2019)" , and the current situation of the China's provinces and autonomous regions. These indexes should be of effectiveness, feasibility, comparability, guidance and advancing. Formed by a literature review of candidate indicators, the framework of the system is built by qualitative assessment. With the Delphi method, the system was further revised and improved. Empirical pilot study was then used to prove the feasibility, followed by the final qualitative analysis that establish the " Chinese provincial Blindness prevention technical guidance group performance evaluation system" . Results: Through the literature review and qualitative assessment, a six dimensional system framework was built, including 6 first-level indicators, 16 second-level indicators, and 29 third-level indicators through Delphi method evaluation. With the variation coefficient method, the coeffiences of the first-level index weight were calculated as: Organization and management 0.15, Development and implementation of blindness prevention plans 0.15, Implementation of blindness prevention projects 0.14, Training 0.17, Health education 0.18, and Cooperation and exchanges 0.21. The specific scoring method for this system is confirmed as: data and files check, field interview, and record interview, sampling investigation. Empirical pilot study was conducted in the Jilin, Guizhou and Gansu provinces, and the self-assessment results from local experts were consistent with the scores from the systems

  10. 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

  11. How Visual Is the Visual Cortex? Comparing Connectional and Functional Fingerprints between Congenitally Blind and Sighted Individuals.

    Science.gov (United States)

    Wang, Xiaoying; Peelen, Marius V; Han, Zaizhu; He, Chenxi; Caramazza, Alfonso; Bi, Yanchao

    2015-09-09

    Classical animal visual deprivation studies and human neuroimaging studies have shown that visual experience plays a critical role in shaping the functionality and connectivity of the visual cortex. Interestingly, recent studies have additionally reported circumscribed regions in the visual cortex in which functional selectivity was remarkably similar in individuals with and without visual experience. Here, by directly comparing resting-state and task-based fMRI data in congenitally blind and sighted human subjects, we obtained large-scale continuous maps of the degree to which connectional and functional "fingerprints" of ventral visual cortex depend on visual experience. We found a close agreement between connectional and functional maps, pointing to a strong interdependence of connectivity and function. Visual experience (or the absence thereof) had a pronounced effect on the resting-state connectivity and functional response profile of occipital cortex and the posterior lateral fusiform gyrus. By contrast, connectional and functional fingerprints in the anterior medial and posterior lateral parts of the ventral visual cortex were statistically indistinguishable between blind and sighted individuals. These results provide a large-scale mapping of the influence of visual experience on the development of both functional and connectivity properties of visual cortex, which serves as a basis for the formulation of new hypotheses regarding the functionality and plasticity of specific subregions. Significance statement: How is the functionality and connectivity of the visual cortex shaped by visual experience? By directly comparing resting-state and task-based fMRI data in congenitally blind and sighted subjects, we obtained large-scale continuous maps of the degree to which connectional and functional "fingerprints" of ventral visual cortex depend on visual experience. In addition to revealing regions that are strongly dependent on visual experience (early visual

  12. Intracutaneous or subcutaneous sterile water injection compared with blinded controls for pain management in labour.

    Science.gov (United States)

    Derry, Sheena; Straube, Sebastian; Moore, R Andrew; Hancock, Heather; Collins, Sally L

    2012-01-18

    Intracutaneous or subcutaneous injection of sterile water is rapidly gaining popularity as a method of pain relief in labour and it is therefore essential that it is properly evaluated. Adequate analgesia in labour is important to women worldwide. Sterile water injection is inexpensive, requires basic equipment, and appears to have few side effects. It is purported to work for labour pain. To determine the efficacy of sterile water injections for relief of pain (both typical contraction pain and intractable back pain) during labour compared to placebo (isotonic saline injections) or non-pharmacological interventions, and to identify any relevant effects on mode and timing of delivery, or safety of both mother and baby. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 May 2011), MEDLINE, and EMBASE (January 2010 to 30 May 2011), together with reference lists in retrieved studies and review articles. We included randomised, double blind, controlled studies using intracutaneous or subcutaneous sterile water injections for pain relief during labour. There were no restrictions on birth place, parity, risk, age, weight, gestation, or stage of labour. Potential comparators were placebo (saline) and non-pharmacological interventions (e.g. hypnosis or biofeedback). Two review authors independently assessed eligibility and quality of trials, and extracted data. We resolved any disagreements or uncertainties by discussion with a third review author. Primary outcome measures were at least 50% pain relief, or at least 30%, pain relief, patient global impression of change of at least 'good', mode of delivery, perinatal morbidity and mortality, maternal complications and adverse events. Secondary outcomes were women with any pain relief, use of rescue analgesia, and treatment group average pain relief. We made explicit judgements about potential biases in the studies. We included seven studies, with 766 participants: four used intracutaneous

  13. Randomized, Double-Blinded, Double-Dummy, Active-Controlled, and Multiple-Dose Clinical Study Comparing the Efficacy and Safety of Mulberry Twig (Ramulus Mori, Sangzhi Alkaloid Tablet and Acarbose in Individuals with Type 2 Diabetes Mellitus

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    Mengyi Li

    2016-01-01

    Full Text Available Aims. To evaluate the efficacy and safety of mulberry twig alkaloid (SZ-A tablet compared with acarbose in patients with type 2 diabetes. Methods. This clinical trial enrolled 38 patients who were randomized into two groups (SZ-A: 23; acarbose: 15 and were treated for 24 weeks. Patients and clinical trial staffs were masked to treatment assignment throughout the study. The primary outcome measures were glycated hemoglobin (HbA1c and 1-hour and 2-hour postprandial and fasting plasma glucose levels from baseline to the end of treatment. Analysis included all patients who completed this study. Results. By the end of this study, HbA1c level in SZ-A group was decreased from baseline significantly (P<0.001. No significant difference was found when compared with acarbose group (P=0.652. Similarly, 1-hour and 2-hour postprandial plasma glucose levels in SZ-A group were decreased from baseline statistically (P<0.05, without any significant differences compared with acarbose group (P=0.748 and 0.558, resp.. The fasting plasma glucose levels were not significantly changed in both groups. One of 23 patients in SZ-A group (4.76% and 5 of 15 patients in acarbose group (33.33% suffered from gastrointestinal adverse events. Conclusions. Compared with acarbose, SZ-A tablet was effective and safe in glycemic control in patients with type 2 diabetes.

  14. Body Experiences of Persons Who Are Congenitally Blind: A Phenomenological-Psychological Study.

    Science.gov (United States)

    Bullington, J.; Karlsson, G.

    1997-01-01

    A study of seven people with congenital blindness, three with adventitious blindness, and four sighted people investigated how people with congenital blindness experience body capability, body expression, and the social and psychological, identity creating aspects of the body and body experience. The value of exercise and body-awareness training…

  15. Voxel-Based Morphometric Study on Chinese Blind Men's Brain Structure

    Institute of Scientific and Technical Information of China (English)

    YANG Chun-lan; PAN Wen-ju; ZHENG Lian

    2007-01-01

    Many studies have shown the functional relevance of cross-modal plasticity in blind men.In order to study the changes of their brain structure,voxel-based morphometry (VBM) methods are used.The regional gray matter (GM) and white matter (WM) concentrations of magnetic resonance (MR) images from 11 blind people and 9 sighted control subjects are compared using standard VBM.Optimized VBM is also discussed to measure the absolute local volume of GM or WM.Consistent results are achieved by statistical analysis with these methods.There are distinct differences not only in visual cortex but also the sensory area,auditory area and motor area.GM concentrations in blind men significantly decreased in Brodmann 7 and 22.While in Brodmann 18 and 19,GM concentration increased.GM volumes decreased in Brodmann 3,4,6,9 and 45.On the other hand,both WM concentration and volume increased in Brodmann 7.These results suggest that early visual deprivation can lead to changes in the brain structural anatomy which is consistent with the cortical cross-modal reorganization found by functional imaging.It may help to discover the relationship between the brain structural anatomy and the brain functional data of blind men at a macroscopic level from neuroimaging perspective.

  16. 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.

  17. Randomized, Double-Blind Study Comparing Patient Comfort and Safety Between Iodixanol 320 mg I/mL and Iopamidol 370 mg I/mL in Patients Undergoing Peripheral Arteriography - The COMFORT II Trial.

    Science.gov (United States)

    Rosenberg, Christian; Martínez-Rodrigo, José Joaquín; Lonjedo Vicent, Elena; Macho, Juan; Lim, Lauren; Todoran, Thomas M

    2017-01-01

    Numerous clinical trials conducted 10-20 years ago evaluated contrast-induced discomfort. It is unknown whether those data are applicable to current-day clinical practice. This study was performed to provide contemporary contrast-induced patient discomfort data obtained during peripheral arteriography procedures using iso-osmolar iodixanol 320 mg I/mL, compared to low-osmolar iopamidol 370 mg I/mL. Patients receiving iodixanol or iopamidol reported discomfort (heat, coldness, or pain) using a 10-point scale, which was converted to intensity categories: 0 = none; 1-3 = mild; 4-7 = moderate; and 8-10 = severe. Image diagnostic quality was assessed. Patients receiving iodixanol (n = 127; 61% male; mean age, 64 years) had less moderate/severe discomfort (67.7% vs 84.0%; P=.01) than those receiving iopamidol (n = 126; 64% male; mean age, 62 years), with pain contributing predominantly (7.3% vs 44.0%; P<.001) for all injection scores. Patients receiving iodixanol experienced less severe discomfort (16.9% vs 46.4%; P<.001), heat (15.3% vs 36.8%; P<.001), and pain (2.4% vs 23.2%; P<.001) for all injections, compared with patients receiving iopamidol. Image quality was rated as excellent in most patients (iodixanol 86.5% vs iopamidol 82.4%; P=.57). Treatment-emergent adverse events were similar between groups (iodixanol 18.9% vs iopamidol 11.9%; P=.16). Iodixanol injections induced significantly less moderate/severe and severe patient discomfort, heat, or pain than iopamidol, with pain contributing the most. Discomfort did not affect image quality.

  18. PROSPECTIVE, RANDOMIZED, DOUBLE BLIND STUDY TO COMPARE THE EFFICACY AND SAFETY OF GRANISETRON VERSUS ONDANSETRON IN PREVENTION OF POST OPERATIVE NAUSEA AND VOMITING IN PATIENTS UNDERGOING ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY UNDER GENERAL ANAESTHESIA

    Directory of Open Access Journals (Sweden)

    Vijayalakshmi

    2015-09-01

    Full Text Available OBJECTIVE : To compare the efficacy and safety of Granisetron versus Ondansetron in prevention of post - operative nausea and vomiting in patients undergoing elective Laparoscopic Cholecystectomy under general anaesthesia. MATERIALS AND METHODS: After the approval from IEC, the study was started and conducted over a period of two years i.e., from 2010 - 2012. Data was c ollected from 100 ASA I and II patients scheduled for laparoscopic cholecystectomy aged between 20 - 60 years at Government General Hospital, Kakinada. Both the study groups were selected from these patients. Written informed consent was taken from all patie nts . Preanesthetic medication was given with Ranitidine 150mg and Lorazepam 1mg, the night before and morning of surgery. Patients were randomly allocated into 2 groups. Group A - R eceived Inj. Ondansetron 8mg diluted in 5ml of normal saline . Group B - R ec eived Inj. Granisetron 1mg diluted in 5ml of normal saline . INJ. Glycopyrolate 0.01mg/kg & INJ. Fentanyl (1 - 2μ/Kg given intravenously 5min prior to induction of anaesthesia. All the vital data values recorded before & throughout surgery at 15 min interval for 2 hours. Patients were observed at 0 - 2hrs, 2 - 6hrs, 6 - 12hrs post operatively for episodes of PONV. RESULTS: At the end of the study , a complete response i.e., no PONV and no need for another rescue antiemetic was attained in 92 % of patients who received Granisetron and 68% of patients who received Ondansetron. No differences in adverse events were observed in the two groups. CONCLUSION: The incidence of PONV after laparoscopic cholecystectomy is large. In view of the proven advan tage of serotonin antagonists, we decided to study the antiemetic efficacy of Granisetron. After premedication, patients were administered the study drugs intravenously prior to the induction and balanced general anaesthesia was administered. Patients were observed for nausea and vomiting after the procedure at 0 - 2hrs, 2 - 6

  19. A Hospital Based Clinical Study on Corneal Blindness in a Tertiary Eye Care Centre in North Telangana

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    Raghu Veladanda

    2016-04-01

    Full Text Available Background: Worldwide there are nearly 2.7 million blind people due to corneal disease which is a major causes of blindness in the world today and remains second only to cataract. Aim & Objective: The present hospital based retrospective study was undertaken to estimate the prevalence of corneal blindness in patients attending tertiary eye care center in Chalmeda Anand Rao Institute of Medical Sciences, Karimnagar. Material and Methods: A hospital-based study was conducted over a period of 1 year from August 2014 to August 2015. Participants were patients attending outpatient department of Chalmeda Anand Rao Institute of Medical Sciences. Detailed history was taken and comprehensive ocular examination including Snellen E-chart for visual acuity, slit lamp bio microscopy, contact tonometry, posterior segment evaluation through B-scan and dilated retinal evaluation when indicated was performed at out patient department. Results: Overall, 33,566 patients were examined. Proportion of corneal blindness was 3.9% (CI-95% 3.6% - 4.3%. The proportion increased with age in elderly patients (5.7% and was higher among the females (5.2% compared to males (2.8%. The most common cause of corneal blindness in our study was ocular trauma which was 59.5%. Conclusion: The study ?findings demonstrate that currently ocular trauma, corneal ulceration, infectious keratitis, postsurgical bullous keratopathy, and corneal degenerations are responsible for the major burden of corneal blindness among the patients attending outpatient department.

  20. An experimental double-blind irradiation study of a novel topical product (TPF 50) compared to other topical products with DNA repair enzymes, antioxidants, and growth factors with sunscreens: implications for preventing skin aging and cancer.

    Science.gov (United States)

    Emanuele, Enzo; Spencer, James M; Braun, Martin

    2014-03-01

    The exposure to ultraviolet radiation (UVR) is a major risk factor for skin aging and the development of non-melanoma skin cancer (NMSC). Although traditional sunscreens remain the mainstay for the prevention of UVR-induced skin damage, they cannot ensure a complete protection against the whole spectrum of molecular lesions associated with UVR exposure. The formation of helix-distorting photoproducts such as cyclobutane pyrimidine dimers (CPD), as well as oxidative damage to DNA bases, including the formation of 8-oxo-7,8-dihydro-2'-deoxyguanosine (8OHdG) are among the key DNA lesions associated with photoaging and tumorigenesis. Besides DNA lesions, UVR-induced formation of free radicals can result in protein carbonylation (PC), a major form of irreversible protein damage that inactivates their biological function. This study compares a complex novel topical product (TPF50) consisting of three actives, ie, 1) traditional physical sunscreens (SPF 50), 2) a liposome-encapsulated DNA repair enzymes complex (photolyase, endonuclease, and 8-oxoguanine glycosylase [OGG1]), and 3) a potent antioxidant complex (carnosine, arazine, ergothionine) to existing products. Specifically, we assessed the ability of TFP50 vs those of DNA repair and antioxidant and growth factor topical products used with SPF 50 sunscreens in preventing CPD, 8OHdG, and PC formation in human skin biopsies after experimental irradiations. In head-to-head comparison studies, TPF50 showed the best efficacy in reducing all of the three molecular markers. The results indicated that the three TPF50 components had a synergistic effect in reducing CPD and PC, but not 8OHdG. Taken together, our results indicate that TPF50 improves the genomic and proteomic integrity of skin cells after repeated exposure to UVR, ultimately reducing the risk of skin aging and NMSC.

  1. A highly efficacious pediculicide based on dimeticone: Randomized observer blinded comparative trial

    Directory of Open Access Journals (Sweden)

    Oliveira Fabíola A

    2008-09-01

    Full Text Available Abstract Background Infestation with the human head louse (Pediculus humanus capitis occurs worldwide. Existing treatment options are limited, and reports of resistance to commonly used pediculicides have been increasing. In this trial we assessed the efficacy of a product containing a high (92% concentration of the silicone oil dimeticone (identical in composition to NYDA®, as compared to a 1% permethrin lotion. Methods Randomized, controlled, observer blinded clinical trial. Participants were recruited from a poor urban neighbourhood in Brazil where pediculosis capitis was highly prevalent. To minimize reinfestation during the trial, participants (145 children aged 5–15 years with head lice infestations were transferred to a holiday resort outside the endemic area for a period of 9 days. Two applications of dimeticone or 1% permethrin were done, seven days apart. Outcome measures were defined as cure (absence of vital head lice after first application and before and after second applications, degree of itching, cosmetic acceptability, and clinical pathology. Results Overall cure rates were: day 2 – dimeticone 94.5% (95% CI: 86.6% – 98.5% and permethrin 66.7% (95% CI: 54.6% – 77.3%; p Conclusion The dimeticone product is a safe and highly efficacious pediculicide. Due to its physical mode of action (interruption of the lice's oxygen supply of the central nervous system, development of resistance is unlikely. Trial registration Current Controlled Trials ISRCTN15117709.

  2. 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.

  3. 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.

  4. 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…

  5. Treatment of patients with Schistosomiasis mansoni: a double blind clinical trial comparing praziquantel with oxamniquine

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    Luiz Caetano da Silva

    1986-06-01

    Full Text Available A double-blind clinical trial involving 120 patients with chronic schistosomiasis was carried out to compare the tolerability and efficacy of praziquantel and oxamniquine. The patients were randomly allocated into two groups. One was treated with praziquantel, 55 mg/kg of body weight CBWT, and the other one with oxamniquine, 15mg/kg bwt, administered in a single oral dose. The diagnosis and the parasitological follow-up was based on stool examinations by quantitative Kato-Katz method and on rectal biopsies. Side-effects — mainly dizziness, sleepness, abdominal distress, headache, nausea and diarrhea — were observed in 87% of the cases. Their incidence, intensity and duration were similar for both drugs but abdominal pain was significantly more frequent after praziquantel intake and severe dizziness was more commonly reported after oxamniquine. A significant increase of alanine-aminotransferase and y-glutamyltransferase was found with the latter drug and of total bilirubin with the former one. A total of 48 patients treated with praziquantel and 46 with oxamniquine completed with negative findings the required three post-treatment parasitological controls — three slides of each stool sample on the first, third and sixth month. The achieved cure rates were 79.2% and 84.8%, respectively, a difference without statistical significance. The non-cured cases showed a mean reduction in the number of eggs per gram of feces of 93.5% after praziquantel and of 84.1% after oxamniquine. This diference also was not significant. Five patients retreated with praziquantel were cured but only one out of three treated a second time with oxamniquine. These findings show that both drugs — despite their different chemical structures, pharmacological properties and mechanisms-of-action — induce similar side-effects as well as a comparable therapeutical efficacy, in agreement with the results reported from analogous investigations.

  6. 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

  7. Pain after microlaparoscopic cholecystectomy. A randomized double-blind controlled study

    DEFF Research Database (Denmark)

    Bisgaard, T; Klarskov, B; Trap, R;

    2000-01-01

    BACKGROUND: Laparoscopic cholecystectomy (LC) is traditionally performed with two 10-mm and two 5-mm trocars. The effect of smaller port incisions on pain has not been established in controlled studies. METHODS: In a double-blind controlled study, patients were randomized to LC or cholecystectomy......: The study was discontinued after inclusion of 26 patients because five of the 13 patients (38%) randomized to micro-LC were converted to LC. In the remaining 21 patients, overall pain and incisional pain intensity during the first 3 h postoperatively increased in the LC group (n = 13) compared...

  8. Comparative waste forms study

    Energy Technology Data Exchange (ETDEWEB)

    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. Blinded placebo crossover study of gabapentin in primary orthostatic tremor.

    Science.gov (United States)

    Rodrigues, Julian P; Edwards, Dylan J; Walters, Susan E; Byrnes, Michelle L; Thickbroom, Gary W; Stell, Rick; Mastaglia, Frank L

    2006-07-01

    Primary orthostatic tremor (OT) is a rare but disabling condition characterized by leg tremor and feelings of instability during stance. Previous studies have reported a reduction in OT symptoms with gabapentin treatment. In this study, we report on the benefits of gabapentin treatment in a double-blind placebo-controlled crossover study of 6 OT patients. First, the maximally effective gabapentin dosage (600-2,700 mg/day) for each patient was determined during an initial dose-titration phase. Patients were then studied 7 days after drug withdrawal and again after two 2-week periods of treatment with either gabapentin or placebo, using force platform posturography to quantify postural sway and tremor. Other medications for OT were continued unchanged. Symptomatic response was assessed by a patient-rated severity scale and quality of life (QOL) questionnaire. All patients reported an increase in symptoms during the washout phase and symptom reduction (50%-75%) during gabapentin treatment. Tremor amplitude was reduced to 79% +/- 11% and sway area to 71% +/- 11% of the placebo state. QOL improved in all patients, no adverse drug effects were noted, and symptomatic benefit was maintained at follow-up (mean = 19 months). The findings confirm that gabapentin is an effective treatment for OT, reducing both tremor and postural instability and improving quality of life, and support its use as add-on or first-line therapy for OT.

  10. 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.

    Science.gov (United States)

    Gupta, Devendra; Srivastava, Shashi; Dubey, Rajeev K; Prakash, Prabhakar S; Singh, Prabhat K; Singh, Uttam

    2011-03-01

    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 (Pclonidine 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.

  11. 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.

  12. COMPARATIVE EVALUATION OF ORALLY DISINTEGRATING FILM OF ONDANSETRON VERSUS INTRAVENOUS GRANISETRON IN PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING FOLLOWING LAPAROSCOPIC CHOLECYSTECTOMY: A PROSPECTIVE, RANDOMIZED DOUBLE - BLIND PLACEBO - CONTROLLED STUDY

    OpenAIRE

    2015-01-01

    BACKGROUND : Ondansetron and granisetron are first generation 5 - hydroxytry - ptamine - 3 (5 - HT3) receptor antagonists widely used in the prophylaxis of postoperative nausea and vomiting (PONV). Orally Disintegrating Film (ODF) formulations are novel and advanced oral drug delivery systems used in management of (PONV). We aimed to study the efficacy of ODF of Ondansetron in the prophylaxis of PONV and to co...

  13. 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

  14. Ozone treatment of recurrent aphthous stomatitis: a double blinded study.

    Science.gov (United States)

    Al-Omiri, Mahmoud K; Alhijawi, Mohannad; AlZarea, Bader K; Abul Hassan, Ra'ed S; Lynch, Edward

    2016-06-15

    This study aimed to evaluate the use of ozone to treat recurrent aphthous stomatitis (RAS). Consecutive sixty-nine participants with RAS were recruited into this non-randomized double blind, controlled cohort observational study (test group). A control group of 69 RAS patients who matched test group with age and gender was recruited. RAS lesions in test group were exposed to ozone in air for 60 seconds while controls received only air. Ulcer size and pain were recorded for each participant at baseline and daily for 15 days. Ulcer duration was determined by recording the time taken for ulcers to disappear. The main outcome measures were pain due to the ulcer, ulcer size and ulcer duration. 138 RAS participants (69 participants and 69 controls) were analyzed. Ulcer size was reduced starting from the second day in test group and from the fourth day in controls (p ≤ 0.004). Pain levels were reduced starting from the first day in the test group and from the third day in controls (p ≤ 0.001). Ulcer duration, ulcer size after day 2 and pain levels were more reduced in the test group. In conclusion, application of ozone on RAS lesions for 60 seconds reduced pain levels and enhanced ulcers' healing by reducing ulcers' size and duration.

  15. 他克莫司治疗糜烂型OLP的随机对照双盲试验%Effect of Tacrolimus on oral lichen planus: A randomized comparative double-blind study

    Institute of Scientific and Technical Information of China (English)

    罗文平; 曾宪涛

    2013-01-01

    目的:评价0.1%他克莫司治疗糜烂型口腔扁平苔癣(OLP)的疗效和安全性.方法:根据相关标准纳入68例糜烂型OLP患者,随机分成两组,双盲法下分别外用0.1%他克莫司和0.05%丙酸氯倍他索治疗,观察和比较两组的总有效率、不良反应发生率及停药6个月后复发率.结果:他克莫司组和丙酸氯倍他索组总有效率分别为97.1%、93.9%,两组间差异无统计学意义(P>0.05);两组间复发率分别为6.5%、10.3%,差异无统计学意义(P>0.05);两组的局部不良反应发生率均较低且无显著差异(P>0.05).结论:局部外用他克莫司在改善OLP患者体征(病损面积)和症状(疼痛)方面效果显著;他克莫司治疗OLP的总有效率、治疗期间局部不良反应发生率及停药后复发率均与糖皮质激素相当.%Objective: To evaluate the treatment efficacy and safety of tacrolimus in oral clichen planus (OLP) compared with glucocorticoid. Method: 68 consecutive patients with oral lesions consistent clinically and histologically with OLP were recruited.The patients were divided into 2 groups to receive clobetasol 0.05 % or tacrolimus 0.1 % ointment and were treated for 4 weeks. Result: The Total effective rate, side-effect incidence and recurrence rates did not differ between the tacrolimus and clobetasol treatment groups (P >0.05) . separately. Conclusion: Tacrolimus could effectively both alleviate pain and reduce lesion area of patient with OPL. Total effective rate or side—effect incidence during treatment or OPL recurrence rate after stopping treatment of tacrolimus is the same with that of glucocorticoid. Further high—quality, multi—center RCTs with standard clinical evaluation are required to provide more reliable evidence.

  16. Flutrimazole shampoo 1% versus ketoconazole shampoo 2% in the treatment of pityriasis versicolor. A randomised double-blind comparative trial.

    Science.gov (United States)

    Rigopoulos, D; Gregoriou, S; Kontochristopoulos, G; Ifantides, A; Katsambas, A

    2007-05-01

    Flutrimazole is an imidazole derivative that has been proven to be efficient in superficial skin fungal infections. The aim of this randomised double-blind study was to compare for the first time, the efficiency and safety of flutrimazole 1% shampoo versus ketoconazole 2% shampoo in the treatment of tinea versicolor. Study population consisted of 60 patients with pityriasis versicolor diagnosed clinically and through direct microscopy and culture. Patients were randomly assigned to two groups: one instructed to apply flutrimazole shampoo 1% and one instructed to apply ketoconazole shampoo 2% both on head and body for 14 days. Patients were re-evaluated 14 days after the end of treatment clinically and through direct microscopy and culture. Twenty-one of 26 patients (80.8%) in the ketoconazole and 22 of 29 patients (75.9%) in the flutrimazole group had both visual healing and negative mycological evaluation. Comparison of the response between the two groups with the Yates' corrected chi-square was found statistically not significant (chi(2) = 0.19, d.f. = 1, P = 0.91). None of the patients in the two groups reported any adverse effects. Fourteen (53%) patients in the ketoconazole group and 23 (79%) in the flutrimazole group assessed the shampoos as cosmetically acceptable regarding texture, smell and foam properties. Flutrimazole shampoo 1% appears to present efficacy comparable with ketoconazole 2% in the treatment of tinea versicolor.

  17. Causes of blindness among adult Yemenis: A Hospital-based study

    Directory of Open Access Journals (Sweden)

    Al-Akily Saleh

    2008-01-01

    Full Text Available Purpose: This hospital-based retrospective study was aimed to assess the causes of blindness among adults aged 17 years and over who attended a teaching eye hospital in Yemen. Methods: The case notes of 3845 consecutive new patients over 12 months attending Ibn Al-Haitham Eye Center which is affiliated to the University of Science and Technology in Sana′a (the capital of Yemen were retrieved and analysed. Data collected included age, gender, chief complaint and complete eye examination. Results: 7.7 percent (296 were uniocularly blind and 11.2 percent (432 were binocularly blind (best corrected visual acuity < 3/60 in the better eye. The leading causes of uniocular blindness were cataract, trauma related ocular complications, corneal opacity, amblyopia and glaucoma. Binocular blindness was mainly due to cataract, glaucoma, diabetic retinopathy, age related macular degeneration and corneal opacity. Conclusions: These data imply that the preliminary results give us some insight about the magnitude of the problem of blindness in Yemen while awaiting a national survey on the prevalence and causes of blindness. Cataract was found to be the main cause of unilateral and bilateral blindness and this will require surgical relief, either in public hospitals, private hospitals and clinics, or in eye camps. Trauma related ocular complications were found to be the second most common cause of uniocular blindness. Health education, implementing work safety measures and bringing ophthalmological care to the doorstep of underprivileged rural community will improve their level of awareness.

  18. [Cortical blindness].

    Science.gov (United States)

    Chokron, S

    2014-02-01

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

  19. Trimipramine in primary insomnia: results of a polysomnographic double-blind controlled study.

    Science.gov (United States)

    Riemann, D; Voderholzer, U; Cohrs, S; Rodenbeck, A; Hajak, G; Rüther, E; Wiegand, M H; Laakmann, G; Baghai, T; Fischer, W; Hoffmann, M; Hohagen, F; Mayer, G; Berger, M

    2002-09-01

    In recent years, sedating antidepressants have been increasingly used to treat primary insomnia. Up to now, only one open pilot study with trimipramine and one double-blind placebo-controlled study with doxepin have provided scientific support for this approach in treating primary insomnia. In order to test the hypothesis that sedating antidepressants are useful in the treatment of primary insomnia, the effect of trimipramine on objectively and subjectively measured parameters of sleep was investigated in a double-blind placebo- and lormetazepam-controlled study in a sample of 55 patients with primary insomnia attending outpatient sleep-disorder clinics. Trimipramine was selected since it has shown positive effects on sleep continuity with a lack of REM sleep suppression in studies on depressed patients and in one pilot study on patients with primary insomnia. Trimipramine at an average dose of 100 mg over a period of 4 weeks significantly enhanced sleep efficiency, but not total sleep time (which had been the primary target variable) compared to placebo as measured by polysomnography. Changes in objective sleep parameters were paralleled by changes in subjective sleep parameters. Trimipramine did not suppress REM sleep. Lormetazepam decreased wake time and sleep stage 3 and increased REM sleep compared to placebo. After switching trimipramine to placebo, sleep parameters returned to baseline. There was no evidence of any rebound effect from trimipramine. Side effects from trimipramine were only marginal. This first double-blind placebo-controlled study with trimipramine suggests its efficacy in the treatment of primary insomnia. However, due to the large intra- and interindividual variance in the parameters of interest before and during treatment a larger sample size would have been necessary to strengthen the validity of our findings.

  20. 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

    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...

  1. 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 severit

  2. Cerebellar stimulation for cerebral palsy--double blind study.

    Science.gov (United States)

    Davis, R; Schulman, J; Delehanty, A

    1987-01-01

    Twenty spastic cerebral palsy (CP) patients undergoing chronic cerebellar stimulation (CCS) for reduction of spasticity and improvement in function have participated in a double-blind study. Seven US centers involving 9 neurosurgeons (1984-6) have replaced the depleted Neurolith 601 fully implantable pulse generator (Pacesetter Systems Incorp.-Neurodyne Corp., Sylmar, CA) with new units in 19 CP patients, 1 patient entered the study following his initial implant. A magnetically controllable switch was placed in line between the Neurolith stimulator and the cerebellar lead, so allowing switching sequences for the study. Physical therapists, living in the vicinity of the patient's home, carried out two quantitative evaluations: 1. Joint angle motion measurements (passive and active). 2. Motor performance testing was done when possible and included: reaction time, hand dynamonetry, grooved peg board placement, hand/foot tapping, and rotary pursuit testing. Testing was done presurgery, at 2 weeks postimplant, then the switch was activated either "on" or "off" to a schedule, with testing and reswitching at 1, 2 and 4 months, then the switch was left turned "on". Of the 20 patients, 16 finished the tests, 2 patients failed to finish and 2 had switch problems and were deleted from the study. Two of the 16 patients were "off" through the entire testing. Of the 14 that had periods of the stimulator being "on", 10 patients (72%) had quantitative improvements of over 20%, (1 pt: 50+% improvements; 4 pts: 30-50%, 5 pts: 20-30%); while 1 patient (7%) had improvements in the 10-20% level, whereas 3 patients (21%) showed no improvement.

  3. A comparative randomized double-blind clinical trial of isoaminile citrate and chlophedianol hydrochloride as antitussive agents.

    Science.gov (United States)

    Diwan, J; Dhand, R; Jindal, S K; Malik, S K; Sharma, P L

    1982-08-01

    The efficacy and safety of a new centrally acting antitussive agent, isoaminile citrate, was compared with that of chlophedianol hydrochloride in a double-blind, randomized interpatient study. A total of 66 patients participated, two and four patients were lost to follow-up with isoaminile and chlophedianol, respectively. In the experimentally induced cough in 12 normal human subjects, isoaminile (40 mg) was as effective as chlophedianol (20 mg), but its duration of action was somewhat longer. One subject developed allergic skin rash with chlophedianol and was withdrawn from the study. In 60 patients with cough associated with chest diseases, isoaminile (40 mg, 3 x daily) was as effective as chlophedianol (20 mg, 3 x daily) in suppressing cough as judged from the 3-h and 24-h cough counts. The increase in PEFR at day 7 of treatment was somewhat more marked with chlophedianol as compared with isoaminile. None of the drugs interfered with the expectoration process. The side effects observed were few, mild in nature, and did not require a decrease in dose or withdrawal of treatment in any of the patients. Isoaminile citrate was concluded to be an effective and relatively safe antitussive agent. Isoaminile citrate, alpha(isopropyl)-alpha-(beta-dimethylaminoproyl) phenylacetonitrile citrate, is a centrally acting antitussive agent. In animal experiments this drug was as efficacious as codeine but was devoid of any respiratory depressant effect [Krause 1958, Kuroda et al. 1971]. This controlled double-randomized interpatient study was designed to test the comparative efficacy and safety of isoaminile and chlophedianol, another centrally acting antitussive, in humans.

  4. Emotion Induced Blindness Is More Sensitive to Changes in Arousal As Compared to Valence of the Emotional Distractor

    Directory of Open Access Journals (Sweden)

    Divita Singh

    2017-08-01

    Full Text Available Emotion Induced Blindness (EIB refers to the impairment in the identification of a neutral target image that follows a threatening or fearful distractor image. It has been suggested that valence plays a significant role in driving the perceptual impairment in EIB. Recent findings from the literature suggest that arousal has a very important role in biasing early cognitive functions. Hence, in the present study, we systematically investigate the role of valence (Experiment 1 and arousal (Experiment 2 in determining the impairment in EIB. The results suggest that when valence is controlled for, the stimuli with higher arousal level lead to greater impairment in target detection. Moreover, under high arousal condition, both positive and negative stimuli lead to significantly greater impairment in target detection. Present study suggests that impairment in EIB is sensitive to the arousal component of the emotional image as compared to valence. The arousal biased competition account that explains the effect of arousal on cognitive processing can sufficiently explains the current results.

  5. A Comparative Study of Teaching Comparative Education

    OpenAIRE

    2007-01-01

    The purpose of this paper is to characterize the comparative education subjects offered in different programs in different foreign universities. As a subject, comparative education has not been firmly institutionalized in education programs in Japanese universities. There was a movement which aimed at making comparative education as one of the mandatory subjects in the teacher training program, however it was not successful. To date, comparative education subject has been offered in various p...

  6. Comparison of blind intubation through supraglottic devices and direct laryngoscopy by novices: a simulation manikin study

    Science.gov (United States)

    Kim, Young Yong; Kang, Gu Hyun; Kim, Won Hee; Choi, Hyun Young; Jang, Yong Soo; Lee, Young Jae; Kim, Jae Guk; Kim, Hyeongtae; Kim, Gyoung Yong

    2016-01-01

    Objective This study aimed to compare intubation performance between blind intubation through supraglottic airway devices and direct laryngoscopy by novices under manikin simulation. We hypothesized that the intubation time by novices using supraglottic airway devices was superior to that with the Macintosh laryngoscope (MCL). Methods A prospective, randomized crossover study was conducted with 95 participants, to evaluate i-gel, air-Q, LMA Fastrach, and MCL devices. Primary outcomes were the intubation time and the success rate for intubation. Results The i-gel showed the shortest insertion and tube passing time among the four devices; the i-gel and air-Q also showed the shortest total intubation time (all P<0.0083; i-gel vs. air-Q, P=0.03). The i-gel and MCL showed the highest cumulative success rate (all P<0.0083; i-gel vs. MCL, P=0.12). Conclusion Blind intubation through the i-gel showed almost equal intubation performance compared to direct laryngoscopy.

  7. Efficacy and tolerability of Blonanserin in the patients with schizophrenia: a randomized, double-blind, risperidone-compared trial.

    Science.gov (United States)

    Yang, Jaewon; Bahk, Won-Myong; Cho, Hyun-Sang; Jeon, Yang-Whan; Jon, Duk-In; Jung, Hee-Yeon; Kim, Chan-Hyung; Kim, Hee-Cheol; Kim, Yong-Ku; Kim, Young-Hoon; Kwon, Jun-Soo; Lee, Sang-Yeol; Lee, Seung-Hwan; Yi, Jung-Seo; Yoon, Bo-Hyun; Kim, Seung-Hyun

    2010-07-01

    The objective of this study was to evaluate the efficacy and tolerability of blonanserin for the treatment of Korean patients with schizophrenia using a double-blind risperidone-compared design. Patients aged 18 to 65 years with schizophrenia were randomly assigned to blonanserin or risperidone treatment for 8 weeks. The efficacy was assessed using the mean change in Positive and Negative Syndrome Scale score total scores from baseline to week 8. Safety assessments included monitoring of vital signs, a physical examination, laboratory tests, and adverse events. Of 206 randomly enrolled patients, 103 receiving blonanserin and 103 receiving risperidone were included in the analysis. In this study, noninferiority between blonanserin and risperidone was demonstrated. The mean change in the Positive and Negative Syndrome Scale total score at the final evaluation time point was -23.48 +/- 19.73 for the blonanserin group and -25.40 +/- 18.38 for the risperidone group. Adverse events, which occurred less frequently in the blonanserin than in the risperidone group, included dysarthria (P = 0.0288), dizziness (P = 0.0139), increased alanine aminotransferase and aspartate aminotransferase (P = 0.0095 and P = 0.0032, respectively), and increased level blood prolactin (P = 0.0012). On the other hand, the adverse events that occurred more frequently in the blonanserin than in the risperidone group was hand tremor (P = 0.0006). Blonanserin was effective in the treatment of Korean patients with schizophrenia compared with risperidone and was more tolerable with a better safety profile, particularly with respect to prolactin elevation. These findings suggest that blonanserin is useful in the treatment of schizophrenia.

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

    DEFF Research Database (Denmark)

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

    2016-01-01

    -centre blinded intervention study with crossover at three hospital departments. JN intervention of three days was randomized. Median ± standard deviation was given. The level of significance was p laugh index increased...

  9. Comparative double blind clinical trial of phenytoin and sodium valproate as anticonvulsant prophylaxis after craniotomy: efficacy, tolerability, and cognitive effects

    Science.gov (United States)

    Beenen, L; Lindeboom, J; Trenite, D; Heimans, J; Snoek, F; Touw, D; Ader, H; van Alphen, H A M

    1999-01-01

    OBJECTIVE—To determine the efficacy, tolerability, and impact on quality of life and cognitive functioning of anticonvulsant prophylaxis with phenytoin or sodium valproate in patients after craniotomy.
METHODS—A prospective, stratified, randomised, double blind single centre clinical trial was performed, comparing two groups of 50patients each, who underwent craniotomy for different pathological conditions and who were treated for 1 year after surgery with either 300 mg phenytoin/day or 1500 mg sodium valproate/day. During the study period patients were seen in the outpatient clinic at 1.5, 3, 6, and 12 months, when medical history, adverse events, and drug plasma concentrations were evaluated. Neuropsychological functioning and quality of life were assessed on the last three visits. In cases of a seizure an EEG was performed, drug plasma concentration assessed, and medication subsequently increased.
RESULTS—Of the 100 included patients 14 (seven in each group) experienced one or more postoperative seizures. Severity of the seizures was comparable in the two groups. In all patients, drug plasma concentrations were in the low or subtherapeutic ranges at the time of the first postoperative seizure. Five patients in the phenytoin group and two in the valproate group had to stop their treatment due to drug related adverse events. Sixty patients completed the 12 month period. Analysis of neuropsychological and quality of life data showed no significant differences.
CONCLUSION—For efficacy, tolerability, impact on cognitive functioning, and quality of life, no major differences were found between phenytoin and valproate prophylaxis. Valproate is an alternative for anticonvulsant prophylaxis in patients after craniotomy.

 PMID:10486394

  10. Metabarcoding is powerful yet still blind: a comparative analysis of morphological and molecular surveys of seagrass communities.

    Directory of Open Access Journals (Sweden)

    Dominique A Cowart

    and repeatable method of characterizing communities, while also presenting suggestions for improvement, including implementation of pilot studies prior to performing full "blind" metabarcoding assessments to optimize sampling and amplification protocols.

  11. Unilateral childhood blindness: a hospital-based study in Yaoundé, Cameroon

    Directory of Open Access Journals (Sweden)

    André; Omgbwa Eballe

    2009-08-01

    Full Text Available André Omgbwa Eballe1, Emilienne Epée2, Godefroy Koki2, Lucienne Bella2, Côme Ebana Mvogo21Faculty of Medicine and Pharmaceutical Sciences, University of Douala, Douala, Cameroon; 2Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, CameroonIntroduction: We performed an analytic and prospective study over a period of 12 months from January 2nd to December 31st, 2008, at the Gynaeco-Obstetric and Paediatric Hospital of Yaoundé, Cameroon. Our aim was to determine the prevalence and causes of unilateral blindness in school children aged 6 to 15 years.Results: Among the 1,266 children aged 6 to 15 years who were recruited, 60 presented with unilateral blindness (4.7%: 42 boys (6.96% and 18 girls (2.71%. The mean age was 10.15 ± 3.4 years. In patients with unilateral blindness, 65% was due to ocular trauma.Discussion: The hospital-based prevalence of unilateral blindness in children is relatively high and ocular trauma is the leading etiology.Conclusion: Unilateral blindness in school children is avoidable and its incidence could be markedly reduced by emphasizing an information strategy and education based on prevention of ocular trauma. Early management of nontraumatic diseases such as infantile glaucoma and some tumors could improve outcome and avoid blindness.Keywords: unilateral blindness, ocular trauma, prevalence, education

  12. 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.

  13. Valacyclovir for prevention of recurrent herpes labialis: 2 double-blind, placebo-controlled studies.

    Science.gov (United States)

    Baker, David; Eisen, Drore

    2003-03-01

    The oral antiviral valacyclovir, which is 3 to 5 times more bioavailable than its parent compound acyclovir, is a good candidate for effective therapy to suppress recurrent herpes labialis lesions. The efficacy of oral valacyclovir in the suppression of herpes labialis has not previously been reported. Two identical, randomized, double-blind, parallel-group studies were conducted to evaluate the efficacy of oral valacyclovir 500 mg (n=49) versus placebo (n=49) once daily for 16 weeks in the suppression of herpes labialis among patients with a history of 4 or more recurrent lesions in the previous year. Data from the studies were pooled for analysis. Twenty-eight patients (60%) in the valacyclovir group compared with only 18 patients (38%) in the placebo group were recurrence-free throughout the 4-month treatment period (P=.041). The mean time to first recurrence was significantly longer with valacyclovir (13.1 weeks) compared with placebo (9.6 weeks) (P=.016). The total number of recurrences in patients using valacyclovir was 24 compared with 41 in patients using placebo. The incidence of adverse events during the 4-month treatment period was slightly lower in the valacyclovir group (22 events, 33% of patients) compared with the placebo group (29 events, 39% of patients). The results of these small double-blind, placebo-controlled studies suggest that oral valacyclovir 500 mg once daily for 4 months is effective and well tolerated for the prevention of recurrent herpes labialis. More research with larger patient numbers is warranted to corroborate and extend these findings.

  14. Frequency of discrepancies in retracted clinical trial reports versus unretracted reports: blinded case-control study.

    Science.gov (United States)

    Cole, Graham D; Nowbar, Alexandra N; Mielewczik, Michael; Shun-Shin, Matthew J; Francis, Darrel P

    2015-09-20

    To compare the frequency of discrepancies in retracted reports of clinical trials with those in adjacent unretracted reports in the same journal. Blinded case-control study. Journals in PubMed. 50 manuscripts, classified on PubMed as retracted clinical trials, paired with 50 adjacent unretracted manuscripts from the same journals. Reports were randomly selected from PubMed in December 2012, with no restriction on publication date. Controls were the preceding unretracted clinical trial published in the same journal. All traces of retraction were removed. Three scientists, blinded to the retraction status of individual reports, reviewed all 100 trial reports for discrepancies. Discrepancies were pooled and cross checked before being counted into prespecified categories. Only then was the retraction status unblinded for analysis. Total number of discrepancies (defined as mathematically or logically contradictory statements) in each clinical trial report. Of 479 discrepancies found in the 100 trial reports, 348 were in the 50 retracted reports and 131 in the 50 unretracted reports. On average, individual retracted reports had a greater number of discrepancies than unretracted reports (median 4 (interquartile range 2-8.75) v 0 (0-5); Pretracted than those without a discrepancy (odds ratio 5.7 (95% confidence interval 2.2 to 14.5); Pretracted than unretracted reports: factual discrepancies (P=0.002), arithmetical errors (P=0.01), and missed P values (P=0.02). Results from a retrospective analysis indicated that citations and journal impact factor were unlikely to affect the result. Discrepancies in published trial reports should no longer be assumed to be unimportant. Scientists, blinded to retraction status and with no specialist skill in the field, identify significantly more discrepancies in retracted than unretracted reports of clinical trials. Discrepancies could be an early and accessible signal of unreliability in clinical trial reports. © Cole et al 2015.

  15. Randomized double blind placebo control studies, the "Gold Standard" in intervention based studies

    Directory of Open Access Journals (Sweden)

    Shobha Misra

    2012-01-01

    Full Text Available Studies follow a hierarchy in terms of the quality of evidence that they can provide. Randomized double blind placebo control (RDBPC studies are considered the "gold standard" of epidemiologic studies. And the same is discussed at length in this paper taking example of a real journal article employing this study design to answer the research question; "Does once daily dose of Valacyclovir reduce the risk of transmission of genital herpes in a susceptible partner?" RDBPC studies remain the most convincing research design in which randomly assigning the intervention can eliminate the influence of unknown or immeasurable confounding variables that may otherwise lead to biased and incorrect estimate of treatment effect. Also, randomization eliminates confounding by baseline variables and blinding eliminates confounding by co-interventions, thus eliminating the possibility that the observed effects of intervention are due to differential use of other treatments. The best comparison is placebo control that allows participants, investigators and study staff to be blinded. The advantage of trial over an observational study is the ability to demonstrate causality. Hope, this will be useful to neophyte researchers to understand causal hierarchy when critically evaluating epidemiologic literature.

  16. Randomized double blind placebo control studies, the "Gold Standard" in intervention based studies.

    Science.gov (United States)

    Misra, Shobha

    2012-07-01

    Studies follow a hierarchy in terms of the quality of evidence that they can provide. Randomized double blind placebo control (RDBPC) studies are considered the "gold standard" of epidemiologic studies. And the same is discussed at length in this paper taking example of a real journal article employing this study design to answer the research question; "Does once daily dose of Valacyclovir reduce the risk of transmission of genital herpes in a susceptible partner?" RDBPC studies remain the most convincing research design in which randomly assigning the intervention can eliminate the influence of unknown or immeasurable confounding variables that may otherwise lead to biased and incorrect estimate of treatment effect. Also, randomization eliminates confounding by baseline variables and blinding eliminates confounding by co-interventions, thus eliminating the possibility that the observed effects of intervention are due to differential use of other treatments. The best comparison is placebo control that allows participants, investigators and study staff to be blinded. The advantage of trial over an observational study is the ability to demonstrate causality. Hope, this will be useful to neophyte researchers to understand causal hierarchy when critically evaluating epidemiologic literature.

  17. Rolipram versus imipramine in inpatients with major, "minor" or atypical depressive disorder: a double-blind double-dummy study aimed at testing a novel therapeutic approach.

    Science.gov (United States)

    Bertolino, A; Crippa, D; di Dio, S; Fichte, K; Musmeci, G; Porro, V; Rapisarda, V; Sastre-y-Hernández, M; Schratzer, M

    1988-07-01

    Unlike conventional antidepressants, rolipram stimulates both the presynaptic as well as the postsynaptic component of monoaminergic transmission. Several double-blind comparative trials are on the way to assess the clinical efficacy and safety of this novel compound. The present study was a randomized double-blind double-dummy comparison with imipramine in inpatients with major, "minor" and atypical depressions (DSM III). Results show no relevant differences between rolipram and imipramine regarding efficacy and safety.

  18. Effect of Hypericum perforatum L. compared with metronidazole in bacterial vaginosis:a double-blind randomized trial

    Institute of Scientific and Technical Information of China (English)

    Sakineh; Mohammad-Alizadeh-Charandabi; Zahra; Mohammadzadeh; Azizeh; Farshbaf-Khalili; Yousef; Javadzadeh

    2014-01-01

    Objective:To compare effect of Hypericum perforatum(H.perforatum) vaginal gel with metronidazole on bacterial vaginosis(BV) in terms of initial response to treatment and preventing recurrence(primary outcomes) and also patient complaints(secondary outcomes).Methods:In this double-blind,double dummy trial,married women aged 18-49 with BV were randomized into two groups and administered 5 g of 3%H.perforatum and placebo of metronidazole(n=82),or 5 g of 0.75%metronidazole and placebo of H.peiforatum(n=80)vaginally for 5 d.Amsel criteria were used for diagnosis and assessing cure and recurrence of BV.The comparisons was done using Chi-square,Fisher’s exact and logistic regression.Results:At 10-12 d.cure rate was 82%in the H.perforatum and 85%in metronidazole group(risk ratio 0.9.95%confidence interval 0.6 to 1.3).Among the cured women,recurrence rate was 9%in the H.perforatum and 13%in the metronidazole group at the 30-35 d visit(risk ratio 0.8,95%confidence interval 0.4 to 1.3),There was no statistically significant difference between the groups regarding any patient complaints,except itching which was less in H.perforatum group(5%vs.16%,P=0.018 at the first and 13%vs.43%,P<0.001 at the second follow-up).No significant adverse event was reported at any groups.Conclusions:H.peiforatum could be a good option for treatment of BV.However,further studies arc needed for its public use.

  19. Effect of Hypericum perforatum L. compared with metronidazole in bacterial vaginosis:a double-blind randomized trial

    Institute of Scientific and Technical Information of China (English)

    Zahra Mohammadzadeh; Azizeh Farshbaf-Khalili; Yousef Javadzadeh

    2014-01-01

    Objective: To compare effect of Hypericum perforatum (H. perforatum) vaginal gel with metronidazole on bacterial vaginosis (BV) in terms of initial response to treatment and preventing recurrence (primary outcomes) and also patient complaints (secondary outcomes). Methods: In this double-blind, double dummy trial, married women aged 18-49 with BV were randomized into two groups and administered 5 g of 3% H. perforatum and placebo of metronidazole (n=82), or 5 g of 0.75% metronidazole and placebo of H. perforatum (n=80) vaginally for 5 d. Amsel criteria were used for diagnosis and assessing cure and recurrence of BV. The comparisons was done using Chi-square, Fisher's exact and logistic regression.Results:At 10-12 d, cure rate was 82% in the H. perforatum and 85% in metronidazole group (risk ratio 0.9, 95% confidence interval 0.6 to 1.3). Among the cured women, recurrence rate was 9%in the H. perforatum and 13% in the metronidazole group at the 30-35 d visit (risk ratio 0.8, 95%confidence interval 0.4 to 1.3). There was no statistically significant difference between the groups regarding any patient complaints, except itching which was less in H. perforatum group (5% vs. 16%, P=0.018 at the first and 13% vs. 43%, P<0.001 at the second follow-up). No significant adverse event was reported at any groups. Conclusions: H. perforatum could be a good option for treatment of BV. However, further studies are needed for its public use.

  20. Body image and restrained eating in blind and sighted women: A preliminary study.

    Science.gov (United States)

    Ashikali, Eleni-Marina; Dittmar, Helga

    2010-03-01

    Sociocultural theory attributes the high levels of body image concerns and disordered eating in Western women to the promotion of an unrealistically thin body ideal. This study investigated body dissatisfaction, restrained eating, and attitudes toward appearance in visually impaired and sighted women. There were 21 congenitally blind, 11 blinded later in life, and 60 sighted. Blind women were more satisfied with their body and dieted less than sighted women. Appearance attitudes, particularly thin-ideal internalization, accounted for differences in body dissatisfaction and dieting among the three groups of women. Possible explanations for our findings are considered, including the importance of visual exposure to the media's thin ideal, as well as the usefulness of future research on blind women. Copyright 2010 Elsevier Ltd. All rights reserved.

  1. As World's Population Ages, Blindness Rates Likely to Grow

    Science.gov (United States)

    ... medlineplus.gov/news/fullstory_167592.html As World's Population Ages, Blindness Rates Likely to Grow Study of ... estimate that 0.75 percent of the world's population was blind in 1990, compared to 0.5 ...

  2. A double blind controlled study of propranolol and cyproheptadine in migraine prophylaxis.

    Directory of Open Access Journals (Sweden)

    Rao B

    2000-07-01

    Full Text Available Role of propranolol and cyproheptadine in the prophylaxis of migraine was studied in a controlled double blind trial. Two hundred fifty-nine patients were divided into four groups. Each group was either given a placebo, cyproheptadine, propranolol or a combination of the latter two drugs. The patients were followed for a period of three months. Significant relief in frequency, duration and severity from migranous attacks was seen in all drug treated groups over placebo. Significant correlation in response was seen in frequency, duration and severity in all the groups which received drugs. Statistically more significant relief was seen in cyproheptadine and propranolol treated group as compared to individual drug treated groups. In cyproheptadine and propranolol treated groups, the dropout rate was lower and associated symptoms were better relieved than in other groups. The study shows efficacy of combination of cyproheptadine and propranolol in migraine prophylaxis.

  3. 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.

  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

    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...

  5. [Treatment of Meniere disease with betahistine dimesilate (Aequamen)--double-blind study versus placebo (crossover)].

    Science.gov (United States)

    Meyer, E D

    1985-05-01

    The efficacy of treatment of Menière's disease was investigated in 2 double blind study versus placebo. Forty patients were given 36 mg betahistine dimesilate daily for at least six weeks. The course of disease and findings one year before and one year after the treatment were noted and compared for assessing the therapeutic success. The findings on threshold audiograms, spontaneous and provoked nystagmus and caloric tests did not show any significant changes. A slight improvement was noted in the low frequency range of threshold audiograms. Dizziness, tinnitus and disturbances of walking were significantly improved. The incidence of vertigo attacks was reduced to 64%. In 89% of the patients no further vertigo attacks were seen after the treatment. The best results of betahistine dimesilate treatment were observed in the early stages of Menière's disease.

  6. The effects of mesterolone, a male sex hormone in depressed patients (a double blind controlled study).

    Science.gov (United States)

    Itil, T M; Michael, S T; Shapiro, D M; Itil, K Z

    1984-06-01

    Based on computer EEG (CEEG) profiles, in high doses, antidepressant properties of mesterolone, a synthetic androgen, were predicted. In a double-blind placebo controlled study, the clinical effects of 300-450 mg daily mesterolone were investigated in 52 relatively young (age range 26-53 years, mean 42.7 years) male depressed outpatients. During 6 weeks of mesterolone treatment, there was a significant improvement of depressive symptomatology. However, since an improvement was also established during the placebo treatment, no statistically appreciable difference in the therapeutic effects of mesterolone was established compared to placebo. Mesterolone treatment significantly decreased both plasma testosterone and protein bound testosterone levels. Patients with high testosterone levels prior to treatment seem to have had more benefit from mesterolone treatment than patients with low testosterone levels. The degree of improvement weakly correlated to the decrease of testosterone levels during mesterolone treatment.

  7. Efficacy and safety of monotherapy with the novel sodium/glucose cotransporter-2 inhibitor tofogliflozin in Japanese patients with type 2 diabetes mellitus: a combined Phase 2 and 3 randomized, placebo-controlled, double-blind, parallel-group comparative study.

    Science.gov (United States)

    Kaku, Kohei; Watada, Hirotaka; Iwamoto, Yasuhiko; Utsunomiya, Kazunori; Terauchi, Yasuo; Tobe, Kazuyuki; Tanizawa, Yukio; Araki, Eiichi; Ueda, Masamichi; Suganami, Hideki; Watanabe, Daisuke

    2014-03-28

    In recent years, several oral antidiabetic drugs with new mechanisms of action have become available, expanding the number of treatment options. Sodium/glucose cotransporter-2 (SGLT2) inhibitors are a new class of oral antidiabetic drugs with an insulin-independent mechanism promoting urinary glucose excretion. We report the results of a combined Phase 2 and 3 clinical study (Japic CTI-101349) of the SGLT2 inhibitor tofogliflozin (CSG452, RG7201) in Japanese patients with type 2 diabetes mellitus. The efficacy and safety of tofogliflozin were assessed in this multicenter, placebo-controlled, randomized, double-blind parallel-group study involving 230 patients with type 2 diabetes mellitus with inadequate glycemic control on diet/exercise therapy. Between 30 October 2010 and 28 February 2012, patients at 33 centers were randomized to either placebo (n = 56) or tofogliflozin (10, 20, or 40 mg; n = 58 each) orally, once daily for 24 weeks. The primary efficacy endpoint was the change from baseline in HbA1c at week 24. Overall, 229 patients were included in the full analysis set (placebo: n = 56; tofogliflozin 10 mg: n = 57; tofogliflozin 20 and 40 mg: n = 58 each). The least squares (LS) mean change (95% confidence interval) from baseline in HbA1c at week 24 was -0.028% (-0.192 to 0.137) in the placebo group, compared with -0.797% (-0.960 to -0.634) in the tofogliflozin 10 mg group, -1.017% (-1.178 to -0.856) in the tofogliflozin 20 mg group, and -0.870% (-1.031 to -0.709) in the tofogliflozin 40 mg group (p Japanese patients with type 2 diabetes mellitus. Phase 3 studies were recently completed and support the findings of this combined Phase 2 and 3 study. This study was registered in the JAPIC clinical trials registry (ID: Japic CTI-101349).

  8. Study of efficacy and safety of a new local cream ("healer" in the treatment of chronic anal fissure: a prospective, randomized, single-blind, comparative study Estudo da eficácia e segurança de novo creme cicatrizante para o tratamento da fissura anal crônica: estudo prospectivo, randomizado, simples-cego e comparativo

    Directory of Open Access Journals (Sweden)

    Mostafa Yakoot

    2009-09-01

    Full Text Available OBJECTIVES: To determine the efficacy and safety of "healer" cream as monotherapy in the treatment of acute and chronic anal fissure. STUDY DESIGN: A prospective, randomized, single blinded, comparative trial. METHODS: Sixty patients suffering from anal fissure were included in the study. Patients were randomly divided into three groups: group A: treated with "healer" local cream application 3 times daily; group B: treated with nitroglycerine 0.25% local cream 3 times daily; group C: treated with a lidocaine 2% cream applied locally 3 times daily. All the followings were followed up and compared between groups. (1 Visual pain analogue score after defecation; (2 severity of straining and discomfort during defecation; (3 frequency of ulcer healed at 30 days; (4 any side effects or complications. RESULTS: The pain scoring after defecation was significantly reduced in the three treatment groups. The group treated with "healer" isosorbide-di-nitrate showed the greatest reduction of the visual pain analogue score median from 9 before treatment to 3 & 1 after 10 and 20 days respectively, while the median visual pain analogue score in group B treated with nitroglycerine cream was 9 reduced to 4 & 2 after 10 and 20 days respectively, and the median visual pain analogue score in lidocaine group only dropped from 9 to 6 and 4, respectively. The reduction of both pain scoring and defecation scoring with "healer" was statistically significantly greater than the other two treatments by Kruskal-Wallis test, POBJETIVOS: Determinar a eficácia e segurança de "creme cicatrizante" (dinitrato de isosorbida 1%; lidocaína 2%; rutosídios 5% em base de creme anti-séptico como monoterapia no tratamento da fissura anal aguda ou crônica. METODOLOGIA: Estudo prospectivo, randomizado, simples-cego, comparativo. Foram incluídos 60 pacientes com fissura anal. Foram divididos randomicamente em três grupos: grupo A: tratados com "creme cicatrizante", grupo B: tratados

  9. Effectiveness evaluation of an integrated automatic termomechanic massage system (SMATH® system in non-specific sub-acute and chronic low back pain - a randomized double-blinded controlled trial, comparing SMATH therapy versus sham therapy: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Mazzolari Rita

    2011-10-01

    Full Text Available Abstract Background Low back pain (LBP is a major health problem in modern society, with 70-85% of the population experiencing LBP at some time in their lives. Each year, 5-10% of the workforce misses work due to LBP, most for less than 7 days. Almost 10% of all patients are at risk of developing chronic pain and disability. Little clinical evidence is available for the majority of treatments used in LBP therapy. However, moderate evidence exists for interdisciplinary rehabilitation, exercise, acupuncture, spinal manipulation, and cognitive behavioral therapy for subacute and chronic LBP. The SMATH® system (system for automatic thermomechanic massage in health is a new medical device (MD that combines basic principles of mechanical massage, thermotherapy, acupressure, infrared therapy, and moxibustion. SMATH® is suitable for automatic multidisciplinary treatment on patients with non-specific sub-acute and chronic LBP. Methods/design This paper describes the protocol for a double-blinded, sham-controlled, randomized, single-center short term clinical trial in patients with non-specific sub-acute and chronic LBP aged 18 to 70 years. The primary outcome will be the effectiveness of SMATH® versus sham therapy (medical device without active principles determined by evaluating self perceived physical function with Roland Morris Disability Questionnaire (RMDQ scores after 4 weeks of treatment (end of treatment. Major secondary outcome will be effectiveness of SMATH® determined by evaluating self perceived physical function comparing RMDQ scores between end of treatment and baseline. The trial part of the study will take 7 months while observational follow-up will take 11 months. The sample size will be 72 participants (36 for each arm. The project has been approved by the Ethical Committee of Cremona Hospital, Italy on 29 November 2010. Discussion Compared to other medical specialties, physical and rehabilitation medicine (PRM has not yet received

  10. 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.

  11. A double-blind comparative study of the effects of a 23-day oral contraceptive regimen with 20 microg ethinyl estradiol and 75 microg gestodene and a 21-day regimen with 30 microg ethinyl estradiol and 75 microg gestodene on hemostatic variables, lipids, and carbohydrate metabolism.

    Science.gov (United States)

    Endrikat, J; Klipping, C; Gerlinger, C; Ruebig, A; Schmidt, W; Holler, T; Düsterberg, B

    2001-10-01

    In this double-blind study we compared the influence of two oral contraceptives, a 23-day regimen with 20 microg ethinyl estradiol and 75 microg gestodene (23-day 20/75) and a 21-day regimen with 30 microg ethinyl estradiol and 75 microg gestodene (21-day 30/75), on hemostatic variables, lipids, and carbohydrate metabolism. The volunteers received the preparations daily for six 28-day cycles. Hemostatic variables and lipids were measured at baseline and after six treatment cycles. Carbohydrate metabolism was assessed by determination of the area under the curve (AUC) of carbohydrate parameters after oral glucose tolerance tests performed at baseline and after three treatment cycles. Data from 33 volunteers in each group were obtained. No significant differences between the effects of both treatments on the hemostatic system were detected. Neither the overall change of all hemostatic variables from baseline to treatment Cycle 6 [defined as primary target variable in the study] nor the change of any of the individual hemostatic parameters differed significantly between the treatment groups. Likewise, no significant nor clinically relevant differences in the effects of both treatments on the volunteers' lipid profiles were detected. The data on carbohydrate variables suggested a slightly more favorable influence of the 23-day 20/75 regimen. The increase of the glucose AUCs after three cycles tended to be stronger with the 21-day 30/75 regimen than with the 23-day 20/75 regimen. In addition, the AUCs for insulin and C-peptide were slightly reduced after three cycles with the 23-day 20/75 regimen but slightly increased with the 21-day 30/75 regimen. Both study treatments were safe and well tolerated by the volunteers as shown by the nature and frequency of adverse events, the routine laboratory examinations, and the physical and gynecological examinations. Both preparations provided adequate contraceptive reliability. The only pregnancy during treatment was attributable

  12. Visual impairment and blindness in type 2 diabetics: Ife-Ijesa diabetic retinopathy study.

    Science.gov (United States)

    Onakpoya, O H; Kolawole, B A; Adeoye, A O; Adegbehingbe, B O; Laoye, O

    2016-08-01

    Diabetes and blindness are important health issues globally; we determined the prevalence of blindness, diabetic retinopathy, and other eye diseases in Nigerian-type 2 diabetics. A prospective, cross-sectional study was conducted on consenting type 2 diabetic patients who had scheduled comprehensive eye examination including dilated funduscopy with +78DS. Visual status was graded using the WHO criteria. Approval from Institutional Ethics Committee was obtained. Primary outcome measures were the prevalence and causes of blindness as well as prevalence of diabetic retinopathy. Secondary outcome measures were the presence of other eye diseases. Data were analyzed using SPSS version 13. Two hundred and sixty-six eyes of 133 type 2 diabetic patients aged 22-89 years were studied; 69 (51.9 %) were males while 64 (48.1 %) were females. Five (3.8 %) patients were blind while 27 (20.3 %) were visually impaired. Cataract was the leading cause of blindness (60 %) and visual impairment was found in 59.3 %. Diabetic retinopathy was present in 37 (27.8 %) diabetic patients of which 5 (3.8 %) were proliferative. Diabetic macular edema was present in 31 (23.3 %) patients. Severe visual impairment and blindness were commoner in those with diabetic retinopathy. Refractive error 67 (25.2 %), cataract 63 (23.7 %), and chronic glaucoma 44 (16.5 %) were the most prevalent non-diabetic retinopathy eye diseases. High prevalence of blindness, diabetic retinopathy, and other diseases are seen in type 2 diabetics. Health education, early diagnosis as well as treatment of diabetic retinopathy and other diseases will largely alleviate these ocular morbidities.

  13. Patient Satisfaction With Propofol for Outpatient Colonoscopy: A Prospective, Randomized, Double-Blind Study.

    Science.gov (United States)

    Padmanabhan, Anantha; Frangopoulos, Christoforos; Shaffer, Lynn E T

    2017-10-01

    Previous literature has shown that propofol has ideal anesthetic properties for patients undergoing colonoscopy, a common procedure at outpatient surgery centers. However, there is a paucity of information regarding patient satisfaction with propofol. The aim of this study was to evaluate patient satisfaction with propofol compared with nonpropofol (fentanyl/midazolam) anesthesia for outpatient colonoscopies. Safety and complications were secondary end points. This study was a double-blind, randomized, parallel-group controlled clinical trial (NCT 02937506). This study was conducted at a single ambulatory surgery center at an urban teaching community health system. Patients were scheduled for outpatient colonoscopy. Those with high-risk cardiac or pulmonary disease were excluded. Anesthesia personnel administered either fentanyl/midazolam (n = 300) or propofol (n = 300) for sedation during outpatient colonoscopy. A single, highly experienced endoscopist performed all colonoscopies. The primary outcomes measured were patient satisfaction (5-point Likert scale) and procedure complications. Data were collected on the day of endoscopy by the nursing staff of the postanesthesia care unit. A subinvestigator blinded to the randomization called patients 24 to 72 hours after discharge to obtain data on postprocedure problems and status of resumption of normal activities. Analysis was intention-to-treat. Fewer patients who received propofol remembered being awake during the procedure (2% vs 17% for fentanyl, p propofol (p propofol group (2.7% vs 11.7%, p propofol over a combination of fentanyl/midazolam as their anesthetic for outpatient colonoscopies. From a patient and provider perspective, propofol appears to be superior to fentanyl/midazolam for outpatient colonoscopy. See Video Abstract at http://links.lww.com/DCR/A445.

  14. A Study on Prevalence of Phenyl Thiocarbamide (PTC) Taste Blindness Among Obese Individuals.

    Science.gov (United States)

    Veluswami, Deepika; Meena, B Ambigai; Latha, S; Fathima, I Gayathri; Soundariya, K; Selvi, K Senthamil

    2015-05-01

    Taste blindness to the phenylthiocarbamide (PTC) is an inherited trait that is shown to influence our food and dietary preferences which in turn influence our body weight. Obesity is a global epidemic issue known to be on rise among the developing countries. Relating taste perception to obesity, the present study was undertaken to assess the prevalence of phenylthiocarbamide (PTC) taste blindness among obese individuals. Three hundred and fifty individuals of age group 20-40 y were recruited from the local community for the present cross sectional study. Anthropometric measurements were taken and BMI was calculated. Subjects were classified as underweight, normal, overweight and obese based on their BMI. Normal, overweight and obese individuals were then asked to taste the commercially available PTC test papers and classified as non tasters and tasters of PTC. Out of 350 individuals, mean age group of 30±6.02 y, based on their BMI they were divided into 4 groups, Group A-underweight (16%), Group B-normal (35%), Group C-overweight (28%) and Group D-obese (21%) individuals. In group B, 28% were non tasters of PTC and 65% were tasters. In group C, 82% were non tasters and 13% were tasters and in Group D, 81% were non tasters and 19% were tasters of PTC. The PTC non taster phenotype individuals showed higher BMI as compared with the tasters' phenotype. Exploring the novel connections between taste perception and obesity would help us to gain a control over the global epidemic-Obesity, which is the crux factor for various other health problems. The study advocates the usage of PTC tasting as a reliable indicator of weight gain susceptibility.

  15. Regulatory forum opinion piece: blind reading of histopathology slides in general toxicology studies.

    Science.gov (United States)

    Neef, Natasha; Nikula, Kristen J; Francke-Carroll, Sabine; Boone, Laura

    2012-06-01

    With the intention of reducing bias, a recent European Food Safety Authority draft guidance document included a recommendation for blinded evaluation of histopathology slides in general toxicology studies (EFSA 2011). Although blinding as to treatment status reduces bias in many types of scientific experiment and is sometimes also appropriate in toxicologic pathology (Holland and Holland 2011), it is most unlikely to help achieve the overall goal of improved human safety when used for routine histopathology evaluation of tissues in general toxicology studies. This is the case because (1) blinding is not applicable to the inductive reasoning process used to identify test article effects in the tissues and would dramatically reduce the chances of these being successfully identified; and (2) in any case, the bias that would be reduced by blinding is actually a bias favoring diagnosis of a toxicological hazard and a conservative safety evaluation, which is appropriate in this context. Other unintended consequences of blinding histopathology evaluation include reductions in sensitivity for a variety of additional reasons and increased subjectivity of the pathology data.

  16. Inclusion of blind children in primary schools : a case study of teachers’ opinions in Moroto district-Uganda

    OpenAIRE

    Igune, George William

    2009-01-01

    The study investigated the teachers’ opinions about inclusion of children who are blind; the factors which may influence their opinions and what they think can be done to include children who are blind in primary schools. It was a qualitative study which purposely involved five teachers from two primary schools. Data was collected through interviews. The centre of interest in the study was on the acceptance of children who are blind by the teachers; participation of children who are blin...

  17. A randomised, assessor blind, parallel group comparative efficacy trial of three products for the treatment of head lice in children - melaleuca oil and lavender oil, pyrethrins and piperonyl butoxide, and a "suffocation" product

    OpenAIRE

    Barker Stephen C; Altman Phillip M

    2010-01-01

    Abstract Background There are many different types of pediculicides available OTC in Australia. In this study we compare the efficacy and safety of three topical pediculicides: a pediculicide containing melaleuca oil (tea tree oil) and lavender oil (TTO/LO); a head lice "suffocation" product; and a product containing pyrethrins and piperonyl butoxide (P/PB). Method This study was a randomised, assessor-blind, comparative, parallel study of 123 subjects with live head lice. The head lice produ...

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

    NARCIS (Netherlands)

    denBoer, JA; Westenberg, HGM; Pian, KLH

    1997-01-01

    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

  19. A review of intervention studies on teaching AAC to individuals who are deaf and blind

    NARCIS (Netherlands)

    Sigafoos, J.; Didden, H.C.M.; Schlosser, R.; Green, V.A.; O'Reilly, M.F.; Lancioni, G.E.

    2008-01-01

    We reviewed intervention studies on teaching augmentative and alternative communication (AAC) to deaf–blind individuals. Studies meeting pre-determined inclusion-exclusion criteria were identified through electronic databases and hand searching and were summarized in terms of: (a) participants, (b)

  20. Do People Who Became Blind Early in Life Develop a Better Sense of Smell? A Psychophysical Study

    Science.gov (United States)

    Cuevas, Isabel; Plaza, Paula; Rombaux, Phillippe; Collignon, Olivier; De Volder, Anne G.; Renier, Laurent

    2010-01-01

    Using a set of psychophysical tests, we compared the olfactory abilities of 8 persons who became blind early in life and 16 sighted persons in a control group who were matched for age, sex, and handedness. The results indicated that those who became blind early in life developed compensatory perceptual mechanisms in the olfactory domain that…

  1. Transient cortical blindness: a benign but devastating complication after coronary angiography and graft study.

    Science.gov (United States)

    Sridhar, Ganiga Srinivasaiah; Sadiq, Muhammad Athar; Wan Ahmad, Wan Azman; Supuramaniam, Chitra; Undok, Abdul Wahab; Abidin, Imran Zainal; Chee, Kok Han

    2014-10-01

    Transient cortical blindness after coronary angiography and bypass graft is a very rare complication. In this report we present the case of a 63-year-old man who developed transient cortical blindness within 30 minutes of coronary angioplasty and graft study, but subsequently recovered within 72 hours without any neurological deficit. A plain computed tomography brain scan showed bilateral symmetrical subarachnoid hyperdensities in the posterior cerebral circulation area suspicious of subarachnoid bleed. However, magnetic resonance imaging and magnetic resonance angiography scans were normal. Excess contrast volume causing direct neurotoxicity seems to be the most probable cause, but the exact mechanism is unclear.

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

    Energy Technology Data Exchange (ETDEWEB)

    Stokland, E.; Jacobsson, B.; Ljung, B. [Dept. of Paediatric Radiology and Clinical Physiology, The Queen Silvia Children' s Hospital, Gothenburg (Sweden); Andreasson, S. [Dept. of Paediatric Anaesthesiology, The Queen Silvia Children' s Hospital, Gothenburg (Sweden); Jodal, U. [Dept. of Paediatrics, The Queen Silvia Children' s Hospital, Gothenburg (Sweden)

    2003-04-01

    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.)

  3. [Preemptive randomized, double-blind study with lornoxicam in gynecological surgery].

    Science.gov (United States)

    Trampitsch, E; Pipam, W; Moertl, M; Sadjak, A; Dorn, C; Sittl, R; Likar, R

    2003-01-01

    Lornoxicam is a non opioid analgesic belonging to the oxicam group. The aim of this study was to determine whether lornoxicam has a preemptive analgesic effect. This study was carried out in a randomized, double-blind fashion with 66 patients divided into three groups undergoing gynecological operations. Group I was administered 8 mg of lornoxicam i.v. preoperatively followed by an 8-mg bolus every 8 h for a total dose of 24 mg in the first 24 h. Group II was administered 8 mg of lornoxicam i.v. bolus before the end of the operation followed by 8 mg every 8 h for a total dose of 24 mg in the first 24 h. Group III was administered placebo before and after the operation and for the first 24 h. The effectiveness was assessed postoperatively using the visual analogue scale (at rest, on exertion) and by calculating the total analgesic consumption of morphine hydrochloride in the first 24 h following operation. Vital signs and side effects were documented. Groups I and II demonstrated significantly reduced pain scores compared to group III at various points in time. Group I also demonstrated a weakly significant reduction in analgesic consumption of morphine hydrochloride postoperatively compared to groups II and III. Lornoxicam administered preemptively appears to improve the quality of postoperative analgesia and lead to reduced consumption of opioid analgesics postoperatively in patients undergoing gynecological operations.

  4. Luteal Phase Support in the Intrauterine Insemination (IUI Cycles: A Randomized Double Blind, Placebo Controlled Study.

    Directory of Open Access Journals (Sweden)

    Batool Hossein Rashidi

    2014-12-01

    Full Text Available To evaluate the impact of luteal phase support with vaginal progesterone on pregnancy rates in the intrauterine insemination (IUI cycles, stimulated with clomiphene citrate and human menopausal gonadotropin (hMG, in sub fertile couples.This prospective, randomized, double blind study was performed in a tertiary infertility center from March 2011 to January 2012. It consisted of 253 sub fertile couples undergoing ovarian stimulation for IUI cycles. They underwent ovarian stimulation with clomiphene citrate (100 mg and hMG (75 IU in preparation for the IUI cycle. Study group (n = 127 received luteal phase support in the form of vaginal progesterone (400 mg twice a day, and control group (n = 126 received placebo. Clinical pregnancy and abortion rates were assessed and compared between the two groups.The clinical pregnancy rate was not significantly higher for supported cycles than that for the unsupported ones (15.75% vs. 12.69%, p = 0.3. The abortion rate in the patients with progesterone luteal support compared to placebo group was not statistically different (10% vs. 18.75%, p = 0.45.It seems that luteal phase support with vaginal progesterone was not enhanced the success of IUI cycles outcomes, when clomiphene citrate and hMG were used for ovulation stimulation.

  5. 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).

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

    NARCIS (Netherlands)

    Nourbakhsh, Mohammad Reza; Fearon, Frank J.

    2008-01-01

    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 Stat

  7. Terbutaline depot tablets in childhood asthma. A double-blind controlled study

    DEFF Research Database (Denmark)

    Foged, N; Høst, A; Ljungholm, K

    1985-01-01

    . The design of the study was double-blind, cross-over, with a randomized allocation of the drugs. Both drugs improved the lung function significantly. The children had significantly less coughing during the night when they took depot tablets than when they took ordinary tablets. The side effects were few...

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

    Science.gov (United States)

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

    2013-01-01

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

  9. 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.…

  10. 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.

  11. A 1-year multicenter randomized double-blind comparison of repaglinide and glyburide for the treatment of type 2 diabetes. Dutch and German Repaglinide Study Group

    NARCIS (Netherlands)

    Wolffenbuttel, B H; Landgraf, R

    1999-01-01

    OBJECTIVE: Repaglinide is a newly developed oral blood glucose-lowering agent that exerts its effect by stimulating insulin secretion. This multicenter study was designed to compare the efficacy and safety of this drug with glyburide in a 1-year randomized double-blind study of outpatients with type

  12. A double blind study on the efficacy of local application of hemocoagulase solution in wound healing.

    Science.gov (United States)

    Aslam, Sachin; Francis, P G; Rao, B H S; Ummar, M; Issac, J K; Nair, R B

    2013-05-01

    The present double blind study has been designed to evaluate the efficacy of local application of hemocoagulase solution as compared to a placebo in wound healing following dental extraction. A total of 20 patients who required dental extraction for orthodontic intervention were included. The hemocoagulase solution and a placebo were locally applied to the extraction sockets and the efficacy of the solution in terms of bleeding control, anti-inflammatory responses, its antiseptic properties and efficacy in wound healing were evaluated. The mean time required to achieve hemostasis was found to be 1.37 minutes in side A (test) and 2.33 minutes in side B (control) indicating that side A achieved faster hemostasis when compared to side B. At the 6th hour postoperatively, bleeding was not evident on either sides, and the amount of pain in side A was found to be less compared to side B. The number of RBCs, polymorphs, chronic inflammatory cells were not different in both the groups, whereas at 3rd postoperative day epithelial cells were greater in side A (test) compared to side B (control). Biopsy reports on the 12th postoperative day indicated that the number of fibroblasts, epithelial cells, collagen count was found to be greater in side A (test) compared to side B (control). The topical hemocoagulase solution may be advocated in the field of oral and maxillofacial surgery, as a hemostatic agent and promoter of wound healing. However, further studies, with large number of cases and different clinical situations should be considered to authenticate the efficacy of this hemocoagulase solution in the practice of oral and maxillofacial surgery. Wound healing plays an important role in the success of any surgical procedure, such as extractions, and the hemocoagulase system may act as a hemostatic agent and a promoter of wound healing.

  13. 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

  14. 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.

  15. 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…

  16. 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 emollient therapy is used. PMID:21258039

  17. A double-blind study of superficial radiotherapy in psoriatic nail dystrophy

    Energy Technology Data Exchange (ETDEWEB)

    Yu, R.C.H.; King, C.M. (Univ. Dept. of Dermatology, Royal Liverpool Hospital (United Kingdom))

    1992-01-01

    In a double-blind controlled study, superficial radiotherapy (SRT) was given to psoriatic fingernails as three fractionated doses of 150 cGy (90 kV, 5 mA, 1.00 mm aluminium filter). The treated nails demonstrated a significant fall in scoring on a clinical rating scale 10 and 15 weeks after therapy (mean scores = 4.4 and 4.6 respectively) when compared with a mean pre-treatment score of 5.5 at week 0 (p less than 0.0001 and p less than 0.05 respectively); the treated nails also showed significant clinical improvement when compared with the sham-treated nails at weeks 10 and 15 (p less than 0.05). Mean nail thickness in treated nails 15 weeks after therapy was significantly thinner (mean thickness = 0.75 mm) than that of sham-treated nails (0.88 mm, p = 0.005), but the difference was not significant at week 20. The rate of linear nail growth was unaffected. SRT appears to confer a definite albeit temporary benefit on psoriasis of the nails at this dosage. (au).

  18. 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).

  19. Lithium carbonate in affective disorders. IV. A double-blind study of prophylaxis in unipolar recurrent depression.

    Science.gov (United States)

    Fieve, R R; Dunner, D L; Kumbarachi, T; Stallone, F

    1975-12-01

    The prophylactic efficacy of lithium carbonate vs placebo was examined in a double-blind study in a carefully delineated group of 28 unipolar recurrent depressed patients followed up from three months to four years. Indexes of prophylactic efficacy revealed a statistically significant decrease in episode frequency, depth of global depression scores, and increased clinic attendance rate in the lithium carbonate group compared with the placebo group. Planned studies are now needed to determine which unipolar patients do best on a maintenance regimen of lithium carbonate alone, lithium carbonate plus tricyclic drugs, or tricyclic drugs alone.

  20. Mirtazapine in essential tremor: a double-blind, placebo-controlled pilot study.

    Science.gov (United States)

    Pahwa, Rajesh; Lyons, Kelly E

    2003-05-01

    We sought to determine whether mirtazapine is safe and well-tolerated as a treatment for essential tremor (ET). We studied mirtazapine in a randomized, double-blind, placebo-controlled, crossover study of 17 ET patients. Patients were started with 15 mg per day of either mirtazapine or placebo for 1 week and the dose was escalated weekly until the targeted dose of 45 mg per day was achieved. This dose was maintained for 2 weeks. Tremor was assessed at baseline and after 14 days of 45 mg of mirtazapine or placebo. There was a minimum washout period of 14 days between the two arms of the study. Tremor assessments included global improvement, Fahn Tolosa Marin Tremor Rating Scale, Beck Depression Inventory and the Parkinson's Disease Questionnaire-39. Patient global improvement ratings indicated that in the placebo condition 12 patients were unchanged and 1 patient was mildly improved. In the mirtazapine condition, 10 patients were unchanged, 2 were moderately improved and 1 was markedly improved. There was no significant improvement with mirtazapine or placebo compared to baseline as measured by the Tremor Rating Scale. Adverse effects were more common in the mirtazapine group and included drowsiness, confusion, dry mouth, weight gain, polyuria, itching, nausea, gait and balance problems, blurred vision, and bad taste. We conclude that the majority of the ET patients do not benefit from mirtazapine. Mirtazapine has significant adverse effects and should be used cautiously in ET patients.

  1. Efficacy of Electroconvulsive Therapy in Treatment Resistant Schizophreinia : A double-blind study.

    Science.gov (United States)

    Goswami, Utpal; Kumar, Unnati; Singh, Baljit

    2003-01-01

    ECT, though not favoured in the West for treating schizophrenia, is regularly practiced in India for this indication, particularly in poorly responding/treatment resistant cases.Therefore, its role in treatment-resistant schizophrenia is a subject of systematic investigation. To compare the effectiveness and safety of Electroconvulsive therapy (ECT) in a group of treatment-resistant schizophrenia patients with a control group. Eligible and consenting patients were randomly allocated to the ECT or Sham ECT groups. Both received antipsychotic drugs.Twenty-five patients completed the study (ECT, n= IS; Sham ECT, n= 10).The study was conducted in a double-blind manner. Clinical change was assessed weekly with BPRS, CGI and adverse event measures.ANOVA for repeated measures and other post-hoc comparisons were used for data analysis. ECT treated patients improved significantly over successive weeks (p< 0.002) after 6 ECTs, whereas the group receiving sham-ECT did not In both the groups, however, CGI scores did not change significantly, suggesting a dissociated response pattern. ECT was associated with greater relief among carers and lower rehospitalization. ECT augmentation may well have a significant impact on the clinical course of patients with treatment resistance schizophrenia. It is unclear, but possible, that these changes may be reinforced and maintained by maintenance ECTs. Replication of the present investigation and further studies on maintenance ECT would be rewarding.

  2. Randomized double-blind clinical trial comparing two anesthetic techniques for ultrasound-guided transvaginal follicular puncture

    Science.gov (United States)

    de Oliveira, Gilvandro Lins; Serralheiro, Fernando Cesar; Fonseca, Fernando Luiz Affonso; Ribeiro, Onésimo Duarte; Adami, Fernando; Christofolini, Denise Maria; Bianco, Bianca; Barbosa, Caio Parente

    2016-01-01

    ABSTRACT Objective: To compare the anesthetic techniques using propofol and fentanyl versus midazolam and remifentanil associated with a paracervical block with lidocaine in performing ultrasound-guided transvaginal oocyte aspiration. Methods: A randomized double-blind clinical trial (#RBR-8kqqxh) performed in 61 women submitted to assisted reproductive treatment. The patients were divided into two groups: anesthetic induction with 1mcg/kg of fentanyl associated with 1.5mg/kg of propofol (FP Group, n=32), in comparison with anesthetic induction using 0.075mg/kg of midazolam associated with 0.25mcg/kg/min of remifentanil, and paracervical block with 3mL of 2% lidocaine (MRPB Group, n=29). Main outcome measures: human reproduction outcomes, modified Aldrete-Kroulik index, hemodynamic parameters, and salivary cortisol. Results: The results revealed a higher number of embryos formed in the FP Group (p50=2 versus 1; p=0.025), gestation rate two times higher in the FP Group (44.4% versus 22.2%; p=0.127), less time to reach AK=10 in the MRPB Group (p50=10 versus 2; p<0.001), and lower mean of hemodynamic parameters in the MRPB Group (p<0.05). Conclusion: Anesthesia with fentanyl and propofol as well as with midazolam, remifentanil, and paracervical block offered satisfactory anesthetic conditions when performing assisted reproduction procedures, providing comfort for the patient and physician. PMID:27759816

  3. 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...

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

    Science.gov (United States)

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

    2013-08-01

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

  5. [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.

  6. Safety and effectiveness of autoinoculation therapy in cutaneous warts: A double - blind, randomized, placebo - controlled study

    Directory of Open Access Journals (Sweden)

    Niharika Ranjan Lal

    2014-01-01

    Full Text Available Background: In spite of the availability of multiple treatment options, viral warts are known for their persistence and recurrence, causing frustration to patients and treating physicians. Aims: To study the effectiveness and safety of autoinoculation as a treatment modality in cutaneous warts. Methods: A double-blind, placebo-controlled study was carried out. In the treatment group, full-thickness warty tissue was excised, minced and implanted in a small dermal pocket. In the control group, warty tissue was only excised and not implanted, though a dermal pocket was made. Patients were evaluated every four weeks with lesion counts. The procedure was repeated at 4 and 8 weeks. Response was assessed at each visit and at 12 weeks. Results: Forty-eight patients with cutaneous warts (male: female = 32:16 were randomized into autoinoculation and control groups. The number of warts at baseline was comparable in both groups (P = 0.293. Reduction in the number of warts was significantly more in the autoinoculation group (8.50 ± 13.88 than in the control group (10.04 ± 5.80 from 8 weeks onwards (P = 0.010. Complete resolution occurred only in the autoinoculation group, in 62.5% of cases. Adverse effects were seen in 11 patients, including infection of the donor site (5 cases, keloid formation (3 and hypopigmentation (3. Conclusion: Autoinoculation may be an effective therapeutic modality for cutaneous warts and two sessions may be required for optimum results.

  7. Evaluation of acupuncture in the treatment of Parkinson's disease: a double-blind pilot study.

    Science.gov (United States)

    Cristian, Adrian; Katz, Meredith; Cutrone, Eileen; Walker, Ruth H

    2005-09-01

    As many as 40% of patients with Parkinson's disease (PD) use some form of complementary medicine during the course of their illness, and many try acupuncture. One nonblinded study of the effects of acupuncture in PD suggested that it might be helpful for some aspects of PD. We performed a double-blind, randomized, pilot study comparing acupuncture to a control nonacupuncture procedure to determine the effects of acupuncture upon a variety of PD-associated symptoms. Fourteen patients with Stage II or III PD received acupuncture or a control nonacupuncture protocol. Before and after treatment, patients were evaluated using the Motor subscale of the Unified Parkinson's Disease Rating Scale (UPDRS), the Parkinson's Disease Questionnaire (PDQ-39), and the Geriatric Depression Scale. There were no statistically significant changes for the outcomes measured. In the patients who received acupuncture, nonsignificant trends toward improvement were noted in the Activities of Daily Living score of the PDQ-39, the PDQ-39 Summary Index(c) 2005 Movement Disorder Society.

  8. A double-blind study of SB-220453 (Tonerbasat) in the glyceryltrinitrate (GTN) model of migraine.

    Science.gov (United States)

    Tvedskov, J F; Iversen, H K; Olesen, J

    2004-10-01

    The need for experimental migraine models increases as therapeutic options widen. In the present study, we investigated SB-220453 for efficacy in the glyceryltrinitrate (GTN) human experimental migraine model. SB-220453 is a novel benzopyran compound, which in animal models inhibits neurogenic inflammation, blocks propagation of spreading depression and inhibits trigeminal nerve ganglion stimulation-induced carotid vasodilatation. We included 15 patients with migraine without aura in a randomized double-blind crossover study. SB-220453 40 mg or placebo was followed by a 20-min GTN infusion. Headache, scored 0-10, was registered for 12 h, and fulfillment of International Headache Society (IHS) criteria was recorded until 24 h. Four subjects had a hypotensive episode after SB-220453 plus GTN but none after GTN alone. The reaction was unexpected, since animal models and previous human studies had shown no vascular or sympaticolytic activity with SB-220453. The study was terminated prematurely due to this interaction. GTN was consistent in producing headache and migraine that resembled the patients' usual spontaneous migraine. Nine patients had GTN on both study days. Peak headache score showed a trend towards reduction after SB-220453 compared with placebo (median 4 vs. 7, P = 0.15). However, no reduction was seen in the number of subjects experiencing delayed headache (8 vs. 8), number of subjects reporting migraine (6 vs. 8), migraine attacks fulfilling IHS criteria 1.1 or 1.7 (6 vs. 7) or IHS 1.1 alone (4 vs. 5). SB-220453 had no significant pre-emptive anti-migraine activity compared with placebo in this human model of migraine. Interaction between SB-220453 and GTN was discovered. This is important for the future development of the compound and underlines the usefulness of experimental migraine models.

  9. Ethical Blind Spots in Leading for Learning: An Australian Study

    Science.gov (United States)

    Bezzina, Michael

    2013-01-01

    Purpose: This study aims to explore the dynamics by which exposure to a moral rationale is given expression in schools, and how this is perceived as impacting on teaching, leadership practice and student outcomes. Design/methodology/approach: A total of 11 Australian schools were part of a project in which they were supported in applying a…

  10. 5-Hydroxytryptophan (5-HTP) and a MAOI (nialamide) in the treatment of depressions. A double-blind controlled study.

    Science.gov (United States)

    Aliño, J J; Gutierrez, J L; Iglesias, M L

    1976-01-01

    Through a controlled double-blind study in 30 hospitalized patients affected with endogenous depression, the antidepressant action of the combination of nialamide+l-5-HTP has been evaluated and compared with a control group which only received nialamide (+ placebo). The patients treated with nialamide + l-5-HTP achieved a fuller recovery than those who were treated with nialamide alone. The treatment with nialamide + l-5-HTP proved to have a shorter delay of onset. Side effects showed no marked differences except for the orthostatic hypotension which was less apparent in those patients treated with nialamide + l-5-HTP.

  11. 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.

  12. 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.

  13. Clobazam versus diazepam--a double-blind study in anxiety neurosis.

    Science.gov (United States)

    Doongaji, D R; Sheth, A; Apte, J S; Lakdawala, P D; Khare, C B; Thatte, S S

    1978-07-01

    Clobazam, a new antianxiety compound, was compared in a double-blind study with diazepam in 40 neurotic outpatients. Twenty-three patients completed the trial under clobazam conditions while 17 patients completed the trial under diazepam conditions. The trial was conducted for a period of four weeks of active drug administration followed by a one-week period of placebo administration. Clobazam was administered in three divided doses of 30 to 40 mg/day, while diazepam was administered in three divided doses of 15 to 20 mg/day, following a fixed dosage schedule. No significant differences were noted between the two treatment conditions during the drug trial period. The patients on clobazam maintained greater improvement during the placebo trial period for the variables "somatic anxiety" and "nights of sleep disturbance." Simultaneous motor coordination tests (hand steadiness test) showed greater improvement on clobazam throughout the trial period in patients with an initial error score greater than 50 points. This difference was significant during the second week of the trial.

  14. Double-blind study of ivermectin and diethylcarbamazine in African onchocerciasis patients with ocular involvement.

    Science.gov (United States)

    Lariviere, M; Vingtain, P; Aziz, M; Beauvais, B; Weimann, D; Derouin, F; Ginoux, J; Schulz-Key, H; Gaxotte, P; Basset, D

    1985-07-27

    In a randomised double-blind study, ivermectin was compared with diethylcarbamazine (DEC) and placebo in the treatment of onchocerciasis in 30 male patients from Mali with moderate to heavy Onchocerca volvulus infections and ocular involvement. 10 patients received a single oral dose of ivermectin, 12 mg, 10 received DEC daily for eight days (total dose 1.3 g), and 10 received matching placebo. Patients were examined periodically for twelve months. Punctate keratitis disappeared in 6 of 7 ivermectin patients but increased in DEC patients. Numbers of O volvulus microfilariae (mf) in the anterior chamber decreased slowly and eventually disappeared in most ivermectin patients during the six months following treatment; anterior chamber mf disappeared more rapidly in some patients after DEC, but reappeared within six months of stopping treatment. Both ivermectin and DEC caused a prompt decrease in mean skin mf density; density then increased in both groups over the twelve month observation period, reaching 9% of pretreatment values in ivermectin patients and 45% in the DEC group. Analysis of adult O volvulus from nodules excised at three and twelve months post treatment showed no effect of either drug on viability; however, there was evidence of degeneration of intra-uterine developing mf in the ivermectin group. Side-effects were less frequent and less severe in ivermectin patients than in DEC patients. Ivermectin as a single oral dose appears to be a more effective microfilaricidal drug than DEC in onchocerciasis.

  15. 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.

  16. Assessment of tetanus immunity status by tetanus quick stick and anamnesis: a prospective double blind study.

    Science.gov (United States)

    Orsi, G B; Modini, C; Principe, M A; Di Muzio, M; Moriconi, A; Amato, M G; Calderale, S M

    2015-01-01

    In patients with wounds admitted to Emergency Departments (ED) acquiring tetanus vaccination history by interview is very unreliable. Protected patients may receive unnecessary prophylaxis and unprotected nothing. Aim of the study was to evaluate tetanus immunity status comparing the traditional anamnestic method with the Tetanus Quick Stick (TQS), a rapid immunochromatographic test. A double-blind prospective study was carried out in the ED of the 1,000 bed teaching hospital Umberto I in Rome. Adult patients (≥18) with wounds attending at the ED were randomly included. Tetanus immunity status was evaluated by healthcare workers (HCWs) comparing the TQS test with the anamnesis. TQS test was performed by a trained HCW and afterwards the anamnesis about tetanus immunity status was collected by another HCW unaware of the TQS result. Also cost analysis was carried out. Overall 400 patients (242 males and 158 females) were included, mean age was 46.7 ± 20.2 years (median 44 range 18 - 109), 304 (76.0%) were italians and 96 foreigners (24.0%). Overall, 209 (52.2%) resulted TQS +, and protective immunity level was associated to lower mean age (40.1 ± 16.8 vs 53.8 ± 21,1; ptreatment. Adopting TQS test in all patients would also be cost-effective saving € 1.95/patient. As tetanus immunity is inversely related to age, for treatment would have been avoided in 57.1% of patients, with a mean reduction per patient of € 7.50/patient with the TQS vs. € 12.69/patient without. The study showed that tetanus protective immunity prevalence among adult patients attending our ED is about 50% and is mainly influenced by class age. TQS use allowed to reduce drastically inappropriate tetanus vaccine and immunoglobulins booster treatment. Also TQS use reduced costs.

  17. Comparison of efficacy, safety and cost-effectiveness of rupatadine and olopatadine in patients of chronic spontaneous urticaria: A randomized, double-blind, comparative, parallel group trial

    Directory of Open Access Journals (Sweden)

    Ganesh N Dakhale

    2016-01-01

    Full Text Available Objective: To compare efficacy, safety and cost-effectiveness of rupatadine and olopatadine in patients of chronic spontaneous urticaria. Materials and Methods: A 6-week, single-centered, randomized, double blind, parallel group comparative clinical study was conducted on patients with chronic spontaneous urticaria. Following inclusion and exclusion criteria, 60 patients were recruited and were randomized to two treatment groups and received the respective drugs for 6 weeks. At follow-up, parameters assessed were mean total symptom score (MTSS calculated by adding the mean number of wheals (MNW and the mean pruritus score (MPS, number of wheals, size of wheal, scale for interference of wheals with sleep (SIWS. Results: Both the drugs significantly reduced the MTSS, number of wheals, size of wheal, scale for interference of wheals with sleep, but olopatadine was found to be superior. In olopatadine group, there was significantly higher reduction in MTSS (p = 0.01, Number of wheals (P < 0.05, Size of wheals (p < 0.05, Scale for intensity of erythema (p < 0.05 and change in eosinopils count (p = 0.015 than that of rupatadine. Incidence of adverse effects was found to be less in olopatadine group when compared with rupatadine group. Cost effectiveness ratio was less in olopatadine group as compared to rupatadine group throughout the treatment. Conclusions: Olopatadine is a better choice in chronic spontaneous urticaria in comparison to rupatadine due to its better efficacy, safety and cost effectiveness profile.

  18. Factitious urticaria (dermographism): treatment by cimetidine and chlorpheniramine in a randomized double-blind study.

    Science.gov (United States)

    Kaur, S; Greaves, M; Eftekhari, N

    1981-02-01

    The HI-antihistamine chlorpheniramine and the H2-antihistamine cimetidine, given alone and in combination, have been compared with placebo in twenty patients with factitious urticaria (dermographism), in a double-blind, randomized cross-over trial. Of these regimes, the combination was the only treatment which significantly reduced weal size, flare size and duration of weal, compared with placebo, although other treatments approached statistical significance. Continuation of the most effective of the four treatments in nineteen of the patients for a further 3 months without breaking the randomization code provided further evidence of the great effectivness of combined cimetidine and chlorpheniramine. No significant side effects were note.

  19. 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.

  20. Information seeking by blind and sight impaired citizens: an ecological study

    Directory of Open Access Journals (Sweden)

    2000-01-01

    Full Text Available The article reports a study which investigated information seeking by blind and sight impaired people, with particular emphasis on the role of the Internet. A literature review revealed a paucity of studies about the information-seeking behaviour of groups of people with disabilities, including blind and sight impaired people. The study focussed very specifically on both personal lives and broader social contexts. The techniques for collecting qualitative data included two focus groups involving 16 participants and 15 individual interviewees, from both city and country settings. The findings of the study address issues of information needs, information sources, the role of the Internet in meeting needs and the barriers to the use of the Internet. A major conclusion is that people who are blind and sight impaired deserve to be provided with a range of ways of meeting information needs, as are available for people with normal sight. Given the inexorable continuing impact of the information age, it is also concluded that ways must be found so that people with disabilities can participate equitably in the information economy.

  1. [Double-blind study of clobazam (Odipam) and diazepam in non-psychotic anxiety states].

    Science.gov (United States)

    Ostrogonac, S; Vuckovic, S

    1989-01-01

    Clobazam (Odipam) and Diazepam were investigated by the double blind study method in patients with nonpsychotic anxiety. It was found out that both drugs had equal anxiolytic and tranquilizing effect with the same adverse effects. Greater frequency of excellent marks concerning the final therapeutic effect of Odipam in respect to other marks pointed to its better clinical tolerance, so that this drug was recommended as daily tranquilizer.

  2. Small intestinal mucosal injury in the experimental blind loop syndrome. Light- and electron-microscopic and histochemical studies.

    Science.gov (United States)

    Toskes, P P; Giannella, R A; Jervis, H R; Rout, W R; Takeuchi, A

    1975-05-01

    Microscopic (light and electron) and histochemical abnormalities have been demonstrated in the jejunum of rats with the blind loop syndrome. Three groups of animals were studied: normal control animals, and animals with either self-filling (SF) or self-emptying (SE) blind loops. Vitamin B12 malabsorption and bacterial overgrowth occurred only in those animals with SF blind loops. Three jejunal segments were studied: the blind loop segment and the jejunal segments proximal and distal to the blind loop. In the animals with the blind loop syndrome, those with SF blind loops, the most striking findings occurred in the blind loop itself, with similar but less marked changes in the jejunum distal but not proximal to the blind loop segment. Hypertrophy of both crypts and villi was evident with focal abnormalities of villus architecture. Approximately 10 to 20% of the columnar cells in the upper half of the villi were swollen and vesiculated. By electron microscopy microvilli demonstrated a variety of degeneration changes and the glycocalyx and terminal web were disrupted. Mitochondria and endoplasmic reticulum (ER), both smooth and rough, were swollen. Concentric whorls of parallel membranes and long, curvilinear rough ER were present in the cytoplasm. Histochemically, there was loss of enzymatic activity in the epithelial brush border, mitochondria and ER. Inasmuch as bacterial invasion of the jejunal mucosa was not seen, the etiology of these changes is not known but may involve bacterial "toxins" or products of bacterial metabolism. These morphological observations demonstrate that both brush border and intracellular injury occur in the jejunal epithelial cell of rats with the experimental blind loop syndrome.

  3. [Efficacy and tolerance of alprazolam and bromazepam in flexible doses. Double-blind study in 119 ambulatory anxious patients].

    Science.gov (United States)

    Ropert, R; Bernes, J; Dachary, J M

    1987-01-01

    Double-blind study comparing efficacy and safety of alprazolam and bromazepam in 119 ambulatory anxious patients receiving flexible dosage. 119 ambulatory anxious patients (global score on the Hamilton anxiety rating scale between 18 and 35) have been included in this double-blind trial (duration 4 weeks) comparing alprazolam and bromazepam given at flexible dosage. The global score on the Hamilton anxiety rating scale improved by 57.8% and 55.3% for alprazolam and bromazepam respectively. The percentage of therapeutic success according to the psychiatrist and the patient were respectively 82.7% and 79.3% for alprazolam compared to 74.1% and 71.9% for bromazepam. Fewer side-effects were recorded in the alprazolam group (97) than in the bromazepam group (120) and global safety of alprazolam seemed superior (p = 0.07). At trial-end, mean dosage reached 1.70 mg/day for alprazolam and 10.35 mg for bromazepam, but no correlation was found between anxiety intensity and optimal daily dosage used; however, a correlation has been found between the improvement of the overall Hamilton rating scale score and the dosage given (p = 0.02). The overall results suggest that the efficacy/safety ratio is better for alprazolam.

  4. Visual disability and major causes of blindness in NSW: a study of people aged 50 and over attending the Royal Blind Society 1984 to 1989.

    Science.gov (United States)

    Chan, C W; Billson, F A

    1991-11-01

    Visual disability in individuals aged 50 years and over seeking services of the Royal Blind Society in the years 1984 to 1989, was studied with respect to changes in frequency of major causes together with age and sex of those affected. The results mirror statistics in the UK. Age-related macular degeneration (AMD) accounts for an increasing proportion of visual disability (34% in 1984 to 43% in 1989). Of particular interest was the frequency of disability attributed to cataract. While decreasing (24% in 1984 to 19% in 1989), cataract still represents a significant cause of potentially treatable disability. The authors conclude that there is a changing prevalence of visual disability caused mainly by an increase in AMD and a subgroup of patients attending for services who appear to have a potentially remediable disability. These conclusions affirm the need for close liaison between ophthalmological practitioners and agencies for the blind.

  5. Professional kinesiology practice for chronic low back pain: single-blind, randomised controlled pilot study.

    Science.gov (United States)

    Eardley, S; Brien, S; Little, P; Prescott, P; Lewith, G

    2013-01-01

    Chronic low back pain is a highly prevalent condition with no definitive treatment. Professional Kinesiology Practice (PKP) is a little known complementary medicine technique using non-standard muscle testing; no previous effectiveness studies have been performed. This is an exploratory, pragmatic single-blind, 3-arm randomised sham-controlled pilot study with waiting list control (WLC) in private practice UK (2007-2009). 70 participants scoring ≥4 on the Roland and Morris Disability Questionnaire (RMDQ) were randomised to real or sham PKP receiving 1 treatment weekly for 5 weeks or a WLC. WLC's were re-randomised to real or sham after 6 weeks. The main outcome was a change in RMDQ from baseline to end of 5 weeks of real or sham PKP. With an effect size of 0.7 real treatment was significantly different to sham (mean difference RMDQ score = -2.9, p = 0.04, 95% CI -5.8 to -0.1). Compared to WLC, real and sham groups had significant RMDQ improvements (real -9.0, p < 0.01, 95% CI -12.1 to -5.8; effect size 2.1; sham -6.1, p < 0.01, 95% CI -9.1 to -3.1; effect size 1.4). Practitioner empathy (CARE) and patient enablement (PEI) did not predict outcome; holistic health beliefs (CAMBI) did, though. The sham treatment appeared credible; patients did not guess treatment allocation. 3 patients reported minor adverse reactions. Real treatment was significantly different from sham demonstrating a moderate specific effect of PKP; both were better than WLC indicating a substantial non-specific and contextual treatment effect. A larger definitive study would be appropriate with nested qualitative work to help understand the mechanisms involved in PKP.

  6. Non-contact low-frequency ultrasound therapy compared with UK standard of care for venous leg ulcers: a single-centre, assessor-blinded, randomised controlled trial.

    Science.gov (United States)

    White, Judith; Ivins, Nicola; Wilkes, Antony; Carolan-Rees, Grace; Harding, Keith G

    2016-10-01

    'Hard-to-heal' wounds are those which fail to heal with standard therapy in an orderly and timely manner and may warrant the use of advanced treatments such as non-contact low-frequency ultrasound (NLFU) therapy. This evaluator-blinded, single-site, randomised controlled trial, compared NLFU in addition to UK standard of care [SOC: (NLFU + SOC)] three times a week, with SOC alone at least once a week. Patients with chronic venous leg ulcers were eligible to participate. All 36 randomised patients completed treatment (17 NLFU + SOC, 19 SOC), and baseline demographics were comparable between groups. NLFU + SOC patients showed a -47% (SD: 38%) change in wound area; SOC, -39% (38%) change; and difference, -7·4% [95% confidence intervals (CIs) -33·4-18·6; P = 0·565]. The median number of infections per patient was two in both arms of the study and change in quality of life (QoL) scores was not significant (P = 0·490). NLFU + SOC patients reported a substantial mean (SD) reduction in pain score of -14·4 (14·9) points, SOC patients' pain scores reduced by -5·3 (14·8); the difference was -9·1 (P = 0·078). Results demonstrated the importance of high-quality wound care. Outcome measures favoured NLFU + SOC over SOC, but the differences were not statistically significant. A larger sample size and longer follow-up may reveal NLFU-related improvements not identified in this study.

  7. A Double Blind Comparative Trial of Powdered Ginger Root, Hyosine Hydrobromide, and Cinnarizine in the Prophylaxis of Motion Sickness Induced by Cross Coupled Stimulation,

    Science.gov (United States)

    A double blind laboratory trial was conducted to study the relative effectiveness of powdered ginger root (1G), hyosine (0.6 mg), cinnarizine (15 mg...report that powdered root ginger is of value in the prophylaxis of motion sickness. Significant differences in the results of performance tests were

  8. Biofuel: a comparative case study

    OpenAIRE

    Siddiqui, Aamir; Kading, Christopher; Carter, Kasey

    2013-01-01

    Approved for public release; distribution is unlimited This project analyzes the governments role in the commercialization of biofuel by comparing biofuel commercialization efforts to those of nuclear power and nanotechnology commercialization. The PESTEL framework is applied to nuclear power and nanotechnology to identify key factors relevant to successful commercialization. These success factors are compared to current government biofuel policies to infer the likelihood of successful bio...

  9. 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

  10. [Double-blind study of the treatment of disc lumbosciatica by chemonucleolysis].

    Science.gov (United States)

    Feldman, J; Menkès, C J; Pallardy, G; Chevrot, A; Horreard, P; Zenny, J C; Godefroy, D; Amor, B

    1986-03-01

    A randomized, double-blind study was made of 39 patients with discolumbar hernias that were unresponsive to medical treatment. They were treated either by nucleolysis with chymopapain (4 000 U of discase), or by discography followed by injection of distilled water as a placebo. After one month, treatment was found to be successful in 55% of cases undergoing nucleolysis and in 26% of cases receiving the placebo. The results after 3 months were 65% and 42%. respectively. After one month, the intensity of lumbar pain decreased by 44% on average in the group treated by chymopapain, and by 0% in the placebo group. Radicular pain decreased by 53% in the first group and by 26% in the placebo group, and improvement in Lasègue's sign was 51% and 20%, respectively. Analgesic treatment was reduced in patients treated by chymopapain: 65% of patients in the first group report some or much improvement in their sciatica, whereas this figure was 26% in the placebo group (p less than 0.02). Contralateral sciatica was observed in 3 patients of the placebo group. The average give in the disc one month after nucleolysis was 34% in the chymopapain group and 27% in the placebo group, without correlation with the clinical result. On average, patients were monitored for one year after nucleolysis, and during this year 6 patients from the chymopapain group were operated upon, compared with 10 patients from the placebo group. Although these results are at the limit of statistical significance because of the number of patients studied, they confirm the innocuousness and effectiveness of chymopapain in the treatment of discolumbar hernias.

  11. Oral iloprost as a treatment for Raynaud's syndrome: a double blind multicentre placebo controlled study.

    Science.gov (United States)

    Belch, J J; Capell, H A; Cooke, E D; Kirby, J D; Lau, C S; Madhok, R; Murphy, E; Steinberg, M

    1995-01-01

    OBJECTIVE--To compare the efficacy, tolerance and safety of 50-150 micrograms orally administered iloprost given twice a day versus placebo in patients with Raynaud's syndrome. METHODS--The study was multicentre (n = 3), double blind and placebo controlled. Sixty three patients who had eight or more vasospastic attacks per week were enrolled. After a one week run-in period, all patients received either iloprost or placebo treatment to a maximum tolerated dose of 150 micrograms twice a day for 10 days. Diary cards assessed the duration and severity of the vasospastic attacks. Side effects were monitored by direct questioning. A global assessment of treatment efficacy was made by the patient at the end of treatment and two weeks later. RESULTS--Patient opinion tended to favour iloprost at the end of the 10 day treatment phase (p = 0.09) and this was significant at day 24 (the follow up visit) (p = 0.011). Although the duration and severity of attacks tended to decrease in the iloprost treated group, these results tended not to reach statistical significance (for severity p = 0.06 at end of treatment, p = 0.09 on day 24). CONCLUSION--Iloprost administered intravenously has been shown to be of benefit in the treatment of the Raynaud's syndrome associated with systemic sclerosis, but this route of administration is inconvenient. This study evaluated the use of iloprost administered orally to patients with Raynaud's syndrome. Patient documented improvement was significantly improved by iloprost. Diary card analysis showed a trend in favour of iloprost, but these results did not reach statistical significance. PMID:7538285

  12. A comparative assessment of two different debris flow propagation approaches – blind simulations on a real debris flow event

    Directory of Open Access Journals (Sweden)

    L. M. Stancanelli

    2014-11-01

    Full Text Available A detailed comparison between the performances of two different approaches to debris flow modelling has been carried out. In particular, the results of a mono-phase Bingham model (FLO-2D and these of a two phase model (TRENT-2D obtained from a blind test have been compared. As a benchmark test the catastrophic event of 1 October 2009 which struck Sicily causing several fatalities and damages has been chosen. The predicted temporal evolution of several parameters of the debris flow (as the flow depths and the propagation velocities has been analyzed in order to investigate the advantages and disadvantages of the two models in reproducing the global dynamics of the event. Analysis between the models results with survey data have been carried out, not only for the determination of statistical indicators of prediction accuracy, but also for the application of the Receiver Operator Characteristic (ROC approach. Provided that the proper rheological parameters and boundary conditions are assigned, both models seem capable of reproducing the inundation areas in a fairly good way. However, the main differences in the application rely in the choice of such rheological parameters. Indeed, within the more user friendly FLO-2D model the tuning of the parameters must be done empirically, with no evidence of the physics of the phenomena. On the other hand, for the TRENT-2D the parameters are physically based and can be estimated from the properties of the solid material, thus reproducing more reliable results. A second important difference between the two models is that in the first method the debris flow is treated as homogeneous flow, in which the total mass is kept constant from initiation in the upper part of the basin up to the deposition on debris fan. On the contrary, the second approach is suite to reproduce the erosion and deposition processes and the displaced mass can be directly related to the rainfall event. Application of both models in an highly

  13. Randomized double-blind clinical trial comparing two anesthetic techniques for ultrasound-guided transvaginal follicular puncture.

    Science.gov (United States)

    Oliveira, Gilvandro Lins de; Serralheiro, Fernando Cesar; Fonseca, Fernando Luiz Affonso; Ribeiro, Onésimo Duarte; Adami, Fernando; Christofolini, Denise Maria; Bianco, Bianca; Barbosa, Caio Parente

    2016-01-01

    To compare the anesthetic techniques using propofol and fentanyl versus midazolam and remifentanil associated with a paracervical block with lidocaine in performing ultrasound-guided transvaginal oocyte aspiration. A randomized double-blind clinical trial (#RBR-8kqqxh) performed in 61 women submitted to assisted reproductive treatment. The patients were divided into two groups: anesthetic induction with 1mcg/kg of fentanyl associated with 1.5mg/kg of propofol (FP Group, n=32), in comparison with anesthetic induction using 0.075mg/kg of midazolam associated with 0.25mcg/kg/min of remifentanil, and paracervical block with 3mL of 2% lidocaine (MRPB Group, n=29). Main outcome measures: human reproduction outcomes, modified Aldrete-Kroulik index, hemodynamic parameters, and salivary cortisol. The results revealed a higher number of embryos formed in the FP Group (p50=2 versus 1; p=0.025), gestation rate two times higher in the FP Group (44.4% versus 22.2%; p=0.127), less time to reach AK=10 in the MRPB Group (p50=10 versus 2; panestesia com 1mcg/kg de fentanil associada com 1,5mg/kg de propofol (Grupo FP, n=32), em comparação com ao grupo submetido à indução da anestesia utilizando 0,075mg/kg de midazolam associada com 0,25mcg/kg/min de remifentanil, e bloqueio paracervical com 3mL de lidocaína a 2% (Grupo MRBP, n=29). Foram avaliados os resultados reprodutivos, índice modificado de Aldrete e Kroulik, parâmetros hemodinâmicos e cortisol salivar. Foi encontrado um número mais elevado de embriões formados no Grupo FP (p50=2 versus 1; p=0,025), taxa de gestação duas vezes mais elevada no Grupo FP (44,4% versus 22,2%; p=0,127), menos tempo para alcançar AK=10 no Grupo MRBP (p50=10 versus 2; panestesias (com fentanil e propofol, e com midazolam, remifentanil e bloqueio paracervical) ofereceram condições anestésicas satisfatórias na realização de procedimentos realizados em reprodução assistida, proporcionando conforto para o paciente e médico.

  14. A comparative assessment of two different debris flow propagation approaches - blind simulations on a real debris flow event

    Science.gov (United States)

    Stancanelli, L. M.; Foti, E.

    2015-04-01

    A detailed comparison between the performances of two different approaches to debris flow modelling was carried out. In particular, the results of a mono-phase Bingham model (FLO-2D) and that of a two-phase model (TRENT-2D) obtained from a blind test were compared. As a benchmark test the catastrophic event of 1 October 2009 which struck Sicily causing several fatalities and damage was chosen. The predicted temporal evolution of several parameters of the debris flow (such as flow depth and propagation velocity) was analysed in order to investigate the advantages and disadvantages of the two models in reproducing the global dynamics of the event. An analysis between the models' results with survey data have been carried out, not only for the determination of statistical indicators of prediction accuracy, but also for the application of the Receiver Operator Characteristic (ROC) approach. Provided that the proper rheological parameters and boundary conditions are assigned, both models seem capable of reproducing the inundation areas in a reasonably accurate way. However, the main differences in the application rely on the choice of such rheological parameters. Indeed, within the more user-friendly FLO-2D model the tuning of the parameters must be done empirically, with no evidence of the physics of the phenomena. On the other hand, for the TRENT-2D the parameters are physically based and can be estimated from the properties of the solid material, thus reproducing more reliable results. A second important difference between the two models is that in the first method the debris flow is treated as a homogeneous flow, in which the total mass is kept constant from its initiation in the upper part of the basin to the deposition in a debris fan. In contrast, the second approach is suited to reproduce the erosion and deposition processes and the displaced mass can be directly related to the rainfall event. Application of both models in a highly urbanized area reveals the

  15. Status of drugs-of-abuse testing in urine under blind conditions: an AACC study.

    Science.gov (United States)

    Frings, C S; Battaglia, D J; White, R M

    1989-05-01

    We report results of a blind study designed to determine the accuracy of drugs-of-abuse testing in urine as done in 31 laboratories across the United States. The drugs studied were amphetamines, cannabinoids, cocaine, opiates, and phencyclidine. These laboratories confirmed all positive drug results with a different analytical method. Ten urine samples were sent to each laboratory, which resulted in 1486 trials. There were no false-positive results. The overall accuracy rate was 97%. Our study demonstrates that urine drug testing can be accurate when performed by qualified staff, using up-to-date screening and confirmation methods, appropriate quality-assurance measures, and a chain of custody.

  16. The utility of EMG interference pattern analysis in botulinum toxin treatment of torticollis: a randomised, controlled and blinded study

    DEFF Research Database (Denmark)

    Werdelin, L; Dalager, T; Fuglsang-Frederiksen, Anders

    2011-01-01

    . METHODS: Twenty-six patients with torticollis were included and treated for 1year in this prospective, blinded study. Quantitative EMG was performed simultaneously in the four most frequently affected muscles: the sternocleidomastoid muscles and the posterior neck muscles on both sides. EMGs were analysed...... for turns per second. Clinical ratings were performed by an experienced neurologist (A). Injections were given by another neurologist (B), who was blinded to the ratings. In group 1, the results of the EMG were available to the treating neurologist B, whereas in group 2, neurologist B was blinded. In group...... precise injection and may reduce side effects and the risk of development of antibodies to BT....

  17. The Blind as "Ordinary People".

    Science.gov (United States)

    Feinman, Saul

    1978-01-01

    Based on a paper presented at the 1977 Western Social Science Association Meeting in Denver, Colorado, the article reports on a study that compared major demographic features of a sample of 70 legally blind adults with the sighted adult sample studied in the 1975 National Opinion Research Center General Social Survey. (Author/DLS)

  18. Comparative evaluation of dexmedetomidine and midazolam-ketamine combination as sedative agents in pediatric dentistry: A double-blinded randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Parul Uppal Malhotra

    2016-01-01

    Full Text Available Background: Pharmacological methods have been used as an adjunct to enhance child cooperativeness and facilitate dental treatment. Objective: Purpose of this study was to evaluate and compare the effect of sedation by intranasal dexmedetomidine and oral combination drug midazolam–ketamine in a group of children with uncooperative behavior requiring dental treatment. Materials and Methods: This was a prospective, randomized, double-blind study that included patients 3–9 years old with American Society of Anesthesiologists-I status. About 36 children presenting early childhood caries were randomly assigned to one of three groups studied: Group MK received intranasal saline and oral midazolam (0.5 mg/kg with ketamine (5 mg/kg mixed in mango juice; Group DX received intranasal dexmedetomidine (1 μg/kg and oral mango juice; and Group C received intranasal saline and oral mango juice. Patients' heart rate, blood pressure, and oxygen saturation were recorded before, during, and at the end of the procedure. Patients' behavior, sedation status, and wake up behavior were evaluated with modified observer assessment of alertness and sedation scale. Ease of treatment completion was evaluated according to Houpt scale. Results: Hemodynamic changes were statistically insignificant in Group MK and Group DX. About 75% patients in Group MK were successfully sedated as compared to 53.9% Group DX and none of the patients in Group C. Ease of treatment completion was better with Group MK as compared to Group DX and least with Group C. Around 50% patients in Group MK had postoperative complications. Conclusion: Oral midazolam–ketamine combination and intranasal dexmedetomidine evaluated in the present study can be used safely and effectively in uncooperative pediatric dental patients for producing conscious sedation.

  19. Pharmacodynamic differences between canagliflozin and dapagliflozin: results of a randomized, double-blind, crossover study.

    Science.gov (United States)

    Sha, S; Polidori, D; Farrell, K; Ghosh, A; Natarajan, J; Vaccaro, N; Pinheiro, J; Rothenberg, P; Plum-Mörschel, L

    2015-02-01

    To compare the pharmacodynamic effects of the highest approved doses of the sodium glucose co-transporter 2 (SGLT2) inhibitors canagliflozin and dapagliflozin on urinary glucose excretion (UGE), renal threshold for glucose excretion (RTG ) and postprandial plasma glucose (PPG) excursion in healthy participants in a randomized, double-blind, two-period crossover study. In each treatment period, participants (n = 54) received canagliflozin 300 mg or dapagliflozin 10 mg for 4 days (20 min before breakfast). A mixed-meal tolerance test (600 kcal; 75 g glucose) was performed at baseline and on day 4 of each treatment period to assess changes in incremental PPG (PPGΔAUC0-2 h ). We measured 24-h UGE and plasma glucose on day 4 to determine 24-h mean RTG . Canagliflozin 300 mg and dapagliflozin 10 mg had similar effects on UGE and RTG for 4 h after dosing, but canagliflozin was associated with higher UGE and greater RTG reductions for the remainder of the day. Mean 24-h UGE was ∼25% higher with canagliflozin than with dapagliflozin (51.4 vs. 40.8 g), and 24-h mean RTG was ∼0.4 mmol/l (7 mg/dl) lower with canagliflozin than with dapagliflozin (3.79 vs. 4.17 mmol/l; p canagliflozin delayed and reduced PPG excursion (between-treatment difference in PPGΔAUC0-2 h from baseline expressed as a percentage of baseline mean, -10.2%; p = 0.0122). Canagliflozin and dapagliflozin were generally well tolerated. In healthy participants, canagliflozin 300 mg provided greater 24-h UGE, a lower RTG and smaller PPG excursions than dapagliflozin 10 mg. © 2014 The Authors. Diabetes, Obesity and Metabolism published by JohnWiley & Sons Ltd.

  20. A randomised, double-blind trial comparing ceftobiprole medocaril with ceftriaxone with or without linezolid for the treatment of patients with community-acquired pneumonia requiring hospitalisation.

    Science.gov (United States)

    Nicholson, Susan C; Welte, Tobias; File, Thomas M; Strauss, Richard S; Michiels, Bart; Kaul, Pratibha; Balis, Dainius; Arbit, Deborah; Amsler, Karen; Noel, Gary J

    2012-03-01

    Community-acquired pneumonia (CAP) is a serious infection requiring hospitalisation in 20% of cases. The novel cephalosporin ceftobiprole has microbiological activity against the major bacterial pathogens causing CAP, including Streptococcus pneumoniae, Haemophilus influenzae and Klebsiella pneumoniae, as well as against Staphylococcus aureus, including meticillin-resistant S. aureus (MRSA). This was a multicentre, double-blind study in which 706 patients with CAP severe enough to require hospitalisation were randomised to ceftobiprole or to an expert-recommended course of ceftriaxone ± linezolid (comparator group). Clinical and microbiological outcomes were determined 7-14 days after completion of therapy (test-of-cure visit). For the 469 clinically evaluable patients, cure rates were 86.6% vs. 87.4% for ceftobiprole and comparator, respectively [95% confidence interval (CI) of the difference, -6.9% to 5.3%]; in the intention-to-treat (ITT) analysis of 638 CAP patients, these cure rates were 76.4% vs. 79.3%, respectively (95% CI of the difference, -9.3% to 3.6%). A typical bacterial pathogen was identified in 29% of the ITT population. Microbiological eradication rates in the 144 microbiologically evaluable patients were 88.2% and 90.8% for the respective treatment groups (95% CI of the difference, -12.6% to 7.5%). Both study drugs were well tolerated, with but a minority of patients requiring premature discontinuation due to an adverse event (6% in the ceftobiprole group and 4% in the comparator group). The overall incidence of treatment-related adverse events was higher in the ceftobiprole group, primarily owing to differences in rates of self-limited nausea (7% vs. 2%) and vomiting (5% vs. 2%). In summary, ceftobiprole was non-inferior to the comparator (ceftriaxone ± linezolid) in all clinical and microbiological analyses conducted, suggesting that ceftobiprole has a potential role in treating hospitalised patients with CAP. [ClinicalTrials.gov identifier

  1. 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

  2. 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.

  3. A low dose of droperidol decreases the desflurane concentration needed during breast cancer surgery: a randomized double-blinded study

    Science.gov (United States)

    Adachi, Yushi U; Makita, Koshi

    2017-01-01

    Background Droperidol (DHB) reportedly reduces the dose of propofol needed to achieve hypnosis when anesthesia is induced and decreases the bispectral index (BIS) in propofol-sedated patients during spinal anesthesia. We reported previously that supplemental DHB decreased the BIS after the administration of sevoflurane and remifentanil. This study investigated the effect of DHB on desflurane (DES) consumption in a clinical setting. Methods We conducted a prospective, randomized double-blinded study of 35 women with American Society of Anesthesiologist physical status I or II who underwent a mastectomy. Either DHB (20 µg/kg) or a saline placebo was administered to patients 30 min after the induction of anesthesia. A blinded anesthesiologist maintained a BIS value of 50 during anesthesia by modulating inhaled DES concentrations that changed 0.5% at 2.5 min intervals and maintained analgesia via the constant administration of remifentanil by referring to vital signs. The primary endpoint was the effect of DHB on DES consumption. The secondary endpoints included blood circulatory parameters, the time from the end of surgery to extubation, and discharge time between the groups. Results The characteristics of the patients did not differ between the groups. The DHB group used a mean of 27.2 ± 6.0 ml of DES compared with 41.4 ± 9.5 ml by the placebo group (P effects.

  4. 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.

  5. Facilitation of fiberoptic nasotracheal intubation with magnesium sulfate: A double-blind randomized study

    Science.gov (United States)

    Elgebaly, Ahmed Said; Eldabaa, Ahmed Ali

    2014-01-01

    Background: A double-blinded, prospective, and randomized study was designed to determine the efficacy and tolerability of intravenous (IV) magnesium sulfate (MgSO4) to facilitate fiberoptic bronchoscopic (FOB) nasotracheal intubations. Patients and Methods: A total of 120 patients scheduled to undergo elective awake fiberoptic nasotracheal intubation, while they were anesthetized for elective surgery were randomly allocated to one of three groups: The control Group S (n = 40) received 100 ml (50 ml 0.9% saline + 50 ml paracetamol) was infused in 10 min and direct IV 5 ml 0.9% normal saline, Group MD (n = 40): Received midazolam IV in a dose of 0.07 mg/kg in 5 ml 0.9% normal saline and 100 ml 0.9% was infused in 10 min and Group MS (n = 40): IV 45 mg/kg MgSO4 10 min in 100 ml of 0.9% normal saline through 10 min and direct IV 5 ml 0.9% normal saline. Results: Time required for nasotracheal intubation was significantly less in group Groups MD and MS, as compared with the control group, but not significant between the two groups. (Group MD: 9.05 + 1.95 min, Group MS 3.75 + 0.75 min and Group S 16.85 + 1.7 min). However, the number of fiberoptic intubation was significantly more in the MD and MS groups, as compared with the control group. Easy intubation (control group: 0, Group MD: 25 and Group MS: 35), moderate difficulty (control group: 5, Group MD: 12 and Group MS: 4) and difficult (control group: 35, Group MD: 3 and Group MS: 1). Procedure adverse events were significantly lower in Group MS. None of the patients in Group MS had procedure hypoxia, but it occurred in 10 patients of Group MD and 20 patients in Group S. Six patients in Group S and two in Group MD had procedure apnea whereas, none of the patients in the MS group experienced this. After medication and just before intubation heart rate and mean arterial pressure were significantly less in Groups MD and MS, as compared to the control group (Group MD: 77 + 7.7 beat/min, Group MS: 70 + 5.6 beat/min and

  6. Buspirone versus methylphenidate in the treatment of children with attention- deficit/ hyperactivity disorder: randomized double-blind study.

    Science.gov (United States)

    Mohammadi, Mohammad-Reza; Hafezi, Poopak; Galeiha, Ali; Hajiaghaee, Reza; Akhondzadeh, Shahin

    2012-01-01

    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 buspirone was

  7. 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

  8. Benchmarked Library Websites Comparative Study

    KAUST Repository

    Ramli, Rindra M.

    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.

  9. Willed blindness

    DEFF Research Database (Denmark)

    Gjerris, Mickey

    2015-01-01

    This article describes how we seem to live in a willed blindness towards the effects that our meat production and consumption have on animals, the environment and the climate. A willed blindness that cannot be explained by either lack of knowledge or scientific uncertainty. The blindness enables us...... blindness focusing on the development of either a new moral vision of our obligations or new visions of what a good life is....

  10. "Live high-train low" using normobaric hypoxia: a double-blinded, placebo-controlled study

    DEFF Research Database (Denmark)

    Siebenmann, Christoph; Robach, Paul; Jacobs, Robert A

    2012-01-01

    The combination of living at altitude and training near sea level [live high-train low (LHTL)] may improve performance of endurance athletes. However, to date, no study can rule out a potential placebo effect as at least part of the explanation, especially for performance measures. With the use...... of a placebo-controlled, double-blinded design, we tested the hypothesis that LHTL-related improvements in endurance performance are mediated through physiological mechanisms and not through a placebo effect. Sixteen endurance cyclists trained for 8 wk at low altitude (...

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

    OpenAIRE

    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. De...

  12. Color Blindness

    Institute of Scientific and Technical Information of China (English)

    严双红

    2007-01-01

    About one in 12 boys is color-blind, and one in every 400 girls, so in each school class there are likely to be at least one or two people who are color-blind. Because they are color- blind from birth, most people do not know that they are color-

  13. 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

    AFRL-SA-WP-SR-2017-0003 Ketamine Patient-Controlled Analgesia for Acute Pain in Trauma Patients: A Randomized, Active Comparator...June 2013 – December 2016 4. TITLE AND SUBTITLE Ketamine Patient-Controlled Analgesia for Acute Pain in Trauma Patients: A Randomized, Active...in trauma patients while reducing opioid consumption in the traumatically injured patient. The objective of this study was to compare differences in

  14. Catheter-based donor site analgesia after rib grafting: a prospective, randomized, double-blinded clinical trial comparing ropivacaine and bupivacaine.

    Science.gov (United States)

    Anantanarayanan, Parameswaran; Raja, Dharmesh Kumar; Kumar, J Naveen; Sneha, P; Christabel, Amelia; Manikandhan, Ramanathan; Elavazhagan, Namasivayam

    2013-01-01

    Although ribs provide the best source of cartilage for reconstruction, its harvesting is associated with significant postoperative pain and sometimes incapacitating functional deficit. The lack of studies in the maxillofacial literature on regional analgesia for rib harvests stimulated this study design. This study compared ropivacaine with bupivacaine in providing postoperative analgesia after rib harvest. Patients who needed rib grafting for maxillofacial reconstructive procedures were enrolled in this prospective, randomized, double-blinded clinical trial. Patients were randomly allocated to 1 of 2 groups with different modalities of anesthesia against a control group. A catheter was embedded in the rib donor site in all patients. Patients in group A received 0.75% ropivacaine, those in group B received 0.5% bupivacaine, and those in croup C patients received normal saline and served as the controls. The outcome variables were the subjective and objective pain scores, the duration of action, and the efficacy of the drugs after rib harvest. Dependent variables were the need for a rescue analgesic by the patient and the duration of hospital stay. The subjective intensity of pain at rest was calculated using the visual analog scale. The objective pain scores at function were evaluated by comparing preoperative with postoperative values of incentive spirometry, breath-holding test, maximal chest expansion, and match-blowing test. The t test and paired samples test were used to the analyze data, and a P value less than .05 was considered significant. Forty-two patients were enrolled in this study. Patients in groups A and B showed significant pain relief compared with group C. Patients in group A showed significantly less pain at rest (2.8±0.894) compared with those in group B (3.7±0.875; Ppain at function (3.8±0.894) compared with those in group B (4.7±0.923; Prib harvesting provides excellent postoperative comfort, with ropivacaine providing an earlier return

  15. A randomized, double-blind trial comparing the effects of amlodipine besylate/benazepril HCl vs amlodipine on endothelial function and blood pressure.

    Science.gov (United States)

    Mohler, Emile R; Herrington, David; Ouyang, Pamela; Mangano, Charles; Ritter, Susan; Davis, Pamela; Purkayastha, Das; Gatlin, Marjorie; Vogel, Robert A

    2006-10-01

    Evidence suggests that renin-angiotensin-aldosterone system inhibition ameliorates endothelial dysfunction. The authors examined the effect of amlodipine besylate/benazepril HCl combination treatment compared with amlodipine besylate monotherapy in modulating endothelial dysfunction. This multicenter, double-blind, 12-week study randomized 70 hypertensive subjects with at least one other endothelial dysfunction risk factor to amlodipine besylate/benazepril HCl (5/20 mg/d force-titrated to 5/40 mg/d) or amlodipine besylate monotherapy (5 mg/d force-titrated to 10 mg/d). Both the combination and monotherapy produced significant median increases from baseline in percentage flow-mediated vasodilation (2.0% and 1.2%, respectively) and percentage change in percent flow-mediated vasodilation (25% and 16%, respectively). These improvements were numerically larger with combination treatment, but between-group differences did not achieve statistical significance. Reductions in systolic and diastolic blood pressure were significantly greater (P=.0452/P=.0297) with combination treatment (-18.6/-12.3 mm Hg) than with monotherapy (-14.8/-9.1 mm Hg). A highly positive correlation between change in systolic blood pressure and change in percent of flow-mediated vasodilation was demonstrated only for combination treatment.

  16. Blinded double reading yields a higher programme sensitivity than non-blinded double reading at digital screening mammography: a prospected population based study in the south of The Netherlands.

    Science.gov (United States)

    Klompenhouwer, Elisabeth G; Voogd, Adri C; den Heeten, Gerard J; Strobbe, Luc J A; de Haan, Anton F J; Wauters, Carla A; Broeders, Mireille J M; Duijm, Lucien E M

    2015-02-01

    To prospectively determine the screening mammography outcome at blinded and non-blinded double reading in a biennial population based screening programme in the south of the Netherlands. We included a consecutive series of 87,487 digital screening mammograms, obtained between July 2009 and July 2011. Screening mammograms were double read in either a blinded (2nd reader was not informed about the 1st reader's decision) or non-blinded fashion (2nd reader was informed about the 1st reader's decision). This reading strategy was alternated on a monthly basis. Women with discrepant readings between the two radiologists were always referred for further analysis. During 2 years follow-up, we collected the radiology reports, surgical correspondence and pathology reports of all referred women and interval breast cancers. Respectively 44,491 and 42,996 screens had been read either in a blinded or non-blinded fashion. Referral rate (3.3% versus 2.8%, preading whereas the cancer detection rate per 1000 screens (7.4 versus 6.5, p=0.14) and positive predictive value of referral (22% versus 23%, p=0.51) were comparable. Blinded double reading resulted in a significantly higher programme sensitivity (83% versus 76%, p=0.01). Per 1000 screened women, blinded double reading would yield 0.9 more screen detected cancers and 0.6 less interval cancers than non-blinded double reading, at the expense of 4.4 more recalls. We advocate the use of blinded double reading in order to achieve a better programme sensitivity, at the expense of an increased referral rate and false positive referral rate. Copyright © 2014 Elsevier Ltd. All rights reserved.

  17. 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

    2016-01-01

    Objective 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. Setting A Menstrual Disorder Centre at a public hospital in Shanghai, China. Participants 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. Interventions 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. Primary and secondary outcome measures 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. Results 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. Conclusions Acupuncture point injection of

  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...

  19. Acute Effects of Caffeine on Heart Rate Variability, Blood Pressure and Tidal Volume in Paraplegic and Tetraplegic Compared to Able-Bodied Individuals: A Randomized, Blinded Trial

    Science.gov (United States)

    Flueck, Joelle Leonie; Schaufelberger, Fabienne; Lienert, Martina; Schäfer Olstad, Daniela; Wilhelm, Matthias; Perret, Claudio

    2016-01-01

    Caffeine increases sympathetic nerve activity in healthy individuals. Such modulation of nervous system activity can be tracked by assessing the heart rate variability. This study aimed to investigate the influence of caffeine on time- and frequency-domain heart rate variability parameters, blood pressure and tidal volume in paraplegic and tetraplegic compared to able-bodied participants. Heart rate variability was measured in supine and sitting position pre and post ingestion of either placebo or 6 mg caffeine in 12 able-bodied, 9 paraplegic and 7 tetraplegic participants in a placebo-controlled, randomized and double-blind study design. Metronomic breathing was applied (0.25 Hz) and tidal volume was recorded during heart rate variability assessment. Blood pressure, plasma caffeine and epinephrine concentrations were analyzed pre and post ingestion. Most parameters of heart rate variability did not significantly change post caffeine ingestion compared to placebo. Tidal volume significantly increased post caffeine ingestion in able-bodied (p = 0.021) and paraplegic (p = 0.036) but not in tetraplegic participants (p = 0.34). Systolic and diastolic blood pressure increased significantly post caffeine in able-bodied (systolic: p = 0.003; diastolic: p = 0.021) and tetraplegic (systolic: p = 0.043; diastolic: p = 0.042) but not in paraplegic participants (systolic: p = 0.09; diastolic: p = 0.33). Plasma caffeine concentrations were significantly increased post caffeine ingestion in all three groups of participants (p<0.05). Plasma epinephrine concentrations increased significantly in able-bodied (p = 0.002) and paraplegic (p = 0.032) but not in tetraplegic participants (p = 0.63). The influence of caffeine on the autonomic nervous system seems to depend on the level of lesion and the extent of the impairment. Therefore, tetraplegic participants may be less influenced by caffeine ingestion. Trial Registration ClinicalTrials.gov NCT02083328 PMID:27776149

  20. Double-blind procedure: an assessment in a study of lithium prophylaxis.

    Science.gov (United States)

    Stallone, F; Mendlewicz, J; Fieve, R R

    1975-02-01

    Fifty-seven patients with primary affective disorder who were in a double-blind outpatient study to evaluate the prophylaxis of lithium were questioned as to whether they believed they were receiving lithium or placebo. Research nurses who were 'blind' to the patients' medication and a close relative living with each patient were also questioned. Nearly all patients (96%) said they beleived they were receiving lithium, ascribing this belief in 63% of the cases to a perceived improvement in condition. In only 14% of the cases on lithium was the presence of side-effects implicated in the patients' beliefs. One of the three nurses had a correct guess rate in excess of chance expectancy. All nurses tended to be more accurate in their guesses in the cases of patients who had been in prophylactic trials of over 15 months' duration than for patients with briefer periods in the study. Patients' relatives were, as a group, extremely accurate, their correct guess rate exceeding chance expectancy at the 0-001 level.

  1. Our experience with Solcoseryl Eye-Gel in the treatment of corneal lesions. A randomised double-blind study (with 1 color plate).

    Science.gov (United States)

    Erbe, W; Herrmann, R; Körner, W F; Rohde-Germann, H; Straub, W

    1984-01-01

    A comparative study of Solcoseryl Eye-Gel versus a 2.4% cysteine eye-gel was carried out under controlled conditions (randomised and double-blind) on a total of 61 patients with corneal lesions (52 foreign body injuries, 9 corneal erosions). The results showed a marked superiority of Solcoseryl Eye-Gel with respect to more rapid healing and also with respect to the possible subsequent development of a corneal macula.

  2. Etodolac versus diclofenac: double-blind cross-over study in rheumatoid arthritis.

    Science.gov (United States)

    Ciompi, M L; Puccetti, L; Bazzichi, L; Remorini, E; Marotta, G

    1989-01-01

    A 14-day double-blind clinical study was conducted on 16 patients with clinically active rheumatoid arthritis to compare the effects of etodolac (600 mg daily) and diclofenac (150 mg daily). Admission criteria were: functional impairment between Steinbrocker's classes I to III, Ritchie's index greater than 10 and erythrocyte sedimentation rate greater than 25 mm/h, and finally active involvement of the small joints of the hands. Following a wash-out period of at least two days from their previous non-steroidal anti-inflammatory drugs, trial patients received etodolac or diclofenac for five consecutive days by random allocation; after that, and after another two day wash-out period, all patients were crossed-over to the alternate drug for another five consecutive days. One day before intake and on the last day of each treatment lap, each patient was examined in regard to the circadian grip strength (of the more severely affected hand), Ritchie's index and acute phase reactants; at the end of the second treatment period, subjective drug preference was explored. Grip strength was assessed by the patients themselves with a dynamometer at 08h00 and every two hours thereafter until 20h00. The overall daily value was calculated by measuring the area under curve (AUC) depicting the grip strength profile. Both groups of patients showed significant improvement of the Ritchie's index (p less than 0.01) and grip strength AUC (p less than 0.05), while taking medication, whereas no significant variations were noted in regard to the values of the acute phase parameters both between the two treatment groups, and within each treatment group. At termination, four patients expressed preference for etodolac, eight were in favour of diclofenac, and four gave an indifferent judgement. No statistically significant differences were detected between the two treatment groups; also no adverse events were seen in this short-term study. The results confirm the effectiveness and tolerability of

  3. Causes of visual impairment and blindness in children in three ecological regions of Nepal: Nepal Pediatric Ocular Diseases Study.

    Science.gov (United States)

    Adhikari, Srijana; Shrestha, Mohan K; Adhikari, Kamala; Maharjan, Nhukesh; Shrestha, Ujjowala D

    2015-01-01

    To study the causes of blindness and visual impairment in children in three ecologically diverse regions of Nepal. This is a baseline survey report of a 3-year longitudinal population-based study. One district each from the three ecological regions - Terai, Hills, and Mountains - was selected for the study. Village Development Committees from each district were selected by random sampling. Three community health workers were given training on vision screening and identification of abnormal ocular conditions in children. Health workers who examined children and collected data using pretested questionnaire performed house-to-house surveys. Children with abnormal vision or ocular conditions were referred to and examined by pediatric ophthalmologists. A total of 10,950 children aged 0-10 years, 5,403 from Terai, 3,204 from Hills, and 2,343 from Mountains, were enrolled in the study. Of them, 681 (6.2%) were nonresponders. The ratio of boys to girls was 1.03:1. Prevalence of blindness was 0.068% (95% confidence interval [CI] 0.02%-0.12%) and visual impairment was 0.097% (95% CI 0.04%-0.15%). Blindness was relatively more prevalent in Terai region (0.08%, 95% CI 0.02%-0.13%). The most common cause of blindness was amblyopia (42.9%) followed by congenital cataract. Corneal opacity (39%) was the most common cause of unilateral blindness. More than two-thirds of the causes that lead to blindness and visual impairment were potentially preventable. Further, nutritional and genetic studies are needed to determine the factors associated with ocular morbidity and blindness in these regions.

  4. A double-blind study of SB-220453 (Tonerbasat) in the glyceryltrinitrate (GTN) model of migraine

    DEFF Research Database (Denmark)

    Tvedskov, Jesper Filtenborg; Iversen, H K; Olesen, J

    2004-01-01

    The need for experimental migraine models increases as therapeutic options widen. In the present study, we investigated SB-220453 for efficacy in the glyceryltrinitrate (GTN) human experimental migraine model. SB-220453 is a novel benzopyran compound, which in animal models inhibits neurogenic...... inflammation, blocks propagation of spreading depression and inhibits trigeminal nerve ganglion stimulation-induced carotid vasodilatation. We included 15 patients with migraine without aura in a randomized double-blind crossover study. SB-220453 40 mg or placebo was followed by a 20-min GTN infusion. Headache...... no vascular or sympaticolytic activity with SB-220453. The study was terminated prematurely due to this interaction. GTN was consistent in producing headache and migraine that resembled the patients' usual spontaneous migraine. Nine patients had GTN on both study days. Peak headache score showed a trend...

  5. A Double-Blind Randomized Clinical Trial Comparing the Effect of Neostigmine and Metoclopramide on Gastric Residual Volume of Mechanically Ventilated ICU Patients

    Science.gov (United States)

    Gholipour Baradari, Afshin; Alipour, Abbas; Firouzian, Abolfazl; Moarab, Laleh; Emami Zeydi, Amir

    2016-01-01

    Background: In critically ill patients, enteral feeding through the nasogastric tube is the method of choice for nutritional support. Gastrointestinal feeding intolerance and disturbed gastric emptying are common challenges in these patients. The aim of this study was to compare the effect of Neostigmine and Metoclopramide on gastric residual volume (GRV) in mechanically ventilated ICU patients. Methods: In a double blind, randomized clinical trial, a total of 60 mechanically ventilated ICU patients with GRV >120 mL (3 hours after the last gavage), were randomly assigned into two groups A and B. At baseline and 6 hours later, patients in group A and B received intravenous infusion of neostigmine in a dose of 2.5 mg and metoclopramide in a dose of 10 mg in 100 ml of normal saline, within 30 minutes. Patients’ gastric residual volumes were evaluated before the beginning of the intervention, and 3, 6, 9 and 12 hours after the intervention. Results: After adjusting of other variables (Sex, BMI and ICU stay period) generalized estimating equation (GEE) model revealed that neostigmine treatment increased odds of GRV improvement compare to metoclopramide group (Estimate 1.291, OR= 0.3.64, 95% CI 1.07-12.34). However there is a statistically significant time trend (within-subject differences or time effect) regardless of treatment groups (P<0.001). The median time from intervention to GRV improvement was 6 hours (95% CI 3.75-8.25) and 9 hours (95% CI 7.38-10.17) in neostigmine and metoclopramide groups, respectively. This difference was statistically significant (P<0.05). Conclusion: It seems that neostigmine is more effective than metoclopramide in reducing GRV and improving gastric emptying in mechanically ventilated ICU patients without significant complication and this protocol may be effective on the tolerance of enteral feeding in ICU patients. Further well-designed randomized clinical trials are needed. PMID:28077899

  6. 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 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 (pmassage 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.

  7. Propofol versus Ketofol for Sedation of Pediatric Patients Undergoing Transcatheter Pulmonary Valve Implantation: A Double-blind Randomized Study

    Directory of Open Access Journals (Sweden)

    Rabie Soliman

    2017-01-01

    Full Text Available Objective: The study was done to compare propofol and ketofol for sedation of pediatric patients scheduled for elective pulmonary valve implantation in a catheterization laboratory. Design: This was a double-blind randomized study. Setting: This study was conducted in Prince Sultan Cardiac Centre, Saudi Arabia. Patients and Methods: The study included 60 pediatric patients with pulmonary regurge undergoing pulmonary valve implantation. Intervention: The study included sixty patients, classified into two groups (n = 30. Group A: Propofol was administered as a bolus dose (1–2 mg/kg and then a continuous infusion of 50–100 μg/kg/min titrated as needed. Group B: Ketofol was administered 1–2 mg/kg and then infusion of 20–60 μg/kg/min. The medication was prepared by the nursing staff and given to anesthetist blindly. Measurements: The monitors included heart rate, mean arterial blood pressure, respiratory rate, temperature, SPO2and PaCO2, Michigan Sedation Score, fentanyl dose, antiemetic medications, and Aldrete score. Main Results: The comparison of heart rate, mean arterial pressure, respiratory rate, temperature, SPO2and PaCO2, Michigan Sedation Score, and Aldrete score were insignificant (P > 0.05. The total fentanyl increased in Group A more than Group B (P = 0.045. The required antiemetic drugs increased in Group A patients more than Group B (P = 0.020. The durations of full recovery and in the postanesthesia care unit were longer in Group A than Group B (P = 0.013, P < 0.001, respectively. Conclusion: The use of propofol and ketofol is safe and effective for sedation of pediatric patients undergoing pulmonary valve implantation in a catheterization laboratory. However, ketofol has many advantages more than the propofol. Ketofol has a rapid onset of sedation, a rapid recovery time, decreased incidence of nausea and vomiting and leads to rapid discharge of patients from the postanesthesia care unit.

  8. Propofol versus Ketofol for Sedation of Pediatric Patients Undergoing Transcatheter Pulmonary Valve Implantation: A Double-blind Randomized Study.

    Science.gov (United States)

    Soliman, Rabie; Mofeed, Mohammed; Momenah, Tarek

    2017-01-01

    The study was done to compare propofol and ketofol for sedation of pediatric patients scheduled for elective pulmonary valve implantation in a catheterization laboratory. This was a double-blind randomized study. This study was conducted in Prince Sultan Cardiac Centre, Saudi Arabia. The study included 60 pediatric patients with pulmonary regurge undergoing pulmonary valve implantation. The study included sixty patients, classified into two groups (n = 30). Group A: Propofol was administered as a bolus dose (1-2 mg/kg) and then a continuous infusion of 50-100 μg/kg/min titrated as needed. Group B: Ketofol was administered 1-2 mg/kg and then infusion of 20-60 μg/kg/min. The medication was prepared by the nursing staff and given to anesthetist blindly. The monitors included heart rate, mean arterial blood pressure, respiratory rate, temperature, SPO2and PaCO2, Michigan Sedation Score, fentanyl dose, antiemetic medications, and Aldrete score. The comparison of heart rate, mean arterial pressure, respiratory rate, temperature, SPO2and PaCO2, Michigan Sedation Score, and Aldrete score were insignificant (P > 0.05). The total fentanyl increased in Group A more than Group B (P = 0.045). The required antiemetic drugs increased in Group A patients more than Group B (P = 0.020). The durations of full recovery and in the postanesthesia care unit were longer in Group A than Group B (P = 0.013, P < 0.001, respectively). The use of propofol and ketofol is safe and effective for sedation of pediatric patients undergoing pulmonary valve implantation in a catheterization laboratory. However, ketofol has many advantages more than the propofol. Ketofol has a rapid onset of sedation, a rapid recovery time, decreased incidence of nausea and vomiting and leads to rapid discharge of patients from the postanesthesia care unit.

  9. 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.

  10. A double-blind study of SB-220453 (Tonerbasat) in the glyceryltrinitrate (GTN) model of migraine

    DEFF Research Database (Denmark)

    Tvedskov, Jesper Filtenborg; Iversen, H K; Olesen, J

    2004-01-01

    The need for experimental migraine models increases as therapeutic options widen. In the present study, we investigated SB-220453 for efficacy in the glyceryltrinitrate (GTN) human experimental migraine model. SB-220453 is a novel benzopyran compound, which in animal models inhibits neurogenic...... inflammation, blocks propagation of spreading depression and inhibits trigeminal nerve ganglion stimulation-induced carotid vasodilatation. We included 15 patients with migraine without aura in a randomized double-blind crossover study. SB-220453 40 mg or placebo was followed by a 20-min GTN infusion. Headache......, scored 0-10, was registered for 12 h, and fulfillment of International Headache Society (IHS) criteria was recorded until 24 h. Four subjects had a hypotensive episode after SB-220453 plus GTN but none after GTN alone. The reaction was unexpected, since animal models and previous human studies had shown...

  11. Cerebellar stimulation for spastic cerebral palsy: preliminary report; on-going double blind study.

    Science.gov (United States)

    Schulman, J H; Davis, R; Nanes, M

    1987-01-01

    To date, June 1, 1986, 33 spastic cerebral palsy (CP) patients have taken part in a double blind study testing the safety and efficacy of chronic cerebellar stimulation (CCS) for reduction of spasticity and improvement in function. Seven U.S. surgical centers involving ten neurosurgeons have implanted the Neurolith 601 cerebellar stimulator supplied by Pacesetter Systems Inc. (Sylmar, CA). A pilot study was run with three patients at Stanford University (Stanford, CA) using taped-on real (strong) and dummy (weak) magnets to control the ON-OFF status. Following the pilot study, a magnetically controllable switch was placed in line between the Neurolith stimulator and the cerebellar lead to allow more reliable switching sequences for the study. The test battery included joint angle measurements (passive and active), motor performance testing, reaction time, hand dynamometry, grooved peg board placement, hand/foot tapping, and rotary pursuit testing. Testing only was done at presurgery. Testing and ON-OFF switching was performed following recovery from surgery and at one, two, and four months. After four months, the switch was left turned ON. Of the 30 patients using the implanted switch, 11 were dropped from the study and seven are still in progress. Of the 11 dropped from the study, four were due to switch problems and three were due to double blind protocol violations, i.e., the participants discovered the stimulus status. The remaining four were removed because of a broken lead, infection, or unrelated medical problems, or refusal to participate after implant. A preliminary analysis indicated that three-quarters of the patients have a demonstrable quantitative improvement during the time the stimulation was "ON." Three patients showed no significant change.

  12. 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.

  13. Treatment of Vertigo: A Randomized, Double-Blind Trial Comparing Efficacy and Safety of Ginkgo biloba Extract EGb 761 and Betahistine

    OpenAIRE

    Larysa Sokolova; Robert Hoerr; Tamara Mishchenko

    2014-01-01

    A multicenter clinical trial was performed to compare the efficacy and safety of Ginkgo biloba extract EGb 761 and betahistine at recommended doses in patients with vertigo. One hundred and sixty patients (mean age 58 years) were randomly assigned to double-blind treatment with EGb 761 (240 mg per day) or betahistine (32 mg per day) for 12 weeks. An 11-point numeric analogue scale, the Vertigo Symptom Scale—short form, the Clinical Global Impression Scales and the Sheehan Disability Scale wer...

  14. 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.

  15. The clinical anti-aging effects of topical kinetin and niacinamide in Asians: a randomized, double-blind, placebo-controlled, split-face comparative trial.

    Science.gov (United States)

    Chiu, Pin-Chi; Chan, Chih-Chieh; Lin, Hui-Min; Chiu, Hsien-Ching

    2007-12-01

    Kinetin and niacinamide are used in the cosmetic industry as anti-aging agents. Neither the interactive/additive effects of these compounds nor the anti-aging efficacy on Asian skin has been studied. Objective To assess the clinical anti-aging effects and efficacy differences between kinetin plus niacinamide and niacinamide alone vs. vehicle placebo in an Asian cohort. Fifty-two Taiwanese subjects were enrolled in a randomized, double-blind, placebo-controlled, split-face comparative study. Group 1 subjects were treated with kinetin 0.03% plus niacinamide 4%, whereas group 2 subjects received niacinamide 4%. The treatment formulation was applied on one side of the face, whereas a placebo was applied on the other for a period of 12 weeks. We used noninvasive biometrological instruments to evaluate a variety of skin parameters at baseline and at weeks 4, 8, and 12. Persistent and significant reductions in spot, pore, wrinkle, and evenness counts were found at weeks 8 and 12 in group 1. A significant increase in corneal hydration status was also evident at week 12, whereas persistent decreases in erythema index were apparent at 8 and 12 weeks. In group 2, significant reductions in pore and evenness counts at week 8 and wrinkle counts at week 12 were noted. We found kinetin and niacinamide exert a synergistic anti-aging effect. Our data suggest that these compounds have multiactive, multifunctional, and pluripotent effects on skin. They are also both promising to be included in the cutaneous anti-aging cosmeceuticals in the future.

  16. Evaluation of minimal dose of atracurium for cataract surgery in children: A prospective randomized double-blind study

    Science.gov (United States)

    Darlong, Vanlal; Garg, Rakesh; Pandey, Ravinder; Khokhar, Sudarshan; Chandralekha; Sinha, Renu; Punj, Jyotsna; Sinha, Rajesh

    2015-01-01

    Background: Cataract surgery when performed under general anesthesia, especially without neuromuscular blocking agents, eccentric position of the eye has been reported. However, no evidence exists for the need and optimal dose of neuromuscular blocking agents for surgical reasons when the anesthetic management may be done without its need. We hypothesize that the minimal dose atracurium may accomplish the surgical requirement of cataract surgery in children. Materials and Methods: After ethical committee approval, this double-blind, prospective, randomized study was conducted in children scheduled for cataract surgery under general anesthesia. Anesthesia was induced in a standardized manner and using laryngeal mask airway. The patients were randomized into four groups of 55 patients each and atracurium was administered as per group allocation: Group 0: No atracurium was administered; Group 50: Received atracurium at 50% dose of ED95; Group 75: Received atracurium at 75% dose of ED95; Group 100: Received atracurium of 100% dose of ED95. Surgeon was asked to grade surgical condition just after the stab incision in the cornea. The primary outcome variable included the need of atracurium supplementation based on grading of surgical conditions by the operating surgeon who was blinded to the randomized group. Results: The need of atracurium due to unacceptable surgical conditions based on surgeon satisfaction score was statistically significant when compared among the groups being maximum in Group 0 (P < 0.001). Also, the surgeon satisfaction score was statistically significant among the groups (P < 0.0001) with the least satisfaction in Group 0. The laryngeal mask airway (LMA) insertion score was statistically significant in the four groups (P - 0.001). However, number of attempts for LMA placement was comparable among the four groups (P - 0.766). Conclusion: We conclude that a balanced anesthetic technique including atracurium provided better surgical condition for

  17. Evaluation of minimal dose of atracurium for cataract surgery in children: A prospective randomized double-blind study

    Directory of Open Access Journals (Sweden)

    Vanlal Darlong

    2015-01-01

    Full Text Available Background: Cataract surgery when performed under general anesthesia, especially without neuromuscular blocking agents, eccentric position of the eye has been reported. However, no evidence exists for the need and optimal dose of neuromuscular blocking agents for surgical reasons when the anesthetic management may be done without its need. We hypothesize that the minimal dose atracurium may accomplish the surgical requirement of cataract surgery in children. Materials and Methods: After ethical committee approval, this double-blind, prospective, randomized study was conducted in children scheduled for cataract surgery under general anesthesia. Anesthesia was induced in a standardized manner and using laryngeal mask airway. The patients were randomized into four groups of 55 patients each and atracurium was administered as per group allocation: Group 0: No atracurium was administered; Group 50: Received atracurium at 50% dose of ED 95 ; Group 75: Received atracurium at 75% dose of ED 95 ; Group 100: Received atracurium of 100% dose of ED 95 . Surgeon was asked to grade surgical condition just after the stab incision in the cornea. The primary outcome variable included the need of atracurium supplementation based on grading of surgical conditions by the operating surgeon who was blinded to the randomized group. Results: The need of atracurium due to unacceptable surgical conditions based on surgeon satisfaction score was statistically significant when compared among the groups being maximum in Group 0 (P < 0.001. Also, the surgeon satisfaction score was statistically significant among the groups (P < 0.0001 with the least satisfaction in Group 0. The laryngeal mask airway (LMA insertion score was statistically significant in the four groups (P - 0.001. However, number of attempts for LMA placement was comparable among the four groups (P - 0.766. Conclusion: We conclude that a balanced anesthetic technique including atracurium provided better

  18. 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.

  19. Extracorporeal shock-wave treatment for tennis elbow. A randomised double-blind study.

    Science.gov (United States)

    Melikyan, E Y; Shahin, E; Miles, J; Bainbridge, L C

    2003-08-01

    The efficacy of extracorporeal shock-wave therapy for tennis elbow was investigated using a single fractionated dosage in a randomised, double-blind study. Outcomes were assessed using the Disabilities of Arm, Shoulder and Hand questionnaire, measurements of grip strength, levels of pain, analgesic usage and the rate of progression to surgery. Informed consent was obtained before patients were randomised to either the treatment or placebo group. In the final assessment, 74 patients (31 men and 43 women) with a mean age of 43.4 years (35 to 71), were included. None of the outcome measures showed a statistically significant difference between the treatment and control groups (p > 0.05). All patients improved significantly over time, regardless of treatment. Our study showed no evidence that extracorporeal shock-wave therapy for tennis elbow is better than placebo.

  20. Levetiracetam in primary orthostatic tremor: a double-blind placebo-controlled crossover study.

    Science.gov (United States)

    Hellriegel, Helge; Raethjen, Jan; Deuschl, G; Volkmann, Jens

    2011-11-01

    In a double-blind crossover study we evaluated the antitremor effect of a 4-week treatment with either escalating dosages of levetiracetam or placebo in orthostatic tremor. Twelve patients with orthostatic tremor participated in the study. Primary end point was improvement in stance duration. Secondary end points were total track length of the sway path and tremor total power. The patients' impression of impairment was assessed by a visual analog scale and quality of life by the SF-36. We found no significant effect of dosage or treatment on stance duration (P = .175), total track length (P = .690), total power (P = .280), or visual analog scale (P =.735). Neither was SF-36 differentially changed by levetiracetam or placebo (SF-36, Physical Component Summary: P = .079; SF-36, Mental Component Summary: P = .073). Side effects like dizziness, fatigue, or nausea were only mild to moderate. Levetiracetam is ineffective in the treatment of orthostatic tremor. Copyright © 2011 Movement Disorder Society.

  1. Antihirsutism activity of Fennel (fruits of Foeniculum vulgare) extract. A double-blind placebo controlled study.

    Science.gov (United States)

    Javidnia, K; Dastgheib, L; Mohammadi Samani, S; Nasiri, A

    2003-01-01

    Idiopathic hirsutism is defined as the occurrence of excessive male pattern hair growth in women who have a normal ovulatory menstrual cycle and normal levels of serum androgens. It may be a disorder of peripheral androgen metabolism. In this study we evaluated the clinical response of idiopathic hirsutism to topical Fennel extract. Fennel, Foeniculum vulgare, is a plant, which has been used as an estrogenic agent. The ethanolic extract of Fennel was obtained by using a soxhlete apparatus. In a double blind study, 38 patients were treated with creams containing 1%, 2% of Fennel extract and placebo. Hair diameter was measured and rate of growth was considered. The efficacy of treatment with the cream containing 2% Fennel is better than the cream containing 1% Fennel and these two were more potent than placebo. The mean values of hair diameter reduction was 7.8%, 18.3% and -0.5% for patients receiving the creams containing 1%, 2% and 0% (placebo) respectively.

  2. Gene Expression-Based Survival Prediction in Lung Adenocarcinoma: A Multi-Site, Blinded Validation Study

    Science.gov (United States)

    Shedden, Kerby; Taylor, Jeremy M.G.; Enkemann, Steve A.; Tsao, Ming S.; Yeatman, Timothy J.; Gerald, William L.; Eschrich, Steve; Jurisica, Igor; Venkatraman, Seshan E.; Meyerson, Matthew; Kuick, Rork; Dobbin, Kevin K.; Lively, Tracy; Jacobson, James W.; Beer, David G.; Giordano, Thomas J.; Misek, David E.; Chang, Andrew C.; Zhu, Chang Qi; Strumpf, Dan; Hanash, Samir; Shepherd, Francis A.; Ding, Kuyue; Seymour, Lesley; Naoki, Katsuhiko; Pennell, Nathan; Weir, Barbara; Verhaak, Roel; Ladd-Acosta, Christine; Golub, Todd; Gruidl, Mike; Szoke, Janos; Zakowski, Maureen; Rusch, Valerie; Kris, Mark; Viale, Agnes; Motoi, Noriko; Travis, William; Sharma, Anupama

    2009-01-01

    Although prognostic gene expression signatures for survival in early stage lung cancer have been proposed, for clinical application it is critical to establish their performance across different subject populations and in different laboratories. Here we report a large, training-testing, multi-site blinded validation study to characterize the performance of several prognostic models based on gene expression for 442 lung adenocarcinomas. The hypotheses proposed examined whether microarray measurements of gene expression either alone or combined with basic clinical covariates (stage, age, sex) can be used to predict overall survival in lung cancer subjects. Several models examined produced risk scores that substantially correlated with actual subject outcome. Most methods performed better with clinical data, supporting the combined use of clinical and molecular information when building prognostic models for early stage lung cancer. This study also provides the largest available set of microarray data with extensive pathological and clinical annotation for lung adenocarcinomas. PMID:18641660

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

    DEFF Research Database (Denmark)

    Pedersen, Inge Nygaard

    2016-01-01

    The aim of this study is to examine if postiive results of International Cochrane Reviews on Music Therapy and Schizophrenia can be confirmed by a randomized controlled double blinded study on music therapy for people suffering from schizophrenia with extensive negative symptoms in Denmark....... 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...

  4. Testing Children for Color Blindness

    Science.gov (United States)

    ... Stories Español Eye Health / News Testing Children for Color Blindness Written By: Shirley Dang Apr. 03, 2014 New study shows that kids can be tested for color blindness as soon as age 4, finds Caucasian boys ...

  5. Resurfacing of the patella in total knee arthroplasty. A prospective, randomized, double-blind study.

    Science.gov (United States)

    Barrack, R L; Wolfe, M W; Waldman, D A; Milicic, M; Bertot, A J; Myers, L

    1997-08-01

    During a two-year period, eighty-nine patients who were scheduled to have a total knee arthroplasty for the treatment of degenerative osteoarthrosis were randomly assigned to one of two groups: resurfacing of the patella or retention of the patella. All patients received the same posterior cruciate-sparing prosthesis, and all operations were performed by, or under the direct supervision of, one of us. Three patients died in the early postoperative period. The remaining eighty-six patients (118 knees; fifty-eight that had had resurfacing of the patella and sixty that had not) formed the study group. They were followed for a mean of thirty months (range, twenty-four to forty-four months). Evaluation was performed with use of the clinical scoring system of The Knee Society, a patient-satisfaction questionnaire, specific questions regarding patellofemoral symptoms and function, and radiographs. All clinical evaluations were performed by the same research nurse, without the involvement of a physician, in a blinded manner (neither the nurse nor the patient had knowledge of whether the patella had been resurfaced). Preoperatively, the mean Knee Society score, on a scale ranging from 0 to 200 points, was 89.7 points (range, 33 to 132 points); postoperatively, this score improved to a mean of 172.7 points (range, 98 to 200 points). With the numbers available for study, we could detect no significant difference between the knees that had had patellar resurfacing and those that had not with regard to the over-all score (p = 0.63), the subscore for pain (p = 0.56), or the subscore for function (p = 0.77). We also could detect no difference between the treatment groups, with the numbers available, with regard to patient satisfaction or the responses to questions involving the function of the patellofemoral joint, including the ability to exit from an automobile, to rise from a chair, and to climb stairs. Thirty-two patients had bilateral total knee replacement with resurfacing

  6. 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 (Pback pain can be concluded.

  7. [Periprostatic anaesthesic infiltration for prostatic biopsy: a prospective, randomized, double blind and placebo-controlled study].

    Science.gov (United States)

    Valero, Gonzalo; González, E U Roxana

    2005-06-01

    A prospective, randomized, double blind and placebo-controlled study to evaluate the effectiveness of periprostatic infiltration with lidocaine to reduce pain of prostatic biopsy. In a thirteen months period of time, 115 patients were randomized to receive 10 ml of lidocaine 1% (n=60) or saline (n=55). Evaluating the pain with visual analogue scale (0-10), the first group referred average pain of 3.83 and the second group of 6.87, being this difference clearly significant (panesthesic puncture. The periprostatic infiltration is easy to perform without complications and it is effective in reducing the pain of this procedure. It should be used as a routine procedure in prostatic biopsy.

  8. A randomized, double-blind, placebo-controlled trial comparing pethidine to metamizol for treatment of post-anaesthetic shivering

    Science.gov (United States)

    MONSÓ, A.; RIUDEUBAS, J.; BARBAL, F.; LAPORTE, J-R.; ARNAU, J. M.

    1996-01-01

    1Shivering is frequent during the post-anaesthetic recovery period, and there is no clear consensus about the best strategy for its treatment. We tested the efficacy of two commonly used analgesic drugs, pethidine and metamizol. 2A randomized, double-blind, placebo-controlled clinical trial was performed, including 104 adult patients who presented with post-anaesthetic shivering during the recovery from general anaesthesia. They were randomized to receive placebo (n=32), metamizol 25 mg kg−1 (n=37), or pethidine 0.4 mg kg−1 (n=35). The response to treatment was assessed 5, 15 and 45 min after drug administration, and the main outcome variable was complete suppression of shivering. 3The efficacy at 5, 15 and 45 min was as follows: placebo 6%, 16% and 37%; metamizol 13.5%, 32% and 76%, and pethidine 89%, 91% and 89%. With both active drugs the efficacy at all three time intervals was significantly higher than that with placebo (Pmetamizol were statistically significant (Pmetamizol produces a better post-anaesthetic shivering response than placebo, especially 15 and 45 min after drug administration; the efficacy of pethidine was the highest and the response to it appeared more quickly; however, at 45 min it was similar to that observed with metamizol. 5Both metamizol and pethidine suppress postanaesthetic shivering, but the latter induces a quicker and more reliable response. PMID:8877020

  9. Enhanced Chemosensory Detection of Negative Emotions in Congenital Blindness

    Directory of Open Access Journals (Sweden)

    Katrine D. Iversen

    2015-01-01

    Full Text Available It is generally acknowledged that congenitally blind individuals develop superior sensory abilities in order to compensate for their lack of vision. Substantial research has been done on somatosensory and auditory sensory information processing of the blind. However, relatively little information is available about compensatory plasticity in the olfactory domain. Although previous studies indicate that blind individuals have superior olfactory abilities, no studies so far have investigated their sense of smell in relation to social and affective communication. The current study compares congenitally 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 donors who had been watching excerpts from emotional movies showing amusement, fear, disgust, or sexual arousal. Our results show that congenitally blind subjects outperformed sighted controls in identifying fear from male donors. In addition, there was a strong tendency that blind individuals were also better in detecting disgust. Our findings reveal that congenitally blind individuals are better at identifying ecologically important emotions and provide new insights into the mechanisms of social and affective communication in blindness.

  10. 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

  11. 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

  12. Safety and efficacy assessment of two new leprosy skin test antigens: randomized double blind clinical study.

    Directory of Open Access Journals (Sweden)

    Becky L Rivoire

    Full Text Available New tools are required for the diagnosis of pre-symptomatic leprosy towards further reduction of disease burden and its associated reactions. To address this need, two new skin test antigens were developed to assess safety and efficacy in human trials.A Phase I safety trial was first conducted in a non-endemic region for leprosy (U.S.A.. Healthy non-exposed subjects (n = 10 received three titrated doses (2.5 µg, 1.0 µg and 0.1 µg of MLSA-LAM (n = 5 or MLCwA (n = 5 and control antigens [Rees MLSA (1.0 µg and saline]. A randomized double blind Phase II safety and efficacy trial followed in an endemic region for leprosy (Nepal, but involved only the 1.0 µg (high dose and 0.1 µg (low dose of each antigen; Tuberculin PPD served as a control antigen. This Phase II safety and efficacy trial consisted of three Stages: Stage A and B studies were an expansion of Phase I involving 10 and 90 subjects respectively, and Stage C was then conducted in two parts (high dose and low dose, each enrolling 80 participants: 20 borderline lepromatous/lepromatous (BL/LL leprosy patients, 20 borderline tuberculoid/tuberculoid (BT/TT leprosy patients, 20 household contacts of leprosy patients (HC, and 20 tuberculosis (TB patients. The primary outcome measure for the skin test was delayed type hypersensitivity induration.In the small Phase I safety trial, reactions were primarily against the 2.5 µg dose of both antigens and Rees control antigen, which were then excluded from subsequent studies. In the Phase II, Stage A/B ramped-up safety study, 26% of subjects (13 of 50 showed induration against the high dose of each antigen, and 4% (2 of 50 reacted to the low dose of MLSA-LAM. Phase II, Stage C safety and initial efficacy trial showed that both antigens at the low dose exhibited low sensitivity at 20% and 25% in BT/TT leprosy patients, but high specificity at 100% and 95% compared to TB patients. The high dose of both antigens showed lower specificity (70% and 60

  13. Safety and Efficacy Assessment of Two New Leprosy Skin Test Antigens: Randomized Double Blind Clinical Study

    Science.gov (United States)

    Rivoire, Becky L.; Groathouse, Nathan A.; TerLouw, Stephen; Neupane, Kapil Dev; Ranjit, Chaman; Sapkota, Bishwa Raj; Khadge, Saraswoti; Kunwar, Chatra B.; Macdonald, Murdo; Hawksworth, Rachel; Thapa, Min B.; Hagge, Deanna A.; Tibbals, Melinda; Smith, Carol; Dube, Tina; She, Dewei; Wolff, Mark; Zhou, Eric; Makhene, Mamodikoe; Mason, Robin; Sizemore, Christine; Brennan, Patrick J.

    2014-01-01

    Background New tools are required for the diagnosis of pre-symptomatic leprosy towards further reduction of disease burden and its associated reactions. To address this need, two new skin test antigens were developed to assess safety and efficacy in human trials. Methods A Phase I safety trial was first conducted in a non-endemic region for leprosy (U.S.A.). Healthy non-exposed subjects (n = 10) received three titrated doses (2.5 µg, 1.0 µg and 0.1 µg) of MLSA-LAM (n = 5) or MLCwA (n = 5) and control antigens [Rees MLSA (1.0 µg) and saline]. A randomized double blind Phase II safety and efficacy trial followed in an endemic region for leprosy (Nepal), but involved only the 1.0 µg (high dose) and 0.1 µg (low dose) of each antigen; Tuberculin PPD served as a control antigen. This Phase II safety and efficacy trial consisted of three Stages: Stage A and B studies were an expansion of Phase I involving 10 and 90 subjects respectively, and Stage C was then conducted in two parts (high dose and low dose), each enrolling 80 participants: 20 borderline lepromatous/lepromatous (BL/LL) leprosy patients, 20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients, 20 household contacts of leprosy patients (HC), and 20 tuberculosis (TB) patients. The primary outcome measure for the skin test was delayed type hypersensitivity induration. Findings In the small Phase I safety trial, reactions were primarily against the 2.5 µg dose of both antigens and Rees control antigen, which were then excluded from subsequent studies. In the Phase II, Stage A/B ramped-up safety study, 26% of subjects (13 of 50) showed induration against the high dose of each antigen, and 4% (2 of 50) reacted to the low dose of MLSA-LAM. Phase II, Stage C safety and initial efficacy trial showed that both antigens at the low dose exhibited low sensitivity at 20% and 25% in BT/TT leprosy patients, but high specificity at 100% and 95% compared to TB patients. The high dose of both antigens

  14. Intrathecal Baclofen in Children with Spastic Cerebral Palsy: A Double-Blind, Randomized, Placebo-Controlled, Dose-Finding Study

    Science.gov (United States)

    Hoving, Marjanke A.; van Raak, Elisabeth P. M.; Spincemaille, Geert H. J. J.; Palmans, Liesbeth J.; Sleypen, Frans A. M.; Vles, Johan S. H.

    2007-01-01

    Intrathecal baclofen (ITB) therapy can be very effective in the treatment of intractable spasticity, but its effectiveness and safety have not yet been thoroughly studied in children with cerebral palsy (CP). The aims of this double-blind, randomized, placebo-controlled, dose-finding study were to select children eligible for continuous ITB…

  15. 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…

  16. Comparative study of budesonide as a nebulized suspension vs pressurized metered-dose inhaler in adult asthmatics

    DEFF Research Database (Denmark)

    Bisgaard, H; Nikander, K; Munch, E

    1998-01-01

    The study objective was to compare the effect of budesonide administered as a nebulized suspension as compared to a spray with a spacer in adult asthmatics. In a double-blind, double-dummy crossover study, 26 adult patients with moderately severe unstable asthma were randomized to three 4-week...

  17. Comparative analysis of two different alar base sutures after Le Fort I osteotomy: randomized double-blind controlled trial.

    Science.gov (United States)

    Ritto, Fabio G; Medeiros, Paulo José; de Moraes, Márcio; Ribeiro, Danilo Passeado Branco

    2011-02-01

    The aim of this prospective study was to analyze the efficacy of a new alar base cinch suture by comparing it with the commonly used cinch suture described by Schendel and Delaire in Dr. William Bell's book. Thirty-five patients submitted to maxillary impaction and/or advancements of ≥ 3 mm were randomly divided into 2 groups. Group 1 received an extra oral alar base cinch suture, and patients from group 2 received the classic intraoral suture. Alar and alar base width were measured before and after surgery in digital photographs, with the patient's head in a submental oblique view. Data were reported as means and standard deviations, and difference between groups were determined using Welch t test. A P value of alar base widening was 1.38 mm in group 1 and 2.5 mm in group 2, and mean alar widening was 1.40 mm in group 1 and 2.31 mm in group 2. The difference was statistically significant (P alar base cinch suture was more effective in maintaining preoperative Alar and alar base width compared with classic intraoral nasal suture. Copyright © 2011 Mosby, Inc. All rights reserved.

  18. Panax Ginseng in combination with brewers' yeast (Gerivet) as a stimulant for geriatric dogs: a controlled-randomized blinded study.

    Science.gov (United States)

    Hielm-Björkman, A; Reunanen, V; Meri, P; Tulamo, R-M

    2007-08-01

    The study was performed on two groups of dogs, one (n = 41) given Ginseng (Panax Ginseng) together with brewers' yeast (Saccharomyces cerevisae) and the other (n = 39) given only brewers' yeast (control group, but not a true placebo), for 8 weeks. Using a questionnaire and three visual analogue scales, the blinded owners evaluated the dogs before the trial, weekly for the 8 weeks of the trial and twice, at 12th and 16th weeks, after the trial (follow-up). At 8th, 12th and 16th weeks the owners also answered questions concerning what treatment their dogs likely had been getting, willingness to continue medication and the dogs' general status. The changes from baseline to the end of the treatment period in the variable scores were calculated for each dog and used in statistics. Panax Ginseng plus yeast significantly improved all evaluated variables within the group. Four of the seven primary (mentally) outcome measures were significant when comparing the changes in the Ginseng group with the control group, and six of the seven were significant when compared to an external group. As the secondary (physical) outcome measures were significantly better in both the Ginseng and the control group compared to the external group, it indicates that brewers' yeast is the ingredient that has impact on physical performance. No significant changes in blood- or urine analyses and no side effects were seen.

  19. Roxatidine versus ranitidine in the treatment of duodenal ulcers: a randomized double-blind controlled multicentre study in Singapore.

    Science.gov (United States)

    Fock, K M; Kang, J Y; Ng, H S; Ng, T M; Gwee, K A; Lim, C C

    1995-01-01

    Roxatidine acetate, a new H2 receptor antagonist, was compared with ranitidine in the treatment of duodenal ulcers in a double-blind multicentre study. Eighty-four patients with endoscopically proven duodenal ulcer were randomized to receive 150 mg roxatidine acetate or 300 mg ranitidine at bedtime. Repeat endoscopy was performed after 4 weeks (25-33 days) and if the ulcer had not healed, another endoscopy was performed after a further 4 weeks of treatment. Using per protocol analysis 73.6% of ulcers treated with roxatidine healed at 4 weeks compared to 72.2% of ulcers treated with ranitidine (P = NS). The healing rates at 8 weeks were 92% with roxatidine and 83.3% with ranitidine (P = NS). Using equivalence tests, the healing rate of roxatidine was found to be equivalent to that of ranitidine within a 20% region. Roxatidine users took significantly less antacids than ranitidine users (P roxatidine or ranitidine. Roxatidine is a safe effective drug in the treatment of duodenal ulcers with a healing rate comparable to that of ranitidine.

  20. A Prospective, Randomized, Single-Blinded, Head-to-Head Long-Term Outcome Study, Comparing Intrathecal (IT) Boluses With Continuous Infusion Trialing Techniques Prior to Implantation of Drug Delivery Systems (DDS) for the Treatment of Severe Intractable Chronic Nonmalignant Pain.

    Science.gov (United States)

    Hamza, Maged; Doleys, Daniel M; Saleh, Islam A; Medvedovsky, Andrew; Verdolin, Michael H; Hamza, Monalyce

    2015-10-01

    The study aims to compare intrathecal (IT) boluses to continuous infusion trialing techniques prior to implantation of drug delivery systems (DDS) for the treatment of severe intractable chronic nonmalignant pain. This is a prospective, randomized, head-to-head long-term outcome study. Forty patients with comparable patient demographics were randomly assigned to two cohorts. Cohort A trialed with intermittent boluses; Cohort B trialed with continuous infusion. One patient failed trial in each group. Nineteen patients were implanted in each group. Follow-up was for 36 months with intervals at 6, 12, 18, 24, 36 months. The Brief Pain Inventory was used was used for assessment. We used the Brief Pain Inventory to measure pain (worst and average), physical function (walking, normal work, and general activity), behavioral function (mood, sleep, and relations with others), IT dose, and oral opioid use. We observed statistically significant reduction in pain and improvement of function in both cohorts following DDS implantation throughout the observation period. The IT dose remained virtually unchanged throughout as well, with overall limited dose escalation. Oral opioid use was significantly reduced. There was no statistically significant difference in prediction of trial success or long-term outcomes between the two cohorts. Low-dose IT opioids via DDS can provide significant and long-lasting reduction in pain, and improvement in function (physical and behavioral) for patients with chronic nonmalignant pain. The two trialing techniques tested, intermittent boluses, and continuous infusion delivered intrathecally showed no clinical significance difference in terms of predicting trial success or long-term outcomes. © 2015 International Neuromodulation Society.

  1. Efficacy and safety of drotaverine hydrochloride in irritable bowel syndrome: A randomized double-blind placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Ramesh R Rai

    2014-01-01

    Full Text Available Backgrounds/Aims: To study the efficacy and safety of drotaverine hydrochloride (HCl 80 mg tablet given thrice a day in the symptomatic relief of patients with irritable bowel syndrome (IBS. Patients and Methods: The study was a multicentric, randomized, double-blind, placebo-controlled parallel group study performed at three centers. The patients who fulfilled Rome II Criteria of IBS were included in the study. A total of 180 patients with IBS were randomized to drotaverine and placebo treatment groups. Abdominal pain and stool frequency were measured every week in both the groups for all the 4 weeks of treatment duration. Subject Global Assessment of Relief (SGA of IBS symptoms was assessed at the end of the study. Appropriate statistical analysis was done using SPSS software. Statistical Analysis Used: Mann-Whitney U-test (two-tailed, Wilcoxon signed ranks test, and McNemar tests. Results: Pain frequency decreased significantly (P < 0.01 in 22 (25.9%, 51 (60%, and 66 (77.7% patients in the drotaverine group, at the end of 2 nd , 3 rd , and 4 th weeks, respectively, as compared with 8 (9.4%, 18 (21.2%, and 26 (30.6% in the placebo group. Pain severity scores also decreased significantly in the drotaverine group 66 (77.7% as compared with placebo 26 (30.6% after 4 weeks. Drotaverine HCl was shown to provide significant improvement (P < 0.01 in global relief in abdominal pain as perceived by the patient (85.9% vs 39.5% and the clinician (82.4% vs 36.5% in the drotaverine group as compared with placebo. There is significant (P < 0.01 improvement in stool frequency in drotaverine HCl treatment group as compared with placebo. The drug is well tolerated without any major side effects. Conclusions: A 4-week treatment with drotaverine significantly improves abdominal symptoms in patients with IBS.

  2. The Influence Studies in Comparative Literature

    Institute of Scientific and Technical Information of China (English)

    张宏莹

    2010-01-01

    Comparative literature arose in the 19th century,the approach adopted for its influence study has been developed and diversified in different eras,in this article,the influence study in comparative literature through a reading culture is discussed in order to reveal in what aspects the reading culture may cut across the regional border of influence study.

  3. 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...... better in detecting disgust. Our findings reveal that congenitally blind individuals are better at identifying ecologically important emotions and provide new insights into the mechanisms of social and affective communication in blindness....... donors who had been watching excerpts from emotional movies showing amusement, fear, disgust, or sexual arousal. Our results show that congenitally blind subjects outperformed sighted controls in identifying fear from male donors. In addition, there was a strong tendency that blind individuals were also...

  4. 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...... donors who had been watching excerpts from emotional movies showing amusement, fear, disgust, or sexual arousal. Our results show that congenitally blind subjects outperformed sighted controls in identifying fear from male donors. In addition, there was a strong tendency that blind individuals were also...... better in detecting disgust. Our findings reveal that congenitally blind individuals are better at identifying ecologically important emotions and provide new insights into the mechanisms of social and affective communication in blindness....

  5. Comparing primary and secondary wound healing discomfort after mandibular third molar surgery: a randomized, double-blind clinical trial.

    Science.gov (United States)

    Refo'a, Youshiaho; Ouatik, Nabil; Golchin, Foroogh; Mahboobi, Nima

    2011-01-01

    Extraction of impacted mandibular third molars is one of the most common procedures in the oral cavity and often is followed by pain, swelling, and postextraction alveolitis and trismus. It has been suggested that postoperative discomfort is in relation to the type of surgical wound healing. The aim of this study was to compare pain, swelling, and maximum mouth opening in two groups of patients with primary and secondary wound healing after impacted mandibular third molar surgery. Thirty-two patients were enrolled in this study and randomly divided into two equal groups, quantitatively and by gender. After the surgical procedures, 16 patients received primary wound closure, while the other 16 participants received secondary wound closure. A visual analog scale was used to collect pain data three days after the surgeries. A checklist was used to record data regarding swelling size and maximum mouth opening before, immediately following, three days after, and one week after surgery. Frequency tests and a t-test were used for statistical analysis and a P value of complications such as pain, maximal mouth opening, and swelling size after impacted mandibular third molar extractions.

  6. No Improved Performance With Repeated-Sprint Training in Hypoxia Versus Normoxia: A Double-Blind and Crossover Study.

    Science.gov (United States)

    Montero, David; Lundby, Carsten

    2017-02-01

    Few recent studies indicate that short-term repeated-sprint (RS) training in hypoxia (RSH) improves RS performance compared with identical training under normoxic conditions (RSN) in endurance-trained subjects. To determine the effects of RSH against RSN on RS performance under normoxic and moderate hypoxic conditions, using a randomized, doubleblind, crossover experimental design. Fifteen endurance-trained male subjects (age 25 ± 4 y) performed 4 wk of RS training (3 sessions/wk) in normobaric hypoxia (RSH, FiO2 = 13.8%) and normoxia (RSN, FiO2 = 20.9%) in a crossover manner. Before and after completion of training, RS tests were performed on a cycle ergometer with no prior exercise (RSNE), after an incremental exercise test (RSIE), and after a time-trial test (RSTT) in normoxia and hypoxia. Peak power outputs at the incremental exercise test and time-trial performance were unaltered by RSH in normoxia and hypoxia. RS performance was generally enhanced by RSH, as well as RSN, but there were no additional effects of RSH over RSN on peak and mean sprint power output and the number of repeated sprints performed in the RSNE, RSIE, and RSTT trials under normoxic and hypoxic conditions. The present double-blind crossover study indicates that RSH does not improve RS performance compared with RSN in normoxic and hypoxic conditions in endurance-trained subjects. Therefore, caution should be exercised when proposing RSH as an advantageous method to improve exercise performance.

  7. Efficacy of grass-maize pollen oral immunotherapy in patients with seasonal hay-fever: a double-blind study.

    Science.gov (United States)

    Van Niekerk, C H; De Wet, J I

    1987-11-01

    Forty patients with a well-documented history of seasonal hay fever and a positive skin-prick test specific to grass pollen, including Bermuda grass and maize pollen (Zea maize), were allocated randomly on a double-blind basis to receive either an oral mixed grass-maize pollen extract or a matched placebo during the 1981/1982 grass pollen season. After 12 months the code was broken and patients on placebo were transferred to active therapy while patients on active therapy continued with maintenance therapy for another 12 months during the 1982/1983 grass pollen season. The assessment of the effect of the orally administered grass-maize pollen extract was on the clinical symptoms. During the first year the patients on active therapy had significantly fewer hay fever symptoms during the summer months compared with the placebo group. During the second study year, with all patients on active therapy, both groups had markedly milder symptoms compared with the placebo group. Side-effects were negligible. This study concludes that oral immunotherapy with grass-maize pollen extract in grass pollen-sensitive seasonal hay fever patients is safe and effective.

  8. Effect of pulsed electromagnetic field therapy on experimental pain: A double-blind, randomized study in healthy young adults.

    Science.gov (United States)

    Beaulieu, Karen; Beland, Patricia; Pinard, Marilee; Handfield, Guilène; Handfield, Nicole; Goffaux, Philippe; Corriveau, Hélène; Léonard, Guillaume

    2016-01-01

    Previous studies suggested that pulsed electromagnetic field (PEMF) therapy can decrease pain. To date, however, it remains difficult to determine whether the analgesic effect observed in patients are attributable to a direct effect of PEMF on pain or to an indirect effect of PEMF on inflammation and healing. In the present study, we used an experimental pain paradigm to evaluate the direct effect of PEMF on pain intensity, pain unpleasantness, and temporal summation of pain. Twenty-four healthy subjects (mean age 22 ± 2 years; 9 males) participated in the experiment. Both real and sham PEMF were administered to every participant using a randomized, double-blind, cross-over design. For each visit, PEMF was applied for 10 minutes on the right forearm using a portable device. Experimental pain was evoked before (baseline) and after PEMF with a 9 cm(2) Pelletier-type thermode, applied on the right forearm (120 s stimulation; temperature individually adjusted to produce moderate baseline pain). Pain intensity and unpleasantness were evaluated using a 0-100 numerical pain rating scale. Temporal summation was evaluated by comparing pain intensity ratings obtained at the end of tonic nociceptive stimulation (120 s) with pain intensity ratings obtained after 60 s of stimulation. When compared to baseline, there was no change in pain intensity and unpleasantness following the application of real or sham PEMF. PEMF did not affect temporal summation. The present observations suggest that PEMF does not directly influence heat pain perception in healthy individuals.

  9. 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

  10. EFFECTIVENESS OF THORACIC CORE CONDITIONING USING STRETCH POLE FOR COMMUNITY ELDERLY WITH MODERATE COPD- A SINGLE BLIND STUDY

    Directory of Open Access Journals (Sweden)

    Kritica Boruah

    2014-02-01

    Full Text Available Back ground and introduction: Thoracic Core conditioning exercises are found to be effective in increasing chest expansion in healthy middle aged individuals. The purpose is to find the short term effect of thoracic core conditioning using stretch pole on improving thoracic expansion, intensity of perceived exertion of breathlessness and functional performance for community elderly with moderate COPD. Method: A Single blinded experimental study design, 40 subjects with moderate COPD randomized 20 subjects into each Study and Control group. Study group received thoracic core conditioning exercises with stretch pole while Control group received thoracic core conditioning exercises without stretch pole for one week. Subjects were followed up after one week post intervention where no intervention was given during follow up week. Results: Analysis using RMANOVA found that there was a statistically significant (p<0.05 greater percentage of improvement in Chest expansion, intensity of perceived exertion and functional performance following one week of intervention in Study group when compared with Control Group. During follow-up there is statistically significant greater percentage of maintenance of improvements were found in study group than control group. Conclusion: It is concluded that thoracic core conditioning exercises with stretch pole found to be more effective than without stretch pole in short term improving chest expansion, intensity of perceived exertion and functional performance in community elderly with moderate COPD.

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

    Science.gov (United States)

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

    2017-01-01

    Abstract 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

  12. Double-blind, randomized, double-dummy clinical trial comparing the efficacy of ketorolac trometamol and naproxen for acute low back pain

    Directory of Open Access Journals (Sweden)

    Plapler PG

    2016-06-01

    Full Text Available Pérola Grinberg Plapler,1 Morton Aaron Scheinberg,2 Christina da Cunha Ecclissato,3 Monalisa Fernanda Bocchi de Oliveira,3 Roberto Bleuel Amazonas31Orthopedic and Traumatology Institute of Clinical Hospital, University of São Paulo, 2Clinical Research Center Hospital AACD, São Paulo, 3NC Group Medical Affairs, Hortolândia, São Paulo, Brazil Background: Nonsteroidal anti-inflammatory drugs (NSAIDs are the most common type of medication used in the treatment of acute pain. Ketorolac trometamol (KT is a nonnarcotic, peripherally acting nonsteroidal anti-inflammatory drug with analgesic effects comparable to certain opioids.Objective: The aim of this study was to compare the efficacy of KT and naproxen (NA in the treatment of acute low back pain (LBP of moderate-to-severe intensity.Patients and methods: In this 10-day, Phase III, randomized, double-blind, double-dummy, noninferiority trial, participants with acute LBP of moderate-to-severe intensity as determined through a visual analog scale (VAS were randomly assigned in a 1:1 ratio to receive sublingual KT 10 mg three times daily or oral NA 250 mg three times daily. From the second to the fifth day of treatment, if patient had VAS >40 mm, increased dosage to four times per day was allowed. The primary end point was the reduction in LBP as measured by VAS. We also performed a post hoc superiority analysis.Results: KT was not inferior to NA for the reduction in LBP over 5 days of use as measured by VAS scores (P=0.608 for equality of variance; P=0.321 for equality of means and by the Roland–Morris Disability Questionnaire (P=0.180 for equality of variance test; P=0.446 for equality of means using 95% confidence intervals. The percentage of participants with improved pain relief 60 minutes after receiving the first dose was higher in the KT group (24.2% than in the NA group (6.5%; P=0.049. The most common adverse effects were heartburn, nausea, and vomiting.Conclusion: KT is not inferior

  13. Sulfadoxine-pyrimethamine-based combinations for malaria: a randomised blinded trial to compare efficacy, safety and selection of resistance in Malawi.

    Directory of Open Access Journals (Sweden)

    David J Bell

    Full Text Available BACKGROUND: In Malawi, there has been a return of Plasmodium falciparum sensitivity to chloroquine (CQ since sulfadoxine-pyrimethamine (SP replaced CQ as first line treatment for uncomplicated malaria. When used for prophylaxis, Amodiaquine (AQ was associated with agranulocytosis but is considered safe for treatment and is increasingly being used in Africa. Here we compare the efficacy, safety and selection of resistance using SP or CQ+SP or artesunate (ART+SP or AQ+SP for the treatment of uncomplicated falciparum malaria. METHODOLOGY AND FINDINGS: 455 children aged 1-5 years were recruited into a double-blinded randomised trial comparing SP to the three combination therapies. Using intention to treat analysis with missing outcomes treated as successes, and without adjustment to distinguish recrudescence from new infections, the day 28 adequate clinical and parasitological response (ACPR rate for SP was 25%, inferior to each of the three combination therapies (p<0.001. AQ+SP had an ACPR rate of 97%, higher than CQ+SP (81% and ART+SP (70%, p<0.001. Nineteen children developed a neutropenia of study confirms the return of CQ sensitivity in Malawi and importantly, shows no evidence of the re-emergence of pfcrt 76T after treatment with CQ or AQ. Given the safety record of AQ when used as a prophylaxis, our observations of marked falls in neutrophil counts in the AQ+SP group requires further scrutiny. TRIAL REGISTRATION

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

    Directory of Open Access Journals (Sweden)

    Ramya Shetty

    2014-01-01

    Conclusion: 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."

  15. Aprotinin and transfusion requirements in orthotopic liver transplantation : a multicentre randomised double-blind study

    NARCIS (Netherlands)

    Porte, RJ; Molenaar, IQ; Begliomini, B; Groenland, THN; Januszkiewicz, A; Lindgren, L; Palareti, G; Hermans, J; Terpstra, OT

    2000-01-01

    Background Intraoperative hyperfibrinolysis contributes to bleeding during adult orthotopic liver transplantation. We aimed to find out whether aprotinin, a potent antifibrinolytic agent, reduces blood loss and transfusion requirements. Methods We did a randomised, double-blind placebo-controlled tr

  16. Project Word-Back: Exploratory Follow-Up Study on Deaf-Blind (Rubella) Children in California.

    Science.gov (United States)

    Scheffelin, Edward J.

    Project Word-Back, an exploratory followup study of 21 young deaf-blind (Rubella) children (6 to 9 years old), was conducted to establish a tentative reference source of information, obtain teacher estimates on selected aspects of the current functioning level of a sample of children, and provide basic data from which hypotheses may be formulated…

  17. Sulfasalazine in the treatment of juvenile chronic arthritis - A randomized, double-blind, placebo-controlled, multicenter study

    NARCIS (Netherlands)

    Fiselier, TJW; Franssen, MJAM; Zwinderman, AH; ten Cate, R; van Suijlekom-Smit, LWA; van Luijk, WHJ; van Soesbergen, RM; Wulffraat, NM; Oostveen, JCM; Kuis, W; Dijkstra, PF; van Ede, CFP; Dijkmans, BAC

    1998-01-01

    Objective. To assess the efficacy, tolerability, and safety of sulfasalazine (SSZ) in the treatment of juvenile chronic arthritis (JCA). Methods. we conducted a 24-week randomized, placebo-controlled, double-blind, multicenter study of patients with active JCA of both oligoarticular and polyarticula

  18. Effects of magnetic stray fields from a 7 Tesla MRI scanner on neurocognition: a double-blind randomised crossover study

    NARCIS (Netherlands)

    van Nierop, L.E.|info:eu-repo/dai/nl/323065384; Slottje, P.|info:eu-repo/dai/nl/299345351; van Zandvoort, M.J.; de Vocht, F.; Kromhout, H.|info:eu-repo/dai/nl/074385224

    2012-01-01

    OBJECTIVE This study characterises neurocognitive domains that are affected by movement-induced time-varying magnetic fields (TVMF) within a static magnetic stray field (SMF) of a 7 Tesla (T) MRI scanner. METHODS Using a double-blind randomised crossover design, 31 healthy volunteers were tested in

  19. Effects of magnetic stray fields from a 7 Tesla MRI scanner on neurocognition: a double-blind randomised crossover study

    NARCIS (Netherlands)

    van Nierop, L.E.; Slottje, P.; van Zandvoort, M.J.; de Vocht, F.; Kromhout, H.

    2012-01-01

    OBJECTIVE This study characterises neurocognitive domains that are affected by movement-induced time-varying magnetic fields (TVMF) within a static magnetic stray field (SMF) of a 7 Tesla (T) MRI scanner. METHODS Using a double-blind randomised crossover design, 31 healthy volunteers were tested in

  20. 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…

  1. Comparison of bolus remifentanil versus bolus fentanyl for blunting cardiovascular intubation responses in children: a randomized, double-blind study

    Institute of Scientific and Technical Information of China (English)

    YANG Quan-yong; XUE Fu-shan; LIAO Xu; LIU He-ping; LUO Mao-ping; XU Ya-chao; LIU Yi; ZHANG Yan-ming

    2009-01-01

    Background The authors found no study to compare the efficacy of bolus dose fentanyl and remifentanil blunting the cardiovascular intubation response in children, so they designed this randomized, double-blind clinical study to assess the effects of remifentanil 2 ug/kg and fentanyl 2 ug/kg by bolus injection on the cardiovascular intubation response in healthy children.Methods One hundred and two children, the American Society of Anesthesiologists (ASA) physical status 1-2 and scheduled for elective plastic surgery under general anesthesia, were randomly divided into one of two groups to receive the following treatments in a double blind manner: remifentanil 2 ug/kg (Group R) and fentanyl 2 ug/kg (Group F) when anesthesia was induced with propofol and vecuronium. The orotracheal intubation was performed using a direct laryngoscope. Blood pressure (BP) and heart rate (HR) were recorded before anesthesia induction (baseline values), immediately before intubation, at intubation and every minute for 5 minutes after intubation. The percent changes of systolic blood pressure (SBP) and HR relative to baseline values and the rate pressure product (RPP) at every observing point were calculated. The incidences of SBP and HR percent changes >30% of baseline values and RPP >22 000 during the observation were recorded. Results There were no significant differences between groups in the demographic data, baseline values of BP and HR and the intubation time. As compared to baseline values, BP, HR and RPP at intubation and their maximum values during observation increased significantly in Group F, but they all decreased significantly in Group R. BP, HR and RPP at all observed points, and their maximum values during the observation, were significantly different between groups. There were also significant differences between groups in the percent change of SBP and HR relative to baseline values at all observed points and their maximum percent changes during the observation. The

  2. A study and extension of second-order blind source separation to operational modal analysis

    Science.gov (United States)

    Antoni, J.; Chauhan, S.

    2013-02-01

    Second-order blind source separation (SOBSS) has gained recent interest in operational modal analysis (OMA), since it is able to separate a set of system responses into modal coordinates from which the system poles can be extracted by single-degree-of-freedom techniques. In addition, SOBSS returns a mixing matrix whose columns are the estimates of the system mode shapes. The objective of this paper is threefold. First, a theoretical analysis of current SOBSS methods is conducted within the OMA framework and its precise conditions of applicability are established. Second, a new separation method is proposed that fixes current limitations of SOBSS: It returns estimate of complex mode shapes, it can deal with more active modes than the number of available sensors, and it shows superior performance in the case of heavily damped and/or strongly coupled modes. Third, a theoretical connection is drawn between SOBSS and stochastic subspace identification (SSI), which stands as one of the points of reference in OMA. All approaches are finally compared by means of numerical simulations.

  3. Clonidine versus tramadol for post spinal shivering during caesarean section: A randomized double blind clinical study

    Directory of Open Access Journals (Sweden)

    Velayudha S Reddy

    2011-01-01

    Full Text Available Background : Control of post spinal shivering is essential for optimal perioperative care, which can be achieved either by oral or parental medications. The present study is designed to evaluate the efficacy and safety of intravenous low-dose clonidine and tramadol in the treatment of post spinal shivering. Materials and Methods : In this prospective, a double blind, randomized study, 90 ASA grade I or II, parturients aged 18 - 35 years, undergoing caesarean section under spinal anaesthesia, who subsequently developed shivering grade 3 or 4, were randomized into two groups, to receive either clonidine or tramadol. The efficacy and response rate of the study drugs were evaluated and recorded. Side effects like, nausea, vomiting, hypotension, bradycardia, dry mouth, sedation, skin rash and headache, if present, were recorded. All data were analyzed by using the Chi square test and the Z-test. Results : There were significant differences in the response rate between the drugs (P < 0.05. Time taken from the starting of treatment to cessation of shivering was significantly less with the tramadol group (P < 0.05, however, the frequency of nausea, vomiting, sedation and headache were also significantly more in the tramadol group Conclusion : In our study we concluded that both clonidine and tramadol control shivering. However, the response rate was higher and time taken to control shivering was lesser with tramadol, but the response rate and the side effects were lesser with clonidine.

  4. Oxiracetam in dementia: a double-blind, placebo-controlled study.

    Science.gov (United States)

    Bottini, G; Vallar, G; Cappa, S; Monza, G C; Scarpini, E; Baron, P; Cheldi, A; Scarlato, G

    1992-09-01

    A multicentre, double-blind, between-patient study was carried out to evaluate the efficacy and tolerability of oxiracetam (800 mg tablet), in comparison with placebo, each given twice daily for 12 weeks to patients suffering from primary degenerative, multi-infarct or mixed dementia. Efficacy was assessed by a neuropsychological battery (simple reaction time, controlled associations, short story, Raven's Progressive Matrices, token test, digit span, word list learning), administered at the beginning and at the end of the study, and by a quality of life scale, administered at entry and after 6 and 12 weeks treatment. Sixty-five patients (28 men, 37 women, mean age 71 yrs) were enrolled; 58 completed the study: 2 on oxiracetam were withdrawn because of poor tolerability, 2 (one in each group) were withdrawn for poor compliance, one (on oxiracetam) for the occurrence of a transient ischaemic attack (defined as not related to the treatment) and 2 for administrative reasons. A significantly (p < 0.01) different effect in favour of oxiracetam was observed on the quality of life scale, and confirmed by significant (defined according to the Bonferroni technique) differences in some neuropsychological tests (e.g. controlled associations, short story). Four patients in the oxiracetam group complained of a total of 5 unwanted effects, and 1 on placebo complained of 3 unwanted effects, but none of them was withdrawn from the study.

  5. 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

  6. 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

  7. Bupropion in adults with Attention-Deficit/Hyperactivity Disorder: a randomized, double-blind study.

    Directory of Open Access Journals (Sweden)

    Mehdi Hamedi

    2014-09-01

    Full Text Available Attention-Deficit/Hyperactivity Disorder is one of the most common mental disorders in childhood, and it continues to adulthood without proper treatment. Stimulants have been used in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD for many years, and the efficacy of methylphenidate in the treatment of adults with ADHD has been proven to be acceptable according to meta-analysis studies. However, there are some concerns about stimulants. Finding other effective medications for the treatment of adult ADHD seems necessary. We hypothesized bupropion could be effective in the treatment of adult ADHD because some theoretical and experimental evidence exists to support efficacy of this medication. Forty-two patients with a diagnosis of ADHD, according to the revised fourth edition of the Diagnostic and Statistical Manual of Mental Disorders, were randomized to receive 150 mg/day bupropion or placebo for a 6-week double-blind, placebo-controlled clinical trial. Each patient filled the Conners' Adult ADHD Rating Scales-Self-Report-Screening version (CAARS before starting to take medication and in weeks 3 and 6 of the study. The mean score of the two groups receiving bupropion or placebo decreased over the 6 weeks. There was a significant difference between the two groups in CAARS score after 6 weeks. Bupropion is more effective than placebo in the treatment of adults with ADHD. Bupropion can be an alternative medication for the treatment of Adults with ADHD as its clinical efficacy was proven by other studies.

  8. 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.

  9. 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

  10. Causes of visual impairment and blindness in children in three ecological regions of Nepal: Nepal Pediatric Ocular Diseases Study

    Directory of Open Access Journals (Sweden)

    Adhikari S

    2015-08-01

    Full Text Available Srijana Adhikari,1 Mohan K Shrestha,1 Kamala Adhikari,2 Nhukesh Maharjan,1 Ujjowala D Shrestha1 1Pediatric Ophthalmology unit, Tilganaga Institute of Ophthalmology, Gaushala, Kathmandu, Nepal; 2Private consultant, Kathmandu, Nepal Purpose: To study the causes of blindness and visual impairment in children in three ecologically diverse regions of Nepal.Materials and methods: This is a baseline survey report of a 3-year longitudinal population-based study. One district each from the three ecological regions – Terai, Hills, and Mountains – was selected for the study. Village Development Committees from each district were selected by random sampling. Three community health workers were given training on vision screening and identification of abnormal ocular conditions in children. Health workers who examined children and collected data using pretested questionnaire performed house-to-house surveys. Children with abnormal vision or ocular conditions were referred to and examined by pediatric ophthalmologists.Results: A total of 10,950 children aged 0–10 years, 5,403 from Terai, 3,204 from Hills, and 2,343 from Mountains, were enrolled in the study. Of them, 681 (6.2% were nonresponders. The ratio of boys to girls was 1.03:1. Prevalence of blindness was 0.068% (95% confidence interval [CI] 0.02%–0.12% and visual impairment was 0.097% (95% CI 0.04%–0.15%. Blindness was relatively more prevalent in Terai region (0.08%, 95% CI 0.02%–0.13%. The most common cause of blindness was amblyopia (42.9% followed by congenital cataract. Corneal opacity (39% was the most common cause of unilateral blindness.Conclusion: More than two-thirds of the causes that lead to blindness and visual impairment were potentially preventable. Further, nutritional and genetic studies are needed to determine the factors associated with ocular morbidity and blindness in these regions. Keywords: vision screening, ocular morbidity, childhood, Nepal, pediatric

  11. Postoperative morbidity and histopathologic characteristics of tonsillar tissue following coblation tonsillectomy in children: a prospective randomized single-blind study.

    Science.gov (United States)

    Roje, Zeljka; Racić, Goran; Dogas, Zoran; Pisac, Valdi Pesutić; Timms, Michael

    2009-03-01

    The aim of this prospective randomized single blind study was to determine the depth of thermal damage to tonsillar tissue due to coblation, and to compare it with thermal damage to tonsillar tissue following conventional tonsillectomy; to correlate the depth of thermal damage to tonsillar tissue with the parameters of postoperative morbidity, to compare intraoperative blood loss, postoperative pain severity, time to resuming normal physical activity, and incidence of postoperative bleeding between two groups of tonsillectomized children aged up to 16 years. 72 children aged 3-16 years scheduled for tonsillectomy randomly assigned into two groups submitted either to conventional tonsillectomy with bipolar diathermy coagulation or to coblation tonsillectomy, with a 14-day follow up. Statistically significant differences were observed in the depth of thermal damage to tonsillar tissue (p < 0.001), intraoperative blood loss (p < 0.004), in postoperative pain severity (p < 0.05) and in time to resuming normal physical activity between the two groups (p < 0.001). There was no case of reactionary or secondary bleeding in either group. In this paper for the first time we have correlated postoperative morbidity and thermal tissue damage: less thermal damage is associated with less postoperative morbidity.

  12. 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.

  13. 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.

  14. Effect of diathermy on pain and healing in tonsillectomy, compared with other methods of haemostasis: a randomised study

    DEFF Research Database (Denmark)

    Hahn, C.H.; Rungby, J.A.; Overgaard, T.

    2008-01-01

    Objective:To compare three methods of haemostasis used for 'cold steel' tonsillectomy, in terms of pain scores and morbidity.Method and material:Prospective, randomised, single-blinded, controlled clinical study. Three haemostasis methods were compared: compression of the tonsillar fossae...

  15. Blind Masseurs

    Institute of Scientific and Technical Information of China (English)

    1997-01-01

    Guan Enming and his wife Hao Dejuan, a blind couple, vowed to "never become a burden for society." The couple retired from the QJngdao Massotherapy Hospital in 1992, and thereafter opened a private clinic with assistance from their

  16. The effects of captopril vs atenolol on memory, information processing and mood: a double-blind crossover study.

    OpenAIRE

    Deary, I J; Capewell, S; Hajducka, C; Muir, A.L

    1991-01-01

    1. Measures of memory, information processing ability, mood states and trait anxiety were estimated in a double-blind, double-dummy, randomised cross-over trial which compared the effects of atenolol (50 or 100 mg once daily) and captopril (25 or 50 mg twice daily), each taken for 6 weeks. Eighteen patients with mild to moderately severe hypertension were included. 2. There were no significant differences in systolic or diastolic blood pressure reduction between the two drugs. Pulse rate was ...

  17. Efficacy and safety of drotaverine hydrochloride in irritable bowel syndrome: A randomized double-blind placebo-controlled study

    OpenAIRE

    Ramesh R Rai; Manisha Dwivedi; Nirmal Kumar

    2014-01-01

    Backgrounds/Aims: To study the efficacy and safety of drotaverine hydrochloride (HCl) 80 mg tablet given thrice a day in the symptomatic relief of patients with irritable bowel syndrome (IBS). Patients and Methods: The study was a multicentric, randomized, double-blind, placebo-controlled parallel group study performed at three centers. The patients who fulfilled Rome II Criteria of IBS were included in the study. A total of 180 patients with IBS were randomized to drotaverine and placebo tre...

  18. Effectiveness of dry needling for the treatment of temporomandibular myofascial pain: a double-blind, randomized, placebo controlled study.

    Science.gov (United States)

    Dıraçoğlu, Demirhan; Vural, Meltem; Karan, Ayşe; Aksoy, Cihan

    2012-01-01

    To test the hypothesis that dry needling is more effective than sham dry needling in relieving myofascial pain of the temporomandibular muscles. Fifty-two subjects with established myofascial trigger points were randomized into two groups; study group (N: 26) and placebo group (N: 26). Dry needling was applied using acupuncture needles. Sham dry needling was applied to the placebo group. Pain pressure threshold was measured with pressure algometry, pain intensity was rated using a 10-cm visual analog scale (VAS) and the unassisted jaw opening without pain measurement was performed. Evaluations were done by a physician blinded to the data. Of 52 patients assigned, 50 completed the study. Mean algometric values were significantly higher in the study group when compared to the placebo group (p values being less than 0.05). There were no differences between the two groups in terms of VAS and unassisted jaw-opening without pain values. Dry needling appears to be an effective treatment method in relieving the pain and tenderness of myofascial trigger points.

  19. Effects of far-infrared irradiation on myofascial neck pain: a randomized, double-blind, placebo-controlled pilot study.

    Science.gov (United States)

    Lai, Chien-Hung; Leung, Ting-Kai; Peng, Chih-Wei; Chang, Kwang-Hwa; Lai, Ming-Jun; Lai, Wen-Fu; Chen, Shih-Ching

    2014-02-01

    The objective of this study was to determine the relative efficacy of irradiation using a device containing a far-infrared emitting ceramic powder (cFIR) for the management of chronic myofascial neck pain compared with a control treatment. This was a randomized, double-blind, placebo-controlled pilot study. The study comprised 48 patients with chronic, myofascial neck pain. Patients were randomly assigned to the experimental group or the control (sham-treatment) group. The patients in the experimental group wore a cFIR neck device for 1 week, and the control group wore an inert neck device for 1 week. Quantitative measurements based on a visual analogue scale (VAS) scoring of pain, a sleep quality assessment, pressure-pain threshold (PPT) testing, muscle tone and compliance analysis, and skin temperature analysis were obtained. Both the experimental and control groups demonstrated significant improvement in pain scores. However, no statistically significant difference in the pain scores was observed between the experimental and control groups. Significant decreases in muscle stiffness in the upper regions of the trapezius muscles were reported in the experimental group after 1 week of treatment. Short-term treatment using the cFIR neck device partly reduced muscle stiffness. Although the differences in the VAS and PPT scores for the experimental and control groups were not statistically significant, the improvement in muscle stiffness in the experimental group warrants further investigation of the long-term effects of cFIR treatment for pain management.

  20. Comparison of the efficacy of topical 1% lindane vs 5% permethrin in scabies: A randomized, double-blind study

    Directory of Open Access Journals (Sweden)

    Zargari Omid

    2006-01-01

    Full Text Available Background: Permethrin, a pyrethroid insecticide, is not yet available in Iran and may be a useful substitute for the control of scabies in Iran. Aim: To compare the efficacy of topical lindane with topical permethrin in the treatment of scabies in a population in Iran. Methods: In a double-blind, randomized study, all consecutive patients with scabies were randomized into two groups. One group and their family contacts received 1% lindane cream, and the other group and their family contacts were treated with topical 5% permethrin cream. Subsequently, patients were followed up at 2- and 4-week post-treatment. Results: Of the 99 patients enrolled in the study, 47 patients received 1% lindane cream, and 52 patients were treated topically with 5% permethrin cream. Permethrin provided an improvement rate of 84.6% after two weeks, whereas lindane was effective only in 48.9% of patients. Conclusion: Permethrin (5% cream was found to be significantly more effective in the treatment of scabies in comparison with lindane in this study, and it seems that it could be an alternative treatment.

  1. Effect of Brazilian green propolis in patients with type 2 diabetes: A double-blind randomized placebo-controlled study

    Science.gov (United States)

    FUKUDA, TAKUYA; FUKUI, MICHIAKI; TANAKA, MUHEI; SENMARU, TAKAFUMI; IWASE, HIROYA; YAMAZAKI, MASAHIRO; AOI, WATARU; INUI, TOSHIO; NAKAMURA, NAOTO; MARUNAKA, YOSHINORI

    2015-01-01

    Propolis contains a variety of chemical compounds, including polyphenols, flavonoids, phenolic aldehydes, amino acids and vitamins, and presents numerous biological and pharmacological properties. The aim of the present study was to evaluate the effect of propolis on blood examination data in patients with type 2 diabetes. In the double-blind, 8-week randomized controlled study, 80 patients with type 2 diabetes were enrolled. Patients were randomly assigned to receive Brazilian green propolis (226.8 mg/day for 8 weeks) (n=41) or the placebo (n=39). The primary endpoint was to detect changes in blood examination data associated with metabolic disorders in patients suffering from diabetes mellitus, including the homeostasis model assessment of insulin resistance (HOMA-IR), uric acid and estimated glomerular filtration rate (eGFR) from baseline to the end of this study. The value of HOMA-IR was not significantly changed by the 8-week administration of propolis or placebo from the baseline data. Values of blood uric acid and eGFR in patients taking the placebo became worse at 8 weeks compared to the baseline, whereas this did not occur in patients consuming Brazilian green propolis. However, HOMA-IR was not improved by propolis intake. A randomized, controlled 8-week trial suggests that Brazilian green propolis (226.8 mg/day) prevents patients with type 2 diabetes from developing worse blood uric acid and eGFR. PMID:26137235

  2. Lithium in the Acute Treatment of Bipolar I Disorder: A Double-Blind, Placebo-Controlled Study.

    Science.gov (United States)

    Findling, Robert L; Robb, Adelaide; McNamara, Nora K; Pavuluri, Mani N; Kafantaris, Vivian; Scheffer, Russell; Frazier, Jean A; Rynn, Moira; DelBello, Melissa; Kowatch, Robert A; Rowles, Brieana M; Lingler, Jacqui; Martz, Karen; Anand, Ravinder; Clemons, Traci E; Taylor-Zapata, Perdita

    2015-11-01

    Lithium is a benchmark treatment for bipolar disorder in adults. Definitive studies of lithium in pediatric bipolar I disorder (BP-I) are lacking. This multicenter, randomized, double-blind, placebo-controlled study of pediatric participants (ages 7-17 years) with BP-I/manic or mixed episodes compared lithium (n = 53) versus placebo (n = 28) for up to 8 weeks. The a priori primary efficacy measure was change from baseline to the end of study (week 8/ET) in the Young Mania Rating Scale (YMRS) score, based on last-observation-carried-forward analysis. The change in YMRS score was significantly larger in lithium-treated participants (5.51 [95% confidence interval: 0.51 to 10.50]) after adjustment for baseline YMRS score, age group, weight group, gender, and study site (P = .03). Overall Clinical Global Impression-Improvement scores favored lithium (n = 25; 47% very much/much improved) compared with placebo (n = 6; 21% very much/much improved) at week 8/ET (P = .03). A statistically significant increase in thyrotropin concentration was seen with lithium (3.0 ± 3.1 mIU/L) compared with placebo (-0.1 ± 0.9 mIU/L; P Lithium was superior to placebo in reducing manic symptoms in pediatric patients treated for BP-I in this clinical trial. Lithium was generally well tolerated in this patient population and was not associated with weight gain, distinguishing it from other agents commonly used to treat youth with bipolar disorder. Copyright © 2015 by the American Academy of Pediatrics.

  3. 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.

  4. 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.

  5. 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 stretching groups were observed (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.

  6. 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 Anti-Aging Formula.

    Science.gov (United States)

    Goldberg, Lawrence D; Crysler, Corina

    2014-01-01

    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. 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. 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. 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%). The study suggests GAAF in combination with TAZ is safe and provides significant clinical benefit with relative improvement in facial fine wrinkling, overall photodamage, skin moisture and

  7. 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

  8. A comparative double-blind randomized trial of activated protein C and unfractionated heparin in the treatment of disseminated intravascular coagulation.

    Science.gov (United States)

    Aoki, Nobuo; Matsuda, Tamotsu; Saito, Hidehiko; Takatsuki, Kiyoshi; Okajima, Kenji; Takahashi, Hoyu; Takamatsu, Junki; Asakura, Hidesaku; Ogawa, Nobuya

    2002-06-01

    A randomized prospective double-blind trial was performed to compare the safety and efficacy of human activated protein C (APC) and unfractionated heparin for the treatment of disseminated intravascular coagulation (DIC). One hundred thirty-two patients with DIC were enrolled in this study: 63 patients received APC (12.5 U [2.5 microg]/kg body wt per hour) and 69 patients received heparin (8 U/kg body wt per hour) by intravenous infusion for 6 days. Forty-nine APC-treated patients and 55 heparin-treated patients were evaluated for efficacy, and 52 APC-treated patients and 55 heparin-treated patients were evaluated for safety. The 2 groups were similar with respect to sex, age, body weight, underlying diseases, and coagulation/fibrinolysis parameters before treatment. Aggravation of bleeding was seen after treatment in 8 patients receiving heparin, but in none of the patients receiving APC. The number of patients who showed alleviation of bleeding was significantly higher in the APC group than the heparin group (P = .009). The effects on DIC-related organ dysfunction were not significantly different between the 2 groups. Fibrinogen-fibrin degradation products, D-dimer, thrombin-antithrombin complex (TAT), and plasmin-plasmin inhibitor complex (PIC) were all significantly decreased by treatment in both groups. Fibrinogen, protein C, and antithrombin were significantly increased in the APC group, whereas only protein C was significantly increased in the heparin group. Platelet count in the nonleukemic group was significantly increased in those patients receiving APC but not increased in those patients receiving heparin. Improvement of coagulation/fibrinolysis was assessed by scoring 4 parameters (soluble fibrin monomers, D-dimer, TAT, and PIC), and the results indicated that the APC group showed significantly greater improvement than the heparin group (P = .046). There was, however, no significant difference in the rate of complete recovery from DIC between the 2

  9. Static analysis for blinding

    DEFF Research Database (Denmark)

    Nielsen, Christoffer Rosenkilde; Nielson, Hanne Riis

    2006-01-01

    operation blinding. In this paper we study the theoretical foundations for one of the successful approaches to validating cryptographic protocols and we extend it to handle the blinding primitive. Our static analysis approach is based on Flow Logic; this gives us a clean separation between the specification...... of the analysis and its realisation in an automatic tool. We concentrate on the former in the present paper and provide the semantic foundation for our analysis of protocols using blinding - also in the presence of malicious attackers....

  10. 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

    2010-01-01

    Background “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. Objectives 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. Methods 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. Results 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. Conclusions 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. PMID:20075020

  11. The effect of Breezy candy on halitosis: a double-blind, controlled, and randomized study.

    Science.gov (United States)

    Barak, Shlomo; Katz, Joseph

    2012-04-01

    Halitosis (bad breath) is a common condition that is socially crippling for vast parts of the population and results from malodorous volatile sulfur compounds, which are by-products of oral bacteria. In this doubled-blind, randomized study, 75 subjects with halitosis were evaluated. The participants were treated with or without abrasive microcapsules (candy) containing zinc gluconate 0.5%, propolis 2%, and a combination of both (zinc 0.25% and propolis 1%). The halitosis was assessed by a Halimeter, a portable instrument that measures the emission of volatile sulfur compounds at different time exposures to the treatments. Breezy candy (which is sugar-free) was found effective in the treatment of halitosis for up to 4 hours. While treatment with regular candy (group 1, traditional candy without abrasive particles) showed reduction in malodor of 10%, Breezy candy showed reduction of up to 60% in malodor (P halitosis. The combined effect of abrasion by microcapsules with zinc supplement represents a novel and successful approach for the treatment of halitosis.

  12. Studies on the cranial osteology of the blind catfish Horoglanis krishnai Menon (Pisces, Clariidae.

    Directory of Open Access Journals (Sweden)

    Mercy T.V. Anna

    2001-01-01

    Full Text Available Horaglanis krishnai Menon is a blind catfish inhabiting the dug- out wells at Kottayam, Kerala, South India. Studies on the cranial osteology of the fish show that the bones on the skull are firmly articulated. The frontoparietal fontanella is very large so that the cranium virtually lacks a roof. The sphenotics and alisphenoids are hardly recognizable and the orbital bones are entirely lacking. In osteological features H. krishnai closely resembles Uegitglanis zammaroni. But in H. krishnai the orbital bones are further reduced or even absent. The fontanella is larger than that of any other known catfish. These two species must have evolved from the same ancester and have taken up nearly identical ways of life. The difference between the skeletons of these two appears to be largely dependent on the relative size of the frontoparietal fontanella. Its greater development in H. krishnai brought about a suppression or reduction of some of the bones clearly visible in Uegitglanis. It would appear that the modification initiated in Uegitglanis gatered momentum in Horaglanis. These two fishes form a group distinct from clariids and bagrids but form a connecting link between the two.

  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. A double-blind, randomized, placebo-controlled study of nifedipine on early renal allograft function.

    Science.gov (United States)

    Wilkie, M E; Beer, J C; Evans, S J; Raftery, M J; Lord, R H; Moore, R; Marsh, F P

    1994-01-01

    A double-blind, randomized, placebo-controlled study was conducted to determine the effect of nifedipine on early renal allograft function when added to a triple therapy immunosuppression regime comprising low-dose cyclosporin (CsA), prednisolone and azathioprine. Fifty adult cadaveric renal allograft recipients were randomized to placebo (group P n = 17), nifedipine 10 mg preoperatively and 20 mg b.d. postoperatively for 48 h, followed by matching placebo for 3 months (group NS n = 16) or nifedipine 10 mg preoperatively and 20 mg b.d. postoperatively for 3 months (group NL n = 17). Donor and recipient exclusion criteria included recent calcium antagonist treatment. At 3 months after transplantation mean GFR adjusted for graft loss was significantly higher in group NL than in NS (mean +/- SD 61 +/- 28 versus 34 +/- 25 ml/min/1.73 m2; P nifedipine commenced preoperatively and continued for 3 months following transplantation has beneficial effects on early renal allograft function when incorporated as part of an immunotherapy regimen based on cyclosporin.

  15. Lung ultrasound versus chest radiography for the diagnosis of pneumothorax in critically ill patients: A prospective, single-blind study

    Directory of Open Access Journals (Sweden)

    W Abdalla

    2016-01-01

    Full Text Available Background: Radiologic data remains the gold standard for the diagnosis of pneumothorax (PTX. The use of ultrasonography (US has recently emerged as the method of choice with physicians who can perform bedside US. Purpose: To compare the diagnostic accuracy of lung US against bedside chest radiography (CR for the detection of PTX using thoracic computed tomography (CT as the gold standard. Materials and Methods: We conducted a prospective, single-blind study on 192 critically ill patients; each patient received lung US examination, bedside CR, followed by thoracic CT scan searching for PTX. Results: Of the studied patients, CT of the chest confirmed the diagnosis of PTX in 36 (18.75% patients of which 31 were diagnosed by thoracic US while CR detected only 19 cases. Overall lung US showed a considerable higher sensitivity than bedside CR (86.1% vs. 52.7%, lung US also showed higher, negative predictive values, and diagnostic accuracy against CR (96.8% vs. 90.1%, and (95.3% vs. 90.6%, respectively. CR had a slightly higher specificity than lung US (99.4% vs. 97.4%, and higher positive predictive values (95.0% vs. 88.6%. Conclusion: Lung US is an accurate modality more than anteroposterior bedside CR in comparison with CT scanning when evaluating critically ill mechanically ventilated patients, patients underwent thoracocentesis, central venous catheter insertion, or patients with polytrauma.

  16. Safety and effectiveness of autoinoculation therapy in cutaneous warts: a double--blind, randomized, placebo--controlled study.

    Science.gov (United States)

    Lal, Niharika Ranjan; Sil, Amrita; Gayen, Tirthankar; Bandyopadhyay, Debabrata; Das, Nilay Kanti

    2014-01-01

    In spite of the availability of multiple treatment options, viral warts are known for their persistence and recurrence, causing frustration to patients and treating physicians. To study the effectiveness and safety of autoinoculation as a treatment modality in cutaneous warts. A double-blind, placebo-controlled study was carried out. In the treatment group, full-thickness warty tissue was excised, minced and implanted in a small dermal pocket. In the control group, warty tissue was only excised and not implanted, though a dermal pocket was made. Patients were evaluated every four weeks with lesion counts. The procedure was repeated at 4 and 8 weeks. Response was assessed at each visit and at 12 weeks. Forty-eight patients with cutaneous warts (male: female=32:16) were randomized into autoinoculation and control groups. The number of warts at baseline was comparable in both groups (P=0.293). Reduction in the number of warts was significantly more in the autoinoculation group (8.50±13.88) than in the control group (10.04±5.80) from 8 weeks onwards (P=0.010). Complete resolution occurred only in the autoinoculation group, in 62.5% of cases. Adverse effects were seen in 11 patients, including infection of the donor site (5 cases), keloid formation (3) and hypopigmentation (3). Autoinoculation may be an effective therapeutic modality for cutaneous warts and two sessions may be required for optimum results.

  17. 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.

  18. Topical Colchicine Gel versus Diclofenac Sodium Gel for the Treatment of Actinic Keratoses: A Randomized, Double-Blind Study

    Science.gov (United States)

    Faghihi, Gita; 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. PMID:27689135

  19. Efficacy of topical chamomile management vs. placebo in patients with oral lichen planus: a randomized double-blind study.

    Science.gov (United States)

    Lopez Jornet, P; Aznar-Cayuela, C

    2016-10-01

    The purpose of this study was to compare the clinical therapeutic efficacy of topical applications of chamomile vs. a placebo for treating oral lichen planus (OLP). This double-blind study, randomly divided 60 patients with OLP into two groups, 30 treated with 2% Chamaemelum nobile gel (0.5 mL/3 times a day) and 30 treated with a placebo (Trial Registration NCT02421770). A visual analogue scale was used to rate pain, itching and burning sensation, and Thongprasom Index, the Oral Health Impact Profile 14 (OHIP-14) and the Hospital Anxiety-Depression Scale. Patients were evaluated at baseline and after 4 weeks of treatment. Patients treated with chamomile showed significant improvements after 4 weeks for pain (P < 0.001), burning sensation (P < 0.001), itching (P = 0.011), OHIP-14 (P < 0.001) and Thongprasom index (P = 0.001); 92% of patients treated with chamomile showed a partial or total response, while only five subjects (17%) in the placebo group showed any improvement. The topical application of 2% chamomile gel is an effective treatment for OLP. © 2016 European Academy of Dermatology and Venereology.

  20. Postoperative Etoricoxib versus Ketoprofen Administration for Pain Management after Total Knee Arthroplasty: A Randomized, Double-Blind Controlled Study

    Directory of Open Access Journals (Sweden)

    Simona Cionac Florescu

    2015-01-01

    Full Text Available Objective. This randomized double-blind study compared the analgesic efficacy and tolerability of etoricoxib versus ketoprofen in 165 patients with elective total primary knee arthroplasty. Methods. After ethical committee approval, 165 patients were randomized in 3 groups: the etoricoxib group (E receiving etoricoxib 120 mg/day, at the end of surgery and in the first postoperative day; the ketoprofen group (K receiving ketoprofen 2 pills of 100 mg/day, the first at the end of surgery and then 1 pill every 12 hours in the surgery day and the first postoperative day; the placebo group (P. All groups received postoperatively the same analgesia protocol when NRS is over 3 with IV Perfalgan and morphine. The effectiveness was evaluated by the time from the initiation of spinal anesthesia until the first analgesic dose, the total amount of morphine administered in the surgery day and the first postoperative day, and the frequency of patients with side effects and necessary amount of adjuvant medication. Results. The baseline demographic characteristics were similar among the 3 groups. In both study days etoricoxib provided an analgesic effect superior to placebo and to ketoprofen, the total administered morphine being significantly lower in etoricoxib group. There were no statistically significant differences between groups regarding the side effects.

  1. A Randomized, Double-blind, Placebo-Controlled Study of Efficacy of Oral Acyclovir in the Treatment of Pityriasis Rosea.

    Science.gov (United States)

    Ganguly, Satyaki

    2014-05-01

    Pityriasis rosea is an acute self-limiting skin disorder of unknown aetiology. Recently human herpes virus 6 and 7 has been hypothesized to be the cause of pityriasis rosea. To determine the efficacy of acyclovir, an anti-viral drug, in the treatment of pityriasis rosea. A randomized, double-blind, placebo-controlled study of efficacy of oral acyclovir in the treatment of pityriasis rosea was conducted on 73 patients. Thirty eight randomly selected patients were started on oral acyclovir. Thirty-five patients were prescribed placebo. The patients as well as the chief investigator were unaware of the therapeutic group to which patients belonged (acyclovir or placebo). Patients in both the groups were evaluated clinically after 7 and 14 days following the first visit and the data were analysed. Follow up data of 60 patients was available and these were included in the statistical analysis. 53.33% and 86.66% of the patients belonging to the acyclovir group showed complete resolution on the 7(th) day and 14(th) day respectively following the first visit compared to 10% and 33.33% of patients from the placebo group. The findings were statistically significant. The study showed that high dose acyclovir is effective in the treatment of pityriasis rosea.

  2. Effect of Kinesiology Taping on Breast Cancer-Related Lymphedema: A Randomized Single-Blind Controlled Pilot Study

    Directory of Open Access Journals (Sweden)

    A. Smykla

    2013-01-01

    Full Text Available The aim of the study was to assess the efficacy of Kinesiology Taping (KT for treating breast cancer-related lymphedema. Sixty-five women with unilateral stage II and III lymphedema were randomly grouped into the KT group (K-tapes, n=20, the Quasi KT group (quasi K-tapes, n=22, or the MCT group (multilayered compression therapy group, n=23. Skin care, 45 min pneumatic compression therapy, 1 h manual lymphatic drainage, and application of K-tape/Quasi K-tapes/multilayered short-stretch bandages were given every treatment session, 3 times per week for 1 month. Patient evaluation items included limb size and percentage edema. Comparing the changes in K-tapes with quasi K-tapes changes, there were no significant differences (P>0.05. The edema reduction of multilayered bandages was much better than in results observed in taping groups. The KT appeared to be ineffective at secondary lymphedema after breast cancer treatment. The single-blind, controlled pilot study results suggest that K-tape could not replace the bandage, and at this moment it must not be an alternative choice for the breast cancer-related lymphedema patient. The trial is registered with ACTRN12613001173785.

  3. Hypnosis for reduction of background pain and pain anxiety in men with burns: A blinded, randomised, placebo-controlled study.

    Science.gov (United States)

    Jafarizadeh, Hossein; Lotfi, Mojgan; Ajoudani, Fardin; Kiani, Arezou; Alinejad, Vahid

    2017-08-08

    'Background pain' and 'pain anxiety' are among the numerous problems of patients with burns. Non-pharmacological and pharmacological interventions have been used to reduce background pain and pain anxiety. This study compared the effectiveness of hypnosis and 'neutral hypnosis' (as a placebo in the control group) in decreasing the background burn pain and pain anxiety of adult male survivors with burns. This is a blinded, randomised, placebo-controlled study. Sixty men with burns were included in the minimisation method (30 individuals in the intervention group and 30 individuals in the control group). Four hypnotherapy sessions were performed every other day for each participant in the intervention group. Four neutral hypnosis sessions were performed every other day in the control group. Burn pain and pain anxiety of the patients in both groups were measured at the end of the second and fourth sessions. Repeated measures ANOVA was used for data analysis. There was no significant difference between the groups in the reduction in background pain intensity. There was a significant reduction in background pain quality and pain anxiety in the intervention group during the four hypnosis sessions. After two hypnotherapy sessions, a significant reduction was observed in the level of background pain quality and pain anxiety of participants. Hypnosis is effective in reducing background pain quality and pain anxiety of men with burns. Copyright © 2017 Elsevier Ltd and ISBI. All rights reserved.

  4. Comparison of the anesthetic efficacy of articaine and mepivacaine in pediatric patients: a randomized, double-blind study.

    Science.gov (United States)

    Odabaş, Mesut Enes; Cınar, Cagdas; Deveci, Ceren; Alaçam, Alev

    2012-01-01

    The purpose of this study was to evaluate and compare the reaction to pain during local injection and duration of numbness of soft tissue with 4% articaine or 3% mepivacaine in children. A randomized, double-blind, split-mouth study was used with a sample of 50 7- to 13-year-old children (25 boys and 25 girls; mean age=11.3 years old) that had similar operative procedure needs in symmetric primary teeth. The modified behavioral pain scale was used for objective evaluation of the children. The sensation after injection and treatment was evaluated using the Wong-Baker FACES pain rating scale. Parents were instructed to ask the child and to record the time when feeling of numbness disappeared. The duration of soft tissue was longer for articaine (140.69 ± 49.76 minutes) than for mepivacaine (117.52 ± 42.99 minutes). No difference regarding efficacy of the anesthesia was observed. No statistically significant difference was found in blood pressure, heart rate, or oxygen saturation in all evaluation periods for both solutions. The feeling after treatment was similar for the 2 solutions. Four percent articaine with 1:200,000 and 3% mepivacaine presented the same efficacy, and children displayed the same behavior during injection.

  5. Effect of Kinesiology Taping on breast cancer-related lymphedema: a randomized single-blind controlled pilot study.

    Science.gov (United States)

    Smykla, A; Walewicz, K; Trybulski, R; Halski, T; Kucharzewski, M; Kucio, C; Mikusek, W; Klakla, K; Taradaj, J

    2013-01-01

    The aim of the study was to assess the efficacy of Kinesiology Taping (KT) for treating breast cancer-related lymphedema. Sixty-five women with unilateral stage II and III lymphedema were randomly grouped into the KT group (K-tapes, n = 20), the Quasi KT group (quasi K-tapes, n = 22), or the MCT group (multilayered compression therapy group, n = 23). Skin care, 45 min pneumatic compression therapy, 1 h manual lymphatic drainage, and application of K-tape/Quasi K-tapes/multilayered short-stretch bandages were given every treatment session, 3 times per week for 1 month. Patient evaluation items included limb size and percentage edema. Comparing the changes in K-tapes with quasi K-tapes changes, there were no significant differences (P > 0.05). The edema reduction of multilayered bandages was much better than in results observed in taping groups. The KT appeared to be ineffective at secondary lymphedema after breast cancer treatment. The single-blind, controlled pilot study results suggest that K-tape could not replace the bandage, and at this moment it must not be an alternative choice for the breast cancer-related lymphedema patient. The trial is registered with ACTRN12613001173785.

  6. 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

  7. Astyanax mexicanus, the Blind Mexican Cave Fish: A Model for Studies in Development and Morphology.

    Science.gov (United States)

    Borowsky, Richard

    2008-11-01

    INTRODUCTIONThe perpetual darkness of caves has two important consequences for permanent inhabitants. First, eyes and pigmentation lose their primary functions. Second, in the absence of photosynthesis, food is rare. For these reasons, cave-adapted species typically have reduced eyes and pigmentation and increased or more efficient metabolisms. Additionally, other senses are usually augmented to compensate for the loss of vision. Identifying the genetic bases underlying these phenotypic changes will enhance our understanding of the specific pathways involved in control of these phenotypes and, in general, the evolutionary process. Unfortunately, the genetics of most cave animals cannot be studied because they are not easily bred. Blind Mexican tetras, Astyanax mexicanus, are the valuable exception to this rule because fish from the various cave populations are fully interfertile with one another and with eyed sister forms still living in nearby surface streams. Hybrids between surface and cave forms permit genetic analysis of their differences, and study of the pure forms as well as of hybrids allows study of their developmental differences. Quantitative trait loci (QTL) analysis has already identified some specific genes responsible for differences between cave and surface forms as well as other likely candidates; more will be added in the future. This system is a valuable addition to the array of existing models for the study of developmental and evolutionary genetics because cave populations are repositories of numerous naturally occurring mutations affecting development of the eyes and other senses, pigmentation, bone structure, metamerism, and metabolism. These alleles have been prescreened by natural selection for high viability, which simplifies their study. In contrast, new alleles obtained through mutagenesis in other model species are typically burdened with lower viability.

  8. 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

    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 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. PMID:27980393

  9. 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.

  10. A Comparative Study of Whitman and Frost

    Institute of Scientific and Technical Information of China (English)

    田寨耕

    2014-01-01

    Walt Whitman and Robert Frost are both famous poets in American literary history. They share a great deal in common. This paper attempts to make a study of the two poets by means of comparing their similarities and differences.

  11. Omega-3 fatty acids modify human cortical visual processing--a double-blind, crossover study.

    Science.gov (United States)

    Bauer, Isabelle; Crewther, David P; Pipingas, Andrew; Rowsell, Renee; Cockerell, Robyn; Crewther, Sheila G

    2011-01-01

    While cardiovascular and mood benefits of dietary omega-3 fatty acids such as docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) are manifest, direct neurophysiological evidence of their effects on cortical activity is still limited. Hence we chose to examine the effects of two proprietary fish oil products with different EPA:DHA ratios (EPA-rich, high EPA:DHA; DHA-rich) on mental processing speed and visual evoked brain activity. We proposed that nonlinear multifocal visual evoked potentials (mfVEP) would be sensitive to any alteration of the neural function induced by omega-3 fatty acid supplementation, because the higher order kernel responses directly measure the degree of recovery of the neural system as a function of time following stimulation. Twenty-two healthy participants aged 18-34, with no known neurological or psychiatric disorder and not currently taking any nutritional supplementation, were recruited. A double-blind, crossover design was utilized, including a 30-day washout period, between two 30-day supplementation periods of the EPA-rich and DHA-rich diets (with order of diet randomized). Psychophysical choice reaction times and multi-focal nonlinear visual evoked potential (VEP) testing were performed at baseline (No Diet), and after each supplementation period. Following the EPA-rich supplementation, for stimulation at high luminance contrast, a significant reduction in the amplitude of the first slice of the second order VEP kernel response, previously related to activation in the magnocellular pathway, was observed. The correlations between the amplitude changes of short latency second and first order components were significantly different for the two supplementations. Significantly faster choice reaction times were observed psychophysically (compared with baseline performance) under the EPA-rich (but not DHA-rich) supplementation, while simple reaction times were not affected. The reduced nonlinearities observed under the EPA

  12. Omega-3 fatty acids modify human cortical visual processing--a double-blind, crossover study.

    Directory of Open Access Journals (Sweden)

    Isabelle Bauer

    Full Text Available While cardiovascular and mood benefits of dietary omega-3 fatty acids such as docosahexaenoic acid (DHA and eicosapentaenoic acid (EPA are manifest, direct neurophysiological evidence of their effects on cortical activity is still limited. Hence we chose to examine the effects of two proprietary fish oil products with different EPA:DHA ratios (EPA-rich, high EPA:DHA; DHA-rich on mental processing speed and visual evoked brain activity. We proposed that nonlinear multifocal visual evoked potentials (mfVEP would be sensitive to any alteration of the neural function induced by omega-3 fatty acid supplementation, because the higher order kernel responses directly measure the degree of recovery of the neural system as a function of time following stimulation. Twenty-two healthy participants aged 18-34, with no known neurological or psychiatric disorder and not currently taking any nutritional supplementation, were recruited. A double-blind, crossover design was utilized, including a 30-day washout period, between two 30-day supplementation periods of the EPA-rich and DHA-rich diets (with order of diet randomized. Psychophysical choice reaction times and multi-focal nonlinear visual evoked potential (VEP testing were performed at baseline (No Diet, and after each supplementation period. Following the EPA-rich supplementation, for stimulation at high luminance contrast, a significant reduction in the amplitude of the first slice of the second order VEP kernel response, previously related to activation in the magnocellular pathway, was observed. The correlations between the amplitude changes of short latency second and first order components were significantly different for the two supplementations. Significantly faster choice reaction times were observed psychophysically (compared with baseline performance under the EPA-rich (but not DHA-rich supplementation, while simple reaction times were not affected. The reduced nonlinearities observed under the

  13. Effects of dopaminergic modulation on automatic semantic priming: a double-blind study.

    Science.gov (United States)

    Andreou, Christina; Veith, Kristina; Bozikas, Vasilis P; Lincoln, Tania M; Moritz, Steffen

    2014-03-01

    Enhanced automatic spreading of activation in the semantic network has been suggested to underlie formal thought disorder in patients with schizophrenia, but it is not clear how this relates to the dopaminergic dysfunction implicated in the disorder. Previous studies on dopaminergic modulation of priming in healthy volunteers have focused on controlled rather than automatic processes. The present study aimed to examine the effects of both a dopaminergic agonist and a dopaminergic antagonist on semantic priming while minimizing the contribution of controlled processes. We investigated the effects of levodopa (L-Dopa; 100 mg), haloperidol (2 mg) and placebo on priming in healthy participants within a randomized, double-blind, crossover design. We used a pronunciation priming task with word triplets; the middle word was an ambiguous word, whereas the first word of the triplet served to provide either a congruent, incongruent or unbiased context for the target word. Two stimulus onset asynchronies (SOA) were used: 150 ms and 750 ms. The study involved 34 participants. At an SOA of 150 ms, L-Dopa accelerated responses to incongruent targets and subordinate targets of ambiguous words, whereas haloperidol was associated with faster responses in congruent contexts and dominant targets. At an SOA of 750 ms, haloperidol accelerated responses to subordinate targets. Modulations in the relative magnitude of priming according to substance and condition rather than absolute priming were assessed. Effects of L-Dopa on automatic priming processes appear to be different than those on controlled processes. Our results are consistent with those of studies on semantic priming and the effects on antipsychotics in patients with schizophrenia.

  14. 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.

  15. CURRICULAR OFFER INFLUENCING STUDENTS’ SATISFACTION: COMPARATIVE STUDY

    OpenAIRE

    Oana DUMITRASCU; Constantin Manuel HILA

    2014-01-01

    The main objective of the study is the determination of students’ satisfaction regarding curricular activities. The study has been accomplished using the qualitative and quantitative research, using the bibliographic study, various secondary sources and different primary sources. The study is developed with a marketing research and accomplished using the survey method. 699 students from four universities have been questioned. Due to a comparative study the University of Applied Sciences Worms...

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

    Directory of Open Access Journals (Sweden)

    Chambliss Walter

    2008-05-01

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

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

    Directory of Open Access Journals (Sweden)

    Jie Zhou

    2014-08-01

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

  18. 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....... Finally, pedagogical implication of CFL is discussed and future research is suggested. Keywords: error analysis, comparative sentences, comparative structure ‘‘bǐ - 比’, Chinese as a foreign language (CFL), written production...

  19. Ertapenem versus Ceftriaxone Followed by Appropriate Oral Therapy for Treatment of Complicated Urinary Tract Infections in Adults: Results of a Prospective, Randomized, Double-Blind Multicenter Study

    OpenAIRE

    Tomera, Kevin M.; Burdmann, Emmanuel A.; PAMO REYNA, OSCAR G.; Jiang, Qi; Wimmer, Wendy M.; Woods, Gail L.; Gesser, Richard M.

    2002-01-01

    The efficacy and safety of intravenous (i.v.) ertapenem (1 g once a day) with the option to switch to an oral agent for treatment of adults with complicated urinary tract infections (UTIs) were compared with that of i.v. ceftriaxone (1 g daily) with the same oral switch option in a multicenter, double-blind, prospective, randomized study. At entry, 592 patients were assigned to one of two strata: acute pyelonephritis or other complicated UTI without acute pyelonephritis. After a minimum of 3 ...

  20. Efficacy and safety of Myofascial-meridian Release Acupuncture (MMRA) for chronic neck pain: a study protocol for randomized, patient- and assessor-blinded, sham controlled trial

    OpenAIRE

    Lee, Seunghoon; Nam, Dongwoo; Leem, Jungtae; Han, Gajin; Lee, Seungmin; Lee,Junhee

    2016-01-01

    Background The purpose of this study is to evaluate the efficacy and safety of myofascial-meridian release acupuncture (MMRA) in the treatment of chronic neck pain compared with sham acupuncture. Methods/design A protocol for a randomized, patient- and assessor-blinded, sham controlled parallel trial is presented. Seventy-four participants with a ≥3 month history of neck pain and a score of ≥4 on the 11-point pain intensity numerical rating scale (PI-NRS) will be randomly assigned to the MMRA...

  1. 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.

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

    Directory of Open Access Journals (Sweden)

    Chambliss Walter

    2009-08-01

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

  3. Single dose metronidazole, tinidazole and ornidazole in the treatment of bacterial vaginosis - a comparative study

    OpenAIRE

    Banapura Ambika; Mamatha K. R.; Geetha Shivamurthy

    2016-01-01

    Background: Bacterial vaginosis (BV) is the most common cause of abnormal vaginal discharge. There is a lack of consensus on the etiologic agents or agents associated with BV, due to polymicrobial nature. There is high recurrence rate of BV and it is difficult to treat. Metronidazole is the drug of choice but newer nitroimidazoles are better alternatives with long half-lives and better tolerability. Methods: This was a prospective, comparative, randomized, single blinded study on 120 diagn...

  4. Case study: sleep and aggressive behavior in a blind, retarded adolescent. A concomitant schedule disorder?

    Science.gov (United States)

    Sadeh, A; Klitzke, M; Anders, T F; Acebo, C

    1995-06-01

    Blind people are prone to suffer from sleep-wake schedule disorders. This report describes 2 months of monitoring of sleep patterns and aggressive behaviors in a totally blind, severely retarded adolescent boy, hospitalized in a psychiatric hospital. The documented sleep-wake patterns seem to portray a sleep-wake schedule disorder with a monthly periodicity. Aggressive behaviors seem to echo the same periodicity, suggesting that a common or linked biobehavioral timing mechanism may underlie both sleep and episodic aggressive outbursts. The need to consider sleep schedule disorders as a primary process underlying some psychopathological disorders, and the related risks of misdiagnosis and mistreatment, are highlighted.

  5. Dexmedetomidine as an adjunct in postoperative analgesia following cardiac surgery: A randomized, double-blind study

    Directory of Open Access Journals (Sweden)

    Shio Priye

    2015-01-01

    Full Text Available Objectives: The purpose of this study was to determine analgesic efficacy of dexmedetomidine used as a continuous infusion without loading dose in postcardiac surgery patients. Settings and Design: A prospective, randomized, double-blind clinical study in a single tertiary care hospital on patients posted for elective cardiac surgery under cardiopulmonary bypass. Interventions: Sixty-four patients who underwent elective cardiac surgery under general anesthesia were shifted to intensive care unit (ICU and randomly divided into two groups. Group A (n = 32 received a 12 h infusion of normal saline and group B (n = 32 received a 12 h infusion of dexmedetomidine 0.4 μg/kg/h. Postoperative pain was managed with bolus intravenous fentanyl. Total fentanyl consumption, hemodynamic monitoring, Visual Analogue Scale (VAS pain ratings, Ramsay Sedation Scale were charted every 6 th hourly for 24 h postoperatively and followed-up till recovery from ICU. Student′s t-test, Chi-square/Fisher′s exact test has been used to find the significance of study parameters between the groups. Results: Dexmedetomidine treated patients had significantly less VAS score at each level (P < 0.001. Total fentanyl consumption in dexmedetomidine group was 128.13 ± 35.78 μg versus 201.56 ± 36.99 μg in saline group (P < 0.001. A statistically significant but clinically unimportant sedation was noted at 6 and 12 h (P < 0.001, and P = 0.046 respectively. Incidence of delirium was less in dexmedetomidine group (P = 0.086+. Hemodynamic parameters were statistically insignificant. Conclusions: Dexmedetomidine infusion even without loading dose provides safe, effective adjunct analgesia, reduces narcotic consumption, and showed a reduced trend of delirium incidence without undesirable hemodynamic effects in the cardiac surgery patients.

  6. 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.

  7. 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.

  8. 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.

  9. Clonidine premedication in patients with sleep apnea syndrome: a randomized, double-blind, placebo-controlled study.

    Science.gov (United States)

    Pawlik, Michael T; Hansen, Ernil; Waldhauser, Daniela; Selig, Christoph; Kuehnel, Thomas S

    2005-11-01

    Patients with sleep apnea often present with cardiac diseases and breathing difficulties, with a high risk of postoperative respiratory depression. We conducted a randomized, double-blind, prospective study in 30 adult patients with obstructive sleep apnea, undergoing elective ear-nose-throat surgery. The patients were randomly assigned to receive placebo or clonidine (2 microg/kg oral) the night before and the next morning 2 h before surgery. Spo2, heart rate, mean arterial blood pressure, snoring, and oronasal airflow were monitored for 36 h. A standard anesthesia was used consisting of propofol and remifentanil. Anesthetic drug consumption, postoperative analgesics, and pain score were recorded. In the clonidine group, mean arterial blood pressures were significantly lower during induction, operation, and emergence from anesthesia. Both propofol dose required for induction (190 +/- 32.2 mg) and anesthesia (6.3 +/- 1.3 mg . kg(-1).h(-1)) during surgery were significantly reduced in the clonidine group compared with the placebo group (induction 218 +/- 32.4, anesthesia 7.70 +/- 1.5; P clonidine group. Apnea and desaturation index were not different between the groups, whereas the minimal postoperative oxygen saturation on the day of surgery was significantly lower in the placebo than in the clonidine group (76.7% +/- 8.0% versus 82.4% +/- 5.8%; P clonidine premedication stabilizes hemodynamic variables during induction, maintenance, and emergence from anesthesia and reduces the amount of intraoperative anesthetics and postoperative opioids without deterioration of ventilation.

  10. Comparison of two different doses of magnesium sulphate for spinal anaesthesia.- A prospective, randomized double blind study

    Directory of Open Access Journals (Sweden)

    Hemalatha P

    2017-01-01

    Full Text Available Background: The present study aim was designed to compare and evaluate the efficacy of adding two different doses of magnesium sulphate to 0.5% hyperbaric levobupivacaine for spinal anaesthesia in terms of block characteristics, haemodynamic and safety profile. Methods: Ninety American Society of Anaesthesiologist (ASA grade I–II patients undergoing elective infra-umbilical surgeries under spinal anaesthesia were randomly allocated into three groups. Group C (n=30, control group received 3 mL (15 mg of 0.5% hyperbaric levobupivacaine; Group M50 (n=30: received 3 mL (15 mg of 0.5% hyperbaric levobupivacaine + 50 mg of magnesium sulphate. Group M100 (n=30 received 3 mL (15 mg of 0.5% hyperbaric levobupivacaine + 100 mg of magnesium sulphate.A standard protocol was followed after which a blinded observer assessed the sensory and motor blocks. The onset and duration of sensory (pin-prick block, onset, intensity and duration of motor block were recorded. Results: All the subarachnoid blocks were adequate. The addition of magnesium sulphate to intrathecal levobupivacaine had not only increased the time to onset of sensory block (p=0.007 but also prolonged the duration of sensory (p<0.001 and motor block (p<0.001 to statistically significant level in a dose dependent manner. Conclusions: Addition of magnesium sulphate does not offer any further advantage in terms of haemodynamic stability. However, it certainly increases the duration of sensory block to a significant level.

  11. A double-blind study on the effect of inhaled corticosteroids on plasma protein exudation in asthma.

    Science.gov (United States)

    Nocker, R E; Weller, F R; Out, T A; de Riemer, M J; Jansen, H M; van der Zee, J S

    1999-05-01

    Plasma protein exudation into the airways is an important pathophysiological event in asthma. The effect of 12 wk of treatment with inhaled fluticasone propionate (FP; 250 microgram twice a day) or salbutamol (Sb; 400 microgram twice a day) on plasma protein leakage was compared in a double-blind, randomized parallel-group study of 30 patients with asthma. Primary outcomes were plasma protein leakage and size selectivity of the blood-airway lumen barrier, cell differentials in BAL fluid, and bronchial responsiveness to histamine (PC20histamine). Two independent procedures to account for the effect of variable dilution of BAL on the levels of albumin (Alb) and alpha2-macroglobulin (A2M) in BAL fluid consisted of correction based on urea levels and on the application of the relative coefficient of excretion [RCE = ([A2M] in BAL fluid/[A2M] in serum)/([Alb] in BAL fluid/[Alb] in serum)]. In the FP group a significant decrease was found in the A2M level and the RCE, and in the percentage of eosinophils in BAL fluid. The PC20histamine increased significantly (mean increase, 2.4 doubling doses), whereas PC20histamine decreased in the Sb group. Differences between groups were significant except for the decrease in eosinophils. We conclude that 12 wk of FP (250 microgram twice a day) decreased the permeability of the blood-airway lumen barrier, in particular for high molecular weight proteins.

  12. Once-daily rupatadine improves the symptoms of chronic idiopathic urticaria: a randomised, double-blind, placebo-controlled study.

    Science.gov (United States)

    Dubertret, Louis; Zalupca, Lavinia; Cristodoulo, Tania; Benea, Vasile; Medina, Iris; Fantin, Sara; Lahfa, Morad; Pérez, Iñaki; Izquierdo, Iñaki; Arnaiz, Eva

    2007-01-01

    This randomised, double-blind, placebo-controlled, parallel-group, international, dose-ranging study investigated the effect of treatment with rupatadine 5, 10 and 20 mg once daily for 4 weeks on symptoms and interference with daily activities and sleep in 12-65 years-old patients with moderate-to-severe chronic idiopathic urticaria (CIU). Rupatadine 10 and 20 mg significantly reduced pruritus severity by 62.05% and 71.87% respectively, from baseline, over a period of 4 weeks compared to reduction with placebo by 46.59% (p < 0.05). Linear trends were noted for reductions in mean number of wheals and interference with daily activities and sleep with rupatadine 10 and 20 mg over the 4-week treatment period. The two most frequently reported AEs were somnolence (2.90% for placebo, 4.29% for 5 mg-, 5.41% for 10 mg- and 21.43% for 20 mg-rupatadine-treated group) and headache (4.35% for placebo, 2.86% for 5 mg-, 4.05% for 10 mg- and 4.29% for 20 mg-rupatadine-treated group). These findings suggest that rupatadine 10 and 20 mg is a fast-acting, efficacious and safe treatment for the management of patients with moderate-to-severe CIU. Rupatadine decreased pruritus severity, in a dose- and time-dependent manner.

  13. Is Skin-Touch Sham Needle Not Placebo? A Double-Blind Crossover Study on Pain Alleviation

    Directory of Open Access Journals (Sweden)

    Miho Takayama

    2015-01-01

    Full Text Available It remains an open question whether placebo/sham acupuncture, in which the needle tip presses the skin, can be used as a placebo device for research on pain. We compare the analgesic effect of the skin-touch placebo needle with that of the no-touch placebo needle, in which the needle tip does not touch the skin, in a double-blind crossover manner including no-treatment control in 23 healthy volunteers. The subjects received painful electrical stimulation in the forearm before and during needle retention to the LI 4 acupoint and after the removal of the needle and rated pain intensity using a visual analogue scale. We found no significant difference in analgesic effects among the skin-touch placebo needle, no-touch placebo needle, and no-treatment control at every point before, during, and after the treatments (p>0.05. The results indicate that the skin-touch placebo needle can be used as a placebo device in clinical studies on pain.

  14. 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.

  15. Conscious sedation during diagnostic endoscopic ultrasonography: A randomized, double-blind, controlled trial comparing midazolam with placebo

    OpenAIRE

    OĞUZ, Dilek; KÖKSAL, Aydın Şeref; ÇİÇEK, Bahattin; PARLAK, Erkan; ŞAHİN, Burhan

    2005-01-01

    Background/aim: There is no consensus regarding the application of conscious sedation in endoscopic procedures. In this prospective study we aimed to determine the necessity of applying sedation in diagnostic endoscopic ultrasonography. Materials and methods: Eighty patients who underwent endoscopic ultrasonography in Türkiye Yüksek İhtisas Hospital Gastroenterology Clinic were included in the study. Patients were separated into three groups depending on the region examined: esophagus ...

  16. [The preemptive action of ketoprofen. Randomized, double-blind study with gynecologic operations].

    Science.gov (United States)

    Likar, R; Krumpholz, R; Mathiaschitz, K; Pipam, W; Burtscher, M; Ozegovic, G; Breschan, C; Bernatzky, G; Sittl, R

    1997-03-01

    Ketoprofen exerts its clinical effect by inhibition of prostaglandin synthesis, but also acts as an NMDA-receptor antagonist by means of the kynurenic acid. Based on ketoprofen's supposed central mechanism of analgesia, we expected a preemptive effect, which was assessed by the present study. In a prospective, randomised, double-blind investigation of 48 patients undergoing gynaecological procedures (laparotomy, pelvioscopy), the first group received ketoprofen 2 mg/kg body weight i.v. 20 min before the beginning of surgery and placebo i.v. at the end of surgery. In the second group, placebo was administered first and ketoprofen at the end of surgery. Premedication and anaesthesia were standardised by protocol. The postoperative analgesic patient-controlled analgesia consumption by was also standardised (piritramide). Efficacy was assessed by visual analogue scale (VAS) and total requirement of analgesics within the first 24 postoperative hours. The time to the first request for postoperative analgesics was also recorded. Safety was assessed by continuous monitoring of vital parameters such as respiratory rate, heart rate, blood pressure, and oxygen saturation. The incidence and severity of adverse events was documented. There were no significant differences between the groups in demographic data or type or duration of surgery. The time to the first request for analgesic, VAS pain intensity, and analgesic consumption in the first 24 h post-surgery were not significantly different between the groups (t-test). Ketoprofen is an effective post-operative analgesic in combination with an opioid, but has no preemptive effect according to the results of this study.

  17. 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...

  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. 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.

  20. Magnetotactic bacteria and microjets: A comparative study

    NARCIS (Netherlands)

    Khalil, I.S.M.; Magdanz, Veronika; Sanchez, Samuel; Schmidt, Oliver G.; Misra, Sarthak

    2013-01-01

    We provide a comparative study between two self-propelled microrobots, i.e., magnetotactic bacteria and microjets. This study includes characterization of their fluidic properties (linear and rotational drag coefficients) based on their morphologies and characterization of their magnetic properties

  1. [Effect of chamomile on wound healing--a clinical double-blind study].

    Science.gov (United States)

    Glowania, H J; Raulin, C; Swoboda, M

    1987-09-01

    In a double-blind trial, the therapeutic efficacy of chamomile extract was tested on 14 patients. As objective parameters served the epithelial and drying effect on weeping wound area after dermabrasion of tattoos. The period of the healing and drying process was judged by the doctor. The decrease of the weeping wound area as well as the drying tendency was statistically significant.

  2. Parenting Experiences of Mothers Who Are Blind in Iran: A Hermeneutic Phenomenological Study

    Science.gov (United States)

    Moghadam, Zahra Behboodi; Ghiyasvandian, Shahrzad; Shahbazzadegan, Samira; Shamshiri, Mahmood

    2017-01-01

    Introduction: Mothers, who often serve as primary caregivers for their offspring, play a crucial role in the development of children. Understanding the parenting experiences of mothers who are blind can be valuable and beneficial for professional educators and health care workers who wish to provide holistic and appropriate services to both…

  3. A COMPARATIVE STUDY OF BYG SEARCH ENGINES

    Directory of Open Access Journals (Sweden)

    Kailash Kumar

    2013-01-01

    Full Text Available This paper compares the retrieval effectiveness of the Bing, Yahoo and Google (BYG Search Engines. The precision and relative recall of each search engine was considered for evaluating the effectiveness of the search engines. General Queries were tested. Results of the study showed that the precision of Google was high as compared to other two search engines and Yahoo has better precision than Bing

  4. Predictive performance of three multivariate difficult tracheal intubation models: a double-blind, case-controlled study.

    Science.gov (United States)

    Naguib, Mohamed; Scamman, Franklin L; O'Sullivan, Cormac; Aker, John; Ross, Alan F; Kosmach, Steven; Ensor, Joe E

    2006-03-01

    We performed a case-controlled, double-blind study to examine the performance of three multivariate clinical models (Wilson, Arné, and Naguib models) in the prediction of unanticipated difficult intubation. The study group consisted of 97 patients in whom an unanticipated difficult intubation had occurred. For each difficult intubation patient, a matched control patient was selected in whom tracheal intubation had been easily accomplished. Postoperatively, a blinded investigator evaluated both patients. The clinical assessment included the patient's weight, height, age, Mallampati score, interincisor gap, thyromental distance, thyrosternal distance, neck circumference, Wilson risk sum score, history of previous difficult intubation, and diseases associated with difficult laryngoscopy or intubation. The Naguib model was significantly more sensitive (81.4%; P thyromental distance, Mallampati score, interincisor gap, and height. This model is 82.5% sensitive and 85.6% specific with an area under the receiver operating characteristic curve of 0.90.

  5. A phase III randomized, double-blind, placebo-controlled study of pilocarpine for vaginal dryness: North Central Cancer Treatment group study N04CA.

    Science.gov (United States)

    Loprinzi, Charles L; Balcueva, Ernie P; Liu, Heshan; Sloan, Jeff A; Kottschade, Lisa A; Stella, Philip J; Carlson, Mark D; Moore, Dennis F; Zon, Robin T; Levitt, Ralph; Jaslowski, Anthony J

    2011-01-01

    Vaginal dryness is a common problem for which effective and safe nonestrogenic treatments are needed. Based on preliminary promising data that pilocarpine attenuated vaginal dryness, the current trial was conducted. A double-blind, placebo-controlled, randomized trial design was used to compare pilocarpine, at target doses of 5 mg twice daily and 5 mg four times daily, with a placebo. Vaginal dryness was recorded by patient-completed questionnaires at baseline and weekly for 6 weeks after study initiation. The primary endpoint for this study was the area under the curve summary statistic composed of the longitudinal responses obtained at baseline and through the 6 weeks of treatment to a numerical analogue scale asking patients to rate their perceived amount of vaginal dryness. The primary analysis was carried out by a single t test using a two-side alternative to compare the collective pilocarpine treatment arms with the collective placebo arms. A total of 201 patients enrolled in this trial. The primary analysis, comparing vaginal dryness symptoms in the collective pilocarpine arms against the placebo arm, did not reveal any benefit for the pilocarpine treatment. This finding was confirmed by other secondary analyses. Toxicity evaluation revealed more nausea, sweating, rigors, and urinary frequency with the pilocarpine arms compared with the placebo arm.

  6. 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

  7. Lurasidone for the Treatment of Major Depressive Disorder With Mixed Features: A Randomized, Double-Blind, Placebo-Controlled Study.

    Science.gov (United States)

    Suppes, Trisha; Silva, Robert; Cucchiaro, Josephine; Mao, Yongcai; Targum, Steven; Streicher, Caroline; Pikalov, Andrei; Loebel, Antony

    2016-04-01

    Accumulating evidence indicates that manic symptoms below the threshold for hypomania (mixed features) are common in individuals with major depressive disorder. This form of depression is often severe and is associated with an increased risk for recurrence, suicide attempts, substance abuse, and functional disability. This study evaluated the efficacy and safety of lurasidone in major depressive disorder with mixed features. Patients meeting DSM-IV-TR criteria for major depressive disorder who presented with two or three protocol-defined manic symptoms were randomly assigned to 6 weeks of double-blind treatment with either lurasidone at 20-60 mg/day (N=109) or placebo (N=100). Changes from baseline in Montgomery-Åsberg Depression Rating Scale score (MADRS; primary outcome measure) and Clinical Global Impressions severity subscale score (CGI-S; key secondary outcome measure) were evaluated using a mixed model for repeated-measures analysis. Lurasidone significantly improved depressive symptoms and overall illness severity, assessed by least squares mean change at week 6 in the MADRS and CGI-S scores: -20.5 compared with -13.0 (effect size, 0.80) and -1.8 compared with -1.2 (effect size, 0.60), respectively. Significant improvement in manic symptoms, assessed by the Young Mania Rating Scale, was also observed, in addition to other secondary efficacy endpoints. Rates of discontinuation due to adverse events were low. The most common adverse events were nausea (6.4% and 2.0% in the lurasidone and placebo groups, respectively) and somnolence (5.5% and 1.0%). Lurasidone was effective and well tolerated in this study involving patients with major depressive disorder associated with subthreshold hypomanic symptoms (mixed features).

  8. A Prospective, Randomized, Double-Blind Study of Coblation versus Dissection Tonsillectomy in Adult Patients.

    Science.gov (United States)

    Rakesh, Singh; Anand, T S; Payal, Garg; Pranjal, Kulshreshtha

    2012-09-01

    This randomized double blind study was conducted prospectively to determine whether coblation tonsillectomy fared better than the conventional dissection method in terms of postoperative pain, bleeding, and rapidity of healing in adult Indian patients undergoing tonsillectomy. Sixty adult patients undergoing tonsillectomy for benign indications were randomized to have one tonsil removed by subcapsular radiofrequency ablation method and the other by conventional dissection method. The operative time and blood loss was noted for each side. Patients were evaluated at 6, 12, 24, 48, 72 h and then on 7th and 20th postoperative day for postoperative pain (by visual analog scale), bleeding, and tonsillar fossa healing. Statistical comparison was done using appropriate tests. The two groups were demographically matched. It took longer to perform the coblation procedure (15 vs 11 min) (P > 0.05). The operative blood loss on the radiofrequency side was 11 ml, vs 34 ml on the conventional side (P = 0.009). 77% patients said that the coblation side was less painful for the overall 20-day recovery period. There were significant differences seen at 6, 12, 24, 48, and 72 h in terms of postoperative pain scores. Beyond that, the pain was consistently less on the coblation side, but the difference was not significant. There was no case of reactionary or secondary hemorrhage in either arm. The healing took longer on the radiofrequency side. Coblation tonsillectomy is an easy to learn technique with significantly reduced operative blood loss and postoperative pain. Longer operative times maybe further reduced with experience.

  9. 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.

  10. 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.

  11. Memantine add on to citalopram in elderly patients with depression: A double-blind placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Victoria Omranifard

    2014-01-01

    Full Text Available Background: Proper management of depression in elderly population would improve the outcome of the disease and reduce its related disability and mortality. Use of memantine with minimal side effects and drug interaction seems reasonable in the elderly but its antidepressant activity is controversial. The aim of the current research is to investigate the effects of add-on memantine during citalopram therapy in elderly patients with depression, in Isfahan. Materials and Methods: In this double-blind, placebo controlled trial study; elderly patients aged more than 60 years who were recently diagnosed with depression, were enrolled. The selected patients were randomlysplit into two groups, viz. intervention and placebo groups. The intervention was memantine (20 mg daily or identical placebo plus citalopram for 8 weeks. The severity of depression and quality of life was evaluated using Geriatric Depression Scale (GDS-15, Hamilton Rating Scale for depression (HRSD and World Health Organization Quality of Life WHOQOL-BREF respectively. The mentioned scores were evaluated at baseline, 4 weeks and 8 weeks, after initiating the trial in two studied groups and compared with each other. Results: 28 and 29 patients were studied in the intervention and placebo groups, respectively. Score of GDS-15, HRSD and WHO-QOL-BREF scales at baseline, 4 weeks and 8 weeks, after initiating trial did not change significantly after use of memantine (P > 0.05. There was no significant difference in mean +/- SD of GDS-15, HRSD and WHO-QOL-BREF scales among intervention and placebo groups (P > 0.05. Conclusion: The outcome of this clinical trial did not support the antidepressant effect of add-on memantine in elderly patients with depression receiving citalopram. It is recommended to design further studies considering the limitations of the current study mentioned herein and the effect of memantine with other anti-depressant agents.

  12. Extended analysis of a double-blind, placebo-controlled, 15-week study with otilonium bromide in irritable bowel syndrome.

    Science.gov (United States)

    Glende, Manfred; Morselli-Labate, Antonio M; Battaglia, Giuseppe; Evangelista, Stefano

    2002-12-01

    In order to follow the most recent developments and recommendations in trial methodology for drug evaluation in patients with irritable bowel syndrome, we performed an extended analysis of a large clinical trial from a previously published study of otilonium bromide, using an assessment that integrates the key symptoms of irritable bowel syndrome. A large-scale clinical trial with a double-blind, placebo-controlled, parallel-group study design was conducted in 378 patients, treated for 15 weeks with the recommended standard dose of 40 mg otilonium bromide or placebo three times daily. The study was based on the collection of 12 single efficacy endpoints. The new efficacy assessment was based on the data reported by the patients. Rather than demonstrating score differences between the treatment groups of the study, we carried out an assessment that integrates the most frequent symptoms reported (pain frequency and intensity, presence of meteorism and distension) by the patient. The rate of response to treatment within 2-4 months (the primary efficacy outcome measure) was significantly higher in the otilonium bromide group (36.9%) than in the placebo group (22.5%; P = 0.007). In each month of treatment, the rate of monthly response was higher in the otilonium bromide group as compared to the placebo group (P otilonium bromide than in the placebo-treated group, with differences ranging from 10% to 20%. The subgroup analysis of the intestinal habits endpoint indicates that patients with diarrhoea have an additional benefit. The present re-evaluation of a previously published study confirms that otilonium bromide is more effective than placebo for the treatment of irritable bowel syndrome, being very efficient in relieving pain and discomfort.

  13. A multicenter, randomized, double-blind comparison of roxatidine with ranitidine in the treatment of patients with uncomplicated benign gastric ulcer disease. The Multicenter Roxatidine Cooperative Study Group.

    Science.gov (United States)

    Brandstätter, G; Marks, I N; Lanza, F; Kogut, D; Cobert, B; Savitsky, J P; Bender, W; Labs, R; Wurzer, H

    1995-01-01

    Roxatidine (150 mg, 312 patients) was compared with ranitidine (300 mg, 308 patients) in a randomized, double-blind, parallel-group, 6-week therapeutic study for the treatment of patients with uncomplicated, benign gastric ulcer disease. The study end points (verified by using endoscopy results) were fully healed ulcers at 4 or 6 weeks. The results of roxatidine therapy were comparable to those of ranitidine therapy: healing rates of 52% and 54% at week 4 and 77% and 76% at week 6 were recorded for roxatidine and ranitidine, respectively. The drugs produced comparable reductions in ulcer diameters and decreases in abdominal pain. Adverse events associated with both roxatidine (27%) and ranitidine (28%) were headache, diarrhea, and dizziness; rash was associated in 6 of 8 cases and in only 1 case with roxatidine. In this trial, roxatidine 150 mg once daily was as efficacious and safe as ranitidine 300 mg once daily for treatment of patients with uncomplicated, benign gastric ulcer disease.

  14. A randomised, double- blind, cross-over study investigating the prebiotic effect of agave fructans in healthy human subjects

    OpenAIRE

    Ramnani, Priya; Costabile, Adele; Bustillo, A. G. R.; Gibson, Glenn R.

    2015-01-01

    This placebo-controlled, randomised, double-blind, cross-over human feeding study aimed to determine the prebiotic effect of agave fructans. A total of thirty-eight volunteers completed this trial. The treatment consisted of 3 weeks' supplementation with 5 g/d of prebiotic agave fructan (Predilife) or equivalent placebo (maltodextrin), followed by a 2-week washout period following which subjects were crossed over to alternate the treatment arm for 3 weeks followed by a 2-week washout. Faecal ...

  15. A New Method for Sham-Controlled Acupuncture in Experimental Visceral Pain - a Randomized, Single-Blinded Study.

    Science.gov (United States)

    Juel, Jacob; Liguori, Stefano; Liguori, Aldo; Valeriani, Massimiliano; Graversen, Carina; Olesen, Søren S; Drewes, Asbjørn M

    2016-07-01

    Acupuncture is increasingly used as an alternative to medical therapy for various pain conditions. To study the effect of acupuncture in experimental and clinical studies, a control condition with sham acupuncture is needed. However, as such models have not been established in assessment of acupunctures effect against visceral pain, this study aimed to validate a new method for blinded sham acupuncture in experimental rectal pain. Fifteen subjects underwent a sequence of either sham or real acupuncture in randomized order. In the sham arm, a hollow inner tube with a sharp tip was fitted into an outer tube and subjects were blinded to the stimulations. Before and after the intervention, pain was induced by rectal stimulation with an inflatable balloon distended until the subjects' pain threshold was reached. The resting electroencephalogram (EEG) was quantified by spectral power analysis to explore the central nervous system effects objectively. Additionally, after the second study day, the subject was asked to indicate the sequence of interventions. A significant increase in rectal balloon volume was observed after sham 12 ± 21 mL (P = 0.049) and acupuncture 17 ± 30 mL (P = 0.046). However, the change in volume was not different between groups (P = 0.6). No differences in EEG spectral power distributions between sham and acupuncture were seen (all P > 0.6). The correct sequence of sham and acupuncture was indicated by 36% of the subjects (P = 0.4). The presented sham procedure provides a valid method for blinding of "sham acupuncture" and may be used in future blinded controlled trials of acupuncture for visceral pain. © 2015 World Institute of Pain.

  16. A prospective double-blind randomized controlled trial comparing the suitability of KTP laser tonsillectomy with conventional dissection tonsillectomy for day case surgery.

    Science.gov (United States)

    Kothari, P; Patel, S; Brown, P; Obara, L; O'Malley, S

    2002-10-01

    Tonsillectomy using a KTP laser has been performed increasingly but is not a routinely practised technique in the UK. In the USA, tonsillectomy is often performed as a day case procedure but, here in the UK, it is still standard practice to admit patients for overnight stay. We present the largest prospective double-blind randomized controlled trial to date (151 patients) comparing KTP laser with standard dissection tonsillectomy and assess the suitability of both procedures for day case surgery. We found that there was significantly less peroperative haemorrhage if tonsillectomy was performed using the KTP laser, but it did cause more postoperative pain, more depression in mood and a higher rate of both reactionary and secondary haemorrhage, which was not significant when compared with conventional dissection. There was no difference in operating time, and over 40% of patients in each group needed overnight admission. We conclude that KTP laser tonsillectomy offers no benefit apart from less intraoperative bleeding over standard dissection tonsillectomy. Discharge from hospital after tonsillectomy was found to be unpredictable. Tonsillectomy is therefore an unsuitable procedure for planned surgery through a day unit, but approximately 58% of patients could be discharged on the same day from an extended day surgery unit, and the rest have one night in hospital.

  17. Treatment of Vertigo: A Randomized, Double-Blind Trial Comparing Efficacy and Safety of Ginkgo biloba Extract EGb 761 and Betahistine

    Directory of Open Access Journals (Sweden)

    Larysa Sokolova

    2014-01-01

    Full Text Available A multicenter clinical trial was performed to compare the efficacy and safety of Ginkgo biloba extract EGb 761 and betahistine at recommended doses in patients with vertigo. One hundred and sixty patients (mean age 58 years were randomly assigned to double-blind treatment with EGb 761 (240 mg per day or betahistine (32 mg per day for 12 weeks. An 11-point numeric analogue scale, the Vertigo Symptom Scale—short form, the Clinical Global Impression Scales and the Sheehan Disability Scale were used as outcome measures. Both treatment groups were comparable at baseline and improved in all outcome measures during the course of treatment. There was no significant intergroup difference with regard to changes in any outcome measure. Numerically, improvements of patients receiving EGb 761 were slightly more pronounced on all scales. Clinical global impression was rated “very much improved” or “much improved” in 79% of patients treated with EGb 761 and in 70% receiving betahistine. With 27 adverse events in 19 patients, EGb 761 showed better tolerability than betahistine with 39 adverse events in 31 patients. In conclusion, the two drugs were similarly effective in the treatment of vertigo, but EGb 761 was better tolerated. This trial is registered with controlled-trials.com ISRCTN02262139.

  18. Treatment of Vertigo: A Randomized, Double-Blind Trial Comparing Efficacy and Safety of Ginkgo biloba Extract EGb 761 and Betahistine.

    Science.gov (United States)

    Sokolova, Larysa; Hoerr, Robert; Mishchenko, Tamara

    2014-01-01

    A multicenter clinical trial was performed to compare the efficacy and safety of Ginkgo biloba extract EGb 761 and betahistine at recommended doses in patients with vertigo. One hundred and sixty patients (mean age 58 years) were randomly assigned to double-blind treatment with EGb 761 (240 mg per day) or betahistine (32 mg per day) for 12 weeks. An 11-point numeric analogue scale, the Vertigo Symptom Scale-short form, the Clinical Global Impression Scales and the Sheehan Disability Scale were used as outcome measures. Both treatment groups were comparable at baseline and improved in all outcome measures during the course of treatment. There was no significant intergroup difference with regard to changes in any outcome measure. Numerically, improvements of patients receiving EGb 761 were slightly more pronounced on all scales. Clinical global impression was rated "very much improved" or "much improved" in 79% of patients treated with EGb 761 and in 70% receiving betahistine. With 27 adverse events in 19 patients, EGb 761 showed better tolerability than betahistine with 39 adverse events in 31 patients. In conclusion, the two drugs were similarly effective in the treatment of vertigo, but EGb 761 was better tolerated. This trial is registered with controlled-trials.com ISRCTN02262139.

  19. Reporting on blinding in trial protocols and corresponding publications was often inadequate but rarely contradictory

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Pildal, Julie; Chan, An-Wen

    2009-01-01

    OBJECTIVE: To compare the reporting on blinding in protocols and articles describing randomized controlled trials. STUDY DESIGN AND SETTING: We studied 73 protocols of trials approved by the scientific/ethical committees for Copenhagen and Frederiksberg, 1994 and 1995, and their corresponding...... publications. RESULTS: Three out of 73 trials (4%) reported blinding in the protocol that contradicted that in the publication (e.g., "open" vs. "double blind"). The proportion of "double-blind" trials with a clear description of the blinding of participants increased from 11 out of 58 (19%) when based...... on publications alone to 39 (67%) when adding the information in the protocol. The similar proportions for the blinding of health care providers were 2 (3%) and 22 (38%); and for the blinding of data collectors, they were 8 (14%) and 14 (24%). In 52 of 58 publications (90%), it was unclear whether all patients...

  20. Prophylactic use of gabapentin for prevention of succinylcholine-induced fasciculation and myalgia: A randomized, double-blinded, placebo-controlled study

    Directory of Open Access Journals (Sweden)

    C K Pandey

    2012-01-01

    Full Text Available Background: Succinylcholine is used for rapid-sequence induction of anesthesia. Fasciculations and myalgia are adverse effects. The pretreatment modalities prevent or minimize its adverse effects. Aims: The present study is designed to evaluate the efficacy of gabapentin on the incidence of fasciculation and succinylcholine-induced myalgia. Settings and Design: The study was conducted at a tertiary care teaching hospital in a randomized, double-blinded, placebo-controlled manner. Materials and Methods: Patients of both genders undergoing laparoscopic cholecystectomy were randomly assigned to two groups. Patients in Group I (Gabapentin group received 600 mg of gabapentin orally 2 h prior to surgery and patients in Group II (placebo group received matching placebo. Anesthesia was induced with fentanyl 3 μg/kg, thiopentone 3-5 mg/kg and succinylcholine 1.5 mg/kg. All patients were observed and graded for fasciculations by a blinded observer and patients were intubated. Anesthesia was maintained with oxygen in air, sevoflurane and intermittent vecuronium bromide. After completion of surgery, neuromuscular blockade was reversed. A blinded observer recorded myalgia grade at 24 h. Patients were provided patient-controlled analgesia with fentanyl for postoperative pain relief. Statistical analysis: Demographic data, fasciculation grade, fentanyl consumption, and myalgia grade were compared using student t test and test of proportions. Results: The study included 76 American Society of Anesthesiologists′ Grade I or II patients of either gender undergoing laparoscopic cholecystectomy. But only 70 patients completed the study. Results demonstrated that the prophylactic use of gabapentin significantly decreases the incidence and the severity of myalgia (20/35 vs. 11/35 (P<0.05 and decreases fentanyl consumption significantly in the study group (620+164 μg vs. 989+238 μg (P<0.05 without any effects on the incidence and severity of fasciculations